`
` UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
`
`
`
`FORM 10-K
`
` (Mark One)
`ý ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`For the fiscal year ended December 31, 2015
`
`or
`
`o
`
`TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`For the transition period from to
`Commission File No. 0-19731
`
`
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`GILEAD SCIENCES, INC.
`
`(Exact name of registrant as specified in its charter)
`
`
`
`94-3047598
`Delaware
`(I.R.S. Employer Identification No.)
`(State or Other Jurisdiction of Incorporation or Organization)
`94404
`333 Lakeside Drive, Foster City, California
`(Zip Code)
`(Address of principal executive offices)
`Registrant's telephone number, including area code: 650-574-3000
`
`
`SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT:
`
`Title of each class
`Name of each exchange on which registered
`The Nasdaq Global Select Market
`Common Stock, $0.001 par value per share
`SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT: NONE
`
`
`Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x 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 x
`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 x No ¨
`Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and
`posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and
`post such files). Yes x No ¨
`Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405) 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. x
`Indicate by check mark whether registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large
`accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
`Accelerated filer ¨
`Non-Accelerated filer ¨
` (Do not check if a smaller reporting company)
`Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
`The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant based upon the closing price of its Common Stock on the Nasdaq
`Global Select Market on June 30, 2015 was $140,034,139,655.*
`The number of shares outstanding of the registrant's Common Stock on February 12, 2016 was 1,366,845,691.
`DOCUMENTS INCORPORATED BY REFERENCE
`Specified portions of the registrant's proxy statement, which will be filed with the Commission pursuant to Regulation 14A in connection with the registrant's 2016 Annual
`Meeting of Stockholders, to be held on May 11, 2016, are incorporated by reference into Part III of this Report.
`* Based on a closing price of $117.08 per share on June 30, 2015. Excludes 276,651,262 shares of the registrant's Common Stock held by executive officers, directors and any
`stockholders whose ownership exceeds 5% of registrant's common stock outstanding at June 30, 2015. Exclusion of such shares should not be construed to indicate that any
`such person possesses the power, direct or indirect, to direct or cause the direction of the management or policies of the registrant or that such person is controlled by or under
`common control with the registrant.
`
`Smaller reporting company ¨
`
`Large accelerated filer x
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`GILEAD SCIENCES, INC.
`2015 Form 10-K Annual Report
`Table of Contents
`
`PART I
`Business
`Item 1
`Item 1A Risk Factors
`Item 1B Unresolved Staff Comments
`Item 2
`Properties
`Item 3
`Legal Proceedings
`Item 4
`Mine Safety Disclosures
`
`PART II
`Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
`Item 5
`Selected Financial Data
`Item 6
`Management's Discussion and Analysis of Financial Condition and Results of Operations
`Item 7
`Item 7A Quantitative and Qualitative Disclosures about Market Risk
`Item 8
`Financial Statements and Supplementary Data
`Item 9
`Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
`Item 9A Controls and Procedures
`Item 9B Other Information
`
`PART III
`Item 10
`Item 11
`Item 12
`Item 13
`Item 14
`
`PART IV
`Item 15
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`SIGNATURES
`
`Directors, Executive Officers and Corporate Governance
`Executive Compensation
`Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
`Certain Relationships and Related Transactions, and Director Independence
`Principal Accountant Fees and Services
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`Exhibits and Financial Statement Schedules
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`We own or have rights to various trademarks, copyrights and trade names used in our business, including the following: GILEAD®, GILEAD
`SCIENCES®, AMBISOME®, CAYSTON®, COMPLERA®, EMTRIVA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPSERA®,
`LETAIRIS®, RANEXA®, RAPISCAN®, SOVALDI®, STRIBILD®, TRUVADA®, TYBOST®, VIREAD®, VITEKTA®, VOLIBRIS®, and
`ZYDELIG®. ATRIPLA® is a registered trademark belonging to Bristol-Myers Squibb & Gilead Sciences, LLC. LEXISCAN® is a registered trademark
`belonging to Astellas U.S. LLC. MACUGEN® is a registered trademark belonging to Eyetech, Inc. SUSTIVA® is a registered trademark of Bristol-Myers
`Squibb Pharma Company. TAMIFLU® is a registered trademark belonging to Hoffmann-La Roche Inc. This report also includes other trademarks, service
`marks and trade names of other companies.
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`This Annual Report on Form 10-K, including the section entitled “Management's Discussion and Analysis of Financial Condition and Results of
`Operations,” contains forward-looking statements regarding future events and our future results that are subject to the safe harbors created under the
`Securities Act of 1933, as amended (the Securities Act), and the Securities Exchange Act of 1934, as amended (the Exchange Act). Words such as “expect,”
`“anticipate,” “target,” “goal,” “project,” “hope,” “intend,” “plan,” “believe,” “seek,” “estimate,” “continue,” “may,” “could,” “should,” “might,”
`variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, any statements other than statements
`of historical fact are forward-looking statements, including statements regarding overall trends, operating cost and revenue trends, liquidity and capital
`needs and other statements of expectations, beliefs, future plans and strategies, anticipated events or trends and similar expressions. We have based these
`forward-looking statements on our current expectations about future events. These statements are not guarantees of future performance and involve risks,
`uncertainties and assumptions that are difficult to predict. Our actual results may differ materially from those suggested by these forward-looking
`statements for various reasons, including those identified in Part I, Item 1A of this Form 10-K under the heading “Risk Factors.” Given these risks and
`uncertainties, you are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements included in this report are
`made only as of the date hereof. Except as required under federal securities laws and the rules and regulations of the Securities and Exchange Commission
`(SEC), we do not undertake, and specifically decline, any obligation to update any of these statements or to publicly announce the results of any revisions
`to any forward-looking statements after the distribution of this report, whether as a result of new information, future events, changes in assumptions or
`otherwise.
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`PART I
`
`BUSINESS
`
`ITEM 1.
`Overview
`Gilead Sciences, Inc. (Gilead, we or us), incorporated in Delaware on June 22, 1987, is a research-based biopharmaceutical company that discovers,
`develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we strive
`to transform and simplify care for people with life-threatening illnesses around the world. Gilead's primary areas of focus include human immunodeficiency
`virus (HIV), liver diseases such as chronic hepatitis C virus (HCV) infection and chronic hepatitis B virus (HBV) infection, cardiovascular,
`hematology/oncology and inflammation/respiratory. We have operations in more than 30 countries worldwide, with headquarters in Foster City, California.
`We continue to add to our existing portfolio of products through our internal discovery and clinical development programs and through a product
`acquisition and in-licensing strategy.
`
`2015 Highlights
`Over the past year, we worked to bring best-in-class drugs to market that advance the standard of care by offering enhanced modes of delivery, more
`convenient treatment regimens, improved resistance profiles, reduced side effects and greater efficacy. In the HIV area, we received approval from U.S. Food
`and Drug Administration (FDA) and the European Commission of Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir
`alafenamide 10 mg or E/C/F/TAF), a once-daily single tablet regimen for the treatment of HIV-1 infection. Two other TAF-based regimens are currently under
`evaluation by FDA and the European Medicines Agency (EMA). The first is an investigational, fixed-dose combination of emtricitabine 200 mg and
`tenofovir alafenamide 25 or 10 mg (F/TAF) for use in combination with other antiretroviral agents. The second is an investigational, once-daily single tablet
`regimen that combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine 25 mg (R/F/TAF). In the liver diseases area, we received approval
`from FDA to expand the use of Harvoni® in patients with genotype 4, 5 and 6 chronic HCV infection and in patients co-infected with HIV. In addition,
`Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with
`cirrhosis. We also submitted marketing applications to FDA and the EMA for the approval of a once-daily fixed-dose combination of sofosbuvir (SOF),
`approved as Sovaldi® in December 2013, and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6
`HCV. If approved, SOF/VEL would become the first pan-genotypic, all-oral single tablet regimen for the treatment of HCV and would complement our
`current HCV portfolio of Sovaldi and Harvoni, offering high cure rates and the potential to simplify treatment and eliminate the need for HCV genotype
`testing. In the hematology/oncology area, we submitted supplemental new drug applications to FDA and the EMA for approval of Zydelig® (idelalisib) in
`combination with ofatumumab in previously-treated patients with chronic lymphocytic leukemia (CLL). Zydelig was originally approved in combination
`with rituximab for the treatment of certain patients with CLL, small lymphocytic lymphoma and follicular lymphoma, the most common type of indolent
`non-Hodgkin's lymphoma (iNHL). We also advanced our research and development pipeline, with 180 active clinical studies at the end of 2015, of which 61
`were Phase 3 clinical trials.
`
`In addition to advancing treatment options across therapeutic areas, we also enabled access to our medications for people who need them around the
`world. During 2015, we expanded our generic licensing agreements with our India-based manufacturing partners to include SOF/VEL, once approved, for
`distribution in developing countries. A pan-genotypic therapeutic option for the treatment of HCV is particularly important for developing countries, where
`genotype testing is often unreliable or not readily available. We also expanded the geographic scope of our licensing agreements with our India-based
`manufacturing partners to include 101 developing countries. In 2015, we also updated our tiered pricing strategy to make our branded HCV medicines
`available at a significantly reduced public/government price in all of these 101 countries. By making our pricing in these countries clear and transparent, we
`hope to facilitate planning and encourage a meaningful public health response to HCV.
`
`HIV Program
`Our goal is to ensure that all HIV patients can choose a single tablet regimen that is right for them. Single tablet regimens allow patients to adhere to a
`fully suppressive course of therapy more easily and consistently, which is critical for the successful management of the disease. HIV patients are living
`longer, thus facing additional health challenges to those experienced by newly diagnosed patients. We are motivated to continue improving on existing
`treatment options. The need for efficacy together with improved long-term safety has driven our development programs and the design of the studies we have
`completed and those that are planned.
`We look forward to introducing this new generation of TAF single tablet regimens that we have created to address the evolving needs of people living
`with HIV. TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of
`Viread® (tenofovir disoproxil fumarate, TDF), as well as
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`improvement in surrogate laboratory markers of renal and bone safety as compared in clinical trials to TDF in combination with other antiretroviral agents.
`With the launch of our first TAF-based regimen, Genvoya, we now have four single tablet regimens available for the treatment of HIV. Marketing approvals
`for two additional TAF-based product candidates, F/TAF and R/F/TAF, are pending in the United States and European Union. Our product candidate
`R/F/TAF has been assigned an approval date under the Prescription Drug User Fee Act (PDUFA) of March 1, 2016 and a European Commission decision is
`expected in the third quarter of 2016. F/TAF has been assigned a PDUFA date of April 7, 2016 and a European Commission decision is expected in the
`second quarter of 2016. Emtricitabine and TAF are from Gilead and rilpivirine is from Janssen Sciences Ireland UC (Janssen).
`
`In addition, we are investigating two additional TAF-based single tablet regimens; TAF, emtricitabine and GS-9883, our proprietary integrase inhibitor
`currently in Phase 3 clinical studies; and TAF, emtricitabine, cobicistat and Janssen’s darunavir (D/C/F/TAF), which is being developed and commercialized
`by Janssen.
`
`Liver Diseases
`Our goal is to advance the treatment options and standard of care for the underserved HCV market. With the approval of Sovaldi, compared to the prior
`standard of care of up to 48 weeks, the duration of treatment has been shortened to as few as 12 weeks and the need for peg-interferon (peg-IFN) injections in
`certain viral genotype populations has been reduced or eliminated completely. In 2014, we received FDA and European Commission approval of Harvoni,
`the first once-daily single tablet regimen for the treatment of HCV genotype 1 infected patients, the most prevalent genotype in the United States. We
`received approval of Harvoni in Japan in 2015. Harvoni combines the NS5A inhibitor ledipasvir with sofosbuvir and is indicated for an eight, 12 or 24 week
`treatment duration depending on prior treatment history, cirrhosis status and baseline viral load and eliminates the need for peg-IFN and RBV, which can be
`challenging to take and tolerate. In 2015, FDA expanded the use of Harvoni to include patients with genotype 4, 5 and 6 chronic HCV infection and in
`patients co-infected with HIV. In addition, Harvoni plus ribavirin for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-
`experienced, genotype 1 patients with cirrhosis.
`
`Our long term goal is to develop an oral therapy for all HCV patients across genotypes. In the fourth quarter of 2015, we submitted marketing
`applications to FDA and the EMA for the approval of a once-daily fixed-dose combination of SOF/VEL for the treatment of chronic genotype 1-6 HCV. In the
`fourth quarter of 2015, we also initiated Phase 3 clinical trials evaluating the once-daily fixed-dose combination of SOF, VEL and GS-9857, an
`investigational NS3 protease inhibitor, for the treatment of chronic genotype 1-6 HCV.
`
`We are evaluating TAF for the treatment of chronic HBV infection and based on data from two Phase 3 clinical trials, we filed marketing applications to
`FDA and the EMA in the first quarter of 2016. We are also conducting Phase 2 clinical trials of GS-9620, an oral TLR-7 agonist, and GS-4774, a Tarmogen T
`cell immunity stimulator, for the treatment of HBV.
`
`We are evaluating simtuzumab, a monoclonal antibody, for the treatment of nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis in
`Phase 2 clinical trials. We are also evaluating GS-4977, an ASK-1 inhibitor, for NASH in Phase 2 clinical trials. We are also evaluating GS-9674, a FXR
`Agonist, for NASH in Phase 1 clinical trials.
`
`Cardiovascular
`In 2015, we received FDA approval of the use of Letairis® (ambrisentan) in combination with tadalafil for the treatment of pulmonary arterial
`hypertension (PAH) (WHO Group 1) to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.
`Letairis is an endothelin receptor antagonist that was first approved in 2007 in the United States as monotherapy for PAH to improve exercise ability and
`delay clinical worsening. Tadalafil is a PDE5 inhibitor that was initially approved for PAH in the United States in 2009 to improve exercise ability.
`Eleclazine, formerly known as GS-6615, a late sodium channel inhibitor, is being evaluated in Phase 3 clinical trials for the treatment of Long QT-3
`Syndrome. Eleclazine is also being evaluated in Phase 2 clinical trials for the treatment of hypertrophic cardiomyopathy and ventricular
`tachycardia/ventricular fibrillation. We are also evaluating GS-4977, an ASK-1 inhibitor, for pulmonary arterial hypertension in Phase 2 clinical trials.
`
`Hematology/Oncology
`In the oncology area, we are seeking to expand the use of Zydelig (idelalisib), a first-in-class PI3K delta inhibitor, for the treatment of patients with
`certain blood cancers. In 2015, we submitted supplemental new drug applications with FDA and the EMA for approval of Zydelig in combination with
`ofatumumab in previously-treated patients with CLL. Idelalisib is in Phase 3 clinical trials for the treatment of patients with frontline and relapsed refractory
`CLL and relapsed refractory
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`iNHL. We plan to submit supplemental regulatory filings with FDA and the EMA for approval of Zydelig in combination with bendamustine and rituximab
`for patients with previously treated CLL in the second quarter of 2016.
`
`In the fourth quarter of 2015, we initiated Phase 3 clinical trials evaluating GS-5745, a MMP9 mAb inhibitor, for the treatment of gastric cancer. We are
`also conducting Phase 3 clinical trials evaluating momelotinib for the treatment of myleofibrosis and pancreatic cancer.
`
`Inflammation/Respiratory
`In the inflammation/respiratory area, we advanced several product candidates in clinical trials. Presatovir, formerly known as GS-5806, a fusion
`inhibitor, is currently in Phase 2 clinical trials for the treatment of respiratory syncytial virus. GS-5745, a MMP9 mAb inhibitor, is being evaluated in Phase 2
`clinical trials for ulcerative colitis and Crohn’s disease. Filgotinib, a JAK1 inhibitor, is being evaluated in Phase 2 clinical trials for rheumatoid arthritis and
`Crohn's disease.
`
`Our Products
`HIV
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`Genvoya is an oral formulation dosed once a day for the treatment of HIV-1 infection in adults. Genvoya is our fourth complete single tablet
`regimen for the treatment of HIV and is a fixed-dose combination of our antiretroviral medicines, Vitekta® (elvitegravir 85 mg and 150 mg),
`Tybost® (cobicistat), Emtriva® (emtricitabine) and TAF 10 mg. Genvoya was approved by FDA and the European Commission in November
`2015.
`Stribild® is an oral formulation dosed once a day for the treatment of HIV-1 infection in treatment-naive adults. Stribild is our third complete
`single tablet regimen for the treatment of HIV and is a fixed-dose combination of our antiretroviral medications, Vitekta, Tybost, Viread® and
`Emtriva.
`Complera®/Eviplera® is an oral formulation dosed once a day for the treatment of HIV-1 infection in adults. The product, marketed in the United
`States as Complera and in Europe as Eviplera, is our second complete single tablet regimen for the treatment of HIV and is a fixed-dose
`combination of our antiretroviral medications, Viread and Emtriva, and Janssen's non-nucleoside reverse transcriptase inhibitor, Edurant
`(rilpivirine).
`Atripla® is an oral formulation dosed once a day for the treatment of HIV infection in adults. Atripla is our first single tablet regimen for HIV
`intended as a stand-alone therapy or in combination with other antiretrovirals. It is a fixed-dose combination of our antiretroviral
`medications, Viread and Emtriva, and Bristol-Myers Squibb Company's (BMS's) non-nucleoside reverse transcriptase inhibitor, Sustiva
`(efavirenz).
`Truvada® (emtricitabine and tenofovir disoproxil fumarate) is an oral formulation dosed once a day as part of combination therapy to treat HIV
`infection in adults. It is a fixed-dose combination of our antiretroviral medications, Viread and Emtriva. FDA also approved Truvada, in
`combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk; a strategy called pre-exposure
`prophylaxis (PrEP).
`Viread is an oral formulation of a nucleotide analog reverse transcriptase inhibitor, dosed once a day as part of combination therapy to treat HIV
`infection in patients two years of age and older. The European Commission also approved the use of Viread in combination with other
`antiretroviral agents for the treatment of HIV-1 infected adolescent patients aged two to less than 18 years with nucleoside reverse transcriptase
`inhibitor resistance or toxicities precluding the use of first-line pediatric agents. Viread is also approved for the treatment of chronic HBV.
`Emtriva is an oral formulation of a nucleoside analog reverse transcriptase inhibitor, dosed once a day as part of combination therapy to treat
`HIV infection in adults. In the United States and Europe, Emtriva is also available as an oral solution approved as part of combination therapy to
`treat HIV infection in children.
`Tybost is a pharmacokinetic enhancer dosed once a day that boosts blood levels of certain HIV medicines. Tybost is indicated as a boosting
`agent for the HIV protease inhibitors atazanavir and darunavir as part of antiretroviral combination therapy in adults with HIV-1 infection.
`Vitekta is an oral formulation of an integrase inhibitor, dosed once a day as part of combination therapy to treat HIV infection in adults without
`known mutations associated with resistance to elvitegravir, the active ingredient of Vitekta. Vitekta is indicated for use as part of HIV treatment
`regimens that include a ritonavir-boosted protease inhibitor.
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`Liver Diseases
`Harvoni is an oral formulation of the NS5A inhibitor with a nucleotide analog polymerase inhibitor dosed once a day for the treatment of
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`genotypes 1, 4, 5 and 6, HCV/HIV-1 co-infection, HCV genotype 1 and 4 liver transplant recipients, and genotype 1-infected patients with
`decompensated cirrhosis. In Europe, Harvoni is also indicated for certain patients with HCV genotype 4 infection, HCV genotype 3 infection
`with cirrhosis and/or prior treatment failure and those with HCV/HIV-1 co-infection.
`Sovaldi is an oral formulation of a nucleotide analog polymerase inhibitor dosed once a day for the treatment of HCV as a component of a
`combination antiviral treatment regimen. Sovaldi’s efficacy has been established in patients with HCV genotypes 1, 2, 3 or 4 infection (in United
`States and Europe) and genotypes 5 and 6 infection (in Europe), including those with hepatocellular carcinoma meeting Milan criteria (awaiting
`liver transplantation) and those with HCV/HIV-1 co-infection.
`Viread is an oral formulation of a nucleotide analog reverse transcriptase inhibitor, dosed once a day for the treatment of chronic HBV in adults
`with compensated and decompensated liver disease. We licensed to GlaxoSmithKline Inc. (GSK) the rights to commercialize Viread for the
`treatment of chronic HBV in China, Japan and Saudi Arabia. In 2012, the European Commission approved the use of Viread for the treatment of
`chronic HBV infection in adolescent patients aged 12 to less than 18 years with compensated liver disease and evidence of immune active
`disease. Viread is also approved for the treatment of HIV infection.
`Hepsera® (adefovir dipivoxil) is an oral formulation of a nucleotide analog polymerase inhibitor, dosed once a day to treat chronic HBV in
`patients 12 years of age and older. We licensed to GSK the rights to commercialize Hepsera for the treatment of chronic HBV in Asia Pacific,
`Latin America and certain other territories.
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`Cardiovascular
`Letairis (ambrisentan) is an oral formulation of an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial
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`hypertension (PAH) (World Health Organization (WHO) Group 1) in patients with WHO Class II or III symptoms to improve exercise capacity and
`delay clinical worsening. We sublicensed to GSK the rights to ambrisentan, marketed by GSK as Volibris (ambrisentan), for PAH in territories
`outside of the United States.
`Ranexa® (ranolazine) is an extended-release tablet for the treatment of chronic angina. We have licensed to Menarini International Operations
`Luxembourg SA the rights to Ranexa in territories outside of the United States.
`Lexiscan®/Rapiscan® (regadenoson) injection is indicated for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging
`(MPI), a test that detects and characterizes coronary artery disease, in patients unable to undergo adequate exercise stress. Astellas US LLC
`(Astellas) has exclusive rights to manufacture and sell regadenoson under the name Lexiscan in the United States. Rapidscan Pharma Solutions,
`Inc. (RPS) holds the exclusive right to manufacture and sell regadenoson under the name Rapiscan in Europe and certain territories outside the
`United States. We receive royalties from Astellas and RPS for sales in these territories.
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`Hematology/Oncology
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`Zydelig is a first-in-class PI3K delta inhibitor for the treatment of certain blood cancers. In the United States, Zydelig is approved in combination
`with rituximab for patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate
`therapy and as monotherapy for patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and small lymphocytic lymphoma (SLL)
`who have received at least two prior systemic therapies. In the European Union, Zydelig is approved for the treatment of CLL and FL.
`
`Inflammation/Respiratory
`Cayston® (aztreonam for inhalation solution) is an inhaled antibiotic for the treatment of respiratory systems in cystic fibrosis (CF) patients seven
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`years of age and older with Pseudomonas aeruginosa (P. aeruginosa).
`Tamiflu® (oseltamivir phosphate) is an oral antiviral available in capsule form for the treatment and prevention of influenza A and B. Tamiflu is
`approved for the treatment of influenza in children and adults in more than 60 countries, including the United States, Japan and the European
`Union. Tamiflu is also approved for the prevention of influenza in children and adults in the United States, Japan and the European Union. We
`developed Tamiflu with F. Hoffmann-La Roche Ltd (together with Hoffmann-La Roche Inc., Roche). Roche has the
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`exclusive right to manufacture and sell Tamiflu worldwide, subject to its obligation to pay us royalties based on a percentage of the net sales of
`Tamiflu.
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`Other
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`AmBisome® (amphotericin B liposome for injection) is a proprietary liposomal formulation of amphotericin B, an antifungal agent to treat
`serious invasive fungal infections caused by various fungal species in adults. Our corporate partner, Astellas Pharma US, Inc., promotes and sells
`AmBisome in the United States and Canada, and we promote and sell AmBisome in Europe, Australia and New Zealand.
`Macugen® (pegaptanib sodium injection) is an intravitreal injection of an anti-angiogenic oligonucleotide for the treatment of neovascular age-
`related macular degeneration. Macugen was developed by Eyetech Inc. (Eyetech) using technology licensed from us and is now promoted in the
`United States by Valeant Pharmaceuticals, Inc. (Valeant), which acquired Eyetech in 2012. Valeant holds the exclusive rights to manufacture and
`sell Macugen in the United States, and Pfizer Inc. (Pfizer) holds the exclusive right to manufacture and sell Macugen in the rest of the world. We
`receive royalties from Valeant and Pfizer based on worldwide sales of Macugen.
`
`Sales of our antiviral products, which include products in our HIV and liver diseases areas described above, were $30.2 billion in 2015, $22.8 billion in
`2014 and $9.3 billion in 2013 and represented 93% of our total revenues in 2015, 92% of our total revenues in 2014 and 83% of our total revenues in
`2013. Sales of our other products were $1.9 billion in 2015, $1.7 billion in 2014 and $1.5 billion in 2013 and represented 6% of our total revenues in 2015,
`7% of our total revenues in 2014 and 13% of our total revenues in 2013. See Item 7, Management's Discussion and Analysis and Item 8, Note 15 Segment
`Information in our Consolidated Financial Statements included in this Annual Report on Form 10-K for further information related to sales by product.
`
`Commercialization and Distribution
`We have U.S. and international commercial sales operations, with marketing subsidiaries in over 30 countries. Our products are marketed through our
`commercial teams and/or in conjunction with third-party distributors and corporate partners. Our commercial teams promote our products through direct field
`contact with physicians, hospitals, clinics and other healthcare providers. We generally grant our third-party distributors the exclusive right to promote our
`product in a territory for a specified period of time. Most of our agreements with these distributors provide for collaborative efforts between the distributor
`and Gilead in obtaining and maintaining regulatory approval for the product in the specified territory.
`
`We sell and distribute Harvoni, Sovaldi, Truvada, Atripla, Stribild, Complera, Viread, Genvoya, Emtriva, Tybost, Vitekta, Ranexa, AmBisome, Zydelig
`and Hepsera in the United States exclusively through the wholesale channel. Our product sales to three large wholesalers, Cardinal Health, Inc., McKesson
`Corporation and AmerisourceBergen Corporation, each accounted for more than 10% of total revenues for each of the years ended December 31, 2015, 2014
`and 2013. On a combined basis, in 2015, these wholesalers accounted for approximately 89% of our product sales in the United States and approximately
`58% of our total worldwide revenues. Letairis and Cayston are distributed exclusively by specialty pharmacies. These specialty pharmacies dispense
`medications for complex or chronic conditions that require a high level of patient education and ongoing counseling. We sell and distribute Harvoni,
`Sovaldi, Truvada