NeuroOne Medical Technologies Corporation (NMTC), a medical technology company, has announced significant progress in its commercialization and product development efforts during the first quarter of fiscal year 2024. The company's Chief Financial Officer, Ron McClurg, led the earnings call in the absence of CEO Dave Rosa, who is recovering from minor surgery. NeuroOne's recent achievements include receiving FDA clearance for its OneRF Ablation System and the expanded launch of its Evo sEEG electrode product line with commercialization partner Zimmer Biomet.
Key Takeaways
- NeuroOne received FDA clearance for the OneRF Ablation System in December 2023 and is preparing for a limited commercial launch in Q2 of calendar year 2024.
- The company is in discussions with potential strategic partners for licensing the OneRF technology for brain ablation procedures and is also considering direct commercialization.
- Zimmer Biomet has continued to open new centers for the Evo sEEG electrode product line, with positive customer feedback and increasing usage.
- NeuroOne's Drug Delivery Program has demonstrated feasibility in benchtop testing and animal studies for delivering therapies to the brain.
- The company's Spinal Cord Stimulation Program to treat chronic back pain has advanced with successful placement of a paddle electrode in a cadaver model.
- Financial results show an increase in product revenue to $978,000 in Q1 FY2024, up from $115,000 in Q1 FY2023, but a decrease in collaboration revenue and an increase in net loss compared to the previous year.
Company Outlook
- NeuroOne is exploring additional market opportunities for the OneRF System, particularly in pain treatment.
- The company is optimistic about adding revenue in 2024 and beyond, not only from sEEG sales but also from the OneRF commercial launch and potential drug delivery partnerships.
Bearish Highlights
- Collaboration revenue in Q1 FY2024 was non-existent compared to $1,455,000 in Q1 FY2023.
- The net loss increased to $3.3 million in Q1 FY2024 from $1.7 million in Q1 FY2023.
- Cash and short-term investments decreased to $2.7 million as of December 31, 2023, from $5.3 million as of September 30, 2023.
Bullish Highlights
- Product revenue increased significantly year-over-year.
- The company successfully completed training for Zimmer Biomet's full sales force, which is expected to drive sales growth.
- NeuroOne has no debt outstanding as of December 31, 2023.
Misses
- The company reported no collaboration revenue for the quarter, which was a significant component of the previous year's revenue.
Q&A Highlights
- The company is addressing RF generator part delays and expects to receive the first units by the end of March, with a limited product launch following in the second quarter.
- There are no current barriers to the full launch of the Evo sEEG sales, with Zimmer Biomet's full sales force now trained and hospital value analysis committee approvals underway.
- Discussions with potential strategic partners for the OneRF Ablation System are ongoing, with a decision expected in the near term to determine the commercialization strategy.
NeuroOne's CFO concluded the call by expressing confidence in the company's trajectory and the potential for revenue growth in the coming year, driven by new product launches and strategic partnerships. The company will continue to update its stakeholders on its progress.
InvestingPro Insights
NeuroOne Medical Technologies Corporation (NMTC) has been actively working toward commercializing its innovative medical technologies. As the company navigates through its development phase, certain financial metrics and analyst observations can provide investors with a deeper understanding of its current position and future prospects.
InvestingPro Data indicates that NeuroOne holds a market cap of approximately $27.22 million USD, showcasing its status as a small-cap company in the medical technology sector. The company does not have a positive P/E ratio, reflecting its current lack of profitability, with the latest figures showing a P/E ratio (adjusted) for the last twelve months as of Q1 2024 at -2.08. Additionally, the Price / Book ratio for the same period stands at a high 6.34, which could suggest the stock is valued quite richly in terms of its net assets.
InvestingPro Tips highlight that while NeuroOne holds more cash than debt on its balance sheet, which is a positive sign of financial stability, the company is rapidly depleting its cash reserves. This is evident from the decline in cash and short-term investments reported in the article. Moreover, analysts do not expect the company to be profitable this year, aligning with the reported increase in net loss and the absence of collaboration revenue in the recent quarter.
There are 9 additional InvestingPro Tips available for NMTC at https://www.investing.com/pro/NMTC, which can provide investors with further insights into the company's financial health and stock performance. For those interested in accessing these tips, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
The company's recent FDA clearance and product launches present potential growth opportunities, yet the financial data and analyst tips suggest that investors should closely monitor NeuroOne's cash burn and profitability outlook as it progresses through its commercialization phase.
Full transcript - Neuroone Medical (NMTC) Q1 2024:
Operator: Good day, ladies and gentlemen, and welcome to the NeuroOne Medical Technologies Corporation First Quarter of Fiscal Year 2024 Financial Results Conference Call. Today's call will be conducted by the company's Chief Financial Officer, Ron McClurg. Before I turn the call over to Mr. McClurg, 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. Ron McClurg, CFO of NeuroOne. Please go ahead, sir.
Ron McClurg: Thank you, operator. Before I begin, I wanted to mention that Dave Rosa, our CEO, had minor surgery, which prevented him from being able to present this afternoon, so I will be handling the call. During the first quarter of fiscal 2024, we continued to make significant progress on our objectives relating to commercialization and product development. First, I would like to remind the audience of our recent milestone achievement of receiving FDA clearance for our OneRF Ablation System, the first FDA cleared system with an intended use for both recording electrical activity and ablation of nervous tissue utilizing the same device. As previously noted, we submitted a 510(k) application to the FDA in June 2023 for the OneRF Ablation System and we received 510(k) clearance from the FDA in December of 2023 for the creation of radio frequency lesions and nervous tissue for functional neurosurgical procedures. We are very excited to be the first to market this novel technology in the United States and are preparing to initiate a limited commercial launch in the second quarter of calendar 2024. We will remain in discussions with potential, strategic partners regarding the licensing of the technology for brain ablation procedures and we expect to reach a decision in the near future regarding our commercialization strategy. We also remain open to commercializing the device directly if we believe it represents the best option for the company and we are working in parallel on a plan to launch the technology directly. In addition, our team is exploring other applications for the OneRF System to treat pain. We believe that there are additional market opportunities for the OneRF System that we may be able to address and we will provide further updates in the future. I would now like to provide an update regarding the expanded launch of our Evo sEEG electrode product line with our commercialization partner, Zimmer Biomet. Zimmer continued to strategically open new centers during our first fiscal quarter. Customer feedback remains positive regarding device performance and we are seeing usage picking up in recent months. We completed full salesforce training for Zimmer in January 2024 and we expect to see an increase in Evo sEEG sales and revenue as the launch expands. We believe the launch of the OneRF system will also have a positive impact on customer demand for the Evo sEEG electrode product line. Moving on to our Drug Delivery Program. We have discussed the potential for our sEEG electrode technology to deliver drugs or gene therapies to the brain as well as record the therapy's impact. During the past quarter, we completed feasibility benchtop testing and an animal study demonstrating the ability to deliver a therapy and provide recording capabilities using the sEEG drug delivery system. We are currently in contract discussions with a biotech company regarding their interest in using our device in upcoming clinical studies and have had discussions with other potential partners. We are excited with the prospects of this technology and how it may assist the biopharma industry in their drug or gene therapy delivery development and also, its value clinically in current neurosurgical procedures. If we are able to reach an agreement in our current contract negotiations, the technology has the potential to add revenue later in calendar year 2024. Development efforts with our Spinal Cord Stimulation Program to treat chronic back pain continued in our first quarter as members of our Physician Advisory Board, successfully placed a 9-millimeter paddle electrode, utilizing a percutaneous placement approach in a cadaver model. Paddle electrodes are similar in concept to cortical or film electrodes. In addition, we completed a preclinical study of the first acute electrophysiology experiment with NeuroOne's lead in a sheep model. Spinal cord stimulation and pain management remain a priority, given the size of the market opportunity and the potential competitive advantages of our technology. I would now like to provide a review of our first quarter fiscal year 2024 financial results. Product revenue was $978,000 in the first quarter of fiscal 2024 compared to product revenue of $115,000 in the first quarter of fiscal 2023. The company had no collaboration revenue in the first quarter of fiscal 2024 compared to collaboration revenue of $1,455,000 in the first quarter of fiscal 2023. Collaboration revenue in 2023 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 the period. Total operating expenses in the first quarter of fiscal 2024 were $3.7 million, compared to $3.2 million in the first quarter of fiscal 2023. R&D expense in the first quarter of fiscal 2024 was $1.5 million, compared with $1.6 million in the same period of fiscal 2023. SG&A expense in the first quarter of fiscal 2024 was $2.2 million, compared to $1.7 million in the first quarter of fiscal 2023. The net loss was $3.3 million for the first quarter of fiscal 2024, compared to a net loss of $1.7 million in the first quarter of fiscal 2023. In December of 2023, the company sold common stock under the ATM offering at an average price of a $1.45 per share and received net proceeds of $1.2 million. As of December 31, 2023, the company had cash, cash equivalents and short-term investments of $2.7 million, compared to $5.3 million as of September 30, 2023 our previous fiscal year-end. The company had working capital of $3.7 million as of December 31, 2023, compared to working capital of $5.5 million as of September 30, 2023. The company had no debt outstanding as of December 31, 2023. Subsequent to the end of the first quarter in January of 2024, the company sold additional common stock under the ATM offering at an average price of a $1.46 per share and received net proceeds of $1.54 million. Operator, at this time, I think we can open up for questions.
Operator: Absolutely. Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] The first question comes from Alex Nowak with Craig-Hallum. Please proceed.
Unidentified Analyst: Hey, good afternoon. This is Connor on for Alex. Thanks for taking my questions. Could you maybe speak on the RF generator parts? I know last quarter you mentioned that was one of the hold ups in getting some of these systems placed. Any update on that would be great.
Ron McClurg: One of the – I think what we may have mentioned in the past was that there were some long lead time components and that was the gating factor for us in terms of when we could launch a limited release of the device and we’ve got those components on order. We are expecting to receive our first units of the hardware, the RF generator itself by the end of March. And so we’re looking at beginning a very limited launch of the product in the second calendar quarter of this year.
Unidentified Analyst: Got you. And then, maybe can you speak on any initial impact on Evo sEEG sales following the OneRF approval? I know you mentioned a step-up and then maybe when can we start seeing Zimmer to fully start launching Evo? Or is there any barriers preventing this full launch?
Ron McClurg: There are no barriers at this time that are preventing the full launch. The other than – when we initiated the limited launch, we only trained a portion of their sales force. So as I mentioned during the call, in January, so just last month, we attended their national sales meeting and trained their full distribution network, including distributors and direct employees. And one of the things that is kind of gating the rollout is their approval by the value analysis committee at each of the hospitals. So that is underway right now. They've got a targeted launch. They're trying to do this in a methodical manner and continue to add new accounts as we go forward.
Unidentified Analyst: Great. And then one more here. Could you speak towards the progress on maybe a potential partnership? Could this be within the year time span, less or more? I know you mentioned direct as well.
Ron McClurg: Well, we are in discussions right now with a couple of potential strategic partners and we would – if those come to fruition, we will then distribute the RF ablation – the OneRF Ablation System through that distributor. If we do not get terms that are favorable or acceptable to the company, we are prepared to go and start distribution on our own. And that's what I meant when I said we are kind of – we have a dual path right now that we are operating under so that we don't delay regardless of which direction we go. We do want to – yes, we do want to make that decision before we proceed with the limited launch. So we should have that decision made here in the near-term.
Unidentified Analyst: Gotcha, great. Thank you.
Ron McClurg: Thank you, Connor.
Operator: Okay. We have no further questions in queue. I will now turn the call back over to management for any closing remarks.
Ron McClurg: Yes. Thank you, operator. I would just like to say that the company is making great progress toward our goals for fiscal 2024. We're excited by the FDA clearance of the OneRF Ablation System and pleased with the expansion of Zimmer Biomet's launch of the Evo sEEG electrode and the related increase in revenue. We continue to make progress on our Drug Delivery program and our Spinal Cord Stimulation program intended to treat chronic back pain. Altogether, we believe NeuroOne has the potential to add revenue in 2024 and beyond just sEEG sales, with contributions coming from the OneRF commercial launch and potential drug delivery partnerships. We hope you will continue to follow our exciting progress. Thank you.
Operator: This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.
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