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Business Upturn
28-05-2025
- Business
- Business Upturn
BeOne Medicines Launches Following Redomiciliation to Switzerland, Marking a New Chapter in Global Oncology
Basel, Switzerland & San Carlos, Calif., United States: BeOne well-positioned to deliver transformative treatments to patients worldwide with powerful oncology portfolio, pioneering clinical development approach, and expanded global manufacturing and commercial capabilities Redomiciliation to Switzerland bolsters Company's presence in leading global biopharmaceutical hub, marks next step in becoming a diversified biotechnology company focused on oncology BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company formerly known as BeiGene, Ltd., today announced its new name and redomiciliation to Switzerland are officially in effect, marking a significant milestone in the Company's evolution. This press release features multimedia. View the full release here: BeOne Medicines' biologics manufacturing facility and clinical R&D center in Hopewell, NJ. 'BeOne represents more than a name change—it's not only a reflection of who we are today as a leading global oncology company, but also our ambition to redefine what's possible in oncology as we unite patients, families, scientists, physicians, governments, and other oncology public health stakeholders around the world in our shared mission against cancer,' said John V. Oyler, Co-Founder, Chairman and CEO at BeOne. 'While I know that our work is not done, I am extremely proud of the progress we have made with the explosive growth of BRUKINSA as the backbone of our hematology franchise, the expansion of our PD-1 inhibitor, TEVIMBRA, and our potentially transformative oncology pipeline of more than 50 investigational assets, one of the most prolific in the industry. After 15 years of relentless innovation and strategic investment to boost our internal global capabilities, we are just getting started, and I look forward to working together as BeOne.' The new name and redomiciliation to Switzerland from the Cayman Islands were approved by shareholders on April 28. The transition to the BeOne name across the Company's worldwide operations on six continents will happen in phases. The redomiciliation to Switzerland strengthens BeOne's presence and deepens its roots in a global biopharmaceutical hub, further enabling its growth strategy of bringing innovative medicines to patients around the world. Industry-Leading Innovation and Global Scale BeOne has built a differentiated and sustainable advantage through strategic investments to bolster its internal research, clinical development, and manufacturing capabilities. This unique model harnesses time and cost efficiencies to improve patient access, enables close oversight to enforce high standards across R&D and manufacturing, and safeguards our operational resilience for long-term growth. BRUKINSA has the broadest label in its treatment class and leads in new patient starts across all of its approved indications in the U.S. It also is the cornerstone of BeOne's hematology franchise as a foundational treatment alongside late-stage BCL2 inhibitor sonrotoclax and potential first-in-class BTK protein degrader, BGB-16673, which was developed from the Company's proprietary CDAC platform. BeOne also is focused on building future solid tumor franchises in breast, lung, and gastrointestinal cancers. By leveraging its platforms in multi-specific antibodies, protein degraders and antibody-drug conjugates, the Company is positioned to transform the future of oncology treatment. BeOne's entrepreneurial research team, comprising more than 1,100 colleagues, advanced 13 new molecular entities into the clinic in 2024 alone, outpacing even the largest pharmaceutical companies. Further, its nearly 3,700-strong clinical development team has active or planned trials across more than 45 countries and regions, accelerating early-stage innovation through its 'Fast to Proof-of-Concept' approach. To date, the Company has enrolled more than 25,000 patients in more than 170 trials, delivering speed and cost advantages that set it apart from industry peers. In addition, BeOne continues to expand its global manufacturing network with its $800 million flagship clinical R&D and manufacturing facility at the Princeton West Innovation Campus in Hopewell, N.J. This state-of-the-art site enables scalable production capacity to support the Company's rapidly growing pipeline, operational resilience, and global ambitions. About BeOne BeOne Medicines, formerly known as BeiGene, is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn , X , Facebook and Instagram . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeOne's ability to deliver transformative treatments to patients worldwide; the potential and future success of BeOne's oncology pipeline; BeOne's presence in Switzerland and its ability to enable further growth; the sustainable advantage of BeOne's strategic investments and its ability to improve patient access; the future long-term growth of the Company; BeOne's ability to transform the future of oncology treatment; and BeOne's plans, commitments, aspirations and goals under the caption 'About BeOne'. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne's ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our Newsroom . View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same.
Business Wire
27-05-2025
- Business
- Business Wire
BeOne Medicines Launches Following Redomiciliation to Switzerland, Marking a New Chapter in Global Oncology
SAN CARLOS, Calif. & BASEL, Switzerland--(BUSINESS WIRE)-- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company formerly known as BeiGene, Ltd., today announced its new name and redomiciliation to Switzerland are officially in effect, marking a significant milestone in the Company's evolution. 'BeOne represents more than a name change—it's not only a reflection of who we are today as a leading global oncology company, but also our ambition to redefine what's possible in oncology as we unite patients, families, scientists, physicians, governments, and other oncology public health stakeholders around the world in our shared mission against cancer,' said John V. Oyler, Co-Founder, Chairman and CEO at BeOne. 'While I know that our work is not done, I am extremely proud of the progress we have made with the explosive growth of BRUKINSA as the backbone of our hematology franchise, the expansion of our PD-1 inhibitor, TEVIMBRA, and our potentially transformative oncology pipeline of more than 50 investigational assets, one of the most prolific in the industry. After 15 years of relentless innovation and strategic investment to boost our internal global capabilities, we are just getting started, and I look forward to working together as BeOne.' The new name and redomiciliation to Switzerland from the Cayman Islands were approved by shareholders on April 28. The transition to the BeOne name across the Company's worldwide operations on six continents will happen in phases. The redomiciliation to Switzerland strengthens BeOne's presence and deepens its roots in a global biopharmaceutical hub, further enabling its growth strategy of bringing innovative medicines to patients around the world. Industry-Leading Innovation and Global Scale BeOne has built a differentiated and sustainable advantage through strategic investments to bolster its internal research, clinical development, and manufacturing capabilities. This unique model harnesses time and cost efficiencies to improve patient access, enables close oversight to enforce high standards across R&D and manufacturing, and safeguards our operational resilience for long-term growth. BRUKINSA has the broadest label in its treatment class and leads in new patient starts across all of its approved indications in the U.S. It also is the cornerstone of BeOne's hematology franchise as a foundational treatment alongside late-stage BCL2 inhibitor sonrotoclax and potential first-in-class BTK protein degrader, BGB-16673, which was developed from the Company's proprietary CDAC platform. BeOne also is focused on building future solid tumor franchises in breast, lung, and gastrointestinal cancers. By leveraging its platforms in multi-specific antibodies, protein degraders and antibody-drug conjugates, the Company is positioned to transform the future of oncology treatment. BeOne's entrepreneurial research team, comprising more than 1,100 colleagues, advanced 13 new molecular entities into the clinic in 2024 alone, outpacing even the largest pharmaceutical companies. Further, its nearly 3,700-strong clinical development team has active or planned trials across more than 45 countries and regions, accelerating early-stage innovation through its 'Fast to Proof-of-Concept' approach. To date, the Company has enrolled more than 25,000 patients in more than 170 trials, delivering speed and cost advantages that set it apart from industry peers. In addition, BeOne continues to expand its global manufacturing network with its $800 million flagship clinical R&D and manufacturing facility at the Princeton West Innovation Campus in Hopewell, N.J. This state-of-the-art site enables scalable production capacity to support the Company's rapidly growing pipeline, operational resilience, and global ambitions. About BeOne BeOne Medicines, formerly known as BeiGene, is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeOne's ability to deliver transformative treatments to patients worldwide; the potential and future success of BeOne's oncology pipeline; BeOne's presence in Switzerland and its ability to enable further growth; the sustainable advantage of BeOne's strategic investments and its ability to improve patient access; the future long-term growth of the Company; BeOne's ability to transform the future of oncology treatment; and BeOne's plans, commitments, aspirations and goals under the caption 'About BeOne'. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne's ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our Newsroom.
Business Wire
27-05-2025
- Business
- Business Wire
BeiGene Receives Positive CHMP Opinion for TEVIMBRA ® as a First-Line Treatment for Nasopharyngeal Cancer
SAN CARLOS, Calif.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that will change its name to BeOne Medicines Ltd., today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of TEVIMBRA ® (tislelizumab), in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic NPC. 'Chemotherapy has been the standard treatment for metastatic NPC; however, distant metastasis continues to be a significant cause of treatment failure and death, making new treatment options essential,' said Prof. Lisa Licitra, Chief of Head and Neck Cancer Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. 'Results from the RATIONALE-309 study support the robust clinical benefit of TEVIMBRA plus chemotherapy, which has the potential to significantly reduce the risk of disease progression or death for patients with recurrent or metastatic NPC. ' The extension of indication for NPC is based on results from BeiGene's RATIONALE-309 (NCT03924986), a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate the efficacy and safety of TEVIMBRA, in combination with gemcitabine plus cisplatin, as first-line treatment in adult patients with recurrent or metastatic NPC. At the time of the prespecified interim analysis, the study, which randomized 263 treatment-naïve patients, met its primary endpoint, significantly prolonging progression-free survival (PFS) in the intent-to-treat (ITT) population (HR 0.52 [95% CI:0.38, 0.73] p<0.0001). The median PFS in the TEVIMBRA with chemotherapy arm was 9.2 months compared to 7.4 months in the placebo with chemotherapy arm. An updated analysis showed consistent efficacy results with the interim analysis. The median overall survival (OS) was 45.3 months for TEVIMBRA plus chemotherapy versus 31.8 months for placebo plus chemotherapy. TEVIMBRA plus chemotherapy was generally well tolerated, with no new safety signals identified. 'Today's announcement marks a second positive CHMP opinion for TEVIMBRA in 2025, signifying the potential to expand into yet another disease area in the European Union and to support even more patients living with cancer,' said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. 'As the foundation of our solid tumor portfolio, we are encouraged by TEVIMBRA's momentum in achieving more than 100 regulatory approvals for a range of cancer indications across the world, including major markets such as the US, the EU, China, and Japan, demonstrating the strength of evidence across a range of indications.' The pooled safety data in this extension of indication included more than 3,900 patients who received TEVIMBRA as either monotherapy (n=1,952) or in combination with chemotherapy (n=1,950) at the approved dosing regimen. The most common Grade 3 or 4 adverse reactions (≥ 2%) for TEVIMBRA given in combination with chemotherapy were neutropenia, anemia, thrombocytopenia, hyponatremia, hypokalemia, fatigue, pneumonia, lymphopenia, rash, decreased appetite, increased aspartate aminotransferase, and increased alanine aminotransferase. TEVIMBRA is currently approved in the EU as a first-line treatment for eligible patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, as a first-line treatment for unresectable esophageal squamous cell carcinoma (ESCC), as a second-line treatment in ESCC after prior platinum-based chemotherapy, as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) in combination with chemotherapy, and for three non-small lung cancer (NSCLC) indications covering both the first- and second-line settings. About Nasopharyngeal Cancer (NPC) Nasopharyngeal cancer is a type of head and neck cancer that starts in the nasopharynx, 1 the upper throat passage that connects the nose to the lungs. 2 NPC is often diagnosed at advanced stages due to its deep anatomical location and mild early symptoms, making early detection challenging. 3 Globally, NPC accounts for approximately 133,000 new cancer cases and 80,000 deaths per year and exhibits a unique geographical pattern, with its prevalence notably concentrated in Asia. 4 While the overall 5-year survival rate for NPC is approximately 63%, in advanced disease the survival rate decreases to 49%. 5 About TEVIMBRA (Tislelizumab) TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1(PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body's immune cells to detect and fight tumors. TEVIMBRA is the foundational asset of BeiGene's solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 21 registration-enabling studies. TEVIMBRA is approved in 46 countries, and more than 1.5 million patients have been treated globally. Important Safety Information The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency. This information is intended for a global audience. Product indications vary by region. About BeiGene BeiGene, which will change its name to BeOne Medicines Ltd., is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeiGene, please visit Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the ability of TEVIMBRA plus chemotherapy to significantly reduce the risk of disease progression or death for patients with recurrent or metastatic NPC; the ability of BeiGene to support even more patients living with cancer;; and BeiGene's plans, commitments, aspirations, and goals under the heading 'About BeiGene.' Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeiGene's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law. To access BeiGene media resources, please visit our News & Media site.
Business Wire
07-05-2025
- Business
- Business Wire
BeiGene Announces First Quarter 2025 Financial Results and Business Updates
SAN CARLOS, Calif.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that will change its name to BeOne Medicines, Ltd., today announced financial results and corporate updates from the first quarter 2025. '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) * 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: 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: 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. 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 Expand 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, Supplemental information in the form of a slide presentation and a replay of the webcast will also be available. About BeiGene BeiGene, which will change its name to BeOne Medicines Ltd., is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the anticipated milestones to be achieved by BeiGene in 2025; BeiGene's ability to become one of the world's most impactful oncology innovators; BeiGene's future revenue, operating income, cash flow, operating expenses and gross margin percentage; and BeiGene's plans, commitments, aspirations and goals under the caption 'About BeiGene'. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene's ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeiGene's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law. BeiGene's financial guidance is based on estimates and assumptions that are subject to significant uncertainties. Select Condensed Consolidated Balance Sheet Data (U.S. GAAP) (Amounts in thousands of U.S. Dollars) As of March 31, December 31, 2025 2024 (unaudited) (audited) Assets: Cash, cash equivalents and restricted cash $2,530,591 $2,638,747 Accounts receivable, net 717,239 676,278 Inventories 494,660 494,986 Property, plant and equipment, net 1,598,588 1,578,423 Total assets 5,841,526 5,920,910 Liabilities and equity: Accounts payable 364,498 404,997 Accrued expenses and other payables 692,179 803,713 R&D cost share liability 145,628 165,440 Debt 923,627 1,018,013 Total liabilities 2,342,013 2,588,688 Total equity $3,499,513 $3,332,222 Expand Note Regarding Use of Non-GAAP Financial Measures BeiGene provides certain non-GAAP financial measures, including Adjusted Operating Expenses Adjusted Operating Loss, Adjusted Net Income, Adjusted Earnings Per Share and certain other non-GAAP income statement line items, each of which include adjustments to GAAP figures. These non-GAAP financial measures are intended to provide additional information on BeiGene's operating performance. Adjustments to BeiGene's GAAP figures exclude, as applicable, non-cash items such as share-based compensation, depreciation and amortization. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred. Non-GAAP adjustments are tax effected to the extent there is US GAAP current tax expense. The Company currently records a valuation allowance on its net deferred tax assets, so there is no net impact recorded for deferred tax effects. BeiGene maintains an established non-GAAP policy that guides the determination of what costs will be excluded in non-GAAP financial measures and the related protocols, controls and approval with respect to the use of such measures. BeiGene believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of BeiGene's operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of the Company's historical and expected financial results and trends and to facilitate comparisons between periods and with respect to projected information. In addition, these non-GAAP financial measures are among the indicators BeiGene's management uses for planning and forecasting purposes and measuring the Company's performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. *Tax effect of Non-GAAP adjustments is based on the statutory tax rate in the relevant tax jurisdiction. Please note that the Company currently records a valuation allowance on its net deferred tax assets, so there is no net impact recorded for deferred tax effects.
Yahoo
05-04-2025
- Business
- Yahoo
BeiGene (NasdaqGS:ONC) Gains 32% In A Quarter Amid Positive EMA Opinion On TEVIMBRA
BeiGene has climbed 32% over the past quarter, against a backdrop of significant industry challenges and broad market declines. The company's positive momentum can be attributed to the European Medicines Agency's positive opinion on TEVIMBRA, recommended for small cell lung cancer treatment, and its recent addition to the Hang Seng China Enterprises Index. These developments underscore BeiGene's expanding presence and potential in the competitive oncology market, providing a counter-narrative to the broader market, which suffered notable downturns due to tariff turmoil and escalating trade tensions between major global economies. Buy, Hold or Sell BeiGene? View our complete analysis and fair value estimate and you decide. The end of cancer? These 21 emerging AI stocks are developing tech that will allow early idenification of life changing disesaes like cancer and Alzheimer's. Over the past year, BeiGene has experienced an impressive total shareholder return of 58.97%, significantly outperforming both the US Biotechs industry, which saw a 10.4% decline, and the broader US Market, which grew by 3.3%. A key driver of this strong performance was the FDA approval of TEVIMBRA for treating esophageal squamous cell carcinoma in March 2025, followed by inclusion in the Hang Seng China Enterprises Index shortly after. These developments have strengthened BeiGene's market position and credibility. Further bolstering the company's upward trajectory was its financial performance for the year ending December 2024, which saw a revenue increase to US$3.81 billion from US$2.46 billion the previous year, alongside a reduction in net losses. Additionally, the strategic collaboration announced with ImmunityBio, Inc. in January 2025 to conduct Phase 3 trials may position BeiGene for future pipeline advancements. Evaluate BeiGene's prospects by accessing our earnings growth report. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NasdaqGS:ONC. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
