Published
# Gilead Sciences, Inc. (GILD) — Business, Risks and Management's Discussion
Fiscal period: FY2026 Q2 (quarter ended June 30, 2026)
Sources: Annual Report on Form 10-K for the year ended December 31, 2025 (SEC accession
0000882095-26-000006, filed February 24, 2026); Quarterly Report on Form 10-Q for the quarter
ended June 30, 2026 (accession 0000882095-26-000031, filed August 6, 2026); and Current Reports
on Form 8-K filed February 23, 2026 (accession 0001104659-26-018314), April 28, 2026 (accession
0001104659-26-049874), May 20, 2026 (accession 0001104659-26-064518) and August 4, 2026
(accession 0000882095-26-000028).
---
## Business
*From the FY2025 Form 10-K, accession 0000882095-26-000006.*
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes
medicines for HIV, viral hepatitis and other liver disease, COVID-19, cancer and, increasingly,
inflammatory disease. It operates in more than 35 countries, is headquartered in Foster City,
California, and had approximately 17,000 employees as of December 31, 2025. The 2025 commercial
portfolio comprised more than 25 therapies. Gilead reports as a single operating segment; the
economically meaningful units are its therapeutic franchises.
**HIV — the core franchise.** HIV products generated $20.8 billion of the company's $28.9 billion
of 2025 product sales, roughly 72% of the total.
- *Biktarvy* (bictegravir/emtricitabine ("FTC")/tenofovir alafenamide ("TAF")), a once-daily
single-tablet treatment regimen, alone produced $14.3 billion in 2025 — about half of total
company product sales.
- *Descovy* (FTC/TAF), approved both for treatment in combination with other antiretrovirals and
for pre-exposure prophylaxis ("PrEP"), produced $2.8 billion.
- *Genvoya* ($1.5 billion) and *Odefsey* ($1.2 billion) are older single-tablet regimens now
losing patients to Biktarvy.
- *Symtuza* is commercialized by Janssen; Gilead receives a revenue share for the cobicistat, FTC
and TAF components ($495 million in 2025).
- *Sunlenca* (lenacapavir), a capsid inhibitor dosed twice yearly, is approved for heavily
treatment-experienced adults with multidrug-resistant HIV-1. *Yeztugo* (lenacapavir) was
approved by FDA in 2025 for PrEP — the first and only twice-yearly PrEP option in the U.S. —
and authorized in the EU as *Yeytuo*.
**Liver disease** ($3.2 billion in 2025) spans hepatitis C (*Epclusa*, plus an authorized generic
sold through Gilead's separate subsidiary Asegua Therapeutics), hepatitis B (*Vemlidy*),
hepatitis delta (*Hepcludex*/bulevirtide) and primary biliary cholangitis (*Livdelzi*/seladelpar,
acquired with CymaBay in 2024).
**Oncology** ($3.2 billion in 2025) has two parts. Cell therapy — the CAR T-cell products
*Yescarta* (large B-cell lymphoma, follicular lymphoma) and *Tecartus* (mantle cell lymphoma,
B-cell ALL) — generated $1.8 billion and is declining under in-class and out-of-class
competition. *Trodelvy* (sacituzumab govitecan-hziy), a Trop-2-directed antibody-drug conjugate
acquired with Immunomedics, generated $1.4 billion in metastatic triple-negative and HR+/HER2-
breast cancer.
**Other** ($799 million) includes the antifungal *AmBisome* and residual products; *Veklury*
(remdesivir) for COVID-19 is reported separately and fell to $911 million in 2025 as
hospitalizations declined.
**How the money is collected.** Gilead sells most U.S. product exclusively through the wholesale
channel; historically approximately 90% of U.S. gross product sales have gone to three
wholesalers — Cardinal Health, Cencora and McKesson — and their specialty distributor
affiliates. Outside the U.S. it sells through its own commercial teams, third-party distributors
or partners. A very large share of gross price never reaches revenue: gross-to-net deductions
(Medicare and Medicaid rebates, 340B discounts, chargebacks, co-pay assistance, distributor fees)
were $19.95 billion in 2025, 41% of gross product sales, up from 38% in 2024, of which rebates
and chargebacks alone were $17.5 billion.
**Research and development.** R&D is focused on virology, oncology and inflammation, with over 50
clinical-stage programs. Clinical trial execution is heavily outsourced to contract research
organizations. Late-stage programs described in the 10-K include: a once-yearly lenacapavir
injection for PrEP; an oral bictegravir/lenacapavir combination for virologically suppressed
patients; an oral islatravir/lenacapavir combination with Merck; bulevirtide for hepatitis delta;
anitocabtagene autoleucel ("anito-cel"), a BCMA-directed CAR T-cell therapy for relapsed/
refractory multiple myeloma developed with Arcellx; sacituzumab govitecan in first-line breast
cancer alone and with Merck's pembrolizumab; axicabtagene ciloleucel in earlier lines; and
domvanalimab plus zimberelimab with Arcus Biosciences in first-line non-small cell lung cancer
("NSCLC").
**Patents and exclusivity.** The value of the franchise turns on a handful of dates. Estimated
expirations of primary compound patents (U.S. / EU), including extensions and pediatric
exclusivity where granted:
| Product | U.S. | EU |
|---|---|---|
| Biktarvy | 2036 | 2033 |
| Descovy | 2031 | 2027 |
| Odefsey | 2032 | 2027 |
| Genvoya | 2029 | 2028 |
| Vemlidy | 2031 | 2027 |
| Sunlenca | 2037 | 2037 |
| Yeztugo / Yeytuo | 2037 | 2037 |
| Epclusa | 2033 | 2032 |
| Livdelzi | 2025 (FDA Orphan Drug Exclusivity to 2031) | ten years of regulatory/market exclusivity expected on approval |
| Veklury | 2036 | 2035 |
| Yescarta | 2031 | composition-of-matter patent expired |
| Tecartus | 2027 | composition-of-matter patent expired |
| Trodelvy | 2028 (U.S. regulatory exclusivity to 2032) | 2029 |
For product candidates, lenacapavir runs to 2037 in both the U.S. and EU, anito-cel to an
estimated 2038 in the U.S., and bulevirtide to 2030/2029.
Several of these dates rest on litigation settlements rather than patent life alone. In October
2025 Gilead settled Biktarvy patent litigation with Lupin, Cipla and Laurus Labs; under those
agreements, subject to standard acceleration provisions, no U.S. generic entry for full-dose
Biktarvy is expected before April 1, 2036 — more than two years later than the company's prior
loss-of-exclusivity projection of December 2033. Earlier settlements govern TAF (Descovy, Vemlidy,
Odefsey) and cobicistat (Genvoya, Stribild); a 2025 settlement with Apotex/MSN licenses certain
Genvoya patents beginning August 6, 2032, or earlier in certain circumstances.
**Manufacturing.** Gilead owns or leases plants in Foster City, La Verne, Oceanside, El Segundo
and Santa Monica (California), Frederick (Maryland), Cork and Dublin (Ireland), Edmonton (Canada)
and Hoofddorp (Netherlands), with cell therapy concentrated in California, Maryland and the
Netherlands. Most active pharmaceutical ingredient and drug product manufacturing and testing is
performed by contract manufacturing organizations and contract testing laboratories, with primary
and back-up suppliers used for most products including HIV. The company has announced a planned
$32 billion investment in U.S. manufacturing and R&D through 2030.
**Regulation and pricing.** Products require FDA, EMA/European Commission or equivalent approval,
and manufacturing sites are subject to periodic inspection under current Good Manufacturing
Practices. Cell therapies carry additional obligations for chain of identity and custody and, in
the past, Risk Evaluation and Mitigation Strategy requirements. A significant portion of sales is
subject to statutory discounts — Medicare and Medicaid rebates and 340B ceiling prices — so U.S.
list-price increases have limited effect on net sales. The company is also subject to healthcare
fraud-and-abuse, false claims, anti-kickback and anti-bribery regimes.
---
## Risk factors
*From the FY2025 Form 10-K, accession 0000882095-26-000006, as updated in Part II, Item 1A of the
Q2 2026 Form 10-Q, accession 0000882095-26-000031. Condensed to the substantive risks.*
**Concentration in HIV.** A substantial portion of revenue comes from HIV treatment and
prevention. Loss of share to competing products or generics, or failure to introduce new HIV
medicines, would force the company to scale back operations including R&D.
**Drug pricing and reimbursement — the most active risk area.**
- *Inflation Reduction Act.* In January 2026 the Department of Health and Human Services selected
**Biktarvy** for Maximum Fair Price determination under Medicare, effective beginning in 2028.
Gilead anticipates the negotiated Medicare price will be **substantially lower** than the price
it currently charges in Medicare, and that it may also raise Medicaid rebates and lower 340B
ceiling prices. More products may be selected. The IRA's Part D redesign already increases
manufacturer discounts (10% in the initial coverage phase, 20% in the catastrophic phase) across
all beneficiaries including low-income subsidy patients.
- *Most-favored-nation pricing.* In December 2025 Gilead reached an agreement with the U.S.
administration to (1) exclude its branded products and associated ingredients from Section 232
tariffs for three years, provided it invests further in U.S. manufacturing; (2) implement MFN
prices in Medicaid for select existing products through the GENEROUS model and MFN prices in the
U.S. market for future launched products; (3) set a new direct-to-patient price for Epclusa; and
(4) return a portion of increased international revenues to the U.S. if the government succeeds
in raising drug prices abroad.
- *Tariffs.* Following a Section 232 investigation begun in April 2025, in April 2026 the U.S.
President issued a Proclamation imposing **100% tariffs on patented pharmaceutical products and
associated ingredients**, expected to take effect in the second half of 2026. Exemptions,
timing, scope and duration remain uncertain, and there is no assurance any exemption Gilead
qualifies for will persist.
- *Coverage.* The One Big Beautiful Bill Act imposes Medicaid work requirements and stricter
eligibility standards, mostly effective 2027; enhanced ACA premium subsidies lapsed at the end of
2025, which has already contributed to lower exchange enrollment. Both reduce covered lives.
- *340B.* Growth of the 340B program has pushed an increasing share of sales to deeply discounted
prices, in part through diversion and duplicate-discount violations. Gilead's contract-pharmacy
integrity initiative for branded HCV products, and analogous programs at other manufacturers, are
the subject of enforcement action and litigation; a growing number of states have enacted laws
requiring 340B pricing through contract pharmacies, which Gilead believes are invalid but is
litigating.
- *Cell therapy reimbursement.* The CMS DRG for inpatient CAR T reimbursement may not cover
hospitals' cost of care, which can limit access; EU reimbursement barriers similarly constrain
Yescarta and Tecartus uptake.
**Patents and generic entry.** Success depends on obtaining, defending and not infringing patents.
Generic manufacturers file abbreviated new drug applications against Gilead's products;
settlement agreements typically contain acceleration clauses permitting earlier entry in certain
circumstances. Generic entry has caused, and may again cause, share and price erosion.
**Cell therapy execution.** CAR T is a personalized manufacturing business: engineering each
patient's T cells, chemotherapy conditioning, and securing supply of side-effect medications such
as tocilizumab. Gilead depends on third-party apheresis centers, couriers and hospitals; FDA has
imposed class-wide labeling on CAR T therapies regarding secondary T-cell malignancies; and
in-house manufacturing in California, Maryland and the Netherlands must scale reliably.
**Clinical and pipeline risk, demonstrated repeatedly.** Late-stage failures have produced large
charges: the Phase 3 EVOKE-01 miss in previously treated metastatic NSCLC drove impairments of
$2.4 billion (Q1 2024) and $1.8 billion (Q3 2024); the Phase 3 ASCENT-07 study in HR+/HER2-
metastatic breast cancer missed its primary endpoint, reported with the fourth quarter of 2025;
competitive data on bulevirtide drove $190 million and $400 million impairments in 2025; and FDA
has placed a clinical hold on the HIV treatment trials of GS-1720 and/or GS-4182 (WONDERS-1 and
WONDERS-2).
**Forecasting and channel dynamics.** Demand is hard to predict — Veklury in particular tracks
COVID-19 hospitalization rates. The U.S. non-retail sector (AIDS Drug Assistance Programs, the VA,
correctional facilities, large HMOs) buys unevenly, and wholesaler and pharmacy inventory swings
can decouple reported sales from prescription demand, notably a second-half build followed by a
first-quarter draw-down.
**Manufacturing and supply.** Some products and materials are single-sourced or single-site.
Regulatory inspection findings can suspend operations. A significant share of raw materials and
intermediates comes from suppliers outside the U.S., exposing the company to trade rules and to
legislation such as the BIOSECURE Act and the proposed ABC Safe Drug Act.
**Litigation and government investigations.** These include HIV antitrust class actions and the
Aetna opt-out suit (trial scheduled January 2027); product liability claims involving
approximately 23,000 active plaintiffs alleging kidney, bone and tooth injuries from Viread,
Truvada, Atripla, Complera and Stribild; qui tam actions concerning HCV sales and marketing and
patient support programs; and ANDA litigation, including a February 2026 suit against Cipla in
Delaware over a 505(b)(2) application referencing Descovy.
**Importation, diversion and counterfeiting.** Price differentials across markets invite
importation (FDA authorized Florida's Canadian importation program in January 2024) and
parallel trade within the EU. Gilead has seized thousands of bottles of Gilead-labeled medication
with counterfeit supply-chain documentation sold by unauthorized distributors to independent
pharmacies.
**Strategic transactions and balance-sheet capacity.** Acquisitions, licenses, options and equity
investments may fail to deliver, and acquired intangibles are subject to impairment. Gilead has
paid substantial cash and incurred additional debt for these transactions; more indebtedness and a
lower cash balance could pressure credit ratings and reduce flexibility for capital investment,
buybacks and dividends.
**U.S. capital program.** The $32 billion U.S. investment through 2030 is exposed to construction
delays, cost inflation, labor availability, cGMP qualification and inspection, and may leave
underutilized assets or write-offs if returns do not materialize.
**Other named risks.** Global operations (a significant share of sales denominated in foreign
currencies, primarily the Euro; anti-bribery exposure; political instability including China,
Russia, Ukraine and Israel; expropriation and compulsory licensing); dependence on corporate
partners whose resourcing and priorities Gilead does not control; competition for specialized
scientific and technical personnel; information-system interruption and cybersecurity incidents
(the Kite Konnect platform is critical to cell therapy chain of identity, and acquired businesses
may carry undiscovered vulnerabilities), together with GDPR, CCPA and similar data-privacy
regimes; climate change and related natural disasters; reputational and stock-price risk from
corporate responsibility aspirations; pandemic and epidemic disruption; and effective tax rate
changes across the U.S., Germany and Ireland, including OECD Pillar Two.
---
## Management's discussion — fiscal year 2025
*From the FY2025 Form 10-K, accession 0000882095-26-000006.*
**Strategy.** Management's stated ambitions are to bring 10 or more transformative therapies to
patients by 2030 (tracked since 2020), to be a biotech employer and partner of choice, and to
deliver shareholder value sustainably. Priorities refreshed in late 2025: maximize the impact of
long-acting HIV therapies; accelerate the pipeline build in oncology and inflammation; adopt and
scale artificial intelligence; prioritize investments for highest impact; and strengthen
collaboration.
**Year in review.** 2025 delivered HIV growth, the launch of Yeztugo as the first and only
twice-yearly HIV PrEP option in the U.S., and share expansion for Livdelzi in primary biliary
cholangitis. Other notable events: positive Phase 3 ARTISTRY-1 and ARTISTRY-2 results for oral
bictegravir 75mg/lenacapavir 50mg, meeting non-inferiority against baseline multi-tablet regimens
and against Biktarvy; the Biktarvy generic settlements pushing expected U.S. entry to April 1,
2036; a CDC guideline recommendation for twice-yearly Yeztugo; a partnership with the U.S. State
Department and PEPFAR to supply lenacapavir for PrEP to up to two million people over three years;
EC authorization of Yeytuo; the FDA clinical hold on GS-1720/GS-4182; the definitive agreement to
acquire Arcellx; discontinuation of the Phase 3 STAR-221 study with Arcus in first-line gastric
and esophageal cancer; the ASCENT-07 miss; the ~$350 million acquisition of Interius
BioTherapeutics (in vivo CAR); collaborations with Pregene, Kymera and LEO Pharma; the agreement
with the U.S. government on drug pricing; and ground-breaking on a Foster City development and
manufacturing center within the planned $32 billion U.S. investment.
**Results.** Total revenues rose 2% to $29.4 billion. Product sales were $28.9 billion, up 1%;
royalty, contract and other revenues rose to $527 million, mainly from recognizing $400 million of
previously constrained revenue from a sale of intellectual property. By franchise:
| Franchise | 2025 | Change |
|---|---|---|
| HIV | $20,752M | +6% |
| Liver Disease | $3,217M | +6% |
| Veklury | $911M | (49)% |
| Cell Therapy | $1,839M | (7)% |
| Trodelvy | $1,397M | +6% |
| Other | $799M | (10)% |
| **Total product sales** | **$28,915M** | **+1%** |
HIV growth came from higher treatment and prevention demand with average realized price roughly
flat despite the Medicare Part D redesign; Biktarvy rose 7% to $14.3 billion on demand and
switching from Genvoya, partly offset by lower realized price from the Part D redesign, and
Descovy rose 31% to $2.8 billion. Liver disease grew on Livdelzi, hepatitis B and hepatitis delta
products, offset by lower realized price across the portfolio, most notably in HCV. Veklury fell
with COVID-19 hospitalizations. Cell therapy fell on competitive headwinds. Trodelvy grew on
breast cancer demand, partly offset by the bladder cancer indication withdrawal.
Approximately 26% of product sales were denominated in foreign currencies; currency net of hedges
was a $56 million favorable impact on product sales.
**Costs.** Cost of goods sold was $6,234 million and product gross margin 78.4%, roughly flat.
R&D fell 2% to $5,799 million as CymaBay integration and stock-compensation costs and restructuring
did not repeat. Acquired in-process R&D was $1,024 million (Interius $311 million; LEO Pharma
upfront $250 million; Pregene upfront and milestones $200 million) against $4,663 million in 2024
(dominated by the $3.8 billion CymaBay acquisition). In-process R&D impairments were $590 million,
both charges relating to bulevirtide ($190 million in Q2, $400 million in Q4) as competitive data
indicated a tougher market outside the EU — against $4.2 billion of Trodelvy NSCLC impairments in
2024. SG&A fell 5% to $5,774 million: selling and marketing up on HIV promotion, general and
administrative down on lower corporate-initiative and legal costs and the absence of CymaBay
integration, partly offset by donations of equity securities to the Gilead Foundation.
Interest expense rose 5% to $1,024 million on higher balances and rate. Other income, net, was
$798 million, driven by net unrealized gains on equity securities (versus losses in 2024) and
higher interest income. Pre-tax income was $9,796 million; income tax expense $1,286 million; the
effective rate fell to 13.1% from 30.5%, helped by the absence of the non-deductible CymaBay
acquired IPR&D, a settlement with a tax authority over a prior-year legal entity restructuring
(approximately $450 million of tax benefit and a $530 million reduction in unrecognized tax
benefits recognized in Q4 2025) and non-taxable equity fair-value gains. Net income attributable
to Gilead was $8,510 million and diluted EPS $6.78, against $480 million and $0.38 in 2024, when
results were absorbed by the CymaBay charge and the NSCLC impairments.
**Liquidity.** Cash and equivalents were $7.6 billion and marketable debt securities $3.0 billion
at December 31, 2025. Operating cash flow was $10.0 billion, down 7% on inventory build, higher
tax payments (including the final $1.3 billion transition-tax installment) and receivable timing.
Investing used $4.8 billion, mainly marketable securities purchases and the Interius acquisition
and collaborations. Financing used $7.7 billion: $4.0 billion of dividends, $1.9 billion of
buybacks and $1.8 billion of debt repayment, with no new issuance to offset (2024 included $3.5
billion of net note proceeds). A $2.5 billion revolving credit facility maturing June 2029 was
undrawn. Capital priorities are stated as investing in the business and pipeline, select
partnerships and business development, growing the dividend over time, and repurchasing shares to
offset dilution and opportunistically reduce share count. The Board authorized a $5.0 billion
repurchase program in 2020 and a further $6.0 billion program in the third quarter of 2025. On
February 10, 2026 the Board declared a quarterly dividend of $0.82 per share.
**Critical estimates** are rebates and chargebacks (historically actual claims have varied by less
than 5% from estimates), valuation of intangible assets under probability-weighted discounted cash
flows, legal contingencies and income taxes.
**Outlook given with the 10-K.** For 2026, management expected continued overall product sales
growth led by HIV demand, partly offset by U.S. policy developments, lower Veklury sales on lower
COVID-19 hospitalization rates, and lower cell therapy sales on competitive headwinds. The R&D
portfolio included over 50 clinical-stage programs, with 2026 decisions expected on two first-line
breast cancer therapies and an additional HIV treatment option, alongside continued disciplined
operating expense management.
---
## Current quarter — three and six months ended June 30, 2026
*From the Q2 2026 Form 10-Q, accession 0000882095-26-000031, and the second-quarter results
furnished on Form 8-K, accession 0000882095-26-000028.*
**The quarter in one line:** a strong commercial quarter buried under $11.2 billion of acquired
in-process R&D charges from three acquisitions closed in the period.
**Revenue.** Total revenues rose 10% to $7,803 million; product sales rose 8% to $7,627 million
and 10% excluding Veklury. Six-month revenues were $14,763 million, up 7%.
| | Q2 2026 | Change | 6M 2026 | Change |
|---|---|---|---|---|
| HIV | $5,693M | +12% | $10,723M | +11% |
| — Biktarvy | $3,772M | +7% | $7,133M | +7% |
| — Descovy | $967M | +48% | $1,774M | +43% |
| — Yeztugo | $232M | from $15M | $397M | from $15M |
| Liver Disease | $877M | +10% | $1,644M | +6% |
| — Livdelzi | $167M | from $78M | $300M | from $118M |
| Veklury | $23M | (81)% | $167M | (60)% |
| Oncology | $873M | +3% | $1,683M | +5% |
| — Cell Therapy | $417M | (14)% | $824M | (13)% |
| —— Yescarta | $346M | (12)% | $679M | (13)% |
| —— Tecartus | $70M | (24)% | $146M | (15)% |
| — Trodelvy | $457M | +26% | $859M | +31% |
| Other (AmBisome and other products) | $161M | (20)% | $357M | (13)% |
| Total product sales | $7,627M | +8% | $14,574M | +7% |
| Royalty, contract and other | $176M | — | $189M | — |
| **Total revenues** | **$7,803M** | **+10%** | **$14,763M** | **+7%** |
HIV growth was led by higher average realized price and demand, with Biktarvy also helped by
favorable inventory dynamics and switching from Genvoya. Descovy's 48% quarterly gain came mainly
from realized price. Yeztugo's PrEP launch is scaling quickly, at $397 million in the first half.
Royalty and other revenue included $156 million of previously constrained revenue from an
intellectual property sale. Currency net of hedges was a $23 million favorable impact in the
quarter, $135 million in the half; approximately 25% of quarterly product sales were denominated
in foreign currencies.
**Costs and the loss.** Product gross margin was 79.3%, essentially flat year over year (79.3% for
the half, up 150 basis points on expiry of a royalty-related obligation). R&D rose 18% to $1,764
million on integration expenses, including $229 million of stock-based compensation tied to the
acquisitions, offset by lower oncology clinical study activity. SG&A rose 41% to $1,921 million,
including $332 million of acquisition-related stock-based compensation and higher HIV promotional
spend.
Acquired in-process R&D was $11,183 million in the quarter ($7.0 billion Arcellx, $3.1 billion
Tubulis, and $1.0 billion for Ouro Medicines net of Lakefront's $860 million share). A further
$1,750 million in-process R&D impairment wrote the NSCLC intangible acquired with Immunomedics to
zero after the June 2026 discontinuation of the Phase 3 EVOKE-03 study of Trodelvy with
pembrolizumab in first-line metastatic NSCLC.
Interest expense was $247 million, flat; other income, net, was $387 million on $343 million of
net gains from equity securities. The pre-tax loss was $10,254 million; income tax expense was
still $242 million because the acquired IPR&D charges are non-deductible, giving an effective rate
of (2.4)%. Net loss was $10,496 million and diluted loss per share $(8.45), against net income of
$1,960 million and $1.56 a year earlier. Non-GAAP diluted loss per share was $(6.75). For the six
months, net loss was $8,475 million and diluted loss per share $(6.82).
**Acquisitions closed in the quarter.** All three were accounted for as asset acquisitions,
expensed to acquired IPR&D rather than capitalized:
- **Arcellx, Inc.** — closed April 28, 2026 following a tender offer at **$115.00 per share in
cash plus one non-tradable contingent value right worth $5.00 per share** (approximately $300
million in aggregate), payable if cumulative worldwide net sales of anito-cel exceed $6.0 billion
from launch through December 31, 2029. The 10-Q records approximately **$6.4 billion of cash
consideration net of cash acquired** and a $7.0 billion acquired IPR&D charge; the company
reported aggregate funds used of approximately $7.1 billion including payments for options and
restricted stock units. Gilead's pre-existing $773 million equity stake in Arcellx was settled
in the transaction, and $375 million of stock-based compensation was recorded for cash-settled
unvested employee awards. The deal converts the prior co-development and co-commercialization
collaboration on anito-cel — a BCMA-directed CAR T-cell therapy for relapsed/refractory multiple
myeloma — into full ownership, and adds Arcellx's D-Domain BCMA binder.
- **Tubulis GmbH** — closed May 2026 for approximately **$3.2 billion in cash net of cash
acquired** ($3.15 billion of upfront consideration as reported), with former shareholders
eligible for up to approximately **$1.9 billion in future milestones**. A $3.1 billion acquired
IPR&D charge was recorded. The lead asset, TUB-040 (also designated GS-8824), is a
NaPi2b-directed topoisomerase-I inhibitor antibody-drug conjugate in Phase 1b/2 for
platinum-resistant ovarian cancer and NSCLC;
the deal also brings an ADC platform.
- **Ouro Medicines, LLC** — closed June 2026 for aggregate consideration of approximately **$1.9
billion**, comprising $1.6 billion of cash net of cash acquired and contingent consideration of
up to $500 million (fair value $277 million at acquisition). The lead asset is OM336
(gamgertamig), a clinical-stage BCMAxCD3 T cell engager for autoimmune disease. **Lakefront**
(formerly Galapagos NV) paid Gilead a non-refundable **$860 million** for 50% of the upfront
consideration and will share contingent milestones equally; Lakefront funds development before
registrational studies, later costs are shared equally, Gilead retains commercialization rights
and pays Lakefront royalties of 20% to 23% on gamgertamig net sales.
**Other clinical and regulatory developments reported with the quarter.** FDA accelerated approval
of Hepcludex for chronic hepatitis delta in adults — the first and only FDA-approved HDV treatment
in the U.S. — which moved the related $550 million in-process R&D intangible to finite-lived. FDA
approval of Trodelvy for first-line unresectable locally advanced or metastatic triple-negative
breast cancer, as monotherapy for patients who are not candidates for PD-(L)1 inhibitor therapy or
in combination with pembrolizumab for PD-L1-positive tumours (CPS ≥10), plus European Commission
authorization as monotherapy and a positive CHMP opinion for the pembrolizumab combination. FDA
full approval of Tecartus in relapsed/refractory mantle cell lymphoma. FDA acceptance under
priority review of the bictegravir/lenacapavir NDA for virologically suppressed patients, with a
target action date of **August 27, 2026**; acceptance of the anito-cel BLA in fourth-line-plus
relapsed/refractory multiple myeloma, target action date **December 23, 2026**; and acceptance of
a supplemental NDA for a once-weekly oral Yeztugo 300-mg tablet for PrEP, target action date
**February 2, 2027**. Positive Phase 3 ISLEND-1 and ISLEND-2 results with Merck for a once-weekly
oral islatravir/lenacapavir regimen, and positive Phase 3 IDEAL results for Livdelzi.
**Balance sheet and cash.** Cash and equivalents were $3.2 billion at June 30, 2026, against $10.6
billion of cash, equivalents and marketable debt securities at December 31, 2025. Six-month
operating cash flow was $6,117 million (up from $2,584 million on lower tax payments, higher
collections, the Lakefront payment and lower inventory spend). Investing used $8,577 million for
the three acquisitions, funded partly by liquidating the marketable securities portfolio.
Financing used $1,895 million. Year to date the company reported $11.3 billion of acquisition
outflows, $2.8 billion of debt repayments, $2.1 billion of dividends and $774 million of buybacks
against $4.1 billion of net debt proceeds.
Debt funding in the period: **$3.0 billion of senior unsecured notes issued in May 2026** — $500
million of 4.25% notes due 2028, $1.0 billion of 4.40% due 2029, $1.0 billion of 4.60% due 2031
and $500 million of 4.90% due 2034; a **one-year $4.7 billion senior unsecured term loan facility
entered in April 2026**, of which $1.1 billion was drawn and the remaining $3.6 billion of undrawn
commitments cancelled during the quarter; and repayment in March 2026 of $2.75 billion of senior
notes due that month. Total debt, net, was $26,246 million at June 30, 2026 versus $24,937 million
at December 31, 2025. The $2.5 billion revolver maturing June 2029 remained undrawn and all
covenants were met.
In the quarter Gilead paid $1.0 billion of dividends and repurchased $355 million of stock (2.7
million shares under the announced programs at an average of $130.58 across all purchases), with
approximately $6.0 billion remaining available under the programs at June 30, 2026.
**Guidance raised on August 4, 2026.** For full-year 2026 Gilead now expects product sales of
$30,100–$30,400 million (previously $30,000–$30,400 million); product sales excluding Veklury of
$29,800–$30,100 million (previously $29,400–$29,800 million); Veklury of approximately $300
million (previously approximately $600 million); GAAP diluted loss per share of $(3.75)–$(3.40)
(previously $(3.25)–$(2.85)); and non-GAAP diluted loss per share of $(0.65)–$(0.30) (previously
$(1.05)–$(0.65)). Guidance includes approximately $9.08 per share of impact from $11.1 billion of
acquired IPR&D charges for Arcellx, Tubulis and Ouro Medicines, net of the Lakefront collaboration
and related taxes. Management attributed the quarter to 10% base-business growth led by HIV,
Trodelvy and Livdelzi, and pointed to two potential further launches in oncology and HIV in the
second half.
---
## Subsequent events
*From the Q2 2026 Form 10-Q, accession 0000882095-26-000031 (filed August 6, 2026), and the
results announcement furnished on Form 8-K, accession 0000882095-26-000028.*
Gilead states that it evaluated subsequent events through the issuance date of the quarterly
report and identified no further events or transactions requiring disclosure beyond those
disclosed in the notes to the condensed consolidated financial statements. The events disclosed
as occurring after June 30, 2026 are:
- **Dividend.** In August 2026 the Board declared a quarterly dividend of **$0.82 per share**,
payable September 29, 2026 to stockholders of record at the close of business on September 15,
2026.
- **Product liability litigation resolved in Gilead's favor at the California Supreme Court.** In
**August 2026** the California Supreme Court ruled for Gilead in the tenofovir disoproxil
fumarate product liability litigation, concluding that plaintiffs' negligence claim could not
proceed as a matter of law and directing the trial court to enter a new order granting summary
judgment for Gilead on all causes of action. The first California state bellwether trial had
been stayed pending that appeal. The broader matter — one putative class action and various
product liability suits in California and Missouri involving approximately 23,000 active
plaintiffs alleging kidney, bone and tooth injuries from Viread, Truvada, Atripla, Complera and
Stribild — is not fully closed: in the California federal case Gilead agreed to a one-time
payment of approximately **$39 million** to a group of approximately 2,470 plaintiffs, and the
federal court has set a **March 2027** trial date for the first bellwether of the remaining
cases. In the Missouri putative class action, the district court denied class certification in
January 2026 and the Eighth Circuit denied interlocutory review.
- **Second-quarter results and raised full-year 2026 guidance**, announced August 4, 2026, as set
out in the preceding section.
No acquisitions, divestitures or financings were disclosed as occurring after June 30, 2026; the
three acquisitions (Arcellx, Tubulis, Ouro Medicines), the $3.0 billion note issuance and the $4.7
billion term loan facility all closed within the quarter or earlier in the year. Pending
regulatory decisions dated after the reporting period are the bictegravir/lenacapavir target action
date of August 27, 2026, the anito-cel target action date of December 23, 2026, and the once-weekly
oral Yeztugo target action date of February 2, 2027. Section 232 tariffs of 100% on patented
pharmaceutical products are expected to take effect in the second half of 2026, subject to the
three-year exclusion Gilead negotiated in December 2025.