美股代码：BGNE A 股代码：688235 A 股简称：百济神州 港股代码：06160 港股简称：百济神州 百济神州有限公司 投资者关系活动记录表 （2024 年 8 月） 投资者关系 √特定对象调研 □分析师会议 □媒体采访 □业绩说明会 活动类别 □新闻发布会 √路演活动 □现场参观 □一对一沟通 √其他（电话会议） 参与单位 3w 、 Ariose Capital 、 Balyasny Asset Management 、 Boyu 及人员 Captial 、 Capital Group 、 CSOP Asset Management 、 CTI Capital 、 Franklin Templeton Investments 、 Guotai Junan Assets Asia、HSBC GAM、IDG Capital、Invesco、Janchor Partners、Marshall Wace、New Silk Road、Point 72、SPDBI、Tiger Pacific Capital、安信基 金、奥昇投资、彼得明奇资管、财通资管、淳厚基金、大家资产、丹羿 投资、淡马锡、淡水泉投资、道翼资 ...

Investment Rating - The report maintains a "Buy" rating for the company, with a target price of HKD 156.00, indicating a potential upside of 42.9% from the current price of HKD 109.20 [7]. Core Insights - The company has turned profitable in Q2 2024, reporting an adjusted non-GAAP operating profit of USD 48 million, a significant improvement from a loss of USD 193 million in Q2 2023. The operating cash outflow has narrowed to USD 404 million [1]. - The strong performance is attributed to the rapid growth in global sales of the drug Zebrutinib, which increased by 107% year-on-year and 30% quarter-on-quarter to USD 637 million, with U.S. sales growing by 114% year-on-year [1]. - The report projects an increase in the peak global sales forecast for Zebrutinib from USD 4.4 billion to USD 5.2 billion [1]. Financial Projections - Revenue projections for 2024-2026 have been raised by 13-18%, reflecting a more optimistic outlook on Zebrutinib sales and adjustments in gross margin and operating expense forecasts [2]. - The expected revenues are USD 3.463 billion for 2024, USD 4.366 billion for 2025, and USD 5.252 billion for 2026, with corresponding year-on-year growth rates of 40.8%, 26.1%, and 20.3% respectively [3][8]. - The company is expected to achieve a net profit of USD 410 million by 2026, compared to a projected loss of USD 762 million in 2024 [3][8]. Key Financial Metrics - The gross profit margin is expected to improve to 86.0% by 2026, up from 84.1% in 2024 [8]. - The report indicates a significant reduction in operating expenses, with R&D and SG&A expense ratios decreasing to 49% and 48% respectively by 2024 [1]. - The company’s cash flow situation is projected to improve, with free cash flow expected to turn positive by 2025 [6].

医药生物 2024 年 08 月 08 日 百济神州 (688235) ——泽布替尼高速增长，二季度非 GAAP 经营利润盈利 | --- | |---------------------| | 2024 年 08 月 07 日 | | 137.50 | | 163.88/98.50 | | 7.8 | | - | | 15,820 | | 2,869.83/8,449.58 | | | | --- | --- | |--------------------------|---------------------| | 基础数据: | 2024 年 03 月 31 日 | | 每股净资产（元） | 17.76 | | 资产负债率% | 40.51 | | 总股本/流通 A 股（百万） | 1,376/115 | | 流通 B 股/H 股（百万） | -/1,261 | 一年内股价与大盘对比走势： 08-0709-0710-0711-0712-0701-0702-0703-0704-0705-0706-0707-0708-07 -40% -20% 0% 20% 40% 60% 百济神州 沪深300指数 (收益率 ...

Investment Rating - The report maintains a "Buy" rating for the company and raises the target price to USD 285, HKD 171, and CNY 181 [1][3]. Core Insights - The company's Q2 2024 performance significantly exceeded expectations, primarily driven by strong sales growth of Zebutinib in the US and Europe. The company achieved its first adjusted Non-GAAP operating profit, marking a positive surprise in this earnings report [1]. - Total revenue for Q2 2024 reached USD 929 million, representing a year-over-year increase of 56.1% and a quarter-over-quarter increase of 23.6%. Product revenue was USD 921 million, up 66.3% year-over-year and 23.2% quarter-over-quarter, significantly surpassing expectations [1]. - Zebutinib's global sales reached USD 637 million, with US sales at USD 479 million, reflecting a year-over-year increase of 114.4% and a quarter-over-quarter increase of 36.3%. The management indicated that Zebutinib has captured over 40% market share in the CLL indication in the US [1][3]. Summary by Sections Financial Performance - The company reported a net loss of USD 120 million for Q2 2024, a decrease of 68.4% year-over-year and 52.1% quarter-over-quarter, which was better than expectations due to stronger product revenue and higher gross margins [1]. - The overall product gross margin reached 85% in Q2 2024, up 2.3 percentage points year-over-year and 1.7 percentage points quarter-over-quarter [1]. Research and Development Progress - The company is focusing on key pipeline projects, including Sonrotoclax (BCL2) and BGB-16673 (BTK CDAC), with ongoing clinical trials and expected data readouts in late 2024 and early 2025 [1][3]. - The management anticipates further improvements in gross margins and a reduction in R&D and administrative expense ratios as Zebutinib sales continue to grow [1]. Market Position and Strategy - The company announced a relocation of its registered office from the Cayman Islands to Switzerland, reflecting its global strategic expansion [3]. - The establishment of a large-scale production facility in New Jersey is now operational, which will support the supply of its products in the US and Europe [3].

Investment Rating - The report maintains a "Buy" rating for BeiGene, with a target price adjustment from $269.73 to $288.93 [2][18]. Core Insights - BeiGene's product sales exceeded expectations, recording $921 million in Q2 2024, representing a 23% quarter-over-quarter growth and a 66% year-over-year increase [1][2]. - The company achieved non-GAAP profitability, with a significant reduction in net loss to $120 million in Q2 2024 from $251 million in Q1 2024 [2][3]. - Strong sales momentum for Zanubrutinib (Zanu) was noted, with Q2 sales reaching $637 million, a 30% increase quarter-over-quarter and a 107% increase year-over-year [1][2]. Financial Performance - Total product sales for the first half of 2024 reached $1.67 billion, accounting for 51.4% of the previously estimated total for fiscal year 2024 [1][2]. - The gross profit margin increased to 85.0% in Q2 2024 from 83.3% in Q1 2024, driven by a higher proportion of high-margin sales [2][3]. - The SG&A ratio decreased to 48% in Q2 2024 from 57% in Q1 2024, indicating improved operational efficiency [2][3]. Market Position and Growth Potential - Zanu captured approximately 24% of the global BTK inhibitor market in Q2 2024, up from 20% in Q1 2024, with expectations to reach $2.6 billion in sales for FY24, a 102% year-over-year increase [2][3]. - The report highlights the potential of upcoming clinical trials for Sonrotoclax and BGB-16673, which are expected to drive future growth [2][3]. Future Projections - The company is projected to achieve breakeven in FY25E, supported by strong sales growth and improving operating margins [2][3]. - Revenue estimates for FY24E, FY25E, and FY26E are $3.87 billion, $5.49 billion, and $6.99 billion, respectively, with a focus on continued product sales growth [3][12].

Summary of Conference Call Records Company and Industry Overview - The conference call involved executives from a biopharmaceutical company, focusing on their recent financial performance and research developments in the oncology sector, particularly in the context of innovative drug development and market expansion. Key Financial Performance - The company reported a record product revenue of 11.91 billion CNY (approximately 1.19 billion USD) for the first half of 2024, representing a year-on-year growth of 77.8% [1] - In Q2 2024, the company achieved an adjusted operating profit of 345 million CNY (approximately 34.5 million USD), marking a significant improvement from a loss of 1.78 billion CNY (approximately 178 million USD) in Q1 2024 [1] - The global sales revenue for the core product, Zebutinib, reached 1.126 billion USD in H1 2024, with a year-on-year increase of 117% [1] - Q2 2024 revenue for Zebutinib was 637 million USD, showing a year-on-year growth of 107% and a quarter-on-quarter growth of 30% [1] - The company’s revenue from the Chinese market for the product Tislelizumab was 303 million USD in H1 2024, reflecting a 15% increase year-on-year [1] Product Performance and Market Expansion - Zebutinib's sales in the U.S. for Q2 2024 were 479 million USD, a 114% increase year-on-year and a 36% increase quarter-on-quarter, driven by expanded usage in Chronic Lymphocytic Leukemia (CLL) [1] - In Europe, Zebutinib's revenue reached 81 million USD in Q2 2024, with a year-on-year growth of 209% [1] - Tislelizumab has received multiple approvals in the EU for various indications, with 11 indications included in the national medical insurance directory in China [1] - The company is advancing its pipeline with promising early-stage data for investigational products Sonrotoclax and BGB-16673, with ongoing clinical trials expected to enroll participants in late 2024 or early 2025 [1] Research and Development Insights - The company has positioned itself as a leader in the field of oncology, particularly in the development of innovative therapies for hematological malignancies [3] - The R&D pipeline includes multiple new molecular entities entering clinical trials, with a focus on breast cancer and other solid tumors [4] - The company has completed the first patient enrollment in a Phase III trial for Sonrotoclax in combination with Zebutinib for treating TN CLL patients [1][4] Strategic Initiatives and Future Outlook - The company has relocated its registration from the Cayman Islands to Basel, Switzerland, to enhance its international presence and operational efficiency [2] - The management emphasized cost control measures, with a focus on reducing sales expense ratios while maintaining growth in product volume [6] - Future product launches include BTK inhibitors and BCL-2 inhibitors, with several applications expected in the next 2-3 years [7] - The company remains optimistic about the biopharmaceutical industry, viewing it as a sunrise sector despite challenges, and is committed to developing innovative therapies to improve patient outcomes [7] Additional Noteworthy Points - The company’s gross margin improved by 2 percentage points, attributed to increased market share and pricing strategies in the U.S. and EU [2] - The company has completed significant investments in manufacturing facilities in the U.S. and China, which are now operational [6] - The management highlighted the importance of collaboration with international partners to maximize the potential of their products [7]

Investment Rating - Maintain BUY rating for BeiGene, reflecting strong product growth momentum and near-term profitability [1][2][9] Core Insights - BeiGene's product sales in 2Q24 reached US$921 million, a 23% increase quarter-over-quarter and a 66% increase year-over-year, exceeding expectations [1] - The company achieved non-GAAP profitability with a net loss narrowed to US$120 million in 2Q24, compared to US$251 million in 1Q24, marking a significant milestone [1] - Forecasts indicate that BeiGene's zanubrutinib (zanu) will generate US$2.6 billion in sales for FY24, representing a 102% year-over-year increase, with peak sales projected at US$5.6 billion by 2031 [1] Summary by Sections Sales Performance - Total product sales for 1H24 reached US$1.67 billion, representing 51.4% of the previous FY24 estimate [1] - Zanubrutinib sales increased by 30% quarter-over-quarter and 107% year-over-year to US$637 million, capturing approximately 24% of the global BTK inhibitor market [1][2] Profitability Metrics - Gross profit margin improved to 85.0% in 2Q24 from 83.3% in 1Q24, driven by high-margin product sales and economies of scale [1] - The SG&A ratio decreased to 48% in 2Q24 from 57% in 1Q24, while the R&D ratio shrank to 49% from 62% in the previous quarter [1] Future Growth Potential - The company is advancing clinical trials for sonrotoclax and BGB-16673, which are expected to become future blockbusters [1] - Phase 3 trials for sonrotoclax in R/R CLL and R/R MCL are anticipated to start in late 2024 and early 2025, respectively [1] Financial Projections - Revenue projections for FY24E are set at US$3.87 billion, with net profit expected to turn positive in FY25E at US$53.4 million [2][10] - Target price raised from US$269.73 to US$288.93, indicating a potential upside of 57.9% from the current price of US$183.03 [2][9]

Investment Rating - The report maintains an "Overweight" rating for BeiGene [2][4]. Core Insights - The company's operational performance exceeded expectations, with a significant increase in product revenue and a narrowing of net losses. The core product, Zebrutinib, is experiencing rapid growth in the US and is entering a harvest phase in Europe [4][5]. - The company achieved product revenue of $921 million in Q2 2024, representing a year-on-year increase of 66.3%. The net loss for Q2 2024 was $120 million, a reduction from a loss of $381 million in the same period last year [5]. - The report highlights the ongoing optimization of operational efficiency, with non-GAAP operating profit reaching $48 million, marking a turnaround from previous losses [5]. Financial Summary - For 2024, the company is projected to achieve revenues of $3.645 billion, with forecasts for 2025 and 2026 adjusted to $4.440 billion and $5.044 billion, respectively [5]. - The gross profit for 2024 is expected to be $3.033 billion, with a significant improvement in net profit projected for 2025 at $145 million [5]. - The report notes a decrease in SG&A and R&D expenses as a percentage of total revenue, indicating improved operational efficiency [5]. Pipeline Development - The report outlines several ongoing clinical trials, including potential registrations for Sonrotoclax and various other therapies, with multiple data readouts expected in 2024 [5]. - The company is advancing its pipeline with several candidates entering clinical stages, including a range of antibody therapies and inhibitors targeting various cancers [5].

Financial Performance - Total revenues for Q2 2024 reached $929 million, a 56% increase from $595 million in Q2 2023[120] - Product revenue, net, was $921 million, reflecting a 66.3% increase from $554 million in the prior year[124] - Global BRUKINSA revenues amounted to $637 million, a 107% increase compared to the same period last year[120] - GAAP operating loss was reduced to $107 million, a 66.4% improvement from a loss of $319 million in Q2 2023[124] - Non-GAAP operating income was achieved, indicating improved operational efficiency[120] - Total revenue increased to $1,680.8 million, or 61.1%, for the six months ended June 30, 2024, from $1,043.1 million for the same period in 2023[138] - The company reported a net loss of $371.6 million for the six months ended June 30, 2024, compared to a net loss of $729.6 million for the same period in 2023[158] - Cash used in operating activities was $404.2 million for the six months ended June 30, 2024, primarily due to the net loss and an increase in net operating assets and liabilities of $268.8 million[163] Revenue Breakdown - Collaboration revenue decreased by 80.7% to $8 million, primarily due to the termination of the Novartis collaborations[125] - U.S. sales of BRUKINSA totaled $479.4 million in the second quarter, representing growth of 114.4%[128] - BRUKINSA sales in Europe totaled $148.2 million in the six months ended June 30, 2024, representing growth of 223.5% compared to the prior-year period[142] - Sales of tislelizumab in China reached $303.5 million for the six months ended June 30, 2024, a 14.8% increase from $264.3 million in the prior-year period[143] - Sales of Amgen products in China totaled $162.0 million for the six months ended June 30, 2024, compared to $85.7 million in the prior-year period, driven primarily by increased XGEVA sales volume[143] Expenses - Research and development expenses increased by 7.5% to $454 million, reflecting ongoing investment in innovative therapies[124] - Selling, general and administrative expenses increased by $48.7 million, or 12.3%, to $443.7 million for the three months ended June 30, 2024[134] - Research and development expenses rose by $83.8 million, or 10.1%, to $915.1 million for the six months ended June 30, 2024, compared to $831.3 million in the prior-year period[146] - Selling, general and administrative expenses increased by $147.6 million, or 20.4%, to $871.2 million for the six months ended June 30, 2024, from $723.5 million in the prior-year period[148] Cash and Debt - As of June 30, 2024, total cash and cash equivalents were $2,617.9 million, down from $3,186.0 million as of December 31, 2023[156] - As of June 30, 2024, the company had cash and cash equivalents of $2.6 billion, down from $3.4 billion at the end of June 2023, reflecting a net decrease of $568.1 million in cash during the six months[162][163] - Total debt obligations due within the next 12 months amount to $851.7 million, with total long-term debt obligations at $185.3 million[179] - The company has a co-development funding commitment of $412.6 million related to the Amgen collaboration, with a total cap of $1.25 billion for global development costs[181] Foreign Exchange and Inflation - The impact of foreign currency exchange rates negatively affected cash by $28.3 million in the first half of 2024, compared to a negative impact of $50.9 million in the prior-year period[170] - The RMB depreciated approximately 2.2% against the U.S. dollar in the six months ended June 30, 2024, and approximately 2.8% in the year ended December 31, 2023[186] - The company is exposed to foreign exchange risk due to operating transactions and assets in currencies other than the U.S. dollar[185] - Inflation has not had a material effect on the company's results of operations during the six months ended June 30, 2024[189] - The company has not experienced significant impacts from inflation on labor and clinical trial costs during the reporting period[189] Operational Developments - A new U.S. facility was opened in Hopewell, New Jersey, enhancing manufacturing and clinical research capabilities[121] - The innovative solid tumor pipeline includes over 15 investigational molecules targeting various cancer types[120] - The company advanced pivotal programs for BCL2 inhibitor sonrotoclax and BTK-targeted degrader BGB-16673[120] Interest Income and Other Financials - Interest income, net decreased by $1.8 million, or 12.2%, to $13.2 million for the three months ended June 30, 2024[135] - Interest income decreased by $1.7 million, or 5.5%, to $29.4 million for the six months ended June 30, 2024, due to lower interest rates on cash and cash equivalents[150] - Other expense, net decreased to $10.2 million for the six months ended June 30, 2024, from $45.5 million in the prior-year period, primarily due to foreign exchange losses[151] - Income tax expense decreased to $22.2 million for the six months ended June 30, 2024, from $25.2 million in the prior-year period[152]

Revenue Performance - Total revenue reached $929.17 million, a year-over-year increase of 56%[3] - Product revenue net amounted to $921.15 million, reflecting a 66% growth compared to $553.75 million in the same quarter last year[4] - Total revenue for the six months ended June 30, 2024, was $1.68 billion, a 61% increase from $1.04 billion in the same period last year[4] - Total revenue for Q2 2024 was $929 million, compared to $595 million in the same period of 2023, primarily due to the sales increase of Baiyueze® in the US and Europe[13] - Product revenue for Q2 2024 was $921 million, a 66% increase from $554 million in Q2 2023, largely attributed to the sales growth of Baiyueze®[13] Product Sales - Global sales of Baiyueze® reached $637 million, a 107% increase, solidifying its leading position in hematology[3] - In Q2 2024, sales of Baiyueze® in the US reached $479 million, a year-over-year increase of 114%, with over 60% of the quarterly demand growth coming from expanded use in chronic lymphocytic leukemia (CLL) indications[5] - In Q2 2024, sales of Baiyueze® in Europe reached $81 million, a year-over-year increase of 209%, driven by market share gains across all major markets including Germany, Italy, Spain, France, and the UK[5] - Baiyueze® demonstrated a 100% overall response rate in a Phase 3 trial for high-risk CLL patients, with a complete response rate of 48%[5] - Baiyueze® sales in the US reached $479 million in Q2 2024, while sales in China and Bai Za An® also positively impacted product revenue[13] Operating Performance - GAAP operating loss decreased to $107.16 million, down 66% from $318.72 million in the same quarter last year[4] - Adjusted operating profit was $48.46 million, a 125% improvement from a loss of $193.05 million in the same quarter last year[4] - The company achieved an adjusted operating profit of $48 million in Q2 2024, marking a significant turnaround from a GAAP operating loss[16] - GAAP net loss for the quarter ended June 30, 2024, improved to $120,405 from $381,137 in the same quarter last year[20] - The company reported a gross profit of $791,034 for Q2 2024, compared to $499,271 in Q2 2023[20] Expenses - The total operating expenses for Q2 2024 were $898 million, a 10% increase from $818 million in Q2 2023[14] - R&D expenses for the first half of 2024 were $915,104, a 10% increase from $831,348 in the first half of 2023[15] - SG&A expenses for the first half of 2024 reached $871,156, reflecting a 20% increase from $723,533 in the first half of 2023[15] - Total operating expenses for the first half of 2024 amounted to $1,786,260, a 15% increase compared to $1,555,256 in the first half of 2023[15] - The company continues to invest in the global commercialization of its product, particularly in the U.S. and Europe, with SG&A expenses accounting for 48% of product revenue in Q2 2024, down from 71% in the same period last year[16] Strategic Developments - The company is advancing over 15 innovative molecules in its solid tumor pipeline, targeting lung, breast, and gastrointestinal cancers[3] - A flagship biopharmaceutical manufacturing base and clinical R&D center in New Jersey, USA, has been officially launched with an investment of $800 million[3] - The company plans to relocate its registered office from the Cayman Islands to Switzerland to enhance its global development strategy[3] - The company plans to initiate Phase 3 studies for Sonrotoclax in R/R CLL and R/R MCL in Q4 2024 or Q1 2025[7] Financial Position - As of June 30, 2024, total assets decreased to $5,712,179 thousand from $5,805,275 thousand as of December 31, 2023, representing a decline of approximately 1.6%[21] - Cash and cash equivalents decreased to $2,617,931 thousand from $3,185,984 thousand, a reduction of about 17.8%[21] - Total liabilities increased to $2,345,924 thousand from $2,267,948 thousand, marking an increase of approximately 3.4%[21] - Accounts receivable increased to $529,449 thousand from $358,027 thousand, representing a growth of approximately 47.9%[21] - Inventory increased to $443,260 thousand from $416,122 thousand, reflecting a rise of about 6.5%[21] Non-GAAP Measures - The company has established a set of non-GAAP policies to provide a clearer understanding of its operational performance, which includes adjustments for non-cash items[22] - The adjusted operating loss for the six months ended June 30, 2024, was $(98,877) thousand, an improvement from $(468,910) thousand in the same period of 2023[24] - Adjusted R&D expenses for the six months ended June 30, 2024, were $787,949 thousand, compared to $725,431 thousand for the same period in 2023, an increase of approximately 8.6%[23]