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     325  0 Kommentare Gilead Sciences Announces First Quarter 2024 Financial Results

    Gilead Sciences, Inc. (Nasdaq: GILD) announced today its first quarter 2024 results of operations.

    “Gilead delivered another strong quarter of revenue growth in the first quarter with 6% year-over-year growth in our base business driven by HIV, Oncology and Liver Disease,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “The acquisition of CymaBay brings us another potentially transformative therapy for people with liver disease, and a regulatory decision on seladelpar is expected in August. New HIV data demonstrates the continued progress in our long-acting HIV pipeline, and we look forward to providing updates on this and our broad Oncology portfolio throughout the rest of 2024.”

    First Quarter 2024 Financial Results

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    • Total first quarter 2024 revenue increased 5% to $6.7 billion, compared to the same period in 2023, primarily due to higher HIV, Oncology and Liver Disease sales.
    • Diluted (loss) earnings per share (“EPS”) was $(3.34) in the first quarter 2024, compared to $0.80 in the same period in 2023. The decrease was primarily driven by an acquired in-process research and development (“IPR&D”) charge of $3.9 billion, or $3.14 per share, related to the acquisition of CymaBay Therapeutics, Inc. (“CymaBay”), as well as a pre-tax IPR&D impairment of $2.4 billion, or $1.46 per share, related to assets acquired by Gilead from Immunomedics, Inc. (“Immunomedics”) in 2020.
    • Non-GAAP diluted (loss) EPS was $(1.32) in the first quarter 2024, compared to $1.37 in the same period in 2023. The decrease was primarily driven by the charge related to the acquisition of CymaBay.
    • As of March 31, 2024, Gilead had $4.7 billion of cash, cash equivalents and marketable debt securities, compared to $8.4 billion as of December 31, 2023.
    • During the first quarter 2024, Gilead generated $2.2 billion in operating cash flow.
    • During the first quarter 2024, Gilead paid dividends of $990 million and repurchased $400 million of common stock.

    First Quarter 2024 Product Sales

    Total first quarter 2024 product sales increased 5% to $6.6 billion, compared to the same period in 2023. Total product sales, excluding Veklury, increased 6% to $6.1 billion in the first quarter 2024, compared to the same period in 2023, primarily due to higher sales in HIV, Oncology and Liver Disease.

    HIV product sales increased 4% to $4.3 billion in the first quarter 2024, compared to the same period in 2023, primarily driven by higher demand.

    • Biktarvy (bictegravir 50mg/emtricitabine 200mg (“FTC”)/tenofovir alafenamide 25mg (“TAF”)) sales increased 10% to $2.9 billion in the first quarter 2024, compared to the same period in 2023, primarily driven by higher demand in the United States, Europe and other international markets.
    • Descovy (FTC 200mg/TAF 25mg) sales decreased 5% to $426 million in the first quarter 2024, compared to the same period in 2023, primarily driven by lower average realized price due to channel mix, partially offset by higher demand.

    The Liver Disease portfolio sales increased 9% to $737 million in the first quarter 2024, compared to the same period in 2023. This was primarily driven by favorable inventory dynamics, the timing of chronic hepatitis C virus (“HCV”) purchases by the Department of Corrections in the United States, as well as higher demand across chronic hepatitis B virus (“HBV”), HCV and, in the European Union (“EU”), chronic hepatitis D virus (“HDV”).

    Veklury sales decreased 3% to $555 million in the first quarter 2024, compared to the same period in 2023, primarily driven by lower rates of COVID-19 related hospitalizations.

    Cell Therapy product sales increased 7% to $480 million in the first quarter 2024, compared to the same period in 2023.

    • Yescarta (axicabtagene ciloleucel) sales increased 6% to $380 million in the first quarter 2024, compared to the same period in 2023, primarily driven by strong demand in relapsed or refractory (“R/R”) large B-cell lymphoma (“LBCL”) outside the United States.
    • Tecartus (brexucabtagene autoleucel) sales increased 13% to $100 million in the first quarter 2024, compared to the same period in 2023, with increased demand in R/R adult acute lymphoblastic leukemia and R/R mantle cell lymphoma.

    Trodelvy (sacituzumab govitecan-hziy) sales increased 39% to $309 million in the first quarter 2024, compared to the same period in 2023, primarily driven by higher demand.

    First Quarter 2024 Product Gross Margin, Operating Expenses and Effective Tax Rate

    • Product gross margin was 76.6% in the first quarter 2024, compared to 77.8% in the same period in 2023, primarily driven by product mix and higher intangible asset amortization expenses. Non-GAAP product gross margin was 85.4% in the first quarter 2024, compared to 86.2% in the same period in 2023, primarily driven by product mix.
    • Research & development (“R&D”) expenses were $1.5 billion in the first quarter 2024, compared to $1.4 billion in the same period in 2023, primarily driven by costs related to the acquisition of CymaBay and restructuring expenses. Non-GAAP R&D expenses were $1.4 billion in the first quarter 2024, flat with the same period in 2023.
    • Acquired IPR&D expenses were $4.1 billion in the first quarter 2024, primarily driven by the $3.9 billion charge related to the acquisition of CymaBay that closed on March 22, 2024.
    • IPR&D impairment was $2.4 billion related to the assets acquired from Immunomedics in 2020 with no similar charges in 2023.
    • Selling, general and administrative (“SG&A”) expenses were $1.4 billion in the first quarter 2024, compared to $1.3 billion in the same period in 2023. This increase reflects costs related to the acquisition of CymaBay and restructuring expenses. Non-GAAP SG&A expenses were $1.3 billion in the first quarter 2024, flat with the same period in 2023.
    • The effective tax rate (“ETR”) was 7.0% in the first quarter 2024, compared to 24.3% in the same period in 2023, and non-GAAP ETR was (29.8)% in the first quarter 2024, compared to 18.9% in the same period in 2023. These changes primarily reflect the non-deductible acquired IPR&D charge for CymaBay.

    Guidance and Outlook

    For the full-year, Gilead expects:

    (in millions, except per share amounts)

     

    4/25/24 Guidance

     

     

    Low End

    High End

    Comparison to Prior Guidance

    Product sales

     

    $

    27,100

     

    $

    27,500

     

    Unchanged

    Product sales, excluding Veklury

     

    $

    25,800

     

    $

    26,200

     

    Unchanged

    Veklury

     

    $

    1,300

     

    $

    1,300

     

    Unchanged

    Diluted EPS

     

    $

    0.10

     

    $

    0.50

     

    Previously $5.15 to $5.55

    Non-GAAP diluted EPS

     

    $

    3.45

     

    $

    3.85

     

    Previously $6.85 to $7.25

    Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2024 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below.

    Key Updates Since Our Last Quarterly Release

    Virology

    • Presented data at the Conference on Retroviruses and Opportunistic Infections (“CROI”) across Gilead’s HIV long-acting treatment pipeline. For once-weekly oral dosing, this included Phase 2 data evaluating lenacapavir in combination with Merck & Co., Inc.’s islatravir as well as initial Phase 1b data for GS-1720, Gilead’s novel, investigational integrase inhibitor. Additionally, updated results were presented from the twice-yearly injectable Phase 1b study of lenacapavir in combination with investigational broadly neutralizing antibodies, teropavimab and zinlirvimab.
    • Announced data at CROI evaluating Biktarvy for treatment of people with HIV and coinfections of HBV or tuberculosis, as well as results from a Phase 2/3 study evaluating once-daily oral combination of bictegravir and lenacapavir.
    • Presented multiple real-world analyses at CROI supporting the use of Veklury for people hospitalized with COVID-19, including in immunocompromised people. Additionally, presented a real-world analysis evaluating the impact of Veklury on the risk of developing long-COVID.
    • Announced data at CROI evaluating the safety and efficacy of Hepcludex (bulevirtide) in people living with coinfections of HIV, HBV and HDV. In the United States and other areas outside of the EU and European Economic Area, bulevirtide is an investigational product and its safety and efficacy have not been established.
    • Received approval by the U.S. Food and Drug Administration (“FDA”) to expand Biktarvy’s label to include treatment of people with HIV who have suppressed viral loads with known or suspected M184V/I resistance.
    • Received approval from FDA to expand the indication for Vemlidy (tenofovir alafenamide) to include treatment of chronic HBV in children six years and older who weigh at least 25 kg with compensated liver disease.

    Oncology

    • Announced a research collaboration, option and license agreement with Merus N.V. (“Merus”) to discover novel antibody-based trispecific T-cell engagers in oncology.
    • Entered into an exclusive license agreement with Xilio Therapeutics, Inc. (“Xilio”) to develop and commercialize Xilio’s tumor-activated IL-12 program, including investigational candidate XTX301 in advanced solid tumors.

    Inflammation

    • Completed the acquisition of CymaBay for $4.3 billion in total equity value, or $3.9 billion net cash paid, adding investigational candidate seladelpar for the treatment of primary biliary cholangitis (“PBC”) to Gilead’s Liver Disease portfolio. Seladelpar is an investigational, oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist, with Orphan Drug Designation in the United States and Europe. PPARδ has been shown to regulate critical metabolic and liver disease pathways. FDA accepted the New Drug Application for seladelpar in February 2024 for priority review, with a Prescription Drug User Fee Act target action date of August 14, 2024.

    Corporate

    • Announced that Kevin Lofton is retiring from Gilead’s Board of Directors (the “Board”), effective at the conclusion of the Annual Meeting of Stockholders (“Annual Meeting”) on May 8, 2024. Anthony Welters, if re-elected at the Annual Meeting, will succeed Mr. Lofton as Lead Independent Director.
    • Recognized as one of America’s Most JUST Companies by Just Capital and CNBC, reflecting Gilead’s longstanding commitment to operate responsibly.
    • The Board declared a quarterly dividend of $0.77 per share of common stock for the second quarter of 2024. The dividend is payable on June 27, 2024, to stockholders of record at the close of business on June 14, 2024. Future dividends will be subject to Board approval.

    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.

    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, COVID-19 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: Gilead’s ability to achieve its anticipated full year 2024 financial results, including as a result of the uncertainty of the amount and timing of Veklury revenues; Gilead’s ability to make progress on any of its long-term ambitions or 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 the arrangements with CymaBay, Merus, and Xilio; 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 Biktarvy, Hepcludex, Veklury, GS-1720, lenacapavir, seladelpar, teropavimab, XTX301, and zinlirvimab, 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 FDA approval of the New Drug Application for seladelpar, 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; 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 Gilead’s products over other therapies and may therefore be reluctant to prescribe the products, including Biktarvy and Vemlidy; 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 March 31, 2024 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, KITETM, AMBISOME, ATRIPLA, BIKTARVY, CAYSTON, COMPLERA, DESCOVY, DESCOVY FOR PREP, EMTRIVA, EPCLUSA, EVIPLERA, GENVOYA, HARVONI, HEPCLUDEX, HEPSERA, JYSELECA, LETAIRIS, ODEFSEY, SOVALDI, STRIBILD, SUNLENCA , TECARTUS, TRODELVY, TRUVADA, TRUVADA FOR PREP, TYBOST, VEKLURY, VEMLIDY, VIREAD, VOSEVI, YESCARTA and ZYDELIG. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, United States. Other trademarks are the property of their respective owners.

    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 OPERATIONS

    (unaudited)

     

     

     

    Three Months Ended

     

     

    March 31,

    (in millions, except per share amounts)

     

     

    2024

     

     

     

    2023

     

    Revenues:

     

     

     

     

    Product sales

     

    $

    6,647

     

     

    $

    6,306

     

    Royalty, contract and other revenues

     

     

    39

     

     

     

    46

     

    Total revenues

     

     

    6,686

     

     

     

    6,352

     

    Costs and expenses:

     

     

     

     

    Cost of goods sold

     

     

    1,552

     

     

     

    1,401

     

    Research and development expenses

     

     

    1,520

     

     

     

    1,447

     

    Acquired in-process research and development expenses

     

     

    4,131

     

     

     

    481

     

    In-process research and development impairment

     

     

    2,430

     

     

     

     

    Selling, general and administrative expenses

     

     

    1,375

     

     

     

    1,319

     

    Total costs and expenses

     

     

    11,008

     

     

     

    4,647

     

    Operating (loss) income

     

     

    (4,322

    )

     

     

    1,705

     

    Interest expense

     

     

    254

     

     

     

    230

     

    Other (income) expense, net

     

     

    (91

    )

     

     

    174

     

    (Loss) income before income taxes

     

     

    (4,486

    )

     

     

    1,300

     

    Income tax (benefit) expense

     

     

    (315

    )

     

     

    316

     

    Net (loss) income

     

     

    (4,170

    )

     

     

    985

     

    Net loss attributable to noncontrolling interest

     

     

     

     

     

    (26

    )

    Net (loss) income attributable to Gilead

     

    $

    (4,170

    )

     

    $

    1,010

     

    Basic (loss) earnings per share attributable to Gilead

     

    $

    (3.34

    )

     

    $

    0.81

     

    Shares used in basic (loss) earnings per share attributable to Gilead calculation

     

     

    1,247

     

     

     

    1,248

     

    Diluted (loss) earnings per share attributable to Gilead

     

    $

    (3.34

    )

     

    $

    0.80

     

    Shares used in diluted (loss) earnings per share attributable to Gilead calculation

     

     

    1,247

     

     

     

    1,261

     

    Cash dividends declared per share

     

    $

    0.77

     

     

    $

    0.75

     

     

     

     

     

     

    Research and development expenses as a % of revenues

     

     

    22.7

    %

     

     

    22.8

    %

    Selling, general and administrative expenses as a % of revenues

     

     

    20.6

    %

     

     

    20.8

    %

    Effective tax rate

     

     

    7.0

    %

     

     

    24.3

    %

     

    GILEAD SCIENCES, INC.

    TOTAL REVENUE SUMMARY

    (unaudited)

     

     

     

    Three Months Ended

     

     

     

     

     

    March 31,

     

     

     

    (in millions, except percentages)

     

     

    2024

     

     

    2023

     

    Change

     

    Product sales:

     

     

     

     

     

     

     

    HIV

     

    $

    4,342

     

    $

    4,190

     

    4

    %

     

    Liver Disease

     

     

    737

     

     

    675

     

    9

    %

     

    Oncology

     

     

    789

     

     

    670

     

    18

    %

     

    Other

     

     

    224

     

     

    199

     

    13

    %

     

    Total product sales excluding Veklury

     

     

    6,092

     

     

    5,733

     

    6

    %

     

    Veklury

     

     

    555

     

     

    573

     

    (3

    )%

     

    Total product sales

     

     

    6,647

     

     

    6,306

     

    5

    %

     

    Royalty, contract and other revenues

     

     

    39

     

     

    46

     

    (15

    )%

     

    Total revenues

     

    $

    6,686

     

    $

    6,352

     

    5

    %

     

     

    GILEAD SCIENCES, INC.

    NON-GAAP FINANCIAL INFORMATION(1)

    (unaudited)

     

     

     

    Three Months Ended

     

     

     

     

    March 31,

     

     

    (in millions, except percentages)

     

     

    2024

     

     

     

    2023

     

     

    Change

    Non-GAAP:

     

     

     

     

     

     

    Cost of goods sold

     

    $

    974

     

     

    $

    871

     

     

    12

    %

    Research and development expenses

     

    $

    1,403

     

     

    $

    1,439

     

     

    (2

    )%

    Acquired IPR&D expenses(2)

     

    $

    4,131

     

     

    $

    481

     

     

    NM

     

    Selling, general and administrative expenses

     

    $

    1,295

     

     

    $

    1,318

     

     

    (2

    )%

    Other (income) expense, net

     

    $

    (104

    )

     

    $

    (82

    )

     

    27

    %

    Diluted (loss) earnings per share attributable to Gilead

     

    $

    (1.32

    )

     

    $

    1.37

     

     

    NM

     

     

     

     

     

     

     

     

    Product gross margin

     

     

    85.4

    %

     

     

    86.2

    %

     

    -83 bps

    Research and development expenses as a % of revenues

     

     

    21.0

    %

     

     

    22.6

    %

     

    -166 bps

    Selling, general and administrative expenses as a % of revenues

     

     

    19.4

    %

     

     

    20.7

    %

     

    -138 bps

    Operating margin

     

     

    (16.7

    )%

     

     

    35.3

    %

     

    NM

     

    Effective tax rate

     

     

    (29.8

    )%

     

     

    18.9

    %

     

    NM

     

    ________________________________
    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 below.

    (2)

    Equal to GAAP financial information.

     

    GILEAD SCIENCES, INC.

    RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION

    (unaudited)

     

     

     

    Three Months Ended

     

     

    March 31,

    (in millions, except percentages and per share amounts)

     

     

    2024

     

     

     

    2023

     

    Cost of goods sold reconciliation:

     

     

     

     

    GAAP cost of goods sold

     

    $

    1,552

     

     

    $

    1,401

     

    Acquisition-related – amortization(1)

     

     

    (579

    )

     

     

    (530

    )

    Non-GAAP cost of goods sold

     

    $

    974

     

     

    $

    871

     

     

     

     

     

     

    Product gross margin reconciliation:

     

     

     

     

    GAAP product gross margin

     

     

    76.6

    %

     

     

    77.8

    %

    Acquisition-related – amortization(1)

     

     

    8.7

    %

     

     

    8.4

    %

    Non-GAAP product gross margin

     

     

    85.4

    %

     

     

    86.2

    %

     

     

     

     

     

    Research and development expenses reconciliation:

     

     

     

     

    GAAP research and development expenses

     

    $

    1,520

     

     

    $

    1,447

     

    Acquisition-related – other costs(2)

     

     

    (66

    )

     

     

    (8

    )

    Restructuring

     

     

    (50

    )

     

     

     

    Non-GAAP research and development expenses

     

    $

    1,403

     

     

    $

    1,439

     

     

     

     

     

     

    IPR&D impairment reconciliation:

     

     

     

     

    GAAP IPR&D impairment

     

    $

    2,430

     

     

    $

     

    IPR&D impairment

     

     

    (2,430

    )

     

     

     

    Non-GAAP IPR&D impairment

     

    $

     

     

    $

     

     

     

     

     

     

    Selling, general and administrative expenses reconciliation:

     

     

     

     

    GAAP selling, general and administrative expenses

     

    $

    1,375

     

     

    $

    1,319

     

    Acquisition-related – other costs(2)

     

     

    (67

    )

     

     

    (1

    )

    Restructuring

     

     

    (13

    )

     

     

     

    Non-GAAP selling, general and administrative expenses

     

    $

    1,295

     

     

    $

    1,318

     

     

     

     

     

     

    Operating (loss) income reconciliation:

     

     

     

     

    GAAP operating (loss) income

     

    $

    (4,322

    )

     

    $

    1,705

     

    Acquisition-related – amortization(1)

     

     

    579

     

     

     

    530

     

    Acquisition-related – other costs(2)

     

     

    133

     

     

     

    9

     

    Restructuring

     

     

    63

     

     

     

     

    IPR&D impairment

     

     

    2,430

     

     

     

     

    Non-GAAP operating (loss) income

     

    $

    (1,117

    )

     

    $

    2,243

     

     

     

     

     

     

    Operating margin reconciliation:

     

     

     

     

    GAAP operating margin

     

     

    (64.6

    )%

     

     

    26.8

    %

    Acquisition-related – amortization(1)

     

     

    8.7

    %

     

     

    8.3

    %

    Acquisition-related – other costs(2)

     

     

    2.0

    %

     

     

    0.1

    %

    Restructuring

     

     

    0.9

    %

     

     

    %

    IPR&D impairment

     

     

    36.3

    %

     

     

    %

    Non-GAAP operating margin

     

     

    (16.7

    )%

     

     

    35.3

    %

     

     

     

     

     

    Other (income) expense, net reconciliation:

     

     

     

     

    GAAP other (income) expense, net

     

    $

    (91

    )

     

    $

    174

     

    Loss from equity securities, net

     

     

    (14

    )

     

     

    (256

    )

    Non-GAAP other (income) expense, net

     

    $

    (104

    )

     

    $

    (82

    )

     

     

     

     

     

    GILEAD SCIENCES, INC.

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

    (unaudited)

     

     

     

    Three Months Ended

     

     

    March 31,

    (in millions, except percentages and per share amounts)

     

     

    2024

     

     

     

    2023

     

    Effective tax rate and income tax (benefit) expense reconciliation:

     

     

     

     

    GAAP effective tax rate

     

     

    7.0

    %

     

     

    24.3

    %

     

     

     

     

     

    GAAP income tax (benefit) expense

     

    $

    (315

    )

     

    $

    316

     

    Income tax effect of non-GAAP adjustments:

     

     

     

     

    Acquisition-related – amortization(1)

     

     

    121

     

     

     

    107

     

    Acquisition-related – other costs(2)

     

     

    30

     

     

     

    3

     

    Restructuring

     

     

    10

     

     

     

     

    IPR&D impairment

     

     

    611

     

     

     

     

    Loss from equity securities, net

     

     

    (39

    )

     

     

    (1

    )

    Discrete and related tax charges(3)

     

     

    (39

    )

     

     

    (29

    )

    Non-GAAP income tax expense

     

    $

    379

     

     

    $

    396

     

     

     

     

     

     

    Non-GAAP effective tax rate

     

     

    (29.8

    )%

     

     

    18.9

    %

     

     

     

     

     

    Net (loss) income attributable to Gilead reconciliation:

     

     

     

     

    GAAP net (loss) income attributable to Gilead

     

    $

    (4,170

    )

     

    $

    1,010

     

    Acquisition-related – amortization(1)

     

     

    458

     

     

     

    422

     

    Acquisition-related – other costs(2)

     

     

    103

     

     

     

    6

     

    Restructuring

     

     

    54

     

     

     

     

    IPR&D impairment

     

     

    1,819

     

     

     

     

    Loss from equity securities, net

     

     

    53

     

     

     

    257

     

    Discrete and related tax charges(3)

     

     

    39

     

     

     

    29

     

    Non-GAAP net (loss) income attributable to Gilead

     

    $

    (1,644

    )

     

    $

    1,725

     

     

     

     

     

     

    Diluted (loss) earnings per share reconciliation:

     

     

     

     

    GAAP diluted (loss) earnings per share

     

    $

    (3.34

    )

     

    $

    0.80

     

    Acquisition-related – amortization(1)

     

     

    0.37

     

     

     

    0.33

     

    Acquisition-related – other costs(2)

     

     

    0.08

     

     

     

    0.01

     

    Restructuring

     

     

    0.04

     

     

     

     

    IPR&D impairment

     

     

    1.46

     

     

     

     

    Loss from equity securities, net

     

     

    0.04

     

     

     

    0.20

     

    Discrete and related tax charges(3)

     

     

    0.03

     

     

     

    0.02

     

    Non-GAAP diluted (loss) earnings per share

     

    $

    (1.32

    )

     

    $

    1.37

     

     

     

     

     

     

    Non-GAAP adjustment summary:

     

     

     

     

    Cost of goods sold adjustments

     

    $

    579

     

     

    $

    530

     

    Research and development expenses adjustments

     

     

    117

     

     

     

    8

     

    IPR&D impairment adjustments

     

     

    2,430

     

     

     

     

    Selling, general and administrative expenses adjustments

     

     

    80

     

     

     

    1

     

    Total non-GAAP adjustments to costs and expenses

     

     

    3,205

     

     

     

    539

     

    Other (income) expense, net adjustments

     

     

    14

     

     

     

    256

     

    Total non-GAAP adjustments before income taxes

     

     

    3,219

     

     

     

    795

     

    Income tax effect of non-GAAP adjustments above

     

     

    (732

    )

     

     

    (109

    )

    Discrete and related tax charges(3)

     

     

    39

     

     

     

    29

     

    Total non-GAAP adjustments to net income attributable to Gilead

     

    $

    2,526

     

     

    $

    715

     

    ______________________________

    (1)

    Relates to amortization of acquired intangibles and inventory step-up charges.

    (2)

    Adjustments include integration expenses, contingent consideration fair value adjustments and other expenses associated with Gilead’s acquisitions of MYR GmbH, MiroBio, Ltd., Tmunity Therapeutics, Inc. and CymaBay Therapeutics, Inc.

    (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 2024 FULL-YEAR GUIDANCE(1)

    (unaudited)

     

     

     

     

     

    (in millions, except percentages and per share amounts)

     

    Provided

    February 6, 2024

     

    Updated

    April 25, 2024

    Projected product gross margin GAAP to non-GAAP reconciliation:

     

     

     

     

    GAAP projected product gross margin

     

    76.0% - 77.0%

     

    76.0% - 77.0%

    Acquisition-related expenses

     

    ~ 9.0%

     

    ~ 9.0%

    Non-GAAP projected product gross margin

     

    85.0% - 86.0%

     

    85.0% - 86.0%

     

     

     

     

     

    Projected operating income GAAP to non-GAAP reconciliation:

     

     

     

     

    GAAP projected operating income

     

    $8,700 - $9,200

     

    $1,900 - $2,400

    IPR&D impairment, acquisition-related and restructuring expenses

     

    ~ 2,500

     

    ~ 5,100

    Non-GAAP projected operating income

     

    $11,200 - $11,700

     

    $7,000 - $7,500

     

     

     

     

     

    Projected effective tax rate GAAP to non-GAAP reconciliation:

     

     

     

     

    GAAP projected effective tax rate

     

    ~ 21%

     

    ~ 65%

    Income tax effect of above non-GAAP adjustments and fair value adjustments of equity securities, and discrete and related tax adjustments

     

    (~ 2%)

     

    (~ 35%)

    Non-GAAP projected effective tax rate

     

    ~ 19%

     

    ~ 30%

     

     

     

     

     

    Projected diluted EPS GAAP to non-GAAP reconciliation:

     

     

     

     

    GAAP projected diluted EPS

     

    $5.15 - $5.55

     

    $0.10 - $0.50

    IPR&D impairment, acquisition-related and restructuring expenses, fair value adjustments of equity securities and discrete and related tax adjustments

     

    ~ 1.70

     

    ~ 3.35

    Non-GAAP projected diluted EPS

     

    $6.85 - $7.25

     

    $3.45 - $3.85

    ________________________________

    (1)

    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. The non-GAAP 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.

     

    GILEAD SCIENCES, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (unaudited)

     

     

     

    March 31,

     

    December 31,

    (in millions)

     

    2024

     

    2023

    Assets

     

     

     

     

    Cash, cash equivalents and marketable debt securities

     

    $

    4,718

     

    $

    8,428

    Accounts receivable, net

     

     

    4,669

     

     

    4,660

    Inventories

     

     

    3,363

     

     

    3,366

    Property, plant and equipment, net

     

     

    5,321

     

     

    5,317

    Intangible assets, net

     

     

    23,428

     

     

    26,454

    Goodwill

     

     

    8,314

     

     

    8,314

    Other assets

     

     

    6,479

     

     

    5,586

    Total assets

     

    $

    56,292

     

    $

    62,125

    Liabilities and Stockholders’ Equity

     

     

     

     

    Current liabilities

     

    $

    13,015

     

    $

    11,280

    Long-term liabilities

     

     

    25,822

     

     

    28,096

    Stockholders’ equity(1)

     

     

    17,455

     

     

    22,749

    Total liabilities and stockholders’ equity

     

    $

    56,292

     

    $

    62,125

    ________________________________

    (1)

    As of March 31, 2024 and December 31, 2023, there were 1,246 shares of common stock issued and outstanding.

     

    GILEAD SCIENCES, INC.

    SELECTED CASH FLOW INFORMATION

    (unaudited)

     

     

     

    Three Months Ended

     

     

    March 31,

    (in millions)

     

     

    2024

     

     

     

    2023

     

    Net cash provided by operating activities

     

    $

    2,219

     

     

    $

    1,744

     

    Net cash used in investing activities

     

     

    (2,207

    )

     

     

    (826

    )

    Net cash used in financing activities

     

     

    (1,361

    )

     

     

    (1,406

    )

    Effect of exchange rate changes on cash and cash equivalents

     

     

    (18

    )

     

     

    13

     

    Net change in cash and cash equivalents

     

     

    (1,367

    )

     

     

    (476

    )

    Cash and cash equivalents at beginning of period

     

     

    6,085

     

     

     

    5,412

     

    Cash and cash equivalents at end of period

     

    $

    4,718

     

     

    $

    4,936

     

     

     

    Three Months Ended

     

     

    March 31,

    (in millions)

     

     

    2024

     

     

     

    2023

     

    Net cash provided by operating activities

     

    $

    2,219

     

     

    $

    1,744

     

    Capital expenditures

     

     

    (105

    )

     

     

    (109

    )

    Free cash flow(1)

     

    $

    2,114

     

     

    $

    1,635

     

    ________________________________

    (1)

    Free cash flow is a non-GAAP liquidity measure. Please refer to our disclosures in the Non-GAAP Financial Information section above.

     

    GILEAD SCIENCES, INC.

    PRODUCT SALES SUMMARY

    (unaudited)

     

     

     

    Three Months Ended

     

     

    March 31,

    (in millions)

     

     

    2024

     

     

    2023

    HIV

     

     

     

     

    Biktarvy – U.S.

     

    $

    2,315

     

    $

    2,161

    Biktarvy – Europe

     

     

    365

     

     

    304

    Biktarvy – Rest of World

     

     

    265

     

     

    212

     

     

     

    2,946

     

     

    2,677

     

     

     

     

     

    Descovy – U.S.

     

     

    371

     

     

    395

    Descovy – Europe

     

     

    26

     

     

    25

    Descovy – Rest of World

     

     

    29

     

     

    29

     

     

     

    426

     

     

    449

     

     

     

     

     

    Genvoya – U.S.

     

     

    332

     

     

    417

    Genvoya – Europe

     

     

    49

     

     

    55

    Genvoya – Rest of World

     

     

    21

     

     

    29

     

     

     

    403

     

     

    501

     

     

     

     

     

    Odefsey – U.S.

     

     

    223

     

     

    230

    Odefsey – Europe

     

     

    76

     

     

    76

    Odefsey – Rest of World

     

     

    11

     

     

    11

     

     

     

    310

     

     

    317

     

     

     

     

     

    Symtuza - Revenue share(1) – U.S.

     

     

    104

     

     

    98

    Symtuza - Revenue share(1) – Europe

     

     

    33

     

     

    36

    Symtuza - Revenue share(1) – Rest of World

     

     

    3

     

     

    4

     

     

     

    141

     

     

    138

     

     

     

     

     

    Other HIV(2) – U.S.

     

     

    60

     

     

    62

    Other HIV(2) – Europe

     

     

    45

     

     

    32

    Other HIV(2) – Rest of World

     

     

    12

     

     

    13

     

     

     

    117

     

     

    108

     

     

     

     

     

    Total HIV – U.S.

     

     

    3,405

     

     

    3,364

    Total HIV – Europe

     

     

    596

     

     

    528

    Total HIV – Rest of World

     

     

    342

     

     

    298

     

     

     

    4,342

     

     

    4,190

    Liver Disease

     

     

     

     

    Sofosbuvir / Velpatasvir(3) – U.S.

     

     

    248

     

     

    204

    Sofosbuvir / Velpatasvir(3) – Europe

     

     

    79

     

     

    90

    Sofosbuvir / Velpatasvir(3) – Rest of World

     

     

    78

     

     

    90

     

     

     

    405

     

     

    385

     

     

     

     

     

    Vemlidy – U.S.

     

     

    95

     

     

    87

    Vemlidy – Europe

     

     

    11

     

     

    9

    Vemlidy – Rest of World

     

     

    119

     

     

    103

     

     

     

    225

     

     

    199

     

     

     

     

     

    Other Liver Disease(4) – U.S.

     

     

    42

     

     

    27

    Other Liver Disease(4) – Europe

     

     

    47

     

     

    41

    Other Liver Disease(4) – Rest of World

     

     

    19

     

     

    23

     

     

     

    107

     

     

    91

     

     

     

     

     

    Total Liver Disease – U.S.

     

     

    385

     

     

    318

    Total Liver Disease – Europe

     

     

    137

     

     

    140

    Total Liver Disease – Rest of World

     

     

    215

     

     

    217

     

     

     

    737

     

     

    675

     

     

     

     

     

    Veklury

     

     

     

     

    Veklury – U.S.

     

     

    315

     

     

    252

    Veklury – Europe

     

     

    70

     

     

    111

    Veklury – Rest of World

     

     

    169

     

     

    209

     

     

     

    555

     

     

    573

     

    GILEAD SCIENCES, INC.

    PRODUCT SALES SUMMARY - (Continued)

    (unaudited)

     

     

     

    Three Months Ended

     

     

    March 31,

    (in millions)

     

     

    2024

     

     

    2023

    Oncology

     

     

     

     

    Cell Therapy

     

     

     

     

    Tecartus – U.S.

     

     

    55

     

     

    59

    Tecartus – Europe

     

     

    36

     

     

    27

    Tecartus – Rest of World

     

     

    8

     

     

    3

     

     

     

    100

     

     

    89

     

     

     

     

     

    Yescarta – U.S.

     

     

    170

     

     

    210

    Yescarta – Europe

     

     

    158

     

     

    121

    Yescarta – Rest of World

     

     

    52

     

     

    28

     

     

     

    380

     

     

    359

     

     

     

     

     

    Total Cell Therapy – U.S.

     

     

    225

     

     

    269

    Total Cell Therapy – Europe

     

     

    195

     

     

    148

    Total Cell Therapy – Rest of World

     

     

    60

     

     

    31

     

     

     

    480

     

     

    448

    Trodelvy

     

     

     

     

    Trodelvy – U.S.

     

     

    206

     

     

    162

    Trodelvy – Europe

     

     

    68

     

     

    54

    Trodelvy – Rest of World

     

     

    36

     

     

    6

     

     

     

    309

     

     

    222

     

     

     

     

     

    Total Oncology – U.S.

     

     

    431

     

     

    431

    Total Oncology – Europe

     

     

    262

     

     

    202

    Total Oncology – Rest of World

     

     

    96

     

     

    37

     

     

     

    789

     

     

    670

    Other

     

     

     

     

    AmBisome – U.S.

     

     

    14

     

     

    6

    AmBisome – Europe

     

     

    70

     

     

    60

    AmBisome – Rest of World

     

     

    60

     

     

    49

     

     

     

    144

     

     

    116

     

     

     

     

     

    Other(5) – U.S.

     

     

    59

     

     

    62

    Other(5) – Europe

     

     

    9

     

     

    12

    Other(5) – Rest of World

     

     

    12

     

     

    9

     

     

     

    80

     

     

    83

     

     

     

     

     

    Total Other – U.S.

     

     

    73

     

     

    69

    Total Other – Europe

     

     

    79

     

     

    72

    Total Other – Rest of World

     

     

    71

     

     

    58

     

     

     

    224

     

     

    199

     

     

     

     

     

    Total product sales – U.S.

     

     

    4,609

     

     

    4,434

    Total product sales – Europe

     

     

    1,144

     

     

    1,053

    Total product sales – Rest of World

     

     

    894

     

     

    819

     

     

    $

    6,647

     

    $

    6,306

    ______________________________

    (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, Complera/Eviplera, Emtriva, Sunlenca, Stribild, Truvada and Tybost.

    (3)

    Includes Epclusa and the authorized generic version of Epclusa sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC (“Asegua”).

    (4)

    Includes ledipasvir/sofosbuvir (Harvoni and the authorized generic version of Harvoni sold by Asegua), Hepcludex, Hepsera, Sovaldi, Viread and Vosevi.

    (5)

    Includes Cayston, Jyseleca, Letairis, Ranexa and Zydelig.

     


    The Gilead Sciences Stock at the time of publication of the news with a fall of -2,90 % to 65,14EUR on Nasdaq stock exchange (25. April 2024, 21:50 Uhr).

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    Gilead Sciences Announces First Quarter 2024 Financial Results Gilead Sciences, Inc. (Nasdaq: GILD) announced today its first quarter 2024 results of operations. “Gilead delivered another strong quarter of revenue growth in the first quarter with 6% year-over-year growth in our base business driven by HIV, …

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