百濟神州有限公司連同其子公司（「本公司」或「百濟神州」或「我們」）謹此公佈本 公司截至2024年12月31日止年度（「報告期」）的綜合業績連同2023年相應期間的 比較數字，其乃根據美國公認會計原則（「美國公認會計原則」或「GAAP」）編製並 由本公司董事會（「董事會」）審計委員會（「審計委員會」）審閱。 財務摘要 1 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 • 截至2024年12月31日止年度的收入合計較截至2023年12月31日止年度增加 約14億美元或約55.0%至約38億美元。產品收入較截至2023年12月31日止 年度增加約16億美元或約72.6%至約38億美元。 • 截至2024年12月31日止年度的經營費用合計較截至2023年12月31日止年度 增加約497.8百萬美元或約15.1%至約3,784.4百萬美元。 • 截至2024年12月31日止年度的淨虧損較截至2023年12月31日止年度減少約 236.9百萬美元或約26.9%至 ...

Investment Rating - The report initiates coverage with an OUTPERFORM rating for BeiGene [2]. Core Insights - BeiGene is positioned as a leading biopharma company in China, focusing on innovative drug development and global commercialization, with a strong pipeline and significant growth potential [3][11]. - The company is expected to achieve profitability by 2025, driven by the strong performance of its core products, particularly the BTK inhibitor, Zanubrutinib, and the PD-1 inhibitor, Tislelizumab [4][20]. Summary by Sections 1. Innovative Product Globalization - BeiGene has established a robust global presence with over 60 clinical projects and 17 commercialized products, including Zanubrutinib and Tislelizumab, which have been launched in multiple regions [3][11]. - The company aims to become the first biopharma in China to achieve recurring profitability by 2025, supported by its innovative product pipeline and global commercialization capabilities [11][20]. 2. Leadership in Hematology - The combination of BTK inhibitors, BCL-2 inhibitors, and BTK CDAC is expected to solidify BeiGene's leadership in hematological malignancies [5][27]. - Zanubrutinib is projected to double its revenue to $2.6 billion in 2024, further strengthening its market position in the U.S. hematology market [4][20]. 3. Pipeline Development - BeiGene's pipeline focuses on hematological and solid tumors, with several molecules showing best-in-class potential, including Sonrotoclax and BGB-16673 [27]. - The company has a rich pipeline with over 10 early-stage projects expected to report proof-of-concept data in 2025, enhancing its growth prospects [6][27]. 4. Financial Projections and Valuation - Revenue projections for FY25-27 are $5 billion, $6 billion, and $6.7 billion, respectively, with a CAGR of 21% [7]. - The target price is set at HK$182.35, based on a discounted cash flow model with a WACC of 9% and a perpetual growth rate of 4% [7].

Investment Rating - The report initiates coverage with an OUTPERFORM rating for BeiGene [2]. Core Views - BeiGene is positioned as a leading innovator in China's biopharmaceutical sector, with a strong focus on oncology treatments and a robust pipeline of over 60 clinical projects globally [3][11]. - The company is expected to achieve profitability by 2025, driven by significant revenue growth from its core products, particularly the BTK inhibitor, Zanubrutinib, which is projected to double its revenue in 2024 [4][20]. - BeiGene's global commercialization capabilities and a well-established management team are key competitive advantages that will support its growth trajectory [12][29]. Summary by Sections 1. Innovative Product Globalization - BeiGene has a diverse product pipeline and aims to become the first biopharma company to achieve consistent profitability [11]. - The company has 17 commercialized products, including Zanubrutinib and Tislelizumab, with strong sales performance in the US and Europe [20]. - Revenue for 2024 is projected at $3.81 billion, a 55% increase year-over-year, with significant contributions from the US market [20]. 2. Leadership in Hematology - The combination of BTK inhibitors and BCL-2 inhibitors is expected to solidify BeiGene's leadership in hematological malignancies [5]. - Zanubrutinib has shown superior efficacy compared to Ibrutinib, establishing its best-in-class status [5][24]. - The company is also developing Sonratoclax, a BCL-2 inhibitor, which is anticipated to enhance its market position [5]. 3. Expansion in Solid Tumors - BeiGene is actively expanding its presence in solid tumors, with Tislelizumab gaining traction in various indications [11]. - The company is developing next-generation CDK inhibitors targeting a market exceeding $10 billion [11]. - Focus areas include lung cancer and breast cancer, with ongoing clinical trials for multiple candidates [11]. 4. Financial Projections and Valuation - Revenue forecasts for FY25-27 are $5 billion, $6 billion, and $6.7 billion, respectively, with a CAGR of 21% [7]. - The net profit is expected to turn positive by FY25, reaching $390 million by FY26 [7]. - The target price is set at HK$182.35, based on a DCF model with a WACC of 9% and a perpetual growth rate of 4% [7].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HK$208.22, indicating a potential upside of 25% from the current price of HK$166.70 [1][6]. Core Insights - The company's revenue for 2024 is projected to reach US$3.81 billion, representing a year-on-year growth of 55.96%. The GAAP net loss is expected to narrow to US$568 million, a 53% improvement compared to the previous year [1]. - Global sales of the drug Zepzelca are anticipated to drive strong growth, with sales reaching US$2.6 billion in 2024, a 104.9% increase year-on-year. The U.S. market sales are expected to grow by 106.3% to US$2 billion, while European sales are projected to increase by 194% to US$359 million [2]. - The company is optimistic about 2025, forecasting revenue between US$4.9 billion and US$5.3 billion, a year-on-year growth of 29% to 39%, and aims to achieve operational breakeven [2]. Financial Summary - The company’s financial data for the years 2022 to 2026 shows a significant increase in revenue, with projections of US$4.9 billion in 2025 and US$5.8 billion in 2026. The gross profit is expected to rise to US$3.86 billion in 2025 [4]. - The net profit is projected to turn positive in 2025, with an expected net income of US$137 million, compared to a loss of US$554 million in 2024 [4]. - The earnings per share (EPS) is expected to improve from a loss of US$0.40 in 2024 to a profit of US$0.10 in 2025 [4].

Investment Rating - The report maintains a "Buy" rating for the company, 百济神州 (6160 HK), with a target price raised to HKD 208.80, indicating a potential upside of 25.3% from the current price of HKD 166.70 [1][4][14]. Core Insights - The company is experiencing rapid growth in the U.S. market for its product, Zebutine, which has become the leading treatment for new patients with chronic lymphocytic leukemia (CLL) [2][7]. - The company expects to achieve positive operating profit in 2025, with projected revenues of USD 4.9 to 5.3 billion and a gross margin in the range of 80-90% [7][8]. - The financial forecasts for 2025 have been adjusted upwards, with revenue estimates increased to USD 5.078 billion, reflecting a 10% increase from previous estimates [8]. Financial Overview - Revenue projections for the years 2023 to 2027 are as follows: - 2023: USD 2.459 billion - 2024: USD 3.810 billion - 2025E: USD 5.078 billion - 2026E: USD 6.208 billion - 2027E: USD 7.155 billion - The company anticipates a net profit of USD 59 million in 2025, with significant growth expected in subsequent years [3][15]. - The operating profit is projected to turn positive in 2025, reaching USD 152 million, with a notable increase to USD 931 million by 2026 [8][15]. Market Performance - The stock has shown a year-to-date increase of 52.66%, with a 52-week high of HKD 166.70 and a low of HKD 77.00 [6][14]. - The average daily trading volume is reported at 13.65 million shares, indicating strong market interest [6]. Product Pipeline and Future Prospects - The company is advancing its pipeline, particularly in the hematology sector, with key developments expected in the coming years, including potential accelerated approvals for new treatments [7]. - The global peak sales forecast for Zebutine has been raised to USD 6.9 billion, reflecting the product's strong market position and growth potential [7][8].

Investment Rating - The report maintains a "Buy" rating for the company, 百济神州 (6160 HK), with a target price raised to HKD 208.80, indicating a potential upside of 25.3% from the current price of HKD 166.70 [1][4][14]. Core Insights - The company is experiencing rapid growth in the U.S. market for its product, Zevulunib, which has become the leading treatment for new patients with chronic lymphocytic leukemia (CLL) [2][7]. - The company expects to achieve positive operating profit by 2025, with projected revenues of USD 4.9-5.3 billion and a gross margin in the range of 80-90% [7][8]. - The financial forecasts for 2025 and 2026 have been adjusted upwards, with revenue estimates increased to USD 5.078 billion and USD 6.208 billion, respectively [8][9]. Financial Overview - Revenue is projected to grow significantly from USD 2.459 billion in 2023 to USD 5.078 billion in 2025, reflecting a year-on-year growth of 73.7% in 2023 and 55.0% in 2024 [3][15]. - The company is expected to achieve a net profit of USD 59 million in 2025, transitioning from a loss of USD 882 million in 2023 [3][15]. - The gross profit margin is expected to remain strong, with estimates of 85.0% in 2025 and 86.0% in 2026 [8][15]. Market Performance - The stock has shown a year-to-date increase of 52.66%, with a 52-week high of HKD 166.70 and a low of HKD 77.00 [6][14]. - The average daily trading volume is reported at 13.65 million shares, indicating strong market interest [6]. Product Pipeline and Future Prospects - The company is advancing its pipeline with significant developments in the treatment of blood cancers and solid tumors, including potential accelerated approvals for new therapies [7][8]. - The global peak sales forecast for Zevulunib has been raised to USD 6.9 billion, reflecting the product's strong market position and growth potential [7][9].

Investment Rating - The report maintains a "Buy" rating for the company and raises the target price to USD 324 for US stocks, HKD 194 for Hong Kong stocks, and CNY 273 for A-shares [1][11]. Core Insights - The company's revenue guidance for 2025 is stronger than market expectations, reaffirming the GAAP operating profit guidance [1][3]. - The company achieved a product revenue of USD 1.118 billion in Q4 2024, representing a year-over-year increase of 77.3% and a quarter-over-quarter increase of 12.5% [2]. - The adjusted non-GAAP operating profit for Q4 2024 was USD 78.6 million, marking the third consecutive quarter of profitability [2]. - The strong overseas sales of the drug Zebutinib contributed to a gross margin of 85.6% in Q4 2024, an increase of 2.4 percentage points year-over-year [2]. Revenue Guidance - The total product revenue guidance for 2025 is set at USD 4.9-5.3 billion, reflecting a year-over-year growth of 29.6% to 40.2%, which exceeds both Visible Alpha's expectation of 27% and the previous forecast of 21% [3]. - GAAP operating expenses are projected to be USD 4.1-4.4 billion, aligning with market expectations [3]. Product Performance - Zebutinib's global sales reached USD 828 million in Q4 2024, showing a year-over-year growth of 100.5% and a quarter-over-quarter growth of 20% [4]. - The US sales of Zebutinib amounted to USD 616 million, a 96.7% increase year-over-year, while European sales reached USD 113 million, up 147.8% year-over-year [4]. Research and Development Progress - The company is expected to have multiple research catalysts in 2025, including the announcement of global phase II data for Sonrotoclax in the second half of 2025 [5][10]. - The company plans to initiate several phase III clinical trials in 2025 for various indications [10]. Financial Projections - Revenue projections for 2025 are estimated at USD 4.972 billion, with a year-over-year growth of 30.5% [12][16]. - The company is expected to achieve a net profit of USD 81 million in 2025, transitioning from a loss in previous years [12][16].

Financial Performance - In Q4 2024, total global revenue reached $1.1 billion, a 78% year-over-year increase, while total global revenue for the year reached $3.8 billion, a 55% year-over-year increase[9]. - In Q4 2024, product revenue reached $1,118,035, a 77% increase from $630,526 in Q4 2023[40]. - Total revenue for the year 2024 was $3,810,241, compared to $2,458,779 in 2023, reflecting a 55% year-over-year growth[40]. - Adjusted operating profit for Q4 2024 was $78,603, compared to a loss of $267,224 in Q4 2023, marking a 129% improvement; annual adjusted operating profit was $45,356, up from a loss of $752,473 in 2023[10]. - Net loss for Q4 2024 was $(151,881), compared to $(367,553) in Q4 2023, indicating a reduction in losses[40]. - For the full year 2024, GAAP net loss was $0.47 per share for common stock and $6.12 per ADS, an improvement from $0.65 and $8.45 in the previous year[32]. - Operating cash flow in Q4 2024 was $75 million, an increase of $297 million year-over-year, while the full year cash used in operations was $141 million, a decrease of $1 billion compared to the previous year[32]. Product Sales - Sales of Baiyueze® in Q4 2024 amounted to $828 million, a 100% year-over-year increase, with total sales for the year reaching $2.6 billion, a 105% year-over-year increase[9]. - Sales of Baiyueze® in the US for Q4 2024 were $616 million, a 97% year-over-year increase, with annual sales reaching $2 billion, up 106%[12]. - Baiyueze® sales in Europe for Q4 2024 were $113 million, a 148% increase year-over-year, with annual sales of $359 million, up 194%[12]. - Bai Ze An® sales for Q4 2024 were $154 million, a 20% increase year-over-year, with annual sales of $621 million, up 16%[15]. - Baiyueze® has been approved in over 70 markets globally, with more than 180,000 patients treated[11]. Research and Development - Six new molecular entities (NMEs) entered clinical development in Q4 2024, with a total of 13 for the year; multiple innovative solid tumor projects are expected to have data readouts in the first half of 2025[9]. - The company is leveraging its research and development platforms, including multispecific antibodies and antibody-drug conjugates, to accelerate future treatments in breast cancer, lung cancer, and gastrointestinal cancer[9]. - The company has a robust pipeline with over 1,800 patients enrolled in clinical trials for various indications, including R/R CLL and R/R MCL[17]. - The company plans to read out data from a Phase 3 study of Tarlatamab for small cell lung cancer in H1 2025[20]. - The company expects to enter clinical development for BG-60366 in Q4 2024, targeting EGFR mutations with strong efficacy[20]. Operational Expenses - R&D expenses for Q4 2024 were $542 million, a 10% increase from $494 million in Q4 2023, while annual R&D expenses reached $1.95 billion, up 10% from $1.78 billion[28][30]. - SG&A expenses for Q4 2024 were $505 million, a 21% increase from $418 million in Q4 2023, with annual SG&A expenses totaling $1.83 billion, also up 21% from $1.51 billion[28][30]. - Total GAAP operating expenses for 2024 reached $3,784,351, up from $3,286,595 in 2023, representing a 15.1% increase[49]. - Adjusted sales and marketing expenses for 2024 were $1,549,864, compared to $1,284,689 in 2023, reflecting a 20.7% increase[49]. Future Outlook - The company expects full-year 2025 revenue guidance to be between $4.9 billion and $5.3 billion, while reaffirming expectations for positive GAAP operating profit and positive cash flow from operations[9]. - The company anticipates strong growth in 2025, positioning it as a pivotal year for its operations[9]. - The company projects total revenue for 2025 to be between $4.9 billion and $5.3 billion, driven by strong growth from the product 百悦泽® in the U.S. and continued expansion in Europe and other key markets[33]. - GAAP operating expenses for 2025 are expected to be between $4.1 billion and $4.4 billion, with a projected gross margin in the range of 80% to 90%[33]. - The earnings call for Q4 2024 and full year results will be held on February 27, 2025, at 8 AM EST[34]. Corporate Developments - The company plans to utilize its new English name "BeOne" and has activated the new stock code ONC on NASDAQ[9]. - The company will change its NASDAQ ticker from "BGNE" to "ONC" pending shareholder approval[25]. - The company plans to submit a marketing application for Baiyueze® tablet formulation to the FDA and EU in the second half of 2025[16]. - The company has signed a settlement agreement with MSN Pharmaceuticals, allowing them to sell a generic version of Baiyueze® in the US no earlier than June 15, 2037[12]. - The company plans to present key data at the 2024 ASH annual meeting and the 2025 J.P. Morgan Healthcare Conference[25]. Strategic Focus - The company emphasizes its leadership position in the chronic lymphocytic leukemia (CLL) treatment market with Baiyueze®[9]. - The company emphasizes a data-driven strategy to maximize resource utilization and prioritize promising clinical candidates[14]. - 百济神州 is focused on developing innovative oncology drugs and enhancing drug accessibility and affordability globally[35]. - The company plans to utilize various social media platforms for significant disclosures in compliance with U.S. fair disclosure regulations[36]. - Forward-looking statements include expectations for future revenue, operating profit, cash flow, and gross margin, with actual results subject to various risks and uncertainties[37].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HK$208.22, representing a potential upside of 76% from the current price of HK$118.20 [3][4]. Core Insights - The company is advancing towards profitability by enhancing its market position and R&D capabilities, with a focus on reducing drug development costs through an internal clinical team [1][2]. - The company has a robust pipeline with significant potential, including key commercial products and a strong internal R&D pipeline consisting of 25 Phase I projects, 8 Phase II projects, and 7 Phase III projects [2][5]. - Financial performance is improving, with expectations of positive GAAP operating profit in 2025, driven by effective cost control and a reduction in reliance on CROs [2][5]. Summary by Sections Investment Rating - The company is rated as "Buy" with a target price of HK$208.22, corresponding to a 5.8x sales multiple for 2025 [3][4]. Market Position and R&D Strength - The company has established a global internal clinical development team of 3,600 members, significantly reducing reliance on CROs from 77% in 2019 to 5% in 2024 [1]. - Strategic focus areas for 2025 include consolidating leadership in hematology, accelerating internal pipeline development, and enhancing financial performance [1]. Pipeline and Product Potential - The key commercial product, Zebutini, is the first BTK inhibitor in the U.S. and shows excellent efficacy in treating blood cancers [2]. - The company’s pipeline includes high-potential early-stage candidates such as CDK4i and panKRASi, which are expected to drive future growth [2]. Financial Performance - In Q2 2024, the company achieved Non-GAAP profitability, and by Q3 2024, it recorded positive operating cash flow for the first time [2]. - The company forecasts a positive GAAP operating profit for the full year of 2025, supported by effective cost management strategies [2][5]. Key Financial Data - Projected revenues are expected to grow from US$2,459 million in 2023 to US$4,904 million in 2025, with a net profit turning positive in 2025 at US$137 million [4][12]. - The company’s gross profit is projected to increase from US$2,080 million in 2023 to US$3,857 million in 2025, indicating strong growth potential [4][12].

Investment Rating - The report assigns a "Buy" rating to the company with a target price of HKD 159.00, indicating a potential upside of 38.0% from the current closing price of HKD 115.20 [7]. Core Insights - The company has shown strong sales growth in Q3 2024, with total revenue increasing by 28.2% year-on-year to USD 1.002 billion, driven primarily by a 66.9% increase in product revenue to USD 993 million [1]. - The sales of the drug Zebutinib reached USD 690 million globally, marking a 93.0% year-on-year increase, with a notable performance in the U.S. market [1][2]. - The adjusted non-GAAP operating profit for Q3 2024 was USD 65.63 million, marking the second consecutive quarter of positive operating profit [1]. - The company is expected to continue facing accelerated depreciation costs in Q4 2024, but profitability is anticipated to improve as product volumes increase in the following year [1]. Financial Forecast Changes - Revenue forecasts for 2024-2026 have been increased by 6-7%, with peak sales for Zebutinib revised up by 4% to USD 5.4 billion [2]. - The new revenue projections for 2024, 2025, and 2026 are USD 3.712 billion, USD 4.630 billion, and USD 5.566 billion, respectively, reflecting a 7% increase for 2024 [3]. - The gross profit for 2024 is projected at USD 3.108 billion, with a gross margin of 83.6% [3]. Key Developments - The report highlights several upcoming catalysts, including potential approvals for additional indications of the drug Tarelizumab in key markets and the initiation of Phase III studies for the Bcl-2 inhibitor sonrotoclax in early 2025 [2]. - The company is also advancing multiple candidates for solid tumors into clinical stages, with eight candidates already in clinical trials this year [2]. Financial Data Overview - The company reported a net loss of USD 698 million for 2024, with expectations of narrowing losses in subsequent years [8]. - Cash and cash equivalents are projected to decrease to USD 2.551 billion in 2024, with a gradual recovery expected in 2025 [8].