Syndax Pharmaceuticals Q3 2024 Earnings Call Recap

Syndax Pharmaceuticals (NASDAQ: SNDX) held its earnings call for the third quarter of 2024, emphasizing its financial advancement and clinical progress. CEO Michael Metzger announced a significant $350 million royalty agreement with Royalty Pharma for Niktimvo, which is expected to solidify the company’s financial position and aid in the commercialization of both Niktimvo and revumenib.

The FDA's approval of Niktimvo for chronic graft-versus-host disease and the anticipated approval of revumenib for acute leukemia were also highlighted as key achievements.

Key Takeaways

• Syndax Pharmaceuticals entered a $350 million royalty agreement with Royalty Pharma for Niktimvo.
• FDA approved Niktimvo for cGVHD after multiple systemic therapy failures.
• Revumenib is expected to receive FDA approval by December 26, 2024, for acute leukemia.
• Syndax reported $399.6 million in cash as of September 30, aiming for profitability.
• Operating expenses for Q3 were $102.1 million, with 2024 guidance narrowed to $365 million to $370 million.
• Syndax is preparing for the commercial launch of Niktimvo in early Q1 2025, targeting a $1.5 billion to $2 billion market for third-line cGVHD treatment.
• Revumenib clinical data shows promise, with plans to present at the ASH conference and initiate a pivotal Phase 3 trial.

Company Outlook

• Syndax is optimistic about the commercial prospects of Niktimvo and revumenib.
• The company is actively preparing for the launch of Niktimvo in early Q1 2025.
• Syndax anticipates reaching profitability backed by the royalty agreement and product launches.

Bearish Highlights

• The company has not applied for a breakthrough therapy designation for NPM1 due to insufficient Phase 1 data.
• There is no specific timeline provided for the conclusion of the HOVON trial data.

Bullish Highlights

• Syndax is advancing multiple clinical trials with positive data supporting the efficacy of its therapies.
• The royalty agreement with Royalty Pharma is expected to provide financial stability and support aggressive clinical advancement.

Misses

• The company is yet to achieve formulary inclusion for its drugs, which typically takes 9 to 12 months.

Q&A Highlights

• The company is confident in the robustness of the data submitted to the FDA for revumenib.
• There are no plans to update the KMT2A data beyond the 6.4-month duration observed in 97 patients.
• Syndax is preparing for several upcoming conferences to discuss further developments.

Syndax Pharmaceuticals has made significant strides in the third quarter of 2024, with the FDA approval of Niktimvo and the anticipated approval of revumenib by year-end positioning the company for strong market entry. The $350 million royalty agreement enhances Syndax's financial foundation, enabling aggressive clinical development. With $399.6 million in cash reserves and narrowed guidance for operating expenses, Syndax is on track to achieve profitability while addressing unmet medical needs in oncology treatments.

InvestingPro Insights

Syndax Pharmaceuticals' (NASDAQ: SNDX) recent earnings call aligns with key financial metrics and insights from InvestingPro. While the company's strong cash position supports ongoing clinical trials, investors should note it is currently "not profitable over the last twelve months," despite the anticipated revenue from product launches. InvestingPro's Fair Value for SNDX is estimated at $18.1 USD.

Full Transcript Highlights

Operator: Good day, everyone, and welcome to the Syndax Third Quarter 2024 Earnings Conference Call. Today's call is being recorded. All participants are in a listen-only mode. Sharon Klahre: Thank you for joining us today; I’m Sharon Klahre, head of Investor Relations at Syndax Pharmaceuticals. Michael Metzger: We made remarkable progress in Q3. With the announcement of a $350 million royalty agreement for Niktimvo with Royalty Pharma, we strengthened our balance sheet significantly and have the capital needed to fund our projects.

Niktimvo, recently approved by the FDA, is positioned to make a major impact on cGVHD treatment. Revumenib is also anticipated to gain FDA approval this December for acute leukemia. We are excited about the advancements in our clinical trials and the potential commercial success of both products.

Call Conclusion

The call opened for questions directed to top executives, covering topics like the anticipated approval timelines, market strategies, and competitive positioning in the oncology landscape. As the year concludes, Syndax is focused on maximizing its potential and fulfilling its mission in improving patient outcomes.