2016
ANNUAL REPORT
ANIKA THERAPEUTICS, INC.
Anika Therapeutics, Inc.
2016 Letter to Shareholders
Dear Anika Shareholders,
Anika’s 2016 was another year of strong growth and financial performance, fueled by commercial, regulatory, and business
achievements throughout the year. End-user demand for our core product platforms continued to grow, and strong execution by our
distribution partners resulted in robust product revenue growth for the year. Orthovisc and Monovisc continued to maintain a
combined market leading position in the U.S., and we delivered substantial international growth driven primarily by the global
expansion of Monovisc and the promising launch of Cingal in select countries.
As we look to 2017 and beyond, we expect that Monovisc will continue to gain market share, both domestically and internationally, as
end users naturally migrate to it from Orthovisc. This migration of share capture within our viscosupplementation franchise, which we
expect to accomplish while avoiding the large revenue swings faced by other companies, is a hallmark of Anika’s culture of
innovation. Our strategy is to remain in a position to lead and benefit from technology advances instead of falling victim to such
circumstances. We anticipate that the introduction of Cingal to the market will usher in another migration, except in this case we
anticipate that the breakthrough nature of the product will result in expansion in the overall market for our products. Our company is
currently at an inflection point as we look out to our next wave of growth, which will be marked by the introduction of new products,
supported by our deep and differentiated pipeline, and magnified by our fiscal and operational discipline.
2016 Financial Results
In 2016, product revenue increased 17% to $102.9 million, driven primarily by strong returns from Orthovisc and Monovisc.
Worldwide Orthobiologics revenue increased 22% in 2016, and Orthobiologics revenue from international sales increased 24% for the
year. The major product revenue growth driver for the year was a 54% increase in worldwide Monovisc revenue. We also delivered a
strong product gross margin of 77% and an operating margin of 49% for 2016. Net income totaled $32.5 million and diluted earnings
per share was $2.15 for the year.
We generated solid operating cash flow of $24 million for 2016, and ended the year with approximately $125 million in cash, cash
equivalents, and short-term investments. We also returned value to our shareholders through a $25 million accelerated share
repurchase program, which was completed in August. We expect that we will continue to generate strong cash from operations in
2017, and we have the opportunity to accelerate our growth in the years ahead by making strategic investments as we move forward.
Executing Long-Term Growth Strategy
Our vision is to develop a portfolio of Orthobiologics products to serve the needs of orthopedic surgeons and their patients across a
wide range of palliative, restorative, and regenerative indications. To achieve this vision, our strategic objectives in 2016 were focused
on global commercial expansion, pipeline advancement, infrastructure enhancements, and assessing strategic M&A. All of these
activities were undertaken to drive the sustained growth of our company and to create value for our patients and shareholders.
The first pillar of our long-term growth strategy is geographic expansion. We currently have active commercial relationships in over
55 countries, and we continually pursue new avenues to expand our global presence. Last year, we launched Cingal in Canada and
nine European countries, which added to the strength of our product portfolio in those geographies. The successful Cingal launches in
Canada and Europe gives us additional confidence and data that indicate Cingal will be well received and adopted by physicians and
patients as we march into new geographies. To this point, we are currently advancing regulatory and commercial activities for Cingal,
as well as Monovisc, in territories such as India and Australia, and we remain focused on bringing these products into new
international markets. As we have discussed previously, the company also submitted an Investigational New Drug application to the
U.S. Food and Drug Administration to initiate an additional Phase III clinical trial to verify and supplement our existing strong pivotal
data on Cingal, and we commenced this trial in the first quarter of 2017. In the fourth quarter of 2016, we received CE Mark approval
for a new treatment indicated to relieve pain and restore function in tendons affected by common repetitive overuse injuries such as
1
lateral epicondylitis, better known as tennis elbow. This treatment will be marketed internationally as Orthovisc-T, and it will
generally be distributed through our existing distributor network.
The second pillar of our long-term growth strategy is to advance our deep and differentiated pipeline of late-stage programs. In 2016,
we continued enrolling patients in our HyaloFast FastTRACK Phase III trial for cartilage repair, and we expect to accelerate
enrollment in this trial in 2017. We are collaborating with DePuy Synthes Mitek Sports Medicine, our U.S. commercial partner for
Orthovisc and Monovisc, to conduct a Phase III clinical trial with the goal of expanding Monovisc’s application to include the
treatment of osteoarthritis in the hip. Our goal is to be the first to market in the United States with this additional indication. We are
also committed to advancing our new product development programs into the later stages of clinical development. All global
expansion and product development and clinical programs undertaken by the company will be funded through cash realized from
operations.
In 2016, we made significant progress in strengthening our infrastructure, the third pillar of our growth strategy. We continued the
development of our own direct commercialization capability in the United States, and we will continue to build this capability
throughout 2017. The ability to go direct empowers Anika to own end user relationships, gives us access to key data, and provides us a
larger share of end user revenue. We completed the physical plant build-out required to consolidate our global manufacturing
operations at our Bedford, Massachusetts global headquarters, and we received regulatory approval of the product packaging
operations at this facility. Those operations are currently online producing aesthetically and functionally improved finished goods for
shipment around the globe. We expect to receive all additional regulatory approvals required to manufacture saleable products before
the end of this year. We anticipate that this project will allow us to gain better control of our supply chain, enhance our research and
development capabilities with the aim of accelerating future product development, and improve the efficiency of our manufacturing
process. In addition, we recently completed the build-out of our new European headquarters and training center in Padova, Italy, and
we moved our operations into the facility in mid-March 2017.
The fourth pillar of our growth strategy is strategic M&A. While we did not execute on any transactions in 2016, we evaluated
opportunities throughout the year. We are determined to maintain our focus on M&A, and we remained committed to evaluating and
potentially pursuing any and all options to accelerate our expansion and growth.
In summary, we made significant progress executing our growth strategy in 2016, and we entered 2017 in a very strong financial
position. Anika’s strategic objectives in the year ahead remain centered on global commercial expansion, pipeline advancement,
infrastructure enhancements, and strategic M&A with the overall goal of driving both near-term and long-term growth and creating
sustained value for our shareholders. Thank you for your continued trust and support.
Sincerely,
Charles H. Sherwood, Ph.D.
President and Chief Executive Officer
2
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2016
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 000-21326
Anika Therapeutics, Inc.
(Exact Name of Registrant as Specified in Its Charter)
Massachusetts
(State or Other Jurisdiction of Incorporation or Organization)
04-3145961
(IRS Employer Identification No.)
32 Wiggins Avenue, Bedford, Massachusetts 01730
(Address of Principal Executive Offices) (Zip Code)
(781) 457-9000
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class
Common Stock, par value $0.01 per share
Preferred Stock Purchase Rights
Name of Each Exchange on Which Registered
NASDAQ Global Select Market
NASDAQ Global Select Market
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes No
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past
90 days. Yes No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit and post such files). Yes No
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, or a smaller reporting company. See the definitions of
"large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act.
Large accelerated filer
Accelerated filer
Non-accelerated filer
(Do not check if a smaller
reporting company)
Smaller reporting company
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No
The aggregate market value of voting and non-voting equity held by non-affiliates of the Registrant (without admitting that any person whose shares are not
included in such calculation is an affiliate) as of June 30, 2016, the last day of the Registrant’s most recently completed second fiscal quarter, was $769,977,665 based on
the close price per share of common stock of $53.65 as of such date as reported on the NASDAQ Global Select Market. At February 21, 2017, there were issued and
outstanding 14,638,862 shares of common stock, par value $0.01 per share.
Documents Incorporated By Reference
The registrant intends to file a proxy statement pursuant to Regulation 14A within 120 days of the end of the fiscal year ended December 31, 2016. Portions of such proxy
statement are incorporated by reference into Part III of this Annual Report on Form 10-K.
ANIKA THERAPEUTICS, INC.
TABLE OF CONTENTS
Cautionary Note Regarding Forward-Looking Statements
Part I
Item 1. Business
Item 1A. Risk Factors
Item 1B. Unresolved Staff Comments
Item 2. Properties
Item 3. Legal Proceedings
Item 4. Mine Safety Disclosures
Part II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Item 6. Selected Financial Data
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Item 8. Financial Statements and Supplementary Data
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Item 9A. Controls and Procedures
Item 9B. Other Information
Part III
Item 10. Directors, Executive Officers and Corporate Governance
Item 11. Executive Compensation
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Item 13. Certain Relationships and Related Transactions, and Director Independence
Item 14. Principal Accounting Fees and Services
Part IV
Item 15. Exhibits and Financial Statement Schedules
Signatures
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71
References in this Annual Report on Form 10-K to “we,” “us,” “our,” “our company,” and other similar references refer to Anika
Therapeutics, Inc. and its subsidiaries unless the context otherwise indicates.
ANIKA, ANIKA THERAPEUTICS, ANIKAVISC, CINGAL, HYAFF, HYDRELLE, HYVISC, INCERT, MONOVISC, and
ORTHOVISC are our registered trademarks, and HYALOSS, OPTIVISC, and SHELLGEL are our trademarks. This Annual Report on
Form 10-K also contains registered marks, trademarks, and trade names that are the property of other companies and licensed to us.
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FORM 10-K
ANIKA THERAPEUTICS, INC.
For Fiscal Year Ended December 31, 2016
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This report contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 concerning our business, consolidated financial condition, and results of operations.
The Securities and Exchange Commission ("SEC") encourages companies to disclose forward-looking statements so that investors can
better understand a company’s future prospects and make informed investment decisions. Forward-looking statements are subject to
risks and uncertainties, many of which are outside our control, which could cause actual results to differ materially from these
statements. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements can be identified by
such words as "will," "likely," "may," "believe," "expect," "anticipate," "intend," "seek," "designed," "develop," "would," "future,"
"can," "could," and other expressions that are predictions of or indicate future events and trends and that do not relate to historical
matters. All statements other than statements of historical facts included in this report regarding our strategies, prospects, financial
condition, operations, costs, plans, and objectives are forward-looking statements. Examples of forward-looking statements include,
among others, statements regarding expected future operating results, expectations regarding the timing and receipt of regulatory results,
anticipated levels of capital expenditures, and expectations of the effect on our financial condition of claims, litigation, and
governmental and regulatory proceedings.
Please refer to "Risk Factors" for important factors that we believe could cause actual results to differ materially from those in
our forward-looking statements. Any forward-looking statement made by us in this Annual Report on Form 10-K is based only on
information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update
any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information,
future developments or otherwise.
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ITEM 1. BUSINESS
Overview
PART I
We are a global, integrated orthopedic medicines company committed to improving the lives of patients with degenerative
orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain
management to regenerative cartilage repair. We have over two decades of global expertise developing, manufacturing, and
commercializing products based on our proprietary hyaluronic acid (“HA”) technology. Our orthopedic medicine portfolio includes
ORTHOVISC, MONOVISC, and CINGAL, which alleviate pain and restore joint function by replenishing depleted HA, and
HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration.
Our therapeutic offerings consist of products in the following areas: Orthobiologics, Dermal, Surgical, and Other, which
includes our ophthalmic and veterinary products. All of our products are based on HA, a naturally occurring, biocompatible polymer
found throughout the body. Due to its unique biophysical and biochemical properties, HA plays an important role in a number of
physiological functions such as the protection and lubrication of soft tissues and joints, the maintenance of the structural integrity of
tissues, and the transport of molecules to and within cells.
Our proprietary technologies for modifying the HA molecule allow product properties to be tailored specifically to therapeutic
use. Our patented technology chemically modifies HA to allow for longer residence time in the body. We also offer products made from
HA based on two other technologies: HYAFF, which is a solid form of HA, and ACP gel, an autocross-linked polymer of HA. Our
technologies are protected by an extensive portfolio of owned and licensed patents.
Since our inception in 1992, we have utilized a commercial partnership model for the distribution of our products to end users.
Our strong, worldwide network of distributors has historically provided, and continues to provide, a solid foundation for our revenue
growth and territorial expansion. In 2015, we made the strategic decision to commercialize our next generation viscosupplementation
product, CINGAL, in the United States by utilizing a direct sales model, initially through the engagement of a contract sales
organization. Ultimately, we intend to transition the direct sales function into our company as part of a broader buildout of our
commercial capabilities. We believe that the combination of the direct and distribution commercial models will maximize the revenue
and profitability potential from our current and future product portfolio.
We began a strategic project in 2015 to move the manufacturing of our HYAFF-based products, which were previously
manufactured by a third party in Italy, to our Bedford, Massachusetts facility. Our main purposes behind this strategic move are to gain
control of supply chain management, to improve the efficiency of our manufacturing process, and to enhance our research and
development capabilities, with the aim of accelerating future product development.
The following sections provide more specific information about our products and related activities:
Orthobiologics
Our orthobiologics products primarily consist of viscosupplementation and regenerative orthopedic products. These products
are used in a wide range of treatments, from providing pain relief from osteoarthritis to regenerating damaged tissue such as cartilage.
Osteoarthritis is a debilitating disease causing pain, swelling, and restricted movement in joints. It occurs when the cartilage in a joint
gradually deteriorates due to the effects of mechanical stress, which can be caused by a variety of factors, including the normal aging
process. In an osteoarthritic joint, particular regions of articulating surfaces are exposed to irregular forces, which results in the
remodeling of tissue surfaces that disrupt the normal equilibrium or mechanical function. As osteoarthritis advances, the joint gradually
loses its ability to regenerate cartilage tissue, and the cartilage layer attached to the bone deteriorates to the point where eventually the
bone becomes exposed. Advanced osteoarthritis often requires surgery and the possible implantation of artificial joints. The current
treatment options for osteoarthritis, before joint replacement surgery, include viscosupplementation, analgesics, non-steroidal anti-
inflammatory drugs, and steroid injections.
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Our viscosupplementation franchise includes ORTHOVISC, ORTHOVISC mini, MONOVISC, and CINGAL. ORTHOVISC is
available in the United States, Canada, and other international markets for the treatment of osteoarthritis of the knee, and in Europe and
certain international markets for the treatment of osteoarthritis in all joints. ORTHOVISC mini is available in Europe, and it is designed
for the treatment of osteoarthritis in small joints. MONOVISC is our single injection osteoarthritis treatment indicated for all joints in
Europe and certain international markets, and for the knee in the United States, Turkey, and Canada. ORTHOVISC has been marketed
by us internationally since 1996, and it was approved by the FDA for sale in the United States in 2004. ORTHOVISC mini and
MONOVISC became available in certain international markets in the second quarter of 2008. MONOVISC was approved by the FDA
for sale in the United States in February 2014, and the related U.S. commercial introduction of the product occurred in April 2014. In the
United States, our viscosupplementation franchise, consisting of our ORTHOVISC and MONOVISC products, continues to maintain a
market leadership position. CINGAL, our second single-injection osteoarthritis product, received regulatory approval from Health
Canada in November 2015 for the treatment of pain associated with osteoarthritis of the knee. In March 2016, we received CE Mark
approval of CINGAL as a viscoelastic supplement or as a replacement for synovial fluid in human joints. We successfully achieved
commercial launch of the product in Canada during May 2016 and in the European Union during June 2016. Upon achievement, if any,
of such regulatory approval in the United States, we plan to commercialize the product through a direct sales model, initially through the
engagement of a contract sales organization, with the ultimate goal of transitioning the direct sales function into our company as part of
a broader buildout of our commercial capabilities. For additional information about CINGAL in the United States, see the section
captioned “Business—Research and Development of Potential Products.”
In the United States, ORTHOVISC is indicated for the treatment of pain caused by osteoarthritis of the knee in patients who
have failed to respond adequately to conservative, non-pharmacologic therapy and to simple analgesics, such as acetaminophen.
ORTHOVISC is a sterile, clear, viscous solution of hyaluronan dissolved in physiological saline and dispensed in a single-use syringe.
A complex sugar of the glycosaminoglycan family, hyaluronan is a high molecular weight polysaccharide composed of repeating
disaccharide units of sodium glucuronate and N-acetyl glucosamine. ORTHOVISC is injected into joints in a series of three intra-
articular injections one week apart. ORTHOVISC became available for sale in the United States on March 1, 2004, and it is marketed by
DePuy Synthes Mitek Sports Medicine (“Mitek”) under the terms of a ten-year licensing, distribution, supply, and marketing agreement
which was entered into in December 2003 and was extended for an additional 5 years in November 2012 (the “Mitek ORTHOVISC
Agreement”). Outside of the U.S., we have a number of distribution relationships servicing international markets including Canada,
Europe, the Middle East, Latin America, and Asia. We will continue to seek to establish distribution relationships in other key markets.
See the sections captioned “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Management
Overview” and “Risk Factors.”
In the United States, MONOVISC is also indicated for the treatment of pain caused by osteoarthritis of the knee in patients who
have failed to respond adequately to conservative, non-pharmacologic therapy and to simple analgesics, such as acetaminophen.
MONOVISC is a sterile, clear, viscous solution of partially cross-linked sodium hyaluronate in a phosphate buffered saline solution. A
treatment of MONOVISC is comprised of one injection of the product delivered directly into the affected joint. MONOVISC became
available for sale in the United States in April 2014, and it is also marketed by Mitek under the terms of a fifteen-year licensing,
distribution, supply, and marketing agreement, which was entered into on December 21, 2011 (the “Mitek MONOVISC Agreement”).
Outside of the United States, we have a number of distribution relationships servicing international markets including Canada, Europe,
Latin America, Asia, and certain other international countries. We continue to seek to establish distribution relationships in other key
markets. See the sections captioned “Management’s Discussion and Analysis of Financial Condition and Results of Operations—
Management Overview” and “Risk Factors.”
In addition to the four viscosupplementation products discussed above, we also offer several additional products used in
connection with orthopedic regenerative medicine. These products are based on the HYAFF technology and are currently available in
Europe, South America, and Asia. They include HYALOFAST, a biodegradable support for human bone marrow mesenchymal stem
cells used for cartilage regeneration and as an adjunct for microfracture surgery; HYALONECT, a woven gauze used as a graft wrap;
and HYALOSS MATRIX, HYAFF fibers used to mix blood/bone grafts to form a paste for bone regeneration. We also offer
HYALOGLIDE, an ACP gel used in tenolysis treatment, with the potential for use in flexor tendon adhesion prevention and for use in
the shoulder for prevention of adhesive capsulitis with additional clinical data. This product is commercialized through a network of
distributors, primarily in Europe, the Middle East, and Korea. In addition to these products, we received CE Mark approval in December
2016 for a product which utilizes our proprietary HA technology to treat pain associated with lateral epicondylitis, better known as
tennis elbow. Outside of the United States, this product will be marketed under the trade name ORTHOVISC-T. We submitted a CE
Mark application for this treatment during the first quarter of 2016 and received CE Mark approval in December 2016. We expect to
initially commercialize this treatment through our European, and certain other, distribution partners in the first half of 2017.
Additionally, in the second quarter of 2016, we submitted an Investigational Device Exemption (“IDE”) to the FDA to conduct a Phase
III clinical trial for this treatment, and the IDE was approved by the FDA in June 2016. In total, orthobiologics products accounted for
87%, 84%, and 82% of our product revenue in 2016, 2015, and 2014 respectively.
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Dermal
Our dermal products consist of advanced wound care products, based on the HYAFF technology, and an aesthetic dermal filler,
based on our proprietary chemically modified cross-linked HA technology. Products utilizing our HYAFF technology are used for the
treatment of skin wounds, ranging from burns to diabetic ulcers. The products cover a variety of wound treatment solutions including
debridement agents, advanced therapies to aid healing, and scaffolds used as skin substitutes. Leading products include
HYALOMATRIX and HYALOFILL, for the treatment of complex wounds such as burns and ulcers. The dermal products are
commercialized through a network of distributors, primarily in the United States, Europe, Latin America, and the Middle East. Several
of the products are also cleared for sale in the United States including HYALOMATRIX, HYALOFILL, HYALOGRAN, and
HYALOMATRIX 3D. We previously entered into a distribution agreement for the sale of advanced wound care products in nine South
American countries, including Argentina, Brazil, Mexico, and Chile, on an exclusive basis through 2018. We have also entered into an
agreement with Medline Industries, Inc. to commercialize HYALOMATRIX in the United States on an exclusive basis through 2019.
Our aesthetic dermatology product is a dermal filler based on our proprietary, chemically modified, cross-linked HA, and it is
commercialized in certain European Union countries, Canada, South Korea, and select countries in the Middle East. Internationally, this
product is marketed under the ELEVESS name. In the United States, the trade name is HYDRELLE, although the product is not
currently marketed in the United States.
Surgical
Our surgical business consists of products used to prevent post-surgical adhesions after abdominal-pelvic, spinal, and ear, nose,
and throat (“ENT”) surgeries. HYALOBARRIER is a clinically proven post-operative adhesion barrier for use in the abdominopelvic
area. The product is currently commercialized in Europe, the Middle East, and certain Asian countries through a distribution network,
but it is not approved for sale in the United States. HYALOSPINE, a product designed to prevent post-surgical adhesions following
spinal surgery, was CE Mark approved in January 2015. INCERT, approved for sale and commercialized through a network of
distributors in Europe, Turkey, and Malaysia, is a chemically modified, cross-linked HA product, for the prevention of spinal post-
surgical adhesions. There are currently no plans at this time to distribute INCERT in the United States.
Surgical adhesions occur when fibrous bands of tissues form between adjacent tissue layers during the wound healing process.
Although surgeons attempt to minimize the formation of adhesions, they nevertheless occur quite frequently after surgery. Adhesions in
the abdominal and pelvic cavity can cause particularly serious problems such as intestinal blockage following abdominal surgery and
infertility following pelvic surgery. Fibrosis following spinal surgery can complicate re-operation and may cause pain.
We offer several products used in connection with the treatment of ENT disorders. The lead products are MEROGEL, a woven
fleece nasal packing, and MEROGEL INJECTABLE, a thick, viscous hydrogel composed of cross-linked hyaluronic acid—a
biocompatible agent that creates a moist wound-healing environment. We have partnered with Medtronic XoMed, Inc. (“Medtronic”) for
worldwide distribution of these ENT products.
Other
Our other products include our ophthalmic and veterinary products, which are legacy products and not a part of our core business.
Our ophthalmic business includes injectable, high molecular weight HA products used as viscoelastic agents in ophthalmic surgical
procedures such as cataract extraction and intraocular lens implantation. These products coat, lubricate, and protect sensitive tissue such
as the endothelium, and they function to maintain the shape of the eye, thereby facilitating ophthalmic surgical procedures. Our veterinary
product, HYVISC, is a high molecular weight injectable HA product for the treatment of joint dysfunction in horses due to non-infectious
synovitis associated with equine osteoarthritis. HYVISC has viscoelastic properties that lubricate and protect the tissues in horse joints.
HYVISC is distributed by Boehringer Ingelheim Vetmedica, Inc. (“Boehringer”) in the United States and in selected countries in the
Middle East.
See Note 15 “Revenue by Product Group, by Significant Customer and by Geographic Location; Geographic Information” to our
consolidated financial statements included elsewhere in this Annual Report on Form 10-K for a discussion regarding our segments and
geographic sales.
See also the section captioned “Risk Factors—Risks Related to Our Business and Industry—We experience quarterly sales volume
variation, which makes our future results difficult to predict and makes period-to-period comparisons potentially not meaningful” for a
discussion regarding the effect that quarterly sales volume variation could have on our business and financial performance.
See also the section captioned “Risk Factors —Risks Related to Our Business and Industry—A significant portion of our revenues are
derived from a small number of customers, the loss of which could materially adversely affect our business, financial condition and results of
operations” for a discussion regarding our dependence on large-volume customers and the effects that the loss of any such customer could have
on our business and financial performance.
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See also the section captioned “Risk Factors—Risks Related to Our Business and Industry—Our manufacturing processes involve
inherent risks, and disruption could materially adversely affect our business, financial condition and results of operations” for a discussion of
the sources and availability of raw materials related to the manufacture of our products.
Research and Development of Potential Products
Our research and development efforts primarily consist of the development of new medical applications for our HA-based technology,
the management of clinical trials for certain product candidates, the preparation and processing of applications for regulatory approvals or
clearances at all relevant stages of product development, and process development and scale-up manufacturing activities for our existing and
new products. Our development focus includes products for tissue protection, repair, and regeneration. For the years ended December 31, 2016,
2015 and 2014, these expenses were $10.7 million, $9.0 million, and $8.1 million, respectively. We anticipate that we will continue to commit
significant resources to, and increase our aggregate spending on, research and development activities, including in relation to clinical trials, in
the future.
Our second single-injection osteoarthritis product under development in the United States is CINGAL, which is composed of our
proprietary cross-linked HA material combined with an approved steroid and is designed to provide both short- and long-term pain relief to
patients. We completed an initial CINGAL phase III clinical trial, including the associated statistical analysis for 368 enrolled patients, during
the fourth quarter of 2014 with data indicating that the product met all primary and secondary endpoints set forth for the trial. During the first
half of 2015, we completed a CINGAL retreatment study with 242 patients who had participated in the phase III clinical trial and reported
safety data related to the retreatment study. This initial phase III clinical trial and the associated retreatment study supported the Health Canada
and CE Mark approval of the product, and the commercial launch of the product in both Canada and the European Union occurred in the second
quarter of 2016. In the United States, after discussions with the FDA related to the regulatory pathway for CINGAL, we conducted a formal
meeting with the FDA’s Office of Combination Products (“OCP”) to present and discuss our data in September 2015, and we submitted a
formal request for designation with OCP a month later. In its response to our formal request for designation, OCP assigned the product to the
FDA’s Center for Drug Evaluation and Research (“CDER”) as the lead agency center for premarket review and regulation. Since then, we have
been in ongoing discussions with CDER to understand the requirements for submitting a New Drug Application (“NDA”) for CINGAL. We
held a meeting with CDER at the end of September 2016 to align on an approval framework and on submission requirements for this NDA for
CINGAL, including the execution of an additional Phase III clinical trial to supplement our strong, existing CINGAL pivotal study data. We
submitted an Investigational New Drug Application (“IND”) in late 2016, and discussions with CDER to this point indicate that they do not
have objections to our clinical protocol design. As a result, we plan to commence this second phase III clinical trial in the first quarter of 2017
with the first patient to be treated in the second quarter of 2017.
We have several research and development programs underway for new products, including for HYALOFAST (in the United States),
an innovative product for cartilage tissue repair, HYALOBONE, a bone void filler, and other early stage regenerative medicine development
programs. HYALOFAST received CE Mark approval in September 2009, and it is commercially available in Europe and certain international
countries. During the first quarter of 2015, we submitted an IDE for HYALOFAST to the FDA, which was approved in July 2015. We
commenced patient enrollment in a clinical trial in December 2015, and we are advancing site initiations and patient enrollment activities. In
the second quarter of 2016, a supplement to the HYALOFAST IDE was approved to expand the inclusion criteria for the clinical study. The
purpose of this supplement is to allow us to increase enrollment rates with the ultimate goal of decreasing the time needed to complete the
clinical trial. We are also currently proceeding with other research and development programs, one of which utilizes our proprietary HA
technology to treat pain associated with common repetitive overuse injuries, such as lateral epicondylitis, also known as tennis elbow. We
submitted a CE Mark application for this treatment during the first quarter of 2016 and received a CE Mark for the treatment of pain associated
with tennis elbow in December 2016. Outside of the United States, this product will be marketed under the trade name ORTHOVISC-T.
Additionally, in the second quarter of 2016, we submitted an IDE to the FDA to conduct a phase III clinical trial for this treatment, which was
approved by the FDA in June 2016 and which we plan to commence during the second half of 2017. We also have other research and
development programs underway focused on expanding the indications of our current products, including one program being conducted and
funded by our U.S. MONOVISC distribution partner, Mitek, seeking to expand MONOVISC’s indication to include treatment of pain
associated with osteoarthritis of the hip.
In June 2015, we entered into an agreement with the Institute for Applied Life Sciences at the University of Massachusetts
Amherst to collaborate on research to develop a therapy for rheumatoid arthritis. The purpose of this research is to develop a novel
modality for the treatment of rheumatoid arthritis and, if successful, it is expected to yield a potential product candidate that we could
begin to move towards commercialization as early as 2017.
Our research and development efforts may not be successful in (1) developing our existing product candidates, (2) expanding
the therapeutic applications of our existing products, or (3) resulting in new applications for our HA technology. There is also a risk that
we may choose not to pursue development of potential product candidates. We may not be able to obtain regulatory approval for any
new applications we develop. Furthermore, even if all regulatory approvals are obtained, there can be no assurances that we will achieve
meaningful sales of such products or applications.
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See also the section captioned “Risk Factors—Risks Related to Our Business and Industry—Failure to obtain, or any delay in
obtaining, FDA or other U.S. and foreign governmental approvals for our products may have a material adverse effect on our business,
financial condition and results of operations” for a discussion regarding the impact of government regulations on our product
development activities.
Patent and Proprietary Rights
Our products and trademarks, including our corporate name, product names, and logos, are proprietary. We rely on a
combination of patent protection, trade secrets and trademark laws, license agreements, and confidentiality and other contractual
provisions to protect our proprietary information.
We have a policy of seeking patent protection for patentable aspects of our proprietary technology. In the United States, we
own 21 patents, 1 of which is co-owned with other parties, license 14 patents, and have 5 patent applications currently pending. These
U.S. patents have expiration dates through 2030. Internationally, we own 151 patents, 7 of which are co-owned with other parties,
license 81 patents, and have 9 patent applications currently pending. Outside of the United States, we own, co-own, license, or have filed
for patents in 28 jurisdictions. Our international patents have expiration dates through 2032. In 2016, we were granted 1 new patent in
Canada. Many of these patents, including all licensed patents, belong to the Anika S.r.l. patent estate, which is extensive and partly
intertwined with its former parent company, Fidia Farmaceutici S.p.A. (“Fidia”), through a patent licensing agreement that provides
Anika S.r.l. with access to certain of Fidia’s patents to the extent required to support Anika S.r.l.’s products. In 2016, 9 of the patents
belonging to the Anika S.r.l. patent estate expired in the United States and 47 expired internationally. We intend to seek patent
protection for products and processes developed in the course of our activities when we believe such protection is in our best interests
and when the cost of seeking such protection is not inordinate relative to the potential benefits.
Other entities have filed patent applications for, or have been issued patents concerning, various aspects of HA-related products
or processes. In addition, the products or processes we develop may infringe the patent rights of others in the future. Any such
infringement may have a material adverse effect on our business, financial condition, and results of operations.
We rely upon trade secrets and proprietary know-how for certain non-patented aspects of our technology. To protect such
information, we require certain customers and vendors, and all employees, consultants, and licensees to enter into confidentiality
agreements limiting the disclosure and use of such information. These agreements, however, may not provide adequate protection.
See also the section captioned “Risk Factors—Risks Related to Our Intellectual Property— We may be unable to adequately
protect our intellectual property rights, which could have a material impact on our business and future financial results” for a
discussion of the risks we face with respect to protecting intellectual property developed by us.
We have granted Mitek an exclusive and non-transferable royalty bearing license to develop, commercialize, and sell
ORTHOVISC and MONOVISC in the United States pursuant to the Mitek ORTHOVISC Agreement and the Mitek MONOVISC
Agreement. These agreements include a license to manufacture, and have manufactured, such products in the event that we are unable to
supply Mitek with ORTHOVISC or MONOVISC in accordance with the terms of the relevant agreement. We have also granted Mitek
the exclusive, royalty free right to use the trademarks ORTHOVISC and MONOVISC in connection with the marketing, distribution,
and sale of the licensed products within the United States.
Government Regulation
The clinical development, manufacturing, and marketing of our products are subject to governmental regulation in the United
States, the European Union and other territories worldwide. Various statutes, regulations, directives, and guidelines, including the Food,
Drug, and Cosmetic Act in the United States, govern the development, design, non-clinical and clinical research, testing, manufacture,
safety, efficacy, labeling, packaging, storage, record keeping, premarket clearance or approval, adverse event reporting, advertising, and
promotion of our products. Product development and approval within these various regulatory frameworks takes a number of years and
involves the expenditure of substantial resources. Pharmaceutical and medical device manufacturers are also inspected regularly by the
FDA and other applicable regulatory bodies.
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Medical products regulated by the FDA are generally classified as drugs, biologics, or medical devices. Medical devices
intended for human use are classified into three categories (Class I, II or III) on the basis of the controls deemed reasonably necessary by
the FDA to assure their safety and effectiveness. Class II devices are cleared for marketing under the premarket notification 510(k)
regulatory pathway, which may include clinical testing. Class III devices require pre-market approval based on valid scientific evidence
of safety and effectiveness, including evidence elicited through appropriate clinical testing. Drugs and biologic products undergo
rigorous preclinical testing prior to beginning clinical trials. Clinical trials for new drugs or biologic products include Phase I trials in
healthy volunteers to understand safety, dosage tolerance, and pharmacokinetics, Phase II trials in a limited patient population to identify
initial efficacy and side effects, and Phase III pivotal trials to statistically evaluate the safety and efficacy of the product. The failure to
adequately demonstrate the quality, safety, and efficacy of a product under development can delay or prevent regulatory approval of the
product. In order to gain marketing approval, we must submit to the relevant regulatory authority for review information on the quality
aspects of the product as well as the non-clinical and clinical data. The FDA undertakes this review in the United States.
In the European Union, medical devices must be CE Marked in order to be marketed. CE marking a device involves working
with a Notified Body, and in some cases a Competent Authority, to demonstrate that the device meets all applicable requirements of the
Medical Devices Directive and that our Quality Management System is compliant. Drug approval in the European Union follows one of
several possible processes: (i) a centralized procedure involving members of the European Medicines Agency’s Committee for
Medicinal Products for Human Use; (ii) a “mutual recognition procedure” in which an individual country's regulatory agency approves
the product followed by “mutual recognition” of this approval by regulatory agencies of other countries; or (iii) a decentralized
procedure in which the approval is sought through the regulatory agencies of multiple countries at the same time.
Approval timelines can range from several months to several years, or applications can be denied entirely. The approval process
can be affected by a number of factors. For example, additional studies or clinical trials may be requested during the review, which may
delay marketing approval and involve unbudgeted costs. As a condition of approval, the regulatory agency may require post-marketing
surveillance to monitor for adverse effects, and may require other additional studies, as it deems appropriate. After approval for an initial
indication, further clinical studies are generally necessary to gain approval for any additional indications. The terms of any approval,
including labeling content, may be more restrictive than expected and could affect the marketability of a product.
As a condition of approval, the relevant regulatory agency requires that the product continues to meet applicable regulatory
requirements related to quality, safety, and efficacy, and it requires strict procedures to monitor and report any adverse effects. Where
adverse effects occur or may occur, the regulatory agency may require additional studies or changes to the labeling. Compelling new
“adverse” data may result in a product approval being withdrawn at any stage following review by an agency and discussion with the
product manufacturer.
The branch of the FDA responsible for product marketing oversight routinely reviews company marketing practices and also
may impose pre-clearance requirements on materials intended for use in marketing of approved drug products. We are also subject to
various U.S. federal and state laws pertaining to healthcare fraud and abuse, including anti-kickback and false claims laws. Similar
review and regulation of advertising and marketing practices exists in the other geographic areas where we operate.
The FDA has broad regulatory compliance and enforcement powers. If the FDA determines that we failed to comply with
applicable regulatory requirements, it can take a variety of compliance or enforcement actions, including, without limitation, issuing an
FDA Form 483 notice of inspectional observations or a warning letter, imposing civil money penalties, suspending or delaying issuance
of approvals, requiring product recall, imposing a total or partial shutdown of production, withdrawal of approvals or clearances already
granted, pursuing product seizures, consent decrees or other injunctive relief, or criminal prosecution through the Department of Justice.
The FDA can also require us to repair, replace or refund the cost of products that we manufactured or distributed. Outside the US,
regulatory agencies may exert a range of similar powers.
See also the sections captioned “Risk Factors—Risks Related to Our Business and Industry—Failure to obtain, or any delay in
obtaining, FDA or other U.S. and foreign governmental approvals for our products may have a material adverse effect on our business,
financial condition and results of operations,” “Risk Factors—Risks Related to Our Business and Industry—Once obtained, we cannot
guarantee that FDA or international product approvals will not be withdrawn or that relevant agencies will not require other corrective
action, and any withdrawal or corrective action could materially affect our business and financial results,” “Risk Factors—Risks
Related to Our Business and Industry—Our operations and products are subject to extensive regulation, compliance with which is costly
and time consuming, and our failure to comply may result in substantial penalties, including recalls of our products,” and “Risk
Factors—Risks Related to Our Business and Industry—Any changes in FDA or international regulations related to product approval,
including those that apply retroactively, could adversely affect our competitive position and materially affect our business and financial
results” for a discussion regarding the potential impact of government regulations on our business and financial results.
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Competition
We compete with many companies including, among others, large pharmaceutical firms and specialized medical products
companies, across all of our product lines. Many of these companies have substantially greater financial resources, larger research and
development staffs, more extensive marketing and manufacturing organizations, and more experience in the regulatory processes than
we have. We also compete with academic institutions, government agencies, and other research organizations, which may be involved in
the research and development and commercialization of products. Many of our competitors also compete against us in securing
relationships with collaborators for their research and development and commercialization programs.
We compete with other market participants primarily on the efficacy of our products, our products’ reputation for safety, our
focus on HA-based products, and the breadth of our HA-based product portfolio. Other factors that impact competition in our industry
are the timing and scope of regulatory approvals, the availability of raw material and finished product supply, marketing and sales
capability, reimbursement coverage, product pricing, and patent protection. Some of the principal factors that may affect our ability to
compete in the HA development and commercialization markets include:
The quality and breadth of our continued development of our technology portfolio;
Our ability to complete successful clinical studies and obtain FDA marketing and foreign regulatory approvals prior to our
competitors;
The successful execution of our commercial strategies;
Our ability to recruit and retain skilled employees; and
The availability of capital resources to fund strategic activities related to the significant expansion of our business or
product portfolio.
We are aware of several companies that are developing and/or marketing products utilizing HA for a variety of human
applications. In some cases, competitors have already obtained product approvals, submitted applications for approval, or commenced
human clinical studies, either in the United States or in certain foreign countries. All of our products face substantial competition. There
exist major worldwide competing products, made from HA and other materials, for use in orthopedics, surgical adhesion prevention,
advanced wound care, ENT, cosmetic dermatology, and ophthalmic surgery. There is a risk that we will be unable to compete
effectively against our current or future competitors. Additionally, legislation and regulation aimed at curbing rising healthcare costs has
resulted in a consolidation trend in the healthcare industry to create larger companies, including hospitals, with greater market power. In
turn, this has led to greater and more intense competition in the provision of products and services to market participants. Important
market makers, like group purchasing organizations, have increased their negotiating leverage, and if these market makers demand
significant price concessions or if we are excluded as a supplier by these market makers, our product revenue could be adversely
impacted.
See also the sections captioned “Risk Factors—Risks Related to Our Business and Industry—Substantial competition could
materially affect our financial performance” and “Risk Factors—Risks Related to Our Business and Industry—Our business may be
adversely affected if consolidation in the healthcare industry leads to demand for price concessions or if we are excluded from being a
supplier by a group purchasing organization or similar entity” for additional discussion of the impact competition could have on our
business and financial results.
Employees
As of December 31, 2016, we had 122 employees, 21 of whom were located outside the United States. We consider our
relations with our employees to be good. None of our U.S. employees are represented by labor unions, but most of the employees based
in Italy are represented by unions, adding complexity and additional risks to the wage and employment decision processes.
Environmental Laws
We believe that we are in compliance with all foreign, federal, state, and local environmental regulations with respect to our
manufacturing facilities and that the cost of ongoing compliance with such regulations does not have a material effect on our operations.
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Product Liability
The testing, marketing, and sale of human health care products entails an inherent risk of allegations of product liability, and we
cannot assure that substantial product liability claims will not be asserted against us. Although we have not received any material
product liability claims to date and have coverage under our insurance policy of $5.0 million per occurrence and $5.0 million in the
aggregate, we cannot assure that if material claims arise in the future, our insurance will be adequate to cover all situations. Moreover,
we cannot assure that such insurance, or additional insurance, if required, will be available in the future or, if available, will be available
on commercially reasonable terms. Any product liability claim, if successful, could have a material adverse effect on our business,
financial condition, and results of operation.
Available Information
Our Annual Reports on Form 10-K, including our consolidated financial statements, Quarterly Reports on Form 10-Q, Current
Reports on Form 8-K and other information, including amendments and exhibits to such reports, filed or furnished pursuant to the
Securities Exchange Act of 1934, as amended, are available free of charge in the “SEC Filings” section of our website located at
http://www.anikatherapeutics.com, as soon as reasonably practicable after the reports are filed with or furnished to the SEC. The
information on our website is not part of this Annual Report on Form 10-K. Reports filed with the SEC may be viewed at www.sec.gov
or obtained at the SEC Public Reference Room at 100 F Street NE, Washington, D.C. 20549. Information regarding the operation of the
Public Reference Room may be obtained by calling the SEC at 1-800-SEC-0330.
ITEM 1A. RISK FACTORS
Our operating results and financial condition have varied in the past and could vary significantly in the future depending on a
number of factors. You should consider carefully the risks and uncertainties described below, in addition to the other information
contained in this Annual Report on Form 10-K, before deciding whether to purchase our common stock. If any of the following risks
actually occurs, our business, financial condition, results of operations, and future prospects could be materially and adversely affected.
In that event, the trading price of our common stock could decline, and you could lose part or all of your investment.
Risks Related to Our Business and Industry
Failure to obtain, or any delay in obtaining, FDA or other U.S. and foreign governmental approvals for our products may have a
material adverse effect on our business, financial condition and results of operations.
Several of our current products, and any future products we may develop, will require clinical trials to determine their safety
and efficacy for United States and international marketing approval by regulatory bodies, including the FDA. Product development and
approval within the FDA framework takes a number of years and involves the expenditure of substantial resources. There can be no
assurance that the FDA will accept submissions related to our new products or the expansion of the indications of our current products,
and, even if submissions are accepted, there can be no guarantee that the FDA will grant approval for our new products, including
CINGAL, HYALOFAST, or other line extensions of our current products, or for the expansion of indications of our current products on
a timely basis, if at all. In addition to regulations enforced by the FDA, we are subject to other existing and future federal, state, local,
and foreign regulations applicable to product approval, which may vary significantly across jurisdictions. Additional approval of
existing products may be required when changes to such products may affect the safety and effectiveness, including for new indications
for use, labeling changes, process or manufacturing changes, the use of a different facility to manufacture, process or package the
device, and changes in performance or design specifications. Failure to obtain regulatory approvals of our products, including any
changes to existing products, could have an adverse material impact on our business, financial condition, and results of operations.
Even if ultimately granted, FDA and international regulatory approvals may be subject to significant, unanticipated delays
throughout the regulatory approval process. Internally, we make assumptions regarding product approval timelines, both in the United
States and internationally, in our business planning, and any delay in approval could materially affect our competitive position in the
relevant product market and our projections related to future business results.
We cannot be certain that product approvals, both in the United States and internationally, will not include significant
limitations on the product indications, and other claims sought for use, under which the products may be marketed. The relevant
approval or clearance may also include other significant conditions of approval such as post-market testing, tracking, or surveillance
requirements. Any of these factors could significantly impact our competitive position in relation to such products and could have a
negative impact on the sales of such products.
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Once obtained, we cannot guarantee that FDA or international product approvals will not be withdrawn or that relevant agencies will
not require other corrective action, and any withdrawal or corrective action could materially affect our business and financial results.
Once obtained, marketing approval can be withdrawn by the FDA or comparable foreign regulatory agencies for a number of
reasons, including the failure to comply with ongoing regulatory requirements or the occurrence of unforeseen problems following
initial approval. Regulatory authorities could also limit or prevent the manufacture or distribution of our products. Any regulatory
limitations on the use of our products or any withdrawal or suspension of approval or rescission of approval by the FDA or a comparable
foreign regulatory agency could have a material adverse effect on our business, financial condition, and results of operations.
Our operations and products are subject to extensive regulation, compliance with which is costly and time consuming, and our
failure to comply may result in substantial penalties, including recalls of our products.
The FDA and foreign regulatory bodies impose extensive regulations applicable to our operations and products, including
regulations governing product standards, packing requirements, labeling requirements, quality system and manufacturing requirements,
import restrictions, tariff regulations, duties, and tax requirements. We cannot assure you that we will be able to achieve and maintain
compliance required for FDA, CE marking, or other foreign regulatory approvals for any or all of our operations and products or that we
will be able to produce our products in a timely and profitable manner while complying with applicable requirements.
Failure to comply with applicable regulatory requirements could result in substantial penalties, including warning letters, fines,
injunctions, civil penalties, seizure of products, total or partial suspension of production, refusal to grant pre-market clearance or pre-
market approval for devices or drugs, withdrawal of approvals, and criminal prosecution. Additionally, regulatory authorities have the
power to require the recall of our products. It also might be necessary for us, in applicable circumstances, to initiate a voluntary recall
per regulatory requirements of one or several of our products. The imposition of any of the foregoing penalties, whether voluntarily or
involuntary, could have a material negative impact on our business, financial condition, and results of operations.
Any changes in FDA or international regulations related to product approval, including those that apply retroactively, could adversely
affect our competitive position and materially affect our business and financial results.
FDA and foreign regulations depend heavily on administrative interpretation, and we cannot assure you that future
interpretations made by the FDA or other regulatory bodies, with possible retroactive effect, will not adversely affect us. Additionally,
any changes, whether in interpretation or substance, in existing regulations or policies, or any future adoption of new regulations or
policies by relevant regulatory bodies, could prevent or delay approval of our products. In the event our future, or current, products,
including HA generally, are classified, or re-classified, as human drugs, combination products, or biologics by the FDA or an applicable
international regulatory body, the applicable review process related to such products is typically substantially longer and substantially
more expensive than the review process to which they are currently subject as medical devices, which could materially impact our
competitive position, business, and financial results.
We are implementing a direct sales model to commercialize our CINGAL product, as well as certain other future products, in the
United States and we may face unforeseen difficulties and delays in implementing this new model, which could affect our business
and financial results.
For the first time, we are implementing a direct sales model to market and promote one of our products, CINGAL, in the United
States, initially through a contract sales organization, with the ultimate goal of transitioning the direct sales function into our company as
part of a broader buildout of our commercial capabilities. We may also use this direct model to commercialize other of our products in
the United States in the future. Our success in utilizing this sales model will initially depend in part on our ability to successfully
develop and implement the necessary internal and external resources to manage the contract sales organization and the sales of the
product. Our longer term success will depend on our ability to transition the direct sales function into our company and to manage all
resources associated with this function. We cannot assure you that there will not be unforeseen roadblocks or delays in finalizing the
contracts related to, and implementing, the relationship with the contract sales organization, nor we can we assure you that we will not
face setbacks in transitioning the direct sales function into our organization. The initial implementation timeline of this direct sales
model is also dependent on CINGAL obtaining FDA approval in a timely manner, of which there is no guarantee. Failure to timely
implement our direct sales model or to successfully manage the implementation or transition process could materially impact our
competitive position, business, and financial results.
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Substantial competition could materially affect our financial performance.
We compete with many companies, including large pharmaceutical companies, specialized medical products companies, and
healthcare companies. Many of these companies have substantially greater financial resources, larger research and development staffs,
more extensive marketing and manufacturing organizations, and more experience in the regulatory process than us. We also compete
with academic institutions, government agencies, and other research organizations that may be involved in research, development, and
commercialization of products similar to our own. Because a number of companies are developing or have developed HA products for
similar applications and have received FDA approval, the successful commercialization of a particular product will depend in part upon
our ability to complete clinical studies and obtain FDA marketing and foreign regulatory approvals prior to our competitors, or, if
regulatory approval is not obtained prior to our competitors, to identify markets for our products that may be sufficient to permit
meaningful sales of our products. For example, we are aware of several companies that are developing and/or marketing products
utilizing HA for a variety of human applications. In some cases, competitors have already obtained product approvals, submitted
applications for approval, or have commenced human clinical studies, either in the United States or in certain foreign countries. There
exist major competing products for the use of HA in ophthalmic surgery. In addition, certain HA products made by our competitors for
the treatment of osteoarthritis in the knee received FDA approval before ours and have been marketed in the United States since 1997, as
well as select markets in Canada, Europe, and other countries. There can be no assurance that we will be able to compete against current
or future competitors or that competition will not have a material adverse effect on our business, financial condition, and results of
operations.
We may rely on third parties to support certain aspects of our clinical trials. If these third parties do not successfully carry out their
contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval or commercialize our products and
our business could be substantially harmed.
We have hired experienced clinical development and regulatory staff, and we have also retained the services of knowledgeable
external service providers, including consultants and clinical research organizations, to develop and supervise our clinical trials and
regulatory processes. Despite our internal investment in staffing, we will remain dependent upon these third party contract research
organizations to carry out portions of our clinical and preclinical research studies for the foreseeable future. As a result, we have had and
will have less control over the conduct of the clinical trials, the timing and completion of the trials, the required reporting of adverse
events, and the management of data developed through the trials than would be the case if we were relying entirely on our own staff.
Outside parties may have staffing difficulties, may undergo changes in priorities or may become financially distressed, adversely
affecting their willingness or ability to conduct our trials. Failure by these third parties to comply with regulatory requirements or to
meet timing expectations may require us to repeat clinical or preclinical trials, which would delay the regulatory approval process, or
require substantial unexpected expenditures.
We are dependent upon marketing and distribution partners and the failure to maintain strategic alliances on acceptable terms will
have a material adverse effect on our business, financial condition and results of operations.
Our success will be dependent, in part, upon the efforts of our marketing and distribution partners and the terms and conditions
of our relationships with such partners. One partner, Mitek accounted for 75% of our product revenue in fiscal year 2016. We cannot
assure you that our partners, including Mitek, will not seek to renegotiate their current agreements on terms less favorable to us or
terminate such agreements. A failure to renew these partnerships on terms satisfactory to us, or at all, could result in a material adverse
effect on our operating results.
We continue to seek to establish long-term distribution relationships in regions and countries not covered by existing
agreements, and we may need to obtain the assistance of additional marketing partners to bring new and existing products to market and
to replace certain marketing partners. There can be no assurance that we will be able to identify or engage appropriate distribution or
collaboration partners or effectively transition to any such partners. The failure to establish strategic partnerships for the marketing and
distribution of our products on acceptable terms and within our planned timeframes could have a material adverse effect on our business,
financial condition, and results of operations.
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We must achieve market acceptance of our products in order to be successful in the future.
Our success will depend in part upon the acceptance of our existing and future products by the medical community, hospitals
and physicians and other health care providers, third-party payers, and end-users. Such acceptance may depend upon the extent to which
the medical community and end-users perceive our products as safer, more effective, or more cost-competitive than other similar
products. Ultimately, for our new products to gain general market acceptance, it may also be necessary for us to develop marketing
partners or viable commercial strategies for the distribution of our products. There can be no assurance that our new products will
achieve significant market acceptance on a timely basis, or at all. Failure of some or all of our future products to achieve significant
market acceptance could have a material adverse effect on our business, financial condition, and results of operations.
Our manufacturing processes involve inherent risks, and disruption could materially adversely affect our business, financial condition,
and results of operations.
The operation of biomedical manufacturing plants involves many risks, including the risks of breakdown, failure, or
substandard performance of equipment, the occurrence of natural and other disasters, and the need to comply with the requirements of
directives of government agencies, including the FDA. In addition, we rely on a single supplier for certain key raw materials and a small
number of suppliers for a number of other materials required for the manufacturing and delivery of our HA products. Although we
believe that alternative sources for many of these and other components and raw materials that we use in our manufacturing processes
are available, we cannot be certain that the supply of key raw materials, specifically HA, will continue be available at current levels or
will be sufficient to meet our future needs. Any supply interruption could harm our ability to manufacture our products until a new
source of supply is identified and qualified. We may not be able to find sufficient alternative suppliers in a reasonable time period, or on
commercially reasonable terms, if at all, and our ability to produce and supply our products could be impaired.
We use raw materials derived from animal sources to produce certain of our products, and there is no guarantee that we will be able
to continue to utilize this source of material in the future.
Our manufacturing processes and research and development efforts for some of our ophthalmic and veterinary products involve
products derived from animals. We procure our animal-derived raw materials from a qualified vendor, who controls for contamination
and has processes that effectively inactivate infectious agents; however, we cannot assure you that we can completely eliminate the risk
of transmission of infectious agents. Furthermore, regulatory authorities could in the future impose restrictions on the use of animal-
derived raw materials that could impact our business.
The utilization of animals in research and development and product commercialization is subject to increasing focus by animal
rights activists. The activities of animal rights groups and other organizations that have protested animal based research and
development programs or boycotted the products resulting from such programs could cause an interruption in our manufacturing
processes and research and development efforts. The occurrence of material operational problems, including but not limited to the events
described above, could have a material adverse effect on our business, financial condition, and results of operations during the period of
such operational difficulties and beyond.
We are in the process of transferring the manufacturing of our HYAFF products from Italy to our Bedford, MA facility, which
carries inherent risks of supply interruption.
We are currently in the process of transferring the manufacturing responsibilities for our HYAFF products from our previous
contract manufacturer in Italy to our facility in Bedford, MA. This process requires us to take several steps including, but not limited to,
building excess inventory of the products, installing the necessary equipment, including certain pieces of our equipment removed from
our contract manufacturer’s facility, in our Bedford, MA facility, and validating the equipment and achieving regulatory approval of the
manufacturing processes in accordance with all applicable law and regulations. There is no guarantee that any of these activities will not
become delayed or otherwise disrupted, which could lead to a supply interruption for the HYAFF products. Such an interruption could
ultimately have a material adverse effect on our business, financial condition, and results of operations.
Our Italian subsidiary, Anika Therapeutics S.r.l. (“Anika S.r.l.”) is moving from its current facility in Abano Terme, Italy to a new
facility in Padova, Italy, and there is no guarantee that this facility move will not result in an interruption of our business.
Anika S.r.l. currently occupies warehousing, and administrative space in Abano Terme, Italy. In October 2015, Anika S.r.l.
entered into a build-to-suit lease agreement to lease a new warehousing, research and development, and administrative facility in
Padova, Italy. We expect that we will move into this new facility in the first quarter of 2017. There is no guarantee that this move will be
completed smoothly and in a timely manner due to, among other things, unexpected construction delays or unexpected difficulties
related to the lessor achieving necessary permitting, and any delay has the potential to cause a disruption to our business activities. If
there is a business disruption or the move is delayed, this could ultimately have a material adverse effect on our business, financial
condition, and results of operations.
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Our financial performance depends on the continued sales growth and increasing demand for our products and we may not be able to
successfully manage the expansion of our operations.
Our future success depends on substantial growth in product sales. There can be no assurance that such growth can be achieved
or, if achieved, sustained. There can be no assurance that, even if substantial growth in product sales and the demand for our products is
achieved, we will be able to:
Develop and maintain the necessary manufacturing capabilities;
Obtain the assistance of additional marketing partners or develop appropriate alternative sales strategies;
Attract, retain, and integrate required key personnel; and
Implement the financial, accounting, and management systems needed to manage growing demand for our products.
Our failure to successfully manage future growth could have a material adverse effect on our business, financial condition, and
results of operations.
We may face circumstances in the future that will result in impairment charges, including, but not limited to, goodwill impairment
and In-Process Research and Development (“IPR&D”) charges.
As of December 31, 2016, we had long-lived assets, including goodwill, of $69.8 million. If the fair value of any of our long-
lived assets decreases as a result of an economic slowdown, a downturn in the markets where we sell products and services, or a
downturn in our financial performance or future outlook, we may be required to record an impairment charge on such assets.
We are required to test intangible assets with indefinite life periods for potential impairment annually and on an interim basis if
there are indicators of a potential impairment. We also are required to evaluate amortizable intangible assets and fixed assets for
impairment if there are indicators of a possible impairment. Impairment charges could have a negative impact on our results of
operations and financial position, as well as on the market price of our common stock.
Customer, vendor, and employee uncertainty about the effects of any acquisitions could harm us.
We and the customers of any companies we acquire may, in response to the consummation of any acquisitions, delay or defer
purchasing decisions. Any delay or deferral in purchasing decisions by customers could adversely affect our business. Similarly,
employees of acquired companies may experience uncertainty about their future role until or after we execute our strategies with regard
to employees of acquired companies. This may adversely affect our ability to attract and retain key management, sales, marketing, and
technical personnel following an acquisition.
We engage in acquisitions as a part of our growth strategy, which exposes us to a variety of risks that could adversely affect our
business operations.
Our business strategy includes the acquisition of businesses, technologies, services, or products that we believe are a strategic
fit with our business. We may fund these acquisitions by utilizing our cash, incurring debt, issuing additional shares of our common
stock, or by other means. Completed acquisitions may expose us to a number of risks and expenses, including unanticipated liabilities,
amortization expenses related to intangible assets with definite lives, or risks associated with entering new markets with which we have
limited experience or where commercial alliances with experienced partners or existing sales channels are not available. Whether or not
completed, acquisitions may result in diversion of management resources otherwise available for ongoing development of our business
and significant expenditures.
We may not be able to realize the expected benefits of any completed acquisitions, including growth synergies and cost savings
from the integration of acquired businesses or assets with our existing operations and technologies, as rapidly as expected, or at all. In
addition, the integration and reorganization processes for our acquisitions may be complex, costly, and time consuming and include
unanticipated issues, expenses, and liabilities. We may have difficulty in developing, manufacturing, and marketing the products of a
newly acquired company in a manner that enhances the performance of our combined businesses or product lines and allows us to
realize value from expected synergies. Moreover, we may lose key clients or employees of acquired businesses as a result of the change
in ownership to us. Following an acquisition, we may not achieve the revenue or net income levels that justify the acquisition.
Acquisitions may also result in one-time charges, such as write-offs or restructuring charges, impairment of goodwill or acquired In-
Process Research and Development, which could adversely affect our operating results. The failure to achieve the expected benefits of
any acquisition may harm our business, financial condition, and results of operations.
- 15 -
The acquisitions we have made or may make in the future may make us the subject of lawsuits from either an acquired company’s
stockholders, an acquired company’s previous stockholders, or our current stockholders.
We may be the subject of lawsuits from either an acquired company’s stockholders, an acquired company’s previous
stockholders, or our current stockholders. These lawsuits could result from the actions of the acquisition target prior to the date of the
acquisition, from the acquisition transaction itself, or from actions after the acquisition. Defending potential lawsuits could cost us
significant expense and distract management’s attention from the operation of the business. Additionally, these lawsuits could result in
the cancellation of, or the inability to renew, certain insurance coverage that would be necessary to protect our assets.
Attractive acquisition opportunities may not be available to us in the future.
We will consider the acquisition of other businesses. However, we may not locate suitable acquisition targets or have the
opportunity to make acquisitions of such targets on favorable terms in the future, which could negatively impact the growth of our
business. In order to pursue such opportunities, we may require significant additional financing, which may not be available to us on
favorable terms, if at all. The availability of such financing is limited by the continued tightening of the global credit markets. We expect
that our competitors, many of which have significantly greater resources than we do, will compete with us to acquire compatible
businesses. This competition could increase prices for acquisitions that we would likely pursue.
Sales of our products are largely dependent upon third party reimbursement and our performance may be harmed by health care
cost containment initiatives.
In the United States and other foreign markets, health care providers, such as hospitals and physicians, that purchase health care
products, such as our products, generally rely on third party payers, including Medicare, Medicaid, and other health insurance and
managed care plans, to reimburse all or part of the cost of the health care product. We generally depend upon the distributors of our
products to secure reimbursement and reimbursement approvals. Reimbursement by third party payers, both in the United States and
internationally, may depend on a number of factors, including the payer’s determination that the use of our products is clinically useful
and cost-effective, medically necessary, and not experimental or investigational. Since reimbursement approval is required from each
payer individually, seeking such approvals can be a time consuming and costly process which, in the future, could require us or our
marketing partners to provide supporting scientific, clinical, and cost-effectiveness data for the use of our products to each payer
separately. Significant uncertainty exists as to the reimbursement status of newly approved health care products, and any failure or delay
in obtaining reimbursement approvals can negatively impact sales of our new products.
In addition, third party payers are increasingly attempting to contain the costs of health care products and services by limiting
both coverage and the level of reimbursement for new therapeutic products and by refusing, in some cases, to provide coverage for uses
of approved products for disease indications for which the FDA, or the applicable foreign regulatory agency, has granted marketing
approval. Also, the U.S. Congress, certain state legislatures, and certain foreign governments and regulatory agencies have considered
reforms, including, among other items, the potential repeal of the Affordable Care Act in the United States, which may affect current
reimbursement practices and create additional uncertainty about the pricing of our products, including the potential implementation of
controls on health care spending through limitations on the growth of Medicare and Medicaid spending. There can be no assurance that
third party reimbursement coverage will be available or adequate for any products or services developed by us. Outside the United
States, the success of our products is also dependent in part upon the availability of reimbursement and health care payment systems.
Domestic and international reimbursement laws and regulations may change from time to time. Lack of adequate coverage and
reimbursement provided by governments and other third party payers for our products and services, including continuing coverage for
MONOVISC and ORTHOVISC in the United States, and any change of classification by the Centers for Medicare and Medicaid
Services for ORTHOVISC and MONOVISC, could have a material adverse effect on our business, financial condition, and results of
operations.
- 16 -
We may seek financing in the future, which could be difficult to obtain and which could dilute your ownership interest or the value
of your shares.
We had cash, cash equivalents, and investments of $124.8 million at December 31, 2016. Our future capital requirements and
the adequacy of available funds will depend, however, on numerous factors, including:
Market acceptance of our existing and future products;
The success and sales of our products under various distributor agreements and other appropriate commercial strategies,
including the ability of our partners to achieve third party reimbursement for our products;
The successful commercialization of products in development;
Progress in our product development efforts;
The magnitude and scope of such product development efforts;
Any potential acquisitions of products, technologies, or businesses;
Progress with preclinical studies, clinical trials, and product approvals and clearances by the FDA and other agencies;
The cost and timing of our efforts to manage our manufacturing capabilities and related costs;
The cost of filing, prosecuting, defending, and enforcing patent claims and other intellectual property rights and the cost of
defending any other legal proceeding;
Competing technological and market developments;
The development of strategic alliances for the marketing of certain of our products;
The terms of such strategic alliances, including provisions (and our ability to satisfy such provisions) that provide upfront
and/or milestone payments to us; and
The cost of maintaining adequate inventory levels to meet current and future product demand.
To the extent funds generated from our operations, together with our existing capital resources, are insufficient to meet future
requirements, we will be required to obtain additional funds through equity or debt financings, through strategic alliances with corporate
partners and others, or through other sources. The terms of any future equity financings may be dilutive to our investors and the terms of
any debt financings may contain restrictive covenants, which limit our ability to pursue certain courses of action. Our ability to obtain
financing is dependent on the status of our future business prospects as well as conditions prevailing in the relevant capital markets at
the time we seek financing. No assurance can be given that any additional financing will be made available to us or will be available on
acceptable terms should such a need arise.
We could become subject to product liability claims, which, if successful, could materially adversely affect our business, financial
condition, and results of operations.
The testing, marketing, and sale of human health care products entail an inherent risk of allegations of product liability, and
there can be no assurance that substantial product liability claims will not be asserted against us. Although we have not received any
material product liability claims to date and have an insurance policy of $5.0 million per occurrence and $5.0 million in the aggregate to
cover such product liability claims should they arise, there can be no assurance that material claims will not arise in the future or that our
insurance will be adequate to cover all situations. Moreover, there can be no assurance that such insurance, or additional insurance, if
required, will be available in the future or, if available, will be available on commercially reasonable terms. Any product liability claim,
if successful, could have a material adverse effect on our business, financial condition, and results of operations.
- 17 -
Our business is dependent upon hiring and retaining qualified management and technical personnel.
We are highly dependent on the members of our management and technical staff, the loss of one or more of whom could have a
material adverse effect on us. We have experienced a number of management changes in recent years, and there can be no assurances
that such management changes will not adversely affect our business. We believe that our future success will depend in large part upon
our ability to attract and retain technical and highly skilled managerial, professional, and technical personnel. We face significant
competition for such personnel from competitive companies, research and academic institutions, government entities, and other
organizations. There can be no assurance that we will be successful in hiring or retaining the personnel we require. The failure to hire
and retain such personnel could have a material adverse effect on our business, financial condition, and results of operations.
We are subject to environmental regulations and any failure to comply with applicable laws could subject us to significant liabilities
and harm our business.
We are subject to a variety of local, state, federal, and foreign government regulations relating to the storage, discharge,
handling, emission, generation, manufacture, and disposal of toxic or other hazardous substances used in the manufacture of our
products. Any failure by us to control the use, disposal, removal, or storage of hazardous chemicals or toxic substances could subject us
to significant liabilities, which could have a material adverse effect on our business, financial condition, and results of operations.
As our international sales and operations grow, we could become increasingly subject to additional economic, political, and other
risks that could harm our business.
Since we manufacture and sell our products worldwide, our business is subject to risks associated with doing business
internationally. During the years ended December 31, 2016, 2015, and 2014, 19%, 18%, and 13%, respectively, of our product sales
were to international distributors. We continue to be subject to a variety of risks, which could cause fluctuations in the results of our
international and domestic operations. These risks include:
The impact of recessions and other economic conditions in economies, including Europe in particular, outside the United
States;
Instability of foreign economic, political, and labor conditions;
Unfavorable labor regulations applicable to our European operations, such as severance and the unenforceability of non-
competition agreements in the European Union;
The impact of strikes, work stoppages, work slowdowns, grievances, complaints, claims of unfair labor practices, or other
collective bargaining disputes;
Difficulties in complying with restrictions imposed by regulatory or market requirements, tariffs, or other trade barriers or
by U.S. export laws;
Imposition of government controls limiting the volume of international sales;
Longer accounts receivable payment cycles;
Potentially adverse tax consequences, including, if required or applicable, difficulties transferring funds generated in non-
U.S. jurisdictions to the United States in a tax efficient manner;
Difficulties in protecting intellectual property, especially in international jurisdictions;
Difficulties in managing international operations; and
Burdens of complying with a wide variety of foreign laws.
Our success depends, in part, on our ability to anticipate and address these risks. We cannot guarantee that these or other factors
will not adversely affect our business or operating results.
- 18 -
Currency exchange rate fluctuations may have a negative impact on our reported earnings.
Approximately 9% of our business during fiscal year 2016 was conducted in functional currencies other than the U.S. dollar,
which is our reporting currency. Thus, currency fluctuations among the U.S. dollar and the other currencies in which we do business
have caused and will continue to cause foreign currency transaction gains and losses. Currently, we attempt to manage foreign currency
risk through the matching of assets and liabilities. In the future, we may undertake to manage foreign currency risk through additional
hedging methods. We recognize foreign currency gains or losses arising from our operations in the period incurred. We cannot guarantee
that we will be successful in managing foreign currency risk or in predicting the effects of exchange rate fluctuations upon our future
operating results because of the variability of currency exposure and the potential volatility of currency exchange rates.
A significant portion of our revenues are derived from a small number of customers, the loss of which could materially adversely affect
our business, financial condition and results of operations.
We have historically derived the majority of our revenues from a small number of customers who resell our products to end-
users, and most of these customers are significantly larger companies than us. For the year ended December 31, 2016, five customers
accounted for 83% of product revenue, with Mitek alone accounting for 75% of product revenue. We expect to continue to be dependent
on a small number of large customers, especially Mitek, for the majority of our revenues for the foreseeable future. The failure of these
customers to purchase our products in the amounts they historically have or in amounts that we expect would seriously harm our
business.
In addition, if present and future customers terminate their purchasing arrangements with us, significantly reduce or delay their
orders, or seek to renegotiate their agreements on terms less favorable to us, our business, financial condition, and results of operations
will be adversely affected. If we accept terms less favorable than the terms of the current agreements, such renegotiations may have a
material adverse effect on our business, financial condition, and/or results of operations. Furthermore, in any future negotiations we may
be subject to the perceived or actual leverage that these customers may have given their relative size and importance to us. Any
termination, change, reduction, or delay in orders could seriously harm our business, financial condition, and results of operations.
Accordingly, unless and until we diversify and expand our customer base, or develop alternative commercial strategies, our future
success will significantly depend upon the timing and size of future purchases by our largest customers, and the financial and operational
success of these customers. The loss of any one of our major customers or the delay of significant orders from such customers, even if
only temporary, could reduce or delay our recognition of revenues, harm our reputation in the industry, and reduce our ability to
accurately predict cash flow, and, as a consequence, it could seriously harm our business, financial condition, and results of operations.
Information security breaches or business system disruptions may adversely affect our business.
We rely on our information technology infrastructure and management information systems to effectively run our business.
While we have not previously experienced a material information security breach caused by illegal hacking, computer viruses, or acts of
vandalism or terrorism, we may in the future be subject to such a breach. Our security measures or those of our third-party service
providers may not detect or prevent such breaches. Any such compromise to our information security could result in an interruption in
our operations, the unauthorized publication of our confidential business or proprietary information, the unauthorized release of
customer, vendor, or employee data, the violation of privacy, or other laws and exposure to litigation, any of which could harm our
business and operating results.
Our business may be adversely affected if consolidation in the healthcare industry leads to demand for price concessions or if we are
excluded from being a supplier by a group purchasing organization or similar entity.
Because healthcare costs have risen significantly over the past decade, numerous initiatives and reforms have been launched by
legislators, regulators, and third-party payers to curb these costs. As a result, there has been a consolidation trend in the healthcare
industry to create larger companies, including hospitals, with greater market power. As the healthcare industry consolidates, competition
to provide products and services to industry participants has become and may continue to become more intense. This may result in
greater pricing pressures and the exclusion of certain suppliers from important markets as group purchasing organizations, independent
delivery networks, and large single accounts continue to use their market power to consolidate purchasing decisions. If a group
purchasing organization excludes us from being one of their suppliers, our net sales could be adversely impacted. We expect that market
demand, government regulation, third-party reimbursement policies, and societal pressures will continue to change the worldwide
healthcare industry, which may exert further downward pressure on the prices of our products.
- 19 -
We experience quarterly sales volume variation, which makes our future results difficult to predict and makes period-to-period
comparisons potentially not meaningful.
We experience quarterly fluctuations in our products sales as a result of multiple factors, many of which are outside of our
control. These quarterly fluctuations create uncertainty as to the volume of sales that we may achieve in a given period. As a result,
comparing our operating results on a period-to-period basis might not be meaningful. You should not rely on our past results as an
indication of our future performance. Our operating results could be disproportionately affected by a reduction in revenue because a
proportionately smaller amount of our expenses varies with our revenue. As a result, our quarterly operating results are difficult to
predict, even in the near term.
Risks Related to Our Intellectual Property
We may be unable to adequately protect our intellectual property rights, which could have a material impact on our business and
future financial results.
Our efforts to enforce our intellectual property rights may not be successful. We rely on a combination of copyright, trademark,
patent, and trade secret laws, confidentiality procedures, and contractual provisions to protect our proprietary rights. Our success will
depend, in part, on our ability to obtain and enforce patents and trademarks, to protect trade secrets, to obtain licenses to technology
owned by third parties when necessary, and to conduct our business without infringing on the proprietary rights of others. The patent
positions of pharmaceutical, medical product, and biotechnology firms, including ours, can be uncertain and involve complex legal and
factual questions. There can be no assurance that any patent applications will result in the issuance of patents or, if any patents are
issued, that they will provide significant proprietary protection or commercial advantage or will not be circumvented by others. In the
event a third party has also filed one or more patent applications for any of its inventions, we may have to participate in interference
proceedings declared by the U.S. Patent and Trademark Office to determine priority of invention, which could result in the failure to
obtain, or the loss of, patent protection for the inventions and the loss of any right to use the inventions. Even if the eventual outcome is
favorable to us, such interference proceedings could result in substantial cost to us, including, but not limited to, the diversion of
management’s attention away from our other operations. Filing and prosecution of patent applications, litigation to establish the validity
and scope of patents, assertion of patent infringement claims against others, and the defense of patent infringement claims by others can
be expensive and time consuming. There can be no assurance that, in the event that any claims with respect to any of our patents, if
issued, are challenged by one or more third parties, any court or patent authority ruling on such challenge will determine that such patent
claims are valid and enforceable. An adverse outcome in such litigation could cause us to lose exclusivity covered by the disputed rights.
If a third party is found to have rights covering products or processes used by us, we could be forced to cease using the technologies or
marketing the products covered by such rights, we could be subject to significant liabilities to such third party, and we could be required
to license technologies from such third party in order to continue production of the products. Furthermore, even if our patents are
determined to be valid, enforceable, and broad in scope, there can be no assurance that competitors will not be able to design around
such patents and compete with us using the resulting alternative technology. We have a policy of seeking patent protection for patentable
aspects of our proprietary technology. We intend to seek patent protection with respect to products and processes developed in the
course of our activities when we believe such protection is in our best interest and when the cost of seeking such protection is not
inordinate. However, no assurance can be given that any patent application will be filed, that any filed applications will result in issued
patents, or that any issued patents will provide us with a competitive advantage or will not be successfully challenged by third parties.
The protections afforded by patents will depend upon their scope and validity, and others may be able to design around our patents.
We also rely upon trade secrets and proprietary know-how for certain non-patented aspects of our technology. To protect such
information, we require all employees, consultants, and licensees to enter into confidentiality agreements limiting the disclosure and use
of such information. There can be no assurance that these agreements provide meaningful protection or that they will not be breached,
that we would have adequate remedies for any such breach, or that our trade secrets, proprietary know-how, and our technological
advances will not otherwise become known to others. In addition, there can be no assurance that, despite precautions taken by us, others
have not and will not obtain access to our proprietary technology. Further, there can be no assurance that third parties will not
independently develop substantially equivalent or better technology.
There can be no assurance that we will not infringe upon the intellectual property rights of others, which could have a significant
impact on our business and financial results.
Other entities have filed patent applications for, or have been issued patents concerning, various aspects of HA-related products
or processes. There can be no assurance that the products or processes developed by us will not infringe on the patent rights of others in
the future. The cost of defending infringement suits is typically large, and there is no guarantee that any future defense would be
successful. In addition, infringement could lead to substantial damages payouts or our inability to produce or market certain of our
current or future products. As a result, any such infringement may have a material adverse effect on our business, financial condition,
and results of operations.
- 20 -
Risks Related to Ownership of Our Common Stock
Our stock price may be highly volatile, and we cannot assure you that market making in our common stock will continue.
The market price of shares of our common stock may be highly volatile. Factors such as announcements of new commercial
products or technological innovations by us or our competitors, disclosure of results of clinical testing or regulatory proceedings,
government regulation and approvals, developments in patent or other proprietary rights, public concern as to the safety of products
developed by us, and general market conditions may have a significant effect on the market price of our common stock. The trading
price of our common stock could be subject to wide fluctuations in response to quarter-to-quarter variations in our operating results,
material announcements by us or our competitors, governmental regulatory action, conditions in the health care industry generally or in
the medical products industry specifically, or other events or factors, many of which are beyond our control. In addition, the stock
market has experienced extreme price and volume fluctuations, which have particularly affected the market prices of many medical
products companies and which often have been unrelated to the operating performance of such companies. Our operating results in
future quarters may be below the expectations of equity research analysts and investors. In such an event, the price of our common stock
would likely decline, perhaps substantially.
If securities or industry analysts do not publish or cease publishing research or reports about us, our business, or our market, or if
they adversely change their recommendations regarding our stock, our stock price and trading volume could decline.
The trading market for our common stock is influenced by the research and reports that securities or industry analysts may
publish about us, our business, our market, or our competitors. No person is under any obligation to publish research or reports on us,
and any person publishing research or reports on us may discontinue doing so at any time without notice. If adequate research coverage
is not maintained on our company or if any of the analysts who cover us downgrade our stock or publish inaccurate or unfavorable
research about our business or provide relatively more favorable recommendations about our competitors, our stock price would likely
decline. If any analysts who cover us were to cease coverage of our company or fail to regularly publish reports on us, we could lose
visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.
We do not intend to pay dividends on our common stock in the foreseeable future.
We have never declared or paid any cash dividends on our common stock. We currently intend to retain earnings, if any, for use
in our business and do not anticipate paying cash dividends on our common stock in the foreseeable future. Accordingly, investors are
not likely to receive any dividends on their common stock in the foreseeable future, and their ability to achieve a return on their
investment will therefore depend on appreciation in the price of our common stock.
Our charter documents contain anti-takeover provisions that may prevent or delay an acquisition of our company.
Certain provisions of our Restated Articles of Organization and Amended and Restated By-laws could have the effect of
discouraging a third party from pursuing a non-negotiated takeover of us and preventing certain changes in control. These provisions
include a classified Board of Directors, advance notice to the Board of Directors of stockholder proposals, limitations on the ability of
stockholders to remove directors and to call stockholder meetings, and the provision that vacancies on the Board of Directors be filled
by vote of a majority of the remaining directors. In addition, the Board of Directors adopted a ten-year Shareholders Rights Plan in April
2008. We are also subject to Chapter 110F of the Massachusetts General Laws which, subject to certain exceptions, prohibits a
Massachusetts corporation from engaging in any of a broad range of business combinations with any “interested stockholder” for a
period of three years following the date that such stockholder becomes an interested stockholder. All of these provisions, policies, and
plans are reviewed periodically by our Board of Directors. These provisions could discourage a third party from pursuing a takeover of
us at a price considered attractive by many stockholders, since such provisions could have the effect of preventing or delaying a
potential acquirer from acquiring control of us and our Board of Directors.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
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ITEM 2. PROPERTIES
Our corporate headquarters is located in Bedford, Massachusetts, where we lease approximately 134,000 square feet of
administrative, research and development, and manufacturing space. We entered into this lease in January 2007, and the lease
commenced in May 2007 for an initial term of ten and a half years. We have an option under the lease to extend its terms for up to four
periods beyond the original expiration date subject to the condition that we notify the landlord that we are exercising each option at least
one year prior to the expiration of the original or then current term. The first three renewal options each extend the term an additional
five years with the final renewal option extending the term six years. In October 2016, we exercised the first of our four extension
options in accordance with the terms of the lease, which extended the lease term for a period of five years beginning in November 2017.
In February 2017, the extension, including the determination of a new annual base rent, was finalized.
Anika S.r.l. currently leases approximately 28,000 square feet of laboratory, warehouse, and office space in Abano Terme, Italy
from Fidia. The lease commenced in December 2009 for an initial term of six years, with the current lease being a subsequent six year
lease-term that Anika may terminate at any time by providing six months’ notice. In December 2016, following discussions between
Anika S.r.l. and Fidia, Anika S.r.l. notified Fidia of its intention to terminate this lease agreement as of March 2017.
In October 2015, Anika S.r.l. entered into a build-to-suit lease agreement for a new European headquarters facility consisting of
approximately 33,000 square feet of general office, research and development, training, and warehousing space located in Padova, Italy.
This lease has an initial term of fifteen years, which is expected to commence during the first quarter of 2017, in accordance with an
amendment to the lease agreement executed in February 2017. The lease will automatically renew for up to three additional six-year
terms, subject to certain terms and conditions. Anika S.r.l. may elect to early withdraw from this lease subject to certain financial
penalties after six years and with no penalties after the ninth year. The lease provides for an initial yearly rent of approximately $0.3
million.
In 2016, we had aggregate facility lease expenses of approximately $1.2 million. We believe that the capacity of our Bedford,
Massachusetts corporate headquarters is sufficient to satisfy our needs for the foreseeable future. We also believe that upon Anika
S.r.l.’s move into its new facility, the property will be sufficient to satisfy the needs of Anika S.r.l. for the foreseeable future.
ITEM 3. LEGAL PROCEEDINGS
On July 7, 2010, Genzyme Corporation filed a complaint against our company in the U.S. District Court for the District of
Massachusetts seeking unspecified damages and equitable relief. The complaint alleged that we infringed U.S. Patent No. 5,143,724 by
manufacturing MONOVISC in the United States for sale outside the United States and would infringe U.S. Patent Nos. 5,143,724 and
5,399,351 if we manufactured and sold MONOVISC in the United States. On March 7, 2014, we filed a joint motion with Genzyme to
lift the stay in Genzyme’s lawsuit against us and to dismiss with prejudice all of Genzyme’s claims. On March 10, 2014, the District
Court granted the motion to dismiss all of Genzyme’s claims against us with prejudice and the case was terminated.
We are also involved in various other legal proceedings arising in the normal course of business. Although the outcomes of
these other legal proceedings are inherently difficult to predict, we do not expect the resolution of these other legal proceedings to have a
material adverse effect on our financial position, results of operations, or cash flow.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
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PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY SECURITIES
Common Stock Information
Our common stock has traded on the NASDAQ Global Select Market since November 25, 1997, under the symbol “ANIK.”
The following table sets forth, for the periods indicated, the high and low sales prices of our common stock on the NASDAQ Global
Select Market. These prices represent prices between dealers and do not include retail mark-ups, markdowns, or commissions, and they
may not necessarily represent actual transactions.
Year Ended December 31, 2016
First Quarter
Second Quarter
Third Quarter
Fourth Quarter
Year Ended December 31, 2015
First Quarter
Second Quarter
Third Quarter
Fourth Quarter
$
$
High
Low
47.24 $
53.68
54.96
50.19
35.07
42.36
45.52
41.38
High
Low
45.35 $
41.30
39.24
43.82
37.05
31.36
30.93
30.94
At December 31, 2016, the closing price per share of our common stock was $48.96 as reported on the NASDAQ Global Select
Market, and there were 140 holders of record. We believe that the number of beneficial owners of our common stock at that date was
substantially greater, due to shares being held by intermediaries.
We have never declared or paid any cash dividends on our common stock. We currently intend to retain earnings, if any, for use
in our business and do not anticipate paying cash dividends on our common stock in the foreseeable future. Payment of future dividends,
if any, on our common stock will be at the discretion of our Board of Directors after taking into account various factors, including our
financial condition, operating results, anticipated cash needs, and plans for expansion.
Accelerated Share Repurchase Program
On February 26, 2016, we entered into an accelerated stock repurchase agreement with Morgan Stanley & Co. LLC (“Morgan
Stanley”) pursuant to a Fixed Dollar Accelerated Share Repurchase Transaction (“ASR Agreement") to purchase $25.0 million of shares
of its common stock. Pursuant to the terms of the ASR Agreement, we paid Morgan Stanley $25.0 million in cash and received an initial
delivery of 0.4 million shares of our common stock on February 29, 2016 based on a closing market price of $46.40 per share and the
applicable contractual discount.
On August 26, 2016, we settled the approximately $7.5 million remaining under the ASR Agreement, which was recorded as an
equity forward sale contract and was included in additional paid-in capital in stockholders' equity in the condensed consolidated balance
sheet as it met the criteria for equity accounting. Pursuant to the terms of the ASR Agreement, the final number of shares and the
average purchase price was determined at the end of the applicable purchase period, which was August 26, 2016. Based on the volume-
weighted average price since the effective date of the ASR Agreement less the applicable contractual discount, Morgan Stanley
delivered 0.1 million additional shares to us on August 31, 2016. In total, 0.5 million shares were repurchased under the ASR Agreement
at an average repurchase price of $47.08 per share. These shares are held by us as authorized but unissued shares pursuant to
Massachusetts law. The initial and final delivery of shares resulted in immediate reductions of the outstanding shares used to calculate
the weighted-average common shares outstanding for basic and diluted net income per share.
- 23 -
Performance Graph
Set forth below is a graph comparing the total returns of our company, the NASDAQ Composite Index, and the NASDAQ
Biotechnology Index. The graph assumes $100 is invested on December 31, 2010 in our common stock and each of the indices. Past
performance is not indicative of future results.
Anika Therapeutics, Inc.
NASDAQ Composite Index
NASDAQ Biotechnology Index
Dec-11
$
$
$
100.00 $
100.00 $
100.00 $
Dec-12
Dec-13
Dec-14
Dec-15
Dec-16
101.43 $
115.91 $
131.91 $
389.39 $
160.32 $
218.45 $
415.71 $
181.80 $
292.93 $
389.39 $
192.21 $
326.39 $
499.59
206.63
255.62
- 24 -
ITEM 6. SELECTED FINANCIAL DATA
The following selected consolidated financial data should be read in conjunction with the Consolidated Financial Statements
and the Notes thereto and the section captioned “Management’s Discussion and Analysis of Financial Condition and Results of
Operations” included elsewhere in this Annual Report on Form 10-K. The Balance Sheet Data at December 31, 2016 and 2015 and the
Statement of Operations Data for each of the three years ended December 31, 2016, 2015, and 2014 have been derived from the audited
Consolidated Financial Statements for such years, included elsewhere in this Annual Report on Form 10-K. The Balance Sheet Data at
December 31, 2014, 2013, and 2012, and the Statement of Operations Data for each of the two years in the period ended December 31,
2013 and 2012 have been derived from audited consolidated financial statements for such years not included in this Annual Report on
Form 10-K.
Statements of Operations Data:
Product revenue
Licensing, milestone and contract revenue
Total revenue
Cost of product revenue
Product gross profit
Product gross margin
Total operating expenses
Net income
Diluted net income per common share
Diluted common shares outstanding
Balance Sheet Data:
Cash, cash equivalents and investments
Working capital*
Total assets
Long-term liabilities
Retained earnings
Stockholders' equity
$
$
$
2016
102,932 $
447
103,379
24,027
78,905
77%
52,772
32,547
2.15 $
15,116
2016
Years ended December 31,
2014
(in thousands, except per share data)
2015
2013
87,696 $
5,303
92,999
21,053
66,643
76%
44,865
30,758
2.01 $
15,321
75,474 $
30,121
105,595
20,930
54,544
72%
44,148
38,319
2.51 $
15,269
71,774 $
3,307
75,081
22,765
49,009
68%
42,474
20,575
1.39 $
14,826
Years ended December 31,
2014
2015
2013
124,761 $
161,641
240,246
8,674
168,209
222,773
138,458 $
159,155
235,748
7,622
135,662
210,848
(in thousands)
106,906 $
131,863
192,808
8,737
104,904
178,098
63,333 $
84,650
156,042
11,125
66,584
135,634
2012
68,010
3,348
71,358
28,989
39,021
57%
51,643
11,757
0.82
14,345
2012
44,067
60,900
142,069
18,691
46,010
108,925
* In 2015, the Company adopted new accounting guidance related to the presentation of deferred income taxes, which has been applied above retrospectively. Current
deferred tax assets and liabilities have been reclassified as non-current deferred tax assets and liabilities.
- 25 -
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The following section contains statements that are not statements of historical fact and are forward-looking statements within
the meaning of the federal securities laws. These statements involve known and unknown risks, uncertainties, and other factors that may
cause our actual results, performance, or achievement to differ materially from anticipated results, performance, or achievement,
expressed or implied in such forward-looking statements. These statements reflect our current views with respect to future events, are
based on assumptions, and are subject to risks and uncertainties. We discuss many of these risks and uncertainties at the beginning of
this Annual Report on Form 10-K and under the sections captioned “Business” and “Risk Factors.” The following discussion should
also be read in conjunction with the consolidated financial statements and the Notes thereto appearing elsewhere in this Annual Report
on Form 10-K.
Management Overview
We are a global, integrated orthopedic medicines company committed to improving the lives of patients with degenerative
orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain
management to regenerative cartilage repair. We have over two decades of global expertise developing, manufacturing, and
commercializing products based on our proprietary HA technology. Our orthopedic medicine portfolio includes ORTHOVISC,
MONOVISC, and CINGAL, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid
HA-based scaffold to aid cartilage repair and regeneration.
Our therapeutic offerings consist of products in the following areas: Orthobiologics, Dermal, Surgical, and Other, which
includes our ophthalmic and veterinary products. All of our products are based on HA, a naturally occurring, biocompatible polymer
found throughout the body. Due to its unique biophysical and biochemical properties, HA plays an important role in a number of
physiological functions such as the protection and lubrication of soft tissues and joints, the maintenance of the structural integrity of
tissues, and the transport of molecules to and within cells.
Our proprietary technologies for modifying the HA molecule allow product properties to be tailored specifically to therapeutic
use. Our patented technology chemically modifies HA to allow for longer residence time in the body. We also offer products made from
HA based on two other technologies: HYAFF, which is a solid form of HA, and ACP gel, an autocross-linked polymer of HA. Our
technologies are protected by an extensive portfolio of owned and licensed patents.
Since our inception in 1992, we have utilized a commercial partnership model for the distribution of our products to end users.
Our strong, worldwide network of distributors has historically provided, and continues to provide, a solid foundation for our revenue
growth and territorial expansion. In 2015, we made the strategic decision to commercialize our next generation viscosupplementation
product, CINGAL, in the United States by utilizing a direct sales model, initially through the engagement of a contract sales
organization. Ultimately, we intend to transition the direct sales function into our company as part of a broader buildout of our
commercial capabilities. We believe that the combination of the direct and distribution commercial models will maximize the revenue
and profitability potential from our current and future product portfolio.
We began a strategic project in 2015 to move the manufacturing of our HYAFF-based products, which were previously
manufactured by a third party in Italy, to our Bedford, Massachusetts facility. Our main purposes behind this strategic move are to gain
control of our supply chain management, to improve the efficiency of our manufacturing process, and to enhance our research and
development capabilities, with the aim of accelerating future product development.
The following sections provide more information about our products:
Orthobiologics
Our orthobiologics business contributed 87% of our product revenue for the year ended December 31, 2016. Our orthobiologics
products primarily consist of viscosupplementation and regenerative orthopedic products. Our viscosupplementation products include
ORTHOVISC, ORTHOVISC mini, and MONOVISC, each of which is commercialized in various territories worldwide, and CINGAL,
which we launched internationally in Canada and the European Union in the second quarter of 2016 after receiving Health Canada and
CE Mark approval. ORTHOVISC is available in the United States, Canada, and some international markets for the treatment of
osteoarthritis of the knee, and in Europe and other international markets for the treatment of osteoarthritis in all joints. It has been
marketed by us in the United States since 2004 and internationally since 1996 through various distribution agreements. ORTHOVISC
mini is available in Europe and is designed for the treatment of osteoarthritis in small joints. MONOVISC is our first single injection
osteoarthritis treatment indicated for all joints in Europe and certain international markets, and for the knee in the United States, Turkey,
and Canada. ORTHOVISC mini and MONOVISC both became available in certain international markets through our network of
distributors during the second quarter of 2008, and the commercial introduction of MONOVISC in the United States occurred in April
2014. We are currently seeking regulatory approval for CINGAL, our second single-injection osteoarthritis product, in the United States.
- 26 -
We currently offer several orthopedic products used in connection with regenerative medicine. The products currently available
in Europe and certain international markets include HYALOFAST, a biodegradable support for human bone marrow mesenchymal stem
cells used for cartilage regeneration and as an adjunct for microfracture surgery; HYALONECT, a woven gauze used as a bone graft wrap;
and HYALOSS, HYAFF fibers used to mix blood/bone grafts to form a paste for bone regeneration. We also offer HYALOGLIDE, an
ACP gel used in tenolysis treatment that, with additional clinical data, may demonstrate potential for flexor tendon adhesion prevention
and for the treatment of adhesive capsulitis prevention in the shoulder. This product is commercialized through a network of distributors,
primarily in Europe, the Middle East, and Korea. We believe that the U.S. market offers excellent expansion potential to increase revenue
for these products, and this will continue to be a focus area for us moving forward.
Our strategy is to continue to add new products, to expand the indications for use of both our current and any new products, and
to expand our commercial reach. The orthobiologics area has been our fastest growing area, growing from 58% of our product revenue
in 2010 to 87% of our product revenue in 2016. We continue to seek new distribution partnerships around the world, in concert with
entering new markets with other appropriate sales strategies, and we expect total orthobiologics product sales to increase in 2017
compared to 2016 based mainly on increased sales to existing and new partners, as well as additional CINGAL product launches in
certain international countries and the commercial introduction of our ORTHOVISC-T product in certain jurisdictions. Additionally, if
we achieve FDA approval of CINGAL, we plan to utilize a direct sales model to commercialize the product in the United States initially
through the engagement of a contract sales organization with the ultimate goal of transitioning the direct sales function to our company
as part of a broader buildout of our commercial capabilities.
Dermal
Our dermal products contributed 3% to our product revenue for the year ended December 31, 2016 and consist of advanced
wound care products, which are based on the HYAFF technology, and an aesthetic dermal filler. We offer products for the treatment of
skin wounds ranging from burns to diabetic ulcers. The products cover a variety of wound treatment solutions including debridement
agents, advanced therapies, and scaffolds used as skin substitutes. Leading products include HYALOMATRIX and HYALOFILL for the
treatment of complex wounds, such as burns and ulcers, and for use in connection with the regeneration of skin. Our dermal products are
commercialized through a network of distributors, primarily in Europe, Latin America, and the Middle East. Several of the products are
also cleared for sale in the United States including HYALOMATRIX, HYALOFILL, HYALOGRAN, and HYALOMATRIX 3D. We
have a commercial partnership agreement with Medline Industries, Inc. to commercialize HYALOMATRIX in the United States on an
exclusive basis through 2019.
Our aesthetic dermatology product is a dermal filler based on our proprietary, chemically modified, cross-linked HA, and it is
approved in certain European Union countries, Canada, the United States, South Korea, and certain countries in South America and the
Middle East. Internationally, this product is marketed under the ELEVESS trade name. In the United States, the trade name is
HYDRELLE, although the product is not currently marketed in the United States.
Surgical
Our surgical group consists of products used to prevent surgical adhesions and to treat ENT disorders. For the year ended
December 31, 2016, sales of surgical products contributed 5% of our product revenue. HYALOBARRIER is a clinically proven post-
operative adhesion barrier for use in the abdomino-pelvic area. The product is currently commercialized in Europe, the Middle East, and
certain Asian countries through a distribution network, but it is not approved in the United States. INCERT, approved for sale in Europe,
Turkey, and Malaysia, is a chemically modified, cross-linked HA product used for the prevention of post-surgical spinal adhesions.
There are no plans at this time to distribute INCERT in the United States.
We also offer several products used in connection with the treatment of ENT disorders. The lead products are MEROGEL, a
woven fleece nasal packing, and MEROGEL INJECTABLE, a thick, viscous hydrogel composed of cross-linked HA, a biocompatible
agent that creates a moist wound-healing environment. We partner with Medtronic for the worldwide distribution of these products.
Other
Our other products include our ophthalmic and veterinary products, which constituted 5% of our product revenue for the year
ended December 31, 2016. These legacy products are not a part of our core business. Our ophthalmic business includes HA viscoelastic
products used in ophthalmic surgery. Sales of ophthalmic products contributed 2% of our product revenue and sales of HYVISC, our
veterinary product used for the treatment of equine osteoarthritis, contributed 3% to product revenue for the year ended December 31,
2016.
- 27 -
Research and Development
Our research and development efforts primarily consist of the development of new medical applications for our HA-based or
other technologies, the management of clinical trials for certain product candidates, the preparation and processing of applications for
regulatory approvals or clearances at all relevant stages of product development, and process development and scale-up manufacturing
activities for our existing and new products. Our development focus includes products for tissue protection, repair, and regeneration. For
the years ended December 31, 2016, 2015 and 2014, these expenses were $10.7 million, $9.0 million, and $8.1 million, respectively. We
anticipate that we will continue to commit significant resources to, and increase our aggregate spending on, research and development
activities, including in relation to clinical trials, in the future.
Our second single-injection osteoarthritis product under development in the United States is CINGAL, which is composed of
our proprietary cross-linked HA material combined with an approved steroid and is designed to provide both short- and long-term pain
relief to patients. We completed an initial CINGAL phase III clinical trial, including the associated statistical analysis for 368 enrolled
patients, during the fourth quarter of 2014 with data indicating that the product met all primary and secondary endpoints set forth for the
trial. During the first half of 2015, we completed a CINGAL retreatment study with 242 patients who had participated in the phase III
clinical trial and reported safety data related to the retreatment study. This initial phase III clinical trial and the associated retreatment
study supported the Health Canada and CE Mark approval of the product, and the commercial launch of the product in both Canada and
the European Union occurred in the second quarter of 2016. In the United States, after discussions with the FDA related to the
regulatory pathway for CINGAL, we conducted a formal meeting with OCP to present and discuss our data in September 2015, and we
submitted a formal request for designation with OCP a month later. In its response to our formal request for designation, OCP assigned
the product to CDER as the lead agency center for premarket review and regulation. Since then, we have been in ongoing discussions
with CDER to understand the requirements for submitting an NDA for CINGAL. We held a meeting with CDER at the end of
September 2016 to align on an approval framework and on submission requirements for this NDA for CINGAL, including the execution
of an additional Phase III clinical trial to supplement our strong, existing CINGAL pivotal study data. We submitted an IND in late
2016, and discussions with CDER to this point indicate that they do not have objections to our clinical protocol design. As a result, we
plan to commence this second phase III clinical trial in the first quarter of 2017 with the first patient to be treated in the second quarter
of 2017.
We have several research and development programs underway for new products, including for HYALOFAST (in the United
States), an innovative product for cartilage tissue repair, HYALOBONE, a bone void filler, and other early stage regenerative medicine
development programs. HYALOFAST received CE Mark approval in September 2009, and it is commercially available in Europe and
certain international countries. During the first quarter of 2015, we submitted an IDE for HYALOFAST to the FDA, which was
approved in July 2015. We commenced patient enrollment in a clinical trial in December 2015, and we are advancing site initiations and
patient enrollment activities. In the second quarter of 2016, a supplement to the HYALOFAST IDE was approved to expand the
inclusion criteria for the clinical study. The purpose of this supplement is to allow us to increase enrollment rates with the ultimate goal
of decreasing the time needed to complete the clinical trial. We are also currently proceeding with other research and development
programs, one of which utilizes our proprietary HA technology to treat pain associated with common repetitive overuse injuries, such as
lateral epicondylitis, also known as tennis elbow. We submitted a CE Mark application for this treatment during the first quarter of 2016
and received a CE Mark for the treatment of pain associated with tennis elbow in December 2016. Outside of the United States, this
product will be marketed under the trade name ORTHOVISC-T. Additionally, in the second quarter of 2016, we submitted an IDE to the
FDA to conduct a phase III clinical trial for this treatment, which was approved by the FDA in June 2016 and which we plan to
commence during the second half of 2017. We also have other research and development programs underway focused on expanding the
indications of our current products, including one program being conducted and funded by our U.S. MONOVISC distribution partner,
Mitek, seeking to expand MONOVISC’s indication to include treatment of pain associated with osteoarthritis of the hip.
In June 2015, we entered into an agreement with the Institute for Applied Life Sciences at the University of Massachusetts
Amherst to collaborate on research to develop a therapy for rheumatoid arthritis. The purpose of this research is to develop a novel
modality for the treatment of rheumatoid arthritis and, if successful, it is expected to yield a potential product candidate that we could
begin to move towards commercialization as early as 2017.
- 28 -
Summary of Critical Accounting Policies; Significant Judgments and Estimates
Our discussion and analysis of our financial condition and results of operations are based upon our consolidated financial
statements included elsewhere in this Annual Report on Form 10-K, which consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States. The preparation of these consolidated financial
statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and
the related disclosure of contingent assets and liabilities. We monitor our estimates on an on-going basis for changes in facts and
circumstances, and material changes in these estimates could occur in the future. Changes in estimates are recorded in the period in
which they become known. We base our estimates on historical experience and other assumptions that we believe to be reasonable under
the circumstances. Actual results may differ from our estimates if past experience or other assumptions do not turn out to be
substantially accurate.
We have identified the policies below as critical to our business operations and the understanding of our results of operations.
The impact and any associated risks related to these policies on our business operations are discussed throughout this section captioned
“Management’s Discussion and Analysis of Financial Condition and Results of Operations” where such policies affect our reported and
expected financial results. For a detailed discussion on the application of these and other accounting policies, see Note 2 to the
consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
Revenue Recognition - General
We recognize revenue from product sales when all of the following criteria are met: persuasive evidence of an arrangement
exists; delivery has occurred or services have been rendered; the seller's price to the buyer is fixed or determinable; and collection from
the customer is reasonably assured.
Product Revenue
Revenue from product sales is recognized when title and risk of loss have passed to the customer, which is typically upon
shipment to the customer. Amounts billed or collected prior to recognition of revenue are classified as deferred revenue. When
determining whether risk of loss has transferred to customers on product sales, or if the sales price is fixed or determinable, we evaluate
both the contractual terms and conditions of our distribution and supply agreements as well as our business practices.
Product revenue also includes royalties. Royalty revenue is based on our distributors’ sales and is recognized in the same period
our distributors record their sale of products manufactured by us. On a quarterly basis we record royalty revenue based upon estimated
or reported sales results provided to us by our distributor customers. If necessary, we adjust our estimates based upon final sales data
received prior to issuing our quarterly unaudited or annual audited financial statements.
Licensing, Milestone and Contract Revenue
Licensing, milestone and contract revenue consists of revenue recognized on initial and milestone payments, as well as
contractual amounts received from partners. Our business strategy includes entering into collaborative license, development, and/or
supply agreements with partners for the development and commercialization of our products.
The terms of the agreements typically include non-refundable license fees, funding of research and development, and payments
based upon achievement of certain milestones. Under ASC 605-25, Multiple Element Arrangements, in order to account for an element
as a separate unit of accounting, the element must have objective and reliable evidence of selling price of the undelivered elements. In
general, non-refundable upfront fees and milestone payments that do not relate to other elements are recognized as revenue over the term
of the arrangement as we complete our performance obligations.
Inventories
Inventories are stated at the lower of standard cost or net realizable value, with cost being determined using the first-in, first-out
method. Work-in-process and finished goods inventories include materials, labor, and manufacturing overhead. Inventory costs
associated with product candidates that have not yet received regulatory approval are capitalized if we believe there is probable future
commercial use and future economic benefit.
Our policy is to write-down inventory when conditions exist that suggest inventory may be in excess of anticipated demand or
is obsolete based upon assumptions about future demand for our products and market conditions. We regularly evaluate our ability to
realize the value of inventory based on a combination of factors including, but not limited to, historical usage rates, forecasted sales or
usage, product end of life dates, and estimated current or future market values. Purchasing requirements and alternative usage avenues
are explored within these processes to mitigate inventory exposure.
- 29 -
Goodwill and Acquired In-Process Research and Development
Goodwill is the amount by which the purchase price of acquired net assets in a business combination exceeded the fair values
of net identifiable assets on the date of acquisition. Acquired IPR&D represents the fair value assigned to research and development
assets that we acquire that have not been completed at the date of acquisition or are pending regulatory approval in certain jurisdictions.
The value assigned to the acquired IPR&D is determined by estimating the costs to develop the acquired technology into commercially
viable products, estimating the resulting revenue from the projects, and discounting the net cash flows to present value.
Goodwill and IPR&D are evaluated for impairment annually, or more frequently if events or changes in circumstances indicate
that the asset might be impaired. Factors we consider important, on an overall company basis, that could trigger an impairment review
include significant underperformance relative to historical or projected future operating results, significant changes in our use of the
acquired assets or the strategy for our overall business, significant negative industry or economic trends, a significant decline in our
stock price for a sustained period, or a reduction of our market capitalization relative to net book value.
To conduct impairment tests of goodwill, the fair value of the reporting unit is compared to its carrying value. If the reporting
unit’s carrying value exceeds its fair value, we record an impairment loss to the extent that the carrying value of goodwill exceeds its
implied fair value. Our annual assessment for impairment of goodwill as of November 30, 2016 indicated that the fair value of our
reporting unit exceeded the carrying value of the reporting unit.
To conduct impairment tests of IPR&D, the fair value of the IPR&D project is compared to its carrying value. If the carrying
value exceeds its fair value, we record an impairment loss to the extent that the carrying value of the IPR&D project exceeds its fair
value. We estimate the fair value for IPR&D projects using discounted cash flow valuation models, which require the use of significant
estimates and assumptions, including but not limited to, estimating the timing of and expected costs to complete the in-process projects,
projecting regulatory approvals, estimating future cash flows from product sales resulting from completed projects and in-process
projects, and developing appropriate discount rates. During the fourth quarter of 2015 we performed an impairment review of our
IPR&D projects as we reassessed our research and development strategy. We recorded an impairment charge of $0.7 million due to the
decision to discontinue further development efforts needed to commercialize our Hemostatic Patch in-process development project. Our
annual assessment for impairment of IPR&D indicated that the fair value of our other IPR&D assets as of November 30, 2016 exceeded
their respective carrying values.
Through December 31, 2016, there have not been any events or changes in circumstances that indicate that the carrying value
of goodwill or acquired intangible assets may not be recoverable. We continue to monitor and evaluate the financial performance of our
business, including the impact of general economic conditions, to assess the potential for the fair value of the reporting unit to decline
below its book value. There can be no assurance that, at the time future impairment tests are completed, a material impairment charge
will not be recorded.
Long-Lived Assets
Long-lived assets primarily include property and equipment, and intangible assets with finite lives. Our intangible assets are
comprised of purchased developed technologies, distributor relationships, patents, and a trade name. The distributor relationships and
trade name were fully amortized as of December 31, 2016. These intangible assets are carried at cost, net of accumulated amortization.
Amortization is recorded on a straight-line basis over the intangible assets' useful lives, which range from 5 to 16 years. We review long-
lived assets for impairment when events or changes in business circumstances indicate that the carrying amount of the assets may not be
fully recoverable or that the useful lives of those assets are no longer appropriate. Each impairment test is based on a comparison of the
undiscounted cash flows to the recorded value of the asset. If impairment is indicated, the asset is written down to its estimated fair value
based on a discounted cash flow analysis.
Stock-Based Compensation
We measure the compensation cost of award recipients’ services received in exchange for an award of equity instruments based
on the grant-date fair value of the underlying award. That cost is recognized over the period during which an employee is required to
provide service in exchange for the award. For performance based awards with financial achievement targets, we recognize expense
using the graded vesting methodology based on the number of shares expected to vest. Compensation cost associated with performance
grants is estimated using the Black-Scholes valuation method multiplied by the expected number of shares to be issued, which is
adjusted based on the estimated probabilities of achieving the performance goals. Changes to the probability assessment and the
estimated shares expected to vest will result in adjustments to the related share-based compensation expense that will be recorded in the
period of the change. If the performance targets are not achieved, no compensation cost is recognized and any previously recognized
compensation cost is reversed. See Note 12 to the consolidated financial statements included elsewhere in this Annual Report on Form
10-K for a description of the types of stock-based awards granted, the compensation expense related to such awards, and detail of
equity-based awards outstanding. See Note 16 to such consolidated financial statements for details related to the tax benefit recognized
in the consolidated statement of operations for stock-based compensation.
- 30 -
Income Taxes
Our income tax expense includes U.S. and international income taxes. Certain items of income and expense are not reported in
tax returns and financial statements in the same year. The tax effects of these differences are reported as deferred tax assets and
liabilities. Deferred tax assets are recognized for the estimated future tax effects of deductible temporary differences and tax operating
loss and credit carry-forwards. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. We assess
the likelihood that our deferred tax assets will be recovered from future taxable income and, to the extent we believe that it is more likely
than not that all or a portion of deferred tax assets will not be realized, we establish a valuation allowance. To the extent we establish a
valuation allowance or increase this allowance in a period, we include an expense within the tax provision in the consolidated statement
of operations.
- 31 -
Results of Operations
Year ended December 31, 2016 compared to year ended December 31, 2015
Statement of Operations Detail
Product revenue
Licensing, milestone and contract revenue
Total revenue
Operating expenses:
Cost of product revenue
Research & development
Selling, general & administrative
Total operating expenses
Income from operations
Interest income, net
Income before income taxes
Provision for income taxes
Net income
Product gross profit
Product gross margin
Years Ended December 31,
2016
2015
$ Inc/(Dec) % Inc/(Dec)
(in thousands, except percentages)
$
102,932 $
447
103,379
87,696 $
5,303
92,999
15,236
(4,856)
10,380
17%
(92%)
11%
24,027
10,732
18,013
52,772
50,607
263
50,870
18,323
32,547 $
78,905 $
77%
21,053
8,987
14,825
44,865
48,134
120
48,254
17,496
30,758 $
66,643 $
76%
2,974
1,745
3,188
7,907
2,473
143
2,616
827
1,789
12,262
14%
19%
22%
18%
5%
119%
5%
5%
6%
18%
$
$
Total revenue. Total revenue for the year ended December 31, 2016 increased by $10.4 million, as compared to the prior year,
to $103.4 million. This increase was primarily due to the growth of our orthobiologics franchise, specifically an increase in global
MONOVISC revenue, which was partially offset by our receipt of $5 million of milestone revenue in 2015 for the achievement of a
target MONOVISC U.S. end user sales threshold.
Product revenue by product line. Product revenue for the year ended December 31, 2016 was $102.9 million, an increase of
$15.2 million, or 17%, compared to the prior year. Product revenue increases in our Orthobiologics and Dermal franchises were partially
offset by moderate decreases in product revenue in our Surgical and Other franchises. Included in product revenue for the year ended
December 31, 2015 was approximately $1.8 million and $0.5 million of non-recurring revenue recorded in the second and third quarter
of 2015, respectively, related to a high end-user average selling price for MONOVISC products sold to our U.S. partner, Mitek, prior to
the fourth quarter of 2014. Products sold to Mitek after the third quarter of 2014 are not impacted by this arrangement, which will not
result in additional related revenue.
Orthobiologics
Dermal
Surgical
Other
Years Ended December 31,
2016
2015
$ Inc/(Dec) % Inc/(Dec)
$
$
89,695 $
2,759
5,427
5,051
102,932 $
73,247 $
2,266
5,812
6,371
87,696 $
16,448
493
(385)
(1,320)
15,236
22%
22%
(7%)
(21%)
17%
Revenue from our orthobiologics franchises increased $16.4 million, or 22%, in 2016 as compared to 2015. The growth in 2016
reflected a growing end-user demand, continued market penetration, increased revenue from worldwide MONOVISC sales, and
CINGAL revenue associated with the product’s commercial launch in Canada and Europe. ORTHOVISC and MONOVISC revenue in
the U.S. also increased 22% in 2016 as compared to 2015, while international viscosupplementation product revenue in 2016 increased
23% year-over-year. The increase in international viscosupplementation revenue in 2016 was driven primarily by increased sales of
MONOVISC resulting from a robust and growing end-user demand. We expect orthobiologics revenue to continue to grow in 2017, led
by increased global MONOVISC revenue, the continued territorial expansion of CINGAL, overall revenue growth from our
viscosupplementation franchise both domestically and internationally, and the introduction of our injectable HA treatment utilized to
treat the pain symptoms associated with chronic overuse injuries such as tennis elbow in the European Union and select other
geographies.
- 32 -
Dermal revenue increased $0.5 million, or 22%, in 2016 as compared to 2015. The increase primarily reflects revenue from the
agreement we entered into in July 2014 with Medline Industries, Inc. to commercialize HYALOMATRIX in the United States on an
exclusive basis through 2019. We expect dermal revenue to increase in 2017 as compared to 2016 primarily due to increased end user
demand and geographic expansion related to our advanced would care products, particularly in the U.S., European, and Latin American
markets.
Sales of our surgical products decreased slightly in 2016 as compared to 2015. The decrease of surgical product revenue was
primarily due to a decrease in sales generated by our ENT products and unfavorable impact from foreign currency exchange rate
fluctuations compared with the same periods in the prior year. Our surgical franchise consists primarily of our anti-adhesion products,
including INCERT and HYALOBARRIER, and our ENT offerings, of which MEROGEL is the leading product. We are partnered with
Medtronic for the worldwide distribution of our ENT products. We expect surgical product revenue to increase modestly in 2017 as
compared to 2016 primarily due to increased worldwide sales of our ENT products.
Other product revenue includes revenues from ophthalmic and veterinary products. The other product revenue decreased in
2016 from 2015 due to a decrease in sales generated by our veterinary and ophthalmic franchises. We expect other revenue to increase in
2017 as compared to 2016, primarily driven by higher ophthalmic revenue.
Licensing, milestone and contract revenue. Licensing, milestone and contract revenue for the year ended December 31, 2016
was $0.4 million, compared to $5.3 million for 2015. The year over year decrease was primarily the result of the recognition of licensing
and milestone revenue for the year ended December 31, 2015 of $5.0 million for the achievement of a milestone payment under the
Mitek MONOVISC Agreement. During the fourth quarter of 2015, we collected and fully recognized revenue for a milestone payment
of $5.0 million as a result of U.S. MONOVISC 12-month end-user sales exceeding $50 million. We expect that our licensing, milestone
and contract revenue will increase in 2017 compared to 2016 in large part due to an expected milestone achievement by us in 2017 in
relation to our commercial agreement with Mitek for MONOVISC in the United States.
Product gross profit and margin. Product gross profit for the year ended December 31, 2016 was $78.9 million, or 77% of
product revenue, as compared with $66.6 million, or 76% of product revenue, for the year ended December 31, 2015. The increase in
product gross profit was primarily due to improvements in the overall revenue mix compared to the prior year, with increased sales of
our higher-margin products as a percentage of our total product sales.
Research and development. Research and development expenses for the year ended December 31, 2016 increased by $1.7
million, or 19%, as compared to the prior year, mainly due to an increase in expenses for our HYALOFAST phase III clinical trial.
Included in our 2015 results was a $0.7 million expense resulting from an impairment charge related to IPR&D that was recorded in
connection with our acquisition of Anika S.r.l. The charge resulted from a decision to discontinue development of the acquired
Hemostatic Patch in-process development project. Research and development expense as a percentage of total revenue was 10% for the
years ended 2016 and 2015. Research and development spending is expected to increase in 2017 and thereafter compared to 2016 as we
further develop new products and line extensions and initiate new clinical trials based on our existing technology assets, including
CINGAL and HYALOFAST, as well as increase development activities for other products and line extensions in the pipeline.
Selling, general and administrative. Selling, general and administrative expenses for the year ended December 31, 2016
increased by $3.2 million, or 22%, as compared to 2015. The increase was primarily a result of increased headcount and external
professional fees. We expect selling, general and administrative expenses for 2017 will increase to reflect the support, including the
implementation of improved operational and financial technology platforms, required to grow our business both domestically and
internationally.
- 33 -
Income taxes. Provisions for income taxes were $18.3 million and $17.5 million for the years ended December 31, 2016 and
2015, respectively. The decrease in the effective tax rate in 2016 of 0.3%, as compared to 2015, is primarily due to an increased benefit
from research and development credits.
A reconciliation of the U.S. federal statutory tax rate to the effective tax rate for the periods ending December 31 is as follows:
Statutory federal income tax rate
State tax expense, net of federal benefit
Permanent items, including nondeductible expenses
State investment tax credit
Federal, state and foreign research and development credits
Foreign rate differential
Domestic production deduction
Effective income tax rate
Years ended December 31,
2016
35.0%
4.5%
0.5%
(0.1%)
(0.9%)
(0.1%)
(2.9%)
36.0%
2015
35.0%
4.8%
(0.3%)
0.0%
(0.4%)
0.1%
(2.9%)
36.3%
The decrease in permanent items, including nondeductible expenses, was mainly due to the impact on Anika S.r.l.’s long-term
deferred tax assets for the decrease in Italy’s tax rate, effective January 1, 2017. The increase in the federal, state and foreign research
and development credit was mainly due to increased qualified research and development expenses.
As of December 31, 2016, we had gross net operating losses (“NOL”) for income tax purposes in Italy of $5.2 million with no
expiration date. In connection with the preparation of the financial statements, we performed an analysis to ascertain if it was more
likely than not that we would be able to utilize, in future periods, the net deferred tax assets associated with our NOL carry-forward. We
have concluded that the positive evidence outweighs the negative evidence and, thus, that the deferred tax assets not otherwise subject to
a valuation allowance are realizable on a “more likely than not” basis. As such, we have not recorded a valuation allowance at December
31, 2016 or 2015.
Substantially all of our filings from 2013 through the present tax year remain subject to examination by the Internal Revenue
Service (“IRS”) and other taxing authorities for U.S. federal and state tax purposes. Our 2014 tax filing has been audited by the IRS and
closed. Our filings from 2010 through the present tax year remain subject to examination by the appropriate governmental authorities in
Italy.
Net income. For the year ended December 31, 2016, net income was $32.5 million, or $2.15 per diluted share, compared to
$30.8, or $2.01 per diluted share, for the same period in the prior year. The increase in net income and diluted earnings per share was
primarily a result of increased worldwide product revenue and improved operating margin.
- 34 -
Year ended December 31, 2015 compared to year ended December 31, 2014
Statement of Operations Detail
2015
Years Ended December 31,
$ Inc/(Dec)
2014
%Inc/(Dec)
Product revenue
Licensing, milestone and contract revenue
Total revenue
Operating expenses:
Cost of product revenue
Research & development
Selling, general & administrative
Total operating expenses
Income from operations
Interest income (expense), net
Income before income taxes
Provision for income taxes
Net income
Product gross profit
Product gross margin
$
$
$
87,696 $
5,303
92,999
(in thousands, except percentages)
12,222
(24,818)
(12,596)
75,474 $
30,121
105,595
21,053
8,987
14,825
44,865
48,134
120
48,254
17,496
30,758 $
66,643 $
76%
20,930
8,144
15,074
44,148
61,447
58
61,505
23,186
38,319 $
54,544 $
72 %
123
843
(249)
717
(13,313)
62
(13,251)
(5,690)
(7,561)
12,099
16%
(82%)
(12%)
1%
10%
(2%)
2%
(22%)
107%
(22%)
(25%)
(20%)
22%
Total revenue. Total revenue for the year ended December 31, 2015 decreased by $12.6 million to $93.0 million compared to
the prior year. Total revenue decreased primarily due to the recognition of approximately $29.7 million in milestone and contract
revenue recognized in the year ended December 31, 2014 associated with the Mitek MONOVISC Agreement, which was partially offset
by $5 million of milestone revenue received in 2015 for the achievement of a target MONOVISC U.S. end user sales threshold.
Product revenue by product line. Product revenue for the year ended December 31, 2015 was $87.7 million, an increase of
$12.2 million, or 16%, compared to the prior year. Product revenue increases in our Orthobiologics and Other franchises were partially
offset by moderate decreases in revenue as a result of the unfavorable impact from foreign currency exchange rate fluctuations. The
increases were also offset by decreases related to a former ophthalmic product supply agreement, which expired as expected at the end
of 2014. Included in product revenue for the year ended December 31, 2015 was approximately $1.8 million and $0.5 million of non-
recurring revenue recorded in the second and third quarter of 2015, respectively, related to a high end-user average selling price for
MONOVISC products sold to our U.S. partner, Mitek, prior to the fourth quarter of 2014. Products sold to Mitek after the third quarter
of 2014 are not impacted by this arrangement, which will not result in additional related revenue.
Years Ended December 31,
2015
2014
$ Inc/(Dec) % Inc/(Dec)
Orthobiologics
Dermal
Surgical
Other
$
$
(in thousands, except percentages)
11,290
932
(43)
43
12,222
61,957 $
1,334
5,855
6,328
75,474 $
73,247 $
2,266
5,812
6,371
87,696 $
18%
70%
(1%)
1%
16%
Revenue from our orthobiologics franchises increased $11.3 million, or 18%, in 2015 compared to 2014. The growth in 2015
reflected a growing end-user demand, continued market penetration, increased revenue from worldwide ORTHOVISC and worldwide
MONOVISC sales, as well as the non-recurring product revenue discussed in the prior section. Domestic ORTHOVISC and
MONOVISC end user sales increased 24% in 2015 compared to 2014. These increases were partially offset by decreases in product
sales to Mitek as a result of its planned reduction in inventory, which was completed during the third quarter of 2015. International
viscosupplementation product revenue in 2015 increased 42% compared to 2014. The increase in international revenue was driven
primarily by increased sales of MONOVISC and ORTHOVISC in 2015, as compared to 2014, resulting from growing end-user demand.
Dermal revenue increased $0.9 million, or 70%, in 2015 compared to 2014. The increase as compared to 2014 primarily reflected
revenue from the agreement we entered into in July 2014 with Medline Industries, Inc. to commercialize HYALOMATRIX in the United
States on an exclusive basis through 2019.
- 35 -
Sales of our surgical products decreased slightly in 2015 as compared to 2014. The decrease of surgical product revenue was
primarily due to the unfavorable impact from foreign currency exchange rate fluctuations compared with the same periods in the prior
year.
Other product revenue includes revenues from ophthalmic and veterinary products. The other product revenue decreased in
2015 from 2014 due to an increase in veterinary revenue, partially offset by a decrease in ophthalmic revenue.
Licensing, milestone and contract revenue. Licensing, milestone and contract revenue for the year ended December 31, 2015
was $5.3 million, compared to $30.1 million for 2014. The year over year decrease was primarily the result of the recognition of
licensing and milestone revenue for the year ended December 31, 2014 of $27.5 million for milestone payments related to development
obligations under the Mitek MONOVISC Agreement. It also included the recognition of approximately $2.2 million unamortized
upfront payments previously received in December 2011. The FDA’s approval of our MONOVISC product during the first quarter in
2014 completed the delivery of development obligations under the Mitek MONOVISC Agreement, and it resulted in the immediate
recognition of a $17.5 million milestone payment, as well as the full recognition of prior deferred revenue in that quarter. During the
second quarter of 2014, a $5.0 million milestone payment associated with the first commercial sale of MONOVISC in the United States
was also earned, received, and recognized as revenue. We also received a unique J-Code from the Centers for Medicare and Medicaid
Services for MONOVISC during the fourth quarter of 2014 and, as a result, we collected a milestone payment of $5.0 million which was
fully earned and recognized as revenue. For the year ended December 31, 2014, we recognized a total of $29.7 million in milestone
revenue related to MONOVISC. During the fourth quarter of 2015, we collected and fully recognized revenue for a milestone payment
of $5.0 million as a result of U.S. MONOVISC annual end-user sales exceeding $50 million.
Product gross profit and margin. Product gross profit for the year ended December 31, 2015 was $66.6 million, or 76% of
product revenue, compared with $54.5 million, or 72% of product revenue, for the year ended December 31, 2014. The increase in
product gross profit was primarily due to improved manufacturing efficiencies, as well as improvements in the overall product sales mix
compared to the prior year, with increased sales of our higher-margin orthobiologics products as a percentage of our total product sales.
Research and development. Research and development expenses for the year ended December 31, 2015 increased by $0.8
million, or 10%, as compared to the prior year, mainly due to a $0.7 million expense resulting from an impairment charge related to
IPR&D that was recorded in connection with our acquisition of Anika S.r.l. The charge resulted from a decision to discontinue
development of the acquired Hemostatic Patch in-process development project. Research and development expense as a percentage of
total revenue was 10% and 8% for the years ended 2015 and 2014, respectively.
Selling, general, and administrative. Selling, general, and administrative expenses for the year ended December 31, 2015
decreased by $249 thousand, or 2%, as compared to 2014. The decrease was primarily a result of the full amortization of certain
intangible assets on December 31, 2014, certain former employee termination and related expenses in 2014, as well as beneficial impact
from foreign currency exchange rate fluctuations.
Income taxes. Provisions for income taxes were $17.5 million and $23.2 million for the years ended December 31, 2015 and
2014, respectively. The decrease in the effective tax rate in 2015 of 1.4%, as compared to 2014, is primarily due to an increased benefit
from domestic production activities.
A reconciliation of the U.S. federal statutory tax rate to the effective tax rate for the periods ending December 31 is as follows:
Statutory federal income tax rate
State tax expense, net of federal benefit
Permanent items, including nondeductible expenses
State investment tax credit
Federal, state and foreign research and development credits
Foreign rate differential
Domestic production deduction
Effective income tax rate
Years ended December 31,
2015
35.0%
4.8%
(0.3%)
0.0%
(0.4%)
0.1%
(2.9%)
36.3%
2014
35.0%
4.9%
0.1%
(0.1%)
(0.7%)
0.2%
(1.7%)
37.7%
As of December 31, 2015, we had a gross NOL for income tax purposes in Italy of $6.3 million with no expiration date. In
connection with the preparation of the financial statements, we performed an analysis to ascertain if it was more likely than not that we
would be able to utilize, in future periods, the net deferred tax assets associated with our NOL carry-forward. We have concluded that
the positive evidence outweighs the negative evidence and, thus, that the deferred tax assets not otherwise subject to a valuation
allowance are realizable on a “more likely than not” basis. As such, we have not recorded a valuation allowance at December 31, 2015
or 2014.
- 36 -
Net income. For the year ended December 31, 2015, net income was $30.8 million, or $2.01 per diluted share, compared to
$38.3 million, or $2.51 per diluted share, for the same period in the prior year. The decrease in net income and diluted earnings per share
was primarily a result of the approximately $29.7 million in milestone and contract revenue recognized for the year ended December 31,
2014 associated with our U.S. license agreement for MONOVISC.
Concentration of Risk
We have historically derived the majority of our revenues from a small number of customers, most of whom resell our products
to end-users and most of whom are significantly larger companies than us. For the year ended December 31, 2016, five customers
accounted for 83% of product revenue, with Mitek alone accounting for 75% of product revenue. We expect to continue to be dependent
on a small number of large customers, especially Mitek, for the majority of our revenues for the foreseeable future, even with our
implementation of a direct sales model for CINGAL in the United States. The failure of these customers to purchase our products in the
amounts they historically have or in amounts that we expect would seriously harm our business.
In addition, if present and future customers terminate their purchasing arrangements with us, significantly reduce or delay their
orders, or seek to renegotiate their agreements on terms less favorable to us, our business, financial condition, and results of operations
will be adversely affected. If we accept terms less favorable than the terms of the current agreements, such renegotiations may have a
material adverse effect on our business, financial condition, and/or results of operations. Furthermore, in any future negotiations we may
be subject to the perceived or actual leverage that these customers may have given their relative size and importance to us. Any
termination, change, reduction, or delay in orders could seriously harm our business, financial condition, and results of operations.
Accordingly, unless and until we diversify and expand our customer base, our future success will significantly depend upon the timing
and size of future purchases by our largest customers and the financial and operational success of these customers. The loss of any one
of our major customers or the delay of significant orders from such customers, even if only temporary, could reduce or delay our
recognition of revenues, harm our reputation in the industry, and reduce our ability to accurately predict cash flow, and, as a
consequence, it could seriously harm our business, financial condition, and results of operations.
See Note 15, Revenue by Product Group, by Significant Customer and by Geographic Location; Geographic Information, to
the consolidated financial statements included elsewhere in this Annual Report on Form 10-K for information regarding significant
customers.
Liquidity and Capital Resources
We require cash to fund our operating expenses and to make capital expenditures. We expect that our requirements for cash to
fund these uses will increase as our operations expand. Historically we have generated positive cash flow from operations, which,
together with our available cash, investments, and debt, have met our cash requirements. Cash, cash equivalents and investments totaled
$124.8 million and $138.5 million, and working capital totaled $161.6 million and $159.2 million, at December 31, 2016 and December
31, 2015, respectively. We believe that we have adequate financial resources to support our business for at least the twelve months from
the issuance date of our financial statements.
Cash provided by operating activities was $23.8 million, $39.1 million and $40.0 million for 2016, 2015, and 2014,
respectively. The decrease in cash provided by operations was due primarily to decreases in accounts payable and income taxes payable
due to timing of payments. Cash provided by operations was also impacted by an increase in net working capital requirements as
compared to the same period in 2015 related to higher accounts receivable and inventory purchases due to increased revenue and
production.
Cash used in investing activities was $6.8 million, $30.2 million, and $8.3 million for 2016, 2015, and 2014, respectively. The
decrease in cash used in investing activities in 2016, as compared to the same period in the prior year, is a result of maturities of
investments and increased capital purchases associated with our Bedford, Massachusetts headquarters and manufacturing facility. The
increased capital purchases are part of our on-going project to establish additional manufacturing capabilities at the Bedford,
Massachusetts facility to manufacture our HYAFF-based products, which were previously manufactured by a third party in Italy. We
have incurred $21.6 million of capital expenditures as of December 31, 2016 and expect to expend a total of approximately $25 million
on this project with an estimated completion date in the second half of 2017.
Cash used in financing activities was $23.3 million for 2016, whereas cash provided by financing activities of $1.9 million and
$5.3 million for 2015 and 2014, respectively. The decrease in cash provided by financing activities compared to the same period in the
prior year was primarily attributable to the $25.0 million accelerated share repurchase program initiated in February 2016 and concluded
in August 2016. For a description of the accelerated share repurchase program, see “Market for Registrant’s Common Equity, Related
Stockholder Matters and Issuer Purchases of Equity Securities─Accelerated Share Repurchase Program.”
- 37 -
Contractual Obligations and Other Commercial Commitments
The table below summarizes our non-cancelable operating leases, purchase commitments and contractual obligations related to
future periods which are not reflected in our consolidated balance sheet at December 31, 2016. Purchase commitments relate primarily
to non-cancellable inventory commitments and capital expenditures entered in the normal course of business:
Operating Leases (1)
Purchase Commitments
Year Ended December 31, 2016
Total
11,837 $
16,533
28,370 $
$
$
Payments due by period (in thousands)
Less than
1 year
1 - 3 years
3 - 5 years
More than
5 years
1,454 $
16,329
17,783 $
3,736 $
204
3,940 $
3,784 $
-
3,784 $
2,863
-
2,863
(1)
(2)
Included in this line is a lease we entered into in January 2007, pursuant to which we lease our corporate headquarters facility,
which consists of approximately 134,000 square feet of general office, research and development, and manufacturing space
located in Bedford, Massachusetts. The lease has an initial term of ten and one-half years, and commenced in May 2007. In
February 2017, the Company finalized the exercise of its first option under the lease to extend the terms from November 1, 2017
through October 31, 2022, including the determination of a new annual base rent of $1.5 million which is included in the
disclosure above. No other terms of this lease were altered. The Company has an option under this lease to extend its lease-term
for up to three additional periods subject to the condition that the Company notify the landlord that the Company is exercising
each option at least one year prior to the expiration of the original or then-current term. The next two renewal options each
extend the term an additional five years, while the final renewal option extends the term by six years. Also included in this line
is a lease entered into pursuant to which Anika S.r.l. leases its Italian facility, which consists of approximately 28,000 square
feet of space. The lease commenced in December 2009 for a period of six years with certain extension options. In October 2015,
Anika S.r.l, entered into a build-to-suit lease agreement for a new European headquarters facility consisting of approximately
33,000 square feet of general office, research and development, training, and warehousing space located in Padova, Italy. This
lease has an initial term of fifteen years, which is expected to commence during the first quarter of 2017. The lease will
automatically renew for up to three additional six-year terms, subject to certain terms and conditions. The Company has the
ability to withdraw from this lease subject to certain financial penalties after six years and with no penalties after the ninth year.
As such, lease commitments through the ninth year are included in the table above. The lease provides for an initial yearly rent
of approximately $0.3 million. In December 2016, Anika S.r.l. notified Fidia of its intention to terminate the lease agreement
originally executed in December 2009 for the facility that serves as the current headquarters for Anika S.r.l. as of March 2017.
See the section captioned “Item 2—Properties” in this Annual Report on Form 10-K for additional discussion regarding these
leases.
Included in this line are purchase commitments for materials, clinical trials and other day to day business requirements.
- 38 -
Accounting for Off-Balance Sheet Arrangements
We do not use special purpose entities or other off-balance sheet financing techniques, except for operating leases as disclosed
in the contractual obligations table above, that we believe have or are reasonably likely to have a current or future material effect on our
financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, or capital resources.
Recent Accounting Pronouncements
A discussion of recent accounting pronouncements is included in Note 2 to the consolidated financial statements in this Annual
Report on Form 10-K.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Primary Market Risk Exposures
We manage our investment portfolio in accordance with our investment policy. The primary objectives of our investment
policy are to preserve principal, maintain a high degree of liquidity to meet operating and other needs, and obtain competitive returns
subject to prevailing market conditions without significantly increasing risk. To achieve this objective, we maintain our portfolio of cash
equivalents and investments in a variety of high quality securities, including money market funds, corporate bonds, and bank certificates
of deposits. The investments are classified as available-for-sale and consequently are recorded at fair value with unrealized gains or
losses reported as a separate component of accumulated other comprehensive income. Our portfolio of cash equivalents and investments
is subject to interest rate fluctuations, changes in credit quality of the issuer and other factors.
Foreign Exchange Risk
Our primary market risk exposures are in the area of currency exchange rate risk. We have two major supplier contracts
denominated in foreign currencies, and a significant portion of Anika S.r.l.’s revenue, and all of its operating expenses, are denominated
in Euros. Unfavorable fluctuations in exchange rates would have a negative impact on our financial statements. The impact of currency
exchange rate fluctuation for the two contracts on our financial statements was immaterial in 2016. Currently, we attempt to manage
foreign currency risk through the matching of assets and liabilities. In the future, we may undertake to manage foreign currency risk
through additional hedging methods. We recognize foreign currency gains or losses arising from our operations in the period incurred.
- 39 -
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
ANIKA THERAPEUTICS, INC. AND SUBSIDIARIES
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets as of December 31, 2016 and 2015
Consolidated Statements of Operations and Comprehensive Income for the Years Ended December 31, 2016, 2015 and 2014
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2016, 2015 and 2014
Consolidated Statements of Cash Flows for the Years Ended December 31, 2016, 2015 and 2014
Notes to Consolidated Financial Statements
41
42
43
44
45
46
- 40 -
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Anika Therapeutics, Inc.
In our opinion, the accompanying consolidated balance sheets and the related consolidated statements of operations and comprehensive
income, of stockholders' equity, and of cash flows present fairly, in all material respects, the financial position of Anika Therapeutics,
Inc. and its subsidiaries as of December 31, 2016 and December 31, 2015 and the results of their operations and their cash flows for each
of the three years in the period ended December 31, 2016 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, 2016, based on criteria established in Internal Control - Integrated Framework (2013) issued by the
Committee of Sponsoring Organizations of the Treadway Commission (COSO). The Company's management is responsible for these
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 appearing under
Item 9A. Our responsibility is to express opinions on these financial statements and on the Company's internal control over financial
reporting based on our integrated audits. We conducted our audits in accordance with the standards of the Public Company Accounting
Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about
whether the financial statements are free of material misstatement and whether effective internal control over financial reporting was
maintained in all material respects. Our audits of the financial statements included examining, on a test basis, evidence supporting the
amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by
management, and evaluating the overall financial statement presentation. 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.
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 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
Boston, Massachusetts
February 24, 2017
- 41 -
Anika Therapeutics, Inc. and Subsidiaries
Consolidated Balance Sheets
(in thousands, except per share data)
Current assets:
ASSETS
Cash and cash equivalents
Investments
Accounts receivable, net of reserves of $194 and $167 at December 31, 2016 and
December 31, 2015, respectively
Inventories
Prepaid expenses and other current assets
Total current assets
Property and equipment, net
Long-term deposits and other
Intangible assets, net
Goodwill
Total assets
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
Accrued expenses and other current liabilities
Income taxes payable
Total current liabilities
Other long-term liabilities
Long-term deferred revenue
Deferred tax liability
Commitments and contingencies (Note 11)
Stockholders’ equity:
Preferred stock, $0.01 par value; 1,250 shares authorized, no shares issued and
outstanding at December 31, 2016 and December 31, 2015, respectively
Common stock, $0.01 par value; 60,000 and 30,000 shares authorized, 14,627 and
15,037 shares issued and outstanding at December 31, 2016 and December 31, 2015,
respectively
Additional paid-in-capital
Accumulated other comprehensive loss
Retained earnings
Total stockholders’ equity
Total liabilities and stockholders’ equity
December 31,
2016
2015
104,261 $
20,500
27,598
15,983
2,098
170,440
52,296
69
10,227
7,214
240,246 $
2,303 $
6,496
-
8,799
2,078
48
6,548
110,707
27,751
21,652
14,938
1,385
176,433
40,108
69
11,656
7,482
235,748
8,302
4,778
4,198
17,278
781
66
6,775
-
-
146
61,735
(7,317)
168,209
222,773
240,246 $
150
81,685
(6,649)
135,662
210,848
235,748
$
$
$
$
The accompanying notes are an integral part of these consolidated financial statements.
- 42 -
Anika Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Operations and Comprehensive Income
(in thousands, except per share data)
For the Years Ended December 31,
2015
2016
2014
Product Revenue
Licensing, milestone and contract revenue
Total revenue
$
102,932 $
447
103,379
87,696 $
5,303
92,999
75,474
30,121
105,595
Operating expenses:
Cost of product revenue
Research & development
Selling, general & administrative
Total operating expenses
Income from operations
Interest income, net
Income before income taxes
Provision for income taxes
Net income
Basic net income per share:
Net income
Basic weighted average common shares outstanding
Diluted net income per share:
Net income
Diluted weighted average common shares outstanding
24,027
10,732
18,013
52,772
50,607
263
50,870
18,323
32,547 $
2.22 $
14,682
2.15 $
15,116
21,053
8,987
14,825
44,865
48,134
120
48,254
17,496
30,758 $
2.06 $
14,934
2.01 $
15,321
20,930
8,144
15,074
44,148
61,447
58
61,505
23,186
38,319
2.61
14,678
2.51
15,269
$
$
$
Net income
Other comprehensive loss:
Foreign currency translation adjustment
Comprehensive income
$
32,547 $
30,758 $
38,319
$
(668)
31,879 $
(2,154)
28,604 $
(2,796)
35,523
The accompanying notes are an integral part of these consolidated financial statements.
- 43 -
Total
Stockholders'
Equity
135,635
2,055
9,626
1,607
(1,699) $
-
-
-
-
-
(2,796)
(4,495) $
-
-
-
-
(2,154)
(6,649) $
-
-
-
-
-
(668)
(7,317) $
(6,348)
38,319
(2,796)
178,098
1,074
847
2,225
30,758
(2,154)
210,848
1,007
647
3,392
(25,000)
32,547
(668)
222,773
Anika Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Stockholders' Equity
(in thousands)
Number of
Shares
Common Stock
$.01 Par
Value
Additional Paid
in Capital
Accumulated
Other
Comprehensive
Loss
Retained
Earnings
Balance, December 31, 2013
Issuance of common stock for equity awards
Tax benefit related to equity awards
Stock-based compensation expense
Retirement of common stock for minimum tax
withholdings
Net income
Other comprehensive loss
Balance, December 31, 2014
Issuance of common stock for equity awards
Tax benefit related to equity awards
Stock-based compensation expense
Net income
Other comprehensive loss
Balance, December 31, 2015
Issuance of common stock for equity awards
Tax benefit related to equity awards
Stock-based compensation expense
Repurchase of common stock
Net income
Other comprehensive loss
Balance, December 31, 2016
14,289 $
697
-
-
(134)
-
-
14,852 $
185
-
-
-
-
15,037 $
121
-
-
(531)
-
-
14,627 $
143 $
7
-
-
(1)
-
-
149 $
1
-
-
-
-
150 $
1
-
-
(5)
-
-
146 $
70,606 $ 66,585 $
-
2,048
-
9,626
-
1,607
(6,347)
-
- 38,319
-
-
77,540 $104,904 $
-
1,073
-
847
-
2,225
- 30,758
-
-
81,685 $135,662 $
-
1,006
-
647
-
3,392
-
(24,995)
- 32,547
-
-
61,735 $168,209 $
The accompanying notes are an integral part of these consolidated financial statements.
- 44 -
Anika Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(in thousands)
For the years ended December 31,
2015
2016
2014
$
32,547 $
30,758 $
38,319
Cash flows from operating activities:
Net income
Adjustments to reconcile net income to net cash provided by
operating activities:
Depreciation and amortization
Stock-based compensation expense
Deferred income taxes
Provision for doubtful accounts
Provision for inventory
Non-cash impairment charges for IPR&D
Tax benefit from equity awards
Changes in operating assets and liabilities:
Accounts receivable
Inventories
Prepaid expenses, other current and long-term assets
Accounts payable
Accrued expenses and other current liabilities
Deferred revenue
Income taxes payable
Other long-term liabilities
Net cash provided by operating activities
Cash flows from investing activities:
Proceeds from maturity of investments
Purchase of investments
Purchase of property and equipment, net
Net cash used in investing activities
Cash flows from financing activities:
Repurchase of common stock
Proceeds from exercise of equity awards
Tax benefit from equity awards
Minimum tax withholdings on share-based awards
Net cash (used in) provided by financing activities
3,734
3,392
(65)
52
654
-
(647)
(6,201)
(1,738)
(898)
(5,059)
1,566
(50)
(3,552)
66
23,801
46,500
(39,249)
(14,014)
(6,763)
(25,000)
1,007
647
-
(23,346)
3,775
2,225
(747)
38
210
697
(847)
(4,996)
(2,939)
89
5,625
(199)
(15)
5,484
(94)
39,064
24,250
(45,251)
(9,225)
(30,226)
-
1,074
847
-
1,921
4,706
1,607
815
-
378
-
(9,626)
898
(1,974)
585
(750)
(1,189)
(2,014)
8,436
(213)
39,978
20,000
(26,750)
(1,553)
(8,303)
-
2,055
9,626
(6,349)
5,332
(184)
Exchange rate impact on cash
(138)
(208)
Increase (Decrease) in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period
Supplemental disclosure of cash flow information:
Cash paid for income taxes
Non-cash Investing Activities:
(6,446)
110,707
104,261 $
10,551
100,156
110,707 $
36,823
63,333
100,156
22,826 $
12,724 $
13,778
$
$
Purchases of property and equipment included in accounts payable
and accrued expenses
Build-to-suit lease agreement
$
$
1,257 $
1,723 $
1,949 $
30 $
52
-
The accompanying notes are an integral part of these consolidated financial statements.
- 45 -
Anika Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share amounts or as otherwise noted)
1. Nature of Business
Anika Therapeutics, Inc. is a global, integrated orthopedic medicines company committed to improving the lives of patients
with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from
palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing,
manufacturing, and commercializing products based on the Company’s proprietary HA technology. The Company’s orthopedic
medicine portfolio includes ORTHOVISC, MONOVISC, and CINGAL, which alleviate pain and restore joint function by replenishing
depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration.
The Company is subject to risks common to companies in the biotechnology and medical device industries including, but not
limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, protection
of proprietary technology, commercialization of existing and new products, and compliance with FDA and foreign regulations and
approval requirements, as well as the ability to grow the Company’s business through appropriate commercial strategies.
2. Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with generally accepted accounting principles in the United States of
America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses
during the reporting period. Actual results could differ from those estimates.
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of Anika Therapeutics, Inc. and its wholly owned
subsidiaries, Anika Securities, Inc. (a Massachusetts Securities Corporation), and Anika Therapeutics S.r.l. All intercompany balances
and transactions have been eliminated in consolidation.
Foreign Currency Translation
The functional currency of the Company’s foreign subsidiary is the Euro. Assets and liabilities of the foreign subsidiary are
translated using the exchange rate existing on each respective balance sheet date. Revenues and expenses are translated using the monthly
average exchange rates prevailing throughout the year. The translation adjustments resulting from this process are included as a component
of accumulated currency translation adjustment which resulted in a loss from foreign currency translation of $0.7 million, $2.2 million,
and $2.8 million for the years ended December 31, 2016, 2015, and 2014, respectively.
The Company recognized a loss from foreign currency transactions of $0.3 million, $0.4 million, and $0.6 million during the
years ended December 31, 2016, 2015, and 2014, respectively.
Fair Value Measurements
Fair value is defined as the price that would be received from selling an asset, or paid to transfer a liability, in an orderly
transaction between market participants at the measurement date. When determining the fair value measurements for assets and
liabilities required to be recorded at fair value, the Company considers the principal or most advantageous market in which it would
transact and consider assumptions that market participants would use when pricing the asset or liability, such as inherent risk, transfer
restrictions and risk of non-performance. The accounting standard establishes a fair value hierarchy that requires an entity to maximize
the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.
- 46 -
A financial instrument’s categorization within the fair value hierarchy is based upon the lowest level of input that is significant
to the fair value measurement. Three levels of inputs that may be used to measure fair value are:
• Level 1 – Valuation is based upon quoted prices for identical instruments traded in active markets. Level 1 instruments include
securities traded on active exchange markets, such as the New York Stock Exchange.
• Level 2 – Valuation is based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar
instruments in markets that are not active and model-based valuation techniques for which all significant assumptions are
directly observable in the market.
• Level 3 – Valuation is generated from model-based techniques that use significant assumptions not observable in the market.
These unobservable assumptions reflect the Company’s own estimates of assumptions market participants would use in pricing
the instrument.
The Company’s financial assets have been classified as Level 2. The Company’s financial assets (which include cash
equivalents and investments) have been initially valued at the transaction price and subsequently valued, at the end of each reporting
period, utilizing third party pricing services or other market observable data.
Allowance for Doubtful Accounts
The Company maintains an allowance for doubtful accounts for estimated losses resulting from the inability of its customers to
make required payments, which is included in selling, general and administrative expenses in the accompanying consolidated statements
of operations. In determining the adequacy of the allowance for doubtful accounts, management specifically analyzes individual
accounts receivable, historical bad debts, customer concentrations, customer credit-worthiness, current economic conditions, accounts
receivable aging trends, and changes in the Company’s customer payment terms. A summary of activity in the allowance for doubtful
accounts is as follows:
Balance, beginning of the year
Amounts provided
Amounts written off
Translation adjustments
Balance, end of the year
Revenue Recognition - General
2016
December 31,
2015
2014
$
$
167 $
52
(16)
(9)
194 $
147 $
38
(3)
(15)
167 $
593
-
(377)
(69)
147
The Company recognizes revenue when all of the following criteria are met: persuasive evidence of an arrangement exists, risk
of loss has passed or services have been rendered, the seller's price to the buyer is fixed or determinable, and collection from the
customer is reasonably assured.
Product Revenue
Revenues from product sales are recognized when title and risk of loss have passed to the customer, which is typically upon
shipment to the customer. Amounts billed or collected prior to recognition of revenue are classified as deferred revenue. When
determining whether risk of loss has transferred to customers on product sales, or if the sales price is fixed or determinable, the
Company evaluates both the contractual terms and conditions of its distribution and supply agreements as well as its business practices.
Product revenue also includes royalties. Royalty revenue is based on distributors’ sales and recognized in the same period
distributors record their sale of products manufactured by the Company. On a quarterly basis the Company records royalty revenue
based upon sales provided to it by its distributor customers.
Pursuant to the Health Care and Education Reconciliation Act of 2010, in conjunction with the Patient Protection and
Affordable Care Act, a medical device excise tax (“MDET”) became effective on January 1, 2013 for sales of certain medical devices.
Some of the Company’s product sales are subject to the provisions of the MDET. The Company has elected to recognize any amounts
related to the MDET under the gross method as allowed under ASC 605-45. For the periods ended December 31, 2015 and 2014,
amounts included in revenues and costs of goods sold for the MDET were immaterial. On December 18, 2015, President Obama signed
the Consolidated Appropriations Act of 2016, which suspends the 2.3 percent MDET beginning on January 1, 2016, with the suspension
ending on December 31, 2017.
- 47 -
Licensing, Milestone and Contract Revenue
Licensing, milestone and contract revenue consist of revenue recognized on initial and milestone payments, as well as contractual
amounts received from partners. The Company’s business strategy includes entering into collaborative license, development, and/or
supply agreements with partners for the development and commercialization of the Company’s products. Under the milestone method,
the Company recognizes a consideration that is contingent upon the achievement of a milestone in its entirety as revenue in the period in
which the milestone is achieved only if the milestone is substantive in its entirety. A milestone is considered substantive when it meets
all of the following criteria:
1. The consideration is commensurate with either the entity’s performance to achieve the milestone or the enhancement of the
value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone,
2. The consideration relates solely to past performance, and
3. The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement.
A milestone is defined as an event (i) that can only be achieved based in whole or in part on either the entity’s performance or
on the occurrence of a specific outcome resulting from the entity’s performance, (ii) for which there is substantive uncertainty at the date
the arrangement is entered into that the event will be achieved, and (iii) that would result in additional payments being due to the
Company. Non substantive milestones are recognized when there are no further obligations by the Company.
The terms of the agreements typically include non-refundable license fees, funding of research and development and payments
based upon achievement of certain milestones. The Company adopted ASU 2009-13, Revenue Recognition in January 2011, which
amends ASC Subtopic 605-25, Multiple Element Arrangements (“ASC 605-25”) to require the establishment of a selling price hierarchy
for determining the allocable selling price of an item. Under ASC 605-25, as amended by ASU 2009-13, in order to account for an
element as a separate unit of accounting, the element must have objective and reliable evidence of selling price of the undelivered
elements. In general, non-refundable up-front fees and milestone payments that do not relate to other elements are recognized as revenue
over the term of the arrangement as the Company completes its performance obligations.
Cash and Cash Equivalents
The Company considers only those investments which are highly liquid, readily convertible to cash, and that mature within
three months from date of purchase to be cash equivalents. The Company’s cash equivalents consist of money market funds and bank
certificates of deposit with an original maturity of less than 90 days.
Investments
The Company’s investments consist of bank certificates of deposit with an original maturity of more than 90 days. The
Company has designated all investments as available-for-sale, and therefore such investments are reported at fair value, with unrealized
gains and losses recorded in accumulated other comprehensive income. For securities sold prior to maturity, the cost of securities sold is
based on the specific identification method. Realized gains and losses on the sale of investments are recorded in interest income, net.
Interest is recorded when earned. Investments with original maturities greater than approximately three months and remaining maturities
less than one year are classified as short-term investments. Investments with remaining maturities greater than one year are classified as
long-term investments. The Company considers securities with maturities of three months or less from the purchase date to be cash
equivalents.
All of the Company’s investments are subject to a periodic impairment review. The Company recognizes an impairment charge
when a decline in the fair value of its investments below the cost basis is judged to be other-than-temporary. Factors considered in
determining whether a loss is temporary include the extent and length of time the investment's fair value has been lower than its cost
basis, the financial condition and near-term prospects of the investee, extent of the loss related to credit of the issuer, the expected cash
flows from the security, the Company’s intent to sell the security, and whether or not the Company will be required to sell the security
prior the expected recovery of the investment's amortized cost basis. During the years ended December 31, 2016 and 2015, the Company
did not record any other-than-temporary impairment charges on its available-for-sale securities because the Company does not intend to
sell the securities and it is not more likely than not that the Company will be required to sell these securities before the recovery of their
amortized cost basis.
- 48 -
Concentration of Credit Risk and Significant Customers
The Company has no significant off-balance sheet risks related to foreign exchange contracts, option contracts, or other foreign
hedging arrangements. The Company’s cash equivalents and investments are held with two major international financial institutions.
The Company, by policy, routinely assesses the financial strength of its customers. As a result, the Company believes that its
accounts receivable credit risk exposure is limited.
As of December 31, 2016 and 2015, DePuy Synthes Mitek Sports Medicine (“Mitek”), represented 66% and 60%, respectively,
of the Company’s accounts receivable balance, no other single customer accounted for more than 10% of accounts receivable in either
period.
Inventories
Inventories are stated at the lower of standard cost or net realizable value, with cost being determined using the first-in, first-out
method. Work-in-process and finished goods inventories include materials, labor, and manufacturing overhead. Inventory costs
associated with product candidates that have not yet received regulatory approval are capitalized if the Company believes there is
probable future commercial use and future economic benefit.
The Company’s policy is to write-down inventory when conditions exist that suggest inventory may be in excess of anticipated
demand or is obsolete based upon assumptions about future demand for the Company’s products and market conditions. The Company
regularly evaluates the ability to realize the value of inventory based on a combination of factors including, but not limited to, historical
usage rates, forecasted sales or usage, product end of life dates, and estimated current or future market values. Purchasing requirements
and alternative usage avenues are explored within these processes to mitigate inventory exposure.
When recorded, inventory write-downs are intended to reduce the carrying value of inventory to its net realizable value.
Inventory of $16.0 million and $14.9 million as of December 31, 2016 and 2015, respectively, is stated net of inventory reserves of
approximately $0.9 million and $0.9 million, respectively. If actual demand for the Company’s products deteriorates, or if market
conditions are less favorable than those projected, additional inventory write-downs may be required.
Property and Equipment
Property and equipment are recorded at cost and depreciated using the straight-line method over their estimated useful lives.
Equipment and software are typically amortized over two to ten years, and furniture and fixtures over five to seven years. Leasehold
improvements are amortized over the shorter of their useful lives or the remaining terms of the related leases. Maintenance and repairs
are charged to expense when incurred; additions and improvements are capitalized. When an item is sold or retired, the cost and related
accumulated depreciation is relieved, and the resulting gain or loss, if any, is recognized in income. Construction-in-process is stated at
cost, which includes the cost of construction and other direct costs attributable to the construction. Construction-in-process is not
depreciated until such time as the relevant assets are completed and put into use. Construction-in-process at December 31, 2016 and
2015 primarily represents the costs of machinery and equipment under installation.
Goodwill and Acquired Intangible Assets
Goodwill is the amount by which the purchase price of acquired net assets in a business combination exceeded the fair values
of net identifiable assets on the date of acquisition. Acquired IPR&D represents the fair value assigned to research and development
assets that the Company acquires that have not been completed at the date of acquisition or are pending regulatory approval in certain
jurisdictions. The value assigned to the acquired IPR&D is determined by estimating the costs to develop the acquired technology into
commercially viable products, estimating the resulting revenue from the projects, and discounting the net cash flows to present value.
Goodwill and IPR&D are evaluated for impairment annually or more frequently if events or changes in circumstances indicate
that the asset might be impaired. Factors the Company considers important, on an overall company basis, that could trigger an
impairment review include significant underperformance relative to historical or projected future operating results, significant changes
in the Company’s use of the acquired assets or the strategy for its overall business, significant negative industry or economic trends, a
significant decline in the Company’s stock price for a sustained period, or a reduction of its market capitalization relative to net book
value.
To conduct impairment tests of goodwill, the fair value of the reporting unit is compared to its carrying value. If the reporting
unit’s carrying value exceeds its fair value, the Company records an impairment loss to the extent that the carrying value of goodwill
exceeds its implied fair value. The Company’s annual assessment for impairment of goodwill as of November 30, 2016 indicated that
the fair value of its reporting unit exceeded the carrying value of the reporting unit.
- 49 -
To conduct impairment tests of IPR&D, the fair value of the IPR&D project is compared to its carrying value. If the carrying
value exceeds its fair value, the Company records an impairment loss to the extent that the carrying value of the IPR&D project exceeds
its fair value. The Company estimates the fair value for IPR&D projects using discounted cash flow valuation models, which require the
use of significant estimates and assumptions, including but not limited to, estimating the timing of and expected costs to complete the in-
process projects, projecting regulatory approvals, estimating future cash flows from product sales resulting from completed projects and
in-process projects, and developing appropriate discount rates. During the fourth quarter of 2015, the Company performed an
impairment review of its IPR&D projects as it reassessed its research and development strategy. The Company recorded an impairment
charge of $0.7 million due to the decision to discontinue further development efforts needed to commercialize the Hemostatic Patch in-
process development project. The Company’s annual assessment for impairment of IPR&D indicated that the fair value of its other
IPR&D assets as of November 30, 2016 exceeded their respective carrying values.
Long-Lived Assets
Long-lived assets primarily include property and equipment, and intangible assets with finite lives. The Company’s intangible
assets are comprised of purchased developed technologies, distributor relationships, patents and trade names. These intangible assets are
carried at cost, net of accumulated amortization. Amortization is recorded on a straight-line basis over the intangible assets' useful lives,
which range from approximately five to sixteen years. The Company reviews long-lived assets for impairment when events or changes
in business circumstances indicate that the carrying amount of the assets may not be fully recoverable or that the useful lives of those
assets are no longer appropriate. Each impairment test is based on a comparison of the undiscounted cash flows to the recorded value of
the asset. If impairment is indicated, the asset is written down to its estimated fair value based on a discounted cash flow analysis.
Research and Development
Research and development costs consist primarily of clinical trials, salaries and related expenses for personnel, and fees paid to
outside consultants and outside service providers, including costs associated with licensing, milestone and contract revenue. Research
and development costs are expensed as incurred.
Stock-Based Compensation
The Company has stock-based compensation plans under which various types of equity-based awards are granted, including
restricted stock units (“RSUs”), restricted stock awards (“RSAs”), performance units, and stock options. The Company measures the
compensation cost of award recipients’ services received in exchange for an award of equity instruments based on the grant date fair
value of the underlying award. That cost is recognized over the period during which an employee is required to provide service in
exchange for the award. See Note 12 for a description of the types of stock-based awards granted, the compensation expense related to
such awards, and detail of equity-based awards outstanding.
For performance-based awards with financial achievement targets, the Company recognizes expense using the graded vesting
methodology based on the number of shares expected to vest. Compensation cost associated with these grants was estimated using the
Black-Scholes valuation method multiplied by the expected number of shares to be issued, which is adjusted based on the estimated
probabilities of achieving the performance goals. Changes to the probability assessment and the estimated shares expected to vest will
result in adjustments to the related share-based compensation expense that will be recorded in the period of the change. If the
performance targets are not achieved, no compensation cost is recognized, and any previously recognized compensation cost is reversed.
The Company recorded approximately $0.3 million and $0.4 million related to performance-based awards in 2016 and 2015,
respectively. There was no expense recognized on performance based awards in 2014 as satisfaction of the performance conditions were
not considered probable.
- 50 -
Income Taxes
The Company’s income tax expense includes U.S. and international income taxes. Certain items of income and expense are not
reported in tax returns and financial statements in the same year. The tax effects of these timing differences are reported as deferred tax
assets and liabilities. Deferred tax assets are recognized for the estimated future tax effects of deductible temporary differences, tax
operating losses, and tax credit carry-forwards (including investment tax credits). Changes in deferred tax assets and liabilities are
recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from
future taxable income and, to the extent it believes that it is more likely than not that all or a portion of deferred tax assets will not be
realized, the Company establishes a valuation allowance to reduce the deferred tax assets to the appropriate valuation. To the extent the
Company establishes a valuation allowance or increases or decreases this allowance in a given period, it includes the related tax expense
or tax benefit within the tax provision in the consolidated statement of operations in that period.
Comprehensive Income
Comprehensive income consists of net income and other comprehensive loss, which includes foreign currency translation
adjustments. For the purposes of comprehensive income disclosures, the Company does not record tax provisions or benefits for the net
changes in the foreign currency translation adjustment, as it intends to indefinitely reinvest undistributed earnings of its foreign
subsidiary. Accumulated other comprehensive loss is reported as a component of stockholders' equity.
Segment Information
Operating segments are components of an enterprise about which separate financial information is available that is evaluated
regularly by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing
performance. The Company’s chief operating decision maker is its Chief Executive Officer. Based on the criteria established by ASC
280, Segment Reporting, the Company has one reportable operating segment, the results of which are disclosed in the accompanying
consolidated financial statements.
Contingencies
In the normal course of business, we are involved in various legal proceedings and other matters such as contractual disputes,
which are complex in nature and have outcomes that are difficult to predict. We record accruals for loss contingencies to the extent that
we conclude that it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. We
consider all relevant factors when making assessments regarding these contingencies. Although the outcomes of these other legal
proceedings are inherently difficult to predict, the Company does not expect the resolution of these other legal proceedings to have a
material adverse effect on its financial position, results of operations, or cash flow.
Subsequent Events
Events occurring subsequent to December 31, 2016 have been evaluated for potential recognition or disclosure in the
consolidated financial statements. See Note 11, Commitments and Contingencies, to the consolidated financial statements for
information regarding the February 2, 2017 lease extension of the Company’s headquarters facility located in Bedford, Massachusetts.
- 51 -
Recent Accounting Pronouncements
Recently Issued
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-
09, Revenue from Contracts with Customers. ASU 2014-09 supersedes the revenue recognition requirements in “Topic 605, Revenue
Recognition” and requires entities to recognize revenue in a way that depicts the transfer of promised goods or services to customers in
an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In July 2015,
the FASB issued a deferral of ASU 2014-09 of one year making it effective for annual reporting periods beginning on or after December
15, 2017 while also providing for early adoption not to occur before the original effective date. The Company is assessing the
appropriate method for implementing ASU 2014-09, as well as the impact the adoption of ASU 2014-09 will have on its consolidated
financial statements and footnote disclosures.
In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). ASU 2016-02 amends existing leasing accounting
requirements. The most significant change will result in the recognition of lease assets and lease liabilities by lessees for virtually all
leases. The new guidance will also require significant additional disclosures about the amount, timing and uncertainty of cash flows
from leases. ASU 2016-02 is effective for fiscal years and interim periods beginning after December 15, 2018. Upon adoption, entities
are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach.
Early adoption is permitted, and a number of optional practical expedients may be elected to simplify the impact of adoption. The
Company is assessing ASU 2016-02 and the impact that adopting this new accounting standard will have on its consolidated financial
statements and footnote disclosures.
In March 2016, the FASB issued ASU No. 2016-09, Compensation (Topic 718) Stock Compensation. ASU 2016-09 identifies
areas for simplification involving several aspects of accounting for share-based payment transactions, including the income tax
consequences, classification of awards as equity or liabilities, an option to recognize gross stock compensation expense with actual
forfeitures recognized as they occur, as well as certain classifications on the statement of cash flows. ASU 2016-09 is effective as of
January 1, 2017. The Company is assessing ASU 2016-09 and the impact that adopting this new accounting standard will have on its
consolidated financial statements and footnote disclosures.
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments (Topic 326) Credit Losses. ASU 2016-13 changes the
impairment model for most financial assets and certain other instruments. Under the new standard, entities holding financial assets and
net investment in leases that are not accounted for at fair value through net income are to be presented at the net amount expected to be
collected. An allowance for credit losses will be a valuation account that will be deducted from the amortized cost basis of the financial
asset to present the net carrying value at the amount expected to be collected on the financial asset. ASU 2016-13 is effective as of
January 1, 2020. Early adoption is permitted. The adoption of this standard is not expected to have a material impact on the Company’s
consolidated financial statements or footnote disclosures.
Recently Adopted
In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a
Going Concern. ASU 2014-15 defines management’s responsibility to assess an entity’s ability to continue as a going concern at each
annual and interim reporting period, and requires additional disclosures in certain circumstances. This guidance is effective for the
annual period ending after December 15, 2016, and for annual and interim periods thereafter. The Company adopted the new standard in
the fourth quarter and performed the required assessment. The adoption of this standard did not have an impact on the Company’s
disclosures. The Company believe that we have adequate financial resources to support our business for at least the twelve months from
the issuance date of our financial statements.
In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330) Simplifying the Measurement of Inventory. ASU
2015-11 more closely aligns the measurement of inventory in US GAAP with the measurement of inventory in International Financial
Reporting Standards by requiring companies using the first-in, first-out and average costs methods to measure inventory using the lower
of standard cost and net realizable value, where net realizable value is the estimated selling prices in the ordinary course of business less
reasonably predictable costs of completion, disposal, and transportation. The provisions of ASU 2015-11 are effective for annual and
interim periods beginning after December 15, 2016. ASU 2015-11 should be applied prospectively with earlier application permitted as
of the beginning of an interim or annual reporting period. The Company adopted this standard for the interim reporting period ended
March 31, 2016. The adoption of this standard did not have a material impact on the Company’s financial position or results of
operations.
- 52 -
3. Investments
All of the Company’s investments are classified as available-for-sale and are carried at fair value with unrealized gains and
losses recorded as a component of accumulated other comprehensive income, net of related income taxes. The Company held bank
certificates of deposits of $20.5 million and $25.8 million at December 31, 2016 and 2015, respectively. The Company also held
corporate debt securities of $2.0 million at December 31, 2015. There were no unrealized gains or losses on the Company’s available-
for-sale securities at December 31, 2016 or 2015.
4. Fair Value Measurements
The Company’s investments are all classified within Level 2 of the fair value hierarchy. The Company’s investments classified
within Level 2 of the fair value hierarchy are valued based on matrix pricing compiled by third party pricing vendors, using observable
market inputs such as interest rates, yield curves, and credit risk.
The fair value hierarchy of the Company’s cash equivalents and investments at fair value is as follows:
Fair Value Measurements at Reporting
Date Using
Quoted Prices in
Active Markets
for Identical Assets
(Level 1)
Significant Other
Observable Inputs
(Level 2)
Significant
Unobservable Inputs
(Level 3)
December 31, 2016
$
68,352 $
750
69,102
- $
-
-
68,352 $
750
69,102
$
20,500 $
- $
20,500 $
-
-
-
-
Fair Value Measurements at Reporting
Date Using
Quoted Prices in
Active Markets
for Identical Assets
(Level 1)
Significant Other
Observable Inputs
(Level 2)
Significant
Unobservable Inputs
(Level 3)
December 31, 2015
$
$
$
$
61,385 $
250
61,635 $
2,001 $
25,750
27,751 $
- $
-
- $
- $
-
- $
61,385 $
250
61,635 $
2,001 $
25,750
27,751 $
-
-
-
-
-
-
Cash equivalents:
Money market funds
Bank certificates of deposit
Total cash equivalents
Investments:
Bank certificates of deposit
Cash equivalents:
Money market funds
Bank certificates of deposit
Total cash equivalents
Investments:
Corporate debt securities
Bank certificates of deposit
Total investments
The Company did not have any transfers between Level 1 and Level 2 or transfers in or out of Level 3 of the fair value
hierarchy during the years ended December 31, 2016 and 2015.
- 53 -
5. Earnings per Share (“EPS”)
Basic EPS is calculated by dividing net income by the weighted average number of shares outstanding during the period.
Unvested RSA’s, although legally issued and outstanding, are not considered outstanding for purposes of calculating basic earnings per
share. Diluted EPS is calculated by dividing net income by the weighted average number of shares outstanding plus the dilutive effect, if
any, of outstanding stock options, stock appreciation rights (“SARs”), RSA’s, and RSU’s using the treasury stock method.
The following table provides share information used in the calculation of the Company's basic and diluted earnings per share:
Shares used in the calculation of basic earnings per share
Effect of dilutive securities:
Stock options, SAR's, RSA's and RSU's
Diluted shares used in the calculation of earnings per share
Years Ended December 31,
2015
2016
2014
14,682
14,934
434
15,116
387
15,321
14,678
591
15,269
Stock options to purchase 0.4 million shares, 0.2 million shares, and 0.1 million shares for the years ended December 31, 2016,
2015, and 2014, respectively, were excluded from the computation of diluted EPS as their effect would have been anti-dilutive.
At December 31, 2016, 2015, and 2014, 0.1 million shares, 0.1 million shares, and 30 thousand shares of issued and
outstanding unvested RSA’s, respectively, were excluded from the basic earnings per share.
On February 26, 2016, the Company entered into an accelerated stock repurchase agreement with Morgan Stanley & Co. LLC
(“Morgan Stanley”) pursuant to a Fixed Dollar Accelerated Share Repurchase Transaction (“ASR Agreement") to purchase $25.0
million of shares of its common stock. Pursuant to the terms of the ASR Agreement, the Company paid Morgan Stanley $25.0 million in
cash and received an initial delivery of 0.4 million shares of the Company’s common stock on February 29, 2016 based on a closing
market price of $46.40 per share and the applicable contractual discount.
On August 26, 2016, the Company settled the approximately $7.5 million remaining under the ASR Agreement, which was
recorded as an equity forward sale contract and was included in additional paid-in capital in stockholders' equity in the condensed
consolidated balance sheet as it met the criteria for equity accounting. Pursuant to the terms of the ASR Agreement, the final number of
shares and the average purchase price was determined at the end of the applicable purchase period, which was August 26, 2016. Based
on the volume-weighted average price since the effective date of the ASR Agreement less the applicable contractual discount, Morgan
Stanley delivered 0.1 million additional shares to the Company on August 31, 2016. In total, 0.5 million shares were repurchased under
the ASR Agreement at an average repurchase price of $47.08 per share. These shares are held by the Company as authorized but
unissued shares pursuant to Massachusetts law. The initial and final delivery of shares resulted in immediate reductions of the
outstanding shares used to calculate the weighted-average common shares outstanding for basic and diluted net income per share.
6. Inventories
Inventories consist of the following:
Raw materials
Work-in-process
Finished goods
Total
December 31,
2016
2015
5,884 $
5,559
4,540
15,983 $
5,780
5,656
3,502
14,938
$
$
- 54 -
7. Property and Equipment
Property and equipment is stated at cost and consists of the following:
Equipment and software
Furniture and fixtures
Leasehold improvements
Construction in progress
Subtotal
Less accumulated depreciation
Total
December 31,
2016
2015
27,456 $
1,126
27,796
22,695
79,073
(26,777)
52,296 $
24,512
1,240
27,622
11,274
64,648
(24,540)
40,108
$
$
The Construction in progress asset as of December 31, 2016 increased in comparison to December 31, 2015 primarily as a
result of increased capital purchases associated with the Company’s Bedford, Massachusetts headquarters and manufacturing
facility. This is part of the Company’s on-going project to establish additional manufacturing capabilities at the Bedford, Massachusetts
facility to manufacture our HYAFF-based products, which were previously manufactured by a third party in Italy. The Construction in
progress asset will be depreciated once it goes into production.
Depreciation expense was $2.7 million, $2.7 million, and $2.6 million for the years ended December 31, 2016, 2015, and 2014,
respectively.
8. Acquired Intangible Assets, Net
In November 2007, in connection with the termination of the agreement with Galderma which originally granted to Galderma
the worldwide rights to commercialize, distribute, and market the ELEVESS product, the Company reacquired the worldwide rights and
control of the future development and marketing of ELEVESS. The intangible asset realized during this process was the ELEVESS trade
name which is fully amortized as of December 31, 2016.
On December 30, 2009, in connection with the acquisition of Anika S.r.l., the Company purchased various intangible
assets. The Company finalized the purchase price allocation relative to this acquisition during the fourth quarter of 2010.
In January 2015, the Company received CE Mark approval for HYALOSPINE which is an innovative adhesion prevention gel
for use after spinal surgery, and was a component of the IPR&D intangible assets initially identified. As a result of this approval the
Company has reclassified $0.4 million from IPR&D to developed technology and began amortization on the HYALOSPINE asset.
In 2015, the Company recorded an impairment charge totaling $0.7 million to write-off in-process research and development
that was recorded in connection with its acquisition of Anika S.r.l. Subsequent to an evaluation in the fourth quarter of the ongoing
research and development efforts surrounding the Hemostatic Patch IPR&D project, the Company determined it would discontinue
further development efforts needed to commercialize this technology. As a result of this decision, an impairment charge was recorded.
These amounts are included in research and development expenses on our consolidated statements of operations.
The Company performed an annual assessment of IPR&D intangible assets as of November 30, 2016. Based upon that
assessment, for the fiscal year 2016 there were no events or changes in circumstances that would result in a change in the carrying value
of IPR&D.
Total amortization expense was $1.1 million, $1.1 million, and $2.1 million for the years ended December 31, 2016, 2015, and
2014, respectively. Amortization expense on intangible assets is expected to be approximately $0.9 million in 2017, $0.9 million
annually through 2021, and approximately $2.8 million in aggregate thereafter.
- 55 -
Intangible assets consist of the following:
Developed technology
In-process research & development
Distributor relationships
Patents
Elevess trade name
Total
9. Goodwill
December 31, 2016
December 31, 2015
Accumulated
Currency Translation
Adjustment
Accumulated
Amortization
Net Book
Value
Net Book
Value
(3,442) $
(1,433)
(415)
(207)
-
(5,497) $
Useful Life
15
7,959
3,099 Indefinite
(6,816) $
-
6,842 $
2,973
-
412
-
(4,285)
(381)
(1,000)
-
473
125
(12,482) $ 10,227 $ 11,656
5
16
9
Gross Value
$
17,100 $
4,406
4,700
1,000
1,000
28,206 $
$
The Company completed its annual impairment review as of November 30, 2016 and concluded that no impairment in the
carrying value exists as of that date with respect to goodwill. Through December 31, 2016, there have not been any events or changes in
circumstances that indicate that the carrying value of goodwill may not be recoverable. Changes in the carrying value of goodwill were
as follows:
Balance, beginning
Effect of foreign currency adjustments
Balance, ending
$
$
7,482 $
(268)
7,214 $
8,339
(857)
7,482
December 31,
2016
2015
10. Accrued Expenses
Accrued expenses consist of the following:
Compensation and related expenses
Facility construction costs
Research grants
Clinical trial costs
Professional fees
Deferred Rent
Other
Total
December 31,
2016
2015
3,089 $
804
463
227
802
231
880
6,496 $
3,082
415
381
252
210
-
438
4,778
$
$
- 56 -
11. Commitments and Contingencies
Leasing Arrangements
The Company’s headquarters facility is located in Bedford, Massachusetts, where the Company leases approximately 134,000
square feet of administrative, manufacturing, and R&D space. This lease was entered into on January 4, 2007, and the lease commenced
on May 1, 2007 for an initial term of ten and one-half years. On February 2, 2017, the Company finalized the exercise of its first option
under the lease to extend the terms from November 1, 2017 through October 31, 2022, including the determination of a new annual base
rent of $1.5 million which is included in the future lease commitments table below. No other terms of the Lease were altered. The
Company has an option under the lease to extend its terms for up to three additional periods subject to the condition that the Company
notify the landlord that the Company is exercising each option at least one year prior to the expiration of the original or then current
term. The next two renewal options each extend the term an additional five years, while the final renewal option extends the term by six
years. The Company’s administrative and R&D personnel moved into the Bedford facility in November of 2007. The Bedford facility
was fully validated and approved by applicable regulatory authorities in 2012.
On October 9, 2015, Anika S.r.l, entered into a build-to-suit lease agreement with Consorzio Zona Industriale E Porto Fluviale
di Padova (“ZIP”), as landlord, pursuant to which Anika S.r.l. will lease a new European headquarters facility, consisting of
approximately 33,000 square feet of general office, research and development, training, and warehousing space located in Padova, Italy.
The Lease has an initial term of fifteen years, which is expected to commence during the first quarter of 2017 once construction of the
facility is completed. The Lease will automatically renew for up to three additional six-year terms, subject to certain terms and
conditions. The Company has the ability to withdraw from this lease subject to certain financial penalties after six years and with no
penalties after the ninth year. Beginning on the commencement date, the Lease provides for an initial yearly rent of approximately $0.3
million.
Construction of the new facility began in the first quarter of 2016 and is expected to be completed in early 2017. During the
period of construction, the Company is considered the deemed owner of the facility and as a result at December 31, 2016 has recorded a
construction-in-process asset of approximately $1.7 million, and an offsetting facility lease obligation associated with the new facility.
Anika S.r.l. leases approximately 28,000 square feet of laboratory, warehouse, and office space in Abano Terme, Italy. On
December 29, 2016 Anika S.r.l. notified the landlord of its intention to terminate the lease agreement originally executed on December
30, 2009 for the facility that serves as the current headquarters for Anika S.r.l. as of March 31, 2017.
Rental expense in connection with the various facility leases totaled $1.3 million, $1.3 million and $1.4 million for the year
ended December 31, 2016, 2015 and 2014, respectively.
The Company’s future lease commitments as of December 31, 2016 are as follows:
2017
2018
2019
2020
2021 and thereafter
Total
Warranty and Guarantor Arrangements
$
$
1,454
1,878
1,858
1,888
4,759
11,837
In certain of its contracts, the Company warrants to its customers that the products it manufactures conform to the product
specifications as in effect at the time of delivery of the specific product. The Company may also warrant that the products it
manufactures do not infringe, violate or breach any U.S. patent or intellectual property rights, trade secret, or other proprietary
information of any third party. On occasion, the Company contractually indemnifies its customers against any and all losses arising out
of, or in any way connected with, any claim or claims of breach of its warranties or any actual or alleged defect in any product caused by
the negligence or acts or omissions of the Company. The Company maintains a products liability insurance policy that limits its
exposure to these risks. Based on the Company’s historical activity, in combination with its liability insurance coverage, the Company
believes the estimated fair value of these indemnification agreements is immaterial. The Company has no accrued warranties at
December 31, 2016 or 2015, respectively, and has no history of claims paid.
- 57 -
Legal Proceedings
On July 7, 2010, Genzyme Corporation filed a complaint against the Company in the United States District Court for the
District of Massachusetts seeking unspecified damages and equitable relief. The complaint alleged that the Company infringed U.S.
Patent No. 5,143,724 by manufacturing MONOVISC in the United States for sale outside the United States and would infringe U.S.
Patent Nos. 5,143,724 and 5,399,351 if the Company manufactured and sold MONOVISC in the United States. On March 7, 2014,
Genzyme and the Company filed a joint motion to lift the stay in Genzyme’s lawsuit against the Company and to dismiss with prejudice
all of Genzyme’s claims. On March 10, 2014, the District Court granted the motion to dismiss all of Genzyme’s claims against the
Company with prejudice, and the case was terminated.
The Company is involved in various other legal proceedings arising in the normal course of business. Although the outcomes of
these other legal proceedings are inherently difficult to predict, the Company does not expect the resolution of these other legal
proceedings to have a material adverse effect on its financial position, results of operations, or cash flow.
12. Equity Incentive Plan
The Anika Therapeutics, Inc. Stock Option and Incentive Plan, as amended, (the “2003 Plan”) provides for grants of
nonqualified and incentive stock options, common stock, restricted stock, restricted stock units, and SAR’s to employees, directors,
officers, and consultants. The 2003 Plan was originally approved by the Board of Directors on April 4, 2003, approved by the
Company’s shareholders on June 4, 2003, and reserved 1,500,000 shares of common stock for grant pursuant to its terms.
On May 29, 2009, the Board of Directors approved changes to the 2003 Plan and adopted the Amended and Restated 2003
Stock Option and Incentive Plan (the “Amended 2003 Plan”) to increase the number of shares available to grant by 850,000. The
Amended 2003 Plan was approved by the Company’s shareholders on June 5, 2009, and it resulted in a total of 2,350,000 shares of
common stock being reserved for issuance under the Amended 2003 Plan.
At the 2011 Annual Meeting of Stockholders on June 7, 2011, the shareholders of the Company approved the Anika
Therapeutics, Inc. Second Amended and Restated Stock Option and Incentive Plan (the “2003 Plan”), which, among other things,
increased the number of shares reserved for issuance under the Company’s predecessor stock option and incentive plan by 800,000 to
3,150,000 shares. Pursuant to this amendment and restatement to the 2003 Plan approved by the Company’s shareholders, each share
award issued after June 7, 2011 other than stock options or stock appreciation rights will reduce the number of total shares available for
grant by 1.9 shares.
At the 2013 Annual Meeting of Stockholders on June 18, 2013, the shareholders of the Company approved an additional
amendment to the Amended 2003 Plan, which, among other things, increased the number of shares reserved for issuance under the
Company’s stock option and incentive plan by 650,000 to 3,800,000 shares. Pursuant to this amendment and restatement to the 2003
Plan approved by the Company’s shareholders, each share award issued after June 18, 2013 other than stock options or stock
appreciation rights will reduce the number of total shares available for grant by 1.5 shares. There are 0.9 million shares available for
future grant at December 31, 2016.
The Company may satisfy the awards upon exercise, or upon fulfillment of the vesting requirements for other equity-based
awards, with either newly-issued shares or shares reacquired by the Company. Stock-based awards are granted with an exercise price
equal to the market price of the Company’s stock on the date of grant. Awards contain service conditions or service and performance
conditions, and they generally become exercisable ratably over one to four years.
The Company estimates the fair value of stock options and SAR’s using the Black-Scholes valuation model. Fair value of
restricted stock is measured by the grant-date price of the Company’s shares. Key input assumptions used to estimate the fair value of
stock options and SAR’s include the exercise price of the award, the expected award term, the expected volatility of the Company’s
stock over the option’s expected term, the risk-free interest rate over the award’s expected term, and the Company’s expected annual
dividend yield.
The Company uses historical data on the exercise of stock options and other factors to evaluate and estimate the expected term
of share-based awards. The Company also evaluates actual forfeiture rates periodically and adjusts the expected forfeiture rate
assumption within the model accordingly. The expected volatility assumption is evaluated against the historical volatility of the
Company’s common stock over a four-year average, and it is adjusted if there are material swings in historical volatility. The risk-free
interest rate assumption is based on U.S. Treasury interest rates at the time of grant.
- 58 -
The fair value of each stock option during 2016, 2015, and 2014 was estimated on the grant date using the Black-Scholes
option-pricing model with the following assumptions:
2016
December 31,
2015
2014
Risk free interest rate
Expected volatility
Expected life (years)
Expected dividend yield
0.94% - 1.55% 1.15% - 1.46% 1.16% - 1.39%
47.33% - 51.61% 53.15% - 54.65% 53.28% - 57.05%
4.5
0.00%
4.5
0.00%
4.0
0.00%
The Company recorded $3.4 million, $2.2 million, and $1.6 million of stock-based compensation expense for the years ended
December 31, 2016, 2015, and 2014, respectively, for stock options, SAR’s, RSA’s and RSU’s. The Company presents the expenses
related to stock-based compensation awards in the same expense line items as cash compensation paid to each of its employees as
follows:
Cost of product revenue
Research & development
Selling, general & administrative
Total stock-based compensation expense
2016
December 31,
2015
148 $
467
2,777
3,392 $
42 $
269
1,914
2,225 $
$
$
2014
61
202
1,344
1,607
Combined stock options and SAR’s activity under the Company’s plans is summarized as follows for the years ended
December 31, 2016 and 2015, respectively:
Options and SAR's outstanding at beginning of year
Granted
Cancelled
Expired
Exercised
Stock options and SAR's outstanding at end of year
2016
2015
Weighted
Average
Exercise
Price Per
Share
Weighted
Average
Exercise
Price Per
Share
Number of
Shares
18.75
40.77
30.05
11.37
15.46
26.15
851,287 $
111,625 $
(85,349) $
(8,825) $
(106,478) $
762,260 $
14.85
39.25
19.77
20.03
10.96
18.75
Number of
Shares
762,260 $
354,275 $
(58,841) $
(3,310) $
(74,815) $
979,569 $
Of the 979,569 stock options and SAR’s outstanding at December 31, 2016, 903,076 are vested or are expected to vest, with a
weighted-average exercise price of approximately $24.92 as well as an aggregate intrinsic value of approximately $21.7 million related
to these awards. The weighted average remaining contractual term of the vested and expected to vest stock options and SAR’s was 6.8
years as of December 31, 2016.
As of December 31, 2016, total unrecognized compensation costs related to non-vested stock options and SAR’s was
approximately $5.0 million and is expected to be recognized over a weighted average period of 2.8 years.
There were 144,316 incentive stock options exercisable at December 31, 2016 with a weighted-average exercise price of $10.22
and a weighted-average remaining contractual term of 4.7 years for these awards.
There were 281,093 non-qualified stock options exercisable at December 31, 2016 with a weighted-average exercise price of
$15.61 and a weighted-average remaining contractual term of 5.7 years.
There were 7,065 performance awards exercisable at December 31, 2016 with a weighted-average exercise price of $39.69 and
a weighted-average remaining contractual term of 8.1 years for these awards.
There were 40,250 SAR’s exercisable at December 31, 2016 with a weighted-average exercise price of $6.94 and a weighted-
average remaining contractual term of 2.8 years for these awards.
- 59 -
The aggregate intrinsic value of stock options and SAR’s fully vested at December 31, 2016 and 2015 was $16.7 million and
$11.6 million, respectively. The aggregate intrinsic value of stock options and SAR’s outstanding at December 31, 2016 and 2015 was
$22.3 million and $15.2 million, respectively.
The total intrinsic value of stock options and SAR’s exercised was $2.1 million and $3.1 million for the years ended
December 31, 2016 and 2015, respectively.
The total fair value of stock options and SAR’s vested during the years ended December 31, 2016 and 2015 was approximately
$1.3 and $1.1 million, respectively.
The Company received $1.0 million and $1.1 million for exercises of stock options during the years ended December 31, 2016
and 2015, respectively.
The RSA and RSU activity for the years ended December 31, 2016 and 2015 is as follows:
2016
2015
Weighted
Average
Grant Date
Fair Value
Number of
Shares
Number of
Shares
Nonvested at Beginning of year
Granted
Cancelled
Expired
Vested/Released
Nonvested at end of year
150,384 $
87,158 $
(4,950) $
- $
(25,515) $
207,077 $
34.29
38.11
36.20
-
33.35
36.44
109,614 $
81,080 $
(10,635) $
- $
(29,675) $
150,384 $
Weighted
Average
Grant Date
Fair Value
23.91
37.84
32.02
-
19.31
34.29
The total fair value of RSA’s and RSU’s vested during the years ended December 31, 2016 and 2015 was $1.0 million and $1.2
million.
13. Shareholder Rights Plan
On April 4, 2008, the Board of Directors of the Company adopted a Shareholder Rights Plan (the “2008 Plan”) that replaced the
Company’s former Shareholder Rights Plan. Under the 2008 Plan, the Rights generally become exercisable if:
(1) A person becomes an “Acquiring Person” by acquiring 15% or more of the Company’s common stock, or
(2) A person commences a tender offer that would result in that person owning 15% or more of the Company’s common stock.
In the event that a person becomes an “Acquiring Person,” each holder of a Right (other than the Acquiring Person) would be
entitled to acquire a number of shares of preferred stock equivalent to shares of the Company’s common stock having a value of twice
the exercise price of the Right. If, after any such event, the Company enters into a merger or other business combination transaction with
another entity, each holder of a Right would then be entitled to purchase, at the then-current exercise price, shares of the acquiring
company’s common stock having a value of twice the exercise price of the Right.
The current exercise price per Right is $75.00. The Rights may be redeemed in whole, but not in part, at a price of $0.01 per
Right (payable in cash, shares of the Company’s common stock, or other consideration deemed appropriate by the Board of Directors)
by the Board of Directors only until the earlier of:
(1) The time at which any person becomes an “Acquiring Person,” or
(2) The Expiration Date.
At any time after any person becomes an “Acquiring Person,” the Board of Directors may, at its option, exchange all or any
part of the then outstanding and exercisable Rights for shares of the Company’s common stock at an exchange ratio specified in the
2008 Plan. Notwithstanding the foregoing, the Board of Directors generally will not be empowered to affect such exchange at any time
after any person becomes the beneficial owner of 50% or more of the Company’s common stock.
In connection with the establishment of the 2008 Plan, the Board of Directors approved the creation of Preferred Stock of the
Company designated as Series B Junior Participating Cumulative Preferred Stock with a par value of $0.01 per share. The Board also
reserved 175,000 shares of preferred stock for issuance upon exercise of the Rights. Until a Right is exercised, the holder will have no
rights as a stockholder of the Company, beyond those as an existing stockholder, including the right to vote or to receive dividends.
- 60 -
14. Employee Benefit Plan
U.S. employees are eligible to participate in the Company’s 401(k) savings plan. Employees may elect to contribute a
percentage of their compensation to the plan, and the Company will make 140% matching contributions up to a limit of 5% of an
employee’s eligible compensation. In addition, the Company may make annual discretionary contributions. The Company made
matching contributions of $0.6 million , $0.4 million, and $0.4 million for the years ended December 31, 2016, 2015, and 2014,
respectively.
15. Revenue by Product Group, by Significant Customer and by Geographic Location; Geographic Information
Product revenue by product group is as follows:
2016
Years Ended December 31,
2015
2014
Orthobiologics
Dermal
Surgical
Other
Revenue
89,695
$
2,759
5,427
5,051
$ 102,932
Percentage
of Product
Revenue
Revenue
73,247
2,266
5,812
6,371
87,696
87% $
3%
5%
5%
100% $
Percentage
of Product
Revenue
Revenue
61,957
1,334
5,855
6,328
75,474
84% $
2%
7%
7%
100% $
Percentage
of Product
Revenue
82%
2%
8%
8%
100%
Product revenue from our sole significant customer, Mitek, as a percentage of our total product revenue was 75%, 72%, and
72% for the years ended December 31, 2016, 2015, and 2014, respectively.
In December 2011, the Company entered into a fifteen-year licensing agreement (the “Mitek MONOVISC Agreement”) with
DePuy Synthes Mitek Sports Medicine, a division of DePuy Orthopaedics, Inc., to exclusively market MONOVISC in the U.S. The
Company received an upfront payment of $2.5 million in December 2011. This non-refundable upfront payment did not have standalone
value without Anika’s completion of development obligations, which included obtaining regulatory approval of the product and
resolving the related patent litigation. As a result, the Company recognized the upfront payment over the development obligation period.
During the first quarter of 2014, the Company received FDA approval of MONOVISC and resolved the patent lawsuit with Genzyme
Corporation. As a result of the full delivery of its development obligations under this agreement, the Company recognized
approximately $2.2 million, which represented the remaining balance of deferred revenue relating to the initial $2.5 million payment. In
the first quarter of 2014, the Company also received a milestone payment of $17.5 million as a result of achieving FDA approval for
MONOVISC and resolving the patent litigation with Genzyme. This milestone payment was fully recognized as revenue during the
three months ended March 31, 2014. On April 15, 2014 the first U.S. commercial sale of MONOVISC was made by the Company’s
commercial partner, Mitek. Under the terms of the Mitek MONOVISC Agreement, the Company earned and collected a milestone
payment of $5 million, which was fully recognized as revenue in the second quarter of 2014. On November 10, 2014, the Center for
Medicare & Medicaid Services ("CMS") assigned a unique Healthcare Common Procedure Coding System ("HCPCS") code, or J-Code,
to MONOVISC. The issuance of this code by CMS set national Medicare reimbursement rates for the product. The new J-Code became
effective on January 1, 2015. As a result of CMS assigning the J-Code, the Company collected a milestone payment of $5.0 million,
which was fully recognized as revenue in the fourth quarter of 2014. During the fourth quarter of 2015, the Company collected and fully
recognized revenue for a milestone payment of $5.0 million as a result of U.S. MONOVISC 12 month rolling end-user sales exceeding
$50 million. For the year ended December 31, 2015, the Company recognized a total of $5.0 million in milestone revenue related to
MONOVISC. The Company did not recognize any milestone revenue associated with this contract for the year ended December 31,
2016.
Total revenue by geographic location based on the location of the customer in total and as a percentage of total revenue are as
follows:
Geographic Location:
United States
Europe
Other
Total
Total
Revenue
2016
Percentage of
Revenue
Years Ended December 31,
2015
Percentage of
Revenue
Total
Revenue
Total
Revenue
2014
Percentage of
Revenue
$ 83,972
10,953
8,454
$ 103,379
81% $ 76,621
8,756
11%
7,622
8%
100% $ 92,999
82 % $ 92,259
6,215
7,121
100 % $ 105,595
9 %
9 %
87%
6%
7%
100%
- 61 -
The Company recorded licensing, milestone, and contract revenue of $0.4 million, $5.3 million and $30.1 million for the years
ended December 31, 2016, 2015, and 2014, respectively. Substantially all licensing, milestone, and contract revenue was derived in the
United States for each year presented.
Net long-lived assets, consisting of net property and equipment, are subject to geographic risks because they are generally
difficult to move and to effectively utilize in another geographic area in a reasonable time period and because they are relatively illiquid.
See Note 11, Commitments and Contingencies, for more information regarding the build-to-suit lease agreement with Zip resulting in an
increase in net property and equipment in Italy. Net tangible long-lived assets by principal geographic areas are as follows:
United States
Italy
Total
Years Ended December 31,
2016
2015
$
$
49,140 $
3,156
52,296 $
39,732
376
40,108
16. Income Taxes
Income Tax Expense
The components of the Company’s income before income taxes and its provision for (benefit from) income taxes consist of the
following:
Income before income taxes
Domestic
Foreign
Provision for (benefit from) income taxes:
Current provision:
Federal
State
Foreign
Deferred provision:
Federal
State
Foreign
Total provision
Years ended December 31,
2015
2016
2014
50,181 $
689
50,870 $
48,608 $
(354)
48,254 $
63,232
(1,727)
61,505
Years ended December 31,
2015
2016
2014
14,982 $
3,265
302
18,549
(70)
(84)
(72)
(226)
18,323 $
14,572 $
3,635
249
18,456
(370)
(33)
(557)
(960)
17,496 $
18,301
3,895
192
22,388
1,153
122
(477)
798
23,186
$
$
$
$
- 62 -
Deferred Tax Assets and Liabilities
Significant components of the Company’s deferred tax assets and liabilities consist of the following:
Deferred tax assets:
Net operating loss carry forward, foreign
Stock-based compensation expense
Foreign currency exchange
Accrued expenses and other
Inventory reserve
Deferred tax assets
Deferred tax liabilities:
Acquisition-related Intangibles
Depreciation
Deferred tax liabilities
Net deferred tax liabilities
Tax Rate
December 31,
2016
2015
1,253 $
1,882
677
308
640
4,760 $
1,567
1,043
762
510
547
4,429
December 31,
2016
2015
(2,932) $
(8,376)
(11,308) $
(3,738)
(7,466)
(11,204)
(6,548) $
(6,775)
$
$
$
$
$
The reconciliation between the U.S. federal statutory rate and the Company’s effective rate is summarized as follows:
Statutory federal income tax rate
State tax expense, net of federal benefit
Permanent items, including nondeductible expenses
State investment tax credit
Federal, state and foreign research and development credits
Foreign rate differential
Domestic production deduction
Effective income tax rate
Years ended December 31,
2015
35.0%
4.8%
(0.3%)
0.0%
(0.4%)
0.1%
(2.9%)
36.3%
2016
35.0%
4.5%
0.5%
(0.1%)
(0.9%)
(0.1%)
(2.9%)
36.0%
2014
35.0%
4.9%
0.1%
(0.1%)
(0.7%)
0.2%
(1.7%)
37.7%
As of December 31, 2016, the Company had NOL’s for income tax purposes in Italy of $5.2 million that do not expire.
Accounting for Uncertainty in Income Taxes
The Company had no unrecognized tax benefits for the years ended December 31, 2016 and 2015, respectively.
In the normal course of business, Anika and its subsidiaries may be periodically examined by various taxing authorities. The
Company files income tax returns in the United States on a federal basis, in certain U.S. states, and in Italy. The associated tax filings
remain subject to examination by applicable tax authorities for a certain length of time following the tax year to which those filings
relate. Substantially all of the Company’s filings from 2013 through the present tax year remain subject to examination by the Internal
Revenue Service (“IRS”) and other taxing authorities for U.S. federal and state tax purposes. The Company’s 2014 tax filing has been
audited by the IRS and closed. The Company currently has a tax audit in progress in Italy which it does not anticipate will have a
material impact on its financial statements. The Company’s filings from 2010 through the present tax year remain subject to
examination by the appropriate governmental authorities in Italy.
- 63 -
The Company does not anticipate experiencing any significant increases or decreases in its unrecognized tax benefits within
the twelve months following December 31, 2016.
The Company incurred expenses related to stock-based compensation in 2016, 2015, and 2014 of $3.4 million, $2.2 million,
and $1.6 million, respectively. Accounting for the tax effects of certain stock-based awards requires that the Company establish a
deferred tax asset as the compensation expense is recognized for financial reporting prior to recognizing the related tax deduction upon
exercise of the awards. The gross tax benefit recognized in the consolidated statement of operations related to stock-based compensation
totaled $1.2 million, $1.1 million, and $3.1 million in 2016, 2015, and 2014, respectively.
Upon the settlement of certain stock-based awards (i.e., exercise, vesting, forfeiture, or cancellation), the actual tax deduction is
compared with cumulative financial reporting compensation cost, and any excess tax deduction related to these awards is considered a
windfall tax benefit. Such benefits are tracked in a “windfall tax benefit pool” to offset any future tax deduction shortfalls, and they will
be recorded as increases to additional paid-in capital in the period when the tax deduction reduces income taxes payable. The Company
follows the with-and-without approach for the direct effects of windfall/shortfall items and to determine the timing of the recognition of
any related benefits. The Company recorded a net windfall of $0.6 million, $0.9 million, and $9.6 million in 2016, 2015, and 2014,
respectively.
17. Quarterly Financial Data (Unaudited)
Year 2016
Product revenue
Total revenue
Cost of product revenue
Gross profit on product revenue
Net income
Per common share information:
Basic net income per share
Basic common shares outstanding
Diluted net income per share
Diluted common shares outstanding
Year 2015
Product revenue
Total revenue
Cost of product revenue
Gross profit on product revenue
Net income
Per common share information:
Basic net income per share
Basic common shares outstanding
Diluted net income per share
Diluted common shares outstanding
Quarter ended
December 31
Quarter ended
September 30
Quarter ended
June 30
Quarter ended
March 31
$
$
$
$
28,296 $
28,726
7,539
20,757
8,085 $
0.56 $
14,538
0.54 $
14,979
25,783 $
25,789
4,998
20,785
8,952 $
0.61 $
14,625
0.59 $
15,077
26,575 $
26,581
6,065
20,510
8,615 $
0.59 $
14,679
0.57 $
15,111
22,278
22,283
5,425
16,853
6,895
0.46
14,875
0.45
15,307
Quarter ended
December 31
Quarter ended
September 30
Quarter ended
June 30
Quarter ended
March 31
$
$
$
$
25,607 $
30,894
6,290
19,317
11,042 $
0.74 $
14,965
0.72 $
15,353
23,676 $
23,681
5,176
18,500
8,380 $
0.56 $
14,967
0.55 $
15,316
22,898 $
22,904
5,274
17,624
7,820 $
0.52 $
14,961
0.51 $
15,336
15,515
15,520
4,313
11,202
3,516
0.24
14,905
0.23
15,330
- 64 -
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
(a)
Evaluation of disclosure controls and procedures.
As required by Rule 13a-15 under the Securities Exchange Act of 1934 (“Exchange Act”), we carried out an evaluation under
the supervision and with the participation of our management, including our chief executive officer and chief financial officer, of the
effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this report.
Based upon that evaluation, the chief executive officer and chief financial officer have concluded that our disclosure controls and
procedures are effective as of December 31, 2016 to ensure that information required to be disclosed by us in reports we file or submit
under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms.
Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to
be disclosed by our company in the reports we file or submit under the Exchange Act is accumulated and communicated to our
management, including our chief executive officer and chief financial officer, or persons performing similar functions, as appropriate to
allow timely decisions regarding required disclosure. On an on-going basis, we review and document our disclosure controls and
procedures, and our internal control over financial reporting, and we may from time to time make changes aimed at enhancing their
effectiveness and ensuring that our systems evolve with our business.
(b)
Changes in internal controls over financial reporting.
There were no changes in our internal control over financial reporting during the fourth quarter of fiscal year 2016 that have
materially affected, or that are reasonably likely to materially affect, our internal controls over financial reporting.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in
Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Our 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 in the United States.
Because of its inherent limitations, internal control over financial reporting can provide only reasonable assurance, and it 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.
Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2016. In making
this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in
its 2013 Internal Control—Integrated Framework.
Based on its assessment and those criteria, our management believes that our company maintained effective internal control
over financial reporting as of December 31, 2016.
The effectiveness of our internal control over financial reporting as of December 31, 2016 has been audited by
PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which is included elsewhere in
this Annual Report on Form 10-K.
ITEM 9B. OTHER INFORMATION
None.
- 65 -
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to
Regulation 14A, which proxy statement will be filed with the SEC not later than 120 days after the close of our fiscal year ended
December 31, 2016.
ITEM 11. EXECUTIVE COMPENSATION
The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to
Regulation 14A, which proxy statement will be filed with the SEC not later than 120 days after the close of our fiscal year ended
December 31, 2016.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS
The information required under this item and Item 5 of this Annual Report on Form 10-K under the heading “Equity
Compensation Plan Information” is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A,
which proxy statement will be filed with the SEC not later than 120 days after the close of our fiscal year ended December 31, 2016.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to
Regulation 14A, which proxy statement will be filed with the SEC not later than 120 days after the close of our fiscal year ended
December 31, 2016.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to
Regulation 14A, which proxy statement will be filed with the SEC not later than 120 days after the close of our fiscal year ended
December 31, 2016.
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
PART IV
(a)
Documents filed as part of Form 10-K.
(1) Financial Statements
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets
Consolidated Statements of Operations and Comprehensive Income
Consolidated Statements of Stockholder’s Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
(2) Schedules
41
42
43
44
45
46-64
Schedules have been omitted as all required information has been disclosed in the financial statements and related footnotes.
- 66 -
(3)
Exhibits
The list of Exhibits filed as a part of this Annual Report on Form 10-K is set forth in the Exhibit Index (b) below.
Description
Filed
with this
Form 10-K
Form
Incorporated by Reference
Filing Date
with SEC
Exhibit
Number
10-K
10-K
10-K
March 13, 2015 3.1a
March 13, 2015 3.1b
3.1c
March 13, 2015
10-QSB
10-K
January 14,
1997
March 13, 2015
10-QSB
August 13,
1998
3.1
3.1e
3.1
March 9, 2009 3.7
August 1, 2016 3.1h
August 14,
2002
April 7, 2008
January 10,
2007
3.6
4.1
10.1
10-K
10-Q
10-Q
8-A12B
8-K
X
8-K
January 6, 2010
10.2
10-Q
May 3, 2016
10.2
10-Q
May 3, 2016
10.3
10-Q
May 3, 2016
10.4
Exhibit
Number
3.1a
3.1b
3.1c
3.1d
Restated Articles of Organization, as amended, of Anika Therapeutics,
Inc. (with date of filing with Secretary of State of the Commonwealth of
Massachusetts):
(a) Restated Articles of Organization (April 29, 1993)
(b) Certificate of Correction (November 10, 1993)
(c) Certificate of Vote of Directors Establishing a Series of a Class of
Stock (May 18, 1995)
(d) Articles of Amendment (January 9, 1997)
3.1e
(e) Certificate of Vote of Directors Establishing a Series of a Class of
3.1f
3.1g
3.1h
3.2
4.1
10.1
10.1a
10.2
10.2a
10.2b
10.2c
Stock (April 7, 1998)
(f) Articles of Amendment (June 3, 1998)
(g) Articles of Amendment (April 4, 2008)
(h) Articles of Amendment (June 8, 2016)
Amended and Restated Bylaws of Anika Therapeutics, Inc.
Shareholder Rights Agreement, dated as of April 7, 2008, between Anika
Therapeutics, Inc. and American Stock Transfer & Trust Company
Lease, dated January 3, 2007, between Anika Therapeutics, Inc. and
Farley White Wiggins, LLC, relating to 32 Wiggins Avenue, Bedford,
Massachusetts
Amendment No. 1 to Lease, dated February 1, 2007, between Anika
Therapeutics, Inc. and Farley White Wiggins, LLC, relating to 32
Wiggins Avenue, Bedford, Massachusetts
Lease Agreement, dated December 30, 2009, between Fidia Farmaceutici
S.p.A. and Fidia Advanced Biopolymers S.r.l., relating to Via Ponte della
Fabbrica 3/A and 3/B Abano Terme, Padua, Italy
Amendment No. 1 to Lease Agreement, dated June 18, 2010, between
Fidia Farmaceutici S.p.A. and Anika Therapeutics S.r.l. (formerly Fidia
Advanced Biopolymers S.r.l.) relating to Via Ponte Della Fabbrica 3/A
and 3/B Abano Terme, Padua, Italy
Amendment No. 2 to Lease Agreement, dated September 20, 2010,
between Fidia Farmaceutici S.p.A. and Anika Therapeutics S.r.l.
(formerly Fidia Advanced Biopolymers S.r.l.) relating to Via Ponte Della
Fabbrica 3/A and 3/B Abano Terme, Padua, Italy
Translation of Amendment No. 3 to Lease Agreement, dated April 16,
2012, between Fidia Farmaceutici S.p.A. and Anika Therapeutics S.r.l.
(formerly Fidia Advanced Biopolymers S.r.l.) relating to Via Ponte Della
Fabbrica 3/A and 3/B Abano Terme, Padua, Italy
- 67 -
Exhibit
Number
10.2d
10.3
10.3a
10.4a
10.4b
10.4c
10.5
10.6
10.6a
10.7
*10.8
*10.9
†10.10a
Description
Filed
with this
Form 10-K
Form
Incorporated by Reference
Filing Date
with SEC
Exhibit
Number
Translation of Amendment No. 4 to Lease Agreement, dated February
22, 2016, between Fidia Farmaceutici S.p.A. and Anika Therapeutics
S.r.l. (formerly Fidia Advanced Biopolymers S.r.l.) relating to Via Ponte
Della Fabbrica 3/A and 3/B Abano Terme, Padua, Italy
Translation of Lease Agreement, dated October 9, 2015, between Anika
Therapeutics S.r.l. and Consorzio Zona Industriale E Porto Fluviale di
Padova relating to Land Registry of the Municipality of Padova, Page
148, cadastral map 516 and 517
Translation of Amendment No. 1 to Lease Agreement, dated February 2,
2017, between Anika Therapeutics S.r.l. and Consorzio Zona Industriale
E Porto Fluviale di Padova relating to Land Registry of the Municipality
of Padova, Page 148, cadastral map 516 and 517
Credit Agreement with Bank of America, N.A.:
(a) Credit Agreement, dated as of January 31, 2008, among Anika
Therapeutics, Inc., Anika Securities, Inc. and Bank of America, N.A., as
administrative agent
(b) Consent and First Amendment, dated as of December 30, 2009, by
and among Anika Therapeutics, Inc., Anika Securities, Inc. and Bank of
America, N.A., as administrative agent
(c) Pledge Agreement on a Quota of Fidia Advanced Biopolymers S.r.l.,
dated March 12, 2010, by Anika Therapeutics, Inc. in favor of Bank of
America, N.A., as agent bank
Sale and Purchase Agreement, dated December 30, 2009, by and between
Fidia Farmaceutici S.p.A. and Anika Therapeutics, Inc.
Tolling Agreement, dated December 30, 2009, between Fidia
Farmaceutici S.p.A. and Fidia Advanced Biopolymers S.r.l.
Amendment No. 1 to Tolling Agreement, dated January 1, 2012, between
Fidia Farmaceutici S.p.A. and Anika Therapeutics S.r.l. (formerly Fidia
Advanced Biopolymers S.r.l.)
Registration Rights Agreement, dated December 30, 2009, between
Anika Therapeutics, Inc. and Fidia Farmaceutici S.p.A.
License Agreement, dated as of December 20, 2003, by and between
Anika Therapeutics, Inc. and Ortho Biotech Products, L.P.
License Agreement, dated as of December 21, 2011, by and between
Anika Therapeutics, Inc. and DePuy Mitek, Inc.
2003 Stock Option and Incentive Plan:
(a) Second Amended and Restated 2003 Stock Option and Incentive
Plan (adopted April 5, 2011)
X
X
10-Q
May 3, 2016
10.5
8-K
October 14,
2015
10.1
8-K
February 6,
2008
10.1
8-K
January 6, 2010
10.4
10-Q
May 10, 2010
10.1
8-K
January 6, 2010
2.1
8-K
January 6, 2010
10.3
8-K
January 6, 2010
10.1
10-K
March 30, 2004
10.38
8-K
December 22,
2011
10.1
8-K
June 10, 2011
10.1
†10.10b
(b) Amendment to Second Amended and Restated 2003 Stock Option
8-K
June 21, 2013
10.1
and Incentive Plan (adopted April 11, 2013)
- 68 -
Exhibit
Number
Description
Filed
with this
Form 10-K
Form
Incorporated by Reference
Filing Date
with SEC
Exhibit
Number
†10.10c (c) Form of Incentive Stock Option Agreement
†10.10d
(d) Form of Non-Qualified Stock Option Agreement for Non-Employee
8-K
8-K
October 5, 2004 10.3
10.4
October 5, 2004
Directors
†10.10e
(e) Form of Performance Share Award Agreement
†10.10f
(f) Form of Restricted Deferred Stock Unit Award Agreement for Non-
Employee Directors
†10.10g (g) Form of Restricted Stock Award Agreement for Employees
†10.10h (h) Form of Stock Appreciation Right Agreement for Employees
†10.10i
(i) Form of Stock Appreciation Right Agreement for Non-Employee
Directors
†10.11
†10.12
†10.13a
†10.13b
†10.14a
†10.14b
†10.15a
†10.15b
†10.16
†10.17a
†10.17b
†10.18
†10.19
†10.20
10.21
Anika Therapeutics, Inc. Senior Executive Incentive Compensation Plan
Anika Therapeutics, Inc. Non-Employee Director Compensation Policy
Employment Agreement, dated March 22, 2010, between Anika
Therapeutics, Inc. and Sylvia Cheung
Amendment No. 1 to the Employment Agreement, dated December 8,
2010, by and between Anika Therapeutics, Inc. and Sylvia Cheung
Employment Agreement, dated September 10, 2009, between Anika
Therapeutics, Inc. and Frank J. Luppino
Amendment No. 1 to Employment Agreement, dated December 1, 2010,
by and between Anika Therapeutics, Inc. and Frank J. Luppino
Employment Agreement, dated September 10, 2009, between Anika
Therapeutics, Inc. and William J. Mrachek
Amendment No. 1 to Employment Agreement, dated December 1, 2010,
by and between Anika Therapeutics, Inc. and William J. Mrachek
Employment Agreement, dated October 17, 2008, between Anika
Therapeutics, Inc. and Kevin Quinlan
Employment Agreement, dated October 17, 2008, between Anika
Therapeutics, Inc. and Charles H. Sherwood, Ph.D.
Amendment No. 1 to Employment Agreement, dated December 8, 2010,
by and between Anika Therapeutics, Inc. and Charles H. Sherwood,
Ph.D.
Separation Agreement, effective November 26, 2014, by and between
Anika Therapeutics, Inc. and Carol Barnett
Separation Agreement, effective November 7, 2014, by and between
Anika Therapeutics, Inc. and John W. Sheets
Consulting Agreement, effective December 8, 2015, by and between
Anika Therapeutics, Inc. and John C. Moran
Fixed Dollar Accelerated Share Repurchase Transaction Confirmation
entered into as of February 26, 2016 by and between Morgan Stanley &
Co. LLC and Anika Therapeutics, Inc.
8-K
10-K
February 6,
2008
March 9, 2009
10.3
10.25
10-K
10-Q
10-Q
March 12, 2008 10.27
10.1
May 9, 2006
10.2
May 9, 2006
8-K
February 6,
2008
10.2
10-K
10-K
March 12, 2008 10.28
10.42
May 5, 2014
10-K
May 5, 2014
10.43
8-K
10-K
8-K
10-K
8-K
8-K
10-K
September 14,
2009
March 16, 2011
10.1
10.35
September 14,
2009
March 16, 2011
10.2
10.36
October 22,
2008
October 22,
2008
March 16, 2011
10.2
10.1
10.33
10-K
March 13, 2015
10.16
10-K
March 13, 2015
10.17
8-K
10-Q
December 9,
2015
May 3, 2016
10.1
10.1
- 69 -
Exhibit
Number
Description
Filed
with this
Form 10-K
Form
Incorporated by Reference
Filing Date
with SEC
Exhibit
Number
21.1
23.1
31.1
31.2
**32.1
***101
†
*
**
List of Subsidiaries of Anika Therapeutics, Inc.
Consent of PricewaterhouseCoopers LLP
X
X
X
X
X
X
Certification of Principal Executive Officer pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002
Certification of Principal Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
The following materials from the Annual Report on Form 10-K of Anika
Therapeutics, Inc. for the fiscal year ended December 31, 2015, formatted
in xBRL: (i) Consolidated Balance Sheets as of December 31, 2015 and
December 31, 2014; (ii) Consolidated Statements of Operations for the
Years Ended December 31, 2015, December 31, 2014, and December 31,
2013; (iii) Consolidated Statements of Stockholders’ Equity for the Years
Ended December 31, 2015, December 31, 2014, and December 31, 2013;
(iv) Consolidated Statements of Cash Flows for the Years Ended
December 31, 2015, December 31, 2014, and December 31, 2013; and
(v) Notes to Consolidated Financial Statements
Management contract or compensatory plan or arrangement.
Certain portions of this document have been omitted pursuant to a confidential treatment request filed with the Securities and
Exchange Commission. The omitted portions have been filed separately with the Commission.
The certification attached as Exhibit 32.1 that accompanies this Form 10-K is not deemed filed with the SEC and is not to be
incorporated by reference into any filing of Anika Therapeutics, Inc. under the Securities Act of 1933 or the Securities Exchange
Act of 1934, whether made before or after the date of this Form 10-K, irrespective of any general incorporation language contained
in such filing.
*** Pursuant to Rule 406T of Regulation S-T, XBRL (Extensible Business Reporting Language) information is deemed not filed or a
part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Act of 1933, is deemed not filed for
purposes of section 18 of the Securities Exchange Act of 1934 and otherwise is not subject to liability under these sections.
- 70 -
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SIGNATURES
Date: February 24, 2017
ANIKA THERAPEUTICS, INC.
By:
/s/ CHARLES H. SHERWOOD, PH.D.
Charles H. Sherwood, Ph.D.
President and Chief Executive Officer
SIGNATURES
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
Date
/s/ CHARLES H. SHERWOOD, PH.D.
Charles H. Sherwood, Ph.D.
President and Chief Executive Officer Director
(Principal Executive Officer)
/s/ SYLVIA CHEUNG
Sylvia Cheung
/s/ JOSEPH L. BOWER
Joseph L. Bower
/s/ RAYMOND J. LAND
Raymond J. Land
/s/ GLENN R. LARSEN, PH.D.
Glenn R. Larsen
/s/ JEFFERY S. THOMPSON
Jeffery S. Thompson
/s/ STEVEN E. WHEELER
Steven E. Wheeler
Chief Financial Officer
(Principal Accounting Officer)
Director
Director
Director
Director
Director
February 24, 2017
February 24, 2017
February 24, 2017
February 24, 2017
February 24, 2017
February 24, 2017
February 24, 2017
-71-
SUBSIDIARIES OF ANIKA THERAPEUTICS, INC.
Name of Subsidiary
Anika Securities Corp.
Jurisdiction of Formation
Massachusetts
Anika Therapeutics S.r.l.
(Formerly: Fidia Advanced Biopolymers S.r.l.)
Italy
EXHIBIT 21.1
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CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (Nos. 333-06275, 333-66831,
333-79047, 333-58264, 333-110326, 333-160102, 333-176103 and 333-190597) of Anika Therapeutics, Inc. of our report dated February
24, 2017 relating to the financial statements and the effectiveness of internal control over financial reporting, which appears in this Form
10-K.
EXHIBIT 23.1
/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
February 24, 2017
-73-
I, Charles H. Sherwood, certify that:
CERTIFICATION
EXHIBIT 31.1
1.
I have reviewed this annual report on Form 10-K for the year ended December 31, 2016 of Anika Therapeutics, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading
with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods
presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and
procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed
under our supervision, to ensure that material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is
being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our
conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;
and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial
reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and
report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the
registrant’s internal control over financial reporting.
Date: February 24, 2017
/s/ CHARLES H. SHERWOOD, PH.D.
Charles H. Sherwood, Ph.D.
President and Chief Executive Officer
(Principal Executive Officer)
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EXHIBIT 31.2
I, Sylvia Cheung, certify that:
CERTIFICATION
1.
I have reviewed this annual report on Form 10-K for the year ended December 31, 2016 of Anika Therapeutics, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading
with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods
presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and
procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed
under our supervision, to ensure that material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is
being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our
conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;
and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial
reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and
report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the
registrant’s internal control over financial reporting.
Date: February 24, 2017
/s/ SYLVIA CHEUNG
Sylvia Cheung
Chief Financial Officer
(Principal Financial Officer)
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EXHIBIT 32.1
CERTIFICATION
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18,
United States Code), each of the undersigned officers of Anika Therapeutics, Inc., a Massachusetts corporation (the “Company”),
does hereby certify, to such officer’s knowledge, that:
The Annual Report on Form 10-K for the year ended December 31, 2016 (the “Form 10-K”) of the Company fully complies
with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Form
10-K fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: February 24, 2017
/s/ CHARLES H. SHERWOOD, PH.D.
Charles H. Sherwood, Ph.D.
President and Chief Executive Officer
(Principal Executive Officer)
/s/ SYLVIA CHEUNG
Sylvia Cheung
Chief Financial Officer
(Principal Financial Officer)
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by
the Company and furnished to the Securities and Exchange Commission or its staff upon request.
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Anika Therapeutics, Inc.
32 Wiggins Avenue
Bedford, MA 01730
(781) 457-9000
www.anikatherapeutics.com
BR035255-0417-AR