Gilead Sciences second quarter total revenues increase 13% to $2.41 billion

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the quarter ended June 30, 2012. Total revenues for the second quarter of 2012 increased 13 percent to $2.41 billion, from $2.14 billion for the second quarter of 2011. Net income for the second quarter of 2012 was $711.6 million, or $0.91 per diluted share compared to $746.2 million, or $0.93 per diluted share for the second quarter of 2011. Non-GAAP net income for the second quarter of 2012, which excludes acquisition-related, restructuring and stock-based compensation expenses, was $767.3 million, or $0.99 per diluted share compared to $797.7 million, or $1.00 per diluted share for the second quarter of 2011.

Product Sales

Product sales increased 14 percent to $2.32 billion for the second quarter of 2012 compared to $2.04 billion for the second quarter of 2011. This increase in product sales was driven primarily by Gilead's antiviral franchise, resulting from increased sales of Atripla^® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), Truvada^® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) and Complera^®/Eviplera^® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg) which was launched in the U.S. in August 2011.

Antiviral Franchise

Antiviral product sales increased 14 percent to $2.01 billion for the second quarter of 2012, up from $1.76 billion for the second quarter of 2011, reflecting sales growth of 21 percent in the U.S. and 3 percent in Europe. In the U.S., antiviral product sales for the second quarter of 2012 reflect the benefit of purchases by certain state AIDS Drug Assistance Programs (ADAPs) in excess of demand.

• Atripla
  Sales of Atripla increased 10 percent to $904.0 million for the second quarter of 2012, up from $822.0 million for the second quarter of 2011, reflecting sales growth of 12 percent in the U.S. and 5 percent in Europe.

• Truvada
  Sales of Truvada increased 10 percent to $785.9 million for the second quarter of 2012, up from $711.3 million for the second quarter of 2011, reflecting sales growth of 18 percent in the U.S. and 2 percent in Europe.

• Viread
  Sales of Viread^® (tenofovir disoproxil fumarate) increased 16 percent to $215.4 million for the second quarter of 2012, up from $185.7 million for the second quarter of 2011, reflecting sales growth of 27 percent in the U.S. partially offset by a decrease of 2 percent in Europe.

• Complera/Eviplera
  Sales of Complera/Eviplera increased 40 percent to $72.9 million during the second quarter of 2012 from $52.2 million for the first quarter of 2012. Complera was approved in the U.S. in August 2011, and Eviplera was approved in the European Union in November 2011.

Letairis

Sales of Letairis^® (ambrisentan) increased 38 percent to $101.6 million for the second quarter of 2012, up from $73.6 million for the second quarter of 2011.

Ranexa

Sales of Ranexa^® (ranolazine) increased 11 percent to $95.6 million for the second quarter of 2012, up from $86.1 million for the second quarter of 2011.

Other Products

Sales of other products were $111.8 million for the second quarter of 2012 compared to $115.5 million for the second quarter of 2011 and included AmBisome^® (amphotericin B) liposome for injection and Cayston^® (aztreonam for inhalation solution).

Royalty, Contract and Other Revenues

Royalty, contract and other revenues were $83.9 million for the second quarter of 2012, down 14 percent from $97.7 million for the second quarter of 2011, due primarily to lower Tamiflu royalties from F. Hoffmann-La Roche Ltd., partially offset by an increase in other royalty revenues.

Research and Development

Research and development (R&D) expenses for the second quarter of 2012 were $396.2 million compared to $282.4 million for the second quarter of 2011. Non-GAAP R&D expenses for the second quarter of 2012, which exclude acquisition-related, restructuring and stock-based compensation expenses, were $371.4 million compared to $262.6 million for the second quarter of 2011. The increase in non-GAAP R&D expenses was due primarily to the continued advancement of Gilead's product pipeline, particularly in the liver disease and oncology franchises.

Selling, General and Administrative

Selling, general and administrative (SG&A) expenses in the second quarter of 2012 were $332.5 million compared to $304.3 million for the second quarter of 2011. Non-GAAP SG&A expenses for the second quarter of 2012, which exclude acquisition-related, restructuring and stock-based compensation expenses, were $298.7 million compared to $276.4 million for the second quarter of 2011. The increase in non-GAAP SG&A expenses was due primarily to increased expenses to support the ongoing growth of Gilead's business.

Interest Expense and Other Income (Expense), Net

Interest expense for the second quarter of 2012 was $88.4 million compared to $46.1 million for the second quarter of 2011. The increase was due primarily to the additional debt issued in connection with the acquisition of Pharmasset Inc. (Pharmasset) in the first quarter of 2012. Other income (expense), net for the second quarter of 2012 was a net expense of $1.1 million compared to net income of $12.0 million in the second quarter of 2011. The change was due primarily to decreased interest income from lower cash, cash equivalents and marketable securities.

Net Foreign Currency Exchange Impact

The net foreign currency exchange impact on second quarter 2012 product sales and pre-tax earnings was an unfavorable $31.7 million and $17.4 million, respectively, compared to the second quarter of 2011.

Cash, Cash Equivalents and Marketable Securities

As of June 30, 2012, Gilead had $2.27 billion of cash, cash equivalents and marketable securities compared to $9.96 billion as of December 31, 2011. The decrease was due to the acquisition of Pharmasset in the first quarter of 2012. Gilead generated $1.74 billion of operating cash flow during the first six months of 2012 including $1.29 billion generated in the second quarter of 2012 driven by the collection of $460 million of past due accounts receivable in Spain contributing to a 15 day reduction in days sales outstanding.

Corporate Highlights

Antiviral Franchise

In April, Gilead announced interim data from the Phase 2 ATOMIC study examining a 12-week course of treatment with the investigational once-daily nucleotide GS-7977 plus pegylated interferon and ribavirin (RBV) in treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection. The study found that 90 percent of patients achieved a 12-week sustained virologic response (SVR12), defined as maintaining undetectable viral load 12 weeks after the completion of therapy. These findings were presented at the 47^th Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain.

Also in April, Gilead announced interim data from the Phase 2 ELECTRON study examining GS-7977 plus RBV in treatment-naïve patients with genotype 1 chronic HCV infection. Of the 25 patients who completed 12 weeks of treatment, 88 percent achieved a four-week sustained virologic response (SVR4). Three patients experienced viral relapse. These findings were presented at EASL.

Lastly in April, Gilead announced interim results from the Phase 2 QUANTUM study examining a 12-week duration of GS-7977 plus RBV in treatment-naïve patients. Twenty-five patients were randomized to the 12-week treatment arm: 19 genotype 1 patients; four genotype 3 patients; and two genotype 2 patients. At the four-week post-treatment time period, data were available for 17 genotype 1 patients. Of these, 59 percent achieved SVR4 and 41 percent experienced viral relapse. Additionally, seven of the patients who reached the eight-week post-treatment time period, and who achieved SVR4, remained HCV RNA undetectable.

In May, Gilead announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted to support approval of once-daily oral Truvada to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis or PrEP. The Antiviral Drugs Advisory Committee also voted 13 to one in support of approval of Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-naïve adults.

Also in May, Gilead announced that the Marketing Authorisation Application (MAA) for cobicistat had been validated by the European Medicines Agency (EMA). Cobicistat is Gilead's pharmacoenhancing or "boosting" agent that increases blood levels of certain commercially available protease inhibitors, including atazanavir and darunavir, in order to enable once-daily dosing. In June, Gilead submitted a New Drug Application (NDA) to the FDA for marketing approval of cobicistat.

In June, Gilead announced that its NDA and MAA for elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced patients, had been submitted to the FDA and validated by the EMA, respectively. Elvitegravir, a component of Gilead's once-daily Quad single tablet regimen, is currently under U.S. and European regulatory review for treatment-naïve adult patients.

Oncology Franchise

In May, Gilead announced that the first patient had been dosed in a Phase 3 clinical trial evaluating the efficacy and safety of GS-1101 in combination with rituximab in previously treated chronic lymphocytic leukemia patients. GS-1101 is an investigational, first-in-class specific inhibitor of the phosphoinositide-3 kinase delta isoform.