Summary of the Conference Call Company Overview - The company, transitioning to B1 Medicines, was founded in February 2010 and has grown to over 11,000 employees globally, focusing on innovative medicines for patients worldwide [5][4] - The company aims to solidify its leadership in hematology, advance its pipeline, and deliver strong financial performance as it moves into 2025 [5][6] Hematology Franchise - B1 Medicines is the only company with three wholly owned, potentially best-in-class medicines for Chronic Lymphocytic Leukemia (CLL) [6] - The lead product, Brukinza, is the only BTK inhibitor to demonstrate complete and sustained BTK inhibition and has shown superiority to IMBRUVICA in head-to-head trials [6][12] - In Q1, the company achieved a revenue share lead in the CLL market just two years post-launch [6][10] - The second asset, Sonro, is a second-generation BCL2 inhibitor, with ongoing Phase III trials and a recent filing for relapsed-refractory CLL in China [7][8] - The third asset is a first-in-class BTK degrader, with over 600 patients dosed and a Phase III trial initiated [8] Financial Performance - The company reported $1.1 billion in sales for Q1, a 50% year-over-year increase, marking its first quarter of GAAP income [9][10] - The financial profile has significantly improved compared to previous years, setting a strong foundation for 2025 [11][21] Market Dynamics and Competition - The company believes in the long-term benefits of fixed-duration therapy for patients, despite competition from Akala [16] - Concerns were raised about the efficacy and safety of competing therapies, particularly regarding patient populations and outcomes [17][18] - The company sees significant opportunities in first-line Mantle Cell Lymphoma (MCL) and other B-cell malignancies, estimating over 20,000 new cases annually across these indications [19][20] Pipeline and R&D Strategy - B1 Medicines had 13 New Molecular Entities (NMEs) enter the clinic last year, the highest in the industry, with 10 proof of concept data readouts expected in 2025 [8][9] - The company is focused on a portfolio approach to manage risks associated with pricing pressures and competition [24] - Upcoming R&D Day on June 26 will highlight the company's strategy to build franchises in key disease areas, including lung cancer and breast cancer [36][39] Regulatory and Approval Insights - The company is pursuing accelerated approval opportunities for Sonro in the U.S. and is engaging with regulatory authorities regarding undetectable MRD rates as a surrogate endpoint [30][31] - The development review committee has clear go/no-go criteria for new molecules, ensuring focus on impactful investigational medicines [40] Commercial Strategy - The company is optimistic about the market potential for Tivimbra, particularly in upper GI cancers, with a global PD-1 market opportunity estimated at $50 billion [46][47] - Tivimbra has received frontline esophageal and gastric labels, with a focus on differentiation and competitive pricing [48][49] Geographic Revenue Diversity - The company has evolved to resemble a global multinational pharma, with significant growth opportunities in Europe and other markets [51][52] Conclusion - B1 Medicines is well-positioned in the hematology market with a strong pipeline and financial performance, while also preparing for future growth in solid tumors and expanding its global presence [53][54]

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Core Insights - BeiGene, Ltd. reported $1.12 billion in revenue for Q1 2025, marking a 48.6% year-over-year increase and an EPS of $1.22 compared to -$2.41 a year ago [1] - The revenue matched the Zacks Consensus Estimate of $1.12 billion, resulting in a slight surprise of -0.65%, while the EPS exceeded expectations with a surprise of +271.83% [1] Financial Performance - Product revenue totaled $1.11 billion, slightly below the estimated $1.12 billion by analysts [4] - Key product revenues included: - BRUKINSA (Zanubrutinib): $791.66 million vs. $820.07 million estimated - Tislelizumab: $171.16 million vs. $171.33 million estimated - XGEVA: $70.42 million vs. $56.55 million estimated - Other: $17.90 million vs. $14.28 million estimated - POBEVCY: $13.75 million vs. $16.11 million estimated - BLINCYTO: $23.91 million vs. $20.42 million estimated - KYPROLIS: $19.73 million vs. $16.51 million estimated - Collaboration revenue was $8.75 million, exceeding the $6.49 million estimate [4] Market Performance - BeiGene's shares have returned +15.4% over the past month, outperforming the Zacks S&P 500 composite's +10.6% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the broader market [3]

Financial Data and Key Metrics Changes - The company achieved GAAP profitability for the first time in Q1 2025, with revenue of $1.1 billion, representing a 49% increase from $752 million in Q1 2024 [37][38] - Non-GAAP net income totaled $136 million in Q1 2025, an increase of $282 million compared to the prior year, equating to non-GAAP earnings of $1.22 per ADS [41][42] - Product gross margin increased to 85% in Q1 2025 from 83% in Q1 2024, driven by favorable mix and cost of sales productivity [40] Business Line Data and Key Metrics Changes - Brukinza sales reached $792 million in Q1 2025, representing a 62% growth compared to Q1 2024, establishing it as the market leader in the U.S. BTK market [38][39] - Tivenbra sales were $171 million, resulting in 18% revenue growth year-over-year, primarily driven by its leading market position in China [39] - The U.S. market grew 60% due to strong demand for Brukinza, while China sales grew by 26% compared to the prior year [16][17] Market Data and Key Metrics Changes - Global sales reached $1.1 billion, with the U.S. being the largest market, growing 60% [16][17] - European sales experienced a 75% growth, driven by the launch of Brukinza and Tivenbra [18] - Sales in the rest of the world totaled $32 million, growing 146% compared to the prior year, primarily due to expansion in new markets [19] Company Strategy and Development Direction - The company focuses on solidifying its hematology franchise leadership, advancing its pipeline of internally developed assets, and driving superior financial performance [6][12] - The company is committed to regional manufacturing to mitigate risks associated with trade policies and tariffs, including an $800 million investment in its New Jersey manufacturing facility [13][14] - The company plans to submit its first global filing for Sonro in the second half of 2025, marking a significant step in its oncology portfolio [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's unique model to succeed despite challenges in the global environment, emphasizing a technology-enabled and vertically integrated organization [12][13] - The company anticipates more than 10 proof of concept readouts across its solid tumor pipeline this year, representing potential near-term value inflection points [11] - Management remains optimistic about the growth prospects in Europe and the rest of the world, expecting these markets to contribute significantly to future revenue growth [18][19] Other Important Information - The company has received approval for redomiciling to Switzerland and changing its name to B1 Medicines, reflecting its evolution into a globally diversified oncology leader [14] - The company has a robust pipeline with 19 new molecules in the clinic across major tumor types, focusing on targeted therapies [34][35] Q&A Session Summary Question: Can you remind us how 4395 differs from Pfizer's Otermo and the potential role of Rekinza in autoimmune diseases? - The company’s CDK4 molecule is designed to be more potent and selective than Pfizer's Otermo, with plans to initiate phase three trials in second-line settings [48][49] Question: Can you provide a sense of Kinza's Q1 performance and split sales by region? - The company noted that the Part D redesign had some impact on pricing, but overall, they experienced a stable net pricing environment [56][58] Question: What are the expectations for the interim analysis of the Mangrove trial? - The Mangrove trial is event-driven, and the company hopes to see results in the second half of the year [78] Question: How does the company view the competitive landscape for Brukinza with upcoming data from competitors? - The company believes that Brukinza will maintain and expand its market share, emphasizing its superior safety and efficacy profile compared to competitors [86][92] Question: What is the company's strategy regarding R&D spending amid a wave of approved concept data? - The company is committed to investing significantly in its pipeline while maintaining a focus on sustainable growth and profitability [93][96]

Q1 2025 Results This presentation is intended for the investor community only; it is not intended to promote the products referenced herein or otherwise influence healthcare prescribing decisions. All trademarks in this presentation are the property of their respective owners. This presentation includes U.S. generally accepted accounting principles ("GAAP") and non-GAAP financial measures. Reconciliations between these two measures are provided in the appendix to this presentation. Some of the clinical data ...

Financial Performance - Total revenues for Q1 2025 increased by 48.6% to $1.117 billion compared to $751.7 million in Q1 2024[94] - BRUKINSA global sales rose by 62.1% to $791.7 million, with U.S. sales growing by 60.2% to $563.2 million[95] - TEVIMBRA revenue increased by 17.8% to $171.2 million in Q1 2025 compared to $145.3 million in the prior-year period[96] - The company achieved GAAP profitability in Q1 2025, marking a significant turnaround from a net loss of $251.2 million in Q1 2024[92] - GAAP net income improved to $1.3 million in Q1 2025, compared to a loss of $251.2 million in the prior-year period[107] - Adjusted earnings per share (basic) for Q1 2025 was $0.10, compared to a loss of $0.11 in Q1 2024[108] Expenses and Costs - Operating expenses rose by 6.0% to $941.2 million, with R&D expenses increasing by 4.6% to $481.9 million[93] - Selling, general and administrative expenses increased by $31.9 million, or 7.5%, to $459.3 million for Q1 2025, primarily due to global commercial expansion efforts[103] - Selling, general and administrative expenses as a percentage of product sales decreased to 41.4% in Q1 2025 from 57.2% in the prior-year period[103] - Research and development expense increased by $21.2 million, or 4.6%, to $481.9 million for Q1 2025 from $460.6 million in Q1 2024[98] - External research and development expenses rose by $19.4 million, or 11.3%, to $190.8 million in Q1 2025, driven by advancing preclinical and early clinical programs[100] Cash and Debt Management - Cash, cash equivalents, and restricted cash totaled $2.53 billion as of March 31, 2025, down from $2.64 billion at the end of 2024[110] - Total debt decreased to $923.6 million as of March 31, 2025, from $1.02 billion at the end of 2024, with $97.1 million paid down in Q1 2025[110] - The company expects to repay approximately $763.5 million of loans in the next 12 months, with refinancing dependent on prevailing interest rates and credit spreads[116] - As of March 31, 2025, total debt obligations due in the next twelve months are $763.5 million, with long-term debt obligations at $160.2 million[123] - The company had $461.6 million in cash remaining related to the STAR Offering proceeds as of March 31, 2025[111] Revenue Sources - Collaboration revenue increased by 84.8% to $8.7 million in Q1 2025, driven by agreements with Novartis and Amgen[96] Operational Highlights - Gross margin on global product sales improved to 85.1% in Q1 2025, up from 83.3% in the same period last year[97] - Cash provided by operating activities improved by $352.7 million in Q1 2025 compared to Q1 2024, driven by significantly improved revenue and a $325.6 million increase in gross margin[113] - Net cash used in investing activities decreased to $121.9 million in Q1 2025 from $209.8 million in Q1 2024, primarily due to reduced capital expenditures[114] - Financing activities used $33.8 million in cash in Q1 2025, a significant decrease from $162.3 million provided in Q1 2024, mainly due to a net reduction in short-term debt borrowings[115] Strategic Initiatives - The company plans to host an Investor R&D Day on June 26, 2025, to discuss advancements in its late-stage pipelines[92] - The company secured shareholder approval to rename itself to BeOne Medicines Ltd. and to redomicile to Switzerland[92] Legal and Regulatory Developments - The U.S. Patent and Trademark Office invalidated all claims of Pharmacyclics LLC's U.S. Patent No. 11,672,803, benefiting the company's competitive position[89] Foreign Exchange Impact - The RMB appreciated approximately 0.6% against the U.S. dollar in Q1 2025, while it depreciated approximately 2.8% in the year ended December 31, 2024[132] - A hypothetical 10% appreciation in the U.S. dollar against the RMB would have resulted in an increase in foreign exchange loss of approximately $14.8 million as of March 31, 2025[133]

Financial Reporting - BeiGene, Ltd. filed its 2024 Annual Report with the STAR Market of the Shanghai Stock Exchange on April 28, 2025[5]. - The STAR Annual Report includes financial information for the year ended December 31, 2024, prepared in accordance with PRC GAAP[6]. - Financial information prepared under U.S. GAAP is also included, highlighting differences between PRC GAAP and U.S. GAAP[6]. - The financial information in the report is intended to be furnished and not deemed "filed" under the Exchange Act[8]. Key Financial Metrics - The report contains details on gross profit margin ratio and research and development expenses allocated by key products[6]. Public Availability - The STAR Annual Report is publicly available in Chinese on the Shanghai Stock Exchange's website[7]. Strategic Insights - The report does not include any new product launches or market expansion strategies[5][6]. - No specific performance guidance or future outlook was provided in the current report[5][6]. - The report does not mention any mergers or acquisitions during the reporting period[5][6]. Signatory Information - The filing was signed by Chan Lee, Senior Vice President and General Counsel of BeiGene, Ltd.[16].

Core Viewpoint - BeiGene Ltd has announced the discontinuation of its clinical development program for ociperlimab (BGB-A1217), an anti-TIGIT antibody, for lung cancer treatment based on a recommendation from the Independent Data Monitoring Committee following a futility analysis [1][2][3]. Group 1: Clinical Trial Details - The Phase 3 AdvanTIG-302 trial was evaluating the efficacy and safety of ociperlimab in combination with tislelizumab compared to Merck's Keytruda (pembrolizumab) in adults with high PD-L1, locally advanced/recurrent, or untreated metastatic non-small cell lung cancer (NSCLC) [2]. - The overall efficacy and safety data indicated that the trial was unlikely to meet its primary endpoint of overall survival [2][3]. - The study was originally expected to conclude in February 2027 [3]. Group 2: Company Strategy and Future Plans - BeiGene's decision to terminate the trial reflects a strategic evaluation of its clinical programs, focusing resources on the most promising candidates while deprioritizing others [3]. - No new safety signals were observed during the trial, which contributed to the decision to discontinue [3]. Group 3: Market Reaction - Following the announcement, BeiGene's stock (ONC) experienced a decline of 4.2%, trading at $263.04 [4].

Core Insights - BeiGene Ltd announced FDA approval for Tevimbra (tislelizumab-jsgr) in combination with platinum-containing chemotherapy for first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [1] - The approval is based on the results from the RATIONALE-306 Phase 3 study, which demonstrated a statistically significant improvement in overall survival (OS) for patients treated with Tevimbra compared to placebo [2][3] Study Results - The RATIONALE-306 study met its primary endpoint, showing a median OS of 16.8 months for patients treated with Tevimbra plus chemotherapy versus 9.6 months for those on placebo plus chemotherapy, resulting in a 34% reduction in the risk of death [3] - The improvement in OS was primarily observed in the subgroup of patients with PD-L1 expression ≥1 [2] Previous Approvals - In December, the FDA also approved Tevimbra for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1, based on the RATIONALE-305 Phase 3 trial [4] - The RATIONALE-305 study showed a median OS of 15.0 months for patients treated with Tevimbra compared to 12.9 months for those on placebo, resulting in a 20% reduction in the risk of death [5] Market Reaction - Following the announcement, BeiGene's stock (ONC) was observed to be up 3.04% at $253 during the premarket session [5]