Financial Data and Key Metrics Changes - Total revenue grew by 19% in the first half of 2025, driven by increased recurring revenue [4][29] - Operating profit increased by 56%, reflecting strong financial performance despite strategic investments [5][33] - Cash reserves at the end of the first half were approximately $3 billion, providing flexibility for growth and expansion [5][29] - Recurring revenues represented 97% of total revenue, up from 90% in the same period last year [31] Business Line Data and Key Metrics Changes - Sales for Epkinley reached $211 million, a 74% year-over-year increase, contributing significantly to total revenue growth [22][29] - TIVDAC sales totaled $78 million, a 30% increase compared to the previous year, with strong performance in the US and Japan [26][29] - The growth of commercialized medicines is expected to increasingly contribute to overall revenue growth over time [21][29] Market Data and Key Metrics Changes - Epkinley has received regulatory approvals in over 60 countries, with nearly 50 countries approving it for both DLBCL and FL indications [24][29] - The FDA accepted the supplemental BLA for epiritamab with a target action date of November 30, 2025, indicating strong market potential [7][55] Company Strategy and Development Direction - The company aims to accelerate the development of high-impact late-stage programs and maximize the potential of commercialized medicines [4][39] - Plans to broaden the reach of RINA S with three Phase III trials expected to be underway by the end of the year [10][39] - The company is focused on expanding utilization of its medicines and bringing them to more patients globally [28][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future, highlighting a strong financial foundation and disciplined capital allocation strategy [5][37] - The company anticipates continued growth in recurring revenues and operating profit, with improved financial guidance for 2025 [34][35] - Management is closely monitoring geopolitical situations but does not foresee significant impacts on financial guidance for 2025 [37] Other Important Information - The company completed a share buyback in June, reinforcing confidence in its future [5] - The Phase III Epcor FL1 trial met its dual endpoints, supporting the potential to transform treatment paradigms for patients [12][14] Q&A Session Summary Question: Positioning of EPCO versus other CD20 bispecifics - Management feels confident about their broad and aggressive development plan, with a head start in second-line follicular lymphoma [43][44] - They have received positive feedback from physicians and are moving into earlier lines of therapy [47][48] Question: Confidence in filing RAINFALL-one for accelerated approval - Management is confident in filing for accelerated approval based on strong data and ongoing engagement with the FDA [54][55] Question: Initial launch strategy for Epkinley - The focus will be on earlier lines of therapy, particularly in the community setting, with significant opportunities for patient expansion [62] Question: Development plans for RINA S outside ovarian cancer - The Phase II trial will explore RINA S in both monotherapy and combination settings, with a focus on EGFR mutated non-small cell lung cancer [93] Question: ADC combinations in lymphoma - Management sees potential for ADC combinations and believes bispecifics will become a backbone for novel combinations in the future [87][88]

Summary of the Conference Call for BeiGene (1Q25) Company Overview - **Company**: BeiGene - **Industry**: Biotechnology/Pharmaceuticals Key Financial Performance - **1Q25 Revenue**: - Net product sales reached **$1.109 billion**, representing a **48% year-over-year increase** [1] - **Zebutinib Global Sales**: **$792 million**, with a **62% year-over-year increase** [1] - **U.S. Sales**: **$563 million**, up **60% year-over-year** [1] - **European Sales**: **$116 million**, up **73% year-over-year** [1] - **Tislelizumab Sales**: **$171 million**, reflecting an **18% year-over-year increase** [1] - **GAAP Net Profit**: Achieved a net profit of **$1.27 million**, marking the first quarterly profit [1] Strategic Developments - **Investor R&D Day**: Scheduled for **June 26**, focusing on breast cancer and other solid tumor pipelines [1] - **Reimbursement Expansion**: Zebutinib has been included or expanded in reimbursement in **11 markets**, including Japan, Europe, and Brazil [1] - **New Supplier**: Engaged **Siegfried** as a new supplier for active pharmaceutical ingredients for Zebutinib [1] - **Regulatory Filings**: BCL2 has been submitted for approval in China for the treatment of R/R CLL [1] - **Clinical Trials**: - Initiated a Phase III clinical trial for BTKCDAC in treating R/R CLL, comparing against physician's choice of treatment [1] - DLL3/CD3 bispecific antibody (in collaboration with Amgen) reported positive data from the Phase III trial for 2L SCLC [1] - CDK4 is expected to report Proof of Concept data in the first half of 2025 [1] Additional Insights - The significant growth in Zebutinib sales is attributed to its increasing market share in the treatment of new CLL patients, positioning it as the top seller in the U.S. BTK market [1]

Financial Data and Key Metrics Changes - UroGen Pharma reported net product revenues of $90.4 million for the full year 2024, an increase from $82.7 million in 2023, representing a year-over-year growth of approximately 9.3% [17][44] - The net loss for the fourth quarter of 2024 was $37.5 million, or $0.80 per share, compared to a net loss of $26 million, or $0.72 per share, in the same period in 2023 [47] - For the full year 2024, the net loss was $126.9 million, or $2.96 per share, compared to a net loss of $102.2 million, or $3.55 per share, in 2023 [47] Business Line Data and Key Metrics Changes - JELMYTO generated net product revenues of $24.6 million in Q4 2024, up from $23.5 million in Q4 2023, with underlying demand revenue increasing by 15% [44] - The underlying demand revenue for JELMYTO for the full year 2024 was $87.4 million, reflecting a 12% increase compared to the previous year [39][44] - The company reported a compelling complete response rate of 79.6% at three months and an 82.3% duration of response at 12 months for UGN-102, with updated data showing an 80.6% duration of response at 18 months [9][10] Market Data and Key Metrics Changes - The total addressable market for UGN-102 is estimated to be over $5 billion, significantly larger than the market for JELMYTO [15] - The anticipated launch of UGN-102 is expected to transform UroGen's market position, moving from a rare disease-focused company to a multiproduct specialty-driven team [34] Company Strategy and Development Direction - UroGen aims to enhance its commercial infrastructure by expanding its sales force from 52 to approximately 83 representatives to support the launch of UGN-102 [37][100] - The company is focused on raising awareness of unmet needs in low-grade intermediate risk non-muscle invasive bladder cancer through educational programs and scientific exchanges [35][36] - UroGen has acquired ICVB-1042, a next-generation investigational oncolytic virus, to enhance its pipeline and address critical gaps in cancer care [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the data package submitted for UGN-102 and its potential to address significant unmet needs in the bladder cancer treatment landscape [14] - The company anticipates a transformative year in 2025 with the expected launch of UGN-102, which is projected to generate over $1 billion in revenue [54][109] - Management highlighted the importance of preparing for reimbursement processes and ensuring smooth integration of UGN-102 into treatment protocols [38][66] Other Important Information - UroGen ended 2024 with a strong balance sheet, holding $241.7 million in cash, cash equivalents, and marketable securities [21][43] - The company expects full-year 2025 JELMYTO revenues to be in the range of $94 million to $98 million, indicating a growth rate of approximately 8% to 12% [48] Q&A Session Summary Question: Can UGN-102 be used off-label for patients ineligible for surgery? - Management indicated that using UGN-102 in this context would be considered off-label, and it would be up to physicians to work with insurance companies for reimbursement [53][54] Question: How should investors think about the initial launch trajectory of UGN-102? - The launch trajectory is expected to be similar to JELMYTO, with a larger patient population leading to higher absolute numbers [61][72] Question: What are the expected differences in reimbursement levels with the J-code transition? - Initially, a miscellaneous J-code will be used, which may result in longer reimbursement times, but this will improve with a unique permanent J-code expected in January 2026 [66][68] Question: How will UGN-102 be positioned relative to UGN-103? - UGN-102 is expected to be phased out after UGN-103 is approved, with a focus on ensuring no automatic substitution occurs [94][95] Question: What is the rationale behind increasing the sales force size? - The increase is based on patient epidemiology, ensuring coverage of approximately 85% of the market for low-grade intermediate risk NMIBC [102][104]