Greetings, and welcome to the electroCore Second Quarter 2023 Earnings Conference Call. [Operator Instructions]. It is now my pleasure to introduce your host, Dan Goldberger. Thank you, sir. You may begin.

Thank you all for participating in today's electroCore's earnings call. My name is Dan Goldberger. I'm the Chief Executive Officer of electroCore, and I am also a member of the Board of Directors. Joining me today is Brian Posner, our Chief Financial Officer. Earlier today, electroCore released results for the second quarter ended June 30, 2023. A 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 were 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 fact could 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. Accordingly, 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 9, 2023. We're thrilled to report another record revenue quarter with sales of $3.6 million for the 3 months ended June 30, 2023. That's a 65% increase over the prior year.…

Thank you, Dan. For the quarter ended June 30, 2023, electroCore reported net sales of $3.6 million compared to $2.2 million during the same period of 2022, which represents an approximately 65% increase over the prior year. The increase of $1.4 million is due to an increase in net sales across major U.S. channels, including the sale of our prescription gammaCore devices and revenue from the sales of our nonprescription human performance TAC-STIM and Truvaga products. Total operating expense in the second quarter of 2023 were approximately $8 million as compared to $7.6 million in the second quarter of 2022. Research and development expense in the second quarter of 2023 was $1.2 million as compared to $1.3 million in the second quarter of 2022. This decrease was due to a decrease in compensation associated with cost-cutting measures, offset by our targeted investments to support the future iterations of our nVNS delivery platform. Selling, general and administrative expense in the second quarter of 2023 was $6.8 million as compared to $6.3 million in the second quarter of 2022. This increase was due to our continuing targeted investments to support our commercial efforts, offset by decreases in insurance and stock-based compensation expense. GAAP net loss in the second quarter of 2023 was $4.9 million compared to the $5.3 million net loss in the second quarter of 2022. Adjusted EBITDA net loss in the second quarter of 2023 was $4.5 million as compared to a net loss of $4.9 million in the second quarter of 2022. 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. Net cash used in operating activities in the quarter ended June 30, 2023, was approximately $3.3 million as compared to $3.2 million…

Thank you, Brian. I'm very impressed with our second quarter 2023 operating results and with the continued momentum in our prescription headache business and bolstered balance sheet. We are increasingly enthusiastic about the company's long-term prospects. Continued investment in our cash pay and covered business models have greatly expanded the prescription gammaCore therapy market. As reflected by the continued revenue growth, number of facilities and number of prescribers realized in the second quarter of 2023, Truvaga has tons of potential as a direct-to-consumer wellness offering. We have started with an e-commerce business model, which will be the focus this year, and I look forward to launching a next-generation app-enabled product platform next year. Our metrics held strong during the second quarter of 2023 and we will continue to adjust our investment in all of our commercial channels as the year progresses. TAC-STIM 2.0 is a next-generation human performance product being financed in part by the Air Force Special Forces through their BOOST program. It could accelerate the adoption of nVNS for human performance among our active duty military in coming years. A pipeline of interest from different branches of the military continues to develop for our TAC-STIM product, which may result in expanded adoption in future quarters. We also believe that there will be civilian crossover as first responders, athletes, transportation workers and e-gamers become aware of the human performance benefits published so far. Demand for our prescription gammaCore therapy in the VA/DoD channel continues to grow based on clinical performance and our increased presence in the field. We have about 35 trade commission sales agents for 1099 reps in the field, managed by our small team of territory business managers and supported by our customer experience team. Note that our sales and marketing expense increased by approximately $550,000 in…

[Operator Instructions]. Our first question comes from John Vandermosten with Zacks.

Great. Dan and Brian, can you review the structure of the Reliefband arrangement and how the economics work for that?

So we haven't said very much publicly about it. We have signed a distribution agreement with Reliefband for their Reletex product that we're going to take to our channel in the VA hospital system. And it's early days, but it overlaps very nicely with our call point and with our broader mission of bringing neurostimulation devices to the health care marketplace.

Great. And TAC-STIM and Truvaga have really seemed to have come out pretty strong. And with regard to TAC-STIM, are there any national opportunities, international defense agencies perhaps that you can pursue there? And do you need clearance from the DoD to do that? And then perhaps also maybe the DoD could kind of be a conduit to talking to others? What do you think about the opportunity there in terms of international department?

Yes. You're exactly right over the long haul. In the short run, the Air Force and Army that we're working with are very confidential about how they're deploying our vagus nerve stimulation technology in their conversations with their colleagues in NATO. It has come up, but we don't have very much visibility on how aggressively they're going to offer it to our colleagues overseas. Truvaga, we have to go through some regulatory compliance issues, but I certainly expect that Truvaga is going to be available in Canada, in the United Kingdom and in the European Union as we roll into next year and get through some of those compliance issues.

Great. It sounds like a lot of opportunities there. And last question for me. You had mentioned that R&D is going to be going down, but I'm wondering how that might be allocated going forward? I think there's PTSD, OUD and perhaps there's been a lot of other small things that are potential out there. How do you see kind of, I guess, in a pie chart of breaking down R&D into those different areas?

Yes. So our largest chunk of R&D spend right now is in new product development. We're looking forward to launching our next-generation technology platform that's going to use a smartphone as a display and a control system and as a way to incorporate other wellness data from other devices in our own device. That is on track for product launch early next year. And so the R&D spend on product development is going to tail off as we go through the rest of this year and transition to pilot production and ultimately, building inventory for product line. We're working with the FDA around the de novo submission to extend our label to treat the symptoms of post-traumatic stress disorder. That data has already been collected. So it's not a large component of our R&D spend. The next level extension beyond that is to treat the symptoms of withdrawal from controlled substances like opioids. NIDA, the National Institute on Drug Abuse has awarded a $6 million grant to fund the pivotal trial in that indication. Dr. Bremner at Emory University and the VA hospital in Atlanta is the principal investigator for that trial. And so again, that's not going to hit our books because the pivotal trial is almost entirely funded by the NIDA grant. So we see our -- sorry for the long-winded explanation here, but we see our R&D expense declining over the course of this year and settling out at a much lower level through 2024.

Our next question comes from Swayampakula Ramakanth with H.C. Wainwright.

Thank you very much. A couple of questions. Starting over the high level. So you ended 6 months with $6.3 million revenue run and -- obviously, the guidance is beyond what we can annualize from that 6.3 number. So just trying to understand the cadence of revenues in terms of where do you think the contribution is going to come from? Obviously, you added close to 800-plus thousand from the new businesses, the Truvaga and TAC-STIM. Is that growth -- the additional growth that we are expecting, is that going to come from there? Or is it more as you're opening up more point of contact at the VA? Just trying to understand where this business is meant to grow for the next 6 months.

Yes, that's a great question, RK, and I appreciate it. So the good news is that from where we sit, all of our U.S. channels are really starting to accelerate through the current quarter, right? We're 1/3 of the way or more through the current quarter. The VA hospital system is our largest customer that grew 75% in the second quarter. We see that growth pace continuing and maybe even accelerating just in the VA hospital as we go through the back half of the year, driven a little bit because we're kind of at a tipping point now with sort of general acceptance that vagus nerve stimulation works very well in that population. And although we're having more and more success recruiting great commission sales reps, what we call 1099 reps. And so our network of feet on the street is growing very rapidly, and it's growing in a scalable way. So that's already our largest revenue line, and it's growing by the largest percent. Our prescription commercial sales has flattened out a bit this year compared to last year, but the big opportunity in our commercial prescription sales is the Joerns relationship that gives us access to Kaiser. We haven't reported any revenue from that channel. We will be reporting some small revenue in the current quarter. That's 12 million, give or take, covered live that are going to have access to gammaCore prescription therapy for headache now that we've got that agreement in place, and we've worked out the back-office issues. So I see a lot of greenfield growth from that new medical benefit available to Kaiser patent. Truvaga and TAC-STIM, both of those new products have really surprised us with their early adoption, still smaller numbers compared to our other channels, but a lot of room for growth. And we've said over and over again, that the TAC-STIM business could be very large in coming years, but it's going to be lumpy because it comes in on TOs [ph] or significant numbers of devices at a time. So it's hard for us to predict the timing, but the funnel for tax NPOs [ph] is large and growing.

And then on the TAC-STIM on the military business itself, to me, it's a little bit interesting in the sense you -- it's hardly 6 months since you started bringing in revenues. And you're already trying to think of a second-generation product there. So -- and I understand you can't talk too much about what's going on behind -- on the boardroom. But in general, how should we think about the second-generation products coming in? And is this going to create a second wave of revenues -- and what -- and how -- what will be the -- would TAC-STIM be gobbled up with a second generation coming in? Or you can market, both the first generation and the second-generation over the next -- at least over the next year, 1.5 years?

Yes. So very good question. And going forward, we need to do a better job of explaining what's going on. There are some pictures on the TAC-STIM, www.tac-stim.com website of the new military grade version of our noninvasive vagus nerve stimulator. That's a very rugged MIL-SPEC implementation of the technology that was largely finance -- the development of that product was largely financed by the Air Force Research Laboratories at Wright-Patterson Air Force Base. Completely separately, we are developing a platform for our, let's call it, civilian applications of vagus nerve stimulation that's going to be connected via Bluetooth to a smartphone. The DoD specifically does not want smartphone connections for all their various security reasons. So these are physically different products for different end users that are both fundamentally noninvasive vagus nerve stimulator. So I hope that's helpful. There are better pictures on our various websites of the different product configurations.

Okay. And then I'm sorry, I'm flipping back and forth. Then going back to the VA channel. Since the COVID ended, I had to be careful it might be coming back. You have had more interactions for the VA centers. So is the depth of your relationship with individuals at the VA increasing? And how much of that you have already recognized and how much of that is still on the table?

There is a tremendous amount of runway ahead of us, both in terms of the number of facilities that we have opened up and within any given facility, the number of departments that we have opened up. We generally start with neurology in any particular facility. Behavioral health is very interested in what we're doing, especially around PTSD and substance abuse. We have access now to women's health to pain management and in some cases, we're now getting into primary care in the VA hospital settings as well. So we have tremendous forward opportunity not just to open up new facilities, but to go deeper into our existing customer facilities.

Okay. One last question for Brian. So this quarter, you clocked 84% as gross margin. With the second-generation product coming up on the TAC-STIM business, and also with, at the same time, increasing in terms of volume of product leaving your facility, how should we think about gross margin, not just for '23, but in the short to midterm from here?

Yes. Yes, so I think we're going to -- we're pretty comfortable saying we're going to stay over 80%. We've been over 80% since late 2021 at this point. excluding onetime adjustments from time to time. So I think we're very comfortable that we'll be over 80% for the foreseeable future.

Our next question comes from Nick Sherwood with Maxim.

Congrats on the quarter. Can you give us any information on some of the demographic data that you -- or metrics that you've gotten from your e-commerce platform and digital marketing initiatives, sort of like which social media platforms you're driving traffic from and what sort of customers you're seeing that are coming in from these digital marketing initiatives?

Yes. Very good question. We have not given out much of that publicly. One of the metrics that we do watch carefully is we call it, the media efficiency rate. What do we spend on -- what we spend on media, which is overwhelmingly Internet versus the revenue that we're generating. And we're solidly -- and I think we said in the call that we're spending $1 on media to generate $2.20, $2.25 of revenue, which is very scalable. The vast majority of our spending so far has been on [indiscernible] and you can see that in the Google Analytics. We engaged an agency to help us with social media to develop creative material for us. That agency just started to come online in June and July. And so candidly, our social media metrics right now are anemic, but I'm looking forward now that this agency is kicking in to seeing some of that social media, Facebook, Instagram, TikTok. I don't think we're doing much on Twitter or X yet, but we're looking at a much more concerted campaign, not so much over the summer, but kicking in, in the fourth quarter and then running up to the launch of our next-generation product early next year.

[Operator Instructions]. Our next question comes from Tyler Bussian with Brookline Capital.

Dan and Brian. I've got some quick ones here for you. The first one is primarily based on kind of the second-generation device plans. So do you have any sense of -- are you going to be pushing those devices out through both the gammaCore and the Truvaga platforms? I know you already said it's not part of the TAC-STIM. Do you think you're going to do something separate for branding for that app connected device?

We're going to start in the consumer segment with our Truvaga brand. gammaCore Sapphire, our flagship prescription product has been our [indiscernible] but we do think that there's a segment of the prescription customer population that would prefer an app-enabled platform that can collect data and can record data, especially in the headache space, the notion of having a headache diary and diary is pretty common. So we do see rolling that out in the prescription space, but probably alongside of gammaCore Sapphire not to replace it.

Got it. So just for clarification. The plan is to take the current Truvaga device and fully replace all offerings with this app enabled not offer the non-application based device when you get 2.0 out?

Correct.

Okay. Great. And then the other quick question I've got. So research and development plans are primarily a wind down for the rest of the year. But Brian, do you know for SG&A, how should we think about that line item going forward? It seemed like in the last two quarters, freight it stayed pretty stable. Is that still the plan? Should it maybe raise a little bit with sales continue to grow? What's kind of your expectations there?

Yes. I think you've got to look at it kind of in two buckets. There's the sales and marketing, which has a variable element to it in addition to a fixed element, that will -- that will increase, right, with sales, the variable portion will. However, there is a rationalization of operating expenses that Dan referred to earlier in the call. So we're looking at -- we've reduced some positions in G&A. So I think the G&A fixed part will go down a bit and that will be offset somewhat by the variable cost element of sales and marketing. So it should stay around that number more or less. Obviously, we'd like the variable to go up more and the revenue going up is a good thing, too, right? So that's how you should look at it.

There are no further questions at this time. I'll hand the floor over to Dan Goldberger for closing remarks.

Thank you, operator. We appreciate everybody joining our call today. I want to give a special thanks to all of our employees who work tirelessly to deliver our amazing therapy to patients. I also want to thank the health care professionals and their patients for their loyal support of gammaCore therapy. We are also thankful for the support of AFRL, NIDA the NFLPA for supporting our new product initiatives and research. Lastly, we have to thank our shareholders, new and old, for their ongoing support of the company and our mission to improve health to our proprietary noninvasive vagus nerve stimulation technology platform. To our long-term directors, JP Errico and Trevor Moody for reelection at our shareholder meeting last week and we've reduced the size of the Board from 9 to 7 directors. JP Errico cofounded the company with his uncle, Dr. Tom Errico many years ago. He's the most brilliant and passionate inventor and businessmen I've ever had the pleasure to work with. Trevor Moody has been a Director for many years preceding and through the initial public offering and the difficult transitions that followed. Trevor's strategic insight and advice have been fundamental to the business success that we're starting to report. We're very fortunate that both of these fine executives will continue to be available to us as consultants going forward. Sadly, I want you to know that the electroCore family is mourning the untimely passing last week Stefan Florea, a long-time engineering team member at our Rockaway, New Jersey facility due to his illness. He'll be missed. We've made a lot of progress at electroCore and we couldn't have done it without all of your unwavering support. Thank you all, and have a good evening.

Thank you. This concludes today's conference. All participants may disconnect. Have a good day.