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     505  0 Kommentare Gilead Sciences Announces Fourth Quarter and Full Year 2022 Financial Results

    Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the fourth quarter and full year 2022.

    “2022 marked Gilead’s strongest full year growth in our base business since HCV sales peaked in 2015. This return to growth was driven by consistent and high quality commercial and clinical execution across our portfolio,” said Gilead’s Chairman and Chief Executive Officer Daniel O’Day. “In HIV, Biktarvy gained market share in the U.S. as it has every quarter since launch, while our long-acting HIV agent, lenacapavir, received its first regulatory approvals. The strong full year growth in oncology was driven by continued increase in demand for Trodelvy and our Cell Therapies. We look forward to building on this momentum in 2023 and further increasing our impact for people and communities worldwide.”

    Fourth Quarter 2022 Financial Results

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    • Total fourth quarter 2022 revenue of $7.4 billion increased 2% compared to the same period in 2021, primarily due to increased sales in Oncology, HIV and hepatitis C virus (“HCV”), partially offset by lower Veklury (remdesivir) sales.
    • Diluted Earnings Per Share (“EPS”) increased to $1.30 for the fourth quarter 2022 compared to $0.30 for the same period in 2021. Non-GAAP diluted EPS increased to $1.67 for the fourth quarter 2022 compared to $0.69 for the same period in 2021. The increase was primarily driven by two charges in the fourth quarter of 2021 which did not recur in 2022: the $1.25 billion charge for a legal settlement and the $625 million charge for the Arcus Biosciences, Inc. (“Arcus”) collaboration opt-in. The fourth quarter 2022 was, however, impacted by expenses related to the acquisition of GS-1811 from Jounce Therapeutics, Inc. (“Jounce”), the collaboration with MacroGenics, Inc. (“MacroGenics”), and the termination of the Trodelvy collaboration agreement with Everest Medicines (“Everest”), as well as higher R&D expenses.
    • As of December 31, 2022, Gilead had $7.6 billion of cash, cash equivalents and marketable debt securities compared to $7.8 billion as of December 31, 2021.
    • During the fourth quarter 2022, Gilead generated $2.6 billion in operating cash flow.
    • During the fourth quarter 2022, Gilead paid cash dividends of $916 million and utilized $791 million to repurchase common stock.

    Product Sales Performance for the Fourth Quarter 2022

    Total fourth quarter 2022 product sales increased 2% to $7.3 billion compared to the same period in 2021. Total product sales excluding Veklury increased 9% to $6.3 billion for the fourth quarter 2022 compared to the same period in 2021, primarily due to increased sales in HIV and Oncology as well as contributions from HCV products.

    HIV product sales increased 5% to $4.8 billion for the fourth quarter 2022 compared to the same period in 2021, reflecting higher demand and favorable pricing dynamics, partially offset by channel inventory dynamics in the United States.

    • Biktarvy (bictegravir 50mg/emtricitabine (“FTC”) 200mg/tenofovir alafenamide (“TAF”) 25mg) sales increased 15% to $2.9 billion for the fourth quarter 2022 compared to the same period in 2021, primarily reflecting higher demand and favorable pricing dynamics, partially offset by lower channel inventory.
    • Descovy (FTC 200mg/TAF 25mg) sales increased 13% to $537 million for the fourth quarter 2022 compared to the same period in 2021, primarily driven by favorable pricing dynamics as well as higher demand, partially offset by lower channel inventory.

    HCV product sales increased 12% to $439 million for the fourth quarter 2022 compared to the same period in 2021, primarily driven by increased patient starts and favorable pricing dynamics in the United States, partially offset by fewer starts in Europe.

    Hepatitis B virus (“HBV”) and hepatitis delta virus (“HDV”) product sales decreased 4% to $255 million for the fourth quarter 2022 compared to the same period in 2021. Vemlidy (TAF 25 mg) sales decreased 2% in the fourth quarter 2022 compared to the same period in 2021, driven primarily by lower demand and pricing dynamics outside of the United States. Hepcludex (bulevirtide) contributed $13 million in the fourth quarter 2022 as launch activities continued across Europe.

    Cell Therapy product sales increased 75% to $419 million for the fourth quarter 2022 compared to the same period in 2021.

    • Yescarta (axicabtagene ciloleucel) sales increased to $337 million in the fourth quarter 2022, primarily driven by increased demand in relapsed or refractory (“R/R”) large B-cell lymphoma (“LBCL”) in the United States and Europe.
    • Tecartus (brexucabtagene autoleucel) sales increased to $82 million in the fourth quarter 2022, driven by increased demand in adult R/R B-cell precursor acute lymphoblastic leukemia (“ALL”) and mantle cell lymphoma (“MCL”) in the United States and Europe.

    Trodelvy (sacituzumab govitecan-hziy) sales increased 65% to $195 million for the fourth quarter 2022 compared to the same period in 2021, reflecting continued adoption in metastatic triple-negative breast cancer (“TNBC”) in the United States and Europe.

    Veklury sales decreased 26% to $1.0 billion for the fourth quarter 2022 compared to the same period in 2021, primarily driven by lower rates of COVID-19 related hospitalizations. Veklury sales generally reflect COVID-19 related rates and severity of infections and hospitalizations, as well as the availability, uptake and effectiveness of vaccinations and alternative treatments for COVID-19.

    Fourth Quarter 2022 Product Gross Margin, Operating Expenses and Tax

    • Product gross margin was 81.0% for the fourth quarter 2022 compared to 63.3% in the same period in 2021. Non-GAAP product gross margin was 86.8% for the fourth quarter 2022 compared to 70.5% in the same period in 2021. Higher product gross margin in 2022 is primarily driven by a charge related to a legal settlement in the fourth quarter 2021 that did not repeat.
    • R&D expenses for the fourth quarter 2022 were $1.5 billion compared to $1.4 billion(1) in the same period in 2021. Non-GAAP R&D expenses for the fourth quarter 2022 were $1.5 billion compared to $1.3 billion(1) in the same period in 2021. Higher R&D expenses primarily reflect increased clinical activities, mainly in Oncology.
    • Acquired in-process research and development (“IPR&D”) expenses for the fourth quarter 2022 were $158 million compared to $669 million(1) in the same period in 2021. Fourth quarter 2022 expenses primarily relate to the acquisition of GS-1811 from Jounce and the MacroGenics upfront payment. Fourth quarter 2021 expenses mostly relate to the charge for the Arcus collaboration opt-in.
    • Selling, General and Administrative (“SG&A”) expenses for the fourth quarter 2022 were $2.0 billion compared to $1.7 billion in the same period in 2021. Non-GAAP SG&A expenses for the fourth quarter 2022 were $2.0 billion compared to $1.6 billion in the same period in 2021. SG&A expenses increased primarily due to the charge of $406 million associated with the termination of the Trodelvy collaboration agreement with Everest, which had provided Everest with broad commercialization and development rights to Trodelvy in certain Asia territories. Gilead terminated the existing agreement and reacquired the Trodelvy rights in these territories.
    • The effective tax rate (“ETR”) and non-GAAP ETR for the fourth quarter 2022 were 19.6% and 16.8%, respectively, compared to 50.5% and 32.2%, respectively, for the same period in 2021. The lower ETR reflects discrete tax charges recorded in the fourth quarter of 2021 that did not repeat.

    Full Year 2022 Financial Results

    • Total full year 2022 revenue of $27.3 billion was flat compared to 2021, driven by increased sales in Oncology and HIV, offset by lower sales of Veklury.
    • Diluted EPS decreased to $3.64 for the full year 2022 compared to $4.93 in 2021. The decrease in diluted EPS was driven by an IPR&D impairment charge in the first quarter 2022 related to assets acquired by Gilead from Immunomedics in 2020, as well as the termination of the Trodelvy collaboration agreement with Everest and higher R&D expenses. This was partially offset by charges in the fourth quarter of 2021 that did not repeat related to a legal settlement.
    • Non-GAAP diluted EPS increased 1% to $7.26 for the full year 2022 compared to $7.18 in 2021. The increase in non-GAAP diluted EPS was primarily due to a legal settlement charge in the fourth quarter of 2021 that did not repeat. This was partially offset by an increase in SG&A expenses mostly associated with the termination of the Trodelvy collaboration agreement with Everest and higher R&D expenses.

    Product Sales Performance for the Full Year 2022

    Total full year 2022 product sales were $27.0 billion for the full year 2022 and remained flat compared to the same period in 2021, with growth in HIV, Cell Therapy and Trodelvy, offset by lower Veklury sales. Total product sales excluding Veklury increased 8% to $23.1 billion for the full year 2022 compared to 2021 primarily driven by increased sales in HIV, Cell Therapy and Trodelvy.

    HIV product sales increased 5% to $17.2 billion for the full year 2022 compared to 2021, primarily reflecting higher demand and favorable pricing dynamics, partially offset by channel inventory dynamics and unfavorable foreign exchange rates.

    • Biktarvy sales increased 20% to $10.4 billion for the full year 2022, primarily reflecting higher demand in addition to favorable pricing dynamics, partially offset by inventory dynamics.
    • Descovy sales increased 10% to $1.9 billion for the full year 2022, primarily driven by favorable pricing dynamics and higher demand, partially offset by inventory dynamics.

    HCV product sales decreased 4% to $1.8 billion for the full year 2022 compared to 2021, primarily due to unfavorable foreign exchange rates, as well as fewer patient starts and unfavorable pricing dynamics.

    HBV and HDV product sales increased 2% to $988 million for the full year 2022 compared to 2021, driven primarily by higher demand for Vemlidy, mainly in the United States.

    Cell Therapy product sales increased 68% to $1.5 billion for the full year 2022 compared to 2021, primarily due to higher demand for Yescarta in R/R LBCL, as well as Tecartus in R/R ALL and MCL.

    Trodelvy sales increased 79% to $680 million for the full year 2022 compared to 2021, reflecting continued adoption in metastatic TNBC in the United States and Europe.

    Veklury sales decreased 30% to $3.9 billion for the full year 2022 compared to 2021, primarily driven by lower rates of COVID-19 related hospitalizations.

    Full Year 2022 Product Gross Margin, Operating Expenses and Tax

    • Product gross margin was 79.0% for the full year 2022 compared to 75.6% in 2021. Non-GAAP product gross margin was 86.6% for the full year 2022 compared to 83.2% in 2021. Higher product gross margin is primarily driven by a charge related to a legal settlement in the fourth quarter 2021 that did not repeat, slightly offset by other year-over-year changes.
    • R&D expenses for the full year 2022 were $5.0 billion compared to $4.6 billion(1) in 2021. Non-GAAP R&D expenses for the full year 2022 were $5.0 billion compared to $4.5 billion(1) in 2021. Higher R&D expenses primarily reflect increased clinical activities, mainly in Oncology, as well as inflationary increases.
    • Acquired IPR&D expenses for the full year 2022 were $944 million compared to $939 million(1) in the same period in 2021.
    • SG&A expenses for the full year 2022 were $5.7 billion compared to $5.2 billion in 2021. Non-GAAP SG&A expenses for full year 2022 were $5.6 billion compared to $5.0 billion in 2021. SG&A expenses increased primarily due to the charge of $406 million associated with the termination of the Trodelvy collaboration with Everest, increased promotional and marketing investment, mostly in Trodelvy and Cell Therapy, as well as higher corporate activities and inflationary increases. GAAP SG&A expenses were slightly offset by a decrease in donations to the Gilead Foundation in 2022 as compared to prior year.
    • The ETR and non-GAAP ETR for the full year 2022 were 21.5% and 19.3%, respectively, compared to 25.1% and 20.4%, respectively, in 2021. Lower ETR is primarily due to a beneficial change in jurisdictional mix of income and lower state taxes in 2022.

    ________________________________

    (1)

    Beginning in the second quarter of 2022, expenses related to development milestones and other collaboration payments made prior to regulatory approval of a developed product were reclassified from R&D expenses to Acquired IPR&D expenses in the Condensed Consolidated Statements of Income. We believe this presentation assists users of the financial statements to better understand the total costs incurred to acquire IPR&D projects. Prior periods have been recast for both GAAP and Non-GAAP reporting to reflect this classification, resulting in a reduction of previously reported R&D expenses of $669 million and $762 million for the fourth quarter and full year 2021, respectively, and $8 million for the three months ended March 31, 2022.

    Guidance and Outlook

    Gilead is providing full-year 2023 guidance below:

    • Total product sales between $26.0 billion and $26.5 billion.
    • Total product sales, excluding Veklury, between $24.0 billion and $24.5 billion.
    • Total Veklury sales of approximately $2.0 billion are expected to be highly variable, depending on the frequency and severity of surges, and our guidance will continue to be updated on a quarterly basis as necessary.
    • Earnings per share between $5.30 and $5.70.
    • Non-GAAP earnings per share between $6.60 and $7.00.

    A reconciliation between GAAP and non-GAAP financial information for the 2023 guidance is provided in the accompanying tables. Also see the Forward-Looking Statements described below. The financial guidance is subject to a number of risks and uncertainties, including uncertainty around the duration and magnitude of the COVID-19 pandemic.

    Key Updates Since Our Last Quarterly Release

    Virology

    • Announced FDA approval of Sunlenca (lenacapavir), in combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant HIV-1 infection.
    • Announced the European Commission (“EC”) authorized an extended indication and line extension for a low-dosage tablet form of Biktarvy (bictegravir 30mg/FTC 120mg/TAF 15mg) for the treatment of HIV in virologically suppressed children who are at least 2 years of age and weigh at least 14 kg.
    • Announced FDA approval of Vemlidy for the treatment of chronic HBV infection in pediatric patients 12 years and older with compensated liver disease.

    Oncology

    • Announced that the European Medicines Agency has validated a Type II variation of the Marketing Authorization Application for Trodelvy for the treatment of adult patients with pre-treated HR+/HER2- metastatic breast cancer (“mBC”).
    • Presented post-hoc analysis from the Phase 3 TROPiCS-02 study of Trodelvy in HR+/HER2- mBC at the 2022 San Antonio Breast Cancer Symposium. In the analysis Trodelvy demonstrated consistent efficacy across Trop-2 expression levels in patients with pre-treated HR+/HER2- mBC with improvement across progression-free survival (“PFS”), overall survival and objective response rate as compared to standard chemotherapy. The safety profile for Trodelvy was consistent with prior studies, with no new safety signals identified in this population.
    • Announced the transfer of the Marketing Authorization for Yescarta in Japan from Daiichi Sankyo Co., Ltd. (“Daiichi Sankyo”) to Gilead K.K. in 2023.
    • Received approval from the Ministry of Health, Labour and Welfare in Japan for Yescarta for the initial treatment of R/R LBCL.
    • Entered into a strategic collaboration between Kite, a Gilead company, and Arcellx, Inc. (“Arcellx”) to co-develop and co-commercialize CART-ddBMCA, a late-stage clinical asset in development for the treatment of multiple myeloma.
    • Entered into an agreement to acquire Tmunity Therapeutics Inc. (“Tmunity”), a clinical stage private biotech company, which will provide Kite with preclinical and clinical programs, including an “armored” CAR T technology platform that has the potential to be applied to a variety of CAR Ts to enhance anti-tumor activity, as well as rapid manufacturing processes. The transaction is expected to close in the first quarter of 2023.
    • Presented long-term data and real-world analysis of Yescarta and Tecartus at the American Society of Hematology 2022 meeting. Results showed that in a real-world analysis, shorter vein-to-vein times were associated with improved outcomes for patients treated with Yescarta for R/R LBCL. Additionally, in a three-year follow-up analysis of ZUMA-5 in R/R indolent non-Hodgkin lymphoma showed continued response in 52% of patients and prolonged duration of PFS. Three follow-up analyses were presented on Tecartus, including a two-year follow-up of ZUMA-3 compared to SCHOLAR-3 in R/R B-cell acute lymphoblastic leukemia and updated three-year results from ZUMA-2 study in R/R mantle cell lymphoma.
    • Presented positive data, alongside Arcus, from the fourth interim analysis of the Phase 2 ARC-7 study at the American Society of Clinical Oncology Monthly Plenary Session. The study is evaluating the combinations of domvanalimab plus zimberelimab (doublet) and domvanalimab plus zimberelimab and etrumadenant (triplet), versus zimberelimab monotherapy in patients with first-line, metastatic PD-L1-high NSCLC. In the study, both the doublet and triplet combinations demonstrated clinically meaningful improvements in median PFS compared to zimberelimab monotherapy, with a 45% reduction in risk of disease progression or death for the doublet and 35% for the triplet.
    • Acquired the remaining rights to GS-1811, an anti-CCR8 antibody, developed by Jounce for the treatment of solid tumors.

    Inflammation

    • Announced a collaboration and licensing agreement with EVOQ Therapeutics, Inc. (“EVOQ”) to advance EVOQ’s proprietary NanoDisc technology for the treatment of rheumatoid arthritis and lupus.

    Corporate

    • Recognized as one of the most sustainable pharmaceutical companies according to the Dow Jones Sustainability World Index, reflecting Gilead’s ongoing commitment to corporate responsibility.
    • Announced the U.S. Supreme Court denied Juno Therapeutics, Inc.’s appeal in the Juno v. Kite case, effectively ending this patent dispute.

    Certain amounts and percentages in this press release may not sum or recalculate due to rounding.

    Conference Call

    At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on http://investors.gilead.com and will be archived on www.gilead.com for one year.

    Non-GAAP Financial Information

    The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, 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. Non-GAAP financial information generally excludes acquisition-related expenses including amortization of acquired intangible assets and inventory step-up charges, and other items that are considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity securities and discrete and related tax charges or benefits associated with changes in tax related laws and guidelines. Although Gilead consistently excludes the amortization of acquired intangible assets from the non-GAAP financial information, management believes that it is important for investors to understand that such intangible assets were recorded as part of acquisitions and contribute to ongoing revenue generation. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables.

    Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (“SEC”), Gilead no longer excludes the initial costs of acquired IPR&D projects from its non-GAAP financial measures. Prior period non-GAAP financial measures are revised to conform to the new presentation.

    About Gilead Sciences

    Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

    Forward-Looking Statements

    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 those relating to: the impact of the COVID-19 pandemic on Gilead’s business, financial condition and results of operations; the development, manufacturing and distribution of Veklury as a treatment for COVID-19, including the uncertainty of the amount and timing of future Veklury sales and Gilead’s ability to effectively manage the global supply and distribution of Veklury; Gilead’s ability to achieve its anticipated full year 2023 financial results, including as a result of potential adverse revenue impacts from COVID-19 and potential revenues from Veklury; Gilead’s ability to make progress on any of its long-term ambitions or strategic priorities laid out in its corporate strategy; Gilead’s ability to accelerate or sustain revenues for its virology, oncology and other programs; Gilead’s ability to realize the potential benefits of acquisitions, collaborations or licensing arrangements, including those involving Arcellx, Daiichi Sankyo, EVOQ, Jounce and Tmunity; Gilead’s ability to identify suitable transactions as part of its business strategy and the risk that Gilead may not be able to complete any such transaction in a timely manner or at all, including the possibility that a governmental entity or regulatory body may delay or refuse to grant approval for the consummation of the transaction; patent protection and estimated loss of exclusivity for our products and product candidates; Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timeframes or at all, the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Trodelvy, Tecartus, Yescarta, domvanalimab, etrumadenant and zimberelimab, and the risk that safety and efficacy data from clinical trials may not warrant further development of Gilead’s product candidates or the product candidates of Gilead’s strategic partners; Gilead’s ability to submit new drug applications for new product candidates or expanded indications in the currently anticipated timelines; Gilead’s ability to receive regulatory approvals in a timely manner or at all, including EC approval of Trodelvy for the treatment of adult patients with pre-treated HR+/HER2 mBC, and the risk that any such approvals, if granted, may be subject to significant 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, including the risk that Kite may be unable to increase its manufacturing capacity, timely manufacture and deliver its products or produce an amount of supply sufficient to satisfy demand for such products; pricing and reimbursement pressures from government agencies and other third parties, including required rebates and other discounts; 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, including Biktarvy, Sunlenca, Vemlidy and Yescarta; and other risks identified from time to time in Gilead’s 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. 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 December 31, 2022 are not necessarily indicative of operating results for any future periods. Gilead directs readers to its press releases, annual reports on Form 10-K, quarterly reports on Form 10-Q and other subsequent disclosure documents filed with the SEC. Gilead claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements.

    The reader is cautioned that forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these 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.

    # # #

    Gilead owns or has rights to various trademarks, copyrights and trade names used in its business, including the following: GILEAD, GILEAD SCIENCES, KITE, AMBISOME, ATRIPLA, BIKTARVY, CAYSTON, COMPLERA, DESCOVY, DESCOVY FOR PREP, EMTRIVA, EPCLUSA, EVIPLERA, GENVOYA, HARVONI, HEPCLUDEX, HEPSERA, JYSELECA, LETAIRIS, ODEFSEY, RANEXA, SOVALDI, STRIBILD, SUNLENCA , TECARTUS, TRODELVY, TRUVADA, TRUVADA FOR PREP, TYBOST, VEKLURY, VEMLIDY, VIREAD, VOSEVI, YESCARTA and ZYDELIG. This report may also refer to trademarks, service marks and trade names of other companies.

    For more information on Gilead Sciences, Inc., please visit www.gilead.com or call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235).

     

    GILEAD SCIENCES, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF INCOME

    (unaudited)

     

     

     

     

     

     

     

    Three Months Ended

     

    Twelve Months Ended

     

     

    December 31,

     

    December 31,

    (in millions, except per share amounts)

     

    2022

     

    2021

     

    2022

     

    2021

    Revenues:

     

     

     

     

     

     

     

     

    Product sales

     

    $

    7,333

     

     

    $

    7,160

     

     

    $

    26,982

     

     

    $

    27,008

     

    Royalty, contract and other revenues

     

     

    56

     

     

     

    84

     

     

     

    299

     

     

     

    297

     

    Total revenues

     

     

    7,389

     

     

     

    7,244

     

     

     

    27,281

     

     

     

    27,305

     

    Costs and expenses:

     

     

     

     

     

     

     

     

    Cost of goods sold

     

     

    1,396

     

     

     

    2,627

     

     

     

    5,657

     

     

     

    6,601

     

    Research and development expenses

     

     

    1,548

     

     

     

    1,358

     

     

     

    4,977

     

     

     

    4,601

     

    Acquired in-process research and development expenses

     

     

    158

     

     

     

    669

     

     

     

    944

     

     

     

    939

     

    In-process research and development impairment

     

     

     

     

     

     

     

     

    2,700

     

     

     

     

    Selling, general and administrative expenses

     

     

    2,020

     

     

     

    1,650

     

     

     

    5,673

     

     

     

    5,246

     

    Total costs and expenses

     

     

    5,122

     

     

     

    6,304

     

     

     

    19,951

     

     

     

    17,387

     

    Operating income

     

     

    2,267

     

     

     

    940

     

     

     

    7,330

     

     

     

    9,918

     

    Interest expense

     

     

    (227

    )

     

     

    (238

    )

     

     

    (935

    )

     

     

    (1,001

    )

    Other income (expense), net

     

     

    (9

    )

     

     

    57

     

     

     

    (581

    )

     

     

    (639

    )

    Income before income taxes

     

     

    2,031

     

     

     

    759

     

     

     

    5,814

     

     

     

    8,278

     

    Income tax expense

     

     

    (398

    )

     

     

    (383

    )

     

     

    (1,248

    )

     

     

    (2,077

    )

    Net income

     

     

    1,633

     

     

     

    376

     

     

     

    4,566

     

     

     

    6,201

     

    Net loss attributable to noncontrolling interest

     

     

    7

     

     

     

    6

     

     

     

    26

     

     

     

    24

     

    Net income attributable to Gilead

     

    $

    1,640

     

     

    $

    382

     

     

    $

    4,592

     

     

    $

    6,225

     

    Basic earnings per share attributable to Gilead

     

    $

    1.31

     

     

    $

    0.30

     

     

    $

    3.66

     

     

    $

    4.96

     

    Shares used in per share calculation - basic

     

     

    1,252

     

     

     

    1,256

     

     

     

    1,255

     

     

     

    1,256

     

    Diluted earnings per share attributable to Gilead

     

    $

    1.30

     

     

    $

    0.30

     

     

    $

    3.64

     

     

    $

    4.93

     

    Shares used in per share calculation - diluted

     

     

    1,264

     

     

     

    1,262

     

     

     

    1,262

     

     

     

    1,262

     

    Cash dividends declared per share

     

    $

    0.73

     

     

    $

    0.71

     

     

    $

    2.92

     

     

    $

    2.84

     

     

     

     

     

     

     

     

     

     

    Research and development expenses as a % of revenues

     

     

    20.9

    %

     

     

    18.7

    %

     

     

    18.2

    %

     

     

    16.9

    %

    Selling, general and administrative expenses as a % of revenues

     

     

    27.3

    %

     

     

    22.8

    %

     

     

    20.8

    %

     

     

    19.2

    %

     

    GILEAD SCIENCES, INC.

    TOTAL REVENUE SUMMARY

    (unaudited)

     

     

     

     

     

     

     

     

     

     

     

    Three Months Ended

     

     

     

    Twelve Months Ended

     

     

     

     

    December 31,

     

     

     

    December 31,

     

     

    (in millions, except percentages)

     

    2022

     

    2021

     

    Change

     

    2022

     

    2021

     

    Change

    Product sales:

     

     

     

     

     

     

     

     

     

     

     

     

    HIV

     

    $

    4,772

     

    $

    4,538

     

    5

    %

     

    $

    17,194

     

    $

    16,315

     

    5

    %

    HCV

     

     

    439

     

     

    393

     

    12

    %

     

     

    1,810

     

     

    1,881

     

    (4

    )%

    HBV/HDV

     

     

    255

     

     

    265

     

    (4

    )%

     

     

    988

     

     

    969

     

    2

    %

    Cell Therapy

     

     

    419

     

     

    239

     

    75

    %

     

     

    1,459

     

     

    871

     

    68

    %

    Trodelvy

     

     

    195

     

     

    118

     

    65

    %

     

     

    680

     

     

    380

     

    79

    %

    Other

     

     

    252

     

     

    250

     

    1

    %

     

     

    946

     

     

    1,027

     

    (8

    )%

    Total product sales excluding Veklury

     

     

    6,333

     

     

    5,803

     

    9

    %

     

     

    23,077

     

     

    21,443

     

    8

    %

    Veklury

     

     

    1,000

     

     

    1,357

     

    (26

    )%

     

     

    3,905

     

     

    5,565

     

    (30

    )%

    Total product sales

     

     

    7,333

     

     

    7,160

     

    2

    %

     

     

    26,982

     

     

    27,008

     

    %

    Royalty, contract and other revenues

     

     

    56

     

     

    84

     

    (33

    )%

     

     

    299

     

     

    297

     

    1

    %

    Total revenues

     

    $

    7,389

     

    $

    7,244

     

    2

    %

     

    $

    27,281

     

    $

    27,305

     

    %

     

    GILEAD SCIENCES, INC.

    NON-GAAP FINANCIAL INFORMATION(1)

    (unaudited)

     

     

     

     

     

     

     

     

     

     

     

    Three Months Ended

     

     

     

    Twelve Months Ended

     

     

     

     

    December 31,

     

     

     

    December 31,

     

     

    (in millions, except percentages)

     

    2022

     

    2021

     

    Change

     

    2022

     

    2021

     

    Change

    Non-GAAP:

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of goods sold

     

    $

    968

     

     

    $

    2,111

     

     

    (54

    )%

     

    $

    3,602

     

     

    $

    4,538

     

     

    (21

    )%

    Research and development expenses

     

    $

    1,544

     

     

    $

    1,315

     

     

    17

    %

     

    $

    4,968

     

     

    $

    4,464

     

     

    11

    %

    Acquired IPR&D expenses

     

    $

    158

     

     

    $

    669

     

     

    (76

    )%

     

    $

    944

     

     

    $

    939

     

     

    1

    %

    Selling, general and administrative expenses

     

    $

    2,020

     

     

    $

    1,642

     

     

    23

    %

     

    $

    5,587

     

     

    $

    4,974

     

     

    12

    %

    Other income (expense), net

     

    $

    52

     

     

    $

     

     

    NM

     

     

    $

    77

     

     

    $

    (29

    )

     

    NM

     

    Diluted EPS

     

    $

    1.67

     

     

    $

    0.69

     

     

    141

    %

     

    $

    7.26

     

     

    $

    7.18

     

     

    1

    %

     

     

     

     

     

     

     

     

     

     

     

     

     

    Product gross margin

     

     

    86.8

    %

     

     

    70.5

    %

     

    1628 bps

     

     

    86.6

    %

     

     

    83.2

    %

     

    345 bps

    Research and development expenses as a % of revenues

     

     

    20.9

    %

     

     

    18.2

    %

     

    274 bps

     

     

    18.2

    %

     

     

    16.3

    %

     

    186 bps

    Selling, general and administrative expenses as a % of revenues

     

     

    27.3

    %

     

     

    22.7

    %

     

    468 bps

     

     

    20.5

    %

     

     

    18.2

    %

     

    226 bps

    Operating margin

     

     

    36.5

    %

     

     

    20.8

    %

     

    1573 bps

     

     

    44.6

    %

     

     

    45.4

    %

     

    -75 bps

    Effective tax rate

     

     

    16.8

    %

     

     

    32.2

    %

     

    -1540 bps

     

     

    19.3

    %

     

     

    20.4

    %

     

    -110 bps

    ________________________________

    NM - Not Meaningful

    (1)

    Refer to Non-GAAP Financial Information section above for further disclosures on non-GAAP financial measures. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 12 - 13. Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission, the Company no longer excludes the initial costs of acquired IPR&D projects from its non-GAAP financial measures. Prior period non-GAAP financial measures are revised to conform to the new presentation.

     

    GILEAD SCIENCES, INC.

    RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION

    (unaudited)

     

     

     

     

     

     

     

    Three Months Ended

     

    Twelve Months Ended

     

     

    December 31,

     

    December 31,

    (in millions, except percentages and per share amounts)

     

    2022

     

    2021

     

    2022

     

    2021

    Cost of goods sold reconciliation:

     

     

     

     

     

     

     

     

    GAAP cost of goods sold

     

    $

    1,396

     

     

    $

    2,627

     

     

    $

    5,657

     

     

    $

    6,601

     

    Acquisition-related – amortization of acquired intangibles and inventory step-up charges

     

     

    (428

    )

     

     

    (516

    )

     

     

    (2,013

    )

     

     

    (2,063

    )

    Other(1)

     

     

     

     

     

     

     

     

    (42

    )

     

     

     

    Non-GAAP cost of goods sold

     

    $

    968

     

     

    $

    2,111

     

     

    $

    3,602

     

     

    $

    4,538

     

     

     

     

     

     

     

     

     

     

    Product gross margin reconciliation:

     

     

     

     

     

     

     

     

    GAAP product gross margin

     

     

    81.0

    %

     

     

    63.3

    %

     

     

    79.0

    %

     

     

    75.6

    %

    Acquisition-related – amortization of acquired intangibles and inventory step-up charges

     

     

    5.8

    %

     

     

    7.2

    %

     

     

    7.5

    %

     

     

    7.6

    %

    Other(1)

     

     

    %

     

     

    %

     

     

    0.2

    %

     

     

    %

    Non-GAAP product gross margin

     

     

    86.8

    %

     

     

    70.5

    %

     

     

    86.6

    %

     

     

    83.2

    %

     

     

     

     

     

     

     

     

     

    Research and development expenses reconciliation:

     

     

     

     

     

     

     

     

    GAAP research and development expenses

     

    $

    1,548

     

     

    $

    1,358

     

     

    $

    4,977

     

     

    $

    4,601

     

    Acquisition-related – amortization of inventory step-up charges

     

     

     

    .

     

    (42

    )

     

     

     

     

     

    (109

    )

    Acquisition-related – other costs(2)

     

     

    (1

    )

    .

     

     

     

     

    13

     

     

     

    (14

    )

    Other(1)

     

     

    (4

    )

    .

     

    (1

    )

     

     

    (22

    )

     

     

    (14

    )

    Non-GAAP research and development expenses

     

    $

    1,544

     

     

    $

    1,315

     

     

    $

    4,968

     

     

    $

    4,464

     

     

     

     

     

     

     

     

     

     

    IPR&D impairment reconciliation:

     

     

     

     

     

     

     

     

    GAAP IPR&D impairment

     

    $

     

     

    $

     

     

    $

    2,700

     

     

    $

     

    IPR&D impairment

     

     

     

    .

     

     

     

     

    (2,700

    )

     

     

     

    Non-GAAP IPR&D impairment

     

    $

     

     

    $

     

     

    $

     

     

    $

     

     

     

     

     

     

     

     

     

     

    Selling, general and administrative expenses reconciliation:

     

     

     

     

     

     

     

     

    GAAP selling, general and administrative expenses

     

    $

    2,020

     

     

    $

    1,650

     

     

    $

    5,673

     

     

    $

    5,246

     

    Acquisition-related – other costs(2)

     

     

    (1

    )

    .

     

    (3

    )

     

     

    (3

    )

     

     

    (45

    )

    Other(1)

     

     

    1

     

    .

     

    (5

    )

     

     

    (83

    )

     

     

    (227

    )

    Non-GAAP selling, general and administrative expenses

     

    $

    2,020

     

     

    $

    1,642

     

     

    $

    5,587

     

     

    $

    4,974

     

     

     

     

     

     

     

     

     

     

    Operating income reconciliation:

     

     

     

     

     

     

     

     

    GAAP operating income

     

    $

    2,267

     

     

    $

    940

     

     

    $

    7,330

     

     

    $

    9,918

     

    Acquisition-related – amortization of acquired intangibles and inventory step-up charges

     

     

    428

     

    .

     

    558

     

     

     

    2,013

     

     

     

    2,172

     

    Acquisition-related – other costs(2)

     

     

    2

     

    .

     

    3

     

     

     

    (10

    )

     

     

    59

     

    IPR&D impairment

     

     

     

    .

     

     

     

     

    2,700

     

     

     

     

    Other(1)

     

     

    2

     

    .

     

    6

     

     

     

    147

     

     

     

    241

     

    Non-GAAP operating income

     

    $

    2,699

     

     

    $

    1,507

     

     

    $

    12,180

     

     

    $

    12,390

     

     

     

     

     

     

     

     

     

     

    Operating margin reconciliation:

     

     

     

     

     

     

     

     

    GAAP operating margin

     

     

    30.7

    %

     

     

    13.0

    %

     

     

    26.9

    %

     

     

    36.3

    %

    Acquisition-related – amortization of acquired intangibles and inventory step-up charges

     

     

    5.8

    %

     

     

    7.7

    %

     

     

    7.4

    %

     

     

    8.0

    %

    Acquisition-related – other costs(2)

     

     

    %

     

     

    0.1

    %

     

     

    %

     

     

    0.2

    %

    IPR&D impairment

     

     

    %

     

     

    %

     

     

    9.9

    %

     

     

    %

    Other(1)

     

     

    %

     

     

    %

     

     

    0.5

    %

     

     

    0.9

    %

    Non-GAAP operating margin

     

     

    36.5

    %

     

     

    20.8

    %

     

     

    44.6

    %

     

     

    45.4

    %

     

     

     

     

     

     

     

     

     

    Other income (expense), net reconciliation:

     

     

     

     

     

     

     

     

    GAAP other income (expense), net

     

    $

    (9

    )

     

    $

    57

     

     

    $

    (581

    )

     

    $

    (639

    )

    Loss (gain) from equity securities, net

     

     

    61

     

     

     

    (57

    )

     

     

    657

     

     

     

    610

     

    Non-GAAP other income (expense), net

     

    $

    52

     

     

    $

     

     

    $

    77

     

     

    $

    (29

    )

     

    GILEAD SCIENCES, INC.

    RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued)

    (unaudited)

     

     

     

     

     

     

     

    Three Months Ended

     

    Twelve Months Ended

     

     

    December 31,

     

    December 31,

    (in millions, except percentages and per share amounts)

     

    2022

     

    2021

     

    2022

     

    2021

    Effective tax rate reconciliation:

     

     

     

     

     

     

     

     

    GAAP effective tax rate

     

     

    19.6

    %

     

     

    50.5

    %

     

     

    21.5

    %

     

     

    25.1

    %

    Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments(3)

     

     

    (2.8

    )%

     

     

    (18.3

    )%

     

     

    (2.1

    )%

     

     

    (4.7

    )%

    Non-GAAP effective tax rate

     

     

    16.8

    %

     

     

    32.2

    %

     

     

    19.3

    %

     

     

    20.4

    %

     

     

     

     

     

     

     

     

     

    Net income attributable to Gilead reconciliation:

     

     

     

     

     

     

     

     

    GAAP net income attributable to Gilead

     

    $

    1,640

     

     

    $

    382

     

     

    $

    4,592

     

     

    $

    6,225

     

    Acquisition-related – amortization of acquired intangibles and inventory step-up charges

     

     

    346

     

     

     

    449

     

     

     

    1,610

     

     

     

    1,750

     

    Acquisition-related – other costs(2)

     

     

    1

     

     

     

     

     

     

    (12

    )

     

     

    46

     

    IPR&D impairment

     

     

     

    .

     

     

     

     

    2,057

     

     

     

     

    Other(1)

     

     

    2

     

    .

     

    3

     

     

     

    106

     

     

     

    146

     

    Loss (gain) from equity securities, net

     

     

    60

     

     

     

    (56

    )

     

     

    630

     

     

     

    631

     

    Discrete and related tax charges(3)

     

     

    57

     

     

     

    88

     

     

     

    175

     

     

     

    267

     

    Non-GAAP net income attributable to Gilead

     

    $

    2,106

     

     

    $

    866

     

     

    $

    9,158

     

     

    $

    9,065

     

     

     

     

     

     

     

     

     

     

    Diluted EPS reconciliation:

     

     

     

     

     

     

     

     

    GAAP diluted EPS

     

    $

    1.30

     

     

    $

    0.30

     

     

    $

    3.64

     

     

    $

    4.93

     

    Acquisition-related – amortization of acquired intangibles and inventory step-up charges

     

     

    0.27

     

     

     

    0.36

     

     

     

    1.28

     

     

     

    1.39

     

    Acquisition-related – other costs(2)

     

     

     

     

     

     

     

     

    (0.01

    )

     

     

    0.04

     

    IPR&D impairment

     

     

     

     

     

     

     

     

    1.63

     

     

     

     

    Other(1)

     

     

     

     

     

     

     

     

    0.08

     

     

     

    0.11

     

    Loss (gain) from equity securities, net

     

     

    0.05

     

     

     

    (0.04

    )

     

     

    0.50

     

     

     

    0.50

     

    Discrete and related tax charges(3)

     

     

    0.05

     

     

     

    0.07

     

     

     

    0.14

     

     

     

    0.21

     

    Non-GAAP diluted EPS

     

    $

    1.67

     

     

    $

    0.69

     

     

    $

    7.26

     

     

    $

    7.18

     

     

     

     

     

     

     

     

     

     

    Non-GAAP adjustment summary:

     

     

     

     

     

     

     

     

    Cost of goods sold adjustments

     

    $

    428

     

     

    $

    516

     

     

    $

    2,055

     

     

    $

    2,063

     

    Research and development expenses adjustments

     

     

    4

     

     

     

    43

     

     

     

    9

     

     

     

    137

     

    IPR&D impairment adjustments

     

     

     

     

     

     

     

     

    2,700

     

     

     

     

    Selling, general and administrative expenses adjustments

     

     

     

     

     

    8

     

     

     

    86

     

     

     

    272

     

    Total non-GAAP adjustments before other income (expense), net, and income taxes

     

     

    432

     

     

     

    567

     

     

     

    4,850

     

     

     

    2,472

     

    Other income (expense), net, adjustments

     

     

    61

     

     

     

    (57

    )

     

     

    657

     

     

     

    610

     

    Total non-GAAP adjustments before income taxes

     

     

    493

     

     

     

    510

     

     

     

    5,507

     

     

     

    3,082

     

    Income tax effect of non-GAAP adjustments above

     

     

    (84

    )

     

     

    (114

    )

     

     

    (1,116

    )

     

     

    (509

    )

    Discrete and related tax charges(3)

     

     

    57

     

     

     

    88

     

     

     

    175

     

     

     

    267

     

    Total non-GAAP adjustments after tax

     

    $

    466

     

     

    $

    484

     

     

    $

    4,566

     

     

    $

    2,840

     

    ______________________________

    (1)

    Adjustments to Cost of goods sold and Research and development expenses primarily include various restructuring expenses during the first quarter of 2022 and the second quarter of 2021. Adjustments to Selling, general and administrative expenses primarily include donations to the Gilead Foundation, a California nonprofit organization, during the second quarters of 2022 and 2021.

    (2)

    Adjustments include employee-related expenses, contingent consideration fair value adjustments and other expenses associated with Gilead’s acquisitions of MiroBio, Ltd., Immunomedics, Inc. and MYR GmbH.

    (3)

    Represents discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and transfers of intangible assets from a foreign subsidiary to Ireland and the United States.

     

    GILEAD SCIENCES, INC.

    RECONCILIATION OF GAAP TO NON-GAAP 2023 FULL YEAR GUIDANCE(1)

    (unaudited)

     

    (in millions, except percentages and per share amounts)

     

    Provided
    February 2, 2023

    Projected product gross margin GAAP to non-GAAP reconciliation:

     

     

    GAAP projected product gross margin

     

    79.0%

    Acquisition-related expenses

     

    ~ 7%

    Non-GAAP projected product gross margin

     

    86.0%

     

     

     

    Projected operating income GAAP to non-GAAP reconciliation:

     

     

    GAAP projected operating income

     

    $9,200 - $9,800

    Acquisition-related expenses

     

    ~ 1,800

    Non-GAAP projected operating income

     

    $11,000 - $11,600

     

     

     

    Projected effective tax rate GAAP to non-GAAP reconciliation:

     

     

    GAAP projected effective tax rate

     

    ~ 22%

    Discrete and related tax adjustments, and income tax effect of adjustments above

     

    (~ 2%)

    Non-GAAP projected effective tax rate

     

    ~ 20%

     

     

     

    Projected diluted EPS GAAP to non-GAAP reconciliation:

     

     

    GAAP projected diluted EPS

     

    $5.30 - $5.70

    Acquisition-related expenses and tax adjustments

     

    ~ 1.30

    Non-GAAP projected diluted EPS

     

    $6.60 - $7.00

    ________________________________

    (1)

    The non-GAAP 2023 full-year guidance includes non-GAAP adjustments to actual current period results as well as adjustments for the known future impact associated with events that have already occurred, such as future amortization of our intangible assets and the future impact of discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and transfers of intangible assets from a foreign subsidiary to Ireland and the United States. Our full-year guidance excludes the potential impact of any (i) acquisitions or business development transactions that have not been executed, (ii) future fair value adjustments of equity securities and (iii) discrete tax charges or benefits associated with changes in tax related laws and guidelines that have not been enacted, as Gilead is unable to project such amounts.

     

    GILEAD SCIENCES, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (unaudited)

     

     

     

    December 31,

    (in millions)

     

    2022

     

    2021

    Assets

     

     

     

     

    Cash, cash equivalents and marketable securities

     

    $

    7,630

     

     

    $

    7,829

     

    Accounts receivable, net

     

     

    4,777

     

     

     

    4,493

     

    Inventories

     

     

    2,820

     

     

     

    2,734

     

    Property, plant and equipment, net

     

     

    5,475

     

     

     

    5,121

     

    Intangible assets, net

     

     

    28,894

     

     

     

    33,455

     

    Goodwill

     

     

    8,314

     

     

     

    8,332

     

    Other assets

     

     

    5,261

     

     

     

    5,988

     

    Total assets

     

    $

    63,171

     

     

    $

    67,952

     

    Liabilities and Stockholders’ Equity

     

     

     

     

    Current liabilities

     

    $

    11,237

     

     

    $

    11,610

     

    Long-term liabilities

     

     

    30,725

     

     

     

    35,278

     

    Stockholders’ equity(1)

     

     

    21,209

     

     

     

    21,064

     

    Total liabilities and stockholders’ equity

     

    $

    63,171

     

     

    $

    67,952

     

    ________________________________

    (1)

    As of December 31, 2022 and 2021, there were 1,247 and 1,254 shares of common stock issued and outstanding, respectively.

     

    GILEAD SCIENCES, INC.

    SELECTED CASH FLOW INFORMATION

    (unaudited)

     

     

     

     

     

     

     

    Three Months Ended

     

    Twelve Months Ended

     

     

    December 31,

     

    December 31,

    (in millions)

     

    2022

     

    2021

     

    2022

     

    2021

    Net cash provided by operating activities

     

    $

    2,566

     

     

    $

    3,205

     

     

    $

    9,072

     

     

    $

    11,384

     

    Net cash used in investing activities

     

     

    (374

    )

     

     

    (278

    )

     

     

    (2,466

    )

     

     

    (3,131

    )

    Net cash used in financing activities

     

     

    (1,554

    )

     

     

    (1,942

    )

     

     

    (6,469

    )

     

     

    (8,877

    )

    Effect of exchange rate changes on cash and cash equivalents

     

     

    75

     

     

     

    (9

    )

     

     

    (63

    )

     

     

    (35

    )

    Net change in cash and cash equivalents

     

     

    713

     

     

     

    976

     

     

     

    74

     

     

     

    (659

    )

    Cash and cash equivalents at beginning of period

     

     

    4,699

     

     

     

    4,362

     

     

     

    5,338

     

     

     

    5,997

     

    Cash and cash equivalents at end of period

     

    $

    5,412

     

     

    $

    5,338

     

     

    $

    5,412

     

     

    $

    5,338

     

     

     

    Three Months Ended

     

    Twelve Months Ended

     

     

    December 31,

     

    December 31,

    (in millions)

     

    2022

     

    2021

     

    2022

     

    2021

    Net cash provided by operating activities

     

    $

    2,566

     

     

    $

    3,205

     

     

    $

    9,072

     

     

    $

    11,384

     

    Capital expenditures

     

     

    (181

    )

     

     

    (156

    )

     

     

    (728

    )

     

     

    (579

    )

    Free cash flow

     

    $

    2,386

     

     

    $

    3,049

     

     

    $

    8,344

     

     

    $

    10,805

     

     

    GILEAD SCIENCES, INC.

    PRODUCT SALES SUMMARY

    (unaudited)

     

     

     

     

     

     

     

    Three Months Ended

     

    Twelve Months Ended

     

     

    December 31,

     

    December 31,

    (in millions)

     

    2022

     

    2021

     

    2022

     

    2021

    HIV

     

     

     

     

     

     

     

     

    Biktarvy – U.S.

     

    $

    2,423

     

     

    $

    2,123

     

     

    $

    8,510

     

     

    $

    7,049

     

    Biktarvy – Europe

     

     

    295

     

     

     

    262

     

     

     

    1,103

     

     

     

    969

     

    Biktarvy – Other International

     

     

    200

     

     

     

    145

     

     

     

    777

     

     

     

    606

     

     

     

     

    2,918

     

     

     

    2,530

     

     

     

    10,390

     

     

     

    8,624

     

     

     

     

     

     

     

     

     

     

    Complera / Eviplera – U.S.

     

     

    17

     

     

     

    29

     

     

     

    74

     

     

     

    102

     

    Complera / Eviplera – Europe

     

     

    37

     

     

     

    38

     

     

     

    113

     

     

     

    142

     

    Complera / Eviplera – Other International

     

     

    3

     

     

     

    2

     

     

     

    13

     

     

     

    14

     

     

     

     

    58

     

     

     

    69

     

     

     

    200

     

     

     

    258

     

     

     

     

     

     

     

     

     

     

    Descovy – U.S.

     

     

    479

     

     

     

    403

     

     

     

    1,631

     

     

     

    1,397

     

    Descovy – Europe

     

     

    26

     

     

     

    36

     

     

     

    118

     

     

     

    164

     

    Descovy – Other International

     

     

    31

     

     

     

    34

     

     

     

    123

     

     

     

    139

     

     

     

     

    537

     

     

     

    473

     

     

     

    1,872

     

     

     

    1,700

     

     

     

     

     

     

     

     

     

     

    Genvoya – U.S.

     

     

    543

     

     

     

    634

     

     

     

    1,983

     

     

     

    2,267

     

    Genvoya – Europe

     

     

    64

     

     

     

    85

     

     

     

    284

     

     

     

    391

     

    Genvoya – Other International

     

     

    33

     

     

     

    37

     

     

     

    136

     

     

     

    221

     

     

     

     

    640

     

     

     

    756

     

     

     

    2,404

     

     

     

    2,879

     

     

     

     

     

     

     

     

     

     

    Odefsey – U.S.

     

     

    295

     

     

     

    303

     

     

     

    1,058

     

     

     

    1,076

     

    Odefsey – Europe

     

     

    85

     

     

     

    104

     

     

     

    364

     

     

     

    440

     

    Odefsey – Other International

     

     

    11

     

     

     

    13

     

     

     

    47

     

     

     

    52

     

     

     

     

    392

     

     

     

    420

     

     

     

    1,469

     

     

     

    1,568

     

     

     

     

     

     

     

     

     

     

    Stribild – U.S.

     

     

    20

     

     

     

    38

     

     

     

    88

     

     

     

    132

     

    Stribild – Europe

     

     

    7

     

     

     

    10

     

     

     

    29

     

     

     

    43

     

    Stribild – Other International

     

     

    3

     

     

     

    2

     

     

     

    10

     

     

     

    14

     

     

     

     

    29

     

     

     

    50

     

     

     

    127

     

     

     

    189

     

     

     

     

     

     

     

     

     

     

    Truvada – U.S.

     

     

    37

     

     

     

    46

     

     

     

    113

     

     

     

    314

     

    Truvada – Europe

     

     

    3

     

     

     

    4

     

     

     

    15

     

     

     

    22

     

    Truvada – Other International

     

     

    5

     

     

     

    11

     

     

     

    18

     

     

     

    35

     

     

     

     

    45

     

     

     

    61

     

     

     

    147

     

     

     

    371

     

     

     

     

     

     

     

     

     

     

    Revenue share – Symtuza(1) – U.S.

     

     

    97

     

     

     

    94

     

     

     

    348

     

     

     

    355

     

    Revenue share – Symtuza(1) – Europe

     

     

    42

     

     

     

    40

     

     

     

    168

     

     

     

    165

     

    Revenue share – Symtuza(1) – Other International

     

     

    3

     

     

     

    3

     

     

     

    14

     

     

     

    11

     

     

     

     

    142

     

     

     

    137

     

     

     

    530

     

     

     

    531

     

     

     

     

     

     

     

     

     

     

    Other HIV(2) – U.S.

     

     

    4

     

     

     

    26

     

     

     

    15

     

     

     

    136

     

    Other HIV(2) – Europe

     

     

    5

     

     

     

    11

     

     

     

    24

     

     

     

    30

     

    Other HIV(2) – Other International

     

     

    3

     

     

     

    5

     

     

     

    17

     

     

     

    29

     

     

     

     

    12

     

     

     

    42

     

     

     

    57

     

     

     

    195

     

     

     

     

     

     

     

     

     

     

    Total HIV – U.S.

     

     

    3,914

     

     

     

    3,696

     

     

     

    13,820

     

     

     

    12,828

     

    Total HIV – Europe

     

     

    566

     

     

     

    590

     

     

     

    2,219

     

     

     

    2,366

     

    Total HIV – Other International

     

     

    293

     

     

     

    252

     

     

     

    1,155

     

     

     

    1,121

     

     

     

     

    4,772

     

     

     

    4,538

     

     

     

    17,194

     

     

     

    16,315

     

     

    GILEAD SCIENCES, INC.

    PRODUCT SALES SUMMARY - (Continued)

    (unaudited)

     

     

     

     

     

     

     

    Three Months Ended

     

    Twelve Months Ended

     

     

    December 31,

     

    December 31,

    (in millions)

     

    2022

     

    2021

     

    2022

     

    2021

    Veklury

     

     

     

     

     

     

     

     

    Veklury – U.S.

     

     

    395

     

     

     

    877

     

     

     

    1,575

     

     

     

    3,640

     

    Veklury – Europe

     

     

    142

     

     

     

    334

     

     

     

    702

     

     

     

    1,095

     

    Veklury – Other International

     

     

    462

     

     

     

    146

     

     

     

    1,628

     

     

     

    830

     

     

     

     

    1,000

     

     

     

    1,357

     

     

     

    3,905

     

     

     

    5,565

     

    HCV

     

     

     

     

     

     

     

     

    Ledipasvir / Sofosbuvir(3) – U.S.

     

     

    19

     

     

     

    21

     

     

     

    46

     

     

     

    84

     

    Ledipasvir / Sofosbuvir(3) – Europe

     

     

    4

     

     

     

    7

     

     

     

    17

     

     

     

    31

     

    Ledipasvir / Sofosbuvir(3) – Other International

     

     

    8

     

     

     

    21

     

     

     

    51

     

     

     

    97

     

     

     

     

    31

     

     

     

    49

     

     

     

    115

     

     

     

    212

     

     

     

     

     

     

     

     

     

     

    Sofosbuvir / Velpatasvir(4) – U.S.

     

     

    214

     

     

     

    166

     

     

     

    844

     

     

     

    815

     

    Sofosbuvir / Velpatasvir(4) – Europe

     

     

    67

     

     

     

    82

     

     

     

    355

     

     

     

    316

     

    Sofosbuvir / Velpatasvir(4) – Other International

     

     

    87

     

     

     

    59

     

     

     

    331

     

     

     

    331

     

     

     

     

    369

     

     

     

    307

     

     

     

    1,530

     

     

     

    1,462

     

     

     

     

     

     

     

     

     

     

    Other HCV(5) – U.S.

     

     

    27

     

     

     

    22

     

     

     

    115

     

     

     

    119

     

    Other HCV(5) – Europe

     

     

    9

     

     

     

    10

     

     

     

    40

     

     

     

    74

     

    Other HCV(5) – Other International

     

     

    3

     

     

     

    5

     

     

     

    10

     

     

     

    14

     

     

     

     

    39

     

     

     

    37

     

     

     

    166

     

     

     

    207

     

     

     

     

     

     

     

     

     

     

    Total HCV – U.S.

     

     

    260

     

     

     

    209

     

     

     

    1,005

     

     

     

    1,018

     

    Total HCV – Europe

     

     

    80

     

     

     

    99

     

     

     

    413

     

     

     

    421

     

    Total HCV – Other International

     

     

    98

     

     

     

    85

     

     

     

    392

     

     

     

    442

     

     

     

     

    439

     

     

     

    393

     

     

     

    1,810

     

     

     

    1,881

     

    HBV/HDV

     

     

     

     

     

     

     

     

    Vemlidy – U.S.

     

     

    123

     

     

     

    118

     

     

     

    429

     

     

     

    384

     

    Vemlidy – Europe

     

     

    8

     

     

     

    9

     

     

     

    35

     

     

     

    34

     

    Vemlidy – Other International

     

     

    89

     

     

     

    98

     

     

     

    379

     

     

     

    396

     

     

     

     

    220

     

     

     

    225

     

     

     

    842

     

     

     

    814

     

     

     

     

     

     

     

     

     

     

    Viread – U.S.

     

     

    2

     

     

     

    3

     

     

     

    6

     

     

     

    11

     

    Viread – Europe

     

     

    6

     

     

     

    6

     

     

     

    23

     

     

     

    28

     

    Viread – Other International

     

     

    14

     

     

     

    17

     

     

     

    62

     

     

     

    72

     

     

     

     

    22

     

     

     

    26

     

     

     

    91

     

     

     

    111

     

     

     

     

     

     

     

     

     

     

    Other HBV/HDV(6) – U.S.

     

     

    (1

    )

     

     

    1

     

     

     

     

     

     

    2

     

    Other HBV/HDV(6) – Europe

     

     

    14

     

     

     

    13

     

     

     

    55

     

     

     

    42

     

     

     

     

    13

     

     

     

    14

     

     

     

    55

     

     

     

    44

     

     

     

     

     

     

     

     

     

     

    Total HBV/HDV – U.S.

     

     

    124

     

     

     

    122

     

     

     

    435

     

     

     

    397

     

    Total HBV/HDV – Europe

     

     

    28

     

     

     

    28

     

     

     

    112

     

     

     

    104

     

    Total HBV/HDV – Other International

     

     

    103

     

     

     

    115

     

     

     

    441

     

     

     

    468

     

     

     

     

    255

     

     

     

    265

     

     

     

    988

     

     

     

    969

     

    Cell therapy

     

     

     

     

     

     

     

     

    Tecartus – U.S.

     

     

    61

     

     

     

    42

     

     

     

    221

     

     

     

    136

     

    Tecartus – Europe

     

     

    19

     

     

     

    15

     

     

     

    75

     

     

     

    40

     

    Tecartus – Other International

     

     

    1

     

     

     

     

     

     

    3

     

     

     

     

     

     

     

    82

     

     

     

    57

     

     

     

    299

     

     

     

    176

     

     

     

     

     

     

     

     

     

     

    Yescarta – U.S.

     

     

    219

     

     

     

    106

     

     

     

    747

     

     

     

    406

     

    Yescarta – Europe

     

     

    103

     

     

     

    65

     

     

     

    355

     

     

     

    253

     

    Yescarta – Other International

     

     

    15

     

     

     

    11

     

     

     

    57

     

     

     

    36

     

     

     

     

    337

     

     

     

    182

     

     

     

    1,160

     

     

     

    695

     

     

     

     

     

     

     

     

     

     

    Total cell therapy – U.S.

     

     

    281

     

     

     

    148

     

     

     

    968

     

     

     

    542

     

    Total cell therapy – Europe

     

     

    122

     

     

     

    80

     

     

     

    430

     

     

     

    293

     

    Total cell therapy – Other International

     

     

    17

     

     

     

    11

     

     

     

    60

     

     

     

    36

     

     

     

     

    419

     

     

     

    239

     

     

     

    1,459

     

     

     

    871

     

    GILEAD SCIENCES, INC.

    PRODUCT SALES SUMMARY - (Continued)

    (unaudited)

     

     

     

     

     

     

     

    Three Months Ended

     

    Twelve Months Ended

     

     

    December 31,

     

    December 31,

    (in millions)

     

    2022

     

    2021

     

    2022

     

    2021

    Trodelvy

     

     

     

     

     

     

     

     

    Trodelvy – U.S.

     

     

    146

     

     

     

    109

     

     

     

    525

     

     

     

    370

     

    Trodelvy – Europe

     

     

    44

     

     

     

    9

     

     

     

    143

     

     

     

    10

     

    Trodelvy – Other International

     

     

    4

     

     

     

     

     

     

    12

     

     

     

     

     

     

     

    195

     

     

     

    118

     

     

     

    680

     

     

     

    380

     

    Other

     

     

     

     

     

     

     

     

    AmBisome – U.S.

     

     

    9

     

     

     

    7

     

     

     

    57

     

     

     

    39

     

    AmBisome – Europe

     

     

    66

     

     

     

    72

     

     

     

    258

     

     

     

    274

     

    AmBisome – Other International

     

     

    42

     

     

     

    41

     

     

     

    182

     

     

     

    227

     

     

     

     

    117

     

     

     

    120

     

     

     

    497

     

     

     

    540

     

     

     

     

     

     

     

     

     

     

    Letairis – U.S.

     

     

    60

     

     

     

    49

     

     

     

    196

     

     

     

    206

     

     

     

     

     

     

     

     

     

     

    Other(7) – U.S.

     

     

    44

     

     

     

    27

     

     

     

    135

     

     

     

    136

     

    Other(7) – Europe

     

     

    13

     

     

     

    47

     

     

     

    65

     

     

     

    115

     

    Other(7) – Other International

     

     

    18

     

     

     

    7

     

     

     

    53

     

     

     

    30

     

     

     

     

    75

     

     

     

    81

     

     

     

    253

     

     

     

    281

     

     

     

     

     

     

     

     

     

     

    Total other – U.S.

     

     

    113

     

     

     

    83

     

     

     

    388

     

     

     

    381

     

    Total other – Europe

     

     

    79

     

     

     

    119

     

     

     

    323

     

     

     

    389

     

    Total other – Other International

     

     

    61

     

     

     

    48

     

     

     

    235

     

     

     

    257

     

     

     

     

    252

     

     

     

    250

     

     

     

    946

     

     

     

    1,027

     

     

     

     

     

     

     

     

     

     

    Total product sales – U.S.

     

     

    5,234

     

     

     

    5,244

     

     

     

    18,716

     

     

     

    19,176

     

    Total product sales – Europe

     

     

    1,061

     

     

     

    1,259

     

     

     

    4,342

     

     

     

    4,678

     

    Total product sales – Other International

     

     

    1,037

     

     

     

    657

     

     

     

    3,924

     

     

     

    3,154

     

     

     

    $

    7,333

     

     

    $

    7,160

     

     

    $

    26,982

     

     

    $

    27,008

     

    _______________________________

    (1)

    Represents Gilead’s revenue from cobicistat (“C”), FTC and TAF in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland Unlimited Company.

    (2)

    Includes Atripla, Emtriva, Sunlenca and Tybost.

    (3)

    Amounts consist of sales of Harvoni and the authorized generic version of Harvoni sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC.

    (4)

    Amounts consist of sales of Epclusa and the authorized generic version of Epclusa sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC.

    (5)

    Includes Vosevi and Sovaldi.

    (6)

    Includes Hepcludex and Hepsera.

    (7)

    Includes Cayston, Jyseleca, Ranexa and Zydelig.

     


    The Gilead Sciences Stock at the time of publication of the news with a fall of -4,05 % to 80,60EUR on Nasdaq stock exchange (02. Februar 2023, 21:31 Uhr).

    Business Wire (engl.)
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    Gilead Sciences Announces Fourth Quarter and Full Year 2022 Financial Results Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the fourth quarter and full year 2022. “2022 marked Gilead’s strongest full year growth in our base business since HCV sales peaked in 2015. This return to growth was …

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