Ireland
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98-1341933
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State or other jurisdiction of incorporation or organization
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(I.R.S. Employer Identification No.)
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Block 10-1, Blanchardstown Corporate Park
Ballycoolin
Dublin 15, Ireland
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Not Applicable
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(Address of principal executive offices)
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(Zip Code)
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Registrant's telephone number, including area code: +011-1-485-1200
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American Depositary Shares*
Ordinary Shares**
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NASDAQ Stock Market LLC
(NASDAQ Global Market)
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Title of each class
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Name of exchange on which registered
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*
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American Depositary Shares may be evidenced by American Depository Receipts. Each American Depositary Share represents one (1) Ordinary Share.
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**
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Nominal value $0.01 per share. Not for trading, but only in connection with the listing of American Depositary Shares.
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Page #
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Item 1.
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Item 1A.
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Item 1B.
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Item 2.
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Item 3.
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Item 4.
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Item 5.
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Item 6.
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Item 7.
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Item 7A.
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Item 8.
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Item 9.
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Item 9A.
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Item 9B.
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Item 10.
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Item 11.
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Item 12.
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Item 13.
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Item 14.
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Item 15.
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we depend on a small number of products and customers for the majority of our revenues and the loss of any one of these products or customers could reduce our revenues significantly.
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we may depend on partnership arrangements or strategic alliances for the commercialization of some of our products, and the failure of any third party to fulfill its duties under such an arrangement or alliance could have a material adverse effect on our financial condition and results of operation.
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our products may not reach the commercial market for a number of reasons, which would adversely affect our future revenues.
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we must invest substantial sums in research and development (“R&D”) in order to remain competitive, and we may not fully recover these investments.
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the development of several of our drug delivery platforms and products depends on the services of a single provider and any interruption of such provider’s operations could significantly delay or have a material adverse effect on our product pipeline.
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we depend upon a limited number of suppliers to manufacture our products and to deliver certain raw materials used in our products and the failure of any such supplier to timely deliver sufficient quantities of products or raw materials could have a material adverse effect on our business.
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if our competitors develop and market technologies or products that are more effective or safer than ours, or obtain regulatory approval and market such technologies or products before we do, our commercial opportunity will be diminished or eliminated.
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if third party payors choose not to reimburse our pediatric products our sales and profitability could suffer.
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if we cannot keep pace with the rapid technological change in our industry, we may lose business, and our drug delivery platforms could become obsolete or noncompetitive.
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the impact of the acquisition of FSC on our financial results may be worse than the assumptions we have used.
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if we cannot adequately protect our intellectual property and proprietary information, we may be unable to sustain a competitive advantage.
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our effective tax rate could be highly volatile and could adversely affect our operating results.
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we depend on key personnel to execute our business plan and the loss of any one or more of these key personnel may limit our ability to effectively pursue our business plan.
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the development of differentiated, patent protected products through application of the Company’s proprietary patented drug delivery platforms, Micropump® and LiquiTime®, that target high-value solid and liquid oral and alternative dosages forms through the U.S. Food and Drug Administration (FDA) 505(b)(2) approval process, which allows a sponsor to submit an application that doesn’t depend on efficacy, safety, and toxicity data created by the sponsor. In addition to Micropump® and LiquiTime®, the Company has two other proprietary drug delivery platforms, Medusa™ (hydrogel depot technology for use with large molecules and peptides) and Trigger Lock™ (controlled release of opioid analgesics with potential abuse deterrent properties).
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the identification of Unapproved Marketed Drugs (“UMDs”), which are currently sold in the U.S., but unapproved by the FDA, and the pursuit of approval for these products via a 505(b)(2) New Drug Application (NDA). To date, the Company has received approvals through this “unapproved-to-approved” avenue for three products: Bloxiverz® (neostigmine methylsulfate injection), Vazculep® (phenylephrine hydrochloride injection) and Akovaz® (ephedrine sulfate injection). As a potential source of near-term revenue growth, Avadel is working on the development of a fourth product for potential NDA submission by year-end 2017, and seeks to identify additional product candidates for development with this strategy.
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the acquisition of commercial and or late-stage products or businesses. The Company markets three branded pediatric-focused pharmaceutical products in the primary care space, and a 510(k) approved device that will launch in the second quarter of 2017, all of which were purchased through the acquisition of FSC Laboratories and FSC Pediatrics on February 5, 2016. We will consider further acquisitions, and the Company continues to look for assets that could fit strategically into its current or potential future commercial sales force.
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Flamel ceased to exist as a separate entity and the Company continued as the surviving entity and assumed all of the assets and liabilities of Flamel.
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our authorized share capital is $5,500 divided into
500,000,000
ordinary shares with a nominal value of
$0.01
each and
50,000,000
preferred shares with a nominal value of
$0.01
each
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◦
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all outstanding ordinary shares of Flamel,
€0.122
nominal value per share, were canceled and exchanged on a one-for-one basis for newly issued ordinary shares of the Company,
$0.01
nominal value per share. This change in nominal value of our outstanding shares resulted in our reclassifying
$5,937
on our balance sheet from ordinary shares to additional paid-in capital
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our board of directors is authorized to issue preferred shares on a non-pre-emptive basis, for a maximum period of five years, at which point it may be renewed by shareholders. The board of directors has discretion to dictate terms attached to the preferred shares, including voting, dividend, conversion rights, and priority relative to other classes of shares with respect to dividends and upon a liquidation.
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all outstanding American Depositary Shares (ADSs) representing ordinary shares of Flamel were canceled and exchanged on a one-for-one basis for ADSs representing ordinary shares of the Company.
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Continued Development of our Drug Delivery Technologies
: Our versatile, proprietary drug delivery platforms (Micropump®, LiquiTime®, Trigger Lock™, Medusa™) allow us to select unique product development opportunities, representing either “life cycle” opportunities, whereby additional intellectual property (IP) can be added to a pharmaceutical to extend the commercial viability of a product, for marketed chemical and biological drugs (via 505(b)(2) approval), or innovative formulation opportunities for new chemical entities (NCE) or new biological entities (NBE) (via NDA regulatory path). Several products formulated using our proprietary drug delivery platforms are currently under various stages of development. These products will be marketed either by the Company and/or by partners via licensing/distribution agreements (see “- Other Products Under Development - Proprietary pipeline to deliver several regulatory filings (US and/or EU) through 2018”) in this Part I, Item 1 of this Annual Report on Form 10-K).
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Continued exploration and development of additional unapproved to approved drug products:
Our unapproved to approved drug development process may provide us with near term revenue growth and provide cash flows that can be used to fund R&D and inorganic initiatives.
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Inorganic growth through Acquisitions and/or Partnerships
: The Company maintains a strong balance sheet with substantial liquidity and no long-term debt with fixed maturities. The Company intends to explore and pursue appropriate inorganic growth opportunities that complement its drug delivery platforms or to acquire proprietary products that enhance profitability and cash flow. This goal was evidenced in early 2016 with the acquisition of FSC Holdings, LLC and its subsidiaries, specialty pharmaceutical companies which focus on the commercialization of pediatric products and devices. The acquisition of the FSC companies adds to our marketing and licensing knowledge of commercial processes in the U.S, which we believe enhances our ability to identify potential product candidates for development, leverages new opportunities for the application of our drug delivery platforms, and establishes a commercial footprint to license and market products in the U.S.
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Divestitures and out licensing:
We intend to narrow our focus to our two most developed drug delivery platforms, Micropump® and LiquiTime®, and plan to divest or out-license Trigger Lock™, for abuse deterrence, and Medusa™, for extended-release subcutaneous injection. We believe the Trigger Lock™ and Medusa™ platforms are robust and well protected from an IP standpoint; however, their development and FDA approval may require investments in clinical work and infrastructure which we are not currently prepared to support. In 2015, the Company entered into a transaction in which it granted Elan Pharma International Limited an exclusive U.S. license to use the Company’s LiquiTime technology for Over-the-Counter ("OTC") products.
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Proprietary Product Pipeline
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Platform / Strategy
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Drug/Product
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Indication
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Stage
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Micropump®
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Sodium oxybate
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EDS / Cataplexy
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Phase III trial ongoing
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UMD #4
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Sterile Injectable - Drug Undisclosed
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Undisclosed
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Development ongoing; target filing year end 2017
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Pediatrics
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flexichamber®
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Asthma
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540(k) approval; launch 1H 2017
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LiquiTime®
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Guaifenesin
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Cough / Cold
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Pivotal trial to commence pending stability data 1H 2017
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LiquiTime®
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Undisclosed
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CNS
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Proof of concept
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LiquiTime®
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Undisclosed
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Pediatric
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Proof of concept
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Micropump®
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Undisclosed
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Pediatric
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Proof of concept
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Micropump®
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Undisclosed
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Psychiatric
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Proof of concept
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Trigger Lock™
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Hydromorphone
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Pain
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PK work complete; seeking divestiture / partner to continue development
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Medusa™
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Exenatide
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Diabetes
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Phase 1(b) complete; seeking divestiture / partner to continue development
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Avadel’s Drug Delivery
Platforms |
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Competition Category*
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Selected Competitive Companies*
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Micropump® (oral)
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Solid sustained release
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Alkermes plc; COSMO Pharmaceuticals SpA; Depomed, Inc.; Durect Corp.; Supernus Pharmaceuticals, Inc.; Veloxis Pharmaceuticals A/S (
formerly LifeCycle Pharma
)
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LiquiTime® (oral)
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Liquid sustained release
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Neos Therapeutics, Inc. (“Neos”); Tris Pharma, Inc. (“Tris”)
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Trigger-Lock™ (oral)
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Abuse resistance
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Acura Pharmaceuticals, Inc.; Altus Formulation, Cima (Cephalon); Collegium Pharmaceutical, Inc.; Durect Corp.; Egalet Corporation; Elite Pharmaceuticals, Inc.; Ethypharm; Grünenthal Group; Intellipharmaceutics International, Inc.; QRx Pharma, Ltd.; KemPharm, Inc.
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Medusa™ (injectable)
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Depot
(PLA/PLGA microspheres, liposomes and other technologies)
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Alkermes plc.; Biodel Inc.; Debiopharm Group; Durect Corp.; LG Life Sciences; InnoCore Pharmaceuticals; Marina Biotech, Inc. (
Novosom AG technology
); MedinCell SA; Octoplus N.V. (
subsidiary of Dr. Reddy’s);
Onxeo (
formerly BioAlliance Pharma
); Pacira Pharmaceuticals, Inc.; Q Chip Ltd. (
Midatech
); REcoly N.V.; Soligenix, Inc. (
formerly DOR BioPharma Inc
); Surmodics, Inc.; Xenetic Biosciences plc. (
formerly Lipoxen plc
)
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improvements in bioavailability
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pharmacokinetic improvements
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enhanced efficacy
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reduction of adverse events
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improved patient compliance
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Laboratory-based in vitro manipulation and extraction studies (Category 1) - Success with Trigger Lock
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Pharmacokinetic studies (Category 2) - Success with Trigger Lock
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Clinical abuse potential studies (Category 3) - To be required prior to marketing
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Analysis of post marketing data to assess the impact of an abuse-resistant formulation on actual abuse in a community setting (Category 4) - To be performed post marketing
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Proven biologic drugs with established markets and proven clinical development approaches;
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Product differentiation e.g. improvement of pharmacokinetic (and potentially pharmacodynamics) parameters;
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Protection of market position through product differentiation and/or patent extension; and,
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Ability to grow market share and resist price competition.
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US
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EUROPE
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ROW*
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TOTAL
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Granted patents
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19
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194
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112
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325
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Pending patent applications
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18
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12
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37
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67
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Patents granted in 2016
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3
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21
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9
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33
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Patent applications filed in 2016
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5
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—
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—
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5
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Drug Delivery
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Date of expiration of granted patents
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Platforms
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U.S.
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Europe
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Micropump®
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July 2027
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May 2030
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LiquiTime®
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September 2025
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April 2023
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Trigger Lock™
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April 2027
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May 2026
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Medusa™
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June 2031
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November 2024
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Micropump® platform
is patented under multiple granted patents. Among them is Avadel’s Micropump®-related key patent, WO 2003/030878, which discloses an efficacious coating formulation for providing delayed and sustained release of an active ingredient with absorption limited to the upper part of intestinal tract. It is granted in the U.S. as US Patent 8,101,209 and will expire on October 2025. Equivalent patents are granted in China, Hong Kong, Israel, India, Singapore, Japan, South Korea, Canada, South Africa, Mexico (expiry date: October 2022) and in France (expiry date: October 2021). Patent applications are pending in Brazil and Europe; and, would expire on October 2022.
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LiquiTime® platform
is protected by Avadel’s patent granted in the U.S. (US 7,906,145; expiry date: September 2025) and in South Korea, Canada, Israel, Japan, Australia, China, Austria, Belgium, Switzerland, Liechtenstein, Germany, Spain, France, United Kingdom, Italy, Ireland, Luxembourg, Netherlands, Portugal, Sweden, Turkey, India, Mexico, South Africa that expire in April 2023. A patent application is pending in Brazil and 3 continuation application are pending in the U.S.
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Trigger Lock platform
is protected by 7 (seven) Avadel patent application families. Within these patent families, 12 (twelve) patents are granted in the U.S., Europe and Japan; and, 20 (twenty) patent applications are pending including other countries and will expire between November 2025 and December 2033.
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Medusa platform
is patented under Avadel’s key patent WO 2003/104303 granted in the U.S. and which will expire in July 2023. Equivalent patents to WO 2003/104303 are granted in China, Israel, Mexico, Australia, Japan, South Korea, Canada, Europe, India and South Africa. A patent application is pending in Brazil. These patents will expire in June 2023.
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Medusa-based nanogels are protected by issued patents from WO 2005/051416’ family in the U.S., Australia, China, Israel, Japan, South Korea, Mexico, South Africa, India, Canada and Europe expiring on November 2024. Corresponding patent application is pending in Brazil
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Medusa-based microgels are protected by granted patents from WO 2007/141344’ patents family in the U.S., Australia, Japan, Canada, China, Israel, South Korea, Mexico and South Africa. Patent applications are pending in Europe, India and Brazil. This patents family will expire on June 2027
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the scope of regulatory approvals, including limitations or warnings in a product’s regulatory-approved labeling;
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in the case of any new "unapproved-marketed-drug" product we may successfully pursue, whether and the extent to which the FDA removes competing products from the market;
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demonstration of the clinical safety and efficacy of the product or technology;
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the absence of evidence of undesirable side effects of the product or technology that delay or extend trials;
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the lack of regulatory delays or other regulatory actions;
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its cost-effectiveness;
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its potential advantage over alternative treatment methods;
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the availability of third-party reimbursement; and
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the marketing and distribution support it receives.
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the FDA, the European Medicines Agency (“EMA”), the competent authority of an EU Member State or an Institutional Review Board (“IRB”), or an Ethics Committee (EU equivalent to IRB), or our partners may delay or halt applicable clinical trials;
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we or our partners may face slower than expected rate of patient recruitment and enrollment in clinical trials, or may devote insufficient funding to the clinical trials;
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our drug delivery platforms and drug products may be found to be ineffective or cause harmful side effects, or may fail during any stage of pre-clinical testing or clinical trials;
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we or our partners may find certain products cannot be manufactured on a commercial scale and, therefore, may not be economical or feasible to produce;
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managed care providers may be unwilling or unable to reimburse patients at an economically attractive level for our products; or
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our products could fail to obtain regulatory approval or, if approved, fail to achieve market acceptance, fail to be included within the pricing and reimbursement schemes of the U.S. or EU Member States, or be precluded from commercialization by proprietary rights of third parties.
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the amount of intangible assets that will result from the acquisition;
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the impact of fair value adjustments to related party payables as a result of changes in estimated probability and timing of achieving the targets;
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acquisition costs, including transaction and integration costs, as well as operating costs going forward;
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the impact of impairment and other charges if the FSC products are unsuccessful; and
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other financial and strategic risks of the acquisition.
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the jurisdictions in which profits are determined to be earned and taxed;
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increases in expenses not deductible for tax purposes, including increases in the fair value of related party payables, write-offs of acquired in-process R&D and impairment of goodwill in connection with acquisitions;
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changes in domestic or international tax laws or the interpretation of such tax laws;
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adjustments to estimated taxes upon finalization of various tax returns;
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changes in available tax credits;
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changes in share-based compensation expense;
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changes in the valuation of our deferred tax assets and liabilities;
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the resolution of issues arising from tax audits with various tax authorities; and
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the tax effects of purchase accounting for acquisitions that may cause fluctuations between reporting periods.
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adverse drug experiences and other reporting requirements;
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product promotion and marketing;
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active pharmaceutical ingredients and/or product manufacturing, including cGMP compliance;
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record keeping;
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distribution of drug samples;
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required clinical trials and/or post-marketing studies;
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authorization renewal procedures;
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authorization variation procedures;
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compliance with any required REMS;
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updating safety and efficacy information;
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processing of personal data;
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use of electronic records and signatures; and
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changes to product manufacturing or labeling.
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obtaining regulatory approval to commence a trial;
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reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
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obtaining institutional review board or ethics committee approval at each site;
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recruiting suitable patients to participate in a trial;
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having patients complete a trial or return for post-treatment follow-up;
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clinical sites dropping out of a trial;
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adding new sites; or
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manufacturing sufficient quantities of medicine candidates for use in clinical trials.
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issue warning letters;
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impose fines;
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seize products or request or order recalls;
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issue injunctions to stop future sales of products;
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refuse to permit products to be imported into, or exported out of, the United States or the European Union;
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suspend or limit our production;
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withdraw or vary approval of marketing applications;
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order the competent authorities of EU Member States to withdraw or vary national authorization; and
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initiate criminal prosecutions.
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warning letters or untitled letters;
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fines and civil penalties;
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delays in clearing or approving, or refusal to clear or approve, products;
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withdrawal, suspension or variation of approval of products; product recall or seizure;
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orders to the competent authorities of EU Member States to withdraw or vary national authorization;
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orders for physician notification or device repair, replacement or refund;
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interruption of production;
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operating restrictions;
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injunctions; and
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criminal prosecution.
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fluctuations in our operating results;
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announcements of technological partnerships, innovations or new products by us or our competitors;
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actions with respect to the acquisition of new or complementary businesses;
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governmental regulations;
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developments in patent or other proprietary rights owned by us or others;
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public concern as to the safety of drug delivery platforms developed by us or drugs developed by others using our platform;
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the results of pre-clinical testing and clinical studies or trials by us or our competitors;
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adverse events related to our products or products developed by pharmaceutical and biotechnology company partners that use our drug delivery platforms;
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lack of efficacy of our products;
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litigation;
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decisions by our pharmaceutical and biotechnology company partners relating to the products incorporating our technologies;
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the perception by the market of specialty pharma, biotechnology, and high technology companies generally; and
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general market conditions, including the impact of the current financial environment.
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the demand for our drug delivery platforms and products;
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the level of product and price competition;
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our ability to develop new partnerships and additional commercial applications for our products;
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our ability to control our costs;
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our ability to broaden our customer base;
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the effectiveness of our marketing strategy;
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the effectiveness of our partners’ marketing strategy for products that use our technology; and
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general economic conditions.
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•
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the development and acquisition of new products and drug delivery platforms;
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the progress of our research and product development programs;
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results of our partnership efforts with potential pharmaceutical and biotechnology company partners; and
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•
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the timing of, and amounts received from, future product sales, product development fees and licensing revenue and royalties.
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permit our board of directors to issue preferred shares with such rights and preferences as they may designate, subject to applicable law;
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impose advance notice requirements for shareholder proposals and director nominations to be considered at annual shareholder meetings; and
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require the approval of a supermajority of the voting power of the shares of our share capital entitled to vote generally at a meeting of shareholders to amend or repeal certain provisions of our articles of association.
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Effect service of process within the U.S. against us and our non-U.S. resident directors and officers;
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enforce United States court judgments based upon the civil liability provisions of the United States federal securities laws against us and our non-U.S. resident directors and officers in Ireland; or
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bring an original action in an Irish court to enforce liabilities based upon the U.S. federal securities laws against us and our non-U.S. resident directors and officers.
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Item 5.
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Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
|
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2016 Price Range
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2015 Price Range
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||||||||||||
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High
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Low
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High
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Low
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||||||||
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||||||||
First quarter
|
$
|
12.92
|
|
|
$
|
7.85
|
|
|
$
|
18.47
|
|
|
$
|
11.50
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Second quarter
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13.32
|
|
|
8.83
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|
|
22.32
|
|
|
13.88
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|
||||
Third quarter
|
14.89
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|
|
11.01
|
|
|
25.69
|
|
|
15.37
|
|
||||
Fourth quarter
|
13.16
|
|
|
9.26
|
|
|
19.27
|
|
|
12.21
|
|
Statement of Income (Loss) Data:
|
|
2016
|
|
2015
(b)
|
|
2014
(b)
|
|
2013
(b)
|
|
2012
(b)
|
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|||||
Revenues
|
|
$
|
150,246
|
|
|
$
|
173,009
|
|
|
$
|
14,975
|
|
|
$
|
4,179
|
|
|
$
|
7,534
|
|
Gross profit
(a)
|
|
136,998
|
|
|
161,599
|
|
|
11,592
|
|
|
3,617
|
|
|
7,134
|
|
|||||
Operating income (loss)
|
|
(4,965
|
)
|
|
70,758
|
|
|
(93,657
|
)
|
|
(53,700
|
)
|
|
(9,913
|
)
|
|||||
Net income (loss) from continuing operations
|
|
(41,276
|
)
|
|
41,798
|
|
|
(89,487
|
)
|
|
(46,176
|
)
|
|
(4,380
|
)
|
|||||
Net income from discontinued operations
|
|
—
|
|
|
—
|
|
|
4,018
|
|
|
3,584
|
|
|
1,512
|
|
|||||
Net income (loss)
|
|
(41,276
|
)
|
|
41,798
|
|
|
(85,469
|
)
|
|
(42,592
|
)
|
|
(2,868
|
)
|
|||||
Earnings (loss) per share - basic:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Continuing operations
|
|
(1.00
|
)
|
|
1.03
|
|
|
(2.47
|
)
|
|
(1.81
|
)
|
|
(0.17
|
)
|
|||||
Discontinued operations
|
|
—
|
|
|
—
|
|
|
0.11
|
|
|
0.14
|
|
|
0.06
|
|
|||||
Net income (loss) per share - basic
|
|
(1.00
|
)
|
|
1.03
|
|
|
(2.36
|
)
|
|
(1.67
|
)
|
|
(0.11
|
)
|
|||||
Earnings (loss) per share - diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Continuing operations
|
|
(1.00
|
)
|
|
0.96
|
|
|
(2.47
|
)
|
|
(1.81
|
)
|
|
(0.17
|
)
|
|||||
Discontinued operations
|
|
—
|
|
|
—
|
|
|
0.11
|
|
|
0.14
|
|
|
0.06
|
|
|||||
Net income (loss) per share - diluted
|
|
(1.00
|
)
|
|
0.96
|
|
|
(2.36
|
)
|
|
(1.67
|
)
|
|
(0.11
|
)
|
Balance Sheet Data:
|
|
2016
|
|
2015
(b)
|
|
2014
(b)
|
|
2013
|
|
2012
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Cash and cash equivalents
|
|
$
|
39,215
|
|
|
$
|
65,064
|
|
|
$
|
39,760
|
|
|
$
|
6,636
|
|
|
$
|
2,742
|
|
Marketable securities
|
|
114,980
|
|
|
79,738
|
|
|
53,074
|
|
|
401
|
|
|
6,413
|
|
|||||
Goodwill
|
|
18,491
|
|
|
18,491
|
|
|
18,491
|
|
|
18,491
|
|
|
18,491
|
|
|||||
Intangible assets, net
|
|
22,837
|
|
|
15,825
|
|
|
28,389
|
|
|
40,139
|
|
|
41,589
|
|
|||||
Total assets
|
|
245,482
|
|
|
215,081
|
|
|
174,382
|
|
|
116,252
|
|
|
117,311
|
|
|||||
Long-term debt (incl. current portion)
|
|
815
|
|
|
1,118
|
|
|
3,717
|
|
|
30,249
|
|
|
10,409
|
|
|||||
Long-term related party payable (incl. current portion)
|
|
169,347
|
|
|
122,693
|
|
|
114,750
|
|
|
55,265
|
|
|
26,220
|
|
2016:
|
March 31
(b)
|
|
June 30
|
|
September 30
|
|
December 31
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||
Revenues
|
$
|
36,216
|
|
|
$
|
38,858
|
|
|
$
|
32,087
|
|
|
$
|
43,085
|
|
Gross profit
(a)
|
32,310
|
|
|
34,951
|
|
|
29,243
|
|
|
40,494
|
|
||||
Operating income (loss)
|
5,704
|
|
|
(11,543
|
)
|
|
(16,190
|
)
|
|
17,064
|
|
||||
Net income (loss)
|
(6,058
|
)
|
|
(19,958
|
)
|
|
(19,994
|
)
|
|
4,734
|
|
||||
Net income (loss) per share - basic
|
(0.15
|
)
|
|
(0.48
|
)
|
|
(0.48
|
)
|
|
0.11
|
|
||||
Net income (loss) per share - diluted
|
(0.15
|
)
|
|
(0.48
|
)
|
|
(0.48
|
)
|
|
0.11
|
|
2015:
|
March 31
(b)
|
|
June 30
(b)
|
|
September 30
(b)
|
|
December 31
(b)
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||
Revenues
|
$
|
32,526
|
|
|
$
|
48,602
|
|
|
$
|
47,313
|
|
|
$
|
44,568
|
|
Gross profit
(a)
|
28,896
|
|
|
45,846
|
|
|
45,226
|
|
|
41,631
|
|
||||
Operating income (loss)
|
10,014
|
|
|
(2,370
|
)
|
|
(14,486
|
)
|
|
77,600
|
|
||||
Net income (loss)
|
13,213
|
|
|
(16,857
|
)
|
|
(28,076
|
)
|
|
73,518
|
|
||||
Net income (loss) per share - basic
|
0.33
|
|
|
(0.42
|
)
|
|
(0.69
|
)
|
|
1.79
|
|
||||
Net income (loss) per share - diluted
|
0.31
|
|
|
(0.42
|
)
|
|
(0.69
|
)
|
|
1.69
|
|
•
|
the development of differentiated, patent protected products through application of the Company’s proprietary patented drug delivery platforms, Micropump® and LiquiTime®, that target high-value solid and liquid oral and alternative dosages forms through the U.S. Food and Drug Administration (FDA) 505(b)(2) approval process, which allows a sponsor to submit an application that doesn’t depend on efficacy, safety, and toxicity data created by the sponsor. In addition to Micropump® and LiquiTime®, the Company has two other proprietary drug delivery platforms, Medusa™ (hydrogel depot technology for use with large molecules and peptides) and Trigger Lock™ (controlled release of opioid analgesics with potential abuse deterrent properties).
|
•
|
the identification of Unapproved Marketed Drugs (“UMDs”), which are currently sold in the U.S., but unapproved by the FDA, and the pursuit of approval for these products via a 505(b)(2) New Drug Application (NDA). To date, the Company has received approvals through this “unapproved-to-approved” avenue for three products: Bloxiverz® (neostigmine methylsulfate injection), Vazculep® (phenylephrine hydrochloride injection) and Akovaz® (ephedrine sulfate injection). As a potential source of near-term revenue growth, Avadel is working on the development of a fourth product for potential NDA submission by year-end 2017, and seeks to identify additional product candidates for development with this strategy.
|
•
|
the acquisition of commercial and or late-stage products or businesses. The Company markets three branded pediatric-focused pharmaceutical products in the primary care space, and a 510(k) approved device that will launch in the second quarter of 2017, all of which were purchased through the acquisition of FSC Laboratories and FSC Pediatrics on February 5, 2016. We will consider further acquisitions, and the Company continues to look for assets that could fit strategically into its current or potential future commercial sales force.
|
•
|
Flamel ceased to exist as a separate entity and the Company continued as the surviving entity and assumed all of the assets and liabilities of Flamel.
|
•
|
our authorized share capital is $5,500 divided into
500,000
ordinary shares with a nominal value of
$0.01
each and
50,000
preferred shares with a nominal value of
$0.01
each
|
◦
|
all outstanding ordinary shares of Flamel,
€0.122
nominal value per share, were canceled and exchanged on a one-for-one basis for newly issued ordinary shares of the Company,
$0.01
nominal value per share. This change in nominal value of our outstanding shares resulted in our reclassifying
$5,937
on our balance sheet from ordinary shares to additional paid-in capital
|
◦
|
our board of directors is authorized to issue preferred shares on a non-pre-emptive basis, for a maximum period of five years, at which point it may be renewed by shareholders. The board of directors has discretion to dictate terms attached to the preferred shares, including voting, dividend, conversion rights, and priority relative to other classes of shares with respect to dividends and upon a liquidation.
|
•
|
all outstanding American Depositary Shares (ADSs) representing ordinary shares of Flamel were canceled and exchanged on a one-for-one basis for ADSs representing ordinary shares of the Company.
|
•
|
Unapproved Marketed Drug Development
: The Company derives a majority of its revenues and cash flow from its UMD products. During the twelve months ended December 31, 2016 the Company generated
$147,222
of sales from the UMD products compared to
$172,288
in the same period of 2015.
|
◦
|
The first UMD product, Bloxiverz, which had sales of
$82,896
and
$150,083
for the twelve months ended December 31, 2016 and 2015, respectively, was approved by the FDA on May 31, 2013, and is currently being marketed in the U.S.
|
◦
|
The second UMD product, Vazculep, which had sales of
$39,796
and
$20,151
for the twelve months ended December 31, 2016 and 2015, respectively, was approved by the FDA on September 27, 2014 and launched in October 2014 in the U.S.
|
◦
|
The third UMD product, Akovaz, which had sales of
$16,831
for the twelve months ended December 31, 2016, was approved by the FDA April 29, 2016. The Company began marketing this product in August 2016.
|
•
|
Development and Commercialization of the Company’s Drug Delivery Pipeline Products
: In addition to the UMD strategy, the Company is continuing to advance the development of its innovative drug delivery platforms. We have enhanced our ability to identify new product candidates and to pursue commercial opportunities associated with our drug delivery platforms. The Company’s drug delivery platforms allow the creation of competitive and differentiated drug product profiles (e.g., with improved pharmacokinetics, efficacy and/or safety). We own and develop drug delivery platforms that address key formulation challenges, leading to the development of differentiated drug products for administration in various forms (e.g., capsules, tablets, sachets or liquid suspensions for oral use; or injectables for subcutaneous administration) and can be applied to a broad range of drugs (novel, already-marketed, or off-patent). Application of these technologies to pharmaceuticals allows us to protect our potential products through patent protection and product differentiation. As a result of developing our own drug delivery platforms our business is now less dependent on the development activities performed by partners, and relies more on the development of our own, self-funded, products. Our proprietary drug delivery platforms include:
|
◦
|
Micropump®
is a microparticulate system that allows the development and marketing of modified and/or controlled release solid oral dosage formulations of drugs (Micropump®-carvedilol and Micropump®-aspirin formulations have been approved in the U.S. and in the E.U., respectively).
|
◦
|
LiquiTime®
allows development of modified/controlled release oral products in a liquid suspension formulation particularly suited to children or patients having issues swallowing tablets or capsules. Unlike most liquid pharmaceuticals, LiquiTime® technology is not limited to ionic drugs as with resin-complex based technologies and can be applied to the development of combination products.
|
◦
|
Trigger Lock™
allows development of abuse-deterrent modified/controlled release formulations of narcotic/opioid analgesics and other drugs susceptible to abuse.
|
◦
|
Medusa™
allows the development of extended/modified release of injectable dosage formulations of drugs (
e.g.,
peptides, polypeptides, proteins, and small molecules).
|
◦
|
Continuing to build commercially successful products utilizing Micropump;
|
◦
|
Identifying opportunities and optimizing time-to-market for our LiquiTime drug delivery platform;
|
◦
|
Maximizing the technical potential of our existing drug delivery platforms for developing new and proprietary products; and
|
◦
|
Developing and validating improved and complementary drug delivery platforms related to our current drug delivery capabilities.
|
•
|
Inorganic growth through Acquisitions and/or Partnerships
: The Company maintains a strong balance sheet with substantial liquidity and no long-term debt with fixed maturities. As part of its overall enterprise strategy, the Company
|
•
|
Divestitures and out licensing:
We have a stated objective to narrow our focus to our two most developed platforms, Micropump® and LiquiTime®. As a result, we are pursuing the divestiture or out licensing of Trigger Lock™ for abuse deterrence, and Medusa™ for extended-release subcutaneous injection. We believe both platforms are robust and well protected from an IP standpoint; however, their development and FDA approval will likely require substantial investments in clinical work and infrastructure, which we are not currently prepared to support.
|
•
|
Healthcare and Regulatory Reform
: Various health care reform laws in the U.S. may impact our ability to successfully commercialize our products and technologies. The success of our commercialization efforts may depend on the extent to which the government health administration authorities, the health insurance funds in the E.U. Member States, private health insurers and other third party payers in the U.S. will reimburse consumers for the cost of healthcare products and services.
|
•
|
Competition and Technological Change:
Competition in the pharmaceutical and biotechnology industry continues to be intense and is expected to increase. We compete with academic laboratories, research institutions, universities, joint ventures, and other pharmaceutical and biotechnology companies, including other companies developing niche brand or generic specialty pharmaceutical products or drug delivery platforms. Furthermore, major technological changes can happen quickly in the pharmaceutical and biotechnology industries. Such rapid technological change, or the development by our competitors of technologically improved or differentiated products, could render our drug delivery platforms obsolete or noncompetitive.
|
•
|
Pricing Environment for Pharmaceuticals
: The pricing environment continues to be in the political spotlight in the U.S. As a result, the need to obtain and maintain appropriate pricing and reimbursement for our products may become more challenging due to, among other things, the attention being paid to healthcare cost containment and other austerity measures in the U.S. and worldwide.
|
•
|
Generics Playing a Larger Role in Healthcare
: Generic pharmaceutical products will continue to play a large role in the U.S. healthcare system. Specifically, we have seen, or likely will see, additional generic competition to our current and future products and we continue to expect generic competition in the future.
|
•
|
Access to and Cost of Capital
: The cost of raising capital has recently become more expensive. If the need were to arise to raise more capital our cost will be more expensive and may create challenges for the Company. Currently, the Company has no need to raise capital.
|
•
|
Revenue was
$150,246
for the twelve months ended December 31, 2016 compared to
$173,009
in the same period last year. This decrease was primarily the result of a decrease in Bloxiverz revenues as a result of additional competition, partially offset by the August 2016 launch of Akovaz, which added
$16,831
of revenue.
|
•
|
Operating loss was
$4,965
for the twelve months ended December 31, 2016 compared to operating income of
$70,758
for the twelve months ended December 31, 2015. This decline in profitability was largely driven by the lower gross profit (revenues minus cost of goods sold) as a result of the decrease in revenues noted above, increases in SG&A and R&D and higher non-cash charges related to the adjustments to the fair value of our related party payables.
|
•
|
Net loss was
$41,276
for the twelve months ended December 31, 2016 compared to net income of
$41,798
in the same period last year. The decline to a net loss in 2016 from net income in 2015 was due to the same reasons noted above.
|
•
|
Diluted net loss per share was
$1.00
for the twelve months ended December 31, 2016 compared to net income per share of
$0.96
in the same period last year.
|
•
|
Cash and marketable securities increased
$9,393
to
$154,195
at December 31, 2016 from
$144,802
at December 31, 2015.
|
|
|
|
|
|
|
|
|
Increase / (Decrease)
|
||||||||||||||||||
|
|
Years Ended December 31,
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||||||||||||
Comparative Statements of Income (Loss):
|
|
2016
|
|
2015
(a)
|
|
2014
(a)
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Product sales and services
|
|
$
|
147,222
|
|
|
$
|
172,288
|
|
|
$
|
12,193
|
|
|
$
|
(25,066
|
)
|
|
(14.5
|
)%
|
|
$
|
160,095
|
|
|
1,313.0
|
%
|
License and research revenue
|
|
3,024
|
|
|
721
|
|
|
2,782
|
|
|
2,303
|
|
|
319.4
|
%
|
|
(2,061
|
)
|
|
(74.1
|
)%
|
|||||
Total
|
|
150,246
|
|
|
173,009
|
|
|
14,975
|
|
|
(22,763
|
)
|
|
(13.2
|
)%
|
|
158,034
|
|
|
1,055.3
|
%
|
|||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Cost of products and services sold
|
|
13,248
|
|
|
11,410
|
|
|
3,383
|
|
|
1,838
|
|
|
16.1
|
%
|
|
8,027
|
|
|
237.3
|
%
|
|||||
Research and development
|
|
34,611
|
|
|
25,608
|
|
|
17,298
|
|
|
9,003
|
|
|
35.2
|
%
|
|
8,310
|
|
|
48.0
|
%
|
|||||
Selling, general and administrative
|
|
44,179
|
|
|
21,712
|
|
|
15,698
|
|
|
22,467
|
|
|
103.5
|
%
|
|
6,014
|
|
|
38.3
|
%
|
|||||
Intangible asset amortization
|
|
13,888
|
|
|
12,564
|
|
|
11,749
|
|
|
1,324
|
|
|
10.5
|
%
|
|
815
|
|
|
6.9
|
%
|
|||||
Changes in fair value of related party contingent consideration
|
|
49,285
|
|
|
30,957
|
|
|
57,491
|
|
|
18,328
|
|
|
59.2
|
%
|
|
(26,534
|
)
|
|
(46.2
|
)%
|
|||||
Loss on early repayment of related party acquisition-related note
|
|
—
|
|
|
—
|
|
|
3,013
|
|
|
—
|
|
|
n/a
|
|
|
(3,013
|
)
|
|
(100.0
|
)%
|
|||||
Total
|
|
155,211
|
|
|
102,251
|
|
|
108,632
|
|
|
52,960
|
|
|
51.8
|
%
|
|
(6,381
|
)
|
|
(5.9
|
)%
|
|||||
Operating income (loss)
|
|
(4,965
|
)
|
|
70,758
|
|
|
(93,657
|
)
|
|
(75,723
|
)
|
|
(107.0
|
)%
|
|
164,415
|
|
|
(175.6
|
)%
|
|||||
Investment and other income
|
|
1,635
|
|
|
1,236
|
|
|
927
|
|
|
399
|
|
|
32.3
|
%
|
|
309
|
|
|
33.3
|
%
|
|||||
Interest expense
|
|
(963
|
)
|
|
—
|
|
|
(5,747
|
)
|
|
963
|
|
|
n/a
|
|
|
(5,747
|
)
|
|
(100.0
|
)%
|
|||||
Other expense - changes in fair value of related party payable
|
|
(6,548
|
)
|
|
(4,883
|
)
|
|
(3,525
|
)
|
|
1,665
|
|
|
34.1
|
%
|
|
1,358
|
|
|
38.5
|
%
|
|||||
Foreign exchange gain
|
|
1,123
|
|
|
10,594
|
|
|
11,871
|
|
|
(9,471
|
)
|
|
(89.4
|
)%
|
|
(1,277
|
)
|
|
(10.8
|
)%
|
|||||
Income (loss) before income taxes
|
|
(9,718
|
)
|
|
77,705
|
|
|
(90,131
|
)
|
|
(87,423
|
)
|
|
(112.5
|
)%
|
|
167,836
|
|
|
(186.2
|
)%
|
|||||
Income tax provision (benefit)
|
|
31,558
|
|
|
35,907
|
|
|
(644
|
)
|
|
(4,349
|
)
|
|
(12.1
|
)%
|
|
36,551
|
|
|
(5,675.6
|
)%
|
|||||
Net income (loss) from continuing operations
|
|
(41,276
|
)
|
|
41,798
|
|
|
(89,487
|
)
|
|
(83,074
|
)
|
|
(198.8
|
)%
|
|
131,285
|
|
|
(146.7
|
)%
|
|||||
Net income from discontinued operations
|
|
—
|
|
|
—
|
|
|
4,018
|
|
|
—
|
|
|
n/a
|
|
|
(4,018
|
)
|
|
(100.0
|
)%
|
|||||
Net income (loss)
|
|
$
|
(41,276
|
)
|
|
$
|
41,798
|
|
|
$
|
(85,469
|
)
|
|
$
|
(83,074
|
)
|
|
(198.8
|
)%
|
|
$
|
127,267
|
|
|
(148.9
|
)%
|
Earnings (loss) per share - diluted:
|
|
$
|
(1.00
|
)
|
|
$
|
0.96
|
|
|
$
|
(2.36
|
)
|
|
$
|
(1.96
|
)
|
|
(204.2
|
)%
|
|
$
|
3.32
|
|
|
(140.7
|
)%
|
|
|
|
|
|
|
|
|
Increase / (Decrease)
|
||||||||||||||||||
|
|
Years Ended December 31,
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||||||||||||
Cost of Products and Services Sold:
|
|
2016
|
|
2015
|
|
2014
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Cost of products and services sold
|
|
$
|
13,248
|
|
|
$
|
11,410
|
|
|
$
|
3,383
|
|
|
$
|
1,838
|
|
|
16.1
|
%
|
|
$
|
8,027
|
|
|
237.3
|
%
|
Percentage of sales
|
|
8.8
|
%
|
|
6.6
|
%
|
|
22.6
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase / (Decrease)
|
||||||||||||||||||
|
|
Years Ended December 31,
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||||||||||||
Research and Development Expenses:
|
|
2016
|
|
2015
|
|
2014
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Research and development
|
|
$
|
34,611
|
|
|
$
|
25,608
|
|
|
$
|
17,298
|
|
|
$
|
9,003
|
|
|
35.2
|
%
|
|
$
|
8,310
|
|
|
48.0
|
%
|
Percentage of sales
|
|
23.0
|
%
|
|
14.8
|
%
|
|
115.5
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase / (Decrease)
|
||||||||||||||||||
|
|
Years Ended December 31,
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||||||||||||
Selling, General and Administrative Expenses:
|
|
2016
|
|
2015
|
|
2014
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Selling, general and administrative
|
|
$
|
44,179
|
|
|
$
|
21,712
|
|
|
$
|
15,698
|
|
|
$
|
22,467
|
|
|
103.5
|
%
|
|
$
|
6,014
|
|
|
38.3
|
%
|
Percentage of sales
|
|
29.4
|
%
|
|
12.5
|
%
|
|
104.8
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase / (Decrease)
|
||||||||||||||||||
|
|
Years Ended December 31,
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||||||||||||
Intangibles Asset Amortization:
|
|
2016
|
|
2015
|
|
2014
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Intangible asset amortization
|
|
$
|
13,888
|
|
|
$
|
12,564
|
|
|
$
|
11,749
|
|
|
$
|
1,324
|
|
|
10.5
|
%
|
|
$
|
815
|
|
|
6.9
|
%
|
Percentage of sales
|
|
9.2
|
%
|
|
7.3
|
%
|
|
78.5
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase / (Decrease)
|
||||||||||||||||||
|
|
Years Ended December 31,
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||||||||||||
Changes in Fair Value of Related Party Contingent Consideration:
|
|
2016
|
|
2015
|
|
2014
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Changes in fair value of related party contingent consideration
|
|
$
|
49,285
|
|
|
$
|
30,957
|
|
|
$
|
57,491
|
|
|
$
|
18,328
|
|
|
59.2
|
%
|
|
$
|
(26,534
|
)
|
|
(46.2
|
)%
|
Percentage of sales
|
|
32.8
|
%
|
|
17.9
|
%
|
|
383.9
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase / (Decrease)
|
|||||||||||||||||
|
|
Years Ended December 31,
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
|||||||||||||||||||
Interest Expense:
|
|
2016
|
|
2015
|
|
2014
|
|
$
|
|
%
|
|
$
|
|
%
|
|||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Interest expense
|
|
$
|
963
|
|
|
$
|
—
|
|
|
$
|
5,747
|
|
|
$
|
963
|
|
|
n/a
|
|
$
|
(5,747
|
)
|
|
(100.0
|
)%
|
Percentage of sales
|
|
(0.6
|
)%
|
|
—
|
%
|
|
(38.4
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase / (Decrease)
|
||||||||||||||||||
|
|
Years Ended December 31,
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||||||||||||
Other Expense - Changes in Fair Value of Related Party Payable:
|
|
2016
|
|
2015
|
|
2014
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Other expense - changes in fair value of related party payable
|
|
$
|
6,548
|
|
|
$
|
4,883
|
|
|
$
|
3,525
|
|
|
$
|
1,665
|
|
|
34.1
|
%
|
|
$
|
1,358
|
|
|
38.5
|
%
|
Percentage of sales
|
|
(4.4
|
)%
|
|
(2.8
|
)%
|
|
(23.5
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase / (Decrease)
|
||||||||||||||||||
|
|
Years Ended December 31,
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||||||||||||
Foreign Exchange Gains:
|
|
2016
|
|
2015
|
|
2014
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Foreign exchange gain
|
|
$
|
1,123
|
|
|
$
|
10,594
|
|
|
$
|
11,871
|
|
|
$
|
(9,471
|
)
|
|
(89.4
|
)%
|
|
$
|
(1,277
|
)
|
|
(10.8
|
)%
|
Percentage of sales
|
|
0.7
|
%
|
|
6.1
|
%
|
|
79.3
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase / (Decrease)
|
||||||||||||||||||
|
|
Years Ended December 31,
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||||||||||||
Income Taxes:
|
|
2016
|
|
2015
|
|
2014
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Income tax provision (benefit)
|
|
$
|
31,558
|
|
|
$
|
35,907
|
|
|
$
|
(644
|
)
|
|
$
|
(4,349
|
)
|
|
(12.1
|
)%
|
|
$
|
36,551
|
|
|
(5,675.6
|
)%
|
Percentage of income (loss) before income taxes
|
|
(324.7
|
)%
|
|
46.2
|
%
|
|
0.7
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation to Effective Income Tax Rate:
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
|
||||||
Statutory tax rate
(1)
|
|
12.5
|
%
|
|
33.3
|
%
|
|
33.3
|
%
|
|||
Non-deductible changes in fair value of contingent consideration
|
|
(165.0
|
)%
|
|
11.9
|
%
|
|
(24.8
|
)%
|
|||
Change in valuation allowance
|
|
11.8
|
%
|
|
(9.6
|
)%
|
|
5.3
|
%
|
|||
Income tax deferred charge
|
|
(9.7
|
)%
|
|
1.3
|
%
|
|
(16.9
|
)%
|
|||
International tax rates differential
|
|
(31.9
|
)%
|
|
11.0
|
%
|
|
6.7
|
%
|
|||
Nondeductible stock based compensation
|
|
(14.8
|
)%
|
|
1.3
|
%
|
|
(0.8
|
)%
|
|||
Cross-border merger
|
|
(100.6
|
)%
|
|
—
|
%
|
|
—
|
%
|
|||
Unrecognized tax benefit
|
|
(15.2
|
)%
|
|
0.4
|
%
|
|
—
|
%
|
|||
State and local taxes (net of federal)
|
|
(9.6
|
)%
|
|
1.5
|
%
|
|
0.3
|
%
|
|||
Other
|
|
(2.3
|
)%
|
|
(4.9
|
)%
|
|
(2.3
|
)%
|
|||
Effective income tax rate
|
|
(324.8
|
)%
|
|
46.2
|
%
|
|
0.8
|
%
|
|||
|
|
|
|
|
|
|
||||||
Income tax provision (benefit) - at statutory tax rate
|
|
$
|
(1,215
|
)
|
|
$
|
25,876
|
|
|
$
|
(30,013
|
)
|
Non-deductible changes in fair value of contingent consideration
|
|
16,036
|
|
|
9,249
|
|
|
22,326
|
|
|||
Change in valuation allowance
|
|
(1,143
|
)
|
|
(7,425
|
)
|
|
(4,732
|
)
|
|||
Income tax deferred charge
|
|
938
|
|
|
980
|
|
|
15,273
|
|
|||
International tax rates differential
|
|
3,097
|
|
|
8,547
|
|
|
(6,023
|
)
|
|||
Nondeductible stock based compensation
|
|
1,436
|
|
|
1,004
|
|
|
693
|
|
|||
Cross-border merger
|
|
9,773
|
|
|
—
|
|
|
—
|
|
|||
Unrecognized tax benefit
|
|
1,475
|
|
|
290
|
|
|
—
|
|
|||
State and local taxes (net of federal)
|
|
934
|
|
|
1,170
|
|
|
(228
|
)
|
|||
Other
|
|
227
|
|
|
(3,784
|
)
|
|
2,060
|
|
|||
Income tax provision (benefit) - at effective income tax rate
|
|
$
|
31,558
|
|
|
$
|
35,907
|
|
|
$
|
(644
|
)
|
|
|
|
|
|
|
|
|
Increase / (Decrease)
|
|||||||||||||||||
|
|
Years Ended December 31,
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
|||||||||||||||||||
Net Income from Discontinued Operations
|
|
2016
|
|
2015
|
|
2014
|
|
$
|
|
%
|
|
$
|
|
%
|
|||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Net income from discontinued operations
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,018
|
|
|
$
|
—
|
|
|
n/a
|
|
$
|
(4,018
|
)
|
|
(100.0
|
)%
|
Net Income from Discontinued Operations
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
|
||||||
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
14,967
|
|
Operating income (loss)
|
|
—
|
|
|
—
|
|
|
(875
|
)
|
|||
Gain on disposal
|
|
—
|
|
|
—
|
|
|
5,007
|
|
|||
Interest expense
|
|
—
|
|
|
—
|
|
|
(4
|
)
|
|||
Income tax provision
|
|
—
|
|
|
—
|
|
|
(110
|
)
|
|||
Net income from discontinued operations
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,018
|
|
|
|
|
|
|
|
|
Increase / (Decrease)
|
||||||||||||||||||
|
Years Ended December 31,
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||||||||||||
Net Cash Provided By (Used In):
|
2016
|
|
2015
|
|
2014
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Operating activities
|
$
|
18,901
|
|
|
$
|
84,293
|
|
|
$
|
(10,617
|
)
|
|
$
|
(65,392
|
)
|
|
(77.6
|
)%
|
|
$
|
94,910
|
|
|
(893.9
|
)%
|
Investing activities
|
(36,630
|
)
|
|
(31,730
|
)
|
|
(43,083
|
)
|
|
(4,900
|
)
|
|
15.4
|
%
|
|
11,353
|
|
|
(26.4
|
)%
|
|||||
Financing activities
|
(7,954
|
)
|
|
(23,751
|
)
|
|
95,995
|
|
|
15,797
|
|
|
(66.5
|
)%
|
|
(119,746
|
)
|
|
(124.7
|
)%
|
Purchase Commitment:
|
|
Balance
|
||
|
|
|
||
2017
|
|
$
|
778
|
|
2018
|
|
1,032
|
|
|
2019
|
|
1,126
|
|
|
2020
|
|
1,126
|
|
|
2021
|
|
1,126
|
|
|
Thereafter
|
|
15,295
|
|
|
Total
|
|
$
|
20,483
|
|
Lease Commitment:
|
|
Balance
|
||
|
|
|
||
2017
|
|
$
|
1,117
|
|
2018
|
|
783
|
|
|
2019
|
|
717
|
|
|
2020
|
|
699
|
|
|
2021
|
|
441
|
|
|
Thereafter
|
|
600
|
|
|
Total
|
|
$
|
4,357
|
|
|
|
Payments Due by Period
|
||||||||||||||||||
Contractual Obligations:
|
|
Total
|
|
Less than
1 Year |
|
1 to 3
Years |
|
3 to 5
Years |
|
More than
5 Years |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Long-term debt
|
|
$
|
815
|
|
|
$
|
268
|
|
|
$
|
547
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Long-term related party payable (undiscounted)
|
|
278,236
|
|
|
35,226
|
|
|
57,466
|
|
|
60,587
|
|
|
124,957
|
|
|||||
Purchase commitments
|
|
41,721
|
|
|
12,266
|
|
|
11,908
|
|
|
2,252
|
|
|
15,295
|
|
|||||
Operating leases
|
|
4,982
|
|
|
1,390
|
|
|
1,837
|
|
|
1,155
|
|
|
600
|
|
|||||
Total contractual cash obligations
|
|
$
|
325,754
|
|
|
$
|
49,150
|
|
|
$
|
71,758
|
|
|
$
|
63,994
|
|
|
$
|
140,852
|
|
|
|
Years ended December 31,
|
||||||||||
|
|
2016
|
|
2015
|
|
2014
|
||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|||
Product sales and services
|
|
$
|
147,222
|
|
|
$
|
172,288
|
|
|
$
|
12,193
|
|
License and research revenue
|
|
3,024
|
|
|
721
|
|
|
2,782
|
|
|||
Total
|
|
150,246
|
|
|
173,009
|
|
|
14,975
|
|
|||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|||
Cost of products and services sold
|
|
13,248
|
|
|
11,410
|
|
|
3,383
|
|
|||
Research and development
|
|
34,611
|
|
|
25,608
|
|
|
17,298
|
|
|||
Selling, general and administrative
|
|
44,179
|
|
|
21,712
|
|
|
15,698
|
|
|||
Intangible asset amortization
|
|
13,888
|
|
|
12,564
|
|
|
11,749
|
|
|||
Changes in fair value of related party contingent consideration
|
|
49,285
|
|
|
30,957
|
|
|
57,491
|
|
|||
Loss on early repayment of related party acquisition-related note
|
|
—
|
|
|
—
|
|
|
3,013
|
|
|||
Total
|
|
155,211
|
|
|
102,251
|
|
|
108,632
|
|
|||
Operating income (loss)
|
|
(4,965
|
)
|
|
70,758
|
|
|
(93,657
|
)
|
|||
Investment and other income
|
|
1,635
|
|
|
1,236
|
|
|
927
|
|
|||
Interest expense
|
|
(963
|
)
|
|
—
|
|
|
(5,747
|
)
|
|||
Other expense - changes in fair value of related party payable
|
|
(6,548
|
)
|
|
(4,883
|
)
|
|
(3,525
|
)
|
|||
Foreign exchange gain
|
|
1,123
|
|
|
10,594
|
|
|
11,871
|
|
|||
Income (loss) before income taxes
|
|
(9,718
|
)
|
|
77,705
|
|
|
(90,131
|
)
|
|||
Income tax provision (benefit)
|
|
31,558
|
|
|
35,907
|
|
|
(644
|
)
|
|||
Net income (loss) from continuing operations
|
|
(41,276
|
)
|
|
41,798
|
|
|
(89,487
|
)
|
|||
Net income from discontinued operations
|
|
—
|
|
|
—
|
|
|
4,018
|
|
|||
Net income (loss)
|
|
$
|
(41,276
|
)
|
|
$
|
41,798
|
|
|
$
|
(85,469
|
)
|
|
|
|
|
|
|
|
||||||
Earnings (loss) per share - basic:
|
|
|
|
|
|
|
|
|
|
|||
Continuing operations
|
|
$
|
(1.00
|
)
|
|
$
|
1.03
|
|
|
$
|
(2.47
|
)
|
Discontinued operations
|
|
—
|
|
|
—
|
|
|
0.11
|
|
|||
Net income (loss)
|
|
$
|
(1.00
|
)
|
|
$
|
1.03
|
|
|
$
|
(2.36
|
)
|
|
|
|
|
|
|
|
||||||
Earnings (loss) per share - diluted:
|
|
|
|
|
|
|
|
|
|
|||
Continuing operations
|
|
$
|
(1.00
|
)
|
|
$
|
0.96
|
|
|
$
|
(2.47
|
)
|
Discontinued operations
|
|
—
|
|
|
—
|
|
|
0.11
|
|
|||
Net income (loss)
|
|
$
|
(1.00
|
)
|
|
$
|
0.96
|
|
|
$
|
(2.36
|
)
|
|
|
|
|
|
|
|
||||||
Weighted average number of shares outstanding - basic
|
|
41,248
|
|
|
40,580
|
|
|
36,214
|
|
|||
Weighted average number of shares outstanding - diluted
|
|
41,248
|
|
|
43,619
|
|
|
36,214
|
|
|
|
Years ended December 31,
|
||||||||||
|
|
2016
|
|
2015
|
|
2014
|
||||||
Net income (loss)
|
|
$
|
(41,276
|
)
|
|
$
|
41,798
|
|
|
$
|
(85,469
|
)
|
Other comprehensive income (loss), net of tax:
|
|
|
|
|
|
|
|
|
|
|||
Foreign currency translation loss
|
|
(1,024
|
)
|
|
(15,087
|
)
|
|
(18,040
|
)
|
|||
Net other comprehensive income (loss) on marketable securities, net of $16, ($20), ($0) tax, respectively
|
|
116
|
|
|
(147
|
)
|
|
(198
|
)
|
|||
Total other comprehensive loss, net of tax
|
|
(908
|
)
|
|
(15,234
|
)
|
|
(18,238
|
)
|
|||
Total comprehensive (loss) income
|
|
$
|
(42,184
|
)
|
|
$
|
26,564
|
|
|
$
|
(103,707
|
)
|
|
|
December 31,
|
||||||
|
|
2016
|
|
2015
|
||||
ASSETS
|
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
|
||
Cash and cash equivalents
|
|
$
|
39,215
|
|
|
$
|
65,064
|
|
Marketable securities
|
|
114,980
|
|
|
79,738
|
|
||
Accounts receivable
|
|
17,839
|
|
|
7,487
|
|
||
Inventories
|
|
3,258
|
|
|
3,666
|
|
||
Research and development tax credit receivable
|
|
—
|
|
|
2,382
|
|
||
Prepaid expenses and other current assets
|
|
5,894
|
|
|
8,064
|
|
||
Total current assets
|
|
181,186
|
|
|
166,401
|
|
||
Property and equipment, net
|
|
3,320
|
|
|
2,616
|
|
||
Goodwill
|
|
18,491
|
|
|
18,491
|
|
||
Intangible assets, net
|
|
22,837
|
|
|
15,825
|
|
||
Research and development tax credit receivable
|
|
1,775
|
|
|
—
|
|
||
Income tax deferred charge
|
|
10,342
|
|
|
11,581
|
|
||
Other
|
|
7,531
|
|
|
167
|
|
||
Total assets
|
|
$
|
245,482
|
|
|
$
|
215,081
|
|
|
|
|
|
|
||||
LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
|
||
Current portion of long-term debt
|
|
$
|
268
|
|
|
$
|
434
|
|
Current portion of long-term related party payable
|
|
34,177
|
|
|
25,204
|
|
||
Accounts payable
|
|
7,105
|
|
|
5,048
|
|
||
Deferred revenue
|
|
2,223
|
|
|
5,121
|
|
||
Accrued expenses
|
|
17,222
|
|
|
9,308
|
|
||
Income taxes
|
|
1,200
|
|
|
—
|
|
||
Other
|
|
226
|
|
|
133
|
|
||
Total current liabilities
|
|
62,421
|
|
|
45,248
|
|
||
Long-term debt
|
|
547
|
|
|
684
|
|
||
Long-term related party payable
|
|
135,170
|
|
|
97,489
|
|
||
Other
|
|
5,275
|
|
|
2,526
|
|
||
Total liabilities
|
|
203,413
|
|
|
145,947
|
|
||
|
|
|
|
|
||||
Shareholders' equity:
|
|
|
|
|
|
|
||
Preferred shares, $0.01 nominal value; 50,000 shares authorized at December 31, 2016, none authorized at December 31, 2015; none issued or outstanding at December 31, 2016 and December 31, 2015, respectively
|
|
—
|
|
|
—
|
|
||
Ordinary shares, nominal value of $0.01 and €0.122; 500,000 and 53,178 shares authorized; 41,371 and 41,241 issued and outstanding at December 31, 2016 and 2015, respectively
|
|
414
|
|
|
6,331
|
|
||
Additional paid-in capital
|
|
385,020
|
|
|
363,984
|
|
||
Accumulated deficit
|
|
(319,800
|
)
|
|
(278,524
|
)
|
||
Accumulated other comprehensive loss
|
|
(23,565
|
)
|
|
(22,657
|
)
|
||
Total shareholders' equity
|
|
42,069
|
|
|
69,134
|
|
||
Total liabilities and shareholders' equity
|
|
$
|
245,482
|
|
|
$
|
215,081
|
|
|
|
Ordinary shares
|
|
Additional
|
|
Accumulated
|
|
Accumulated
other
comprehensive
|
|
Total
shareholders'
|
|||||||||||||
|
|
Shares
|
|
Amount
|
|
paid-in capital
|
|
deficit
|
|
loss
|
|
equity
|
|||||||||||
Balance, December 31, 2013
|
|
25,613
|
|
|
$
|
3,746
|
|
|
$
|
211,473
|
|
|
$
|
(234,853
|
)
|
|
$
|
10,815
|
|
|
$
|
(8,819
|
)
|
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(85,469
|
)
|
|
—
|
|
|
(85,469
|
)
|
|||||
Other comprehensive loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(18,238
|
)
|
|
(18,238
|
)
|
|||||
Subscription of warrants
|
|
—
|
|
|
—
|
|
|
351
|
|
|
—
|
|
|
—
|
|
|
351
|
|
|||||
Exercise of stock options or warrants
|
|
1,001
|
|
|
164
|
|
|
5,861
|
|
|
—
|
|
|
—
|
|
|
6,025
|
|
|||||
Vesting of free shares
|
|
151
|
|
|
24
|
|
|
(24
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Stock-based compensation expense
|
|
—
|
|
|
—
|
|
|
2,894
|
|
|
—
|
|
|
—
|
|
|
2,894
|
|
|||||
Public offering
|
|
12,400
|
|
|
2,099
|
|
|
113,133
|
|
|
—
|
|
|
—
|
|
|
115,232
|
|
|||||
Shares granted to Recipharm AB
|
|
1,026
|
|
|
155
|
|
|
12,894
|
|
|
—
|
|
|
—
|
|
|
13,049
|
|
|||||
Balance, December 31, 2014
|
|
40,191
|
|
|
6,188
|
|
|
346,582
|
|
|
(320,322
|
)
|
|
(7,423
|
)
|
|
25,025
|
|
|||||
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
41,798
|
|
|
—
|
|
|
41,798
|
|
|||||
Other comprehensive loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(15,234
|
)
|
|
(15,234
|
)
|
|||||
Subscription of warrants
|
|
—
|
|
|
—
|
|
|
601
|
|
|
—
|
|
|
—
|
|
|
601
|
|
|||||
Exercise of stock options or warrants
|
|
899
|
|
|
123
|
|
|
6,266
|
|
|
—
|
|
|
—
|
|
|
6,389
|
|
|||||
Vesting of free shares
|
|
151
|
|
|
20
|
|
|
(20
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Stock-based compensation expense
|
|
—
|
|
|
—
|
|
|
7,741
|
|
|
—
|
|
|
—
|
|
|
7,741
|
|
|||||
Excess tax benefit from stock-based compensation
|
|
—
|
|
|
—
|
|
|
2,814
|
|
|
—
|
|
|
—
|
|
|
2,814
|
|
|||||
Balance, December 31, 2015
|
|
41,241
|
|
|
6,331
|
|
|
363,984
|
|
|
(278,524
|
)
|
|
(22,657
|
)
|
|
69,134
|
|
|||||
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(41,276
|
)
|
|
—
|
|
|
(41,276
|
)
|
|||||
Other comprehensive loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(908
|
)
|
|
(908
|
)
|
|||||
Subscription of warrants
|
|
—
|
|
|
—
|
|
|
326
|
|
|
—
|
|
|
—
|
|
|
326
|
|
|||||
Exercise of stock options
|
|
15
|
|
|
2
|
|
|
112
|
|
|
—
|
|
|
—
|
|
|
114
|
|
|||||
Vesting of free shares
|
|
115
|
|
|
18
|
|
|
(18
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Stock-based compensation expense
|
|
—
|
|
|
—
|
|
|
14,679
|
|
|
—
|
|
|
—
|
|
|
14,679
|
|
|||||
Cross-border merger nominal value adjustment
|
|
—
|
|
|
(5,937
|
)
|
|
5,937
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Balance, December 31, 2016
|
|
41,371
|
|
|
$
|
414
|
|
|
$
|
385,020
|
|
|
$
|
(319,800
|
)
|
|
$
|
(23,565
|
)
|
|
$
|
42,069
|
|
|
|
Years ended December 31,
|
||||||||||
|
|
2016
|
|
2015
|
|
2014
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|||
Net income (loss)
|
|
$
|
(41,276
|
)
|
|
$
|
41,798
|
|
|
$
|
(85,469
|
)
|
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
|
|
|
|
|
|
|
|
|
|
|||
Depreciation and amortization
|
|
14,489
|
|
|
13,132
|
|
|
14,141
|
|
|||
Loss (gain) on disposal of property and equipment
|
|
110
|
|
|
—
|
|
|
(4,952
|
)
|
|||
Loss on sale of marketable securities
|
|
826
|
|
|
779
|
|
|
—
|
|
|||
Unrealized foreign currency exchange gain
|
|
(349
|
)
|
|
(8,969
|
)
|
|
(6,252
|
)
|
|||
Gains on waiver of research and development grants and other
|
|
—
|
|
|
(1,498
|
)
|
|
(589
|
)
|
|||
Remeasurement of related party acquisition-related contingent consideration
|
|
49,285
|
|
|
30,957
|
|
|
60,503
|
|
|||
Remeasurement of related party financing-related royalty agreements
|
|
6,548
|
|
|
4,883
|
|
|
3,319
|
|
|||
Change in deferred tax and income tax deferred charge
|
|
(4,000
|
)
|
|
69
|
|
|
(2,113
|
)
|
|||
Stock-based compensation expense
|
|
14,679
|
|
|
7,741
|
|
|
2,690
|
|
|||
Increase (decrease) in cash from:
|
|
|
|
|
|
|
|
|
|
|||
Accounts receivable
|
|
(10,050
|
)
|
|
(8,440
|
)
|
|
3,249
|
|
|||
Inventories
|
|
1,831
|
|
|
3,036
|
|
|
(3,112
|
)
|
|||
Prepaid expenses and other current assets
|
|
3,412
|
|
|
(684
|
)
|
|
(2,329
|
)
|
|||
Research and development tax credit receivable
|
|
397
|
|
|
2,975
|
|
|
13,210
|
|
|||
Accounts payable & other current liabilities
|
|
(434
|
)
|
|
(8,533
|
)
|
|
7,219
|
|
|||
Deferred revenue
|
|
(2,923
|
)
|
|
3,815
|
|
|
(55
|
)
|
|||
Accrued expenses
|
|
6,764
|
|
|
3,376
|
|
|
452
|
|
|||
Accrued income taxes
|
|
1,778
|
|
|
(393
|
)
|
|
70
|
|
|||
Earn-out payments for related party contingent consideration in excess of acquisition-date fair value
|
|
(20,252
|
)
|
|
—
|
|
|
—
|
|
|||
Royalty payments for related party payable in excess of original fair value
|
|
(2,469
|
)
|
|
—
|
|
|
—
|
|
|||
Other long-term assets and liabilities
|
|
535
|
|
|
249
|
|
|
(10,599
|
)
|
|||
Net cash provided by (used in) operating activities
|
|
18,901
|
|
|
84,293
|
|
|
(10,617
|
)
|
|||
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|||
Purchases of property and equipment
|
|
(1,201
|
)
|
|
(1,629
|
)
|
|
(1,728
|
)
|
|||
Proceeds from disposal of property and equipment
|
|
—
|
|
|
—
|
|
|
13,242
|
|
|||
Acquisitions of businesses, including cash acquired and other adjustments
|
|
628
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from sales of marketable securities
|
|
71,546
|
|
|
48,308
|
|
|
24,993
|
|
|||
Purchases of marketable securities
|
|
(107,603
|
)
|
|
(78,409
|
)
|
|
(79,590
|
)
|
|||
Net cash used in investing activities
|
|
(36,630
|
)
|
|
(31,730
|
)
|
|
(43,083
|
)
|
|||
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|||
Reimbursement of loans
|
|
—
|
|
|
(4,911
|
)
|
|
(34,186
|
)
|
|||
Reimbursement of conditional R&D grants
|
|
(277
|
)
|
|
(747
|
)
|
|
(355
|
)
|
|||
Principal payments on capital lease obligations
|
|
—
|
|
|
—
|
|
|
(161
|
)
|
|||
Earn-out payments for related party contingent consideration
|
|
(6,892
|
)
|
|
(24,526
|
)
|
|
(1,357
|
)
|
|||
Royalty payments for related party payable
|
|
(1,225
|
)
|
|
(3,371
|
)
|
|
(206
|
)
|
|||
Excess tax benefit from stock-based compensation
|
|
—
|
|
|
2,814
|
|
|
—
|
|
|||
Cash proceeds from issuance of ordinary shares and warrants
|
|
440
|
|
|
6,990
|
|
|
132,260
|
|
|||
Net cash provided by (used in) financing activities
|
|
(7,954
|
)
|
|
(23,751
|
)
|
|
95,995
|
|
|||
Effect of exchange rate changes on cash and cash equivalents
|
|
(166
|
)
|
|
(3,508
|
)
|
|
(9,171
|
)
|
|||
Net increase (decrease) in cash and cash equivalents
|
|
(25,849
|
)
|
|
25,304
|
|
|
33,124
|
|
|||
Cash and cash equivalents at January 1
|
|
65,064
|
|
|
39,760
|
|
|
6,636
|
|
|||
Cash and cash equivalents at December 31
|
|
$
|
39,215
|
|
|
$
|
65,064
|
|
|
$
|
39,760
|
|
Supplemental disclosures of cash flow information:
|
|
|
|
|
|
|
|
|
|
|||
Income tax paid
|
|
$
|
27,180
|
|
|
$
|
42,121
|
|
|
$
|
403
|
|
Interest paid
|
|
788
|
|
|
4,738
|
|
|
4,431
|
|
•
|
the development of differentiated, patent protected products through application of the Company’s proprietary patented drug delivery platforms, Micropump® and LiquiTime®, that target high-value solid and liquid oral and alternative dosages forms through the U.S. Food and Drug Administration (FDA) 505(b)(2) approval process, which allows a sponsor to submit an application that doesn’t depend on efficacy, safety, and toxicity data created by the sponsor. In addition to Micropump® and LiquiTime®, the Company has two other proprietary drug delivery platforms, Medusa™ (hydrogel depot technology for use with large molecules and peptides) and Trigger Lock™ (controlled release of opioid analgesics with potential abuse deterrent properties).
|
•
|
the identification of Unapproved Marketed Drugs (“UMDs”), which are currently sold in the U.S., but unapproved by the FDA, and the pursuit of approval for these products via a 505(b)(2) New Drug Application (NDA). To date, the Company has received approvals through this “unapproved-to-approved” avenue for three products: Bloxiverz® (neostigmine methylsulfate injection), Vazculep® (phenylephrine hydrochloride injection) and Akovaz® (ephedrine sulfate injection). As a potential source of near-term revenue growth, Avadel is working on the development of a fourth product for potential NDA submission by year-end 2017, and seeks to identify additional product candidates for development with this strategy.
|
•
|
the acquisition of commercial and or late-stage products or businesses. The Company markets three branded pediatric-focused pharmaceutical products in the primary care space, and a 510(k) approved device that will launch in the second quarter of 2017, all of which were purchased through the acquisition of FSC Laboratories and FSC Pediatrics on February 5, 2016. We will consider further acquisitions, and the Company continues to look for assets that could fit strategically into its current or potential future commercial sales force.
|
•
|
Flamel ceased to exist as a separate entity and the Company continued as the surviving entity and assumed all of the assets and liabilities of Flamel.
|
•
|
our authorized share capital is $5,500 divided into
500,000
ordinary shares with a nominal value of
$0.01
each and
50,000
preferred shares with a nominal value of
$0.01
each
|
◦
|
all outstanding ordinary shares of Flamel,
€0.122
nominal value per share, were canceled and exchanged on a one-for-one basis for newly issued ordinary shares of the Company,
$0.01
nominal value per share. This change in nominal value of our outstanding shares resulted in our reclassifying
$5,937
on our balance sheet from ordinary shares to additional paid-in capital
|
◦
|
our board of directors is authorized to issue preferred shares on a non-pre-emptive basis, for a maximum period of five years, at which point it may be renewed by shareholders. The board of directors has discretion to dictate terms attached to the preferred shares, including voting, dividend, conversion rights, and priority relative to other classes of shares with respect to dividends and upon a liquidation.
|
•
|
all outstanding American Depositary Shares (ADSs) representing ordinary shares of Flamel were canceled and exchanged on a one-for-one basis for ADSs representing ordinary shares of the Company.
|
|
|
Twelve Months Ended December 31, 2014
|
||||||||||||||
|
|
|
|
Correction of Immaterial Errors
|
|
|
||||||||||
Consolidated Statement of Loss:
|
|
As filed
|
|
(b)
|
|
(f)
|
|
As revised
|
||||||||
|
|
|
|
|
|
|
|
|
||||||||
Product sales and services
|
|
$
|
11,993
|
|
|
$
|
200
|
|
|
$
|
—
|
|
|
$
|
12,193
|
|
Total revenue
|
|
14,775
|
|
|
200
|
|
|
—
|
|
|
14,975
|
|
||||
Operating income (loss)
|
|
(93,857
|
)
|
|
200
|
|
|
—
|
|
|
(93,657
|
)
|
||||
Income (loss) before income taxes
|
|
(90,331
|
)
|
|
200
|
|
|
—
|
|
|
(90,131
|
)
|
||||
Income tax provision (benefit)
|
|
(1,407
|
)
|
|
70
|
|
|
693
|
|
|
(644
|
)
|
||||
Net income (loss) from continuing operations
|
|
(88,924
|
)
|
|
130
|
|
|
(693
|
)
|
|
(89,487
|
)
|
||||
Net income (loss)
|
|
(84,906
|
)
|
|
130
|
|
|
(693
|
)
|
|
(85,469
|
)
|
||||
Net loss per share - basic
|
|
$
|
(2.34
|
)
|
|
$
|
—
|
|
|
$
|
(0.02
|
)
|
|
$
|
(2.36
|
)
|
Net loss per share - diluted
|
|
$
|
(2.34
|
)
|
|
$
|
—
|
|
|
$
|
(0.02
|
)
|
|
$
|
(2.36
|
)
|
|
|
Twelve Months Ended December 31, 2015
|
||||||||||||||||||
|
|
|
|
Correction of Immaterial Errors
|
|
|
||||||||||||||
Consolidated Statement of Income:
|
|
As filed
|
|
(a)
|
|
(b)
|
|
(c)
|
|
As revised
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Product sales and services
|
|
$
|
172,488
|
|
|
$
|
—
|
|
|
$
|
(200
|
)
|
|
$
|
—
|
|
|
$
|
172,288
|
|
Total revenue
|
|
173,209
|
|
|
—
|
|
|
(200
|
)
|
|
—
|
|
|
173,009
|
|
|||||
Cost of products and services sold
|
|
10,921
|
|
|
—
|
|
|
—
|
|
|
489
|
|
|
11,410
|
|
|||||
Total operating expenses
|
|
101,762
|
|
|
—
|
|
|
—
|
|
|
489
|
|
|
102,251
|
|
|||||
Operating income (loss)
|
|
71,447
|
|
|
—
|
|
|
(200
|
)
|
|
(489
|
)
|
|
70,758
|
|
|||||
Income (loss) before income taxes
|
|
78,394
|
|
|
—
|
|
|
(200
|
)
|
|
(489
|
)
|
|
77,705
|
|
|||||
Income tax provision (benefit)
|
|
37,735
|
|
|
(1,587
|
)
|
|
(70
|
)
|
|
(171
|
)
|
|
35,907
|
|
|||||
Net income (loss) from continuing operations
|
|
40,659
|
|
|
1,587
|
|
|
(130
|
)
|
|
(318
|
)
|
|
41,798
|
|
|||||
Net income (loss)
|
|
40,659
|
|
|
1,587
|
|
|
(130
|
)
|
|
(318
|
)
|
|
41,798
|
|
|||||
Net income (loss) per share - basic
|
|
$
|
1.00
|
|
|
$
|
0.04
|
|
|
$
|
—
|
|
|
$
|
(0.01
|
)
|
|
1.03
|
|
|
Net income (loss) per share - diluted
|
|
$
|
0.93
|
|
|
$
|
0.04
|
|
|
$
|
—
|
|
|
$
|
(0.01
|
)
|
|
$
|
0.96
|
|
|
|
December 31, 2015
|
||||||||||||||||||||||||||
|
|
|
|
Correction of Immaterial Errors
|
|
Reclassifications
|
|
|
||||||||||||||||||||
Consolidated Balance Sheet:
|
|
As filed
|
|
(a)
|
|
(c)
|
|
(d)
|
|
(e)
|
|
(g)
|
|
As revised
|
||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Accounts receivable
|
|
$
|
6,978
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
509
|
|
|
$
|
—
|
|
|
$
|
7,487
|
|
Inventories
|
|
4,155
|
|
|
—
|
|
|
(489
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,666
|
|
|||||||
Prepaid expenses and other current assets
|
|
7,989
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
75
|
|
|
8,064
|
|
|||||||
Total current assets
|
|
166,306
|
|
|
—
|
|
|
(489
|
)
|
|
—
|
|
|
509
|
|
|
75
|
|
|
166,401
|
|
|||||||
Other
|
|
158
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
9
|
|
|
167
|
|
|||||||
Total assets
|
|
214,977
|
|
|
—
|
|
|
(489
|
)
|
|
—
|
|
|
509
|
|
|
84
|
|
|
215,081
|
|
|||||||
Current portion of long-term related party payable
|
|
28,614
|
|
|
—
|
|
|
—
|
|
|
(3,410
|
)
|
|
—
|
|
|
—
|
|
|
25,204
|
|
|||||||
Accounts payable
|
|
10,565
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(5,517
|
)
|
|
—
|
|
|
5,048
|
|
|||||||
Accrued expenses
|
|
3,598
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,710
|
|
|
—
|
|
|
9,308
|
|
|||||||
Income taxes
|
|
323
|
|
|
(228
|
)
|
|
(171
|
)
|
|
—
|
|
|
—
|
|
|
76
|
|
|
—
|
|
|||||||
Total current liabilities
|
|
48,788
|
|
|
(228
|
)
|
|
(171
|
)
|
|
(3,410
|
)
|
|
193
|
|
|
76
|
|
|
45,248
|
|
|||||||
Long-term related party payable
|
|
94,079
|
|
|
—
|
|
|
—
|
|
|
3,410
|
|
|
—
|
|
|
—
|
|
|
97,489
|
|
|||||||
Deferred taxes
|
|
1,351
|
|
|
(1,359
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
8
|
|
|
—
|
|
|||||||
Other
|
|
2,210
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
316
|
|
|
—
|
|
|
2,526
|
|
|||||||
Total liabilities
|
|
147,112
|
|
|
(1,587
|
)
|
|
(171
|
)
|
|
—
|
|
|
509
|
|
|
84
|
|
|
145,947
|
|
|||||||
Accumulated deficit
|
|
(279,793
|
)
|
|
1,587
|
|
|
(318
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(278,524
|
)
|
|||||||
Total shareholders' equity
|
|
67,865
|
|
|
1,587
|
|
|
(318
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
69,134
|
|
|||||||
Total liabilities and shareholders' equity
|
|
214,977
|
|
|
—
|
|
|
(489
|
)
|
|
—
|
|
|
509
|
|
|
84
|
|
|
215,081
|
|
(a)
|
Reflects the cumulative 2015 correction of
$1,587
of income tax benefits related to the deductibility of the U.S. Internal Revenue Code Section 483 imputed interest on contingent consideration liabilities which should have been recorded in prior periods (
$866
,
$292
,
$863
and (
$434
) in the first, second, third and fourth quarters of 2015, respectively).
|
(b)
|
Reflects the correction of a
$200
overstatement of revenue in the first quarter of 2015 resulting from errors in certain estimates of ending inventory amounts at our wholesalers which were originally corrected in the first quarter of 2015 but should have been recorded in the fourth quarter of 2014. As this item was originally corrected in the first quarter of 2015, no adjustment was required to correct the consolidated balance sheet at December 31, 2015.
|
(c)
|
Reflects the correction of a
$489
error in the Company’s inventory obsolescence reserve accrual and expense which was originally recorded in the first quarter of 2016 but should have been recorded in the fourth quarter of 2015.
|
(d)
|
Reflects the correction of a balance sheet classification error which overstated the current portion of the long-term related party payable by
$3,410
.
|
(e)
|
Reflects revisions to the presentation of certain gross to net revenue reserves which were previously included in accounts payable and are now included in accrued expenses.
|
(f)
|
Reflects the correction of
$2,606
of income tax benefits from stock-based compensation and certain other items which were originally recorded in the fourth quarter of 2015 but should have been recorded in prior periods (
$360
in 2012,
$333
in 2013, $(
693
) in 2014, and $
830
,
$1,026
and
$750
in the first, second and third quarters of 2015, respectively). As these items were originally corrected in the fourth quarter of 2015, no adjustment was required to correct the consolidated balance sheet at December 31, 2015.
|
(g)
|
Reflects balance sheet reclassifications required to properly net the accrued income tax and deferred income tax amounts within the balance sheet as a result of the adjustments made in items (a) through (f) above.
|
Laboratory equipment
|
4-8 years
|
Office and computer equipment
|
3 years
|
Leasehold improvements, furniture, fixtures and fittings
|
5-10 years
|
•
|
Income approach, which is based on the present value of a future stream of net cash flows.
|
•
|
Market approach, which is based on market prices and other information from market transactions involving identical or comparable assets or liabilities.
|
•
|
Level 1 - Quoted prices for identical assets or liabilities in active markets.
|
•
|
Level 2 - Quoted prices for similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs other than quoted prices that are directly or indirectly observable, or inputs that are derived principally from, or corroborated by, observable market data by correlation or other means.
|
•
|
Level 3 - Unobservable inputs that reflect estimates and assumptions.
|
|
|
As of December 31, 2016
|
|
As of December 31, 2015
|
||||||||||||||||||||
Fair Value Measurements:
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Marketable securities (see Note 4)
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Equity securities
|
|
$
|
4,033
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,525
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Time deposits
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
13,641
|
|
|
—
|
|
||||||
Corporate bonds
|
|
—
|
|
|
57,348
|
|
|
—
|
|
|
—
|
|
|
42,139
|
|
|
—
|
|
||||||
Government securities - U.S.
|
|
—
|
|
|
42,814
|
|
|
—
|
|
|
—
|
|
|
13,738
|
|
|
—
|
|
||||||
Government securities - Non-U.S.
|
|
—
|
|
|
233
|
|
|
—
|
|
|
—
|
|
|
1,063
|
|
|
—
|
|
||||||
Other fixed-income securities
|
|
—
|
|
|
10,471
|
|
|
—
|
|
|
—
|
|
|
3,992
|
|
|
—
|
|
||||||
Other securities
|
|
—
|
|
|
81
|
|
|
—
|
|
|
—
|
|
|
1,640
|
|
|
—
|
|
||||||
Total assets
|
|
$
|
4,033
|
|
|
$
|
110,947
|
|
|
$
|
—
|
|
|
$
|
3,525
|
|
|
$
|
76,213
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Related party payable (see Note 10)
|
|
—
|
|
|
—
|
|
|
169,347
|
|
|
—
|
|
|
—
|
|
|
122,693
|
|
||||||
Total liabilities
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
169,347
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
122,693
|
|
|
|
2016
|
||||||||||||||
Marketable Securities:
|
|
Adjusted Cost
|
|
Unrealized Gains
|
|
Unrealized Losses
|
|
Fair Value
|
||||||||
|
|
|
|
|
|
|
|
|
||||||||
Equity securities
|
|
$
|
3,689
|
|
|
$
|
409
|
|
|
$
|
(65
|
)
|
|
$
|
4,033
|
|
Corporate bonds
|
|
57,871
|
|
|
89
|
|
|
(612
|
)
|
|
57,348
|
|
||||
Government securities - U.S.
|
|
43,049
|
|
|
515
|
|
|
(750
|
)
|
|
42,814
|
|
||||
Government securities - Non-U.S.
|
|
247
|
|
|
—
|
|
|
(14
|
)
|
|
233
|
|
||||
Other fixed-income securities
|
|
10,281
|
|
|
221
|
|
|
(31
|
)
|
|
10,471
|
|
||||
Other securities
|
|
81
|
|
|
—
|
|
|
—
|
|
|
81
|
|
||||
Total
|
|
$
|
115,218
|
|
|
$
|
1,234
|
|
|
$
|
(1,472
|
)
|
|
$
|
114,980
|
|
|
|
2015
|
||||||||||||||
Marketable Securities:
|
|
Adjusted Cost
|
|
Unrealized Gains
|
|
Unrealized Losses
|
|
Fair Value
|
||||||||
|
|
|
|
|
|
|
|
|
||||||||
Equity securities
|
|
$
|
3,510
|
|
|
$
|
29
|
|
|
$
|
(14
|
)
|
|
$
|
3,525
|
|
Time deposits
|
|
13,641
|
|
|
—
|
|
|
—
|
|
|
13,641
|
|
||||
Corporate bonds
|
|
42,129
|
|
|
1,520
|
|
|
(1,510
|
)
|
|
42,139
|
|
||||
Government securities - U.S.
|
|
13,822
|
|
|
4
|
|
|
(88
|
)
|
|
13,738
|
|
||||
Government securities - Non-U.S.
|
|
1,112
|
|
|
8
|
|
|
(57
|
)
|
|
1,063
|
|
||||
Other fixed-income securities
|
|
4,008
|
|
|
—
|
|
|
(16
|
)
|
|
3,992
|
|
||||
Other securities
|
|
1,663
|
|
|
—
|
|
|
(23
|
)
|
|
1,640
|
|
||||
Total
|
|
$
|
79,885
|
|
|
$
|
1,561
|
|
|
$
|
(1,708
|
)
|
|
$
|
79,738
|
|
|
|
Maturities
|
||||||||||||||||||
Marketable Securities:
|
|
Less than 1 Year
|
|
1-5 Years
|
|
5-10 Years
|
|
Greater than 10 Years
|
|
Total
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Equity securities
|
|
$
|
4,033
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,033
|
|
Corporate bonds
|
|
11,933
|
|
|
39,325
|
|
|
5,655
|
|
|
435
|
|
|
57,348
|
|
|||||
Government securities - U.S.
|
|
2,258
|
|
|
33,270
|
|
|
1,530
|
|
|
5,756
|
|
|
42,814
|
|
|||||
Government securities - Non-U.S.
|
|
—
|
|
|
—
|
|
|
233
|
|
|
—
|
|
|
233
|
|
|||||
Other fixed-income securities
|
|
—
|
|
|
8,199
|
|
|
1,996
|
|
|
276
|
|
|
10,471
|
|
|||||
Other securities
|
|
81
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
81
|
|
|||||
Total
|
|
$
|
18,305
|
|
|
$
|
80,794
|
|
|
$
|
9,414
|
|
|
$
|
6,467
|
|
|
$
|
114,980
|
|
Inventory:
|
|
2016
|
|
2015
|
||||
|
|
|
|
|
||||
Finished goods
|
|
$
|
2,429
|
|
|
$
|
2,545
|
|
Raw materials
|
|
829
|
|
|
1,121
|
|
||
Total
|
|
$
|
3,258
|
|
|
$
|
3,666
|
|
Property and Equipment, net:
|
|
2016
|
|
2015
|
||||
|
|
|
|
|
||||
Laboratory equipment
|
|
$
|
9,019
|
|
|
$
|
9,963
|
|
Office and computer equipment
|
|
2,519
|
|
|
2,968
|
|
||
Furniture, fixtures and fittings
|
|
4,239
|
|
|
4,315
|
|
||
Less - accumulated depreciation
|
|
(12,457
|
)
|
|
(14,630
|
)
|
||
Total
|
|
$
|
3,320
|
|
|
$
|
2,616
|
|
•
|
$15,000
long-term liability to Deerfield. Under the terms of the acquisition agreement, the Company will pay
$1,050
annually for
five
years with a final payment in January 2021 of
$15,000
.
|
•
|
an estimate of $
6,659
in contingent consideration to Deerfield. Under the terms of the acquisition agreement, the Company shall pay quarterly a
15%
royalty on the net sales of certain FSC products, up to
$12,500
for a period not exceeding
ten
years.
|
|
|
2016
|
||
Assigned Fair Value:
|
|
Final
|
||
|
|
|
||
Accounts receivable
|
|
$
|
142
|
|
Inventories
|
|
1,135
|
|
|
Prepaid expenses and other current assets
|
|
1,712
|
|
|
Intangible assets:
|
|
|
|
|
Acquired product marketing rights
|
|
16,600
|
|
|
Acquired developed technology
|
|
4,300
|
|
|
Deferred tax assets
|
|
853
|
|
|
Other assets
|
|
277
|
|
|
Accounts payable and other liabilities
|
|
(3,827
|
)
|
|
Total
|
|
$
|
21,192
|
|
Pro Forma Net Revenue and Income (Losses):
|
|
2016
|
|
2015
|
||||
|
|
|
|
|
||||
Net revenues
|
|
$
|
150,721
|
|
|
$
|
178,104
|
|
Net income (loss)
|
|
(42,290
|
)
|
|
30,965
|
|
|
|
2016
|
|
2015
|
||||||||||||||||||||
Goodwill and Intangible Assets:
|
|
Gross
Value
|
|
Accumulated
Amortization
|
|
Net Book
Value
|
|
Gross
Value
|
|
Accumulated
Amortization
|
|
Net Book
Value
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Amortizable intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Acquired IPR&D - Bloxiverz
|
|
$
|
35,248
|
|
|
$
|
(35,248
|
)
|
|
$
|
—
|
|
|
$
|
35,248
|
|
|
$
|
(23,498
|
)
|
|
$
|
11,750
|
|
Acquired IPR&D - Vazculep
|
|
12,061
|
|
|
(8,801
|
)
|
|
3,260
|
|
|
12,061
|
|
|
(7,986
|
)
|
|
4,075
|
|
||||||
Acquired product marketing rights
|
|
16,600
|
|
|
(1,019
|
)
|
|
15,581
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Acquired developed technology
|
|
4,300
|
|
|
(304
|
)
|
|
3,996
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Total amortizable intangible assets
|
|
$
|
68,209
|
|
|
$
|
(45,372
|
)
|
|
$
|
22,837
|
|
|
$
|
47,309
|
|
|
$
|
(31,484
|
)
|
|
$
|
15,825
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Unamortizable intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Goodwill
|
|
$
|
18,491
|
|
|
$
|
—
|
|
|
$
|
18,491
|
|
|
$
|
18,491
|
|
|
$
|
—
|
|
|
$
|
18,491
|
|
Total unamortizable intangible assets
|
|
$
|
18,491
|
|
|
$
|
—
|
|
|
$
|
18,491
|
|
|
$
|
18,491
|
|
|
$
|
—
|
|
|
$
|
18,491
|
|
|
|
|
|
Activity during the Twelve Months Ended December 31, 2016
|
|
|
||||||||||||||||||
|
|
|
|
|
|
|
|
Changes in Fair Value of
Related Party Payable
|
|
|
||||||||||||||
|
|
Balance,
December 31, 2015
|
|
Additions
|
|
Payments to
Related Parties
|
|
Operating
Expense
|
|
Other
Expense
|
|
Balance,
December 31, 2016 |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Acquisition-related:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Warrants - Éclat Pharmaceuticals
(a)
|
|
$
|
20,617
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(9,400
|
)
|
|
$
|
—
|
|
|
$
|
11,217
|
|
Earn-out payments - Éclat Pharmaceuticals
(b)
|
|
90,468
|
|
|
—
|
|
|
(26,700
|
)
|
|
57,609
|
|
|
—
|
|
|
121,377
|
|
||||||
Royalty agreement - FSC
(c)
|
|
—
|
|
|
6,659
|
|
|
(444
|
)
|
|
1,076
|
|
|
—
|
|
|
7,291
|
|
||||||
Financing-related:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
—
|
|
||||||
Royalty agreement - Deerfield
(d)
|
|
7,862
|
|
|
—
|
|
|
(2,501
|
)
|
|
—
|
|
|
4,433
|
|
|
9,794
|
|
||||||
Royalty agreement - Broadfin
(e)
|
|
3,746
|
|
|
—
|
|
|
(1,193
|
)
|
|
—
|
|
|
2,115
|
|
|
4,668
|
|
||||||
Long-term liability - FSC
(f)
|
|
—
|
|
|
15,000
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
15,000
|
|
||||||
Total related party payable
|
|
122,693
|
|
|
$
|
21,659
|
|
|
$
|
(30,838
|
)
|
|
$
|
49,285
|
|
|
$
|
6,548
|
|
|
169,347
|
|
||
Less: current portion
|
|
(25,204
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(34,177
|
)
|
||||||
Total long-term related party payable
|
|
$
|
97,489
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
135,170
|
|
(a)
|
As part of the consideration for the Company’s acquisition of Éclat Pharmaceuticals, LLC on March 13, 2012, the Company issued
two
warrants with a
six
-year term which allow for the purchase of a combined total of
3,300
ordinary shares of Avadel. One warrant is exercisable for
2,200
ordinary shares at an exercise price of
$7.44
per share, and the other warrant is exercisable for
1,100
ordinary shares at an exercise price of
$11.00
per share.
|
Warrant Assumptions:
|
|
2016
|
|
2015
|
||||
|
|
|
|
|
||||
Weighted average exercise price per share
|
|
$
|
8.63
|
|
|
$
|
8.63
|
|
Expected term (years)
|
|
1.25
|
|
|
2.25
|
|
||
Expected volatility
|
|
54.20
|
%
|
|
64.54
|
%
|
||
Risk-free interest rate
|
|
0.94
|
%
|
|
0.93
|
%
|
||
Expected dividend yield
|
|
—
|
|
|
—
|
|
(b)
|
In March 2012, the Company acquired all of the membership interests of Éclat from Breaking Stick Holdings, L.L.C. (“Breaking Stick”, formerly Éclat Holdings), an affiliate of Deerfield. Breaking Stick is majority owned by Deerfield, with a minority interest owned by Mr. Michael Anderson, the Company’s CEO, and certain other current and former employees. As part of the consideration, the Company committed to provide quarterly earn-out payments equal to
20%
of any gross profit generated by certain Éclat products. These payments will continue in perpetuity, to the extent gross profit of the related products also continue in perpetuity.
|
(c)
|
In February 2016, the Company acquired all of the membership interests of FSC from Deerfield. The consideration for this transaction in part included a commitment to pay quarterly a
15%
royalty on the net sales of certain FSC products, up to
$12,500
for a period not exceeding
ten
years.
|
(d)
|
As part of a February 2013 debt financing transaction conducted with Deerfield, the Company received cash of
$2,600
in exchange for entering into a royalty agreement whereby the Company shall pay quarterly a
1.75%
royalty on the net sales of certain Éclat products until December 31, 2024.
|
(e)
|
As part of a December 2013 debt financing transaction conducted with Broadfin Healthcare Master Fund, a related party and current shareholder, the Company received cash of
$2,200
in exchange for entering into a royalty agreement whereby the Company shall pay quarterly a
0.834%
royalty on the net sales of certain Éclat products until December 31, 2024.
|
(f)
|
In February 2016, the Company acquired all of the membership interests of FSC from Deerfield. The consideration for this transaction in part consists of payments totaling
$1,050
annually for
five
years with a final payment in January 2021 of
$15,000
. Substantially all of FSC's, and its subsidiaries, assets are pledged as collateral under this agreement.
|
Related Party Payable:
|
|
Balance
|
|
|
|
|
|
Balance at December 31, 2013
|
|
65,670
|
|
Payment of related party payable
|
|
(11,936
|
)
|
Fair value adjustments
(1)
|
|
61,016
|
|
Balance at December 31, 2014
|
|
114,750
|
|
Payment of related party payable
|
|
(27,897
|
)
|
Fair value adjustments
(1)
|
|
35,840
|
|
Balance at December 31, 2015
|
|
122,693
|
|
Additions
(2)
|
|
21,659
|
|
Payment of related party payable
|
|
(30,838
|
)
|
Fair value adjustments
(1)
|
|
55,833
|
|
Balance at December 31, 2016
|
|
169,347
|
|
Income (Loss) Before Income Taxes:
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
|
||||||
Ireland
|
|
$
|
(22,866
|
)
|
|
$
|
(29,469
|
)
|
|
$
|
—
|
|
United States
|
|
32,786
|
|
|
100,552
|
|
|
(89,739
|
)
|
|||
France
|
|
(19,638
|
)
|
|
6,622
|
|
|
(392
|
)
|
|||
Total income (loss) before income taxes
|
|
$
|
(9,718
|
)
|
|
$
|
77,705
|
|
|
$
|
(90,131
|
)
|
Income Tax Provision (Benefit):
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
|
||||||
Current:
|
|
|
|
|
|
|
|
|
|
|||
United States - Federal
|
|
$
|
30,738
|
|
|
$
|
33,289
|
|
|
$
|
—
|
|
United States - State
|
|
1,081
|
|
|
970
|
|
|
—
|
|
|||
France
|
|
5,267
|
|
|
1,657
|
|
|
1,400
|
|
|||
Total current
|
|
37,086
|
|
|
35,916
|
|
|
1,400
|
|
|||
|
|
|
|
|
|
|
||||||
Deferred:
|
|
|
|
|
|
|
|
|
|
|||
United States - Federal
|
|
(6,443
|
)
|
|
504
|
|
|
(1,713
|
)
|
|||
United States - State
|
|
(23
|
)
|
|
1,234
|
|
|
(331
|
)
|
|||
France
|
|
938
|
|
|
(1,747
|
)
|
|
—
|
|
|||
Total deferred
|
|
(5,528
|
)
|
|
(9
|
)
|
|
(2,044
|
)
|
|||
|
|
|
|
|
|
|
||||||
Income tax provision (benefit)
|
|
$
|
31,558
|
|
|
$
|
35,907
|
|
|
$
|
(644
|
)
|
Reconciliation to Effective Income Tax Rate:
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
|
||||||
Statutory tax rate
(1)
|
|
12.5
|
%
|
|
33.3
|
%
|
|
33.3
|
%
|
|||
Non-deductible changes in fair value of contingent consideration
|
|
(165.0
|
)%
|
|
11.9
|
%
|
|
(24.8
|
)%
|
|||
Change in valuation allowance
|
|
11.8
|
%
|
|
(9.6
|
)%
|
|
5.3
|
%
|
|||
Income tax deferred charge
|
|
(9.7
|
)%
|
|
1.3
|
%
|
|
(16.9
|
)%
|
|||
International tax rates differential
|
|
(31.9
|
)%
|
|
11.0
|
%
|
|
6.7
|
%
|
|||
Nondeductible stock based compensation
|
|
(14.8
|
)%
|
|
1.3
|
%
|
|
(0.8
|
)%
|
|||
Cross-border merger
|
|
(100.6
|
)%
|
|
—
|
%
|
|
—
|
%
|
|||
Unrecognized tax benefit
|
|
(15.2
|
)%
|
|
0.4
|
%
|
|
—
|
%
|
|||
State and local taxes (net of federal)
|
|
(9.6
|
)%
|
|
1.5
|
%
|
|
0.3
|
%
|
|||
Other
|
|
(2.3
|
)%
|
|
(4.9
|
)%
|
|
(2.3
|
)%
|
|||
Effective income tax rate
|
|
(324.8
|
)%
|
|
46.2
|
%
|
|
0.8
|
%
|
|||
|
|
|
|
|
|
|
||||||
Income tax provision (benefit) - at statutory tax rate
|
|
$
|
(1,215
|
)
|
|
$
|
25,876
|
|
|
$
|
(30,013
|
)
|
Non-deductible changes in fair value of contingent consideration
|
|
16,036
|
|
|
9,249
|
|
|
22,326
|
|
|||
Change in valuation allowance
|
|
(1,143
|
)
|
|
(7,425
|
)
|
|
(4,732
|
)
|
|||
Income tax deferred charge
|
|
938
|
|
|
980
|
|
|
15,273
|
|
|||
International tax rates differential
|
|
3,097
|
|
|
8,547
|
|
|
(6,023
|
)
|
|||
Nondeductible stock based compensation
|
|
1,436
|
|
|
1,004
|
|
|
693
|
|
|||
Cross-border merger
|
|
9,773
|
|
|
—
|
|
|
—
|
|
|||
Unrecognized tax benefit
|
|
1,475
|
|
|
290
|
|
|
—
|
|
|||
State and local taxes (net of federal)
|
|
934
|
|
|
1,170
|
|
|
(228
|
)
|
|||
Other
|
|
227
|
|
|
(3,784
|
)
|
|
2,060
|
|
|||
Income tax provision (benefit) - at effective income tax rate
|
|
$
|
31,558
|
|
|
$
|
35,907
|
|
|
$
|
(644
|
)
|
Unrecognized Tax Benefit Activity
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
|
||||||
Balance at January 1:
|
|
$
|
448
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Additions based on tax positions related to the current year
|
|
1,578
|
|
|
448
|
|
|
—
|
|
|||
Additions (reductions) for tax positions of prior years
|
|
(340
|
)
|
|
—
|
|
|
—
|
|
|||
Statute of limitations expiration
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Settlements
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Balance at December 31:
|
|
$
|
1,686
|
|
|
$
|
448
|
|
|
$
|
—
|
|
Net Deferred Tax Assets and Liabilities:
|
|
2016
|
|
2015
|
||||
|
|
|
|
|
||||
Deferred tax assets:
|
|
|
|
|
|
|
||
Net operating loss carryforwards
|
|
$
|
11,566
|
|
|
$
|
44,587
|
|
Stock based compensation
|
|
5,012
|
|
|
1,767
|
|
||
Fair value royalty agreements
|
|
3,386
|
|
|
2,435
|
|
||
Fair value contingent consideration
|
|
2,152
|
|
|
1,348
|
|
||
Other
|
|
583
|
|
|
1,037
|
|
||
Total deferred tax assets
|
|
22,699
|
|
|
51,174
|
|
||
Valuation allowances
|
|
(7,599
|
)
|
|
(45,516
|
)
|
||
Net deferred tax assets
|
|
15,100
|
|
|
5,658
|
|
||
|
|
|
|
|
||||
Deferred tax liabilities:
|
|
|
|
|
|
|
||
Amortization
|
|
(4,349
|
)
|
|
(5,649
|
)
|
||
Accounts receivable
|
|
(3,319
|
)
|
|
—
|
|
||
Total deferred tax liabilities
|
|
(7,668
|
)
|
|
(5,649
|
)
|
||
|
|
|
|
|
||||
Net deferred tax assets
|
|
$
|
7,432
|
|
|
$
|
9
|
|
Retirement Benefit Obligation Activity:
|
|
2016
|
|
2015
|
||||
|
|
|
|
|
||||
Retirement indemnity benefit obligation, beginning of year
|
|
$
|
2,170
|
|
|
$
|
2,350
|
|
Service cost
|
|
123
|
|
|
117
|
|
||
Interest cost
|
|
29
|
|
|
20
|
|
||
Benefits paid
|
|
—
|
|
|
(46
|
)
|
||
Actuarial loss (gain)
|
|
203
|
|
|
(27
|
)
|
||
Exchange rate changes
|
|
(94
|
)
|
|
(244
|
)
|
||
Retirement indemnity benefit obligation, end of year
|
|
$
|
2,431
|
|
|
$
|
2,170
|
|
Future Retirement Indemnity Benefit Obligation:
|
|
Balance
|
||
|
|
|
|
|
2017
|
|
$
|
—
|
|
2018
|
|
—
|
|
|
2019
|
|
11
|
|
|
2020
|
|
—
|
|
|
2021
|
|
—
|
|
|
Next five years
|
|
1,061
|
|
|
Total
|
|
1,072
|
|
Prepaid Expenses and Other Current Assets:
|
|
2016
|
|
2015
|
||||
|
|
|
|
|
|
|
||
Valued-added tax recoverable
|
|
$
|
736
|
|
|
$
|
1,099
|
|
Prepaid expenses
|
|
3,442
|
|
|
2,921
|
|
||
Advance to suppliers and other current assets
|
|
1,265
|
|
|
518
|
|
||
Income tax receivable
|
|
451
|
|
|
3,526
|
|
||
Total
|
|
$
|
5,894
|
|
|
$
|
8,064
|
|
Other Non-Current Assets:
|
|
2016
|
|
2015
|
||||
|
|
|
|
|
||||
Deferred tax assets
|
|
$
|
7,432
|
|
|
$
|
9
|
|
Other
|
|
99
|
|
|
158
|
|
||
Total
|
|
$
|
7,531
|
|
|
$
|
167
|
|
Accrued Expenses
|
|
2016
|
|
2015
|
||||
|
|
|
|
|
|
|
||
Accrued compensation
|
|
$
|
3,291
|
|
|
$
|
1,888
|
|
Accrued social charges
|
|
794
|
|
|
1,710
|
|
||
Customer allowances
|
|
7,981
|
|
|
5,710
|
|
||
Accrued contract research organization
|
|
1,764
|
|
|
—
|
|
||
Other
|
|
3,392
|
|
|
—
|
|
||
Total
|
|
$
|
17,222
|
|
|
$
|
9,308
|
|
Other Non-Current Liabilities
|
|
2016
|
|
2015
|
||||
|
|
|
|
|
|
|||
Provision for retirement indemnity
|
|
$
|
2,431
|
|
|
$
|
2,170
|
|
Customer allowances
|
|
905
|
|
|
—
|
|
||
Unrecognized tax benefits
|
|
1,565
|
|
|
291
|
|
||
Other
|
|
374
|
|
|
65
|
|
||
Total
|
|
$
|
5,275
|
|
|
$
|
2,526
|
|
Purchase Commitment:
|
|
Balance
|
||
|
|
|
||
2017
|
|
$
|
778
|
|
2018
|
|
1,032
|
|
|
2019
|
|
1,126
|
|
|
2020
|
|
1,126
|
|
|
2021
|
|
1,126
|
|
|
Thereafter
|
|
15,295
|
|
|
Total
|
|
$
|
20,483
|
|
Lease Commitment:
|
|
Balance
|
||
|
|
|
||
2017
|
|
$
|
1,117
|
|
2018
|
|
783
|
|
|
2019
|
|
717
|
|
|
2020
|
|
699
|
|
|
2021
|
|
441
|
|
|
Thereafter
|
|
600
|
|
|
Total
|
|
$
|
4,357
|
|
|
|
Payments Due by Period
|
||||||||||||||||||
Contractual Obligations:
|
|
Total
|
|
Less than
1 Year |
|
1 to 3
Years |
|
3 to 5
Years |
|
More than
5 Years |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Long-term debt
|
|
$
|
815
|
|
|
$
|
268
|
|
|
$
|
547
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Long-term related party payable (undiscounted)
|
|
278,236
|
|
|
35,226
|
|
|
57,466
|
|
|
60,587
|
|
|
124,957
|
|
|||||
Purchase commitments
|
|
41,721
|
|
|
12,266
|
|
|
11,908
|
|
|
2,252
|
|
|
15,295
|
|
|||||
Operating leases
|
|
4,982
|
|
|
1,390
|
|
|
1,837
|
|
|
1,155
|
|
|
600
|
|
|||||
Total contractual cash obligations
|
|
$
|
325,754
|
|
|
$
|
49,150
|
|
|
$
|
71,758
|
|
|
$
|
63,994
|
|
|
$
|
140,852
|
|
Stock-based Compensation Expense:
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
|
||||||
Cost of products and services sold
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
38
|
|
Research and development
|
|
3,523
|
|
|
1,587
|
|
|
1,027
|
|
|||
Selling, general and administrative
|
|
11,156
|
|
|
6,154
|
|
|
1,829
|
|
|||
Total stock-based compensation expense
|
|
$
|
14,679
|
|
|
$
|
7,741
|
|
|
$
|
2,894
|
|
Stock Option and Warrant Assumptions:
|
|
2016
|
|
2015
|
|
2014
|
|||
|
|
|
|
|
|
|
|||
Stock option grants:
|
|
|
|
|
|
|
|
|
|
Expected term (years)
|
|
6.25
|
|
|
6.25
|
|
|
6.25
|
|
Expected volatility
|
|
58.39
|
%
|
|
58.59
|
%
|
|
59.00
|
%
|
Risk-free interest rate
|
|
2.04
|
%
|
|
1.89
|
%
|
|
1.79
|
%
|
Expected dividend yield
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
|
|
|
|
|
|||
Warrant grants:
|
|
|
|
|
|
|
|
|
|
Expected term (years)
|
|
2.50
|
|
|
2.50
|
|
|
2.50
|
|
Expected volatility
|
|
60.57
|
%
|
|
55.00
|
%
|
|
58.00
|
%
|
Risk-free interest rate
|
|
0.82
|
%
|
|
0.89
|
%
|
|
0.75
|
%
|
Expected dividend yield
|
|
—
|
|
|
—
|
|
|
—
|
|
Stock Option Activity and Other Data:
|
|
Number of Stock
Options
|
|
Weighted Average
Exercise Price per Share
|
|
Weighted Average
Remaining
Contractual Life
|
|
Aggregate
Intrinsic Value
|
|||||
|
|
|
|
|
|
|
|
|
|||||
Stock options outstanding, January 1, 2016
|
|
2,326
|
|
|
$
|
13.84
|
|
|
|
|
|
|
|
Granted
|
|
1,505
|
|
|
10.68
|
|
|
|
|
|
|
||
Exercised
|
|
(15
|
)
|
|
6.50
|
|
|
|
|
|
|
||
Forfeited
|
|
(6
|
)
|
|
14.35
|
|
|
|
|
|
|
||
Expired
|
|
(78
|
)
|
|
31.70
|
|
|
|
|
|
|||
Stock options outstanding, December 31, 2016
|
|
3,732
|
|
|
$
|
12.07
|
|
|
8.48 years
|
|
$
|
3,681
|
|
Stock options exercisable, December 31, 2016
|
|
1,161
|
|
|
$
|
10.49
|
|
|
6.76 years
|
|
$
|
3,035
|
|
Warrant Activity and Other Data:
|
|
Number of
Warrants
|
|
Weighted Average Exercise Price per Share
|
|
Weighted Average Remaining
Contractual Life
|
|
Aggregate Intrinsic
Value
|
|||||
|
|
|
|
|
|
|
|
|
|||||
Warrants outstanding, January 1, 2016
|
|
668
|
|
|
$
|
16.97
|
|
|
|
|
|
|
|
Granted
|
|
291
|
|
|
13.59
|
|
|
|
|
|
|
||
Exercised
|
|
—
|
|
|
—
|
|
|
|
|
|
|
||
Forfeited
|
|
—
|
|
|
—
|
|
|
|
|
|
|
||
Expired
|
|
—
|
|
|
—
|
|
|
|
|
|
|||
Warrants outstanding, December 31, 2016
|
|
959
|
|
|
$
|
16.05
|
|
|
2.47 years
|
|
$
|
276
|
|
Warrants exercisable, December 31, 2016
|
|
668
|
|
|
$
|
17.12
|
|
|
1.97 years
|
|
$
|
276
|
|
Free Share Activity and Other Data:
|
|
Number of Free Share Awards
|
|
Weighted Average Grant Date
Fair Value
|
|||
|
|
|
|
|
|||
Non-vested free share awards outstanding, January 1, 2016
|
|
226
|
|
|
$
|
13.95
|
|
Granted
|
|
463
|
|
|
12.11
|
|
|
Vested
|
|
(115
|
)
|
|
13.44
|
|
|
Forfeited
|
|
(1
|
)
|
|
16.27
|
|
|
Non-vested free shares awards outstanding, December 31, 2016
|
|
573
|
|
|
$
|
12.57
|
|
Basic and Diluted Earnings (Loss) Per Share:
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
|
||||||
Net income (loss)
|
|
|
|
|
|
|
||||||
Net income (loss) from continuing operations
|
|
$
|
(41,276
|
)
|
|
$
|
41,798
|
|
|
$
|
(89,487
|
)
|
Net income (loss) from discontinued operations
|
|
—
|
|
|
—
|
|
|
4,018
|
|
|||
Net income (loss)
|
|
$
|
(41,276
|
)
|
|
$
|
41,798
|
|
|
$
|
(85,469
|
)
|
|
|
|
|
|
|
|
||||||
Weighted average shares:
|
|
|
|
|
|
|
|
|
|
|||
Basic shares
|
|
41,248
|
|
|
40,580
|
|
|
36,214
|
|
|||
Effect of dilutive securities—options and warrants outstanding
|
|
—
|
|
|
3,039
|
|
|
—
|
|
|||
Diluted shares
|
|
41,248
|
|
|
43,619
|
|
|
36,214
|
|
|||
|
|
|
|
|
|
|
||||||
Earnings (loss) per share - basic:
|
|
|
|
|
|
|
|
|
|
|||
Continuing operations
|
|
$
|
(1.00
|
)
|
|
$
|
1.03
|
|
|
$
|
(2.47
|
)
|
Discontinued operations
|
|
—
|
|
|
—
|
|
|
0.11
|
|
|||
Net income (loss) per share - basic
|
|
$
|
(1.00
|
)
|
|
$
|
1.03
|
|
|
$
|
(2.36
|
)
|
|
|
|
|
|
|
|
||||||
Earnings (loss) per share - diluted:
|
|
|
|
|
|
|
|
|
|
|||
Continuing operations
|
|
$
|
(1.00
|
)
|
|
$
|
0.96
|
|
|
$
|
(2.47
|
)
|
Discontinued operations
|
|
—
|
|
|
—
|
|
|
0.11
|
|
|||
Net income (loss) per share - diluted
|
|
$
|
(1.00
|
)
|
|
$
|
0.96
|
|
|
$
|
(2.36
|
)
|
Accumulated Other Comprehensive Income (Loss):
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
|
||||||
Foreign currency translation adjustment:
|
|
|
|
|
|
|
|
|
||||
Beginning balance
|
|
$
|
(22,312
|
)
|
|
$
|
(7,225
|
)
|
|
$
|
10,815
|
|
Net other comprehensive (loss) income
|
|
(1,024
|
)
|
|
(15,087
|
)
|
|
(18,040
|
)
|
|||
Balance at December 31,
|
|
(23,336
|
)
|
|
(22,312
|
)
|
|
(7,225
|
)
|
|||
|
|
|
|
|
|
|
||||||
Unrealized gain (loss) on marketable securities, net
|
|
|
|
|
|
|
|
|
||||
Beginning balance
|
|
(345
|
)
|
|
(198
|
)
|
|
—
|
|
|||
Net other comprehensive (loss) income, net of $16, ($20), ($0), tax, respectively
|
|
116
|
|
|
(147
|
)
|
|
(198
|
)
|
|||
Balance at December 31,
|
|
(229
|
)
|
|
(345
|
)
|
|
(198
|
)
|
|||
Accumulated other comprehensive loss at December 31,
|
|
$
|
(23,565
|
)
|
|
$
|
(22,657
|
)
|
|
$
|
(7,423
|
)
|
Revenue by Product:
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
|
||||||
Bloxiverz
|
|
$
|
82,896
|
|
|
$
|
150,083
|
|
|
$
|
10,411
|
|
Vazculep
|
|
39,796
|
|
|
20,151
|
|
|
—
|
|
|||
Akovaz
|
|
16,831
|
|
|
—
|
|
|
—
|
|
|||
Other
|
|
7,699
|
|
|
2,054
|
|
|
1,782
|
|
|||
Total product sales and services
|
|
147,222
|
|
|
172,288
|
|
|
12,193
|
|
|||
License and research revenue
|
|
3,024
|
|
|
721
|
|
|
2,782
|
|
|||
Total revenues
|
|
$
|
150,246
|
|
|
$
|
173,009
|
|
|
$
|
14,975
|
|
Revenue by Significant Customer:
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
|
||||||
Customer A
|
|
$
|
51,648
|
|
|
$
|
53,988
|
|
|
$
|
3,937
|
|
Customer B
|
|
39,359
|
|
|
60,420
|
|
|
3,859
|
|
|||
Customer C
|
|
30,916
|
|
|
43,434
|
|
|
3,563
|
|
|||
Customer D
|
|
17,728
|
|
|
—
|
|
|
—
|
|
|||
Other
|
|
7,571
|
|
|
14,446
|
|
|
834
|
|
|||
Total product sales and services
|
|
147,222
|
|
|
172,288
|
|
|
12,193
|
|
|||
License and research revenue
|
|
3,024
|
|
|
721
|
|
|
2,782
|
|
|||
Total revenues
|
|
$
|
150,246
|
|
|
$
|
173,009
|
|
|
$
|
14,975
|
|
Revenue by Geographic Region:
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
|
|
|
|
|||
United States
|
|
$
|
147,283
|
|
|
$
|
172,179
|
|
|
$
|
14,502
|
|
France
|
|
—
|
|
|
89
|
|
|
473
|
|
|||
Ireland
|
|
2,963
|
|
|
741
|
|
|
—
|
|
|||
Total
|
|
$
|
150,246
|
|
|
$
|
173,009
|
|
|
$
|
14,975
|
|
Long-lived Assets by Geographic Region:
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
|
|
|
|
|||
United States
|
|
$
|
42,021
|
|
|
$
|
34,515
|
|
|
$
|
47,077
|
|
France
|
|
2,524
|
|
|
2,317
|
|
|
1,704
|
|
|||
Ireland
|
|
202
|
|
|
258
|
|
|
—
|
|
|||
Total
|
|
$
|
44,747
|
|
|
$
|
37,090
|
|
|
$
|
48,781
|
|
Annual Service Minimum:
|
|
Amount
|
||
|
|
|
||
Year 1
|
|
$
|
4,250
|
|
Year 2
|
|
4,250
|
|
|
Year 3
|
|
4,250
|
|
|
Year 4
|
|
4,875
|
|
|
Year 5
|
|
4,875
|
|
|
Total
|
|
$
|
22,500
|
|
Net Income from Discontinued Operations:
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
|
||||||
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
14,967
|
|
Operating income (loss)
|
|
—
|
|
|
—
|
|
|
(875
|
)
|
|||
Gain on disposal
|
|
—
|
|
|
—
|
|
|
5,007
|
|
|||
Interest expense
|
|
—
|
|
|
—
|
|
|
(4
|
)
|
|||
Income tax provision
|
|
—
|
|
|
—
|
|
|
(110
|
)
|
|||
Net income from discontinued operations
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,018
|
|
Cash Flow Related to Discontinued Operation:
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
|
||||||
Capital expenditures
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,271
|
|
Depreciation and amortization
|
|
—
|
|
|
—
|
|
|
1,709
|
|
|||
Operating and investing non-cash elements
|
|
—
|
|
|
—
|
|
|
(740
|
)
|
•
|
Additional management review controls have been implemented and formalized across the organization in order to add additional levels of review and approval and to enhance segregation of duties at a functional level.
|
•
|
Supplemented our U.S. based Accounting and Finance organization through adding appropriate levels of subject matter knowledge and training, including hiring a Chief Financial Officer, Chief Accounting Officer, Senior Tax Director and a Head of U.S. Accounting. Each of these individuals has the appropriate experience, certification, education, and training in financial reporting and accounting for their role.
|
•
|
Implemented a company-wide ERP system to replace previously used accounting software as of January 1, 2016. The ERP system allowed for enhancements to and reliance on system based segregation of duties controls.
|
•
|
Management performed a comprehensive segregation of duties analysis related to system based roles as part of the ERP implementation and again as of Q4 2016.
|
•
|
Supplemented our U.S. based Accounting and Finance organizations through the hiring of a Senior Tax Director who has the appropriate experience, certification, education, and training in financial accounting and reporting related to accounting for income taxes. The position along with an appropriate level of review by the Chief Financial Officer and Chief Accounting Officer has allowed the Company to enhance reliance on internal procedures and decrease reliance on third parties providing accounting for income tax services.
|
•
|
Retained an outside consultant to assist the Company in documenting and testing the internal controls over financial reporting that are in place at the Company, including within the income tax process. Through this process, we have designed and maintained effective controls over the accounting and reporting for income taxes.
|
•
|
Implemented a more company-wide ERP system to replace previously used accounting software as of January 1, 2016. The new ERP system allowed for significant enhancements within our information technology control environment that were not available under the previous system of record.
|
•
|
Retained an outside consultant to assist the Company in documenting and testing the internal controls over financial reporting that are in place at the Company, including within the information technology area. Through this process, we have designed and maintained effective controls over the information technology area.
|
•
|
Retained an outside consultant to assist the Company in documenting and testing the internal controls over financial reporting that are in place at the Company and the serve in the role of the Company’s internal audit function. We have assessed the qualifications of the third party provider and determined that they have the appropriate experience, certification education and training in internal audit and controls to serve in this role.
|
•
|
Implemented a comprehensive and robust internal controls monitoring program in order to assess the design and operational effectiveness of our internal controls. This includes, but is not limited to, new quantitative and qualitative analytical analysis to monitor significant trends and transactions helping to timely detect potential material misstatements to our financial statements.
|
•
|
Supplemented our U.S. based Accounting and Finance organizations through adding appropriate levels of subject matter knowledge and training, including hiring a Chief Financial Officer, Chief Accounting Officer, a Senior Tax Director, a head of U.S. Accounting, an External Reporting Manager and others each of whom has the appropriate experience, certification, education, and training in financial accounting and reporting for their role.
|
•
|
Retained an outside consultant to assist the Company in documenting and testing the internal controls over financial reporting that are in place at the Company and the serve in the role of the Company’s internal audit function. We have assessed the qualifications of the third party provider and determined that they have the appropriate experience, certification education and training in internal audit and controls to serve in this role.
|
•
|
Supplemented our U.S. based Accounting and Finance organizations through adding appropriate levels of subject matter knowledge and training, including hiring a Chief Financial Officer, Chief Accounting Officer, Senior Tax Director, a Head of U.S. Accounting, an External Reporting Manager and others, each of whom has the appropriate experience, certification, education, and training in financial reporting and accounting for their role.
|
•
|
Developed, formalized and implemented additional management review controls across the organization in order to add more comprehensive levels of review and approval for significant transactions having complex U.S. GAAP and SEC reporting implications and routine transaction processing.
|
•
|
Developed new quantitative and qualitative analytical analysis as part of our financial close process to help in the early detection of potential material misstatements to our financial statements.
|
•
|
Enhanced and refined our quarterly and annual financial analysis and procedures to allow for more timely and substantive review of financial results before the filing of the quarterly reports of Form 10-Q and Annual Report on Form 10-K.
|
•
|
Implemented a company-wide ERP system to replace previously used accounting software as of January 1, 2016.
|
•
|
Retained an outside consultant to assist the Company in documenting and testing the internal controls over financial reporting that are in place at the Company, including within the financial close process.
|
•
|
Enhanced our documentation and support around product pricing approvals and subsequent changes to customer pricing,
|
•
|
Enhanced the information supporting the accounting and review process for gross to net accruals related to revenue,
|
•
|
Expanded procedures to include a comprehensive review of service provider reporting and end user considerations as well as more comprehensive periodic reviews of activities performed by third parties and validation of financial information received from third parties,
|
•
|
Enhanced the communication protocols between our Sales and Accounting functions to identify rebate arrangements and appropriately account for these arrangements
|
•
|
Expanded procedures to include more comprehensive quantitative and qualitative financial analysis related to revenue financial accounting and reporting.
|
(a)
|
Documents filed as part of this report:
|
1.
|
Financial Statements
|
2
.
|
Financial Statement Schedules
|
Deferred Tax Asset Valuation Allowance:
|
|
Balance,
Beginning of Period
|
|
Additions
(a)
|
|
Deductions
(b)
|
|
Other Changes
(c)
|
|
Balance,
End of Period
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
2016
|
|
$
|
45,516
|
|
|
$
|
6,873
|
|
|
$
|
(42,417
|
)
|
|
$
|
(2,373
|
)
|
|
$
|
7,599
|
|
2015
|
|
57,980
|
|
|
4,312
|
|
|
(11,737
|
)
|
|
(5,039
|
)
|
|
45,516
|
|
|||||
2014
|
|
69,939
|
|
|
8,453
|
|
|
(13,185
|
)
|
|
(7,227
|
)
|
|
57,980
|
|
a.
|
Additions to the deferred tax asset valuation allowance relate to movements on certain French, Irish and U.S. deferred tax assets where we continue to maintain a valuation allowance until sufficient positive evidence exists to support reversal.
|
b.
|
Deductions to the deferred tax asset valuation allowance include movements relating to utilization and removal of net operating losses and tax credit carryforwards, release in valuation allowance and other movements including adjustments following finalization of tax returns.
|
c.
|
Other changes to the deferred tax asset valuation allowance relate primarily to currency translation adjustments recorded directly in equity.
|
Exhibit Number
|
|
Exhibit Description
|
|
|
|
3.1
|
|
Constitution (containing the Memorandum and Articles of Association) of Avadel Pharmaceuticals plc (incorporated by reference to Appendix 15 of Exhibit 2.1 to the registrant’s current report on Form 8-K, filed on July 1, 2016)
|
|
|
|
4.1
|
|
Guaranty dated January 1, 2017 by Avadel Pharmaceuticals plc in favor of Breaking Stick Holdings, LLC (f/k/a Éclat Holdings, LLC) with respect to obligations under the Note Agreement filed as Exhibit 10.2 below (filed herewith)
|
|
|
|
4.2
|
|
Warrant to purchase 1,100,000 American Depositary Shares, each representing one ordinary share of Avadel Pharmaceuticals plc (incorporated by reference to Exhibit 4.1 to the registrant’s Post-Effective Amendment No. 2 to Form F-3 registration statement (No. 333-183961) on Form S-3, filed on January 6, 2017)
|
|
|
|
4.3
|
|
Warrant to purchase 2,200,000 American Depositary Shares, each representing one ordinary share of Avadel Pharmaceuticals plc (incorporated by reference to Exhibit 4.2 to the registrant’s Post-Effective Amendment No. 2 to Form F-3 registration statement (No. 333-183961) on Form S-3, filed on January 6, 2017)
|
|
|
|
10.1
|
|
Deposit Agreement dated as of January 3, 2017 among Avadel Pharmaceuticals plc, The Bank of New York, as Depositary, and holders from time to time of American Depositary Shares issued thereunder (including as an exhibit the form of American Depositary Receipt) (incorporated by reference to Exhibit 1.1 to the registrant’s current report on Form 8-K12B, filed on January 4, 2017 and amended January 6, 2017)
|
|
|
|
10.2*
|
|
Note Agreement among Flamel Technologies S.A., Flamel U.S. Holdings, Inc. and Éclat Holdings, LLC dated March 13, 2012 (incorporated by reference to Exhibit 4.1 to the registrant’s current report on Form 6-K, filed on March 21, 2012)
|
|
|
|
10.3
|
|
Registration Rights Agreement between Flamel Technologies S.A. and Éclat Holdings, LLC dated March 13, 2012 (incorporated by reference to Exhibit 4.5 to the registrant’s current report on Form 6-K, filed on March 21, 2012)
|
|
|
|
10.4
|
|
Facility Agreement among Flamel US Holdings, Inc., Deerfield Private Design Fund II, L.P. and Deerfield Private Design International II, L.P. dated December 31, 2012 (incorporated by reference to Exhibit 4.7 to the registrant’s annual report on Form 20-F for the year ended December 31, 2012, filed on April 30, 2013)
|
|
|
|
10.5*
|
|
Royalty Agreement among Éclat Pharmaceuticals LLC, Horizon Santé FLML, Sarl and Deerfield Private Design Fund II, L.P. dated December 31, 2012 (incorporated by reference to Exhibit 4.8 to the registrant’s annual report on Form 20-F for the year ended December 31, 2012, filed on April 30, 2013)
|
|
|
|
10.6*
|
|
Security Agreement between Éclat Pharmaceuticals, LLC and Deerfield Private Design Fund II, L.P. and Horizon Santé FLML, Sarl dated February 4, 2013 (incorporated by reference to Exhibit 4.9 to the registrant’s annual report on Form 20-F for the year ended December 31, 2012, filed on April 30, 2013)
|
|
|
|
10.7
|
|
Broadfin Facility Agreement effective as of December 3, 2013 (incorporated by reference to Exhibit 4.9 to the registrant’s annual report on Form 20-F for the year ended December 31, 2013, filed on April 30, 2014)
|
|
|
|
10.8*
|
|
Broadfin Royalty Agreement dated as of December 3, 2013 (incorporated by reference to Exhibit 4.10 to the registrant’s annual report on Form 20-F for the year ended December 31, 2013, filed on April 30, 2014)
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|
|
|
10.9
|
|
Asset Purchase Agreement by and among Flamel Technologies S.A. and Recipharm Pessac dated November 26, 2014 (incorporated by reference to Exhibit 4.11 to the registrant’s annual report on Form 20-F for the year ended December 31, 2014, filed on April 30, 2015)
|
|
|
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10.10
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|
Master Agreement on Supply of Services and Products by and between Avadel Technologies S.A. and Recipharm Pessac dated December 1, 2014 (incorporated by reference to Exhibit 4.12 to the registrant’s annual report on Form 20-F for the year ended December 31, 2014, filed on April 30, 2015)
|
10.11
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|
Service Agreement by and between Flamel Technologies S.A. and Recipharm Pessac dated December 1, 2014 (incorporated by reference to Exhibit 4.13 to the registrant’s annual report on Form 20-F for the year ended December 31, 2014, filed on April 30, 2015)
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|
|
|
10.12
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|
Supply Agreement by and between Flamel Technologies S.A. and Recipharm Pessac dated December 1, 2014 (incorporated by reference to Exhibit 4.14 to the registrant’s annual report on Form 20-F for the year ended December 31, 2014, filed on April 30, 2015)
|
|
|
|
10.13*
|
|
Membership Interest Purchase Agreement by and among Éclat Holdings LLC, Éclat Pharmaceuticals LLC, Flamel Technologies S.A. and Flamel US Holdings Inc. dated March 13, 2012 (incorporated by reference to Exhibit 4.15 to the registrant’s annual report on Form 20-F for the year ended December 31, 2014, filed on April 30, 2015)
|
|
|
|
10.14*
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|
Exclusive License Agreement by and between Elan Pharma International Limited and Flamel Ireland Limited dated September 30, 2015 (incorporated by reference to Exhibit 10.14 to the registrant’s Annual Report on Form 10-K for the year ended December 31, 2015, filed on March 15, 2016)
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|
|
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10.15
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|
Lease Agreement by and between Nine East, LLC and Eclat Pharmaceuticals LLC dated July 23, 2013 (incorporated by reference to Exhibit 10.15 to the registrant’s Annual Report on Form 10-K for the year ended December 31, 2015, filed on March 15, 2016)
|
|
|
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10.16
|
|
Lease Agreement by and between Grove II LLC and Eclat Pharmaceuticals LLC dated October 5, 2015 (incorporated by reference to Exhibit 10.16 to the registrant’s Annual Report on Form 10-K for the year ended December 31, 2015, filed on March 15, 2016)
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|
|
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10.17
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|
Lease Agreement by and between Channor Limited, Blanchardstown Corporate Park Management Limited, Flamel Ireland Limited, and Flamel Technologies S.A. dated July 3, 2015 (incorporated by reference to Exhibit 10.17 to the registrant’s Annual Report on Form 10-K for the year ended December 31, 2015, filed on March 15, 2016)
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|
|
|
10.18‡
|
|
Employment Agreement by and between Flamel Technologies S.A. and Sandra Hatten dated July 8, 2015 (incorporated by reference to Exhibit 10.18 to the registrant’s Annual Report on Form 10-K for the year ended December 31, 2015, filed on March 15, 2016)
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|
|
|
10.19‡
|
|
Employment Agreement by and between Flamel Technologies S.A. and Phillandas T. Thompson dated July 7, 2015 (incorporated by reference to Exhibit 10.19 to the registrant’s Annual Report on Form 10-K for the year ended December 31, 2015, filed on March 15, 2016)
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|
|
|
10.20
|
|
Membership Interest Purchase Agreement dated as of February 5, 2016 by and among James Flynn, Peter Steelman, Deerfield CSF, LLC, FSC Holding Company, LLC, FSC Therapeutics, LLC, FSC Laboratories, Inc., Flamel Technologies SA, and Flamel US Holdings, Inc. (incorporated by reference to Exhibit 10.20 to the registrant’s Annual Report on Form 10-K for the year ended December 31, 2015, filed on March 15, 2016)
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|
|
|
10.21‡
|
|
Rules Governing the Free Share Plan - December 2014 (incorporated by reference to Exhibit 10.21 to the registrant’s Annual Report on Form 10-K for the year ended December 31, 2015, filed on March 15, 2016)
|
|
|
|
10.22‡
|
|
Rules Governing the Free Share Plan - December 2014 (incorporated by reference to Exhibit 10.22 to the registrant’s Annual Report on Form 10-K for the year ended December 31, 2015, filed on March 15, 2016)
|
|
|
|
10.23‡
|
|
June 2015 Stock Warrant Rules (incorporated by reference to Exhibit 10.23 to the registrant’s Annual Report on Form 10-K for the year ended December 31, 2015, filed on March 15, 2016)
|
|
|
|
10.24‡
|
|
Subscription Form of Stock Warrant (incorporated by reference to Exhibit 10.24 to the registrant’s Annual Report on Form 10-K for the year ended December 31, 2015, filed on March 15, 2016)
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|
|
|
10.25‡
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|
December 2015 Stock Option Rules (incorporated by reference to Exhibit 10.25 to the registrant’s Annual Report on Form 10-K for the year ended December 31, 2015, filed on March 15, 2016)
|
|
|
|
10.26‡
|
|
Form of Stock Option Grant Letter (incorporated by reference to Exhibit 10.26 to the registrant’s Annual Report on Form 10-K for the year ended December 31, 2015, filed on March 15, 2016)
|
|
|
|
10.27
|
|
Common Draft Terms of Cross-Border Merger dated as of June 29, 2016 between Flamel Technologies S.A. and Avadel Pharmaceuticals Limited (subsequently renamed Avadel Pharmaceuticals plc) (incorporated by reference to Exhibit 2.1 to the registrant’s current report on Form 8-K, filed on July 1, 2016)
|
|
|
|
10.28‡
|
|
Rules Governing the Free Share Plan - August 2016 (incorporated by reference to Exhibit 99.1 to the registrant’s Registration Statement (No. 333-213154) on Form S-8, filed on August 16, 2016)
|
|
|
|
10.29‡
|
|
August 2016 Stock Option Rules (incorporated by reference to Exhibit 99.2 to the registrant’s Registration Statement (No. 333-213154) on Form S-8, filed on August 16, 2016)
|
|
|
|
10.30‡
|
|
August 2016 Stock Warrant Rules (incorporated by reference to Exhibit 99.3 to the registrant’s Registration Statement (No. 333-213154) on Form S-8, filed on August 16, 2016)
|
|
|
|
10.31
‡
|
|
Form of stock option grant letter for 2016 Stock Option Rules (filed herewith)
|
|
|
|
10.32
‡
|
|
Employment Agreement by and between Avadel Pharmaceuticals plc and Gregory J. Divis, dated January 4, 2017 (filed herewith)
|
|
|
|
14.1
|
|
Code of Business Conduct and Ethics (incorporated by reference to Exhibit 14.1 to the registrant’s current report on Form 8-K, filed on March 7, 2017)
|
|
|
|
14.2
|
|
Financial Integrity Policy (incorporated by reference to Exhibit 14.2 to the registrant’s current report on Form 8-K, filed on March 7, 2017)
|
|
|
|
21.1
|
|
List of Subsidiaries (filed herewith)
|
|
|
|
23.1
|
|
Consent of PricewaterhouseCoopers Audit (filed herewith)
|
|
|
|
23.2
|
|
Consent of Deloitte & Touche, LLP (filed herewith)
|
|
|
|
31.1
|
|
Certification of the Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith)
|
|
|
|
31.2
|
|
Certification of the Principal Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith)
|
|
|
|
32.1
|
|
Certification of the Chief Executive Officer pursuant to USC Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith) (1)
|
|
|
|
32.2
|
|
Certification of the Principal Financial Officer pursuant to USC Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith) (1)
|
|
|
|
101.INS
|
|
XBRL Instant Document
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Labels Linkbase Document
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
Avadel Pharmaceuticals PLC
|
|
|
|
Dated: March 28, 2017
|
By:
|
/s/ Michael S. Anderson
|
|
|
Name: Michael S. Anderson
|
|
|
Title: Chief Executive Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Michael S. Anderson
|
|
Chief Executive Office (Principal Executive Officer) and Director
|
|
March 28, 2017
|
Michael S. Anderson
|
|
|
|
|
|
|
|
|
|
/s/ Michael F. Kanan
|
|
Chief Financial Officer (Principal Financial Officer)
|
|
March 28, 2017
|
Michael F. Kanan
|
|
|
|
|
|
|
|
|
|
/s/ David P. Gusky
|
|
Corporate Controller (Principal Accounting Officer)
|
|
March 28, 2017
|
David P. Gusky
|
|
|
|
|
|
|
|
|
|
/s/ Craig R. Stapleton
|
|
Non-Executive Chairman of the Board and Director
|
|
March 28, 2017
|
Craig R. Stapleton
|
|
|
|
|
|
|
|
|
|
/s/ Guillaume Cerutti
|
|
Director
|
|
March 28, 2017
|
Guillaume Cerutti
|
|
|
|
|
|
|
|
|
|
/s/ Francis J.T. Fildes
|
|
Director
|
|
March 28, 2017
|
Francis J.T. Fildes
|
|
|
|
|
|
|
|
|
|
/s/ Benoit Van Assche
|
|
Director
|
|
March 28, 2017
|
Benoit Van Assche
|
|
|
|
|
|
|
|
|
|
/s/ Christophe Navarre
|
|
Director
|
|
March 28, 2017
|
Christophe Navarre
|
|
|
|
|
|
GUARANTOR:
|
|
|
|
|
|
AVADEL PHARMACEUTICALS PLC
|
|
|
|
|
|
By:
|
/s/ Michael S. Anderson
|
|
Name: Michael S. Anderson
|
|
|
Title: Chief Executive Officer
|
ACCEPTED:
|
|
|
|
|
|
BREAKING STICK HOLDINGS, LLC
|
|
|
|
|
|
By:
|
/s/ David Clark
|
|
Name: David Clark
|
|
|
Title: Authorized Signatory
|
|
Name of Entity
|
|
Jurisdiction
|
|
|
|
Avadel Pharmaceuticals plc (the “Guarantor”)
|
|
Ireland
|
1) Flamel Ireland Limited
|
|
Ireland
|
2)
Avadel Investment Company Limited
|
|
Cayman Islands
|
3) Avadel France Holding SAS
|
|
France
|
a)
Avadel Reseach SAS
|
|
France
|
4) Flamel U.S. Holdings, Inc.
|
|
United States (Delaware)
|
a) Eclat Pharmaceuticals, LLC
|
|
United States (Delaware)
|
i) Talec Pharmaceuticals, LLC
|
|
United States (Delaware)
|
b) FSC Holdings, LLC
|
|
United States (Delaware)
|
i) FSC Therapeutics, LLC
|
|
United States (Delaware)
|
ii) FSC Laboratories, Inc.
|
|
United States (Delaware)
|
x
) FSC Pediatrics, Inc.
|
|
United States (Delaware)
|
c) Avadel Operations Company, Inc.
|
|
United States (Delaware)
|
d) Avadel Management Company
|
|
United States (Delaware)
|
•
|
Options for [# of shares] (25%) may be exercised from [date of first anniversary of grant] to [date of ninth anniversary of grant] inclusive
|
•
|
Options for an additional [# of shares] (25%) may be exercised from [date of second anniversary of grant] to [date of ninth anniversary of grant] inclusive
|
•
|
Options for an additional [# of shares] (25%) may be exercised from [date of third anniversary of grant] to [date of ninth anniversary of grant] inclusive
|
•
|
Options for an additional [# of shares] (25%) may be exercised from [date of fourth anniversary of grant] to [date of ninth anniversary of grant] inclusive
|
Name
|
|
Jurisdiction
|
|
|
|
Avadel Pharmaceuticals plc (the Registrant):
|
|
Ireland
|
1) Avadel US Holdings, Inc.
(f/k/a Flamel US Holdings, Inc.)
|
|
United States (Delaware)
|
A. FSC Holdings, LLC
|
|
United States (Delaware)
|
i. Avadel Pharmaceuticals (USA), Inc.
(f/k/a FSC Laboratories, Inc.)
|
|
United States (Delaware)
|
1. Avadel Pediatrics, Inc.
(f/k/a FSC Pediatrics, Inc.)
|
|
United States (Delaware)
|
ii. FSC Therapeutics, LLC
|
|
United States (Delaware)
|
B. Avadel Legacy Pharmaceuticals, LLC
(f/k/a Éclat Pharmaceuticals LLC)
|
|
United States (Delaware)
|
i. Avadel Generics, LLC
(f/k/a Talec Pharma, Inc.)
|
|
United States (Delaware)
|
C. Avadel Management Corporation
|
|
United States (Delaware)
|
D. Avadel Operations Company, Inc.
|
|
United States (Delaware)
|
2) Flamel Ireland Ltd.
|
|
Ireland
|
3) Avadel Investment Company, Ltd.
|
|
Cayman Islands
|
4) Avadel France Holding SAS
|
|
France
|
A. Avadel Research SAS
|
|
France
|
|
/s/ Michael S. Anderson
|
|
Michael S. Anderson
|
|
Chief Executive Officer
|
|
/s/ Michael F. Kanan
|
|
Michael F. Kanan
|
|
Senior Vice President and Chief Financial Officer
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Michael S. Anderson
|
|
Michael S. Anderson
|
|
Chief Executive Officer
|
|
Avadel Pharmaceuticals plc
|
|
March 28, 2017
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Michael F. Kanan
|
|
Michael F. Kanan
|
|
Senior Vice President and Chief Financial Officer
|
|
Avadel Pharmaceuticals plc
|
|
March 28, 2017
|
|