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EX-31.2 - EX-31.2 - Aralez Pharmaceuticals Inc.arlz-20171231ex312975f9a.htm
EX-31.1 - EX-31.1 - Aralez Pharmaceuticals Inc.arlz-20171231ex311800458.htm
EX-23.1 - EX-23.1 - Aralez Pharmaceuticals Inc.arlz-20171231ex2312103e1.htm
EX-21.1 - EX-21.1 - Aralez Pharmaceuticals Inc.arlz-20171231ex2116158ca.htm
EX-10.38 - EX-10.38 - Aralez Pharmaceuticals Inc.arlz-20171231ex103867b99.htm
EX-10.37 - EX-10.37 - Aralez Pharmaceuticals Inc.arlz-20171231ex1037042b9.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549


FORM 10-K

 

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

FOR THE FISCAL YEAR ENDED DECEMBER 31, 2017

 

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

FOR THE TRANSITION PERIOD FROM      TO    .

 

Commission file number 001-37691


ARALEZ PHARMACEUTICALS INC. 

(Exact name of registrant as specified in its charter)

 

 

 

British Columbia, Canada

98-1283375

(State or other jurisdiction of incorporation or organization)

(I.R.S. Employer Identification No.)

 

7100 West Credit Avenue, Suite 101, Mississauga, Ontario, Canada L5N 0E4
(Address of registrant’s principal executive offices)

 

(905) 876-1118
(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Name of each exchange on which registered

Common Shares, without par value

NASDAQ Global Market, Toronto Stock Exchange

 

Securities registered pursuant to Section 12(g) of the Act:

Common Shares, no par value


Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒.

 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒.

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒. No ☐.

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒. No ☐.

 

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. .

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act (Check one):

 

 

 

 

Large accelerated filer ☐

Accelerated filer

Non-accelerated filer ☐

Smaller reporting company ☐

Emerging growth company ☐

 

 

Indicate by check mark whether the registrant is a shell company (as defined in 12b-2 of the Act). Yes ☐ No ☒.

 

The aggregate market value of the common shares held by non-affiliates of the registrant (computed by reference to the closing sale price of $1.35 for the registrant’s common shares as reported on the NASDAQ Global Market on June 30, 2017) was approximately $83.1 million. As of the close of business on March 8, 2018, there were 67,010,887 common shares issued and outstanding.

 

DOCUMENTS INCORPORATED BY REFERENCE:

 

Portions of Aralez Pharmaceuticals Inc.’s definitive proxy statement to be filed pursuant to Regulation 14A within 120 days after the end of the registrant’s fiscal year are incorporated by reference into Part III of this Form 10-K and certain documents are incorporated by reference into Part IV.

 

 

 


 

ARALEZ PHARMACEUTICALS INC.

ANNUAL REPORT ON FORM 10-K

TABLE OF CONTENTS

 

 

 

 

 

 

PAGE

 

Forward-Looking Information

2

 

 

 

 

PART I

3

 

 

 

Item 1. 

Business

3

 

 

 

Item 1A. 

Risk Factors

51

 

 

 

Item 1B. 

Unresolved Staff Comments

51

 

 

 

Item 2. 

Properties

52

 

 

 

Item 3. 

Legal Proceedings

52

 

 

 

Item 4. 

Mine Safety Disclosures

52

 

 

 

 

PART II

53

 

 

 

Item 5. 

Market for the Registrant’s Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities

53

 

 

 

Item 6. 

Selected Financial Data

56

 

 

 

Item 7. 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

57

 

 

 

Item 7A. 

Quantitative and Qualitative Disclosures about Market Risk

69

 

 

 

Item 8. 

Financial Statements and Supplementary Data

70

 

 

 

Item 9. 

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

70

 

 

 

Item 9A. 

Controls and Procedures

70

 

 

 

Item 9B. 

Other Information

70

 

 

 

 

PART III

71

 

 

 

Item 10. 

Directors, Executive Officers and Corporate Governance

71

 

 

 

Item 11. 

Executive Compensation

71

 

 

 

Item 12. 

Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters

71

 

 

 

Item 13. 

 Certain Relationships and Related Transactions and Director Independence

71

 

 

 

Item 14. 

Principal Accounting Fees and Services

71

 

 

 

 

PART IV

75

 

 

 

Item 15. 

Exhibits, Financial Statement Schedules

72

 

 

 

Item 16. 

Form 10-K Summary

76

 

 

 

Signatures 

 

77

 

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This Annual Report on Form 10-K includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and within the meaning of applicable securities laws in Canada. Forward-looking statements include, but are not limited to, statements about cash and cash equivalents together with cash expected to be generated from our business currently believed to be sufficient to fund our operations for at least the next twelve months from March 13, 2018, continuing to explore and evaluate strategic business opportunities to enhance longer term liquidity, including by any combination of debt refinancing, additional cost savings initiatives and/or proceeds-generating transactions, the expected effects of cost savings initiatives, including the expected reduction in selling, general and administrative expense in 2018 relative to 2017, business development plans, our operating model and financial discipline, product launches, our strategies, plans, objectives, financial forecasts, goals, prospects, prospective products or product approvals, future performance or results of current and anticipated products, exposure to foreign currency exchange rate fluctuations, interest rate changes and other statements that are not historical facts, and such statements are typically identified by use of terms such as “may,” “will,” “would,” “should,” “could,” “expect,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “likely,” “potential,” “continue” or the negative or similar words, variations of these words or other comparable words or phrases, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements included herein represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. The forward-looking statements are subject to a number of risks and uncertainties which are discussed in the section entitled “Item 1A. Risk Factors” and elsewhere in this Annual Report on Form 10-K and those described from time to time in our future reports filed with the Securities and Exchange Commission (“SEC”) and securities regulatory authorities in Canada. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee future results, events, levels of activity, performance or achievement. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.

 

All dollar amounts are expressed in U.S. dollars unless otherwise noted. Amounts are expressed on an as-converted from Canadian dollar to U.S. dollar basis, as applicable, and are calculated using the conversion rates as of and for the periods ended December 31, 2017 unless otherwise noted.

 

Unless the context indicates otherwise, when we refer to “we,” “us,” “our,” “Aralez” or the “Company” in this Annual Report on Form 10-K, we are referring to Aralez Pharmaceuticals Inc. together with its wholly-owned subsidiaries.

 

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PART I

 

ITEM 1. Business

 

Our Company

 

Overview

 

Aralez is a global specialty pharmaceutical company focused on delivering meaningful products to improve patients’ lives while creating shareholder value by acquiring, developing and commercializing products primarily in cardiovascular and other specialty areas. Our parent corporation, Aralez Pharmaceuticals Inc. (“Aralez Parent”), was incorporated under the British Columbia Business Corporations Act (“BCBCA”) on December 2, 2015. Our global headquarters is located in Mississauga, Ontario, Canada, our U.S. headquarters is located in Princeton, New Jersey, United States, and our Irish headquarters is located in Dublin, Ireland. Aralez was formed for the purpose of facilitating the business combination of POZEN Inc., a Delaware corporation (“Pozen”), and Tribute Pharmaceuticals Canada Inc. (now known as Aralez Pharmaceuticals Canada Inc.), a corporation incorporated under the laws of the Province of Ontario, Canada (“Aralez Canada”), which transaction closed on February 5, 2016 (the “Merger”).

 

2017 and More Recent Highlights

  

·

In April 2017, the Company implemented a program of cost savings initiatives, which included a 32% reduction in its U.S. sales force and realignment of certain financial resources to support the launch of Zontivity® (vorapaxar), together with a significant decrease in marketing spend on Yosprala® (aspirin and omebrazole) and other cost reductions across the business.

 

·

On April 6, 2017, Aralez Pharmaceuticals US Inc. (“APUS”) and the United States Government (the “Government”) entered into a Modification of Contract for Toprol-XL® (metoprolol succinate) pursuant to which the Government exercised its first renewal option under the VA National Contract between APUS and the Government (the “VA Contract”), extending the term of the VA Contract by one year to April 28, 2018 with reduced pricing for the duration thereof.

 

·

On April 24, 2017, the Company commenced its phased launch of Zontivity utilizing 15 sales representatives deployed to high volume physicians who treat post-myocardial infarction (“MI”) and Peripheral Artery Disease (“PAD”) patients.

 

·

On May 8, 2017, Pozen entered into a license agreement with a multi-national pharmaceutical company pursuant to which Pozen granted a non-exclusive license to such company under a Japanese patent owned by Pozen. The non-exclusive license is limited to Japan. In consideration for this non-exclusive license, Pozen received an upfront payment of $4.0 million, plus contingent milestone payments and royalties under certain circumstances.

 

·

On June 8, 2017, the Company commenced the national U.S. launch of Zontivity, utilizing its full complement of U.S. sales representatives deployed to high volume physicians who treat post-MI and PAD patients.

 

·

On June 27, 2017, the Company announced that the United States District Court for the District of New Jersey upheld the validity of two patents owned by a subsidiary of Aralez and licensed to Horizon Pharma USA, Inc. covering Vimovo® (naproxen/esomeprazole magnesium), and further held that each defendant would infringe at least one of the two Aralez subsidiary's patents with their proposed generic naproxen/esomeprazole magnesium products.

 

·

On July 7, 2017, AstraZeneca AB (“AstraZeneca”), Aralez Pharmaceuticals Trading DAC (“Aralez Ireland”) and Aralez Pharmaceuticals Inc. entered into an amendment to that certain Asset Purchase Agreement, dated October 3, 2016 (the “Toprol-XL Asset Purchase Agreement”), pursuant to which Aralez Ireland acquired the U.S. rights to Toprol-XL and its authorized generic (the “AG” and together with branded Toprol-XL, the “Toprol-XL Franchise”).  Under the amendment, (1) the milestone payments payable under the Toprol-XL Asset Purchase Agreement were deferred and extended, and (2) the definition of net sales was amended.

 

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·

On November 9, 2017, the Company announced the implementation of additional cost saving initiatives designed to further increase its profitability and enhance its liquidity position.

 

·

On November 27, 2017, the Company entered into a Distribution and Supply Agreement (the “Lannett-Toprol-XL AG Agreement”) with Lannett Company, Inc. (“Lannett”) pursuant to which the Company supplies, and Lannett distributes, the Toprol-XL AG product in the United States. 

 

·

On March 13, 2018, the Company announced that it intends to discontinue sales of Yosprala in the United States.  The Company is currently assessing its options to optimize the value of this asset both in the United States and worldwide. 

Our Products

 

The Company currently commercializes a number of cardiovascular products in the United States as well as products for cardiovascular, pain management, dermatological allergy and certain other indications in Canada. In addition, the Company outlicenses certain products in exchange for royalties and/or other payments. Certain of our main products are described below.

 

Marketed Products – United States

 

Zontivity®

 

Zontivity is the first and currently the only approved therapy shown to inhibit the protease-activated receptor-1 (PAR-1), the primary receptor for thrombin on the platelet, which is considered to be the most potent activator of platelets. In the United States, Zontivity is indicated for the reduction of thrombotic cardiovascular events in patients with a history of heart attack (myocardial infarction) or in patients with narrowing of leg arteries, called peripheral arterial disease (PAD), and should be used in combination with daily aspirin and/or clopidogrel according to their indications or standard of care. We acquired the U.S. and Canadian rights to Zontivity from MSD International GmbH (as successor to Schering-Plough (Ireland) Company), an affiliate of Merck & Co., Inc. (“Merck”), on September 6, 2016 in exchange for an upfront payment of $25 million and certain future royalties and milestone payments, as described in Note 2, “Business Agreements,” in the accompanying notes to consolidated financial statements in more detail.

 

In June 2017, we initiated the full relaunch of Zontivity by our U.S. sales force and are currently assessing our plans with respect to the commercialization of Zontivity in Canada. Zontivity competes with certain products referred to as oral anti-platelets, which market is dominated by the generic offerings for clopidogrel bisulfate. There is also a competitive branded offering in this class: Brilinta®.

 

The Toprol-XL® Franchise

 

Toprol-XL is a cardioselective beta-blocker indicated for the treatment of hypertension, alone or in combination with other antihypertensives, the long term treatment of angina pectoris and treatment of stable, symptomatic (NYHA class II or III) heart failure of specific origins. Toprol-XL is an extended-release tablet that belongs to a family of high blood pressure medications known as beta-blockers. Extended-release tablets need to be taken only once a day. After swallowing Toprol-XL, the coating of the tablet dissolves, releasing a multitude of controlled release pellets filled with metoprolol succinate. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval of 24 hours. We acquired the U.S. rights to the Toprol-XL Franchise from AstraZeneca on October 31, 2016 in exchange for an upfront payment of $175.0 million, a payment for certain inventory and certain future royalties and contingent milestone payments, as described in Note 2, “Business Agreements” in the accompanying notes to consolidated financial statements in more detail. The Toprol-XL Franchise competes against several generic offerings for metoprolol succinate. 

 

Fibricor® and its Authorized Generic

 

Fibricor® (fenofibric acid)    is indicated as a complementary therapy along with diet for the treatment of severe hypertriglyceridemia and as a complementary therapy along with diet to reduce elevated LDL-C, Total-C, TG, and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia. Fibricor is currently

4


 

protected by four U.S. patents extending to August 20, 2027. In May 2015, we acquired the U.S. rights to Fibricor (fenofibric acid) and its related authorized generic. We began promoting Fibricor in the United States during the second quarter of 2016. Fibricor and its authorized generic compete against other cholesterol-lowering drugs known as fibrates. The large fibrate market is heavily genericized.

 

Marketed Products – Canada

 

Blexten ® (bilastine)

 

Bilastine is a second generation antihistamine drug for the symptomatic relief of allergic rhinitis and chronic spontaneous urticaria. Bilastine exerts its effect as a selective histamine H1 receptor antagonist, and has an effectiveness similar to other second generation antihistamines such as cetirizine, fexofenadine and desloratadine. It was developed in Spain by FAES Farma, S.A. In April 2016, Health Canada approved bilastine with the brand name Blexten (bilastine 20mg oral tablet) for the treatment of the symptoms of Seasonal Allergic Rhinitis (“SAR”) and Chronic Spontaneous Urticaria (“CSU”) (such as itchiness and hives). We began commercializing Blexten in Canada in December 2016.

 

We consider the competitive market for Blexten to be any and all antihistamines (H1 receptor antagonists) prescribed and approved for sale in Canada. In early 2017, the competitive product  Rupall™ (rupatadine) was launched in Canada.

 

Cambia®

 

Cambia® (diclofenac potassium for oral solution) is a non-steroidal anti-inflammatory drug (“NSAID”) and currently the only prescription NSAID approved in Canada for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older. Cambia was licensed from Nautilus Neurosciences, Inc. (“Nautilus”) in November 2010, which was acquired by Depomed, Inc. (“Depomed”) in December 2013. Cambia was approved by Health Canada in March 2012 and was commercially launched to specialists in Canada in October 2012 and broadly to all primary care physicians in February 2013.

 

We consider the competitive market for Cambia to be the triptan class of drugs or 5-HT1 receptor agonists as they are known, which include sumatriptan (Imitrex®), rizatriptan (Maxalt®), zolmitriptan (Zomig®), almotriptan (Axert®), naratriptan (Amerge®), eletriptan (Relpax®) and frovatriptan (Frova®).

 

Soriatane®

 

Soriatane® (acitretin) is indicated for the treatment of severe psoriasis (including erythrodermic and pustular types) and other disorders of keratinization. Soriatane is a retinoid, an aromatic analog of vitamin A. Soriatane was approved in Canada in 1994 and is the first and currently the only oral retinoid indicated for severe psoriasis. Soriatane is often used when milder forms of psoriasis treatments like topical steroids, emollients and topical tar-based therapies have failed. Soriatane is under license from Allergan Inc. (“Allergan”), and we have the exclusive rights to market Soriatane in Canada.

 

We consider the competitive market for Soriatane to be biologic therapies such as Enbrel®  (etanercept), Humira® (adalimumab) and Remicade®(infliximab), and oral agents such as cyclosporine and methotrexate. In July 2017 and November 2017, Health Canada issued Notices of Compliance for two generic versions of Soriatane and as of March  8, 2018, one of these generic versions had been launched on the market in Canada.

 

Proferrin®

 

Proferrin® (heme iron polypeptide) is an iron supplement used to prevent or treat those at risk of iron deficiency. We have the exclusive right to import and distribute Proferrin in Canada pursuant to a distribution agreement with Colorado Biolabs, Inc.

 

We consider the competitive market for Proferrin to be in the Heme iron class of iron supplements, which is composed of two directly competing products: (1) Hema-Fer, and (2) JAMP Heme iron, and the following indirectly competing products: (1) Polyride® and Feramax® (Polysaccharide-iron complex), and (2) Palafer® and Eurofer® (Ferrous

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fumarate).

 

Fiorinal®/Fiorinal® C

 

Fiorinal® (acetylsalicylic acid, caffeine and butalbital capsules) and Fiorinal® C (acetylsalicylic acid, caffeine, butalbital and codeine capsules) were originally approved by Health Canada in 1971 and 1970, respectively, for the relief of tension-type headaches. Fiorinal is a fixed dose combination drug that combines the analgesic properties of acetylsalicylic acid, with the anxiolytic and muscle relaxant properties of butalbital, and the central nervous system stimulant properties of caffeine. Fiorinal C expands on the properties of Fiorinal with the additional analgesic effect of codeine. Fiorinal and Fiorinal C are currently the only prescription products in Canada indicated for relief of tension type headaches. Fiorinal and Fiorinal C were acquired from Novartis AG and Novartis Pharma AG in October 2014.

 

We consider the competitive market for Fiorinal and Fiorinal C as the prescription NSAID class, which includes Naprosyn®, Anaprox®, Toradol®, and prescription analgesic/opiate combination class, which includes Percocet® and Tylenol® with codeine.

 

Bezalip® SR

 

Bezalip® SR (bezafibrate) is an established pan-peroxisome proliferator-activated receptor activator. Bezalip SR, used to treat hyperlipidemia (high cholesterol), has over 25 years of therapeutic use globally. Bezalip SR helps lower LDL-C and triglycerides while raising HDL-C levels. It also improves insulin sensitivity and reduces blood glucose levels, which in combination with the cholesterol effects may significantly lower the incidence of cardiovascular events and development of diabetes in patients with features of metabolic syndrome. Bezalip SR is contraindicated in patients with hepatic and renal impairment, pre-existing gallbladder disease, hypersensitivity to bezafibrate, or pregnancy or lactation. Bezalip SR is under license from Allergan, and we have the exclusive rights to market Bezalip SR in Canada and the United States. At this time, we are only marketing Bezalip SR in Canada.

 

We consider the competitive market for Bezalip SR to be the fibrates class of cholesterol-lowering treatments, which is composed of three competing molecules: (1) gemfibrozil (Lopid®), (2) bezafibrate (Bezalip SR), and (3) fenofibrate (Lipidil® in Canada or Tricor® in the United States). Further, there was a Bezalip SR generic entry into the Canadian market in the third quarter of 2016.

 

Out-Licensed Products

 

Vimovo®

 

Vimovo (naproxen/esomeprazole magnesium) is the brand name for a proprietary fixed-dose combination of enteric-coated naproxen, a pain-relieving non-steroidal anti-inflammatory drug (“NSAID”) and immediate-release esomeprazole magnesium, a proton pump inhibitor (“PPI”), in a single delayed-release tablet. We developed Vimovo in collaboration with AstraZeneca. On April 30, 2010, the U.S. Food and Drug Administration (“FDA”) approved Vimovo for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

 

In 2010, we officially transferred to AstraZeneca the investigational new drug application (“IND”) and new drug application (“NDA”) for the product such that AstraZeneca became responsible for the commercialization of Vimovo. In November 2013, AstraZeneca entered into an agreement for Horizon Pharma USA, Inc. (“Horizon”) to acquire the U.S. rights for Vimovo. Under the terms of the agreement, we receive from Horizon a 10% royalty on net sales of Vimovo sold in the United States, with guaranteed annual minimum royalty payments of $7.5 million. The guaranteed annual minimum royalty payments are applicable for each calendar year that certain patents which cover Vimovo are in effect and certain types of competing products are not on the market in the United States.  Horizon’s royalty payment obligation with respect to Vimovo expires on the later of (a) the last to expire of certain patents covering Vimovo, and (b) ten years after the first commercial sale of Vimovo in the United States. The royalty rate may be reduced to the mid-single digits in the event of a loss of market share as a result of certain competing products. In June 2017, the United States District Court for the District of New Jersey upheld the validity of two patents owned by Aralez and licensed to Horizon covering Vimovo in the United States.  Subject to a successful appeal of the decision by the generic competitors party to the suit, this decision is expected to delay generic entry until the expiration of the applicable patents.  There is ongoing litigation with respect to other patents covering Vimovo, which if we are successful (and

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subject to a provisional license granted to Actavis effective January 1, 2025), would further prevent generic entry by the  remaining generic competitors until March 2031.  See Note 13, “Commitments and Contingencies” in the accompanying notes to the consolidated financial statements in this report for more information.  In February 2018, we entered into an amendment to our license agreement with Horizon for Vimovo in the United States that allows Horizon to settle such litigation without our consent in certain circumstances.

 

AstraZeneca will continue to have rights to commercialize Vimovo outside of the United States and Japan and paid us a royalty of 6% on all sales within its territory through 2015, which increased to 10% commencing in the first quarter of 2016.  AstraZeneca’s royalty payment obligation with respect to Vimovo expires on a country-by country basis upon the later of (a) expiration of the last-to-expire of certain patent rights related to Vimovo in that country, and (b) ten years after the first commercial sale of Vimovo in such country.  The royalty rate may be reduced to the mid-single digits in the event of a loss of market share as a result of certain competing products. As the result of an unfavorable outcome in certain patent litigation in Canada, Mylan’s generic naproxen/esomeprazole magnesium tablets became available in Canada in May 2017, which may reduce our royalty rate in Canada in the future. 

 

Treximet®

 

Treximet (sumatriptan/naproxen sodium) is a migraine medicine that we developed in collaboration with Glaxo Group Limited, d/b/a GlaxoSmithKline (“GSK”). The product is formulated with our patented technology of combining a triptan, sumatriptan 85mg, with an NSAID, naproxen sodium 500mg, and GSK’s RT Technology™ in a single tablet. In 2008, the FDA approved Treximet for the acute treatment of migraine attacks, with or without aura, in adults. Treximet is currently available in the United States only.

 

In 2008, we transferred the IND and NDA for the product to GSK, which subsequently sold its rights in Treximet, including the related trademark, to Pernix Therapeutics Holdings, Inc. (“Pernix”) in 2014. As part of GSK’s divestiture to Pernix, restrictions on our right to develop and commercialize certain additional dosage forms of sumatriptan/naproxen combinations outside of the United States had been eliminated, allowing us to seek approval for these combinations on the basis of the approved NDA. GSK was previously, and Pernix is currently, responsible for the commercialization of Treximet in the United States, while we receive royalties based on net sales. In 2011, we sold to a financial investor, CPPIB Credit Investments Inc. (“CII”), for an upfront lump-sum, our rights to future royalty and milestone payments relating to Treximet sales in the United States and certain other products containing sumatriptan/naproxen sodium developed and sold by Pernix in the United States. By virtue of the agreement, we will also be entitled to receive a 20% interest in royalties, if any, paid on net sales of Treximet and such other products in the United States to CII relating to the period commencing in the second quarter of 2018. Four of the U.S. patents covering Treximet expired on February 14, 2018. The remaining U.S. patent covering Treximet expires on April 2, 2026 (including pediatric exclusivity).  Six companies filed abbreviated new drug applications (“ANDA”) with the FDA seeking approval to market a generic version of Treximet, which resulted in three generics permitted to launch in 2018 (as of February 28, 2018, one of these generic competitors had entered the market) and three other generics enjoined from launching until 2026. Pernix launched its own authorized generic of Treximet in February 2018.

 

 

Product Pipeline Updates

 

As noted above, we retained rights to develop and commercialize Treximet outside of the United States and plan to file a New Drug Submission with Health Canada with respect to Treximet in early 2018.  If a New Drug Submission is filed in early 2018, we expect the review to be completed and, if applicable, the product approved for marketing, in the first half of 2019.  Also as noted above, we acquired the Canadian rights to Zontivity (in addition to the U.S. rights) and are assessing our plans with respect to the commercialization of this product in Canada, which is already an approved product in Canada.  Lastly, while we announced that we intend to discontinue of sales of Yosprala in the United States, we are currently assessing our options to optimize the value of this asset both in the United States and worldwide.

 

Sales and Marketing

 

The Company’s sales and marketing strategy is focused on the organic growth of existing marketed products through several key activities. First, our analytics team seeks to ensure that our sales force targets appropriate prescribers of our medications or medications that compete with our products. We create demand by calling on and providing healthcare professionals with reliable and trustworthy information, supported by our clinical trials and from other

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credible sources, and by coordinating and facilitating continuing health education events in targeted areas. Second, we support our products by providing physicians and other healthcare practitioners with quality patient care materials. Third, we endeavor to ensure that our products are accessible through all major wholesalers and distributors in the United States and Canada, and manage our supply chain efficiently to ensure that it can meet demand.

 

Our current U.S. sales force consists of approximately 75 sales representatives. In Canada, we have approximately 30 sales representatives (including seven contract sales representatives). The Company considers its sales force to be very experienced and well trained. Additionally, we offer our representatives a competitive incentive plan based on the achievement of results.

 

Manufacturing

 

We currently have no manufacturing capability. We outsource the manufacturing of our proprietary products to pharmaceutical manufacturing facilities operated by third-party contractors. These facilities comply with the FDA’s current Good Manufacturing Practices (“cGMP”) regulations and applicable Health Canada regulations, including in accordance with Health Canada’s cGMP requirements. See the section entitled “Item 1. Business – Government Regulations and Other Considerations” for a further discussion regarding the regulations that pharmaceutical manufacturing facilities are subject to. We believe these facilities have sufficient excess capacity at present to meet our short and long-term objectives.

 

Our licensed products are manufactured by authorized, third-party, contract manufacturing organizations in various places throughout the world. Our manufacturers are all approved fabricators of pharmaceutical products according to the FDA and Health Canada, as applicable. Our proprietary and licensed products are packaged by third-party contract manufacturers.

 

To date, we have entered into arrangements with third-party manufacturers for the supply of formulated and packaged clinical trial materials, drug products, active ingredients and other ingredients used in the manufacturing of our products. Certain of our material manufacturing arrangements include:

·

In connection with our acquisition of the Toprol-XL Franchise, we entered into a Supply Agreement with AstraZeneca pursuant to which (except as expressly set forth therein) AstraZeneca acts as our exclusive manufacturer and supplier of Toprol-XL and its authorized generic, as described in more detail in Note 2, “Business Agreements,” in the accompanying notes to consolidated financial statements.

·

In connection with our acquisition of Zontivity in 2016, Merck agreed to supply Zontivity to us for a period of up to three years from closing of such acquisition.  As we work toward effectuating a technical transfer to a third party, we have completed the transfer of the packaging component to a third party provider.

·

Under our arrangements with GSK and Pernix for Treximet and AstraZeneca and Horizon for Vimovo, it is the obligation of our partners to obtain commercial supplies of products developed thereunder.

 

Use of third-party manufacturers enables us to focus on our development and sales/commercialization activities, minimize fixed costs and capital expenditures and gain access to advanced manufacturing process capabilities and expertise. We plan to continue to rely on third-party manufacturers to manufacture our compounds and final products.

 

Industry and Competition

 

The pharmaceutical industry is highly competitive and is characterized by rapidly changing markets, technology, emerging industry standards and frequent introduction of new products. We believe that competition in our market is based on, among other things, product safety, efficacy, convenience of dosing, reliability, availability and price. The market is dominated by a small number of highly-concentrated global competitors, many of which boast substantially greater resources than the Company. Given the size and scope of the competition, there can be no assurance that the Company will maintain or grow our current market position in its therapeutic areas, or that developments by others will not render our products or technologies non-competitive or obsolete. In addition, some of our competitors have substantially greater financial, research and development, manufacturing, marketing and human resources and greater experience than we do in product discovery, development, clinical trial management, FDA, Health Canada, and European Medicines Agency (“EMA”) regulatory review, manufacturing and marketing, which may enable them to

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compete more effectively than we can.

 

The Company faces product competition from companies marketing competing pharmaceutical products and medical devices worldwide, particularly in the United States, Canada and the European Union (“EU”), and potentially on new products that could be launched in the future. See also the section entitled “Item 1. Business – Our Products” in this Annual Report on Form 10-K for a discussion of the other products that specifically compete with the Company’s products.

 

Furthermore, the pricing of pharmaceutical products is subject to increased pressure and scrutiny from government and other payors.  See “Item 1. Business – Government Regulation and Other Considerations” in this Annual Report on Form 10-K for further discussion regarding pricing considerations in the pharmaceutical industry.  In addition, certain of our products are subject to increased pricing pressure from generic competitors.  For example, there are several suppliers of generic versions of Toprol-XL, including a new supplier approved by the FDA in February 2018.  In addition, other generic manufacturers may enter the market for metropolol succinate.  Such increased generic competition could have the effect of additional price erosion for the product.

 

Patent and Proprietary Protection

 

We have obtained and intend to actively seek to obtain, when appropriate, protection for our products and proprietary technology by means of U.S., Canadian and other foreign patents, trademarks and contractual arrangements. In addition, we rely upon trade secrets and contractual agreements to protect certain of our proprietary technology and products.

 

While trade secret protection is an essential element of our business and we have taken security measures to protect our proprietary information and trade secrets, we cannot give assurance that our unpatented proprietary technology will afford us significant commercial protection. We seek to protect our trade secrets by entering into confidentiality agreements with third parties, employees and consultants. Our employees and consultants also sign agreements requiring that they assign to the Company their interests in intellectual property arising from their work for us. All employees sign an agreement not to engage in any conflicting employment or activity during their employment with us and not to disclose or misuse our confidential information. However, it is possible that these agreements will be breached or invalidated, and if so, there may not be an adequate corrective remedy available. Accordingly, we cannot ensure that employees, consultants or third parties will not breach the confidentiality provisions in such contracts or infringe or misappropriate our trade secrets and other proprietary rights or that the measures we are taking to protect our proprietary rights will be adequate.

 

We have issued U.S. and Canadian patents and pending U.S. and Canadian patent applications, as well as other pending foreign patent applications or issued foreign patents, relating to our marketed products and product candidates. We also have U.S., Canadian and other foreign patent applications pending relating to novel product concepts. There can be no assurance that our patent applications will issue as patents or, with respect to our issued patents, that they will provide us with significant protection. The following provides a general description of our patent portfolio and is not intended to represent an assessment of claim limitations or claim scope.

 

PN (Vimovo)

 

We have issued patents in the United States, Australia, Canada, Europe, Eurasia, Israel, Mexico, Japan and Norway, with claims directed to certain compositions containing a combination of acid inhibitors (including PPIs) and NSAIDs. The issued patents also have claims to treatment methods involving the use of such compositions. The issued U.S. patents are expected to expire between May 2022 and February 2023. The European patent will expire in May 2022, but we have obtained supplementary protection certificates (“SPCs”) for Vimovo that extend to dates between November 2025 and May 2026, depending on the country. We expect the patents outside of the United States and Europe to expire in May 2022.

 

We, together with AstraZeneca, have filed joint patent applications relating to Vimovo. We have an issued U.S. patent and an issued Canadian patent related to the pharmacodynamics profile of Vimovo that will expire in October of 2031 and June of 2030, respectively. Foreign counterparts, if granted, are expected to expire in September 2030. We also have two issued U.S. patents and one issued Canadian patent related to methods of treatment with Vimovo in patients taking low dose aspirin, which will expire as late as March of 2031 and September of 2029, respectively. Any related

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patents that issue outside the U.S. are expected to expire in September of 2029.

 

PA (Yosprala)

 

One of the patent families covering Vimovo also covers proton pump inhibitor-aspirin (“PA”) products. We have issued patents in the United States, Australia, Canada, Eurasia, Europe, Israel, Japan, Mexico and Norway, with claims directed to certain compositions containing a combination of acid inhibitors (including PPIs) and NSAIDs (including aspirin). The issued patents in Australia, Eurasia and New Zealand also have claims to treatment methods involving the use of such compositions. We have one issued patent, a pending U.S. patent application, and several non-U.S. applications that have claims directed to the use of compositions containing omeprazole and aspirin, and to various treatment methods involving such compositions.

 

The issued U.S. patents and related U.S. patent applications from the Vimovo family are expected to expire between May 2022 and February 2023. The European patent will expire in May 2022, but we expect to apply for SPCs for PA upon approval. We expect the patents outside of the United States and Europe to expire in May 2022. A second family directed to PA in particular, which has issued in certain non-U.S. countries, will expire in June of 2030. A third family, also directed to PA in particular, will expire in late 2032 with potential patent term adjustment into early 2033.

 

MT 400 (Treximet)

 

We have issued patents in Australia, Canada, Europe, Israel, Japan, Norway and the United States with claims relating to formulations of MT 400. We expect the patents related to formulations of MT 400 to expire in December 2023 outside the United States and, including pediatric exclusivity, in April 2026 in the United States. Four of the U.S. patents covering Treximet expired on February 14, 2018. Six companies filed ANDAs with the FDA seeking approval to market a generic version of Treximet, which resulted in three generics permitted to launch in 2018 (as of February 28, 2018, one of these generic competitors had entered the market) and three other generics enjoined from launching until 2026. Pernix launched its own authorized generic of Treximet in February 2018.

 

 

Vorapaxar (Zontivity)

 

We have acquired certain patent rights from Merck relating to Zontivity. The U.S. portfolio includes one pending U.S. application and nineteen issued U.S. patents. The pending case covers vorapaxar in a pharmaceutical composition, while the issued patents cover vorapaxar itself (3), intermediates (2), synthesis of vorapaxar (3), synthesis of intermediates (6), voraxapar as a cocrystal with aspirin (1), an active metabolite of voraxapar (1), and structurally-related compounds (3). The portfolio also includes one pending Canadian application relating to an intermediate of vorapaxar, and three issued Canadian patents covering vorapaxar itself, synthesis of vorapaxar, and a pharmaceutical composition containing vorapaxar or a drug combination.

 

Expiration dates for the U.S. cases range from June 2021 to July of 2028. Expiration dates for the Canadian cases range from April 2023 to June 2027. With respect to the patents covering vorapaxar per se, these expire between June 2021 and May of 2024, with possible extension to 2027.

 

Other Patents

 

With respect to Cambia, we have rights to a patent through our licensing agreement with Depomed, which we expect to expire in June 2026 in Canada. With respect to Fibricor, we have four issued patents in the United States, which we expect to expire in August 2027. In addition to the patents for the products discussed above, we also have patents or rights to patents with respect to Blexten, Uracyst, Durela, Moviprep, Resultz and Bedbugz.

 

Government Regulations and Other Considerations

 

The FDA in the United States, Health Canada in Canada, EMA in the EU and comparable regulatory agencies in foreign countries impose substantial requirements on the clinical development, manufacture and marketing of pharmaceutical products and product candidates. These agencies and other federal, state, provincial and local entities regulate research and development activities and the testing, manufacture, packaging, importing, distribution, quality control, safety, effectiveness, labeling, storage, record-keeping, approval and promotion of our products and product

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candidates. All of our product candidates will require regulatory approval before commercialization. In particular, therapeutic product candidates for human use are subject to rigorous preclinical and clinical testing and other statutory and regulatory requirements of the United States, Canada, the EU and foreign countries. Obtaining these marketing approvals and subsequently complying with ongoing statutory and regulatory requirements is costly and time-consuming. Any failure by us or our collaborators, licensors or licensees to obtain, or any delay in obtaining, regulatory approvals or in complying with other regulatory requirements could adversely affect the commercialization of our products and product candidates then being developed by us and our ability to receive product or royalty revenues.

 

United States Regulatory Overview

 

In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, as amended (“FFDCA”), and implements regulations. If we fail to comply with the applicable requirements at any time during the product development process, approval process or after approval, we may become subject to administrative or judicial sanctions. The steps required before a new drug product candidate may be distributed commercially in the United States generally include:

 

·

conducting appropriate preclinical laboratory evaluations of the product candidate’s chemistry, formulation and stability and preclinical studies in animals to assess the potential safety and efficacy of the product candidate;

 

·

submitting the results of these evaluations and tests to the FDA, along with manufacturing information and analytical data, in an IND;

 

·

obtaining approval of Institutional Review Boards to introduce the drug into humans in clinical studies;

 

·

initiating clinical trials under the IND and addressing any safety or regulatory concerns of the FDA;

 

·

conducting adequate and well-controlled human clinical trials that establish the safety and efficacy of the product candidate for the intended use, typically in the following three stages, which are often sequential but may overlap:

 

o

Phase 1: The product is initially introduced into human subjects or patients and tested for safety, dose tolerance, absorption, metabolism, distribution and excretion.

 

o

Phase 2: The product candidate is studied in patients to identify possible adverse effects and safety risks, to determine dosage tolerance and the optimal dosage, and to collect some efficacy data.

 

o

Phase 3: The product candidate is studied in an expanded patient population at multiple clinical study sites, to confirm efficacy and safety at the optimized dose, by measuring primary and secondary endpoints established at the outset of the study. In most cases, the FDA requires two adequate and well‑controlled Phase 3 clinical trials to demonstrate the efficacy of the drug.

 

·

submitting the results of preclinical studies and clinical trials, as well as chemistry, manufacturing and control information, on the product candidate to the FDA in an NDA; and

 

·

obtaining FDA approval of the NDA prior to any commercial sale or shipment of the product candidate.

 

The foregoing process can take a number of years and requires substantial financial resources.

 

The results of preclinical studies and initial clinical trials are not necessarily predictive of the results from large-scale clinical trials, and clinical trials may be subject to additional costs, delays or modifications due to a number of factors, including the difficulty in obtaining enough patients, clinical investigators, product candidate supply and financial support.

 

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Post-Marketing Requirements

 

Even after FDA approval has been obtained, further studies, including post-marketing studies, may be required. Results of post-marketing studies may limit or expand the further marketing of the products. If we propose any modifications to a product, including changes in indication, manufacturing process, manufacturing facility or labeling, a supplement to our NDA may be required to be submitted to the FDA and approved.

 

The FDA may also require testing and surveillance programs to monitor the effect of approved product candidates that have been commercialized, and the FDA has the power to prevent or limit further marketing of a product candidate based on the results of these post-marketing programs. Upon approval, a product candidate may be marketed only in those dosage forms and for those indications approved in the NDA.

 

In addition to obtaining FDA approval for each indication to be treated with each product, each domestic product manufacturing establishment must register with the FDA and list its products with the FDA. Moreover, the submission of applications for approval may require additional time to complete manufacturing stability studies. Foreign establishments manufacturing product for distribution in the United States also must register their establishments and list their products with the FDA.

 

Any product candidates manufactured or distributed by us pursuant to FDA approvals are subject to extensive continuing regulation by the FDA, including record-keeping requirements and reporting of adverse experiences with the product candidate. In addition to continued compliance with standard regulatory requirements, the FDA may also require post-marketing testing and surveillance to monitor the safety and efficacy of the marketed product. Adverse experiences and reports of adverse experiences in the medical literature with the product candidate or its components must be reported to the FDA. Product approvals may be affected and even withdrawn if compliance with regulatory requirements is not maintained or if problems concerning safety or efficacy of the product are discovered following approval.

 

The FFDCA also mandates that products be manufactured consistent with cGMP regulations. These requirements apply to both domestic and foreign establishments. In complying with the cGMP regulations, manufacturers must continue to spend time, money and effort in production, record-keeping, quality control and quality assurance, and auditing to ensure that the marketed product meets applicable specifications and other requirements. The FDA periodically inspects manufacturing facilities to ensure compliance with cGMP regulations. Failure to comply subjects the manufacturer to possible FDA action, such as warning letters, delay of approval of pending applications, suspension of manufacturing, seizure of the product, voluntary recall of a product or injunctive action, as well as possible civil and criminal penalties. We currently rely on, and intend to continue to rely on, third parties to manufacture our products and product candidates. These third parties will be required to comply with cGMP regulations.

 

Prescription drug advertising is subject to federal, state and foreign regulations. In the United States, the FDA regulates prescription drug promotion, including direct-to-consumer advertising. Prescription drug promotional materials must be submitted to the FDA in conjunction with their first use. Any distribution of prescription drug products and pharmaceutical samples must comply with the U.S. Prescription Drug Marketing Act (“PDMA”), a part of the FFDCA. In addition, Title II of the Federal Drug Quality and Security Act of 2013, known as the Drug Supply Chain Security Act or the DSCSA, has imposed new “track and trace” requirements on the distribution of prescription drug products by manufacturers, distributors, and other entities in the drug supply chain. These requirements are being phased in over a ten-year period. The DSCSA ultimately will require product identifiers (i.e., serialization) on prescription drug products in order to establish an electronic interoperable prescription product system to identify and trace certain prescription drugs distributed in the United States. The DSCSA replaced the prior drug “pedigree” requirements under the PDMA, and preempts existing state drug pedigree laws and regulations. The DSCSA also establishes new requirements for the licensing of wholesale distributors and third-party logistic providers. These licensing requirements preempt states from imposing licensing requirements that are inconsistent with, less stringent than, directly related to, or otherwise encompassed by standards established by FDA pursuant to the DSCSA. Until FDA promulgates regulations to address the DSCSA’s new national licensing standard, current state licensing requirements typically remain in effect.

Products manufactured in the United States for distribution abroad will be subject to FDA regulations regarding export, as well as to the requirements of the country to which they are shipped. These latter requirements are likely to cover the conduct of clinical trials, the submission of marketing applications, and all aspects of manufacturing and marketing. Such requirements can vary significantly from country to country.

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The Hatch-Waxman Amendments

Under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the “Hatch-Waxman Amendments”, a portion of a product’s U.S. patent term that was lost during clinical development and regulatory review by the FDA may be restored. The Hatch-Waxman Amendments also provide a process for listing patents pertaining to approved products in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”) and for a competitor seeking approval of an application that references a product with listed patents to make certifications pertaining to such patents. In addition, the Hatch-Waxman Amendments provide for a statutory protection, known as non-patent exclusivity, against the FDA’s acceptance or approval of certain competitor applications.

Patent Term Restoration

Patent term restoration can compensate for time lost during product development and the regulatory review process by returning up to five years of patent life for a patent that covers a new product or its use. This period is generally one-half the time between the effective date of an IND (falling after issuance of the patent) and the submission date of an NDA, plus the time between the submission date of an NDA and the approval of that application, provided the sponsor acted with diligence. Patent term restorations, however, cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval and only one patent applicable to an approved drug may be extended and the extension must be applied for prior to expiration of the patent. The USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration.

Orange Book Listing

In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent with claims covering the applicant’s product or method of using the product. Upon approval of a drug, each of the patents identified in the application for the drug are then published in the FDA’s Orange Book. Drugs listed in the Orange Book can, in turn, be cited by potential generic competitors in support of approval of an ANDA. An ANDA provides for marketing of a drug product that has the same active ingredients in the same strengths and dosage form as the listed drug and has been shown to be bioequivalent to the listed drug. Other than the requirement for bioequivalence testing, ANDA applicants are not required to conduct, or submit results of, preclinical or clinical tests to prove the safety or effectiveness of their drug product. Drugs approved in this way are commonly referred to as “generic equivalents” to the listed drug, and can often be substituted by pharmacists under prescriptions written for the original listed drug.

 

The ANDA applicant is required to certify to the FDA concerning any patents listed for the approved product in the FDA’s Orange Book. Specifically, the applicant must certify that: (i) the required patent information has not been filed; (ii) the listed patent has expired; (iii) the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or (iv) the listed patent is invalid or will not be infringed by the new product. The ANDA applicant may also elect to submit a Section VIII statement certifying that its proposed ANDA labeling does not contain (or carves out) any language regarding the patented method-of-use rather than certify to a listed method-of-use patent. If the applicant does not challenge the listed patents, the ANDA application will not be approved until all the listed patents claiming the referenced product have expired.

 

A certification that the new product will not infringe the already approved product’s listed patents, or that such patents are invalid, is called a Paragraph IV certification. If the ANDA applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and patent holders once the ANDA has been filed by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days of the receipt of a Paragraph IV certification automatically prevents the FDA from approving the ANDA until the earlier of 30 months, expiration of the patent, settlement of the lawsuit or a decision in the infringement case that is favorable to the ANDA applicant.

 

An applicant submitting an NDA under Section 505(b)(2) of the FFDCA, which permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted by, or for, the applicant and for which the applicant has not obtained a right of reference, is required to certify to the FDA regarding any patents listed in the Orange Book for the approved product it references to the same extent that an ANDA applicant would.

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Market Exclusivity

Market exclusivity provisions under the FFDCA also can delay the submission or the approval of certain applications. The FFDCA provides a five-year period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of an NDA for a new chemical entity (“NCE”). A drug is entitled to NCE exclusivity if it contains a drug substance no active moiety of which has been previously approved by the FDA. During the exclusivity period, the FDA may not accept for review an ANDA or a 505(b)(2) NDA submitted by another company for another version of such drug where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application may be submitted after four years if it contains a Paragraph IV certification. For a drug that has been previously approved by the FDA, the FFDCA also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example, for new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the new conditions of use and does not prohibit the FDA from approving ANDAs for drugs for the original conditions of use, such as the originally approved indication. Five-year and three-year exclusivity will not delay the submission or approval of a full NDA; however, an applicant submitting a full NDA would be required to conduct or obtain a right of reference to all of the non-clinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.

Anti-Kickback and False Claims Laws and Other Regulatory Matters

In the United States, we are subject to complex laws and regulations pertaining to healthcare “fraud and abuse,” including, but not limited to, the Federal Anti-Kickback Statute, the Federal False Claims Act, and other state and federal laws and regulations. The Federal Anti-Kickback Statute makes it illegal for any person, including a prescription drug manufacturer (or a party acting on its behalf) to knowingly and willfully solicit, receive, offer, or pay any remuneration that is intended to induce the referral of business, including the purchase, order, or prescription of a particular drug, for which payment may be made under a federal healthcare program, such as Medicare or Medicaid. Violations of this law are punishable by up to five years in prison, criminal fines, administrative civil money penalties, and exclusion from participation in federal healthcare programs. In addition, many states have adopted laws similar to the Federal Anti-Kickback Statute. Some of these state prohibitions apply to the referral of patients for healthcare services reimbursed by any insurer, not just federal healthcare programs such as Medicare and Medicaid. Due to the breadth of these federal and state anti-kickback laws, the absence of guidance in the form of regulations or court decisions, and the potential for additional legal or regulatory change in this area, it is possible that our future sales and marketing practices and/or our future relationships with healthcare professionals might be challenged under anti-kickback laws, which could harm us. Because we commercialize products that could be reimbursed under a federal healthcare program and other governmental healthcare programs, we have developed a comprehensive compliance program that establishes internal controls to facilitate adherence to the rules and program requirements to which we will or may become subject.

 

The Federal False Claims Act prohibits anyone from knowingly presenting, or causing to be presented, for payment to federal programs (including Medicare and Medicaid) claims for items or services, including drugs, that are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items or services. Although we would not submit claims directly to payers, manufacturers can be held liable under these laws if they are deemed to “cause” the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers or promoting a product off-label. In addition, our future activities relating to the reporting of wholesaler or estimated retail prices for our products, the reporting of prices used to calculate Medicaid rebate information and other information affecting federal, state and third-party reimbursement for our products, and the sale and marketing of our products, are subject to scrutiny under this law. For example, pharmaceutical companies have been found liable under the Federal False Claims Act in connection with their off-label promotion of drugs. Penalties for a False Claims Act violation include three times the actual damages sustained by the government, plus mandatory civil penalties of between $10,000 and $25,000 for each separate false claim, the potential for exclusion from participation in federal healthcare programs, and, although the Federal False Claims Act is a civil statute, conduct that results in a False Claims Act violation may also implicate various federal criminal statutes. In addition, private individuals have the ability to bring actions under the Federal False Claims Act and certain states have enacted laws modeled after the Federal False Claims Act.

There are also an increasing number of state laws with requirements for manufacturers and/or marketers of pharmaceutical products.  Some states require the reporting of expenses relating to the marketing and promotion of drug

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products and the reporting of gifts and payments to individual healthcare practitioners in these states.  Other states prohibit various marketing-related activities, such as the provision of certain kinds of gifts or meals.  Still other states require the reporting of certain pricing information, including information pertaining to and justification of price increases, or prohibit prescription drug price gouging.  In addition, states such as California, Connecticut, Nevada, and Massachusetts require pharmaceutical companies to implement compliance programs and/or marketing codes.  Many of these laws contain ambiguities as to what is required to comply with the laws. In addition, as discussed below, a similar federal requirement requires manufacturers to track and report to the federal government certain payments made to physicians and teaching hospitals made in the previous calendar year. These laws may affect our sales, marketing and other promotional activities by imposing administrative and compliance burdens on us. In addition, given the lack of clarity with respect to these laws and their implementation, our reporting actions could be subject to the penalty provisions of the pertinent state, and soon federal, authorities.

Government Programs for Marketed Drugs

Medicaid, the 340B Drug Pricing Program, and Medicare

Federal law requires that a pharmaceutical manufacturer, as a condition of having its products receive federal reimbursement under Medicaid and Medicare Part B, must pay rebates to state Medicaid programs for all units of its covered outpatient drugs dispensed to Medicaid beneficiaries and paid for by a state Medicaid program under either a fee-for-service arrangement or through a managed care organization. This federal requirement is effectuated through a Medicaid drug rebate agreement between the manufacturer and the Secretary of Health and Human Services. The Centers for Medicare and Medicaid Services (“CMS”) administers the Medicaid drug rebate agreements, which provide, among other things, that the drug manufacturer will pay rebates to each state Medicaid agency on a quarterly basis and report certain price information on a monthly and quarterly basis. The rebates are based on prices reported to CMS by manufacturers for their covered outpatient drugs. For innovator products, that is, drugs that are marketed under approved NDAs, the basic rebate amount is the greater of 23.1% of the average manufacturer price (“AMP”) for the quarter or the difference between such AMP and the best price for that same quarter. The AMP is the weighted average of prices paid to the manufacturer (1) directly by retail community pharmacies and (2) by wholesalers for drugs distributed to retail community pharmacies. The best price is essentially the lowest price available to non-governmental entities. Innovator products are also subject to an additional rebate that is based on the amount, if any, by which the product’s current AMP has increased over the baseline AMP, which is the AMP for the first full quarter after launch, adjusted for inflation. For non-innovator products, generally generic drugs marketed under approved abbreviated new drug applications, the basic rebate amount is 13% of the AMP for the quarter. Until recent amendments to the statute, this was the only rebate applicable to non-innovator products. However, as a result of a November 2015 amendment, non-innovator products are also subject to an additional rebate. The additional rebate is similar to that discussed above for innovator products, except that the baseline AMP quarter is the fifth full quarter after launch (for non-innovator multiple source drugs launched on April 1, 2013 or later) or the third quarter of 2014 (for those launched before April 1, 2013). The statutory definition of AMP was amended in 2010 by the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, “PPACA”). In February 2016, CMS published a final rule to further define AMP and provide clarification on other parts of the rebate program.  The terms of participation in the Medicaid drug rebate program impose an obligation to correct the prices reported in previous quarters, as may be necessary. Any such corrections could result in additional or lesser rebate liability, depending on the direction of the correction. In addition to retroactive rebates, if a manufacturer were found to have knowingly submitted false information to the government, federal law provides for civil monetary penalties for failing to provide required information, late submission of required information, and false information.

 

A manufacturer must also participate in a federal program known as the 340B drug pricing program in order for federal funds to be available to pay for the manufacturer’s drugs under Medicaid and Medicare Part B. Under this program, the participating manufacturer agrees to charge certain safety net healthcare providers no more than an established discounted price for its covered outpatient drugs. The formula for determining the discounted price is defined by statute and is based on the AMP and the unit rebate amount as calculated under the Medicaid drug rebate program, discussed above. Manufacturers have not been required to report any pricing information to the Health Resources and Services Administration (“HRSA”), but HRSA issued a notice proposing to collect such information from manufacturers on a quarterly basis and is in the process of preparing a system to operationalize this requirement. HRSA has also issued regulations relating to the calculation of the ceiling price as well as imposition of civil monetary penalties for each instance of knowingly and intentionally overcharging a 340B covered entity.

 

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Federal law also requires that manufacturers report data on a quarterly basis to CMS regarding the pricing of drugs that are separately reimbursable under Medicare Part B. These are generally drugs, such as injectable products, that are administered “incident to” a physician service and are not generally self-administered. The pricing information submitted by manufacturers is the basis for reimbursement to physicians and suppliers for drugs covered under Medicare Part B. As with the Medicaid drug rebate program, federal law provides for civil monetary penalties for failing to provide required information, late submission of required information, and false information.

 

Medicare Part D provides prescription drug benefits for seniors and people with disabilities. Medicare Part D beneficiaries have a gap in their coverage (between the initial coverage limit and the point at which catastrophic coverage begins) where Medicare does not cover their prescription drug costs, known as the coverage gap. However, by 2020, Medicare Part D beneficiaries will pay 25% of drug costs after they reach the initial coverage limit - the same percentage they were responsible for before they reached that limit - thereby closing the coverage gap. The cost of closing the coverage gap is being borne by innovator companies and the government through subsidies. Beginning in 2011, each manufacturer of drugs approved under NDAs was required to enter into a Medicare Part D coverage gap discount agreement and provide a 50% discount on those drugs dispensed to Medicare beneficiaries in the coverage gap, in order for its drugs to be reimbursed by Medicare Part D. The Bipartisan Budget Act of 2018 increased the manufacturer’s subsidy under the program from 50% to 70% of the negotiated price, beginning in 2019.

Federal Contracting/Pricing Requirements

Manufacturers are also required to make their covered drugs, which are generally drugs approved under NDAs, available to authorized users of the Federal Supply Schedule (“FSS”), of the General Services Administration. The law also requires manufacturers to offer deeply discounted FSS contract pricing for purchases of their covered drugs by the Department of Veterans Affairs, the Department of Defense (“DoD”), the Coast Guard, and the Public Health Service (including the Indian Health Service) in order for federal funding to be available for reimbursement or purchase of the manufacturer’s drugs under certain federal programs. FSS pricing to those four federal agencies for covered drugs must be no more than the Federal Ceiling Price (“FCP”), which is at least 24% below the Non-Federal Average Manufacturer Price (“Non-FAMP”) for the prior year. The Non-FAMP is the average price for covered drugs sold to wholesalers or other middlemen, net of any price reductions.

 

The accuracy of a manufacturer’s reported Non-FAMPs, FCPs, or FSS contract prices may be audited by the government. Among the remedies available to the government for inaccuracies is recoupment of any overcharges to the four specified federal agencies based on those inaccuracies. If a manufacturer were found to have knowingly reported false prices, in addition to other penalties available to the government, the law provides for civil monetary penalties of $100,000 per incorrect item. Finally, manufacturers are required to disclose in FSS contract proposals all commercial pricing that is equal to or less than the proposed FSS pricing, and subsequent to award of an FSS contract, manufacturers are required to monitor certain commercial price reductions and extend commensurate price reductions to the government, under the terms of the FSS contract Price Reductions Clause. Among the remedies available to the government for any failure to properly disclose commercial pricing and/or to extend FSS contract price reductions is recoupment of any FSS overcharges that may result from such omissions.

Tricare Retail Pharmacy Network Program

The DoD provides pharmacy benefits to current and retired military service members and their families through the Tricare healthcare program. When a Tricare beneficiary obtains a prescription drug through a retail pharmacy, the DoD reimburses the pharmacy at the retail price for the drug rather than procuring it from the manufacturer at the discounted FCP discussed above. In order for the DoD to realize discounted prices for covered drugs (generally drugs approved under NDAs), federal law requires manufacturers to pay refunds on utilization of their covered drugs sold to Tricare beneficiaries through retail pharmacies in DoD’s Tricare network. These refunds are generally the difference between the Non-FAMP and the FCP and are due on a quarterly basis. Absent an agreement from the manufacturer to provide such refunds, DoD will designate the manufacturer’s products as Tier 3 (non-formulary) and require that beneficiaries obtain prior authorization in order for the products to be dispensed at a Tricare retail network pharmacy. However, refunds are due whether or not the manufacturer has entered into such an agreement.

Branded Pharmaceutical Fee

A branded pharmaceutical fee is imposed on manufacturers and importers of branded prescription drugs (including authorized generics), generally drugs approved under NDAs (excluding orphan drugs). In each year between

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2011 and 2018, the aggregate fee for all such manufacturers will range from $2.5 billion to $4.1 billion, and then will remain at $2.8 billion in 2019 and subsequent years. This annual fee is apportioned among the participating companies based on each company’s sales of qualifying products to or utilization by certain U.S. government programs during the preceding calendar year. The fee became effective January 1, 2011, and is not deductible for U.S. federal income tax purposes. Utilization of generic drugs, generally drugs approved under ANDAs, is not included in a manufacturer’s sales used to calculate its portion of the fee.

 

U.S Pricing and Reimbursement Overview 

 

In the United States, pharmaceutical products are generally paid for by private insurance, various federal or state governmental programs, “out of pocket” by the patient, or some combination of the foregoing.  Recently, there has been an increased focus on drug pricing and although there are currently no direct government price controls over private sector purchases in the U.S., as discussed above, federal legislation requires pharmaceutical manufacturers to pay prescribed rebates on certain drugs to enable them to be eligible for reimbursement under certain public healthcare programs, such as Medicaid, and to offer brand drugs to certain federal agencies at statutorily mandated discounted prices. In addition, various states have adopted further mechanisms under Medicaid and other programs that seek to control drug prices, including by disfavoring certain higher priced drugs and by seeking supplemental rebates from manufacturers. Managed care has also become a potent force in the marketplace that increases downward pressure on the prices of pharmaceutical products.

 

Some recent developments on the federal level include the following:

 

·

The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (“ACA”) increased the minimum basic Medicaid rebate for branded prescription drugs from 15.1% to 23.1% and requires pharmaceutical manufacturers to pay states rebates on prescription drugs dispensed to Medicaid managed care enrollees. The ACA also revised the definition of AMP by changing the classes of purchasers included in the calculation, and expanded the entities eligible for discounted 340B pricing. Furthermore, the ACA provided for an alternate Medicaid rebate for “line extensions” (such as extended release formulations) of solid oral dosage forms of branded products.  The Bipartisan Budget Act of 2018 corrected the rebate formula for line extensions so that the alternate rebate amount from the ACA will be added to the base rebate, which will have the effect of increasing the total rebate for line extensions, effective as of October 1, 2018.

 

·

The ACA also contains a number of provisions, including provisions governing the way that healthcare is financed by both governmental and private insurers, enrollment in federal healthcare programs, reimbursement changes, increased funding for comparative effectiveness research for use in the healthcare industry, and enhancements to fraud and abuse requirements and enforcement, that will affect existing government healthcare programs and will result in the development of new programs.

 

We are unable to predict the future course of federal or state healthcare legislation and regulations, including regulations that may be issued to implement provisions of the ACA or any alternative legislation. In addition, recently, the current Presidential administration and certain legislators have expressed a continued interest in repealing all or portions of the ACA and replacing the ACA with new legislation. It is unclear whether, when and how that repeal will be effectuated and what the effect on the healthcare sector will be. The ACA or any alternative legislation and further changes in the law or regulatory framework that reduce our revenues or increase our costs could also have a material adverse effect on our business, financial condition and results of operations and cash flows.

 

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In addition, public and private healthcare payors control costs and influence drug pricing through a variety of mechanisms, including through negotiating discounts with the manufacturers and through the use of tiered formularies and other mechanisms that provide preferential access to certain drugs over others within a therapeutic class. Payors also set other criteria to govern the uses of a drug that will be deemed medically appropriate and therefore reimbursed or otherwise covered. In particular, many public and private healthcare payors limit reimbursement and coverage to the uses of a drug that are either approved by the FDA and/or appear in a recognized drug compendium. Drug compendia are publications that summarize the available medical evidence for particular drug products and identify which uses of a drug are supported or not supported by the available evidence, whether or not such uses have been approved by the FDA.

 

Canadian Regulatory Overview

 

Health Canada is the Canadian federal authority that regulates, evaluates and monitors the safety, effectiveness, and quality of drugs, medical devices, and other therapeutic products available to Canadians. Health Canada’s regulatory process for review, approval and regulatory oversight of products is similar to the regulatory process conducted by the FDA in the United States, the EMA in the EU, and other regulatory agencies around the world.

 

Prior to being given market authorization for a drug product, a manufacturer must present substantive scientific evidence of a product’s safety, efficacy and quality as required by the Food and Drugs Act (Canada) and its associated regulations, including the Food and Drug Regulations. This information is usually submitted in the form of a New Drug Submission (“NDS”) in Canada.

 

Health Canada performs a thorough review of the submitted information, sometimes using external consultants and advisory committees, to evaluate the potential benefits and risks of a drug. If, at the completion of the review, the conclusion is that the patient benefits outweigh the risks associated with the drug, the drug is issued a Notice of Compliance (“NOC”) and a Drug Identification Number (“DIN”), which permits the market authorization holder (i.e., the NOC and DIN holder) to market the drug in Canada.

 

Currently, the process for the review of a NDS typically takes approximately 1 to 2 years from the time that a manufacturer submits an NDS until Health Canada approves a drug. The length of time for review depends on the product being submitted and the size and quality of the submission. Health Canada’s target service standards for reviewing most NDSs is 300 days (plus an additional 45 days for screening the application). From April 1, 2016 to March 31, 2017, Health Canada’s average review time for a NDS for a new active substance was 391 days.

 

All establishments engaged in the fabrication, packaging/labeling, importation, distribution, and wholesale of drugs and operation of a testing laboratory relating to drugs are required to hold a Drug Establishment License to conduct one or more of the licensed activities unless expressly exempted under the Food and Drug Regulations. The basis for the issuance of a Drug Establishment License is to ensure the facility complies with cGMP as stipulated in the Food and Drug Regulations and as determined by cGMP inspection conducted by Health Canada. An importer of pharmaceutical products manufactured at foreign sites must also be able to demonstrate that the foreign sites comply with cGMP, and such foreign sites are included on the importer’s Drug Establishment License.

 

Regulatory obligations and oversight continue following the initial market approval of a pharmaceutical product. For example, every market authorization holder must report any new information received concerning adverse drug reactions, including timely reporting of serious adverse drug reactions that occur in Canada and any serious unexpected adverse drug reactions that occur outside of Canada. The market authorization holder must also notify Health Canada of any new safety and efficacy issues that it becomes aware of after the launch of a product.

 

Canadian Reimbursement Overview

 

After regulatory approval is received for a prescription drug, it can be sold to the public in accordance with the Food and Drugs Act and its regulations and applicable provincial pharmacy legislation and regulations. Revenues from prescription drug sales in Canada are usually generated through one of three sources:

 

·

Cash: Patients will pay “out of pocket” at their sole expense. It is estimated that 10% of all prescription dollars spent in Canada come from cash purchases.

 

·

Private Insurance: Approximately 45% of prescription dollars spent in Canada are reimbursed via

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third-party private insurers, under plans generally provided by patients’ employers. Patients may be reimbursed a percentage of the cost of covered drugs minus deductibles or co-pays. The availability for reimbursement of drugs varies according to the type of reimbursement plan designed by the insurance company. There are a number of private insurers operating in Canada that provide employee plans to private and public sector employers.

 

·

Government Drug Plans: Government drug plans cover the cost of nearly 45% of prescription dollars spent in Canada, and generally serve patients over the age of 65 or patients for whom the cost of medications represents a significant financial burden such as families receiving social assistance. Each provincial government pays the cost of drugs that are listed on their own provincial formulary, with some government drug plans requiring patients to be responsible for a co-payment.

 

 

After regulatory approval of a drug is granted, approval for reimbursement is typically sought from provincial governments and private insurance companies. Until provincial and private reimbursement is approved, the product is sold only via cash purchases. Decisions to list drugs for reimbursement on private and government formularies vary widely depending on the drug, indications, competitive products and price.

 

Sales of hospital products or products dispensed in the hospital are treated differently in Canada. All medications taken while in a hospital are fully reimbursed by the provincial governments. If a patient leaves the hospital and is prescribed a drug to be taken at home, this prescription would be paid for either by cash, private insurance or public insurance plans.

 

Common Drug Review (“CDR”)

 

The CDR was implemented in 2003 to provide formulary listing recommendations for new drugs to participating publicly-funded federal, provincial and territorial drug benefit plans in Canada. The CDR is administered by the Canadian Agency for Drugs and Technologies in Health.

 

The CDR consists of:

 

·

a systematic review of the available clinical evidence and a review of the pharmacoeconomic data for the drug; and

 

·

a listing recommendation made by the Canadian Expert Drug Advisory Committee.

 

Based on the targeted timeframes of the CDR, a review should be completed approximately 20 to 27 weeks following receipt of a manufacturer’s submission, after which recommendations are made to participating drug plans.

 

At the provincial and territorial level, products are reviewed on the basis of their cost-effectiveness, comparable utility to other similar products, projected utilization and cost implications to the publicly-funded drug budget. Each submission is reviewed but there is wide variance in the formulary decisions and the time taken to make such decisions. Provinces and territories may utilize the recommendations of the CDR or perform their own analysis.

 

Presently, all provinces and territories except Quebec use the CDR recommendations in their assessment, but make their formulary decisions independently from the CDR. In many provinces, the formulary committee may grant “restricted or limited use approvals” for a drug as a means of regulating the size of the patient population eligible for reimbursement for the cost of the drug and by encouraging physicians to use older generation products first before prescribing newer, sometimes more costly medications. Further, if a generic drug is available, the government funded drug plans will often choose to reimburse only for the cost of the generic drug. Often, the provinces, territories and federal government may require the manufacturer to enter into a product listing agreement to have a product added to a government funded formulary. Such product listing agreements commonly contain product pricing restrictions and may contain other terms between the government agency and the manufacturer, such as volume discounts or other amounts that may be payable by the manufacturer to the government agency.

 

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Pan-Canadian Pharmaceutical Alliance (pCPA)

 

The pan-Canadian Pharmaceutical Alliance (pCPA) was established 2010 to manage joint provincial and territorial negotiations for brand name medications in Canada.  The purpose of these negotiations is to achieve greater value for publicly funded drug programs. All brand name medications that have been assessed by the CDR are considered for negotiation through the pCPA.

 

Once CDR has issued its final recommendation, the pCPA will make a decision if negotiations will take place for the reviewed medication. If the pCPA decides to enter into a negotiation one jurisdiction will assume the role of lead negotiator. If an agreement is reached between participating jurisdictions and the manufacturer, a Letter of Intent is signed by both the manufacturer and the lead jurisdiction. Once the Letter of Intent is signed it is shared with all participating jurisdictions. At this point, each participating jurisdiction will make their own decision on funding the medication through their drug plan and enter into a jurisdiction-specific product listing agreement with the manufacturer.

 

 

Product Pricing Regulation on Certain Patented Drug Products

 

Patented drug products in Canada are subject to price regulation by the Patented Medicine Prices Review Board (“PMPRB”) pursuant to the Patent Act (Canada) and the Patented Medicines Regulations. Among other things, the PMPRB’s mandate is to ensure that prices of patented products in Canada are not excessive. For new patented products, the price is assessed taking into account the therapeutic improvement, if any, relative to its class and generally, the price in Canada is limited to either the cost of existing drugs sold in Canada in the same therapeutic class or the median of prices for the same drug sold in other specified industrial countries. For existing patented products, prices generally cannot increase by more than maximum price increase allowed applying the PMPRB’s Consumer Price Index adjustment methodology. The PMPRB monitors compliance through a review of the average transaction price of each patented drug product as reported by the patentee over a recurring six-month reporting period (patentees of pharmaceutical products have mandatory reporting obligations to the PMPRB).  The Patented Medicines Regulations have been proposed to be amended effective January 1, 2019, such that the factors that will be applied in assessing whether pricing of patented products is excessive will likely change as of that date, going forward.

 

 

The PMPRB does not approve prices for drug products in advance of their introduction to the market. The PMPRB provides guidelines from which companies like us set their prices at the time they launch their products. All patented pharmaceutical products introduced in Canada are subject to the post-approval, post-launch scrutiny of the PMPRB. Since the PMPRB does not pre-approve prices for a patented drug product in Canada, there may be risk involved in the determination of an allowable price selected for a patented drug product at the time of introduction to the market by the company launching such products in Canada. If the PMPRB does not agree with the pricing assumptions chosen by such company introducing a new drug product, the price chosen could be challenged by the PMPRB pursuant to the PMPRB initiating an investigation and possibly even an oral tribunal hearing before a panel comprising PMPRB Board Members. If the price charged is ultimately deemed excessive, a fine may be levied against the Company for an amount deemed to be in excess of the allowable price determined by the hearing panel or the Company may enter into a Voluntary Compliance Undertaking with PMPRB and reduce the price of the product and repay “excess revenues” accrued due to the price of the product exceeding that deemed by the PMPRB to be the maximum allowable price.  Drug products that have no patents are not subject to the PMPRB’s jurisdiction.

 

European Union Regulatory Overview

 

Before a medicinal product can be supplied or marketed in the EU, it must first be granted a marketing authorization. There are three routes by which this may be achieved: (1) the centralized procedure whereby a single European license is granted by the European Commission permitting the supply of the product in question throughout the EU, Iceland, Norway and Lichtenstein; (2) the decentralized procedure; or (3) the mutual recognition procedure, whereby, in the case of (2) and (3), the views of one national authority (Reference Member State) are “recognized” by other authorities (Concerned Member States) when conducting their reviews. The decentralized procedure applies if the medicinal product in question has not yet received a marketing authorization in any member state at the time of the application, whereas the mutual recognition procedure applies to a currently approved medicinal product. The decentralized and mutual recognition processes lead to individual marketing authorizations in each member state for the supply of products in that country only. The centralized route is compulsory for certain products, including

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biotechnology products, and is optional for certain so-called “high technology” products and products containing an entirely new active substance (apart from those medicinal products containing a new active substance for treatment of specified diseases listed at paragraph 3 of the Annex to Regulation (EC) No 726/2004, which come within the compulsory centralized procedure). All products which are not authorized by the centralized route must be authorized by the decentralized or mutual recognition procedures unless the product is designed for use in a single country in which case a National Application can be made.

 

In making an application for a new medicinal product not governed compulsorily by the centralized procedure, typically use will be made of the decentralized procedure although the mutual recognition procedure would be used if a marketing authorization were first secured in a Reference Member State. The procedural steps for the decentralized procedure and the mutual recognition procedure are governed by Directive 2001/83/EC, as amended, and are described in the Notice to Applicants, Volume 2A Chapter 2—Mutual Recognition (updated version – February 2007). The procedures provide for set time periods for each process (decentralized – 120 days (if consensus is reached between all Concerned Member States, otherwise it can take longer); mutual recognition - 210 days), but if consensus is not reached between all the Concerned Member States and the Reference Member State in that time, the application is referred to arbitration through the Co-ordination Group for Mutual Recognition and Decentralized Procedure (“CMD”), with subsequent referral to the Committee for Human Medicinal Products (“CHMP”). If a referral is made, the procedure is suspended, and marketing of the product would only be possible in those EU member states in which the product has been approved (prior to the conclusion of the referral procedure) by way of the mutual recognition procedure, unless the individual member state considers that the product poses a risk to public health and may therefore suspend the marketing of the product in its territory. The opinion of the CMD/CHMP, which is binding, could support or reject the objections or alternatively reach a compromise position acceptable to all EU countries concerned. The arbitration procedure may require the delivery of additional data. Once granted, any Marketing Authorization (“MA”) remains subject to pharmacovigilance and all competent authorities have the power to vary, suspend or revoke an MA on grounds of safety.  

 

Pricing and Reimbursement

 

As pressures for cost containment increase, particularly in the United States, Canada and the EU, there can be no assurance that the prices we can charge for our products will be as favorable as historical pharmaceutical product prices. Reimbursement by government, private insurance organizations and other healthcare payors has become increasingly important, as has the listing of new products on large formularies, such as those of pharmaceutical benefit providers and group buying organizations. The failure of one or more products to be included on formulary lists, or to be reimbursed by government or private insurance organizations, could have a negative impact on our results of operation and financial condition.

 

Future Legislation or Administrative Action

 

The extent of U.S., Canadian, EU and other foreign government regulation which might result from future legislation or administrative action cannot be accurately predicted. Legislative initiatives may impose additional regulatory requirements on us and may impact approval of our drugs or our marketing plans. The actual effect of these and other developments on our business is uncertain and unpredictable.

 

Other Laws and Regulations

 

The Company’s operations are or may be subject to various federal, provincial, state and local laws, regulations and recommendations relating to the marketing of products and relationships with treating physicians, data protection, safe working conditions, laboratory and manufacturing practices, the experimental use of animals, patient safety, the export of products to certain countries and the purchase, storage, movement, use and disposal of hazardous or potentially hazardous substances. Although we believe our safety procedures comply with the standards prescribed by federal, provincial, state and local regulations, the risk of contamination, injury or other accidental harm cannot be eliminated completely. In the event of an accident, we could be held liable for any damages that result. The amount of such damages could have a materially adverse effect on our results of operations and financial condition.

 

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Significant Customers

 

Product revenues, net

 

For the year ended December 31, 2017, our product revenues, net were concentrated among four significant pharmaceutical customers of the Company as follows:  McKesson Pharmaceutical – 31% , Shoppers Drug Mart Inc. –14%, Cardinal Health – 12% and Kohl & Frisch –11%.  For the year ended December 31, 2016, our product revenues, net were concentrated among three significant pharmaceutical customers of the Company as follows: McKesson Pharmaceutical – 38.5%, Shoppers Drug Mart Inc. – 19.0% and Kohl & Frisch – 14.8%.  

 

Management believes these concentrations are normal and customary in the pharmaceutical business. These are well-known and respected customers that have a solid track record of paying all outstanding amounts owing on time. The profile of our customers will continue to change prospectively as the geographic profile of our product revenues changes.

 

Other revenues

 

Other revenues were primarily concentrated among the Toprol-XL Franchise, which revenues were recorded net of related cost similar to a royalty arrangement under a transition services agreement with AstraZeneca from its acquisition date on October 31, 2016 through December 31, 2017, and Vimovo royalties from Horizon and AstraZeneca.

 

Segments and Geographic Information

 

We have one reporting segment. For information regarding revenue and other information regarding our results of operations, including geographic segment information, for each of our last three fiscal years, please refer to our consolidated financial statements and Note 14, “Segment Information”, in the accompanying notes to our consolidated financial statements.

 

Employees

 

As of March 1, 2018, the Company had a total of 164 employees, all of which are full-time employees. Of these, 111 employees are in sales and marketing and the remainder are in management and administration positions. Our employees are not represented by any collective bargaining unit, and we believe our relations with our employees are good.

 

Available Information

 

We maintain a website at www.aralez.com and will make available free of charge through this website our Annual Reports on Form 10-K, our Quarterly Reports on Form 10-Q, our Current Reports on Form 8-K, our Proxy Statements on Schedule 14A, and amendments to the foregoing filed with, or furnished to, the SEC as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Except for the documents specifically incorporated by reference into this Annual Report on Form 10-K, information contained on our website or that can be accessed through our website is not incorporated by reference into this Annual Report on Form 10-K. You may also read and copy any materials we file with the SEC at the SEC’s Public Reference Room that is located at 100 F Street, N.E., Room 1580, NW, Washington, DC 20549. Information about the operation of the Public Reference Room can be obtained by calling the SEC at 1-800-SEC-0330 or 1-202-551-8090.

 

We are also required to file reports and other information with the securities commissions in all provinces in Canada, other than Quebec. You are invited to read and copy any reports, statements or other information, other than confidential filings, that we file with the provincial securities commissions (excluding the Autorité des marchés financiers). These filings are also electronically available from the Canadian System for Electronic Document Analysis and Retrieval (www.sedar.com), the Canadian equivalent of the SEC’s electronic document gathering and retrieval system.

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ITEM 1A. RISK FACTORS

 

Certain factors may have a material adverse effect on our business, financial condition and results of operations, and you should carefully consider them. Accordingly, in evaluating our business, we encourage you to consider the following discussion of risk factors in its entirety, in addition to other information contained in this Annual Report on Form 10-K, as well as our other public filings with the SEC and securities regulatory authorities in Canada. The risks and uncertainties described below are those we currently believe to be material, but they are not the only ones we face. If any of the following risks, or any other risks and uncertainties that we have not yet identified or that we currently consider not to be material, actually occur or become material risks, our business and financial condition could be materially and adversely affected.

 

Risks Related to Our Business

 

We have incurred losses since inception and we may continue to incur losses for the foreseeable future.

 

We have a limited operating history and even less history operating as a combined organization following the Merger. For the fiscal years ended December 31, 2017 and 2016, we had net losses of approximately $125.2 million and $103.0 million, respectively. Our ability to receive product revenue from the sale of products is dependent on a number of factors, principally the successful commercialization of our products. We expect that the amount of our operating losses will fluctuate significantly from quarter to quarter principally as a result of increases and decreases in any development efforts, the timing and amount of payments that we may pay to, or receive from, others and the timing of our commercial expenses, including increased expenses in connection with the commercialization of our products and other factors which are beyond our control. If our licensed or marketed products do not perform well in the marketplace, our revenue will be impacted and our business could be materially harmed.

 

We have had limited product revenues and other sources of revenues to date and new sources of revenue have only just been approved or acquired. Even if we achieve profitability in the future, we cannot be certain that we will sustain profitability, which would depress the market price of our common shares and could cause our investors to lose all or a part of their investment.

 

Our ability to become profitable depends upon our ability to generate revenues from sales of our products. New sources of product revenue have only recently been approved, in the case of Blexten in Canada in April 2016, or acquired by the Company, in the case of Zontivity in the United States and Canada and the Toprol-XL Franchise in the United States, which products were acquired in September and October 2016, respectively. In addition, Aralez Canada only acquired Fibricor in May 2015. The ability of such products to generate revenues depends on a variety of factors, including the success of our commercialization efforts and competition in applicable markets. Product revenue for products which we license out is dependent upon the commercialization efforts of our partners. One of our primary sources of revenue to date is the royalty payments that we may receive in connection with the commercialization of Vimovo by AstraZeneca, outside of the United States (excluding Japan), and Horizon in the United States. In the event that AstraZeneca, Horizon or any other third-party with future commercialization rights to any of our products or product candidates fails to adequately commercialize those products or product candidates because it lacks adequate financial or other resources, decides to focus on other initiatives or otherwise, our ability to successfully commercialize our products or product candidates in the applicable jurisdictions would be limited, which would adversely affect our business, financial condition, results of operations and prospects. In addition, our ability to generate future revenues depends in part on our success in:

 

·

commercialization of our existing products and any other product candidates for which we obtain approval or that we acquire; and

 

·

developing, acquiring or in-licensing and commercializing other products or product candidates in addition to our current products.

 

Even if we do generate additional product sales, we may not be able to sustain profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the market price of our common shares and could impair our ability to raise capital, expand our business, diversify our product offerings or continue our operations.

 

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We have substantial indebtedness and  any failure to meet our debt service obligations would have a material adverse effect on our business, financial condition, cash flows and results of operation and could cause the market value of common shares to decline.

As of December 31, 2017, we have total liabilities of $438.3, including $200.0 million outstanding under that certain Second Amended and Restated Debt Facility Agreement (the “Facility Agreement”), dated December 7, 2015, among Aralez Pharmaceuticals Inc., Pozen, Aralez Canada (“the Credit Parties”) and certain lenders party thereto, which was borrowed in connection with our acquisitions of the Toprol-XL Franchise and Zontivity, and $75.0 million in outstanding convertible debt.

Having a substantial amount of leverage may have important consequences, including:

·

requiring a substantial portion of cash flow from operations to be dedicated to servicing our indebtedness, thereby reducing the ability to use cash flow from our operations to fund operations, capital expenditures, and future business opportunities;

·

limiting the ability to obtain additional financing for working capital, capital expenditures, product and service development, debt service requirements, acquisitions, and general corporate or other purposes at reasonable rates, which is vital to our business;

·

increasing the risks of adverse consequences resulting from a breach of any indebtedness agreement, including, for example, a failure to make required payments of principal or interest due to failure of our business to perform as expected;

·

increasing vulnerability to general economic and industry conditions;

·

restricting the ability to make strategic acquisitions or requiring non-strategic divestitures;

·

subjecting our operations to restrictive covenants that may limit operating flexibility; and

·

placing our operations at a competitive disadvantage compared to competitors that are less highly leveraged.

Our ability to satisfy our debt obligations will depend principally upon our future operating performance. As a result, prevailing economic conditions and financial, business and other factors, many of which are beyond our control, may affect our ability to make payments on our debt. If we do not generate sufficient cash flow to satisfy our debt service obligations, we may have to undertake alternative financing plans, such as refinancing or restructuring our debt, cost savings initiatives, proceeds-generating transactions, reducing or delaying capital investments or seeking to raise additional capital. Our ability to restructure or refinance our debt will depend on the capital markets and our financial condition at such time. Any refinancing of our debt could be at higher interest rates and may require us to comply with more onerous covenants, which could further restrict our business operations. Our inability to generate sufficient cash flow to satisfy our debt service obligations or to refinance our obligations on commercially reasonable terms could have a material adverse effect on our business, financial condition, cash flows and results of operations and could cause the market value of our common shares to decline.

 

 

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Our Operations have consumed substantial amounts of cash since inception.  If our operations do not produce the cash flow expected, our business, financial condition, cash flows and results of operations could be materially and adversely affected.

 

Our principal sources of liquidity are cash generated from the operating income of Aralez Canada; sales from the Toprol-XL Franchise, Zontivity, and Fibricor and its authorized generic; cash generated from the royalty payments received from our commercialization partners for net sales of Vimovo; and the financings completed on February 5, 2016 and October 31, 2016. Our principal liquidity requirements are for working capital; our debt service requirements; operational expenses; commercialization activities for products, including Zontivity, the Toprol-XL Franchise, Fibricor and our Canadian product portfolio, and product candidates; contractual obligations, including any royalty and milestone payments that will or may become due; and capital expenditures. 

 

As of December 31, 2017, we had an aggregate of $28.9 million in cash and cash equivalents.  Since the Merger in February 2016, we have incurred significant net losses. For the year ended December 31, 2017, we had a net loss of approximately $125.2 million. Our net cash used in our operating activities was $28.8 million during the year ended December 31, 2017. Our ability to become profitable and/or to generate positive cash from operations depends upon, among other things, our ability to generate revenues from sales of our products and prudently manage our expenses. New sources of product revenue have only recently been approved, in the case of Blexten in Canada, or acquired, in the case of Zontivity in the United States and Canada and the Toprol-XL Franchise in the United States. If we do not generate sufficient product revenues, or prudently manage our expenses, our business, financial condition, cash flows and results of operations could be materially and adversely affected and we may be unable to continue as a going concern.

 

During 2017, we announced and/or implemented a number of cost savings initiatives designed to streamline our business, deliver profitability and extend our cash runway. The cost-savings initiatives announced and/or implemented in 2017 are expected to result in a leaner and more effective performance-oriented operating model.  These cost savings initiatives included a 32% reduction in our U.S. sales force and realignment of certain financial resources to support the launch of Zontivity, together with a significant decrease in marketing spend on Yosprala and other cost reductions across the business to attain profitability and enhance our liquidity position.  In addition, we are continuing to explore and evaluate strategic business opportunities to enhance longer term liquidity, including by any combination of debt refinancing, additional cost savings initiatives and/or proceeds-generating transactions. There can be no assurances that these other initiatives will be available on reasonable terms, or at all. If we are not successful with respect to the initiatives described above, or if our future operations fail to meet current expectations, our projected future liquidity may be limited, which could materially and adversely affect our business, financial condition, cash flows, results of operations and ability to continue as a going concern.

 

We have had and may continue to experience negative cash flows from operations. 

 

We have made significant up-front investments in sales and marketing and general and administrative expenses in order to rapidly develop and expand its business. We are currently incurring expenditures related to our operations that have generated a negative operating cash flow. Operating cash flow may decline in certain circumstances, many of which are beyond our control. There is no assurance that sufficient revenues will be generated in the near future. If we continue to incur such significant future expenditures for sales and marketing and general and administrative expenses, we may continue to experience negative cash flow until we reach a sufficient level of sales with positive gross margins to cover operating expenses. An inability to generate positive cash flow until we reach a sufficient level of sales with positive gross margins to cover operating expenses or raise additional capital on reasonable terms could materially and adversely affect our business, financial condition, cash flows and results of operations.

 

The timing of the milestone and royalty payments we are required to make to third parties could adversely affect our cash flows and results of operations.

We are party to various agreements pursuant to which we are obligated to make milestone payments or pay royalties to third parties.  For example, we are required to pay to AstraZeneca milestone payments in eight quarterly installments of approximately $5.6 million beginning in the second quarter of 2019 related to our acquisition of the Toprol-XL Franchise.  We may become obligated to make a milestone or other payment at a time when we do not have sufficient funds to make such payment, or at a time that would otherwise require us to use funds needed to continue to

25


 

operate our business, which could curtail our operations, necessitate a scaling back of our commercialization and marketing efforts or cause us to seek funds to meet these obligations on terms unfavorable to us.

 

 

 

We may need additional funding and may not have access to capital. If we are unable to raise capital when needed, we may need to delay, reduce or eliminate our product development or commercialization efforts and our business, financial condition, cash flows and results of operations could be materially and adversely affected.

 

In the future, we may need to raise additional funds to execute our evolving business strategy. We have incurred losses from operations since inception and we may continue to incur additional operating losses. Our actual capital requirements will depend upon numerous factors, including:

 

·

our ability to commercialize or arrange for the commercialization of our products;

 

·

the costs of commercialization of our products;

 

·

the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

 

·

the effect of competing technological and market developments;

 

·

generic competition with respect to our products;

 

·

the timing of our payment or receipt, as applicable, of milestone payments and royalties under collaborative, license, acquisition or other agreements;

 

·

the effect of changes and developments in, or termination of, our collaborative, license, acquisition and other relationships;

 

·

the terms and timing of any additional collaborative, license, acquisition and other arrangements that we may establish; and

 

·

the ability to acquire or in-license additional complementary products or products that augment our current product portfolio.

 

We may need to raise additional capital if we choose to expand our commercialization or development efforts more rapidly than we presently anticipate, if we develop, acquire or in-license additional products or acquire companies or if our revenues do not meet expectations. In addition, our expenses might increase beyond currently expected levels if we decide to, or any regulatory agency requires us to, conduct additional clinical trials, studies or investigations for any of our product candidates, including in connection with the consideration, or reconsideration, of our regulatory filings for our product candidates. We began commercializing Zontivity in the United States without a commercial partner and our expenses have increased and may continue to increase relative to prior years, notwithstanding our efforts to decrease costs, as we continue our commercialization efforts with respect to our current and any future products.

 

We may be unable to raise additional funds when we desire to do so due to unfavorable market conditions in our industry, or generally, or due to other unforeseen developments in our business. Further, we cannot be certain that additional funding will be available on acceptable terms, or at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of one or more of our products or product candidates, or delay, cut back or abandon our plans to grow the business through acquisition or in-licensing. We also could be required to:

 

·

seek collaborators for one or more of our current or future products or product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available; or

 

·

sell, relinquish or license on unfavorable terms our rights to technologies, products or product candidates that we otherwise would seek to develop or commercialize ourselves; or

26


 

 

·

engage in additional cost-savings initiatives and/or proceeds-generating transactions.

 

Any of the above events could significantly harm our business, financial condition and prospects and cause the price of our common shares to decline.

 

Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish intellectual property or other rights to our products or product candidates.

 

Additional capital may be needed in the future to continue our planned operations. We may seek additional capital through a combination of private and public equity offerings, debt financings, receivables or royalty financings, strategic partnerships and alliances, licensing arrangements or divestitures of assets. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existing shareholders will be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of our shareholders. Debt, receivables and royalty financings may be coupled with an equity component, such as warrants to purchase shares, or existing debt refinanced or amended, each of which could also result in dilution of our existing shareholders’ ownership. The incurrence of additional indebtedness would result in increased fixed payment obligations. In addition, the incurrence of new debt or refinancing of existing debt could result in certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.

 

 

Covenants and financial performance thresholds imposed by the Facility Agreement restrict our business and operations in many ways and if we do not effectively manage our covenants and financial performance thresholds, our financial conditions and results of operations could be adversely affected.

 

The Facility Agreement imposes various covenants that limit our ability and/or our subsidiaries’ ability to, among other things:

 

·

consolidate or merge with or into another person;

 

·

enter into certain transactions with affiliates;

 

·

pay dividends or distributions;

 

·

create, incur or suffer liens;

 

·

create, incur, assume guarantee or be liable with respect to indebtedness;

 

·

acquire assets or transfer products or material assets; and

 

·

issue equity securities senior to our common shares or convertible or exercisable for equity securities senior to our common shares.

 

The covenants imposed by the Facility Agreement and our obligations to service our outstanding debt:

 

·

limit our ability to borrow additional funds for working capital, capital expenditures, acquisitions or other general business purposes;

 

·

limit our ability to use our cash flow or obtain additional financing for future working capital, capital expenditures, acquisitions or other general business purposes;

 

·

may require us to use a substantial portion of our cash flow from operations to make debt service payments;

 

·

limit our flexibility to plan for, or react to, changes in our business and industry;

 

·

place us at a competitive disadvantage compared to our less leveraged competitors; and

27


 

 

·

increase our vulnerability to the impact of adverse economic and industry conditions.

 

If we are unable to successfully manage the limitations and decreased flexibility on our business due to our debt obligations, we may not be able to capitalize on strategic opportunities or grow our business to the extent we would be able to without these limitations. Our failure to comply with any of the covenants could result in a default under the Facility Agreement, which could permit the required lenders to declare all or part of any outstanding loans to be immediately due and payable.

 

In addition, in connection with the acquisition of the Toprol-XL Franchise, the Facility Agreement was amended to include additional financial performance thresholds, including a minimum adjusted EBITDA threshold (beginning in the third quarter of 2018) and a minimum specified revenue threshold relating to net sales of the Toprol-XL Franchise received by the Company. In the event of the failure to meet both such additional financial performance thresholds, the lenders thereunder may elect to have the then outstanding principal balance of certain term loans under the Facility Agreement amortize quarterly through the maturity thereof.

 

Generic competition to our products could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

 

Upon the expiration or loss of patent protection for our products, or upon the “at-risk” launch (despite pending patent infringement litigation against the generic product) by a generic competitor of a generic version of our products, we can lose a significant portion of sales of that product, or royalty revenue in the case of out-licensed products, in a very short period, which could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline. Furthermore, for products where a generic market already exists, there may be increased generic competition from current or new entrants to the generic market.

 

In addition, the amount of generic competition may impact our milestone and royalty obligations under various agreements, which may have an adverse effect on our business. 

 

A significant amount of our revenues come from our Toprol-XL Franchise and increased generic competition to the Toprol-XL Franchise could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

 

Toprol-XL was first approved by the FDA in 1992 and is no longer subject to patent protection in the United States.   There are several suppliers of generic versions of Toprol-XL (metoprolol succinate), including a new supplier approved by the FDA in February 2018.  In addition, other generic manufacturers may enter the market for metoprolol succinate. The FDA has also recently announced a new policy to expedite the review of generic drug applications in certain circumstances, which could have the effect of facilitating additional generic competition for the Toprol-XL Franchise.  A significant portion of our revenue is derived from the Toprol-XL Franchise and if additional generic competitors enter the market for metoprolol succinate or if there is additional price erosion in the current market, there could be a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

 

Our ability to generate revenues from our products is subject to attaining significant market acceptance among physicians, patients, third-party payors and the medical community.

 

Our current products, and other products or product candidates that we may develop, acquire or in-license, may not attain market acceptance among physicians, patients, third-party payors or the medical community. Even if a product displays a favorable efficacy and safety profile in clinical trials, market acceptance of a product will not be known until after it is launched or relaunched and a product may not generate the revenues that we anticipate. The degree of market acceptance will depend upon a number of factors, including:

 

·

the acceptance by doctors and other medical specialists of our products as an alternative to other therapies;

 

·

the receipt and timing of regulatory approvals;

 

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·

the timing of market introduction of our products as well as competitive drugs;

 

·

the availability of coverage and adequate reimbursement and pricing from government and other third-party payors;

 

·

the price of our products, both in absolute terms and relative to alternative therapies;

 

·

the indications for which the product is approved;

 

·

the rate of adoption by healthcare providers;

 

·

the rate of product acceptance by target patient populations;

 

·

recommendations by pharmacists regarding our products relative to alternative products;

 

·

the availability of alternative therapies;

 

·

the extent and effectiveness of marketing efforts by our collaborators, third-party distributors and agents;

 

·

the strength of sales, marketing and distribution support;

 

·

the existence of adverse publicity regarding our products or similar products and the pricing of pharmaceutical products generally;

 

·

historical experience with a product or similar products and market perception of a product or similar products;

 

·

the efficacy of our products compared to alternative therapies; and

 

·

the extent and severity of side effects as compared to alternative therapies.

 

Risks related to the factors above are particularly relevant to our recent product launches or relaunches, including Blexten (launched in Canada in December 2016) and Zontivity (fully relaunched in the United States in June 2017). The commencement of commercialization of these products by Aralez in a short period of time has and will continue to require significant efforts from us and the devotion of substantial resources as we will need to, among other things, establish the commercial infrastructure necessary to support these products. With respect to Zontivity, the product was previously launched and existing market perception may make it challenging for Aralez to successfully relaunch and commercialize the product. 

 

For our products, we depend on reimbursement from third-party payors and a failure to obtain coverage or reduction in the extent of reimbursement could reduce our product sales and revenue.

 

Sales of our products are dependent, in part, on the availability and extent of reimbursement from government health administration authorities, private health insurers and other organizations and our continued participation in such programs. These entities may refuse to provide coverage and reimbursement, determine to provide a lower level of coverage and reimbursement than anticipated, or reduce previously approved levels of coverage and reimbursement, including in the form of higher mandatory rebates or modified pricing terms.

 

In certain countries, including Canada, where we sell or are seeking or may seek to commercialize our products, pricing, coverage and level of reimbursement of prescription drugs are subject to governmental control. We may be unable to timely or successfully negotiate coverage, pricing, and reimbursement on terms that are favorable to us, or such coverage, pricing, and reimbursement may differ in separate regions in the same country. A significant reduction in the amount of reimbursement or pricing for our products in one or more countries may reduce our profitability and adversely affect our financial condition. Certain countries establish pricing and reimbursement amounts by reference to the price of the same or similar products in other countries. If coverage or the level of reimbursement is limited in one or more countries, we may be unable to obtain or maintain anticipated pricing or reimbursement in current or new territories. In

29


 

the United States, the EU, and elsewhere, there have been, and we expect there will continue to be, efforts to control and reduce healthcare costs. In the United States, for example, the price of drugs has come under intense scrutiny by the President, U.S. Congress and other government officials and political candidates. Third-party payors decide which drugs they will pay for and establish reimbursement and co-payment levels. Government and other third-party payors are increasingly challenging the prices charged for healthcare products, examining the cost effectiveness of drugs in addition to their safety and efficacy, and limiting or attempting to limit both coverage and the level of reimbursement for prescription drugs.

 

Changes in government regulations or private third-party payors’ reimbursement policies may reduce reimbursement for our products and adversely affect our future results. Our commercial success depends on obtaining and maintaining reimbursement at anticipated levels for our products. It may be difficult to project the impact of evolving reimbursement mechanics or the willingness of payors to cover our products. If we are unable to obtain or maintain coverage, or coverage is reduced in one or more countries, our pricing may be affected and our product sales, results of operations or financial condition could be harmed. In addition, as the price of drugs undergoes more scrutiny, there is the possibility of retroactive price adjustments or coverage or penalties for prices that may be deemed excessive. If any such actions were applied to the Company, our business, financial condition and results of operations could be harmed.

 

Failure to be included in formularies, or restrictions on drugs included in formularies, developed by managed care organizations, governments, hospitals and other organizations may negatively impact the utilization of our products, which could harm our market share and negatively impact our business, financial condition and results of operations.

 

Managed care organizations and other third-party payors try to negotiate the pricing of medical services and products to control their costs. Managed care organizations and pharmacy benefit managers typically develop formularies to reduce their cost for medications. Formularies can be based on the prices and therapeutic benefits of the available products. Due to their lower costs, generic products are often favored. The breadth of the products covered by formularies varies considerably from one managed care organization to another, and many formularies include alternative and competitive products for treatment of particular medical conditions. Failure to be included on such formularies, failure to achieve favorable formulary status, restrictions on drugs included on formularies such as prior authorizations, step edits or other limitations, or delays in implementing changes to formulary status, may negatively impact the utilization of our products. If our products are not included within an adequate number of formularies or adequate reimbursement levels are not provided, or if those policies increasingly favor generic products, our market share and gross margins could be harmed, as could our business, financial condition, results of operations and cash flows.

 

We currently depend and will in the future depend on third parties to manufacture our products and product candidates. If these manufacturers fail to meet our requirements or any regulatory requirements, the sales of our products may be harmed and commercialization and development of our products and any candidates will be delayed.

 

We do not have, and have no plans to develop, the internal capability to manufacture our products or product candidates. We rely upon third-party manufacturers and our partners to supply us with the commercial and developmental supplies of our products and product candidates. For example, in connection with the acquisition of Zontivity in 2016, Merck agreed to supply the product to us for a period of up to three years following the closing of such acquisition (although the packaging component has been transferred to a third party provider), after which we must establish a new manufacturer for the product. With respect to the acquisition of the Toprol-XL Franchise in 2016, AstraZeneca agreed to supply such products to us for a period of at least 10 years following the closing of such acquisition. The manufacturing facilities of our third-party manufacturers may be inspected from time to time and need to be found to be in full compliance with cGMP, quality system management requirements or similar standards, and we may not be able to ensure that such third parties comply with these obligations. The failure of our contract manufacturers to comply with cGMP regulations, quality system management requirements or similar regulations could result in enforcement action by the FDA or its foreign counterparts, including, but not limited to, warning letters, fines, injunctions, civil or criminal penalties, recall or seizure of products, total or partial suspension of production or importation, suspension or withdrawal of regulatory approval for approved or in-market products, refusal of the government to renew marketing applications, licenses or approve pending applications or supplements, suspension of ongoing clinical trials, imposition of new manufacturing requirements, closure of facilities and criminal prosecution. These enforcement actions could lead to a delay or suspension in production. Furthermore, the failure of our ingredient

30


 

or material suppliers to comply with regulatory requirements can impact our ability to supply the market with our products.

 

There is no guarantee that manufacturers and API or other material suppliers that enter into commercial supply contracts with us will be financially viable entities going forward, or will not otherwise breach or terminate their agreements with us. If we do not have the necessary commercial supply contracts, or if any of our current or future third party manufacturers or API suppliers are unable to satisfy our requirements or meet any regulatory requirements, and we are or will be required to find alternative sources of supply, there may be additional costs and delays in product development and commercialization of our product candidates or we may be required to comply with additional regulatory requirements.  In addition, certain of our distribution agreements may contain “failure to supply” or similar provisions that may subject us to costs and penalties in the event we do not meet our supply obligations thereunder.  Such costs and penalties may be substantial and may not be adequately reimbursed by our suppliers or at all. 

 

In the event that suppliers of a product, ingredient or any materials we need to manufacture or package our products or licensed products are not available or not for sale at the time we need such ingredient or material in order to meet our required delivery schedule or on commercially reasonable terms, then we could be at risk of a product shortage or stock-out. We rely on our suppliers in many cases to ensure the adequate supply of ingredients, APIs and packaging material and for the timely delivery of orders placed by us. Should we experience a shortage in supply of a product, licensed product, or API, sales of such product or licensed product could be harmed or reduced and our ability to generate revenues from such product or licensed product may be impaired.

 

Our reliance on collaborations with third parties to develop, manufacture and commercialize our products is subject to inherent risks and may result in delays in product development and lost or reduced revenues, restricting our ability to commercialize our products and adversely affecting our profitability.

 

We depend upon collaborations with third parties to develop, manufacture and/or supply our products and, in some cases, we depend substantially upon third parties to commercialize these products. As a result, our ability to develop, obtain regulatory approval of, manufacture and commercialize our existing and possibly future products and product candidates depends upon our ability to maintain existing, and enter into and maintain new, contractual and collaborative arrangements with others. We also engage and/or may in the future engage third party manufacturers and clinical trial investigators.

 

In addition, the identification of new compounds or product candidates for development has led us in the past, and may continue to require us, to enter into license or other collaborative agreements with others, including pharmaceutical companies and research institutions. Such collaborative agreements for the acquisition of new compounds or product candidates would typically require us to pay license fees, make milestone payments and/or pay royalties. For products we out-license, these agreements may result in our revenues being lower than if we developed and commercialized our products or product candidates ourselves and in our loss of control over the development of our product candidates.

 

Contractors or collaborators may have the right to terminate their agreements with us after a specified notice period for any reason or upon a default by us. For example, AstraZeneca, with respect to Vimovo, and Pernix, with respect to Treximet, have the right to terminate their respective agreements with us upon a 90-day notice for any reason. Licensees may have the right to reduce their payments to us under their agreements. For example, AstraZeneca and Horizon, with respect to Vimovo, and Pernix, with respect to Treximet, have the right to reduce the royalties on net sales of products payable to us under their respective agreements if generic competitors enter the market and attain a pre-determined share of the market for products marketed under the agreements, or if they must pay a royalty to one or more third parties for rights they license from those third parties to commercialize products marketed under the agreements. Further, our current or future collaboration agreements may terminate, or our collaborators may have the right to terminate their agreements with us or reduce or eliminate their payments to us under these agreements, based on our inability to obtain, or delays in obtaining, regulatory approval for our product candidates, certain business performance criteria or our contract manufacturers’ inability to manufacture our products or to supply the sufficient quantities of our products to meet market demand. For example, we distribute the Toprol-XL AG through a distribution and supply agreement with Lannett Company, Inc., which agreement expires at the end of 2020 but may be terminated by either party under certain circumstances, including performance measures. If our current or future collaborators exercise termination rights they may have, or if the agreements terminate because of delays in obtaining regulatory approvals, business performance or for other reasons, and we are not able to establish replacement or additional research and

31


 

development collaborations or licensing or commercialization arrangements, we may not be able to effectively develop and/or commercialize our products or product candidates. Moreover, any future collaborations or license arrangements we may enter into may not be on terms favorable to us.

 

Collaborators may decide not to continue marketing our products in certain countries, as was the case when AstraZeneca informed us that, after a strategic business review, it had decided to cease promotion and sampling of Vimovo by the end of the third quarter of 2013 in certain countries, including the United States and all countries in Europe, other than Spain and Portugal, which have pre-existing contractual relationships with third parties. In addition, collaborators may decide to assign their rights under our agreement to third parties. For example, we had a collaboration agreement with GSK for the development and commercialization of certain triptan combinations using our MT 400 technology, including Treximet, in the United States, and GSK subsequently divested all of its rights, title and interest to develop, commercialize and sell the licensed products in the United States to Pernix.

 

In addition, Toprol-XL was sold by AstraZeneca on our behalf under a transition services agreement from the acquisition date through December 31, 2017. In connection therewith we establish reserves based on estimates of amounts for rebates, chargebacks, discounts, distributors fees, and returns and allowances earned or to be claimed on the related sales based on information provided by AstraZeneca in accordance with the Toprol-XL Asset Purchase Agreement.  We believe that the reserves we have established are reasonable based upon current facts and circumstances and contractual terms. Applying different judgments or interpretations to the same facts and circumstances could result in the estimated amount for reserves to vary. If actual results vary with respect to our reserves, we may need to adjust our estimates, which could have a material effect on our results of operations in the period of adjustment.

 

Other risks associated with our collaborative and contractual arrangements with others include the following:

 

·

we may not have day-to-day control over the activities of our contractors or collaborators;

 

·

our collaborators may fail to defend or enforce patents they own on compounds or technologies that are incorporated into the products we develop with them;

 

·

third parties may not fulfill their regulatory or other obligations;

 

·

we may not realize the contemplated or expected benefits from collaborative or other arrangements;

 

·

if any collaborator were to breach its agreement with us or otherwise fail to conduct collaborative activities in a timely or successful manner, the commercialization or product development of the affected product, product candidate or research program would be harmed, delayed or terminated;

 

·

our collaborators may be able to exercise control, under certain circumstances, over our ability to protect our patent rights under patents covered by the applicable collaboration agreement; and

 

·

disagreements may arise regarding a breach of the arrangement, the interpretation of the agreement, ownership of proprietary rights, clinical results or regulatory approvals.

 

These factors could lead to delays in the commercialization of our products and/or development of our product candidates or reduction in the milestone, royalty payments or profit sharing we receive from our collaborators, or could result in our not being able to commercialize our products. Further, disagreements with our contractors or collaborators could require or result in litigation or arbitration, which would be time-consuming and expensive. Our ultimate success may depend upon the success and performance on the part of these third parties. If we fail to maintain these relationships or establish new relationships as required, development of our product candidates and/or the commercialization of our products will be delayed or may never be realized.

 

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Our expense reduction initiatives, including our decision to reduce our U.S. sales force in April 2017 and the other cost savings initiatives we announced in April 2017 and on November 9, 2017, may impact our ability to maintain or increase our sales levels or successfully commercialize our products.  In addition, we may not realize the expected benefits of our initiatives to reduce costs across our operations.

Our ability to successfully commercialize our products depends in part on our sales and marketing resources, including sales personnel, dedicated to such efforts.  In April 2017, we announced a number of expense reduction initiatives, including a reduction in our U.S. sales force.  Each remaining sales representative is now responsible for a larger territory than prior to the reduction in force.  The sales force reduction could harm our ability to attract and retain qualified sales personnel.  The sales force reduction could also result in a lack of focus and reduced productivity among our remaining sales personnel.  We announced further cost savings initiatives on November 9, 2017 with respect to marketing spend, professional and consulting fees, and other departmental expenses and may explore additional cost savings initiatives in the future.   All of the foregoing may negatively impact the sales of our products.  Furthermore, the cost savings initiatives may not result in the anticipated improvements to profitability or our liquidity position.

In addition, we have incurred restructuring charges and may incur additional restructuring charges as we implement our cost saving initiatives and we may not realize some or all of the expected benefits from such initiatives.  There may also be significant disruptions in our operations now or in the future as a result of these initiatives, which may impact our business, financial condition or results of operations. 

If we make strategic acquisitions, we will incur a variety of costs and may fail to realize all of the anticipated benefits of the transactions or those benefits may take longer to realize than expected. We may be unable to identify, acquire, close or integrate acquisition targets successfully.

 

A  significant part of our business strategy includes acquiring and integrating complementary businesses, products, technologies or other assets, and forming strategic alliances and other business combinations, to help drive future growth. We may also in-license new products or compounds. Acquisitions or similar arrangements may be complex, time-consuming and expensive, and the process of negotiating the acquisition and integrating an acquired product, drug candidate, technology, business or company might result in operating difficulties and expenditures and might require significant management attention that would otherwise be available for ongoing development of our business, whether or not any such transaction is ever consummated. Moreover, we may never realize the anticipated benefits of any acquisition or forecasted sales may not materialize.

 

In addition, we may explore, pursue and/or negotiate transactions that are not ultimately completed and there are a number of risks, costs and uncertainties relating thereto.  For example, the market price of our common shares may reflect a market assumption that such transactions will occur, and a failure to complete such transactions could result in a negative perception by the market of the Company generally and a decline in the market price of our common shares.  In addition, many costs relating to such transactions may be payable by us whether or not such transactions are completed, which costs may be significant.

 

If an acquisition is consummated, the integration of the acquired business, product or other assets into the Company may also be complex and time-consuming and, if such businesses, products and assets are not successfully integrated, we may not achieve the anticipated benefits, cost-savings or growth opportunities. Potential difficulties that may be encountered in the integration process include the following: integrating personnel, operations, manufacturing technology and systems, while maintaining focus on selling and promoting existing and newly-acquired products; coordinating geographically dispersed organizations; distracting management and employees from operations; retaining existing customers and attracting new customers; maintaining the business relationships of the acquired company or that the company that previously owned such product has established, including with healthcare providers, third-party payors and distributors; and managing inefficiencies associated with integrating the operations of the Company.

 

Furthermore, we have incurred, and may incur in the future, restructuring and integration costs and a number of non-recurring transaction costs associated with these acquisitions, combining the operations of the Company and the acquired business and achieving desired synergies. These fees and costs may be substantial. Non-recurring transaction costs include, but are not limited to, fees paid to legal, financial, regulatory, manufacturing and accounting advisors, filing fees, transfer and other transaction-related taxes and printing costs. Additional unanticipated costs may be incurred in the integration of the businesses of the Company and the acquired business. There can be no assurance that the elimination of certain duplicative costs, as well as the realization of other efficiencies related to the integration of the acquired business, will offset the incremental transaction-related costs over time. Therefore, any net benefit may not be achieved in the near term, the long term or at all.

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Finally, these acquisitions and other arrangements, even if successfully integrated, may fail to further our business strategy as anticipated or to achieve anticipated benefits and success, expose us to increased competition or challenges with respect to our products or geographic markets, and expose us to additional liabilities associated with an acquired business, product, technology or other asset or arrangement. Any one of these challenges or risks could impair our ability to realize any benefit from an acquisition or arrangement after we have expended resources on them.

 

For example, in February 2016, we completed the acquisition of Aralez Canada, in September 2016, we completed the acquisition of the U.S. and Canadian rights to Zontivity, and in October 2016, we completed the acquisition of the U.S. rights to the Toprol-XL Franchise. Such transactions represent significant acquisitions for the Company and may expose us to a number of the risks identified above. We may face difficulties in connection with the integration of such businesses with the Company, which integration activities may be complex, time-consuming and disruptive to the operation of our business generally. In addition, the costs incurred in connection with integration activities may be more substantial than we anticipated and, as a result, may significantly reduce or even outweigh any benefits and efficiencies realized during our integration efforts.

 

We may also face challenges transferring the assets, such as contracts, regulatory requirements and technology, to the extent applicable, associated with such acquired businesses. In addition, we may not be successful in our commercialization efforts with respect to such businesses or face increased competition or costs with respect to the acquired products and, as a result, we may not be able to achieve all of the anticipated benefits of such transactions. Any of these factors could have a material adverse effect on our business, financial condition or results of operations or could decrease or delay the expected accretive effect of such transactions or cause the market value of our common shares to decline.

 

Failure to successfully acquire, license or develop and market additional product candidates or approved products would impair our ability to grow.

 

As part of our strategy, we may acquire, license or develop and market additional products and product candidates. The product candidates to which we allocate our resources may not end up being successful. In addition, because our internal research capabilities are limited, we may depend upon pharmaceutical, biotechnology and other researchers to sell or license products or technology to us. The success of this strategy depends partly upon our ability to identify, select, license and/or acquire promising pharmaceutical or other healthcare product candidates and products for Canada, the United States and elsewhere. Failure of this strategy would impair our ability to grow.

 

The process of proposing, negotiating and implementing a license or acquisition of a product candidate or approved product is lengthy and complex. Other companies, including some with substantially greater financial, marketing and sales resources, may compete with us for the license or acquisition of product candidates and approved products. We may devote resources to potential acquisitions or in-licensing opportunities that are never completed, or we may fail to realize the anticipated benefits of such efforts. We may not be able to acquire the rights to additional product candidates or approved products on terms that we find acceptable, or at all.

 

In addition, future acquisitions may entail numerous operational and financial risks, including:

 

·

exposure to unknown liabilities;

 

·

disruption of our business and diversion of management’s time and attention to develop acquired products or technologies;

 

·

incurrence of substantial debt, dilutive issuances of securities or depletion of cash to pay for acquisitions;

 

·

higher than expected acquisition and integration costs;

 

·

difficulty in combining the operations and personnel of any acquired businesses with our operations and personnel;

 

·

increased amortization expenses;

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·

increased or unanticipated costs;

 

·

failure of the acquired business to achieve expected financial results;

 

·

increased or unexpected competition with respect to the acquired business;

 

·

impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and

 

·

inability to motivate key employees of any acquired businesses.

 

Further, any unapproved product candidate that we acquire may require additional development efforts prior to commercial sale, including extensive clinical testing and approval by applicable regulatory authorities. All product candidates are prone to risks of failure typical of pharmaceutical product development, including the possibility that a product candidate will not be shown to be sufficiently safe and effective for approval by applicable regulatory authorities and thus will never make it to market.

 

Each of our products has a limited shelf life which could result in costs associated with inventory which exceeds the appropriate age limits.

 

Each of our products has a limited shelf life. Accordingly, product which exceeds the appropriate age limits may not be sold, may result in product returns and must be destroyed, which would have an adverse financial impact associated with the cost of writing off obsolete inventory.

 

We continue to evaluate the commercial opportunities for our current products and product candidates in connection with our development of a worldwide commercialization strategy. If we are unable to develop sales and marketing capabilities on our own, or through partnerships, we will not be able to fully exploit the commercial potential of our products and the costs of pursuing such a strategy may have a material adverse impact on our results of operations.

 

We continue to evaluate the commercial opportunities for our products and product candidates in connection with our development of a worldwide commercialization strategy. In June 2015, our Board of Directors appointed Adrian Adams as our new Chief Executive Officer and Andrew I. Koven as our new President and Chief Business Officer, each of whom has experience creating, leading and expanding pharmaceutical companies with marketing and sales capabilities. We have made significant expenditures to secure commercial resources to relaunch Zontivity in the United States and commercialize other existing products and significant expenditures may be required to support the commercialization of our current products or products we may acquire. Any failure, extended delay or inability to effectively operate in the marketplace alone or together with our partners could adversely impact our business. There can be no assurance that our sales and marketing efforts will generate significant revenues and costs required to pursue such a strategy may be prohibitive and/or have a material adverse impact on our results of operations. Events or factors that may inhibit or hinder our commercialization efforts include:

 

·

building and developing our own commercial team or playing a role in the commercialization with a partner will be expensive and time-consuming and will result in high cash burn or reduced profitability;

 

·

failure to acquire sufficient or suitable personnel to establish, oversee, or implement our commercialization strategy;

 

·

failure to recruit, train, oversee and retain adequate numbers of effective sales and marketing personnel;

 

·

failure to develop a commercial strategy ourselves or together with partners that can effectively reach and persuade adequate numbers of physicians to prescribe our products;

 

·

our or our partners’ inability to secure reimbursement at a reasonable price;

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·

unforeseen costs and expenses associated with creating or acquiring and sustaining an independent commercial organization;

 

·

incurrence of costs in advance of anticipated revenues and subsequent failure to generate sufficient revenue to offset additional costs; and

 

·

ability to fund our commercialization efforts alone or together with our partners on terms acceptable to us, if at all.

 

If we are unable to effectively train and equip our sales force, our ability to successfully commercialize our products will be harmed.

 

We are required to expend significant time and resources to train our sales force to be credible, compliant and persuasive in educating physicians to prescribe and pharmacists to dispense our products. In addition, we must train our sales force to ensure that a consistent and appropriate message about our products is being delivered to our potential customers. Our sales representatives may also experience challenges promoting multiple products when they call on physicians and their office staff. This is particularly true with respect to our products that have competing products prescribed to similar patients. If we are unable to effectively train our sales force and equip them with effective materials, including medical and sales literature to help them inform and educate potential customers about the benefits of our products and their proper administration and approved indications, our efforts to successfully commercialize our products could be put in jeopardy, which could have a material adverse effect on our financial condition, share price and operations.

 

Certain of our products may never be approved for commercial use in all desired jurisdictions. Failure to successfully commercialize our products or develop, gain approval of or commercialize our product candidates would adversely impact our financial condition and prospects.

 

We anticipate that a component of our success will depend on the successful commercialization of our products upon regulatory approval in territories where our products are not approved. Before we can market and sell our products in a particular jurisdiction, we need to obtain necessary regulatory approvals (from the FDA in the United States, Health Canada in Canada, EMA in the EU and from similar foreign regulatory agencies in other jurisdictions), and in some jurisdictions, reimbursement authorization. There are no guarantees that we or our commercialization partners will obtain approval in those countries where we wish to commercialize our products. Even if we or our commercialization partners obtain additional regulatory approvals, we may never generate significant revenues from any commercial sales of our products. These approvals may not be granted on a timely basis, if at all. Nor can any assurance be given that if such approval is secured, the approved labeling will not have significant labeling limitations, including limitations on the indications for which we can market a product, or require onerous risk management programs. Further, our current or future collaboration agreements may terminate, or require us to make certain payments to our collaborators, or our collaborators may have the right to terminate their agreements with us or reduce or eliminate their payments to us under these agreements, based on our inability to obtain, or delays in obtaining, regulatory approval for our product candidates. If we fail to successfully commercialize our current and future products, we may be unable to generate sufficient revenues to sustain and grow our business, and our business, financial condition and results of operations will be adversely affected.

 

In addition, if any development projects are not successful or are significantly delayed, we may not recover our investments in the product candidates and our failure to bring these product candidates to market on a timely basis, or at all, could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

 

We are dependent upon a small number of customers for a significant portion of our revenue, and the loss of or significant reduction in sales to these customers would adversely affect our results of operations.

 

We sell our products in the United States and Canada to a limited number of distributors. Under this distribution model, the distributors generally take physical delivery of product and generally sell the product directly to pharmacies or patients. In addition, certain of our products may be highly dependent on a small number of customers. We expect this significant distributor/customer concentration to continue for the foreseeable future. Our ability to generate and grow

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sales of our products will depend, in part, on the extent to which our distributors are able to provide adequate distribution of our products on pricing terms that are favorable to us. Although we believe we can find additional or replacement distributors, if necessary, the pricing terms of such arrangements may not be as favorable to us and our revenue during any period of disruption could suffer and we might incur additional costs. In addition, these distributors/customers are responsible for a significant portion of our net trade accounts receivable balances. The loss of any large distributor/customer, a significant reduction in sales we make to them, any cancellation of orders they have made with us, or any failure to pay for the products we have shipped to them could adversely affect our results of operations.

 

We may not be able to compete with treatments now being developed and marketed, or which may be developed and marketed in the future by other companies.

 

Our products and product candidates will compete with existing and new therapies and treatments. There are also likely to be numerous competitors that are engaged in the development of alternatives to our technologies and products, which could render our products, product candidates and technologies obsolete or non-competitive. For example, our primary competitors will likely include large pharmaceutical companies, biotechnology companies, universities and public and private research institutions. Some of these companies have greater research and development capabilities, experience, and manufacturing, marketing, financial and managerial resources than we do. Collaborations or mergers between large pharmaceutical or biotechnology companies with competing drugs and technologies could enhance our competitors’ financial, marketing and other resources. Accordingly, our competitors may succeed in developing competing drugs or technologies, obtaining patent protection, obtaining regulatory approval for products, commercializing products or gaining market acceptance more rapidly than we can. Any delays we encounter in obtaining regulatory approvals for our product candidates increases this risk.

 

The competition for Vimovo, and any PPI–NSAID products that may be developed and receive regulatory approval, may come from the oral NSAID market, specifically the traditional non-selective NSAIDs (such as naproxen and diclofenac), traditional NSAID/gastroprotective agent combination products or combination product packages (such as Arthrotec® and Prevacid® NapraPAC), combinations of NSAIDs and PPIs taken as separate pills and the only remaining COX-2 inhibitor, Celebrex®.  The Toprol-XL franchise competes against several generic offerings for metoprolol succinate.  A new generic version of metoprolol succinate was approved by the FDA in February 2018 and additional generic competitors may enter the market. Zontivity competes with certain products referred to as oral anti-platelets, which market is dominated by the generic offerings for clopidogrel bisulfate. There is also a competitive branded offering in this class: Brilinta®.

 

Based upon their drug product and pipeline portfolios and the overall competitiveness of our industry, we believe that we face, and will continue to face, intense competition from other companies for securing collaborations with pharmaceutical companies, establishing relationships with academic and research institutions, and acquiring licenses to proprietary technology. Our competitors, either alone or with collaborative parties, may also succeed with technologies or products that are more effective than any of our current or future technologies or products. Many of our actual or potential competitors, either alone or together with collaborative parties, have substantially greater financial resources, and almost all of our competitors have larger numbers of scientific and administrative personnel than we do. If we cannot successfully compete with new or existing products, our marketing and sales will suffer and we may not ever receive any revenues from sales of products or may not receive sufficient revenues to achieve profitability.

 

Contractual relationships with governmental customers may impose special burdens on us and provide special benefits to those customers, including the right to change or terminate the contract in response to budgetary constraints, policy changes or competition.

 

A portion of our revenues come from customers that are governmental agencies or vendors to such agencies. These contracts generally contain certain rights for the benefit of the government customer, including termination for convenience, the right to place contracts out for bid before the full contract term, as well as the right to make unilateral changes in contract requirements. For example, in connection with our acquisition of the U.S. rights to the Toprol-XL Franchise, we entered into a Novation Agreement with AstraZeneca and the Government pursuant to which all of the rights and responsibilities of AstraZeneca under the VA Contract between AstraZeneca and the Government were novated to a subsidiary of Aralez.  The VA Contract is terminable at the convenience of the Government at any time and

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the Government could therefore use such right to try to renegotiate pricing terms, which could adversely affect our gross margins and results of operations.

 

Government contracts and subcontracts may also be subject to some or all of the following:

 

·

termination when appropriated funding for the current fiscal year is exhausted or becomes unavailable;

 

·

“most-favored” pricing disclosure requirements that are designed to ensure that the government can negotiate and receive pricing akin to that offered commercially and requirements to submit proprietary cost or pricing data to ensure that government contract pricing is fair and reasonable;

 

·

commercial customer price tracking requirements that require contractors to monitor pricing offered to a specified class of customers and to extend price reductions offered to that class of customers to the government;

 

·

reporting and compliance requirements related to, among other things: equal employment opportunity, affirmative action for veterans and for workers with disabilities, and accessibility for the disabled;

 

·

broader audit rights than we would usually grant to non-governmental customers; and

 

·

specialized remedies for breach and default or failure to meet service level commitments, including setoff rights, retroactive price adjustments, and civil or criminal fraud penalties, as well as mandatory administrative dispute resolution procedures instead of state contract law remedies.

 

In addition, certain violations of federal law may subject government contractors to having their contracts terminated and, under certain circumstances, suspension and/or debarment from future government contracts.

 

If we lose our license from any licensors, we may be unable to continue a substantial part of our business.

 

We have licensed certain assets, including certain intellectual property, marketing authorizations and related data, and medical commercial and technical information, used in a substantial part of our business. Such license agreements may be terminated by the licensor if we are in breach of our obligations under, or fail to perform any terms of, the agreement and fail to cure that breach. If a license agreement is terminated, then we may lose our rights to utilize the intellectual property and other assets covered by such agreement to manufacture, market, promote, distribute and sell the licensed products, which may prevent us from continuing a substantial part of our business and may result in a material adverse effect on our financial condition, results of operations and any prospects for growth.

 

Developments following regulatory approval may adversely affect sales of the Company’s products.

 

Even after a product reaches market, certain developments following regulatory approval, including results in post-marketing requirements, Phase IV trials or other studies, may decrease demand for the Company’s products, including the following:

 

·

the re-review of products that are already marketed;

 

·

new scientific information and evolution of scientific theories;

 

·

the recall or loss of marketing approval of products that are already marketed;

 

·

changing government standards or public expectations regarding safety, efficacy or labeling changes; and

 

·

greater scrutiny in advertising and promotion.

 

Events giving rise to concerns among some prescribers and patients relating to the safety or efficacy of pharmaceutical products, whether or not scientifically justified, can lead to product recalls, withdrawals, or declining

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sales, as well as product liability, consumer fraud and/or other claims, including potential civil or criminal governmental actions. 

 

We depend on key personnel and may not be able to retain these employees or recruit additional qualified personnel, which would harm our business as well as our ability to identify, acquire, close or integrate acquisition targets successfully.

 

We are highly dependent on the efforts of our key management, especially Adrian Adams, our Chief Executive Officer, and Andrew I. Koven, our President and Chief Business Officer. If we should lose the services of Mr. Adams or Mr. Koven, or are unable to replace the services of our other key personnel who may leave the Company, or if we fail to recruit or retain other key personnel, we may be unable to achieve our business objectives. There is intense competition for qualified personnel. We may not be able to continue to attract and retain the qualified personnel necessary for developing our business. Furthermore, our future success may also depend in part on the continued service of our other key management personnel and our ability to recruit and retain additional personnel, as required by our business. Many of the other biotechnology and pharmaceutical companies with whom we compete for qualified personnel have greater financial and other resources, different risk profiles and longer histories in the industry than we do. They also may provide more diverse opportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we have to offer. If we are unable to continue to attract and retain high quality personnel, the rate and success at which we can develop our business will be limited.

 

Our business, financial condition and results of operations are subject to risks arising from the international scope of our operations.

 

Our international operations and any future international operations may expose us to risks that could negatively impact our future results. The additional risks that we may be exposed to in these cases include, but are not limited to:

 

·

tariffs and trade barriers;

 

·

currency fluctuations, which could decrease the Company’s revenues or increase its costs;

 

·

regulations related to customs and import/export matters;

 

·

tax issues, such as tax law changes and variations in tax laws;

 

·

limited access to qualified staff;

 

·

inadequate infrastructure;

 

·

cultural and language differences;

 

·

inadequate banking systems;

 

·

different and/or more stringent environmental laws and regulations;

 

·

restrictions on the repatriation of profits or payment of dividends;

 

·

crime, strikes, riots, civil disturbances, terrorist attacks or wars;

 

·

nationalization or expropriation of property;

 

·

law enforcement authorities and courts that are weak or inexperienced in commercial matters; and

 

·

deterioration of political relations among countries.

 

Any of these factors, or any other international factors, could have a material adverse impact on our business, financial condition and results of operations and could cause the market value of our common shares to decline. Similarly, adverse economic conditions impacting our customers in these countries or uncertainty about global economic conditions could

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cause purchases of our products to decline, which would adversely affect our revenues and operating results. Any failure to attain our projected revenues and operating results as a result of adverse economic or market conditions could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

 

Due to a portion of our business conducted in currency other than U.S. dollars, we have foreign currency risk. 

 

Our consolidated financial statements are presented in accordance with U.S. generally accepted accounting principles, and we report, and will continue to report, our results in U.S. dollars. Some of our transactions are conducted in currencies other than the U.S. dollar. Any change in the value of currencies in which we transact against the U.S. dollar during a given financial reporting period would result in a foreign currency loss or gain. The exchange rates between many of the currencies in which we transact against the U.S. dollar have fluctuated significantly in recent years and may fluctuate significantly in the future. Consequently, our reported earnings could fluctuate materially as a result of foreign exchange (translation) gains or losses and may not be comparable from period to period.

 

We face market risks attributable to fluctuations in foreign currency exchange rates and foreign currency exposure on the translation into U.S. dollars of the financial results of our operations in Canada. Exchange rate fluctuations could have an adverse effect on our results of operations. Both favorable and unfavorable foreign currency impacts to our foreign currency-denominated operating expenses are mitigated to a certain extent by the natural, opposite impact on our foreign currency-denominated revenue. In addition, the repurchase of principal under our U.S. dollar denominated debt may result in foreign exchange gains or losses for Canadian income tax purposes.

 

Risks related to Legislation and Regulations

 

As we pursue commercialization of our product portfolio and other opportunities for our future products, failure to comply with the laws governing the marketing and sale of such products may result in regulatory agencies taking action against us and/or our partners, which could significantly harm our business.

 

As we pursue commercialization of Zontivity, the Toprol-XL Franchise, Fibricor and its authorized generic, our Canadian product portfolio and other future products, we will be subject to extensive regulation by the FDA, Health Canada, EMA and the governmental authorities in other countries. In particular, there are many federal, state, provincial and local laws that we will need to comply with in connection with the marketing, promoting, distribution and sale of pharmaceutical products. If we fail to comply with U.S., Canadian and European regulatory requirements and those in other countries where our products are sold, we could lose our marketing approvals or be subject to civil and/or criminal penalties, injunctions, fines or other sanctions. In addition, incidents of adverse drug reactions, unintended side effects or misuse relating to our products could result in additional regulatory controls or restrictions, or even lead to withdrawal of a product from the market. The imposition of one or more of these penalties could adversely affect our revenues and our ability to conduct our business as planned. As a condition to granting marketing approval of a product, the FDA, Health Canada, EMA or other applicable regulatory authorities may require a company to conduct additional clinical trials, the results of which could result in the subsequent loss of marketing approval, changes in product labeling or new or increased concerns about side effects or efficacy of a product. Compliance with the extensive laws and regulations to which we are subject is complicated, time-consuming and expensive. We cannot assure you that we will be in compliance with all potentially applicable laws and regulations. Even minor, inadvertent irregularities can potentially give rise to claims that the law has been violated.

 

We are subject to various laws and regulations, including “fraud and abuse” laws, anti-bribery laws and privacy and security regulations, and a failure to comply with such laws and regulations or prevail in any litigation related to noncompliance could have a material adverse impact on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

 

Pharmaceutical and biotechnology companies have faced lawsuits and investigations pertaining to violations of healthcare “fraud and abuse” laws, such as the federal False Claims Act, the federal Anti-Kickback Statute, the United States Foreign Corrupt Practices Act (the “FCPA”) and other federal, state and provincial laws and regulations. We also face increasingly strict data privacy and security laws in the United States, Canada, the EU and other countries, the violation of which could result in fines and other sanctions. The United States Department of Health and Human Services Office of Inspector General recommends, and increasingly states, that pharmaceutical companies have

40


 

comprehensive compliance programs and disclose certain payments made to healthcare providers or funds spent on marketing and promotion of drug products. While we have developed a corporate compliance program, we cannot assure you that we or our employees or agents are or will be in compliance with all applicable federal, state, provincial or foreign regulations and laws. If we are in violation of any of these requirements or any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines, exclusion from federal healthcare programs or other sanctions.

 

The FCPA, the Canadian Corruption of Foreign Public Officials Act (the “CFPOA”) and similar worldwide anti-bribery laws generally prohibit companies and their intermediaries from making improper payments to officials for the purpose of obtaining or retaining business. Although we require our employees to consult with our legal department prior to making any payment or gift thought to be exempt under applicable law, there is no assurance that such policies or procedures will work effectively all of the time or protect us against liability under the FCPA and/or the CFPOA for actions taken by our employees and other intermediaries with respect to our business or any businesses that we may acquire. We may operate in parts of the world that have experienced governmental corruption to some degree and, in certain circumstances, strict compliance with anti-bribery laws may conflict with local customs and practices or may require us to interact with doctors and hospitals, some of which may be state controlled, in a manner that is different from the United States and Canada. We cannot assure you that our internal control policies and procedures will protect us from reckless or criminal acts committed by our employees or agents. Violations of these laws, or allegations of such violations, could disrupt our business and result in criminal or civil penalties or remedial measures, any of which could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

 

We are also subject to various privacy and security regulations, including, but not limited to, the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (as amended, “HIPAA”). HIPAA mandates, among other things, the adoption of uniform standards for the electronic exchange of information in common healthcare transactions (e.g., healthcare claims information and plan eligibility, referral certification and authorization, claims status, plan enrollment, coordination of benefits and related information), as well as standards relating to the privacy and security of individually identifiable health information, which require the adoption of administrative, physical and technical safeguards to protect such information. In addition, many states have enacted comparable laws addressing the privacy and security of health information, some of which are more stringent than HIPAA. Failure to comply with these laws can result in the imposition of significant civil and criminal penalties.

 

Numerous other countries have, or are developing, laws governing the collection, use and transmission of personal information as well. The EU and other jurisdictions have adopted data protection laws and regulations, which impose significant compliance obligations. For example, the EU Data Protection Directive, as implemented into national laws by the EU member states, imposes strict obligations and restrictions on the ability to collect, analyze, and transfer personal data, including health data from clinical trials and adverse event reporting. Data protection authorities from different EU member states have interpreted the privacy laws differently, which adds to the complexity of processing personal data in the EU, and guidance on implementation and compliance practices are often updated or otherwise revised. Any failure to comply with the rules arising from the EU Data Protection Directive and related national laws of EU member states could lead to supervisory authority enforcement actions, reputational damage and significant penalties against us, adversely impacting our operating results.

 

In December 2015, a proposal for an EU Data Protection Regulation, intended to replace the current EU Data Protection Directive, was agreed between the European Parliament, the Council of the European Union and the European Commission. The EU General Data Protection Regulation (“GDPR”), which is enforceable from May 25, 2018 will expand our data protection obligations, including by imposing more stringent conditions for consent from data subjects, strengthening the rights of individuals, including the right to have personal data deleted upon request, continuing to restrict the trans-border flow of such data, requiring mandatory data breach reporting and notification, increasing penalties for non-compliance and increasing the enforcement powers of the national data protection authorities. The GDPR will increase our responsibility and liability in relation to personal data that we process and we may be required to put in place additional mechanisms to ensure compliance with the GDPR. The GDPR harmonises EU data protection laws and is intended to make it easier for multinational companies operating across the EU to comply with their data protection obligations. However, it does permit EU member states some flexibility to legislate in a number of areas, which means that inconsistencies may still arise.

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The costs of compliance with these laws and the potential liability associated with the failure to comply with these laws could adversely affect our financial condition, results of operations and cash flows.

 

Legislative or regulatory reform of the healthcare system may affect our ability to sell our products profitably and could adversely affect our business.

 

In the United States and certain state and foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the healthcare system in ways that could impact our ability to sell our products profitably. The ACA may affect the operational results of companies in the pharmaceutical industry, including the Company and other healthcare-related industries, by imposing on them additional costs. Effective January 1, 2010, the ACA increased the minimum Medicaid drug rebates for pharmaceutical companies, expanded the 340B drug discount program, and made changes to affect the Medicare Part D coverage gap, or “donut hole.” The law also revised the definition of “average manufacturer price” for reporting purposes. Beginning in 2011, the law imposed a significant annual fee on companies that manufacture or import branded (including authorized generics) prescription drug products.

 

The ACA also added substantial new provisions affecting compliance, some of which required the entire industry to modify business practices with healthcare practitioners. Pharmaceutical manufacturers are required to comply with the federal Physician Payments Sunshine Act, which was enacted as part of the ACA and requires pharmaceutical companies to monitor and report certain financial arrangements with physicians and teaching hospitals, including any “transfer of value” made or distributed to such entities, as well as any investment interests held by physicians and their immediate family members.  The information reported each year is made publicly available on a searchable website.

 

We are unable to predict the future course of federal or state healthcare legislation. A variety of federal and state agencies are in the process of implementing the ACA, including through the issuance of rules, regulations or guidance that materially affect our business. The risk of our being found in violation of these rules and regulations is increased by the fact that many of them have not been fully interpreted by applicable regulatory authorities or the courts, and their provisions are open to a variety of interpretations. In addition, there is substantial uncertainty regarding the future of the ACA as there is continued interest to repeal and/or replace all or certain aspects of such laws. The outcome of such efforts could have a substantial impact on our business. The ACA, changes thereto or replacements thereof and further changes to healthcare laws or regulatory framework that reduce our revenues or increase our compliance or other costs could also have a material adverse effect on our business, financial condition and results of operations and cash flows, and could cause the market value of our common shares to decline.

 

In addition, pharmaceutical product pricing is subject to enhanced government and public scrutiny and calls for reform. Efforts by government officials or legislators to implement measures to regulate prices or payment for pharmaceutical products could adversely affect our business if implemented.

 

In Canada, patented drug products are subjected to regulation by the PMPRB pursuant to the Patent Act (Canada) and the Patented Medicines Regulations. The PMPRB does not approve prices for drug products in advance of their introduction to the market. The PMPRB provides guidelines from which companies like us set their prices at the time they launch their products. All patented pharmaceutical products introduced in Canada are subject to the post-approval, post-launch scrutiny of the PMPRB. Since the PMPRB does not pre-approve prices for a patented drug product in Canada, there may be risk involved in the determination of an allowable price selected for a patented drug product at the time of introduction to the market by the company launching such products in Canada. If the PMPRB does not agree with the pricing assumptions chosen by such company introducing a new drug product, the price chosen could be challenged by the PMPRB pursuant to the PMPRB initiating an investigation and, if it is determined, usually pursuant to an oral tribunal hearing, that the price charged is excessive, the price of the product may be reduced and a fine may be levied against the company for any amount deemed to be in excess of the allowable price determined. Drug products that have no valid patents are not subject to the PMPRB’s jurisdiction.

 

Our status as a foreign corporation for U.S. federal tax purposes could be affected by IRS action or a change in U.S. tax law.

 

Although the Company is incorporated in British Columbia, Canada, the Internal Revenue Service (the “IRS”) may assert that we should be treated as a U.S. corporation (and, therefore, a U.S. tax resident) for U.S. federal income tax purposes pursuant to Section 7874 of the Internal Revenue Code of 1986, as amended (the “Code”). A corporation is

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generally considered a tax resident in the jurisdiction of its organization or incorporation for U.S. federal income tax purposes. As a result of the Company being an entity incorporated in the Province of British Columbia, it would generally be classified as a foreign corporation (and, therefore, a non-U.S. tax resident) under these rules. Section 7874 of the Code provides an exception pursuant to which a foreign incorporated entity may, in certain circumstances, be treated as a U.S. corporation for U.S. federal income tax purposes.

 

Under Section 7874 of the Code, the Company may be treated as a U.S. corporation for U.S. federal income tax purposes if former Pozen shareholders hold 80% or more of the vote or value of the Company’s shares by reason of holding stock in Pozen immediately after Merger and the Company’s expanded affiliated group after the Merger does not have substantial business activities in Canada relative to its worldwide activities. As a result of the fact that the former shareholders of Pozen owned (within the meaning of Section 7874 of the Code) less than 80% (by both vote and value) of the combined entity’s stock immediately after the Merger, we believe we qualify as a foreign corporation for U.S. federal income tax purposes following the Merger. However, there can be no assurance that there will not exist in the future a subsequent change in the facts or in law, which might cause us to be treated as a domestic corporation for U.S. federal income tax purposes, including with retroactive effect.

 

Further, there can be no assurance that the IRS will agree with the position that the ownership test was satisfied. There is limited guidance regarding the application of Section 7874 of the Code, including with respect to the provisions regarding the application of the ownership test. If we were unable to be treated as a foreign corporation for U.S. federal income tax purposes, the benefits associated with enhanced global cash management, including increased liquidity resulting from access to cash generated by our non-U.S. subsidiaries, would be jeopardized.

 

Our tax position may be adversely affected by changes in tax law relating to multinational corporations, or increased scrutiny by tax authorities.

 

Under current law, we expect to be treated as a foreign corporation for U.S. federal tax purposes. However, changes to the rules in Section 7874 of the Code or the U.S. Treasury regulations promulgated thereunder could adversely affect our status as a foreign corporation for U.S. federal tax purposes, and any such changes could have prospective or retroactive application. In addition, recent legislative proposals have aimed to expand the scope of U.S. corporate tax residence, and such legislation, if passed, could have an adverse effect on us.

 

Moreover, the United States Congress, the Organization for Economic Co-operation and Development and other government agencies in Canada and other jurisdictions where we and our affiliates do business have had an extended focus on issues related to the taxation of multinational corporations. One example is in the area of “base erosion and profit shifting,” where payments are made between affiliates from a jurisdiction with high tax rates to a jurisdiction with lower tax rates. As a result, the tax laws in the United States, Canada and other countries in which we and our affiliates do business could change on a prospective or retroactive basis, and any such changes could adversely affect us.

 

For example, in April 2016, the U.S. Treasury and IRS issued temporary regulations that expand the scope of transactions that are subject to the rules designed to eliminate the U.S. tax benefits of inversions, which regulations could limit our ability to engage in certain stock transactions in the future. Additionally, in October 2016 the U.S. Treasury and IRS issued final and temporary regulations that address whether an interest in a related corporation is debt or equity, which regulations would impact the treatment of future inter-company debt and limit the ability to deduct interest thereon. In October 2017, the U.S. Treasury indicated that certain portions of these regulations may be revoked.

 

Changes in tax laws and unanticipated tax obligations could adversely affect our effective income tax rate, other tax obligations and profitability.

 

We are subject to income and other taxes in Canada, the United States, and certain foreign jurisdictions. Our effective income tax rate and other tax obligations in the future could be adversely affected by a number of factors including changes in the mix of earnings in countries with differing statutory tax rates, changes in the valuation of deferred tax assets and liabilities, disagreements with taxing authorities with respect to the interpretation of tax laws and regulations and changes in tax laws. We regularly assess all of these matters to determine the adequacy of our tax provision which is subject to discretion. If our assessments are incorrect, it could have an adverse effect on our business and financial condition.

 

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On December 22, 2017, the U.S. government enacted comprehensive tax legislation, referred to as the Tax Cuts and Jobs Act (the “Tax Act”).   The Tax Act significantly revises U.S. tax law by, among other provisions, lowering the U.S. federal statutory corporate income tax rate from 35% to 21%, imposing a mandatory one-time transition tax on previously deferred foreign earnings, and eliminating or reducing certain income tax deductions.

 

ASC 740, Income Taxes requires the effects of changes in tax laws to be recognized in the period in which the legislation is enacted. However, due to the complexity and significance of the Tax Act’s provisions, the Securities and Exchange Commission (the “SEC”) staff issued Staff Accounting Bulletin No. 118 (“SAB 118”), which allows companies to record the tax effects of the Tax Act on a provisional basis based on a reasonable estimate, and then, if necessary, subsequently adjust such amounts during a limited measurement period as more information becomes available. The measurement period ends when a company has obtained, prepared, and analyzed the information necessary to finalize its accounting, but cannot extend beyond one year from enactment.

 

The Tax Act did not have a material impact on our financial statements since our deferred temporary differences are fully offset by a valuation allowance and we do not have any significant off shore earnings from which to record the mandatory transition tax.   However, given the significant complexity of the Tax Act, anticipated guidance from the U.S. Treasury about implementing the Tax Act, and the potential for additional guidance from the SEC or the FASB related to the Tax Act, these estimates may be adjusted during the measurement period.  The provisional amounts disclosed in our footnotes were based on our present interpretations of the Tax Act and current available information, including assumptions and expectations about future events, such as its projected financial performance, and are subject to further refinement as additional information becomes available (including the Company’s actual full fiscal 2018 results of operations, as well as potential new or interpretative guidance issued by the FASB or the Internal Revenue Service and other tax agencies) and further analyses are completed.  We continue to analyze the changes in certain income tax deductions, assess calculations of earnings and profits in certain foreign subsidiaries, including if those earnings are held in cash or other assets and gather additional data to compute the full impacts on our deferred and current tax assets and liabilities. Further, we are also evaluating the potential overall impact of the Tax Act on our financial condition, operations and cash flows.

 

There can be no assurance that income and other tax laws and administrative policies with respect to the income and other tax consequences generally applicable to us, to our subsidiaries, or to a U.S. or Canadian holder of common shares will not be changed in a manner which adversely affects holders of our common shares.

 

If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program, Medicare, PMPRB obligations, governmental funded drug formularies or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and/or fines which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

 

Pricing and rebate calculations vary among products and programs. The calculations are complex and are often subject to interpretation by us, governmental or regulatory agencies and the courts. We cannot assure you that our submissions will not be found by CMS to be incomplete or incorrect. Governmental agencies may also make changes in program interpretations, requirements or conditions of participation, some of which may have implications for amounts previously estimated or paid. The Medicaid rebate amount is computed each quarter based on our submission to CMS of our current average manufacturer price and best price for the quarter. If we become aware that our reporting for a prior quarter was incorrect, or has changed as a result of recalculation of the pricing data, we are obligated to resubmit the corrected data for a period not to exceed twelve quarters from the quarter in which the data originally were due, and CMS may request or require restatements for earlier periods as well. Such restatements and recalculations increase our costs for complying with the laws and regulations governing the Medicaid Drug Rebate Program. Any corrections to our rebate calculations could result in an overage or underage in our rebate liability for past quarters, depending on the nature of the correction. Price recalculations also may affect the ceiling price at which we are required to offer our products to certain covered entities, such as safety-net providers, under the 340B drug discount program.

 

We are liable for errors associated with our submission of pricing data. In addition to retroactive rebates and the potential for 340B program refunds, if we are found to have knowingly submitted false average manufacturer price, average sales price (“ASP”), or best price information to the government or made a misrepresentation in the reporting of our ASP, we may be liable for civil monetary penalties. Our failure to submit monthly/quarterly average manufacturer price, ASP, and best price data on a timely basis could result in a civil monetary penalty. Such failure also could be grounds for CMS to terminate our Medicaid drug rebate agreement, pursuant to which we participate in the Medicaid

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program. In the event that CMS terminates our rebate agreement, federal payments may not be available under Medicaid or Medicare Part B for our covered outpatient drugs.

 

Federal law requires that a company must participate in the Department of Veterans Affairs Federal Supply Schedule (“FSS”) pricing program, established by Section 603 of the Veterans Health Care Act of 1992, to be eligible to have its products paid for with federal funds. If we overcharge the government in connection with our FSS contract, whether due to a misstated federal ceiling price or otherwise, we are required to refund the difference to the government. Failure to make necessary disclosures and/or to identify contract overcharges can result in allegations against us under the False Claims Act and other laws and regulations. Unexpected refunds to the government, and responding to a government investigation or enforcement action, would be expensive and time-consuming, and could have a material adverse effect on our business, financial condition, and results of operations.

 

Our business involves the use of hazardous materials, and we and our third-party manufacturers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.

 

Our third-party manufacturers’ activities involve the controlled storage, use and disposal of hazardous materials owned by us, including the components of our approved products and product candidates and other hazardous compounds. We and our manufacturers are subject to federal, state, provincial and local as well as foreign laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. Although we believe that the safety procedures utilized by our third-party manufacturers for handling and disposing of these materials comply with the standards prescribed by these laws and regulations, we cannot eliminate the risk of accidental contamination or injury from these materials. In the event of an accident, federal, state, provincial or foreign authorities may curtail the use of these materials and interrupt our business operations. We do not currently maintain hazardous materials insurance coverage. If we are subject to any liability as a result of our third-party manufacturers’ activities involving hazardous materials, our business and financial condition may be adversely affected.

 

Risks Related to Our Intellectual Property and Product Liability

 

We may become involved in infringement actions which are uncertain, costly and time-consuming and could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

 

The pharmaceutical industry historically has generated substantial litigation concerning the manufacture, use and sale of products, and we expect this litigation activity to continue. The intellectual property rights of pharmaceutical companies, including us, are generally uncertain and involve complex legal, scientific and factual questions. In order to protect or enforce patent rights, we may initiate litigation against third parties. If we are not successful in defending an attack on our patents and maintaining exclusive rights to market one or more of our products still under patent protection, we could lose a significant portion of sales in a very short period. We may also become subject to infringement claims by third parties and may have to defend against charges that we infringed patents or the proprietary rights of third parties. If we infringe the intellectual property rights of others, we could lose our right to develop or sell products, including our generic products, or could be required to pay monetary damages or royalties to license proprietary rights from third parties. The outcomes of infringement actions are uncertain and infringement actions are costly and divert technical and management personnel from their normal responsibilities.

 

Third parties seeking to market generic versions of branded pharmaceutical products in the United States often file ANDAs with the FDA (with a similar process in Canada and other foreign countries) containing a certification stating that the ANDA applicant believes that the patents protecting the branded pharmaceutical product are invalid, unenforceable and/or not infringed. Such certifications are commonly referred to as Paragraph IV certifications. We and Horizon are engaged in Paragraph IV litigations with several generic pharmaceutical companies with respect to our Vimovo patents. If we are unsuccessful in any of these proceedings, or once our or our licensors’ applicable patents expire, and the FDA or Health Canada approve a generic version of one of our marketed products, such an outcome would have a material adverse effect on sales of such product, our business and our results of operations.

 

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If we are unable to obtain or protect intellectual property rights related to our products and product candidates, we may not be able to compete effectively in our market.

 

The pharmaceutical industry places considerable importance on obtaining patent and trade secret protection for new technologies, products and processes. Our success will depend, in part, on our ability, and the ability of our licensors, to obtain and to keep protection for our products and technologies under the patent laws of the United States and other countries, so that we can stop others from using our inventions. Our success also will depend on our ability to prevent others from using our trade secrets. In addition, we must operate in a way that does not infringe, or violate, the patent, trade secret and other intellectual property rights of other parties.

 

We cannot know how much protection, if any, our patents will provide or whether our patent applications will issue as patents. The breadth of claims that will be allowed in patent applications cannot be predicted and neither the validity nor enforceability of claims in issued patents can be assured. If, for any reason, we are unable to obtain and enforce valid claims covering our products and technology, we may be unable to prevent competitors from using the same or similar technology or to prevent competitors from marketing identical products. For example, if we and our partner Horizon are unsuccessful in protecting our patents in the litigation against several generic pharmaceutical companies who have filed ANDAs for Vimovo, such companies could market a generic version of the product prior to the expiration of our patents.

 

Furthermore, even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property or prevent others from designing around our claims. If the patent applications we hold fail to issue or if their breadth or strength of protection is threatened, it could dissuade companies from collaborating with us to develop them and threaten our ability to commercialize our products. We cannot offer any assurances about which, if any, patents will issue or whether any issued patents will be found invalid or unenforceable or will go unthreatened by third parties. Since patent applications in the United States and most other countries are confidential for a period of time after filing, and some remain so until issued, we cannot be certain that we were the first to file any patent application related to our products or any other product candidates. Furthermore, if third parties have filed such patent applications, an interference proceeding in the United States may be able to be provoked by a third-party or instituted by us to determine who was the first to invent any of the subject matter covered by the patent claims of our applications or, as in many jurisdictions, such as in Canada, the earlier filed third-party application may be cited against our patent application by a patent office in rejecting our application on the basis that the invention lacks novelty.

 

Our ability to obtain patents is highly uncertain because, to date, some legal principles remain unresolved, there has not been a consistent policy regarding the breadth or interpretation of claims allowed in patents in the United States and other jurisdictions, and the specific content of patents and patent applications that are necessary to support and interpret patent claims is highly uncertain due to the complex nature of the relevant legal, scientific and factual issues. Changes in either patent laws or interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property or narrow the scope of our patent protection. For example, in 2011, the Leahy-Smith America Invents Act (the “Leahy-Smith Act”) was enacted, and it included a number of significant changes to patent law in the United States. These include provisions that affect the way patent applications will be prosecuted and may also affect patent litigation. The United States Patent and Trademark Office has developed new and untested regulations and procedures to govern the full implementation of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, and in particular, the first to file provisions, only became effective in March 2013. The Leahy-Smith Act has also introduced procedures making it easier for third parties to challenge issued patents, as well as to intervene in the prosecution of patent applications. For example, third parties have filed petitions seeking Inter Partes Review (“IPR”) of some of our Vimovo patents, one of which has been instituted for review by the Patent Trial and Appeal Board (“PTAB”) and another of which has not yet been acted upon by the PTAB.  Finally, the Leahy-Smith Act contains statutory provisions that require the United States Patent and Trademark Office to issue new regulations for their implementation and it may take the courts years to interpret the provisions of the new statute. Accordingly, it is too early to tell what, if any, impact the Leahy-Smith Act will have on the operation of our business and the protection and enforcement of our intellectual property. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. In addition, the Patient Protection and Affordable Care Act allows applicants seeking approval of biosimilar or interchangeable versions of biological products to initiate a process for challenging some or all of the patents covering the innovator biological product used as the reference product. This process is complicated and could result in the limitation or loss of certain patent rights. An inability to obtain, enforce and defend patents covering our proprietary technologies would materially and adversely affect our business prospects and financial condition.

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Further, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States and Canada. As a result, we may encounter significant problems in protecting and defending our intellectual property in the United States, Canada and other countries. For example, if the issuance to us, in a given country, of a patent covering an invention is not followed by the issuance, in other countries, of patents covering the same invention, or if any judicial interpretation of the validity, enforceability, or scope of the claims in, or the written description or enablement in, a patent issued in one country is not similar to the interpretation given to the corresponding patent issued in another country, our ability to protect our intellectual property in those countries may be limited. For example, since patent protection is territorial, the teachings of a U.S. patent will generally only be protected in the United States. If we do not have a corresponding patent in another jurisdiction, the teachings of the U.S. patent may be in the public domain in such jurisdiction and free for a third-party to practice. Changes in either patent laws or in interpretations of patent laws in the United States, Canada and other countries may materially diminish the value of our intellectual property or narrow the scope of our patent protection. If we are unable to prevent material disclosure of the non-patented intellectual property related to our technologies to third parties, and there is no guarantee that we will have enforceable trade secret protection with respect thereto, we may not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, results of operations and financial condition.

 

In addition to the protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable, processes for which patents are difficult to enforce and any other elements of our drug discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. However, trade secrets are difficult to protect, and we cannot be certain that others will not develop the same or similar technologies on their own. We have taken steps, including entering into confidentiality agreements with our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors, to protect our trade secrets and unpatented know-how. These agreements generally require that the other party keep confidential and not disclose to third parties all confidential information developed by the party or made known to the party by the Company during the course of the party’s relationship with the Company. We also typically obtain agreements from these parties, which provide that inventions conceived by the party in the course of rendering services to the Company will be our exclusive property. However, these agreements may not be honored and may not effectively assign intellectual property rights to the Company. Enforcing a claim that a party illegally obtained and is using our trade secrets or know-how is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, courts outside Canada and the United States may be less willing to protect trade secrets or know-how. The failure to obtain or maintain trade secret protection could adversely affect our competitive position.

 

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products.

 

We face an inherent business risk of exposure to significant product liability and other claims in the event that the use of our products caused, or is alleged to have caused, adverse effects. For example, we may be sued if any of our products or product candidates allegedly causes injury or is found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates. The withdrawal of a product following complaints and/or incurring significant costs, including the requirement to pay substantial damages in personal injury cases or product liability cases, could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

 

Our product liability insurance coverage may not be sufficient to cover our claims and we may not be able to obtain sufficient coverage at a reasonable cost in the future. We will explore, on an on-going basis, expanding our insurance coverage related to the sale of our products and future marketed products when we obtain marketing approval for such products and commercial sales of such products begin. However, we may not be able to obtain commercially reasonable product liability insurance for any products approved for marketing. If a plaintiff brings a successful product liability claim against us in excess of our insurance coverage, if any, we may incur substantial liabilities and our business may be harmed or fail.

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If our products or technologies are stolen, misappropriated or reverse engineered, others could use our products or licensed products to produce competing products or technologies.

 

Third parties, including our partners, contract manufacturers, contractors and others involved in our business often have access to our products, licensed products, and technologies. If our products, licensed products or technologies were stolen, misappropriated or reverse engineered, they could be used by other parties that may be able to reproduce our products, licensed products, or technologies for their own commercial gain. If this were to occur, it would be difficult for us to challenge this type of use, especially in countries with limited intellectual property protection.

 

Risks Related to Ownership of Our Common Shares

 

The price of our common shares could be volatile, which may result in significant losses to our shareholders.

 

The trading price of our common shares could be highly volatile and subject to wide fluctuations in response to various factors, some of which are beyond our control, including limited trading volume. In addition to the factors discussed in the “Risk Factors” of this Annual Report on Form 10-K, these factors include:

 

·

fluctuations in our operating results and revenues generated by our marketed products;

 

·

announcements of technological innovations, acquisitions or licensing of therapeutic products or product candidates by us or our competitors;

 

·

prolonged stock shortages from third-party manufacturers;

 

·

published reports by securities analysts;

 

·

positive or negative progress with our clinical trials, if any, or with regulatory approvals of our product candidates;

 

·

commercial success of Vimovo, Zontivity, Toprol-XL, Fibricor and our other products and product candidates once approved;

 

·

generic introductions or additional generic competition with respect to marketed products, including additional generic competition for Toprol-XL and its authorized generic;

 

·

governmental regulation, including reimbursement policies;

 

·

developments in patent or other proprietary rights;

 

·

developments in our relationships with collaborative partners or our inability to obtain consents or achieve minimum licensing terms;

 

·

announcements by our collaborative partners regarding our products or product candidates;

 

·

developments in new or pending litigation;

 

·

public concern as to the safety and efficacy of our products;

 

·

our ability to acquire or license new products or companies and the perception of the value of such transactions, and our ability to integrate and grow such products or companies;

 

·

the sale or attempted sale of a large amount of our common shares into the market; and

 

·

general market conditions.

 

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The common shares are listed on the NASDAQ Global Market and the Toronto Stock Exchange. Volatility in the market prices of our common shares may increase as a result of our common shares being listed on both the NASDAQ Global Market and the Toronto Stock Exchange because trading is split between the two markets, resulting in less liquidity on both exchanges. In addition, different liquidity levels, volume of trading, currencies and market conditions on the two exchanges may result in different prevailing trading prices.

 

In addition, the stock market in general, and the NASDAQ Global Market, the Toronto Stock Exchange and the stocks of biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may adversely affect the market price of our common shares, regardless of our actual operating performance.

 

Sales of substantial amounts of shares of our common shares in the public market could cause our share price to decline.

 

If our existing shareholders sell, or indicate an intention to sell, substantial amounts of our common shares in the public market, the trading price of our common shares could decline. Certain shareholders hold significant positions in our common shares. Any sales of substantial amounts of our common shares in the public market, including sales or distributions of shares by our large investors, or the perception that such sales or distributions might occur, could harm the market price of our common shares and could impair our ability to raise capital through the sale of additional equity securities. Further, shareholder ownership will be diluted if we raise additional capital by issuing equity securities. In addition, our common shares that are either subject to outstanding options or reserved for future issuance under our employee benefit plans are or may become eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules and Rule 144 and Rule 701 under the Securities Act. If these additional common shares are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common shares could decline.

 

Anti-takeover provisions in our Articles and certain provisions under the BCBCA could prevent or delay transactions that our shareholders may favor and may prevent shareholders from changing the direction of our business or management.

 

Provisions of our Articles and certain provisions under the BCBCA may discourage, delay or prevent a merger or acquisition that our shareholders may consider favorable, including transactions in which shareholders might otherwise receive a premium for their shares, and may also frustrate or prevent any attempt by shareholders to change the direction or management of the Company. For example, these provisions:

 

·

authorize the issuance of “blank check” preferred shares without any need for action by shareholders;

 

·

require a 75% majority of shareholder votes cast in favor of a resolution to remove a director;

 

·

require a 66 2/3% majority of shareholder votes cast in favor of a resolution to effect various amendments to our Articles;

 

·

require that in the case of shareholder action by written consent, (i) a matter that would normally require an ordinary resolution shall require written consent by shareholders representing at least 66 2/3% of the votes entitled to be cast in favor of such resolution, and (ii) in the case of any other resolution of the shareholders, the written consent of shareholders representing 100% of the votes entitled to be cast in favor of such resolution;

 

·

establish advance notice requirements for nominations for election to the Board of Directors; and

 

·

require shareholder proposals for matters to be acted upon by shareholders at shareholder meetings to be submitted pursuant to, and in accordance with, the applicable provisions of the BCBCA for inclusion in the Company’s proxy materials by a date that is not later than three months prior to the anniversary date of the prior year’s shareholder meeting.

 

These provisions, among others, whether alone or together, could delay or impede hostile takeovers and changes in control or changes to the composition of our Board of Directors or management. Any provision of our

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constating documents that has the effect of delaying or deterring a change in control could limit the opportunity for our shareholders to receive a premium for their common shares and could also affect the price that some investors are willing to pay for our common shares.

 

Provisions of Canadian law may delay, prevent or make undesirable an acquisition of all or a significant portion of our common shares or assets.

 

The Investment Canada Act (Canada) (the “Investment Canada Act”) subjects an acquisition of control of us by a non-Canadian to government review if our enterprise value as calculated pursuant to the legislation exceeds a threshold amount. A reviewable acquisition may not proceed unless the relevant Minister is satisfied that the investment is likely to be of net benefit to Canada. This could prevent or delay a change of control and may eliminate or limit strategic opportunities for shareholders to sell their common shares.

 

The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation and these differences may make our common shares less attractive to investors.

 

The Company is incorporated under the laws of the Province of British Columbia, Canada, and therefore certain of the rights of holders of its common shares are governed by Canadian law, including the provisions of the BCBCA, and by our Notice of Articles and Articles. These rights differ in certain respects from the rights of shareholders in typical U.S. corporations and these differences may make our common shares less attractive to investors.

 

An investor may be unable to bring actions or enforce judgments against us and certain of our directors.

 

The Company is incorporated under the laws of the Province of British Columbia. Some of our directors reside principally outside of the United States and a substantial portion of our assets and a substantial portion of the assets of these persons are located outside the United States. Consequently, it may not be possible for an investor to effect service of process within the United States on us or those persons. Furthermore, it may not be possible for an investor to enforce judgments obtained in United States courts based upon the civil liability provisions of United States federal securities laws or other laws of the United States against us or those persons.

 

We do not expect to pay dividends for the foreseeable future, and our shareholders must rely on increases in the trading price of our common shares for returns on their investment.

 

Except for the $1.75 per share special cash distribution by Pozen on December 30, 2013 (representing a surplus of corporate cash and accounted for as a return of capital to shareholders), we have never paid cash dividends on our common shares and do not expect to pay dividends in the immediate future. We anticipate that the Company will retain all earnings, if any, to support our operations. Any future determination to pay dividends on our common shares will be at the sole discretion of the Board of Directors and will depend on, among other things, the Company’s results of operations, current and anticipated cash requirements and surplus, financial condition, contractual restrictions and financing agreement covenants, solvency tests imposed by corporate law and other factors that the Board of Directors may deem relevant. Holders of our common shares must rely on increases in the trading price of our shares for returns on their investment in the foreseeable future. In addition, the Facility Agreement prohibits the Company from making any cash dividend or distributing any of its assets, including its intangibles, to any of its shareholders in such capacity or its affiliates, subject to certain exceptions. The Facility Agreement also includes restrictions on the Company from incurring liens and undertaking indebtedness, subject to certain exceptions, which limitations may further impact the ability of the Company to pay any future dividends. See “Covenants and financial performance thresholds imposed by the Facility Agreement restrict our business and operations in many ways and if we do not effectively manage our covenants and financial performance thresholds, our financial conditions and results of operations could be adversely affected” above.

 

We have incurred and will continue to incur significant increased costs as a result of operating as a public company and our management will be required to devote substantial time to compliance initiatives.

 

As a public company, we have incurred and will continue to incur significant legal, accounting and other expenses that we would not incur if we were a private company. In particular, the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), as well as rules subsequently implemented by the SEC, applicable securities laws in Canada, the NASDAQ Global Market and the Toronto Stock Exchange, impose significant requirements on public companies, including requiring establishment and maintenance of effective disclosure and financial controls and changes in

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corporate governance practices. These rules and regulations have substantially increased our legal and financial compliance costs and have made some activities more time-consuming and costly. Further, these rules and regulations may lack specificity and are subject to varying interpretations. Their application in practice may evolve over time, as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs of compliance as a result of ongoing revisions to such corporate governance standards.

 

In particular, our efforts to comply with Section 404 of the Sarbanes-Oxley Act, National Instrument 52-109 - Certification of Disclosures in Issuers’ Annual and Interim Filings and the related regulations regarding our required assessment of our internal controls over financial reporting and our external auditors’ audit of that assessment requires the commitment of significant financial and managerial resources. We consistently assess the adequacy of our internal controls over financial reporting, remediate any control deficiencies that may be identified, and validate through testing that our controls are functioning as documented. While we do not anticipate any material weaknesses, the inability of management to assess our internal controls over financial reporting as effective could result in adverse consequences to us, including, but not limited to, a loss of investor confidence in the reliability of our financial statements, which could cause the market price of our stock to decline. The existence of this or one or more other material weaknesses or significant deficiencies in our internal control over financial reporting could result in errors in our financial statements, and substantial costs and resources may be required to rectify any internal control deficiencies. Although we continually review and evaluate internal control systems to allow management to report on the sufficiency of our internal controls, we cannot assure you that we will not discover weaknesses in our internal control over financial reporting. Any such weakness or failure to remediate any existing material weakness could materially adversely affect our ability to comply with applicable financial reporting requirements and the requirements of our various agreements.

 

We are committed to maintaining high standards of corporate governance and public disclosure, and our efforts to comply with evolving laws, regulations and standards in this regard have resulted in, and are likely to continue to result in, increased general and administrative expenses and a diversion of management time and attention from revenue-generating activities to compliance activities. In addition, the laws, regulations and standards regarding corporate governance may make it more difficult, or increasingly more expensive, for us to obtain director and officer liability insurance. Further, members of the Board of Directors and executive officers could face an increased risk of personal liability in connection with their performance of duties. As a result, we may face difficulties attracting and retaining qualified board members and executive officers, which could harm our business. If we fail to comply with new or changed laws, regulations or standards of corporate governance, our business and reputation may be harmed.

 

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the price and trading volume of our common shares could decline.

 

The trading market for our common shares will depend in part on the research and reports that securities or industry analysts publish about us or our business. There is no guarantee that securities analysts will cover our securities, and the lack of research coverage may adversely affect our share price. If one or more of the securities analysts publish inaccurate or unfavorable research about our business, our share price would likely decline. If one or more of these securities analysts cease coverage of the Company or fail to publish reports on us regularly, demand for our common shares could decrease, which might cause our share price and trading volume to decline.

 

 

ITEM 1B. Unresolved Staff Comments

 

None.

 

ITEM 2. Properties

 

The properties described below are used by the Company for general corporate purposes.

 

In September 2016, Aralez Ireland entered into a lease agreement for an approximately 5,715 square foot office space located in Dublin, Ireland. Aralez Ireland has agreed to assign this lease and has entered into a new lease agreement for a smaller office space (approximately 3,000 square feet) in Dublin, Ireland, which upon relocation (expected in March 2018), will serve as the Irish headquarters for Aralez. 

 

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In March 2016, Aralez Canada entered into a sublease agreement for an approximately 9,183 square foot office space located at 7100 West Credit Avenue, Mississauga, Ontario. The lease term is five years and three months, terminating on July 30, 2021. This location serves as the global headquarters for Aralez. Aralez Canada also owned a building located at 544 Egerton Street in London, Ontario, Canada, which it sold in March 2017.

 

In March 2016, our wholly-owned subsidiary Aralez Pharmaceuticals US Inc. (“Aralez Pharmaceuticals US”), a Delaware corporation, entered into a lease for an approximately 36,602 square foot office space located in Princeton, New Jersey. The lease term is ten years and nine months, expiring in 2027. This lease may be terminated after seven years provided we pay an early termination penalty equal to four months of rent. This location serves as the U.S. headquarters for Aralez.

 

In October 2015, Aralez Pharmaceuticals US entered into a lease for an approximately 4,500 square foot office space located in Radnor, Pennsylvania which was subsequently assigned to Aralez Pharmaceuticals Management Inc., also a wholly owned subsidiary of Aralez Pharmaceuticals Inc. The lease term is five years and two months, terminating on December 31, 2020, with a five-year extension term available at our option.

 

In September 2015, Aralez Pharmaceuticals US entered into a lease for an approximately 4,000 square foot office space located in New York, New York. The lease term is five years and two months, terminating on November 30, 2020.

 

 

ITEM 3. Legal Proceedings

 

For a discussion of legal proceedings, see Note 13 — Commitments and Contingencies to the Consolidated Financial Statements, which is incorporated herein by reference. 

 

 

ITEM 4. Mine Safety Disclosures

 

Not applicable.

52


 

 

PART II

 

ITEM 5. Market for the Registrant’s Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities

 

Market Information

 

As a result of the Merger, all of the shares of Pozen common stock issued and outstanding immediately prior to the effective time of the Merger were canceled and automatically converted into and became the right to receive our common shares on a one-for-one basis and Pozen became a wholly-owned subsidiary of Aralez.

 

Our common shares began trading on the NASDAQ Global Market under the trading symbol “ARLZ” on February 8, 2016 and on the Toronto Stock Exchange under the trading symbol “ARZ” on February 10, 2016. Previously, from October 11, 2000 until February 5, 2016, the common stock of Pozen was traded on the NASDAQ Global Market (formerly the NASDAQ National Market) under the trading symbol “POZN.” The following table sets forth the high and low sales prices per common share of Aralez from February 5, 2016 to December 31, 2017, as reported on the NASDAQ Global Market for the periods indicated.

 

 

 

 

 

 

 

 

 

 

 

Price Range

 

2017 Fiscal Year

    

High

    

Low

  

First Quarter

 

$

4.79

 

$

2.05

 

Second Quarter

 

$

2.30

 

$

1.09

 

Third Quarter

 

$

2.35

 

$

0.95

 

Fourth Quarter

 

$

2.98

 

$

1.31

 

 

 

 

 

 

 

 

 

 

 

 

Price Range

 

2016 Fiscal Year

    

High

    

Low

  

First Quarter

 

$

6.42

 

$

3.42

 

Second Quarter

 

$

4.46

 

$

3.10

 

Third Quarter

 

$

6.80

 

$

3.28

 

Fourth Quarter

 

$

5.90

 

$

3.78

 

 

Holders of Record

 

The closing price of our common shares as reported on the NASDAQ Global Market and the Toronto Stock Exchange on March 8, 2018 was $1.99 and $2.57 CAD, respectively. As of the close of business on March 8, 2018, there were approximately 1,095 holders of record of our common shares.

 

Dividends

 

We have not declared or paid any cash dividends on common shares to date. We currently intend to retain all earnings to support operations and do not intend to pay cash dividends on our common shares for the foreseeable future. In addition, our ability to pay cash dividends is currently prohibited by the Facility Agreement, subject to certain exceptions. Any future determination to pay dividends on our common shares will be made by the board of directors and will depend on, among other things, the Company’s results of operations, current and anticipated cash requirements and surplus, financial condition, contractual restrictions and financing agreement covenants, solvency tests imposed by corporate law and other factors that the board of directors may deem relevant.

 

Restrictions on Share Ownership by Non-Canadians

 

There are no limitations under the laws of Canada or in our organizational documents on the right of foreigners to hold or vote our securities, except that the Investment Canada Act may require review and approval by the Minister of Innovation, Science and Economic Development (Canada) of certain acquisitions of “control” of the Company by a “non-Canadian.”

 

53


 

Anti-Takeover Provisions

 

Our Articles provide for some general safeguards against take-over transactions, including the absence of cumulative voting rights, which allows for the holders of a majority of the common shares to elect all of the directors standing for election, and the establishment of advance notice requirements for nominations for election to the Board of Directors or for proposing matters that can be acted upon at shareholder meetings.

 

However, National Instrument 62-104 — Take-Over Bids and Issuer Bids (“NI 62-104”) is applicable to us and provides that a take-over bid is triggered when a person makes “an offer to acquire voting securities or equity securities of a class made to one or more persons … where the securities subject to the offer to acquire, together with the offeror’s securities, constitute in the aggregate 20% or more of the outstanding securities of that class of securities at the date of the offer to acquire...” When a take-over bid is triggered, an offeror must comply with certain requirements. These include, among other things, making the offer of identical consideration to all holders of the class of security that is the subject of the bid; making a public announcement of the bid in a newspaper; and sending out a bid circular to security holders which explains the terms and conditions of the bid. Directors of an issuer whose securities are the subject of a take-over bid are required to evaluate the proposed bid and circulate a directors’ circular indicating whether they recommend to accept or reject the bid or are not making a recommendation regarding the bid. Strict timelines must be adhered to.

 

The take-over bid rules also require that whenever a person acquires beneficial ownership of, or control or direction over, voting or equity securities of any class of a reporting issuer or securities convertible into voting or equity securities of any class of a reporting issuer that, together with the person’s securities of that class, would constitute 10% or more of the outstanding securities of that class, the person must file a press release announcing that fact and file an “early warning report” with applicable Canadian securities regulators. An additional news release and report must be filed at each instance (i) the person acquires or disposes beneficial ownership of securities in an amount equal to 2% or more of the outstanding securities of the class of securities that was the subject of the most recent early warning report, (ii) there is a change in a material fact contained in the most recent early warning report filed, or (iii) the person’s beneficial ownership of, or control or direction over, the outstanding securities of the class of securities that was the subject of the most recent early warning report decreases to less than 10%.

 

An “issuer bid” is defined in NI 62-104 to be “an offer to acquire or redeem securities of an issuer made by the issuer to one or more persons...” Similar requirements to a takeover bid exist for issuer bids. NI 62-104 also contains a number of exemptions to the take-over bid and issuer bid requirements.

 

In addition, Multilateral Instrument 61-101 —  Protection of Minority Securityholders in Special Transactions which governs disclosure, minority shareholder approval and valuation requirements in respect of exceptional transactions, contains detailed requirements in connection with “related party transactions.”

 

Investment Canada Act

 

An acquisition of control of a Canadian business by a non-Canadian is either reviewable (a “Reviewable Transaction”), in which case it is subject to both a reporting obligation and an approval process, or notifiable, in which case it is subject to only a reporting obligation. In the case of a Reviewable Transaction, the non-Canadian acquirer must submit an application for review with the prescribed information. The responsible Minister is then required to determine whether the Reviewable Transaction is likely to be of net benefit to Canada, taking into account the assessment factors specified in the Investment Canada Act and any written undertakings that may have been given by the non-Canadian acquirer.

 

Any investment by a non-Canadian in a Canadian business, even where control has not been acquired, can be reviewed on grounds of whether it may be injurious to national security. Where an investment is determined to be injurious to national security, Canada’s Cabinet can prohibit closing or, if closed, can order the investor to divest control. Short of a prohibition or divestment order, Canada’s Cabinet can impose terms or conditions on the investment or can require the investor to provide binding undertakings to remove the national security concern.

 

54


 

Competition Act

 

Part IX of the Competition Act (Canada) (the “Competition Act”) requires that pre-merger notification filings be submitted to the Commissioner of Competition (the “Commissioner”) in respect of certain types of transactions that exceed certain prescribed thresholds. If a proposed transaction exceeds such thresholds, subject to certain exceptions, notification filings must be submitted to the Commissioner and the statutory waiting period must expire or be terminated early or waived by the Commissioner before the transaction can be completed.

 

All mergers, regardless of whether they are subject to Part IX of the Competition Act, are subject to the substantive mergers provisions under Section 92 of the Competition Act. In particular, the Commissioner may challenge a transaction before the Competition Tribunal where the transaction prevents or lessens, or is likely to prevent or lessen, competition substantially in a market. The Commissioner may not make an application to the Competition Tribunal under Section 92 of the Competition Act more than one year after the transaction has been substantially completed.

 

Equity Compensation Plans

 

See Item 12 of Part III of this Annual Report on Form 10-K.

 

Stock Performance Graph

 

The graph below matches Aralez’s cumulative five-year total shareholder return on common shares with the cumulative total returns of the NASDAQ Composite Index, the NASDAQ Pharmaceutical Index, and the NASDAQ Biotechnology Index. The graph tracks the performance of a $100 investment in Aralez’s common shares and in each index (with the reinvestment of all dividends) from December 31, 2012 to December 31, 2017.

 

 Picture 2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    

12/2012

    

12/2013

    

12/2014

    

12/2015

    

12/2016

    

12/2017

  

Aralez Pharmaceuticals Inc.

 

100.00

 

236.61

 

235.43

 

201.00

 

129.78

 

41.79

 

NASDAQ Composite

 

100.00

 

140.12

 

160.78

 

171.97

 

187.22

 

242.71

 

NASDAQ Pharmaceutical

 

100.00

 

166.02

 

223.13

 

249.39

 

196.15

 

238.64

 

NASDAQ Biotechnology

 

100.00

 

164.86

 

215.16

 

227.68

 

177.61

 

212.45

 

 

The stock price performance included in this graph is not necessarily indicative of future stock price performance.

55


 

 

Recent Sales of Unregistered Securities

 

There were no sales of unregistered securities during the year ended December 31, 2017.

 

Issuer Purchases of Equity Securities

 

There were no repurchases of equity securities during the fourth quarter of 2017.

 

ITEM 6. Selected Financial Data

 

The following selected financial data are derived from the audited financial statements of Aralez for the years ended December 31, 2017 and 2016 and Pozen for the years ended December 31, 2015, 2014 and 2013. The data should be read in conjunction with the financial statements, related notes and other financial information included (and incorporated by reference) herein.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the Years Ended December 31,

 

 

    

2017

    

2016

    

2015

    

2014

    

2013

  

 

 

(in thousands)

 

Statement of Operations Data:

 

 

  

 

 

  

 

 

 

  

 

 

  

 

 

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenues, net

 

$

38,729

 

$

25,432

 

$

 —

 

$

 —

 

$

 —

 

Other revenues

 

 

67,218

 

 

28,838

 

 

21,391

 

 

32,394

 

$

10,322

 

Total revenues, net

 

 

105,947

 

 

54,270

 

 

21,391

 

 

32,394

 

 

10,322

 

Costs and expenses:

 

 

 

 

 

  

 

 

  

 

 

  

 

 

  

 

Cost of product revenues (exclusive of amortization shown separately below)

 

 

13,506

 

 

11,765

 

 

50,345

 

 

10,079

 

 

17,161

 

Selling, general and administrative

 

 

116,572

 

 

118,548

 

 

8,512

 

 

5,740

 

 

9,945

 

Research and development

 

 

2,324

 

 

8,832

 

 

 —

 

 

 —

 

 

 —

 

Amortization of intangible assets

 

 

34,323

 

 

12,591

 

 

 —

 

 

 —

 

 

 —

 

Change in fair value of contingent consideration

 

 

35,725

 

 

750

 

 

 —

 

 

 —

 

 

 —

 

Impairment of intangible assets

 

 

 —

 

 

4,368

 

 

 —

 

 

 —

 

 

 —

 

Total costs and expenses

 

 

202,450

 

 

156,854

 

 

58,857

 

 

15,819

 

 

27,106

 

(Loss) income from operations

 

 

(96,503)

 

 

(102,584)

 

 

(37,466)

 

 

16,575

 

 

(16,784)

 

Interest expense

 

 

(26,984)

 

 

(6,141)

 

 

 —

 

 

 —

 

 

 —

 

 Other (expense) income, net

 

 

682

 

 

5,683

 

 

(143)

 

 

3,099

 

 

76

 

(Loss) income before income tax expense

 

 

(122,805)

 

 

(103,042)

 

 

(37,609)

 

 

19,674

 

 

(16,708)

 

Provision for (benefit from) income taxes

 

 

2,400

 

 

(64)

 

 

174

 

 

 —

 

 

 —

 

Net (loss) income

 

$

(125,205)

 

$

(102,978)

 

$

(37,783)

 

$

19,674

 

$

(16,708)

 

Basic net (loss) income per common share

 

$

(1.89)

 

$

(1.67)

 

$

(1.16)

 

$

0.63

 

$

(0.55)

 

Shares used in computing basic net (loss) income per common share

 

 

66,389

 

 

61,831

 

 

32,590

 

 

31,360

 

 

30,450

 

Diluted net (loss) income per common share

 

$

(1.89)

 

$

(1.74)

 

$

(1.16)

 

$

0.60

 

$

(0.55)

 

Shares used in computing diluted net (loss) income per common share

 

 

66,389

 

 

61,883

 

 

32,590

 

 

32,811

 

 

30,450

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

 

    

2017

    

2016

    

2015

    

2014

    

2013

  

 

 

(in thousands)

 

Balance Sheet Data:

 

 

  

 

 

  

 

 

 

  

 

 

  

 

 

  

Cash and cash equivalents

 

$

28,892

 

$

64,943

 

$

24,816

 

$

40,582

 

$

32,828

 

Total assets

 

 

453,477

 

 

517,377

 

 

32,258

 

 

50,454

 

 

35,334

 

Total liabilities

 

 

438,258

 

 

397,891

 

 

17,475

 

 

3,713

 

 

17,546

 

Accumulated deficit

 

 

(362,871)

 

 

(237,666)

 

 

(134,688)

 

 

(96,904)

 

 

(116,579)

 

Total shareholders’ equity

 

 

15,219

 

 

119,486

 

 

14,783

 

 

46,741

 

 

17,789

 

 

 

56


 

ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Overview

 

Aralez is a global specialty pharmaceutical company focused on delivering meaningful products to improve patients’ lives while focusing on creating shareholder value by acquiring, developing and commercializing products primarily in cardiovascular and other specialty areas. The Company currently commercializes a number of cardiovascular products in the United States as well as products for cardiovascular, pain management, dermatological and certain other indications in Canada. In addition, the Company outlicenses certain products in exchange for royalties and/or other payments.

 

 

Results of Operations

 

Revenues

 

The following table sets forth net revenues for the periods presented:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the Years Ended December 31,

 

 

    

2017

    

2016

    

2015

  

 

 

(in thousands)

 

Product revenues, net

 

$

38,729

 

$

25,432

 

$

 —

 

Other revenues

 

 

67,218

 

 

28,838

 

 

21,391

 

Total revenues, net

 

$

105,947

 

$

54,270

 

$

21,391

 

 

Year ended December 31, 2017 compared to the year ended December 31, 2016

 

Product Revenues, net

 

Net product revenues for the year ended December 31, 2017 were $38.7 million, an increase of $13.3 million, compared to $25.4 million for the year ended December 31, 2016. The increase primarily related to sales of Zontivity, which we acquired in September 2016, as well as Yosprala (in the U.S.) and Blexten, Cambia and Soriatane (in Canada) in 2017. Beginning on March 31, 2017, we began recording revenue for Zontivity on a gross basis. Previously, sales of Zontivity were recorded in other revenues as the product was being sold on our behalf by Merck for an interim period post acquisition. Blexten and Yosprala received regulatory approval in April 2016 and September 2016, respectively, and were launched in the second half of 2016. Also contributing to the increase were net product revenues from sales of the Toprol-XL AG under the Lannett-Toprol-XL AG Agreement, which we began recording on a gross basis upon contract execution in November 2017.  All other Toprol-XL Franchise net revenues for the year ended December 31, 2017 were recorded in other revenues. Net product revenues for year ended December 31, 2016 only include sales from the date of the Tribute merger on February 5, 2016.

 

Other Revenues

 

Other revenues for the year ended December 31, 2017 were $67.2 million, an increase of $38.4 million, compared to $28.8 million for the year ended December 31, 2016. The increase related primarily to net revenues for the Toprol-XL Franchise, which we acquired in October 2016, and was sold on our behalf by AstraZeneca under a transition services agreement that expired on December 31, 2017 (other than sales under the Lannett Toprol-XL AG Agreement, as described above). Also contributing to the increase was $4.0 million in license fee revenue recognized in connection with a license agreement executed in May 2017 (pursuant to which Pozen granted a non-exclusive license to a Japanese patent), offset by a decrease in net royalties from Vimovo during the year ended December 31, 2017, compared to the prior year. 

 

Year ended December 31, 2016 compared to the year ended December 31, 2015

 

Product Revenues, net

 

Net product revenues of $25.4 million for the year ended December 31, 2016 relate to the product portfolio we acquired with the acquisition of Aralez Canada on February 5, 2016 and primarily include revenues from sales of

57


 

Bezalip, Fiorinal, Soriatane, Proferrin and Fibricor. There were no product revenues for the year ended December 31, 2015 as the acquisition of Aralez Canada occurred in February 2016.

 

Other Revenues

 

Other revenues were $28.8 million for the year ended December 31, 2016, as compared to $21.4 million for the year ended December 31, 2015. Other revenues for the year ended December 31, 2016 related primarily to royalties earned on net sales of Vimovo, and net revenues from Zontivity and the Toprol-XL Franchise from the dates of acquisition, which were sold on our behalf by Merck under a transition services agreement that expired on March 31, 2017, and AstraZeneca under a transition services agreement that expired on December 31, 2017, respectively. Other revenues for the year ended December 31, 2015 related solely to royalties earned on net sales of Vimovo.

 

Costs and Expenses

 

The following table sets forth costs and expenses for the periods presented:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the Years Ended December 31,

 

 

    

2017

    

2016

    

2015

 

 

 

(in thousands)

 

Cost of product revenues (exclusive of amortization shown separately below)

 

$

13,506

 

$

11,765

 

$

 —

 

Selling, general and administrative

 

 

116,572

 

 

118,548

 

 

50,345

 

Research and development

 

 

2,324

 

 

8,832

 

 

8,512

 

Amortization of intangible assets

 

 

34,323

 

 

12,591

 

 

 —

 

Change in fair value of contingent consideration

 

 

35,725

 

 

750

 

 

 —