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Syndax Pharmaceuticals (SNDX) 2025 Conference Transcript
2025-06-05 18:27
Syndax Pharmaceuticals (SNDX) 2025 Conference June 05, 2025 01:25 PM ET Speaker0 Good afternoon, everyone. Thank you for attending Jefferies Global Healthcare Conference. My name is Baozhi, a senior biotech analyst biotech team here. And please join me and welcome CEO, Mr. Michael Metzger CMO, Mr. Nick Batwood and COO, Mr. Steve Closter from Syndax Pharmaceuticals for this fireside chat session. Welcome. Speaker1 Thank you, Kelly. Speaker0 Maybe let's start with a high level question. Last year 2024 was a v ...
Syndax(SNDX) - 2024 Q4 - Earnings Call Transcript
2025-03-03 16:46
Financial Data and Key Metrics Changes - For Q4 2024, Syndax Pharmaceuticals reported $7.7 million in net revenue from Revuforj, marking the company's first quarter with product revenue [10][46] - Operating expenses for Q4 were $104 million, which included $65.5 million in research and development expenses and $37.7 million in selling, general, and administrative expenses [46] - The company maintained a strong financial position with $692.4 million in cash, equivalents, and investments at year-end [47] Business Line Data and Key Metrics Changes - Revuforj, the first-in-class menin inhibitor, launched in November 2024, has shown strong early demand with $7.7 million in net revenue from the first five weeks of sales [10][11] - Niktimvo, launched in January 2025 for chronic graft versus host disease, is expected to capture a significant portion of the $1.5 billion to $2 billion market for third-line or later chronic GVHD treatment in the US [32] Market Data and Key Metrics Changes - Approximately 33% of Tier 1 and Tier 2 accounts have ordered Revuforj, indicating strong early penetration in key treatment centers [21][22] - The company is seeing rapid inclusion of Revuforj in payer coverage, with 56% of commercially covered lives and 53% of all managed care lives having formal coverage policies in place [25] Company Strategy and Development Direction - The company aims to expand Revuforj's indication to include mutant NPM1 AML by filing a supplemental new drug application in the upcoming quarter [12] - Syndax is focused on building a robust pipeline in oncology, with plans to extend its products into earlier line indications and develop additional targeted therapies [99][100] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position for long-term growth, highlighting the strong market opportunities with Revuforj and Niktimvo [54] - The management team emphasized the importance of building a habit among physicians for prescribing Revuforj, which is expected to become the standard of care for KMT2A translocations [24][60] Other Important Information - The company received $350 million upfront from Royalty Pharma in exchange for a capped royalty on US net sales of Niktimvo, indicating the product's multi-billion-dollar potential [15] - The company expects R&D expenses for Q1 2025 to be between $65 million and $70 million, with total R&D plus SG&A expenses projected to be between $105 million and $110 million [48] Q&A Session Summary Question: Inventory levels and repeat prescribers for Revuforj - Management indicated that inventory levels are expected to remain stable at about two to three weeks, with revenue growth potentially increasing absolute inventory levels [62] - Approximately one-third of Tier 1 and Tier 2 accounts have ordered Revuforj, with most accounts having prescribed it more than once, indicating positive early adoption [65] Question: Activation of Tier 1/2 accounts and comparison to historic AML launches - Management expects continued activation of Tier 1 and Tier 2 accounts over the next 10 months, with a focus on the top 200 treatment centers [73] - The unique setup of Revuforj, including diagnostic testing for KMT2A patients, is expected to drive its adoption compared to other targeted therapies [78] Question: Off-label use and Expanded Access Program (EAP) - Anecdotal evidence suggests some off-label use of Revuforj, particularly in combination treatments, but specific numbers are not yet available [86] - The EAP remains lightly used, with no additional patients expected to transition from it at this time [87] Question: Future company vision and pipeline expansion - The company aims to build a larger pipeline in oncology and expects to have multiple commercial products by 2030, focusing on targeted therapies [100][101] Question: Safety feedback and physician experience with Revuforj - Feedback on Revuforj's safety profile has been positive, with comprehensive support provided to physicians through clinical nurse educators [110] Question: Gross to net adjustments and patient assistance programs - The gross to net adjustments for Revuforj are expected to remain tight due to the limited distribution channel, with a patient assistance program available for uninsured or underinsured patients [118][120] Question: Transplant dynamics and patient treatment pathways - Physicians are interested in getting patients to transplant, particularly for KMT2A, with expectations that many patients will return to maintenance therapy post-transplant [122]