On August 4, 2026 Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, reported financial results for the second quarter of 2026.

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"We continued to make substantial progress across our business this quarter, driven by strong execution and growing contributions from new product launches," said Robert M. Davis, chairman and chief executive officer. "The FDA approval of LIPFENDRA is an exciting moment for our company and for patients, marking the latest milestone in our nearly 70-year legacy in cardiovascular disease. Together with key regulatory and clinical advances across oncology, HIV and immunology, this achievement reflects the strength of our pipeline and portfolio transformation as we bring forward the next wave of innovation. I am confident in the ongoing execution of our strategy as we deliver for patients and further enhance our long-term growth trajectory."

Financial Summary

$ in millions, except EPS amounts

Second Quarter

2026

2025

Change

Change Ex-

Exchange

Sales

$16,607

$15,806

5%

4%

GAAP net (loss) income2

(1,335)

4,427

N/M

N/M

Non-GAAP net (loss) income that excludes certain items2,3*

(330)

5,366

N/M

N/M

GAAP EPS

(0.54)

1.76

N/M

N/M

Non-GAAP EPS that excludes certain items3*

(0.13)

2.13

N/M

N/M

*Refer to table on page 7.

N/M – Not meaningful

For the second quarter of 2026, Generally Accepted Accounting Principles (GAAP) loss / earnings per share (EPS) assuming dilution was a loss per share of $0.54 and non-GAAP loss per share was $0.13. Both the GAAP and non-GAAP loss per share were due to a charge for the acquisition of Terns Pharmaceuticals, Inc. (Terns) of $2.31 per share. Both GAAP and non-GAAP EPS in the second quarter of 2025 include a charge of $0.07 per share for an upfront payment related to a license agreement with Jiangsu Hengrui Pharmaceutical Co., Ltd. (Hengrui Pharma).

Non-GAAP EPS excludes acquisition- and divestiture-related costs and costs related to restructuring programs, as well as income and losses from investments in equity securities. Non-GAAP EPS in the second quarter of 2025 also excludes tax benefits primarily resulting from favorable audit reserve adjustments.

Year-to-date results can be found in the attached tables.

Second-Quarter Sales Performance
The following table reflects sales of the Company’s top products and significant performance drivers.

Second Quarter

$ in millions

2026

2025

Change

Change Ex-Exchange

Commentary

Total Sales

$16,607

$15,806

5%

4%

Pharmaceutical

14,760

14,050

5%

4%

Increase primarily driven by growth in oncology as well as cardiometabolic and respiratory, partially offset by a decline in diabetes.

KEYTRUDA/
KEYTRUDA QLEX

8,366

7,956

5%

4%

Growth primarily driven by strong global uptake in earlier-stage indications, including triple-negative breast cancer (TNBC), cervical cancer, head and neck cancer and bladder cancer, as well as higher global demand in metastatic indications, including urothelial cancer. Sales of KEYTRUDA QLEX were $463 million.

GARDASIL/
GARDASIL 9

1,169

1,126

4%

3%

Increase primarily due to higher demand in Asia Pacific and Europe, as well as favorable timing of tenders in Europe, partially offset by lower demand in certain other international markets.

PROQUAD, M-M-R II and VARIVAX

592

609

-3%

-3%

Decrease primarily reflects lower demand in the U.S., partially offset by higher net pricing in the U.S., higher demand in Europe and favorable private-sector purchasing patterns for M-M-R II in the U.S.

WINREVAIR

588

336

75%

75%

Growth primarily reflects continued uptake in the U.S. and early launch uptake in certain international markets, particularly in Japan and Europe.

BRIDION

497

461

8%

8%

Growth primarily due to higher demand and net pricing in the U.S.

JANUVIA/JANUMET

429

623

-31%

-31%

Decline primarily due to lower demand and net pricing in the U.S. due to competition, as well as lower demand in China and most other international markets due to ongoing generic competition.

Lynparza*

365

370

-1%

-2%

Relatively flat compared with prior year.

PREVYMIS

295

228

29%

28%

Increase primarily due to higher demand in the U.S. and certain European markets, reflecting in part the launch of new indications.

Lenvima*

283

265

7%

6%

Growth primarily due to higher demand in the U.S., partially offset by lower net pricing.

WELIREG

271

162

67%

67%

Growth primarily driven by higher demand in the U.S. and continued launch uptake in several international markets, particularly in Japan, as well as favorable wholesaler purchasing patterns in the U.S.

OHTUVAYRE

204

–

–

–

Product obtained as part of the Company’s October 2025 acquisition of Verona Pharma plc. Includes a benefit from the timing of specialty pharmacy purchases in the U.S.

CAPVAXIVE

184

129

42%

40%

Increase primarily driven by launch uptake in several international markets, particularly in Asia Pacific and Europe, as well as in the U.S.

VAXNEUVANCE

148

229

-35%

-36%

Decline primarily due to favorable prior period public-sector activity in the U.S., which increased sales in that period, as well as lower demand in the U.S. and in most international markets in the current period due to competitive pressure.

LAGEVRIO

5

83

-95%

-95%

Decline largely due to lower demand in Japan and the U.S.

Animal Health

1,775

1,646

8%

5%

Growth attributable to both Livestock and Companion Animal product portfolios.

Livestock

1,041

961

8%

6%

Growth primarily driven by higher demand for ruminant and poultry products.

Companion Animal

734

685

7%

5%

Growth primarily due to new product launches. Sales of BRAVECTO line of products were $359 million and $335 million in the current and prior-year quarters, respectively, which represents an increase of 7%, or 4% excluding impact of foreign exchange.

Other Revenues**

72

110

-35%

-34%

Decline primarily due to lower revenue from third-party manufacturing arrangements.

*Alliance revenue for this product represents the Company’s share of profits, which are product sales net of cost of sales and commercialization costs.

**Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities.

Second-Quarter Expense and Related Information
The table below presents selected expense information.

$ in millions

GAAP

Acquisition-
and
Divestiture-
Related Costs4

Restructuring
Costs

(Income)
Loss From
Investments
in Equity
Securities

Non-
GAAP3

Second Quarter 2026

Cost of sales

$4,395

$1,067

$184

$-

$3,144

Selling, general and administrative

2,904

17

–

–

2,887

Research and development

9,741

6

(1)

–

9,736

Restructuring costs

151

–

151

–

–

Other (income) expense, net

99

–

–

(191)

290

Second Quarter 2025

Cost of sales

$3,557

$576

$165

$-

$2,816

Selling, general and administrative

2,649

15

1

–

2,633

Research and development

4,048

3

53

–

3,992

Restructuring costs

560

–

560

–

–

Other (income) expense, net

(7)

–

–

(61)

54

GAAP Expense, EPS and Related Information
Gross margin was 73.5% for the second quarter of 2026 compared with 77.5% for the second quarter of 2025. The decrease was primarily due to higher amortization of intangible assets and inventory write-downs.

Selling, general and administrative (SG&A) expenses were $2.9 billion in the second quarter of 2026, an increase of 10% compared with the second quarter of 2025. The increase was primarily due to higher administrative costs (including investments in IT), as well as higher promotional costs in support of product launches.

Research and development (R&D) expenses were $9.7 billion in the second quarter of 2026 compared with $4.0 billion in the second quarter of 2025. The increase was largely due to a $5.7 billion charge for the acquisition of Terns and higher clinical development spending, partially offset by a $200 million reduction in R&D expenses as part of a funding agreement with Blackstone Life Sciences (Blackstone). R&D expenses in the second quarter of 2025 include a $200 million charge for an upfront payment related to a license agreement with Hengrui Pharma.

Other (income) expense, net, was $99 million of expense in the second quarter of 2026 compared with $7 million of income in the second quarter of 2025. The unfavorability was primarily due to higher net interest expense, partially offset by higher net income from investments in equity securities.

The income tax provision for the second quarter of 2026 was $654 million on a pretax loss of $683 million, resulting in an effective income tax rate of (95.9)%. This effective income tax rate includes a 108.9 percentage point unfavorable impact of the charge for the acquisition of Terns, for which no tax benefit was recorded.

GAAP loss per share was $0.54 for the second quarter of 2026 compared with earnings per share of $1.76 for the second quarter of 2025, largely due to higher charges for business development transactions, reflecting a $2.31 per share charge in the second quarter of 2026 for the acquisition of Terns compared with a $0.07 per share charge in the second quarter of 2025 related to a license agreement with Hengrui Pharma.

Non-GAAP Expense, EPS and Related Information
Non-GAAP gross margin was 81.1% for the second quarter of 2026 compared with 82.2% for the second quarter of 2025. The decrease was primarily due to higher inventory write-downs.

Non-GAAP SG&A expenses were $2.9 billion in the second quarter of 2026, an increase of 10% compared with the second quarter of 2025. The increase was primarily due to higher administrative costs (including investments in IT), as well as higher promotional costs in support of product launches.

Non-GAAP R&D expenses were $9.7 billion in the second quarter of 2026 compared with $4.0 billion in the second quarter of 2025. The increase was largely due to a $5.7 billion charge for the acquisition of Terns and higher clinical development spending, partially offset by a $200 million reduction in R&D expenses as part of a funding agreement with Blackstone. R&D expenses in the second quarter of 2025 include a $200 million charge for an upfront payment related to a license agreement with Hengrui Pharma.

Non-GAAP other (income) expense, net, was $290 million of expense in the second quarter of 2026 compared with $54 million of expense in the second quarter of 2025. The unfavorability was primarily due to higher net interest expense.

The non-GAAP income tax provision for the second quarter of 2026 was $882 million on pretax income of $550 million, resulting in a non-GAAP effective income tax rate of 160.3%. This effective income tax rate includes a 146.2 percentage point unfavorable impact of the charge for the acquisition of Terns, for which no tax benefit was recorded.

Non-GAAP loss per share was $0.13 for the second quarter of 2026 compared with earnings per share of $2.13 for the second quarter of 2025, largely due to higher charges for business development transactions, reflecting a $2.31 per share charge in the second quarter of 2026 for the acquisition of Terns compared with a $0.07 per share charge in the second quarter of 2025 related to a license agreement with Hengrui Pharma.

A reconciliation of GAAP to non-GAAP net (loss) income and EPS is provided in the table that follows.

Second Quarter

$ in millions, except EPS amounts

2026

2025

EPS

GAAP EPS

$(0.54)

$1.76

Difference

0.41

0.37

Non-GAAP EPS that excludes items listed below3

$(0.13)

$2.13

Net (Loss) Income

GAAP net (loss) income2

$(1,335)

$4,427

Difference

1,005

939

Non-GAAP net (loss) income that excludes items listed below2,3

$(330)

$5,366

Excluded Items:

Acquisition- and divestiture-related costs4

$1,090

$594

Restructuring costs

334

779

Income from investments in equity securities

(191)

(61)

Increase to net loss / decrease to net income before taxes

1,233

1,312

Estimated income tax benefit5

(228)

(373)

Increase to net loss / decrease to net income

$1,005

$939

Pipeline and Portfolio Highlights

In the second quarter, the Company achieved key regulatory milestones across the portfolio while continuing to advance its broad and diverse pipeline.

Oncology:
U.S. Food and Drug Administration (FDA) approved KEYTRUDA and KEYTRUDA QLEX, each with WELIREG, for the adjuvant treatment of certain patients with clear cell renal cell carcinoma (ccRCC), based on Phase 3 LITESPARK-022 trial.
Approvals represent first approved combination of a PD-1 and hypoxia-inducible factor-2 alpha inhibitor for these patients.
In July, FDA approved expanded use of KEYTRUDA and KEYTRUDA QLEX, each with Padcev, as treatment before and after surgery for adult patients with muscle-invasive bladder cancer (MIBC), including cisplatin eligible patients based on Phase 3 KEYNOTE-B15 trial; the expansion builds upon prior approval of this regimen for cisplatin ineligible patients based on Phase 3 KEYNOTE-905 trial.
FDA approved KEYTRUDA and KEYTRUDA QLEX, each with Trodelvy, for the first-line treatment of PD-L1 positive (Combined Positive Score [CPS] ≥10) advanced TNBC, based on Phase 3 KEYNOTE-D19/ASCENT-04 trial.
FDA granted Breakthrough Therapy designation (BTD) for calderasib (MK-1084), an investigational oral specific KRAS G12C inhibitor, in combination with KEYTRUDA, for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C-mutation and expressing PD-L1 (tumor proportion score [TPS] ≥1%).
Announced that Phase 3 TroFuse-005 trial evaluating sac-TMT, an investigational anti-TROP2 antibody-drug conjugate (ADC) being developed in collaboration with Kelun-Biotech, met its primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with advanced or recurrent endometrial cancer who have progressed after platinum-based chemotherapy and anti-PD-1/L1 immunotherapy.
First Phase 3 results from the Company’s broad sac-TMT clinical development program, which includes 17 ongoing global Phase 3 trials across multiple tumor types.
At the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, new research was presented across over 25 types of cancer, reinforcing long-term impact of KEYTRUDA and momentum in the Company’s rapidly advancing oncology pipeline, including:
Five-year follow-up data from Phase 2b KEYNOTE-942 trial, in collaboration with Moderna, underscoring continued potential of intismeran autogene (mRNA-4157/V940) in combination with KEYTRUDA for patients with stage III/IV melanoma following complete resection.
Data from Phase 3 OptiTROP-Lung05 trial, led by Kelun-Biotech, evaluating sac-TMT plus KEYTRUDA in China, adding to ongoing research of novel treatment approaches for patients with NSCLC.
Results from final analysis of KEYNOTE-522 evaluating KEYTRUDA in combination with chemotherapy, reporting a continued survival benefit for patients with high-risk early-stage TNBC.
Vaccines and Infectious Diseases:
In July, presented new data for daily and weekly options across HIV treatment and prevention pipeline at 26th International AIDS Conference (AIDS 2026). Hosted HIV investor event to highlight these data.
In collaboration with Gilead, presented first Phase 3 results for islatravir/lenacapavir (ISL/LEN), an investigational oral once-weekly single-tablet HIV treatment regimen, which maintained virological suppression in adults with HIV who switched antiretroviral therapy. ISL/LEN has the potential to be the first approved oral, once-weekly HIV treatment.
Presented first results from a Phase 2b study evaluating switch to investigational once-weekly oral islatravir and ulonivirine (ISL/ULO) in adults with virologically suppressed HIV-1.
Received regulatory approvals in Japan and China for ENFLONSIA for the prevention of RSV lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season.
Cardiometabolic and Respiratory:
In July, FDA approved LIPFENDRA (enlicitide), the first and only once-daily oral PCSK9 inhibitor, as an adjunct to diet and exercise, to reduce LDL-C in adults with hypercholesterolemia, based on two Phase 3 trials from the CORALreef clinical program: CORALreef Lipids and CORALreef HeFH.
At week 24, LIPFENDRA significantly reduced LDL-C by a placebo-adjusted 56% and 59%, respectively.
Immunology:
Announced positive topline results from Phase 3 ATLAS-UC induction-only study (Study 2) evaluating tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A (TL1A), in patients with moderately to severely active ulcerative colitis (UC).
Initial topline results from primary analyses of two Phase 2 studies evaluating tulisokibart:
In hidradenitis suppurativa (HS), the study met its primary and key secondary endpoints. Full results will be shared at an upcoming medical meeting.
In systemic sclerosis-associated interstitial lung disease (SSc-ILD), the study did not meet its primary endpoint and will be discontinued. No new safety concerns were identified.
Business Development:
Completed acquisition of Terns for $6.8 billion.
Added MK-4208, a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor recently granted BTD by the FDA for the treatment of certain adults with Philadelphia chromosome-positive chronic myeloid leukemia.
Notable recent news releases on the Company’s pipeline and portfolio are provided in the table that follows. Visit the News Releases section of the Company’s website to read the releases.*

Oncology

FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With WELIREG, for Adjuvant Treatment of Certain Patients With ccRCC; Based on Results From Phase 3 LITESPARK-022 Trial

FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With Padcev, as Treatment Before and After Surgery for Adults With MIBC; Based on Results From Phase 3 KEYNOTE-B15 Trial, Combined With Previous Approvals Based on Phase 3 KEYNOTE-905 Trial

FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With Trodelvy, as First-Line Treatment of PD-L1+ Advanced TNBC; Based on Results From Phase 3 KEYNOTE-D19/ASCENT-04 Trial

European Commission Approved KEYTRUDA Plus Padcev as First PD-1 Inhibitor Plus ADC Regimen for Adults With Cisplatin-Ineligible Resectable MIBC; Based on Results From Phase 3 KEYNOTE-905 Trial

FDA Granted BTD for Calderasib (MK-1084), an Investigational KRAS G12C Inhibitor, for Certain Patients With Newly Diagnosed Metastatic KRAS G12C-Mutant NSCLC

The Company Announced TroFuse-005 Trial Evaluating Sac-TMT Met Primary Endpoints of OS and PFS in Certain Patients With Advanced or Recurrent Endometrial Cancer

The Company and Moderna Presented 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection at ASCO (Free ASCO Whitepaper) 2026

KEYTRUDA as Monotherapy Significantly Improved PFS in Certain Patients With Advanced or Recurrent Endometrial Cancer With Mismatch Repair Deficient Tumors Compared to Chemotherapy; Results From Phase 3 KEYNOTE-C93 Trial

The Company Highlighted New Long-Term Data and Advancements Across Broad Oncology Portfolio and Pipeline Research at ASCO (Free ASCO Whitepaper) 2026

The Company Completed Acquisition of Terns

Vaccines and
Infectious Diseases

The Company, in Collaboration With Gilead, Announced That the Once-Weekly Investigational Oral HIV Treatment Regimen of Islatravir and Lenacapavir (ISL/LEN) Maintained Virological Suppression in People With HIV Who Switched Antiretroviral Therapy

The Company Presented New Data on Daily, Weekly and Monthly Options Across its HIV Treatment and Prevention Pipeline at AIDS 2026

The Company Announced Initial Access Plans for Alimatravir (MK-8527), Its Investigational Once-Monthly Oral Pre-Exposure Prophylaxis in Phase 3 Development; Multi-Faceted Strategy Aims To Enable Rapid, Broad and Sustainable Access to Alimatravir, if Approved, in Low- And Middle-Income Countries

The Company Announced New Agreement With AIDS Drug Assistance Program Crisis Task Force To Improve Access and Care for People Living With HIV

FDA Approved an Additional Indication for CAPVAXIVE in Children and Adolescents Aged 2 Through 17 at Increased Risk for Pneumococcal Disease; Based on Results From Phase 3 STRIDE-13 Trial

Cardiometabolic and Respiratory

FDA Approved LIPFENDRA, the First and Only Once-Daily Oral PCSK9 Inhibitor To Reduce LDL-C in Adults With Hypercholesterolemia; Based on Results From CORALreef Lipids and CORALreef HeFH Trials

Immunology

Tulisokibart Met Primary and Key Secondary Endpoints in the Phase 3 ATLAS-UC Induction-only Study in Patients With Moderately to Severely Active UC

Animal Health

The Company’s Animal Health Business Completed Acquisition of TARGAN, Broadening Its Commercial Poultry Portfolio Through TARGAN’s Innovative High-Speed Biodevice Technology

*References in the above news release titles have been modified for the purpose of this announcement.

Upcoming Investor Event
The Company will hold an Oncology Investor Event to coincide with the European Society for Medical Oncology Congress 2026 on Monday, Oct. 26, 2026, at 6 p.m. CET / 1 p.m. EDT, during which senior management will provide an update on the Company’s oncology strategy and program. The event will take place in Madrid, Spain, and will be accessible via live audio webcast at this weblink.

Full-Year 2026 Financial Outlook
The following table summarizes the Company’s full-year financial outlook.

Full Year 2026

Updated

Prior

Sales*

$66.3 billion to $67.3 billion

$65.8 billion to $67.0 billion

Non-GAAP Gross margin3

Approximately 81%

Approximately 82%

Non-GAAP Operating expenses3**

$42.0 billion to $42.7 billion

$36.0 billion to $36.8 billion

Non-GAAP Other (income) expense, net3

Approximately $1.4 billion expense

Approximately $1.3 billion expense

Non-GAAP Effective income tax rate3

35.0% to 36.0%

23.5% to 24.5%

Non-GAAP EPS3***

$2.66 to $2.76

$5.04 to $5.16

Share count (assuming dilution)

Approximately 2.48 billion

Approximately 2.48 billion

*The Company does not have any non-GAAP adjustments to sales.

**Includes one-time R&D charges of $9.0 billion for the acquisition of Cidara Therapeutics, Inc. (Cidara) and $5.7 billion for the acquisition of Terns. Outlook does not assume any additional significant potential business development transactions.

***Includes one-time charges of $3.62 per share for the acquisition of Cidara and $2.31 per share for the acquisition of Terns.

The Company has not provided a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating expenses, non-GAAP other (income) expense, net, non-GAAP effective income tax rate and non-GAAP EPS to the most directly comparable GAAP measures, given it cannot predict with reasonable certainty the amounts necessary for such a reconciliation, including intangible asset impairment charges, legal settlements, and income and losses from investments in equity securities either owned directly or through ownership interests in investment funds, without unreasonable effort. These items are inherently difficult to forecast and could have a significant impact on the Company’s future GAAP results.

The Company is raising and narrowing the range for its full-year sales outlook and now anticipates full-year 2026 sales to be between $66.3 billion and $67.3 billion, including a positive impact from foreign exchange of approximately 1% at mid-July 2026 exchange rates.

The Company now expects the full-year non-GAAP effective income tax rate to be between 35.0% and 36.0%, including the impact of the non-tax deductible one-time charges for the acquisitions of Cidara and Terns.

The Company now expects full-year 2026 non-GAAP EPS to be between $2.66 and $2.76, including a positive impact from foreign exchange of approximately $0.15 per share at mid-July 2026 exchange rates. This range includes one-time charges of $9.0 billion, or $3.62 per share, related to the acquisition of Cidara and $5.7 billion, or $2.31 per share, related to the acquisition of Terns. This range also includes costs of approximately $0.12 per share to finance the Terns acquisition and advance MK-4208. The charges related to Terns were not previously included in the outlook. In 2025, non-GAAP EPS of $8.98 was negatively impacted by one-time charges of $0.20 per share in the aggregate related to certain business development transactions.

Consistent with past practice, the financial outlook does not assume additional significant potential business development transactions.

Earnings Conference Call
Investors, journalists and the general public may access a live audio webcast of the call on Tuesday, Aug. 4, at 9 a.m. EDT via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures and slides highlighting the results, will be available on the Company’s website.

All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590.

(Press release, Merck & Co, AUG 4, 2026, View Source [SID1234669662])

On August 4, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage biotechnology company, reported financial and operational results for the second quarter ended June 30, 2026. Net product revenue reached $50.7 million, representing 92% year-over-year growth and 15% sequential growth from the first quarter of 2026. The Company also advanced multiple regulatory and clinical programs across its immunotherapy pipeline while achieving its eighth consecutive quarter of sequential net product revenue growth since ANKTIVA’s commercial launch.

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For the first-half of 2026, net product revenue totaled $94.8 million, up 121% compared with the first-half of 2025, and building on full-year 2025 net product revenue of $113.0 million. As of June 30, 2026, the Company had $357.4 million in cash and cash equivalents, and marketable securities.

Beyond its commercial momentum, ImmunityBio continued to advance a broad clinical pipeline spanning bladder cancer, non-small cell lung cancer, and hematologic malignancies. ANKTIVA is now approved or authorized in five regulatory jurisdictions, expanding its global footprint to 34 countries, while multiple ongoing clinical and regulatory programs continue to support the Company’s long-term growth strategy.

"Our record quarterly net product revenue of $50.7 million and eighth consecutive quarter of sequential growth reflect continued physician adoption of ANKTIVA and disciplined commercial execution," said Richard Adcock, President and CEO of ImmunityBio. "At the same time, we continue to invest in expanding ANKTIVA’s global commercial footprint while advancing a focused late-stage clinical pipeline that we believe will create additional opportunities across multiple oncology indications. With $357.4 million in cash and cash equivalents, and marketable securities, we are well-positioned to support both our commercial and clinical priorities."

"The continued adoption of ANKTIVA in clinical practice reinforces the potential of our IL-15 receptor agonist platform to activate the body’s natural killer and T cells to fight cancer," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "As we continue generating clinical evidence across multiple tumor types, including bladder cancer, lung cancer, and hematologic malignancies, we remain focused on expanding the potential applications of this platform to address additional areas of significant unmet medical need."

Quarterly Financial Highlights

Cash and Marketable Securities Position

As of June 30, 2026, the Company had consolidated cash and cash equivalents, and marketable securities of $357.4 million.

Second Quarter 2026 Financial Summary

Product Revenue, Net

Product revenue, net increased $24.3 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, due to increased net trade sales of ANKTIVA as a result of ongoing commercial activities.

Research and Development Expense

Research and development (R&D) expense increased $5.6 million to $60.8 million during the three months ended June 30, 2026, as compared to $55.2 million during the three months ended June 30, 2025, mainly due to increased personnel-related costs, clinical trial expenses, and external manufacturing and distribution costs.

Selling, General and Administrative Expense

Selling, general and administrative (SG&A) expense increased $9.5 million to $51.8 million during the three months ended June 30, 2026, as compared to $42.3 million during the three months ended June 30, 2025, mainly due to increased professional services expenses, personnel-related costs, and commercial-related expenses.

Other Expense, Net

Other expense, net increased $147.7 million to $168.7 million during the three months ended June 30, 2026, as compared to $21.0 million during the three months ended June 30, 2025, primarily due to non-cash changes in the fair value of the related-party convertible note, warrant liabilities, and other derivative liabilities mainly driven by a significant increase in our common stock price, and an increase in interest expense related to the revenue interest liability due to additional funding received in Q1 2026. These changes were partially offset by an increase in interest and investment income combined with a decrease in interest expense due to lower Term SOFR rates and a lower related-party convertible note balance after a partial loan conversion in Q1 2026.

Net Loss Attributable to ImmunityBio Common Stockholders (Net Loss)

Net loss attributable to ImmunityBio common stockholders was $230.4 million during the three months ended June 30, 2026, as compared to $92.6 million during the three months ended June 30, 2025. The increase in net loss was mainly driven by changes in the fair value of related-party convertible note, warrant and derivative liabilities due to an increase in our common stock price during the quarter, higher interest expense related to the revenue interest liability, and higher R&D and SG&A expenses described above, which were partially offset by higher product revenue.

Adjusted Net Loss Attributable to ImmunityBio Common Stockholders (Adjusted Net Loss)

Adjusted net loss attributable to ImmunityBio common stockholders decreased $8.9 million to $81.0 million during the three months ended June 30, 2026, as compared to $89.9 million during the three months ended June 30, 2025. Adjusted net loss is a non-GAAP financial measure that excludes the impact of certain items, as shown in the non-GAAP reconciliation table below.

First-Half 2026 Financial Summary

Product Revenue, Net

Product revenue, net increased $51.9 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, due to increased net trade sales of ANKTIVA as a result of ongoing commercial activities.

Research and Development Expense

R&D expense increased $25.3 million to $128.8 million during the six months ended June 30, 2026, as compared to $103.5 million during the six months ended June 30, 2025, mainly due to increased clinical trial expenses, external manufacturing costs, personnel-related costs, and distribution costs.

Selling, General and Administrative Expense

SG&A expense increased $22.6 million to $97.6 million during the six months ended June 30, 2026, as compared to $75.0 million during the six months ended June 30, 2025, mainly due to increased professional services expenses, personnel-related costs, and commercial-related expenses.

Other Expense, Net

Other expense, net increased $645.2 million to $731.7 million during the six months ended June 30, 2026, as compared to $86.5 million during the six months ended June 30, 2025, primarily due to non-cash changes in the fair value of warrant liabilities, the related-party convertible note, and other derivative liabilities mainly driven by a significant increase in our common stock price during Q2 2026, a one-time write-off of a convertible note receivable in Q1 2026, and an increase in interest expense related to the revenue interest liability due to additional funding received in Q1 2026. These changes were partially offset by an increase in interest and investment income combined with a decrease in interest expense due to lower Term SOFR rates and a lower related-party convertible note balance after a partial loan conversion in Q1 2026.

Net Loss Attributable to ImmunityBio Common Stockholders (Net Loss)

Net loss attributable to ImmunityBio common stockholders was $863.2 million during the six months ended June 30, 2026, compared to $222.2 million during the six months ended June 30, 2025. The increase in net loss was mainly driven by changes in fair value of warrant and derivative liabilities, and a related-party convertible note due to an increase in our common stock price during the period, higher interest expense related to the revenue interest liability, higher other expense, and higher R&D and SG&A expenses described above, which were partially offset by higher product revenue.

Adjusted Net Loss Attributable to ImmunityBio Common Stockholders (Adjusted Net Loss)

Adjusted net loss attributable to ImmunityBio common stockholders decreased $5.3 million to $167.3 million during the six months ended June 30, 2026, as compared to $172.6 million during the six months ended June 30, 2025. Adjusted net loss is a non-GAAP financial measure that excludes the impact of certain items, as shown in the non-GAAP reconciliation table below.

(Press release, ImmunityBio, AUG 4, 2026, View Source [SID1234669661])

On August 4, 2026 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), the global leader in relapsed/refractory AL Amyloidosis, reported that it will participate and host institutional investor meetings at the Morgan Stanley 24th Annual Global Healthcare Conference being held September 14-16, 2026 in New York, NY.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The Company will be available for one-on-one meetings during the conference. Interested investors should contact their Morgan Stanley representative to request meetings. A link to access the replay, when available, will be posted to the Immix website on the Presentation & Events page under the Investors section.

(Press release, Immix Biopharma, AUG 4, 2026, View Source [SID1234669660])

On August 4, 2026 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery, development and commercialization of targeted therapeutics, reported financial results for the second quarter ended June 30, 2026, and provided a business update.

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"This quarter marked another successful step forward in our mission to deliver new, potentially best-in-class precision therapies for people with cancer. We presented the positive topline results at ASCO (Free ASCO Whitepaper) from our registrational Phase 2/3 OptimUM-02 trial in HLA*A2:01-negative metastatic uveal melanoma while continuing to advance our NDA submission and pre-commercial activities to support a possible commercial launch. Additionally, our clinical pipeline is poised to deliver several key updates throughout the remainder of 2026, including updated data from IDE849, our DLL3 TOP1 ADC, in SCLC and NEC and clinical progress in MTAP-deleted cancers with IDE892, our PRMT5 inhibitor, as both a monotherapy and in combination with IDE397, our proprietary MAT2A inhibitor, and RG6505, Roche’s Phase 1 pan-RAS inhibitor in NSCLC and PDAC, respectively. With over $1.2 billion in cash following our successful financing in June, IDEAYA is well-positioned to continue advancing our precision medicine pipeline through multiple key data updates," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

Selected Pipeline Developments and Corporate Updates

Darovasertib for Uveal Melanoma

•
IDEAYA presented complete data from the primary analysis of OptimUM-02 in a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in Chicago, Illinois. Data were from a total of 313 patients with first line (1L) HLA*A2:01-negative mUM as of a January 23, 2026 cutoff date, randomized 2:1 to darovasertib in combination with crizotinib (the darovasertib combination) or an investigator’s choice of therapy (ICT) arm reflective of real-world clinical practice that included ipilimumab plus nivolumab (anti-CTLA-4/PD-1) or pembrolizumab (anti-PD-1). The primary endpoint is median progression-free survival (PFS) as assessed by blinded independent central review (BICR). Secondary endpoints include safety and investigator assessed PFS, overall response rate (ORR), disease control rate (DCR) and duration of response.
o
The trial met its primary endpoint, with patients receiving the darovasertib combination demonstrating a statistically significant improvement in median PFS of 6.9 months versus 3.1 months in the ICT arm by BICR (HR: 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001). A similar result was observed based on investigator assessment, with the combination leading to a median PFS of 6.7 months versus 2.7 months in the ICT arm (HR: 0.36; 95% CI: 0.26, 0.50, p-value: <0.0001).
o
Patients receiving the darovasertib combination also had clinically meaningful and statistically significant improvements across all key secondary endpoints.
o
Overall survival (OS) data was still immature as of the January 23, 2026 cutoff date; however, there was an early trend in OS improvement in the darovasertib combination arm relative to the ICT arm. IDEAYA plans to provide an update on the OS data as part of the pre-specified interim analysis expected in mid-2027.
o
Overall, the darovasertib combination was generally well-tolerated with a manageable safety profile, consistent with previous results and known side-effects of each agent.
•
IDEAYA has completed enrollment of approximately 100 HLA*A2:01-positive mUM patients in the single-arm, Phase 2 OptimUM-01 trial of the darovasertib combination. The company plans to present updated ORR, PFS and OS results from approximately 85 efficacy-evaluable HLA*A2:01-positive patients, including both first line and pre-treated patients, at the 2026 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress taking place in October in Madrid, Spain.
o
Data from OptimUM-01 will be included as part of IDEAYA’s NDA submission to the U.S. Food and Drug Administration (FDA) to support regulatory discussions that have the potential to expand the labeled indication of the darovasertib combination. IDEAYA also plans to publish data from OptimUM-01 for potential inclusion in the clinical practice guidelines to support the use of the combination in certain HLA*A2:01-positive mUM patients. Inclusion in the clinical practice guidelines, if achieved, is intended to provide healthcare professionals with an evidence-based rationale to consider use of darovasertib in appropriate patients and may support payer coverage for such patients.
•
Updated clinical data will also be presented at ESMO (Free ESMO Whitepaper) from the ongoing Phase 2 OptimUM-09 trial of neoadjuvant darovasertib. Based on ongoing patient recruitment considerations for the global Phase 3 OptimUM-10 trial IDEAYA is assessing optimal capital allocation across its portfolio, including accelerating its investment into other high-value programs, such as the DLL3 registrational trial and MTAP/KRAS combination studies. As part of this assessment, the Company is evaluating whether published data from the OptimUM-09 trial could provide a pathway for inclusion in clinical practice guidelines, supporting the use and payer coverage of darovasertib in the neoadjuvant setting of primary uveal melanoma.
o
If successful, this approach has the potential to accelerate patient access while reducing the investment required to support clinical utility in the neoadjuvant setting, enabling increased focus on other strategic development priorities.
•
Following the successful completion of a Type C meeting with the FDA earlier this year, IDEAYA and its partner, Les Laboratoires Servier (Servier), initiated a global Phase 3 registrational trial (OptimUM-11) to evaluate the darovasertib combination in the adjuvant setting of primary uveal melanoma. OptimUM-11 will enroll approximately 450 patients with increased risk of metastasis, irrespective of HLA status, randomized 1:1 to 12-months of treatment with the combination or observation. The primary endpoint of the trial is relapse-free survival.
ADC / DDR combinations

•
IDE849 (DLL3 TOP1 ADC): IDEAYA’s partner in China, Jiangsu Hengrui Pharmaceuticals (Hengrui), plans to provide a clinical data update from their ongoing Phase 1 trial in SCLC and NEC at ESMO (Free ESMO Whitepaper). The update will include updated ORR, PFS and safety data along with 12-month landmark OS data from approximately 100 patients enrolled in the trial. IDEAYA also plans to provide the first clinical data from its ongoing global Phase 1/2 trial of IDE849 in SCLC and NEC in the second half of 2026.
o
IDEAYA is having discussions with the FDA to align on the design of a Phase 3 registrational trial of IDE849 in refractory SCLC and/or NEC and plans to provide more detail on the proposed trial design with its data update in the second half of the year, with the goal of initiating the registrational trial by the end of 2026. Hengrui is also targeting to initiate a Phase 3 registrational trial for IDE849 in refractory SCLC in China by the end of 2026.
•
IDE161 (PARG): IDEAYA is also conducting a Phase 1 combination trial of IDE849 with IDE161, a potential first-in-class poly(ADP-ribose) glycohydrolase (PARG) inhibitor in patients with DLL3-upregulated solid tumors, including SCLC, NEC and melanoma.IDEAYA has previously shared preclinical data demonstrating the mechanism of action and potential synergy of IDE161 in combination with TOP1-payload based ADCs in driving enhanced anti-tumor activity.
•
IDE034 (B7H3/PTK7 bispecific TOP1 ADC): IDEAYA plans to provide initial clinical data from its ongoing Phase 1 dose escalation trial by the end of 2026 or early 2027, which is expected to include preliminary safety and efficacy data. IDE034 is a potentially first-in-class B7H3/PTK7 bispecific TOP1 ADC designed to be internalized only when its target antigens are co-expressed on the same tumor cell, which may enhance its selectivity and tolerability profile relative to monovalent antibody formats.
MTAP pathway

•
IDE892 (PRMT5): monotherapy expansion has been initiated in the Phase 1/2 clinical trial evaluating IDE892 in MTAP-deleted solid tumors, with a focus on non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). The expansion has been initiated at projected efficacious target human exposures where 24-hour target EC90 coverage has been achieved. The IDE892 maximum tolerated dose (MTD) has not yet been reached in the ongoing dose escalation.
•
IDE397 (MAT2A): a Phase 1/2 combination cohort was initiated to evaluate IDE892 with IDE397, IDEAYA’s proprietary MAT2A inhibitor, in MTAP-deleted cancers. Expansion is planned by year end 2026 or early 2027, with an initial clinical focus on MTAP-deleted NSCLC. Dual inhibition of MAT2A and PRMT5 has demonstrated durable and well-tolerated tumor regressions in preclinical MTAP-deleted tumor models, including in NSCLC.
•
In May, IDEAYA entered into a clinical trial collaboration with Roche to explore IDE892 in combination with RG6505, Roche’s proprietary Phase 1 pan-RAS inhibitor, in MTAP-deleted, RAS-mutant PDAC to target the genetic co-alterations of MTAP and KRAS in this indication. IDEAYA plans to begin a Phase 1 combination trial in the second half of 2026.
o
Upon joint IDEAYA and Roche approval, the collaboration may also evaluate a combination triplet with IDE892, RG6505, and IDE397, IDEAYA’s proprietary Phase 1/2 MAT2A inhibitor.
KAT6/7

•
IDE574 (KAT6/7): a Phase 1 dose escalation trial is underway in solid tumors including breast, prostate, colorectal and lung cancer. IDE574 is a selective, equipotent dual inhibitor of both KAT6 and KAT7 which spares other structurally similar paralogs, including KAT5 and KAT8, which are required for normal cell function. KAT6 and KAT7 are epigenetic modulators of cell identity and lineage commitment programs that are corrupted by oncogenic transformation.

Corporate

•
In June, IDEAYA successfully completed a public offering of 7,222,225 shares of common stock and pre-funded warrants to purchase 5,555,576 shares of common stock, inclusive of the underwriters’ full exercise of their option to purchase additional shares in the offering. Net proceeds from the offering were approximately $323.4 million, after deducting underwriting discounts, commissions and other expenses.
•
IDEAYA is targeting to host an MTAP/CDKN2A, KRAS, and Pancreatic Cancer R&D Day in the fourth quarter of 2026. Topics will include rational combination strategies to target the underlying tumor heterogeneity and adaptive plasticity in PDAC and other solid tumor indications. Additional agenda details and key participants will be provided at a later date.
•
As of June 30, 2026, IDEAYA had approximately $1.24 billion in cash, cash equivalents and marketable securities. IDEAYA’s cash runway guidance into 2030 is unchanged based on the current operating plan.

Financial Results for the Quarter Ended June 30, 2026
As of June 30, 2026, IDEAYA had cash, cash equivalents and marketable securities of approximately $1.24 billion, compared to $972.9 million as of March 31, 2026. The increase was primarily attributable to $323.4 million in net proceeds from the underwritten public offering and pre-funded warrants to purchase common stock and $33.1 million from the sale of common stock shares through IDEAYA’s at-the-market offering program, partially offset by net cash used in operations.

Collaboration revenue for the three months ended June 30, 2026, totaled $8.9 million, compared to $6.6 million for the three months ended March 31, 2026. Collaboration revenue was recognized for the performance obligations satisfied through June 30, 2026 related to the research and development services that are recognized over time under the Servier exclusive license agreement for darovasertib. As of June 30, 2026, the remaining balance for the research and development services performance obligations is $147.0 million related to the clinical development cost reimbursements anticipated under the license agreement that will be recognized as IDEAYA collaboration revenue over time as the research and development services are completed.

Research and development (R&D) expenses for the three months ended June 30, 2026 totaled $108.7 million, compared to $95.7 million for the three months ended March 31, 2026. The increase was primarily driven by higher clinical trial and personnel-related expenses to support IDEAYA’s programs.

General and administrative (G&A) expenses for the three months ended June 30, 2026 totaled $22.5 million, compared to $19.4 million for the three months ended March 31, 2026. The increase was primarily due to higher personnel-related expenses to support company growth and darovasertib commercial preparation activities.

The net loss for the three months ended June 30, 2026, was $112.5 million compared to the net loss of $98.5 million for the three months ended March 31, 2026. Total stock compensation expense for the three months ended June 30, 2026, was $16.7 million compared to $14.5 million for the three months ended March 31, 2026.

(Press release, Ideaya Biosciences, AUG 4, 2026, View Source [SID1234669659])

On August 4, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the second quarter 2026.

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"Gilead delivered a very strong second quarter, with 10% year-over-year revenue growth in our base business driven by our HIV portfolio, Trodelvy and Livdelzi. HIV sales grew 12%, reflecting continued strength in treatment and the rapid expansion of our PrEP business, supporting an increase in our base business revenue expectations for 2026," said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. "We also made significant clinical progress with three FDA approvals and three positive Phase 3 updates. We look forward to delivering on our many opportunities in the second half of the year including another two potential launches in oncology and HIV."

Second Quarter 2026 Financial Results

•Total second quarter 2026 revenues increased 10% to $7.8 billion compared to the same period in 2025, primarily driven by:
◦Higher sales of HIV products, Trodelvy (sacituzumab govitecan-hziy) and Livdelzi (seladelpar), partially offset by lower sales of Veklury (remdesivir) as well as Cell Therapy and chronic hepatitis C virus ("HCV") products; and
◦Higher royalty, contract and other revenues related to a previous sale of intellectual property.
•Diluted (loss) earnings per share ("EPS") was $(8.45) in the second quarter 2026 compared to $1.56 in the same period in 2025. The decrease was primarily driven by the $(9.08) per share impact of acquired in-process research and development ("IPR&D") expenses associated with our acquisitions of Arcellx, Inc. ("Arcellx"), Tubulis GmbH ("Tubulis") and Ouro Medicines, LLC ("Ouro Medicines"), net of the impact of our collaboration with Lakefront Biotherapeutics NV ("Lakefront") and the related taxes, as well as an IPR&D impairment related to assets previously acquired from Immunomedics, Inc. ("Immunomedics") and higher operating expenses. The decrease was partially offset by higher revenues, lower income tax expense, and higher net gains from equity securities.
•Non-GAAP diluted (loss) EPS was $(6.75) in the second quarter 2026 compared to $2.01 in the same period in 2025. The decrease was primarily driven by the $(9.08) per share impact of acquired IPR&D and tax expenses discussed above, as well as higher non-GAAP selling, general and administrative ("SG&A") expenses and non-GAAP income tax expense, partially offset by higher revenues.
•As of June 30, 2026, Gilead had $3.2 billion of cash, cash equivalents and marketable debt securities compared to $10.6 billion as of December 31, 2025. The decrease was primarily driven by year-to-date cash outflows of $11.3 billion related to acquisitions, $2.8 billion of debt repayments, $2.1 billion of dividend payments and $774 million of common stock repurchases, partially offset by $4.1 billion of net proceeds from debt financing and $6.1 billion of operating cash flow.
•During the second quarter 2026, Gilead generated $3.6 billion in operating cash flow.
•During the second quarter 2026, Gilead paid dividends of $1.0 billion and repurchased $355 million of common stock.

Second Quarter 2026 Product Sales
Total second quarter 2026 product sales increased 8% to $7.6 billion compared to the same period in 2025. Total second quarter 2026 product sales excluding Veklury increased 10% to $7.6 billion compared to the same period in 2025, primarily due to higher sales of HIV products, Trodelvy and Livdelzi, partially offset by lower sales of Cell Therapy and HCV products.
HIV product sales increased 12% to $5.7 billion in the second quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price and demand.
•Biktarvy (bictegravir 50mg/emtricitabine ("FTC") 200mg/tenofovir alafenamide ("TAF") 25mg) sales increased 7% to $3.8 billion in the second quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price, favorable inventory dynamics and higher demand.
•Descovy (FTC 200mg/TAF 25mg) sales increased 48% to $967 million in the second quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price and demand.
The Liver Disease portfolio sales increased 10% to $877 million in the second quarter 2026 compared to the same period in 2025, primarily reflecting higher demand for Livdelzi, as well as chronic hepatitis B virus ("HBV") products and Hepcludex (bulevirtide-gmod), partially offset by lower sales for HCV products.
Veklury sales decreased 81% to $23 million in the second quarter 2026 compared to the same period in 2025, primarily driven by lower rates of COVID-19-related hospitalizations.
Cell Therapy product sales decreased 14% to $417 million in the second quarter 2026 compared to the same period in 2025, reflecting ongoing competitive headwinds.
•Yescarta (axicabtagene ciloleucel) sales decreased 12% to $346 million in the second quarter 2026 compared to the same period in 2025, primarily driven by in- and out-of-class competition.
•Tecartus (brexucabtagene autoleucel) sales decreased 24% to $70 million in the second quarter 2026 compared to the same period in 2025, primarily driven by in-class competition.
Trodelvy (sacituzumab govitecan-hziy) sales increased 26% to $457 million in the second quarter 2026 compared to the same period in 2025, primarily driven by higher demand.
Second Quarter 2026 Product Gross Margin, Operating Expenses and Effective Tax Rate
•Product gross margin remained relatively flat at 79.3% in the second quarter 2026 compared to 78.7% in the same period in 2025. Non-GAAP product gross margin also remained flat at 86.9% in the second quarter 2026 compared to the same period in 2025.
•Research and development ("R&D") expenses were $1.8 billion in the second quarter 2026 compared to $1.5 billion in the same period in 2025, primarily due to integration costs and other acquisition-related expenses, partially offset by lower oncology clinical study activity. Non-GAAP R&D expenses were $1.4 billion in the second quarter 2026 compared to $1.5 billion in the same period in 2025, primarily driven by lower oncology clinical study activity.
•Acquired IPR&D expenses were $11.2 billion in the second quarter 2026, primarily related to $7.0 billion for the Arcellx acquisition, $3.1 billion for the Tubulis acquisition and $1.0 billion for the Ouro Medicines acquisition, net of the impact of the Lakefront collaboration.
•SG&A expenses were $1.9 billion in the second quarter 2026 compared to $1.4 billion in the same period in 2025, primarily driven by integration costs related to the acquisitions and higher HIV promotional activities. Non-GAAP SG&A expenses were $1.5 billion in the second quarter 2026 compared to $1.4 billion in the same period in 2025, primarily due to higher HIV promotional activities.

•The effective tax rate ("ETR") was (2.4)% in the second quarter 2026 compared to 19.3% in the same period in 2025. The non-GAAP ETR was (11.4)% in the second quarter 2026 compared to 18.8% in the same period in 2025. These changes primarily reflect the non-deductible acquired IPR&D expenses related to our acquisitions of Arcellx, Tubulis, and Ouro Medicines.
Guidance and Outlook
For the full year 2026, Gilead now expects:
(in millions, except per share amounts) August 4, 2026 Guidance
Low End High End Comparison to May 7, 2026 Guidance
Product sales $ 30,100 $ 30,400
Previously $30,000 to $30,400
Product sales excluding Veklury $ 29,800 $ 30,100
Previously $29,400 to $29,800
Veklury
~ $300
Previously ~ $600
Diluted loss per share $ (3.75) $ (3.40)
Previously $(3.25) to $(2.85)
Non-GAAP diluted loss per share $ (0.65) $ (0.30)
Previously $(1.05) to $(0.65)

Our full year 2026 GAAP and non-GAAP diluted loss per share guidance includes the impact of approximately $9.08 due to acquired IPR&D charges of $11.1 billion related to the Arcellx, Tubulis and Ouro Medicines transactions, net of the impact of the Lakefront collaboration and related taxes.
Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2026 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below.
Key Updates Since Our Last Quarterly Release
Virology
•Announced U.S. Food and Drug Administration ("FDA") accepted a supplemental New Drug Application submission for Yeztugo (lenacapavir) 300-mg tablets as a potential once-weekly oral formulation for HIV pre-exposure prophylaxis ("PrEP"), with a Prescription Drug User Fee Act target action date of February 2, 2027.
•Announced positive Phase 3 results from the ISLEND-1 and ISLEND-2 trials, in partnership with Merck, evaluating an investigational long-acting oral treatment regimen of islatravir 2 mg and lenacapavir 300 mg in adults with HIV who are virologically suppressed and switched from Biktarvy (ISLEND-1) or standard of care antiretroviral regimens (ISLEND-2) to the once-weekly combination.
•Received FDA accelerated approval for Hepcludex for the treatment of chronic hepatitis delta virus ("HDV") infection in adults without cirrhosis or with compensated cirrhosis, which is now the first and only FDA-approved treatment for HDV in the U.S.
•Announced a donation of 2,000 vials of remdesivir to the Republic of Uganda to support response efforts to the current outbreak of Ebola Bundibugyo virus disease ("BVD"). Remdesivir is not approved for the treatment of Ebola virus disease, including BVD, anywhere globally, and the safety and efficacy of this use is not known.
Oncology
•Received FDA approval of Trodelvy for the first-line ("1L") treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer ("mTNBC") as either a single agent for patients who are not candidates for PD-1/PD-L1 inhibitor-based therapy or in combination with Keytruda (pembrolizumab) or Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) for patients whose tumors express PD-L1 (CPS ≥10).

•Announced European Commission marketing authorization for Trodelvy as a monotherapy for the treatment of adult patients with unresectable locally advanced or mTNBC who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1/PD-L1 inhibitor therapy.
•Received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Trodelvy in combination with Keytruda (pembrolizumab) for the treatment of adult patients with unresectable locally advanced or mTNBC who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 (CPS≥10).
•Announced the discontinuation of the Phase 3 EVOKE-03 study, in partnership with Merck, evaluating Trodelvy in combination with Keytruda for the investigational treatment of 1L metastatic non-small cell lung cancer with high PD-L1 expression (TPS ≥50%). The decision was based on the recommendation of the external Data Monitoring Committee, following review of data from a pre-specified final analysis of progression-free survival and interim analysis of overall survival.
•Presented new analyses at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting from the Phase 3 ASCENT-03 and ASCENT-04 studies evaluating Trodelvy with or without Keytruda in 1L mTNBC, as well as new data on investigational anitocabtagene-autoleucel ("anito-cel") clinical trial manufacturing experience in patients with newly diagnosed or relapsed/refractory multiple myeloma.
•Presented updated Phase 1 results for KITE-753, an investigational bicistronic autologous CD19/CD20 CAR T-cell therapy for relapsed or refractory B-cell lymphoma at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) meeting.
•Completed the acquisition of Tubulis for $3.15 billion in upfront consideration. This acquisition brings Gilead next-generation antibody-drug conjugate ("ADC") assets, including GS-8824, a NaPi2b-directed topoisomerase-I inhibitor ADC, and a platform to develop novel ADCs.
Inflammation
•Completed the acquisition of Ouro Medicines for $1.675 billion in upfront consideration, which brings Gilead gamgertamig, an investigational clinical stage BCMAxCD3 T cell engager for autoimmune diseases. The acquisition was completed in collaboration with Lakefront, which equally shared the upfront payment and will equally share contingent milestone payments, subject to customary adjustments.
•Announced positive results from the Phase 3 IDEAL study, supporting the potential of Livdelzi to help people living with primary biliary cholangitis ("PBC") with elevated alkaline phosphatase ("ALP") levels (between 1.0 and 1.67xULN) whose disease remains inadequately controlled despite treatment with ursodeoxycholic acid ("UDCA"), or who are intolerant to UDCA.
•Presented data from the open-label Phase 3 ASSURE study at the 2026 European Association for the Study of the Liver Congress evaluating the long-term safety and tolerability profile of Livdelzi in people living with PBC with elevated ALP levels (between 1.0 and 1.67xULN) whose disease remains inadequately controlled despite treatment with UDCA, or who are intolerant to UDCA.
Corporate
•Issued $3.0 billion aggregate principal amount of senior unsecured notes and borrowed $1.1 billion aggregate principal amount under a one-year term loan facility.
•Announced a renewed 5-year collaboration with the World Health Organization to commit funding, strategic support and AmBisome donations toward eliminating visceral leishmaniasis.
•The Board declared a quarterly dividend of $0.82 per share of common stock for the third quarter of 2026. The dividend is payable on September 29, 2026, to stockholders of record at the close of business on September 15, 2026. Future dividends will be subject to Board approval.
Certain amounts and percentages in this press release may not sum or recalculate due to rounding.

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

(Press release, Gilead Sciences, AUG 4, 2026, View Source [SID1234669658])