BGNE
Beigene, LTD
NASDAQ
10-K: BeiGene Reports Strong 2024 Revenue Growth, Driven by BRUKINSA; Achieves Positive Non-GAAP Operating Income
Sentiment:
Annual Results
27 February 2025 6:12 AM
BeiGene's 2024 results showcase significant revenue growth and progress in hematology and solid tumor pipelines, marking a transition towards sustainable profitability.
Delay expected
The FDA deferred approval for tislelizumab in first-line unresectable, recurrent, locally advanced, or metastatic ESCC on account of a delay in scheduling clinical site inspections.
Summary
- BeiGene's 2024 total global revenue reached approximately $3.8 billion, a $1.4 billion increase from the previous year.
- The company reduced its operating loss by approximately $0.6 billion compared to the prior year.
- BRUKINSA generated $2.6 billion in sales in 2024 and is approved in over 70 markets.
- The company advanced 13 differentiated new molecular entities (NMEs) into the clinic in 2024.
- BeiGene plans to redomicile its holding company to Switzerland in 2025.
- The company achieved non-GAAP operating income for the first time in fiscal year 2024.
- BeiGene generated positive cash flows from operations for the first time in both the third and fourth quarters of 2024.
- As of December 31, 2024, BeiGene had cash and cash equivalents of $2.6 billion.
Sentiment
Score: 7
Explanation: The document presents a balanced view with strong revenue growth and pipeline progress offset by ongoing losses and competitive pressures. The outlook is cautiously optimistic.
Positives
- Significant revenue growth driven by BRUKINSA and other products.
- Reduction in operating losses and achievement of non-GAAP operating income.
- Positive cash flow from operations in the third and fourth quarters of 2024.
- Advancement of multiple new drug candidates into clinical trials.
- Broadest label for BRUKINSA among BTK inhibitors.
- Plans to initiate a Phase 3 trial for BTK-CDAC.
- Strong cash position of $2.6 billion.
Negatives
- The company has historically incurred significant net losses and may incur net losses in the future.
- Reliance on third parties for manufacturing and clinical trials poses risks.
- The company faces substantial competition in the oncology market.
- The company is subject to complex and evolving industry-specific laws and regulations.
- The company is subject to the risks and challenges of doing business globally, including in China.
Risks
- Failure of medicines to achieve market acceptance.
- Substantial competition from other pharmaceutical companies.
- Uncertainty in clinical trial outcomes and regulatory approvals.
- Reliance on third parties for manufacturing and clinical trials.
- Complex and evolving regulatory landscape.
- Potential impact of healthcare reforms and pricing pressures.
- Risks associated with operating in China, including political and economic changes.
- Potential for product liability claims and lawsuits.
- Cybersecurity threats and data breaches.
Future Outlook
BeiGene anticipates achieving positive GAAP operating income and operating cash flow for full year 2025 and expects significant growth from its current portfolio and cornerstone assets.
Management Comments
- BRUKINSA is now the unequivocal leader in new CLL patient starts in the U.S.
- 2025 marks an inflection point as we anticipate achieving positive GAAP operating income and operating cash flow alongside our intention to change our name to BeOne with our new NASDAQ ticker, ONC.
Industry Context
The report highlights BeiGene's position in the competitive oncology landscape, noting key competitors and the potential for its pipeline products to address unmet medical needs.
Comparison to Industry Standards
- Global revenues for BTK inhibitors were over $10 billion in 2024 and are projected to be more than $15 billion in 2028.
- The top four PD-1/PD-L1 antibody medicines had revenues of approximately $45 billion in 2024.
- The 2024 China PD-1/L1 market was approximately $3.4 billion.
- Competitors for BRUKINSA include AbbVie & Janssen's IMBRUVICA and AstraZeneca's CALQUENCE.
- Competitors for TEVIMBRA include Merck's KEYTRUDA and Bristol Myers Squibb's OPDIVO.
- Competitors for sonrotoclax include AbbVie & Roche's VENCLEXTA and Ascentage Pharma's Lisaftoclax.
- Competitors for BGB-16673 include Eli Lilly (Loxo Oncology)'s JAYPIRCA and Nurix Therapeutics' NX-5948.
Stakeholder Impact
- Shareholders can expect continued investment in growth and potential for long-term value creation.
- Patients may benefit from the development and commercialization of innovative cancer therapies.
- Employees can expect opportunities for growth and development within the company.
Next Steps
- Continue pivotal-stage programs for sonrotoclax and BGB-16673.
- Advance solid tumor pipeline programs.
- Pursue regulatory approvals for BRUKINSA globally, including a new tablet formulation.
- Expand TEVIMBRA's global footprint through ongoing submissions and approvals.
- Continue to explore partnerships that strengthen the business.
Legal Proceedings
- Pharmacyclics filed a patent infringement suit against BeiGene alleging that BRUKINSA infringes a Pharmacyclics patent.
- BeiGene filed patent infringement suits against Sandoz and MSN Pharmaceuticals in response to ANDA filings for a generic version of BRUKINSA.
- AbbVie filed a lawsuit alleging misappropriation of trade secrets concerning BeiGene's Brutons tyrosine kinase degrader program.
Key Dates
- October 28, 2010: BeiGene, Ltd. incorporated in the Cayman Islands
- February 3, 2016: BeiGene ADSs begin trading on the Nasdaq Global Select Market
- August 8, 2018: BeiGene ordinary shares begin trading on the Stock Exchange of Hong Kong Limited
- October 31, 2019: BeiGene enters into a collaboration agreement with Amgen
- January 2, 2020: Effective date of the Amgen collaboration agreement
- December 15, 2021: BeiGene RMB Shares begin trading on the STAR Market of the Shanghai Stock Exchange
- March 30, 2022: SEC adds BeiGene to its conclusive list of issuers identified under the HFCAA
- March 23, 2022: Ernst & Young Hua Ming LLP resigns as BeiGene's independent registered public accounting firm
- March 23, 2022: Ernst & Young LLP (U.S.) engaged as BeiGene's independent registered public accounting firm
- December 2022: PCAOB secures complete access to inspect and investigate registered public accounting firms headquartered in mainland China and Hong Kong
- February 2023: BeiGene amends Amgen collaboration agreement to stop cost-sharing for AMG 510
- September 2023: BeiGene and Novartis mutually terminate the tislelizumab collaboration and license agreement
- August 1, 2023: BeiGene enters into a Settlement and Termination Agreement with BMS
- March 8, 2024: BeiGene files patent infringement suits against Sandoz and MSN Pharmaceuticals
- April 2024: BeiGene opens a new campus equipped with a state-of-the-art ADC production facility in Guangzhou
- May 2024: China NMPA is reviewing a BLA for zanidatamab for the BTC indication
- July 2024: BeiGene opens its flagship U.S. campus for clinical R&D and biologics manufacturing in New Jersey
- July 2024: Jazz announces that the Marketing Authorisation Application for zanidatamab in 2L BTC was validated by the European Medicines Agency
- November 20, 2024: FDA grants accelerated approval of ZIIHERA to Jazz for previously treated unresectable or metastatic HER2-positive biliary tract cancer
- November 27, 2024: European Commission approves TEVIMBRA in combination with chemotherapy for ESCC and G/GEJ adenocarcinoma
- December 12, 2024: BeiGene enters into a global licensing agreement with CSPC Zhongqi Pharmaceutical Technology for SYH2039
- December 23, 2024: BeiGene's American Depository Shares will begin trading on the Nasdaq Global Select Market under the new ticker symbol ONC as of January 2, 2025
- December 27, 2024: FDA approves TEVIMBRA in combination with platinum and fluoropyrimidine-based chemotherapy for first-line treatment of HER2-negative G/GEJ adenocarcinoma
- Early 2025: Planned confirmatory Phase 3 study for BGB-16673
- Q1 2025: CELESTIAL-TN CLL Phase 3 trial enrollment completed
- 2025: BeiGene plans to redomicile to Switzerland
- July 1, 2025: Interim Provisions for the Management of Domestic Responsible Persons Designated by Foreign Drug Marketing Authorization Holders will come into effect
Keywords
BGNE
Beigene, LTD
NASDAQ
Sector: TBD
Filings with Classifications
Capital raise
18 June 2025 5:10 PM
Insider Transaction Report
- The document references an 'RMB Shares Employee Participation Plan' through which certain executive officers and qualified employees, including the Reporting Person, indirectly purchased RMB Shares directly from the Issuer in its initial public offering on the STAR Market.
- The plan purchased an aggregate of 2,069,546 RMB Shares directly from the Issuer at the initial public offering price of RMB192.6 per RMB Share.
- The Reporting Person contributed RMB10 million to this plan, indicating a capital inflow to the company specifically for this employee program.
Capital raise
21 May 2025 4:45 PM
8-K Filing
- The company has been granted a share issue mandate to the Board of Directors to issue, allot or deal with unissued ordinary shares and/or American Depositary Shares (ADSs) (including any sale or transfer of treasury shares out of treasury) not exceeding 20% of the total number of issued shares of the Company (excluding treasury shares) as of the date of passing of such ordinary resolution up to the next annual general meeting of shareholders of the Company, subject to the conditions described in the Proxy Statement (the General Mandate to Issue Shares).
Worse than expected
13 May 2025 8:15 PM
Shareholder Ownership Change
- The filing indicates that HHLR Advisors and Hillhouse Investment Management have reduced their stake in BeiGene, Ltd. to 4.9% and have filed an 'exit filing', signifying their intention to no longer report their holdings on Schedule 13D.
- A fund managed by HHLR sold 16,000,000 Ordinary Shares in a block trade, which represents a substantial divestment by a key institutional investor.
- While the filing is a disclosure of a transaction, the reduction of a significant stake by a major investor can be interpreted by the market as a negative signal regarding the company's future prospects or the investor's portfolio strategy.
Better than expected
7 May 2025 6:09 AM
Quarterly Report (Form 10-Q)
- The company achieved GAAP profitability, a significant improvement from the prior-year period loss.
- Revenue growth was strong, driven by Brukinsa sales.
- Operating cash flow improved.
Better than expected
7 May 2025 6:04 AM
Earnings Release
- The company achieved GAAP profitability for the first time.
- Revenue growth significantly exceeded expectations.
- BRUKINSA sales demonstrated strong performance and market share gains.
Better than expected
29 April 2025 5:03 PM
Current Report
- BeiGene successfully invalidated the patent claims against BRUKINSA, removing a potential legal hurdle.
Capital raise
7 April 2025 10:07 AM
Proxy Statement
- The company is seeking approval for a share issue mandate to issue, allot or deal with unissued ordinary shares and/or American Depositary Shares (ADSs) not exceeding 20% of the total number of issued shares of the Company.
- The company is seeking approval to allocate to Amgen Inc. up to a maximum amount of shares in order to maintain the same shareholding percentage of Amgen.
Capital raise
7 April 2025 6:03 AM
Proxy Statement
- The company is seeking shareholder approval for a general mandate to issue shares, allowing the Board of Directors to issue up to 20% of the company's outstanding shares.
- The company is seeking shareholder approval for a connected person placing authorization, allowing the company to allocate shares to Amgen in securities offerings to maintain its shareholding percentage.
Better than expected
7 April 2025 6:03 AM
Proxy Statement
- The company's revenue growth is expected to outpace costs in 2025.
- The company anticipates positive GAAP operating income and cash flow generation from operations in 2025.
- BRUKINSA generated $2.6 billion in global revenue in 2024, a 105% increase from the prior year.
Worse than expected
4 March 2025 2:30 AM
Beneficial Ownership Amendment
- The sale of a significant block of 2,480,000 ADSs by HHLR Fund, a major investor, indicates a reduction in their stake, which is generally perceived as a negative signal by the market.
Worse than expected
28 February 2025 9:28 PM
SEC Form 4 Filing
- The document contains worse than expected results because a major shareholder is selling a significant number of shares, which could indicate a lack of confidence in the company's future prospects.
Delay expected
27 February 2025 6:12 AM
Annual Results
- The FDA deferred approval for tislelizumab in first-line unresectable, recurrent, locally advanced, or metastatic ESCC on account of a delay in scheduling clinical site inspections.
Better than expected
27 February 2025 6:04 AM
Earnings Release
- The company's revenue growth exceeded expectations, driven by strong BRUKINSA sales.
- BeiGene narrowed its GAAP operating loss and achieved positive non-GAAP operating income, indicating improved profitability.
- The company's 2025 revenue guidance suggests continued growth and profitability.
Better than expected
13 January 2025 5:02 PM
Financial Guidance
- The company's expectation of positive operating income is better than the typical financial performance of a development stage biotechnology company.
Worse than expected
10 December 2024 9:25 PM
SEC Form 4 Filing
- The document details a significant sale of shares by a major shareholder, which is generally considered a negative signal.
Better than expected
12 November 2024 6:06 AM
Quarterly Report
- The company's revenue growth exceeded expectations, driven by strong sales of BRUKINSA.
- The company's net loss improved compared to the same period last year, indicating progress towards profitability.
- The company's pipeline development is progressing faster than expected, with eight new molecular entities entering clinical trials year-to-date.
Delay expected
12 November 2024 6:06 AM
Quarterly Report
- The FDA deferred approval for tislelizumab in first-line unresectable, recurrent, locally advanced, or metastatic ESCC on account of a delay in scheduling clinical site inspections.
Better than expected
12 November 2024 6:03 AM
Quarterly Report
- The company's non-GAAP operating income of $66 million is significantly better than the $16 million loss in the same period last year.
- BRUKINSA sales growth of 87% in the US and 217% in Europe exceeded expectations.
- The company's pipeline expansion with four new molecular entities entering clinical trials is a positive development.
Capital raise
30 September 2024 6:02 AM
Risk Factor Update
- The document states that BeiGene may need to obtain additional financing to fund its operations.
- The company may seek funding through public or private offerings, debt financing, collaboration and licensing arrangements, or other sources.
- The document also mentions that raising additional capital may cause dilution to shareholders.
Delay expected
30 September 2024 6:02 AM
Risk Factor Update
- The document mentions delays in regulatory approvals for tislelizumab due to the inability to complete inspections.
- The document also notes that clinical trials may be delayed due to difficulties in patient enrollment.
Worse than expected
30 September 2024 6:02 AM
Risk Factor Update
- The document highlights significant financial risks, including continued net losses and the need for additional financing, indicating worse than expected financial performance.
- The document details numerous operational and regulatory challenges, suggesting a more difficult path to profitability than might have been anticipated.
Capital raise
7 August 2024 6:07 AM
Quarterly Report
- The company may need to obtain additional financing to fund its operations.
- The company has filed a shelf registration statement with the SEC for the issuance of an unspecified amount of securities.
Delay expected
7 August 2024 6:07 AM
Quarterly Report
- The FDA has deferred approval for tislelizumab in first-line unresectable, recurrent, locally advanced, or metastatic ESCC on account of a delay in scheduling clinical site inspections.
Better than expected
7 August 2024 6:07 AM
Quarterly Report
- The company's revenue growth exceeded expectations, driven by strong sales of BRUKINSA and other products.
- The company achieved positive adjusted operating income, a significant improvement over previous quarters.
- The company's gross margin on product sales increased to 85.0%, indicating improved profitability.
Delay expected
7 August 2024 6:04 AM
Quarterly Report
- The U.S. FDA deferred approval for tislelizumab in first-line ESCC due to a delay in scheduling clinical site inspections.
Better than expected
7 August 2024 6:04 AM
Quarterly Report
- The company achieved non-GAAP operating income, which was better than the expected loss.
- The company's revenue growth, particularly for BRUKINSA, was significantly higher than expected.
- The company's GAAP operating loss decreased by 66%, which was better than expected.
Capital raise
5 June 2024 4:35 PM
Annual General Meeting Results
- The company received approval for a general mandate to issue shares, not exceeding 20% of the total number of issued ordinary shares.
- The company also received authorization to allocate shares to Baker Bros. Advisors LP, Hillhouse Capital Management, Ltd., and Amgen Inc. to maintain their shareholding percentages, which could involve a capital raise.
Capital raise
8 May 2024 6:09 AM
Quarterly Report
- The company may need to obtain additional financing to fund its operations.
- The company has a shelf registration statement with the SEC for the issuance of an unspecified amount of securities.
- The company may seek additional funding through a combination of equity offerings, debt financings, collaboration agreements, strategic alliances, licensing arrangements, government grants, and other available sources.
Better than expected
8 May 2024 6:09 AM
Quarterly Report
- The company's revenue growth and improved gross margin exceeded expectations.
- The company's net loss was lower than the same period last year, indicating progress towards profitability.
Delay expected
8 May 2024 6:06 AM
Quarterly Report
- The pending FDA approval for tislelizumab in first-line unresectable ESCC may be deferred due to a potential delay in scheduling clinical site inspections.
Better than expected
8 May 2024 6:06 AM
Quarterly Report
- The company's revenue growth significantly exceeded expectations, driven by strong sales of BRUKINSA.
- The company's operating losses improved more than expected, indicating progress towards profitability.
- The company achieved key regulatory approvals and pipeline advancements, exceeding expectations.
Capital raise
26 April 2024 4:16 PM
Proxy Statement
- The document includes a proposal for a general mandate to issue shares and/or ADSs, not exceeding 20% of the total number of issued shares.
- The document includes proposals to authorize the allocation of shares to existing shareholders (Baker Bros. Advisors LP and Hillhouse Capital Management, Ltd.) and Amgen Inc. to maintain their shareholding percentages in future offerings.
Better than expected
23 April 2024 4:13 PM
Regulatory Approval Announcement
- The European Commission approval for tislelizumab is a positive development and better than expected as it expands the market for the drug and validates its efficacy in treating NSCLC.
Better than expected
15 March 2024 4:52 PM
Drug Approval Announcement
- The RATIONALE 302 trial showed a statistically significant and clinically meaningful survival benefit for TEVIMBRA compared to chemotherapy, with a median overall survival of 8.6 months versus 6.3 months.
Better than expected
26 February 2024 6:02 AM
Annual Results
- The company's revenue growth of 74% for the full year and 67% for the quarter exceeded expectations.
- The 129% growth in BRUKINSA sales was significantly better than anticipated.
- The reduction in operating losses was better than the prior year.
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