GILD · GILEAD SCIENCES, INC.

317 filings

8-K

GILD 8-K Current Reports

GILEAD SCIENCES, INC. - 317 current reports

Filing record · 2016–202610-K1210-Q328-K117

Showing 1-50 of 317 filings

8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Aug 4, 2026)

Gilead Sciences reported second-quarter 2026 results on August 4, 2026, with total revenues up 10% year-over-year to $7.8 billion and product sales excluding Veklury up 10% to $7.6 billion. The core business showed strength, led by HIV products (up 12% to $5.7 billion, with Biktarvy up 7% to $3.8 billion and Descovy up 48% to $967 million), Trodelvy (up 26% to $457 million), and Livdelzi. Non-GAAP product gross margin held flat at 86.9%, and non-GAAP SG&A rose 12% on HIV promotional spending. Management raised its full-year product sales guidance to $30.1-30.4 billion and narrowed its non-GAAP diluted loss per share guidance to $(0.65) to $(0.30), from $(1.05) to $(0.65) previously. Headline GAAP results were deeply negative, with diluted loss per share of $(8.45) versus $1.56 a year earlier. This was driven by $11.2 billion of acquired IPR&D expense tied to the Arcellx, Tubulis and Ouro Medicines acquisitions, equal to about $9.08 per share, plus a $1.75 billion IPR&D impairment on assets from Immunomedics. The acquisitions also pushed the effective tax rate negative, because the acquired IPR&D is not tax-deductible. Liquidity fell sharply: cash and marketable debt securities dropped to $3.2 billion from $10.6 billion at year-end 2025, after $11.3 billion of acquisition outflows, and the company funded this partly with $4.1 billion of net new debt. Stockholders' equity fell to $11.7 billion from $22.6 billion. The quarter's key tension is between a healthy base business and a balance sheet and GAAP earnings profile reshaped by large, costly pipeline acquisitions. Investors will likely focus on whether the acquired assets (anito-cel, Tubulis ADCs, gamgertamig) justify the spending, on the Veklury decline (down 81% in the quarter), on the EVOKE-03 discontinuation, and on the pace of deleveraging. The company also declared a $0.82 quarterly dividend for the third quarter.

Aug 4, 2026 8-K

Material AgreementsFinancial EventsOther Events+1

GILEAD SCIENCES, INC. 8-K Report, Material Agreement (May 20, 2026)

Gilead Sciences, Inc. (GILD) has filed an 8-K to report the entry into a material definitive agreement related to the issuance of $3 billion in aggregate principal amount of senior notes. This issuance, structured across four series with varying maturity dates (2028, 2029, 2031, and 2034) and interest rates ranging from 4.250% to 4.900%, was conducted through a public offering under a previously filed Form S-3 registration statement. The company intends to utilize the net proceeds for general corporate purposes, including potential acquisitions, investments, and strategic transactions, signaling a proactive approach to funding future growth and operational flexibility. The filing also incorporates the underwriting agreement with major financial institutions acting as representatives for the underwriters. Investors should note that while this issuance provides capital, it also increases Gilead's debt obligations and introduces specific covenants and restrictions detailed within the supplemental indenture, such as limitations on secured indebtedness and obligations to repurchase notes upon certain change of control events. The specific redemption prices for the notes are available in their respective forms, which are attached as exhibits to this filing.

May 20, 2026 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (May 7, 2026)

Gilead Sciences reported first quarter 2026 results that were strong at the operating level, with total revenues up 4% to $7.0 billion and product sales excluding Veklury up 8% to $6.8 billion, led by HIV (up 10% to $5.0 billion, with Biktarvy at $3.4 billion and Descovy up 38%) and Trodelvy (up 37% to $402 million). Non-GAAP diluted EPS rose 12% to $2.03, and non-GAAP operating margin expanded to 46.9% from 43.4%, helped by a higher product gross margin (87.5% non-GAAP) following the expiration of a royalty-related obligation. Veklury sales fell 52% as COVID-19 hospitalizations declined, and Cell Therapy sales fell 12% amid competition. GAAP diluted EPS of $1.61 benefited from $142 million of net gains on equity securities versus losses a year earlier. The most consequential item for investors is the guidance change. Gilead raised full-year 2026 product sales guidance to $30.0-30.4 billion, but cut GAAP diluted EPS guidance to a loss of $(3.25) to $(2.85) from $6.75-7.15, and non-GAAP EPS guidance to $(1.05) to $(0.65) from $8.45-8.85. The reduction, about $9.50 per share, reflects anticipated acquired IPR&D charges of roughly $11.5 billion tied to the Arcellx ($7.8 billion equity value, now completed), Ouro, and Tubulis acquisitions, plus associated financing costs. These are largely non-cash, one-time charges, but they materially change reported earnings for 2026. Balance sheet and liquidity moved meaningfully in the quarter. Cash and marketable securities fell to $8.6 billion from $10.6 billion after $2.8 billion of debt repayments, $1.0 billion of dividends and $419 million of buybacks, while operating cash flow was $2.5 billion. Management also highlighted regulatory catalysts ahead, including a BIC/LEN PDUFA date of August 27, 2026, and an anito-cel PDUFA date of December 23, 2026. The quarterly dividend was declared at $0.82 per share.

May 7, 2026 8-K

Shareholder MattersExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Shareholder Vote Results (May 4, 2026)

Gilead Sciences, Inc. (GILD) has filed an 8-K detailing the outcomes of its 2026 annual meeting of stockholders held on April 30, 2026. The meeting saw a strong turnout, with approximately 91% of outstanding shares represented, establishing a quorum. Key outcomes include the re-election of all nine director nominees, with overwhelming support across the board. Stockholders also ratified the appointment of Ernst & Young LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2026, and approved, on an advisory basis, the compensation of the company's Named Executive Officers. Furthermore, investors approved the amended and restated Gilead Sciences, Inc. 2022 Equity Incentive Plan, indicating continued support for executive and employee long-term incentives. However, several significant stockholder proposals did not receive majority approval, including those requesting an independent Board Chair, a report on the impact of extended patent exclusivities on patient access, and a report on the risks of ESG and DEI executive compensation metrics. These results suggest that while the board's composition and executive compensation received stockholder backing, there was a lack of consensus on certain governance and policy-related initiatives proposed by shareholders.

May 4, 2026 8-K

Regulation FDOther EventsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Regulation FD Disclosure (Apr 28, 2026)

On April 28, 2026, Gilead Sciences completed its acquisition of Arcellx, Inc. (Nasdaq: ACLX) through a tender offer followed by a Section 251(h) merger. Shareholders receive $115.00 per share in cash plus one non-transferable contingent value right (CVR) worth up to $5.00 per share. Gilead describes the transaction as a total implied equity value of about $7.8 billion, and it used roughly $7.1 billion of cash to fund the Offer and Merger, including option, RSU and other payments. The tender offer expired April 27, 2026, with about 38.8 million shares tendered, which together with shares Gilead already owned represented approximately 77.2% of outstanding shares. This cleared the majority-of-shares threshold, and Arcellx is now a wholly owned subsidiary and will be delisted from Nasdaq. The strategic rationale centers on full control of anitocabtagene autoleucel (anito-cel), an investigational BCMA-directed CAR T-cell therapy for multiple myeloma that Kite had been collaborating on with Arcellx. Gilead says the deal eliminates future profit-share, milestone and royalty obligations, allowing it to consolidate development and decision-making and bring the program to patients. Management frames the next phase as execution on the regulatory and commercial launch, with anito-cel carrying Fast Track, Orphan Drug and RMAT designations from the FDA. For investors, the key financial effects are on earnings rather than near-term cash flow. Because the deal is accounted for as an asset acquisition, the acquired in-process R&D expense is expected to reduce Gilead's 2026 GAAP and non-GAAP diluted EPS by approximately $5.57 to $5.67. Excluding that charge, Gilead expects modest dilution in 2026 and 2027 and accretion from 2028 onward, contingent on FDA approval of anito-cel. The $5.00 CVR adds a further contingent liability tied to cumulative anito-cel sales exceeding $6.0 billion through December 31, 2029, with any payment due March 31, 2030.

Apr 28, 2026 8-K

Material AgreementsRegulation FDExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Material Agreement (Feb 23, 2026)

On February 22, 2026, Gilead Sciences agreed to acquire Arcellx (ACLX) through a two-step transaction: a tender offer for all shares Gilead does not already own at $115.00 per share in cash plus one non-transferable contingent value right (CVR) worth $5.00 per share, followed by a second-step merger on the same terms. The company describes the deal as implying an equity value of about $7.8 billion payable at closing, a 68% premium to Arcellx's 30-day VWAP as of February 20, 2026, and expected close in the second quarter of 2026. Gilead already owns roughly 11.5% of Arcellx, and tender and support agreements covering about 10.3% of outstanding shares (held by directors, executive officers, and affiliates of NEA and SR One) have been signed. The strategic rationale centers on anito-cel, Arcellx's BCMA-directed CAR T-cell therapy for relapsed or refractory multiple myeloma, co-developed with Kite under an existing collaboration. The FDA has accepted the anito-cel BLA for fourth-line use, with a PDUFA action date of December 23, 2026. Gilead says the acquisition gives it full control of the asset and eliminates the profit-share, milestone and royalty obligations under the collaboration, and that the deal is expected to be accretive to earnings per share in 2028 and beyond following FDA approval. Gilead also points to the D-Domain BCMA binder's potential use in in vivo cell therapy. The CVR pays an additional $5.00 per share if cumulative worldwide net sales of anito-cel exceed $6.0 billion on or before December 31, 2029. Investors should note the milestone is contingent on commercial success and regulatory approval, and that the merger agreement carries a $260 million termination fee payable by Arcellx in certain circumstances, including a superior offer. Completion depends on a majority tender threshold, HSR and foreign antitrust clearances, and other customary conditions.

Feb 23, 2026 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Feb 10, 2026)

Gilead Sciences closed out 2025 with a strong fourth quarter and full year, reporting Q4 total revenues up 5% to $7.9 billion and full-year revenues up 2% to $29.4 billion. Product sales excluding Veklury grew 4% to $28.0 billion for the year, led by HIV (up 6% to $20.8 billion, with Biktarvy up 7% to $14.3 billion and Descovy up 31%) and Liver Disease (up 6% to $3.2 billion). Veklury continued to decline (down 49% for the year) as COVID-19 hospitalizations fell, and Cell Therapy sales slipped 7% amid competitive pressure on Yescarta and Tecartus. GAAP diluted EPS rose sharply to $6.78 from $0.38, but that comparison is flattered by the prior year's large acquired IPR&D and impairment charges (including the CymaBay deal). Non-GAAP diluted EPS of $8.15 is the cleaner read on underlying earnings power, up 77% from $4.62. For 2026, Gilead guided to product sales of $29.6-30.0 billion (including about $600 million of Veklury), implying modest growth, and non-GAAP diluted EPS of $8.45-8.85. Q4 quality was mixed: non-GAAP EPS fell to $1.86 from $1.90 because of higher acquired IPR&D, and GAAP EPS benefited from a tax benefit and unrealized equity gains. Management also flagged a pipeline setback, as the Phase 3 ASCENT-07 Trodelvy trial missed its progression-free survival endpoint and the STAR-221 anti-TIGIT program was discontinued. Positive news included Phase 3 ARTISTRY-1 and ARTISTRY-2 results for the BIC/LEN single-tablet regimen and the strong launch of Yeztugo, the twice-yearly HIV PrEP therapy. The balance sheet remains solid, with $10.6 billion in cash and marketable securities, $3.3 billion of Q4 operating cash flow, and full-year free cash flow of $9.5 billion. Gilead paid $1.0 billion in Q4 dividends, and the Board declared a $0.82 quarterly dividend for Q1 2026. Investors should weigh the durable HIV franchise and new launches against Veklury erosion, cell therapy competition, and policy risks including Medicare Part D reform, ACA subsidy expiration, and the company's most-favored-nation pricing agreement with the U.S. government.

Feb 10, 2026 8-K

Leadership Changes

GILEAD SCIENCES, INC. 8-K Report, Executive Changes (Nov 19, 2025)

Gilead Sciences, Inc. (GILD) has filed an 8-K report disclosing a significant executive change. Effective December 5, 2025, Deborah H. Telman will step down from her role as Executive Vice President, Corporate Affairs and General Counsel. Her employment with the company is expected to conclude later in December. This transition marks the departure of a key member of Gilead's senior leadership. Investors should monitor any subsequent announcements regarding the replacement for Ms. Telman and the strategic implications of this change on corporate affairs and legal matters. The filing itself does not provide reasons for her departure or details about her future plans.

Nov 19, 2025 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Oct 30, 2025)

Gilead Sciences reported third quarter 2025 results on October 30, 2025, with total revenues up 3% to $7.8 billion and GAAP diluted EPS of $2.43, versus $1.00 a year earlier. The headline GAAP comparison is flattered by a $1.75 billion IPR&D impairment in Q3 2024 that did not recur, plus a roughly $400 million increase in royalty, contract and other revenue tied to a prior intellectual property sale that management does not expect to recur. Underlying product sales were flat-to-down at $7.3 billion (down 2%), but product sales excluding Veklury grew 4% to $7.1 billion, driven by HIV (Biktarvy up 6%, Descovy up 20%) and Livdelzi in Liver Disease, partially offset by Cell Therapy declines of 11%. Non-GAAP diluted EPS rose 22% to $2.47, a more representative measure of operating performance, which benefited from the one-time revenue and lower acquired IPR&D spending. Guidance was raised. Full-year 2025 product sales are now $28.4 to $28.7 billion (from $28.3 to $28.7 billion), and non-GAAP diluted EPS is $8.05 to $8.25 (from $7.95 to $8.25). GAAP diluted EPS guidance rose meaningfully to $6.65 to $6.85 from $5.85 to $6.15, largely reflecting a tax-related effect and a lower GAAP effective tax rate assumption of about 16%. Management's tone is constructive, citing a strong start for Yeztugo (lenacapavir PrEP), the Biktarvy patent settlements that push expected U.S. generic entry to April 2036 (more than two years later than the prior December 2033 projection), and Moody's outlook upgrade to positive. Key risks remain: Veklury sales collapsed 60% as COVID-19 hospitalizations declined, Cell Therapy faces ongoing competitive pressure, Trodelvy's 1L mTNBC data (ASCENT-03) is not yet an approved setting, and the company still carries about $9.4 billion in cash and securities against $24.8 billion of long-term liabilities. Operating cash flow was $4.1 billion in the quarter, with $1.0 billion in dividends and $435 million in share repurchases. The company also announced the Interius acquisition and a planned $32 billion U.S. investment through 2030.

Oct 30, 2025 8-K

Regulation FDExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Regulation FD Disclosure (Oct 6, 2025)

Gilead Sciences, Inc. (GILD) announced on October 6, 2025, that it has reached settlement agreements with Lupin Ltd., Cipla Ltd., and Laurus Labs Ltd. These agreements resolve patent litigations concerning generic versions of Biktarvy®. The key outcome for investors is that these settlements prevent generic entry of Biktarvy® in the United States until at least April 1, 2036. This extended patent protection for Biktarvy®, a significant product for Gilead, provides considerable revenue certainty for the coming years. While the filing includes standard forward-looking statements and disclaimers regarding potential risks and uncertainties, the primary takeaway is the extended market exclusivity for a key revenue driver, which should be viewed positively by investors.

Oct 6, 2025 8-K

Leadership Changes

GILEAD SCIENCES, INC. 8-K Report, Executive Changes (Aug 14, 2025)

Gilead Sciences, Inc. (GILD) announced a key leadership change in its financial reporting structure through an 8-K filing on August 13, 2025. The company has appointed Erin Burkhart as the new Senior Vice President, Controllership and principal accounting officer, effective September 22, 2025. This appointment brings a seasoned financial executive with extensive experience in the biotechnology and pharmaceutical sectors to a critical role within Gilead's finance organization. Ms. Burkhart's prior roles include Group Vice President and Chief Accounting Officer at BioMarin Pharmaceutical Inc., and various senior accounting and finance positions at Eli Lilly and Company. Her background in public accounting with major firms and her CPA certification underscore her qualifications for overseeing Gilead's financial reporting. This transition marks a change in leadership for the principal accounting officer role, with Diane E. Wilfong stepping down from her interim position.

Aug 14, 2025 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Aug 7, 2025)

Gilead Sciences reported second-quarter 2025 results on August 7, 2025, with total revenue up 2% to $7.1 billion and product sales excluding Veklury up 4% to $6.9 billion, led by HIV (up 7% to $5.1 billion, with Biktarvy up 9% and Descovy up 35%). Trodelvy grew 14% and Livdelzi contributed to growth, while Liver Disease (down 4%), Veklury (down 44%), and Cell Therapy (down 7%) were weaker. GAAP diluted EPS rose to $1.56 from $1.29, but this was flattered by $142 million of gains on equity securities; the $190 million IPR&D impairment (MYR acquisition assets) weighed on GAAP results. Non-GAAP diluted EPS was flat at $2.01. Operating cash flow was $827 million after a final $1.3 billion transition tax payment, and free cash flow was $720 million. Management raised full-year guidance: product sales now $28.3-28.7 billion (up from $28.2-28.6 billion), non-GAAP diluted EPS now $7.95-8.25 (up from $7.70-8.10), and GAAP diluted EPS now $5.85-6.15. Veklury guidance was cut to about $1.0 billion from $1.4 billion, so the raise reflects growth in the core portfolio. Key strategic developments include FDA approval of Yeztugo (lenacapavir) as the first twice-yearly HIV PrEP option, positive Phase 3 ASCENT-03 data for Trodelvy in first-line mTNBC, and an FDA clinical hold on the GS-1720 and GS-4182 HIV treatment trials. Capital allocation remained shareholder-friendly. Gilead paid $994 million in dividends and repurchased $527 million of stock in the quarter, declared a $0.79 quarterly dividend, and authorized a new $6.0 billion buyback. Cash and marketable securities fell to $7.1 billion from $10.0 billion at year-end 2024, reflecting the transition tax payment and capital returns. The filing also disclosed a final settlement with the U.S. Department of Justice on a legacy compliance matter, which had been accrued in 2024.

Aug 7, 2025 8-K

Corporate ChangesExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Bylaw Amendment (Aug 4, 2025)

Gilead Sciences, Inc. (GILD) has filed a Current Report on Form 8-K detailing significant amendments to its corporate bylaws, effective July 30, 2025. The primary changes focus on enhancing the procedural and disclosure requirements for stockholder nominations of directors and the submission of proposals at stockholder meetings. These amendments aim to increase transparency and clarity around shareholder actions, particularly concerning advance notice provisions. Investors should note the strengthened background information requirements for proposing stockholders and nominees, as well as explicit compliance mandates with SEC regulations like the universal proxy rules. Furthermore, the Amended and Restated Bylaws address the exclusive use of the company's white proxy card, update provisions related to meeting adjournments and stockholder lists to align with Delaware law, and clarify director election majority vote provisions and board vacancy filling. The changes also include provisions for emergency conditions and other administrative updates. While these amendments do not immediately impact financial performance, they are crucial for understanding corporate governance and the mechanics of shareholder engagement moving forward.

Aug 4, 2025 8-K

Shareholder MattersExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Shareholder Vote Results (May 8, 2025)

Gilead Sciences, Inc. (GILD) filed an 8-K on May 7, 2025, reporting the results of its 2025 annual meeting of stockholders held on May 6, 2025. The meeting saw strong participation, with over 1.12 billion shares represented, ensuring a quorum. Key outcomes include the election of all nine director nominees, who will serve for the upcoming year. Stockholders also overwhelmingly ratified the appointment of Ernst & Young LLP as the independent registered public accounting firm for fiscal year 2025. Furthermore, shareholders provided advisory approval for the compensation of the Company's Named Executive Officers. However, several stockholder proposals did not receive sufficient support. These included proposals requesting the CEO pay ratio factor be included in executive compensation programs, the adoption of an independent Board Chair policy, a comprehensive human rights policy, and a report on the risks of DEI practices for contractors. The overwhelming rejection of these proposals suggests shareholder alignment with the current board and management's approach to these governance and policy matters.

May 8, 2025 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Apr 24, 2025)

Gilead Sciences reported first quarter 2025 results on April 24, 2025, with total revenue flat year-over-year at $6.7 billion (total revenues $6,667M vs. $6,686M). The headline story is the quality of the underlying base business: product sales excluding Veklury grew 4% to $6.3 billion, led by HIV (+6% to $4.6 billion), with Biktarvy up 7% to $3.1 billion and Descovy up 38% to $586 million. Offsetting weakness came from Veklury (down 45% to $302 million as COVID hospitalizations declined) and Oncology (down 4%, with Trodelvy down 5%). GAAP diluted EPS was $1.04, versus a loss of $(3.34) a year earlier, but that comparison is distorted by the prior-year $3.9 billion CymaBay IPR&D charge and $2.4 billion Immunomedics impairment. Non-GAAP diluted EPS was $1.81, and operating cash flow was $1.8 billion, with free cash flow of $1.65 billion. Capital returns continued during the quarter, with $1.0 billion in dividends, $730 million in share repurchases, and $1.8 billion of senior notes repaid in February. Cash fell to $7.9 billion from $10.0 billion at year-end, reflecting those uses. Full-year 2025 guidance was largely maintained: product sales of $28.2–28.6 billion, and non-GAAP diluted EPS of $7.70–8.10. GAAP diluted EPS guidance was lowered to $5.65–6.05 from $5.95–6.35, driven by higher expected acquisition-related and restructuring charges, fair value adjustments, and tax items rather than a change to the operating outlook. Key catalysts flagged by management include the June 19, 2025 PDUFA date for twice-yearly lenacapavir for HIV prevention (priority review in the U.S., with EMA review also underway), positive Phase 3 ASCENT-04 data for Trodelvy plus Keytruda in first-line PD-L1+ triple-negative breast cancer, and a planned Phase 3 study of once-yearly lenacapavir in the second half of 2025. The quarterly dividend was declared at $0.79 per share, payable June 27, 2025.

Apr 24, 2025 8-K

Leadership Changes

GILEAD SCIENCES, INC. 8-K Report, Executive Changes (Mar 12, 2025)

Gilead Sciences, Inc. (GILD) announced a significant change in its senior accounting leadership via an 8-K filing on March 12, 2025. Sandra Patterson, the Senior Vice President, Corporate Controller and Chief Accounting Officer, and principal accounting officer, has departed from the company. This leadership transition necessitates a search for a permanent successor. In the interim, the Board of Directors has appointed Diane E. Wilfong to serve as the interim Corporate Controller and Chief Accounting Officer, and interim principal accounting officer. Ms. Wilfong brings a wealth of experience to this role, having previously held the position of Corporate Controller and Chief Accounting Officer at Gilead from 2016 to 2023, and prior experience at Computer Sciences Corporation, Caesars Entertainment, and Eastman Kodak. Her reappointment suggests a focus on stability and experienced oversight during this transition period.

Mar 12, 2025 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Feb 11, 2025)

Gilead Sciences (GILD) reported fourth quarter and full year 2024 results on February 11, 2025, showing strong commercial momentum in its base business alongside large non-cash charges that depressed GAAP earnings. Full-year 2024 total revenue rose 6% to $28.8 billion, with product sales excluding Veklury up 8% to $26.8 billion, led by HIV (Biktarvy sales up 13% to $13.4 billion). Fourth-quarter revenue grew 6% to $7.6 billion and GAAP diluted EPS rose to $1.42 from $1.14, while full-year GAAP diluted EPS fell sharply to $0.38 from $4.50 due to a $4.2 billion IPR&D impairment tied to Immunomedics assets and $3.9 billion of acquired IPR&D charges from the CymaBay acquisition. Non-GAAP full-year diluted EPS declined to $4.62 from $6.72, reflecting the CymaBay charge and higher taxes. Management's 2025 guidance projects product sales of $28.2 to $28.6 billion, with non-GAAP diluted EPS of $7.70 to $8.10, and the company is preparing for a potential summer 2025 launch of twice-yearly lenacapavir for HIV PrEP, for which regulatory submissions have been completed. Balance sheet and cash generation remained solid, with full-year operating cash flow of $10.8 billion, free cash flow of $10.3 billion, and cash and marketable securities of $10.0 billion at year end, though the company issued $3.5 billion in senior notes during the quarter and declared a $0.79 quarterly dividend for Q1 2025. Investors should weigh the strong underlying franchise and growth outlook against risks including Veklury's declining contribution, Biktarvy and HIV dependence, pricing and payer pressure, and the company's continued reliance on acquisitions and in-process R&D, which drive periodic GAAP earnings volatility.

Feb 11, 2025 8-K/A

Leadership ChangesExhibits & Filings

GILEAD SCIENCES, INC. 8-K/A Report, Executive Changes (Dec 13, 2024)

Gilead Sciences filed this Form 8-K on December 12, 2024 (reported as filed December 13) to disclose a leadership change in its executive suite. Chief Medical Officer Merdad Parsey, M.D., Ph.D., is leaving the company following a transition. Dietmar Berger, M.D., Ph.D., a former Chief Medical Officer and Global Head of Development at Sanofi, will succeed him as CMO effective January 2, 2025. Berger will oversee the company's global Development and Medical Affairs organizations and take responsibility for the virology, oncology and inflammation portfolio. Dr. Parsey will remain as a Senior Advisor through the first quarter of 2025, after which his employment will be terminated without cause. The filing discloses no financial results, guidance, or compensation terms for either executive. The press release notes Berger's track record of global regulatory filings, including multiple cancer treatments, and CEO Daniel O'Day frames the hire as supporting Gilead's virology leadership and its oncology and inflammation opportunities. For investors, this is a planned, orderly succession with a one-quarter overlap period, which tends to limit execution risk. The main watch items are whether the transition stays on schedule and whether the new CMO's development priorities shift the timing of key pipeline readouts. The forward-looking statements explicitly flag the risk that the transition may not close on current timelines.

Dec 13, 2024 8-K

Material AgreementsFinancial EventsOther Events+1

GILEAD SCIENCES, INC. 8-K Report, Material Agreement (Nov 20, 2024)

Gilead Sciences, Inc. (GILD) has filed an 8-K report detailing a significant financing transaction. On November 20, 2024, the company entered into a Tenth Supplemental Indenture to issue approximately $3.5 billion in aggregate principal amount of senior notes across four different series: 4.80% Senior Notes due 2029 ($750 million), 5.10% Senior Notes due 2035 ($1 billion), 5.50% Senior Notes due 2054 ($1 billion), and 5.60% Senior Notes due 2064 ($750 million). These notes were issued under the company's effective shelf registration statement and the proceeds are intended for general corporate purposes, which may include the repayment of existing indebtedness. The transaction represents a strategic move to bolster Gilead's liquidity and potentially optimize its capital structure. Investors should note the various interest rates and maturity dates associated with these new debt obligations, as well as the covenants and redemption provisions outlined in the supplemental indenture.

Nov 20, 2024 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Nov 6, 2024)

Gilead Sciences reported third quarter 2024 results on November 6, 2024, with total revenue up 7% year-over-year to $7.5 billion and product sales excluding Veklury up 7% to $6.8 billion. Growth was led by HIV, where Biktarvy sales rose 13% to $3.5 billion, and by Oncology (up 6%) and Liver Disease (up 4%). Management raised full-year 2024 guidance for product sales ($27.8–$28.1 billion, up from $27.1–$27.5 billion), non-GAAP diluted EPS ($4.25–$4.45, up from $3.60–$3.90), and Veklury sales ($1.8 billion, up from $1.3 billion). GAAP diluted EPS was $1.00, down from $1.73, primarily due to a $1.75 billion non-cash IPR&D impairment tied to assets acquired from Immunomedics in 2020, along with $505 million of acquired IPR&D expense that included a $320 million charge to buy out Livdelzi royalties. Beneath the headline numbers, profitability and balance sheet metrics warrant attention. Non-GAAP diluted EPS declined 12% year-over-year to $2.02 because of higher acquired IPR&D and tax expense. Cash, cash equivalents and marketable debt securities fell to $5.0 billion from $8.4 billion at year-end 2023, largely reflecting the $3.9 billion CymaBay acquisition, and intangible assets declined to $20.5 billion from $26.5 billion, partly from the impairment. Free cash flow was strong at $4.2 billion in the quarter, and the company paid $983 million in dividends and repurchased $300 million of stock. On the pipeline side, Gilead reported PURPOSE 2 Phase 3 data for twice-yearly lenacapavir HIV prevention, with 99.9% of participants uninfected, and said it expects to file with the FDA before year-end. The company also received FDA accelerated approval for Livdelzi in primary biliary cholangitis, and announced plans to voluntarily withdraw the U.S. accelerated approval of Trodelvy in urothelial cancer following the TROPiCS-04 trial. The quarterly dividend was declared at $0.77 per share.

Nov 6, 2024 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Aug 8, 2024)

Gilead Sciences reported second-quarter 2024 results with total revenue up 5% year-over-year to $6.95 billion and product sales of $6.91 billion. Excluding Veklury (COVID-19 treatment, down 16%), product sales grew 6% to $6.7 billion, led by HIV (Biktarvy up 8% to $3.2 billion), Liver Disease (up 17%), and Oncology (up 15%, with Trodelvy up 23%). GAAP diluted EPS rose to $1.29 from $0.83, largely because the prior-year quarter included a $525 million HIV antitrust settlement expense that did not recur. Non-GAAP diluted EPS was $2.01 versus $1.34. Gross margin on a GAAP basis slipped modestly to 77.7%, and operating expenses declined sharply, with SG&A down to $1.4 billion from $1.8 billion. The quarter also carried notable balance-sheet and pipeline developments. Cash and marketable securities fell to $2.8 billion from $8.4 billion at year-end 2023, reflecting the $3.9 billion CymaBay acquisition and a $1.75 billion senior note repayment. Operating cash flow of $1.3 billion was held down by a $1.2 billion transition tax payment. The company paid $972 million in dividends and repurchased $100 million of stock. Management reaffirmed product sales guidance of $27.1–27.5 billion and raised GAAP diluted EPS guidance to $0.00–0.30 (from $0.10–0.50), while raising non-GAAP EPS guidance to $3.60–3.90. The GAAP guidance is weighed down by a large first-half IPR&D impairment of $2.43 billion, which was recorded in Q1 2024. For investors, the key items to watch are the seladelpar PDUFA date of August 14, 2024, interim lenacapavir PrEP data from PURPOSE 1 showing 100% efficacy in cisgender women, and the setback in the TROPiCS-04 urothelial cancer Phase 3 trial, which missed its overall survival endpoint. The Q2 press release also notes a $320 million buyout of seladelpar royalties from Janssen, which will be reflected in Q3 results.

Aug 8, 2024 8-K

Leadership ChangesExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Executive Changes (Jul 17, 2024)

Gilead Sciences (GILD) disclosed in an 8-K filed July 17, 2024 that Chief Medical Officer Merdad Parsey, MD, PhD, will leave the company in early 2025. Dr. Parsey will remain in the CMO role while Gilead identifies a successor, and his transition of duties is expected to run through the first quarter of 2025 or another mutually agreed date. No formal departure date has been set, and the filing reports no change to his compensation or other terms. The filing is a leadership-transition event rather than a financial or clinical event, so it does not directly affect reported results, guidance, or the pipeline. Investors should weigh it against the company's oversight of global clinical development and medical affairs, which Dr. Parsey led since joining in November 2019. Chairman and CEO Daniel O'Day credited him with more than doubling the portfolio and cited 54 ongoing clinical trials across virology, oncology, and inflammation. The main near-term question is execution risk: how quickly Gilead names a successor and whether the development pipeline keeps its momentum through the handoff. The press release's forward-looking statements flag both the possibility of an earlier-than-planned departure and the difficulty of finding a replacement. Investors should watch for a named successor and any update in upcoming quarterly reports.

Jul 17, 2024 8-K

Shareholder MattersCorporate ChangesExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Bylaw Amendment (May 9, 2024)

Gilead Sciences, Inc. (GILD) filed an 8-K on May 9, 2024, detailing the outcomes of its 2024 Annual Meeting of Stockholders held on May 8, 2024. The primary focus of the filing is the approval of amendments to the company's Restated Certificate of Incorporation, specifically to align with new Delaware laws on officer exculpation. This change, adopted by the Board in February and approved by stockholders, aims to further protect officers from personal liability for certain breaches of fiduciary duty, a common corporate governance update in Delaware. Beyond governance, the meeting saw the election of nine directors to the Board, all of whom received strong support from shareholders. Key proposals included the ratification of Ernst & Young LLP as the independent registered public accounting firm for fiscal year 2024, and an advisory vote on executive compensation, both of which were approved. Importantly, several stockholder proposals, including those related to employee board representation, reporting on risks associated with state policies on abortion, and enhanced executive stock retention, were not approved by the majority of shareholders.

May 9, 2024 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Apr 25, 2024)

Gilead Sciences reported first quarter 2024 results on April 25, 2024, showing underlying commercial strength but a sharply lower GAAP profit picture driven by a one-time acquisition charge. Total revenue rose 5% to $6.7 billion, and product sales excluding Veklury grew 6% to $6.1 billion, led by Biktarvy (up 10% to $2.9 billion), Oncology (up 18% to $789 million, with Trodelvy up 39%), and Liver Disease (up 9% to $737 million). Growth in the base business was offset by a $4.1 billion acquired IPR&D charge, primarily the $3.9 billion charge from the CymaBay Therapeutics acquisition, plus a $2.4 billion IPR&D impairment tied to older Immunomedics assets. As a result, GAAP diluted EPS was $(3.34) versus $0.80 a year earlier, while non-GAAP diluted EPS was $(1.32) versus $1.37. The company materially cut its full-year 2024 GAAP diluted EPS guidance to $0.10–$0.50 from $5.15–$5.55, and non-GAAP diluted EPS guidance to $3.45–$3.85 from $6.85–$7.25. Management left product sales guidance unchanged at $27.1–$27.5 billion, so the revision reflects the non-cash and acquisition-related charges rather than a deterioration in expected sales. Cash fell to $4.7 billion from $8.4 billion at year-end 2023 following the CymaBay deal, though operating cash flow of $2.2 billion and a $0.77 quarterly dividend were maintained. The key near-term catalyst highlighted is the FDA decision on seladelpar for primary biliary cholangitis, with a PDUFA date of August 14, 2024.

Apr 25, 2024 8-K

Regulation FDOther EventsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Regulation FD Disclosure (Mar 22, 2024)

On March 22, 2024, Gilead Sciences completed its acquisition of CymaBay Therapeutics, a transaction valued at approximately $4.3 billion in total equity value. Gilead's Purchaser subsidiary tender offer, which expired March 21, 2024 at $32.50 per share in cash, received about 93.7 million shares (roughly 77.3% of outstanding shares), with an additional 5.1 million shares (about 4.2%) tendered via Notices of Guaranteed Delivery. The tender condition was satisfied, and the remaining merger was completed under DGCL Section 251(h) with CymaBay becoming a wholly owned subsidiary, and its Nasdaq listing expected to end at market close on March 22, 2024. Strategically, the deal adds CymaBay's lead investigational candidate, seladelpar, for primary biliary cholangitis (PBC) including pruritus, extending Gilead's liver disease franchise, which it describes as built on more than 20 years of work in the area. Seladelpar has not been approved anywhere globally, and its safety and efficacy have not been established, so its commercial value remains contingent on clinical and regulatory outcomes. For investors, the key financial impact is earnings dilution in 2024. The transaction is expected to be accounted for as an asset acquisition, reducing Gilead's GAAP and non-GAAP 2024 EPS by about $3.10 to $3.20, or about $3.35 to $3.45 after including acquisition costs, associated operating expenses, and lower interest income, relative to the February 6, 2024 full-year guidance.

Mar 22, 2024 8-K

Leadership Changes

GILEAD SCIENCES, INC. 8-K Report, Executive Changes (Mar 14, 2024)

Gilead Sciences, Inc. (GILD) filed an 8-K report on March 14, 2024, to announce the upcoming retirement of a key board member. Kevin E. Lofton, a member of the Board of Directors, has notified the company of his decision to retire, which will be effective at the conclusion of his term at the company's next annual meeting of stockholders on May 8, 2024. This transition appears to be planned and voluntary, as the filing explicitly states that Mr. Lofton's decision was not due to any disagreements with the Board or management.

Mar 14, 2024 8-K

Material AgreementsOther EventsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Material Agreement (Feb 12, 2024)

On February 11, 2024, Gilead Sciences (GILD) entered into a definitive Merger Agreement to acquire CymaBay Therapeutics (CBAY) for $32.50 per share in cash, implying a total equity value of about $4.3 billion and a 27% premium to CymaBay's February 9, 2024 closing price. The deal is structured as a two-step transaction: a Gilead subsidiary (Pacific Merger Sub, Inc.) will launch a tender offer, followed by a second-step merger under DGCL Section 251(h) at the same price for any shares not tendered. Completion requires a majority tender, expiration or termination of the HSR waiting period, and no prohibiting law or order. The companies expect closing in the first quarter of 2024. The strategic rationale centers on seladelpar, CymaBay's lead investigational oral PPARδ agonist for primary biliary cholangitis (PBC), including pruritus. The FDA has accepted the New Drug Application with priority review and a PDUFA target date of August 14, 2024, and seladelpar holds Breakthrough Therapy, PRIME, and Orphan designations. Phase 3 RESPONSE trial data showed biochemical response of 61.7% versus 20.0% for placebo. Gilead expects the deal to be approximately neutral to EPS in 2025 and significantly accretive thereafter, and it expects the acquisition to enhance revenue growth once seladelpar is approved. For investors, the key items are the modest size of the deal relative to Gilead's scale, the single-asset pipeline risk concentrated in seladelpar, and the deal protections: a no-shop clause with a fiduciary out for superior proposals, and a $151.6 million termination fee payable by CymaBay in certain circumstances. The filing also includes extensive cautionary language, and the representations and warranties are qualified by confidential disclosure schedules, so the filing alone does not establish the factual condition of either company.

Feb 12, 2024 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Feb 6, 2024)

Gilead Sciences closed 2023 with total revenue of $27.1 billion, down 1% year over year, as a $1.7 billion decline in Veklury (remdesivir) sales was largely offset by growth in HIV and Oncology. Excluding Veklury, product sales rose 7% to $24.7 billion. Biktarvy grew 14% to $11.8 billion, Trodelvy rose 56% to $1.1 billion, and Cell Therapy (Yescarta and Tecartus) grew 28% to $1.9 billion. The base business is clearly strengthening, while the headline top line is held back by the COVID-19 franchise's normalization. Profitability was mixed. GAAP diluted EPS rose to $4.50 from $3.64, helped by lower IPR&D impairments and lower equity investment losses. Non-GAAP diluted EPS fell to $6.72 from $7.26, reflecting higher R&D and SG&A, including a $525 million HIV antitrust litigation settlement, and lower Veklury sales. Fourth-quarter GAAP product gross margin fell sharply to 70.4% from 81.0%, driven by restructuring charges tied to a manufacturing strategy change. Cash generation remained solid, with full-year operating cash flow of $8.0 billion and free cash flow of $7.4 billion, against $8.4 billion of cash and marketable securities. For 2024, management guided total product sales of $27.1 to $27.5 billion, non-GAAP diluted EPS of $6.85 to $7.25, and GAAP diluted EPS of $5.15 to $5.55. Veklury is expected to contribute only about $1.3 billion. Management highlighted several 2024 catalysts, including long-acting HIV prevention and treatment updates, Cell Therapy milestones, and Trodelvy readouts. Setbacks included the failed Phase 3 OAKTREE obeldesivir trial and the EVOKE-01 Trodelvy lung cancer trial. The quarterly dividend was set at $0.77 per share.

Feb 6, 2024 8-K

Leadership ChangesExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Executive Changes (Feb 2, 2024)

Gilead Sciences filed an 8-K on February 2, 2024 reporting a board appointment rather than a financial or operational event. On February 1, 2024, the Board expanded from nine to ten directors and elected Ted W. Love, M.D., effective immediately. Dr. Love was also selected for the Audit Committee, effective after the 2024 Annual Meeting of Stockholders and subject to his re-election by shareholders at that meeting. The filing discloses no arrangement or related-party transaction tied to his selection. For investors, the filing carries limited direct financial impact. It contains no earnings, guidance, pipeline data, or capital allocation changes. Its relevance lies in governance: Dr. Love brings extensive biopharma leadership experience, including former CEO of Global Blood Therapeutics, and a background in sickle cell disease and access-to-care advocacy. Adding an Audit Committee member with this profile is a modest governance positive, and the expanded board size is a structural change to note. Dr. Love's compensation will follow Gilead's standard non-employee director program for the remainder of the 2023-2024 service period, including grants under the 2022 Equity Incentive Plan. The filing refers to the 2023 proxy statement for program details. Investors should monitor the 2024 Annual Meeting, where shareholders vote on his re-election, along with the proxy disclosures that will describe his compensation.

Feb 2, 2024 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Nov 7, 2023)

Gilead Sciences reported third quarter 2023 results on November 7, 2023. Total revenue was $7.1 billion, flat year-over-year, as growth in Oncology and HIV was offset by lower Veklury (COVID-19 treatment) and hepatitis C sales. Product sales excluding Veklury rose 5% to $6.4 billion, and management described this as two years of consistent growth in the base business. GAAP diluted EPS rose to $1.73 from $1.42, and non-GAAP diluted EPS rose to $2.29 from $1.90. Both increases were driven mainly by a much lower effective tax rate (6.3% GAAP versus 26.6% a year earlier), which reflects a tax reserve release, not operating improvement. GAAP operating income actually declined slightly to $2.6 billion from $2.8 billion, and R&D and SG&A expenses rose sharply. The quarter's key operating drivers were Biktarvy (up 12% to $3.1 billion) and Oncology (up 33% to $769 million, led by Trodelvy up 58% and Yescarta up 23%). Margins were under pressure: GAAP product gross margin fell to 77.6% from 80.0%, largely due to intangible amortization from the Trodelvy approval. R&D rose 27% on GAAP basis, reflecting increased clinical activity and costs from discontinuing two magrolimab Phase 3 studies, and the FDA placed a partial clinical hold on magrolimab AML studies. The company also discontinued the Phase 3 BIRCH obeldesivir trial due to lower-than-expected COVID-19 incidence, though the OAKTREE trial continues. Guidance was mixed. Full-year total product sales were raised to $26.7-26.9 billion, and non-GAAP EPS was narrowed to $6.65-6.85 from $6.45-6.80, while GAAP EPS was narrowed to $4.55-4.75 and GAAP operating income guidance was lowered to $8.1-8.4 billion. Gilead ended the quarter with $8.0 billion in cash and marketable securities, generated $1.8 billion in operating cash flow, issued $2.0 billion of senior notes while repaying $2.3 billion of debt, and paid a $0.75 quarterly dividend.

Nov 7, 2023 8-K

Material AgreementsFinancial EventsOther Events+1

GILEAD SCIENCES, INC. 8-K Report, Material Agreement (Sep 14, 2023)

Gilead Sciences, Inc. (GILD) has filed an 8-K report detailing the entry into a material definitive agreement concerning the issuance of new senior notes. Specifically, on September 14, 2023, the company, along with Computershare Trust Company, National Association as trustee, executed a Ninth Supplemental Indenture. This indenture allows for the issuance of $1 billion in 5.250% Senior Notes due 2033 and $1 billion in 5.550% Senior Notes due 2053, totaling $2 billion in aggregate principal amount. These notes were sold through a public offering under an existing registration statement. The proceeds from this offering are intended for general corporate purposes. The filing also includes details on the underwriting agreement with Barclays Capital Inc. and Citibank Global Markets Inc., acting as representatives for the underwriters. The supplemental indenture outlines various covenants and restrictions, including limitations on secured indebtedness, sale and leaseback transactions, and provisions for debt repurchases upon a change of control. The company retains the option to redeem these notes under specified conditions.

Sep 14, 2023 8-K

Regulation FDExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Regulation FD Disclosure (Aug 16, 2023)

On August 16, 2023, Gilead Sciences (GILD) filed an 8-K under Regulation FD disclosing that the International Association for the Study of Lung Cancer (IASLC) inadvertently posted a draft presentation on its 2023 World Conference on Lung Cancer website ahead of Gilead's planned disclosure. Gilead states the posting was not authorized by the company. The filing attaches the draft presentation as Exhibit 99.1, covering preliminary results from the Phase 2 EVOKE-02 study of sacituzumab govitecan (SG, Trodelvy) plus pembrolizumab (Keytruda, Merck collaboration) in first-line metastatic non-small cell lung cancer (1L mNSCLC). The filing itself is primarily administrative; the investment-relevant content is in the exhibit's data. The preliminary data, with a June 16, 2023 data cutoff and investigator assessment, show an objective response rate (ORR) of 69% in the PD-L1 TPS ≥50% cohort (n=29 evaluable) and 44% in the PD-L1 TPS <50% cohort (n=32), or 56% overall. Disease control rates were 86%, 78%, and 82% respectively. Median duration of response was not reached in either cohort, with a 6-month DOR rate of 88% in both. Follow-up was short (median ~5-6 months), and the cohorts are small, so the results are preliminary and not directly comparable to randomized trial outcomes. Safety was consistent with each agent's known profile: all 63 treated patients had at least one treatment-emergent adverse event (TEAE), 70% had grade ≥3 TEAEs, and 18% discontinued study treatment due to TEAEs. One treatment-related death from sepsis was reported. Gilead notes that the randomized Phase 3 EVOKE-03 study (SG + pembrolizumab vs. pembrolizumab monotherapy in PD-L1 ≥50% 1L mNSCLC) is ongoing, which is the key catalyst for assessing the regimen's commercial potential.

Aug 16, 2023 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Aug 3, 2023)

Gilead Sciences reported second quarter 2023 results on August 3, 2023, with a mixed picture: the core business grew strongly, but GAAP earnings were hit by a one-time legal charge and management cut full-year GAAP guidance. Total revenue rose 5% year over year to $6.6 billion, and product sales excluding Veklury (the COVID-19 antiviral) grew 11% to $6.3 billion. HIV sales rose 9% to $4.6 billion, led by Biktarvy (up 17%), Oncology sales jumped 38% to $728 million, and Cell Therapy grew 27%. Veklury fell 43% to $256 million as COVID-19 hospitalizations declined. Profitability was pressured by a $525 million litigation accrual tied to settlements in the HIV antitrust litigation, which reduced GAAP diluted EPS by $0.32. GAAP diluted EPS fell to $0.83 from $0.91, and non-GAAP diluted EPS fell to $1.34 from $1.58. Higher R&D (up to $1.4 billion), higher SG&A (up to $1.8 billion), and a higher GAAP effective tax rate of 34.6% also weighed on results. Cash generation remained solid, with $2.3 billion of operating cash flow, $2.2 billion of free cash flow, and $8.0 billion in cash and marketable securities, while the company paid $944 million in dividends and repurchased $150 million of stock. For 2023, Gilead raised its product sales guidance to $26.3–26.7 billion, driven by the non-Veklury base business, but lowered its Veklury outlook to about $1.7 billion from $2.0 billion. It also cut GAAP diluted EPS guidance to $4.50–$4.85 from $4.75–$5.15 and non-GAAP diluted EPS guidance to $6.45–$6.80 from $6.60–$7.00. The quarterly dividend was declared at $0.75 per share.

Aug 3, 2023 8-K

Leadership ChangesShareholder MattersExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Executive Changes (May 5, 2023)

Gilead Sciences, Inc. (GILD) filed an 8-K on May 4, 2023, reporting on the outcomes of its Annual Meeting of Stockholders held on May 3, 2023. The primary focus for investors is the overwhelming approval of amendments to the Gilead Sciences, Inc. Employee Stock Purchase Plan and the Gilead Sciences, Inc. International Employee Stock Purchase Plan. This indicates strong stockholder support for employee equity participation and potentially the company's strategy to retain and incentivize its workforce through stock ownership. Additionally, the filing confirms the election of nine directors and the ratification of Ernst & Young LLP as the independent auditor for the fiscal year ending December 31, 2023. The meeting also included advisory votes on executive compensation, with stockholders approving the compensation of Named Executive Officers and supporting annual advisory votes on executive compensation going forward. Notably, several stockholder proposals, including those related to director nominations, special meeting rights for different share classes, and the impact of patent exclusivities on product access, did not receive majority support from stockholders. This suggests that management's recommendations on these matters were largely followed.

May 5, 2023 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Apr 27, 2023)

Gilead Sciences reported first-quarter 2023 results with total revenues down 4% year-over-year to $6.4 billion, as a 63% decline in Veklury (COVID-19 treatment) sales offset growth elsewhere. Excluding Veklury, product sales rose 15% to $5.7 billion, driven by HIV (up 13% to $4.2 billion, with Biktarvy up 24%), Cell Therapy (up 64% to $448 million), Trodelvy (up 52% to $222 million) and Liver Disease (up 6%). GAAP diluted EPS was $0.80 versus $0.02 a year earlier, but that comparison is distorted by a $2.7 billion IPR&D impairment booked in Q1 2022. Non-GAAP diluted EPS fell 35% to $1.37, reflecting higher R&D, higher acquired IPR&D expense ($481 million, tied to the Tmunity acquisition and the Arcellx and Nurix collaborations) and SG&A growth, alongside lower revenue. Guidance was mixed. Full-year total product sales ($26.0-26.5 billion), product sales excluding Veklury ($24.0-24.5 billion), Veklury (about $2.0 billion) and non-GAAP EPS ($6.60-7.00) were all reaffirmed. GAAP diluted EPS guidance was cut to $4.75-5.15 from $5.30-5.70, driven by about $600 million higher expected acquisition-related charges, which are excluded from non-GAAP results. Cash fell to $7.2 billion from $7.6 billion, with $1.7 billion of operating cash flow, $969 million of dividends and $400 million of buybacks in the quarter. The quarterly dividend was declared at $0.75 per share. The quarter shows Gilead's core franchises growing strongly while Veklury's pandemic tailwind fades. Investors will focus on whether HIV and Oncology growth can carry the business through the Veklury decline, and on the non-GAAP margin pressure from acquired IPR&D and operating spending.

Apr 27, 2023 8-K

Corporate ChangesExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Bylaw Amendment (Feb 6, 2023)

Gilead Sciences, Inc. (GILD) has filed an 8-K report on February 6, 2023, announcing an amendment to its corporate bylaws. The primary change involves a reduction in the ownership threshold required for stockholders to call a special meeting. This threshold has been lowered from 20% to 15% of the company's outstanding common stock. This amendment is significant for investors as it potentially empowers a broader group of shareholders to initiate special meetings, thereby increasing engagement and the possibility of addressing shareholder concerns or proposals more directly. While the company has not disclosed specific reasons for this change, it could signal a move towards greater shareholder responsiveness or be a proactive measure in anticipation of potential future shareholder activism.

Feb 6, 2023 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Feb 2, 2023)

Gilead Sciences reported fourth quarter and full year 2022 results on February 2, 2023. Full-year 2022 total revenue was $27.3 billion, flat versus 2021, as growth in HIV (Biktarvy up 20% to $10.4 billion), Cell Therapy (up 68%) and Trodelvy (up 79%) offset a 30% decline in Veklury (COVID-19 treatment) sales to $3.9 billion. Product sales excluding Veklury rose 8% to $23.1 billion, which management highlighted as the strongest base-business growth since HCV sales peaked in 2015. Fourth quarter revenue rose 2% to $7.4 billion. GAAP profitability was weighed down by a $2.7 billion IPR&D impairment in Q1 2022 tied to assets acquired from Immunomedics, and by a $406 million charge for terminating the Trodelvy collaboration with Everest in Asia. Diluted GAAP EPS fell to $3.64 from $4.93, while non-GAAP diluted EPS rose 1% to $7.26. Comparisons are also distorted by the non-recurring 2021 legal settlement charge and Arcus opt-in charge. Gilead ended 2022 with $7.6 billion in cash and marketable securities and generated $8.3 billion of free cash flow, which funded $5.8 billion in dividends and buybacks during the year (dividends alone were $916 million in Q4). For 2023, Gilead guided to total product sales of $26.0–26.5 billion (including about $2.0 billion of highly variable Veklury), GAAP EPS of $5.30–5.70, and non-GAAP EPS of $6.60–7.00. The guidance implies a modest revenue decline, driven by lower expected Veklury sales, with ex-Veklury product sales guided to $24.0–24.5 billion. Investors will want to track Biktarvy's share gains against the Veklury decline and how the new acquisitions and collaborations (Arcellx, Tmunity, GS-1811, EVOQ) affect R&D and acquired IPR&D spending.

Feb 2, 2023 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Oct 27, 2022)

Gilead Sciences reported third-quarter 2022 results that were mixed on the top and bottom lines but showed strong underlying growth in its core franchises. Total revenue fell 5% year-over-year to $7.0 billion, driven by a 52% decline in Veklury (remdesivir) sales to $925 million as COVID-19 hospitalizations fell. Excluding Veklury, product sales rose 11% to $6.1 billion, led by Biktarvy (up 22% to $2.8 billion), cell therapy (up 79% to $398 million), and Trodelvy (up 78% to $180 million). GAAP diluted EPS fell to $1.42 from $2.05, primarily due to a $389 million acquired IPR&D charge tied to the MiroBio acquisition, which was also non-deductible for tax purposes. Non-GAAP diluted EPS declined to $1.90 from $2.65. Management raised full-year 2022 guidance, now expecting total product sales of $25.9-26.2 billion (up from $24.5-25.0 billion), driven largely by an increase in Veklury sales to about $3.4 billion from $2.5 billion. GAAP EPS guidance was raised to $3.35-3.55 and non-GAAP EPS to $6.95-7.15. The guidance increase is notable because it is largely attributable to Veklury, a product whose demand is tied to COVID-19 trends, so the raised outlook depends on pandemic-driven sales holding up in the fourth quarter. Balance sheet and cash flow were solid. Operating cash flow was $2.9 billion in the quarter, free cash flow was $2.7 billion, and the company repaid $1.0 billion of debt and paid $928 million in dividends. Cash and marketable securities declined to $6.9 billion from $7.8 billion at year-end 2021. The board declared a quarterly dividend of $0.73 per share for Q4 2022. Investors should note the large nine-month GAAP IPR&D impairment of $2.7 billion, which weighed heavily on year-to-date GAAP results, and the continued amortization of intangible assets, which reduced intangible assets to $29.4 billion.

Oct 27, 2022 8-K

Regulation FD

GILEAD SCIENCES, INC. 8-K Report, Regulation FD Disclosure (Sep 12, 2022)

Gilead Sciences, Inc. (GILD) announced on September 12, 2022, that it has reached agreements with several generic manufacturers to resolve patent litigation concerning its key HIV and Hepatitis B medications: Descovy®, Vemlidy®, and Odefsey®. These agreements grant non-exclusive licenses in the United States for the underlying patents related to tenofovir alafenamide. This resolution is significant for investors as it clarifies the future market entry of generic versions of these important drugs. The licenses begin on October 31, 2031, for Descovy and Vemlidy, and January 31, 2032, for Odefsey, with potential earlier termination under specific conditions. This provides Gilead with a defined period of market exclusivity for these products in the US, mitigating immediate patent challenges and offering a degree of predictability for future revenue streams.

Sep 12, 2022 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Aug 2, 2022)

Gilead Sciences reported second quarter 2022 results on August 2, 2022, with total revenue up 1% year-over-year to $6.3 billion ($6,260 million). Growth was driven by HIV (Biktarvy sales up 28% to $2.6 billion) and oncology (cell therapy up 68% to $368 million, Trodelvy up 79% to $159 million), which offset steep declines in Veklury (down 46% to $445 million) and HCV (down 18%). Excluding Veklury, product sales grew 7%. Profitability weakened: GAAP diluted EPS fell to $0.91 from $1.21, driven by a $300 million upfront payment to Dragonfly Therapeutics (about $0.18 per share), higher net unrealized losses on equity investments, and a new Biktarvy-related royalty expense that began in Q1 2022 and compresses product gross margin. Non-GAAP diluted EPS declined 13% to $1.58. The six-month GAAP picture is far weaker because of a $2.7 billion IPR&D impairment recorded in the first quarter of 2022, which drove six-month GAAP diluted EPS to $0.92 versus $2.58 a year earlier. Liquidity remains solid: operating cash flow was $1.8 billion in the quarter, free cash flow was $1.66 billion, and cash and marketable securities were $7.0 billion, down from $7.8 billion at year-end 2021, after dividends of $920 million, debt repayments, and the bictegravir litigation settlement. Gilead raised full-year product sales guidance to $24.5-25.0 billion and non-GAAP EPS guidance to $6.35-6.75, while lowering GAAP EPS guidance to $2.90-3.30. Investors should weigh the strong underlying commercial momentum in HIV and oncology against the Veklury decline, rising royalty and acquisition-related costs, and the large gap between GAAP and non-GAAP earnings.

Aug 2, 2022 8-K

Leadership Changes

GILEAD SCIENCES, INC. 8-K Report, Executive Changes (Jul 28, 2022)

Gilead Sciences, Inc. (GILD) announced a planned leadership transition in its finance department. Diane Wilfong, Senior Vice President, Corporate Controller, and Chief Accounting Officer, will step down from her principal accounting officer role on March 1, 2023. Ms. Wilfong will remain with the company to ensure a smooth transition and support strategic initiatives. Sandra Patterson, currently Vice President, Assistant Controller, is appointed to succeed Ms. Wilfong as Senior Vice President, Corporate Controller, and principal accounting officer, also effective March 1, 2023. Ms. Patterson brings extensive experience within Gilead and from prior roles at prominent companies, along with relevant professional qualifications. This transition is a routine management change aimed at ensuring continuity and leveraging existing talent within the organization.

Jul 28, 2022 8-K

Leadership Changes

GILEAD SCIENCES, INC. 8-K Report, Executive Changes (May 31, 2022)

Gilead Sciences, Inc. (GILD) filed an 8-K on May 31, 2022, primarily to disclose information regarding a compensatory arrangement for Brett A. Pletcher, Executive Vice President, Corporate Affairs and General Counsel. Mr. Pletcher is retiring from his full-time role but will transition to a part-time capacity. This arrangement is designed to ensure a smooth handover of his responsibilities and to leverage his expertise in ongoing litigation matters. Investors should note that this move is focused on executive transition and continued support rather than significant operational or financial changes.

May 31, 2022 8-K

Shareholder MattersExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Shareholder Vote Results (May 5, 2022)

This 8-K filing from Gilead Sciences, Inc. (GILD) reports the results of its 2022 Annual Meeting of Stockholders held on May 4, 2022. The meeting was conducted virtually, with a substantial majority of shares represented, indicating strong shareholder engagement. Key outcomes include the election of nine directors to the board, the ratification of Ernst & Young LLP as the independent auditor for fiscal year 2022, and the approval of the 2022 Equity Incentive Plan. Additionally, advisory approval was granted for the compensation of the company's named executive officers. Shareholders also voted on several proposals, with mixed results on various stockholder-initiated measures regarding board independence, employee representation, special meeting thresholds, lobbying activities, and anticompetitive practice oversight.

May 5, 2022 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Apr 28, 2022)

Gilead Sciences reported first quarter 2022 results on April 28, 2022, with total revenue up 3% to $6.6 billion and product sales up 3% to $6.5 billion. The headline GAAP result was weak: diluted EPS fell to $0.02 from $1.37 a year earlier, driven by a $2.7 billion in-process R&D impairment tied to assets acquired from Immunomedics in 2020. Excluding that charge and other adjustments, non-GAAP diluted EPS rose 4% to $2.12, supported by higher product sales. Underlying growth came from Biktarvy (up 18% to $2.2 billion), oncology (up 60% to $420 million, led by Trodelvy and cell therapy), and Veklury, partly offset by Truvada's loss of exclusivity and HCV pricing pressure. The company cut its full-year 2022 GAAP EPS guidance to $3.00–$3.50 from $4.70–$5.20, reflecting the impairment. It left non-GAAP EPS guidance unchanged at $6.20–$6.70 and kept product sales guidance of $23.8–$24.3 billion (about $21.8–$22.3 billion excluding Veklury). Cash, equivalents and marketable securities fell to $6.8 billion from $7.8 billion, reflecting a $1.25 billion legal settlement, a $725 million Arcus collaboration payment, $500 million of debt repayment, $945 million of dividends and $352 million of buybacks. The quarter also included regulatory and clinical updates. Gilead received an FDA Complete Response Letter for lenacapavir in heavily treatment-experienced HIV patients, related to vial compatibility, and Trodelvy met its Phase 3 TROPiCS-02 primary endpoint in HR+/HER2- metastatic breast cancer. Yescarta received FDA approval for a second-line LBCL indication. The Board declared a $0.73 quarterly dividend. Investors should weigh the largely non-cash impairment against stable underlying franchise performance and the reduced GAAP outlook.

Apr 28, 2022 8-K

Regulation FDExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Regulation FD Disclosure (Mar 7, 2022)

On March 7, 2022, Gilead Sciences announced topline results from the Phase 3 TROPiCS-02 study of Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who had received prior endocrine therapy, CDK4/6 inhibitors, and two to four lines of chemotherapy. The study met its primary endpoint, showing a statistically significant improvement in progression-free survival versus physician's choice of chemotherapy. The trial was designed to detect a 30% reduction in the risk of progression or death, and the company describes the PFS result as consistent with the earlier Phase 1/2 IMMU-132-01 study. Overall survival, a key secondary endpoint, showed only a numerical trend toward improvement at the first interim analysis and was not statistically significant; follow-up continues with a final OS readout expected in 2024. For investors, the readout opens a potential new indication for Trodelvy, but the path to approval is uncertain. Gilead states that Trodelvy is not approved for this indication, that it will explore pathways with regulators, and that it has not yet commented on whether PFS is clinically meaningful in this population. The company reiterated its 2022 guidance, noting no TROPiCS-02-related launches were assumed before late 2022. It did flag a possible impact on in-process R&D balance-sheet value that could affect GAAP EPS guidance, to be updated on the Q1 call. Gilead also reaffirmed its goal that one-third of revenue come from oncology by 2030. The filing is a Regulation FD disclosure, furnished rather than filed, and its exhibits include a press release and a Q&A document. The safety profile was consistent with prior studies, with no new safety concerns, though Trodelvy carries a boxed warning for severe neutropenia and diarrhea.

Mar 7, 2022 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Feb 1, 2022)

Gilead Sciences reported fourth quarter and full year 2021 results on February 1, 2022, with full-year total revenue of $27.3 billion (up 11%) and diluted GAAP EPS of $4.93, versus $0.10 in 2020. The headline figures are heavily distorted by one-time items. Fourth quarter GAAP diluted EPS fell to $0.30 from $1.23, driven by a $1.25 billion legal settlement charge (about $0.80 per share) and a $625 million charge tied to the Arcus Biosciences collaboration opt-in (about $0.38 per share). Non-GAAP diluted EPS for the quarter was $0.69 versus $2.19 a year earlier, and full-year non-GAAP EPS rose 3% to $7.28. Underlying demand was healthier than the headline decline suggests: fourth quarter product sales excluding Veklury grew 8% to $5.8 billion, led by Biktarvy (up 22%), while Veklury sales fell 30% as COVID-19 demand eased. The key investor concern is the durability of revenue as COVID-19 treatment sales normalize. Veklury contributed $5.6 billion in 2021, roughly 20% of product sales, and management guided to only about $2.0 billion in 2022, citing a step-down in hospitalization rates after the recent surge. Full-year 2022 guidance calls for total product sales of $23.8 to $24.3 billion, GAAP diluted EPS of $4.70 to $5.20, and non-GAAP diluted EPS of $6.20 to $6.70. Management is also pivoting toward growth drivers: Biktarvy, Trodelvy, Yescarta and Tecartus, with a Yescarta second-line LBCL decision (PDUFA April 1, 2022) pending. Capital allocation was active, with $1.0 billion of debt repaid and $894 million paid in dividends in the quarter, and free cash flow reached $10.8 billion for the year. Risks to monitor include two clinical holds affecting the lenacapavir HIV program, a partial clinical hold on magrolimab in combination with azacitidine, and continued HCV sales erosion (down 9% for the year). Investors should also note the Truvada and Atripla loss of exclusivity in the US, which reduced those product sales by 74% and 58% respectively in 2021. The company is scheduled to hold a Virology Deep-Dive on February 17, 2022 and an Oncology Deep-Dive on April 14, 2022.

Feb 1, 2022 8-K

Earnings & Results

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Feb 1, 2022)

Gilead Sciences, Inc. (GILD) announced a significant settlement with ViiV Healthcare, resolving all disputes related to the sales of its key HIV medication, Biktarvy®. This agreement, effective January 31, 2022, includes a one-time payment of $1.25 billion and an ongoing royalty of 3% on U.S. sales of Biktarvy® and bictegravir-containing products until October 2027. Gilead has already recorded a $1.25 billion pre-tax charge in the fourth quarter of 2021 related to this settlement. This settlement grants Gilead a broad worldwide license and covenant not to sue concerning bictegravir, the active ingredient in Biktarvy®. While the upfront payment and ongoing royalties represent a financial impact, this resolution eliminates ongoing litigation and potential future liabilities, providing clarity and stability for Gilead's Biktarvy® business. Investors should note the financial impact of the settlement charge and the ongoing royalty structure as factors in future profitability and cash flow.

Feb 1, 2022 8-K

Leadership Changes

GILEAD SCIENCES, INC. 8-K Report, Executive Changes (Jan 6, 2022)

Gilead Sciences, Inc. (GILD) announced on January 6, 2022, that Brett A. Pletcher, Executive Vice President, Corporate Affairs, General Counsel and Corporate Secretary, plans to retire. While no specific retirement date has been set, Mr. Pletcher is expected to continue in his current capacity while the company searches for and onboards a successor, with the transition anticipated by the end of summer 2022. This filing is significant for investors as it signals a leadership change in a key legal and corporate affairs role. While the departure is not immediate and includes a transition period, investors will likely monitor the selection of a new General Counsel to ensure continuity and a smooth handover of responsibilities. The company's ability to attract a strong successor will also be a point of interest.

Jan 6, 2022 8-K

Earnings & ResultsOther EventsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Oct 28, 2021)

Gilead Sciences reported strong third quarter 2021 results, with total revenue of $7.4 billion, up 13% year-over-year, driven primarily by Veklury (remdesivir) sales of $1.9 billion. GAAP diluted EPS rose to $2.05 from $0.29 a year earlier, aided by much lower acquired IPR&D expense ($19 million versus $1.17 billion) and smaller unrealized losses on equity securities. Non-GAAP diluted EPS increased 26% to $2.65. Excluding Veklury, product sales declined 3% to $5.4 billion, reflecting the expected U.S. loss of exclusivity for Truvada and Atripla, though Biktarvy hit a record $2.3 billion (up 20%) and Trodelvy and cell therapy continued to grow. Full-year 2021 guidance was raised substantially. Total product sales are now expected at $26.0–26.3 billion (versus $24.4–25.0 billion previously), with Veklury sales of $4.5–4.8 billion, up from $2.7–3.1 billion. Management flagged that the pandemic-driven Veklury lift is expected to step down in the fourth quarter as hospitalization rates fall, and that product sales excluding Veklury were lowered slightly to about $21.5 billion. Non-GAAP EPS guidance moved to $7.90–8.10. Investors should weigh the one-time nature of Veklury demand against the durable growth in HIV (Biktarvy), oncology, and the pipeline (lenacapavir NDA with a February 28, 2022 PDUFA date). Separately, Gilead announced a notice of redemption for $1.0 billion of 2023 notes (the $500 million floating rate notes and $500 million 0.750% notes), with a November 8, 2021 redemption date at 100% of principal plus accrued interest. The company also declared a $0.71 quarterly dividend for Q4 2021, payable December 30, 2021. Cash, equivalents and marketable securities were $6.8 billion at quarter-end, down from $7.9 billion at year-end 2020, following $2.5 billion in debt repayments and $900 million in dividends during the quarter.

Oct 28, 2021 8-K

Earnings & ResultsExhibits & Filings

GILEAD SCIENCES, INC. 8-K Report, Financial Results (Jul 29, 2021)

Gilead Sciences reported second-quarter 2021 results on July 29, 2021, with total revenue of $6.2 billion, up 21% year-over-year, driven primarily by Veklury (remdesivir) sales of $829 million and continued strength in Biktarvy, which grew 24%. Excluding Veklury, product sales rose 5% to $5.3 billion, reflecting Trodelvy and Tecartus uptake and improving HIV and HCV trends, partly offset by loss of exclusivity for Truvada and Atripla in the U.S. GAAP diluted EPS was $1.21 versus a loss of $2.66 a year earlier, which was distorted by a large acquired IPR&D charge in Q2 2020 tied to the Forty Seven acquisition. Non-GAAP diluted EPS rose 68% to $1.87. Quality of earnings warrants attention. GAAP SG&A rose to $1.35 billion, largely due to a significant donation of equity securities to the Gilead Foundation (about $220 million excluded from non-GAAP). Non-GAAP product gross margin expanded to 86.4%, and non-GAAP operating margin reached 51.1%. Cash flow was solid, with operating cash flow of $2.3 billion and free cash flow of $2.2 billion, though cash and marketable securities declined to $7.4 billion from $7.9 billion at year-end 2020, and the company paid $894 million in dividends. Gilead raised the low end of its full-year 2021 guidance for total product sales to $24.4-25.0 billion (from $23.7-25.1 billion) and raised Veklury sales expectations to $2.7-3.1 billion, while lowering the non-Veklury product sales outlook to $21.7-21.9 billion, citing a longer pandemic impact on HIV. GAAP EPS guidance was narrowed to $4.70-5.05 and non-GAAP EPS to $6.90-7.25, with the non-GAAP range midpoint slightly lower than before. Pipeline news was broad, including ZUMA-7 positive top-line data for Yescarta in second-line large B-cell lymphoma, an NDA filed for lenacapavir, and a Tecartus PDUFA date of October 1, 2021.

Jul 29, 2021

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