These terms and conditions govern your use of the website alphaminr.com and its related services.
These Terms and Conditions (“Terms”) are a binding contract between you and Alphaminr, (“Alphaminr”, “we”, “us” and “service”). You must agree to and accept the Terms. These Terms include the provisions in this document as well as those in the Privacy Policy. These terms may be modified at any time.
Your subscription will be on a month to month basis and automatically renew every month. You may terminate your subscription at any time through your account.
We will provide you with advance notice of any change in fees.
You represent that you are of legal age to form a binding contract. You are responsible for any
activity associated with your account. The account can be logged in at only one computer at a
time.
The Services are intended for your own individual use. You shall only use the Services in a
manner that complies with all laws. You may not use any automated software, spider or system to
scrape data from Alphaminr.
Alphaminr is not a financial advisor and does not provide financial advice of any kind. The service is provided “As is”. The materials and information accessible through the Service are solely for informational purposes. While we strive to provide good information and data, we make no guarantee or warranty as to its accuracy.
TO THE EXTENT PERMITTED BY APPLICABLE LAW, UNDER NO CIRCUMSTANCES SHALL ALPHAMINR BE LIABLE TO YOU FOR DAMAGES OF ANY KIND, INCLUDING DAMAGES FOR INVESTMENT LOSSES, LOSS OF DATA, OR ACCURACY OF DATA, OR FOR ANY AMOUNT, IN THE AGGREGATE, IN EXCESS OF THE GREATER OF (1) FIFTY DOLLARS OR (2) THE AMOUNTS PAID BY YOU TO ALPHAMINR IN THE SIX MONTH PERIOD PRECEDING THIS APPLICABLE CLAIM. SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL OR CERTAIN OTHER DAMAGES, SO THE ABOVE LIMITATION AND EXCLUSIONS MAY NOT APPLY TO YOU.
If any provision of these Terms is found to be invalid under any applicable law, such provision shall not affect the validity or enforceability of the remaining provisions herein.
This privacy policy describes how we (“Alphaminr”) collect, use, share and protect your personal information when we provide our service (“Service”). This Privacy Policy explains how information is collected about you either directly or indirectly. By using our service, you acknowledge the terms of this Privacy Notice. If you do not agree to the terms of this Privacy Policy, please do not use our Service. You should contact us if you have questions about it. We may modify this Privacy Policy periodically.
When you register for our Service, we collect information from you such as your name, email address and credit card information.
Like many other websites we use “cookies”, which are small text files that are stored on your computer or other device that record your preferences and actions, including how you use the website. You can set your browser or device to refuse all cookies or to alert you when a cookie is being sent. If you delete your cookies, if you opt-out from cookies, some Services may not function properly. We collect information when you use our Service. This includes which pages you visit.
We use Google Analytics and we use Stripe for payment processing. We will not share the information we collect with third parties for promotional purposes. We may share personal information with law enforcement as required or permitted by law.
|
|
ý
|
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
|
Delaware
|
94-3047598
|
(State or Other Jurisdiction of Incorporation or Organization)
|
(I.R.S. Employer Identification No.)
|
333 Lakeside Drive, Foster City, California
|
94404
|
(Address of principal executive offices)
|
(Zip Code)
|
|
Title of each class
|
Name of each exchange on which registered
|
Common Stock, $0.001 par value per share
|
The Nasdaq Global Select Market
|
|
Large accelerated filer
x
|
Accelerated filer
¨
|
Non-Accelerated filer
¨
|
Smaller reporting company
¨
|
(Do not check if a smaller reporting company)
|
|
PART I
|
|
|
Item 1
|
||
Item 1A
|
||
Item 1B
|
||
Item 2
|
||
Item 3
|
||
Item 4
|
||
|
|
|
PART II
|
|
|
Item 5
|
||
Item 6
|
||
Item 7
|
||
Item 7A
|
||
Item 8
|
||
Item 9
|
||
Item 9A
|
||
Item 9B
|
||
|
|
|
PART III
|
|
|
Item 10
|
||
Item 11
|
||
Item 12
|
||
Item 13
|
||
Item 14
|
||
|
|
|
PART IV
|
|
|
Item 15
|
||
|
|
|
ITEM 1.
|
BUSINESS
|
|
|
Treatment
|
|
Duration
|
Genotype 1 or 4
|
|
Sovaldi + peg-IFN + RBV
|
|
12 weeks
|
Genotype 2
|
|
Sovaldi + RBV
|
|
12 weeks
|
Genotype 3
|
|
Sovaldi + RBV
|
|
12 weeks
|
Hepatocellular carcinoma awaiting liver transplantation
|
|
Sovaldi + RBV
|
|
48 weeks or until liver transplant
|
•
|
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 regimen for the treatment of HIV and is a fixed-dose combination of our antiretroviral medications, Vitekta, Tybost, Viread and Emtriva
®
(emtricitabine). Stribild was approved by the FDA in August 2012 and the EMA in May 2013.
|
•
|
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 the 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 the first once-daily 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) 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. In 2012, the 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. In 2012, the European Commission also approved the use of Viread in combination with other antiretroviral agents for the treatment of HIV-1 infected pediatric 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 in adults.
|
•
|
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. We received marketing approval of Tybost in all 28 countries of the European Union.
|
•
|
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. We received marketing approval of Vitekta in all 28 countries of the European Union.
|
•
|
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 was approved by the FDA in December 2013 and by the European Commission in January 2014. 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
|
•
|
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 EMA 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 in patients two years of age and older in combination with other antiretroviral agents.
|
•
|
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.
|
•
|
Letairis
®
(ambrisentan) is an oral formulation of an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH) (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, subject to its obligations to pay us royalties based on sales of Lexiscan in the U.S. 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.
|
•
|
Cayston
®
(aztreonam for inhalation solution) is an inhaled antibiotic for the treatment of respiratory systems in cystic fibrosis (CF) patients seven 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 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.
|
•
|
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.
|
•
|
Vistide
®
(cidofovir injection) is an antiviral injection for the treatment of cytomegalovirus retinitis in adult patients with AIDS.
|
•
|
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.
|
•
|
PharmaChem Technologies (Grand Bahama), Ltd (PharmaChem).
In 2005, PharmaChem, one of our commercial manufacturing partners, established a facility in The Bahamas to manufacture tenofovir disoproxil fumarate, the active pharmaceutical ingredient in Viread and one of the active pharmaceutical ingredients in Atripla and Truvada, for resource limited countries through a cooperative effort with PharmaChem and the Grand Bahama Port Authority.
|
•
|
Aspen Pharmacare Holdings Ltd (Aspen).
In 2005, we entered into a non-exclusive manufacturing and distribution agreement with Aspen, providing for the manufacture and distribution of Viread and Truvada for the treatment of HIV infection to certain developing world countries included in our Gilead Access Program. In 2007, we amended our agreement with Aspen. Under the amended agreement, Aspen retained the right to manufacture and distribute Viread and Truvada for the treatment of HIV infection in these developing world countries. Aspen has the right to purchase Viread and Truvada in unlabeled bottles from us for distribution in such countries, and also has the right to manufacture Viread and Truvada using active pharmaceutical ingredient that has been purchased by Aspen from suppliers approved by us. Aspen was also granted the right to manufacture and distribute generic versions of emtricitabine and tenofovir disoproxil fumarate, including versions of tenofovir disoproxil fumarate in combination with emtricitabine for the treatment of HIV infection. Aspen is required to pay us royalties on net sales of Viread and Truvada, as well as royalties on net sales of generic versions of tenofovir disoproxil fumarate, including versions of tenofovir disoproxil fumarate in combination with generic versions of emtricitabine that are manufactured and distributed by Aspen.
|
•
|
Licenses with Generic Manufacturers.
We have entered into non-exclusive license agreements with Indian generic manufacturers, granting them rights to produce and distribute generic versions of tenofovir disoproxil fumarate for the treatment of HIV infection to low income countries around the world, which includes India and many of the low income countries in our Gilead Access Program. The agreements require that the generic manufacturers meet certain national and international regulatory and quality standards and include technology transfers to enable expeditious production of large volumes of high quality generic versions of tenofovir disoproxil fumarate. In addition, these agreements allow for the manufacture of commercial quantities of both active pharmaceutical ingredient and finished product. In 2011, we expanded these non-exclusive license agreements to increase the number of countries included in the license, and also to include rights to cobicistat and elvitegravir, including generic versions of our combination product containing the four active ingredients of cobicistat, elvitegravir, tenofovir disoproxil fumarate and emtricitabine. We also included in these non-exclusive license agreements the ability to manufacture and distribute generic versions of tenofovir disoproxil fumarate for the treatment of HBV in the same countries where they are authorized to sell generic versions of tenofovir disoproxil fumarate for HIV. In August 2012, we announced new collaborations with Indian partners to produce and distribute generic emtricitabine in the developing world, including single tablet regimens containing emtricitabine and fixed-dose combinations of emtricitabine co-formulated with other Gilead HIV medicines.
|
•
|
Merck & Co., Inc. (Merck).
In 2006, we entered into an agreement with an affiliate of Merck pursuant to which Gilead and Merck provide Atripla at substantially reduced prices to HIV infected patients in developing countries in Africa, the Caribbean, Latin America and Southeast Asia. Under the agreement, we manufacture Atripla using efavirenz supplied by Merck, and Merck handles distribution of the product in the countries covered by the agreement. In 2008, we also entered into an agreement with Merck to commercialize Atripla in over 30 low-middle income countries, including Brazil, Egypt and Mexico.
|
•
|
International Partnership for Microbicides (IPM) and CONRAD.
In 2006, we entered into an agreement under which we granted rights to IPM and CONRAD, a cooperating agency of the U.S. Agency for International Development committed to improving reproductive health by expanding the contraceptive choices of women and men, to develop, manufacture, and, if proven efficacious, arrange for the distribution in resource limited countries of certain formulations of tenofovir for use as a topical microbicide to prevent HIV infection.
|
•
|
Medicines Patent Pool (the Pool)
. In 2011, we entered into an agreement with the Pool, an organization that was established by the United Nations to increase global access to high-quality, low-cost antiretroviral therapy through the sharing of patents. We granted the Pool a non-exclusive license to identify generic pharmaceutical manufacturers in India who specialize in high-quality production of generic medicines and granted sublicenses to those Indian manufacturers to manufacture and distribute generic versions of our antiretrovirals in the developing world. Sublicensees through the Pool will be free to develop combination products and pediatric formulations of our HIV medicines. We also granted the Pool the right to grant sublicenses to generic versions of the single tablet regimen consisting of elvitegravir, cobicistat, tenofovir disoproxil fumarate and emtricitabine and to our product candidates, elvitegravir and cobicistat, to those same generic pharmaceutical manufacturers in India for distribution in the developing world.
|
•
|
Janssen
. In 2011, we expanded our agreement with Janssen to provide for distribution of Complera/Eviplera for the treatment of HIV in less developed countries and to enable the commercialization of generic versions of the product.
|
•
|
efficacy;
|
•
|
safety;
|
•
|
tolerability;
|
•
|
acceptance by doctors;
|
•
|
ease of patient compliance;
|
•
|
patent protection;
|
•
|
ease of use;
|
•
|
price;
|
•
|
insurance and other reimbursement coverage;
|
•
|
distribution; and
|
•
|
marketing.
|
•
|
BMS.
In 2004, we entered into a collaboration arrangement with BMS to develop and commercialize the single tablet regimen of our Truvada and BMS's Sustiva (efavirenz) in the United States. This combination was approved for use in the United States in 2006 and is sold under the brand name Atripla. We and BMS structured this collaboration as a joint venture that operates as a limited liability company named Bristol-Myers Squibb & Gilead Sciences, LLC, which we consolidate. We and BMS granted royalty-free sublicenses to the joint venture for the use of our respective company owned technologies and, in return, were granted a license by the joint venture to use any intellectual property that results from the collaboration. In 2006, we and BMS amended the joint venture's collaboration agreement to allow the joint venture to sell Atripla in Canada.The economic interests of the joint venture held by us and BMS (including share of revenues and out-of-pocket expenses) are based on the portion of the net selling price of Atripla attributable to efavirenz and Truvada. Since the net selling price for Truvada may change over time relative to the net selling price of efavirenz, both our and BMS's respective economic interests in the joint venture may vary annually. Starting in 2011, except for a limited number of activities that are jointly managed, the parties no longer coordinate detailing and promotional activities in the United States, and the parties have reduced their joint promotional efforts since we launched Complera in August 2011 and Stribild in August 2012. The agreement will continue until terminated by the mutual agreement of the parties. In addition, either party may terminate the other party's participation in the collaboration within 30 days after the launch of at least one generic version of such other party's single agent products (or the double agent products). The terminating party then has the right to continue to sell Atripla and become the continuing party, but will be obligated to pay the terminated party certain royalties for a three-year period following the effective date of the termination.
|
•
|
Janssen.
In 2009, we entered into a collaboration agreement with Janssen to develop and commercialize a fixed-dose combination of our Truvada and Janssen's rilpivirine. This combination was approved in the United States and European Union in 2011 and is sold under the brand name Complera in the United States and Eviplera in the European Union. Under the agreement, Janssen granted us an exclusive license to Complera/Eviplera worldwide excluding certain middle income and developing world countries and Japan. Neither party is restricted from combining its drugs with any other drug products.
|
•
|
Japan Tobacco.
In 2005, we entered into a licensing agreement with Japan Tobacco, under which Japan Tobacco granted us exclusive rights to develop and commercialize elvitegravir, a novel HIV integrase inhibitor, in all countries of the world, excluding Japan, where Japan Tobacco would retain such rights. Under the agreement, we are responsible for seeking regulatory approval in our territories and are required to use diligent efforts to commercialize elvitegravir for the treatment of HIV infection. We bear all costs and expenses associated with such commercialization efforts. Under the terms of the agreement, we paid an up-front license fee of $15.0 million and are obligated to make total potential milestone payments of up to $90.0 million upon the achievement of certain clinical, regulatory and commercial objectives. Additionally, we are obligated to pay royalties based on any net sales in the territories where we market the product. Through
December 31, 2013
, we have made total milestone payments of $60.0 million. The agreement and our obligation to pay royalties to Japan Tobacco will terminate on a product-by-product basis as patents providing exclusivity for the product expire or, if later, on the tenth anniversary of commercial launch for such product. We may terminate the agreement for any reason in which case the license granted by Japan Tobacco to us would terminate. Either party may terminate the agreement in response to a material breach by the other party.
|
Product Candidates
|
|
Description
|
Marketing Application Pending
|
|
|
Cobicistat
|
|
Cobicistat is a pharmacokinetic enhancer dosed once a day that boosts blood levels of certain HIV medicines. It was approved as a component of Stribild. In September 2013, the European Commission approved cobicistat, marketed as Tybost, as a stand- alone boosting agent for the HIV protease inhibitors atazanavir and darunavir as part of antiretroviral combination therapy in adults with HIV-1 infection.
|
Elvitegravir
|
|
Elvitegravir is an oral integrase inhibitor dosed once a day as part of combination therapy to treat HIV infection in adults. It was approved as a component of Stribild. In November 2013, the European Commission approved elvitegravir, marketed as Vitekta for the treatment of HIV infection in adults without known mutations associated with resistance to elvitegravir. Vitekta is indicated for use as part of HIV treatment regimens that include a ritonavir-boosted protease inhibitor.
|
Product in Phase 3
|
|
|
Single tablet regimen of TAF, elvitegravir, cobicistat and emtricitabine
|
|
A single tablet regimen of TAF, an NRTI, elvitegravir, cobicistat and emtricitabine is being evaluated for the treatment of HIV infection in treatment-naïve adults.
|
Product in Phase 2
|
|
|
Single tablet regimen of TAF, darunavir, cobicistat and emtricitabine
|
|
Under an agreement with Janssen, a single tablet regimen of TAF, darunavir, cobicistat and emtricitabine is being evaluated for the treatment of HIV infection.
|
Product Candidates
|
|
Description
|
Marketing Application Pending
|
|
|
Fixed-dose combination of
LDV/SOF
|
|
A fixed-dose combination of ledipasvir, an oral NS5A inhibitor, and sofosbuvir taken with and without RBV is under evaluation in Phase 3 trials for the treatment of HCV.
|
Products in Phase 3
|
|
|
TAF
|
|
TAF is an NRTI under evaluation for the treatment of HBV.
|
Products in Phase 2
|
|
|
Fixed-dose combination of sofosbuvir and GS-5816
|
|
A fixed-dose combination of sofosbuvir and GS-5816, a nucleotide NS5B inhibitor/pan-genotypic NS5A inhibitor, being evaluated for the treatment of HCV.
|
GS-4774
|
|
GS-4774 is a Tarmogen T cell immunity stimulator under evaluation for the treatment of HBV.
|
GS-9451
|
|
GS-9451 is an oral NS3 protease inhibitor being evaluated for the treatment of HCV.
|
GS-9669
|
|
GS-9669 is a non-nucleoside NS5B site 2 polymerase inhibitor under evaluation for the treatment of HCV.
|
Simtuzumab (GS-6624)
|
|
Simtuzumab is a monoclonal antibody being evaluated for the treatment of liver fibrosis, nonalcoholic steatohepatitis and primary sclerosing cholangitis.
|
Products in Phase 1
|
|
|
GS-5745
|
|
GS-5745 is a MMP9 mAb inhibitor being evaluated for the treatment of ulcerative colitis.
|
GS-9620
|
|
GS-9620 is an oral TLR-7 agonist being evaluated for the treatment of HBV and HCV.
|
Product Candidates
|
|
Description
|
Marketing Application Pending
|
|
|
Idelalisib
|
|
Idelalisib is a PI3K delta inhibitor antibody for the treatment of iNHL and CLL. In September 2013, we submitted an NDA to the FDA for approval of idelalisib for the treatment of iNHL. The FDA has set a target review date under the PDUFA of September 11, 2014. In December 2013, we submitted an NDA to the FDA for approval of idelalisib for the treatment of CLL. The PDUFA date for the filing is August 6, 2014. Our marketing authorization application for idelalisib for iNHL and CLL was validated by the EMA in November 2013.
|
Products in Phase 3
|
|
|
Momelotinib (GS-0387/CYT387)
|
|
Momelotinib or GS-0387, formerly known as CYT387, is a JAK inhibitor being evaluated for the treatment of myelofibrosis.
|
Products in Phase 2
|
|
|
GS-9820
|
|
GS-9820 is a PI3K delta inhibitor being evaluated for the potential treatment of lymphoid malignancies.
|
GS-9973
|
|
GS-9973 is a spleen tyrosine kinase (Syk) inhibitor being evaluated with hematological malignancies.
|
Simtuzumab
|
|
Simtuzumab is a monoclonal antibody being evaluated for the treatment of myelofibrosis, colorectal and pancreatic cancer.
|
Products in Phase 1
|
|
|
GS-5745
|
|
GS-5745 is a MMP9 maB inhibitor being evaluated for the treatment of solid tumors.
|
Product Candidates
|
|
Description
|
Product in Phase 3
|
|
|
Ranolazine
|
|
Ranolazine is a late sodium current inhibitor approved for the treatment of chronic angina, which is being evaluated for the treatment of incomplete revascularization post-percutaneous coronary intervention and the treatment of type II diabetes.
|
Product in Phase 2
|
|
|
Ranolazine
|
|
Ranolazine is also being evaluated for the treatment of paroxysmal atrial fibrillation.
|
Product in Phase 1
|
|
|
GS-4997
|
|
GS-4977 is an ASK-1 inhibitor being evaluated for the treatment of diabetic nephropathy.
|
GS-6615
|
|
GS-6615 is a late sodium current inhibitor being evaluated for the treatment of LQT-3 Syndrome, hypertrophic cardiomyopathy and ventricular tachycardia/ventricular fibrillation.
|
Product Candidates
|
|
Description
|
Product in Phase 2
|
|
|
GS-5806
|
|
GS-5806 is an
inhalable small molecule antiviral fusion inhibitor
being evaluated for the treatment of respiratory syncytial virus.
|
Simtuzumab
|
|
Simtuzumab is a monoclonal antibody being evaluated for the treatment of idiopathic pulmonary fibrosis.
|
Year
|
|
Company
|
|
Therapeutic area
|
2011
|
|
Arresto Biosciences, Inc.
|
|
Fibrotic diseases and cancer
|
2011
|
|
Calistoga Pharmaceuticals, Inc.
|
|
Cancer and inflammatory diseases
|
2012
|
|
Pharmasset, Inc.
|
|
Chronic HCV
|
2013
|
|
YM Biosciences Inc.
|
|
Hematological and immune cell disorders and inflammatory diseases and cancers
|
Phase 3 Product Candidates
|
|
Patent Expiration
|
||||
Product Candidates for the Treatment of HIV
|
|
U.S.
|
|
E.U.
|
|
|
Single tablet regimen of TAF, elvitegravir, cobicistat and emtricitabine
|
|
2029
|
|
(2027)
|
|
|
Single tablet regimen of TAF and emtricitabine
|
|
2022
|
|
(2021)
|
|
|
|
|
|
|
|
|
|
Product Candidate for the Treatment of Liver Diseases
|
|
|
|
|
|
|
Single tablet regimen of LDV/SOF for the treatment of HCV
|
|
2030
|
|
(2030)
|
|
|
Single agent TAF for the treatment of HBV
|
|
2022
|
|
(2021)
|
|
|
|
|
|
|
|
|
|
Product Candidate for the Treatment of Oncology/Inflammation
|
|
|
|
|
|
|
Idelalisib for the treatment of CLL and iNHL
|
|
2025
|
|
(2025)
|
|
|
Momelotinib for the treatment of myelofibrosis
|
|
2030
|
|
(2028)
|
|
|
Product Candidate for the Treatment of Cardiovascular Diseases
|
|
|
|
|
|
|
Ranolazine for the treatment of incomplete revascularization post-percutaneous
coronary intervention and the treatment of type II diabetes
|
|
2019
|
|
2019
|
|
|
|
|
|
|
|
|
|
Dates in parentheses reflect the estimated expiration date of patents which may issue from currently pending applications. The estimated expiration dates do not include any potential additional exclusivity (e.g., patent term extension, supplementary protection certificates or pediatric exclusivity) that is not yet granted.
|
Products
|
|
Patent Expiration
|
||||
|
|
|
U.S.
|
|
E.U.
|
|
Vistide
|
|
2010
|
|
2012
|
|
|
Hepsera
|
|
2014
|
|
2016
|
|
|
AmBisome
|
|
2016
|
|
2008
|
|
|
Macugen
|
|
2017
|
|
2017
|
|
|
Tamiflu
|
|
2017
|
|
2016
|
|
|
Letairis
|
|
2018
|
|
2020
|
|
|
Viread
|
|
2018*
|
|
2018
|
|
|
Ranexa
|
|
2019**
|
|
2023
|
|
|
Atripla
|
|
2021
|
|
2018
|
|
|
Cayston
|
|
2021
|
|
2021
|
|
|
Emtriva
|
|
2021
|
|
2016
|
|
|
Truvada
|
|
2021
|
|
2018
|
|
|
Lexiscan
|
|
2022
|
|
2025
|
|
|
Complera/Eviplera
|
|
2023
|
|
2022
|
|
|
Vitekta
|
|
***
|
|
2023
|
|
|
Sovaldi
|
|
2029
|
|
(2028)
|
|
|
Stribild
|
|
2029
|
|
(2027)
|
|
|
Tybost
|
|
***
|
|
(2027)
|
|
|
|
|
|
|
|
|
|
Dates in parentheses reflect the estimated expiration date of patents which may issue from currently pending applications. The estimated expiration dates do not include any potential additional exclusivity (e.g., patent term extension, supplementary protection certificates or pediatric exclusivity) that is not yet granted.
|
|
|
*
|
In 2013, Gilead and Teva Pharmaceuticals (Teva) reached an agreement in principle to settle the ongoing patent litigation concerning the four patents that protect tenofovir disoproxil fumarate in our Viread, Truvada and Atripla products. Under the agreement, Teva will be allowed to launch a generic version of Viread on December 15, 2017. The settlement agreement was filed with the Federal Trade Commission and Department of Justice as required by law.
|
**
|
In 2013, Gilead and Lupin Limited (Lupin) reached an agreement to settle the patent litigation prior to issuance of the court’s decision. Under the agreement, Lupin would be allowed to launch a generic version of Ranexa on February 27, 2019. The settlement agreement was filed with the Federal Trade Commission and Department of Justice as required by law.
|
•
|
Phase 1. The drug candidate is given to a small number of healthy human control subjects or patients suffering from the indicated disease, to test for safety, dose tolerance, pharmacokinetics, metabolism, distribution and excretion.
|
•
|
Phase 2. The drug candidate is given to a limited patient population to determine the effect of the drug candidate in treating the disease, the best dose of the drug candidate, and the possible side effects and safety risks of the drug candidate. It is not uncommon for a drug candidate that appears promising in Phase 1 clinical trials to fail in the more rigorous Phase 2 clinical trials.
|
•
|
Phase 3. If a drug candidate appears to be effective and safe in Phase 2 clinical trials, Phase 3 clinical trials are commenced to confirm those results. Phase 3 clinical trials are conducted over a longer term, involve a significantly larger population, are conducted at numerous sites in different geographic regions and are carefully designed to provide reliable and conclusive data regarding the safety and benefits of a drug candidate. It is not uncommon for a drug candidate that appears promising in Phase 2 clinical trials to fail in the more rigorous and extensive Phase 3 clinical trials.
|
•
|
our minimum base rebate amount owed to Medicaid on products reimbursed by Medicaid increased by 8%, and the discounts or rebates we owe to ADAPs and other Public Health Service entities which reimburse or purchase our products also increased by 8%;
|
•
|
we are required to extend rebates to patients receiving our products through Medicaid managed care organizations; and
|
•
|
we are required to provide a 50% discount on products sold to patients while they are in the Medicare Part D “donut hole.”
|
ITEM 1A.
|
RISK FACTORS
|
•
|
As our HIV products are used over a longer period of time in many patients and in combination with other products, and additional studies are conducted, new issues with respect to safety, resistance and interactions with other drugs may arise, which could cause us to provide additional warnings or contraindications on our labels, narrow our approved indications or halt sales of a product, each of which could reduce our revenues.
|
•
|
As our HIV products mature, private insurers and government payers often reduce the amount they will reimburse patients for these products, which increases pressure on us to reduce prices.
|
•
|
A large part of the market for our HIV products consists of patients who are already taking other HIV drugs. If we are not successful in encouraging physicians to change patients' regimens to include our HIV products, the sales of our HIV products will be limited.
|
•
|
As generic HIV products are introduced into major markets, our ability to maintain pricing and market share may be affected. For example, generic versions of Sustiva (efavirenz), a component of our Atripla, are now available in Canada and Europe and we expect competition from generic efavirenz in the United States in 2015. This may increase pricing pressure on our HIV products. Tivicay (dolutegravir), an integrase inhibitor, launched in the fourth quarter by ViiV Healthcare (ViiV) could impact sales of our HIV products.
|
•
|
our minimum base rebate amount owed to Medicaid on products reimbursed by Medicaid increased by 8%, and the discounts or rebates we owe to ADAPs and other Public Health Service entities which reimburse or purchase our products also increased by 8%;
|
•
|
we are required to extend rebates to patients receiving our products through Medicaid managed care organizations;
|
•
|
we are required to provide a 50% discount on products sold to patients while they are in the Medicare Part D “donut hole;” and
|
•
|
we, along with other pharmaceutical manufacturers of branded drug products, were required to pay a portion of a new industry fee (also known as the pharmaceutical excise tax) of $2.8 billion for 2013, calculated based on select government sales during the 2011 calendar year as a percentage of total industry government sales.
|
•
|
we are unable to control the resources our corporate partners devote to our programs or products;
|
•
|
disputes may arise with respect to the ownership of rights to technology developed with our corporate partners;
|
•
|
disagreements with our corporate partners could cause delays in, or termination of, the research, development or commercialization of product candidates or result in litigation or arbitration;
|
•
|
contracts with our corporate partners may fail to provide significant protection or may fail to be effectively enforced if one of these partners fails to perform;
|
•
|
our corporate partners have considerable discretion in electing whether to pursue the development of any additional products and may pursue alternative technologies or products either on their own or in collaboration with our competitors;
|
•
|
our corporate partners with marketing rights may choose to pursue competing technologies or to devote fewer resources to the marketing of our products than they do to products of their own development; and
|
•
|
our distributors and our corporate partners may be unable to pay us, particularly in light of current economic conditions.
|
•
|
not provide us with accurate or timely information regarding their inventories, patient data or safety complaints;
|
•
|
not effectively sell or support Cayston or Letairis;
|
•
|
not devote the resources necessary to sell Cayston or Letairis in the volumes and within the time frames that we expect;
|
•
|
not be able to satisfy their financial obligations to us or others; or
|
•
|
cease operations.
|
•
|
obtain patents and licenses to patent rights;
|
•
|
preserve trade secrets;
|
•
|
defend against infringement and efforts to invalidate our patents; and
|
•
|
operate without infringing on the intellectual property of others.
|
|
|
December 31, 2013
|
||||||
|
|
Greater than
120 days past due
|
|
Greater than
365 days past due
|
||||
Spain
|
|
$
|
286,477
|
|
|
$
|
136,712
|
|
Portugal
|
|
55,920
|
|
|
12,231
|
|
||
Italy
|
|
53,983
|
|
|
25,971
|
|
||
Greece
|
|
6,015
|
|
|
745
|
|
||
Total
|
|
$
|
402,395
|
|
|
$
|
175,659
|
|
ITEM 1B.
|
UNRESOLVED STAFF COMMENTS
|
ITEM 2.
|
PROPERTIES
|
ITEM 3.
|
LEGAL PROCEEDINGS
|
ITEM 4.
|
MINE SAFETY DISCLOSURES
|
ITEM 5.
|
MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
|
|
|
High
|
|
Low
|
2013
|
|
|
|
|
First Quarter
|
|
$49.48
|
|
$36.94
|
Second Quarter
|
|
$58.07
|
|
$46.53
|
Third Quarter
|
|
$64.74
|
|
$51.42
|
Fourth Quarter
|
|
$76.11
|
|
$58.81
|
2012
|
|
|
|
|
First Quarter
|
|
$28.02
|
|
$20.93
|
Second Quarter
|
|
$26.36
|
|
$22.71
|
Third Quarter
|
|
$33.88
|
|
$25.33
|
Fourth Quarter
|
|
$38.17
|
|
$32.43
|
(1)
|
This section is not “soliciting material,” is not deemed “filed” with the SEC and is not to be incorporated by reference in any of our filings under the Securities Act or the Exchange Act whether made before or after the date hereof and irrespective of any general incorporation language in any such filing.
|
(2)
|
Shows the cumulative return on investment assuming an investment of $100 in our common stock, the NBI Index and the S&P 500 Index on December 31, 2008.
|
|
|
Total Number of
Shares Purchased
|
|
Average Price
Paid per Share
|
|
Total Number of
Shares Purchased
as Part of Publicly
Announced
Program
|
(1)
|
Maximum Fair
Value of Shares
that May Yet Be Purchased Under
the Program
|
(1)
|
||||||
October 1 - October 31, 2013
|
|
2,561
|
|
|
$
|
65.28
|
|
|
2,511
|
|
|
$
|
3,583,884
|
|
|
November 1 - November 30, 2013
|
|
2,212
|
|
|
$
|
69.86
|
|
|
1,938
|
|
|
$
|
3,447,902
|
|
|
December 1 - December 31, 2013
|
|
1,403
|
|
|
$
|
72.44
|
|
|
1,381
|
|
|
$
|
3,347,876
|
|
|
Total
|
|
6,176
|
|
(2)
|
$
|
68.55
|
|
|
5,830
|
|
(2)
|
|
|
|
(1)
|
In January 2011, we announced that our Board authorized a three-year, $5.00 billion stock repurchase program, which will expire in September 2014.
|
(2)
|
The difference between the total number of shares purchased and the total number of shares purchased as part of publicly announced programs is due to shares of common stock withheld by us from employee restricted stock awards in order to satisfy our applicable tax withholding obligations.
|
ITEM 6.
|
SELECTED FINANCIAL DATA
|
|
Year Ended December 31,
|
||||||||||||||||||
|
2013
|
|
2012
|
|
2011
|
|
2010
|
|
2009
|
||||||||||
CONSOLIDATED STATEMENT OF INCOME DATA:
|
|
|
|
|
|
|
|
|
|
||||||||||
Total revenues
|
$
|
11,201,688
|
|
|
$
|
9,702,517
|
|
|
$
|
8,385,385
|
|
|
$
|
7,949,420
|
|
|
$
|
7,011,383
|
|
Total costs and expenses
(1)
|
$
|
6,677,689
|
|
|
$
|
5,692,342
|
|
|
$
|
4,595,544
|
|
|
$
|
3,987,198
|
|
|
$
|
3,482,162
|
|
Income from operations
|
$
|
4,523,999
|
|
|
$
|
4,010,175
|
|
|
$
|
3,789,841
|
|
|
$
|
3,962,222
|
|
|
$
|
3,529,221
|
|
Provision for income taxes
|
$
|
1,150,933
|
|
|
$
|
1,038,381
|
|
|
$
|
861,945
|
|
|
$
|
1,023,799
|
|
|
$
|
876,364
|
|
Net income attributable to Gilead
|
$
|
3,074,808
|
|
|
$
|
2,591,566
|
|
|
$
|
2,803,637
|
|
|
$
|
2,901,257
|
|
|
$
|
2,635,755
|
|
Net income per share attributable to Gilead common stockholders-basic
|
$
|
2.01
|
|
|
$
|
1.71
|
|
|
$
|
1.81
|
|
|
$
|
1.69
|
|
|
$
|
1.46
|
|
Shares used in per share calculation-basic
|
1,528,620
|
|
|
1,514,621
|
|
|
1,549,806
|
|
|
1,712,120
|
|
|
1,809,208
|
|
|||||
Net income per share attributable to Gilead common stockholders-diluted
|
$
|
1.81
|
|
|
$
|
1.64
|
|
|
$
|
1.77
|
|
|
$
|
1.66
|
|
|
$
|
1.41
|
|
Shares used in per share calculation-diluted
|
1,694,747
|
|
|
1,582,549
|
|
|
1,580,236
|
|
|
1,746,792
|
|
|
1,868,218
|
|
|
December 31,
|
||||||||||||||||||
|
2013
|
|
2012
|
|
2011
|
|
2010
|
|
2009
|
||||||||||
CONSOLIDATED BALANCE SHEET DATA:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash, cash equivalents and marketable securities
|
$
|
2,570,590
|
|
|
$
|
2,582,086
|
|
|
$
|
9,963,972
|
|
|
$
|
5,318,071
|
|
|
$
|
3,904,846
|
|
Working capital
(2)
|
$
|
948,332
|
|
|
$
|
1,918,450
|
|
|
$
|
11,431,584
|
|
|
$
|
3,271,267
|
|
|
$
|
2,963,066
|
|
Total assets
(3)
|
$
|
22,496,785
|
|
|
$
|
21,239,838
|
|
|
$
|
17,303,134
|
|
|
$
|
11,592,630
|
|
|
$
|
9,698,559
|
|
Other long-term obligations
(2)
|
$
|
156,647
|
|
|
$
|
249,973
|
|
|
$
|
175,325
|
|
|
$
|
55,536
|
|
|
$
|
58,057
|
|
Convertible senior notes, senior unsecured notes and credit facility
(4)
|
$
|
6,635,678
|
|
|
$
|
8,223,988
|
|
|
$
|
7,605,734
|
|
|
$
|
3,477,564
|
|
|
$
|
1,155,443
|
|
Retained earnings
|
$
|
6,105,244
|
|
|
$
|
3,704,744
|
|
|
$
|
1,776,760
|
|
|
$
|
1,183,730
|
|
|
$
|
1,995,272
|
|
Total stockholders' equity
(2)
|
$
|
11,744,501
|
|
|
$
|
9,543,722
|
|
|
$
|
6,867,349
|
|
|
$
|
6,121,837
|
|
|
$
|
6,505,158
|
|
(1)
|
|
During 2012, we recorded $100.1 million and $93.8 million of stock-based compensation in research and development (R&D) expenses and selling, general and administrative expenses, respectively, related to the acquisition of Pharmasset, Inc. (Pharmasset).
|
|
|
During 2011, we recorded $26.6 million of impairment charges in R&D expenses related to certain in-process research and development (IPR&D) assets acquired from CGI Pharmaceuticals, Inc.
|
|
|
During 2010, we recorded $136.0 million of impairment charges in R&D expenses related to certain IPR&D assets acquired from CV Therapeutics, Inc. (CV Therapeutics).
|
(2)
|
|
Certain prior period amounts have been reclassified to conform to the current presentation.
|
(3)
|
|
During 2012, we completed the acquisition of Pharmasset and we recognized consideration transferred of $11.05 billion which was primarily recorded in intangible assets. We financed the transaction with approximately $5.20 billion in cash on hand, $2.15 billion in bank debt issued in January 2012 and $3.70 billion in senior unsecured notes issued in December 2011.
|
|
|
During 2009, we completed the acquisition of CV Therapeutics and we recognized consideration transferred of $1.39 billion which was primarily recorded in intangible assets.
|
(4)
|
|
During 2013, we repaid $1.52 billion of principal balance of convertible senior notes and repaid $150.0 million under the five-year revolving credit facility credit agreement (the Five-Year Revolving Credit Agreement).
|
|
|
During 2012, we borrowed $750.0 million under our Five-Year Revolving Credit Agreement.
|
|
|
During 2011, we issued $4.70 billion principal amount of senior unsecured notes in registered offerings.
|
|
|
During 2010, we issued $2.50 billion principal amount of convertible senior notes in a private placement.
|
ITEM 7.
|
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
•
|
expanded our single tablet regimen (STR) products with the European launch of Stribild in 14 countries;
|
•
|
received U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval of Complera/Eviplera for use among certain adult patients switching from another stable antiretroviral regimen;
|
•
|
received EMA approval for once-daily Tybost, a pharmacokinetic enhancer that boosts blood levels of certain HIV medicines;
|
•
|
received EMA approval for Vitekta, an integrase inhibitor for the treatment of HIV-1 infection in adults without known mutations associated with resistance to elvitegravir;
|
•
|
advanced the clinical development of tenofovir alafenamide (TAF) as a once-daily single tablet regimen for the treatment of HIV-1 infection to Phase 3 clinical trials;
|
•
|
received approval from the FDA and Health Canada in December 2013 for Sovaldi (sofosbuvir), a once daily oral regimen for the treatment of HCV as a component of a combination of antiviral treatment regimens; received approval from the EMA for Sovaldi in January 2014;
|
•
|
announced positive interim results from three Phase 3 clinical studies (ION-1, ION-2 and ION-3) evaluating the once-daily fixed-dose combination of ledipasvir/sofosbuvir (LDV/SOF), with and without ribavirin (RBV), for the treatment of genotype 1 HCV infection; filed a new drug application (NDA) for the fixed-dose combination of LDV/SOF in February 2014;
|
•
|
submitted an NDA to the FDA for approval of idelalisib for the treatment of patients with indolent non-Hodgkin's lymphoma (iNHL) and chronic lymphocytic leukemia (CLL). We also filed for approval of idelalisib for treatment of iNHL and CLL with the EMA on October 28, 2013. In January 2014, the FDA accepted our NDA for iNHL and set a target review date of September 11, 2014 under the Prescription Drug User Fee Act (PDUFA). In February 2014, the FDA, which previously granted Breakthrough Therapy designation for idelalisib in CLL, accepted our NDA and set a target review date of August 6, 2014 under the PDUFA; and
|
•
|
completed the acquisition of YM Biosciences Inc. (YM), through which we acquired momelotinib, an orally administered, once-daily candidate for hematologic cancers and advanced the clinical development of momelotinib to Phase 3 clinical trials.
|
(In thousands, except percentages)
|
|
2013
|
|
Change
|
|
2012
|
|
Change
|
|
2011
|
||||||||
Antiviral products:
|
|
|
|
|
|
|
|
|
|
|
||||||||
Atripla
|
|
$
|
3,648,496
|
|
|
2
|
%
|
|
$
|
3,574,483
|
|
|
11
|
%
|
|
$
|
3,224,518
|
|
Truvada
|
|
3,135,771
|
|
|
(1
|
)%
|
|
3,181,110
|
|
|
11
|
%
|
|
2,875,141
|
|
|||
Viread
|
|
958,969
|
|
|
13
|
%
|
|
848,697
|
|
|
15
|
%
|
|
737,867
|
|
|||
Complera/Eviplera
|
|
809,452
|
|
|
137
|
%
|
|
342,200
|
|
|
783
|
%
|
|
38,747
|
|
|||
Stribild
|
|
539,256
|
|
|
837
|
%
|
|
57,536
|
|
|
—
|
%
|
|
—
|
|
|||
Sovaldi
|
|
139,435
|
|
|
—
|
%
|
|
—
|
|
|
—
|
%
|
|
—
|
|
|||
Hepsera
|
|
81,095
|
|
|
(25
|
)%
|
|
108,315
|
|
|
(25
|
)%
|
|
144,679
|
|
|||
Emtriva
|
|
27,405
|
|
|
(7
|
)%
|
|
29,449
|
|
|
2
|
%
|
|
28,764
|
|
|||
Total antiviral products
|
|
9,339,879
|
|
|
15
|
%
|
|
8,141,790
|
|
|
15
|
%
|
|
7,049,716
|
|
|||
Letairis
|
|
519,966
|
|
|
27
|
%
|
|
410,054
|
|
|
40
|
%
|
|
293,426
|
|
|||
Ranexa
|
|
448,624
|
|
|
20
|
%
|
|
372,949
|
|
|
17
|
%
|
|
320,004
|
|
|||
AmBisome
|
|
351,827
|
|
|
1
|
%
|
|
346,646
|
|
|
5
|
%
|
|
330,156
|
|
|||
Other products
|
|
143,399
|
|
|
13
|
%
|
|
126,932
|
|
|
16
|
%
|
|
109,057
|
|
|||
Total product sales
|
|
$
|
10,803,695
|
|
|
15
|
%
|
|
$
|
9,398,371
|
|
|
16
|
%
|
|
$
|
8,102,359
|
|
•
|
Atripla
|
•
|
Truvada
|
•
|
Complera/Eviplera
|
•
|
Stribild
|
•
|
Sovaldi
|
(In thousands, except percentages)
|
|
2013
|
|
Change
|
|
2012
|
|
Change
|
|
2011
|
||||||||
Royalty revenues
|
|
$
|
383,849
|
|
|
32
|
%
|
|
$
|
290,523
|
|
|
8
|
%
|
|
$
|
268,827
|
|
(In thousands, except percentages)
|
|
2013
|
|
Change
|
|
2012
|
|
Change
|
|
2011
|
||||||||
Total product sales
|
|
$
|
10,803,695
|
|
|
15
|
%
|
|
$
|
9,398,371
|
|
|
16
|
%
|
|
$
|
8,102,359
|
|
Cost of goods sold
|
|
$
|
2,858,502
|
|
|
16
|
%
|
|
$
|
2,471,363
|
|
|
16
|
%
|
|
$
|
2,124,410
|
|
Product gross margin
|
|
74
|
%
|
|
|
|
|
74
|
%
|
|
|
|
|
74
|
%
|
(In thousands, except percentages)
|
|
2013
|
|
Change
|
|
2012
|
|
Change
|
|
2011
|
||||||||
Research and development
|
|
$
|
2,119,756
|
|
|
20
|
%
|
|
$
|
1,759,945
|
|
|
43
|
%
|
|
$
|
1,229,151
|
|
(In thousands, except percentages)
|
|
2013
|
|
2012
|
|
2011
|
||||||
Clinical studies and outside services
|
|
$
|
1,147,169
|
|
|
$
|
828,278
|
|
|
$
|
570,302
|
|
Personnel and infrastructure expenses
|
|
714,027
|
|
|
686,091
|
|
|
412,463
|
|
|||
Facilities, IT and other costs
|
|
258,560
|
|
|
245,576
|
|
|
219,756
|
|
|||
In-process research and development impairment charges
|
|
—
|
|
|
—
|
|
|
26,630
|
|
|||
Total
|
|
$
|
2,119,756
|
|
|
$
|
1,759,945
|
|
|
$
|
1,229,151
|
|
(In thousands, except percentages)
|
|
2013
|
|
Change
|
|
2012
|
|
Change
|
|
2011
|
||||||||
Selling, general and administrative
|
|
$
|
1,699,431
|
|
|
16
|
%
|
|
$
|
1,461,034
|
|
|
18
|
%
|
|
$
|
1,241,983
|
|
Total consideration transferred
|
$
|
10,858,372
|
|
Stock-based compensation expense
|
193,937
|
|
|
Total cash paid
|
$
|
11,052,309
|
|
Identifiable intangible assets
|
$
|
10,738,000
|
|
Cash and cash equivalents
|
106,737
|
|
|
Other assets acquired (liabilities assumed), net
|
(43,182
|
)
|
|
Total identifiable net assets
|
10,801,555
|
|
|
Goodwill
|
56,817
|
|
|
Total consideration transferred
|
$
|
10,858,372
|
|
|
|
Year Ended
|
||
|
|
December 31, 2012
|
||
Research and development expense
|
|
$
|
100,149
|
|
Selling, general and administrative expense
|
|
93,788
|
|
|
Total stock-based compensation expense
|
|
$
|
193,937
|
|
|
|
Year Ended December 31,
|
||||||
|
|
2012
|
|
2011
|
||||
Transaction costs (e.g. investment advisory, legal and accounting fees)
|
|
$
|
10,635
|
|
|
$
|
28,461
|
|
Bridge financing costs
|
|
7,333
|
|
|
23,817
|
|
||
Restructuring costs
|
|
15,125
|
|
|
—
|
|
||
Total other costs
|
|
$
|
33,093
|
|
|
$
|
52,278
|
|
|
|
Year Ended December 31,
|
||||||
|
|
2012
|
|
2011
|
||||
Research and development expense
|
|
$
|
7,906
|
|
|
$
|
—
|
|
Selling, general and administrative expense
|
|
17,854
|
|
|
28,461
|
|
||
Interest expense
|
|
7,333
|
|
|
23,817
|
|
||
Total other costs
|
|
$
|
33,093
|
|
|
$
|
52,278
|
|
(In thousands)
|
|
2013
|
|
2012
|
|
2011
|
|||||||
As of December 31:
|
|
|
|
|
|
|
|||||||
Cash, cash equivalents and marketable securities
|
|
$
|
2,570,590
|
|
|
$
|
2,582,086
|
|
|
$
|
9,963,972
|
|
|
Working capital
(1)
|
|
$
|
948,332
|
|
|
$
|
1,918,450
|
|
|
$
|
11,431,584
|
|
|
Year Ended December 31:
|
|
|
|
|
|
|
|
|
|
||||
Cash provided by (used in):
|
|
|
|
|
|
|
|
|
|
||||
Operating activities
|
|
$
|
3,104,988
|
|
|
$
|
3,194,716
|
|
|
$
|
3,639,010
|
|
|
Investing activities
|
|
$
|
(254,355
|
)
|
|
$
|
(11,846,054
|
)
|
|
$
|
3,589,845
|
|
|
Financing activities
|
|
$
|
(2,543,941
|
)
|
|
$
|
563,346
|
|
|
$
|
1,763,569
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Certain prior period amounts have been reclassified to conform to the current presentation.
|
|
|
|
|
|
|
|
|
Interest
|
|
December 31,
|
||||||
Type of Borrowing
|
|
Description
|
|
Issue Date
|
|
Due Date
|
|
Rate
|
|
2013
|
|
2012
|
||||
Convertible Senior
|
|
May 2013 Notes
|
|
April 2006
|
|
May 2013
|
|
0.625%
|
|
$
|
—
|
|
|
$
|
419,433
|
|
Convertible Senior
|
|
May 2014 Notes
|
|
July 2010
|
|
May 2014
|
|
1.00%
|
|
234,217
|
|
|
1,210,213
|
|
||
Convertible Senior
|
|
May 2016 Notes
|
|
July 2010
|
|
May 2016
|
|
1.625%
|
|
1,113,043
|
|
|
1,157,692
|
|
||
Senior Unsecured
|
|
April 2021 Notes
|
|
March 2011
|
|
April 2021
|
|
4.50%
|
|
993,781
|
|
|
992,923
|
|
||
Senior Unsecured
|
|
December 2014 Notes
|
|
December 2011
|
|
December 2014
|
|
2.40%
|
|
749,710
|
|
|
749,394
|
|
||
Senior Unsecured
|
|
December 2016 Notes
|
|
December 2011
|
|
December 2016
|
|
3.05%
|
|
699,326
|
|
|
699,095
|
|
||
Senior Unsecured
|
|
December 2021 Notes
|
|
December 2011
|
|
December 2021
|
|
4.40%
|
|
1,247,716
|
|
|
1,247,428
|
|
||
Senior Unsecured
|
|
December 2041 Notes
|
|
December 2011
|
|
December 2041
|
|
5.65%
|
|
997,885
|
|
|
997,810
|
|
||
Credit Facility
|
|
Five-Year Revolver
|
|
January 2012
|
|
January 2017
|
|
Variable
|
|
600,000
|
|
|
750,000
|
|
||
Total debt, net
|
|
6,635,678
|
|
|
8,223,988
|
|
||||||||||
Less current portion
|
|
2,696,970
|
|
|
1,169,433
|
|
||||||||||
Total long-term debt, net
|
|
$
|
3,938,708
|
|
|
$
|
7,054,555
|
|
•
|
the commercial performance of our current and future products;
|
•
|
the progress and scope of our R&D efforts, including preclinical studies and clinical trials;
|
•
|
the cost, timing and outcome of regulatory reviews;
|
•
|
the expansion of our sales and marketing capabilities;
|
•
|
administrative expenses;
|
•
|
the possibility of acquiring additional manufacturing capabilities or office facilities;
|
•
|
the possibility of acquiring other companies or new products;
|
•
|
costs associated with the settlement and conversion of our convertible senior notes and related warrants;
|
•
|
the establishment of additional collaborative relationships with other companies; and
|
•
|
costs associated with the defense, settlement and adverse results of litigation and government investigations.
|
Accrued government rebates and allowance for government chargebacks:
|
|
Balance at
Beginning
of Year
|
|
Reduction/(Increase) to Product Sales
|
|
Deducted
from
Accruals
|
|
Balance at
End of
Year
|
||||||||
Year ended December 31, 2013:
|
|
|
|
|
|
|
|
|
||||||||
Activity related to 2013 sales
|
|
$
|
—
|
|
|
$
|
3,197,052
|
|
|
$
|
2,182,454
|
|
|
$
|
1,014,598
|
|
Activity related to sales prior to 2013
|
|
827,691
|
|
|
(114,048
|
)
|
|
619,782
|
|
|
93,861
|
|
||||
Total
|
|
$
|
827,691
|
|
|
$
|
3,083,004
|
|
|
$
|
2,802,236
|
|
|
$
|
1,108,459
|
|
Year ended December 31, 2012:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Activity related to 2012 sales
|
|
$
|
—
|
|
|
$
|
2,580,317
|
|
|
$
|
1,836,199
|
|
|
$
|
744,118
|
|
Activity related to sales prior to 2012
|
|
597,693
|
|
|
10,511
|
|
|
524,631
|
|
|
83,573
|
|
||||
Total
|
|
$
|
597,693
|
|
|
$
|
2,590,828
|
|
|
$
|
2,360,830
|
|
|
$
|
827,691
|
|
•
|
estimates of revenues and operating profits related to the products or product candidates;
|
•
|
the probability of success for unapproved product candidates considering their stages of development;
|
•
|
the time and resources needed to complete the development and approval of product candidates;
|
•
|
the life of the potential commercialized products and associated risks, including the inherent difficulties and uncertainties in developing a product candidate such as obtaining FDA and other regulatory approvals; and
|
•
|
risks related to the viability of and potential alternative treatments in any future target markets.
|
•
|
estimates of revenues and operating profits related to the products or product candidates;
|
•
|
the probability of success for unapproved product candidates considering their stages of development;
|
•
|
the time and resources needed to complete the development and approval of product candidates;
|
•
|
the life of the potential commercialized products and associated risks, including the inherent difficulties and uncertainties in developing a product candidate such as obtaining FDA and other regulatory approvals; and
|
•
|
risks related to the viability of and potential alternative treatments in any future target markets.
|
|
|
|
Payments due by Period
|
||||||||||||||||||
Contractual Obligations
|
|
|
Total
|
|
Less than one
year
|
|
1-3 years
|
|
3-5 years
|
|
More than 5
years
|
||||||||||
Debt
(1)
|
|
$
|
9,201,555
|
|
|
$
|
3,005,855
|
|
|
$
|
1,055,700
|
|
|
$
|
313,000
|
|
|
$
|
4,827,000
|
|
|
Operating lease obligations
|
|
226,313
|
|
|
48,976
|
|
|
87,729
|
|
|
57,686
|
|
|
31,922
|
|
||||||
Capital commitments
(2)
|
|
42,538
|
|
|
42,538
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Purchase obligations
(3)(4)
|
|
1,990,598
|
|
|
1,588,544
|
|
|
324,974
|
|
|
77,080
|
|
|
—
|
|
||||||
Clinical trials
(5)
|
|
429,365
|
|
|
218,915
|
|
|
150,496
|
|
|
49,705
|
|
|
10,249
|
|
||||||
Total
|
|
$
|
11,890,369
|
|
|
$
|
4,904,828
|
|
|
$
|
1,618,899
|
|
|
$
|
497,471
|
|
|
$
|
4,869,171
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Our debt obligations include convertible senior notes, senior unsecured notes and Five-Year Revolving Credit Agreement. We incur future interest payments based on fixed rates of 1.00% and 1.625% for May 2014 Notes and May 2016 Notes, respectively and 2.40%, 3.05%, 4.50%, 4.40% and 5.65% for our senior unsecured notes due in December 2014, December 2016, April 2021, December 2021 and December 2041, respectively. The Five-Year Revolving Credit Agreement incurs interest based on variable interest rates. During
2013
, the portion of interest expense related to variable interest totaled
$7.8 million
.
|
(2)
|
At
December 31, 2013
, we had firm capital project commitments of approximately
$42.5 million
primarily relating to facilities improvement projects.
|
(3)
|
At
December 31, 2013
, we had firm purchase commitments related to active pharmaceutical ingredients and certain inventory-related items. These amounts include minimum purchase requirements and actual purchases are expected to significantly exceed these amounts.
|
(4)
|
In addition to the above, we have committed to make potential future milestone payments to third parties as part of licensing, collaboration and development arrangements. Payments under these agreements generally become due and payable only upon achievement of certain developmental, regulatory and/or commercial milestones. Because the achievement of these milestones is neither probable nor reasonably estimable, such contingencies have not been recorded on our Consolidated Balance Sheets and have not been included in the table above.
|
(5)
|
At
December 31, 2013
, we had several clinical studies in various clinical trial phases. Our most significant clinical trial expenditures are to CROs. Although all of our material contracts with CROs are cancelable, we historically have not canceled such contracts. These amounts reflect commitments based on existing contracts and do not reflect any future modifications to, or terminations of, existing contracts or anticipated or potential new contracts.
|
ITEM 7A.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
•
|
safety and preservation of principal and diversification of risk;
|
•
|
liquidity of investments sufficient to meet cash flow requirements; and
|
•
|
competitive after-tax rate of return.
|
|
|
Expected Maturity
|
|
|
|
|
|
Total Fair Value at December 31, 2013
|
||||||||||||||||||||||||
|
|
2014
|
|
2015
|
|
2016
|
|
2017
|
|
2018
|
|
Thereafter
|
|
Total
|
|
|||||||||||||||||
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Available-for-sale debt securities
|
|
$
|
18,756
|
|
|
$
|
255,176
|
|
|
$
|
157,450
|
|
|
$
|
7,130
|
|
|
$
|
13,759
|
|
|
$
|
5,513
|
|
|
$
|
457,784
|
|
|
$
|
457,784
|
|
Average interest rate
|
|
0.4
|
%
|
|
0.4
|
%
|
|
0.7
|
%
|
|
0.6
|
%
|
|
0.9
|
%
|
|
2.8
|
%
|
|
|
|
|
|
|
||||||||
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Debt
(1)
|
|
$
|
2,161,091
|
|
|
$
|
—
|
|
|
$
|
700,000
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,250,000
|
|
|
$
|
6,111,091
|
|
|
$
|
9,689,387
|
|
Average interest rate
|
|
1.8
|
%
|
|
—
|
%
|
|
3.1
|
%
|
|
—
|
%
|
|
—
|
%
|
|
4.8
|
%
|
|
|
|
|
|
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
In December 2011, we issued senior unsecured notes due in December 2014, 2016, 2021 and 2041 in a registered offering. The notes pay interest at fixed annual rates ranging from 2.40% to 5.65%. In March 2011, we issued senior unsecured notes due in April 2021 in a registered offering. The notes pay interest at a fixed annual rate of 4.50%.
|
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
|
ITEM 10.
|
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
|
ITEM 11.
|
EXECUTIVE COMPENSATION
|
ITEM 12.
|
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
|
ITEM 13.
|
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
|
ITEM 14.
|
PRINCIPAL ACCOUNTANT FEES AND SERVICES
|
Audited Consolidated Financial Statements
|
|
ITEM 15.
|
EXHIBITS
|
Exhibit
Footnote
|
|
Exhibit Number
|
|
Description of Document
|
√(1)
|
2.1
|
|
Agreement and Plan of Merger among Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc., dated as of March 12, 2009
|
|
|
|
|
|
|
†(2)
|
2.2
|
|
Agreement and Plan of Merger among Registrant, Merger Sub and Pharmasset, Inc., dated as of November 21, 2011
|
|
|
|
|
|
|
(3)
|
2.3
|
|
Arrangement Agreement among Registrant, 3268218 Nova Scotia Limited and YM Biosciences Inc., dated as of December 12, 2012
|
|
|
|
|
|
|
*(4)
|
3.1
|
|
Restated Certificate of Incorporation of Registrant
|
|
|
|
|
|
|
*(5)
|
3.2
|
|
Amendment to Certificate of Incorporation of Registrant
|
|
|
|
|
|
|
*(4)
|
3.3
|
|
Amended and Restated Bylaws of Registrant, as amended and restated on May 12, 2011
|
|
|
|
|
|
|
|
4.1
|
|
Reference is made to Exhibit 3.1 and Exhibit 3.2
|
|
|
|
|
|
|
*(6)
|
4.2
|
|
Indenture related to the Convertible Senior Notes due 2013 (2013 Notes), between Registrant and Wells Fargo Bank, National Association, as trustee (including form of 0.625% Convertible Senior Note due 2013), dated April 25, 2006
|
|
|
|
|
|
|
*(7)
|
4.3
|
|
Indenture related to the Convertible Senior Notes due 2014 (2014 Notes), between Registrant and Wells Fargo Bank, National Association, as trustee (including form of 1.00% Convertible Senior Note due 2014), dated July 30, 2010
|
|
|
|
|
|
|
*(7)
|
4.4
|
|
Indenture related to the Convertible Senior Notes due 2016 (2016 Notes), between Registrant and Wells Fargo Bank, National Association, as trustee (including form of 1.625% Convertible Senior Note due 2016), dated July 30, 2010
|
|
|
|
|
|
|
*(8)
|
4.5
|
|
Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee
|
|
|
|
|
|
|
*(8)
|
4.6
|
|
First Supplemental Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including form of Senior Notes)
|
|
|
|
|
|
*(9)
|
4.7
|
|
Second Supplemental Indenture related to Senior Notes, dated as of December 13, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including Form of 2014 Note, Form of 2016 Note, Form of 2021 Note, Form of 2041 Note)
|
|
|
|
|
|
|
*(10)
|
10.1
|
|
Confirmation of OTC Convertible Note Hedge related to 2013 Notes, dated April 19, 2006, as amended and restated as of April 24, 2006, between Registrant and Bank of America, N.A.
|
|
|
|
|
|
|
*(10)
|
10.2
|
|
Confirmation of OTC Warrant Transaction, dated April 19, 2006, as amended and restated as of April 24, 2006, between Registrant and Bank of America, N.A. for warrants expiring in 2013
|
|
|
|
|
|
|
*(11)
|
10.3
|
|
Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated July 26, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(11)
|
10.4
|
|
Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(11)
|
10.5
|
|
Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated July 26, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(11)
|
10.6
|
|
Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(11)
|
10.7
|
|
Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2014
|
|
|
|
|
|
|
*(11)
|
10.8
|
|
Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2014
|
|
|
|
|
|
|
*(11)
|
10.9
|
|
Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2016
|
|
|
|
|
|
|
*(11)
|
10.10
|
|
Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2016
|
|
|
|
|
|
|
*(12)
|
10.11
|
|
Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 5, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(12)
|
10.12
|
|
Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(12)
|
10.13
|
|
Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 5, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(12)
|
10.14
|
|
Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(12)
|
10.15
|
|
Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2014
|
|
|
|
|
|
|
*(12)
|
10.16
|
|
Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2014
|
|
|
|
|
|
|
*(12)
|
10.17
|
|
Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2016
|
|
|
|
|
|
|
*(12)
|
10.18
|
|
Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2016
|
|
|
|
|
|
|
*(12)
|
10.19
|
|
Amendment to Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(12)
|
10.20
|
|
Amendment to Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(12)
|
10.21
|
|
Amendment to Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
*(12)
|
10.22
|
|
Amendment to Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(12)
|
10.23
|
|
Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(12)
|
10.24
|
|
Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(12)
|
10.25
|
|
Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(12)
|
10.26
|
|
Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(13)
|
10.27
|
|
5-Year Revolving Credit Facility Credit Agreement among Registrant and Gilead Biopharmaceutics Ireland Corporation, as Borrowers, Bank of America, N.A., as Administrative Agent, Swing Line Lender and L/C Issuer, certain other lenders parties thereto, Barclays Capital, as Syndication Agent, and Goldman Sachs Bank USA, JPMorgan Chase Bank, N.A., Royal Bank of Canada and Wells Fargo Bank, N.A., as Co-Documentation Agents, dated as of January 12, 2012
|
|
|
|
|
|
|
*(13)
|
10.28
|
|
Parent Guaranty Agreement (5-Year Revolving Credit Facility), dated as of January 12, 2012, by Registrant
|
|
|
|
|
|
|
*(4)
|
10.29
|
|
Gilead Sciences, Inc. 2004 Equity Incentive Plan, as amended through May 8, 2013
|
|
|
|
|
|
|
*(14)
|
10.30
|
|
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants prior to February 2008)
|
|
|
|
|
|
|
*(15)
|
10.31
|
|
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants made February 2008 through April 2009)
|
|
|
|
|
|
|
*(16)
|
10.32
|
|
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants commencing in May 2009)
|
|
|
|
|
|
|
*(17)
|
10.33
|
|
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants commencing in February 2010)
|
|
|
|
|
|
|
*(18)
|
10.34
|
|
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for 2011 and subsequent year grants)
|
|
|
|
|
|
|
*(15)
|
10.35
|
|
Form of non-employee director stock option agreement used under 2004 Equity Incentive Plan (for grants prior to 2008)
|
|
|
|
|
|
|
*(15)
|
10.36
|
|
Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for initial grants made in 2008)
|
|
|
|
|
|
|
*(15)
|
10.37
|
|
Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for annual grants made in May 2008 and through May 2012)
|
|
|
|
|
|
|
*(16)
|
10.38
|
|
Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for annual grants commencing in May 2009 and through May 2012)
|
|
|
|
|
|
|
*(19)
|
10.39
|
|
Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for annual grants made in May 2013)
|
|
|
|
|
|
|
*(19)
|
10.40
|
|
Form of non-employee director option agreement (non-U.S.) used under 2004 Equity Incentive Plan (for annual grants made in May 2013)
|
|
|
|
|
|
|
*(20)
|
10.41
|
|
Form of restricted stock unit issuance agreement used under 2004 Equity Incentive Plan (for annual grants to non-employee directors in May 2012)
|
|
|
|
|
|
|
*(16)
|
10.42
|
|
Form of restricted stock award agreement used under 2004 Equity Incentive Plan (for annual grants to certain non-employee directors prior to May 2012)
|
|
|
|
|
|
*(19)
|
10.43
|
|
Form of restricted stock unit issuance agreement used under 2004 Equity Incentive Plan (for annual grants to non-employee directors commencing in May 2013)
|
|
|
|
|
|
|
*(19)
|
10.44
|
|
Form of restricted stock unit issuance agreement (non-U.S.) used under 2004 Equity Incentive Plan (for annual grants to non-employee directors commencing in May 2013)
|
|
|
|
|
|
|
*(16)
|
10.45
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2009)
|
|
*(17)
|
10.46
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2010)
|
|
|
|
|
|
|
*(18)
|
10.47
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2011)
|
|
|
|
|
|
|
*(21)
|
10.48
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2012)
|
|
|
|
|
|
|
*(22)
|
10.49
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for TSR Goals in 2013)
|
|
|
|
|
|
|
*(22)
|
10.50
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for Revenue Goals in 2013)
|
|
|
|
|
|
|
*(23)
|
10.51
|
|
Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made prior to May 2009)
|
|
|
|
|
|
|
*(16)
|
10.52
|
|
Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers commencing in May 2009)
|
|
|
|
|
|
|
*(24)
|
10.53
|
|
Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (service-based vesting for certain executive officers commencing in November 2009)
|
|
|
|
|
|
|
*(18)
|
10.54
|
|
Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (service-based vesting for certain executive officers commencing in 2011)
|
|
|
|
|
|
|
*(19)
|
10.55
|
|
Gilead Sciences, Inc. Employee Stock Purchase Plan, amended and restated through May 8, 2013
|
|
|
|
|
|
|
*(19)
|
10.56
|
|
Gilead Sciences, Inc. International Employee Stock Purchase Plan, amended and restated through May 8, 2013
|
|
|
|
|
|
|
*(25)
|
10.57
|
|
Gilead Sciences, Inc. Deferred Compensation Plan-Basic Plan Document
|
|
|
|
|
|
|
*(25)
|
10.58
|
|
Gilead Sciences, Inc. Deferred Compensation Plan-Adoption Agreement
|
|
|
|
|
|
|
*(25)
|
10.59
|
|
Addendum to the Gilead Sciences, Inc. Deferred Compensation Plan
|
|
|
|
|
|
|
*(26)
|
10.60
|
|
Gilead Sciences, Inc. 2005 Deferred Compensation Plan, as amended and restated on October 23, 2008
|
|
|
|
|
|
|
*(21)
|
10.61
|
|
Gilead Sciences, Inc. Severance Plan, as amended on January 26, 2012
|
|
|
|
|
|
|
*(14)
|
10.62
|
|
Gilead Sciences, Inc. Corporate Bonus Plan
|
|
|
|
|
|
|
*(4)
|
10.63
|
|
Amended and Restated Gilead Sciences, Inc. Code Section 162(m) Bonus Plan
|
|
|
|
|
|
|
*(27)
|
10.64
|
|
2013 Base Salaries for the Named Executive Officers
|
|
|
|
|
|
|
*(28)
|
10.65
|
|
Offer Letter dated April 16, 2008 between Registrant and Robin Washington
|
|
|
|
|
|
|
*(29)
|
10.66
|
|
Form of Indemnity Agreement entered into between Registrant and its directors and executive officers
|
|
|
|
|
|
|
*(29)
|
10.67
|
|
Form of Employee Proprietary Information and Invention Agreement entered into between Registrant and certain of its officers and key employees
|
|
|
|
|
|
*(17)
|
10.68
|
|
Form of Employee Proprietary Information and Invention Agreement entered into between Registrant and certain of its officers and key employees (revised in September 2006)
|
|
|
|
|
|
|
(30)
|
10.69
|
|
Amended and Restated Collaboration Agreement by and among Registrant, Gilead Holdings, LLC, Bristol-Myers Squibb Company, E.R. Squibb & Sons, L.L.C., and Bristol-Myers Squibb & Gilead Sciences, LLC, dated September 28, 2006
|
|
|
|
|
|
|
(15)
|
10.70
|
|
Commercialization Agreement by and between Gilead Sciences Limited and Bristol-Myers Squibb Company, dated December 10, 2007
|
|
|
|
|
|
|
(31)
|
10.71
|
|
Amendment Agreement, dated October 25, 1993, between Registrant, the Institute of Organic Chemistry and Biochemistry (IOCB) and Rega Stichting v.z.w. (REGA), together with the following exhibits: the License Agreement, dated December 15, 1991, between Registrant, IOCB and REGA (the 1991 License Agreement), the License Agreement, dated October 15, 1992, between Registrant, IOCB and REGA (the October 1992 License Agreement) and the License Agreement, dated December 1, 1992, between Registrant, IOCB and REGA (the December 1992 License Agreement)
|
|
|
|
|
|
|
(32)
|
10.72
|
|
Amendment Agreement between Registrant and IOCB/REGA, dated December 27, 2000 amending the 1991 License Agreement and the December 1992 License Agreement
|
|
|
|
|
|
|
(30)
|
10.73
|
|
Sixth Amendment Agreement to the License Agreement, between IOCB/REGA and Registrant, dated August 18, 2006 amending the October 1992 License Agreement and the December 1992 License Agreement
|
|
|
|
|
|
|
+(33)
|
10.74
|
|
Seventh Amendment Agreement to the License Agreement, between IOCB/REGA and Registrant dated July 1, 2013 amending the October 1992 License Agreement and the December 1992 License Agreement
|
|
|
|
|
|
|
(30)
|
10.75
|
|
Development and License Agreement among Registrant and F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc., dated September 27, 1996
|
|
|
|
|
|
|
(34)
|
10.76
|
|
First Amendment and Supplement dated November 15, 2005 to the Development and Licensing Agreement between Registrant, F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. dated September 27, 1996
|
|
|
|
|
|
|
(35)
|
10.77
|
|
Second Amendment dated December 22, 2011 to the Development and Licensing Agreement between Registrant, F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. dated September 27, 1996
|
|
|
|
|
|
|
+(36)
|
10.78
|
|
Third Amendment dated October 5, 2012 to the Development and Licensing Agreement between Registrant, F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. dated September 27, 1996
|
|
|
|
|
|
|
(37)
|
10.79
|
|
Exclusive License Agreement between Registrant (as successor to Triangle Pharmaceuticals, Inc.), Glaxo Group Limited, The Wellcome Foundation Limited, Glaxo Wellcome Inc. and Emory University, dated May 6, 1999
|
|
|
|
|
|
|
(38)
|
10.80
|
|
Royalty Sale Agreement by and among Registrant, Emory University and Investors Trust & Custodial Services (Ireland) Limited, solely in its capacity as Trustee of Royalty Pharma, dated July 18, 2005
|
|
|
|
|
|
|
(38)
|
10.81
|
|
Amended and Restated License Agreement between Registrant, Emory University and Investors Trust & Custodial Services (Ireland) Limited, solely in its capacity as Trustee of Royalty Pharma, dated July 21, 2005
|
|
|
|
|
|
|
(39)
|
10.82
|
|
License Agreement between Japan Tobacco Inc. and Registrant, dated March 22, 2005
|
|
|
|
|
|
|
(40)
|
10.83
|
|
First Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated May 19, 2005
|
|
|
|
|
|
|
(40)
|
10.84
|
|
Second Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated May 17, 2010
|
|
|
|
|
|
|
(40)
|
10.85
|
|
Third Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated July 5, 2011
|
|
|
|
|
|
(40)
|
10.86
|
|
Fourth Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated July 5, 2011
|
|
|
|
|
|
|
+
|
10.87
|
|
Fifth Amendment to License Agreement between Japan Tobacco Inc. and Registrant dated October 10, 2013
|
|
|
|
|
|
|
(41)
|
10.88
|
|
License Agreement between Registrant (as successor to Myogen, Inc.) and Abbott Deutschland Holding GmbH dated October 8, 2001
|
|
|
|
|
|
|
+(42)
|
10.89
|
|
License Agreement between Registrant (as successor to Myogen, Inc.) and Glaxo Group Limited, dated March 3, 2006
|
|
|
|
|
|
|
(41)
|
10.90
|
|
License Agreement between Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated March 27, 1996
|
|
|
|
|
|
|
(43)
|
10.91
|
|
First Amendment to License Agreement between Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated July 3, 1997
|
|
|
|
|
|
|
(43)
|
10.92
|
|
Amendment No. 2 to License Agreement between Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated November 30, 1999
|
|
|
|
|
|
|
(44)
|
10.93
|
|
Amendment No. 4 to License Agreement with Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated June 20, 2006
|
|
|
|
|
|
|
(35)
|
10.94
|
|
Amendment No. 5 to License Agreement with Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated December 22, 2011
|
|
|
|
|
|
|
(45)
|
10.95
|
|
License and Collaboration Agreement by and among Registrant, Gilead Sciences Limited and Janssen R&D Ireland (formerly Tibotec Pharmaceuticals), dated July 16, 2009
|
|
|
|
|
|
|
(40)
|
10.96
|
|
Second Amendment to License and Collaboration Agreement by and among Registrant, Gilead Sciences Limited and Janssen R&D Ireland (formerly Tibotec Pharmaceuticals), dated July 1, 2011
|
|
|
|
|
|
|
+(22)
|
10.97
|
|
Amended and Restated Second Amendment to License and Collaboration Agreement by and among Registrant, Gilead Sciences Limited and Janssen R&D Ireland (formerly Tibotec Pharmaceuticals), dated February 7, 2013
|
|
|
|
|
|
|
(46)
|
10.98
|
|
Master Clinical and Commercial Supply Agreement between Gilead World Markets, Limited, Registrant and Patheon Inc., dated January 1, 2003
|
|
|
|
|
|
|
(34)
|
10.99
|
|
Restated and Amended Toll Manufacturing Agreement between Gilead Sciences Limited, Registrant and Takeda GmbH (formerly Nycomed GmbH and Altana Pharma Oranienburg GmbH), dated November 7, 2005
|
|
|
|
|
|
|
+(10)
|
10.100
|
|
Emtricitabine Manufacturing Supply Agreement between Gilead Sciences Limited and Evonik Degussa GmbH (formerly known as Degussa AG), dated June 6, 2006
|
|
|
|
|
|
|
+(11)
|
10.101
|
|
Amendment No. 1 to Emtricitabine Manufacturing Supply Agreement between Gilead Sciences Limited and Evonik Degussa GmbH (formerly known as Degussa AG), dated April 30, 2010
|
|
|
|
|
|
|
(47)
|
10.102
|
|
Purchase and Sale Agreement and Joint Escrow Instructions between Electronics for Imaging, Inc. and Registrant, dated July 18, 2012
|
|
|
|
|
|
|
(48)
|
10.103
|
|
Amendment No. 1, dated October 30, 2012, to the Purchase and Sale Agreement and Joint Escrow Instructions between Electronics for Imaging, Inc. and Registrant, dated July 18, 2012
|
|
|
|
|
|
|
|
21.1
|
|
Subsidiaries of Registrant
|
|
|
|
|
|
|
|
23.1
|
|
Consent of Independent Registered Public Accounting Firm
|
|
|
|
|
|
|
|
|
|
Power of Attorney, reference is made to the signature page
|
|
|
|
|
|
|
31.1
|
|
Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended
|
|
|
|
|
|
|
|
31.2
|
|
Certification of Chief Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended
|
|
|
|
|
|
|
|
32.1**
|
|
Certifications of Chief Executive Officer and Chief Financial Officer, as required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350)
|
|
|
|
|
|
|
|
101***
|
|
The following materials from Registrant's Annual Report on Form 10-K for the year ended December 31, 2013, formatted in Extensible Business Reporting Language (XBRL) includes: (i) Consolidated Balance Sheets at December 31, 2013 and 2012, (ii) Consolidated Statements of Income for the years ended December 31, 2013, 2012 and 2011, (iii) Consolidated Statements of Comprehensive Income for the years ended December 31, 2013, 2012 and 2011, (iv) Consolidated Statements of Stockholders' Equity for the years ended December 31, 2013, 2012 and 2011 (v) Consolidated Statements of Cash Flows for years ended December 31, 2013, 2012 and 2011, and (vi) Notes to Consolidated Financial Statements.
|
(1)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on March 12, 2009, and incorporated herein by reference.
|
(2)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on November 25, 2011, and incorporated herein by reference.
|
(3)
|
Filed as an exhibit to YM BioSciences Inc.'s Report on Form 6-K filed on December 12, 2012, and incorporated herein by reference.
|
(4)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on May 17, 2011, and incorporated herein by reference.
|
(5)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on May 13, 2013, and incorporated herein by reference.
|
(6)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on April 25, 2006, and incorporated herein by reference.
|
(7)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on August 2, 2010, and incorporated herein by reference.
|
(8)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on April 1, 2011, and incorporated herein by reference.
|
(9)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on December 13, 2011, and incorporated herein by reference.
|
(10)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, and incorporated herein by reference.
|
(11)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2010, and incorporated herein by reference.
|
(12)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2010, and incorporated herein by reference.
|
(13)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on January 17, 2012, and incorporated herein by reference.
|
(14)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K/A filed on February 22, 2006, and incorporated herein by reference.
|
(15)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2007, and incorporated herein by reference.
|
(16)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, and incorporated herein by reference.
|
(17)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2009, and incorporated herein by reference.
|
(18)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2011, and incorporated herein by reference.
|
(19)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, and incorporated herein by reference
|
(20)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2012, and incorporated herein by reference.
|
(21)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, and incorporated herein by reference.
|
(22)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2013, and incorporated herein by reference.
|
(23)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K first filed on December 19, 2007, and incorporated herein by reference.
|
(24)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2010, and incorporated herein by reference.
|
(25)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2001, and incorporated herein by reference.
|
(26)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2008, and incorporated herein by reference.
|
(27)
|
Information is included in Registrant's Current Report on Form 8-K filed on February 5, 2013, and incorporated herein by reference.
|
(28)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, and incorporated herein by reference.
|
(29)
|
Filed as an exhibit to Registrant's Registration Statement on Form S-1 (No. 33-55680), as amended, and incorporated herein by reference.
|
(30)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2006, and incorporated herein by reference.
|
(31)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended March 31, 1994, and incorporated herein by reference.
|
(32)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2000, and incorporated herein by reference.
|
(33)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, and incorporated herein by reference.
|
(34)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2005, and incorporated herein by reference.
|
(35)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and incorporated herein by reference.
|
(36)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2012, and incorporated herein by reference.
|
(37)
|
Filed as an exhibit to Triangle Pharmaceuticals, Inc.'s Quarterly Report on Form 10-Q/A filed on November 3, 1999, and incorporated herein by reference.
|
(38)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2005, and incorporated herein by reference.
|
(39)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2005, and incorporated herein by reference.
|
(40)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2011, and incorporated herein by reference.
|
(41)
|
Filed as an exhibit to Myogen, Inc.'s Registration Statement on Form S-1 (No. 333-108301), as amended, originally filed on August 28, 2003, and incorporated herein by reference.
|
(42)
|
Filed as an exhibit to Myogen, Inc.'s Quarterly Report on Form 10-Q filed on May 9, 2006, and incorporated herein by reference.
|
(43)
|
Filed as an exhibit to CV Therapeutics, Inc.'s Registration Statement on Form S-3 (No. 333-59318), as amended, originally filed on April 20, 2001, and incorporated herein by reference.
|
(44)
|
Filed as an exhibit to CV Therapeutics, Inc.'s Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, and incorporated herein by reference.
|
(45)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2009, and incorporated herein by reference.
|
(46)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2003, and incorporated herein by reference.
|
(47)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, and incorporated herein by reference.
|
(48)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2012, and incorporated herein by reference.
|
√
|
The Agreement and Plan of Merger (the Merger Agreement) contains representations and warranties of Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc. made solely to each other as of specific dates. Those representations and warranties were made solely for purposes of the Merger Agreement and may be subject to important qualifications and limitations agreed to by Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc. Moreover, some of those representations and warranties may not be accurate or complete as of any specified date, may be subject to a standard of materiality provided for in the Merger Agreement and have been used for the purpose of allocating risk among Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc. rather than establishing matters as facts.
|
†
|
The Agreement and Plan of Merger (the Pharmasset Merger Agreement) contains representations and warranties of Registrant, Merger Sub and Pharmasset, Inc. made solely to each other as of specific dates. Those representations and warranties were made solely for purposes of the Pharmasset Merger Agreement and may be subject to important qualifications and limitations agreed to by Registrant, Merger Sub and Pharmasset, Inc. Moreover, some of those representations and warranties may not be accurate or complete as of any specified date, may be subject to a standard of materiality provided for in the Pharmasset Merger Agreement and have been used for the purpose of allocating risk among Registrant, Merger Sub and Pharmasset, Inc. rather than establishing matters as facts.
|
*
|
Management contract or compensatory plan or arrangement.
|
**
|
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.
|
***
|
XBRL information is filed herewith.
|
+
|
Certain confidential portions of this Exhibit were omitted by means of marking such portions with an asterisk (the Mark). This Exhibit has been filed separately with the Secretary of the Securities and Exchange Commission without the Mark pursuant to Registrant's Application Requesting Confidential Treatment under Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
|
Report of Independent Registered Public Accounting Firm
|
|
|
Audited Consolidated Financial Statements:
|
|
|
|
||
|
||
|
||
|
||
|
||
|
|
December 31,
|
||||||
|
2013
|
|
2012
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
2,112,806
|
|
|
$
|
1,803,694
|
|
Short-term marketable securities
|
18,756
|
|
|
58,556
|
|
||
Accounts receivable, net of allowances of $334,307 at December 31, 2013 and $261,013 at December 31, 2012
|
2,100,286
|
|
|
1,751,388
|
|
||
Inventories
|
2,055,788
|
|
|
1,744,982
|
|
||
Deferred tax assets
|
330,530
|
|
|
262,641
|
|
||
Prepaid taxes
|
398,010
|
|
|
348,420
|
|
||
Prepaid expenses
|
165,652
|
|
|
102,364
|
|
||
Other current assets
|
91,925
|
|
|
84,302
|
|
||
Total current assets
|
7,273,753
|
|
|
6,156,347
|
|
||
Property, plant and equipment, net
|
1,166,181
|
|
|
1,100,259
|
|
||
Long-term portion of prepaid royalties
|
198,766
|
|
|
175,790
|
|
||
Long-term deferred tax assets
|
154,765
|
|
|
131,107
|
|
||
Long-term marketable securities
|
439,028
|
|
|
719,836
|
|
||
Intangible assets, net
|
11,900,106
|
|
|
11,736,393
|
|
||
Goodwill
|
1,169,023
|
|
|
1,060,919
|
|
||
Other long-term assets
|
195,163
|
|
|
159,187
|
|
||
Total assets
|
$
|
22,496,785
|
|
|
$
|
21,239,838
|
|
|
|
|
|
|
|
||
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
1,255,914
|
|
|
$
|
1,327,339
|
|
Accrued government rebates
|
983,490
|
|
|
745,148
|
|
||
Accrued compensation and employee benefits
|
243,540
|
|
|
204,593
|
|
||
Income taxes payable
|
10,855
|
|
|
13,403
|
|
||
Other accrued liabilities
|
1,023,938
|
|
|
674,762
|
|
||
Deferred revenues
|
110,640
|
|
|
103,162
|
|
||
Current portion of long-term debt and other obligations, net
|
2,697,044
|
|
|
1,169,490
|
|
||
Total current liabilities
|
6,325,421
|
|
|
4,237,897
|
|
||
Long-term deferred revenues
|
21,979
|
|
|
20,532
|
|
||
Long-term debt, net
|
3,938,708
|
|
|
7,054,555
|
|
||
Long-term income taxes payable
|
162,412
|
|
|
115,822
|
|
||
Long-term deferred tax liabilities
|
83,286
|
|
|
10,190
|
|
||
Other long-term obligations
|
156,647
|
|
|
249,973
|
|
||
Commitments and contingencies (Note 11)
|
|
|
|
|
|
||
Equity component of currently redeemable convertible notes (Note 10)
|
63,831
|
|
|
7,147
|
|
||
Stockholders’ equity:
|
|
|
|
|
|
||
Preferred stock, par value $0.001 per share; 5,000 shares authorized; none outstanding
|
—
|
|
|
—
|
|
||
Common stock, par value $0.001 per share; shares authorized of 5,600,000 at December 31, 2013 and 2,800,000 at December 31, 2012; shares issued and outstanding of 1,534,414 at December 31, 2013 and 1,519,163 at December 31, 2012
(1)
|
1,534
|
|
|
1,519
|
|
||
Additional paid-in capital
(1)
|
5,386,735
|
|
|
5,641,944
|
|
||
Accumulated other comprehensive loss
|
(124,446
|
)
|
|
(45,615
|
)
|
||
Retained earnings
|
6,105,244
|
|
|
3,704,744
|
|
||
Total Gilead stockholders’ equity
|
11,369,067
|
|
|
9,302,592
|
|
||
Noncontrolling interest
|
375,434
|
|
|
241,130
|
|
||
Total stockholders’ equity
|
11,744,501
|
|
|
9,543,722
|
|
||
Total liabilities and stockholders’ equity
|
$
|
22,496,785
|
|
|
$
|
21,239,838
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2013
|
|
2012
|
|
2011
|
||||||
Revenues:
|
|
|
|
|
|
|
||||||
Product sales
|
|
$
|
10,803,695
|
|
|
$
|
9,398,371
|
|
|
$
|
8,102,359
|
|
Royalty revenues
|
|
383,849
|
|
|
290,523
|
|
|
268,827
|
|
|||
Contract and other revenues
|
|
14,144
|
|
|
13,623
|
|
|
14,199
|
|
|||
Total revenues
|
|
11,201,688
|
|
|
9,702,517
|
|
|
8,385,385
|
|
|||
Costs and expenses:
|
|
|
|
|
|
|
||||||
Cost of goods sold
|
|
2,858,502
|
|
|
2,471,363
|
|
|
2,124,410
|
|
|||
Research and development expenses
|
|
2,119,756
|
|
|
1,759,945
|
|
|
1,229,151
|
|
|||
Selling, general and administrative expenses
|
|
1,699,431
|
|
|
1,461,034
|
|
|
1,241,983
|
|
|||
Total costs and expenses
|
|
6,677,689
|
|
|
5,692,342
|
|
|
4,595,544
|
|
|||
Income from operations
|
|
4,523,999
|
|
|
4,010,175
|
|
|
3,789,841
|
|
|||
Interest expense
|
|
(306,894
|
)
|
|
(360,916
|
)
|
|
(205,418
|
)
|
|||
Other income (expense), net
|
|
(8,886
|
)
|
|
(37,279
|
)
|
|
66,581
|
|
|||
Income before provision for income taxes
|
|
4,208,219
|
|
|
3,611,980
|
|
|
3,651,004
|
|
|||
Provision for income taxes
|
|
1,150,933
|
|
|
1,038,381
|
|
|
861,945
|
|
|||
Net income
|
|
3,057,286
|
|
|
2,573,599
|
|
|
2,789,059
|
|
|||
Net loss attributable to noncontrolling interest
|
|
17,522
|
|
|
17,967
|
|
|
14,578
|
|
|||
Net income attributable to Gilead
|
|
$
|
3,074,808
|
|
|
$
|
2,591,566
|
|
|
$
|
2,803,637
|
|
Net income per share attributable to Gilead common stockholders—basic
|
|
$
|
2.01
|
|
|
$
|
1.71
|
|
|
$
|
1.81
|
|
Shares used in per share calculation—basic
|
|
1,528,620
|
|
|
1,514,621
|
|
|
1,549,806
|
|
|||
Net income per share attributable to Gilead common stockholders—diluted
|
|
$
|
1.81
|
|
|
$
|
1.64
|
|
|
$
|
1.77
|
|
Shares used in per share calculation—diluted
|
|
1,694,747
|
|
|
1,582,549
|
|
|
1,580,236
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2013
|
|
2012
|
|
2011
|
||||||
Net income
|
|
$
|
3,057,286
|
|
|
$
|
2,573,599
|
|
|
$
|
2,789,059
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
||||||
Net foreign currency translation gain (loss), net of tax
|
|
(44,440
|
)
|
|
11,076
|
|
|
(5,264
|
)
|
|||
Available-for-sale securities:
|
|
|
|
|
|
|
||||||
Net unrealized gain (loss), net of tax impact of $3,741, $(703) and $(3,305)
|
|
4,867
|
|
|
1,242
|
|
|
(24,067
|
)
|
|||
Reclassifications to net income, net of tax impact of $(262), $849 and $(11,114)
|
|
(462
|
)
|
|
33,008
|
|
|
(19,209
|
)
|
|||
Net change
|
|
4,405
|
|
|
34,250
|
|
|
(43,276
|
)
|
|||
Cash flow hedges:
|
|
|
|
|
|
|
||||||
Net unrealized gain (loss), net of tax impact of $4,345, $1,566 and $(93)
|
|
(59,653
|
)
|
|
(62,505
|
)
|
|
1,571
|
|
|||
Reclassification to net income, net of tax impact of $(1,193), $(2,171) and $4,389
|
|
20,857
|
|
|
(86,636
|
)
|
|
74,258
|
|
|||
Net change
|
|
(38,796
|
)
|
|
(149,141
|
)
|
|
75,829
|
|
|||
Other comprehensive income (loss)
|
|
(78,831
|
)
|
|
(103,815
|
)
|
|
27,289
|
|
|||
Comprehensive income
|
|
2,978,455
|
|
|
2,469,784
|
|
|
2,816,348
|
|
|||
Comprehensive loss attributable to noncontrolling interest
|
|
17,522
|
|
|
17,967
|
|
|
14,578
|
|
|||
Comprehensive income attributable to Gilead
|
|
$
|
2,995,977
|
|
|
$
|
2,487,751
|
|
|
$
|
2,830,926
|
|
|
|
Gilead Stockholders' Equity
|
|
Noncontrolling
Interest
|
|
Total
Stockholders'
Equity
|
|||||||||||||||||||||
|
Common Stock
|
|
Additional
Paid-In
Capital
(1)
|
|
Accumulated
Other
Comprehensive
Income (Loss)
|
|
Retained
Earnings
|
|
|||||||||||||||||||
|
Shares
(1)
|
|
Amount
(1)
|
|
|
||||||||||||||||||||||
Balance at December 31, 2010
|
|
1,603,996
|
|
|
$
|
1,604
|
|
|
$
|
4,647,484
|
|
|
$
|
30,911
|
|
|
$
|
1,183,730
|
|
|
$
|
258,108
|
|
|
$
|
6,121,837
|
|
Distributions to noncontrolling interest
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(115,037
|
)
|
|
(115,037
|
)
|
||||||
Net income (loss)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,803,637
|
|
|
(14,578
|
)
|
|
2,789,059
|
|
||||||
Other comprehensive income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
27,289
|
|
|
—
|
|
|
—
|
|
|
27,289
|
|
||||||
Issuances under employee stock purchase plan
|
|
2,400
|
|
|
2
|
|
|
35,011
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
35,013
|
|
||||||
Issuances under equity incentive plans
|
|
18,350
|
|
|
18
|
|
|
176,690
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
176,708
|
|
||||||
Tax benefits from employee stock plans
|
|
—
|
|
|
—
|
|
|
37,231
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
37,231
|
|
||||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
192,030
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
192,030
|
|
||||||
Repurchases of common stock
|
|
(118,534
|
)
|
|
(118
|
)
|
|
(186,056
|
)
|
|
—
|
|
|
(2,210,607
|
)
|
|
—
|
|
|
(2,396,781
|
)
|
||||||
Convertible notes settlement
|
|
—
|
|
|
—
|
|
|
(36,148
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(36,148
|
)
|
||||||
Convertible notes hedge settlement
|
|
—
|
|
|
—
|
|
|
36,148
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
36,148
|
|
||||||
Balance at December 31, 2011
|
|
1,506,212
|
|
|
1,506
|
|
|
4,902,390
|
|
|
58,200
|
|
|
1,776,760
|
|
|
128,493
|
|
|
6,867,349
|
|
||||||
Contributions from noncontrolling interest
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
130,604
|
|
|
130,604
|
|
||||||
Net income (loss)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,591,566
|
|
|
(17,967
|
)
|
|
2,573,599
|
|
||||||
Other comprehensive loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(103,815
|
)
|
|
—
|
|
|
—
|
|
|
(103,815
|
)
|
||||||
Issuances under employee stock purchase plan
|
|
2,010
|
|
|
2
|
|
|
30,734
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
30,736
|
|
||||||
Issuances under equity incentive plans
|
|
31,693
|
|
|
31
|
|
|
435,752
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
435,783
|
|
||||||
Tax benefits from employee stock plans
|
|
—
|
|
|
—
|
|
|
112,629
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
112,629
|
|
||||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
208,230
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
208,230
|
|
||||||
Repurchases of common stock
|
|
(20,752
|
)
|
|
(20
|
)
|
|
(40,565
|
)
|
|
—
|
|
|
(663,582
|
)
|
|
—
|
|
|
(704,167
|
)
|
||||||
Convertible notes settlement
|
|
—
|
|
|
—
|
|
|
(213,935
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(213,935
|
)
|
||||||
Convertible notes hedge settlement
|
|
—
|
|
|
—
|
|
|
213,856
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
213,856
|
|
||||||
Reclassification to equity component of currently redeemable convertible notes
|
|
—
|
|
|
—
|
|
|
(7,147
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(7,147
|
)
|
||||||
Balance at December 31, 2012
|
|
1,519,163
|
|
|
1,519
|
|
|
5,641,944
|
|
|
(45,615
|
)
|
|
3,704,744
|
|
|
241,130
|
|
|
9,543,722
|
|
||||||
Contributions from noncontrolling interest
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
151,826
|
|
|
151,826
|
|
||||||
Net income (loss)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,074,808
|
|
|
(17,522
|
)
|
|
3,057,286
|
|
||||||
Other comprehensive loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(78,831
|
)
|
|
—
|
|
|
—
|
|
|
(78,831
|
)
|
||||||
Issuances under employee stock purchase plan
|
|
2,518
|
|
|
3
|
|
|
54,903
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
54,906
|
|
||||||
Issuances under equity incentive plans
|
|
24,432
|
|
|
24
|
|
|
258,173
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
258,197
|
|
||||||
Tax benefits from employee stock plans
|
|
—
|
|
|
—
|
|
|
284,655
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
284,655
|
|
||||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
254,316
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
254,316
|
|
||||||
Repurchases of common stock
|
|
(11,699
|
)
|
|
(12
|
)
|
|
(14,064
|
)
|
|
—
|
|
|
(674,308
|
)
|
|
—
|
|
|
(688,384
|
)
|
||||||
Warrants settlement
|
|
—
|
|
|
—
|
|
|
(1,039,695
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,039,695
|
)
|
||||||
Convertible notes settlement
|
|
—
|
|
|
—
|
|
|
(2,771,215
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,771,215
|
)
|
||||||
Convertible notes hedge settlement
|
|
—
|
|
|
—
|
|
|
2,774,402
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,774,402
|
|
||||||
Reclassification to equity component of currently redeemable convertible notes
|
|
—
|
|
|
—
|
|
|
(56,684
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(56,684
|
)
|
||||||
Balance at December 31, 2013
|
|
1,534,414
|
|
|
$
|
1,534
|
|
|
$
|
5,386,735
|
|
|
$
|
(124,446
|
)
|
|
$
|
6,105,244
|
|
|
$
|
375,434
|
|
|
$
|
11,744,501
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2013
|
|
2012
|
|
2011
|
||||||
Operating Activities:
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
3,057,286
|
|
|
$
|
2,573,599
|
|
|
$
|
2,789,059
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
|
|
|
||||||
Depreciation expense
|
|
102,644
|
|
|
82,847
|
|
|
72,187
|
|
|||
Amortization expense
|
|
242,060
|
|
|
195,359
|
|
|
230,045
|
|
|||
Stock-based compensation expense
|
|
251,984
|
|
|
208,725
|
|
|
192,378
|
|
|||
In-process research and development impairment charges
|
|
—
|
|
|
—
|
|
|
26,630
|
|
|||
Excess tax benefits from stock-based compensation
|
|
(278,773
|
)
|
|
(114,236
|
)
|
|
(40,848
|
)
|
|||
Tax benefits from employee stock plans
|
|
284,655
|
|
|
112,629
|
|
|
37,231
|
|
|||
Deferred income taxes
|
|
(98,181
|
)
|
|
(39,393
|
)
|
|
64,061
|
|
|||
Change in fair value of contingent consideration
|
|
58,700
|
|
|
69,469
|
|
|
8,483
|
|
|||
Other
|
|
47,289
|
|
|
(1,878
|
)
|
|
47,931
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
||||||
Accounts receivable, net
|
|
(315,299
|
)
|
|
197,986
|
|
|
(375,736
|
)
|
|||
Inventories
|
|
(343,143
|
)
|
|
(349,924
|
)
|
|
(200,793
|
)
|
|||
Prepaid expenses and other assets
|
|
(170,355
|
)
|
|
(129,318
|
)
|
|
(13,959
|
)
|
|||
Accounts payable
|
|
(97,673
|
)
|
|
117,485
|
|
|
428,944
|
|
|||
Income taxes payable
|
|
30,021
|
|
|
(68,473
|
)
|
|
110,771
|
|
|||
Accrued liabilities
|
|
311,628
|
|
|
316,594
|
|
|
292,110
|
|
|||
Deferred revenues
|
|
22,145
|
|
|
23,245
|
|
|
(29,484
|
)
|
|||
Net cash provided by operating activities
|
|
3,104,988
|
|
|
3,194,716
|
|
|
3,639,010
|
|
|||
|
|
|
|
|
|
|
||||||
Investing Activities:
|
|
|
|
|
|
|
||||||
Purchases of marketable securities
|
|
(256,700
|
)
|
|
(1,244,898
|
)
|
|
(5,127,790
|
)
|
|||
Proceeds from sales of marketable securities
|
|
494,117
|
|
|
527,712
|
|
|
8,649,752
|
|
|||
Proceeds from maturities of marketable securities
|
|
77,655
|
|
|
44,813
|
|
|
788,395
|
|
|||
Purchases of other investments
|
|
—
|
|
|
(25,000
|
)
|
|
—
|
|
|||
Acquisitions, net of cash acquired
|
|
(378,645
|
)
|
|
(10,751,635
|
)
|
|
(588,608
|
)
|
|||
Capital expenditures
|
|
(190,782
|
)
|
|
(397,046
|
)
|
|
(131,904
|
)
|
|||
Net cash provided by (used in) investing activities
|
|
(254,355
|
)
|
|
(11,846,054
|
)
|
|
3,589,845
|
|
|||
|
|
|
|
|
|
|
||||||
Financing Activities:
|
|
|
|
|
|
|
||||||
Proceeds from debt financing, net of issuance costs
|
|
—
|
|
|
2,144,733
|
|
|
4,660,702
|
|
|||
Proceeds from convertible note hedges
|
|
2,774,402
|
|
|
213,856
|
|
|
36,148
|
|
|||
Proceeds from issuances of common stock
|
|
313,079
|
|
|
466,283
|
|
|
211,737
|
|
|||
Repurchases of common stock
|
|
(582,358
|
)
|
|
(667,041
|
)
|
|
(2,383,132
|
)
|
|||
Repayments of debt financing
|
|
(4,439,891
|
)
|
|
(1,837,139
|
)
|
|
(686,135
|
)
|
|||
Payments to settle warrants
|
|
(1,039,695
|
)
|
|
—
|
|
|
—
|
|
|||
Repayments of other long-term obligations
|
|
(77
|
)
|
|
(2,186
|
)
|
|
(1,562
|
)
|
|||
Excess tax benefits from stock-based compensation
|
|
278,773
|
|
|
114,236
|
|
|
40,848
|
|
|||
Contributions from (distributions to) noncontrolling interest
|
|
151,826
|
|
|
130,604
|
|
|
(115,037
|
)
|
|||
Net cash provided by (used in) financing activities
|
|
(2,543,941
|
)
|
|
563,346
|
|
|
1,763,569
|
|
|||
Effect of exchange rate changes on cash
|
|
2,420
|
|
|
7,909
|
|
|
(16,526
|
)
|
|||
Net change in cash and cash equivalents
|
|
309,112
|
|
|
(8,080,083
|
)
|
|
8,975,898
|
|
|||
Cash and cash equivalents at beginning of period
|
|
1,803,694
|
|
|
9,883,777
|
|
|
907,879
|
|
|||
Cash and cash equivalents at end of period
|
|
$
|
2,112,806
|
|
|
$
|
1,803,694
|
|
|
$
|
9,883,777
|
|
|
|
|
|
|
|
|
||||||
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
||||||
Interest paid, net of amounts capitalized
|
|
$
|
238,325
|
|
|
$
|
249,358
|
|
|
$
|
62,180
|
|
Income taxes paid
|
|
$
|
1,050,588
|
|
|
$
|
1,101,241
|
|
|
$
|
621,025
|
|
1.
|
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
Description
|
Estimated Useful Life
|
Buildings and improvements
|
20-35
|
Laboratory and manufacturing equipment
|
4-10
|
Office and computer equipment
|
3-7
|
Leasehold improvements
|
Shorter of useful life
or lease term |
•
|
Level 1 inputs which include quoted prices in active markets for identical assets or liabilities;
|
•
|
Level 2 inputs which include observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the asset or liability. For our marketable securities, we review trading activity and pricing as of the measurement date. When sufficient quoted pricing for identical securities is not available, we use market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs either represent quoted prices for similar assets in active markets or have been derived from observable market data; and
|
•
|
Level 3 inputs which include unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the underlying asset or liability. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies or similar valuation techniques and significant management judgment or estimation.
|
2.
|
FAIR VALUE MEASUREMENTS
|
|
|
|
|
December 31, 2013
|
|
December 31, 2012
|
||||||||||||
Type of Borrowing
|
|
Description
|
|
Carrying Value
|
|
Fair Value
|
|
Carrying Value
|
|
Fair Value
|
||||||||
Convertible Senior
|
|
May 2013 Notes
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
419,433
|
|
|
$
|
815,297
|
|
Convertible Senior
|
|
May 2014 Notes
|
|
234,217
|
|
|
783,651
|
|
|
1,210,213
|
|
|
2,040,363
|
|
||||
Convertible Senior
|
|
May 2016 Notes
|
|
1,113,043
|
|
|
3,871,516
|
|
|
1,157,692
|
|
|
2,110,938
|
|
||||
Senior Unsecured
|
|
April 2021 Notes
|
|
993,781
|
|
|
1,075,480
|
|
|
992,923
|
|
|
1,146,990
|
|
||||
Senior Unsecured
|
|
December 2014 Notes
|
|
749,710
|
|
|
762,637
|
|
|
749,394
|
|
|
772,650
|
|
||||
Senior Unsecured
|
|
December 2016 Notes
|
|
699,326
|
|
|
740,705
|
|
|
699,095
|
|
|
748,902
|
|
||||
Senior Unsecured
|
|
December 2021 Notes
|
|
1,247,716
|
|
|
1,336,738
|
|
|
1,247,428
|
|
|
1,420,725
|
|
||||
Senior Unsecured
|
|
December 2041 Notes
|
|
997,885
|
|
|
1,118,660
|
|
|
997,810
|
|
|
1,252,090
|
|
|
December 31, 2013
|
|
December 31, 2012
|
||||||||||||||||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Debt securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
U.S. treasury securities
|
$
|
85,403
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
85,403
|
|
|
$
|
81,903
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
81,903
|
|
Money market funds
|
1,490,964
|
|
|
—
|
|
|
—
|
|
|
1,490,964
|
|
|
1,416,356
|
|
|
—
|
|
|
—
|
|
|
1,416,356
|
|
||||||||
U.S. government agencies securities
|
—
|
|
|
93,350
|
|
|
—
|
|
|
93,350
|
|
|
—
|
|
|
248,952
|
|
|
—
|
|
|
248,952
|
|
||||||||
Municipal debt securities
|
—
|
|
|
12,065
|
|
|
—
|
|
|
12,065
|
|
|
—
|
|
|
12,088
|
|
|
—
|
|
|
12,088
|
|
||||||||
Corporate debt securities
|
—
|
|
|
220,025
|
|
|
—
|
|
|
220,025
|
|
|
—
|
|
|
352,717
|
|
|
—
|
|
|
352,717
|
|
||||||||
Residential mortgage and asset-backed securities
|
—
|
|
|
46,941
|
|
|
—
|
|
|
46,941
|
|
|
—
|
|
|
82,732
|
|
|
—
|
|
|
82,732
|
|
||||||||
Total debt securities
|
1,576,367
|
|
|
372,381
|
|
|
—
|
|
|
1,948,748
|
|
|
1,498,259
|
|
|
696,489
|
|
|
—
|
|
|
2,194,748
|
|
||||||||
Deferred compensation plan
(1)
|
44,461
|
|
|
—
|
|
|
—
|
|
|
44,461
|
|
|
32,123
|
|
|
—
|
|
|
—
|
|
|
32,123
|
|
||||||||
Derivatives
|
—
|
|
|
13,879
|
|
|
—
|
|
|
13,879
|
|
|
—
|
|
|
14,823
|
|
|
—
|
|
|
14,823
|
|
||||||||
|
$
|
1,620,828
|
|
|
$
|
386,260
|
|
|
$
|
—
|
|
|
$
|
2,007,088
|
|
|
$
|
1,530,382
|
|
|
$
|
711,312
|
|
|
$
|
—
|
|
|
$
|
2,241,694
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Contingent consideration
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
263,760
|
|
|
$
|
263,760
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
205,060
|
|
|
$
|
205,060
|
|
Deferred compensation plan
(1)
|
44,461
|
|
|
—
|
|
|
—
|
|
|
44,461
|
|
|
32,123
|
|
|
—
|
|
|
—
|
|
|
32,123
|
|
||||||||
Derivatives
|
—
|
|
|
99,057
|
|
|
—
|
|
|
99,057
|
|
|
—
|
|
|
65,248
|
|
|
—
|
|
|
65,248
|
|
||||||||
|
$
|
44,461
|
|
|
$
|
99,057
|
|
|
$
|
263,760
|
|
|
$
|
407,278
|
|
|
$
|
32,123
|
|
|
$
|
65,248
|
|
|
$
|
205,060
|
|
|
$
|
302,431
|
|
|
Year Ended December 31,
|
||||||
|
2013
|
|
2012
|
||||
Fair value, beginning of period
|
$
|
—
|
|
|
$
|
71,693
|
|
Total realized and unrealized gains (losses) included in:
|
|
|
|
|
|
||
Other income (expense), net
|
—
|
|
|
(40,096
|
)
|
||
Other comprehensive income (loss), net
|
—
|
|
|
32,630
|
|
||
Sales of marketable securities
|
—
|
|
|
(64,227
|
)
|
||
Fair value, end of period
|
$
|
—
|
|
|
$
|
—
|
|
|
|
Year Ended December 31,
|
||||||
|
|
2013
|
|
2012
|
||||
Balance, beginning of period
|
|
$
|
205,060
|
|
|
$
|
135,591
|
|
Additions from new acquisitions
|
|
—
|
|
|
—
|
|
||
Net changes in valuation
|
|
58,700
|
|
|
69,469
|
|
||
Balance, end of period
|
|
$
|
263,760
|
|
|
$
|
205,060
|
|
3.
|
AVAILABLE-FOR-SALE SECURITIES
|
|
|
December 31, 2013
|
|
December 31, 2012
|
||||||||||||||||||||||||||||
|
|
Amortized
Cost |
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Estimated
Fair Value |
|
Amortized
Cost |
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Estimated
Fair Value |
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Debt securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
U.S. treasury securities
|
|
$
|
85,337
|
|
|
$
|
94
|
|
|
$
|
(28
|
)
|
|
$
|
85,403
|
|
|
$
|
81,752
|
|
|
$
|
151
|
|
|
$
|
—
|
|
|
$
|
81,903
|
|
Money market funds
|
|
1,490,964
|
|
|
—
|
|
|
—
|
|
|
1,490,964
|
|
|
1,416,356
|
|
|
—
|
|
|
—
|
|
|
1,416,356
|
|
||||||||
U.S. government agencies securities
|
|
93,211
|
|
|
156
|
|
|
(17
|
)
|
|
93,350
|
|
|
248,595
|
|
|
386
|
|
|
(29
|
)
|
|
248,952
|
|
||||||||
Municipal debt securities
|
|
12,009
|
|
|
56
|
|
|
—
|
|
|
12,065
|
|
|
12,062
|
|
|
33
|
|
|
(7
|
)
|
|
12,088
|
|
||||||||
Corporate debt securities
|
|
219,242
|
|
|
885
|
|
|
(102
|
)
|
|
220,025
|
|
|
351,309
|
|
|
1,492
|
|
|
(84
|
)
|
|
352,717
|
|
||||||||
Residential mortgage and asset-backed securities
|
|
46,969
|
|
|
37
|
|
|
(65
|
)
|
|
46,941
|
|
|
82,717
|
|
|
156
|
|
|
(141
|
)
|
|
82,732
|
|
||||||||
Total
|
|
$
|
1,947,732
|
|
|
$
|
1,228
|
|
|
$
|
(212
|
)
|
|
$
|
1,948,748
|
|
|
$
|
2,192,791
|
|
|
$
|
2,218
|
|
|
$
|
(261
|
)
|
|
$
|
2,194,748
|
|
|
December 31, 2013
|
|
December 31, 2012
|
||||
Cash and cash equivalents
|
$
|
1,490,964
|
|
|
$
|
1,416,356
|
|
Short-term marketable securities
|
18,756
|
|
|
58,556
|
|
||
Long-term marketable securities
|
439,028
|
|
|
719,836
|
|
||
Total
|
$
|
1,948,748
|
|
|
$
|
2,194,748
|
|
|
|
December 31, 2013
|
||||||
|
|
Amortized Cost
|
|
Fair Value
|
||||
Less than one year
|
|
$
|
1,509,677
|
|
|
$
|
1,509,720
|
|
Greater than one year but less than five years
|
|
432,502
|
|
|
433,515
|
|
||
Greater than five years but less than ten years
|
|
—
|
|
|
—
|
|
||
Greater than ten years
|
|
5,553
|
|
|
5,513
|
|
||
Total
|
|
$
|
1,947,732
|
|
|
$
|
1,948,748
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2013
|
|
2012
|
|
2011
|
||||||
Gross realized gains on sales
|
|
$
|
1,309
|
|
|
$
|
10,451
|
|
|
$
|
42,849
|
|
Gross realized losses on sales
|
|
$
|
(585
|
)
|
|
$
|
(44,308
|
)
|
|
$
|
(12,526
|
)
|
|
|
Less Than 12 Months
|
|
12 Months or Greater
|
|
Total
|
||||||||||||||||||
|
|
Gross
Unrealized Losses |
|
Estimated
Fair Value |
|
Gross
Unrealized Losses |
|
Estimated
Fair Value |
|
Gross
Unrealized Losses |
|
Estimated
Fair Value |
||||||||||||
December 31, 2013
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Debt securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
U.S. treasury securities
|
|
$
|
(28
|
)
|
|
$
|
24,562
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(28
|
)
|
|
$
|
24,562
|
|
U.S. government agencies securities
|
|
(17
|
)
|
|
10,858
|
|
|
—
|
|
|
—
|
|
|
(17
|
)
|
|
10,858
|
|
||||||
Municipal debt securities
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Corporate debt securities
|
|
(102
|
)
|
|
37,076
|
|
|
—
|
|
|
1,505
|
|
|
(102
|
)
|
|
38,581
|
|
||||||
Residential mortgage and asset-backed securities
|
|
(38
|
)
|
|
19,563
|
|
|
(27
|
)
|
|
6,731
|
|
|
(65
|
)
|
|
26,294
|
|
||||||
Total
|
|
$
|
(185
|
)
|
|
$
|
92,059
|
|
|
$
|
(27
|
)
|
|
$
|
8,236
|
|
|
$
|
(212
|
)
|
|
$
|
100,295
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
December 31, 2012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Debt securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
U.S. treasury securities
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
U.S. government agencies securities
|
|
(29
|
)
|
|
26,306
|
|
|
—
|
|
|
—
|
|
|
(29
|
)
|
|
26,306
|
|
||||||
Municipal debt securities
|
|
(7
|
)
|
|
3,993
|
|
|
—
|
|
|
—
|
|
|
(7
|
)
|
|
3,993
|
|
||||||
Corporate debt securities
|
|
(84
|
)
|
|
72,722
|
|
|
—
|
|
|
—
|
|
|
(84
|
)
|
|
72,722
|
|
||||||
Residential mortgage and asset-backed securities
|
|
(141
|
)
|
|
36,415
|
|
|
—
|
|
|
—
|
|
|
(141
|
)
|
|
36,415
|
|
||||||
Total
|
|
$
|
(261
|
)
|
|
$
|
139,436
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(261
|
)
|
|
$
|
139,436
|
|
4.
|
DERIVATIVE FINANCIAL INSTRUMENTS
|
|
|
December 31, 2013
|
||||||||||
|
|
Asset Derivatives
|
|
Liability Derivatives
|
||||||||
|
|
Classification
|
|
Fair Value
|
|
Classification
|
|
Fair Value
|
||||
Derivatives designated as hedges:
|
|
|
|
|
|
|
|
|
||||
Foreign currency exchange contracts
|
|
Other current assets
|
|
$
|
12,647
|
|
|
Other accrued liabilities
|
|
$
|
85,541
|
|
Foreign currency exchange contracts
|
|
Other long-term assets
|
|
1,229
|
|
|
Other long-term obligations
|
|
13,299
|
|
||
Total derivatives designated as hedges
|
|
|
|
13,876
|
|
|
|
|
98,840
|
|
||
Derivatives not designated as hedges:
|
|
|
|
|
|
|
|
|
|
|
||
Foreign currency exchange contracts
|
|
Other current assets
|
|
3
|
|
|
Other accrued liabilities
|
|
217
|
|
||
Total derivatives not designated as hedges
|
|
|
|
3
|
|
|
|
|
217
|
|
||
Total derivatives
|
|
|
|
$
|
13,879
|
|
|
|
|
$
|
99,057
|
|
|
|
December 31, 2012
|
||||||||||
|
|
Asset Derivatives
|
|
Liability Derivatives
|
||||||||
|
|
Classification
|
|
Fair Value
|
|
Classification
|
|
Fair Value
|
||||
Derivatives designated as hedges:
|
|
|
|
|
|
|
|
|
||||
Foreign currency exchange contracts
|
|
Other current assets
|
|
$
|
14,556
|
|
|
Other accrued liabilities
|
|
$
|
54,597
|
|
Foreign currency exchange contracts
|
|
Other long-term assets
|
|
142
|
|
|
Other long-term obligations
|
|
10,630
|
|
||
Total derivatives designated as hedges
|
|
|
|
14,698
|
|
|
|
|
65,227
|
|
||
Derivatives not designated as hedges:
|
|
|
|
|
|
|
|
|
|
|
||
Foreign currency exchange contracts
|
|
Other current assets
|
|
125
|
|
|
Other accrued liabilities
|
|
21
|
|
||
Total derivatives not designated as hedges
|
|
|
|
125
|
|
|
|
|
21
|
|
||
Total derivatives
|
|
|
|
$
|
14,823
|
|
|
|
|
$
|
65,248
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2013
|
|
2012
|
|
2011
|
||||||
Derivatives designated as hedges:
|
|
|
|
|
|
|
||||||
Gains (losses) recognized in OCI (effective portion)
|
|
$
|
(55,308
|
)
|
|
$
|
(62,258
|
)
|
|
$
|
1,664
|
|
Gains (losses) reclassified from accumulated OCI into product sales (effective portion)
|
|
$
|
(19,664
|
)
|
|
$
|
88,807
|
|
|
$
|
(78,647
|
)
|
Gains (losses) recognized in other income (expense), net (ineffective portion and amounts excluded from effectiveness testing)
|
|
$
|
1,645
|
|
|
$
|
(8,444
|
)
|
|
$
|
(17,237
|
)
|
Derivatives not designated as hedges:
|
|
|
|
|
|
|
|
|
|
|||
Gains (losses) recognized in other income (expense), net
|
|
$
|
(16,550
|
)
|
|
$
|
(1,099
|
)
|
|
$
|
22,084
|
|
December 31, 2013
|
||||||||||||||||||||||||
Offsetting of Derivative Assets/Liabilities
|
||||||||||||||||||||||||
|
|
|
|
|
|
|
|
Gross Amounts Not Offset in the Consolidated Balance Sheet
|
|
|
||||||||||||||
Description
|
|
Gross Amounts of Recognized Assets/Liabilities
|
|
Gross Amounts Offset in the Consolidated Balance Sheet
|
|
Amounts of Assets/Liabilities Presented
in the Consolidated
Balance Sheet
|
|
Derivative Financial Instruments
|
|
Cash Collateral Received/Pledged
|
|
Net Amount (Legal Offset)
|
||||||||||||
Derivative assets
|
|
$
|
13,879
|
|
|
$
|
—
|
|
|
$
|
13,879
|
|
|
$
|
(13,879
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
Derivative liabilities
|
|
(99,057
|
)
|
|
—
|
|
|
(99,057
|
)
|
|
13,879
|
|
|
—
|
|
|
(85,178
|
)
|
||||||
|
||||||||||||||||||||||||
December 31, 2012
|
||||||||||||||||||||||||
Offsetting of Derivative Assets/Liabilities
|
||||||||||||||||||||||||
|
|
|
|
|
|
|
|
Gross Amounts Not Offset in the Consolidated Balance Sheet
|
|
|
||||||||||||||
Description
|
|
Gross Amounts of Recognized Assets/Liabilities
|
|
Gross Amounts Offset in the Consolidated Balance Sheet
|
|
Amounts of Assets/Liabilities Presented in the Consolidated Balance Sheet
|
|
Derivative Financial Instruments
|
|
Cash Collateral Received/Pledged
|
|
Net Amount (Legal Offset)
|
||||||||||||
Derivative assets
|
|
$
|
14,823
|
|
|
$
|
—
|
|
|
$
|
14,823
|
|
|
$
|
(9,644
|
)
|
|
$
|
—
|
|
|
$
|
5,179
|
|
Derivative liabilities
|
|
(65,248
|
)
|
|
—
|
|
|
(65,248
|
)
|
|
9,644
|
|
|
—
|
|
|
(55,604
|
)
|
5.
|
ACQUISITIONS
|
Total consideration transferred
|
|
$
|
10,858,372
|
|
Stock-based compensation expense
|
|
193,937
|
|
|
Total cash paid
|
|
$
|
11,052,309
|
|
Identifiable intangible assets
|
|
$
|
10,738,000
|
|
Cash and cash equivalents
|
|
106,737
|
|
|
Other assets acquired (liabilities assumed), net
|
|
(43,182
|
)
|
|
Total identifiable net assets
|
|
10,801,555
|
|
|
Goodwill
|
|
56,817
|
|
|
Total consideration transferred
|
|
$
|
10,858,372
|
|
|
|
Year Ended
|
||
|
|
December 31, 2012
|
||
Research and development expense
|
|
$
|
100,149
|
|
Selling, general and administrative expense
|
|
93,788
|
|
|
Total stock-based compensation expense
|
|
$
|
193,937
|
|
|
|
Year Ended December 31,
|
||||||
|
|
2012
|
|
2011
|
||||
Transaction costs (e.g. investment advisory, legal and accounting fees)
|
|
$
|
10,635
|
|
|
$
|
28,461
|
|
Bridge financing costs
|
|
7,333
|
|
|
23,817
|
|
||
Restructuring costs
|
|
15,125
|
|
|
—
|
|
||
Total other costs
|
|
$
|
33,093
|
|
|
$
|
52,278
|
|
|
|
Year Ended December 31,
|
||||||
|
|
2012
|
|
2011
|
||||
Research and development expense
|
|
$
|
7,906
|
|
|
$
|
—
|
|
Selling, general and administrative expense
|
|
17,854
|
|
|
28,461
|
|
||
Interest expense
|
|
7,333
|
|
|
23,817
|
|
||
Total other costs
|
|
$
|
33,093
|
|
|
$
|
52,278
|
|
|
|
Year Ended December 31,
|
||||||
|
|
2012
|
|
2011
|
||||
Total revenues
|
|
$
|
9,702,517
|
|
|
$
|
8,385,385
|
|
Net income attributable to Gilead
|
|
$
|
2,745,911
|
|
|
$
|
2,389,364
|
|
IPR&D
|
|
$
|
149,200
|
|
Other net liabilities assumed
|
|
(1,853
|
)
|
|
Total identifiable assets
|
|
$
|
147,347
|
|
Goodwill
|
|
336,951
|
|
|
Total consideration transferred
|
|
$
|
484,298
|
|
IPR&D
|
|
$
|
117,000
|
|
Deferred tax assets
|
|
17,417
|
|
|
Deferred tax liabilities
|
|
(41,705
|
)
|
|
Other net liabilities assumed
|
|
(125
|
)
|
|
Total identifiable net assets
|
|
$
|
92,587
|
|
Goodwill
|
|
134,482
|
|
|
Total consideration transferred
|
|
$
|
227,069
|
|
6.
|
INVENTORIES
|
|
|
December 31,
|
||||||
|
|
2013
|
|
2012
|
||||
Raw materials
|
|
$
|
1,049,403
|
|
|
$
|
826,545
|
|
Work in process
|
|
412,945
|
|
|
358,525
|
|
||
Finished goods
|
|
593,440
|
|
|
559,912
|
|
||
Total
|
|
$
|
2,055,788
|
|
|
$
|
1,744,982
|
|
7.
|
PROPERTY, PLANT AND EQUIPMENT
|
|
|
December 31,
|
||||||
|
|
2013
|
|
2012
|
||||
Property, plant and equipment, net:
|
|
|
|
|
||||
Buildings and improvements (including leasehold improvements)
|
|
$
|
834,910
|
|
|
$
|
670,470
|
|
Laboratory and manufacturing equipment
|
|
250,167
|
|
|
205,097
|
|
||
Office and computer equipment
|
|
255,960
|
|
|
233,987
|
|
||
Capitalized leased equipment
|
|
1,801
|
|
|
1,758
|
|
||
Construction in progress
|
|
129,400
|
|
|
216,434
|
|
||
Subtotal
|
|
1,472,238
|
|
|
1,327,746
|
|
||
Less accumulated depreciation and amortization (including $1,623 for 2013 and $1,525 for 2012 relating to capitalized leased equipment)
|
|
(501,967
|
)
|
|
(423,300
|
)
|
||
Subtotal
|
|
970,271
|
|
|
904,446
|
|
||
Land
|
|
195,910
|
|
|
195,813
|
|
||
Total
|
|
$
|
1,166,181
|
|
|
$
|
1,100,259
|
|
8.
|
INTANGIBLE ASSETS AND GOODWILL
|
|
|
December 31,
|
||||||
|
|
2013
|
|
2012
|
||||
Indefinite-lived intangible assets
|
|
$
|
574,355
|
|
|
$
|
10,986,200
|
|
Finite-lived intangible assets
|
|
11,325,751
|
|
|
750,193
|
|
||
Total intangible assets
|
|
$
|
11,900,106
|
|
|
$
|
11,736,393
|
|
|
|
December 31,
|
||||||
|
|
2013
|
|
2012
|
||||
Indefinite-lived intangible asset - Sovaldi (sofosbuvir)
|
|
$
|
—
|
|
|
$
|
10,720,000
|
|
Indefinite-lived intangible asset - Momelotinib (formerly CYT387)
|
|
362,700
|
|
|
—
|
|
||
Indefinite-lived intangible assets - Other
|
|
266,200
|
|
|
266,200
|
|
||
|
|
628,900
|
|
|
10,986,200
|
|
||
Foreign currency translation adjustment
|
|
(54,545
|
)
|
|
—
|
|
||
Total
|
|
$
|
574,355
|
|
|
$
|
10,986,200
|
|
|
|
December 31, 2013
|
|
December 31, 2012
|
||||||||||||
|
|
Gross Carrying
Amount
|
|
Accumulated
Amortization
|
|
Gross Carrying
Amount
|
|
Accumulated
Amortization
|
||||||||
Intangible asset - Sofosbuvir
|
|
$
|
10,720,000
|
|
|
$
|
58,261
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Intangible asset - Ranexa
|
|
688,400
|
|
|
190,849
|
|
|
688,400
|
|
|
133,119
|
|
||||
Intangible asset - Lexiscan
|
|
262,800
|
|
|
121,210
|
|
|
262,800
|
|
|
95,466
|
|
||||
Other
|
|
42,995
|
|
|
18,124
|
|
|
42,995
|
|
|
15,417
|
|
||||
Total
|
|
$
|
11,714,195
|
|
|
$
|
388,444
|
|
|
$
|
994,195
|
|
|
$
|
244,002
|
|
Fiscal Year
|
Amount
|
||
2014
|
$
|
798,044
|
|
2015
|
803,496
|
|
|
2016
|
811,428
|
|
|
2017
|
815,872
|
|
|
2018
|
827,980
|
|
|
Total
|
$
|
4,056,820
|
|
Balance at December 31, 2012
|
$
|
1,060,919
|
|
Goodwill resulting from the acquisition of YM
|
127,238
|
|
|
Foreign currency translation adjustment
|
(19,134
|
)
|
|
Balance at December 31, 2013
|
$
|
1,169,023
|
|
9.
|
COLLABORATIVE ARRANGEMENTS
|
10.
|
DEBT AND CREDIT FACILITY
|
|
|
|
|
|
|
|
|
Interest
|
|
December 31,
|
||||||
Type of Borrowing
|
|
Description
|
|
Issue Date
|
|
Due Date
|
|
Rate
|
|
2013
|
|
2012
|
||||
Convertible Senior
|
|
May 2013 Notes
|
|
April 2006
|
|
May 2013
|
|
0.625%
|
|
$
|
—
|
|
|
$
|
419,433
|
|
Convertible Senior
|
|
May 2014 Notes
|
|
July 2010
|
|
May 2014
|
|
1.00%
|
|
234,217
|
|
|
1,210,213
|
|
||
Convertible Senior
|
|
May 2016 Notes
|
|
July 2010
|
|
May 2016
|
|
1.625%
|
|
1,113,043
|
|
|
1,157,692
|
|
||
Senior Unsecured
|
|
April 2021 Notes
|
|
March 2011
|
|
April 2021
|
|
4.50%
|
|
993,781
|
|
|
992,923
|
|
||
Senior Unsecured
|
|
December 2014 Notes
|
|
December 2011
|
|
December 2014
|
|
2.40%
|
|
749,710
|
|
|
749,394
|
|
||
Senior Unsecured
|
|
December 2016 Notes
|
|
December 2011
|
|
December 2016
|
|
3.05%
|
|
699,326
|
|
|
699,095
|
|
||
Senior Unsecured
|
|
December 2021 Notes
|
|
December 2011
|
|
December 2021
|
|
4.40%
|
|
1,247,716
|
|
|
1,247,428
|
|
||
Senior Unsecured
|
|
December 2041 Notes
|
|
December 2011
|
|
December 2041
|
|
5.65%
|
|
997,885
|
|
|
997,810
|
|
||
Credit Facility
|
|
Five-Year Revolver
|
|
January 2012
|
|
January 2017
|
|
Variable
|
|
600,000
|
|
|
750,000
|
|
||
Total debt, net
|
|
6,635,678
|
|
|
8,223,988
|
|
||||||||||
Less current portion
|
|
2,696,970
|
|
|
1,169,433
|
|
||||||||||
Total long-term debt, net
|
|
$
|
3,938,708
|
|
|
$
|
7,054,555
|
|
|
|
Carrying Value of
Equity Component
|
|
Net Carrying Amount of
Liability Component
|
|
Unamortized Discount of
Liability Component
|
||||||||||||||||||
|
|
December 31,
|
|
December 31,
|
|
December 31,
|
||||||||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||||||
May 2013 convertible senior notes
|
|
$
|
—
|
|
|
$
|
126,839
|
|
|
$
|
—
|
|
|
$
|
419,433
|
|
|
$
|
—
|
|
|
$
|
(7,147
|
)
|
|
|
Carrying Value of
Equity Component
|
|
Net Carrying Amount of
Liability Component
|
|
Unamortized Discount of
Liability Component
|
||||||||||||||||||
|
|
December 31,
|
|
December 31,
|
|
December 31,
|
||||||||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||||||
May 2014 convertible senior notes
|
|
$
|
20,306
|
|
|
$
|
107,496
|
|
|
$
|
234,217
|
|
|
$
|
1,210,213
|
|
|
$
|
(1,907
|
)
|
|
$
|
(39,787
|
)
|
May 2016 convertible senior notes
|
|
142,912
|
|
|
152,039
|
|
|
1,113,043
|
|
|
1,157,692
|
|
|
(61,924
|
)
|
|
(92,308
|
)
|
||||||
Total May 2014 and 2016 convertible senior notes
|
|
$
|
163,218
|
|
|
$
|
259,535
|
|
|
$
|
1,347,260
|
|
|
$
|
2,367,905
|
|
|
$
|
(63,831
|
)
|
|
$
|
(132,095
|
)
|
Maturity Date
|
Amount
|
||
2014
|
$
|
2,761,091
|
|
2015
|
—
|
|
|
2016
|
700,000
|
|
|
2017
|
—
|
|
|
2018
|
—
|
|
|
Total
|
$
|
3,461,091
|
|
11.
|
COMMITMENTS AND CONTINGENCIES
|
2014
|
$
|
48,976
|
|
2015
|
46,345
|
|
|
2016
|
41,384
|
|
|
2017
|
32,482
|
|
|
2018
|
25,204
|
|
|
Thereafter
|
31,922
|
|
|
Total
|
$
|
226,313
|
|
12.
|
STOCKHOLDERS' EQUITY
|
|
|
Year ended December 31,
|
||||||||||
|
|
2013
|
|
2012
|
|
2011
|
||||||
Reduction of common stock and APIC
|
|
$
|
14,076
|
|
|
$
|
40,585
|
|
|
$
|
186,174
|
|
Charge to retained earnings
|
|
$
|
674,308
|
|
|
$
|
663,582
|
|
|
$
|
2,210,607
|
|
|
|
Foreign Currency Items
|
|
Unrealized Gains and Losses on Available-for-Sale Securities
|
|
Unrealized Gains and Losses on Cash Flow Hedges
|
|
Total
|
||||||||
Balance at December 31, 2012
|
|
$
|
(1,420
|
)
|
|
$
|
7,502
|
|
|
$
|
(51,697
|
)
|
|
$
|
(45,615
|
)
|
Other comprehensive income (loss) before reclassifications
|
|
(44,440
|
)
|
|
4,867
|
|
|
(59,653
|
)
|
|
(99,226
|
)
|
||||
Amounts reclassified from accumulated other comprehensive income
|
|
—
|
|
|
(462
|
)
|
|
20,857
|
|
|
20,395
|
|
||||
Net current period other comprehensive income (loss)
|
|
(44,440
|
)
|
|
4,405
|
|
|
(38,796
|
)
|
|
(78,831
|
)
|
||||
Balance at December 31, 2013
|
|
$
|
(45,860
|
)
|
|
$
|
11,907
|
|
|
$
|
(90,493
|
)
|
|
$
|
(124,446
|
)
|
|
|
Shares
|
|
Weighted-
Average
Exercise Price
|
|
Weighted-Average Remaining Contractual Term (Years)
|
|
Aggregate Intrinsic Value
|
|||||
Outstanding at December 31, 2012
|
|
72,247
|
|
|
$
|
17.21
|
|
|
|
|
|
||
Granted and assumed
|
|
2,155
|
|
|
$
|
41.65
|
|
|
|
|
|
||
Forfeited
|
|
(668
|
)
|
|
$
|
24.57
|
|
|
|
|
|
||
Expired
|
|
(20
|
)
|
|
$
|
12.43
|
|
|
|
|
|
||
Exercised
|
|
(19,011
|
)
|
|
$
|
13.58
|
|
|
|
|
|
||
Outstanding at December 31, 2013
|
|
54,703
|
|
|
$
|
19.34
|
|
|
4.1
|
|
$
|
3,049,967
|
|
Exercisable at December 31, 2013
|
|
47,035
|
|
|
$
|
18.02
|
|
|
3.5
|
|
$
|
2,684,613
|
|
Expected to vest, net of estimated forfeitures at December 31, 2013
|
|
7,215
|
|
|
$
|
27.05
|
|
|
7.5
|
|
$
|
346,673
|
|
|
|
Shares
|
|
Weighted-Average Grant-Date Fair Value Per Share
(1)
|
|||
Outstanding at December 31, 2012
|
|
2,785
|
|
|
$
|
22.11
|
|
Granted
|
|
398
|
|
|
$
|
30.16
|
|
Vested
|
|
(417
|
)
|
|
$
|
26.99
|
|
Forfeited
|
|
(488
|
)
|
|
$
|
26.56
|
|
Outstanding at December 31, 2013
|
|
2,278
|
|
|
$
|
24.06
|
|
|
|
Shares
|
|
Weighted-Average Grant-Date Fair Value Per Share
|
|||
Outstanding at December 31, 2012
|
|
17,175
|
|
|
$
|
24.17
|
|
Granted and assumed
|
|
6,236
|
|
|
$
|
48.61
|
|
Vested
|
|
(5,002
|
)
|
|
$
|
23.63
|
|
Forfeited
|
|
(1,108
|
)
|
|
$
|
27.39
|
|
Outstanding at December 31, 2013
|
|
17,301
|
|
|
$
|
32.89
|
|
13.
|
STOCK-BASED COMPENSATION
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2013
|
|
2012
|
|
2011
|
||||||
Cost of goods sold
|
|
$
|
6,809
|
|
|
$
|
7,061
|
|
|
$
|
8,433
|
|
Research and development expenses
|
|
108,772
|
|
|
187,100
|
|
|
73,490
|
|
|||
Selling, general and administrative expenses
|
|
136,630
|
|
|
208,501
|
|
|
110,455
|
|
|||
Stock-based compensation expense included in total costs and expenses
|
|
252,211
|
|
|
402,662
|
|
|
192,378
|
|
|||
Income tax effect
|
|
(66,909
|
)
|
|
(55,957
|
)
|
|
(47,325
|
)
|
|||
Stock-based compensation expense, net of tax
|
|
$
|
185,302
|
|
|
$
|
346,705
|
|
|
$
|
145,053
|
|
|
|
Year Ended December 31,
|
|||||||
|
|
2013
|
|
2012
|
|
2011
|
|||
Expected volatility:
|
|
|
|
|
|
|
|||
Stock options
|
|
29
|
%
|
|
30
|
%
|
|
29
|
%
|
ESPP
|
|
31
|
%
|
|
32
|
%
|
|
30
|
%
|
Expected term in years:
|
|
|
|
|
|
|
|
|
|
Stock options
|
|
5.7
|
|
|
5.9
|
|
|
5.6
|
|
ESPP
|
|
1.2
|
|
|
1.3
|
|
|
1.4
|
|
Risk-free interest rate:
|
|
|
|
|
|
|
|
|
|
Stock options
|
|
1.1
|
%
|
|
1.1
|
%
|
|
2.2
|
%
|
ESPP
|
|
1.1
|
%
|
|
0.7
|
%
|
|
0.8
|
%
|
Expected dividend yield
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
14.
|
NET INCOME PER SHARE ATTRIBUTABLE TO GILEAD COMMON STOCKHOLDERS
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2013
|
|
2012
|
|
2011
|
||||||
Numerator:
|
|
|
|
|
|
|
||||||
Net income attributable to Gilead
|
|
$
|
3,074,808
|
|
|
$
|
2,591,566
|
|
|
$
|
2,803,637
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|||
Weighted-average shares of common stock outstanding used in the calculation of basic net income per share attributable to Gilead common stockholders
|
|
1,528,620
|
|
|
1,514,621
|
|
|
1,549,806
|
|
|||
Effect of dilutive securities:
|
|
|
|
|
|
|
|
|
|
|||
Stock options and equivalents
|
|
39,525
|
|
|
33,364
|
|
|
28,496
|
|
|||
Conversion spread related to the May 2011 Notes
|
|
—
|
|
|
—
|
|
|
374
|
|
|||
Conversion spread related to the May 2013 Notes
|
|
4,131
|
|
|
10,930
|
|
|
1,560
|
|
|||
Conversion spread related to the May 2014 Notes
|
|
26,721
|
|
|
11,230
|
|
|
—
|
|
|||
Conversion spread related to the May 2016 Notes
|
|
32,488
|
|
|
10,822
|
|
|
—
|
|
|||
Warrants related to the Convertible Notes
|
|
63,262
|
|
|
1,582
|
|
|
—
|
|
|||
Weighted-average shares of common stock outstanding used in the calculation of diluted net income per share attributable to Gilead common stockholders
|
|
1,694,747
|
|
|
1,582,549
|
|
|
1,580,236
|
|
|||
Net income per share attributable to Gilead common stockholders—basic
|
|
$
|
2.01
|
|
|
$
|
1.71
|
|
|
$
|
1.81
|
|
Net income per share attributable to Gilead common stockholders—diluted
|
|
$
|
1.81
|
|
|
$
|
1.64
|
|
|
$
|
1.77
|
|
15.
|
SEGMENT INFORMATION
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2013
|
|
2012
|
|
2011
|
||||||
Antiviral products:
|
|
|
|
|
|
|
||||||
Atripla
|
|
$
|
3,648,496
|
|
|
$
|
3,574,483
|
|
|
$
|
3,224,518
|
|
Truvada
|
|
3,135,771
|
|
|
3,181,110
|
|
|
2,875,141
|
|
|||
Viread
|
|
958,969
|
|
|
848,697
|
|
|
737,867
|
|
|||
Complera/Eviplera
|
|
809,452
|
|
|
342,200
|
|
|
38,747
|
|
|||
Stribild
|
|
539,256
|
|
|
57,536
|
|
|
—
|
|
|||
Sovaldi
|
|
139,435
|
|
|
—
|
|
|
—
|
|
|||
Hepsera
|
|
81,095
|
|
|
108,315
|
|
|
144,679
|
|
|||
Emtriva
|
|
27,405
|
|
|
29,449
|
|
|
28,764
|
|
|||
Total antiviral products
|
|
9,339,879
|
|
|
8,141,790
|
|
|
7,049,716
|
|
|||
Letairis
|
|
519,966
|
|
|
410,054
|
|
|
293,426
|
|
|||
Ranexa
|
|
448,624
|
|
|
372,949
|
|
|
320,004
|
|
|||
AmBisome
|
|
351,827
|
|
|
346,646
|
|
|
330,156
|
|
|||
Other products
|
|
143,399
|
|
|
126,932
|
|
|
109,057
|
|
|||
Total product sales
|
|
$
|
10,803,695
|
|
|
$
|
9,398,371
|
|
|
$
|
8,102,359
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2013
|
|
2012
|
|
2011
|
||||||
Revenues:
|
|
|
|
|
|
|
||||||
United States
|
|
$
|
6,695,178
|
|
|
$
|
5,591,988
|
|
|
$
|
4,608,343
|
|
Europe
|
|
3,613,414
|
|
|
3,332,824
|
|
|
3,124,699
|
|
|||
Other countries
|
|
893,096
|
|
|
777,705
|
|
|
652,343
|
|
|||
Total revenues
|
|
$
|
11,201,688
|
|
|
$
|
9,702,517
|
|
|
$
|
8,385,385
|
|
|
|
Year Ended December 31,
|
|||||||
|
|
2013
|
|
2012
|
|
2011
|
|||
Cardinal Health, Inc.
|
|
17
|
%
|
|
19
|
%
|
|
17
|
%
|
McKesson Corp.
|
|
16
|
%
|
|
16
|
%
|
|
14
|
%
|
AmerisourceBergen Corp.
|
|
13
|
%
|
|
11
|
%
|
|
12
|
%
|
16.
|
INCOME TAXES
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2013
|
|
2012
|
|
2011
|
||||||
Federal:
|
|
|
|
|
|
|
||||||
Current
|
|
$
|
1,156,124
|
|
|
$
|
1,002,946
|
|
|
$
|
704,412
|
|
Deferred
|
|
(71,428
|
)
|
|
(25,261
|
)
|
|
68,391
|
|
|||
|
|
1,084,696
|
|
|
977,685
|
|
|
772,803
|
|
|||
State:
|
|
|
|
|
|
|
|
|
|
|||
Current
|
|
62,643
|
|
|
49,503
|
|
|
62,631
|
|
|||
Deferred
|
|
(22,149
|
)
|
|
(15,242
|
)
|
|
(17,450
|
)
|
|||
|
|
40,494
|
|
|
34,261
|
|
|
45,181
|
|
|||
Foreign:
|
|
|
|
|
|
|
|
|
|
|||
Current
|
|
45,540
|
|
|
28,621
|
|
|
39,921
|
|
|||
Deferred
|
|
(19,797
|
)
|
|
(2,186
|
)
|
|
4,040
|
|
|||
|
|
25,743
|
|
|
26,435
|
|
|
43,961
|
|
|||
Provision for income taxes
|
|
$
|
1,150,933
|
|
|
$
|
1,038,381
|
|
|
$
|
861,945
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2013
|
|
2012
|
|
2011
|
||||||
Income before provision for income taxes
|
|
$
|
4,208,219
|
|
|
$
|
3,611,980
|
|
|
$
|
3,651,004
|
|
Tax at federal statutory rate
|
|
$
|
1,472,877
|
|
|
$
|
1,264,193
|
|
|
$
|
1,277,852
|
|
State taxes, net of federal benefit
|
|
22,164
|
|
|
16,551
|
|
|
27,894
|
|
|||
Foreign earnings at different rates
|
|
(279,288
|
)
|
|
(307,281
|
)
|
|
(443,879
|
)
|
|||
Research and other credits
|
|
(126,446
|
)
|
|
(16,126
|
)
|
|
(32,403
|
)
|
|||
Net unbenefitted stock compensation
|
|
24,676
|
|
|
11,292
|
|
|
14,860
|
|
|||
Non-deductible pharmaceutical excise tax
|
|
33,482
|
|
|
25,809
|
|
|
13,874
|
|
|||
Other
|
|
3,468
|
|
|
43,943
|
|
|
3,747
|
|
|||
Provision for income taxes
|
|
$
|
1,150,933
|
|
|
$
|
1,038,381
|
|
|
$
|
861,945
|
|
|
|
December 31,
|
||||||
|
|
2013
|
|
2012
|
||||
Deferred tax assets:
|
|
|
|
|
||||
Net operating loss carryforwards
|
|
$
|
227,498
|
|
|
$
|
225,652
|
|
Stock-based compensation
|
|
149,122
|
|
|
148,833
|
|
||
Reserves and accruals not currently deductible
|
|
256,370
|
|
|
186,601
|
|
||
Deferred revenue
|
|
42,390
|
|
|
39,904
|
|
||
Depreciation related
|
|
51,317
|
|
|
50,074
|
|
||
Research and other credit carryforwards
|
|
55,754
|
|
|
39,445
|
|
||
Other, net
|
|
37,939
|
|
|
48,428
|
|
||
Total deferred tax assets before valuation allowance
|
|
820,390
|
|
|
738,937
|
|
||
Valuation allowance
|
|
(8,931
|
)
|
|
(9,488
|
)
|
||
Total deferred tax assets
|
|
811,459
|
|
|
729,449
|
|
||
Deferred tax liabilities:
|
|
|
|
|
|
|
||
Intangibles
|
|
(368,115
|
)
|
|
(306,354
|
)
|
||
Unremitted foreign earnings
|
|
(15,928
|
)
|
|
(15,928
|
)
|
||
Other
|
|
(25,581
|
)
|
|
(23,669
|
)
|
||
Total deferred tax liabilities
|
|
(409,624
|
)
|
|
(345,951
|
)
|
||
Net deferred tax assets
|
|
$
|
401,835
|
|
|
$
|
383,498
|
|
|
|
December 31,
|
||||||||||
|
|
2013
|
|
2012
|
|
2011
|
||||||
Balance, beginning of period
|
|
$
|
156,997
|
|
|
$
|
146,908
|
|
|
$
|
126,516
|
|
Tax positions related to current year:
|
|
|
|
|
|
|
|
|
|
|||
Additions
|
|
112,205
|
|
|
26,691
|
|
|
21,113
|
|
|||
Reductions
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Tax positions related to prior years:
|
|
|
|
|
|
|
|
|
|
|||
Additions
|
|
13,263
|
|
|
1,609
|
|
|
11,171
|
|
|||
Reductions
|
|
(499
|
)
|
|
(12,866
|
)
|
|
(4,896
|
)
|
|||
Settlements
|
|
(38,839
|
)
|
|
—
|
|
|
(3,067
|
)
|
|||
Lapse of statute of limitations
|
|
(6,599
|
)
|
|
(5,345
|
)
|
|
(3,929
|
)
|
|||
Balance, end of period
|
|
$
|
236,528
|
|
|
$
|
156,997
|
|
|
$
|
146,908
|
|
17.
|
DEFERRED COMPENSATION PLANS
|
18.
|
QUARTERLY RESULTS OF OPERATIONS (UNAUDITED)
|
|
|
1st Quarter
|
|
2nd Quarter
|
|
3rd Quarter
|
|
4th Quarter
|
||||||||
2013
|
|
|
|
|
|
|
|
|
||||||||
Total revenues
|
|
$
|
2,531,635
|
|
|
$
|
2,767,394
|
|
|
$
|
2,782,833
|
|
|
$
|
3,119,826
|
|
Gross profit on product sales
|
|
$
|
1,759,120
|
|
|
$
|
1,972,622
|
|
|
$
|
2,027,784
|
|
|
$
|
2,185,667
|
|
Net income
|
|
$
|
717,710
|
|
|
$
|
767,618
|
|
|
$
|
785,216
|
|
|
$
|
786,742
|
|
Net income attributable to Gilead
|
|
$
|
722,186
|
|
|
$
|
772,605
|
|
|
$
|
788,606
|
|
|
$
|
791,411
|
|
Net income per share attributable to Gilead common stockholders-basic
|
|
$
|
0.47
|
|
|
$
|
0.51
|
|
|
$
|
0.51
|
|
|
$
|
0.52
|
|
Net income per share attributable to Gilead common stockholders-diluted
|
|
$
|
0.43
|
|
|
$
|
0.46
|
|
|
$
|
0.47
|
|
|
$
|
0.47
|
|
2012
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Total revenues
|
|
$
|
2,282,449
|
|
|
$
|
2,405,186
|
|
|
$
|
2,426,597
|
|
|
$
|
2,588,285
|
|
Gross profit on product sales
|
|
$
|
1,627,411
|
|
|
$
|
1,703,895
|
|
|
$
|
1,760,709
|
|
|
$
|
1,834,993
|
|
Net income
|
|
$
|
437,531
|
|
|
$
|
706,074
|
|
|
$
|
671,035
|
|
|
$
|
758,959
|
|
Net income attributable to Gilead
|
|
$
|
441,956
|
|
|
$
|
711,564
|
|
|
$
|
675,505
|
|
|
$
|
762,541
|
|
Net income per share attributable to Gilead common stockholders-basic
|
|
$
|
0.29
|
|
|
$
|
0.47
|
|
|
$
|
0.45
|
|
|
$
|
0.50
|
|
Net income per share attributable to Gilead common stockholders-diluted
|
|
$
|
0.28
|
|
|
$
|
0.46
|
|
|
$
|
0.43
|
|
|
$
|
0.47
|
|
|
|
Balance at Beginning of Period
|
|
Additions/Charged to Expense
|
|
Deductions
|
|
Balance at End of Period
|
||||
Year ended December 31, 2013:
|
|
|
|
|
|
|
|
|
||||
Accounts receivable allowances
(1)
|
|
261,013
|
|
|
1,891,478
|
|
|
1,818,184
|
|
|
334,307
|
|
Valuation allowances for deferred tax assets
(2)
|
|
9,488
|
|
|
72
|
|
|
629
|
|
|
8,931
|
|
Year ended December 31, 2012:
|
|
|
|
|
|
|
|
|
||||
Accounts receivable allowances
(1)
|
|
205,990
|
|
|
1,409,661
|
|
|
1,354,638
|
|
|
261,013
|
|
Valuation allowances for deferred tax assets
(2)
|
|
9,209
|
|
|
702
|
|
|
423
|
|
|
9,488
|
|
Year ended December 31, 2011:
|
|
|
|
|
|
|
|
|
||||
Accounts receivable allowances
(1)
|
|
150,942
|
|
|
1,228,006
|
|
|
1,172,958
|
|
|
205,990
|
|
Valuation allowances for deferred tax assets
(2)
|
|
13,040
|
|
|
436
|
|
|
4,267
|
|
|
9,209
|
|
|
(1)
|
Allowances are for doubtful accounts, sales returns, cash discounts and government chargebacks.
|
(2)
|
Valuation allowance for deferred tax assets includes $6.8 million and $7.2 million as of December 31, 2013 and 2012, respectively, related to our acquisitions.
|
G
ILEAD
S
CIENCES
, I
NC
.
|
|
|
|
By:
|
/
S
/ J
OHN
C. M
ARTIN
|
|
John C. Martin, Ph.D.
Chairman and Chief Executive Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/
S
/ J
OHN
C. M
ARTIN
|
|
Chairman and Chief Executive Officer
|
|
February 25, 2014
|
John C. Martin, Ph.D.
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/
S
/ R
OBIN
L. W
ASHINGTON
|
|
Executive Vice President and Chief Financial Officer
|
|
February 25, 2014
|
Robin L. Washington
|
|
(Principal Financial and Accounting Officer)
|
|
|
|
|
|
|
|
/
S
/ J
OHN
F. C
OGAN
|
|
Director
|
|
February 25, 2014
|
John F. Cogan
|
|
|
|
|
|
|
|
|
|
/
S
/ E
TIENNE
F. D
AVIGNON
|
|
Director
|
|
February 25, 2014
|
Etienne F. Davignon
|
|
|
|
|
|
|
|
|
|
/
S
/ C
ARLA
A. H
ILLS
|
|
Director
|
|
February 25, 2014
|
Carla A. Hills
|
|
|
|
|
|
|
|
|
|
/
S
/ K
EVIN
E. L
OFTON
|
|
Director
|
|
February 25, 2014
|
Kevin E. Lofton
|
|
|
|
|
|
|
|
|
|
/
S
/ J
OHN
W. M
ADIGAN
|
|
Director
|
|
February 25, 2014
|
John W. Madigan
|
|
|
|
|
|
|
|
|
|
/
S
/ N
ICHOLAS
G. M
OORE
|
|
Director
|
|
February 25, 2014
|
Nicholas G. Moore
|
|
|
|
|
|
|
|
|
|
/
S
/ R
ICHARD
J. W
HITLEY
|
|
Director
|
|
February 25, 2014
|
Richard J. Whitley
|
|
|
|
|
|
|
|
|
|
/
S
/ G
AYLE
E. W
ILSON
|
|
Director
|
|
February 25, 2014
|
Gayle E. Wilson
|
|
|
|
|
|
|
|
|
|
/
S
/ P
ER
W
OLD
-O
LSEN
|
|
Director
|
|
February 25, 2014
|
Per Wold-Olsen
|
|
|
|
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
---|---|---|---|
GEODE CAPITAL MANAGEMENT, LLC | 1,848,591 | 64,417,558 | |
GAMCO INVESTORS, INC. ET AL | 1,188,305 | 41,400,546 | |
GABELLI FUNDS LLC | 594,200 | 20,701,928 | |
GREAT LAKES ADVISORS, LLC | 261,016 | 9,093,797 | |
Parametric Portfolio Associates LLC | 250,146 | 8,595 | |
NEW YORK STATE TEACHERS RETIREMENT SYSTEM | 99,740 | 3,475 | |
CALIFORNIA STATE TEACHERS RETIREMENT SYSTEM | 77,406 | 2,696,825 | |
BNP PARIBAS FINANCIAL MARKETS | 73,179 | 2,549,556 | |
MetLife Investment Management, LLC | 47,145 | 1,642,532 | |
Jackson Creek Investment Advisors LLC | 41,490 | 1,446 | |
YOUSIF CAPITAL MANAGEMENT, LLC | 32,055 | 1,116,796 | |
PUBLIC EMPLOYEES RETIREMENT SYSTEM OF OHIO | 29,705 | 1,034,922 | |
NISA INVESTMENT ADVISORS, LLC | 25,500 | 888,420 | |
NEW YORK STATE COMMON RETIREMENT FUND | 25,285 | 881 | |
OREGON PUBLIC EMPLOYEES RETIREMENT FUND | 19,368 | 674,781 | |
AMUNDI | 14,515 | 496,848 | |
Brevan Howard Capital Management LP | 14,458 | 503,717 | |
Quantbot Technologies LP | 8,411 | 293,039 | |
RAYMOND JAMES TRUST N.A. | 7,997 | 278,617 | |
Russell Investments Group, Ltd. | 7,807 | 271,995 | |
Janney Montgomery Scott LLC | 7,675 | 267 | |
Ramirez Asset Management, Inc. | 1,300 | 45,292 | |
CIBC Private Wealth Group LLC | 847 | 29,515 | |
Catalyst Funds Management Pty Ltd | 800 | 27,872 | |
STRS OHIO | 600 | 20,904 | |
HARBOR CAPITAL ADVISORS, INC. | 390 | 14 | |
BARROW HANLEY MEWHINNEY & STRAUSS LLC | 367 | 12,786 | |
MASSMUTUAL TRUST CO FSB/ADV | 268 | 9,337 | |
UMB Bank, n.a. | 200 | 6,968 | |
PRIVATE TRUST CO NA | 145 | 5,052 | |
Oakworth Capital, Inc. | 131 | 4,564 | |
Sterling Capital Management LLC | 98 | 3,414 | |
FARMERS & MERCHANTS INVESTMENTS INC | 55 | 1,916 | |
Covestor Ltd | 51 | 2 |
DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
---|---|---|---|
MR. AINSWORTH is a member of the Finance Committee and the Governance Committee. From 2019 until his retirement in 2020, Mr. Ainsworth served as Group President of the Energy & Transportation segment for Caterpillar, Inc. (“Caterpillar”), a manufacturer of construction and mining equipment, diesel and natural gas engines, industrial gas turbines, and diesel-electric locomotives. From 2017 until his appointment as Group President in 2019, Mr. Ainsworth was Senior Vice President and Strategic Advisor to Caterpillar’s executive committee and was responsible for Caterpillar’s Rail Division. From 1993 until 2019, he served as President and Chief Executive Officer of Progress Rail Services, an integrated and diversified supplier of railroad and transit products and services as well as railcar leasing. Progress Rail Services was acquired by Caterpillar in 2006, and Mr. Ainsworth was appointed a Vice President of Caterpillar at that time. | |||
MS. LAKKUNDI is a member of the Audit Committee and the Governance Committee. She has served as Senior Vice President, Strategy & Corporate Development, of Rockwell Automation, Inc., an industrial automation and digital transformation company (“Rockwell”), since 2021. She joined Rockwell following a 28-year career with 3M Company, a consumer goods, health care, and worker safety company (“3M”). From 2020 to 2021, Ms. Lakkundi served as 3M’s Senior Vice President, Strategy & Business Development. From 2019 to 2020, she served as Global Vice President and General Manager, Industries Adhesives and Tapes Division. From 2017 to 2019, she served as Vice President, Chief Ethics & Compliance Officer. During her time with 3M, she held various other roles of increasing responsibility and seniority in profit and loss leadership, business development in emerging markets, and research and development. She currently serves on the board of Claroty, which empowers organizations to secure cyber-physical systems across industrial (OT), healthcare (IoMT), and enterprise (IoT) environments: the Extended Internet of Things (XIoT). She also serves on the Rockwell Automation Charitable Contributions board. She previously served on the board of the 3M Foundation. | |||
MR. MACLIN is Chair of the Finance Committee and a member of the HR Committee. Mr. Maclin retired in 2016 from a 37-year career at JPMorgan Chase & Co. and its predecessor banks, where he rose to Chairman, Chase Commercial and Consumer Banking in 2013, and served on the company's operating committee. Prior to that, he held a variety of leadership roles, including Regional Executive for Texas and the Southwest U.S., and Global Executive for Energy Investment Banking. Mr. Maclin serves as a director of The University of Texas Development Board, as a member of the advisory council for McCombs Graduate School of Business, on the executive committee of The University of Texas Chancellor's Council, on the board of visitors of UT Southwestern Health System, on the steering committee for the O'Donnell Brain Institute for UT Southwestern, and on the board of Southwestern Medical Foundation and a member of its investment committee. Mr. Maclin serves on the board of directors of Kimberly-Clark Corporation, a global manufacturer of branded tissue and personal care products. He also serves on the board of directors of RRH Corporation, the parent company of Hunt Consolidated, Inc., a company involved in oil and gas exploration and production, refining, liquified natural gas, power, real estate, investments, ranching, and infrastructure; is a board advisor for Cyber Defense Labs; and is a member of the SMU Tate Lecture Series board. | |||
The Board of Directors currently consists of eight members, all of which are standing for election at the Annual Meeting. Following a recommendation from the Governance Committee: Leldon E. Echols, Chairman of the Board William P. Ainsworth Robert C. Biesterfeld Jr. John J. Diez Veena M. Lakkundi S. Todd Maclin E. Jean Savage Dunia A. Shive have been nominated by the Board for election at the Annual Meeting to hold office until the next Annual Meeting or the election of their respective successors. Each of them is a current member of the Board. The Board of Directors has determined that all of the director nominees other than Ms. Savage, the Company's CEO, are “independent directors.” Therefore, the Board has concluded that Ms. Savage is not independent. An incumbent director nominee who receives a greater number of votes “against” than “for” in an uncontested election is required to tender his or her resignation for consideration by the Governance Committee and the Board (with the affected director recusing himself or herself from the deliberations). The Board will be free to accept or reject the resignation and will make its decision known publicly within 90 days of certification of the vote results. If a director’s resignation is accepted by the Board, the Board may fill the resulting vacancy. The information provided below is biographical information about each of the nominees, as well as a description of the experience, qualifications, attributes, or skills that led the Board to nominate the individual for election as a director of the Company. | |||
MR. ECHOLS serves as non-executive Chairman of the Board, Chair of the HR Committee, and a member of the Audit Committee, the Governance Committee, and the Finance Committee. He served as Executive Vice President and Chief Financial Officer of Centex Corporation, a residential construction company, from 2000 to 2006, when he retired. Prior to joining Centex, he spent 22 years with Arthur Andersen LLP and served as Managing Partner, Audit Practice for the North Texas, Colorado, and Oklahoma Region from 1997 to 2000. Mr. Echols is a member of the American Institute of Certified Public Accountants and the Texas Society of CPAs (inactive). Mr. Echols has been engaged in private investments since 2006. He is a member of the board of directors and Chair of the audit committee of EnLink Midstream Manager, LLC, a company that owns interests in EnLink Midstream, LLC, which is engaged in the gathering, transmission, treating, processing, and marketing of natural gas, natural gas liquids, and crude oil. He is also a member of the board of directors of HF Sinclair Corporation, an independent energy company. He served as a member of the board of directors of HollyFrontier Corporation, an independent petroleum refiner, from 2009 until the establishment of HF Sinclair Corporation as its parent company in 2022. From 2008 to 2014, Mr. Echols served on the boards of directors of Crosstex Energy, L.P. and Crosstex Energy, Inc., which are predecessors to certain of the EnLink entities. From 2014 to 2019, he was a member of the board of directors of EnLink Midstream GP, LLC, a company that owned interests in EnLink Midstream Partners, LP. | |||
MR. DIEZ is Chair of the Governance Committee and a member of the Audit Committee and the HR Committee. Since 2021, Mr. Diez has served as Executive Vice President and Chief Financial Officer of Ryder System, Inc. ("Ryder"), a commercial fleet management and supply chain solutions company. From 2019 to 2021, Mr. Diez served as the President of Fleet Management Solutions for Ryder. From 2015 to 2019, he was President of Dedicated Transportation Solutions for Ryder. Mr. Diez joined Ryder in 2002 and held various other roles of increasing responsibility and seniority in finance and operations. Mr. Diez spent eight years in the audit practice of KPMG LLP prior to joining Ryder. He is a Certified Public Accountant in the state of Florida and a former member of the American Institute of CPAs. He also serves on the board of directors of the U.S. Chamber of Commerce. | |||
MS. SHIVE is Chair of the Audit Committee and a member of the Governance Committee and the Finance Committee. From 2008 to 2013, she served as Chief Executive Officer and President of Belo Corp., a media company that owned several television stations, until its acquisition by Gannett Co., Inc. After the acquisition, Ms. Shive served as Senior Vice President of TEGNA Inc., formerly Gannett Co., Inc., a publishing, broadcast and digital media company, until her retirement in 2017. She joined Belo Corp. in 1993 and served in a variety of leadership positions during her tenure, including Chief Financial Officer. Ms. Shive is a member of the board of directors of Kimberly-Clark Corporation, a global manufacturer of branded tissue and personal care products, where she serves as Chair of the audit committee. Ms. Shive is also a member of the board of directors of Main Street Capital Corporation, a principal investment firm that provides long-term debt and equity capital to lower middle market companies and debt capital to middle market companies, and DallasNews Corporation, a local news and information publishing company in Texas. From 2014 to 2018, Ms. Shive was a director of Dr Pepper Snapple Group, Inc. From 2009 to 2015, she served on the board of directors of the Associated Press, where she served as Chair of the audit committee from 2011 to 2015. From 2008 to 2013, she served on the board of directors of Belo Corp. |
Name and Principal Position | Year |
Salary
($)
|
Stock Awards
($)
|
Non-Equity Incentive Plan Compensation
($)
|
Change in Pension Value and Nonqualified Deferred Compensation Earnings
($)
|
All Other Compensation
($)
|
Total
($) |
|||||||||||||||||||||||||
E. Jean Savage
Chief Executive Officer and President
|
2023 | 930,000 | 4,029,560 | 655,200 | 14,924 | 99,872 | 5,729,556 | |||||||||||||||||||||||||
2022 | 900,000 | 3,765,420 | 804,195 | 1,225 | 22,500 | 5,493,340 | ||||||||||||||||||||||||||
2021 | 850,000 | 3,613,344 | 1,064,413 | 3,580 | 47,860 | 5,579,197 | ||||||||||||||||||||||||||
Eric R. Marchetto
Executive Vice President and Chief Financial Officer
|
2023 | 596,225 | 1,079,661 | 228,600 | 11,179 | 21,019 | 1,936,684 | |||||||||||||||||||||||||
2022 | 578,860 | 1,025,053 | 357,750 | 1,154 | 22,636 | 1,985,453 | ||||||||||||||||||||||||||
2021 | 562,000 | 1,035,504 | 563,512 | 2,658 | 36,847 | 2,200,521 | ||||||||||||||||||||||||||
Gregory B. Mitchell
Executive Vice President, Leasing and Services
|
2023 | 515,000 | 757,285 | 255,960 | — | 28,979 | 1,557,224 | |||||||||||||||||||||||||
2022 | 458,758 | 697,517 | 242,475 | — | 35,535 | 1,434,285 | ||||||||||||||||||||||||||
2021 | 405,000 | 404,485 | 268,750 | — | 17,400 | 1,095,635 | ||||||||||||||||||||||||||
Kevin Poet
Executive Vice President, Operations and Support Services
|
2023 | 515,000 | 757,285 | 252,360 | — | 32,670 | 1,557,315 | |||||||||||||||||||||||||
2022 | 455,667 | 523,128 | 249,287 | — | 18,300 | 1,246,382 | ||||||||||||||||||||||||||
2021 | 361,987 | 469,687 | 266,103 | — | 89,099 | 1,186,876 | ||||||||||||||||||||||||||
Steven L. McDowell
Vice President and Chief Audit Executive
|
2023 | 413,750 | 227,202 | 111,755 | — | 18,619 | 771,326 | |||||||||||||||||||||||||
Sarah R. Teachout
Former Executive Vice President and Chief Legal Officer
|
2023 | 332,491 | 811,343 | — | 5,625 | 19,800 | 1,169,259 | |||||||||||||||||||||||||
2022 | 463,500 | 783,723 | 254,400 | 880 | 36,048 | 1,538,551 | ||||||||||||||||||||||||||
2021 | 450,000 | 722,686 | 400,720 | 2,033 | 22,591 | 1,598,030 |
No Suppliers Found
Price
Yield
Owner | Position | Direct Shares | Indirect Shares |
---|---|---|---|
Marchetto Eric R | EVP & CFO | 250,402 | 2,813 |
Marchetto Eric R | Director | 224,888 | 2,843 |
Savage Jean | President & CEO | 194,176 | 0 |
Savage Jean | Director | 156,402 | 249,606 |
Mitchell Gregory B | EVP & Chief Commercial Officer | 127,714 | 0 |
Mitchell Gregory B | Director | 121,165 | 0 |
McDowell Steven L | VP & Chief Acctg Officer | 73,177 | 0 |
Poet Kevin | EVP Operations & Support Svcs | 36,718 | 0 |
Poet Kevin | Director | 28,422 | 0 |
MACLIN TODD | Director | 27,548 | 0 |
Biesterfeld Robert C Jr | Director | 0 | 35 |