Welcome to the electroCore Third Quarter 2026 Earnings Conference Call. At this time, all participants have been placed in listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. Earlier today, electroCore published results for the third quarter ended September 30, 2026, and the press release is available on the company's website. Before we begin, I would like to remind everyone that members on the call will make forward-looking statements within the meaning of the federal securities laws made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical facts should be deemed to be forward-looking, including without limitation any guidance, the company's outlook on fourth quarter and full-year performance, and its path to profitability.
These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated. For a list of risk factors, please see the company's filings with the Securities and Exchange Commission, including but not limited to the current report on 8-K and Form 10-Q filed today with the SEC. electroCore disclaims any obligation to update these statements, except as required by law. This call contains time-sensitive information accurate only as of today, November 4, 2026. Joining us on today's call from electroCore are Dr. Thomas Errico, one of the company's Founders, Investor, and Independent Chairman of the Board of Directors; Joshua Lev, Co-Chief Executive Officer, President, and Chief Financial Officer; and Mike Fox, Co-Chief Executive Officer, President, and Chief Operating Officer. It is now my pleasure to turn the call over to Dr. Thomas Errico, electroCore's Founder and Independent Chairman, for opening remarks. Dr. Errico.
Thank you, operator. Good afternoon, everyone, and thank you for joining electroCore's third quarter 2026 earnings call. This quarter was about strengthening the foundation, leadership, commercial execution, and regulatory clarity. The results strengthen my conviction and excitement about the company's current trajectory. This was a record quarter for electroCore, our highest net sales and our smallest operating loss in company history. Behind those results, management is building a commercial organization designed to grow profitably at a much larger scale. As with any transformation, the changes have been significant, and we believe the changes we have executed have established a foundation that positions electroCore for accelerated growth and an inflection point in positive adjusted EBITDA in 2027. For me, one of the most exciting developments is our progress opening new markets.
On October 27, we filed our 510(k) pre-market notification with the FDA seeking clearance for our Quell wearable neural stimulation device for the treatment of chemotherapy-induced peripheral neuropathy, or CIPN. This submission comes on the back of the Breakthrough Device Designation from the FDA in January 2022, which covers the reduction of moderate to severe symptoms of chemotherapy-induced peripheral neuropathy that have persisted for at least six months after chemotherapy ended. If cleared, Quell could offer a new non-drug option for patients experiencing CIPN, an important step for electroCore and those patients looking for symptom relief. Combined with continued progress in commercial execution and financial discipline, this new opportunity shows the path forward is stronger today than at any point in the last several years. Josh will take you through the quarter and where we are headed.
Mike will walk you through the plans implemented for growth and measures we track in the field, and Josh will then return with the financials.
Thank you, Tom. Good afternoon, everyone. This quarter, we delivered record net sales of $9.7 million, up approximately 12% from a year ago, and the lowest operating loss in our history, with adjusted EBITDA loss improving by nearly $1.4 million in the quarter, ahead of our expectations. Gross margin expanded to 88.5%, and loss from operation narrowed to $1.6 million. GAAP net loss improved by $1.3 million, or $0.13 per share, from $3.1 million, or $0.33 per share in the second quarter, and adjusted EBITDA loss improved to a company record $700,000. We grew revenue while spending less to do it. I will take you through the full financials later in the call. I want to be direct about where we are taking this company. We are not managing for short-term gains.
We are building long-term revenue that is durable, repeatable, and profitable. Every decision we made this year was made on purpose, knowing it could cost us near-term growth for longer-term success and profitability. Truvaga is the clearest example. Direct-to-consumer Truvaga revenue was down from a year ago, and that is exactly what we intended. The number of competitors bidding on Truvaga's own branded search term is up 60%, and our cost per click is up roughly 42%. We could have kept spending to grow the top line, but it would have been empty calorie revenue, padding the revenue line while pushing us further from profitability. We chose not to chase it, and our return on advertising spend improved 8% year- over- year. This represents how we think about driving revenue, not just driving the top line, but doing it with profitability in mind.
The improvement in our P&L is the early proof that this approach works. Net sales are up, operating expenses are down, and the company that grows while spending less is a company getting stronger. On guidance, we are revising our full year 2026 revenue outlook to $39 million-$42 million from our prior guidance of greater than 30% year-over-year growth. This is a change in timing, not direction. The sales organization changes we made are taking longer to reach the full field than we planned, so the acceleration we expected in the second half of 2026, we now expect in 2027. We made those changes because they are right for the business. That brings me to why we are confident in 2027. It comes down to three themes. First, coverage. More staffed VA accounts means more facilities where a representative is in the building selling both gammaCore and Quell.
Second, accountability. Smaller territories give every account a clear owner and a clear standard for results. Third, early proof that the model works. Mike will walk you through the leading indicators in the field, including how the representatives we have added since June are producing more revenue from their accounts than those accounts generated before they arrived. In addition, our chemotherapy-induced peripheral neuropathy, or CIPN, 510(k) is under FDA review. If we receive clearance in 2027, we could grow Quell revenue in two ways: by making sure reps are carrying Quell across our entire coverage area, and by opening a new indication for chemotherapy-induced peripheral neuropathy, where, to our knowledge, there is currently no medical device or pharmaceutical alternative specifically indicated for CIPN.
We believe these improvements will help us to deliver accelerated revenue growth in the full year 2027, with preliminary 2027 revenue growth guidance of 30%-40% year- over- year. We expect to refine this guidance range and provide additional commentary as appropriate in the future. Similar to what we discussed last quarter, and based on our current model, if we achieve that growth, we currently believe the operating leverage in our model, with gross margins in the upper 80s on a streamlined cost base, along with our existing cash on hand and financing resources, positions us to achieve our first fiscal quarter of positive adjusted EBITDA by the end of 2027 without entering into a new dilutive equity capital financing transaction. The next 12 months are about execution, and I would like Mike to show you how we are going to do that. Mike?
Thanks, Josh. Good afternoon, everyone. Josh described how we think about revenue acceleration. My job is to make sure our company and field organization is built to capture revenue and identify new opportunities available to expand. What got us here will not get us where we're going. So over the last several months, we have been developing stronger processes and setting higher expectations that result in better focus and metrics of how we source, hire, train, coach, lead, and measure results. I want to give you tangible metrics to show why we are so confident in the trajectory for 2027 and beyond. We track five imperatives every month: building leadership talent and sales efficiency, number of VA accounts using our products, new patient orders, or as we call NPOs, number of prescribers, and finally, our national refill rate.
I want to emphasize metrics that underpin three of these imperatives, which in turn support our conviction in accelerating revenue growth. First, leadership talent and sales efficiency. We split the Vice President of Sales role into two area Vice Presidents, one east and one west, who together oversee our six regions. We promoted a proven internal colleague from within our company to lead the east area. Our west area Vice President was recruited from outside the company and joined us in October. He has vast experience in leading medical sales organizations, including within the federal market, and expanding market share and revenue growth. We also added two new regional sales directors to our team in October, with a third soon to follow. That gives the field dedicated leadership, higher accountability, and greater opportunity for needed field coaching and expertise.
Where we have been able to make these changes, we've proven they work. In the third quarter, our southeast and northeast regions each delivered the highest quarterly revenue in their history. In the southeast, we transitioned territories to high-performing independent representatives focused on driving both Quell and gammaCore utilization, and the results followed quickly. The southeast is our blueprint. With new leadership in place, we can roll out that model nationally faster and more effectively. Our new independent representatives show why. Since June, the representatives we added have averaged approximately $210,000 a month in VA revenue in quarter three. That's a 30% increase versus the $160,000 a month those territories produced before, and the group is now trending toward $300,000 a month in October. Their September revenue was 62% higher than in June 2026. The early signals from these new representatives are what encourage me most.
Revenue and new account are growing quicker, taking roughly two months compared with six to seven months prior. By the third month, new patient starts have reached 3.4 per account compared to just 0.3 for those onboarded previously. These are early numbers, but they point in the direction we expected: faster starts, faster account growth, and deeper account penetration. Second, VA account penetration and impact. We opened seven VA accounts in Q3 alone that had never used our products, roughly a 5% increase over the second quarter, and the percentage of staffed facilities not carrying gammaCore decreased to 28% from 34% between June and September. Our revenue is becoming less concentrated. On the measure we gave you last quarter, our top 15 accounts went from 54% of revenue in the second quarter to 51% in the third quarter.
Going forward, we report on our top 30 accounts, roughly the top quarter of VA base, which went from 73% of VA revenue in the second quarter to 71% in the third quarter. In the third quarter, no single facility accounted for more than 10% of our VA net sales. In October 2026, Quell Fibromyalgia had its best month on record, and we passed 1,000 VA patients prescribed Quell in 2026 alone. This comes with more than 70% of the VA accounts that are not prescribing Quell at this time. For Quell, that shows the opportunity continues to be significant. Overall, NPOs for all products from the VA rose 21% in the third quarter year-over-year, which means more veterans receiving treatment, our ultimate measure and focus. Third, patient refills. Refills are one of the strongest signals of patient benefit.
Refill revenue grew 10% over the second quarter, the highest refill revenue in company history. Our national refill rate is 42% year to date through September, and our goal is to take it above 70%. The lever is patient training and prescriber confidence. We are piloting a new patient training initiative that focuses on higher levels of compliance, equating to better patient outcomes, and resulting in greater refill rates. Today, our goal is to take patient training compliance with therapy to a higher standard, which we believe is essential to reaching a 70% refill rate. The work is underway, and we expect refill rate improvements to begin to be recognized in Q4, with additional improvements to be expected in early 2027.
On operations, Lovell Government Services, which handles VA and Department of Defense sales generation, accounted for approximately 91% of our VA orders in September 2026, up from roughly 57% in June 2026, showing a significant movement in the number of orders processed through Lovell since announcing in August our intent to shift more of our sales through Lovell. Lovell is now the primary channel for all of our prescription product sales to the VA and Department of Defense. That aligns us with the best partner for federal distribution and is expected to reduce the related transaction fees associated with these direct sales by 3%. This also frees our internal resources to focus on new and emerging markets. In those new markets, we are building relationships across several commercial and federal channels where our products can benefit patients, and we report on them as they convert to revenue.
In Q3, Kaiser engaged in coverage discussions with us outside the California market. We have also engaged in a Quell evaluation in California and are encouraged by the results of their internal evaluation. For Department of Defense and TRICARE in Q3, much work was done to access key stakeholders and engage in conversations that are mutually beneficial to our active military and their families. We have identified pilot areas for federal workers' compensation, but we will hold on further discussions until additional process steps and validation is complete. We have engaged and initiated contracts for both VA Women's Health and First Responders Consultants. Both consulting groups have immense expertise and networks, and discussions have been initiated with key national opinion leaders who can drive progress and adoption of our devices. We are excited about both opportunities and will report metrics as they develop in Q4 and into 2027.
None of these measures tells the whole story, and we are still engaged in our transformation, but they are the measures we run the business on, and we will keep reporting against them so the investors can continue to track progress. As we extend these strategies across our national sales team, we expect stronger, sustained, and more profitable growth. With that, I will turn it back to Josh to walk through the financials.
Thank you, Mike. For the three months ended September 30, 2026, electroCore reported net sales of $9.7 million compared to $8.7 million during the same period in 2025, an increase of approximately 12% over the prior year. The increase of $1 million was primarily driven by growth in net sales of Quell Fibromyalgia products acquired from NeuroMetrix, Inc. in May 2025 and prescription gammaCore, which are both sold to the VA. During the remainder of 2026, the company intends to generate its sales in the VA channel through the company's agreement with Lovell. Gross profit increased by $1.1 million to $8.6 million compared to the third quarter of 2025. Gross margin increased to 88.5% from 86% in the prior year period and 86.5% in the second quarter, primarily due to favorable product mix.
Research and development expense was $400,000 in the third quarter of 2026, compared to $700,000 in the third quarter of 2025, and $800,000 in the second quarter of 2026. The decrease was primarily due to the timing of open positions, professional fees, and development costs. Selling, general, and administrative expense were $9.7 million, essentially unchanged from the prior year period and down from $10.1 million in the second quarter of 2026. Sales and marketing increased by $300,000 from the prior year, primarily driven by selling expense that supported the $1 million increase in net sales. General and administrative expense decreased $200,000, primarily due to lower professional fees. Total operating expenses in the three months ended September 30, 2026 were $10.1 million compared to $10.4 million in the three months ended September 30, 2025.
GAAP net loss in the third quarter of 2026 was $1.3 million compared to $3.4 million in the third quarter of 2025. GAAP net loss includes a gain in other income of approximately $400,000 related to the settlement of claims for indemnification and a $100,000 benefit from income taxes, which consisted of a favorable adjustment to our United Kingdom tax provision following a change in our transfer pricing policy. Net loss per share for the third quarter of 2026 was $0.13 compared to a net loss of $0.40 in the third quarter of 2025. Adjusted EBITDA net loss in the third quarter of 2026 was $700,000 compared to an adjusted EBITDA net loss of $2 million in the third quarter of 2025, an improvement of approximately $1.4 million or 67% year-over-year. Adjusted EBITDA net loss is a non-GAAP financial measure.
See use of non-GAAP financial measure in today's press release for additional information and a reconciliation to GAAP net loss. Total cash equivalents, and marketable securities at September 30, 2026 were approximately $7.5 million compared to approximately $10 million at June 30, 2026. Inventories increased to $4 million from $1.6 million at the year-end as we built supply to support forecasted growth in our prescription business. This action for near-term revenue growth acceleration, along with higher patient engagement through in-home delivery, accounted for a significant portion of the cash used in the quarter. Before we close, let me leave you with three points that matter most. This was a record quarter. Net sales of $9.7 million, up approximately 12%, gross margins of 88.5%, and our lowest ever loss from operations with adjusted EBITDA loss at its all-time low.
Revenue is up and expenses are down. We are building long-term sustained revenue, not chasing short-term gains. We are consciously moving towards revenue that moves us closer to profitability, and that improvement in profitability is occurring ahead of our expectations. We are revising full-year 2026 revenue guidance to between $39 million and $42 million, as we believe that some of the acceleration we expected in the second half of 2026 will come in 2027. More staffed VA accounts, smaller territories with clear accountability, newly added representatives already producing more from their accounts, all give us visibility and confidence in revenue growth that will accelerate the 30%-40% increase in 2027 revenue over 2026 revenue, with additional uptake in Quell if our CIPN 510(k) is cleared. Our liquidity and capital position are described in our Form 10-Q.
Our plan to reach our first quarter of positive adjusted EBITDA by the end of 2027 is built on a ramp in revenue and continued operating efficiencies. We are also evaluating options to refinance our existing term loan, including extending the timing of principal repayments, which we expect would provide additional support for our cash runway and balance sheet as we execute. We have not entered into any agreements, and there can be no assurance that we will. But taken together, and similar to what we said last quarter, if we are successful in executing these actions, our current model suggests that along with our existing cash on hand and financing resources. We currently believe that we can be positioned to reach our first quarter of positive adjusted EBITDA by the end of 2027 without the need to enter into a new dilutive equity capital financing transaction.
The plan is set, the team is in place, and the next 12 months are about execution. Thank you for your time and your continued support. We look forward to updating you next quarter. With that, I would like to open the call for questions. Operator?
Thank you, Joshua. We will now begin the question and answer session. If you would like to ask a question, please press star one on your telephone keypad. The confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. We will pause briefly to allow the queue to form.
I will stop there.
Thank you. Our first question is from Jeff Cohen with Ladenburg Thalmann. Please proceed with your question.
Hi. Thank you for taking our questions. This is Destiny on for Jeff. I have quite a few here, so I am going to try to condense them a bit. Can we start maybe, and Mike, this might be for you more so, but how are you thinking about the sales force in terms of maximum revenue contribution, right? So it went from the 160 number to 210. At what level do you think these reps would be kind of at capacity? Maybe I will start with that because I have a second part to it.
Thanks for the question, and it is a great question. As you know, accounts are variable in size, number of vets, number of specialties. The word saturation is a very difficult thing to define in the VA because of the markets we are in, specifically with migraine and fibromyalgia, including some of the subspecialties like women's health. The way we are looking at this right now, I do not think we have to worry about the word saturation as much as we are taking care of the patients where they are at. Community care is a large component of federal business, which means the veterans are being treated outside the VA but have VA benefits to get our products through prosthetics.
At this moment, I think we do have some accounts that are large in comparison to other ones, but when we talk to providers in those accounts, there are still a lot of uncared-for patients that are spread across the VA space. I would say our goal is to have about 14 new patients per month per account total between both products. That would be a good goal. But I do not know about the word saturation. That really would depend on the market of that account. For example, Dallas versus like Iron Mountain, Michigan. They are totally different in space. But we have goals for every account and every territory, especially with the diversification of the number of providers. Hopefully that gives you somewhat of an answer, even though I know the word saturation is hard to define.
Yes. No, that's actually very helpful, and you answered my second question. It was going to be patient start target per month. I think, did I hear you correctly, it was 14, right?
Yeah, we're looking at-
Okay
About two patients per week for the migraine product, gammaCore, and about one and a half to two per week for fibromyalgia, just depending on the account. That is the expectation we're setting with the sales force. Of course, we'd love them to exceed that, but that's the goals we're setting.
Okay, perfect. Turning more to the CIPN potential here, how are you thinking about that from a commercial perspective? Will you be able to leverage the same sales force you have, or do you think you might need a group that's a little more specialized? I know it's early, but just generally speaking, what are you thinking about that?
Specifically with the chemotherapy-induced peripheral neuropathy, 510(k)?
Yes.
Is that what this is?
Yes.
Yeah, that is a great question, and we are under evaluation for that just at this point, just like you said. To deal with peripheral neuropathy in the VA is a very big market, but when you start seeing chemotherapy-induced, we are identifying there are some different targets, especially with oncology and different types of nurse practitioners tied to those therapies. So we are evaluating. I am confident we will be able to do a significant number of opportunity accounts with what sales force we have today, but there may be a need for us to have more specialized or more focused approach for the oncology focus to that product. To be determined.
Okay. All right.
as we get this closer to the launch.
Got it. No, that makes sense. Lastly for me, for your DTC channel, I am curious, I was encouraged to see that the ROAS had improved. How should we be thinking about that in terms of revenue contribution and growth, if any? If you could just talk to that a little bit more, that would be super helpful.
Hey, Destiny. It is Josh. Thanks so much for the question. The short answer is really we are staying consistent with what we had said earlier on in the year, which is that we are not going to chase unprofitable revenue. Our goal is really to change the way that we think about driving revenue so that we get closer and closer to that adjusted EBITDA positive towards the end of 2027. To that end, we believe that year-over-year, our Truvaga revenue will grow. We have said that we believe that we were going to do that. However, our goal is not to grow it at the same, call it triple digits that it grew 2025 over 2024. That growth will be slowed down dramatically because the profitability of each revenue dollar that we generate through that growth is going to be up.
In terms of the way you think about it, what I would say is, our expectation is that year-over-year, it will be up somewhat, but the profitability that we are seeing on the back end is really our focus. We are not going to just chase what we said in the script, which are empty calories, right? Empty calorie revenue. We are really going to focus on how do we get those every dollar contribution to have a higher contribution margin than they did in the past.
Okay, great. That is super helpful. I am going to jump back in queue. Thank you.
Thank you, Destiny.
Our next question is from RK with H.C. Wainwright. Please proceed with your question.
Thank you. This is RK from H.C. Wainwright. Good afternoon, Josh and Mike. My first question is on the guidance itself. You are guiding for $39 million-$42 million. That requires you to do somewhere either from 6% to almost 30% in terms of sequential growth, which we have not really seen in the last three or four quarters. What gives you confidence that the business is at a place where it can give that at least the low single digit, low double digit growth sequentially?
RK, I'll jump in first, then I'll let Mike go from there. Mike gave a lot of KPIs in today's remarks, but really what it comes down to is really two main things. I'd say number one, the number of VAs, or specifically the number of people that we've got calling on the VAs, we believe are going to be fully staffed beginning in this October. As Mike went through, we've changed the way that we organize our sales organization. We broke up the organization such that now we have two area Vice Presidents. We've got six regional sales directors.
I think the first and foremost, the most important thing is, during the third quarter, what we established is that we have to continuously find new people that are able to be more productive, and people that have established networks and relationships within the VA to help sell our products. I think that's the first thing. The second thing, which is really just a continuation on that thought, is the people that we have onboarded, and the newer individuals and resources that we have selling our product, are actually proving to be more productive than those people that we had here historically, and they're getting up to speed quicker than what we have seen beforehand. From our point of view, I think we're really enthusiastic about the level of talent that we've brought in over the course of the last couple of months.
Those individuals have proven an ability to sell products historically, but they really are proving an ability to sell our products as well. Their ability to get up and running quicker and generate sales faster is something that Mike went through in some KPIs before. Mike, is there anything you want to add to that?
Yeah. Thanks, Josh. Hey, RK. Yeah, there's so many things that give me confidence, but I think just like Josh said, from the personnel side, that adds the biggest weight. Also, just know that there are resources internally from a targeting and actionable dashboard and reports to help our representatives identify those patients that need refills. We have more updated and really stronger data that they can take action on to work with the providers to help them understand if patients are doing well with therapy, that their therapy needs to be refilled. Our refill rate is a big focus, and some of the numbers that we have put in the forecast is a combination of better strength for getting additional new patients started, but also getting a higher refill rate that aligns with the evidence of this product in our clinical data.
Those things combined with everything Josh talked about, that is why we are seeing those forecast numbers where they are at. Hope that answers your question, RK.
Yeah. Thank you for all that color. Then, just keeping up with the guidance question itself, going into the next year, are we considering any revenues from the CIPN indication in that growth trajectory that you are guiding for? Or is this all based on what work you have done so far with the sales team and the products and the indications that you currently have in the bag?
No, I see.
Josh, you want to take that one?
Yeah, I see that as being upside. Ultimately speaking, we filed the 510(k). The soonest that that 510(k) that we would hear back from the FDA is probably not going to be until, call it, the back half of the first quarter, which means that from a sales point of view, actual sales itself within the, call it, the fiscal 2027, really wouldn't start generating until the back half of the year. So, to us, the way we see it is it's gravy as it relates to CIPN revenue, but we do believe that it could, in theory, open up new call points for us, having the ability to start talking about it. Remember, our product for CIPN, for Quell specifically, has Breakthrough Device Designation already.
Given that we filed, given that we have the Breakthrough Device Designation that we received for CIPN, we see it as an opportunity to open up for sales of Quell, which is part of the 2027 forecast, but anything CIPN-specific would really be incremental to that.
Okay. On Quell itself, can you help us understand the sequential performance of Quell in terms of order cadence and any organizational transitions that you're currently doing? Also, Josh, I'm just trying to understand. I believe the Quell and the CIPN initially, it was requested for 510(k), then something got changed in between, and then again came back to 510(k). So can you kind of walk me through that historical back and forth with the FDA and how confident are we that the 510(k) is the right way to do this?
Yeah, sure. So I'll answer that question, and then I'll kick it over to Mike to answer just sort of like the cadence of Quell revenue and where we're seeing that and where we see it going. So, just in terms of the 510(k) that was filed, you are correct. So, originally, prior to us acquiring the company, prior to us acquiring NeuroMetrix, conversations were being held by the former management there and the FDA about possibly putting in the submission. Without getting too much into the details, the advice that was essentially provided was to go down the De Novo pathway for CIPN. We, when we acquired the business, didn't necessarily think that to necessarily be accurate.
I mean, we also, not only does the product for Quell for fibromyalgia already exist, so the predicate was already there, we also had the Breakthrough Device Designation, which we thought as part and parcel of what the objective of having a Breakthrough Device Designation would be, which is to help streamline the ability of having new innovative products come to FDA to get approved. We thought that the 510(k) pathway probably, in our opinion, made a lot more sense. Fast-forward a few years, the members of the FDA that were responsible for reviewing what would be the CIPN filing is different. And the new team that was involved took a look when we started having conversations with them.
We actually filed the De Novo per their request, and the new team that was on board took a look at it and said, "We don't believe that this really should go down the De Novo pathway based on who we are and what our mandate is. We think that going down a 510(k) pathway is probably more appropriate given where you are and given the Breakthrough Device Designation." So, what they advised us to do was recall the De Novo, which we did, and then resubmit it as a 510(k), which we did, and we announced late last week. In terms of does it make us feel more confident or less confident, at the end of the day, we're still talking about the FDA. The data itself hasn't changed.
I do believe it's a good sign that the FDA review team has taken a look at the product and said, "Look, we don't think that there is a De Novo pathway here. We think that the safety that exists already through the predicate device being Quell is probably sufficient." So, that part of it is we're choosing to be optimistic, but it's still the FDA, right? Even though there's a Breakthrough Device Designation, even though the government and the FDA and this particular political party, although that's an interesting comment to make on November 4th, although that's changing in its own right, but current administration was really keen to try to push forward new innovative products. So, we're taking it as good news, but at the end of the day, it's still the FDA.
They will still go through their progress, and we're still dealing with a government agency on it. So, I guess we always plan for the worst, hope for the best, but we are hopeful that the information that we provided and the team that is reviewing it does see the benefits and the data that shows the potential benefits to the sufferers of CIPN, primarily because there are no medical device or pharmaceutical products that are cleared specifically or approved specifically for CIPN. So it would be the first, which would be great. In terms of the cadence of the business, I'll just leave with this tidbit before I hand it over to Mike, which is in the month of October, we surpassed 1,000 Quell patients, users, which is amazing. And I think the month of October was our largest Quell month in company history.
With that good news, I will hand it over to Mike. I will let Mike elaborate a little bit.
RK, just to help understand when you say cadence, could you give me a little bit more? What would you like to hear more about, is what I would like to know.
I was just thinking about how the orders are progressively. How are they doing in terms of the growth of the orders, and where should we think about this product going from currently $1.2 million or so per quarter? How high could it get to, not including the CIPN? Obviously, the CIPN could be another additional market. I do not know what you are thinking of that market itself, the CIPN.
Well, let us just talk about Quell Fibromyalgia as a standalone first, because that is what we are able to do now. CIPN in itself is a very exciting opportunity for the patients that we are going to be able to help, but also because of the unmet need. Currently, just to give you a little flavor of numbers, like Josh said, we had a very strong October. Dollar revenue and new patient orders in October were higher than January and February combined this year. We are seeing growth. Are we at a growth rate that we are happy with? I do not think we are ever happy, but we are satisfied that we are seeing the trends go in the direction it should be going.
We have a lot of work to do in a lot of VAs. It aligns with our strategies for other things going on within the company.
But from a cadence standpoint, the uptake of Quell within the federal space has been very positive, but we definitely need to continue to identify other ways that we can access more of these VAs, because currently, right now, we have too many VAs that have not touched Quell yet, and those are the areas that we're placing more emphasis with new representatives or enhanced coaching so we can have a better diversity of accounts here by the end of the year. But yeah, so far, it's in the right direction, RK. I think the nice thing to always remember is this product was from a company that was a standalone company, and I truly believe with the market of fibromyalgia and what this product can provide, it could be a standalone product for a company.
We're lucky to have it as a second product or even a first of two products, however you want to rank gammaCore and Quell. It's a very impressive technology, and I'm excited to see where this thing can go.
Great. Thank you. Thanks for taking all my questions.
Thanks, RK.
Thank you. Our next question is from Jeremy Pearlman with Maxim Group. Please proceed with your question.
Thank you for taking my question. First, I wanted to talk a little bit on the guide. It seems like on the last earnings release on the call, you had guided towards adjusted EBITDA 2027 in the third quarter, and this release, it seems like it is now by the end of 2027, and you are just guiding to 30%-40% revenue growth and on lower OpEx. So maybe what are some of the underlying assumptions of why it seems like that profitability has shifted a little bit?
Yeah, it is a great question, Jeremy. Thanks for joining. It is really just a function of timing. Some of the revenues that we were hoping to see within 2026, we see it now coming and accelerating in 2027. So, it is a function of basically shifting the time.
Okay. Understood. And then just, I know you mentioned some of the improvements from the sales reps in this quarter. Those improvements, is that more reflective of the productivity of the actual sales reps or maybe just also underlying maturation of the existing accounts, a combination of some? Maybe just if you could parse that out a little bit.
Yeah, I could say you are exactly right. I would say yes to all of it. We do have some very strong reps that have been here for a long time. Helping to have them grow and expand the number of providers in their existing accounts has been a big focus. Some of them had only been selling gammaCore, and now we have them selling both Quell and gammaCore. We also have replaced some account coverage with new 1099s, new regional sales directors with relationships, better access, and better expertise within the VA. I would say it is a combination of everything. We are assessing every single account and every single person that sells our products on a monthly basis.
There is a lot of different spots to be taken care of, but we are welding everything as tight as we can when we find where the weak spots are and sharpening more than we need to be sharper.
Got it. Understood. Maybe just also a little bit on the same point. There must be some sort of attrition rate from the actual patients who are using the gammaCore. What can you do to maybe stem some of that and keep the patients subscribing longer?
It is a great question. The biggest thing for what we found in medical device, especially within at-home devices where the patients are using it themselves, is the consistent opportunity for us to, what we say, show them the mirror so they can understand. Sometimes they forget that they were having 12 to 15 migraines a month, and now they only have six to eight. Just to verify the quality of life and the benefits they are seeing and some of the secondary effects of our therapies as well that they may not be recognizing. Also, just to make sure that the providers continually become advocates and make sure that they understand the value of continuing these products. In the VA, for example, a lot of triptans and migraine medications are used, what they call rescue meds.
There's a lot of physicians that understand the value of reducing medications in these patients, especially that are on things that are outside of label, within the antidepressant class or anxiolytics and things, just to continue to control migraines on top of their triptans. The less medications they use, the better for everyone. As we continue to work on higher compliance rates and higher refill utilization, the ultimate goal is to help the patients become healthier and happier and a more fulfilled life, as we owe our service members for all they've done for us. That's the plan.
Understood. Okay, thanks. Just last question related to the 510(k) submission. Just how large is the addressable market should that get approved? How many patients? Are you going to be selling, is that going to be within the VA, or is it going to be separate outside of that?
So, look, the answer is hopefully both, right? That's ideally. Again, as I said earlier, there is no other approved product, whether pharmaceutical or medical device, that is on market right now for CIPN specifically. So, we think that it's a great opportunity for us to enter into what's known as a blue ocean, or a market that doesn't have an opportunity. In terms of the overall opportunity itself, just to give you very high-level numbers, roughly 50% of the people that go through chemotherapy have some form of a neurotoxin, and roughly 50% of those people end up with some form of CIPN. So, the total addressable market, I think, in the United States would be roughly 600,000 to 700,000. Within the VA, it would be roughly 15,000 to 20,000. But they're large markets, but more importantly, they're large markets with no other alternative.
Being able to leverage the science, the technology, the safety profile of what we can offer based off of our bioelectronic technologies, we don't want to commit to not entering a larger market. But right now, as you and all of our investors know, the VA is primarily where we sell. That is probably going to be, if you will, the lowest hanging fruit as a way for us to start.
Okay. I understand. Thank you for all that information.
As we talk. I was just going to say, you said the addressable markets. We are going to address the market. We are not just going to stop at the federal space, but as you know, outside the VA, it takes a little longer because you start looking at reimbursement coverage and things. But with this type of opportunity, we are definitely going to investigate outside federal space. That is just want to add to that. We are going to go different directions with that. How that works and where that reimbursement comes, we will keep you posted.
Okay, great. Thanks for all that information. I will hop back into queue.
Great. Thank you, Jeremy.
Thank you. Our next question is from Fozia Ahmed with Brookline Capital Markets. Please proceed with your question.
Hi. Thank you for taking my question. My first question is regarding CIPN program. When do you anticipate an additional information request from the FDA? I know two studies were used to support the data for the CIPN. Are there any additional studies which are ongoing or anticipated to support this submission? Additionally, do you see that open 483 form to have any effects on the timings of the application that was submitted for CIPN?
Thanks, Fozia, for the questions. Regarding the timeline, typically, the FDA say that for a 510(k) submission, what they do is they look to get back to you within 90 days to give you an answer. After 90, what they call review days, and what review days mean is, they take the application, they usually take about two to three weeks to review the application to make sure it's complete. If it's in its complete form, then it goes to final review. From a final review point of view, they, meaning the FDA, have the ability to go back and forth and ask questions. Every time the FDA asks a question about the data, what will happen is, the clock stops, and then when you answer the question, whether the company answers the question, the clock remains.
The target date, usually for the FDA, is 90 review days. That's really just their target. In our, we think in a best-case scenario, again, best-case scenario, the first we'll hear from them about it will be the second half of the first quarter. In terms of the data itself, there are no plans currently in place for us to do additional trials for the application.
Thank you. And the effect of the open Form 483, do you think that can delay the timeline?
No, I don't think so. Good question. The 483 was very much specific to the over-the-counter NeuroMetrix product that was sold back in 2017. So, we do not believe that that could delay it. But again, it's the FDA, and it's completely their prerogative to ask as many questions about the safety and efficacy as they so choose.
Perfect. Thank you so much. I appreciate it.
My pleasure. Anytime, Fozia.
Thank you. Our next question is from Dr. Charles Theofilos, Private Investor. Please proceed with your question.
Josh and Mike, I want to congratulate you on leading this company in a new direction and bringing in a dynamic sales force. Bold, and I think it is going to work out extremely well. I was personally involved with the Quell acquisition for electroCore, and when it was acquired, they had a significant over-the-counter market with Quell, at one point reaching $15 million a year. Does electroCore want to revisit going over the counter with Quell?
Hey, Dr. Theofilos. First of all, thank you very much for joining. Always, your support of the company has really been unmatched, so we really appreciate you and all that you have done. For those of you on the call who may not know, Dr. Theofilos is more than just an investor. He is also a founder of the technology. So, we greatly appreciate you and the support you have given to the company.
Thank you.
In terms of your question, we believe that there is a market that could exist for an over-the-counter type of product for Quell. We call it Quell 2.0 or Quell over the counter when we talk about it in terms of our filings. We originally had stated that our intent was for us to launch that this year, but given the 483 letter that Fozia had just mentioned earlier, that has been delayed. Because the over-the-counter, the 483 commentary was really around the way that we think about the over-the-counter product, that product itself has been delayed. We would like, I should say, for us to go ahead and to launch some form of an over-the-counter-based product using Quell.
But the timing for that right now is to be determined, pending not just some of the 483 commentary, but also really going back to what we said earlier, which is our goal, first and foremost, is to chase profitable revenue. And we need to make sure that the market exists in a way that we can make those sales, but do it in a way that is profitable and brings us closer and closer to that adjusted EBITDA profitability towards the end of next year. And that will be sort of our guiding star.
Beautiful. Thank you very much, and thank you for your hard work.
Thank you. Thank you, Dr. Theofilos. Always nice to hear your voice.
Thank you. Our next question is from Walter Schenker with MAZ Partners. Please proceed with your question.
Thank you. The company recently released a clinical study done in the Air Force showing the benefits in healthy participants for physical and mental performance. Again, you have published a number of those. Just want to bring us up, and I know Mike has had a lot of other stuff on his plate, but sort of how he looks at the opportunities away from headaches and fibromyalgia into TAC-STIM or other police forces, government, sports, all the other opportunities where enhanced performance is probably a good thing.
Yeah, I could not agree more. I think that is one of the main reasons I came to this company, is when I saw the research of what has been published on the prescription devices, but then also the work that Dr. Staats and many others have done just on technology specific to vagus nerve stimulation. You hit a big topic there with the Air Force Research Laboratory. No question that data was extremely exciting to see. Just to let you know that obviously that data is transferable to other high-stress types of roles. Air traffic controllers is also another opportunity that have been in discussions.
A lot of the first responders that we have been focused on here since the end of Q2 to really start identifying places where this could be a benefit just beyond the active military, but other people that are living in a very high parasympathetic, sympathetic response type of role where they have a lot of trauma and they have a lot of stress. The answer is yes, it is a lot of transferable information. We just have to get the message to those, and that is one of the consultants that we brought in Q3 that is very aligned with a lot of the New Jersey area police, SWAT, and Port Authority to see if we can continue to work with them on their needs, and then also work with some of the other opportunities within the military and those that are in similar stressful situations. Yes.
Hopefully that answers your question, but yeah, I agree. That is not the type of information you want to just leave on the shelf. A lot of other people need to see that.
Okay, thank you.
Thank you. We have now concluded the live Q&A portion of the call. I will turn the call over to Joshua for closing remarks.
Thank you, operator. We really appreciate it. Before we close, I want to take a step back from our quarterly results for a minute. We have a platform with real science behind it and a first to market that we have barely begun to penetrate. Where we have made our commercial changes, they are working, and now we have the leadership in place to take them national. We do not just believe the growth is coming, we see what we believe to be the early indicators within the numbers. For us, the timing has moved, but our conviction has not, and it is now our job to turn those early indicators into sustained results. I want to just take the opportunity to thank our shareholders for your patience and your continued support. Of course, to our patients, our providers, and our partners, thank you for trusting us with your care.
And most importantly, to our team, thank you for showing up every day with the discipline and the ambition that this opportunity demands. We appreciate everyone's participation in today's call, and we look forward to speaking with you again next quarter.