Full Press Release Details
Reports First Quarter Fiscal Year 2025 Financial Results and Provides Corporate Update
Total revenue of $6.3M Includes $3.3
Million of Product Revenue in Addition to a One-Time Upfront Payment of $3.0 Million in License Revenue from Zimmer Biomet
EDEN PRAIRIE, Minn., February 12, 2025 --
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
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."
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.
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."
Highlights and Updates
Nerve Ablation Program:
Cord Stimulation (SCS) Percutaneous Paddle Lead Program:
Drug Delivery Program:
Quarter Financial Results
Product revenue was $3.3 million in
the first quarter of fiscal 2025, an increase of 235% compared to product revenue of $1.0 million in the first quarter of fiscal
2024. The Company had license revenue of $3.0 million in the first quarter of fiscal 2025, compared to no license revenue in the first
quarter of fiscal 2024. License revenue in the first quarter of fiscal 2025 was derived from the expanded exclusive distribution agreement
Product gross profit was $1.9 million, or
58.9% of revenue, in the first quarter of fiscal 2025, compared to product gross profit of $0.3 million, or 27.2% of revenue in the first
quarter of fiscal 2024.
Total operating expenses in the first quarter
of fiscal 2025 were $3.2 million, a decrease of 12% compared with $3.7 million in the first quarter of fiscal 2024. Research
& Development expense in the first quarter of fiscal 2025 was $1.2 million compared with $1.5 million in the same
period of fiscal 2024. Selling, General & Administrative expense in the first quarter of fiscal 2025 was $2.0 million compared
with $2.2 million in the first quarter of fiscal 2024.
For the first quarter of fiscal 2025, the
Company reported net income of $1.8 million, or $0.06 per share, compared to a net loss of $3.3 million, or $(0.14) per share, in
the first quarter of fiscal 2024.
As of December 31, 2024, the Company
had cash and cash equivalents of $1.1 million, compared to $1.5 million as of September 30, 2024. The Company had
working capital of $4.1 million as of December 31, 2024, compared to working capital of $2.4 million as of September 30, 2024. The Company
had no debt outstanding as of December 31, 2024. Following receipt of the $3.0 million license payment from Zimmer in November 2024,
the Company terminated the $3.0 million standby secured credit facility agreement without drawing on it.
Full Fiscal Year 2025 Financial Guidance
The Company continues to expect product revenue
for fiscal year 2025 to range between $8.0 million and $10.0 million, representing an increase of between 132% and 190% when compared
to product revenue of $3.5 million in fiscal year 2024. The Company continues to expect product gross margin in fiscal year 2025 to range
between 47% and 51%, compared to product gross margin of 31% in fiscal year 2024.
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
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
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.
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