On February 26, 2026 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported financial results for the fourth quarter and full year ended December 31, 2025 and recent business highlights related to the commercial launch of Vafseo (vadadustat) as well as its robust pipeline.

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"Vafseo commercial trends are showing marked improvement in early 2026, built on the solid foundation we created for the brand in its first year of launch," said John P. Butler, Chief Executive Officer of Akebia. "Patient access to Vafseo therapy now stands at 290,000 patients, and early data points to improved patient adherence rates, which we believe are enhanced as a result of dialysis organizations deciding to implement observed dosing protocols. These dynamics, along with the building evidence of clinical differentiation, are expected to drive significant Vafseo revenue growth in 2026 and beyond as we work toward our goal to make Vafseo standard of care for treating anemia due to CKD in patients on dialysis. Separately, we are advancing our pipeline in rare kidney disease and actively enrolling patients into the Phase 2 trial of praliciguat in FSGS. We expect to initiate an open-label rare kidney disease basket study with our tissue-targeted complement inhibitor, AKB-097, in the second half of 2026 with initial data expected in 2027. Through these efforts, we remain steadfast in working to better the lives of people impacted by kidney disease."

Vafseo Q4 2025 Commercial Updates

•Total number of prescribers increased to approximately 800 in Q4, representing an increase of 10% over the number of prescribers in Q3.
•Broadened customer base as approximately 25% of new patients in Q4 originated from dialysis organizations other than U.S. Renal Care (USRC), an increase from less than 10% in Q3.
•Patient demand was approximately $11 million. This approximately $1 million decline in demand versus Q3 was driven by fewer patient starts, which Akebia believes was a result of providers at select dialysis organizations anticipating the initiation of new in-center observed dosing protocols.
•Within centers that adopted an in-center observed dosing protocol in Q4, first refill adherence rates improved to 91% in Q4 from 75% in the first 9 months of 2025 with daily dosing.
2025 Vafseo Post Marketing Clinical Development Achievements

•In November at the American Society of Nephrology Kidney Week 2025, Dr. Glenn M. Chertow presented a post-hoc analysis of data from the INNO2VATE trials comparing dialysis patients taking vadadustat or darbepoetin alfa for CKD-related anemia. The data demonstrated statistically significant favorable outcomes in the hierarchical composite endpoint of all-cause mortality and hospitalization in patients treated with vadadustat compared to patients in the erythropoietin stimulating agent (ESA) control group.
•In July, enrolled the first patient in VOCAL, a Phase IIIb trial evaluating three times weekly (TIW) dosing of Vafseo versus ESAs, which is expected to report topline data in Q4 2026. The VOCAL trial of approximately 350 total patients also contains a sub-study of Vafseo’s impact on red blood cell characteristics.
•In June, USRC completed enrollment in VOICE, a large Phase IV trial of over 2,100 patients evaluating Vafseo TIW against standard-of-care ESAs using a hierarchical composite endpoint of all-cause mortality and all-cause hospitalization. VOICE topline results are expected in early 2027.

Rare Kidney Disease and Early-Stage Pipeline Progress

•Initiated a Phase 2 clinical trial of praliciguat, an oral, once-daily soluble guanylate cyclase (sGC) stimulator being evaluated for the treatment of biopsy-confirmed FSGS, a rare kidney disease, and dosed the first patient in December 2025. Akebia expects to enroll approximately 60 patients in this trial.
•In November 2025, Akebia acquired a humanized anti-C3d monoclonal antibody fusion protein from Q32 Bio Inc. which is designed to act as a complement inhibitor through a tissue-targeted mechanism. A Phase 2 open-label rare kidney disease basket study is expected to start in the second half of 2026 evaluating AKB-097 in IgA nephropathy, lupus nephritis and C3 glomerulopathy. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and effects on disease-relevant biomarkers, including proteinuria and measures of kidney function. Initial data is expected in 2027.

•Akebia plans to initiate a Phase 1 study of AKB-9090 in healthy volunteers. The study is expected to begin in the first half of 2026 with topline data expected by the end of the year. The initial target indication for AKB-9090 is the treatment of acute kidney injury associated with cardiac surgery.

Financial Results

•Revenues: Total revenues were $57.6 million in the fourth quarter of 2025 compared to $46.5 million in the fourth quarter of 2024, and $236.2 million for the full-year 2025 compared to $160.2 million for the full-year 2024. These increases were driven by sales of Vafseo, which was launched in the U.S. in January 2025, and an increase in Auryxia (ferric citrate) sales volumes.
◦Vafseo net product revenues were $6.2 million in the fourth quarter of 2025 and $45.8 million for the full-year 2025.

◦Auryxia net product revenues were $48.1 million in the fourth quarter of 2025 compared to $44.4 million in the fourth quarter of 2024, and $181.5 million for the full-year 2025 compared to $152.2 million for the full-year 2024. We expect generic competition for Auryxia to expand this year beyond the current authorized generic competition and therefore expect Auryxia revenues to decrease in 2026 as compared to 2025 Auryxia revenues.

◦License, collaboration and other revenues were $3.3 million in the fourth quarter of 2025 compared to $2.1 million in the fourth quarter of 2024, and $8.9 million for the full-year 2025 compared to $8.0 million for the full-year 2024.
•COGS: Cost of goods sold was $12.5 million in the fourth quarter of 2025 compared to $20.4 million in the fourth quarter of 2024, and $39.5 million for the full-year 2025 compared to $63.2 million for the full-year 2024. COGS in both periods was driven by higher Auryxia sales volumes in 2025, and was impacted by the elimination in 2025 of a quarterly $9.0 million non-cash intangible amortization charge that Akebia incurred through the fourth quarter of 2024. In addition, COGS for the full-year 2024 included a $12.3 million benefit due to our ability to sell inventory previously written-down as excess inventory. Of note, Vafseo-related COGS in both periods was derived from pre-launch inventory, which does not include the full cost of manufacturing as a portion of those inventory-related expenses were recorded as research and development expenses in the period incurred prior to Vafseo’s approval in the U.S.

•R&D Expenses: Research and development expenses were $26.6 million in the fourth quarter of 2025 compared to $11.8 million in the fourth quarter of 2024, and $62.4 million for the full-year 2025 compared to $37.7 million for the full-year 2024. The increase in expenses in both periods was driven by increased clinical trial activities related to Vafseo and our other product candidates, higher headcount related costs, as well as by a $12.8 million charge incurred during the fourth quarter of 2025 related to acquired in-process R&D costs associated with the acquisition of AKB-097 from Q32 Bio Inc.
•SG&A Expenses: Selling, general and administrative expenses were $26.1 million in the fourth quarter of 2025 compared to $27.7 million in the fourth quarter of 2024, and $107.5 million for the full-year 2025 compared to $106.5 million for the full-year 2024.
•Net Loss: Net loss was $12.2 million in the fourth quarter of 2025 compared to a net loss of $22.8 million in the fourth quarter of 2024. Net loss was $5.3 million for the full-year 2025 compared to $69.4 million for the full-year 2024. The decrease in net loss in both periods was driven by the increase in net product revenues, which was partially offset by higher expenses.

•Cash Position: Cash and cash equivalents as of December 31, 2025, were approximately $184.8 million compared to $51.9 million as of December 31, 2024. Akebia expects its existing cash resources and cash from operations will be sufficient to fund its current operating plan for at least two years.

Conference Call

Akebia will host a conference call on Thursday, February 26, 2026 at 8:00 a.m. EST to discuss fourth quarter and full year 2025 earnings. To access the call, please register by clicking on this Registration Link, and you will be provided with dial in details. To avoid delays and ensure timely connection, we encourage dialing into the conference call 15 minutes ahead of the scheduled start time.

A live webcast of the conference call will be available via the "Investors" section of Akebia’s website at: View Source/." target="_blank" title="View Source/." rel="nofollow">View Source An online archive of the webcast can be accessed via the Investors section of Akebia’s website at View Source approximately two hours after the event.

(Press release, Akebia, FEB 26, 2026, View Source [SID1234663058])

On February 26, 2026 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, reported its financial results for the fourth quarter and full year ended 2025 and provided a corporate update.

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"2025 was a year of strong business execution and continued momentum in each of our potential best-in-class programs and positioned us for an exciting 2026 with important milestones and data readouts expected from each program," stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. "2026 started with derisking events for two of our key programs, ITK and ATI-052; this included compelling ATI-052 interim Phase 1a SAD/MAD results showing strong safety and tolerability profiles, robust target engagement reinforcing the potency of the compound even at very low doses, and the opportunity for extended dosing supported by dose proportional pharmacokinetic and pharmacodynamic profiles. Since then, we have initiated two Phase 1b POC trials with ATI-052, with top line results expected from both trials in the second half of this year. With a strong cash position and several meaningful catalysts across our biologics and ITK pipeline expected this year, including top line results from the Phase 2 trial of our anti-TSLP monoclonal antibody bosakitug in AD, we are looking forward to an exciting and productive year."

Fourth Quarter 2025 Highlights and Recent Updates

Pipeline:

Biologics: Antibody Franchise

Provided Positive Interim Results of Phase 1a Single (SAD) and Multiple Ascending Dose (MAD) Trial of Investigational Bispecific Anti-TSLP/IL-4Rα Antibody ATI-052; Complete Top Line Results from SAD and MAD Cohorts Expected in the Second Quarter of 2026: ATI-052 was well tolerated and demonstrated a favorable safety profile across all single and multiple ascending dose cohorts in this Phase 1a trial. Interim results included a dose proportional pharmacokinetic (PK) profile and concentration-dependent pharmacodynamics (PD) validating the potency and specificity of the compound, including robust target engagement and near complete target occupancy even at very low doses. These results support the potential for up to every three months dosing. Additional SAD and MAD results from this trial are expected in the second quarter of 2026. (press release here)
Announced Initiation of Two Phase 1b Proof-of-Concept (POC) Trials of ATI-052: Following positive interim Phase 1a SAD/MAD results, the Company has initiated Phase 1b POC studies in AD and asthma. Top line results from both trials are expected in the second half of 2026. (press releases here and here)
Planning Underway for Phase 2b Program for ATI-052: Planning is ongoing for a Phase 2b program encompassing asthma and AD as potential first indications. The Company expects to initiate this program in the second half of 2026.
Confirmed Expectation of Top Line Results in the Second Half of 2026 from Ongoing Phase 2 Trial of Investigational Anti-TSLP Monoclonal Antibody Bosakitug: This randomized, double-blind, placebo-controlled Phase 2 trial is designed to evaluate bosakitug in approximately 96 patients with moderate-to-severe AD.
Oral Inhibitors: ITK Franchise

Aclaris’ Lead ITK Inhibitor ATI-9494 Advancing Toward Expected Investigational New Drug (IND) Application in the Second Half of 2026: Aclaris’ lead ITK inhibitor candidate ATI-9494 has demonstrated potent blockade of Th1 and Th2 responses, a prolonged half-life, and high potency against ITK, potentially enabling low drug burden, dosing flexibility, and once daily (QD) administration across a broad range of disease indications. Aclaris intends to file an IND for ATI-9494 in the second half of 2026.
ATI-2138, a Potent and Selective Investigational Inhibitor of ITK and JAK3, Demonstrated Rapid and Sustained Hair Regrowth in Validated Murine Model of Severe Alopecia Areata (AA), Further Validating Best-in-Class Potential: ATI-2138 and ritlecitinib were assessed compared to control in a reversal model of murine alopecia universalis, the most severe AA phenotype. ATI-2138 demonstrated potential best-in-class results including rapid, near complete, and sustained hair regrowth compared to control and ritlecitinib including mean hair regrowth of 93% for ATI-2138 at week 6 (end of study) compared to 78% for the same dose of ritlecitinib. Mice receiving control showed no improvement in hair regrowth. The Company is completing the assessment of additional indications that are relevant to the dual pharmacology and mechanism of action, including certain alopecias and other inflammatory disorders. (press release here)
Financial Results

Liquidity and Capital Resources

As of December 31, 2025, Aclaris had cash, cash equivalents and marketable securities of $151.4 million compared to $203.9 million as of December 31, 2024. The Company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operations into the second half of 2028, without giving effect to any potential business development transactions or financing activities, or trial execution costs associated with its planned Phase 2b program for ATI-052.

Fourth Quarter and Full Year 2025

Net loss was $19.8 million for the fourth quarter of 2025 compared to $96.6 million for the fourth quarter of 2024. Net loss was $64.9 million for the year ended December 31, 2025 compared to $132.1 million for the year ended December 31, 2024.

Total revenue was $1.3 million for the fourth quarter of 2025 compared to $9.2 million for the fourth quarter of 2024. The decrease was primarily driven by the achievement of a commercial milestone under the license agreement with Eli Lilly and Company in the fourth quarter of 2024. Total revenue was $7.8 million for the year ended December 31, 2025 compared to $18.7 million for the year ended December 31, 2024.

Research and development (R&D) expenses were $16.6 million for the quarter ended December 31, 2025 compared to $9.0 million for the prior year period. The increase was primarily due to higher product candidate manufacturing costs and preclinical and clinical development expenses for bosakitug and ATI-052, and preclinical development expenses for ATI-9494. For the year ended December 31, 2025, R&D expenses were $52.6 million compared to $33.6 million for the year ended December 31, 2024.

General and administrative (G&A) expenses were $5.6 million for the quarter ended December 31, 2025 compared to $5.0 million for the prior year period. The increase was primarily due to higher compensation-related expenses and legal expenses. For the year ended December 31, 2025, G&A expenses were $22.0 million compared to $22.2 million for the year ended December 31, 2024.

Licensing expenses were $0.9 million for the quarter ended December 31, 2025 compared to $8.6 million for the prior year period. The decrease was primarily due to a milestone achieved during the fourth quarter of 2024, the entirety of which was payable to a third party. For the year ended December 31, 2025, licensing expenses were $5.2 million compared to $12.7 million for the year ended December 31, 2024.

Revaluation of contingent consideration resulted in a $0.4 million charge for the quarter ended December 31, 2025 compared to a $1.3 million gain for the prior year period. For the year ended December 31, 2025, revaluation of contingent consideration resulted in a charge of $2.3 million compared to a $2.5 million charge for the year ended December 31, 2024.

During the quarter and year ended December 31, 2024, the Company recorded $86.9 million of in-process research and development expenses, representing the fair value of consideration expensed in connection with the in-license of bosakitug (ATI-045) and ATI-052, as well as transaction costs incurred.

(Press release, Aclaris Therapeutics, FEB 26, 2026, View Source [SID1234663057])

On February 26, 2026 The European Organisation for Research and Treatment of Cancer (EORTC) reported that it has activated the first site for the EORTC-2361-GUCG RENALUT clinical trial. This phase II, single-arm, multicentre study investigates the potential of Pluvicto (177Lu]Lu‑PSMA‑617) as a new treatment option for patients with metastatic clear cell renal cell carcinoma (ccRCC) who have progressed after one or two previous systemic therapies.

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About ccRCC
Clear cell renal cell carcinoma is the most common subtype of kidney cancer and is often driven by mutations in the Von Hippel-Lindau (VHL) gene, contributing to the tumours highly vascular nature. Most patients today receive combinations or sequences of immunotherapy and targeted therapies, such as VEGFR tyrosine kinase inhibitors. However, after progression on these regimens, options are limited. This highlights the need for new therapeutic strategies for patients in later lines of treatment.

About the RENALUT study
The RENALUT trial explores a novel therapeutic approach for metastatic ccRCC by leveraging radioligand therapy (RLT) targeting PSMA (prostate-specific membrane antigen). Although PSMA is best known for its role in prostate cancer, it is also expressed in the tumour neovasculature of ccRCC, making it a promising therapeutic target1. PSMA‑targeted imaging has shown strong performance in identifying metastatic ccRCC, supporting the idea that PSMA‑directed therapy with [177Lu]Lu‑PSMA‑617 may also be an effective treatment for this disease2,3. By building on the established use of [177Lu]Lu‑PSMA‑617 in metastatic castration resistant prostate cancer, RENALUT aims to determine whether this approach can benefit ccRCC patients who have exhausted standard treatments and currently face very limited options.

Participating sites and collaboration
The activation of the first site marks a significant milestone for this innovative trial, which will involve 11 centres across Europe. The study is led by EORTC’s Genito-Urinary Cancer Group (GUCG) and supported by a network of international collaborators.

By exploring PSMA-targeted RLT in ccRCC, RENALUT aims to address an urgent unmet need and pave the way for future treatment strategies in kidney cancer.

(Press release, EORTC, FEB 26, 2026, View Source [SID1234663053])

On February 26, 2026 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported financial results and corporate updates from the fourth quarter and full year 2025.
"These strong financial results for the fourth quarter and full year 2025 underscore our continued evolution as a global oncology leader with durable competitive advantages in clinical development and manufacturing and one of the industry’s deepest and most differentiated pipelines," said John V. Oyler, Co-Founder, Chairman and CEO at BeOne. "BRUKINSA has firmly established itself as the global leader in the BTK inhibitor class, distinguished by broad regulatory approvals, expanding geographic reach, strong physician adoption, and unmatched long-term efficacy and safety data in CLL. At the same time, we are securing new indications and expanded reimbursement for TEVIMBRA across key markets worldwide. With our late-stage, foundational hematology assets nearing commercialization and a robust solid tumor portfolio delivering encouraging data, we are well positioned to extend our leadership and drive the next phase of sustainable global growth."

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(Amounts in thousands of U.S. dollars full year GAAP amounts audited, all other amounts unaudited)

Fourth Quarter Full Year
2025 2024 % Change 2025 2024 % Change
Net product revenues $ 1,476,442 $ 1,118,035 32 % $ 5,282,061 $ 3,779,546 40 %
Other revenue $ 21,728 $ 9,789 122 % $ 60,972 $ 30,695 99 %
Total revenue $ 1,498,170 $ 1,127,824 33 % $ 5,343,033 $ 3,810,241 40 %
GAAP income (loss) from operations $ 185,035 $ (79,425) 333 % $ 447,136 $ (568,199) 179 %
Adjusted income from operations* $ 344,476 $ 78,603 338 % $ 1,099,962 $ 45,356 2325 %

GAAP net income (loss) $ 66,502 $ (151,881) 144 % $ 286,933 $ (644,786) 145 %
Adjusted net income (loss)* $ 224,979 $ 16,101 1297 % $ 917,601 $ (54,919) 1771 %
GAAP basic earnings (loss) per ADS $ 0.60 $ (1.43) 142 % $ 2.63 $ (6.12) 143 %
Adjusted basic earnings (loss) per ADS* $ 2.03 $ 0.15 1253 % $ 8.41 $ (0.52) 1717 %
GAAP diluted earnings (loss) per ADS $ 0.58 $ (1.43) 141 % $ 2.53 $ (6.12) 141 %
Adjusted diluted earnings (loss) per ADS* $ 1.95 $ 0.15 1200 % $ 8.09 $ (0.52) 1656 %
Free Cash Flow* $ 379,825 $ (17,320) 2293 % $ 941,741 $ (633,294) 249 %

* 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.

Fourth Quarter and Full Year 2025 Financial Results
Product Revenue, which represents 99% of total revenue, totaled $1.5 billion and $5.3 billion for the fourth quarter and full year of 2025, representing growth of 32% and 40%, compared to the prior-year periods.
•BRUKINSA: Global sales totaled $1.1 billion and $3.9 billion the fourth quarter and full year of 2025, representing growth of 38% and 49%, compared to the prior-year periods; U.S. sales of BRUKINSA totaled $845 million and $2.8 billion in the fourth quarter and full year of 2025, representing growth of 37% and 45%, compared to the prior-year periods.

•TEVIMBRA (tislelizumab): Global sales totaled $182 million and $737 million, in the fourth quarter and full year of 2025, representing growth of 18% and 19%, compared to the prior-year periods.

•Amgen in-licensed products: Global sales totaled $112 million and $486 million for the fourth quarter and full year of 2025, representing growth of 11% and 33%, compared to prior-year periods.

Gross Margin as a percentage of global product sales for the fourth quarter and full year of 2025 was 90.4% and 87.3%, compared to 85.6% and 84.3%, in the prior-year periods on a GAAP basis. On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of global product sales increased to 90.7% and 87.8% for the fourth quarter and full year of 2025, compared to 87.4% and 85.5%, in the prior-year periods.
Operating Expenses
The following table summarizes operating expenses for the fourth quarter of 2025 and 2024:
GAAP Non-GAAP
(in thousands, except percentages) Q4 2025 Q4 2024 % Change Q4 2025 Q4 2024 % Change
Research and development $ 615,423 $ 542,012 14 % $ 544,823 $ 474,874 15 %
Selling, general and administrative $ 555,290 $ 504,677 10 % $ 471,468 $ 433,059 9 %
Total operating expenses $ 1,170,713 $ 1,046,689 12 % $ 1,016,291 $ 907,933 12 %

The following table summarizes operating expenses for the full year 2025 and 2024:
GAAP Non-GAAP
(in thousands, except percentages) FY 2025 FY 2024 % Change FY 2025 FY 2024 % Change
Research and development $ 2,145,868 $ 1,953,295 10 % $ 1,855,979 $ 1,668,368 11 %
Selling, general and administrative $ 2,081,489 $ 1,831,056 14 % $ 1,743,118 $ 1,549,864 12 %
Total operating expenses $ 4,227,357 $ 3,784,351 12 % $ 3,599,097 $ 3,218,232 12 %

Research and Development (R&D) Expenses increased for the fourth quarter and full year of 2025 compared to the prior-year periods on both a GAAP and adjusted basis. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled nil and $0.7 million in the fourth quarter and full year of 2025, compared to $63 million and $114 million in the prior-year periods.

Selling, General and Administrative (SG&A) Expenses increased for the fourth quarter and full year of 2025 compared to the prior-year periods on both a GAAP and adjusted basis. SG&A expenses as a percentage of product sales were 38% and 39% for the fourth quarter and full year of 2025, compared to 45% and 48% in the prior-year periods.

Net Income/(Loss) and Basic/Diluted Earnings Per Share
GAAP net income for the fourth quarter and full year of 2025 was $67 million and $287 million, an increase of $218 million and $932 million, over the prior-year periods, primarily attributable to revenue growth and improved operating leverage. Included within GAAP net income for full year 2025 were $76 million of equity investment impairment charges, $25 million of non-recurring tax expenses and $20 million of timing related tax expenses in certain jurisdictions, which were primarily incurred in the fourth quarter.

For the fourth quarter of 2025, basic and diluted earnings per share were $0.05 and $0.04 per share and $0.60 and $0.58 per American Depositary Share (ADS), compared to basic loss of $0.11 per share and $1.43 per ADS in the prior-year period. For the full year of 2025, basic and diluted earnings per share were $0.20 and $0.19 per share and $2.63 and $2.53 per ADS, compared to basic loss of $0.47 per share and $6.12 per ADS in the prior-year period.
Free Cash Flow for the fourth quarter of 2025 was $380 million, representing an increase of $397 million over the prior-year period. For the full year of 2025, free cash flow was $942 million, representing an increase of $1.6 billion over the prior-year period.
For further details on BeOne’s 2025 Financial Statements, please see BeOne’s Annual Report on Form 10-K for fiscal year 2025 filed with the U.S. Securities and Exchange Commission.
Full Year 2026 Guidance
BeOne’s financial guidance is summarized below:
FY 20261
Total revenue $6.2 – $6.4 billion
GAAP gross margin % High-80% range
GAAP operating expenses2
(combined R&D and SG&A)
$4.7 – $4.9 billion
GAAP operating income2
$700 – $800 million
Non-GAAP operating income2,3
$1.4 – $1.5 billion

1Assumes January 1, 2026 foreign exchange rates.
2Does not assume any potential new, material business development activity or unusual/non-recurring items.
3Non-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 $6.2 billion to $6.4 billion includes expectations for strong revenue growth driven by BRUKINSA’s U.S. leadership position 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 in both commercial and research at a pace that continues to deliver meaningful operating leverage.

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.
•Diluted ADS outstanding: the Company expects diluted ADSs outstanding of approximately 118 million.

Fourth Quarter Business Highlights
Core Marketed Products
BRUKINSA (zanubrutinib)
•Presented 6-year landmark results from the Phase 3 SEQUOIA trial and long-term results from the Phase 3 ALPINE trial at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, confirming sustained benefit for the treatment of adult patients with treatment-naïve (TN) and relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), respectively.

Sonrotoclax (BCL2 inhibitor)
•Received first global approvals in China for the treatment of adult patients with:
◦R/R mantle cell lymphoma (MCL) who have received at least two systemic therapies, including a Bruton tyrosine kinase (BTK) inhibitor;
◦and R/R CLL/SLL who have previously received at least one systemic therapy, including a BTK inhibitor.
•Granted U.S. Food and Drug Administration (FDA) priority review for the treatment of adult patients with R/R MCL.

•Submitted Marketing Authorization Application in the European Union for the treatment of adult patients with R/R MCL.
•Enrolled first subject in Phase 3 trial in combination with BRUKINSA as a fixed-duration regimen versus acalabrutinib plus venetoclax for the treatment of adult patients with TN CLL.
TEVIMBRA (tislelizumab)
•Presented full results in partnership with Jazz Pharmaceuticals and Zymeworks from the HERIZON-GEA-01 trial in combination with ZIIHERA (zanidatamab) and chemotherapy, demonstrating statistically significant and clinically meaningful improvement in overall survival versus trastuzumab plus chemotherapy for the first-line treatment of adult patients with HER2-positive gastroesophageal adenocarcinoma (GEA).
Select Clinical-Stage Programs
Hematology
•BGB-16673 (BTK chimeric degradation activation compound (CDAC)): Presented results at ASH (Free ASH Whitepaper) from the Phase 1 CaDAnCe-101 trial for the treatment of adult patients with R/R CLL.
Breast and Gynecologic Cancers
•BG-75202 (KAT6A/B inhibitor): Initiated first in human study.

•BG-75908 (CDK2 CDAC): Initiated first in human study.
Lung Cancer
•BG-C0902 (EGFRxMETxMET antibody-drug conjugate): Initiated first in human study.
Gastrointestinal Cancers
•BGB-B2033 (GPC3x41BB bispecific antibody): Granted FDA Fast Track Designation for the treatment of adult patients with hepatocellular carcinoma who experience disease progression on or after post-systemic therapy

Anticipated R&D Milestones
Programs
Milestones
Timing
BRUKINSA
•Phase 3 MANGROVE trial interim analysis in combination with rituximab versus bendustamine plus rituximab for the treatment of adult patients with first-line MCL.
1H 2026
TEVIMBRA
•Supplemental Biologics License Application submissions in U.S. and China for the treatment of adult patients with first-line HER2-positive GEA in combination with zanidatamab.
1H 2026
•Japan regulatory approval for the treatment of adult patients with first-line gastric cancer.
2H 2026
Hematology
•Sonrotoclax (BCL2 inhibitor):
◦FDA regulatory action on New Drug Application as monotherapy treatment of adult patients with R/R MCL.
1H 2026
◦Phase 3 trial initiation for the treatment of adult patients with R/R multiple myeloma t(11;14).
2H 2026
•BGB-16673 (BTK CDAC):
◦Phase 2 potential accelerated approval submission (if data support) for the treatment of adult patients with R/R CLL.
2H 2026
Breast/Gynecologic Cancers
•BGB-43395 (CDK4 inhibitor):
◦Phase 3 trial initiation for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer.
1H 2026
Gastrointestinal Cancers
•BGB-B2033 (GPC3x41BB bispecific antibody):
◦Potentially registrational Phase 2 trial initiation.
2H 2026
Inflammation and Immunology
•BGB-45035 (IRAK4 CDAC):
◦Phase 1/2 trial data readout for the treatment of adult patients with rheumatoid arthritis.
2H 2026
•BGB-16673 (BTK CDAC):
◦Phase 1b trial data readout for the treatment of adult patients with moderate to severe chronic spontaneous urticaria.
1H 2026

BeOne’s Earnings Results Webcast
The Company’s earnings conference call for the fourth quarter and full year 2025 will be broadcast via webcast at 8:00 a.m. ET on Thursday, February 26, 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, FEB 26, 2026, View Source [SID1234663052])

On February 26, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported its attendance and presentations at upcoming investor conferences.

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Molecular Partners will also issue its full-year 2025 financial report, along with its Annual Report, on March 12, 2026.

Details of the events:

TD Cowen 46th Annual Health Care Conference
Boston, MA, March 2-4, 2026
Molecular Partners CEO Patrick Amstutz will take part in a fireside chat on Monday, March 2 at 2.30-3.00 pm ET (8.30-9.00 pm CET).

Leerink Partners Global Healthcare Conference 2026
Miami, FL, March 9-11 March, 2026
Molecular Partners CEO Patrick Amstutz will take part in a fireside chat on Monday, March 9 at 4.20-4.50 pm EDT (9.20-9.50 pm CET).

Full Year 2025 Financial Results Announcement
Thursday, March 12, 2026 at 4.00 pm EDT (9.00 pm CET).

Both fireside chats will be made available on the Company’s website under the investor section.

(Press release, Molecular Partners, FEB 26, 2026, View Source [SID1234663010])