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- **Revenue Surge**: Q3 revenue up 21% to $45.9 million, driven by Revyforge ($32M, +12%) and Nictimvo ($45.8M, +27%).
- **Market Expansion**: FDA approval triples Revyforge’s addressable population; 50% of usage in second-line KMT2A.
- **Profitability Path**: $456M cash, stable expenses, confident in reaching profitability.
- **Clinical Excellence**: 79% response rate in real-world use, 100% MRD negativity in frontline trials.
- **Growth Drivers**: Post-transplant maintenance to offset transplant pauses; NPM1 launch on track for Q4 acceleration.

**【CEO Opening Remarks】**
- Q3 2025 total revenue of $45.9 million, up 21% quarter-over-quarter, driven by Revyforge and Nictimvo launches. Revyforge net revenue $32 million (12% QoQ growth), Nictimvo collaboration revenue $13.9 million. FDA approval for Revyforge in NPM1 AML triples addressable population; 50% of Revyforge usage in second-line KMT2A. $456 million cash, confident in reaching profitability with current funds.

**【Commercial Progress】**
- **Revyforge**: 25% QoQ growth in prescriptions/new starts; 35%-40% patients restarting post-transplant. 90% of KMT2A usage in second/third-line; 50% of patients proceed to transplant. NPM1 launch: 2,200+ prescriptions in first week, 97% formulary coverage.
- **Nictimvo**: $45.8 million net sales (27% QoQ), 80% of Q1 patients remain on therapy.

**【ASH Presentations】**
- **Revyforge**: 79% overall response rate in real-world KMT2A/NPM1; 86% MRD negativity in KMT2A. Frontline trial: 88% CR in NPM1/KMT2A, 100% MRD negative. Post-transplant maintenance: 100% 1-year EFS in pediatric review.
- **Nictimvo**: Positive safety and efficacy in chronic GVHD combination trials.

**【Financial Results】**
- **Revenue Breakdown**: Revyforge: $32 million (12% QoQ), 25% gross-to-net adjustments. Nictimvo: $13.9 million (27% QoQ), 25%-30% margin contribution.
- **Cash Position**: $456 million, sufficient for commercial and clinical execution.

**【Q&A Highlights】**
- **Lines of Therapy**: Revyforge used earlier in KMT2A (70% second-line), NPM1 expected to follow.
- **Duration of Therapy**: 4-6 months in 2025, 6-12+ in 2026 as post-transplant maintenance grows.
- **Payer Access**: 97% formulary coverage for KMT2A, rapid build for NPM1.
- **Competitive Edge**: Best-in-class efficacy, 1-year first-mover advantage in NPM1.

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

- **Revenue Surge**: Q2 2025 net sales of $64.8 million, driven by 43% QoQ growth in Revuforj and $36.2 million in Niktimvo revenue.
- **Market Dominance**: Revuforj treats 25% of annual KMT2A patients in 7 months, Niktimvo achieves 80% retention in GVHD.
- **Strategic Wins**: sNDA for NPM1 AML with October 2025 PDUFA date; Phase II IPF trial on track for 2026 data.
- **Profitability Path**: Niktimvo profitable in Q2, Revuforj on track for relapsed/refractory profitability with 4-6 month treatment durations.
- **Pipeline Momentum**: Frontline trials enrolling; Niktimvo advancing into GVHD earlier lines and IPF.

**【CEO Summary Section】**
- **Revenue Growth**: Revuforj and Niktimvo combined net sales reached $64.8 million in Q2, with Revuforj growing 43% QoQ to $28.6 million and Niktimvo reporting $36.2 million in net revenue.
- **Market Leadership**: Revuforj is the only FDA-approved therapy for relapsed/refractory KMT2A acute leukemia, treating over 500 patients (90% on-label) in 7 months. Niktimvo achieved 80% patient retention in chronic GVHD.
- **Strategic Expansion**: sNDA for Revuforj in mutant NPM1 AML with PDUFA date October 25, 2025. Frontline trials (EVOLVE-2 and REVEAL) for Revuforj in combination therapies are enrolling patients.
- **Pipeline Momentum**: Niktimvo advancing into IPF with Phase II trial enrollment expected to complete in Q4 2025.

**【CFO Financial Commentary】**
- **Profitability Path**: Niktimvo contributed $9.4 million in collaboration revenue (20-30% margin), with Revuforj on track for relapsed/refractory profitability. Full-year operating expenses guided at $370-390 million, stable through 2027.
- **Balance Sheet Strength**: $518 million in cash as of Q2, supporting launches and clinical development without dilution.
- **Revenue Drivers**: Revuforj expected to benefit from longer treatment durations (4-6 months in Q2, expanding to 6-12+ months) and post-transplant maintenance. Niktimvo's chronic nature supports multi-year patient adherence.

**【Q&A Highlights】**
- **Revuforj Transplant Rate**: 1/3 of KMT2A patients proceeded to transplant in Q2, higher than 1/4 in clinical trials. Physicians expect 70-90% of eligible patients to restart post-transplant.
- **FDA Confidence**: sNDA for NPM1 AML on priority review with PDUFA date October 25, 2025. Regulatory team reports positive engagement and no major issues.
- **Niktimvo Growth**: 70% of GVHD centers using Niktimvo, with 1,000+ patients treated. Phase II IPF trial targeting 135 patients, with data expected H2 2026.
- **Competitive Position**: Revuforj's best-in-class efficacy and first-to-market advantage in menin inhibition; Niktimvo's novel mechanism in GVHD.

Syndax Pharmaceuticals, Inc. (SNDX) Q2 2025 Earnings Call Transcript

- **Revenue Growth**: Q1 2025 net sales of $33.6 million for Revuforj and Niktimvo, exceeding expectations with strong commercial execution.
- **Pipeline Momentum**: Initiated EVOLV-2 trial and submitted sNDA for Revuforj, positioning for accelerated approvals.
- **Financial Resilience**: $602.1 million cash balance supports long-term growth and clinical expansion.
- **Market Leadership**: First-to-market advantage in menin inhibition with Revuforj, driving early adoption in relapsed AML.

**【CEO Summary Section】**
- **Revenue Performance**: Q1 2025 net revenue of $20 million for Revuforj and $13.6 million for Niktimvo, driven by strong commercial execution and unmet patient need.
- **Pipeline Advancements**: Initiated EVOLV-2 trial for frontline revumenib in unfit AML patients and submitted sNDA for Revuforj in mutant mNPM1 AML under FDA's RTOR program.
- **Financial Strength**: $602.1 million in cash, well-positioned for near-term profitability and future growth.

**【CFO Financial Commentary】**
- **Revenue Breakdown**: 50% share of Niktimvo net commercial profit resulted in $200,000 loss in Q1, with expectations for rapid conversion to positive contribution.
- **Cost Management**: Channel inventory maintained at 2-3 weeks, minimizing supply chain risk.
- **Liquidity**: Strong cash position supports ongoing operations and clinical development.

**【Commercial Progress】**
- **Revuforj Adoption**: 44% of high-priority accounts ordered by end of Q1, with 80% of prescribers reordering for additional patients.
- **Niktimvo Momentum**: Over 1,250 infusions administered in first two months, with 95% of top GVHD centers activated.

**【Pipeline Updates】**
- **EVOLV-2 Trial**: Amended to include complete remission and overall survival as dual primary endpoints for potential accelerated approval.
- **sNDA Submission**: Leveraging RTOR program for priority review, with potential for first-to-market approval in mutant mNPM1 AML.

**【Q&A Highlights】**
- **Revuforj Repeat Prescribers**: 80% of early prescribers reordered, with anecdotal evidence of post-transplant use.
- **Niktimvo Market Access**: 72% formulary coverage achieved, with J-code enabling efficient reimbursement.
- **EVOLV-2 Design**: Trial powered for NPM1 population, with dual endpoints to support accelerated approval pathways.

Syndax Pharmaceuticals (SNDX)-5 May 25-2025 Q1 Earnings call transcript

- **First-quarter revenue milestone**: $7.7 million in Revuforj sales highlight strong early demand and execution.
- **Strategic financing**: $350 million from Royalty Pharma underscores Niktimvo's multibillion-dollar potential.
- **Pipeline expansion**: sNDA for mutant NPM1 AML expected in Q2 2025, with frontline trials advancing.
- **Commercial momentum**: 33% of high-priority accounts ordering Revuforj, with Niktimvo targeting a $1.5-$2 billion market.
- **Financial strength**: $692 million in cash and no gross-to-net pressures support long-term growth.

**【CEO Summary Section】**
- Syndax reported $7.7 million in net revenue for Revuforj in Q4 2024, marking the first quarter with product revenue.
- The company secured a $350 million upfront payment from Royalty Pharma for a capped royalty on Niktimvo sales, reinforcing its financial position.
- Revuforj demonstrated strong early demand, with 33% of high-priority accounts ordering the drug, and plans to file an sNDA for mutant NPM1 AML by Q2 2025.
- Niktimvo launched in January 2025 for chronic GVHD, targeting a $1.5-$2 billion U.S. market opportunity.

**【CCO Commercial Progress】**
- Revuforj achieved $7.7 million in 5 weeks, with 1/3 of sales attributed to inventory and the remainder to patient demand.
- 33% of Tier 1 and Tier 2 accounts (representing 2/3 of patient opportunity) have ordered Revuforj, and most accounts have written multiple prescriptions.
- Niktimvo is being evaluated in combination trials with Jakafi and steroids, with IPF data expected in 2026.

**【R&D Updates】**
- Revuforj showed a 48% overall response rate in relapsed/refractory mutant NPM1 AML, with 23% achieving CR/CRh, supporting an sNDA submission in Q2 2025.
- A Phase II trial of Revuforj with venetoclax/azacitidine in frontline AML achieved a 100% overall response rate, with 95% MRD negativity.
- Frontline trials in both fit and unfit populations are planned for 2025, leveraging MRD as a potential endpoint.

**【CFO Financial Highlights】**
- Q4 2024 operating expenses were $104.0 million, with $65.5 million in R&D and $37.7 million in SG&A.
- Cash, equivalents, and investments totaled $692.4 million as of December 31, 2024.
- Niktimvo revenue will be split 50/50 with Incyte, with collaborative arrangement revenue or loss recognized based on commercial profit.

**【Q&A Key Takeaways】**
- Inventory levels are expected to remain at 2-3 weeks, with no significant gross-to-net adjustments.
- Revuforj is being used off-label in NPM1 and combination settings, with safety feedback positive.
- The company aims to be a leading specialty oncology company by 2030, with multiple commercial products and a robust pipeline.

Syndax Pharmaceuticals (SNDX)-3 Mar 25-2024 Q4 Earnings call transcript

Syndax Pharmaceuticals (SNDX)-5 Nov 24-2024 Q3 Earnings call transcript

Syndax Pharmaceuticals (SNDX)-1 Aug 24-2024 Q2 Earnings call transcript

Syndax Pharmaceuticals (SNDX)-8 May 24-2024 Q1 Earnings call transcript

- **Dual Regulatory Milestones**: Revumenib NDA submission under RTOR and axatilimab BLA with priority review (PDUFA: Aug 28, 2024). 
- **Commercial Expansion**: 2024 launch with 40-50 reps; $600M cash runway. 
- **Pipeline Growth**: Phase II IPF trial for axatilimab and Phase I colorectal cancer trial for revumenib. 
- **Market Opportunity**: $750M KMT2A AML market and 5,000 NPM1 AML patients. 
- **Financial Outlook**: 2024 OpEx $355-375M; ~$100M SG&A increase for sales force build.

**【CEO Summary Section】**
- **2023 Milestones**: Submitted NDA for revumenib under FDA's RTOR program for KMT2A acute leukemia and BLA for axatilimab in chronic GVHD with priority review (PDUFA: August 28, 2024). 
- **Commercial Strategy**: Planning 2024 launches with 40-50 reps covering both products; co-promoting axatilimab with Incyte (30% FTE contribution). 
- **Pipeline Expansion**: Phase II IPF trial for axatilimab and Phase I colorectal cancer trial for revumenib; exploring frontline AML combinations (revumenib + 7+3, venetoclax/azacitidine). 
- **Market Potential**: KMT2A AML ($750M US market) and NPM1 AML (~5,000 relapsed/refractory patients). 

**【CFO Financial Commentary】**
- **Q4 2023 Results**: $77.9M operating expenses ($55.1M R&D, $22.8M SG&A). 
- **2024 Guidance**: R&D $240-260M, OpEx $355-375M; $600M cash runway to 2026. 
- **Sales Force Build**: Hiring 40-50 reps for dual product coverage; ~$100M SG&A increase vs. 2023. 

**【Q&A Highlights】**
- **Launch Timing**: Revumenib PDUFA action date expected Q1; axatilimab launch Q3. 
- **Combo Trials**: Phase II 7+3 trial for frontline AML; Phase II axatilimab + ruxolitinib in chronic GVHD. 
- **IPF Trial Design**: 0.3mg/kg dose based on GVHD data; 135-patient trial targeting FVC decline. 
- **Safety Profile**: Revumenib no QTc prolongation; axatilimab minimal drug interactions. 
- **Colorectal Cancer**: Q2 2024 data readout for monotherapy activity in metastatic setting.

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