NeuroOne Medical Technologies Corporation Price & Performance (NMTC)

Dave Rosa, CEO of NeuroOne, Thanks, operator. For those of you who may be new to NeuroOne, we are a medical technology company that is dedicated to transforming the diagnosis and treatment of neurological disorders. Initially with epilepsy, where we have minimally invasive, high definition solutions, for EEG recording, brain stimulation and ablation solutions for patients. Our patented and disruptive 1RF ablation system the first and only FDA cleared product that uses the same SEE GLA for both diagnostic and therapeutic applications is performing extremely well in treating patients suffering from seizures due to epilepsy. We hope to expand the number of patients willing to opt for this therapy given it is designed to reduce the number of hospitalizations and procedures while improving outcomes. During our fiscal first quarter and through today, we have continued to execute our plan and have accomplished several key milestones regarding commercialization, product development, and financial objectives. I am very proud to report that we have achieved record product sales of $3,300,000 as well as record product gross margins of 58.9% in the first quarter This represents revenue growth of 235% when compared to revenue of $1,000,000 in the first quarter of fiscal twenty twenty four and almost double our product gross margins which were 27% in the first quarter of fiscal twenty twenty four.

The strong financial performance is a result of the deepening partnership with Zimmer Biomet. As a reminder, our relationship with Zimmer Biomed began in 2020 and in October 2024, we announced the expansion of our partnership with Zimmer Biomed to include exclusive distribution rights for the 1RF ablation system in The United States and certain outside U. S. Geographies. In consideration for the expanded partnership, NeuroOne received an upfront license payment of $3,000,000 and the potential to earn an additional milestone payment if certain performance criteria are achieved. Combined, we are reporting total first quarter revenue of $6,300,000 also a record for NeuroOne. The expanded partnership with Zimmer Biomed includes improved transfer prices and is expected to boost NeuroOne revenue and to drive improved profitability given their extensive distribution network and scale. Regarding the launch of the 1RF ablation system, we completed the initial stocking orders to Zimmer Biomet during the first quarter. Zimmer Biomet is one of the largest global medical device companies in The United States, and has a strong presence in the epilepsy market. There are approximately 200 Level four epilepsy centers in The United and Zimmer's robotic system is used in the majority of the epilepsy performed each year For NeuroOne, we believe the relationship positions us for significant growth and provides a faster timeline to mass adoption.

We are pleased to report that in all but one of the one RF ablation procedures performed to date, the patients are seizure free. However, that one patient has experienced a significant reduction in seizure occurrence and less severe seizures after the 1RF ablation procedure was performed. We are especially happy to report that one of the patients has now been seizure free for over nine months following the 1RF ablation procedure. Enabling the patient to enjoy significant improvement and quality of life. These exciting results confirm that this technology is a game changer. Instead of patients having to undergo two hospitalizations with multiple procedures that are typically a few months apart, With the 1RF ablation system, they can now undergo one hospitalization that allows the neurosurgeon to use the same electrode for both diagnostic and ablation purposes. As noted, our 1RF ablation system remains the first and only FDA cleared RF ablation system for brain procedures using a single implant for both diagnostic and therapeutic applications. Creating a unique competitive and a first mover advantage. Hospitals are increasingly favoring FDA cleared solutions over off label alternatives. Second, physicians are more inclined to use an approved system reducing liability concerns.

And lastly, patients are more trusting of approved technology. Also important to hospitals, the new ICD-ten PCS code granted by CMS for the 1RF ablation procedure became effective October 1, 2024, which will allow hospitals to report inpatient procedures that are performed using the 1RF ablation system. This will serve to support accurate data collection and processing of reimbursement claims by hospitals for the procedure. Leveraging our ablation system, to treat pain in other areas of the body, we remain on track to submit a five ten application to the FDA in the first half of calendar year 2025 for our new trigeminal nerve RF ablation system. Designed to treat patients with debilitating facial pain also known as trigeminal neuralgia, The trigeminal nerve is located in the face with one nerve on each side of the face. Trigeminal neuralgia is a chronic pain condition and is characterized by severe sudden and recurrent facial pain with over one hundred and fifty thousand patients diagnosed each year in The United States. Neuroone trigeminal nerve RF ablation system has the potential to contribute to revenue and calendar year 2025 that is not currently factored in our 2025 revenue plan nor our revenue guidance.

With regard to our other product development programs, leveraging our thin film electrode platform technology, we are continuing to make progress exploring potential strategic partnerships to further develop and commercialize our spinal cord stimulation, and drug delivery technologies, both of which would benefit Immensely from the multifunction capabilities that NeuronOne's technology can offer. Before I turn it over to Ron, I would also like to comment on a few financial updates. We are off to a great start with our financial results in the first quarter. And with this confidence, we are reiterating our fiscal year twenty twenty five guidance. We expect product revenue to be in the range of $8,000,000 to $10,000,000 representing an increase of between 132190% over 2024 and product gross margins to be between 4751% compared to 31% in 2024. Importantly, this guidance excludes our upfront license payments received from Zimmer. Additionally, we have been able to strengthen our balance sheet in the first quarter with a $3,000,000 license payment from Cimber Biomed along with the improved transfer prices from the expanded Zimmer partnership, driving improved product gross margins. Finally, I am also pleased to announce that we have regained compliance with NASDAQ share price listing standards and are grateful to all of our shareholders for their patience during this time.

I would now like to turn the call over to Ron McClurg, provide a review of our fiscal first quarter financial results. Ron? Thanks, Dave. Product revenue was $3,300,000 in the first quarter of fiscal twenty twenty five, an increase of 235% compared to our product revenue of $1,000,000 in first quarter of fiscal twenty twenty four. The company also had license revenue of $3,000,000 in the first quarter of fiscal twenty twenty five, compared to no license revenue in the first quarter of fiscal twenty twenty four. License revenue in the first quarter of fiscal 'twenty five was derived from the expanded exclusive distribution agreement with Zimmer Biomet. Product gross profit increased significantly to $1,900,000 or 50% to 8.9% of revenue in the first quarter of fiscal twenty twenty five compared to product gross profit of $300,000 dollars or 27.2% of revenue in the first quarter of fiscal twenty twenty four. Total operating expenses in the first quarter of fiscal twenty twenty five were $3,200,000 a decrease of 12% compared to $3,700,000 in the first quarter of fiscal twenty twenty four. R and D expense in the first quarter of fiscal twenty twenty five decreased to $1,200,000 compared to $1,500,000 in the same period of fiscal twenty twenty four.

SG and A expense in the first quarter of fiscal twenty twenty five also decreased to $2,000,000 compared to $2,200,000 in the first quarter of fiscal twenty twenty four. For the first quarter of fiscal twenty twenty five, company reported net income As of 12/31/2024, the company had cash and cash equivalents of $1,100,000 compared to $1,500,000 as of 09/30/2024. The company had working capital of $4,100,000 as of 12/31/2024, compared to working capital of $2,400,000 as of 09/30/2024. Company had no debt outstanding as of December 3120 Following receipt of the $3,000,000 license payment from Zimmer Biomet in November of twenty twenty four, the company terminated the $3,000,000 standby secured credit facility agreement. For the full fiscal year 2025, Given that we recently completed the initial stacking order to Zimmer in December, we expect product revenue will decline sequentially in the second quarter of fiscal twenty twenty five and then ramp through the end of the fiscal year as the product launch expands. As Dave mentioned, the company is reiterating fiscal year 2025 guidance expects product revenue for fiscal year twenty twenty five to range between $8,000,000 and $10,000,000 representing an increase of between 132190% when compared to product revenue of $3,500,000 in fiscal year twenty twenty four. [indiscernible] The company also expects product gross margin in the full fiscal year 2025 to range between 4751% compared to product gross margin of 31% in fiscal twenty twenty four. [indiscernible] Operator, at this time, I think we can open up for questions.

Certainly. At this time, we will be conducting a question and answer session.

Hi, everyone, and congratulations on a great quarter. I'd like to just ask a few questions that were submitted. Dave, maybe first off, why have your results been so positive to date? And what is the measuring stick for clinical success for epilepsy? Sure. So it's been a preferred therapy for patients that have epilepsy to actually use ablation technology, whether it's radiofrequency ablation or laser ablation for those patients that are resistant to pharmacologic therapy, it's been the preferred method. So I'm not surprised that we're having success But the success we're having, I think part of the reason is that we're using the same device to both do the diagnostic procedure as well as the therapeutics. So So typically within a week, the diagnostic process is able to determine precisely the tissue that's triggering the seizures and given the fact that we're not sending the patient home and replacing the device when they come back a few months later, we're doing this really all in one hospitalization. I think it it certainly contributes to the success that we're having. The measuring stick for epilepsy patients, typically what you'll see in the clinical literature is that it's the timeline is one year either one year post surgery seizure free or improved dramatically improved reduction in seizures.

So as we mentioned in the discussion, Right now, the patient that's been treated the longest is a bit beyond nine months. So it'll be interesting to see over the course of the next twelve months many of those patients remain seizure free? Or are dramatically improved, but we're off to a great start with that.

Great. Thank you. And the second one is you reported a really strong product gross margin of almost 60% in Q1 and your guidance for the year is expected to range between 4751%. Do you think these levels of margin are sustainable long term?

I'm very confident that the margins of 47% to 51% are sustainable. The reason why we saw a higher gross margin in Q1 was if you remember, prior to finalizing the agreement, the extension with Zimmer Biomed, NeuroOne was actually commercializing the technology directly. And because of that, our margins were higher. But We're very confident and really expect those margins to be within the range that we provided in guidance and that's 47% to 51%.

Thank you. And the final question is, what does Neuro-one have to do before submitting the five ten application for facial pain? And as a follow-up, how long is the expected FDA review for that?

It's always a tough question determine how long it's going to take to get through FDA clearance. But the good news here is that we've said we expect to submit it in the first half of calendar twenty twenty five and we're certainly still on track with that There is some remaining testing that we have to perform things like sterilization testing, packaging, that's really required to be included in the FDA submission. But the good news here is that we've actually already kicked off the process of putting the application together for the submission. And in terms of the expected FDA review and the timing of that, I guess what I would say is our last submission, which was for the 1RF ablation system in the brain, That took about five months from the time we submitted to the time that we actually received clearance. So So assuming we stay on track and we submit this by mid year, I would expect that it would probably be somewhere in that range. Of what we've experienced before. But it's not a guarantee, but we've had great success, especially with our ablation system for the use of the brain.

Excellent. Congrats on a great quarter.

Thank you.

Thank you. We have reached the end of the question and answer session. And I would now like to turn the call back to Dave for closing remarks. Thank you, operator. In summary, this was a transformational quarter for Neuroone.

We delivered record revenue implemented and executed on our strategic partnership with Zimmer Biomet and continued building momentum in the market. With our first mover advantage, growing clinical adoption we are well positioned for significant full fiscal year 2025 growth. We are happy to reiterate our guidance for both product revenue and product gross margin for the full fiscal year 2025 as mentioned during the session. The potential to commercialize our trigeminal nerve RF ablation system in late calendar year twenty twenty five represents our next growth driver and we are continuing to make progress on longer term product development programs leveraging our platform technology. I would like to again thank everyone for attending the call. And we look forward to connecting with the investor community throughout the next quarter.

Thank you. This does conclude today's conference. We thank you for your participation. You may disconnect your lines at this time and have a wonderful day. [indiscernible]