On February 2, 2016 – Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the fourth quarter and full year 2015 (Filing, 8-K, Gilead Sciences, FEB 2, 2016, View Source [SID:1234508942]). Total revenues for the fourth quarter of 2015 were $8.5 billion compared to $7.3 billion for the fourth quarter of 2014. Net income for the fourth quarter of 2015 was $4.7 billion, or $3.18 per diluted share compared to $3.5 billion, or $2.18 per diluted share for the fourth quarter of 2014. Non-GAAP net income for the fourth quarter of 2015, which excludes amounts related to acquisition, stock-based compensation and other, was $4.9 billion, or $3.32 per diluted share compared to $3.9 billion, or $2.43 per diluted share for the fourth quarter of 2014.

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Full year 2015 total revenues were $32.6 billion compared to $24.9 billion for 2014. Net income for 2015 was $18.1 billion, or $11.91 per diluted share compared to $12.1 billion, or $7.35 per diluted share for 2014. Non-GAAP net income for 2015, which excludes amounts related to acquisition, stock-based compensation and other, was $19.2 billion, or $12.61 per diluted share compared to $13.3 billion, or $8.09 per diluted share for 2014.

Product Sales
Total product sales for the fourth quarter of 2015 were $8.4 billion compared to $7.2 billion for the fourth quarter of 2014. In the fourth quarter of 2015, product sales in the U.S. were $4.8 billion compared to $5.5 billion in the fourth quarter of 2014. In Europe, product sales were $1.7 billion compared to $1.4 billion in the fourth quarter of 2014. Sales in other international locations increased to $1.9 billion compared to $373 million in the fourth quarter of 2014, primarily due to sales of Sovaldi (sofosbuvir 400 mg) and Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) in Japan.

Total product sales during 2015 were $32.2 billion compared to $24.5 billion in 2014, primarily due to sales of Harvoni which was launched in October 2014, partially offset by a decrease in sales of Sovaldi. For 2015, product sales in the U.S. were $21.2 billion compared to $18.1 billion in 2014. In Europe, product sales were $7.2 billion compared to $5.1 billion in 2014. Sales in other international locations increased to $3.8 billion in 2015 compared to $1.2 billion in 2014, primarily due to sales of Sovaldi and Harvoni in Japan.

Antiviral Product Sales
Antiviral product sales, which include products in our HIV and liver diseases areas, were $7.9 billion for the fourth quarter of 2015 compared to $6.7 billion for the fourth quarter of 2014 primarily as a result of the launch of our HCV products in Japan and continued launches of our HCV products across Europe, partially offset by lower sales of HCV products in the U.S. For 2015, antiviral product sales were $30.2 billion compared to $22.8 billion in 2014 primarily due to sales of Harvoni, partially offset by a decrease in sales of Sovaldi.

Other Product Sales
Other product sales, which include Letairis, Ranexa and AmBisome, were $523 million for the fourth quarter of 2015 compared to $496 million for the fourth quarter of 2014. For 2015, other product sales were $1.9 billion compared to $1.7 billion in 2014.

• During the fourth quarter of 2015, non-GAAP R&D expenses decreased, compared to same period in 2014, primarily due to the 2014 impact of up-front fees paid in connection with Gilead’s collaboration with ONO Pharmaceutical Co., Ltd. (ONO) and the purchase of a U.S. Food and Drug Administration (FDA) priority review voucher, partially offset by increased costs to support the continued progression of Gilead’s clinical studies in 2015.

• During 2015, non-GAAP R&D expenses increased, compared to 2014, primarily due to the progression of Gilead’s clinical studies, partially offset by the 2014 impact of up-front fees paid in connection with Gilead’s collaboration with ONO and the purchase of a FDA priority review voucher.

• During the fourth quarter and full year 2015, non-GAAP SG&A expenses increased, compared to same periods in 2014, primarily to support Gilead’s growth and the geographic expansion of its business.

Cash, Cash Equivalents and Marketable Securities
As of December 31, 2015, Gilead had $26.2 billion of cash, cash equivalents and marketable securities compared to $11.7 billion as of December 31, 2014. During 2015, Gilead generated $20.3 billion in operating cash flow, utilized $10.0 billion to repurchase 95 million shares of its stock and paid cash dividends of $1.9 billion, or $1.29 per share.

Corporate Highlights

• Gilead was the top corporate HIV/AIDS philanthropic funder and the No. 2 private HIV/AIDS philanthropic funder overall behind the Bill & Melinda Gates Foundation, according to the Funders Concerned About AIDS Report issued on December 8, 2015. Gilead gave $73.4 million in HIV/AIDS philanthropic support in 2014. The company’s corporate giving helps address the HIV epidemic on all fronts, including testing and linkage to care, enabling access to medicines, reducing disparities in the quality of healthcare and educating healthcare professionals on the latest advances in HIV therapies.

• Gilead is partnering with the U.S. government, the Bill & Melinda Gates Foundation and other corporate donors on the DREAMS initiative aimed at reducing HIV infections among adolescent girls and young women in sub-Saharan Africa. Gilead will provide funding to help the program purchase generic Truvada for use as pre-exposure prophylaxis (PrEP) among HIV-negative adolescent girls and young women in sub-Saharan Africa, as well as to support costs related to procurement, transportation and dissemination of PrEP.

Product & Pipeline Updates Announced by Gilead During the Fourth Quarter of 2015 Include:

Antiviral Program

• Announced that the European Commission granted marketing authorization for the once-daily single tablet regimen Genvoya for the treatment of HIV-1 infection. Genvoya is the first tenofovir alafenamide (TAF)-based regimen to receive marketing authorization in the European Union (EU). Genvoya is indicated in the EU for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with HIV-1 without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.

• Announced that FDA approved Genvoya for the treatment of HIV-1 infection. Genvoya is the first TAF-based regimen to receive FDA approval. Genvoya is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA levels less than 50 copies per mL) on a stable antiretroviral regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Genvoya.

• Announced positive 96-week results from two Phase 3 studies evaluating Genvoya for the treatment of HIV-1 infection in treatment-naïve adults. Genvoya was found to be statistically non-inferior to Stribild, based on percentages of patients with HIV-1 RNA levels less than 50 copies/mL. Patients receiving Genvoya also had improved renal and bone laboratory parameters compared to those treated with Stribild. These data were presented at the 15th European AIDS Conference.

• Announced that the Marketing Authorization Application for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection, was fully validated and under assessment by the European Medicines Agency (EMA). The data included in the application support the use of SOF/VEL among patients with genotype 1-6 HCV infection, including patients with compensated and decompensated cirrhosis. SOF/VEL is the third investigational medicinal product from Gilead for HCV infection to receive accelerated review by the EMA.

• Announced that FDA approved Harvoni for expanded use in patients with genotype 4, 5 and 6 HCV infection and in patients co-infected with HIV. In addition, Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis.

• Announced that the company submitted a New Drug Application to FDA for an investigational, once-daily fixed-dose combination of SOF/VEL, for the treatment of chronic genotype 1-6 HCV infection. The NDA is supported by clinical studies exploring the use of 12 weeks of SOF/VEL for patients with genotype 1-6 HCV infection, including patients with compensated cirrhosis and 12 weeks of SOF/VEL with RBV for patients with decompensated cirrhosis. FDA assigned SOF/VEL with a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options.

• Announced that the company fulfilled a request for compassionate access to GS-5734, a novel nucleotide analogue in development for the potential treatment of Ebola Virus Disease. The compound was provided to two patients, one a female patient in the Royal Free Hospital in London in October and one in Guinea the following month, through a compassionate use request. Two Phase 1 human trials are now underway in healthy adult volunteers.

Oncology Program

• Announced positive results from a prespecified interim analysis of a Phase 3 study evaluating Zydelig in combination with bendamustine and rituximab (BR) for patients with previously treated chronic lymphocytic leukemia. The analysis found a 67 percent reduction in the risk of disease progression or death (progression-free survival) in patients receiving Zydelig plus BR compared to BR alone. Additionally, all secondary endpoints, including overall survival, achieved statistical significance in this interim analysis. These data were presented at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper).

Cardiovascular Program
• Announced that FDA approved the use of Letairis in combination with tadalafil for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.

Inflammation Program
• Announced that Gilead and Galapagos NV entered into a collaboration for the development and commercialization of the JAK1-selective inhibitor filgotinib for inflammatory disease indications. This collaboration represents an opportunity to add complementary clinical programs to our growing inflammation research and development efforts. Phase 2 trial data show that filgotinib has the potential to be an effective and well-tolerated oral therapy for patients with rheumatoid arthritis (RA) and Crohn’s disease. Phase 3 trials in RA and Crohn’s are expected to start in mid-2016 pending the successful outcome of discussions with regulatory authorities.