NeuroOne® Reports First Quarter Fiscal Year 2025 Financial Results and Provides Corporate Update
NeuroOne Medical Technologies (NMTC) reported strong Q1 FY2025 results with total revenue of $6.3M, including $3.3M in product revenue (235% increase YoY) and a $3.0M upfront license payment from Zimmer Biomet. Product gross margin improved to 58.9% from 27.2% year-over-year, while operating expenses decreased 12% to $3.2M.
The company reported net income of $1.8M ($0.06 per share) compared to a net loss of $3.3M in Q1 FY2024. NeuroOne reaffirmed its FY2025 guidance, projecting product revenue between $8.0-10.0M (132-190% growth) and gross margins of 47-51%. The OneRF Ablation System has been placed in 5 prominent epilepsy centers, with positive patient outcomes reported.
The company remains debt-free with $1.1M in cash and $4.1M in working capital as of December 31, 2024. NeuroOne also regained compliance with Nasdaq's minimum share price requirements.
NeuroOne Medical Technologies (NMTC) ha riportato risultati solidi per il primo trimestre dell'anno fiscale 2025, con un fatturato totale di 6,3 milioni di dollari, di cui 3,3 milioni di dollari derivanti dalle vendite di prodotti (aumento del 235% rispetto all'anno precedente) e un pagamento anticipato di licenza di 3,0 milioni di dollari da Zimmer Biomet. Il margine lordo sui prodotti è migliorato, passando dal 27,2% al 58,9% su base annua, mentre le spese operative sono diminuite del 12%, arrivando a 3,2 milioni di dollari.
L'azienda ha riportato un utile netto di 1,8 milioni di dollari (0,06 dollari per azione) rispetto a una perdita netta di 3,3 milioni di dollari nel primo trimestre dell'anno fiscale 2024. NeuroOne ha confermato le previsioni per l'anno fiscale 2025, prevedendo un fatturato da prodotti compreso tra 8,0 e 10,0 milioni di dollari (crescita del 132-190%) e margini lordi tra il 47% e il 51%. Il OneRF Ablation System è stato installato in 5 centri di epilessia di rilievo, con esiti positivi riportati dai pazienti.
L'azienda rimane senza debiti, con 1,1 milioni di dollari in contante e 4,1 milioni di dollari in capitale circolante al 31 dicembre 2024. NeuroOne ha anche ripristinato la conformità con i requisiti minimi di prezzo delle azioni di Nasdaq.
NeuroOne Medical Technologies (NMTC) reportó resultados sólidos para el primer trimestre del año fiscal 2025, con ingresos totales de 6.3 millones de dólares, incluyendo 3.3 millones de dólares en ingresos por productos (aumento del 235% interanual) y un pago anticipado de licencia de 3.0 millones de dólares de Zimmer Biomet. El margen bruto de productos mejoró al 58.9% desde el 27.2% interanual, mientras que los gastos operativos disminuyeron un 12% a 3.2 millones de dólares.
La compañía reportó una ganancia neta de 1.8 millones de dólares (0.06 dólares por acción) en comparación con una pérdida neta de 3.3 millones de dólares en el primer trimestre del año fiscal 2024. NeuroOne reafirmó su guía para el año fiscal 2025, proyectando ingresos por productos entre 8.0 y 10.0 millones de dólares (crecimiento del 132-190%) y márgenes brutos del 47-51%. El OneRF Ablation System se ha instalado en 5 centros prominentes de epilepsia, con resultados positivos reportados por los pacientes.
La compañía se mantiene libre de deudas con 1.1 millones de dólares en efectivo y 4.1 millones de dólares en capital de trabajo al 31 de diciembre de 2024. NeuroOne también recuperó el cumplimiento con los requisitos mínimos de precio de acciones de Nasdaq.
NeuroOne Medical Technologies (NMTC)는 2025 회계연도 1분기 실적을 발표하며 총 수익 630만 달러를 기록했습니다. 이 중 330만 달러는 제품 수익으로, 전년 대비 235% 증가했습니다. 또한 Zimmer Biomet로부터 300만 달러의 선급 라이선스 지급을 받았습니다. 제품 총 마진은 전년 대비 27.2%에서 58.9%로 개선되었으며, 운영 비용은 12% 감소하여 320만 달러가 되었습니다.
회사는 2024 회계연도 1분기에서 330만 달러의 순손실에 비해 180만 달러의 순이익(주당 0.06달러)을 기록했습니다. NeuroOne은 2025 회계연도 가이던스를 재확인하며, 제품 수익을 800만~1000만 달러(132-190% 성장)로 예상하고 총 마진을 47-51%로 설정했습니다. OneRF Ablation System은 5개의 주요 간질 센터에 배치되었으며, 환자들의 긍정적인 결과가 보고되었습니다.
회사는 2024년 12월 31일 기준으로 110만 달러의 현금과 410만 달러의 운전 자본을 보유하고 있으며, 부채가 없습니다. NeuroOne은 또한 나스닥의 최소 주가 요건을 충족하였습니다.
NeuroOne Medical Technologies (NMTC) a annoncé de solides résultats pour le premier trimestre de l'exercice 2025, avec un chiffre d'affaires total de 6,3 millions de dollars, dont 3,3 millions de dollars de revenus de produits (augmentation de 235 % par rapport à l'année précédente) et un paiement anticipé de licence de 3,0 millions de dollars de Zimmer Biomet. La marge brute des produits a augmenté à 58,9 % contre 27,2 % d'une année sur l'autre, tandis que les dépenses d'exploitation ont diminué de 12 % pour atteindre 3,2 millions de dollars.
La société a déclaré un bénéfice net de 1,8 million de dollars (0,06 dollar par action) par rapport à une perte nette de 3,3 millions de dollars au premier trimestre de l'exercice 2024. NeuroOne a réaffirmé ses prévisions pour l'exercice 2025, prévoyant des revenus de produits compris entre 8,0 et 10,0 millions de dollars (croissance de 132 à 190 %) et des marges brutes de 47 à 51 %. Le OneRF Ablation System a été installé dans 5 centres d'épilepsie de premier plan, avec des résultats positifs rapportés par les patients.
La société reste sans dette avec 1,1 million de dollars en liquidités et 4,1 millions de dollars en fonds de roulement au 31 décembre 2024. NeuroOne a également retrouvé le respect des exigences minimales de prix des actions de Nasdaq.
NeuroOne Medical Technologies (NMTC) berichtete über starke Ergebnisse für das erste Quartal des Geschäftsjahres 2025 mit einem Gesamtumsatz von 6,3 Millionen Dollar, darunter 3,3 Millionen Dollar aus Produktumsätzen (235% Anstieg im Jahresvergleich) und einer Vorauszahlung von 3,0 Millionen Dollar von Zimmer Biomet. Die Bruttomarge für Produkte verbesserte sich von 27,2% auf 58,9% im Jahresvergleich, während die Betriebskosten um 12% auf 3,2 Millionen Dollar sanken.
Das Unternehmen berichtete über einen Nettogewinn von 1,8 Millionen Dollar (0,06 Dollar pro Aktie) im Vergleich zu einem Nettoverlust von 3,3 Millionen Dollar im ersten Quartal des Geschäftsjahres 2024. NeuroOne bekräftigte seine Prognose für das Geschäftsjahr 2025 und rechnet mit Produktumsätzen zwischen 8,0 und 10,0 Millionen Dollar (132-190% Wachstum) und Bruttomargen von 47-51%. Das OneRF Ablation System wurde in 5 bedeutenden Epilepsiezentren platziert, wobei positive Ergebnisse bei den Patienten berichtet wurden.
Das Unternehmen bleibt schuldenfrei und verfügt zum 31. Dezember 2024 über 1,1 Millionen Dollar in bar und 4,1 Millionen Dollar an working capital. NeuroOne hat außerdem die Einhaltung der Mindestaktienkursanforderungen von Nasdaq wiederhergestellt.
- Total revenue reached $6.3M, with product revenue up 235% YoY to $3.3M
- Product gross margin improved significantly to 58.9% from 27.2%
- Operating expenses reduced by 12% to $3.2M
- Achieved net income of $1.8M vs previous year's loss
- Secured $3.0M upfront license payment from Zimmer Biomet
- Regained Nasdaq compliance
- Debt-free status maintained
- Cash position decreased to $1.1M from $1.5M quarter-over-quarter
Insights
The Q1 FY2025 results mark a pivotal transformation for NeuroOne, showcasing the company's successful transition from R&D to commercial execution. The 235% year-over-year product revenue growth to
The expanded Zimmer Biomet partnership brings strategic advantages beyond the immediate
However, the
The reaffirmed FY2025 guidance of
Total revenue of
EDEN PRAIRIE, Minn., Feb. 12, 2025 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (“NeuroOne” or the “Company”), a medical technology company dedicated to transforming the surgical diagnosis and treatment of neurological disorders, has reported financial results for the first quarter fiscal year 2025 ended December 31, 2024.
First Quarter Financial Highlights
- Product revenue increased
235% to$3.3 million in the first quarter of fiscal year 2025, compared to$1.0 million in the first quarter of fiscal 2024. - Product gross margin increased to 58.9 % in the first quarter of fiscal year 2025, compared to
27.2% in the same quarter of the prior year. - Operating expenses decreased
12% to$3.2 million in the first quarter of fiscal year 2025, compared to$3.7 million in the same quarter of the prior year. - Expanded exclusive distribution agreement with Zimmer Biomet (“Zimmer”) and received an upfront license payment of
$3.0 million in November 2024. This agreement provides NeuroOne with a potential additional milestone payment if certain performance criteria are achieved and is expected to generate meaningful revenue and expanded margins for the Company. - The Company reaffirms its fiscal year 2025 guidance of product revenue, which excludes license revenue, to range between
$8.0 t o$10.0 million , representing an increase of between132% and190% when compared to product revenue of$3.5 million in fiscal year 2024. - The Company reaffirms its fiscal year 2025 guidance of product gross margin to range between
47% and51% , compared to product gross margin of31% in fiscal year 2024. - The Company remains debt free as of December 31, 2024.
Management Commentary
“This quarter marks the next step forward in expanding our commercialization efforts as we continue executing on our strategic partnership with Zimmer Biomet,” said Dave Rosa, CEO of NeuroOne. “Early patient successes reinforce the clinical value of the OneRF Ablation System, the first and only FDA-cleared device that performs both recording and RF ablation in the brain using the same device. We expect this momentum to translate into broader market adoption and a strong revenue profile which will allow us to advance our product portfolio and drive shareholder value.”
Mr. Rosa continued,” We remain on track to submit a 510(k) application to the FDA in the first half of calendar year 2025 for our new trigeminal nerve radiofrequency ablation system designed to treat patients with debilitating facial pain.
We are also pleased that we have regained compliance with Nasdaq’s share price listing standards and are grateful to our shareholders for their patience during this time.”
Operational Highlights and Updates
OneRF® Ablation System:
- Expanded exclusive distribution agreement with Zimmer for NeuroOne’s OneRF® Ablation System for use in the brain in the United States and certain international markets.
- Completed initial stocking order to Zimmer.
- To date, outcomes have been very positive, with all patients either seizure free or reporting significantly reduced and less severe seizures. The patient that has experienced the longest freedom from seizures post-surgery is now beyond 9 months.
- Today, the OneRF Ablation System has been placed in 5 prominent epilepsy centers, with sales discussions initiated at an additional 18 centers nationwide.
- In October, the new code for the OneRF®™ ablation procedure went into effect (the ICD-10-PCS, or “International Classification of Diseases, 10th Revision, Procedure Coding System”), allowing hospital reporting of inpatient procedures that are performed using the OneRF® Ablation System ensuring efficient and accurate documentation, billing and analysis.
Trigeminal Nerve Ablation Program:
- FDA 510(k) submission expected in first half of calendar year 2025, which could contribute to revenue in calendar year 2025.
Spinal Cord Stimulation (SCS) Percutaneous Paddle Lead Program:
- Completed an acute animal study to confirm full functionality of the current NeuroOne percutaneous paddle lead system.
- Exploring collaboration opportunities with potential strategic partners to further develop and commercialize our Percutaneous Paddle Lead.
sEEG-Based Drug Delivery Program:
- Presented poster at annual meeting of American Epilepsy Society highlighting feasibility of our sEEG-based drug delivery system.
- Initiated system miniaturization for use of sEEG-based drug delivery system in small animal clinical research.
- Continuing discussions with potential strategic partners.
First Quarter Financial Results
Product revenue was
Product gross profit was
Total operating expenses in the first quarter of fiscal 2025 were
For the first quarter of fiscal 2025, the Company reported net income of
As of December 31, 2024, the Company had cash and cash equivalents of
Full Fiscal Year 2025 Financial Guidance
The Company continues to expect product revenue for fiscal year 2025 to range between
Nasdaq Compliance
On February 3rd, the Company received notification that it has regained compliance with the Nasdaq Capital Market’s continued listing standard for the minimum share price requirements under Nasdaq Listing Rule 5550(a)(2).
Conference Call and Webcast
Management will host an investor conference call and webcast today, Wednesday, February 12, 2025, at 8:30 a.m. Eastern Time to discuss the Company’s first quarter fiscal year 2025 financial results, provide a corporate update, and conclude with Q&A from telephone participants. To participate, please use the following information:
Date: Today, Wednesday, February 12, 2025
Time: 8:30 a.m. Eastern time
U.S. Dial-In (Toll Free): 888-506-0062
International Dial-In: 973-528-0011
Participant Access Code: 603219
Webcast: NMTC First Quarter Fiscal Year 2025 Earnings Conference Call
Please join at least five minutes before the start of the call to ensure timely participation.
A playback of the call will be available through [date], 2025. To listen, please call 877-481-4010 within the United States or 919-882-2331 when calling internationally, using replay passcode 51728. A webcast replay will also be available using the webcast link above through [date], 2025.
About NeuroOne
NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) is developing and commercializing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that may improve patient outcomes and reduce procedural costs. The Company may also pursue applications for other areas such as depression, mood disorders, pain, incontinence, high blood pressure, and artificial intelligence. For more information, visit nmtc1.com.
Forward Looking Statements
This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in this press release may be a forward–looking statement that reflects NeuroOne’s current views about future events and are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward–looking statements by the words or phrases “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “forecasts,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue, “focused on,” “committed to” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward–looking statements may include statements regarding the addition of new centers for the Company’s limited commercial launch of the OneRF™ Ablation System, potential strategic partnership opportunities, continued development of the Company’s electrode technology program (including our drug delivery program and spinal cord stimulation program), fiscal year 2025 guidance, including expectations for significant product revenue growth and margin expansion, plan to submit a 510(k) application with the FDA in the first half of calendar 2025 for our trigeminal nerve ablation program, business strategy, market size, potential growth opportunities, future operations, future efficiencies, and other financial and operating information. Although NeuroOne believes that we have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Our actual future results may be materially different from what we expect due to factors largely outside our control, including risks related to whether the Company will continue to maintain compliance with all Nasdaq continued listing requirements, risks that our strategic partnerships may not facilitate the commercialization or market acceptance of our technology; whether due to supply chain disruptions, labor shortages or otherwise; risks that our technology will not perform as expected based on results of our pre-clinical and clinical trials; risks related to uncertainties associated with the Company’s capital requirements to achieve its business objectives and ability to raise additional funds: the risk that we may not be able to secure or retain coverage or adequate reimbursement for our technology; uncertainties inherent in the development process of our technology; risks related to changes in regulatory requirements or decisions of regulatory authorities; that we may not have accurately estimated the size and growth potential of the markets for our technology; risks relate to clinical trial patient enrollment and the results of clinical trials; that we may be unable to protect our intellectual property rights; and other risks, uncertainties and assumptions, including those described under the heading “Risk Factors” in our filings with the Securities and Exchange Commission. These forward–looking statements speak only as of the date of this press release and NeuroOne undertakes no obligation to revise or update any forward–looking statements for any reason, even if new information becomes available in the future.
Caution: Federal law restricts this device to sale by or on the order of a physician.
IR Contact
MZ Group – MZ North America
NMTC@mzgroup.us
NeuroOne Medical Technologies Corporation
Balance Sheets
(unaudited)
| As of | ||||||||
| December 31, | September 30, | |||||||
| 2024 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 1,134,350 | $ | 1,460,042 | ||||
| Accounts receivable | 2,368,913 | 176,636 | ||||||
| Inventory | 1,930,861 | 2,635,153 | ||||||
| Deferred offering costs | 82,962 | 142,633 | ||||||
| Prepaid expenses | 194,699 | 216,461 | ||||||
| Total current assets | 5,711,785 | 4,630,925 | ||||||
| Intangible assets, net | 61,683 | 67,262 | ||||||
| Right-of-use asset | 339,271 | 254,910 | ||||||
| Property and equipment, net | 381,711 | 416,843 | ||||||
| Total assets | $ | 6,494,450 | $ | 5,369,940 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 744,525 | $ | 1,029,206 | ||||
| Accrued expenses and other liabilities | 826,386 | 1,184,014 | ||||||
| Total current liabilities | 1,570,911 | 2,213,220 | ||||||
| Warrant liability | 1,750,870 | 2,140,315 | ||||||
| Operating lease liability, long term | 237,377 | 194,392 | ||||||
| Total liabilities | 3,559,158 | 4,547,927 | ||||||
| Commitments and contingencies (Note 4) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 30,841 | 30,816 | ||||||
| Additional paid–in capital | 76,123,542 | 75,795,610 | ||||||
| Accumulated deficit | (73,219,091 | ) | (75,004,413 | ) | ||||
| Total stockholders’ equity | 2,935,292 | 822,013 | ||||||
| Total liabilities and stockholders’ equity | $ | 6,494,450 | $ | 5,369,940 | ||||
NeuroOne Medical Technologies Corporation
Statements of Operations
(unaudited)
| For the three months ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| Product revenue | $ | 3,274,167 | $ | 977,649 | ||||
| Cost of product revenue | 1,347,278 | 711,335 | ||||||
| Product gross profit | 1,926,889 | 266,314 | ||||||
| License revenue | 3,000,000 | — | ||||||
| Operating expenses: | ||||||||
| Selling, general and administrative | 2,043,454 | 2,173,472 | ||||||
| Research and development | 1,172,228 | 1,483,317 | ||||||
| Total operating expenses | 3,215,682 | 3,656,789 | ||||||
| Income (loss) from operations | 1,711,207 | (3,390,475 | ) | |||||
| Fair value change in warrant liability | 389,445 | — | ||||||
| Financing cost | (324,738 | ) | — | |||||
| Other income | 9,408 | 45,575 | ||||||
| Income (loss) before income taxes | 1,785,322 | (3,344,900 | ) | |||||
| Provision for income taxes | — | — | ||||||
| Net income (loss) | $ | 1,785,322 | $ | (3,344,900 | ) | |||
| Net income (loss) per share: | ||||||||
| Basic | $ | 0.06 | $ | (0.14 | ) | |||
| Diluted | $ | 0.06 | $ | (0.14 | ) | |||
| Number of shares used in per share calculations: | ||||||||
| Basic | 30,837,524 | 23,995,610 | ||||||
| Diluted | 30,880,415 | 23,995,610 | ||||||
FAQ
What was NeuroOne's (NMTC) revenue growth in Q1 FY2025?
What is NMTC's product revenue guidance for fiscal year 2025?
How many epilepsy centers are currently using NMTC's OneRF Ablation System?
What was NMTC's gross margin improvement in Q1 FY2025?
When will NMTC submit its FDA 510(k) application for the trigeminal nerve ablation system?
