Financial Data and Key Metrics Changes - Total revenue grew 9% year over year to $110 million in Q2 2025, primarily driven by higher sales of VIBGART and ZACTURA [34] - Operating loss improved by 28% to $54.9 million, while adjusted loss from operations was reduced by 37% to $34.2 million [17][35] - The company reaffirmed its full year revenue guidance of $560 million to $590 million, expecting profitability on an adjusted basis in Q4 2025 [7][36] Business Line Data and Key Metrics Changes - VIBGART saw record levels of patient utilization, with a meaningful shift toward maintenance use, reflecting growing physician confidence [12] - Zejula experienced a softer quarter due to evolving competitive dynamics but is expected to stabilize and grow in the second half of the year [15] - Zakduro continues to see robust demand, although supply constraints may limit near-term growth [16] Market Data and Key Metrics Changes - The new national guidelines for gMG in China elevate VIBGART's positioning, recognizing minimal symptom expression as the primary treatment goal [13] - Approximately 450,000 patients with gastric cancer in China, with about one-third overexpressing FGFR2b, represent a significant market opportunity for bemarituzumab [39] Company Strategy and Development Direction - The company aims to become a leading global biopharma, focusing on commercial business growth and advancing its global pipeline [6] - Strategic priorities include strengthening the global pipeline with externally sourced innovation and expanding the China portfolio with best-in-class assets [18] - The company is leveraging AI to optimize clinical trials and enhance commercial analytics [10] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue guidance and profitability goals by year-end, driven by VIBGART and other products [46][47] - The company anticipates significant long-term potential for VIBGART, with expectations of exceeding $1 billion in peak sales [15][71] Other Important Information - The company is preparing for submissions for several late-stage assets, including bemarituzumab and tumor treating fields for pancreatic cancer [17] - The cash position at the end of the quarter was $832.3 million, indicating a strong financial position [36] Q&A Session Summary Question: Potential opportunity for bemarituzumab in frontline gastric cancer - Management highlighted a significant patient population in China, with over 450,000 gastric cancer patients, and expressed confidence in achieving over $1 billion in sales potential [39][40] Question: Confidence in achieving 2025 revenue guidance and profitability - Management reaffirmed confidence in the revenue guidance and profitability, expecting accelerating growth in the second half of the year driven by VIBGART [46][47] Question: Growth expectations from broader commercial franchise - Management indicated that both Zakduro and Onctyro are expected to contribute to growth, with strong demand anticipated [54][56] Question: Steps left to file bemarituzumab in China - Management is focused on expediting the submission process and is in discussions with partners for registration [87][89] Question: Timeline for DLL3 ADC data updates - Management expects to provide updates on the second-line treatment data before the end of the year, with first-line data likely in early next year [95]

Financial Data and Key Metrics Changes - Total revenue grew 9% year over year to $110 million in the second quarter, primarily driven by higher sales of VIBGART and ZACTURA [32][33] - Operating loss improved by 28% to $54.9 million, while adjusted loss from operations was reduced by 37% to $34.2 million, keeping the company on track to achieve profitability in the fourth quarter [15][33] Business Line Data and Key Metrics Changes - VIBGART saw record levels of patient utilization, with a meaningful shift toward maintenance use, reflecting growing physician confidence [10][11] - Zejula had a softer quarter due to evolving competitive dynamics but is expected to stabilize and grow in the second half of the year [13][47] - Zakduro continues to see robust demand, although supply constraints may limit near-term growth [14] Market Data and Key Metrics Changes - VIBGART penetration in gMG is currently at 10%, indicating significant room for growth [11] - The new national guidelines for gMG in China elevate VIBGART's positioning, recognizing its ability to achieve minimal symptom expression rapidly [11] Company Strategy and Development Direction - The company aims to become a leading global biopharma, focusing on commercial business growth and advancing its global pipeline [5][6] - The strategy includes leveraging AI to optimize clinical trials and enhance commercial analytics [8] - Business development remains a priority, focusing on strengthening the global pipeline and expanding the China portfolio [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the full-year revenue guidance of $560 million to $590 million, with expectations for accelerating growth in the second half of the year [6][34] - The company is on track to achieve profitability on an adjusted basis by the fourth quarter, supported by disciplined spending and strategic investments [15][33] Other Important Information - The company is preparing for submissions for several late-stage assets, including Bimetuzumab for gastric cancer and tumor treating fields for pancreatic cancer [6][16] - The cash position at the end of the quarter was $832.3 million, indicating a strong financial position [34] Q&A Session Summary Question: Can you help us understand the potential opportunity for bema in frontline gastric cancer? - Management highlighted a significant patient population in China, estimating over 450,000 gastric cancer patients, with about a third overexpressing FGFR2b, indicating a billion-dollar sales potential [36][39] Question: Can you discuss your confidence levels in achieving your 2025 revenue guidance and profitability goal by year-end? - Management reaffirmed confidence in the revenue guidance and profitability goals, expecting accelerating growth driven by VIBGART and other products [44][46] Question: What is the strategy in China between subcutaneous and IV formulation for VIBGART? - Management expects a shift from almost exclusively IV use to significant subcutaneous use as the product gains traction in the market [80] Question: Are you still actively looking for a partner for clinical development of DLL3? - The company plans to initiate the pivotal trial independently but remains open to partnerships [83] Question: What steps are left to file in China for bema? - The focus is on expediting the submission process and aligning with regulatory feedback for a timely approval [87][89]