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|Gilead Sciences Announces First Quarter 2013 Financial Results|
- Product Sales of
- Total Revenues of
- Reiterates Full Year 2013 Guidance -
The increase in product sales during the first quarter of 2013 was due primarily to Gilead's antiviral franchise, resulting from increased sales of Complera®/Eviplera® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg) and the launch of Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in the third quarter of 2012.
Antiviral Product Sales
Antiviral product sales increased 7 percent to
Cardiovascular Product Sales
Cardiovascular product sales increased 26 percent to
Operating Expenses and Other
Non-GAAP research and development (R&D) expenses increased due to Gilead's continued investment in its product pipeline, particularly in liver disease and oncology. Non-GAAP selling, general and administrative (SG&A) expenses increased primarily due to expenses to support the ongoing growth of Gilead's business.
Interest expense decreased primarily due to the repayment of bank debt
issued in connection with the acquisition of
(1) Non-GAAP R&D expenses and SG&A expenses exclude the impact of acquisition-related, restructuring and stock-based compensation expenses where applicable.
Net Foreign Currency Exchange Impact
The net foreign currency exchange impact on first quarter 2013 product
sales and pre-tax earnings was an unfavorable
As of March 31, 2013, Gilead had
Full Year 2013 Guidance Reiterated
* Non-GAAP product gross margin, expense and effective tax rate exclude the impact of acquisition-related, restructuring and stock-based compensation expenses where applicable.
In February, Gilead announced the completion of its acquisition of YM, a publicly-held drug development company that was primarily focused on advancing its lead product candidate momelotinib (formally known as CYT387), an orally administered, once-daily, selective inhibitor of the Janus kinase (JAK) family. The acquisition of YM represents an opportunity to add a complementary clinical program in the area of hematologic cancers to our growing oncology portfolio.
Also in February, Gilead announced that it reached an agreement in
Product & Pipeline Update
In January, Gilead announced:
In February, Gilead announced:
In March, Gilead announced:
In March, Gilead announced data from the Phase 4 TERISA (Type 2 Diabetes Evaluation of Ranolazine In Subjects With Chronic Stable Angina) study, which demonstrated that the addition of ranolazine to background antianginal therapy in chronic angina patients with type 2 diabetes significantly reduced the frequency of weekly angina episodes compared to background antianginal therapy alone.
A replay of the webcast will be archived on the company's website for
one year, and a phone replay will be available approximately two hours
following the call through
Non-GAAP Financial Information
Gilead has presented certain financial information in accordance with U.S. generally accepted accounting principles (GAAP) and also on a non-GAAP basis. Management believes this non-GAAP information is useful for investors, taken in conjunction with Gilead's GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead's operating results as reported under GAAP. A reconciliation between GAAP and non-GAAP financial information is provided in the table on pages 8 and 9.
Statements included in this press release that are not historical in
nature are forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Gilead cautions readers that
forward-looking statements are subject to certain risks and
uncertainties that could cause actual results to differ materially.
These risks and uncertainties include: Gilead's ability to achieve its
anticipated full year 2013 financial results; Gilead's ability to
sustain growth in revenues for its antiviral, cardiovascular and
respiratory franchises; availability of funding for state AIDS Drug
Assistance Programs (ADAPs); continued fluctuations in ADAP purchases
driven by federal and state grant cycles which may not mirror patient
demand and may cause fluctuations in Gilead's earnings; the possibility
of unfavorable results from clinical trials involving sofosbuvir, the
fixed-dose combination of sofosbuvir/ledipasvir and single tablet
regimens containing TAF for the treatment of HIV-1 infection; the levels
of inventory held by wholesalers and retailers which may cause
fluctuations in Gilead's earnings; Gilead's ability to submit new drug
applications for new product candidates in the timelines currently
anticipated, including sofosbuvir and sofosbuvir/ledipasvir for the
treatment of HCV; Gilead's ability to receive regulatory approvals in a
timely manner or at all, for new and current products, including
Stribild from the
Gilead owns or has rights to various trademarks, copyrights and trade
names used in our business, including the following: GILEAD®,
Gilead Sciences, Inc.
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