Financial Data and Key Metrics Changes - The company recognized $1 million in revenue from licensing and supply agreements with its Japanese partner SKK for the second quarter [33] - Research and development expenses increased to $80.3 million in Q2 from $76.2 million in Q1, reflecting continued investment in clinical programs [33] - Selling, general and administrative expenses rose to $49.8 million in Q2 from $35.5 million in Q1, primarily due to investments in commercial capabilities [33] - The company ended the quarter with $1.2 billion in cash, cash equivalents, and investments [34] - The high end of the guidance for net cash used in operations in 2025 was lowered to $370 million from $380 million, reflecting greater precision on clinical timelines [35] Business Line Data and Key Metrics Changes - The company is preparing for the launch of Palsonify, its treatment for acromegaly, with a strong focus on building a commercial team and engaging with healthcare professionals [13][16] - Market research indicates that healthcare professionals view Palsonify as the preferred therapy among newly diagnosed patients due to its rapid reduction of IGF-1 levels [17] - There are approximately 500 newly diagnosed patients per year who are candidates for pharmaceutical therapy, and 11,000 currently diagnosed patients with high unmet needs [17] Market Data and Key Metrics Changes - The company is actively engaging with the patient community and healthcare professionals to shape its commercial strategy for Palsonify [8][20] - There is a significant opportunity to activate patients who have discontinued therapy or are dissatisfied with current treatment options, as nearly 80% of patients on injectable SRLs did not persist with treatment [19] - The company believes there are at least 17,000 undiagnosed patients who could benefit from treatment [20] Company Strategy and Development Direction - The company aims to transform the lives of patients with acromegaly through the anticipated launch of Palsonify and is focused on expanding the market by bringing in previously untreated patients [20] - The company is also advancing multiple pivotal programs, including trials for carcinoid syndrome and congenital adrenal hyperplasia [10][27] - The commercial strategy includes a disease state education campaign and patient support hub to increase awareness and empower patients [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the NDA review process for paltusotine, anticipating approval in September [6][25] - The company is optimistic about the potential of Palsonify to become the preferred treatment for the acromegaly community, supported by positive feedback from healthcare professionals [22] - Management acknowledged that patient engagement and education will be crucial for driving adoption post-launch [20][105] Other Important Information - The company is preparing for a potential launch in Europe in 2026 and is actively working with payers to ensure access pathways for Palsonify [23][22] - The company has made significant progress in its clinical pipeline, including ongoing studies for adamelin in congenital adrenal hyperplasia [29][30] Q&A Session Summary Question: How does the launch of Neurocrine's product affect enrollment for Phase III studies? - Management believes the launch raises awareness of the unmet need and positively impacts enrollment, particularly as most enrollment occurs outside the U.S. [40][42] Question: What is the timeline for IND submissions for TSH and SST3 agonists? - The company is targeting the end of the year for IND submissions for both molecules [46][47] Question: What is the comfort level with current consensus numbers for the paltusotine launch? - Management refrained from commenting on consensus numbers but expressed confidence in launch preparations [50][52] Question: What are the expectations around placebo response in the global CAH Phase III study? - Management does not expect a high placebo response rate and believes the trial is well-powered [55][56] Question: Will pricing for Palsonify be discussed at the time of approval? - Management indicated that pricing discussions will occur at the appropriate time post-approval, emphasizing the positive reception of the value proposition by payers [59][62] Question: How many patients are currently in the open-label extension for Palsonify? - Management noted that the open-label extension is ongoing in multiple countries, and decisions regarding patient transitions to commercial treatment will depend on regulatory outcomes [69][74] Question: What are the potential endpoints for Cushing's disease trials? - The primary endpoint will be normalization of 24-hour urine free cortisol excretion, with rapid normalization observed in initial trials [99][100] Question: How does the company plan to manage the progression towards NDA submission for atomelanit? - The company plans to treat each study as a distinct submission and will not hold one until the other is completed [121][123] Question: Is there a market for surgically naive patients for paltusotine? - While there is an unmet need, the company is not actively considering that segment at this time [127]

Xeris Biopharma Holdings (XERS) 2025 Investor Day June 03, 2025 10:00 AM ET Speaker0 Could everyone woah. Take their seats, please. Because we do have people on a live webcast so we want to start on time for them. Okay, two minutes. So everyone, this is your chance to turn your phones off for the ringers. Thank you. I can do it with a whistle, but that's really loud with a mic. Thank you everybody for coming to our very first Analyst and Investor Day. I appreciate you taking the time out of your day and the ...

Investment Rating - The investment rating for the company is a specialized IPO score of "5.3" [7][9]. Core Insights - The company, Weisheng Pharmaceutical-B (2561.HK), is a late-stage biopharmaceutical firm focused on providing treatment solutions for specific endocrine diseases in China, including Hong Kong, Macau, and Taiwan. It has one core product and two other candidate drugs in development, all licensed from its partner and major shareholder, Ascendis Pharma [1]. - The Chinese growth hormone market is experiencing significant growth, with a market size increasing from 4 billion yuan in 2018 to 11.6 billion yuan in 2023, representing a compound annual growth rate (CAGR) of 23.9%. It is expected to reach 28.6 billion yuan by 2030, with a projected CAGR of 13.7% from 2023 to 2030 [3]. - The company has a highly certain pipeline nearing commercialization, with its core product, Longpei Growth Hormone, being a long-acting growth hormone replacement therapy for PGHD, which has already received acceptance for BLA submission by the National Medical Products Administration [4]. Financial Status - As of now, the company has no commercialized products and has not achieved profitability. The other income for the years 2022, 2023, and up to September 30, 2024, was 5.764 million yuan, 11.356 million yuan, and 8.647 million yuan, respectively, with total losses of 290 million yuan, 250 million yuan, and 130 million yuan for the same periods [2]. Industry Status and Outlook - The growth in the demand for growth hormone treatments, the continuous emergence of treatment solutions, and the increasing awareness of growth hormone deficiency among patients are the main drivers for future industry growth [3]. Competitive Advantages - The company possesses a pipeline based on proven technologies, with a high degree of certainty in approaching revenue generation. The management team is highly capable of commercialization and has strong support from shareholders and investors [4]. Use of Proceeds from IPO - Approximately 84.0% of the proceeds will be used for the ongoing BLA registration of the core product and the planned commercialization of Longpei Growth Hormone. About 7.6% will fund the ongoing Phase 3 pivotal trial of Parolepitide in China, while 1.8% will support the ongoing Phase 2 trial of Navepitide for treating achondroplasia. The remaining 6.6% will be allocated for working capital and general corporate purposes [5].