The speed of growth of a given stock is much higher the smaller it is. Stock size is classified by market capitalization – current share price x number of shares outstanding – with large cap shares being above $10 billion. Generally speaking, once a stock reaches large cap status its growth prospects decline substantially.Thus, it’s generally unreasonable to anticipate 50% returns over a year when it comes to large cap stocks. And while it may be generally unreasonable, it is not impossible.Each of the larg ...

BeiGene, Ltd. (BGNE) is a next-gen oncology company focusing on discovering and developing innovative and affordable treatments for cancer patients worldwide.The company currently markets three internally discovered oncology products, including BTK inhibitor, Brukinsa (zanubrutinib), in the United States, China, the EU, the United Kingdom and additional international markets. BeiGene markets its other products like anti-PD-1 antibody, tislelizumab, in the EU and China, and PARP inhibitor, pamiparib, only in ...

浦银国际研究 公司研究 | 医药行业 百济神州 （BGNE.US/6160.HK/688235.CH）： 阳景 海外泽布替尼收入带动 1Q24 业绩好于预期 浦 首席医药分析师 银 维持“买入”评级和目标价：美股 275 美元，港股 165 港元，A 股人 Jing_yang@spdbi.com 国 (852) 2808 6434 民币 175元。 际  受益于泽布替尼海外销售超预期，1Q24 产品收入和净亏损好于预期： 1Q24 实现总收入 7.52亿美元（+67.9% YoY, +18.5% QoQ），包括产品收 胡泽宇 CFA 入 7.47 亿美元（+82% YoY, +18.5% QoQ），明显好于我们预期和彭博一 医药分析师 致预期，主要受泽布替尼海外销售显著强于预期、替雷利珠单抗及安 ryan_hu@spdbi.com 进产品销售好于预期驱动；净亏损为 2.51 亿美元（-27.9% YoY, -31.7% (852) 2808 6446 QoQ），低于我们预期和彭博一致预期，主要受益于收入强于预期及规 模效应下研发费用率、销售行政费用率进一步降低。一季度经调整Non- 2024年5月9日 GA ...

Investment Rating - Maintain BUY rating for BeiGene, reflecting strong growth potential and robust pipeline [2][4][16] Core Insights - BeiGene's product sales in 1Q24 reached US$747 million, showing an 18% quarter-over-quarter increase and an 82% year-over-year increase, representing 25.7% of the previous FY24 estimate [2] - Zanubrutinib (zanu) sales were particularly strong, increasing 18% QoQ and 131% YoY to US$489 million, driven by market share gains in CLL in the US and expanded reimbursement in the EU [2] - The company is on track to achieve profitability, with expectations to break even by FY26E, supported by improving operating margins and narrowing net losses [2][3] Summary by Sections Product Sales Performance - Total product sales for BeiGene in 1Q24 were US$747 million, up 18% QoQ and 82% YoY [2] - Zanubrutinib captured approximately 21% of the global BTK inhibitor market in 1Q24, up from 18% in 4Q23 [2] Patent Dispute - A patent dispute with Pharmacyclics is nearing resolution, with the USPTO expected to issue a final decision on the validity of the contested patent within 12 months [2] Financial Performance - Gross profit margin improved to 83.3% in 1Q24 from 82.7% in FY23, driven by high-margin product sales [2] - Net loss narrowed to US$251 million in 1Q24 from US$368 million in 4Q23, better than expectations [2][3] Future Growth Potential - Upcoming clinical trials for sonrotoclax and BGB-16673 are expected to yield significant data, with potential blockbuster status anticipated [2] - Forecast for zanubrutinib sales in FY24 is US$2.2 billion, representing a 69% YoY increase [2] Target Price Adjustment - The DCF-based target price for BeiGene has been raised from US$268.20 to US$269.73, indicating a potential upside of 59.9% from the current price of US$168.64 [4][12]

Financial Performance - Total revenues reached $752 million in Q1 2024, with product revenue of $747 million, marking an 82% increase from the prior year[119] - Gross profit increased to $626.7 million, a 71.2% rise from $366 million in the same quarter last year[126] - Net loss narrowed to $251.2 million, a 27.9% improvement from a loss of $348.4 million in Q1 2023[126] - Net product revenue increased by 82.0% to $746.9 million for the three months ended March 31, 2024, compared to $410.3 million in the prior-year period[130] - Global sales of BRUKINSA totaled $488.5 million in the first quarter, representing a 131.1% increase compared to the prior-year period[131] - U.S. sales of BRUKINSA grew by 153.3% to $351.5 million, while European sales increased by 242.8% to $66.8 million[131] - Sales of tislelizumab in China totaled $145.2 million, reflecting a 26.4% increase from the prior-year period[132] - Gross margin on global product sales increased to $622.0 million, with a gross margin percentage of 83.3% for the three months ended March 31, 2024[135] Expenses and Losses - Operating expenses totaled $888.1 million, up 20.5% from $737.3 million, driven by increased research and development costs[126] - Research and development expenses rose by 12.7% to $460.6 million, driven by higher development milestone fees and internal research activities[136] - Selling, general and administrative expenses increased by 30.1% to $427.4 million, primarily due to investments in commercial activities[139] - The company reported a net loss of $251.2 million for the three months ended March 31, 2024, compared to a net loss of $348.4 million for the same period in 2023, resulting in an accumulated deficit of $8.2 billion as of March 31, 2024[147] Revenue Sources - BRUKINSA generated $489 million in revenue, with growth of 153% in the U.S. and 243% in Europe compared to the prior year[119] - Collaboration revenue decreased by 87.4% to $4.7 million, primarily due to the termination of the Novartis collaborations[127] Regulatory Approvals - The European Commission approved tislelizumab for non-small cell lung cancer across three indications[120] - The FDA approved TEVIMBRA for the treatment of unresectable or metastatic esophageal squamous cell carcinoma, expected to be available in the U.S. in the second half of 2024[120] - BRUKINSA received its fifth indication in B-cell malignancies in the U.S. after FDA granted accelerated approval for relapsed or refractory follicular lymphoma[122] Cash Flow and Debt - Cash and cash equivalents decreased to $2.8 billion as of March 31, 2024, down from $3.5 billion at the end of the previous year, with net cash used in operating activities amounting to $308.6 million in Q1 2024[151] - The company utilized $209.8 million in investing activities during the three months ended March 31, 2024, primarily for capital expenditures of $156.6 million and IPR&D asset purchases of $31.8 million[155] - Financing activities generated $162.3 million in cash during Q1 2024, mainly from $142.0 million in short-term loans and $9.1 million from long-term loans[157] - Total debt increased to $1,025.99 million as of March 31, 2024, up from $885.98 million at the end of 2023[145] - The company has total debt obligations of $1.03 billion, with $827.0 million due within the next 12 months[168] Foreign Currency and Inflation - The impact of foreign currency translation negatively affected cash by $22.4 million in Q1 2024, compared to a positive impact of $11.3 million in the prior-year period[159] - The RMB depreciated approximately 1.7% against the U.S. dollar in the three months ended March 31, 2024, and approximately 2.8% in the year ended December 31, 2023[176] - The company has not used derivative financial instruments to hedge exposure to foreign exchange risk despite holding significant amounts of RMB[175] - Inflation has not had a material effect on the company's results of operations during the three months ended March 31, 2024[179] Future Outlook and Commitments - The company plans to fund its material cash requirements through existing financial resources and anticipated receipts from accounts receivable and product sales[163] - As of March 31, 2024, the company had a remaining co-development funding commitment of $457.0 million related to the Amgen collaboration[170] - The company expects to refinance its debt obligations based on historical experience, with the ability to do so influenced by prevailing interest rates and credit spreads[157] - The company expects to utilize its existing RMB cash deposits in its China operations over the next several years[175] Accounting Policies - The company continues to evaluate its critical accounting policies, with no material changes reported for the three months ended March 31, 2024[173] - The company has not reported any new accounting policies adopted during the three months ended March 31, 2024[173] - The company assesses various factors for estimating the useful lives of long-lived assets and the fair value of financial instruments, which may lead to differences from actual results[172] - The company is exposed to risks related to changes in interest rates and foreign currency exchange rates, which may impact its financial condition[174][176]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________ Form 8-K ______________________ CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event Reported): April 26, 2024 BEIGENE, LTD. (Exact Name of Registrant as Specified in Charter) Cayman Islands 001-37686 98-1209416 (State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification Number) c/o Mourant Governance ...

Company Overview - BeiGene, Ltd. is a global oncology company focused on developing innovative cancer treatments, with a commitment to improving access to medicines for patients worldwide [29]. FDA Approval - The U.S. FDA has approved TEVIMBRA® (tislelizumab-jsgr) as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor, with availability expected in the U.S. in the second half of 2024 [1][8]. Clinical Trial Results - The approval of TEVIMBRA is based on the RATIONALE 302 trial, which demonstrated a statistically significant survival benefit, with a median overall survival of 8.6 months for TEVIMBRA compared to 6.3 months for chemotherapy (p=0.0001; HR=0.70) [2][4]. - The trial involved 512 patients across 132 research sites in 11 countries, highlighting the global reach of the study [4]. Market Potential - Esophageal cancer is projected to see nearly 957,000 new cases by 2040, indicating a 60% increase from 2020, emphasizing the need for effective treatments [5]. - TEVIMBRA has been prescribed to over 900,000 patients globally, showcasing its potential impact on cancer treatment [3]. Future Developments - The FDA is currently reviewing Biologics License Applications (BLAs) for tislelizumab as a first-line treatment for unresectable, recurrent, locally advanced, or metastatic ESCC, with target action dates set for July and December 2024 [3].

Company Overview - Pi Health is an oncology-focused health technology and clinical research company that aims to transform global access to innovative medicines and clinical trials [1] - The company was incubated as a subsidiary of BeiGene, Ltd. and has recently completed over $30 million in Series A funding to launch as an independent entity [1][5] - The funding round was led by AlleyCorp and Obvious Ventures, with additional investments from Invus Capital and global oncology leaders [1] Industry Challenges - The clinical trial system is characterized by low participation rates, with less than 8% of eligible cancer patients participating in studies, limiting understanding of the disease across diverse populations [2] - Current clinical trials infrastructure is inefficient, relying on outdated methods such as Excel spreadsheets and manual data entry, which complicates the process [4] Technological Innovation - Pi Health has developed FICS (Front-End Interoperable Capture Software), a comprehensive software solution that connects life science sponsors and trial sites, automating manual processes for faster and higher-quality data collection [4] - The software integrates generative AI to streamline clinical documentation, patient matching, data transformations, and adverse event monitoring, significantly reducing administrative burdens [5] Market Potential - The implementation of Pi Health's platform is expected to revolutionize the clinical trial system, enabling faster and more efficient delivery of life-saving drugs and treatments to patients [5] - The Series A funding will support the expansion of partnerships with global trial sites and life sciences companies, as well as further development of the FICS technology [5][6] Global Reach - Pi Health has established partnerships with oncology centers across the US, Brazil, Australia, and India, including a new cancer hospital in Hyderabad, India, to promote equitable access to clinical trials [7]

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BRUKINSA® (zanubrutinib) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), in combination with the anti-CD20 monoclonal antibody obinutuzumab, after two or more lines of systemic therapy. The indication is approved u ...

Core Insights - BeiGene, Ltd. is presenting emerging oncology pipeline data at the AACR Annual Meeting, showcasing its commitment to developing innovative cancer treatments [1][2][7] - The company has nine abstracts scheduled for poster presentations, focusing on various combinations of tislelizumab and other novel candidates [1][2] Pipeline Developments - Results from the AdvanTIG-204 Phase 2 study of tislelizumab plus ociperlimab in limited-stage small cell lung cancer (SCLC) will be presented, along with biomarker study results in first-line non-small cell lung cancer (NSCLC) [1][2] - An ongoing global Phase 3 trial (AdvanTIG-302) of ociperlimab plus tislelizumab in stage IV, PD-L1 high NSCLC is set to complete enrollment this month [1] - A Phase 1a dose escalation study of BGB-10188, a PI3Kδ inhibitor, in combination with tislelizumab will also be presented [1][2] Novel Molecules and Combinations - Preclinical characterizations of several novel molecules, including a CEA x 4-1BB bispecific antibody and a chimeric degradation activation compound (CDAC) targeting BTK, will be showcased [2] - Clinical data from a Phase 1 study of BGB-16673 in relapsed/refractory B-cell malignancies demonstrated clinical responses and a tolerable safety profile [2] - A triple-combination therapy of tislelizumab with anti-LAG-3 and anti-TIM-3 is being evaluated in a Phase 2 study for head and neck squamous cell carcinoma [2] Presentation Schedule - The presentations will cover various studies, including the correlation between BTK degradation and tumor growth inhibition, and the efficacy of ociperlimab plus tislelizumab in NSCLC [3][4] - Specific abstracts include a first-in-human Phase 1a study of BGB-10188 and a Phase 2 study evaluating LBL-007 in combination with tislelizumab [4][5][6] Company Overview - BeiGene is focused on discovering and developing affordable and accessible cancer treatments globally, with a diverse pipeline of novel therapeutics [7] - The company has a global team of over 10,000 employees and operates in multiple regions, including Basel, Beijing, and Cambridge [7]