On May 7, 2025 BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that will change its name to BeOne Medicines, Ltd., reported financial results and corporate updates from the first quarter 2025 (Press release, BeiGene, MAY 7, 2025, View Source [SID1234652634]).
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"We delivered another exceptional quarter, achieving our first quarter of GAAP profitability with continued global revenue growth. In the U.S., BRUKINSA remains the leader in new chronic lymphocytic leukemia (CLL) patient starts across all lines of therapy, and for the first time has become the overall BTKi market share leader," said John V. Oyler, Co-Founder, Chairman, and CEO of BeiGene. "We’ve made significant strides across our late-stage hematology and solid tumor pipelines, with multiple proof-of-concept readouts expected this year across our broad portfolio of antibody-drug conjugates, multispecific antibodies and targeted protein degraders. With accelerating financial momentum and a diversified global footprint spanning six continents, we are well positioned — as we transition to BeOne Medicines and redomicile to Switzerland — to become one of the world’s most impactful oncology innovators."
First Quarter 2025 Financial Snapshot
(Amounts in thousands of U.S. dollars and unaudited)
Three Months Ended March 31,
2025 2024 % Change
Net product revenues $ 1,108,530 $ 746,918 48 %
Net revenue from collaborations $ 8,749 $ 4,734 85 %
Total revenue $ 1,117,279 $ 751,652 49 %
GAAP income (loss) from operations $ 11,102 $ (261,348) 104 %
Adjusted income (loss) from operations* $ 139,357 $ (147,341) 195 %
GAAP net income (loss) $ 1,270 $ (251,150) 101 %
Adjusted net income (loss)* $ 136,137 $ (145,896) 193 %
GAAP basic EPS per ADS $ 0.01 $ (2.41) 100 %
Adjusted basic EPS per ADS* $ 1.27 $ (1.40) 191 %
GAAP diluted EPS per ADS $ 0.01 $ (2.41) 100 %
Adjusted diluted EPS per ADS* $ 1.22 $ (1.40) 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.
First Quarter 2025 Financial Results
Revenue for the first quarter of 2025 was $1.1 billion, compared to $752 million in the prior-year period driven primarily by growth in BRUKINSA product sales in the U.S. and Europe.
Product Revenue totaled $1.1 billion for the first quarter of 2025 compared to $747 million in the prior-year period. The increase in product revenue was primarily attributable to increased sales of BRUKINSA. The U.S. continued to be the Company’s largest market, with product revenue of $563 million compared to $351 million in the prior-year period. In-licensed products from Amgen and TEVIMBRA also contributed to product revenue growth.
•U.S. sales of BRUKINSA totaled $563 million in the first quarter of 2025, representing growth of 60% over the prior-year period driven primarily by demand, with more than 60% of the quarter-over-quarter growth coming from expanded use in CLL as BRUKINSA continued to gain share as the leader in new patient starts in the U.S. in CLL and all other approved indications; BRUKINSA sales in Europe totaled $116 million in the first quarter of 2025, representing growth of 73% compared to the prior-year period, driven by increased market share across all major European markets, including Germany, Italy, Spain, France and the UK.
•Sales of TEVIMBRA totaled $171 million in the first quarter of 2025, representing growth of 18% compared to the prior-year period.
Gross Margin as a percentage of global product sales for the first quarter of 2025 was 85.1% compared to 83.3% 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 margins also benefited from cost of sales productivity improvements for both BRUKINSA and TEVIMBRA. On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of product sales increased to 85.5% for the first quarter of 2025, compared to 83.7% in the prior-year period.
Operating Expenses
The following table summarizes operating expenses for the first quarter of 2025:
GAAP Non-GAAP
(unaudited, in thousands, except percentages) Q1 2025 Q1 2024 % Change Q1 2025 Q1 2024 % Change
Research and development $ 481,887 $ 460,638 5 % $ 421,195 $ 405,440 4 %
Selling, general and administrative $ 459,288 $ 427,427 7 % $ 395,511 $ 372,146 6 %
Total operating expenses $ 941,175 $ 888,065 6 % $ 816,706 $ 777,586 5 %
Research and Development (R&D) Expenses increased for the first quarter of 2025 compared to the prior-year period on both a GAAP and adjusted basis primarily due to advancing preclinical programs into the clinic and early clinical programs into late stage. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled nil and $35 million in the first quarter of 2025 and 2024, respectively.
Selling, General and Administrative (SG&A) Expenses increased for the first quarter of 2025 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment in the global commercial expansion of BRUKINSA primarily in the U.S. and Europe. SG&A expenses as a percentage of product sales were 41% for the first quarter of 2025, compared to 57% in the prior-year period.
Net Income/(Loss) and Earnings Per Share
GAAP net income improved for the first quarter of 2025, as compared to the prior-year period loss, primarily attributable to revenue growth and improved operating leverage.
For the first quarter of 2025, both basic and diluted earnings per share was $0.00 per share and $0.01 per American Depositary Share (ADS), respectively, compared to basic loss of $0.19 per share and $2.41 per ADS in the prior-year period.
Cash Provided by Operations for the first quarter of 2025 was $44 million, an increase of $353 million over the prior-year period.
For further details on BeiGene’s First Quarter 2025 Financial Statements, please see BeiGene’s Quarterly Report on Form 10-Q for the first quarter of 2025 filed with the U.S. Securities and Exchange Commission.
Full Year 2025 Guidance
BeiGene is maintaining its full year 2025 revenue and expense guidance. Guidance is summarized below:
FY 20251
Total Revenue $4.9 billion to $5.3 billion
GAAP Operating Expenses (R&D and SG&A) $4.1 billion to $4.4 billion
Additional: GAAP Gross Margin Percentage in mid-80% range
Positive Full Year GAAP Operating Income
Generation of Positive Cash Flow from Operations
1 Does not assume any potential new, material business development activity or unusual/non-recurring items. Assumes January 31, 2025 foreign exchange rates.
BeiGene’s total revenue guidance for full year 2025 of $4.9 billion to $5.3 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 mid-80% range due to mix and production efficiencies as compared to 2024. BeiGene’s 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. Non-GAAP operating expenses, which exclude costs related to share-based compensation, depreciation and amortization expense, are expected to track with GAAP operating expenses, with reconciling items unchanged from existing practice. Operating expense guidance does not assume any potential new, material business development activity or unusual/non-recurring items.
First Quarter Business Highlights
Core Marketed Products
BRUKINSA
•BRUKINSA is now approved in 75 markets globally with 11 new or expanded reimbursements in the quarter, including in Japan, Europe and Brazil.
•Received approval for the addition of Siegfried in Switzerland as an alternate Drug Substance manufacturer by the European Medicines Agency.
TEVIMBRA
•TEVIMBRA is now approved in 46 markets globally with 11 new reimbursements in the quarter, including in the U.S., Europe and China.
•Received U.S. Food and Drug Administration (FDA) approval in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1).
•Received FDA approval for 150 mg Q2W and 300 mg Q4W alternate dosing regimens in addition to the already approved 200 mg Q3W dosing.
•Received Japan approval in combination with platinum-containing chemotherapy for the first- and second-line treatment of adult patients with unresectable or metastatic ESCC.
•Received European Commission approval in combination with etoposide and platinum chemotherapy as a first-line treatment for adult patients with extensive-stage small cell lung cancer.
Select Clinical-Stage Programs
Hematology
•Sonrotoclax (BCL2 inhibitor): Continued enrollment of global Phase 2 trial for the treatment of Waldenström’s macroglobulinemia.
•Sonrotoclax BGB-11417-202: Filed in China for the treatment of relapsed/refractory (R/R) CLL.
•Sonrotoclax CELESTIAL-RR MCL BGB-11417-302: Achieved first subject enrolled for Phase 3 trial for the treatment of R/R MCL.
•Sonrotoclax CELESTIAL-TN CLL BGB-11417-301: Achieved last subject enrolled for Phase 3 trial for the treatment of treatment-naïve (TN) CLL.
•BGB-16673 (BTK CDAC): Continued enrollment of potentially registration enabling Phase 2 trial for the treatment of R/R CLL with data readout expected in 2026.
•BGB-16673: Initiated Phase 3 trial compared to physician’s choice (IR/VR/BR) for treatment of R/R CLL.
Lung Cancer
•Tarlatamab (AMG757, DLL3xCD3 BiTE): Announced positive data readout from Phase 3 trial for the treatment of second-line small cell lung cancer in collaboration with Amgen.
•Anti-TIGIT antibody: Discontinued clinical development of ociperlimab as a potential treatment for lung cancer.
Anticipated R&D Milestones
•The Company will hold an Investor R&D Day on June 26 highlighting its emerging breast cancer franchise and broader solid tumor portfolio.
Programs
Milestones
Timing
BRUKINSA
•Tablet formulation: FDA and European Commission approvals.
2H 2025
•MANGROVE trial for TN MCL: Interim analysis of Phase 3 trial.
2H 2025
•MAHOGANY trial for the treatment of R/R follicular lymphoma: Complete enrollment of the FL portion of Phase 3 trial.
2H 2025
TEVIMBRA
•EU approvals for the treatment of:
◦Neoadjuvant/adjuvant non-small cell lung cancer.
1H 2025
◦First-line nasopharyngeal carcinoma.
2H 2025
•Subcutaneous formulation: Initiate Phase 3 trial.
2H 2025
Hematology
•Sonrotoclax in combination with anti-CD20 antibody for the treatment of R/R CLL: First subject enrolled in global Phase 3 trial.
1H 2025
•Sonrotoclax for the treatment of R/R MCL: Data readout of Phase 2 trial and potential global accelerated approval submissions.
2H 2025
•BGB-16673 compared to noncovalent BTK inhibitor pirtobrutinib for the treatment of R/R CLL: Initiate Phase 3 head-to-head trial.
2H 2025
Lung Cancer
•BGB-58067 (PRMT5 inhibitor) and BG-89894 (MAT2A inhibitor): First subject enrolled in combination trial.
2H 2025
Breast and Gynecologic Cancers
•BGB-43395 (CDK4 inhibitor): Proof-of-concept data.
1H 2025
GI Cancers
•Zanidatamab (HER2-bispecific antibody) for the treatment of first-line HER2-positive gastroesophageal adenocarcinoma: Readout of primary progression-free survival data from Phase 3 trial of in collaboration with Zymeworks/Jazz.
2H 2025
Inflammation and Immunology
•BGB-45035 (IRAK4 CDAC): First subject enrolled in Phase 2 trial.
2H 2025
•BGB-45035: Proof-of-concept data for tissue IRAK4 degradation.
2H 2025
Other Highlights
•Received shareholder approval on April 28, 2025, to rename the Company to BeOne Medicines Ltd. and redomicile to Switzerland with the transaction set to close later this year.
•As previously disclosed, announced a U.S. Patent Trademark Office Final Written Decision invalidating all claims of Pharmacyclics LLC’s U.S. Patent No. 11,672,803 that were challenged by BeiGene in a post-grant review (PGR) proceeding.
•Appointed Marcello Damiani as Chief Technology Officer.
Conference Call and Webcast
The Company’s earnings conference call for the first quarter 2025 will be broadcast via webcast at 8:00 a.m. ET on Wednesday, May 7, 2025, and will be accessible through the Investors section of BeiGene’s website, www.beigene.com. Supplemental information in the form of a slide presentation and a replay of the webcast will also be available.