BeOne Medicines Ltd.

BeOne Medicines Ltd. operates in the global oncology pharmaceutical industry, discovering and developing innovative treatments for cancer patients worldwide. The company is a serial innovator in hematology and has built a differentiated, wholly-owned, and foundational franchise, being the only company with potentially best-in-class assets across three foundational chronic lymphocytic leukemia mechanisms of action. The company is built to address long-lived challenges to return on investment in the pharmaceutical industry, noting that clinical trials represent more than 75% of the total cost of bringing an oncology medicine to patients, yet the industry continues to outsource this function to contract research organizations at an ever-increasing cost per patient. Regulatory policies such as Project Optimus lead to meaningful program delays and increasing Phase 1 trial costs due to increased patient requirements and time, and pricing reform, such as the Inflation Reduction Act in the U.S., is placing direct and indirect pressure on innovators.

Primary competitors named in the filing include AbbVie & Janssen (IMBRUVICA), AstraZeneca (CALQUENCE), Eli Lilly (JAYPIRCA), and Innocare (YINUOKAI) for BRUKINSA; Merck (KEYTRUDA), Bristol Myers Squibb (OPDIVO), AstraZeneca (IMFINZI), Roche (TECENTRIQ), Merck KGaA (BAVENCIO), Regeneron & Sanofi (LIBTAYO), GSK (JEMPERLI), Junshi (LOQTORZI), Henlius (HANSIZHUANG), and various Chinese companies for TEVIMBRA; and AbbVie & Roche (VENCLEXTA) and Ascentage Pharma (Lisaftoclax) for sonrotoclax. Despite being the third entrant to the market, BRUKINSA became the global market leader across B-cell malignancies in 2025. The company's global development 'superhighway' is described as unique to BeOne and critical to generating superior returns on R&D investment, with independence from traditional CRO models allowing more cost-efficient development and faster time to clinical proof-of-concept.

The company generates revenue primarily through product sales of its internally developed and in-licensed cancer medicines, as well as collaboration revenue. In 2025, total global revenue was approximately $5.3 billion ¹, increasing by approximately 40.2% ² from the prior year. The business model is described as sustainable, resulting in a strong global financial profile. The company has built a global commercial organization to deliver medicines to patients around the globe, with established commercial capabilities in key large commercial markets of the U.S., EU, and China, and continued rapid expansion into the Asia Pacific, Latin America, and Middle East regions. The company's nearly 6,000 colleagues across clinical development and manufacturing globally allow it to break from the traditional CRO model and develop medicines with greater speed and at a lower cost.

BRUKINSA is a next-generation, oral, small molecule inhibitor of Bruton's tyrosine kinase designed to deliver complete and sustained inhibition of the BTK protein. BRUKINSA generated $3.9 billion in sales in 2025 ³, is approved in over 75 markets ⁴ and has launched in many key markets, including Europe, Japan, Korea and Brazil. BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. A tablet formulation was FDA approved in June 2025. BRUKINSA has approvals in five indications, including CLL/SLL, WM, R/R MCL, R/R MZL and R/R FL, and is approved in 77 markets ⁵ and reimbursed in 58 markets ⁶. The global BRUKINSA clinical development program includes over 7,900 patients ⁷ enrolled in more than 30 countries and regions across more than 45 trials ⁸, and more than 265,000 patients ⁹ have been treated globally.

TEVIMBRA is a humanized IgG4 monoclonal antibody against the immune checkpoint receptor programmed cell death protein 1 that we specifically designed to minimize binding to Fc receptor gamma. TEVIMBRA is currently approved in the U.S., EU, China and other countries, and is approved in 51 markets ¹⁰. The company has received regulatory approvals for TEVIMBRA marketing applications in multiple geographies, including the EU/European Medicines Agency (comprising 27 countries plus Iceland and Norway) and 23 countries across North America, Europe, Asia Pacific and other markets. Sonrotoclax is a potentially best-in-class BCL2 inhibitor designed to have greater potency and selectivity, and potential for better tolerability than venetoclax. In late 2025, we received the first approval for sonrotoclax for adult patients with R/R MCL and CLL/SLL patients who have received prior systemic therapy, including a BTK inhibitor. The approval, granted in China, is supported by data demonstrating deep and durable responses and manageable tolerability. Sonrotoclax is under Priority Review by the U.S. Food and Drug Administration for potential accelerated approval in the first half of 2026. The BTK-CDAC, BGB-16673, which is designed to promote the degradation of both wildtype and mutant forms of BTK, has best-in-class potential and is the most advanced BTK degrader in development, with more than 1,000 patients ¹¹ treated to date across the global CaDAnCe clinical development program.

In the second quarter of 2025, we redomiciled from the Cayman Islands to Switzerland. In July 2024, we opened our flagship U.S. campus for clinical R&D and biologics manufacturing in New Jersey, located on a 42-acre ¹² site at the Princeton West Innovation Park in Hopewell, New Jersey, with more than one million square feet ¹³ of developable real estate. This site has 8,000 liters ¹⁴ of large molecule biologics manufacturing capacity. Our manufacturing facility in Suzhou is 52,000 square meters ¹⁵ and consists of a manufacturing base for small molecule drug products with an annual production capacity of approximately 600 million tablets and capsules ¹⁶. Our commercial-scale large-molecule biologics manufacturing facility in Guangzhou is approximately 158,000 square meters ¹⁷. In 2024, we qualified Phase 3 capacity consisting of eight 5,000-liter bioreactors ¹⁸, increasing total capacity to 64,000 liters ¹⁹. In November 2025, we entered into an amendment to the Amgen Collaboration Agreement to extend our commercialization rights to XGEVA, BLINCYTO and KYPROLIS in the Collaboration Territory for so long as each product is sold. A significant portion of our rights to receive certain tiered mid-single digit royalty payments based on annual net revenue from sales outside of China of IMDELLTRA were sold to Royalty Pharma in the third quarter of 2025. As of February 13, 2026, we owned 68 issued U.S. patents ²⁰, 16 issued European patents ²¹, 34 issued Japanese patents ²², 72 issued China patents ²³.

In 2025, we generated total global revenue of approximately $5.3 billion ²⁴, increasing revenue by approximately 40.2% ²⁵ from the prior year, while achieving net income of $286.9 million ²⁶, net cash provided by operating activities of $1.1 billion ²⁷ and positive free cash flow of $941.7 million ²⁸. Product revenue has grown 39.8% ²⁹ since 2024. We achieved GAAP net income and non-GAAP net income for the first time in fiscal year 2025. As of December 31, 2025, we had cash and cash equivalents of $4.5 billion ³⁰ and debt of $1.0 billion ³¹. As of December 31, 2025, we had an accumulated deficit of $8.3 billion ³².

A key growth vector is the expansion of the foundational hematology franchise, led by BRUKINSA, which is supported by a broad clinical program with over 7,900 patients ³³ enrolled in more than 30 countries and regions across more than 45 trials ³⁴. The company plans to expand its leadership in CLL with its wholly-owned, emerging best-in-class hematology pipeline consisting of sonrotoclax and the BTK-CDAC (BGB-16673). The Phase 3 CELESTIAL-TNCLL trial of BRUKINSA plus sonrotoclax in 1L CLL has completed enrollment, and a Phase 3 study comparing BRUKINSA plus sonrotoclax against acalabrutinib plus venetoclax in 1L CLL has been initiated in the first half of 2026. An accelerated approval filing submission based on the Phase 2 trial of BGB-16673 in R/R CLL could be made to the FDA in 2026 if data supports such submission. The company believes it is uniquely positioned to lead a sustainable franchise in the approximately $12 billion ³⁵ global CLL market.

Another major growth vector is expanding access to the PD-1 inhibitor TEVIMBRA for patients worldwide and building global commercial capabilities to support the prolific pipeline. The company intends to expand TEVIMBRA's global footprint through ongoing submissions and approvals, including submissions based on the HERIZON-GEA-01 trial. A hyaluronidase-free, high-concentration subcutaneous formulation of TEVIMBRA is also being developed. In solid tumors, the company advanced five differentiated new molecular entities into the clinic in 2025, each with potential to be first-in-class or best-in-class. Five solid tumor programs achieved proof of concept in 2025, including the next-generation CDK4 inhibitor (BGB-43395), the potentially first-in-class B7-H4 ADC (BG-C9074), the first-in-class GPC3-dependent 4-1BB targeting bispecific T-cell engager (BGB-B2033), the potentially best-in-class PRMT5 (BGB-58067), and the CEA ADC (BG-C477). The company has over 70 preclinical programs ³⁶ and anticipates advancing many into the clinic in the next 12 months.

The filing discusses the company's cost structure and efficiency. The company's global development 'superhighway' is described as unique and critical to generating superior returns on R&D investment, allowing the company to execute more cost-efficient development and achieve faster time to clinical proof-of-concept. The company has built a highly productive and cost-effective oncology research team with 1,200+ scientists ³⁷, allowing it to drive serial innovation. The company's efforts have been validated by collaborations that have secured $1.5 billion ³⁸ in collaboration payments. The company achieved GAAP net income and non-GAAP net income for the first time in fiscal year 2025, indicating a trajectory towards profitability as product sales growth exceeded expense growth.

The company manufactures its medicines and drug candidates internally and with the help of contract manufacturing organizations. The Hopewell facility in New Jersey is now fully online with the successful technology transfer and qualification of the TEVIMBRA process, marking the first U.S.-based expected commercial manufacturing. The manufacturing facility in Suzhou has been in operation for clinical product supply since the beginning of 2024, with commercial supply in operation since May 2025. The Guangzhou facility's total biologics manufacturing capacity is approximately 65,000 liters ³⁹ following expansion. An ex-China active pharmaceutical ingredients source was approved by both FDA and EMA in 2025. The company continues to diversify its global supply network and does not anticipate any disruptions to supply.

The company's capital allocation strategy includes continued investment in R&D and capital expenditures. The company has invested in diverse technology platforms, including small molecules, CDAC protein degraders, bispecific antibodies, tri-specific antibodies, and ADCs. The company has more than 20 CDAC and degrader-antibody conjugate programs ⁴⁰ progressing through discovery, IND, and clinical development stages. Under the Amgen Collaboration Agreement, the company is contributing up to $1.25 billion ⁴¹ worth of development services and cash over the term of the collaboration. The company's board of directors has adopted a dividend policy which provides that we currently intend to retain all available funds and earnings, if any, to fund the development and expansion of our business, and we do not anticipate paying any cash dividends in the foreseeable future. We have never declared or paid any dividends on our ordinary shares or any other securities.

The filing identifies several headwinds and constraints. The company faces substantial competition from major pharmaceutical and biotechnology companies. The company's medicines may fail to achieve and maintain market acceptance. Clinical development involves a lengthy and expensive process with an uncertain outcome. The company is subject to extensive and complex government regulations in the U.S., China, Europe, and other jurisdictions. The company's business is subject to complex and evolving industry-specific laws and regulations regarding the collection and transfer of personal data. Changes in the political and economic policies of the PRC government or in relations between China and the U.S. or other governments may materially and adversely affect the business. The company has historically incurred significant net losses and may incur net losses in the future.

The filing identifies structural headwinds including pricing reform such as the Inflation Reduction Act in the U.S., which is placing direct and indirect pressure on innovators. The company also faces risks related to doing business in China, including that the PRC government may intervene or influence operations at any time, and there are uncertainties regarding the interpretation and enforcement of Chinese laws. The company's operations in China are subject to PRC laws and regulations, and the company's ability to pay dividends may be restricted by PRC regulations. The company's international business relationships subject it to additional risks, including unexpected changes in trade policy, including tariffs that have been or may in the future be imposed by the U.S. or other countries.

The company faces substantial competition from major pharmaceutical and biotechnology companies, and its medicines may fail to achieve market acceptance. Clinical development is lengthy and expensive with uncertain outcomes, and results of earlier studies may not be predictive of future trial results. The company is subject to extensive government regulation in the U.S., China, Europe, and other jurisdictions, and failure to comply could result in significant penalties, including withdrawal of approvals. Changes in the political and economic policies of the PRC government or in relations between China and the U.S. could materially and adversely affect the business, and the PRC government may intervene or influence operations at any time. The company has historically incurred significant net losses, with an accumulated deficit of $8.3 billion ⁴² as of December 31, 2025, and may incur net losses in the future. The company's ability to pay dividends is restricted by PRC regulations, and as of December 31, 2025, restricted net assets in China totaled $2.0 billion ⁴³.

Management's message emphasizes that the company is a leading global oncology company discovering and developing innovative treatments that are more accessible to cancer patients worldwide. The tone is one of significant achievement and strategic confidence, highlighting that in 2025, the company generated total global revenue of approximately $5.3 billion ⁴⁴, increasing revenue by approximately 40.2% ⁴⁵ from the prior year, while achieving net income of $286.9 million ⁴⁶, net cash provided by operating activities of $1.1 billion ⁴⁷ and positive free cash flow of $941.7 million ⁴⁸. Management states that the company achieved GAAP net income and non-GAAP net income for the first time in fiscal year 2025. The key strategic priorities emphasized for the period ahead include: expanding the foundational hematology franchise with BRUKINSA, sonrotoclax, and the BTK-CDAC to lead in the approximately $12 billion ⁴⁹ global CLL market; expanding access to TEVIMBRA for patients worldwide and building global commercial capabilities to support the prolific pipeline; and continuing to innovate with intentionality, building best-in-class combinations, and deploying capital thoughtfully and strategically, including actively exploring partnerships that strengthen the business.