Syndax Pharmaceuticals (NasdaqGS:SNDX) Q4 2025 Earnings call February 26, 2026 04:30 PM ET Company ParticipantsClara Dong - VP of Equity Research in BiotechnologyCorinne Johnson - Managing DirectorDavid Dai - DirectorJason Zemansky - VP of Equity ResearchJosh Bowen - DirectorKeith Goldan - CFOMichael Metzger - CEONick Botwood - Head of R&D and Chief Medical OfficerPriyanka Grover - VP of Biotechnology Equity ResearchSharon Klahre - Head of Investor RelationsStephen Willey - Managing DirectorSteve Closter - ...

Fourth Quarter and Full Year 2025 Financial Results February 26, 2026 Forward-looking statements disclosure This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events, progress, timing or circumstances) are intended to identify forward-looking statements. All statements other than statements ...

Summary of Syndax Pharmaceuticals Conference Call Company Overview - **Company**: Syndax Pharmaceuticals (NasdaqGS:SNDX) - **Date**: February 12, 2026 - **Key Speakers**: Michael Metzger (CEO), Nick Botwood (CMO, Head of R&D), Keith Goldan (CFO) Core Points and Arguments Financial Performance - **Revuforj**: Achieved $125 million in annual net sales, with a quarter-over-quarter growth of 38% in Q4 2025, indicating strong market performance and expansion in its labeled indications [2][4] - **Niktimvo**: Generated $152 million in sales within the first 11 months of launch for chronic GVHD, also showing significant quarter-over-quarter growth [2] Product Development and Market Strategy - **Revuforj**: - Focused on KMT2A and NPM1 indications, with new NCCN guidelines and approvals driving growth [4][5] - Anticipated to capture a dominant market share in NPM1, similar to its established position in KMT2A [9] - Current maintenance therapy uptake for KMT2A is 35%-40%, with expectations to grow to 70%-80% over time [10][13] - **Niktimvo**: - Currently approved for later-line chronic GVHD, with a potential market of approximately 6,500 patients in the U.S. for third-line treatment, and an estimated peak opportunity approaching $1 billion [23][24] - Collaboration with Incyte involves a 50/50 profit split, with expectations for long-term growth in revenue share [24][26] Research and Development - **IPF Phase II Trial**: - Expected to read out in the second half of 2026, with a well-designed study focusing on forced vital capacity as the primary endpoint [30][34] - Strong preclinical data supports the role of CSF1R inhibition in IPF, with significant improvements noted in related conditions [32][40] - **Future Opportunities**: - Plans to explore the role of revumenib in myeloproliferative neoplasms (MPN), with promising preclinical results [20][21][22] Path to Profitability - Syndax aims for profitability potentially by 2027, supported by strong revenue from both Revuforj and Niktimvo, while maintaining flat operating expenses at $400 million [46] Additional Important Insights - The company is fully funded and does not require additional cash, positioning it well for future growth [46] - The collaboration with Incyte extends to future trials, including potential IPF studies, with shared costs and responsibilities [45] This summary encapsulates the key points discussed during the conference call, highlighting the financial performance, product development strategies, research initiatives, and the company's path to profitability.

Financial Data and Key Metrics Changes - Syndax reported total revenue of $45.9 million for Q3 2025, reflecting a strong 21% growth over the prior quarter [4] - Revyforge net revenue was $32 million in Q3, up 12% from the prior quarter, with a 25% increase in total prescriptions and new patient starts [5][11] - Nictimvo net revenue reached $45.8 million in Q3, marking a 27% increase over the prior quarter [9][19] Business Line Data and Key Metrics Changes - Revyforge has become the standard of care for relapsed refractory KMT2A, with approximately 50% of usage in the second line [5] - Nictimvo is annualizing at nearly $200 million within the first eight months of launch, tracking in line with first-year sales of similar therapies [9] - The approval of Revyforge for relapsed refractory NPM1 mutated AML has expanded the addressable patient population significantly [6][15] Market Data and Key Metrics Changes - The total addressable U.S. population for Revyforge has increased from approximately 2,000 to 6,500 patients with the new indication [15] - Nictimvo is targeting a market opportunity of approximately $2 billion, with 6,500 patients in the U.S. requiring three or more lines of therapy [21] Company Strategy and Development Direction - The company aims to expand Revyforge and Nictimvo into the frontline setting, unlocking a combined market opportunity exceeding $10 billion [10] - Syndax is focused on executing pivotal trials for menin inhibitors, with Evolve 2 being the first frontline trial to start enrolling patients [10][28] - The company is leveraging its strong commercial foundation and prescriber relationships to drive growth in both product lines [16][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching profitability, citing strong performance from both Revyforge and Nictimvo [38] - The company anticipates that the average duration of therapy for KMT2A patients will increase to six to twelve months in 2026 as treatment patterns mature [14][44] - Management highlighted the positive feedback from healthcare providers regarding the efficacy and tolerability of both Revyforge and Nictimvo [20][22] Other Important Information - Syndax has a strong financial position with $456 million in cash equivalents and investments as of September 30, 2025 [38] - The company has received three FDA approvals and is positioned for sustained growth with its current product offerings [39] Q&A Session Summary Question: How has Revyforge's place in lines of therapy evolved? - Management noted that about 70% of Revyforge's business is in the second or third line, a shift from clinical trials where patients were typically in third or fourth line [41][42] Question: What factors will help narrow the duration of therapy range for 2026? - Management indicated that the mix of KMT2A and NPM1 patients will influence the duration of therapy, with expectations for longer durations as more patients return from transplant [44][45] Question: What is the maintenance restart rate for patients who started Revyforge during the launch? - The restart rate has increased to about 35%-40%, with expectations for further growth as more patients return from transplant [46][47] Question: How will revenue per prescription evolve with the inclusion of more NPM1 patients? - Management does not expect significant changes in average revenue per prescription as NPM1 patients are integrated into the prescribing base [49] Question: What has been the impact of the NCCN guidelines on the NPM1 launch? - Management reported strong awareness and excitement among healthcare providers, setting a positive trajectory for the NPM1 launch [54][56]

Financial Data and Key Metrics Changes - Syndax Pharmaceuticals reported net revenue of $20 million for RevuForge in Q1 2025, marking the first full quarter of its launch [6][35] - Nictimvo achieved net revenue of $13.6 million in the first two months of its launch, with Syndax reporting a collaboration loss of only $200,000 for this period [6][36] - The company maintained a strong financial position with $602.1 million in cash and equivalents as of March 31, 2025 [7][39] Business Line Data and Key Metrics Changes - RevuForge's launch has seen strong adoption, with 44% of tier one and tier two accounts ordering the product as of March, up from one-third in February [16] - Nictimvo has been administered in over 1,250 infusions year-to-date, with approximately 95% of top accounts ordering the product [24] Market Data and Key Metrics Changes - The current indication for RevuForge targets an estimated 2,000 patients in the U.S. with relapsed or refractory acute leukemia with a KMT2A translocation, representing a $750 million market opportunity [20] - The total addressable market for Nictimvo is estimated to be between $1.5 billion to $2 billion, targeting 6,500 chronic GVHD patients in the U.S. [10][26] Company Strategy and Development Direction - Syndax aims to position RevuForge as the first menin inhibitor included in clinical guidelines for treating relapsed or refractory mutant NPM1 AML, with plans for a supplemental new drug application (sNDA) to the FDA [8][11] - The company is focused on executing strategic launch imperatives to ensure long-term competitive immunity ahead of potential me-too products entering the market [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong commercial opportunities for both RevuForge and Nictimvo, highlighting the high unmet medical need and the compelling profiles of their medicines [5][6] - The company anticipates that RevuForge will be the first menin inhibitor approved in the frontline setting, with ongoing trials expected to support accelerated approval [11][12] Other Important Information - The EVOLVE-two trial, a pivotal frontline trial for a menin inhibitor, has been initiated, targeting newly diagnosed patients with high unmet medical needs [7][28] - The company has seen robust engagement with the FDA regarding its sNDA filing and overall programs [9] Q&A Session Summary Question: What are you seeing regarding repeat prescribers for RevuForge? - Management noted that 44% of tier one and tier two accounts have ordered RevuForge, with about 80% of those having ordered more than once, indicating a growing user base [44][46] Question: Can you comment on patients receiving RevuForge and their transplant rates? - Management stated that anecdotal information suggests patients are being taken to transplant, and they expect patients to return to RevuForge post-engraftment [52][53] Question: What are the month-over-month trends for new patient adds for RevuForge? - Management indicated that while they are not providing specific numbers yet, they are happy with the steady stream of new patients and refill rates [57][60] Question: Can you provide insights on trends in GVHD and any subgroup details? - Management mentioned that it is still early to provide detailed information on GVHD subgroups, but they are collecting real-world evidence [67][70] Question: What portion of the $20 million revenue for RevuForge stems from refill dynamics? - Management stated that both new patient starts and refill dynamics are building, but specific numbers are not available yet [92][95]