Syndax Pharmaceuticals (SNDX) 2025 Conference Transcript

Financial Data and Key Metrics Changes - The company achieved $20 million in sales for the first quarter, surpassing expectations [8][9] - The sales for Niktinvo marked $13.6 million, indicating strong demand and a good start for the product [61] Business Line Data and Key Metrics Changes - RAV4's launch has seen a broad and growing user base, with approximately 44% of tier one and tier two institutions having written prescriptions by March, expected to exceed 50% [10][12] - Formulary coverage has improved significantly, rising from just above 70% in March to over 90% [12] Market Data and Key Metrics Changes - The company is positioned well in the U.S. market with robust supply chains and minimal impact from external factors such as tariffs [6][7] - The KMT2A population is the primary focus, with expectations to achieve over 50% market penetration in the first year [14] Company Strategy and Development Direction - The company aims to expand beyond relapsed-refractory markets and build long-lasting franchises with its first and best-in-class medicines [5] - There is a strong focus on moving into frontline combinations and addressing both fit and unfit patient populations through randomized control studies [51][52] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's positioning amidst evolving policies on drug pricing and tariffs, stating that the supply chains are robust [6][7] - The company anticipates significant growth opportunities in the coming year, particularly with the expected approval of the sNDA for the NPM1 patient population [70][71] Other Important Information - The company is actively enrolling patients in the EVOLVE study, which is a large multi-site international study with dual primary endpoints [55] - The company expects to present updated data at the EHA Congress, which will include Kaplan Meier's around overall survival [59] Q&A Session Summary Question: What are the dynamics of the RAV4 launch? - The launch has exceeded expectations with a broad user base and improved formulary coverage, leading to strong sales momentum [9][12] Question: How is the company managing safety concerns with Revuforge? - Physicians are well-equipped to manage side effects, and early experiences have been positive with no significant hindrances to patient treatment [24][29] Question: What is the timeline for the NPM1 supplementary NDA review? - The supplementary NDA was submitted in April, with a six-month priority review expected to conclude around October [32] Question: How does the company plan to position Revuforge against competitors? - The company believes it has a compelling profile and is the only approved menin inhibitor, with strong efficacy data supporting its use [41][42] Question: What milestones should investors look for in the next twelve months? - Key milestones include data presentations at EHA, expected approval of the sNDA, and continued growth in KMT2A and NPM1 franchises [70][71]