Earnings Labs

NeuroOne Medical Technologies Corporation (NMTC)

Q4 2024 Earnings Call· Tue, Dec 17, 2024

$4.75

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Transcript

Operator

Operator

Good day, ladies and gentlemen. Welcome to the NeuroOne Fourth Quarter and Fiscal Year-End 2024 Earnings Call. Today's call will be conducted by the company's Chief Executive Officer, Dave Rosa; and Ron McClurg, the company's Chief Financial Officer; Chris Volker, the company's Chief Operating Officer will also be in attendance. Before I turn the call over to Mr. Rosa, I'd like to remind you that this conference call will include forward-looking statements within the meaning of U.S. federal securities laws with respect to future operations, financial results, events, trends and performance, which are based on management's beliefs and assumptions as of today's call or other specified date. Forward-looking statements may involve known and unknown risks, uncertainties and other factors, which may cause actual results to differ materially from those expressed or implied by such statements. See NeuroOne's financial results press release and SEC filings for information regarding specific risks and uncertainties that could cause actual results to differ. Except as required by law, NeuroOne undertakes no obligation to update such forward-looking statements. With that, I will turn the call over to Mr. Dave Rosa, CEO of NeuroOne. Please go ahead, sir.

Dave Rosa

Management

Thanks, operator and good morning to everyone. During our fiscal fourth quarter and through today, we have continued to execute our plan and accomplished key milestones regarding commercialization, product development, and financial objectives. In 2024, our top priorities were to pursue a 510(k) clearance from the FDA, to market our OneRF Ablation System and to secure a strategic partnership for distribution. While there was risk associated with the 510(k) given there were no other devices with such a clearance, we successfully achieved this objective, as well as securing a strategic partnership to distribute the system. We are proud that the OneRF Ablation System is the first and only FDA cleared system with an intended use for both reporting electrical activity and ablation of nervous tissue utilizing the same device. Our recent announcement regarding the extension of the partnership with Zimmer Biomet provides a broad distribution network for both the U.S. and certain OUS geographies. In addition, NeuroOne received an upfront license payment of $3 million and the potential to earn an additional milestone payment if certain performance criteria are achieved. We expect the expanded partnership to boost NeuroOne sales and to drive improved profitability. With that confidence, we are excited to provide guidance for fiscal year 2025 for revenue of $8 million to $10 million, representing revenue growth of 132% to 190% over 2024. We are also projecting gross margins for fiscal year 2025 to range between 47% and 51%, compared to gross margins of 31% in 2024. We are very happy to be reporting strong annual revenue growth in fiscal 2024 and expect our revenue growth and margin improvement to accelerate in 2025. We have also been able to strengthen our balance sheet with the $3 million license payment from Zimmer Biomet along with the improved product gross margins…

Ron McClurg

Management

Thanks, Dave. Product revenue was $1.3 million in the fourth quarter of fiscal 2024, compared to $1.7 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 our manufacturing to the new OneRF product line. Product revenue increased 77% to $3.5 million in fiscal year ‘24, compared to $2 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 that were eligible for revenue recognition during fiscal year 2023. Our total operating expenses decreased 12% to $3 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 million in the full fiscal year 2024, compared to $13.9 million in fiscal year 2023. R&D expense increased -- decreased, excuse me 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 for the full fiscal year 2024, compared to $6.9 million in fiscal year 2023. Selling, general and administrative expense, or SG&A, 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 for the full fiscal year 2023. Our net loss was $3.3 million for the fourth quarter of fiscal ‘24, compared to a net loss of $3.1 million in the same period -- prior year fourth quarter. Our net loss for the…

Dave Rosa

Management

Thank you, Ron. In closing, we are very happy with the progress made in fiscal 2024 and are looking forward to driving accelerated revenue growth and margin improvement in 2025. We now have clear near-term growth drivers, as well as a strong product pipeline leveraging our novel platform technology. In the near-term, we are well positioned to drive meaningful revenue growth and margin improvement, having just completed the first shipments to Zimmer Biomet of the OneRF Ablation System, the first and only FDA clear device for RF Ablation in the brain. We also expect our trigeminal nerve indication to be commercialized potentially in calendar year 2025, and we are continuing to make progress on product development milestones and potential strategic partnerships for our drug delivery and spinal cord stimulation programs. I would like to thank everyone for attending the call and look forward to updating you on our progress next quarter.

Operator

Operator

This concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.

Q -

Management