NeuroOne® Product Revenue Increases 77% to $3.5 Million in Fiscal 2024: Expects Product Revenue to Increase at Least 132% to at Least $8 Million in Fiscal 2025
NeuroOne Medical Technologies (NMTC) reported significant growth in fiscal 2024, with product revenue increasing 77% to $3.5 million. The company expanded its exclusive distribution agreement with Zimmer Biomet, receiving a $3 million upfront payment in November 2024. For fiscal 2025, NeuroOne projects product revenue between $8-10 million, representing 132-190% growth, with expected gross margins of 47-51%, up from 31% in 2024.
The OneRF™ Ablation System has been implemented in 5 prominent epilepsy centers, with successful procedures on 12 patients. Operating expenses decreased 12% to $3.0 million in Q4 2024. The company remains debt-free, though cash position decreased to $1.5 million as of September 30, 2024, compared to $5.3 million the previous year.
NeuroOne Medical Technologies (NMTC) ha registrato una crescita significativa nel 2024, con un aumento del fatturato dei prodotti del 77% raggiungendo 3,5 milioni di dollari. L'azienda ha ampliato il suo accordo di distribuzione esclusivo con Zimmer Biomet, ottenendo un pagamento anticipato di 3 milioni di dollari a novembre 2024. Per l'anno fiscale 2025, NeuroOne prevede un fatturato dei prodotti compreso tra 8-10 milioni di dollari, rappresentando una crescita del 132-190%, con margini lordi attesi del 47-51%, rispetto al 31% nel 2024.
Il sistema di ablazione OneRF™ è stato implementato in 5 centri di epilessia di rilevanza, con procedure di successo su 12 pazienti. Le spese operative sono diminuite del 12%, attestandosi a 3 milioni di dollari nel quarto trimestre del 2024. L'azienda rimane senza debiti, sebbene la posizione di liquidità sia diminuita a 1,5 milioni di dollari al 30 settembre 2024, rispetto ai 5,3 milioni dell'anno precedente.
NeuroOne Medical Technologies (NMTC) reportó un crecimiento significativo en el año fiscal 2024, con un aumento del 77% en los ingresos por productos, alcanzando 3.5 millones de dólares. La compañía amplió su acuerdo de distribución exclusivo con Zimmer Biomet, recibiendo un pago inicial de 3 millones de dólares en noviembre de 2024. Para el año fiscal 2025, NeuroOne proyecta ingresos por productos entre 8-10 millones de dólares, lo que representa un crecimiento del 132-190%, con márgenes brutos esperados del 47-51%, en comparación con el 31% en 2024.
El sistema de ablación OneRF™ se ha implementado en 5 importantes centros de epilepsia, con procedimientos exitosos en 12 pacientes. Los gastos operativos disminuyeron un 12% a 3.0 millones de dólares en el cuarto trimestre de 2024. La compañía sigue sin deudas, aunque la posición de efectivo disminuyó a 1.5 millones de dólares al 30 de septiembre de 2024, en comparación con 5.3 millones del año anterior.
NeuroOne Medical Technologies (NMTC)는 2024 회계연도에 상당한 성장을 보고했으며, 제품 수익이 77% 증가하여 350만 달러에 달했습니다. 이 회사는 Zimmer Biomet와의 독점 유통 계약을 확대하며, 2024년 11월에 300만 달러의 선지급금을 받았습니다. 2025 회계연도에 대해 NeuroOne은 제품 수익이 800만-1000만 달러에 이를 것으로 예상하며, 이는 132-190%의 성장을 나타내며, 예상 총 이익률은 47-51%로 2024년 31%에서 증가할 것으로 보입니다.
OneRF™ 절제 시스템은 5개의 주요 간질 센터에 도입되어 12명의 환자에게 성공적인 시술이 이루어졌습니다. 운영비용은 2024년 4분기에 300만 달러로 12% 감소했습니다. 회사는 무부채 상태를 유지하고 있지만, 2024년 9월 30일 기준 현금 보유액은 150만 달러로 감소했으며, 이는 지난해 530만 달러에 비해 줄어든 것입니다.
NeuroOne Medical Technologies (NMTC) a enregistré une croissance significative au cours de l'exercice 2024, avec un chiffre d'affaires produit en hausse de 77%, atteignant 3,5 millions de dollars. L'entreprise a élargi son accord de distribution exclusif avec Zimmer Biomet, recevant un paiement initial de 3 millions de dollars en novembre 2024. Pour l'exercice 2025, NeuroOne projette un chiffre d'affaires produit entre 8-10 millions de dollars, représentant une croissance de 132-190%, avec des marges brutes attendues de 47-51%, en hausse par rapport à 31% en 2024.
Le système d'ablation OneRF™ a été mis en œuvre dans 5 centres d'épilepsie de premier plan, avec des procédures réussies sur 12 patients. Les dépenses d'exploitation ont diminué de 12% pour s'établir à 3 millions de dollars au quatrième trimestre 2024. L'entreprise reste sans dette, bien que sa position de trésorerie ait diminué à 1,5 million de dollars au 30 septembre 2024, contre 5,3 millions de dollars l'année précédente.
NeuroOne Medical Technologies (NMTC) berichtete über ein signifikantes Wachstum im Geschäftsjahr 2024, mit einem Anstieg der Produktumsätze um 77% auf 3,5 Millionen Dollar. Das Unternehmen hat seinen exklusiven Vertriebsvertrag mit Zimmer Biomet erweitert und einen 3 Millionen Dollar Vorschuss im November 2024 erhalten. Für das Geschäftsjahr 2025 prognostiziert NeuroOne Produktumsätze zwischen 8-10 Millionen Dollar, was einem Wachstum von 132-190% entspricht, mit einer erwarteten Bruttomarge von 47-51%, gegenüber 31% im Jahr 2024.
Das OneRF™ Ablationssystem wurde in 5 bedeutenden Epilepsiezentren implementiert, mit erfolgreichen Eingriffen an 12 Patienten. Die Betriebsausgaben sind im vierten Quartal 2024 um 12% auf 3,0 Millionen Dollar gesunken. Das Unternehmen bleibt schuldenfrei, obwohl die liquiden Mittel zum 30. September 2024 auf 1,5 Millionen Dollar gesunken sind, verglichen mit 5,3 Millionen Dollar im Vorjahr.
- Product revenue increased 77% to $3.5 million in FY2024
- Secured $3 million upfront payment from Zimmer Biomet partnership
- Projected revenue growth of 132-190% for FY2025 ($8-10 million)
- Expected gross margin improvement from 31% to 47-51% in FY2025
- Operating expenses decreased 12% to $3.0 million in Q4 2024
- Debt-free status maintained as of September 30, 2024
- Q4 2024 product revenue declined to $0.3M from $0.7M year-over-year
- Net loss increased to $12.3M in FY2024 from $11.9M in FY2023
- Cash position decreased to $1.5M from $5.3M year-over-year
- Working capital declined to $2.4M from $5.5M year-over-year
- Facing Nasdaq minimum bid price compliance issues
Insights
Company’s Exclusive Distribution Agreement with Zimmer Biomet included
EDEN PRAIRIE, Minn., Dec. 17, 2024 (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 fourth quarter and fiscal year ended September 30, 2024.
Fourth Quarter and Fiscal Year 2024 Financial Highlights
- Product revenue increased
77% to$3.5 million in fiscal year 2024, compared to$2.0 million in fiscal 2023. Revenue was lower in Q4 2024 versus a year ago due to NeuroOne’s cancellation of Zimmer Biomet’s order to transition manufacturing to strictly RF ablation-capable electrodes. - Operating expenses decreased
12% to$3.0 million in the fourth quarter of fiscal year 2024, compared to$3.4 million in the same quarter of the prior year. - Expanded exclusive distribution agreement with Zimmer Biomet (“Zimmer”) and received an upfront payment of
$3 million in November 2024. This agreement provides NeuroOne with additional milestone payments if certain performance criteria are achieved and is expected to generate meaningful revenue and expand margins for the Company. - Expects product revenue to range between
$8 and$10 million in fiscal year 2025, representing an increase of between132% and190% when compared to product revenue of$3.5 million in fiscal year 2024. - Expects product gross margin to range between
47% and51% in fiscal year 2025, compared to product gross margin of31% in fiscal year 2024. - The Company remains debt free as of September 30, 2024
Management Commentary
“This year was highlighted by our expanded partnership with Zimmer Biomet—one of the world’s largest medical device manufacturers—whereby they will exclusively distribute our OneRF™ Ablation System for use in the brain throughout the United States and certain international markets,” says Dave Rosa, CEO of NeuroOne. “Following receipt of a
We are also progressing discussions with other strategic partners regarding use cases for peripheral pain using our OneRF™ Ablation System, additional discussions regarding our technology to provide stimulation to treat pain, and our drug delivery system, which offers unique benefits to the pharmaceutical and biotech industry. Our strong product pipeline also includes the development of a new trigeminal nerve ablation product designed to treat patients with debilitating facial pain, which we plan to submit for a 510(k) application with the FDA in the first half of 2025.”
Operational Highlights and Updates
OneRF™ Ablation System:
- In October, NeuroOne expanded its strategic partnership with Zimmer Biomet to include exclusive commercialization rights for NeuroOne’s OneRF™ Ablation System for use in the brain in the United States and certain international markets.
- To-date, the OneRF™ Ablation System has performed RF ablation procedures on 12 patients, with up to 44 ablations per patient. Outcomes have been very positive, with all patients either seizure free or reporting significantly reduced and less severe seizures.
- Today, the OneRF Ablation System has been placed in 5 prominent epilepsy centers, and the Company is in discussions with 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:
- Finalized design concept.
- Finalized supply chain and initiated qualification process.
- FDA 510(k) submission expected in first half of fiscal year 2025, which could contribute to revenue in calendar year 2025.
Spinal Cord Stimulation (SCS) Percutaneous Paddle Lead Program:
- Optimized percutaneous delivery system with steerable capability.
- Confirmed successful placement of device in less than 5 minutes.
- The Company will work to complete an acute animal study to confirm full functionality of the NeuroOne percutaneous paddle lead system. Following completion of the acute study, a chronic study will be initiated.
sEEG-Based Drug Delivery Program:
- Completed design freeze of drug delivery cannula for enhanced delivery.
- Won “Best Operative Technique Poster” award at the CNS meeting in September for poster summarizing in vivo studies of NeuroOne’s sEEG-based drug delivery device.
Fourth Quarter and Fiscal Year 2024 Financial Results
Product revenue was
Total operating expenses decreased
Net loss was
In the fourth quarter of fiscal 2024, the Company completed a
As of September 30, 2024, the Company had cash and cash equivalents of
Following receipt of the
Full Fiscal Year 2025 Financial Guidance
The Company expects product revenue for fiscal year 2025 to range between
Nasdaq Compliance
The Company intends to continue actively monitoring the closing bid price for the Company’s common stock between now and January 7, 2025, and will consider available options to resolve the deficiency and regain compliance with Nasdaq’s minimum bid price requirement.
Conference Call and Webcast
Management will host an investor conference call and webcast today, Tuesday, December 17, 2024 at 9:00 a.m. Eastern time to discuss the Company’s fourth quarter and fiscal year 2024 financial results, provide a corporate update, and conclude with Q&A from telephone participants. To participate, please use the following information:
Date: Today, Tuesday, December 17, 2024
Time: 9:00 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 Fourth Quarter and Fiscal Year 2024 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 December 31, 2024. 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 December 17, 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 securing a strategic partnership for distribution of the OneRF™ Ablation System, 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 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 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 September 30, | ||||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 1,460,042 | $ | 5,322,493 | ||||
| Accounts receivable | 176,636 | — | ||||||
| Inventory | 2,635,153 | 1,726,686 | ||||||
| Deferred offering costs | 142,633 | — | ||||||
| Prepaid expenses | 216,461 | 263,746 | ||||||
| Total current assets | 4,630,925 | 7,312,925 | ||||||
| Intangible assets, net | 67,262 | 89,577 | ||||||
| Right-of-use asset | 254,910 | 169,059 | ||||||
| Property and equipment, net | 416,843 | 525,753 | ||||||
| Total assets | $ | 5,369,940 | $ | 8,097,314 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,029,206 | $ | 685,104 | ||||
| Accrued expenses and other liabilities | 1,184,014 | 1,107,522 | ||||||
| Total current liabilities | 2,213,220 | 1,792,626 | ||||||
| Warrant liability | 2,140,315 | — | ||||||
| Operating lease liability, long term | 194,392 | 55,284 | ||||||
| Total liabilities | 4,547,927 | 1,847,910 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 30,816 | 23,929 | ||||||
| Additional paid–in capital | 75,795,610 | 68,911,778 | ||||||
| Accumulated deficit | (75,004,413 | ) | (62,686,303 | ) | ||||
| Total stockholders’ equity | 822,013 | 6,249,404 | ||||||
| Total liabilities and stockholders’ equity | $ | 5,369,940 | $ | 8,097,314 | ||||
NeuroOne Medical Technologies Corporation
Statements of Operations
(unaudited)
| Years ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Product revenue | $ | 3,453,003 | $ | 1,952,441 | ||||
| Cost of product revenue | 2,373,336 | 1,495,924 | ||||||
| Product gross profit | 1,079,667 | 456,517 | ||||||
| Collaborations revenue | — | 1,455,188 | ||||||
| Operating expenses: | ||||||||
| Selling, general and administrative | 7,901,695 | 6,926,269 | ||||||
| Research and development | 5,065,181 | 6,940,686 | ||||||
| Total operating expenses | 12,966,876 | 13,866,955 | ||||||
| Loss from operations | (11,887,209 | ) | (11,955,250 | ) | ||||
| Fair value change in warrant liability | (327,092 | ) | — | |||||
| Financing costs | (228,988 | ) | — | |||||
| Other income, net | 125,179 | 95,759 | ||||||
| Loss before income taxes | (12,318,110 | ) | (11,859,491 | ) | ||||
| Provision for income taxes | — | — | ||||||
| Net loss | $ | (12,318,110 | ) | $ | (11,859,491 | ) | ||
| Net loss per share: | ||||||||
| Basic and diluted | $ | (0.46 | ) | $ | (0.65 | ) | ||
| Number of shares used in per share calculations: | ||||||||
| Basic and diluted | 26,762,392 | 18,121,108 | ||||||
FAQ
What is NeuroOne's (NMTC) revenue guidance for fiscal 2025?
How much did NMTC receive from the Zimmer Biomet partnership in 2024?
What are NMTC's projected gross margins for fiscal 2025?
How many epilepsy centers are currently using NMTC's OneRF Ablation System?
What was NMTC's net loss for fiscal year 2024?
