Full Press Release Details
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
Company's Exclusive Distribution
Agreement with Zimmer Biomet included $3.0 Million Upfront Payment: Expected to Drive Revenue and Expand Margins Significantly
EDEN PRAIRIE, Minn., December 17, 2024 --
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
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 $3 million upfront payment in November, we are now working closely with
Zimmer's team to complete training and prepare for their launch in the next few weeks. Going forward, we expect this partnership
to increase revenues and expand margins significantly. To that end, we expect revenues to increase to at least $8 million in fiscal year
2025-representing a year-over-year increase of at least 132%-and gross margins to expand from 31% in fiscal year 2024 to at
least 47% in fiscal year 2025.
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:
Trigeminal Nerve Ablation Program:
Spinal Cord Stimulation (SCS) Percutaneous
Paddle Lead Program:
sEEG-Based Drug Delivery Program:
Fourth Quarter and Fiscal Year 2024 Financial
Product revenue was $0.3 million in the fourth
quarter of fiscal 2024, compared to $0.7 million in the prior year fourth quarter. The reduction in product revenue in the fourth quarter
of fiscal 2024 was due to the Company's cancellation of a Zimmer Biomet purchase order in order to transition manufacturing to the
new OneRF product line. Product revenue increased 77% to $3.5 million in fiscal year 2024, compared to $2.0 million in fiscal year 2023.
The Company also had collaboration revenue of $1.5 million in fiscal 2023, which was derived from the Zimmer Development Agreement and
represents the portion of the exclusivity and milestone fee payments eligible for revenue recognition during fiscal year 2023.
Total operating expenses decreased 12% to $3.0
million in the fourth quarter of fiscal year 2024, compared with $3.4 million in the prior year fourth quarter. Total operating expenses
decreased 6% to $13.0 million in fiscal year 2024, compared to $13.9 million in fiscal year 2023. R&D expense decreased 39% to $1.1
million in the fourth quarter of fiscal 2024, compared to $1.8 million in the prior year fourth quarter. R&D expense decreased by
27% to $5.1 million in fiscal year 2024, compared to $6.9 million in fiscal year 2023. SG&A expense was $1.8 million in the fourth
quarter of fiscal 2024, compared to $1.6 million in the prior year fourth quarter. SG&A expense was $7.9 million in fiscal year 2024,
compared to $6.9 million in fiscal year 2023.
Net loss was $3.3 million for the fourth quarter
of fiscal 2024, compared to a net loss of $3.1 million in the same prior year fourth quarter. Net loss in fiscal year 2024 was $12.3 million,
compared to a net loss of $11.9 million in fiscal year 2023.
In the fourth quarter of fiscal 2024, the Company
completed a $2.65 million private placement of its common stock and entered into a $3.0 million secured credit facility agreement.
As of September 30, 2024, the Company had cash
and cash equivalents of $1.5 million, compared to $5.3 million as of September 30, 2023. The Company had working capital of $2.4 million
as of September 30, 2024, compared to working capital of $5.5 million as of September 30, 2023. The Company had no debt outstanding as
of September 30, 2024.
Following receipt of the $3.0 million payment
from Zimmer Biomet in November 2024, the Company terminated the $3.0 million secured credit facility agreement.
Full Fiscal Year 2025 Financial Guidance
The Company expects product revenue for fiscal
year 2025 to range between $8 million and $10 million, representing an increase of between 132% and 190% when compared to product revenue
of $3.5 million in fiscal year 2024. The Company expects product gross margin in fiscal year 2025 to range between 47% and 51%, compared
to product gross margin of 31% in fiscal year 2024.
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.
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