Syndax Pharmaceuticals, Inc. (SNDX) Q3 2025 Earnings Call Transcript

Access earnings results, analyst expectations, report, slides, earnings call, and transcript.

Overview

The earnings call summary highlights strong financial performance, product development, and market strategy, with optimistic guidance and shareholder return plans. The Q&A section provides additional positive insights, such as excellent payer access and a consistent safety profile for Revuforj. The strategic plan indicates significant growth opportunities, including market expansion and profitability outlook. Considering the company's strong market position, upcoming product approvals, and positive financial health, the stock is likely to see a positive movement in the short term.

Key Financial Performance

Total Revenue $45.9 million for the third quarter, representing strong 21% growth over the prior quarter. The growth is attributed to the launch metrics for Revuforj and Niktimvo, which are addressing major unmet patient needs.

Net Revenue for Revuforj $32 million in the third quarter, up 12% from the prior quarter. Growth occurred despite approximately 1/3 of patients temporarily pausing treatment to receive a stem cell transplant. Indicators of demand remain strong with approximately 25% growth in total prescriptions and new patient starts.

Net Revenue for Niktimvo $45.8 million in the third quarter, a robust 27% increase over the prior quarter. The growth is attributed to rapid and durable improvements observed in patients and increasing adoption among healthcare providers.

Collaboration Revenue from Niktimvo $13.9 million for the third quarter. Niktimvo continues to be a positive cash flow contributor to Syndax, with a margin contribution expected to grow as sales increase.

Cash Position $456 million in cash, equivalents, and short- and long-term investments as of September 30, 2025. The company expects to reach profitability with current funds on hand.

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Operating Highlights

Revuforj: Generated $32 million in net revenue in Q3 2025, up 12% from the prior quarter. It has become the standard of care for relapsed/refractory KMT2A and is being used earlier in treatment paradigms. FDA approval for relapsed/refractory NPM1 mutated AML was received, tripling the addressable patient population. Physicians are enthusiastic about its efficacy, with unmatched data including a 50% overall response rate and 2-year median overall survival among responders.

Niktimvo: Generated $45.8 million in net revenue in Q3 2025, a 27% increase from the prior quarter. It is annualizing at nearly $200 million and is profitable to Syndax. Physicians report rapid and durable improvements in chronic GVHD patients, with 80% of patients remaining on therapy since Q1 2025.

Market Expansion for Revuforj: FDA approval for relapsed/refractory NPM1 mutated AML expanded the addressable U.S. population from 2,000 to 6,500 patients annually, representing a $2 billion market opportunity. Expansion into the frontline setting is underway, targeting a combined market opportunity exceeding $10 billion.

Market Expansion for Niktimvo: Niktimvo is addressing a $2 billion market opportunity in chronic GVHD, with significant room for growth as it gains adoption in earlier lines of therapy.

Revenue Growth: Total revenue for Q3 2025 was $45.9 million, a 21% increase over the prior quarter. Revuforj and Niktimvo are driving growth, with Revuforj showing 25% growth in prescriptions and new patient starts.

Operational Efficiency: Syndax maintains a strong financial position with $456 million in cash and investments. Operating expenses are stable, and the company is on track to achieve profitability with current funds.

Strategic Priorities: Focus on expanding Revuforj and Niktimvo into the frontline setting, which could unlock a combined market opportunity exceeding $10 billion. The company is also advancing pivotal trials for both products to solidify leadership in their respective markets.

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Risk or Challenges

Regulatory and Reimbursement Challenges: The company faces potential challenges in maintaining favorable gross-to-net adjustments due to higher proportions of 340B business and increased exposure to Medicare and Medicaid, which mandate statutory discounts. This could impact revenue growth.

Supply Chain and Inventory Management: There was a slight drawdown of inventory in the channel, which could indicate potential risks in maintaining consistent supply levels.

Market Competition: While the company has a first-mover advantage in menin inhibitors, competition from other companies entering the market could erode market share over time.

Strategic Execution Risks: The company’s ability to expand into the frontline setting and execute pivotal trials like EVOLVE-2 and REVEAL is critical. Any delays or failures in these trials could significantly impact growth projections.

Economic and Financial Risks: The company’s profitability is contingent on maintaining stable operating expenses and achieving projected revenue growth. Any unexpected increases in costs or slower-than-expected revenue growth could delay profitability.

Post-Transplant Maintenance Adoption: The adoption of Revuforj in the post-transplant maintenance setting is still building. If adoption rates do not meet expectations, it could impact long-term revenue growth.

Physician and Patient Adoption: The success of new indications like NPM1 depends on rapid physician and patient adoption. Any delays in awareness or trust-building could slow market penetration.

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Guidance & Outlook

Revenue Growth: Sales growth is expected to accelerate in the coming quarters due to the approval of Revuforj for NPM1 and increasing average duration of therapy in KMT2A patients.

Market Opportunity: The expansion of Revuforj into NPM1 increases the annual total addressable U.S. population from 2,000 to 6,500 incident patients, representing a $2 billion-plus market opportunity.

Frontline Expansion: Strategic priorities include expanding Revuforj and Niktimvo into the frontline setting, unlocking a combined market opportunity exceeding $10 billion.

Clinical Trials: Enrollment is underway for the pivotal EVOLVE-2 trial for Revuforj in the frontline setting, and two frontline trials for Niktimvo are ongoing in combination with standard of care therapies.

Profitability: Syndax expects to reach profitability with current funds on hand, supported by increasing cash flow contributions from Revuforj and Niktimvo and a stable expense base.

Product Differentiation: Revuforj is positioned as the first and only menin inhibitor FDA-approved for multiple acute leukemia subtypes, with unmatched efficacy data in relapsed/refractory NPM1 and KMT2A patients.

Long-Term Therapy: The average duration of therapy for KMT2A patients is expected to increase to 6-12 months in 2026 as treatment patterns mature.

Niktimvo Growth: Niktimvo is expected to continue robust growth, with patients likely to remain on therapy for years due to the chronic nature of GVHD and high response rates.

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Shareholder Return Plan

The selected topic was not discussed during the call.

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Key Q&A

Q:Can you review how Revuforj's place in lines of therapy has evolved in the commercial setting during the launch? And how do you think this will translate for the NPM1 setting? Would physicians with experience with Revuforj be more willing to use it in earlier lines of therapy?

A:Michael Metzger explained that for KMT2A, about 70% of the business is in second or third line, which is a shift from clinical trials where third and fourth line were the average. This earlier treatment has led to better outcomes, longer treatment durations, and an increase in patients going to transplant (from 25% in trials to about 1/3 in commercial use). For NPM1, similar trends are expected, with high response rates and earlier treatment utilization, including combination therapies.

Q:You spoke about a 6- to 12-month range for duration of therapy in 2026. Could you help us think about the key factors that you're looking to understand in order to narrow that range? And when could that start to be reflected in the revenue trajectory?

A:Michael Metzger stated that the 6- to 12-month range in 2026 reflects the mix of KMT2A and NPM1 patients. KMT2A patients tend to have longer durations due to higher transplant rates, while NPM1 patients, being a larger population, have shorter durations due to fewer transplants. The impact of these dynamics will be felt in 2026 as more patients return from transplant and receive maintenance therapy.

Q:Have you looked at all where the maintenance restart rate is for the patients who started revumenib during the first few months of launch?

A:Michael Metzger noted progress in the restart rate, which increased from about 1/3 to 35%-40%. Physicians are keen to restart therapy post-transplant, with some estimating 80%-90% of patients could return, though external factors may influence this.

Q:Could you provide some perspective in terms of how revenue per prescription might evolve as the patient mix shifts from predominantly KMT2A in the third quarter to include more NPM1 patients going forward?

A:Keith Goldan stated that no significant change in average revenue per prescription is expected as more NPM1 patients are included in the prescribing base.

Q:Is there any way to break down the gap between quarter-over-quarter growth results versus the Rx rate? And is there any friction with NPM1 authorizations and payer access?

A:Keith Goldan explained that the gap between net revenue and prescription growth was due to higher gross-to-net adjustments and a slight drawdown in inventory. Steven Closter added that payer access for Revuforj has been excellent, with 97% formulary coverage by month 5 and no significant pushback from payers, even for off-label prescriptions.

Q:Did you notice any modest uptick in the final days of Q3 where you did have that inclusion in NCCN Guidelines? And how should we think about the launch trajectory in the NPM1 population in terms of market penetration relative to the launch in the KMT2A market?

A:Michael Metzger noted that the NCCN Guidelines inclusion in late September did not significantly impact Q3 but sets up well for Q4. Steven Closter highlighted that awareness and excitement are high, with strong relationships and execution expected to drive market penetration. The NPM1 population is larger but may face competition.

Q:How are you philosophically thinking about specifically evaluating the contribution of maintenance therapy within the REVEAL trial protocol?

A:Nicholas Botwood explained that maintenance therapy is considered within pivotal studies, allowing for maintenance after transplant. A broad body of evidence from various studies will support its use in the frontline setting.

Q:Are you seeing any differences between community practices and academic centers in terms of the percent going to transplant and the percent returning to maintenance post-transplant?

A:Steven Closter stated that the majority of usage is in academic centers, with no detailed data yet available to differentiate treatment and maintenance rates between community and academic settings.

Q:Could NPM1 patients who had transplants but did not receive Revuforj before still get it as maintenance therapy?

A:Nicholas Botwood confirmed that some centers are starting NPM1 patients on Revuforj as maintenance therapy post-transplant, even if they did not receive it prior to transplant.

Q:How is the safety profile of Revuforj faring in the real world? Are patients discontinuing the drug due to adverse events?

A:Nicholas Botwood reported a consistent safety profile with low rates of serious cardiac complications and discontinuations. Physicians are experienced in managing the drug, and adverse events are well managed.

Q:As you think about first-line treatment where there are more patients, is it reasonable to expect more cases of Torsades, and how will you manage this?

A:Nicholas Botwood stated that rates of serious cardiac events are lower in the frontline setting, possibly due to fitter patients. Randomized trials will provide more data, but current rates are very low, and physicians are not changing their practices based on the label.

Q:Could you provide additional detail around the timing of maintenance use post-transplant?

A:Michael Metzger explained that patients typically receive 2-3 months of therapy before transplant, are off Revuforj for a period, and resume maintenance therapy about 3-4 months later, totaling around 6 months from start to resumption.

Q:When would the revenue split between KMT2A and NPM1 become more balanced or NPM1 dominant?

A:Michael Metzger noted that NPM1 is a larger population, but KMT2A has longer treatment durations due to higher transplant rates. It is difficult to predict the exact timing, but the company expects to dominate both segments.

Q:How are you thinking about competitive positioning and regulatory strategy for frontline combination regimens based on recent data?

A:Nicholas Botwood highlighted the strong efficacy profile of Revuforj in combination regimens, with compelling data in both oral and intensive chemotherapy settings. The company is well positioned with ongoing frontline programs and does not see differentiating data from competitors.

Q:What is the impact of the NPM1 approval on gross-to-net and inventory trends? How challenging is it to restart a patient on Revuforj post-transplant from an administrative or payer perspective?

A:Keith Goldan stated that inventory levels will remain at 2-3 weeks, and gross-to-net adjustments will stay within the 20%-25% range. Steven Closter added that there is no significant payer pushback for restarting patients on maintenance therapy post-transplant.

Q:Review of Unclear Management Responses

A:Management avoided providing a direct answer to the question about differences in transplant and maintenance rates between community and academic centers, citing a lack of detailed data to differentiate the two settings.

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Earnings Word Cloud

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