UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
(Mark One)
☒
☐
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2016
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number: 001-34263
Impax Laboratories, Inc.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)
Delaware
65-0403311
30831 Huntwood Avenue, Hayward, CA
(Address of principal executive offices)
94544
(Zip Code)
Registrant’s telephone number, including area code:
(510) 476-2000
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common Stock, par value $0.01 per share
Name of each exchange on which registered:
The NASDAQ Stock Market LLC
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes ☒ No ☐
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.
Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the
past 90 days.
Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit
and post such files).
Yes ☒ No ☐
1
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation of S-K is not contained herein, and will not be contained, to the best of
registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.
☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the
definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer ☒
Accelerated filer ☐
Non-accelerated filer ☐
Smaller reporting company ☐
(Do not check if a smaller reporting company)
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).
Yes ☐ No ☒
The aggregate market value of the registrant’s outstanding shares of common stock, other than shares held by persons who may be deemed affiliates of the
registrant, computed by reference to the price at which the registrant’s common stock was last sold on The NASDAQ Stock Market LLC as of the last business day
of the registrant’s most recently completed second fiscal quarter ( June 30, 2016 ), was approximately $ 1,864,428,000 .
As of February 17, 2017 , there were 73,748,155 shares of the registrant’s common stock outstanding.
Certain portions of the definitive proxy statement for the registrant’s Annual Meeting of Stockholders to be held on May 16, 2017 have been incorporated by
reference into Part III of this Annual Report on Form 10-K.
DOCUMENTS INCORPORATED BY REFERENCE
2
Forward-Looking Statements
TABLE OF CONTENTS
PART I.
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
PART II.
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
PART III.
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
PART IV.
Business
Risk Factors
Unresolved Staff Comments
Properties
Legal Proceedings
Mine Safety Disclosures
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Selected Financial Data
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures about Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accounting Fees and Services
Item 15.
Exhibits and Financial Statement Schedules
SIGNATURES
EXHIBIT INDEX
3
4
5
18
40
40
41
41
42
44
45
71
72
72
72
75
76
76
76
76
76
77
Forward-Looking Statements
Statements included in this Annual Report on Form 10-K that do not relate to present or historical conditions are “forward-looking statements.” Such
forward-looking statements involve risks and uncertainties that could cause results or outcomes to differ materially from those expressed in the forward-looking
statements. Forward-looking statements may include statements relating to our plans, strategies, objectives, expectations and intentions. Words such as “believes,”
“forecasts,” “intends,” “possible,” “estimates,” “anticipates,” and “plans” and similar expressions are intended to identify forward-looking statements. Our ability
to predict results or the effect of events on our operating results is inherently uncertain. Forward-looking statements involve a number of risks, uncertainties and
other factors that could cause actual results to differ materially from those discussed in this Annual Report on Form 10-K. Such risks and uncertainties include, but
are not limited to, fluctuations in our operating results and financial condition, the volatility of the market price of our common stock, our ability to successfully
develop and commercialize pharmaceutical products in a timely manner, the impact of competition, the effect of any manufacturing or quality control problems,
our ability to manage our growth, risks related to acquisitions of or investments in technologies, products or businesses, risks relating to goodwill and intangibles,
the reduction or loss of business with any significant customer, the substantial portion of our total revenues derived from sales of a limited number of products, the
impact of consolidation of our customer base, our ability to sustain profitability and positive cash flows, the impact of any valuation allowance on our deferred tax
assets, the restrictions imposed by our credit facility and indenture, our level of indebtedness and liabilities and the potential impact on cash flow available for
operations, the availability of additional funds in the future, any delays or unanticipated expenses in connection with the operation of our manufacturing facilities,
the effect of foreign economic, political, legal and other risks on our operations abroad, the uncertainty of patent litigation and other legal proceedings, the
increased government scrutiny on our agreements to settle patent litigations, product development risks and the difficulty of predicting FDA filings and approvals,
consumer acceptance and demand for new pharmaceutical products, the impact of market perceptions of us and the safety and quality of our products, our
determinations to discontinue the manufacture and distribution of certain products, our ability to achieve returns on our investments in research and development
activities, changes to FDA approval requirements, our ability to successfully conduct clinical trials, our reliance on third parties to conduct clinical trials and
testing, our lack of a license partner for commercialization of Numient ® (IPX066) outside of the United States, impact of illegal distribution and sale by third
parties of counterfeits or stolen products, the availability of raw materials and impact of interruptions in our supply chain, our policies regarding returns, rebates,
allowances and chargebacks, the use of controlled substances in our products, the effect of current economic conditions on our industry, business, results of
operations and financial condition, disruptions or failures in our information technology systems and network infrastructure caused by third party breaches or other
events, our reliance on alliance and collaboration agreements, our reliance on licenses to proprietary technologies, our dependence on certain employees, our
ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment, the effect of certain provisions in our
government contracts, our ability to protect our intellectual property, exposure to product liability claims, changes in tax regulations, uncertainties involved in the
preparation of our financial statements, our ability to maintain an effective system of internal control over financial reporting, the effect of terrorist attacks on our
business, the location of our manufacturing and research and development facilities near earthquake fault lines, expansion of social media platforms and other risks
described below in “Item 1A. Risk Factors.” You should not place undue reliance on forward-looking statements. Such statements speak only as to the date on
which they are made, and we undertake no obligation to update or revise any forward-looking statement, regardless of future developments or availability of new
information.
Rytary® and Emverm® are registered trademarks of Impax Laboratories, Inc. Other names are for informational purposes only and are used to identify
companies and products and may be trademarks of their respective owners.
4
Item 1. Business
Overview
PART I.
We are a specialty pharmaceutical company applying formulation and development expertise, as well as our drug delivery technology, to the
development, manufacture and marketing of bioequivalent pharmaceutical products, commonly referred to as “generics,” in addition to the development,
manufacture and marketing of branded products. We operate in two segments, referred to as “Impax Generics” and “Impax Specialty Pharma.” The Impax
Generics division includes our legacy Global Pharmaceuticals business as well as the acquired businesses of CorePharma, LLC ("CorePharma") and Lineage
Therapeutics, Inc. ("Lineage") from our acquisition of Tower Holdings, Inc. ("Tower") and its subsidiaries on March 9, 2015 (the "Tower Acquisition"). The
Impax Specialty Pharma division includes our legacy Impax Pharmaceuticals business as well as the acquired business of Amedra Pharmaceuticals, LLC
("Amedra") from the Tower Acquisition. Impax Generics concentrates its efforts on generic products, which are the pharmaceutical and therapeutic equivalents of
brand-name drug products and are usually marketed under their established nonproprietary drug names rather than by a brand name. Impax Specialty Pharma
utilizes its specialty sales force to market proprietary branded pharmaceutical products for the treatment of central nervous system (“CNS”) disorders and other
select specialty segments. Impax Specialty Pharma also generated revenue from research and development services provided to an unrelated third-party
pharmaceutical entity (which agreement was terminated by mutual agreement of the parties effective December 23, 2015). See “Item 15. Exhibits and Financial
Statement Schedules — Note 23. Segment Information,” for financial information about our segments for the years ended December 31, 2016 , 2015 and 2014 .
Our Strategy
We plan to continue to expand our Impax Generics division by targeting complex solid oral and alternative dosage form Abbreviated New Drug
Applications (“ANDAs”) with high revenue potential, including products with the potential to be first-to-file or first-to-market. Our products and product
candidates are generally difficult to formulate and manufacture, providing certain competitive advantages. In addition to our product pipeline of 25 pending
applications at the FDA as of December 31, 2016 , we are continuing to evaluate and pursue external growth initiatives including acquisitions and partnerships. For
instance, during 2016, we completed the acquisition of certain assets, including marketed and pipeline generic products, from Teva Pharmaceutical Industries Ltd.
(acting directly or through its affiliates) and affiliates of Allergan plc (the "Teva Transaction"). Refer to "Item 15. Exhibits and Financial Statement Schedules -
Note 2. Business Acquisitions" for more information on the Teva Transaction.
The following information summarizes our generic pharmaceutical product development activities since inception through December 31, 2016 :
•
•
•
136 ANDAs approved by the U.S. Food and Drug Administration (“FDA”), including four tentatively approved (i.e., satisfying substantive FDA
requirements but remaining subject to statutory restrictions). In addition, we have rights to market and/or share in profits to 16 approved ANDAs held
by our third party alliance partners. The approved ANDAs (including those held by our partners) include generic versions of brand name
pharmaceuticals such as Adderall XR®, Lofibra®, Opana ER® (NDA 021610), Pulmicort Respules® and Solaraze®.
25 applications pending at the FDA that represent approximately $14 billion in 2016 U.S. product sales.
A number of products in various stages of development for which applications have not yet been filed.
A core component of our strategy includes an ongoing focus in our Impax Specialty Pharma division on proprietary brand-name pharmaceutical products
to treat CNS disorders and other specialty segments. We believe that we have the research, development and formulation expertise to develop branded products
that will deliver significant improvements over existing therapies. We plan to continue investing in our development pipeline, both internally and through
acquisitions and partnerships primarily focused on late-stage and next generation product opportunities.
5
Impax Generics Division
In the generic pharmaceutical market, we focus our efforts on developing, manufacturing, selling and distributing complex solid dose and alternative
dosage form products covering a broad range of therapeutic areas and having technically challenging drug-delivery mechanisms or unique product development
formulations. We employ our technologies and formulation expertise to develop generic products that reproduce brand-name products’ physiological
characteristics but do not infringe any valid patents relating to such brand-name products. Generic products contain the same active ingredient and are of the same
route of administration, dosage form, strength and indication(s) as brand-name products already approved for use in the United States by the FDA. We generally
focus our generic product development on brand-name products as to which the patents covering the active pharmaceutical ingredient have expired or are near
expiration, and we employ our experience to develop bioequivalent versions of such brand-name products. We also develop, manufacture, sell and distribute
specialty generic pharmaceuticals that we believe present certain competitive advantages, such as difficulty in raw materials sourcing, complex formulation or
development characteristics or special handling requirements. We have generally obtained rights to our alternative dosage form products through third party
alliance and collaboration agreements, such as through our partnership agreement with Tolmar, Inc. (“Tolmar”).
We sell and distribute generic pharmaceutical products primarily through four sales channels:
•
•
•
•
the “Impax Generics sales channel" for sales of generic prescription products we sell directly to wholesalers, large retail drug chains, and others;
the “Private Label sales channel" for generic pharmaceutical over-the-counter (“OTC”) and prescription products we sell to unrelated third party
customers who in-turn sell the product to third parties under their own label;
the “Rx Partner sales channel" for generic prescription products sold through unrelated third-party pharmaceutical entities under their own label
pursuant to alliance agreements; and
the “OTC Partner sales channel" for sales of generic pharmaceutical OTC products sold through unrelated third-party pharmaceutical entities under
their own label pursuant to alliance agreements.
As of December 31, 2016 , we marketed 207 generic pharmaceutical products representing dosage variations of 72 different pharmaceutical compounds
through our Impax Generics division, and five other generic pharmaceutical products, representing dosage variations of two different pharmaceutical compounds,
through our alliance and collaboration agreement partners. As of December 31, 2016 , our significant marketed generic products were Epinephrine Auto-Injector
(generic Adrenaclick®), oxymorphone hydrochloride extended release tablets (AB rated to original OPANA® ER), diclofenac sodium gel 3% (generic
Solaraze®), and fenofibrate (generic Lofibra®).
As of December 31, 2016 , we had 25 applications pending at the FDA. The following table lists our publicly identified product applications pending at
the FDA as of December 31, 2016 :
Product
Aspirin/Dipyridamole ER Capsules 25/200 mg
Colesevelam Tablets 625 mg
Dutasteride/Tamsulosin Capsules 0.5 mg/0.4 mg
Ezetimbe/Simvastatin Tablets 10/10 mg, 10/20mg, 10/40 mg, 10/80 mg
Fentanyl Buccal Tablet 100, 200, 400, 600, 800 mcg
Methylphenidate HCl ER Tablets 18, 27, 36, 54 mg
Mixed Amphetamine Salts ER Capsules 5, 10, 15, 20, 25, 30 mg
Oxycodone ER Tablets (new formulation) 10, 15, 20, 30, 40, 60, 80 mg
Oxymorphone ER Tablets version 5, 7.5, 10, 15, 20, 30 and 40 mg (new formulation)
Risedronate Sodium DR Tablets 35 mg
Sevelamer Carbonate Tablets 800 mg
Teriflunomide Tablets 14 mg
6
Generic of
Aggrenox®
Welchol®
Jalyn®
Vytorin®
Fentora®
Concerta®
Adderall XR®
Oxycontin®
Opana® ER
Atelvia®
Renvela®
Aubagio®
Impax Specialty Pharma
Impax Specialty Pharma is engaged in the development, sale and distribution of proprietary branded pharmaceutical products that we believe represent
improvements to already-approved pharmaceutical products addressing CNS disorders and other select specialty segments. We estimate there are approximately
16,000 neurologists in the United States. Historically, a concentrated number of these neurologists are responsible for writing the majority of neurology
prescriptions. CNS is the largest therapeutic category in the United States with 2016 sales of about $69.3 billion, or 15.4% of the $450 billion U.S. prescription
drug market. CNS product sales contracted -3.7% in 2016 , compared to 6% growth for the overall pharmaceutical market, while total CNS prescriptions increased
1.6%, slightly less than the overall pharmaceutical industry growth rate of 2%. (Source: IMS Health).
Our branded pharmaceutical product portfolio consists of commercial CNS and other select specialty products, as well as development stage projects. In
February 2012, we licensed from AstraZeneca UK Limited ("AstraZeneca") the exclusive U.S. commercial rights to Zomig® (zolmitriptan) tablet, orally
disintegrating tablet and nasal spray formulations pursuant to the terms of a Distribution, License, Development and Supply Agreement with AstraZeneca, which
was subsequently amended (the "AZ Agreement") and began sales of the Zomig® products under our label during the year ended December 31, 2012 through our
specialty sales force. In May 2013, our exclusivity period for branded Zomig® tablets and orally disintegrating tablets expired and we launched authorized generic
versions of those products in the United States. In June 2015, the FDA approved the Zomig® nasal spray for use in pediatric patients 12 years of age or older for
the acute treatment of migraine with or without aura. In addition to the Zomig® products and our internally developed pharmaceutical product, Rytary® for the
treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication,
which was approved by the FDA on January 7, 2015, we are currently engaged in the sales and marketing of Emverm ® (mebendazole) 100 mg chewable tablets,
indicated for the treatment of pinworm, whipworm, common roundworm, common hookworm, and two other products, all acquired in our acquisition of Tower
and Lineage which closed in March 2015. In November 2015, the European Commission granted marketing authorization for Numient® (referred to as Rytary® in
the United States). The review of the Numient® application was conducted under the centralized licensing procedure as a therapeutic innovation, and the
authorization is applicable in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
We have a couple of product candidates that are in varying stages of development and we currently intend to expand our portfolio of branded
pharmaceutical products primarily through internal development and through licensing and acquisitions, with a focus on late-stage product opportunities.
Alliance and Collaboration Agreements
We have entered into several alliance, collaboration or license and distribution agreements with respect to certain of our products and services and may
enter into similar agreements in the future. These agreements typically obligate us to deliver multiple goods and/or services over extended periods. Such
deliverables include manufactured pharmaceutical products, exclusive and semi-exclusive marketing rights, distribution licenses, and research and development
services. Our alliance and collaboration agreements often include milestones and provide for payments upon achievement of these milestones. For more
information about the types of milestone events in our agreements and how we categorize them, see “Item 15. Exhibits and Financial Statement Schedules — Note
20. Alliance and Collaboration Agreements.”
Impax Generics Division – Alliance and Collaboration Agreements
License and Distribution Agreement with Shire
In January 2006, we entered into a License and Distribution Agreement with an affiliate of Shire Laboratories, Inc., which was subsequently amended
(“Prior Shire Agreement”), under which we received a non-exclusive license to market and sell an authorized generic of Shire’s Adderall XR® product (“AG
Product”) subject to certain conditions, but in any event by no later than January 1, 2010. We commenced sales of the AG Product in October 2009. On February 7,
2013, we entered into an Amended and Restated License and Distribution Agreement with Shire (the “Amended and Restated Shire Agreement”), which amended
and restated the Prior Shire Agreement. The Amended and Restated Shire Agreement was entered into by the parties in connection with the settlement of our
litigation with Shire relating to Shire’s supply of the AG Product to us under the Prior Shire Agreement. Under the Amended and Restated Shire Agreement, Shire
was required to supply the AG Product and we were responsible for marketing and selling the AG Product subject to the terms and conditions thereof until the
earlier of (i) the first commercial sale of our generic equivalent product to Adderall XR® and (ii) September 30, 2014 (the “Supply Term”), subject to certain
continuing obligations of the parties upon expiration or early termination of the Supply Term, including Shire’s obligation to deliver AG Products still owed to us
as of the end of the Supply Term. We are required to pay a profit share to Shire on sales of the AG Product, of which we owed a profit share payable to Shire of
$7.5 million , $19.5 million and $21.1 million on sales of the AG Product
7
during the years ended December 31, 2016 , 2015 and 2014 , respectively, with a corresponding charge included in the cost of revenues line in the consolidated
statement of operations. Although the Supply Term expired on September 30, 2014, we were permitted to sell any AG Products in our inventory or owed to us by
Shire under the Amended and Restated Shire Agreement until all such products are sold. We sold all remaining AG Products in our inventory during the year
ended December 31, 2016. We continued to pay a profit share to Shire on sales of such products during the year ended December 31, 2016 .
Development, Supply and Distribution Agreement with Tolmar, Inc.
In June 2012, we entered into a Development, Supply and Distribution Agreement with Tolmar (the "Tolmar Agreement"). Under the terms of the Tolmar
Agreement, Tolmar granted us an exclusive license to commercialize up to 11 generic topical prescription drug products, including ten currently approved products
in the United States and its territories; the parties agreed in 2015 to terminate development efforts of one product under the Tolmar Agreement that had been
pending approval at the FDA. Under the terms of the Tolmar Agreement, Tolmar is responsible for developing and manufacturing the products, and we are
responsible for marketing and sale of the products. As of December 31, 2016 , we were currently marketing and selling four approved products. We are required to
pay a profit share to Tolmar on sales of each product commercialized pursuant to the terms of the Tolmar Agreement.
We paid Tolmar a $21.0 million upfront payment upon signing of the agreement and, pursuant to the terms of the agreement, are also required to make
payments to Tolmar up to an aggregate amount of $25.0 million upon the achievement of certain specified milestone events. The contingent milestone payments
are initially recognized in the period the triggering event occurs. Milestone payments which are contingent upon commercialization events are accounted for as an
additional cost of acquiring the product license rights. Milestone payments which are contingent upon regulatory approval events are capitalized and amortized
over the remaining estimated useful life of the approved product. As of December 31, 2016, we had paid a total of $20.0 million to Tolmar upon the achievement
of certain specified milestone events, including $12.0 million upon the achievement of a regulatory milestone event and $5.0 million upon the achievement of a
commercialization event and do not currently expect to make any additional milestone payments to Tolmar under the agreement. The $21.0 million upfront
payment for the Tolmar product rights has been allocated to the underlying topical products based upon the relative fair value of each product and will be
amortized over the remaining estimated useful life of each underlying product, ranging from five to 12 years, starting upon commencement of commercialization
activities by us during the second half of 2012. The amortization of the Tolmar product rights has been included as a component of cost of revenues on our
consolidated statement of operations. We are also required to pay a profit share to Tolmar on sales of the topical products, of which we owed a profit share payable
to Tolmar of $36.4 million , $77.7 million and $16.0 million during the years ended December 31, 2016 , 2015 and 2014 , respectively, with a corresponding
charge included in the cost of revenues line in our consolidated statement of operations.
We entered into a Loan and Security Agreement with Tolmar in March 2012 (the “Tolmar Loan Agreement”), under which we agreed to lend to Tolmar
one or more loans through December 31, 2014, in an aggregate amount not to exceed $15.0 million . The outstanding principal amount of, including any accrued
and unpaid interest on, the loans under the Tolmar Loan Agreement are payable by Tolmar beginning from March 31, 2017 through March 31, 2020 or the
maturity date, in accordance with the terms therein. Pursuant to the Tolmar Loan Agreement, Tolmar could prepay all or any portion of the outstanding balance of
the loans prior to the maturity date without penalty or premium. In May 2016, Tolmar repaid in full the $15.0 million due to us under the Tolmar Loan Agreement.
Mebendazole Product Acquisition Agreement with Teva Pharmaceuticals USA, Inc.
In August 2013, we, through our Amedra Pharmaceuticals subsidiary, entered into a product acquisition agreement (the “Mebedanzole Product
Acquisition Agreement”) with Teva Pharmaceuticals USA, Inc. (“Teva”) pursuant to which we acquired the assets (including the ANDA and other regulatory
materials) and related liabilities related to Teva’s mebendazole tablet product in all dosage forms. Pursuant to the Mebendazole Product Acquisition Agreement,
we are required to pay certain milestone payments up to an aggregate amount of $3.5 million upon the approval and launch of the mebendazole tablet product; we
paid the $3.5 million to Teva during the quarter ended March 31, 2016 upon the FDA's approval and our subsequent launch of Emverm® (mebendazole) 100 mg
chewable tablets. We are also obligated to pay Teva a royalty payment based on net sales of Emverm®, including a specified annual minimum royalty payment,
subject to customary reductions and the other terms and conditions set forth in the Mebedanzole Product Acquisition Agreement.
8
Rx Partner and OTC Partner Alliance Agreements
We have entered into alliance agreements with unrelated third-party pharmaceutical companies pursuant to which our partner distributes a specified
product or products which we developed and, in some cases manufacture. Pursuant to these alliance agreements we typically receive payment on delivery of the
product, and share in the resulting profits, or receive a royalty or other payments from our partners. Our alliance agreements are separated into two sales channels,
the “Rx Partner” sales channel, for generic prescription products sold through our partners under their own label, and the “OTC Partner” sales channel, for sales of
generic pharmaceutical OTC products sold through our partner under their own label. The revenue recognized and the percentage of gross revenue for each of the
periods noted, for the Rx Partner and the OTC Partner alliance agreements, was as follows:
2016
2015
2014
Year Ended December 31,
(in thousands)
Gross Revenue and % Gross Revenue
Rx Partner
OTC Partner
* Not material
Strategic Alliance Agreement with Teva
$
$
14,339
225
1% $
*
$
9,307
1,744
1% $
1% $
14,114
1,319
1%
1%
We are a party to a Strategic Alliance Agreement dated as of June 27, 2001 with Teva Pharmaceutical USA, Inc. ("Teva USA"), an affiliate of Teva,
which was subsequently amended (“Teva Agreement”). The Teva Agreement commits us to develop and manufacture, and Teva to distribute, a specified number
of controlled release generic pharmaceutical products (“generic products”), each for a 10-year period. As of December 31, 2016 , we were supplying Teva with
oxybutynin extended release tablets (Ditropan XL® 5 mg, 10 mg and 15 mg extended release tablets); the other products under the Teva Agreement have either
been returned to us, are being manufactured by Teva at its election, were voluntarily withdrawn from the market or our obligations to supply such product had
expired or were terminated in accordance with the Teva Agreement.
For more information about the Teva Agreement, see “Item 15. Exhibits and Financial Statement Schedules – Note 20. Alliance and Collaboration
Agreements.”
OTC Partner Alliance Agreements
In June 2002, we entered into a Development, License and Supply Agreement with Pfizer, Inc., formerly Wyeth LLC (“Pfizer”), for a term of 15 years,
relating to our Loratadine and Pseudoephedrine Sulfate 5 mg/120 mg 12-hour Extended Release Tablets (the "D12 Product") and Loratadine and Pseudoephedrine
Sulfate 10 mg/240 mg 24-hour Extended Release Tablets for the OTC market (the "D24 Product"); the agreement was terminated with respect to the D24 Product
in 2005. We previously developed the products and are currently only responsible for manufacturing the products. Pfizer is responsible for marketing and sale of
the products. The agreement included payments to us upon achievement of development milestones, as well as royalties paid to us by Pfizer on its sales of the
product. Pfizer launched this product in May 2003 as Alavert® D-12 Hour. In December 2011, we and Pfizer entered into an agreement with L. Perrigo Company
(“Perrigo”), which was subsequently amended whereby the parties agreed that we would supply our D-12 Product to Perrigo in the United States and its territories.
The agreements with Pfizer and Perrigo are no longer a core area of our business, and the over-the-counter pharmaceutical products we sell to Pfizer and Perrigo
under the agreements are older products which are only sold to Pfizer and Perrigo. We recognize profit share revenue in the period earned.
During the quarter ended September 30, 2016, we sold the ANDAs for both the D12 Product and the D24 Product, in addition to other specified assets, to
Perrigo pursuant to an asset purchase agreement with Perrigo dated as of March 31, 2016 (the "Perrigo APA"). Under the terms of the Perrigo APA, we will also
continue to supply the D-12 Product to Pfizer and Perrigo until the date that is the earliest of (i) the date Perrigo’s manufacturing facility is approved to
manufacture the D-12 Product and (ii) December 31, 2017 (the "Supply End Date"). On the Supply End Date, we will assign and transfer our supply agreement
with Pfizer in its entirety to Perrigo in accordance with the Perrigo APA.
9
Agreements with Valeant Pharmaceuticals International, Inc.
In November 2008, we entered into a Joint Development Agreement and a License and Settlement Agreement ("Joint Development Agreement") with
Valeant Pharmaceuticals International, Inc., formerly Medicis Pharmaceutical Corporation (“Valeant”), providing for collaboration in the development of a total of
five dermatology products, including four of our generic products and one branded advanced form of Valeant’s Solodyn® product. We have the potential to
receive up to an additional $8.0 million of contingent milestone payments each of which we believe to be substantive, as well as the potential to receive royalty
payments from sales, if any, by Valeant of its advanced form Solodyn® brand product. Finally, to the extent we commercialize any of the four generic dermatology
products covered by the Joint Development Agreement, we will pay to Valeant a gross profit share on sales of such products. We began selling one of the four
generic dermatology products during the year ended December 31, 2011 and began selling a second dermatology product during the quarter ended September 30,
2016.
For more information about the Joint Development Agreement with Valeant, see “Item 15. Exhibits and Financial Statement Schedules – Note 20.
Alliance and Collaboration Agreements.”
Impax Specialty Pharma – Alliance and Collaboration Agreements
Distribution, License, Development and Supply Agreement with AstraZeneca UK Limited
In January 2012, we entered into the AZ Agreement with AstraZeneca and the parties subsequently entered into a First Amendment to the AZ Agreement
dated May 31, 2016 (as amended, the "AZ Amendment"). Under the terms of the AZ Agreement, AstraZeneca granted us an exclusive license to commercialize the
tablet, orally disintegrating tablet and nasal spray formulations of Zomig® (zolmitriptan) products for the treatment of migraine headaches in the United States and
in certain U.S. territories, except during an initial transition period when AstraZeneca fulfilled all orders of Zomig® products on our behalf and AstraZeneca paid
us the gross profit on such Zomig® product sales. We are obligated to fulfill certain minimum requirements with respect to the promotion of currently approved
Zomig® products as well as other dosage strengths of such products approved by the FDA in the future. We may, but have no obligation to, develop and
commercialize additional products containing zolmitriptan and additional indications for Zomig®, subject to certain restrictions as set forth in the AZ Agreement.
Subject to the terms of the AZ Agreement, we will be responsible for conducting clinical studies and preparing regulatory filings related to the development of any
such additional products and would bear all related costs. During the term of the AZ Agreement, AstraZeneca will continue to be the holder of the NDA for
existing Zomig® products, as well as any future dosage strengths thereof approved by the FDA, and will be responsible for certain regulatory and quality-related
activities for such Zomig® products. AstraZeneca will manufacture and supply Zomig® products to us and we will purchase our requirements of Zomig® products
from AstraZeneca until a date determined in the AZ Agreement. Thereafter, AstraZeneca may terminate its supply obligations upon certain advance notice to us, in
which case we would have the right to manufacture or have manufactured our own requirements for the applicable Zomig® product. Under the terms of the AZ
Amendment, under certain conditions and depending on the nature and terms of the study agreed to with the FDA, we agreed to conduct, at our own expense, the
juvenile toxicity study and pediatric study required by the FDA under the Pediatric Research Equity Act (“PREA”) for approval of the nasal formulation of Zomig
® for the acute treatment of migraine in pediatric patients ages six through eleven years old, as further described in the study protocol mutually agreed to by the
parties (the “PREA Study”). In consideration for us conducting the PREA Study at our own expense, the AZ Amendment provides for the total royalty payments
payable by us to AstraZeneca on net sales of Zomig ® products under the AZ Agreement to be reduced by certain specified amounts beginning from the quarter
ended June 30, 2016 and through the quarter ended December 31, 2020, with such reduced royalty amounts totaling an aggregate amount of $30.0 million . In the
event the royalty reduction amounts exceed the royalty payments payable by us to AstraZeneca pursuant to the AZ Agreement in any given quarter, AstraZeneca
will be required to pay us an amount equal to the difference between the royalty reduction amount and the royalty payment payable by us to AstraZeneca. Our
commitment to perform the PREA Study may be terminated, without penalty, under certain circumstances as set forth in the AZ Amendment.
10
Under the terms of the AZ Agreement, AstraZeneca was required to make payments to us representing 100% of the gross profit on sales of AstraZeneca-
labeled Zomig® products during the specified transition period. Beginning from January 2013, we have paid AstraZeneca tiered royalties on net sales of branded
Zomig® products, depending on brand exclusivity and subject to customary reductions and other terms and conditions set forth in the AZ Agreement. We also paid
AstraZeneca royalties based on gross profit from sales of authorized generic versions of the Zomig® products subject to certain terms and conditions set forth in
the AZ Agreement. In May 2013, our exclusivity period for branded Zomig® tablets and orally disintegrating tablets expired and we launched authorized generic
versions of those products in the United States. As discussed above, pursuant to the AZ Amendment, the total royalty payments payable by us to AstraZeneca on
net sales of Zomig ® products under the AZ Agreement is reduced by certain specified amounts beginning from the quarter ended June 30, 2016 and through the
quarter ended December 31, 2020, with such reduced royalty amounts totaling an aggregate amount of $30.0 million . We owed a royalty payable to AstraZeneca
of $17.2 million , $16.8 million and $14.3 million for the years ended December 31, 2016 , 2015 and 2014 , respectively, with a corresponding charge included in
the cost of revenues line on our consolidated statements of operations.
Agreement with DURECT Corporation
During the three month period ended March 31, 2014, we entered into an agreement with DURECT Corporation (“Durect”) granting us the exclusive
worldwide rights to develop and commercialize DURECT’s investigational transdermal bupivacaine patch for the treatment of pain associated with post-herpetic
neuralgia, which we refer to as IPX239. We paid Durect a $2.0 million up-front payment upon signing of the agreement which we recognized immediately as
research and development expense. We have the potential to pay up to an aggregate of $61.0 million in additional contingent milestone payments upon the
achievement of certain specified development and commercialization events under the agreement. If IPX239 is commercialized, we would also be required to pay a
tiered royalty based on product sales.
Our Controlled-Release Technology
We have developed a number of different controlled-release delivery technologies which may be utilized with a variety of oral dosage forms and drugs.
Controlled-release drug delivery technologies are designed to release drug dosages at specific times and in specific locations in the body and generally provide
more consistent and appropriate drug levels in the bloodstream than immediate-release dosage forms. Controlled-release pharmaceuticals may improve drug
efficacy, ensure greater patient compliance with the treatment regimen, reduce side effects or increase drug stability and be more patient friendly by reducing the
number of times a drug must be taken.
We believe our controlled-release drug delivery technologies are flexible and can be applied to develop a variety of pharmaceutical products, both generic
and branded. Our technologies utilize a variety of polymers and other materials to encapsulate or entrap the active pharmaceutical ingredients and to release them
at varying rates or at predetermined locations in the gastrointestinal tract.
Competition
The pharmaceutical industry is highly competitive and is affected by new technologies, new developments, government regulations, health care
legislation, availability of financing, and other factors. Many of our competitors have longer operating histories and substantially greater financial, research and
development, marketing, and other resources than we have. We compete with numerous other companies that currently operate, or intend to operate, in the
pharmaceutical industry, including companies that are engaged in the development of controlled-release drug delivery technologies and products, and other
manufacturers that may decide to undertake development of such products. Our principal competitors in the generic pharmaceutical products market are Teva
Pharmaceutical Industries Ltd., Mylan N.V., Sun Pharmaceutical Industries Ltd., Lannett Company, Inc., Lupin Pharmaceuticals, Inc., Endo International plc and
Sandoz.
Due to our focus on relatively hard to replicate controlled-release products, competition in the generic pharmaceutical market is sometimes limited to
those competitors who possess the appropriate drug delivery technology. The principal competitive factors in the generic pharmaceutical market are:
•
•
•
•
•
the ability to introduce generic versions of products promptly after a patent expires;
price;
product quality;
customer service (including maintenance of inventories for timely delivery); and
the ability to identify and market niche products.
11
In the brand-name pharmaceutical market, our principal competitors are pharmaceutical companies that are focused on Parkinson’s disease and other CNS
disorders. In addition, with respect to products that we are developing internally and/or any additional products we may in-license from third parties, we expect that
we will face increased competition from large pharmaceutical companies, drug delivery companies and other specialty pharmaceutical companies that have
focused on the same disorders as our branded products.
A description of the competition we face from brand-name and generic pharmaceutical companies is included in “Item 1A. Risk Factors.”
Sales and Marketing
We market and sell our generic pharmaceutical prescription drug products within the continental United States and the Commonwealth of Puerto Rico.
We have not made sales in any other jurisdictions over the last three fiscal years. We derive a substantial portion of our revenue from sales to a limited number of
customers. The customer base for our products consists primarily of drug wholesalers, warehousing chain drug stores, mass merchandisers, and mail-order
pharmacies. We market our products both directly, through our Impax Generics and Impax Specialty Pharma divisions, and indirectly through our Rx Partner and
OTC Partner alliance and collaboration agreements. Together, our five major customers, McKesson Corporation, Cardinal Health, Amerisource-Bergen, N.C.
Mutual and CVS Caremark Corporation, accounted for 90% of our gross revenue for the year ended December 31, 2016 . These five customers individually
accounted for 40%, 28%, 20%, 1% and 1%, respectively, of our total gross revenue for the year ended December 31, 2016 . We do not have long-term contracts in
effect with our five major customers. A reduction in or loss of business with any one of these customers, or any failure of a customer to pay us on a timely basis,
would adversely affect our business.
Manufacturing and Distribution
We source our finished dosage form products from our own facilities in Hayward, California; Middlesex, New Jersey; and Taiwan. We also use several
contract manufacturers for this purpose. During 2015, we restructured our packaging and distribution operations. As a result, we closed our Philadelphia packaging
site and all of our company-wide distribution operations were outsourced to United Parcel Services (UPS). During 2016, the Board of Directors approved a plan to
close the Middlesex, New Jersey manufacturing and packaging site, which was then amended to repurpose a part of the Middlesex manufacturing site as a research
and development pilot plant.
We maintain an inventory of our products in connection with our obligations under our alliance and collaboration agreements. In addition, for products
pending approval, we may produce batches for inventory in anticipation of the launch of the products. In the event that FDA approval is denied or delayed, we
could be exposed to the risk of this inventory becoming obsolete.
Raw Materials
The raw materials we use in the production of our products consist of pharmaceutical chemicals in various forms that are generally available from several
sources in the United States and throughout the world. In some cases, however, the raw materials, such as the active pharmaceutical ingredients (“API”) used to
manufacture our products, are available only from a single supplier. Further, even if more than one supplier exists, we may choose, and have done so in the case of
our API suppliers for a majority of our products, to list only one supplier in our product applications submitted to the FDA. The FDA requires identification of raw
material suppliers in applications for approval of drug products. If raw materials were unavailable from a specified supplier or the supplier was not in compliance
with FDA or other applicable requirements, the FDA approval of a new supplier could delay the manufacture of the drug involved. As a result, there is no
guarantee we will always have timely and sufficient access to a required raw material or other product. Generally, we would need as long as 18 months to find and
qualify a new sole-source supplier. If we receive less than one year’s termination notice from a sole-source supplier that it intends to cease supplying raw materials,
it could result in disruption of our ability to produce the drug involved. We currently do not have long-term supply agreements with the majority of our API
suppliers and although to date we have only experienced occasional interruptions in supplies, no assurance can be given that we will continue to receive
uninterrupted or adequate supplies of such raw materials. Any inability to obtain raw materials on a timely basis, or any significant price increases not passed on to
customers, could have a material adverse effect on us.
12
Quality Control
Regulatory agencies such as the FDA regularly inspect our manufacturing facilities and the facilities of our third party suppliers. The failure of one of our
facilities, or a facility of one of our third party suppliers, to comply with applicable laws and regulations may lead to breach of representations made to our
customers or to regulatory or government action against us related to products made in that facility. We have in the past received a warning letter from the FDA
regarding certain operations within our manufacturing network at our Hayward manufacturing facility, which we subsequently resolved in 2015. We remain
committed to continuing to improve our quality control and manufacturing practices, however, we cannot be assured that the FDA will continue to be satisfied with
our corrective actions and with our quality control and manufacturing systems and standards. Failure to comply strictly with these regulations and requirements
may damage our reputation and lead to financial penalties, compliance expenditures, the recall or seizure of products, total or partial suspension of production
and/or distribution, withdrawal or suspension of the applicable regulator’s review of our submissions, enforcement actions, injunctions and criminal prosecution.
Further, other federal agencies, our customers and partners in our alliance, development, collaboration and other partnership agreements with respect to our
products and services may take any such FDA observations or warning letters into account when considering the award of contracts or the continuation or
extension of such partnership agreements. Because regulatory approval to manufacture a drug is site-specific, the delay and cost of remedial actions, or obtaining
approval to manufacture at a different facility, could negatively impact our business. Any failure by us to comply with applicable laws and regulations and/or any
actions by the FDA and other agencies as described above could have a material adverse effect on our business, financial position and results of operations
Research and Development
We conduct most of our research and development activities at our facilities in Hayward, California and Middlesex, NJ, with a staff of 182 employees as
of December 31, 2016 . In addition, we have outsourced a number of research and development projects to third-party laboratories.
We spent approximately $80.5 million, $70.6 million and $78.6 million on research and development activities during the years ended December 31,
2016 , 2015 and 2014 , respectively, as more fully set out in the tables below (in millions).
Year Ended December 31, 2016
Clinical study expenses
Personnel expenses
Experimental materials
Outside services
Facility expenses
Legal expenses
Other
Total
Year Ended December 31, 2015
Clinical study expenses
Personnel expenses
Experimental materials
Outside services
Facility expenses
Legal expenses
Other
Total
Impax
Generics
Impax Specialty
Pharma
Total
Impax
11.1 $
25.0
6.1
7.1
3.7
0.1
9.1
2.4 $
10.8
—
3.3
0.5
0.2
1.1
62.2 $
18.3 $
Impax
Generics
Impax
Specialty
Pharma
Total
Impax
4.6 $
28.6
4.3
5.8
4.2
0.4
4.6
0.8 $
10.0
—
4.5
0.4
0.2
2.2
52.5 $
18.1 $
13.5
35.8
6.1
10.4
4.2
0.3
10.2
80.5
5.4
38.6
4.3
10.3
4.6
0.6
6.8
70.6
$
$
$
$
13
Year Ended December 31, 2014
Clinical study expenses
Personnel expenses
Experimental materials
Outside services
Facility expenses
Legal expenses
Other
Total
division.
Impax
Generics
Impax
Specialty
Pharma
Total
Impax
10.2 $
17.1
5.0
2.7
2.7
0.3
2.9
7.6 $
17.7
0.7
4.9
1.1
0.5
5.2
40.9 $
37.7 $
17.8
34.8
5.7
7.6
3.8
0.8
8.1
78.6
$
$
We do not generally track research and development expense by individual product in either the Impax Generics division or the Impax Specialty Pharma
In the Impax Generics division, we focus our research and development efforts based on drug-delivery technology and on products that we believe may
have certain competitive advantages, rather than on any particular therapeutic area. As of December 31, 2016 , the Impax Generics division had 25 product
applications pending with the FDA and another 26 products in development. Accordingly, we believe that our generic pipeline products will, in the aggregate,
generate a significant amount of revenue for us in the future. However, while a generic product is still in development, we are unable to predict the level of
commercial success that the product may ultimately achieve given the uncertainties relating to the successful and timely completion of bioequivalence studies,
ANDA filing, receipt of marketing approval and resolution of any related patent litigation, as well as the amount of competition in the market at the time of product
launch and thereafter and other factors detailed in “Item 1A. Risk Factors.” Additionally, we do not believe that any individual generic pipeline product is currently
significant in terms of accrued or anticipated research and development expense given the large volume of products under development in the Impax Generics
division, as detailed above. Further, on a per product basis, development costs for generic products tend to be significantly lower than for branded products, as the
process for establishing bioequivalence is significantly less extensive than the standard clinical trial process. The regulatory approval process is significantly less
onerous as well compared to the process for branded products.
In the Impax Specialty Pharma division, we currently market one internally developed branded pharmaceutical product, Rytary® (IPX066) for the
treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication,
which was approved by the FDA on January 7, 2015 and which we launched in the United States in April 2015. In addition to Rytary®, Impax Specialty Pharma is
also currently engaged in the sale and distribution of four other branded products; the more significant include Zomig® (zolmitriptan) products, indicated for the
treatment of migraine headaches, under the terms the AZ Agreement, and Emverm® (mebendazole) 100 mg chewable tablets, indicated for the treatment of
pinworm, whipworm, common roundworm, common hookworm, and American hookworm in single or mixed infection. We also have a number of product
candidates that are in varying stages of development. While we believe the pipeline products in this division are potentially viable, profitable product candidates
for us, given the uncertainties relating to the successful completion of clinical trials, the FDA approval process for branded products, reimbursement levels, the
amount of competition at the time of product launch and thereafter and other factors detailed in “Item 1A. Risk Factors,” such pipeline products are too early in the
development process to be considered significant at this point in time.
Regulation
The manufacturing and distribution of pharmaceutical products are subject to extensive regulation by the federal government, primarily through the FDA
and the Drug Enforcement Administration (“DEA”), and to a lesser extent by state and local governments. The Food, Drug, and Cosmetic Act, Controlled
Substances Act and other federal statutes and regulations govern or influence the manufacture, labeling, testing, storage, record keeping, approval, advertising and
promotion of our products. As described above under "Quality Control", facilities used in the manufacture, packaging, labeling and repackaging of pharmaceutical
products must be registered with the FDA and are subject to FDA inspection to ensure that drug products are manufactured in accordance with current Good
Manufacturing Practices. Noncompliance with applicable requirements can result in product recalls, seizure of products, injunctions, suspension of production
and/or distribution, refusal of the government or third parties to enter into contracts with us, withdrawal or suspension of the applicable regulator's review of our
drug applications, civil penalties and criminal fines, and disgorgement of profits.
14
FDA approval is required before any “new drug” may be marketed, including new formulations, strengths, dosage forms and generic versions of
previously approved drugs. Generally, the following two types of applications are used to obtain FDA approval of a “new drug.”
New Drug Application (“NDA”). For a drug product containing an active ingredient not previously approved by the FDA, a prospective manufacturer
must submit a complete application containing the results of clinical studies supporting the drug product’s safety and efficacy. A NDA is also required for a drug
with a previously approved active ingredient if the drug will be used to treat an indication for which the drug was not previously approved or if the dosage form,
strength or method of delivery is changed. The process required by the FDA before a pharmaceutical product may be approved for marketing in the U.S. generally
involves the steps listed below, which could take from approximately three to more than ten years to complete.
•
•
•
•
•
•
Laboratory and clinical tests;
Submission of an Investigational New Drug (“IND”) application, which must become effective before clinical studies may begin;
Adequate and well-controlled human clinical studies to establish the safety and efficacy of the proposed product for its intended use;
Submission of a NDA containing the results of the preclinical tests and clinical studies establishing the safety and efficacy of the proposed product
for its intended use, as well as extensive data addressing such matters such as manufacturing and quality assurance;
Scale-up to commercial manufacturing; and
FDA approval of a NDA.
As noted above, the submission of a NDA is not a guarantee that the FDA will find it complete and accept it for filing. The FDA reviews all NDAs
submitted before it accepts them for filing. It may refuse to file the application and instead request additional information, in which case, the application must be
resubmitted with the supplemental information. After the application is deemed filed by the FDA, FDA staff will review a NDA to determine, among other things,
whether a product is safe and efficacious for its intended use.
If, after reviewing the NDA, the FDA determines that the application cannot be approved in its current form, the FDA sends the NDA applicant a
Complete Response Letter identifying all outstanding deficiencies that preclude final approval. The FDA then halts its review until the applicant resubmits the
NDA with new information designed to address the deficiencies. An applicant receiving a Complete Response Letter may resubmit the application with data and
information addressing the FDA’s concerns or requirements, withdraw the application without prejudice to a subsequent submission of a related application or
request a hearing on whether there are grounds for denying approval of the application. If a product receives regulatory approval, the approval may be significantly
limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. In addition,
the FDA may require an applicant to conduct Phase 4 testing which involves clinical trials designed to further assess a drug’s safety and effectiveness after NDA
approval, and may require surveillance programs to monitor the safety of approved products which have been commercialized. Once issued, the FDA may
withdraw product approval if ongoing regulatory requirements are not met or if safety or efficacy questions are raised after the product reaches the market. The
agency may also impose requirements that the NDA holder conduct new studies, make labeling changes, implement Risk Evaluation and Mitigation Strategies, and
take other corrective measures.
Abbreviated New Drug Application (“ANDA”). For a generic version of an approved drug — a drug product that contains the same active ingredient as a
drug previously approved by the FDA and is in the same dosage form and strength, utilizes the same method of delivery and will be used to treat the same
indications as the approved product — the FDA requires only an abbreviated new drug application that ordinarily need not include clinical studies demonstrating
safety and efficacy. An ANDA typically requires only data demonstrating that the generic formulation is bioequivalent to the previously approved “reference listed
drug,” indicating that the rate of absorption and levels of concentration of the generic drug in the body do not show a significant difference from those of the
reference listed drug. In July 2012, the Generic Drug Fee User Amendments of 2012 (“GDUFA”) was enacted into law. The GDUFA legislation implemented fees
for new ANDA applications, Drug Master Files, product and establishment fees and a one-time fee for back-logged ANDA applications pending approval as of
October 1, 2012. In return, the program was intended to provide faster and more predictable ANDA reviews by the FDA and increased inspections of drug
facilities. Under GDUFA, generic product companies face significant penalties for failure to pay the new user fees, including rendering an ANDA application not
“substantially complete” until the fee is paid. Prior to the implementation of GDUFA, the FDA took an average of approximately 30 months to approve an ANDA.
Following the implementation of GDUFA, the FDA’s stated internal goal for ANDAs submitted in fiscal year 2016 was to have a “first-action” goal date within 15
months of submission on 75% of submitted ANDAs. The “first-action” goal date is referred to by the FDA as the date in which the FDA takes a first action on an
application by either granting approval or tentative approval or in the event of deficiencies, identifying those deficiencies in a complete response letter or in a
refusal to receive the application.
15
Under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the “Hatch-Waxman Act,” which established the
procedures for obtaining approval of generic drugs, an ANDA filer must make certain patent certifications that can result in significant delays in obtaining FDA
approval. If the applicant intends to challenge the validity or enforceability of an existing patent covering the reference listed drug or asserts that its drug does not
infringe such patent, the applicant files a so called “Paragraph IV” certification and notifies the patent holder that it has done so, explaining the basis for its belief
that the patent is not infringed or is invalid or unenforceable. If the patent holder initiates a patent infringement suit within 45 days after receipt of the Paragraph IV
Certification, the FDA is automatically prevented from approving an ANDA until the earlier of 30 months after the date the Paragraph IV Certification is given to
the patent holder, expiration of the patents involved in the certification, or when the infringement case is decided in the ANDA applicant’s favor. In addition, the
first company to file an ANDA for a given drug containing a Paragraph IV certification can be awarded 180 days of market exclusivity following approval of its
ANDA, during which the FDA may not approve any other ANDAs for that drug product.
During any period in which the FDA is required to withhold its approval of an ANDA due to a statutorily imposed non-approval period, the FDA may
grant tentative approval to an applicant’s ANDA. A tentative approval reflects the FDA’s preliminary determination that a generic product satisfies the substantive
requirements for approval, subject to the expiration of all statutorily imposed non-approval periods. A tentative approval does not allow the applicant to market the
generic drug product.
The Hatch-Waxman Act contains additional provisions that can delay the launch of generic products. A five year marketing exclusivity period is provided
for new chemical compounds, and a three year marketing exclusivity period is provided for approved applications containing new clinical investigations essential
to an approval, such as a new indication for use, or new delivery technologies, or new dosage forms. The three year marketing exclusivity period applies to, among
other things, the development of a novel drug delivery system, as well as a new use. In addition, companies can obtain six additional months of exclusivity if they
perform pediatric studies of a reference listed drug product. The marketing exclusivity provisions apply to both patented and non-patented drug products. The Act
also provides for patent term extensions to compensate for patent protection lost due to time taken in conducting FDA required clinical studies and during FDA
review of NDAs.
The Generic Drug Enforcement Act of 1992 establishes penalties for wrongdoing in connection with the development or submission of an ANDA. In
general, the FDA is authorized to temporarily bar companies, or temporarily or permanently bar individuals, from submitting or assisting in the submission of an
ANDA, and to temporarily deny approval and suspend applications to market generic drugs under certain circumstances. In addition to debarment, the FDA has
numerous discretionary disciplinary powers, including the authority to withdraw approval of an ANDA or to approve an ANDA under certain circumstances and to
suspend the distribution of all drugs approved or developed in connection with certain wrongful conduct. The FDA may also withdraw product approval or take
other correct measures if ongoing regulatory requirements are not met or if safety or efficacy questions are raised after the product reaches the market.
Other Regulatory Requirements
We are subject to the Maximum Allowable Cost Regulations, which limit reimbursements for certain generic prescription drugs under Medicare,
Medicaid, and other programs to the lowest price at which these drugs are generally available. In many instances, only generic prescription drugs fall within the
regulations’ limits. Generally, the pricing and promotion of, method of reimbursement and fixing of reimbursement levels for, and the reporting to federal and state
agencies relating to drug products is under active review by federal, state and local governmental entities, as well as by private third-party reimbursers and
individuals under whistleblower statutes. At present, the Justice Department and U.S. Attorneys Offices and State Attorneys General have initiated investigations,
reviews, and litigation into industry-wide pharmaceutical pricing and promotional practices, and whistleblowers have filed qui tam suits. We cannot predict the
results of those reviews, investigations, and litigation, or their impact on our business.
Virtually every state, as well as the District of Columbia, has enacted legislation permitting the substitution of equivalent generic prescription drugs for
brand-name drugs where authorized or not prohibited by the prescribing physician, and some states mandate generic substitution in Medicaid programs.
In addition, numerous state and federal requirements exist for a variety of controlled substances, such as narcotics, that may be part of our product
formulations. The DEA, which has authority similar to the FDA’s and may also pursue monetary penalties, and other federal and state regulatory agencies have far
reaching authority.
16
The State of California requires that any manufacturer, wholesaler, retailer or other entity in California that sells, transfers, or otherwise furnishes certain
so called precursor substances must have a permit issued by the California Department of Justice, Bureau of Narcotic Enforcement. The substances covered by this
requirement include ephedrine, pseudoephedrine, norpseudoephedrine, and phenylpropanolamine, among others. The Bureau has authority to issue, suspend and
revoke precursor permits, and a permit may be denied, revoked or suspended for various reasons, including (i) failure to maintain effective controls against
diversion of precursors to unauthorized persons or entities; (ii) failure to comply with the Health and Safety Code provisions relating to precursor substances, or
any regulations adopted thereunder; (iii) commission of any act which would demonstrate actual or potential unfitness to hold a permit in light of the public safety
and welfare, which act is substantially related to the qualifications, functions or duties of the permit holder; or (iv) if any individual owner, manager, agent,
representative or employee of the permit applicant/permit holder willfully violates any federal, state or local criminal statute, rule, or ordinance relating to the
manufacture, maintenance, disposal, sale, transfer or furnishing of any precursor substances.
Patents, Trademarks and Licenses
We own or license a number of patents in the U.S. and other countries covering certain products and product candidates and have also developed brand
names and trademarks for other products and product candidates. Generally, the brand pharmaceutical business relies upon patent protection to ensure market
exclusivity for the life of the patent. We consider the overall protection of our patents, trademarks and license rights to be of material value and act to protect these
rights from infringement. However, our business is not dependent upon any single patent, trademark or license.
In the branded pharmaceutical industry, the majority of an innovative product’s commercial value is usually realized during the period in which the
product has market exclusivity. In the U.S. and some other countries, when market exclusivity expires and generic versions of a product are approved and
marketed, there can often be very substantial and rapid declines in the branded product’s sales. The rate of this decline varies by country and by therapeutic
category; however, following patent expiration, branded products often continue to have market viability based upon the goodwill of the product name, which
typically benefits from trademark protection.
An innovator product’s market exclusivity is generally determined by two forms of intellectual property: patent rights held by the innovator company and
any regulatory forms of exclusivity to which the innovator is entitled.
Patents are a key determinant of market exclusivity for most branded pharmaceuticals. Patents provide the innovator with the right to exclude others from
practicing an invention related to the medicine. Patents may cover, among other things, the active ingredient(s), various uses of a drug product, pharmaceutical
formulations, drug delivery mechanisms and processes for (or intermediates useful in) the manufacture of products. Protection for individual products extends for
varying periods in accordance with the expiration dates of patents in the various countries. The protection afforded, which may also vary from country to country,
depends upon the type of patent, its scope of coverage and the availability of meaningful legal remedies in the country.
Market exclusivity is also sometimes influenced by regulatory exclusivity rights. Many developed countries provide certain non-patent incentives for the
development of medicines. For example, the U.S., the EU and Japan each provide for a minimum period of time after the approval of a new drug during which the
regulatory agency may not rely upon the innovator’s data to approve a competitor’s generic copy. Regulatory exclusivity rights are also available in certain markets
as incentives for research on new indications, on orphan drugs and on medicines useful in treating pediatric patients. Regulatory exclusivity rights are independent
of any patent rights and can be particularly important when a drug lacks broad patent protection. However, most regulatory forms of exclusivity do not prevent a
competitor from gaining regulatory approval prior to the expiration of regulatory data exclusivity on the basis of the competitor’s own safety and efficacy data on
its drug, even when that drug is identical to that marketed by the innovator.
We estimate the likely market exclusivity period for each of our branded products on a case-by-case basis. It is not possible to predict the length of market
exclusivity for any of our branded products with certainty because of the complex interaction between patent and regulatory forms of exclusivity, and inherent
uncertainties concerning patent litigation. There can be no assurance that a particular product will enjoy market exclusivity for the full period of time that we
currently estimate or that the exclusivity will be limited to the estimate.
In addition to patents and regulatory forms of exclusivity, we also market products with trademarks. Trademarks have no effect on market exclusivity for
a product, but are considered to have marketing value. Trademark protection continues in some countries as long as used; in other countries, as long as registered.
Registration is for fixed terms and may be renewed indefinitely.
17
Environmental Laws
We are subject to comprehensive federal, state and local environmental laws and regulations that govern, among other things, air polluting emissions,
waste water discharges, solid and hazardous waste disposal, and the remediation of contamination associated with current or past generation handling and disposal
activities. We are subject periodically to environmental compliance reviews by various environmental regulatory agencies. While it is impossible to predict
accurately the future costs associated with environmental compliance and potential remediation activities, compliance with environmental laws is not expected to
require significant capital expenditures and has not had, and is not expected to have, a material adverse effect on our business, operations or financial condition.
Available Information
We maintain an Internet website at the following address: www.impaxlabs.com. We make available on or through our Internet website certain reports and
amendments to those reports, as applicable, that we file with or furnish to the Securities and Exchange Commission (the “SEC”) in accordance with the Securities
Exchange Act of 1934, as amended (the “Exchange Act”). These include our Annual Report on Form 10-K, our Quarterly Reports on Form 10-Q and our Current
Reports on Form 8-K. Our website also includes our Code of Conduct and the charters of our Audit Committee, Nominating Committee, Compensation Committee
and Compliance Committee of our Board of Directors. We make this information available on our website free of charge, as soon as reasonably practicable after
we electronically file the information with, or furnish it to, the SEC. The contents of our website are not incorporated by reference in this Annual Report on Form
10-K and shall not be deemed “filed” under the Exchange Act.
Corporate and Other Information
We were incorporated in the State of Delaware in 1995. Our corporate headquarters are located at 30831 Huntwood Avenue, Hayward, California, 94544.
We were formerly known as Global Pharmaceutical Corporation until December 14, 1999, when Impax Pharmaceuticals, Inc., a privately held drug delivery
company, merged into Global Pharmaceutical Corporation and the name of the resulting entity was changed to Impax Laboratories, Inc.
Unless otherwise indicated, all product sales data and U.S. market size data in this Annual Report on Form 10-K are based on information obtained from
IMS Health, unrelated third-party providers of prescription market data. We did not independently engage IMS Health to provide this information.
Employees
As of December 31, 2016 , we had 1,495 full-time employees, of which 578 were in operations, 182 in research and development, 344 in the quality area,
211 in legal and administration, and 180 in sales and marketing. None of our employees are subject to collective bargaining agreements with labor unions, and we
believe our employee relations are good.
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Item 1A. Risk Factors
An investment in our common stock involves a high degree of risk. In deciding whether to invest in our common stock, you should consider carefully the
following risk factors, as well as the other information included in this Annual Report on Form 10-K. The materialization of any of these risks could have a
material adverse effect on our business, results of operations and financial condition. This Annual Report on Form 10-K contains forward looking statements that
involve risks and uncertainties. Our actual results could differ materially from the results discussed in the forward looking statements. Factors that could cause or
contribute to these differences include those discussed in this “Risk Factors” section. See “Forward-Looking Statements” on page 1 of this Annual Report on Form
10-K.
Risks Related to Our Business
Our operating results and financial condition could fluctuate significantly.
Our operating results and financial condition may vary significantly from year to year and quarter to quarter as well as in comparison to the corresponding
year or quarter of the preceding year, as the case may be, for a number of reasons, including all the risks described in this section. We also cannot predict with any
certainty the timing or level of sales of our products in the future. For instance, we previously earned significant revenues in our Generics Division from sales of
diclofenac sodium gel (generic Solaraze®) during the fourth quarter of 2015 and the first quarter of 2016 as we were the sole generic product on the market. As
competitors entered (or reentered the market), we were unable to maintain our market share and the selling price of the product and the volume of sales and the
pricing of our diclofenac sodium gel declined significantly, to a net sales decline of over 90% by the fourth quarter of 2016 compared to net sales during the fourth
quarter of 2015. The reduced sales of diclofenac sodium gel as a result of increased competition contributed to lower revenues in our Generics Division during the
third and fourth quarters of 2016, compared to the prior year periods. Any diminution of sales revenue and/or gross profit from our significant generic and branded
products due to existing or new competition, product supply or any other reasons in the future may materially and adversely affect our business, results of
operations and financial condition in such periods.
Due to the fluctuations in our operating results and financial condition, we believe that period-to-period comparisons of our operating results are not
necessarily meaningful and should not be relied upon as indications of our future performance and any full-year financial forecast should not be relied upon as a
guarantee of future performance for that year or for any given quarter within that year. If our operating results fall below the expectations of investors or securities
analysts, the value of our securities could decline substantially and our business, results of operations and financial condition could be materially and adversely
affected, as further described below under the risk factor, “ The market price of our common stock has been volatile and may continue to be volatile in the future,
and the value of any investment in our common stock could decline significantly. ”
The market price of our common stock has been volatile and may continue to be volatile in the future, and the value of any investment in our common stock
could decline significantly.
The market price for our shares of common stock listed on the Nasdaq Stock Market has fluctuated significantly from time to time, for example, varying
between a high of $43.16 on January 8, 2016 to a low of $12.28 on December 7, 2016 during the year ended December 31, 2016. The market price of our common
stock is likely to continue to be volatile and subject to significant price and volume fluctuations in response to market, industry and other factors, including the
risks described in this section. Further, the stock market for pharmaceutical companies has recently experienced extreme price and volume fluctuations that have
often been unrelated or disproportionate to the operating performance of those companies. In particular, recent negative publicity regarding pricing and price
increases by pharmaceutical companies has negatively impacted, and may continue to negatively impact, the market for pharmaceutical companies. These broad
market and industry factors have negatively impacted, and in the future may seriously negatively impact, the market price of our common stock, regardless of our
operating performance.
Our stock market price may also be dependent upon the valuations and recommendations of the analysts who cover our business. If our results do not
meet these analysts’ forecasts, the expectations of our investors or the financial guidance we provide to investors in any period, the market price of our common
stock could decline. In the past, following periods of volatility in the market or significant price decline, securities class-action litigation has often been instituted
against companies and we have been subject to such suits, as further described in “Item 15. Exhibits and Financial Statement Schedules - Note 23. Legal and
Regulatory Matters”. Such suits could result in substantial costs and diversion of management’s attention and resources, which could materially and adversely
affect our business, results of operations and financial condition.
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Our continued growth is dependent on our ability to continue to successfully develop and commercialize new products in a timely manner.
Our financial results depend upon our ability to introduce and commercialize additional generic and branded products in a timely manner. In the generic
pharmaceutical products market, revenue from newly launched generic products that we are the first to market is typically relatively high during the period
immediately following launch and can be expected generally to decline over time. Revenue from generic drugs in general, including prices of generic products that
have generic alternatives on the market, can generally be expected to decline over time. Revenue from branded pharmaceutical products can be expected to decline
as the result of entry of new competitors, particularly of companies producing generic versions of the branded products. Our continued growth is therefore
dependent upon our ability to continue to successfully introduce and commercialize new generic and branded products.
As of December 31, 2016 , we had 25 product applications pending at the FDA and 26 product candidates under development for generic versions of
brand-name pharmaceuticals. In our branded products division, we have a few product candidates in various stages of development, including IPX203, a new
extended-release oral capsule formulation of carbidopa and levodopa, as a potential treatment for symptoms of Parkinson’s disease. The development and
commercialization process for our products, particularly of our branded products, is time-consuming, costly and involves a high degree of business risk. The FDA
and the regulatory authorities may not approve our products submitted to them or our other products under development. Additionally, we may not successfully
complete our development efforts. Even if the FDA approves our products, we may not be able to market them successfully or profitably or, with respect to our
generics products, we may not be able to market them at all if we do not prevail in the patent infringement litigation in which we are involved. Our future results of
operations will depend significantly upon our ability to timely develop, receive FDA approval for, and market new pharmaceutical products or otherwise acquire
new products.
We face intense competition from both brand-name and generic pharmaceutical companies.
The pharmaceutical industry is highly competitive and many of our competitors have longer operating histories and substantially greater financial,
research and development, marketing, and other resources than we have. Further, the pharmaceutical industry has in recent years seen increased consolidation,
resulting in larger competitors and placing further pressure on prices, development activities and customer retention. In addition, pharmaceutical manufacturers’
customer base consists of an increasingly limited number of large pharmaceutical wholesalers, chain drug stores that warehouse products, mass merchandisers and
mail order pharmacies. Our competitors may be able to develop products competitive with or more effective or less expensive than our own for many reasons,
including that they may have:
proprietary processes or delivery systems;
•
greater resources in the area of research and development and marketing;
•
•
larger or more efficient production capabilities;
• more expertise in a particular therapeutic area;
• more expertise in preclinical testing and human clinical trials;
• more experience in obtaining required regulatory approvals, including FDA approval;
• more products; or
• more experience in developing new drugs and financial resources, particularly with regard to brand manufacturers.
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In the generic products market, we face competition from other generic pharmaceutical companies, which may impact our selling price and revenues from
such products. The FDA approval process often results in the FDA granting final approval to a number of ANDAs for a given product at the time a patent for a
corresponding brand product or other market exclusivity expires. This often forces us to face immediate competition when we introduce a generic product into the
market. As competition from other generic pharmaceutical companies intensifies, selling prices and gross profit margins often decline, which has been our
experience with our existing products. Moreover, with respect to products for which we file a Paragraph IV certification, if we are not the first ANDA filer
challenging a listed patent for a product, we are at a significant disadvantage to the competitor that first filed an ANDA for that product containing such a
challenge, which is awarded 180 days of market exclusivity for the product. Conversely, in some cases when we are the first ANDA filer to challenge a listed
patent, we may forfeit our 180 days of market exclusivity under certain circumstances. In that case, a competitor may obtain ANDA approval earlier than we obtain
ANDA approval, in which case we will be at a disadvantage to such competitor. Accordingly, the level of market share, revenue and gross profit attributable to a
particular generic product that we develop is generally related to the number of competitors in that product’s market and the timing of that product’s regulatory
approval and launch, in relation to competing approvals and launches. Although we cannot assure, we strive to develop and introduce new products in a timely and
cost effective manner to be competitive in our industry (see “Item 1 Business — Regulation”). Additionally, ANDA approvals often continue to be granted for a
given product subsequent to the initial launch of the generic product. These circumstances generally result in significantly lower prices and reduced margins for
generic products compared to brand products. New generic market entrants generally cause continued price and margin erosion over the generic product life cycle.
In addition to the competition we face from other generic pharmaceutical companies related to our generic products, we also face competition from brand-
name pharmaceutical companies that may try to prevent, discourage or delay the use of generic versions through various measures, including introduction of new
branded products, legislative initiatives, changing dosage forms or dosing regimens, regulatory processes, filing new patents or patent extensions, lawsuits,
citizens’ petitions, and negative publicity prior to introduction of a generic product. In addition, brand-name competitors may lower their prices to compete with
generic products, increase advertising, or launch, either through an affiliate or licensing arrangements with another company, an authorized generic at or near the
time the first generic product is launched, reducing the generic product market exclusivity provided by the Hatch-Waxman Act.
Our principal competitors in the generic pharmaceutical products market are Teva Pharmaceutical Industries Ltd., Mylan N.V., Sun Pharmaceutical
Industries Ltd., Lannett Company, Inc., Lupin Pharmaceuticals, Inc., Endo International plc and Sandoz.
In the brand-name pharmaceutical market, our principal competitors are pharmaceutical companies that are focused on Parkinson’s disease and other CNS
disorders. In addition, with respect to products that we are developing internally and/or any additional products we may in-license from third parties, we expect
that we will face increased competition from large pharmaceutical companies, drug delivery companies and other specialty pharmaceutical companies that have
focused on the same disorders as our branded products.
Any of the actions by our competitors as described above may significantly impact sales of our generic and branded products, which could have a material
adverse effect on our business, results of operations and financial condition.
Manufacturing or quality control problems may damage our reputation for quality production, demand costly remedial activities and negatively impact our
business, results of operations and financial condition.
As a pharmaceutical company, we are subject to substantial regulation by various governmental authorities. For instance, we must comply with
requirements of the U.S. Food and Drug Administration (“FDA”) and other healthcare regulators with respect to the manufacture, labeling, sale, distribution,
marketing, advertising, promotion and development of pharmaceutical products. We must register our facilities, whether located in the United States or elsewhere,
with the FDA as well as regulators outside the United States, and our products must be made in a manner consistent with current good manufacturing practices
(“cGMP”), or similar standards in each territory in which we manufacture. The failure of one of our facilities, or a facility of one of our third party suppliers, to
comply with applicable laws and regulations may lead to breach of representations made to our customers or to regulatory or government action against us related
to products made in that facility.
In addition, the FDA and other agencies periodically inspect our manufacturing facilities. Following an inspection, an agency may issue a notice listing
conditions that are believed to violate cGMP or other regulations, or a warning letter for violations of “regulatory significance” that may result in enforcement
action if not promptly and adequately corrected. We have in the past received a warning letter from the FDA regarding certain operations within our manufacturing
network at our Hayward manufacturing facility, which we subsequently resolved in 2015. We remain committed to continuing to improve our quality control and
manufacturing practices; however, we cannot be assured that the FDA will continue to be satisfied with our corrective
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actions and with our quality control and manufacturing systems and standards. Failure to comply strictly with these regulations and requirements may damage our
reputation and lead to financial penalties, compliance expenditures, the recall or seizure of products, total or partial suspension of production and/or distribution,
withdrawal or suspension of the applicable regulator’s review of our submissions, enforcement actions, injunctions and criminal prosecution. Further, other federal
agencies, our customers and partners in our alliance, development, collaboration and other partnership agreements with respect to our products and services may
take any such FDA observations or warning letters into account when considering the award of contracts or the continuation or extension of such partnership
agreements. Because regulatory approval to manufacture a drug is site-specific, the delay and cost of remedial actions, or obtaining approval to manufacture at a
different facility, could negatively impact our business. Any failure by us to comply with applicable laws and regulations and/or any actions by the FDA and other
agencies as described above could have a material adverse effect on our business, financial position and results of operations.
If we are unable to manage our growth, our business will suffer.
We have experienced rapid growth in the past several years, including through acquisitions such as the Tower Acquisition in 2015 and the Teva
Transaction in 2016, and anticipate continued rapid expansion in the future. This growth has required us to expand, upgrade, and improve our administrative,
operational, and management systems, internal controls and resources. Although we cannot assure you that we will, in fact, grow as we expect, if we fail to manage
growth effectively or to develop a successful marketing approach, our business and financial results will be materially harmed. We may also seek to expand our
business through complementary or strategic acquisitions of other businesses, products or assets, or through joint ventures, strategic agreements or other
arrangements. Any such acquisitions, joint ventures or other business combinations may involve significant integration challenges, operational complexities and
time consumption and require substantial resources and effort. It may also disrupt our ongoing businesses, which may adversely affect our relationships with
customers, employees, regulators and others with whom we have business or other dealings. Further, if we are unable to realize synergies or other benefits
expected to result from any acquisitions, joint ventures or other business combinations, or to generate additional revenue to offset any unanticipated inability to
realize these expected synergies or benefits, our growth and ability to compete may be impaired, which would require us to focus additional resources on the
integration of operations rather than other profitable areas of our business, and may otherwise cause a material adverse effect on our business, results of operations
and financial condition.
We may make acquisitions of, or investments in, complementary technologies, businesses or products, which may be on terms that are not commercially
advantageous, may require additional debt or equity financing, and may involve numerous risks, including the risks that we may be unable to integrate the
acquired business successfully and that we may assume liabilities that adversely affect us.
We regularly review the potential acquisition of technologies, products, product rights and complementary businesses. We may choose to enter into such
transactions at any time. Nonetheless, we cannot provide assurance that we will be able to identify suitable acquisition or investment candidates. To the extent that
we do identify candidates that we believe to be suitable, we cannot provide assurance that we will be able to make such acquisitions or investments on
commercially advantageous terms or at all. Further, there are a number of risks and uncertainties relating to closing such transactions. If such transactions are not
completed for any reason, we will be subject to several risks, including the following: (i) the market price of shares of our common stock may reflect a market
assumption that such transactions will occur, and a failure to complete such transactions could result in a negative perception by the market of us generally and a
decline in the market price of our common stock; and (ii) many costs relating to the such transactions may be payable by us whether or not such transactions
are completed.
If we make any acquisitions or investments, we may finance such acquisitions or investments through our cash reserves, debt financing, or by issuing
additional equity securities, which could dilute the holdings of our then-existing stockholders. If we require financing, we cannot provide assurance that we will be
able to obtain required financing when needed on acceptable terms or at all. Any such acquisitions or investments could also result in an increase in goodwill,
intangible assets and amortization expenses that could ultimately negatively impact our profitability. As further described below under the risk factor “ Our
significant and increasing balances of intangible assets, including product rights and goodwill acquired, are subject to impairment testing and may result in
impairment charges, which will have a material and adverse effect on our business, financial position and results of operations, ” if the fair value of our goodwill
or intangible assets is determined at some future date to be less than its recorded value, a charge to earnings may be required. Further, our consolidated financial
statements may also be impacted in future periods based on the accuracy of our valuations of any businesses or assets we acquire. Such a charge to earnings or
impact on our consolidated financial statements could be in amounts that are material to our business, results of operations and financial condition.
Additionally, acquisitions involve numerous risks, including difficulties in assimilating the personnel, operations and products of the acquired companies,
the diversion of management’s attention from other business concerns, risks of entering markets in which we have limited or no prior experience, and the potential
loss of key employees of the acquired company. There may be overlap between our products or customers and those of an acquired entity that may create conflicts
in relationships or
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other commitments detrimental to the integrated businesses. If we are unable to successfully or timely integrate the operations of acquired companies with our
business, we may incur unanticipated liabilities and be unable to realize the revenue growth, synergies and other anticipated benefits resulting from the acquisition,
and our business, results of operations and financial condition could be materially and adversely affected.
As a result of acquiring businesses, we may incur significant transaction costs, including substantial fees for investment bankers, attorneys, accountants
and financial printing. Any acquisition could result in our assumption of unknown and/or unexpected, perhaps material liabilities. Additionally, in any acquisition
agreement, the negotiated representations, warranties and agreements of the selling parties may not entirely protect us, and liabilities resulting from any breaches
could exceed negotiated indemnity limitations.
Our significant and increasing balances of intangible assets, including product rights and goodwill acquired, are subject to impairment testing and may result
in impairment charges. Impairment charges, and the factors contributing to the incurrence of such impairment charges, could have a material and adverse
effect on our business, financial position and results of operations.
A significant amount of our total assets is related to acquired intangible assets and goodwill. At December 31, 2016, the carrying value of our goodwill,
which includes goodwill generated as a result of the Tower Acquisition, in addition to goodwill generated as a result of the December 1999 merger of Global
Pharmaceuticals Corporation and Impax Pharmaceuticals, Inc., was $207.3 million, or approximately 11% of our total assets. At December 31, 2016, the carrying
value of our acquired intangible assets, composed of currently marketed product rights, in-process research and development product rights, and future royalties
was $620.5 million, or approximately 34% of our total assets.
The amount of intangible assets and goodwill on our consolidated balance sheet has increased as a result of our recent acquisitions and may increase
further if additional acquisitions are completed in the future. For instance, the carrying value of our intangible assets increased by $18.4 million during 2016
compared to the carrying value at December 31, 2015, with the increase primarily attributable to the Teva Transaction. We regularly evaluate and will continue to
regularly evaluate whether events or circumstances have occurred to indicate all, or a portion, of the carrying amount of intangible assets or goodwill may no
longer be recoverable, in which case an impairment charge to earnings would become necessary. As part of our regular evaluation, we test indefinite-lived
intangible assets and goodwill for impairment at least annually during the fourth quarter of our fiscal year, in accordance with Financial Accounting Standards
Board (FASB) Accounting Standards Codification (ASC) 350, Intangibles - Goodwill and Other.
We may never fully realize the value of our intangibles assets and goodwill on our consolidated balance sheet, and we have incurred significant
impairment charges in the past. For instance, during the year ended December 31, 2016, we incurred $541.6 million in intangible asset impairment charges of
which $308.4 million of such charges related to certain intangible assets acquired as part of the Teva Transaction. Upon closing the Teva Transaction on August 3,
2016, we initiated the process of transferring and securing Teva’s and Allergan’s customers for the acquired products to our account. We assumed certain price
concessions would occur following the closing. However, we elected to take additional price reductions on certain of the acquired products in order to retain key
customers. These reductions produced significantly lower than expected operating cash flows from the acquired product lines and triggered an impairment charge
of $251.0 million during the third quarter of 2016. We experienced even further price reductions on certain of the products acquired in the Teva Transaction during
the fourth quarter of 2016, which resulted in $57.4 million of additional intangible asset impairment charges. During 2016, we also incurred other non-cash
impairment charges on certain of our intangible assets, primarily related to the products acquired in the Tower Acquisition, totaling $233.2 million. These
impairment charges arose primarily due to increased competition, price degradation, product discontinuations and delays in expected product launches. The largest
intangible asset impairment charge related to products acquired in the Tower Acquisition was for our epinephrine auto-injector product, which occurred during the
fourth quarter of 2016 and accounted for more than half of the $233.2 million in charges. The impairment charge on the epinephrine auto-injector product was
triggered by current and projected price degradation as a result of unexpected changes in the pricing environment and additional competition.
There was no impairment charge related to goodwill as a result of our annual testing in 2016.
Any future acquisitions or investments in businesses could also result in an increase in goodwill, intangible assets and amortization expenses that could
have a negative impact on our profitability. If the fair value of our goodwill or intangible assets is determined at some future date to be less than its recorded value,
a charge to earnings may be required. Any such charge or future determination requiring the write-off of a significant portion of the carrying value of our goodwill
or intangible assets, and the factors leading to the incurrence of such charges or write-off, could have a material adverse effect on our business, results of
operations and financial condition.
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A substantial portion of our total revenues is derived from sales to a limited number of customers.
We derive a substantial portion of our revenue from sales to a limited number of customers. In 2016 , our five major customers, McKesson Corporation,
Cardinal Health, Amerisource-Bergen, N.C. Mutual and CVS Caremark Corporation accounted for 40%, 28%, 20%, 1% and 1%, respectively, or an aggregate of
90%, of our gross revenue.
A reduction in, or loss of business with, any one of these customers, or any failure of a customer to pay us on a timely basis, would adversely affect our
business.
A substantial portion of our total revenues is derived from sales of a limited number of products.
We derive a substantial portion of our revenue from sales of a limited number of products. In 2016 , our significant products accounted for 11%, 9%, 9%,
8% and 8%, or an aggregate of 45%, of our product sales, net. The sale of our products can be significantly influenced by market conditions, as well as regulatory
actions. We may experience decreases in the sale of our products in the future as a result of actions taken by our competitors, such as price reductions, or as a result
of regulatory actions related to our products or to competing products, which could have a material impact on our results of operations. Actions which could be
taken by our competitors, which may materially and adversely affect our business, results of operations and financial condition, may include, without limitation,
pricing changes and entering or exiting the market for specific products.
Sales of our products may be adversely affected by the continuing consolidation of our customer base.
A significant proportion of our sales is made to relatively few retail drug chains, wholesalers, and managed care organizations. These customers are
continuing to undergo significant consolidation. Such consolidation has provided and may continue to provide them with additional purchasing leverage, and
consequently may increase the pricing pressures that we face. Additionally, the emergence of large buying groups representing independent retail pharmacies, and
the prevalence and influence of managed care organizations and similar institutions, enable those groups to extract price discounts on our products.
Our net sales and quarterly growth comparisons may also be affected by fluctuations in the buying patterns of retail chains, major distributors and other
trade buyers, whether resulting from pricing, wholesaler buying decisions or other factors. In addition, since such a significant portion of our revenues is derived
from relatively few customers, any financial difficulties experienced by a single customer, or any delay in receiving payments from a single customer, could have a
material adverse effect on our business, results of operations and financial condition.
We have experienced operating losses and negative cash flow from operations in the past, and our future profitability is uncertain.
Although we have in recent years been profitable, we experienced a net loss during the year ended December 31, 2016 and cannot assure that our business
will return to profitability or generate positive cash flow in the future. To remain operational and profitable, we must, among other things:
•
•
•
•
•
obtain FDA approval of our products;
successfully launch and market new products;
prevail in patent infringement litigation in which we are involved;
continue to generate or obtain sufficient capital on acceptable terms to fund our operations; and
comply with the many complex governmental regulations that deal with virtually every aspect of our business activities.
A valuation allowance may be required for our deferred tax assets, which could reduce our earnings and have a material adverse effect on our business,
results of operations and financial condition.
Our inability to realize deferred tax assets may have a material and adverse effect on our business, results of operations and financial condition. Deferred
tax assets are recorded for net operating losses and temporary differences between the book and tax basis of assets and liabilities expected to produce tax
deductions in future periods. The ultimate realization of the deferred tax assets is dependent upon the generation of future taxable income during the periods in
which those deferred tax assets would be deductible. We assess the realizability of the deferred tax assets each period by considering whether it is more likely than
not that all or a portion of our deferred tax assets will not be realized. If we conclude that it is more likely than not that the deferred tax assets will not be realized,
we record a valuation allowance against the net deferred tax asset. For instance, we experienced an operating loss for the year ended December 31, 2016 due in
large part to impairment charges we incurred during the year. We weighed both the positive and negative evidence available, such as scheduled reversal of deferred
tax liabilities, prior earnings
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history, projected future earnings, carry-back and carry-forward periods and the feasibility of ongoing tax strategies that could potentially enhance the likelihood of
the realization of a deferred tax asset. The weight given to the positive and negative evidence is commensurate with the extent the evidence may be objectively
verified. As such, it is generally difficult for positive evidence regarding projected future taxable income exclusive of reversing taxable temporary differences and
carryforwards to outweigh objective negative evidence of a recent financial reporting loss for the year ended December 31, 2016. Based on an evaluation of both
the positive and negative evidence available we determined that it was necessary to establish a valuation allowance against a significant portion of our net deferred
tax assets for the fiscal year ended December 31, 2016. The valuation allowance reduces earnings and our shareholders’ equity and increases the balance sheet
leverage as measured by debt-to-total capitalization. The valuation allowance will remain until such time, if ever, that we can determine that the net deferred tax
assets are more likely than not to be realized.
The terms of our revolving credit facility, term loan facility, and the indenture governing our 2.00% Convertible Senior Notes Due June 2022 impose financial
and operating restrictions on us.
We have a $200.0 million senior secured revolving credit facility (the “Revolving Credit Facility”) and a $400.0 million term loan (the "Term Loan
Facility", and together with the Revolving Credit Facility, the "RBC Credit Facilities") pursuant to an amended credit agreement, dated as of August 3, 2016, by
and among us, the lenders party thereto from time to time and Royal Bank of Canada, as administrative agent and collateral agent. We are also party to an
indenture dated June 30, 2015 between us and Wilmington Trust, National Association (the “Indenture”) governing our 2.00% Convertible Senior Notes due 2022
(the “Notes”). Refer to “Item 15. Exhibits and Financial Statement Schedules - Note 13. Debt” for a detailed description of our outstanding indebtedness.
Our RBC Credit Facilities and Indenture contain a number of negative covenants that limit our ability to engage in activities. These covenants limit or
restrict, among other things, our ability to:
incur additional debt, guarantee other obligations or grant liens on our assets;
•
• make certain loans or investments;
•
• make optional payments or modify certain debt instruments;
•
undertake certain acquisitions, mergers or consolidations, or dispose of assets;
pay dividends or other payments on our capital stock, enter into arrangements that restrict our and our restricted subsidiaries’ ability to pay dividends
or grant liens; or
engage in certain transactions with our affiliates.
•
The terms of our RBC Credit Facilities also include a financial covenant which requires us to maintain a certain total net leverage ratio. These limitations
and restrictions may adversely affect our ability to finance our future operations or capital needs or engage in other business activities that may be in our best
interests. If we breach any of the covenants in our RBC Credit Facilities or Indenture, we may be in default and our borrowings under the facilities and the Notes
could be declared due and payable, including accrued interest and other fees, which could have a material adverse effect on our business, results of operations and
financial condition.
Our level of indebtedness and liabilities could limit cash flow available for our operations, expose us to risks that could adversely affect our business, results of
operations and financial condition and impair our ability to satisfy our obligations under our convertible notes and other debt instruments.
At December 31, 2016 , our total consolidated liabilities were $1.2 billion, including $600.0 million of outstanding convertible notes and a $400.0 million
term loan. Refer to “Item 15. Exhibits and Financial Statement Schedules - Note 13. Debt” for a detailed description of our outstanding indebtedness. We may also
incur additional indebtedness to meet future financing needs. Our indebtedness could have significant negative consequences for our business, results of operations
and financial condition, including:
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•
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increasing our vulnerability to adverse economic and industry conditions;
limiting our ability to obtain additional financing;
requiring the dedication of a substantial portion of our cash flow from operations to service our indebtedness, thereby reducing the amount of our
cash flow available for other purposes;
limiting our flexibility in planning for, or reacting to, changes in our business;
dilution experienced by our existing stockholders as a result of the conversion of the convertible notes into shares of common stock; and
placing us at a possible competitive disadvantage with less leveraged competitors and competitors that may have better access to capital resources.
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We cannot assure you that we will be able to continue to maintain sufficient cash reserves or continue to generate cash flow from operations at levels
sufficient to permit us to pay principal, premium, if any, and interest on our indebtedness, or that our cash needs will not increase. If we are unable to generate
sufficient cash flow or otherwise obtain funds necessary to make required payments, or if we fail to comply with the various requirements of our indebtedness then
outstanding, we would be in default, which would permit the holders of the affected indebtedness to accelerate the maturity of such indebtedness and could cause
defaults under our other indebtedness. Any default under any indebtedness could have a material adverse effect on our business, results of operations and financial
condition.
We may need to raise additional funds in the future which may not be available on acceptable terms or at all.
We may consider issuing additional debt or equity securities in the future to fund potential acquisitions or investments, to refinance existing debt, or for
general corporate purposes. If we issue equity, convertible preferred equity or convertible debt securities to raise additional funds, our existing stockholders may
experience dilution, and the new equity or debt securities may have rights, preferences and privileges senior to those of our existing shareholders. If we incur
additional debt, it may increase our leverage relative to our earnings or to our equity capitalization, requiring us to pay additional interest expenses and potentially
lowering our credit ratings. We may not be able to market such issuances on favorable terms, or at all, in which case, we may not be able to develop or enhance
our products, execute our business plan, take advantage of future opportunities, or respond to competitive pressures or unanticipated customer requirements.
Any delays or unanticipated expenses in connection with the operation of our limited number of facilities could have a material adverse effect on our business.
A substantial portion of our manufacturing capacity as well as our current production is attributable to our manufacturing facilities located in Hayward,
California, Middlesex, New Jersey and Taiwan, R.O.C. and to certain third party suppliers. A significant disruption at any one of these facilities within our internal
or third party supply chain, even on a short-term basis, whether due to an adverse quality or compliance observation, including a total or partial suspension of
production and/or distribution by regulatory authorities, an act of God, terrorism, civil or political unrest, or other events could impair our ability to produce and
ship products to the market on a timely basis and could, among other consequences, subject us to exposure to claims from customers. Any of these events could
have a material adverse effect on our business, results of operations and financial condition.
Our business is subject to the economic, political, legal and other risks of maintaining facilities and conducting clinical trials in foreign countries.
We currently ship commercial products from our manufacturing facility in Taiwan. We also conduct certain clinical trials for our product candidates at
multiple sites in Europe. These foreign operations are subject to risks inherent in maintaining operations and doing business abroad, such as economic and political
destabilization, international conflicts, restrictive actions by foreign governments, expropriation or nationalization of property, changes in laws and regulations,
changes in regulatory requirements, the difficulty of effectively managing diverse global operations, adverse foreign tax or tariff laws, more limited intellectual
property protection in certain foreign jurisdictions, and the threat posed by potential international disease pandemics in countries that do not have the resources
necessary to deal with such outbreaks. Further, as our global operations require compliance with a complex set of foreign and U.S. laws and regulations, including
data privacy requirements, labor relations laws, tax laws, anti-competition regulations, import and trade restrictions, export requirements, U.S. laws such as the
Foreign Corrupt Practices Act of 1977, as amended, and local laws which also prohibit payments to governmental officials or certain payments or remunerations to
customers, there is a risk that some provisions may be inadvertently breached. Violations of these laws and regulations could result in fines, criminal sanctions
against us, our officers or our employees, and prohibitions on the conduct of our business. These foreign economic, political, legal and other risks could impact our
operations and have an adverse effect on our business, results of operations and financial condition.
We are involved in various legal proceedings, including patent litigation that can delay or prevent our commercialization of generic products or accelerate
generic competition for our branded products, all of which are uncertain, force us to incur substantial expense to defend and/or expose us to substantial
liability.
Patent infringement litigation involves many complex technical and legal issues and its outcome is often difficult to predict, and the risk involved in doing
so can be substantial. For generic product manufacturers, the potential consequences to such generic companies in the event of an unfavorable outcome include
delaying generic launch until patent expiration and potential damages measured by the profits lost by the branded product manufacturer rather than the profits
earned by the generic pharmaceutical company. For brand drug manufacturers, an unfavorable outcome may significantly accelerate generic competition ahead of
patent expiration. Such litigation usually involves significant expense and can delay or prevent introduction or sale of
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our products. Our generic products division is routinely subject to patent infringement litigation brought by branded pharmaceutical manufacturers seeking to delay
FDA approval to manufacture and market generic forms of their branded products. Likewise, our branded products division is currently involved in patent
infringement litigation against generic drug manufacturers seeking FDA approval to market their generic drugs prior to expiration of patents covering our branded
products.
We and/or our third party partners are routinely subject to patent infringement suits related to our Generics Division products, including as of
December 31, 2016 , one related to oxymorphone hydrochloride tablets. If this or any of our future patent litigation matters involving generic products are resolved
unfavorably, we or our alliance or collaboration partners may be enjoined from manufacturing, developing or selling the generic product that is the subject of such
litigation without a license from the other party. In addition, if we decide to market and sell generic products prior to the resolution of patent infringement suits, we
could be held liable for lost profits if we are found to have infringed a valid patent, or liable for treble damages if we are found to have willfully infringed a valid
patent. In our branded products division, as of December 31, 2016 , we were involved in two patent infringement suits related to Zomig ® nasal spray and one
patent infringement suit related to Rytary ® . If these patent litigation matters involving our branded products are resolved unfavorably, our Zomig ® nasal spray
product and/or Rytary ® may face generic competition significantly earlier than the date of patent expirations for the products. We have incurred substantial
expense to defend the foregoing patent litigation suits; during fiscal year 2016 , we incurred costs of $7.8 million in connection with our participation in the patent
litigation matters described above, as well as for other matters that were resolved in 2016 . Although it is not currently possible to quantify the liability we could
incur if any of the above referenced patent litigation suits are decided against us, any unfavorable outcome on such matters could have a material adverse effect on
our business, results of operations and financial condition.
In addition to patent infringement litigation claims, we are or may become a party to other litigation in the ordinary course of our business, including,
among others, matters alleging product liability, other intellectual property rights infringement, violations of securities laws, employment discrimination or breach
of commercial contract. A detailed description of our significant legal proceedings are described in “Item 15. Exhibits and Financial Statement Schedules – Note
22. Legal and Regulatory Matters.” In general, litigation claims can be expensive and time consuming to bring or defend against and could result in settlements or
damages that could have a material adverse effect on our business, results of operations and financial condition.
Our agreements to settle patent litigations, which are important to our business, are facing increased government scrutiny in the United States, which may
result in increased government actions and private litigation suits.
We are involved in numerous patent litigations in which we challenge the validity or enforceability of innovator companies’ listed patents and/or their
applicability to our generic pharmaceutical products, as well as patent infringement litigation in which generic companies challenge the validity or enforceability of
our patents and/or their applicability to their generic pharmaceutical products, and therefore settling patent litigations has been and is likely to continue to be an
important part of our business. Parties to such settlement agreements in the United States, including us, are required by law to file them with the Federal Trade
Commission (“FTC”) and the Antitrust Division of the Department of Justice for review. The FTC has publicly stated that, in its view, some of the brand - generic
settlement agreements violate the antitrust laws and has brought actions against some brand and generic companies that have entered into such agreements. In June
2013, the U.S. Supreme Court in its decision in FTC v. Actavis determined that “reverse payment” settlement agreements between brand and generic companies
could violate antitrust laws. The Supreme Court held that such settlement agreements are neither immune from antitrust attack nor presumptively illegal but rather
should be analyzed under the “Rule of Reason.” It is currently uncertain the effect the Supreme Court’s decision will have on our existing settlement agreements or
its impact on our ability to enter into such settlement agreements in the future or the terms thereof. The Supreme Court’s decision may result in heightened scrutiny
from the FTC of such settlement agreements and we may become subject to increased FTC investigations or enforcement actions arising from such settlement
agreements. Further, private plaintiffs, including direct and indirect purchasers of our products, may also become more active in bringing private litigation claims
against us and other brand and generic pharmaceutical companies alleging that such settlement agreements violate antitrust laws.
We previously received a civil investigative demand (“CID”) from the FTC concerning its investigation into the drug Solodyn ® and its generic
equivalents to determine whether we, along with Medicis Pharmaceutical Corporation (now a wholly owned subsidiary of Valeant Pharmaceuticals International,
Inc.) and six other companies, had engaged or were engaged in unfair methods of competition in or affecting commerce by entering into agreements related to the
product or its generic equivalents. The investigation was closed in November 2015 with no further action by the FTC. We are also currently subject to a suit by the
FTC filed in March 2016 against us, Endo Pharmaceuticals, Inc. (“Endo”), and others alleging that we and Endo violated antitrust laws when we entered into a
June 2010 co-promotion and development agreement and a June 2010 settlement agreement that resolved patent litigation in connection with our submission of our
ANDA for generic original Opana® ER. On January 19, 2017, the FTC filed a Part 3 Administrative complaint against us with similar allegations regarding our
June 2010 settlement agreement with Endo. We filed our answer to the Administrative Complaint on February 7, 2017 and trial is expected in September 2017.
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Private plaintiffs have also filed class action complaints against us and other manufacturers of Solodyn ® , Opana ® ER and their respective generic
equivalents. A detailed description of the Opana ® ER FTC investigation and class action suit and the Solodyn ® class action suit are described in “Item 15. Exhibits
and Financial Statement Schedules - Note 22. Legal and Regulatory Matters.” The defense of antitrust investigation and claims are generally expensive and time
consuming, and we can give no assurance as to the timing or outcome of such investigation or claims or of any future private litigation or government action
alleging that one of our settlement agreements violates antitrust laws.
Our ability to develop or license, or otherwise acquire, and introduce new products on a timely basis in relation to our competitors’ product introductions
involves inherent risks and uncertainties.
Product development is inherently risky, especially for new drugs for which safety and efficacy have not been established and the market is not yet
proven. Likewise, product licensing involves inherent risks including uncertainties due to matters that may affect the achievement of milestones, as well as the
possibility of contractual disagreements with regard to terms such as license scope or termination rights. The development and commercialization process,
particularly with regard to new drugs, also requires substantial time, effort and financial resources. The process of obtaining FDA approval to manufacture and
market new pharmaceutical products is rigorous, time consuming, costly and largely unpredictable. We, or a partner, may not be successful in obtaining FDA
approval or in commercializing any of the products that we are developing or licensing.
Our approved products may not achieve expected levels of market acceptance.
Even if we are able to obtain regulatory approvals for our new products, the success of those products is dependent upon market acceptance. Levels of
market acceptance for our new products could be affected by several factors, including:
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the availability of alternative products from our competitors;
the prices of our products relative to those of our competitors;
the timing of our market entry;
the ability to market our products effectively at the retail level;
the perception of patients and the healthcare community, including third-party payers, regarding the safety, efficacy and benefits of our drug products
compared to those of competing products; and
the acceptance of our products by government and private formularies.
Some of these factors are not within our control, and our products may not achieve expected levels of market acceptance. Additionally, continuing and
increasingly sophisticated studies of the proper utilization, safety and efficacy of pharmaceutical products are being conducted by the industry, government
agencies and others which can call into question the utilization, safety and efficacy of previously marketed products. In some cases, studies have resulted, and may
in the future result, in the discontinuance of product marketing or other risk management programs such as the need for a patient registry.
Our business is highly dependent on market perceptions of us and the safety and quality of our products. Our business, products or product pricing could be
subject to negative publicity, which could have a material adverse effect on our business, results of operations and financial condition.
Market perceptions of our business are very important to us, especially market perceptions of the safety and quality of our products. If any of our products
or similar products that other companies distribute are subject to market withdrawal or recall or are proven to be, or are claimed to be, harmful to consumers, then
this could have a material adverse effect on our business, results of operations and financial condition. Also, because our business is dependent on market
perceptions, negative publicity associated with product quality, illness or other adverse effects resulting from, or perceived to be resulting from, our products could
have a material adverse impact on our business, results of operations and financial condition.
There has also recently been significant publicity regarding the pricing of pharmaceutical products more generally, including publicity and pressure
resulting from prices charged by competitors and peer companies for new products as well as price increases by competitors and peer companies on older products
that the public has deemed excessive. Any downward pricing pressure on the price of certain of our products arising from social or political pressure to lower the
cost of pharmaceutical products could have a material adverse impact on our business, results of operations and financial condition.
Accompanying the press and media coverage of pharmaceutical pricing practices and public complaints about the same, there has been increasing U.S.
federal and state legislative and enforcement interest with respect to drug pricing. For instance, the United States Department of Justice issued subpoenas to
pharmaceutical companies, including us, seeking information about the sales, marketing and pricing of certain generic drugs. A detailed description of the United
States Department of Justice’s investigation is described in “Item 15. Exhibits and Financial Statement Schedules - Note 22. Legal and Regulatory Matters”. In
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addition to the effects of any investigations or claims brought against us, our business, results of operations and financial condition could also be adversely affected
if any such inquiries, of us or of other pharmaceutical companies or the industry more generally, were to result in legislative or regulatory proposals that limit our
ability to increase the prices of our products
We may discontinue the manufacture and distribution of certain existing products, which may adversely impact our business, results of operations and
financial condition.
We continually evaluate the performance of our products, and may determine that it is in our best interest to discontinue the manufacture and distribution
of certain of our products. We cannot guarantee that we have correctly forecasted, or will correctly forecast in the future, the appropriate products to discontinue or
that our decision to discontinue various products is prudent if market conditions change. In addition, we cannot assure you that the discontinuance of products will
reduce our operating expenses or will not cause us to incur material charges associated with such a decision. Furthermore, the discontinuance of existing products
entails various risks, including, in the event that we decide to sell the discontinued product, the risk that we will not be able to find a purchaser for such products or
that the purchase price obtained will not be equal to at least the book value of the net assets for such products. Other risks include managing the expectations of,
and maintaining good relations with, our customers who previously purchased products from our discontinued products, which could prevent us from selling other
products to them in the future. Moreover, we may incur other significant liabilities and costs associated with our discontinuance of products, which could have a
material adverse effect on our business, results of operations and financial condition.
We expend a significant amount of resources on research and development efforts that may not lead to successful product introductions or the recovery of our
research and development expenditures.
We conduct research and development primarily to enable us to manufacture and market pharmaceuticals in accordance with FDA regulations. We spent
$80.5 million, $70.6 million and $78.6 million on research and development activities during the years ended December 31, 2016 , 2015 and 2014 , respectively.
We are required to obtain FDA approval before marketing our drug products. The FDA approval process is costly and time consuming. Typically, research
expenses related to the development of innovative products and the filing of NDAs are significantly greater than those expenses associated with ANDAs. As we
continue to develop new products, our research expenses will likely increase. Because of the inherent risk associated with research and development efforts in our
industry, our research and development expenditures may not result in the successful introduction of FDA-approved pharmaceuticals.
Our bioequivalence studies, other clinical studies and/or other data may not result in FDA approval to market our new drug products. While we believe
that the FDA’s ANDA procedures will apply to our bioequivalent versions of branded drugs, these drugs may not be suitable for, or approved as part of, these
abbreviated applications. In addition, even if our drug products are suitable for FDA approval by filing an ANDA, the abbreviated applications are costly and time
consuming to complete. After we submit a NDA or ANDA, the FDA may require that we conduct additional studies, and as a result, we may be unable to
reasonably determine the total research and development costs to develop a particular product. Also, for products pending approval, we may obtain raw materials
or produce batches of inventory to be used in anticipation of the product’s launch. In the event that FDA approval is denied or delayed, we could be exposed to the
risk of this inventory becoming obsolete. Finally, we cannot be certain that any investment made in developing products or product-delivery technologies will be
recovered, even if we are successful in commercialization. To the extent that we expend significant resources on research and development efforts and are not able,
ultimately, to introduce successful new products or new delivery technologies as a result of those efforts, we will be unable to recover those expenditures.
The time necessary to develop generic drugs may adversely affect whether, and the extent to which, we receive a return on our capital.
We generally begin our development activities for a new generic drug product several years in advance of the patent expiration date of the brand-name
drug equivalent. The development process, including drug formulation, testing, and FDA review and approval, often takes three or more years. This process
requires that we expend considerable capital to pursue activities that do not yield an immediate or near-term return. Also, because of the significant time necessary
to develop a product, the actual market for a product at the time it is available for sale may be significantly less than the originally projected market for the product.
If this were to occur, our potential return on our investment in developing the product, if approved for marketing by the FDA, would be adversely affected and we
may never receive a return on our investment in the product. It is also possible for the manufacturer of the brand-name product for which we are developing a
generic drug to obtain approvals from the FDA to switch the brand-name drug from the prescription market to the OTC market. If this were to occur, we would be
prohibited from marketing our product other than as an OTC drug, in which case revenues could be substantially less than we anticipated.
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Research and development efforts invested in our branded pharmaceutical products may not achieve expected results.
We invest increasingly significant resources to develop our branded products, both through our own efforts and through collaborations, in-licensing and
acquisition of products from or with third parties. The development of proprietary branded drugs involves processes and expertise different from those used in the
development of generic products, which increases the risks of failure that we face. For example, the time from discovery to commercial launch of a branded
product can be 15 years or even longer, and involves multiple stages: not only intensive preclinical and clinical testing, but also highly complex, lengthy and
expensive approval processes which can vary from country to country. The longer it takes to develop a product, the longer time it may take for us to recover our
development costs and generate profits, if at all.
During each development stage, we may encounter obstacles that delay the process or approval and increase expenses, leading to significant risks that we
will not achieve our goals and may be forced to abandon a potential product in which we have invested substantial amounts of time and money. These obstacles
may include: preclinical failures; difficulty enrolling patients in clinical trials; delays in completing formulation and other work needed to support an application
for approval; adverse reactions or other safety concerns arising during clinical testing; insufficient clinical trial data to support the safety or efficacy of the product
candidate; and failure to obtain, or delays in obtaining, the required regulatory approvals for the product candidate or the facilities in which it is manufactured. As a
result of the obstacles noted above, our investment in research and development of branded products can involve significant costs with no assurances of future
revenues or profits.
Approvals for our new generic drug products may be delayed or become more difficult to obtain if the FDA institutes changes to its approval requirements.
The FDA may institute changes to its ANDA approval requirements, such as implementing new or additional fees similar to the fees imposed by the
Generic Drug Fee User Amendments of 2012 (“GDUFA”) and its proposed second iteration (GDUFA II), which may make it more difficult or expensive for us to
obtain approval for our new generic products. The FDA may also implement other changes that may directly affect some of our ANDA filings pending approval
from the FDA, such as changes to guidance from the FDA regarding bioequivalency requirements for particular drugs. Such changes may cause our development
of such generic drugs to be significantly more difficult or result in delays in FDA approval or result in our decision to abandon or terminate certain projects. Any
changes in FDA requirements may make it more difficult for us to file ANDAs or obtain approval of our ANDAs and generate revenues and thus have a material
adverse effect on our business, results of operations and financial condition.
The risks and uncertainties inherent in conducting clinical trials could delay or prevent the development and commercialization of our own branded products,
which could have a material adverse effect on our business, results of operations and financial condition.
With respect to our branded products which do not qualify for the FDA’s abbreviated application procedures, we must demonstrate through clinical trials
that these products are safe and effective for use. We have only limited experience in conducting and supervising clinical trials. The process of completing clinical
trials and preparing a NDA may take several years and requires substantial resources. Our studies and filings may not result in FDA approval to market our new
drug products and, if the FDA grants approval, we cannot predict the timing of any approval. There are substantial filing fees for NDAs that are not refundable if
FDA approval is not obtained.
There are a number of risks and uncertainties associated with clinical trials. The results of clinical trials may not be indicative of results that would be
obtained from large scale testing. Clinical trials are often conducted with patients having advanced stages of disease and, as a result, during the course of treatment
these patients can die or suffer adverse medical effects for reasons that may not be related to the pharmaceutical agents being tested, but which nevertheless affect
the clinical trial results. In addition, side effects experienced by the patients may cause delay of approval or limit the profile of an approved product. Moreover, our
clinical trials may not demonstrate sufficient safety and efficacy to obtain approval from the FDA or foreign regulatory authorities. The FDA or foreign regulatory
authorities may not agree with our assessment of the clinical data or they may interpret it differently. Such regulatory authorities may require additional or
expanded clinical trials. Even if the FDA or foreign regulatory authorities approve certain products developed by us, there is no assurance that such regulatory
authorities will not subject marketing of such products to certain limits on indicated use.
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Failure can occur at any time during the clinical trial process and, in addition, the results from early clinical trials may not be predictive of results obtained
in later and larger clinical trials, and product candidates in later clinical trials may fail to show the desired safety or efficacy despite having progressed successfully
through earlier clinical testing. A number of companies in the pharmaceutical industry, including us, have suffered significant setbacks in clinical trials, even in
advanced clinical trials after showing positive results in earlier clinical trials. The completion of clinical trials for our product candidates may be delayed or halted
for the reasons noted above in addition to many other reasons, including:
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delays in patient enrollment, and variability in the number and types of patients available for clinical trials;
regulators or institutional review boards may not allow us to commence or continue a clinical trial;
our inability, or the inability of our partners, to manufacture or obtain from third parties materials sufficient to complete our clinical trials;
delays or failure in reaching agreement on acceptable clinical trial contracts or clinical trial protocols with prospective clinical trial sites;
risks associated with trial design, which may result in a failure of the trial to show statistically significant results even if the product candidate is
effective;
difficulty in maintaining contact with patients after treatment commences, resulting in incomplete data;
poor effectiveness of product candidates during clinical trials;
safety issues, including adverse events associated with product candidates;
the failure of patients to complete clinical trials due to adverse side effects, dissatisfaction with the product candidate, or other reasons;
governmental or regulatory delays or changes in regulatory requirements, policy and guidelines; and
varying interpretation of data by the FDA or foreign regulatory authorities.
In addition, our product candidates could be subject to competition for clinical study sites and patients from other therapies under development which may
delay the enrollment in or initiation of our clinical trials.
The FDA or foreign regulatory authorities may require us to conduct unanticipated additional clinical trials, which could result in additional expense and
delays in bringing our product candidates to market. Any failure or delay in completing clinical trials for our product candidates would prevent or delay the
commercialization of our product candidates. We cannot assure that our expenses related to clinical trials will lead to the development of brand-name drugs that
will generate revenues in the near future. Delays or failure in the development and commercialization of our own branded products could have a material adverse
effect on our business, results of operations and financial condition.
We rely on third parties to conduct clinical trials and testing for our product candidates, and if they do not properly and successfully perform their legal and
regulatory obligations, as well as their contractual obligations to us, we may not be able to obtain regulatory approvals for our product candidates.
We design the clinical trials for our product candidates, but rely on contract research organizations and other third parties to assist us in managing,
monitoring and otherwise carrying out these trials, including with respect to site selection, contract negotiation, analytical testing and data management. We do not
control these third parties and, as a result, they may not treat our clinical studies as their highest priority, or in the manner in which we would prefer, which could
result in delays.
Although we rely on third parties to conduct our clinical trials and related activities, we are responsible for confirming that each of our clinical trials is
conducted in accordance with our general investigational plan and protocol. Moreover, the FDA and foreign regulatory agencies require us to comply with
regulations and standards, commonly referred to as good clinical practices and good laboratory practices, for conducting, recording and reporting the results of
clinical trials to ensure that the data and results are credible and accurate and that the trial participants are adequately protected. Our reliance on third parties does
not relieve us of these responsibilities and requirements. The FDA enforces good clinical practices and good laboratory practices through periodic inspections of
trial sponsors, principal investigators and trial sites. If we, our contract research organizations or our study sites fail to comply with applicable good clinical
practices and good laboratory practices, the clinical data generated in our clinical trials may be deemed unreliable and the FDA may require us to perform
additional clinical trials before approving our marketing applications. We cannot assure you that, upon inspection, the FDA will determine that any of our clinical
trials comply with good clinical practices and good laboratory practices. In addition, our clinical trials must be conducted with product manufactured under the
FDA’s current Good Manufacturing Practices, or cGMP, regulations. Our failure or the failure of our contract manufacturers if any are involved in the process, to
comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.
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If third parties do not successfully carry out their duties under their agreements with us, if the quality or accuracy of the data they obtain is compromised
due to failure to adhere to our clinical protocols or regulatory requirements, or if they otherwise fail to comply with clinical trial protocols or meet expected
deadlines, our clinical trials may not meet regulatory requirements. If our clinical trials do not meet regulatory requirements or if these third parties need to be
replaced, our clinical trials may be extended, delayed, suspended or terminated. If any of these events occur, we may not be able to obtain regulatory approval of
our product candidates, which could have a material adverse effect on our business, results of operations and financial condition.
We currently do not have a license partner for commercialization of Numient ® outside of the United States.
In November 2015, the European Commission granted marketing authorization for Numient ® (IPX066) (referred to as Rytary ® in the United States).
The review of the Numient ® application was conducted under the centralized licensing procedure as a therapeutic innovation, and the authorization is applicable in
all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway. We have no experience marketing or selling our pharmaceutical
products outside of the United States and Puerto Rico and to date, we have not launched commercialization activities for Numient ® outside of the United States.
We do not currently have a license partner for the commercialization of the product outside of the United States. We previously were a party to an agreement with
Glaxo Group Limited (“GSK”) whereby GSK received an exclusive license to develop and commercialize IPX066 throughout the world, except in the United
States and Taiwan, however the agreement was subsequently terminated and GSK’s rights to develop and commercialize the product outside the United States and
Taiwan were transferred back to us in 2013. We are currently engaged in discussions with potential partners to market Numient ® outside of the United States;
however, no assurances can be made that we will find such a partner. If we are unsuccessful in entering into such third party collaboration arrangements for ex-
United States commercialization activities of Numient ® , such failure could have a material adverse effect on our business, results of operations and financial
condition.
The illegal distribution and sale by third parties of counterfeit versions of our products or of stolen products could have a negative impact on our reputation
and a material adverse effect on our business, results of operations and financial condition.
Third parties could illegally distribute and sell counterfeit versions of our products, which do not meet the rigorous manufacturing and testing standards
that our products undergo. Counterfeit products are frequently unsafe or ineffective, and can be life-threatening. Counterfeit medicines may contain harmful
substances, the wrong dose of the active pharmaceutical ingredient or no active pharmaceutical ingredients at all. However, to distributors and users, counterfeit
products may be visually indistinguishable from the authentic version.
Reports of adverse reactions to counterfeit drugs or increased levels of counterfeiting could materially affect patient confidence in the authentic product. It
is possible that adverse events caused by unsafe counterfeit products will mistakenly be attributed to the authentic product. In addition, thefts of inventory at
warehouses, plants or while in-transit, which are not properly stored and which are sold through unauthorized channels could adversely impact patient safety, our
reputation and our business.
Public loss of confidence in the integrity of pharmaceutical products as a result of counterfeiting or theft could have a material adverse effect on our
business, results of operations and financial condition.
We are dependent on a small number of suppliers for our raw materials that we use to manufacture our products and interruptions in our supply chain could
materially and adversely affect our business.
The raw materials we use in the production of our products consist of pharmaceutical chemicals in various forms that are generally available from several
sources in the United States and throughout the world. In some cases, however, the raw materials, such as the active pharmaceutical ingredients (“API”) used to
manufacture our products, are available only from a single supplier. Further, even if more than one supplier exists, we may choose, and have done so in the case of
our API suppliers for a majority of our products, to list only one supplier in our product applications submitted to the FDA. The FDA requires identification of raw
material suppliers in applications for approval of drug products. If raw materials were unavailable from a specified supplier or the supplier was not in compliance
with FDA or other applicable requirements, the FDA approval of a new supplier could delay the manufacture of the drug involved. As a result, there is no
guarantee we will always have timely and sufficient access to a required raw material or other product. Generally, we would need as long as 18 months to find and
qualify a new sole-source supplier. If we receive less than one year’s termination notice from a sole-source supplier that it intends to cease supplying raw materials,
it could result in disruption of our ability to produce the drug involved. We currently do not have long-term supply agreements with the majority of our API
suppliers and although to date we have only experienced occasional interruptions in supplies, no assurance can be given that we will continue to receive
uninterrupted or adequate supplies of such raw materials.
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A significant portion of our raw materials may also be available only from foreign sources. Foreign sources can be subject to the special risks of doing
business abroad, including:
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greater possibility for disruption due to transportation or communication problems;
the relative instability of some foreign governments and economies;
interim price volatility based on labor unrest, materials or equipment shortages, export duties, restrictions on the transfer of funds, or fluctuations in
currency exchange rates; and
uncertainty regarding recourse to a dependable legal system for the enforcement of contracts and other rights.
Many third-party suppliers are subject to governmental regulation and, accordingly, we are dependent on the regulatory compliance of these third parties.
We also depend on the strength, enforceability and terms of our various contracts with these third-party suppliers. We also rely on complex shipping arrangements
throughout the various facilities of our supply chain spectrum. Customs clearance and shipping by land, air or sea routes rely on and may be affected by factors that
are not in our full control or are hard to predict.
Any inability to obtain raw materials on a timely basis, or any significant price increases which cannot be passed on to customers, could have a material
adverse effect on our business, results of operations and financial condition.
Our policies regarding returns, rebates, allowances and chargebacks, and marketing programs adopted by wholesalers may reduce our revenues in future
fiscal periods.
Based on industry practice, many generic drug manufacturers’ policies give customers post-sale inventory allowances on returns. Under these
arrangements, from time to time, we give our customers credits on our generic products that our customers hold in inventory after we have decreased the market
prices of the same generic products due to competitive pricing. Therefore, if new competitors enter the marketplace and significantly lower the prices of any of
their competing products, we would likely reduce the price of our product. As a result, we would be obligated to provide credits to our customers who are then
holding inventories of such products, which could reduce sales revenue and gross margin for the period the credit is provided. Like our competitors, we also give
credits for chargebacks to wholesalers that have contracts with us for their sales to hospitals, group purchasing organizations, pharmacies or other customers. A
chargeback is the difference between the price the wholesaler pays and the price that the wholesaler’s end-customer, who is covered under a contract with the
manufacturer allowing it to purchase at a lower price, pays for a product. Although we establish reserves based on our prior experience and our best estimates of
the impact that these policies may have in subsequent periods, we cannot ensure that our reserves are adequate or that actual product returns, rebates, allowances
and chargebacks will not exceed our estimates.
Certain of our products use controlled substances, the availability of which may be limited by the DEA and other regulatory agencies.
We utilize controlled substances in certain of our current products and products in development and therefore must meet the requirements of the
Controlled Substances Act of 1970 and the related regulations administered by the DEA in the United States. These laws relate to the manufacture, shipment,
storage, sale and use of controlled substances. The DEA and other regulatory agencies limit the availability of the active ingredients used in certain of our current
products and products in development and, as a result, our procurement quota of these active ingredients may not be sufficient to meet commercial demand or
complete clinical trials. We must annually apply to the DEA for procurement quota in order to obtain these substances. Any delay or refusal by the DEA in
establishing our procurement quota for controlled substances could delay or stop our clinical trials or product launches, or could cause trade inventory disruptions
for those products that have already been launched, which could have a material adverse effect on our business, results of operations and financial condition.
Unstable economic conditions may adversely affect our industry, business, results of operations and financial condition.
The global economy has undergone a period of significant volatility which has led to diminished credit availability, declines in consumer confidence and
increases in unemployment rates. There remains caution about the stability of the U.S. economy, and we cannot assure that further deterioration in the financial
markets will not occur. These economic conditions have resulted in, and could lead to further, reduced consumer spending related to healthcare in general and
pharmaceutical products in particular.
In addition, we have exposure to many different industries and counterparties, including our partners under our alliance and collaboration agreements,
suppliers of raw chemical materials, drug wholesalers and other customers that may be affected by an unstable economic environment. Any economic instability
may affect these parties’ ability to fulfill their respective contractual
33
obligations to us, cause them to limit or place burdensome conditions upon future transactions with us or drive us and our competitors to decrease prices, each of
which could materially and adversely affect our business, results of operations and financial condition.
Furthermore, the capital and credit markets have experienced extreme volatility. Disruptions in the credit markets make it harder and more expensive to
obtain funding. In the event current resources do not satisfy our needs, we may have to seek additional financing. The availability of additional financing will
depend on a variety of factors such as market conditions and the general availability of credit. Future debt financing may not be available to us when required or
may not be available on acceptable terms, and as a result we may be unable to grow our business, take advantage of business opportunities, or respond to
competitive pressures.
We may be subject to disruptions or failures in our information technology systems and network infrastructures that could have a material adverse effect on
our business.
We rely on the efficient and uninterrupted operation of complex information technology systems and network infrastructures to operate our business. We
also hold data in various data center facilities upon which our business depends. A disruption, infiltration or failure of our information technology systems or any
of our data centers as a result of software or hardware malfunctions, system implementations or upgrades, computer viruses, third-party security breaches,
employee error, theft or misuse, malfeasance, power disruptions, natural disasters or accidents could cause breaches of data security, loss of intellectual property
and critical data and the release and misappropriation of sensitive competitive information. Any of these events could result in the loss of key information, impair
our production and supply chain processes, harm our competitive position, cause us to incur significant costs to remedy any damages and ultimately materially and
adversely affect our business, results of operations and financial condition.
While we have implemented a number of protective measures, including firewalls, antivirus, patches, data encryption, log monitors, routine back-ups with
offsite retention of storage media, system audits, data partitioning, routine password modifications and disaster recovery procedures, such measures may not be
adequate or implemented properly to prevent or fully address the adverse effect of such events.
We may be adversely affected by alliance, collaboration, supply, or license and distribution agreements we enter into with other companies.
We have entered into several alliance, collaboration, supply or license and distribution agreements with respect to certain of our products and services and
may enter into similar agreements in the future. These arrangements may require us to relinquish rights to certain of our technologies or product candidates, or to
grant licenses on terms that ultimately may prove to be unfavorable to us. Relationships with alliance partners may also include risks due to regulatory
requirements, incomplete marketplace information, inventories, and commercial strategies of our partners, and our agreements may be the subject of contractual
disputes. If we or our partners are not successful in commercializing the products covered by the agreements, such commercial failure could adversely affect our
business.
Pursuant to license and distribution agreements with unrelated third party pharmaceutical companies, we are dependent on such companies to supply us
with product that we market and sell, and we may enter into similar agreements in the future. Any delay or interruption in the supply of product under such
agreements could curtail or delay our product shipment and adversely affect our revenues, as well as jeopardize our relationships with our customers.
From time to time we may need to rely on licenses to proprietary technologies, which may be difficult or expensive to obtain.
We may need to obtain licenses to patents and other proprietary rights held by third parties to develop, manufacture and market products. If we are unable
to timely obtain these licenses on commercially reasonable terms, our ability to commercially market our products may be inhibited or prevented, which could
have a material adverse effect on our business, results of operations and financial condition.
We depend on qualified scientific and technical employees and are increasingly dependent on our direct sales force, and our limited resources may make it
more difficult to attract and retain these personnel.
Because of the specialized scientific nature of our business, we are highly dependent upon our ability to continue to attract and retain qualified scientific
and technical personnel. We are not aware of any pending, significant losses of scientific or technical personnel. Loss of the services of, or failure to recruit, key
scientific and technical personnel, however, would be significantly detrimental to our product-development programs. As a result of our small size and limited
financial and other resources, it may be difficult for us to attract and retain qualified officers and qualified scientific and technical personnel.
34
In addition, marketing of our branded products, such as the Zomig® products pursuant to our AZ Agreement with AstraZeneca and Rytary ® , requires
much greater use of a direct sales force compared to marketing of our generic products. Our ability to realize significant revenues from marketing and sales
activities depends on our ability to attract and retain qualified sales personnel. Competition for qualified sales personnel is intense. Any failure to attract or retain
qualified sales personnel could negatively impact our sales revenue and have a material adverse effect on our business, results of operations and financial
condition.
Other than our Interim President and Chief Executive Officer who was appointed in December 2016 by our board, we have entered into employment
agreements with our executive officers and certain other key employees that provide that the executive officer may terminate his or her employment upon 60 days
prior written notice to us. Our letter agreement with our Interim President and Chief Executive Officer provides that he may terminate his employment upon
reasonable notice to our board. All of our other key personnel are employed on an at-will basis with no formal employment agreements. We do not maintain “Key
Man” life insurance on any executives.
We are subject to significant costs and uncertainties related to compliance with the extensive regulations that govern the manufacturing, labeling, distribution,
promotion and sale of pharmaceutical products as well as environmental, safety and health regulations.
The manufacturing, distribution, processing, formulation, packaging, labeling, promotion and sale of our products are subject to extensive regulation by
federal agencies, including the FDA, DEA, FTC, Consumer Product Safety Commission and Environmental Protection Agency, among others. We are also subject
to state and local laws, regulations and agencies in California, New Jersey, Pennsylvania and elsewhere, as well as the laws and regulations of Taiwan. Such
regulations are also subject to change by the relevant federal, state and international agencies. For instance, beginning from January 1, 2015, we have been
required to comply with certain requirements under the Drug Quality and Security Act (“DQSA”), specifically Title II of the DQSA, referred to as the Drug Supply
Chain Security Act, which requires companies in certain prescription drugs’ chain of distribution to build electronic, interoperable systems to identify and trace the
products as they are distributed in the United States. Compliance with the Drug Supply Chain Security Act has resulted in increased expenses for us and has
imposed greater administrative burdens on our organization. Compliance with further requirements of the DQSA or any future federal or state electronic pedigree
requirements may result in further expenditures.
As further described above under the risk factor, “ Manufacturing or quality control problems may damage our reputation for quality production, demand
costly remedial activities and negatively impact our business, results of operations and consolidated financial condition” , we are required to comply with the
requirements of the FDA and our products are required to be manufactured in a manner consistent with cGMP and other similar standards. If we, or one of our
third party suppliers, fail to comply with the FDA requirements and other applicable laws and regulations, we may breach our representations made to our
customers or the FDA or other governmental may take action against us or our products, which could have a material adverse effect on our business, results of
operations and financial condition.
The FDA may also require labeling revisions, formulation or manufacturing changes and/or product modifications or additional safety data for our new or
existing products. If the FDA imposes more stringent requirements or requires any additional safety, testing or remedial measures on our products or product
candidates, we could incur increased costs for, or delays in, obtaining approval of such products or be required to remove such products from the market. For
instance, the drug safety and risk management advisory committee and the anesthetic and analgesic drug products advisory committee of the FDA have announced
a joint meeting in March 2017 to discuss safety issues related to Endo Pharmaceutical Inc.’s new drug application for Opana® ER (oxymorphone hydrochloride)
extended release tablets, which is an approved formulation intended to have abuse-deterred properties, and pre and post-marketing data about the abuse of the
product. The FDA has announced that the committees will also discuss the abuse of generic oxymorphone hydrochloride ER products at the meeting. We are
unable to predict the outcome from the committee meeting and whether the FDA will subsequently impose more stringent requirements on, or require removal of,
our generic oxymorphone hydrochloride ER product from the market as a result of the meetings, any of which could have a material adverse effect on our business,
results of operations and financial condition.
With respect to environmental, safety and health laws and regulations, we cannot accurately predict the outcome or timing of future expenditures that we
may be required to make in order to comply with such laws as they apply to our operations and facilities. We are also subject to potential liability for the
remediation of contamination associated with both present and past hazardous waste generation, handling, and disposal activities. We are subject periodically to
environmental compliance reviews by environmental, safety, and health regulatory agencies. Environmental laws are subject to change and we may become
subject to stricter environmental standards in the future and face larger capital expenditures in order to comply with environmental laws.
35
Compliance with federal and state and local law regulations, including compliance with any newly enacted regulations, requires substantial expenditures
of time, money and effort to ensure full technical compliance. Failure to comply with applicable governmental regulations can result in fines, disgorgement,
unanticipated compliance expenditures, recall or seizure of products, exposure to product liability claims, total or partial suspension of production or distribution,
suspension of the FDA’s review of NDAs or ANDAs, enforcement actions, injunctions and civil or criminal prosecution, any of which could have a material and
adverse effect on our business, results of operations and financial condition.
We may experience reductions in the levels of reimbursement for pharmaceutical products by governmental authorities, HMOs or other third-party payers.
Any such reductions could have a material adverse effect on our business, results of operations and financial condition.
Various governmental authorities and private health insurers and other organizations, such as HMOs, provide reimbursement to consumers for the cost of
certain pharmaceutical products. Demand for our products depends in part on the extent to which such reimbursement is available. In addition, third-party payers
are attempting to control costs by limiting the level of reimbursement for medical products, including pharmaceuticals, and increasingly challenge the pricing of
these products which may adversely affect the pricing of our products. Moreover, health care reform has been, and is expected to continue to be, an area of national
and state focus, which could result in the adoption of measures that could adversely affect the pricing of pharmaceuticals or the amount of reimbursement available
from third-party payers for our products.
Reporting and payment obligations under the Medicaid rebate program and other government programs are complex, and failure to comply could result in
sanctions and penalties or we could be required to reimburse the government for underpayments, which could have a material adverse effect on our business.
Medicaid and other government reporting and payment obligations are highly complex and somewhat ambiguous. State attorneys general and the U.S.
Department of Justice have brought suits or instituted investigations against a number of other pharmaceutical companies for failure to comply with Medicaid and
other government reporting obligations. Our methodologies for making these calculations are complex and the judgments involved require us to make subjective
decisions, such that these calculations are subject to the risk of errors. Government agencies may impose civil or criminal sanctions, including fines, penalties and
possible exclusion from federal health care programs, including Medicaid and Medicare. Any such penalties or sanctions could have a material adverse effect on
our business, results of operations and financial condition.
Legislative or regulatory programs that may influence prices of prescription drugs could have a material adverse effect on our business.
Current or future federal or state laws and regulations may influence the prices of drugs and, therefore, could adversely affect the prices that we receive
for our products. Programs in existence in certain states seek to set prices of all drugs sold within those states through the regulation and administration of the sale
of prescription drugs. Expansion of these programs, in particular, state Medicaid programs, or changes required in the way in which Medicaid rebates are
calculated under such programs, could adversely affect the price we receive for our products and could have a material adverse effect on our business, results of
operations and financial condition. Further, as described in detail above under the risk factor “ Our business is highly dependent on market perceptions of us and
the safety and quality of our products. Our business, products or pricing could be subject to negative publicity, which could have a material adverse effect on our
business, results of operations and financial condition” pharmaceutical product prices have been the focus of increased scrutiny by the government, including
certain state attorneys general, members of congress and the United States Department of Justice. Decreases in health care reimbursements or prices of our
prescription drugs could limit our ability to sell our products or decrease our revenues, which could have a material adverse effect on our business, results of
operations and financial condition.
Our failure to comply with the legal and regulatory requirements governing sales, marketing and pricing of our products may result in substantial fines,
sanctions and restrictions on our business activities.
Our practices and activities related to the sales and marketing of our products, as well as the pricing of our products, are subject to extensive regulation
under U.S. federal and state healthcare statutes and regulations intended to combat fraud and abuse to federal and state healthcare payment programs, such as
Medicare and Medicaid, Tri-Care, CHAMPUS, and Department of Defense programs. These laws include the federal Anti-Kickback Statute, the federal False
Claims Act, and similar state laws and implementing regulations. For example, the payment of any incentive to a healthcare provider to induce the
recommendation of our product or the purchase of our products reimbursable under a federal or state program is prohibited under these laws. Likewise, knowingly
presenting or causing to be presented a false claim for payment to a federal or state health care program would expose a company to sanctions and penalties.
Similarly, the inaccurate reporting of prices leading to inflated reimbursement rates would also be considered a violation of these laws. The Physician Payment
Sunshine Act enacted in 2010 imposes reporting and disclosure
36
requirements on drug manufacturers for any “transfer of value” made or distributed to prescribers and other healthcare providers. Failure to submit this required
information may result in significant civil monetary penalties. These laws and regulations are enforced by the U.S. Department of Justice, the U.S. Department of
Health and Human Services, Office of Inspector General, state Medicaid Fraud Units and other state enforcement agencies.
Violations of the laws and regulations described above are punishable by criminal and civil sanctions, including substantial fines and penal sanctions,
such as imprisonment. It is common for enforcement agencies to initiate investigations into sales and marketing practices, as well as pricing practices, regardless of
merit. These types of investigations and any related litigation can result in: (i) large expenditures of cash for legal fees, payment for penalties, and compliance
activities; (ii) limitations on operations; (iii) diversion of management resources; (iv) injury to our reputation; and (v) decreased demand for our products.
While we have developed corporate compliance programs based on what we believe to be current best practices, we cannot assure you that we or our
employees or agents are or will be in compliance with all applicable federal or state regulations and laws. Further, the criteria for determining compliance are often
complex and subject to change and interpretation. If we are in violation of any of these requirements or any such actions are instituted against us, and we are not
successful in defending ourselves or asserting our rights, those actions could include the imposition of significant criminal and civil fines and penalties, exclusion
from federal healthcare programs or other sanctions, any which could have a material and adverse effect on our business, results of operations and financial
condition.
We have entered into, and anticipate entering into, contracts with various U.S. government agencies. Unfavorable provisions in government contracts, some of
which may be customary, may harm our business, results of operations and financial condition.
Government contracts customarily contain provisions that give the government substantial rights and remedies, many of which are not typically found in
commercial contracts, including provisions that allow the government to:
•
•
•
•
•
•
•
•
•
suspend or debar the contractor from doing business with the government or a specific government agency;
terminate existing contracts, in whole or in part, for any reason or no reason;
reduce the scope and value of contracts;
change certain terms and conditions in contracts;
claim rights to products, including intellectual property, developed under the contract;
take actions that result in a longer development timeline than expected;
direct the course of a development program in a manner not chosen by the government contractor;
audit and object to the contractor’s contract-related costs and fees, including allocated indirect costs; and
control and potentially prohibit the export of the contractor’s products.
Generally, government contracts contain provisions permitting unilateral termination or modification, in whole or in part, at the government’s
convenience. Under general principles of government contracting law, if the government terminates a contract for convenience, the terminated company may
recover only its incurred or committed costs, settlement expenses and profit on work completed prior to the termination.
If the government terminates a contract for default, the defaulting company is entitled to recover costs incurred and associated profits on accepted items
only and may be liable for excess costs incurred by the government in procuring undelivered items from another source. Some government contracts grant the
government the right to use, for or on behalf of the U.S. government, any technologies developed by the contractor under the government contract. If we were to
develop technology under a contract with such a provision, we might not be able to prohibit third parties, including our competitors, from using that technology in
providing products and services to the government.
As a government contractor, we may also become subject to periodic audits and reviews. As part of any such audit or review, the government may review
the adequacy of, and our compliance with, our internal control systems and policies, including those relating to our purchasing, property, compensation and/or
management information systems. In addition, if an audit or review uncovers any improper or illegal activity, we may be subject to civil and criminal penalties and
administrative sanctions, including termination of our contracts, forfeiture of profits, suspension of payments, fines and suspension or prohibition from doing
business with the government. We could also suffer serious harm to our reputation if allegations of impropriety were made against us.
37
Legislative or regulatory reform of the healthcare system in the United States may harm our future business.
In recent years, there have been numerous initiatives on the federal and state levels for comprehensive reforms affecting the payment for, the availability
of and reimbursement for, healthcare services in the United States, and it is likely that Congress and state legislatures and health agencies will continue to focus on
healthcare reform in the future. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, collectively
commonly referred to as the “Healthcare Reform Act” became effective on January 1, 2010 and amongst other changes, increased the minimum Medicaid drug
rebates for pharmaceutical companies and revised the definition of “average manufacturer price” for reporting purposes, which affected the amount of our
Medicaid drug rebates to states and imposed a significant annual fee on companies that manufacture or import branded prescription drug products.
We are unable to predict the future course of federal or state healthcare legislation. If significant additional reforms are made to the United States
healthcare system, those reforms could have a material adverse effect on our business, results of operations and financial condition.
We depend on our intellectual property, and our future success is dependent on our ability to protect our intellectual property and not infringe on the rights of
others.
We believe intellectual property protection is important to our business and that our future success will depend, in part, on our ability to obtain patent
protection, maintain trade secret protection and operate without infringing on the rights of others. We cannot assure you that:
•
•
•
any of our future processes or products will be patentable;
our processes or products will not infringe upon the patents of third parties; or
we will have the resources to defend against charges of patent infringement by third parties or to protect our own rights against infringement by third
parties.
We rely on trade secrets and proprietary knowledge related to our products and technology which we generally seek to protect by confidentiality and non-
disclosure agreements with employees, consultants, licensees and pharmaceutical companies. If these agreements are breached, we may not have adequate
remedies for any breach, and our trade secrets may otherwise become known by our competitors.
We are subject to potential product liability claims that can result in substantial litigation costs and liability.
The design, development and manufacture of pharmaceutical products involve an inherent risk of product liability claims and associated adverse
publicity. Product liability insurance coverage is expensive, difficult to obtain, and may not be available in the future on acceptable terms, or at all. Although we
currently carry $50.0 million of such insurance, we believe that no reasonable amount of insurance can fully protect against all such risks because of the potential
liability inherent in the business of producing pharmaceutical products for human consumption.
Changes in tax regulations and varying application and interpretations of these regulations could result in an increase in our existing and future tax
liabilities.
We have potential tax exposures resulting from the varying application of statutes, regulations and interpretations, including exposures with respect to
manufacturing, research and development, marketing, sales and distribution functions. Although our arrangements are based on accepted tax standards, tax
authorities in various jurisdictions including the United States may disagree with and subsequently challenge the amount of profits taxed, which may increase our
tax liabilities and could have a material adverse effect on our business, results of our operations and financial condition.
There are inherent uncertainties involved in estimates, judgments and assumptions used in the preparation of financial statements in accordance with GAAP.
Any future changes in estimates, judgments and assumptions used or necessary revisions to prior estimates, judgments or assumptions could lead to a
restatement of our results.
The consolidated financial statements included in this Annual Report on Form 10-K are prepared in accordance with GAAP. This involves making
estimates, judgments and assumptions that affect reported amounts of assets (including intangible assets), liabilities, revenues, expenses and income. Estimates,
judgments and assumptions are inherently subject to change in the future and any necessary revisions to prior estimates, judgments or assumptions could lead to a
restatement. Any such changes could result in corresponding changes to the amounts of assets (including goodwill and other intangible assets), liabilities, revenues,
expenses and income.
38
If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results, timely file
our periodic reports, maintain our reporting status or prevent fraud.
Our management or our independent registered public accounting firm may identify material weaknesses in our internal control over financial reporting in
the future. The existence of internal control material weaknesses may result in current and potential stockholders and alliance and collaboration agreements’
partners losing confidence in our financial reporting, which could harm our business, the market price of our common stock, and our ability to retain our current, or
obtain new, alliance and collaboration agreements’ partners.
In addition, the existence of material weaknesses in our internal control over financial reporting may affect our ability to timely file periodic reports under
the Exchange Act. Although we remedied any past accounting issues and do not believe similar accounting problems are likely to recur, an internal control material
weakness may develop in the future and affect our ability to timely file our periodic reports. The inability to timely file periodic reports under the Exchange Act
could result in the SEC revoking the registration of our common stock, which would prohibit us from listing or having our stock quoted on any public market. This
would have an adverse effect on our business and stock price by limiting the publicly available information regarding us and greatly reducing the ability of our
stockholders to sell or trade our common stock.
Terrorist attacks and other acts of violence or war may adversely affect our business.
Terrorist attacks at or nearby our facilities in Hayward, California, Middlesex, New Jersey, or our manufacturing facility in Taiwan may negatively affect
our operations. While we do not believe that we are more susceptible to such attacks than other companies, such attacks could directly affect our physical facilities
or those of our suppliers or customers and could make the transportation of our products more difficult and more expensive and ultimately affect our sales.
We carry insurance coverage on our facilities of types and in amounts that we believe are in line with coverage customarily obtained by owners of similar
properties. We continue to monitor the state of the insurance market in general and the scope and cost of coverage for acts of terrorism in particular, but we cannot
anticipate what coverage will be available on commercially reasonable terms in future policy years. Currently, we carry terrorism insurance as part of our property
and casualty and business interruption coverage. If we experience a loss that is uninsured or that exceeds policy limits, we could lose the capital invested in the
damaged facilities, as well as the anticipated future net sales from those facilities.
Because of the location of our manufacturing and research and development facilities, our operations could be interrupted by an earthquake or be susceptible
to climate changes.
Our corporate headquarters in California, manufacturing operations in California and Taiwan, and research and development activities related to process
technologies are located near major earthquake fault lines. Although we have other facilities, we produce a substantial portion of our products at our California
facility. A disruption at these California facilities due to an earthquake, other natural disaster, or due to climate changes, even on a short-term basis, could impair
our ability to produce and ship products to the market on a timely basis. In addition, we could experience a destruction of facilities which would be costly to
rebuild, or loss of life, all of which could materially adversely affect our business and results of operations.
We presently carry $75.0 million, $20.0 million, and $25.0 million of earthquake coverage related to our facilities and property (including inventory)
located in Hayward, California, Taiwan, R.O.C., and Memphis, TN, respectively. For all other worldwide locations where we have facilities and/or property, we
presently carry $100.0 million of earthquake coverage. We believe the aggregate amount of earthquake coverage we currently carry is appropriate in light of the
risks; however, the amount of our earthquake insurance coverage may not be sufficient to cover losses from earthquakes. We may discontinue some or all of this
insurance coverage in the future if the cost of premiums exceeds the value of the coverage discounted for the risk of loss. If we experience a loss that is uninsured
or that exceeds policy limits, we could lose the capital invested in the damaged facilities, as well as the anticipated future net sales from those facilities.
39
The expansion of social media platforms present new risks and challenges, which could cause a material adverse effect on our business, results of operations
and financial condition.
The inappropriate use of certain media vehicles could cause brand damage or information leakage or could lead to legal implications from the improper
collection and/or dissemination of personally identifiable information. In addition, negative posts or comments about us on any social networking website could
seriously damage our reputation. Further, the disclosure of non-public company sensitive information through external media channels could lead to information
loss as there might not be structured processes in place to secure and protect information. If our non-public sensitive information is disclosed or if our reputation is
seriously damaged through social media, it could have a material adverse effect on our business, results of operations and financial condition.
Item 1B. Unresolved Staff Comments
Not applicable.
40
Item 2. Properties
Our primary properties consist of various owned and leased facilities in California, Pennsylvania and New Jersey as well as a significant manufacturing
facility that we own in Taiwan. The expiration dates of the lease agreements range between January 14, 2017 and August 30, 2027. Our properties are generally
used to support the operations of both the Impax Generics division and the Impax Specialty Pharma division. The table below shows the square feet owned or
leased by function at each location.
Location
Hayward, CA
Hayward, CA
Hayward, CA
Hayward, CA
Hayward, CA
Hayward, CA
Hayward, CA
Hayward, CA
California Properties
Fort Washington, PA
Horsham, PA
Pennsylvania Properties
Middlesex, NJ
Middlesex, NJ
Middlesex, NJ
Middlesex, NJ
Bridgewater, NJ
New Jersey Properties
Taiwan
Totals
Owned
Leased
Total
Function
35,000
50,000
19,000
50,400
13,300
—
—
—
167,700
—
—
—
—
—
—
—
—
—
397,917
565,617
—
—
—
—
—
76,180
45,000
88,677
209,857
46,000
6,341
52,341
37,500
18,593
20,651
32,516
32,806
142,066
—
404,264
35,000 Research & development
50,000 Manufacturing
19,000 Administration & lab
50,400 Warehouse
13,300 Manufacturing support
76,180 Warehouse & lab
45,000 Corporate offices
88,677 Manufacturing & lab
377,557
46,000 Administration
6,341 Administration
52,341
37,500 Manufacturing
18,593 Packaging
20,651 Research & development
32,516 Administration
32,806 Administration
142,066
397,917 Manufacturing *
969,881
* This facility is on land that is leased from the state.
In our various facilities we maintain an extensive equipment base that includes new or recently reconditioned equipment for the manufacturing and
packaging of compressed tablets, coated tablets and capsules. The manufacturing and research and development equipment includes mixers and blenders for
capsules and tablets, automated capsule fillers, tablet presses, particle reduction, sifting equipment, and tablet coaters. The packaging equipment includes fillers,
cottoners, cappers, and labelers. We also maintain two well equipped, modern laboratories used to perform all the required physical and chemical testing of our
products. We also maintain a broad variety of material handling and cleaning, maintenance, and support equipment. We own substantially all of our manufacturing
equipment and believe it is well maintained and suitable for its requirements.
We maintain property and casualty and business interruption insurance in amounts we believe are sufficient and consistent with practices for companies
of comparable size and business.
Item 3. Legal Proceedings
Information pertaining to legal proceedings can be found in “Item 15. Exhibits and Financial Statement Schedules – Note 22. Legal and Regulatory
Matters” and is incorporated by reference herein.
Item 4. Mine Safety Disclosures
Not applicable.
41
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Stock Price
PART II.
Our common stock is traded on the NASDAQ Global Market under the symbol "IPXL". The following table sets forth the high and low sales prices for
our common stock as reported by the NASDAQ Global Market, as follows:
Year Ended December 31, 2016
First Quarter
Second Quarter
Third Quarter
Fourth Quarter
Year Ended December 31, 2015
First Quarter
Second Quarter
Third Quarter
Fourth Quarter
Price Range
per Share
High
Low
43.16 $
37.20 $
32.20 $
24.47 $
47.70 $
52.10 $
51.42 $
45.00 $
29.66
27.62
20.97
12.28
29.76
42.25
31.85
31.83
$
$
$
$
$
$
$
$
This performance graph shall not be deemed "soliciting material" or to be "filed" with the Securities and Exchange Commission for purposes of Section
18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities under that Section, and shall not be deemed to
be incorporated by reference into any filing of Impax Laboratories, Inc. under the Securities Act of 1933, as amended, or the Exchange Act.
42
Holders
As of December 31, 2016 , there were approximately 217 holders of record of our common stock, solely based upon the count our transfer agent provided
us as of that date.
Dividends
We have never paid cash dividends on our common stock and have no present plans to do so. Our current policy is to retain all earnings, if any, for use in
the operation of our business. The payment of future cash dividends, if any, will be at the discretion of our Board of Directors and will be dependent upon our
earnings, financial condition, capital requirements and other factors as our Board of Directors may deem relevant.
Unregistered Sales of Securities
There were no sales of unregistered securities during the year ended December 31, 2016 .
Purchases of Equity Securities by the Issuer
The following table provides information regarding the purchases of our equity securities by us during the quarter ended December 31, 2016 .
Period
Total Number of
Shares (or Units)
Purchased(1)
Average Price
Paid Per Share
(or Unit)
October 1, 2016 to October 31, 2016
120,385 $
21.64
November 1, 2016 to November 30, 2016
—
—
December 1, 2016 to December 31, 2016
56,020 $
25.96
Total
176,405 $
23.01
Total
Number of
Shares (or
Units)
Purchased
as Part of
Publicly
Announced
Plans or
Programs
Maximum
Number
(or Approximate
Dollar Value) of
Shares (or Units)
that May Yet Be
Purchased Under
the Plans or
Programs
—
—
—
—
—
—
—
—
(1) Represents shares of our common stock that were repurchased to settle employee tax withholding obligations upon the vesting of shares of restricted stock
and/or exercise of stock options pursuant to the terms of our Third Amended and Restated 2002 Equity Incentive Plan (the “2002 Plan”).
43
Equity Compensation Plans
The following table details information regarding our existing equity compensation plans as of December 31, 2016 :
Number of
Securities to be
Issued Upon
Exercise of
Outstanding
Options, Warrants
and Rights
Weighted Average
Exercise Price of
Outstanding
Options, Warrants
and Rights
Number of
Securities
Remaining
Available for
Future Issuance
Under Equity
Compensation
Plans (Excluding
Securities reflected
in
Column (a))
Plan Category
(a)
(b)
(c)
Equity compensation plans approved by security holders
Equity compensation plans not approved by security holders
Total:
2,234,331 (1)
—
2,234,331
$
$
22.67
—
22.67
1,688,034
51,638 (2)
1,739,672
(1) Represents options issued pursuant to the 2002 Plan and the Impax Laboratories, Inc. 1999 Equity Incentive Plan.
(2) Represents 51,638 shares of common stock available for future issuance under the Impax Laboratories, Inc. 2001 Non-Qualified Employee Stock
Purchase Plan.
See “Item 15. Exhibits and Financial Statement Schedules — Note 17. Employee Benefit Plans” and “Note 16. Share-Based Compensation” for
information concerning our employee benefit plans and equity compensation plans.
44
Item 6. Selected Financial Data
The following selected financial data should be read together with our consolidated financial statements and accompanying consolidated financial
statement footnotes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” appearing elsewhere in this Annual Report on
Form 10-K. The selected consolidated financial statement data in this section are not intended to replace our consolidated financial statements and the
accompanying consolidated financial statement footnotes. Our historical consolidated financial results are not necessarily indicative of our future consolidated
financial results.
The selected financial data set forth below are derived from our consolidated financial statements. The consolidated statements of operations data for the
years ended December 31, 2016 , 2015 and 2014 and the consolidated balance sheet data as of December 31, 2016 and 2015 are derived from our audited
consolidated financial statements included elsewhere in this Annual Report on Form 10-K. These audited consolidated financial statements include, in the opinion
of management, all adjustments necessary for the fair presentation of our financial position and results of operations for these periods.
(In thousands, except per share data)
Statements of Operations Data:
Total revenues
Research and development
Total operating expenses
(Loss) income from operations
Net (loss) income
Net (loss) income per share — basic
Net (loss) income per share — diluted
(In thousands)
Balance Sheet Data:
Cash, cash equivalents and short-term investments
Working capital
Total assets
Long-term debt
Total liabilities
Retained earnings
Total stockholders’ equity
$
$
$
$
Years Ended December 31,
2016
2015
2014
2013
2012
824,429 $
860,469 $
596,049 $
511,502 $
80,466
343,080
(494,182)
(472,031)
(6.63) $
(6.63) $
70,622
282,836
69,568
38,997
0.56 $
0.54 $
78,642
223,837
88,816
57,353
0.84 $
0.81 $
68,854
205,687
(6,387)
101,259
1.51 $
1.47 $
581,692
81,320
199,562
82,992
55,873
0.85
0.82
As of December 31,
2016
2015
2014
2013
2012
180,133 $
340,351 $
414,856 $
413,133 $
309,817
495,312
516,927
1,823,018
1,922,487
1,079,197
813,545
1,199,044
98,192
623,974
424,595
860,078
570,223
1,062,409
—
191,320
531,226
887,877
505,852
996,923
—
186,720
473,873
810,203
298,918
400,248
863,970
—
172,867
372,614
691,103
45
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis, as well as other sections in this report, should be read in conjunction with the consolidated financial statements and
related Notes to Consolidated Financial Statements included elsewhere herein. All references to years mean the relevant 12-month period ended December 31.
Overview
We are a specialty pharmaceutical company applying formulation and development expertise, as well as our drug delivery technology, to the
development, manufacture and marketing of bioequivalent pharmaceutical products, commonly referred to as “generics,” in addition to the development,
manufacture and marketing of branded products. We operate in two segments, referred to as “Impax Generics” and “Impax Specialty Pharma.” Impax Generics
concentrates its efforts on generic products, which are the pharmaceutical and therapeutic equivalents of brand-name drug products and are usually marketed under
their established nonproprietary drug names rather than by a brand name. Impax Specialty Pharma utilizes its specialty sales force to market proprietary branded
pharmaceutical products for the treatment of CNS disorders and other select specialty segments. Impax Specialty Pharma also generated revenue from research and
development services provided to an unrelated third-party pharmaceutical entity (which agreement was terminated by mutual agreement of the parties effective
December 23, 2015). We sell our Impax Generics division products within the continental United States and the Commonwealth of Puerto Rico. We have no sales
in foreign countries.
We plan to continue to expand Impax Generics through targeted ANDAs and a first-to-file and first-to-market strategy and to continue to evaluate and
pursue external growth initiatives, including acquisitions and partnerships. We focus our efforts on a broad range of therapeutic areas including products that have
technically challenging drug-delivery mechanisms or unique product formulations. We employ our technologies and formulation expertise to develop generic
products that reproduce brand-name products’ physiological characteristics but do not infringe any valid patents relating to such brand-name products. We
generally focus our generic product development on brand-name products as to which the patents covering the active pharmaceutical ingredient have expired or are
near expiration, and we employ our proprietary formulation expertise to develop controlled-release technologies that do not infringe patents covering the brand-
name products’ controlled-release technologies. We also develop, manufacture, sell and distribute specialty generic pharmaceuticals that we believe present one or
more competitive advantages, such as difficulty in raw materials sourcing, complex formulation or development characteristics or special handling requirements.
In addition to our focus on solid oral dosage products, we have expanded our generic pharmaceutical products portfolio to include alternative dosage form
products, primarily through alliance and collaboration agreements with third parties. As of December 31, 2016 , we marketed 207 generic pharmaceuticals, which
represent dosage variations of 72 different pharmaceutical compounds through our Impax Generics division; another five of our generic pharmaceuticals
representing dosage variations of two different pharmaceutical compounds are marketed by our alliance and collaboration agreement partners. As of December 31,
2016 , in our Impax Generics Division, we had 25 applications pending at the FDA and 26 other products in various stages of development for which applications
have not yet been filed.
46
The Impax Generics division develops, manufactures, sells, and distributes generic pharmaceutical products primarily through the following sales
channels:
•
•
•
•
the “Impax Generics sales channel” for sales of generic prescription products we sell directly to wholesalers, large retail drug chains, and others;
the “Private Label Product sales channel” for generic pharmaceutical over-the-counter and prescription products we sell to unrelated third-party
customers who in-turn sell the product to third parties under their own label;
the “Rx Partner sales channel” for generic prescription products sold through unrelated third-party pharmaceutical entities under their own label
pursuant to alliance agreements; and
the “OTC Partner sales channel” for sales of generic pharmaceutical over-the-counter products sold through unrelated third-party pharmaceutical
entities under their own label pursuant to alliance agreements.
Revenues from the Impax Generics sales channel and the Private Label Product sales channel are reported under the caption “Impax Generics sales, net”
in our consolidated statements of operations.
Impax Specialty Pharma is engaged in the development, sale and distribution of proprietary branded pharmaceutical products that we believe represent
improvements to already-approved pharmaceutical products addressing CNS disorders, including migraine, multiple sclerosis, Parkinson's disease and post-
herpetic neuralgia, and other select specialty segments. We believe that we have the research, development and formulation expertise to develop branded products
that will deliver significant improvements over existing therapies.
Our branded pharmaceutical product portfolio consists of commercial CNS and other select specialty products, as well as development stage projects. In
February 2012, we licensed from AZ the exclusive U.S. commercial rights to Zomig® (zolmitriptan) tablet, orally disintegrating tablet and nasal spray
formulations pursuant to the terms of the AZ Agreement (which was subsequently amended) and began sales of the Zomig® products under our label during the
year ended December 31, 2012 through our specialty sales force. In May 2013, our exclusivity period for branded Zomig® tablets and orally disintegrating tablets
expired and we launched authorized generic versions of those products in the United States. In June 2015, the FDA approved the Zomig® nasal spray for use in
pediatric patients 12 years of age or older for the acute treatment of migraine with or without aura. In addition to the Zomig® products and our internally
developed pharmaceutical product, Rytary® for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon
monoxide intoxication and/or manganese intoxication, which was approved by the FDA on January 7, 2015, we are currently engaged in the sales and marketing of
Emverm® (mebendazole) 100 mg chewable tablets, indicated for the treatment of pinworm, whipworm, common roundworm, common hookworm, and two other
products, all acquired in our acquisition of Tower and Lineage which closed in March 2015. In November 2015, the European Commission granted marketing
authorization for Numient® (referred to as Rytary® in the United States). The review of the Numient® application was conducted under the centralized licensing
procedure as a therapeutic innovation, and the authorization is applicable in all 28 member states of the European Union, as well as Iceland, Liechtenstein and
Norway.
We have entered into several alliance, collaboration or license and distribution agreements with respect to certain of our products and services and may
enter into similar agreements in the future. These agreements may require us to relinquish rights to certain of our technologies or product candidates, or to grant
licenses on terms which ultimately may prove to be unfavorable to us. Relationships with alliance and collaboration partners may also include risks due to the
failure of a partner to perform under the agreement, incomplete marketplace information, inventories, development capabilities, regulatory compliance and
commercial strategies of our partners and our agreements may be the subject of contractual disputes. For instance, we have historically experienced some
disruptions in supply of certain products. If we suffer similar supply failures on our significant products in the future, or if we or our partners are not successful in
commercializing the products covered by such alliance, collaboration or license and distribution agreements, our revenues and relationships with our customers
may be materially adversely affected.
47
Critical Accounting Policies and Use of Estimates
The preparation of our consolidated financial statements in accordance with accounting principles generally accepted in the United States (“GAAP”) and
the rules and regulations of the U.S. Securities & Exchange Commission (“SEC”) require the use of estimates and assumptions, based on complex judgments
considered reasonable, and affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the
consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. The most significant judgments are employed in
estimates used in determining values of tangible and intangible assets, contingent consideration, legal contingencies, tax assets and tax liabilities, fair value of
share-based compensation related to equity incentive awards issued to employees and directors, and estimates used in applying our revenue recognition policy
including those related to accrued chargebacks, rebates, distribution service fees, product returns, Medicare, Medicaid, and other government rebate programs,
shelf-stock adjustments, and the timing and amount of deferred and recognized revenue under our several alliance and collaboration agreements. Actual results
may differ from estimated results. Certain prior year amounts have been reclassified to conform to the presentation for the year ended December 31, 2016 .
Although we believe our estimates and assumptions are reasonable when made, they are based upon information available to us at the time they are made.
We periodically review the factors having an influence on our estimates and, if necessary, adjust such estimates. Due to the risks and uncertainties involved in our
business and evolving market conditions, and given the subjective element of the estimates made, actual results may differ from estimated results. This possibility
may be greater than normal during times of pronounced economic volatility.
Impax Generics sales, net, and Impax Specialty Pharma sales, net. We recognize revenue from the sale of products when title and risk of loss of the
product is transferred to the customer and the sales price is fixed and determinable. Provisions for discounts, early payments, rebates, sales returns and distributor
chargebacks under terms customary in the industry are provided for in the same period the related sales are recorded. We record estimated reductions to revenue at
the time of the initial sale and these estimates are based on the sales terms, historical experience and trend analysis.
Gross to Net Sales Accruals
Sales returns accruals are based on using a historical lag period, which is the time between when the product is sold and when it is ultimately returned,
and estimated return rates which may be adjusted based on various assumptions including: changes to internal policies and procedures, business practices,
commercial terms with customers, and the competitive position of each product; the amount of inventory in the wholesale and retail supply chain; the introduction
of new products; and changes in market sales information. We also consider other factors, including significant market changes which may impact future expected
returns, and actual product returns. We allow our customers to return product if approved by authorized personnel in writing or by telephone with the lot number
and expiration date accompanying any request and if such products are returned within six months prior to or until twelve months following, the product’s
expiration date. We estimate and recognize an accrued provision for product returns as a percentage of gross sales based upon historical experience. Any changes
from the historical trend rates are considered in determining the current sales return allowance. If the historical data we use to calculate these estimates do not
properly reflect future returns, then a change in the allowance would be made in the period in which such a determination is made and revenues in that period could
be materially affected.
Cash discount accruals are based on payment terms extended to customers which are generally 2% to 3% of the gross selling price, as an incentive for
paying within invoice terms, which generally range from 30 to 90 days. An estimate of cash discounts is recorded in the same period when revenue is recognized
Government rebate accruals are based on estimated payments due to governmental agencies for purchases made by third parties under various
governmental programs. U.S. Medicaid rebate accruals are generally based on historical payment data and estimates of future Medicaid beneficiary utilization
applied to the Medicaid unit rebate formula established by the Center for Medicaid and Medicare Services. The accrual of the rebates associated with Medicaid
Managed Care Organizations is calculated based on actual billings received from the states. We adjust the rebate accruals as more information becomes available
and to reflect actual claims experience. Effective January 1, 2011, manufacturers of pharmaceutical products are responsible for 50% of the patient’s cost of
branded prescription drugs related to the Medicare Part D Coverage Gap. In order to estimate the cost to us of this coverage gap responsibility, we analyze the
historical invoices. This expense is recognized throughout the year as costs are incurred. TRICARE is a health care program of the U.S. Department of Defense
Military Health System that provides civilian health benefits for military personnel, military retirees and their dependents. TRICARE rebate accruals are based on
estimated Department of Defense eligible sales multiplied by the TRICARE rebate formula.
48
Rebates and administrative fees are offered to certain customers, group purchasing organizations and pharmacy benefit managers, consistent with
pharmaceutical industry practices. Settlement of rebates and fees may generally occur from one to 15 months from the date of sale. We provide a provision for
rebates and administrative fees at the time of sale based on contracted rates and historical redemption rates. Assumptions used to establish the provision include
level of customer inventories, contract sales mix and average contract pricing. We regularly review the information related to these estimates and adjust the
provision accordingly.
Chargeback accruals are based on the differentials between product acquisition prices paid by wholesalers and lower contract pricing paid by eligible
customers.
Distribution service fee accruals are based on contractual fees to be paid to the wholesale distributor for services provided.
A significant majority of our gross to net accruals are the result of chargebacks and rebates and administrative fees, with the majority of those programs
having an accrual to payment cycle of three months. In addition to this relatively short accrual to payment cycle, we receive monthly information from the
wholesalers regarding their sales of our products and actual on hand inventory levels of our products. During the year ended December 31, 2016 , the three large
wholesalers account for 98% of our chargebacks and 78% of our indirect sales rebates. Consistent with the pharmaceutical industry, the accrual to payment cycle
for returns is longer and can take several years depending on the expiration of the related products. However, returns represent the smallest gross to net adjustment.
We have not experienced any significant changes in our estimates as it relates to our chargebacks, rebates or returns in each of the years in the three-year period
ended December 31, 2016 .
The following tables are roll-forwards of the activity in the reserves for the years ended December 31, 2016 , 2015 and 2014 with an explanation for any
significant changes in the accrual percentages (in thousands):
Chargeback reserve
Beginning balance
Acquired balances
Provision recorded during the period
Credits issued during the period
Ending balance
Provision as a percent of gross product sales
$
$
Years Ended December 31,
2016
2015
2014
102,630
$
—
1,014,108
(962,052)
154,686
$
36%
43,125
$
24,532
833,157
(798,184)
102,630
$
34%
37,066
—
487,377
(481,318)
43,125
35%
As noted in the table above, the provision for chargebacks, as a percent of gross product sales, increased to 36% in 2016 from 34% in 2015 primarily as a
result of product sales mix and inclusion of product sales from the Tower Acquisition and Teva Transaction. The aggregate provision for chargebacks, as a percent
of gross product sales, decreased to 34% in 2015 from 35% in 2014 primarily as a result of product sales mix and inclusion of product sales from the Tower
Acquisition.
Rebate reserve
Beginning balance
Acquired balances
Provision recorded during the period
Credits issued during the period
Ending balance
Provision as a percent of gross product sales
Years Ended December 31,
2016
2015
2014
$
$
265,229
$
—
752,613
(733,211)
284,631
$
27%
88,812
$
75,447
571,642
(470,672)
265,229
$
23%
88,449
—
260,747
(260,384)
88,812
19%
As noted in the table above, the provision for rebates, as a percent of gross product sales, increased from 23% during the year ended December 31, 2015
to 27% during the year ended December 31, 2016 as a result of product sales mix, the formation of alliances between certain major wholesalers and major retailers
and the inclusion of product sales from the Tower Acquisition which carry a higher rebate rate.
49
The provision for rebates, as a percent of gross product sales, increased from 19% during the year ended December 31, 2014 to 23% during the year
ended December 31, 2015 as a result of product sales mix, the formation of alliances between certain major wholesalers and major retailers and the inclusion of
product sales from the Tower Acquisition which carry a higher rebate rate.
The table above represents rebates in both the Impax Generics and Impax Specialty Pharma divisions. The payment mechanisms for rebates in the Impax
Generics and Impax Specialty Pharma divisions are different, which impacts the location on our balance sheet. Only rebates in the Impax Generics division are
shown in "Item 15. Exhibits and Financial Statement Schedules - Notes to Consolidated Financial Statements - Note 8. Accounts Receivable," as Impax Specialty
Pharma rebates are classified as Accrued Expenses on our consolidated balance sheets.
Returns reserve
Beginning balance
Acquired balances
Provision related to sales recorded in the period
Credits issued during the period
Ending balance
Provision as a percent of gross product sales
$
$
Years Ended December 31,
2016
2015
2014
48,950
$
—
52,383
(28,445)
72,888
$
1.9%
27,174
$
11,364
43,967
(33,555)
48,950
$
2.0%
28,089
—
12,016
(12,931)
27,174
1.0%
As noted in the table above, the provision for returns as a percent of gross product sales decreased to 1.9% in 2016 compared to 2.0% in 2015 as a result
of slightly lower historical returns experience.
The provision for returns as a percent of gross product sales increased to 2.0% in 2015 compared to 1.0% in 2014 as a result of the Tower Acquisition
whose products carry a higher historical returns experience, higher than anticipated returns volume resulting from the loss of exclusivity on certain Zomig®
products and higher returns accruals due to price increases on certain generic products.
Medicaid and Other Government Pricing Programs. As required by law, we provide a rebate payment on drugs dispensed under the Medicaid, Medicare
Part D, TRICARE, and other U.S. government pricing programs. We determine our estimate of the accrued rebate reserve for government programs primarily
based on historical experience of claims submitted by the various states, and other jurisdictions, as well as any new information regarding changes in the pricing
programs that may impact our estimate of rebates. In determining the appropriate accrual amount, we consider historical payment rates and processing lag for
outstanding claims and payments. We record estimates for government rebate payments as a deduction from gross sales, with corresponding adjustments to
accrued liabilities. The accrual for payments under government pricing programs totaled $72.1 million, $91.7 million, and $18.3 million as of December 31, 2016 ,
December 31, 2015 and December 31, 2014 , respectively.
Shelf-Stock Adjustments. Based upon competitive market conditions, we may reduce the selling price of some of our products to customers for certain
future product shipments. We may issue a credit against the sales amount to a customer based upon its remaining inventory of the product in question, provided the
customer agrees to continue to make future purchases of product from us. This type of customer credit is referred to as a shelf-stock adjustment, which is the
difference between the sales price and the revised lower sales price, multiplied by an estimate of the number of product units on hand at a given date. Decreases in
selling prices are discretionary decisions made by us in response to market conditions, including estimated launch dates of competing products and estimated
declines in market price. The accrued reserve for shelf-stock adjustments totaled $7.0 million, $6.6 million, and $1.9 million as of December 31, 2016 ,
December 31, 2015 and December 31, 2014 , respectively.
50
Rx Partner and OTC Partner. Each of our Rx Partner and OTC Partner agreements contain multiple deliverables in the form of products, services and/or
licenses over extended periods. FASB ASC Topic 605-25 supplemented SAB 104 and provides guidance for accounting for such multiple-element revenue
arrangements. With respect to our multiple-element revenue arrangements that are material to our financial results, we determine whether any or all of the elements
of the arrangement should be separated into individual units of accounting under FASB ASC Topic 605-25. If separation into individual units of accounting is
appropriate, we recognize revenue for each deliverable when the revenue recognition criteria specified by SAB 104 are achieved for the deliverable. If separation is
not appropriate, we recognize revenue and related direct manufacturing costs over the estimated life of the agreement or our estimated expected period of
performance using either the straight-line method or a modified proportional performance method.
The Rx Partners and OTC Partners agreements obligate us to deliver multiple goods and/or services over extended periods. Such deliverables include
manufactured pharmaceutical products, exclusive and semi-exclusive marketing rights, distribution licenses, and research and development services. In exchange
for these deliverables, we receive payments from our agreement partners for product shipments and research and development services, and may also receive other
payments including royalty, profit sharing, upfront payments, and periodic milestone payments. Revenue received from our partners for product shipments under
these agreements is generally not subject to deductions for chargebacks, rebates, product returns, and other pricing adjustments. Royalty and profit sharing amounts
we receive under these agreements are calculated by the respective agreement partner, with such royalty and profit share amounts generally based upon estimates
of net product sales or gross profit which include estimates of deductions for chargebacks, rebates, product returns, and other adjustments the alliance agreement
partners may negotiate with their customers. We record the agreement partner's adjustments to such estimated amounts in the period the agreement partner reports
the amounts to us.
OTC Partner revenue is related to our alliance and collaboration agreement with Pfizer, Inc., formerly Wyeth LLC (“Pfizer”) and our supply agreement
with L. Perrigo Company (“Perrigo”) with respect to the supply of over-the-counter pharmaceutical product Loratadine and Pseudoephedrine Sulfate 5 mg/120 mg
12-hour Extended Release Tablets (the "D12 Product"). The OTC Partner sales channel is no longer a core area of our business, and the over-the-counter
pharmaceutical products we sell through this sales channel are older products which are only sold to Pfizer and Perrigo. We recognize profit share revenue in the
period earned.
During the quarter ended September 30, 2016, we sold the ANDAs for both the D12 Product and Loratadine and Pseudoephedrine Sulfate 10 mg/240 mg
24-hour Extended Release Tablets, in addition to other specified assets, to Perrigo pursuant to an asset purchase agreement with Perrigo dated as of March 31, 2016
(the "Perrigo APA"). Under the terms of the Perrigo APA, we will also continue to supply the D-12 Product to Pfizer and Perrigo until the date that is the earliest
of (i) the date that Perrigo's manufacturing facility is approved to manufacture the D-12 Product and (ii) December 31, 2017 (the "Supply End Date"). On the
Supply End Date, we will assign and transfer our supply agreement with Pfizer in its entirety to Perrigo in accordance with the Perrigo APA.
Research Partner . We have entered into development agreements with unrelated third-party pharmaceutical companies under which we are collaborating
in the development of five dermatological products, including four generic products and one branded dermatological product. Under each of the development
agreements, we received an upfront fee with the potential to receive additional milestone payments upon completion of contractually specified clinical and
regulatory milestones. Additionally, we may also receive royalty payments from the sale, if any, of a successfully developed and commercialized branded product
under one of the development agreements. We defer and recognize revenue received from the achievement of contingent research and development milestones in
the period such payment is earned. We will recognize royalty fee income, if any, as current period revenue when earned.
Estimated Lives of Alliance and Collaboration Agreements. Because we may defer revenue we receive under our alliance agreements, and recognize it
over the estimated life of the related agreement, or our expected period of performance, we are required to estimate the recognition period under each such
agreement in order to determine the amount of revenue to be recognized in each period. Sometimes this estimate is based on the fixed term of the particular
alliance agreement. In other cases the estimate may be based on more subjective factors as noted in the following paragraphs. While changes to the estimated
recognition periods have been infrequent, such changes, should they occur, may have a significant impact on our consolidated financial statements.
51
As an illustration, the consideration received from the provision of research and development services under the Joint Development Agreement with
Valeant Pharmaceuticals International, Inc. (“Valeant Agreement”), including the upfront fee and milestone payments received before January 1, 2011, have been
initially deferred and are being recognized as revenue on a straight-line basis over our expected period of performance to provide research and development
services under the Valeant Agreement. The completion of the final deliverable under the Valeant Agreement represents the end of our estimated expected period of
performance, as we will have no further contractual obligation to perform research and development services under the Valeant Agreement, and therefore the
earnings process will be complete. The expected period of performance was initially estimated to be a 48 month period, starting in December 2008, upon receipt of
the $40.0 million upfront payment, and ending in November 2012. During the year ended December 31, 2012, we extended the end of the revenue recognition
period for the Valeant Agreement from November 2012 to November 2013 and during the three month period ended March 31, 2013, we further extended the end
of the revenue recognition period for the agreement from November 2013 to December 2014 due to changes in the estimated timing of completion of certain
research and development activities under the agreement. All deferred revenue under the Valeant Agreement was completely recognized as of December 31, 2014.
Third-Party Research Agreements. In addition to our own research and development resources, we may use unrelated third-party vendors, including
universities and independent research companies, to assist in our research and development activities. These vendors provide a range of research and development
services to us, including clinical and bio-equivalency studies. We generally sign agreements with these vendors which establish the terms of each study performed
by them, including, among other things, the technical specifications of the study, the payment schedule, and timing of work to be performed. Third-party
researchers generally earn payments either upon the achievement of a milestone, or on a pre-determined date, as specified in each study agreement. We account for
third-party research and development expenses as they are incurred according to the terms and conditions of the respective agreement for each study performed,
with an accrued expense at each balance sheet date for estimated fees and charges incurred by us, but not yet billed to us. We monitor aggregate actual payments
and compare them to the estimated provisions to assess the reasonableness of the accrued expense balance at each quarterly balance sheet date.
Share-Based Compensation. We recognize the grant date fair value of each option and restricted share over its vesting period. Stock options and restricted
stock awards granted under the 2002 Plan generally vest over a four year period and, in the case of stock options, have a term of ten years. We estimate the fair
value of each stock option award on the grant date using the Black-Scholes-Merton option-pricing model, wherein expected volatility is based on historical
volatility of our common stock. We base the expected term calculation on the “simplified” method described in SAB No. 107, Share-Based Payment and SAB No.
110, Share-Based Payment, because it provides a reasonable estimate in comparison to our actual experience. We base the risk-free interest rate on the U.S.
Treasury yield in effect at the time of grant for an instrument with a maturity that is commensurate with the expected term of the stock options. The dividend yield
is zero as we have never paid cash dividends on our common stock, and have no present intention to pay cash dividends. During the year ended December 31,
2014, we granted shares of restricted stock that vested upon the achievement of certain stock price performance criteria. We valued these awards using a Monte
Carlo simulation.
Income Taxes. We are subject to U.S. federal, state and local income taxes, Netherlands income tax, Republic of Ireland income tax and Taiwan R.O.C.
income taxes.
Significant management judgment is required in determining the provision for income taxes, deferred tax assets and liabilities, and any valuation
allowance recorded against net deferred tax assets. The process involves summarizing temporary differences between the financial statement carrying values (in
accordance with U.S. GAAP) and the tax bases of our assets and liabilities. These differences result in a net deferred tax asset or liability, which is included within
the consolidated balance sheet. In addition, we are required to assess whether valuation allowances should be established against our deferred tax assets based on
consideration of all available evidence using a "more likely than not" standard. To the extent a valuation allowance is established in a period, an expense must
generally be recorded within the income tax provision in the statement of operations.
In assessing the realizability of our deferred tax assets, we consider whether it is more likely than not that our deferred tax assets will be realized based
upon all available evidence, including, but not limited to, scheduled reversal of deferred tax liabilities, prior earnings history, projected future earnings, carryback
and carryforward periods and the feasibility of ongoing tax strategies that could potentially enhance the likelihood of the realization of a deferred tax asset. The
weight we afford the evidence is commensurate with the extent the evidence may be objectively verified. As such, we did not rely on or project future taxable
income (exclusive of reversing taxable temporary differences and carryforwards) to outweigh objective negative evidence of a recent financial reporting loss for
the year ended December 31, 2016.
52
In relying on the objectively verifiable negative evidence of the three-year cumulative loss, and in not considering or projecting taxable income under the
provisions of FASB ASC Topic 740, “Income Taxes,” we confined our sources of income to realize the deferred tax assets to (1) carryback to recover taxes paid in
the current year or prior years and (2) offsetting taxable amounts related to taxable temporary differences within the carryback or carryforward period for which
deferred tax liabilities are more likely than not to be realized. The deferred tax liabilities consist of indefinite-lived acquired IPR&D product rights.
Our consolidated net deferred tax asset valuation allowance totaled $108.8 million as of December 31, 2016, such that we realize on a more likely than
not basis, a tax-effected net deferred tax asset of $69.9 million. If actual results differ from these estimates or these estimates are adjusted in future periods, the
valuation allowance may need to be adjusted, which could materially impact our financial position and results of operations. If sufficient positive evidence arises in
the future indicating that all or a portion of the deferred tax assets meet the more likely than not standard for realization, the valuation allowance would be reduced
accordingly in the period that such a conclusion is reached.
We recognize the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are
measured at the largest amount that is greater than 50% likely of being realized. We reevaluate the effect of uncertain income tax positions on a quarterly basis, and
any changes in recognition or measurement are reflected in the period in which the change in judgment occurs. This evaluation is based on factors including, but
not limited to, changes in facts and circumstances, changes in tax law, effectively settled issues, and new audit activity. Any changes in these factors could result in
changes to a tax benefit or tax provision.
Fair Value of Financial Instruments. We carry our deferred compensation liability at the value of the amount owed to participants, and derive it from
observable market data by reference to hypothetical investments. The carrying values of other financial assets and liabilities such as cash equivalents, accounts
receivable, prepaid and other current assets, and accounts payable approximate their fair values due to their short-term nature.
Contingencies. In the normal course of business, we are subject to loss contingencies, such as legal proceedings and claims arising out of our business,
covering a wide range of matters, including, among others, patent litigation, stockholder lawsuits, and product and clinical trial liability. In accordance with FASB
ASC Topic 450, "Contingencies," we record accrued loss contingencies when it is probable a liability will be incurred and the amount of loss can be reasonably
estimated. We do not recognize gain contingencies until they have been realized.
Intangible Assets. Our intangible assets include both finite lived and indefinite-lived assets. Finite lived intangible assets, consisting of marketed product
rights and royalties received from product sales by our third party partners, are amortized over the estimated useful life of the asset based on the pattern in which
the economic benefits are expected to be consumed or otherwise used up or, if that pattern is not readily determinable, on a straight-line basis. Indefinite-lived
intangible assets consist of acquired in-process research and development (IPR&D) product rights and acquired future royalty rights to be paid based on other
companies’ net sales of products not yet approved. IPR&D assets acquired in a business combination are considered indefinite-lived until the completion or
abandonment of the associated research and development efforts. Amortization over the estimated useful life will commence at the time of the respective product’s
launch. If FDA approval to market the product is not obtained, we will immediately expense the related capitalized cost.
Finite lived intangible assets are tested for impairment when events or changes in circumstances indicate that the carrying value of the asset may not be
recoverable. All of our indefinite-lived intangible assets are tested for impairment at least annually during the fourth quarter of the fiscal year, or more often if
indicators of impairment are present. Impairment testing requires management to estimate the future undiscounted cash flows of an intangible asset using
assumptions believed to be reasonable, but which are unpredictable and inherently uncertain. Actual future cash flows may differ from the estimates used in the
impairment testing. We recognize an impairment loss when and to the extent that the estimated fair value of an intangible asset is less than its carrying value.
Goodwill . In accordance with FASB ASC Topic 350, "Goodwill and Other Intangibles," rather than recording periodic amortization of goodwill,
goodwill is subject to an annual assessment for impairment. Under FASB ASC Topic 350, if the fair value of the reporting unit exceeds the reporting unit’s
carrying value, including goodwill, then goodwill is considered not impaired, making further analysis not required. We consider each of our Impax Generics
division and Impax Specialty Pharma division operating segments to be a reporting unit, as this is the lowest level for each of which discrete financial information
is available. We attribute $59.7 million of goodwill to the Impax Specialty Pharma division and $147.6 million of goodwill to the Impax Generics division.
53
We concluded the carrying value of goodwill was not impaired as of December 31, 2016 and 2015 , as the fair value of the Impax Specialty Pharma
division and the Impax Generics division exceeded their respective carrying values at each date. We perform our annual goodwill impairment test in the fourth
quarter of each year. We estimate the fair value of the Impax Specialty Pharma division and the Impax Generics division using a discounted cash flow model for
both the reporting unit and the enterprise, as well as earnings and revenue multiples per common share outstanding for enterprise fair value. In addition, on a
quarterly basis, we perform a review of our business operations to determine whether events or changes in circumstances have occurred that could have a material
adverse effect on the estimated fair value of each reporting unit, and thus indicate a potential impairment of the goodwill carrying value. If such events or changes
in circumstances were deemed to have occurred, we would perform an interim impairment analysis, which may include the preparation of a discounted cash flow
model, or consultation with one or more valuation specialists, to analyze the impact, if any, on our assessment of the reporting unit’s fair value.
Results of Operations
Year Ended December 31, 2016 Compared to Year Ended December 31, 2015
Overview
The following table sets forth our summarized, consolidated results of operations for the years ended December 31, 2016 and 2015 (in thousands):
Total revenues
Gross (loss) profit
(Loss) income from operations
(Loss) income before income taxes
(Benefit from) provision for income taxes
Net (loss) income
* Percentage exceeds 100%
Year Ended December 31,
Increase / (Decrease)
2016
2015
Dollars
Percentage
$
$
824,429 $
(151,102)
(494,182)
(576,325)
(104,294)
860,469 $
352,404
69,568
59,368
20,371
(472,031) $
38,997 $
(36,040)
(503,506)
(563,750)
(635,693)
(124,665)
(511,028)
(4)%
*
*
*
*
*
Consolidated total revenues for the year ended December 31, 2016 decreased by 4%, or $36.1 million, to $824.4 million compared to $860.5 million for
the year ended December 31, 2015. The decrease was primarily attributable to lower Impax Generics division product sales, partially offset by higher Impax
Specialty Pharma division product sales. Selling price for existing products decreased consolidated total revenues by 16.3%, while volumes for existing products
increased consolidated total revenues by 2.7%, in each case compared to the prior year. New product launches, including those resulting from acquisitions,
increased consolidated total revenues by 9.4% compared to the prior year.
Revenues from our Impax Generics division decreased by $104.6 million during the year ended December 31, 2016, as compared to the prior year. This
decrease was primarily due to lower selling prices across a majority of the products in the division, partially offset by higher sales volumes, including those
resulting from product acquisitions. The products that experienced significant declines in selling price during the year ended December 31, 2016 compared to the
prior year included diclofenac sodium gel, metaxalone, generic Adderall XR®, and fenofibrate family products. In connection with the pricing declines, we
recorded $15.0 million in shelf-stock adjustments related to diclofenac sodium gel and metaxalone during 2016. Partially offsetting these pricing declines were
price and volume increases of certain products compared to 2015 primarily related to our epinephrine auto-injector and oxymorphone products. We currently
expect pricing pressures on generic products to continue in the industry at least in the near term. We are closely monitoring these developments as they relate to our
products, customers, and end users.
Revenues from our Impax Specialty Pharma division increased by $68.6 million during the year ended December 31, 2016, as compared to the prior year.
The increase was primarily due to higher selling prices and higher sales volumes across a majority of the products in the division including Zomig®, Rytary®,
which launched in April 2015, and our anthelmintic products franchise.
54
Net loss for the year ended December 31, 2016 was $472.0 million, a decrease of $511.0 million compared to net income of $39.0 million for the year
ended December 31, 2015. The net loss for the year ended December 31, 2016 was primarily driven by $541.6 million in intangible asset impairment charges, as
compared to $13.7 million of such charges in the prior year, as well as a $40.3 million reserve recorded as a result of the uncertainty of collection of the receivable
due from Turing for reimbursement of Daraprim® chargebacks and Medicaid rebate liabilities. Included in our 2015 results was a $45.6 million gain related to the
sale of Daraprim® to Turing, for which there was no comparable gain in 2016. Refer to "Item 15. Financial Information - Notes to Consolidated Financial
Statements - Note 4. Summary of Significant Accounting Policies - Concentration of Credit Risk" for information related to the Daraprim® sale and Turing
reserve.
Of the $541.6 million in intangible asset impairment charges we incurred in 2016, $308.4 million of such charges related to certain intangible assets
acquired as part of the Teva Transaction. Upon closing the Teva Transaction on August 3, 2016, we initiated the process of transferring and securing Teva’s and
Allergan’s customers for the acquired products to our account. We assumed certain price concessions would occur following the closing. However, we elected to
take additional price reductions on certain of the acquired products in order to retain key customers. These reductions produced significantly lower than expected
operating cash flows from the acquired product lines and triggered an impairment charge of $251.0 million during the third quarter of 2016. We experienced even
further price reductions on certain of the products acquired in the Teva Transaction during the fourth quarter of 2016, which resulted in $57.4 million of additional
intangible asset impairment charges. In total, our impairment analyses for the products acquired in the Teva Transaction resulted in the recognition of $308.4
million of non-cash impairment charges to earnings, comprised of a $301.7 million charge recorded in cost of revenues impairment charges and a $6.7 million
charge recorded in-process research and development impairment charges in our consolidated statement of operations for the year ended December 31, 2016.
During 2016, we also incurred other non-cash impairment charges on certain of our intangible assets, primarily related to the products acquired from the
Tower Acquisition, totaling $233.2 million. These impairment charges arose primarily due to increased competition, price degradation, product discontinuations
and delays in expected product launches. The largest intangible asset impairment charge related to products acquired in the Tower Acquisition was for our
epinephrine auto-injector product, which occurred during the fourth quarter of 2016 and accounted for more than half of the $233.2 million in charges. The
impairment charge on the epinephrine auto-injector product was triggered by current and projected price degradation as a result of unexpected changes in the
pricing environment and additional competition.
55
Impax Generics
The following table sets forth results of operations for the Impax Generics division for the years ended December 31, 2016 and 2015 (in thousands):
Year Ended December 31,
Increase / (Decrease)
2016
2015
Dollars
Percentage
Revenues:
Impax Generics sales, net
$
591,744 $
699,844 $
(108,100)
Rx Partner
Other Revenues
Total revenues
Cost of revenues
Cost of revenues impairment charges
Gross (loss) profit
Operating expenses:
Selling, general and administrative
Research and development
In-process research and development impairment
charges
Patent litigation expense
Total operating expenses
(Loss) income from operations
* Percentage exceeds 100%
Revenues
14,339
237
606,320
417,316
464,319
(275,315)
20,508
61,980
27,765
829
111,082
9,307
1,781
710,932
442,742
7,303
260,887
29,641
52,478
6,360
2,942
91,421
5,032
(1,544)
(104,612)
(25,426)
457,016
(536,202)
(9,133)
9,502
21,405
(2,113)
19,661
$
(386,397) $
169,466 $
(555,863)
(15)%
54 %
(87)%
(15)%
(6)%
*
*
(31)%
18 %
*
(72)%
22 %
*
Total revenues for the Impax Generics division for the year ended December 31, 2016 were $606.3 million, a decrease of $104.6 million or 15%, over the
prior year. The decrease was primarily due to increased competition on diclofenac sodium gel, metaxalone, and fenofibrate, coupled with lower market share for
generic Adderall XR® during the first half of 2016, in each case compared to the prior year. These decreases were partially offset by increased sales of
oxymorphone, increased sales of epinephrine auto-injector, which was acquired as part of the Tower Acquisition in March 2015, and sales of the products acquired
as part of the Teva Transaction in August 2016, in each case compared to the prior year. In addition, during the year ended December 31, 2016, we recorded a
$15.0 million shelf-stock adjustment related to diclofenac sodium gel and metaxalone as a result of declining prices during 2016, for which there was no
comparable charge in the prior year.
Cost of Revenues
Cost of revenues was $417.3 million for the year ended December 31, 2016, a decrease of $25.4 million from the prior year. The decrease was primarily
attributable to lower costs related to decreased product revenue compared to the prior year and the absence of costs related to (i) the step-up to fair value of
inventory in connection with the Tower Acquisition, (ii) Hayward remediation activities and (iii) the Philadelphia restructuring, which were all incurred in the prior
year but for which we did not incur comparable costs in 2016. The reduced costs during 2016 compared to the prior year were partially offset by higher intangible
asset amortization expenses resulting from the Teva Transaction and a full year of amortization expense related to products acquired in the Tower Acquisition,
along with higher restructuring costs incurred in conjunction with the previously announced closure of the Middlesex, New Jersey facility.
56
Cost of Revenues Impairment Charges
Cost of revenues impairment charges was $464.3 million for the year ended December 31, 2016, a $457.0 million increase over the prior year. Of this
increase, $301.7 million related to impairments recognized on certain intangible assets acquired as part of the Teva Transaction. As discussed above, we assumed
certain price concessions would occur following the closing of the Teva Transaction on August 3, 2016. However, we elected to take additional price reductions on
certain of the acquired products in order to retain key customers. These reductions produced significantly lower than expected operating cash flows from the
acquired product lines and triggered an impairment charge of $248.0 million during the third quarter of 2016. We experienced even further price reductions on
certain of the products acquired in the Teva Transaction during the fourth quarter of 2016, which resulted in $53.7 million of additional intangible asset impairment
charges recorded in cost of revenues impairment charges.
During 2016, we also incurred other non-cash impairment charges recorded to cost of revenues impairment charges on certain of our intangible assets,
primarily related to the products acquired from the Tower Acquisition, totaling $162.6 million. These impairment charges arose primarily due to increased
competition, price degradation, and product discontinuations. The largest intangible asset impairment charge related to the products acquired in the Tower
Acquisition was on our epinephrine auto-injector product, which occurred during the fourth quarter of 2016. The impairment charge on the epinephrine auto-
injector product was triggered by current and projected price degradation as a result of changes in the pricing environment and additional competition.
Gross (Loss) Profit
Gross (loss) for the year ended December 31, 2016 was ($275.3) million, or 45% of total revenues, as compared to gross profit of $260.9 million, or 37%
of total revenues, for the prior year. The decreases in gross profit and gross margin were primarily due to intangible asset impairment charges, lower product sales,
higher shelf-stock adjustments, increased intangibles amortization, and increased restructuring costs, as noted above. These decreases were partially offset by the
absence of remediation costs related to the Hayward facility and the absence of restructuring costs related to the Philadelphia facility in 2016, both incurred in
2015.
Selling, General and Administrative Expenses
Selling, general, and administrative expenses for the year ended December 31, 2016 were $20.5 million, as compared to $29.6 million for the year ended
December 31, 2015. The $9.1 million decrease from the prior year was primarily attributable to a decrease in failure to supply claims during 2016.
Research and Development Expenses
Research and development expenses for the year ended December 31, 2016 were $62.0 million, as compared to $52.5 million for the year ended
December 31, 2015. The $9.5 million increase from the prior year was primarily due to an increase in external development costs from increased research and
development activities and a full year of research and development expenses from the Tower acquired companies.
In-process Research and Development Impairment Charges
In-process research and development impairment charges were $27.8 million for the year ended December 31, 2016, an increase of $21.4 million from the
prior year. The 2016 impairment charges included $21.1 million related to products acquired as part of the Tower Acquisition and caused primarily due to delays in
the expected start of commercialization and/or lower anticipated pricing of such products amid highly competitive market conditions, resulting in lower forecasted
future cash flows. There were $6.4 million of similar charges recorded in the prior year. In addition, the 2016 impairment charges included $6.7 million related to
products acquired as part of the Teva Transaction and caused by lower anticipated pricing amid highly competitive market conditions, resulting in lower forecasted
future cash flows.
Patent Litigation Expenses
Patent litigation expenses for the year ended December 31, 2016 were $0.8 million, as compared to $2.9 million for the year ended December 31, 2015.
The $2.1 million decrease was due to reduced legal activity in 2016 compared to the prior year.
57
Impax Specialty Pharma
The following table sets forth results of operations for the Impax Specialty Pharma division for the years ended December 31, 2016 and 2015 (in
thousands):
Revenues:
Year Ended December 31,
Increase / (Decrease)
2016
2015
Dollars
Percentage
Impax Specialty Pharma sales, net
$
218,109 $
145,226 $
Other Revenues
Total revenues
Cost of revenues
Cost of revenues impairment charges
Gross profit
Operating expenses:
Selling, general and administrative
Research and development
In-process research and development
impairment charges
Patent litigation expense
Total operating expenses
Income from operations
—
218,109
69,583
24,313
124,213
61,448
18,486
25,200
6,990
112,124
4,311
149,537
58,020
—
91,517
52,427
18,144
—
1,625
72,196
$
12,089 $
19,321 $
72,883
(4,311)
68,572
11,563
24,313
32,696
9,021
342
25,200
5,365
39,928
(7,232)
50 %
*
46 %
20 %
*
36 %
17 %
2 %
*
*
55 %
(37)%
* Percentage exceeds 100%
Revenues
Total revenues for the Impax Specialty Pharma division for the year ended December 31, 2016 were $218.1 million, an increase of $68.6 million or 46%
over the prior year. The increase was primarily due to increased sales from Rytary®, which we launched in April 2015, and increased revenues resulting from the
Tower Acquisition, including sales from our anthelmintic products franchise.
Cost of Revenues
Cost of revenues was $69.6 million for the year ended December 31, 2016, an $11.6 million increase over the prior year. The increase was primarily due
to higher costs related to increased product sales and a full year of amortization expense related to products acquired in the Tower Acquisition. Additionally, cost
of revenues for the prior year included a $5.4 million step-up to fair value of inventory charge in connection with the Tower Acquisition, for which there was no
comparable charge in 2016.
Cost of Revenues Impairment Charges
Cost of revenues impairment charges were $24.3 million for the year ended December 31, 2016. There were no comparable charges during the prior year.
The impairment charge was primarily the result of lower than expected script volume for Emverm®.
Gross Profit
Gross profit for the year ended December 31, 2016 was $124.2 million, or 57% of total revenues, as compared to $91.5 million, or 61% of total revenues,
in the prior year. The increase in gross profit in 2016 compared to the prior year was primarily due to increased product sales and the absence in 2016 of the $5.4
million step-up to fair value of inventory charge in connection with the Tower Acquisition we incurred in 2015, partially offset by higher impairment charges
during 2016. The decrease in gross margin during the year ended December 31, 2016 was primarily due to lower selling prices on certain products compared to the
prior year.
58
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the year ended December 31, 2016 were $61.4 million, as compared to $52.4 million for the year ended
December 31, 2015. The $9.0 million increase during the year ended December 31, 2016 was primarily due to expenses related to the sales force expansion to
support sales and marketing activities for Rytary® and increased advertising and promotion expenses to support the launch of Emverm® and the new indication of
Zomig® nasal spray for pediatric patients approved by the FDA in June 2015. The increase in expenses during 2016 was partially offset by training expenses
incurred during the year ended December 31, 2015 to support the launch of Rytary®.
Research and Development Expenses
Research and development expenses for the year ended December 31, 2016 were $18.5 million, as compared to $18.1 million for the year ended
December 31, 2015. The $0.4 million increase compared to the prior year was primarily due to increased research and development activities related to our
branded initiatives.
In-process Research and Development Impairment Charges
In-process research and development impairment charges were $25.2 million for the year ended December 31, 2016. There were no comparable charges
during the prior year. The impairment charges resulted from management’s decision during the fourth quarter of 2016 to cease development on our next generation
Albenza® product due to continued difficulties in sourcing the active pharmaceutical ingredient for the product.
Patent Litigation Expenses
Patent litigation expenses for the year ended December 31, 2016 were $7.0 million, as compared to $1.6 million for the year ended December 31, 2015.
The $5.4 million increase during 2016 compared to the prior year was due to increased patent litigation activity in 2016.
59
Corporate and Other
The following table sets forth corporate general and administrative expenses, as well as other items of income and expense presented below income or
loss from operations for the years ended December 31, 2016 and 2015 (in thousands):
Year Ended December 31,
Increase / (Decrease)
2016
2015
Dollars
Percentage
119,874 $
(119,874)
(41,441)
1,022
(40,312)
—
—
—
(1,412)
(202,017)
(104,294) $
119,219 $
(119,219)
(27,268)
1,042
—
45,574
(16,903)
(13,000)
355
(129,419)
20,371 $
655
(655)
(14,173)
(20)
(40,312)
(45,574)
16,903
13,000
(1,767)
(72,598)
(124,665)
1 %
1 %
52 %
(2)%
*
*
*
*
*
56 %
*
General and administrative expenses
$
Unallocated corporate expenses
Interest expense
Interest income
Reserve for Turing receivable
Gain on sale of asset
Loss on debt extinguishment
Net change in fair value of derivatives
Other (expense) income, net
Loss before income taxes
(Benefit from) provision for income taxes
$
* Percentage exceeds 100%
General and Administrative Expenses
General and administrative expenses for the year ended December 31, 2016 were $119.9 million, as compared to $119.2 million for the year ended
December 31, 2015. The $0.7 million increase during 2016 compared to the prior year was primarily due to costs recognized in 2016 related to the separation of
our President and Chief Executive Officer from our company in December 2016 and higher legal expenses compared to the prior year, partially offset by lower
transaction and integration expenses related to strategic transactions during 2016 as compared to the transaction and integration expenses incurred related to the
Tower Acquisition during the prior year.
Interest Expense
Interest expense was $41.4 million for the year ended December 31, 2016, a $14.2 million increase from the prior year. Interest expense for 2016 reflected
interest on our $600.0 million convertible senior notes issued in 2015, interest on our $400.0 million Term Loan with Royal Bank of Canada entered into in 2016 to
fund the Teva Transaction, and unused line of credit fees on our Revolving Credit Facility with Royal Bank of Canada entered into in 2016. In contrast, prior year
interest expense of $27.3 million reflected interest expense on our Term Loan with Barclays Bank PLC entered into in connection with the financing of the Tower
Acquisition, which was repaid in full on June 30, 2016 using proceeds from the issuance of our $600.0 million senior notes. Refer to "Outstanding Debt
Obligations" below for additional information related to our outstanding convertible notes and credit facilities
Interest Income
Interest income was $1.0 million for the year ended December 31, 2016, which was relatively consistent with interest income for the year ended
December 31, 2015.
60
Reserve for Turing Receivable
During the year ended December 31, 2016, we recorded a reserve of $40.3 million, representing the amount of the estimated receivable due from Turing
for reimbursement of Daraprim® chargebacks and Medicaid rebate liabilities. We received $7.7 million in payments from Turing during the fourth quarter of
2016, which reduced the reserve balance of $48.0 million as of September 30, 2016 to the reserve balance of $40.3 million as of December 31, 2016. Refer to
“Item 15. Financial Information - Notes to the Consolidated Financial Statements - Note 4. Summary of Significant Accounting Policies - Concentration of Credit
Risk” for additional information related to the Turing receivable.
Gain on Sale of Asset
During the year ended December 31, 2015, we recognized a $45.6 million gain on the sale of our right to Daraprim®. There was no comparable gain in
2016.
Loss on Debt Extinguishment
During the year ended December 31, 2015, we recognized a $16.9 million loss on debt extinguishment related to the repayment of our $435.0 million
term loan with Barclays Bank PLC. There was no comparable loss in 2016.
Net Change in Fair Value of Derivatives
During the year ended December 31, 2015, we recognized a $13.0 million expense as the net change in the fair value of our derivative instruments entered
into in conjunction with our convertible senior notes due 2022. This expense resulted from the change in our stock price from June 30, 2015 to December 31, 2015.
A third party valuation firm with expertise in valuing financial instruments was engaged to determine the fair value of our bond hedge derivative asset and
conversion option derivative liability at each reporting period. There was no comparable change in the fair value of derivatives during 2016.
Other (Expense) Income, Net
Other expense, net was $1.4 million for the year ended December 31, 2016, a $1.8 million increase from the prior year. The increase was primarily due to
the change in the fair value of the contingent consideration due to Teva pursuant to the Termination Agreement with Teva whereby Teva returned to us our full
commercial rights to our pending ANDA for methylphenidate hydrochloride and due to an increase in fixed asset impairments over the prior year. Refer to "Item
15. Exhibits and Financial Statement Schedules - Note 2. Business Acquisitions" for more information on the Termination Agreement with Teva.
Income Taxes
During the year ended December 31, 2016, we recorded an aggregate tax benefit of $104.3 million for U.S. domestic income taxes and for foreign income
taxes, a decrease of $124.7 million compared to an aggregate tax provision of $20.4 million we recorded during the prior year. The decrease in the tax provision
during 2016 compared to the prior year resulted from lower income before taxes in the year ended December 31, 2016. The effective tax rate decreased to 18.1%
for the year ended December 31, 2016 compared to 34.3% for the year ended December 31, 2015.
The effective income tax rate was 18.1% for the fiscal year ended December 31, 2016, and reflected the establishment of a valuation allowance of $108.8
million against net deferred tax assets. Based on an evaluation of both the positive and negative evidence available, as discussed below, we determined that it was
necessary to establish a valuation allowance against a significant portion of our net deferred tax assets for the fiscal year ended December 31, 2016.
A valuation allowance, if needed, reduces deferred tax assets to the amount expected to be realized. When determining the amount of net deferred tax
assets that are more likely than not to be realized, we assess all available positive and negative evidence. This evidence includes, but is not limited to, scheduled
reversal of deferred tax liabilities, prior earnings history, projected future earnings, carry-back and carry-forward periods and the feasibility of ongoing tax
strategies that could potentially enhance the likelihood of the realization of a deferred tax asset. The weight given to the positive and negative evidence is
commensurate with the extent the evidence may be objectively verified. As such, it is generally difficult for positive evidence regarding projected future taxable
income (exclusive of reversing taxable temporary differences and carryforwards) to outweigh objective negative evidence of a recent financial reporting loss for
the year ended December 31, 2016.
61
Based on these criteria and the relative weighting of both the positive and negative evidence available, and in particular the activity surrounding our prior
earnings history, including the intangible impairments charges recognized during 2016, we determined that it was necessary to establish a valuation allowance
against a significant portion of our net deferred tax assets as of December 31, 2016. Given the objectively verifiable negative evidence of a three-year cumulative
loss which, under the provisions of FASB ASC Topic 740 is a significant element of negative evidence that is difficult to overcome, and the weighting of all
available positive evidence, we excluded projected taxable income from the assessment of income that could be used as a source of taxable income to realize the
deferred tax assets.
Year Ended December 31, 2015 Compared to Year Ended December 31, 2014
Overview
The following table sets forth our summarized, consolidated results of operations for the years ended December 31, 2015 and 2014 (in thousands):
Total revenues
Gross profit
Income from operations
Income before income taxes
Provision for income taxes
Net income
Year Ended December 31,
Increase / (Decrease)
2015
2014
Dollars
Percentage
$
860,469 $
596,049 $
264,420
352,404
312,653
69,568
59,368
20,371
88,816
90,559
33,206
$
38,997 $
57,353 $
39,751
(19,248)
(31,191)
(12,835)
(18,356)
44 %
13 %
(22)%
(34)%
(39)%
(32)%
Consolidated total revenues for the year ended December 31, 2015 increased by 44% or $264.5 million to $860.5 million, compared to $596.0 million
for the year ended December 31, 2014 . The increase in consolidated total revenues during 2015 was primarily due to the addition of product revenues from our
acquisition of Tower and increased sales of diclofenac sodium gel and the addition of sales from Rytary® and 14 generic products launched in 2015. The year-
over-year increase in revenue was partially offset by the absence of authorized generic Renvela® sales during 2015, for which there were sales during the prior
year. Product volumes (including from acquisitions) increased revenues by approximately 36.0%, while product selling price decreased revenues by approximately
4%, in each case compared to the prior year. New product launches increased revenues by approximately 12% compared to the prior year.
Revenues from our Impax Generics division increased by $161.9 million during 2015 , as compared to the prior year, driven primarily by the increase in
revenues from the Tower Acquisition and increased sales volume from diclofenac sodium gel, partially offset by the absence of sales of authorized generic
Renvela® during 2015, for which there were sales during the prior year. Revenues from the Impax Specialty Pharma division increased by $102.6 million during
2015 , as compared to the prior year, as a result of the launch of Rytary® as well as product volumes from the Tower acquired companies during 2015.
Net income for the year ended December 31, 2015 was $39.0 million, a decrease of $18.4 million as compared to $57.4 million for the year ended
December 31, 2014 . The decrease was primarily attributable to lower margins from product sales and higher operating expenses, in each case compared to the
prior year. We also experienced higher amortization and impairment charges related to intangible assets, higher severance costs related to the restructuring of our
packaging and distribution facilities announced on June 30, 2015 as well as costs related to the fair value of inventory resulting from the Tower Acquisition. Such
increased costs were partially offset by reduced Hayward facility remediation costs during 2015. In addition, we had a loss on debt extinguishment related to the
repayment of our term loan with Barclays, as well as higher interest expense related to the Barclays term loan and to our convertible notes and a net loss on the
change in the fair value of our derivatives in connection with the call spread overlay on our convertible notes, in each case during 2015 for which we did not have
similar charges during the prior year period. The decrease in net income during 2015 was partially offset by the gain of $45.6 million from the sale of our rights to
Daraprim® in 2015.
62
Impax Generics
The following table sets forth results of operations for the Impax Generics division for the years ended December 31, 2015 and 2014 (in thousands):
Revenues
Impax Generics sales, net
Rx Partner
Other Revenues
Total revenues
Cost of revenues
Gross profit
Operating expenses:
Selling, general and administrative
Research and development
Patent litigation
Total operating expenses
Income from operations
Revenues
Year Ended December 31,
Increase / (Decrease)
2015
2014
Dollars
Percentage
$
699,844 $
528,512 $
171,332
9,307
1,781
710,932
450,045
260,887
29,641
58,838
2,942
91,421
14,114
6,456
549,082
260,459
288,623
17,144
40,927
5,333
63,404
(4,807)
(4,675)
161,850
189,586
(27,736)
12,497
17,911
(2,391)
28,017
$
169,466 $
225,219 $
(55,753)
32 %
(34)%
(72)%
29 %
73 %
(10)%
73 %
44 %
(45)%
44 %
(25)%
Total revenues for the Impax Generics division for the year ended December 31, 2015 were $710.9 million, an increase of 29% from the same period in
2014 , principally resulting from the addition of product revenue from the Tower Acquisition as well as increased sales from diclofenac sodium gel and 14 generic
products launched during 2015 including Lamotrigine ODT, partially offset by the absence of revenues from sales of authorized generic Renvela® during 2015, for
which there were sales during the prior year.
Cost of Revenues
Cost of revenues was $450.0 million for the year ended December 31, 2015 , an increase of $189.5 million compared to cost of revenues of $260.5
million in the prior year. In addition to increased costs related to higher product sales, cost of revenues in the current period increased due to higher product
amortization, intangible asset impairment charges, costs related to the step-up to fair value of inventory in connection with the Tower Acquisition, as well as
closing and severance costs related to the restructuring of our packaging and distribution operations announced on June 30, 2015. This increase was partially offset
by lower remediation costs, as compared to the prior year.
Gross Profit
Gross profit for the year ended December 31, 2015 was $260.9 million, or 37% of total revenues, as compared to $288.6 million, or 53% of total
revenues, in the prior year. The decline in gross profit and gross margin was primarily driven by product mix. Sales during 2014 of authorized generic Renvela®, a
high margin product, for which we had no sales in 2015, were replaced by lower margin products from the Tower Acquisition and sales of diclofenac sodium gel
which carry a 50% profit share with our third party partner.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the year ended December 31, 2015 were $29.6 million, a 73% increase over the prior year. The increase
during 2015 from the prior year was primarily the result of an increase in accounts receivable reserves and an increase in penalties paid to customers for delays or
failures to supply product and the addition of the selling, general and administrative expenses from the Tower Acquisition that were partially offset by lower
personnel expense during 2015.
63
Research and Development Expenses
Total research and development expenses for the year ended December 31, 2015 were $58.8 million, an increase of 44%, as compared to the prior year.
Generic research and development expenses increased in 2015 compared to the prior year, primarily due to the addition of research and development projects from
the Tower Acquisition including intangible asset impairment charges of $6.4 million.
Patent Litigation Expenses
Patent litigation expenses for the year ended December 31, 2015 were $2.9 million, a decrease of 45%, as compared to the prior year. The decrease in
patent litigation expenses in 2015 of $2.4 million compared to the prior year was the result of legal activity related to several cases in the prior year for which there
was no corresponding activity in 2015.
Impax Specialty Pharma
The following table sets forth results of operations for the Impax Specialty Pharma division for the years ended December 31, 2015 and 2014 (in
thousands):
Revenues
Impax Product sales, net
Other Revenues
Total revenue
Cost of revenues
Gross profit
Operating expenses:
Selling, general and administrative
Research and development
Patent litigation
Total operating expenses
Income (loss) from operations
* Percentage exceeds 100%
Revenues
Year Ended December 31,
Increase / (Decrease)
2015
2014
Dollars
Percentage
$
145,226 $
45,938 $
4,311
149,537
58,020
91,517
52,427
18,144
1,625
72,196
1,029
46,967
22,937
24,030
43,307
37,715
472
81,494
$
19,321 $
(57,464) $
99,288
3,282
102,570
35,083
67,487
9,120
(19,571)
1,153
(9,298)
76,785
*
*
*
*
*
21 %
(52)%
*
(11)%
*
Total revenues for the Impax Specialty Pharma division were $149.5 million for the year ended December 31, 2015 , an increase of $102.6 million
compared to the year ended December 31, 2014 , due to revenues from the launch of Rytary® and revenues from the Tower Acquisition during 2015.
Cost of Revenues
Cost of revenues was $58.0 million for the year ended December 31, 2015 , an increase of $35.1 million over the prior year. In addition to increased costs
related to increased product sales, cost of revenues increased in 2015 due to higher amortization and costs related to the step-up to fair value of inventory, each
incurred in connection with the Tower Acquisition. This increase was partially offset by a reserve included in the cost of revenues during 2014 for pre-launch
inventory related to Rytary® as a result of a Complete Response Letter received in 2014, for which there were no similar amounts included in cost of revenues in
2015.
64
Gross Profit
Gross profit for the year ended December 31, 2015 was $91.5 million or 61% of total revenues, as compared to $24.0 million or 51% of total revenues in
the prior year. The revenue from Rytary® and revenue from the Tower Acquisition were the primary drivers of the increase in gross profit compared to the prior
year. This increase during 2015 was partially offset by a reserve included in the cost of revenues during 2014 for pre-launch inventory related to Rytary® as a
result of a Complete Response Letter received in 2014, for which there were no similar amounts included in cost of revenues in 2015.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were $52.4 million in the year ended December 31, 2015 , an increase of $9.1 million as compared to $43.3
million in the prior year. The increase was primarily driven by an increase in advertising and promotion expenses to support the launch of Rytary® and related
sales force expansion as well as selling expenses from the Tower Acquisition.
Research and Development Expenses
Total research and development expenses for the year ended December 31, 2015 were $18.1 million, a decrease of 52%, as compared to $37.7 million in
the prior year. The decrease was primarily driven by a reduction in research and development expenses related to our branded initiatives and decreased costs
related to reduced personnel compared to 2014 due to the restructuring and related reduction in workforce primarily in our research and development organization
during the quarter ended December 31, 2014. In addition, research and development expense during 2014 included a $2.0 million upfront fee paid to Durect under
an agreement to acquire the exclusive worldwide rights to develop and commercialize Durect’s investigational transdermal bupivacaine patch for the treatment of
pain associated with post-herpetic neuralgia, for which there was no comparable payment made in 2015.
Patent Litigation Expenses
Patent litigation expenses for the year ended December 31, 2015 were $1.6 million, an increase of $1.1 million compared to the prior year amount of $0.5
million. The increase was the result of legal activity related to several cases in 2015 for which there was no corresponding activity in the prior year.
Corporate and Other
The following table sets forth corporate general and administrative expenses, as well as other items of income and expense presented below income
from operations for the years ended December 31, 2015 and 2014 (in thousands):
General and administrative expenses
Unallocated corporate expenses
Interest expense
Interest income
Gain on sale of asset
Loss on debt extinguishment
Net change in fair value of derivatives
Other income, net
Loss before income taxes
Provision for income taxes
* Percentage exceeds 100%
Year Ended December 31,
Increase / (Decrease)
2015
2014
Dollars
Percentage
$
119,219 $
78,939 $
(119,219)
(78,939)
(27,268)
1,042
45,574
(16,903)
(13,000)
355
(43)
1,473
—
—
—
313
(129,419)
(77,196)
$
20,371 $
33,206 $
40,280
(40,280)
(27,225)
(431)
45,574
(16,903)
(13,000)
42
(52,223)
(12,835)
51 %
(51)%
*
(29)%
*
*
*
13 %
(68)%
(39)%
65
General and Administrative Expenses
General and administrative expenses for the year ended December 31, 2015 were $119.2 million, a $40.3 million increase, as compared to $78.9 million
in the prior period. The increase was principally driven by higher business development expenses, the majority of which was transaction and/or integration
activities related to the Tower Acquisition, the inclusion of general and administrative expenses from the Tower Acquisition, increased finance and information
technology expenses as well as higher equity based compensation, in each case compared to the prior year. The Tower-related general and administrative expenses
included $2.4 million in employee severance costs related to the acquisition.
Interest Expense
Interest expense in the year ended December 31, 2015 was $27.3 million, primarily related to interest expenses on debt issued in connection with the
Tower Acquisition as well as interest accrued on our outstanding convertible notes which were issued in 2015 and for which we did not incur similar expense
during the prior year. Interest expense in 2015 also included $2.3 million in commitment fees incurred prior to the closing of the Tower Acquisition, for which
there were no corresponding fees in the prior year.
Interest Income
Interest income in the year ended December 31, 2015 was $1.0 million, a slight decrease from 2014.
Gain on Sale of Asset
During the year ended December 31, 2015 , we recognized a gain of $45.6 million on the sale of our rights to Daraprim®, for which there was no
comparable amount in the prior year.
Loss on Debt Extinguishment
During the year ended December 31, 2015 , we recognized a $16.9 million loss on the extinguishment of debt related to unamortized debt issuance costs
upon the repayment of our term loan with Barclays, for which there was no comparable loss in the prior year.
Net Change in Fair Value of Derivatives
During the year ended December 31, 2015, we recognized a $13.0 million expense as the net change in the fair value of our derivative instruments entered
into in conjunction with our convertible senior notes due 2022. This expense resulted from the change in our stock price from June 30, 2015 to December 31, 2015.
A third party valuation firm with expertise in valuing financial instruments was engaged to determine the fair value of our bond hedge derivative asset and
conversion option derivative liability at each reporting period. There was no comparable change in the fair value of derivatives during the current year.
Other Income, Net
Other income, net of $0.4 million in the year ended December 31, 2015 , was consistent with the prior year, primarily related to our sale of an ANDA
during 2015 for $1.0 million. Partially offsetting this income in 2015 was a fixed asset impairment, for which there was no corresponding charge in the prior year.
Income Taxes
During the year ended December 31, 2015 , we recorded an aggregate tax provision of $20.4 million for U.S. domestic income taxes and for foreign
income taxes, a decrease of $12.8 million compared to an aggregate tax provision of $33.2 million we recorded during the prior year. The decrease in the tax
provision during 2015 compared to the prior year resulted from lower income before taxes in the year ended December 31, 2015. The effective tax rate decreased
to 34% for the year ended December 31, 2015 compared to 37% for the year ended December 31, 2014 . The 2015 effective tax rate was lower due to a change in
the timing and mix of U.S. and foreign income. Other contributing factors to the rate fluctuation included favorable book-tax differences for federal tax benefits,
including the R&D credit and domestic manufacturing deduction, on the Tower entities which we acquired in 2015.
66
Liquidity and Capital Resources
We generally fund our operations with cash from operating activities, although we have also funded our operations with proceeds from the sale of debt
and equity securities. Our cash flows from operating activities consist primarily of the proceeds from sales of our products and services.
We expect to incur significant operating expenses, including research and development and patent litigation expenses, for the foreseeable future. In
addition, we are generally required to make cash expenditures to manufacture and/or acquire finished product inventory in advance of selling the finished product
to our customers and collecting payment, which may result in a significant use of cash. We believe our existing cash and cash equivalents, together with cash
expected to be generated from operations and our revolving line of credit facility, will be sufficient to meet our financing requirements through the next 12 months.
We may, however, seek additional financing through alliance, collaboration, and licensing agreements, as well as from the debt and equity capital markets, to fund
capital expenditures, research and development plans, potential acquisitions, and potential revenue shortfalls due to delays in new product introductions or
otherwise. We cannot be assured that such financing will be available on favorable terms, or at all. Refer to "Item 1A - Risk Factors" above for additional
information related to the risks related to our ability to raise additional funds.
Cash and Cash Equivalents
At December 31, 2016 , we had $180.1 million in cash and cash equivalents, a decrease of $160.3 million as compared to $340.4 million at December 31,
2015 . As more fully discussed below, the decrease in cash and cash equivalents during the year ended December 31, 2016 was driven by net cash used in investing
activities of $627.1 million, partially offset by $391.8 million of net cash provided by financing activities and $74.6 million of net cash provided by operating
activities.
Cash Flows - Year Ended December 31, 2016 Compared to Year Ended December 31, 2015
Net cash provided by operating activities for the year ended December 31, 2016 was $74.6 million, an increase of $2.7 million as compared to the prior
year $71.9 million net cash provided by operating activities. While the 2016 cash flows from operations were relatively stable compared to 2015, there were some
large variations in the line items. Our lower net income during 2016 was more than offset by higher non-cash items. Significant changes in non-cash items during
2016 included higher depreciation and amortization resulting from acquisition activity, non-cash interest expense, intangible asset impairment charges, and the
reserve related to the receivable from Turing. Working capital items also experienced significant changes in 2016 compared to the prior year as increased cash flow
from accounts receivable collections were more than offset by higher cash outflows related to profit sharing payments, higher inventory in support of product
launches as well as lower cash inflows from accounts payable and accrued expenses largely related to payments made on behalf of Turing. Refer to "Item 15.
Financial Information - Notes to Consolidated Financial Statements - Note 4. Summary of Significant Accounting Policies - Concentration of Credit Risk" for
additional information related to the Turing receivable and payments.
Net cash used in investing activities for the year ended December 31, 2016 was $627.1 million, an increase of $159.6 million compared to $467.5 million
in the prior year. In 2016, net cash used in investing activities primarily consisted of a $585.8 million payment to fund the Teva Transaction. Increased capital
expenditures in 2016 were partially offset by proceeds from the repayment by Tolmar of the outstanding $15.0 million balance due to us under the Tolmar Loan
Agreement. Net cash used in investing activities for the prior year included a $691.3 million payment to fund the Tower Acquisition, partially offset by $200.1
million from the maturity of investments and $59.5 million in proceeds from the sale to Turing of our rights to Daraprim®, both of which had no similar activity
during 2016.
Net cash provided by financing activities for the year ended December 31, 2016 was $391.8 million, representing a decrease of $129.6 million as
compared to $521.4 million in the prior year. In 2016, net cash provided by financing activities primarily consisted of $400.0 million of proceeds from the term
loan entered into with Royal Bank of Canada to finance the Teva Transaction. In contrast, prior year net cash provided by financing activities included $600.0
million from the issuance of convertible notes and $88.3 million from the sale of warrants, offset by the payment of $147.0 million to purchase the bond hedge
derivative asset, for which similar activity did not occur during 2016. Refer to "Outstanding Debt Obligations" below for additional information regarding our
outstanding convertible notes and credit facilities.
67
Cash Flows - Year Ended December 31, 2015 Compared to Year Ended December 31, 2014
Net cash provided by operating activities for the year ended December 31, 2015 was $71.9 million, an increase of $39.1 million as compared to the prior
year $32.8 million net cash provided by operating activities. The significant factors contributing to the increased cash flow from operations during 2015 included
increased net profit sharing accruals driven by the product sales mix experienced in the fourth quarter of 2015, increased amortization and impairment charges
related to the Tower Acquisition, increased share based compensation expense, as well as an add back for the write off of deferred financing costs which occurred
in the second quarter of 2015. These increases were partially offset by reduced net income which was largely driven by the absence of sales of authorized generic
Renvela® and a deduction for the gain on sale of our rights to Daraprim® during 2015.
Net cash used in investing activities for the year ended December 31, 2015 was $467.5 million as compared to $16.6 million for the prior year. The period
over period increase in net cash used was due primarily to cash used to fund the Tower Acquisition purchase price of $691.3 million (net of cash acquired in the
acquisition), partially offset by a change in purchases of short term investments and a change in maturities of investments of $170.8 million with those cash
proceeds used in part to fund the Tower Acquisition. Net cash flow from investing activities also included $55.5 million in proceeds from the sale of our rights to
Daraprim® during 2015.
Net cash provided by financing activities for the year ended December 31, 2015 was $521.4 million, representing an increase of $507.0 million as
compared to the prior year $14.4 million of net cash provided by financing activities. The year-over-year increase in net cash provided by financing activities was
due to the sales of our convertible notes and related bond hedge activities. Please refer to “Outstanding Debt Obligations” below for further details.
Commitments and Contractual Obligations
Our contractual obligations as of December 31, 2016 were as follows (in thousands):
Contractual Obligations
Total
Payments Due by Period
Less
Than 1
Year
1-3
Years
3-5
Years
Open Purchase Order Commitments
Operating Leases (a)
Construction Contracts (b)
Total (c)
$
$
129,116 $
129,116 $
30,191
122
5,439
122
159,429 $
134,677 $
— $
9,152
—
9,152 $
— $
4,326
—
4,326 $
More
Than 5
Years
—
11,274
—
11,274
(a) We lease office, warehouse, and laboratory facilities under non-cancelable operating leases with expiration dates through December 2027. We also lease
certain equipment under various non-cancelable operating leases with various expiration dates through October 2021.
(b) Construction contracts are related to ongoing expansion activities at our manufacturing facility in Taiwan.
(c) Liabilities for uncertain tax positions FASB ASC Topic 740, Sub-topic 10, were excluded as we are not able to make a reasonably reliable estimate of the
amount and period of related future payments. As of December 31, 2016 , we had a $4.6 million provision for uncertain tax positions.
Off-Balance Sheet Arrangements
We did not have any off-balance sheet arrangements as of December 31, 2016 and 2015 .
68
Outstanding Debt Obligations
Royal Bank of Canada Credit Facilities
On August 3, 2016, we entered into a restatement agreement with Royal Bank of Canada, as administrative agent, and the lenders and guarantors party
thereto (the "Restatement Agreement"). The Restatement Agreement amends and restates the existing Revolving Credit Facility Agreement (as amended and
restated, the "Amended and Restated Credit Agreement") to, among other things, (i) add a term loan feature to allow for the borrowing of up to $400.0 million of
term loans (the "Term Loan Facility") by us in accordance with the terms of the Amended and Restated Credit Agreement, (ii) increase the aggregate principal
amount of revolving loans permitted under the Amended and Restated Credit Agreement (the "Revolving Credit Facility," and, together with the Term Loan
Facility, the "RBC Credit Facilities"), from $100.0 million to $200.0 million and (iii) extend the maturity date of the Revolving Credit Facility from August 4,
2020 to August 3, 2021.
Borrowings under the Amended and Restated Credit Agreement will accrue interest at a rate equal to LIBOR or the base rate, plus an applicable margin.
The applicable margin may be increased or reduced by 0.25% based on our total net leverage ratio. Up to $12.5 million of the Revolving Credit Facility is available
for issuance of letters of credit and any such letters of credit will reduce the amount available under the Revolving Credit Facility on a dollar-for-dollar basis. We
are required to pay a commitment fee to the lenders on the average daily unused portion of the Revolving Credit Facility at 0.50% or 0.375% per annum,
depending our total net leverage ratio.
The Amended and Restated Credit Agreement contains certain negative covenants (subject to exceptions, materiality thresholds and other allowances)
including, without limitation, negative covenants that limit our and our restricted subsidiaries' ability to incur additional debt, guarantee other obligations, grant
liens on assets, make loans, acquisitions or other investments, dispose of assets, make optional payments in connection with or modify certain debt instruments,
pay dividends or make other payments on capital stock, engage in mergers or consolidations, enter into arrangements that restrict our and our restricted
subsidiaries' ability to pay dividends or grant liens, engage in transactions with affiliates, or change our fiscal year. The Amended and Restated Credit Agreement
also includes a financial maintenance covenant whereby we must not permit our total net leverage ratio in any 12-month period to exceed 5.00:1.00, as tested at the
end of each fiscal quarter. We were in compliance with all of our covenants under the Amended and Restated Credit Agreement as of December 31, 2016.
The Amended and Restated Credit Agreement contains events of default, including, without limitation (subject to customary grace periods and materiality
thresholds), events of default upon (i) the failure to make payments pursuant to the terms of the Amended and Restated Credit Agreement, (ii) violation of
covenants, (iii) incorrectness of representations and warranties, (iv) cross-default and cross-acceleration to other material indebtedness, (v) bankruptcy events, (vi)
material monetary judgments (to the extent not covered by insurance), (vii) certain matters arising under the Employee Retirement Income Security Act of 1974, as
amended, that could reasonably be expected to result in a material adverse effect, (viii) the actual or asserted invalidity of the documents governing the RBC Credit
Facilities, any material guarantees or the security interests (including priority thereof) required under the Amended and Restated Credit Agreement and (ix) the
occurrence of a change of control (as defined therein). Upon the occurrence of certain events of default, the obligations under the Amended and Restated Credit
Agreement may be accelerated and any remaining commitments thereunder may be terminated.
The full amount of the proceeds from the Term Loan Facility of $400.0 million, along with $196.4 million of cash were used to finance the Teva
Transaction, including transaction fees, on its closing date of August 3, 2016. As of December 31, 2016, the full amount of the $200.0 million Revolving Credit
Facility remains available to us for working capital and other general corporate purposes.
In connection with the Term Loan Facility, we incurred $11.0 million of debt issuance costs for banking, legal and accounting fees and other expenses
which were recorded on our consolidated balance sheet as a reduction to the current and long-term portions of debt related to the Term Loan Facility. These
deferred debt issuance costs will be accreted to interest expense over the term of the debt using the effective interest method. In connection with the increase in the
aggregate principal amount of revolving loans permitted under the Revolving Credit Facility, we incurred $0.8 million of debt issuance costs for banking fees
which were recorded as an asset with current and long-term portions on our consolidated balance sheet. These deferred debt issuance costs, in addition to the $0.3
million balance remaining from the initial balance remaining from the initial $100.0 million revolving credit facility, will be amortized to interest expense over the
term of the Revolving Credit Facility using the straight-line method.
69
For the period of August 3, 2016 through December 31, 2016 , we recognized $6.9 million of interest expense related to the Term Loan Facility, of which
$6.0 million was cash and $0.9 million was non-cash accretion of debt discounts recorded for deferred debt issuance costs. As of December 31, 2016 , the Term
Loan Facility had a carrying value of $384.9 million, of which $17.7 million is classified as current debt and $367.2 million is classified as long-term debt on our
consolidated balance sheet. The Term Loan Facility requires quarterly principal payments of $5.0 million beginning from December 2016 through June 2021, and
the remaining principal balance is payable in August 2021. As of December 31, 2016, the outstanding principal amount for the Term Loan Facility was $395.0
million.
On February 28, 2017, we made a voluntary prepayment in the amount of $50.3 million under our Term Loan Facility representing $50.0 million of
principal amount and $0.3 million of accrued interest thereon. As a result of the payment, the outstanding principal amount on the Term Loan Facility decreased to
$345.0 million.
2% Convertible Senior Notes due June 2022
On June 30, 2015, we issued an aggregate principal amount of $600.0 million of 2.00% Convertible Senior Notes due June 2022 (the “Notes”) in a private
placement offering, which are our senior unsecured obligations. The Notes were issued pursuant to an Indenture dated June 30, 2015 (the “Indenture”) between us
and Wilmington Trust, N.A., as trustee. The Indenture includes customary covenants and sets forth certain events of default after which the Notes may be due and
payable immediately. The Notes will mature on June 15, 2022, unless earlier redeemed, repurchased or converted. The Notes bear interest at a rate of 2.00% per
year, and interest is payable semiannually in arrears on June 15 and December 15 of each year, beginning on December 15, 2015.
The conversion rate for the Notes is initially set at 15.7858 shares per $1,000 of principal amount, which is equivalent to an initial conversion price of
$63.35 per share of our common stock. If a Make-Whole Fundamental Change (as defined in the Indenture) occurs or becomes effective prior to the maturity date
and a holder elects to convert its Notes in connection with the Make-Whole Fundamental Change, we are obligated to increase the conversion rate for the Notes so
surrendered by a number of additional shares of our common stock as prescribed in the Indenture. Additionally, the conversion rate is subject to adjustment in the
event of an equity restructuring transaction such as a stock dividend, stock split, spinoff, rights offering, or recapitalization through a large, nonrecurring cash
dividend (“standard antidilution provisions,” per ASC 815-40 – Contracts in Entity’s Own Equity).
The Notes are convertible at the option of the holders at any time prior to the close of business on the business day immediately preceding December 15,
2021 only under the following circumstances:
(i)
If during any calendar quarter commencing after the quarter ending September 30, 2015 (and only during such calendar quarter) the last reported
sale price of our common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on
the last trading day of the immediately preceding calendar quarter is greater than 130% of the conversion price on each applicable trading day; or
(ii) If during the five business day period after any 10 consecutive trading day period (the “measurement period”) in which the trading price per $1,000
of principal amount of Notes for each trading day of the measurement period was less than 98% of the product of the last report sale price of our
common stock and the conversion rate on each such trading day; or
(iii) Upon the occurrence of corporate events specified in the Indenture.
On or after December 15, 2021 until the close of business on the second scheduled trading day immediately preceding the maturity date, the holders may
convert their Notes at any time, regardless of the foregoing circumstances. We may satisfy our conversion obligation by paying or delivering, as the case may be,
cash, shares of our common stock, or a combination of cash and shares of our common stock, at our election and in the manner and subject to the terms and
conditions provided in the Indenture.
Concurrently with the offering of the Notes and using a portion of the proceeds from the sale of the Notes, we entered into a series of convertible note
hedge and warrant transactions (the “Note Hedge Transactions” and “Warrant Transactions”) which are designed to reduce the potential dilution to our
stockholders and/or offset the cash payments we are required to make in excess of the principal amount upon conversion of the Notes. The Note Hedge
Transactions and Warrant Transactions are separate transactions, in each case, entered into by us with a financial institution and are not part of the terms of the
Notes. These transactions will not affect any holder’s rights under the Notes, and the holders of the Notes have no rights with respect to the Note Hedge
Transactions and Warrant Transactions. See “Note 13. Debt” and “Note 14. Stockholders’ Equity” for additional information.
70
For the years ended December 31, 2016 and December 31, 2015 , we recognized $33.8 million and $16.3 million, respectively, of interest expense related
to the Notes, of which $12.0 million and $6.0 million, respectively, was cash and $21.8 million and $10.3 million, respectively, was non-cash accretion of the debt
discounts recorded. As the Notes mature in 2022, they have been classified as long-term debt on our consolidated balance sheet, with a carrying value of $446.4
million and $424.6 million as of December 31, 2016 and December 31, 2015 , respectively. Accrued interest payable on the Notes of $0.5 million as of both
December 31, 2016 and December 31, 2015 is included in accrued expenses on our consolidated balance sheets.
Loss on Early Extinguishment of Debt – Barclays $435.0 Million Term Loan
In connection with the Tower Acquisition during the first quarter of 2015, we entered into a $435.0 million senior secured term loan facility (the
“Barclays Term Loan”) and a $50.0 million senior secured revolving credit facility (the “Barclays Revolver” and collectively with the Barclays Term Loan, the
“Barclays Senior Secured Credit Facilities”), pursuant to a credit agreement, dated as of March 9, 2015, by and among us, the lenders party thereto from time to
time and Barclays Bank PLC ("Barclays"), as administrative and collateral agent (the “Barclays Credit Agreement”). In connection with the Barclays Senior
Secured Credit Facilities, we incurred debt issuance costs for banking, legal and accounting fees and other expenses of approximately $17.8 million during the first
quarter of 2015, which were previously reflected as a discount to the carrying value of the debt on our consolidated balance sheet in accordance with ASU 2015-
03. Prior to repayment of the Barclays Term Loan on June 30, 2015, this debt discount was accreted to interest expense over the term of the loan using the effective
interest rate method.
On June 30, 2015, we used $436.4 million of the proceeds from the sale of the Notes to repay the $435.0 million of principal and $1.4 million of accrued
interest due on the Barclays Term Loan under the Barclays Credit Agreement. In connection with this repayment of the loan, for the quarter ended June 30, 2015,
we recorded a loss on early extinguishment of debt of $16.9 million related to the unaccreted portion of the debt discount.
For the six months ended June 30, 2015, we incurred total interest expense related to the Barclays Term Loan of $10.7 million, of which $9.8 million was
cash and $0.9 million was non-cash accretion of the debt discount recorded. In addition, included in interest expense for 2015 is a $2.3 million ticking fee paid to
Barclays during the first quarter of 2015, prior to the funding of the Barclays Senior Secured Credit Facilities on March 9, 2015, to lock in the financing terms from
the lenders’ commitment of the Barclays Term Loan until the actual allocation of the loan occurred at the closing of the Tower Acquisition.
Recent Accounting Pronouncements
Recently issued accounting standards are discussed in "Item 15. Exhibits and Financial Statements - Notes to Consolidated Financial Statements - Note 5.
Recent Accounting Pronouncements."
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
Our cash is held on deposit in demand accounts at large financial institutions in amounts in excess of the Federal Deposit Insurance Corporation (FDIC)
insurance coverage limit of $250,000 per depositor, per FDIC-insured bank, per ownership category. Our cash equivalents are comprised of highly-rated money
market funds. We had no short-term investments as of December 31, 2016 or 2015 . Previously, our short-term investments included a portfolio of high credit
quality debt securities, including U.S. government securities, treasury bills, and short-term commercial paper.
Financial instruments that potentially subject us to concentrations of credit risk consist principally of cash equivalents and accounts receivable. We limit
our credit risk associated with cash equivalents by placing investments with high credit quality securities, including U.S. government securities, treasury bills,
corporate debt, short-term commercial paper and highly-rated money market funds. As discussed above under “Item 7. Outstanding Debt Obligations,” we are
party to a Term Loan facility of $400.0 million and a Revolving Credit Facility of up to $200.0 million pursuant to the RBC Credit Facilities. The amount under
our Revolving Credit Facility is available for working capital and other general corporate purposes. We also issued the Notes in a private placement offering on
June 30, 2015, which are our senior unsecured obligations, as described above under “Outstanding Debt Obligations.”
We limit our credit risk with respect to accounts receivable by performing credit evaluations when deemed necessary. We do not require collateral to
secure amounts owed to us by our customers. As discussed above under "Item 15. Exhibits and Financial Statement Schedules - Notes to Consolidated Financial
Statements - Note 4. Summary of Significant Accounting Policies - Concentration of Credit Risk” we recorded a reserve in the amount of $48.0 million on our
consolidated statement of operations for the period ended March 31, 2016, representing the full amount of the estimated receivable due from Turing for
reimbursement of Daraprim® chargebacks and Medicaid rebate liabilities as of March 31, 2016. During the fourth quarter of 2016, we received $7.7 million in
payments from Turing, which reduced the reserve balance to $40.3 million as of December 31, 2016 .
71
Prior to June 30, 2015, we had no derivative assets or liabilities and did not engage in any hedging activities. As a result of our June 30, 2015 issuance of
the Notes described above under “Item 7. Outstanding Debt Obligations” and in “Item 15. Exhibits and Financial Statement Schedules - Note 13. Debt”, we
entered into a series of convertible note hedge and warrant transactions (the “Note Hedge Transactions” and “Warrant Transactions”) which are designed to reduce
the potential dilution to our stockholders and/or offset the cash payments we are required to make in excess of the principal amount upon conversion of the Notes.
We do not use derivative financial instruments or engage in hedging activities in our ordinary course of business and have no material foreign currency
exchange exposure or commodity price risks. See “Item 15. Exhibits and Financial Statement Schedules – Note 23. Segment Information” for more information
regarding the value of our investment in Impax Laboratories (Taiwan), Inc.
We do not believe that inflation has had a significant impact on our revenues or operations to date.
Item 8. Financial Statements and Supplementary Data
The consolidated financial statements and schedule listed in the Index to Financial Statements beginning on page F-1 are filed as part of this Annual
Report on Form 10-K and incorporated by reference herein.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Not applicable.
72
Item 9A. Controls and Procedures
Disclosure Controls and Procedures
We maintain disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act) that are designed to ensure information required to be
disclosed by us in reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s
rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial
officer, as appropriate, to allow timely decisions regarding required disclosure.
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls
and procedures as of the end of the period covered by this Annual Report on Form 10-K. Based upon this evaluation, our Chief Executive Officer and Chief
Financial Officer concluded that our disclosure controls and procedures, as defined in Rule 13a-15(e) of the Exchange Act, were effective as of December 31, 2016
at the reasonable assurance level.
Management Report on Internal Control Over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Exchange Act Rule 13a-
15(f), to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles used in the United States (GAAP). Internal control over financial reporting includes our policies and
procedures, such as our Code of Conduct, which (i) require our employees, directors and contingent workers and business partners who perform work on our
behalf to adhere to certain ethical standards; (ii) require the maintenance of records, in reasonable detail, to help to ensure that our transactions, assets and
liabilities are accurately and fairly recorded; (iii) provide reasonable assurance that transactions are authorized by our management and directors and are recorded
as necessary to allow for the accurate preparation of financial statements in accordance with GAAP; and (iv) provide reasonable assurance regarding the
safeguarding of our assets and the prevention or timely detection of the unauthorized acquisition, use or disposition of our assets which could have a material effect
on the financial statements. Internal control over financial reporting includes the controls themselves, management’s monitoring of those controls, the independent
assessment of the design and effectiveness of those controls by our internal audit team, actions taken to correct deficiencies as identified, and oversight of our
internal control environment by our Audit Committee of our Board of Directors. Any system of internal control has inherent limitations and therefore may not
prevent or detect misstatements. Projections of any evaluation of the effectiveness of internal control over financial reporting to future periods has risks as controls
may become inadequate over time because of changes in conditions.
Management assessed the effectiveness of our internal control over financial reporting as of December 31, 2016 , the end of our fiscal year, and has
reviewed the results of this assessment with the Audit Committee of our Board of Directors. Management based its assessment on criteria established in Internal
Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Management’s assessment included
evaluation of such elements as the design and operating effectiveness of key financial reporting controls, process documentation, accounting policies, and our
overall control environment. Based on the assessment, management has concluded our internal control over financial reporting was effective as of the end of the
fiscal year 2016 to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external reporting
purposes in accordance with GAAP.
The scope of management’s assessment of the effectiveness of its internal control over financial reporting as of December 31, 2016 included our
consolidated operations.
The effectiveness of our internal control over financial reporting as of December 31, 2016 has been audited by KPMG LLP, an independent registered
public accounting firm, as stated in their report which is included immediately below.
73
The Board of Directors and Stockholders
Impax Laboratories, Inc.:
Report of Independent Registered Public Accounting Firm
We have audited Impax Laboratories, Inc.’s internal control over financial reporting as of December 31, 2016 , based on criteria established in Internal
Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Impax Laboratories, Inc.’s
management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over
financial reporting, included in the accompanying Management Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on
the Company’s internal control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require
that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing
and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audit also included performing such other procedures as
we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over
financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of
financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in
accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation
of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
In our opinion, Impax Laboratories, Inc. maintained, in all material respects, effective internal control over financial reporting as of December 31, 2016 ,
based on criteria established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway
Commission.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance
sheets of Impax Laboratories, Inc. and subsidiaries as of December 31, 2016 and 2015 , and the related consolidated statements of operations, comprehensive (loss)
income, changes in stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2016 , and the related financial
statement schedule, and our report dated March 1, 2017 , expressed an unqualified opinion on those consolidated financial statements and the related financial
statement schedule.
/s/ KPMG LLP
Philadelphia, Pennsylvania
March 1, 2017
74
Changes in Internal Control over Financial Reporting
During the quarter ended December 31, 2016 , there were no changes in the Company’s internal control over financial reporting (as defined in Rule 13a-
15(f) of the Exchange Act) which materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
Item 9B. Other Information
None.
75
Item 10. Directors, Executive Officers and Corporate Governance
Code of Conduct
PART III.
We have adopted a Code of Conduct, which was amended and restated effective February 16, 2016 (“Code of Conduct”). The Code of Conduct applies to
all of our directors, employees, including our Chief Executive Officer, Chief Financial Officer and any other accounting officer, controller or persons performing
similar functions, and contingent workers and business partners who perform work on our behalf. The Code of Conduct is available on our website
(www.impaxlabs.com) and accessible via the “Investor Relations” page. Any amendments to, or waivers of, the Code of Conduct will be disclosed on our website
within four business days following the date of such amendment or waiver.
Additional information required by this item is incorporated by reference to our definitive proxy statement for the Annual Meeting of Stockholders to be
held on May 16, 2017 (“Proxy Statement”).
Item 11. Executive Compensation
The information required by this item is incorporated by reference to the Proxy Statement.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this item is incorporated by reference to the Proxy Statement, except information concerning the equity compensation plans
table which is set forth in “Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities” and which is
incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this item is incorporated by reference to the Proxy Statement.
Item 14. Principal Accounting Fees and Services
The information required by this item is incorporated by reference to the Proxy Statement.
76
Item 15. Exhibits and Financial Statement Schedules
(a)(1) Consolidated Financial Statements
PART IV.
The consolidated financial statements listed in the Index to Financial Statements beginning on page F-1 are filed as part of this Annual Report on Form
10-K.
(a)(2) Financial Statement Schedules
The financial statement schedule listed in the Index to Financial Statements on page F-1 is filed as part of this Annual Report on Form 10-K.
(a)(3) Exhibits
Exhibit No.
Description of Document
EXHIBIT INDEX
2.1
3.1.1
3.1.2
3.1.3
3.2.1
3.2.2
3.2.3
3.2.4
3.2.5
3.2.6
3.2.7
3.2.8
4.1
4.2
4.3
10.1
10.2
10.3
Stock Purchase Agreement, dated as of October 8, 2014, by and among the Company, Tower Holdings, Inc. (“Tower”), Lineage Therapeutics
Inc. (“Lineage”), Roundtable Healthcare Partners II, L.P., Roundtable Healthcare Investors II, L.P., the other stockholders of Tower and
Lineage, the holders of options to purchase shares of Tower common stock and options to purchase shares of Lineage common stock, the
holders of warrants to acquire shares of Tower common stock and warrants to acquire shares of Lineage common stock and, solely with
respect to Section 8.3, Roundtable Healthcare Management II, LLC. †(1)
Certificate of Amendment of the Restated Certificate of Incorporation of the Company dated as of December 9, 2015.(2)
Restated Certificate of Incorporation of the Company dated as of August 30, 2004.(3)
Certificate of Designation of Series A Junior Participating Preferred Stock, as filed with the Secretary of State of Delaware on January 21,
2009.(4)
Amendment No. 7 to Amended and Restated Bylaws of the Company, effective as of December 19, 2016.
Amendment No. 6 to Amended and Restated Bylaws of the Company, effective as of November 23, 2016.
Amendment No. 5 to Amended and Restated Bylaws of the Company, effective as of August 19, 2016.
Amendment No. 4 to Amended and Restated Bylaws of the Company, effective as of May 17, 2016.
Amendment No. 3 to Amended and Restated Bylaws of the Company, effective as of October 7, 2015.
Amendment No. 2 to Amended and Restated Bylaws of the Company, effective as of July 7, 2015.
Amendment No. 1 to Amended and Restated Bylaws of the Company, effective as of March 24, 2015.
Amended and Restated Bylaws of the Company, effective as of May 14, 2014.
Specimen of Common Stock Certificate.(5)
Preferred Stock Rights Agreement, dated as of January 20, 2009, by and between the Company and StockTrans, Inc., as Rights Agent.(4)
Indenture, dated as of June 30, 2015, between the Company, and Wilmington Trust, National Association, as trustee.(6)
Letter Agreement, dated as of June 25, 2015, between RBC Capital Markets LLC and the Company regarding the Base Warrants.(6)
Letter Agreement, dated as of June 25, 2015 between RBC Capital Markets LLC and the Company regarding the Base Call Option
Transaction.(6)
Letter Agreement, dated as of June 26, 2015, between RBC Capital Markets LLC and the Company regarding the Additional Warrants.(6)
77
10.4
10.5
10.6
10.7.1
10.7.2
10.8.1
10.8.2
10.9.1
10.9.2
10.10.1
10.10.2
10.11.1
10.11.2
10.12
10.13.1
10.13.2
10.14
10.15.1
10.15.2
10.15.3
10.16.1
10.16.2
10.17.1
Letter Agreement, dated as of June 26, 2015, between RBC Capital Markets LLC and the Company regarding the Additional Call Option
Transaction.(6)
Credit Agreement, dated as of August 4, 2015, by and among the Company, the lenders party thereto from time to time and Royal Bank of
Canada, as administrative agent and collateral agent.(7)
Restatement Agreement, dated as of August 3, 2016, by and the Company, the guarantors party thereto, Royal Bank of Canada, as
administrative agent, and the lenders party thereto.(8)
First Amendment, dated as of May 31, 2016, to the Distribution, License, Development and Supply Agreement by and between AstraZeneca
UK Limited and the Company dated as of January 31, 2012.**(8)
Distribution, License, Development and Supply Agreement, dated as of January 31, 2012, between the Company and AstraZeneca UK
Limited.**(9)
Asset Purchase Agreement, dated as of June 20, 2016, between Teva Pharmaceutical Industries Ltd. and the Company. †**(10)
Amendment No. 1 dated as of June 30, 2016 to the Asset Purchase Agreement between Teva Pharmaceutical Industries Ltd. and the Company
dated as of June 20, 2016.(8)
Asset Purchase Agreement, dated as of June 20, 2016, by and among Actavis Elizabeth LLC, Actavis Group PTC Ehf., Actavis Holdco US,
Inc., Actavis LLC, Actavis Mid Atlantic LLC, Actavis Pharma, Inc., Actavis South Atlantic LLC, Andrx LLC, Breath Ltd., The Rugby Group,
Inc., Watson Laboratories, Inc. and the Company. †**(10)
Amendment No. 1 dated as of June 30, 2016 to the Asset Purchase Agreement by and among Actavis Elizabeth LLC, Actavis Group PTC
Ehf., Actavis Holdco US, Inc., Actavis LLC, Actavis Mid Atlantic LLC, Actavis Pharma, Inc., Actavis South Atlantic LLC, Andrx LLC,
Breath Ltd., The Rugby Group, Inc., Watson Laboratories, Inc. and the Company dated as of June 20, 2016. **(10)
Supply Agreement, dated as of June 20, 2016, between Teva Pharmaceutical Industries Ltd. and the Company.**(10)
Amendment No. 1, dated as of June 30, 2016, to the Supply Agreement between Teva Pharmaceutical Industries Ltd. and the Company dated
as of June 20, 2016.**(10)
Supply Agreement, dated as of June 20, 2016, by and among Actavis Elizabeth LLC, Actavis Group PTC Ehf., Actavis Holdco US, Inc.,
Actavis LLC, Actavis Mid Atlantic LLC, Actavis Pharma, Inc., Actavis South Atlantic LLC, Andrx LLC, Breath Ltd., The Rugby Group, Inc.,
Watson Laboratories, Inc. and the Company.**(10)
Amendment No. 1, dated as of June 30, 2016, to the Supply Agreement by and among Actavis Elizabeth LLC, Actavis Group PTC Ehf.,
Actavis Holdco US, Inc., Actavis LLC, Actavis Mid Atlantic LLC, Actavis Pharma, Inc., Actavis South Atlantic LLC, Andrx LLC, Breath
Ltd., The Rugby Group, Inc., Watson Laboratories, Inc. and the Company dated as of June 20, 2016.**(10)
Amended and Restated License and Distribution Agreement, dated as of February 7, 2013, between the Company and Shire LLC.**(11)
Impax Laboratories, Inc. 1999 Equity Incentive Plan.*(12)
Form of Stock Option Grant under the Impax Laboratories, Inc. 1999 Equity Incentive Plan.*(12)
Impax Laboratories, Inc. 2001 Non-Qualified Employee Stock Purchase Plan.*(5)
Impax Laboratories, Inc. Third Amended and Restated 2002 Equity Incentive Plan.*(13)
Form of Stock Option Agreement under the Impax Laboratories, Inc. Third Amended and Restated 2002 Equity Incentive Plan.*(14)
Form of Restricted Stock (Stock Bonus) Agreement under the Impax Laboratories, Inc. Third Amended and Restated 2002 Equity Incentive
Plan.*(15)
Impax Laboratories, Inc. Executive Non-Qualified Deferred Compensation Plan, amended and restated effective January 1, 2008.*(16)
Amendment to Impax Laboratories, Inc. Executive Non-Qualified Deferred Compensation Plan, effective as of January 1, 2009.* (16)
Employment Agreement, dated as of January 1, 2010, between the Company and Charles V. Hildenbrand.*(17)
78
10.17.2
10.18.1
10.18.2
10.19
10.20.1
10.20.2
10.21.1
10.21.2
10.22
10.23.1
10.23.2
10.23.3
10.24.1
10.24.2
10.25.1
10.25.2
Confidential Separation and Release Agreement, dated as of July 5, 2011, between the Company and Charles V. Hildenbrand.*(18)
Employment Agreement, dated as of January 1, 2010, between the Company and Arthur A. Koch, Jr.*(17)
General Release and Waiver, effective as of July 17, 2012, between the Company and Arthur A. Koch, Jr.* (19)
Letter Agreement between J. Kevin Buchi, dated as of December 19, 2016, between the Company and J. Kevin Buchi.*
Employment Agreement, dated as of April 21, 2014, by and between the Company and G. Frederick Wilkinson.*(20)
General Release and Waiver, dated as of December 19, 2016, by and between the Company and G. Frederick Wilkinson.*
Employment Agreement, dated as of January 1, 2010, between the Company and Michael J. Nestor.*(17)
Amendment, dated as of April 1, 2014, to the Employment Agreement, dated as of January 1, 2014, between the Company and Michael
Nestor.*(21)
Employment Agreement, dated as of July 14, 2016, between the Company and Douglas S. Boothe.*(8)
Offer of Employment Letter, dated as of March 17, 2011, between the Company and Mark A. Schlossberg.*(22)
Employment Agreement, dated as of May 2, 2011, between the Company and Mark A. Schlossberg.*(22)
Amendment, dated as of April 1, 2014, to the Employment Agreement, dated as of May 2, 2011, between the Company and Mark A.
Schlossberg.*(21)
Employment Agreement, dated as of December 12, 2012, between the Company and Bryan M. Reasons.*(23)
Amendment, dated as of April 1, 2014, to the Employment Agreement, dated as of December 12, 2012 between the Company and Bryan M.
Reasons.*(21)
Employment Agreement, dated as of November 28, 2011, by and between the Company and Jeffrey Nornhold.*(24)
Amendment, dated as of April 1, 2014, to the Employment Agreement, dated as of November 28, 2011, by and between the Company and
Jeffrey Nornhold.*(24)
10.25.3
Letter Agreement, dated as of April 1, 2014, between the Company and Jeffrey Nornhold.*(24)
11.1
21.1
23.1
31.1
31.2
32.1
32.2
101
Statement re computation of per share earnings (incorporated by reference to Note 15 to the Notes to Consolidated Financial Statements in this
Annual Report on Form 10-K).
Subsidiaries of the registrant.
Consent of Independent Registered Public Accounting Firm.
Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
Certification of the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
The following materials from the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, formatted in XBRL
(eXtensible Business Reporting Language): (i) Consolidated Balance Sheets as of December 31, 2016 and 2015, (ii) Consolidated Statements
of Operations for each of the three years in the period ended December 31, 2016, (iii) Consolidated Statements of Comprehensive (Loss)
Income for each of the three years in the period ended December 31, 2016, (iv) Consolidated Statements of Changes in Stockholders’ Equity
for each of the three years in the period ended December 31, 2016, (v) Consolidated Statements of Cash Flows for each of the three years in
the period ended December 31, 2016 and (vi) Notes to Consolidated Financial Statements for each of the three years in the period ended
December 31, 2016.
79
*
**
†
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
(18)
(19)
(20)
(21)
(22)
(23)
(24)
Management contract, compensatory plan or arrangement.
Confidential treatment granted for certain portions of this exhibit pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), which portions are omitted and filed separately with the SEC.
Schedules omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company agrees to furnish a supplemental copy of any omitted schedule to the
SEC upon request.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on October 10, 2014.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on December 9, 2015.
Incorporated by reference to Amendment No. 5 to the Company’s Registration Statement on Form 10 filed on December 23, 2008.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on January 22, 2009.
Incorporated by reference to the Company’s Registration Statement on Form 10 filed on October 10, 2008.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on June 30, 2015.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on August 5, 2015.
Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016.
Incorporated by reference to the Company’s Current Report on Form 8-K/A filed on April 2, 2012.
Incorporated by reference to the Company’s Quarterly Report on Form 10-Q/A for the quarter ended June 30, 2016 filed on January 6, 2017.
Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2013.
Incorporated by reference to the Company’s Annual Report on Form 10-K for the year ended December 31, 2008.
Incorporated by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A (File No. 001-34263) filed on April 14, 2016.
Incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-8 (File No. 333-189360) filed on June 14, 2013.
Incorporated by reference to Exhibit 4.6 to the Company’s Registration Statement on Form S-8 (File No. 333-189360) filed on June 14, 2013.
Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2010.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on January 14, 2010.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on July 11, 2011.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on July 18, 2012.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on April 24, 2014.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on April 2, 2014.
Incorporated by reference to the Company’s Annual Report on Form 10-K for the year ended December 31, 2011.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on December 13, 2012.
Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2014.
80
Impax Laboratories, Inc.
INDEX TO FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets as of December 31, 201 6 and 2015
Consolidated Statements of Operations for the years ended December 31, 2016, 2015, and 2014
Consolidated Statements of Comprehensive (Loss) Income for the years ended December 31, 2016, 2015, and 2014
Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 201 6, 2015, and 2014
Consolidated Statements of Cash Flows for the years ended December 31, 201 6, 2015, and 2014
Notes to Consolidated Financial Statements
Schedule II, Valuation and Qualifying Accounts
F-1
F-2
F-3
F-4
F-5
F-6
F-7
F-9
S-1
The Board of Directors and Stockholders
Impax Laboratories, Inc.
Report of Independent Registered Public Accounting Firm
We have audited the accompanying consolidated balance sheets of Impax Laboratories, Inc. and subsidiaries as of December 31, 2016 and 2015 , and the
related consolidated statements of operations, comprehensive (loss) income, changes in stockholders’ equity, and cash flows for each of the years in the three-year
period ended December 31, 2016 . In connection with our audits of the consolidated financial statements, we have also audited the related financial statement
schedule. These consolidated financial statements and the related financial statement schedule are the responsibility of the Company’s management. Our
responsibility is to express an opinion on these consolidated financial statements and financial statement schedule based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require
that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes
examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles
used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Impax Laboratories,
Inc. and subsidiaries as of December 31, 2016 and 2015 , and the results of their operations and their cash flows for each of the years in the three-year period ended
December 31, 2016 , in conformity with U.S. generally accepted accounting principles. Also in our opinion, the related financial statement schedule, when
considered in relation to the basic consolidated financial statements taken as a whole, presents fairly, in all material respects, the information set forth therein.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Impax Laboratories, Inc.’s
internal control over financial reporting as of December 31, 2016 , based on criteria established in Internal Control – Integrated Framework (2013) issued by the
Committee of Sponsoring Organizations of the Treadway Commission (COSO), and our report dated March 1, 2017 expressed an unqualified opinion on the
effectiveness of the Company’s internal control over financial reporting.
/s/ KPMG LLP
Philadelphia, Pennsylvania
March 1, 2017
F-2
Assets
Current assets:
Cash and cash equivalents
Accounts receivable, net
Inventory, net
Prepaid expenses and other current assets
Total current assets
Property, plant and equipment, net
Intangible assets, net
Goodwill
Deferred income taxes, net
Other non-current assets
Total assets
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
Accrued expenses
Accrued profit sharing and royalty expenses
Current portion of long-term debt, net
Total current liabilities
Long-term debt, net
Deferred income taxes
Other non-current liabilities
Total liabilities
Commitments and contingencies (Note 21)
Stockholders’ equity:
IMPAX LABORATORIES, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
December 31, 2016 December 31, 2015
$
180,133 $
257,368
175,230
18,410
631,141
233,372
620,466
207,329
69,866
60,844
340,351
324,451
125,582
31,689
822,073
214,156
602,020
210,166
315
73,757
1,823,018 $
1,922,487
$
$
58,952 $
231,011
13,642
17,719
321,324
813,545
—
64,175
1,199,044
—
739
(2,157)
535,056
98,192
(7,856)
623,974
56,325
204,711
65,725
—
326,761
424,595
72,770
35,952
860,078
—
729
(2,157)
504,077
570,223
(10,463)
1,062,409
1,922,487
Preferred stock, $0.01 par value; 2,000,000 shares authorized; No shares issued or outstanding at December 31,
2016 and 2015
Common stock, $0.01 par value; 150,000,000 shares authorized; 73,948,340 issued and 73,704,611 outstanding
shares at December 31, 2016; 72,926,205 issued and 72,682,476 outstanding shares at December 31, 2015
Treasury stock at cost: 243,729 shares at December 31, 2016 and 2015
Additional paid-in capital
Retained earnings
Accumulated other comprehensive loss
Total stockholders’ equity
Total liabilities and stockholders’ equity
The accompanying notes are an integral part of these consolidated financial statements.
F-3
$
1,823,018 $
IMPAX LABORATORIES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
Years Ended December 31,
2016
2015
2014
$
606,320 $
710,932 $
Revenues:
Impax Generics, net
Impax Specialty Pharma, net
Total revenues
Cost of revenues
Cost of revenues impairment charges
Gross (loss) profit
Operating expenses:
Selling, general and administrative
Research and development
In-process research and development impairment charges
Patent litigation
Total operating expenses
(Loss) income from operations
Other income (expense):
Interest expense
Interest income
Reserve for Turing receivable
Gain on sale of asset
Loss on debt extinguishment
Net change in fair value of derivatives
Other, net
(Loss) income before income taxes
(Benefit from) provision for income taxes
Net (loss) income
Net (loss) income per common share:
Basic
Diluted
Weighted-average common shares outstanding:
Basic
Diluted
218,109
824,429
486,899
488,632
(151,102)
201,830
80,466
52,965
7,819
343,080
(494,182)
(41,441)
1,022
(40,312)
—
—
—
(1,412)
(576,325)
(104,294)
149,537
860,469
500,762
7,303
352,404
201,287
70,622
6,360
4,567
282,836
69,568
(27,268)
1,042
—
45,574
(16,903)
(13,000)
355
59,368
20,371
(472,031) $
38,997 $
549,082
46,967
596,049
280,520
2,876
312,653
139,390
78,642
—
5,805
223,837
88,816
(43)
1,473
—
—
—
—
313
90,559
33,206
57,353
$
$
$
(6.63) $
(6.63) $
0.56 $
0.54 $
0.84
0.81
71,147,397
71,147,397
69,640,417
72,027,344
68,185,552
70,530,349
The accompanying notes are an integral part of these consolidated financial statements.
F-4
IMPAX LABORATORIES, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME
(In thousands)
Net (loss) income
Other comprehensive (loss) income component:
Currency translation adjustments
Comprehensive (loss) income
Years Ended December 31,
2016
2015
2014
(472,031) $
38,997 $
57,353
2,607
(469,424) $
(4,454)
34,543 $
(7,149)
50,204
$
$
The accompanying notes are an integral part of these consolidated financial statements.
F-5
IMPAX LABORATORIES, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(In thousands)
Common Stock
Additional
Accumulated
Other
Number of
Shares
Par
Value
Treasury
Stock
Paid-in
Capital
Retained
Earnings
Comprehensive
Income (Loss)
Total
Balance, December 31, 2013
69,684 $
699 $
(2,157) $ 336,648 $ 473,873 $
1,140 $ 810,203
Net income
Other comprehensive loss:
Currency translation adjustment
Exercises of stock options, issuances of restricted stock
and sales of common stock under ESPP
Share-based compensation
Tax benefit related to exercises of stock options and
vestings of restricted stock
—
—
—
—
57,353
—
57,353
—
1,544
—
—
—
15
—
—
—
—
—
—
3,255
20,883
—
3,317
—
—
—
—
(7,149)
(7,149)
—
—
3,270
20,883
—
3,317
Balance, December 31, 2014
71,228 $
714 $
(2,157) $ 364,103 $ 531,226 $
(6,009)
$ 887,877
Net income
Other comprehensive loss:
Currency translation adjustment
Exercises of stock options, issuances of restricted stock
and sales of common stock under ESPP
Share-based compensation
Sale of warrants
Reclassification of derivatives to equity, net of related
taxes
Tax benefit related to exercises of stock options and
vestings of restricted stock
—
—
—
—
38,997
—
38,997
—
1,698
—
—
—
—
—
15
—
—
—
—
—
—
—
—
—
(3,533)
28,613
88,320
—
21,038
—
5,536
—
—
—
—
—
—
(4,454)
(4,454)
—
—
—
(3,518)
28,613
88,320
—
21,038
—
5,536
Balance, December 31, 2015
72,926 $
729 $
(2,157) $ 504,077 $ 570,223 $
(10,463)
$1,062,409
Net loss
Other comprehensive income:
Currency translation adjustment
Exercises of stock options, issuances of restricted stock
and sales of common stock under ESPP
Share-based compensation
Tax expense related to exercises of stock options and
vestings of restricted stock
—
—
—
—
(472,031)
—
(472,031)
—
1,022
—
—
—
10
—
—
—
—
—
—
(612)
32,180
—
(589)
—
—
—
—
2,607
2,607
—
—
(602)
32,180
—
(589)
Balance, December 31, 2016
73,948 $
739 $
(2,157) $ 535,056 $
98,192 $
(7,856)
$ 623,974
The accompanying notes are an integral part of these consolidated financial statements.
F-6
IMPAX LABORATORIES, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Years Ended December 31,
2016
2015
2014
$
(472,031) $
38,997 $
57,353
Cash flows from operating activities:
Net (loss) income
Adjustments to reconcile net (loss) income to net cash provided by operating activities:
Depreciation and amortization
Non-cash interest expense
Share-based compensation expense
Tax expense (benefit) from employees’ exercises of stock options and vestings of restricted
stock awards
Deferred income taxes, net and uncertain tax positions
Intangible asset impairment charges
Accrued profit sharing and royalty expenses, net of payments
Reserve for Turing receivable
Gain on sale of asset
Loss on debt extinguishment
Net change in fair value of derivatives
Recognition of deferred revenue
Other
Changes in certain assets and liabilities:
Accounts receivable
Inventory
Prepaid expenses and other assets
Accounts payable and accrued expenses
Other liabilities
Net cash provided by operating activities
Cash flows from investing activities:
Payment for business acquisition (prior year net of cash acquired)
Purchases of property, plant and equipment
Proceeds from sales of property, plant and equipment
Payments for licensing agreements
Investment in cash surrender value of insurance
Proceeds from repayment of Tolmar loan
Proceeds from sale of intangible assets
Maturities of short-term investments
Purchases of short-term investments
Net cash used in investing activities
Cash flows from financing activities:
Proceeds from sale of convertible notes
Proceeds from issuance of term loan
Repayment of term loan
Payment of deferred financing fees
Purchase of bond hedge derivative asset
Proceeds from sale of warrants
88,348
22,845
32,180
589
(127,405)
541,597
(52,083)
40,312
—
—
—
—
2,678
26,771
(45,561)
(573)
14,292
2,638
74,597
(585,800)
(49,402)
1,360
(3,500)
(4,750)
15,000
—
—
—
68,637
11,230
28,613
(5,536)
(29,558)
13,664
44,306
—
(45,574)
16,903
13,000
(4,310)
(81)
(121,110)
(14,035)
9,330
48,106
(656)
71,926
(691,348)
(25,199)
—
(5,850)
(4,750)
—
59,546
200,064
—
34,026
—
20,883
(3,317)
(11,810)
2,876
3,786
—
—
—
—
(3,939)
1,226
(33,497)
(16,338)
(9,952)
(8,980)
500
32,817
—
(29,913)
—
(13,000)
(3,000)
—
—
395,404
(366,092)
(16,601)
—
—
—
—
—
—
(627,092)
(467,537)
—
400,000
(5,000)
(11,867)
—
—
600,000
435,000
(435,000)
(36,941)
(147,000)
88,320
F-7
Tax (expense) benefit from employees’ exercises of stock options and vestings of restricted
stock awards
Proceeds from exercises of stock options and ESPP
Net cash provided by financing activities
(589)
9,239
391,783
5,536
11,472
521,387
3,317
11,097
14,414
Effect of exchange rate changes on cash and cash equivalents
494
(298)
(369)
Net (decrease) increase in cash and cash equivalents
Cash and cash equivalents, beginning of year
Cash and cash equivalents, end of year
Supplemental disclosure of cash flow information:
Cash paid for interest
Cash paid for income taxes, net
Supplemental disclosure of non-cash investing activity:
Fair value of contingent consideration issued in business acquisition
(160,218)
340,351
125,478
214,873
180,133 $
340,351 $
30,261
184,612
214,873
18,139 $
23,053 $
15,365 $
43,223 $
17
72,174
30,100 $
— $
—
$
$
$
$
The accompanying notes are an integral part of these consolidated financial statements.
F-8
1. DESCRIPTION OF BUSINESS
IMPAX LABORATORIES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Impax Laboratories, Inc. (“Impax” or the “Company”) is a specialty pharmaceutical company that focuses on developing, manufacturing, marketing and
distributing generic and branded pharmaceutical products. The Company has two reportable segments, referred to as “Impax Generics” and “Impax Specialty
Pharma.” The Impax Generics division focuses on a broad range of therapeutic areas, including products having technically challenging drug-delivery mechanisms
or unique product formulations. In addition to developing solid oral dosage products, the Impax Generic division’s portfolio includes alternative dosage form
products, primarily through alliance and collaboration agreements with third parties. The Company’s Impax Specialty Pharma division is focused on the
development and promotion, through the Company’s specialty sales force, of proprietary branded pharmaceutical products for the treatment of central nervous
system (“CNS”) disorders and other select specialty segments.
Operating and Reporting Structure
The Company currently operates in two divisions: the Impax Generics division and the Impax Specialty Pharma division. The Impax Generics division
includes the Company’s legacy Global Pharmaceuticals business as well as the acquired businesses of CorePharma, LLC ("CorePharma") and Lineage
Therapeutics, Inc. ("Lineage") from the Company's acquisition of Tower Holdings, Inc. ("Tower") and its subsidiaries on March 9, 2015 (the "Tower
Acquisition"). The Impax Specialty Pharma division includes the legacy Impax Pharmaceuticals business as well as the acquired business of Amedra
Pharmaceuticals, LLC ("Amedra") from the Tower Acquisition.
Impax Generics develops, manufactures, sells, and distributes generic pharmaceutical products primarily through the following four sales channels: the
“Impax Generics” sales channel, for generic pharmaceutical prescription products the Company sells directly to wholesalers, large retail drug chains, and others;
the “Private Label” sales channel, for generic pharmaceutical over-the-counter (“OTC”) and prescription products the Company sells to unrelated third-party
customers who, in turn, sell the product to third parties under their own label; the “Rx Partner” sales channel, for generic prescription products sold through
unrelated third-party pharmaceutical entities under their own label pursuant to alliance agreements; and the “OTC Partner” sales channel, for generic
pharmaceutical OTC products sold through unrelated third-party pharmaceutical entities under their own labels pursuant to alliance and supply agreements.
Revenues from the “Impax Generics” sales channel and the “Private Label” sales channel are reported under the caption “Impax Generics sales, net” in “Note 24.
Supplementary Financial Information.” Revenues from the “OTC Partner” sales channel are reported under the caption “Other Revenues” in “Note 24.
Supplementary Financial Information.”
Impax Specialty Pharma is engaged in the development, sale and distribution of proprietary brand pharmaceutical products that the Company believes
represent improvements to already-approved pharmaceutical products addressing CNS disorders and other select specialty segments. Impax Specialty Pharma
currently has one internally developed branded pharmaceutical product, Rytary® (IPX066), an extended release oral capsule formulation of carbidopa-levodopa for
the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese
intoxication, which was approved by the FDA on January 7, 2015 and which the Company began marketing in the United States (“U.S.”) in April 2015. The
Company received marketing authorization from the European Commission for Numient® (the brand name of IPX066 outside of the United States) during the
fourth quarter of fiscal year 2015. In addition to Rytary®, Impax Specialty Pharma is also currently engaged in the sale and distribution of four other branded
products; the more significant include Zomig® (zolmitriptan) products, indicated for the treatment of migraine headaches, under the terms of a Distribution,
License, Development and Supply Agreement with AstraZeneca UK Limited (“AstraZeneca”) in the United States and in certain U.S. territories (the "AZ
Agreement"), and Emverm® (mebendazole) 100 mg chewable tablets, indicated for the treatment of pinworm, whipworm, common roundworm, common
hookworm, and American hookworm in single or mixed infections. Revenues from Impax-labeled branded products are reported under the caption “Impax
Specialty Pharma sales, net” in “Note 24. Supplementary Financial Information.” Finally, the Company generated revenue in Impax Specialty Pharma from
research and development services provided under a development and license agreement with another unrelated third-party pharmaceutical company (which was
terminated by mutual agreement of the parties effective December 23, 2015), and reports such revenue under the caption “Other Revenues” in “Note 24.
Supplementary Financial Information.” Impax Specialty Pharma also has a number of product candidates that are in varying stages of development. See “Note 23.
Segment Information,” for financial information about our segments for the years ended December 31, 2016 , 2015 and 2014 .
F-9
Operating Locations
The Company owns and/or leases facilities in California, Pennsylvania, New Jersey and Taiwan, Republic of China (“R.O.C.”). In California, the
Company utilizes a combination of owned and leased facilities mainly located in Hayward. The Company’s primary properties in California consist of a leased
office building used as the Company’s corporate headquarters, in addition to five properties it owns, including a research and development center facility and a
manufacturing facility. Additionally, the Company leases two facilities in Hayward, utilized for additional research and development, equipment storage and
quality assurance support. In Pennsylvania, the Company leased facilities in Chalfont, Montgomeryville, and Horsham used for sales and marketing, finance, and
administrative personnel. During September 2016, the Company consolidated the three Pennsylvania locations into a new leased facility located in Fort
Washington, Pennsylvania. In addition, the Company previously owned a packaging plant in Philadelphia, Pennsylvania that was closed and sold in February 2016
in conjunction with the Company's restructuring of its packaging and distribution operations announced in June 2015 and discussed below in "Note 18.
Restructurings." In New Jersey, the Company leases manufacturing, packaging, research and development and warehousing facilities in Middlesex, New Jersey
and office space in Bridgewater, New Jersey. Outside the United States, in Taiwan, R.O.C., the Company owns a manufacturing facility.
Management Changes
On December 20, 2016, the Company announced that G. Frederick Wilkinson and the Company had mutually agreed that Mr. Wilkinson separate from
his positions as President and Chief Executive Officer and resign as a member of the Board of Directors (the “Board”) of the Company, effective December 19,
2016. In connection with his separation from the Company, Mr. Wilkinson and the Company entered into a General Release and Waiver dated as of December 19,
2016 (the “General Release and Waiver”). Pursuant to the General Release and Waiver, the Company provided Mr. Wilkinson with certain termination benefits
and payments. The Company recorded $5.4 million in costs associated with Mr. Wilkinson’s separation in the year ended December 31, 2016, comprised of $4.9
million of separation pay and benefits and $0.5 million of expense related to the accelerated vesting of certain of Mr. Wilkinson’s outstanding stock options and
restricted stock awards pursuant to the terms of the General Release and Waiver. Refer to “Note 16. Share-based Compensation” for more information on the
acceleration of Mr. Wilkinson’s equity awards. On December 19, 2016, the Company appointed J. Kevin Buchi, a director on the Company's Board, as Interim
President and Chief Executive Officer while the Board conducts a search for a permanent President and Chief Executive Officer.
On August 1, 2016, the Company announced that Douglas S. Boothe joined the Company as President of the Generics Division. Mr. Boothe reports
directly to the Chief Executive Officer, and is responsible for all aspects of the Company's Generics business. In connection with his appointment as President of
the Generics Division of the Company, Mr. Boothe and the Company entered into an Employment Agreement dated July 14, 2016 (the “Employment
Agreement”). The initial term of the Employment Agreement expires on August 1, 2018, unless further extended or earlier terminated as provided in the
Employment Agreement. The Employment Agreement automatically renews for single one -year periods unless either party provides at least 90 days written notice
of non-renewal prior to the end of the applicable term or unless it is terminated earlier.
On October 22, 2014, the Company announced that Carole S. Ben-Maimon, M.D., then President of the Company’s Generics Division, informed the
Company of her decision to retire from her position effective November 3, 2014. In connection with her retirement, Dr. Ben-Maimon entered into a Separation
Agreement with the Company dated October 22, 2014 which provided Dr. Ben-Maimon with $1.9 million of certain termination benefits and payments that were
recorded during the fourth quarter of 2014.
During the three month period ended March 31, 2014, the Company announced that the Company’s then Senior Vice President, Global Operations
announced plans to retire and a Senior Vice President, Technical Operations was appointed. The Company’s then Senior Vice President, Global Operations
subsequently retired from the Company in July 2014. In conjunction with the transition, the Company recorded $0.9 million in separation charges and accelerated
share-based compensation expense in the six month period ended June 30, 2014.
F-10
2. BUSINESS ACQUISITIONS
Teva Transaction
On August 3, 2016, the Company completed its previously announced acquisition of (A) certain assets related to (i) 15 currently marketed generic
pharmaceutical products, (ii) one approved generic product and two tentatively approved strengths of a currently marketed product, which have not yet launched,
(iii) one pipeline generic product and one pipeline strength of a currently marketed product, which are pending approval by the FDA and (iv) one generic product
under development, and (B) the return to the Company of its full commercial rights to its pending ANDA for the generic equivalent to Concerta®
(methylphenidate hydrochloride), a product the Company previously partnered with Teva Pharmaceuticals USA, Inc. (“Teva USA”) (collectively, the products and
pipeline products and the assets related thereto in (A) and (B), the “Acquired Product Lines” and the transactions related thereto the “Teva Transaction”), pursuant
to (x) an Asset Purchase Agreement, dated as of June 20, 2016, as amended on June 30, 2016, with Teva Pharmaceutical Industries Ltd. (“Teva”), acting directly or
through its affiliates (the “Teva APA”), (y) an Asset Purchase Agreement, dated as of June 20, 2016, as amended on June 30, 2016, with affiliates of Allergan plc
(“Allergan”), (the “Allergan APA” and collectively with the Teva APA, the "APAs"), and (z) a Termination Agreement, dated as of June 20, 2016, between the
Company and Teva USA, terminating each party’s rights and obligations with respect to methylphenidate hydrochloride under the Strategic Alliance Agreement,
dated June 27, 2001, as amended between the Company and Teva USA. The aggregate purchase price for the Acquired Product Lines pursuant to the terms of the
Teva APA and the Allergan APA, including the upfront payment to Teva in accordance with the Termination Agreement, was $585.8 million in cash at closing.
The Company is also obligated to make future payments to Teva of up to $40.0 million under the terms of the Termination Agreement, payable upon the
achievement of specified commercialization events related to methylphenidate hydrochloride. The Teva Transaction was part of the divestiture process mandated
by the Federal Trade Commission in connection with the acquisition by Teva of the U.S. generics business of Allergan.
The Company financed the Teva Transaction utilizing cash on hand and $400.0 million , the full amount of borrowing available, from its Term Loan
Facility with Royal Bank of Canada, as discussed in "Note 13. Debt." The Company incurred acquisition-related costs for the Teva Transaction of $3.7 million , of
which $3.1 million and $0.6 million was included in selling, general and administration expenses in the Company's consolidated statements of operations for the
years ended December 31, 2016 and 2015, respectively.
The acquisition of the foregoing currently marketed and pipeline products fits with the Company’s strategic priorities of maximizing its Generics
Division’s platform and optimizing research and development opportunities. Through the Teva Transaction, the Company expects to expand its portfolio of
difficult-to-manufacture or limited-competition products and maximize utilization of its existing manufacturing facilities in Hayward, California and Taiwan.
As part of the closing of the Teva Transaction, the Company, Teva and Allergan agreed to certain transition related services pursuant to which the
Company agreed to manage the payment process for certain commercial chargebacks and rebates on behalf of Teva and Allergan related to products each of Teva
and Allergan sold into the channel prior to the closing date. On August 18, 2016, the Company received a payment totaling $42.4 million from Teva and Allergan,
which represented their combined estimate of the amount of commercial chargebacks and rebates to be paid by the Company on their behalf to wholesalers who
purchased products from Teva and Allergan prior to the closing. Pursuant to the agreed upon transition services, Teva and Allergan are obligated to reimburse the
Company for additional payments related to chargebacks and rebates made on their behalf in excess of the $42.4 million . If the total payments made by the
Company on behalf of Teva and Allergan are less than $42.4 million , the Company is obligated to refund the difference to Teva and/or Allergan. As of
December 31, 2016 , the Company had paid $27.6 million on behalf of Teva and Allergan related to chargebacks and rebates as described above and $14.8 million
remained in accrued expenses on the consolidated balance sheet.
F-11
Purchase Accounting and Consideration
Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 805, Business Combinations ("ASC 805") defines a
business as consisting of inputs and processes applied to those inputs that have the ability to create outputs. The Company has determined that the Acquired
Product Lines meet the definition of a business and, accordingly, has accounted for the Teva Transaction as a business combination under the acquisition method
of accounting.
The following is a preliminary estimate of the purchase price for the Teva Transaction as of the closing date of August 3, 2016 (in thousands):
Purchase price per the APAs
Upfront payment pursuant to Termination Agreement
Total cash consideration
Fair value of contingent consideration pursuant to Termination Agreement
(1)
Total consideration transferred
Estimated Fair
Value
$
$
575,800
10,000
585,800
30,100
615,900
(1) The contingent consideration arrangement pursuant to the Termination Agreement potentially requires the Company to pay up to $40.0 million of
additional consideration to Teva upon the achievement of specified commercialization events related to methylphenidate hydrochloride. The $30.1
million fair value of the potential contingent consideration payments recognized on the acquisition date was estimated by applying a probability-
weighted expected return methodology.
Recognition and Measurement of Assets Acquired at Fair Value
The Company has preliminarily allocated the purchase price for the Teva Transaction based upon the estimated fair value of the assets acquired at the date
of acquisition. Accordingly, the preliminary purchase price allocation described below is subject to change. The Company expects to finalize the allocation of
purchase price upon receipt of the final valuations for the intangible assets. Any adjustments to the preliminary fair values will be made as soon as practicable but
no later than one year from the August 3, 2016 closing date of the Teva Transaction.
The following is a preliminary estimate of the fair value of the intangible and tangible assets acquired in connection with the Teva Transaction on the
closing date of August 3, 2016 (in thousands):
Intangible assets
Inventory - raw materials
Total assets acquired
F-12
Estimated Fair
Value
$
$
613,032
2,868
615,900
Intangible Assets
The following identifies the Company’s preliminary allocations of purchase price to intangible assets, including the weighted-average amortization
period, in total and by major intangible asset class as of the closing date. See also "Note 11. Intangible Assets and Goodwill" for a discussion on non-cash
impairment charges recorded during the third and fourth quarters of 2016 related to the intangible assets acquired in the Teva Transaction (in thousands):
Estimated Fair
Value
Weighted-Average
Estimated Useful Life
Marketed product rights
Acquired IPR&D product rights (1)
Total intangible assets
$
$
455,529
157,503
613,032
19 years
n/a
(1) "IPR&D" refers to the Company's in-process research and development product rights. Pursuant to the Termination Agreement, Teva returned to the
Company its full commercial rights to its pending ANDA for the generic equivalent to Concerta ® (methylphenidate hydrochloride), a product the
Company previously partnered with Teva USA under a Strategic Alliance Agreement dated June 27, 2001, as amended. As a result, the Company
recognized an intangible asset of $78.9 million related to the reacquired IPR&D. The Company engaged a third-party valuation specialist to measure
the value of the reacquired product right using a discounted cash flow analysis. The asset was determined to be indefinite-lived based on the market
participant methodology prescribed in ASC 805.
The estimated fair value of the in-process research and development and identifiable intangible assets was determined using the “income approach,”
which is a valuation technique that provides an estimate of the fair value of an asset based on market participant expectations of the cash flows an asset would
generate over its remaining useful life. The assumptions, including the expected projected cash flows, utilized in the preliminary purchase price allocation and in
determining the purchase price were based on management's best estimates as of the closing date of the Teva Transaction on August 3, 2016. Some of the more
significant assumptions inherent in the development of those asset valuations include the estimated net cash flows for each year for each asset or product (including
net revenues, cost of sales, research and development costs, selling and marketing costs and working capital / contributory asset charges), the appropriate discount
rate to select in order to measure the risk inherent in each future cash flow stream, the assessment of each asset’s life cycle, the potential regulatory and commercial
success risks, competitive trends impacting the asset and each cash flow stream, as well as other factors. The discount rates used to arrive at the present value at the
closing date of the intangible assets was 6.7% . No assurances can be given that the underlying assumptions used to prepare the discounted cash flow analysis will
not change. For these and other reasons, actual results may vary significantly from estimated results. As described in "Note 11. Intangible Assets and Goodwill,"
the Company recorded non-cash impairment charges during the year ended December 31, 2016 in the amount of $308.4 million related to the intangible assets
from the Teva Transaction.
Revenues and Earnings for Acquired Product Lines
Included in the Company's consolidated statement of operations for the year ended December 31, 2016 were revenues of $44.8 million and a net loss of
$244.7 million (including $308.4 million of impairment charges - See "Note 11. Intangible Assets and Goodwill"), representing the results of operations for the
Acquired Product Lines from the Teva Transaction from the August 3, 2016 closing date through December 31, 2016 .
F-13
Unaudited Pro Forma Results of Operations
The unaudited pro forma combined results of operations for the years ended December 31, 2016 and 2015 (assuming the closing of the Teva Transaction
occurred on January 1, 2015) are as follows (in thousands):
Years Ended December 31,
2016
2015
Total revenues
$
Net (loss) income
927,593 $
(450,190)
1,025,598
70,057
The pro forma adjustments reflected herein include only those adjustments that are directly attributable to the Teva Transaction, factually supportable and
expected to have a continuing impact on the Company. The pro forma results have been prepared for comparative purposes only and are not necessarily indicative
of the actual results of operations had the closing of the Teva Transaction taken place on January 1, 2015. Furthermore, the pro forma results do not purport to
project the future results of operations of the Company.
The unaudited pro forma information reflects primarily the following adjustments:
•
•
•
Adjustments to amortization expense related to identifiable intangible assets acquired;
Adjustments to interest expense to reflect the Company's Term Loan Facility (described in “Note 13. Debt”); and
Adjustments to selling, general and administrative expense related to transaction costs directly attributable to the transaction include the elimination
of $3.1 million of charges in the pro forma results for the year ended December 31, 2016 which have been included in the pro forma results for
the year ended December 31, 2015.
All of the items above were adjusted for the applicable tax impact.
Tower Acquisition
On March 9, 2015, the Company completed the Tower Acquisition for a purchase price of $691.3 million , net of $41.5 million of cash acquired and
including the repayment of indebtedness of Tower and Lineage and post-closing working capital adjustments. The privately-held companies specialized in the
development, manufacture and commercialization of complex generic and branded pharmaceutical products. The Tower Acquisition included the Company's
acquisition of all of the outstanding shares of common stock of Tower and Lineage, pursuant to the Stock Purchase Agreement dated as of October 8, 2014, by and
among the Company, Tower, Lineage, Roundtable Healthcare Partners II, L.P., Roundtable Healthcare Investors II, L.P., and the other parties thereto, including
holders of certain options and warrants to acquire the common stock of Tower or Lineage. In connection with the Tower Acquisition, the options and warrants of
Tower and Lineage that were outstanding at the time of the acquisition were cancelled. The Company incurred acquisition-related costs of $10.9 million , of which
$6.7 million were incurred during the year ended December 31, 2015 and were included in selling, general and administrative expenses in the Company's
consolidated statement of operations for that period. In connection with the Tower Acquisition, the Company recorded an accrual for severance and related
termination costs of $2.4 million during 2015 related to the elimination of approximately 10 positions at the acquired companies. The Company paid all severance
and related termination costs related to the Tower Acquisition as of the end of the second quarter of 2016.
The Tower Acquisition allowed the Company to expand its commercialized generic and branded product portfolios. The Company has also leveraged its
sales and marketing organization to promote the marketed products acquired.
Consideration
The Company has accounted for the Tower Acquisition as a business combination under the acquisition method of accounting. The Company allocated
the purchase price for the transaction based upon the fair value of net assets acquired and liabilities assumed at the date of acquisition.
F-14
Recognition and Measurement of Assets Acquired and Liabilities Assumed at Fair Value
The following tables summarize the final fair values of the tangible and identifiable intangible assets acquired and liabilities assumed in the Tower
Acquisition at the closing date, net of cash acquired of $41.5 million (in thousands):
Accounts receivable (1)
Inventory
Income tax receivable and other prepaid expenses
$
Property, plant and equipment
Intangible assets
Intangible assets held for sale
Goodwill
Deferred income taxes
Other non-current assets
Total assets acquired
Current liabilities
Deferred tax liabilities
Other non-current liabilities
Total liabilities assumed
56,851
31,259
2,407
27,540
632,600
4,000
179,755
37,041
3,844
975,297
67,584
210,005
6,360
283,949
Cash paid, net of cash acquired
$
691,348
(1) The accounts receivable acquired in the Tower Acquisition had a fair value of $56.9 million , including an allowance for doubtful accounts of $9.0
million , which represented the Company’s best estimate on March 9, 2015 (the closing date of the transaction) of the contractual cash flows not
expected to be collected by the acquired companies.
Intangible Assets
The following table identifies the Company’s allocations, by category, of the Tower Acquisition purchase price to the intangible assets acquired as of the
closing date (in thousands):
Estimated Fair
Value
Weighted-Average
Estimated Useful
Life (years)
Marketed product rights
Royalty rights
Acquired IPR&D product rights
Total intangible assets
$
$
381,100
80,800
170,700
632,600
13
12
n/a
The estimated fair value of the in-process research and development and identifiable intangible assets was determined using the “income approach,”
which is a valuation technique that provides an estimate of the fair value of an asset based on market participant expectations of the cash flows an asset would
generate over its remaining useful life. Some of the more significant assumptions inherent in the development of those asset valuations include the estimated net
cash flows for each year for each asset or product (including net revenues, cost of sales, research and development costs, selling and marketing costs and working
capital / contributory asset charges), the appropriate discount rate to select in order to measure the risk inherent in each future cash flow stream, the assessment of
each asset’s life cycle, the potential regulatory and commercial success risks, competitive trends impacting the asset and each cash flow stream as well as other
factors. The discount rates used to arrive at the present value at the acquisition date of currently marketed products was 15% . For in-process research and
development, the discount rate used was 16% to reflect the internal rate of return and incremental commercial uncertainty in the cash flow projections. No
assurances can be given that the underlying assumptions used to prepare the discounted cash flow analysis will not change. For these and other reasons, actual
results may vary significantly from estimated results.
F-15
Goodwill
The Company recorded approximately $179.8 million of goodwill in connection with the Tower Acquisition, some of which will not be tax-deductible.
Goodwill of $59.7 million was assigned to the Impax Specialty Pharma segment and $120.1 million was assigned to the Impax Generics segment. Factors that
contributed to the Company’s recognition of goodwill include the Company’s intent to expand its generic and branded pharmaceutical product portfolios and to
acquire certain benefits from the Tower and Lineage product pipelines, in addition to the anticipated synergies that the Company expects to generate from the
acquisition.
Unaudited Pro Forma Results of Operations
The unaudited pro forma combined results of operations for the years ended December 31, 2015 and 2014 (assuming the closing of the Tower Acquisition
occurred on January 1, 2014) are as follows (in thousands):
Year Ended December 31,
2015
Year Ended December 31,
2014
Total revenues
Net income
$
$
892,906 $
54,285 $
819,838
30,838
The pro forma adjustments reflected herein include only those adjustments that are directly attributable to the Tower Acquisition, factually supportable
and expected to have a continuing impact on the Company. The pro forma results have been prepared for comparative purposes only and are not necessarily
indicative of the actual results of operations had the closing of the Tower Acquisition taken place on January 1, 2014. Furthermore, the pro forma results do not
purport to project the future results of operations of the Company.
The unaudited pro forma information reflects primarily the following adjustments:
•
•
•
•
•
•
•
Adjustments to amortization expense related to identifiable intangible assets acquired;
Adjustments to depreciation expense related to property, plant and equipment acquired;
Adjustments to interest expense to reflect the long-term debt held by Tower and Lineage paid out and eliminated at the closing and the Company's
Senior Secured Credit Facilities (described in “Note 13. Debt”);
Adjustments to cost of revenues related to the fair value adjustments in inventory sold, including elimination of $6.1 million for the year ended
December 31, 2015 and additional costs of approximately $6.1 million for the year ended December 31, 2014;
Adjustments to selling, general and administrative expense related to severance and retention costs of $3.4 million incurred as part of the transaction.
These costs were eliminated in the pro forma results for the year ended December 31, 2015 and included in the pro forma results for the year ended
December 31, 2014;
Adjustments to selling, general and administrative expense related to transaction costs directly attributable to the transaction include the elimination
of $12.2 million of charges in the pro forma results for the year ended December 31, 2015 which have been included in the pro forma results for the
year ended December 31, 2014; and
Adjustments to reflect the elimination of $2.3 million in commitment fees related to the Company's $435.0 million term loan with Barclays Bank
PLC (described in "Note 13. Debt") that were incurred during the year ended December 31, 2015 and were included in the pro forma results for the
year ended December 31, 2014.
All of the items above were adjusted for the applicable tax impact.
F-16
3. BASIS OF PRESENTATION
Principles of Consolidation
The consolidated financial statements of the Company include the accounts of the operating parent company, Impax Laboratories, Inc., its wholly owned
subsidiaries, including Impax Laboratories USA, LLC, Impax Laboratories (Taiwan), Inc., ThoRx Laboratories, Inc., Impax International Holding, Inc., Impax
Holdings, LLC, Impax Laboratories (Netherlands) C.V., Impax Laboratories (Netherlands) B.V., Impax Laboratories Ireland Limited, Lineage and Tower,
including operating subsidiaries CorePharma, Amedra Pharmaceuticals, Mountain LLC and Trail Services, Inc., in addition to an equity investment in Prohealth
Biotech (Taiwan), Inc. (“Prohealth”), in which the Company held a 57.54% majority ownership interest at December 31, 2016 . All significant intercompany
accounts and transactions have been eliminated.
Foreign Currency Translation
The Company translates the assets and liabilities of the Taiwan dollar functional currency of its majority-owned affiliate Prohealth and its wholly-owned
subsidiary Impax Laboratories (Taiwan), Inc. into the U.S. dollar reporting currency using exchange rates in effect at the end of each reporting period. The
revenues and expenses of these entities are translated using an average of the rates in effect during the reporting period. Gains and losses from these translations are
recorded as currency translation adjustments included in the consolidated statements of comprehensive (loss) income and the consolidated statements of changes in
stockholders’ equity.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”) and the rules and
regulations of the U.S. Securities & Exchange Commission (“SEC”) requires the use of estimates and assumptions, based on complex judgments considered
reasonable, which affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the consolidated
financial statements and the reported amounts of revenues and expenses during the reporting period. The most significant judgments are employed in estimates
used in determining values of tangible and intangible assets, contingent consideration, legal contingencies, tax assets and tax liabilities, fair value of share-based
compensation related to equity incentive awards issued to employees and directors, and estimates used in applying the Company’s revenue recognition policy,
including those related to accrued chargebacks, rebates, product returns, Medicare, Medicaid, and other government rebate programs, shelf-stock adjustments, and
the timing and amount of deferred and recognized revenue and deferred and amortized product manufacturing costs related to alliance and collaboration
agreements. Actual results may differ from estimated results.
Reclassifications
Certain prior year amounts have been reclassified to conform to the presentation for the year ended December 31, 2016 .
4. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Cash and Cash Equivalents
The Company considers all short-term investments with a maturity of three months or less at the date of purchase to be cash equivalents. Cash and cash
equivalents are stated at cost, which, for cash equivalents, approximates fair value due to the short-term nature. The Company is potentially subject to financial
instrument concentration of credit risk through its cash and cash equivalents.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentrations of credit risk are cash, cash equivalents and accounts receivable. Cash is held
on deposit in demand accounts at large financial institutions in amounts in excess of the Federal Deposit Insurance Corporation (FDIC) insurance coverage limit of
$250,000 per depositor, per FDIC-insured bank, per ownership category. Cash equivalents are comprised of highly-rated money market funds. The Company limits
its credit risk with respect to accounts receivable by performing credit evaluations of customers when deemed necessary. The Company does not require collateral
to secure amounts due from its customers.
F-17
The following tables present the percentage of total accounts receivable and gross revenues represented by the Company’s five largest customers as of
and for the years ended December 31, 2016 , 2015 and 2014 :
Percent of Total Accounts Receivable
2016
2015
2014
Customer #1
Customer #2
Customer #3
Customer #4
Customer #5
Customer #6
Customer #7
Customer #8
Total
Top five largest customers
36.2%
35.6%
20.5%
1.7%
0.7%
0.5%
0.5%
0.3%
96.0%
94.7%
52.4%
24.8%
14.4%
0.7%
0.1%
1.0%
0.6%
0.5%
94.5%
93.3%
Percent of Gross Revenues
2016
2015
2014
Customer #1
Customer #2
Customer #3
Customer #4
Customer #5
Customer #6
Total
Top five largest customers
40.1%
28.4%
20.1%
1.2%
1.1%
0.4%
91.3%
90.9%
45.6%
21.7%
18.8%
1.1%
1.4%
0.4%
89.0%
88.6%
36.9%
28.2%
19.6%
0.6%
1.6%
1.8%
1.7%
1.7%
92.1%
88.2%
36.0%
20.7%
19.3%
1.8%
2.5%
1.9%
82.2%
80.4%
In July 2015, the Company received an unsolicited offer from Turing Pharmaceuticals AG (“Turing”) to purchase the U.S. rights to Daraprim®, one of
the marketed products acquired in the Tower Acquisition, as well as the active pharmaceutical ingredient for the product and the finished goods inventory on hand.
The sale closed on August 7, 2015, and the Company received proceeds of $55.5 million at closing. The net book value of the Daraprim® product rights at the time
of sale was $9.3 million , and the Company recognized a gain on the sale of the intangible asset of $45.6 million , net of expenses. Pursuant to the terms of the
Asset Purchase Agreement between the Company and Turing dated August 7, 2015 (the “Turing APA”), the Company also granted a limited license to sell the
existing Daraprim® product under the Company’s labeler code with the Company’s trade dress.
In accordance with the terms of the Turing APA and in accordance with federal laws and regulations, the Company receives and is initially responsible
for processing and paying (subject to reimbursement by Turing), all chargebacks and rebates resulting from utilization by Medicaid, Medicare and other federal,
state and local governmental programs, health plans and other health care providers for product sold under the Company’s labeler code. Under the terms of the
Turing APA, Turing is responsible for liabilities related to chargebacks and rebates that arise as a result of Turing’s marketing or selling related activities in
connection with Daraprim®.
F-18
During the fourth quarter of 2015, the Company began receiving invoices for chargebacks from wholesalers and rebates from various state Medicaid
agencies for Daraprim® purchases made by governmental agencies during the third quarter of 2015. As a result, the Company recorded a $40.6 million receivable
from Turing as of December 31, 2015, representing actual invoices received related to the third quarter of 2015 and an estimate for invoices not yet received
related to the third and fourth quarters of 2015. During 2016, the Company received additional invoices related to the third and fourth quarters of 2015 and
recorded an estimate for invoices not yet received for 2016. In total, the Company recorded an additional $7.4 million receivable from Turing during the year
ended December 31, 2016 . During the fourth quarter of 2016, the Company received payment in the amount of $7.7 million from Turing, resulting in an estimated
accounts receivable balance due to the Company of $40.3 million as of December 31, 2016 , with over $35.7 million of such amount representing overdue unpaid
invoices due from Turing for chargebacks and Medicaid rebate liability as of December 31, 2016 . The Company has paid $33.5 million of cash on Turing's behalf
(net of the $7.7 million payment received from Turing) through December 31, 2016 and the remaining difference of $6.8 million (compared to the $40.3 million
receivable due from Turing) is included in "Accrued expenses" on the Company's consolidated balance sheet. As of February 17, 2017 , the amount of total
payments made by the Company on Turing’s behalf (net of the $7.7 million payment received from Turing) was $33.5 million .
As a result of the uncertainty of the Company collecting the reimbursement amounts owed by Turing that developed since the filing of the Company’s
Annual Report on Form 10-K for the fiscal year ended December 31, 2015 , the Company recorded a reserve in the amount of $48.0 million on the Company’s
consolidated statement of operations in "Other income (expense)" for the three month period ended March 31, 2016, representing the full amount of the estimated
receivable due from Turing as of March 31, 2016. During the fourth quarter of 2016, the Company received $7.7 million in payments from Turing, which reduced
the reserve balance to $40.3 million as of December 31, 2016 .
On May 2, 2016, the Company filed suit against Turing in the United States District Court for the Southern District of New York alleging breach of the
terms of the Turing APA seeking (i) a declaratory judgment that the Company may revoke Turing’s right to sell Daraprim® under the Company’s labeler code and
national drug codes; (ii) specific performance to require Turing to comply with its obligations under the Turing APA for past due reports and for reports going
forward; and (iii) money damages to remedy Turing’s failure to reimburse the Company for chargebacks and Medicaid rebate liability when due, currently in
excess of $35.7 million , and for future amounts that may be due. See “Note 22. Legal and Regulatory Matters” for a description of the Company’s suit against
Turing. If the Company receives an unfavorable outcome in its suit against Turing or if Turing for any reason does not, or is unable to, make its reimbursement
payments to the Company, it could have a material adverse effect on the Company’s business, results of operation and financial condition.
Allowance for Doubtful Accounts
The Company maintains allowances for doubtful accounts for estimated losses resulting from amounts deemed to be uncollectible from its customers;
these allowances are for specific amounts on certain accounts based on facts and circumstances determined on a case-by-case basis.
Inventory
Inventory is stated at the lower of cost or market. Cost is determined using a standard cost method, and the cost flow assumption is first in, first out
(“FIFO”) flow of goods. Standard costs are revised annually, and significant variances between actual costs and standard costs are apportioned to inventory and
cost of goods sold based upon inventory turnover. Costs include materials, labor, quality control, and production overhead. Inventory is adjusted for short-dated,
unmarketable inventory equal to the difference between the cost of inventory and the estimated value based upon assumptions about future demand and market
conditions. If actual market conditions are less favorable than those projected by the Company, additional inventory write-downs may be required. Consistent with
industry practice, the Company may build pre-launch inventories of certain products which are pending required approval from the FDA and/or resolution of patent
infringement litigation, when, in the Company’s assessment, such action is appropriate to prepare for the anticipated commercial launch and FDA approval is
expected in the near term and /or the related litigation will be resolved in the Company’s favor. The Company accounts for all costs of idle facilities, excess freight
and handling costs, and wasted materials (spoilage) as a current period charge in accordance with U.S. GAAP.
F-19
Property, Plant and Equipment
Property, plant and equipment are recorded at cost. Maintenance and repairs are charged to expense as incurred and costs of improvements and renewals
are capitalized. Costs incurred in connection with the construction or major renovation of facilities, including interest directly related to such projects, are
capitalized as construction in progress. Depreciation is recognized using the straight-line method based on the estimated useful lives of the related assets, which are
generally 40 years for buildings, 10 to 15 years for building improvements, eight to 10 years for equipment, and four to 10 years for office furniture and equipment.
Land and construction-in-progress are not depreciated.
Intangible Assets
The Company’s intangible assets include both finite lived and indefinite-lived assets. Finite lived intangible assets, consisting of marketed product rights
and royalties received from product sales by the Company's third party partners, are amortized over the estimated useful life of the asset based on the pattern in
which the economic benefits are expected to be consumed or otherwise used up or, if that pattern is not readily determinable, on a straight-line basis. Indefinite-
lived intangible assets consist of acquired IPR&D product rights and acquired future royalty rights to be paid based on other companies’ net sales of products not
yet approved. IPR&D assets acquired in a business combination are considered indefinite-lived until the completion or abandonment of the associated research and
development efforts. Amortization over the estimated useful life will commence at the time of the respective product’s launch. If FDA approval to market the
product is not obtained, the Company will immediately expense the related capitalized cost.
Finite lived intangible assets are tested for impairment when events or changes in circumstances indicate that the carrying value of the asset may not be
recoverable. All of the Company's indefinite-lived intangible assets are tested for impairment at least annually during the fourth quarter of the fiscal year, or more
often if indicators of impairment are present. Impairment testing requires management to estimate the future undiscounted cash flows of an intangible asset using
assumptions believed to be reasonable, but which are unpredictable and inherently uncertain. Actual future cash flows may differ from the estimates used in the
impairment testing. The Company recognizes an impairment loss when and to the extent that the estimated fair value of an intangible asset is less than its carrying
value.
Goodwill
In accordance with FASB ASC Topic 350, " Goodwill and Other Intangibles ," rather than recording periodic amortization, goodwill is subject to an
annual assessment for impairment by applying a fair value based test. If the fair value of the reporting unit exceeds the reporting unit’s carrying value, including
goodwill, then goodwill is considered not impaired, making further analysis not required. The Company considers the Impax Generics division and the Impax
Specialty Pharma division operating segments to each be a reporting unit. The Company attributes $59.7 million of goodwill to the Impax Specialty Pharma
division and $147.6 million of goodwill to the Impax Generics division.
The Company concluded the carrying value of goodwill was no t impaired as of December 31, 2016 and 2015 as the fair value of the Impax Specialty
Pharma division and the Impax Generics division exceeded their carrying value at each date. The Company performs its annual goodwill impairment test in the
fourth quarter of each year. The Company estimated the fair value of the Impax Specialty Pharma division and the Impax Generics division using a discounted cash
flow model for both the reporting unit and the enterprise. In addition, on a quarterly basis, the Company performs a review of its business operations to determine
whether events or changes in circumstances have occurred which could have a material adverse effect on the estimated fair value of each reporting unit, and thus
indicate a potential impairment of the goodwill carrying value. If such events or changes in circumstances were deemed to have occurred, the Company would
perform an interim impairment analysis, which may include the preparation of a discounted cash flow model, or consultation with one or more valuation
specialists, to determine the impact, if any, on the Company’s assessment of the reporting unit’s fair value.
F-20
Derivatives
The Company generally does not use derivative instruments or engage in hedging activities in its ordinary course of business. Prior to June 30, 2015, the
Company had no derivative assets or liabilities and did not engage in any hedging activities. As a result of the Company’s June 30, 2015 issuance of the
convertible senior notes described in “Note 13. Debt”, the conversion option of the notes temporarily met the criteria for an embedded derivative liability which
required bifurcation and separate accounting. Concurrently with the issuance of the notes, the Company entered into a series of convertible note hedge and warrant
transactions which in combination are designed to reduce the potential dilution to the Company’s stockholders and/or offset the cash payments the Company is
required to make in excess of the principal amount upon conversion of the notes. See “Note 14. Stockholders’ Equity” for additional information regarding the note
hedge transactions and warrant transactions. While the warrants sold were classified as equity and recorded in additional paid-in capital, the call options purchased
were temporarily classified as a bond hedge derivative asset on the Company’s consolidated balance sheet. The Company engaged a third-party valuation firm with
expertise in valuing financial instruments to determine the fair value of the bond hedge derivative asset and conversion option derivative liability at each reporting
period. The Company’s consolidated balance sheets reflected the fair value of the derivative asset and liability as of the reporting date, and changes in the fair value
were reflected in current period earnings, as appropriate. As result of the amendment to the Company’s Restated Certificate of Incorporation to increase the
number of authorized shares of the Company's common stock discussed in “Note 14. Stockholders’ Equity,” both the derivative asset and liability were reclassified
to additional paid-in capital. The Company had no derivative assets or liabilities and did not engage in any hedging activities as of December 31, 2016 or 2015 .
Contingencies
In the normal course of business, the Company is subject to loss contingencies, such as legal proceedings and claims arising out of its business, covering a
wide range of matters, including, among others, patent litigation, stockholder lawsuits, and product and clinical trial liability. The Company records accruals for
such loss contingencies when it is probable a liability will have been incurred and the amount of loss can be reasonably estimated. The Company does not
recognize gain contingencies until realized. The Company records an accrual for legal costs in the period incurred. A discussion of contingencies is included in
“Note 21. Commitments and Contingencies” and “Note 22. Legal and Regulatory Matters”.
Deferred Financing Costs
The Company capitalizes direct costs incurred to obtain debt financing and amortizes these costs to interest expense using the effective interest method
over the term of the debt. These costs are recorded as a debt discount and the unamortized costs are netted against the related debt on the Company’s consolidated
balance sheets. For line-of-credit arrangements with no outstanding borrowing, the costs incurred to obtain the credit facility are amortized to interest expense
using the straight-line method over the term of the line-of-credit arrangement. The unamortized balance is included in other assets on the Company’s consolidated
balance sheets.
Revenue Recognition
The Company recognizes revenue when the earnings process is complete, which under SEC Staff Accounting Bulletin No. 104, Topic No. 13, “Revenue
Recognition” (“SAB 104”), is when revenue is realized or realizable and earned, there is persuasive evidence a revenue arrangement exists, delivery of goods or
services has occurred, the sales price is fixed or determinable, and collectability is reasonably assured.
The Company accounts for material revenue arrangements which contain multiple deliverables in accordance with FASB ASC Topic 605-25, Revenue
Recognition - Multiple Element Arrangements ("ASC 605-25"), which addresses the determination of whether an arrangement involving multiple deliverables
contains more than one unit of accounting. A delivered item within an arrangement is considered a separate unit of accounting only if both of the following criteria
are met:
•
•
the delivered item has value to the customer on a stand-alone basis; and
if the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered
probable and substantially in the control of the vendor.
F-21
Under ASC Topic 605-25, if both of the criteria above are not met, then separate accounting for the individual deliverables is not appropriate. Revenue
recognition for arrangements with multiple deliverables constituting a single unit of accounting is recognized generally over the greater of the term of the
arrangement or the expected period of performance, either on a straight-line basis or on a modified proportional performance method.
The Company accounts for milestones related to research and development activities in accordance with FASB ASC Topic 605-28, Revenue Recognition
- Milestone Method ("ASC 605-28"). ASC Topic 605-28 allows for the recognition of consideration, which is contingent on the achievement of a substantive
milestone, in its entirety in the period the milestone is achieved. A milestone is considered to be substantive if all of the following criteria are met:
•
•
•
the milestone is commensurate with either: (1) the performance required to achieve the milestone, or (2) the enhancement of the value of the delivered
items resulting from the performance required to achieve the milestone;
the milestone relates solely to past performance; and
the milestone payment is reasonable relative to all of the deliverables and payment terms within the agreement.
Impax Generics revenues, net, and Impax Specialty Pharma revenues, net
The Impax Generics revenues, net and Impax Specialty Pharma revenues, net include revenue recognized related to shipments of generic and branded
pharmaceutical products to the Company’s customers, primarily drug wholesalers and retail chains. Gross sales revenue is recognized at the time title and risk of
loss passes to the customer, which is generally when product is received by the customer. Net revenues may include deductions from the gross sales price related to
estimates for chargebacks, rebates and administrative fees, distribution service fees, returns, shelf-stock adjustments, and other pricing adjustments. The Company
records an estimate for these deductions in the same period when revenue is recognized. A description of each of these gross-to-net deductions follows.
•
Chargebacks
The Company has agreements establishing contract prices for certain products with certain indirect customers, such as retail pharmacy chains, group
purchasing organizations, managed care organizations, hospitals and government agencies who purchase products from drug wholesalers. The contract prices are
lower than the prices the customer would otherwise pay to the wholesaler, and the price difference is referred to as a chargeback, which generally takes the form of
a credit memo issued by the Company to reduce the invoiced gross selling price charged to the wholesaler. An estimated accrued provision for chargeback
deductions is recognized at the time of product shipment. The primary factors considered when estimating the provision for chargebacks are the average historical
chargeback credits given, the mix of products shipped, and the amount of inventory on hand at the major drug wholesalers with whom the Company does business.
The Company also monitors actual chargebacks granted and compares them to the estimated provision for chargebacks to assess the reasonableness of the
chargeback reserve at each quarterly balance sheet date.
•
Rebates and Administrative Fees
The Company maintains various rebate and administrative fee programs with its customers in an effort to maintain a competitive position in the
marketplace and to promote sales and customer loyalty. The rebates generally take the form of a credit memo to reduce the invoiced gross selling price charged to a
customer for products shipped. An estimated accrued provision for rebate deductions is recognized at the time of product shipment. The primary factors the
Company considers when estimating the provision for rebates are the average historical experience of aggregate payments issued, the mix of products shipped and
the historical relationship of rebates as a percentage of total gross product sales, the contract terms and conditions of the various rebate programs in effect at the
time of shipment, and the amount of inventory on hand at the major drug wholesalers with whom the Company does business. The Company also monitors actual
rebates granted and compares them to the estimated provision for rebates to assess the reasonableness of the rebate reserve at each quarterly balance sheet date.
•
Distribution Service Fees
The Company pays distribution service fees to several of its wholesaler customers related to sales of its Impax Products. The wholesalers are generally
obligated to provide the Company with periodic outbound sales information as well as inventory levels of the Company’s Impax Products held in their warehouses.
Additionally, the wholesalers have agreed to manage the variability of their purchases and inventory levels within specified days on hand limits. An accrued
provision for distribution service fees is recognized at the time products are shipped to wholesalers.
F-22
•
Returns
The Company allows its customers to return product if approved by authorized personnel in writing or by telephone with the lot number and expiration
date accompanying any request and if such products are returned within six months prior to or until twelve months following, the product’s expiration date. The
Company estimates and recognizes an accrued provision for product returns as a percentage of gross sales based upon historical experience. The product return
reserve is estimated using a historical lag period, which is the time between when the product is sold and when it is ultimately returned, and estimated return rates
which may be adjusted based on various assumptions including: changes to internal policies and procedures, business practices, commercial terms with customers,
and the competitive position of each product; the amount of inventory in the wholesale and retail supply chain; the introduction of new products; and changes in
market sales information. The Company also considers other factors, including significant market changes which may impact future expected returns, and actual
product returns. The Company monitors actual returns on a quarterly basis and may record specific provisions for returns it believes are not covered by historical
percentages.
•
Shelf-Stock Adjustments
Based upon competitive market conditions, the Company may reduce the selling price of certain Impax Generics division products. The Company may
issue a credit against the sales amount to a customer based upon their remaining inventory of the product in question, provided the customer agrees to continue to
make future purchases of product from the Company. This type of customer credit is referred to as a shelf-stock adjustment, which is the difference between the
initial sales price and the revised lower sales price, multiplied by an estimate of the number of product units on hand at a given date. Decreases in selling prices are
discretionary decisions made by the Company in response to market conditions, including estimated launch dates of competing products and declines in market
price. The Company records an estimate for shelf-stock adjustments in the period it agrees to grant such a credit memo to a customer.
•
Cash Discounts
The Company offers cash discounts to its customers, generally 2% to 3% of the gross selling price, as an incentive for paying within invoice terms, which
generally range from 30 to 90 days. An estimate of cash discounts is recorded in the same period when revenue is recognized.
• Medicaid and Other U.S. Government Pricing Programs
As required by law, the Company provides a rebate on drugs dispensed under the Medicaid program, Medicare Part D, TRICARE, and other U.S.
government pricing programs. The Company determines its estimated government rebate accrual primarily based on historical experience of claims submitted by
the various states and other jurisdictions and any new information regarding changes in the various programs which may impact the Company’s estimate of
government rebates. In determining the appropriate accrual amount, the Company considers historical payment rates and processing lag for outstanding claims and
payments. The Company records estimates for government rebates as a deduction from gross sales, with a corresponding adjustment to accrued liabilities.
•
Rx Partner and OTC Partner
The Rx Partner and OTC Partner contracts include revenue recognized under alliance and collaboration agreements between the Company and unrelated
third-party pharmaceutical companies. The Company has entered into these alliance agreements to develop marketing and/or distribution relationships with its
partners to fully leverage its technology platform.
The Rx Partners and OTC Partners alliance agreements obligate the Company to deliver multiple goods and/or services over extended periods. Such
deliverables include manufactured pharmaceutical products, exclusive and semi-exclusive marketing rights, distribution licenses, and research and development
services. In exchange for these deliverables the Company receives payments from its agreement partners for product shipments and research and development
services, and may also receive other payments including royalties, profit sharing payments, and upfront and periodic milestone payments. Revenue received from
the alliance agreement partners for product shipments under these agreements is not subject to deductions for chargebacks, rebates, product returns, and other
pricing adjustments. Royalty and profit sharing amounts the Company receives under these agreements are calculated by the respective agreement partner, with
such royalty and profit share amounts generally based upon estimates of net product sales or gross profit which include estimates of deductions for chargebacks,
rebates, product returns, and other adjustments the alliance agreement partners may negotiate with their respective customers. The Company records the agreement
partner's adjustments to such estimated amounts in the period the agreement partner reports the amounts to the Company.
F-23
The Company applies the updated guidance of ASC 605-25 to the Strategic Alliance Agreement, as amended with Teva Pharmaceuticals USA , Inc., an
affiliate of Teva Pharmaceutical Industries Limited (the “Teva Agreement”). The Company looks to the underlying delivery of goods and/or services which give
rise to the payment of consideration under the Teva Agreement to determine the appropriate revenue recognition. The Company initially defers consideration
received as a result of research and development-related activities performed under the Teva Agreement. The Company recognizes deferred revenue on a straight-
line basis over the expected period of performance for such services. Consideration received as a result of the manufacture and delivery of products under the Teva
Agreement is recognized at the time title and risk of loss passes to the customer, which is generally when product is received by Teva. The Company recognizes
profit share revenue in the period earned.
OTC Partner revenue is related to agreements with Pfizer, Inc., formerly Wyeth LLC (“Pfizer”) and L. Perrigo Company (“Perrigo”) with respect to the
supply of the Company's over-the-counter pharmaceutical product Loratadine and Pseudoephedrine Sulfate 5 mg/120 mg 12-hour Extended Release Tablets (the
"D12 Product"). The OTC Partner sales channel is no longer a core area of the business, and the over-the-counter pharmaceutical products the Company sells
through this sales channel are older products which are now only sold to Pfizer and Perrigo. The Company is currently only required to manufacture the over-the-
counter pharmaceutical products under its agreements with Pfizer and Perrigo. The Company recognizes profit share revenue in the period earned. During the
quarter ended September 30, 2016, the Company sold the ANDAs for both the D12 Product and the Loratadine and Pseudoephedrine Sulfate 10 mg/240 mg 24-
hour Extended Release Tablets, in addition to other specified assets, to Perrigo pursuant to an asset purchase agreement with Perrigo dated as of March 31, 2016
(the "Perrigo APA"). Under the terms of the Perrigo APA, the Company will also continue to supply the D-12 Product to Pfizer and Perrigo until the date that is the
earliest of (i) the date Perrigo’s manufacturing facility is approved to manufacture the D-12 Product and (ii) December 31, 2017 (the "Supply End Date"). On the
Supply End Date, the Company will assign and transfer its supply agreement with Pfizer in its entirety to Perrigo in accordance with the Perrigo APA.
•
Research Partner
The Research Partner contract revenue results from development agreements the Company enters into with unrelated third-party pharmaceutical
companies. The development agreements generally obligate the Company to provide research and development services over multiple periods. In exchange for this
service, the Company generally receives upfront payments upon signing of each development agreement and is eligible to receive contingent milestone payments,
payment of which is based upon the achievement of contractually specified events. Additionally, the Company may also receive royalty payments from the sale, if
any, of a successfully developed and commercialized product under one of these development agreements. The Company recognizes revenue received from the
achievement of contingent research and development milestones in the period such payment is earned. Royalty revenue, if any, will be recognized as current period
revenue when earned.
Shipping and Handling Fees and Costs
Shipping and handling fees related to sales transactions are recorded as selling expense. Shipping costs were $3.7 million , $2.3 million and $2.4 million
for the years ended December 31, 2016 , 2015 and 2014 , respectively.
Research and Development Expenses
Research and development activities are expensed as incurred and consist of self-funded research and development costs and costs associated with work
performed by other participants under collaborative research and development agreements.
Share-Based Compensation
The Company accounts for stock-based employee compensation arrangements in accordance with provisions of FASB ASC Topic 718 “ Stock
Compensation. ” Under FASB ASC Topic 718, the Company recognizes the grant date fair value of stock-based employee compensation as expense on a straight-
line basis over the vesting period of the grant. The Company uses the Black Scholes option pricing model to determine the grant date fair value of employee stock
options. The fair value of restricted stock awards is equal to the closing price of the Company’s stock on the date such award was granted.
F-24
Income Taxes
The Company provides for income taxes using the asset and liability method as required by FASB ASC Topic 740, “ Income Taxes .” This approach
recognizes the amount of federal, state, local and foreign taxes payable or refundable for the current year, as well as deferred tax assets and liabilities for the future
tax consequences of events recognized in the consolidated financial statements and income tax returns. Deferred income tax assets and liabilities are adjusted to
recognize the effects of changes in tax laws or enacted tax rates in the period during which they are signed into law. FASB ASC Topic 740 requires an assessment
of whether valuation allowances are needed against deferred tax assets based upon consideration of all available evidence using a more likely than not
standard. See "Note 19. Income Taxes" for further discussion of the Company’s valuation allowances.
FASB ASC Topic 740, Sub-topic 10 “ Tax Positions ,” defines the criterion an individual tax position must meet for any part of the benefit of the tax
position to be recognized in financial statements prepared in conformity with generally accepted accounting principles. Under FASB ASC Topic 740, Sub-topic 10,
the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not the tax position will be sustained on examination by the
taxing authorities, based solely on the technical merits of the tax position. The tax benefits recognized in the financial statements from such a tax position should
be measured based on the largest benefit having a greater than 50% likelihood of being realized upon ultimate settlement with the tax authority. Additionally,
FASB ASC Topic 740, Sub-topic 10 provides guidance on measurement, de-recognition, classification, interest and penalties, accounting in interim periods,
disclosure, and transition. In accordance with the disclosure requirements of FASB ASC Topic 740, Sub-topic 10, the Company’s policy on income statement
classification of interest and penalties related to income tax obligations is to include such items as part of total interest expense and other expense, respectively.
Other Comprehensive Income
The Company follows the provisions of FASB ASC Topic 220, ” Comprehensive Income, ” which establishes standards for the reporting and display of
comprehensive income and its components. Comprehensive income is defined to include all changes in equity during a period except those resulting from
investments by owners and distributions to owners. The Company recorded foreign currency translation gains and losses, which are reported as comprehensive
income. Foreign currency translation gains (losses) for the years ended December 31, 2016 , 2015 and 2014 were $2.6 million , $(4.5) million and $(7.1) million ,
respectively.
5. RECENT ACCOUNTING PRONOUNCEMENTS
In May 2014, the FASB issued Accounting Standards Update ("ASU") 2014-09, “ Revenue from Contracts with Customers ” (Topic 606) regarding the
accounting for and disclosures of revenue recognition, with an effective date for annual and interim periods beginning after December 15, 2016. This update
provides a single comprehensive model for accounting for revenue from contracts with customers. The model requires that revenue recognized reflect the actual
consideration to which the entity expects to be entitled in exchange for the goods or services defined in the contract, including in situations with multiple
performance obligations. In July 2015, the FASB issued ASU 2015-14, “ Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date ,”
which deferred the effective date of the previously issued revenue recognition guidance by one year. The guidance will be effective for annual and interim periods
beginning after December 15, 2017. In April 2016 and May 2016, the FASB issued ASU 2016-10, " Revenue from Contracts with Customers (Topic 606):
Identifying Performance Obligations and Licensing " and ASU 2016-12, " Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and
Practical Expedients ," respectively. Both of these updates provide improvements and clarification to the previously issued revenue recognition guidance. The
guidance can be applied using one of two methods: retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of initially
applying the guidance recognized at the date of initial application. The Company is currently evaluating the effect that this guidance may have on its consolidated
financial statements.
In July 2015, the FASB issued ASU 2015-11, Inventory (Topic 330): “ Simplifying the Measurement of Inventory ,” with guidance regarding the
accounting for and measurement of inventory. The update requires that inventory measured using first-in, first-out ("FIFO") shall be measured at the lower of cost
and net realizable value. When there is evidence that the net realizable value of inventory is lower than its cost, the difference shall be recognized as a loss in
earnings in the period in which it occurs. The guidance will be effective for annual and interim periods beginning after December 15, 2016. The Company does not
expect the adoption of this guidance to have a material effect on its consolidated financial statements.
F-25
In September 2015, the FASB issued ASU 2015-16, Business Combinations (Topic 805): “ Simplifying the Accounting for Measurement-Period
Adjustments, ” with guidance regarding the accounting for and disclosure of measurement-period adjustments that occur in periods after a business combination is
consummated. This update requires that the acquirer recognize measurement-period adjustments in the reporting period in which they are determined and, as such,
eliminates the previous requirement to retrospectively account for these adjustments. This update also requires an entity to present separately on the face of the
income statement, or disclose in the notes, the amount recorded in the current-period income statement that would have been recorded in previous reporting periods
if the adjustments had been recognized as of the acquisition date. The effective date for annual and interim periods begins after December 15, 2015. The Company
adopted this guidance during 2016, and it did not have a material effect on the Company’s consolidated financial statements.
In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), with guidance regarding the accounting for and disclosure of leases. The update
requires lessees to recognize all leases, including operating leases, with a term greater than 12 months on the balance sheet. This update also requires lessees and
lessors to disclose key information about their leasing transactions. The guidance will be effective for annual and interim periods beginning after December 15,
2018. The Company is currently evaluating the effect that this guidance will have on its consolidated financial statements and related disclosures. The Company's
expects the implementation of this standard to have an impact on its consolidated financial statements and related disclosures as it has aggregate future minimum
lease payments of $30.2 million as of December 31, 2016 under the current portfolio of non-cancelable leases for land, office space, and manufacturing, warehouse
and research and development facilities with various expiration dates between April 2017 and October 2021. The Company anticipates recognition of additional
assets and corresponding liabilities related to these leases on its consolidated balance sheet.
In March 2016, the FASB issued ASU 2016-06, Derivatives and Hedging (Topic 915): " Contingent Put and Call Options in Debt Instruments ," with
guidance regarding the accounting for embedded derivatives related to debt contracts. The update clarifies that determining whether the economic characteristics of
a put or call are clearly and closely related to its debt host requires only an assessment of the four-step decision sequence outlined in FASB ASC paragraph 815-15-
25-24. The update also indicates that entities are not required to separately assess whether the contingency itself is clearly and closely related. The guidance will be
effective for annual and interim periods beginning after December 15, 2016. The Company does not expect the adoption of this guidance to have a material effect
on its consolidated financial statements.
In March 2016, the FASB issued ASU 2016-09, Compensation - Stock Compensation (Topic 718): " Improvements to Employee Share-Based Payment
Accounting ," with guidance regarding the simplification of accounting for share-based payment award transactions. The update changes the accounting for such
areas as the accounting and cash flow classification for excess tax benefits and deficiencies; forfeitures; and tax withholding requirements and cash flow
classification. The guidance will be effective for annual and interim periods beginning after December 15, 2016. The Company will adopt the new guidance
effective January 1, 2017 and has elected to eliminate the use of a forfeiture rate estimate in the determination of share-based compensation expense for restricted
stock awards using the modified retrospective transition method, which will result in an estimated $1.4 million charge to opening retained earnings. In addition, the
Company will present the cash paid for tax withholdings on stock options exercised and restricted stock awards vested in financing as opposed to the historical
presentation in operating cash flows. Excess tax benefits or deficiencies, historically recorded to additional paid-in capital, will upon adoption be recorded to
income tax expense as they occur.
In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): " Classification of Certain Cash Receipts and Cash Payments, "
with guidance intended to reduce the diversity in practice regarding how certain cash receipts and cash payments are presented and classified within the statement
of cash flows. The update addresses eight specific cash flow issues including debt prepayment or debt extinguishment costs, the settlement of zero-coupon debt
instruments or other debt instruments with coupon interest rates that are insignificant in relation to the effective interest rate of the borrowing, contingent
consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement of corporate-owned life
insurance policies (COLIs) (including bank-owned life insurance policies (BOLIs)), distributions received from equity method investees, beneficial interests in
securitization transactions, and separately identifiable cash flows and application of the predominance principle. The guidance will be effective for annual and
interim periods beginning after December 15, 2017. The Company is currently evaluating the effect that this guidance may have on its consolidated financial
statements.
In October 2016, the FASB issued ASU-2016-16, Income Taxes (Topic 740): " Intra-Entity Transfers of Assets Other Than Inventory, " with guidance
intended to more faithfully represent the economics of intra-entity asset transfers. The update clarifies that entities must recognize the income tax consequences of
intra-entity asset transfers, other than inventory, when the transfer occurs. The guidance will be effective for annual and interim periods beginning after December
15, 2017. The Company is currently evaluating the effect that this guidance may have on its consolidated financial statements.
F-26
In December 2016, the FASB issued ASU-2016-19, Technical Corrections and Improvements, with amendments that cover a wide range of topics in the
Accounting Standards Codification. This update includes amendments related to differences between original guidance and the Accounting Standards Codification,
guidance clarification and reference corrections, simplifications to the Accounting Standards Codification, and minor improvements to the guidance. Most of the
amendments do not require transition guidance and are effective upon issuance of the update. However, six amendments clarify guidance or correct references in
the Accounting Standards Codification that could potentially result in changes in current practice because of either misapplication or misunderstanding of current
guidance. Early adoption is permitted for the amendments that require transition guidance. The Company adopted this guidance during 2016, and it did not have a
material effect on the Company’s consolidated financial statements.
6. FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS
The carrying values of cash equivalents, accounts receivable, prepaid expenses and other current assets, and accounts payable in the Company’s
consolidated balance sheets approximated their fair values as of December 31, 2016 and 2015 due to their short-term nature.
Certain of the Company’s financial instruments are measured at fair value using a three-level hierarchy that prioritizes the inputs used to measure fair
value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value
are as follows:
• Level 1 - Inputs are quoted prices for identical instruments in active markets.
• Level 2 - Inputs are quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not
active; or model-derived valuations whose inputs are observable or whose significant value drivers are observable.
• Level 3 - Inputs are unobservable and reflect the Company's own assumptions, based on the best information available, including the Company's own
data.
F-27
The carrying amounts and fair values of the Company’s financial instruments as of December 31, 2016 and 2015 are indicated below (in thousands):
As of December 31, 2016
Fair Value Measurement Based on
Carrying
Amount
Fair Value
Quoted Prices in
Active Markets
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Assets
Deferred Compensation Plan assets (1)
$
37,382 $
37,382 $
— $
37,382 $
Liabilities
Term Loan Facility due August 2021, current portion (2)
$
Term Loan Facility due August 2021, long-term portion (2) $
2% Convertible Senior Notes due June 2022 (3)
Deferred Compensation Plan liabilities (1)
Contingent consideration (4)
$
$
$
20,000 $
20,000 $
375,000 $
375,000 $
— $
— $
600,000 $
469,800 $
469,800 $
28,582 $
31,048 $
28,582 $
31,048 $
— $
— $
20,000 $
375,000 $
— $
28,582 $
— $
—
—
—
—
—
31,048
As of December 31, 2015
Fair Value Measurement Based on
Carrying
Amount
Fair Value
Quoted Prices in
Active Markets
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Assets
Deferred Compensation Plan assets (1)
Liabilities
2% Convertible Senior Notes due June 2022 (3)
Deferred Compensation Plan liabilities (1)
$
$
$
30,726 $
30,726 $
— $
30,726 $
600,000 $
602,250 $
602,250 $
— $
25,581 $
25,581 $
— $
25,581 $
—
—
—
(1) The Deferred Compensation Plan liabilities are non-current liabilities recorded at the value of the amount owed to the plan participants, with changes in
value recognized as compensation expense in the Company’s consolidated statements of operations. The calculation of the Deferred Compensation Plan
obligation is derived from observable market data by reference to hypothetical investments selected by the participants and is included in the line item
captioned “Other non-current liabilities” on the Company’s consolidated balance sheets. The Company invests participant contributions in corporate-
owned life insurance (“COLI”) policies, for which the cash surrender value is included in the line item captioned “Other non-current assets” on the
Company’s consolidated balance sheets.
(2) The difference between the amount shown as the carrying value in the above tables and the amount shown on the Company’s consolidated balance sheets
as of December 31, 2016 and 2015 represents the unaccreted discount related to deferred debt issuance costs.
(3) The difference between the amount shown as the carrying value in the above tables and the amount shown on the Company’s consolidated balance sheets
at December 31, 2016 and 2015 represents the unaccreted discounts related to deferred debt issuance costs and bifurcation of the conversion feature of the
notes.
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(4) The contingent consideration liability is a non-current liability representing future consideration potentially payable to Teva upon the achievement of
specified commercialization events related to methylphenidate hydrochloride in accordance with the Termination Agreement related to the Teva
Transaction as described in "Note 2. Business Acquisitions." A discounted cash flow valuation model was used to value the contingent consideration. The
valuation is based on significant unobservable inputs, including the probability and timing of successful product launch and the expected number of
competitors at the time of launch and the launch anniversary date. The Company conducts a quarterly review of the underlying inputs and assumptions
and significant changes in unobservable inputs could result in material changes to the contingent consideration liability. Changes in the value of the
contingent consideration liability are included in "Other income (expense)" on the Company's consolidated statements of operations. A 5% increase or
decrease in the probability of successful product launch would cause the fair value of the contingent consideration to both increase and decrease by $1.6
million , respectively. An increase or decrease in the number of competitors at the date of the product launch or the first anniversary would cause the fair
value of the contingent consideration to decrease by $13.4 million and increase by $5.1 million , respectively. The maximum aggregate amount in
contingent consideration payments the Company could be expected to make to Teva in accordance with the Termination Agreement related to
methylphenidate hydrochloride is $40.0 million .
The following table presents the changes in Level 3 instruments measured on a recurring basis for the year ended December 31, 2016 (in thousands):
Contingent consideration
—
As of December 31,
2015
Completion of Teva
Transaction
August 3,
2016
$30,100
Change in
Fair Value Included
in Earnings (1)
$948
As of December 31,
2016
$31,048
(1) Earnings effect is included in Other, net in Other income (expense) in the Company's consolidated statement of operations.
7. SHORT-TERM INVESTMENTS
Prior to December 31, 2014, the Company invested its excess cash in high quality (AAA-rated) short-maturity marketable debt securities, such as
commercial paper and corporate bonds. The Company historically held all of its investments in marketable debt securities until maturity. Accordingly, these
investments were accounted for as “held-to-maturity” securities and were recorded at amortized cost, which approximated fair value. During the first quarter of
2015, the Company allowed all of its investments in marketable debt securities to mature. The proceeds from these maturities of $200.1 million were used to fund
part of the Tower Acquisition on March 9, 2015. The Company held no short-term investments as of December 31, 2016 and 2015 .
F-29
8. ACCOUNTS RECEIVABLE
The composition of accounts receivable, net is as follows (in thousands):
Gross accounts receivable (1)
Less: Rebate reserve
Less: Chargeback reserve
Less: Distribution services reserve
Less: Discount reserve
Less: Uncollectible accounts reserve (2)
Accounts receivable, net
December 31, 2016
December 31, 2015
$
$
780,865 $
(277,800)
(154,686)
(18,318)
(17,957)
(54,736)
257,368 $
738,730
(265,229)
(102,630)
(12,576)
(18,657)
(15,187)
324,451
(1) Includes estimated $40.3 million and $40.6 million as of December 31, 2016 and 2015 , respectively, receivable due from Turing for reimbursement
of Daraprim® chargebacks and Medicaid rebate liabilities.
(2) As a result of the uncertainty of collection that developed since the filing of the Company’s Annual Report on Form 10-K for the year ended
December 31, 2015, the Company recorded a reserve of $48.0 million as of March 31, 2016, which represented the full amount of the estimated
receivable due from Turing. See "Note 4. Summary of Significant Accounting Policies - Concentration of Credit Risk" for additional information
regarding the Turing receivable. During the fourth quarter of 2016, the Company received a $7.7 million payment from Turing, which reduced the reserve
balance to $40.3 million as of December 31, 2016 .
A roll-forward of the rebate and chargeback reserves activity for the years ended December 31, 2016 , 2015 and 2014 is as follows (in thousands):
Rebate reserve
Beginning balance
Acquired balances
Provision recorded during the period for Impax Generics rebates
Credits issued during the period for Impax Generics rebates
Ending balance
Years Ended December 31,
2016
2015
2014
$
$
265,229 $
88,812 $
—
740,758
(728,187)
75,447
571,642
(470,672)
277,800 $
265,229 $
88,449
—
260,747
(260,384)
88,812
The payment mechanisms for rebates in the Impax Generics and Impax Specialty Pharma divisions are different, which impacts the location on the
Company's consolidated balance sheets. Impax Specialty Pharma rebates are classified as "Accrued expenses" on the Company's consolidated balance sheets.
Chargeback reserve
Beginning balance
Acquired balances
Provision recorded during the period
Credits issued during the period
Ending balance
9. INVENTORY
Years Ended December 31,
2016
2015
2014
$
$
102,630 $
43,125 $
—
1,014,108
(962,052)
24,532
833,157
(798,184)
154,686 $
102,630 $
37,066
—
487,377
(481,318)
43,125
Inventory, net of carrying value reserves, as of December 31, 2016 and 2015 consisted of the following (in thousands):
Raw materials
Work in-process
Finished goods
Total inventory
Less: Non-current inventory
Total inventory-current
December 31, 2016
December 31, 2015
$
$
53,808 $
3,280
130,879
187,967
12,737
175,230 $
52,366
4,417
82,311
139,094
13,512
125,582
Inventory carrying value reserves were $38.0 million and $24.1 million as of December 31, 2016 and 2015 , respectively.
The Company recognizes pre-launch inventories at the lower of its cost or the expected net selling price. Cost is determined using a standard cost method,
which approximates actual cost, and assumes a FIFO flow of goods. Costs of unapproved products are the same as approved products and include materials, labor,
quality control, and production overhead. When the Company concludes FDA approval is expected within approximately six months, the Company will generally
begin to schedule manufacturing process validation studies as required by the FDA to demonstrate the production process can be scaled up to manufacture
commercial batches. Consistent with industry practice, the Company may build quantities of pre-launch inventories of certain products pending required final FDA
approval and/or resolution of patent infringement litigation, when, in the Company’s assessment, such action is appropriate to prepare for the anticipated
commercial launch, FDA approval is expected in the near term, and/or the related litigation will be resolved in the Company’s favor. The capitalization of
unapproved pre-launch inventory involves risks, including, among other items, FDA approval of product may not occur; approvals may require additional or
different testing and/or
F-30
specifications than used for unapproved inventory; and, in cases where the unapproved inventory is for a product subject to litigation, the litigation may not be
resolved or settled in favor of the Company. If any of these risks were to materialize and the launch of the unapproved product delayed or prevented, then the net
carrying value of unapproved inventory may be partially or fully reserved. Generally, the selling price of a generic pharmaceutical product is at discount from the
corresponding brand product selling price. Typically, a generic drug is easily substituted for the corresponding branded product, and once a generic product is
approved, the pre-launch inventory is typically sold within the subsequent three months . If the market prices become lower than the product inventory carrying
costs, then the pre-launch inventory value is reduced to such lower market value. If the inventory produced exceeds the estimated market acceptance of the generic
product and becomes short-dated, a carrying value reserve will be recorded. In all cases, the carrying value of the Company's pre-launch product inventory is lower
than the respective estimated net selling prices. The carrying value of unapproved inventory less reserves was $29.2 million and $8.7 million at December 31, 2016
and 2015 , respectively.
To the extent inventory is not scheduled to be utilized in the manufacturing process and/or sold within twelve months of the balance sheet date, it is
included as a component of other non-current assets. Amounts classified as non-current inventory consist of raw materials, net of valuation reserves. Raw materials
generally have a shelf life of approximately three to five years, while finished goods generally have a shelf life of approximately two years.
10. PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment, net of accumulated depreciation, consisted of the following (in thousands):
Land
Buildings and improvements
Equipment
Office furniture and equipment
Construction-in-progress
Property, plant and equipment, gross
Less: Accumulated depreciation
Property, plant and equipment, net
December 31, 2016
December 31, 2015
$
$
5,603 $
174,303
143,818
15,767
50,191
389,682
(156,310)
233,372 $
5,773
165,322
135,998
14,548
25,659
347,300
(133,144)
214,156
Depreciation expense was $29.1 million , $25.5 million and $20.4 million for the years ended December 31, 2016 , 2015 and 2014 , respectively.
Unpaid vendor invoices relating to purchases of property, plant and equipment of $4.0 million , $4.5 million and $1.9 million , which were accrued as of
December 31, 2016 , 2015 and 2014 , respectively, have been excluded from the purchase of property, plant, and equipment and the change in accounts payable
and accrued expenses in the Company’s consolidated statements of cash flows.
11. INTANGIBLE ASSETS AND GOODWILL
Intangible Assets
The Company's intangible assets include both finite lived and indefinite-lived assets. Finite lived intangible assets, consisting of marketed product rights
and royalties received from product sales by the Company's third party partners, are amortized over the estimated useful life of the asset based on the pattern in
which the economic benefits are expected to be consumed or otherwise used up or, if that pattern is not readily determinable, on a straight-line basis. The
remaining weighted-average amortization period for the Company's finite lived intangible assets not yet fully amortized is 8.2 years as of December 31, 2016 .
Indefinite-lived intangible assets consist of acquired IPR&D product rights and acquired future royalty rights to be paid based on other companies’ net sales of
products not yet approved. IPR&D assets acquired in a business combination are considered indefinite-lived until the completion or abandonment of the associated
research and development efforts. Amortization over the estimated useful life will commence at the time of the respective product’s launch. If FDA approval to
market the product is not obtained, the Company will immediately expense the related capitalized cost.
F-31
Finite lived intangible assets are tested for impairment when events or changes in circumstances indicate that the carrying value of the asset may not be
recoverable. All of the Company's indefinite-lived intangible assets are tested for impairment at least annually during the fourth quarter of the fiscal year, or more
often if indicators of impairment are present. Impairment testing requires management to estimate the future undiscounted cash flows of an intangible asset using
assumptions believed to be reasonable, but which are unpredictable and inherently uncertain. Actual future cash flows may differ from the estimates used in the
impairment testing. The Company recognizes an impairment loss when and to the extent that the estimated fair value of an intangible asset is less than its carrying
value.
The following tables show the gross carrying values and accumulated amortization, where applicable, of the Company’s intangible assets by type for the
consolidated balance sheets presented (in thousands):
December 31, 2016
Amortized intangible assets:
Marketed product rights
Royalties
Non-amortized intangible assets:
Acquired IPR&D product rights
Acquired future royalty rights
Total intangible assets
December 31, 2015
Amortized intangible assets:
Marketed product rights
Royalties
Non-amortized intangible assets:
Acquired IPR&D product rights
Acquired future royalty rights
Total intangible assets
Gross Carrying Value
Accumulated Amortization
Intangible Assets, Net
524,733 $
339
525,072
232,576
2,402
234,978
760,050 $
(139,245) $
(339)
(139,584)
—
—
—
(139,584) $
385,488
—
385,488
232,576
2,402
234,978
620,466
Gross Carrying Value
Accumulated Amortization
Intangible Assets, Net
458,675 $
2,200
460,875
145,640
78,600
224,240
685,115 $
(82,906) $
(189)
(83,095)
—
—
—
(83,095) $
375,769
2,011
377,780
145,640
78,600
224,240
602,020
$
$
$
$
During the first quarter of 2016, the Company capitalized $3.5 million of milestone payments due to an affiliate of Teva under the terms of the product
agreement between the parties and related to the FDA's approval and the Company's subsequent commercial launch of Emverm® (mebendazole) 100 mg chewable
tablets. See "Note 20. Alliance and Collaboration Agreements" for additional information related to the Mebendazole Product Agreement. As of December 31,
2015, the Emverm® acquired IPR&D product right had a carrying value of $82.8 million , which was the fair value assigned by the Company during the purchase
price allocation accounting for the Tower Acquisition. As a result of the Company's commercial launch of the product during the first quarter of 2016, the
Company transferred the total $86.3 million of asset value from non-amortized, indefinite-lived acquired IPR&D product rights to amortized, finite-lived marketed
product rights and began amortization of the asset. The Emverm® marketed product right intangible asset will be amortized over an estimated useful life of nine
years based on the pattern of economic benefit expected to be realized through 2024.
During the second quarter of 2016, the Company recognized a total of $1.5 million of charges within cost of revenues impairment charges on the
Company's consolidated statement of operations related to two currently marketed products, which were acquired as part of the Tower Acquisition, primarily due
to active pharmaceutical ingredient ("API") supply issues and minimal sales activity, resulting in immediate discontinuation of one product and rapid phase-out of
the other. Additionally, one of the Company's IPR&D generic products, also acquired as part of the Tower Acquisition, was determined to be impaired as a
F-32
result of the commercial launch of a competitor's generic product, resulting in a $1.0 million charge to in-process research and development impairment charges on
the Company's consolidated statement of operations.
During the third quarter of 2016, the Company recorded $613.0 million of intangible asset additions as a result of the Teva Transaction, of which $455.5
million were amortized, finite-lived marketed product rights and $157.5 million were non-amortized, indefinite-lived acquired IPR&D product rights. Refer to
"Note 2. Business Acquisitions" for additional information on the Teva Transaction. Pursuant to the Termination Agreement, the Company reacquired its full
commercial rights to its pending ANDA for the generic equivalent to Concerta® (methylphenidate hydrochloride), a product candidate the Company had acquired
in the Tower Acquisition that the Company had previously partnered with Teva USA, in accordance with the terms of the Strategic Alliance Agreement, as
amended, pursuant to which each party would retain 50% of the gross profit realized upon sales of the product following approval. The Company's 50% interest in
this product was previously considered a non-amortized, indefinite-lived acquired future royalty right owing to the fact that Teva would sell the product upon
receiving FDA approval and pay the Company 50% of the gross profit realized. Upon reacquisition of Teva's interest in this product, the $70.8 million asset value
of the Company's 50% interest, determined at the time of the Tower Acquisition, was transferred to non-amortized, indefinite-lived acquired IPR&D products
rights, as reflected in the tables above.
In addition to the intangible asset additions resulting from the Teva Transaction as described above, during the third quarter of 2016, the Company also
commercially launched two products, resulting in the transfer of $11.0 million of asset value from non-amortized, indefinite-lived acquired IPR&D product rights
to amortized, finite-lived marketed products rights.
Upon closing the Teva Transaction on August 3, 2016, the Company initiated the process of transferring and securing Teva’s and Allergan’s customers
for the acquired products to its account. The Company assumed certain price concessions would occur following the closing, however, the Company elected to take
additional price reductions on certain of the acquired products in order to retain key customers. These reductions produced significantly lower than expected
operating cash flows from the Acquired Product Lines and triggered an impairment analysis. The Company's impairment analysis for the third quarter of 2016
resulted in the recognition of a total $251.0 million non-cash impairment charge to earnings. Of the total $251.0 million impairment charge, $248.0 million was
recorded in cost of revenues impairment charges and $3.0 million was recorded in in-process research and development impairment charges, each in the
Company’s consolidated statement of operations for the third quarter of 2016.
Certain other non-cash impairment charges unrelated to the Teva Transaction were also recorded in the third quarter of 2016. During the third quarter of
2016, the Company also recognized a total of $34.2 million of intangible asset impairment charges, of which $8.5 million was recognized in cost of revenues
impairment charges on the Company's consolidated statement of operations and attributable to the full impairment of three marketed products and one third-party
partnered product where the Company received royalties from the sale of such product. The affected products were manufactured in the Company's Middlesex,
New Jersey facility, which the Company is in the process of closing as discussed in "Note 18. Restructurings." The products were discontinued for several reasons,
including the inability to efficiently transfer technology to another manufacturing site, the inability to continue to secure API from third parties on a timely basis,
and/or minimal current and projected sales activity. The remaining $25.7 million of impairment charges recognized by the Company during the third quarter of
2016 were recognized in in-process research and development impairment charges and related to two of the Company's IPR&D product rights acquired in the
Tower Acquisition due to delays in expected start of commercialization and lower pricing amid highly competitive market conditions, resulting in lower expected
future cash flows.
During the fourth quarter of 2016, the Company recognized a total of $253.9 million of intangible asset impairment charges, of which $230.6 million was
recognized in cost of revenues impairment charges and $23.3 million was recognized in in-process research and development impairment charges on the
Company's consolidated statement of operations. More than half of the total impairment charges incurred during the fourth quarter of 2016 was attributable to the
Company’s epinephrine auto-injector product, which was acquired as part of the Tower Acquisition. The impairment charge on the epinephrine auto-injector
product was triggered by current and projected price degradation as a result of changes in the pricing environment and additional competition. The Company also
experienced even further price reductions on certain of the products acquired as part of the Teva Transaction during the fourth quarter of 2016, resulting in $57.4
million of additional intangible asset impairment charges, of which $53.7 million was recorded to cost of revenues impairment charges and $3.7 million was
recorded to in-process research and development impairment charges. In addition, the Company recognized $36.3 million of intangible asset impairment related to
its anthelmintic product franchise, of which $24.3 million was recorded to cost of revenues impairment charges and $12.0 million was recorded to in-process
research and development impairment charges. The $24.3 million charge was attributable to lower than expected script volume for Emverm®. The $12.0 million
charge recorded to in-process research and development during the fourth quarter of 2016 was attributable to a decision by the Company's management during the
fourth quarter of 2016 to cease development on a next-generation version of Albenza® as a result of continued difficulties sourcing the API. The remainder of the
fourth quarter of 2016 impairment charges were primarily attributable to the products acquired as part of the Tower Acquisition and resulted from lower current
and/or forecasted pricing amid highly competitive market conditions, resulting in lower forecasted future cash flows.
F-33
As a result of the annual intangible asset impairment testing performed during the fourth quarter of 2015, the Company recorded an impairment charge of
$13.7 million , of which $7.3 million was recorded in cost of revenues impairment charges and $6.4 million was recorded in in-process research and development
impairment charges in the Company's consolidated statement of operations. For the year ended December 31, 2015, the $13.7 million impairment charge was
generally attributable to deteriorating market conditions for a small number of marketed products or, for acquired IPR&D product rights, a delay to the anticipated
product launch or an economic decision by management not to move forward with the development or marketing of a product. The Company recorded an
impairment charge of $2.9 million to cost of revenues impairment charges in 2014 as a result of continued severe price erosion on one of its marketed products,
which price erosion began in 2013 and previously resulted in an impairment of the asset.
The Company recognized amortization expense of $56.4 million , $40.2 million and $11.1 million for the years ended December 31, 2016 , 2015 and
2014 , respectively, in cost of revenues in the consolidated statements of operations presented. The following table shows the expected future amortization of the
Company’s finite lived intangible assets as of December 31, 2016 (in thousands):
For the years ending December 31,
Amortization
Expense
2017
2018
2019
2020
2021
Thereafter
Total
$
$
66,651
69,718
61,808
48,555
34,880
103,876
385,488
Goodwill
Goodwill on the Company’s consolidated balance sheets at December 31, 2016 and 2015 was the result of the 2015 Tower Acquisition and the 1999
merger of Impax Pharmaceuticals, Inc. with Global Pharmaceuticals Corporation. Goodwill had a carrying value of $207.3 million and $210.2 million at
December 31, 2016 and 2015 , respectively. The change in the carrying value during the year ended December 31, 2016 compared to December 31, 2015 was
attributable to the finalization of the purchase price allocation during the first quarter of 2016 for the Tower Acquisition as a result of the completion and filing of
federal and state tax returns for the various entities acquired. This resulted in a first quarter adjustment of $1.8 million and a fourth quarter adjustment of $1.1
million to goodwill during the year ended December 31, 2016. At December 31, 2016 , the Company attributed $147.6 million and $59.7 million to the Impax
Generics division and the Impax Specialty Pharma division, respectively. The Company concluded based on the results of the annual testing performed that the
carrying value of goodwill was no t impaired as of December 31, 2016 or 2015 .
F-34
12. ACCRUED EXPENSES
The following table sets forth the Company’s accrued expenses (in thousands):
Payroll-related expenses
Product returns
Accrued shelf stock
Government rebates (1)
Legal and professional fees
Income taxes payable
Physician detailing sales force fees
Interest payable
Estimated Teva and Allergan chargebacks and rebates (2)
Other
Total accrued expenses
December 31, 2016 December 31, 2015
$
37,986 $
72,888
7,032
72,063
8,395
—
—
544
14,813
17,290
$
231,011 $
37,419
48,950
6,619
91,717
5,929
830
1,132
500
—
11,615
204,711
(1) Includes estimated $6.8 million and $40.6 million as of December 31, 2016 and 2015 , respectively, of liabilities for Daraprim® chargebacks and
rebates resulting from utilization by Medicaid, Medicare and other federal, state and local governmental programs, health plans and other health care
providers for product sold under the Company’s labeler code, which amounts are subject to reimbursement by Turing in accordance with the terms of
the Company's purchase agreement with Turing. The Company made payments of $33.5 million on Turing's behalf during 2016. See "Note 4.
Summary of Significant Accounting Policies - Concentration of Credit Risk" for additional information related to the Turing receivable.
(2) As discussed in "Note 2. Business Acquisitions," pursuant to certain agreed upon transition related services by and among the Company, Teva and
Allergan after the closing of the Teva Transaction, the Company agreed to manage the payment process for certain commercial chargebacks and
rebates on behalf of Teva and Allergan related to products each of Teva and Allergan sold into the channel prior to the Company's acquisition of the
products. On August 18, 2016, the Company received a payment totaling $42.4 million from Teva and Allergan, which represented their combined
estimate of the amount of commercial chargebacks and rebates to be paid by the Company on their behalf to wholesalers who purchased products from
Teva and Allergan prior to the closing. Pursuant to the agreed upon transition services, Teva and Allergan are obligated to reimburse the Company for
additional payments related to chargebacks and rebates for products they sold into the channel prior to the closing and made on their behalf in excess
of the $42.4 million . If the total payments made by the Company on behalf of Teva and Allergan are less than $42.4 million , the Company is
obligated to refund the difference to Teva and/or Allergan. As of December 31, 2016 , the Company had paid $27.6 million related to chargebacks and
rebates as described above and $14.8 million remained in accrued expenses on the Company's consolidated balance sheet.
Product Returns
The Company maintains a return policy to allow customers to return product within specified guidelines. The Company estimates a provision for product
returns as a percentage of gross sales based upon historical experience for sales made through its Impax Generics and Impax Specialty Pharma sales channels.
Sales of product under the Private Label, Rx Partner and OTC Partner alliance, collaboration and supply agreements are not subject to returns.
F-35
A rollforward of the return reserve activity for the years ended December 31, 2016 , 2015 and 2014 is as follows (in thousands):
Returns reserve
Beginning balance
Acquired balances
Provision related to sales recorded in the period
Credits issued during the period
Ending balance
13. DEBT
Royal Bank of Canada Credit Facilities
Years Ended December 31,
2016
2015
2014
$
$
48,950 $
27,174 $
—
52,383
(28,445)
11,364
43,967
(33,555)
72,888 $
48,950 $
28,089
—
12,016
(12,931)
27,174
On August 3, 2016, the Company entered into a restatement agreement with Royal Bank of Canada, as administrative agent, and the lenders and
guarantors party thereto (the "Restatement Agreement"). The Restatement Agreement amends and restates the Company's existing Revolving Credit Facility
Agreement (as amended and restated, the "Amended and Restated Credit Agreement") to, among other things, (i) add a term loan feature to allow for the
borrowing of up to $400.0 million of term loans (the "Term Loan Facility") by the Company in accordance with the terms of the Amended and Restated Credit
Agreement, (ii) increase the aggregate principal amount of revolving loans permitted under the Amended and Restated Credit Agreement (the "Revolving Credit
Facility," and, together with the Term Loan Facility, the "RBC Credit Facilities"), from $100.0 million to $200.0 million ; and (iii) extend the maturity date of the
Revolving Credit Facility from August 4, 2020 to August 3, 2021.
Borrowings under the Amended and Restated Credit Agreement will accrue interest at a rate equal to LIBOR or the base rate, plus an applicable margin.
The applicable margin may be increased or reduced by 0.25% based on the Company's total net leverage ratio. Up to $12.5 million of the Revolving Credit Facility
is available for issuance of letters of credit and any such letters of credit will reduce the amount available under the Revolving Credit Facility on a dollar-for-dollar
basis. The Company is required to pay a commitment fee to the lenders on the average daily unused portion of the Revolving Credit Facility at 0.50% or 0.375%
per annum, depending on the Company's total net leverage ratio.
The Amended and Restated Credit Agreement contains certain negative covenants (subject to exceptions, materiality thresholds and other allowances)
including, without limitation, negative covenants that limit the Company's and its restricted subsidiaries' ability to incur additional debt, guarantee other
obligations, grant liens on assets, make loans, acquisitions or other investments, dispose of assets, make optional payments in connection with or modify certain
debt instruments, pay dividends or make other payments on capital stock, engage in mergers or consolidations, enter into arrangements that restrict the Company's
and its restricted subsidiaries' ability to pay dividends or grant liens, engage in transactions with affiliates, or change its fiscal year. The Amended and Restated
Credit Agreement also includes a financial maintenance covenant whereby the Company must not permit its total net leverage ratio in any 12 -month period to
exceed 5.00 :1.00, as tested at the end of each fiscal quarter. The Company was in compliance with all of its covenants under the Amended and Restated Credit
Agreement as of December 31, 2016.
The Amended and Restated Credit Agreement contains events of default, including, without limitation (subject to customary grace periods and materiality
thresholds), events of default upon (i) the failure to make payments pursuant to the terms of the Amended and Restated Credit Agreement, (ii) violation of
covenants, (iii) incorrectness of representations and warranties, (iv) cross-default and cross-acceleration to other material indebtedness, (v) bankruptcy events, (vi)
material monetary judgments (to the extent not covered by insurance), (vii) certain matters arising under the Employee Retirement Income Security Act of 1974, as
amended, that could reasonably be expected to result in a material adverse effect, (viii) the actual or asserted invalidity of the documents governing the RBC Credit
Facilities, any material guarantees or the security interests (including priority thereof) required under the Amended and Restated Credit Agreement and (ix) the
occurrence of a change of control (as defined therein). Upon the occurrence of certain events of default, the obligations under the Amended and Restated Credit
Agreement may be accelerated and any remaining commitments thereunder may be terminated.
F-36
The full amount of proceeds from the Term Loan Facility of $400.0 million , along with $196.4 million of cash were used to finance the Teva Transaction
(including transaction costs) at closing on August 3, 2016. As of December 31, 2016, the full amount of the $200.0 million Revolving Credit Facility remains
available to the Company for working capital and other general corporate purposes.
In connection with the Term Loan Facility, the Company incurred $11.0 million of debt issuance costs for banking, legal and accounting fees and other
expenses which were recorded on the Company's consolidated balance sheet as a reduction to the current and long-term portions of debt related to the Term Loan
Facility. These deferred debt issuance costs will be accreted to interest expense over the term of the debt using the effective interest method. In connection with the
increase in the aggregate principal amount of revolving loans permitted under the Revolving Credit Facility, the Company incurred $0.8 million of debt issuance
costs for banking fees which were recorded as an asset with current and long-term portions on the Company's consolidated balance sheet. These deferred debt
issuance costs, in addition to the $0.3 million balance remaining from the initial $100.0 million revolving credit facility, will be amortized to interest expense over
the term of the Revolving Credit Facility using the straight-line method.
For the period of August 3, 2016 through December 31, 2016 , the Company recognized $6.9 million of interest expense related to the Term Loan
Facility, of which $6.0 million was cash and $0.9 million was non-cash accretion of the debt discount recorded for deferred debt issuance costs. As of
December 31, 2016 , the Term Loan Facility had a carrying value of $384.9 million , of which $17.7 million is classified as current debt and $367.2 million is
classified as long-term debt on the Company's consolidated balance sheets. The Term Loan Facility requires quarterly principal payments of $5.0 million beginning
from December 2016 through June 2021, and the remaining principal balance is payable in August 2021. As of December 31, 2016, the outstanding principal
amount for the Term Loan Facility was $395.0 million .
2% Convertible Senior Notes due June 2022
On June 30, 2015, the Company issued an aggregate principal amount of $600.0 million of 2.00% Convertible Senior Notes due June 2022 (the “Notes”)
in a private placement offering, which are the Company’s senior unsecured obligations. The Notes were issued pursuant to an Indenture dated June 30, 2015 (the
“Indenture”) between the Company and Wilmington Trust, N.A., as trustee. The Indenture includes customary covenants and sets forth certain events of default
after which the Notes may be due and payable immediately. The Notes will mature on June 15, 2022, unless earlier redeemed, repurchased or converted. The Notes
bear interest at a rate of 2.00% per year, and interest is payable semiannually in arrears on June 15 and December 15 of each year, beginning on December 15,
2015.
The conversion rate for the Notes is initially set at 15.7858 shares per $1,000 of principal amount, which is equivalent to an initial conversion price of
$63.35 per share of the Company’s common stock. If a Make-Whole Fundamental Change (as defined in the Indenture) occurs or becomes effective prior to the
maturity date and a holder elects to convert its Notes in connection with the Make-Whole Fundamental Change, the Company is obligated to increase the
conversion rate for the Notes so surrendered by a number of additional shares of the Company’s common stock as prescribed in the Indenture. Additionally, the
conversion rate is subject to adjustment in the event of an equity restructuring transaction such as a stock dividend, stock split, spinoff, rights offering, or
recapitalization through a large, nonrecurring cash dividend (“standard antidilution provisions,” per FASB ASC 815-40, Contracts in Entity’s Own Equity ("ASC
815-40")).
The Notes are convertible at the option of the holders at any time prior to the close of business on the business day immediately preceding December 15,
2021 only under the following circumstances:
(i)
If during any calendar quarter commencing after the quarter ending September 30, 2015 (and only during such calendar quarter) the last reported sale
price of the Company’s common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending
on the last trading day of the immediately preceding calendar quarter is greater than 130% of the conversion price on each applicable trading day; or
(ii) If during the five business day period after any 10 consecutive trading day period (the “measurement period”) in which the trading price per $1,000 of
principal amount of Notes for each trading day of the measurement period was less than 98% of the product of the last report sale price of the
Company’s common stock and the conversion rate on each such trading day; or
(iii) Upon the occurrence of corporate events specified in the Indenture.
F-37
On or after December 15, 2021 until the close of business on the second scheduled trading day immediately preceding the maturity date, the holders may
convert their Notes at any time, regardless of the foregoing circumstances. The Company may satisfy its conversion obligation by paying or delivering, as the case
may be, cash, shares of the Company’s common stock, or a combination of cash and shares of the Company’s common stock, at the Company’s election and in the
manner and subject to the terms and conditions provided in the Indenture.
Concurrently with the offering of the Notes and using a portion of the proceeds from the sale of the Notes, the Company entered into a series of
convertible note hedge and warrant transactions (the “Note Hedge Transactions” and “Warrant Transactions”) which are designed to reduce the potential dilution
to the Company’s stockholders and/or offset the cash payments the Company is required to make in excess of the principal amount upon conversion of the Notes.
The Note Hedge Transactions and Warrant Transactions are separate transactions, in each case, entered into by the Company with a financial institution and are not
part of the terms of the Notes. These transactions will not affect any holder’s rights under the Notes, and the holders of the Notes have no rights with respect to the
Note Hedge Transactions and Warrant Transactions. See “Note 14. Stockholders’ Equity” for additional information.
At the June 30, 2015 issuance date of the Notes, the Company did not have the necessary number of authorized but unissued shares of its common
available to share-settle the conversion option of the Notes. Therefore, in accordance with guidance found in FASB ASC 470-20, Debt with Conversion and Other
Options, and FASB Topic ASC 815-15, Embedded Derivatives , the conversion option of the Notes was deemed an embedded derivative requiring bifurcation from
the Notes (host contract) and separate accounting as a derivative liability. The fair value of the conversion option derivative liability at June 30, 2015 was $167.0
million , which was recorded as a reduction to the carrying value of the debt and will be accreted to interest expense over the term of the debt using the effective
interest method. Although the Company subsequently amended the Company's Restated Certificate of Incorporation to increase the authorized number of shares of
the Company's common stock in December 2015, the debt discount remains and continues to be accreted to interest expense. See "Note 14. Stockholders' Equity"
for additional information.
In connection with the issuance of the Notes, the Company incurred $18.7 million of debt issuance costs for banking, legal and accounting fees and other
expenses. This amount was also recorded on the Company’s balance sheet as a reduction to the carrying value of the debt and is being accreted to interest expense
over the term of the debt using the effective interest method.
For the years ended December 31, 2016 and 2015 , the Company recognized $33.8 million and $16.3 million , respectively, of interest expense related to
the Notes, of which $12.0 million and $6.0 million , respectively, was cash and $21.8 million and $10.3 million , respectively, was non-cash accretion of the debt
discounts recorded. As the Notes mature in 2022, they have been classified as long-term debt on the Company’s consolidated balance sheets, with a carrying value
of $446.4 million and $424.6 million as of December 31, 2016 and 2015 , respectively. Accrued interest payable on the Notes of $0.5 million as of both
December 31, 2016 and 2015 was included in accrued expenses on the Company's consolidated balance sheets.
Loss on Early Extinguishment of Debt – Barclays $435.0 million Term Loan
In connection with the Tower Acquisition during the first quarter of 2015, the Company entered into a $435.0 million senior secured term loan facility
(the “Barclays Term Loan”) and a $50.0 million senior secured revolving credit facility (the “Barclays Revolver” and collectively with the Barclays Term Loan,
the “Barclays Senior Secured Credit Facilities”), pursuant to a credit agreement, dated as of March 9, 2015, by and among the Company, the lenders party thereto
from time to time and Barclays Bank PLC ("Barclays"), as administrative and collateral agent (the “Barclays Credit Agreement”). In connection with the Barclays
Senior Secured Credit Facilities, the Company incurred debt issuance costs for banking, legal and accounting fees and other expenses of $17.8 million , which were
previously reflected as a discount to the carrying value of the debt on the Company's consolidated balance sheet in accordance with ASU 2015-03. Prior to
repayment of the Barclays Term Loan on June 30, 2015, this debt discount was accreted to interest expense over the term of the loan using the effective interest
rate method.
On June 30, 2015, the Company used $436.4 million of the proceeds from the sale of the Notes to repay the $435.0 million of principal and $1.4 million
of accrued interest due on its Barclays Term Loan under the Barclays Credit Agreement. In connection with this repayment of the loan, for the quarter ended June
30, 2015, the Company recorded a loss on early extinguishment of debt of $16.9 million related to the unaccreted portion of the debt discount.
For the six months ended June 30, 2015, the Company incurred total interest expense related to the Barclays Term Loan of $10.7 million , of which $9.8
million was cash and $0.9 million was non-cash accretion of the debt discount recorded. In addition, included in interest expense for 2015 is a $2.3 million ticking
fee paid to Barclays during the first quarter of 2015, prior to the funding of the Barclays Senior Secured Credit Facilities on March 9, 2015, to lock in the financing
terms from the lenders’ commitment of the Barclays Term Loan until the actual allocation of the loan occurred at the closing of the Tower Acquisition.
F-38
14. STOCKHOLDERS’ EQUITY
Preferred Stock
Pursuant to its Restated Certificate of Incorporation (the “Certificate of Incorporation”), the Company is authorized to issue 2,000,000 shares of “blank
check” preferred stock, $0.01 par value per share, which enables the Board of Directors, from time to time, to create one or more new series of preferred stock.
Each series of preferred stock issued can have the rights, preferences, privileges and restrictions designated by the Board of Directors. The issuance of any new
series of preferred stock could affect, among other things, the dividend, voting, and liquidation rights of the Company’s common stock. The Company had no
preferred stock issued or outstanding as of December 31, 2016 and 2015 .
Common Stock
Pursuant to its Certificate of Incorporation, the Company is authorized to issue 150,000,000 shares of common stock, $0.01 par value per share, of which
73,948,340 shares have been issued and 73,704,611 shares were outstanding as of December 31, 2016 . In addition, the Company had reserved for issuance the
following amounts of shares of its common stock for the purposes described below as of December 31, 2016 (in thousands):
Shares issued
Stock options outstanding (1)
Conversion of Notes payable (2)
Warrants outstanding (see below)
Total shares of common stock issued and reserved for issuance
(1) See “Note 16. Share-Based Compensation”
(2) See “Note 13. Debt”
Warrants
73,948
2,234
9,471
9,471
95,124
As discussed in “Note 13. Debt”, on June 30, 2015, the Company entered into a series of Note Hedge Transactions and Warrant Transactions with a
financial institution which are designed to reduce the potential dilution to the Company’s stockholders and/or offset the cash payments the Company is required to
make in excess of the principal amount upon conversion of the Notes. Pursuant to the Warrant Transactions, the Company sold to a financial institution 9.47
million warrants to purchase the Company’s common stock, for which it received proceeds of $88.3 million . The warrants have an exercise price of $81.277 per
share (subject to adjustment), are immediately exercisable, and have an expiration date of September 15, 2022.
Additional Paid-In Capital
Pursuant to the Note Hedge Transactions, the Company purchased from a financial institution 0.6 million call options on the Company's common stock,
for which it paid consideration of $147.0 million . Each call option entitles the Company to purchase 15.7858 shares of the Company's common stock at an
exercise price of $63.35 per share, is immediately exercisable, and has an expiration date of June 15, 2022, subject to earlier exercise. At the time of the Note
Hedge Transactions, because of an insufficient number of authorized but unissued shares of the Company's common stock, these call options did not meet the
criteria for equity classification under ASC 815-40 and were accounted for as a derivative asset.
As of December 8, 2015, pursuant to the Company's amendment to its Certificate of Incorporation to increase the number of authorized shares of
common stock, the call options purchased pursuant to the Note Hedge Transactions (formerly a derivative asset) and the conversion option of the Notes (formerly
an embedded derivative liability) were reclassified to equity in additional paid-in capital. The net effect of the reclassification of these derivatives was a $21.0
million , net of tax, increase in additional paid-in capital reflected on the Company's December 31, 2015 consolidated balance sheet.
During the year ended December 31, 2015, the Company recognized in its consolidated statement of operations $13.0 million of net expense related to the
change in the fair value of the former derivative asset and liability. There was no comparable expense recognized in 2016.
F-39
15. EARNINGS PER SHARE
The Company's basic earnings per common share (“EPS”) is computed by dividing net income (loss) available to the Company’s common stockholders
(as presented on the consolidated statements of operations) by the weighted-average number of shares of the Company’s common stock outstanding during the
period. The Company’s restricted stock awards (non-vested shares) are issued and outstanding at the time of grant but are excluded from the Company’s
computation of weighted-average shares outstanding in the determination of basic EPS until vesting occurs.
For purposes of calculating diluted EPS, the denominator includes both the weighted-average number of shares of common stock outstanding and the
number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include
warrants, stock options and non-vested restricted stock awards using the treasury stock method and the number of shares of common stock issuable upon
conversion of the Company’s outstanding convertible notes payable. In the case of the Company’s outstanding convertible notes payable, the diluted EPS
calculation is further affected by an add-back of interest expense, net of tax, to the numerator under the assumption that the interest would not have been incurred if
the convertible notes had been converted into common stock.
The following is a reconciliation of basic and diluted net income (loss) per share of common stock for the three years ended December 31, 2016 , 2015
and 2014 (in thousands, except per share amounts):
Basic (Loss) Earnings Per Common Share:
Net (loss) income
Weighted-average common shares outstanding
Basic (loss) earnings per share
Diluted (Loss) Earnings Per Common Share:
Net (loss) income
Add-back of interest expense on outstanding convertible notes
payable, net of tax
Adjusted net (loss) income
$
$
$
$
Years Ended December 31,
2016
2015
2014
(472,031)
$
38,997
$
71,147
69,640
(6.63)
$
0.56
$
57,353
68,186
0.84
(472,031)
$
38,997
$
57,353
— (1)
— (2)
— (3)
(472,031)
$
38,997
$
57,353
Weighted-average common shares outstanding
71,147
69,640
68,186
Weighted-average incremental shares related to assumed exercise of
warrants and stock options, vesting of non-vested shares and ESPP
share issuance
Weighted-average incremental shares assuming conversion of
outstanding notes payable
Diluted weighted-average common shares outstanding
— (4)
2,387 (5)
2,344
— (1)
— (2)
71,147 (4)
72,027 (6)
— (3)
70,530 (7)
Diluted net (loss) income per share
$
(6.63)
$
0.54
$
0.81
(1) For the year ended December 31, 2016 , the Company incurred a net loss, which cannot be diluted, so basic and diluted loss per common share were the same.
Accordingly, there were no numerator or denominator adjustments related to the Company's outstanding Notes.
(2) The numerator and denominator adjustments related to the Company’s convertible notes payable were excluded from the computation because the add-back of
interest expense, net of tax, to the numerator had a greater effect on the quotient than the inclusion of the incremental shares assuming conversion of the
convertible notes payable in the denominator, resulting in anti-dilution.
(3) Not applicable to the period presented.
F-40
(4) For the year ended December 31, 2016 , the Company incurred a net loss, which cannot be diluted, so basic and diluted loss per common share were the same.
As of December 31, 2016 , shares issuable but not included in the Company's calculation of diluted EPS, which could potentially dilute future earnings,
included 9.47 million warrants outstanding, 9.47 million shares for conversion of outstanding Notes payable, 2.2 million stock options outstanding and 2.2
million non-vested restricted stock awards.
(5) As of December 31, 2015 , the approximately 9.47 million warrants outstanding have been excluded from the denominator of the diluted EPS computation
under the treasury stock method because the exercise price of the warrants exceeds the average market price of the Company’s common stock for the period,
so inclusion in the calculation would be anti-dilutive.
(6) As of December 31, 2015 , shares issuable but not included in the Company’s calculation of diluted EPS, which could potentially dilute future earnings,
included 9.47 million for warrants outstanding, 9.47 million shares for conversion of outstanding Notes payable, 1.7 million stock options outstanding and 1.5
million non-vested restricted stock awards.
(7) For the year ended December 31, 2014 , the Company excluded 0.9 million stock options from the computation of diluted net income per common share as the
effect of these options would have been anti-dilutive.
16. SHARE-BASED COMPENSATION
The Company recognizes the grant date fair value of each option and share of restricted stock over its vesting period. Stock options and restricted stock
awards are granted under the Company’s Third Amended and Restated 2002 Equity Incentive Plan (the “2002 Plan”), generally vest over a four year period and, in
the case of stock options, have a term of ten years.
Impax Laboratories, Inc. 1999 Equity Incentive Plan ("1999 Plan")
The aggregate number of shares of common stock authorized for issuance pursuant to the Company's 1999 Plan is 5,000,000 shares. There were 938 ,
10,938 and 30,438 stock options outstanding as of December 31, 2016 , 2015 and 2014 , respectively, under the 1999 Plan.
Impax Laboratories, Inc. Third Amended and Restated 2002 Equity Incentive Plan ("2002 Plan")
The aggregate number of shares of common stock authorized for issuance pursuant to the Company's 2002 Plan is 15,950,000 shares. There were
2,233,393 , 2,394,433 and 3,006,367 stock options outstanding as of December 31, 2016 , 2015 and 2014 , respectively, and 2,160,127 , 2,146,498 and 2,327,176
non-vested restricted stock awards outstanding as of December 31, 2016 , 2015 and 2014 , respectively, under the 2002 Plan.
The stock option activity for all of the Company’s equity compensation plans noted above is summarized as follows:
Stock Options
Outstanding at December 31, 2013
Options granted
Options exercised
Options forfeited
Outstanding at December 31, 2014
Options granted
Options exercised
Options forfeited
Outstanding at December 31, 2015
Options granted
Options exercised
Options forfeited
Outstanding at December 31, 2016
Options exercisable at December 31, 2016
F-41
Weighted-
Average
Exercise
Price
per Share
Number of Shares
Under Option
3,770,905 $
386,600
(778,112)
(337,213)
3,042,180 $
406,950
(1,042,198)
(1,561)
2,405,371 $
572,625
(477,910)
(265,755)
2,234,331 $
1,536,879 $
14.01
25.27
13.76
20.48
14.78
41.27
9.87
16.70
21.39
12.27
19.09
35.88
22.67
18.71
In May 2016, a retiring member of the Company's Board of Directors exercised vested stock options on a cashless basis, whereby the Company withheld
19,022 shares to cover the $0.6 million of proceeds due to the Company, representing the aggregate exercise price of the options.
As of December 31, 2016 , stock options outstanding and exercisable had average remaining contractual lives of 6.65 years and 5.69 years, respectively.
Also, as of December 31, 2016 , stock options outstanding and exercisable each had aggregate intrinsic values of $3.2 million and $3.1 million , respectively, and
restricted stock awards outstanding had an aggregate intrinsic value of $28.6 million . As of December 31, 2016 , the Company estimated there were 1,978,038
stock options and 1,912,345 shares of restricted stock granted to employees and service providers which had vested or were expected to vest.
The Company grants restricted stock to certain eligible employees as a component of its long-term incentive compensation program. The restricted stock
award grants are made in accordance with the Company’s 2002 Plan and are issued and outstanding at the time of grant but are subject to forfeiture if the vesting
conditions are not met. A summary of the non-vested restricted stock awards is as follows:
Restricted Stock Awards
Non-vested at December 31, 2013
Granted
Vested
Forfeited
Non-vested at December 31, 2014
Granted
Vested
Forfeited
Non-vested at December 31, 2015
Granted
Vested
Forfeited
Non-vested at December 31, 2016
Non-Vested
Restricted
Stock
Awards
Weighted-
Average
Grant Date
Fair Value
2,123,835 $
1,449,585
(796,966)
(449,278)
2,327,176 $
973,742
(930,159)
(224,261)
2,146,498 $
1,245,184
(893,190)
(338,365)
2,160,127 $
21.13
25.35
21.36
21.47
23.61
45.40
22.64
29.01
33.20
31.77
28.97
33.87
34.02
Included in the 893,190 shares of restricted stock vested during the year ended December 31, 2016 are 355,423 shares with a weighted-average fair value
of $27.69 per share that were withheld for minimum withholding tax purposes upon vesting of such awards from stockholders who elected to net share settle such
tax withholding obligation. Included in the 930,159 shares of restricted stock vested during the year ended December 31, 2015 are 370,449 shares with a weighted-
average fair value of $40.48 per share that were withheld for minimum withholding tax purposes upon vesting of such awards from stockholders who elected to net
share settle such tax withholding obligation.
As of December 31, 2016 , the Company had 1,739,672 shares available for issuance for either stock options or restricted stock awards, including
1,391,113 shares from the 2002 Plan, 296,921 shares from the 1999 Plan, and 51,638 shares from the 2001 Non-Qualified Employee Stock Purchase Plan
(“ESPP”) Plan.
As of December 31, 2016 , the Company had total unrecognized share-based compensation expense, net of estimated forfeitures, of $58.9 million related
to all of its share-based awards, which is expected to be recognized over a weighted average period of 2.21 years. The intrinsic value of options exercised during
the years ended December 31, 2016 , 2015 and 2014 was $5.8 million , $33.0 million and $10.4 million , respectively. The total fair value of restricted stock which
vested during the years ended December 31, 2016 , 2015 and 2014 was $25.9 million , $21.1 million and $17.0 million , respectively.
F-42
The Company estimated the fair value of each stock option award on the grant date using the Black-Scholes option pricing model with the following
assumptions:
Volatility (range)
Volatility (weighted average)
Risk-free interest rate (range)
Risk-free interest rate (weighted average)
Dividend yield
Weighted-average expected life (years)
Weighted average grant date fair value
Years Ended December 31,
38.1%
1.2%
2016
-
38.3%
-
1.4%
—%
6.14
$12.27
40.3%
39.9%
1.9%
0.8%
2015
-
40.0%
-
1.7%
—%
6.18
$17.08
40.1%
40.1%
1.8%
0.6%
41.7%
1.9%
2014
-
40.2%
-
1.8%
—%
6.07
$10.45
The Company estimated the fair value of each stock option award on the grant date using the Black-Scholes option pricing model, wherein expected
volatility is based on historical volatility of the Company’s common stock. The expected term calculation is based on the “simplified” method described in SAB
No. 107, Share-Based Payments and SAB No. 110, Share-Based Payment, as the result of the simplified method provides a reasonable estimate in comparison to
actual experience. The risk-free interest rate is based on the U.S. Treasury yield at the date of grant for an instrument with a maturity that is commensurate with the
expected term of the stock options. The dividend yield of zero is based on the fact that the Company has never paid cash dividends on its common stock and has no
present intention to pay cash dividends. Options granted under each of the above plans generally vest over four years and have a term of 10 years.
The amount of share-based compensation expense recognized by the Company is as follows (in thousands):
Manufacturing expenses
Research and development
Selling, general and administrative
Total
Years Ended December 31,
2016
2015
2014
$
$
6,364 $
4,479 $
5,697
20,119
5,996
18,138
32,180 $
28,613 $
2,494
5,072
13,317
20,883
The after tax impact of recognizing the share-based compensation expense related to FASB ASC Topic 718 on basic earnings per common share was
$0.31 , $0.20 and $0.20 for the years ended December 31, 2016 , 2015 and 2014 , respectively, and diluted earnings per common share was $0.31 , $0.20 and $0.20
for the years ended December 31, 2016 , 2015 and 2014 , respectively. The Company recognized a deferred tax benefit of $9.6 million , $9.2 million and $6.9
million in the years ended December 31, 2016 , 2015 and 2014 , respectively, related to share-based compensation expense recorded for non-qualified employee
stock options and restricted stock awards.
The Company’s policy is to issue new shares to satisfy stock option exercises and to grant restricted stock awards.
Share based Compensation Expense related to Former Executives
In December 2016, the Company announced that G. Frederick Wilkinson and the Company mutually agreed that Mr. Wilkinson would separate from his
positions as President and Chief Executive Officer of Impax and resign as a member of the Board of Directors of the Company, effective December 19, 2016. In
connection with his separation from the Company, Mr. Wilkinson and the Company entered into a General Release and Waiver dated as of December 19, 2016 (the
“General Release and Waiver”). The General Release and Waiver provided for 12 month accelerated vesting of certain of Mr. Wilkinson's stock options and shares
of restricted stock in accordance with the terms therein. As a result, during the year ended December 31, 2016, the Company recorded $0.5 million of accelerated
expense related to the accelerated vesting of certain of Mr. Wilkinson's outstanding stock options and restricted stock.
F-43
The Company appointed Mr. Wilkinson as its President and Chief Executive Officer effective as of April 29, 2014. In accordance with Mr. Wilkinson’s
appointment and pursuant to Mr. Wilkinson’s employment agreement with the Company, the Company granted to Mr. Wilkinson 150,000 shares of the Company’s
restricted stock with a grant date fair value of $3.9 million , which vested as to one-third of the underlying shares on each of the six, 12 and 18 month anniversaries
of April 29, 2014. Mr. Wilkinson also received pursuant to his employment agreement with the Company an award of 375,000 shares of restricted stock. The
performance goals were achieved during fiscal year 2015 and pursuant to the terms of the employment agreement, 50% of Mr. Wilkinson’s performance-based
restricted stock vested in 2015 and 50% vested in 2016. The Company valued these restricted stock awards subject to performance-based vesting using a Monte
Carlo simulation and recognized the $7.6 million value of these awards over the longer of the derived or explicit service period, which was two years.
On October 22, 2014, the Company announced that Carole S. Ben-Maimon, M.D., then President of the Company’s Impax Generics division, informed
the Company of her decision to retire from her position effective November 3, 2014. Pursuant to her Separation Agreement, all option grants and restricted stock
grants expected to vest in the 12 month period following her retirement date were accelerated and vested as of the retirement date. As a result, during the three
month period ended December 31, 2014, the Company recorded $0.5 million of accelerated expense related to Dr. Ben-Maimon’s outstanding stock options and
restricted stock.
17. EMPLOYEE BENEFIT PLANS
401(k) Defined Contribution Plan
The Company sponsors a 401(k) defined contribution plan covering all employees. Participants are permitted to contribute up to 25% of their eligible
annual pre-tax compensation up to established federal limits on aggregate participant contributions. Prior to January 1, 2015, the Company matched 50% of the
employee contributions up to a maximum of 6% of employee compensation. Effective January 1, 2015, the Company updated its 401(k) policy to match 100% of
the employee contributions up to a maximum of 5% of employee compensation. Discretionary profit-sharing contributions made by the Company, if any, are
determined annually by the Board of Directors. Participants are 100% vested in discretionary profit-sharing and matching contributions made by the Company after
three years of service, and are 25% and 50% vested after one and two years of service, respectively. There were $7.4 million , $3.7 million and $1.6 million in
matching contributions and no discretionary profit-sharing contributions made under this plan for the years ended December 31, 2016 , 2015 and 2014 ,
respectively.
Employee Stock Purchase Plan
In February 2001, the Board of Directors approved the 2001 Non-Qualified Employee Stock Purchase Plan (“ESPP”), with a 500,000 share reservation.
The purpose of the ESPP is to enhance employee interest in the success and progress of the Company by encouraging employee ownership of common stock of the
Company. The ESPP provides the opportunity to purchase the Company’s common stock at a 15% discount to the market price through payroll deductions or lump
sum cash investments. Under the ESPP plan, for the years ended December 31, 2016 , 2015 and 2014 , the Company sold shares of its common stock to its
employees in the amount of 29,612 , 35,275 and 35,350 , respectively, for net proceeds of $0.7 million , $1.2 million and $0.8 million , respectively.
Deferred Compensation Plan
In February 2002, the Board of Directors approved the Executive Non-Qualified Deferred Compensation Plan (“ENQDCP”) effective August 15, 2002
covering executive level employees of the Company as designated by the Board of Directors. Participants can defer up to 75% of their base salary and quarterly
sales bonus and up to 100% of their annual performance based bonus. The Company matches 50% of employee deferrals up to 10% of base salary and bonus
compensation. The maximum total match by the Company cannot exceed 5% of total base and bonus compensation. Participants are vested in the employer match
contribution at 20% each year, with 100% vesting after five years of employment. Participants can earn a return on their deferred compensation based on
hypothetical investments in investment funds. Changes in the market value of the participant deferrals and earnings thereon are reflected as an adjustment to the
liability for deferred compensation with an offset to compensation expense. There were $1.0 million , $1.1 million and $0.9 million in matching contributions
under the ENQDCP for the years ended December 31, 2016 , 2015 and 2014 , respectively.
F-44
The deferred compensation liability is a non-current liability recorded at the value of the amount owed to the ENQDCP participants, with changes in the
value of such amounts recognized as compensation expense in the consolidated statements of operations. The calculation of the deferred compensation obligation
is derived from observable market data by references to hypothetical investments selected by the participants and is included in the line item captioned “Other
liabilities” on the consolidated balance sheets. The Company invests in corporate owned life insurance (“COLI”) policies, of which the cash surrender value is
included in the line item captioned “Other assets” on the consolidated balance sheets. As of December 31, 2016 and 2015 , the Company had a cash surrender
value asset of $37.4 million and $30.7 million , respectively, and a deferred compensation liability of $28.6 million and $25.6 million , respectively, which
approximated fair value. The asset representing the cash surrender value of the corporate owned life insurance and the deferred compensation liability are both
Level 2 fair value measurements.
18. RESTRUCTURINGS
Middlesex, New Jersey Manufacturing and Packaging Operations
In March 2016, the Company's Board of Directors approved a plan of restructuring designed to reduce costs, improve operating efficiencies and enhance
the Company's long-term competitive position by closing the Company's Middlesex, New Jersey manufacturing and packaging site and transferring the products
and the functions performed there to the Company's other facilities or to third-party manufacturers. This plan will take up to two years to complete. In August
2016, the Company's Board of Directors approved a plan to repurpose a part of the Middlesex manufacturing site as a research and development pilot plant in an
effort to expand capacity for the number of generic projects in the Company's pipeline. As a result, approximately 28 employees that were previously expected to
be terminated will be retained, reducing the number of positions expected to be eliminated to 187 .
Management currently estimates that through mid-2018 the Company will incur aggregate pre-tax charges in connection with this plan of $43.9 million ,
of which approximately half were incurred in the fourth quarter of 2016 and the remainder by the second quarter of 2018. The following is a summary of the total
estimated charges to be incurred by major type of cost (in millions):
Type of Cost
Employee retention and severance payments
Technical transfer of products
Asset impairment and accelerated depreciation charges
Facilities lease terminations and asset retirement obligations
Legal and professional fees
Total estimated restructuring charges
$
$
Amount Expected to be
Incurred
13.4
11.2
18.0
1.0
0.3
43.9
Employee retention and severance payments are being accrued over the estimated service period. For the year ended December 31, 2016 , the Company
recorded $27.1 million of expense to cost of revenues on the consolidated statement of operations.
A rollforward of the charges incurred for the year ended December 31, 2016 is as follows (in thousands):
Balance as of
Expensed/
Cash
Non-Cash
Balance as of
December 31, 2015
Accrued Expense
Payments
Items
December 31, 2016
Employee retention and severance payments $
Technical transfer of products
Asset impairment and accelerated
depreciation charges
Facilities lease terminations and asset
retirement obligations
Legal and professional fees
— $
—
—
—
—
6,636 $
6,573
(691) $
(6,573)
— $
—
13,678
209
12
—
—
(12)
(13,678)
—
—
Total
$
— $
27,108 $
(7,276) $
(13,678) $
5,945
—
—
209
—
6,154
F-45
Hayward, California Technical Operations and R&D
In November 2015, the Company's management assessed the headcount in the technical operations and research and development groups in Hayward,
California, primarily as a result of the resolution of the warning letter at the Hayward facility, and determined that a reduction-in-force was necessary to adjust the
headcount to the operating conditions of the post-warning letter resolution environment. The Company eliminated 27 positions and recorded an accrual for
severance and related employee termination benefits of $2.5 million during the quarter ended December 31, 2015. As of December 31, 2016 , $2.3 million has
been paid, and the Company currently expects the remainder of this balance to be paid by early 2017.
Philadelphia, Pennsylvania Packaging and Distribution Operations
On June 30, 2015, the Company committed to a plan of restructuring of its packaging and distribution operations and as a result of this plan, the Company
closed its Philadelphia packaging site and all Company-wide distribution operations were outsourced to United Parcel Services during the fiscal year ended
December 31, 2015. The Company eliminated 93 positions and recorded an accrual for severance and related employee termination benefits of $2.6 million during
the quarter ended June 30, 2015. As of June 30, 2016, the full $2.6 million had been paid.
Workforce Reduction
On October 30, 2014, the Company committed to a reduction in the Company’s workforce, eliminating approximately 41 positions, including 35
positions in the Company’s research and development (“R&D”) organization. The reduction in workforce is part of the Company’s reorganization of its R&D
organizations by consolidating the product development and analytical functions of the generic and brand R&D organizations. The workforce reduction resulted in
charges of $2.1 million for severance and related termination costs, which were recorded during the quarter ended December 31, 2014. As of December 31, 2015,
all accrued severance and related termination costs had been paid.
19. INCOME TAXES
The Company is subject to federal, state and local income taxes in the United States, and income taxes in Taiwan, R.O.C., the Republic of Ireland and the
Netherlands. The (benefit from) provision for income taxes is comprised of the following (in thousands):
Current:
Federal taxes
State taxes
Foreign taxes
Total current tax expense
Deferred:
Federal taxes
State taxes
Foreign taxes
Total deferred tax (benefit) expense
(Benefit from) provision for income taxes
Years Ended December 31,
2016
2015
2014
$
$
$
21,386 $
48,078 $
266
1,377
23,029
2,286
(442)
49,922
(133,387) $
(23,605) $
5,502
562
(127,323)
(5,733)
(213)
(29,551)
42,635
2,467
832
45,934
(9,039)
(3,597)
(92)
(12,728)
(104,294) $
20,371 $
33,206
F-46
A reconciliation of the difference between the tax provision at the federal statutory rate and actual income taxes on income before income taxes, which
includes federal, state, and other income taxes, is as follows (in thousands):
(Loss) income before income taxes
$
(576,325)
$
59,368
$
90,559
Tax (benefit) provision at the federal statutory rate
(201,714)
35.0 %
20,779
35.0 %
31,696
35.0 %
2016
2015
2014
Years Ended December 31,
Increase (decrease) in tax rate resulting from:
Tax rate differential and permanent items on
foreign income
State income taxes, net of federal benefit
State research and development credits
Federal research and development credits
Share-based compensation
Executive compensation
Domestic manufacturing deduction
Other permanent book/tax differences
Provision for uncertain tax positions
Revision of prior years’ estimates
Taiwan Rural Area Investment Tax Credit
Other, net
Valuation allowance
186
(7,394)
(1,767)
(2,213)
1,768
(761)
(1,286)
(258)
337
(792)
—
842
108,758
— %
1.3 %
0.3 %
0.4 %
(0.3)%
0.1 %
0.2 %
— %
— %
0.1 %
— %
(0.1)%
(18.9)%
412
365
(2,357)
(2,672)
968
3,140
(1,422)
2,003
184
859
(2,134)
246
—
0.7 %
0.6 %
(4.0)%
(4.5)%
1.6 %
5.3 %
(2.4)%
3.4 %
0.3 %
1.5 %
(3.6)%
0.4 %
— %
2,285
887
(2,133)
(2,401)
189
1,552
(679)
170
952
664
—
24
—
2.5 %
1.0 %
(2.4)%
(2.6)%
0.2 %
1.7 %
(0.7)%
0.2 %
1.1 %
0.7 %
— %
— %
— %
(Benefit from) provision for income taxes
$
(104,294)
18.1 % $
20,371
34.3 % $
33,206
36.7 %
Deferred income taxes result from temporary differences between the financial statement carrying values and the tax bases of the Company’s assets and
liabilities. Deferred tax assets principally result from certain accruals and reserves currently not deductible for tax purposes, acquired product rights and
intangibles, capitalized legal and share based compensation expense. Deferred tax liabilities principally result from acquired product rights and intangibles and the
use of accelerated depreciation methods for income tax purposes.
A valuation allowance, if needed, reduces deferred tax assets to the amount expected to be realized. When determining the amount of net deferred tax
assets that are more likely than not to be realized, the Company assesses all available positive and negative evidence. This evidence includes, but is not limited to,
scheduled reversal of deferred tax liabilities, prior earnings history, projected future earnings, carry-back and carry-forward periods and the feasibility of ongoing
tax strategies that could potentially enhance the likelihood of the realization of a deferred tax asset. The weight given to the positive and negative evidence is
commensurate with the extent the evidence may be objectively verified. As such, it is generally difficult for positive evidence regarding projected future taxable
income (exclusive of reversing taxable temporary differences and carryforwards) to outweigh objective negative evidence of a recent financial reporting loss for
the year ended December 31, 2016.
Based on an evaluation of both the positive and negative evidence available, the Company determined that it was necessary to establish a valuation
allowance against a significant portion of the net deferred tax assets for the year ended December 31, 2016. Given the objectively verifiable negative evidence of a
three-year cumulative loss which, under the provisions of FASB ASC Topic 740 is a significant element of negative evidence that is difficult to overcome, and the
weighting of all available positive evidence, the Company excluded projected taxable income from the assessment of income that could be used as a source of
taxable income to realize the deferred tax assets. The valuation allowance recorded against the consolidated net deferred tax asset in 2016 was $108.8 million .
F-47
The components of the Company’s deferred tax assets and liabilities are as follows (in thousands):
Deferred tax assets:
Accrued expenses
Inventory reserves
Net operating loss carryforwards
Depreciation and amortization
Acquired product rights and intangibles
Capitalized legal fees
Credit carryforwards
Share based compensation expense
Other
Deferred tax assets
Deferred tax liabilities:
Tax depreciation and amortization in excess of book amounts
Acquired product rights and intangibles
Deferred manufacturing costs
Derivative
Other
Deferred tax liabilities
Deferred tax assets (liabilities), net
Valuation allowance
Deferred tax assets (liabilities), net after valuation allowance
December 31,
2016
2015
$
114,825 $
15,873
2,302
651
128,401
10,231
8,453
6,371
525
83,414
9,585
38
362
20,912
7,352
6,149
5,471
389
$
$
$
$
$
287,632 $
133,672
5,428 $
95,517
64
6,192
1,807
7,367
188,018
65
8,894
1,783
109,008 $
206,127
178,624 $
(72,455)
(108,758)
69,866 $
—
(72,455)
A rollforward of unrecognized tax benefits for the years ended December 31, 2016 , 2015 and 2014 is as follows (in thousands):
Unrecognized tax benefits beginning of year
Gross change for current year positions
Gross change for prior period positions
Gross change due to Tower Acquisition
Decrease due to settlements and payments
Unrecognized tax benefits end of year
Years Ended December 31,
2016
2015
2014
5,680 $
6,517 $
549
1,318
—
(1,122)
1,079
(673)
1,037
(2,280)
6,425 $
5,680 $
5,292
1,089
310
—
(174)
6,517
$
$
The amount of unrecognized tax benefits at December 31, 2016 , 2015 and 2014 was $6.4 million , $5.7 million and $6.5 million respectively, of which
$5.3 million , $4.3 million and $5.0 million would impact the Company’s effective tax rate, respectively, if recognized. The Company currently does not believe
that the total amount of unrecognized tax benefits will increase or decrease significantly over the next 12 months. Interest expense related to income taxes is
included in “Interest expense” on the consolidated statements of operations. Net interest expense related to unrecognized tax benefits for the year ended
December 31, 2016 was $125,000 , compared to $8,000 in 2015 . Accrued interest expense as of December 31, 2016 and 2015 was $0.4 million and $0.6 million,
respectively. Income tax penalties are included in “Other income (expense)” on the consolidated statements of operations. Accrued tax penalties of $0.6 million
were booked in 2015 related to the 2010-2011 California audit and were paid in 2016.
F-48
The Company is currently not under audit for its federal income tax. As of December 31, 2016, no provision has been made for U.S. federal deferred
income taxes on the excess of the amount for financial reporting over the tax basis of investments in foreign subsidiaries since it is the current intention of
management to indefinitely reinvest the undistributed earnings in the foreign subsidiary. Determination of the amount of any unrecognized deferred income tax
liability on this temporary difference is not practicable because of the complexities of the hypothetical calculation.
20. ALLIANCE AND COLLABORATION AGREEMENTS
The Company has entered into several alliance, collaboration, license and distribution agreements, and similar agreements with respect to certain of its
products and services, with unrelated third-party pharmaceutical companies. The consolidated statements of operations include revenue recognized under
agreements the Company has entered into to develop marketing and/or distribution relationships with its partners to fully leverage the technology platform and
revenue recognized under development agreements which generally obligate the Company to provide research and development services over multiple periods.
The Company’s alliance and collaboration agreements often include milestones and provide for milestone payments upon achievement of these
milestones. Generally, the milestone events contained in the Company’s alliance and collaboration agreements coincide with the progression of the Company’s
products and technologies from pre-commercialization to commercialization.
The Company groups pre-commercialization milestones in its alliance and collaboration agreements into clinical and regulatory categories, each of which
may include the following types of events:
Clinical Milestone Events:
•
•
•
•
•
Designation of a development candidate . Following the designation of a development candidate, generally, IND-enabling animal studies for a new
development candidate take 12 to 18 months to complete.
Initiation of a Phase I clinical trial . Generally, Phase I clinical trials take one to two years to complete.
Initiation or completion of a Phase II clinical trial . Generally, Phase II clinical trials take one to three years to complete.
Initiation or completion of a Phase III clinical trial . Generally, Phase III clinical trials take two to four years to complete.
Completion of a bioequivalence study . Generally, bioequivalence studies take three months to one year to complete.
Regulatory Milestone Events:
•
Filing or acceptance of regulatory applications for marketing approval such as a New Drug Application in the United States or Marketing
Authorization Application in Europe . Generally, it takes six to 12 months to prepare and submit regulatory filings and two months for a regulatory
filing to be accepted for substantive review.
• Marketing approval in a major market, such as the United States or Europe . Generally it takes one to three years after an application is submitted to
obtain approval from the applicable regulatory agency.
• Marketing approval in a major market, such as the United States or Europe for a new indication of an already-approved product . Generally it takes
one to three years after an application for a new indication is submitted to obtain approval from the applicable regulatory agency.
Commercialization Milestone Events:
•
•
First commercial sale in a particular market , such as in the United States or Europe .
Product sales in excess of a pre-specified threshold , such as annual sales exceeding $100 million . The amount of time to achieve this type of
milestone depends on several factors including but not limited to the dollar amount of the threshold, the pricing of the product and the pace at which
customers begin using the product.
F-49
License and Distribution Agreement with Shire
In January 2006, the Company entered into a License and Distribution Agreement with an affiliate of Shire Laboratories, Inc., which was subsequently
amended (“Prior Shire Agreement”), under which the Company received a non-exclusive license to market and sell an authorized generic of Shire’s Adderall XR®
product (“AG Product”) subject to certain conditions, but in any event by no later than January 1, 2010. The Company commenced sales of the AG Product in
October 2009. On February 7, 2013, the Company entered into an Amended and Restated License and Distribution Agreement with Shire (the “Amended and
Restated Shire Agreement”), which amended and restated the Prior Shire Agreement. The Amended and Restated Shire Agreement was entered into by the parties
in connection with the settlement of the Company’s litigation with Shire relating to Shire’s supply of the AG Product to the Company under the Prior Shire
Agreement. Under the Amended and Restated Shire Agreement, Shire was required to supply the AG Product and Company was responsible for marketing and
selling the AG Product subject to the terms and conditions thereof until the earlier of (i) the first commercial sale of the Company’s generic equivalent product to
Adderall XR® and (ii) September 30, 2014 (the “Supply Term”), subject to certain continuing obligations of the parties upon expiration or early termination of the
Supply Term, including Shire’s obligation to deliver AG Products still owed to the Company as of the end of the Supply Term. The Company is required to pay a
profit share to Shire on sales of the AG Product, of which the Company owed a profit share payable to Shire of $7.5 million , $19.5 million and $21.1 million on
sales of the AG Product during the years ended December 31, 2016 , 2015 and 2014 , respectively, with a corresponding charge included in the cost of revenues
line in the consolidated statements of operations. Although the Supply Term expired on September 30, 2014, the Company was permitted to sell any AG Products
in its inventory or owed to the Company by Shire under the Amended and Restated Shire Agreement until all such products are sold. The Company sold all
remaining AG Products in its inventory during the year ended December 31, 2016. The Company continued to pay a profit share to Shire on sales of such products
during the year ended December 31, 2016 .
Development, Supply and Distribution Agreement with Tolmar, Inc.
In June 2012, the Company entered into the Tolmar Agreement with Tolmar. Under the terms of the Tolmar Agreement, Tolmar granted to the Company
an exclusive license to commercialize up to 11 generic topical prescription drug products, including ten currently approved products in the United States and its
territories; the parties agreed in 2015 to terminate development efforts of one product under the Tolmar Agreement that had been pending approval at the FDA.
Under the terms of the Tolmar Agreement, Tolmar is responsible for developing and manufacturing the products, and the Company is responsible for marketing
and sale of the products. As of December 31, 2016 , the Company was currently marketing and selling four approved products. The Company is required to pay a
profit share to Tolmar on sales of each product commercialized pursuant to the terms of the Tolmar Agreement.
The Company paid Tolmar a $21.0 million upfront payment upon signing of the agreement and, pursuant to the terms of the agreement, is also required to
make payments to Tolmar up to an aggregate amount of $25.0 million upon the achievement of certain specified milestone events. The contingent milestone
payments are initially recognized in the period the triggering event occurs. Milestone payments which are contingent upon commercialization events are accounted
for as an additional cost of acquiring the product license rights. Milestone payments which are contingent upon regulatory approval events are capitalized and
amortized over the remaining estimated useful life of the approved product. As of December 31, 2016, the Company had paid a total of $20.0 million to Tolmar
upon the achievement of certain specified milestone events, including $12.0 million upon the achievement of a regulatory milestone event and $5.0 million upon
the achievement of a commercialization event, and does not currently expect to make any additional milestone payments under the agreement. The $21.0 million
upfront payment for the Tolmar product rights has been allocated to the underlying topical products based upon the relative fair value of each product and will be
amortized over the remaining estimated useful life of each underlying product, ranging from five to 12 years, starting upon commencement of commercialization
activities by the Company during the second half of 2012. The amortization of the Tolmar product rights has been included as a component of cost of revenues on
the consolidated statements of operations. The Company is also required to pay a profit share to Tolmar on sales of the topical products, of which the Company
owed a profit share payable to Tolmar of $36.4 million , $77.7 million and $16.0 million during the years ended December 31, 2016 , 2015 and 2014 , respectively,
with a corresponding charge included in the cost of revenues line in the Company’s consolidated statement of operations.
The Company entered into a Loan and Security Agreement with Tolmar in March 2012 (the “Tolmar Loan Agreement”), under which the Company
agreed to lend to Tolmar one or more loans through December 31, 2014, in an aggregate amount not to exceed $15.0 million . The outstanding principal amount of,
including any accrued and unpaid interest on, the loans under the Tolmar Loan Agreement are payable by Tolmar beginning from March 31, 2017 through March
31, 2020 or the maturity date, in accordance with the terms therein. Pursuant to the Tolmar Loan Agreement, Tolmar could prepay all or any portion of the
outstanding balance of the loans prior to the maturity date without penalty or premium. In May 2016, Tolmar repaid in full the $15.0 million due to the Company
under the Tolmar Loan Agreement.
F-50
Strategic Alliance Agreement with Teva
The Company is a party to a Strategic Alliance Agreement dated as of June 27, 2001 with Teva Pharmaceuticals USA, Inc. ("Teva USA"), an affiliate of
Teva, which was subsequently amended (“Teva Agreement”). The Teva Agreement commits the Company to develop and manufacture, and Teva to distribute, a
specified number of controlled release generic pharmaceutical products (“generic products”), each for a 10 -year period. The Company is required to develop the
products, obtain FDA approval to market the products, and manufacture the products for Teva. The revenue the Company earns from the sale of product under the
Teva Agreement consists of Teva’s reimbursement of the Company’s manufacturing costs plus a profit share on Teva’s sales of the product to its customers. The
Company invoices Teva for the manufacturing costs or products it ships to Teva and payment is due within 30 days. Teva has the right to determine all terms and
conditions of the product sales to its customers. Within 30 days of the end of each calendar quarter, Teva is required to provide the Company with a report of its net
sales and profits during the quarter and to pay the Company its share of the profits resulting from those sales. Net sales are Teva’s gross sales less discounts,
rebates, chargebacks, returns, and other adjustments, all of which are based upon fixed percentages, except chargebacks, which are estimated by Teva and subject
to a true-up reconciliation.
As of December 31, 2016 , the Company was supplying Teva with oxybutynin extended release tablets (Ditropan XL® 5 mg, 10 mg and 15 mg extended
release tablets); the other products under the Teva Agreement have either been returned to the Company, are being manufactured by Teva at its election, were
voluntarily withdrawn from the market or the Company’s obligations to supply such product had expired or were terminated in accordance with the Teva
Agreement. Further, in connection with the Teva Transaction and as described in “Note 2. Business Acquisitions”, the Company and Teva terminated each party’s
rights and obligations under the Teva Agreement effective on August 3, 2016 with respect to the methylphenidate hydrochloride product (generic Concerta ® ).
OTC Partner Alliance Agreement
In June 2002, the Company entered into a Development, License and Supply Agreement with Pfizer, Inc., formerly Wyeth LLC (“Pfizer”), for a term of
15 years, relating to the Company’s Loratadine and Pseudoephedrine Sulfate 5 mg/120 mg 12-hour Extended Release Tablets (the "D12 Product") and Loratadine
and Pseudoephedrine Sulfate 10 mg/240 mg 24-hour Extended Release Tablets for the OTC market (the "D24 Product"); the agreement was terminated with
respect to the D24 Product in 2005. The Company previously developed the products and is currently only responsible for manufacturing the products. Pfizer is
responsible for marketing and sale of the products. The agreement included payments to the Company upon achievement of development milestones, as well as
royalties paid to the Company by Pfizer on its sales of the product. Pfizer launched this product in May 2003 as Alavert® D-12 Hour. In December 2011, the
Company and Pfizer entered into an agreement with L. Perrigo Company (“Perrigo”), which was subsequently amended whereby the parties agreed that the
Company would supply the Company’s D-12 Product to Perrigo in the United States and its territories. The agreements with Pfizer and Perrigo are no longer a core
area of the Company’s business, and the over-the-counter pharmaceutical products the Company sells to Pfizer and Perrigo under the agreements are older
products which are only sold to Pfizer and Perrigo. The Company recognizes profit share revenue in the period earned.
During the quarter ended September 30, 2016, the Company sold the ANDAs for both the D12 Product and the D24 Product, in addition to other specified
assets, to Perrigo pursuant to an asset purchase agreement with Perrigo dated as of March 31, 2016 (the "Perrigo APA"). Under the terms of the Perrigo APA, the
Company will also continue to supply the D-12 Product to Pfizer and Perrigo until the date that is the earliest of (i) the date Perrigo’s manufacturing facility is
approved to manufacture the D-12 Product and (ii) December 31, 2017 (the "Supply End Date"). On the Supply End Date, the Company will assign and transfer its
supply agreement with Pfizer in its entirety to Perrigo in accordance with the Perrigo APA.
Agreements with Valeant Pharmaceuticals International, Inc.
In November 2008, the Company and Valeant Pharmaceuticals International, Inc., formerly Medicis Pharmaceutical Corporation (“Valeant”), entered into
a Joint Development Agreement and a License and Settlement Agreement (“Joint Development Agreement”). The Joint Development Agreement provides for the
Company and Valeant to collaborate in the development of a total of five dermatology products, including four of the Company’s generic products and one
branded advanced form of Valeant’s Solodyn® product. Under the provisions of the Joint Development Agreement the Company has the potential to receive up to
an additional $8.0 million of contingent milestone payments each of which the Company believes to be substantive, as well as the potential to receive royalty
payments from sales, if any, by Valeant of its advanced form Solodyn® brand product. Finally, to the extent the Company commercializes any of its four generic
dermatology products covered by the Joint Development Agreement, the Company will pay to Valeant a gross profit share on sales of such products. The Company
began selling one of the four generic dermatology products during the year ended December 31, 2011 and began selling a second dermatology product during the
quarter ended September 30, 2016.
F-51
The Joint Development Agreement results in three items of revenue for the Company, as follows:
(1) Research & Development Services. Revenue from the remaining $8.0 million of contingent milestone payments, will be recognized using the
Milestone Method of accounting. Revenue recognized under the Joint Development Agreement is included in “Note 24. Supplementary Financial
Information,” in the line item captioned “Other Revenues.”
(2) Royalty Fees Earned — Valeant’s Sale of Advanced Form Solodyn® (Brand) Product. Under the Joint Development Agreement, the Company
granted Valeant a license for the advanced form of the Solodyn® product, with the Company receiving royalty fee income under such license for a
period ending eight years after the first commercial sale of the advanced form Solodyn® product. Commercial sales of the new Solodyn® product, if
any, are expected to commence upon FDA approval of Valeant’s NDA. The royalty fee income, if any, from the new Solodyn® product, will be
recognized by the Company as current period revenue when earned.
(3) Accounting for Sales of the Company’s Four Generic Dermatology Products. Upon FDA approval of the Company’s ANDA for each of the four
generic products covered by the Joint Development Agreement, the Company will have the right (but not the obligation) to begin manufacture and
sale of its four generic dermatology products. The Company sells its manufactured generic products to all Impax Generics division customers in the
ordinary course of business through its Impax Generics Product sales channel. The Company accounts for the sale, if any, of the generic products
covered by the Joint Development Agreement as current period revenue according to the Company’s revenue recognition policy applicable to its
Impax Generics products. To the extent the Company sells any of the four generic dermatology products covered by the Joint Development
Agreement, the Company pays Valeant a gross profit share, with such profit share payments accounted for as a current period cost of revenues in the
consolidated statement of operations .
Distribution, License, Development and Supply Agreement with AstraZeneca UK Limited
In January 2012, the Company entered into the AZ Agreement with AstraZeneca and the parties subsequently entered into a First Amendment to the AZ
Agreement dated May 31, 2016 (as amended, the "AZ Amendment"). Under the terms of the AZ Agreement, AstraZeneca granted to the Company an exclusive
license to commercialize the tablet, orally disintegrating tablet and nasal spray formulations of Zomig® (zolmitriptan) products for the treatment of migraine
headaches in the United States and in certain U.S. territories, except during an initial transition period when AstraZeneca fulfilled all orders of Zomig® products
on the Company’s behalf and AstraZeneca paid to the Company the gross profit on such Zomig® products. The Company is obligated to fulfill certain minimum
requirements with respect to the promotion of currently approved Zomig® products as well as other dosage strengths of such products approved by the FDA in the
future. The Company may, but has no obligation to, develop and commercialize additional products containing zolmitriptan and additional indications for Zomig®,
subject to certain restrictions as set forth in the AZ Agreement. Subject to the terms of the AZ Agreement, the Company will be responsible for conducting clinical
studies and preparing regulatory filings related to the development of any such additional products and would bear all related costs. During the term of the AZ
Agreement, AstraZeneca will continue to be the holder of the NDA for existing Zomig® products, as well as any future dosage strengths thereof approved by the
FDA, and will be responsible for certain regulatory and quality-related activities for such Zomig® products. AstraZeneca will manufacture and supply Zomig®
products to the Company and the Company will purchase its requirements of Zomig® products from AstraZeneca until a date determined in the AZ Agreement.
Thereafter, AstraZeneca may terminate its supply obligations upon certain advance notice to the Company, in which case the Company would have the right to
manufacture or have manufactured its own requirements for the applicable Zomig® product. Under the terms of the AZ Amendment, under certain conditions and
depending on the nature and terms of the study agreed to with the FDA, the Company agreed to conduct, at its own expense, the juvenile toxicity study and
pediatric study required by the FDA under the Pediatric Research Equity Act (“PREA”) for approval of the nasal formulation of Zomig ® for the acute treatment of
migraine in pediatric patients ages six through eleven years old, as further described in the study protocol mutually agreed to by the parties (the “PREA Study”). In
consideration for the Company conducting the PREA Study at its own expense, the AZ Amendment provides for the total royalty payments payable by the
Company to AstraZeneca on net sales of Zomig ® products under the AZ Agreement to be reduced by certain specified amounts beginning from the quarter ended
June 30, 2016 and through the quarter ended December 31, 2020, with such reduced royalty amounts totaling an aggregate amount of $30.0 million . In the event
the royalty reduction amounts exceed the royalty payments payable by the Company to AstraZeneca pursuant to the AZ Agreement in any given quarter,
AstraZeneca will be required to pay the Company an amount equal to the difference between the royalty reduction amount and the royalty payment payable by the
Company to AstraZeneca. The Company’s commitment to perform the PREA Study may be terminated, without penalty, under certain circumstances as set forth
in the AZ Amendment.
F-52
Under the terms of the AZ Agreement, AstraZeneca was required to make payments to the Company representing 100% of the gross profit on sales of
AstraZeneca-labeled Zomig® products during the specified transition period. Beginning from January 2013, the Company has paid AstraZeneca tiered royalties on
net sales of branded Zomig® products, depending on brand exclusivity and subject to customary reductions and other terms and conditions set forth in the AZ
Agreement. The Company has also paid to AstraZeneca royalties based on gross profit from sales of authorized generic versions of the Zomig® products subject to
certain terms and conditions set forth in the AZ Agreement. In May 2013, the Company’s exclusivity period for branded Zomig® tablets and orally disintegrating
tablets expired and the Company launched authorized generic versions of those products in the United States. As discussed above, pursuant to the AZ Amendment,
the total royalty payments payable by the Company to AstraZeneca on net sales of Zomig ® products under the AZ Agreement is reduced by certain specified
amounts beginning from the quarter ended June 30, 2016 and through the quarter ended December 31, 2020, with such reduced royalty amounts totaling an
aggregate amount of $30.0 million . The Company owed a royalty payable to AstraZeneca of $17.2 million , $16.8 million and $14.3 million for the years ended
December 31, 2016 , 2015 and 2014 , respectively, with a corresponding charge included in the cost of revenues line on the consolidated statements of operations.
Agreement with DURECT Corporation
During the three month period ended March 31, 2014, the Company entered into an agreement with DURECT Corporation (“Durect”) granting the
Company the exclusive worldwide rights to develop and commercialize DURECT’s investigational transdermal bupivacaine patch for the treatment of pain
associated with post-herpetic neuralgia, referred to by the Company as IPX239. The Company paid Durect a $2.0 million up-front payment upon signing of the
agreement which the Company recognized immediately as research and development expense. The Company has the potential to pay up to an aggregate of $61.0
million in additional contingent milestone payments upon the achievement of certain specified development and commercialization events under the agreement. If
IPX239 is commercialized, the Company would also be required to pay a tiered royalty based on product sales.
Mebendazole Product Acquisition Agreement with Teva Pharmaceuticals USA, Inc.
In August 2013, the Company, through its Amedra Pharmaceuticals subsidiary, entered into a product acquisition agreement (the “Mebendazole Product
Acquisition Agreement”) with Teva pursuant to which the Company acquired the assets (including the ANDA and other regulatory materials) and related liabilities
related to Teva’s mebendazole tablet product in all dosage forms. Pursuant to the Mebendazole Product Acquisition Agreement, the Company was required to pay
certain milestone payments up to an aggregate amount of $3.5 million upon the approval and launch of the mebendazole tablet product; the Company paid the $3.5
million to Teva during the quarter ended March 31, 2016 upon the FDA's approval and the Company's subsequent launch of Emverm® (mebendazole) 100 mg
chewable tablets. The Company is also obligated to pay Teva a royalty payment based on net sales of Emverm®, including a specified annual minimum royalty
payment, subject to customary reductions and the other terms and conditions set forth in the Teva Product Acquisition Agreement.
21. COMMITMENTS AND CONTINGENCIES
Executive Employment Agreements
The Company is a party to employment and separation agreements with certain members of its executive management team that provide for severance
and other payments following termination of their employment for various reasons.
Lease Agreements
The Company leases land, office space, manufacturing, warehouse and research and development facilities, and equipment under non-cancelable
operating leases expiring between January 2017 and December 2027. Rent expense for the years ended December 31, 2016 , 2015 and 2014 was $4.9 million , $4.1
million and $2.2 million , respectively. The Company recognizes rent expense on a straight-line basis over the lease period. The Company also leases certain
equipment under various non-cancelable operating leases with various expiration dates between April 2017 and October 2021. Future minimum lease payments
under the non-cancelable operating leases are as follows (in thousands):
Years ending December 31,
2017
2018
2019
2020
2021
Thereafter
Total minimum lease payments
Purchase Order Commitments
$
$
5,439
5,470
3,682
2,270
2,056
11,274
30,191
As of December 31, 2016 , the Company had $129.1 million of open purchase order commitments, primarily for raw materials. The terms of these
purchase order commitments are generally less than one year in duration.
22. LEGAL AND REGULATORY MATTERS
Patent Litigation
There is substantial litigation in the pharmaceutical, biological, and biotechnology industries with respect to the manufacture, use, and sale of new
products which are the subject of conflicting patent and intellectual property claims. One or more patents often cover the brand name products for which the
Company is developing generic versions and the Company typically has patent rights covering the Company’s branded products.
Under federal law, when a drug developer files an ANDA for a generic drug seeking approval before expiration of a patent, which has been listed with the
FDA as covering the brand name product, the developer must certify its product will not infringe the listed patent(s) and/or the listed patent is invalid or
unenforceable (commonly referred to as a “Paragraph IV” certification). Notices of such certification must be provided to the patent holder, who may file a suit for
patent infringement within 45 days of the patent holder’s receipt of such notice. If the patent holder files suit within the 45 day period, the FDA can review and
approve the ANDA, but is prevented from granting final marketing approval of the product until a final judgment in the action has been rendered in favor of the
generic drug developer, or 30 months from the date the notice was received, whichever is sooner. The Company’s generic products division is typically subject to
patent infringement litigation brought by branded pharmaceutical manufacturers in connection with the Company’s Paragraph IV certifications seeking an order
delaying the approval of the Company’s ANDA until expiration of the patent(s) at issue in the litigation. Likewise, the Company’s branded products division is
currently involved in patent infringement litigation against generic drug manufacturers who have filed Paragraph IV certifications to market their generic drugs
prior to expiration of the Company’s patents at issue in the litigation.
The uncertainties inherent in patent litigation make the outcome of such litigation difficult to predict. For the Company’s generic products division, the
potential consequences in the event of an unfavorable outcome in such litigation include delaying launch of its generic products until patent expiration. If the
Company were to launch its generic product prior to successful resolution of a patent litigation, the Company could be liable for potential damages measured by
the profits lost by the branded product manufacturer rather than the profits earned by the Company if we are found to infringe a valid, enforceable patent. For the
Company’s branded products division, an unfavorable outcome may significantly accelerate generic competition ahead of expiration of the patents covering the
Company’s branded products. All such litigation typically involves significant expense.
The Company is generally responsible for all of the patent litigation fees and costs associated with current and future products not covered by its alliance
and collaboration agreements. The Company has agreed to share legal expenses with respect to third-party and Company products under the terms of certain of the
alliance and collaboration agreements. The Company records the costs of patent litigation as expense in the period when incurred for products it has developed, as
well as for products which are the subject of an alliance or collaboration agreement with a third-party.
Although the outcome and costs of the asserted and unasserted claims is difficult to predict, based on the information presently known to management, the
Company does not currently expect the ultimate liability, if any, for such matters to have a material adverse effect on its business, financial condition, results of
operations, or cash flows.
Patent Infringement Litigation
Endo Pharmaceuticals Inc. and Grunenthal GmbH v. Impax Laboratories, Inc. and ThoRx Laboratories, Inc. (Oxymorphone hydrochloride); Endo
Pharmaceuticals Inc. and Grunenthal GmbH v. Impax Laboratories, Inc. (Oxymorphone hydrochloride)
In November 2012, Endo Pharmaceuticals, Inc. and Grunenthal GmbH (collectively, “Endo”) filed suit against ThoRx Laboratories, Inc., a wholly owned
subsidiary of the Company (“ThoRx”), and the Company in the U.S. District Court for the Southern District of New York alleging patent infringement based on
the filing of ThoRx’s ANDA relating to Oxymorphone hydrochloride, Extended Release tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg, generic to
Opana ER®. In January 2013, Endo filed a separate suit against the Company in the U.S. District Court for the Southern District of New York alleging patent
infringement based on the filing of the Company’s ANDA relating to the same products. ThoRx and the Company filed an answer and counterclaims to the
November 2012 suit and the Company filed an answer and counterclaims with respect to the January 2013 suit. A bench trial was completed in April 2015. In June
2016, the Court entered an amended judgment in both cases that the products described in the Company’s and ThoRx’s ANDAs would, if marketed, infringe
certain claims of the patents asserted by Endo and Grunenthal. The Court also found that the asserted claims of patents owned by Endo were not invalid, but that
the asserted claims of patents owned by Grunenthal were invalid. As a result, the Court enjoined the Company and ThoRx from marketing their products until
expiration of the Endo patents in 2023. The Company and ThoRx are appealing the Court's judgment.
F-53
In November 2014, Endo Pharmaceuticals Inc. and Mallinckrodt LLC filed suit against the Company in the U.S. District Court for the District of
Delaware making additional allegations of patent infringement based on the filing of the Company’s Oxymorphone hydrochloride ANDA described above. Also in
November 2014, Endo and Mallinckrodt filed a separate suit in the U.S. District Court for the District of Delaware making additional allegations of patent
infringement based on the filing of ThoRx’s Oxymorphone hydrochloride ANDA described above. ThoRx and the Company filed an answer and counterclaim to
those suits in which they are named as a defendant. The cases are currently stayed.
In May 2016, Endo Pharmaceuticals Inc. filed suit against the Company in the U.S. District Court for the District of New Jersey, alleging that the
Company’s marketed oxymorphone hydrochloride tablets infringe certain patents owned by Endo. Endo’s complaint also alleges that the Company and Endo
entered into a settlement and license agreement with respect to these products, but that the Company later breached that contract and breached its implied duty of
good faith and fair dealing with respect to that agreement. Endo filed an amended complaint on August 1, 2016 and the Company filed a motion to dismiss the
complaint. On October 25, 2016, that motion was granted in part and denied in part. On October 31, 2016, the Company received a letter from Endo purporting to
terminate the settlement and license agreement for material breach. Discovery is underway. No trial date has been set.
Impax Laboratories Inc., et al. v. Lannett Holdings, Inc. and Lannett Company (Zomig®)
In July 2014, the Company filed suit against Lannett Holdings, Inc. and Lannett Company (collectively, “Lannett”) in the United States District Court for
the District of Delaware, alleging patent infringement based on the filing of the Lannett ANDA relating to Zolmitriptan Nasal Spray, 5mg, generic to Zomig®
Nasal Spray. Lannett filed an answer and counterclaims alleging non-infringement and invalidity in September 2014, and the Company filed an answer to the
counterclaims in October 2014. Trial occurred in early September 2016. Post-trial briefing has been completed. Lannett has indicated that they will not sell their
generic product to the Zomig® Nasal Spray before March 31, 2017, and the Court has indicated that it will render its decision on or before that date.
Impax Laboratories Inc., et al. v. Par Pharmaceutical, Inc. (Zomig®)
On September 23, 2016, the Company filed suit against Par Pharmaceutical, Inc. (“Par”) in the United States District Court for the District of Delaware,
alleging patent infringement based on the filing of the Par ANDA relating to Zolmitriptan Nasal Spray, 2.5 mg and 5 mg, generic to Zomig® Nasal Spray. On
October 12, 2016, the parties stipulated to stay the case pending the outcome of the related case, Impax Laboratories Inc., et al. v. Lannett matter described above.
As such, Par has not yet filed an answer or counterclaims to the Company’s complaint. The 30-month stay of approval for applicable to the Par ANDA has been
tolled pending resumption of this case.
Impax Laboratories Inc., et al. v. Actavis Laboratories, Inc. and Actavis Pharma Inc. (Rytary ® )
In September 2015, the Company filed suit against Actavis Laboratories, Inc. and Actavis Pharma Inc. (collectively, “Actavis”) in the United States
District Court for the District of New Jersey, alleging patent infringement based on the filing of the Actavis ANDA relating to carbidopa and levodopa extended
release capsules, generic to Rytary ® . In December 2016, the Company filed a related action alleging infringement of related, later-issued U.S. Patent No.
9,463,246, which was consolidated with the lead action. Actavis filed an answer and counterclaims on November 19, 2015 in the lead action and on January 13,
2017 in the related action. Fact discovery is proceeding and claim construction briefing has concluded. Trial is expected in the fall of 2017.
Sanofi-Aventis U.S. LLC, et al. v. Impax Laboratories, Inc.
On January 3, 2017, Sanofi-Aventis U.S. LLC, Aventisub LLC, Sanofi, and Genzyme Corporation filed suit against the Company in the United States
District Court for the District of Delaware alleging patent infringement based on the filing of the Company’s ANDA related to Teriflunomide Oral Tablets, 14 mg,
generic to Aubagio ® . The Company’s answer currently is due on March 27, 2017; no further schedule has been set.
F-54
Other Litigation Related to the Company’s Business
Solodyn ® Antitrust Class Actions
From July 2013 to January 2016, 18 complaints were filed as class actions on behalf of direct and indirect purchasers, as well as by certain direct
purchasers, against manufacturers of the brand drug Solodyn® and its generic equivalents, including the Company.
On July 22, 2013, Plaintiff United Food and Commercial Workers Local 1776 & Participating Employers Health and Welfare Fund, an indirect purchaser,
filed a class action complaint in the United States District Court for the Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On July 23, 2013, Plaintiff Rochester Drug Co-Operative, Inc., a direct purchaser, filed a class action complaint in the United States District Court for the
Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On August 1, 2013, Plaintiff International Union of Operating Engineers Local 132 Health and Welfare Fund, an indirect purchaser, filed a class action
complaint in the United States District Court for the Northern District of California on behalf of itself and others similarly situated. On August 29, 2013, this
Plaintiff withdrew its complaint from the United States District Court for the Northern District of California, and on August 30, 2013, re-filed the same complaint
in the United States Court for the Eastern District of Pennsylvania, on behalf of itself and others similarly situated.
On August 9, 2013, Plaintiff Local 274 Health & Welfare Fund, an indirect purchaser, filed a class action complaint in the United States District Court for
the Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On August 12, 2013, Plaintiff Sheet Metal Workers Local No. 25 Health & Welfare Fund, an indirect purchaser, filed a class action complaint in the
United States District Court for the Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On August 27, 2013, Plaintiff Fraternal Order of Police, Fort Lauderdale Lodge 31, Insurance Trust Fund, an indirect purchaser, filed a class action
complaint in the United States District Court for the Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On August 29, 2013, Plaintiff Heather Morgan, an indirect purchaser, filed a class action complaint in the United States District Court for the Eastern
District of Pennsylvania on behalf of itself and others similarly situated.
On August 30, 2013, Plaintiff Plumbers & Pipefitters Local 178 Health & Welfare Fund, an indirect purchaser, filed a class action complaint in the United
States District Court for the Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On September 9, 2013, Plaintiff Ahold USA, Inc., a direct purchaser, filed a class action complaint in the United States District Court for the District of
Massachusetts on behalf of itself and others similarly situated.
On September 24, 2013, Plaintiff City of Providence, Rhode Island, an indirect purchaser, filed a class action complaint in the United States District Court
for the District of Arizona on behalf of itself and others similarly situated.
On October 2, 2013, Plaintiff International Union of Operating Engineers Stationary Engineers Local 39 Health & Welfare Trust Fund, an indirect
purchaser, filed a class action complaint in the United States District Court for the District of Massachusetts on behalf of itself and others similarly situated.
On October 7, 2013, Painters District Council No. 30 Health and Welfare Fund, an indirect purchaser, filed a class action complaint in the United States
District Court for the District of Massachusetts on behalf of itself and others similarly situated.
On October 25, 2013, Plaintiff Man-U Service Contract Trust Fund, an indirect purchaser, filed a class action complaint in the United States District
Court for the Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On March 13, 2014, Plaintiff Allied Services Division Welfare Fund, an indirect purchaser, filed a class action complaint in the United States District
Court for the District of Massachusetts on behalf of itself and others similarly situated.
F-55
On March 19, 2014, Plaintiff NECA-IBEW Welfare Trust Fund, an indirect purchaser, filed a class action complaint in the United States District Court
for the District of Massachusetts on behalf of itself and others similarly situated.
On February 25, 2014, the United States Judicial Panel on Multidistrict Litigation ordered the pending actions transferred to the District of Massachusetts
for coordinated pretrial proceedings, as In Re Solodyn (Minocycline Hydrochloride) Antitrust Litigation.
On March 26, 2015, Walgreen Co., The Kruger Co., Safeway Inc., HEB Grocery Company L.P., Albertson’s LLC, direct purchasers, filed a separate
complaint in the United States District Court for the Middle District of Pennsylvania. On April 8, 2015, the Judicial Panel on Multi-District Litigation ordered the
action be transferred to the District of Massachusetts, to be coordinated or consolidated with the coordinated proceedings. The original complaint filed by the
plaintiffs asserted claims only against defendant Medicis. On October 5, 2015, the plaintiffs filed an amended complaint asserting claims against the Company and
the other generic defendants.
On April 16, 2015, Rite Aid Corporation and Rite Aid Hdqtrs. Corp, direct purchasers, filed a separate complaint in the United States District Court for
the Middle District of Pennsylvania. On May 1, 2015, the Judicial Panel on Multi-District Litigation ordered the action be transferred to the District of
Massachusetts, to be coordinated or consolidated with the coordinated proceedings. The original complaint filed by the plaintiffs asserted claims only against
defendant Medicis. On October 5, 2015, the plaintiffs filed an amended complaint asserting claims against the Company and the other generic defendants.
On January 25, 2016, CVS Pharmacy, Inc., a direct purchaser, filed a separate complaint in the United States District Court for the Middle District of
Pennsylvania. On February 11, 2016, the Judicial Panel on Multi-District Litigation ordered the action to be transferred to the District of Massachusetts to be
coordinated or consolidated with the coordinated proceedings.
The consolidated amended complaints allege that Medicis engaged in anticompetitive schemes by, among other things, filing frivolous patent litigation
lawsuits, submitting frivolous Citizen Petitions, and entering into anticompetitive settlement agreements with several generic manufacturers, including the
Company, to delay generic competition of Solodyn® and in violation of state and federal antitrust laws. Plaintiffs seek, among other things, unspecified monetary
damages and equitable relief, including disgorgement and restitution. On August 14, 2015, the Court granted in part and denied in part defendants’ motion to
dismiss the consolidated amended complaints. Discovery is ongoing. Trial is set for March 22, 2018.
Opana ER® FTC Antitrust Suit
On February 25, 2014, the Company received a Civil Investigative Demand ("CID") from the FTC concerning its investigation into the drug Opana® ER
and its generic equivalents. On March 30, 2016, the FTC filed a complaint against the Company, Endo, and others in the United States District Court for the
Eastern District of Pennsylvania, alleging that the Company and Endo violated antitrust laws when they entered into a June 2010 co-promotion and development
agreement and a June 2010 settlement agreement that resolved patent litigation in connection with the submission of the Company’s ANDA for generic original
Opana® ER. In July 2016, the defendants filed a motion to dismiss the complaint, and a motion to sever the claims regarding Opana® ER from claims with respect
to a separate settlement agreement that was challenged by the FTC. On October 20, 2016, the Court granted the motion to sever, formally terminating the suit
against the Company, with an order that the FTC re-file no later than November 3, 2016 and dismissed the motion to dismiss as moot. On October 25, 2016, the
FTC filed a notice of voluntary dismissal. On October 26, 2016, the Company and Endo filed a Declaratory Judgment complaint against the FTC in the Eastern
District of Pennsylvania seeking resolution of the legal issues that were previously subject to the companies’ motion to dismiss. On December 30, 2016, the FTC
filed a motion to dismiss the Declaratory Judgment complaint. The motion to dismiss has been fully briefed. On January 19, 2017, the FTC filed a Part 3
Administrative complaint against the Company with similar allegations regarding the Company’s June 2010 settlement agreement with Endo that resolved patent
litigation in connection with the submission of the Company’s ANDA for generic original Opana® ER. The Company filed its answer to the Administrative
Complaint on February 7, 2017 and trial is expected in September 2017.
Opana ER® Antitrust Class Actions
From June 2014 to April 2015, 14 complaints were filed as class actions on behalf of direct and end-payor (indirect) purchasers, as well as by certain
direct purchasers, against the manufacturer of the brand drug Opana ER® and the Company.
On June 4, 2014, Plaintiff Fraternal Order of Police, Miami Lodge 20, Insurance Trust Fund, an indirect purchaser, filed a class action complaint in the
United States District Court for the Eastern District of Pennsylvania on behalf of itself and others similarly situated.
F-56
On June 4, 2014, Plaintiff Rochester Drug Co-Operative, Inc., a direct purchaser, filed a class action complaint in the United States District Court for the
Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On June 6, 2014, Plaintiff Value Drug Company, a direct purchaser, filed a class action complaint in the United States District Court for the Northern
District of California on behalf of itself and others similarly situated. On June 26, 2014, this Plaintiff withdrew its complaint from the United States District Court
for the Northern District of California, and on July 16, 2014, re-filed the same complaint in the United States District Court for the Northern District of Illinois, on
behalf of itself and others similarly situated.
On June 19, 2014, Plaintiff Wisconsin Masons’ Health Care Fund, an indirect purchaser, filed a class action complaint in the United States District Court
for the Northern District of Illinois on behalf of itself and others similarly situated.
On July 17, 2014, Plaintiff Massachusetts Bricklayers, an indirect purchaser, filed a class action complaint in the United States District Court for the
Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On August 11, 2014, Plaintiff Pennsylvania Employees Benefit Trust Fund, an indirect purchaser, filed a class action complaint in the United States
District Court for the Northern District of Illinois on behalf of itself and others similarly situated.
On September 19, 2014, Plaintiff Meijer Inc., a direct purchaser, filed a class action complaint in the United States District Court for the Northern District
of Illinois on behalf of itself and others similarly situated.
On October 3, 2014, Plaintiff International Union of Operating Engineers, Local 138 Welfare Fund, an indirect purchaser, filed a class action complaint in
the United States District Court for the Northern District of Illinois on behalf of itself and others similarly situated.
On November 17, 2014, Louisiana Health Service & Indemnity Company d/b/a Blue Cross and Blue Shield of Louisiana, an indirect purchaser, filed a
class action complaint in the United States District Court for the Middle District of Louisiana on behalf of itself and others similarly situated.
On December 19, 2014, Plaintiff Kim Mahaffay, an indirect purchaser, filed a class action complaint in the Superior Court of the State of California,
Alameda County, on behalf of herself and others similarly situated. On January 27, 2015, the Defendants removed the action to the United States District Court for
the Northern District of California.
On January 12, 2015, Plaintiff Plumbers & Pipefitters Local 178 Health & Welfare Trust Fund, an indirect purchaser, filed a class action complaint in the
United States District Court for the Northern District of Illinois on behalf of itself and others similarly situated.
On December 12, 2014, the United States Judicial Panel on Multidistrict Litigation ordered the pending actions transferred to the Northern District of
Illinois for coordinated pretrial proceedings, as In Re Opana ER Antitrust Litigation.
On March 26, 2015 Walgreen Co., The Kruger Co., Safeway Inc., HEB Grocery Company L.P., Albertson’s LLC, direct purchasers, filed a separate
complaint in the United States District Court for the Northern District of Illinois.
On April 23, 2015, Rite Aid Corporation and Rite Aid Hdqtrs. Corp, direct purchasers, filed a separate complaint in the United States District Court for
the Northern District of Illinois.
In each case, the complaints allege that Endo engaged in an anticompetitive scheme by, among other things, entering into an anticompetitive settlement
agreement with the Company to delay generic competition of Opana ER® and in violation of state and federal antitrust laws. Plaintiffs seek, among other things,
unspecified monetary damages and equitable relief, including disgorgement and restitution. Consolidated amended complaints were filed on May 4, 2015 by direct
purchaser plaintiffs and end-payor (indirect) purchaser plaintiffs.
On July 3, 2015, defendants filed motions to dismiss the consolidated amended complaints, as well as the complaints of the “Opt-Out Plaintiffs”
(Walgreen Co., The Kruger Co., Safeway Inc., HEB Grocery Company L.P., Albertson’s LLC, Rite Aid Corporation and Rite Aid Hdqtrs. Corp.).
On February 1, 2016, CVS Pharmacy, Inc. filed a complaint in the United States District Court for the Northern District of Illinois. The parties agreed that
CVS Pharmacy, Inc. would be bound by the court’s ruling on the defendants’ motion to dismiss the Opt-Out Plaintiffs’ complaints.
F-57
On February 10, 2016, the court granted in part and denied in part defendants’ motion to dismiss the end-payor purchaser plaintiffs’ consolidated
amended complaint, and denied defendants’ motion to dismiss the direct purchaser plaintiffs’ consolidated amended complaint. The end-payor purchaser plaintiffs
have filed a second consolidated amended complaint and the Company has moved to dismiss certain state law claims.
On February 25, 2016, the court granted defendants’ motion to dismiss the Opt-Out Plaintiffs’ complaints, with leave to amend. The Opt-Out Plaintiffs
and CVS Pharmacy, Inc. have filed amended complaints and the Company has filed its answer.
Discovery is ongoing. No trial date has been scheduled.
Civil Investigation Demand from the Attorney General of the State of Alaska
On February 10, 2015, the Company received three CIDs from the Office of the Attorney General of the State of Alaska (“Alaska AG”) concerning its
investigations into the drugs Adderall XR ® , Effexor XR ® and Opana ® ER (each a “Product” and collectively, the “Products”) and their generic equivalents.
According to the Alaska AG, the investigation is to determine whether the Company may have violated Alaskan state law by entering into settlement agreements
with the respective brand name manufacturer for each of the foregoing Products that delayed generic entry of such Product into the marketplace. The Company
has cooperated with the Alaska AG in producing documents and information in response to the CIDs. To the knowledge of the Company, no proceedings have
been initiated against the Company at this time; however no assurance can be given as to the timing or outcome of this investigation.
United States Department of Justice Investigations
Previously on November 6, 2014, the Company disclosed that one of its sales representatives received a grand jury subpoena from the Antitrust Division
of the United States Justice Department (the “Justice Department”). In connection with this same investigation, on March 13, 2015, the Company received a grand
jury subpoena from the Justice Department requesting the production of information and documents regarding the sales, marketing, and pricing of certain generic
prescription medications. In particular, the Justice Department’s investigation currently focuses on four generic medications: digoxin tablets, terbutaline sulfate
tablets, prilocaine/lidocaine cream, and calcipotriene topical solution. The Company has been cooperating and intends to continue cooperating with the
investigation. However, no assurance can be given as to the timing or outcome of the investigation.
Attorney General of the State of Connecticut Interrogatories and Subpoena Duces Tecum
On July 14, 2014, the Company received a subpoena and interrogatories (the “Subpoena”) from the State of Connecticut Attorney General (“Connecticut
AG”) concerning its investigation into sales of the Company’s generic product, digoxin. According to the Connecticut AG, the investigation is to determine
whether anyone engaged in a contract, combination or conspiracy in restraint of trade or commerce which has the effect of (i) fixing, controlling or maintaining
prices or (ii) allocating or dividing customers or territories relating to the sale of digoxin in violation of Connecticut state antitrust law. The Company intends to
cooperate with the Connecticut AG in producing documents and information in response to the Subpoena. To the knowledge of the Company, no proceedings by
the Connecticut AG have been initiated against the Company at this time; however no assurance can be given as to the timing or outcome of this investigation.
In re Generic Digoxin and Doxycycline Class Action
From March 2016 to October 2016, 21 complaints were filed as class actions on behalf of direct and indirect purchasers against manufacturers of generic
digoxin and doxycycline and the Company alleging a conspiracy to fix, maintain and/or stabilize prices of these generic products.
On March 2, 2016, Plaintiff International Union of Operating Engineers Local 30 Benefits Fund, an indirect purchaser, filed a class action complaint in
the United States District Court for the Eastern District of Pennsylvania on behalf of itself and others similarly situated. The plaintiff filed an amended complaint
on June 9, 2016.
On March 25, 2016, Plaintiff Tulsa Firefighters Health and Welfare Trust, an indirect purchaser, filed a class action complaint in the United States District
Court for the Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On March 25, 2016, Plaintiff NECA-IBEW Welfare Trust Fund, an indirect purchaser, filed a class action complaint in the United States District Court
for the Eastern District of Pennsylvania on behalf of itself and others similarly situated.
F-58
On April 4, 2016, Plaintiff Pipe Trade Services MN, an indirect purchaser, filed a class action complaint in the United States District Court for the Eastern
District of Pennsylvania on behalf of itself and others similarly situated.
On April 25, 2016, Plaintiff Edward Carpinelli, an indirect purchaser, filed a class action complaint in the United States District Court for the Eastern
District of Pennsylvania on behalf of itself and others similarly situated.
On April 27, 2016, Plaintiff Fraternal Order of Police, Miami Lodge 20, Insurance Trust Fund, an indirect purchaser, filed a class action complaint in the
United States District Court for the Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On May 2, 2016, Plaintiff Nina Diamond, an indirect purchaser, filed a class action complaint in the United States District Court for the Eastern District
of Pennsylvania on behalf of itself and others similarly situated.
On May 5, 2016, Plaintiff UFCW Local 1500 Welfare Fund, an indirect purchaser, filed a class action complaint in the United States District Court for the
Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On May 6, 2016, Plaintiff Minnesota Laborers Health and Welfare Fund, an indirect purchaser, filed a class action complaint in the United States District
Court for the Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On May 12, 2016, Plaintiff The City of Providence, Rhode Island, an indirect purchaser, filed a class action complaint in the United States District Court
for the District of Rhode Island on behalf of itself and others similarly situated.
On May 18, 2016, Plaintiff KPH Healthcare Services, Inc. a/k/a Kinney Drugs, Inc., a direct purchaser, filed a class action complaint in the United States
District Court for the Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On May 19, 2016, Plaintiff Philadelphia Federation of Teachers Health and Welfare Fund, an indirect purchaser, filed a class action complaint in the
United States District Court for the Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On June 8, 2016, Plaintiff United Food & Commercial Workers and Employers Arizona Health and Welfare Trust, an indirect purchaser, filed a class
action complaint in the United States District Court for the Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On June 17, 2016, Plaintiff Ottis McCrary, an indirect purchaser, filed a class action complaint in the United States District Court for the Eastern District
of Pennsylvania on behalf of itself and others similarly situated.
On June 20, 2016, Plaintiff Rochester Drug Co-Operative, Inc., a direct purchaser, filed a class action complaint in the United States District Court for the
Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On June 27, 2016, Plaintiff César Castillo Inc., a direct purchaser, filed a class action complaint in the United States District Court for the Eastern District
of Pennsylvania on behalf of itself and others similarly situated.
On June 29, 2016, Plaintiff Plumbers & Pipefitters Local 33 Health and Welfare Fund, an indirect purchaser, filed a class action complaint in the United
States District Court for the Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On July 1, 2016, Plaintiff Plumbers & Pipefitters Local 178 Health and Welfare Trust Fund, an indirect purchaser, filed a class action complaint in the
United States District Court for the Eastern District of Pennsylvania on behalf of itself and others similarly situated.
On July 15, 2016, Plaintiff Ahold USA, Inc., a direct purchaser, filed a class action complaint in the United States District Court for the Eastern District of
Pennsylvania on behalf of itself and others similarly situated.
On September 7, 2016, Plaintiff United Here Health, an indirect purchaser, filed a class action complaint in the United States District Court for the
Eastern District of Pennsylvania on behalf of itself and others similarly situated.
F-59
On September 20, 2016, Plaintiff Valerie Velardi, an indirect purchaser, filed a class action complaint in the United States District Court for the Eastern
District of Pennsylvania on behalf of itself and others similarly situated.
On May 19, 2016, several indirect purchaser plaintiffs filed a motion with the Judicial Panel on Multidistrict Litigation to transfer and consolidate the
actions in the United States District Court for the Eastern District of Pennsylvania. The Judicial Panel ordered the actions consolidated in the Eastern District of
Pennsylvania and ordered that the actions be renamed “ In re Generic Digoxin and Doxycycline Antitrust Litigation ” . On January 27, 2017, plaintiffs filed two
consolidated class action complaints. With respect to doxycycline, the plaintiffs dropped their allegations against the Company. The Company’s response to the
digoxin class action complaint is due on March 28, 2017. No trial date has been scheduled.
AWP Litigation
On December 30, 2015, Plumbers’ Local Union No. 690 Health Plan and others similarly situated filed a class action against several generic drug
manufacturers, including the Company, in the Court of Common Pleas of Philadelphia County, First Judicial District of Pennsylvania, Civil Trial Division, alleging
that the Company and others violated the law, including the Pennsylvania Unfair Trade Practices and Consumer Protection law, by inflating the Average
Wholesale Price (“AWP”) of certain generic drugs. The case has since been removed to federal court in the United States District Court for the Eastern District of
Pennsylvania. By virtue of an amended complaint filed on March 29, 2016, the suit has been amended to comprise a nationwide class of third party payors that
allegedly reimbursed or purchased certain generic drugs based on AWP and to assert causes of action under the laws of other states in addition to Pennsylvania. On
May 17, 2016, this case was stayed. On January 18, 2017, the Company, along with the other defendants, filed a joint motion to dismiss the complaint.
On February 5, 2016, Delaware Valley Health Care Coalition filed a lawsuit based on substantially similar allegations in the Court of Common Pleas of
Philadelphia County, First Judicial District of Pennsylvania, Civil Trial Division that seeks declaratory judgment. On May 20, 2016, this case was stayed pending
resolution of the federal court action described above.
CID from the U.S. Attorney Office, Southern District of New York
On March 8, 2016, the Company received a CID from the U.S. Attorney Office, Southern District of New York, Civil Frauds Unit. The CID requests
information and documents relating to the Company and any pharmacy benefit manager (“PBM”) concerning Zomig®, including any contracts between the
Company and PBMs, as well as services performed by and payments to the PBMs pursuant to those contracts. The Company intends to cooperate with the U.S.
Attorney Office in response to the CID. To the knowledge of the Company, no proceedings by the U.S. Attorney Office have been initiated against the Company at
this time; however, no assurance can be given as to the timing or outcome of this investigation.
Attorney General of the State of West Virginia Subpoena
On September 7, 2016, the Company received a subpoena (the “Subpoena”) from the State of West Virginia Office of the Attorney General (“West
Virginia AG”) seeking documents and responses to interrogatories in connection with its investigation into the marketing and sales of epinephrine auto-injectors.
According to the West Virginia AG, the investigation aims to determine whether anyone engaged in a contract, combination, or conspiracy in restraint of trade of
epinephrine auto-injectors in violation of West Virginia state antitrust law. The Company intends to cooperate with the West Virginia AG in producing documents
and information in response to the Subpoena. To the knowledge of the Company, no proceedings by the West Virginia AG have been initiated against the
Company at this time, however no assurance can be given as to the timing or outcome of this investigation.
Impax Laboratories, Inc. v. Turing Pharmaceuticals AG
On May 2, 2016, the Company filed suit against Turing Pharmaceuticals AG ("Turing") in the United States District Court for the Southern District of
New York alleging breach of the terms of the contract by which Turing purchased from the Company the right to sell the drug Daraprim®, as well as the right to
sell certain Daraprim® inventory (the “Purchase Agreement”). Specifically, the Company seeks (i) a declaratory judgment that the Company may revoke Turing’s
right to sell Daraprim® under the Company’s labeler code and national drug codes; (ii) specific performance to require Turing to comply with its obligations under
the Purchase Agreement for past due reports and for reports going forward; and (iii) money damages to remedy Turing’s failure to reimburse the Company for
chargebacks and Medicaid rebate liability when due, currently in excess of $35.7 million , and for future amounts that may be due. Turing has filed its answer and
a counterclaim against the Company alleging breach of contract and breach of the duty of good faith and fair dealing. Discovery is closed. On October 14, 2016,
the Company filed a motion for summary judgment and briefing has been completed. No trial date has been set.
F-60
International Union of Operating Engineers Local 30 Benefits Fund v. Impax Laboratories, Inc. et al.
On January 13, 2017, Plaintiff International Union of Operating Engineers Local 30 Benefits Fund, an indirect purchaser, filed a class action complaint in
the United States District Court for the Eastern District of Pennsylvania on behalf of itself and others similarly situated against manufacturers of generic
lidocaine/prilocaine and the Company alleging a conspiracy to fix, maintain and/or stabilize prices of this generic drug.
Telephone Consumer Protection Act Cases
On January 31, 2017, Plaintiff Family Medicine Pharmacy LLC filed a class action complaint in the United States District Court for the Southern District
of Alabama on behalf of itself and others similarly situated against the Company alleging violation of the Telephone Consumer Protection Act, as amended by the
Junk Fax Prevention Act of 2005 (the "Telephone Consumer Protection Act").
On February 14, 2017, Plaintiff Medicine To Go Pharmacies, Inc. filed a class action complaint in the United States District Court for the District of New
Jersey on behalf of itself and others similarly situated against the Company alleging violation of the Telephone Consumer Protection Act.
23. SEGMENT INFORMATION
The Company has two reportable segments, Impax Generics and Impax Specialty Pharma. Impax Generics develops, manufactures, sells, and distributes
generic pharmaceutical products, primarily through the following sales channels: the Impax Generics sales channel for sales of generic prescription products
directly to wholesalers, large retail drug chains, and others; the Private Label Product sales channel for generic over-the-counter and prescription products sold to
unrelated third-party customers who, in turn, sell the products under their own label; the Rx Partner sales channel for generic prescription products sold through
unrelated third-party pharmaceutical entities under their own label pursuant to alliance agreements; and the OTC Partner sales channel for over-the-counter
products sold through unrelated third-party pharmaceutical entities under their own labels pursuant to alliance and supply agreements. Revenues from the “Impax
Generics” sales channel and the “Private Label” sales channel are reported under the caption “Impax Generics sales, net” in “Note 24. Supplementary Financial
Information.” Revenues from the “OTC Partner” sales channel are reported under the caption “Other Revenues” in “Note 24. Supplementary Financial
Information.”
Impax Specialty Pharma is engaged in the development, sale and distribution of proprietary brand pharmaceutical products that the Company believes
represent improvements to already-approved pharmaceutical products addressing central nervous system (“CNS”) disorders and other select specialty segments.
Impax Specialty Pharma currently has one internally developed branded pharmaceutical product, Rytary® (IPX066), an extended release oral capsule formulation
of carbidopa-levodopa for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication
and/or manganese intoxication, which was approved by the FDA on January 7, 2015 and which the Company launched in April 2015. In November 2015, the
European Commission granted marketing authorization for Numient® (IPX066) (referred to as Rytary® in the United States). The review of the Numient®
application was conducted under the centralized licensing procedure as a therapeutic innovation, and authorization is applicable in all 28 member states of the
European Union, as well as Iceland, Liechtenstein and Norway. Impax Specialty Pharma is also engaged in the sale and distribution of four other branded products
including Zomig® (zolmitriptan) products, indicated for the treatment of migraine headaches, under the terms of the AZ Agreement with AstraZeneca in the
United States and in certain U.S. territories, and Emverm® (mebendazole) 100 mg chewable tablets, indicated for the treatment of pinworm, whipworm, common
roundworm, common hookworm, and American hookworm in single or mixed infections.
Revenues from Impax-labeled branded products are reported under the caption “Impax Specialty Pharma sales, net” in “Note 24. Supplementary Financial
Information.” Finally, the Company generated revenue in Impax Specialty Pharma from research and development services provided under a development and
license agreement with another unrelated third-party pharmaceutical company (which was terminated by mutual agreement of the parties effective December 23,
2015), and reports such revenue under the caption “Other Revenues” in “Note 24. Supplementary Financial Information.” Impax Specialty Pharma also has a
number of product candidates that are in varying stages of development.
F-61
The Company’s chief operating decision maker evaluates the financial performance of the Company’s segments based upon segment income (loss) before
income taxes. Items below income (loss) from operations are not reported by segment, since they are excluded from the measure of segment profitability reviewed
by the Company’s chief operating decision maker. Additionally, general and administrative expenses, certain selling expenses, certain litigation settlements, and
non-operating income and expenses are included in “Corporate and Other.” The Company does not report balance sheet information by segment since it is not
reviewed by the Company’s chief operating decision maker. The accounting policies for the Company’s segments are the same as those described above in the
discussion of "Revenue Recognition" and in “Note 4. Summary of Significant Accounting Policies.” The Company has no inter-segment revenue.
The tables below present segment information reconciled to total Company financial results, with segment operating income or loss including gross profit
less direct research and development expenses and direct selling expenses as well as any litigation settlements, to the extent specifically identified by segment (in
thousands):
Year Ended December 31, 2016
Revenues, net
Cost of revenues
Cost of revenues impairment charges
Selling, general and administrative
Research and development
In-process research and development impairment charges
Patent litigation
(Loss) income before income taxes
Year Ended December 31, 2015
Revenues, net
Cost of revenues
Cost of revenues impairment charges
Selling, general and administrative
Research and development
In-process research and development impairment charges
Patent litigation
Income (loss) before income taxes
Year Ended December 31, 2014
Revenues, net
Cost of revenues
Cost of revenues impairment charges
Selling, general and administrative
Research and development
Patent litigation
Income (loss) before income taxes
Impax
Generics
Impax
Specialty
Pharma
$
606,320 $
218,109 $
417,316
464,319
20,508
61,980
27,765
829
69,583
24,313
61,448
18,486
25,200
6,990
Corporate
and Other
Total
Company
— $
—
— $
119,874 $
—
— $
—
824,429
486,899
488,632
201,830
80,466
52,965
7,819
(386,397) $
12,089 $
(202,017) $
(576,325)
Impax
Generics
Impax
Specialty
Pharma
Corporate
and Other
Total
Company
710,932 $
442,742
7,303
29,641
52,478
6,360
2,942
149,537 $
58,020
—
52,427
18,144
—
1,625
— $
—
—
119,219 $
—
—
—
169,466 $
19,321 $
(129,419) $
860,469
500,762
7,303
201,287
70,622
6,360
4,567
59,368
Impax
Impax
Generics
Impax
Specialty
Pharma
Corporate
and Other
Total
Company
549,082 $
257,583
2,876
17,144
40,927
5,333
46,967 $
22,937
—
43,307
37,715
472
— $
—
—
78,939 $
—
—
$
225,219 $
(57,464) $
(77,196) $
F-62
596,049
280,520
2,876
139,390
78,642
5,805
90,559
$
$
$
$
Significant Products
The Company generally consolidates net revenue by “product family,” that is, it consolidates net revenue from products containing the same active
ingredient(s) irrespective of dosage strength, delivery method or packaging size. The Company’s significant product families, as determined based on net revenue,
and their percentage of the Company’s consolidated net revenue for each of the years ended December 31, 2016, 2015 and 2014 are set forth in the tables below (in
thousands):
Segment
Product Family
2016
Impax Generics
Epinephrine Auto-Injector family (generic Adrenaclick®)
Impax Specialty Pharma
Rytary® Family
Impax Generics
Impax Generics
Impax Generics
Oxymorphone HCI ER family
Diclofenac Sodium Gel family (generic Solaraze®)
Fenofibrate family
Segment
Product Family
Impax Generics
Impax Generics
Impax Generics
Impax Generics
Impax Generics
Diclofenac Sodium Gel family (generic Solaraze®)
Amphetamine Salts ER (CII) family (generic Adderall®)
Fenofibrate family
Metaxalone family (generic Skelaxin)
Oxymorphone HCI ER family
Segment
Product Family
Impax Generics
Impax Generics
Impax Generics
Impax Generics
Impax Generics
Amphetamine Salts ER (CII) family (generic Adderall®)
Fenofibrate family
Sevelamer Carbonate family (generic Renvela®)
Oxymorphone HCI ER family
Digoxin family (generic Lanoxin)
$
$
$
91,572
73,833
72,661
69,035
64,001
2015
148,610
106,252
93,458
69,876
59,175
2014
115,411
111,550
81,976
65,323
49,702
%
%
%
11% (1)
9% (2)
9% (3)
8% (4)
8% (5)
17% (4)
12% (6)
11% (5)
8% (7)
7% (3)
19% (6)
19% (5)
14% (8)
11% (3)
8% (9)
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
(1) Epinephrine Auto-Injector (generic Adrenaclick®) product family consists of the injector product in two different strengths and is indicated in the
emergency treatment of allergic reactions (Type 1) including anaphylaxis.
(2) Rytary® product family consists of the capsules product in four different strengths and is indicated for the treatment of Parkinson’s disease, post-
encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
(3) Oxymorphone Hydrochloride Extended Release product family consists of the oxymorphone hydrochloride extended release tablet formulation of the
product in seven different strengths and is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid
treatment and for which alternative treatment options are inadequate.
(4) Diclofenac Sodium Gel (generic Solaraze®) product family consists of one product strength and is indicated for the topical treatment of actinic
keratosis.
F-63
(5) Fenofibrate product family consists of products in both capsule and tablet dosage forms in seven different strengths and is indicated as adjunctive
therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C in adult patients with primary
hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb); and also indicated as adjunctive therapy to diet for treatment of adult
patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia).
(6) Amphetamine Salts extended release capsules, CII (generic Adderall XR®) product family consists of the capsules product in six different strengths
and is indicated for the treatment of attention deficit hyperactivity disorder.
(7) Metaxalone (generic Skelaxin®) product family consists of the tablet product in two different strengths and is indicated as an adjunct to rest, physical
therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions.
(8) Sevelamar Carbonate (generic Renvela®) product family consists of the tablet product and is indicated for the control of serum phosphorous in patients
with chronic kidney disease on dialysis.
(9) Digoxin (generic Lanoxin®) product family consists of the tablet product in two different strengths and is indicated for the treatment of mild to
moderate heart failure in adults, to increase myocardial contractility in pediatric patients with heart failure and the control of ventricular response rate in
adult patients with chronic atrial fibrillation.
Foreign Operations
The Company’s wholly-owned subsidiary, Impax Laboratories (Taiwan) Inc., has constructed a facility in Taiwan which is utilized for manufacturing,
research and development, warehouse, and administrative functions, with $134.9 million and $131.6 million of net carrying value of assets, composed principally
of a building and equipment, included in the Company's consolidated balance sheets at December 31, 2016 and 2015 , respectively.
F-64
24. SUPPLEMENTARY FINANCIAL INFORMATION (Unaudited)
Selected financial information for the quarterly periods noted is as follows:
(in thousands, except share and per share amounts)
March 31
June 30
September 30
December 31
2016 Quarters Ended
Revenue:
Impax Generics sales, gross
$
611,281 $
531,226 $
651,372 $
687,462
Less:
Chargebacks
Rebates
Product returns
Other credits
Impax Generics sales, net
Rx Partner
Other Revenues
Impax Generics revenues, net
217,354
185,476
11,913
29,354
167,184
2,835
60
197,864
178,097
10,237
25,075
119,953
1,669
73
254,681
163,340
16,151
48,607
168,593
6,672
55
170,079
121,695
175,320
310,961
193,838
7,920
38,729
136,014
3,163
49
139,226
Impax Specialty Pharma sales, gross
82,073
81,254
77,841
108,149
Less:
Chargebacks
Rebates
Product returns
Other credits
Impax Specialty Pharma sales, net
Other Revenues
Impax Specialty Pharma revenues, net
Total revenues
Gross profit (loss)
Net loss
Net loss per common share:
Basic
Diluted
6,111
2,853
1,508
16,172
55,429
—
55,429
8,826
2,430
1,279
17,824
50,895
—
50,895
5,439
3,556
574
15,683
52,589
—
52,589
15,253
3,016
2,802
27,854
59,224
(28)
59,196
225,508
172,590
227,909
198,422
102,590
72,984
(165,426)
(161,250)
$
(10,408) $
(2,701) $
(179,337) $
(279,585)
$
$
(0.15) $
(0.15) $
(0.04) $
(0.04) $
(2.51) $
(2.51) $
(3.91)
(3.91)
Weighted-average common shares outstanding:
Basic
Diluted
70,665,394
71,100,123
71,331,247
70,665,394
71,100,123
71,331,247
71,487,071
71,487,071
Quarterly computations of net (loss) income per share amounts are made independently for each quarterly reporting period, and the sum of the per share
amounts for the quarterly reporting periods may not equal the per share amounts for the year-to-date reporting period.
F-65
(in thousands, except share and per share amounts)
March 31
June 30
September 30
December 31
2015 Quarters Ended
Revenue:
Impax Generics sales, gross
$
355,321 $
572,079 $
565,261 $
705,574
Less:
Chargebacks
Rebates
Product returns
Other credits
Impax Generics sales, net
Rx Partner
Other Revenues
Impax Generics revenues, net
126,607
83,130
6,427
13,198
125,959
2,239
543
228,977
140,340
7,528
23,961
171,273
2,579
827
212,588
141,646
6,276
26,295
178,456
1,957
253
128,741
174,679
180,666
239,920
200,721
8,888
31,889
224,156
2,532
158
226,846
Impax Specialty Pharma sales, gross
29,219
65,269
69,286
86,274
Less:
Chargebacks
Rebates
Product returns
Other credits
Impax Specialty Pharma sales, net
Other Revenues
Impax Specialty Pharma revenues, net
Total revenues
Gross profit
Net (loss) income
Net (loss) income per common share:
Basic
Diluted
Weighted-average common shares outstanding:
Basic
Diluted
5,561
1,418
2,620
5,492
14,128
227
14,355
4,452
1,318
6,763
13,461
39,275
228
39,503
5,893
1,078
2,824
19,285
40,206
227
40,433
9,159
1,991
2,641
20,866
51,617
3,629
55,246
143,096
214,182
221,099
282,092
59,234
84,851
93,549
114,770
(6,333) $
(1,852) $
35,755 $
11,427
(0.09) $
(0.09) $
(0.03) $
(0.03) $
0.51 $
0.49 $
0.16
0.16
$
$
$
68,967,875
69,338,789
69,820,348
68,967,875
69,338,789
72,777,746
70,416,757
72,041,760
Quarterly computations of net (loss) income per share amounts are made independently for each quarterly reporting period, and the sum of the per share
amounts for the quarterly reporting periods may not equal the per share amounts for the year-to-date reporting period.
F-66
25. SUBSEQUENT EVENTS
Voluntary Prepayment of $50.0 Million of Principal - RBC Term Loan Facility
On February 28, 2017, the Company made a voluntary prepayment in the amount of $50.3 million under its Term Loan Facility with RBC as
administrative agent and the lender parties thereto, as described in "Note 13. Debt," representing $50.0 million of principal amount and $0.3 million of accrued
interest thereon. As a result of the payment, the outstanding principal amount on the Term Loan Facility decreased to $345.0 million .
F-67
SCHEDULE II, VALUATION AND QUALIFYING ACCOUNTS
(In thousands)
Column A
Description
For the Year Ended December 31, 2014:
Reserve for bad debts
For the Year Ended December 31, 2015:
Reserve for bad debts
For the Year Ended December 31, 2016:
$
$
Column B
Balance at
Beginning of
Period
Column C
Column D
Charge to
Costs and
Expenses
Charge to
Other
Accounts
Deductions
Column E
Balance at
End of
Period
539
—
—
(24)
$
515
515
5,122
9,550
*
— $
15,187
Reserve for bad debts
$
15,187
41,213
—
(1,664)
$
54,736
* Represents reserve for bad debts acquired.
S-1
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized.
SIGNATURES
IMPAX LABORATORIES, INC.
By:
/s/ J. Kevin Buchi
Name:
J. Kevin Buchi
Title:
Interim President and
Chief Executive Officer
Date: March 1, 2017
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.
Signature
/s/ J. Kevin Buchi
J. Kevin Buchi
/s/ Bryan M. Reasons
Bryan M. Reasons
/s/ Robert L. Burr
Robert L. Burr
/s/ Leslie Z. Benet, Ph.D.
Leslie Z. Benet, Ph.D.
/s/ Richard Bierly
Richard Bierly
/s/ Allen Chao, Ph.D.
Allen Chao, Ph.D.
/s/ Mary K. Pendergast
Mary K. Pendergast
/s/ Peter R. Terreri
Peter R. Terreri
/s/ Janet S. Vergis
Janet S. Vergis
Title
Interim President, Chief Executive Officer
(Principal Executive Officer) and Director
Senior Vice President, Finance and
Chief Financial Officer
(Principal Financial Officer and
Principal Accounting Officer)
Date
March 1, 2017
March 1, 2017
Chairman of the Board
March 1, 2017
Director
Director
Director
Director
Director
Director
March 1, 2017
March 1, 2017
March 1, 2017
March 1, 2017
March 1, 2017
March 1, 2017
Exhibit No.
Description of Document
EXHIBIT INDEX
2.1
3.1.1
3.1.2
3.1.3
3.2.1
3.2.2
3.2.3
3.2.4
3.2.5
3.2.6
3.2.7
3.2.8
4.1
4.2
4.3
10.1
10.2
10.3
10.4
10.5
10.6
10.7.1
10.7.2
Stock Purchase Agreement, dated as of October 8, 2014, by and among the Company, Tower Holdings, Inc. (“Tower”), Lineage Therapeutics
Inc. (“Lineage”), Roundtable Healthcare Partners II, L.P., Roundtable Healthcare Investors II, L.P., the other stockholders of Tower and
Lineage, the holders of options to purchase shares of Tower common stock and options to purchase shares of Lineage common stock, the
holders of warrants to acquire shares of Tower common stock and warrants to acquire shares of Lineage common stock and, solely with respect
to Section 8.3, Roundtable Healthcare Management II, LLC. †(1)
Certificate of Amendment of the Restated Certificate of Incorporation of the Company dated as of December 9, 2015.(2)
Restated Certificate of Incorporation of the Company dated as of August 30, 2004.(3)
Certificate of Designation of Series A Junior Participating Preferred Stock, as filed with the Secretary of State of Delaware on January 21, 2009.
(4)
Amendment No. 7 to Amended and Restated Bylaws of the Company, effective as of December 19, 2016.
Amendment No. 6 to Amended and Restated Bylaws of the Company, effective as of November 23, 2016.
Amendment No. 5 to Amended and Restated Bylaws of the Company, effective as of August 19, 2016.
Amendment No. 4 to Amended and Restated Bylaws of the Company, effective as of May 17, 2016.
Amendment No. 3 to Amended and Restated Bylaws of the Company, effective as of October 7, 2015.
Amendment No. 2 to Amended and Restated Bylaws of the Company, effective as of July 7, 2015.
Amendment No. 1 to Amended and Restated Bylaws of the Company, effective as of March 24, 2015.
Amended and Restated Bylaws of the Company, effective as of May 14, 2014.
Specimen of Common Stock Certificate.(5)
Preferred Stock Rights Agreement, dated as of January 20, 2009, by and between the Company and StockTrans, Inc., as Rights Agent.(4)
Indenture, dated as of June 30, 2015, between the Company, and Wilmington Trust, National Association, as trustee.(6)
Letter Agreement, dated as of June 25, 2015, between RBC Capital Markets LLC and the Company regarding the Base Warrants.(6)
Letter Agreement, dated as of June 25, 2015 between RBC Capital Markets LLC and the Company regarding the Base Call Option Transaction.
(6)
Letter Agreement, dated as of June 26, 2015, between RBC Capital Markets LLC and the Company regarding the Additional Warrants.(6)
Letter Agreement, dated as of June 26, 2015, between RBC Capital Markets LLC and the Company regarding the Additional Call Option
Transaction.(6)
Credit Agreement, dated as of August 4, 2015, by and among the Company, the lenders party thereto from time to time and Royal Bank of
Canada, as administrative agent and collateral agent.(7)
Restatement Agreement, dated as of August 3, 2016, by and the Company, the guarantors party thereto, Royal Bank of Canada, as
administrative agent, and the lenders party thereto.(8)
First Amendment, dated as of May 31, 2016, to the Distribution, License, Development and Supply Agreement by and between AstraZeneca UK
Limited and the Company dated as of January 31, 2012.**(8)
Distribution, License, Development and Supply Agreement, dated as of January 31, 2012, between the Company and AstraZeneca UK
Limited.**(9)
10.8.1
10.8.2
10.9.1
10.9.2
10.10.1
10.10.2
10.11.1
10.11.2
10.12
10.13.1
10.13.2
10.14
10.15.1
10.15.2
10.15.3
10.16.1
10.16.2
10.17.1
10.17.2
10.18.1
10.18.2
10.19
10.20.1
10.20.2
Asset Purchase Agreement, dated as of June 20, 2016, between Teva Pharmaceutical Industries Ltd. and the Company. †**(10)
Amendment No. 1 dated as of June 30, 2016 to the Asset Purchase Agreement between Teva Pharmaceutical Industries Ltd. and the Company
dated as of June 20, 2016.(8)
Asset Purchase Agreement, dated as of June 20, 2016, by and among Actavis Elizabeth LLC, Actavis Group PTC Ehf., Actavis Holdco US, Inc.,
Actavis LLC, Actavis Mid Atlantic LLC, Actavis Pharma, Inc., Actavis South Atlantic LLC, Andrx LLC, Breath Ltd., The Rugby Group, Inc.,
Watson Laboratories, Inc. and the Company. †**(10)
Amendment No. 1 dated as of June 30, 2016 to the Asset Purchase Agreement by and among Actavis Elizabeth LLC, Actavis Group PTC Ehf.,
Actavis Holdco US, Inc., Actavis LLC, Actavis Mid Atlantic LLC, Actavis Pharma, Inc., Actavis South Atlantic LLC, Andrx LLC, Breath Ltd.,
The Rugby Group, Inc., Watson Laboratories, Inc. and the Company dated as of June 20, 2016. **(10)
Supply Agreement, dated as of June 20, 2016, between Teva Pharmaceutical Industries Ltd. and the Company.**(10)
Amendment No. 1, dated as of June 30, 2016, to the Supply Agreement between Teva Pharmaceutical Industries Ltd. and the Company dated as
of June 20, 2016.**(10)
Supply Agreement, dated as of June 20, 2016, by and among Actavis Elizabeth LLC, Actavis Group PTC Ehf., Actavis Holdco US, Inc.,
Actavis LLC, Actavis Mid Atlantic LLC, Actavis Pharma, Inc., Actavis South Atlantic LLC, Andrx LLC, Breath Ltd., The Rugby Group, Inc.,
Watson Laboratories, Inc. and the Company.**(10)
Amendment No. 1, dated as of June 30, 2016, to the Supply Agreement by and among Actavis Elizabeth LLC, Actavis Group PTC Ehf., Actavis
Holdco US, Inc., Actavis LLC, Actavis Mid Atlantic LLC, Actavis Pharma, Inc., Actavis South Atlantic LLC, Andrx LLC, Breath Ltd., The
Rugby Group, Inc., Watson Laboratories, Inc. and the Company dated as of June 20, 2016.**(10)
Amended and Restated License and Distribution Agreement, dated as of February 7, 2013, between the Company and Shire LLC.**(11)
Impax Laboratories, Inc. 1999 Equity Incentive Plan.*(12)
Form of Stock Option Grant under the Impax Laboratories, Inc. 1999 Equity Incentive Plan.*(12)
Impax Laboratories, Inc. 2001 Non-Qualified Employee Stock Purchase Plan.*(5)
Impax Laboratories, Inc. Third Amended and Restated 2002 Equity Incentive Plan.*(13)
Form of Stock Option Agreement under the Impax Laboratories, Inc. Third Amended and Restated 2002 Equity Incentive Plan.*(14)
Form of Restricted Stock (Stock Bonus) Agreement under the Impax Laboratories, Inc. Third Amended and Restated 2002 Equity Incentive
Plan.*(15)
Impax Laboratories, Inc. Executive Non-Qualified Deferred Compensation Plan, amended and restated effective January 1, 2008.*(16)
Amendment to Impax Laboratories, Inc. Executive Non-Qualified Deferred Compensation Plan, effective as of January 1, 2009.* (16)
Employment Agreement, dated as of January 1, 2010, between the Company and Charles V. Hildenbrand.*(17)
Confidential Separation and Release Agreement, dated as of July 5, 2011, between the Company and Charles V. Hildenbrand.*(18)
Employment Agreement, dated as of January 1, 2010, between the Company and Arthur A. Koch, Jr.*(17)
General Release and Waiver, effective as of July 17, 2012, between the Company and Arthur A. Koch, Jr.* (19)
Letter Agreement between J. Kevin Buchi, dated as of December 19, 2016, between the Company and J. Kevin Buchi.*
Employment Agreement, dated as of April 21, 2014, by and between the Company and G. Frederick Wilkinson.*(20)
General Release and Waiver, dated as of December 19, 2016, by and between the Company and G. Frederick Wilkinson.*
10.21.1
10.21.2
10.22
10.23.1
10.23.2
10.23.3
10.24.1
10.24.2
10.25.1
10.25.2
Employment Agreement, dated as of January 1, 2010, between the Company and Michael J. Nestor.*(17)
Amendment, dated as of April 1, 2014, to the Employment Agreement, dated as of January 1, 2014, between the Company and Michael Nestor.*
(21)
Employment Agreement, dated as of July 14, 2016, between the Company and Douglas S. Boothe.*(8)
Offer of Employment Letter, dated as of March 17, 2011, between the Company and Mark A. Schlossberg.*(22)
Employment Agreement, dated as of May 2, 2011, between the Company and Mark A. Schlossberg.*(22)
Amendment, dated as of April 1, 2014, to the Employment Agreement, dated as of May 2, 2011, between the Company and Mark A.
Schlossberg.*(21)
Employment Agreement, dated as of December 12, 2012, between the Company and Bryan M. Reasons.*(23)
Amendment, dated as of April 1, 2014, to the Employment Agreement, dated as of December 12, 2012 between the Company and Bryan M.
Reasons.*(21)
Employment Agreement, dated as of November 28, 2011, by and between the Company and Jeffrey Nornhold.*(24)
Amendment, dated as of April 1, 2014, to the Employment Agreement, dated as of November 28, 2011, by and between the Company and
Jeffrey Nornhold.*(24)
10.25.3
Letter Agreement, dated as of April 1, 2014, between the Company and Jeffrey Nornhold.*(24)
11.1
21.1
23.1
31.1
31.2
32.1
32.2
Statement re computation of per share earnings (incorporated by reference to Note 15 to the Notes to Consolidated Financial Statements in this
Annual Report on Form 10-K).
Subsidiaries of the registrant.
Consent of Independent Registered Public Accounting Firm.
Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002.
Certification of the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002.
101
The following materials from the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, formatted in XBRL
(eXtensible Business Reporting Language): (i) Consolidated Balance Sheets as of December 31, 2016 and 2015, (ii) Consolidated Statements of
Operations for each of the three years in the period ended December 31, 2016, (iii) Consolidated Statements of Comprehensive (Loss) Income
for each of the three years in the period ended December 31, 2016, (iv) Consolidated Statements of Changes in Stockholders’ Equity for each of
the three years in the period ended December 31, 2016, (v) Consolidated Statements of Cash Flows for each of the three years in the period
ended December 31, 2016 and (vi) Notes to Consolidated Financial Statements for each of the three years in the period ended December 31,
2016.
____________________________________
*
**
†
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
(18)
(19)
(20)
(21)
(22)
(23)
(24)
Management contract, compensatory plan or arrangement.
Confidential treatment granted for certain portions of this exhibit pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), which portions are omitted and filed separately with the SEC.
Schedules omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company agrees to furnish a supplemental copy of any omitted schedule to the
SEC upon request.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on October 10, 2014.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on December 9, 2015.
Incorporated by reference to Amendment No. 5 to the Company’s Registration Statement on Form 10 filed on December 23, 2008.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on January 22, 2009.
Incorporated by reference to the Company’s Registration Statement on Form 10 filed on October 10, 2008.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on June 30, 2015.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on August 5, 2015.
Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016.
Incorporated by reference to the Company’s Current Report on Form 8-K/A filed on April 2, 2012.
Incorporated by reference to the Company’s Quarterly Report on Form 10-Q/A for the quarter ended June 30, 2016 filed on January 6, 2017.
Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2013.
Incorporated by reference to the Company’s Annual Report on Form 10-K for the year ended December 31, 2008.
Incorporated by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A (File No. 001-34263) filed on April 14, 2016.
Incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-8 (File No. 333-189360) filed on June 14, 2013.
Incorporated by reference to Exhibit 4.6 to the Company’s Registration Statement on Form S-8 (File No. 333-189360) filed on June 14, 2013.
Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2010.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on January 14, 2010.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on July 11, 2011.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on July 18, 2012.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on April 24, 2014.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on April 2, 2014.
Incorporated by reference to the Company’s Annual Report on Form 10-K for the year ended December 31, 2011.
Incorporated by reference to the Company’s Current Report on Form 8-K filed on December 13, 2012.
Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2014.
AMENDMENT NO. 7 TO
AMENDED AND RESTATED BYLAWS OF
IMPAX LABORATORIES, INC., AS AMENDED
Exhibit 3.2.1
The Amended and Restated Bylaws of Impax Laboratories, Inc., as amended (the “Bylaws”) are hereby amended as
follows:
1. Section 14 of Article III shall be amended and restated in its entirety to read as follows:
“SECTION 14. NUMBER. The authorized number of directors shall be no less than one nor more than eight. Within
the foregoing limits, the number of directors shall be fixed from time to time by resolution adopted by the Board. (Del Code Ann.,
tit. 8, §§ 141(b)).”
Except as expressly modified hereby, the Bylaws and all the provisions contained therein shall remain in full force and
2.
effect.
This Amendment No. 7 to the Bylaws was adopted by the Board of Directors of Impax Laboratories,
Inc., effective December 19, 2016.
/s/ Mark A. Schlossberg
Name: Mark A. Schlossberg
Title: Senior VP, General Counsel and Corporate Secretary
AMENDMENT NO. 6 TO
AMENDED AND RESTATED BYLAWS OF
IMPAX LABORATORIES, INC., AS AMENDED
Exhibit 3.2.2
The Amended and Restated Bylaws of Impax Laboratories, Inc., as amended (the “Bylaws”) are hereby amended as
follows:
1. Section 14 of Article III shall be amended and restated in its entirety to read as follows:
“SECTION 14. NUMBER. The authorized number of directors shall be no less than one nor more than nine. Within
the foregoing limits, the number of directors shall be fixed from time to time by resolution adopted by the Board. (Del Code Ann.,
tit. 8, §§ 141(b)).”
Except as expressly modified hereby, the Bylaws and all the provisions contained therein shall remain in full force and
2.
effect.
This Amendment No. 6 to the Bylaws was adopted by the Board of Directors of Impax Laboratories,
Inc., effective November 23, 2016.
/s/ Mark A. Schlossberg
Name: Mark A. Schlossberg
Title: Senior VP, General Counsel and Corporate Secretary
AMENDMENT NO. 5 TO
AMENDED AND RESTATED BYLAWS OF
IMPAX LABORATORIES, INC., AS AMENDED
Exhibit 3.2.3
The Amended and Restated Bylaws of Impax Laboratories, Inc., as amended (the “Bylaws”) are hereby amended as
follows:
1. Section 14 of Article III shall be amended and restated in its entirety to read as follows:
“SECTION 14. NUMBER. The authorized number of directors shall be no less than one nor more than eight. Within
the foregoing limits, the number of directors shall be fixed from time to time by resolution adopted by the Board. (Del Code Ann.,
tit. 8, §§ 141(b)).”
Except as expressly modified hereby, the Bylaws and all the provisions contained therein shall remain in full force and
2.
effect.
This Amendment No. 5 to the Bylaws was adopted by the Board of Directors of Impax Laboratories,
Inc., effective August 19, 2016.
/s/ Mark A. Schlossberg
Name: Mark A. Schlossberg
Title: Senior VP, General Counsel and Corporate Secretary
AMENDMENT NO. 4 TO
AMENDED AND RESTATED BYLAWS OF
IMPAX LABORATORIES, INC., AS AMENDED
Exhibit 3.2.4
The Amended and Restated Bylaws of Impax Laboratories, Inc., as amended (the “Bylaws”) are hereby amended as
follows:
1. Section 14 of Article III shall be amended and restated in its entirety to read as follows:
“SECTION 14. NUMBER. The authorized number of directors shall be no less than one nor more than seven. Within
the foregoing limits, the number of directors shall be fixed from time to time by resolution adopted by the Board. (Del Code Ann.,
tit. 8, §§ 141(b)).”
Except as expressly modified hereby, the Bylaws and all the provisions contained therein shall remain in full force and
2.
effect.
This Amendment No. 4 to the Bylaws was adopted by the Board of Directors of Impax Laboratories,
Inc., effective May 17, 2016.
/s/ Mark A. Schlossberg
Name: Mark A. Schlossberg
Title: Senior VP, General Counsel and Corporate Secretary
AMENDMENT NO. 3 TO
AMENDED AND RESTATED BYLAWS OF
IMPAX LABORATORIES, INC., AS AMENDED
Exhibit 3.2.5
The Amended and Restated Bylaws of Impax Laboratories, Inc., as amended (the “Bylaws”) are hereby amended as
follows:
1. Section 14 of Article III shall be amended and restated in its entirety to read as follows:
“SECTION 14. NUMBER. The authorized number of directors shall be no less than one nor more than nine. Within
the foregoing limits, the number of directors shall be fixed from time to time by resolution adopted by the Board. (Del Code Ann.,
tit. 8, §§ 141(b)).”
Except as expressly modified hereby, the Bylaws and all the provisions contained therein shall remain in full force and
2.
effect.
This Amendment No. 3 to the Bylaws was adopted by the Board of Directors of Impax Laboratories,
Inc., effective October 7, 2015
/s/ Mark A. Schlossberg
Name: Mark A. Schlossberg
Title: Senior VP, General Counsel and Corporate Secretary
AMENDMENT NO. 2 TO
AMENDED AND RESTATED BYLAWS OF
IMPAX LABORATORIES, INC., AS AMENDED
Exhibit 3.2.6
The Amended and Restated Bylaws of Impax Laboratories, Inc., as amended (the “Bylaws”) are hereby amended as
follows:
1. Section 14 of Article III shall be amended and restated in its entirety to read as follows:
“SECTION 14. NUMBER. The authorized number of directors shall be no less than one nor more than eight. Within
the foregoing limits, the number of directors shall be fixed from time to time by resolution adopted by the Board. (Del Code Ann.,
tit. 8, §§ 141(b)).”
Except as expressly modified hereby, the Bylaws and all the provisions contained therein shall remain in full force and
2.
effect.
This Amendment No. 2 to the Bylaws was adopted by the Board of Directors of Impax Laboratories,
Inc., effective July 7, 2015.
/s/ Mark A. Schlossberg
Name: Mark A. Schlossberg
Title: Senior VP, General Counsel and Corporate Secretary
AMENDED AND RESTATED BYLAWS OF IMPAX LABORATORIES, INC.
AMENDMENT NO. 1 TO
Exhibit 3.2.7
The Amended and Restated Bylaws of Impax Laboratories, Inc. (the “Bylaws”) are hereby amended as follows:
1. Section 5 of Article II shall be amended and restated in its entirety to read as follows:
“SECTION 5. QUORUM. At all meetings of stockholders, except where otherwise provided by statute, by the
Certificate, or by these Bylaws, the presence, in person, by remote communication, if applicable, or represented by proxy duly
authorized, of the holders of a majority of the issued and outstanding shares of stock entitled to vote thereat shall constitute a quorum
for the transaction of business. Where a separate vote by a class, classes or series is required, except where otherwise provided by
the statute, the Certificate or these Bylaws, a majority of the outstanding shares of such class, classes or series, present in person, by
remote communication, if applicable, or represented by proxy duly authorized, shall constitute a quorum entitled to take action with
respect to that vote on that matter. In the absence of a quorum, any meeting of stockholders may be adjourned, from time to time,
either by the chairman of the meeting or by vote of the holders of a majority of the shares represented thereat, but no other business
shall be transacted at such meeting. The stockholders present at a duly called or convened meeting, at which a quorum is present,
may continue to transact business until adjournment, notwithstanding the withdrawal of enough stockholders to leave less than a
quorum.”
2. Section 6 of Article II shall be amended and restated in its entirety to read as follows:
“SECTION 6. VOTING. Unless otherwise provided in the Certificate, each stockholder shall be entitled to one vote
for each share of capital stock held by such stockholder. The Board, in its discretion, or the officer of the Corporation presiding at a
meeting of stockholders, in his discretion, may require that any votes cast at a meeting of stockholders shall be cast by written ballot.
Except as otherwise provided by statute, by the Certificate or these
Bylaws, in all matters other than the election of directors, the affirmative vote of the majority of shares present in person, by remote
communication, if applicable, or represented by proxy at the
-2-
meeting and entitled to vote generally on the subject matter shall be the act of the stockholders. Except as otherwise provided by the
Certificate, each director shall be elected by the affirmative vote of the majority of the votes cast with respect to such director
(meaning the number of shares voted “for” a nominee must exceed the number of shares voted “against” such nominee) at any
meeting for the election of directors at which a quorum is present; provided that each director shall be elected by a plurality of the
votes cast (instead of by votes cast for or against a nominee) at any meeting at which a quorum in present for which the Board
determines that the number of nominees exceeds the number of directors to be elected at such election and such determination has
not been rescinded by the Board on or prior to the tenth day preceding the date the Corporation first mails its notice of meeting for
such meeting to the stockholders (a “Contested Election”). In an election other than a Contested Election, stockholders will be given
the choice to cast votes “for” or “against” the election of directors or to “abstain” from such vote (with abstentions and broker non-
votes not counted as a vote cast “for” or “against” the election of such candidate), and stockholders shall not have the ability to cast
any other vote with respect to such election of directors. In a Contested Election, stockholders will be given the choice to cast “for”
or “withhold” votes for the election of directors and shall not have the ability to cast any other vote with respect to such election of
directors.”
Except as expressly modified hereby, the Bylaws and all the provisions contained therein shall remain in full force and
3.
effect.
This Amendment No. 1 to the Bylaws was adopted by the Board of Directors of Impax Laboratories,
Inc., effective March 24, 2015.
/s/ Mark A. Schlossberg
Name: Mark A. Schlossberg
Title: Senior VP, General Counsel and Corporate Secretary
-3-
Exhibit 3.2.8
BYLAWS
OF
IMPAX LABORATORIES, INC.
(a Delaware corporation)
(Amended and Restated as of May 14, 2014)
ARTICLE I
OFFICES
SECTION 1. OFFICES. The Corporation shall maintain its registered office in the State of Delaware at 32 Loockerman Square, Suite L-100, in the County
of Kent, and its resident agent at such address is the Prentice-Hall Corporation System, Inc. The Corporation may also have and maintain offices in such other
places in the United States or elsewhere as the Board of Directors of the Corporation (the “ Board ”) may, from time to time, determine or as the business of the
Corporation may require. (Del Code Ann., tit. 8, §131).
ARTICLE II
MEETINGS OF STOCKHOLDERS
SECTION 2. ANNUAL MEETINGS. Annual meetings of stockholders for the election of directors and for such other business as may properly come before
such meeting in accordance with all applicable requirements of these Bylaws and the General Corporation Law of the State of Delaware, as amended from time to
time (the “ DGCL ”), shall be held at such place, either within or without the State of Delaware, and at such time and date as shall from time to time be determined
by the Board. Any previously scheduled annual meeting of the stockholders may be postponed by action of the Board taken prior to the time previously scheduled
for such annual meeting of stockholders. The Board may, in its sole discretion, determine that the meeting shall not be held at any place, but may instead be held
solely by means of remote communication as provided under the DGCL. (Del Code Ann., tit. 8, §211(a), (b)).
SECTION 3. SPECIAL MEETINGS. Special meetings of stockholders, unless otherwise prescribed by the DGCL or the Restated Certificate of
Incorporation of the Corporation (the “ Certificate ”), may be called by the Chairman of the Board, the Chief Executive Officer or by resolution adopted by a
majority of the total number of authorized directors (whether or not there exists any vacancies in previously authorized directorships at the time any such resolution
is presented to the Board for adoption). Only such business as is specified in the Corporation’s notice of any such special meeting of stockholders shall come
before, and be conducted at, such meeting. A special meeting shall be held at such place, on such date and at such time as shall be fixed by the Board. (Del Code
Ann., tit. 8, §211(d)).
SECTION 4. NOTICE OF MEETINGS. Whenever stockholders are required or permitted to take any action at a meeting, a written notice of the meeting
shall be given not less than ten (10) days nor more than sixty (60) days before the date of any such meeting to each stockholder entitled to vote at such meeting,
such notice to specify the place, if any, date and hour, in the case of special meetings, the purpose or purposes of the meeting and the means of remote
communications, if any, by which stockholders and proxy holders may be deemed to be present in person and vote at any such meeting. If mailed, notice is given
when deposited in the United States mail, postage prepaid, directed to the stockholder at such stockholder’s address as it appears on the records of the corporation.
Notice of the time, place, if any, and purpose of any meeting of stockholders may be waived in writing, signed by the person entitled to notice thereof or by
electronic transmission by such person, either before or after such meeting, and will be waived by any stockholder by his attendance thereat in person, by remote
communication, if applicable, or by proxy, except when the stockholder attends a meeting for the express purpose of objecting, at the beginning of the meeting, to
the transaction of any business because the meeting is not lawfully called or convened. Any stockholder so waiving notice of such meeting shall be bound by the
proceedings of any such meeting in all respects as if due notice thereof had been given. (Del Code Ann., tit. 8, §§229, 232).
SECTION 5. QUORUM. At all meetings of stockholders, except where otherwise provided by statute, by the Certificate, or by these Bylaws, the presence,
in person, by remote communication, if applicable, or by proxy duly authorized, of the holders of a majority of the issued and outstanding shares of stock entitled
to vote thereat shall constitute a quorum for the transaction of business. In the absence of a quorum, any meeting of stockholders may be adjourned, from time to
time, either by the chairman of the meeting or by vote of the holders of a majority of the shares represented thereat, but no other business shall be transacted at such
meeting. The stockholders present at a duly called or convened meeting, at which a quorum is present, may continue to transact business until adjournment,
notwithstanding the withdrawal of enough stockholders to leave less than a quorum. (Del Code Ann., tit. 8, §216).
SECTION 6. VOTING. Unless otherwise provided in the Certificate, each stockholder shall be entitled to one vote for each share of capital stock held by
such stockholder. The Board, in its discretion, or the officer of the Corporation presiding at a meeting of stockholders, in his discretion, may require that any votes
cast at a meeting of stockholders shall be cast by written ballot. Except as otherwise provided by statute, by applicable stock exchange, rules, by the Certificate or
these Bylaws, in all matters other than the election of directors, the affirmative vote of the majority of shares present in person, by remote communication, if
applicable, or represented by proxy at the meeting and entitled to vote generally on the subject matter shall be the act of the stockholders. Except as otherwise
provided by statute, the Certificate or these Bylaws, directors shall be elected by a plurality of the votes of the shares present in person, by remote communication,
if applicable, or represented by proxy at the meeting and entitled to vote generally on the election of directors. Where a separate vote by a class, classes or series is
required, except where otherwise provided by the statute, the Certificate or these Bylaws, a majority of the outstanding shares of such class, classes or series,
present in person, by remote communication, if applicable, or represented by proxy duly authorized, shall constitute a quorum entitled to take action with respect to
that vote on that matter. Except where otherwise provided by statute, the Certificate or these Bylaws, the affirmative vote of the majority (plurality, in the case of
the election of directors) of shares of such class or classes or series present in person, by remote communication, if applicable, or represented by proxy at the
meeting shall be the act of such class, classes or series. (Del Code Ann., tit. 8, §§212, 216).
SECTION 7. INSPECTORS. The Board may, in advance of any meeting of stockholders, appoint one or more inspectors to act at such meeting or any
adjournment thereof. If any of the inspectors so appointed shall fail to appear or act, the chairman of the meeting may, or if inspectors shall not have been
appointed, the chairman of the meeting shall, appoint one or more inspectors. Each inspector, before entering upon the discharge of his duties, shall take and sign
an oath faithfully to execute the duties of inspector at such meeting with strict impartiality and according to the best of his ability. The inspectors shall (i) ascertain
the number of shares of capital stock of the Corporation outstanding and the voting power of each, (ii) ascertain the number of shares represented at the meeting,
(iii) ascertain the existence of a quorum, (iv) ascertain the validity and effect of proxies, (v) count and tabulate all votes, ballots or consents, (vi) determine and
retain for a reasonable period a record of the disposition of all challenges made to any determination made by the inspectors, (vii) certify the determination of the
number of shares represented at the meeting and their count of all votes and ballots, and (viii) do such other acts as are proper to conduct the election or vote with
fairness to all stockholders. On request of the chairman of the meeting, the inspectors shall make a report in writing of any challenge, request or matter determined
by them and shall execute a certificate of any fact found by them. No director or candidate for the office of director shall act as an inspector of an election of
directors. The inspectors may appoint or retain other persons or entities to assist the inspectors in the performance of the duties of the inspectors. In determining the
validity and counting of all proxies and ballots, the inspectors shall act in accordance with applicable law. (Del. Code Ann., tit. 8, § 231).
SECTION 8. CONDUCT OF MEETINGS. The Chairman of the Board shall preside at all stockholders’ meetings. In the absence of the Chairman of the
Board, the Chief Executive Officer shall preside or, in his or her absence, any officer designated by the Board shall preside. The Secretary, or, in the Secretary’s
absence, an Assistant Secretary, or in the absence of both the Secretary and Assistant Secretaries, a person appointed by the chairman of the meeting shall serve as
secretary of the meeting. In the event that the Secretary presides at a meeting of the stockholders, an Assistant Secretary shall record the minutes of the meeting. To
the maximum extent permitted by law, the Board of the Corporation shall be entitled to make such rules or regulations for the conduct of meetings of stockholders
as it shall deem necessary, appropriate or convenient. Subject to such rules and regulations of the Board, if any, the chairman of the meeting shall have the right
and authority to prescribe such rules, regulations and procedures and take such action as, in the discretion of such chairman, are deemed necessary, appropriate or
convenient for the proper conduct of the meeting. Such rules, regulations and procedures, whether
adopted by the Board or prescribed by the chairman of the meeting, may include, without limitation, the following: (i) establishing an agenda for the meeting and
the order for the consideration of the items of business on such agenda; (ii) restricting admission to the time set for the commencement of the meeting; (iii) limiting
attendance at the meeting to stockholders of record of the Corporation entitled to vote at the meeting, their duly authorized proxies or other such persons as the
chairman of the meeting may determine; (iv) limiting participation at the meeting on any matter to stockholders of record of the Corporation entitled to vote on
such matter, their duly authorized proxies or other such persons as the chairman of the meeting may determine to recognize and, as a condition to recognizing any
such participant, requiring such participant to provide the chairman of the meeting with evidence of his or her name and affiliation, whether he or she is a
stockholder or a proxy for a stockholder, and the class and series and number of shares of each class and series of capital stock of the Corporation which are owned
beneficially and/or of record by such stockholder; (v) limiting the time allotted to questions or comments by participants; (vi) determining when the polls should be
opened and closed for voting; (vii) taking such actions as are necessary or appropriate to maintain order, decorum, safety and security at the meeting;
(viii) removing any stockholder who refuses to comply with meeting procedures, rules or guidelines as established by the chairman of the meeting; (ix) adjourning
the meeting to a later date, time and place announced at the meeting by the chairman; and (x) complying with any state and local laws and regulations concerning
safety and security. Unless otherwise determined by the chairman of the meeting, meetings of stockholders shall not be required to be held in accordance with the
rules of parliamentary procedure.
SECTION 9. LISTS OF STOCKHOLDERS. The Secretary shall prepare and make, at least ten (10) days before every meeting of stockholders, a complete
list of the stockholders entitled to vote at the meeting, arranged in alphabetical order, showing the address of each stockholder and the number and class of shares
registered in the name of each stockholder. Nothing contained in this Section 9 shall require the Corporation to include electronic mail addresses or other electronic
contact information on such list. Such list shall be open to the examination of any stockholder, for any purpose germane to the meeting for a period of at least ten
(10) days prior to the meeting: (i) on a reasonably accessible electronic network, provided that the information required to gain access to such list is provided with
the notice of the meeting, or (ii) during ordinary business hours, at the principal place of business of the Corporation. In the event that the Corporation determines
to make the list available on an electronic network, the Corporation may take reasonable steps to ensure that such information is available only to stockholders of
the Corporation. If the meeting is to be held at a physical location, then the list shall be produced and kept at the time and place of the meeting during the whole
time thereof, and may be inspected by any stockholder who is present. If the meeting is to be held solely by means of remote communications, then the list shall be
open to the examination of any stockholder during the whole time of the meeting on a reasonably accessible electronic network, and the information required to
access such list shall be provided with the notice of the meeting. The stock ledger shall be the only evidence as to who are the stockholders entitled to examine the
stock ledger, the list required by this Section 9 or the books of the Corporation, or to vote in person or by proxy at any meeting of stockholders. (Del Code Ann.,
tit. 8, §219).
SECTION 10. ACTION WITHOUT A MEETING. Unless otherwise provided by the Certificate, any action required by applicable law to be taken at any
annual or special meeting of stockholders, or any action which may be taken at such meetings, may be taken without a meeting, without prior notice and without a
vote, if a consent in writing, setting forth the action so taken, shall be signed by the holders of outstanding stock having not less than the minimum number of votes
that would be necessary to authorize or take such action at a meeting at which all shares entitled to vote were present and voted. Prompt notice of the taking of the
corporate action without a meeting by less than unanimous written consent shall be given to those stockholders who have not consented in writing. (Del. Code
Ann., tit. 8, § 228).
SECTION 11. ADJOURNMENT. At any meeting of the stockholders of the Corporation, whether annual or special, the chairman of the meeting or the
holders of a majority of the votes entitled to be cast by the stockholders who are present in person or represented by proxy may adjourn the meeting from time to
time, without notice other than announcement at the meeting, whether or not a quorum is present. At any such adjourned meeting at which a quorum may be
present, any business may be transacted which might have been transacted at the meeting as originally called. If the adjournment is for more than thirty (30) days
or if after the adjournment a new record date is fixed for the adjourned meeting, a notice of the adjourned meeting shall be given to each stockholder of record
entitled to vote at the meeting. (Del Code Ann., tit. 8, §222(c)).
SECTION 12. NOTICE OF STOCKHOLDER PROPOSALS.
(a) At any annual meeting of the stockholders, only such business shall be conducted as shall have been properly brought before such meeting. To be
properly brought before an annual meeting, business must be (i) specified in the notice of meeting (or any supplement thereto) given by or at the direction of the
Board, (ii) otherwise properly brought before the meeting by or at the direction of the Board, or (iii) otherwise properly and timely brought before the meeting by
any stockholder of the Corporation in compliance with the notice procedures and other provisions of this Section 12.
(b) For business to be properly brought before an annual meeting by a stockholder, such business must be a proper subject for stockholder action under the
DGCL and other applicable law, as determined by the Chairman of the Board or such other person as is presiding over the meeting, and such stockholder (i) must
be a stockholder of record on the date of the giving of the notice provided for in this Section 12 and on the record date for the determination of stockholders
entitled to vote at such annual meeting, (ii) must be entitled to vote at such annual meeting, and (iii) must comply with the notice procedures set forth in this
Section 12. In addition to any other applicable requirements, for business to be properly brought before an annual meeting by a stockholder, such stockholder must
have given timely notice thereof in proper written form to the Secretary.
(c) To be timely, a stockholder’s notice must be delivered to, or mailed and received by, the Secretary of the Corporation (the “ Secretary ”) at the principal
executive offices of the Corporation not earlier than the close of business on the one hundred twentieth (120th) calendar day, and not later than the close of
business on the ninetieth (90th) calendar day, prior to the first anniversary of the immediately preceding year’s annual meeting of stockholders; provided , however
, that in the event that no annual meeting was held in the previous year or the annual meeting is called for a date that is more than thirty (30) calendar days earlier
or more than sixty (60) calendar days later than such anniversary date, notice by the stockholder in order to be timely must be so delivered or received not earlier
than the close of business on the one hundred twentieth (120 th ) calendar day prior to the date of such annual meeting and not later than the close of business on the
later of the ninetieth (90 th ) calendar day prior to the date of such annual meeting or, if the first pubic disclosure of the date of such annual meeting is less than one
hundred (100) calendar days prior to the date of such annual meeting, the tenth (10th) calendar day following the day on which public disclosure of the date of such
annual meeting is first made by the Corporation. In no event shall any adjournment or postponement of an annual meeting or the public disclosure thereof
commence a new time period (or extend any time period) for the giving of a stockholder’s notice as described above.
(d) To be in proper written form, a stockholder’s notice to the Secretary shall set forth in writing, as to each matter the stockholder proposes to bring before
the meeting, the following: (i) a description of the business desired to be brought before the meeting, including the text of the proposal or business and the text of
any resolutions proposed for consideration; (ii) the name and record address, as they appear on the Corporation’s stock ledger, of such stockholder and the name
and address of any Stockholder Associated Person; (iii) (A) the class and series and number of shares of each class and series of capital stock of the Corporation
which are, directly or indirectly, owned beneficially and/or of record by such stockholder or any Stockholder Associated Person, documentary evidence of such
record or beneficial ownership, and the date or dates such shares were acquired and the investment intent at the time such shares were acquired, (B) any Derivative
Instrument directly or indirectly owned beneficially by such stockholder or any Stockholder Associated Person and any other direct or indirect right held by such
stockholder or any Stockholder Associated Person to profit from, or share in any profit derived from, any increase or decrease in the value of shares of the
Corporation, (C) any proxy, contract, arrangement, understanding, or relationship pursuant to which such stockholder or any Stockholder Associated Person has a
right to vote any securities of the Corporation, (D) any Short Interest indirectly or directly held by such stockholder or any Stockholder Associated Person in any
security issued by the Corporation, (E) any rights to dividends on the shares of the Corporation owned beneficially by such stockholder or any Stockholder
Associated Person that are separated or separable from the underlying securities of the Corporation, (F) any proportionate interest in securities of the Corporation
or Derivative Instruments held, directly or indirectly, by a general or limited partnership in which such stockholder or any Stockholder Associated Person is a
general partner or, directly or indirectly, beneficially owns an interest in a general partner, and (G) any performance-related fees (other than an asset-based fee) that
such stockholder or any Stockholder Associated Person is entitled to based on any increase or decrease in the value of securities of the Corporation or Derivative
Instruments, if any, as of the date of such notice, including without limitation any such interests held by members of such stockholder’s or any Stockholder
Associated Person’s immediate family sharing
the same household (which information, in each case, shall be supplemented by such stockholder and any Stockholder Associated Person not later than ten
(10) calendar days after the record date for the meeting to disclose such ownership as of the record date); (iv) a description of all arrangements or understandings
between such stockholder and/or any Stockholder Associated Person and any other person or persons (naming such person or persons) in connection with the
proposal of such business by such stockholder; (v) any material interest of such stockholder or any Stockholder Associated Person in such business, individually or
in the aggregate, including any anticipated benefit to such stockholder or any Stockholder Associated Person therefrom; (vi) a representation from such stockholder
as to whether the stockholder or any Stockholder Associated Person intends or is part of a group which intends (1) to deliver a proxy statement and/or form of
proxy to holders of at least the percentage of the Corporation’s outstanding capital stock required to approve or adopt the proposal and/or (2) otherwise to solicit
proxies from stockholders in support of such proposal; (vii) a representation that such stockholder is a holder of record of stock of the Corporation entitled to vote
at such meeting, that such stockholder intends to vote such stock at such meeting, and that such stockholder intends to appear at the meeting in person or by proxy
to bring such business before such meeting; (viii) whether and the extent to which any agreement, arrangement or understanding has been made, the effect or intent
of which is to increase or decrease the voting power of such stockholder or any Stockholder Associated Person with respect to any securities of the Corporation,
without regard to whether such transaction is required to be reported on a Schedule 13D or other form in accordance with Section 13(d) of the Exchange Act or any
successor provisions thereto and the rules and regulations promulgated thereunder; (ix) in the event that such business includes a proposal to amend these Bylaws,
the complete text of the proposed amendment; and (x) such other information regarding each matter of business to be proposed by such stockholder, regarding the
stockholder in his or her capacity as a proponent of a stockholder proposal, or regarding any Stockholder Associated Person, that would be required to be disclosed
in a proxy statement or other filings required to be made with the SEC in connection with the solicitations of proxies for such business pursuant to Section 14 of
the Exchange Act (or pursuant to any law or statute replacing such section) and the rules and regulations promulgated thereunder.
(e) If the information submitted pursuant to this Section 12 by any stockholder proposing business for consideration at an annual meeting shall be inaccurate
to any material extent, such information may be deemed not to have been provided in accordance with this Section 12. Upon written request by the Secretary, the
Board or any committee thereof, any stockholder proposing business for consideration at an annual meeting shall provide, within seven (7) business days of
delivery of such request (or such other period as may be specified in such request), written verification, satisfactory in the discretion of the Board, any committee
thereof or any authorized officer of the Corporation, to demonstrate the accuracy of any information submitted by the stockholder pursuant to this Section 12. If a
stockholder fails to provide such written verification within such period, the information as to which written verification was requested may be deemed not to have
been provided in accordance with this Section 12.
(f) For purposes of these Bylaws, “ public disclosure ” shall be deemed to include a disclosure made in a (A) press release reported by the Dow Jones News
Service, Reuters Information Service, Associated Press or any comparable or successor national news wire service, or (B) in a document filed by the Corporation
with the SEC pursuant to Section 13, 14 or 15(d) of the Exchange Act or any successor provisions thereto.
(g) No business (other than nominations of persons for election to the Board which shall be made in accordance with the procedures set forth in Section 17 of
these Bylaws) shall be conducted at the annual meeting of stockholders except business brought before the annual meeting in accordance with the procedures set
forth in this Section 12.
(h) Except as otherwise required by the DGCL and other applicable law, the Certificate or these Bylaws, the Chairman of the Board or other person presiding
at an annual meeting shall have the power and duty (i) to determine whether any business proposed to be brought before the annual meeting was properly brought
before the meeting in accordance with the procedures set forth in this Section 12, including whether the stockholder or any Stockholder Associated Person on
whose behalf the proposal is made, solicited (or is part of a group which solicited) or did not so solicit, as the case may be, proxies in support of such stockholder’s
proposal in compliance with such stockholder’s representation as required by this Section 12, and (ii) if any proposed business was not brought in compliance with
this Section 12, to declare that such proposal is defective and shall be disregarded.
(i) In addition to the provisions of this Section 12, a stockholder shall also comply with all applicable requirements of the DGCL, other applicable law and
the Exchange Act, and the rules and regulations thereunder,
with respect to the matters set forth herein, provided , however , that any references in these Bylaws to the Exchange Act or the rules promulgated thereunder are
not intended to and shall not limit the requirements applicable to stockholder proposals to be considered pursuant to Section 12(a)(iii) of these Bylaws.
(j) Nothing in this Section 12 shall be deemed to affect any rights (i) of stockholders to request the inclusion of proposals in the Corporation’s proxy
statement pursuant to Rule 14a-8 under the Exchange Act, or (ii) of the holders of any series of preferred stock to elect directors pursuant to any applicable
provision of the Certificate.
(k) Notwithstanding anything in this Section 12 to the contrary, a stockholder intending to nominate one or more persons for election as a director at any
meeting of stockholders must comply with Section 17 of these Bylaws for any such nomination to be properly brought before such meeting.
ARTICLE III
BOARD OF DIRECTORS
SECTION 13. POWERS. The property, business and affairs of the Corporation shall be managed by, or under the direction of, the Board. The Board may
exercise all such powers of the Corporation and do all such lawful acts and things as are not by statute, regulation, the Certificate or these Bylaws directed or
required to be exercised or done by the stockholders. (Del Code Ann., tit. 8, § 141(a)).
SECTION 14. NUMBER. The authorized number of directors shall be no less than one nor more than nine. Within the foregoing limits, the number of
directors shall be fixed from time to time by resolution adopted by the Board. (Del Code Ann., tit. 8, §§ 141(b)).
SECTION 15. TERM. The Board shall be elected by the stockholders at their annual meeting, and each director shall be elected to serve for the term of one
year and until his successor shall be elected and qualify or until his earlier death, resignation or removal. No decrease in the number of directors constituting the
Board shall shorten the term of any incumbent director. (Del Code Ann., tit. 8, §§ 211(b), (c)).
SECTION 16. QUALIFICATIONS.
(a) Each director shall be at least 21 years of age. Directors need not be stockholders of the Corporation. (Del Code Ann., tit. 8, § 141(b)).
(b) Each director and nominee for election as a director of the Corporation must deliver to the Secretary at the principal office of the Corporation a written
questionnaire with respect to the background and qualifications of such person (which questionnaire shall be provided by the Secretary upon written request and
approved from time to time by the Board or its Nominating and Corporate Governance Committee) and a written representation and agreement (in the form
provided by the Secretary upon written request) (the “ Prospective Director Agreement ”). The Prospective Director Agreement (i) shall provide that such person
(A) is not and will not become a party to (1) any agreement, arrangement or understanding with, and has not given any commitment or assurance to, any person or
entity as to how such person, if such person is at the time a director or is subsequently elected as a director of the Corporation, will act or vote on any issue or
question (a “ Voting Commitment ”) that has not been disclosed to the Corporation, or (2) any Voting Commitment that could limit or interfere with such person’s
ability to comply, if such person is at the time a director or is subsequently elected as a director of the Corporation, with such person’s duties as a director under
applicable law, (B) is not and will not become a party to any agreement, arrangement or understanding with any person or entity other than the Corporation with
respect to any direct or indirect compensation, reimbursement or indemnification in connection with service or action as a director that has not been disclosed
therein, and (C) would be in compliance, if elected as a director of the Corporation, and will, if such person is at the time a director or is subsequently elected as a
director of the Corporation, comply with all applicable corporate governance, conflicts of interest, confidentiality, corporate opportunities, securities ownership and
stock trading policies, and other policies and guidelines of the Corporation (copies of which shall be provided by the Secretary upon written request), and (ii) shall
include, if such person is at the time a director or is subsequently elected as a director of the Corporation, such person’s irrevocable resignation as a director if such
person is found by
a court of competent jurisdiction to have breached the Prospective Director Agreement in any material respect. (Del Code Ann., tit. 8, § 141(b)).
SECTION 17. NOTICE OF NOMINATIONS FOR DIRECTORS.
(a) Annual Meetings of Stockholders .
(1) Nominations of persons for election to the Board at an annual meeting of stockholders may be made (A) by or at the direction of the Board or a
committee appointed by the Board, or (B) by any stockholder of the Corporation (i) who is a stockholder of record on the date of the giving of the notice provided
for in this Section 17(a), on the record date for the determination of the stockholders entitled to vote at such annual meeting of stockholders and at the time of such
annual meeting of stockholders, (ii) who is entitled to vote at the annual meeting of stockholders, and (iii) who complies with the notice procedures set forth in this
Section 17(a) as to such nominations, including, but not limited to, the procedures regarding such notice’s timeliness and required form.
(2) For a stockholder’s notice of nomination of persons for election to the Board at an annual meeting of stockholders to be brought before an annual
meeting by a stockholder pursuant to Section 17(a)(1)(B) of these Bylaws, the stockholder must have given timely notice thereof, in proper written form, to the
Secretary. To be considered timely, a stockholder’s notice of nomination must be delivered to, or mailed and received by, the Secretary at the principal executive
offices of the Corporation not earlier than the close of business on the one hundred twentieth (120th) calendar day, and not later than the close of business on the
ninetieth (90th) calendar day, prior to the first anniversary of the immediately preceding year’s annual meeting; provided, however, that in the event that no annual
meeting was held in the previous year or the annual meeting is called for a date that is more than thirty (30) calendar days earlier or more than sixty (60) calendar
days later than such anniversary date, notice by the stockholder in order to be timely must be so delivered or received not earlier than the close of business on the
one hundred twentieth (120 th ) calendar day prior to the date of such annual meeting and not later than the close of business on the later of the ninetieth (90 th )
calendar day prior to the date of such annual meeting or, if the first public disclosure of the date of such annual meeting is less than one hundred (100) calendar
days prior to the date of such annual meeting, the tenth (10th) calendar day following the day on which public disclosure of the date of such annual meeting is first
made by the Corporation. In no event shall any adjournment or postponement of an annual meeting or the public disclosure thereof commence a new time period
(or extend any time period) for the giving of a stockholder’s notice as described above.
To be in proper written form, a stockholder’s notice of nomination to the Secretary (whether given pursuant to this Section 17(a) or Section 17(b) of these
Bylaws) shall set forth in writing the following: (a) as to each person whom the stockholder proposes to nominate for election or reelection as a director (i) the
name, age, business address and residence address of such person; (ii) the principal occupation and employment of such person; (iii) the class and series and
number of shares of each class and series of capital stock of the Corporation which are owned beneficially or of record by such person (which information shall be
supplemented not later than ten (10) calendar days after the record date for the meeting to disclose such ownership as of the record date); (iv) such person’s
executed written consent to being named in the proxy statement as a nominee and to serving as a director if elected; (v) all information relating to such person that
would be required to be disclosed in a proxy statement or other filings required to be made with the SEC in connection with the solicitation of proxies for the
election of directors in a contested election pursuant to Section 14 of the Exchange Act (or pursuant to any law or statute replacing such section), and the rules and
regulations promulgated thereunder; (vi) a description of all direct and indirect compensation and other material monetary agreements, arrangements and
understandings during the past three years, and any other material relationships, between or among such person being nominated, on the one hand, and the
stockholder and any Stockholder Associated Person, on the other hand, including, without limitation all information that would be required to be disclosed
pursuant to Item 404 promulgated under Regulation S-K of the Exchange Act if the stockholder making the nomination and any Stockholder Associated Person
were the “registrant” for purposes of such rule and the person being nominated were a director or executive officer of such registrant; and (vii) the information and
agreement required under Section 16 of these Bylaws; and (b) as to the stockholder giving the notice (i) the name and record address of such stockholder, as they
appear on the Corporation’s stock ledger, and the name and address of any Stockholder Associated Person; (ii) (A) the class and series and number of shares of
each class and series of capital stock of the Corporation which are, directly or indirectly, owned beneficially and/or of record by such stockholder or any
Stockholder Associated Person,
documentary evidence of such record or beneficial ownership, and the date or dates such shares were acquired and the investment intent at the time such shares
were acquired, (B) any Derivative Instrument directly or indirectly owned beneficially by such stockholder or any Stockholder Associated Person and any other
direct or indirect right held by such stockholder or any Stockholder Associated Person to profit from, or share in any profit derived from, any increase or decrease
in the value of shares of the Corporation, (C) any proxy, contract, arrangement, understanding, or relationship pursuant to which such stockholder or any
Stockholder Associated Person has a right to vote any shares of any security of the Corporation, (D) any Short Interest indirectly or directly held by such
stockholder or any Stockholder Associated Person in any security issued by the Corporation, (E) any rights to dividends on the shares of the Corporation owned
beneficially by such stockholder or any Stockholder Associated Person that are separated or separable from the underlying shares of the Corporation, (F) any
proportionate interest in shares of the Corporation or Derivative Instruments held, directly or indirectly, by a general or limited partnership in which such
stockholder or any Stockholder Associated Person is a general partner or, directly or indirectly, beneficially owns an interest in a general partner, and (G) any
performance-related fees (other than an asset-based fee) that such stockholder or any Stockholder Associated Person is entitled to based on any increase or
decrease in the value of shares of the Corporation or Derivative Instruments, if any, as of the date of such notice, including without limitation any such interests
held by members of such stockholder’s or any Stockholder Associated Person’s immediate family sharing the same household (which information shall, in each
case, be supplemented by such stockholder and any Stockholder Associated Person not later than ten (10) calendar days after the record date for the meeting to
disclose such ownership as of the record date); (iii) a description of all arrangements or understandings between such stockholder or any Stockholder Associated
Person and each proposed nominee and any other person or persons (naming such person or persons) pursuant to which the nomination(s) are to be made by such
stockholder; (iv) any material interest of such stockholder or any Stockholder Associated Person in the election of such proposed nominee, individually or in the
aggregate, including any anticipated benefit to the stockholder or any Stockholder Associated Person therefrom; (v) a representation that such stockholder is a
holder of record of stock of the Corporation entitled to vote at such meeting and that such stockholder intends to appear in person or by proxy at the meeting to
nominate the person or persons named in its notice; (vi) a representation from the stockholder as to whether the stockholder or any Stockholder Associated Person
intends or is part of a group which intends (A) to deliver a proxy statement and/or form of proxy to holders of at least the percentage of the Corporation’s
outstanding capital stock required to elect the person proposed as a nominee and/or (B) otherwise to solicit proxies from stockholders in support of the election of
such person; (vii) whether and the extent to which any agreement, arrangement or understanding has been made, the effect or intent of which is to increase or
decrease the voting power of such stockholder or such Stockholder Associated Person with respect to any shares of the capital stock of the Corporation, without
regard to whether such transaction is required to be reported on a Schedule 13D or other form in accordance with Section 13(d) of the Exchange Act or any
successor provisions thereto and the rules and regulations promulgated thereunder; and (viii) any other information relating to such stockholder and any
Stockholder Associated Person that would be required to be disclosed in a proxy statement or other filings required to be made with the SEC in connection with
solicitations of proxies for the election of directors in a contested election pursuant to Section 14 of the Exchange Act (or pursuant to any law or statute replacing
such section) and the rules and regulations promulgated thereunder. In addition to the information required above, the Corporation may require any proposed
nominee to furnish such other information as may reasonably be required by the Corporation to determine the eligibility of such proposed nominee to serve as an
independent director of the Corporation or that could be material to a reasonable stockholder’s understanding of the independence, or lack thereof, of such
nominee.
(3) Notwithstanding anything in this Section 17 to the contrary, in the event that the number of directors to be elected to the Board at an annual
meeting of the stockholders is increased and there is no public disclosure by the Corporation, naming all of the nominees for directors or specifying the size of the
increased Board, at least ninety (90) calendar days prior to the first anniversary of the date of the immediately preceding year’s annual meeting, a stockholder’s
notice required by this Section 17 shall also be considered timely, but only with respect to nominees for any new positions created by such increase, if it shall be
delivered to, or mailed and received by, the Secretary at the principal executive offices of the Corporation not later than the close of business on the tenth (10 th )
calendar day following the day on which such public disclosure is first made by the Corporation.
(b) Special Meetings of Stockholders . Nominations of persons for election to the Board may be made at a special meeting of stockholders at which
directors are to be elected (i) pursuant to the Corporation’s notice of meeting, (ii) by or at the direction of the Board, or (iii) provided that the Board has determined
that directors shall be
elected at such meeting, by any stockholder of the Corporation who (A) is a stockholder of record at the time of giving of notice provided for in this Section 17(b),
(B) is a stockholder of record on the record date for the determination of the stockholders entitled to vote at such meeting, (C) is a stockholder of record at the time
of such meeting, (D) is entitled to vote at such meeting, and (E) complies with the notice procedures set forth in this Section 17(b) as to such nomination. In the
event the Corporation calls a special meeting of stockholders for the purpose of electing one or more directors to the Board, any such stockholder may nominate a
person or persons (as the case may be) for election to such position(s) as specified in the Corporation’s notice of meeting, if the proper form of stockholder’s notice
required by Section 17(a)(2) of these Bylaws with respect to any nomination shall be delivered to the Secretary at the principal executive offices of the Corporation
not earlier than the close of business on the one hundred twentieth (120 th ) calendar day prior to the date of such special meeting and not later than the close of
business on the later of the ninetieth (90 th ) calendar day prior to the date of such special meeting or, if the first pubic disclosure made by the Corporation of the
date of such special meeting is less than one hundred (100) days prior to the date of such special meeting, not later than the tenth (10 th ) calendar day following the
day on which public disclosure is first made of the date of the special meeting and of the nominees proposed by the Board to be elected at such meeting. In no
event shall any adjournment or postponement of a special meeting or the public disclosure thereof commence a new time period (or extend any time period) for the
giving of a stockholder’s notice as described above.
(c) General .
(1) If the information submitted pursuant to this Section 17 by any stockholder proposing a nominee for election as a director at a meeting of
stockholders shall be inaccurate to any material extent, such information may be deemed not to have been provided in accordance with this Section 17. Upon
written request by the Secretary, the Board or any committee thereof, any stockholder proposing a nominee for election as a director at a meeting shall provide,
within seven (7) business days of delivery of such request (or such other period as may be specified in such request), written verification, satisfactory in the
discretion of the Board, any committee thereof or any authorized officer of the Corporation, to demonstrate the accuracy of any information submitted by the
stockholder pursuant to this Section 17. If a stockholder fails to provide such written verification within such period, the information as to which written
verification was requested may be deemed not to have been provided in accordance with this Section 17.
(2) Notwithstanding anything in these Bylaws to the contrary, no person shall be eligible for election as a director of the Corporation at any meeting of
stockholders unless nominated in accordance with the procedures set forth in this Section 17.
(3) Notwithstanding anything in these Bylaws to the contrary, if a stockholder who has submitted a written notice of intention to propose a nominee
for election as a director at a meeting of stockholders (or a designated representative of the stockholder) does not appear at the annual or special meeting of
stockholders of the Corporation to present the nomination, such nomination shall be disregarded notwithstanding that proxies in respect of such vote may have
been received by the Corporation.
(4) Except as otherwise required by the DGCL and other applicable law, the Certificate or these Bylaws, the Chairman of the Board or other person
presiding at the meeting shall have the power and duty (a) to determine whether any nomination proposed to be brought before the meeting was properly made in
accordance with the procedures set forth in this Section 17, including whether the stockholder or any Stockholder Associated Person on whose behalf the
nomination is made, solicited (or is part of a group which solicited) or did not so solicit, as the case may be, proxies in support of the election of such stockholder’s
nominee(s) in compliance with such stockholder’s representation as required by this Section 17, and (b) if any proposed nomination was not made in compliance
with this Section 17, to declare that such nomination is defective and shall be disregarded.
(5) In addition to the provisions of this Section 17, a stockholder shall also comply with all applicable requirements of the DGCL, other applicable law
and the Exchange Act, and the rules and regulations thereunder, with respect to the matters set forth herein, provided , however , that any references in these
Bylaws to the Exchange Act or the rules promulgated thereunder are not intended to and shall not limit the applicable requirements for nominations by
stockholders to be considered pursuant to Section 17(a) or Section 17(b) of these Bylaws.
(6) Nothing in this Section 17 shall be deemed to affect any rights of the holders of any series of Preferred Stock, if and to the extent provided for,
under applicable law, the Certificate or these Bylaws.
SECTION 18. RESIGNATIONS. Any director may resign at any time by giving written notice thereof to the Board, the Chairman of the Board, the Chief
Executive Officer or the Secretary. Such resignation shall take effect at the time specified therein or, if the time is not specified therein, upon receipt thereof; and,
unless otherwise specified therein, the acceptance of such resignation shall not be necessary to make it effective. (Del Code Ann., tit. 8, § 141(b)).
SECTION 19. REMOVAL. Any director or the entire Board may be removed, either for or without cause, at any time, by the affirmative vote of the holders
of a majority of the shares entitled to vote at an election of directors at any annual or special meeting of the stockholders called for that purpose. For purposes of
this Section 19, “c ause ” shall mean (a) a final conviction of a felony involving moral turpitude, or (b) willful misconduct that is materially and demonstrably
injurious economically to the Corporation. For purposes of this definition of “cause,” no act, or failure to act, by a director shall be considered “willful” unless
committed in bad faith and without a reasonable belief that the act or failure to act was in the best interest of the Corporation or any affiliate of the Corporation.
“Cause” shall not exist unless and until the Corporation has delivered to the director a written notice of the director’s failure to act that constitutes “cause” and, if
cure is possible, such director shall not have cured such act or omission within ninety (90) days after the delivery of such notice. (Del Code Ann., tit. 8, § 141(k)).
SECTION 20. VACANCIES AND NEWLY CREATED DIRECTORSHIPS. Vacancies in the Board, whether resulting from death, resignation,
disqualification, removal or other causes, and any newly created directorships resulting from any increase in the number of directors, shall, unless the Board
determines by resolution that any such vacancy or newly created directorships shall be filled by the stockholders, be filled only by the affirmative vote of a
majority of the directors then in office, even though less than a quorum, or by a sole remaining director. Any director elected in accordance with the preceding
sentence shall hold office for the remainder of the full term of the director for which the vacancy was created or occurred and until such director’s successor shall
have been elected and qualified, except in the event of his or her earlier death, resignation, disqualification or removal. (Del Code Ann., tit. 8, § 223).
SECTION 21. MEETINGS.
(a) Organizational Meetings . The newly elected directors shall hold their first meeting to organize the Corporation, elect officers and transact any other
business which may properly come before the meeting. An annual organizational meeting of the Board shall be held immediately after each annual meeting of the
stockholders, or at such time and place as may be noticed for the meeting.
(b) Regular Meetings . Regular meetings of the Board may be held without notice at such places and times as shall be determined from time to time by
resolution of the directors. (Del Code Ann., tit. 8, § 141(g)).
(c) Special Meetings . Special meetings of the Board shall be called by the Chief Executive Officer or by the Secretary on the written request of any director
with at least two days’ notice to each director and shall be held at such place as may be determined by the directors or as shall be stated in the notice of the
meeting. (Del Code Ann., tit. 8, § 141(g)).
SECTION 22. QUORUM, VOTING AND ADJOURNMENT. A majority of the total number of directors or any committee thereof, but not less than one
(1), shall constitute a quorum for the transaction of business. The affirmative vote of a majority of the directors present at a meeting at which a quorum is present
shall be the act of the Board, unless a different vote is required by applicable law, the Certificate or these Bylaws. In the absence of a quorum, a majority of the
directors present thereat may adjourn such meeting to another time and place. Notice of such adjourned meeting need not be given if the time and place of such
adjourned meeting are announced at the meeting so adjourned. (Del Code Ann., tit. 8, § 141(b)).
SECTION 23. COMMITTEES. The Board may, by resolution passed by a majority of the Board, designate one or more committees, including but not
limited to an Executive Committee and an Audit Committee, each such committee to consist of one or more of the directors of the Corporation. The Board may
designate one or more
directors as alternate members of any committee to replace any absent or disqualified member at any meeting of the committee. Any such committee, to the extent
provided in the resolution of the Board, shall have and may exercise all the powers and authority of the Board in the management of the business and affairs of the
Corporation and may authorize the seal of the Corporation to be affixed to all papers which may require it; but no such committee shall have the power or authority
to amend the Certificate of Incorporation, adopt an agreement of merger or consolidation, recommend to the stockholders the sale, lease, or exchange of all or
substantially all of the Corporation’s properties and assets, recommend to the stockholders a dissolution of the Corporation or a revocation of a dissolution or to
amend these Bylaws. Unless a resolution of the Board expressly provides, no such committee shall have the power or authority to declare a dividend or to authorize
the issuance of stock of the Corporation. All committees of the Board shall report their proceedings to the Board when required. (Del Code Ann., tit. 8, § 141(c)).
SECTION 24. ACTION WITHOUT A MEETING. Unless otherwise restricted by the Certificate or these Bylaws, any action required or permitted to be
taken at any meeting of the Board or of any committee thereof may be taken without a meeting if all members of the Board or any committee thereof consent
thereto in writing, or by electronic transmission, and the writing or writings or electronic transmissions are filed with the minutes of proceedings of the Board of
Directors or committee. Such filing shall be in paper form if the minutes are maintained in paper form and shall be in electronic form if the minutes are maintained
in electronic form (Del Code Ann., tit. 8, § 141(f)).
SECTION 25. COMPENSATION. Directors shall be entitled to such compensation for their services as may be approved by the Board, including, if so
approved, by resolution of the Board, a fixed sum and expenses of attendance, if any, for attendance at each regular or special meeting of the Board and at any
meeting of a committee of the Board. Nothing herein contained shall be construed to preclude any Director from serving the corporation in any other capacity as an
officer, agent, employee, or otherwise and receiving compensation therefor. (Del Code Ann., tit. 8, § 141(h)).
SECTION 26. MEETING BY ELECTRONIC COMMUNICATIONS EQUIPMENT. Any member of the Board, or of any committee thereof, may
participate in a meeting by means of conference telephone or other communications equipment by means of which all persons participating in the meeting can hear
each other, and participation in a meeting by such means shall constitute presence in person at such meeting. (Del. Code Ann., tit. 8, § 141(i)).
ARTICLE IV
OFFICERS
SECTION 27. OFFICERS. The officers of the Corporation shall be a Chairman of the Board, a Chief Executive Officer, a President, a Chief Operating
Officer, a Chief Financial Officer, one or more Vice-Presidents, a Secretary, a Treasurer and such other officers and assistant officers as the Board may from time
to time deem advisable. Except for the Chairman of the Board, Chief Executive Officer, President, Chief Operating Officer, Chief Financial Officer and Secretary,
the Board may refrain from filling any of the said offices at any time and from time to time. Any number of offices may be held by the same person. The following
officers shall be elected by the Board at the time, in the manner and for such terms as the Board from time to time shall determine: Chairman of the Board, Chief
Executive Officer, President, Chief Operating Officer, Chief Financial Officer and Secretary. The Chief Executive Officer may appoint such other officers and
assistant officers as he may deem advisable provided such officers or assistant officers have a title no higher than Vice-President, who shall hold office for such
periods as the Chief Executive Officer shall determine. (Del. Code Ann., tit. 8, §§ 122(5), 142(a), (b)).
SECTION 28. CHAIRMAN OF THE BOARD. The Chairman of the Board shall be a member of the Board and shall preside at all meetings of the Board
and of the stockholders. In addition, the Chairman of the Board shall have such powers and perform such other duties as from time to time may be assigned to him
by the Board. (Del. Code Ann., tit. 8, § 142(a)).
SECTION 29. CHIEF EXECUTIVE OFFICER. The Chief Executive Officer shall have general supervision of all of the departments and business of the
Corporation; he or she shall prescribe the duties of the other officers and employees and see to the proper performance thereof. The Chief Executive Officer shall
be responsible for
having all orders and resolutions of the Board carried into effect. The Chief Executive Officer shall execute on behalf of the Corporation and may affix or cause to
be affixed a seal to all authorized documents and instruments requiring such execution, except to the extent that signing and execution thereof shall have been
delegated to some other officer or agent of the Corporation by the Board or by the Chief Executive Officer. The Chief Executive Officer shall be a member of the
Board. In the absence or disability of the Chairman of the Board or his or her refusal to act, the Chief Executive Officer shall preside at meetings of the Board. In
general, the Chief Executive Officer shall perform all the duties and exercise all the powers and authorities incident to his or her office or as prescribed by the
Board. (Del. Code Ann., tit. 8, § 142(a)).
SECTION 30. PRESIDENT. The President shall perform such duties as customarily pertain to the office of President or are prescribed by the Board or Chief
Executive Officer. In the absence, disability or refusal of the Chief Executive Officer to act, or the vacancy of such office, the President shall perform the duties
and have the powers and authorities of the Chief Executive Officer. (Del. Code Ann., tit. 8, § 142(a)).
SECTION 31. CHIEF OPERATING OFFICER. The Chief Operating Officer shall perform such duties as customarily pertain to the office of Chief
Operating Officer or are prescribed by the Board, Chief Executive Officer or President. In the absence, disability or refusal of the President to act, or the vacancy
of such office, the Chief Operating Officer shall perform the duties and have the powers and authorities of the President. (Del. Code Ann., tit. 8, § 142(a)).
SECTION 32. CHIEF FINANCIAL OFFICER. The Chief Financial Officer shall be the principal financial and accounting officer of the Corporation and
shall have such other duties as may be prescribed by the Board, Chief Executive Officer or President. (Del. Code Ann., tit. 8, § 142(a)).
SECTION 33. VICE PRESIDENTS. Each Vice President, if any are elected, of whom one or more may be designated an Executive and/or Senior Vice
President, shall have such powers, shall perform such duties and shall be subject to such supervision as may be prescribed by the Board, the Chief Executive
Officer, the President or the Chief Operating Officer. In the event of the absence or disability of the Chief Executive Officer or the President or their refusal to act,
the Vice-Presidents, in the order of their rank, and within the same rank in the order of their seniority, shall perform the duties and have the powers and authorities
of the Chief Executive Officer and President, except to the extent inconsistent with applicable law. (Del. Code Ann., tit. 8, § 142(a)).
SECTION 34. TREASURER. The Treasurer, if one is elected, shall have custody of the corporate funds, securities, evidences of indebtedness and other
valuables of the Corporation and shall keep full and accurate accounts of receipts and disbursements in books belonging to the Corporation. He shall deposit all
moneys and other valuables in the name and to the credit of the Corporation in such depositories as may be designated by the Board. The Treasurer shall disburse
the funds of the Corporation, taking proper vouchers therefor. He shall render to the Chief Executive Officer and the Board, upon their request, a report of the
financial condition of the Corporation. If required by the Board, he shall give the Corporation a bond for the faithful discharge of his duties in such amount and
with such surety as the Board shall prescribe. The Treasurer shall have such further powers and perform such other duties incident to the office of Treasurer as
from time to time are assigned to him by the Board. (Del. Code Ann., tit. 8, § 142(a)).
SECTION 35. SECRETARY. The Secretary shall be the Chief Administrative Officer of the Corporation and shall: (a) cause minutes of all meetings of the
stockholders and directors to be recorded and kept; (b) cause all notices required by these Bylaws or otherwise to be given properly; (c) see that the minute books,
stock books, and other nonfinancial books, records and papers of the Corporation are kept properly; and (d) cause all reports, statements, returns, certificates and
other documents to be prepared and filed when and as required. The Secretary shall keep a seal of the Corporation, and, when authorized by the Board, Chief
Executive Officer or the President, cause the seal to be affixed to any documents and instruments requiring it. The Secretary shall act under the supervision of the
Chief Executive Officer and President or such other officer as the Chief Executive Officer or President may designate. The Secretary shall have such further
powers and perform such other duties as prescribed from time to time by the Board, Chief Executive Officer, President or such other supervising officer as the
Chief Executive Officer or President may designate. (Del. Code Ann., tit. 8, § 142(a)).
SECTION 36. ASSISTANT TREASURERS AND ASSISTANT SECRETARIES. Each Assistant Treasurer and each Assistant Secretary, if any are elected,
shall be vested with all the powers and shall perform all the duties of the Treasurer and Secretary, respectively, in the absence or disability of such officer, unless or
until the Board shall otherwise determine. In addition, Assistant Treasurers and Assistant Secretaries shall have such powers and shall perform such duties as shall
be assigned to them by the Board. (Del. Code Ann., tit. 8, § 142(a)).
SECTION 37. DELEGATION OF DUTIES. In the absence, disability or refusal of any officer to exercise and perform his duties, the Board may delegate to
another officer such powers or duties.
SECTION 38. RESIGNATION. Any officer may resign at any time by giving notice in writing or by electronic transmission to the Board or to the President
or to the Secretary. Any such resignation shall be effective when received by the person or persons to whom such notice is given, unless a later time is specified
therein, in which event the resignation shall become effective at such later time. Unless otherwise specified in such notice, the acceptance of any such resignation
shall not be necessary to make it effective. Any resignation shall be without prejudice to the rights, if any, of the Corporation under any contract with the resigning
officer. (Del. Code Ann., tit. 8, § 142(b)).
SECTION 39. REMOVAL. Any officer may be removed from office at any time, either with or without cause, by the affirmative vote of a majority of the
directors in office at the time, or by the unanimous written consent of the directors in office at the time, or by any committee or, with respect to any officer other
than the Chairman of the Board (if the Chairman of the Board is designated as an officer of the corporation by the Board), by the Chief Executive Officer or by
other superior officers upon whom such power of removal may have been conferred by the Board.
SECTION 40. VACANCIES. The Board shall have power to fill vacancies occurring in any office.
ARTICLE V
STOCK
SECTION 41. CERTIFICATES OF STOCK. The shares of the Corporation shall be represented by certificates or shall be uncertificated. Every holder of
stock of the Corporation represented by certificates shall be entitled to have a certificate, in such form as may be prescribed by applicable law and by the Board,
representing the number of shares held by such holder registered in certificate form, and signed by, or in the name of the Corporation by, the Chairman of the
Board, the Chief Executive Officer or the President or a Vice President and by the Treasurer or an Assistant Treasurer or the Secretary or an Assistant Secretary,
certifying the number and class of shares of stock in the Corporation owned by him. Any or all of the signatures on the certificate may be a facsimile. The Board
shall have the power to appoint one or more transfer agents and/or registrars for the transfer or registration of certificates of stock of any class, and may require
stock certificates to be countersigned or registered by one or more of such transfer agents and/or registrars. (Del. Code Ann., tit. 8, § 158).
SECTION 42. TRANSFER OF SHARES.
(a) Shares of stock of the Corporation shall be transferable upon its books by the holders thereof, in person or by their duly authorized attorneys or legal
representatives, upon surrender to the Corporation by delivery thereof to the person in charge of the stock and transfer books and ledgers. Such certificates shall be
cancelled and new certificates shall thereupon be issued. A record shall be made of each transfer. Whenever any transfer of shares shall be made for collateral
security, and not absolutely, it shall be so expressed in the entry of the transfer if, when the certificates are presented, both the transferor and transferee request the
Corporation to do so. (Del. Code Ann., tit. 8, § 201).
(b) The Board shall have power and authority to make such rules and regulations as it may deem necessary or proper concerning the issue, transfer and
registration of certificates for shares of stock of the Corporation. (Del. Code Ann., tit. 8, § 202).
SECTION 43. LOST CERTIFICATES. A new certificate of stock may be issued in the place of any certificate previously issued by the Corporation, alleged
to have to have been lost, stolen, destroyed or mutilated, and the Board may, in their discretion, require the owner of such lost, stolen, destroyed or mutilated
certificate, or his legal representative, to give the Corporation a bond, in such sum as the Board may direct, not exceeding double the value of the stock, in order to
indemnify the Corporation against any claims that may be made against it in connection therewith. (Del. Code Ann., tit. 8, § 167).
SECTION 44. STOCKHOLDERS OF RECORD. The Corporation shall be entitled to treat the holder of record of any share or shares of its capital stock as
the holder thereof, in fact, and shall not be bound to recognize any equitable or other claim to or interest in such shares on the part of any other person, whether or
not it shall have express or other notice thereof, except as otherwise expressly provided by the DGCL or other applicable law. (Del. Code Ann., tit. 8, § 219 (c)).
SECTION 45. RECORD DATE.
(a) Record Date for Meetings of Stockholders . For the purpose of determining the stockholders entitled to notice of, or to vote at, any meeting of
stockholders or any adjournment thereof, the directors may fix, in advance, a record date, which record date shall not precede the date upon which the resolution
fixing the record date is adopted by the Board, and which record date shall not be more than sixty (60) days nor less than ten (10) days before the date of such
meeting. If no record date is fixed, the record date for determining stockholders entitled to notice of or to vote at a meeting of stockholders shall be at the close of
business on the day next preceding the day on which notice is given, or, if notice is waived, at the close of business on the day next preceding the day on which the
meeting is held. A determination of stockholders of record entitled to notice of or to vote at any meeting of stockholders shall apply to any adjournment of the
meeting; provided , however , that the Board may fix a new record date for the adjourned meeting. (Del. Code Ann., tit. 8, § 213(a)).
(b) Record Date for Payments of Dividends and Distributions . In order that the Corporation may determine the stockholders entitled to receive payment of
any dividend or other distribution or allotment of any rights or the stockholders entitled to exercise any rights in respect of any change, conversion, or exchange of
stock or for the purpose of any other lawful action, the Board may fix a record date, which record date shall not precede the date upon which the resolution fixing
the record date is adopted, and which record date shall be not more than sixty (60) days prior to such action. If no record date is fixed, the record date for
determining stockholders for any such purpose shall be at the close of business on the day on which the Board adopts the resolution relating thereto. (Del. Code
Ann., tit. 8, § 213(c)).
(c) Record Date for Corporate Actions by Written Consent .
(i) Notwithstanding Section 45(a) and Section 45(b) of these Bylaws, the record date for determining stockholders entitled to express consent to
corporate action in writing without a meeting shall be as fixed by the Board or as otherwise established under this Section 45(c). Any person seeking to have the
stockholders authorize or take corporate action by written consent without a meeting shall, by written notice addressed to the Secretary and delivered to the
Corporation, request that a record date be fixed for such purpose. The Board may fix a record date for such purpose which shall be no more than ten (10) days after
the date upon which the resolution fixing the record date is adopted by the Board and shall not precede the date on which such resolution is adopted. If the Board
fails within ten (10) days after the Corporation receives such notice to fix a record date for such purpose, the record date shall be the day on which the first written
consent is delivered to the Corporation in the manner described in Section 45(c)(ii) below unless prior action by the Board is required under the DGCL, in which
event the record date shall be at the close of business on the day on which the Board adopts the resolution taking such prior action. (Del. Code Ann., tit. 8, § 213
(b)).
(ii) (A) Every written consent purporting to take or authorizing the taking of corporate action and/or related revocations (each such written consent
and related revocation is referred to in this Section 45(c)(ii) of these Bylaws as a “ Consent ”) shall bear the date of signature of each stockholder who signs the
Consent, and no Consent shall be effective to take the corporate action referred to therein unless, within sixty (60) days of the earliest dated
Consent delivered in the manner required by this Section 45(c)(ii), Consents signed by a sufficient number of stockholders to take such action are so delivered to
the Corporation. (Del. Code Ann., tit. 8, § 228).
(B) A Consent shall be delivered to the Corporation by delivery to its registered office in the State of Delaware, its principal place of business, or
an officer or agent of the Corporation having custody of the book in which proceedings of meetings of stockholders are recorded. Delivery to the
Corporation’s registered office shall be made by hand or by certified or registered mail, return receipt requested. (Del. Code Ann., tit. 8, § 228).
(C) In the event of the delivery to the Corporation of a Consent, the Secretary shall provide for the safe-keeping of such Consent and shall
promptly conduct such ministerial review of the sufficiency of the Consents and of the validity of the action to be taken by stockholder consent as he deems
necessary or appropriate, including, without limitation, whether the holders of a number of shares having the requisite voting power to authorize or take the action
specified in the Consent have given consent; provided, however, that if the corporate action to which the Consent relates is the removal or replacement of one or
more members of the Board, the Secretary shall promptly designate two persons, who shall not be members of the Board, to serve as inspectors with respect to
such Consent and such inspectors shall discharge the functions of the Secretary under this Section 45(c)(ii). If after such investigation the Secretary or the
inspectors (as the case may be) shall determine that the Consent is valid and that the action therein specified has been validly authorized, that fact shall forthwith be
certified on the records of the Corporation kept for the purpose of recording the proceedings of meetings of stockholders, and the Consent shall be filed in such
records, at which time the Consent shall become effective as stockholder action. In conducting the investigation required by this Section 45(c)(ii), the Secretary or
the inspectors (as the case may be) may, at the expense of the Corporation, retain special legal counsel and any other necessary or appropriate professional
advisors, and such other personnel as they may deem necessary or appropriate to assist them, and shall be fully protected in relying in good faith upon the opinion
of such counsel or advisors. (Del. Code Ann., tit. 8, § 228).
SECTION 46. DIVIDENDS. Subject to the provisions of the Certificate, the Board may at any regular or social meeting, out of funds legally available
therefor, declare dividends upon the stock of the Corporation. Before the declaration of any dividend, the Board may set apart, out of any funds of the Corporation
available for dividends, such sum or sums as from time to time in their discretion may be deemed proper for working capital or as a reserve fund to meet
contingencies or for such other purposes as shall be deemed conducive to the interests of the Corporation. (Del. Code Ann., tit. 8, §§ 170(a), 173).
SECTION 47. FRACTIONAL SHARES. The Company shall have the complete discretion to issue fractional shares. (Del. Code Ann., tit. 8, § 155).
ARTICLE VI
NOTICE AND WAIVER OF NOTICE
SECTION 48. NOTICE. Whenever any written notice is required to be given by law, the Certificate or these Bylaws, such notice, if mailed, shall be deemed
to be given when deposited in the United States mail, postage prepaid, addressed to the person entitled to such notice at his address as it appears in the books and
records of the Corporation. Such notice may also be sent by electronic transmission.
SECTION 49. WAIVER OF NOTICE. Whenever notice is required to be given under any provision of the DGCL, the Certificate or these Bylaws, a written
waiver, signed by the person entitled to notice, or a waiver by electronic transmission by the person entitled to notice, whether before or after the time stated
therein, shall be deemed equivalent to notice. Attendance of a person at a meeting shall constitute a waiver of notice of such meeting, except when the person
attends a meeting for the express purpose of objecting at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called
or convened. Neither the business to be transacted at, nor the purpose of, any regular or special meeting of the stockholders, directors or members of a committee
of directors need be specified in any written waiver of notice or any waiver by electronic transmission unless so required by the Certificate or these Bylaws. (Del.
Code Ann., tit. 8, § 229).
ARTICLE VII
AMENDMENT OF BYLAWS
SECTION 50. AMENDMENT OR REPEAL BY THE BOARD. Except as otherwise provided by the DGCL or the Certificate, these Bylaws may be
amended or repealed, in whole or in part, by the affirmative vote of not less than a majority of the Board at any regular or special meeting of the Board provided
that notice of such proposed amendment or repeal to be made is included in the notice of the meeting at which such action takes place, which shall also include,
without limitation, the text of any such proposed amendment and/or any resolution calling for any such amendment or repeal. (Del. Code Ann., tit. 8, § 109(a)).
SECTION 51. AMENDMENT OR REPEAL BY STOCKHOLDERS. Except as otherwise provided by the DGCL or the Certificate and except for the
proviso hereto, any amendment to, repeal of, or adoption of any provisions inconsistent with these Bylaws, which has not previously received the approval of the
Board, shall require for adoption the affirmative vote of the holders of a majority of the issued and outstanding shares present in person or represented by proxy at
a meeting of stockholders and entitled to vote thereat, provided , however , that, notwithstanding anything to the contrary contained herein, any amendment to,
repeal of, or adoption of any provisions inconsistent with, Sections 2, 3, 6, 12, 14, 15, 16, 17, 19, 20 and 45 of these Bylaws, this Section 51 and Article IX hereof,
which has not previously received the approval of the Board shall require for adoption the affirmative vote of the holders of not less than two-thirds of the issued
and outstanding shares entitled to vote at a duly called and convened annual or special meeting of stockholders, and provided , further, that, in addition to any other
notice required by these Bylaws and other applicable requirements contained herein, notice of such proposed amendment or repeal is included in the notice of the
meeting at which such action takes place, which shall also include, without limitation, the text of any such proposed amendment and/or any resolution calling for
any such amendment or repeal. (Del. Code Ann., tit. 8, § 109(a)).
SECTION 52. NO CONFLICT WITH THE CERTIFICATE OF INCORPORATION. No Bylaw shall be adopted, amended or repealed so as to cause such
Bylaw or these Bylaws to be inconsistent or in conflict with or violate any provision of the Certificate. (Del. Code Ann., tit. 8, § 109(b)).
ARTICLE VIII
MISCELLANEOUS
SECTION 53. SEAL. The seal of the Corporation shall be circular in form and shall have the name of the Corporation on the circumference and the
jurisdiction and year of incorporation in the center. (Del. Code Ann., tit. 8, § 122(3)).
SECTION 54. FISCAL YEAR. The fiscal year of the Corporation shall end on December 31 of each year, or such other twelve consecutive months as the
Board may designate.
SECTION 55. CORPORATE FUNDS AND CHECKS. The funds of the Corporation shall be kept in such depositories as shall from time to time be
prescribed by the Board. All checks or other orders for the payment of money shall be signed by the Chief Executive Officer, President or Chief Financial Officer
or such other person or agent as may from time to time be authorized and with such countersignature, if any, as may be required by the Board.
SECTION 56. CONTRACTS AND OTHER DOCUMENTS. The Chief Executive Officer or President, or such other officer or officers as may from time to
time be authorized by the Board, shall have power to sign and execute on behalf of the Corporation deeds, conveyances and contracts, and any and all other
documents requiring execution by the Corporation. (Del. Code Ann., tit. 8, §§ 103(a), 142(a), 158).
SECTION 57. OWNERSHIP OF STOCK OF ANOTHER CORPORATION. The Chief Executive Officer or President, or such other officer or agent as
shall be authorized by the Board, shall have the power and authority, on behalf of the Corporation, to attend and to vote at any meeting of stockholders of any
corporation in which the Corporation holds stock and may exercise, on behalf of the Corporation, any and all of the rights and powers
incident to the ownership of such stock at any such meeting, including the authority to execute and deliver proxies and consents on behalf of the Corporation. (Del.
Code Ann., tit. 8, § 123).
SECTION 58. SEVERABILITY. If any provision of these Bylaws is illegal or unenforceable as such, such illegality or unenforceability shall not affect any
other provision of these Bylaws and such other provisions shall continue in full force and effect.
SECTION 59. SUBJECT TO LAW AND THE CERTIFICATE OF INCORPORATION. All rights, powers, duties and responsibilities provided for in these
Bylaws, whether or not explicitly so qualified, are qualified by the provisions of the Certificate, the DGCL and any other applicable law. (Del. Code Ann., tit. 8, §
109(b)).
SECTION 60. EMERGENCY BYLAWS. The provisions of this Section 60 shall be operative only during a national emergency declared by the President of
the United States or the person performing the President’s functions, or in the event of a nuclear, atomic or other attack on the United States or a disaster or
catastrophe making it impossible or impracticable for the Corporation to conduct its business without recourse to the provisions of this Section 60. Said provisions
in such event shall override all other Bylaws or the Corporation in conflict with any provisions of this Section 60, and shall remain operative so long as it remains
impossible or impracticable to continue the business of the Corporation otherwise, but thereafter shall be inoperative; provided , however , that all actions taken in
good faith pursuant to such provisions shall thereafter remain in full force and effect unless and until revoked by action taken pursuant to the provisions of the
Bylaws other than those contained in this Section 60 (Del. Code Ann., tit. 8, § 110).
(a) A meeting of the Board or of any committee thereof may be called by any officer or director upon one hour’s notice to all persons entitled to notice
whom, in the sole judgment of the notifier, it is feasible to notify;
(b) The director or directors in attendance at the meeting of the Board or of any committee thereof shall constitute a quorum; and
(c) These Bylaws may be amended or repealed, in whole or in part, by a majority vote of the directors attending any meeting of the Board, provided such
amendment or repeal shall only be effective for the duration of such emergency.
ARTICLE IX
INDEMNIFICATION
SECTION 61. RIGHT TO INDEMNIFICATION. The Corporation shall indemnify and hold harmless, to the fullest extent permitted by applicable law as it
presently exists or may hereafter be amended, any person who was or is made or is threatened to be made a party or is otherwise involved in any action, suit or
proceeding, whether civil, criminal, administrative or investigative (a “ proceeding ”) by reason of the fact that he, or a person for whom he is the legal
representative, is or was a director or officer of the Corporation or is or was serving at the request of the Corporation as a director, officer, employee or agent of
another corporation or of a partnership, joint venture, trust, enterprise or nonprofit entity, including service with respect to employee benefit plans, against all
liability and loss suffered and expenses (including attorneys’ fees) reasonably incurred by such person; provided , however , that the Corporation shall not be
required to indemnify any director or executive officer in connection with any proceeding (or part thereof) initiated by such person or any proceeding by such
person against the Corporation or its directors, officers, employees or other agents unless (i) such indemnification is expressly required to be made by applicable
law, (ii) the proceeding was authorized by the Board, (iii) such indemnification is provided by the Corporation, in its sole discretion, or (iv) such indemnification is
required to be made under Section 63, pursuant to the powers vested in the Corporation under the DGCL or any other applicable law. (Del. Code Ann., tit. 8, §
145).
SECTION 62. ADVANCEMENT OF EXPENSES.
(a) The Corporation shall advance to any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action,
suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that he is or was a director or executive officer, of the Corporation,
or is or was
serving at the request of the Corporation as a director or executive officer of another corporation, partnership, joint venture, trust or other enterprise, prior to the
final disposition of the proceeding, promptly following request therefor, all expenses incurred by any director or executive officer in connection with such
proceeding, provided , however , that if the DGCL requires, an advancement of expenses incurred by a director or executive officer in his or her capacity as a
director or executive officer (and not in any other capacity in which service was or is rendered by such indemnitee, including, without limitation, service to an
employee benefit plan) shall be made only upon delivery to the Corporation of an undertaking (hereinafter, an “ undertaking ”), by or on behalf of such indemnitee,
to repay all amounts so advanced if it shall ultimately be determined by final judicial decision from which there is no further right to appeal (hereinafter a “final
adjudication”) that such indemnitee is not entitled to be indemnified for such expenses under this Section 62 or otherwise. (Del. Code Ann., tit. 8, § 145(e)).
(b) Notwithstanding the foregoing, unless otherwise determined pursuant to Section 63, no advance shall be made by the Corporation to an executive officer
of the Corporation (except by reason of the fact that such executive officer is or was a director of the Corporation in which event this paragraph shall not apply) in
any action, suit or proceeding, whether civil, criminal, administrative or investigative, if a determination is reasonably and promptly made (i) by a majority vote of
directors who were not parties to the proceeding, even if not a quorum, or (ii) by a committee of such directors designated by a majority vote of such directors,
even though less than a quorum, or (iii) if there are no such directors, or such directors so direct, by independent legal counsel in a written opinion, that the facts
known to the decision-making party at the time such determination is made demonstrate clearly and convincingly that such person acted in bad faith or in a manner
that such person did not believe to be in or not opposed to the best interests of the Corporation. (Del. Code Ann., tit. 8, § 145(e)).
SECTION 63. ENFORCEMENT. Without the necessity of entering into an express contract, all rights to indemnification and advances to directors and
executive officers under this Article IX shall be deemed to be contractual rights and be effective to the same extent and as if provided for in a contract between the
Corporation and the director or executive officer. Any right to indemnification or advances granted by this Article IX to a director or executive officer shall be
enforceable by or on behalf of the person holding such right in any court of competent jurisdiction if (i) the claim for indemnification or advances is denied, in
whole or in part, or (ii) no disposition of such claim is made within sixty (60) days of request therefor. The claimant in such enforcement action, if successful in
whole or in part, shall be entitled to be paid also the expense of prosecuting the claim. In connection with any claim for indemnification, the Corporation shall be
entitled to raise as a defense to any such action that the claimant has not met the standards of conduct that make it permissible under the DGCL or any other
applicable law for the Corporation to indemnify the claimant for the amount claimed. In connection with any claim by an executive officer of the Corporation
(except in any action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that such executive officer is or was a
director of the Corporation) for advances, the Corporation shall be entitled to raise a defense as to any such action clear and convincing evidence that such person
acted in bad faith or in a manner that such person did not believe to be in or not opposed to the best interests of the Corporation, or with respect to any criminal
action or proceeding that such person acted without reasonable cause to believe that his conduct was lawful. Neither the failure of the Corporation (including its
Board, independent legal counsel or its stockholders) to have made a determination prior to the commencement of such action that indemnification of the claimant
is proper in the circumstances because he has met the applicable standard of conduct set forth in the DGCL or any other applicable law, nor an actual determination
by the Corporation (including its Board, independent legal counsel or its stockholders) that the claimant has not met such applicable standard of conduct, shall be a
defense to the action or create a presumption that claimant has not met the applicable standard of conduct. In any suit brought by a director or executive officer to
enforce a right to indemnification or to an advancement of expenses hereunder, the burden of proving that the director or executive officer is not entitled to be
indemnified, or to such advancement of expenses, under this Article IX or otherwise shall be on the Corporation. (Del. Code Ann., tit. 8, § 145(k)).
SECTION 64. GOOD FAITH.
(a) For purposes of any determination under this Article IX, a director or executive officer shall be deemed to have acted in good faith and in a manner he
reasonably believed to be in or not opposed to the best interests of the Corporation, and, with respect to any criminal action or proceeding, to have had no
reasonable cause to believe that his conduct was unlawful, if his action is based on information, opinions, reports and statements, including financial statements
and other financial data, in each case prepared or presented by:
(i) one or more officers or employees of the Corporation whom the director or executive officer believed to be reliable and competent in the matters
presented;
(ii) counsel, independent accountants or other persons as to matters which the director or executive officer believed to be within such person’s
professional competence; and
(iii) with respect to a Director, a committee of the Board upon which such director does not serve, as to matters within such Committee’s designated
authority, which committee the director believes to merit confidence; so long as, in each case, the director or executive officer acts without knowledge that would
cause such reliance to be unwarranted.
(b) The termination of any proceeding by judgment, order, settlement, conviction or upon a plea of nolo contendere or its equivalent shall not, of itself,
create a presumption that the person did not act in good faith and in a manner which he reasonably believed to be in or not opposed to the best interests of the
Corporation, and, with respect to any criminal proceeding, that he had reasonable cause to believe that his conduct was unlawful.
(c) The provisions of this Article IX shall not be deemed to be exclusive or to limit in any way the circumstances in which a person may be deemed to have
met the applicable standard of conduct set forth by the DGCL.
SECTION 65. NON-EXCLUSIVITY OF RIGHTS. The rights conferred on any person by this Article IX shall not be exclusive of any other rights which
such person may have or hereafter acquire under any statute, provision of the Certificate, these Bylaws, agreement, vote of stockholders or disinterested directors
or otherwise, both as to action in his official capacity and as to action in another capacity while holding office. The Corporation is specifically authorized to enter
into individual contracts with any or all of its directors, officers, employees or agents respecting indemnification and advances, to the fullest extent not prohibited
by the DGCL, or by any other applicable law. (Del. Code Ann., tit. 8, § 145(f)).
SECTION 66. OTHER INDEMNIFICATION. The Corporation’s obligation, if any, to indemnify any person who was or is serving at its request as a
director, officer, employee or agent of another corporation, partnership, joint venture, trust, enterprise or nonprofit entity shall be reduced by any amount such
person may collect as indemnification from such other corporation, partnership, joint venture, trust, enterprise or nonprofit enterprise.
SECTION 67. INSURANCE. The Board may authorize, by a vote of a majority of a quorum of the Board, the Corporation to purchase and maintain
insurance on behalf of any person who is or was a director, officer, employee or agent of the Corporation, or is or was serving at the request of the Corporation as a
director, officer, member, employee or agent of another corporation, partnership, joint venture, trust, employee benefit plan or other enterprise against any liability
asserted against him and incurred by him in any such capacity, or arising out of his status as such, whether or not the Corporation would have the power to
indemnify him against such liability under the provisions of this Article IX or of the DGCL; and the Corporation may create a trust fund, grant a security interest
and/or use other means (including, without limitation, letters of credit, surety bonds and/or other similar arrangements) to the full extent authorized or permitted by
the DGCL and other applicable law to ensure the payment of such amounts as may become necessary to effect the indemnification as provided in this Article IX or
elsewhere. (Del. Code Ann., tit. 8, § 145(g)).
SECTION 68. DEFINITIONS. For the purposes of this Article IX, the following definition shall apply:
(a) The term “ Corporation ” shall include, in addition to the resulting corporation, any constituent corporation (including any constituent of a constituent)
absorbed in a consolidation or merger which, if its separate existence had continued, would have had power and authority to indemnify its directors, officers and
employees or agents, so that any person who is or was a director, officer, employee or agent of such constituent corporation, or is or was serving at the request of
such constituent corporation as a director, officer, member, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, shall
stand in the same position under the provisions of this Article IX with respect to the resulting or surviving corporation as he would have with respect to such
constituent corporation if its separate existence had continued. (Del. Code Ann., tit. 8, § 145(h)).
(b) The term “ other enterprises ” shall include employee benefit plans (Del. Code Ann., tit. 8, § 145(i));
(c) The term “ fines ” shall include any excise taxes assessed on a person with respect to any employee benefit plan (Del. Code Ann., tit. 8, § 145(i));
(d) References to “ serving at the request of the Corporation ” shall include any service as a director, officer, employee or agent of the Corporation which
imposes duties on, or involves services by, such director, officer, employee, or agent with respect to an employee benefit plan, its participants or beneficiaries (Del.
Code Ann., tit. 8, § 145(i)); and
(e) A person who acted in good faith and in a manner he reasonably believed to be in the interest of the participants and beneficiaries of an employee benefit
plan shall be deemed to have acted in a manner “ not opposed to the best interests of the Corporation ” as referred to in this Article IX. (Del. Code Ann., tit. 8, §
145(i)).
SECTION 69. LIABILITY OF DIRECTORS. No director of the Corporation shall be personally liable to the Corporation or its stockholders for monetary
damages for breach of fiduciary duty as a director; provided , however , that this, limitation of liability shall not eliminate or limit the liabilities of the directors for
any breach of the director’s duty of loyalty to the Corporation or its stockholders, for acts or omissions not in good faith or which involve intentional misconduct or
a knowing violation of law, under Section 174 of the DGCL, or for any transaction from which the director derived an improper personal benefit; provided , further
, that this limitation of liability shall not eliminate or limit the liability of a director for any act or omission occurring prior to the adoption of these Bylaws.
SECTION 70. SURVIVAL OF RIGHTS. The rights conferred on any person by this Article IX shall continue as to a person who has ceased to be a director,
executive officer, officer, employee or other agent and shall inure to the benefit of the heirs, executors and administrators of such a person. (Del. Code Ann., tit. 8,
§ 145(j)).
SECTION 71. SAVINGS CLAUSE. If this Article IX or any portion hereof shall be invalidated on any ground by any court of competent jurisdiction, then
the Corporation shall nevertheless indemnify each director and executive officer to the full extent not prohibited by any applicable portion of this Article IX that
shall not have been invalidated, or by any other applicable law. If this Article IX shall be invalid due to the application of the indemnification provisions of another
jurisdiction, then the Corporation shall indemnify each director and executive officer to the full extent under any other applicable law.
SECTION 72. AMENDMENT OR REPEAL. Any repeal or modification of the provisions of this Article IX shall only be prospective and shall not
adversely affect any right or protection hereunder of any person in respect of any act or omission occurring prior to the time of such repeal or modification.
Exhibit 10.19
December 19, 2016
J. Kevin Buchi
Re: Interim President and Chief Executive Officer Agreement
Dear Kevin:
On behalf of Impax Laboratories, Inc. (the “ Company ”), I am pleased to offer you the position of Interim President and
Chief Executive Officer of the Company (“ Interim Chief Executive Officer ”) on the terms and conditions set forth in this letter
agreement (this “ Agreement ”). You have agreed to accept this role while we engage in a search for a permanent President and
Chief Executive Officer. While acting as Interim Chief Executive Officer, you will also continue to serve as a member of the Board
of Directors of the Company (the “ Board ”). You may accept this Agreement by signing and returning a copy of this Agreement to
the Company as provided below.
1. Term of Agreement. Your services as Interim Chief Executive Officer under this Agreement shall commence as of
December 19, 2016 (the “ Start Date ”), and, subject to Section 6 hereof, your service as Interim Chief Executive Officer shall
continue until the earliest to occur of: (i) the appointment of a permanent President and Chief Executive Officer, or (ii) your
resignation from this position or the termination of your service by us (the date of the earliest to occur, the “ Separation Date ”).
Your termination of employment as Interim Chief Executive Officer will not affect your service on the Board, which will remain
subject to the Company’s bylaws.
2. Position and Duties. During the term of this Agreement, you shall serve as Interim Chief Executive Officer of the
Company. Your duties and authority as Interim Chief Executive Officer shall be prescribed by the Board and shall be commensurate
with those of a chief executive officer of a company of comparable size and with a similar business as the Company. You agree that
while serving as Interim Chief Executive Officer under this Agreement you shall use best efforts and devote such business time to
the Company as reasonably necessary to manage the business as the Company searches for a permanent President and Chief
Executive Officer.
3. Status. Your status with respect to the services you perform under this Agreement shall be as an employee of the
Company. The Company shall be entitled to withhold from any amounts payable under this Agreement any federal, state, or local
withholding or other taxes, deductions or charges which the Company is required to withhold.
4. Compensation and Benefits. In consideration for your services to the Company as Interim Chief Executive Officer, you
shall receive the following compensation and benefits from the Company.
(a) Salary. During the period of time commencing on the Start Date and ending on the Separation Date (the “
Employment Period ”), the Company shall pay you a salary of $10,000 per week, which is equivalent to $520,000 per annum (as
may be adjusted from time to time, the “ Salary ”), subject to required withholding and authorized deductions and payable in
accordance with the Company’s standard payroll procedures for executives (currently, bi-weekly). You acknowledge and agree that
during the Employment Period, your only compensation will consist of the Salary, and you will not be entitled to any additional fees
or other compensation for serving as a member of the Board, provided, that the equity awards granted to you in connection with the
commencement of your service as a member of the Board will continue to vest based on your service hereunder. Following the
Employment Period, in the event you continue to serve as a member of the Board, you will receive fees and equity grants in
accordance with the Company’s policy for non-employee members of the Board.
(b) Benefits. You will be entitled to participate in or receive benefits under the employee benefit plans made
available by the Company to its executive-level employees subject to, and on a basis consistent with, the terms, conditions and
overall administration of such plans. You will be eligible to accrue personal time off (“ PTO ”) at the rate of 20 days per year,
subject to, and in accordance with, the Company’s PTO policies applicable to Company executives. The Company reserves its right
to alter or amend its benefit plans and programs at any time. For the avoidance of doubt, you will not be entitled to participate in the
Company’s equity incentive program while employed hereunder.
(c) Expenses . The Company shall reimburse you for business expenses that are reasonable and necessary for you to
perform, and were incurred by you in the course of the performance of your duties pursuant to this Agreement and in accordance
with the Company’s general policies, including, reasonable travel between your home and the Company’s principal offices in New
Jersey and California. Such expenses shall be reimbursed upon your submission of vouchers and an expense report in such form as
may be required by the Company consistent with the Company’s policies in place from time-to-time.
5. Confidentiality. In connection with your employment hereunder, you must enter into the Company’s standard Employee
Invention and Proprietary Information Agreement (the “ Confidentiality Agreement ”).
6. Termination. This Agreement may be terminated by you at any time for any or no reason upon reasonable notice to the
Company in order to facilitate an orderly transition of your duties. This Agreement may be terminated by the Company at any time
for any or no reason.
7. Miscellaneous.
(a) This Agreement, together with the Confidentiality Agreement, constitutes the complete, final and exclusive
embodiment of the entire agreement between you and the Company with regard to the subject matter hereof. This Agreement is
entered into without reliance on any promise or representation, written or oral, other than those expressly contained herein, and this
Agreement supersedes any other such promises, warranties or representations and any other written or oral statements concerning
your rights to any compensation, equity or benefits from the Company, its predecessors or successors in interest.
(b) This Agreement may not be modified or amended except in a writing signed by both you and a duly authorized
officer of the Company.
(c) This Agreement may be signed in counterparts and the counterparts taken together shall constitute one agreement.
(d) This Agreement shall be deemed to have been entered into and shall be construed and enforced in accordance
with the laws of the State of California as applied to contracts made and to be performed entirely within California.
(Signature Page Follows)
If this Agreement is acceptable to you, please sign below and return the original, fully executed Agreement to the Company.
Sincerely,
IMPAX LABORATORIES, INC.
By: /s/ Robert L. Burr
Robert L. Burr
Chairman of the Board of Directors
AGREED AND ACCEPTED:
/s/ J. Kevin Buchi 12/19/2016
J. Kevin Buchi Date
General Release and Waiver
Exhibit 10.20.2
This General Release and Waiver (this “ Release ”) is entered into on December 19, 2016 by G. Frederick Wilkinson (the “
Executive ”), on the one hand, and Impax Laboratories, Inc. and its subsidiaries and affiliates (collectively, the “ Company ”), on
the other hand (the Executive and the Company are referred to collectively as the “ Parties ”). Defined terms used but not defined
herein shall have the same meaning as set forth in the Employment Agreement between the Executive and the Company dated April
21, 2014 (“ Employment Agreement ”).
1.
Confirmation of Employment Separation . The Executive’s employment with the Company is terminated as of
December 19, 2016 (the “ Separation Date ”). This Release sets forth the payments, benefits, and other terms and conditions that
the Company will provide to the Executive under, and serves as notice of, an election by the Company of a termination pursuant to
Section 4.1.6 of the Employment Agreement. If the Executive executes, delivers, and does not revoke this Release as set forth in
Section 12 below, the Executive will be entitled to the payments and benefits pursuant to the terms hereof. Except as set forth in this
Release, the Executive acknowledges and agrees that the Separation Date is the date of the end of his employment for all purposes,
including for purposes of participation in and coverage under all benefit plans and programs sponsored by or through the Company.
The Executive acknowledges and agrees that the Company shall not have any obligation to rehire the Executive, nor shall the
Company have any obligation to consider him for employment after the Separation Date. The Executive acknowledges and agrees
that he will not knowingly seek employment with the Company at any time in the future, and that the Company’s refusal to employ
the Executive in any future capacity will not subject the Company to liability on any grounds.
2.
Separation . Effective as of the Separation Date, the Executive has been notified of his termination under Section
4.1.6 and, as a result, hereby resigns as an officer and director of the Company and all of its subsidiaries and affiliates and from any
positions held with any other entities at the direction or request of the Company. The Executive agrees to promptly execute and
deliver such other documents as the Company shall reasonably request to evidence such resignations. In addition, the Executive
acknowledges and agrees that the Separation Date shall be the date of his termination from all other offices, positions, trusteeships,
committee memberships and fiduciary capacities held with, or on behalf of, the Company. The Executive agrees to make himself
available to assist and consult with the Company regarding matters relating to his former duties for a period of twenty-four (24)
months after his Separation Date, provided that (i) the Executive is reimbursed for any and all reasonable expenses related to such
cooperation, including but not limited to, travel, lodging, communication, and duplication expenses,(ii) the Executive is reimbursed
for reasonable attorney fees if the Executive in good faith believes that separate legal representation is required, and (iii) the
Executive is compensated for the Executive’s time at a rate equivalent to the Executive’s most recent base salary. For the avoidance
of doubt, services provided by the Executive under this Section 2 shall not constitute continued service for the purposes of the
Executive’s outstanding equity awards which shall be treated in all respects in accordance with Section 3(e) hereof. The Executive’s
receipt of any compensation and/or reimbursement related to his assistance and consulting as set forth herein shall be separate from,
and shall not reduce, the Separation Benefits described in Section 3 below.
3.
Separation Benefits . The Executive will be entitled to the Amounts and Benefits upon the Separation Date
regardless of whether or not the Release is executed, delivered, revoked or otherwise. In addition, subject to the Executive not
revoking this Release prior to the Release Effective Date, the
Executive will be entitled, subject to the terms and conditions set forth below, to the payments and benefits set forth in this Section
3 (collectively, the “ Separation Benefits ”), which together satisfy in full the Company’s obligations with respect to payments and
benefits under the Employment Agreement or otherwise:
a.
Separation Pay : The Company shall pay the Executive $1,829,880.00 (representing two (2) times the Executive’s
Base Salary (as defined in Section 2.1 of the Employment Agreement)), paid in installments on the Company’s normal payroll dates
for a period of 12 consecutive months in accordance with Exhibit A hereof, which is incorporated herein by reference, with a
schedule that complies with, or is exempt from, IRS Code § 409A, and with each payment deemed to be a separate payment for
purposes of IRS Code §409A.
b.
Separation Bonus : The Company shall pay the Executive $1,967,793.00 (representing two (2) times the average of
the Incentive Bonus (as defined in Section 2.2 of the Employment Agreement) the Executive received from the Company for all
fiscal years completed during the term of the Employment Agreement), paid in installments on the Company’s normal payroll dates
for a period of 12 consecutive months in accordance with Exhibit A , with a schedule that complies with, or is exempt from, IRS
Code § 409A, and with each payment deemed to be a separate payment for purposes of IRS Code §409A.
c.
Pro Rata Bonus : No later than March 15, 2017, the Company shall pay the Executive a pro rata portion of the
Executive’s Incentive Bonus for fiscal year 2016 based solely on the Company’s actual results against the Company’s goals for the
year (determined by multiplying the amount of such Incentive Bonus which would be due for the full fiscal year, as determined in
good faith by the Board, by a fraction, the numerator of which is the number of days up to the Separation Date during 2016 that the
Executive was employed by the Company and the denominator of which is 365).
d. Benefits
i. Medical Benefits : The Company will timely provide the Executive with information regarding eligibility to
continue medical, dental, and vision benefits under the Consolidated Omnibus Budget Reconciliation Act, as amended (“ COBRA
”), in accordance with its terms. If the Executive timely and effectively elects under COBRA to continue medical benefit coverage
after the Separation Date under the Company Independence Blue Cross medical plan (or any successor plan) for himself or any of
his dependents currently enrolled on his plan (the “ Dependents ”), then the Company will pay the insurer such COBRA medical
benefit premiums for as long as the Executive and/or his Dependents remain eligible for and enrolled under COBRA for up to
twenty-four (24) consecutive months commencing immediately after the Separation Date. In the event the Executive or his
Dependents, after timely and effectively electing to continue such medical benefit coverage under COBRA, and after using all
available COBRA, become ineligible to continue such medical benefit coverage under COBRA through no fault of their own, the
Executive and/or his Dependents (but only if they would be eligible to obtain coverage under the Company Independence Blue
Cross medical plan had the Executive been employed by the Company at such time), as applicable, may be eligible to convert to an
individual Independence Blue Cross Individual Personal Choice medical plan (or any successor plan as set forth in the then
applicable group medical plan documents) with comparable medical benefit coverage to that coverage applicable as of immediately
prior to such ineligibility. In such event, the Company agrees to pay the insurer the premium for such individual plan for the period
commencing from such COBRA ineligibility date and ending on the last day of the 24-month period commencing immediately after
the Separation Date.
ii.
Dental Benefits : The Executive will remain eligible to continue dental benefit coverage under the
Company Delta Dental dental plan (or any successor plan) for himself and his Dependents for up to 24 consecutive months
commencing immediately after the Separation Date. The Company will pay the insurer for any related dental benefit premiums
under such group dental plan for as long as the Executive and/or his Dependents remain enrolled in such group dental benefit plan,
for up to 24 consecutive months commencing immediately after the Separation Date.
iii.
Vision Benefits : The Executive will remain eligible to continue vision benefit coverage under the
Company VSP vision plan (or any successor plan) for himself and his Dependents for up to 24 consecutive months commencing
immediately after the Separation Date. The Company will pay the insurer for any related vision benefit premiums under such vision
plan for as long as the Executive and/or his Dependents remain enrolled in such group vision benefit plan, for up to 24 consecutive
months commencing immediately after the Separation Date.
iv.
Payment for Benefit Continuation . If it is not possible or convenient for the Company to pay the
insurer directly for any medical, dental, or vision insurance benefit coverage set forth in Sections 3(d) hereunder, the Company will
give the Executive sufficient written notice in accordance with the provisions herein to permit the Executive to timely make such
payments and the Company will pay the Executive within 30 days of receipt from the Executive of reasonable proof that payment
has been timely made by him an amount equal to the amount necessary to reimburse and make the Executive whole for such
payments on an after-tax basis (taking into account any tax consequences associated with the receipt of such payments and
additional amounts). The Executive agrees to notify the Company promptly in writing after the Executive or his Dependents enroll in
medical, dental or vision insurance benefits under another employer’s plan, in which case any obligation by the Company under this
Section 3 or otherwise to extend such benefit(s) shall cease immediately.
e.
Stock Option and Restricted Stock Awards : Subject to the Release becoming irrevocable in accordance with
Section 12 below, (i) there shall be a 12 month acceleration of vesting for those stock options and shares of restricted stock described
in Table 1 of Exhibit B hereof (and, accordingly, the restricted stock and stock options described therein shall immediately become
vested and/or exercisable, and all forfeiture restrictions shall lapse, as of the Release Effective Date), and (ii) the Executive shall be
entitled to exercise his vested stock options during the 12 month period immediately following the Release Effective Date (or, if
earlier, the expiration of such stock options pursuant to their terms). Each of these stock options and shares of restricted stock shall
otherwise remain subject in all respects to the restrictions of the applicable stock option grant or stock bonus award agreements
between the Executive and the Company and the Amended and Restated 2002 Equity Incentive Plan. Except as set forth in this
Section 3(e) and Exhibit B , all other stock options and shares of restricted stock held by the Executive that are unvested as of the
Release Effective Date shall terminate and be forfeited.
f.
Subject to Section 3(e) above, any changes to the terms and conditions of the Company’s benefit plans that apply
generally to employees and that are permissible without consent of such employees generally shall also apply to the Executive and
his entitlement under this Release (e.g., changes to the premiums, changes to coverage, changes in insurers, changes to the equity
incentive plans, etc.).
g.
Notwithstanding any other provision of this Release or the Employment Agreement, the Executive acknowledges
and agrees that the Separation Benefits set forth in this Section 3 together with the Amounts and Benefits (as defined in Section 4.4.1
of the Employment Agreement), are the sole wages, payments, stock, stock options, insurance, and benefits to which the Executive
is entitled, under the Employment Agreement or otherwise, and that no other wages, payments, stock, stock options, insurance,
benefits or other monies of any nature are due from the Company. The Executive acknowledges and agrees that the Separation
Benefits exceed any wages, payment, stock, stock options, insurance, benefit, or other thing of value to which the Executive might
otherwise be entitled under any policy, plan or procedure of the Company and/or any other agreement between the Executive and the
Company.
h.
All payments made to the Executive pursuant to this Section 3 shall be subject to all applicable or required
deductions, taxes, and withholdings as determined by the Company in consultation with the Executive.
4.
Tax Liability . Although the Company shall make applicable tax withholdings from the Separation Benefits and the
Amounts and Benefits, the Executive acknowledges and agrees that, except as otherwise provided herein, any and all tax liability,
penalties and interest (including under Code Section 409A) which may become due from the Executive or assessed against the
Executive because of the Separation Benefits or Amounts and Benefits, and/or any other payments or benefits referenced in this
Release are the Executive’s sole responsibility.
5.
General Release and Waiver . In consideration of the Separation Benefits and/or any other payments or benefits
referenced in this Release, and for other good and valuable consideration, receipt of which is hereby acknowledged, the Executive
for himself and for his heirs, executors, administrators, trustees, legal representatives and assigns (collectively, the “ Releasors ”),
hereby releases, remises, and acquits the Company and its subsidiaries and affiliates and all of their respective past, present and
future parent entities, subsidiaries, divisions, affiliates and related business entities, any of their successors and assigns, assets,
employee benefit plans or funds, and any of their respective past and/or present directors, officers, fiduciaries, agents, trustees,
administrators, managers, supervisors, shareholders, investors, employees, legal representatives, agents, counsel and assigns,
whether acting on behalf of the Company or its subsidiaries or affiliates or, in their individual capacities (collectively, the “
Releasees ” and each a “ Releasee ”) from any and all claims, known or unknown, which the Releasors have or may have against
any Releasee arising on or prior to the date that the Executive executes this Release and any and all liability which any such
Releasee may have to the Releasors, whether denominated claims, demands, causes of action, obligations, damages or liabilities
arising from any and all bases, however denominated, including but not limited to (a) any claim under the Age Discrimination in
Employment Act of 1967 (“ ADEA ”), the Americans with Disabilities Act of 1990, the Family and Medical Leave Act of 1993,
the Civil Rights Act of 1964, the Civil Rights Act of 1991, Section 1981 of the Civil Rights Act of 1866, the Equal Pay Act, the
Lilly Ledbetter Fair Pay Act, the Immigration Reform and Control Act of 1986, the Employee Retirement Income Security Act of
1974, (excluding claims for accrued, vested benefits under any employee benefit or pension plan of the Company, subject to the
terms and conditions of such plan and applicable law), the Uniform Trade Secrets Act, the Sarbanes-Oxley Act of 2002, the Fair
Labor Standards Act, all as amended; (b) any and all claims arising from or relating to the Executive’s employment relationship
with Company and his service relationship as an officer or director of the Company or any of its subsidiaries or affiliates, or as a
result of the termination of such relationships; (c) all claims related to the Executive’s compensation or benefits from the Company
or the Releasees, including salary, bonuses, commissions, vacation pay, expense reimbursements, severance pay, fringe benefits,
stock, stock options, or any other ownership interests in the Company or the Releasees; (d) all claims for breach of contract,
wrongful termination and breach of the implied covenant of good faith and fair dealing; (e) all tort claims, including claims for
fraud, defamation, privacy rights, emotional distress, and discharge in violation of public policy; and (f) all federal, state (including
but not limited to the States of Delaware, California, Pennsylvania and New Jersey), and local statutory or constitutional claims,
including claims for compensation, discrimination, harassment, whistleblower protection, retaliation, attorneys’ fees, costs,
disbursements, or other claims (referred to collectively as the “ Released
Claims ”). For the avoidance of doubt, Released Claims shall include all claims arising under the New Jersey Law Against
Discrimination, the New Jersey Conscientious Employee Protection Act, the New Jersey Family Leave Act, the New Jersey Wage
Payment Law, the New Jersey Wage and Hour Law, the New Jersey Equal Pay Act, and retaliation claims under the New Jersey
Workers’ Compensation Law.
Notwithstanding anything to the contrary in this Release or otherwise, this Release does not release claims that cannot be released as
a matter of law, or the right to file a charge with or participate in a charge by the Equal Employment Opportunity Commission (“
EEOC ”), or any other local, state, or federal administrative body or government agency that is authorized to enforce or administer
laws related to employment, against the Company. However, by executing this Release, the Executive hereby waives the right to
recover in any proceeding the Executive may bring before the EEOC or any state human rights commission or in any proceeding
brought by the EEOC or any state human rights commission on the Executive’s behalf. This Release is for any relief, no matter how
denominated, including, but not limited to, injunctive relief, wages, back pay, front pay, compensatory damages, or punitive
damages.
Notwithstanding anything to the contrary in this Release or otherwise, this Release shall not apply to (i) the Executive’s rights to
defense and indemnification from the Company, which rights shall never become less favorable to the Executive than they are at the
Separation Date, or rights, if any, to be covered under any applicable insurance policy with respect to any liability the Executive
incurred or might incur as an employee, officer or director of the Company including, without limitation, the Executive’s rights
under Section 7 of the Employment Agreement entitled Indemnification: Directors’ and Officers’ Liability Insurance; (ii) any right
the Executive may have to obtain contribution as permitted by law in the event of entry of judgment against the Executive as a result
of any act or failure to act for which the Executive, on the one hand, and Company or any other Releasee, on the other hand, are
jointly liable; (iii) any right of the Executive to pursue claims or actions in respect of the subject matter, rights or benefits
contemplated by this Release; and (iv) any claims or actions arising after the Separation Date.
The Executive waives and relinquishes all rights and benefits afforded by Section 1542 of the Civil Code of California, to the extent
applicable, which provides as follows:
A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR
SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF
KNOWN BY HIM OR HER MUST HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE
DEBTOR.
The Executive hereby acknowledges that the foregoing waiver is an essential and material term of this Release.
6.
Continuing Covenants . Notwithstanding any other provisions of this Release, the Executive acknowledges and
agrees that he remains subject to the provisions of Section 6 of the Employment Agreement and the Employee Invention and
Proprietary Information Agreement (“ Invention Agreement ”), both of which shall remain in full force and effect for the periods
set forth therein and are deemed part of this Release. The Executive acknowledges and agrees that he has made a diligent search for
any Company property in his possession or control and that he has returned or will return all such property to the Company. The
Executive acknowledges and agrees that any action for injunctive relief brought for claims arising out of Section 6 of the
Employment Agreement or the Invention Agreement, as well as any related claims for trade secret misappropriation, breach of
fiduciary duty, unfair competition, or other related business tort claims, shall be brought exclusively in Delaware state court or
Delaware federal court. The Executive shall submit to and accept the exclusive jurisdiction of such suit, legal action,
or proceeding in Delaware state court or Delaware federal court. The Executive acknowledges and agrees to accept personal
jurisdiction in Delaware and also acknowledges and agrees not to challenge the mandatory Delaware forum on any grounds
whatsoever, including lack of jurisdiction or forum non-conveniens .
The Company and the Executive hereby agree not to, directly or indirectly, defame, demean, criticize, disparage, communicate any
negative information about, make statements reasonably likely to be injurious to the other Party, or denigrate the name or reputation
of the other Party. Notwithstanding the foregoing, nothing in this Section shall prevent either Party from making any truthful
statement to the extent (i) necessary to rebut any untrue public statements made about them; (ii) necessary with respect to any
litigation, arbitration or mediation involving this Agreement and the enforcement thereof; or (iii) required by law or by any court,
arbitrator, mediator or administrative or legislative body (including any committee thereof) with jurisdiction over such person or
entity.
The Company and the Executive agree, upon the receipt of reasonable notice from the other Party, to cooperate, respond, provide
information and afford reasonable assistance to each other with regard to any claims, actions, investigations, interviews, audits or
matters that may arise on or after the Separation Date, to the extent that such claims, actions, investigations, interviews, audits or
matters relate to events occurring during the Executive’s period of employment with the Company, as well as events that predated or
post-date Executive’s employment that were existing during Executive’s employment with the Company. Any request for such
cooperation shall take into account the other party’s personal and business commitments. If the Executive is required to provide any
services pursuant to this Section, upon presentation of appropriate documentation, the Company shall promptly reimburse the
Executive for reasonable out-of-pocket travel, lodging, communication and duplication expenses incurred in connection with the
performance of such services and in accordance with the Company’s expense policy for its senior officers, for reasonable legal fees
and costs to the extent the Executive in good faith believes that separate legal representation is required, and for the Executive’s time
at a rate equivalent to the Executive’s most recent base salary. The Executive’s entitlement to reimbursement of such costs and
expenses, including legal fees, pursuant to this Section, shall in no way affect the Executive’s rights, if any, to be indemnified and/or
advanced fees and expenses to the fullest extent permitted by law or the Company’s corporate or other organizational documents,
any applicable insurance policy, and/or the Executive’s Employment Agreement.
7.
No Claims . The Executive acknowledges and agrees that there are no claims or actions currently filed or pending
relating to the subject matter of the Release, the Employment Agreement, or any Released Claims. The Executive acknowledges and
agrees that the Executive will not file or permit to be filed on the Executive’s behalf any such claims or actions. The Executive
hereby requests all administrative agencies having jurisdiction over employment and labor law matters and courts to honor the
Executive’s release of claims under this Release. Should the Company ever reasonably request the Executive to execute any
administrative dismissal forms related to the Released Claims, the Executive shall immediately execute the form and return it to the
Company. Should the Executive file any claim or action relating to the subject matter of this Release, the Employment Agreement,
or any Released Claims, such filing shall be considered an intentional breach of the Release and the Executive will be subject,
among other rights Company may have, to all damages and costs available under law and equity, including without limitation, the
amount of consideration paid hereunder. The Executive further acknowledges and agrees that the Executive has not failed to report
any work-related occupational injuries or diseases arising out of or in the course of employment with the Company. Notwithstanding
the foregoing, this Section 7 shall not, and shall be interpreted to not, apply to any claims or actions (i) excluded from Released
Claims in accordance with this Release, including Section 5 hereof, (ii) made to
enforce the provisions of this Release, or (iii) which may not permissibly be released pursuant to applicable law.
8.
No Admission . This Release does not constitute an admission of liability or wrongdoing of any kind by the
Company or any other Releasee. This Release is not intended, and shall not be construed, as an admission that any Releasee has
violated any federal, state or local law (statutory or decisional), ordinance or regulation, breached any contract or committed any
wrong whatsoever against any Releasor.
9.
Heirs and Assigns . The terms of this Release and the provision and payment of all Separation Benefits hereunder
shall be binding upon and inure to the benefit of the Parties named herein and their respective heirs, successors and permitted
assigns.
10.
Miscellaneous . This Release will be construed and enforced in accordance with the laws of the State of Delaware
without regard to the principles of conflicts of law. If any provision of this Release is held by a court of competent jurisdiction to be
illegal, void or unenforceable, such provision shall have no effect; however , the remaining provisions will be enforced to the
maximum extent possible. The Parties acknowledge and agree that, except as otherwise set forth herein, this Release constitutes the
entire agreement and complete understanding of the Parties with regard to the matters set forth herein and, except as otherwise set
forth in this Release, supersedes any and all agreements (including without limitation the Employment Agreement), understandings,
and discussions, whether written or oral, between the Parties. No other promises or agreements are binding unless in writing and
signed by each of the Parties after the Release Effective Date (as defined below). Should any provision of this Release require
interpretation or construction, it is agreed by the Parties that the entity interpreting or constructing this Release shall not apply a
presumption against one party by reason of the rule of construction that a document is to be construed more strictly against the Party
who prepared the document. The Parties agree to bear their own attorneys’ fees and costs with respect to this Release.
11.
Knowing and Voluntary Waiver . The Executive acknowledges and agrees that he: (a) has carefully read this
Release in its entirety; (b) has had an opportunity to consider it for at least 21 calendar days; (c) is hereby advised by the Company
in writing to consult with an attorney of his choosing in connection with this Release; (d) fully understands the significance of all of
the terms and conditions of this Release and has discussed them with his independent legal counsel, or had a reasonable opportunity
to do so; (e) has had answered to his satisfaction any questions he has asked with regard to the meaning and significance of any of
the provisions of this Release and has not relied on any statements or explanations made by any Releasee or their counsel; (f)
understands that he has seven calendar days in which to revoke this Release (as described in Section 12) after signing it and (g) is
signing this Release voluntarily and of his own free will and agrees to abide by all the terms and conditions contained herein.
12.
Effective Time of Release . The Executive may accept this Release by signing it and delivering it to the Company
as provided in Section 14 of this Release within 21 days of his receipt hereof. After executing this Release, the Executive will have
seven calendar days (the “ Revocation Period ”) to revoke this Release by indicating his desire to do so in writing delivered to the
Company as provided in Section 14 of this Release by no later than the last day of the Revocation Period. The effective date of this
Release shall be the eighth day after the Executive executes and delivers this Release (the “ Release Effective Date ”). If the last day
of the Revocation Period falls on a Saturday, Sunday or holiday, the last day of the Revocation Period will be deemed to be the next
business day. If the Executive does not execute this Release or exercises his right to revoke hereunder prior to the Release Effective
Date, he shall forfeit his right to receive any of the Separation Benefits set forth in Section 3 above and any other payments or
benefits referenced in this Release with the sole exception of the Amounts and Benefits, and
to the extent such Separation Benefits have already been provided, the Executive agrees that he will immediately reimburse the
Company for the amounts of such payment.
13.
Confidentiality . The provisions of this Release shall be treated as Confidential Information as that term is defined
in Section 6.1 of the Executive’s Employment Agreement.
14.
Notices . All notices or communications hereunder shall be in writing, and shall be addressed and delivered as
follows (or to such other address as either Party may have furnished to the other in writing by like notice): (a) To the Company:
Impax Laboratories, Inc., 31047 Genstar Road, Hayward, CA 94544, Attn: Senior Vice President and General Counsel; e-mail
Mark.Schlossberg@impaxlabs.com ; (b) To the Executive: G. Frederick Wilkinson, at the last home address and personal e-mail
address on file with the Company. All such notices and/or communications shall be conclusively deemed to be received and shall be
effective (i) if sent by hand delivery, upon receipt, (ii) if sent by telecopy or facsimile transmission, upon confirmation of receipt by
the sender of such transmission, (iii) if sent by overnight courier, one business day after being sent by overnight courier, (iv) if sent
via e-mail, on the date and time of receipt, or (v) if sent by registered or certified mail, postage prepaid, return receipt requested, on
the fifth day after the day on which such notice or correspondence is mailed. All payments shall be made so that the recipient shall
have immediately available US denominated funds on the due date for such payment, and shall be sent to the same addresses listed
above or as directed in writing by the Executive.
15.
Breach of Release . In the event that either Party is found in a final adjudication in accordance with the provisions
of this Release to have violated any of its obligations under this Release, the remedies, including injunctive relief and/or damages,
shall be determined by an arbitrator in accordance with the procedure set forth in Section 16. The Parties agree to bear their own
attorneys’ fees and costs with respect to this Release.
16.
Dispute Resolution . Except as otherwise set forth herein, the Parties hereby agree that any and all claims,
disputes, demands, or controversies of any nature whatsoever arising out of, or relating to, this Release, or its interpretation,
enforcement, breach, performance or execution, the Executive’s employment with the Company, or the termination of such
employment, including but not limited to any statutory claims, shall be resolved, to the fullest extent permitted by law, by final,
binding and confidential arbitration in Delaware (applying Delaware law) in accordance with the Employment Arbitration Rules and
Procedures of the American Arbitration Association then in effect. The decision of the arbitrator will be final and binding upon the
Parties. Judgment may be entered on the arbitrator’s award in any court having jurisdiction. The Parties acknowledge and agree that
in connection with any such arbitration and regardless of outcome: (a) each party shall bear its own costs and expenses, including
without limitation its own legal fees and expenses, and (b) joint expenses shall be born equally among the parties. EACH PARTY
WAIVES ITS RIGHT TO TRIAL BY JURY. Nothing in this Release is intended to prevent either the Executive or the Company
from obtaining injunctive relief in court to prevent irreparable harm pending the conclusion of any arbitration, including but not
limited to injunctive relief sought pursuant to Section 6 of this Release.
17.
Section 409A . It is the intention of the Parties that the payments and benefits to which the Executive could
become entitled pursuant to this Release, as well as the termination of the Executive’s employment, comply with or are exempt from
Section 409A of the Code. Any payments that qualify for the “short-term deferral” exception, the “separation pay” exception or
another exception under Section 409A of the Code shall be paid pursuant to the applicable exception. For purposes of the limitations
on nonqualified deferred compensation under Section 409A of the Code, each payment of compensation
under this Release shall be treated as a separate payment of compensation for purposes of Section 409A of the Code. In this regard,
notwithstanding anything in this Release to the contrary, all cash amounts (and cash equivalents) that become payable under Section
3 on account of the Executive’s termination of employment which is an “involuntary separation from service” (within the meaning
of Treasury Regulation Section 1.409A-1(n)) shall be paid as provided under Section 3 and, any such amounts qualifying for the
“short-term deferral” exception under Section 409A of the Code shall be paid no later than March 15 of the year following the year
in which the date of termination occurs (unless otherwise exempt from Section 409A of the Code). In the event the Parties determine
that the terms of this Release do not comply with Section 409A of the Code, they will negotiate reasonably and in good faith to
amend the terms of this Release such that they comply with, or are exempt from, Section 409A of the Code (in a manner that
attempts to minimize the economic impact of such amendment on the Executive and the Company) within the time period permitted
by the applicable Treasury Regulations and in accordance with IRS Notice 2010-6 and other applicable guidance. All expenses or
other reimbursements owed to the Executive under this Release shall be for expenses incurred during the Executive’s lifetime or
within ten years after his death, shall be payable in accordance with the Company’s policies in effect from time to time, but in any
event, to the extent required in order to comply with Section 409A of the Code, and shall be made on or prior to the last day of the
taxable year following the taxable year in which such expenses were incurred by the Executive. In addition, to the extent required in
order to comply with Section 409A of the Code, no such reimbursement or expenses eligible for reimbursement in any taxable year
shall in any way affect the expenses eligible for reimbursement in any other taxable year and the Executive’s right to reimbursement
or in-kind benefits shall not be subject to liquidation or exchanged for another benefit. Notwithstanding any other provision of this
Release, if (i) the Executive is to receive payments or benefits by reason of his separation from service (as such term is defined in
Section 409A of the Code) other than as a result of his death, (ii) the Executive is a “specified employee” within the meaning of
Section 409A of the Code (as determined in accordance with the methodology established by the Company as in effect on the date of
the Executive’s separation from service) for the period in which the payment or benefit would otherwise commence, and (iii) such
payment or benefit would otherwise subject the Executive to any tax, interest or penalty imposed under Section 409A of the Code
(or any regulation promulgated thereunder) if the payment or benefit would commence within six months of a termination of the
Executive’s employment, then such payment or benefit will instead be paid, with interest at the applicable federal rate provided for
in Section 7872(f)(2)(A) of the Code (“Interest”) determined as of the Separation Date, as provided below. Such payments or
benefits that would have otherwise been required to be made during such six-month period will be paid to the Executive (or his
estate, as the case may be) in one lump sum payment or otherwise provided to the Executive (or his estate, as the case may be) on the
earlier of (A) the first business day that is six months and one day after the Executive’s separation from service or (B) the fifth
business day following the Executive’s death. Thereafter, the payments and benefits will continue, if applicable, for the relevant
period set forth in this Release, as the case may be.
18.
Separate Counterparts. This Agreement may be executed in separate counterparts, none of which need contain the
signatures of all parties, each of which shall be deemed to be an original, and all of which taken together constitute one and the same
instrument. It shall not be necessary in making proof of this Agreement to produce or account for more than the number of
counterparts containing the respective signatures of, or on behalf of, all of the parties hereto. All executed signature pages
transmitted by facsimile or e-mail shall be deemed an original, and shall be binding.
[Signature Page Follows]
IN WITNESS WHEREOF, the Company has caused this Release to be duly executed and the Executive has hereunto set his hand, in
each case, as of the date indicated below.
Dated: December 19, 2016
Dated: December 19, 2016
/s/ G. Frederick Wilkinson
G. Frederick Wilkinson
/s/ Robert L. Burr
Robert L. Burr
Chairman of the Board of Directors
Impax Laboratories, Inc.
Subsidiaries of the Registrant as of the date of this report:
IMPAX LABORATORIES, INC.
Name of Subsidiary
Jurisdiction of Incorporation or Organization
Ownership
Exhibit 21.1
Amedra Pharmaceuticals LLC
Delaware
CorePharma, LLC
Impax Holdings LLC
Impax International Holdings, Inc.
New Jersey
Delaware
Delaware
Impax Laboratories Ireland Limited
Ireland
Impax Laboratories (Netherlands) B.V.
Netherlands
Impax Laboratories (Netherlands) C.V.
Netherlands
Impax Laboratories (Taiwan) Inc.
Taiwan, Republic of China
Impax Laboratories USA, LLC
Lineage Therapeutics Inc.
Mountain, LLC
California
Delaware
Delaware
Prohealth Biotech, Inc.
Taiwan, Republic of China
ThoRx Laboratories, Inc.
Tower Holdings, Inc.
Trail Services, Inc.
California
Delaware
Delaware
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
57.54%
100%
100%
100%
Consent of Independent Registered Public Accounting Firm
Exhibit 23.1
The Board of Directors
Impax Laboratories, Inc.:
We consent to the incorporation by reference in the Registration Statements (Nos. 333-158259, 333-168584, 333-189360, and 333-213677) on Form S-8 of Impax
Laboratories, Inc. of our report dated March 1, 2017, with respect to the consolidated balance sheets of Impax Laboratories, Inc. as of December 31, 2016 and
2015, and the related consolidated statements of operations, comprehensive (loss) income, changes in stockholders’ equity, and cash flows for each of the years in
the three-year period ended December 31, 2016, and the related financial statement schedule, and the effectiveness of internal control over financial reporting as of
December 31, 2016, which reports appear in the December 31, 2016 annual report on Form 10-K of Impax Laboratories, Inc.
/s/ KPMG LLP
Philadelphia, Pennsylvania
March 1, 2017
I, J. Kevin Buchi, certify that:
CERTIFICATION PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 31.1
1.
I have reviewed this Annual Report on Form 10-K for the fiscal year ended December 31, 2016 of Impax Laboratories, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control
over financial reporting.
March 1, 2017
By: /s/ J. Kevin Buchi
J. Kevin Buchi
Interim President and Chief Executive Officer
CERTIFICATION PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 31.2
I, Bryan M. Reasons, certify that:
1.
I have reviewed this Annual Report on Form 10-K for the fiscal year ended December 31, 2016 of Impax Laboratories, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control
over financial reporting.
March 1, 2017
By: /s/ Bryan M. Reasons
Bryan M. Reasons
Senior Vice President, Finance and
Chief Financial Officer
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.1
In connection with the Annual Report on Form 10-K of Impax Laboratories, Inc. (the “Company”) for the fiscal year ended December 31, 2016 (the “Report”), J.
Kevin Buchi, Interim President and Chief Executive Officer, hereby certifies, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Section 1350 of Chapter
63 of Title 18 of the United States Code), that:
(1)
the Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934; and
(2)
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
March 1, 2017
By: /s/ J. Kevin Buchi
J. Kevin Buchi
Interim President and Chief Executive Officer
The foregoing certification is being furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Section 1350 of Chapter 63 of Title 18 of the
United States Code) and is not being filed as part of the Report or as a separate disclosure document.
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.2
In connection with the Annual Report on Form 10-K of Impax Laboratories, Inc. (the “Company”) for the fiscal year ended December 31, 2016 (the “Report”),
Bryan M. Reasons., Senior Vice President, Finance, and Chief Financial Officer, hereby certifies, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(Section 1350 of Chapter 63 of Title 18 of the United States Code), that:
(1)
the Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934; and
(2)
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
March 1, 2017
By: /s/ Bryan M. Reasons
Bryan M. Reasons
Senior Vice President, Finance and
Chief Financial Officer
The foregoing certification is being furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Section 1350 of Chapter 63 of Title 18 of the
United States Code) and is not being filed as part of the Report or as a separate disclosure document.