NASDAQ:ECOR electroCore Q2 2024 Earnings Report $7.57 +0.02 (+0.26%) Closing price 04:00 PM EasternExtended Trading$7.62 +0.05 (+0.71%) As of 06:38 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast electroCore EPS ResultsActual EPS-$0.38Consensus EPS -$0.39Beat/MissBeat by +$0.01One Year Ago EPS-$1.03electroCore Revenue ResultsActual Revenue$6.14 millionExpected Revenue$5.85 millionBeat/MissBeat by +$290.00 thousandYoY Revenue GrowthN/AelectroCore Announcement DetailsQuarterQ2 2024Date8/7/2024TimeAfter Market ClosesConference Call DateWednesday, August 7, 2024Conference Call Time4:30PM ETUpcoming EarningselectroCore's Q1 2025 earnings is scheduled for Tuesday, May 6, 2025, with a conference call scheduled on Wednesday, May 7, 2025 at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by electroCore Q2 2024 Earnings Call TranscriptProvided by QuartrAugust 7, 2024 ShareLink copied to clipboard.There are 8 speakers on the call. Operator00:00:00and welcome to the electroCore Second Quarter 2024 Earnings Conference Call. At this time, all participants are in listen only mode. Please make sure you mute yourself. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. Operator00:00:23It is now my pleasure to introduce your host, John Goldberger. Thank you, sir. You may begin. Speaker 100:00:29Thank you all for participating in today's electroCore earnings call. My name is Dan Goldberger. I'm the Chief Executive Officer of electroCore, and I'm also a member of the Board of Directors. Joining me today is Brian Posner, Chief Financial Officer. Earlier today, electroCore published results for the Q2 ended June 30, 2024. Speaker 100:00:53A copy of the press release is available on the company's website. Before we begin, I'd like to remind you that management will make statements during the call that include forward looking statements within the meaning of the federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical facts should be deemed to be forward looking statements. All forward looking statements, including without limitation any guidance, outlook or future financial expectations or operational activities and performance are based upon the company's current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward looking statements. Speaker 100:01:53Accordingly, you should not place undue reliance on these statements. For a list of the risks and uncertainties associated with the company's business, please see the company's filings with the Securities and Exchange Commission. ElectroCore disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward looking statements, whether because of new information, future events or otherwise. This conference call contains time sensitive information that is accurate only as of the live broadcast today, August 7, 2024. ElectroCore was founded in 2,005 to commercialize the use of our proprietary noninvasive vagus nerve stimulation for medical and general wellness applications. Speaker 100:02:47The vagus nerve is the longest cranial nerve in the body bringing information from the visceral organs to the brain. Stimulating the vagus nerve affects many important autonomic functions in the brain and in the body, including neurotransmitter levels, inflammation levels and metabolism. Surgically implanted vagus nerve stimulators have been available from other companies for more than 40 years for chronic conditions like epilepsy and depression, so a large and growing database confirms the safety and efficacy of the tech team. Building on that science, electroCore pioneered noninvasive vagus nerve stimulation, and our products are now available by prescription for certain headache conditions and without a prescription for general wellness and human performance. Our pipeline of potential future indications and products continues to grow as clinicians, researchers and wellness advocates conduct investigator initiated trials to become more familiar with the benefits of noninvasive vagus nerve stimulation. Speaker 100:03:53We are excited to report our 7th consecutive record revenue quarter at $6,100,000 for the 3 months ended June 30, 2024, a 73% increase over the prior year. That's a 69% 5 year compound annual growth rate. We reported 86% gross margins and a 46% reduction in the company's net loss from the same period in 2023. We continue to make progress towards positive cash flow as revenue increases, gross margin expands and we maintain discipline around operating expenses. Brian will discuss the financials in more detail later in the call. Speaker 100:04:38We launched our U. S. Prescription headache business in 2017, selling primarily to specialty pharmacies. Since then, prescription headache business has grown worldwide, including sales that are covered by national health systems, such as the VA hospital system in the United States and the National Health Service in the United Kingdom, cash pay sales through prescriber professional channels and through certain managed care systems in the United States. We launched 2 new non prescription general wellness product lines last year. Speaker 100:05:11Truvega is a direct to consumer health and wellness brand, and Tac Stim is our brand for human performance for active duty military personnel. Truvega sales exceeded our expectations for the quarter. We reported small TaxDIM sales for the quarter, but added substantially to the funnel of future opportunities. The VA hospital system continues to be our largest revenue channel. You'll recall that our gammaCore prescription therapy is free to patients covered by Veterans Administration benefits, representing about 9,000,000 covered lives across approximately 1300 healthcare facilities. Speaker 100:05:48Sales in the VA channel grew 120% to $4,600,000 in the Q2 of 2024 from $2,100,000 during the Q2 of 2023. 160 VA facilities have purchased prescription gammaCore products through June 30, 2024, as compared to 138 through June 30, 2023. The VA Hospital Administration Headache Centers of Excellence estimates approximately 600,000 patients are being treated for headache in the VA hospital system. We've dispensed gammaCore devices to within the VA system. We use several contracting mechanisms to support sales to individual VA facilities, including open market access, our federal supply services contract and our distribution agreement with Level Government Services. Speaker 100:06:51During the Q2 of 2024, sales through Level accounted for approximately 27% of our VA sales, up from 13% during the Q1 of 2024. Truvega is currently positioned as a direct to consumer general wellness product for stress, relaxation, sleep and mental acuity. For the Q2 of 2024, total Truvega net sales were approximately $572,000 as compared to $290,000 during the Q2 of 2023. Our revenue return on advertising spend, what the industry calls a media efficiency ratio or MER, was approximately 2.81 Speaker 200:07:39in the Speaker 100:07:392nd quarter. In other words, we're spending $1 to generate $2.81 of revenue. Truvega return rates increased slightly to approximately 10% of shipments. In April 2024, we launched Truvega Plus, our second Truvega product offering. Truvega Plus is a mobile app enabled general wellness product. Speaker 100:08:02The 1st few months of sales of Truvega Plus have again exceeded expectations, and we are enthusiastic about the potential our new mobile app enabled product provides for future iterations of our technology and engagement with consumers. Since launching Truvega Plus, we sold approximately 1200 handsets and customers have conducted approximately 60,000 sessions using the mobile app. We believe that the Truvega business can scale nicely if we maintain or improve these metrics. Most of our Truvega revenue is generated through our e commerce platform, www.truvega.com. Following the successful launch of Truvega Plus, we are exploring other channels to reach consumers, including influencers, affiliates and resellers. Speaker 100:08:53PAC SYM for human performance is being sold to select Air Force Special Forces and Army Special Forces units for accelerated training, sustained attention, reduced fatigue and improved movement as defined by the Air Force Research Laboratory or AFRL. No prescription is required, and more information is available at www.taxstim.com. For the Q2 ended June 30, 2024, we recorded $55,000 of TaxDim sales as compared to $311,000 during the same period last year. We announced the commercial launch of our 2nd generation TacxDIM handset in June 20 24. This version was developed in collaboration with AFRL, and we believe that at least some TacxDIM sales were deferred as customers waited for the new handset. Speaker 100:09:47We have a growing sales funnel for TaxDIM, and we continue to believe that revenue from this product line is likely to be lumpy as active duty units purchased in bulk for pilot deployment. To that end, we expect revenues for TaxDIM in the 3rd quarter and back half of twenty twenty four to be higher than in the second quarter and first half of twenty twenty four, respectively. Our U. S. Prescription gammaCore channel, including GC Direct and G Concierge, recorded revenue of $476,000 during the Q2 of 2024, up 7% from $445,000 in the Q2 of 2023. Speaker 100:10:27There were 2,200 and 16 cumulative revenue generating cash paid prescribers as of June 30, 2024, up from 1451 on June 30, 2023. We previously stated that we expect at least some of these customers to migrate to the Truvega brand as awareness grows, so we are modeling flat revenue from this category for the time being. We began to experience that migration during the quarter as certain G concierge customers are evaluating the Truvega product line. Last year, we announced a distribution agreement with Terence Healthcare LLC that we believe will add more than 12,500,000 covered lives within a select managed care health system. The business model with Jurns is similar to how we work with the VA hospital system. Speaker 100:11:17Jurns handles adjudications, billing and collection, while electroCore ships directly to patients and provides in servicing and patient support. Our field sales team is responsible for building awareness among clinicians within those managed care systems. We continue to work with Journeys on the implementation, including the expansion into new geographic territories. Our field sales function is developing champions within the targeted managed care system. And while it is taking longer than we had hoped, we still believe Jiren's could be an important source of revenue growth in the second half of twenty twenty four and beyond. Speaker 100:11:54Revenue from channels outside of the United States, OUS, increased by 9% to $464,000 in the second quarter of 2024 as compared to $424,000 for the Q2 of 2023. Most of our OUS revenue continues to be generated in the United Kingdom by prescription gammaCore sales funded by the National Health Service or NHS. Now I'd like to turn to our scientific progress. Last week, we announced that the Air Force Research Laboratories published a paper entitled Transcutaneous Cervical Vagus Nurse Stimulation Enhances Second Language Vocabulary Acquisition while simultaneously mitigating fatigue and promoting focus in the journal Scientific Reports. The paper is based on a study that was conducted at the Defense Language Institute in Monterey, California, U. Speaker 100:12:48S. Department of Defense's premier language and was supported by the DARPA targeted neuroplasticity training program. The paper showed a significant positive effect of NVNS on language recall. Paper goes on to document that the recall advantage that emerged during training was sustained after the completion of treatment. 2 of our investigator initiated trials, the acute stroke trial in Leiden, Netherlands and the Gait and Mobility trial in Parkinson's disease in Newcastle, United Kingdom have been fully enrolled, and we expect to report top line data later this year. Speaker 100:13:26We continue to work with the FDA on a pathway for post traumatic stress or PTSD label, but that time line continues to be uncertain. We'll provide updates about our pipeline and other opportunities as they become available. Now I'd like to turn the call over to Brian for a review of our financials. Brian? Speaker 200:13:48Thank you, Dan. Net sales for the 3 months ended June 30, 2024 were $6,100,000 an increase of 73% as compared to $3,600,000 during the 3 months ended June 30, 2023. The increase of $2,600,000 is due to an increase in net sales across the majority of our major channels, including our prescription gammaCore medical devices sold to the U. S. And abroad and revenue from the sales of our non prescription general wellness Trivega brand. Speaker 200:14:21Gross profit increased by $2,300,000 for the 3 months ended June 30, 2024, compared to the 3 months ended June 30, 2023. Gross margin increased to 86% in the 3 months ended June 30, 2024, as compared to 84% for the 3 months ended June 30, 2023. Total operating expenses in the Q2 of 2024 were approximately $7,900,000 as compared to $8,000,000 in the Q2 of 2023. Research and development expense in the Q2 of 2024 was $600,000 as compared to $1,200,000 in the second quarter of 2023. This decrease is primarily due to a significant reduction in investments. Speaker 200:15:11Selling, general and administrative expense of $7,300,000 for the 3 months ended June 30, 2024 increased $458,000 or 7 percent as compared to $6,800,000 for the comparable period in 2023. This increase was primarily due to our greater variable selling and marketing costs consistent with our increase in sales. GAAP net loss for the Q2 of 2024 was $2,700,000 or $0.38 per share as compared to the $4,900,000 net loss or $1.03 per share for the Q2 of 2023. This significant improvement was primarily due to the increase in net sales to $6,100,000 for the Q2 of 2024. Adjusted EBITDA net loss in the Q2 of 2024 was $1,900,000 as compared to adjusted EBITDA net loss of $4,500,000 in the Q2 of 2023. Speaker 200:16:15These improved results are also primarily due to the 73 percent increase in the Q2 2024 net sales. A reconciliation of GAAP net loss to non GAAP adjusted EBITDA net loss has been provided in the financial statement tables included in today's press release. Cash, cash equivalents, marketable securities and restricted cash at June 30, 2024 totaled approximately $14,500,000 as compared to approximately 10.6 $1,000,000 as of December 31, 2023. In June 2024, the company raised net proceeds of approximately $9,000,000 through a registered direct offering and concurrent private placements priced at the market under NASDAQ rules. And now I'll turn the call back over to Dan. Speaker 100:17:07Thank you, Brian. I am incredibly proud of our continually growing revenue and the operating leverage we're seeing in the business. Our operating metrics, especially revenue and gross margin, continue to expectations, and I'm very enthusiastic about the company's long term prospects across all brands and product lines. Demand for our prescription gammaCore therapy in the VA channel continues to grow based on clinical performance and our increased presence in the field. Our FSS contract has been extended to September 14, 2024, and we continue working with our VA contract specialists to secure a new follow on contract. Speaker 100:17:48We have approximately 40 straight commission sales agents representing about 90 1099 reps in the field, managed by our small team territory business managers and supported by our customer experience team. This hybrid structure is very scalable as we deploy prescription gammaCore around the country. The Truvega Plus launch has been favorably received by the market. The brand continues to show tons of potential as a direct to consumer general wellness offering. We're selling Truvega products through our e commerce site, www.truvega.com, and we will explore expanding the Truvega proposition through Speaker 300:18:33new Speaker 100:18:36from different branches of our active duty military continues to develop for our Tacx SIM products. Q2 2024 sales of Tacx were impacted by the timing of the launch of our new handset and should resume in the back half of the year. We expect the TaxDIM revenue will be hard to predict in the short term as active duty units evaluate and purchase in bulk for pilot deployment. Longer term, we continue to believe that there may be civilian crossover as first responders, elite athletes, transportation workers, traders and e gamers become aware of the human performance benefits published so far. During the Q2 of 2024, our sales and marketing expense increased by approximately $286,000 over the Q2 of 2023, while sales grew by $2,600,000 Most of the top line revenue growth of $2,600,000 dropped to the bottom line as our net cost declined by $2,200,000 signaling real leverage in the P and L. Speaker 100:19:42Further out, we're working towards establishing additional indications for prescription gammaCore to treat post traumatic stress disorder, opioid use disorder and other clinical opportunities. In June 2024, we raised net proceeds of approximately $9,000,000 through a registered direct offering in concurrent private placements priced at the market under NASDAQ rules. We had $14,500,000 of cash and equivalents at June 30, 2024, and we will maintain discipline around fixed operating expenses. We expect that commissions and media spend will scale with revenues and we model approximately 30% of related sales on a blended basis. Therefore, we expect that our cash used continue to decline sequentially as revenue increases. Speaker 100:20:33In summary, I believe the business is demonstrating operating leverage and we will have a variety of levers to pull to continue growing the business. I'm confident that we can generate positive cash flow early next year with the financial resources on our balance sheet at June 30, 2024. At this time, I'll turn the call over to the operator. Operator, please open the line for questions. Operator00:21:01Thank you. We will now be conducting the question and answer session. Your first question comes from Jeffrey Cohen with Ladenburg Thalmann. Speaker 400:21:32Hey, Dan and Brian. How are you? Speaker 300:21:35Hey, Jeff. Hey, Jeff. Speaker 400:21:38Okay. So I've got a bond summer short though. Shares outstanding where we are currently as far as a good number, 7.1? Speaker 200:21:50We have $4,600,000 outstanding and then about another $1,600,000 of prefunded warrants that get into the go into the EPS calculation. Speaker 400:22:01So what did you use this quarter, $705,000,000 Speaker 200:22:07Yes. For this quarter, on the table was an average of 7,000,000 dollars 7,046,000,000 Speaker 400:22:21That reflects the churn ratio. Speaker 200:22:24That's correct. Speaker 400:22:27Okay, got it. So thanks for that. And while I have you on, Brian, what was cash loss for the quarter? I got the adjustment number of $1,900,000 and the GAAP $2,700,000 What was the cash number? Speaker 200:22:41The cash used from operations was about a little bit under $1,800,000 Speaker 400:22:47Okay. Fantastic. Okay. So couple other questions, I guess, I wanted to get a little more device related. So the 2nd gen tax in black that I saw, Dan, that's going to be back half stronger than front half, perhaps sequentially based, but probably lumpy and a bit shy of what we previously thought. Speaker 400:23:15That's more like, I don't know, dollars 1,000,000, dollars 1,500,000 full year maybe? Speaker 100:23:23That's I've got visibility to at least that number. The deliveries this quarter were held back waiting for the official launch of the new generation. So those are good numbers for walking around with and it will be we have a large commitment in the Q4 for delivery in October. So we're pretty comfortable with the range that you have. Speaker 400:23:54Got it. Okay. And maybe talk a little bit about ex U. S. And we've heard a lot about the NHS in the U. Speaker 400:24:01K. With gammaCore, but other territories, other territories prescription wise as well as other territories DTC wise? Speaker 100:24:10So yes, U. K, we have expectations that it will continue to grow sort of mid single digits in the 4%, 5%, 6% range. It's a steady Eddie kind of a business. And we do not have visibility on other geographies getting into Okay, got it. And currently commercial wise, Speaker 400:24:37Okay, got it. And currently commercialize the Truvega versus the Plus, the differential is the 352 minute sessions on the regular Truvega and the TRUVGA Plus, which is unlimited with the fancy different colored caps available? Speaker 100:25:02Correct. Speaker 400:25:04Okay. And that's $2.99 again to $2.99 Speaker 100:25:07That's exactly how our marketing folks would like you to describe it. Speaker 400:25:10Yes. I wasn't sure if I wanted the pink or the green one, but I went for the somewhat translucent charcoal color. Just saying. Excellent. Excellent. Speaker 400:25:21Okay. Excellent. I got it. And so U. S. Speaker 400:25:26Payers in the case of prescription focus, I know you're working on Juren, does it feel like more U. S. Payers can come around, could there be a point, perhaps Medicare as well, where in another 0 to 2 or 3, like there's a large amount of payers being covered? Speaker 100:25:47So we're really focused on getting traction and penetration in the Jerns managed care relationship, and we think that's going to be an excellent benchmark or reference case for the more traditional national and regional payers. We do have had some small payer wins among the regional payers, some of the blue fruit of the blues in local geographies, but we're really with a small team, we're focused on making the Jerns managed care relationship really jump out later this year. Speaker 400:26:29Got it. And then lastly, talk about those 2 papers, 1 on stroke, 1 on gate, the second one is in the U. K. First one is where and when will we see that and we'll be at a conference? Speaker 100:26:41So, yes, so the stroke trial is being done in Leiden in the Netherlands and was fully enrolled in the first quarter of this year. And these are both investigator initiated trials. We have no influence on the timing of when the data is going to be available. They're both European trials, 1 in the U. K, 1 in Netherlands. Speaker 100:27:07And better than I do that academics take the summer off. So it's been a little bit frustrating getting any communication from them in the short run. But I'm looking forward to being able to speak more clearly about the top line data for the end of the year. Speaker 400:27:23Okay, perfect. Thanks for taking all my questions. Appreciate it. Speaker 100:27:27Of course, Jeffrey. Thanks for your support. Operator00:27:31Your next question comes from Anthony Vendetti with Maxim Group. Speaker 500:27:36Thank you. So Dan, so the commercial payers, I know that's something you're working on. I know that it takes time as we know, but maybe just an update on where you are with some of them and what the expectation is for the rest of this year in 2025? Speaker 100:27:57Yes. So the VA hospital system is fully reimbursed for veterans that are covered by the VA hospital system. In the Jerns managed care system, which is larger as measured by covered lives. We went on formulary in January of this year, and it's really now more of a develop clinical champions and get penetration within the system than it is getting payers. So that's what our field sales team is focused on right now is demonstrating clinical adoption and driving penetration of that health care system. Speaker 100:28:48And similar to Mr. Collins' question, we really want to demonstrate that we can grow the business before we start directing resources to some of the other more traditional national payers in 2025. Speaker 500:29:08Okay. Makes sense. And then would you attribute the year over year decline in TaxDIM to the maybe anticipation of your commercial launch of the next generation TacxDIM? Speaker 100:29:24Yes. That's exactly what I was trying to say is that the Air Force and Army are very were very aware, very closely involved in the development of the new version of TaxDIM. And so all of those orders were deferred until we reliably supply the new heavier black handset. Speaker 500:29:48Okay. Makes sense. And then lastly, just I know there's a number of potential applications for the gammaCore. What is the next one you intend to hone in on and focus the team on? Speaker 100:30:04Yes. So PTSD, we announced breakthrough designation a few years ago. We've been working with the agency on the path forward to get a specific indication for PTSD. Substance abuse, there's a pivotal trial that's being sponsored by NIDA, National Institute on Drug Abuse that is enrolling patients and will read out in the beginning of next year. So those will be the next two sort of categories of label extensions that we're looking for VEGASAR simulation. Speaker 500:30:43Perfect, great. Thank you so much. I'll hop back in the queue. Appreciate Speaker 100:30:45it. Thanks, Anthony. Operator00:30:50Your next question comes from Sean Lee with H. C. Wainwright. Speaker 600:30:55Hi, good afternoon. This is Sean standing in for RK. Thanks for taking my questions. Speaker 100:31:01Hi, Sean. Of course. Speaker 600:31:03Hi, guys. So with VA still being your biggest customer and the U. S. Federal fiscal year coming up soon, I was wondering if you could elaborate a bit more on the contract extensions and how that's going on. Can we should we expect any changes for next year? Speaker 600:31:21Are there any extensions that you could go into? Thanks. Speaker 100:31:27So yes, so we're working with the contract agent to get a new 5 year FSS contract. That office has just been slow. And as a result of their backup, they've been giving us these 3 month extensions, which is frustrating, but it doesn't impact our business on a regular basis. Do expect to get a small price increase through that process. A larger percentage of our business is going through level, where the economics are slightly more favorable level. Speaker 100:32:09You may recall, is a small service disabled veteran owned small business. They did 13% of our VA hospital business in the Q1. They did 27% of a larger number in the Q2, and we're perfectly comfortable moving a larger portion of the business to their contracting mechanism and having multiple channels to be able to service that customer. Speaker 600:32:45Great. Thanks for that. And my second question is on the in the prepared remarks, you mentioned the effectiveness of vagus nerve stimulation for accelerating language learning. Just wondering, is that something that's specific to Tactin or is that also applicable to Truvega and do Speaker 300:33:03you have any plans to market towards that? Speaker 100:33:08So the trial was done with gammaCore headsets. So and then it was funded by the Department of Defense. The clinical results absolutely transferred to TaxDIM and could probably be inferred for Truvega, but Truvega delivers a lower dose. So you would need more sessions with Truvega to get the same mental acuity benefits. But the more general comment is yes, it's fundamental. Speaker 100:33:48The learning advantage, the cognitive enhancement is fundamental to the way this vagus nerve stimulation works and should be applicable across our product lines. Operator00:34:09Your next question comes from Tyler Lachlan with Brookline Capital Markets. Speaker 700:34:23I got two quick ones for you. I don't know if I missed it during the presentation or not. Do you happen to have an updated VA DoD facility count for this quarter? Speaker 200:34:34160. Speaker 100:34:35The number that we reported on the prepared remarks was 160. Speaker 400:34:42Okay. 160. Thanks. Speaker 300:34:43I must have missed it in there. And my second quick question Speaker 700:34:46for you. So the language learning data was very interesting. I noticed on clinicaltrials.gov, there were a few new indications that had popped up from independent investigators, amyloid clearance or supplemental clearance and then also the VA running, looks like an alcohol use disorder trials. Do you have any comments on those those new kind of indications or studies? Speaker 100:35:12Yes. So the alcohol is a spin out of the work that's being done on opioid use that Knight is supporting and the pilot results are very compelling. These are all investigator initiated trials, so we're not necessarily privy to the structure of the trial. And in many cases, we're actually selling handsets to the investigators who have independent funding. So we don't have a of input. Speaker 100:35:52But we love the research interest and it all adds to the body of knowledge around vagus nerve stimulation and could lead to future Speaker 700:36:02indications. Great. Well, thank you guys very much. Appreciate the time. Speaker 100:36:08Yes. Thanks. Operator00:36:12Your next question comes from Walter Schenker with MAZ Partners. Speaker 100:36:22Walter, your Operator00:36:23line is open. Speaker 300:36:25Yes, if I take myself off mute, it works better than if I leave the mute button on. Speaker 100:36:30We hear you better now, Walter. How are you? Speaker 300:36:33Okay. Well, I'm good. And my plug on the thing, my wife is good too as an enthusiastic user of the device. We both are. I've got my brother-in-law, a whole bunch of people. Speaker 300:36:46It would be correct that the majority of the dollars raised in the recent equity raise was raised from people who are either in management or in some way affiliated with the company? Speaker 100:37:01Absolutely. Yes, directors and officers. Speaker 300:37:05Right. So they put in $5,000,000 odd dollars of the $9,000,000 correct? Speaker 200:37:12More than that. Probably closer to Speaker 300:37:14$7,000,000 I know it's more. Okay. It's worth pointing out to people it's unusually strong result for a small company. Not a setup question. It's frustrating to me as an investor, given all of the interest in the VA system, the additional research, the fact that they are the people who have done most Speaker 400:37:44of the work on the Speaker 300:37:45PTSD and we you've indicated, although there's no hard data, there's some degree of use off label beyond headaches, that still the penetration either in the headache area or broadly in the VA system is so low. Is there a partner or something I know level has really upped the game, I guess. Is there some way, except hospital by hospital, region by region, to get a real step up in penetration given how few of the hospitals after all this time you're in? Speaker 100:38:24Yes. Look, Walter, it's a great observation. I do think, and if you talk to our sales leadership, that we're starting to see a bit of a tipping point where there's good recognition awareness that the technology is available for headache and is available for some of these behavioral health indications off label. And I think you're going to start to see that penetration accelerating as we roll into 2025. We're always open to partnerships. Speaker 100:39:07We've had a variety of conversations, but nothing that's close enough to really start to brag about. Speaker 300:39:15Good. And lastly, again, a comment I made this to you, but I want to make it again, especially for the Truvega Plus, and you've mentioned this, more is better in using vagus nerve your technology in vagus nerve stimulation. And that 2 minutes twice a day is not as good as 4 minutes twice a day or 4 minutes 3 times or 4 times a day, which all my wife does. And I think it's useful and important either on the side or broadly to continue to explain and try and inform people that if you use it more, it enhances even going back to learning where you said because the people in the trial used higher levels of simulation, it gets to the same place you'd have to use the consumer product more time. There really needs to be a greater push by the company that more is better, as opposed to just 2, again, 2 minutes twice a day is not really a great place to be. Speaker 300:40:32You should be using it more. Speaker 100:40:35You're absolutely right. I think you'll start to see that in our marketing and advertising or promotional information, especially when you're looking at the wellness opportunities for mental acuity, for focus, for quality of sleep, you're absolutely right, Walter. All of the data shows that more sessions leads to better outcomes. And but of course, you have to trade off the convenience for the consumer and end user, how much time they're willing to devote to getting those general wellness benefits. But in my personal experience, I do it quite frequently, especially on a stressful day like today. Speaker 300:41:29And it's easy enough to use watching TV, looking at your computer, doing other stuff if your hands don't eat your hands while you're doing it, just to sit there and do it's pretty easy. Okay, my head's done. Thank you, Dan. Speaker 100:41:43Thank you. We appreciate you, Walter. Have a great day. Operator00:41:49There are no further questions at this time. I would like to turn the call back over to Dan Goldberger for any closing comments. Speaker 100:41:56Thank you, operator, and thank you all for joining today's call. Our employees are working tirelessly to deliver products and therapies that improve the health and wellness of patients and customers. The team has done a great job of staying nimble, scaling the business, creating operating leverage and responding to the needs of our customers. I also want to thank the health care professionals and their patients for their loyal support of Gammacore therapy and consumers for adopting our Truvega product for general wellness. Thank you all and have a good evening.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallelectroCore Q2 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) electroCore Earnings HeadlineselectroCore (NASDAQ:ECOR) Trading 14.6% Higher - Time to Buy?April 25 at 2:17 AM | americanbankingnews.comelectroCore announces new data presented on nVNSApril 17, 2025 | markets.businessinsider.comHere’s How to Claim Your Stake in Elon’s Private Company, xAIEven though xAI is a private company, tech legend and angel investor Jeff Brown found a way for everyday folks like you… To partner with Elon on what he believes will be the biggest AI project of the century… Starting with as little as $500.April 25, 2025 | Brownstone Research (Ad)electroCore, Inc. Reports Positive Data on gammaCore® for Treating Concussive Symptoms in Mild Traumatic Brain Injury at 2025 IBIA World CongressApril 17, 2025 | quiverquant.comgammaCore Non-Invasive Vagus Nerve Stimulation (nVNS) Shown to be Effective in Treating Concussive Symptoms Associated with Mild Traumatic Brain InjuriesApril 17, 2025 | globenewswire.comelectroCore to Participate at the Planet MicroCap ShowcaseApril 16, 2025 | globenewswire.comSee More electroCore Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like electroCore? Sign up for Earnings360's daily newsletter to receive timely earnings updates on electroCore and other key companies, straight to your email. Email Address About electroCoreelectroCore (NASDAQ:ECOR), a commercial stage bioelectronic medicine and wellness company, provides non-invasive vagus nerve stimulation technology platform in the United States, the United Kingdom, and internationally. The company is developing gammaCore, a prescription only handheld device intended for regular or intermittent use for the acute treatment of pain associated with migraine and episodic cluster headache, as well as for the treatment of hemicrania continua and paroxysmal hemicrania. It also develops Truvaga for the support of general health and wellbeing; and TAC-STIM for human performance. In addition, the company offers gammacore Sapphire, a portable, reusable, rechargeable, and reloadable prescription medical device for various primary headache conditions. electroCore, Inc. was incorporated in 2005 and is headquartered in Rockaway, New Jersey.View electroCore ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Market Anticipation Builds: Joby Stock Climbs Ahead of EarningsIs Intuitive Surgical a Buy After Volatile Reaction to Earnings?Seismic Shift at Intel: Massive Layoffs Precede Crucial EarningsRocket Lab Lands New Contract, Builds Momentum Ahead of EarningsAmazon's Earnings Could Fuel a Rapid Breakout Tesla Earnings Miss, But Musk Refocuses and Bulls ReactQualcomm’s Range Narrows Ahead of Earnings as Bulls Step In Upcoming Earnings Cadence Design Systems (4/28/2025)Welltower (4/28/2025)Waste Management (4/28/2025)AstraZeneca (4/29/2025)Booking (4/29/2025)DoorDash (4/29/2025)Honeywell International (4/29/2025)Mondelez International (4/29/2025)PayPal (4/29/2025)Regeneron Pharmaceuticals (4/29/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 8 speakers on the call. Operator00:00:00and welcome to the electroCore Second Quarter 2024 Earnings Conference Call. At this time, all participants are in listen only mode. Please make sure you mute yourself. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. Operator00:00:23It is now my pleasure to introduce your host, John Goldberger. Thank you, sir. You may begin. Speaker 100:00:29Thank you all for participating in today's electroCore earnings call. My name is Dan Goldberger. I'm the Chief Executive Officer of electroCore, and I'm also a member of the Board of Directors. Joining me today is Brian Posner, Chief Financial Officer. Earlier today, electroCore published results for the Q2 ended June 30, 2024. Speaker 100:00:53A copy of the press release is available on the company's website. Before we begin, I'd like to remind you that management will make statements during the call that include forward looking statements within the meaning of the federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical facts should be deemed to be forward looking statements. All forward looking statements, including without limitation any guidance, outlook or future financial expectations or operational activities and performance are based upon the company's current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward looking statements. Speaker 100:01:53Accordingly, you should not place undue reliance on these statements. For a list of the risks and uncertainties associated with the company's business, please see the company's filings with the Securities and Exchange Commission. ElectroCore disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward looking statements, whether because of new information, future events or otherwise. This conference call contains time sensitive information that is accurate only as of the live broadcast today, August 7, 2024. ElectroCore was founded in 2,005 to commercialize the use of our proprietary noninvasive vagus nerve stimulation for medical and general wellness applications. Speaker 100:02:47The vagus nerve is the longest cranial nerve in the body bringing information from the visceral organs to the brain. Stimulating the vagus nerve affects many important autonomic functions in the brain and in the body, including neurotransmitter levels, inflammation levels and metabolism. Surgically implanted vagus nerve stimulators have been available from other companies for more than 40 years for chronic conditions like epilepsy and depression, so a large and growing database confirms the safety and efficacy of the tech team. Building on that science, electroCore pioneered noninvasive vagus nerve stimulation, and our products are now available by prescription for certain headache conditions and without a prescription for general wellness and human performance. Our pipeline of potential future indications and products continues to grow as clinicians, researchers and wellness advocates conduct investigator initiated trials to become more familiar with the benefits of noninvasive vagus nerve stimulation. Speaker 100:03:53We are excited to report our 7th consecutive record revenue quarter at $6,100,000 for the 3 months ended June 30, 2024, a 73% increase over the prior year. That's a 69% 5 year compound annual growth rate. We reported 86% gross margins and a 46% reduction in the company's net loss from the same period in 2023. We continue to make progress towards positive cash flow as revenue increases, gross margin expands and we maintain discipline around operating expenses. Brian will discuss the financials in more detail later in the call. Speaker 100:04:38We launched our U. S. Prescription headache business in 2017, selling primarily to specialty pharmacies. Since then, prescription headache business has grown worldwide, including sales that are covered by national health systems, such as the VA hospital system in the United States and the National Health Service in the United Kingdom, cash pay sales through prescriber professional channels and through certain managed care systems in the United States. We launched 2 new non prescription general wellness product lines last year. Speaker 100:05:11Truvega is a direct to consumer health and wellness brand, and Tac Stim is our brand for human performance for active duty military personnel. Truvega sales exceeded our expectations for the quarter. We reported small TaxDIM sales for the quarter, but added substantially to the funnel of future opportunities. The VA hospital system continues to be our largest revenue channel. You'll recall that our gammaCore prescription therapy is free to patients covered by Veterans Administration benefits, representing about 9,000,000 covered lives across approximately 1300 healthcare facilities. Speaker 100:05:48Sales in the VA channel grew 120% to $4,600,000 in the Q2 of 2024 from $2,100,000 during the Q2 of 2023. 160 VA facilities have purchased prescription gammaCore products through June 30, 2024, as compared to 138 through June 30, 2023. The VA Hospital Administration Headache Centers of Excellence estimates approximately 600,000 patients are being treated for headache in the VA hospital system. We've dispensed gammaCore devices to within the VA system. We use several contracting mechanisms to support sales to individual VA facilities, including open market access, our federal supply services contract and our distribution agreement with Level Government Services. Speaker 100:06:51During the Q2 of 2024, sales through Level accounted for approximately 27% of our VA sales, up from 13% during the Q1 of 2024. Truvega is currently positioned as a direct to consumer general wellness product for stress, relaxation, sleep and mental acuity. For the Q2 of 2024, total Truvega net sales were approximately $572,000 as compared to $290,000 during the Q2 of 2023. Our revenue return on advertising spend, what the industry calls a media efficiency ratio or MER, was approximately 2.81 Speaker 200:07:39in the Speaker 100:07:392nd quarter. In other words, we're spending $1 to generate $2.81 of revenue. Truvega return rates increased slightly to approximately 10% of shipments. In April 2024, we launched Truvega Plus, our second Truvega product offering. Truvega Plus is a mobile app enabled general wellness product. Speaker 100:08:02The 1st few months of sales of Truvega Plus have again exceeded expectations, and we are enthusiastic about the potential our new mobile app enabled product provides for future iterations of our technology and engagement with consumers. Since launching Truvega Plus, we sold approximately 1200 handsets and customers have conducted approximately 60,000 sessions using the mobile app. We believe that the Truvega business can scale nicely if we maintain or improve these metrics. Most of our Truvega revenue is generated through our e commerce platform, www.truvega.com. Following the successful launch of Truvega Plus, we are exploring other channels to reach consumers, including influencers, affiliates and resellers. Speaker 100:08:53PAC SYM for human performance is being sold to select Air Force Special Forces and Army Special Forces units for accelerated training, sustained attention, reduced fatigue and improved movement as defined by the Air Force Research Laboratory or AFRL. No prescription is required, and more information is available at www.taxstim.com. For the Q2 ended June 30, 2024, we recorded $55,000 of TaxDim sales as compared to $311,000 during the same period last year. We announced the commercial launch of our 2nd generation TacxDIM handset in June 20 24. This version was developed in collaboration with AFRL, and we believe that at least some TacxDIM sales were deferred as customers waited for the new handset. Speaker 100:09:47We have a growing sales funnel for TaxDIM, and we continue to believe that revenue from this product line is likely to be lumpy as active duty units purchased in bulk for pilot deployment. To that end, we expect revenues for TaxDIM in the 3rd quarter and back half of twenty twenty four to be higher than in the second quarter and first half of twenty twenty four, respectively. Our U. S. Prescription gammaCore channel, including GC Direct and G Concierge, recorded revenue of $476,000 during the Q2 of 2024, up 7% from $445,000 in the Q2 of 2023. Speaker 100:10:27There were 2,200 and 16 cumulative revenue generating cash paid prescribers as of June 30, 2024, up from 1451 on June 30, 2023. We previously stated that we expect at least some of these customers to migrate to the Truvega brand as awareness grows, so we are modeling flat revenue from this category for the time being. We began to experience that migration during the quarter as certain G concierge customers are evaluating the Truvega product line. Last year, we announced a distribution agreement with Terence Healthcare LLC that we believe will add more than 12,500,000 covered lives within a select managed care health system. The business model with Jurns is similar to how we work with the VA hospital system. Speaker 100:11:17Jurns handles adjudications, billing and collection, while electroCore ships directly to patients and provides in servicing and patient support. Our field sales team is responsible for building awareness among clinicians within those managed care systems. We continue to work with Journeys on the implementation, including the expansion into new geographic territories. Our field sales function is developing champions within the targeted managed care system. And while it is taking longer than we had hoped, we still believe Jiren's could be an important source of revenue growth in the second half of twenty twenty four and beyond. Speaker 100:11:54Revenue from channels outside of the United States, OUS, increased by 9% to $464,000 in the second quarter of 2024 as compared to $424,000 for the Q2 of 2023. Most of our OUS revenue continues to be generated in the United Kingdom by prescription gammaCore sales funded by the National Health Service or NHS. Now I'd like to turn to our scientific progress. Last week, we announced that the Air Force Research Laboratories published a paper entitled Transcutaneous Cervical Vagus Nurse Stimulation Enhances Second Language Vocabulary Acquisition while simultaneously mitigating fatigue and promoting focus in the journal Scientific Reports. The paper is based on a study that was conducted at the Defense Language Institute in Monterey, California, U. Speaker 100:12:48S. Department of Defense's premier language and was supported by the DARPA targeted neuroplasticity training program. The paper showed a significant positive effect of NVNS on language recall. Paper goes on to document that the recall advantage that emerged during training was sustained after the completion of treatment. 2 of our investigator initiated trials, the acute stroke trial in Leiden, Netherlands and the Gait and Mobility trial in Parkinson's disease in Newcastle, United Kingdom have been fully enrolled, and we expect to report top line data later this year. Speaker 100:13:26We continue to work with the FDA on a pathway for post traumatic stress or PTSD label, but that time line continues to be uncertain. We'll provide updates about our pipeline and other opportunities as they become available. Now I'd like to turn the call over to Brian for a review of our financials. Brian? Speaker 200:13:48Thank you, Dan. Net sales for the 3 months ended June 30, 2024 were $6,100,000 an increase of 73% as compared to $3,600,000 during the 3 months ended June 30, 2023. The increase of $2,600,000 is due to an increase in net sales across the majority of our major channels, including our prescription gammaCore medical devices sold to the U. S. And abroad and revenue from the sales of our non prescription general wellness Trivega brand. Speaker 200:14:21Gross profit increased by $2,300,000 for the 3 months ended June 30, 2024, compared to the 3 months ended June 30, 2023. Gross margin increased to 86% in the 3 months ended June 30, 2024, as compared to 84% for the 3 months ended June 30, 2023. Total operating expenses in the Q2 of 2024 were approximately $7,900,000 as compared to $8,000,000 in the Q2 of 2023. Research and development expense in the Q2 of 2024 was $600,000 as compared to $1,200,000 in the second quarter of 2023. This decrease is primarily due to a significant reduction in investments. Speaker 200:15:11Selling, general and administrative expense of $7,300,000 for the 3 months ended June 30, 2024 increased $458,000 or 7 percent as compared to $6,800,000 for the comparable period in 2023. This increase was primarily due to our greater variable selling and marketing costs consistent with our increase in sales. GAAP net loss for the Q2 of 2024 was $2,700,000 or $0.38 per share as compared to the $4,900,000 net loss or $1.03 per share for the Q2 of 2023. This significant improvement was primarily due to the increase in net sales to $6,100,000 for the Q2 of 2024. Adjusted EBITDA net loss in the Q2 of 2024 was $1,900,000 as compared to adjusted EBITDA net loss of $4,500,000 in the Q2 of 2023. Speaker 200:16:15These improved results are also primarily due to the 73 percent increase in the Q2 2024 net sales. A reconciliation of GAAP net loss to non GAAP adjusted EBITDA net loss has been provided in the financial statement tables included in today's press release. Cash, cash equivalents, marketable securities and restricted cash at June 30, 2024 totaled approximately $14,500,000 as compared to approximately 10.6 $1,000,000 as of December 31, 2023. In June 2024, the company raised net proceeds of approximately $9,000,000 through a registered direct offering and concurrent private placements priced at the market under NASDAQ rules. And now I'll turn the call back over to Dan. Speaker 100:17:07Thank you, Brian. I am incredibly proud of our continually growing revenue and the operating leverage we're seeing in the business. Our operating metrics, especially revenue and gross margin, continue to expectations, and I'm very enthusiastic about the company's long term prospects across all brands and product lines. Demand for our prescription gammaCore therapy in the VA channel continues to grow based on clinical performance and our increased presence in the field. Our FSS contract has been extended to September 14, 2024, and we continue working with our VA contract specialists to secure a new follow on contract. Speaker 100:17:48We have approximately 40 straight commission sales agents representing about 90 1099 reps in the field, managed by our small team territory business managers and supported by our customer experience team. This hybrid structure is very scalable as we deploy prescription gammaCore around the country. The Truvega Plus launch has been favorably received by the market. The brand continues to show tons of potential as a direct to consumer general wellness offering. We're selling Truvega products through our e commerce site, www.truvega.com, and we will explore expanding the Truvega proposition through Speaker 300:18:33new Speaker 100:18:36from different branches of our active duty military continues to develop for our Tacx SIM products. Q2 2024 sales of Tacx were impacted by the timing of the launch of our new handset and should resume in the back half of the year. We expect the TaxDIM revenue will be hard to predict in the short term as active duty units evaluate and purchase in bulk for pilot deployment. Longer term, we continue to believe that there may be civilian crossover as first responders, elite athletes, transportation workers, traders and e gamers become aware of the human performance benefits published so far. During the Q2 of 2024, our sales and marketing expense increased by approximately $286,000 over the Q2 of 2023, while sales grew by $2,600,000 Most of the top line revenue growth of $2,600,000 dropped to the bottom line as our net cost declined by $2,200,000 signaling real leverage in the P and L. Speaker 100:19:42Further out, we're working towards establishing additional indications for prescription gammaCore to treat post traumatic stress disorder, opioid use disorder and other clinical opportunities. In June 2024, we raised net proceeds of approximately $9,000,000 through a registered direct offering in concurrent private placements priced at the market under NASDAQ rules. We had $14,500,000 of cash and equivalents at June 30, 2024, and we will maintain discipline around fixed operating expenses. We expect that commissions and media spend will scale with revenues and we model approximately 30% of related sales on a blended basis. Therefore, we expect that our cash used continue to decline sequentially as revenue increases. Speaker 100:20:33In summary, I believe the business is demonstrating operating leverage and we will have a variety of levers to pull to continue growing the business. I'm confident that we can generate positive cash flow early next year with the financial resources on our balance sheet at June 30, 2024. At this time, I'll turn the call over to the operator. Operator, please open the line for questions. Operator00:21:01Thank you. We will now be conducting the question and answer session. Your first question comes from Jeffrey Cohen with Ladenburg Thalmann. Speaker 400:21:32Hey, Dan and Brian. How are you? Speaker 300:21:35Hey, Jeff. Hey, Jeff. Speaker 400:21:38Okay. So I've got a bond summer short though. Shares outstanding where we are currently as far as a good number, 7.1? Speaker 200:21:50We have $4,600,000 outstanding and then about another $1,600,000 of prefunded warrants that get into the go into the EPS calculation. Speaker 400:22:01So what did you use this quarter, $705,000,000 Speaker 200:22:07Yes. For this quarter, on the table was an average of 7,000,000 dollars 7,046,000,000 Speaker 400:22:21That reflects the churn ratio. Speaker 200:22:24That's correct. Speaker 400:22:27Okay, got it. So thanks for that. And while I have you on, Brian, what was cash loss for the quarter? I got the adjustment number of $1,900,000 and the GAAP $2,700,000 What was the cash number? Speaker 200:22:41The cash used from operations was about a little bit under $1,800,000 Speaker 400:22:47Okay. Fantastic. Okay. So couple other questions, I guess, I wanted to get a little more device related. So the 2nd gen tax in black that I saw, Dan, that's going to be back half stronger than front half, perhaps sequentially based, but probably lumpy and a bit shy of what we previously thought. Speaker 400:23:15That's more like, I don't know, dollars 1,000,000, dollars 1,500,000 full year maybe? Speaker 100:23:23That's I've got visibility to at least that number. The deliveries this quarter were held back waiting for the official launch of the new generation. So those are good numbers for walking around with and it will be we have a large commitment in the Q4 for delivery in October. So we're pretty comfortable with the range that you have. Speaker 400:23:54Got it. Okay. And maybe talk a little bit about ex U. S. And we've heard a lot about the NHS in the U. Speaker 400:24:01K. With gammaCore, but other territories, other territories prescription wise as well as other territories DTC wise? Speaker 100:24:10So yes, U. K, we have expectations that it will continue to grow sort of mid single digits in the 4%, 5%, 6% range. It's a steady Eddie kind of a business. And we do not have visibility on other geographies getting into Okay, got it. And currently commercial wise, Speaker 400:24:37Okay, got it. And currently commercialize the Truvega versus the Plus, the differential is the 352 minute sessions on the regular Truvega and the TRUVGA Plus, which is unlimited with the fancy different colored caps available? Speaker 100:25:02Correct. Speaker 400:25:04Okay. And that's $2.99 again to $2.99 Speaker 100:25:07That's exactly how our marketing folks would like you to describe it. Speaker 400:25:10Yes. I wasn't sure if I wanted the pink or the green one, but I went for the somewhat translucent charcoal color. Just saying. Excellent. Excellent. Speaker 400:25:21Okay. Excellent. I got it. And so U. S. Speaker 400:25:26Payers in the case of prescription focus, I know you're working on Juren, does it feel like more U. S. Payers can come around, could there be a point, perhaps Medicare as well, where in another 0 to 2 or 3, like there's a large amount of payers being covered? Speaker 100:25:47So we're really focused on getting traction and penetration in the Jerns managed care relationship, and we think that's going to be an excellent benchmark or reference case for the more traditional national and regional payers. We do have had some small payer wins among the regional payers, some of the blue fruit of the blues in local geographies, but we're really with a small team, we're focused on making the Jerns managed care relationship really jump out later this year. Speaker 400:26:29Got it. And then lastly, talk about those 2 papers, 1 on stroke, 1 on gate, the second one is in the U. K. First one is where and when will we see that and we'll be at a conference? Speaker 100:26:41So, yes, so the stroke trial is being done in Leiden in the Netherlands and was fully enrolled in the first quarter of this year. And these are both investigator initiated trials. We have no influence on the timing of when the data is going to be available. They're both European trials, 1 in the U. K, 1 in Netherlands. Speaker 100:27:07And better than I do that academics take the summer off. So it's been a little bit frustrating getting any communication from them in the short run. But I'm looking forward to being able to speak more clearly about the top line data for the end of the year. Speaker 400:27:23Okay, perfect. Thanks for taking all my questions. Appreciate it. Speaker 100:27:27Of course, Jeffrey. Thanks for your support. Operator00:27:31Your next question comes from Anthony Vendetti with Maxim Group. Speaker 500:27:36Thank you. So Dan, so the commercial payers, I know that's something you're working on. I know that it takes time as we know, but maybe just an update on where you are with some of them and what the expectation is for the rest of this year in 2025? Speaker 100:27:57Yes. So the VA hospital system is fully reimbursed for veterans that are covered by the VA hospital system. In the Jerns managed care system, which is larger as measured by covered lives. We went on formulary in January of this year, and it's really now more of a develop clinical champions and get penetration within the system than it is getting payers. So that's what our field sales team is focused on right now is demonstrating clinical adoption and driving penetration of that health care system. Speaker 100:28:48And similar to Mr. Collins' question, we really want to demonstrate that we can grow the business before we start directing resources to some of the other more traditional national payers in 2025. Speaker 500:29:08Okay. Makes sense. And then would you attribute the year over year decline in TaxDIM to the maybe anticipation of your commercial launch of the next generation TacxDIM? Speaker 100:29:24Yes. That's exactly what I was trying to say is that the Air Force and Army are very were very aware, very closely involved in the development of the new version of TaxDIM. And so all of those orders were deferred until we reliably supply the new heavier black handset. Speaker 500:29:48Okay. Makes sense. And then lastly, just I know there's a number of potential applications for the gammaCore. What is the next one you intend to hone in on and focus the team on? Speaker 100:30:04Yes. So PTSD, we announced breakthrough designation a few years ago. We've been working with the agency on the path forward to get a specific indication for PTSD. Substance abuse, there's a pivotal trial that's being sponsored by NIDA, National Institute on Drug Abuse that is enrolling patients and will read out in the beginning of next year. So those will be the next two sort of categories of label extensions that we're looking for VEGASAR simulation. Speaker 500:30:43Perfect, great. Thank you so much. I'll hop back in the queue. Appreciate Speaker 100:30:45it. Thanks, Anthony. Operator00:30:50Your next question comes from Sean Lee with H. C. Wainwright. Speaker 600:30:55Hi, good afternoon. This is Sean standing in for RK. Thanks for taking my questions. Speaker 100:31:01Hi, Sean. Of course. Speaker 600:31:03Hi, guys. So with VA still being your biggest customer and the U. S. Federal fiscal year coming up soon, I was wondering if you could elaborate a bit more on the contract extensions and how that's going on. Can we should we expect any changes for next year? Speaker 600:31:21Are there any extensions that you could go into? Thanks. Speaker 100:31:27So yes, so we're working with the contract agent to get a new 5 year FSS contract. That office has just been slow. And as a result of their backup, they've been giving us these 3 month extensions, which is frustrating, but it doesn't impact our business on a regular basis. Do expect to get a small price increase through that process. A larger percentage of our business is going through level, where the economics are slightly more favorable level. Speaker 100:32:09You may recall, is a small service disabled veteran owned small business. They did 13% of our VA hospital business in the Q1. They did 27% of a larger number in the Q2, and we're perfectly comfortable moving a larger portion of the business to their contracting mechanism and having multiple channels to be able to service that customer. Speaker 600:32:45Great. Thanks for that. And my second question is on the in the prepared remarks, you mentioned the effectiveness of vagus nerve stimulation for accelerating language learning. Just wondering, is that something that's specific to Tactin or is that also applicable to Truvega and do Speaker 300:33:03you have any plans to market towards that? Speaker 100:33:08So the trial was done with gammaCore headsets. So and then it was funded by the Department of Defense. The clinical results absolutely transferred to TaxDIM and could probably be inferred for Truvega, but Truvega delivers a lower dose. So you would need more sessions with Truvega to get the same mental acuity benefits. But the more general comment is yes, it's fundamental. Speaker 100:33:48The learning advantage, the cognitive enhancement is fundamental to the way this vagus nerve stimulation works and should be applicable across our product lines. Operator00:34:09Your next question comes from Tyler Lachlan with Brookline Capital Markets. Speaker 700:34:23I got two quick ones for you. I don't know if I missed it during the presentation or not. Do you happen to have an updated VA DoD facility count for this quarter? Speaker 200:34:34160. Speaker 100:34:35The number that we reported on the prepared remarks was 160. Speaker 400:34:42Okay. 160. Thanks. Speaker 300:34:43I must have missed it in there. And my second quick question Speaker 700:34:46for you. So the language learning data was very interesting. I noticed on clinicaltrials.gov, there were a few new indications that had popped up from independent investigators, amyloid clearance or supplemental clearance and then also the VA running, looks like an alcohol use disorder trials. Do you have any comments on those those new kind of indications or studies? Speaker 100:35:12Yes. So the alcohol is a spin out of the work that's being done on opioid use that Knight is supporting and the pilot results are very compelling. These are all investigator initiated trials, so we're not necessarily privy to the structure of the trial. And in many cases, we're actually selling handsets to the investigators who have independent funding. So we don't have a of input. Speaker 100:35:52But we love the research interest and it all adds to the body of knowledge around vagus nerve stimulation and could lead to future Speaker 700:36:02indications. Great. Well, thank you guys very much. Appreciate the time. Speaker 100:36:08Yes. Thanks. Operator00:36:12Your next question comes from Walter Schenker with MAZ Partners. Speaker 100:36:22Walter, your Operator00:36:23line is open. Speaker 300:36:25Yes, if I take myself off mute, it works better than if I leave the mute button on. Speaker 100:36:30We hear you better now, Walter. How are you? Speaker 300:36:33Okay. Well, I'm good. And my plug on the thing, my wife is good too as an enthusiastic user of the device. We both are. I've got my brother-in-law, a whole bunch of people. Speaker 300:36:46It would be correct that the majority of the dollars raised in the recent equity raise was raised from people who are either in management or in some way affiliated with the company? Speaker 100:37:01Absolutely. Yes, directors and officers. Speaker 300:37:05Right. So they put in $5,000,000 odd dollars of the $9,000,000 correct? Speaker 200:37:12More than that. Probably closer to Speaker 300:37:14$7,000,000 I know it's more. Okay. It's worth pointing out to people it's unusually strong result for a small company. Not a setup question. It's frustrating to me as an investor, given all of the interest in the VA system, the additional research, the fact that they are the people who have done most Speaker 400:37:44of the work on the Speaker 300:37:45PTSD and we you've indicated, although there's no hard data, there's some degree of use off label beyond headaches, that still the penetration either in the headache area or broadly in the VA system is so low. Is there a partner or something I know level has really upped the game, I guess. Is there some way, except hospital by hospital, region by region, to get a real step up in penetration given how few of the hospitals after all this time you're in? Speaker 100:38:24Yes. Look, Walter, it's a great observation. I do think, and if you talk to our sales leadership, that we're starting to see a bit of a tipping point where there's good recognition awareness that the technology is available for headache and is available for some of these behavioral health indications off label. And I think you're going to start to see that penetration accelerating as we roll into 2025. We're always open to partnerships. Speaker 100:39:07We've had a variety of conversations, but nothing that's close enough to really start to brag about. Speaker 300:39:15Good. And lastly, again, a comment I made this to you, but I want to make it again, especially for the Truvega Plus, and you've mentioned this, more is better in using vagus nerve your technology in vagus nerve stimulation. And that 2 minutes twice a day is not as good as 4 minutes twice a day or 4 minutes 3 times or 4 times a day, which all my wife does. And I think it's useful and important either on the side or broadly to continue to explain and try and inform people that if you use it more, it enhances even going back to learning where you said because the people in the trial used higher levels of simulation, it gets to the same place you'd have to use the consumer product more time. There really needs to be a greater push by the company that more is better, as opposed to just 2, again, 2 minutes twice a day is not really a great place to be. Speaker 300:40:32You should be using it more. Speaker 100:40:35You're absolutely right. I think you'll start to see that in our marketing and advertising or promotional information, especially when you're looking at the wellness opportunities for mental acuity, for focus, for quality of sleep, you're absolutely right, Walter. All of the data shows that more sessions leads to better outcomes. And but of course, you have to trade off the convenience for the consumer and end user, how much time they're willing to devote to getting those general wellness benefits. But in my personal experience, I do it quite frequently, especially on a stressful day like today. Speaker 300:41:29And it's easy enough to use watching TV, looking at your computer, doing other stuff if your hands don't eat your hands while you're doing it, just to sit there and do it's pretty easy. Okay, my head's done. Thank you, Dan. Speaker 100:41:43Thank you. We appreciate you, Walter. Have a great day. Operator00:41:49There are no further questions at this time. I would like to turn the call back over to Dan Goldberger for any closing comments. Speaker 100:41:56Thank you, operator, and thank you all for joining today's call. Our employees are working tirelessly to deliver products and therapies that improve the health and wellness of patients and customers. The team has done a great job of staying nimble, scaling the business, creating operating leverage and responding to the needs of our customers. I also want to thank the health care professionals and their patients for their loyal support of Gammacore therapy and consumers for adopting our Truvega product for general wellness. Thank you all and have a good evening.Read morePowered by