Galapagos Reports First Quarter 2026 Financial Results and Provides Business Update

On May 6, 2026 Galapagos NV (Euronext & NASDAQ: GLPG) reported its financial results for the first quarter of 2026 and provided a business update.

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"Having joined the company just one year ago, I’m thrilled with our progress. I am looking forward to consummating our partnership with Gilead and adding Ouro Medicines’ talented team and its portfolio of programs to our Company, including the potential first and best in class T cell engager in autoimmune diseases, gamgertamig (OM336). We are excited that our Company is rebranding as Lakefront Biotherapeutics as this name reflects our Company’s strategic evolution," said Henry Gosebruch, Chief Executive Officer of Galapagos.

Aaron Cox, Chief Financial Officer of Galapagos, added, "Following the anticipated use of cash to fund our collaboration with Gilead concerning its acquisition of Ouro Medicines, the Company will remain robustly capitalized and will have increased flexibility, including the ability to spend up to $500 million for business development independent of Gilead and not subject to our 2019 Option, License, and Collaboration Agreement with Gilead. This would also include the potential to use up to $150 million of that $500 million for share repurchases to the extent that we have available distributable reserves. In addition to the upfront consideration of $837.5 million, we anticipate additional 2026 Ouro-related cash expenditures to be in the range of €60-75 million, inclusive of R&D costs, one-time transaction costs and assuming a mid-year closing of the transaction."

First Quarter 2026 Business Update

On March 31, 2026, the Company announced that it has entered into a binding agreement (the "Framework Agreement") with Gilead Sciences, Inc. ("Gilead") (the "Transaction") in connection with Gilead’s definitive agreement to acquire all of the outstanding equity interests of US-based Ouro Medicines, LLC ("Ouro"), a privately held biotechnology company focused on developing T cell engager therapies for autoimmune diseases.

Gamgertamig (OM336) is a clinical stage BCMAxCD3 T cell engager designed to enable rapid and deep plasma and B cell depletion following a short duration, subcutaneously administered treatment course. In ongoing Phase 1/2 clinical studies, gamgertamig has demonstrated transformative efficacy and a differentiated safety profile after a single treatment cycle in severe antibody-mediated orphan diseases, including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP).

Gamgertamig has been granted both Fast Track and Orphan Drug Designation by the U.S. FDA for the treatment of AIHA and ITP and is expected to enter registrational studies as early as 2027.

BCMA-targeted T cell engagers are being investigated as a precision approach for severe inflammatory and autoimmune diseases by eliminating pathogenic B cells and plasma cells. By redirecting a patient’s own T cells toward BCMA-expressing plasma cells, clinical data suggest these agents can reduce inflammation, improve organ-level disease, and in some cases enable durable, drug-free remission without ongoing immunosuppression.

Update on Binding Agreement with Gilead

The Company expects the Transaction to close in the second quarter of 2026, subject to the fulfillment of the closing conditions.
Galapagos expects to assume substantially all of Ouro’s operating assets and personnel (approximately 20 employees), such that the Company would obtain an operating business.
Galapagos and Gilead will equally split the upfront payment of $1.675 billion (~€1.425 billion1), subject to customary adjustments, and contingent milestone payments of up to $500 million (~€425 million1).
Galapagos and Gilead will collaborate on the development of gamgertamig, with Galapagos responsible for the development costs through initiation of registrational studies, after which the development costs will be shared equally. Galapagos is eligible for up to $100 million in development milestones payments for gamgertamig in certain other indications.
Galapagos will fund its share of payments owed to KeyMed Biosciences Chengdu Co., Ltd. ("KeyMed"), comprising 25% of the milestone payments and 50% of the royalty payments that become due to KeyMed with respect to gamgertamig products. Based on Ouro’s original transaction with Keymed, Keymed is entitled to total development and commercial milestones of up to $610 million and tiered royalties of 7%-14% of net sales for gamgertamig.
Gilead will retain sole worldwide commercialization rights, including all related costs, globally outside of Keymed’s territories, and Galapagos will receive tiered royalties of 20%–23% on net sales of gamgertamig from Gilead.
Galapagos will gain a preclinical portfolio of three additional autoimmune focused programs originally from Ouro, with an opt-in for Gilead for a 50/50 profit split post clinical proof-of-concept for $75 million (~€64 million1) per program.
The proposed arrangements will amend the existing collaboration terms with Gilead to designate $500 million (~€425 million1) of Galapagos’ cash available for R&D or strategic transactions outside of Gilead partnerships, including up to $150 million (~€128 million1) of this $500 million (~€425 million1) for potential return of capital, subject to certain limitations.
In addition to the upfront payment of $837.5 million (~€713 million1), the range of spending expected (including transaction expenses, operating expenses, milestones, and royalties) in 2026 is €60-€75 million.
Following this transaction, including estimated associated R&D spend until first approval, the Company will continue to have a majority of its current cash of approximately €3B remaining for additional strategic transactions and other capital allocation priorities.

CORPORATE

At the Company’s Annual and Extraordinary Shareholders’ Meeting held on April 28, 2026 (the "AGM" and "EGM") all proposed resolutions were approved (see: press release of April 28, 2026), among other items:
the name change to Lakefront Biotherapeutics, with effect as of May 8, 2026. Our ticker on Euronext and NASDAQ (ADRs) will change to LKFT;
Gino Santini’s appointment as a member of our Board of Directors, and pursuant to a vote of our Board of Directors, Gino became the new Chair of our Board of Directors. Gino replaces Jérôme Contamine, whose four-year mandate as a member of the Board of Directors ended upon the conclusions of the AGM;
the authorization to acquire the Company’s own shares.
In April 2026, Coultreon Biopharma BV ("Coultreon"), previously named Onco3R Therapeutics BV, announced the closing of an oversubscribed $125 million Series A financing round. The financing will support the clinical development of Coultreon’s lead immunology program, COL-5671 (formerly O3R-5671), a highly selective SIK3 inhibitor in Phase 1, with potential to demonstrate clinical proof-of-concept in 2027. COL-5671 was initially developed by Galapagos and ownership was fully transferred to Coultreon in April 2025, when Galapagos provided seed financing to the company with a convertible note investment that converted into equity ownership in Coultreon in connection with Series A financing.
IMMUNOLOGY SMALL MOLECULE PIPELINE

As part of our ongoing efforts to maximize the value of the GLPG3667 program for both patients and Galapagos, we are evaluating all strategic options. The GALACELA SLE study with GLPG3667 is currently ongoing, and the final Week 48 data are expected in the second quarter of 2026.
ONCOLOGY CAR-T CELL THERAPY UPDATE

The Company announced in January 2026 the start of the wind-down of its cell therapy activities. The wind-down remains on schedule and is expected to be substantially completed by the end of the third quarter of 2026.
The Company continues to expect 2026 one-time cash costs related to the wind-down to be in the range of €125 million to €175 million.
Financial Guidance
Galapagos currently estimates 2026 cash spend related to Ouro of approximately €775 million to €790 million, inclusive of the upfront payment, transaction costs, and operating costs assuming a mid-year transaction closing. The Company expects its year end 2026 cash and financial investments balance to be in the range of €1.975 billion to €2.050 billion, which reflects a reduction in prior guidance due to expected cash usage related to the Ouro investment and a corresponding reduction in interest income. Galapagos continues to expect one-time cash restructuring costs of €125 million to €175 million related to the ongoing wind-down of the cell therapy activities. All figures assume a EUR/USD exchange rate of 1.175, consistent with year-end 2025. These estimates are subject to change and depend on the timing of closing, final transaction scope, integration activities, exchange rate fluctuations, and remaining cell therapy wind-down costs.

Financial Performance

Key figures for the first quarter of 2026 (consolidated)
(€ millions, except basic & diluted earnings/loss (-) per share)

March 31, 2026 March 31, 2025 % Change
Supply revenues 4.9 13.8 -64%
Collaboration revenues 1.6 61.2 -97%
Total net revenues 6.5 75.0 -91%
Cost of sales (4.8) (13.8) -65%
R&D expenses (31.0) (182.7) -83%

G&A1 and S&M2 expenses (35.5) (43.8) -19%
Other operating income 1.1 6.6 -83%
Operating loss (63.7) (158.7)

Fair value adjustments and net exch­ange differences 64.3 (9.4)
Net other financial result 13.4 11.8
Income taxes (0.1) 1.8
Net profit/loss (-) from continuing operations 13.9 (154.5)
Net profit from discontinued operations, net of tax 0.6 1.1
Net profit/loss (-) of the period 14.5 (153.4)
Basic and diluted earnings/loss (-) per share (€) 0.2 (2.3)
Financial investments, cash & cash equivalents 2,982.2 3,297.3

Details of the financial results for the first quarter of 2026

Total operating loss from continuing operations for the first three months of 2026 amounted to €63.7 million, compared to an operating loss of €158.7 million for the first three months of 2025. The operating loss in 2025 was negatively impacted by the executed strategic reorganization announced in January 2025, for €111.0 million. This was mainly reflected in severance costs of €47.5 million, costs for early termination of collaborations of €42.1 million and impairment on fixed assets related to small molecules activities of €10.2 million, professional services costs of €6.6 million and €4.2 million accelerated non-cash cost recognition for subscription right plans.

Total net revenues amounted to €6.5 million for the first three months of 2026, compared to €75.0 million for the first three months of 2025. The revenue recognition related to the exclusive access rights granted to Gilead for Galapagos’ drug discovery platform amounted to €57.6 million for the first three months of 2025. The deferred income related to the drug discovery platform was fully released in revenue at the end of 2025.
Cost of sales amounted to €4.8 million for the first three months of 2026, compared to €13.8 million for the first three months of 2025, and related to the supply of Jyseleca to Alfasigma under the transition agreement. The related revenues are reported in total net revenues.
R&D expenses amounted to €31.0 million for the first three months of 2026, compared to €182.7 million for the first three months of 2025. In the first three months of 2025, the Company recorded increased personnel expenses (mainly related to severance costs), an impairment on fixed assets (related to small molecules programs) and a provision for early termination of collaboration agreements. On top, due to the wind-down of the cell therapy activities the spending in the CAR-T programs decreased in the first three months of 2026 as compared to the first three months of 2025.
S&M and G&A expenses amounted to €35.5 million for the first three months of 2026, compared to €43.8 million for the first three months of 2025. This decrease was mainly due to lower personnel costs (primarily severance costs).
Other operating income amounted to €1.1 million for the first three months of 2026, compared to €6.6 million for the first three months of 2025, mainly driven by lower grant and R&D incentives income.
Net financial income amounted to €77.7 million for the first three months of 2026, compared to net financial income of €2.4 million for the first three months of 2025.

Fair value adjustments and net currency exchange results amounted to a positive amount of €64.3 million for the first three months of 2026, compared to a negative amount of €9.4 million for the first three months of 2025, and were primarily attributable to €40.0 million of positive changes in fair value of financial investments and €23.8 million of unrealized currency exchange gains on our cash and cash equivalents and financial investments at amortized cost in U.S. dollars.
Net other financial income amounted to €13.4 million for the first three months of 2026, compared to net other financial income of €11.8 million for the first three months of 2025. Net interest income amounted to €12.9 million for the first three months of 2026, compared to €12.0 million of net interest income for the first three months of 2025. Fair value gains and interest income derived from cash, cash equivalents and financial investments excluding any currency exchange results amounted to €24.4 million for the first three months of 2026 (compared to €24.9 million for the same period last year).
The Company reported a net profit from continuing operations of €13.9 million for the first three months of 2026, compared to a net loss from its continuing operations of €154.5 million for the first three months of 2025.

Net profit from discontinued operations related to Jyseleca amounted to €0.6 million for the first three months of 2026, compared to net profit amounting to €1.1 million for the first three months of 2025.

Galapagos reported a net profit of €14.5 million for the first three months of 2026, compared to a net loss of €153.4 million for the first three months of 2025.

Cash position
Financial investments and cash and cash equivalents totaled €2,982.2 million on March 31, 2026, as compared to €2,998.0 million on December 31, 2025. The cash and cash equivalents and financial investments included $2,546.4 million held in U.S. dollars ($2,159.0 million on December 31, 2025) which could generate foreign exchange gains or losses in the financial results in accordance with the fluctuation of the EUR/U.S. dollar exchange rate as the Company’s functional currency is EUR (translated at a rate of 1.1498 €/$ at March 31, 2026).

Total net decrease in cash and cash equivalents and financial investments amounted to €15.8 million during the first three months of 2026, compared to a net decrease of €20.5 million during the first three months of 2025. This net decrease was composed of (i) €77.9 million of operational cash burn3, which includes cash in of €16.1 million related to the return on financial investments, (ii) €60.8 million of positive exchange rate differences, positive changes in fair value of current financial investments, variation in accrued interest income, (iii) €1.0 million acquisition of equity investments, and (iv) €2.3 million of net cash in related to the sale of subsidiaries.

Conference call and webcast presentation

Galapagos will host a conference call on May 7, 2026, at 14:00 CET / 08:00 AM ET. To participate, please register using this link. Dial-in details will be provided upon registration. Participants can join the call 10 minutes before the start time using the access information received by email or via the "call me" feature. The live call and presentation will be available on www.glpg.com or via the following link. A replay and related materials will be available shortly after the call in the investors section of the website.

(Press release, Galapagos, MAY 6, 2026, View Source [SID1234665187])

Castle Biosciences Reports First Quarter 2026 Results

On May 6, 2026 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the first quarter ended March 31, 2026.

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"The Castle Biosciences team delivered outstanding results to start 2026, delivering $83.7 million in revenue," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "I thank our team for their dedication and focus, which translates directly to our performance. Our momentum this quarter reflects our robust execution and the strength of our core revenue drivers, with both DecisionDx-Melanoma and TissueCypher achieving double digit year-over-year test volume growth, 16% and 58%, respectively. As a result of our first quarter performance and continued confidence in the business, we are raising our 2026 total revenue guidance to $345-355 million, compared to the previously provided guidance of $340-350 million.

"In addition, during the quarter we expanded the body of evidence supporting our market-leading DecisionDx-Melanoma test. Specifically, we announced new data from a prospective, multicenter, U.S. based study demonstrating that patients with a less than 5% predicted risk of sentinel lymph node positivity had an actual positivity rate of just 2.6%, reinforcing DecisionDx-Melanoma’s ability to guide sentinel lymph node biopsy decision-making in line with guideline thresholds. Our substantial body of evidence is a key driver of adoption and an important differentiator for DecisionDx-Melanoma and our innovative test portfolio more broadly, reinforcing our position of strength as we continue to execute across the business."

First Quarter Ended Mar. 31, 2026, Financial and Operational Highlights
•Revenues were $83.7 million, compared to $88.0 million in the first quarter of 2025. Affecting first quarter 2026 revenue was the change in DecisionDx-SCC Medicare coverage effective April 24, 2025, the re-focus of our commercial efforts, as well as the discontinuation of IDgenetix in May 2025.
◦Revenues for our non-dermatologic tests were $42.6 million, compared to $25.0 million during the same period in 2025.

Core revenue drivers:
•First quarter 2026 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 36% over the first quarter of 2025:
◦DecisionDx-Melanoma test reports delivered in the quarter were 10,021, compared to 8,621 in the first quarter of 2025.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 11,745, compared to 7,432 in the first quarter of 2025.

Additional tests:
◦DecisionDx-SCC test reports delivered in the quarter were 3,702, compared to 4,375 in the first quarter of 2025.
◦MyPath Melanoma test reports delivered in the quarter were 973, compared to 926 in the first quarter of 2025.
◦DecisionDx-UM test reports delivered in the quarter were 492, compared to 470 in the first quarter of 2025.

•Gross margin was 73%, and Adjusted Gross Margin was 76%, compared to 49% and 81%, respectively, for the same periods in 2025. Affecting first quarter 2025 gross margin was the one-time adjustment of an acceleration of amortization expense of approximately $20.1 million.
•Net cash used in operations was $22.1 million, compared to net cash used in operations of $6.0 million for the same period in 2025. First quarter 2026 cash use reflects payout of employee annual cash bonuses as well as certain health care benefit payments, totaling $28.8 million, that are not expected to recur during the remainder of 2026.
•Net loss, which includes non-cash stock-based compensation expense of $9.8 million, was $14.5 million, compared to net loss of $25.8 million for the same period in 2025.
•Net loss per share, Basic and Diluted, was $0.49, compared to net loss per share, Basic and Diluted of $0.90 and Adjusted Net Loss per Share, Basic and Diluted, of $0.20, for the same period in 2025.
•Adjusted EBITDA was $(5.1) million, compared to $13.0 million for the same period in 2025.

Cash, Cash Equivalents and Marketable Investment Securities
As of Mar. 31, 2026, the Company’s cash, cash equivalents and marketable investment securities totaled $261.7 million.
2026 Outlook
Castle Biosciences is raising its guidance for anticipated total revenue in 2026. The Company now anticipates generating between $345-355 million in total revenue in 2026, compared to the previously provided guidance of between $340-350 million.
First Quarter and Recent Accomplishments and Highlights

Dermatology – Skin Cancer
•The Company presented new data at the 2026 American Academy of Dermatology Annual Meeting demonstrating that its DecisionDx-Melanoma test refines mortality risk within American Joint Committee on Cancer (AJCC) stages for patients with cutaneous melanoma (CM). The data showed that DecisionDx-Melanoma identifies clinically meaningful differences in mortality risk among patients within the same stage, which may help clinicians more confidently escalate care for higher-risk patients while avoiding unnecessary interventions in those at lower risk of poor outcomes. See the Company’s news release from March 27, 2026, for more information.
•The Company also announced new data from a prospective, multicenter study evaluating DecisionDx-Melanoma’s integrated sentinel lymph node biopsy (i31-SLNB) test result. The study data confirmed that the i31-SLNB accurately predicts SLN positivity and identifies low-risk patients who may safely consider forgoing SLNB while maintaining favorable long-term outcomes. These results expanded upon earlier publications from the same prospective, multicenter clinical study and further strengthened the growing body of evidence supporting the role of DecisionDx-Melanoma in guiding SLNB decision-making. The paper, available in Future Oncology, confirmed that DecisionDx-Melanoma’s i31-SLNB identifies patients below the 5% National Comprehensive Cancer Network (NCCN) threshold for forgoing sentinel lymph node biopsy and outperforms traditional staging

criteria and other predictive gene expression profile (GEP) tests. See the Company’s news release from March 9, 2026, for more information.
•The Company presented new data at the European Congress of Dermato-Oncology (EADO) Congress and the American College of Mohs Surgery (ACMS) Annual Meeting demonstrating that its DecisionDx-Melanoma test provides independent, personalized prognostic information beyond AJCC staging, identifying biologically high-risk patients—including those with thin and early-stage disease—and supporting more precise, risk-aligned clinical management. See the Company’s news release from April 21, 2026, for more information.
•The Company is supporting a series of initiatives across the country during May in recognition of Skin Cancer Awareness Month, including advocacy walks, community skin cancer screenings and patient education programs in collaboration with leading patient advocacy organizations. These efforts are aimed at expanding access to early detection, education and community-based resources to help prevent skin cancer and improve patient outcomes. See the Company’s news release from May 5, 2026, for more information.
Gastroenterology
•The Company announced that new data from Mayo Clinic researchers, presented at Digestive Disease Week, demonstrate that its TissueCypher test improves risk stratification and informs real-world management decisions for patients with Barrett’s esophagus, including influencing surveillance intervals in more than half of patients and enabling more personalized, risk-aligned care. See the Company’s news release from May 4, 2026, for more information.

Dermatology – Atopic Dermatitis
•The Company announced the publication of a prospective, multicenter clinical validation study in the Journal of the American Academy of Dermatology (JAAD) demonstrating that its AdvanceAD-Tx test can identify patients with moderate-to-severe atopic dermatitis who are significantly more likely to achieve greater and faster clinical responses when treated with a Janus kinase inhibitor compared to T helper type 2-targeted therapies. See the Company’s news release from February 19, 2026, for more information.

Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Wednesday, May 6, 2026, at 4:30 p.m. Eastern time to discuss its first quarter 2026 results and provide a corporate update.
A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until May 27, 2026.
There will be a brief Question & Answer session following management commentary.

(Press release, Castle Biosciences, MAY 6, 2026, View Source [SID1234665186])

Bristol Myers Squibb to Participate in the Bank of America Securities Healthcare Conference 2026

On May 6, 2026 Bristol Myers Squibb (NYSE: BMY) reported that the company will present at the Bank of America Securities Healthcare Conference 2026 on Thursday, May 14, 2026.

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The company will take part in a fireside chat beginning at 8:40 a.m. PT/11:40 a.m. ET.

Investors and the general public are invited to listen to the session by visiting View Source An archived edition of the session will be available following its conclusion.

(Press release, Bristol-Myers Squibb, MAY 6, 2026, View Source [SID1234665185])

BioCryst Reports First Quarter 2026 Financial Results and Provides Business Update

On May 6, 2026 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the quarter ended March 31, 2026, and provided a business update.

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"We began 2026 with continued strong execution across our business, led by sustained growth of ORLADEYO and solid progress across our pipeline," said Charlie Gayer, President and Chief Executive Officer of BioCryst. "ORLADEYO continues to grow because its differentiated oral profile and high level of attack control meet the needs of an increasing number of people living with hereditary angioedema. At the same time, we remain on track with enrollment in our navenibart and BCX17725 pipeline programs. We are also pleased to partner again with Neopharmed Gentili for European rights to navenibart. This progress underscores our strategy to focus on rare diseases where we have deep expertise, execute efficiently, and allocate capital thoughtfully to drive sustainable value for patients and shareholders."

Business & Corporate Updates

New patient prescriptions in Q1 2026 continued to be strong, driving ORLADEYO revenue of $148.3 million (+11% y-o-y; +21% y-o-y on a comparable basis excluding European revenue).
Patient enrollment in ALPHA-ORBIT, the ongoing pivotal study of navenibart in hereditary angioedema, is on track to be completed by the end of this June. The program remains on track to support regulatory filing in the US by the end of 2027. Navenibart is an investigational, long-acting plasma kallikrein inhibitor being studied with every three-month and every six-month subcutaneous dosing.
In May, the company announced that it entered into a licensing agreement with an Irish affiliate of Neopharmed Gentili for exclusive rights to commercialize navenibart in Europe for the prophylaxis of hereditary angioedema. BioCryst will receive upfront consideration of $70M and will be eligible to receive up to $275M in future regulatory and sales milestone payments. BioCryst will also receive tiered royalties on net sales ranging from 18% to 30%. Navenibart is an investigational product that has not yet received regulatory approval in the US or Europe.
The company is studying BCX17725, an investigational KLK5 inhibitor for the treatment of Netherton syndrome, in a Phase 1 trial. The company has begun dosing in Part 4 of this trial, which will enroll up to 12 patients for three months, and expects to report data from this part by the end of 2026.
In Q1 2026, the company ended development of avoralstat, a plasma kallikrein inhibitor for the treatment of diabetic macular edema, to focus the pipeline on rare diseases.
In April, the company appointed Sandeep M. Menon as Chief Research and Development Officer. Dr. Menon brings deep drug development expertise to the leadership team and will lead the company’s R&D efforts with a focused, disciplined, and capital efficient approach.
First Quarter 2026 Financial Results

On January 23, 2026, BioCryst completed the acquisition of Astria Therapeutics, Inc. ("Astria"). The transaction was accounted for as an asset acquisition and as a result, BioCryst recognized a special, non-cash expense of $697.8 million in Q1 2026 related to the acquired in-process research and development asset for navenibart.

The accompanying tables provide GAAP and non-GAAP financial information. Non-GAAP measures include adjustments, as applicable, for the sale of the European ORLADEYO business on October 1, 2025, stock-based compensation, and expenses incurred in connection with the acquisition of Astria, including acquired in-process research and development expense, assembled workforce amortization, severance and retention related costs, and the portion of the Astria stock option payout attributable to post-combination service. Management believes that the presentation of these non-GAAP figures can provide greater transparency into the financial results of core, ongoing operations and improve comparability across reporting periods by excluding items that are non-recurring or other items that may vary significantly from period to period.

BioCryst recorded a GAAP operating loss of $701.6 million for the first quarter of 2026, primarily reflecting the special, non-cash charge related to acquired in-process research and development. On a non-GAAP basis, the company recorded an operating profit of $54.2 million. Additional details on individual adjustments are included in the accompanying financial tables.

Cash, cash equivalents, restricted cash and investments at March 31, 2026, totaled $260.8 million. On a pro-forma basis, including net proceeds of $70 million from the license of European navenibart rights to Neopharmed Gentili after quarter end, cash, cash equivalents, restricted cash and investments at March 31, 2026, totaled $330.8 million.

Financial Outlook for 2026

The company maintained its expectation for full year 2026 global net ORLADEYO revenue to be between $625 million and $645 million and for full year 2026 total revenue, including RAPIVAB (peramivir injection), to be between $635 million and $660 million.

The company also maintained its expectation for full year 2026 non-GAAP operating expenses, excluding stock-based compensation, restructuring, and transaction-related costs, to be between $450 million and $470 million.

Item As of May 6, 2026 As of February 26, 2026
ORLADEYO revenue Unchanged $625 million to $645 million
Total revenue Unchanged $635 million to $660 million
Non-GAAP operating expense Unchanged $450 million to $470 million

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 1-844-481-2942 for domestic callers and 1-412-317-1866 for international callers. A live webcast and replay of the call will be available online in the investors section of the company website at www.biocryst.com.

(Press release, BioCryst Pharmaceuticals, MAY 6, 2026, View Source [SID1234665184])

BeOne Medicines Announces First Quarter 2026 Financial Results and Business Updates

On May 6, 2026 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported financial results and corporate updates from the first quarter of 2026.

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

"These strong first-quarter results reinforce BeOne’s continued growth as a global oncology leader, driven by disciplined commercial execution, and underpinned by our established hematology leadership, and an impressive, rapidly emerging solid tumor pipeline. The sustained competitive advantages of our global superhighway for clinical development and manufacturing are now clear. BRUKINSA has firmly established itself as the foundational, best-in-class BTK inhibitor with unmatched long-term efficacy and safety data for the treatment of CLL and as the only BTKi with proven efficacy superiority over ibrutinib which has resulted in clear global revenue leadership. The fixed-duration combination of sonrotoclax, a foundational, next-generation BCL2 inhibitor, and BRUKINSA represents a potential new standard-of-care in first-line CLL, with BTK CDAC BGB-16673 emerging as a potential first-in-class therapy in the relapsed or refractory setting. With more than 20 abstracts across our hematology and solid tumor pipeline accepted for presentation at ASCO (Free ASCO Whitepaper), BeOne has solidified its position as a leading oncology company."

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

Three Months Ended

March 31,

2026

2025

% Change

Net product revenues

$

1,487,329

$

1,108,530

34

%

Other revenue

$

26,109

$

8,749

198

%

Total revenue

$

1,513,438

$

1,117,279

35

%

GAAP income from operations

$

249,902

$

11,102

2,151

%

Adjusted income from operations*

$

414,394

$

139,357

197

%

GAAP net income

$

227,357

$

1,270

17,802

%

Adjusted net income*

$

375,042

$

136,137

175

%

GAAP basic EPS per ADS

$

2.05

$

0.01

20,400

%

Adjusted basic EPS per ADS*

$

3.38

$

1.27

166

%

GAAP diluted EPS per ADS

$

1.96

$

0.01

19,500

%

Adjusted diluted EPS per ADS*

$

3.24

$

1.22

166

%

Free Cash Flow*

$

160,547

$

(12,325

)

1,403

%

* 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.

First Quarter 2026 Financial Results

Product Revenue totaled $1.5 billion for the first quarter of 2026, representing growth of 34% compared to the prior-year period.

BRUKINSA: Global sales totaled $1.1 billion for the first quarter of 2026, representing growth of 38% compared to the prior-year period; U.S. sales of BRUKINSA totaled $761 million in the first quarter of 2026, representing growth of 35% compared to the prior-year period.
TEVIMBRA (tislelizumab): Global sales totaled $206 million in the first quarter of 2026, representing growth of 20% compared to the prior-year period.
Amgen in-licensed products: Global sales totaled $142 million in the first quarter of 2026, representing growth of 25% compared to the prior-year period.
Gross Margin as a percentage of global product sales for the first quarter of 2026 was 89%, compared to 85% 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 our 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 first quarter of 2026:

GAAP

Non-GAAP

(unaudited, in thousands, except percentages)

Q1 2026

Q1 2025

% Change

Q1 2026

Q1 2025

% Change

Research and development

$

541,224

$

481,887

12

%

$

465,904

$

421,195

11

%

Selling, general and administrative

$

555,097

$

459,288

21

%

$

471,993

$

395,511

19

%

Total operating expenses

$

1,096,321

$

941,175

16

%

$

937,897

$

816,706

15

%

Research and Development (R&D) Expenses increased for the first quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to advancing preclinical programs into the clinic and early clinical programs into late stage.

Selling, General and Administrative (SG&A) Expenses increased for the first 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 37% for the first quarter of 2026, compared to 41% in the prior-year period.

Net Income and Basic/Diluted Earnings Per Share

GAAP net income for the first quarter of 2026 was $227 million, an increase of $226 million over the prior-year period, primarily attributable to revenue growth and improved operating leverage.

For the first quarter of 2026, basic and diluted earnings per share were $0.16 and $0.15 per share and $2.05 and $1.96 per American Depositary Share (ADS), compared to basic and diluted earnings per share of $0.00 per share and $0.01 per ADS in the prior-year period.

Free Cash Flow for the first quarter of 2026 was $161 million, representing an increase of $173 million over the prior-year period.

For further details on BeOne’s First Quarter 2026 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the first 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

$6.2 – $6.4 billion

$6.3 – $6.5 billion

GAAP gross margin %

High-80% range

High-80% range

GAAP operating expenses2

(combined R&D and SG&A)

$4.7 – $4.9 billion

$4.7 – $4.9 billion

GAAP operating income2

$700 – $800 million

$750 – $850 million

Non-GAAP operating income2,3

$1.4 – $1.5 billion

$1.45 – $1.55 billion

1 Assumes May 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 $6.3 billion to $6.5 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 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. See Form 10-Q for additional updates on income tax uncertainties.
Diluted ADS outstanding: The Company expects diluted ADSs outstanding of approximately 118 million.
First Quarter 2026 Business Highlights

Core Marketed Products

BRUKINSA (zanubrutinib)

Received Orphan Drug Designation in Japan for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL).
Submitted New Drug Application in Japan for R/R MZL and tablet formulation.
Sonrotoclax (BCL2 inhibitor)

Launched and commercially available in China for the treatment of adult patients with R/R mantle cell lymphoma (MCL) and R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Included in the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) guidelines as a recommended third-line treatment for R/R MCL patients.
TEVIMBRA (tislelizumab)

Received acceptance of a Supplemental Biologics License Application (sBLA) by the U.S. Food and Drug Administration (FDA) with Priority Review for the treatment of adult patients with first-line HER2-positive gastroesophageal adenocarcinoma (GEA) in combination with ZIIHERA (zanidatamab) and chemotherapy, based on results of the HERIZON-GEA-01 trial which demonstrated statistically significant and clinically meaningful improvement in overall survival versus trastuzumab plus chemotherapy.
Received acceptance of sBLA by the Center for Drug Evaluation (CDE) in China for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA and chemotherapy.
ZIIHERA (zanidatamab)

Received acceptance of sBLA by the CDE in China for the treatment of adult patients with first-line HER2-positive GEA in combination with chemotherapy, with or without TEVIMBRA.
Select Clinical-Stage Programs

Hematology

BGB-16673 (BTK CDAC): Initiated Phase 2 cohorts in R/R MZL and Richter’s Transformation.
Breast and Gynecological Cancers

BGB-43395 (CDK4 inhibitor): Received acceptance of Phase 1 study data as a poster presentation at ASCO (Free ASCO Whitepaper).
BG-C9074 (B7-H4 ADC): Received acceptance of Phase 1 study data as a rapid oral presentation at ASCO (Free ASCO Whitepaper).
Gastrointestinal Cancers

BGB-B2033 (GPC3x41BB bispecific antibody):
Received FDA Orphan Drug Designation for hepatocellular carcinoma (HCC).
Initiated potentially registrational study in patients with HCC.
Received acceptance of Phase 1 study data as a rapid oral presentation at ASCO (Free ASCO Whitepaper).
Lung Cancer

BG-C0979 (ADAM9-targeting ADC): Initiated first-in-human study.
Inflammation and Immunology

BG-A3004 (KLRG1 mAb): Initiated first-in-human study.
Anticipated R&D Milestones

Programs

Milestones
Timing

BRUKINSA

•

Interim analysis in the Phase 3 MANGROVE study data in combination with rituximab versus bendamustine plus rituximab for the treatment of adult patients with first-line MCL.
1H 2026

•

Japan regulatory action for the treatment of adult patients with first-line gastric cancer.
1H 2026

•

U.S. FDA regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA.
2H 2026

TEVIMBRA

•

China regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA.
1H 2027

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 study 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

•

BGB-43395 (CDK4 inhibitor):
Cancers

◦

Phase 3 study initiation for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer.

1H 2026

Lung Cancer

•

BON-110 (PD-1xVEGF-AxCTLA-4 trispecific antibody):

First-in-human study initiation.

1H 2026

Gastrointestinal

•

BGB-B2033 (GPC3x41BB bispecific antibody):

Cancers

◦

Pivotal Phase 3 study initiation.

2H 2026

Inflammation and

•

BGB-16673 (BTK CDAC):
Immunology

Phase 2 study initiation for the treatment of adult patients with chronic spontaneous urticaria.

2H 2026

Corporate Updates

Entered into an exclusive option with Huahui Health to license worldwide rights to HH160 (BON-110), a novel trispecific antibody targeting PD-1, VEGF-A and CTLA-4.
BeOne’s Earnings Results Webcast

The Company’s earnings conference call for the first quarter 2026 will be broadcast via webcast at 8:00 a.m. ET on Wednesday, May 6, 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, MAY 6, 2026, View Source [SID1234665183])