On February 10, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the fourth quarter and full year 2025.

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"Our fourth quarter and full-year results close out a very strong year for Gilead overall, including the successful U.S. launch of Yeztugo, the world’s first twice-yearly HIV prevention therapy, and continued growth for Biktarvy and Descovy," said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. "In 2026, our potential new launches include two cancer therapies and an additional HIV treatment option, and we look forward to building on the launches of Yeztugo and Livdelzi for liver disease. As we continue to increase our positive impact on healthcare, Gilead is well positioned for continued growth in 2026 and beyond."

Fourth Quarter 2025 Financial Results

•Total fourth quarter 2025 revenues increased 5% to $7.9 billion compared to the same period in 2024, primarily driven by higher sales of HIV and Liver Disease products, partially offset by lower sales of Veklury (remdesivir).
•Diluted earnings per share ("EPS") was $1.74 in the fourth quarter 2025 compared to $1.42 in the same period in 2024. The increase was primarily driven by higher income tax benefits, net unrealized gains from equity securities and higher product sales, as well as lower selling, general and administrative ("SG&A") expenses. The increase was partially offset by higher acquired in-process research and development ("IPR&D") expenses and an IPR&D impairment charge related to assets acquired as part of the MYR GmbH ("MYR") acquisition.

•Non-GAAP diluted EPS of $1.86 in the fourth quarter 2025 compared to $1.90 in the same period in 2024. The decrease was primarily driven by higher acquired IPR&D expenses, partially offset by higher product sales and lower SG&A expenses.
•As of December 31, 2025, Gilead had $10.6 billion of cash, cash equivalents and marketable debt securities compared to $10.0 billion as of December 31, 2024.
•During the fourth quarter 2025, Gilead generated $3.3 billion in operating cash flow.
•During the fourth quarter 2025, Gilead paid dividends of $1.0 billion and repurchased $230 million of common stock.
Fourth Quarter 2025 Product Sales
Total fourth quarter 2025 product sales increased 5% to $7.9 billion compared to the same period in 2024. Total fourth quarter 2025 product sales excluding Veklury increased 7% to $7.7 billion compared to the same period in 2024, primarily due to higher sales of HIV and Liver Disease products.
HIV product sales increased 6% to $5.8 billion in the fourth quarter 2025 compared to the same period in 2024, primarily driven by higher demand for HIV prevention and treatment.
•Biktarvy (bictegravir 50mg/emtricitabine ("FTC") 200mg/tenofovir alafenamide ("TAF") 25mg) sales increased 5% to $4.0 billion in the fourth quarter 2025 compared to the same period in 2024, primarily driven by higher demand and favorable inventory dynamics, partially offset by lower average realized price.

•Descovy (FTC 200mg/TAF 25mg) sales increased 33% to $819 million in the fourth quarter 2025 compared to the same period in 2024, primarily driven by higher average realized price and higher demand for HIV prevention.
The Liver Disease portfolio sales increased 17% to $844 million in the fourth quarter 2025 compared to the same period in 2024, primarily driven by higher demand for Livdelzi (seladelpar).
Veklury sales decreased 37% to $212 million in the fourth quarter 2025 compared to the same period in 2024, primarily driven by lower rates of COVID-19-related hospitalizations.
Cell Therapy product sales decreased 6% to $458 million in the fourth quarter 2025 compared to the same period in 2024, reflecting ongoing competitive headwinds.
•Yescarta (axicabtagene ciloleucel) sales decreased 6% to $368 million in the fourth quarter 2025 compared to the same period in 2024, primarily driven by in- and out-of-class competition.
•Tecartus (brexucabtagene autoleucel) sales decreased 9% to $90 million in the fourth quarter 2025 compared to the same period in 2024, primarily driven by in-class competition.
Trodelvy (sacituzumab govitecan-hziy) sales increased 8% to $384 million in the fourth quarter 2025 compared to the same period in 2024, primarily driven by higher demand in breast cancer treatment.
Fourth Quarter 2025 Product Gross Margin, Operating Expenses and Effective Tax Rate
•Product gross margin remained relatively flat at 79.5% in the fourth quarter 2025 compared to 79.0% in the same period in 2024. Non-GAAP product gross margin was 86.8% in the fourth quarter 2025 compared to 86.7% in the same period in 2024.
•Research and development ("R&D") expenses and non-GAAP R&D expenses were $1.6 billion in the fourth quarter 2025 and remained relatively flat compared to the same period in 2024.
•Acquired IPR&D expenses were $539 million in the fourth quarter 2025, primarily related to our acquisition of Interius BioTherapeutics, Inc. ("Interius") and ongoing collaboration with Shenzhen Pregene Biopharma Co., Ltd. ("Pregene").
•SG&A expenses were $1.8 billion in the fourth quarter 2025 compared to $1.9 billion in the same period in 2024, decreasing primarily due to lower expenses related to legal matters and corporate initiatives, partially offset by donations of equity securities made to the Gilead Foundation. Non-GAAP SG&A expenses were $1.7 billion in the fourth quarter 2025 compared to $1.9 billion in the same period in 2024, primarily due to lower expenses related to legal matters and corporate initiatives.
•The effective tax rate ("ETR") was (5.0)% in the fourth quarter 2025 compared to 17.8% in the same period in 2024, primarily driven by a tax benefit from a settlement with a tax authority related to a prior year legal entity restructuring and a tax benefit from the IPR&D impairment charge related to assets acquired as part of the MYR acquisition. The non-GAAP ETR was 20.5% in the fourth quarter 2025 compared to 19.2% in the same period in 2024.
Full Year 2025 Financial Results
•Total full year 2025 revenues increased 2% to $29.4 billion compared to 2024, broken down as follows:
◦Total full year 2025 product sales increased 1% to $28.9 billion compared to 2024, primarily driven by higher sales of HIV and Liver Disease products, partially offset by lower sales of Veklury.
◦Total full year 2025 royalty, contract and other revenues increased by approximately $383 million compared to 2024, primarily driven by revenue related to a previous sale of intellectual property not expected to reoccur.
•Diluted EPS was $6.78 in the full year 2025 compared to $0.38 in 2024. The increase was primarily driven by lower acquired IPR&D expenses, lower IPR&D impairments, higher net unrealized gains on equity investments, higher revenues and lower SG&A expenses, partially offset by higher tax expense.

•Non-GAAP diluted EPS was $8.15 in the full year 2025 compared to $4.62 in 2024. The increase was primarily driven by lower acquired IPR&D expenses, higher revenues, and lower SG&A expenses.
Full Year 2025 Product Sales
Total full year 2025 product sales increased 1% to $28.9 billion compared to 2024. Total full year 2025 product sales excluding Veklury increased 4% to $28.0 billion compared to 2024, primarily due to higher sales of HIV and Liver Disease products.
HIV product sales increased 6% to $20.8 billion in the full year 2025 compared to 2024, primarily driven by higher demand for HIV treatment and prevention.
•Biktarvy sales increased 7% to $14.3 billion in the full year 2025 compared to 2024, primarily driven by higher demand, partially offset by lower average realized price.
•Descovy sales increased 31% to $2.8 billion in the full year 2025 compared to 2024, primarily driven by higher demand and average realized price.
The Liver Disease portfolio sales increased 6% to $3.2 billion in the full year 2025 compared to 2024, primarily driven by higher demand for Livdelzi and products for chronic hepatitis B virus ("HBV") and chronic hepatitis delta virus ("HDV"), partially offset by lower average realized price in products for chronic hepatitis C virus ("HCV").
Veklury sales decreased 49% to $911 million in the full year 2025 compared to 2024, primarily driven by lower COVID-19-related hospitalizations.
Cell Therapy product sales decreased 7% to $1.8 billion in the full year 2025 compared to 2024, reflecting ongoing competitive headwinds.
•Yescarta sales decreased 5% to $1.5 billion in the full year 2025 compared to 2024, primarily driven by in- and out-of-class competition.
•Tecartus sales decreased 15% to $344 million in the full year 2025 compared to 2024, primarily driven by in-class competition.
Trodelvy sales increased 6% to $1.4 billion in the full year 2025 compared to 2024, primarily driven by higher demand in breast cancer treatment, partially offset by the indication withdrawal in bladder cancer treatment.
Full Year 2025 Product Gross Margin, Operating Expenses and Effective Tax Rate
•Product gross margin remained relatively flat at 78.4% in the full year 2025 compared to 78.2% in 2024. Non-GAAP product gross margin was 86.4% in the full year 2025 compared to 86.2% in 2024.
•R&D expenses were $5.8 billion in the full year 2025 compared to $5.9 billion in 2024, decreasing primarily due to lower acquisition-related integration expenses and restructuring costs, as well as lower study-related and clinical manufacturing expenses. Non-GAAP R&D expenses were $5.7 billion in the full year 2025, decreasing slightly compared to 2024 due to lower study-related and clinical manufacturing expenses.
•Acquired IPR&D expenses were $1.0 billion in the full year 2025, primarily related to the acquisition of Interius and collaborations with LEO Pharma A/S and Pregene.
•SG&A expenses were $5.8 billion in the full year 2025 compared to $6.1 billion in 2024, decreasing primarily due to lower corporate, legal, acquisition-related integration and restructuring expenses, partially offset by higher HIV promotional expenses and donations of equity securities made to the Gilead Foundation. Non-GAAP SG&A expenses were $5.6 billion in the full year 2025 compared to $5.9 billion in 2024, decreasing primarily due to lower expenses related to corporate initiatives and legal matters, partially offset by higher HIV promotional expenses.

•The ETR was 13.1% in the full year 2025 compared to 30.5% in 2024, primarily driven by the impact of the prior year non-deductible acquired IPR&D charge for the acquisition of CymaBay Therapeutics, Inc. ("CymaBay"), partially offset by the tax impact of the prior year higher IPR&D impairment charges. The non-GAAP ETR was 18.3% in the full year 2025 compared to 25.9% in 2024, primarily driven by the prior year non-deductible acquired IPR&D charge for the acquisition of CymaBay.
Guidance and Outlook
For the full year 2026, Gilead expects:
(in millions, except per share amounts)
February 10, 2026 Guidance
Low End High End
Product sales $ 29,600 $ 30,000
Product sales excluding Veklury $ 29,000 $ 29,400
Veklury $ 600 $ 600
Diluted EPS $ 6.75 $ 7.15
Non-GAAP diluted EPS $ 8.45 $ 8.85

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 positive topline Phase 3 results from the ARTISTRY-1 and ARTISTRY-2 trials, evaluating our investigational daily oral single-tablet regimen of bictegravir 75mg and lenacapavir 50mg ("BIC/LEN") for virologically suppressed adults with HIV. BIC/LEN met its primary endpoints demonstrating non-inferiority to baseline multi-tablet antiviral regimens (ARTISTRY-1) and Biktarvy (ARTISTRY-2).
•Exercised option to license investigational herpes simplex virus helicase-primase inhibitor programs ABI-1179 and ABI-5366 from Assembly Biosciences, Inc. ("Assembly").
•Announced the first delivery of lenacapavir for PrEP in sub-Saharan African countries Eswatini and Zambia through the U.S. President’s Emergency Plan for AIDS Relief.

Oncology

•Announced that the Phase 3 ASCENT-07 study evaluating the investigational use of Trodelvy versus chemotherapy in first-line post-endocrine HR+/HER2- metastatic breast cancer did not meet its primary endpoint of progression-free survival as assessed by Blinded Independent Central Review. Overall survival, a secondary endpoint, was not mature at the time of the primary analysis, however, a favorable early trend compared to chemotherapy was observed in the Trodelvy arm. In addition, no new safety signals were identified in this patient population. The results from this study were presented at the 2025 San Antonio Breast Cancer Symposium.

•Announced the discontinuation of the Phase 3 STAR-221 study, in partnership with Arcus Biosciences, Inc. ("Arcus"), evaluating the anti-TIGIT antibody domvanalimab ("dom") plus zimberelimab ("zim") and chemotherapy in first-line HER2- advanced gastric and esophageal cancers. The decision was based on the recommendation of the Independent Data Monitoring Committee, following review of data from a pre-specified interim analysis. Additionally, Gilead and Arcus will discontinue the Phase 2 EDGE-Gastric study evaluating dom and zim regimens in upper gastrointestinal cancers. Dom and zim are investigational products and are not approved anywhere globally.

Cell Therapy

•Announced a new label update for Yescarta that removes a limitation around Primary Central Nervous System Lymphoma, an ultra-rare cancer affecting a highly vulnerable patient population. Yescarta is the only CAR-T therapy in relapsed or refractory large B-cell lymphoma ("R/R LBCL") to have this limitation removed.
•Presented new positive data, with our partner Arcellx, Inc. ("Arcellx"), from the pivotal Phase 2 iMMagine-1 trial evaluating the investigational CAR T-cell therapy anitocabtagene autoleucel in 4L+ R/R multiple myeloma at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH").
•Presented initial Phase 1 data for KITE-753 and KITE-363, evaluating two investigational bicistronic CAR T-cell therapies in patients with R/R LBCL at ASH (Free ASH Whitepaper) 2025.
•Presented a new analysis of Yescarta from the Phase 3 ZUMA-7 and Phase 2 ALYCANTE study in patients with R/R LBCL at ASH (Free ASH Whitepaper) 2025. The data demonstrated consistent benefits of Yescarta among patients with R/R LBCL, including those ineligible for previous standard of care chemotherapy and stem cell transplant.
Inflammation
•Presented new long-term data from the Phase 3 ASSURE study for Livdelzi, which reinforce the safety and efficacy of Livdelzi for people living with primary biliary cholangitis over 3 years, including data on switching from obeticholic acid. The data were presented at the American Association for the Study of Liver Diseases meeting.
Corporate
•The Board declared a quarterly dividend of $0.82 per share of common stock for the first quarter of 2026. The dividend is payable on March 30, 2026, to stockholders of record at the close of business on March 13, 2026. Future dividends will be subject to Board approval.
•Appointed Keeley Cain Wettan as Executive Vice President, General Counsel, Legal and Compliance.
•Announced an agreement with the U.S. government to lower the cost of medicines for Americans, reinforcing a commitment to U.S.-based innovation, affordability and global health leadership.
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, FEB 10, 2026, View Source [SID1234662565])

On February 10, 2026 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that IP Australia, the Australian government agency responsible for administering Australia’s intellectual property rights system, has issued a Notice of Acceptance, on February 5, 2026, of the Genprex patent application claiming the use of Reqorsa Gene Therapy in combination with PD-L1 antibodies for the treatment of cancers. The subject claims have been successfully granted in other countries. Should the patent grant, it will strengthen Genprex’s intellectual property portfolio, providing crucial protection for the therapeutic combination currently being evaluated in the Acclaim-3 clinical trial.

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"The intent to grant a new patent by IP Australia for Reqorsa Gene Therapy in combination with PD-L1 antibodies is a pivotal development for Genprex, further bolstering the intellectual property surrounding our innovative therapeutic approach," said Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing at Genprex. "This patent specifically provides additional protection for the therapeutic combination currently being evaluated in our Acclaim-3 clinical trial, underscoring our commitment to advancing cancer treatment."

A granted patent will secure exclusivity for this drug combination in Australia, preventing potential competitors from manufacturing, using or selling it. Such exclusivity is vital for protecting the significant investments made in research and development, ensuring that Genprex can continue to pursue and commercialize its novel therapeutic approaches without immediate competitive infringement in this specific combination.

The grant of a patent will build upon Genprex’s existing intellectual property foundation, which includes granted patents for the use of REQORSA in combination with PD-L1 antibodies in the U.S. and Korea. Genprex is actively pursuing additional patent applications in key international markets, including Europe, Canada, Brazil, China and Israel. This comprehensive patent strategy is designed to safeguard the company’s innovations and maximize the potential of its pipeline assets.

In addition, the Company has also recently opened an additional clinical trial site for the Acclaim-3 clinical trial to include the University of Kentucky. The Company expects to add and open additional clinical trial sites for its Acclaim clinical trials in an effort to expand its reach to additional patients and expedite enrollment. These developments further underscore Genprex’s commitment to protecting and expeditiously advancing its clinical trials in lung cancer.

About Acclaim-3

Acclaim-3 is a Phase 1/2 clinical trial evaluating the combination of REQORSA and Genentech’s Tecentriq (atezolizumab) as maintenance therapy in patients with extensive stage small cell lung cancer (ES-SCLC) who are candidates for maintenance therapy after receiving Tecentriq and chemotherapy as standard of care initial treatment. In this study, patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced.

The Phase 2 expansion study follows the successful completion of the Phase 1 dose escalation portion of the study, which showed REQORSA was generally well tolerated. There were no dose limiting toxicities, and in Acclaim-3, the Phase 2 patients are receiving the same dose of REQORSA as patients in the Phase 2 portion of Acclaim-1.

The Phase 2 expansion portion is expected to enroll approximately 50 patients. The primary endpoint of the Phase 2 portion is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. Genprex’s team plans to conduct an interim analysis after the 25th patient enrolled and treated reaches 18 weeks of follow up. The Company expects to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the study in the first half of 2026 and expects the interim analysis in the second half of 2026. The Acclaim-3 clinical trial is supported by FDA Fast Track Designation and Orphan Drug Designation.

(Press release, Genprex, FEB 10, 2026, View Source [SID1234662564])

On February 10, 2026 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the fourth quarter and fiscal year of 2025, provided an update on progress toward achieving key corporate objectives, and outlined its commercial, clinical and pipeline development milestones.

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"Exelixis delivered strong results in 2025 and is well positioned for a breakout year in 2026," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "The cabozantinib franchise continued to grow with robust demand in renal cell carcinoma and neuroendocrine tumors driving a significant increase in net product revenues in 2025 compared to the prior year. Based on the early success in neuroendocrine tumors and with additional gastrointestinal cancer market opportunities ahead, we’ve expedited the full buildout of our GI sales team to accelerate cabozantinib’s growth and prepare for potential future indications for zanzalintinib. The team is highly motivated to build a second Exelixis oncology franchise with zanzalintinib and is working diligently to advance a first potential indication in metastatic colorectal cancer, following the recent acceptance of our New Drug Application by U.S. regulatory authorities."

Dr. Morrissey continued: "2026 is shaping up to be a milestone-rich year for Exelixis. In addition to the continued growth of the cabozantinib franchise and ongoing regulatory engagement for zanzalintinib, we anticipate key clinical readouts from the STELLAR-303 and -304 pivotal trials, planned trial initiations of STELLAR-316 and STELLAR-201 supporting the next wave of zanzalintinib’s pivotal development, and significant progress across our early-stage pipeline. As we execute on these priorities, we remain focused on advancing high-impact opportunities that have the potential to improve standards of care for patients with cancer, drive sustainable growth and build shareholder value."

Fourth Quarter and Fiscal Year 2025 Financial Results

Total revenues for the quarter and year ended December 31, 2025 were $598.7 million and $2,320.1 million, respectively, as compared to $566.8 million and $2,168.7 million for the comparable periods in 2024.

Total revenues for the quarter and year ended December 31, 2025 included net product revenues of $546.6 million and $2,122.8 million, respectively, as compared to $515.2 million and $1,809.4 million for the comparable periods in 2024. The increases in net product revenues, for both periods, were primarily due to an increase in sales volume.

Collaboration revenues, composed of license revenues and collaboration services revenues, were $52.1 million for the quarter ended December 31, 2025, as compared to $51.5 million for the comparable period in 2024. The increase in collaboration revenues, for the quarter, was primarily related to higher royalty revenues for the sales of cabozantinib outside the U.S. generated by Exelixis’ collaboration partner Ipsen Pharma SAS (Ipsen), partially offset by lower development cost reimbursements earned. Collaboration revenues were $197.3 million for the year ended December 31, 2025, as compared to $359.3 million for the comparable period in 2024. The decrease in collaboration revenues, for the year, was primarily related to lower milestone-related revenues recognized and lower development cost reimbursements earned, partially offset by higher royalty revenues for the sales of cabozantinib outside of the U.S. generated by Exelixis’ collaboration partner Ipsen.

Research and development expenses for the quarter and year ended December 31, 2025 were $213.2 million and $825.0 million, respectively, as compared to $249.0 million and $910.4 million for the comparable periods in 2024. The decreases in research and development expenses, for both periods, were primarily related to decreases in license and other collaboration costs, clinical trial costs, and manufacturing costs to support our development candidates, partially offset by an increase in consulting and outside services.

Selling, general and administrative expenses for the quarter ended December 31, 2025 were $123.0 million, as compared to $134.3 million for the comparable period in 2024. The decrease in selling, general and administrative expenses, for the quarter, was primarily related to decreases in corporate giving, stock-based compensation and personnel expenses. Selling, general and administrative expenses for the year ended December 31, 2025 were $518.7 million, as compared to $492.1 million for the comparable period in 2024. The increase in selling, general and administrative expenses, for the year, was primarily related to increases in marketing activities, stock-based compensation, and personnel expenses, partially offset by a decrease in corporate giving.

Provision for income taxes for the quarter and year ended December 31, 2025 was $8.2 million and $158.6 million, respectively, as compared to $44.9 million and $160.4 million for the comparable periods in 2024.

GAAP net income for the quarter ended December 31, 2025 was $244.5 million, or $0.92 per share, basic and $0.88 per share, diluted, as compared to GAAP net income of $139.9 million, or $0.49 per share, basic and $0.48 per share, diluted, for the comparable period in 2024. GAAP net income per share for the year ended December 31, 2025 was $782.6 million, or $2.88 per share, basic and $2.78 per share, diluted, as compared to GAAP net income of $521.3 million, or $1.80 per share, basic and $1.76 per share, diluted, for the comparable period in 2024.

Non-GAAP net income for the quarter ended December 31, 2025 was $259.5 million, or $0.97 per share, basic and $0.94 per share, diluted, as compared to non-GAAP net income of $160.3 million, or $0.56 per share, basic and $0.55 per share, diluted, for the comparable period in 2024. Non-GAAP net income for the year ended December 31, 2025 was $869.5 million, or $3.20 per share, basic and $3.08 per share, diluted, as compared to non-GAAP net income of $593.6 million, or $2.05 per share, basic and $2.00 per share, diluted, for the comparable period in 2024.

Non-GAAP Financial Measures

To supplement Exelixis’ financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis presents non-GAAP net income (and the related per share measures), which excludes from GAAP net income (and the related per share measures) stock-based compensation, adjusted for the related income tax effect for all periods presented.

Exelixis believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Exelixis believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Exelixis’ results from period to period, and to identify operating trends in Exelixis’ business. Exelixis has excluded stock-based compensation, adjusted for the related income tax effect, because it is a non-cash item that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. Exelixis also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.

These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Exelixis encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations, to more fully understand Exelixis’ business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

2026 Financial Guidance

Exelixis is maintaining the previously provided financial guidance for fiscal year 2026. Net product and total revenues guidance do not currently reflect any revenues resulting from a potential U.S. regulatory approval and commercial launch of zanzalintinib for the treatment of patients with previously treated metastatic colorectal cancer (CRC). The U.S. Food and Drug Administration (FDA) is currently reviewing Exelixis’ New Drug Application (NDA) for this proposed indication, when used in combination with atezolizumab (Tecentriq).

Total revenues

$2.525 billion – $2.625 billion

Net product revenues

$2.325 billion – $2.425 billion(1)

Cost of goods sold, % of net product revenues

3.5% – 4.5%

Research and development expenses

$875 million – $925 million(2)

Selling, general and administrative expenses

$575 million – $625 million(3)

Effective tax rate

21% – 23%

(1)

Exelixis’ 2026 net product revenues guidance range includes the impact of a U.S. wholesale acquisition cost increase of 3.0% for both CABOMETYX and COMETRIQ effective on January 1, 2026.

(2)

Includes $50.0 million of non-cash stock-based compensation expense.

(3)

Includes $75.0 million of non-cash stock-based compensation expense.

Cabozantinib Highlights

Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the U.S. were $546.6 million during the fourth quarter of 2025, with net product revenues of $544.7 million from CABOMETYX (cabozantinib) and $1.8 million from COMETRIQ (cabozantinib). For the year ended December 31, 2025, net product revenues generated by the cabozantinib franchise in the U.S. were $2,122.8 million, with net product revenues of $2,113.4 million from CABOMETYX and $9.4 million from COMETRIQ. In 2025, global cabozantinib franchise net product revenues generated by Exelixis and its collaboration partners, Ipsen and Takeda Pharmaceutical Company Limited, were $2.9 billion. Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter and year ended December 31, 2025, Exelixis earned $52.8 million and $179.2 million, respectively, in royalty revenues.

Presentation of Results from Subgroup Analysis of the CABINET Phase 3 Pivotal Trial Evaluating CABOMETYX in Advanced Lung and Thymic Neuroendocrine Tumors (NET) at the 2025 European Society for Medical Oncology Congress (ESMO 2025). In October 2025, results from a subgroup analysis of the CABINET trial evaluating CABOMETYX versus placebo in patients with previously treated advanced NET originating in the lungs or thymus were presented at ESMO (Free ESMO Whitepaper) 2025. These subgroup results demonstrated that CABOMETYX significantly reduced the risk of disease progression or death versus placebo in patients with lung or thymic NET. The safety profile of CABOMETYX observed in patients with lung or thymic NET was consistent with its known safety profile; no new safety signals were identified. In March 2025, the U.S. FDA approved CABOMETYX for two new NET indications, advanced pancreatic and extra-pancreatic NET (pNET and epNET), based on results from the CABINET study.

Zanzalintinib Highlights

FDA Acceptance of NDA for Zanzalintinib in Combination with Atezolizumab for Previously Treated Metastatic CRC. In February 2026, Exelixis announced that the FDA accepted its NDA for zanzalintinib as a treatment for patients with previously treated metastatic CRC, when used in combination with atezolizumab. The FDA assigned a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026. The NDA was based on positive results from the STELLAR-303 phase 3 pivotal trial, which met one of its dual primary endpoints, with the combination of zanzalintinib and atezolizumab demonstrating a statistically significant reduction in the risk of death versus regorafenib in the intention-to-treat (ITT) population at the final analysis. An overall survival (OS) benefit with the combination was consistently observed across pre-specified subgroups, including geographic region, RAS status, liver involvement and prior anti-VEGF therapy.

Collaboration Agreement with Natera for STELLAR-316 Phase 3 Pivotal Trial. In January 2026, Exelixis announced a collaboration with Natera, a global leader in cell-free DNA and precision medicine, for STELLAR-316, the planned, Exelixis-sponsored phase 3 pivotal trial. STELLAR-316 will evaluate zanzalintinib, with and without an immune checkpoint inhibitor, in patients with resected stage II/III CRC who, following definitive therapy, have tested positive for molecular residual disease (MRD+) and have no radiographic evidence of disease. The primary endpoint of STELLAR-316 is disease-free survival, with secondary endpoints including circulating tumor DNA clearance. Natera will provide its Signatera assay to identify MRD+ patients for trial enrollment. Exelixis expects to initiate STELLAR-316 in mid-2026.

Merck’s Initiation of LITESPARK-033 Phase 3 Pivotal Trial of Zanzalintinib in Combination with WELIREG (belzutifan) in First-line Advanced Renal Cell Carcinoma (RCC). In December 2025, Merck, known as MSD outside of the United States and Canada, initiated LITESPARK-033, the first of two planned Merck-sponsored pivotal trials of zanzalintinib and belzutifan in RCC under the companies’ clinical development collaboration. LITESPARK-033 is evaluating the combination of zanzalintinib and belzutifan versus cabozantinib in first-line advanced RCC following an immunotherapy administered in the adjuvant setting. Details of the second Merck-sponsored trial will be made available by Merck at a later date.

Detailed Results from STELLAR-303 Phase 3 Pivotal Trial Presented at ESMO (Free ESMO Whitepaper) 2025 and Published in The Lancet. In October 2025, Exelixis presented detailed results from STELLAR-303 at ESMO (Free ESMO Whitepaper) 2025; these detailed findings were simultaneously published in The Lancet. As previously announced in June, the study met one of its dual primary endpoints, OS in the ITT population, with the OS benefit of the zanzalintinib and atezolizumab combination consistently observed across pre-specified subgroups. Data pertaining to the other dual primary endpoint, OS in patients without liver metastases (non-liver metastases or NLM), were immature at the data cutoff. A prespecified interim analysis showed a trend in OS favoring the combination. The trial will proceed to the planned final analysis for this endpoint, which is expected in mid-2026, based on current event rates. The safety profiles of zanzalintinib in combination with atezolizumab and of regorafenib were generally consistent with what has been previously observed, and no new safety signals were identified.

Corporate Highlights

Stock Repurchase Program (SRP) Update. In the fourth quarter of 2025, Exelixis repurchased $264.5 million of the company’s stock, at an average price of $43.17 per share, and completed the $500 million SRP authorized in February 2025. Since Exelixis’ Board of Directors authorized the first SRP in March 2023, Exelixis has repurchased a total of $2.16 billion of the company’s common stock, retiring 76.7 million shares, at an average price of $28.14 per share, as of the end of fiscal year 2025. In October 2025, Exelixis’ Board of Directors authorized the repurchase of up to an additional $750 million of the company’s common stock before December 31, 2026. Exelixis began executing stock repurchases under the October 2025 SRP in the fourth quarter of 2025. Stock repurchases under this program may be made from time to time through a variety of methods, which may include open market purchases, in block trades, Rule 10b5-1 trading plans, accelerated share repurchase transactions, exchange transactions or any combination of such methods. The timing and amount of any stock repurchases under the SRP will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of our common stock and general market conditions. The program does not obligate Exelixis to acquire any amount of its common stock, and the SRP may be modified, suspended or discontinued at any time without prior notice.

Announcement of Key Priorities and Anticipated Milestones for 2026. In January 2026, Exelixis announced its key priorities and anticipated milestones for the year, including: anticipated results from the STELLAR-303 dual primary endpoint, OS in NLM patients, in mid-2026, based on current event rates; anticipated topline results from STELLAR-304, the phase 3 pivotal trial evaluating zanzalintinib in combination with nivolumab versus sunitinib in previously untreated patients with advanced non-clear cell RCC, in mid-2026, based on current event rates; the planned initiations of STELLAR-316 and of STELLAR-201, a potential label-enabling trial evaluating zanzalintinib in recurrent meningioma, a disease with no currently approved systemic therapies, in mid-2026; and the potential filing of two Investigational New Drug applications—one for XB773, an antibody-drug conjugate, and one for a development candidate from our somatostatin receptor subtype 2 agonist program. The company presented details of its 2026 priorities and milestones at the J.P. Morgan 2026 Healthcare Conference.

Presentation of Exelixis’ Strategy to Advance Future Oncology Franchises at the Company’s 2025 R&D Day: Building Next-generation Oncology Franchises. In December 2025, Exelixis hosted its virtual 2025 R&D Day, themed Building Next-generation Oncology Franchises. During the event, company leadership and expert guests outlined Exelixis’ R&D strategy and multi-franchise approach, highlighted key progress and upcoming milestones for the zanzalintinib development program and provided an overview of the rapidly advancing pipeline. The event underscored Exelixis’ continued commitment to expanding treatment options for patients with cancer while delivering sustainable, long-term value for shareholders. A replay of the event webcast can be accessed here in the Investor & News section of www.exelixis.com.

Basis of Presentation

Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31. For convenience, references in this press release as of and for the fiscal periods ended January 2, 2026 and January 3, 2025, are indicated as being as of and for the periods ended December 31, 2025 and 2024, respectively.

Conference Call and Webcast

Exelixis management will discuss the company’s financial results for the fourth quarter and fiscal year 2025 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Tuesday, February 10, 2026.

To access the conference call, please register using this link. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. A webcast replay of the conference call will also be archived on www.exelixis.com for one year.

(Press release, Exelixis, FEB 10, 2026, View Source [SID1234662563])

On February 10, 2026 Defence Therapeutics Inc. ("Defence" or the "Company"), a publicly traded biotechnology and precision intracellular drug-delivery company, reported on its Scientific Advisory Board ("SAB") meeting held on January 30, 2026, focused on advancing the strategic positioning of Accum for antibody–drug conjugate ("ADC") applications.

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The discussion brought together complementary expertise spanning ADC chemistry and development, experimental design and translational science, and value creation and partnering strategy, enabling an in-depth and highly constructive exchange on Accum’s role in improving intracellular delivery of ADC payloads. The conversation focused on identifying the most critical scientific questions to address, refining development priorities, and aligning data generation with the expectations of future clinical and pharmaceutical partners.

"This was an exceptionally valuable discussion that helped us sharpen both our scientific focus and our strategic direction," said Maxime Parisotto, PhD, Chief Scientific Officer of Defence Therapeutics. "The insights shared by our advisors are directly informing how we design our next studies, ensuring that we generate the data that matter most to advance Accum toward the clinic and position the platform for meaningful partnerships."

The discussion benefited from the complementary expertise of Rob Leanna, PhD, whose experience in ADC development, drug–linker chemistry, and clinical advancement was shaped through his long tenure at AbbVie; Danny Chui, PhD, who brought deep insight into ADC design and translational science informed by his significant work at Zymeworks, Abdera Therapeutics, and Kairos Therapeutics; and Brendan Hussey, PhD, who contributed a value-creation and partnering perspective grounded in clinical development, strategy, and capital formation. Together, their input is guiding the next phase of Accum development as the platform advances toward clinical translation and strategic partnerships.

As a result of this multidisciplinary dialogue, Defence Therapeutics is refining its Accum ADC development roadmap to better align platform capabilities with clinical development requirements and partnering considerations, with the goal of enabling more effective and better-tolerated ADC therapies. This approach reinforces Accum’s potential as a next-generation intracellular delivery solution for complex biologics. To explore partnering opportunities or schedule a meeting, please contact [email protected].

(Press release, Defence Therapeutics, FEB 10, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-aligns-accum-adc-strategy-through-multidisciplinary-scientific-advisory-board [SID1234662562])

On February 10, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519, hereafter "Chugai") and Araris Biotech AG (hereafter "Araris") reported that Chugai has exercised its option under the Research Collaboration and Option to License Agreement ("RCO") previously announced by Araris in 2025. The exercised option grants Chugai a license to Araris’ proprietary AraLinQ linker-payload platform for the generation of novel ADCs against one target selected by Chugai.

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"Araris’ innovative AraLinQ technology is expected to deliver therapeutic effects in a tumor-selective manner by efficiently conjugating multiple anticancer payloads to a single antibody. By combining this technology with our core strength in antibody engineering, we aim to create innovative cancer therapeutics with enhanced efficacy and safety," said Dr. Osamu Okuda, President and CEO of Chugai.

"We are very pleased that Chugai has elected to exercise its option to license our AraLinQ technology for the development of next-generation ADCs with enhanced efficacy and tolerability. We are proud of the scientific progress achieved through this collaboration to date and look forward to seeing this program advance toward the clinic" said Dr. Dragan Grabulovski, CEO of Araris.

Dr. Filippo Mulinacci, CBO of Araris, stated: "Chugai’s decision to license AraLinQ technology represents a significant milestone for Araris. It further validates the scientific progress achieved by our team and reinforces Araris’ positioning as a partner of choice for the development of highly differentiated, multi-payload ADCs with antibody-like pharmacokinetics and exceptional linker stability."

With the exercise of the option, Araris will receive an immediate upfront payment and may receive additional milestone payments and royalties on potential commercial sales. The overall RCO provides for a total potential consideration of approximately up to USD 780 million, subject to the exercise of all options and achievement of certain milestones.

(Press release, Chugai, FEB 10, 2026, View Source [SID1234662560])