Financial Data and Key Metrics Changes - In the first quarter of 2025, the company reported revenue of $6.7 million, a 23% increase compared to $5.4 million in the first quarter of 2024 [7][23] - Gross margins improved to 85% in Q1 2025 from 84% in Q1 2024 [7][24] - GAAP net loss for Q1 2025 was $3.9 million, compared to a net loss of $3.5 million in Q1 2024 [26] - Cash and cash equivalents totaled approximately $8 million as of March 31, 2025, down from approximately $12.2 million at the end of 2024 [27] Business Line Data and Key Metrics Changes - Prescription gammaCore VA revenue grew 22% to $4.7 million in Q1 2025 from $3.9 million in Q1 2024 [8] - TRUVEGA net sales reached approximately $1.1 million, a 187% increase from the previous year [10] - Revenue from channels outside the United States increased to $513,000 in Q1 2025 from $449,000 in the same period last year [14] Market Data and Key Metrics Changes - The VA Hospital Administration estimates around 600,000 patients are treated for headaches in the VA system, with a significant number of fibromyalgia patients also identified [9] - The company has dispensed gammaCore devices to approximately 9,500 veterans, representing about 1.6% of the total addressable headache market within the VA system [9] Company Strategy and Development Direction - The company is transforming into a broader bioelectronic technology firm, with a focus on medical devices and wellness products [5] - The acquisition of the Quell product line from Neurometrics Inc. is a key component of this transformation [5][17] - The company plans to evaluate market access through third-party payer systems and hospital networks for its prescription product suite [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about returning to sequential growth in core prescription channels and highlighted the strong demand for gammaCore in the VA channel [30] - The company anticipates that operating metrics will improve as revenues grow and one-time expenses decrease [30] - Management expects to achieve cash neutrality with quarterly revenue of about $9 million by the end of 2025 or early 2026 [17] Other Important Information - The company incurred additional one-time expenses for severance related to internal restructuring and the acquisition of Neurometrics [15] - The company plans to launch TRUVEGA in the UK and Canada later in 2025 [14] Q&A Session Summary Question: What are the expected margins for Quell by the end of the year? - Management is optimistic that overhead absorption will be better than the previous structure, aiming for margins above 60% but cannot provide precise estimates yet [40][41] Question: Any concerns about tariff exposure for Quell components? - Management believes there is minimal tariff exposure as most components are sourced domestically, with some from Southeast Asia [42] Question: How should growth be modeled for top-line revenues? - Management expects mid to high single-digit sequential growth in the VA channel, potentially accelerating into the teens as new products are added [50] Question: What is the expected contribution from the new acquisitions? - Material revenue contributions from Sparrow are expected to be more of a 2026 story, while Quell is anticipated to generate revenue once manufacturing is validated [61][63] Question: What are the plans for R&D spending? - R&D expenses are expected to remain steady, focusing on sales support and data related to PTSD and traumatic brain injury [65]

Financial Data and Key Metrics Changes - In the first quarter of 2025, the company reported revenue of $6.7 million, a 23% increase compared to $5.4 million in the same quarter of 2024 [22][6] - Gross margins improved to 85% in Q1 2025 from 84% in Q1 2024 [6][23] - GAAP net loss for Q1 2025 was $3.9 million, compared to a net loss of $3.5 million in Q1 2024 [24][26] - Cash and cash equivalents totaled approximately $8 million as of March 31, 2025, down from approximately $12.2 million at the end of 2024 [26] Business Line Data and Key Metrics Changes - Prescription gammaCore VA revenue grew 22% to $4.7 million in Q1 2025 from $3.9 million in Q1 2024 [7] - TRUVEGA net sales reached approximately $1.1 million, a 187% increase from the previous year [10] - Revenue from channels outside the United States increased to $513,000 in Q1 2025 from $449,000 in the same period last year [14] Market Data and Key Metrics Changes - The VA Hospital Administration estimates around 600,000 patients are treated for headaches in the VA system, with a significant number of fibromyalgia patients also identified [8][9] - The company has dispensed gammaCore devices to approximately 9,500 veterans, representing about 1.6% of the total addressable headache market within the VA system [9] Company Strategy and Development Direction - The company is transforming into a broader bioelectronic technology firm, focusing on medical devices and wellness products, with the acquisition of the Quell product line from Neurometrics being a key component [4][5] - The company aims to leverage established distribution channels, particularly in the VA hospital system, to accelerate the adoption of new products like Quell and Sparrow [20][32] - Plans to launch TRUVEGA in the UK and Canada later in 2025 are underway [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about returning to sequential growth in core prescription channels and highlighted the positive momentum in both VA and direct-to-consumer channels [27][28] - The company anticipates that operating metrics will improve as revenues grow and one-time expenses decrease [28][33] - Management expects to achieve cash neutrality with quarterly revenue of about $9 million by the end of 2025 or early 2026 [16] Other Important Information - The company incurred additional one-time expenses for severance related to internal restructuring and the acquisition of Neurometrics [15] - The contribution margin of incremental revenue is approximately 65% with the current product mix [16] Q&A Session Summary Question: What are the expected margins for Quell by the end of the year? - Management indicated that while precise estimates are not available yet, they are optimistic that margins will be well above 60% once manufacturing is restarted [38][39] Question: How does cash look after the Neurometrics acquisition? - Cash levels are expected to remain similar to those reported as of March 31, with the acquisition costs primarily covered by cash on Neurometrics' balance sheet [43] Question: What is the growth outlook for top-line revenues? - Management expects mid to high single-digit sequential growth in the VA channel, potentially accelerating into the teens as new products are introduced [48] Question: How is the company expanding its sales efforts in the VA hospital system? - The company is adding headcount to its sales function to increase support in the VA hospital system, with a focus on new products [50][52] Question: What are the early results from selling TRUVEGA on Amazon? - Initial sales through Amazon have been promising, with a few hundred units sold, and the company is optimistic about future growth [56][57]

Core Viewpoint - Spark Biomedical is advancing in the field of non-invasive wearable neurostimulation technology, particularly through its transcutaneous auricular neurostimulation (tAN®) method, which is gaining traction as a viable alternative to traditional drug therapies in managing chronic health issues [3][4][5]. Group 1: Company Overview - Spark Biomedical was founded in 2018 and is headquartered in Dallas, Texas, focusing on non-invasive wearable neurostimulation technology [3][13]. - The company's core technology, tAN®, delivers mild electrical pulses through the skin of the ear to stimulate the vagus and trigeminal nerves, activating the central nervous system to alleviate discomfort and maintain physiological balance [3][4]. - The representative product, Sparrow Ascent, has received FDA approval for alleviating opioid withdrawal symptoms and is applicable to both adults and newborns suffering from neonatal abstinence syndrome [5][13]. Group 2: Recent Developments - On April 30, 2025, Spark Biomedical completed a $15 million A round financing, which will be used to accelerate product development and clinical expansion in key areas such as neuro health, hemostasis, and women's health [1][8]. - The financing reflects ongoing market interest in non-drug, non-invasive neuroregulation therapies amid rising chronic disease management needs and the opioid crisis [1][8]. Group 3: Clinical Applications and Research - Spark Biomedical is expanding its clinical applications of tAN® beyond opioid withdrawal to include hemostasis, women's health, pediatric care, and chronic pain management [9][11]. - The company has established a research platform called Sparrow Link, collaborating with institutions like Battelle Memorial Institute and Hazelden Betty Ford Foundation to advance neurostimulation research [6][12]. Group 4: Technological Advancements - The company is developing an AI-driven closed-loop neurostimulation system that dynamically monitors patients' neural responses and adjusts stimulation parameters for enhanced treatment precision [10][12]. - This system aims to assist in the detection and intervention of cravings during opioid withdrawal, supported by funding from the National Institutes of Health (NIH) and the National Institute on Drug Abuse (NIDA) [10][12]. Group 5: Strategic Collaborations - Spark Biomedical has formed strategic partnerships with various organizations, including the U.S. Department of Defense, to explore the potential applications of tAN® technology in behavioral health and battlefield medicine [6][12][16]. - These collaborations provide essential support for technology validation, regulatory pathways, and market entry, enhancing the company's long-term competitiveness in the global bioelectronic therapy market [12][16].