NeuroPace (NPCE) 2025 Conference Transcript

Summary of NeuroPace Conference Call Company Overview - Company: NeuroPace (NPCE) - Focus: Development of implantable devices for treating drug-resistant epilepsy patients - Key Product: Responsive Neurostimulation (RNS) system, which monitors and tailors neurostimulation for individual patients [3][4] Market Size and Patient Demographics - Epilepsy Patients in the U.S.: Approximately 3.6 million diagnosed with epilepsy - Drug-Resistant Patients: About 1.2 million patients (one-third) do not respond satisfactorily to anti-seizure medications [5][6] - Comprehensive Epilepsy Centers (CECs): 75,000 patients per year treated at level four CECs, with recent regulatory approval allowing RNS implantation in level three community settings [8][9] Competitive Landscape - Focal Drug-Resistant Epilepsy: 60% of drug-resistant patients have focal epilepsy; RNS is currently indicated for this group - Generalized Drug-Resistant Epilepsy: 40% of patients are generalized; NeuroPace is conducting the NAUTILUS trial to gain indications for this population [11][12] RNS Technology - Unique Features: RNS monitors seizure activity and provides stimulation only when needed, leading to better patient outcomes compared to other devices that operate on a fixed duty cycle [14][15] - Clinical Data: Median seizure reduction rates improved from 50-60% to over 80% post-approval, with low adverse event rates [17][21] Data Utilization and Partnerships - Data Asset: NeuroPace has 22 million individualized seizure records, which can be used for algorithm development and insights into brain physiology [19][20] - Collaborations: Partnerships with Rapport Therapeutics and UCB to utilize RNS data in clinical trials for new therapies [24] Project Care Initiative - Objective: Increase access to RNS by moving into community settings and educating healthcare professionals and patients [27][34] - Progress: High referral rates and total implants reported, with ongoing efforts to raise awareness about RNS [27][28] NAUTILUS Trial Update - Trial Focus: Evaluating RNS for idiopathic generalized epilepsy (IGE) patients, specifically those experiencing generalized tonic-clonic seizures (GTC) [37][38] - Results: Met primary safety endpoint; secondary endpoints showed nearly 80% reduction in GTC seizures at one year [40][41] - Regulatory Engagement: Ongoing discussions with the FDA regarding trial results and potential approval [44][49] Financial Outlook - Growth Projections: Anticipated growth of at least 20% over the next few years, with gross margins approaching 80% by 2026 [52][54] - Cash Flow Breakeven: Expected in 2027, with additional growth from expanded indications [53][54] Conclusion - Overall Sentiment: NeuroPace is optimistic about its growth trajectory, product pipeline, and the potential impact of its RNS technology on the epilepsy treatment landscape [55][56]