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Charles River Laboratories Announces Second-Quarter 2026 Results

On August 5, 2026 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the second quarter ended June 27, 2026.

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Key Highlights
•Reports second-quarter revenue of $1.00 billion, GAAP loss per share of $(0.03), and non-GAAP earnings per share of $3.02.
•Organic revenue growth of 0.1% reached the highest level since the third quarter of 2023.
•Non-GAAP operating margin increased 420 basis points on a sequential basis to 20.5%, while the GAAP operating margin was essentially flat on a sequential basis at 11.9%.
•Increases 2026 guidance for revenue and non-GAAP earnings per share.
•Organic revenue guidance increasing by 150 basis points and non-GAAP earnings per share guidance increasing by $0.25 at midpoint.
•Guidance increases primarily driven by improving demand trends in the DSA segment and better-than-expected performance in the Manufacturing segment.
•Repurchased $100 million of common stock in the second quarter at an average price of $174 per share to enhance shareholder value.
•To refine and further strengthen its portfolio, the Company completed the divestitures of certain European Discovery Services sites as well as the CDMO and Cell Solutions businesses in May 2026.
•To further deepen its client relationships, the Company has joined Eli Lilly’s TuneLab AI/ML platform by providing non-clinical testing expertise to optimize drug discovery and advance R&D modernization efforts. Additionally, it has collaborated with Arovella Therapeutics to provide in vitro Next Generation Sequencing (NGS) services, which was added through the PathoQuest acquisition. This collaboration will accelerate progress towards Arovella’s alternative cancer treatment approaches.
•To advance its modernization efforts, Charles River introduced an enhanced digital pathology solution to drive efforts to further digitize and automate the Company. This AI-enabled, end-to-end workflow will deliver improved study turnaround times and increased pathologist efficiency.

Second-Quarter Results
Revenue was $1.00 billion, a decrease of 2.7% from $1.03 billion in the second quarter of 2025. On an organic basis, revenue increased 0.1%, driven by revenue growth in the Manufacturing Solutions (Manufacturing) and Discovery and Safety Assessment (DSA) segments, offset by a decline in the Research Models and Services (RMS) segment. Organic revenue growth excludes the effect of acquisitions, divestitures, and foreign currency translation.
In the second quarter of 2026, the GAAP operating margin was 11.9%, compared to 9.7% in the second quarter of 2025. The increase in the GAAP operating margin was primarily driven by the CDMO business, including lower accelerated amortization expense related to certain client relationships. The GAAP net loss available to common shareholders for the second quarter of 2026 was $(1.5) million, or $(0.03) per diluted share, compared to GAAP net income of $52.3 million, or $1.06 per diluted share for the same period in 2025. The decrease was principally due to a loss related to the CDMO and Cell Solutions divestiture totaling $63.7 million, or $1.40 per share.
On a non-GAAP basis, the second-quarter operating margin decreased to 20.5% from 22.1% in the second quarter of 2025, primarily as a result of higher study-related direct costs in the DSA segment and higher unallocated corporate costs. Non-GAAP net income was $146.2 million for the second quarter of 2026, a decrease of 5.0% from $154.0 million for the same period in 2025. Second-quarter diluted earnings per share on a non-GAAP basis were $3.02, a decrease of 3.2% from $3.12 per share in the second quarter of 2025. The non-GAAP net income and earnings per share decreases were driven primarily by the lower operating margin. The earnings per share decrease was partially offset by investment gains associated with the Company’s deferred compensation plan, which totaled a net benefit of $0.19 per share in the second quarter.

Birgit Girshick, Chief Executive Officer, said, "We made excellent progress in the second quarter on the execution of our Pathway to Purpose strategy. We are actively evaluating opportunities to modernize the Company and drive greater efficiency, to strengthen our leading drug development portfolio centered on regulated testing, and to further enhance our growth profile. We are focused on continuing to move forward on achieving our strategic initiatives and financial goals, which will strengthen our foundation and underpin our future success."

"We were encouraged that the demand environment continued to strengthen in the second quarter, particularly for our DSA segment, as evidenced by the fact that we recorded the highest net book-to-bill in nearly four years. This improvement was broad based across our global biopharmaceutical and small and mid-sized biotechnology clients, and it is our goal to continue to capture additional share of our clients’ R&D spending by providing client-centric solutions and by leveraging our global scale and deep scientific expertise. As a result of our collective efforts, we delivered on our second-quarter financial targets – exceeding our prior outlook – and are raising our revenue and non-GAAP earnings per share guidance for the year," Ms. Girshick concluded.

Second-Quarter Segment Results
Research Models and Services (RMS)
Revenue for the RMS segment was $209.5 million in the second quarter of 2026, a decrease of 1.8% from $213.3 million in the second quarter of 2025. Organic revenue decreased by 1.4%, due primarily to lower revenue for small research models in North America, as well as for research model services. The decline was partially offset by higher revenue for small research models in China.
In the second quarter of 2026, the RMS segment’s GAAP operating margin increased to 17.3% from 16.8% in the second quarter of 2025, primarily due to lower amortization of intangible assets related to the sale of the Cell Solutions business. On a non-GAAP basis, the operating margin decreased to 24.5% from 25.3%. The non-GAAP operating margin decrease was primarily driven by the impact of lower sales volume and an unfavorable geographic revenue mix.

Discovery and Safety Assessment (DSA)
Revenue for the DSA segment was $606.5 million in the second quarter of 2026, a decrease of 1.9% from $618.0 million in the second quarter of 2025. Organic revenue increased by 0.2%, driven primarily by higher study volume for regulated safety assessment services.
In the second quarter of 2026, the DSA segment’s GAAP operating margin increased to 20.5% from 19.9% in the second quarter of 2025. The increase was primarily driven by lower amortization of intangible assets related to the divestiture of certain European Discovery Services sites and lower third-party legal costs related to a non-human primate (NHP) supply matter. On a non-GAAP basis, the operating margin decreased to 25.6% from 27.4% in the second quarter of 2025. The non-GAAP operating margin decrease was primarily driven by higher study-related direct costs.

Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $188.1 million in the second quarter of 2026, a decrease of 6.3% from $200.8 million in the second quarter of 2025, primarily driven by the CDMO divestiture. Organic revenue increased 1.3%, driven primarily by higher revenue in the Microbial Solutions business.
The Manufacturing segment’s GAAP operating margin was 34.9%, compared to 6.0% in the second quarter of 2025. On a non-GAAP basis, the operating margin increased to 37.8% from 32.8% in the second quarter of 2025. The GAAP and non-GAAP increases were driven primarily by the CDMO business, including the benefit from the divestiture.
Stock Repurchase Update
The Company repurchased 1.7 million shares for a total of $300.0 million during the year-to-date period ended June 27, 2026, including 0.6 million shares for a total of $100.0 million in the second quarter of 2026. As of June 27, 2026, the Company had $700.0 million remaining under its $1.0 billion stock repurchase authorization that was approved by the Board of Directors on October 29, 2025.
2026 Guidance Update
The Company is increasing its 2026 revenue and non-GAAP earnings per share guidance, which was last updated on May 7, 2026. This increase primarily reflects the expected operational outperformance for the year, including in the second quarter, due primarily to improving demand trends in the DSA segment and better-than-expected performance in the Manufacturing segment. For the year, the Company expects the second-quarter investment gains associated with the deferred compensation plan will be largely offset by a higher tax rate, resulting in a negligible net impact to non-GAAP earnings per share.
On a GAAP basis, the Company is reducing its earnings per share guidance due primarily to the net loss related to the divestitures.
The Company’s 2026 guidance for revenue and earnings per share is as follows:
2026 GUIDANCE CURRENT PRIOR
Revenue growth/(decrease), reported (3.5)% – (2.5)%
(5.5)% – (4.0)%
Less: Contribution from acquisitions 0.0% – (0.5)%
0.0% – (0.5)%
Add: Impact from divestitures
~4.5%
~5.0%
Less: Favorable impact of foreign exchange (0.5)% – (1.0)%
(0.5)% – (1.0)%
Revenue growth/(decrease), organic (1)
0.0% – 1.0% (1.5)% – (0.5)%
GAAP EPS estimate $3.05 – $3.35
$5.35 – $5.85
Acquisition-related amortization (2) ~$2.30
~$2.30
Acquisition- and divestiture-related costs (3) ~$4.75
~$2.30
Costs associated with restructuring and efficiency initiatives (4) ~$1.20
~$0.85
Other, net (5) ($0.17)
NM
Non-GAAP EPS estimate $11.15 – $11.45 $10.80 – $11.30

Footnotes to Guidance Table:
(1) Organic revenue growth is defined as reported revenue growth adjusted for completed acquisitions, divestitures (including the CDMO and Cell Solutions businesses, as well as certain European Discovery Services sites), as well as foreign currency translation.
(2) These adjustments primarily include amortization related to intangible assets, as well as the purchase accounting step-up on inventory and certain long-term biological assets.
(3) These adjustments include costs related to the evaluation and integration of acquisitions and divestitures, as well as a net loss on divestitures and other transaction-related tax adjustments.
(4) These adjustments primarily include site consolidation (including site transition costs), severance, impairment, third-party consulting and professional services, and other costs related to the Company’s restructuring actions and efficiency initiatives. These adjustments also include gains and/or losses on the sale of certain assets and real estate.
(5) These adjustments primarily include: (i) certain venture capital and other strategic investment losses/(gains), net. This item only includes recognized gains or losses on certain investments. The Company does not forecast the future performance of these investments; and (ii) reductions to a previous $27 million inventory charge associated with an NHP supply matter. As a result of the resolution of the U.S. government investigations during fiscal year 2025, certain NHPs were subsequently utilized.

Webcast
Charles River has scheduled a live webcast on Wednesday, August 5, 2026, at 9:00 a.m. ET to discuss matters relating to this press release. To participate, please go to ir.criver.com and select the webcast link. You can also find the associated slide presentation and reconciliations of GAAP financial measures to non-GAAP financial measures on the website.

(Press release, Charles River Laboratories, AUG 5, 2026, View Source [SID1234669720])

Black Diamond Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update

On August 5, 2026 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, including silevertinib, a potential best-in-class brain-penetrant epidermal growth factor receptor (EGFR) inhibitor, reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.

"Silevertinib continued to demonstrate robust clinical activity and durable responses in frontline patients with non-classical EGFR-mutant NSCLC, as presented at ASCO (Free ASCO Whitepaper) in May," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We are particularly encouraged that no patients developed de novo brain metastases and that the CNS ORR was 86% in patients with baseline brain metastases. Approximately 80% of all patients with non-classical EGFR mutations progress in the brain, and approximately 40% of patients with non-classical EGFR-mutant NSCLC present with brain metastases at diagnosis, underscoring silevertinib’s potential to address this significant unmet medical need. We look forward to engaging with the FDA and providing an update on the pivotal development path for silevertinib in frontline NSCLC in the fourth quarter."

Recent Developments & Upcoming Milestones:
•On May 30, 2026, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, data were presented from the Phase 2 trial of silevertinib dosed at 200 mg once daily (QD) in 43 frontline NSCLC patients harboring a broad spectrum of EGFR non-classical mutations, including compound and P-Loop and C-Helix Compressing (PACC) mutations. As of an April 11, 2026 data cutoff date, results were as follows:
◦Objective Response Rate (ORR by RECIST 1.1), CNS ORR (ORR by RANO-BM), and Disease Control Rate (DCR) were 60%, 86% and 91%, respectively
◦Variant allele frequency reduction observed in all evaluable patients across 25 unique EGFR non-classical mutations, including PACC
◦Median duration of response had not been reached (95% CI: 7.0, NE)
◦Preliminary median progression-free survival of 15.2 months (95% CI: 10.8, NE)
◦No patients developed de novo brain metastases
◦23 of 43 patients (53%) remained on therapy, with the longest at 23.5 months
◦No new safety signals were observed. The rate of treatment-related adverse events greater than or equal to Grade 3 was reduced to 28% following dose reduction, and patients maintained or deepened clinical responses after dose reduction.
◦Safety, pharmacokinetics, pharmacodynamics and efficacy data support a 150 mg QD dose for pivotal development

•The Company plans to provide an update on the Phase 2 trial of silevertinib in frontline patients with non-classical EGFR-mutant (EGFRm) NSCLC in the fourth quarter of 2026.
•The Company is seeking U.S. Food and Drug Administration (FDA) feedback on a pivotal development path for silevertinib in frontline patients with non-classical EGFRm NSCLC, and expects to provide an update in the fourth quarter of 2026.
•The Phase 2 trial of silevertinib in combination with temozolomide in newly diagnosed EGFRvIII+ glioblastoma (GBM) is enrolling patients in the safety lead-in portion of the study. The Company remains on track to initiate the randomized portion of the study in the fourth quarter of 2026.
Financial Highlights
•Cash Position: Black Diamond ended the second quarter of 2026 with approximately $110.5 million in cash, cash equivalents, and investments compared to $128.7 million as of December 31, 2025. Net cash used in operations was $8.0 million for the second quarter of 2026 compared to net cash used in operations of $9.2 million for the second quarter of 2025.
•Research and Development Expenses: Research and development (R&D) expenses were $7.4 million for the second quarter of 2026, compared to $9.3 million for the same period in 2025. The decrease in R&D expenses was primarily due to the progression of our Phase 2 trial for silevertinib in NSCLC, partially offset by increased spend related to the start-up activities for the Phase 2 trial for silevertinib in GBM.
•General and Administrative Expenses: General and administrative (G&A) expenses were $4.7 million for the second quarter of 2026, compared to $4.1 million for the same period in 2025. The increase in G&A expenses was primarily due to an increase in IP-related costs.
•Net Loss: Net loss for the second quarter of 2026 was $9.9 million, as compared to a net loss of $10.6 million for the same period in 2025.
Financial Guidance
•Black Diamond ended the second quarter of 2026 with approximately $110.5 million in cash, cash equivalents, and investments which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2028.
About Silevertinib
Silevertinib is an investigational oral, covalent, brain-penetrant fourth-generation tyrosine kinase inhibitor (TKI) that selectively targets classical and more than 50 non-classical EGFR mutations in NSCLC. It is also designed to potently inhibit key EGFR alterations seen in GBM, including EGFRvIII, while avoiding the paradoxical EGFR activation reported with reversible TKIs. To date, over 200 patients with EGFRm NSCLC or EGFR-altered GBM have been treated with silevertinib.
In addition to the ongoing Phase 2 trial of silevertinib in patients with non-classical EGFRm NSCLC, the Company also initiated a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM (NCT07326566) in May 2026.

(Press release, Black Diamond Therapeutics, AUG 5, 2026, View Source [SID1234669719])

BeOne Medicines Announces Second Quarter 2026 Financial Results and Business Updates

On August 5, 2026 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported financial results and corporate updates from the second quarter of 2026.

John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, said:

"These strong second-quarter results underscore our continued growth as a global oncology leader. Our foundational hematology franchise, led by BRUKINSA, continues to gain momentum as we advance one of the industry’s deepest and most diverse pipelines. With differentiated capabilities spanning drug discovery, clinical development, manufacturing, and commercialization, we are well positioned for our next phase of global growth."

(Amounts in thousands of U.S. dollars and unaudited)

Three Months Ended Six Months Ended
June 30, June 30,
2026 2025 % Change 2026 2025 % Change
Net product revenues $ 1,679,794 $ 1,302,076 29 % $ 3,167,123 $ 2,410,606 31 %
Other revenue $ 25,277 $ 13,224 91 % $ 51,386 $ 21,973 134 %
Total revenue $ 1,705,071 $ 1,315,300 30 % $ 3,218,509 $ 2,432,579 32 %
GAAP income from operations $ 325,047 $ 87,885 270 % $ 574,949 $ 98,987 481 %
Adjusted income from operations* $ 503,029 $ 274,945 83 % $ 917,423 $ 414,302 121 %
GAAP net income $ 237,007 $ 94,320 151 % $ 464,364 $ 95,590 386 %
Adjusted net income* $ 444,497 $ 252,822 76 % $ 819,539 $ 388,959 111 %
GAAP basic EPS per ADS $ 2.12 $ 0.87 144 % $ 4.17 $ 0.89 369 %
Adjusted basic EPS per ADS* $ 3.98 $ 2.33 71 % $ 7.37 $ 3.61 104 %
GAAP diluted EPS per ADS $ 2.05 $ 0.84 144 % $ 4.01 $ 0.85 372 %
Adjusted diluted EPS per ADS* $ 3.84 $ 2.25 71 % $ 7.08 $ 3.48 103 %
Free Cash Flow* $ 435,344 $ 219,772 98 % $ 595,891 $ 207,447 187 %

* For an explanation of our use of non-GAAP financial measures, refer to the "Note Regarding Use of Non-GAAP Financial Measures" section later in this press release and for a reconciliation of each non-GAAP financial measure to the most comparable GAAP measures, see the table at the end of this press release.

Second Quarter 2026 Financial Results
Product Revenue totaled $1.7 billion for the second quarter of 2026, representing growth of 29% compared to the prior-year period.
•BRUKINSA: Global sales totaled $1.2 billion for the second quarter of 2026, representing growth of 31% compared to the prior-year period; U.S. sales of BRUKINSA totaled $893 million in the second quarter of 2026, representing growth of 31% compared to the prior-year period.
•TEVIMBRA (tislelizumab): Global sales totaled $229 million in the second quarter of 2026, representing growth of 18% compared to the prior-year period.
•Amgen in-licensed products: Global sales totaled $157 million in the second quarter of 2026, representing growth of 25% compared to the prior-year period.
Gross Margin as a percentage of global product sales for the second quarter of 2026 was 90%, compared to 87% in the prior-year period on a GAAP basis. The gross margin percentage increased due to a proportionally higher sales mix of global BRUKINSA compared to other products in the Company’s portfolio. Gross margin also benefited from productivity improvements resulting in lower costs for both BRUKINSA and TEVIMBRA.
Operating Expenses
The following table summarizes operating expenses for the second quarter of 2026:
GAAP Non-GAAP
(unaudited, in thousands, except percentages) Q2 2026 Q2 2025 % Change Q2 2026 Q2 2025 % Change
Research and development $ 612,280 $ 524,896 17 % $ 533,950 $ 444,057 20 %
Selling, general and administrative $ 593,214 $ 537,913 10 % $ 500,674 $ 441,655 13 %
Total operating expenses $ 1,205,494 $ 1,062,809 13 % $ 1,034,624 $ 885,712 17 %

The following table summarizes operating expenses for the first half of 2026:
GAAP Non-GAAP
(unaudited, in thousands, except percentages) Q2 YTD 2026 Q2 YTD 2025 % Change Q2 YTD 2026 Q2 YTD 2025 % Change
Research and development $ 1,153,504 $ 1,006,783 15 % $ 999,854 $ 865,252 16 %
Selling, general and administrative $ 1,148,311 $ 997,201 15 % $ 972,667 $ 837,166 16 %
Total operating expenses $ 2,301,815 $ 2,003,984 15 % $ 1,972,521 $ 1,702,418 16 %

Research and Development (R&D) Expenses increased for the second quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to advancing early clinical programs into late stage and preclinical programs into the clinic. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled $23.3 million and $0.5 million in the second quarter of 2026 and 2025, respectively.
Selling, General and Administrative (SG&A) Expenses increased for the second quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment to support commercial growth. SG&A expenses as a percentage of product sales were 35% for the second quarter of 2026, compared to 41% in the prior-year period.
Net Income and Basic/Diluted Earnings Per Share
GAAP net income for the second quarter of 2026 was $237 million, an increase of $143 million over the prior-year period, primarily attributable to revenue growth and improved operating leverage. Adjusted net income was $444 million, an increase of $192 million over the prior-year period.
For the second quarter of 2026, basic and diluted earnings per share were both $0.16 per share and $2.12 and $2.05 per American Depositary Share (ADS), respectively, compared to basic and diluted earnings per share of $0.07 and $0.06 per share and $0.87 and $0.84 per ADS in the prior-year period. On an adjusted basis, basic and diluted earnings per share was $0.31 and $0.30 per share and $3.98 and $3.84 per ADS, respectively, compared to $0.18 and $0.17 per share and $2.33 and $2.25 per ADS in the prior-year period.

Free Cash Flow for the second quarter of 2026 was $435 million, representing an increase of $216 million over the prior-year period.
For further details on BeOne’s Second Quarter 2026 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the second quarter of 2026 filed with the U.S. Securities and Exchange Commission.
Updated Full Year 2026 Guidance
BeOne’s financial guidance is summarized below:
Prior FY 2026 Guidance
Current FY 2026 Guidance1
Total revenue $6.3B – $6.5B $6.6B – $6.8B
GAAP gross margin % High-80% range High-80% range
GAAP operating expenses2
(combined R&D and SG&A)
$4.7B – $4.9B $4.8B – $5.0B
GAAP operating income2
$750M – $850M $1.0B – $1.1B
Non-GAAP operating income2,3
$1.45B – $1.55B $1.7B – $1.8B

1 Assumes August 1, 2026 foreign exchange rates.
2 Does not assume any potential new, material business development activity or unusual/non-recurring items.
3 Non-GAAP operating income is a financial measure that excludes from the corresponding GAAP measure costs related to share-based compensation, depreciation and amortization expense. Guidance assumes that Non-GAAP expenses track overall expense growth.
BeOne’s total revenue guidance for full year 2026 of $6.6 billion to $6.8 billion includes expectations for strong revenue growth driven by BRUKINSA’s leadership position in the U.S. and continued global expansion in both Europe and other important rest of world markets. Gross margin percentage is expected to be in the high-80% range and includes the impact of product mix and a full year of 2026 productivity improvements. Guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth.
The Company is providing the following additional guidance on items impacting net income and earnings per ADS:
•Other income (expense): Estimated range of $25 million to $50 million in expense, includes interest amortization from Royalty Pharma arrangement.
•Income tax outlook: Earnings may provide sufficient positive evidence to reverse certain valuation allowances in 2026, resulting in a material tax benefit when recognized; the timing and magnitude of a potential reversal is uncertain; prior to reversal, income tax expense should trend with earnings per historical relationship. See Form 10-Q for additional updates on income tax uncertainties.
•Diluted ADS outstanding: The Company expects diluted ADSs outstanding of approximately 118 million.
Second Quarter 2026 Business Highlights
Core Marketed Products
BRUKINSA (zanubrutinib)
•Achieved positive topline results from the Phase 3 MANGROVE study in combination with rituximab demonstrating unprecedented progression-free survival (PFS) superiority versus bendamustine plus rituximab in adult patients with previously untreated mantle cell lymphoma (MCL).
•Reported long-term 78-month follow-up data from the Phase 3 SEQUOIA study, which continue to demonstrate sustained PFS benefit for the treatment of adult patients with treatment-naïve chronic lymphocytic leukemia (CLL), at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) annual meetings.

BEQALZI (sonrotoclax)
•Received U.S. Food and Drug Administration (FDA) accelerated approval for the treatment of adult patients with relapsed or refractory (R/R) MCL, after at least two lines of systemic therapy, including a BTK inhibitor.
TEVIMBRA (tislelizumab)
•Achieved Japan regulatory approval for the treatment of adult patients with first-line gastric cancer.

ZIIHERA (zanidatamab)
•Announced New England Journal of Medicine publication of full results from the Phase 3 HERIZON-GEA-01 study plus chemotherapy, with and without TEVIMBRA, versus trastuzumab plus chemotherapy as first-line treatment for advanced/metastatic HER2+ gastroesophageal adenocarcinoma (GEA).

Select Clinical-Stage Programs
•Hosted an investor event at ASCO (Free ASCO Whitepaper) highlighting proof-of-concept data for three solid tumor programs, including BGB-43395 (CDK4 inhibitor), BGB-B2033 (GPC3x4-1BB bispecific antibody), and BG-C9074 (B7-H4 antibody-drug conjugate).
Hematology
•Tacabrutideg (BTK CDAC): Achieved last patient enrolled for Phase 3 CaDAnCe-303 (China-only) study (BGB-16673-303) in post-BTKi R/R CLL.
•BG-75202 (KAT6 A/B inhibitor): Achieved first patient enrolled into monotherapy cohort for Phase 1 study for the treatment of adult patients with acute myeloid leukemia.
Breast and Gynecological Cancers
•BGB-43395 (CDK4 inhibitor): Initiated Phase 3 study in combination with letrozole for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer.
Gastrointestinal Cancers
•BGB-58067 (MTA-cooperative PRMT5 inhibitor): Received U.S. FDA Orphan Drug Designation for the treatment of adult patients with pancreatic ductal adenocarcinoma.
Lung Cancer
•BON-110 (PD-1xVEGF-AxCTLA-4 trispecific antibody)*: Initiated first-in-human study.
Anticipated R&D Milestones
Programs
Milestones
Timing
BRUKINSA
•Regulatory submissions for the treatment of adult patients with first-line MCL in the U.S., Europe, China and Japan.
2H 2026
TEVIMBRA
•U.S. FDA regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA and chemotherapy.
2H 2026
•China regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA and chemotherapy.
1H 2027
ZIIHERA
•China regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with chemotherapy, with or without TEVIMBRA.
1H 2027
Tacabrutideg(BTK CDAC)
•Phase 2 potential submission (if data support) for the treatment of adult patients with R/R CLL.
2H 2026
BG-C9074
(B7-H4 ADC)
•Phase 3 study initiation for the treatment of adult patients with first-line ovarian cancer in maintenance setting.
2H 2026
BGB-B2033
(GPC3x4-1BB bispecific antibody)
•Pivotal Phase 3 study initiation in second-line hepatocellular carcinoma.
2H 2026

Corporate Updates
•Announced a $300 million expansion of the Company’s flagship clinical and commercial-stage manufacturing and research and development center at the Princeton West Innovation Campus in Hopewell, New Jersey, to add small molecule manufacturing capabilities.
•Appointed Felix J. Baker, Ph.D.; Elizabeth F. Mooney; and Charles L. Sawyers, M.D., to the Company’s Board of Directors.
BeOne’s Earnings Results Webcast
The Company’s earnings conference call for the second quarter 2026 will be broadcast via webcast at 8:00 a.m. ET on Wednesday, August 5, 2026, and will be accessible through the Investors section of BeOne’s website at www.beonemedicines.com. Supplemental information in the form of a slide presentation, transcript of prepared remarks, and a replay of the webcast will also be available.

(Press release, BeOne Medicines, AUG 5, 2026, View Source [SID1234669718])

Arcus Biosciences Reports Second-Quarter 2026 Financial Results and Provides a Pipeline Update

On August 5, 2026 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer and inflammatory and autoimmune diseases, reported financial results for the second quarter ended June 30, 2026 and provided a pipeline update on its clinical-stage investigational molecules and discovery programs.

"Our recent publication in Nature demonstrated our commitment to being the scientific leader in HIF-2α biology and translational medicine. We are leveraging these insights and the differentiated profile of casdatifan compared to that of the competition to ensure that casdatifan becomes the backbone of treatment across every line of therapy in kidney cancer. In the front-line setting especially, we see a clear path to be first-to-market and to provide the best options for physicians and patients," said Terry Rosen, Ph.D., chief executive officer of Arcus. "The ARC-20 platform study and strategic clinical collaborations are enabling us to efficiently pursue an integrated approach across multiple lines of therapy, and we expect this year’s upcoming ARC-20 data readouts in first-, second- and late-line settings to clarify casdatifan’s potential to transform the treatment paradigm for kidney cancer."
Casdatifan (HIF-2α inhibitor)

Development Strategy:
Arcus’s development strategy is designed to generate evidence to secure casdatifan as a backbone therapy in ccRCC so that every patient has the opportunity to benefit from casdatifan across each line of therapy over the course of their care. Arcus is executing on this strategy, including embedding casdatifan into the treatment paradigm in combination with the most commonly used dual-immunotherapy regimen in the first-line setting, nivolumab (an anti-PD-1) plus ipilimumab (an anti-CTLA-4) and the standard of care in the second-line setting, cabozantinib. Arcus’s combinations were selected to complement these two core regimens. The holistic strategy, which has the opportunity to provide the first and only HIF-2α inhibitor-based TKI-sparing first-line therapy, provides consecutive casdatifan-containing regimens in the first-, second- and third-line-plus settings highly aligned with a new treatment paradigm offered by the robust HIF-2α inhibitory profile of casdatifan. In this context, Arcus will also begin to evaluate casdatifan plus TKI-containing regimens in first-line and late-line settings, the latter in belzutifan-experienced patients. Arcus’s newly announced clinical collaborations described below support these efforts, enabling the company to evaluate numerous casdatifan-based combinations in parallel.

Casdatifan Partnership Updates:
•Arcus will receive a $15 million milestone payment from Taiho Pharmaceutical in the third quarter, triggered by PEAK-1 enrollment in Japan, under the parties’ option and license agreement. Taiho holds rights to casdatifan in Japan and certain territories in Asia.
New Clinical Collaborations:
Arcus announced three new clinical collaborations to evaluate casdatifan-based combinations in first-line and late-line ccRCC:
•Bristol Myers Squibb (BMS): Casdatifan combinations will be added as two new arms of the BMS-sponsored Phase 1/2 ROSETTA RCC-208 study in advanced RCC, evaluating casdatifan in combination with the anti-PD-L1/VEGF-A bispecific antibody pumitamig, which is being jointly developed by BioNTech and BMS.
•Summit Therapeutics: A new cohort in the ARC-20 platform study in ccRCC will evaluate casdatifan with the PD-1/VEGF bispecific antibody ivonescimab in the first-line setting.
•AVEO Oncology: A new ARC-20 cohort will evaluate casdatifan with the VEGFR TKI tivozanib in patients previously treated with belzutifan.
•Arcus has also executed one additional clinical collaboration agreement to evaluate a casdatifan combination with another anti-PD-x/VEGF bispecific antibody in first-line ccRCC, which is expected to initiate in the fourth quarter of 2026.
Development Program:
•First-Line ccRCC: The first-line setting today is divided into immunotherapy (IO/IO) regimens, representing roughly one-third of the market, and IO/TKI regimens, representing roughly two-thirds of the market. Arcus’s casdatifan strategy encompasses both, plus another novel TKI-free combination approach:
◦TKI-free (casdatifan plus IO/IO): The cohort evaluating casdatifan plus zimberelimab (anti-PD-1) and ipilimumab (anti-CTLA-4) in the ARC-20 study is currently enrolling, with the purpose of supporting Arcus’s first registrational Phase 3 study, PEAK-20, evaluating casdatifan plus nivolumab plus ipilimumab in the first-line setting, which is expected to initiate by year-end 2026.
◦TKI-containing (casdatifan plus IO/TKI): A casdatifan-based regimen inclusive of the well-established TKI axitinib, for those circumstances where physicians prefer to have a TKI-inclusive therapy, with an ARC-20 cohort expected to begin in the fourth quarter of 2026.
◦Novel TKI-free bispecific combinations (see New Clinical Collaborations above): Casdatifan in combination with anti-PD-x/VEGF bispecifics pumitamig, ivonescimab and one additional antibody with study initiations expected prior to the end of the year.
•IO-Experienced (second-line) ccRCC: Enrollment in PEAK-1, the global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib alone in IO-experienced metastatic ccRCC, is accelerating, and Arcus remains on track to complete enrollment by year-end 2026. Arcus is confident PEAK-1 will establish casdatifan plus cabozantinib as the new standard of care in the IO-experienced setting.
•Late-Line ccRCC: A new randomized ARC-20 cohort will evaluate casdatifan plus tivozanib versus tivozanib alone in patients who received two or more lines of prior therapy, including a belzutifan-containing regimen, which will elucidate the impact of prior HIF-2α inhibitor treatment on casdatifan’s activity. Enrollment in this new ARC-20 cohort is expected to begin in the fourth quarter of 2026.
Casdatifan Research Published in Nature:
In July, Arcus announced that results from the ARC-20 study evaluating casdatifan monotherapy were published in Nature. This is the first study to comprehensively connect clinical outcomes in patients treated with a HIF-2α inhibitor with peripheral biomarker changes and associated tumor biology. HIF-2α inhibition with casdatifan resulted in deep and sustained suppression of the hormone erythropoietin in blood (serum EPO), which correlated with higher response rates and longer PFS.

Planned Data Readouts:
Arcus expects multiple data readouts for casdatifan in 2026:
•In first-line ccRCC, initial data from the ARC-20 cohorts evaluating casdatifan in early-line settings, including early efficacy data for the cohort evaluating casdatifan plus zimberelimab and early safety data for the cohort evaluating casdatifan plus zimberelimab plus ipilimumab in first-line ccRCC.
•In second-line IO-experienced ccRCC, more mature overall response rate data and initial PFS data, including Kaplan-Meier curve(s), for approximately 45 patients treated in the ARC-20 cohort evaluating casdatifan plus cabozantinib. All patients will have had at least 18 months of follow-up.
•In late-line ccRCC, updated data from the ARC-20 monotherapy cohorts, including overall survival data.
Quemliclustat (small-molecule CD73 inhibitor)
•The European Medicines Agency granted orphan drug designation in May 2026 to quemliclustat for the treatment of pancreatic cancer, adding to the orphan drug designation received from the U.S. Food and Drug Administration in June 2025.
•Enrollment was completed in September 2025 for PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma. Results from this study are expected in the first half of 2027.
Immunology Portfolio
Arcus is applying its proven expertise developing potent and selective small-molecule drugs to address large markets in immunology, pursuing mechanisms that regulate key cytokines validated by existing biologics and targeting immune cell types that are central to disease but historically understudied. A steady cadence of immunology molecules will be ready for advancement into the clinic, with multiple new clinical candidates expected between 2026 and 2028.
•AB102 (oral MRGPRX2 antagonist): This month, Arcus expects to initiate a first-in-human healthy volunteer study of AB102, a highly selective oral MRGPRX2 antagonist and potential treatment for atopic dermatitis and chronic spontaneous urticaria.
◦In May, Arcus presented preclinical data for AB102 in an oral presentation at the Society for Investigative Dermatology Annual Meeting, which showed its ability to fully block MRGPRX2-dependent mast cell degranulation and transcriptional activation in LAD2 and primary skin mast cells as well as its inhibition of all common human MRGPRX2 variants.
◦A proof-of-concept study evaluating AB102 as a potential oral therapy for patients with chronic spontaneous urticaria is expected in mid-2027.
•TNF Inhibitor: Arcus has selected a development candidate as an oral small-molecule TNF inhibitor, a potential treatment for rheumatoid arthritis, psoriasis and inflammatory bowel disease, which is expected to enter the clinic in early 2027.
◦The molecule is designed to selectively block TNFR1 signaling, which could lead to better safety and efficacy than those of approved anti-TNF antibodies that block both TNFR1 and TNFR2 signaling, the latter of which can paradoxically lead to an inflammatory response in some patients.
◦At the European Alliance of Associations for Rheumatology Annual Meeting 2026, Arcus presented data on its small-molecule approach to TNF inhibition, advancing research in conditions such as RA and IBD.
•Additional Targets: Arcus is advancing additional programs across its immunology portfolio. Arcus’s programs for a small-molecule CCR6 antagonist for psoriasis and inflammatory bowel disease, a STAT6 small molecule program for atopic dermatitis and asthma, a CD89 monoclonal antibody program for the treatment of rheumatoid arthritis, and a CD40L small molecule program for the treatment of multiple sclerosis and systemic lupus erythematosus, are each expected to deliver IND-ready candidates by the end of 2027.
Anti-TIGIT Program and Related Partnerships
•Following the discontinuations of the Arcus and Gilead STAR-221 and STAR-121 studies in upper gastrointestinal cancer and non-small cell lung cancer (NSCLC), respectively, Arcus and AstraZeneca will discontinue the Phase 3 PACIFIC-8 study, evaluating domvanalimab in combination with durvalumab versus durvalumab alone in patients with PD-L1 positive, Stage III unresectable NSCLC.

•In connection with the wind-down of these Phase 3 trials and resulting streamlined operational relationship with Arcus, Gilead has relinquished its three seats on Arcus’s Board of Directors, effective as of August 5, 2026.
Financial Results for Second Quarter 2026:
•Cash, Cash Equivalents and Marketable Securities were $775 million as of June 30, 2026, compared to $1.0 billion as of December 31, 2025. The decrease during the period is primarily due to the use of cash in our research and development activities. Arcus expects to end 2026 with approximately $600 million in cash. Based on the existing business plan, Arcus believes that its cash, cash equivalents and marketable securities will be sufficient to fund its planned level of operations until at least the second half of 2028.
•Revenues were $41 million for the second quarter 2026, compared to $160 million for the same period in 2025. The decrease in revenue was primarily driven by the cumulative catch-up from license and development services revenue of $143 million in 2025 relating to pausing future development of etrumadenant and Gilead’s related return of its license to the program, partially offset by an increase in access rights revenues recognized in June 2026 related to the expiration of Gilead’s option rights and increased revenues related to programs optioned under the Taiho Collaboration Agreement. Arcus expects to recognize GAAP revenue of between $65 million and $75 million for the full year 2026.
•Research and Development (R&D) Expenses were $113 million for the second quarter 2026, compared to $139 million for the same period in 2025. The decrease was due to (i) late-stage development activities decreasing primarily due to the wind down of the domvanalimab program and the completion of enrollment of PRISM-1, partially offset by increasing activities in our Phase 3 studies for casdatifan; (ii) early-stage development activities decreasing primarily due to the wind down of Phase 2 studies related to domvanalimab and lower Phase 2 study costs for casdatifan; partially offset by (iii) partnership reimbursements decreasing, primarily due to Gilead-led activities representing a larger share of total joint development costs and a shift towards programs fully funded by us. Non-cash stock-based compensation expense was $9 million for the second quarter 2026, compared to $8 million for the same period in 2025. For the second quarters 2026 and 2025, Arcus recognized gross reimbursements of $17 million and $33 million, respectively, for shared expenses from its collaborations. R&D expenses by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements.
Arcus expects R&D expenses to continue to decline in the near-term relative to what we have incurred as we wind down studies for domvanalimab. Streamlining initiatives Arcus has undertaken across its R&D operations in connection with this wind-down, together with efficiencies the company is pursuing across its programs outside the Gilead collaboration, are expected to further reduce costs. These decreases will be partially offset by increased investment in the development of casdatifan and advancement of our small-molecule immunology programs.
•General and Administrative (G&A) Expenses were $24 million for the second quarter 2026, compared to $29 million for the same period in 2025. The decrease was primarily due to streamlining initiatives Arcus has undertaken across its operations. Non-cash stock-based compensation expense was $6 million for the second quarter 2026, compared to $7 million for the same period in 2025.
•Net Income (Loss) was $91 million net loss for the second quarter 2026, compared to $— million for the same period in 2025.
Conference Call Information
Arcus will host a conference call and webcast today, August 5, 2026, at 1:30 PM PT/4:30 PM ET to discuss its second-quarter 2026 financial results and pipeline updates. To access the call, please dial +1 (585) 542-9983 (local) or +1 (833) 461-5787 (toll-free), using Meeting ID: 156828313. Participants may also register for the call online using the following link: View Source To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay of the webcast will be available following the live event.

(Press release, Arcus Biosciences, AUG 5, 2026, View Source [SID1234669717])

Sandoz delivers strong H1 2026 results, with outstanding biosimilar growth in the second quarter

On August 5, 2026 Sandoz (SIX: SDZ; OTCQX: SDZNY), the global leader in affordable medicines, reported its financial results for the first half of 2026 and net-sales performance for the second quarter of 2026.

H1 2026 RESULTS

H1 net sales up by 5% at constant currencies (CC) to USD 5,761 million
Anti-infective B2B[1] headwind on net sales of one percentage point at CC. Impact all in Q1
Q2 2026 net sales up by 7% at CC, with all regions contributing to outstanding biosimilar growth of 22% at CC; generics returned to growth of 1% at CC in second quarter
Biosimilars represented record 33% of total net sales in first half (H1 2025: 29%)
Standout North America performance in H1, driven by biosimilar growth of 47% at CC
H1 core EBITDA increased by 15% in USD, resulting in core-EBITDA margin expansion to 20.9%
Full-year 2026 guidance confirmed

USD millions unless indicated otherwise

H1 2026

H1 2025

change %

change CC[2] %

Biosimilars

1,875

1,496

25%

20%

Generics

3,886

3,736

-1%

Net sales

5,761

5,232

10%

Core EBITDA

1,206

1,046

15%

Core-EBITDA margin

20.9%

20.0%

Core diluted earnings per share

USD 1.71

USD 1.46

17%

11%

Management free cash flow

503

USD millions unless indicated otherwise

Q2 2026

Q2 2025

change %

change CC %

Biosimilars

1,022

825

24%

22%

Generics

1,983

1,927

Net sales

3,005

2,752

Richard Saynor, Chief Executive Officer of Sandoz, said: "Sandoz delivered excellent progress during the first half of the year, building further momentum across the business and reinforcing the growth trajectory. The sales result in the second quarter was particularly encouraging, driven by an outstanding biosimilar performance. Biosimilars now represent a record one-third of net sales, reflecting our ability to successfully translate innovation into launch execution. We added four additional in-house assets to our industry-leading biosimilars pipeline, taking the total to 36. I was also delighted by more progress made in profitability and cash generation, while we continue to invest in sustainable long-term growth.

"The consistent high-growth profile of our biosimilars reinforces our conviction that Sandoz is uniquely well positioned for the opportunities ahead. Our expanding portfolio and pipeline, combined with an increasingly streamlined regulatory environment and the forthcoming completion of our vertically integrated biosimilars platform, will further strengthen our leadership position. We look forward to sharing our plans to maximise value in our golden decade for biosimilars at our Capital Markets Day in September."

H1 2026 FINANCIAL HIGHLIGHTS

H1 net sales of USD 5.8 billion (H1 2025: USD 5.2 billion), up by 5% at CC
Biosimilar net sales delivered excellent growth of 20% at CC across all regions in the first half, with North America increasing by 47% at CC and recent launches, notably Wyost & Jubbonti (denosumab), performing well
The 10 largest-selling medicines grew by a combined 14% at CC in H1 and represented 35% of net sales
A H1 core-EBITDA margin of 20.9%, reflecting a 90-basis points year-on-year improvement (H1 2025: 20.0%), driven by an improved mix of sales, cost-price savings and operating leverage
Increased capital expenditures (capex) in the first half; management free cash flow, however, remained strong at an unchanged USD 503 million. Free cash flow of USD 337 million (H1 2025: USD 207 million)
Core diluted earnings per share of USD 1.71 in H1 represented growth of 17% in USD

BUSINESS HIGHLIGHTS

Sandoz recently announced that it will host a Capital Markets Day in London on 8 September, focused on ‘maximising Sandoz value in its golden decade for biosimilars’. The Company will also host an analyst and investor site visit in Slovenia on 9-10 November, providing participants with the opportunity to visit the expanding biosimilar development and manufacturing network
In July, it was announced that Sandoz will be included in the Swiss Market Index, Switzerland’s leading blue-chip equity index, effective from 21 September
Sandoz recently advanced from third to second position in terms of gross sales of biosimilar and generic medicines in North America[3]
Marking 80 years of antibiotic manufacturing in Europe and 20 years since the approval of the world’s first biosimilar medicine, Omnitrope (somatropin), Sandoz celebrated these milestones through anniversary events, highlighting its heritage in affordable medicines, leadership in biosimilars and the importance of resilient European-medicines production
A new biosimilar development centre in Ljubljana, Slovenia, was officially opened in June, further strengthening the Company’s in-house development capabilities and supporting its long-term biosimilars growth strateg
Sandoz’s industry-leading biosimilars pipeline expanded during the period by four additional in-house assets, namely through sotatercept, polatuzumab vedotin, burosumab and anifrolumab, bringing the total biosimilars pipeline to 36[4] assets
In July, the Company announced that the Agência Nacional de Vigilância Sanitária granted marketing authorisation for Owozy (semaglutide). This marks the first GLP-1 approval for Sandoz, which the Company will commercialise in Brazil in partnership with Adalvo
The European Commission recently granted marketing authorisation for Bysumlog (insulin lispro) and Dazparda (insulin aspart), strengthening Sandoz’s position in diabetes and expanding access to affordable treatment options for patients across Europe
In June, the US Food and Drug Administration accepted for review two Abbreviated New Drug Applications for proposed generic tirzepatide autoinjectors, marking an important step in advancing the Company’s growing GLP-1 pipeline
Sandoz recently announced that it has entered into a settlement agreement with the leadership of the consortium of 43 US states and territories to resolve all claims brought by the remaining litigating states and territories against the Company concerning alleged anti-competitive conduct in the US market for generic medicines. Sandoz US has also entered into a settlement agreement with the indirect reseller plaintiffs class. When these two settlements will be completed, Sandoz US will have resolved all claims brought by US federal or state governments against the Company stemming from their investigations of the US generic medicine market from more than a decade ago and all the pending class actions related to this legacy matter. The only remaining anti-trust claims against the Company in the US generic antitrust litigation are those brought by individual plaintiffs who opted out of class settlements. These settlements do not affect full-year 2026 guidance or the Sandoz mid-term outlook
The Company’s greenhouse-gas reduction targets were recently validated by the Science Based Targets initiative, including combined Scope 1 and 2 emissions reductions of 42% by 2030 and 63% by 2035, respectively
Several key leadership appointments were announced in the period to support the Company’s next phase of growth, including Pascal Bouye as President, Generics Manufacturing & Supply, Keren Haruvi assuming responsibility for global M&A in addition to her current role and Simon Goeller as Country President, Germany

FULL-YEAR 2026 GUIDANCE

Sandoz anticipates continued growth in 2026, partly reflecting the expected performance of recently launched biosimilars. This growth, alongside a favourable shift in the mix of sales, further operating efficiencies and cost discipline, is expected to result in core-EBITDA margin expansion in 2026.

As a result, the Company confirms its expectations for the year:

Net sales to grow at CC by a mid-to-high single-digit percentage
Core-EBITDA margin expansion of around 100 basis points

This guidance excludes any impacts of unforeseen events or unconfirmed developments, including the potential imposition of new tariffs emanating from the US government.

No material contribution from any potential launch of generic semaglutide is expected in 2026. Partly reflecting short-term market dynamics in Germany and an outstanding biosimilars performance in North America, overall pricing is now expected to decline by a mid-single-digit percentage in 2026, compared with the previous expectation of a low-to-mid single-digit percentage decline.

CONFERENCE CALL

A conference call and webcast for investors and analysts will begin today at 9:30 CET. Details can be found here, with the accompanying presentation here.

(Press release, Sandoz, AUG 5, 2026, View Source [SID1234669670])