GILD · GILEAD SCIENCES, INC.

440 filings

GILD SEC Filings

GILEAD SCIENCES, INC. - 440 total filings

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

Showing 1–50 of 440 filings

GILEAD SCIENCES, INC. Quarterly Report for Q2 Ended Jun 30, 2026

Gilead Sciences, Inc. (GILD) reported a net loss of $10.5 billion for the three months ended June 30, 2026, a significant shift from the $2.0 billion net income in the prior year period. This loss was primarily driven by substantial acquired in-process research and development (IPR&D) expenses totaling $11.2 billion related to key acquisitions, including Arcellx, Tubulis, and Ouro Medicines. Additionally, a $1.75 billion IPR&D impairment charge impacted results. Despite these significant non-recurring charges, total revenues grew by 10% to $7.8 billion, fueled by strong performance in HIV products like Biktarvy and Descovy, alongside growth in Trodelvy and Livdelzi. The company's balance sheet shows a considerable decrease in cash and cash equivalents, from $7.6 billion at the start of the year to $3.2 billion, reflecting the significant cash outflows for acquisitions. The substantial investment in R&D and strategic acquisitions highlights Gilead's commitment to expanding its pipeline, particularly in oncology and inflammation, though it has led to a reported net loss for the quarter. Investors should monitor the integration of these acquisitions and the progress of their underlying assets, as well as ongoing litigation risks.

Aug 6, 2026 8-K

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

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

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 10-Q

GILEAD SCIENCES, INC. Quarterly Report for Q1 Ended Mar 31, 2026

Gilead Sciences, Inc. reported robust financial results for the first quarter of 2026, with total revenues reaching $6.96 billion, a 4% increase year-over-year. This growth was primarily driven by strong performance in HIV products, particularly Biktarvy and Descovy, and continued momentum in oncology with Trodelvy. Net income surged by 54% to $2.02 billion, translating to diluted earnings per share of $1.61, also up 54% from the prior year. This significant improvement was bolstered by favorable net unrealized gains from equity securities and higher product sales, partially offset by increased selling, general, and administrative expenses. The company also announced significant strategic acquisitions in April 2026, including Arcellx for approximately $7.8 billion, Tubulis for up to $5.1 billion, and Ouro Medicines for approximately $2.2 billion. These strategic moves are expected to result in substantial acquired in-process R&D expenses in Q2 2026, which the company anticipates will lead to a net loss for the second quarter and the full year 2026.

May 7, 2026 8-K

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

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 10-K

GILEAD SCIENCES, INC. Annual Report, Year Ended Dec 31, 2025

Gilead Sciences, Inc. (GILD) reported solid financial results for the year ended December 31, 2025, with total revenues reaching $29.4 billion, a 2% increase over the prior year. This growth was primarily driven by strong performance in HIV and Liver Disease product sales, partially offset by a decline in Veklury sales and competitive headwinds in Cell Therapy. Net income saw a significant rebound to $8.5 billion, or $6.78 per diluted share, a substantial increase from $480 million in the previous year, largely due to the absence of significant IPR&D expenses incurred in 2024 and a reduction in IPR&D impairment charges. The company continues to advance its strategic priorities, focusing on maximizing long-acting HIV therapies, accelerating its oncology and inflammation pipelines, and leveraging artificial intelligence. Key developments in 2025 included positive Phase 3 results for bictegravir/lenacapavir (BIC/LEN) for HIV treatment, the acquisition of Arcellx to bolster its oncology pipeline, and the expansion of its liver disease portfolio with Livdelzi. Gilead also remains committed to returning value to shareholders through dividends and share repurchases, while maintaining disciplined operating expense management. The company anticipates continued revenue growth in 2026, though expects some impact from policy developments and ongoing competition.

Feb 24, 2026 8-K

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

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

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 10-Q

GILEAD SCIENCES, INC. Quarterly Report for Q3 Ended Sep 30, 2025

Gilead Sciences, Inc. reported solid financial results for the third quarter and first nine months of 2025, demonstrating revenue growth and a significant turnaround in profitability compared to the prior year. Total revenues for the third quarter of 2025 increased by 3% year-over-year to $7.8 billion, driven by strong performance in the HIV and Liver Disease segments, alongside a notable surge in royalty, contract, and other revenues. For the first nine months, total revenues grew 2% to $21.5 billion. The company achieved substantial net income of $3.1 billion for the quarter and $6.3 billion for the nine-month period, a significant improvement from the net loss reported in the comparable periods of 2024. This profitability boost was largely attributed to the absence of substantial impairment charges seen in the prior year, coupled with increased royalty income and lower acquired R&D expenses. Diluted earnings per share also saw a strong recovery, reflecting these improved financial outcomes.

Nov 7, 2025 8-K

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

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

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 10-Q

GILEAD SCIENCES, INC. Quarterly Report for Q2 Ended Jun 30, 2025

Gilead Sciences, Inc. reported solid financial performance for the second quarter of fiscal year 2025, with total revenues reaching $7.08 billion, a 2% increase year-over-year. This growth was primarily driven by strong performance in the HIV segment, particularly from Biktarvy and Descovy sales, which saw significant increases. The company also experienced growth in Trodelvy sales within its Oncology segment. Net income attributable to Gilead surged by 21% to $1.96 billion, with diluted earnings per share rising to $1.56. This improvement was bolstered by higher product sales and a favorable swing in unrealized gains on equity securities compared to the prior year. However, the company did incur a $190 million impairment charge related to its bulevirtide IPR&D intangible asset due to increased market competition. Despite this, Gilead's robust product sales, particularly in HIV, and a more favorable equity investment performance contributed to a strong quarter.

Aug 7, 2025 8-K

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

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

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 10-Q

GILEAD SCIENCES, INC. Quarterly Report for Q1 Ended Mar 31, 2025

Gilead Sciences, Inc. reported a net income of $1.3 billion for the first quarter of 2025, a significant recovery from the $4.2 billion net loss in the prior year's quarter. This turnaround was largely driven by the absence of a substantial $3.9 billion acquired in-process R&D expense related to the CymaBay acquisition and a $2.4 billion IPR&D impairment charge recorded in Q1 2024, both of which did not recur. Total revenues remained stable at $6.7 billion, with a slight decrease of 1% in product sales, which was mitigated by an increase in royalty, contract, and other revenues. Key drivers of revenue performance included a 6% increase in HIV product sales, primarily from Biktarvy, and a 3% rise in Liver Disease products, boosted by the launch of Livdelzi. Conversely, Veklury sales saw a sharp decline of 45% due to lower COVID-19 related hospitalizations. Oncology sales experienced a slight decrease. The company continues to focus on its strategic priorities, including investing in its R&D pipeline and business development, while demonstrating a strong liquidity position with $7.9 billion in cash and cash equivalents as of March 31, 2025.

May 7, 2025 8-K

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

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 10-K

GILEAD SCIENCES, INC. Annual Report, Year Ended Dec 31, 2024

Gilead Sciences, Inc. (GILD) reported total revenues of $28.8 billion for the year ended December 31, 2024, representing a 6% increase compared to the previous year. This growth was primarily driven by strong performance in its HIV, Oncology, and Liver Disease segments. However, net income attributable to Gilead saw a significant decrease of 92% to $480 million, largely due to substantial impairment charges related to Trodelvy's non-small cell lung cancer (NSCLC) program ($4.2 billion) and higher expenses from the CymaBay acquisition ($3.8 billion). The company is strategically focused on maximizing revenue growth, capitalizing on long-acting HIV therapies, and expanding its oncology portfolio. Key product highlights include continued demand for Biktarvy and expansion of Livdelzi's indication. Looking ahead to 2025, Gilead anticipates continued demand growth for its products, but expects this to be tempered by the effects of the Inflation Reduction Act, a decline in Veklury sales due to reduced COVID-19 hospitalizations, and the impact of a strengthening U.S. dollar. The company maintains a robust R&D pipeline and continues to pursue strategic collaborations and business development opportunities.

Feb 28, 2025 8-K

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

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

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 10-Q

GILEAD SCIENCES, INC. Quarterly Report for Q3 Ended Sep 30, 2024

Gilead Sciences, Inc. reported strong revenue growth in the third quarter of 2024, with total revenues reaching $7.5 billion, a 7% increase year-over-year, driven primarily by robust performance in its HIV segment. This growth was partially offset by significant non-cash charges, including an $1.8 billion impairment related to the Trodelvy NSCLC IPR&D asset and higher acquired IPR&D expenses, which resulted in a net loss of $1.3 billion for the nine-month period. Despite the net loss, the company demonstrated positive operating cash flow, highlighting the underlying strength of its commercial operations and the ongoing demand for its key products. The company continues to strategically invest in its pipeline and expand its portfolio through acquisitions and collaborations. Notable developments include the FDA's accelerated approval of Livdelzi for primary biliary cholangitis and positive Phase 3 data for lenacapavir in HIV prevention, positioning Gilead for future growth. However, the company faces ongoing legal challenges and potential patent expirations, which remain key areas for investor attention.

Nov 12, 2024 8-K

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

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 10-Q

GILEAD SCIENCES, INC. Quarterly Report for Q2 Ended Jun 30, 2024

Gilead Sciences, Inc. (GILD) reported $6.95 billion in total revenues for the second quarter of 2024, a 5% increase compared to the same period last year. This growth was primarily driven by strong performance in HIV, Oncology, and Liver Disease segments. Diluted earnings per share (EPS) for the quarter were $1.29, a significant increase from $0.83 in Q2 2023, reflecting improved revenues and lower operating expenses. Despite a strong Q2 performance, the six-month period ending June 30, 2024, showed a net loss of $2.56 billion. This was largely attributable to a significant acquired in-process R&D charge of $3.9 billion related to the CymaBay acquisition and a $2.4 billion impairment charge on IPR&D assets for Trodelvy's NSCLC indication. The company also reported a decrease in cash and cash equivalents, primarily due to the CymaBay acquisition and dividend payments. Gilead's balance sheet remains robust, but investors should monitor the impact of significant R&D charges and ongoing litigation.

Aug 8, 2024 8-K

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

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 10-Q

GILEAD SCIENCES, INC. Quarterly Report for Q1 Ended Mar 31, 2024

Gilead Sciences, Inc. reported a net loss of $4.17 billion for the first quarter of 2024, a significant decrease from a net income of $1.01 billion in the prior year period. This loss was largely attributed to a substantial acquired in-process research and development (IPR&D) charge of $3.9 billion related to the acquisition of CymaBay Therapeutics and a $2.4 billion impairment charge for certain IPR&D assets connected to Trodelvy. Despite the net loss, total revenues saw a 5% increase year-over-year, reaching $6.69 billion. This growth was driven by strong performance in HIV and Oncology segments, with notable increases in Biktarvy and Trodelvy sales. However, Veklury sales experienced a decline, reflecting decreased COVID-19 related hospitalizations. Financial activities during the quarter included significant investments in acquisitions, notably the CymaBay purchase, and ongoing share repurchases and dividend payments, contributing to a decrease in cash and cash equivalents.

May 8, 2024 8-K

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

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

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 10-K

GILEAD SCIENCES, INC. Annual Report, Year Ended Dec 31, 2023

Gilead Sciences, Inc. reported total revenues of $27.1 billion for the fiscal year 2023, a slight decrease of 1% compared to 2022. This was primarily driven by a significant drop in Veklury (remdesivir) sales due to lower COVID-19 related hospitalizations, which was largely offset by robust growth in HIV and Oncology product sales. Net income attributable to Gilead increased by 23% to $5.7 billion, with diluted earnings per share rising 24% to $4.50. This improvement was largely due to lower impairment charges related to in-process research and development, reduced net unrealized losses on equity investments, and increased interest income. The company continues to strategically invest in its R&D pipeline through acquisitions and collaborations, particularly in oncology and inflammation. Key developments include expanded collaborations and the acquisition of smaller biotech firms to bolster its pipeline. Patent expirations for some key products are on the horizon, with major HIV products like Descovy and Vemlidy having U.S. patent expirations in 2031, and Biktarvy in 2033. The company also faces ongoing litigation, including challenges related to its HIV products and the sale of its PrEP medications, though recent legal outcomes have been favorable in some instances. Gilead maintains a strong liquidity position and continues to return capital to shareholders through dividends and share repurchases.

Feb 23, 2024 8-K

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

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

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 10-Q

GILEAD SCIENCES, INC. Quarterly Report for Q3 Ended Sep 30, 2023

Gilead Sciences, Inc. reported steady revenues for the third quarter and the first nine months of 2023, with total revenues reaching $7.05 billion and $20.0 billion, respectively, showing a slight increase of 1% year-over-year for the nine-month period. Net income attributable to Gilead saw significant growth, up 22% to $2.18 billion for the quarter and 44% to $4.24 billion for the nine months, driven by increased product sales in Oncology and HIV, along with a favorable year-over-year comparison due to the absence of a large IPR&D impairment charge recognized in the prior year. Product sales within the HIV segment demonstrated robust growth, particularly Biktarvy, contributing to a 4% increase in HIV product sales for the quarter. The Oncology segment also performed strongly, with significant year-over-year increases in both Cell Therapy (Yescarta and Tecartus) and Trodelvy sales, reflecting continued demand and successful market penetration. However, sales of Veklury, the company's COVID-19 treatment, declined substantially due to decreased COVID-19 hospitalizations and the availability of alternative treatments. The company also addressed a significant legal settlement related to HIV antitrust litigation, paying $525 million in the second half of the year, which impacted operating expenses.

Nov 7, 2023 8-K

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

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

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 10-Q

GILEAD SCIENCES, INC. Quarterly Report for Q2 Ended Jun 30, 2023

Gilead Sciences, Inc. (GILD) reported revenues of $6.60 billion for the third quarter of 2023, a 5% increase year-over-year, driven by growth in HIV and Oncology segments. However, net income attributable to Gilead saw a significant decrease of 9% to $1.045 billion, or $0.83 per diluted share. This decline was primarily influenced by a $525 million litigation accrual for settlements related to HIV antitrust litigation, coupled with higher operating costs and tax expenses. For the first six months of 2023, revenues grew 1% to $12.95 billion, while net income more than doubled to $2.06 billion, largely due to the absence of a significant $2.7 billion IPR&D impairment charge recognized in the prior year's comparable period. The company's strategic focus continues to be on advancing innovative medicines for life-threatening diseases. Acquisitions in the oncology space, such as XinThera and Tmunity, alongside collaborations like Arcellx, highlight Gilead's commitment to expanding its pipeline. Despite a challenging legal environment and increased R&D spending, Gilead's core HIV franchise remains robust, and its cell therapy and oncology products are demonstrating strong growth.

Aug 4, 2023 8-K

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

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 10-Q

GILEAD SCIENCES, INC. Quarterly Report for Q1 Ended Mar 31, 2023

Gilead Sciences, Inc. reported total revenues of $6.35 billion for the first quarter of 2023, a 4% decrease year-over-year, primarily due to lower sales of Veklury (remdesivir). However, the company saw strong growth in its oncology portfolio, with significant increases in Cell Therapy (up 64%) and Trodelvy (up 52%), driven by expanded adoption and new indications. HIV product sales also increased by 13%, indicating continued strength in this core franchise, bolstered by Biktarvy and Descovy for PrEP. Net income attributable to Gilead significantly improved to $1.01 billion, or $0.80 per diluted share, compared to $19 million, or $0.02 per diluted share, in the prior year. This substantial increase was largely driven by the absence of a $2.7 billion in-process research and development impairment charge recorded in Q1 2022. Gilead also made strategic investments, including the acquisition of Tmunity Therapeutics and a collaboration with Arcellx, signaling a continued focus on expanding its oncology pipeline. The company maintained a healthy operating cash flow of $1.74 billion.

May 3, 2023 8-K

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 10-K

GILEAD SCIENCES, INC. Annual Report, Year Ended Dec 31, 2022

Gilead Sciences, Inc. (GILD) reported relatively flat total revenues of $27.3 billion for the fiscal year ended December 31, 2022, compared to the prior year. This stability was driven by growth in key areas like HIV, cell therapy, and Trodelvy, which offset a significant decline in Veklury (remdesivir) sales due to lower COVID-19 hospitalization rates. However, net income saw a substantial decrease of 26% to $4.6 billion, largely impacted by a $2.7 billion impairment charge related to Trodelvy's in-process R&D, higher R&D expenses, and a one-time charge in the prior year for a bictegravir litigation settlement that did not recur. Despite the net income decline, the company continues to invest in its pipeline through strategic acquisitions and collaborations, and returned value to shareholders through dividends and share repurchases.

Feb 22, 2023