Financial Data and Key Metrics Changes - Total revenue grew 49% year over year to a record of almost $72 million in Q2 2025, driven by strong demand across the product portfolio [5][14] - Net product revenue increased 46% to approximately $67.7 million, with RECORLEV leading the growth [14][15] - Adjusted EBITDA was positive at $12.5 million, reflecting an improvement of nearly $13 million year over year [19] Performance by Product Line - RECORLEV revenue reached over $31 million, a 136% increase year over year, with a 122% increase in the average number of patients on therapy [7][14] - Gvoke generated $23.5 million in revenue, a 17% increase compared to the previous year, supported by a 5% growth in total prescriptions [15][10] - KEVEYIS revenue was over $11.5 million, showing a modest increase in the average number of patients on therapy [10][15] Market Data and Key Metrics Changes - The company anticipates total revenue for 2025 to be in the range of $280 million to $290 million, representing a year-over-year growth of 40% at the midpoint [6][20] - The hypercortisolism market is expanding, with increased attention on cortisol testing, which is expected to benefit all players in the market [29] Company Strategy and Development Direction - The company is focused on strategic investments to drive sustained growth, particularly in RECORLEV and the pipeline asset XP-8121 [12][21] - The company plans to expand its commercial footprint and increase investments to support the dynamic growth in the hypercortisolism market [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong performance and growth opportunities ahead, citing the positive trajectory of commercial products [6][13] - The company remains committed to delivering continued positive adjusted EBITDA while making deliberate value-driven investments [22] Other Important Information - The company celebrated the ten-year anniversary of KEVEYIS' FDA approval, highlighting its importance in treating patients with primary periodic paralysis [10] - The company is leveraging proprietary technology to develop a novel formulation for XP-8121, targeting a significant unmet medical need in hypothyroidism [12] Q&A Session Summary Question: Can you talk about the gross to net benefit for Gvoke? - Management anticipates that the favorability will continue for the balance of the year [23] Question: How do you see the script growth for Gvoke in the back half of the year? - Management expects an increase in script growth in Q3, typically a stronger quarter due to back-to-school movements [26] Question: Where are RECORLEV prescriptions coming from? - The majority of prescriptions are from endocrinologists, with over half of patients being new to therapy [27] Question: How will the competitive environment change with a new drug launch? - Management believes that more players in the market will generate more awareness and growth opportunities for all [29] Question: What are the plans for long-term spending to support RECORLEV? - The company plans to increase its commercial footprint and make significant investments in the RECORLEV brand [34] Question: Will there be further clinical data generated for RECORLEV? - Management confirmed plans to generate more data to solidify RECORLEV's value proposition [37] Question: How do you see the treatment landscape for Gvoke evolving? - There is significant opportunity to reach patients who currently do not have access to rescue glucagon, with a large number of patients still unprotected [41]

Amphastar Pharmaceuticals Conference Call Summary Company Overview - Amphastar Pharmaceuticals is a biopharmaceutical company focused on injectable and inhalation products, emphasizing complex generic injectables and proprietary products [4][5] - Key products include Primatene Mist, the only OTC FDA-approved asthma medication, and Baqsimi, a nasal glucagon product acquired from Eli Lilly [5] Financial Performance - The company anticipates flat revenues for the year, with slight declines in earnings due to increased competition affecting gross margins on key products [7] - A significant increase in R&D budget is noted as the company explores more complex generic products and proprietary offerings [7] - The goal is to return to double-digit sales growth in the following year [8] Product Insights Baqsimi - Baqsimi is a major growth driver, with growth attributed to increased awareness and feasibility among insulin-prescribing patients [9] - Currently, only about 12% of insulin patients have glucagon on hand, indicating significant room for growth [10][11] - The product's ease of use compared to traditional glucagon kits is highlighted as a competitive advantage [15][19] - Baqsimi is expected to see high single-digit growth for the year, with a price increase of 3% in the U.S. contributing to overall sales growth [22][28] Primatene Mist - Primatene Mist is projected to grow by high single digits this year, supported by national media coverage and expanded marketing efforts targeting primary care physicians [30][31] - The company is piloting a small sales force to enhance brand growth, with plans to evaluate its success in 2026 [32][35] Competitive Landscape - Baqsimi is the leading prescribed glucagon in the U.S., outperforming competitors like Gvoke due to its intranasal delivery method, which is preferred by caregivers [18][20] - The company is optimistic about maintaining its market position and continuing to grow its share [16][19] Pipeline and Future Growth - Amphastar has four ANDAs under FDA review, with expectations to receive approvals for two products by year-end [39] - The pipeline includes complex generics and an inhalation product, which is seen as promising due to the lack of existing generics in the market [53][56] - The company anticipates peak sales for Baqsimi in the range of $250 million to $275 million over the next several years [26] Manufacturing and Tariff Exposure - All finished products are manufactured in the U.S., with some active ingredients sourced from China and France [63] - The company estimates a quarterly impact of approximately $500,000 due to tariffs on certain APIs, but this is not considered material [64] R&D Strategy - Amphastar's strategy focuses on internal R&D, leveraging the expertise of its scientific founders [69] - The company is open to future acquisitions that align with its manufacturing capabilities and product focus, particularly in the endocrinology space [70]

Xeris Biopharma Holdings (XERS) 2025 Conference June 04, 2025 01:25 PM ET Speaker0 Health care conference day one. My name is Dennis Ding. I'm the biotech analyst here at Jefferies. I have the pleasure of having Xeris Biopharma here. We have CEO John Shannon as well as CFO Steve Piper here. Welcome. Speaker1 Thank you. Welcome. Speaker2 Yes, thanks for having us. Speaker0 So maybe to kick things off, just level set us in terms of where you are as a company and maybe talk also about the progress you have mad ...

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 ...

Xeris Biopharma Holdings (XERS) Q1 2025 Earnings Call May 08, 2025 08:30 AM ET Company Participants Allison Wey - Senior Vice President of Investor Relations & Corporate CommunicationsJohn Shannon - CEOSteve Pieper - Chief Financial OfficerMazahir Alimohamed - Biotech Equity Research AssociateJason Dorr - Associate Director Conference Call Participants David Amsellem - Sr. Research AnalystChase Knickerbocker - Senior Equity Research Analyst - Healthcare Operator Good morning. Thank you for attending today's ...

Xeris Biopharma Holdings (XERS) Q1 2025 Earnings Call May 08, 2025 08:30 AM ET Speaker0 Good morning. Thank you for attending today's Verisk Biopharma First Quarter twenty twenty five Results Conference Call. My name is Makayah, and I'll be the moderator for today's call. All lines will be muted during the presentation portion of the call with an opportunity for your questions and answers at the end. At this time, I would like to pass the call over to our Senior Vice President of Investor Relations and Corp ...

Financial Data and Key Metrics Changes - Total revenue for 2024 was over $203 million, growing 24% year-over-year, driven by strong demand for Recorlev and Gvoke [8][14] - Net product revenue for Q4 2024 was $57 million, marking a 34% increase compared to the prior year [28] - Adjusted EBITDA turned positive in Q4 2024, with expectations to remain positive going forward [15][43] Business Line Data and Key Metrics Changes - Recorlev achieved $64.3 million in revenue for 2024, a 118% increase compared to 2023, with Q4 revenue of $22.6 million, up 131% year-over-year [9][28] - Gvoke generated nearly $83 million in revenue for 2024, a 24% increase, with Q4 revenue of $23.3 million, also a 25% increase [10][30] - Keveyis ended 2024 with approximately $50 million in revenue, a 13% decline year-over-year, but maintained a steady patient base [11][36] Market Data and Key Metrics Changes - The market for hypercortisolemia is expanding, with increasing diagnoses leading to more patients being treated [16][17] - Gvoke targets a large untapped market, with an estimated 14 million patients unprotected by life-saving therapies [18][19] Company Strategy and Development Direction - The company aims for total revenue between $255 million and $275 million in 2025, representing over 30% year-over-year growth at the midpoint [14][36] - Strategic priorities include driving growth of commercial products, maintaining financial discipline, and enhancing communication with stakeholders [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth, particularly for Recorlev and Gvoke, while anticipating steady demand for Keveyis [36][38] - The company is focused on leveraging its existing commercial capabilities for the development of XP-8121, a new product for hypothyroidism [25][102] Other Important Information - The company reported a gross margin of 84% in Q4 2024, a 1% improvement year-over-year, driven by a favorable product mix [32] - The company ended 2024 with a healthy cash position of $71.6 million [35] Q&A Session Summary Question: Recorlev strength and prescriber growth - Management noted both expansion of the writer base and increased prescriptions from existing prescribers contributing to Recorlev's growth [47] Question: Year-over-year prescription growth in hypercortisolism - Management indicated a lack of specific data on market growth but emphasized the importance of field efforts to identify patients [49] Question: Expectations for Keveyis in 2025 - Management suggested Keveyis may have found its bottom, with expectations to hold steady despite potential pressures on reimbursement [54] Question: Long-term spend to support Recorlev - Management acknowledged the need for continued investment in Recorlev, with a focus on expanding awareness and treatment [81][88] Question: Durability and exclusivity runway for Recorlev - Patents for Recorlev extend to 2040, with orphan exclusivity through 2028, providing a significant runway for growth [84][86] Question: Gvoke and updated guidelines - Management is focused on raising awareness of new guidelines to protect unprotected patients, viewing it as a long-term opportunity [94] Question: Phase 3 readiness for XP-8121 - Management confirmed plans for Phase 3 readiness, with potential clinical trials starting in 2026 [95]