PDL BioPharma, Inc.
932 Southwood Blvd.
Incline Village, NV 89451
Tel 775.832.8500
Fax 775.832.8501
Email ir@pdl.com
www.PDL.com
2019Annual Report
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
___________________________________________
FORM 10-K
___________________________________________
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2019
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: 000-19756
___________________________________________
PDL BioPharma, 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
94-3023969
932 Southwood Boulevard
Incline Village, Nevada 89451
(Address of principal executive offices)
Registrant’s telephone number, including area code
(775) 832-8500
___________________________________________
Securities registered pursuant to Section 12(b) of the Act:
Title of Class
Common Stock, par value $0.01 per share
Trading Symbol
PDLI
Name of 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
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
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
Indicate by check mark whether the registrant has submitted electronically 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
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation 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, a smaller reporting company, or emerging growth company. See the
definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
No
No
No
No
Large accelerated filer
Non-accelerated filer
Accelerated filer
Smaller reporting company
Emerging growth company
If an emerging growth company, indicated by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes
The aggregate market value of shares of common stock held by non-affiliates of the registrant, based on the closing sale price of a share of common stock on June 28, 2019 (the last
business day of the registrant’s most recently completed second fiscal quarter), as reported on the Nasdaq Global Select Market, was $354,547,520.
As of February 28, 2020, the registrant had outstanding 123,591,824 shares of common stock.
No
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s proxy statement to be delivered to stockholders with respect to the registrant’s 2020 Annual Meeting of Stockholders to be filed by the registrant with the U.S.
Securities and Exchange Commission are incorporated by reference into Part III of this Annual Report on Form 10-K. The registrant intends to file its proxy statement within 120 days
after its fiscal year end.
PDL BIOPHARMA, INC.
2019 Form 10-K Annual Report
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 Consolidated 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 Accountant Fees and Services ...................................................................................................
Item 15
Item 16
Exhibits and Financial Statement Schedules ............................................................................................
Form 10-K Summary ................................................................................................................................
SIGNATURES ................................................................................................................................................................
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53
54
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55
58
60
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78
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144
144
145
145
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Forward-looking Statements
PART I
This Annual Report contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than
statements of historical facts are “forward-looking statements” for purposes of these provisions, including any projections of
earnings, revenues or other financial items, any statements of the plans and objectives of management for future operations,
including any statements concerning the timing, implementation or success of our monetization strategy/plan of complete
liquidation, any statements regarding future economic conditions or performance, and any statement of assumptions underlying
any of the foregoing. These statements involve known and unknown risks, uncertainties and other important factors that may
cause our actual results, performance or achievements to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking statements. In some cases, forward-looking statements can be
identified by the use of terminology such as “may,” “will,” “intends,” “plans,” “believes,” “targets,” “anticipates,” “expects,”
“estimates,” “predicts,” “potential,” “continue” or “opportunity,” or the negative thereof or other comparable terminology. The
forward-looking statements in this Annual Report are only predictions. Although we believe that the expectations presented in the
forward-looking statements contained herein are reasonable at the time of filing, there can be no assurance that such expectations
or any of the forward-looking statements will prove to be correct. These forward-looking statements, including with regards to our
future financial condition and results of operations, are subject to inherent risks and uncertainties, including but not limited to the
risk factors set forth below, and for the reasons described elsewhere in this Annual Report. All forward-looking statements and
reasons why results may differ included in this Annual Report are made as of the date hereof. New risk factors and uncertainties
may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as
required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether
as a result of any new information, future events, changed circumstances or otherwise.
We own or have rights to certain trademarks, trade names, copyrights and other intellectual property used in our business,
including PDL BioPharma, Inc. and the PDL logo, each of which is considered a registered trademark. All other company names,
product names, trade names and trademarks included in this Annual Report are trademarks, registered trademarks or trade names
of their respective owners.
4
ITEM 1. BUSINESS
This section of the Company's Annual Report on Form 10-K has been superseded by the section titled “ITEM 1. BUSINESS” in
Exhibit 99.1 of the Form 8-K filed by the Company on June 30, 2020 and included in this 2019 Annual Report after the Annual
Report on Form 10-K. Please refer to the Form 8-K for this information.
5
ITEM 1A. RISK FACTORS
You should carefully consider and evaluate all of the information included and incorporated by reference in this Annual Report,
including the risk factors listed below. Any of these risks, as well as other risks and uncertainties, could materially and adversely
affect our business, results of operations and financial condition, which in turn could materially and adversely affect the trading
price of shares of our common stock. Additional risks not currently known or currently material to us may also harm our business.
We are exploring and evaluating potential transactions pursuant to our monetization strategy and plan of complete
liquidation and there can be no assurance that we will be successful in identifying or completing any potential transaction
or otherwise providing value to our stockholders or successfully implementing the strategy, that any such potential
transactions will yield significant value for stockholders or that the process will not have an adverse impact on our
business.
In September 2019, in an effort to enhance stockholder value, we commenced a review of strategic alternatives, including a
possible sale or liquidation of our company. In December 2019, we announced that we had completed the strategic review process
that we had initiated in September 2019 and that, as a result, we had decided to halt the execution of its growth strategy, cease
additional strategic investments and pursue a formal process that is intended to unlock value by monetizing the Company’s assets
and returning any available net proceeds to stockholders. We further announced in December 2019 that we would explore a
variety of potential transactions in connection with such monetization strategy, including a sale of our company, divestiture of our
assets or businesses, a spin-off transaction, a merger or a combination thereof. In February of 2020, the board of directors
approved, consistent with our monetization strategy, a plan of complete liquidation and passed a resolution to seek stockholder
approval to dissolve the Company under Delaware law at its next annual stockholder meeting. However, there can be no
assurance that the exploration of one or more potential monetization transactions will result in the identification or consummation
of any transaction, the period of time it will take to effect the strategy, or that we will be successful in implementing the strategy.
The success of our strategy will depend on our ability to identify and complete one or more transactions that will capture value for
our assets, and on numerous other factors, many of which are beyond our control. Such factors include market conditions,
industry trends, the interest of third parties in our business and assets and the availability of financing to potential buyers. Our
stock price or the value of net proceeds we are able to generate from the monetization process may be adversely affected if the
process is delayed, does not result in one or more successful transactions or if we are not able to execute the strategy. Even if one
or more transactions are completed, there can be no assurance that they will have a positive effect on stockholder value. Our
board of directors may determine to modify, amend or terminate the strategy at any time. If our board of directors were to so
determine, there could be a material adverse effect on our business, financial condition and results of operations, and we would
need to continue to operate our business and seek to grow it and create stockholder value.
In addition, our financial results and operations may be adversely affected by our monetization strategy and by the uncertainty
regarding its outcome. Management and our board of directors have been and will continue to focus on our monetization strategy
as well as on the continued operations of our business until such time, if any, that the monetization strategy has been successfully
executed or abandoned. Additionally, we have directed capital resources to the strategy that otherwise could have been used in our
business operations, and we expect to continue to do so until the process is completed or a determination is made that we will no
longer pursue the strategy. We expect to incur substantial expenses associated with identifying and evaluating potential
transactions, including those related to employee retention payments, equity compensation, severance pay, directors and officers
insurance, taxes, and legal, accounting and financial advisory fees. The process of exploring potential transactions is expected to
be time consuming and disruptive to our current business operations and, if we are unable to effectively manage the process, our
business, financial condition and results of operations would be adversely affected.
Furthermore, speculation regarding any developments related to the review of strategic alternatives and perceived uncertainties
related to the implementation of the monetization strategy could cause our stock price to fluctuate significantly.
We cannot assure you that we will be able to successfully implement our monetization strategy or that any transaction we may
enter into pursuant to the strategy would yield significant value for our stockholders. We also cannot assure you that any potential
transaction or other strategic alternative, if identified, evaluated and consummated, will provide greater value to our stockholders
than that reflected in the current stock price.
Our efforts to enhance stockholder value through our monetization strategy may not be successful.
We cannot assure you that our efforts to enhance stockholder value through the conduct of our monetization strategy will succeed.
There will be risks associated with any potential divestiture transaction, including whether we will attract potential acquirers for
26
the Company, its assets or its businesses, and whether offers made by such potential acquirors, if any, will be at valuations that we
deem reasonable. Moreover, we are not able to predict how long it will take to implement our monetization strategy. The timing
and terms of any transaction will depend on a variety of factors, many of which are beyond our control. A delay in, or failure to
complete, any such transaction could have a material effect on our stock price and the amount of any potential distributions to our
stockholders.
If we were to pursue a plan of dissolution, there can be no assurance as to the amount, if any, of cash or other property
that could be distributed to our stockholders or the timing of any such future distribution.
Assuming successful implementation of our monetization strategy and plan of complete liquidation, and an inability to sell the
Company as a whole, together with all or less than all of its assets, we expect to pursue a plan of dissolution as the most effective
mechanism for wind-down of the Company and resolution of outstanding claims. If such a plan of dissolution were to be
approved by our stockholders, once implemented through the filing of a Certificate of Dissolution and in accordance with
Delaware law, known liabilities would be paid or provided for, reserves would be established for contingent known and unknown
liabilities and any remaining assets would be monetized with net proceeds ultimately distributed to stockholders. The period for
claimants to file claims against the Company following the filing of a Certificate of Dissolution is set at three years by Delaware
statute. However, to the extent the Company is subject to pending litigation, the Company would potentially continue its existence
through the claims resolution process beyond the three-year period, with attendant expenses, until such litigation is resolved. After
the filing of a Certificate of Dissolution, it is possible that remaining assets not sold during the pre-dissolution period would be
monetized and net proceeds ultimately distributed, subject to the claims resolution process. We expect that we would have limited
or no new revenue generation sources or activities and that we would not engage in further business activities following the
adoption of a dissolution plan and the filing of a Certificate of Dissolution except for winding up our business, selling or
disposing of any of our remaining saleable assets, satisfying and providing for our liabilities and claims, and distributing net
proceeds to stockholders. The amount and timing of any distributions to stockholders would be determined by our board of
directors (or the trustee of a liquidating trust if our assets and liabilities are transferred to a liquidating trust pursuant to a plan of
liquidation and dissolution), in its sole discretion, and would depend, in part, on our ability to settle or otherwise resolve and
provide for all of our remaining liabilities and contingencies and convert any remaining assets into cash. In addition, after the
filing of a Certificate of Dissolution, the Company expects to follow a process which will involve appearances before the
Delaware courts to obtain the court’s confirmation that stockholder distributions are in compliance with Delaware law, including
whether the Company has set aside sufficient funds as a reserve for claims, and these proceedings may delay or limit such post-
dissolution distributions. If we pursue liquidation and dissolution, uncertainties as to the amount of our liabilities and the
disposition value, if any, of our remaining assets make it impractical to predict the net value which might ultimately be
distributable to our stockholders. No assurance can be given that available cash and any amounts received on any sale of assets
will be adequate to provide for our obligations, liabilities, expenses and claims and to make cash distributions to stockholders. We
also cannot assure you that the value of any distribution in liquidation would equal the price or prices at which our common stock
has recently traded or may trade in the future.
We cannot predict the timing, amount or mechanics of any potential distributions to our stockholders.
Many unknown variables will affect the amount, timing and mechanics of any potential distributions to stockholders. Factors that
could have a material effect on the amount of any potential future distributions include, but are not limited to, decreases in the
purchase price that third parties are willing to pay for our assets, a failure to sell our assets, the amount of assets and corporate
wind-down related operating and other expenses, the Company’s tax treatment, any required reserves to address potential
liabilities, including retained and contingent liabilities (including, but not limited to those arising from any sales of the Company’s
assets), and/or other unforeseen events. These and other factors, such as the procedures established under Delaware law for the
dissolution of a corporation, could also delay the timing of any potential distributions.
A delay in the sales of our assets is likely to decrease the funds available for distribution to stockholders.
Potential liabilities and expenses from operations (including, but not limited to operating costs such as salaries, directors’ fees,
directors’ and officers’ insurance, federal and state income taxes, payroll and local taxes, legal, investment banking, consulting
and accounting fees and miscellaneous office expenses) will continue to be incurred by us as we seek to sell our assets and wind-
down our operations. In the event that any sales of our assets are delayed, we may incur additional liabilities and expenses from
operations, that will reduce the net funds ultimately available for distribution to our stockholders.
27
Focus on our monetization strategy could materially and adversely affect our existing operating businesses.
Until such time, if any, as we are able to successfully implement our monetization strategy, we are subject to operational risks
related to our existing business. As a result of our monetization strategy, our management’s focus and attention on such efforts
may be diverted, which could cause disruption of our ongoing business or inconsistencies in standards and controls that could
negatively affect our ability to maintain third-party relationships. Moreover, we do not anticipate raising additional capital, which
could result in a shortfall in our cash resources that would limit our ability to operate our business profitably, and could otherwise
have a material adverse effect on our business, results of operations, financial condition and prospects. Management will be
required to devote sufficient attention to both the monetization strategy and continued development of our businesses until the
strategy is fully executed.
Our revenues from our Pharmaceutical segment consist entirely of sales of the Noden Products, and our revenues from our
Medical Devices segment consist entirely of sales and leasing of the LENSAR Laser System. The success of Noden is dependent
upon the success of the prescription pharmaceutical products sold under the brand names Tekturna, Tekturna HCT, Rasilez and
Rasilez HCT, and there can be no assurance that in the future we will be able to continue to successfully attain and maintain
significant market acceptance of our products among physicians, patients, third-party payors and others in the health care
community. Failure to do so could adversely affect the value we receive from any sale of such products or businesses as part of
our monetization strategy.
Also, we have experienced generic product competition for our products, which may increase in the future and reduce our market
share. In March 2019, under an agreement with Prasco Laboratories, and in anticipation of the launch of third party generic
aliskiren products by Par Pharmaceuticals, we launched in the United States an authorized generic form of Tekturna. There can be
no assurance that we will be able to maintain meaningful revenues from sales of this authorized generic product, and there can be
no assurance that we will be able to maintain market acceptance of this authorized generic product.
In addition, our acquisition of LENSAR resulted in establishing our Medical Devices segment. There can be no assurance that we
will be able to continue to successfully develop this segment on a commercial scale. Any failures or perceived difficulties in
developing these assets on a commercial sale in the future could have an adverse impact on our business, and could limit the value
we may realize with respect to LENSAR.
Our strategic investment in the common stock of Evofem is our sole asset in our Strategic Positions segment. The value of our
Evofem common stock is dependent upon the success of the product candidates under development by Evofem. Evofem is a pre-
commercial company and, as such, is not yet engaged in revenue-generating activities. As a minority stockholder of Evofem, we
have no control or oversight over the management of the Evofem business, and the value of our Evofem common stock will
depend on the Evofem management team’s ability to develop, raise capital and successfully market and sell Amphora, the failure
of which would have a material adverse effect on our investment and the value thereof. There can be no assurance as to the value
we are able to achieve regarding monetization of our investment in Evofem.
We are substantially dependent on our key employees to facilitate the consummation of our monetization strategy and to
continue to operate our business until the strategy is fully executed, and it may be difficult to retain such employees.
In December 2019, we implemented a strategic process to monetize our existing assets and return net proceeds to our
stockholders. In order to successfully operate our business prior to finalization of our monetization process, we must retain certain
of our key personnel. Certain of our employees have a significant amount of know-how and experience in our company, and the
loss of one or more of them could have a material and adverse effect on our operations or ability to implement our monetization
strategy. In an effort to retain key personnel for our monetization strategy, we implemented a wind-down retention plan that
provides certain benefits to employees in consideration for their continued employment with the company. Despite our efforts to
retain these employees, one or more may terminate their employment with us on short notice. The loss of the services of any of
these employees could potentially harm our ability to implement our monetization strategy and evaluate and pursue strategic
transactions, continue to operate our business during the execution of the strategy and fulfill our reporting obligations as a public
company. If we are unsuccessful in retaining qualified personnel, our ability to execute our monetization strategy may be
adversely affected.
Distributions to our stockholders may be treated as a dividend to the extent of our current and accumulated earnings and
profits, rather than a distribution in exchange for our stock.
28
Generally, a distribution by us to our stockholders would constitute dividends for U.S. federal income tax purposes to the extent
of our current and accumulated earnings and profits, as determined under U.S. federal income tax principles. However,
distributions by us to our stockholders in “complete liquidation” would be treated as payment in exchange for our stock. The term
“complete liquidation” is not defined in the Internal Revenue Code. While we expect our monetization strategy to be implemented
in a manner so as to cause distributions to our stockholders to qualify as one or more distributions in “complete liquidation” for
federal income tax purposes, there can be no assurance that efforts to do so will be successful or that the Internal Revenue Service
will not take a contrary position. To the extent that any distributions do not qualify as distributions in “complete liquidation”, they
will be treated for U.S. federal income tax purposes as dividends to our stockholders to the extent of our current and accumulated
earnings and profits.
Our results of operations and/or our monetization strategy could be materially negatively affected by market fluctuations,
business or economic disruptions or public health risks.
Our results of operations and/or our monetization strategy could be materially negatively affected by economic conditions
generally, both in the United States and elsewhere around the world. Concerns over inflation, energy costs, geopolitical issues,
public health emergencies, the availability and cost of credit, and the U.S. financial markets have in the past contributed to, and
may continue in the future to contribute to, increased volatility and diminished expectations for the economy and the markets. For
example, in December 2019, a novel strain of coronavirus surfaced in Wuhan, China. The coronavirus has impacted the global
economy, including limiting business activities in China and South Korea, and may impact our operations including, among other
things, sales to international customers (including those in China and South Korea) and the potential interruption of LENSAR’s
supply chain. Further, entities in which we have invested, including Evofem, may be negatively impacted by the coronavirus,
which could decrease the value of our investment and impact our ability to liquidate our investment on favorable terms, or at all.
The extent to which public health issues or pandemics, including the coronavirus, will impact our results of operations and the
results of operations of the entities in which we have invested will depend on future developments, which are highly uncertain and
cannot be predicted, including new information which may emerge concerning the severity of the coronavirus and the actions to
contain the coronavirus or treat its impact, among others. In addition, domestic and international equity and debt markets have
experienced and may continue to experience heightened volatility and turmoil based on domestic and international economic
conditions and concerns. In the event these economic conditions and concerns continue or worsen and the markets continue to
remain volatile, our results of operations could be adversely affected by those factors in many ways and our stock price or the
value of our assets may decline. In addition, we maintain significant amounts of cash and cash equivalents at one or more
financial institutions that are not federally insured. If economic instability continues, we cannot provide assurance that we will not
experience losses on these investments. The occurrence of any of the foregoing events could have a material adverse effect on our
business, results of operations and/or our ability to return value to our stockholders, including through our monetization strategy.
Our ability to successfully complete our monetization strategy could be materially negatively affected by public health
risks such as the recent outbreak of the coronavirus.
We are exploring and evaluating potential transactions in furtherance of our monetization strategy, the success of which may be
impacted by the growing spread of the coronavirus globally. In order to successfully monetize our assets, we must identify and
complete one or more transactions with third parties. The business and assets and the availability of potential buyers of our
company or certain of our assets may be significantly impacted by public health issues or pandemics, including the coronavirus.
The uncertain severity and impact of the coronavirus could result in reduced demand for our assets by third parties globally as
well as potentially affect our own ability to operate.
Even if we are able to identify potential transactions in furtherance of our monetization strategy, such buyers may be operationally
constrained or unable to locate financing on attractive terms or at all, which risk may be heightened due to the uncertainty of the
coronavirus and its impact. We are subject to increased risk that the growing spread of the coronavirus will affect the geographies,
both in the near term and in the future, of any third parties we identify as possible counterparties to any monetization transaction.
If financing is unavailable to potential buyers of our company or assets, or if potential buyers are unwilling to engage in various
transactions due to the uncertainty in the market, our ability to complete such acquisition would be significantly impaired.
Any negative impact on such third parties due to any of the foregoing events could cause costly delays and have a material
adverse effect on our ability to return value to our stockholders, including our ability to realize full value from a sale or other
disposition of our assets as part of our monetization strategy. In addition, if members of our management team were to be affected
by COVID-19, this could significantly delay or impair our ability to execute our monetization strategy.
Our ability to realize value from our investments in Evofem and LENSAR may depend on whether they can successfully
develop, gain approval for and commercialize products. Failure of Evofem to successfully develop, gain approval or
commercialize Amphora for prevention of pregnancy would likely cause its business to fail, which would diminish or
29
eliminate the value of our investment in Evofem. Failure of LENSAR to successfully continue its development and
commercialization of a next generation cataract laser surgery system could negatively affect our ability to realize full value
from a sale or other disposition of the business as part of our asset monetization strategy.
The value of our investment in Evofem and LENSAR may be dependent on their ability to successfully develop their respective
products.
Evofem resubmitted an NDA for Amphora for the prevention of pregnancy in 2019; however, there is no assurance that the FDA
will approve Amphora for this indication or for any other indication. Evofem has not received regulatory approval for any
product. Even though Evofem was able to successfully complete its clinical trial for Amphora for prevention of pregnancy, it may
be unable to obtain regulatory approval for Amphora for prevention of pregnancy. The state of development of Amphora,
including the FDA review and approval process, at the time we determine optimal to dispose of our investment position in
Evofem will have a significant impact in the potential value realized and is entirely out of our control. The commercial success of
Amphora will also depend in significant measure upon Evofem’s ability to obtain marketing approval from the FDA or other
regulatory authorities including an indication and labeling of sufficient scope to be commercially meaningful. Failure to achieve
marketing approval from the FDA or other regulatory authorities of a commercially meaningful indication and labeling may
substantially limit Evofem’s ability to market and promote Amphora and our ability to monetize or otherwise dispose of our
investment in Evofem. In addition, to obtain marketing approval of Amphora on schedule, manufacturing facilities operated by
third parties with which Evofem has contracted for the purpose of the supply of Amphora will need to pass a regulatory
inspection. Failure of the FDA to approve manufacture of Amphora at such third party facilities may delay approval, and
consequently affect the value of our investment in Evofem. Evofem will also likely incur significant costs associated with
launching and Amphora, including the development of a successful commercial team and strategy. The failure of Evofem to
successfully develop, gain marketing approval and commercialize Amphora would have a material adverse impact on our
investment in Evofem and could limit any upside, or result in a loss, on our investment, or limit our ability to generate significant
value for stockholders in connection with the potential disposition of our investment in furtherance of our monetization strategy.
LENSAR is developing and intends to commercialize a next generation cataract laser surgery system. The value we are able to
obtain from our investment in LENSAR may depend on the value investors and/or potential acquirors perceive in the next
generation system, which may not be in condition for approval or commercialization prior to our monetization of LENSAR. The
development process for new devices in the eye care industry and more general healthcare industry can sometimes be expensive,
prolonged and entail considerable uncertainty. Because of the complexities and uncertainties associated with ophthalmic research
and development in particular, and healthcare related research and development in general, products LENSAR is currently
developing, or that may be developed in the future, are subject to the risk that LENSAR may not complete the development
process or obtain the regulatory approvals required to market such products successfully. These complexities and risks could
significantly reduce the value we are able to achieve during the monetization process from our investment in LENSAR.
We may be unable to monetize our investment in Evofem due to the illiquidity of our shares, and our position in Evofem
may be subject to dilution and fluctuations in value, each of which could have a material and adverse impact on our
financial condition, results of operations and/or ability to monetize or otherwise dispose of our position.
As of December 31, 2019, we held approximately 28% of the shares of common stock of Evofem. Our shares of Evofem were
acquired in a private placement and, absent registration, are deemed to be restricted stock. A such, it may be difficult to sell our
Evofem shares in connection with our monetization strategy, and any such sale may be delayed due to the lead time required to
register such shares with the Securities and Exchange Commission.
Furthermore, it is expected that Evofem will seek to raise significant additional capital to finance its operations in the future.
Raising additional capital may cause substantial dilution in our investment and such financing activities could limit our ability to
generate a meaningful return or sell our investment as we attempt to monetize or otherwise dispose of our position.
We account for our investment in Evofem using the fair value method. Because a mark to market valuation will occur at the end
of each quarterly reporting period, changes in fair value will vary based upon the volatility of the stock price, and such changes in
fair value could have a material and adverse impact on our financial condition and results of operations.
If we do not meet the requirements for continued listing on The Nasdaq Stock Market, our common stock could be
delisted which would adversely affect the ability of our stockholders to sell shares of our common stock.
Our common stock is currently listed on The Nasdaq Stock Market. The Nasdaq Stock Market imposes continued listing
requirements that companies must meet to remain listed on that market. These requirements include, among other things,
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minimum levels of assets and revenues. The Nasdaq Stock Market also considers factors like the number of employees of a
company and a company’s ongoing revenue generating operations and plans. If we do not meet the requirements for continued
listing on The Nasdaq Stock Market, whether as a result of our monetization and distribution of net proceeds to stockholders or
otherwise, our common stock could be delisted. Further, upon dissolution, we anticipate that our stock would then be delisted
from Nasdaq and our stock transfer books closed, after which time it would not be possible for stockholders to publicly trade our
stock. At that point, the proportionate interests of all of our stockholders will be fixed on the basis of their respective stock
holdings at the close of business on the final record date, and, after the final record date, in general any distributions made by us
will be made solely to the stockholders of record at the close of business on the final record date. The delisting of our common
stock would have an adverse effect on the liquidity of our common stock, such as the ability of our stockholders to sell their
shares of our common stock, and its trading price. If our common stock ceases to be traded or quoted on any of the NYSE, the
NASDAQ Global Select Market or the NASDAQ Global Market, a “fundamental change” under each of our convertible notes
indentures would occur, which entitles the holders of the convertible notes issued under such indentures to require us to
repurchase the convertible notes of such holders. Delisting could also have other negative results, including, but not limited to, the
potential loss of confidence by employees, the loss of institutional investor interest and fewer opportunities with counterparties to
potential monetization transactions.
If we remain an independent company, we may need to obtain funds from additional financings or other sources for our
business activities. If we do not receive these funds, we may need to reduce, delay or eliminate some of our expenditures.
If we are not successful in implementing, or the board of directors decides to terminate, the monetization strategy, and we were to
therefore remain an independent company, we may need to raise additional capital to accomplish our business plan over the next
several years through debt or equity financing, joint ventures, license agreements, sale of assets, as well as various other financing
arrangements. If we obtain additional funds by issuing equity securities, dilution to stockholders may occur. There can be no
assurance as to the availability or terms upon which such financing and capital might be available.
Through our investments in Noden and Evofem, and our acquisition of LENSAR, we have a significant investment in the
commercialization of products worldwide, and our returns from these assets are subject to a number of risks associated
with international operations that could materially and adversely affect our business, results of operations and cash flows
and/or our ability to monetize or otherwise dispose of such assets.
As a result of our Noden and LENSAR operating businesses, and our strategic investment in Evofem, we are directly and
indirectly subject to a number of risks related to the sale of products worldwide, including:
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international regulatory requirements for drug and medical device marketing and pricing in foreign countries;
varied standards of care in various countries that could complicate the commercial success of products;
varied drug and medical device import and export rules;
varying standards for the protection of intellectual property rights which may result in reduced or compromised
exclusivity in certain countries;
unexpected changes in tariffs, trade barriers and regulatory requirements;
varied reimbursement systems and different competitive drugs indicated to treat the indications for which Noden
Products are being commercialized and medical devices indicated to treat the indications for which LENSAR
products are being commercialized;
economic weakness, including inflation, or political instability in particular foreign economies and markets;
widespread outbreak of health epidemics that could impact international sales and operations;
compliance with tax, employment, immigration and labor laws applicable to foreign operations;
compliance with the U.S. Foreign Corrupt Practices Act (“FCPA”), the UK Bribery Act, and other anti-corruption and
anti-bribery laws;
foreign taxes and duties;
foreign currency fluctuations and other obligations incident to doing business in another country;
workforce uncertainty in countries where labor unrest is more common than in the United States;
reliance on management, contract services organizations and other third parties that may be less experienced with
manufacturing and commercialization than the party from whom the Noden Products were acquired;
potential liability resulting from product liability laws or the activities of foreign distributors; and
business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters.
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In addition, our international operations could be affected by capital and exchange controls, expropriation and other restrictive
government actions as well as by political unrest, unstable governments and legal systems and inter-governmental disputes. Any
of these circumstances could materially and adversely affect our business, results of operations and cash flows, as well as
adversely affect our ability to monetize or dispose of such assets and/or reduce the proceeds we realize in such a monetization or
disposition.
The terms of our convertible notes indentures could negatively affect our ability to execute the monetization strategy.
In addition to the requirement under our convertible notes indentures for us to repurchase the convertible notes upon the election
of the holders of such convertible notes upon a “fundamental change,” each of the convertible notes indentures includes a merger
covenant that requires any successor company that purchases “substantially all” of our property and assets to assume the
obligations under such convertible notes indenture. There is no precise established definition of the phrase “substantially all”
under New York law, the law which governs each of our convertible notes indentures, and whether a transaction or series of
transactions constitutes “substantially all” of our property and assets depends on the consideration of both quantitative and
qualitative factors. Consequently, depending on the transactions pursued by us in connection with the monetization strategy and
the sequencing and timing of these transactions, our monetization strategy could result in a transfer of “substantially all” of our
properties and assets under each of our convertible notes indentures, which would require the transferee under such monetization
strategy to assume the obligations under such convertible notes indenture and could thus negatively affect our ability to execute
the monetization strategy. In order to minimize the impact of the merger covenants in our convertible notes indentures on our
ability to execute the monetization strategy, we could either conduct a tender offer for our outstanding convertible notes or could
solicit consents from the holders of our outstanding convertible notes to waive the requirements of such merger covenants, or
could pursue a combination of tender offers and consent solicitations, but we cannot assure you that any such tender offers or
consent solicitations would become effective or that they would be agreed upon on commercially acceptable terms.
We have in the past and are currently involved in, and expect that in the future we will from time to time be involved in,
litigation, either as a defendant or a plaintiff, which could have a negative impact on our business, results of operations
and cash flows and/or our monetization strategy.
Monitoring and defending against or prosecuting legal actions is time-consuming for our management, will require litigation
related expenses, and may detract from our ability to fully focus our internal resources on our operations and monetization
strategy. Moreover, we may be subject to additional litigation as we pursue potential transactions in furtherance of our
monetization strategy, and expect to be subject to increased risk of litigation following the completion of the divestiture of all or a
portion of our assets or businesses, a spin-off transaction, a merger, or any combination thereof. In addition, the stock markets
have experienced significant price and volume fluctuations that have affected the market prices for the common stock of
companies. These broad market fluctuations as well a broad range of other factors, including the realization of any of the risks
described in these “Risk Factors,” may cause the market price of our common stock to decline. In the past, securities class action
litigation has often been brought against a company involved in significant corporate transaction or following a decline in the
market price of its securities. Legal fees and costs incurred in connection with litigation may be significant. Depending on the
nature of the lawsuit, a decision adverse to our interests could result in the payment of substantial damages and could have a
material adverse effect on our cash flow, results of operations, financial position and ability to return value to stockholders, or
impact our rights in an adverse way. In addition, if we elect to file a certificate of dissolution, we may be subject to litigation with
potential or unknown claimants, which litigation will have an effect on the timing and ability of the Company to make
distributions to stockholders, and will be accompanied by litigation related costs and operations.
We rely on third-party manufacturers to manufacture our pharmaceutical products, and these third parties may not
perform adequately.
We do not have any operating manufacturing facilities for Noden Products, and do not expect to independently manufacture our
products under the Pharmaceutical segment. We currently rely on Novartis for a specified period of time to manufacture and
package the Noden Products.
Risks arising from reliance on third-party manufacturers include:
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reduced control and additional burdens of oversight as a result of using third-party manufacturers for all aspects of
manufacturing activities, including regulatory compliance and quality control and assurance;
termination or non-renewal of manufacturing and supply agreements with third parties in a manner or at a time that
may negatively impact commercialization activities; and
disruption in the operations of third-party manufacturers or suppliers unrelated to our products, including the
bankruptcy of the manufacturer or supplier or a catastrophic event affecting the third manufacturers or suppliers.
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In addition, difficulties or delays in product manufacturing and reliance on third-party manufacturing could adversely affect
performance of Noden and the Noden Products by virtue of regulatory actions, shut-downs, approval delays, withdrawals, recalls,
penalties, supply disruptions or shortages or force majeure events, reputational harm, product liability, unanticipated costs or
otherwise. Examples of such difficulties or delays include, but are not limited to, the possibility that the supply of incoming
materials may be delayed or become unavailable or be subject to increased costs and that the quality of incoming materials may
be substandard and not detected; the possibility that third-party manufacturers may fail to maintain appropriate quality standards
throughout the internal and external supply network and/or comply with cGMPs and other applicable regulations such as tracking
and tracing of products in the supply chain to enhance patient safety; risks to supply chain continuity as a result of natural or man-
made disasters at a supplier or vendor; or failure to maintain the integrity of the supply chains against intentional and criminal acts
such as economic adulteration, product diversion, product theft, and counterfeit goods. Any of these events could adversely affect
our ability to successfully commercialize our products and/or our ability to sell our products as part of our monetization strategy
or realize expected value in such a sale.
Our products are subject to the risks and uncertainties of branded pharmaceutical and medical device products.
If our products become subject to problems such as changes in prescription growth rates, product utilization, product liability
litigation, unexpected side effects, regulatory proceedings, manufacturing issues, publicity affecting doctor or patient confidence,
pressure from existing competitive products, changes in labeling, loss of patent protection (when applicable), or, if a new, more
effective treatment should be introduced, the adverse impact on our revenues could be significant. The occurrence of any of the
foregoing problems, or additional problems that may arise in the future, could materially and adversely affect our business, results
of operations and financial condition, and/or our ability to successfully monetize the underlying assets pursuant to our
monetization strategy.
For as long as we own our Noden business, we will continue to depend upon a limited number of wholesalers for a
significant portion of our revenues from the Noden Products, and the loss of, or significant reduction in sales to, any one of
these wholesalers could materially and adversely affect our business, results of operations and financial condition and/or
our ability to sell Noden or its assets, as well as materially reduce the amount of value we could realize in such a sale.
We sell the Noden Products primarily to wholesalers. Wholesalers sell the Noden Products to hospitals and pharmacies. We do not
promote the Noden Products to wholesalers, and they do not set or determine demand for Noden Products. Our ability to
successfully commercialize Noden Products will depend, in part, on the extent to which we are able to provide adequate
distribution of the Noden Products to patients. Although we have contracted with a number of wholesalers, they are expected
generally to carry a very limited inventory and may be reluctant to be part of our distribution network in the future if demand for
the product does not increase.
The use of pharmaceutical wholesalers involves certain risks, including, but not limited to, risks that these pharmaceutical
wholesalers will not provide us accurate or timely information regarding their inventories, demand from wholesaler customers
buying the Noden Products or complaints about the Noden Products, that these wholesalers will reduce their efforts or discontinue
to sell or support or otherwise not effectively sell or support the Noden Products, or not devote the resources necessary to sell the
Noden Products in the volumes and within the time frames that we expect.
Further, it is possible that these wholesalers could decide to change their policies or fees, or both, at some time in the future. This
could result in their refusal to carry smaller volume products such as Noden Products, or lower margins or the need to find
alternative methods of distributing the Noden Products. Although we believe we can find alternative channels to distribute the
Noden Products on relatively short notice, our revenue during that period of time may suffer and we may incur additional costs to
replace any such wholesaler. The loss of any large wholesaler as part of our distribution network, a significant reduction in sales
we make to wholesalers, or any failure to pay for the Noden Products we have shipped to them could materially and adversely
affect our business, results of operations and financial condition and/or our ability to sell Noden, as well as materially reduce the
amount of value we could realize in such a sale.
Certain of our income generating assets are secured by collateral, and we may be, or may become, under-secured by the
collateral, or such collateral may not have a value equal to our investment in the event of a default by our counterparties,
or may lose value, each of which could negatively affect our ability recuperate our capital expenditures in such income
generating assets.
Among our current income generating assets, the Wellstat Diagnostics loan and the CareView loan have exposed us to credit risk
due to default or potential default by the counterparty. To mitigate this risk at the initiation of the loans, we obtained security
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interests as collateral in the assets of such counterparty. Our credit risk in respect of such counterparty may be exacerbated when
the collateral held by us cannot be realized upon or is liquidated at prices not sufficient to recover the full amount we are due
pursuant to the terms of the particular credit agreement. This could occur in circumstances where the original collateral was not
sufficient to cover a complete loss (e.g., our interests were only partially secured) or may result from the deterioration in value of
the collateral, so that, in either such case, we are unable to recover our full capital outlay and any anticipated return. Obligations
under these credit agreements are secured by a pledge of substantially all the assets of the borrower and any of its subsidiaries
and, in the instance of Wellstat Diagnostics, by assets held by its affiliates. Although these loans are secured, we cannot guarantee
that we will be able to collect all or part of the amounts owed to us. If we are unable to collect any amount, or amounts collected
are not equal to our investment in the event of default by our counterparties, the value of our assets may decrease, which could
materially and adversely affect our business, results of operations and financial condition, and/or our ability to successfully
monetize the underlying assets pursuant to our monetization strategy. Additionally, we may face difficulty in collection efforts
with respect to the Wellstat Diagnostics and CareView loans. Such difficulties with the CareView loan could lead to litigation or
other legal procedures which may or may not be successful, and which will require significant financial and management
resources to address. We have been engaged in multiple legal proceedings with Wellstat Diagnostics and its affiliates related to
their credit agreement default, which is described in more detail in Note 25, Legal Proceedings, of this Annual Report. Any such
losses resulting therefrom could materially and adversely affect our business, results of operations and financial condition.
We are exposed to the credit risk of some of our customers, which could result in material losses.
In our Medical Devices segment, customers may finance through leasing the acquisition of certain devices, and we believe there
has been an increase in demand for customer financing through leasing in recent years. We may experience loss from a customer’s
failure to make payments according to the contractual lease terms. Our exposure to the credit risks relating to our lease financing
arrangements may increase if our customers are adversely affected by changes in healthcare laws, coverage and reimbursement,
economic pressures or uncertainty, or other customer-specific factors. The factors affecting our customers’ ability to make timely
payments according to the contractual lease terms are out of our control, and as a result, exposes us to additional risks that may
materially and adversely affect our business and results of operations. The occurrence of any such factors affecting our customers
may cause delays in payments or, in some cases, defaults on payment obligations, which could result in material losses.
Although we have programs in place that are designed to monitor and mitigate the associated risk, there can be no assurance that
such programs will be effective in reducing credit risks relating to these lease financing arrangements. If the level of credit losses
we experience in the future exceed our expectations, such losses could have a material adverse effect on our financial condition or
results of operations or adversely affect our ability to sell such assets as part of our monetization strategy.
We, our licensees, borrowers and royalty-agreement counterparties and the companies in which we invest may be unable
to maintain regulatory approvals for currently licensed products, or to obtain regulatory approvals or favorable pricing
for new products, and we or they may voluntarily remove currently licensed products from marketing and commercial
distribution. Any of such events, whether due to safety issues or other factors, could reduce our revenues or return on
investments, and could limit our ability to generate expected returns from the monetization of such assets.
We and our licensees, borrowers and royalty-agreement counterparties and companies in which we have invested, are subject to
stringent regulation with respect to product safety and efficacy by various international, federal, state and local authorities. Of
particular significance are the FDA requirements covering research and development, testing, manufacturing, quality control,
labeling and promotion of drugs and medical devices for human use in the United States. As a result of these requirements, the
length of time, the level of expenditures and the laboratory and clinical information required for approval of a biologic license
application or new drug application and approval or clearance of a medical device are substantial and can require a number of
years. In addition, even if our products, our licensees’, borrowers’ and royalty-agreement counterparties’ products or products of
companies in which we invest receive regulatory approval, we and they will remain subject to ongoing FDA and other
international regulations including, but not limited to, obligations to conduct additional clinical trials or other testing, changes to
the product label, new or revised regulatory requirements for manufacturing practices, written advisements to physicians and/or a
product recall or withdrawal. We, our licensees, borrowers and royalty-agreement counterparties and the companies in which we
invest may not maintain necessary regulatory approvals for our or their existing licensed products or we or our licensees may not
obtain necessary regulatory approvals on a timely basis, if at all, for any of our products, or the licensed products our licensees are
developing or manufacturing. Moreover, the current political environment in the United States is focused on potential reductions
in pricing for pharmaceutical and other healthcare products, which may negatively impact any existing or new products from
which our revenues would be derived. We are unable to control the pricing strategies used by our licensees, borrowers and
royalty-agreement counterparties and may have limited influence over the pricing strategies used by companies in which we
invest, and if they fail to use appropriate pricing strategies, or receive negative reactions to their pricing strategies, it could
negatively impact our revenues or return on investment. We may also select pricing strategies for our own products and medical
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devices that are less competitive than those of our competitors, or we may fail to obtain acceptable prices or an adequate level of
reimbursement for products or medical devices from third-party payors or governmental agencies, which could negatively impact
our revenues or return on investment and could limit our ability to generate expected returns from the monetization of such assets.
In addition, communications from government officials regarding pricing for pharmaceutical and other health care products could
have a negative impact on our stock price or the value of the assets we are seeking to monetize, even if such communications do
not ultimately impact our products, our licensees’, borrowers’ and royalty-agreement counterparties’ products or the products of
companies in which we invest. The occurrence of adverse events reported by any licensee, borrower or royalty-agreement
counterparty or company in which we invest may result in the revocation of regulatory approvals or decreased sales of the
applicable product due to a change in physicians’ willingness to prescribe, or patients’ willingness to use the applicable
product. We, our licensees, borrowers and royalty-agreement counterparties and the companies in which we invest could also
choose to voluntarily remove licensed products from marketing and commercial distribution. For example, in November 2011, the
FDA removed the indication for breast cancer from Avastin’s label. In 2005, Tysabri was temporarily suspended and then returned
to the market. In any of these cases, our revenues or return on investment could be materially and adversely affected. Moreover,
any value we may receive upon the potential sale of our company or other potential transaction in furtherance of our monetization
strategy could be materially and adversely affected.
In addition, the current regulatory framework could change, or additional regulations could arise at any stage during our licensees’
or invested company’s product development or marketing which may affect their ability to obtain or maintain approval of their
respective products. Delays in our licensees or the companies in which we have invested receiving regulatory approval for their
respective products or their failure to maintain existing regulatory approvals could have a material adverse effect on our business
or our ability to successfully implement our monetization strategy.
Many of our pharmaceutical products, investments, medical devices and income generating assets are in companies or
assets that have limited commercialized revenue-generating products or are dependent on the actions of unrelated third
parties, which may negatively impact the value we are able to realize as part of our monetization strategy.
Our ability to realize full value for certain of our assets (including in connection with executing a successful monetization
strategy) depends on the progress of such assets towards commercialization, and the ability to further the development in a
competitive and highly regulated market. Our or our counterparties or their licensees inability to do so would negatively affect our
investment returns and could limit our ability to generate expected returns from the monetization of such assets.
In addition, in connection with our income generating assets and our investments in our Strategic Positions segment, we are
dependent, to a large extent, on third parties to enforce certain rights for our benefit. For example, when we acquired certain
royalty rights from Assertio (formerly Depomed), which, as the licensor of certain patents, retains various rights, including the
contractual right to audit its licensees and to ensure those licensees are complying with the terms of the underlying license
agreements. Assertio also retained full responsibility to protect and maintain the intellectual property rights underlying the
licenses. While we have contractual rights to require Assertio to take action regarding many of these rights, because Assertio’s
economic interest in the license agreements is limited, it may not enforce or protect those rights as it otherwise would have had it
retained the full economic interest in the payments under the license agreements. Moreover, in respect of the royalty stream
relating to the Glumetza diabetes medication that we acquired from Assertio, which is the royalty right producing the highest
revenues from our Assertio acquired royalties, a single generic manufacturer was approved by the FDA in February 2013 and in
August 2016, two additional generic manufacturers were approved by the FDA to enter the US as provided for in settlement
agreements between Assertio and these generic manufacturers. In February 2016, Lupin Pharmaceuticals, Inc., and in August
2017, Teva Pharmaceutical Industries Ltd., and in July 2018, Sun Pharmaceutical, Inc., each launched a generic equivalent
approved product. We were aware of these settlement agreements, considered them in the cost of the acquiring this asset and
expected the entry of these generic products to reduce our Glumetza revenues. We are further aware of additional approved
generic extended release metformin products, which could negatively affect Glumetza revenues.
We and our companies’ licensees, borrowers and royalty-agreement counterparties face significant market pressures with
respect to our and their products, and the amount of revenues from our or their pharmaceutical products or medical
devices, or from our income generating assets that we receive are subject to various competitive and market factors that
may be outside of our control.
We and our companies, licensees, borrowers and royalty-agreement counterparties face competition from other pharmaceutical,
biotechnology, device and diagnostic companies. The introduction of new competitive products may result in lost market share for
us or our licensees, borrowers and royalty-agreement counterparties, reduced use of our or their products or devices, lower prices
and/or reduced sales, any of which could reduce our royalty revenues, or the revenues on which we rely to produce the returns on
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our acquisitions, and have a material adverse effect on our results of operations. Any such reduction to revenues could further
limit any realized value we may obtain in connection with the evaluation of potential transactions to monetize such assets.
The amount of any royalties or revenues, and the subsequent returns on our investments that we receive from our pharmaceutical
products, medical devices and/or income generating assets will depend on many factors, including the following:
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the timing and availability of generic product or devices competition for our products or devices, and our licensees’,
borrowers’ and royalty-agreement counterparties’ products or devices;
potential challenges or design-arounds to product, use or manufacturing related patents which provide exclusivity for
products and assets before their expiration by generic pharmaceutical manufacturers;
the size of the market for our products or devices, and our licensees’, borrowers’ and royalty-agreement counterparties’
products or devices;
the extent and effectiveness of the sales and marketing and distribution support for our licensees’, borrowers’ and
royalty-agreement counterparties’ products or devices and commercial infrastructure with respect to our products or
devices;
the existence of novel or superior products or devices to our products or devices, or our licensees’, borrowers’ and
royalty-agreement counterparties’ products or devices;
the availability of reduced pricing and discounts applicable to our licensees’, borrowers’ and royalty-agreement
counterparties’ products or devices;
stocking and inventory management practices related to our products or our licensees’, borrowers’ and royalty-agreement
counterparties’ products or devices;
limitations on indications for which our products or devices or our licensees’, borrowers’ and royalty-agreement
counterparties’ products or devices can be marketed; the competitive landscape for approved products or devices and
developing therapies that compete with our products or devices or our licensees’, borrowers’ and royalty-agreement
counterparties’ products or devices;
the ability of patients to be able to afford our products or devices, or our licensees’, borrowers’ and royalty-agreement
counterparties’ products or devices or obtain healthcare coverage that covers those products or devices;
acceptance of, and ongoing satisfaction with, our products or devices and our licensees’, borrowers’ and royalty-
agreement counterparties’ products or devices by the care providers, patients receiving therapy and third-party payors; or
the unfavorable outcome of any potential litigation relating to our products or devices and our licensees’, borrowers’ and
royalty-agreement counterparties’ products or devices.
For example, in mid-2019, Bausch Health announced potential price decreases on Glumetza, a royalty-bearing product under our
Assertio Royalty Agreement. These price decreases could negatively affect revenues and thus our royalties. Due to the
uncertainties caused by changes in pricing by third parties that are outside our control, including as a result of generic
competition, we may not be able to accurately estimate the impact on royalties on such sales paid to us for Glumetza or any other
product.
Additionally, Noden’s ’111 Patent, which was previously extended by virtue of pediatric testing requirements, expired in January
2019. While Noden has additional patent coverage related to drug formulation and manufacturing technology which relate to our
commercialization of Tekturna in the United States which has not yet expired, the expiration of the composition of matter patents
related to our Tekturna products will allow entry of competitors which have been able to design around the remaining formulation
patents. For example, in 2018, Noden settled a paragraph IV challenge with Anchen Pharmaceuticals, Inc. which allowed entry
into the market of a generic aliskiren product in March 2019, which generic product was subsequently made commercially
available through Par Pharmaceuticals, Inc. and competes with Tekturna and our authorized generic product. While we are
unaware of the entry of any additional third-party generic product at the present time, we cannot preclude the possibility that
another third-party generic version of aliskiren will be available at some time in the future. In March 2019, under an agreement
with Prasco Laboratories, we launched in the United States an authorized generic form of Tekturna which currently competes with
the Par Pharmaceuticals generic aliskiren product. The increase in competition and additional generic competition may have a
material and adverse effect on our ability to realize significant value for stockholders on the disposition or sale of the Noden
Products in furtherance of our monetization strategy.
We, our licensees and the companies in which we have invested must continue to protect our and their intellectual
property rights for us to protect the value of our assets and/or execute a successful monetization strategy.
Our success in protecting the value of our assets (including in connection with executing a successful monetization strategy) is
dependent in significant part on our ability and the ability of third parties in control of the assets in which we’ve invested to
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protect the scope, validity and enforceability of our and their intellectual property, including the patents, SPCs and license
agreements, all of which support our revenues. The scope, validity, enforceability and effective term of patents and SPCs can be
highly uncertain and often involve complex legal and factual questions and proceedings. In addition, the legal principles
applicable to patents in any given jurisdiction may be altered through changing court precedent and legislative action, and such
changes may affect the scope, strength and enforceability of our patent rights or the nature of proceedings which may be brought
related to the relevant patent rights. A finding in a proceeding related to patent rights which support our revenues which narrows
the scope or which affects the validity or enforceability of some or all of our patent rights could have a material impact on our
ability to continue to collect royalty payments from our investments or collect revenue from our sales of our pharmaceutical
products and medical devices. If the scope, validity and enforceability of our and their intellectual property were to be negatively
impacted prior to monetizing any such assets, our expected return on such assets could be materially and adversely affected.
Our reliance on sole and single source suppliers could harm our ability to meet demand for our products or devices in a
timely manner or within budget.
Some of the components necessary for the assembly of our Medical Devices segment are currently provided to us by sole-sourced
suppliers or single-sourced suppliers. We generally purchase components through purchase orders rather than long-term supply
agreements and generally do not maintain large volumes of inventory. While alternative suppliers exist and could be identified for
sole-sourced components, the disruption or termination of the supply of components could cause a significant increase in the costs
of these components, which could affect our operating results. A disruption or termination in the supply of components could also
result in our inability to meet demand for our products, which could harm our ability to generate revenues, lead to customer
dissatisfaction and damage our reputation. Furthermore, if we are required to change the manufacturer of a key component of our
products, we may be required to verify that the new manufacturer maintains facilities and procedures that comply with quality
standards and with all applicable regulations and guidelines. The delays associated with the verification of a new manufacturer
could delay our ability to manufacture our products in a timely manner or within budget, which may have a material adverse
impact on our business, financial condition, results of operations, or cash flows, as well as our ability to successfully monetize or
otherwise dispose of such products and/or related businesses.
Recently enacted and future legislation is expected to increase the difficulty and costs to maintain revenues from our
products, and in particular may negatively impact the pricing of our products and/or the ability to realize value as part of
our monetization strategy.
In the United States and some foreign jurisdictions, there have been, and we expect there will continue to be, a number of
legislative and regulatory changes and proposed changes regarding the healthcare system that could, among other things, affect
our ability to profitably sell our products.
For example, in the United States in March 2010, the Patient Protection and Affordable Care Act (“ACA”) was enacted to
increase access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and
abuse, add new transparency requirements for healthcare and the health insurance industries, impose new taxes and fees on the
health industry and impose additional health policy reforms. The law has continued the downward pressure on pharmaceutical
pricing, especially under the Medicare program, and increased the industry’s regulatory burdens and operating costs. Among the
provisions of the ACA of importance are the following:
• manufacturers and importers of certain branded prescription drugs with annual sales of more than $5 million made to
or covered by specified federal healthcare programs are required to pay an annual, non-tax deductible fee based on
each company’s market share of all such sales in the prior year;
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an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program for
brand and generic drugs;
a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated
for drugs that are inhaled, infused, instilled, implanted or injected;
extension of manufacturers’ Medicaid rebate liability to individuals enrolled in Medicaid managed care organizations;
expansion of eligibility criteria for Medicaid programs in certain states;
a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale
discounts off negotiated prices of applicable brand drugs to eligible beneficiaries under their coverage gap period, as a
condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D. Subsequent legislative
amendments have increased the point-of-sale discounted to 70%, effective 2019;
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program,
commonly referred to as the “340B Program”;
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a new requirement to annually report drug samples that manufacturers and distributors provide to physicians, also
known as the “Physicians Payment Sunshine Act”; and
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical
effectiveness research, along with funding for such research.
The potential financial impact of the ACA over the next few years will depend on a number of factors including policies reflected
in implementing regulations and guidance and changes in sales volumes for products affected by the new system of rebates,
discounts and fees. The taxes imposed by the ACA and the expansion in the government’s role in the U.S. healthcare industry may
result in decreased profits to us, lower reimbursement by payors for our products, and/or reduced medical procedure volumes, all
of which may have a material adverse effect on our business, financial condition and results of operations. The Trump
Administration and the U.S. Congress may take further action regarding the ACA, including, but not limited to, repeal or
replacement. For example, the Tax Cuts and Jobs Act of 2017 (the “2017 Tax Act”) was enacted, which, among other things,
removes penalties for not complying with the individual mandate to carry health insurance. On December 14, 2018, a U.S.
District Court Judge in the Northern District of Texas, ruled that the individual mandate is a critical and inseverable feature of the
ACA, and therefore, because it was repealed as part of the 2017 Tax Act, the remaining provisions of the ACA are invalid as well.
On December 18, 2019, the United States Court of Appeals for the Fifth Circuit affirmed the portion of the district court’s ruling
declaring the individual mandate unconstitutional and remanded for the district court to conduct analysis in the first instance on
which provisions of the statute are severable from it and thus remain intact. On March 2, 2020, the Supreme Court of the United
States granted certiorari to hear the case. While the Trump Administration and the Centers for Medicare & Medicaid Services
have both stated that the ruling will have no immediate effect, it is unclear how this decision, subsequent appeals, including the
aforementioned appeal, and other efforts to repeal and replace the ACA will impact the ACA. There may be additional challenges
and amendments to the ACA in the future, including continued litigation and legislation, and all or a portion of the ACA and
related subsequent legislation may be modified, repealed or otherwise invalidated through judicial challenge. We cannot predict
the ultimate content, timing or effect of any healthcare reform legislation or the impact of potential legislation on us and will
continue to evaluate the effect that the ACA and its possible repeal and replacement has on our business.
In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted. These
changes included automatic aggregate reductions to Medicare payments to providers of 2% per fiscal year as part of the federal
budget sequestration under the Budget Control Act of 2011, which went into effect in April 2013 and, due to subsequent
legislative amendments, will remain in effect through 2025 unless additional action is taken by Congress. In January 2013, the
American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to
several types of providers and increased the statute of limitations period in which the government may recover overpayments to
providers from three to five years. In addition, recently there has been heightened governmental scrutiny over the manner in
which drug manufacturers set prices for their commercial products and regulatory action aimed at reducing the cost of
prescription drugs. For example, in December 2019, the U.S. Department of Health and Human Services and the FDA issued a
proposed rule and draft guidance concerning two new pathways for importing lower-cost drugs into the United States. The
proposed rule, if finalized, would allow certain prescription drugs to be imported from Canada. The draft guidance describes
procedures for drug manufacturers to facilitate the importation of FDA-approved drugs and biologics manufactured abroad and
originally intended for sale in a foreign country into the United States. Additionally, President Trump’s administration has
proposed to establish an international pricing index that would tie domestic prices for certain drugs and biologics to the prices in
other countries with more aggressive drug price regulation. The implementation of cost containment measures or other healthcare
reforms may limit us from being able to generate revenue, attain profitability, or commercializing our products, which could have
a material adverse effect on business and results of operations.
In any event, we expect that additional state and federal healthcare reform measures will be adopted in the future, any of which
could limit the amounts that federal and state governments will pay for pharmaceutical products, which could result in reduced
demand for our products or our counterparties’ products or additional pricing pressures on our products or our counterparties’
products, as well as negatively affect our ability to successfully execute our monetization strategy.
Changes in third-party coverage and reimbursement may affect sales of our products, product sales from which we
receive royalty revenues and the products our borrowers sell to generate revenues and the growth of managed care
organizations (“MCOs”), is expected to increase pricing pressures on our products in the United States.
Sales of our products, product sales from which we receive royalties and the products our borrowers sell to generate revenues will
depend significantly on the extent to which reimbursement for the cost of such products and related treatments will be available to
physicians and patients from various levels of United States and international government health authorities, private health
insurers and other organizations. Third-party payers and government health administration authorities increasingly attempt to limit
and/or regulate the coverage and reimbursement of medical products and services, including branded prescription drugs. Changes
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in government legislation or regulation, such as the ACA, and changes in formulary or compendia listing or changes in private
third-party payers’ policies toward reimbursement for such products may reduce reimbursement of the cost of such products to
physicians, pharmacies and distributors. Decreases in third-party reimbursement could reduce usage of such products and sales to
collaborators, which may have a material adverse effect on our revenues derived from our products, those from which we receive
royalties from the business of our borrowers. In addition, macroeconomic factors may affect the ability of patients to pay or co-
pay for costs or otherwise pay for our products or the products from which we, our royalty counterparties and borrowers generate
revenues by, for example, decreasing the number of patients covered by insurance policies or increasing costs associated with
such policies. All of these factors could negatively impact our ability to sell or otherwise dispose of our assets or reduce the value
we realize as we seek to execute our monetization strategy.
In the United States in particular, the influence of MCOs has increased in recent years due to the growing number of patients
receiving coverage through MCOs. The growth of MCOs has increased pressure on drug prices as well as revenues for
pharmaceutical companies. One objective of MCOs is to contain and, where possible, reduce healthcare expenditures. MCOs
typically use formularies as a means to negotiate prices with pharmaceutical providers; physician protocols requiring prior
authorization for a branded product if a generic product is available or requiring the patient to first fail on one or more generic
products before permitting access to a branded medicine; volume purchasing; and long-term contracts. In addition, by placing
branded medicines on higher-tier status in their formularies or non-preferred tier status, MCOs transfer a portion of the cost of
those medicines to the patient (through and increase in co-payment requirements), resulting in significant out-of-pocket expenses
for the patient. This financial disincentive is a means by which MCOs manage drug costs and influence patients to use medicines
preferred by the MCOs.
Exclusion of a product from a formulary or other MCO-implemented restrictions can significantly impact drug usage in the MCO
patient population. Consequently, pharmaceutical companies compete to gain access to formularies for their products. Unique
product features, such as greater efficacy, better patient ease of use, or fewer side effects, are generally beneficial to achieving
access to formularies. Larger pharmaceutical companies have the ability to bundle available products and discounts in an effort to
place and maintain products on formulary. We will be responsible for meeting the requirements of MCO’s in the United States and
ensuring the competitive use of our products in a highly uncertain and changing environment. There can be no assurance that we
will be able to maintain the level of use of our products, and their inability to do so could have a material adverse impact on the
value we receive from any sale of our products or related businesses as part of our asset monetization strategy.
Generic products may increase pricing pressures on our products.
Although we believe that our products benefit from issued and/or pending patents as well as proprietary manufacturing
technology, one competitive challenge that our branded pharmaceuticals products face is or will be from generic pharmaceutical
manufacturers. Upon the expiration or loss of patent protection for a product, especially a small molecule product, the major
portion of revenues for that product may be dramatically reduced in a very short period of time. Several such competitors make a
regular practice of challenging product patents before their expiration. Also, manufacturers of generic pharmaceutical products
may file or have already filed an abbreviated NDA (“ANDA”) with the FDA seeking to market generic forms of our products
prior to the expiration of relevant patents owned by Noden. In June 2018, Noden Pharma DAC entered into a settlement
agreement with Anchen pursuant to which Anchen, the sole ANDA filer for Tekturna of which the Company is aware, was granted
a license from Noden to commercialize its generic form of aliskiren starting March 1, 2019. Under their license, Anchen may
commercialize their formulation of aliskiren, but is not permitted to commercialize a generic version of aliskiren which closely
relates to the formulation of Tekturna. As a result of a settlement with Anchen, Par Pharmaceuticals has commercialized a generic
form of aliskiren. Further patent litigation and other challenges to Noden’s patents would be costly and unpredictable, would
require extensive management time and resources, and may ultimately deprive us of market exclusivity for our products in a
given geographical territory. The FDA ANDA approval process exempts generics from costly and time-consuming clinical trials
to demonstrate their safety and efficacy, as long as they can scientifically demonstrate that their product performs in the same
manner as the innovator drug, thus allowing generic manufacturers to rely on the safety and efficacy data of the innovator’s
product. Generic competitors do not generally need to conduct clinical trials and can market a competing version of a product
after the expiration or loss of patent or regulatory exclusivity and often charge significantly lower prices. In addition, as noted
above, MCOs that focus primarily on the immediate cost of medicines often favor generics over branded drugs. Many
governments also encourage the use of generics as alternatives to brand-name drugs in their healthcare programs. Additionally,
certain foreign governments have indicated that compulsory licenses to patents may be granted in the case of national
emergencies or in other circumstances, which could diminish or eliminate sales and profits from those regions, negatively affect
our results of operations and cash flows, lead to an impairment charge of our long-lived assets or result in a material decline of
our revenue. In March 2019, under an agreement with Prasco Laboratories, we launched in the United States an authorized
generic form of Tekturna which competes with the Par Pharmaceuticals generic aliskiren product. Pricing pressure could reduce
the value of the product, and consequently of Noden, as we seek to sell it as part of our monetization strategy.
39
Our ability to generate revenue from an authorized generic may be limited in the future.
In March 2019, we launched in the United States aliskiren hemifumarate tablets, 150 mg and 300 mg, an authorized generic of
Tekturna, through Prasco Laboratories under an agreement with Noden Pharma DAC. Our ability to generate revenue related to
our authorized generic may be limited for a number of reasons, including, without limitation, the entry into the market of
additional generic products, the ratings for any existing or potential additional generic products, and the effect of increased
generic competition on pricing. All of these factors could materially and adversely affect Noden’s business and the value we are
able to realize as we seek to sell Noden as part of our asset monetization strategy.
Our products may develop undesirable side effects or have other properties impacting safety or efficacy.
Undesirable side effects caused by our products or similar products sold or developed by other companies, could reveal a high and
unacceptable severity and prevalence of side effects or adverse events resulting in a number of potentially significant negative
consequences, including:
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regulatory authorities may withdraw approvals of such product;
regulatory authorities may require additional warnings on the label;
• we may be required to create a medication guide outlining the risks of such side effects for distribution to patients;
• we could be sued and held liable for harm caused to patients; and
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our reputation may suffer.
Any of these events could result in a material decline of our revenue negatively affecting the value of our assets and the proceeds
we realize from a sale of such assets as part of our monetization strategy.
We may have significant product liability exposure and our insurance may not cover all potential claims.
We are exposed to product liability and other claims in the event that our technologies or products are alleged to have caused
harm. Any potential product liability claims could exceed the amount of our insurance coverage or may be excluded from
coverage under the terms of our policies. Our insurance may not be renewed at a cost and level of coverage comparable to that
then in effect. Any of these events could materially and adversely affect our business, results of operations and financial
condition, as well as the ability to successfully execute our monetization strategy.
Our third-party contractors as well as our own employees may engage in misconduct or other improper activities,
including noncompliance with regulatory standards and requirements, which could result in significant liability for us and
harm our reputation.
We are exposed to the risk of fraud or other misconduct in connection with international business operations and our reliance on
third-party contractors to manage and conduct those activities with respect to our products. These risks include potential failures
to:
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comply with FDA regulations or similar regulations of comparable foreign regulatory authorities;
provide accurate information to the FDA or comparable foreign regulatory authorities;
comply with manufacturing standards applicable to our products;
comply with federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations
established and enforced by comparable foreign regulatory authorities;
comply with the FCPA, the UK Bribery Act, and other anti-bribery laws;
report financial information or data and our business affairs accurately; or
disclose unauthorized activities to us.
Our investment in Noden, an Irish entity, subjects us to both United States and international tax laws with respect to the
structure and operations of our business and the business conducted by Noden, which are subject to continued scrutiny
and change by governments and may result in additional liabilities that may affect our results of operations or reduce the
proceeds we are able to realize as we seek to sell Noden or its assets as part of our monetization strategy.
Noden is incorporated in Ireland and maintains the performance of certain functions and ownership of certain assets in a more
tax-efficient jurisdiction than the United States. Taxing authorities, such as the United States Internal Revenue Service (“IRS”),
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actively audit and otherwise challenge these types of arrangements, and have regularly done so in the pharmaceutical industry. We
remain subject to reviews and audits by the IRS and other taxing authorities from time to time, and the IRS or other taxing
authority may challenge our structure and intra-company arrangements through an audit or lawsuit. Responding to or defending
against those and other challenges from taxing authorities could be expensive and, in any event, would consume time and other
resources, and divert management’s time and focus, as well as restrict or delay our ability to sell Noden. We generally cannot
predict whether taxing authorities will conduct an audit or file a lawsuit challenging our current structure, the cost involved in
responding to any inquiry or audit or lawsuit, or the outcome. If we are unsuccessful, we may be required to consolidate income
and pay greater taxes as well as interest, fines or penalties, and may be obligated to pay increased taxes in the future, any of which
could have a material adverse effect on our results of operations or the proceeds we are able to realize from a sale of Noden.
The regulatory clearance and approval processes of the FDA are lengthy, time-consuming and inherently unpredictable,
and if we are ultimately unable to obtain regulatory clearance or approval for any new product candidates or
modifications to existing products, our business or monetization strategy could be harmed.
The time required to obtain approval or clearance of a drug or device, respectively, by the FDA is unpredictable but typically
takes many years following the commencement of clinical trials, if required, and depends upon numerous factors, including the
substantial discretion of the regulatory authorities. In addition, approval or clearance policies, regulations, or the type and amount
of clinical data necessary to gain marketing authorization may change during the course of a product candidate’s development and
may vary among jurisdictions. We are not permitted to market any new product candidates in the United States until we receive
regulatory approval of an NDA for any new drug product candidate or clearance of a 510(k) premarket notification (or approval
of a PMA application) for any new medical device from the FDA, unless the device is exempt from such requirements.
Prior to obtaining approval to commercialize a drug product candidate in the United States or abroad, we or our collaborators
must demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction of the FDA, that such
product candidates are safe and effective for their intended uses. Results from preclinical studies and clinical trials can be
interpreted in different ways. Even if we believe the preclinical or clinical data for our product candidates are promising, such
data may not be sufficient to support approval by the FDA and other regulatory authorities. The FDA may also require us to
conduct additional preclinical studies or clinical trials for our product candidates either prior to or post-approval, or it may object
to elements of our clinical development program.
In the United States, before we can market a new medical device, or a new use of, new claim for or significant modification to an
existing product, we must first receive either clearance under Section 510(k) of the FFDCA or approval of a PMA application
from the FDA, unless an exemption applies. In the 510(k) clearance process, before a device may be marketed, the FDA must
determine that a proposed device is “substantially equivalent” to a legally-marketed “predicate” device, which includes a device
that has been previously cleared through the 510(k) process, a device that was legally marketed prior to May 28, 1976 (pre-
amendments device), a device that was originally on the U.S. market pursuant to an approved PMA and later down-classified, or a
510(k)-exempt device. To be “substantially equivalent,” the proposed device must have the same intended use as the predicate
device, and either have the same technological characteristics as the predicate device or have different technological
characteristics and not raise different questions of safety or effectiveness than the predicate device. Clinical data are sometimes
required to support substantial equivalence. In the PMA process, the FDA must determine that a proposed device is safe and
effective for its intended use based, in part, on extensive data, including, but not limited to, technical, pre-clinical, clinical trial,
manufacturing and labeling data. The PMA process is typically required for devices that are deemed to pose the greatest risk, such
as life-sustaining, life-supporting or implantable devices.
Modifications to products that are approved through a PMA application generally require FDA approval. Similarly, certain
modifications made to products cleared through a 510(k) may require a new 510(k) clearance. Both the PMA approval and the
510(k) clearance process can be expensive, lengthy and uncertain. The FDA’s 510(k) clearance process usually takes from three to
12 months, but can last longer. The process of obtaining a PMA is much costlier and more uncertain than the 510(k) clearance
process and generally takes from one to three years, or even longer, from the time the application is filed with the FDA. In
addition, a PMA generally requires the performance of one or more clinical trials. Despite the time, effort and cost, we cannot
assure you that any particular device will be approved or cleared by the FDA. Any delay or failure to obtain necessary regulatory
approvals could harm our business or monetization strategy.
In the United States, we have obtained 510(k) premarket clearance from the FDA to market the LENSAR device. An element of
our strategy is to continue to add new features and seek new indications. We expect that any such modifications may require new
510(k) clearance; however, future modifications may be subject to the substantially more costly, time-consuming and uncertain
PMA process. If the FDA requires us to go through a lengthier, more rigorous examination for future products or modifications to
41
existing products than we had expected, product introductions or modifications could be delayed or canceled, which could cause
our sales to decline.
The FDA can delay, limit or deny clearance or approval of our product candidates or require us to conduct additional preclinical
or clinical testing or abandon a program for many reasons, including:
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the FDA’s disagreement with the design or implementation of our clinical trials;
negative or ambiguous results from our clinical trials;
results that may not meet the level of statistical significance required by the FDA for approval or clearance;
serious and unexpected drug-related adverse events experienced by participants in our clinical trials or by individuals
using drugs similar to our product candidates;
our inability to demonstrate to the satisfaction of the FDA that our product candidates are safe and effective for the
proposed indication or, in the case of our medical devices, are substantially equivalent to our proposed predicate
device;
the FDA’s disagreement with the interpretation of data from preclinical studies or clinical trials;
our inability to demonstrate that the clinical and other benefits of our product candidates outweigh any safety or other
perceived risks;
the FDA’s requirement for additional preclinical studies or clinical trials;
the FDA’s disagreement regarding the formulation, labeling or the specifications of our product candidates;
the FDA’s agency’s failure to approve the manufacturing processes or facilities of third-party manufacturers with which
we contract; or
the potential for approval policies or regulations of the FDA to significantly change in a manner rendering our clinical
data insufficient for approval.
Of the large number of products in development, only a small percentage successfully complete the FDA marketing authorization
process and become commercialized. The lengthy process as well as the unpredictability of outcomes from future clinical trials
may result in our failing to obtain regulatory authorization to market our product candidates.
Even if we eventually complete clinical testing and receive approval of an NDA, 510(k), or similar foreign marketing application
for our product candidates, the FDA may grant approval contingent on the performance of costly additional clinical trials,
including Phase 4 clinical trials, or in the case of our drugs, the implementation of a Risk Evaluation and Mitigation Strategy
(“REMS”), which may be required to ensure safe use of the drug after approval. The FDA also may authorize a product candidate
for a more limited indication or patient population than we originally requested, and the FDA may not authorize us to market the
product with the labeling that we believe is necessary or desirable for the successful commercialization of a product candidate.
Any delay in obtaining, or inability to obtain, applicable regulatory authorization would delay or prevent commercialization of
that product candidate. In addition, our drugs may become subject to class-wide REMS that implicate all manufactures of a
particular class of drugs, which could significantly impact our ability to commercialize our drugs and could reduce their market
potential.
The safety and efficacy of our medical device products is not yet supported by long-term clinical data, which could limit
sales, and our products might therefore prove to be less safe or effective than initially thought.
Our medical device products have received premarket clearance under Section 510(k) of the FFDCA. In the 510(k) clearance
process, before a device may be marketed the FDA must determine that a proposed device is “substantially equivalent” to a
legally-marketed “predicate” device, which includes a device that has been previously cleared through the 510(k) process, a
device that was legally marketed prior to May 28, 1976 (pre-amendments device), a device that was originally on the U.S. market
pursuant to an approved PMA application and later down-classified, or a 510(k)-exempt device. This process is typically shorter
and generally requires the submission of less supporting documentation than the FDA’s PMA application process and does not
always require long-term clinical studies.
In the European Economic Area (“EEA”) manufacturers of medical devices are required by the Medical Devices Directive to
collect post-marketing clinical data in relation to their CE marked medical devices. Post-market surveillance includes the conduct
of post-market clinical follow-up studies permitting manufacturers to gather information concerning quality, safety or
performance of medical devices after they have been placed on the market in the EEA. All information collected as part of the
post-market surveillance process must be reviewed, investigated and analyzed on a regular basis in order to determine whether
trending conclusions can be made concerning the safety or performance of the medical device and decisions must be taken in
relation to the continued marketing of medical devices currently on the market. If development of these products is continued by
42
us, we would expect to incur ongoing costs to comply with these post-market clinical obligations in EEA markets for so long as
we continue to market and sell products in those markets.
Given the foregoing regulatory environment in which we operate, we lack the breadth of published long-term clinical data
supporting the safety and efficacy of our medical devices and the benefits they offer that might have been generated in connection
with other approval processes. For these reasons, the market may be slow to adopt our products, we may not have comparative
data that our competitors have or are generating, and we may be subject to greater regulatory and product liability risks.
In addition, while our LENSAR® Laser Systems were first cleared in 2010 in the United States and in 2013 in EEA, we have
limited complication or patient success rate data with respect to uses of our products. In addition, if future studies and experience
indicate that our products cause unexpected or serious complications or other unforeseen negative effects, we could be subject to
mandatory product recalls or suspension or withdrawal of clearance in the United States or the EEA, and our reputation with
physicians, patients and healthcare providers may suffer.
The misuse or off-label use of our products may harm our reputation in the marketplace, result in injuries that lead to
product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have
engaged in the promotion of these uses, any of which could be costly to our business.
Our products have been approved or cleared by the FDA for specific indications. Our marketing does not promote our products
for uses outside of these cleared or approved indications for use, known as “off-label uses.” We cannot, however, prevent a
physician from using or prescribing our products off-label, when in the physician’s independent professional medical judgment he
or she deems it appropriate. There may be increased risk of injury to patients if physicians prescribe or use our products off-label.
Furthermore, the use of our products for indications other than those cleared or approved by the FDA or any foreign regulatory
body may not effectively treat such conditions, which could harm our reputation in the marketplace among physicians and
patients.
If the FDA or any foreign regulatory body determines that our promotional materials or training constitute promotion of an off-
label use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions,
including the issuance or imposition of a warning letter or an untitled letter, which is used for violators that do not necessitate a
warning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign
enforcement authorities might take action under other regulatory authority, such as false claims laws, if they consider our business
activities to constitute promotion of an off-label use, which could result in significant penalties, including, but not limited to,
criminal, civil and administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare
programs and the curtailment of our operations.
Moreover, if our products do not comply with regulatory requirements, including with respect to labeling and promotion, or are
misused or used with improper technique, we may become subject to costly litigation. Product liability claims could divert
management’s attention from our core business, be expensive to defend and result in sizeable damage awards against us that may
not be covered by insurance. In addition, any of the events described above could harm our business and/or negatively affect our
ability to monetize such assets or the value we may receive from such a monetization.
Even though we have received regulatory approval for our drug product candidates and clearance of a premarket
notification for our devices, we are subject to ongoing regulatory obligations and continued regulatory review, which
results in significant additional expense, and we may be subject to penalties, if we fail to comply with regulatory
requirements or experience unanticipated problems with our product candidates.
Any regulatory approvals or clearances that we receive may be subject to limitations on the indicated uses for which the product
may be marketed or the conditions of approval, or contain requirements for potentially costly post-market testing and surveillance
to monitor the safety and efficacy of the product candidate. The FDA may also require a REMS as a condition of approval of our
product candidates, which could include requirements for a medication guide, physician communication plans or additional
elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.
In addition, once the FDA or a comparable foreign regulatory authority authorizes a product for marketing, the manufacturing
processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and
recordkeeping are subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety
and other post-marketing information and reports, registration, as well as continued compliance with cGMPs and GCP
requirements for any clinical trials that we conduct post-approval. For example, we are subject to the medical device reporting
requirements for our medical device products, which require us to report to the FDA when we receive or become aware of
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information that reasonably suggests that one or more of our medical devices may have caused or contributed to a death or serious
injury or malfunctioned in a way that, if the malfunction were to recur, it could cause or contribute to a death or serious injury.
The timing of our obligation to report is triggered by the date we become aware of the adverse event as well as the nature of the
event. We may fail to report adverse events of which we become aware within the prescribed timeframe. We may also fail to
recognize that we have become aware of a reportable adverse event, especially if it is not reported to us as an adverse event or if it
is an adverse event that is unexpected or removed in time from the use of the product. If we fail to comply with our reporting
obligations, the FDA could take enforcement action against us. We are subject to similar post-market reporting requirements with
respect to our drug products.
Later discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity
or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory
requirements, may result in, among other things:
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restrictions on the marketing or manufacturing of our product candidates, withdrawal of the product from the market, or
voluntary or mandatory product recalls;
fines, warning letters or holds on clinical trials;
refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension
or revocation of approvals;
product seizure or detention, or refusal to permit the import or export of our product candidates; and
injunctions or the imposition of civil or criminal penalties.
The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that
could impact our business. If we are slow or unable to adapt to changes in existing requirements or the adoption of new
requirements or policies, or if we are not able to maintain regulatory compliance, we may fail to obtain any marketing approvals,
lose any marketing approval that we have obtained and we may not achieve or sustain profitability.
We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or
administrative action, either in the United States or abroad. For example, certain policies of the Trump administration may impact
our business and industry. Namely, the Trump administration has taken several executive actions, including the issuance of a
number of Executive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage
in routine regulatory and oversight activities such as implementing statutes through rulemaking, issuance of guidance, and review
and approval of marketing applications. If these executive actions impose constraints on FDA’s ability to engage in oversight and
implementation activities in the normal course, our business may be negatively impacted.
We are subject to extensive healthcare laws, regulation and enforcement, and our failure to comply with those laws could
have a material adverse effect on our results of operations and financial condition.
We are subject to potential risk of civil and criminal enforcement by the federal government and the states and foreign
governments due to the acquisitions of Noden and LENSAR. Our business practices and relationships with providers are subject
to scrutiny under these laws. We are also be subject to privacy and security regulation related to patient, customer, employee and
other third-party information by both the federal government and the states and foreign jurisdictions in which we conduct our
business. The laws, regulations and codes that may affect us in the United States include:
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the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully
soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or
recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and
Medicaid programs. A person or entity does not need to have actual knowledge of the statute or specific intent to
violate it to have committed a violation. The U.S. government has interpreted this law broadly to apply to the
marketing and sales activities of manufacturers. Moreover, the government may assert that a claim including items or
services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for
purposes of the federal civil False Claims Act. Violations of the federal Anti-Kickback Statute may result in civil
monetary penalties plus up to three times the remuneration involved. Civil penalties for such conduct can further be
assessed under the federal False Claims Act. Violations can also result in criminal penalties and imprisonment of up
to 10 years. Similarly, violations can result in exclusion from participation in government healthcare programs,
including Medicare and Medicaid;
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federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things,
individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare,
Medicaid, or other third-party payors that are false or fraudulent. Private individuals can bring False Claims Act ‘‘qui
tam’’ actions, on behalf of the government and such individuals, commonly known as ‘‘whistleblowers,’’ may share in
amounts paid by the entity to the government in fines or settlement. When an entity is determined to have violated the
federal civil False Claims Act, the government may impose civil fines and penalties for each false claim, plus treble
damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;
the federal Civil Monetary Penalties Law, which prohibits, among other things, offering or transferring remuneration
to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision
to order or receive items or services reimbursable by the government from a particular provider or supplier;
The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created new federal criminal
statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements
relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have
actual knowledge of the statute or specific intent to violate it to have committed a violation;
HIPAA, as amended by the Health Information for Economic and Clinical Health Act of 2009 (“HITECH”), and its
implementing regulations, which imposes certain requirements on certain covered healthcare providers, health plans
and healthcare clearinghouses as well as their business associates that perform services for them that involve
individually identifiable health information, relating to the privacy, security and transmission of individually
identifiable health information, without appropriate authorization, including mandatory contractual terms as well as
directly applicable privacy and security standards and requirements. Failure to comply with the HIPAA privacy and
security standards can result in civil monetary penalties for each violation and, in certain circumstances, criminal
penalties with fines for each violation and/or imprisonment. State attorneys general can also bring a civil action to
enjoin a HIPAA violation or to obtain statutory damages on behalf of residents of his or her state;
the federal physician sunshine requirements under the ACA, which require manufacturers of drugs, devices,
biologics, and medical supplies to report annually to the Centers for Medicare and Medicaid Services (“CMS”),
information related to payments and other transfers of value to physicians, other healthcare providers, and teaching
hospitals, and ownership and investment interests held by physicians and other healthcare providers and their
immediate family members. Applicable manufacturers are required to submit annual reports to CMS. Failure to
submit required information may result in civil monetary penalties for all payments, transfers of value or ownership
or investment interests that are not timely, accurately, and completely reported in an annual submission, and may
result in liability under other federal laws or regulations;
guidelines promulgated by the Office of Inspector General of the U.S. Department of Health and Human Services
related to pharmaceutical and medical device company regulatory compliance programs and the PhRMA Code on
Interactions with Healthcare Professionals and the AdvaMed Code of Ethics, as amended;
foreign and state law equivalents of each of the above federal laws, such as the FCPA, anti-kickback and false claims
laws that may apply to items or services reimbursed by any third-party payor, including commercial insurers;
state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance
guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict
payments that may be made to healthcare providers and other potential referral sources;
state laws that require drug manufacturers to report information related to payments and other transfers of value to
physicians and other healthcare providers or marketing expenditures; and
state laws governing the privacy and security of health information in certain circumstances, many of which differ
from each other in significant ways, thus complicating compliance efforts.
These laws and regulations, among other things, constrain our business, marketing and other promotional activities by limiting the
kinds of financial arrangements, including sales programs, we may have with hospitals, physicians or other potential purchasers
of our products. Due to the breadth of these laws, the narrowness of statutory exceptions and regulatory safe harbors available,
and the range of interpretations to which they are subject, it is possible that some of our current or future practices might be
challenged under one or more of these laws.
To enforce compliance with the healthcare regulatory laws, certain enforcement bodies have recently increased their scrutiny of
interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions,
convictions and settlements in the healthcare industry. Responding to investigations can be time-and resource-consuming and can
divert management’s attention from the business. Additionally, as a result of these investigations, healthcare providers and entities
may have to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity
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agreement. Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business.
Even an unsuccessful challenge or investigation into our practices could cause adverse publicity and be costly to respond to.
We do not have experience in establishing the compliance programs necessary to comply with this complex and evolving
regulatory environment and our reliance on Noden and LENSAR to operate and address these requirements appropriately
increases the risks that we may be found to violate the applicable laws and regulations. If we are found to be in violation of any of
such laws or any other governmental regulations, we may be subject to penalties, including administrative, civil and criminal
penalties, damages, fines, the exclusion from participation in federal and state healthcare programs, imprisonment, contractual
damages, reputational harm, disgorgement and the curtailment or restructuring of our operations, any of which could materially
and adversely affect interests in our products, including having a material adverse effect on our financial results or our ability to
monetize such products or related businesses as part of our monetization strategy.
An impairment charge with respect to intangible assets could have a material impact on our results of operations and/or
negatively affect our monetization strategy.
We periodically evaluate our intangible assets to determine whether all or a portion of their carrying values may be impaired, in
which case a charge to earnings may be necessary. The occurrence of certain events, changes in business strategy, government
regulations or economic or market conditions may cause us to remeasure the fair value of certain assets and liabilities. Our
judgments regarding the existence of impairment indicators are based on, among other things, legal factors, market conditions,
and operational performance. If an event or events occur that would cause us to revise our estimates and assumptions used in
analyzing the value of our intangible assets, such revision could result in an impairment charge that could have a material impact
on our results of operations in the period in which the impairment occurs. For example, at December 31, 2019, we recorded an
impairment charge of $22.5 million for the Noden intangible assets related to our monetization strategy and updated forecasts for
Noden. As a result of this impairment charge, which was based on the estimated fair value of the assets, the remaining carrying
value of these intangible assets were determined to be $10.1 million. For additional information on the impairment charge, see
Note 10, Intangible Assets.
We may use a certain amount of cash from time to time in order to repurchase or satisfy obligations relating to our
convertible notes. The maturity or conversion of any of our convertible notes could materially and adversely affect our
business, results of operations and financial condition.
We are required to repay the full principal amount of approximately $19.2 million in principal amount outstanding under the
2.75% Convertible Senior Notes due December 1, 2021 (the “December 2021 Notes”) and approximately $11.5 million in
principal amount outstanding plus an additional accreted amount of $1.5 million under the 2.75% Convertible Senior Notes due
December 1, 2024 (the “December 2024 Notes”) if not previously converted or repurchased.
Our ability to make scheduled payments of the principal of, to pay interest on, to pay any cash due upon conversion of, or to
refinance, our indebtedness, depends on our future performance, which is subject to economic, financial, competitive and other
factors beyond our control. Our business may not generate cash flow from operations in the future sufficient to service our debt
and make necessary capital expenditures. If we are unable to generate such cash flow, we may be required to adopt one or more
alternatives, such as selling assets, restructuring debt or obtaining additional equity capital on terms that may be onerous or highly
dilutive. Our ability to refinance our indebtedness will depend on the capital markets and our financial condition at such time. We
may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default
on our debt obligations.
Holders of the December 2021 Notes may convert their notes at their option under the following conditions at any time prior to
the close of business on the business day immediately preceding June 1, 2021: (i) during any fiscal quarter (and only during such
fiscal quarter) commencing after the fiscal quarter ending June 30, 2017, if the last reported sale price of our common stock for at
least 20 trading days (whether or not consecutive), in the period of 30 consecutive trading days, ending on, and including, the last
trading day of the immediately preceding fiscal quarter, exceeds 130% of the conversion price for the notes on each applicable
trading day; (ii) during the five business day period immediately after any five consecutive trading-day period (the measurement
period), in which the trading price per $1,000 principal amount of the December 2021 Notes for each trading day of that
measurement period was less than 98% of the product of the last reported sale price of our common stock and the conversion rate
for the notes for each such trading day; or (iii) upon the occurrence of specified corporate events. Holders of the December 2024
Notes may convert their notes at their option under the following conditions at any time prior to the close of business on the
business day immediately preceding June 1, 2024: (i) during any fiscal quarter (and only during such fiscal quarter) if the last
reported sale price of our common stock for at least 20 trading days (whether or not consecutive), in the period of 30 consecutive
trading days, ending on, and including, the last trading day of the immediately preceding fiscal quarter, exceeds 130% of the
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conversion price for the notes on each applicable trading day; (ii) during the five business day period immediately after any five
consecutive trading-day period (the measurement period), in which the trading price per $1,000 principal amount of the December
2024 Notes for each trading day of that measurement period was less than 98% of the product of the last reported sale price of our
common stock and the conversion rate for the notes for each such trading day; or (iii) upon the occurrence of specified corporate
events.
The December 2021 Notes and the December 2024 Notes may be settled by paying or delivering, as applicable, cash, shares of
our common stock or a combination of cash and shares of our common stock, at our election. During the year ended December
31, 2019 we repurchased approximately $44.8 million in principal amount of our December 2021 Notes and approximately $74.6
million in principal amount of our December 2024 Notes. In furtherance of our monetization strategy, we expect to use a certain
amount of cash from time to time in order to repurchase or satisfy obligations relating to our convertible notes which could
adversely affect the amount or timing of any distribution to our stockholders.
The conversion or any future exchanges of any of the December 2021 Notes or the December 2024 Notes into shares of our
common stock would have a dilutive effect that could cause our stock price to go down.
Until June 1, 2021, the December 2021 Notes are convertible into shares of our common stock only if specified conditions are
met and thereafter convertible at any time, at the option of the holder. Until June 1, 2024, the December 2024 Notes are
convertible into shares of our common stock only if specified conditions are met and thereafter convertible at any time, at the
option of the holder. We have reserved shares of our authorized common stock for issuance upon conversion of the December
2021 Notes and the December 2024 Notes. Upon conversion, the principal amount of our convertible notes may be settled in, at
our option, cash, common stock or a combination of cash and common stock. If any or all of these convertible notes are converted
into shares of our common stock, our existing stockholders will experience immediate dilution of voting rights and our common
stock price may decline. Furthermore, the perception that such dilution could occur may cause the market price of our common
stock to decline. If our stock price is negatively impacted, any value we may receive upon the potential sale of our company or
other potential transaction in furtherance of our monetization strategy could be materially and adversely affected.
We entered into capped call transactions in connection with the issuance of our December 2021 Notes and our December
2024 Notes that may affect the value of our common stock and any desired dilution mitigation will be limited to the extent
that our stock price rises above the cap price of the applicable capped call transactions.
In connection with the issuance of our December 2021 Notes and our December 2024 Notes, we entered into capped call
transactions, with hedge counterparties, which we expect to reduce the potential dilution upon conversion of the December 2021
Notes and the December 2024 Notes in the event that the market price per share of our common stock, as measured under the
terms of the applicable capped call transaction, at the time of exercise is greater than the strike price of the applicable capped call
transaction, which corresponds to the initial conversion price of the applicable notes and is subject to certain adjustments similar
to those contained in the applicable notes. If, however, the market price per share of our common stock, as measured under the
terms of the applicable capped call transaction, exceeds the cap price of the applicable capped call transaction, there would
nevertheless be dilution to the extent that such market price exceeds the cap price of the applicable capped call transaction.
In connection with hedging the capped call transactions, the hedge counterparties or their affiliates:
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expect to purchase our common stock in the open market and/or enter into various derivatives and/or enter into
various derivative transactions with respect to our common stock; and
may enter into or unwind various derivatives and/or purchase or sell our common stock in secondary market
transactions.
These activities could have the effect of increasing or preventing a decline in the price of our common stock concurrently with or
following the pricing of the applicable notes and could have the effect of decreasing the price of our common stock during the
period immediately prior to a conversion of the applicable notes.
The hedge counterparties or their affiliates are likely to modify their hedge positions in relation to the capped call transactions
from time to time prior to conversion or maturity of the applicable notes by purchasing and selling our common stock, other of
our securities, or other instruments they may wish to use in connection with such hedging.
In addition, we intend to exercise options we hold under the capped call transaction whenever the notes are converted. In order to
unwind its hedge positions with respect to those exercised options, the counterparties or affiliates thereof expect to sell our
common stock in secondary market transactions or unwind various derivative transactions with respect to our common stock
during the period immediately prior to conversion of the applicable notes. We have also agreed to indemnify the hedge
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counterparties and affiliates thereof for losses incurred in connection with a potential unwinding of their hedge positions under
certain circumstances.
The effect, if any, of any of these transactions and activities on the market price of our common stock will depend in part on
market conditions and cannot be ascertained at this time, but any of these activities could adversely affect the value of our
common stock. For further information regarding the mechanics of our capped call transactions, refer to our discussion in Note
13, Convertible Senior Notes, to the Consolidated Financial Statements.
We have implemented a corporate structure taking into consideration our limited operations and potentially applicable
tax impact on our royalty and other income, and any changes in applicable tax laws and regulations or enforcement
positions of tax authorities may negatively impact our financial condition and operating results.
We have established our corporate structure to be closely aligned with the financial nature of our business. There can be no
assurance that the applicable tax laws and regulations will continue in effect or that the taxing authorities in any or all of the
applicable jurisdictions will not challenge one or more aspects or characterizations of our corporate structure and the treatment of
transactions or agreements within our corporate structure, or determine that the manner in which we operate our business is not
consistent with our corporate structure. For example, recently enacted U.S. tax legislation may result in an increased tax liability
as a result of our current corporate structure. We may also have disputes with one or more state tax authorities regarding whether
we are subject to that state’s tax and, if we are subject to such state’s tax, what proportion of our revenues is subject to taxation in
such state. For example, we are currently subject to an audit by the California Franchise Tax Board and, while we may disagree
with their conclusions regarding such issues, the proceedings may extend over a long period of time and we may ultimately be
required to pay taxes either in a settlement or upon a final decision of an agency or court. In addition, an inability to resolve our
audit with the Franchise Tax Board in a satisfactory manner without extensive legal proceedings may result in an extended period
of operation prior to wind-down or dissolution. Any unfavorable changes in laws and regulations or positions by tax authorities
could harm our financial position, results of operations and cash flows.
We may have exposure to additional tax liabilities.
We are subject to taxes in the United States and other jurisdictions. Tax rates in these jurisdictions may be subject to significant
change due to economic and/or political conditions. A number of other factors may also impact our future effective tax rate
including:
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the jurisdictions in which profits are determined to be earned and taxed;
the resolution of issues arising from tax audits with various tax authorities;
changes in valuation of our deferred tax assets and liabilities;
increases in expenses not deductible for tax purposes, including write-offs of acquired intangibles and impairment of
goodwill in connection with acquisitions;
changes in availability of tax credits, tax holidays, and tax deductions;
changes in share-based compensation; and
changes in tax laws or the interpretation of such tax laws and changes in generally accepted accounting principles.
On December 22, 2017, the U.S. federal government enacted the 2017 Tax Act. The 2017 Tax Act significantly changed the
existing U.S. corporate income tax laws by, among other things, lowering the corporate tax rate (from a top rate of 35% to a flat
rate of 21%), implementing elements of a territorial tax system, and imposing a one-time deemed repatriation transition tax on
cumulative undistributed foreign earnings, for which we have not previously paid U.S. taxes. The Company recognized in its
Consolidated Financial Statements for the year ended December 31, 2017 estimated tax impacts related to the revaluation of
deferred tax assets and liabilities. The ultimate impact did not differ materially from these provisional amounts after additional
analysis, changes in interpretations and assumptions the Company made and additional regulatory guidance that was issued. The
accounting was completed when the Company’s 2017 U.S. corporate income tax return was filed in 2018. We have made a policy
election with respect to our treatment of potential GILTI to account for taxes on GILTI as a current-period expense as incurred.
In addition, certain activities conducted by our foreign subsidiaries may give rise to United States corporate income tax, even if
there are no distributions to the United States. These taxes would be imposed on us when our subsidiaries that are controlled
foreign corporations generate income that is subject to Subpart F of the U.S. Internal Revenue Code (“Subpart F”) or Global
intangible low-taxed income (“GILTI”). Passive income, such as rents, royalties, interest and dividends, is among the types of
income subject to taxation under Subpart F. Any income taxable under Subpart F or GILTI is taxable in the United States at
federal corporate income tax rates of 21%. Subpart F income that is taxable to us, even if it is not distributed to us, may also
include income from intercompany transactions between our U.S. and non-U.S. subsidiaries, or where our non-U.S. subsidiaries
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make an “investment in U.S. property,” within the meaning of Subpart F, such as holding the stock in, or making a loan to, a U.S.
corporation.
While we may mitigate this increase in our effective tax rate through claiming a foreign tax credit against our U.S. federal income
taxes or potentially have foreign or U.S. taxes reduced under applicable income tax treaties, we are subject to various limitations
on claiming foreign tax credits and we may lack treaty protections in certain jurisdictions that will potentially limit any reduction
of the increased effective tax rate. A higher effective tax rate may also result to the extent that losses are incurred in non-U.S.
subsidiaries that do not reduce our U.S. taxable income.
Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
At December 31, 2019, we had federal, state and foreign net operating loss carryforwards of $108.6 million, $63.9 million and
$125.6 million, respectively, and federal and state tax credit carryforwards of $2.2 million and $19.3 million, respectively. There
may be limitations on our ability to use our net operating loss carryforwards or other tax assets. For example, under Section 382
of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change” (generally defined as a
greater than 50% change (by value) in its equity ownership over a three-year period), the corporation’s ability to use its pre-
change net operating loss carryforwards and other pre-change tax attributes to offset its post-change income may be limited. We
or our subsidiaries may have experienced, or may in the future experience, “ownership changes” as a result of shifts in stock
ownership. Tax attributes acquired from LENSAR may be subject to separate return limitations that may limit the corporation’s
ability to use the acquired net operating losses and credits. Any limitations on our ability to use our net operating loss
carryforwards and other tax assets could materially and adversely impact our financial condition and results of operations.
Furthermore, under the 2017 Tax Act, although the treatment of tax losses generated in taxable years ending before December 31,
2017 has generally not changed, tax losses generated in taxable years beginning after December 31, 2017 may only be utilized to
offset 80% of taxable income annually. This change may require us to pay additional federal income taxes in future years.
We depend on our licensees and royalty-agreement counterparties for the determination of royalty payments. While we
have rights to audit our licensees and royalty-agreement counterparties, the independent auditors may have difficulty
determining the correct royalty calculation, we may not be able to detect errors and payment calculations may call for
retroactive adjustments. We may have to exercise legal remedies to resolve any disputes resulting from the audit or
otherwise related to non-performance by a licensee or royalty counterparty.
The royalty payments we receive are determined by our licensees based on their reported sales. Each licensee’s calculation of the
royalty payments is subject to and dependent upon the adequacy and accuracy of its sales and accounting functions, and errors
may occur from time to time in the calculations made by a licensee. Our license and royalty agreements provide us the right to
audit the calculations and sales data for the associated royalty payments; however, our right to conduct such audits may be limited
in terms of the covered periods, and such audits may occur many months following our recognition of the royalty revenue, may
require us to adjust our royalty revenues in later periods and may require incurring additional expenses on our part. Further, our
licensees and royalty-agreement counterparties may be uncooperative or have insufficient records, which may complicate and
delay the audit process.
Although we regularly exercise our royalty audit rights, and reference publicly available information in the assessment of the paid
royalties, we rely in the first instance on our licensees and royalty-agreement counterparties to accurately report sales and
calculate and pay applicable royalties and, upon exercise of such royalty audit rights, we rely on licensees’ and royalty-agreement
counterparties’ cooperation in performing such audits. In the absence of such cooperation, we may be forced to exercise legal
remedies to enforce our agreements.
We may experience increases and decreases in our revenues due to fluctuations in foreign currency exchange rates and we
may be unsuccessful in our attempts to mitigate this risk.
Our operating results are subject to volatility due to fluctuations in foreign currency exchange rates. Our primary exposure to
fluctuations in foreign currency exchange rates relates to revenue and operating expenses denominated in currencies other than
the U.S. dollar. Fluctuations in foreign currency rates, particularly the Euro, relative to the U.S. dollar can significantly affect our
revenues and operating results. While foreign currency conversion terms vary by license agreement, generally most agreements
require that royalties first be calculated in the currency of sale and then converted into U.S. dollars using the average daily
exchange rates for that currency for a specified period at the end of the calendar quarter. For example, when the U.S. dollar
weakens in relation to other currencies, the converted amount is greater than it would have been had the U.S. dollar exchange
rates remained unchanged. Our revenues may fluctuate due to changes in foreign currency exchange rates and is subject to foreign
currency exchange risk.
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To compensate for Euro currency fluctuations, we may hedge Euro currency exposures with Euro forward and option contracts, to
offset the risks associated with these Euro currency exposures. We may suspend the use of these contracts from time to time or we
may be unsuccessful in our attempt to hedge our Euro currency risk. We will continue to experience foreign currency related
fluctuations in our royalty revenues in certain instances when we do not enter into foreign currency exchange contracts or where it
is not possible or cost effective to hedge our foreign currency related exposures. Currency related fluctuations in our royalty
revenues will vary based on the currency exchange rates associated with these exposures and changes in those rates, whether we
have entered into foreign currency exchange contracts to offset these exposures and other factors. All of these factors could
materially impact our results of operations, financial position and cash flows, the timing of which is variable and generally outside
of our control.
Legislative or regulatory reforms in the United States or the EU may make it more difficult and costly for us to obtain
regulatory clearances or approvals for our medical device products or to manufacture, market or distribute our products
after clearance or approval is obtained.
From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions
governing the regulation of medical devices. In addition, the FDA may change its clearance and approval policies, adopt
additional regulations or revise existing regulations, or take other actions, which may prevent or delay approval or clearance of
our future products under development or impact our ability to modify our currently cleared products on a timely basis. Over the
last several years, the FDA has proposed reforms to its 510(k) clearance process, and such proposals could include increased
requirements for clinical data and a longer review period, or could make it more difficult for manufacturers to utilize the 510(k)
clearance process for their products. For example, in November 2018, FDA officials announced forthcoming steps that the FDA
intends to take to modernize the premarket notification pathway under Section 510(k) of the FFDCA. Among other things, the
FDA announced that it planned to develop proposals to drive manufacturers utilizing the 510(k) pathway toward the use of newer
predicates. These proposals included plans to potentially sunset certain older devices that were used as predicates under the
510(k) clearance pathway, and to potentially publish a list of devices that have been cleared on the basis of demonstrated
substantial equivalence to predicate devices that are more than 10 years old. In May 2019, the FDA solicited public feedback on
these proposals. These proposals have not yet been finalized or adopted, and the FDA may work with Congress to implement such
proposals through legislation. Accordingly, it is unclear the extent to which any proposals, if adopted, could impose additional
regulatory requirements on us that could delay our ability to obtain new 510(k) clearances, increase the costs of compliance, or
restrict our ability to maintain our current clearances, or otherwise create competition that may negatively affect our business or
monetization strategy.
More recently, in September 2019, the FDA finalized guidance describing an optional “safety and performance based” premarket
review pathway for manufacturers of “certain, well-understood device types” to demonstrate substantial equivalence under the
510(k) clearance pathway by showing that such device meets objective safety and performance criteria established by the FDA,
thereby obviating the need for manufacturers to compare the safety and performance of their medical devices to specific predicate
devices in the clearance process. The FDA intends to develop and maintain a list of device types appropriate for the “safety and
performance based” pathway and will continue to develop product-specific guidance documents that identify the performance
criteria for each such device type, as well as the testing methods recommended in the guidance documents, where feasible. The
FDA may establish performance criteria for classes of devices for which we or our competitors seek or currently have received
clearance, and it is unclear the extent to which such performance standards, if established, could impact our ability to obtain new
510(k) clearances or otherwise create competition that may negatively affect our business or monetization strategy.
In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our
business and our products. Any new statutes, regulations or revisions or reinterpretations of existing regulations may impose
additional costs or lengthen review times of any future products or make it more difficult to obtain clearance or approval for,
manufacture, market or distribute our products. We cannot determine what effect changes in regulations, statutes, legal
interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the future. Such changes
could, among other things, require: additional testing prior to obtaining clearance or approval; changes to manufacturing methods;
recall, replacement or discontinuance of our products; or additional record keeping.
On April 5, 2017, the European Parliament passed the Medical Devices Regulation (Regulation 2017/745), which repeals and
replaces the EU Medical Devices Directive and the Active Implantable Medical Devices Directive. Unlike directives, which must
be implemented into the national laws of the EEA member states, the regulations would be directly applicable, i.e., without the
need for adoption of EEA member state laws implementing them, in all EEA member states and are intended to eliminate current
differences in the regulation of medical devices among EEA member States. The Medical Devices Regulation, among other
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things, is intended to establish a uniform, transparent, predictable and sustainable regulatory framework across the EEA for
medical devices and ensure a high level of safety and health while supporting innovation.
The Medical Devices Regulation will, however, only become applicable three years after publication (in 2020). Once applicable,
the new regulations will among other things:
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strengthen the rules on placing devices on the market and reinforce surveillance once they are available;
establish explicit provisions on manufacturers’ responsibilities for the follow up of the quality, performance and safety of
devices placed on the market;
improve the traceability of medical devices throughout the supply chain to the end user or patient through a unique
identification number;
set up a central database to provide patients, healthcare professionals and the public with comprehensive information on
products available in the EU;
strengthened rules for the assessment of certain high risk devices, such as implants, which may have to undergo an
additional check by experts before they are placed on the market.
These modifications may have an effect on the way we conduct our business in the EEA.
Our agreements with Facet may not reflect terms that would have resulted from arm’s-length negotiations between
unaffiliated third parties.
The agreements associated with the spin-off of Facet in December 2008 (the “Spin-Off”), including the Separation and
Distribution Agreement, Tax Sharing and Indemnification Agreement and Cross License Agreement, were negotiated in the
context of the Spin-Off while Facet was still part of us and, accordingly, may not reflect more favorable terms that may have
resulted from arm’s-length negotiations between unaffiliated third parties.
We may have obligations for which we may not be able to collect under our indemnification rights from Facet.
Under the terms of the Separation and Distribution agreement with Facet, we and Facet agreed to indemnify the other from and
after the Spin-Off with respect to certain indebtedness, liabilities and obligations that were retained by our respective
companies. These indemnification obligations could be significant. The ability to satisfy these indemnities, if called upon to do so,
will depend upon our future financial strength. We cannot assure you that, if Facet has to indemnify us for any substantial
obligations, Facet will have the ability to satisfy those obligations. If Facet does not have the ability to satisfy those obligations,
we may be required to satisfy those obligations instead. For example, in connection with the Spin-Off, we entered into
amendments to the leases for the facilities in Redwood City, California, which formerly served as our corporate headquarters,
under which Facet was added as a co-tenant under the leases and a Co-Tenancy Agreement under which Facet agreed to
indemnify us for all matters related to the leases attributable to the period after the Spin-Off date. Should Facet default under its
lease obligations, we would be held liable by the landlord as a co-tenant and, thus, we have in substance guaranteed the payments
under the lease agreements for the Redwood City facilities, the disposition of which could have a material adverse effect on the
amount or timing of any distribution to our stockholders. As of December 31, 2019, the total lease payments for the duration of
the guarantee, which runs through December 2021, are approximately $22.6 million. We would also be responsible for lease-
related payments including utilities, property taxes and common area maintenance that may be as much as the actual lease
payments. In April 2010, Abbott Laboratories acquired Facet and renamed the company Abbott Biotherapeutics Corp., and in
January 2013, Abbott Biotherapeutics Corp. was renamed AbbVie Biotherapeutics, Inc. and spun off from Abbott as a subsidiary
of AbbVie Inc. We do not know how Abbott’s acquisition of Facet will impact our ability to collect under our indemnification
rights or whether Facet’s ability to satisfy its obligations will change. In addition, we have limited information rights under the
Co-Tenancy Agreement. As a result, we are unable to determine definitively whether Facet continues to occupy the space and
whether it has subleased the space to another party or the basis upon which our potential co-tenant obligation may be triggered.
See “Item 2-Properties.”
As we continue to operate our business and as we implement our monetization strategy, our mix of assets and sources of
income may require that we register with the SEC as an “investment company” in accordance with the Investment
Company Act of 1940.
We are not registered and have no intention to register as an “investment company” under the Investment Company Act of 1940
(the “40 Act”). As a result, we are not and do not expect to become subject to regulation under the 40 Act, including its reporting
and corporate governance requirements and restrictions on leverage and affiliate transactions.
51
Generally, to avoid being regulated as an “investment company” under the 40 Act an issuer must:
•
•
not be engaged or hold itself out as being engaged primarily in the business of investing, reinvesting or trading in
securities and not own or propose to acquire “investment securities” with a value of more than 40% of the value of its
total assets (exclusive of U.S. government securities and cash items) on an unconsolidated basis; or
be able to rely on an exception from the definition of “investment company” under the ’40 Act or an exemptive rule.
“Investment securities” are any securities other than U.S. government securities and securities issued by a majority-owned
subsidiary that is not itself either an “investment company” or a private investment company, meaning a company that is excluded
from the definition of “investment company” by Section 3(c)(1) or Section 3(c)(7) of the 40 Act.
We have in the past and may in the future rely on one or more exceptions to the definition of “investment company” under the 40
Act, including the exception under Section 3(c)(5) of the 40 Act. To rely on Section 3(c)(5), as interpreted by the staff of the SEC,
we would be required to have at least 55% of our total assets in certain qualifying assets. In a no-action letter issued to Royalty
Pharma on August 13, 2010, the SEC staff stated that certain royalty interests of the type we own can be treated as qualifying
assets.
Ensuring that we do not fall within the definition of “investment company” under the 40 Act may limit our ability to make certain
investments (including divesting certain assets), or require us to take or forego certain actions, that could materially and adversely
affect our financial condition and results of operation. In addition, if the SEC, its staff or the courts changes their interpretation of
certain provisions of the 40 Act, including Section 3(c)(5), we may need to take additional steps in order to avoid becoming
subject to regulation under the 40 Act, which could materially and adversely affect our financial condition and results of
operation.
If we were required to register as an “investment company,” the obligations imposed on us by the 40 Act would likely require
substantial changes in the way we do business and would result in significant additional regulatory and administrative burdens
and costs. In order to remain outside the scope of regulation under the 40 Act, we may need to take various actions which we
might otherwise not pursue. These actions may include restructuring our company and modifying our mixture of assets and
income, including divesting certain desirable assets immediately, and could have a material and adverse effect on us.
Failure in our information technology and storage systems could significantly disrupt the operation of our business.
Our ability to execute our business plan depends, in part, on the continued and uninterrupted performance of our information
technology (“IT”) systems. IT systems are vulnerable to damage from a variety of sources, including telecommunications or
network failures, malicious human acts and natural disasters. Moreover, despite network security and back-up measures, some of
our servers may be vulnerable to physical or electronic break-ins, computer viruses and similar disruptive problems. Despite the
precautionary measures we have taken to prevent unanticipated problems that could affect our IT systems, sustained or repeated
system failures that interrupt our ability to generate and maintain data could adversely affect our ability to operate our business.
Changes to financial accounting standards may affect our reported results of operations.
A change in accounting standards or practices can have a significant effect on our reported results and may even affect our
reporting of transactions completed before the change is effective. New accounting pronouncements and varying interpretations of
accounting pronouncements have occurred and may occur in the future. Changes to existing standards or the reevaluation of
current practices may adversely affect our reported financial results or the way we conduct our business.
We use estimates, make judgments, and apply certain methods in measuring the progress of our business in determining
our financial results and in applying our accounting policies. As these estimates, judgments, and methods change, our
assessment of the progress of our business and our results of operations could vary.
The methods, estimates, and judgments we use in applying our accounting policies have a significant impact on our results of
operations. Such methods, estimates, and judgments are, by their nature, subject to substantial risks, uncertainties, and
assumptions, and factors may arise over time may lead us to change our methods, estimates, and judgments. Changes in any of
our assumptions may adversely affect our reported financial results.
If we fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to
accurately report our financial condition, results of operations or cash flows, which may adversely affect investor
confidence in us and, as a result, the value of our common stock.
52
The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal controls for financial reporting and
disclosure controls and procedures. We are required, under Section 404 of the Sarbanes-Oxley Act (“Section 404”), to furnish a
report by management on, among other things, the effectiveness of our internal control over financial reporting. This assessment
must include disclosure of any material weaknesses identified by our management in our internal control over financial
reporting. A material weakness is a control deficiency, or combination of control deficiencies, in internal control over financial
reporting that results in more than a reasonable possibility that a material misstatement of annual or interim financial statements
will not be prevented or detected on a timely basis. Section 404 also generally requires an attestation from our independent
registered public accounting firm on the effectiveness of our internal control over financial reporting.
Our compliance with Section 404 requires that we incur substantial accounting expense and expend significant management
efforts. Our acquired businesses may have limited experience complying with Section 404 and if in the future we identify one or
more material weaknesses in our internal control over financial reporting, we will be unable to assert that our internal control over
financial reporting is effective. Furthermore, we cannot assure you that there will not be material weaknesses or significant
deficiencies in our internal control over financial reporting in the future. Any failure to maintain internal control over financial
reporting could severely inhibit our ability to accurately report our financial condition, results of operations or cash flows. If our
independent registered public accounting firm determines we have a material weakness or significant deficiency in our internal
control over financial reporting, we could lose investor confidence in the accuracy and completeness of our financial reports, the
market price of our common stock could decline, and we could be subject to sanctions or investigations by Nasdaq, the SEC or
other regulatory authorities. Failure to remedy any material weakness in our internal control over financial reporting, or to
implement or maintain other effective control systems required of public companies, could also restrict our future access to the
capital markets.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 2. PROPERTIES
Medical Devices Segment
LENSAR leases an office and manufacturing facility of approximately 33,900 square feet in Orlando, Florida, which serves as the
office managing all medical device operations. The lease expires in July 2021.
Pharmaceutical Segment
Noden Pharma DAC leases approximately 3,100 square feet of office space in Dublin, Ireland, which serves as the office
managing all pharmaceutical operations. The lease expires in September 2025. Noden Pharma DAC has the option to terminate
the lease in September 2021.
Income Generating Assets Segment
We lease approximately 5,900 square feet of office space in Incline Village, Nevada, which serves as our corporate headquarters.
The lease expires in May 2022.
In July 2006, we entered into two leases and a sublease for facilities in Redwood City, California, which formerly served as our
corporate headquarters and cover approximately 450,000 square feet of office space. Under the amendments to the leases entered
into in connection with the Spin-Off, Facet was added as a co-tenant under the leases. As a co-tenant, Facet is bound by all of the
terms and conditions of the leases. We and Facet are jointly and severally liable for all obligations under the leases, including the
payment of rental obligations. The guarantee runs through December 2021. We also entered into a Co-Tenancy Agreement with
Facet in connection with the Spin-Off and the lease amendments under which we assigned to Facet all rights under the leases,
including, but not limited to, the right to amend the leases, extend the lease terms or terminate the leases, and Facet assumed all of
our obligations under the leases. Under the Co-Tenancy Agreement, we also relinquished any right or option to regain possession,
use or occupancy of these facilities. Facet agreed to indemnify us for all matters associated with the leases attributable to the
period after the Spin-Off date and we agreed to indemnify Facet for all matters associated with the leases attributable to the period
before the Spin-Off date. In addition, in connection with the Spin-Off, we assigned the sublease to Facet. In April 2010, Abbott
Laboratories acquired Facet and later renamed the entity AbbVie Biotherapeutics, Inc. (“AbbVie”). To date, AbbVie has satisfied
all obligations under the Redwood City leases.
53
We believe that our existing facilities are adequate to meet our business requirements for the reasonably foreseeable future and
that additional space will be available on commercially reasonable terms, if required.
ITEM 3. LEGAL PROCEEDINGS
The information set forth in Note 25, Legal Proceedings, to the Consolidated Financial Statements included in Item 8, “Financial
Statements and Supplementary Data” of this Annual Report is incorporated by reference herein.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
54
PART II
ITEM 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS
AND ISSUER PURCHASES OF EQUITY SECURITIES
As of February 28, 2020, we had approximately 120 common stockholders of record. Most of our outstanding shares of common
stock are held of record by one stockholder, Cede & Co., as nominee for the Depository Trust Company. Many brokers, banks and
other institutions hold shares of common stock as nominees for beneficial owners that deposit these shares of common stock in
participant accounts at the Depository Trust Company. The actual number of beneficial owners of our stock is likely significantly
greater than the number of stockholders of record; however, we are unable to reasonably estimate the total number of beneficial
owners.
Equity Compensation Plan Information
See Part III, Item 12, “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters” for
information regarding securities authorized for issuance under equity compensation plans.
Recent Sales of Unregistered Securities
On September 12, 2019, we entered into separate, privately negotiated agreements with a limited number of holders of our 2.75%
Convertible Senior Notes due 2021 (the “December 2021 Notes”) to exchange an aggregate of approximately $86.1 million
principal amount of the 2021 Notes for (i) an aggregate of approximately $86.1 million original principal amount of new 2.75%
Convertible Senior Notes due 2024 (the “December 2024 Notes” or the “Exchanged Notes”) and (ii) an aggregate of $6.0 million
in cash (such transactions, collectively, the “September Exchange”).
The 2024 Notes were issued in private placements exempt from registration in reliance on Section 4(a)(2) of the Securities Act of
1933, as amended (the “Securities Act”). We did not receive any cash proceeds from the issuance of the 2024 Notes. In
connection with the September Exchange, we entered into a capped call transaction with Royal Bank of Canada (“RBC”). The
capped call transaction covers, subject to customary anti-dilution adjustments, the number of shares of our common stock that
will initially underlie the Exchange Notes. The capped call transaction is intended to reduce the dilutive impact of the conversion
feature of the Exchange Notes on the Company’s outstanding shares of common stock and/or offset any cash payments the
Company will be required to make in excess of the original principal amount upon any conversion of the Exchange Notes, with
such offset subject to a cap. In connection with the September Exchange, we also entered into an unwind agreement with RBC in
order to partially unwind the previous capped call transaction entered into by the Company related to the 2021 Notes that were
exchanged.
On December 12, 2019, we entered into separate, privately negotiated exchange agreements pursuant to which we repurchased
$119.3 million in aggregate principal amount of our December 2021 and December 2024 convertible notes for (i) $97.9 million
excluding accrued and unpaid interest and (ii) 13.4 million shares of our common stock in exchange for $44.8 million in
aggregate principal amount of our outstanding December 2021 Notes and $74.6 million in aggregate principal amount of our
outstanding December 2024 Notes (the “December Exchange”). The issuance of shares of common stock was exempt from
registration in reliance on Section 3(a)(9) of the Securities Act of 1933, as amended.
Issuer purchases of Equity Securities
On December 9, 2019, we announced that our board of directors authorized the repurchase of issued and outstanding shares of our
common stock and convertible notes up to an aggregate value of $200.0 million pursuant to a repurchase program. Repurchases
under the new repurchase program will be made from time to time in the open market or in privately negotiated transactions and
funded from our working capital. The amount and timing of repurchases of shares of our common stock or convertible notes will
depend upon the price and availability of shares, general market conditions and the availability of cash. Repurchases may also be
made under a trading plan under Rule 10b5-1, which would permit shares or convertible notes to be repurchased when we might
otherwise be precluded from doing so because of self-imposed trading blackout periods or other regulatory restrictions. All shares
of common stock repurchased under the share repurchase program are expected to be retired and restored to authorized but
unissued shares of common stock. All convertible notes repurchased under the program will be retired. This repurchase program
may be suspended or discontinued at any time without notice. On December 16, 2019, we announced that our board of directors
approved a $75.0 million increase to the previous $200.0 million repurchase program to acquire outstanding common stock and
convertible notes.
55
In connection with the December Exchange, we unwound a pro rata portion of the capped call transactions we entered into with
the issuance of the December 2021 Notes and the December 2024 Notes. We received cash proceeds from RBC of $6.7 million as
a result of the partial unwinding of the capped call agreements. Pursuant to the partial unwinding of the capped call agreements,
we entered into an agreement with RBC to purchase 3.2 million shares of our common stock previously acquired by RBC to
hedge the capped calls. We acquired the common stock at its closing price on December 12, 2019.
The following table contains information relating to the repurchases of our common stock made by us in the three months ended
December 31, 2019 (in thousands, except per share amounts):
Fiscal Period
October 1, 2019
to October 31, 2019 ........
November 1, 2019 to November 30, 2019 ....
December 1, 2019 to December 31, 2019.....
Total during three months ended December 31,
2019....................................................................
Total
Number of
Shares
Repurchased
Average
Price
Paid Per
Share
—
$
—
$
3,209 (1) $
—
—
3.43
3,209
$
3.43
Total Number of
Shares Purchased
As Part of a
Publicly
Announced
Program
Approximate
Dollar Amount of
Shares That May
Yet be Purchased
Under the
Program
— $
— $
3,209
3,209
$
$
—
—
120,204 (2)
120,204
________________
(1) Purchases in December 2019 were made pursuant to capped call options the Company entered into in connection with
the issuance of the December 2021 Notes and the December 2024 Notes. For additional information on the capped
call transactions, see Note 13, Convertible Notes.
(2) The approximate dollar amount of shares that may yet be purchased under the share repurchase program was reduced
by the cash and PDL common stock issued as consideration to repurchase the convertible notes in December 2019.
56
Comparison of Stockholder Returns
The line graph below compares the cumulative total stockholder return on our common stock between December 31, 2014, and
December 31, 2019, with the cumulative total return of (i) the Nasdaq Biotechnology Index and (ii) the Nasdaq Composite Index
over the same period. This graph assumes that $100.00 was invested on December 31, 2014, in our common stock at the closing
sales price for our common stock on that date and at the closing sales price for each index on that date and that all dividends were
reinvested. Stockholder returns over the indicated period should not be considered indicative of future stockholder returns and are
not intended to be a forecast.
PDL BioPharma, Inc.................... $
Nasdaq Composite Index............. $
Nasdaq Biotechnology Index ...... $
12/31/2014
100.00
12/31/2015
50.20
$
12/31/2016
30.98
$
12/31/2017
40.04
$
12/31/2018
42.38
$
12/31/2019
48.55
$
100.00
100.00
$
$
140.56
122.81
$
$
112.25
133.19
$
$
133.67
172.11
$
$
121.24
165.84
$
$
200.49
121.92
The information in this section shall not be deemed to be “soliciting material” or to be “filed” with the SEC, nor shall such
information be incorporated by reference into any future filing under the Securities Act of 1933, as amended, or the Securities
Exchange Act of 1934, as amended, except to the extent that we specifically incorporate it by reference in such filing.
57
ITEM 6. SELECTED CONSOLIDATED FINANCIAL DATA
This section of the Company's Annual Report on Form 10-K has been superseded by the section titled “ITEM 6. SELECTED
CONSOLIDATED FINANCIAL DATA” in Exhibit 99.1 of the Form 8-K filed by the Company on June 30, 2020 and
included in this 2019 Annual Report after the Annual Report on Form 10-K. Please refer to the Form 8-K for this information.
58
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
This section of the Company's Annual Report on Form 10-K has been superseded by the section titled “ITEM 7.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS” in
Exhibit 99.1 of the Form 8-K filed by the Company on June 30, 2020 and included in this 2019 Annual Report after the Annual
Report on Form 10-K. Please refer to the Form 8-K for this information.
60
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Interest Rate Sensitive Financial Instruments
Our exposure to market risk for changes in interest rates relates primarily to our excess cash investments and our convertible
notes.
Our excess cash investments consist of Rule 2a-7 money market funds and had a fair value of approximately $131.3 million at
December 31, 2019 and $226.7 million at December 31, 2018. Due to the short duration of these investments, with a maximum
weighted average maturity of 60 days or less, if market interest rates were to increase or decrease by 1%, there would be no
material impact on the fair value of our portfolio.
The aggregate fair value of our convertible notes was estimated to be $33.9 million at December 31, 2019, and $151.4 million at
December 31, 2018, based on available pricing information. At December 31, 2019 our convertible notes consisted of the
December 2021 Notes, and the December 2024 Notes, both of which have a fixed interest rate of 2.75%, and also for the
December 2024 Notes, a principal accretion rate of 2.375% per year. As of December 31, 2018, our convertible notes consisted of
the December 2021 Notes. Changes in interest rates do not affect interest expense on fixed rate debt. While changes in interest
rates do not impact the amount of interest we pay, these obligations are subject to interest rate risk because changes in interest
rates would affect the fair values of fixed rate debt.
The following table presents information about our material debt obligation that is sensitive to changes in interest rates. The table
presents principal amounts and related interest rates by year of expected maturity for our debt obligations or the earliest year in
which the holders may put the debt to us. The convertible notes may be converted to our common stock prior to the maturity date
under certain conditions.
(in thousands)
Convertible notes
Fixed Rate ....................
Average Interest Rate ...
2020
2021
2022
2023
2024
Total
Fair Value
$
— $ 19,170
$
— $
— $ 11,500
$
30,670
$
33,931 (1)
3.64%
3.69%
5.13%
5.13%
5.13%
_________________________
(1) The fair value of the remaining payments under our December 2021 Notes and December 2024 Notes was estimated based on
the trading value of these notes at December 31, 2019.
Equity Price Risk
Our investments in equity securities expose us to equity price risk. Equity price risk results from fluctuations in quoted market
prices for equity securities and instruments that derive their value from such securities. The fair value of our investments that are
subject to equity price risk as of December 31, 2019 was approximately $96.4 million. The impact of a 10% decrease in the
quoted market price related to these investments would have been approximately a $10.0 million decrease to pre-tax income. Due
to equity securities being measured at fair value with net unrealized gains and losses from changes in the fair value recognized in
earnings, fluctuations in quoted market prices for equity securities could have a material effect on our results of operations and
our financial position.
76
Foreign Currency Sensitive Financial Instruments
Our international operations are affected by fluctuations in the value of the U.S. dollar as compared to foreign currencies,
predominantly the euro. Increases and decreases in our international product sales from movements in foreign currency exchange
rates are offset partially by the corresponding increases or decreases in our international operating expenses. Our revenues,
expenses and cash flows may fluctuate due to changes in foreign currency exchange rates and are subject to foreign currency
exchange risk. While foreign currency conversion terms vary by agreement, generally most agreements require that royalties first
be calculated in the currency of sale and then converted into U.S. dollars using the average daily exchange rates for that currency
for a specified period at the end of the calendar quarter. Similarly, sales outside of the United States of our Noden Products as well
as a portion of the cash balances and expenses of our Irish subsidiary are denominated in currencies other than the U.S. dollar.
Accordingly, when the U.S. dollar weakens against other currencies, the converted amount is greater than it would have been had
the U.S. dollar not weakened and when the U.S. dollar strengthens against other currencies, the converted amount is less.
77
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
This section of the Company's Annual Report on Form 10-K has been superseded by the section titled “ITEM 8. FINANCIAL
STATEMENTS AND SUPPLEMENTARY DATA” in Exhibit 99.1 of the Form 8-K filed by the Company on June 30, 2020
and included in this 2019 Annual Report after the Annual Report on Form 10-K. Please refer to the Form 8-K for this
information.
78
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
The Company’s management has evaluated, with the participation of the chief executive officer and the chief financial officer, the
effectiveness of the Company’s disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the
Securities Exchange Act of 1934 (Exchange Act)) as of the end of the period covered by this report. Based on this evaluation,
management concluded that the Company’s disclosure controls and procedures were effective as of December 31, 2019.
Management’s Report on Internal Control over Financial Reporting
The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting, as
defined in the Exchange Act Rules 13a-15(f) and 15d-15(f). The Company’s management, including the chief executive officer and
chief financial officer, conducted an evaluation of the effectiveness of the Company’s internal control over financial reporting based
on the Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway
Commission (COSO). Based on the results of this evaluation, the Company’s management concluded that internal control over
financial reporting was effective as of December 31, 2019.
The effectiveness of the Company’s internal control over financial reporting as of December 31, 2019, has been audited by
PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in its report included herein.
Changes in Internal Control over Financial Reporting
During the quarter ended December 31, 2019, there were no changes in the Company’s internal control over financial reporting
that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
Not applicable.
144
PART III
Certain information required by Part III is omitted from this Annual Report on Form 10-K and is incorporated herein by reference
to our definitive Proxy Statement for our 2019 Annual Meeting of Stockholders (the “Proxy Statement”), which we intend to file
pursuant to Regulation 14A of the Securities Exchange Act of 1934, as amended, within 120 days after December 31, 2019.
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this Item 10 will be contained in the Proxy Statement and is incorporated herein by reference.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this Item 11 will be contained in the Proxy Statement and is incorporated herein by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
RELATED STOCKHOLDER MATTERS
The information required by this Item 12 will be contained in the Proxy Statement and is incorporated herein by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by this Item 13 will be contained in the Proxy Statement and is incorporated herein by reference.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The information required by this Item 14 will be contained in the Proxy Statement and is incorporated herein by reference.
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) The following documents are filed as part of this Annual Report on Form 10-K:
PART IV
(1) Financial Statements - See Index to Consolidated Financial Statements at Item 8 of this Annual Report on
Form 10-K.
(2) Financial Statement Schedules
The financial statement schedules are omitted because the information is not applicable, not required under the
instructions, or the information requested is set forth in our Consolidated Financial Statements or related notes thereto.
(3) Exhibits required by Item 601 of Regulation S-K
The information required by this Section (a)(3) of Item 15 is set forth on the exhibit index that precedes the Signatures
page of this Annual Report on Form 10-K.
ITEM 16. FORM 10-K SUMMARY
None.
145
Exhibit
Number
EXHIBIT INDEX
Exhibit Title
2.1
2.2
3.1
3.2
3.3
3.4
3.5
3.6
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8#
10.1*
10.2*
10.3*
Separation and Distribution Agreement, dated December 17, 2008, between the Company and Facet Biotech
Corporation (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed December 23,
2008)
Amendment No. 1 to Separation and Distribution Agreement, dated January 20, 2009, between the Company
and Facet Biotech Corporation (incorporated by reference to Exhibit 2.2 to Annual Report on Form 10-K
filed March 2, 2009)
Restated Certificate of Incorporation effective March 23, 1993 (incorporated by reference to Exhibit 3.1 to
Annual Report on Form 10-K filed March 31, 1993)
Certificate of Amendment of Certificate of Incorporation effective August 21, 2001 (incorporated by
reference to Exhibit 3.3 to Annual Report on Form 10-K filed March 14, 2002)
Certificate of Amendment of Certificate of Incorporation effective January 9, 2006 (incorporated by reference
to Exhibit 99.1 to Current Report on Form 8-K filed January 10, 2006)
Certificate of Designation, Preferences and Rights of the Terms effective August 25, 2006 (incorporated by
reference to Exhibit 3.4 to Registration Statement on Form 8-A filed September 6, 2006)
Third Amended and Restated Bylaws effective December 4, 2014 (incorporated by reference to Exhibit 99.1
to Current Report on Form 8-K filed December 9, 2014)
Certificate of Amendment of Restated Certificate of Incorporation effective May 22, 2013 (incorporated by
reference to Exhibit 4.4 to Registration Statement on Form S-3 filed June 21, 2013)
Indenture between the Company and The Bank of New York Mellon Trust Company, N.A., dated February
12, 2014 (incorporated by reference to Exhibit 4.1 to Current Report on Form 8-K filed February 12, 2014)
Supplemental Indenture between the Company and The Bank of New York Mellon Trust Company, N.A.,
dated February 12, 2014 (incorporated by reference to Exhibit 4.1 to Current Report on Form 8-K filed
February 12, 2014)
Second Supplemental Indenture between the Company and The Bank of New York Mellon Trust Company,
N.A., dated February 28, 2014 (incorporated by reference to Exhibit 4.9 to Annual Report on Form 10-K filed
March 3, 2014)
Indenture between the Company and the Bank of New York Mellon Trust Company, N.A., dated November
22, 2016 (incorporated by reference to Exhibit 4.1 to Current Report on Form 8-K filed November 28, 2016)
Supplemental Indenture between the Company and The Bank of New York Mellon Trust Company, N.A.,
dated November 22, 2016 (incorporated by reference to Exhibit 4.2 to Current Report on Form 8-K filed
November 28, 2016)
Indenture, dated September 17, 2019, between the Company, as Issuer and The Bank of New York Mellon
Trust Company, N.A., as Trustee (incorporated by reference to Exhibit 4.1 to Current Report on Form 8-K
filed September 17, 2019)
Supplemental Indenture, dated September 17, 2019 by and between the Company, as Issuer and The Bank of
New York Mellon Trust Company, N.A., as Trustee (incorporated by reference to Exhibit 4.2 to Current
Report on Form 8-K filed September 17, 2019)
Description of Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of
1934
Form of Notice of Grant of Restricted Stock Award under the 2005 Equity Incentive Plan (incorporated by
reference to Exhibit 10.9 to Quarterly Report on Form 10-Q filed August 9, 2006)
Form of Restricted Stock Agreement under the 2005 Equity Incentive Plan (for the officers of the Company)
(incorporated by reference to Exhibit 10.10 to Quarterly Report on Form 10-Q filed August 9, 2006)
Offer Letter between the Company and John McLaughlin, dated November 4, 2008 (incorporated by
reference to Exhibit 10.1 to Current Report on Form 8-K filed November 10, 2008)
146
10.4
10.5
10.6
10.7
10.8
10.9
10.10
Tax Sharing and Indemnification Agreement, dated December 18, 2008, between the Company and Facet
Biotech Corporation (incorporated by reference to Exhibit 10.3 to Current Report on Form 8-K filed
December 23, 2008)
Patent Licensing Master Agreement between the Company and Genentech, Inc., dated September 25, 1998
(incorporated by reference to Exhibit 10.10 to Quarterly Report on Form 10-Q filed November 16, 1998)†
Amendment No. 1 to Patent Licensing Master Agreement between the Company and Genentech, Inc., dated
September 18, 2003 (incorporated by reference to Exhibit 10.45 to Annual Report on Form 10-K filed
March 8, 2004)†
Amendment No. 2 to Patent Licensing Master Agreement between the Company and Genentech, Inc., dated
December 18, 2003 (incorporated by reference to Exhibit 10.26 to Annual Report on Form 10-K filed March
2, 2009)
Amendment No. 1 to the Herceptin License Agreement between the Company and Genentech, Inc., dated
December 18, 2003 (incorporated by reference to Exhibit 10.47 to Annual Report on Form 10-K filed March
8, 2004)
Patent License Agreement, dated July 17, 1997, between the Company and MedImmune Inc. (incorporated
by reference to Exhibit 10.1 to Current Report on Form 8-K filed January 24, 2011)†
Patent License Agreement, dated April 24, 1998, between the Company and Elan International Services Ltd.
(incorporated by reference to Exhibit 10.29 to Annual Report on Form 10-K filed March 2, 2009) †
10.11*
Offer Letter between the Company and Christopher Stone, dated December 30, 2008 (incorporated by
reference to Exhibit 10.29 to Annual Report on Form 10-K filed March 1, 2010)
10.12
10.13
10.14
10.15*
10.16*
10.17
10.18
Settlement Agreement between the Company and Genentech, Inc., dated December 18, 2003 (incorporated
by reference to Exhibit 10.1 to Quarterly Report on Form 10-Q filed November 9, 2010) †
Amended and Restated Patent Licensing Master Agreement between the Company and Genentech, Inc., dated
July 27, 2009 (incorporated by reference to Exhibit 10.2 to Quarterly Report on Form 10-Q filed November
9, 2010)†
Amendments to Product Licenses and Settlement Agreement between the Company and Genentech, Inc.
dated July 27, 2009 (incorporated by reference to Exhibit 10.3 to Quarterly Report on Form 10-Q filed
November 9, 2010)
Offer Letter between the Company and Danny Hart, dated January 11, 2010 (incorporated by reference to
Exhibit 10.1 to Current Report on Form 8-K filed April 18, 2011)
Form of Executive Officer Severance Agreement (incorporated by reference to Exhibit 10.1 to Current Report
on Form 8-K filed May 26, 2011)
Lease Agreement between 932936, LLC and the Company, dated April 17, 2012 (incorporated by reference
to Exhibit 10.1 to Quarterly Report on Form 10-Q filed May 3, 2012)
Credit Agreement between the Company and Wellstat Diagnostics, LLC, dated November 2, 2012
(incorporated by reference to Exhibit 10.50 to Annual Report on Form 10-K filed March 1, 2013)†
10.19*
Offer Letter between the Company and Peter Garcia, dated March 27, 2013 (incorporated by reference to
Exhibit 10.1 to Current Report on Form 8-K filed April 30, 2013)
10.20
10.21
10.22
10.23
10.24
Credit Agreement between the Company and Avinger, Inc., dated April 18, 2013 (incorporated by reference
to Exhibit 10.1 to Quarterly Report on Form 10-Q filed August 8, 2013)†
Amended and Restated Credit Agreement between the Company and Wellstat Diagnostics, LLC, dated
August 15, 2013 (incorporated by reference to Exhibit 10.2 to Quarterly Report on Form 10-Q filed
November 6, 2013)†
Form of Credit Agreement between the Company and certain borrowers (incorporated by reference to Exhibit
10.56 to Annual Report on Form 10-K filed March 3, 2014)
Royalty Purchase and Sale Agreement between the Company and Depomed, Inc. and Depo DR Sub, LLC,
dated October 18, 2013 (incorporated by reference to Exhibit 10.58 to Annual Report on Form 10-K filed
March 3, 2014)†
Settlement Agreement among Genentech, Inc., F. Hoffman-la Roche Ltd. and the Company, dated January
31, 2014 (incorporated by reference to Exhibit 10.2 to Quarterly Report on Form 10-Q filed May 12, 2014)†
147
10.25
10.26
10.27*
10.28
10.29
10.30
10.31
10.32
10.33*
10.34*
10.35
10.36*
10.37*
10.38
10.39*
10.40
10.41
10.42
10.43
10.44
10.45*
Summary of omitted Credit Agreement between PDL BioPharma, Inc. and Paradigm Spine, LLC, dated
February 14, 2014 (incorporated by reference to Exhibit 10.5 to Quarterly Report on Form 10-Q filed May
12, 2014)
Note Purchase Agreement between the Company and Accel 300, LLC, dated April 1, 2014 (incorporated by
reference to Exhibit 10.1 to Quarterly Report on Form 10-Q filed August 18, 2014)
2014/18 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.2 to Quarterly Report on Form
10-Q filed August 18, 2014)
First Amendment to Lease Agreement between 932936, LLC and the Company, effective May 27, 2014
(incorporated by reference to Exhibit 10.3 to Quarterly Report on Form 10-Q filed August 18, 2014)
First Amendment to Amended and Restated Credit Agreement between the Company and Wellstat
Diagnostics, LLC, dated June 19, 2014 (incorporated by reference to Exhibit 10.4 to Quarterly Report on
Form 10-Q filed August 18, 2014)†
Second Amendment to Amended and Restated Credit Agreement between the Company and Wellstat
Diagnostics, LLC, dated August 21, 2014 (incorporated by reference to Exhibit 10.64 to Annual Report on
Form 10-K filed February 23, 2015)†
Third Amendment to Amended and Restated Credit Agreement between the Company and Wellstat
Diagnostics, LLC, dated November 4, 2014 (incorporated by reference to Exhibit 10.65 to Annual Report on
Form 10-K filed February 23, 2015)†
Schedule of Amendment to Omitted Credit Amendment between PDL BioPharma, Inc. and Direct Flow
Medical (incorporated by reference to Exhibit 10.67 to Annual Report on Form 10-K filed February 23, 2015)
2015/19 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.2 to Quarterly Report on Form
10-Q filed May 6, 2015)
Offer Letter between the Company and Steffen Pietzke, executed May 19, 2015 (incorporated by reference to
Exhibit 10.1 to Current Report on Form 8-K filed June 24, 2015)
Second Amendment to Lease Agreement between 932936, LLC and the Company, effective May 19, 2015
(incorporated by reference to Exhibit 10.3 to Quarterly Report on Form 10-Q filed August 5, 2015)
Amended and Restated 2005 Equity Incentive Plan effective May 28, 2015 (incorporated by reference to
Exhibit 10.4 to Quarterly Report on Form 10-Q filed August 5, 2015)
Amended and Restated 2015/19 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.2 to
Quarterly Report on Form 10-Q filed November 4, 2015)
Schedule of Amendments to Omitted Credit Amendments between PDL BioPharma, Inc. and LENSAR, Inc.
and between PDL BioPharma, Inc. and Paradigm Spine, LLC (incorporated by reference to Exhibit 10.71 to
Annual Report on Form 10-K filed February 23, 2016)
2016/20 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.2 to Quarterly Report on Form
10-Q filed May 4, 2016)
Asset Purchase Agreement between Novartis AG, Novartis Pharma AG, Speedel Holding AG and Noden
Pharma DAC, dated as of May 24, 2016 (incorporated by reference to Exhibit 2.1 to Current Report on Form
8-K/A filed August 3, 2016)†
Schedule of Amendment to Omitted Credit Agreement between PDL BioPharma, Inc. and Direct Flow
Medical, Inc. (incorporated by reference to Exhibit 10.2 to Quarterly Report on Form 10-Q filed August 4,
2016)
Supply Agreement between Novartis Pharma AG and Noden Pharma DAC, dated as of May 24, 2016
(incorporated by reference to Exhibit 10.4 to Quarterly Report on Form 10-Q filed August 4, 2016)†
Noden Pharma DAC Investment and Stockholders’ Agreement by and among Noden Pharma DAC, PDL
BioPharma, Inc., Elie Farah and other Persons listed on Annex A thereto, dated as of July 1, 2016
(incorporated by reference to Exhibit 10.5 to Quarterly Report on Form 10-Q filed August 4, 2016)†
Schedule of Amendment to Omitted Credit Amendment between PDL BioPharma, Inc. and LENSAR, Inc.
(incorporated by reference to Exhibit 10.75 to Annual Report on Form 10-K filed March 1, 2017)
2017 Annual Bonus Plan (incorporated by reference to Exhibit 10.1 to Quarterly Report on Form 10-Q filed
May 3, 2017)
148
10.46*
10.47
10.48*
10.49*
10.50*
10.51*
10.52
10.53*
10.54*
10.55*
10.56*
10.57
10.58*
10.59*
10.60
10.61*
10.62*
10.63†
10.64*
10.65
10.66#
2017/21 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.2 to Quarterly Report on Form
10-Q filed May 3, 2017)
Third Amendment to Lease Agreement between 932936, LLC and the Company, effective April 24, 2017
(incorporated by reference to Exhibit 10.3 to Quarterly Report on Form 10-Q filed May 3, 2017)
Offer Letter between the Company and Dominique Monnet, dated August 31, 2017 (incorporated by
reference to Exhibit 10.1 to Current Report on Form 8-K filed September 11, 2017)
Form of Nonstatutory Inducement Stock Option Grant Notice and Nonstatutory Inducement Stock Option
Agreement between PDL BioPharma, Inc. and Dominique Monnet. (incorporated by reference to Exhibit
99.1 to Form S-8 Registration Statement filed September 12, 2017)
Form of Inducement Restricted Stock Grant Notice and Inducement Restricted Stock Agreement between
PDL BioPharma, Inc. and Dominique Monnet (incorporated by reference to Exhibit 99.2 to Form S-8
Registration Statement filed September 12, 2017)
Confidential Separation Agreement and Release of All Claims between Danny Hart and the Company, dated
as of October 23, 2017 (incorporated by reference to Exhibit 10.2 to Quarterly Report on Form 10-Q filed
November 13, 2017)
Fourth Amendment to Lease Agreement between 932936, LLC and the Company, effective December 1,
2017
Amended and Restated 2005 Equity Incentive Plan (incorporated by reference to Exhibit 99.1 to Form S-8
Registration Statement filed June 8, 2018)
Form of Stock Option Grant Notice and Stock Option Agreement for use in connection with awards under the
Amended and Restated 2005 Equity Incentive Plan (incorporated by reference to Exhibit 99.2 to Form S-8
Registration Statement filed June 8, 2018)
Form of Restricted Stock Grant Notice and Restricted Stock Agreement for use in connection with awards
under the Amended and Restated 2005 Equity Incentive Plan (incorporated by reference to Exhibit 99.3 to
Form S-8 Registration Statement filed June 8, 2018)
2018 Annual Bonus Plan (incorporated by reference to Exhibit 10.1 to Quarterly Report on Form 10-Q filed
August 9, 2018)
Amendment No. 1 to Royalty Purchase and Sale Agreement and Bill of Sale between PDL Investment
Holding, LLC and Depomed, Inc. and Depo DR Sub, LLC, dated August 2, 2018 (incorporated by reference
to Exhibit 10.2 to Quarterly Report on Form 10-Q filed August 9, 2018)
Form of Director and Officer Indemnification Agreement (incorporated by reference to Exhibit 10.2 to
Quarterly Report on Form 10-Q filed November 7, 2018)
Executive Severance Plan and Schedule of Benefits (incorporated by reference to Exhibit 10.1 to Current
Report on Form 8-K filed on April 10, 2019)
Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K
filed on April 11, 2019)
2019 Annual Bonus Plan (incorporated by reference to Exhibit 10.3 to Quarterly Report on Form 10-Q filed
May 9, 2019)
Offer Letter between the Company and Edward A. Imbrogno (incorporated by reference to Exhibit 10.1 to
Current Report on Form 8-K filed on June 24, 2019)
Noden Settlement Letter and Supply Agreement Amendment (incorporated by reference to Exhibit 10.4 to
Quarterly Report on Form 10-Q filed August 7, 2019)
Confidential Severance Agreement and Release of All Claims (incorporated by reference to Exhibit 10.1 to
Current Report on Form 8-K filed August 19, 2019)
Form of Exchange Agreement (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K
filed September 13, 2019)
Fifth Amendment to Lease Agreement between Mountain Bluebird Investments, LLC and the Company,
effective November 11, 2019
10.67#*
Severance Plan adopted as of November 15, 2019
149
10.68#*
Form of Restricted Stock Agreement (Amended 11/15/19)
10.69#*
Form of Restricted Stock Agreement Amendment Acknowledgment
10.70#*
Form of Stock Option Agreement (Amended 11/15/19)
10.71#*
Form of Stock Option Agreement Amendment Acknowledgment
10.72#*
Form of Stock Option Grant Notice Supplement
10.73#*
Form of Nonstatutory Inducement Stock Option Agreement (Amended 11/15/19)
10.74#*
Form of Nonstatutory Inducement Stock Option Grant Notice Supplement
10.75#*
Form of Inducement Restricted Stock Agreement (Amended 11/15/19)
10.76#* Wind Down Retention Plan effective as of December 21, 2019
21.1#
23.1#
31.1#
31.2#
Subsidiaries of the Registrant
Consent of Independent Registered Public Accounting Firm
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities
Exchange Act of 1934, as amended
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities
Exchange Act of 1934, as amended
32.1#+
Certifications of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS
XBRL Instance Document
101.SCH
XBRL Taxonomy Extension Schema
101.CAL
XBRL Taxonomy Extension Calculation Linkbase
101.DEF
XBRL Taxonomy Extension Definition Linkbase
101.LAB
XBRL Taxonomy Extension Label Linkbase
101.PRE
XBRL Taxonomy Extension Presentation Linkbase
____________________________________
#
*
†
+
Filed herewith.
Management contract or compensatory plan or arrangement.
Certain information in this exhibit has been omitted and filed separately with the Securities and Exchange Commission
pursuant to a confidential treatment request under 17 C.F.R. Sections 200.80(b)(4) and 24b-2.
The certifications attached as Exhibit 32.1 accompany this Annual Report on Form 10-K pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the
Registrant for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.
150
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
PDL BIOPHARMA, INC.
By:
/S/ DOMINIQUE MONNET
(Dominique Monnet)
President and Chief Executive Officer
Date: March 11, 2020
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
Title
President and Chief Executive Officer
(Principal Executive Officer)
Date
March 11, 2020
/S/ DOMINIQUE MONNET
(Dominique Monnet)
/S/ EDWARD A. IMBROGNO
(Edward A. Imbrogno)
ALAN BAZAAR
(Alan Bazaar)
/S/ DAVID GRYSKA
(David Gryska)
/S/ NATASHA A. HERNDAY
(Natasha A. Hernday)
/S/ JOHN P. MCLAUGHLIN
(John P. McLaughlin)
/S/ ELIZABETH O’FARRELL
(Elizabeth O’Farrell)
/S/ PAUL W. SANDMAN
(Paul W. Sandman)
/S/ SHLOMO YANAI
(Shlomo Yanai)
Vice President and Chief Financial Officer (Principal Financial
Officer and Principal Accounting Officer)
March 11, 2020
March 11, 2020
March 11, 2020
March 11, 2020
March 11, 2020
March 11, 2020
March 11, 2020
March 11, 2020
Director
Director
Director
Director
Director
Director
Director
151
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): June 29, 2020
PDL BioPharma, Inc.
(Exact name of Company as specified in its charter)
000-19756
(Commission File Number)
Delaware
(State or Other Jurisdiction of
Incorporation)
94-3023969
(I.R.S. Employer Identification No.)
932 Southwood Boulevard
Incline Village, Nevada 89451
(Address of principal executive offices, with zip code)
(775) 832-8500
(Company’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the
Company under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common stock, par value $0.01 per share
Trading Symbol(s)
PDLI
Name of each exchange on which registered
The NASDAQ Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of
1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange
Act.
[This page intentionally left blank]
Item 8.01 Other Events.
In this report all references to “PDL,” “we,” “us,” “our” or the “Company” mean collectively PDL BioPharma, Inc. and its
subsidiaries, except where it is made clear that the term means only PDL BioPharma, Inc.
As described in our Annual Report on Form 10-K for the year ended December 31, 2019 which was filed with the Securities
and Exchange Commission ("SEC") on March 11, 2020, and as amended on Form 10-K/A and filed with the SEC on April 29,
2020, (collectively, the “2019 Form 10-K”) and further discussed in our Quarterly Report on Form 10-Q for the quarter ended
March 31, 2020 (the “2020 First Quarter Form 10-Q”) filed with the SEC on May 11, 2020, in September 2019, we engaged
financial and legal advisors and initiated a review of our strategy. This review was completed in December 2019. At such time,
we disclosed that we planned to halt the execution of our growth strategy, cease making additional strategic transactions and
investments and instead pursue a formal process to unlock the value of our portfolio by monetizing our assets and ultimately
distributing net proceeds to stockholders (the “monetization strategy”). Pursuant to our monetization strategy, we do not expect
to enter into any additional strategic transactions or investments. We further announced in December 2019 that we would
explore a variety of potential transactions in connection with the monetization strategy, including a whole Company sale,
divestiture of assets, spin-offs of operating entities, merger opportunities or a combination thereof.
Over the subsequent months, our Board of Directors (the “Board”) and management analyzed, together with outside financial
and legal advisors, how to best capture value pursuant to our monetization strategy and best return the significant intrinsic
value of the high-quality assets in our portfolio to our stockholders. During the first quarter of 2020, the Board approved a plan
of complete liquidation (the “Plan of Liquidation”) and passed a resolution to seek stockholder approval at the next Annual
Meeting of Stockholders to dissolve the Company under Delaware law in the event that the Board concludes that the whole
Company sale process is unlikely to maximize the value that can be returned to the stockholders from our monetization
process. We would, if approved by the stockholders, file a Certificate of Dissolution in Delaware and proceed to wind-down
and dissolve the Company in accordance with Delaware law.
In addition, we have analyzed, and continue to analyze, the optimal mechanisms for returning value to stockholders in a tax-
efficient manner, including via share repurchases, cash dividends and other distributions of assets. We have not set a definitive
timeline and intend to pursue monetization in a disciplined and cost-effective manner seeking to maximize returns to
stockholders. We recognize, however, that accelerating the timeline, while continuing to seek to optimize asset value, could
increase returns to stockholders due to reduced general and administrative expenses as well as potentially provide faster returns
to stockholders. While, as noted above, we cannot provide a definitive timeline for the monetization and wind-down process,
we are targeting the end of 2020 for completing the monetization of our key assets.
As we began a comprehensive program to market and sell our key assets, this had a significant effect on the reported financial
results of the Company. As of March 31, 2020, the Pharmaceutical segment and the royalty right assets within the Income
Generating Assets segment met the criteria to be classified as held for sale. Those investments were reported as discontinued
operations on the Condensed Consolidated Statements of Operations for the three months ended March 31, 2020 and 2019 and
as Assets and Liabilities held for sale on the Condensed Consolidated Balance Sheets as of March 31, 2020 and December 31,
2019.
The Company is filing this Current Report on Form 8-K (the “Form 8-K”) to revise and recast certain historical financial
information originally included in our 2019 Form 10-K, and to revise the description of the Company’s business contained in
Part I, Item 1 of the 2019 Form 10-K. The information included in Exhibit 99.1 to this Form 8-K presents the financial results
of the Pharmaceutical segment and royalty right assets as discontinued operations for all periods presented. These updates are
consistent with the presentation of discontinued operations included in the 2020 First Quarter Form 10-Q and with rules of the
SEC requiring the reissuance of prior period financial statements included or incorporated by reference in a registration
statement or proxy statement to retrospectively revise and reclassify such pre-event financial statements to reflect accounting
changes, such as discontinued operations. The information included in Exhibit 99.1 to this Form 8-K has been updated to
present information relating only to the continuing operations of the Company.
We have revised the following portions of the 2019 Form 10-K to reflect the retrospective revisions described above:
Part I
Part II
· Item 1. Business.
· Item 6. Selected Consolidated Financial Data;
· Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations; and
· Item 8. Financial Statements and Supplementary Data.
The information included in Exhibit 99.1 to this Form 8-K is presented in connection with the reporting changes described
above and does not otherwise amend or restate the 2019 Form 10-K. Unaffected items and unaffected portions of the 2019
Form 10-K have not been repeated in, and are not amended or modified by, Exhibit 99.1 to this Form 8-K. Exhibit 99.1 to this
Form 8-K do not reflect events occurring after we filed the 2019 Form 10-K, and do not modify or update the disclosures
therein in any way, other than the aforementioned retrospective revisions, as well as certain other events disclosed in Events
Subsequent to Original Issuance of Financial Statements within Item 7 of Exhibit 99.1 and Note 27 - Subsequent Events within
Item 8 of Exhibit 99.1. We have not otherwise updated for activities or events occurring after the date these items were
originally presented. This Form 8-K and Exhibit 99.1 should be read in conjunction with our other filings made with the SEC,
including, and subsequent to, the date of the 2019 Form 10-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No.
23.1
99.1
101.INS
101.SCH
101.CAL
101.LAB
101.PRE
101.DEF
Consent of PricewaterhouseCoopers LLP
Updated Part I Item 1. Business, Part II Item 6. Selected Consolidated Financial Data, Item 7. Management's
Discussion and Analysis of Financial Condition and Results of Operations, Part II Item 8. Financial Statements
and Supplementary Data
Description
XBRL Instance Document
XBRL Taxonomy Extension Schema Document
XBRL Taxonomy Extension Calculation Linkbase Document
XBRL Taxonomy Extension Label Linkbase Document
XBRL Taxonomy Extension Presentation Linkbase Document
XBRL Taxonomy Extension Definition Linkbase Document
Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on
its behalf by the undersigned hereunto duly authorized.
SIGNATURES
PDL BIOPHARMA, INC.
(Company)
By:
/s/ Dominique Monnet
Dominique Monnet
President and Chief Executive Officer
Dated: June 29, 2020
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form S-3 (No. 333-36708, 333-122760,
333-123958, 333-128644, 333-211970 and 333-231870) and on Form S-8 (No. 333-87957, 333-68314, 333-104170,
333-125906, 333-145262, 333-220370, 333-220435 and 333-225534) of PDL BioPharma, Inc. of our report dated March 11,
2020, except with respect to our opinion on the consolidated financial statements insofar as it relates to the effects of
discontinued operations discussed in Note 3, as to which the date is June 29, 2020, relating to the financial statements and the
effectiveness of internal control over financial reporting, which appears in this Current Report on Form 8-K.
Exhibit 23.1
/s/ PricewaterhouseCoopers LLP
San Francisco, California
June 29, 2020
EXPLANATORY STATEMENT
Exhibit 99.1
In this report all references to “PDL,” “we,” “us,” “our” or the “Company” mean collectively PDL BioPharma, Inc. and its
subsidiaries, except where it is made clear that the term means only PDL BioPharma, Inc.
As previously reported in our filings with the Securities and Exchange Commission (the “SEC”), we have undertaken a review of
our strategy and have announced plans to halt the execution of our growth strategy, cease making additional strategic investments
and instead pursue a formal process to unlock the value of our portfolio by monetizing our assets and ultimately distributing net
proceeds to stockholders (the “monetization strategy”). Pursuant to our monetization strategy, we do not expect to make any
additional strategic investments. We further announced in December 2019 that we would explore a variety of potential
transactions in connection with the monetization strategy, including a whole Company sale, divestiture of assets, spin-offs of
operating entities, merger opportunities or a combination thereof. Over the subsequent months, our Board of Directors (the
“Board”) and management analyzed, together with outside financial and legal advisors, how to best capture value pursuant to our
monetization strategy and best return the significant intrinsic value of the high-quality assets in our portfolio to our stockholders.
During the first quarter of 2020, the Board approved a plan of complete liquidation (the “Plan of Liquidation”) and passed a
resolution to seek stockholder approval at the next Annual Meeting of Stockholders to dissolve the Company as permitted by the
General Corporation Law of the State of Delaware (the “DGCL”). In the event that the proposal is approved by stockholders and
the Board concludes that the whole Company sale process is unlikely to maximize the value that can be returned to the
stockholders from our monetization process, we intend to file a Certificate of Dissolution with the Secretary of State of Delaware
after monetizing our key assets and then proceed to wind-down and dissolve the Company in accordance with the DGCL.
As we began a comprehensive program to market and sell our significant assets, this had a significant effect on the reported
financial results of the Company. As of March 31, 2020, the Pharmaceutical segment and the royalty right assets within the
Income Generating Assets segment met the criteria to be classified as held for sale. Those investments were reported as
discontinued operations on the Condensed Consolidated Statements of Operations for the three months ended March 31, 2020 and
2019 and as Assets and Liabilities held for sale on the Condensed Consolidated Balance Sheets as of March 31, 2020 and
December 31, 2019. These assets and associated liabilities are also classified as held for sale and discontinued operation in our
Current Report on Form 8-K filed with the SEC on June 29, 2020 (including this Exhibit 99.1 thereto, the “Form 8-K”), in which
we recast the financial information contained in our Annual Report on Form 10-K for the year ended December 31, 2019 (the
“2019 Form 10-K”) to present the operations and financial position of these entities as discontinued operations.
Unless otherwise indicated, the information in this Form 8-K, including our segment information, relates only to our continuing
operations. We also announced that we are considering various strategic options with respect to the rest of our business. Because
our remaining operating business and other investments do not meet the criteria to be classified as held for sale or a discontinued
operation, they continue to be included in our continuing operations.
The information included in Exhibit 99.1 to this Form 8-K is presented in connection with the reporting changes described above
and does not otherwise amend or restate the 2019 Form 10-K. Unaffected items and unaffected portions of the 2019 Form 10-K
have not been repeated in, and are not amended or modified by, Exhibit 99.1 to this Form 8-K. Exhibit 99.1 to this Form 8-K do
not reflect events occurring after we filed the 2019 Form 10-K, and do not modify or update the disclosures therein in any way,
other than the aforementioned retrospective revisions, as well as certain other events disclosed in Note 27 - Subsequent Events
within Item 8 of Exhibit 99.1. We have not otherwise updated for activities or events occurring after the date these items were
originally presented. This Form 8-K and Exhibit 99.1 should be read in conjunction with our other filings made with the SEC,
including, and subsequent to, the date of the 2019 Form 10-K.
Forward-looking Statements
PART I
This Form 8-K contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than
statements of historical facts are “forward-looking statements” for purposes of these provisions, including any projections of
earnings, revenues or other financial items, any statements of the plans and objectives of management for future operations,
including any statements concerning the timing, implementation or success of our monetization strategy/plan of complete
liquidation, any statements regarding future economic conditions or performance, and any statement of assumptions underlying
any of the foregoing. These statements involve known and unknown risks, uncertainties and other important factors that may
cause our actual results, performance or achievements to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking statements. In some cases, forward-looking statements can be
identified by the use of terminology such as “may,” “will,” “intends,” “plans,” “believes,” “targets,” “anticipates,” “expects,”
“estimates,” “predicts,” “potential,” “continue” or “opportunity,” or the negative thereof or other comparable terminology. The
forward-looking statements in this Form 8-K are only predictions. Although we believe that the expectations presented in the
forward-looking statements contained herein are reasonable at the time of filing, there can be no assurance that such expectations
or any of the forward-looking statements will prove to be correct. These forward-looking statements, including with regards to our
future financial condition and results of operations, are subject to inherent risks and uncertainties, including but not limited to the
risk factors set forth below, and for the reasons described elsewhere in this Form 8-K. All forward-looking statements and reasons
why results may differ included in this Form 8-K are made as of the date hereof. New risk factors and uncertainties may emerge
from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by
applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result
of any new information, future events, changed circumstances or otherwise. Important factors that could cause actual results to
differ materially from our expectations, including, without limitation, in conjunction with the forward-looking statements included
in this Form 8-K, are disclosed in “Item 1-Business, Item 1A-Risk Factors” of our December 31, 2019 Form 10-K, as updated in
Part II, Item 1A of our Form 10-Q for the quarter ended March 31, 2020.
We own or have rights to certain trademarks, trade names, copyrights and other intellectual property used in our business,
including PDL BioPharma, Inc. and the PDL logo, each of which is considered a registered trademark. All other company names,
product names, trade names and trademarks included in this Form 8-K are trademarks, registered trademarks or trade names of
their respective owners.
2
ITEM 1. BUSINESS
Overview
In this report all references to “PDL,” “we,” “us,” “our” or the “Company” mean collectively PDL BioPharma, Inc. and its
subsidiaries, except where it is made clear that the term means only PDL BioPharma, Inc.
Throughout our history, our mission has been to improve the lives of patients by aiding in the successful development of
innovative therapeutics and healthcare technologies. PDL BioPharma was founded in 1986 as Protein Design Labs, Inc. when it
pioneered the humanization of monoclonal antibodies, enabling the discovery of a new generation of targeted treatments that have
had a profound impact on patients living with different cancers as well as a variety of other debilitating diseases. In 2006, we
changed our name to PDL BioPharma, Inc.
As previously announced and as discussed above, in September 2019, we engaged financial and legal advisors and initiated a
review of our strategy. In December 2019, we disclosed that we planned to halt the execution of our growth strategy, cease
making additional strategic transactions and investments and instead pursue a formal process to unlock the value of our portfolio
by monetizing our assets and ultimately distributing net proceeds to stockholders. Over the subsequent months, our Board and
management analyzed, together with outside financial and legal advisors, how to best capture value pursuant to our monetization
strategy and best return the significant intrinsic value of the high-quality assets in our portfolio to our stockholders. In February
2020, the Board approved a plan of complete liquidation of our assets and passed a resolution to seek stockholder approval to
dissolve the Company pursuant to a plan of complete liquidation under Delaware law at our next annual meeting of the
stockholders. In the event that the Board concludes that the whole Company sale process is unlikely to maximize the value that
can be returned to the stockholders from our monetization process, the Company would, if approved by the stockholders, file a
Certificate of Dissolution in Delaware and proceed to wind-down and dissolve the company in accordance with Delaware law.
Pursuant to our monetization strategy, we are exploring a variety of potential transactions, including a whole Company sale,
divestiture of assets, spin-offs of operating entities, merger opportunities or a combination thereof. In addition, we have analyzed,
and continue to analyze, the optimal mechanisms for returning value to stockholders in a tax-efficient manner, including via share
repurchases, cash dividends and other distributions of assets. We have not set a definitive timeline and intend to pursue
monetization in a disciplined and cost-effective manner seeking to maximize returns to stockholders. We recognize, however, that
accelerating the timeline, while continuing to seek to optimize asset value, could increase returns to stockholders due to reduced
general and administrative expenses as well as potentially provide faster returns to stockholders. While, as noted above, we
cannot provide a definitive timeline for the monetization and wind-down process, we are targeting the end of 2020 for completing
the monetization of our key assets, at which time we may be in a position to file a certificate of dissolution under Delaware law.
Our Segments
Historically, we generated a substantial portion of our revenues through the license agreements related to patents covering the
humanization of antibodies, which we refer to as the Queen et al. patents. In 2012, and in anticipation of declining revenues from
the Queen et al. patents, we began providing alternative sources of capital through royalty monetizations and debt facilities, and,
in 2016, we began acquiring commercial-stage products and launching specialized companies dedicated to the commercialization
of these products, first with our acquisition of branded prescription pharmaceutical drugs from Novartis AG, Novartis Pharma AG
and Speedel Holding AG (collectively, “Novartis”) in 2016 and, in 2017, with the acquisition of LENSAR, Inc. (“LENSAR”), a
medical device ophthalmology equipment manufacturing company.
Based on the nature of our investments entered into between 2012 through 2016 and further discussed below, our operations were
structured in three segments designated as Income Generating Assets, Pharmaceutical and Medical Devices.
In early 2019, and as a further evolution of our strategy, we began to enter into strategic transactions involving innovative late
clinical-stage or early commercial-stage therapeutics with attractive revenue growth potential with the intention to provide a
significant return for our stockholders. In 2019, consistent with this strategy, we entered into a securities purchase agreement with
Evofem Biosciences, Inc. (“Evofem”), pursuant to which we invested $60.0 million in a private placement of securities. As a
result of this investment in Evofem we established a fourth segment, “Strategic Positions.” The creation of the Strategic Positions’
segment had no impact on our prior segment reporting structure.
Our Medical Devices segment consists of revenue from the sale and lease of the LENSAR® Laser System, which may include
equipment, Patient Interface Devices (“PIDs”), procedure licenses, training, installation, warranty and maintenance agreements.
3
Our Strategic Positions segment consists of an investment in Evofem (NASDAQ: EVFM). Our investment includes shares of
common stock and warrants to purchase additional shares of common stock. Evofem is a pre-commercial company and, as such,
is not yet engaged in revenue-generating activities.
Our Pharmaceutical segment consists of revenue derived from branded prescription medicine products sold under the name
Tekturna® and Tekturna HCT® in the United States, Rasilez® and Rasilez HCT® in the rest of the world and revenue generated
from the sale of an authorized generic form of Tekturna in the United States (collectively, the “Noden Products”).
Our Income Generating Assets segment consists of revenue derived from (i) notes and other long-term receivables, (ii) royalty
rights and hybrid notes/royalty receivables, (iii) equity investments and (iv) royalties from issued patents in the United States and
elsewhere covering the humanization of antibodies, which we refer to as the Queen et al. patents.
Pursuant to the above-described strategic decisions, in 2020 we began a comprehensive program to market and sell our key assets
and this had a significant effect on the reported financial results of the Company. As of March 31, 2020, the Pharmaceutical
segment and the royalty right assets within the Income Generating Assets segment met the criteria to be classified as held for sale.
Because our Medical Devices, Strategic Positions and non-royalty rights assets within our Income Generating Assets segment did
not meet the criteria to be classified as held for sale or discontinued operations, the results for these segments and assets are
reported within continuing operations for all periods presented. Our Pharmaceutical segment and the royalty right assets within
the Income Generating Assets segment have been excluded from the segment information below as a result of meeting the held
for sale and discontinued operations criteria.
Financial information about our segments, including our revenues and net (loss) income for the years ended December 31, 2019,
2018 and 2017, and select long-lived assets as of December 31, 2019 and 2018, is included in our Consolidated Financial
Statements and accompanying notes in this Form 8-K.
Medical Devices
LENSAR
LENSAR is a medical device company focused on delivering next generation femtosecond cataract laser technology used in
refractive cataract surgical procedures. LENSAR’s femtosecond laser uses advanced imaging and laser technology to customize
planning and treatments, allowing faster visual recovery and improved outcomes, as compared to conventional cataract surgery, a
more manual procedure combined with ultrasound, referred to as phacoemulsification. LENSAR has developed the LENSAR®
Laser System, which is the only femtosecond cataract laser built specifically for refractive cataract surgery.
Cataract surgery is the highest volume surgical procedure performed worldwide with 30 million surgeries projected in 2020, the
majority of which use conventional phacoemulsification techniques. LENSAR is currently focusing its research and development
efforts on an advanced integrated workstation combining an enhanced LENSAR® Laser System and a phacoemulsification device
in a single, compact workstation, designed to fit directly in the surgical theater. LENSAR’s recent acquisitions of certain
intellectual property uniquely position LENSAR to develop a system that can perform all cataract surgeries in a single platform.
The LENSAR® Laser System offers cataract surgeons automation and customization for their astigmatism treatment planning and
other essential steps of the refractive cataract surgery procedure with the highest levels of precision, accuracy, and efficiency.
These features assist surgeons in managing their astigmatism treatment plans for optimal overall visual outcomes.
The LENSAR® Laser System has been cleared by the U.S. Food and Drug Administration (“FDA”) for anterior capsulotomy, lens
fragmentation, corneal and arcuate incisions. The LENSAR Laser with Augmented Reality™ provides an accurate 3-D model of
the relevant anatomical features of each patient’s anterior segment, allowing precise laser delivery and enhanced surgical
confidence in performing accurate corneal incisions, precise size, shape and location of free-floating capsulotomies, and efficient
lens fragmentation for all grades of cataracts. The LENSAR® Laser System - fs 3D (LLS-fs 3D) with Streamline™ includes the
integration with multiple pre-operative diagnostic devices, utilizing automated Iris Registration with automatic cyclorotation
adjustment. IntelliAxis-C™ (corneal) and IntelliAxis-L™ (lens capsule) markers provide the surgeon tools for simple and precise
alignment without errors associated with manually transposing the preoperative data, and marking the eye for incisions and
implantation of Toric IOLs as well as treatment planning tools for precision guided laser treatments. The corneal incision-only
mode, expanded remote diagnostics capabilities, additional pre-programmable preferences, thoughtful ergonomics, and up to 20
seconds faster laser treatment times with Streamline allow for seamless integration and maximum surgical efficiency with patient
comfort.
4
Intellectual Property
LENSAR has over 85 granted patents in the United States and rest of the world and over 60 pending patent applications in the
United States and rest of the world. LENSAR acquired a number of patents in 2019 to support the development and eventual
commercialization of its second generation laser system which will combine a femtosecond cataract laser system with a
phacoemulsification system in a single machine.
Manufacturing
Through our LENSAR subsidiary, we currently manufacture our LENSAR® Laser System at a facility in Orlando, Florida.
LENSAR purchases both custom and off-the-shelf components from a small number of suppliers and subjects them to stringent
quality specifications and processes. Some of the components necessary for the assembly of the LENSAR® Laser System are
currently provided by sole-sourced suppliers (the only recognized supply source available to us) or single-sourced suppliers (the
only approved supply source for us among other sources). LENSAR purchases the majority of its components and major
assemblies through purchase orders with limited long-term supply agreements and generally does not maintain large volumes of
finished goods.
LENSAR has entered into various supply agreements for the manufacture and supply of certain components. The supply
agreements commit LENSAR to a minimum purchase obligation of approximately $10.4 million over the next twenty-four
months of which $9.6 million is due in the next 12 months. LENSAR expects to meet these requirements.
Sales and Distribution
LENSAR markets and sells the LENSAR® Laser System to ophthalmic ambulatory surgical centers, specialty ophthalmic
hospitals and multi-specialty hospitals in the United States through a direct sales force. Outside of the United States, LENSAR
typically sells the LENSAR® Laser System through distributors. A distributor in Asia and a distributor in Europe represent 25%
and 11%, respectively, of the net sales in our Medical Devices segment for the year ended December 31, 2019.
Competition
The LENSAR® Laser System is a femtosecond cataract laser for refractive cataract surgery. We estimate that the market
penetration of femtosecond cataract laser surgery is approximately 10.7% of total procedures in the United States and
approximately 2.8% of the total cataract surgeries performed globally. Femtosecond cataract laser procedures are forecast to grow
approximately 5.0% annually through 2024.
Employees
As of December 31, 2019, we had 75 full-time employees at LENSAR, who manage its business and operations.
Strategic Positions
Evofem
We invested $60.0 million in Evofem in the second quarter of 2019, representing approximately a 28% ownership interest in the
company as of December 31, 2019. The transaction was structured in two tranches. The first tranche comprised $30.0 million,
which was funded on April 11, 2019. We invested an additional $30.0 million in a second tranche on June 10, 2019, alongside two
existing Evofem shareholders, who each invested an additional $10.0 million. These investments were expected to provide
funding for Evofem's pre-commercial activities for Amphora®, its investigational, non-hormonal, on-demand prescription
contraceptive gel for women. We believe this investment provided us the ability to take a significant position in a promising
company at a critical stage of development where we could provide meaningful contributions through our capital and expertise.
Evofem is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to
address unmet needs in women's sexual and reproductive health. Evofem is leveraging its proprietary Multipurpose Vaginal pH
Regulator (MVP-R™) platform to develop Amphora (L-lactic acid, citric acid and potassium bitartrate) for hormone-free birth
control. In 2015, Evofem submitted a new New Drug Application (“NDA”) for prevention of pregnancy to the FDA. In April
2016, the FDA issued a Complete Response Letter (“CRL”) with respect to the Amphora NDA, citing certain clinical deficiencies.
5
In the fourth quarter of 2019, Evofem resubmitted the Amphora NDA, which included results from a subsequent Phase 3 trial. In
December 2019, the FDA acknowledged receipt of the NDA and assigned a six-month review period and a Prescription Drug
User Fee Act (“PDUFA”) goal date of May 25, 2020.
Amphora is also being studied for the prevention of chlamydia and gonorrhea. In December 2019, Evofem announced positive
top-line results from AMPREVENCE, a Phase 2b clinical trial evaluating the efficacy and safety of Amphora for the prevention of
urogenital chlamydia and gonorrhea in women. Further analysis is ongoing and final results are subject to change based on a
comprehensive review by the company and the FDA.
Income Generating Assets
We have pursued income generating assets when such assets can be acquired on terms that we believe allow us to increase return
to our stockholders. The income generating assets included in continuing operations consist of (i) notes and other long-term
receivables, (ii) equity investments and (iii) royalties from the Queen et. al patents. While we currently maintain a portfolio of
income generating assets, our intention is to no longer pursue these transactions while we focus on our monetization strategy.
Investment
Investment Type
Segment
CareView Communications, Inc. (“CareView”)............
Wellstat Diagnostics, LLC (“Wellstat Diagnostics”) 1...
Debt
Income Generating Assets
Royalty/debt hybrid
Income Generating Assets
_______________
Deployed
Capital 2
(in millions)
$
$
20.0
44.0
1. Also known as Defined Diagnostic, LLC. The Wellstat Diagnostics investment also includes our note receivable
with Hyperion Catalysis International, Inc. (“Hyperion”).
2. Excludes transaction costs.
Notes and Other Long-Term Receivables
We have entered into credit agreements with borrowers across the healthcare industry, under which we made available cash loans
to be used by the borrower. Obligations under these credit agreements are typically secured by a pledge of substantially all the
assets of the borrower and any of its subsidiaries. As of December 31, 2019, we had two notes receivable transactions
outstanding, CareView and Wellstat Diagnostics, which are summarized below:
CareView
Technology
CareView is a provider of products and on-demand application services for the healthcare industry by specializing in
bedside video monitoring, archiving and patient care documentation systems and patient entertainment services.
Deal Summary
In June 2015, we entered into a credit agreement with CareView, whereby we made available to CareView up to $40.0
million in loans comprised of two tranches of $20.0 million each, subject to CareView’s attainment of specified
milestones and under which we have a security interest in substantially all of CareView’s assets. In October 2015, we
and CareView entered into an amendment of the credit agreement to modify certain definitions related to the first and
second tranche milestones and we funded the first tranche of $20.0 million, net of fees, based on CareView’s attainment
of the first milestone, as amended. The second $20.0 million tranche was not funded due to CareView’s failure to meet
the funding milestone and we have no further funding obligation at this time. The outstanding borrowing under the credit
agreement initially bore interest at the rate of 13.5% per annum payable quarterly in arrears. Principal repayment was to
commence on the ninth quarterly interest payment date and continue in equal installments until final maturity of the loan
in October 2020.
In February 2018, we entered into a modification agreement with CareView (the “February 2018 Modification
Agreement”) whereby we agreed, effective as of December 28, 2017, to modify the credit agreement before remedies
could otherwise have become available to us under the credit agreement in relation to certain obligations of CareView
6
that would potentially not be met, including the requirement to make principal payments. Under the February 2018
Modification Agreement, we agreed that (i) a lower liquidity covenant would be applicable and (ii) principal repayment
would be delayed for a period of up to December 31, 2018. In exchange for agreeing to these modifications, among other
things, the exercise price of our warrants to purchase 4.4 million shares of common stock of CareView was reduced and,
subject to the occurrence of certain events, CareView agreed to grant us additional equity interests. In each of September
2018, December 2018, May 2019, September 2019 and December 2019, we entered into amendments to the February
2018 Modification Agreement with CareView whereby we agreed to deferrals of principal repayments and interest
payments. In the May 2019 amendment we also increased the interest rate to 15.5% and removed the liquidity covenant
under the credit agreement. In January 2020 we agreed to a further amendment of the February 2018 Modification
Agreement that deferred principal repayment and interest payments until April 30, 2020, which was conditioned upon
CareView raising additional financing from third parties.
Wellstat Diagnostics
Technology
Wellstat Diagnostics is a private company formerly dedicated to the development, manufacture, sale and distribution of
small point of care diagnostic systems.
Deal Summary
In March 2012, we executed a $7.5 million two-year senior secured note receivable with the holders of the equity
interests in Wellstat Diagnostics. In August 2012, we and Wellstat Diagnostics amended the note receivable, providing a
senior secured note receivable of $10.0 million, bearing interest at 12% per annum, to replace the original $7.5 million
note receivable. This $10.0 million note receivable was repaid on November 2, 2012, using the proceeds of the $40.0
million credit facility we entered into on the same date.
In November 2012, we entered into a $40.0 million credit agreement with Wellstat Diagnostics pursuant to which we
were to accrue quarterly interest payments at the rate of 5% per annum. In January 2013, Wellstat Diagnostics defaulted
on the credit agreement, and as a result both parties agreed to enter into a forbearance agreement whereby we agreed to
provide additional funding. In August 2013, we entered into an amended and restated credit agreement with terms
substantially the same as those of the original credit agreement. However, pursuant to the amended and restated credit
agreement the principal amount was reset to approximately $44.1 million.
We, Wellstat Diagnostics, and Samuel J. Wohlstadter, Nadine H. Wohlstadter, Duck Farm, Inc., Hebron Valley Farms,
Inc., HVF, Inc., Hyperion Catalysis EU Limited, Hyperion, NHW, LLC, Wellstat AVT Investment, LLC, Wellstat
Biocatalysis, LLC, Wellstat Biologics Corporation, Wellstat Diagnostics, Wellstat Immunotherapeutics, LLC, Wellstat
Management Company, LLC, Wellstat Ophthalmics Corporation, Wellstat Therapeutics Corporation, Wellstat
Therapeutics EU Limited, Wellstat Vaccines, LLC and SJW Properties, Inc., the guarantors of Wellstat Diagnostics’
obligations to us (collectively, the “Wellstat Diagnostics Guarantors”) were involved in a series of legal actions. A further
discussion of the Wellstat litigation is included in Note 26, Legal Proceedings, to the Consolidated Financial Statements
included in Item 8.
The Wellstat Diagnostics investment also includes our note receivable with Hyperion. A further discussion is included in
Note 8, Notes and Other Long-term Receivables.
Royalties from Queen et al. patents
We have been issued patents in the United States and elsewhere, covering the humanization of antibodies, which we refer to as
our Queen et al. patents. Our Queen et al. patents, for which final patent expiry was in December 2014, covered, among other
things, humanized antibodies, methods for humanizing antibodies, polynucleotide encoding in humanized antibodies and methods
of producing humanized antibodies.
We previously entered into licensing agreements under our Queen et al. patents with numerous entities that are independently
developing or have developed humanized antibodies. Under our licensing agreements, we are entitled to receive a flat-rate royalty
based upon our licensees’ net sales of covered antibodies, although the royalties under these agreements have substantially ended.
7
Solanezumab is a Lilly-licensed humanized monoclonal antibody being tested in a study of older individuals who may be at risk
of memory loss and cognitive decline due to Alzheimer’s disease. Lilly has characterized the study as an assessment of whether
an anti-amyloid investigational drug in older individuals who do not yet show symptoms of Alzheimer's disease cognitive
impairment or dementia can slow memory loss and cognitive decline. The study will also test whether solanezumab treatment can
delay the progression of Alzheimer’s disease related brain injury on imaging and other biomarkers. If solanezumab is approved
and commercialized pursuant to this clinical trial or another, we would be entitled to receive a royalty based on a "know-how"
license for technology provided in the design of this antibody. The 2% royalty on net sales is payable for 12.5 years after the
product's first commercial sale. The above described study is currently in Phase 3 testing with results expected in July of 2022.
For the years ended December 31, 2019, 2018 and 2017, royalties from Queen et al. patents accounted for less than 1%, 2%, and
11% of our total revenues, respectively.
Competition
The underlying products associated with our income generating assets compete with existing products and are vulnerable to new
branded or generic entrants in the marketplace.
Governmental Regulation
The research and development, manufacturing and marketing of pharmaceutical and medical device products are subject to
regulation by numerous governmental authorities in the United States and other countries. We and our borrowers and royalty-
agreement counterparties, depending on specific activities performed, are subject to these regulations. In the United States,
pharmaceuticals and medical devices are subject to regulation by both federal and various state authorities, including the FDA.
The Federal Food, Drug and Cosmetic Act (“FFDCA”) governs the testing, manufacture, safety, efficacy, labeling, storage, record
keeping, approval, advertising and promotion of pharmaceutical and medical device products, and with respect to biologics,
compliance with the Public Health Service Act is also required. There are also comparable laws and regulations that apply at the
state level and in other countries as well. For both currently marketed and products in development, failure to comply with
applicable regulatory requirements can, among other things, result in delays, the suspension of regulatory approvals, as well as
possible civil and criminal sanctions.
The process required by the FDA before a drug may be marketed in the United States generally involves the following:
•
•
•
•
•
•
•
completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good
laboratory practice, or GLP, regulations;
submission to the FDA of an investigational new drug application, or IND, which must become effective before human
clinical trials may begin;
approval by an independent institutional review board, or IRB, at each clinical site before each trial may be initiated;
performance of adequate and well-controlled human clinical trials in accordance with good clinical practice, or GCP,
requirements to establish the safety and efficacy of the proposed drug product for each indication;
submission to the FDA of a new drug application, or NDA;
satisfactory completion of an FDA advisory committee review, if applicable;
satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced
to assess compliance with current good manufacturing practice (“cGMP”), requirements and to assure that the facilities,
methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; and
•
FDA review and approval of the NDA.
Preclinical Studies
Preclinical studies include laboratory evaluation of product chemistry, toxicity and formulation, as well as animal studies to assess
potential safety and efficacy. An IND sponsor must submit the results of the preclinical tests, together with manufacturing
information, analytical data and any available clinical data or literature, among other things, to the FDA as part of an IND. Some
preclinical testing may continue even after the IND is submitted. An IND automatically becomes effective 30 days after receipt by
the FDA, unless before that time the FDA raises concerns or questions related to one or more proposed clinical trials and places
the clinical trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the
clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.
Clinical Trials
8
Clinical trials involve the administration of the investigational new drug to human subjects under the supervision of qualified
investigators in accordance with GCP requirements, which include the requirement that all research subjects provide their
informed consent in writing for their participation in any clinical trial. Clinical trials are conducted under protocols detailing,
among other things, the objectives of the trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be
evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the
IND. In addition, an IRB at each institution participating in the clinical trial must review and approve the plan for any clinical trial
before it commences at that institution. Information about certain clinical trials must be submitted within specific timeframes to
the National Institutes of Health, or NIH, for public dissemination on their www.clinicaltrials.gov website.
Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined:
•
•
•
Phase 1: The drug is initially introduced into healthy human subjects or patients with the target disease or condition and
tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early
indication of its effectiveness.
Phase 2: The drug is administered to a limited patient population to identify possible adverse effects and safety risks, to
preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and
optimal dosage.
Phase 3: The drug is administered to an expanded patient population, generally at geographically dispersed clinical trial
sites, in well-controlled clinical trials to generate enough data to statistically evaluate the efficacy and safety of the
product for approval, to establish the overall risk-benefit profile of the product, and to provide adequate information for
the labeling of the product.
Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if
serious adverse events occur. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified
period, or at all. Furthermore, the FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds,
including a finding that the research subjects are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or
terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s
requirements or if the drug has been associated with unexpected serious harm to patients.
Marketing Approval
Assuming successful completion of the required clinical testing, the results of the preclinical and clinical studies, together with
detailed information relating to the product’s chemistry, manufacture, controls and proposed labeling, among other things, are
submitted to the FDA as part of an NDA requesting approval to market the product for one or more indications. In most cases, the
submission of an NDA is subject to a substantial application user fee. Under the Prescription Drug User Fee Act, or PDUFA,
guidelines that are currently in effect, the FDA has a goal of ten months from the date of “filing” of a standard NDA for a new
molecular entity to review and act on the submission. This review typically takes twelve months from the date the NDA is
submitted to the FDA because the FDA has 60 days to make a “filing” decision.
In addition, under the Pediatric Research Equity Act of 2003, or PREA, as amended and reauthorized, certain NDAs or
supplements to an NDA must contain data that are adequate to assess the safety and effectiveness of the drug for the claimed
indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for
which the product is safe and effective. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for
submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the
pediatric data requirements. The FDA also may require submission of a risk evaluation and mitigation strategy, or REMS, plan to
ensure that the benefits of the drug outweigh its risks. The REMS plan could include medication guides, physician communication
plans, assessment plans, and/or elements to assure safe use, such as restricted distribution methods, patient registries, or other risk
minimization tools.
The FDA conducts a preliminary review of all NDAs within the first 60 days after submission, before accepting them for filing, to
determine whether they are sufficiently complete to permit substantive review. The FDA may request additional information
rather than accept an NDA for filing. In this event, the application must be resubmitted with the additional information. The
resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing,
the FDA begins an in-depth substantive review. The FDA reviews an NDA to determine, among other things, whether the drug is
safe and effective and whether the facility in which it is manufactured, processed, packaged or held meets standards designed to
assure the product’s continued safety, quality and purity.
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The FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent
experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the
application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory
committee, but it considers such recommendations carefully when making decisions.
Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA
will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP
requirements and adequate to assure consistent production of the product within required specifications. Additionally, before
approving an NDA, the FDA may inspect one or more clinical trial sites to assure compliance with GCP requirements. After
evaluating the NDA and all related information, including the advisory committee recommendation, if any, and inspection reports
regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete
response letter. A complete response letter generally contains a statement of specific conditions that must be met in order to secure
final approval of the NDA and may require additional clinical or preclinical testing in order for FDA to reconsider the application.
Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the
regulatory criteria for approval. If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically
issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for
specific indications.
Even if the FDA approves a product, it may limit the approved indications for use of the product, require that contraindications,
warnings or precautions be included in the product labeling, require that post-approval studies, including Phase 4 clinical trials, be
conducted to further assess a drug’s safety after approval, require testing and surveillance programs to monitor the product after
commercialization, or impose other conditions, including distribution and use restrictions or other risk management mechanisms
under a REMS, which can materially affect the potential market and profitability of the product. The FDA may prevent or limit
further marketing of a product based on the results of post-marketing studies or surveillance programs. After approval, some types
of changes to the approved product, such as adding new indications, manufacturing changes, and additional labeling claims, are
subject to further testing requirements and FDA review and approval. Moreover, after approval of an NDA, a company may
decide to launch an “authorized generic” version of the drug, which is an approved brand name drug that is marketed without the
brand name on its label. Other than the fact that it does not have the brand name on its label, it is the exact same drug product as
the branded product. While a separate NDA is not required for marketing an authorized generic, the FDA requires that the NDA
holder notify the FDA if it markets an authorized generic. The NDA holder may market both the authorized generic and the brand-
name product at the same time.
Special FDA Expedited Review and Approval Programs
The FDA has various programs, including, but not limited to, fast track designation, accelerated approval, priority review, and
breakthrough therapy designation, which are intended to expedite or simplify the process for the development and FDA review of
drugs that are intended for the treatment of serious or life-threatening diseases or conditions and demonstrate the potential to
address unmet medical needs. The purpose of these programs is to provide important new drugs to patients earlier than under
standard FDA review procedures.
To be eligible for a fast track designation, the FDA must determine, based on the request of a sponsor, that a product is intended to
treat a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need. The FDA
will determine that a product will fill an unmet medical need if it will provide a therapy where none exists or provide a therapy
that may be potentially superior to existing therapy based on efficacy or safety factors. The FDA may review sections of the NDA
for a fast track product on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the
submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is
acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA. The FDA may give a
priority review designation to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy
exists. A priority review means that the goal for the FDA to review an application is six months, rather than the standard review of
ten months under current PDUFA guidelines. Under the new PDUFA agreement, these six and ten-month review periods are
measured from the “filing” date rather than the receipt date for NDAs for new molecular entities, which typically adds 60 days to
the timeline for review and decision from the date of submission. Most products that are eligible for fast track designation are also
likely to be considered appropriate to receive a priority review.
In addition, products studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide
meaningful therapeutic benefit over existing treatments may be eligible for accelerated approval and may be approved on the
basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is
reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or
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mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into
account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments. As a condition of
approval, the FDA may require a sponsor of a drug receiving accelerated approval to perform post-marketing studies to verify and
describe the predicted effect on irreversible morbidity or mortality or other clinical endpoint, and the drug may be subject to
accelerated withdrawal procedures.
Moreover, under the provisions of the Food and Drug Administration Safety and Innovation Act, or FDASIA, passed in July
2012, a sponsor can request designation of a product candidate as a “breakthrough therapy.” A breakthrough therapy is defined as
a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or
condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing
therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical
development. Drugs designated as breakthrough therapies are also eligible for accelerated approval. The FDA must take certain
actions, such as holding timely meetings and providing advice, intended to expedite the development and review of an application
for approval of a breakthrough therapy.
Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the
conditions for qualification or decide that the time period for FDA review or approval will not be shortened.
Post-Approval Regulation
Drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA,
including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution,
advertising and promotion and reporting of adverse experiences with the product. After approval, most changes to the approved
product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are
continuing, annual user fee requirements.
The FDA may impose a number of post-approval requirements as a condition of approval of an NDA. For example, the FDA may
require post-marketing testing, including Phase 4 clinical trials and surveillance to further assess and monitor the product’s safety
and effectiveness after commercialization.
In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to
register their establishments with the FDA and state agencies, and are subject to periodic unannounced inspections by the FDA
and these state agencies for compliance with cGMP. Changes to the manufacturing process are strictly regulated and often require
prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from
cGMP requirements and impose reporting and documentation requirements upon the sponsor and any third-party manufacturers
that the sponsor may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of
production and quality control to maintain cGMP compliance.
Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not
maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a
product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply
with regulatory requirements, may result in mandatory revisions to the approved labeling to add new safety information;
imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions
under a Risk Evaluation and Mitigation Strategies (“REMS”) program. Other potential consequences include, among other things:
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restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or
product recalls;
fines, warning letters or holds on post-approval clinical trials;
refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product
approvals;
product seizure or detention, or refusal to permit the import or export of products; or
injunctions or the imposition of civil or criminal penalties.
The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Drugs may
be promoted only for the approved indications and in accordance with the provisions of the approved label. The FDA and other
agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to
have improperly promoted off-label uses may be subject to significant liability.
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Medical Devices Regulation in the United States
Under the FFDCA, medical devices are classified into one of three classes—Class I, Class II or Class III—depending on the
degree of risk associated with each medical device and the extent of control needed to ensure safety and effectiveness. Class I
devices are those for which safety and effectiveness can be assured by adherence to the FDA’s general controls for medical
devices, which include compliance with the applicable portions of the FDA’s Quality System Regulation, or QSR, facility
registration and product listing, reporting of adverse medical events, and appropriate, truthful and non-misleading labeling,
advertising, and promotional materials. Some Class I devices also require premarket clearance by the FDA through the 510(k)
premarket notification process described below. Class II devices are subject to the FDA’s general controls, and any other special
controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. Premarket review and clearance by
the FDA for Class II devices is accomplished through the 510(k) premarket notification procedure, unless exempt. A Class III
product is a product which has a new intended use or uses advanced technology that is not substantially equivalent to that of a
legally marketed device. The safety and effectiveness of Class III devices cannot be assured solely by the General Controls and
the other requirements described above. These devices almost always require formal clinical studies to demonstrate safety and
effectiveness. Our current medical device products are classified as Class II medical devices.
When a 510(k) is required, the manufacturer must submit to the FDA a premarket notification submission demonstrating that the
device is “substantially equivalent” to either: a device that was legally marketed prior to May 28, 1976, the date upon which the
Medical Device Amendments of 1976 were enacted, and for which the FDA has not yet called for the submission of pre-market
approval applications (“PMAs”), or is a device that has been reclassified from Class III to either Class II or I.
If the FDA agrees that the device is substantially equivalent to a predicate device, it will grant clearance to commercially market
the device in the U.S. The FDA’s 510(k) clearance process usually takes from three to twelve months from the date the application
is submitted and filed with the FDA, but may take significantly longer and clearance is never assured. Although many 510(k) pre-
market notifications are cleared without clinical data, in some cases, the FDA requires significant clinical data to support
substantial equivalence. In reviewing a pre-market notification, the FDA may request additional information, including clinical
data, which may significantly prolong the review process. If the FDA determines that the device, or its intended use, is not
“substantially equivalent,” the FDA may deny the request for clearance. After a device receives 510(k) clearance, any subsequent
modification of the device that could significantly affect its safety or effectiveness, or that would constitute a major change in its
intended use, will require a new 510(k) clearance or could require pre-market approval. The FDA requires each manufacturer to
make this determination initially, but the FDA may review any such decision and may disagree with a manufacturer’s
determination. If the FDA disagrees with a manufacturer’s determination, the FDA may require the manufacturer to cease
marketing and/or recall the modified device until 510(k) clearance or pre-market approval is obtained. We have modified aspects
of some of our devices since receiving regulatory clearance and we have made the determination that new 510(k) clearances or
pre-market approvals were not required.
In addition, over the last several years, the FDA has proposed reforms to its 510(k) clearance process, and such proposals could
include increased requirements for clinical data and a longer review period, or could make it more difficult for manufacturers to
utilize the 510(k) clearance process for their products. For example, in November 2018, FDA officials announced forthcoming
steps that the FDA intends to take to modernize the premarket notification pathway under Section 510(k) of the FFDCA. Among
other things, the FDA announced that it planned to develop proposals to drive manufacturers utilizing the 510(k) pathway toward
the use of newer predicates. These proposals included plans to potentially sunset certain older devices that were used as predicates
under the 510(k) clearance pathway, and to potentially publish a list of devices that have been cleared on the basis of
demonstrated substantial equivalence to predicate devices that are more than 10 years old. In May 2019, the FDA solicited public
feedback on these proposals. These proposals have not yet been finalized or adopted, and the FDA may work with Congress to
implement such proposals through legislation.
More recently, in September 2019, the FDA finalized guidance describing an optional “safety and performance based” premarket
review pathway for manufacturers of “certain, well-understood device types” to demonstrate substantial equivalence under the
510(k) clearance pathway by showing that such device meets objective safety and performance criteria established by the FDA,
thereby obviating the need for manufacturers to compare the safety and performance of their medical devices to specific predicate
devices in the clearance process. The FDA intends to develop and maintain a list of device types appropriate for the “safety and
performance based” pathway and will continue to develop product-specific guidance documents that identify the performance
criteria for each such device type, as well as the testing methods recommended in the guidance documents, where feasible.
Although unlikely for the types of medical devices marketed by us, the FDA may classify the device, or the particular use of the
device, into Class III, and the device sponsor must then fulfill more rigorous PMA requirements. A PMA application, which is
intended to demonstrate that a device is safe and effective, must be supported by extensive data, including extensive technical and
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manufacturing data and data from preclinical studies and human clinical trials. After a PMA application is submitted and filed, the
FDA begins an in-depth review of the submitted information, which typically takes between one and three years, but may take
significantly longer. During this review period, the FDA may request additional information or clarification of information
already provided. Also, during the review period, an advisory panel of experts from outside the FDA will usually be convened to
review and evaluate the application and provide recommendations to the FDA as to the approvability of the device. In addition,
the FDA will conduct a pre-approval inspection of the manufacturing facility to ensure compliance with the QSR, which impose
elaborate design development, testing, control, documentation and other quality assurance procedures in the design and
manufacturing process. The FDA may approve a PMA application with post-approval conditions intended to ensure the safety and
effectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution and collection
of long-term follow-up data from patients in the clinical study that supported approval. Failure to comply with the conditions of
approval can result in materially adverse enforcement action, including the loss or withdrawal of the approval. New PMA
applications or PMA supplements are required for significant modifications to the manufacturing process, labeling of the product
and design of a device that is approved through the PMA process. PMA supplements often require submission of the same type of
information as an original PMA, except that the supplement is limited to information needed to support any changes from the
device covered by the original PMA, and may not require as extensive clinical data or the convening of an advisory panel.
A clinical trial is typically required to support a PMA application and is sometimes required for a 510(k) pre-market notification.
Clinical trials generally require submission of an application for an Investigational Device Exemption, or IDE, to the FDA. The
IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test
the device in humans and that the investigational protocol is scientifically sound. The IDE application must be approved in
advance by the FDA for a specified number of patients, unless the product is deemed a non-significant risk device and eligible for
more abbreviated IDE requirements. Clinical trials for a significant risk device may begin once the IDE application is approved
by the FDA as well as the appropriate institutional review boards at the clinical trial sites, and the informed consent of the patients
participating in the clinical trial is obtained. After a trial begins, the FDA may place it on hold or terminate it if, among other
reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk. Any trials we conduct must be
conducted in accordance with FDA regulations as well as other federal regulations and state laws concerning human subject
protection and privacy.
In addition, after a device is placed on the market, numerous FDA and other regulatory requirements continue to apply. These
include establishment registration and device listing with the FDA; compliance with medical device reporting regulations, which
require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or
malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur; and compliance with
corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections and product
recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FFDCA that may
present a risk to health. The FDA and the Federal Trade Commission also regulate the advertising and promotion of our products
to ensure that the claims we make are consistent with our regulatory clearances, that there is scientific data to substantiate the
claims and that our advertising is neither false nor misleading. In general, we may not promote or advertise our products for uses
not within the scope of our intended use statement in our clearances or make unsupported safety and effectiveness claims. Many
regulatory jurisdictions outside of the United States have similar regulations to which we are subject.
Foreign Regulation of Drugs and Medical Devices
In order for us to market our products in countries outside the United States, we must obtain regulatory approvals and comply
with extensive product and quality system regulations in other countries. These regulations, including the requirements for
approvals or clearance and the time required for regulatory review, vary from country to country. Some countries have regulatory
review processes which are substantially longer than U.S. processes. Failure to obtain regulatory authorizations or approvals in a
timely manner and to meet all local requirements including language and specific safety standards in any foreign country in which
we plan to market our products could prevent us from marketing products in such countries or subject us to sanctions and fines.
Commercialization of medical devices in Europe is regulated by the EU. The EU presently requires that all medical products bear
the Conformité Européenne (“CE”) mark, for compliance with the Medical Device Directive (93/42/EEC) as amended. The CE
mark is an international symbol of adherence to certain essential principles of safety and performance mandated in applicable
European medical device directives, which once affixed, enables a product to be sold in member countries of the EU and those
affiliated countries which accept the CE mark. The CE mark is also recognized in many countries outside of the EU, such as
Australia, and can assist in the clearance process. In order to affix the CE mark on products, a recognized European Notified Body
must certify a manufacturer’s quality system and design dossier for compliance with international and European requirements. To
maintain authorization to apply the CE mark, we are subject to annual surveillance audits and periodic re-certification audits. In
September 2013, the European Commission adopted a recommendation indicating that all Notified Bodies, including Presafe, an
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accredited certification body, should carry out unannounced audits, at least once every third year, of the manufacturers whose
medical devices they have certified. These unannounced audits can also extend to the manufacturer’s critical suppliers or sub-
contractors (those that supply a critical input or perform a critical function for the manufacturer).
Federal, State and Foreign Fraud and Abuse and Physician Payment Transparency Laws
We are also subject to federal and state healthcare laws and regulations pertaining to fraud and abuse, physician payment
transparency, privacy, and security laws and regulations. These laws include, without limitation: foreign, federal, and state anti-
kickback and false claims laws, as well as transparency laws regarding payments or other items of value provided to healthcare
providers. The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or
receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind
to induce or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any good,
facility, item or service reimbursable, in whole or in part, under Medicare, Medicaid or other federal healthcare programs. The
term “remuneration” has been broadly interpreted to include anything of value, including stock, stock options and the
compensation derived through ownership interests.
Recognizing that the federal Anti-Kickback Statute is broad and may prohibit many innocuous or beneficial arrangements within
the healthcare industry, the Department of Health and Human Services issued regulations in July 1991, which the Department has
referred to as “safe harbors.” These safe harbor regulations set forth certain provisions which, if met in form and substance, will
assure pharmaceutical, biotechnology and medical device manufacturers, healthcare providers and other parties that they will not
be prosecuted under the federal Anti-Kickback Statute. Additional safe harbor provisions providing similar protections have been
published intermittently since 1991. Although there are a number of statutory exceptions and regulatory safe harbors protecting
some common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Practices that involve
remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny
if they do not qualify for an exception or safe harbor. Failure to meet all of the requirements of a particular applicable statutory
exception or regulatory safe harbor does not make the conduct per se illegal under the federal Anti-Kickback Statute. Instead, the
legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all its facts and
circumstances. Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement
involving remuneration is to induce referrals of federal healthcare covered business, the federal Anti-Kickback Statute has been
violated. In addition, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in
order to have committed a violation. Moreover, a claim including items or services resulting from a violation of the federal Anti-
Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act (described below).
Violations of the federal Anti-Kickback Statute may result in civil monetary penalties, plus up to three times the remuneration
involved. Civil penalties for such conduct can further be assessed under the federal False Claims Act. Violations can also result in
criminal penalties, including criminal fines and imprisonment. Similarly, violations can result in exclusion from participation in
government healthcare programs, including Medicare and Medicaid. Liability under the federal Anti-Kickback Statute may also
arise because of the intentions or actions of the parties with whom we do business. Conduct and business arrangements that do not
fully satisfy one of these safe harbor provisions may result in increased scrutiny by government enforcement authorities. The
majority of states also have anti-kickback laws which establish similar prohibitions and, in some cases may apply more broadly to
items or services covered by any third-party payor, including commercial insurers and self-pay patients.
The federal civil False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be
presented, a false or fraudulent claim for payment or approval to the federal government or knowingly making, using or causing
to be made or used a false record or statement material to a false or fraudulent claim to the federal government. A claim includes
“any request or demand” for money or property presented to the U.S. government. The federal civil False Claims Act also applies
to false submissions that cause the government to be paid less than the amount to which it is entitled, such as a rebate. Intent to
deceive is not required to establish liability under the civil federal civil False Claims Act.
In addition, private parties may initiate “qui tam” whistleblower lawsuits against any person or entity under the federal civil False
Claims Act in the name of the government and share in the proceeds of the lawsuit. Penalties for federal civil False Claim Act
violations include fines for each false claim, plus up to three times the amount of damages sustained by the federal government
and, most critically, may provide the basis for exclusion from the federally funded healthcare program. On May 20, 2009, the
Fraud Enforcement Recovery Act of 2009, or FERA, was enacted, which modifies and clarifies certain provisions of the federal
civil False Claims Act. In part, the FERA amends the federal civil False Claims Act such that penalties may now apply to any
person, including an organization that does not contract directly with the government, who knowingly makes, uses or causes to be
made or used, a false record or statement material to a false or fraudulent claim paid in part by the federal government. The
government may further prosecute conduct constituting a false claim under the federal criminal False Claims Act. The criminal
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False Claims Act prohibits the making or presenting of a claim to the government knowing such claim to be false, fictitious or
fraudulent and, unlike the federal civil False Claims Act, requires proof of intent to submit a false claim. When an entity is
determined to have violated the federal civil False Claims Act, the government may impose civil fines and penalties, plus treble
damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs.
The federal Civil Monetary Penalty Act of 1981 imposes penalties against any person or entity that, among other things, is
determined to have presented or caused to be presented a claim to a federal healthcare program that the person knows or should
know is for an item or service that was not provided as claimed or is false or fraudulent, or offering or transferring remuneration
to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or
receive items or services reimbursable by the government from a particular provider or supplier.
The Health Insurance Portability and Accountability Act of 1996, or HIPAA, also created additional federal criminal statutes that
prohibit among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare
benefit program, including private third-party payors; knowingly and willfully embezzling or stealing from a healthcare benefit
program; willfully obstructing a criminal investigation of a healthcare offense; and knowingly and willfully falsifying, concealing
or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of
or payment for healthcare benefits, items or services. Similar to the federal Anti-Kickback Statute, a person or entity does not
need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
Many foreign countries have similar laws relating to healthcare fraud and abuse. Foreign laws and regulations may vary greatly
from country to country. For example, the advertising and promotion of our products is subject to EU Directives concerning
misleading and comparative advertising and unfair commercial practices, as well as other EEA Member State legislation
governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our
products to the general public and may impose limitations on our promotional activities with healthcare professionals. Also, many
U.S. states have similar fraud and abuse statutes or regulations that may be broader in scope and may apply regardless of payor, in
addition to items and services reimbursed under Medicaid and other state programs.
Additionally, there has been a recent trend of increased foreign, federal, and state regulation of payments and transfers of value
provided to healthcare professionals or entities. The federal Physician Payments Sunshine Act imposes annual reporting
requirements on certain drug, biologics, medical supplies and device manufacturers for which payment is available under
Medicare, Medicaid or Children’s Health Insurance Program for payments and other transfers of value provided by them, directly
or indirectly, to physicians (including physician family members) and teaching hospitals, as well as ownership and investment
interests held by physicians and their immediate family members. A manufacturer’s failure to submit timely, accurately and
completely the required information for all payments, transfers of value or ownership or investment interest may result in civil
monetary penalties. Manufacturers must submit reports by the 90th day of each calendar year. Certain foreign countries and U.S.
states also mandate implementation of commercial compliance programs, impose restrictions on device manufacturer marketing
practices and require tracking and reporting of gifts, compensation and other remuneration to healthcare professionals and
entities.
Coverage and reimbursement
In the United States and markets in other countries, patients who are prescribed treatments for their conditions and providers
performing the prescribed services generally rely on third-party payors to reimburse all or part of the associated healthcare costs.
Patients are unlikely to use our products or the products for which we receive royalty revenue unless coverage is provided, and
reimbursement is adequate to cover a significant portion of the cost. Sales of any products therefore depend, in part, on the
availability of coverage and adequate reimbursement from third-party payors. Third-party payors include government authorities,
managed care plans, private health insurers and other organizations.
The process for determining whether a third-party payor will provide coverage for a pharmaceutical or device product typically is
separate from the process for setting the price of such product or for establishing the reimbursement rate that the payor will pay
for the product once coverage is approved. Third-party payors may limit coverage to specific products on an approved list, also
known as a formulary, which might not include all of the FDA-approved products for a particular indication. A decision by a
third-party payor not to cover our products could reduce physician utilization of our products and have a material adverse effect
on our sales, results of operations and financial condition. Moreover, a third-party payor’s decision to provide coverage for a
pharmaceutical or device product does not imply that an adequate reimbursement rate will be approved. Adequate third-party
reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our
investment in product development. Additionally, coverage and reimbursement for products can differ significantly from payor to
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payor. One third-party payor’s decision to cover a particular medical product or service does not ensure that other payors will also
provide coverage for the medical product or service, or will provide coverage at an adequate reimbursement rate.
For our medical device business, the reimbursement to the facility from third-party payors is intended to cover the overall cost of
treatment, including the cost of our devices used during the procedure as well as the overhead cost associated with the facility
where the procedure is performed. We do not directly bill any third-party payors; instead, we receive payment from the hospital or
other facility that uses our devices. Failure by physicians, hospitals, and other users of our devices to obtain sufficient coverage
and reimbursement from healthcare payors for procedures in which our devices are used, or adverse changes in government and
private third-party payors’ policies could have a material adverse effect on our business, financial condition, results of operations
and future growth prospects.
In addition, there are periodic changes to reimbursement. Third-party payors regularly update reimbursement amounts and also
from time to time revise the methodologies used to determine reimbursement amounts. This includes annual updates to payments
to physicians, hospitals and other facilities for procedures during which our devices are used. Because the cost of our devices
generally is recovered by the healthcare provider as part of the payment for performing a procedure and not separately
reimbursed, these updates could directly impact the demand for our devices. An example of such payment updates is the Medicare
program’s updates to hospital and physician payments, which are done on an annual basis using a prescribed statutory formula. In
the past, with respect to reimbursement for physician services under the Medicare Physician Fee Schedule, when the application
of the formula resulted in lower payment, Congress has passed interim legislation to prevent the reductions.
The containment of healthcare costs is a priority of federal, state and foreign governments, and the prices of pharmaceutical or
device products have been a focus in this effort. Third-party payors are increasingly challenging the prices charged for medical
products and services, examining the medical necessity and reviewing the cost-effectiveness of pharmaceutical products, medical
devices and medical services, in addition to questioning safety and efficacy. If these third-party payors do not consider our
products to be cost-effective compared to other available therapies, they may not cover our products or, if they do, the level of
payment may not be sufficient to allow us to sell our products at a profit.
Healthcare Reform
The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals
to change the healthcare system in ways that could affect our ability to sell our products profitably. Among policy makers and
payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated
goals of containing healthcare costs, improving quality or expanding access. Current and future legislative proposals to further
reform healthcare or reduce healthcare costs may limit coverage of or lower reimbursement for the procedures associated with the
use of our products. The cost containment measures that payors and providers are instituting, and the effect of any healthcare
reform initiative implemented in the future could impact our revenue from the sale of our products.
The implementation of the Affordable Care Act, (the “ACA”), in the United States, for example, has changed healthcare financing
and delivery by both governmental and private insurers substantially, and affected medical device manufacturers significantly.
The ACA imposed, among other things, a 2.3% federal excise tax, with limited exceptions, on any entity that manufactures or
imports Class I, II and III medical devices offered for sale in the United States that began on January 1, 2013. Through a series of
legislative amendments, the tax was suspended for 2016 through 2019. The device excise tax was repealed on December 20,
2019. The ACA also provided incentives to programs that increase the federal government’s comparative effectiveness research,
and implemented payment system reforms including a national pilot program on payment bundling to encourage hospitals,
physicians and other providers to improve the coordination, quality and efficiency of certain healthcare services through bundled
payment models. Additionally, the ACA has expanded eligibility criteria for Medicaid programs and created a new Patient-
Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research,
along with funding for such research. We do not yet know the full impact that the ACA will have on our business.
There have been judicial and Congressional challenges to certain aspects of the ACA, and we expect additional challenges and
amendments in the future. Moreover, the Trump Administration and the U.S. Congress may take further action regarding the
ACA, including, but not limited to, repeal or replacement.
Moreover, other legislative changes have been proposed and adopted since the ACA was enacted. For example, the Budget
Control Act of 2011, among other things, included reductions to Medicare payments to providers of 2% per fiscal year, which
went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2025
unless additional Congressional action is taken. Additionally, the American Taxpayer Relief Act of 2012, among other things,
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reduced Medicare payments to several providers, including hospitals, and increased the statute of limitations period for the
government to recover overpayments to providers from three to five years.
We expect additional state and federal healthcare reform measures to be adopted in the future, any of which could limit the
amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand
for our products or additional pricing pressure.
In addition, changes in existing regulations could have a material adverse effect on us or our licensees, borrowers or royalty-
agreement counterparties. For a discussion of the risks associated with government regulations, see Item 1A, “Risk Factors.”
Manufacturing
Our manufacturing processes are required to comply with the FDA’s cGMP requirements, which for medical devices, are
contained in its QSR and associated regulations and guidance. The QSR covers, among other things, the methods used in, and the
facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all medical
devices intended for human use. The QSR also requires maintenance of extensive records which demonstrate compliance with
FDA regulation, the manufacturer’s own procedures, specifications, and testing as well as distribution and post-market
experience. Compliance with the QSR is necessary to receive FDA clearance or approval to market new products and is necessary
for a manufacturer to be able to continue to market cleared or approved product offerings in the United States. A company’s
facilities, records, and manufacturing processes are subject to periodic scheduled or unscheduled inspections by the FDA, which
may issue reports known as Forms FDA 483 or Notices of Inspectional Observations which list instances where the FDA
inspector believes the manufacturer has failed to comply with applicable regulations and/or procedures. If the observations are
sufficiently serious or the manufacturer fails to respond appropriately, the FDA may issue Warning Letters, or Untitled Letters,
which are notices of potential enforcement actions against the manufacturer. If a Warning Letter or Untitled Letter is not
addressed to the satisfaction of the FDA, or if the FDA becomes aware of any other serious issue with a manufacturer’s products
or facilities, it could result in fines, injunctions, civil penalties, delays, suspension or withdrawal of clearances, seizures or recalls
of products, operating restrictions, total shutdown of production facilities, prohibition on export or import and criminal
prosecution. Such actions may have further indirect consequences for the manufacturer outside of the United States, and may
adversely affect the reputation of the manufacturer and the product. In the United States, routine FDA inspections usually occur
every two years, and may occur more often for cause.
To a greater or lesser extent, most other countries require some form of quality system and regulatory compliance, which may
include periodic inspections, inspections by third-party auditors, and specialized documentation. Failure to meet all the
requirements of these countries could jeopardize our ability to import, market, support, and receive reimbursement for the use of
our products in these countries. In addition to the above, we may seek to conduct clinical studies or trials in the United States or
other countries on products that have not yet been cleared or approved for a particular indication. Products manufactured outside
the United States by or for us are subject to U.S. Customs and FDA inspection upon entry into the United States. We must
demonstrate compliance of such products to U.S. regulations and carefully document the eventual distribution or re-exportation of
such products. Failure to comply with all applicable regulations could prevent us from having access to products or components
critical to the manufacture of finished products and lead to shortages and delays.
Employees
As of December 31, 2019, we had 20 full-time employees managing our intellectual property, acquisitions, operations and other
corporate activities, including providing management oversight, accounting, legal and tax support and administrative assistance to
our subsidiaries, as well as performing certain essential functions of a public company. In addition, we had 89 full-time employees
at our subsidiaries, Noden and LENSAR, who manage the subsidiaries’ businesses and operations. Geographically, 96 employees
were based in the United States and 13 employees were located internationally. None of our employees are covered by a
collective bargaining agreement, and we consider our relationship with our employees to be good.
About PDL
We were incorporated under the laws of the state of Delaware in 1986 under the name Protein Design Labs, Inc. In 2006, we
changed our name to PDL BioPharma, Inc. Our business previously included a biotechnology operation that was focused on the
discovery and development of novel antibodies. We spun-off the operation to our stockholders as Facet Biotech Corporation
(“Facet”) in December 2008. Our principal executive offices are located at 932 Southwood Boulevard, Incline Village, Nevada,
89451, (775) 832-8500, and our website address is www.pdl.com. The information in or accessible through our website is not
incorporated into, and is not considered part of, this filing.
17
Available Information
We file electronically with the SEC our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on
Form 8-K pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended. The SEC maintains an Internet
site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with
the SEC. The address of that website is www.sec.gov.
We make available free of charge on or through our website at www.pdl.com our Annual Reports on Form 10-K, Quarterly
Reports on Form 10-Q, Current Reports on Form 8-K and proxy statements, as well as amendments to these reports and
statements, as soon as practicable after we have electronically filed such material with, or furnished them to, the SEC. You may
also obtain copies of these filings free of charge by calling us at (775) 832-8500. Also, our Audit Committee Charter,
Compensation Committee Charter, Nominating and Governance Committee Charter, Litigation Committee Charter, Corporate
Governance Guidelines and Code of Business Conduct, as well as amendments thereto, are also available free of charge on our
website or by calling the number listed above. The information in or accessible through the SEC and our website is not
incorporated into, and is not considered part of, this filing.
18
ITEM 6. SELECTED CONSOLIDATED FINANCIAL DATA
PART II
The following selected consolidated financial information has been derived from our Consolidated Financial Statements. The
selected historical statements of operations data for the fiscal years ended December 31, 2019, 2018 and 2017 and balance sheet
data as of December 31, 2019 and 2018 have been derived from our audited consolidated financial statements included elsewhere
in this Form 8-K. The selected historical statements of operations data for the fiscal years ended December 31, 2016 and 2015 and
balance sheet data as of December 31, 2017, 2016 and 2015, as recast for discontinued operations, are unaudited and have been
derived from our accounting records. The information below is not necessarily indicative of the results of future operations and
should be read in conjunction with the consolidated financial statements, related notes, and other financial information included
therein.
Consolidated Statements of Operations Data
(in thousands, except per share data)
Revenues:
Product revenue, net ......................................................................
Royalty rights - change in fair value .............................................
Royalties from Queen et al. patents...............................................
Interest revenue .............................................................................
License and other...........................................................................
Total revenues...........................................................................
Operating expenses:
Cost of product revenue (excluding intangible asset
amortization)..................................................................................
Amortization of intangible assets ..................................................
General and administrative expenses ............................................
Sales and marketing.......................................................................
Research and development ............................................................
Asset impairment loss....................................................................
Loss on extinguishment of notes receivable..................................
Change in fair value of anniversary payment and contingent
consideration..................................................................................
Total operating expenses...........................................................
Operating (loss) income ................................................................
Non-operating income (expense), net:
Equity affiliate - change in fair value .......................................
Gain on bargain purchase .........................................................
Other non-operating expense, net .............................................
Non-operating income (expense), net.......................................
(Loss) income before income taxes....................................................
Income tax (benefit) expense.........................................................
Net (loss) income from continuing operations ...................................
(Loss) income from discontinued operations before income
taxes...............................................................................................
Income tax (benefit) expense of discontinued operations .............
(Loss) income from discontinued operations .....................................
Net (loss) income...............................................................................
Less: Net (loss) income attributable to noncontrolling interests ...
19
2019
$ 30,742
—
9
—
(45)
30,706
17,276
1,290
38,539
6,806
7,350
10,768
—
—
82,029
(51,323)
36,402
—
(10,328)
26,074
(25,249)
(1,021)
(24,228)
(48,491)
(2,028)
(46,463)
(70,691)
(280)
For the Years Ended December 31,
2017
2016
2018
2015
$ 24,652
(30)
4,536
2,337
533
32,028
13,555
1,294
33,700
6,341
2,759
8,200
—
369
66,218
(34,190)
$ 15,091
$
— $
—
2,598
36,415
17,744
19,451
91,299
12,204
632
16,413
4,078
166,158
485,156
30,404
(126)
212,849
36,202
723
526,159
—
—
—
—
35,373
37,660
35,920
3,663
1,418
—
—
—
—
—
—
—
—
—
51,075
3,979
—
—
53,290
38,009
88,735
39,899
124,114
486,260
—
—
—
—
(5,328)
(5,328)
(39,518)
(6,753)
(32,765)
(16,405)
19,689
(36,094)
(68,859)
—
9,309
(18,562)
(9,253)
28,756
15,404
13,352
155,770
58,421
97,349
110,701
(47)
—
(20,032)
(20,032)
104,082
38,725
65,357
5,288
6,986
(1,698)
63,659
53
—
—
(20,241)
(20,241)
466,019
174,926
291,093
64,118
22,416
41,702
332,795
—
(in thousands, except per share data)
Net (loss) income attributable to PDL’s stockholders ........................
For the Years Ended December 31,
2017
2016
2019
2018
$ (70,411) $ (68,859) $ 110,748
$ 63,606
$ 332,795
2015
Net (loss) income per basic share:
Net (loss) income from continuing operations .........................
Net (loss) income from discontinued operations ......................
Net (loss) income attributable to PDL’s shareholders per
basic share ....................................................................................
Net (loss) income per diluted share:
Net (loss) income from continuing operations .........................
Net (loss) income from discontinued operations ......................
Net (loss) income attributable to PDL’s shareholders per
diluted share.................................................................................
Cash dividends declared and paid .................................................
$
$
$
$
$
$
$
Consolidated Balance Sheet Data
(0.20) $
(0.39) $
(0.22) $
(0.25) $
0.09
0.62
(0.59) $
(0.47) $
0.71
(0.20) $
(0.39) $
(0.22) $
(0.25) $
0.09
0.62
(0.59) $
(0.47) $
0.71
$
$
$
$
$
$
0.40
$
(0.01) $
1.78
0.26
0.39
$
2.04
$
0.40
(0.01) $
0.39
$
$
1.78
0.25
2.03
0.60
— $
— $
— $
0.10
December 31,
(in thousands)
2019
2018
2017
2016
2015
Cash, cash equivalents, short-term investments and
restricted investments......................................................
Current assets held for sale...................................................
Long-term assets held for sale..............................................
Total assets ...........................................................................
Current liabilities held for sale .............................................
Long-term liabilities held for sale ........................................
Total liabilities......................................................................
Retained earnings .................................................................
Total stockholders’ equity ....................................................
$ 168,982
$ 365,680
$ 492,362
$ 224,846
$ 220,352
$
70,366
$
65,143
$
73,086
$
55,753
$
—
$ 281,087
$ 420,046
$ 558,640
$ 522,151
$ 346,621
$ 717,206
$ 965,508
$1,246,107
$1,215,387
$1,012,205
$
$
31,095
120
$
$
40,700
$
51,540
$ 117,395
— $
42,000
$
42,650
$
$
—
—
$ 123,928
$ 235,729
$ 400,217
$ 459,964
$ 316,253
$ 670,832
$ 828,547
$ 945,614
$ 857,116
$ 810,036
$ 593,278
$ 729,779
$ 845,890
$ 755,423
$ 695,952
20
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with
“Selected Consolidated Financial Data” and the Consolidated Financial Statements and related Notes included elsewhere in this
Form 8-K.
Overview
Throughout our history, our mission has been to improve the lives of patients by aiding in the successful development of
innovative therapeutics and healthcare technologies. PDL BioPharma was founded in 1986 as Protein Design Labs, Inc. when it
pioneered the humanization of monoclonal antibodies, enabling the discovery of a new generation of targeted treatments that have
had a profound impact on patients living with different cancers as well as a variety of other debilitating diseases. In 2006, we
changed our name to PDL BioPharma, Inc.
In September 2019, we engaged financial and legal advisors and initiated a review of our strategy. This review was completed in
December 2019. At such time, we disclosed that we planned to halt the execution of our growth strategy, cease making additional
strategic transactions and investments and pursue a formal process to unlock the value of our portfolio by monetizing our assets
and ultimately distributing net proceeds to stockholders. Over the subsequent months, our Board and management analyzed,
together with our outside financial and legal advisors, how to best capture value pursuant to our monetization strategy and best
return the significant intrinsic value of the high-quality assets in our portfolio to the stockholders. In February of 2020, our Board
approved a plan of complete liquidation of our assets and passed a resolution to seek stockholder approval to dissolve the
Company under Delaware law at its next annual meeting of the stockholders. In the event that the Board concludes that the whole
Company sale process is unlikely to maximize the value that can be returned to the stockholders from our monetization process,
we would, if approved by the stockholders, file a Certificate of Dissolution in Delaware and proceed to wind-down and dissolve
the Company in accordance with Delaware law. Pursuant to our monetization strategy, we are exploring a variety of potential
transactions, including a whole company sale, divestiture of assets, spin-offs of operating entities, merger opportunities or a
combination thereof. In addition, we have analyzed, and continue to analyze, the optimal mechanisms for returning value to
stockholders in a tax-efficient manner, including via share repurchases, cash dividends and other distributions of assets. We have
not set a definitive timeline and intend to pursue monetization in a disciplined and cost-effective manner to maximize returns to
stockholders. We recognize, however, that accelerating the timeline, while continuing to optimize asset value, could increase
returns to stockholders due to reduced general and administrative expenses as well as provide faster returns to stockholders.
While, as noted above, we cannot provide a definitive timeline for the monetization and wind-down process, we are targeting the
end of 2020 for completing the monetization of our key assets, at which time we may be in a position to file a certificate of
dissolution under Delaware law.
Historically, we generated a substantial portion of our revenues through the license agreements related to patents covering the
humanization of antibodies, which we refer to as the Queen et al. patents. In 2012, we began providing alternative sources of
capital through royalty monetizations and debt facilities, and, in 2016, we began acquiring commercial-stage products and
launching specialized companies dedicated to the commercialization of these products, first with our acquisition of branded
prescription pharmaceutical drugs from Novartis in 2016 and, in 2017, with the acquisition of LENSAR, a medical device
ophthalmology equipment manufacturing company. In 2019, we entered into a securities purchase agreement with Evofem,
pursuant to which we invested $60.0 million in a private placement of securities. Based on the nature of our investments, our
operations were structured in four segments designated as Income Generating Assets, Pharmaceutical, Medical Devices and
Strategic Positions.
As noted above, the information in this Form 8-K, including our segment information, relates only to our continuing operations.
Therefore, the Pharmaceutical segment and the royalty right assets within the Income Generating Assets segment are not
discussed herein as they meet the criteria to be classified as held for sale and are included as discontinued operations.
We are considering various strategic options with respect to the rest of our business. Because our remaining operating business,
specifically LENSAR, and other investments, primarily our notes receivable included in our Income Generating Assets segment
and Evofem, do not meet the criteria to be classified as held for sale or a discontinued operation, they continue to be included in
our continuing operations. In the second quarter of 2020, we distributed our shares of common stock in Evofem to our
stockholders but retained the warrants to acquire shares of Evofem common stock.
21
To date, we have consummated a number of transactions, of which the following are active and included in continuing operations:
Investment
Investment Type
Segment
LENSAR, Inc. (“LENSAR”) ........................................ Converted equity and loan
Medical Devices
$
Evofem ..........................................................................
CareView communications, Inc. (“CareView”) ............
Wellstat Diagnostics, LLC (“Wellstat Diagnostics”) 1..
Equity
Debt
Strategic Positions
$
Income Generating Assets $
Royalty/debt hybrid
Income Generating Assets
$
Deployed
Capital 2
(in millions)
47.0
60.0
20.0
44.0
_______________
1. Also known as Defined Diagnostic, LLC. The Wellstat Diagnostics investment also includes our note receivable
with Hyperion Catalysis International, Inc. (“Hyperion”).
2. Excludes transaction costs.
Our Medical Devices segment consists of revenue derived from the sale and lease of the LENSAR® Laser System, which may
include equipment, PIDs, procedure licenses, training, installation, warranty and maintenance agreements. Our Strategic Positions
segment consists of an investment in Evofem. Our Evofem investment includes shares of common stock and warrants to purchase
additional shares of common stock. Evofem is a pre-commercial company and, as such, is not yet engaged in revenue-generating
activities. Our Income Generating Assets segment consists of revenue derived from (i) notes and other long-term receivables, (ii)
equity investments and (iii) royalties from issued patents in the United States and elsewhere covering the humanization of
antibodies, which we refer to as the Queen et al. patents.
Prospectively, we do not expect to make any additional acquisitions as we pursue our monetization strategy. We do, however,
expect to continue supporting the development of LENSAR’s next generation equipment by providing necessary funding.
Critical Accounting Policies and Significant Estimates
The preparation of financial statements and related disclosures in conformity with U.S. Generally Accepted Accounting Principles
(“GAAP”) and the discussion and analysis of our financial condition and operating results require our management to make
judgments, assumptions and estimates that affect the amounts reported in its Consolidated Financial Statements and
accompanying notes. Note 2, Summary of Significant Accounting Policies, to the Consolidated Financial Statements included in
this Form 8-K describes the significant accounting policies and methods used in the preparation of our Consolidated Financial
Statements. Management bases its estimates on historical experience and on various other assumptions it believes to be
reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets
and liabilities. Actual results may differ from these estimates and such differences may be material.
While our significant accounting policies are more fully described in the notes to our Consolidated Financial Statements
appearing elsewhere in this Form 8-K, management believes that the following accounting policies related to assets and liabilities
held for sale, discontinued operations, notes receivable and other long-term receivables, inventory, intangible assets, convertible
notes, product revenue, royalty rights - at fair value, income taxes, and business combination are critical because they are both
important to the portrayal of our financial condition and operating results, and they require management to make judgments and
estimates about inherently uncertain matters.
Assets Held for Sale
Assets and liabilities are classified as held for sale and presented separately on the balance sheet when all of the following criteria
for a plan of sale have been met: (1) management, having the authority to approve the action, commits to a plan to sell the assets;
(2) the assets are available for immediate sale, in their present condition, subject only to terms that are usual and customary for
sales of such assets; (3) an active program to locate a buyer and other actions required to complete the plan to sell the assets have
been initiated; (4) the sale of the assets is probable and is expected to be completed within one year; (5) the assets are being
actively marketed for a price that is reasonable in relation to their current fair value; and (6) actions required to complete the plan
indicate that it is unlikely that significant changes to the plan will be made or the plan will be withdrawn. The Pharmaceutical
segment and certain royalty right assets within the Income Generating Assets segment are classified as held for sale. The royalty
right assets held for sale are Assertio, Viscogliosi Brothers, University of Michigan, AcelRx, and Kybella. The assets and
liabilities held for sale are recorded on the Company’s Consolidated Balance Sheets as Assets held for sale and Liabilities held for
sale, respectively.
22
Discontinued Operations
Discontinued operations comprise those activities that were disposed of during the period or which were classified as held for sale
at the end of the period, represent a separate major line of business or geographical area that can be clearly distinguished for
operational and financial reporting purposes and represents a strategic shift that has or will have a major effect on the Company’s
operations and financial results. The profits and losses of the investments classified as held for sale, the Pharmaceutical segment,
and certain royalty assets noted above, are presented on the Consolidated Statements of Operations as discontinued operations.
See Note 3, Discontinued Operations Classified as Assets Held for Sale, for additional information.
Notes Receivable and Other Long-Term Receivables
We account for our notes receivable at amortized cost, net of unamortized origination fees, if any, and adjusted for any
impairment losses. Interest is accreted or accrued to “Interest revenue” using the effective interest method. When and if
supplemental payments are received from certain of these notes and other long-term receivables, an adjustment to the estimated
effective interest rate is affected prospectively.
We evaluate the collectability of both interest and principal for each note receivable or loan to determine whether it is impaired. A
note receivable or loan is considered to be impaired when, based on current information and events, we determine it is probable
that it will be unable to collect amounts due according to the existing contractual terms. When a note receivable or loan is
considered to be impaired, the amount of loss is calculated by comparing the carrying value of the financial asset to the value
determined by discounting the expected future cash flows at the loan’s effective interest rate or to the estimated fair value of the
underlying collateral, less costs to sell, if the loan is collateralized and we expect repayment to be provided solely by the
collateral. Impairment assessments require significant judgments and are based on significant assumptions related to the
borrower’s credit risk, financial performance, expected sales, and estimated fair value of the collateral.
We record interest on an accrual basis and recognize it as earned in accordance with the contractual terms of the applicable credit
agreement, to the extent that the underlying note receivable or loan is not impaired and such amounts are expected to be
collected. When a note receivable or loan becomes past due, or if management otherwise does not expect that principal, interest,
and other obligations due will be collected in full, we will generally place the note receivable or loan on an impaired status and
cease recognizing interest income on that note receivable or loan until all principal and interest due has been paid or until such
time that we believe the borrower has demonstrated the ability to repay its current and future contractual obligations. Any
uncollected interest related to prior periods is reversed from income in the period that collection of the interest receivable is
determined to be doubtful. However, we may make exceptions to this policy if the investment has sufficient collateral value and is
in the process of collection.
As of December 31, 2019, we had three notes receivable investments which we determined to be impaired with an aggregate
carrying value and fair value of approximately $52.1 million and $57.3 million, respectively, compared to three note receivable
investments which we determined to be impaired as of December 31, 2018 with an aggregate carrying value and fair value of
approximately $62.8 million and $70.0 million, respectively. We did not recognize any losses on extinguishment of notes
receivable during the years ended December 31, 2019 and 2018. During the year ended December 31, 2017, we recognized a loss
on extinguishment of notes of $51.1 million. During the years ended December 31, 2019 and 2018, we recorded impairment
losses of $10.8 million and $8.2 million, respectively, related to the CareView note receivable. There were no impairment losses
on notes receivable for the year ended December 31, 2017. For the year ended December 31, 2019, we did not recognize any
interest income for note receivable investments as all such note receivable investments were on an impaired status and no cash
interest payments were received. For the years ended December 31, 2018 and 2017, we recognized $2.3 million and $3.1 million,
respectively, of interest revenue for the CareView note receivable investment as result of cash interest payments made during the
respective fiscal years.
Inventory
Inventory, which consists of raw materials, work-in-process and finished goods, is stated at the lower of cost or net realizable
value. We determine cost using the first-in, first-out method. Inventory levels are analyzed periodically and written down to their
net realizable value if they have become obsolete, have a cost basis in excess of its expected net realizable value or are in excess
of expected requirements. We analyze current and future product demand relative to the remaining product shelf life to identify
potential excess inventory. We build demand forecasts by considering factors such as, but not limited to, overall market potential,
market share, market acceptance and patient usage. The Company classifies inventory as current on the Consolidated Balance
Sheets when the Company expects inventory to be consumed for commercial use within the next twelve months.
23
Intangible Assets
Intangible assets with finite useful lives consist primarily of acquired product rights and acquired technology and are amortized
on a straight-line basis over their estimated useful lives (five to 20 years). The estimated useful lives associated with finite-lived
intangible assets are consistent with the estimated lives of the associated products and may be modified when circumstances
warrant. Such assets are reviewed for impairment when events or circumstances indicate that the carrying value of an asset may
not be recoverable. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result
from the use of an asset and its eventual disposition are less than its carrying amount. The amount of any impairment loss is
measured as the difference between the carrying amount and the fair value of the impaired asset.
Convertible Notes
We perform an assessment of all embedded features of a debt instrument to determine if (i) such features should be bifurcated and
separately accounted for, and (ii) if bifurcation requirements are met, whether such features should be classified and accounted for
as equity or debt instruments. If the embedded feature meets the requirements to be bifurcated and accounted for as a liability, the
fair value of the embedded feature is measured initially, included as a liability on the Consolidated Balance Sheets, and re-
measured to fair value at each reporting period. Any changes in fair value are recorded in the Consolidated Statement of
Operations. We monitor, on an ongoing basis, whether events or circumstances could give rise to a change in our classification of
embedded features.
We issued the December 2021 Notes with an option to settle conversions by paying or delivering, as applicable, cash, shares of
our common stock or a combination of cash and shares of our common stock, at our election. In accordance with accounting
guidance for convertible debt instruments that may be settled in cash or other assets on conversion, we separated the principal
balance between the fair value of the liability component and the common stock conversion feature using a market interest rate
for a similar nonconvertible instrument at the date of issuance.
The fair value of the liability component of the December 2021 Notes was estimated at $109.1 million at issuance. Therefore, the
difference between the face value of the December 2021 Notes at issuance and the estimated fair value of the liability component
was being amortized to interest expense over the term of the December 2021 Notes using the effective interest method.
On September 17, 2019, we exchanged $86.1 million aggregate principal of December 2021 Notes for an identical aggregate
original principal amount of December 2024 Notes, plus a cash payment of $70.00 for each $1,000 principal amount exchanged
(the “September Exchange Transaction”). We pay interest at 2.75% on the December 2024 Notes semiannually in arrears on June
1 and December 1 of each year, beginning December 1, 2019. The original principal of the December 2024 Notes will accrete at a
rate of 2.375% per year (“Accretion Interest”) commencing September 17, 2019 through the maturity of the December 2024
Notes. The accreted principal amount of the December 2024 Notes is payable in cash upon maturity. We issued the December
2024 Notes with an option to settle conversions by paying or delivering, as applicable, cash, shares of our common stock or a
combination of cash and shares of our common stock, at our election. In accordance with accounting guidance for convertible
debt instruments that may be settled in cash or other assets on conversion, we separated the principal balance between the fair
value of the liability component and the common stock conversion feature using a market interest rate for a similar nonconvertible
instrument at the date of issuance.
The September Exchange Transaction qualified as a debt extinguishment and we recognized a loss on exchange of the convertible
notes of $3.9 million, which is included in Non-operating income (expense), net in the Consolidated Statement of Operations for
the year ended December 31, 2019.
In accordance with the accounting guidance for an extinguishment of convertible debt instruments with a cash conversion feature,
we were required to allocate the fair value of the consideration transferred between the liability component and the equity
component. To calculate the fair value of the debt immediately prior to derecognition, the carrying value was recalculated in a
manner that reflected the estimated market interest rate for a similar nonconvertible instrument at the date of issuance. Using an
assumed borrowing rate of 7.05%, we calculated the fair value of the debt representing the amount allocated to the liability
component of the December 2024 Notes with the remainder of the consideration allocated to the equity conversion feature, to
reflect the reacquisition of the embedded conversion option. The conversion feature together with the fees allocated to the debt are
accounted for as a debt discount. As a result of the September Exchange Transaction, we recorded a total debt discount of $9.4
million, which included the common stock conversion feature of $8.1 million and the debt issuance fees of $1.3 million, charged
$5.5 million to Additional paid-in capital ($13.5 million charge to Additional paid-in capital representing the reduction to the 2021
equity component, partially offset by the $8.1 million allocated to equity for the 2024 notes) and recorded $1.2 million to deferred
24
tax liability. The net amount charged to Additional paid-in capital represents the difference between the consideration paid for the
September Exchange Transaction and the fair value of the convertible debt prior to the extinguishment.
In connection with the September Exchange Transaction, we entered into a capped call transaction with a counterparty on similar
terms and conditions as the capped call transaction entered into between the two parties when the December 2021 Notes were
issued. The aggregate cost of the capped call transaction was $4.5 million. We evaluated the capped call transaction under
authoritative accounting guidance and determined that it should be accounted for as a separate transaction and classified as a net
reduction to Additional paid-in capital within stockholders’ equity with no recurring fair value measurement recorded. Also with
the September Exchange Transaction, we and the counterparty unwound a portion of the capped call entered into when the
December 2021 Notes were issued as they were no longer scheduled to mature in 2021. The $0.9 million proceeds from the
unwind of the capped call, which reflected the value of the options outstanding at the time of the September Exchange
Transaction and the average share price of our common stock, were included as an increase to Additional paid-in capital within
stockholders’ equity.
On December 12, 2019, we initiated the repurchase of $119.3 million in aggregate principal amount of our December 2021 and
December 2024 convertible notes for $97.9 million in cash and 13.4 million shares of our common stock in privately negotiated
transactions (the “December Exchange Transaction”). The closing of the December Exchange Transaction occurred on December
17, 2019. We determined that the repurchase of the principal amount should be accounted for as a partial extinguishment of the
December 2021 Notes and December 2024 Notes and a loss on extinguishment of $4.5 million was recorded at closing of the
transaction. The loss on extinguishment included the de-recognition of a proportional share of the deferred issuance costs of $1.5
million. In connection with the December Exchange Transaction, we unwound a corresponding portion of the capped call related
to the convertible notes and repurchased 3.2 million shares of our common stock from the capped call counterparty. We paid the
capped call counterparty $4.3 million representing $11.0 million for the common stock repurchased, net of $6.7 million owed to
us for unwinding the capped call, which reflected the value of the options outstanding at the time of the December Exchange
Transaction. The common stock repurchased was reflected as a decrease to Retained earnings within stockholders’ equity. The
proceeds from the capped call were included as an increase to Additional paid-in capital within stockholders’ equity. In
furtherance of our monetization strategy, we expect to continue to repurchase or satisfy obligations relating to our convertible
notes.
The estimated fair value of the liability components at the date of issuance for the December 2021 Notes and December 2024
Notes were determined using valuation models and are complex and subject to judgment. Significant assumptions within the
valuation models included an implied credit spread, the expected volatility and dividend yield of our common stock and the risk-
free interest rate for notes with a similar term.
Product Revenue
General
In accordance with ASC 606, revenue is recognized from the sale of products and services when a customer obtains control of
such promised products and services. The amount of revenue recognized reflects the consideration to which we expect to be
entitled to receive in exchange for these products and services. A five-step model is utilized to achieve the core principle and
includes the following steps: (1) identify the customer contract; (2) identify the contract’s performance obligations; (3) determine
the transaction price; (4) allocate the transaction price to the performance obligations; and (5) recognize revenue when the
performance obligations are satisfied.
The following is a description of principal activities - separated by reportable segments - from which we generate our revenue.
Medical Devices
We principally generate revenue in our Medical Devices segment from the sale and lease of the LENSAR® Laser System, which
may include equipment, PIDs, procedure licenses, and training, installation, warranty and maintenance agreements.
For bundled packages, we account for individual products and services separately if they are distinct - i.e. if a product or service is
separately identifiable from other promises in the bundled package and if the customer can benefit from it on its own or with other
resources that are readily available to the customer. The LENSAR® Laser system, training and installation services are one
performance obligation. All other elements are separate performance obligations. PIDs, procedure licenses, warranty and
maintenance services are also sold on a stand-alone basis.
25
As we both sell and lease the LENSAR® Laser System, the consideration (including any discounts) is first allocated between lease
and non-lease components and then allocated between the separate products and services based on their stand-alone selling prices.
The stand-alone selling prices for the PIDs and procedure licenses are determined based on the prices at which we separately sell
the PIDs and procedure licenses. The LENSAR® Laser System and warranty stand-alone selling prices are determined using the
expected cost plus a margin approach.
For LENSAR® Laser System sales, we recognize revenue in product revenue when a customer takes possession of the system.
This usually occurs after the customer signs a contract, LENSAR installs the system, and LENSAR performs the requisite training
for use of the system. For LENSAR® Laser System leases, we recognized revenue in Product revenue over the length of the lease
in accordance with ASC Topic 840, Leases through December 31, 2018 and recognizes Product revenue in accordance with ASC
Topic 842, Leases, after January 1, 2019.
The LENSAR® Laser System requires both a consumable, a PID, and a procedure license to perform each procedure. We
recognize revenue for PIDs in product revenue when the customer takes possession of the PID. PIDs are sold by the case. We
recognize revenue for procedure licenses in product revenue when a customer purchases a procedure license from the web portal.
Typically, consideration for PIDs and procedure licenses is considered fixed consideration except for certain customer agreements
that provide for tiered volume discount pricing which is considered variable consideration.
We offer an extended warranty that provides additional services beyond the standard warranty. We recognize revenue from the
sale of extended warranties in product revenue over the warranty period. Customers have the option of renewing the warranty
period, which is considered a new and separate contract.
Income Generating Assets
Royalty Rights - At Fair Value
We account for our investments in royalty rights at fair value with changes in fair value presented in earnings. The fair value of
the investments in royalty rights is determined by using a discounted cash flow analysis related to the expected future cash flows
to be received. For each arrangement, we are entitled to royalty payments based on revenue generated by the net sales of the
product.
These assets are classified as Level 3 assets within the fair value hierarchy, as our valuation estimates utilize significant
unobservable inputs, including estimates. Critical estimates may include probability and timing of future sales of the related
products, product demand and market growth assumptions, inventory target levels, product approval and pricing assumptions.
Factors that could cause a change in estimates of future cash flows include a change in estimated market size, market share of the
products on which we receive royalties, a change in pricing strategy or reimbursement coverage, a delay in obtaining regulatory
approval, changes to forecast volume and pricing as a result of generic competition, a change in dosage of the product, and a
change in the number of treatments.
The changes in the estimated fair value from investments in royalty rights along with cash receipts in each reporting period are
presented together on our Consolidated Statements of Operations as a component of revenue under the caption, “Royalty rights -
change in fair value.”
Realized gains and losses on Royalty Rights are recognized as they are earned and when collection is reasonably assured. Royalty
Rights revenue is recognized over the respective contractual arrangement period. Transaction-related fees and costs are expensed
as incurred.
In the second quarter of 2019, due to the slower than expected adoption of Zalviso (the AcelRx Royalty Agreement product) since
its initial launch relative to our estimates and the increased variance noted between our forecast model and actual results in the
three months ended June 30, 2019, we utilized a third-party expert to reassess the market and expectations for the product. Based
on this analysis and the impact to the projected sales-based royalties and milestones, we wrote down the fair value of the royalty
asset by $60.0 million.
In the fourth quarter of 2019, management re-evaluated, with assistance of a third-party expert, the market share data, the gross-
to-net revenue adjustment assumptions, expected ex-U.S. launch dates and demand data for our Assertio royalty asset and wrote
down the fair value of the asset by $46.3 million.
26
Income Taxes
The provision for income taxes is determined using the asset and liability approach. Tax laws require items to be included in tax
filings at different times than the items are reflected in the financial statements. A current liability is recognized for the estimated
taxes payable for the current year. Deferred taxes represent the future tax consequences expected to occur when the reported
amounts of assets and liabilities are recovered or paid. Deferred taxes are adjusted for enacted changes in tax rates and tax laws.
Valuation allowances are recorded to reduce deferred tax assets when it is more likely than not that a tax benefit will not be
realized.
We recognize tax benefits from uncertain tax positions only if it is more likely than not that the tax position will be sustained on
examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the
Consolidated Financial Statements from such positions are then measured based on the largest benefit that has a greater than 50%
likelihood of being realized upon ultimate settlement. We adjust the level of the liability to reflect any subsequent changes in the
relevant facts surrounding the uncertain positions. Any interest and penalties on uncertain tax positions are included within the tax
provision.
The Tax Cuts and Jobs Act of 2017 (the “2017 Tax Act”) significantly changed the existing U.S. corporate income tax laws by,
among other things, lowering the corporate tax rate (from a top rate of 35% to a flat rate of 21%), implementing elements of a
territorial tax system, and imposing a one-time deemed repatriation transition tax on cumulative undistributed foreign earnings,
for which we have not previously paid U.S. taxes.
Business Combination
We apply ASC 805, Business combinations, pursuant to which the cost of an acquisition is measured as the aggregate of the fair
values at the date of exchange of the assets given, liabilities incurred, and equity instruments issued. The costs directly attributable
to the acquisition are expensed as incurred. Identifiable assets, liabilities and contingent liabilities acquired or assumed are
measured separately at their fair value as of the acquisition date, irrespective of the extent of any noncontrolling interests. The
excess of the (i) the total of cost of acquisition, fair value of the noncontrolling interests and acquisition date fair value of any
previously held equity interest in the acquiree over (ii) the fair value of the identifiable net assets of the acquiree is recorded as
goodwill. If the cost of acquisition is less than the fair value of the net assets of the subsidiary acquired, the difference is
recognized directly in the Consolidated Statements of Operations.
The determination and allocation of fair values to the identifiable assets acquired and liabilities assumed is based on various
assumptions and valuation methodologies requiring considerable management judgment. The most significant variables in these
valuations are discount rates, terminal values, the number of years on which to base the cash flow projections, as well as the
assumptions and estimates used to determine the cash inflows and outflows. Management determines discount rates to be used
based on the risk inherent in the related activity’s current business model and industry comparisons. Terminal values are based on
the expected life of products and forecasted life cycle and forecasted cash flows over that period. Although management believes
that the assumptions applied in the determination are reasonable based on information available at the date of acquisition, actual
results may differ from the forecasted amounts and the difference could be material.
Recently Issued Accounting Standards
See Note 2, Summary of Significant Accounting Policies, to the Consolidated Financial Statements of this Form 8-K for a
discussion of recently adopted accounting pronouncements and recently issued accounting pronouncements not yet adopted as of
December 31, 2019.
Recent Developments
Repurchase Program
From January 1, 2020 to March 10, 2020, the Company repurchased approximately 3.8 million shares of its common stock at a
weighted-average price of $3.42 per share for a total of $12.9 million and repurchased $3.2 million in aggregate principal amount
of December 2021 Convertible Notes and $10.5 million in aggregate principal amount of December 2024 Convertible Notes.
27
Amendment to CareView Modification Agreement
As further discussed in Note 8, Notes and Other Long-Term Receivables, to the Consolidated Financial Statement, in January
2020 we entered into an additional amendment with CareView whereby we agreed that the principal and interest payments would
be further deferred until April 30, 2020, which was conditioned upon CareView raising additional financing from third parties.
Plan of Liquidation
On February 7, 2020, our board of directors approved a plan of complete liquidation which triggered the change in control clause
in the Amended and Restated 2005 Equity Incentive Plan, accelerating the vesting of a significant portion of our outstanding
equity awards.
Events Subsequent to Original Issuance of Financial Statements
Repurchase Program
From March 11, 2020 to June 29, 2020, the Company repurchased approximately 8.6 million shares of its common stock at a
weighted-average price of $3.09 per share for a total of $26.5 million and repurchased $2.2 million in aggregate principal amount
of December 2021 Convertible Notes.
Evofem Share Distribution
On May 21, 2020 the Company announced that it had completed the distribution of all of the Company’s 13,333,334 shares of
common stock of Evofem Biosciences, Inc. to the Company shareholders, which represented approximately 26.7% of the
outstanding shares of Evofem common stock as of the close of business on May 15, 2020. Following the Distribution, PDL
continues to hold warrants to purchase up to 3,333,334 shares of Evofem common stock. The warrants are included in Other
Assets on the consolidated balance sheet and had a carrying value of $14.1 million at December 31, 2019. The distribution was
made in the form of a pro rata common stock dividend of 0.11591985 shares of Evofem common stock for every share of PDL
common stock. As of December 31, 2019, the Evofem common stock was valued at $82.3 million.
AcelRx
On May 22, 2020, the Company was notified by AcelRx that the product marketer of Zalviso, Grünenthal GmbH, has terminated
the license agreement with AcelRx. AcelRx is obligated to use commercially reasonable efforts to find a new license agreement
under the terms no less favorable than those in the license with Grünenthal. The Company believes that the asset is impaired and
estimates that unless and until the drug is relicensed the fair value will be substantially reduced. As of December 31, 2019, the
AcelRx fair value was $13.0 million and an impairment charge of approximately $13.0 million will be recorded in the three
months period ended June 30, 2020.
PDL Parental Financial Support Guarantee for LENSAR
On June 19, 2020, PDL issued a letter guaranteeing financial support to LENSAR up to $20 million through June 20, 2021.
COVID-19 Pandemic
In March 2020, the World Health Organization declared the outbreak of a novel coronavirus (“COVID-19”) pandemic. The
outbreak of the COVID-19 pandemic is significantly affecting the Company’s LENSAR business operations, as well as the U.S.
economy and financial markets. At this time, it doesn’t appear that our other segments have been significant impacted by the
pandemic. The full extent to which the COVID-19 outbreak will impact the Company’s business, results of operations, financial
condition and cash flows will depend on future developments that are highly uncertain and the estimates of the impact on the
Company’s business may change based on new information that may emerge concerning COVID-19 and the actions to contain
it or treat its impact and the economic impact on local, regional, national and international markets. While the Company cannot
provide a definitive timeline for the liquidation process, it has been targeting the end of 2020 for completing the monetization of
its key assets. However, the Company recognizes that the duration and extent of the public health issues related to the
COVID-19 pandemic make it possible, and perhaps probable, that the timing may be delayed.
Summary of 2019, 2018 and 2017 Financial Results
28
• Our net (loss) income for the years ended December 31, 2019, 2018 and 2017 was $(70.4) million, $(68.9) million and
$110.7 million, respectively and included net (loss) income from discontinued operations of $(2.5) million, ($37.1)
million and $97.3 million, respectively;
• At December 31, 2019, we had cash and cash equivalents of $169.0 million as compared with $365.7 million at
December 31, 2018, excluding cash and cash equivalents classified in assets held for sale of $24.5 million and $28.9
million, respectively;
• At December 31, 2019, we had $717.2 million in total assets as compared with $965.5 million at December 31, 2018,
including $351.5 million and $485.2 million as of December 31, 2019 and December 31, 2018, respectively, classified
as assets held for sale; and
• At December 31, 2019, we had $123.9 million in total liabilities including $120 thousand classified as liabilities held for
sale as compared with $235.7 million in total liabilities at December 31, 2018.
Revenues
A summary of our revenues for the years ended December 31, 2019, 2018 and 2017, is presented below:
(Dollars in thousands)
Revenues:
Product revenue, net (1) .............................
Royalty rights - change in fair value.........
Royalties from Queen et al. patents..........
Interest revenue.........................................
License and other......................................
Total revenues ......................................
___________________
N/M Not meaningful
2019
2018
Change from
Prior Year %
2017
Change from
Prior Year %
$
30,742
$
—
9
—
(45)
24,652
(30)
4,536
2,337
533
25 % $
15,091
(100)%
(100)%
N/M
(108)%
2,598
36,415
17,744
19,451
$
30,706
$
32,028
(4)% $
91,299
63 %
(101)%
(88)%
(87)%
(97)%
(65)%
(1) Our Product revenue, net consists entirely of revenue from our Medical Devices segment. We record Product revenue from our
Medical Devices segment from our LENSAR product sales which include LENSAR® Laser Systems, disposable consumables,
procedures, training, installation, warranty and maintenance services.
For the year ended December 31, 2019, compared to December 31, 2018
Our total revenues decreased by 4%, or $1.3 million, for the year ended December 31, 2019, when compared to the year ended
December 31, 2018. The decrease was primarily due to:
•
•
•
•
lower Queen et al. patent revenue in the current period
decreased interest revenue related to the CareView note receivable asset, and
lower license and other revenue, partially offset by
an increase in product revenue from sales of the LENSAR Laser Systems in our Medical Devices segment.
Revenue from our Medical Devices segment for the year ended December 31, 2019 was $30.7 million, an increase of 25%
compared to the year ended December 31, 2018. The increase is attributable to higher net revenues in both North America and the
rest of the world, with the majority of the increase outside of North America.
Revenue from our Income Generating Assets segment for the year ended December 31, 2019 was $(36.0) thousand, a decrease of
100%, or $7.4 million, when compared to the same period in 2018. The decrease was primarily due to:
•
•
•
decreasing royalties from the Queen et al. patents as the patents have expired,
the absence of interest revenue recognized from our CareView note receivable in 2019, and
lower license and other revenue.
29
For the year ended December 31, 2018, compared to December 31, 2017
Our total revenues decreased by 65%, or $59.3 million, for the year ended December 31, 2018, when compared to the year ended
December 31, 2017. The decrease was primarily due to:
•
•
•
•
•
lower 2018 sales of Tysabri manufactured prior to the patent expiry date reflected in Royalties from Queen et al. patents,
decreased interest revenues due to the sale of the kaléo note receivable asset in 2017,
a payment in 2017 from Merck recognized in License and other revenues as part of a settlement agreement to resolve the
patent infringement lawsuits related to Keytruda® (the “Merck settlement payment”), partially offset by
an increase in product revenues derived from sales of the LENSAR® Laser Systems attributable to a full year of revenue
recognized in 2018 as compared to a partial year in 2017, and
an increase in the fair value of the royalty rights not classified as held for sale in 2017 compared to a small decrease in
fair value in 2018.
Revenue from our Medical Devices segment for the year ended December 31, 2018 was $24.7 million, an increase of 63%
compared to the year ended December 31, 2017. The increase is attributable to a full year of revenue recognized in 2018 as
compared to a partial year in 2017.
Revenue from our Income Generating Assets segment for the year ended December 31, 2018 was $7.4 million, a decrease of
90%, or $68.8 million, when compared to the same period in 2017. The decrease was due to lower royalties from the Queen et al.
patents as sales of Tysabri manufactured prior to patent expiry, decreased interest revenue due to the sale of the kaléo note in 2017
and as a result of the 2017 Merck settlement payment.
The following table summarizes the percentage of our total revenues earned, which individually accounted for 10% or more of
our total revenues for one or more of the years ended December 31, 2019, 2018 and 2017:
Product Name
kaléo..................................................................................................................................
Merck................................................................................................................................
Biogen...............................................................................................................................
LENSAR...........................................................................................................................
Operating Expenses
Year Ended December 31,
2018
2017
2019
—%
—%
—%
100%
—%
—%
14%
77%
16%
21%
40%
17%
A summary of our operating expenses for the years ended December 31, 2019, 2018 and 2017 is presented below:
(Dollars in thousands)
Costs of product revenue (excluding intangible
amortization)............................................................
Amortization of intangible assets ............................
General and administrative......................................
Sales and marketing.................................................
Research and development ......................................
Asset impairment loss..............................................
Change in fair value of contingent consideration....
Total operating expenses.....................................
Percentage of total revenues .........................
___________________
N/M Not meaningful
2019
2018
Change from
Prior Year %
2017
Change from
Prior Year %
$ 17,276
$ 13,555
1,290
38,539
6,806
7,350
10,768
—
1,294
33,700
6,341
2,759
8,200
369
27 % $ 12,204
0 %
632
14 % 35,373
7 %
166 %
31 %
N/M
3,663
1,418
—
—
$ 82,029
$ 66,218
24 % $ 53,290
267%
207%
58%
11 %
105 %
(5)%
73 %
95 %
N/M
N/M
24 %
30
For the year ended December 31, 2019, compared to December 31, 2018
Total operating expenses increased by 24%, or $15.8 million for the year ended December 31, 2019, when compared to the year
ended December 31, 2018. The increase was primarily a result of:
•
•
•
•
•
•
an increase in research and development expenses in our Medical Devices segment primarily due to the exclusive
licensing of intellectual property from a third party for $3.5 million in cash for use in developing its next generation
technology,
higher cost of product revenue, due to increased sales in our Medical Devices segment, with the majority of the increase
related to increased system sales in 2019,
an increase in our general and administrative expenses, as detailed below,
an increase in our sales and marketing expenses in our Medical Devices segment, and
a $10.8 million impairment loss on the CareView note receivable recorded in 2019 compared to the $8.2 million
impairment loss on the CareView note receivable recorded in 2018, partially offset by
a decline in the expense recorded for the change in fair value of contingent consideration.
For the year ended December 31, 2018, compared to December 31, 2017
Total operating expenses increased by 24%, or $12.9 million for the year ended December 31, 2018, when compared to the year
ended December 31, 2017. The increase was primarily a result of:
•
•
•
•
•
•
an $8.2 million impairment loss on the CareView note,
higher cost of product revenue as sales increased in our Medical Devices segment, attributable to a full year of expenses
recognized in 2018 as compared to a partial year in 2017,
increased sales and marketing expenses in our Medical Devices segment,
increased research and development expenses in our Medical Devices segment, and
higher intangible asset amortization in our Medical Devices segment attributable to a full year amortization in 2018
compared to partial year amortization in 2017, partially offset by
lower general and administrative expenses, as detailed below.
General and administrative expenses for the years ended December 31, 2019, 2018 and 2017 by segment are summarized in the
tables below:
(in thousands)
Year Ended December 31, 2019
Income
Generating
Assets
Medical Devices
Total
$
4,109
1,883
1,260
966
—
—
759
403
$
1,713
6,984
$
Compensation......................................................................................
Salaries and wages (including taxes) ........................................................
$
Bonuses (including accruals).....................................................................
Equity .........................................................................................................
Asset management ..............................................................................
Business development.........................................................................
Accounting and tax services ...............................................................
Other professional services .................................................................
Other....................................................................................................
Total general and administrative ....................................................
31
$
16,656
6,277
3,643
6,736
2,246
1,282
4,400
1,970
5,001
20,765
8,160
4,903
7,702
2,246
1,282
5,159
2,373
6,714
31,555
$
38,539
(in thousands)
Year Ended December 31, 2018
Income
Generating
Assets
Medical Devices
Total
Compensation......................................................................................
Salaries and wages (including taxes) ........................................................
$
$
3,627
1,871
Bonuses (including accruals).....................................................................
Equity .........................................................................................................
Asset management ..............................................................................
Business development.........................................................................
Accounting and tax services ...............................................................
Other professional services .................................................................
Other....................................................................................................
Total general and administrative ....................................................
991
765
—
—
39
825
1,399
$
5,890
$
27,810
$
33,700
$
10,204
6,193
(203)
4,214
5,040
1,168
4,288
1,921
5,189
13,831
8,064
788
4,979
5,040
1,168
4,327
2,746
6,588
(in thousands)
Compensation...................................................................................
Salaries and wages (including taxes) .....................................................
$
Bonuses (including accruals)..................................................................
Equity ......................................................................................................
Asset management............................................................................
Business development ......................................................................
Accounting and tax services.............................................................
Other professional services ..............................................................
Other.................................................................................................
Total general and administrative..................................................
Non-operating Income (Expense), Net
Year Ended December 31, 2017
Income
Generating
Assets
Medical
Devices
Total
$
1,714
1,031
657
26
—
—
50
302
1,091
$
12,831
5,729
4,126
2,976
7,199
2,174
3,763
2,392
3,857
14,545
6,760
4,783
3,002
7,199
2,174
3,813
2,694
4,948
$
3,157
$
32,216
$
35,373
A summary of our non-operating expense, net, for the years ended December 31, 2019, 2018 and 2017, is presented below:
(Dollars in thousands)
Interest and other income, net.........................................
Interest expense ..............................................................
Equity affiliate - change in fair value .............................
Gain on sale of intangible assets.....................................
Gain on bargain purchase ...............................................
Gain on investments .......................................................
Loss on exchange and extinguishment of convertible
notes................................................................................
Total non-operating income (expense), net................
___________________
N/M Not meaningful
Change from
Prior Year %
2017
Change from
Prior Year %
266 %
(40)%
N/M
N/M
N/M
N/M
N/M
(42)%
2019
2018
$ 6,030
(11,404)
36,402
$ 6,065
(12,157)
—
3,476
—
—
—
—
764
(1)% $ 1,659
(6)% (20,221)
N/M
—
N/M
N/M
N/M
—
9,309
—
(8,430)
$ 26,074
—
$ (5,328)
N/M
—
(589)% $ (9,253)
32
For the year ended December 31, 2019, compared to December 31, 2018
Total non-operating income (expense), net, changed from expense of $5.3 million for the year ended December 31, 2018 to
income of $26.1 million for the year ended December 31, 2019, primarily due to:
•
•
•
•
•
an increase to the fair value of our investment in common stock and warrants of Evofem subsequent to our acquisition
earlier in 2019,
the decrease in interest expense due to the repurchase of some of our convertible notes, and
the gain recognized on the sale of our Direct Flow Medical, Inc. (“Direct Flow Medical”) intangible assets, partially
offset by
the losses on the exchange and extinguishment of a portion of our December 2021 Notes and December 2024 Notes, and
the absence of a realized gain on investments in 2019.
For the year ended December 31, 2018, compared to December 31, 2017
Total non-operating expenses, net, decreased by 42%, or $3.9 million for the year ended December 31, 2018, compared to the
year ended December 31, 2017. Non-operating expense, net, decreased due to:
•
•
•
•
the reduction in interest expense after the February 2018 Notes were repaid,
increased investment income as compared to the prior year, and
the gain on sale of investments in 2018, partially offset by
the bargain purchase gain recognized in 2017 with no such gain recognized in 2018.
Income Taxes
Income tax (benefit) expense from continuing operations for the years ended December 31, 2019, 2018 and 2017 was $(1.0)
million, $(6.8) million and $15.4 million, respectively, which resulted primarily from applying the federal statutory income tax
rate to (loss) income before income taxes from continuing operations. The tax rate of 4.4% in 2019 differs from the statutory tax
rate of 21% primarily as a result of increases in our uncertain tax positions valuation allowance. The tax rate of 17.0% in 2018
and 53.6% in 2017 differs from the statutory tax rate of 21% and 35%, respectively, primarily as a result of Subpart F and GILTI
income, and the increase in our valuation allowance in 2018.
During 2019, the amount of our unrecognized tax benefits increased by $3.4 million. The future impact of the unrecognized tax
benefits of $84.2 million, if recognized, is comprised of $27.9 million, which would affect the effective tax rate, and $56.3
million, which would result in adjustments to deferred tax assets and our valuation allowance.
Estimated interest and penalties associated with unrecognized tax benefits increased our income tax expense in the Consolidated
Statements of Operations by $1.6 million during the year ended December 31, 2019, $1.0 million during the year ended
December 31, 2018 and 2017. In general, our income tax returns are subject to examination by U.S. federal, state and local tax
authorities for tax years 2000 forward. Interest and penalties associated with unrecognized tax benefits accrued on the balance
sheet were $9.7 million, $8.0 million and $7.0 million as of December 31, 2019, 2018 and 2017, respectively. We are currently
under income tax examination by the State of California for tax years 2009 through 2015 and by the Internal Revenue Service for
the tax year 2016. The timing of the resolution of income tax examinations is highly uncertain, and the amounts ultimately paid, if
any, upon resolution of the issues raised by the taxing authorities may differ materially from the amounts accrued for each year.
We do not anticipate any material change to the amount of our unrecognized tax benefit over the next 12 months.
Assets held for sale and discontinued operations
The Pharmaceutical segment and the royalty right assets in the Income Generating Assets segment have been classified as held for
sale and reported as discontinued operations. The operating results from discontinued operations are presented separately in the
Company’s Consolidated statements of Operations as discontinued operations. Components of amounts reflected in (Loss) income
from discontinued operations are as follows:
33
(in thousands)
Revenues
Year Ended December 31,
2019
2018
2017
Product revenue, net........................................................................................
$
55,093
$
80,796
$
Royalty rights - change in fair value ...............................................................
Total revenues.......................................................................................................
Operating expenses
Cost of product revenue (excluding intangible asset amortization)................
Amortization of intangible assets....................................................................
General and administrative..............................................................................
Sales and marketing ........................................................................................
Research and development..............................................................................
Impairment of intangible assets.......................................................................
Change in fair value of anniversary payment and contingent consideration ..
Total operating expenses ......................................................................................
(Loss) income from discontinued operations before income taxes ......................
Income tax (benefit) expense from discontinued operations ..........................
(31,042)
24,051
36,343
5,016
7,059
1,675
(41)
22,490
—
72,542
(48,491)
(2,028)
85,287
166,083
34,906
14,536
11,720
10,800
196
152,330
(42,000)
182,488
(16,405)
19,689
(Loss) income from discontinued operations ...................................................
$
(46,463) $
(36,094) $
69,032
159,729
228,761
18,333
24,057
10,268
14,021
5,963
—
349
72,991
155,770
58,421
97,349
The royalty right assets in discontinued operations generated cash flows of $79.3 million and a net change in fair value of $(31.0)
million in the year ended December 31, 2019 compared to cash flows of $77.6 million and a net change in fair value of $85.3
million in the year ended December 31, 2018.
The following tables provides a summary of activity with respect to our royalty rights held for sale for the years ended
December 31, 2019 and 2018:
(in thousands)
Assertio..................................................................................................
VB..........................................................................................................
U-M .......................................................................................................
AcelRx...................................................................................................
KYBELLA.............................................................................................
Year Ended December 31, 2019
Change in
Fair Value
Cash Royalties
Total
$
$
72,225
$
966
5,664
307
110
79,272
$
(45,699) $
(518)
(5,197)
(57,428)
(1,472)
(110,314) $
26,526
448
467
(57,121)
(1,362)
(31,042)
(in thousands)
Assertio ...................................................................................................
VB...........................................................................................................
U-M.........................................................................................................
AcelRx ....................................................................................................
KYBELLA..............................................................................................
Year Ended December 31, 2018
Change in
Fair Value
Total
Cash Royalties
$
$
71,502
$
1,062
4,631
249
159
77,603
$
12,333
(272)
(1,174)
(2,514)
(690)
7,683
$
$
83,835
790
3,457
(2,265)
(531)
85,286
The adjustment to the fair value of the AcelRx royalty asset in the second quarter of 2019 was due to the slower than expected
adoption of Zalviso since its initial launch relative to our estimates and the increased variance noted between our forecast model
and actual results in the second quarter of 2019. We engaged a third-party expert in the second quarter of 2019 to reassess the
34
market and expectations for the product. Key findings from the third-party study included: the post-surgical PCA (Patient-
Controlled Analgesia) market being smaller than previously forecasted; the higher price of the product relative to alternative
therapies, the product not being used as a replacement for systemic opioids and the design of the delivery device, which is pre-
filled for up to three days of treatment, which limited its use for procedures with anticipated shorter recovery times.
The adjustment to the fair value of the Assertio royalty asset in the fourth quarter of 2019 was due to a decrease in the sales
forecast for the Assertio products. We engaged a third-party expert in the fourth quarter of 2019 to reassess the market and
expectations for the royalty asset. Key findings from the third-party study included: an anticipated decrease in the Glumetza net
sales forecast due to an accelerated shift in the channel mix resulting in a substantial decline in net selling prices, particularly in
the fourth quarter of 2019 and beyond, as previously announced by Bausch Health and the delayed launch dates of the extended
release products in the Assertio royalty asset portfolio outside of the United States.
Revenue from our Pharmaceutical segment for the year ended December 31, 2019 was $55.1 million, a decrease of 32% when
compared to the same period in 2018. The decrease in revenue from our Pharmaceutical segment reflects lower net revenues in
the United States and the rest of the world. The decrease in revenue from our Pharmaceutical segment in the United States for the
year ended December 31, 2019 reflects the introduction of our authorized generic form of Tekturna and a third-party generic form
of aliskiren during the year ended December 31, 2019. The decrease in revenue for the rest of the world is due to lower sales
volume of Rasilez in certain territories. All revenues from our Pharmaceutical segment were derived from sales of the Noden
Products. This increase in cost of goods sold, compared to the prior year is due to the higher percentage of authorized generic
sales in the current period and costs associated with the amended Novartis supply agreement. Sales and marketing expenses have
decreased substantially while the portion of general and administrative expenses attributable to the Pharmaceutical segment
decreased as well. Amortization of intangible assets expense decreased after Noden’s intangible assets were impaired at June 30,
2018, resulting in lower amortization.
The following table provides a summary of activity with respect to our sales allowances and accruals for the year ended
December 31, 2019:
(in thousands)
Balance as of December 31, 2018 ..................................
Allowances for current period sales ..........................
Allowances for prior period sales..............................
Credits/payments for current period sales .................
Credits/payments for prior period sales.....................
Balance as of December 31, 2019 ..................................
Discount and
Distribution
Fees
$
$
3,094
5,090
50
(3,813)
(3,076)
1,345
Government
Rebates and
Chargebacks
8,901
$
12,104
1,848
(8,843)
(10,393)
3,617
$
$
$
Assistance
and Other
Discounts
Product
Return
3,457
5,003
142
(4,186)
(3,411)
1,005
$
$
4,681
1,720
46
(276)
(2,295)
3,876
$
$
Total
20,133
23,917
2,086
(17,118)
(19,175)
9,843
We record revenue from our Pharmaceutical segment net of estimated product returns, pricing discounts, including rebates offered
pursuant to mandatory federal and state government programs, chargebacks, prompt pay discounts, distribution fees and co-pay
assistance for product sales each period.
Expenses decreased in our Pharmaceutical segment by 61%, or $110.4 million for the year ended December 31, 2019, when
compared to the year ended December 31, 2018. The decrease was primarily a result of:
•
•
•
•
a $22.5 million impairment of the Noden intangible asset in the current year compared to a $152.3 million impairment in
2018,
lower amortization expense for the Noden intangible assets in 2019 resulting from the impairment recorded in 2018 due
to the increased probability of a third-party generic form of aliskiren being launched in the United States,
lower sales and marketing expenses reflecting the cost savings from the change in our marketing strategy to a non-
personal promotion strategy for the Noden Products in anticipation of a launch of a third-party generic form of aliskiren.
This non-personal promotion strategy was subsequently discontinued upon the launch of our authorized generic form of
Tekturna in the first quarter of 2019, partially offset by
the favorable adjustment to the Noden acquisition related contingent consideration, which was first reduced in the second
quarter of 2018 prompted by the increased probability of a third-party generic form of aliskiren being launched in the
United States and subsequently eliminated in the fourth quarter of 2018 when the launch was imminent.
Expenses decreased in our Pharmaceutical segment by 152%, or $109.9 million for the year ended December 31, 2018, when
compared to the year ended December 31, 2017. The decrease was primarily a result of:
35
•
•
•
•
•
the impairment of intangible assets related to the Noden Products due to the increased probability of a third-party generic
version of aliskiren being launched in the United States,
an increase in cost of goods sold after the end of the Novartis profit transfer, partially offset by
the elimination of the contingent liability related to changes in the probabilities of a third-party generic version of
aliskiren being launched in the United States,
lower research and development expenses due to reduce clinical trial expenses related to the pediatric trial for Tekturna,
and
the decrease in the amortization of the related intangible assets as a result of the impairment.
Net (Loss) Income per Share
Net (loss) income per share for the years ended December 31, 2019, 2018 and 2017, is presented below:
Year Ended December 31,
2018
2017
2019
Net (loss) income per share - basic:
Continuing operations ................................................................................................... $
Discontinued operations................................................................................................ $
Net (loss) income attributable to PDL’s shareholders per basic share............................... $
(0.20) $
(0.39) $
(0.59) $
(0.22) $
(0.25) $
(0.47) $
Net (loss) income per share - diluted:
Continuing operations ................................................................................................... $
Discontinued operations................................................................................................ $
Net (loss) income attributable to PDL’s shareholders per diluted share ............................ $
(0.20) $
(0.39) $
(0.59) $
(0.22) $
(0.25) $
(0.47) $
0.09
0.62
0.71
0.09
0.62
0.71
Liquidity and Capital Resources
We have previously financed our operations primarily through royalty and other license-related revenues, public and private
placements of debt and equity securities, interest income on invested capital and cash generated from pharmaceutical and medical
device product sales. We plan to continue to finance our operations in the near term primarily through cash generated from our
existing cash, cash proceeds from our monetization efforts and medical device product sales.
In September 2019, we engaged financial and legal advisors and initiated a review of our strategy. In December 2019, we
disclosed that we planned to halt the execution of our growth strategy, cease making additional strategic transactions and
investments and pursue a formal process to unlock the value of our portfolio by monetizing our assets and ultimately returning net
proceeds to our stockholders. Over the subsequent months, our board of directors and management analyzed, together with its
outside financial and legal advisors, how to best capture value pursuant to its monetization strategy and best return the significant
intrinsic value of the high-quality assets in its portfolio to the stockholders. In February of 2020, the board of directors approved a
plan of complete liquidation of our assets and passed a resolution to seek stockholder approval to dissolve the Company under
Delaware law at its next annual meeting of the stockholders. In the event that the Board concludes that the whole company sale
process is unlikely to maximize the value that can be returned to the stockholders from our monetization process, we would, if
approved by the stockholders, file a certificate of dissolution in Delaware and proceed to wind-down and dissolve the Company in
accordance with Delaware law. Pursuant to its monetization strategy, we are exploring a variety of potential transactions,
including a whole company sale, divestiture of assets, spin-offs of operating entities, merger opportunities or a combination
thereof. In addition, we have analyzed, and continue to analyze, the optimal mechanisms for returning value to stockholders in a
tax-efficient manner, including via share repurchases, cash dividends and other distributions of assets. We have not set a definitive
timeline and intend to pursue monetization in a disciplined and cost-effective manner to maximize returns to stockholders. We
recognize, however, that accelerating the timeline, while continuing to optimize asset value, could increase returns to stockholders
due to reduced general and administrative expenses as well as provide faster returns to stockholders. While we cannot provide a
definitive timeline for the monetization and wind-down process, we are targeting the end of 2020 for completing the monetization
of its key assets.
36
As a result of this monetization strategy, we expect to generate additional cash from the sale of one or more of the assets in our
portfolio with the intention of managing the successful wind down of our business and distributing the remaining net proceeds to
our stockholders.
Our future capital requirements are difficult to forecast and will depend upon many factors, including the type of distributions we
make, the amount of net cash proceeds we receive, after transaction costs, and the time it takes to monetize our assets. Our future
capital requirements will also depend on the amount of common stock and convertible notes we repurchase under our repurchase
program, both of which we expect to pursue as part of our monetization strategy.
The general cash needs of our Medical Devices, Strategic Positions and Income Generating Assets segments can vary
significantly.
•
In our Medical Devices segment, the primary factor determining cash needs is the funding of operations, which we
expect to continue to expand as the business grows, and enhancing our product offerings through the research and
development of our next generation device which will integrate a femtosecond laser and a phacoemulsification system in
a single, compact workstation.
• The cash needs of our Income Generating Assets segment tend to be driven by legal and professional service fees
required for operating a publicly traded company, as well as the funding of potential repurchases of our common stock
and convertible notes.
• The current cash needs for our Strategic Positions segment are insignificant.
On December 9, 2019, we announced that our board of directors authorized the repurchase of issued and outstanding shares of our
common stock and convertible notes up to an aggregate value of $200.0 million pursuant to a share repurchase program. On
December 16, 2019, we announced that our board of directors approved a $75.0 million increase to this repurchase program.
Repurchases under the new repurchase program will be made from time to time in the open market or in privately negotiated
transactions and funded from our working capital. The amount and timing of such repurchases will depend upon the price and
availability of shares or convertible notes, general market conditions and the availability of cash. Common stock and convertible
note repurchases may also be made under a trading plan under Rule 10b5-1, which would permit shares and convertible notes to
be repurchased when we might otherwise be precluded from doing so because of self-imposed trading blackout periods or other
regulatory restrictions. All shares of common stock repurchased under our repurchase program are expected to be retired and
restored to authorized but unissued shares of common stock. All convertible notes repurchased under the program will be retired.
As of December 31, 2019, we had repurchased $44.8 million in aggregate principal amount of December 2021 Notes and $74.5
million in aggregate principal amount of December 2024 Notes under the board authorized program for aggregate consideration
consisting of a cash payment of $97.9 million and the issuance of 13.4 million shares of our common stock. Pursuant to the
convertible note repurchase transactions and the unwinding of a proportional amount of the capped call transaction entered into
for the notes, we also repurchased 3.2 million shares of our common stock under this program directly from our capped call
counterparty. This repurchase program may be suspended at any time without notice.
Our debt service obligations consists of interest payments and repayment of our December 2021 Notes and December 2024
Notes. We have and may continue to repurchase the remaining outstanding convertible notes, which could adversely affect the
amount or timing of any distributions to our stockholders. We expect to finance such repurchases with cash on hand.
We had cash and cash equivalents in the aggregate of $169.0 million and $365.7 million at December 31, 2019 and 2018,
respectively, representing a decrease of $196.7 million. The decrease was primarily attributable to the repurchase of the December
2021 Notes and December 2024 Notes for $97.9 million, the repurchase of stock of $86.9 million, the investment in Evofem of
$60.0 million and cash used in operating activities of $31.2 million, partially offset by cash received from royalties of $79.3
million. Our royalty assets are classified as held for sale as of December 31, 2019. Cash generated by the royalty assets is used for
general corporate purposes and is not segregated from cash from operations.
In our Pharmaceutical segment, which is held for sale as of December 31, 2019, cash needs tend to be driven primarily by
material purchases. We have cash and cash equivalents at our Pharmaceutical segment of $24.5 million and $28.9 million as of
December 31, 2019 and 2018, respectively, which we believe is sufficient to fund operations and meet our contractual inventory
commitment for the foreseeable future.
We believe that cash on hand and cash generated from future revenues and from asset sales, net of operating expenses, debt
service and income taxes, will be sufficient to fund our operations until all net proceeds are distributed to our stockholders. Our
continued success is dependent on our ability to execute on our planned strategy to monetize our assets, in order to return capital
to our stockholders and service our remaining debt.
37
Off-Balance Sheet Arrangements
As of December 31, 2019, we did not have any off-balance sheet arrangements, as defined under SEC Regulation S-K Item
303(a)(4)(ii).
Contractual Obligations
The following table summarizes our contractual obligations and commercial commitments as of December 31, 2019:
(in thousands)
Operating leases 1 .............................................
Convertible notes 2 ...........................................
Inventory 3 ........................................................
Total contractual obligations .......................
Less than 1
year
1-3 years
3-5 years
Thereafter
Total
$
$
$
958
843
49,419
776
$
— $
— $
20,329
22,639
13,636
—
—
—
1,734
34,808
72,058
51,220
$
43,744
$
13,636
$
— $
108,600
Payments Due by Period
_____________________________
1 Amounts represent the lease for our headquarters in Incline Village, Nevada, the lease for the LENSAR office and
manufacturing facility in Orlando, Florida and operating leases for office equipment. The above amounts also include
future operating lease payments of $0.3 million for the Noden Pharma DAC office in Dublin, Ireland, which is
classified as held for sale as of December 31, 2019.
2 Amounts represent principal and cash interest payments due on the December 2021 Notes and the December 2024
Notes and accretion interest on the December 2024 Notes.
3 Consist of minimum purchase obligation for inventory components for LENSAR and for API and bulk tablets under the
Novartis supply agreement for our Noden subsidiary classified as held for sale as of December 31, 2019, as discussed in
“Purchase Obligations” below.
Our liability for uncertain tax positions was $37.6 million as of December 31, 2019, all of which has been excluded from the table
above due to the uncertainty in the timing of the settlement of these positions.
Purchase Obligations
Noden DAC and Novartis entered into a supply agreement pursuant to which Novartis will manufacture and supply to Noden
DAC a bulk tableted form of the Noden Products and API. In May 2019, Noden DAC and Novartis entered into an amended
supply agreement pursuant to which Novartis will supply to Noden DAC a bulk tableted form of the Noden Products through
2020 and API through June 2021. The supply agreement may be terminated by either party for material breach that remains
uncured for a specified time period. Under the terms of the amended supply agreement, Noden DAC is committed to purchase
certain quantities of bulk product and API that would amount to approximately $61.7 million through June 2021, of which $39.8
million is committed over the next twelve months, which are guaranteed by us. While the supply agreement provides that the
parties will agree to reasonable accommodations with respect to changes in firm orders, we expect that Noden DAC will meet the
requirements of the supply agreement, unless otherwise negotiated.
LENSAR entered into various supply agreements for the manufacture and supply of certain components. The supply agreements
commit LENSAR to a minimum purchase obligation of approximately $10.4 million over the next twenty-four months of which
$9.6 million is due in the next 12 months, a portion of which are guaranteed by us. LENSAR expects to meet these requirements.
Guarantees
Redwood City Lease Guarantee
In connection with the spin-off of Facet in December 2008, we entered into amendments to the leases for our former facilities in
Redwood City, California, under which Facet was added as a co-tenant and a Co-Tenancy Agreement, under which Facet agreed
to indemnify us for all matters related to the leases attributable to the period after the spin-off date. In April 2010, Abbott
Laboratories acquired Facet and later renamed the entity AbbVie Biotherapeutics, Inc. (“AbbVie”). If AbbVie were to default
under its lease obligations, we could be held liable by the landlord as a co-tenant, and, thus, we have in substance guaranteed the
payments under the lease agreements for the Redwood City facilities. As of December 31, 2019, the total lease payments for the
38
duration of the guarantee, which runs through December 2021, are approximately $22.6 million. For additional information
regarding our lease guarantee, see Note 16, Commitments and Contingencies.
Escrow Receivable
On September 21, 2017, we entered into an agreement (the “kaléo Note Sale Agreement”) with MAM-Kangaroo Lender, LLC, a
Delaware limited liability company (the “kaléo Purchaser”), pursuant to which we sold our entire interest in the notes issued by
Accel 300, LLC (“Accel 300”) pursuant to that certain Indenture, dated as of April 1, 2014, by and between Accel 300 and U.S.
Bank National Association, as the current trustee of the notes described therein (the “kaléo Note”).
Pursuant to the kaléo Note Sale Agreement, the kaléo Purchaser paid to us an amount equal to 100% of the then outstanding
principal, a premium of 1% of such amount and accrued interest under the kaléo Notes, for an aggregate cash purchase price of
$141.7 million.
The aggregate purchase price of $1.4 million was deposited into an escrow account as a potential payment against certain
contingencies for 18 months. The escrow period ended on March 20, 2019 and the escrow agent released the entire $1.4 million to
us.
39
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of PDL BioPharma, Inc.
Opinions on the Financial Statements and Internal Control over Financial Reporting
We have audited the accompanying consolidated balance sheets of PDL BioPharma, Inc. and its subsidiaries (the “Company”) as
of December 31, 2019 and 2018, and the related consolidated statements of operations, of comprehensive (loss) income, of
stockholders’ equity and of cash flows for each of the three years in the period ended December 31, 2019, including the related
notes (collectively referred to as the “consolidated financial statements”). We also have audited the Company's internal control
over financial reporting as of December 31, 2019, based on criteria established in Internal Control - Integrated Framework (2013)
issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position
of the Company as of December 31, 2019 and 2018, and the results of its operations and its cash flows for each of the three years
in the period ended December 31, 2019 in conformity with accounting principles generally accepted in the United States of
America. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting
as of December 31, 2019, based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO.
Basis for Opinions
The Company's management is responsible for these consolidated financial statements, for maintaining effective internal control
over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in
Management’s Report on Internal Control over Financial Reporting (not presented herein) appearing under Item 9A of the
Company’s 2019 Annual Report on Form 10-K. Our responsibility is to express opinions on the Company’s consolidated financial
statements and on the Company's internal control over financial reporting based on our audits. We are a public accounting firm
registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent
with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the
Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the
audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement,
whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material
respects.
Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of
the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such
procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial
statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as
well as evaluating the overall presentation of the consolidated financial statements. Our audit of internal control over financial
reporting 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 audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our
audits provide a reasonable basis for our opinions.
Subsequent Event
As discussed in Note 27 to the consolidated financial statements, on February 7, 2020, the Company’s board of directors approved
a plan of liquidation.
Definition and Limitations of Internal Control over Financial Reporting
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
(i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of
40
the assets of the company; (ii) 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 (iii) 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.
/s/ PricewaterhouseCoopers LLP
San Francisco, California
March 11, 2020, except with respect to our opinion on the consolidated financial statements insofar as it relates to the effects of
discontinued operations discussed in Note 3, as to which the date is June 29, 2020
We have served as the Company’s auditor since 2014.
41
PDL BIOPHARMA, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
December 31,
2019
2018
Assets
Current assets:
Cash and cash equivalents ............................................................................................................................................ $
168,982
$
365,680
Accounts receivable, net ...............................................................................................................................................
Notes receivable............................................................................................................................................................
Inventory .......................................................................................................................................................................
Assets held for sale (Note 3).........................................................................................................................................
Prepaid and other current assets....................................................................................................................................
Total current assets..................................................................................................................................................
Property and equipment, net ...............................................................................................................................................
Investment in equity affiliate ..............................................................................................................................................
Notes and other receivables, long-term ..............................................................................................................................
Long-term deferred tax assets.............................................................................................................................................
Intangible assets, net ...........................................................................................................................................................
Long-term assets held for sale (Note 3)..............................................................................................................................
Other assets .........................................................................................................................................................................
6,559
52,583
8,061
70,366
7,344
313,895
2,560
82,267
827
—
13,186
281,087
23,384
Total assets............................................................................................................................................................. $
717,206
$
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable .......................................................................................................................................................... $
2,675
$
Accrued liabilities .........................................................................................................................................................
Liabilities held for sale (Note 3) ...................................................................................................................................
Total current liabilities ............................................................................................................................................
Convertible notes payable...................................................................................................................................................
Liabilities held for sale, long-term (Note 3) .......................................................................................................................
Other long-term liabilities...................................................................................................................................................
Total liabilities ........................................................................................................................................................
11,923
31,095
45,693
27,250
120
50,865
123,928
4,774
63,042
4,062
65,143
14,516
517,217
3,705
—
771
1,539
13,700
420,046
8,530
965,508
2,529
9,240
40,700
52,469
124,644
—
58,616
235,729
Commitments and contingencies (Note 16)
Stockholders’ equity:
Preferred stock, par value $0.01 per share, 10,000 shares authorized; no shares issued and outstanding ...................
—
—
Common stock, par value $0.01 per share, 350,000 shares authorized; 124,303 and 136,513 shares issued and
outstanding at December 31, 2019 and 2018, respectively ..........................................................................................
Additional paid-in capital .............................................................................................................................................
Treasury stock, at cost (zero and 750 shares held) .......................................................................................................
Retained earnings..........................................................................................................................................................
Total PDL’s stockholders’ equity ............................................................................................................................
Noncontrolling interests....................................................................................................................................
Total stockholders’ equity .......................................................................................................................................
1,243
(78,875)
—
670,832
593,200
78
593,278
Total liabilities and stockholders’ equity ............................................................................................................ $
717,206
$
1,365
(98,030)
(2,103)
828,547
729,779
—
729,779
965,508
See accompanying notes.
42
PDL BIOPHARMA, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
Year Ended December 31,
2019
2018
2017
Revenues
Product revenue, net........................................................................................................................ $
30,742
$
24,652
$
Royalty rights - change in fair value...............................................................................................
Royalties from Queen et al. patents ................................................................................................
Interest revenue...............................................................................................................................
License and other ............................................................................................................................
Total revenues ...........................................................................................................................
Operating expenses
Cost of product revenue (excluding intangible asset amortization and impairment) .....................
Amortization of intangible assets....................................................................................................
General and administrative .............................................................................................................
Sales and marketing ........................................................................................................................
Research and development .............................................................................................................
Asset impairment loss .....................................................................................................................
Change in fair value of anniversary payment and contingent consideration ..................................
Total operating expenses...........................................................................................................
Operating (loss) income from continuing operations ......................................................................
Non-operating income (expense), net
Interest and other income, net.........................................................................................................
Interest expense...............................................................................................................................
Equity affiliate - change in fair value .............................................................................................
Gain on sale of intangible assets.....................................................................................................
Gain on bargain purchase................................................................................................................
Gain on investments........................................................................................................................
Loss on exchange and extinguishment of convertible notes...........................................................
Total non-operating income (expense), net...............................................................................
(Loss) income before income taxes from continuing operations.....................................................
Income tax (benefit) expense from continuing operations .............................................................
Net (loss) income from continuing operations......................................................................................
(Loss) income from discontinued operations before income taxes ...................................................
Income tax (benefit) expense of discontinued operations..................................................................
(Loss) income from discontinued operations........................................................................................
Net (loss) income .................................................................................................................................
Less: Net (loss) income attributable to noncontrolling interests ...................................................
Net (loss) income attributable to PDL’s stockholders...................................................................... $
—
9
—
(45)
30,706
17,276
1,290
38,539
6,806
7,350
10,768
—
82,029
(51,323)
6,030
(11,404)
36,402
3,476
—
—
(8,430)
26,074
(25,249)
(1,021)
(24,228)
(48,491)
(2,028)
(46,463)
(70,691)
(280)
(30)
4,536
2,337
533
32,028
13,555
1,294
33,700
6,341
2,759
8,200
369
66,218
(34,190)
6,065
(12,157)
—
—
—
764
—
(5,328)
(39,518)
(6,753)
(32,765)
(16,405)
19,689
(36,094)
(68,859)
—
15,091
2,598
36,415
17,744
19,451
91,299
12,204
632
35,373
3,663
1,418
—
—
53,290
38,009
1,659
(20,221)
—
—
9,309
—
—
(9,253)
28,756
15,404
13,352
155,770
58,421
97,349
110,701
(47)
(70,411) $
(68,859) $
110,748
Net (loss) income per share - basic:
Continuing operations..................................................................................................................... $
(0.20) $
(0.22) $
Discontinued operations..................................................................................................................
(0.39)
(0.25)
Net (loss) income attributable to PDL’s shareholders per basic share.................................................. $
Net (loss) income per share - diluted:
(0.59) $
(0.47) $
Continuing operations..................................................................................................................... $
(0.20) $
(0.22) $
Discontinued operations..................................................................................................................
(0.39)
(0.25)
Net (loss) income attributable to PDL’s shareholders per diluted share ............................................... $
Weighted-average shares outstanding
(0.59) $
(0.47) $
0.09
0.62
0.71
0.09
0.62
0.71
Basic................................................................................................................................................
Diluted.............................................................................................................................................
118,631
118,631
145,669
145,669
155,394
156,257
See accompanying notes.
43
PDL BIOPHARMA, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME
(In thousands)
Year Ended December 31,
2019
2018
2017
Net (loss) income ............................................................................................................
$
(70,691) $
(68,859) $ 110,701
Other comprehensive (loss) income, net of tax
Change in unrealized gains on investments in available-for-sale securities:
Change in fair value of investments in available-for-sale securities, net of tax .......
Adjustment for net (gains) losses realized and included in net (loss) income, net
of tax .........................................................................................................................
Total change in unrealized gains (losses) on investments in available-for-sale
securities, net of tax(a) ..........................................................................................
Comprehensive (loss) income........................................................................................
Less: Comprehensive (loss) income attributable to noncontrolling interests...........
Comprehensive (loss) income attributable to PDL’s stockholders ............................
—
—
(578)
1,181
(603)
—
—
(70,691)
(280)
(70,411) $
$
(1,181)
(70,040)
—
(47)
(70,040) $ 111,929
1,181
111,882
___________________________________
(a) Net of tax of ($314) and $314 for the years ended December 31, 2018 and 2017, respectively.
See accompanying notes.
44
PDL BIOPHARMA, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In thousands, except share amounts)
Balance at December 31, 2016 .................................
165,538,447
$ 1,655
$
— $ (107,628) $ 857,116
$
— $
4,280
$
755,423
PDL’s Stockholders Equity
Common Stock
Shares
Amount
Treasury
Stock
Additional
Paid-In
Capital
Retained
Earnings
Accumulated
Other
Comprehensive
Income (Loss)
Non-
controlling
Interest
Total
Stockholders’
Equity
Issuance of common stock, net of forfeitures .............
Stock-based compensation expense............................
1,582,698
—
16
—
Repurchase and retirement of common stock.............
Acquisition of Noden common stock .........................
Cumulative effect from change in accounting
principles.....................................................................
Comprehensive income:
Net income ............................................................
Change in unrealized gains and losses on
investments in available-for-sale securities, net
of tax .....................................................................
Total comprehensive income ................................
(13,346,389)
(133)
—
—
—
—
—
—
—
—
—
—
Balance at December 31, 2017 .................................
153,774,756
1,538
Issuance of common stock, net of forfeitures .............
Stock-based compensation expense............................
(601,668)
—
(6)
—
—
—
—
—
—
—
—
—
—
—
—
Repurchase and retirement of common stock.............
(16,660,566)
(167)
(2,103)
Comprehensive loss:
Net loss..................................................................
Change in unrealized gains and losses on
investments in available-for-sale securities, net
of tax .....................................................................
Total comprehensive loss......................................
—
—
—
—
—
—
—
—
—
(16)
3,138
—
—
—
(29,867)
2,063
—
—
7,617
—
110,748
—
—
—
—
(102,443)
945,614
6
4,407
—
—
—
—
58
—
(48,266)
(68,859)
—
—
Balance at December 31, 2018 .................................
136,512,522
1,365
(2,103)
(98,030)
828,547
Issuance of common stock, net of forfeitures .............
729,191
Stock-based compensation expense............................
—
7
—
—
—
(7)
6,907
8
—
Repurchase and retirement of common stock.............
(26,321,293)
(263)
2,103
—
(87,312)
Transfer of subsidiary shares to non-controlling
interest.........................................................................
Exchange of convertible notes ....................................
—
—
Issuance of common stock in connection with
repurchase of convertible notes ..................................
13,382,196
Capped call transactions .............................................
Comprehensive loss:
Net loss..................................................................
Total comprehensive loss......................................
—
—
—
—
—
134
—
—
—
—
—
—
—
—
—
426
(36,963)
45,767
3,025
—
—
—
—
—
—
(70,411)
—
—
—
—
—
—
—
1,181
—
1,181
—
—
—
—
(1,181)
—
—
—
—
—
—
—
—
—
—
—
Balance at December 31, 2019 .................................
124,302,616
$ 1,243
$
— $ (78,875) $ 670,832
$
— $
See accompanying notes.
—
—
—
(4,233)
—
3,138
(30,000)
(2,170)
—
7,617
(47)
110,701
—
—
—
—
—
—
—
—
—
—
—
—
—
358
—
—
—
(280)
—
78
1,181
111,882
845,890
58
4,407
(50,536)
(68,859)
(1,181)
(70,040)
729,779
8
6,907
(85,472)
784
(36,963)
45,901
3,025
(70,691)
(70,691)
$
593,278
45
PDL BIOPHARMA, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Cash flows from operating activities
Net (loss) income............................................................................................................................................. $
Less: (Loss) income from discontinued operations .....................................................................................
Net (loss) income from continuing operations .......................................................................................................
$
(70,691)
(46,463)
(24,228)
$
(68,859)
(36,094)
(32,765)
110,701
97,349
13,352
2019
Year Ended December 31,
2018
2017
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities:
Amortization of convertible notes conversion options and debt issuance costs.......................................
Accreted interest on convertible note principal ........................................................................................
Amortization of intangible assets .............................................................................................................
Amortization of right-of-use assets ..........................................................................................................
Asset impairment loss...............................................................................................................................
Change in fair value of royalty rights - at fair value.................................................................................
Change in fair value of equity affiliate .....................................................................................................
Change in fair value of derivative assets ..................................................................................................
Change in fair value of anniversary payment and contingent consideration............................................
Other amortization, depreciation and accretion of embedded derivative .................................................
Loss on exchange and extinguishment of convertible notes ....................................................................
Gain on sale of intangible assets...............................................................................................................
Gain on sale of available-for-sale securities .............................................................................................
Loss on disposal of property and equipment ............................................................................................
Escrow receivable .....................................................................................................................................
Bargain purchase gain...............................................................................................................................
Stock-based compensation expense..........................................................................................................
Deferred income taxes ..............................................................................................................................
Changes in assets and liabilities:
Accounts receivable..................................................................................................................................
Prepaid and other current assets ...............................................................................................................
Accrued interest on notes receivable ........................................................................................................
Inventory...................................................................................................................................................
Other assets ...............................................................................................................................................
Accounts payable......................................................................................................................................
Accrued liabilities .....................................................................................................................................
Accrued income taxes...............................................................................................................................
Other long-term liabilities.........................................................................................................................
Net cash (used in) provided by operating activities - continuing operations ..................................................
Net cash (used in) provided by operating activities - discontinued operations ...............................................
Cash flows from investing activities
Purchases of investments.................................................................................................................................
Investment in equity affiliate ...........................................................................................................................
Maturities of investments-other.......................................................................................................................
Payment of contingent consideration ..............................................................................................................
Proceeds from sales of available-for-sale securities........................................................................................
Purchase of royalty rights - at fair value..........................................................................................................
Proceeds from royalty rights - at fair value .....................................................................................................
Purchase of intangible assets ...........................................................................................................................
Sale of royalty rights - at fair value .................................................................................................................
Proceeds from the sale of intangible assets .....................................................................................................
Repayment of notes receivable........................................................................................................................
Proceeds from sales of assets held for sale......................................................................................................
Purchase of property and equipment ...............................................................................................................
Net cash provided by investing activities - continuing operations..................................................................
Net cash provided by investing activities - discontinued operations...............................................................
Cash flows from financing activities
Repurchase of convertible notes......................................................................................................................
Repayment of convertible notes ......................................................................................................................
Payment to exchange convertible notes...........................................................................................................
Capped call transactions ..................................................................................................................................
Payment of contingent consideration ..............................................................................................................
Cash paid for purchase of noncontrolling interest...........................................................................................
Repurchase of Company common stock .........................................................................................................
Cash dividends paid.........................................................................................................................................
Net settlement of stock-based compensation awards ......................................................................................
Net cash used in financing activities - continuing operations .........................................................................
Net cash used in financing activities - discontinued operations......................................................................
Net (decrease) increase in cash and cash equivalents ............................................................................................
Cash and cash equivalents at beginning of the year ...............................................................................................
Cash and cash equivalents at end the year..............................................................................................................
Less: Cash and cash equivalents of discontinued operations .................................................................................
Cash and cash equivalents of continuing operations at end of period.................................................................... $
See accompanying notes
46
7,237
79
1,290
729
10,768
—
(31,641)
(4,715)
—
2,691
8,430
(3,476)
—
—
—
—
6,834
(11,303)
(1,686)
2,764
—
(4,744)
(165)
109
4,845
—
4,967
(31,215)
(1,229)
—
(60,000)
—
—
—
—
—
(1,700)
—
5,000
—
—
(763)
(57,463)
79,273
7,609
—
1,294
—
8,200
31
—
(33)
369
3,149
—
—
(764)
66
—
—
4,337
11,597
234
(1,629)
—
(889)
(2,142)
796
(5,380)
(28)
(462)
(6,410)
(7,015)
—
—
—
(858)
4,116
—
366
—
—
—
—
—
(1,117)
2,507
54,197
(97,889)
—
(7,451)
3,025
(1,071)
—
(86,898)
(9)
(143)
(190,436)
(69)
(201,139)
394,590
193,451
24,469
168,982
$
—
(126,447)
—
—
—
—
(49,109)
(48)
(232)
(175,836)
(119)
(132,676)
527,266
394,590
28,910
365,680
$
11,038
—
632
—
—
(2,598)
—
49
—
2,094
—
—
(108)
—
(1,400)
(9,309)
2,957
42,407
2,877
(9,451)
1,475
4,269
(1,662)
(2,330)
3,258
(2,426)
770
55,894
(15,270)
(23,213)
—
75,000
—
39,956
—
4,301
—
108,169
—
144,829
8,190
(229)
357,003
101,884
—
—
—
—
—
(2,170)
(30,000)
(222)
—
(32,392)
(87,007)
380,112
147,154
527,266
39,752
487,514
PDL BIOPHARMA, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS, continued
(In thousands)
Year Ended December 31,
2019
2018
2017
Supplemental cash flow information for continuing and discontinued operations
Cash (refunded) paid for income taxes....................................................................................... $
Cash paid for interest.................................................................................................................. $
(2,689) $
4,265
$
3,805
6,654
$
$
Supplemental schedule of non-cash investing and financing activities for continuing and
discontinued operations
Convertible notes due December 2021 exchanged for convertible notes due December 2024 . $
Common stock used to settle convertible notes payable............................................................ $
Assets held for sale reclassified from other assets to intangible assets...................................... $
Asset held for sale reclassified from notes receivable to other assets........................................ $
Extinguishment of notes receivable ........................................................................................... $
86,053
45,901
$
$
— $
— $
— $
— $
— $
1,811
$
— $
— $
43,366
9,286
—
—
—
10,000
43,909
See accompanying notes
47
PDL BIOPHARMA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2019
1. Organization and Business
Throughout our history, the Company’s mission has been to improve the lives of patients by aiding in the successful development
of innovative therapeutics and healthcare technologies. PDL BioPharma was founded in 1986 as Protein Design Labs, Inc. when it
pioneered the humanization of monoclonal antibodies, enabling the discovery of a new generation of targeted treatments that have
had a profound impact on patients living with different cancers as well as a variety of other debilitating diseases. In 2006, the
Company changed its name to PDL BioPharma, Inc.
Historically, the Company generated a substantial portion of its revenues through the license agreements related to patents
covering the humanization of antibodies, which it refers to as the Queen et al. patents. In 2012, the Company began providing
alternative sources of capital through royalty monetizations and debt facilities, and, in 2016, the Company began acquiring
commercial-stage products and launching specialized companies dedicated to the commercialization of these products. In 2019,
and as a further evolution of the Company’s strategy, it began to enter into strategic transactions involving innovative late clinical-
stage or early commercial-stage therapeutics. Consistent with this strategy, on April 10, 2019, the Company entered into a
securities purchase agreement with Evofem Biosciences, Inc. (“Evofem”), pursuant to which it invested $60.0 million in a private
placement of securities structured in two tranches. To date, the Company has consummated eighteen transactions, ten of which are
active and outstanding. Pursuant to the Company’s monetization strategy, the Company does not expect to enter into any
additional similar transactions.
In September 2019, the Company engaged financial advisors and initiated a review of its strategy. In December 2019, the
Company announced that it had completed a strategic review process and decided to halt the execution of its growth strategy,
cease additional strategic investments and pursue a formal process to unlock value by monetizing our assets and returning net
proceeds to stockholders (the “monetization strategy”). The Company further announced in December 2019 that it would explore
a variety of potential transactions in connection with the monetization strategy, including a sale of the Company, divestiture of the
Company’s assets or businesses, a spin-off transaction, a merger or a combination thereof.
During the first quarter of 2020, the Board of Directors (the “Board”) of the Company approved a plan of complete liquidation
(the “Plan of Liquidation”) and passed a resolution to seek stockholder approval at its next Annual Meeting of Stockholders to
dissolve the Company under Delaware state law in the event the Board concludes that the whole Company sale process is unlikely
to maximize the value that can be returned to the stockholders. The Company has not set a definitive timeline to file for
dissolution and intends to pursue its monetization strategy in a disciplined and cost-effective manner seeking to maximize returns
to stockholders. Subsequently, the Company began a comprehensive program to market and sell its investments. As of March 31,
2020, the Pharmaceutical segment and the royalty right assets within the Income Generating Assets segment met the criteria to be
classified as held for sale. Those investments are reported as discontinued operations on the Condensed Consolidated Statements
of Operations and as Assets and Liabilities held for sale on the Condensed Consolidated Balance Sheets. While the Company
cannot provide a definitive timeline for the liquidation process, it has been targeting the end of 2020 for completing the
monetization of its key assets. However, the Company recognizes that the duration and extent of the public health issues related to
the COVID-19 pandemic make it possible, and perhaps probable, that the timing may be delayed.
Based on the composition of its existing investment portfolio, the Company currently operates in four segments designated as
Medical Devices, Strategic Positions, Pharmaceutical and Income Generating Assets. With the investment in Evofem in the
second quarter of 2019, the Company added the Strategic Positions segment. This did not have any impact on its prior segment
reporting structure.
Our Medical Devices segment consists of revenue derived from the sale and lease of the LENSAR® Laser System made by the
Company’s majority-owned subsidiary, LENSAR, Inc. (“LENSAR”), which may include equipment, Patient Interface Devices
(“PIDs”), procedure licenses, training, installation, warranty and maintenance agreements.
Our Strategic Positions segment consists of an investment in Evofem. Evofem is a publicly-traded (NASDAQ: EVFM) clinical-
stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in
women's sexual and reproductive health. Evofem is leveraging its proprietary Multipurpose Vaginal pH Regulator (MVP-R™)
platform to develop Amphora® (L-lactic acid, citric acid and potassium bitartrate) for hormone-free birth control. Our
investments are expected to provide funding for Evofem's pre-commercial activities for Amphora and include shares of common
48
stock and warrants to purchase additional shares of common stock. Evofem is a pre-commercial company and, as such, is not yet
engaged in revenue-generating activities.
Our Pharmaceutical segment consists of revenue derived from branded prescription medicine products sold under the name
Tekturna® and Tekturna HCT® in the United States and Rasilez® and Rasilez HCT® in the rest of the world and revenue generated
from the sale of an authorized generic form of Tekturna in the United States (collectively, the “Noden Products”). The branded
prescription Noden Products were acquired from Novartis AG, Novartis Pharma AG and Speedel Holding AG (collectively,
“Novartis”) in July 2016 (the “Noden Transaction”) by the Company’s wholly-owned subsidiary, Noden Pharma DAC (“Noden
DAC”). The Company, through its wholly-owned subsidiary, Noden Pharma USA Inc. (“Noden USA”) launched its authorized
generic form of Tekturna in the United States in March 2019.
Our Income Generating Assets segment consists of revenue derived from (i) notes and other long-term receivables, (ii) royalty
rights and hybrid notes/royalty receivables, (iii) equity investments and (iv) royalties from issued patents in the United States and
elsewhere covering the humanization of antibodies, which we refer to as the Queen et al. patents.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying Consolidated Financial Statements of PDL Biopharma, Inc. and its subsidiaries (collectively, the “Company”
or “PDL”) have been prepared in accordance with Generally Accepted Accounting Principles (United States) (“GAAP”).
Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had
no effect on the reported results of operations.
Principles of Consolidation
The Consolidated Financial Statements include the accounts of the Company and its wholly-owned and majority-owned
subsidiaries. All significant intercompany balances and transactions have been eliminated upon consolidation.
A subsidiary is an entity in which the Company, directly or indirectly, controls more than one half of the voting power; has the
power to appoint or remove the majority of the members of the board of directors; to cast a majority of votes at the meeting of the
board of directors or to govern the financial and operating policies of the investee under a statute or agreement among the
stockholders or equity holders.
The Company applies the guidance codified in ASC 810, Consolidations, which requires certain variable interest entities to be
consolidated by the primary beneficiary of the entity in which it has a controlling financial interest. The Company identifies an
entity as a variable interest entity if either: (1) the entity does not have sufficient equity investment at risk to permit the entity to
finance its activities without additional subordinated financial support, or (2) the entity’s equity investors lack the essential
characteristics of a controlling financial interest. The Company performs ongoing qualitative assessments of its variable interest
entities to determine whether the Company has a controlling financial interest in any variable interest entity and therefore is the
primary beneficiary, and if it has the power to direct activities that impact the activities of the entity.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that
affect the amounts reported in the Consolidated Financial Statements and accompanying Notes to the Consolidated Financial
Statements. The accounting estimates that require management’s most significant, difficult and subjective judgments include the
valuation of royalty rights - at fair value, assets and liabilities held for sale, product revenue recognition and allowance for
customer rebates and allowances, the valuation of notes receivable and inventory, the assessment of recoverability of intangible
assets and their estimated useful lives, the valuation and recognition of stock-based compensation, the recognition and
measurement of current and deferred income tax assets and liabilities, and the valuation of warrants to acquire shares of common
stock. Actual results could differ from those estimates.
Segment Reporting
Under ASC 280, Segment Reporting, operating segments are defined as components of an enterprise about which separate
financial information is available that is regularly evaluated by the entity’s chief operating decision maker, in deciding how to
49
allocate resources and in assessing performance. The Company has evaluated its operating segments in accordance with ASC 280
as of December 31, 2019, and has identified four reportable segments: Medical Devices, Strategic Positions, Pharmaceutical and
Income Generating Assets.
Assets Held for Sale
Assets and liabilities are classified as held for sale when all of the following criteria for a plan of sale have been met: (1)
management, having the authority to approve the action, commits to a plan to sell the assets; (2) the assets are available for
immediate sale, in their present condition, subject only to terms that are usual and customary for sales of such assets; (3) an active
program to locate a buyer and other actions required to complete the plan to sell the assets have been initiated; (4) the sale of the
assets is probable and is expected to be completed within one year; (5) the assets are being actively marketed for a price that is
reasonable in relation to their current fair value; and (6) actions required to complete the plan indicate that it is unlikely that
significant changes to the plan will be made or the plan will be withdrawn. When all of these criteria have been met, the assets
and liabilities are classified as held for sale in the balance sheet. Assets classified as held for sale are reported at the lower of their
carrying value or fair value less costs to sell. Depreciation and amortization of assets ceases upon designation as held for sale. The
assets and liabilities held for sale are recorded on the Company’s Consolidated Balance Sheets as Assets held for sale and
Liabilities held for sale, respectively.
Discontinued Operations
Discontinued operations comprise those activities that were disposed of during the period or which were classified as held for sale
at the end of the period, represent a separate major line of business or geographical area that can be clearly distinguished for
operational and financial reporting purposes and represents a strategic shift that has or will have a major effect on the Company’s
operations and financial results. The profits and losses are presented on the Consolidated Statements of Operations as
discontinued operations. See Note 3, Discontinued Operations Classified as Assets Held for Sale, for additional information.
Cash Equivalents
The Company considers all highly liquid investments with initial maturities of three months or less at the date of purchase to be
cash equivalents. The Company places its cash and cash equivalents with high credit quality financial institutions and, by policy,
limits the amount of credit exposure in any one financial instrument.
Accounts Receivable
As of December 31, 2019, the Company concluded that an allowance for doubtful accounts was not required. As of December 31,
2018, the Company had $78,000 in its allowance for doubtful accounts. The Company provides an allowance for doubtful
accounts based on experience and specifically identified risks. Accounts receivable are carried at fair value and charged off
against the allowance for doubtful accounts when the Company determines that recovery is unlikely and the Company ceases
collection efforts.
Investments
As of December 31, 2019 and 2018, the Company’s investments were comprised of an investment in a publicly traded company
and a privately-held company.
The Company’s investment in Evofem qualifies for equity method accounting given its percentage ownership in Evofem and the
ability to exercise significant influence. The Company elected the fair value method to account for its investment in Evofem as it
believes it better reflects economic reality, the financial reporting of the investment and the current value of the asset. Changes in
fair value of the Evofem equity investment are presented in Non-operating income (expense), net on the Consolidated Statement
of Operations.
The Company’s equity security investment in Alphaeon Corporation (“Alphaeon”) qualifies to be measured at fair value, although
it has been determined that the fair value of the investment is not readily determinable as Alphaeon’s shares are not publicly
traded. The Company evaluates the fair value of this investment by performing a qualitative assessment each reporting period. If
the results of this qualitative assessment indicate that the fair value is less than the carrying value, the investment is written down
to its fair value. There have been no such write downs since the Company acquired these shares. This investment is included in
other long-term assets. For additional information on the Alphaeon investment, see Note 8, Notes and Other Long-Term
Receivables.
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Fair Value Measurements
The fair value of the Company’s financial instruments are estimates of the amounts that would be received if the Company were
to sell an asset or the Company paid to transfer a liability in an orderly transaction between market participants at the
measurement date or exit price. The assets and liabilities are categorized and disclosed in one of the following three categories:
Level 1 – based on quoted market prices in active markets for identical assets and liabilities;
Level 2 – based on observable inputs other than quoted prices in active markets for identical assets and liabilities, quoted
prices for identical or similar assets or liabilities in inactive markets, or other inputs that are or can be corroborated by
observable market data for substantially the full term of the assets or liabilities, and
Level 3 – based on unobservable inputs using management’s best estimate and assumptions when inputs are unavailable.
Notes Receivable and Other Long-Term Receivables
The Company accounts for its notes receivable at amortized cost, net of unamortized origination fees, if any, and adjusted for any
impairment losses. Interest is accreted or accrued to “Interest revenue” using the effective interest method. When and if
supplemental payments are received from certain of these notes and other long-term receivables, an adjustment to the estimated
effective interest rate is affected prospectively.
The Company evaluates the collectability of both interest and principal for each note receivable and loan to determine whether it
is impaired. A note receivable or loan is considered to be impaired when, based on current information and events, the Company
determines it is probable that it will be unable to collect amounts due according to the existing contractual terms. When a note
receivable or loan is considered to be impaired, the amount of loss is calculated by comparing the carrying value of the financial
asset to the value determined by discounting the expected future cash flows at the loan’s effective interest rate or to the estimated
fair value of the underlying collateral, less costs to sell, if the loan is collateralized and the Company expects repayment to be
provided solely by the collateral. Impairment assessments require significant judgments and are based on significant assumptions
related to the borrower’s credit risk, financial performance, expected sales, and estimated fair value of the collateral.
The Company records interest on an accrual basis and recognizes it as earned in accordance with the contractual terms of the
credit agreement, to the extent that such amounts are expected to be collected. When a note receivable or loan becomes past due,
or if management otherwise does not expect that principal, interest, and other obligations due will be collected in full, the
Company will generally place the note receivable or loan on an impaired status and cease recognizing interest income on that note
receivable or loan on an accrual basis until all principal and interest due has been paid or until such time that the Company
believes the borrower has demonstrated the ability to repay its current and future contractual obligations. Any uncollected interest
related to prior periods is reversed from income in the period that collection of the interest receivable is determined to be
doubtful. However, the Company may make exceptions to this policy if the investment has sufficient collateral value and is in the
process of collection. Any interest payments received for notes receivable or loans on an impaired status are recognized as interest
income on a cash basis.
For the year ended December 31, 2019, the Company did not recognize any interest revenue for the CareView Communications,
Inc. (“CareView”) note receivable while on impaired status. For the years ended December 31, 2018 and 2017, the Company
recognized $2.3 million and $3.1 million, respectively, of interest revenue for the CareView note receivable as a result of cash
interest payments made during these years.
As of December 31, 2019, the Company had three notes receivable investments which were determined to be impaired with a
cumulative investment cost and fair value of approximately $52.1 million and $57.3 million, respectively. The same three note
receivable investments were determined to be impaired as of December 31, 2018 with a cumulative investment cost and fair value
of approximately $62.8 million and $70.0 million, respectively as of this date. During the years ended December 31, 2019, 2018,
and 2017, the Company did not recognize any losses on extinguishment of notes receivable.
During the years ended December 31, 2019 and 2018, the Company recorded an impairment loss of $10.8 million and $8.2
million, respectively, related to the CareView note receivable. There were no impairment losses on notes receivable for the year
ended December 31, 2017. For additional information about the impairment loss recorded on the CareView note receivable, see
Note 8, Notes and Other Long-Term Receivables.
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Inventory
Inventory, which consists of raw materials, work-in-process and finished goods, is stated at the lower of cost or net realizable
value. The Company determines cost using the first-in, first-out method. Inventory levels are analyzed periodically and written
down to their net realizable value if they have become obsolete, have a cost basis in excess of its expected net realizable value or
are in excess of expected requirements. The Company analyzes current and future product demand relative to the remaining
product shelf life to identify potential excess inventory. The Company builds demand forecasts by considering factors such as, but
not limited to, overall market potential, market share, market acceptance and patient usage. The Company classifies inventory as
current on the Consolidated Balance Sheets when the Company expects inventory to be consumed for commercial use within the
next twelve months.
Intangible Assets
Intangible assets with finite useful lives consist primarily of customer relationships, acquired technology and trademarks and are
amortized on a straight-line basis over their estimated useful lives, over five years to 20 years. The estimated useful lives
associated with finite-lived intangible assets are consistent with the estimated lives of the associated products and may be
modified when circumstances warrant. Such assets are reviewed for impairment when events or circumstances indicate that the
carrying value of an asset may not be recoverable. An impairment loss would be recognized when estimated undiscounted future
cash flows expected to result from the use of an asset and its eventual disposition are less than its carrying amount. The amount of
any impairment is measured as the difference between the carrying amount and the fair value of the impaired asset.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation. Depreciation is computed using the straight-line method
over the following estimated useful lives:
Leasehold improvements............................................................ Lesser of useful life or term of lease
Manufacturing equipment ..........................................................
Computer and office equipment .................................................
Transportation equipment...........................................................
Furniture and fixtures .................................................................
Equipment under lease ............................................................... Greater of lease term or 5-10 years
3-5 years
7 years
3 years
3 years
Convertible Notes
The Company has previously issued convertible notes with settlement features that allow the Company to settle the notes by
paying or delivering, as applicable, cash, shares of the Company’s common stock or a combination of cash and shares of our
common stock, at the Company’s election. In accordance with accounting guidance for convertible debt instruments that may be
settled in cash or other assets on conversion, the Company separated the principal balance between the fair value of the liability
component and the common stock conversion feature using a market interest rate for a similar nonconvertible instrument at the
date of issuance.
Financing Costs Related to Long-term Debt
Costs associated with obtaining long-term debt are deferred and amortized over the term of the related debt using the effective
interest method. Such costs are presented as reductions from the carrying amount of the long-term debt liability, consistent with
debt discounts, on the Company’s Consolidated Balance Sheets.
Revenue Recognition
The reported results for 2019 and 2018 reflect the application of ASC 606, Revenue from Contracts with Customers (“ASC 606”),
while the reported results for 2017 were prepared under the guidance of ASC 605, which is also referred to herein as “legacy
GAAP” or the “previous guidance”.
Policy Elections and Practical Expedients Taken
Upon the Company’s adoption of ASC 606, it elected the following practical expedients:
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Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing
transaction, that are collected by the Company from a customer, are excluded from revenue.
Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are
accounted for as a fulfillment cost and are included in cost of product revenue.
Sales commissions and other incremental costs of obtaining contracts are expensed as incurred as the amortization periods are less
than one year.
General
In accordance with ASC 606, revenue is recognized from the sale of products when a customer obtains control of promised
products and services. The amount of revenue recognized reflects the consideration to which the Company expects to be entitled
to receive in exchange for these products and services. A five-step model is utilized to achieve the core principle and includes the
following steps: (1) identify the customer contract; (2) identify the contract’s performance obligations; (3) determine the
transaction price; (4) allocate the transaction price to the performance obligations; and (5) recognize revenue when the
performance obligations are satisfied.
The following is a description of principal activities - separated by reportable segments - from which the Company generates its
revenue. For more detailed information about reportable segments, see Note 21, Segment Information.
Pharmaceutical
The Company’s Pharmaceutical segment consists of revenue derived from sales of the Noden Products. Noden’s revenue is
included in (Loss) income from discontinued operations.
The agreement between Novartis and Noden DAC provided for various transition periods for development and commercialization
activities relating to the Noden Products. For the period from July 1, 2016 through October 4, 2016, all of the Noden Products
were distributed by Novartis under the terms of the Noden Purchase Agreement while transfer of the marketing authorization
rights were pending. During this time, the Company presented revenue under the Novartis transition arrangement on a “net” basis
and established a reserve for retroactive adjustment to the profit transfer with Novartis. As of the third quarter of 2018, Noden
Pharma DAC completed the marketing authorization transfers for all territories.
In the United States, the duration of the profit transfer ran from July 1, 2016 through October 4, 2016. Beginning on October 5,
2016, Noden Pharma USA, Inc. distributed the Noden Products in the United States. At such time, the Company presented
revenue for all sales in the United States on a “gross” basis, meaning product costs were reported separately and there was no fee
to Novartis, and established a reserve for discounts and allowances further described below.
Initially, Novartis distributed the Noden Products on behalf of Noden DAC worldwide and Noden DAC received a profit transfer
on such sales. Generally, the profit transfer to Noden DAC was defined as gross revenues less product cost and a low single-digit
percentage fee to Novartis. The profit transfer terminated upon the transfer of the marketing authorization from Novartis to Noden
DAC in each country. For the period from October 5, 2016 to August 31, 2017, Novartis continued to distribute the Noden
Products outside of the United States. Beginning on September 1, 2017, Noden Pharma DAC began distributing the Noden
Products to select countries outside the United States. Outside the United States, the profit transfer ended in the first quarter of
2018.
Except for the sales in certain countries outside of the United States preceding the final profit transfer that occurred in the first
quarter of 2018, revenues of the Noden Products for the periods herein are presented on a gross basis.
Noden USA launched an authorized generic of Tekturna in the United States in March 2019.
The Pharmaceutical segment principally generates revenue from products sold to wholesalers and distributors. Customer orders
are generally fulfilled within a few days of receipt resulting in minimal order backlog. Contractual performance obligations are
usually limited to transfer of the product to the customer. The transfer occurs either upon shipment or upon receipt of the product
in certain countries outside the United States after considering when the customer obtains control of the product. In addition, in
some countries outside of the United States, the Company sells product on a consignment basis where control is not transferred
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until the customer resells the product to an end user. At these points, customers are able to direct the use of and obtain
substantially all of the remaining benefits of the product.
Sales to customers are initially invoiced at contractual list prices. Payment terms are typically 30 to 90 days based on customary
practice in each country. Revenue is reduced from the list price at the time of recognition for expected chargebacks, discounts,
rebates, sales allowances and product returns, which are collectively referred to as gross-to-net adjustments. These reductions are
attributed to various commercial agreements, managed healthcare organizations and government programs such as Medicare,
Medicaid, and the 340B Drug Pricing Program containing various pricing implications such as mandatory discounts, pricing
protection below wholesaler list price and other discounts when Medicare Part D beneficiaries are in the coverage gap. These
various reductions in the transaction price have been estimated using either a most likely amount, in the case of prompt pay
discounts, or expected value method for all other variable consideration and have been reflected as liabilities and are settled
through cash payments, typically within time periods ranging from a few months to one year. Significant judgment is required in
estimating gross-to-net adjustments considering legal interpretations of applicable laws and regulations, historical experience,
payer channel mix, current contract prices under applicable programs, unbilled claims, processing time lags and inventory levels
in the distribution channel. A description of gross-to-net adjustments are described below.
Customer Credits: The Company’s customers are offered various forms of consideration, including allowances, service fees and
prompt payment discounts. The Company expects customers will earn prompt payment discounts and, therefore, the Company
deducts the full amount of these discounts from total product sales when revenues are recognized. Service fees are also deducted
from total product sales as they are earned.
Rebates and Discounts: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program in the
United States and mandated discounts in the European Union (“EU”) in markets where government-sponsored healthcare systems
are the primary payers for healthcare. Rebates are amounts owed after the final dispensing of the product to a benefit plan
participant and are based upon contractual agreements or legal requirements with public sector benefit providers. The accrual for
rebates is based on negotiated discount rates and expected utilization as well as historical data. Estimates for expected utilization
of rebates are based on data received from the customers. Rebates are generally invoiced and paid in arrears so that the accrual
balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for
known prior quarters’ unpaid rebates. If actual future rebates vary from estimates, the Company may need to adjust prior period
accruals, which would affect revenue in the period of adjustment.
Chargebacks: Chargebacks are discounts that occur when certain contracted customers, which currently consist primarily of
group purchasing organizations, Public Health Service institutions, non-profit clinics, and Federal government entities purchasing
via the Federal Supply Schedule, purchase directly from the Company’s wholesalers. Contracted customers generally purchase the
product at a discounted price. The wholesalers, in turn, charges back to the Company the difference between the price initially
paid by the wholesalers and the discounted price paid by the contracted customers. In addition to actual chargebacks received, the
Company maintains an accrual for chargebacks based on the estimated contractual discounts on products sold for which the
chargeback has not been billed. If actual future chargebacks vary from these estimates, the Company may need to adjust prior
period accruals, which would affect revenue in the period of adjustment.
Medicare Part D Coverage Gap: Medicare Part D prescription drug benefit mandates manufacturers to fund 70% in 2019 and
50% in 2018 and 2017 of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Estimates
for the expected Medicare Part D coverage gap are based on historical invoices received and in part from data received from the
Company’s customers. Funding of the coverage gap is generally invoiced and paid in arrears so that the accrual balance consists
of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known prior
quarters. If actual future funding varies from estimates, the Company may need to adjust prior period accruals, which would affect
revenue in the period of adjustment.
Co-payment Assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-
payment assistance. The Company accrues a liability for co-payment assistance based on actual program participation and
estimates of program redemption using data provided by third-party administrators.
Returns: Returns are generally estimated and recorded based on historical sales and returns information. Products that exhibit
unusual sales or return patterns due to dating, competition or other marketing matters are specifically investigated and analyzed as
part of the accounting for sales returns accruals.
Reserves for chargebacks, discounts, rebates, sales allowances and product returns are included within Liabilities held for sale in
the Company’s Consolidated Balance Sheets.
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For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined
performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and,
if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front
license fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of
performance and related revenue recognition.
Medical Devices
The Medical Devices segment principally generates revenue from the sale and lease of the LENSAR® Laser System, which may
include equipment, PIDs or consumables, procedure licenses, training, installation, warranty and maintenance agreements.
For bundled packages, the Company accounts for individual products and services separately if they are distinct - i.e. if a product
or service is separately identifiable from other items in the bundled package and if the customer can benefit from it on its own or
with other resources that are readily available to the customer. The LENSAR® Laser System, standard warranty, training and
installation services are one performance obligation. All other elements are separate performance obligations. PIDs, procedure
licenses, warranty and maintenance services are also sold on a stand-alone basis.
As the Company both sells and leases the LENSAR® Laser System, the consideration (including any discounts) is first allocated
between lease and non-lease components and then allocated between the separate products and services based on their stand-alone
selling prices. The stand-alone selling prices for the PIDs and procedure licenses are determined based on the prices at which the
Company separately sells the PIDs and procedure licenses. The LENSAR® Laser System and warranty stand-alone selling prices
are determined using the expected cost plus a margin approach.
For LENSAR® Laser System sales, the Company recognizes Product revenue when a customer takes possession of the system.
This usually occurs after the customer signs a contract, LENSAR installs the system, and LENSAR performs the requisite training
for use of the system. For LENSAR® Laser System leases, the Company recognized Product revenue over the length of the lease
in accordance with ASC Topic 840, through December 31, 2018 and recognizes Product revenue in accordance with ASC Topic
842, Leases, after January 1, 2019. For additional information regarding accounting for leases, see Note 9, Leases.
The LENSAR® Laser System requires both a consumable and a procedure license to perform each procedure. The Company
recognizes Product revenue for PIDs when the customer takes possession of the PID. PIDs are sold by the case. The Company
recognizes Product revenue for procedure licenses when a customer purchases a procedure license from the web portal. Typically,
consideration for PIDs and procedure licenses is considered fixed consideration except for certain customer agreements that
provide for tiered volume discount pricing, which is considered variable consideration.
The Company offers an extended warranty that provides additional services beyond the standard warranty. The Company
recognizes Product revenue from the sale of extended warranties over the warranty period. Customers have the option of
renewing the warranty period, which is considered a new and separate contract.
Income Generating Assets
For licenses of intellectual property, if the license to the Company’s intellectual property is determined to be distinct from the
other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front
fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the
license.
In January 2018, DFM, LLC, a wholly-owned subsidiary of the Company, granted an exclusive license related to certain Direct
Flow Medical, Inc. assets in exchange for $0.5 million in cash and up to $2.0 million in royalty payments. The $0.5 million
payment was accounted for in accordance with ASC 606 under which the full cash payment was recognized as revenue in the first
quarter of 2018 as DFM, LLC had fulfilled its performance obligation under the agreement. In September 2019, the remaining
assets of DFM, LLC were sold for $5.0 million.
Queen et al. Royalty Revenues
Under the Company’s license agreements related to the Queen et al. patents, the Company receives royalty payments based upon
its licensees’ net sales of covered products. Royalties qualify for the sales-and-usage exemption under ASC 606 as (i) royalties are
based strictly on the sales-and-usage by the licensee; and (ii) a license of intellectual property is the sole or predominant item to
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which such royalties relate. Based on this exemption, these royalties are earned under the terms of a license agreement in the
period the products are sold by the Company's partner and the Company has a present right to payment. Generally, under these
agreements, the Company receives royalty reports from its licensees approximately one quarter in arrears; that is, generally in the
second month of the quarter after the licensee has sold the royalty-bearing product. The Company recognizes royalty revenues
when it can reliably estimate such amounts and collectability is reasonably assured. Under this accounting policy, the royalty
revenues the Company reports are not based upon estimates, and such royalty revenues are typically reported in the same period
in which the Company receives payment from its licensees.
Although the last of the Queen et al. patents expired in December 2014, the Company has received royalties beyond expiration
based on the terms of its licenses and its legal settlement. Under the terms of the legal settlement between Genentech, Inc.
(“Genentech”) and the Company, the first quarter of 2016 was the last period for which Genentech paid royalties to the Company
for Avastin®, Herceptin®, Xolair®, Perjeta® and Kadcyla®. Other products from the Queen et al. patent licenses, such as Tysabri®,
entitle the Company to royalties following the expiration of its patents with respect to sales of licensed product manufactured
prior to patent expiry in jurisdictions providing patent protection licenses. In November 2017, the Company was notified by
Biogen, Inc. that product supply for Tysabri® that was manufactured prior to patent expiry, and for which the Company would
receive royalties on, had been extinguished in the United States and was rapidly being reduced in other countries. As a result,
royalties from product sales of Tysabri were substantially lower in 2018 and 2019 and no additional royalties are expected.
Royalty Rights - At Fair Value
The Company accounts for its investments in royalty rights at fair value with changes in fair value presented in earnings. The fair
value of the investments in royalty rights is determined by using a discounted cash flow analysis related to the expected future
cash flows to be received. These assets are classified as Level 3 assets within the fair value hierarchy, as the Company’s valuation
estimates utilize significant unobservable inputs, including estimates as to the probability and timing of future sales of the related
products. Transaction-related fees and costs are expensed as incurred.
The changes in the estimated fair value from investments in royalty rights along with cash receipts in each reporting period are
presented together on the Company’s Consolidated Statements of Operations as (Loss) income from discontinued operations
before income taxes.
Realized gains and losses on royalty rights are recognized as they are earned and when collection is reasonably assured. Royalty
Rights revenue is recognized over the respective contractual arrangement period. Critical estimates may include product demand
and market growth assumptions, inventory target levels, product approval, pricing assumptions and the impact of competition
from other branded or generic products. Factors that could cause a change in estimates of future cash flows include a change in
estimated market size, a change in pricing strategy or reimbursement coverage, a delay in obtaining regulatory approval, a change
in dosage of the product a change in the number of treatments and the entrants of new competitors or generic products. For each
arrangement, the Company is entitled to royalty payments based on revenue generated by the net sales of the product.
Research and Development
The Company expenses research and development costs as incurred. Research and development expenses consist primarily of
engineering, product development, clinical studies to develop and support the Company’s products, regulatory expenses, and
other costs associated with products and technologies that are in development. Research and development expenses include
employee compensation, including stock-based compensation, supplies, consulting, prototyping, testing, materials, travel
expenses, and depreciation.
Foreign Currency Translation
The Company uses the U.S. dollar predominately as the functional currency of its foreign subsidiaries. For foreign subsidiaries
where the U.S. dollar is the functional currency, gains and losses from remeasurement of foreign currency balances into U.S.
dollars are included in the Consolidated Statements of Operations. The aggregate net (losses) gains resulting from foreign
currency transactions and remeasurement of foreign currency balances into U.S. dollars that were included in the Consolidated
Statements of Operations amounted to a loss of $0.5 million and $0.7 million for the years ended December 31, 2019 and 2018,
respectively and a $0.1 million gain for the year ended December 31, 2017.
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Comprehensive (Loss) Income
Comprehensive (loss) income comprises net (loss) income adjusted for other comprehensive (loss) income, using the specific
identification method, which includes the changes in unrealized gains and losses on cash flow hedges and changes in unrealized
gains and losses on the Company’s investments in available-for-sale securities, all net of tax, which are excluded from the
Company’s net (loss) income.
Income Taxes
The provision for income taxes is determined using the asset and liability approach. Tax laws require items to be included in tax
filings at different times than the items are reflected in the Consolidated Financial Statements. A current liability is recognized for
the estimated taxes payable for the current year. Deferred taxes represent the future tax consequences expected to occur when the
reported amounts of assets and liabilities are recovered or paid. Deferred taxes are adjusted for enacted changes in tax rates and
tax laws. Valuation allowances are recorded to reduce deferred tax assets when it is more likely than not that a tax benefit will not
be realized.
The Company recognizes tax benefits from uncertain tax positions only if it is more likely than not that the tax position will be
sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in
the consolidated financial statements from such positions are then measured based on the largest benefit that has a greater than
50% likelihood of being realized upon ultimate settlement. The Company adjusts the level of the liability to reflect any
subsequent changes in the relevant facts surrounding the uncertain positions. Any interest and penalties on uncertain tax positions
are included within the tax provision.
The Tax Cuts and Job Act of 2017 (the “2017 Tax Act”) significantly changed the existing U.S. corporate income tax laws by,
among other things, lowering the corporate tax rate (from a top rate of 35% to a flat rate of 21%), implementing elements of a
territorial tax system, and imposing a one-time deemed repatriation transition tax on cumulative undistributed foreign earnings,
for which the Company has not previously paid U.S. taxes. The Company recognized the estimated tax impact related to the
revaluation of deferred tax assets and liabilities in its Consolidated Financial Statements for the year ended December 31, 2017.
The ultimate impact did not differ materially from these provisional amounts after additional analysis, changes in interpretations
and assumptions the Company made and additional regulatory guidance that was issued. The accounting was completed when the
Company’s 2017 U.S. corporate income tax return was filed in 2018. The Company has made a policy election with respect to its
treatment of potential global intangible low-taxed income (“GILTI”) to account for taxes on GILTI as a current-period expense as
incurred.
Business Combination
The Company applies ASC 805, Business combinations (“ASC 805”), pursuant to which the cost of an acquisition is measured as
the aggregate of the fair values at the date of exchange of the assets given, liabilities incurred, and equity instruments issued. The
costs directly attributable to the acquisition are expensed as incurred. Identifiable assets, liabilities and contingent liabilities
acquired or assumed are measured separately at their fair value as of the acquisition date, irrespective of the extent of any
noncontrolling interests. The excess of the (i) the total of cost of acquisition, fair value of the noncontrolling interests and
acquisition date fair value of any previously held equity interest in the acquiree over (ii) the fair value of the identifiable net assets
of the acquiree is recorded as goodwill. If the cost of an acquisition is less than the fair value of the net assets of the subsidiary
acquired, the difference is recognized directly in the Consolidated Statements of Operations as a bargain purchase gain.
Leases
General
In February 2016, the FASB issued ASU No. 2016-02, Leases, that supersedes ASC 840, Leases. Subsequently, the FASB issued
several updates to ASU No. 2016-02, codified in ASC Topic 842 (“ASC 842”). The Company adopted ASC 842, Leases, on
January 1, 2019 using the modified retrospective method for all leases not substantially completed as of the date of adoption. The
reported results for the year ended December 31, 2019 reflect the application of ASC 842 guidance while the reported results for
the years ended December 31, 2018 and 2017 were prepared under the guidance of ASC 840, which is also referred to herein as
“legacy GAAP” or the “previous guidance”. The cumulative impact of the adoption of ASC 842 was not material, therefore, the
Company did not record any adjustments to retained earnings. As a result of adopting ASC 842, the Company recorded operating
lease right-of-use (“ROU”) assets of $2.1 million and operating lease liabilities of $2.1 million, primarily related to corporate
office leases, based on the present value of the future lease payments on the date of adoption. Changes to lessor accounting
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focused on conforming with certain changes made to lessee accounting and the recently adopted revenue recognition guidance.
The adoption of ASC 842 did not materially change how the Company accounts for lessor arrangements.
The Company determines if an arrangement is a lease or contains an embedded lease at inception if it contains the right to control
the use of an identified asset under a leasing arrangement with an initial term greater than 12 months. The Company determines
whether a contract conveys the right to control the use of an identified asset for a period of time if the contract contains both the
right to obtain substantially all of the economic benefits from the use of the identified asset and the right to direct the use of the
identified asset. The Company has lease arrangements with lease and non-lease components, which are accounted for separately.
Policy Elections and Practical Expedients Taken
For leases that commenced before the effective date of ASC 842, the Company elected the practical expedients to not reassess the
following: (i) whether any expired or existing contracts contain leases; (ii) the lease classification for any expired or existing
leases; and (iii) initial direct costs for any existing leases.
The Company adopted a policy of expensing short-term leases, defined as 12 months or less, as incurred.
The Company has a policy to exclude from the consideration in a lessor contract all taxes assessed by a governmental authority
that are both imposed on and concurrent with a specific lease revenue-producing transaction and collected by the Company from a
lessee.
Lessee arrangements
Lessee operating leases are included in Other assets, Accrued liabilities, and Other long-term liabilities in the Company’s
Consolidated Balance Sheet. The Company does not have lessee financing leases.
Operating lease ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities
represent its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized
at commencement date based on the present value of lease payments over the lease term. The Company uses the implicit rate
when readily determinable at lease inception. As most of the Company’s leases do not provide an implicit rate, the Company uses
its incremental borrowing rate based on the information available at commencement date in determining the present value of lease
payments. The Company’s remaining lease terms may include options to extend or terminate the lease when it is reasonably
certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis as
operating expense in the Consolidated Statements of Operations over the lease term.
For lease arrangements with lease and non-lease components where the Company is the lessee, the Company separately accounts
for lease and non-lease components, which consists primarily of taxes and common area maintenance costs. Non-lease
components are expensed as incurred.
Lessor arrangements
The Company leases medical device equipment to customers in both operating lease and sales-type lease arrangements generated
from its Medical Devices segment.
For sales-type leases, the Company derecognizes the carrying amount of the underlying asset and capitalizes the net investment in
the lease, which consists of the total minimum lease payments receivable from the lessee, at lease inception. The Company does not
estimate an unguaranteed residual value of the equipment at lease termination because the equipment transfers to the lessee upon
completion of the lease. Selling profit or loss is recognized at lease inception. Initial direct costs are recognized as an expense, unless
there is no selling profit or loss. If there is no selling profit or loss, initial direct costs are deferred and recognized over the lease term.
The Company recognizes interest income from the lease receivable over the lease term in Interest and other income, net in the
Consolidated Statements of Operations.
For operating leases, rental income is recognized on a straight-line basis over the lease term. The cost of customer-leased equipment
is recorded within Property and equipment, net in the accompanying Consolidated Balance Sheets and depreciated over the
equipment’s estimated useful life. Depreciation expense associated with the leased equipment under operating lease arrangements
is reflected in Cost of product revenue in the accompanying Consolidated Statements of Operations. Some of the Company’s operating
leases include a purchase option for the customer to purchase the leased asset at the end of the lease arrangement. The Company
manages its risk on its investment in the equipment through pricing and the term of the leases. Lessees do not provide residual value
guarantees on leased equipment. Equipment returned to the Company may be leased or sold to other customers. Initial direct costs
are deferred and recognized over the lease term.
58
Leases are generally not cancellable until after an initial term and may or may not require the customer to purchase a minimum
number of procedures and consumables throughout the contract term.
For lease arrangements with lease and non-lease components where the Company is the lessor, the Company allocates the
contract’s transaction price to the lease and non-lease components on a relative standalone selling price basis using the
Company’s best estimate of the standalone selling price of each distinct product or service in the contract. Allocation of the
transaction price is determined at the inception of the lease arrangement. The Company’s leases primarily consist of leases with
fixed lease payments. For those leases with variable lease payments, the variable lease payment is typically based upon use of the
leased equipment or the purchase of procedure licenses and consumables used with the leased equipment. Non-lease components
are accounted for under ASC 606. For additional information regarding ASC 606, see Note 20, Revenue from Contracts with
Customers.
Adopted Accounting Pronouncements
Intangibles-Goodwill and Other
In January 2017, the FASB issued ASU 2017-04, Intangibles-Goodwill and Other: Simplifying the Test for Goodwill Impairment,
to simplify the subsequent measurement of goodwill by eliminating step two from the goodwill impairment test. Under the
amendments, an entity will recognize an impairment charge for the amount by which the carrying value exceeds the fair value.
The amendments are effective for fiscal years and interim periods within those years beginning after December 15, 2019 on a
prospective basis and early adoption is permitted. Effective January 1, 2019, the Company adopted the requirements of ASU No.
2017-04. The adoption did not have an effect on the Consolidated Financial Statements on the adoption date and no adjustment to
prior year Consolidated Financial Statements was required.
Recently Issued Accounting Pronouncements
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on
Financial Instruments. The new guidance amends the impairment model to utilize an expected loss methodology in place of the
currently used incurred loss methodology, which will result in more timely recognition of losses. ASU No. 2016-13 has an
effective date of the fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. The
Company does not expect this guidance to have a significant impact on its financial statements and related disclosures.
In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement. The new guidance modifies disclosure
requirements related to fair value measurement. The amendments in ASU No. 2018-13 are effective for fiscal years, and interim
periods within those fiscal years, beginning after December 15, 2019. Implementation on a prospective or retrospective basis
varies by specific disclosure requirement. Early adoption is permitted. The standard also allows for early adoption of any removed
or modified disclosures upon issuance of ASU No. 2018-13 while delaying adoption of the additional disclosures until their
effective date. The Company does not expect this guidance to have a significant impact on its financial statements and related
disclosures.
In August 2018, the FASB issued ASU No. 2018-15, Intangibles-Goodwill and Other-Internal-Use Software. The new guidance
reduces complexity for the accounting for costs of implementing a cloud computing service arrangement and aligns the
requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the
requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements
that include an internal use software license). For public companies, the amendments in ASU No. 2018-15 are effective for fiscal
years, and interim periods within those fiscal years, beginning after December 15, 2019, with early adoption permitted.
Implementation should be applied either retrospectively or prospectively to all implementation costs incurred after the date of
adoption. The Company does not expect this guidance to have a significant impact on its financial statements and related
disclosures.
In December 2019, the FASB issued ASU No. 2019-12, Income Taxes: Simplifying the Accounting for Income Taxes. This
guidance removes certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating
income taxes in an interim period, and the recognition of deferred tax liabilities for outside basis differences. This guidance also
clarifies and simplifies other areas of ASC 740. This ASU will be effective for public companies for fiscal years, and interim
periods within those fiscal years beginning after December 15, 2020. Early adoption is permitted. Certain amendments in this
update must be applied on a prospective basis, certain amendments must be applied on a retrospective basis, and certain
amendments must be applied on a modified retrospective basis through a cumulative-effect adjustment to retained earnings/
59
(deficit) in the period of adoption. The Company is currently evaluating the impact this ASU will have on the Company’s
financial statements and related disclosures as well as the timing of adoption.
3. Discontinued Operations Classified as Assets Held for Sale
As discussed in Note 1, Organization and Business, in September 2019, the Company engaged financial advisors and initiated a
review of its strategy. In December 2019, the Company announced that it had completed a strategic review process and decided to
halt the execution of its growth strategy, cease additional strategic investments and pursue a formal process to unlock value by
monetizing our assets and returning net proceeds to stockholders (the “monetization strategy”). The Company further announced
in December 2019 that it would explore a variety of potential transactions in connection with the monetization strategy, including
a sale of the Company, divestiture of the Company’s assets or businesses, a spin-off transaction, a merger or a combination
thereof.
In March 2020, the Company announced its Plan of Liquidation and passed a resolution to seek stockholder approval at its next
Annual Meeting of Stockholders to dissolve the Company under Delaware state law in the event that the Board concludes that a
whole Company sale is unlikely to maximize the value that can be returned to the stockholders. The Company has not set a
definitive timeline for the liquidation and intends to pursue the liquidation strategy in a disciplined and cost-effective manner
seeking to maximize the value that can be returned to stockholders. As a result of these actions and subsequent efforts to monetize
the Company’s key assets, as well as the sale of these key assets representing a strategic shift in the operations of the Company,
the assets held for sale and discontinued operations criteria were met for the Company’s royalty assets (Income Generating Assets
segment) and its subsidiary Noden (Pharmaceutical segment) during the first quarter of 2020. The historical financial results of
the royalty assets and Noden are reflected in the Company’s consolidated financial statements as discontinued operations, for all
periods presented, and assets and liabilities were retrospectively reclassified as assets and liabilities held for sale.
Components of amounts reflected in (Loss) income from discontinued operations are as follows:
(in thousands)
Revenues
Year Ended December 31,
2019
2018
2017
Product revenue, net ...........................................................................................
$
55,093
$
80,796
$
Royalty rights - change in fair value ..................................................................
Total revenues..........................................................................................................
Operating expenses
Cost of product revenue (excluding intangible asset amortization) ...................
Amortization of intangible assets .......................................................................
General and administrative.................................................................................
Sales and marketing............................................................................................
Research and development.................................................................................
Impairment of intangible assets..........................................................................
Change in fair value of anniversary payment and contingent consideration .....
Total operating expenses..........................................................................................
(Loss) income from discontinued operations before income taxes .........................
Income tax (benefit) expense from discontinued operations..............................
(31,042)
24,051
36,343
5,016
7,059
1,675
(41)
22,490
—
72,542
(48,491)
(2,028)
85,287
166,083
34,906
14,536
11,720
10,800
196
152,330
(42,000)
182,488
(16,405)
19,689
(Loss) income from discontinued operations ......................................................
$
(46,463) $
(36,094) $
69,032
159,729
228,761
18,333
24,057
10,268
14,021
5,963
—
349
72,991
155,770
58,421
97,349
60
The carrying amounts of the major classes of assets reported as “Assets held for sale” consist of the following:
(in thousands)
December 31, 2019
December 31, 2018
Cash and cash equivalents .............................................................................
Accounts receivable, net................................................................................
Inventory........................................................................................................
Prepaid and other current assets ....................................................................
Property and equipment, net..........................................................................
Royalty rights - at fair value..........................................................................
Intangible assets, net......................................................................................
Other assets....................................................................................................
Total assets held for sale ...........................................................................
$
$
24,469
$
6,993
31,712
7,192
2,960
266,196
10,112
1,819
351,453
$
28,910
16,874
14,880
4,480
3,681
376,510
37,618
2,236
485,189
The carrying amounts of the major classes of liabilities reported as “Liabilities held for sale” consist of the following:
(in thousands)
December 31, 2019
December 31, 2018
Accounts payable..........................................................................................
Accrued liabilities.........................................................................................
Other long-term liabilities.............................................................................
Total liabilities held for sale.....................................................................
$
$
14,695
$
16,400
120
31,215
$
10,614
30,086
—
40,700
4. Investment in Evofem Biosciences, Inc.
On April 10, 2019, the Company entered into a securities purchase agreement with Evofem and two other purchasers, pursuant to
which the Company purchased $60.0 million of Evofem securities in a private placement. The transaction was structured in two
tranches.
The first tranche closed on April 11, 2019, pursuant to which the Company invested $30.0 million to purchase 6,666,667 shares of
Evofem common stock at $4.50 per share and was also issued warrants to purchase up to 1,666,667 shares of Evofem common
stock. The warrants are exercisable beginning six months after the issuance date for a period of seven years from the issuance date
at an exercise price of $6.38 per share.
The second tranche closed on June 10, 2019, pursuant to which the Company invested an additional $30.0 million to purchase an
additional 6,666,667 shares of Evofem common stock at $4.50 per share and was also issued warrants to purchase up to an
additional 1,666,667 shares of Evofem common stock with the same terms as the warrants issued in the first tranche. Following
the closing of the second tranche, the Company has a right to appoint one member to Evofem’s board of directors and has a
limited right to have one board observer participate in Evofem board meetings. In December 2019, the Company’s representatives
resigned from these positions. Since that time, the Company has elected not to appoint a director or board observer to the Evofem
board of directors but retains the right to do so.
The Company has registration rights on customary terms for all Evofem shares issued under the securities purchase agreement,
including the shares underlying the warrants.
As of December 31, 2019, the Company owned approximately 28% of Evofem’s common stock. The Company’s investment in
Evofem qualifies for equity method accounting given its percentage ownership in Evofem and the ability to exercise significant
influence. The Company elected the fair value method to account for its investment in Evofem as it believes it better reflects
economic reality, the financial reporting of the investment and the current value of the asset. Changes in fair value of the Evofem
equity investment are presented in Non-operating income (expense), net on the Consolidated Statement of Operations. Because
the mark to market valuation will occur at the end of each quarterly reporting period, changes in fair value will vary based upon
the volatility of the stock price. The Evofem equity investment is presented on the Consolidated Balance Sheet as an Investment
in equity affiliate and reflects the fair value of the equity investment at the end of the reporting period.
61
For the year ended December 31, 2019, the Company had an unrealized gain of $36.4 million on its investment in Evofem, of
which $31.6 million was related to Evofem common stock and $4.8 million was related to Evofem warrants.
The latest Evofem financial statements can be found on their corporate website at www.evofem.com or filed with the SEC at
www.sec.gov.
5. Cash and Cash Equivalents
As of December 31, 2019 and 2018, the Company had invested its excess cash balances primarily in cash and money market
funds. The fair values of cash equivalents approximate their carrying values due to the short-term nature of such financial
instruments.
The following table summarizes the Company’s cash and cash equivalents by significant investment category reported as cash and
cash equivalents as of December 31, 2019 and 2018:
(in thousands)
December 31, 2019
Amortized
Cost
Estimated
Fair Value
Cash and Cash
Equivalents
Reported as:
Cash..............................................................................................................................
Money market funds.....................................................................................................
Total 1.......................................................................................................................
$ 37,718
$ 37,718
131,264
131,264
$ 168,982
$ 168,982
December 31, 2018
Cash..............................................................................................................................
Money market funds.....................................................................................................
Total 1.......................................................................................................................
$ 138,961
$ 138,961
226,719
$ 365,680
226,719
$ 365,680
$
$
$
$
37,718
131,264
168,982
138,961
226,719
365,680
________________
1 The amounts above exclude $24.5 million and $28.9 million of cash at Noden classified as held for sale as of December 31, 2019
and 2018, respectively. See Note 3, Discontinued Operations Classified as Assets Held for Sale, for additional information.
The Company recognized approximately $0.8 million and $0.1 million, respectively, of gains on sales of available-for-sale
securities in the years ended December 31, 2018 and 2017, respectively. As of December 31, 2019 and 2018 the Company did not
have any available-for-sale securities.
6. Inventories
Inventories consisted of the following:
(in thousands)
December 31,
2019
2018
Raw materials....................................................................................................................................
Work in process.................................................................................................................................
Finished goods ..................................................................................................................................
Total inventories 1.........................................................................................................................
$
$
3,739
$
1,170
3,152
8,061
$
1,921
549
1,592
4,062
1 The amounts above exclude $31.7 million and $14.9 million of inventory at Noden classified as held for sale as of
December 31, 2019 and 2018, respectively. See Note 3, Discontinued Operations Classified as Assets Held for Sale, for
additional information.
62
7. Fair Value Measurements
Assets/Liabilities Measured and Recorded at Fair Value on a Recurring Basis
The following table presents the fair value of the Company’s financial instruments measured at fair value on a recurring basis by
level within the valuation hierarchy, as discussed in Note 2, Summary of Significant Accounting Policies:
(in thousands)
Financial assets:
Money market funds........
Corporate securities 1.......
Warrants 2 ........................
Royalty rights - at fair
value ................................
Total ............................
Level 1
December 31, 2019
Level 3
Level 2
Total
Level 1
December 31, 2018
Level 3
Level 2
Total
$ 131,264
82,267
$
— $
—
— $ 131,264
82,267
—
$ 226,719
—
$
—
—
14,152
—
14,152
— 266,196
266,196
—
—
— $
—
62
— $ 226,719
—
—
—
62
— 376,510
376,510
$ 213,531
$ 14,152
$ 266,196
$ 493,879
$ 226,719
$
62
$ 376,510
$ 603,291
Financial liabilities:
Contingent consideration,
current 3 ...........................
Total ............................
$
$
— $
— $
— $
— $
— $
— $
— $
— $
— $
— $
— $
— $
1,071
1,071
$
$
1,071
1,071
___________________
1 Corporate securities are classified as “Investment in equity affiliate” on the December 31, 2019 Consolidated Balance
Sheet.
2 Warrants are included in “Other assets” on the December 31, 2019 and 2018 Consolidated Balance Sheets.
3 Contingent consideration, current is included in “Accrued liabilities” on the December 31, 2018 Consolidated Balance
Sheet.
There have been no transfers between levels during the periods presented in the table above. The Company recognizes transfers
between levels on the date of the event or change in circumstances that caused the transfer.
Money Market Funds - The fair values of cash equivalents approximate their carrying values due to the short-term nature of such
financial instruments.
Corporate Securities - Corporate securities consists of common stock shares of Evofem, a clinical-stage biopharmaceutical
company listed on Nasdaq. For additional information on the Evofem investment, see Note 4, Investment in Evofem.
Warrants - Warrants consist of rights to purchase shares of common stock in Evofem and CareView, see Note 4, Investment in
Evofem, and Note 8, Notes and Other Long-Term Receivables. The fair value of the warrants is estimated using recently quoted
market prices of the underlying equity security and the Black-Scholes option pricing model.
Royalty Rights - At Fair Value
Assertio (Depomed) Royalty Agreement
On October 18, 2013, the Company entered into the Royalty Purchase and Sale Agreement (the “Assertio Royalty Agreement”)
with Assertio Therapeutics, Inc. (formerly known as Depomed, Inc.), and Depo DR Sub, LLC (together, “Assertio”), whereby the
Company acquired the rights to receive royalties and milestones payable on sales of five Type 2 diabetes products licensed by
Assertio in exchange for a $240.5 million cash payment. Total consideration was $241.3 million, which was comprised of the
$240.5 million cash payment to Assertio and $0.8 million in transaction costs.
The rights acquired include Assertio’s royalty and milestone payments accruing from and after October 1, 2013: (a) from
Santarus, Inc., which was subsequently acquired by Salix Pharmaceuticals, Inc., which itself was acquired by Valeant
Pharmaceuticals International, Inc. (“Valeant”), which, in July 2018, changed its name to Bausch Health Companies Inc.
(“Bausch Health”) with respect to sales of Glumetza (metformin HCL extended-release tablets) in the United States; (b) from
Merck & Co., Inc. with respect to sales of Janumet® XR (sitagliptin and metformin HCL extended-release tablets); (c) from
63
Janssen Pharmaceutica N.V. with respect to potential future development milestones and sales of its approved fixed-dose
combination of Invokana® (canagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor) and extended-release metformin
tablets, marketed as Invokamet XR®; (d) from Boehringer Ingelheim and Eli Lilly and Company with respect to potential future
development milestones and sales of the investigational fixed-dose combinations of drugs and extended-release metformin subject
to Assertio’s license agreement with Boehringer Ingelheim, including its approved products, Jentadueto XR® and Synjardy XR®;
and (e) from Bausch Health for sales of extended-release metformin tablets in Korea and Canada, respectively.
In February 2013, a generic equivalent to Glumetza was approved by the U.S. Food and Drug Administration (“FDA”) and in
August 2016, two additional generic equivalents to Glumetza were approved by the FDA. In February 2016, Lupin
Pharmaceuticals, Inc., in August 2017, Teva Pharmaceutical Industries Ltd., and in July 2018, Sun Pharmaceutical, Inc. (“Sun”)
each launched a generic equivalent approved product. In May 2017, the Company received notification that a subsidiary of
Valeant had launched an authorized generic equivalent product in February 2017, and the Company received royalties on such
authorized generic equivalent product under the same terms as the branded Glumetza product, retroactive to February 2017. The
Company continues to monitor whether the generic competition further affects sales of Glumetza and thus royalties on such sales
paid to the Company, and the impact of the launched authorized generic equivalent. Due to the uncertainty around Bausch
Health’s marketing and pricing strategy, as well as Sun’s recently launched generic product and limited historical demand data
after generic market entrance, the Company may need to further evaluate future cash flows in the event of more rapid reduction or
increase in market share of Glumetza and its authorized generic equivalent product and/or a further erosion in net pricing.
The Company determined that its royalty purchase interest in Depo DR Sub, LLC represented a variable interest in a variable
interest entity. However, the Company did not have the power to direct the activities of Depo DR Sub, LLC that most
significantly impact Depo DR Sub, LLC’s economic performance and was not the primary beneficiary of Depo DR Sub, LLC;
therefore, Depo DR Sub, LLC was not subject to consolidation by the Company.
On August 2, 2018, PDL Investment Holding, LLC (“PDLIH”), a wholly-owned subsidiary of the Company and assignee from
the Company under the Assertio Royalty Agreement, entered into an amendment to the Assertio Royalty Agreement with Assertio.
Pursuant to the amendment, PDLIH purchased all of Assertio’s remaining interests in royalty and milestone payments payable on
sales of Type 2 diabetes products licensed by Assertio for $20.0 million. Prior to the amendment, the Assertio Royalty Agreement
provided that the Company would have received all royalty and milestone payments due under license agreements between
Assertio and its licensees until the Company received payments equal to two times the cash payment it made to Assertio, or
approximately $481.0 million, after which all net payments received by Assertio would have been shared equally between the
Company and Assertio. Following the amendment, the Assertio Royalty Agreement provides that the Company will receive all
royalty and milestone payments due under the license agreements between Assertio and its licensees. The Company has elected to
continue to follow the fair value option and carry the financial asset at fair value.
The Assertio Royalty Agreement terminates on the third anniversary following the date upon which the later of the following
occurs: (a) October 25, 2021, or (b) at such time as no royalty payments remain payable under any license agreement and each of
the license agreements has expired by its terms.
As of December 31, 2018, in conjunction with the amendment described above, the Company was provided the power to direct
the activities of Depo DR Sub, LLC and is the primary beneficiary of Depo DR Sub, LLC; therefore, Depo DR Sub, LLC is
subject to consolidation by the Company. As of December 31, 2019 and 2018, Depo DR Sub, LLC did not have any assets or
liabilities of value for consolidation with the Company.
The financial asset acquired represents a single unit of accounting. This financial asset is classified as a Level 3 asset within the
fair value hierarchy, as the Company’s valuation utilized significant unobservable inputs, including estimates as to the probability
and timing of future commercialization for products not yet approved by regulatory agencies outside of the United States. The
estimated fair value of the financial asset acquired was determined by using a discounted cash flow analysis related to the
expected future cash flows to be generated by each licensed product. The discounted cash flows are based upon expected royalties
from sales of licensed products over approximately a nine-year period. The estimated fair value of the asset is subject to variation
should those cash flows vary significantly from the Company’s estimates. The Company periodically assesses the expected future
cash flows and to the extent such payments are greater or less than its initial estimates, or the timing of such payments is
materially different than the original estimates, the Company will adjust the estimated fair value of the asset. A third-party expert
is engaged to assist management with the development of its estimate of the expected future cash flows, when deemed necessary.
Should the expected royalties increase or decrease by 2.5%, the fair value of the asset could increase or decrease by $5.5 million,
respectively. Significant judgment is required in selecting appropriate discount rates. The discount rates utilized range from 10%
to 24%. At December 31, 2019, an evaluation was performed to assess those rates and general market conditions potentially
64
affecting the fair market value of the financial asset. Should these discount rates increase or decrease by 2.5%, the fair value of
the asset could decrease by $17.5 million or increase by $20.5 million, respectively.
In February 2016, at the Company’s request and pursuant to the Assertio Royalty Agreement, Assertio exercised its audit right
with respect to Glumetza royalties. The independent auditor engaged to perform the royalty audit completed it in July 2017, and
based upon the results of the audit, Assertio, on behalf of the Company, filed a lawsuit on September 7, 2017, against Valeant and
one of its subsidiaries, claiming damages for unpaid royalties, fees and interest. Valeant (now Bausch Health), Assertio and the
Company entered into a settlement agreement on October 27, 2017 whereby the parties agreed to dismiss the litigation, with
prejudice, and Valeant agreed to pay to Assertio $13.0 million. The full amount of the settlement payment was transferred to the
Company under the terms of the Assertio Royalty Agreement in November 2017. In October 2018, PDL submitted notice of its
intent to exercise its audit right under the Assertio Royalty Agreement with respect to the period beginning January 1, 2016 and
ending December 31, 2018. No material adjustments were identified in connection with this audit.
As of December 31, 2019, the Company’s discounted cash flow analysis reflects its expectations as to the amount and timing of
future cash flows up to the valuation date for the above described royalty streams.
On May 31, 2016, the Company obtained a notification indicating that the FDA approved Jentadueto XR for use in patients with
Type 2 diabetes. In June 2016, the Company received a $6.0 million FDA approval milestone pursuant to the terms of the Assertio
Royalty Agreement. The product approval was earlier than initially expected. Based on the FDA approval and anticipated timing
of the product launch, the Company adjusted the timing of future cash flows and discount rate used in the discounted cash flow
model at June 30, 2016. At year-end 2017, management re-evaluated, with assistance of a third-party expert, the cash flow
assumptions for Jentadueto XR and revised the discounted cash flow model. As of December 31, 2019, the Company’s discounted
cash flow analysis reflects its expectations as to the amount and timing of future cash flows up to the valuation date.
On September 21, 2016, the Company obtained a notification indicating that the FDA approved Invokamet XR for use in patients
with Type 2 diabetes. The product approval triggered a $5.0 million approval milestone payment to the Company pursuant to the
terms of the Assertio Royalty Agreement. Based on the FDA approval and timing of the product launch, the Company adjusted
the timing of future cash flows and discount rate used in the discounted cash flow model at December 31, 2017.
On December 13, 2016, the Company obtained a notification indicating that the FDA approved Synjardy XR for use in patients
with Type 2 diabetes. The product approval triggered a $6.0 million approval milestone payment to the Company pursuant to the
terms of the Assertio Royalty Agreement. Based on the FDA approval and the April 2017 launch of Synjardy XR by Boehringer
Ingelheim, the Company adjusted the timing of future cash flows and discount rate used in the discounted cash flow model at
December 31, 2017.
In the fourth quarter of 2019, management re-evaluated, with assistance of a third-party expert, the market share data, the gross-
to-net revenue adjustment assumptions and Glumetza demand data and re-evaluated the assumptions, including the expected ex-
U.S. launch dates, underlying the fair values of the non-Glumetza Type 2 extended release diabetes products comprising the
Assertio royalty asset portfolio. These data and assumptions are based on available but limited information. Key findings from the
third-party study included: an anticipated decrease in the Glumetza net sales forecast due to an accelerated shift in the channel
mix resulting in a substantial decline in net selling prices, particularly in the fourth quarter of 2019 and beyond, as previously
announced by Bausch Health, and the delayed launch dates of the extended release products in the Assertio royalty asset portfolio
outside of the United States. As a result of this analysis, the Company wrote down the fair value of the Assertio asset by $46.3
million.
As of December 31, 2019, the fair value of the asset acquired as reported in Assets held for sale on the Company’s Consolidated
Balance Sheet was $218.7 million and the maximum loss exposure was $218.7 million.
Viscogliosi Brothers Royalty Agreement
On June 26, 2014, the Company entered into a Royalty Purchase and Sale Agreement (the “VB Royalty Agreement”) with
Viscogliosi Brothers, LLC (“VB”), whereby VB conveyed to the Company the right to receive royalties payable on sales of a
spinal implant that has received pre-market approval from the FDA held by VB and commercialized by Paradigm Spine, LLC
(“Paradigm Spine”), in exchange for a $15.5 million cash payment, less fees. Paradigm Spine was acquired in March 2019 by RTI
Surgical Holdings, Inc.
The royalty rights acquired include royalties accruing from and after April 1, 2014. Under the terms of the VB Royalty
Agreement, the Company receives all royalty payments due to VB pursuant to certain technology transfer agreements between
65
VB and Paradigm Spine until the Company has received payments equal to 2.3 times the cash payment made to VB, after which
all rights to receive royalties will be returned to VB. VB’s ability to repurchase the royalty right for a specified amount expired on
June 26, 2018.
The estimated fair value of the royalty rights at December 31, 2019, was determined by using a discounted cash flow analysis
related to the expected future cash flows to be received. This asset is classified as a Level 3 asset, as the Company’s valuation
utilized significant unobservable inputs, including estimates as to the probability and timing of future sales of the licensed
product. The discounted cash flow was based upon expected royalties from sales of licensed product over approximately a ten-
year period. The estimated fair value of the asset is subject to variation should those cash flows vary significantly from the
Company’s estimates. The Company periodically assesses the expected future cash flows and to the extent such payments are
greater or less than its initial estimates, or the timing of such payments is materially different than the original estimates, the
Company will adjust the estimated fair value of the asset. A third-party expert is engaged to assist management with the
development of its estimate of the expected future cash flows, when deemed necessary. Should the expected royalties increase or
decrease by 2.5%, the fair value of the asset could increase or decrease by $0.3 million, respectively. Significant judgment is
required in selecting the appropriate discount rate. The discount rate utilized was 15.0%. Should this discount rate increase or
decrease by 2.5%, the fair value of this asset could decrease by $1.3 million or increase by $1.6 million, respectively.
As of December 31, 2019, the Company’s discounted cash flow analysis reflects its expectations as to the amount and timing of
future cash flows up to the valuation date.
As of December 31, 2019, the fair value of the asset acquired as reported in Assets held for sale on the Company’s Consolidated
Balance Sheet was $13.6 million and the maximum loss exposure was $13.6 million.
University of Michigan Royalty Agreement
On November 6, 2014, the Company acquired a portion of all royalty payments of the U-M worldwide royalty interest in
Cerdelga® (eliglustat) for $65.6 million pursuant to the Royalty Purchase and Sale Agreement with U-M (the “U-M Royalty
Agreement”). Under the terms of the U-M Royalty Agreement, the Company receives 75% of all royalty payments due under the
U-M license agreement with Genzyme Corporation, a Sanofi company (“Genzyme”), until expiration of the licensed patents,
excluding any patent term extension. Cerdelga, an oral therapy for adult patients with Gaucher disease type 1, was developed by
Genzyme. Cerdelga was approved in the United States in August 2014, in the EU in January 2015, and in Japan in March 2015. In
addition, marketing applications for Cerdelga are under review by other regulatory authorities. While marketing applications have
been approved in the United States, the EU and Japan, national pricing and reimbursement decisions are delayed in some
countries.
The estimated fair value of the royalty right at December 31, 2019, was determined by using a discounted cash flow analysis
related to the expected future cash flows to be received. This asset is classified as a Level 3 asset, as the Company’s valuation
utilized significant unobservable inputs, including estimates as to the probability and timing of future sales of the licensed
product. The discounted cash flow was based upon expected royalties from sales of licensed product over approximately a three-
year period. Based on the results of the Company’s analysis, which considered input from a third-party expert and the variance
between the Company’s forecast model and actual results, the Company wrote down the fair value of the royalty asset by $3.1
million in the third quarter ended September 30, 2019. The estimated fair value of the asset is subject to variation should those
cash flows vary significantly from the Company’s estimates. An evaluation of those estimates, discount rate utilized and general
market conditions affecting fair market value is performed in each reporting period. A third-party expert is engaged to assist
management with the development of its estimate of the expected future cash flows, when deemed necessary. Should the expected
royalties increase or decrease by 2.5%, the fair value of the asset could increase or decrease by $0.5 million, respectively.
Significant judgment is required in selecting the appropriate discount rate. The discount rate utilized was approximately 12.8%.
Should this discount rate increase or decrease by 2.5%, the fair value of this asset could decrease or increase by $0.6 million. As
of December 31, 2019, the Company’s discounted cash flow analysis reflects its expectations as to the amount and timing of
future cash flows.
As of December 31, 2019, the fair value of the asset acquired as reported in Assets held for sale on the Company’s Consolidated
Balance Sheet was $20.4 million and the maximum loss exposure was $20.4 million.
ARIAD Royalty Agreement
On July 28, 2015, the Company entered into the revenue interest assignment agreement (the “ARIAD Royalty Agreement”) with
ARIAD, whereby the Company acquired the rights to receive royalties from ARIAD’s net revenues generated by the sale,
66
distribution or other use of Iclusig® (ponatinib), a cancer medicine for the treatment of adult patients with chronic myeloid
leukemia, in exchange for up to $200.0 million in cash payments. The purchase price of $100.0 million was payable in two
tranches of $50.0 million each, with the first tranche having been funded on July 28, 2015 and the second tranche having been
funded on July 28, 2016. Upon the occurrence of certain events, including a change of control of ARIAD, the Company had the
right to require ARIAD to repurchase the royalty rights for a specified amount. The Company elected the fair value option to
account for the hybrid instrument in its entirety. Any embedded derivative shall not be separated from the host contract. The asset
acquired pursuant to the ARIAD Royalty Agreement represents a single unit of accounting.
In February 2017, Takeda Pharmaceutical Company Limited (“Takeda”) acquired ARIAD and the Company exercised its put
option on the same day, which resulted in an obligation by Takeda to pay the Company a 1.2x multiple of the $100.0 million
funded by the Company under the ARIAD Royalty Agreement, less royalty payments already received by the Company.
On March 30, 2017, Takeda fulfilled its obligations under the put option and paid the Company the repurchase price of $108.2
million for the royalty rights under the ARIAD Royalty Agreement.
AcelRx Royalty Agreement
On September 18, 2015, the Company entered into a royalty interest assignment agreement (the “AcelRx Royalty Agreement”)
with ARPI LLC, a wholly-owned subsidiary of AcelRx Pharmaceuticals, Inc. (“AcelRx”), whereby the Company acquired the
rights to receive a portion of the royalties and certain milestone payments on sales of Zalviso® (sufentanil sublingual tablet
system) in the EU, Switzerland and Australia by AcelRx’s commercial partner, Grünenthal, in exchange for a $65.0 million cash
payment. Under the terms of the AcelRx Royalty Agreement, the Company receives 75% of all royalty payments and 80% of the
first four commercial milestone payments due under AcelRx’s license agreement with Grünenthal until the earlier to occur of (i)
receipt by the Company of payments equal to three times the cash payments made to AcelRx and (ii) the expiration of the licensed
patents. Zalviso received marketing approval by the European Commission in September 2015. Grünenthal launched Zalviso in
the second quarter of 2016 and the Company started to receive royalties in the third quarter of 2016.
As of December 31, 2019 and 2018, the Company determined that its royalty rights under the AcelRx Royalty Agreement
represented a variable interest in a variable interest entity. However, the Company does not have the power to direct the activities
of ARPI LLC that most significantly impact ARPI LLC’s economic performance and is not the primary beneficiary of ARPI LLC;
therefore, ARPI LLC is not subject to consolidation by the Company.
Due to the slower than expected adoption of the product since its initial launch relative to the Company’s estimates and the
increased variance noted between the Company’s forecast model and actual results in the three months ended June 30, 2019, the
Company utilized a third-party expert in the second quarter of 2019 to reassess the market and expectations for the Zalviso
product. Key findings from the third-party study included: the post-surgical PCA (Patient-Controlled Analgesia) market being
smaller than previously forecasted; the higher price of the product relative to alternative therapies, the product not being used as a
replacement for systemic opioids and the design of the delivery device, which is pre-filled for up to three days of treatment, which
limited its use for procedures with anticipated shorter recovery times. Based on this analysis and the impact to the projected sales-
based royalties and milestones, the Company wrote down the fair value of the royalty asset by $60.0 million in the second quarter
of 2019.
The estimated fair value of the royalty right at December 31, 2019, was determined by using a discounted cash flow analysis
related to the expected future cash flows to be received. This asset is classified as a Level 3 asset, as the Company’s valuation
utilized significant unobservable inputs, including estimates as to the probability and timing of future sales of the licensed
product. The discounted cash flow was based upon expected royalties from sales of licensed product over approximately a
thirteen-year period. The estimated fair value of the asset is subject to variation should those cash flows vary significantly from
the Company’s estimates. An evaluation of those estimates, discount rate utilized and general market conditions affecting fair
market valuation is performed for each reporting period. A third-party expert is engaged to assist management with the
development of its estimate of the expected future cash flows, when deemed necessary. Should the expected royalties increase or
decrease by 2.5%, the fair value of the asset could increase or decrease by $0.3 million, respectively. Significant judgment is
required in selecting the appropriate discount rate. The discount rate utilized was approximately 13.4%. Should this discount rate
increase or decrease by 2.5%, the fair value of this asset could decrease by $1.2 million or increase by $1.4 million, respectively.
As of December 31, 2019, the Company’s discounted cash flow analysis reflects its expectations as to the amount and timing of
future cash flows up to the valuation date.
As of December 31, 2019, the fair value of the asset acquired as reported in Assets held for sale on the Company’s Consolidated
Balance Sheet was $13.0 million and the maximum loss exposure was $13.0 million.
67
Kybella Royalty Agreement
On July 8, 2016, the Company entered into a royalty purchase and sales agreement with an individual, whereby the Company
acquired that individual’s rights to receive certain royalties on sales of KYBELLA® by Allergan plc in exchange for a $9.5 million
cash payment and up to $1.0 million in future milestone payments based upon product sales targets. The Company started to
receive royalty payments during the third quarter of 2016.
The estimated fair value of the royalty right at December 31, 2019, was determined by using a discounted cash flow analysis
related to the expected future cash flows to be received. This asset is classified as a Level 3 asset, as the Company’s valuation
utilized significant unobservable inputs, including estimates as to the probability and timing of future sales of the licensed
product. The discounted cash flow was based upon expected royalties from sales of a licensed product over approximately a six-
year period. The estimated fair value of the asset is subject to variation should those cash flows vary significantly from the
Company’s estimates. An evaluation of those estimates, discount rate utilized and general market conditions affecting fair market
value is performed in each reporting period. A third-party expert is engaged to assist management with the development of its
estimate of the expected future cash flows, when deemed necessary. Should the expected royalties increase or decrease by 2.5%,
the fair value of the asset could increase or decrease by less than $0.1 million, respectively. Significant judgment is required in
selecting the appropriate discount rate. The discount rate utilized was approximately 14.4%. Should this discount rate increase or
decrease by 2.5%, the fair value of this asset could decrease or increase by less than $0.1 million, respectively.
As of December 31, 2019, the Company’s discounted cash flow analysis reflects its expectations as to the amount and timing of
future cash flows up to the valuation date.
As of December 31, 2019, the fair value of the asset acquired as reported in Assets held for sale on the Company’s Consolidated
Balance Sheet was $0.6 million and the maximum loss exposure was $0.6 million.
The following tables summarize the changes in Level 3 Royalty Right Assets and the gains and losses included in earnings for the
year ended December 31, 2019:
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) - Royalty Rights Assets
(in thousands)
Royalty Rights
- At Fair Value
Fair value as of December 31, 2018.........................................................................................................
$
376,510
Total net change in fair value for the period
Change in fair value of royalty rights - at fair value............................................................
Proceeds from royalty rights - at fair value .........................................................................
Total net change in fair value for the period ..............................................................
$ (31,042)
$ (79,272)
(110,314)
Fair value as of December 31, 2019.........................................................................................................
$
266,196
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) - Royalty Rights Assets
(in thousands)
Assertio........................................................................................
VB ...............................................................................................
U-M .............................................................................................
AcelRx.........................................................................................
KYBELLA ..................................................................................
Fair Value as of
Royalty Rights -
December 31, 2018 Change in Fair Value December 31, 2019
218,672
$
Fair Value as of
(45,699) $
264,371
$
14,108
25,595
70,380
2,056
(518)
(5,197)
(57,428)
(1,472)
$
376,510
$
(110,314) $
13,590
20,398
12,952
584
266,196
68
The following table summarizes the changes in Level 3 liabilities and the gains and losses included in earnings for the year ended
December 31, 2019:
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) - Liabilities
(in thousands)
Contingent
Consideration
Fair value as of December 31, 2018 .......................................................................................................................
$
(1,071)
Settlement of financial instrument 1 ...............................................................................................................
1,071
Fair value as of December 31, 2019 .......................................................................................................................
$
—
___________________
1 Represents the final conversion consideration and earn out liability for the LENSAR acquisition of assets from
Precision Eye Services (“PES”).
Gains and losses from changes in Level 3 assets included in earnings for each period are presented in “Royalty rights - change in
fair value” and gains and losses from changes in Level 3 liabilities included in earnings for each period are presented in “Change
in fair value of anniversary payment and contingent consideration” as follows:
(in thousands)
Total change in fair value for the period included in earnings for royalty right assets
held at the end of the reporting period ..............................................................................
Total change in fair value for the period included in earnings for liabilities held at the
end of the reporting period................................................................................................
Assets/Liabilities Measured and Recorded at Fair Value on a Nonrecurring Basis
Year Ended December 31,
2019
2018
$
$
(31,042) $
85,256
— $
41,631
The Company remeasures the fair value of certain assets and liabilities upon the occurrence of certain events. Such assets consist
of long-lived assets, including property and equipment and intangible assets and the shares of Alphaeon Class A common stock,
received in connection with the loans made to LENSAR by the Company prior to its acquisition of LENSAR.
During the year ended December 31, 2019, the Company recorded an impairment charge of $22.5 million for the Noden
intangible assets given the Company’s monetization strategy and updated forecasts for Noden. As a result of this impairment
charge, which was based on the estimated fair value of the assets, the remaining carrying value of these intangible assets was
determined to be $10.1 million. During the three months ended June 30, 2018, the Company recorded an impairment charge of
$152.3 million for the Noden intangible assets related to the increased probability of a generic form of aliskiren being launched in
the United States. As a result of this impairment charge, which was based on the estimated fair value of the assets, the remaining
carrying value of these intangible assets was determined to be $40.1 million. These intangible asset fair value calculations
included level 3 inputs. For additional information on the Noden intangible asset, see Note 11, Intangible Assets.
The Company’s carrying value of the 1.7 million shares of Alphaeon common stock as of both December 31, 2019 and December
31, 2018 is $6.6 million based on an estimated per share value of $3.84, which was established by a valuation performed when the
shares were acquired. The value of the Company’s investment in Alphaeon is not readily determinable as Alphaeon’s shares are
not publicly traded. The Company evaluates the fair value of this investment by performing a qualitative assessment each
reporting period. If the results of this qualitative assessment indicate that the fair value is less than the carrying value, the
investment is written down to its fair value. There have been no such write downs since the Company acquired these shares. This
investment is included in Other long-term assets. For additional information on the Alphaeon investment, see Note 8, Notes and
Other Long-Term Receivables.
69
Assets/Liabilities Not Subject to Fair Value Recognition
The following tables present the fair value of assets and liabilities not subject to fair value recognition by level within the
valuation hierarchy:
(in thousands)
Assets:
Wellstat Diagnostics note receivable ........
Hyperion note receivable ..........................
CareView note receivable .........................
Total......................................................
Liabilities:
December 2021 Notes ...............................
December 2024 Notes ...............................
Total......................................................
December 31, 2019
Fair Value
Level 2
Carrying
Value
Fair Value
Level 3
Carrying
Value
December 31, 2018
Fair Value
Level 2
Fair Value
Level 3
$
50,191
$
— $
55,389
$
50,191
$
— $
57,322
1,200
690
52,081
16,950
10,300
27,250
$
$
$
$
$
$
—
—
— $
1,200
690
57,279
$
1,200
11,458
62,849
$
—
—
— $
1,200
11,458
69,980
20,978
12,953
33,931
$
$
— $ 124,644
$ 151,356
—
—
—
— $ 124,644
$ 151,356
$
$
—
—
—
During the years ended December 31, 2019 and 2018 the Company recorded impairment losses of $10.8 million and $8.2 million,
respectively, for the note receivable with CareView. There were no impairment losses on notes receivable in the year ended
December 31, 2017.
As of December 31, 2019 the estimated fair value of the CareView note receivable was determined using a liquidation analysis. A
liquidation analysis considers the asset side of the balance sheet and adjusts the value in accordance with the relative risk
associated with the asset and the probable liquidation value. The asset recovery rates varied by asset. At December 31, 2018, the
estimated fair value of the CareView note receivable was determined using discounted cash flow models, using a discount rate of
30%, incorporating expected principal and interest payments and also considered the recoverability of the note receivable balance
utilizing third-party revenue multiples for small cap healthcare technology companies. As of December 31, 2019 and 2018, the
estimated fair value of the Wellstat Diagnostics and Hyperion Catalysis International, Inc. (“Hyperion”) notes receivable were
determined by using an asset approach and discounted cash flow model related to the underlying collateral and adjusted to
consider estimated costs to sell the assets.
The Company determined its notes receivable assets are Level 3 assets as the Company’s valuations utilized significant
unobservable inputs, including estimates of future revenues, discount rates, expectations about settlement, terminal values,
required yield and the value of underlying collateral. The Company engages third-party valuation experts when deemed necessary
to assist in evaluating its investments and the related inputs needed to estimate the fair value of certain investments.
The CareView note receivable is secured by substantially all assets of, and equity interests in, CareView. The Wellstat Diagnostics
note receivable is secured by substantially all assets of Wellstat Diagnostics and is supported by a guaranty from the Wellstat
Diagnostics Guarantors (as defined in Note 8, Notes and Other Long-Term Receivables).
On December 31, 2019, the carrying value of one of the Company’s notes receivable assets differed from its estimated fair value.
This is the result of inputs used in estimating the fair value of the collateral, including appraisals, projected cash flows of
collateral assets and discount rates used when performing a discounted cash flow analysis.
The fair values of the Company’s convertible senior notes were determined using quoted market pricing.
70
The following table represents significant unobservable inputs used in determining the estimated fair value of the Wellstat
Diagnostics note receivable investment:
Asset
Valuation
Technique
Unobservable
Input
December 31,
2019
December 31,
2018
Wellstat Diagnostics
Wellstat Diagnostics Guarantors
intellectual property....................
Income Approach
Settlement Amount ......................
Income Approach
Real Estate Property................... Market Approach
Discount rate .................................
Undiscounted royalty amount .......
12%
$21 million
12%
$21 million
Discount rate .................................
Undiscounted settlement amount ..
15%
$28 million
15%
$34 million
Estimated annual appreciation ......
Estimated realtor fee .....................
Undiscounted market value...........
—%
6%
$16 million
4%
6%
$16 million
8. Notes and Other Long-Term Receivables
Notes and other long-term receivables included the following significant agreements:
Wellstat Diagnostics Note Receivable and Credit Agreement and Related Litigation
On November 2, 2012, the Company and Wellstat Diagnostics entered into a $40.0 million credit agreement pursuant to which the
Company was to accrue quarterly interest payments at the rate of 5% per annum (payable in cash or in kind). In addition, the
Company was to receive quarterly royalty payments based on a low double-digit royalty rate of Wellstat Diagnostics’ net
revenues, generated by the sale, distribution or other use of Wellstat Diagnostics’ products, if any, commencing upon the
commercialization of its products. A portion of the proceeds of the $40.0 million credit agreement were used to repay certain
notes receivable which Wellstat Diagnostics entered into in March 2012.
In January 2013, the Company was informed that, as of December 31, 2012, Wellstat Diagnostics had used funds contrary to the
terms of the credit agreement and breached Sections 2.1.2 and 7 of the credit agreement. The Company sent Wellstat Diagnostics
a notice of default on January 22, 2013, and accelerated the amounts owed under the credit agreement. In connection with the
notice of default, the Company exercised one of its available remedies and transferred approximately $8.1 million of available
cash from a bank account of Wellstat Diagnostics to the Company and applied the funds to amounts due under the credit
agreement. On February 28, 2013, the parties entered into a forbearance agreement whereby the Company agreed to refrain from
exercising additional remedies for 120 days. During such forbearance period, the Company provided approximately $1.3 million
to Wellstat Diagnostics to fund ongoing operations of the business. During the year ended December 31, 2013, approximately
$8.7 million was advanced pursuant to the forbearance agreement.
On August 15, 2013, the Company entered into an amended and restated credit agreement with Wellstat Diagnostics. The
Company determined that the new agreement should be accounted for as a modification of the existing agreement.
Except as otherwise described herein, the material terms of the amended and restated credit agreement are substantially the same
as those of the original credit agreement, including quarterly interest payments at the rate of 5% per annum (payable in cash or in
kind). In addition, the Company was to continue to receive quarterly royalty payments based on a low double-digit royalty rate of
Wellstat Diagnostics’ net revenues. However, pursuant to the amended and restated credit agreement: (i) the principal amount was
reset to approximately $44.1 million, which was comprised of approximately $33.7 million original loan principal and interest,
$1.3 million term loan principal and interest and $9.1 million forbearance principal and interest; (ii) the specified internal rates of
return increased; (iii) the default interest rate was increased; (iv) Wellstat Diagnostics’ obligation to provide certain financial
information increased in frequency to monthly; (v) internal financial controls were strengthened by requiring Wellstat Diagnostics
to maintain an independent, third-party financial professional with control over fund disbursements; (vi) the Company waived the
existing events of default; and (vii) the owners and affiliates of Wellstat Diagnostics were required to contribute additional capital
to Wellstat Diagnostics upon the sale of an affiliate entity. The amended and restated credit agreement had an ultimate maturity
date of December 31, 2021 (but has subsequently been accelerated as described below).
71
In June 2014, the Company received information from Wellstat Diagnostics showing that it was generally unable to pay its debts
as they became due, constituting an event of default under the amended and restated credit agreement.
On August 5, 2014, the Company delivered a notice of default to Wellstat Diagnostics, which accelerated all obligations under the
amended and restated credit agreement and demanded immediate payment in full in an amount equal to approximately $53.9
million, (which amount, in accordance with the terms of the amended and restated credit agreement, included an amount that,
together with interest and royalty payments already made to the Company, would generate a specified internal rate of return to the
Company), plus accruing fees, costs and interest, and demanded that Wellstat Diagnostics protect and preserve all collateral
securing its obligations.
On August 7, 2014, the Company delivered a notice to each of the guarantors of Wellstat Diagnostics’ obligations to the Company
(collectively, the “Wellstat Diagnostics Guarantors”) under the credit agreement, which included a demand that the guarantors
remit payment to the Company in the amount of the outstanding obligations. The guarantors include certain affiliates and related
companies of Wellstat Diagnostics, including Wellstat Therapeutics and Wellstat Diagnostics’ stockholders.
On September 24, 2014, the Company filed an ex-parte petition for appointment of receiver with the Circuit Court of
Montgomery County, Maryland, which was granted on the same day. Wellstat Diagnostics remained in operation during the
period of the receivership with incremental additional funding from the Company. On May 24, 2017, Wellstat Diagnostics
transferred substantially all of its assets to the Company pursuant to a credit bid. The credit bid reduced the outstanding balance of
the loan by an immaterial amount.
On September 4, 2015, the Company filed in the Supreme Court of New York a motion for summary judgment in lieu of
complaint which requested that the court enter judgment against certain of the Wellstat Diagnostics Guarantors for the total
amount due on the Wellstat Diagnostics debt, plus all costs and expenses including lawyers’ fees incurred by the Company in
enforcement of the related guarantees. On September 23, 2015, the Company filed in the same court an ex parte application for a
temporary restraining order and order of attachment of the Wellstat Diagnostics Guarantor defendants’ assets. Although the court
denied the Company’s request for a temporary restraining order at a hearing on September 24, 2015, it ordered that assets of the
Wellstat Diagnostics Guarantor defendants should be held in status quo ante and only used in the normal course of business.
On July 29, 2016, the Supreme Court of New York granted the Company’s motion for summary judgment and held that the
Wellstat Diagnostics Guarantor defendants are liable for all “Obligations” owed by Wellstat Diagnostics to the Company.
After appeal by the Wellstat Diagnostics Guarantor defendants on February 14, 2017, the Appellate Division of the Supreme
Court of New York reversed on procedural grounds a portion of the Memorandum of Decision granting the Company summary
judgment in lieu of complaint, but affirmed the portion of the Memorandum of Decision denying the Wellstat Diagnostics
Guarantor defendants’ motion for summary judgment in which they sought a determination that the guarantees had been released.
As a result, the litigation has been remanded to the Supreme Court of New York to proceed on the Company’s claims as a plenary
action. On June 21, 2017, the Supreme Court of New York ordered the Company to file a Complaint, which was filed by the
Company on July 20, 2017. The Wellstat Diagnostics Guarantors filed their answer on August 9, 2017, including counterclaims
against the Company alleging breach of contract, breach of fiduciary duty, and tortious interference with prospective economic
advantage.
On October 14, 2016, the Company sent a notice of default and reference to foreclosure proceedings to certain of the Wellstat
Diagnostics Guarantors which are not defendants in the New York action, but which are owners of real estate assets over which a
deed of trust in favor of the Company securing the guarantee of the loan to Wellstat Diagnostics had been executed. On March 2,
2017, the Company sent a second notice to foreclose on the real estate assets, and noticed the sale for March 29, 2017. The sale
was taken off the calendar by the trustee under the deed of trust and has not been re-scheduled yet. On March 6, 2017, the
Company sent a letter to the Wellstat Diagnostics Guarantors seeking information in preparation for a UCC Article 9 sale of some
or all of the intellectual property-related collateral of the Wellstat Diagnostics Guarantors. The Wellstat Diagnostics Guarantors
did not respond to the Company’s letter, but on March 17, 2017, filed an order to show cause with the Supreme Court of New
York to enjoin the Company’s sale of the real estate or enforcing its security interests in the Wellstat Diagnostics Guarantors’
intellectual property during the pendency of any action involving the guarantees at issue. On February 6, 2018, the Supreme Court
of New York issued an order from the bench which enjoins the Wellstat Diagnostics Guarantors from selling, encumbering,
removing, transferring or altering the collateral pending the outcome of the proceedings before it. The Supreme Court of New
York also issued an order precluding the Company from foreclosing on certain of the Wellstat Diagnostics Guarantors’ collateral
pending the outcome of the proceedings before it. In September of 2018, discovery in the New York action was completed.
Summary judgment motions were filed by Wellstat Diagnostics and the Company in 2018 and a hearing was held on May 22,
72
2019. On September 11, 2019, the Supreme Court of New York granted the Company’s summary judgment motion, the court
holding that the guarantees executed by the Wellstat Diagnostics Guarantors are valid and enforceable, and that the Wellstat
Diagnostics Guarantors are liable for the amount owed under the loan agreement. The court ordered a damages inquest before a
special referee to calculate the amount owed under the loan agreement between Wellstat Diagnostics and the Company. On
September 12, 2019, the Wellstat Diagnostics Guarantors filed a notice of appeal in relation to the court’s decision. On September
17, 2019, the Wellstat Diagnostics Guarantors requested a stay of the enforcement of the New York Supreme Court’s decision
pending their appeal of the decision, which was denied on November 21, 2019. A damages hearing was scheduled to begin before
a judicial hearing officer on December 17, 2019. At the request of the judicial hearing officer, the parties agreed to mediate their
dispute prior to the commencement of the damages hearing. As a result, no decision has been made by the hearing officer with
respect to the amount of damages owed to the Company.
In an unrelated litigation, Wellstat Therapeutics filed a lawsuit against BTG International, Inc. for breach of contract (the “BTG
Litigation”). In September 2017, the Delaware Chancery Court found in favor of Wellstat Therapeutics and awarded a judgment
of $55.8 million in damages, plus interest. In October 2017, the Company filed a motion with the Supreme Court of New York
requesting a pre-judgement attachment of the award. In June 2018, the Delaware Supreme Court largely affirmed the September
2017 decision of the Delaware Chancery Court, including the $55.8 million awarded in judgment. In August of 2018, in a letter to
the Company’s counsel, Wellstat Diagnostics Guarantors’ counsel confirmed that the Wellstat Diagnostics Guarantors are
preserving the BTG Litigation judgment award proceeds consistent with the New York Court’s prior directions.
On October 22, 2015, certain of the Wellstat Diagnostics Guarantors filed a separate complaint against the Company in the
Supreme Court of New York seeking a declaratory judgment that certain contractual arrangements entered into between the
parties subsequent to Wellstat Diagnostics’ default, and which relate to a split of proceeds in the event that the Wellstat
Diagnostics Guarantors voluntarily monetize any assets that are the Company’s collateral, is of no force or effect. This case has
been joined for all purposes, including discovery and trial, and consolidated with the pending case filed by the Company. The
Wellstat Diagnostic Guarantors filed a summary judgment motion with regard to this case, which was also heard by the court at
the hearing on May 22, 2019. The court, in its September 11, 2019 decision, denied in its entirety the Wellstat Diagnostics
Guarantors’ motion for summary judgment.
Effective April 1, 2014, and as a result of the event of default, the Company determined the loan to be impaired and it ceased to
accrue interest revenue. At that time and as of December 31, 2019, it has been determined that an allowance on the carrying value
of the note was not necessary, as the Company believes the value of the collateral securing Wellstat Diagnostics’ obligations
exceeds the carrying value of the asset and is sufficient to enable the Company to recover the current carrying value of $50.2
million. The Company continues to closely monitor the timing and expected recovery of amounts due, including litigation and
other matters related to Wellstat Diagnostics Guarantors’ assets. There can be no assurance that an allowance on the carrying
value of the notes receivable investment will not be necessary in a future period depending on future developments.
Hyperion Agreement
On January 27, 2012, the Company and Hyperion (which is also a Wellstat Diagnostics Guarantor) entered into an agreement
whereby Hyperion sold to the Company the royalty streams accruing from January 1, 2012 through December 31, 2013 due from
Showa Denko K.K. (“SDK”) related to a certain patent license agreement between Hyperion and SDK dated December 31, 2008.
In exchange for the lump sum payment to Hyperion of $2.3 million, in addition to any royalties from SDK, the Company was to
receive two equal payments of $1.2 million on March 5, 2013 and March 5, 2014. The first payment of $1.2 million was paid on
March 5, 2013, but the second payment that was due on March 5, 2014 has not been made by Hyperion. Effective as of such date
and as a result of the event of default, the Company ceased to accrue interest revenue. As of December 31, 2019, the estimated
fair value of the collateral was determined to be in excess of the carrying value. There can be no assurance of realizing value from
such collateral in the event of the Company’s foreclosure on the collateral.
Avinger Credit and Royalty Agreement
On April 18, 2013, the Company entered into a credit agreement with Avinger, Inc. (the “Avinger Credit and Royalty
Agreement”). Under the terms of the Avinger Credit and Royalty Agreement, the Company received a low, single-digit royalty on
Avinger’s net revenues until April 2018. Commencing in October 2015, after Avinger repaid $21.4 million pursuant to its note
payable to the Company prior to its maturity date, the royalty on Avinger’s net revenues was reduced by 50%, subject to certain
minimum payments from the prepayment date until April 18, 2018. The Company accounted for the royalty rights in accordance
with the fair value option. As of April 18, 2018, there were no further obligations owed to the Company.
73
LENSAR Credit Agreement
On October 1, 2013, the Company entered into a credit agreement with LENSAR, pursuant to which the Company made available
to LENSAR up to $60.0 million to be used by LENSAR in connection with the commercialization of its currently marketed
LENSAR™ Laser System. Of the $60.0 million available to LENSAR, an initial $40.0 million, net of fees, was funded by the
Company at the close of the transaction. The remaining $20.0 million was never funded. Outstanding borrowings under the loans
bore interest at the rate of 15.5% per annum, payable quarterly in arrears.
On May 12, 2015, the Company entered into a forbearance agreement with LENSAR, pursuant to which the Company agreed to
refrain from exercising certain remedies available to it resulting from the failure of LENSAR to comply with a liquidity covenant
and make interest payments due under the credit agreement. Under the forbearance agreement, the Company agreed to provide
LENSAR with up to an aggregate of $8.5 million in weekly increments through the period ended September 30, 2015 plus
employee retention amounts of approximately $0.5 million in the form of additional loans, subject to LENSAR meeting certain
milestones related to LENSAR obtaining additional capital to fund or to sell the business and repay outstanding amounts under
the credit agreement. In exchange for the forbearance, LENSAR agreed to additional reporting covenants, the engagement of a
chief restructuring officer and an increase on the interest rate to 18.5%, applicable to all outstanding amounts under the credit
agreement.
On September 30, 2015, the Company agreed to extend the forbearance agreement until October 9, 2015 and provide for up to an
additional $0.8 million in funding while LENSAR negotiated a potential sale of its assets. On October 9, 2015, the forbearance
agreement expired, but the Company agreed to fund LENSAR’s operations while LENSAR continued to negotiate a potential sale
of its assets.
On November 15, 2015, LENSAR, LLC (“LENSAR/Alphaeon”), a wholly-owned subsidiary of Alphaeon, and LENSAR entered
into the Asset Purchase Agreement whereby LENSAR/Alphaeon agreed to acquire certain assets of LENSAR and assumed
certain liabilities of LENSAR. The acquisition was consummated on December 15, 2015.
In connection with the closing of the acquisition, LENSAR/Alphaeon entered into an amended and restated credit agreement with
the Company, assuming $42.0 million in loans as part of the borrowings under the Company’s prior credit agreement with
LENSAR. In addition, Alphaeon issued 1.7 million shares of its Class A common stock to the Company which were valued at
$6.6 million at the time the shares were received. For additional information on this investment in Alphaeon, see Note 7, Fair
Value Measurements.
In December 2016, LENSAR, re-acquired the assets from LENSAR/Alphaeon and the Company entered into a second amended
and restated credit agreement with LENSAR whereby LENSAR assumed all obligations under the amended and restated credit
agreement with LENSAR/Alphaeon. Also in December, LENSAR filed for a voluntary petition under Chapter 11 of the U.S.
Bankruptcy Code (“Chapter 11 case”) with the support of the Company. In January 2017, the Company agreed to provide debtor-
in-possession financing of up to $2.8 million in new advances to LENSAR so that it could continue to operate its business during
the Chapter 11 case. LENSAR filed a Chapter 11 plan of reorganization with the Company’s support under which LENSAR
would issue all of its equity interests to the Company in exchange for the cancellation of the Company’s claims as a secured
creditor in the Chapter 11 case, other than with respect to the debtor-in-possession financing, and would thereby become an
operating wholly-owned subsidiary of the Company. On April 26, 2017, the bankruptcy court approved the plan of reorganization.
Pursuant to the plan of reorganization, LENSAR emerged from bankruptcy on May 11, 2017 as a wholly-owned subsidiary of the
Company, and the Company started to consolidate LENSAR’s financial statements under the voting interest model beginning
May 11, 2017.
For additional information on LENSAR please refer to Note 11, Intangible Assets, Note 21, Segment Information and Note 25,
Business Combinations.
Direct Flow Medical Credit Agreement
On November 5, 2013, the Company entered into a credit agreement with Direct Flow Medical, Inc. (“Direct Flow Medical”)
under which the Company agreed to provide up to $50.0 million to Direct Flow Medical. Of the $50.0 million available to Direct
Flow Medical, the first tranche of $35.0 million, net of fees, was funded by the Company at the close of the transaction.
On November 10, 2014, the Company and Direct Flow Medical agreed to an amendment to the credit agreement to permit Direct
Flow Medical to borrow an additional $15.0 million (in a second tranche) upon receipt by Direct Flow Medical of a specified
74
minimum amount of proceeds from an equity offering prior to December 31, 2014. In exchange, the parties amended the credit
agreement to provide for additional fees associated with certain liquidity events, such as a change of control or the consummation
of an initial public offering, and granted the Company certain board of director observation rights. On November 19, 2014, upon
Direct Flow Medical satisfying the amended tranche two milestone, the Company funded the $15.0 million second tranche to
Direct Flow Medical, net of fees.
Outstanding borrowings under tranche one bore interest at the rate of 15.5% per annum, payable quarterly in arrears, until the
occurrence of the second tranche. Upon occurrence of the borrowing of this second tranche, the interest rate applicable to all loans
under the credit agreement was decreased to 13.5% per annum, payable quarterly in arrears.
Under the terms of the credit agreement, Direct Flow Medical’s obligation to repay loan principal commenced on the twelfth
interest payment date, September 30, 2016. The principal amount outstanding at commencement of repayment was required to be
repaid in equal installments until final maturity of the loans. The loans were scheduled to mature on November 5, 2018. The
obligations under the credit agreement were secured by a pledge of substantially all of the assets of Direct Flow Medical and any
of its subsidiaries.
On December 21, 2015, Direct Flow Medical and the Company entered into a waiver to the credit agreement in anticipation of
Direct Flow Medical being unable to comply with the liquidity covenant and make interest payments due under the credit
agreement, which was subsequently extended on January 14, 2016, and further delayed the timing of the interest payments
through the period ending September 30, 2016 while Direct Flow Medical sought additional financing to operate its business.
On January 28, 2016, the Company funded an additional $5.0 million to Direct Flow Medical in the form of a short-term secured
promissory note.
On February 26, 2016, the Company and Direct Flow Medical entered into the fourth amendment to the credit agreement that,
among other things, (i) converted the $5.0 million short-term secured promissory note into a loan under the credit agreement with
substantially the same interest and payment terms as the existing loans, (ii) added a conversion feature whereby the $5.0 million
loan would convert into equity of Direct Flow Medical upon the occurrence of certain events and (iii) provided for a second $5.0
million convertible loan tranche commitment, to be funded at the option of the Company. The commitment for the second tranche
was not funded and has since expired. In addition, (i) the Company agreed to waive the liquidity covenant and delay the timing of
the unpaid interest payments until September 30, 2016 and (ii) Direct Flow Medical agreed to issue to the Company a specified
amount of warrants to purchase shares of convertible preferred stock on the first day of each month for the duration of the waiver
period at an exercise price of $0.01 per share.
On July 15, 2016, the Company and Direct Flow Medical entered into the fifth amendment and limited waiver to the credit
agreement. The Company funded an additional $1.5 million to Direct Flow Medical in the form of a note with substantially the
same interest and payment terms as the existing loans and a conversion feature whereby the $1.5 million loan would convert into
equity of Direct Flow Medical upon the occurrence of certain events. In addition, Direct Flow Medical agreed to issue to the
Company warrants to purchase shares of convertible preferred stock at an exercise price of $0.01 per share.
On September 12, 2016, the Company and Direct Flow Medical entered into the sixth amendment and limited waiver to the credit
agreement under which the Company funded an additional $1.5 million to Direct Flow Medical in the form of a note with
substantially the same interest and payment terms as the existing loans. In addition, Direct Flow Medical agreed to issue to the
Company a specified amount of warrants to purchase shares of convertible preferred stock at an exercise price of $0.01 per share.
On September 30, 2016, the Company and Direct Flow Medical entered into a waiver to the credit agreement where the parties
agreed, among other things, to (i) delay payment on all overdue interest payments until October 31, 2016, (ii) waive the initial
principal repayment until October 31, 2016 and (iii) continue to waive the liquidity requirements until October 31, 2016. Further,
Direct Flow Medical agreed to issue to the Company a specified amount of warrants to purchase shares of convertible preferred
stock at an exercise price of $0.01 per share.
On October 31, 2016, the Company agreed to extend the waivers described above until November 30, 2016 and on November 14,
2016, the Company advanced an additional $1.0 million loan while Direct Flow Medical continued to seek additional financing.
On November 16, 2016, Direct Flow Medical advised the Company that its potential financing source had modified its proposal
from an equity investment to a loan with a substantially smaller amount and under less favorable terms. Direct Flow Medical shut
down its operations in December 2016 and in January 2017 made an assignment for the benefit of creditors. The Company then
initiated foreclosure proceedings, resulting in the Company obtaining ownership of most of the Direct Flow Medical assets
75
through the Company’s wholly-owned subsidiary, DFM, LLC. The assets were held for sale and carried at the lower of carrying
amount or fair value, less estimated selling costs, which was primarily based on supporting data from market participant sources,
and valid offers from third parties.
At December 31, 2016, the Company completed an impairment analysis and concluded that the situation qualified as a troubled
debt restructuring and recognized an impairment loss of $51.1 million.
In January 2017, the Company started to actively market the asset held for sale. On January 23, 2017, the Company and DFM,
LLC entered into an Intellectual Property Assignment Agreement with Hong Kong Haisco Pharmaceutical Co., Limited
(“Haisco”), a Chinese pharmaceutical company, whereby Haisco acquired former Direct Flow Medical clinical, regulatory and
commercial information and intellectual property rights exclusively in China for $7.0 million. The Company, through DFM, LLC,
also sold Haisco certain manufacturing equipment for $450,000 and collected $692,000 on outstanding Direct Flow Medical
accounts receivable during the year ended December 31, 2017.
On January 6, 2018, DFM, LLC, a wholly-owned subsidiary of the Company, and HaisThera Advisors Co., Limited
(“HaisThera”) entered into a license agreement whereby DFM, LLC granted HaisThera an exclusive license to develop,
manufacture and commercialize percutaneously implanting stentless aortic valves in the EU. The consideration for the license
agreement was $500,000 upfront and up to $2.0 million in royalty payments. In August 2019, the remaining assets of DFM, LLC
were sold for $5.0 million.
kaléo Note Purchase Agreement
On April 1, 2014, the Company entered into a note purchase agreement with Accel 300, LLC (“Accel 300”), a wholly-owned
subsidiary of kaléo, Inc. (“kaléo”), pursuant to which the Company acquired $150.0 million of secured notes due 2029 (the “kaléo
Note”). The kaléo Note was issued pursuant to an indenture between Accel 300 and U.S. Bank, National Association, as trustee,
and was secured by 20% of net sales of its first approved product, Auvi-Q® (epinephrine auto-injection, USP) (known as
Allerject® in Canada) and 10% of net sales of kaléo’s second proprietary auto-injector based product, EVZIO (naloxone
hydrochloride injection ) (the “kaléo Revenue Interests”), and a pledge of kaléo’s equity ownership in Accel 300.
On September 21, 2017, the Company entered into an agreement (the “kaléo Note Sale Agreement”) with MAM-Kangaroo
Lender, LLC, a Delaware limited liability company (the “kaléo Purchaser”), pursuant to which the Company sold its entire
interest in the kaléo Note.
Pursuant to the kaléo Note Sale Agreement, the kaléo Purchaser paid to the Company an amount equal to all of the then
outstanding principal, a premium of 1% of such amount and accrued interest under the kaléo Note, for an aggregate cash purchase
price of $141.7 million, subject to an 18-month escrow holdback of $1.4 million against certain potential contingencies. The
escrow period ended on March 20, 2019 and the escrow agent released the entire $1.4 million to the Company. For a further
discussion on this topic, see Note 16, Commitments and Contingencies.
CareView Credit Agreement
On June 26, 2015, the Company entered into a credit agreement with CareView, under which the Company made available to
CareView up to $40.0 million in loans comprised of two tranches of $20.0 million each, subject to CareView’s attainment of
specified milestones relating to the placement of CareView Systems. On October 7, 2015, the Company and CareView entered
into an amendment of the credit agreement to modify certain definitions related to the first and second tranche milestones and the
Company funded the first tranche of $20.0 million, net of fees, based on CareView’s attainment of the first milestone, as
amended. The second $20.0 million tranche was not funded due to CareView’s failure to achieve the related funding milestones
and there is no additional funding obligation due from the Company. Outstanding borrowings under the credit agreement bear
interest at the rate of 13.5% per annum and are payable quarterly in arrears.
As part of the original credit agreement, the Company received a warrant to purchase approximately 4.4 million shares of
common stock of CareView at an exercise price of $0.45 per share. The Company has accounted for the warrant as derivative
asset with an offsetting credit as debt discount. At each reporting period the warrant is marked to market for changes in fair value.
In connection with the October 2015 amendment of the credit agreement, the Company and CareView also agreed to amend the
warrant to purchase common stock agreement by reducing the warrant’s exercise price from $0.45 to $0.40 per share.
76
In February 2018, the Company entered into a modification agreement with CareView (the “February 2018 Modification
Agreement”) whereby the Company agreed, effective December 28, 2017, to modify the credit agreement before remedies could
otherwise have become available to the Company under the credit agreement in relation to certain obligations of CareView that
would potentially not be met, including the requirement to make principal payments. Under the February 2018 Modification
Agreement, the Company agreed that (i) a lower liquidity covenant would be applicable and (ii) principal repayment would be
delayed until December 31, 2018. In exchange for agreeing to these modifications, among other things, the exercise price of the
Company’s warrants to purchase 4.4 million shares of common stock of CareView was repriced from $0.40 to $0.03 per share
and, subject to the occurrence of certain events, CareView agreed to grant the Company additional equity interests. As a result of
the February 2018 Modification Agreement, the Company determined the loan to be impaired and it ceased to accrue interest
revenue effective October 1, 2017.
In September 2018, the Company entered into an amendment to the February 2018 Modification Agreement with CareView
whereby the Company agreed, effective as of September 28, 2018, that a lower liquidity covenant would be applicable. In
December 2018, the Company further modified the loan by agreeing that (i) a lower liquidity covenant would be applicable, (ii)
the first principal payment would be deferred until January 31, 2019, and (iii) the scheduled interest payment due December 31,
2018 would be deferred until January 31, 2019. In December 2018, and in consideration of the further modification to the credit
agreement, the Company completed an impairment analysis and determined that the note was impaired and recorded an
impairment loss of $8.2 million. The principal repayment and interest payment were subsequently deferred until May 15, 2019
under additional amendments. In May 2019, and in consideration of additional capital raised by CareView, the Company further
modified the loan by agreeing that (i) the first principal and interest payments would be deferred until September 30, 2019 (ii) the
remaining liquidity covenant would be removed, and (iii) the interest rate would be increased to 15.5%. Pursuant to further
amendments to the February 2018 Modification Agreement in September 2019 and December 2019, the Company agreed to defer
principal and interest payments until December 31, 2019.
In December 2019, and in consideration of the further modification to the credit agreement and February 2018 Modification
Agreement, the Company updated its impairment analysis and determined that an additional impairment was necessary and
recorded an impairment loss of $10.8 million. At December 31, 2019, the Company estimated the fair value of the warrant to be
less than $0.1 million. For additional information please refer to Note 7, Fair Value Measurements.
In January 2020 the Company agreed to a further amendment of the February 2018 Modification Agreement that deferred
principal repayment and interest payments until April 30, 2020, which was conditioned upon CareView raising additional
financing from third parties.
9. Leases
Lessee arrangements
The Company has operating leases for corporate offices and certain equipment. The Company’s operating leases have remaining
lease terms ranging from one to three years, some of which include options to extend the leases for up to five years.
The components of lease expense from continuing operations are as follows:
(in thousands)
Year Ended December 31,
2019
2018
Operating lease cost ..........................................................................................................................
$
760
$
Short-term lease cost .........................................................................................................................
79
Total lease cost .............................................................................................................................
$
839
$
1,019
25
1,044
77
Supplemental cash flow information related to leases for continuing operations is as follows:
(in thousands)
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases ................................................................................
Right-of-use-assets obtained in exchange for lease obligations:
Operating leases ...........................................................................................................................
Year Ended December 31,
2019
2018
$
$
762
$
1,019
2,055
N/A
_______________
N/A
Not applicable
The following table presents the lease balances relating to continuing operations within the Consolidated Balance Sheet,
weighted-average remaining lease term, and weighted-average discount rates related to the Company’s operating leases (in
thousands):
Operating Leases
Classification
December 31, 2019
Operating lease ROU assets......................... Other assets .............................................
Operating lease liabilities, current ............... Accrued liabilities ...................................
Operating lease liabilities, long-term........... Other long-term liabilities .......................
Total operating lease liabilities .................. Total operating lease liabilities................
$
$
$
1,359
760
634
1,394
Weighted-average remaining lease term ...........................................................................
Weighted-average discount rate ........................................................................................
1.9 years
6.5%
_______________
Operating leases above exclude right of use assets and liabilities of $0.3 million classified as held for sale.
Maturities of operating lease liabilities as of December 31, 2019 are as follows (in thousands):
Fiscal Year
Amount
2020 ............................................................................................................................................................
$
2021 ............................................................................................................................................................
2022 ............................................................................................................................................................
2023 ............................................................................................................................................................
2024 ............................................................................................................................................................
Thereafter....................................................................................................................................................
Total operating lease payments ................................................................................................................
Less: imputed interest .................................................................................................................................
Total operating lease liabilities.................................................................................................................
$
799
567
90
—
—
—
1,456
62
1,394
78
Future minimum operating lease payments as of December 31, 2018 were as follows (in thousands):
Fiscal Year
Amount
2019 ............................................................................................................................................................
$
2020 ............................................................................................................................................................
2021 ............................................................................................................................................................
2022 ............................................................................................................................................................
2023 ............................................................................................................................................................
Thereafter....................................................................................................................................................
1,140
1,003
559
—
—
—
Total..........................................................................................................................................................
$
2,702
As of December 31, 2019, the Company had no additional significant operating or finance leases that had not yet commenced.
Lessor arrangements
The Company has operating and sales-type leases for medical device equipment generated from its medical devices segment. The
Company’s leases have remaining lease terms of less than one year to five years, some of which include options to extend the
leases on a month-to-month basis if the customer does not notify the Company of the intention to return the equipment at the end
of the lease term. The Company typically does not offer options to terminate the leases before the end of the lease term.
The components of lease income are as follows:
(in thousands)
Classification
Year Ended December 31,
2019
2018
Sales-type lease selling price ................................................... Product revenue, net.....................
Cost of underlying asset.....................................................................................................................
Operating profit..................................................................................................................................
Interest income on the lease receivable ...................................
Interest and other income, net......
Initial direct costs incurred....................................................... Operating expense........................
Operating lease income............................................................ Product revenue, net.....................
$
$
$
$
$
542
(109)
433
53
$
$
$
746
(344)
402
51
(35) $
(41)
5,180
$
7,264
Net investment in sales-type leases are as follows:
(in thousands)
Classification
December 31, 2019 December 31, 2018
Lease payment receivable, current .................... Accounts receivable, net and
Notes receivable, current .......
Lease payment receivable, long-term................ Notes receivable, long-term
and Other assets .....................
Total lease payment receivable .........................................................................
$
$
502
$
827
1,329
$
472
753
1,225
Equipment under lease is stated at cost less accumulated depreciation and is classified as Property and equipment, net on the
Consolidated Balance Sheets. Depreciation is computed using the straight-line method over an estimated useful life of the greater
of the lease term or five years to ten years. Equipment under lease is as follows:
(in thousands)
December 31, 2019
December 31, 2018
Equipment under lease ....................................................................................
Less accumulated depreciation .......................................................................
Equipment under lease, net ........................................................................
$
$
6,652
(5,231)
1,421
$
$
6,529
(3,665)
2,864
79
Depreciation expense on equipment under lease amounted to $2.1 million, $2.7 million and $1.6 million for the years ended
December 31, 2019, 2018 and 2017, respectively.
Maturities of sales-type lease receivables as of December 31, 2019 are as follows (in thousands):
Fiscal Year
Amount
2020 ............................................................................................................................................................
$
2021 ............................................................................................................................................................
2022 ............................................................................................................................................................
2023 ............................................................................................................................................................
2024 ............................................................................................................................................................
Thereafter....................................................................................................................................................
Total undiscounted cash flows ...............................................................................................................
Present value of lease payments (recognized as lease receivables)............................................................
Difference between undiscounted and discounted cash flows....................................................................
$
Maturities of operating lease receivables as of December 31, 2019 are as follows (in thousands):
Fiscal Year
Amount
2020 ............................................................................................................................................................
$
2021 ............................................................................................................................................................
2022 ............................................................................................................................................................
2023 ............................................................................................................................................................
2024 ............................................................................................................................................................
Thereafter....................................................................................................................................................
538
396
350
126
—
—
1,410
1,329
81
2,287
1,218
426
81
—
—
Total undiscounted cash flows ...............................................................................................................
$
4,012
10. Property and Equipment
The following table provides details of the property and equipment, net:
(in thousands)
Leasehold improvements.............................................................................................................
Manufacturing equipment ...........................................................................................................
Computer and office equipment ..................................................................................................
Furniture and fixtures ..................................................................................................................
Equipment under lease ................................................................................................................
Transportation equipment............................................................................................................
Total ........................................................................................................................................
Less accumulated depreciation....................................................................................................
Construction in progress..............................................................................................................
Property and equipment, net (1) ...............................................................................................
__________________
December 31,
2019
2018
$
350
$
1,550
9,101
136
6,652
67
17,856
(16,040)
744
$
2,560
$
322
1,435
9,119
123
6,529
67
17,595
(13,952)
62
3,705
(1) The amounts above exclude $3.0 million and $3.7 million of Property and Equipment at Noden classified as held for
sale. See Note 3, Discontinued Operations Classified as Assets Held for Sale, for additional information.
80
Depreciation expense on property and equipment amounted to $2.7 million, $3.1 million and $2.1 million for the years ended
December 31, 2019, 2018 and 2017, respectively.
11. Intangible Assets
Noden
On June 8, 2018, Noden DAC entered into a Settlement Agreement (the “Settlement Agreement”) with Anchen Pharmaceuticals,
Inc. and its affiliates (“Anchen”) to resolve the patent litigation relating to infringement of U.S. Patent No. 8,617,595 (the “‘595
Patent”) based on their submission of an Abbreviated New Drug Application (“ANDA”) seeking authorization from the FDA to
market a generic version of aliskiren, the active ingredient in the Tekturna and Tekturna HCT drug. Under the Settlement
Agreement, Anchen, the sole ANDA filer of which the Company is aware, agreed to not commercialize its generic version of
aliskiren prior to March 1, 2019. Per the Settlement Agreement, Anchen may commercialize their formulation of aliskiren, but is
not permitted to commercialize a copy of Tekturna.
Accordingly, management evaluated the ongoing value of the Noden DAC asset group based upon the probability of Anchen’s
market entry of a generic version of aliskiren in the United States and the associated cash flows and conducted a test for
impairment. Due to the increased probability of a generic version of aliskiren being launched in the United States, the Company
revised its estimates of future cash flows and as a result of this analysis, determined that the sum of undiscounted cash flows was
not greater than the carrying value of the assets. Therefore, the Company performed a discounted cash flow analysis to estimate
the fair value of the asset group in accordance with ASC 360, Impairment or Disposal of Long-lived Assets. The cash flows used
in this analysis are those expected to be generated by market participants, discounted to reflect an appropriate amount of risk,
which was determined to be 21%. The Company concluded that the Noden DAC acquired product rights and customer
relationship long-lived assets, with a carrying amount of $192.5 million, were no longer recoverable and wrote them down to their
estimated fair value of $40.1 million, resulting in an impairment charge of $152.3 million in the second quarter of 2018. This
write-down is included in (Loss) income from discontinued operations before income taxes in the Consolidated Statement of
Operations and Net cash (used in) provided by operating activities - discontinued operations in the Consolidated Statement of
Cash Flows for the year ended December 31, 2018.
At December 31, 2019, due to the Company’s monetization strategy and updated forecasts for Noden, the Company revised its
estimates of future cash flows and as a result of this analysis, determined that the sum of undiscounted cash flows was not greater
than the carrying value of the assets. Therefore, the Company performed a discounted cash flow analysis to estimate the fair value
of the asset group in accordance with ASC 360. The cash flows used in this analysis are those expected to be generated by market
participants, discounted to reflect an appropriate amount of risk, which was determined to be 19%. The Company concluded that
the Noden DAC acquired product rights and customer relationship long-lived assets, with a carrying amount of $32.6 million,
were no longer recoverable and wrote them down to their estimated fair value of $10.1 million, resulting in an impairment charge
of $22.5 million in the fourth quarter of 2019. This write-down is included in (Loss) income from discontinued operations before
income taxes in the Consolidated Statement of Operations and Net cash (used in) provided by operating activities - discontinued
operations in the Consolidated Statement of Cash Flows for the year ended December 31, 2019.
During the fourth quarter of 2019, while performing its impairment analysis on its Noden intangible assets, the Company
identified an error in the 2018 impairment charge recorded on its Noden intangible assets, which resulted in a $10.5 million
overstatement of the 2018 impairment charge. As of December 31, 2018, the net carrying value of the intangible asset was
understated by $9.8 million with a corresponding overstatement of net loss for the year ended December 31, 2018. This prior year
impairment expense error was corrected as an out of period adjustment in 2019 in connection with the further impairment of the
intangible asset to $10.1 million. The Company determined that these errors were not material to its current and previously issued
financial statements.
Based on an analysis of Accounting Standards Codification (“ASC”) 250, Accounting Changes and Error Corrections (“ASC
250”), Staff Accounting Bulletin 99, Materiality (“SAB 99”) and Staff Accounting Bulletin 108, Considering the Effects of Prior
Year Misstatements when Quantifying Misstatements in Current Year Financial Statements (“SAB 108”), the Company
determined that these errors were immaterial to the previously issued annual and interim financial statements. The amount of the
intangible assets and accumulated amortization have been corrected as of December 31, 2019.
LENSAR
In April 2019, LENSAR acquired certain intellectual property from a third-party for $2.0 million in cash and obligations to pay a
$0.3 million milestone payment and royalties upon the completion of certain events, which were met prior to December 31, 2019.
81
In September 2019, LENSAR exclusively licensed certain intellectual property from a third-party for $3.5 million in cash for use
in research and development activities. The amount was immediately expensed and is included in Research and development
expense in the Consolidated Statement of Operations for the year ended December 31, 2019.
The components of intangible assets as of December 31, 2019 and 2018 were as follows:
(in thousands)
Finite-lived intangible assets:
Customer relationships 1, 2, 4.....
Acquired technology 2, 3, 5 ........
Acquired trademarks 2 .............
December 31, 2019
December 31, 2018
Gross
Carrying
Amount
Accumulated
Amortization
Net
Carrying
Amount
Gross
Carrying
Amount
Accumulated
Amortization
Net
Carrying
Amount
$
4,045
$
(884) $
3,161
$
4,045
$
11,500
570
$
16,115
$
(1,741)
(304)
(2,929) $
9,759
266
11,011
570
13,186
$
15,626
$
(533) $
(1,203)
(190)
(1,926) $
3,512
9,808
380
13,700
_______________
1 The Company acquired certain intangible assets as part of the Noden transaction. Those intangible assets are excluded
from the table above and included in “Assets held for sale.” See Note 3, Discontinued Operations Classified as Assets
Held for Sale, for additional information.
2 The Company acquired certain intangible assets as part of its acquisition of LENSAR in May 2017. They are being
amortized on a straight-line basis over a weighted-average period of 15 years. The intangible assets for customer
relationships are being amortized using a double-declining method of amortization as such method better represents
the economic benefits to be obtained. For a further discussion of the LENSAR transaction, see Note 25, Business
Combinations.
3 The Company acquired certain intangible assets as part of the foreclosure on certain of Direct Flow Medical assets. In
August 2019, the Company sold the DFM, LLC intangible assets for $5.0 million in cash and a single-digit percentage
of any net final award received as part of the acquirer’s monetization process using the intangible assets. Prior to the
sale, these intangible assets were being amortized on a straight-line basis over a weighted-average period of 10 years.
4 LENSAR acquired certain intangible assets for customer relationships from PES, which are being amortized using a
double-declining method over a period of 20 years.
5 LENSAR acquired certain intangible assets from a third-party, which are being amortized on a straight-line basis over
a period of 15 years.
Amortization expense related to our continuing operations for the years ended December 31, 2019, 2018 and 2017 was $1.3
million, $1.3 million and $0.6 million, respectively. See Note 3, Discontinued Operations Classified as Assets Held for Sale, for
information on Noden’s intangible amortization.
Based on the intangible assets recorded at December 31, 2019, and assuming no subsequent additions to or impairment of the
underlying assets, the remaining amortization expense is expected to be as follows (in thousands):
Fiscal Year
2020 ................................................................................................................................................................
2021 ................................................................................................................................................................
2022 ................................................................................................................................................................
2023 ................................................................................................................................................................
2024 ................................................................................................................................................................
Thereafter........................................................................................................................................................
$
Total remaining estimated amortization expense....................................................................................... $
Amount
1,197
1,165
1,061
997
974
7,792
13,186
82
12. Asset Acquisition
On January 8, 2018, LENSAR entered into an Asset Purchase Agreement with PES to purchase assets used in PES’ laser-assisted
cataract surgery business. The assets purchased include equipment, inventory and PES’ customer contracts. No workforce was
transferred as part of the transaction.
The Company assessed the acquisition of PES assets under ASC 805. Under ASC 805, the Company determined that the acquired
assets did not constitute a business and that the transaction would be accounted for as an asset acquisition.
The following table summarizes the fair values of the identifiable assets acquired and liabilities assumed at the acquisition date:
(in thousands)
Amount
Equipment and inventory ......................................................................................................................................
Fixed assets ...........................................................................................................................................................
Intangible assets (customer relationships) ............................................................................................................
Total identifiable assets.......................................................................................................................................
Consideration paid at closing, cash.......................................................................................................................
Conversion consideration......................................................................................................................................
Contingent consideration ......................................................................................................................................
Total fair value of consideration .........................................................................................................................
$
$
$
$
848
67
1,845
2,760
1,200
920
640
2,760
13. Accrued Liabilities
Accrued liabilities consist of the following:
(in thousands)
December 31,
2019
2018
Accrued rebates, chargebacks and other revenue reserves..........................................................
Deferred revenue .........................................................................................................................
Compensation ..............................................................................................................................
Interest .........................................................................................................................................
Legal ............................................................................................................................................
Other ............................................................................................................................................
Total (1) ....................................................................................................................................
$
5
$
959
6,823
70
921
3,145
$
11,923
$
4
1,040
3,602
344
618
3,632
9,240
________________
(1) The amounts above exclude $16.4 million and $30.1 million of accrued liabilities at Noden classified as held for sale as of
December 31, 2019 and 2018, respectively. See Note 3, Discontinued Operations Classified as Assets Held for Sale, for additional
information.
14. Convertible Senior Notes
February 2018 Notes
On February 12, 2014, the Company issued $300.0 million in aggregate principal amount, at par, of the 4.0% Convertible Senior
Notes due February 1, 2018 (the “February 2018 Notes”) Notes in an underwritten public offering, for net proceeds of $290.2
million. The February 2018 Notes were due February 1, 2018, and the Company paid interest at 4.0% on the February 2018 Notes
semiannually in arrears on February 1 and August 1 of each year, beginning August 1, 2014. A portion of the proceeds from the
February 2018 Notes, net of amounts used for purchased call option transactions and provided by the warrant transactions
described below, were used to redeem $131.7 million of the Company’s 2.975% Convertible Senior Notes due February 17, 2016.
In accordance with the accounting guidance for convertible debt instruments that may be settled in cash or other assets on
conversion, the Company was required to separately account for the liability component of the instrument in a manner that
83
reflected the market interest rate for a similar nonconvertible instrument at the date of issuance. As a result, the Company
separated the principal balance of the February 2018 Notes between the fair value of the debt component and the fair value of the
common stock conversion feature. Using an assumed borrowing rate of 7.0%, which represented the estimated market interest
rate for a similar nonconvertible instrument available to the Company on the date of issuance, the Company recorded a total debt
discount of $29.7 million, allocated $19.3 million to additional paid-in capital and allocated $10.4 million to deferred tax liability.
The discount was being amortized to interest expense over the term of the February 2018 Notes and increased interest expense
during the term of the February 2018 Notes from the 4.0% cash coupon interest rate to an effective interest rate of 6.9%.
In connection with the issuance of the February 2018 Notes, the Company entered into purchased call option transactions with
two hedge counterparties. The Company paid an aggregate amount of $31.0 million for the purchased call options with terms
substantially similar to the embedded conversion options in the February 2018 Notes. The purchased call options covered, subject
to anti-dilution and certain other customary adjustments substantially similar to those in the February 2018 Notes, approximately
13.8 million shares of the Company’s common stock. Outstanding purchased call options expired on February 1, 2018.
In addition, the Company sold to the hedge counterparties warrants exercisable, on a cashless basis, for the sale of rights to
receive shares of common stock underlying the February 2018 Notes at a strike price of $10.3610 per share, which represented a
premium of approximately 30% over the last reported sale price of the Company’s common stock of $7.97 on February 6, 2014.
The Company received an aggregate amount of $11.4 million for the sale from the two counterparties.
The purchased call options and warrants were considered indexed to the Company stock, required net-share settlement and met all
criteria for equity classification at inception and in subsequent periods. The purchased call options cost of $31.0 million, less
deferred taxes of $10.8 million, and the $11.4 million received for the warrants, were recorded as adjustments to additional paid-
in capital.
On November 20, 2015, the Company’s agent initiated the repurchase of $53.6 million in aggregate principal amount of its
February 2018 Notes for $43.7 million in cash in four open market transactions. The closing of these transactions occurred on
November 30, 2015. It was determined that the repurchase of the principal amount should be accounted for as a partial
extinguishment of the February 2018 Notes. As a result, a gain on extinguishment of $6.5 million was recorded at closing of the
transaction. The $6.5 million gain on extinguishment included the de-recognition of a proportional share of the original issuance
discount of $3.1 million, outstanding deferred issuance costs of $0.9 million and agent fees of $0.1 million. In connection with
this repurchase of the February 2018 Notes, the Company unwound a corresponding portion of the purchased call options related
to the notes. As a result of this unwinding, the Company received $0.3 million in cash. The payments received have been recorded
as an increase to additional paid-in-capital. In addition, the Company unwound a corresponding portion of the warrants issued in
connection with the notes for $0.2 million in cash, payable by the Company. The payments have been recorded as a decrease to
additional paid-in-capital.
On November 22, 2016, the Company repurchased $120.0 million in aggregate principal amount of its February 2018 Notes for
approximately $121.5 million in cash (including $1.5 million of accrued interest) in open market transactions. It was determined
that the repurchase of the principal amount be accounted for as an extinguishment. The extinguishment included the de-
recognition of a proportional share of the original issuance discount of $4.3 million and outstanding deferred issuance costs of
$1.3 million. In connection with the repurchase of the February 2018 Notes, the Company unwound a corresponding portion of
the purchased call options. The transaction did not result in any cash payments between the parties. In addition, the Company and
the counterparties agreed to unwind a corresponding portion of the warrants, which also did not result in any cash payments
between the parties.
On February 1, 2018, upon maturity of the February 2018 Notes, the Company repaid a total cash amount of $129.0 million to the
custodian, The Bank of New York Mellon Trust Company, N.A., which was comprised of $126.4 million in principal amount and
$2.6 million in accrued interest, to retire the February 2018 Notes.
84
Interest expense for the February 2018 Notes on the Company’s Consolidated Statements of Operations was as follows:
(in thousands)
Year Ended December 31,
2018
2017
2019
Contractual coupon interest............................................................................................
Amortization of debt issuance costs...............................................................................
Amortization of debt discount........................................................................................
Total ...........................................................................................................................
$
$
— $
422
$
—
—
— $
88
293
803
$
5,058
1,022
3,449
9,529
December 2021 Notes
On November 22, 2016, the Company issued $150.0 million in aggregate principal amount, at par, of 2.75% Convertible Senior
Notes due December 1, 2021 (the “December 2021 Notes”) in an underwritten public offering, for net proceeds of $145.7 million.
The December 2021 Notes are due December 1, 2021, and the Company pays interest at 2.75% on the December 2021 Notes
semiannually in arrears on June 1 and December 1 of each year, beginning June 1, 2017. A portion of the proceeds from the
December 2021 Notes, net of amounts used for the capped call transaction described below, was used to extinguish $120.0 million
of the February 2018 Notes.
In September 2019, the Company entered into privately negotiated exchange agreements with certain holders of approximately
$86.1 million aggregate principal amount of outstanding December 2021 Notes. The Company exchanged $86.1 million
aggregate principal of December 2021 Notes for an identical principal amount of 2.75% Convertible Senior Notes due December
1, 2024 (the “December 2024 Notes”), plus a cash payment of $70.00 for each $1,000 principal amount tendered (“September
Exchange Transaction”). See “December 2024 Notes” below. The terms of the remaining December 2021 Notes remained
unchanged.
The September Exchange Transaction qualified as a debt extinguishment and the Company recognized a loss on exchange of the
convertible notes of $3.9 million, which is included in Non-operating income (expense), net in the Consolidated Statement of
Operations for the year ended December 31, 2019.
Upon the occurrence of a fundamental change, as defined in the indenture entered into in connection with the December 2021
Notes (the “December 2021 Notes Indenture”), holders have the option to require the Company to repurchase their December
2021 Notes at a purchase price equal to 100% of the principal, plus accrued interest.
The December 2021 Notes are convertible under any of the following circumstances at any time prior to the close of business on
the business day immediately preceding June 1, 2021 (or at any time beginning on June 1, 2021 until the close of business on the
second scheduled trading day immediately preceding the stated maturity):
• During any fiscal quarter (and only during such fiscal quarter) commencing after the fiscal quarter ended June 30, 2017,
if the last reported sale price of Company common stock for at least 20 trading days (whether or not consecutive), in the
period of 30 consecutive trading days, ending on, and including, the last trading day of the immediately preceding fiscal
quarter, exceeds 130% of the conversion price for the notes on each applicable trading day;
• During the five business-day period immediately after any five consecutive trading-day period, which the Company
refers to as the measurement period, in which the trading price per $1,000 principal amount of notes for each trading day
of that measurement period was less than 98% of the product of the last reported sale price of Company common stock
and the conversion rate for the notes for each such trading day; or
• Upon the occurrence of specified corporate events as described in the December 2021 Notes Indenture.
The initial conversion rate for the December 2021 Notes is 262.2951 shares of the Company’s common stock per $1,000 principal
amount of December 2021 Notes, which is equivalent to an initial conversion price of approximately $3.81 per share of common
stock, subject to adjustments upon the occurrence of certain specified events as set forth in the December 2021 Notes Indenture.
In accordance with the accounting guidance for convertible debt instruments that may be settled in cash or other assets on
conversion, the Company was required to separately account for the liability component of the instrument in a manner that
reflects the market interest rate for a similar nonconvertible instrument at the date of issuance. As a result, the Company separated
the principal balance of the December 2021 Notes between the fair value of the debt component with the remainder of the
consideration being allocated to the equity component. Using an assumed borrowing rate of 9.5%, which represented the
estimated market interest rate for a similar nonconvertible instrument available to the Company on the date of issuance, the
85
Company recorded a debt discount of $4.3 million, allocated $23.8 million to Additional paid-in capital for the conversion feature
and allocated $12.8 million to deferred tax liability. The debt discount, including the conversion feature and issuance costs
allocated to debt, which remained after amortization and the effect of the September Exchange Transaction, is being amortized to
interest expense over the term of the December 2021 Notes and increases interest expense during the term of the December 2021
Notes from the 2.75% cash coupon interest rate to an effective interest rate of 9.7%. As of December 31, 2019, the remaining
discount amortization period is 1.9 years.
On December 17, 2019, the Company repurchased $44.8 million in aggregate principal amount of its December 2021 Notes for
$39.9 million in cash and 3.5 million shares of its common stock in privately negotiated transactions (the “December Exchange
Transaction”). It was determined that the repurchase of the principal amount should be accounted for as a partial extinguishment
of the December 2021 Notes. As a result, a loss on extinguishment of $2.5 million was recorded at closing of the transaction. The
loss on extinguishment included the de-recognition of a proportional share of the original issuance discount of $0.3 million and
outstanding deferred issuance costs of less than $0.1 million.
The carrying value and unamortized discount of the December 2021 Notes were as follows:
(in thousands)
December 31, 2019 December 31, 2018
Principal amount of the December 2021 Notes...........................................
Unamortized discount of liability component .............................................
Net carrying value of the December 2021 Notes....................................
$
$
19,170
(2,220)
16,950
$
$
150,000
(25,356)
124,644
Interest expense for the December 2021 Notes included in the Company’s Consolidated Statements of Operations was as follows:
(in thousands)
Year Ended December 31,
2019
2018
Contractual coupon interest.................................................................................................................
Amortization of debt issuance costs ....................................................................................................
Amortization of debt discount .............................................................................................................
Amortization of conversion feature.....................................................................................................
Total ................................................................................................................................................
$
$
3,390
$
4,125
64
459
5,973
76
542
6,611
9,886
$
11,354
As of December 31, 2019 and 2018, the December 2021 Notes are not convertible.
Capped Call Transaction
In connection with the offering of the December 2021 Notes, the Company entered into a privately-negotiated capped call
transaction with an affiliate of the underwriter of such issuance. The aggregate cost of the capped call transaction was $14.4
million. The capped call transaction is generally expected to reduce the potential dilution upon conversion of the December 2021
Notes and/or partially offset any cash payments the Company is required to make in excess of the principal amount of converted
December 2021 Notes in the event that the market price per share of the Company’s common stock, as measured under the terms
of the capped call transaction, is greater than the strike price of the capped call transaction. This initially corresponds to the
approximate $3.81 per share conversion price of the December 2021 Notes and is subject to anti-dilution adjustments
substantially similar to those applicable to the conversion rate of the December 2021 Notes. The cap price of the capped
call transaction was initially $4.88 per share and is subject to certain adjustments under the terms of the capped call transaction.
The Company will not be required to make any cash payments to the option counterparty upon the exercise of the options that are
a part of the capped call transaction, but the Company will be entitled to receive from it an aggregate amount of cash and/or
number of shares of the Company’s common stock, based on the settlement method election chosen for the related convertible
senior notes, with a value equal to the amount by which the market price per share of the Company’s common stock, as measured
under the terms of the capped call transaction, is greater than the strike price of the capped call transaction during the relevant
valuation period under the capped call transaction, with such number of shares of the Company’s common stock and/or amount of
cash subject to the cap price.
The Company evaluated the capped call transaction under authoritative accounting guidance and determined that it should be
accounted for as a separate transaction and classified as a net reduction to additional paid-in capital within stockholders’ equity
with no recurring fair value measurement recorded.
86
In connection with the September Exchange Transaction, the Company unwound a portion of the capped call entered into when
the December 2021 Notes were issued, as they were no longer scheduled to mature in 2021. This generated proceeds, of which
$0.9 million, was paid to the Company. The $0.9 million proceeds from the unwind of the capped call, which reflected the value
of the options outstanding at the time of the September Exchange Transaction and the average share price of the Company’s
common stock were included as an increase to Additional paid-in capital within stockholders’ equity.
In connection with the December Exchange Transaction, the Company unwound a corresponding portion of the capped call
related to the notes and repurchased 1.6 million shares of its common stock from the counterparty. The Company paid the capped
call counterparty $3.1 million, representing $5.6 million for the common stock repurchased from the counterparty, net of $2.5
million owed from the counterparty to the Company for unwinding the capped call. The common stock repurchased was reflected
as a decrease to Retained earnings within stockholders’ equity. The proceeds from the capped call were included as an increase to
Additional paid-in capital within stockholders’ equity.
December 2024 Notes
On September 17, 2019, in connection with the September Exchange Transaction, the Company exchanged $86.1 million
aggregate principal of December 2021 Notes for an identical aggregate original principal amount of December 2024 Notes, plus a
cash payment of $70.00 for each $1,000 principal amount exchanged, totaling approximately $6.0 million. The December 2024
Notes are due December 1, 2024, and the Company pays interest at 2.75% on the December 2024 Notes semiannually in arrears
on June 1 and December 1 of each year, beginning December 1, 2019. The original principal of the December 2024 Notes will
accrete at a rate of 2.375% per year (“Accretion Interest”) commencing September 17, 2019 through the maturity of the
December 2024 Notes. The accreted principal amount of the December 2024 Notes is payable in cash upon maturity and is
included in Other long-term liabilities.
Upon the occurrence of a fundamental change, as defined in the indenture entered into in connection with the December 2024
Notes (the “December 2024 Notes Indenture”), holders have the option to require the Company to repurchase their December
2024 Notes at a purchase price equal to 100% of the accreted principal amount of such December 2024 Notes, plus accrued
interest on the original principal amount thereon.
The December 2024 Notes are convertible under any of the following circumstances at any time prior to the close of business on
the business day immediately preceding June 1, 2024 (or at any time beginning on June 1, 2024 until the close of business on the
second scheduled trading day immediately preceding the stated maturity):
• During any fiscal quarter (and only during such fiscal quarter) commencing after the fiscal quarter ended December 31,
2019, if the last reported sale price of Company common stock for at least 20 trading days (whether or not consecutive),
in the period of 30 consecutive trading days, ending on, and including, the last trading day of the immediately preceding
fiscal quarter, exceeds 130% of the conversion price for the notes on each applicable trading day;
• During the five business-day period immediately after any five consecutive trading-day period, which the Company
refers to as the measurement period, in which the trading price per $1,000 original principal amount of notes for each
trading day of that measurement period was less than 98% of the product of the last reported sale price of Company
common stock and the conversion rate for the notes for each such trading day;
• Upon the occurrence of specified corporate events or upon a redemption of the notes, in each case as described in the
December 2024 Notes Indenture; or
• On or after June 1, 2024, at the option of the holder prior to the second scheduled trading day preceding December 1,
2024.
In accordance with the terms of the December 2024 Notes Indenture, the Company has the right, but not the obligation, to redeem
all or any portion of the December 2024 Notes that is equal to $1,000 original principal amount or an integral multiple of $1,000
prior to their scheduled maturity on a redemption date beginning on or after December 1, 2021 and on or before the 60th
scheduled trading day before December 1, 2024, for a cash purchase price equal to the redemption price, but only if the last
reported sale price of Company common stock exceeds 128% of the conversion price for the December 2024 Notes on (i) each of
at least 20 trading Days (whether or not consecutive) during the 30 consecutive trading days ending on, and including, the trading
day immediately before the redemption notice date for such redemption; and (ii) the trading day immediately before such
redemption notice date. The redemption price for the December 2024 Notes called for redemption is equal to the then accreted
principal amount of such December 2024 Notes plus accrued but unpaid interest on the original principal amount thereon. The
calling of any December 2024 Notes for redemption will constitute a make-whole fundamental change with respect to such notes,
87
entitling the holders who convert such December 2024 Notes called for redemption prior to the applicable redemption date to
receive an increase in the applicable conversion rate, as described in the December 2024 Notes Indenture.
The initial conversion rate for the December 2024 Notes is 262.2951 shares of the Company’s common stock per $1,000 original
principal amount of December 2024 Notes, which is equivalent to an initial conversion price of approximately $3.81 per share of
common stock, subject to adjustments upon the occurrence of certain specified events as set forth in the December 2024 Notes
Indenture.
In accordance with the accounting guidance for an extinguishment of convertible debt instruments with a cash conversion feature,
the Company was required to allocate the fair value of the consideration transferred between the liability component and the
equity component. To calculate the fair value of the debt immediately prior to derecognition, the carrying value was recalculated
in a manner that reflected the estimated market interest rate for a similar nonconvertible instrument at the date of issuance. Using
an assumed borrowing rate of 7.05% the Company calculated the fair value of the debt representing the amount allocated to the
liability component of the December 2024 Notes with the remainder of the consideration allocated to the equity conversion
feature, to reflect the reacquisition of the embedded conversion option. The conversion feature together with the fees allocated to
the debt are accounted for as a debt discount. As a result of the September Exchange Transaction, the Company recorded a total
debt discount of $9.4 million, which included the cash conversion feature of $8.1 million and the debt issuance fees of $1.3
million, charged $5.5 million to Additional paid-in capital ($13.5 million charge to Additional paid-in capital representing the
reduction to the 2021 equity component, partially offset by the $8.1 million allocated to equity for the 2024 notes) and recorded
$1.2 million to deferred tax liability. The net amount charged to Additional paid-in capital represents the difference between the
consideration paid for the September Exchange Transaction and the fair value of the convertible debt prior to the extinguishment.
The Accretion Interest and debt discount, including the conversion feature and issuance costs allocated to debt, are being
amortized to interest expense over the term of the December 2024 Notes which increases interest expense during the term of the
December 2024 Notes from the 2.75% cash coupon interest rate to an effective interest rate of 7.5%. As of December 31, 2019,
the remaining discount amortization period is 4.9 years.
On December 17, 2019, in connection with the December Exchange Transaction, the Company repurchased $74.6 million in
aggregate principal amount of its December 2024 Notes for $58.0 million in cash and 9.9 million shares of its common stock in
privately negotiated transactions. It was determined that the repurchase of the principal amount should be accounted for as a
partial extinguishment of the December 2024 Notes. As a result, a loss on extinguishment of $2.1 million was recorded at closing
of the transaction. The loss on extinguishment included the de-recognition of a proportional share of the deferred issuance costs of
$1.1 million.
The carrying value, accretion and unamortized discount of the December 2024 Notes were as follows:
(in thousands)
December 31, 2019
Principal amount of the December 2024 Notes.............................................................................................. $
Unamortized discount of liability component ................................................................................................
Net carrying value of the December 2024 Notes....................................................................................... $
11,500
(1,200)
10,300
Interest expense for the December 2024 Notes included in the Company’s Consolidated Statement of Operations was as follows:
(in thousands)
Year Ended
December 31, 2019
Contractual coupon interest ............................................................................................................................ $
Accretion Interest on outstanding principal....................................................................................................
Amortization of debt issuance costs ...............................................................................................................
Amortization of conversion feature ................................................................................................................
Total ........................................................................................................................................................... $
598
517
53
350
1,518
Capped Call Transaction
In connection with the issuance of the December 2024 Notes in the September Exchange Transaction, the Company entered into a
privately-negotiated capped call transaction with an affiliate of the underwriter of such issuance. The aggregate cost of the capped
88
call transaction was $4.5 million. The capped call transaction is generally expected to reduce the potential dilution upon
conversion of the December 2024 Notes and/or partially offset any cash payments the Company is required to make in excess of
the principal amount of converted December 2024 Notes in the event that the market price per share of the Company’s common
stock, as measured under the terms of the capped call transaction, is greater than the strike price of the capped call transaction.
This initially corresponds to the approximate $3.81 per share conversion price of the December 2024 Notes and is subject to anti-
dilution adjustments substantially similar to those applicable to the conversion rate of the December 2024 Notes. The cap price of
the capped call transaction was initially $4.88 per share and is subject to certain adjustments under the terms of the capped
call transaction. The Company will not be required to make any cash payments to the option counterparty upon the exercise of the
options that are a part of the capped call transaction, but the Company will be entitled to receive from it an aggregate amount of
cash and/or number of shares of the Company’s common stock, based on the settlement method election chosen for the related
convertible senior notes, with a value equal to the amount by which the market price per share of the Company’s common stock,
as measured under the terms of the capped call transaction, is greater than the strike price of the capped call transaction during the
relevant valuation period under the capped call transaction, with such number of shares of the Company’s common stock and/or
amount of cash subject to the cap price.
The Company evaluated the capped call transaction under authoritative accounting guidance and determined that it should be
accounted for as a separate transaction and classified as a net reduction to additional paid-in capital within stockholders’ equity
with no recurring fair value measurement recorded.
In connection with the December Exchange Transaction, the Company unwound a corresponding portion of the capped call
related to the notes and repurchased 1.6 million shares of its common stock from the counterparty. The Company paid the capped
call counterparty $1.2 million, representing $5.4 million for the common stock repurchased from the counterparty, net of $4.2
million owed from the counterparty to the Company for unwinding the capped call. The common stock repurchased was reflected
as a decrease to Retained earnings within stockholders’ equity. The proceeds from the capped call were included as an increase to
Additional paid-in capital within stockholders’ equity.
The Company evaluated the capped call transaction under authoritative accounting guidance and determined that it should be
accounted for as separate transaction from the debt as it was entered into with a separate counterparty and does not relate to the
same risk. The $4.5 million premium for the capped call was classified as a reduction to Additional paid-in capital within
stockholders’ equity and will not be subject to recurring fair value measurement.
As of December 31, 2019, the future minimum principal payments under the December 2021 and December 2024 Notes were:
(in thousands)
December 2021
Notes
December 2024
Notes
Total
2020 ...................................................................................................................
2021 ...................................................................................................................
2022 ...................................................................................................................
2023 ...................................................................................................................
2024 ...................................................................................................................
Thereafter ..........................................................................................................
Total ..............................................................................................................
$
— $
— $
19,170
—
—
—
—
—
—
—
11,500
—
—
19,170
—
—
11,500
—
$
19,170
$
11,500
$
30,670
89
15. Other Long-Term Liabilities
Other long-term liabilities consist of the following:
(in thousands)
December 31,
2019
2018
Uncertain tax positions ................................................................................................................
Deferred tax liability....................................................................................................................
Accrued lease liability .................................................................................................................
Long-term incentive ....................................................................................................................
Other ............................................................................................................................................
Total 1......................................................................................................................................
$
37,574
$
1,571
10,700
—
1,020
31,706
15,620
10,700
125
465
$
50,865
$
58,616
________________
1 The amounts above exclude $0.1 million and zero of Other long-term liabilities at Noden classified as held for sale as of
December 31, 2019 and 2018, respectively. See Note 3, Discontinued Operations Classified as Assets Held for Sale, for additional
information.
16. Commitments and Contingencies
Lease Guarantee
In connection with the spin-off by the Company of Facet Biotech Corporation (“Facet”), the Company entered into amendments
to the leases for the Company’s former facilities in Redwood City, California, under which Facet was added as a co-tenant, and a
Co-Tenancy Agreement, under which Facet agreed to indemnify the Company for all matters related to the leases attributable to
the period after the spin-off date. In April 2010, Abbott Laboratories acquired Facet and later renamed the entity AbbVie
Biotherapeutics, Inc. (“AbbVie”). If AbbVie were to default under its lease obligations, the Company could be held liable by the
landlord as a co-tenant and, thus, the Company has in substance guaranteed the payments under the lease agreements for the
Redwood City facilities. As of December 31, 2019, the total lease payments for the duration of the guarantee, which runs through
December 2021, are approximately $22.6 million.
The Company prepared a discounted, probability weighted cash flow analysis to calculate the estimated fair value of the lease
guarantee as of the spin-off. The Company was required to make assumptions regarding the probability of Facet’s default on the
lease payment, the likelihood of a sublease being executed and the times at which these events could occur. These assumptions are
based on information that the Company received from real estate brokers and the then-current economic conditions, as well as
expectations of future economic conditions. The fair value of this lease guarantee was charged to Additional paid-in capital upon
the spin-off and any future adjustments to the carrying value of the obligation will also be recorded in Additional paid-in capital.
The Company has recorded a liability of $10.7 million on its Consolidated Balance Sheets as of December 31, 2019 and 2018,
related to this guarantee. In future periods, the Company may adjust this liability for any changes in the ultimate outcome of this
matter that are both probable and estimable.
Irrevocable Letters of Credit
On June 30, 2016, the Company purchased a $75.0 million certificate of deposit, which is designated as cash collateral for the
$75.0 million letter of credit issued on July 1, 2016 with respect to the first anniversary payment under the Noden Purchase
Agreement. In addition, the Company provided an irrevocable and unconditional guarantee to Novartis, to pay up to $14.0 million
of the remaining amount of the first anniversary payment not covered by the letter of credit. The Company concluded that both
guarantees were contingent obligations and should be accounted for in accordance with ASC 450, Contingencies. Further, it was
concluded that both guarantees did not meet the conditions to be accrued at June 30, 2016 and December 31, 2016. On July 3,
2017, the first anniversary payment of $89.0 million was paid pursuant to the Noden Purchase Agreement and the $14.0 million
guarantee expired. On July 31, 2017, the $75.0 million certificate of deposit matured, and on August 1, 2017, the letter of credit
terminated.
90
Purchase Obligations
Noden DAC and Novartis entered into a supply agreement pursuant to which Novartis will manufacture and supply to Noden
DAC a bulk tableted form of the Noden Products and active pharmaceutical ingredient (“API”). In May 2019, Noden DAC and
Novartis entered into an amended supply agreement pursuant to which Novartis will supply to Noden DAC a bulk tableted form
of the Noden Products through 2020 and API through June 2021. The supply agreement may be terminated by either party for
material breach that remains uncured for a specified time period. Under the terms of the amended supply agreement, Noden DAC
is committed to purchase certain quantities of bulk product and API that would amount to approximately $61.7 million through
June 2021, of which $39.8 million is committed over the next twelve months, which are guaranteed by the Company. While the
supply agreement provides that the parties will agree to reasonable accommodations with respect to changes in firm orders, the
Company expects that Noden DAC will meet the requirements of the supply agreement, unless otherwise negotiated.
LENSAR entered into various supply agreements for the manufacture and supply of certain components. The supply agreements
commit LENSAR to a minimum purchase obligation of approximately $10.4 million over the next twenty-four months of which
$9.6 million is due in the next 12 months, a portion of which are guaranteed by the Company. LENSAR expects to meet these
requirements.
Escrow Receivable
On April 1, 2014, the Company entered into a note purchase agreement with Accel 300, a wholly-owned subsidiary of kaléo, Inc.
(“kaléo”), pursuant to which the Company acquired $150.0 million of secured notes due 2029 (the “kaléo Note”). The kaléo Note
was issued pursuant to an indenture between Accel 300 and U.S. Bank, National Association, as trustee, and was secured by 20%
of net sales of its first approved product, Auvi-Q® (epinephrine auto-injection, USP) (known as Allerject® in Canada) and 10% of
net sales of kaléo’s second proprietary auto-injector based product, EVZIO (naloxone hydrochloride injection) (the “kaléo
Revenue Interests”), and a pledge of kaléo’s equity ownership in Accel 300.
On September 21, 2017, the Company entered into an agreement (the “kaléo Note Sale Agreement”) with MAMKangaroo
Lender, LLC, a Delaware limited liability company (the kaléo Purchaser”), pursuant to which the Company sold its entire interest
in the kaléo Note for an aggregate cash purchase price of $141.7 million.
Pursuant to the terms of the kaléo Note Sale Agreement, $1.4 million of the aggregate purchase price was deposited into an
escrow account as a potential payment against certain contingencies. The escrow period ended on March 20, 2019 and the escrow
agent released the entire $1.4 million to the Company.
17. Stockholders’ Equity
Stock Repurchase Program
On March 1, 2017, the Company announced that its board of directors authorized the repurchase through March 2018 of issued
and outstanding shares of the Company’s common stock having an aggregate value of up to $30.0 million pursuant to a share
repurchase program. The repurchases under the share repurchase program were made from time to time in the open market or in
privately negotiated transactions and were funded from the Company’s working capital. All shares of common stock repurchased
under the Company’s share repurchase program were retired and restored to authorized but unissued shares of common stock at
June 30, 2017. The Company repurchased 13.3 million shares of its common stock under the share repurchase program during the
fiscal year ended December 31, 2017 for an aggregate purchase price of $30.0 million, or an average cost of $2.25 per share,
including trading commissions.
On September 25, 2017, the Company announced that its board of directors authorized the repurchase of issued and outstanding
shares of the Company’s common stock having an aggregate value of up to $25.0 million pursuant to a share repurchase program.
The repurchases under the share repurchase program were made from time to time in the open market or in privately negotiated
transactions and were funded from the Company’s working capital. All shares of common stock repurchased under this share
repurchase program were retired and restored to authorized but unissued shares of common stock. The Company repurchased 8.7
million shares of its common stock under the share repurchase program during the fiscal year ended December 31, 2018, for an
aggregate purchase price of $25.0 million, or an average cost of $2.86 per share, including trading commissions.
On September 24, 2018, the Company announced that its board of directors authorized the repurchase of issued and outstanding
shares of the Company’s common stock having an aggregate value of up to $100.0 million pursuant to a share repurchase
program. Repurchases under this share repurchase program were made from time to time in the open market or in privately
negotiated transactions and funded from the Company’s working capital. All shares of common stock repurchased under this
91
repurchase program were retired and restored to authorized but unissued shares of common stock at July 31, 2019. The Company
repurchased 31.0 million shares of its common stock under this share repurchase program for an aggregate purchase price of
$100.0 million, or an average cost of $3.22 per share, including trading commissions.
On December 9, 2019, the Company announced that its board of directors authorized the repurchase of issued and outstanding
shares of the Company's common stock and convertible notes up to an aggregate value of $200 million. On December 16, 2019,
the Company announced that its board of directors approved a $75 million increase to the aforementioned $200 million
repurchase program to acquire outstanding PDL common stock and convertible notes. Repurchases under the new repurchase
program will be made from time to time in the open market or in privately negotiated transactions and funded from the
Company’s working capital. The amount and timing of such repurchases will depend upon the price and availability of shares or
convertible notes, general market conditions and the availability of cash. Repurchases may also be made under a trading plan
under Rule 10b5-1, which would permit shares or convertible notes to be repurchased when the Company might otherwise be
precluded from doing so because of self-imposed trading blackout periods or other regulatory restrictions. All shares of common
stock repurchased under the Company’s new share repurchase program are expected to be retired and restored to authorized but
unissued shares of common stock. All convertible notes repurchased under the program will be retired. As of December 31, 2019,
the Company had repurchased $44.8 million in aggregate principal amount of 2021 Convertible Notes and $74.6 million in
aggregate principal amount of 2024 Convertible Notes for consideration consisting of a cash payment of $97.9 million and the
issuance of 13.4 million shares of the Company’s common stock. As of December 31, 2019, the Company had not repurchased
any shares of common stock under this program. This repurchase program may be suspended at any time without notice.
18. Accumulated Other Comprehensive Income
Comprehensive income is comprised of net (loss) income and other comprehensive (loss) income. The Company includes
unrealized net gains (losses) on investments held in its available-for-sale securities and unrealized gains (losses) on its cash flow
hedges in other comprehensive (loss) income, and presents the amounts net of tax. The Company’s other comprehensive (loss)
income is included in the Company’s Consolidated Statements of Comprehensive (Loss) Income.
The balance of “accumulated other comprehensive (loss) income,” net of tax, was as follows:
(in thousands)
Unrealized
gains
(losses) on
available-for-
sale securities
Total
Accumulated
Other
Comprehensive
Income
Balance at December 31, 2016.................................................................................................
$
— $
Activity for the year ended December 31, 2017 ......................................................................
Ending Balance at December 31, 2017 ....................................................................................
Activity for the year ended December 31, 2018 ......................................................................
Ending Balance at December 31, 2018 ....................................................................................
1,181
1,181
(1,181)
—
Activity for the year ended December 31, 2019 ......................................................................
Ending Balance at December 31, 2019 ....................................................................................
$
—
— $
—
1,181
1,181
(1,181)
—
—
—
19. Stock-Based Compensation
The Company grants restricted stock awards and stock options pursuant to a stockholder approved stock-based incentive plan.
The following table summarizes the Company’s stock option and restricted stock award compensation expense during the years
ended December 31, 2019, 2018 and 2017:
92
Stock-based Compensation
(in thousands)
Year Ended December 31,
2019
2018
2017
Employees and directors............................................................................................................
$
6,834
$
4,337
$
2,957
The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. Expected
volatility is based on the historical volatility of our common stock over the estimated expected life of the options. The expected
term represents the period of time the options are expected to be outstanding. The expected term is based on the “simplified
method” as defined by the SEC Staff Accounting Bulletin No. 110 (Topic 14.D.2). The Company uses the “simplified method”
due to the lack of sufficient historical exercise data to provide a reasonable basis upon which to otherwise estimate the expected
life of the options. The risk-free rate is based on yields on U.S. Treasury securities with a maturity similar to the estimated
expected term of the options. The fair value of restricted stock awards is based on the closing price of the Company’s common
stock on the grant date.
The fair value of our stock options was estimated assuming no expected dividends and the following weighted-average
assumptions:
Range of expected term (in years)...................................................
Range of risk-free interest rate ........................................................
Expected volatility...........................................................................
3.5
-
6.1
3.5
-
6.0
1.5% -
3.0%
2.7% -
3.0%
40%
40%
Year Ended December 31,
2019
2018
2017
3.7
2.0%
44%
Stock-Based Incentive Plans
2005 Equity Incentive Plan
The Company currently has one active stock-based incentive plan under which it may grant stock-based awards to the Company’s
employees, directors and non-employees.
Under the Company’s Amended and Restated 2005 Equity Incentive Plan effective June 8, 2018 (the “2005 Equity Incentive
Plan”), the Company is authorized to issue a variety of incentive awards, including stock options, stock appreciation rights,
restricted stock awards, restricted stock unit awards, performance share and performance unit awards, deferred compensation
awards and other stock-based or cash-based awards. As of December 31, 2019, awards granted under the 2005 Equity Incentive
Plan consisted of stock options and restricted stock awards. There were no other grants of any other award types under the 2005
Equity Incentive Plan.
In June 2018, the Company’s stockholders approved an amendment and restatement of the 2005 Equity Incentive Plan that
increased the number of shares available for grant by 15,000,000 to 26,200,000. The number of shares of common stock
authorized for issuance, shares of common stock issued upon exercise of options or grant of restricted stock awards, shares of
common stock subject to outstanding awards and shares available for grant under this plan as of December 31, 2019, are as
follows:
Title of Plan
Total Shares of
Common Stock
Authorized
Total Shares of
Common Stock
Issued
Total Shares of
Common Stock
Available for
Grant
2005 Equity Incentive Plan ...............................................................................
26,200,000
15,889,993
10,310,007
93
Stock Options
The following table summarizes the option activity under the 2005 Equity Incentive Plan for the year ended December 31, 2019:
Options
(in thousands)
Weighted-
Average
Exercise
Price
Weighted-Average
Remaining
Contractual Term
(Years)
Aggregate
Intrinsic
Value
(in thousands)
Outstanding at beginning of year .................................
Granted .........................................................................
Forfeited .......................................................................
Outstanding at end of year ...........................................
6,908
$
$
5,796
(1,052) $
$
11,652
Exercisable at end of year ............................................
3,154
$
2.76
3.58
3.27
3.12
2.77
9.1
8.5
8.1
$
$
$
1,099
3,473
1,526
Options to purchase common stock generally vest over a 3 or 4-year period and are generally granted for a term of 10 years.
The weighted-average grant-date fair value of options granted during the year ended December 31, 2019 was $1.49. The total fair
value of options vested during the year ended December 31, 2019 was approximately $5.6 million. Total unrecognized
compensation expense of $7.8 million related to options will be recognized over a weighted-average period of 1.6 years.
Restricted Stock Awards
Restricted stock has the same rights as other issued and outstanding shares of the Company’s common stock, including, in some
cases, the right to accrue dividends, which are held in escrow until the award vests. The compensation expense related to these
awards is determined using the fair market value of the Company’s common stock on the date of the grant, and the compensation
expense is recognized ratably over the vesting period. Under the Company’s restricted stock plans, restricted stock awards
typically vest over one to five years and compensation expense associated with these awards is recognized on a straight-line basis
over the vesting period. In addition to service requirements, vesting of restricted stock awards may be subject to the achievement
of specified performance goals set by the Compensation Committee. If the performance goals are not met, no compensation
expense is recognized and any previously recognized compensation expense is reversed.
The following table summarizes the restricted stock award activity under the 2005 Equity Incentive Plan for the year ended
December 31, 2019:
Unvested at beginning of year ....................................................................................................
Awards granted ......................................................................................................................
Awards vested ........................................................................................................................
Withheld related to net settlement .........................................................................................
Forfeited.................................................................................................................................
Unvested at end of year ..............................................................................................................
2019
Weighted-
average grant-
date fair value
per share
Number of
shares
(in thousands)
723
$
917
$
(519) $
(64) $
(124) $
$
933
2.79
3.62
2.79
2.78
3.18
3.56
The total fair value of restricted stock awards vested during the years ended December 31, 2019, 2018 and 2017 was
approximately $1.4 million, $2.1 million and $2.8 million, respectively.
The weighted-average grant date fair value for restricted stock awards granted under the 2005 Equity Incentive Plan for the years
end December 31, 2019, 2018 and 2017 was $3.62, $2.61 and $2.15, respectively.
94
At December 31, 2019, there was approximately $1.6 million of total unrecognized compensation expense related to restricted
stock awards granted under the 2005 Equity Incentive Plan, which is expected to be recognized over a weighted-average period of
1.2 years.
Inducement Award Agreements
On September 12, 2017, the Company granted 961,000 shares of common stock in the form of a non-statutory inducement stock
option grant pursuant to a non-statutory inducement stock option agreement and granted 240,200 shares of our common stock in
the form of an inducement restricted stock grant pursuant to an inducement restricted stock agreement. These inducement awards
were not granted under the 2005 Equity Incentive Plan.
Inducement Stock Option Activity
As of December 31, 2019, all stock option awarded under the non-statutory inducement stock option agreement were outstanding
and 373,719 shares were exercisable. The total fair value of options vested during the year ended December 31, 2019 was
approximately $0.5 million. Total unrecognized compensation expense of $0.2 million related to these options will be recognized
over a weighted-average period of 1.8 years.
Inducement Restricted Stock
As of December 31, 2019, 80,067 shares of restricted stock awarded under the non-statutory inducement restricted stock
agreement were outstanding and unvested. The total fair value of the restricted stock awards vested during the year ended
December 31, 2019 was approximately $0.3 million.
Compensation expense associated with unvested restricted stock awards is recognized on a straight-line basis over the vesting
period. At December 31, 2019, there was approximately $0.1 million of total unrecognized compensation expense related to
restricted stock awards granted under the non-statutory inducement restricted stock agreement, which is expected to be recognized
over a weighted-average period of 1.0 year.
20. Revenue from Contracts with Customers
Disaggregation of Revenue
The Company disaggregates its revenue from contracts with customers by segment and geographic location as the Company
believes it best depicts how the nature, amount, timing and uncertainty of its revenue and cash flows are affected by economic
factors. In the following table, revenue is disaggregated by segment and primary geographical market for the years ended
December 31, 2019 and 2018:
(in thousands)
Primary geographical markets:
Year Ended December 31, 2019
Medical
Devices
Pharmaceutical (1)
Year Ended December 31, 2018
Medical
Devices
Pharmaceutical (1)
North America........................................................ $
Europe ....................................................................
Asia ........................................................................
Other ......................................................................
Total revenue from contracts with customers (2) $
10,155
$
26,034
$
7,425
$
3,438
11,536
433
25,562
$
22,816
6,243
—
55,093
$
2,451
7,136
377
17,389
$
41,900
25,259
13,637
—
80,796
_______________
(1) The revenue from the Company’s Pharmaceutical segment for the years ended December 31, 2019 and 2018 is
included in (Loss) income from discontinued operations. For additional information, see Note 3, Discontinued
Operations Classified as Assets held for sale.
(2) The table above does not include lease revenue from the Company’s Medical Devices segment of $5.2 million and
$7.3 million for the years ended December 31, 2019 and 2018, respectively. For additional information, see Note 9,
Leases.
95
Contract Balances
The following table provides information about receivables, contract assets and contract liabilities from contracts with customers:
(in thousands)
December 31, 2019 December 31, 2018
Receivables, current and non-current, net ................................................................
Contract assets..........................................................................................................
Contract liabilities ....................................................................................................
$
$
$
10,377
3,512
4,024
$
$
$
20,655
2,595
8,938
Receivables, Net—Receivables, net, include amounts billed and due from customers. The amounts due are stated at their net
estimated realizable value and are classified as current or noncurrent based on the timing of when the Company expects to receive
payment. The Company maintains an allowance for doubtful accounts to provide for the estimated amount of receivables that will
not be collected. The allowance is based upon an assessment of customer creditworthiness, historical payment experience, the age
of outstanding receivables and collateral to the extent applicable. Receivables, net for our Pharmaceutical segment are classified
as a current asset and included in Assets held for sale. See Note 3, Discontinued Operations Classified as Assets Held for Sale, for
additional information.
Contract Assets—The Company’s contract assets represent revenue recognized for performance obligations completed before an
unconditional right to payment exists, and therefore invoicing or associated reporting from the customer regarding the
computation of the net product sales has not yet occurred. The Company’s contract assets are only attributable to the
Pharmaceutical segment, and as such classifies contract assets in Assets held for sale in the Company’s Consolidated Balance
Sheets.
(in thousands)
Medical Devices
Pharmaceutical
Total
Contract assets at December 31, 2018.............................................
Contract assets recognized..........................................................
Payments received ......................................................................
Contract assets at December 31, 2019.............................................
$
$
— $
—
—
— $
2,595
$
12,259
(11,342)
3,512
$
2,595
12,259
(11,342)
3,512
Contract Liabilities—The Company’s contract liabilities consist of deferred revenue for products sold to customers for which
the performance obligation has not been completed by the Company. The Company classifies deferred revenue as current or
noncurrent based on the timing of when it expects to recognize revenue. The noncurrent portion of deferred revenue is included in
Other long-term liabilities in the Company’s Consolidated Balance Sheets. The Pharmaceutical deferred revenue is classified as a
current liability and included in Liabilities held for sale.
(in thousands)
Medical Devices
Pharmaceutical
Total
Contract liabilities at December 31, 2018 .......................................
Additions.....................................................................................
Amounts recognized in revenue .................................................
Contract liabilities at December 31, 2019 .......................................
$
$
1,167
$
916
(1,008)
1,075
$
7,771
$
2,123
(6,945)
2,949
$
8,938
3,039
(7,953)
4,024
Transaction Price Allocated to Future Performance Obligations
The following table includes estimated revenue expected to be recognized in the future related to performance obligations that are
unsatisfied (or partially unsatisfied) at the end of the reporting period.
(in thousands)
Twelve months ended
December 31, 2020
Thereafter
Total
Pharmaceutical product sales...................................................................
Medical device sales ................................................................................
$
$
2,326
5,473
$
$
— $
6,280
$
2,326
11,753
96
The Company does not disclose the value of unsatisfied performance obligations for (i) contracts with original expected lengths
of one year or less or (ii) contracts for which the Company recognizes revenue at the amount to which it has the right to invoice
for the products delivered or services performed.
21. Segment Information
In connection with its investment in Evofem in the second quarter of 2019, the Company added a fourth reportable segment,
“Strategic Positions.” This had no impact on the Company’s prior segment reporting structure.
Information regarding the Company’s segments for the year ended December 31, 2019 and 2018 is as follows:
Revenues by segment
(in thousands)
Year Ended December 31,
2019
2018
Medical Devices............................................................................................................................
Strategic Positions.........................................................................................................................
Pharmaceutical ..............................................................................................................................
Income Generating Assets.............................................................................................................
Total revenues...........................................................................................................................
$
$
30,742
$
24,652
—
—
(36)
30,706
$
—
—
7,376
32,028
________________
The table above excludes revenues related to discontinued operations. See Note 3, Discontinued Operations Classified as
Assets Held for Sale, for additional information.
(Loss) income by segment
(in thousands)
Year Ended December 31,
2019
2018
Medical Devices ............................................................................................................................
Strategic Positions .........................................................................................................................
Pharmaceutical (1)...........................................................................................................................
Income Generating Assets (1) .........................................................................................................
Total net (loss) income..............................................................................................................
$
$
(5,230) $
28,758
(19,048)
(74,891)
(70,411) $
(5,086)
—
(98,368)
34,595
(68,859)
________________
(1) The (Loss) income by segment presented above includes amounts related to both continuing and discontinued operations.
See Note 3, Discontinued Operations Classified as Assets Held for Sale, for additional information.
Long-lived assets by segment
(in thousands)
Year Ended December 31,
2019
2018
Medical Devices.............................................................................................................................
Strategic Positions..........................................................................................................................
Pharmaceutical (1)...........................................................................................................................
Income Generating Assets..............................................................................................................
Total long-lived assets...............................................................................................................
$
$
2,435
$
—
2,960
125
5,520
$
3,545
—
3,682
160
7,387
________________
(1) The amounts above include Property and Equipment in the Pharmaceutical segment classified as Assets held for sale. See
Note 3, Discontinued Operations Classified as Assets Held for Sale, for additional information.
The operations for the Medical Devices segment are primarily located in the United States and the operations for the
Pharmaceutical segment are primarily located in Italy, Ireland and the United States.
97
22. Concentration of Credit Risk
Product Line Concentration
The percentage of total revenue recognized, which individually accounted for 10% or more of the Company’s total revenues in
one or more of the periods presented below, was as follows:
(in thousands)
Year Ended December 31,
2018 (1)
2017 (1)
2019 (1)
kaléo ..................................................................................................................
Merck.................................................................................................................
Biogen................................................................................................................
LENSAR............................................................................................................
—%
—%
—%
100%
—%
—%
14%
77%
16%
21%
40%
17%
________________
(1) The amounts above exclude product sales in our Pharmaceutical segment and royalty rights classified as held for sale in
the Income Generating Assets segment, each of which is included in the Statements of Operations as (Loss) income from
discontinued operations. See Note 3, Discontinued Operations Classified as Assets Held for Sale, for additional
information.
Total revenues by geographic area are based on the country of domicile of the counterparty to the agreement are as follows:
(in thousands)
Year Ended December 31,
2018
2017
2019
United States......................................................................................................
Europe................................................................................................................
Rest of world .....................................................................................................
Total revenues (1)...........................................................................................
________________
(1) The amounts above exclude product sales in our Pharmaceutical segment and royalty rights held for sale in the Income
12,117
30,706
21,434
15,151
32,028
8,143
2,451
3,438
$
$
$
$
$
$
2,732
5,424
83,143
91,299
Generating Assets segment, each of which is included in the Statements of Operations as (Loss) income from discontinued
operations. See Note 3, Discontinued Operations Classified as Assets Held for Sale, for additional information.
One customer accounted for more than 10% of accounts receivable, net as of December 31, 2019. A separate customer accounted
for more than 10% of accounts receivable, net as of December 31, 2018.
23. Income Taxes
For financial reporting purposes, (loss) income before income taxes from continuing operations includes the following
components:
(in thousands)
Years Ended December 31,
2019
2018
2017
United States......................................................................................................
Foreign...............................................................................................................
Total ..............................................................................................................
$
$
(25,249) $
—
(25,249) $
(39,518) $
—
(39,518) $
28,756
—
28,756
98
The provision for income taxes from continuing operations for the years ended December 31, 2019, 2018 and 2017 consisted of
the following:
Year Ended December 31,
2018
2017
2019
(in thousands)
Current income tax expense (benefit)
Federal.........................................................................................................
State.............................................................................................................
Foreign ........................................................................................................
Total current ...........................................................................................
Deferred income tax (benefit) expense
Federal.........................................................................................................
State.............................................................................................................
Foreign ........................................................................................................
Total deferred .........................................................................................
Total provision .................................................................................................
$
$
3,750
$
2,134
—
5,884
(7,830)
925
—
(6,905)
(1,021) $
(271) $
1,033
—
762
(7,932)
(615)
1,032
(7,515)
(6,753) $
12,596
1,289
—
13,885
671
848
—
1,519
15,404
A reconciliation of the income tax provision from continuing operations computed using the U.S. statutory federal income tax rate
compared to the income tax provision for income from continuing operations included in the Consolidated Statements of
Operations is as follows:
(in thousands)
Tax at U.S. statutory rate on (loss) income before income taxes.....................
Change in valuation allowance ........................................................................
State taxes ........................................................................................................
Change in uncertain tax positions ....................................................................
Foreign income ................................................................................................
Foreign rate differential ...................................................................................
Change in tax rate reform ................................................................................
True-ups ...........................................................................................................
Other ................................................................................................................
Total.............................................................................................................
$
$
Year Ended December 31,
2018
2017
2019
(5,302) $
(755)
2,545
1,513
—
—
—
249
729
(1,021) $
(8,299) $
875
(397)
809
—
—
—
(27)
286
(6,753) $
10,065
1,807
785
681
—
—
3,981
—
(1,915)
15,404
99
Deferred tax assets and liabilities are determined based on the differences between financial reporting and income tax bases of
assets and liabilities, as well as net operating loss carryforwards and are measured using the enacted tax rates and laws in effect
when the differences are expected to reverse. The significant components of the Company’s net deferred tax assets and liabilities
from continuing operations are as follows:
(in thousands)
Deferred tax assets:
December 31,
2019
2018
Net operating loss carryforwards............................................................................................
Research and other tax credits ................................................................................................
Intangible assets......................................................................................................................
Stock-based compensation......................................................................................................
Accruals ..................................................................................................................................
Debt modifications..................................................................................................................
Capital loss carryforward........................................................................................................
Other .......................................................................................................................................
Total deferred tax assets ..............................................................................................................
Valuation allowance.....................................................................................................................
Total deferred tax assets, net of valuation allowance ..................................................................
Deferred tax liabilities:
$
3,602
$
1,448
—
1,758
1,388
7,189
1,213
9,564
26,162
(7,465)
18,697
Debt modifications..................................................................................................................
Intangible assets......................................................................................................................
Other .......................................................................................................................................
Total deferred tax liabilities.........................................................................................................
Net deferred tax liabilities ...........................................................................................................
$
(308)
(19,649)
(311)
(20,268)
(1,571) $
2,384
1,580
—
1,106
825
4,661
1,866
6,579
19,001
(1,887)
17,114
(2,981)
(28,214)
—
(31,195)
(14,081)
As of December 31, 2019 and 2018, the Company had federal net operating loss carryforwards of $108.6 million and $101.7
million, respectively. As of December 31, 2019 and 2018, the Company also had state net operating loss carryforwards of $63.9
million and $70.8 million, respectively, excluding $215.5 million of California net operating losses available to offset
assessments, if any, resulting from the current audit by the California Franchise Tax Board. The federal and state net operating
loss carryforwards will begin expiring in the year 2023, if not utilized. As of December 31, 2019 and 2018, the Company had $2.2
million of federal tax credits that will begin expiring in the year 2025, if not utilized. As of December 31, 2019 and 2018, the
Company had $19.3 million of state tax credit carryforwards that do not expire. As of December 31, 2019 and 2018, the Company
had $125.6 million and $73.0 million, respectively, of net operating loss carryforwards in Ireland that do not expire.
Utilization of the federal and state net operating loss and tax credit carryforwards may be subject to a substantial annual limitation
due to the “change in ownership” provisions of the Internal Revenue Code of 1986. The annual limitation may result in the
expiration of net operating losses and credits before utilization. Of the Company’s $108.6 million of federal net operating loss
carryforwards as of December 31, 2019, $28.7 million are subject to an annual limitation of $1.8 million for each of the years
ending December 31, 2019 to 2022, and $1.3 million for the year ending December 31, 2023. As of December 31, 2019, the
Company estimates that at least $22.0 million of federal net operating loss carryforwards and none of the state net operating
losses will expire unutilized. Tax attributes acquired from LENSAR may be subject to separate return limitations that may limit
the corporation’s ability to use the acquired net operating losses and credits. Furthermore, under the 2017 Tax Act, although the
treatment of tax losses generated in taxable years ending before December 31, 2017 has not changed, tax losses generated in
taxable years beginning after December 31, 2017 may only be utilized to offset 80% of taxable income annually. This change may
require the Company to pay additional federal income taxes in future years if additional losses are generated post 2017.
As of December 31, 2019, the Company determined that it was more likely than not that certain deferred tax assets from
continuing operations would not be realized in the near future and had a $7.5 million valuation allowance against deferred tax
assets from continuing operations. The net change in total valuation allowance for each of the years ending December 31, 2019
and 2018, was an increase of $5.6 million and a decrease of $0.1 million, respectively. $1.2 million of the valuation allowance at
December 31, 2019, is related to capital losses that have limited carryforward utilization. The Company does not have an
expectation of future capital gains against which such losses could be utilized and as such determined that it was more likely than
100
not that such deferred tax assets would not be realized. $6.2 million of the valuation allowance at December 31, 2019 is related to
federal and state deferred tax assets that the Company determined it was more likely than not would be realized.
The cumulative amount of earnings of our foreign subsidiaries are expected to be permanently invested in the foreign subsidiaries.
Deferred taxes have not been provided on the excess of book basis over tax basis, or the excess tax basis over book basis in the
shares of our foreign subsidiaries because these basis differences are not expected to reverse in the foreseeable future and are
essentially permanent in duration. Our intention is to reinvest the earnings of the foreign subsidiaries indefinitely.
The Tax Cuts and Job Act of 2017 significantly changed the existing U.S. corporate income tax laws by, among other things,
lowering the corporate tax rate (from a top rate of 35% to a flat rate of 21%), implementing elements of a territorial tax system,
and imposing a one-time deemed repatriation transition tax on cumulative undistributed foreign earnings, for which the Company
has not previously paid U.S. taxes.
A reconciliation of the Company’s unrecognized tax benefits, excluding accrued interest and penalties, for 2019, 2018 and 2017 is
as follows:
(in thousands)
Balance at the beginning of the year .................................................................
Increases related to tax positions from prior fiscal years .............................
Increases related to tax positions taken during current fiscal year ...............
Decreases related to tax positions from prior fiscal years
Balance at the end of the year............................................................................
$
2019
December 31,
2018
2017
$
80,783
$
79,179
$
59,429
3,927
—
(497)
84,213
$
1,604
—
—
80,783
$
783
18,967
—
79,179
The future impact of the unrecognized tax benefit of $84.2 million, if recognized, is as follows: $27.9 million would affect the
effective tax rate and $56.3 million would result in adjustments to deferred tax assets and valuation allowances. The Company
periodically evaluates its exposures associated with our tax filing positions. The Company is currently under audit by the
California Franchise Tax Board and the Internal Revenue Service. The timing of the audit resolution and the amount to be
ultimately paid (if any) is uncertain. The outcome of these audits could result in the payment of tax amounts that differ from the
amounts the Company has reserved for uncertain tax positions for the periods under audit resulting in incremental expense or a
reversal of the Company’s reserves in a future period. At this time, the Company does not anticipate a material change in the
unrecognized tax benefits related to the California or Internal Revenue Service audits that would affect the effective tax rate,
deferred tax assets or valuation allowances over the next 12 months.
Estimated interest and penalties associated with unrecognized tax benefits increased our income tax expense in the Consolidated
Statements of Operations by $1.6 million, during the year ended December 31, 2019 and $1.0 million during each of the years
ended December 31, 2018 and 2017, respectively. In general, our income tax returns are subject to examination by U.S. federal,
state and local tax authorities for tax years 2000 forward. Interest and penalties associated with unrecognized tax benefits accrued
on the balance sheet were $9.7 million and $8.0 million as of December 31, 2019 and 2018, respectively. The Company is
currently under income tax examination by the State of California for the tax years 2009 through 2015 and by the Internal
Revenue Service for the tax year 2016.
101
24. Net (Loss) Income per Share
Net (Loss) Income per Basic and Diluted Share
(in thousands, except per share amounts)
Numerator
Year Ended December 31,
2018
2017
2019
Net (loss) income from continuing operations ............................................ $
Net (loss) income from discontinued operations......................................... $
(24,228) $
(46,463) $
(32,765) $
(36,094) $
13,352
97,349
(Loss) income attributable to the PDL’s stockholders used to compute net
(loss) income per basic and diluted share......................................................... $
(70,411) $
(68,859) $
110,748
Denominator
Total weighted-average shares used to compute net (loss) income
attributable to PDL's stockholders, per basic share..........................................
Effect of dilutive stock options....................................................................
Restricted stock outstanding........................................................................
Shares used to compute net (loss) income attributable to PDL’s
stockholders, per diluted share ...............................................................
118,631
145,669
155,394
—
—
—
—
—
863
118,631
145,669
156,257
Net (loss) income per share - basic
Continuing operations ................................................................................. $
Discontinued operations .............................................................................. $
Net (loss) income attributable to PDL’s stockholders per basic share ............. $
Net (loss) income per share - diluted
Continuing operations ................................................................................. $
Discontinued operations .............................................................................. $
Net (loss) income attributable to PDL’s stockholders per diluted share .......... $
(0.20) $
(0.39) $
(0.59) $
(0.20) $
(0.39) $
(0.59) $
(0.22) $
(0.25) $
(0.47) $
(0.22) $
(0.25) $
(0.47) $
0.09
0.62
0.71
0.09
0.62
0.71
The Company computes net (loss) income per diluted share using the sum of the weighted-average number of common and
common equivalent shares outstanding common equivalent shares used in the computation of net (loss) income per diluted share
include shares that may be issued pursuant to outstanding stock options and restricted stock awards in each case, on a weighted-
average basis for the period they were outstanding, including, if applicable, the underlying shares using the treasury stock method.
The February 2018 Notes that were repaid on February 1, 2018, the December 2021 Notes and the December 2024 Notes allow,
or previously allowed, for the settlement entirely or partially in cash, and are accounted for under the treasury stock method.
Under the treasury stock method, the shares issuable upon conversion of the notes are not included in the calculation of diluted
earnings per share except to the extent that the conversion value of the notes exceeds their principal amount. The effect of which,
for diluted earnings per share purposes, is that only the number of shares of common stock that would be necessary to settle such
excess, if the Company elected to settle such excess in shares, are included in the computation.
December 2021 Notes and December 2024 Notes Capped Call Potential Dilution
In November 2016, the Company issued $150.0 million in aggregate principal of the December 2021 Notes. In September 2019,
the Company entered into the September Exchange Transaction through which it exchanged a portion of the December 2021
Notes for the December 2024 Notes. Both the December 2021 Notes and the December 2024 Notes provide in certain situations
for the conversion of the outstanding principal amount into shares of the Company’s common stock at a predefined conversion
rate. In conjunction with the issuance of the December 2021 Notes and the issuance of the December 2024 Notes pursuant to the
September Exchange Transaction, the Company entered into capped call transactions, with a hedge counterparty. The capped call
transactions are expected generally to reduce the potential dilution, and/or offset, to an extent, the cash payments the Company
may choose to make in excess of the principal amount, upon conversion of the December 2021 Notes or the December 2024
Notes. The Company has excluded the capped call transaction from the net (loss) income per diluted share computation as such
securities would have an anti-dilutive effect and those securities should be considered separately rather than in the aggregate in
determining whether their effect on net (loss) income per diluted share would be dilutive or anti-dilutive. For additional
102
information regarding the conversion rates and the capped call transactions related to the Company’s December 2021 Notes and
December 2024 Notes; see Note 14, Convertible Senior Notes.
Anti-Dilutive Effect of Restricted Stock Awards and Stock Options
For the years ended December 31, 2019, 2018 and 2017, the Company excluded approximately 1,013,000, 1,139,000, and
1,830,000 shares, respectively, underlying restricted stock awards, calculated on a weighted-average basis, from it’s net (loss)
income per diluted share calculations because their effect was anti-dilutive.
For the years ended December 31, 2019, 2018 and 2017, the Company excluded approximately 11,192,000, 3,892,000 and
502,000 shares underlying outstanding stock options, respectively, calculated on a weighted-average basis, from the Company’s
net (loss) income per diluted share calculations because their effect was anti-dilutive.
25. Business Combinations
LENSAR TRANSACTION
Description of the LENSAR Transaction
In December 2016, LENSAR filed the Chapter 11 case with the support of the Company, as its largest senior secured creditor
under a credit agreement, as amended, that the Company and LENSAR had entered into in 2013. For more information regarding
the credit agreement between the Company and LENSAR, please see Note 8, Notes and Other Long-Term Receivables. In January
2017, the Company agreed to provide debtor-in-possession financing of up to $2.8 million in new advances to LENSAR so that it
could continue to operate its business during the remainder of the Chapter 11 case. As part of the Chapter 11 case, LENSAR filed
a Chapter 11 plan of reorganization, with the Company’s support, under which LENSAR would issue 100% of its equity securities
to the Company in exchange for the cancellation of the Company’s claims as a secured creditor in the Chapter 11 case. Following
consummation of the Chapter 11 plan of reorganization, LENSAR would become an operating subsidiary of the Company and the
Company provided LENSAR a new, senior-secured, first-priority term loan facility (the “Exit Facility”).
On April 26, 2017, the bankruptcy court approved the plan of reorganization. On May 11, 2017, LENSAR and the Company
consummated the plan of reorganization and LENSAR emerged from bankruptcy. Pursuant to the plan of reorganization, the
Company obtained control of 100% of the outstanding voting shares of LENSAR. All assets of the LENSAR bankruptcy estate
re-vested in reorganized LENSAR free and clear of all liens, claims or charges. Upon consummation of the plan of reorganization,
all debt owed to the Company was eliminated other than the Exit Facility. Liabilities to other creditors, including general
unsecured creditors, were satisfied through the plan of reorganization.
The Company concluded that the LENSAR transaction should be accounted for by applying the acquisition method in accordance
with ASC 805 that did not involve a transfer of consideration (“combinations by contract”).
Fair Value of Consideration Transferred
Contemporaneously with the cancellation of the Company’s notes receivable with a carrying value of $43.9 million, the Company
acquired 100% equity interests in LENSAR, at fair value, for $31.7 million resulting in a loss on extinguishment of notes
receivable of $10.6 million. The fair value of the equity interest in LENSAR was determined primarily using the “income
method,” which starts with a forecast of all expected future cash flows of the acquired business. The acquisition resulted in a gain
on bargain purchase because the fair value of assets acquired and liabilities assumed exceeded the total of the fair value of the
equity interest in LENSAR by approximately $9.3 million, net of loss on extinguishment of notes receivables, which was
recorded in the Consolidated Statement of Operations for the year ended December 31, 2017.
103
Assets Acquired and Liabilities Assumed
The following table summarizes the fair values of the identifiable intangible assets acquired and liabilities assumed at the
acquisition date:
(in thousands)
Amount
Cash..............................................................................................................................................................................
Tangible assets .............................................................................................................................................................
Intangible assets 1.........................................................................................................................................................
Net deferred tax assets .................................................................................................................................................
Total identifiable assets...........................................................................................................................................
Current liabilities .........................................................................................................................................................
Total liabilities assumed..........................................................................................................................................
$
1,983
18,647
11,970
25,723
58,323
(6,673)
(6,673)
Net loss on derecognition of notes receivables............................................................................................................
Gain on bargain purchase, net of loss on extinguishment of notes receivable ............................................................
Total fair value of consideration .............................................................................................................................
(10,615)
(9,309)
$
31,726
______________
1 As of the effective date of the transaction, identifiable intangible assets are required to be measured at fair value. The
fair value measurement is based on significant inputs that are unobservable in the market and thus represents a Level 3
measurement. The Company used an income approach to estimate the preliminary fair value of the intangibles which
includes technology, trademarks and customer relationships. The assumptions used to estimate the cash flows of the
business included a discount rate of 16%, estimated gross margins ranging from 37-72%, income tax rate of 35%, and
operating expenses consisting of direct costs based on the anticipated level of revenues. The intangible assets have a
weighted-average useful life of approximately 15 years. The intangible assets for acquired technology and trademarks
are being amortized over their estimated useful lives using the straight-line method of amortization. The intangible
assets for customer relationship are being amortized using a double-declining method of amortization as such method
better represents the economic benefits to be obtained.
26. Legal Proceedings
PDL BioPharma, Inc. v Merck Sharp & Dohme, Corp.
On January 22, 2016, the Company filed a complaint against Merck Sharp & Dohme, Corp (“Merck”) for patent infringement in
the United States District Court for the District of New Jersey. In the complaint, the Company alleged that manufacture and sales
of certain of Merck’s Keytruda product infringed one or more claims of the Company’s U.S. Patent No. 5,693,761 (the “761
Patent”). The Company requested judgment that Merck infringed the 761 Patent, an award of damages due to the infringement, a
finding that such infringement was willful and deliberate and trebling of damages therefore, and a declaration that the case is
exceptional and warrants an award of attorney’s fees and costs.
On April 21, 2017, the Company entered into a settlement agreement with Merck to resolve the patent infringement lawsuit
between the parties pending in the U.S. District Court for the District of New Jersey related to Merck’s Keytruda humanized
antibody product. Under the terms of the agreement, Merck paid the Company a one time, lump-sum payment of $19.5 million,
and the Company granted Merck a fully paid-up, royalty free, non-exclusive license to certain of the Company’s rights to issued
patents in the United States and elsewhere, covering the humanization of antibodies (the “Queen et al. patent”) for use in
connection with Keytruda as well as a covenant not to sue Merck for any royalties regarding Keytruda. In addition, the parties
agreed to dismiss all claims in the relevant legal proceedings.
Wellstat Litigation
On September 4, 2015, the Company filed in the Supreme Court of New York a motion for summary judgment in lieu of
complaint which requested that the court enter judgment against Wellstat Diagnostics Guarantors for the total amount due on the
Wellstat Diagnostics debt, plus all costs and expenses including lawyers’ fees incurred by the Company in enforcement of the
related guarantees. On July 29, 2016, the court issued its Memorandum of Decision granting the Company’s motion for summary
judgment and denying the Wellstat Diagnostics Guarantors’ cross-motion for summary judgment seeking a determination that
104
they were no longer liable under the guarantees. The Supreme Court of New York held that the Wellstat Diagnostics Guarantors
are liable for all “Obligations” owed by Wellstat Diagnostics to the Company. It did not set a specific dollar amount due, but
ordered that a judicial hearing officer or special referee be designated to determine the amount of the Obligations owing, and
awarded the Company its attorneys’ fees and costs in an amount to be determined. On July 29, 2016, the Wellstat Diagnostics
Guarantors filed a notice of appeal from the Memorandum of Decision to the Appellate Division of the Supreme Court of New
York. On February 14, 2017, the Appellate Division reversed the summary judgment decision of the Supreme Court in the
Company’s favor, but affirmed the denial of the Wellstat Diagnostics Guarantors’ cross-motion for summary judgment. The
Appellate Division determined that the action was inappropriate for summary judgment pursuant to New York Civil Practice Law
& Rules section 3213 on procedural grounds, but specifically made no determination regarding whether the Company was
entitled to a judgment on the merits. Pursuant to this decision, the action was remanded to the Supreme Court for further
proceedings on the merits. The proceeding has been conducted as a plenary proceeding, with both parties having the opportunity
to take discovery and file dispositive motions in accordance with New York civil procedure. On September 11, 2019, the Supreme
Court of New York granted the Company’s summary judgment motion, the court holding that the guarantees executed by the
Wellstat Diagnostics Guarantors are valid and enforceable, and that the Wellstat Diagnostics Guarantors are liable for the amount
owed under the loan agreement. The court ordered a damages hearing before a special referee to calculate the amount owed under
the loan agreement between Wellstat Diagnostics and the Company. On September 12, 2019, the Wellstat Diagnostics Guarantors
filed a notice of appeal of the Supreme Court of New York’s decision on summary judgment. On September 17, 2019, the Wellstat
Diagnostics Guarantors requested a stay of the enforcement of the New York Supreme Court’s decision pending their appeal of
the decision, which was denied on November 21, 2019. A damages hearing was scheduled to begin before a judicial hearing
officer on December 17, 2019. At the request of the judicial hearing officer, the parties agreed to mediate their dispute prior to the
commencement of the damages hearing. As a result, no decision has been made by the hearing officer with respect to the amount
of damages owed to the Company.
Glumetza Class Action Antitrust Litigation
On September 18, 2019, the City of Providence filed a civil antitrust suit on behalf of a putative class of payors in the Northern
District of California against Bausch Health Companies, Inc., Salix Pharmaceuticals, Inc., Santarus, Inc., Assertio Therapeutics,
Inc., Lupin Pharmaceuticals, Inc. and the Company, inter alia, alleging that a patent settlement agreement between Assertio and
Lupin unlawfully restrained competition in an alleged market for Glumetza and its AB-rated generic equivalents sold in the
United States. The plaintiffs claim that the settlement agreement violated the federal Sherman Act and various state antitrust laws.
The Company was a named defendant by certain End Payor Plaintiffs (EPPs) due to its purchase from Assertio in 2013 of a
royalty asset based on sales of Glumetza. On January 21, 2020, the EPPs voluntarily dismissed their claims against the Company,
without prejudice. The Company has agreed to toll the running of statute of limitations for a limited period of time and to respond
to certain discovery requests, subject to reasonable objections.
Noden Pharma DAC v Anchen Pharmaceuticals, Inc. et al
On June 12, 2017, Noden Pharma DAC filed a complaint against Anchen and Par Pharmaceutical (“Par”) for infringement of U.S.
Patent No. 8,617,595 based on their submission of an ANDA seeking authorization from the FDA to market a generic version of
Tekturna® aliskiren hemifumarate tablets, 150 mg and 300 mg, in the United States. Noden Pharma DAC’s suit triggered a 30-
month stay of FDA approval of that application under the Hatch Waxman Act. Par filed a counterclaim seeking a declaratory
judgment that their proposed generic version of Tekturna HCT® aliskiren hemifumarate hydrochlorothiazide tablets (150 mg eq.
base/12.5 mg HCT, 150 mg eq. base/25 mg HCT, 300 mg eq. base/12.5 mg HCT, and 300 mg eq. base/25 mg HCT), described in
a separate ANDA submitted by Par to FDA, alleging noninfringement of U.S. Patent No. 8,618,172 (“the ‘172 Patent”), also
owned by Noden Pharma DAC. This case was litigated in the United States District Court for the District of Delaware. In March
of 2018, the Parties filed a joint stipulation of dismissal of the defendants’ counterclaim seeking a declaratory judgment of non-
infringement of the ‘172 Patent. In the stipulation, Anchen and Par agreed that they will not seek, or otherwise join or assist in,
any post-grant review, including inter partes review, of the ‘172 patent or U.S. Patent No. 9,023,893. The defendants further
stipulated that they will not seek marketing approval of Par’s ANDA or submit any other ANDA seeking approval to market
aliskiren hemifumarate hydrochlorothiazide prior to the expiration of the ‘172 Patent in July of 2028. Both the ‘172 Patent and the
‘893 Patent are listed in the Orange Book for Tekturna HCT. On June 8, 2018, Noden and Anchen entered into the Settlement
Agreement. Under the Settlement Agreement, the parties agreed to file a stipulation of dismissal with the court to facilitate
dismissal of the litigation in its entirety, with prejudice. In the Settlement Agreement, Noden granted Anchen a non-exclusive,
royalty free, fully paid up and non-transferable license to manufacture and commercialize in the United States a generic version of
aliskiren which is described in Anchen’s ANDA, and Anchen agreed not to commercialize its generic version of aliskiren prior to
March 1, 2019. The license grant excludes certain formulations covered by the ‘595 Patent which closely relate to the commercial
formulation of Tekturna marketed by Noden. The Settlement Agreement includes a release by each party for liabilities associated
with the litigation and an acknowledgment from Anchen that the ‘595 Patent claims are valid and enforceable.
105
Depomed, Inc. vs. Valeant Pharmaceuticals, Inc.
On October 27, 2017, Valeant, Depomed and the Company entered into a settlement agreement (“Depomed Settlement
Agreement”) to resolve all matters addressed in the lawsuit. Under the terms of the Depomed Settlement Agreement, the litigation
was dismissed, with prejudice, and Valeant paid to Depomed a one-time, lump-sum payment of $13.0 million. In addition,
Depomed and the Company released Valeant and its subsidiary from any and all claims against them as a result of the audit,
Valeant’s obligation to pay additional royalties under the commercialization agreement and/or the litigation; and Valeant released
Depomed and the Company against any and all claims against them as a result of the audit and/or the litigation. The settlement
payment was transferred to the Company under the terms of the Depomed Royalty Agreement in November of 2017.
Other Legal Proceedings
From time to time, the Company is involved in lawsuits, arbitrations, claims, investigations and proceedings, consisting of
intellectual property, commercial, employment and other matters, which arise in the ordinary course of business. The Company
makes provisions for liabilities when it is both probable that a liability has been incurred and the amount of the loss can be
reasonably estimated. Such provisions are reviewed at least quarterly and adjusted to reflect the impact of settlement negotiations,
judicial and administrative rulings, advice of legal counsel, and other information and events pertaining to a particular case.
Litigation is inherently unpredictable. If any unfavorable ruling were to occur in any specific period, there exists the possibility of
a material adverse impact on the results of the Company’s operations of that period and on its cash flows and liquidity.
27. Subsequent Events
Repurchase Program
From January 1, 2020 to March 10, 2020, the Company repurchased approximately 3.8 million shares of its common stock at a
weighted-average price of $3.42 per share for a total of $12.9 million and repurchased $3.2 million in aggregate principal amount
of December 2021 Convertible Notes and $10.5 million in aggregate principal amount of December 2024 Convertible Notes.
Amendment to CareView Modification Agreement
As further discussed in Note 8, Notes and Other Long-Term Receivables, to the Consolidated Financial Statements, in January
2020 we entered into an amendment of the February 2018 Modification Agreement with CareView that deferred principal
repayment and interest payments until April 30, 2020, conditioned upon CareView raising additional financing from third parties.
Plan of Liquidation
In December 2019, the Company announced that it had completed a strategic review process and decided to halt the execution of
its growth strategy, cease additional strategic transactions and investments and pursue a formal process to unlock value by
monetizing its assets and returning net proceeds to stockholders. Over the subsequent months, the Company’s board of directors
and management analyzed, together with outside financial and legal advisors, how to best capture value pursuant to its
monetization strategy and return the significant intrinsic value of the high-quality assets in its portfolio to its stockholders. On
February 7, 2020, the Company’s board of directors approved a plan of complete liquidation for the Company’s assets and a
resolution to seek stockholder approval to dissolve the Company at its next annual meeting of the stockholders.
Pursuant to the board’s decisions of February 7, 2020, noted above, the change in control clause in the Amended 2005 Equity
Incentive Plan was triggered, accelerating the vesting of a significant portion of the Company’s outstanding equity awards
resulting in incremental stock-based compensation expense of $16.3 million to be recorded in the first quarter of 2020.
Events Subsequent to Original Issuance of Financial Statements (Unaudited)
Repurchase Program
From March 11, 2020 to June 29, 2020, the Company repurchased approximately 8.6 million shares of its common stock at a
weighted-average price of $3.09 per share for a total of $26.5 million and repurchased $2.2 million in aggregate principal amount
of December 2021 Convertible Notes.
106
Evofem Share Distribution
On May 21, 2020 the Company announced that it had completed the distribution of all of the Company’s 13,333,334 shares of
common stock of Evofem Biosciences, Inc. to the Company’s shareholders, which represented approximately 26.7% of the
outstanding shares of Evofem common stock as of the close of business on May 15, 2020. Following the Distribution, PDL
continues to hold warrants to purchase up to 3,333,334 shares of Evofem common stock. The warrants are included in Other
Assets on the consolidated balance sheet and had a carrying value of $14.1 million at December 31, 2019. The distribution was
made in the form of a pro rata common stock dividend of 0.11591985 shares of Evofem common stock for every share of PDL
common stock. As of December 31, 2019, the Evofem common stock was valued at $82.3 million.
AcelRx
On May 22, 2020, the Company was notified by AcelRx that the product marketer of Zalviso, Grünenthal GmbH, has terminated
the license agreement with AcelRx. AcelRx is obligated to use commercially reasonable efforts to find a new license agreement
under the terms no less favorable than those in the license with Grünenthal. The Company believes that the asset is impaired and
estimates that unless and until the drug is relicensed the fair value will be substantially reduced. As of December 31, 2019, the
AcelRx fair value was $13.0 million and an impairment charge of approximately $13.0 million will be recorded in the three
months period ended June 30, 2020.
PDL Parental Financial Support Guarantee for LENSAR
On June 19, 2020, PDL issued a letter guaranteeing financial support to LENSAR up to $20 million through June 20, 2021.
COVID-19 Pandemic
In March 2020, the World Health Organization declared the outbreak of a novel coronavirus (“COVID-19”) pandemic. The
outbreak of the COVID-19 pandemic is significantly affecting the Company’s LENSAR business operations, as well as the U.S.
economy and financial markets. At this time, it doesn’t appear that our other segments have been significant impacted by the
pandemic. The full extent to which the COVID-19 outbreak will impact the Company’s business, results of operations, financial
condition and cash flows will depend on future developments that are highly uncertain and the estimates of the impact on the
Company’s business may change based on new information that may emerge concerning COVID-19 and the actions to contain
it or treat its impact and the economic impact on local, regional, national and international markets. While the Company cannot
provide a definitive timeline for the liquidation process, it has been targeting the end of 2020 for completing the monetization of
its key assets. However, the Company recognizes that the duration and extent of the public health issues related to the
COVID-19 pandemic make it possible, and perhaps probable, that the timing may be delayed.
28. Quarterly Financial Data (Unaudited)
(in thousands, except per share data)
Three Months Ended
December 31,
2019
September 30,
2019
June 30,
2019
March 31,
2019
Total revenues.................................................................
Net (loss) income from continuing operations ...............
Net (loss) income from discontinued operations............
Net (loss) income attributable to PDL’s stockholders ....
Net income (loss) from continuing operations per basic
share ...............................................................................
Net income (loss) from discontinued operations per
basic share ......................................................................
Net income (loss) from continuing operations per
diluted share ...................................................................
Net income (loss) from discontinued operations per
diluted share ...................................................................
Net (loss) income per basic share...................................
Net (loss) income per diluted share................................
$
$
$
$
$
$
$
$
$
$
(29,846) $
(10,069) $
(44,761) $
(54,888) $
44,165
$
(29,919) $
11,954
$
(17,784) $
(22,526) $
$
24,212
(28,725) $
(4,419) $
38,913
(8,452)
15,069
6,680
(0.09) $
(0.26) $
0.21
$
(0.07)
(0.39) $
0.10
$
(0.25) $
0.12
(0.09) $
(0.26) $
0.20
$
(0.07)
(0.39) $
(0.48) $
(0.48) $
0.10
$
(0.16) $
(0.16) $
(0.24) $
(0.04) $
(0.04) $
0.05
0.05
0.05
107
(in thousands, except per share data)
Three Months Ended
December 31,
2018
September 30,
2018
June 30,
2018
March 31,
2018
Total revenues ................................................................
Net (loss) income from continuing operations...............
Net (loss) income from discontinued operations ...........
Net income (loss) attributable to PDL’s stockholders....
Net income (loss) from continuing operations per
basic share......................................................................
Net income (loss) from discontinued operations per
basic share......................................................................
Net income (loss) from continuing operations per
diluted share ...................................................................
Net income (loss) from discontinued operations per
diluted share ...................................................................
Net income (loss) per basic share ..................................
Net income (loss) per diluted share ...............................
$
$
$
$
$
$
$
$
$
$
$
7,146
(10,190) $
$
26,468
16,279
$
$
7,942
(8,624) $
$
34,180
25,556
$
$
7,855
(9,116) $
(103,180) $
(112,296) $
9,085
(4,835)
6,438
1,602
(0.07) $
(0.06) $
(0.06) $
(0.03)
0.19
$
0.24
$
(0.70) $
0.04
(0.07) $
(0.06) $
(0.06) $
(0.03)
0.19
0.12
0.12
$
$
$
0.24
0.18
0.18
$
$
$
(0.70) $
(0.76) $
(0.76) $
0.04
0.01
0.01
108
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Corporate Directory
Senior Leadership Team
Board of Directors
Dominique P. Monnet
President and
Chief Executive Officer
Edward A. Imbrogno
Vice President and
Chief Financial Officer
Jill M. Jene, Ph.D.
Vice President,
Business Development
Christopher L. Stone
Vice President and
General Counsel
Elizabeth G. O'Farrell
Chairman, PDL BioPharma, Inc.
Former Chief Procurement Officer
Eli Lilly and Company
Alan L. Bazaar
Chief Executive Officer Hallow Brook
Wealth Management LLC.
David W. Gryska
Former Executive Vice President
and Chief Financial Officer
Incyte Corporation
Natasha A. Hernday
Sr. Vice President, Corporate
Development Seattle Genetics, Inc.
John P. McLaughlin
Former Chief Executive Officer PDL
BioPharma, Inc.
Dominique P. Monnet
President and
Chief Executive Officer
PDL BioPharma, Inc.
Paul W. Sandman
Former General Counsel
Boston Scientific Corporation
Corporate Headquarters
PDL BioPharma, Inc.
932 Southwood Blvd.
Incline Village, NV 89451
For More Information
775.832.8500
775.832.8501
ir@pdl.com
Tel:
Fax:
Email:
www.PDL.com
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©2020 PDL BioPharma, Inc. All rights reserved.
This annual Report contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E
of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts are “forward looking statements” for
purposes of these provisions, including any projections of earnings, revenues or other financial items, any statements of the plans and objectives of
management for future operations, any statements regarding future economic conditions or performance, and any statement of assumptions underlying
any of the foregoing in some cases, forward-looking statements can be identified by the use of terminology such as “may,” “will,” “intends,” “plans,”
“believes,” “anticipates,” “expects,” “estimates,” “predicts,” “potential,” “ continue” or “opportunity,” or the negative thereof or other comparable
terminology. Although we believe that the expectations presented in the forward-looking statements contained herein are reasonable, there can be no
assurance that such expectations or any of the forward-looking statements will prove to be correct, and actual results could differ materially from those
projected or assumed in the forward-looking statements. Our future financial condition and results of operations, as well as any forward-looking
statements, are subject to inherent risks and uncertainties, including but not limited to the risk factors set forth below, and for the reasons described
elsewhere in this Annual Report. All forward-looking statements and reasons why results may differ included in this Annual Report are made as of the
date hereof, and we assume no obligation to update these forward-looking statements or reasons why actual results may differ.
BR69329Y-0720-COMBO