On August 5, 2026 Eli Lilly and Company (NYSE: LLY) reported its financial results for the second quarter of 2026 and provided updated 2026 financial guidance.

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"Lilly’s momentum continues, as we delivered 48% revenue growth and raised our full-year guidance," said David A. Ricks, Lilly chair and CEO. "At the same time, Lilly is building for the future. With our next-generation weight-loss medicine retatrutide and its complete clinical data package in hand, new manufacturing capacity coming online, and exciting new assets entering our pipeline through business development, Lilly’s future, after 150 years, has never been brighter."

Financial Results
$ in millions, except
per share data
Second-Quarter
2026 2025 % Change
Revenue $ 22,974 $ 15,558 48%
Net income – Reported 7,095 5,661 25%
Earnings per share – Reported(1)
7.94 6.29 26%
Net income – Non-GAAP 7,493 5,680 32%
Earnings per share – Non-GAAP(1)
8.38 6.31 33%
(1) Q2 2026 reported and non-GAAP EPS included $3.03 of acquired IPR&D charges compared to $0.14 in Q2 2025

A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."

Second-Quarter Reported Results
In Q2 2026, worldwide revenue was $23.0 billion, an increase of 48% compared with Q2 2025, driven by a 60% increase in volume, partially offset by a 13% decrease in realized prices. Key Products1 revenue grew to $15.7 billion in Q2 2026, led by Mounjaro and Zepbound. Key Products revenue in the Immunology, Oncology, and Neuroscience therapeutic areas grew 121% in Q2 2026 compared to Q2 2025.

Revenue in the U.S. increased 33% to $14.4 billion, driven by a 37% increase in volume, partially offset by a 3% decrease in realized prices. The increase in U.S. volume was driven by Zepbound and Mounjaro. The decline in realized prices was primarily driven by Zepbound and Mounjaro, partially offset by adjustments to estimates for rebates and discounts primarily driven by Trulicity, Zepbound, and Mounjaro. Excluding these adjustments, U.S. price would have declined by approximately 9%.

Revenue outside the U.S. increased 80% to $8.6 billion, driven by a 113% increase in volume, partially offset by a 36% decrease in realized prices. The lower realized prices outside the U.S. were driven primarily by the addition of Mounjaro to the National Reimbursement Drug List (NRDL) in China. The volume increase outside the U.S. was driven by Mounjaro. Jardiance revenue outside the U.S. included a sales-based milestone of $250 million in Q2 2026, associated with the company’s collaboration with Boehringer Ingelheim.

Gross margin increased 50% to $19.7 billion in Q2 2026. Gross margin as a percent of revenue was 85.8%, an increase of 1.5 percentage points versus the same quarter last year. The increase was primarily driven by improved cost of production and favorable product mix, partially offset by lower realized prices.

In Q2 2026, research and development expenses increased 14% to $3.8 billion, or 17% of revenue, driven by continued investments in the company’s early and late-stage portfolio.

Marketing, selling, and administrative expenses increased 25% to $3.4 billion in Q2 2026, primarily driven by promotional efforts supporting ongoing and planned launches.

In Q2 2026, the company recognized acquired in-process research and development (IPR&D) charges of
$2.8 billion compared with $154 million in Q2 2025. The Q2 2026 charges primarily related to the acquisitions of Orna Therapeutics, Inc. and Ajax Therapeutics, Inc.

Asset impairment, restructuring and other special charges of $703 million in Q2 2026 were primarily related to the accelerated vesting of employee equity awards and other acquisition and integration costs associated with the closing of our acquisitions of Kelonia Therapeutics, Inc. and Centessa Pharmaceuticals plc. In Q2 2025, there were no asset impairment, restructuring and other special charges.

The effective tax rate was 23.3% in Q2 2026 compared with 16.5% in Q2 2025, primarily driven by the unfavorable tax impact of non-deductible acquired IPR&D charges in Q2 2026.

In Q2 2026, net income and earnings per share (EPS) were $7.1 billion and $7.94, respectively, compared with net income of $5.7 billion and EPS of $6.29 in Q2 2025. EPS in Q2 2026 and Q2 2025 included acquired IPR&D charges of $3.03 and $0.14, respectively.

Second-Quarter Non-GAAP Measures
On a non-GAAP basis, Q2 2026 gross margin increased 50% to $19.8 billion. Gross margin as a percent of revenue was 86.3%, an increase of 1.3 percentage points versus the same quarter last year. The increase was primarily driven by improved cost of production and favorable product mix, partially offset by lower realized prices.

The non-GAAP effective tax rate was 22.2% in Q2 2026 compared with 16.5% in Q2 2025, primarily driven by the unfavorable tax impact of non-deductible acquired IPR&D charges in Q2 2026.

On a non-GAAP basis, Q2 2026 net income and EPS were $7.5 billion and $8.38, respectively, compared with net income of $5.7 billion and EPS of $6.31 in Q2 2025. Non-GAAP EPS in Q2 2026 and Q2 2025 included acquired IPR&D charges of $3.03 and $0.14, respectively.

For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release.

Second-Quarter
2026 2025 % Change
Earnings per share (reported) $ 7.94 $ 6.29 26%
Amortization of intangible assets .11 .11
Asset impairment, restructuring and other special charges .72 —
Net gains on investments in equity securities (.39) (.09)
Earnings per share (non-GAAP) $ 8.38 $ 6.31 33%
Acquired IPR&D 3.03 .14 NM
Numbers may not add due to rounding
NM – not meaningful

4

Selected Revenue Highlights
(Dollars in millions)
Second-Quarter
Year-to-Date
Selected Products 2026 2025 % Change 2026 2025 % Change
Mounjaro $ 9,943 $ 5,199 91% $ 18,605 $ 9,041 106%
Zepbound(1)
4,928 3,381 46% 9,088 5,693 60%
Jaypirca
192 123 56% 357 215 66%
Ebglyss
201 87 131% 346 147 135%
Kisunla
167 49 NM 291 70 NM
Omvoh
102 75 36% 182 112 62%
Inluriyo
75 — NM 110 — NM
Foundayo 98 — NM 98 — NM
Total Revenue 22,974 15,558 48% 42,773 28,286 51%
(1) Tirzepatide is marketed for obesity under the brand name Zepbound in Canada, Japan, and the United States.
NM – not meaningful

Mounjaro
For Q2 2026, worldwide Mounjaro revenue increased 91% to $9.9 billion. U.S. revenue was $4.8 billion, an increase of 45%, reflecting strong demand, partially offset by lower realized prices. Lower realized prices were partially offset by adjustments to estimates for rebates and discounts. Revenue outside the U.S. increased 172% to $5.2 billion primarily driven by volume growth, partially offset by lower realized prices driven by the addition of Mounjaro to the NRDL in Q1 2026.

Zepbound
For Q2 2026, U.S. Zepbound revenue increased 44% to $4.9 billion, primarily driven by strong demand, partially offset by lower realized prices, including previously announced reductions in cash-pay prices. Lower realized prices were partially offset by adjustments to estimates for rebates and discounts.

Lilly shared numerous updates recently on key regulatory, clinical, business development, and other events, including:
Regulatory Lilly’s Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European Union for adults with chronic lymphocytic leukemia (CLL) across all lines of therapy (announcement)
FDA approves Lilly’s EBGLYSS (lebrikizumab-lbkz) for one maintenance dose every eight weeks in patients with moderate-to-severe atopic dermatitis (announcement)
Clinical Lilly’s olomorasib receives U.S. FDA’s Breakthrough Therapy designation for the treatment of previously treated KRAS G12C-mutant advanced pancreatic cancer (announcement)
Lilly’s triple agonist, retatrutide, successful in two additional Phase 3 obesity trials, delivering significant improvements in weight and A1C (announcement)
Lilly’s Jaypirca (pirtobrutinib) significantly reduced the risk of disease progression or death by 45% when added to a venetoclax time-limited regimen in people with previously treated CLL/SLL (announcement)
Lilly’s oral GLP-1 Foundayo (orforglipron) delivered superior A1C control and weight loss in three pivotal type 2 diabetes trials (announcement)
Lilly’s Foundayo (orforglipron), the only oral GLP-1 taken without food or water restrictions, was associated with significant weight loss in women at every stage of menopause (announcement)
Lilly’s triple agonist, retatrutide, drove substantial improvements in weight, A1C, knee osteoarthritis pain, and obstructive sleep apnea, demonstrating its remarkable potential to treat obesity and its complications (announcement)
Lilly’s Retevmo (selpercatinib) demonstrated an 83% reduction in the risk of disease recurrence or death as adjuvant therapy for people with early-stage RET fusion-positive lung cancer (announcement)
A single dose of Lilly’s PCSK9 base editor, VERVE-102, reduced PCSK9 by up to 88% and LDL-C by up to 62%, with durable effects supporting its potential as a one-time treatment for hypercholesterolemia (announcement)
Lilly’s triple agonist, retatrutide, delivered powerful weight loss in pivotal Phase 3 obesity trial (announcement)
Lilly’s Foundayo and lower-dose Zepbound helped people maintain weight loss after switching from higher doses of injectable incretin therapy in two late-phase trials (announcement)
Lilly’s Omvoh (mirikizumab-mrkz) is the first and only IL-23p19 to demonstrate durable disease clearance in ulcerative colitis through four years (announcement)
Other Lilly to acquire AtaiBeckley to advance therapies for treatment-resistant depression and other mental health conditions (announcement)
What Medicare Part D patients need to know about accessing Foundayo (orforglipron) and Zepbound (tirzepatide) for weight management (announcement)
Lilly completes acquisition of Centessa Pharmaceuticals to advance treatments for sleep-wake disorders (announcement)
Foundayo and Zepbound now covered for millions of Americans (announcement)
Lilly announces three acquisitions to build infectious disease portfolio (announcement)
Lilly commits additional $4.5 billion across Indiana manufacturing sites, opens first dedicated genetic medicine facility (announcement)

For information on important public announcements, visit the news section of Lilly’s website.

2026 Financial Guidance
In addition to providing guidance for GAAP revenue, Lilly provides guidance for certain non-GAAP measures.
The following table summarizes the company’s updated full-year 2026 non-GAAP financial guidance, reflecting the continued strong revenue performance in Q2. The first half of 2026 also benefited from sales based milestones and adjustments for rebates and discounts. In addition to updates to Revenue and Performance Margin guidance, EPS guidance has been adjusted to reflect an increase of $2.78 (at the midpoint of the range) due to strong underlying business growth, offset by $3.03 associated with the Q2 acquired IPR&D charges from recent business development activity:
Prior Updated
Revenue $82 to $85 billion $85 to $87 billion
Performance Margin(1)(2)
47.0% to 48.5% 49.0% to 50.5%
Tax Rate(1)(3)
18% to 19% unchanged
Earnings per Share(1)(3)(4)
$35.50 to $37.00 $35.50 to $36.50
(1) Lilly does not provide reconciliations of forward-looking non-GAAP measures to the most directly comparable GAAP measures because comparable GAAP measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for a reconciliation. In particular, Lilly cannot reasonably predict certain items including net gains and losses on equity securities, asset impairment, acquisition or divestiture-related items, or restructuring and other adjustments, without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on Lilly’s reported results in accordance with GAAP. See Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited) table below for additional Non-GAAP information.
(2) The company defines performance margin as gross margin less research and development and marketing, selling, and administrative expenses divided by revenue.
(3) Guidance does not include acquired in-process research and development (IPR&D) incurred after June 30, 2026.
(4) Assumes shares outstanding of approximately 894 million and foreign currency exchange rate assumptions of 1.14 (Euro), 153 (Yen) and 7.1 (Yuan)

Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q2 2026 financial results conference call through a link on Lilly’s website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at 10 a.m. Eastern time today and will be available for replay via the website.

(Press release, Eli Lilly, AUG 5, 2026, View Source [SID1234669725])

On August 5, 2026 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported business and financial results for the second quarter of 2026.

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Total revenue in the second quarter grew 26% year-over-year to $44.7 million, and Galleri test revenue for the quarter grew 24% year-over-year to $42.6 million. Galleri test volume for the quarter grew 35% year-over-year to more than 61,000. Galleri test revenue in the first half of 2026 grew 30% year-over-year to $82.5 million. Galleri test volume in the first half of 2026 grew 42% year-over-year to more than 117,000. Net loss for the second quarter was $110.2 million. Gross loss was $12.6 million. Non-GAAP adjusted gross profit was $21.6 million, and non-GAAP adjusted EBITDA was $(90.3) million.1

"GRAIL continues to execute across our clinical and commercial priorities. We presented detailed performance, safety, and clinical utility results from the NHS-Galleri and PATHFINDER 2 studies at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, further establishing Galleri as the only MCED with extensive clinical validation from interventional studies in the screening population. We also expanded access through new and existing partnerships," said Josh Ofman, Chief Executive Officer at GRAIL. "Following our PMA submission earlier this year, we anticipate an FDA advisory committee in the fall."

For the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, GRAIL reported:

Revenue: Total revenue, comprised of screening and development services revenue, was $44.7 million, an increase of $9.1 million or 26%.
Net loss: Net loss was $110.2 million, an improvement of $3.7 million or 3%.
Gross loss: Gross loss was $12.6 million, an improvement of $5.2 million or 29%.
Adjusted gross profit1: Adjusted gross profit was $21.6 million, an increase of $5.4 million or 34%.
Adjusted EBITDA1: Adjusted EBITDA was $(90.3) million, an increase in adjusted EBITDA loss of $11.9 million or 15%.
_______________________________
1 See "Non-GAAP Disclosure" and the associated reconciliations for important information about our use of non-GAAP measures.

Cash position: Cash, cash equivalents, and short-term marketable securities totaled $861.6 million as of June 30, 2026.

Recent business highlights include:

Presented detailed results from the two largest multi-cancer early detection (MCED) studies completed to date, NHS-Galleri and PATHFINDER 2, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in May.

Clinical utility results from the NHS-Galleri trial showed:
While Galleri did not result in a significant decrease in combined Stage III and IV cancers, it did show reduced Stage IV diagnoses of 12 prespecified aggressive cancers by 22% and 26% in the second and third screening rounds, respectively, demonstrating a substantial reduction in late-stage cancer diagnoses. A Stage IV reduction was also observed across all cancers.
Adding Galleri to standard-of-care screening increased cancer detection fourfold.
The addition of Galleri resulted in a 128% increase in the number of Stage I and II screen detected cancers.
Galleri detected 366 Stage I and II cancers, more than the 290 cancers of any stage detected through the entirety of the U.K.’s standard-of-care cancer screening program in the control arm.
Of the 937 cancers detected by Galleri, approximately 70% were Stage I through III, approximately 40% were Stage I and II, and approximately 20% were Stage I.
Further, the addition of Galleri was associated with a 25% reduction in cancers diagnosed after emergency presentation.
Overall, these data support the potential of MCED screening at population scale to identify cancers before symptoms appear — when they can be treated more easily and are potentially curable.
Findings from PATHFINDER 2 showed:
Adding Galleri to recommended screenings, enabled approximately 60% of cancers to be identified by screening. This represents a 6.5x increase in number of cancers detected as compared with USPSTF A & B recommended screenings (breast, cervical, colorectal, and lung) and a 3x increase in number of cancers detected as compared with USPSTF A, B & C ratings (breast, cervical, colorectal, lung and prostate).
53% of newly detected cancers were identified in Stage I and II and more than two-thirds were identified at Stages I through III. Nearly half were cancers without recommended screening options.
The test accurately identified the Cancer Signal Origin (CSO) more than 90% of the time, enabling efficient diagnostic workups.
Overall, the results demonstrated substantially increased cancer detection with robust performance and a favorable safety profile.

Completed the expansion of our field sales and medical teams to continue to drive commercial momentum for the Galleri test.

Announced a collaboration with Priority Health to make the Galleri test available to its self-insured employer groups, making it the first Michigan health plan to enable employer groups to add Galleri to their existing cancer screening coverage. The health plan serves more than 1.4 million members across Michigan and beyond and previously launched coverage for Galleri in its Thrive and Thrive Plus Medicare Advantage plans in 2025.

In June, GRAIL completed a previously announced $110 million equity financing with Samsung C&T Corporation and Samsung Electronics Co., Ltd. through the purchase of GRAIL common stock. GRAIL and Samsung C&T intend to collaborate to commercialize the Galleri test in South Korea, with the potential to expand into additional Asian markets, including Japan and Singapore, subject to regulatory approvals and other conditions.

GRAIL anticipates the U.S. Food and Drug Administration (FDA) will hold an advisory committee in the fall to review the Premarket Approval (PMA) application for the Galleri multi-cancer early detection blood test. The PMA submission is focused on test performance and safety results from 25,000 consented participants in the U.S.-based PATHFINDER 2 study with one year of follow-up and from the prevalent screening round (first year) of the 140,000-participant NHS-Galleri trial, the largest, and only, randomized, controlled intended use trial of any MCED test. The submission is also supported by a bridging analysis to compare performance of the version of Galleri used in clinical trials to the updated version that has been submitted to the FDA for pre-market approval.
Conference Call and Webcast
A webcast and conference call will be held today, August 5, 2026, at 1:30 p.m. PT / 4:30 p.m. ET. Individuals interested in listening to the conference call may access it on the investor relations section of GRAIL’s website at investors.grail.com.

A replay of the webcast will be available on GRAIL’s website for 30 days.

(Press release, Grail, AUG 5, 2026, View Source [SID1234669746])

On August 5, 2026 CellFiber Co., Ltd. ("CellFiber"), a Tokyo-based biotechnology company built on its proprietary CellFiber cell encapsulation platform, and Tidewave Bio ("Tidewave"), a Los Angeles-based biotechnology company developing a universal, off-the-shelf immunotherapy platform for solid tumors, reported a collaboration to evaluate CellFiber’s closed, automated 3D cell culture platform in support of the scalable manufacturing of Tidewave’s next-generation cell immunotherapy.

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Under the collaboration, the parties have agreed to undertake a joint proof-of-concept evaluation comparing conventional planar (2D) cell culture against CellFiber’s encapsulation (3D) approach for the expansion and differentiation of immune cells relevant to Tidewave’s allogeneic platform. The work, to be conducted at CellFiber’s facility in Tokyo, is designed to generate process performance data that will drive Tidewave’s manufacturing strategy as the program advances, while demonstrating the applicability of the CellFiber platform to off-the-shelf solid tumor immunotherapy manufacturing. Any further activities beyond the proof-of-concept evaluation will be subject to separate written agreement between the parties.

"Tidewave Bio’s mission is to make next-generation cancer immunotherapy accessible to every solid tumor patient, regardless of tumor type, treatment setting, or geography," said Francois Binette, Chief Executive Officer of Tidewave Bio. "Delivering on that mission requires manufacturing approaches that can scale efficiently, reliably, and cost-effectively. We are pleased to partner with CellFiber to evaluate how their innovative encapsulation platform can support our process development strategy as we advance toward the clinic."

"Tidewave Bio is pursuing a genuinely differentiated approach to solid tumor immunotherapy, and we are excited to support their program," said Dr. Kazuchika Furuishi, Representative Director and Chief Executive Officer of CellFiber. "Our CellFiber platform was designed to remove the manufacturing bottlenecks that have historically constrained cell therapy scale-up. This collaboration is an opportunity to demonstrate the value our closed, automated 3D culture system can bring to the next generation of off-the-shelf cell therapies, and to advance our shared vision of making these therapies more widely accessible to patients."

(Press release, Tidewave Bio, AUG 5, 2026, View Source [SID1234669762])

On August 5, 2026 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the second quarter of 2026, provided an update on progress toward achieving key corporate objectives, and outlined its commercial, clinical and pipeline development milestones.

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"Exelixis continues to execute across the key pillars of our business, positioning the company to deliver on our strategic objectives for 2026 and beyond," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "For zanzalintinib, our next potential franchise molecule, the R&D organization is executing on our priority goals for pivotal data readouts, clinical trial enrollment and new study initiations, while also laying the foundation for the next wave of development opportunities. Additionally, in the second quarter, we saw the continued growth of the cabozantinib franchise while advancing preparations for the potential launch of zanzalintinib in metastatic colorectal cancer, pending approval from regulatory authorities later this year. We are executing on all these initiatives while maintaining disciplined expense management and capital allocation, with a focus on simultaneously investing in R&D and returning capital to shareholders, as well as pursuing opportunistic business development when appropriate."

Second Quarter 2026 Financial Results
Total revenues for the quarter ended June 30, 2026 were $628.7 million, as compared to $568.3 million for the comparable period in 2025.
Total revenues for the quarter ended June 30, 2026 included net product revenues of $573.0 million, as compared to $520.0 million for the comparable period in 2025. The increase in net product revenues was primarily due to an increase in sales volume.

Collaboration revenues, composed of license revenues and collaboration services revenues, were $55.7 million for the quarter ended June 30, 2026, as compared to $48.2 million for the comparable period in 2025. The increase in collaboration revenues 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.

Research and development expenses for the quarter ended June 30, 2026 were $212.0 million, as compared to $200.4 million for the comparable period in 2025. The increase in research and development expenses was primarily related to increases in clinical trial costs, manufacturing costs to support our development candidates, and license and other collaboration costs, partially offset by a decrease in personnel expenses.

Selling, general and administrative expenses for the quarter ended June 30, 2026 were $147.6 million, as compared to $134.9 million for the comparable period in 2025. The increase in selling, general and administrative expenses was primarily related to increases in marketing activities and personnel expenses.

Provision for income taxes for the quarter ended June 30, 2026 was $50.6 million, as compared to $45.6 million for the comparable period in 2025.

GAAP net income for the quarter ended June 30, 2026 was $212.1 million, or $0.85 per share, basic and $0.82 per share, diluted, as compared to GAAP net income of $184.8 million, or $0.68 per share, basic and $0.65 per share, diluted, for the comparable period in 2025. GAAP net income per share for the quarter ended June 30, 2026 was favorably impacted by lower weighted-average common shares outstanding for the quarter ended June 30, 2026, as compared to the comparable period in 2025, as a result of the stock repurchase programs.
Non-GAAP net income for the quarter ended June 30, 2026 was $237.1 million, or $0.95 per share, basic and $0.91 per share, diluted, as compared to non-GAAP net income of $212.6 million, or $0.78 per share, basic and $0.75 per share, diluted, for the comparable period in 2025.

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 providing the following updated 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).
Current Guidance
(provided on August 5, 2026)
Previous Guidance
(provided on January 11, 2026)
Total revenues
$2.500 billion – $2.550 billion $2.525 billion – $2.625 billion
Net product revenues
$2.300 billion – $2.350 billion(1)
$2.325 billion – $2.425 billion(1)
Cost of goods sold, % of net product revenues 3.5% – 4.5% 3.5% – 4.5%
Research and development expenses
$825 million – $875 million(2)
$875 million – $925 million(2)
Selling, general and administrative expenses
$575 million – $625 million(3)
$575 million – $625 million(3)
Effective tax rate 21% – 23% 21% – 23%

Cabozantinib Franchise Highlights

Net product revenues generated by the cabozantinib franchise in the U.S. were $573.0 million during the second quarter of 2026, with net product revenues of $570.6 million from CABOMETYX (cabozantinib) and $2.4 million from COMETRIQ (cabozantinib). Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners, Ipsen and Takeda Pharmaceutical Company Limited, during the quarter ended June 30, 2026, Exelixis earned $53.2 million in royalty revenues.

Zanzalintinib GI Highlights

Ongoing Regulatory Review of Zanzalintinib in Combination with Atezolizumab for Previously Treated Metastatic CRC and Update on Results from the Non-Liver Metastases (NLM) Subgroup from STELLAR-303. In June 2026, Exelixis announced results from the final analysis of the dual primary endpoint of overall survival (OS) in the NLM subgroup in the phase 3 STELLAR-303 pivotal trial evaluating zanzalintinib in combination with atezolizumab versus regorafenib in previously treated non-microsatellite instability (non-MSI)-high metastatic CRC. The results showed a non-statistically significant trend in OS favoring the combination in the NLM subgroup. As previously announced in June 2025, STELLAR-303 met its other dual primary endpoint, OS in the intention-to-treat population, which included all randomized patients regardless of the presence of active liver metastases. In February 2026, the U.S. FDA accepted the company’s NDA for zanzalintinib, in combination with atezolizumab, for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026.

Phase 3 STELLAR-316 Pivotal Trial Nearing Initiation, in Collaboration with Merck and Natera. Exelixis remains on track to initiate the planned phase 3 STELLAR-316 pivotal trial of zanzalintinib in mid-2026. This Exelixis-sponsored trial will evaluate zanzalintinib, with and without KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) [KEYTRUDA QLEX is marketed outside the U.S. as KEYTRUDA SC], 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. Natera, a global leader in cell-free DNA and precision medicine, will provide its Signatera assay to identify MRD+ patients for trial enrollment. In May 2026, Exelixis announced a clinical development collaboration in which Merck, known as MSD outside of the United States and Canada, will supply KEYTRUDA QLEX injection for subcutaneous administration in combination with zanzalintinib for the trial. The primary endpoint of STELLAR-316 will be disease-free survival, with secondary endpoints including circulating tumor DNA clearance.

Enrollment Progress for Phase 2/3 STELLAR-311 Pivotal Trial. Exelixis is continuing to actively enroll patients in the phase 2/3 STELLAR-311 pivotal trial. STELLAR-311 is evaluating zanzalintinib versus everolimus as a first oral therapy in patients with advanced neuroendocrine tumors (NET), regardless of site of origin, who have received up to one prior line of therapy. The primary endpoint of the trial is progression-free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review.
Zanzalintinib GU Highlights
Topline Results for Phase 3 STELLAR-304 Pivotal Trial Expected in Second Half of 2026. In May 2026, Exelixis announced that the company expects topline results from the STELLAR-304 trial in the second half of 2026, depending on event rates. STELLAR-304 is a phase 3 pivotal trial evaluating zanzalintinib in combination with nivolumab versus sunitinib in previously untreated patients with advanced non-clear cell renal cell carcinoma (nccRCC). The primary endpoints of the trial are PFS as assessed by blinded independent radiology committee and objective response rate (ORR) per RECIST 1.1, with OS as the secondary endpoint.
Initiation of Phase 3 LITESPARK-034 Pivotal Trial as Part of Clinical Development Collaboration with Merck. In April 2026, Exelixis’ collaborator Merck initiated LITESPARK-034, a global phase 3 pivotal trial evaluating zanzalintinib in combination with WELIREG (belzutifan) versus WELIREG and placebo in second-line or later advanced renal cell carcinoma (RCC) patients who have progressed on or after both programmed death-1/ligand 1 (PD-1/L1) and vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFR-TKI) therapies in sequence or in combination. LITESPARK-034 is the second of two Merck-sponsored phase 3 pivotal trials of zanzalintinib and WELIREG in RCC under the companies’ clinical development collaboration. Merck initiated the first trial, LITESPARK-033, in December 2025. LITESPARK-033 is evaluating the combination of zanzalintinib and WELIREG versus cabozantinib in first-line advanced RCC following an immunotherapy administered in the adjuvant setting.
Zanzalintinib Development Program Expansion Opportunities
Initiation of Phase 2 STELLAR-201 Trial in Recurrent Meningioma. In May 2026, Exelixis announced the initiation of STELLAR-201, a phase 2 trial evaluating zanzalintinib in patients with recurrent Grade I/II/III meningioma with relapse or progression following radiation and/or surgery or those who are not candidates for these therapies. The primary endpoint of the trial is ORR, with secondary endpoints including PFS, duration of response (DOR) and OS. Enrollment is currently ongoing. Pending favorable results, the trial represents an opportunity for zanzalintinib to become the first and only systemic therapy for this form of meningioma, the most common primary intracranial neoplasm for which there are currently no approved systemic therapies.
Expansion of Zanzalintinib Clinical Development Program in Squamous Non-small Cell Lung Cancer (NSCLC), Metastatic Bladder Cancer and Metastatic Castration-Resistant Prostate Cancer (mCRPC). Exelixis has additional planned and ongoing zanzalintinib studies across multiple tumor types. These include STELLAR-202, a planned phase 2 trial evaluating zanzalintinib in combination with pembrolizumab in the maintenance setting in squamous NSCLC, as well as expansion cohorts in the ongoing phase 1b/2 STELLAR-002 study. The STELLAR-002 expansion cohorts are evaluating zanzalintinib monotherapy in patients with metastatic bladder cancer who have progressed following treatment with enfortumab vedotin and pembrolizumab, as well as zanzalintinib in combination with docetaxel in mCRPC patients with measurable disease. Both the bladder cancer and mCRPC expansion cohorts in the STELLAR-002 study have been initiated and enrollment is ongoing. Exelixis expects to initiate STELLAR-202 in the second half of 2026.
Corporate Highlights
Zanzalintinib and Cabozantinib Data Presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2026). Zanzalintinib and cabozantinib were the subject of numerous presentations at ASCO (Free ASCO Whitepaper) 2026, which was held from May 29 through June 2 in Chicago. Notable posters included an analysis of the contribution of atezolizumab to the efficacy of the combination with zanzalintinib in the phase 3 STELLAR-303 trial and results from a subgroup analysis of the phase 3 CABINET pivotal trial evaluating CABOMETYX in patients with previously treated advanced NET. The STELLAR-303 data support the contribution of atezolizumab to the previously observed survival benefits of zanzalintinib in combination with atezolizumab for patients with metastatic CRC. The presentation demonstrated the importance of generating data around the potential impact of anti-drug antibodies on systemic exposures or neutralization of immune checkpoint inhibitor activity, which Exelixis plans to continue to interrogate across all zanzalintinib development opportunities. The results from the CABINET subgroup analysis showed CABOMETYX provided significant improvements in PFS versus placebo in patients with NET regardless of functional status, highlighting the ability of CABOMETYX to delay disease progression for these patients.

Stock Repurchase Program (SRP) Update. In the second quarter of 2026, Exelixis repurchased $311.6 million of the company’s stock, at an average price of $47.85 per share, and completed the SRP authorized in October 2025, fulfilling its commitment to purchase a total of $750 million of the company’s stock under the October 2025 SRP before December 31, 2026. In May 2026, Exelixis’ Board of Directors authorized the repurchase of up to an additional $750 million of the company’s outstanding common stock before December 31, 2027 (May 2026 SRP). Exelixis began executing stock repurchases under the May 2026 SRP in the second quarter of 2026. Since Exelixis’ Board of Directors authorized the first SRP in March 2023, Exelixis has repurchased a total of $2.9 billion of the company’s common stock, retiring 93.3 million shares, at an average price of $31.12 per share, as of the end of the second quarter of 2026.

Stock repurchases under the May 2026 SRP 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 program 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 the company’s common stock and general market conditions. The program does not obligate Exelixis to acquire any amount of its common stock, and may be modified, suspended or discontinued at any time without prior notice.

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 July 3, 2026 and July 4, 2025, are indicated as being as of and for the periods ended June 30, 2026 and June 30, 2025, respectively.

Conference Call and Webcast

Exelixis management will discuss the company’s financial results for the second quarter of 2026 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Wednesday, August 5, 2026.
To access the conference call, please dial (800) 715-9871 (domestic) or (646) 307-1963 (international). The Exelixis conference call ID number is 5587241. 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 be archived on www.exelixis.com for one year.

(Press release, Exelixis, AUG 5, 2026, View Source [SID1234669726])

On August 5, 2026 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, was the first to demonstrate the isolation and analysis of >99% pure circulating tumor-derived DNA (ctDNA), reported the publication of the first peer-reviewed paper describing the technology in detail – entitled "Direct analysis of transcription factor protected cfDNA in plasma by ChIP-seq: Measurement of altered CTCF binding in cancer is a novel biomarker for liquid biopsy1".

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Most current liquid biopsy methods involve deep sequencing of plasma DNA and bioinformatic analysis of the data produced to identify the presence of cancer in a patient. The biggest problem facing all liquid biopsy methods worldwide is that the vast majority of circulating DNA in blood plasma samples comes from healthy cells, not cancer cells. Volition’s new technology employs an entirely novel approach to liquid biopsy that has overcome this hurdle and produced >99% pure cancer associated plasma DNA sequence sets for liquid biopsy.

Mr. Gael Forterre, Chief Licensing Officer, Volition added:

"We are delighted that the paper detailing this breakthrough technology has been peer reviewed and published.

"We are in active discussions with several large liquid biopsy and diagnostic companies to accelerate the development of this technology, "Capture-Seq", and indeed are in the process of undertaking technical evaluations with potential licensors.

"We believe the potential use cases for Capture-Seq represent a significant commercial opportunity with a Total Addressable Market on an annualized basis of approximately $23 billion2 for the human Multi-Cancer Early Detection (MCED) use, and over $13 Billion2 for Minimum Residual Disease (MRD)."

Dr Jake Micallef, Chief Scientific Officer, Volition commented:

"Distinguishing cancer derived plasma DNA from healthy DNA when the two are mixed is problematic as they are chemically similar. As the cancer DNA may make up 1% or less of the total DNA, it is extremely problematic.

"Our manuscript describes a new liquid biopsy chemistry for isolating CTCF-DNA from plasma. Our work on CTCF-bound DNA has revealed what we believe to be an unprecedented new discovery; that there is almost no CTCF-bound DNA in healthy plasma and almost all CTCF-bound DNA in the blood of a cancer patient is derived from cancer cells – i.e. it is virtually pure circulating tumor-derived DNA.

"Removal of background normal cell free DNA from the blood to reveal this level of tumor derived DNA has been a long term goal of liquid biopsy. I believe this is a world-first and could, in my opinion, represent the biggest scientific breakthrough in cancer testing and monitoring in recent years.

"In this published paper we report a new, two-step method for preparing pure circulating tumor DNA data sets for cancer patients:

physical enrichment of the sample; and
bioinformatic removal of virtually all remaining non-tumor cfDNA sequences from the DNA sequence data set.
"This new method produced >99% pure ctDNA sequencing data sets for blood samples from cancer patients and, whilst we capture a subset of the ctDNA (i.e. not all the ctDNA in a sample), it is virtually pure cancer DNA.

"These methodological and technological breakthroughs represent a novel liquid biopsy method for a novel class of potentially thousands of liquid biopsy sequence biomarkers. Capture-Seq shows potential for both a multi-cancer early detection (MCED) approach, either alone or in combination with other tests, and the detection of Minimal Residual Disease (MRD).

"We are fast-tracking the development of Capture-Seq conducting further studies, including competing conditions and larger sample sets and working with oncology Key Opinion Leaders.

"Volition is, I believe, the first liquid biopsy company to focus on circulating cell free nucleoproteins and we have filed a number of new patents to protect this technology."

Dr Andrew Retter, Medical Consultant, Volition commented:

"From a clinical perspective, the proof of concept and early blinded validation results reported in this paper are extremely encouraging. In two independent cohorts we reported no false positives and detected 49/49 cancers in the first cohort (including 23 early stage I/II and 21 controls) and validated it in a second blinded cohort with 13/14 later stage cancers detected with 10 additional controls.

"We have also subsequently reported data from a blinded validation cohort of 81 subjects (colorectal and lung cancer patients = 59, healthy controls = 22) and are extremely encouraged by the results; the early-stage cancer detection of 95% of stage I and II cancers is particularly noteworthy.

"For patients, the potential significance is huge. If validated in larger cohorts, CTCF Capture-Seq could contribute to Multi-Cancer Early Detection (MCED) fulfilling a significant unmet clinical need.

"We also believe that Capture-Seq has the potential to play a role in cancer management, including but not limited to, Minimal Residual Disease detection and treatment monitoring, either alone or potentially in combination with other technologies too."

Pamart, D., et al. Direct analysis of transcription factor protected cfDNA in plasma by ChIP-seq: measurement of altered CTCF binding in cancer is a novel biomarker for liquid biopsy. Clin Epigenet (2026). View Source
Data on File : Volition TAM Model

(Press release, VolitionRX, AUG 5, 2026, View Source [SID1234669747])