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ONC · BeOne Medicines Ltd.

13 filings

10-K

ONC 10-K Annual Reports

BeOne Medicines Ltd. - 13 annual reports

Filing record · 2016–202610-K1310-Q328-K284

2025
BeOne Medicines Ltd. Annual Report, Year Ended Dec 31, 2025
BeOne Medicines Ltd. has demonstrated robust financial performance and significant pipeline progress in its 2025 annual report. The company achieved total global revenue of $5.3 billion, representing a 40.2% increase year-over-year, with a net income of $286.9 million. This growth was primarily driven by strong sales of BRUKINSA®, its leading Bruton's tyrosine kinase (BTK) inhibitor, which became the global market leader in B-cell malignancies and generated $3.9 billion in sales. The company also saw growth from TEVIMBRA®, its anti-PD-1 antibody, and its in-licensed products from Amgen. BeOne Medicines is strategically focused on expanding its differentiated hematology franchise with BRUKINSA, sonrotoclax (a next-generation BCL2 inhibitor with its first global approval in China), and its BTK chimeric degradation activation compound (BTK-CDAC). Sonrotoclax is currently under Priority Review by the FDA, with potential approval in the first half of 2026. The company's extensive clinical development programs, supported by its integrated global development "superhighway" and internal manufacturing capabilities, are designed to bring innovative and accessible treatments to patients worldwide.
Feb 26, 2026
2024-A
BeOne Medicines Ltd. Annual Report (Amendment), Year Ended Dec 31, 2024
BeOne Medicines Ltd. (ONC) has filed its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, with an amendment filed on February 28, 2025, to correct an inadvertent omission of a signature. This filing indicates ONC is a large accelerated filer and has undergone attestation of its internal control over financial reporting under Section 404(b) of SOX. The company is not a shell company, and as of June 28, 2024, its non-affiliate market capitalization was approximately $8.7 billion. The report also details the outstanding share structure, with over 1.38 billion ordinary shares outstanding, including ADSs and RMB shares. The primary purpose of this amendment is administrative, ensuring the proper execution of the original filing. Investors should note that no new financial data or operational updates are introduced by this specific amendment. The core financial and operational information from the original February 27, 2025, filing remains relevant for understanding the company's performance and position, with the incorporation by reference of portions of its definitive proxy statement for Part III disclosures.
Feb 28, 2025
2024
BeOne Medicines Ltd. Annual Report, Year Ended Dec 31, 2024
BeiGene Ltd. (ONC) demonstrated strong revenue growth in 2024, reaching $3.8 billion, a significant increase from the prior year, driven primarily by the robust performance of its flagship oncology drug, BRUKINSA®. The company also made strides in reducing its operating loss, achieving non-GAAP operating income for the first time and generating positive cash flows from operations in the latter half of 2024. This financial improvement is underpinned by BRUKINSA's market leadership in Chronic Lymphocytic Leukemia (CLL) in the U.S. and its expanding global reach. The company's strategic focus on a differentiated, wholly-owned hematology franchise with BRUKINSA, sonrotoclax, and its BTK-CDAC asset positions it well for sustained leadership in the $12 billion global CLL market. Beyond hematology, BeiGene is actively developing a deep pipeline in solid tumors, advancing 13 new molecular entities (NMEs) into the clinic in 2024, targeting prevalent cancers like breast, lung, and gastrointestinal cancers. The company's integrated business model, emphasizing internal clinical development capabilities and manufacturing, continues to be a key competitive advantage, enabling faster and more cost-effective development. BeiGene is well-positioned for continued growth and value creation for shareholders.
Feb 27, 2025
2023-A
BeOne Medicines Ltd. Annual Report (Amendment), Year Ended Dec 31, 2023
This filing is Amendment No. 1 (Form 10-K/A) to BeiGene, Ltd.'s (now BeOne Medicines, NASDAQ: ONC) annual report for fiscal year 2023, filed January 8, 2025. It does not contain the full consolidated financial statements, revenue, or segment data. It was filed to add parent-company-only condensed financial information (Schedule I, Rule 5-04 of Regulation S-X), which the company required because restricted net assets of its consolidated subsidiaries exceeded 25% of consolidated net assets at year-end 2023 and 2022. Investors should read it alongside the original 10-K filed February 26, 2024. The parent-only figures show a company whose holding-company liquidity has tightened. Parent net loss narrowed to $881.7 million in 2023 from $2,003.8 million in 2022, but parent cash and equivalents fell to $724.0 million from $1,742.3 million. Parent operating cash outflow was $1,168.6 million, up from $882.1 million, and was funded partly by $547.2 million of short-term bank debt, up from $297.9 million. Parent shareholders' equity declined to $3,537.3 million from $4,383.4 million. Investments in wholly owned subsidiaries rose to $1,207.4 million from $229.6 million, reflecting $883.3 million of capital injected into subsidiaries during 2023. The filing also discloses a $8.85 million remaining capital commitment on an equity investment and an unconditional parent guarantee of obligations of BeiGene Switzerland GmbH under the global strategic oncology collaboration with Amgen, with no amounts recognized. The auditors are Ernst & Young LLP and Ernst & Young Hua Ming LLP, both with reports dated January 8, 2025. The cover page also checks the box for error corrections in the financial statements, though this amendment does not explain the nature of those corrections. Non-affiliate market value was about $10.5 billion as of June 30, 2023.
Jan 8, 2025
2023
BeOne Medicines Ltd. Annual Report, Year Ended Dec 31, 2023
BeOne Medicines (formerly BeiGene, ticker ONC on the filing's naming; the filing itself is BeiGene, Ltd., Nasdaq: BGNE) reported total 2023 revenue of $2.46 billion, up 73.7% from $1.42 billion in 2022, while net loss narrowed 56% to $881.7 million from $2.0 billion. Growth was driven by BRUKINSA, whose global sales rose 128.5% to $1.29 billion, with U.S. sales up 142.6% to $945.6 million, and by tislelizumab (TEVIMBRA) in China, up 26.9% to $536.6 million. Collaboration revenue of $268.9 million was boosted by the one-time recognition of deferred revenue after the Novartis tislelizumab and ociperlimab agreements were terminated in 2023. Profitability remains distant. Loss from operations was $1.21 billion, improved from $1.79 billion, as product gross margin expanded to roughly 83% and operating expenses grew 12.6% to $3.29 billion. Adjusted operating loss narrowed to $752 million. Net loss was also flattered by a non-cash $362.9 million gain from the BMS settlement, which returned 23.3 million shares. The company held $3.2 billion of cash and equivalents at year-end, against $886 million of debt, most of it short-term, and reported an accumulated deficit of $8.0 billion. Management states current cash should fund operations for at least 12 months. Key investor watch items include continued BRUKINSA launch momentum in the U.S. and Europe, the pace of Chinese NRDL price reductions on tislelizumab and other products, the cash burn from ongoing R&D (including sonrotoclax Phase 3 programs) and capital spending on the Hopewell, New Jersey facility, and risks tied to PRC regulation, HFCAA compliance, and the Pharmacyclics patent suit against BRUKINSA.
Feb 26, 2024
2022
BeOne Medicines Ltd. Annual Report, Year Ended Dec 31, 2022
BeOne Medicines Ltd. (formerly BeiGene, ticker ONC on NASDAQ, shown as BGNE in this filing) reported a fiscal 2022 net loss of $2.0 billion on total revenue of $1.42 billion, up 20.4% year over year, in this 10-K filed February 27, 2023. Growth came mainly from product sales, which rose 97.9% to $1.25 billion, led by BRUKINSA (up 159% to $565 million) and tislelizumab (up 66% to $423 million, almost entirely in China). Collaboration revenue fell 70% to $161 million because 2021 included roughly $485 million of license revenue recognized from the Novartis tislelizumab deal. Operating expenses rose 23% to $3.2 billion, with R&D at $1.64 billion and SG&A at $1.28 billion, so the company remains far from profitability and its accumulated deficit reached $7.1 billion. Liquidity is still substantial but declining. Cash, equivalents and restricted cash were $3.9 billion and short-term investments were $0.67 billion at year-end, against total debt of $538 million, and management says existing resources cover at least the next 12 months. Operating cash burn was $1.5 billion in 2022. The company has commitments including $595.7 million of remaining Amgen co-development funding, $405 million of capital commitments mainly for the New Jersey and Suzhou campuses, and $329 million of debt due within a year. The main investor issues are concentration and regulatory exposure. BRUKINSA and tislelizumab carry most of the revenue, China pricing and NRDL reimbursement cuts shape margins, and the company faces PRC regulatory, data and listing risks, including the HFCAA auditor issue, which the filing says was addressed by moving to Ernst & Young LLP (US). Amgen's AMG 510 (sotorasib) was dropped from the cost-share program, and an arbitration with BMS over ABRAXANE is pending.
Feb 27, 2023
2021
BeOne Medicines Ltd. Annual Report, Year Ended Dec 31, 2021
This Form 10-K covers fiscal year 2021 for BeiGene, Ltd. (NASDAQ: BGNE; HKEx: 06160; STAR Market: 688235). The filing was made February 28, 2022. The user's request refers to "BeOne Medicines Ltd. (ONC)," but the document itself is BeiGene's annual report. BeiGene is the predecessor name of the company now known as BeOne Medicines. Total revenue rose 280.8% to $1.18 billion, driven by $542.3 million of collaboration revenue, mainly the $484.6 million license recognized under the January 2021 Novartis tislelizumab agreement. Product revenue grew 105% to $634.0 million, led by tislelizumab ($255.1 million in China), BRUKINSA ($218.0 million globally, including $115.7 million in the U.S.), and in-licensed Amgen products. Despite the revenue step-up, the company posted a net loss of $1.41 billion, versus $1.60 billion in 2020, and an accumulated deficit of $5.0 billion. R&D expense was $1.46 billion and SG&A was $990 million as the company scaled its global commercial and clinical organizations. The balance sheet was strengthened substantially during the year. The December 2021 STAR Market offering raised about $3.4 billion net, and total cash, cash equivalents, and restricted cash reached $4.38 billion, with another $2.24 billion in short-term U.S. Treasury investments. Against $629.7 million of debt, the company said existing resources should fund operations for at least 12 months. Operating cash burn was still about $1.3 billion in 2021. Gross margin on product sales declined to 74.0% from 77.1%, mainly because of National Reimbursement Drug List (NRDL) price reductions and roughly $57.5 million of distributor compensation for pre-NRDL inventory. Key investor considerations include the company's dependence on China pricing policy (NRDL inclusion and volume-based procurement), its continued losses, the arbitration with BMS over ABRAXANE supply and license termination, and the Holding Foreign Companies Accountable Act (HFCA) risk arising from the PCAOB's inability to inspect its China-based auditor. These factors are balanced by the Novartis upfront payments ($650 million received in 2021, $300 million received in January 2022 for ociperlimab) and the expanding BRUKINSA and tislelizumab footprint.
Feb 28, 2022
2020
BeOne Medicines Ltd. Annual Report, Year Ended Dec 31, 2020
BeiGene, Ltd. (NASDAQ: BGNE; HKEx: 06160) reported its FY2020 Form 10-K on February 25, 2021, describing a global, commercial-stage biotechnology company that is still in a heavy investment phase. Total FY2020 revenue was $308.9 million, up 38.8% from product sales alone, but collaboration revenue fell to zero after the $150 million BMS termination payment in 2019, so total revenue declined 27.9% year over year. Net loss widened to $1.60 billion (EPS of -$1.47), driven by R&D of $1.29 billion (up 39.6%) and SG&A of $600 million (up 54.6%). The accumulated deficit reached $3.6 billion, and operating cash burn was $1.28 billion. The balance sheet was substantially strengthened in 2020. Cash, equivalents and restricted cash plus short-term investments totaled roughly $4.66 billion at year-end, and the Amgen share purchase ($2.78 billion for a 20.5% stake) and a July 2020 registered direct offering (about $2.07 billion net) funded the buildup. Total debt rose to $518.7 million, largely from short-term Chinese bank loans. Management states that existing resources are sufficient for at least 12 months, but notes that they may not fully fund all planned global development and launches. The investment case rests on BRUKINSA (zanubrutinib) and tislelizumab, which are now marketed in China and, for BRUKINSA, the U.S. Key near-term catalysts include the January 2021 Novartis tislelizumab deal ($650 million upfront, expected to close in Q1 2021), NRDL reimbursement listing effective March 2021 (which the company expects to pressure near-term China pricing), and a planned STAR Market listing. Key risks include the ABRAXANE supply suspension in China, which has halted sales of that product, competition and generic pressure on BMS-licensed products, Amgen collaboration execution, dependence on China operations, and PCAOB/HFCA Act auditor-inspection exposure that could threaten ADS listing.
Feb 25, 2021
2019
BeOne Medicines Ltd. Annual Report, Year Ended Dec 31, 2019
BeiGene, Ltd. (Nasdaq: BGNE; HKEx: 06160) reported its Form 10-K for fiscal 2019, filed March 2, 2020, as a commercial-stage oncology company in transition. Revenue rose 116% to $428.2 million, driven by $222.6 million in product revenue (mainly BMS-licensed ABRAXANE, REVLIMID and VIDAZA in China, plus first U.S. BRUKINSA sales after the November 2019 FDA accelerated approval) and $205.6 million of collaboration revenue, which includes a one-time $150 million payment from BMS on termination of the tislelizumab collaboration. Despite the revenue growth, the company remains deeply loss-making: net loss widened to $950.6 million, R&D rose to $927.3 million, SG&A to $388.2 million, and the accumulated deficit reached $2.0 billion. Operating cash burn was $750.3 million. The balance-sheet picture changes materially after year-end. On January 2, 2020, Amgen closed a collaboration under which it bought a 20.5% stake for about $2.78 billion at $174.85 per ADS, and BeiGene agreed to co-fund up to $1.25 billion of development for 20 Amgen pipeline assets while commercializing XGEVA, KYPROLIS and BLINCYTO in China. Cash, cash equivalents and short-term investments were $985.5 million at December 31, 2019, so this infusion is significant. Management states that existing resources fund operations for at least 12 months, and the company also licensed SYLVANT and QARZIBA from EUSA for a $40 million upfront payment. Investors should weigh a clear commercial ramp and a substantial pipeline (tislelizumab, zanubrutinib, pamiparib, lifirafenib) against high cash burn, dependence on China pricing and reimbursement (including the centralized procurement that will cut ABRAXANE prices), and material disclosure of COVID-19 disruption to China operations. The filing also flags regulatory, PRC legal and tax uncertainties and the ASPEN Phase 3 trial, which missed its primary endpoint of superiority over ibrutinib in Waldenström's macroglobulinemia.
Mar 2, 2020
2018
BeOne Medicines Ltd. Annual Report, Year Ended Dec 31, 2018
BeiGene, Ltd. (the filing's company; the prompt labels it BeiOne/ONC, but the 10-K identifies it as BeiGene, Ltd., Nasdaq: BGNE and HKEx: 06160) reported its FY2018 Form 10-K on February 28, 2019. The company is a commercial-stage oncology biotech with three late-stage internal candidates: zanubrutinib (BTK inhibitor), tislelizumab (anti-PD-1), and pamiparib (PARP1/2 inhibitor). It has three new drug applications under priority review or accepted in China, with U.S. zanubrutinib filings planned for 2019 or early 2020. Current revenue comes from marketing three in-licensed Celgene drugs in China (ABRAXANE, REVLIMID, VIDAZA), which generated $130.9M of net product revenue in 2018, up from $24.4M in 2017. Financially, the company is far from profitability. Total revenue was $198.2M, down 17% from $238.4M, because 2017 included a one-time $211.4M Celgene license fee. R&D rose 152% to $679.0M and SG&A rose 212% to $195.4M, producing a net loss of $674.0M (EPS of -$0.93) versus $93.3M in 2017. Operating cash burn was $547.7M, and the accumulated deficit reached $1.0B. Liquidity was strong after $1.6B of net equity raised in 2018 (a January ADS offering and an August dual listing and offering in Hong Kong). Cash, equivalents, restricted cash, and short-term investments totaled about $1.8B at year-end. Management says this covers operations for at least 12 months but not all planned global launches. Key investor considerations include the pending Bristol-Myers Squibb acquisition of Celgene (expected Q3 2019), which could terminate the tislelizumab license and return full rights to BeiGene along with a termination fee; China pricing and reimbursement pressure, including generic competition to ABRAXANE, REVLIMID, and VIDAZA; and the high concentration of clinical and regulatory risk in a few pipeline assets. Other risks include PRC regulatory uncertainty and the Cayman Islands structure, along with the possibility of PFIC and PRC tax residency issues.
Feb 28, 2019
2017
BeOne Medicines Ltd. Annual Report, Year Ended Dec 31, 2017
BeiGene, Ltd. (ONC) reported its FY2017 Form 10-K on February 28, 2018 as a commercial-stage, Beijing-based, immuno-oncology and targeted-oncology company. Its results were dominated by a one-time $263 million upfront payment from Celgene for tislelizumab (anti-PD-1) rights outside Asia, which drove total 2017 revenue to $238.4 million from $1.1 million in 2016. Excluding that licensing revenue, the company remains deeply loss-making: net loss attributable to BeiGene was $93.1 million (vs. $119.2 million in 2016), R&D expense rose 174% to $269.0 million, and SG&A rose 211% to $62.6 million as the company built out its China commercial team and clinical programs. Net product revenue of $24.4 million came from distributing Celgene's ABRAXANE and REVLIMID in China since September 2017. The balance sheet strengthened materially. Cash, equivalents and short-term investments were $837.5 million at year-end 2017, and the company raised approximately $758.0 million in net proceeds from a January 2018 ADS offering at $101.00 per ADS, which is not included in the year-end figures. Management states existing resources are sufficient for at least 12 months but not for all planned global development and launches, implying further capital needs. Accumulated deficit reached $330.5 million, and the company carries a $164.7 million debt-type obligation mix including a shareholder loan from GET and a long-term bank loan. Key investor considerations are the pipeline catalysts (zanubrutinib and tislelizumab China filings planned for 2018, several global Phase 3 trials), the concentration of ownership (directors, officers and principal shareholders hold about 61.2%), the Cayman Islands and PRC structure with associated tax and regulatory risks, the auditor PCAOB inspection limitation, and the company's note that it is not currently a PFIC for 2017 but may become one in future years. Revenue quality is also a concern, since 2017 collaboration revenue was largely a non-recurring upfront license recognition.
Feb 28, 2018
2016
BeOne Medicines Ltd. Annual Report, Year Ended Dec 31, 2016
BeOne Medicines Ltd. (ONC), a clinical-stage biopharmaceutical company, is focused on discovering and developing innovative molecularly targeted and immuno-oncology drugs for cancer treatment. As of March 2017, the company has four clinical-stage drug candidates: BGB-3111 (BTK inhibitor), BGB-A317 (PD-1 inhibitor), BGB-290 (PARP inhibitor), and BGB-283 (RAF dimer inhibitor). These candidates are in various stages of clinical trials globally, with a significant focus on China where the company believes it can leverage a distinct regulatory pathway for faster approvals. BeOne Medicines has developed a proprietary cancer biology platform that aims to improve drug discovery by incorporating advanced models that better mimic tumor-immune system interactions. The company's strategy involves advancing its pipeline through global development, pursuing combination therapies, and leveraging its platform to discover new candidates. BeOne Medicines retains global rights for its pipeline assets, with limited past collaborations that have since been repurchased or terminated. The company has successfully raised substantial capital through public offerings to fund its extensive research and development activities, though it continues to incur net losses. Investors should note the significant risks associated with clinical development, regulatory approvals, competition, and the need for future financing.
Mar 22, 2017
2015
BeOne Medicines Ltd. Annual Report, Year Ended Dec 31, 2015
BeOne Medicines Ltd. (ONC), a biopharmaceutical company focused on oncology, is in the clinical stage of developing innovative molecularly targeted and immuno-oncology drugs. As of its March 30, 2016, 10-K filing, the company had not yet generated product revenue but was advancing four key clinical-stage drug candidates: BGB-3111 (BTK inhibitor), BGB-A317 (PD-1 inhibitor), BGB-290 (PARP inhibitor), and BGB-283 (RAF dimer inhibitor). The company's strategy centers on its proprietary cancer biology platform, which aims to improve drug discovery by incorporating novel tumor-immune system interaction models. BeOne Medicines highlights its strong R&D team, its strategic positioning in China with potential regulatory advantages, and its focus on developing combination therapies. The company had recently completed an initial public offering (IPO) in February 2016, raising approximately $166.6 million in net proceeds, which it plans to use for ongoing clinical development, R&D, manufacturing facility expansion, and general corporate purposes.
Mar 30, 2016