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 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 Coherus Oncology, Inc. (Nasdaq: CHRS), reported financial results for the second quarter 2026, and provided an overview of recent business highlights.

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"During the second quarter we continued to pursue our science-driven clinical development strategy, creating multiple avenues for long-term value creation, and look forward to further maturation of data with both tagmokitug and casdozokitug," said Denny Lanfear, Chairman and Chief Executive Officer.

"We continue to advance our pipeline studies, including completion of enrollment with casdozokitug in HCC, as well as with tagmokitug in HNSCC and CRC, with emerging evidence of clinical activity in combination with toripalimab in HNSCC. While preliminary, the activity observed to date reinforces our confidence in the Treg depletion mechanism," said Rosh Dias, MD, Chief Medical Officer.

RECENT BUSINESS HIGHLIGHTS

LOQTORZI (toripalimab-tpzi) Commercial Updates

● LOQTORZI revenue for Q2 2026 was $13.6 million, a 37% increase over $10.0 million in Q2 2025, and a 15% increase versus the $11.8 million in Q1 2026 which was impacted by severe weather events as well as normal seasonality.
● Demand trends remained strong in the second quarter, with the highest number of new patient starts since launch, normalized patient discontinuation rates following seasonal Q1 trends, and continued improvement in therapy duration, supporting further growth opportunities.
● LOQTORZI remains the only FDA-approved and available treatment in the U.S. for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC.) It is the only preferred Category 1 first-line treatment option recommended in combination with cisplatin and gemcitabine; and the only preferred subsequent-line treatment recommended by the National Comprehensive Cancer Network (NCCN).
We will continue to appropriately communicate the six-year overall survival (OS) follow-up results from the Phase 3 JUPITER-02 trial evaluating LOQTORZI plus chemotherapy versus chemotherapy alone.

ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION ONCOLOGY PIPELINE

Tagmokitug is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding.

● The Phase 1b dose-optimization studies evaluating tagmokitug in combination with toripalimab in second-line head and neck squamous cell carcinoma (HNSCC) and upper gastrointestinal adenocarcinomas remain ongoing, with initial data readouts expected in 2H 2026.
● The Phase 1b study evaluating tagmokitug in combination with toripalimab, with and without chemotherapy, in first- and second-line esophageal squamous cell carcinoma (ESCC), continues to enroll patients, with initial data expected in 2H 2026.
● The Phase 1b/2a study evaluating the tagmokitug and toripalimab combination in fourth-line and beyond colorectal cancer with no liver metastasis, is fully enrolled, with initial data expected in 2H 2026.
● A Phase 1b clinical study evaluating tagmokitug in combination with pasritamig, a T-cell engaging bispecific antibody, in patients with metastatic castration-resistant prostate cancer (mCRPC) is expected to initiate in the fall of 2026.
Casdozokitug is a first-in-class IL-27 antagonistic antibody currently being evaluated in a Phase 2 study in patients with first-line unresectable hepatocellular carcinoma (uHCC) to assess treatment benefit, safety and response biomarkers.

● Enrollment is complete in the randomized Phase 2 trial of casdozokitug/toripalimab/bevacizumab in 1L uHCC and the first data readout is expected 2H 2026.
SECOND QUARTER 2026 FINANCIAL RESULTS

Net revenue from continuing operations was $14.3 million and $10.3 million during the three months ended June 30, 2026 and 2025, respectively, and $26.6 million and $17.9 million during the six months ended June 30, 2026 and 2025, respectively. The increases were driven primarily by volume growth of LOQTORZI.

Cost of goods sold (COGS) from continuing operations was $4.2 million and $3.4 million during the three months ended June 30, 2026 and 2025, respectively, and $8.1 million and $6.0 million during the six months ended June 30, 2026 and 2025, respectively. The increases were primarily due to volume growth of LOQTORZI.

Research and development (R&D) expenses from continuing operations were $21.4 million and $26.3 million for the three months ended June 30, 2026 and 2025, respectively, and $43.0 million and $50.7 million during the six months ended June 30, 2026 and 2025, respectively. The decreases were primarily due to savings from reduced headcount, lower infrastructure costs, and lower clinical trial and R&D manufacturing costs.

Selling, general and administrative (SG&A) expenses from continuing operations were $21.0 million and $26.0 million during the three months ended June 30, 2026 and 2025, respectively, and $44.1 million and $52.1 million during the six months ended June 30, 2026 and 2025, respectively. The decreases were driven primarily by lower headcount and decreased operating costs resulting from Coherus completing the exit from the biosimilar business in 2025.

Net (loss) from continuing operations for the second quarter of 2026 was $33.3 million, or $(0.22) per share on a diluted basis, compared to a net loss of $44.9 million, or $(0.39) per share on a diluted basis, for the same period in 2025. Net loss for the first half of 2026 was $70.3 million, or $(0.48) per share on a diluted basis, compared to a net loss of $92.3 million, or $(0.80) per share on a diluted basis for the first half of 2025.

Non-GAAP net loss from continuing operations for the second quarter of 2026 was $30.1 million, or $(0.19) per share on a diluted basis, compared to $39.0 million, or $(0.34) per share for the same period in 2025. Non-GAAP net loss for the first half of 2026 was $64.1 million, or $(0.44) per share on a diluted basis, compared to $79.9 million, or $(0.69) per share for the first half of 2025. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss from continuing operations and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and marketable securities totaled $105.3 million as of June 30, 2026, compared to $172.1 million as of December 31, 2025. These balances were inclusive of Transition Service Agreement (TSA)-related collections that will be applied to associated TSA payables and accrued liabilities which totaled $22.7 million and $65.1 million as of June 30, 2026 and December 31, 2025, respectively.

Conference Call Information

When: Wednesday, August 5, 2026, starting at 5:00 p.m. Eastern Standard Time

To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: View Source

Webcast: View Source

A live and archived webcast will be available on the "Investors" section of the Coherus website at

View Source

Please dial in 15 minutes early to ensure a timely connection to the call.

(Press release, Coherus Oncology, AUG 5, 2026, View Source [SID1234669723])

On August 5, 2026 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported a number of updates on the SECuRE trial.

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Preliminary assessment of the 8 GBq 67Cu-SAR-bisPSMA dose cohorts
Patient population
The SECuRE trial is currently recruiting in the Cohort Expansion phase at the 8 GBq 67Cu-SAR-bisPSMA dose level (up to 6 doses). This preliminary efficacy and safety assessment includes all trial participants who received 8 GBq treatment cycles, comprising 16 participants from the ongoing Cohort Expansion phase and 3 participants from cohort 2 of the Dose Escalation phase (19 participants in total), by the data cut-off of 20 July 2026.

Most participants had bone metastases (63%) and had received multiple lines of therapy prior to being enrolled in the trial (79% received 5 or more previous anti-cancer regimens). Previous standard treatments included androgen deprivation therapy (ADT), radiation, first- and/or second-generation androgen receptor pathway inhibitor (ARPI), with some participants having received taxane-based therapy for metastatic hormone-sensitive disease. Some participants were exposed to an experimental prostate-specific membrane antigen (PSMA) T-Cell Engager prior to their enrolment into the SECuRE study. The median number of treatment cycles of 67Cu-SAR-bisPSMA across participants was two (range: 1-4, mean 2.1±1.0 [SD]). Three of these participants from the Cohort Expansion phase were treated with concomitant enzalutamide.

PSA and radiographic assessments
A substantial reduction in PSA was observed, with 74% (n=14) of participants achieving a PSA25 response (i.e. reductions of ≥25% in PSA), 63% (n=12) PSA50, 53% (n=10) PSA75, and 26% (n=5) PSA90 (Figure 1).

A total of 81% (n=13) of the participants who were evaluable for radiographic assessment (n=16) achieved disease control. This includes 50% (n=8) with stable disease and 31% (n=5) with complete response/undetectable disease (as assessed by RECIST and/or bone scan.

Figure 1. PSA responses of participants from cohort 2 (N=3) and Cohort Expansion (N=16) who received 1-4 doses of 8 GBq of 67Cu-SAR-bisPSMA as of 20 July 2026.

Safety profile
Participants who received 8 GBq cycles, including those in the Cohort Expansion Phase, generally developed a lower prevalence and severity of related AEs compared to the overall trial population. The most frequently reported related AEs were dry mouth and nausea, each occurring in 9 (47%) and 8 (42%) participants, respectively. Anaemia and decreased neutrophil count were each reported in 4 (21%) participants, while fatigue was reported in 5 (26%) participants. Most events were low grade (mild/moderate) and transient, with two Grade 3 events (lymphocyte and white blood cell count decreases) in 1 (5%) participant. No Grade ≥4 related events were reported.

Complete response/undetectable disease observed in seven participants in the 67Cu-SAR-bisPSMA program
Two new participants in the Cohort Expansion phase of the SECuRE trial who were evaluable at data cut-off achieved complete response as assessed by RECIST. Combined with the five previously announced cases2,3,4,5, this brings the total number of participants who achieved complete response or undetectable disease (assessed by RECIST, bone scan and/or PSA) across the 67Cu-SAR-bisPSMA program to seven. Five out of these seven participants received treatment at the 8 GBq 67Cu-SAR-bisPSMA dose level. This represents almost a third (31%) of all participants evaluable for radiographic assessment treated at the 8 GBq 67Cu-SAR-bisPSMA dose level.

The median baseline PSA among these seven participants was 90.3 ng/mL (range 3.3 – 490.3). They had received a median of 5 prior anti-cancer regimens (range 4-7). Bone metastases were present in four of seven participants (57%). Among the participants who had received 8 GBq doses, the median number of cycles was 3 (range 1-4, mean 2.8±0.8 [SD]). All seven participants had received prior second-generation ARPI.

These observations demonstrate considerable anti-tumour activity of 67Cu-SAR-bisPSMA following a small number of 8 GBq treatment cycles in metastatic castration-resistant prostate cancer (mCRPC) patients who have failed multiple lines of therapy.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The SAR-bisPSMA product continues to generate an impressive body of evidence in clinical trials and case studies, highlighting the strength of the evidence in both diagnostic and theranostic applications.

"Most impressively, despite the relatively small numbers of patients enrolled in the SECuRE trial to date, and most having received up to 2 treatment cycles at 8 GBq, we see a trend that is impossible to ignore. We continue seeing patients with mCRPC, who have gone through numerous lines of therapy prior to the SECuRE study enrolment, achieve undetectable disease and/or complete response following 67Cu-SAR-bisPSMA treatment. Seven participants have now achieved undetectable disease and/or complete response across all cohorts (assessed by RECIST, bone scan and/or PSA), and five of these are from the 8 GBq cohorts. This means that almost a third of all evaluable patients treated at this dose level have achieved a complete response and/or undetectable disease.

"The evidence of the depth and consistency of responses achievable with 67Cu-SAR-bisPSMA is further substantiated by the PSA responses across the SECuRE study in patients who received their 67Cu-SAR-bisPSMA treatments at the 8 GBq dose level. PSA reductions of ≥50% are currently at 63%, with over a quarter of patients reaching PSA90. Importantly, 67Cu-SAR-bisPSMA at the 8 GBq dose level shows a favourable safety profile, with AEs being mostly mild to moderate and transient. This highlights the potential of this therapy in earlier stages of disease, aiming to help improve treatment outcomes of a broader prostate cancer patient population.

"The SECuRE trial will continue enrolment into the Cohort Expansion Phase with Phase III registrational trial planning ongoing based on data that continues to be generated.

"The benefits we are seeing in the clinic, based on the treatment responses and favorable safety profile achieved with so few doses, are due to our unique combination of the optimised bivalent "bis" structure with the advantages offered by the beta emitter, copper-67, enabled by the proprietary sarcophagine (SAR) chelating technology. Time and time again we are seeing the benefits of this approach across both the diagnostic and therapeutic areas with this one molecule, from early detection in pre-prostatectomy patients to visualisation of biochemically recurrent prostate cancer and then to the treatment of mCRPC patients. Armed with the growing body of high-quality data, our team and collaborators continue to advance SAR-bisPSMA towards the paradigm shift it could bring to the prostate cancer space, aiming to improve the outcomes of so many patients with prostate cancer across multiple stages of their disease."

About the SECuRE trial
The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm study, planning to enroll approximately 54 participants in the US. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

The SECuRE trial consists of the Dose Escalation (Phase I) and Cohort Expansion (Phase II) Phases. Based on the data from the Dose Escalation Phase, which demonstrated a favourable safety profile and efficacy of 67Cu-SAR-bisPSMA, the SECuRE trial progressed to the Cohort Expansion at an 8 GBq dose level as per the Safety Review Committee (SRC) recommendation (up to 6 cycles per patient in total)3. Recruitment is currently ongoing for the Cohort Expansion Phase which will include 24 participants (Figure 2). A subset of participants will be treated with the combination of 8 GBq of 67Cu-SAR-bisPSMA with enzalutamide (ARPI), in line with the positive results from the Enza-p trial6 and previous discussions with and advice from key global medical experts in the field of prostate cancer.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary SAR technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

(Press release, Clarity Pharmaceuticals, AUG 5, 2026, View Source [SID1234669722])

On August 5, 2026 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology-focused biopharmaceutical company and majority-owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported an update on the expanding base of institutions ordering LYMPHIR (denileukin diftitox-cxdl) through wholesalers, continued formulary progress at priority U.S. treatment centers, and other key indicators supporting the product’s commercial launch.

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"Our commercial progress is reflected in two closely connected measures: growth in the number of institutions ordering LYMPHIR and continued expansion of the formulary approvals that enable additional institutions to begin ordering the product and treating patients," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology. "I am pleased to report that the number of new institutions ordering LYMPHIR rose, total institutional vial orders increased, formulary reviews and approvals grew, and wholesalers are reordering LYMPHIR to reflect this growth. Formulary inclusion is a key gateway to institutional ordering and patient access. The success of our targeted launch, so far, was accomplished by a small yet focused internal launch team. Together with our recently expanded commercial and medical affairs teams, we believe Citius Oncology is well positioned to broaden engagement with over 250 priority treatment centers, support continued adoption, and accelerate topline growth through the balance of the year."

LYMPHIR is now available in 42 institutions including academic oncology centers, leading National Comprehensive Cancer Network (NCCN) institutions and community infusion centers. During the quarter ended June 30, 2026, the number of new institutions increased 78% compared with the prior quarter. Vials ordered by institutions from wholesalers rose 31% during the quarter. Subsequent to the quarter ended June 30, 2026, following an increase in both the number of ordering institutions and vial demand, orders from wholesalers have begun to reflect this incremental demand. Citius revenue is recognized when wholesale orders for LYMPHIR are placed and filled.

LYMPHIR’s growing institutional footprint consists of leading academic and cancer treatment centers with recognized CTCL expertise. Formulary inclusion is an important step in the commercial adoption process. Once approved, an institution can order the product through a nationwide wholesaler network and make the therapy available for prescribing to eligible adult patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). Review times vary by institution and may range from several weeks to several months. Based on Company experience to date, institutions that add LYMPHIR to formulary have generally placed their first patient order within approximately two to six weeks. Citius Oncology anticipates more than 20 additional institutions during the current quarter, and is targeting formulary inclusion with 100 priority institutions by year-end.

The Company continues to engage leading CTCL experts through scientific exchange and educational initiatives designed to increase understanding of LYMPHIR’s clinical profile and support institutional evaluation of the therapy. At the Sixth World Congress of Cutaneous Lymphomas in Montreal, the Company met with many U.S. and international CTCL key opinion leaders. The expanded medical affairs team is expected to increase the frequency and breadth of the Company’s scientific engagement with the CTCL community.

According to Company tracking, LYMPHIR has secured near-universal payer coverage. Formulary inclusion and payer coverage address complementary requirements for market access. Together, these indicators reflect continued progress in building LYMPHIR’s commercial foundation.

About LYMPHIR (denileukin diftitox-cxdl)

LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.

In 2021, reformulated denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize reformulated denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.

(Press release, Citius Pharmaceuticals, AUG 5, 2026, View Source [SID1234669721])