SPY381.72-1.91 -0.50%
DIA318.25+3.01 0.95%
IXIC12,609.16-310.99 -2.41%

Press Release: Gilead Sciences Announces Fourth -4-

· 02/04/2021 16:01
Category Therapeutic Area and Description ------------------------------------ -------------------------------------- Regulatory Approval & Submission Oncology ------------------------------------ European Commission granted conditional marketing authorization for Tecartus for the treatment of adult patients with relapsed or refractory mantle cell lymphoma in December 2020. ------------------------------------ Gilead submitted a supplemental Biologics License Application to U.S. Food and Drug Administration ("FDA") for approval of Trodelvy as a treatment for adult patients with metastatic triple-negative breast cancer ("mTNBC") based on the overall efficacy and safety results in the Phase 3 ASCENT trial. Inflammatory Diseases European Medicines Agency ("EMA") validated and is reviewing the application of Gilead and Galapagos for a new indication to the approved license for filgotinib 200mg. The proposed indication is for the treatment of adults with moderately to severely active ulcerative colitis ("UC"). ------------------------------------ -------------------------------------- Clinical Trials & Data Presentations Viral Diseases Gilead presented results from the Phase 2/3 CAPELLA trial evaluating lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, in heavily treatment-experienced people with multidrug resistant HIV-1 infection. Oncology Gilead and Kite presented new data including results from:ZUMA-12 trial, a Phase 2 study evaluating Yescarta in patients with high-risk large B-cell lymphoma; ZUMA-5 trial, a Phase 2 study evaluating Yescarta in adult patients with relapsed or refractory indolent non-Hodgkin lymphoma; ZUMA-1 trial, a study evaluating Yescarta in adult patients with refractory LBCL; ZUMA-2 trial, a study evaluating Tecartus in adult patients with relapsed or refractory mantle cell lymphoma; and A Phase 1b trial evaluating magrolimab, in combination with azacitidine in previously untreated acute myeloid leukemia patients. Inflammatory Diseases Gilead and Novo Nordisk A/S presented results from a Phase 2 proof-of-concept trial evaluating combinations of Novo Nordisk's semaglutide with Gilead's investigational FXR agonist cilofexor and/or Gilead's investigational ACC inhibitor firsocostat in people with non-alcoholic steatohepatitis. Corporate Development Viral Diseases Gilead entered into a definitive agreement to acquire MYR GmbH for approximately EUR1.2 billion in cash payable upon closing of the transaction, plus a potential future milestone payment of up to EUR300 million.Upon closing, the acquisition will provide Gilead with Hepcludex(TM) (bulevirtide), which was conditionally approved by the EMA for the treatment for chronic hepatitis delta virus in July 2020. Gilead and Vir Biotechnology, Inc. established clinical collaboration related to hepatitis B virus(1) A reconciliation between GAAP and non-GAAP financial information for the 2021 guidance is provided in the table on page 15.(In millions, except percentages and per share amounts) February 4, 2021 ------------------------------------- ------------------------------------ Product sales excluding Veklury sales(1) $21,700 - $22,100 Veklury sales 2,000 - 3,000 ------------------------------------ Total product sales $23,700 - $25,100 ------------------------------------ Non-GAAP Product Gross Margin(1) 87% - 88% Flat to low single-digit percentage R&D Expenses decline Flat to low single-digit percentage SG&A Expenses decline Operating Income(1) $11,500 - $12,900 Effective Tax Rate(1) 21% Diluted EPS(1) $6.75 - $7.45 GAAP Diluted EPS $5.25 - $5.95

As of December 31, 2020, Gilead had $7.9 billion of cash, cash equivalents and marketable debt securities compared to $25.8 billion as of December 31, 2019. During 2020, Gilead generated $8.2 billion in operating cash flow, issued senior unsecured notes in an aggregate principal amount of $7.25 billion, borrowed an aggregate principal amount of $1.0 billion under a three-year term loan facility, utilized $25.7 billion on acquisitions, net of cash acquired (including IPR&D), repaid $2.5 billion of principal amount of debt, paid cash dividends of $3.4 billion and utilized $1.6 billion on share repurchases.

Gilead may choose to repay certain of its long-term debt obligations prior to maturity dates based on its assessment of current and long-term liquidity and capital requirements.

Full Year 2021 Guidance

Gilead is providing full year 2021 guidance below. Veklury sales are subject to significant volatility and uncertainty due to a highly dynamic and complex global health environment, which continues to evolve. As a result, Gilead believes providing its full year 2021 guidance excluding Veklury sales is useful for investors, when considered in conjunction with its GAAP financial information.


The financial guidance excludes the effects of any potential future strategic acquisitions, collaborations and investments, the exercise of opt-ins or options related to collaboration programs where Gilead has such rights with its collaboration partners, and any other transactions or items that have not yet been identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below.


The COVID-19 pandemic continues to impact Gilead's business and broader market dynamics, including HCV and HIV market volume. Gilead expects a gradual recovery in underlying market dynamics starting the second quarter 2021. Gilead expects that its HIV treatment business will continue to remain largely unaffected and that patients with HCV will begin to initiate treatment by the second quarter 2021. Truvada and Atripla sales are expected to continue to decline in the first quarter 2021 and beyond as multiple generics are expected to enter the market starting in the second quarter 2021. Biktarvy, Trodelvy, Vemlidy and cell therapy are expected to be key growth drivers in 2021 absorbing the full year impact of Truvada and Atripla loss of exclusivity in the United States. The acquisition of Immunomedics will immediately contribute to Gilead's revenue growth and is expected to be neutral to accretive to Gilead's non-GAAP EPS in 2023 and significantly accretive thereafter. Gilead is well positioned to drive its future growth potential through its renewed pipeline in oncology. Gilead's capital allocation priorities remain unchanged and will continue to prioritize investment in its business and R&D pipeline and maintain a focus on disciplined expense management. The fundamentals of Gilead's business and long-term outlook remain strong.

Key Product, Pipeline and Corporate Updates(1)

(MORE TO FOLLOW) Dow Jones Newswires

February 04, 2021 16:01 ET (21:01 GMT)