electroCore, Inc. ($ECOR)

Earnings Call Transcript · May 6, 2026

NasdaqCM US Health Care Health Care Equipment and Supplies Earnings Calls 51 min

Earnings Call Speaker Segments

Operator

Operator
#1

Greetings, and welcome to the ElectroCore First Quarter 2026 Earnings Conference Call. [Operator Instructions]. As a reminder, this conference is being recorded. Earlier today, ElectroCore published results for the first quarter ended March 31, 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 second 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. ElectroCore disclaims any obligation to update these statements, except as required by law. This call contains time-sensitive information accurate only as of today, May 6, 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, Interim President and Chief Financial Officer; and Mike Fox, recently appointed 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?

Joseph Errico

Executives
#2

Thank you, Amanda. Good afternoon, everyone, and thank you for joining ElectroCore's First Quarter 2026 Earnings Call. This is the first earnings call since we announced our leadership transition, and I want to take a moment to share how encouraged I am by the progress we have made executing that transition and by the momentum we continue to see across the organization. Since stepping into the role of Interim President, Josh has provided steady, disciplined leadership while maintaining his focus on financial rigor. The alignment between our operational priorities and our financial strategy has been evident, and the organization has responded with focus and urgency. The strategy has not changed. The execution has not slowed. If anything, the focus across the organization has sharpened. At the same time, Michael Fox joined us as Chief Operating Officer on April 13, bringing more than 35 years of commercial leadership experience across complex health care markets, including extensive work within the federal systems and the U.S. Department of Veterans Affairs. In just 3 weeks, his depth of experience has already provided valuable insights to strengthen our execution, particularly as we continue to expand our presence within complex government channels. He will introduce himself shortly. Importantly, this transition has not slowed us down. It has reinforced our foundations. We remain firmly committed to our strategy, driving growth within our covered entities, advancing our clinical and scientific leadership in noninvasive vagus nerve stimulation, and expanding our reach into the consumer wellness market. And we are doing so with discipline, managing the cost base, expanding the margin, and protecting our path to profitability. In our clinical work, we continue to invest in the evidence base that underpins our portfolio. That evidence remains a key differentiator as we engage with providers, payers, and partners globally as well as domestically, and it positions us to expand into new indications over time. In the VA, where we have built a credible commercial presence over many years, we believe we have a meaningful long-term opportunity. Our commercial leadership is leveraging Mike's experience to identify new ways to be more targeted and more effective, particularly within a system where we still have substantial room to penetrate. On the consumer side, we are building a scalable direct-to-consumer channel with increasing brand visibility, improving unit economics, and a growing network of influencer and affiliate partners that resonate with audiences seeking non-pharmacologic, science-backed wellness solutions. The early traction we are seeing reinforces our belief in the broader applicability of our technology and its relevance to everyday wellness. What gives me the greatest confidence is not just the program itself, but how it is being achieved with discipline, alignment, and a clear sense of purpose across the organization. We are building a strong foundation, and we are doing so in a way that positions the company for durable long-term growth. While our search for a permanent CEO continues, I am confident that the team we have in place today, Josh, Mike, and the broader leadership group, is the right team to execute against our priorities and carry our strategy forward. I look forward to updating you on our continued progress in the quarters ahead. With that, I would like to introduce our new Chief Operating Officer, Mike Fox. Mike?

Unknown Executive

Executives
#3

Thank you, Tom. Good afternoon, everyone. I joined ElectroCore for one reason. I saw a science-based platform technology with proven published clinical outcomes data that support a credible commercial foundation and significant room for growth, particularly within the federal channels where I spent most of my career. Three weeks in, that conviction has only strengthened due to my greater exposure to the existing and future data sets being gathered. I also had the opportunity to meet a vast number of talented colleagues within the company who are dedicated to the mission and the patients we serve. So, rather than walk through my background, let me tell you what I've been focused on and where the opportunity exists. A major priority is the VA and Department of Defense markets. We have just scratched the surface of penetrating the addressable VA headache market. So we have patients being treated with our products in VA medical centers across the country, but we're not attaining the utilization level that meets the needs of our veterans and the dedicated providers caring for these military heroes. The majority of new patients identified and prescribed our products in Q1 are not spread across the country as expected or needed. That tells me 2 things. One, we have built real distribution; and two, we are nowhere near saturation. My focus is moving from facility breadth to facility depth, more prescribers per site, more patients per prescriber, and a more consistent customer experience across the system. My second priority is the broader federal channel. The VA is our largest entry point, but it is not the only one. The Department of Defense across all service branches represents an underdeveloped opportunity for both our prescription products and for TAC-STIM. Given the heightened tempo of U.S. military operations abroad, the demand environment for noninvasive, drug-free performance-supporting solutions has only intensified. I spent the last 3.5 decades building relationships in these channels, and I intend to put them to work for this company. My third priority is operating discipline. Josh and the team have built a high-margin business, 87% gross margin in Q1, and you're starting to see operating leverage show up in the numbers. My job is to make sure that as we scale, incremental revenue translates to incremental bottom line, not incremental costs. We intend to grow this business efficiently while we establish ElectroCore as a partner of choice to ensure market stability in the years ahead. I'm 3 weeks in, but trust that my experience in developing company growth and success is from decades of learning and proven execution strategies. I'm truly excited about the opportunity presented to me here at electroCore. There will be much more for me to share over the coming quarters, but I'm convinced that what is in front of us is real, and I'm truly grateful to be a part of it. With that, I will turn the call back over to Josh to walk through the quarter. Josh?

Joshua Lev

Executives
#4

Thank you, Mike. Before I get into the details, let me tell you what this quarter represents for electroCore. We just delivered our highest revenue quarter ever, $9.6 million, up 43% year-over-year. Gross margin expanded to 87%. GAAP net loss was $5.3 million, and adjusted EBITDA loss improved by 24% to $2.3 million. That combination, accelerating top line, expanding margin, and improving adjusted EBITDA loss in the same quarter, is demonstrating operating leverage, and it is the clearest signal yet that we are executing on our strategy. We are reaffirming our full-year 2026 revenue guidance of approximately 30% growth. As I'll discuss in a moment, the catalysts in front of us for 2026 give us conviction in that outlook. Now to the details. The VA hospital system remains our largest customer, and growth there continues to accelerate. Prescription device revenue increased 48% year-over-year to $7.9 million. Within that, prescription gammaCore grew 26%, and Quell sales surpassed their first $1 million quarter. Since we acquired the Quell assets from NeuroMetrix in May 2025, Quell fibromyalgia has generated $2.5 million in cumulative revenue, and we are still in the early stages of placing that product across the VA system. As of March 31, approximately 15,000 VA patients have received the gammaCore device, which we estimate represents roughly 2.5% penetration of the addressable VA headache market. The underlying patient population continues to expand. A 2024 study published in JAMA Network Open of nearly 500,000 U.S. veterans found that 8.2% of male and 30.1% of female veterans report a history of migraine, roughly 3x the rate observed in the civilian population, and that approximately half of veterans with migraine also meet criteria for PTSD. The U.S. Department of Defense has reported more than 485,000 service members' traumatic brain injury diagnoses since 2000. Combining with the Veterans Health Administration's emphasis on non-opioid first-line treatment for chronic pain, we believe the runway for prescription gammaCore adoption inside the VA is long, and we are still early. Turning to our consumer wellness channel. Revenue reached $1.6 million in the quarter, up 44% year-over-year, with Truvaga contributing $1.5 million, up 38% from Q1 of last year. This quarter, we deliberately tempered top-line growth in favor of efficiency, and the results are showing up in the unit economics. Our return on advertising spend, or ROAS, was approximately 2.37 in the period, a 14% improvement over the prior quarter. In plain English, every dollar we spent on Truvaga-related media generated nearly $2.37 of revenue. That improvement was driven by a concentrated shift toward affiliate and influencer partnerships that reach consumers already interested in wellness and in vagus nerve stimulation specifically. Return rates remain in the 12% to 15% range, consistent with prior periods. We believe the macro environment for our consumer wellness offering is meaningful. The Centers for Disease Control reports that approximately 24.3% of U.S. adults experienced chronic pain in 2023, up from 20.4% in 2019. Independent industry research projects the global noninvasive vagus nerve stimulation segment will expand at a low double-digit CAGR through 2030, supported by aging demographics, the regulatory and clinical pivot towards non-opioid pain management, and rising consumer awareness of the vagus nerve. We believe Truvaga is well-positioned to capture a meaningful share of that growth. On to TAC-STIM, our human performance product. While quarterly TAC-STIM revenue has historically been variable, the underlying demand environment for cognitive performance and fatigue mitigation in the active duty military and federal channels is robust and getting more robust. Given the heightened tempo of U.S. military operations abroad, particularly around remotely piloted aircraft, drone defense, and other extended duration mission profiles, the need for noninvasive, drug-free solutions to support war fighter alertness, focus, and resilience has only grown. TAC-STIM is the subject of ongoing research and evaluation across the U.S. Air Force Special Operations Command, the U.S. Army Special Operations Command, and the Air Force Research Laboratory, and was previously selected by AFRL for inclusion in the real-time assessing and augmenting cognitive performance in extreme environments program, a program designed in part to support multi-day transoceanic operations and long-duration remotely piloted aircraft missions. With Mike now leading our commercial operation, we see a meaningful opportunity in 2026 and beyond to deepen our engagement and to pull TAC-STIM through as a more consistent revenue contributor. Now to the financials. Net sales of $9.6 million represented 43% growth over the prior year, driven by gammaCore and Quell within the VA and continued growth in Truvaga. Gross profit was $8.4 million with gross margin expanding to 87%, a 200 basis point improvement year-over-year. Research and development expense was $740,000, up modestly from the prior year, primarily reflecting work on the ACACIA PTSD study. Selling, general, and administrative expenses were $12.9 million. That number includes approximately $1.9 million of nonrecurring leadership transition costs and $300,000 of legal expense related to the ongoing IP litigation. Excluding those items, the year-over-year increase was driven by approximately $1.6 million of variable expense, supporting our $2.9 million revenue increase, a clean illustration of how the cost base scales with the top line. Other expense of $276,000 includes interest associated with the convertible term debt financing we put in place with Avenue Venture Opportunities Fund. GAAP net loss in the first quarter was $5.3 million compared to $3.9 million in the prior year period. This increase was driven primarily by the $1.9 million in nonrecurring leadership transition costs. Net loss per share was $0.59 compared to $0.47 per share in the same period last year. Excluding the leadership transition expenses, net loss per share was $0.37. And now I want to draw your attention to the 24% improvement in our adjusted EBITDA loss, which I believe is an important indicator of the operating leverage we are building. Adjusted EBITDA loss for Q1 was $2.3 million compared to $3.1 million a year ago. That improvement happened in a quarter where we absorbed $1.9 million of nonrecurring leadership transition expenses. Strip those out, and the operating leverage in this business is even more evident. Revenue grew 43%, and adjusted EBITDA loss narrowed 24%. As we scale further, that gap is what gets us to profitability. A reconciliation of GAAP net loss to non-GAAP adjusted EBITDA net loss is provided in the financial tables in today's press release. Turning to the balance sheet. Cash, cash equivalents, and marketable securities were approximately $8.8 million at March 31, 2026, compared to $11.6 million at December 31, 2025. One important note on cash. Q1 is historically our highest cash burn quarter of the year. This year, certain working capital items, primarily the timing of inventory and capital improvements to our Rockaway facility, may extend a portion of that burn into the second quarter. We are managing the balance sheet with discipline and remain focused on the operating efficiencies that support our path to profitability while also evaluating available capital resources, including our existing shelf registration statement and at-the-market facility. Before we open the call for questions, I want to spend a minute on the catalysts ahead of us in 2026 because the runway from here is significant. First, R&D and nVNS as a platform technology. We continue to work towards a platform of products that can be sold through our established sales channels. This comes in the form of indications, products, and features. The body of evidence supporting the therapeutic potential of nVNS continues to expand. A new publication in Frontiers in Neuroscience entitled ‘Adjunctive non-invasive vagus nerve stimulation for chronic mild traumatic brain injury with comorbid post-traumatic stress disorder, a post-hoc analysis highlighted findings on the potential benefits of adjunctive noninvasive vagus nerve stimulation in patients with mild traumatic brain injury and PTSD. Additionally, approximately 20 participants have enrolled in the clinical study conducted by Acacia Clinics in collaboration with the Vagus Nerve Society, designed to evaluate the safety and effectiveness of electroCore's gammaCore nVNS device as an adjunctive treatment for symptoms associated with PTSD. PTSD is a breakthrough device designation for us. And as the data matures, we expect it to become an increasingly important part of the platform story. Work on our next-generation Truvaga and Quell mobile platform is underway. We are developing a mobile application designed to complement our consumer products, deliver more personalized features and user experiences, and, if done right, open the doors to recurring revenue, deeper engagement, and richer real-world data. Second, we remain focused on opening additional commercial channels for our products. Beyond continued VA penetration, Mike's mandate includes expanding our commercial and federal channel presence. This includes areas such as Kaiser, federal workers' compensation programs, TRICARE, and broader adoption within active duty military and the Department of Defense. With TAC-STIM already engaged across Air Force Special Operations Command, Army Special Operations Command, and the Air Force Research Laboratory, we see meaningful opportunity for additional federal contract activity. Quell continues gaining adoption through our current sales channel and primarily within the VA. Sales of the Quell product line surpassed $1 million in quarterly revenue for the first time in Q1 2026, bringing cumulative Quell revenue to approximately $2.7 million since the acquisition from NeuroMetrix in May 2025, including $2.5 million of Quell fibromyalgia sales in the VA. We have a small cohort of legacy Quell over-the-counter users and expect to relaunch the over-the-counter Quell relief for lower extremity pain later this year. Earlier this year, in January 2026, we launched Truvaga in the United Kingdom. And as that business scales, we expect to evaluate additional markets. Third, perhaps the most important catalyst of all, is our path to profitability. The math is straightforward: mid-80s gross margin, accelerating top line, increasingly disciplined cost base. We are not yet ready to provide a specific quarter for breakeven, but that trajectory is clear, and Q1 is the strongest evidence yet that we are on. Taken together, these catalysts underpin our reaffirmed full-year 2026 revenue guidance of approximately 30% growth, which translates to roughly $9 million to $10 million of incremental revenue versus our $32 million in 2025. We expect the majority of that growth to come from continued VA prescription growth, where Q1 alone delivered prescription device revenue of 48% year-over-year. Truvaga growing in the high 30% range and improving in efficiency is our next meaningful contributor. Quell Relief and our international launch represent newer contributions that we hope to scale through the back half of the year. TAC-STIM, while historically variable, represents potential upside as Mike deepens our federal engagement. And our next-generation mobile platform is a 2027 contributor that opens the doors to recurring revenue over time. In short, 3 catalysts, a clear 30% growth bridge from 2026 and a longer runway into 2027 and beyond. With that, I would like to open the call for questions. Operator?

Operator

Operator
#5

[Operator Instructions] Our first question comes from Jeff Cohen at Ladenburg.

Destiny Buch

Analysts
#6

This is Destiny on for Jeff. I just wanted to touch on the VA channel a little bit, and this is going to be a multipart question. But I'm wondering, as you move away from breadth and more towards depth in this channel, does that change the structure of your sales force in terms of W-2 versus 1099? And then how are you balancing expanding into new sites versus additional patient treatment or additional patients treated, I should say?

Joshua Lev

Executives
#7

Hi Destiny, thanks so much for the question. Really appreciate it, and I appreciate you being on the call today. I think the best person to answer that question will be Mike. Mike, why don't you jump in and let everyone know what your strategy is?

Unknown Executive

Executives
#8

Yes. Thanks, Josh. I think the question is a really good one because I don't believe it's an either/or in my experience, we definitely want to expand breadth. We do have VA utilization across the country, but the depth in various specialties and within various patient segment groups is not where it needs to be. I'm a fan of the 1099 model. I'm a fan of the W-2 model. In my history, as long as we have strong performers that are aligned with the strong mission to help our veterans, we can build a really strong opportunity around that. So, I don't see this being a big change as much as just an internal alignment focus and opportunity for us to ensure that we're setting appropriate expectations and really hold people accountable to exceeding those expectations for both our gammaCore line and the Q. Destiny, does that answer your question?

Destiny Buch

Analysts
#9

It does. I think I would also just be curious what your target is for the number of clinics for the end of 2026, perhaps a range from that 200 number?

Unknown Executive

Executives
#10

That depends on right now when we say clinics. I really like. Clinic centers. Yes, the VA medical centers depend on what number you want to utilize. I've always been in the belief that we're not helping at least 75% of the facilities across the country help the vets. We're not doing our job. I don't know about an exact number, but we need to get really active and have consistent utilization of our products and treat veterans in at least 75% of those accounts on a monthly basis.

Destiny Buch

Analysts
#11

And then, as you go into these other DoD channels, how does that process compare to the VA centers? Is it similar in terms of timing?

Unknown Executive

Executives
#12

It probably will be a different story altogether because, as you know, they're both under FSS, but the Department of Defense accounts, like the military health centers, also include the TRICARE component. So there are different segments. But from a timeline perspective, the VA usually takes a long time to get things established due to FSS and working with our customers, like global government services for some things. On the Department of Defense side, I would expect by sometime Q3 or Q4, with our plan in place, that we'll start seeing additional revenue.

Destiny Buch

Analysts
#13

And then I guess transitioning over to wellness and Truvaga, you have really strong ROAs this quarter, which I think is fantastic. I'm just wondering if there were any changes to the marketing channels that played into that stronger ROAS.

Unknown Executive

Executives
#14

Yes. I'd say that's a great question. It's not so much a change in the marketing channels. It's more a function of where we are deploying and investing our resources. We made a more concerted effort to work on affiliate programs and influencers. You may have seen that Miranda Kerr posted about us earlier. That's a co-marketing opportunity that we have. Those are opportunities where what we could do is utilize and leverage the marketing budgets of other people so that they're actually the ones that are putting out there the marketing messaging. And really, what we're doing is using that halo effect to help lift our efficiency. So it's not so much a change per se. I wouldn't say that we cut out any of the other channels or media that we've done before. We're just reallocating the resources and looking at it slightly differently.

Destiny Buch

Analysts
#15

And have you noticed any differences in repeat purchase behavior or anything of that nature compared to last year?

Unknown Executive

Executives
#16

Not yet, but we also haven't given any formal guidance on that either. But I would say not yet for the time being. Everything seems to be business as usual.

Operator

Operator
#17

Our next question comes from Fozia Ahmed from Brookline.

Fozia Ahmed

Analysts
#18

First, Mike, thank you for joining the call and coming on board. We look forward to engaging with you. My question is on the FRONTIER study on PTSD patients, which was very compelling. I was wondering if you could just remind us how this study is aligned with the ongoing ACACIA trial. Is it set up the same, whether the outcomes are actually designed to capture the same outcomes that were published in FRONTIER or something different?

Unknown Executive

Executives
#19

It's something slightly different. Both of them are there to capture patients with PTSD and the effects of utilizing noninvasive vagus nerve stimulation on patients with PTSD. The actual protocols themselves are slightly different. And you can look those up on the IRBs if you'd like. But in essence, the idea here is how to aggregate different data points that have PTSD as being tested in a patient population, but the populations themselves may be slightly different.

Fozia Ahmed

Analysts
#20

And then I have a follow-up question. There's a breakthrough designation attached to PTSD. Are there any ongoing discussions with the FDA at this point?

Unknown Executive

Executives
#21

So in previous quarters, we've given information and spoken about how we've gone back and forth with the FDA in terms of the best way to approach expanding the breakthrough designation to what would be a formal PTSD label. What we're doing with a lot of the work now, primarily with the ACACIA study and what you just referenced a moment ago, is really aggregating more data points and information that we can bring to the FDA to have a full rollout of what would be a PTSD indication and a full label. And we're doing that sort of in conjunction with them in that they've identified or articulated to us what they're looking for. And based on that information, we're looking to take that and aggregate the data set to provide to them to ultimately apply for the full form PTSD.

Operator

Operator
#22

Our next question comes from RK Ramakanth at H.C. Wainwright.

Swayampakula Ramakanth

Analysts
#23

Good afternoon, Joshua, and welcome aboard, Michael Fox. Hopefully, you guys are able to hear me. I have two or three questions. So Josh, just starting off, thanks for reiterating the 30% growth for 2026. But during the first quarter, there was a gain of 43%. So what is it that's keeping you from being more careful than needed? Do you see something that makes you -- I'm not going to use the word concern, but makes you think that I need to wait for at least one more quarter to change that guidance?

Joshua Lev

Executives
#24

That's a great question, RK, and very astute. The answer is no. More than anything, we have internal projections, as you know, and the guidance that we provided to the Street is really based on what we believe organic growth could look like based on, I would say, an outdated model, if you will. And what I mean by outdated is that Mike, with all of his experience of coming to the organization, has utilized strategy and tactics, which have helped grow its former businesses 3x to 4x in terms of top-line revenue. Mike's only been here since April 13th. So it's not really necessarily "fair" hard to expect any more sort of direction or tactics as it relates to how it's going to be able to expand or accelerate that growth, what the timing of that growth is going to look like and the resources required, which is the reason why we keep on going back to -- we are going to provide more detailed guidance when it becomes available and more appropriate. It just hasn't been enough time for Mike to get his feet wet fully to be able to map out and say, Okay, I think that we can grow by x, but it's going to take this amount of time.

Swayampakula Ramakanth

Analysts
#25

And Michael Fox, as I said, welcome aboard. I have a quick question for you. As you were doing your due diligence and trying to get on board, gammaCore has been marketed to the VA facilities for quite a while now. We have about 200 centers, actually not only acquiring but also stocking the product. From your experience and from what you have done in the past, what are the easy pickings in the VA market to move to a larger number of centers? And also outside of the VA, can you name one or two additional federal centers where you think this can be an easy sell?

Unknown Executive

Executives
#26

RK, that's a really good question. And I would say, from what I've seen in my experience in the VA, the best way to adjust within the VA is to work with them. The VA has a lot of standardizations. They've got a lot of requests for algorithms and treatment protocols, medical necessity. I find a lot of companies do a lot of great things, one account at a time, but they're not working with the leadership at the business level or national level to really place where this product fits and get support from top down. I believe this company has done a phenomenal job of generating support from the bottom up. What I can do is continue to work with that information, that data, the patient-provided outcomes, and the information gathered by our providers in the VA to generate more opportunities for us to standardize treatment and put a really strong position for gammaCore within the federal space. On the second part of your question, outside of the VA, I know there's a large federal workers' comp opportunity with the number of headaches and migraines within that space. Within the Department of Defense, whenever you say Department of Defense, you've got to think of places like Walter Reed, SAMMC, Portsmouth, Naval, and Balboa. There are so many medical facilities that treat patients post-deployment who come back with various things that we can definitely assist them with. So it's early in my evaluation of where we will be able to start, but I promise, for the Department of Defense, it will be with key opinion leaders within the headache space on those active military bases with a focus on the larger centers first, probably closer to the East Coast where we're based. Does that answer your question, RK?

Swayampakula Ramakanth

Analysts
#27

Yes, yes. So, if I can, one more question for you, Mike. In terms of Kaiser Permanente, this is one of those entities where you really need to generate internal KOLs that can drive the growth of the product. I'm not sure. In terms of your experience, do you see that as a real way to do it? Or are there any other levers that need to be pulled? Because I believe once you can get that going, it can be a good draw for the product.

Unknown Executive

Executives
#28

RK, that's a phenomenal question. And I think a lot of companies ask the same thing about Kaiser because everyone knows the importance of a place like that for business. I can't say all the details of our propositions to date with Kaiser. I have been on numerous calls. I'm very excited about what we have going on in the key opinion leader support within Kaiser. It is a phenomenally well-organized and standardized group. So within the foundation, I know there's a lot of support. So the work is definitely being done in the California market, and we're going to address some other outside-of-market opportunities. But I don't want to get too deep into the Kaiser description of what's going to happen, but we have a very favorable position now that we need to really just understand what's holding us back so we can generate that necessity from the customers. But you are right, we need internal providers requesting it. And I can tell you from my early meetings, we have national headache and migraine experts already doing that. So we're in a good spot. We've got to, I would say, tie a bow a little bit and figure out what's missing, but we're getting a lot of momentum there.

Swayampakula Ramakanth

Analysts
#29

On the Quell Fibromyalgia, you have $2.5 million cumulative in the VA market. How big is the opportunity within the VA for Quell? And is there any opportunity outside of the VA, because it looks like it was not sold much as an over-the-counter sort of product, because you have quite a bit of experience now with Truvaga? And I'm just trying to understand how that can be translated into Quell OTC, if I can call it that?

Unknown Executive

Executives
#30

Well, that's a great question, okay, because within the VA, obviously, we're treating some of the multidisciplinary types of patients with multifactorial disorders. And fibromyalgia as a percentage is a large population in the VA. I think there are some recent statistics just on even active military. It's very low before they go on deployment. But upon return from deployment, it's about 11% just on active duty. So the veterans as a whole are always exposed to greater and bigger issues. So it is a market by itself, which is very, very scalable as a product like Quell.  Outside of the VA, I think we all have family members and friends who have been dealing with fibromyalgia. It is a big opportunity outside there. But I would say we talked about Kaiser a little bit earlier. I think those are the markets that would be the first ones to address as we continue to explore, maybe some opportunities to talk with Triwest and Optum for some of the active military. That's the plan for at least the immediate future, but we still have to verify what the best spot is.

Joshua Lev

Executives
#31

And look, RK, it's also definitely worth noting as we look at the number of facilities that are out there prescribing our products, the fibromyalgia product as well is being prescribed in roughly 1/3 of the number of facilities that gammaCore-S is being prescribed. So if you think about that in the context of the overall runway, we acquired the company a year ago. We've been able to grow that to about $2.5 million within the VA system. But of that VA system, it's concentrated in one area of the region. We just need to spend more time being out there and selling. So there's a lot of opportunity, I think.

Swayampakula Ramakanth

Analysts
#32

So I don't mean to hog the call, but one last question on Truvaga. What learnings can you take from the U.S. to the U.K. part of it?

Joshua Lev

Executives
#33

That's a great question. Right now, we've only launched in the U.K. with our Truvaga 350. We've had a lot of inbound interest that is coming from the U.K., and people who are expressing the need or the desire to get more access to vagus nerve, noninvasive vagal nerve stimulation for the wellness space. So it's early days there. We really just launched it in January. It's a soft launch.  What I mean by that is we're not actively putting any media dollars behind it right now. Really, what we're trying to get a better understanding of is what the uptake for that Truvaga 350 unit is? And does it make sense, and what is the business opportunity more broadly, not just in the U.K., but also in other areas outside of the U.S., but also outside of the U.K., to go ahead and launch a next-generation product like the Truvaga?

Operator

Operator
#34

Okay. Josh, our next question comes from Jeremy Perlman from Maxim.  His first question is actually for Mike. He says, " Where does Mike see the easiest wins, the lowest hanging fruit? And what are his longer-term plans to drive increased utilization?

Unknown Executive

Executives
#35

Thanks for the question, Jeremy. In my vast 4 weeks of experience, the low-hanging fruit opportunity is, as we discussed, the federal space. I think the VA and the unmet needs of our veterans are a key focus for us. We know we have a really strong opportunity there and other federal channels, as we discussed, with the Department of Defense. I think long-term plans are a good starting spot, but we all know that it's a good place to help our veterans, but we have to go beyond. That's where I think the longer-term plan will continue to work on the commercial segments and figure that system out as a way for us to expand beyond the FSS and DSA opportunity. So that's still in development, still being identified, but that's the long-term plan, so we can develop the revenue for the long term.

Operator

Operator
#36

Jeremy's next question is what the Quell release commercialization rollout looks like in target markets and users.

Joshua Lev

Executives
#37

Yes. So great question. So first and foremost, Jeremy, there is a small cohort of users of the Quell over-the-counter product that we inherited when we acquired the NeuroMetrix business. You may recall that when NeuroMetrix was at its peak, it was doing somewhere in the tune of $12 million to $15 million of Quell over-the-counter related business. And a lot of that went away after the company decided to do a strategic pivot, had the FTC issue, and move to a medical device Quell fibromyalgia product. So from our point of view, what we're really focused on is making sure, number one, that we can still go ahead and service those legacy consumers that have been using the product or that may want to continue using the product, but it's no longer available. That's number one. And then number two is we need to do it in a way that makes sure that we have addressed all of the concerns that NeuroMetrix had addressed regarding the FTC. So, in terms of overall rollout and commercial strategy, the answer is going to be that it's going to be slow. and it's going to be well defined, but it's going to be deliberate in that we're purposely going to make sure that we've addressed the concerns that NeuroMetrix had earlier in their iteration as an over-the-counter product so that we can go ahead and do it in a way that's balanced between offering a Quell fibromyalgia FDA-cleared product or FDA-approved product and then also a consumer product as well.

Operator

Operator
#38

Okay. And our last question from Jeremy. What are your leading indicators, pipeline, reorder rates, and device utilization that give confidence in continued acceleration in guidance?

Joshua Lev

Executives
#39

So again, Jeremy, great question. I tried to really focus on it at the end of my remarks, but there's really, we look at this in terms of 3 main categories of catalysts. The first is R&D related, so that could be additional indications. PTSD is putting out additional information about how the studies are going. If you look and you follow our IR page, you'll note that we put out recent press releases, noting the ACACIA study, noting some other publications where data is coming out to help support what could be the makings of a PTSD label. That would be an R&D effort. Products or features that we had mentioned as it relates to Truvaga and Quell, we are investing in our second generation or our next-generation mobile application. Those features will allow us to hopefully get to a point where, if done correctly, we'll be in a situation where we can have a recurring revenue model. So that would be the first catalyst. The second catalyst will be commercial, being able to go ahead and announce items such as launching Truvaga outside the United States, as we recently did in January, the opportunity or the probability of ultimately launching the Quell Relief or the Quell over-the-counter product as its own stand-alone consumer product. Hopefully, Mike is coming to the table and being able to announce either further traction within places like Kaiser, new orders within the federal marketplace like federal workers' comp, perhaps TRICARE. So opening up different commercial avenues. Lastly, which is the third catalyst will ultimately be the operating results. We believe that we can be in a situation where these other catalysts will help drive increased total addressable market and adoption of noninvasive nerve stimulation products or devices. And we believe that acceleration will yield higher revenue growth. and be able to do it in a way that we're managing our costs and expenses. So ultimately speaking, can we accelerate our revenue while also reducing our overall cost to do that, whether that's a percentage of sales and marketing as a percentage of revenue as an indicator, so on and so forth. So those are really the 3 main catalysts that we're here focused on, and we're going to be very mindful about them as we go into the remainder of 2026 and beyond, so that we can give very specific milestone updates as to these different areas that we are strategically focused on. Mike, I don't know if you've got anything else you want add on.

Unknown Executive

Executives
#40

Jeremy, I'd just like to add in my opening comments, I talked about what I knew about the company before I got here as far as how clinically in-depth this location is and what they're doing to continue to enhance the strength of the clinical platform since joining the company and seeing Dr. Stats and his team and all the investigator-initiated research and the resources the company is putting behind the products to prove more and to do more is one of the reasons I'm extremely excited about the future.  So when you talk about acceleration, it's not just always using the same product as the same, and just trying to get momentum. It's building the platform that Josh has talked about. And that's what I believe is a really exciting factor of this company: what you will see in the future that we really can't discuss today, but the economics and the efforts are being placed here at electroCore to make it happen.

Operator

Operator
#41

Okay. We have now concluded the live Q&A portion of the call. With that, I will turn the call back over to Josh for closing remarks.

Joshua Lev

Executives
#42

Thank you, Amanda. I wanted to take the opportunity to thank our shareholders for your patience and your continued support. To our patients, our providers, and our partners, thank you for trusting us with your care and your time. And most importantly, to our team, thank you for showing up every day with the discipline and the ambition this opportunity demands. I really appreciate everyone's participation in today's call. We look forward to speaking with you again next quarter, and I wish you all a happy afternoon.

Operator

Operator
#43

That concludes today's call. Thank you for your participation.

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