[Financial Highlights](index=1&type=section&id=Financial%20Highlights) BeiGene achieved significant revenue growth in Q1 2024, with total revenues reaching $751.7 million, while substantially reducing operational losses and improving efficiency Financial Performance Summary (in millions USD) | Financial Metric | Q1 2024 | Q1 2023 | % Change | | :--- | :--- | :--- | :--- | | Net product revenues | $746.9 | $410.3 | 82% | | Total Revenue | $751.7 | $447.8 | 68% | | GAAP loss from operations | $(261.3) | $(371.3) | (30)% | | Adjusted loss from operations* | $(147.3) | $(275.9) | (47)% | - The company's strong global revenue growth has elevated it into the **top 15 of global oncology innovators** based on total oncology sales[2](index=2&type=chunk) - BeiGene is demonstrating significantly improved operating leverage and is progressing on its path to achieving **sustainable profitability**[1](index=1&type=chunk)[2](index=2&type=chunk) [Key Business & Pipeline Updates](index=1&type=section&id=Key%20Business%20%26%20Pipeline%20Updates) Key products BRUKINSA and TEVIMBRA show strong commercial growth and regulatory approvals, while the pipeline advances rapidly in hematology and solid tumors [BRUKINSA (zanubrutinib)](index=1&type=section&id=BRUKINSA%20%28zanubrutinib%29) BRUKINSA revenue reached $489 million in Q1 2024 with strong U.S. and European growth, securing its fifth FDA approval for R/R follicular lymphoma BRUKINSA Revenue by Region (in millions USD) | Region | Q1 2024 Revenue | YoY Growth | | :--- | :--- | :--- | | **Total** | **$489** | - | | U.S. | $351 | 153% | | Europe | $67 | 243% | - Received U.S. FDA approval for treating adult patients with relapsed or refractory (R/R) follicular lymphoma, establishing BRUKINSA with the **broadest label in the BTKi class**[1](index=1&type=chunk)[5](index=5&type=chunk) - BRUKINSA is gaining market share in treatment-naïve (TN) chronic lymphocytic leukemia (CLL) and has become the **BTKi class leader in new-patient share** for relapsed or refractory (R/R) CLL in the U.S.[4](index=4&type=chunk) [TEVIMBRA (tislelizumab)](index=2&type=section&id=TEVIMBRA%20%28tislelizumab%29) TEVIMBRA sales grew 26% to $145 million in Q1 2024, securing key regulatory approvals in Europe and the U.S. for NSCLC and ESCC - Sales of tislelizumab totaled **$145 million** in Q1 2024, representing **26% growth** compared to the prior-year period[5](index=5&type=chunk) - Key regulatory approvals were secured: - **European Commission:** Approved for three indications in non-small cell lung cancer (NSCLC) - **U.S. FDA:** Approved for second-line esophageal squamous cell carcinoma (ESCC) - **U.S. FDA:** Accepted Biologics License Application (BLA) for first-line gastric or gastroesophageal junction cancers[5](index=5&type=chunk) [Key Pipeline Highlights](index=2&type=section&id=Key%20Pipeline%20Highlights) The pipeline shows strong progress in hematology with sonrotoclax and BGB-16673, and in solid tumors with multiple readouts and new assets entering the clinic in H2 2024 - **Hematology Pipeline:** - **Sonrotoclax (BCL2 inhibitor):** Received FDA fast track designation for R/R mantle cell lymphoma (MCL) and continues enrollment for registrational intent trials - **BGB-16673 (BTK CDAC):** Initiated expansion cohorts with potential registrational intent in R/R MCL and R/R CLL, with a Phase 3 trial in R/R CLL expected by year-end 2024[6](index=6&type=chunk) - **Solid Tumor Pipeline:** - **Lung Cancer:** Completed enrollment in a Phase 3 trial for ociperlimab (anti-TIGIT) and expects readouts for multiple tislelizumab combinations in 2024 - **Breast Cancer:** Progressing dose escalation for CDK4 and CDK2 inhibitors and dosed the first patient in a Phase 1 study for B7H4 ADC - **New Assets:** Pan-KRAS inhibitor, MTA-cooperative PRMT5 inhibitor, EGFR CDAC, CEA-ADC, and FGFR2b-ADC are on track to enter the clinic in H2 2024[6](index=6&type=chunk)[7](index=7&type=chunk)[8](index=8&type=chunk) [Detailed Financial Performance](index=4&type=section&id=Detailed%20Financial%20Performance) Q1 2024 saw an 82% product revenue increase to $747 million and improved gross margin, with operating leverage gains leading to a reduced net loss per share [Revenue and Gross Margin](index=4&type=section&id=Revenue%20and%20Gross%20Margin) Total Q1 2024 revenue reached $752 million, driven by an 82% increase in product revenue to $747 million, with gross margin improving to 83% - Total Q1 2024 revenue was **$752 million**, with product revenue contributing **$747 million**, an **82% increase** from Q1 2023[10](index=10&type=chunk) - The U.S. was the largest market, with product revenue of **$351 million**, a **153% increase** from the prior year period[10](index=10&type=chunk) - Gross margin as a percentage of global product revenue increased to **83%** in Q1 2024 from **80%** in Q1 2023, mainly due to a higher sales mix of global BRUKINSA[11](index=11&type=chunk) [Operating Expenses and Profitability](index=4&type=section&id=Operating%20Expenses%20and%20Profitability) Total GAAP operating expenses rose 20% to $888.1 million, but improved operating leverage led to a 30% reduction in GAAP loss from operations and a reduced net loss per share Operating Expenses (GAAP, in millions USD) | Expense Category | Q1 2024 | Q1 2023 | % Change | | :--- | :--- | :--- | :--- | | Research and development | $460.6 | $408.6 | 13% | | Selling, general and administrative | $427.4 | $328.5 | 30% | | **Total operating expenses** | **$888.1** | **$737.3** | **20%** | - The increase in operating expenses was due to advancing preclinical and early clinical programs (R&D) and continued investment in the global commercial launch of BRUKINSA (SG&A)[12](index=12&type=chunk)[13](index=13&type=chunk) - Profitability metrics improved, with GAAP Net Loss decreasing to **$251.2 million** from **$348.4 million** in Q1 2023. Net loss per share improved to **$(0.19)** from **$(0.26)**[13](index=13&type=chunk)[14](index=14&type=chunk)[19](index=19&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) The condensed consolidated financial statements detail a net loss of $251.2 million for Q1 2024, with total assets of $5.7 billion and total equity of $3.4 billion [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2024, total revenues were $751.7 million, resulting in a gross profit of $626.7 million and a net loss of $251.2 million, or $(0.19) per share Condensed Consolidated Statements of Operations (in thousands USD) | (in thousands of U.S. dollars) | Three Months Ended March 31, 2024 | | :--- | :--- | | Total revenues | $751,652 | | Gross profit | $626,717 | | Loss from operations | $(261,348) | | **Net loss** | **$(251,150)** | | Net loss per share, basic and diluted | $(0.19) | [Condensed Consolidated Balance Sheet](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheet) As of March 31, 2024, BeiGene reported $2.8 billion in cash and equivalents, with total assets of $5.7 billion and total equity of $3.4 billion Condensed Consolidated Balance Sheet (in thousands USD) | (in thousands of U.S. dollars) | As of March 31, 2024 | | :--- | :--- | | Cash, cash equivalents, restricted cash and short-term investments | $2,807,436 | | Total assets | $5,667,681 | | Total liabilities | $2,307,320 | | Total equity | $3,360,361 | [Non-GAAP Financial Measures](index=9&type=section&id=Non-GAAP%20Financial%20Measures) Non-GAAP financial measures provide additional insight into operating performance by excluding non-cash items, with adjusted loss from operations at $147.3 million for Q1 2024 - BeiGene uses non-GAAP financial measures to provide a more complete understanding of its operating performance by excluding non-cash items such as share-based compensation, depreciation, and amortization[22](index=22&type=chunk) Reconciliation of GAAP to Adjusted Loss from Operations (in thousands USD) | Reconciliation of GAAP to Adjusted Loss from Operations (in thousands) | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | GAAP loss from operations | $(261,348) | $(371,258) | | Plus: Share-based compensation expenses | $88,714 | $75,388 | | Plus: Depreciation | $24,110 | $19,025 | | Plus: Amortization of intangibles | $1,183 | $986 | | **Adjusted loss from operations** | **$(147,341)** | **$(275,859)** |

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]

Core Insights - BeiGene announced a new matching adjusted indirect comparison (MAIC) showing BRUKINSA (zanubrutinib) has advantages in progression-free survival and complete response over acalabrutinib in relapsed or refractory chronic lymphocytic leukemia (CLL) [1][2] - The analysis will be presented at the 28th Annual International Congress on Hematologic Malignancies in Miami from February 29 to March 3 [1] Efficacy Comparison - The MAIC indicates that BRUKINSA shows improved investigator-assessed progression-free survival with a hazard ratio (HR) of 0.77 (95% CI: 0.55-1.07) in the unadjusted population and HR of 0.68 (95% CI: 0.46-0.99) in the adjusted population [3] - The odds ratio (OR) for complete response favored BRUKINSA with OR of 2.88 (95% CI: 1.18-7.02) in the unadjusted population and OR of 2.90 (95% CI: 1.13-7.43) in the adjusted population [3] Study Methodology - The MAIC matched individual patient-level data from the ALPINE trial against aggregate data from the ASCEND trial, using an unanchored MAIC due to the absence of a common comparator arm [2] - Adjustments were made for key patient characteristics and the impact of COVID-19 on study outcomes [2] Previous Limitations Addressed - The new MAIC addresses significant limitations found in a previously published MAIC, including the exclusion of final analysis data from ALPINE and lack of adjustment for COVID-19 impacts [3] BRUKINSA's Market Position - BRUKINSA is the only BTK inhibitor demonstrating progression-free survival superiority compared to ibrutinib in R/R CLL, as shown in the ALPINE trial [3] - The drug is approved in 70 markets globally, including the U.S., China, and EU, and is under development for additional indications [4] Development Program - The global development program for BRUKINSA includes over 5,000 subjects enrolled across 29 countries and regions [5]

Investment Rating - Maintain BUY rating for BeiGene, indicating strong potential for over 15% return in the next 12 months [2][4]. Core Insights - BeiGene is expected to have a productive 2024, driven by strong sales momentum of zanubrutinib, which recorded total product sales of US$631 million in 4Q23, reflecting a 6% quarter-over-quarter (QoQ) and 86% year-over-year (YoY) increase [2]. - Zanubrutinib's sales reached US$1.29 billion in full-year 2023, with a forecast of US$1.9 billion for 2024, representing a 46% YoY growth [2]. - The company is advancing its pipeline with potential blockbusters like sonrotoclax and BGB-16673, with multiple Phase 3 studies expected to start in 2024 [2]. - BeiGene's financial health is improving, with a gross profit margin of 82.7% in FY23, up from 77.2% in FY22, and a significant reduction in the SG&A ratio [2]. Financial Summary - Total revenue for FY23 was US$2.459 billion, with a projected increase to US$2.902 billion in FY24 [3][17]. - Net loss for FY23 was US$882 million, expected to decrease to US$1.1 billion in FY24 and further to US$225 million in FY25, with profitability anticipated from FY26 [2][3]. - The company had US$2.3 billion in net cash at the end of 2023, indicating no immediate need for further equity financing [2]. Target Price - The target price for BeiGene has been revised from US$295.67 to US$268.20, indicating a 67% upside potential from the current price of US$160.26 [4].

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 accepted a Biologics License Application (BLA) for TEVIMBRA® (tislelizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. T ...

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today reinforced its continued global expansion, rapid global and U.S. revenue growth, and innovative R&D strategy with the presentation of results from the fourth quarter and full year 2023 and business highlights. “BeiGene made great progress in the fourth quarter and full year 2023 toward our goal to become an impactful next-generation oncology innovator. ...

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications: In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatm ...