FOSTER CITY - Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the third quarter 2020.
'The recent acquisition of Immunomedics has effectively transformed Gilead's growth story. Building on the foundation of our strong core business, which proved its durability once again this quarter, we have now significant opportunity to drive additional growth at an accelerated pace,' said Daniel O'Day, Chairman and Chief Executive Officer, Gilead Sciences. 'Trodelvy, an approved medicine with extensive potential for patients with a range of tumor types, adds to our growing portfolio of transformational medicines. By following the strategy we laid out at the start of this year, we have significantly improved Gilead's near and long-term growth potential.'
Total revenues for the third quarter 2020 were $6.6 billion, up 17%, compared to $5.6 billion, for the same period in 2019.
Product sales, excluding Veklury (remdesivir), increased 2% year-over-year to $5.6 billion for the third quarter 2020 primarily due to Gilead's core HIV products driven by higher volume as channel inventory continues to normalize in the United States as well as stronger patient demand. The increase was partially offset by lower sales volume of Truvada (emtricitabine ('FTC') and tenofovir disoproxil fumarate ('TDF'))-based products and lower sales of hepatitis C virus ('HCV') products.
Veklury revenues were $873 million for the third quarter 2020.
GAAP net income and diluted earnings per share for the third quarter 2020 were $360 million and $0.29, respectively, compared to net loss and diluted loss per share of $(1.2) billion and $(0.92), respectively, for the same period in 2019.
GAAP results for the third quarter 2020 included acquired in-process research and development ('IPR&D') charges totaling $1.2 billion related to collaborations and other investments Gilead entered into during the current quarter as well as a $923 million unrealized loss from changes in the fair value of Gilead's equity investments in Galapagos NV ('Galapagos').
GAAP results for the third quarter 2019 included $4.0 billion acquired IPR&D charges primarily related to Gilead's global research and development collaboration agreement with Galapagos.
Non-GAAP net income and diluted EPS for the third quarter 2020 were $2.7 billion and $2.11, respectively, compared to $2.1 billion and $1.64, respectively, for the same period in 2019.
As expected, the third quarter 2020 revenues reflect the continued impact from the COVID-19 pandemic on HCV and pre-exposure prophylaxis ('PrEP'). However, Gilead continued to see signs of recovery in Europe and the United States during the third quarter 2020.
Total product sales increased 18% to $6.5 billion for the third quarter 2020, compared to $5.5 billion for the same period in 2019, primarily due to sales of Veklury and Gilead's core HIV products driven by higher volume and stronger patient demand.
For the third quarter 2020, product sales in the United States, Europe and other international locations were $5.1 billion, $877 million and $540 million, respectively. For the third quarter 2019, product sales in the United States, Europe and other international locations were $4.2 billion, $804 million and $513 million, respectively.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
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: the risks and uncertainties related to the impact of the COVID-19 pandemic on Gilead's business, financial condition and results of operations; the risks and uncertainties related to the development, manufacturing and distribution of remdesivir as a treatment for COVID-19, including the uncertainty of the amount and timing of future Veklury revenues and the risk that Gilead may be unable to recoup the expenses incurred to date and future expenses related to the development and production of remdesivir, Gilead may be unable to maintain the production of remdesivir at current and anticipated levels and Gilead may be unable to effectively manage the global supply and distribution of remdesivir; Gilead's ability to achieve its anticipated full year 2020 financial results, including as a result of potential adverse revenue impacts from COVID-19, increases in expenses due to the development and commercialization of remdesivir and potential revenues from Veklury; Gilead's ability to make progress on any of its long-term ambitions laid out in its corporate strategy; Gilead's ability to accelerate or sustain revenues for its antiviral and other programs; Gilead's ability to realize the potential benefits of acquisitions, collaborations or licensing arrangements, including those of or with Arcus, HiFiBiO, Immunomedics, Jounce, Pionyr, Tango and Tizona; the ability to initiate, progress or complete clinical trials within currently anticipated timeframes, including the ongoing and additional clinical trials involving remdesivir for the treatment of COVID-19; the possibility of unfavorable results from ongoing and additional clinical trials involving Biktarvy, Epclusa, Descovy for PrEP, Trodelvy, Truvada for PrEP, Veklury and Vemlidy; the risk that safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including filgotinib, lenacapavir, KTE-X19, magrolimab, remdesivir, selgantolimod and vesatolimod, or the product candidates of Gilead's strategic partners; Gilead's ability to submit new drug applications for new product candidates in the currently anticipated timelines; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including FDA approval of Yescarta for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma after two or more prior lines of systemic therapy and EC approval of KTE-X19 for the treatment of relapsed or refractory mantle cell lymphoma, which may be subject to signification limitations on use; Gilead's ability to successfully commercialize its products; the risk of potential disruptions to the manufacturing and supply chain of Gilead's products; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products; the risk that efforts to control prescription drug prices could have a material adverse effect on Gilead's business; a larger than anticipated shift in payer mix to more highly discounted payer segments; market share and price erosion caused by the introduction of generic versions of Gilead products; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the 'SEC'). Additionally, with respect to Gilead's acquisition of Immunomedics, risks and uncertainties include: the uncertainties relating to the post-closing operations and outlook for the business, including, without limitation, Gilead's ability to advance the product pipeline and successfully commercialize Trodelvy expectations for achieving full FDA approval based on confirmatory data for Trodelvy and the development of Trodelvy for additional indications; difficulties or unanticipated expenses in connection with the integration of Immunomedics the effects of the transaction on relationships with employees, other business partners or governmental entities Gilead's ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain requirements, and promotional and marketing compliance); imposition of significant post-approval regulatory requirements on products, including a requirement for a post-approval confirmatory clinical study, or failure to maintain (if received) or obtain full regulatory approval for products due to a failure to satisfy post-approval regulatory requirements, such as the submission of sufficient data from a confirmatory clinical study and other risks identified from time to time in the companies' reports filed with the SEC. In addition, Gilead makes estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. Gilead bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. There may be other factors of which Gilead is not currently aware that may affect matters discussed in the forward-looking statements and may also cause actual results to differ significantly from these estimates. Further, results for the quarter ended September 30, 2020 are not necessarily indicative of operating results for any future periods. Information about these and other risks, uncertainties and factors can be found in Gilead's periodic reports filed with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. Gilead claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements.
All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update or supplement any such forward-looking statements other than as required by law. Any forward-looking statements speak only as of the date hereof or as of the dates indicated in the statements.
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