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NeuroPace(NPCE) - 2025 Q1 - Quarterly Results
2025-05-13 20:08
Financial Performance - Reported record quarterly revenue of $22.5 million in Q1 2025, a 24% increase from $18.1 million in Q1 2024[5] - RNS System revenue grew 26% year-over-year in Q1 2025, or 29% when excluding revenue from implants in the NAUTILUS study in Q1 2024[6] - Increased full-year 2025 revenue guidance to $93 million - $97 million, representing growth of 16% - 21% compared to $79.9 million in 2024[13] - Gross margin for Q1 2025 was 77.0%, exceeding the full-year guidance range of 73% - 75%[7] Operating Expenses and Losses - Operating expenses increased by 8% year-over-year to $22.5 million in Q1 2025, driven by R&D investments[8] - Loss from operations improved to $5.1 million in Q1 2025, compared to $7.5 million in the prior year[9] - Net loss for Q1 2025 was $6.6 million, down from $8.9 million in Q1 2024[9] Cash Position - Cash, cash equivalents, and short-term investments totaled $66.3 million as of March 31, 2025, up from $52.8 million at the end of the prior quarter[9] Strategic Focus - The company is on track to announce topline data from the NAUTILUS pivotal study in the second half of 2025[2] - Strategic refocusing on the core RNS System product line, with plans to wind down the distribution relationship for SEEG products by Q1 2026[6]
NeuroPace Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-13 20:05
Core Insights - NeuroPace, Inc. reported record quarterly revenue of $22.5 million in Q1 2025, a 24% increase from $18.1 million in Q1 2024, driven by strong demand for RNS System products [1][4][7] - The company raised its full-year 2025 revenue guidance to between $93 million and $97 million, representing a growth of 16% to 21% compared to $79.9 million in 2024 [1][13] - Management is on track to announce topline data from the NAUTILUS pivotal study in the second half of 2025 [1] Financial Performance - RNS System revenue grew 26% year-over-year in Q1 2025, or 29% when excluding revenue from implants in the NAUTILUS study in Q1 2024 [4][7] - Gross margin for Q1 2025 was 77.0%, exceeding the company's full-year guidance range of 73% to 75% [5][7] - Total operating expenses increased to $22.5 million in Q1 2025 from $20.9 million in the same period of the prior year, primarily due to increased R&D expenses [6][7] Strategic Initiatives - The company is focused on expanding into drug-resistant idiopathic generalized and pediatric focal epilepsy patient populations, along with launching differentiated software products in its AI pipeline [3] - NeuroPace is building awareness among clinicians and accelerating adoption of RNS therapy through its Project CARE initiative [3] - A strategic refocusing of the product portfolio on the core RNS System product line has been announced, with plans to wind down the distribution relationship for SEEG products starting in Q4 2025 [7] Operational Metrics - Loss from operations was $5.1 million in Q1 2025, an improvement from $7.5 million in the prior year [8] - The net loss for Q1 2025 was $6.6 million compared to $8.9 million in Q1 2024 [8] - Cash, cash equivalents, and short-term investments totaled $66.3 million as of March 31, 2025, up from $52.8 million at the end of the previous quarter [8]
Recent Price Trend in NeuroPace (NPCE) is Your Friend, Here's Why
ZACKS· 2025-05-13 13:50
Core Viewpoint - The article emphasizes the importance of identifying and maintaining trends in short-term investing, highlighting that sound fundamentals and positive earnings estimates are crucial for sustaining momentum in stocks [1]. Group 1: Stock Screening and Selection - The "Recent Price Strength" screen is a unique short-term trading strategy that helps identify stocks with strong fundamentals capable of maintaining an uptrend [2]. - NeuroPace, Inc. (NPCE) is highlighted as a suitable candidate that has shown a solid price increase of 8.6% over the past 12 weeks, indicating investor confidence [3]. - NPCE has experienced a significant price increase of 25.3% over the last four weeks, suggesting that the upward trend is still intact [4]. Group 2: Fundamental Analysis - NPCE is currently ranked 2 (Buy) by Zacks Rank, placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises [5]. - The Zacks Rank system has a strong track record, with Zacks Rank 1 stocks averaging an annual return of +25% since 1988, indicating the effectiveness of this ranking system [6]. - The Average Broker Recommendation for NPCE is 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term price performance [6]. Group 3: Investment Strategy - The article suggests that NPCE's price trend is unlikely to reverse soon, and encourages investors to explore other stocks that meet the criteria of the "Recent Price Strength" screen [7]. - The Zacks Research Wizard is mentioned as a tool for backtesting stock-picking strategies, which can help investors identify profitable opportunities based on historical performance [8].
NeuroPace Provides Update on Tariff Status
Globenewswire· 2025-04-14 20:05
Core Viewpoint - NeuroPace, Inc. expects minimal impact from U.S. tariffs on its operations and financial results, maintaining its gross margin guidance for fiscal year 2025 [1][2]. Group 1: Financial Performance - The company will report its first quarter 2025 financial results on May 13, 2025, with a conference call scheduled for the same day [3]. - NeuroPace anticipates no material impact on gross margin for its DIXI Medical SEEG products, reiterating its gross margin guidance for 2025 [2]. Group 2: Business Operations - NeuroPace manufactures and sells most of its devices in the U.S., with limited supply chain activities outside the country, which contributes to the expected minimal impact from tariffs [2]. - The company has announced the termination of its SEEG distribution agreement with DIXI Medical effective October 1, 2025, followed by a six-month wind-down period [2]. Group 3: Company Overview - NeuroPace is focused on transforming the lives of people with epilepsy through its RNS System, which is the first commercially available brain-responsive platform for personalized treatment [4].
NeuroPace Announces Data From a Long-Term Post-Approval Study of the RNS System in Focal Epilepsy at the 2025 AAN Annual Meeting
GlobeNewswire News Room· 2025-04-08 12:00
Core Insights - NeuroPace, Inc. announced three-year effectiveness data from the Post-Approval Study (PAS) of the RNS® System, showing an 82% median reduction in seizures for adults with drug-resistant focal epilepsy [1][6][7] - The data was presented at the American Academy of Neurology (AAN) Annual Meeting, highlighting the RNS System as the only FDA-approved device providing brain-responsive neurostimulation [2][3] Company Overview - NeuroPace is a medical device company focused on improving the lives of individuals with epilepsy through innovative solutions [5] - The RNS System is the first commercially available platform that delivers personalized, real-time treatment at the seizure source [5] Clinical Study Details - The PAS enrolled 324 patients across 32 centers, making it the largest FDA-reviewed, prospectively enrolled trial in neuromodulation for drug-resistant focal epilepsy [2][3] - The three-year effectiveness analysis indicated that 42% of patients remained seizure-free for over six months [6][7] Treatment Efficacy - The RNS System demonstrated a median seizure reduction of 62% at six months and 82% at three years [6][7] - The device provides greater seizure reduction compared to other neuromodulation therapies and is designed to offer personalized treatment [2][3]
NeuroPace Announces Upcoming Oral Presentation of Data from the Long-Term Post-Approval Study of the RNS System at the 2025 AAN Annual Meeting
Newsfilter· 2025-04-03 12:00
Core Viewpoint - NeuroPace, Inc. is focused on addressing the unmet medical needs of patients with drug-resistant focal epilepsy (DRE) through its innovative RNS® System, which will be presented at the AAN 2025 Annual Meeting [1][2]. Company Overview - NeuroPace is a commercial-stage medical device company based in Mountain View, California, dedicated to transforming the lives of people with epilepsy by reducing or eliminating debilitating seizures [5]. - The RNS System is the first and only commercially available brain-responsive platform that provides personalized, real-time treatment at the seizure source, aiming to improve care standards for patients with DRE [5]. Upcoming Events - NeuroPace will present data from the Post-Approval Study (PAS) of the RNS System at the AAN 2025 Annual Meeting in San Diego from April 5 to 9, with a specific oral presentation scheduled for April 7 [1][7]. - The RNS System will be showcased at booth 1642 during the event [2][4]. Leadership Insights - Joel Becker, CEO of NeuroPace, emphasized the significant unmet medical need for patients with DRE and expressed the company's commitment to improving outcomes for this population [2].
NeuroPace Announces Refocusing of Product Portfolio
Globenewswire· 2025-04-02 20:05
Core Viewpoint - NeuroPace, Inc. is strategically refocusing on its RNS System product line by terminating its distribution relationship for SEEG products, with the wind-down process starting in Q4 2025 and continuing into Q1 2026 [1][2][3] Financial Guidance - The company is maintaining its 2025 revenue guidance despite the upcoming changes, with expectations of achieving cash flow breakeven by the end of 2027 and a long-term revenue growth rate of over 20% CAGR [3][6] Product Strategy - The focus will shift towards expanding the RNS System's market presence, including initiatives like Project CARE and new indications for drug-resistant idiopathic generalized epilepsy and pediatric focal epilepsy [2][6] - The RNS System has a significantly higher gross margin of over 78% compared to the 50% margin for SEEG products, indicating a potential for improved profitability [6] Market Positioning - NeuroPace aims to establish the RNS System as the standard of care for drug-resistant epilepsy patients, leveraging its unique capabilities to drive long-term growth [3][5] - The company is confident in its ability to support customers during the transition away from SEEG products, as the SEEG market has comparable offerings from various competitors [6]
NeuroPace to Present at the 24th Annual Needham Virtual Healthcare Conference
Globenewswire· 2025-03-26 12:00
MOUNTAIN VIEW, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today announced that its management team will present at the 24th Annual Needham Virtual Healthcare Conference at 3:00pm ET (12:00pm PT) on Tuesday, April 8, 2025. Management will also host investor meetings during the conference. The presentation will be accessible via live webcast here. A webcast replay will be available for 90 ...
NeuroPace(NPCE) - 2024 Q4 - Earnings Call Transcript
2025-03-05 05:33
Financial Data and Key Metrics Changes - Total revenue for 2024 increased by 22% to $79.9 million compared to $65.4 million in 2023, with record quarterly revenue reported in Q4 [10][31] - Q4 2024 revenue was $21.5 million, representing a 19% growth compared to $18 million in Q4 2023, driven primarily by increased sales of the RNS system [30][31] - Gross margins for Q4 2024 were 75.4%, slightly up from 75.2% in Q4 2023, with improvements attributed to increased RNS product sales [31][34] Business Line Data and Key Metrics Changes - RNS system sales grew by 27% in Q4 2024, excluding contributions from Nautilus study cases in Q4 2023 [30] - Revenue from Dixie Medical products accounted for approximately 17% of total revenue in 2024, up from 15% in 2023 [31] Market Data and Key Metrics Changes - The core market opportunity within level four comprehensive epilepsy centers is estimated at approximately $2 billion annually [12] - The Project CARE initiative has begun to show positive trends, with increased implants and referrals contributing to revenue growth in the second half of 2024 [13][14] Company Strategy and Development Direction - The company’s growth strategy focuses on expanding adoption within level four comprehensive epilepsy centers, enhancing service delivery through Project CARE, and broadening indications for the RNS system [11] - Key development programs include ongoing clinical studies for idiopathic generalized epilepsy and pediatric focal epilepsy, with positive safety and effectiveness data expected to support regulatory approvals [15][17][20] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a revenue growth rate of over 20% annually over the next three years while aiming for cash flow breakeven [41] - The company anticipates total revenue for 2025 to be in the range of $92 million to $96 million, representing a 15% to 20% increase over 2024 [37] Other Important Information - The company completed a public offering that raised approximately $69.8 million, with $49.5 million used to repurchase shares from an early investor [35][26] - The cash and short-term investments balance as of February 28, 2025, is approximately $68.6 million, expected to support operations until achieving cash flow breakeven [36] Q&A Session Summary Question: Guidance for 2025 - Management discussed factors influencing revenue guidance, including execution of the three-part strategy and expansion of Project CARE [44][45] Question: Impact of Project CARE - Management noted meaningful impacts from Project CARE, with increased referrals and implants observed in Q4 [48] Question: Capital Prioritization - Management emphasized investment in expanding adoption within level four centers and direct-to-consumer efforts as key priorities for 2025 [52][54] Question: Gross Margin Trends - Management highlighted ongoing volume increases and pricing opportunities as primary drivers for gross margin improvement [58][61] Question: Indication Expansion and Reimbursement - Management confirmed established reimbursement for current indications and plans to work with payers to expand coverage for new indications [66] Question: Revenue Cadence for 2025 - Management expects a steady progression of growth throughout the year, similar to previous years [70] Question: Multiple Implants from New Accounts - Management confirmed seeing multiple implants and referrals from new accounts, indicating strong economic viability for RNS outside level four centers [75][76] Question: Pediatric Treatment Dynamics - Management explained that pediatric treatment dynamics would be similar to adult patients, focusing on the type of epilepsy rather than age [96] Question: Manufacturing Capacity - Management stated that manufacturing capacity is sufficient to meet anticipated demand [99] Question: Nautilus Study Data Presentation - Management plans to coordinate the publication and presentation of Nautilus data with relevant agencies and societies [105][108]
NeuroPace(NPCE) - 2024 Q4 - Earnings Call Transcript
2025-03-05 00:45
NeuroPace, Inc. (NASDAQ:NPCE) Q4 2024 Earnings Conference Call March 4, 2025 4:30 PM ET Company Participants Jeremy Feffer - Investor Relations Joel Becker - Chief Executive Officer and Board Member Rebecca Kuhn - Chief Financial Officer, Vice President, Finance and Administration Conference Call Participants Priya Sachdeva - UBS Rohin Patel - JP Morgan Frank Takkinen - Lake Street Capital Markets Mike Kratky - Leerink Partners Vik Chopra - Wells Fargo Matthew Park - Cantor Fitzgerald Michael Pollard - Wolf ...