And welcome to the electroCore First Quarter 2023 Earnings Call. [Operator Instructions]. As a reminder, this conference is being recorded. It’s now my pleasure to introduce your host, Nicole Jones, investor Relations. Please go ahead..

Thank you all for participating in today’s electroCore earnings call. Joining me today are Dan Goldberger, Chief Executive Officer; and Brian Posner, Chief Financial Officer. Earlier today, electroCore released results for the fourth quarter and full year ended March 31, 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 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 assumptions 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, May 3, 2023. With that, I will turn the call over to Dan.

Thank you, Nicole. Hello everybody, and thank you for joining us on today's call. We are thrilled to report another record revenue Quarter with sales of $2.8 million for the period ended March 31, 2023, a 46% increase over the prior year. Gross margins expanded nicely to 84% for the first quarter of 2023. Our prescription headache business continues to grow worldwide. We launched two new non-prescription product lines in late 2022. Truvaga as a direct-to-consumer wellness brand and TAC-STIM for human performance for our active duty military personnel. Both new products exceeded our expectations in the first quarter and are driving excitement about the future. Truvaga is currently available exclusively through our e-commerce platform@truvaga.com, we are positioning Truvaga as a direct-to-consumer wellness product for stress, mental acuity, and sleep. No prescription is required for this category. Truvaga recorded net sales $147,000 in the first quarter of 2023. Based on this initial success, we are accelerating our marketing investments and raising our internal expectations for the product line. So far this year, our revenue return on advertising spend, what the industry calls a media efficiency ratio or mer has been greater than 2.0. We're carefully monitoring return rates as well, which have been below 10% so far this year. We believe that the Truvaga business can scale nicely if we can maintain or improve these metrics, as we move through the year. TAC-STIM for human performance is being sold to select Air Force and Army Special Forces units for accelerated training, sustained attention, reduced fatigue, and improved mood, without a prescription as defined by the Air Force Research Laboratory or AFRL. We recorded $88,000 of TAC-STIM revenue in the first quarter of 2023, and I'm encouraged by the growing sales funnel for this product. In parallel, we're developing a second…

Thank you, Dan. Where the quarter ended March 31, 2023 electroCore recorded net sales of $2.8 million compared to $1.9 million during the same period of 2022, which represents an approximately 46% increase over the prior year. The increase of $881,000 is due to an increase in net sales across all major channels. Gross profits for the first quarter of 2023 was $2.3 million as compared to $1.5 million for the first quarter of 2022. Gross margin for the first quarter of 2023 was 84% compared to 81% in the first quarter of 2022. Total operating expenses in the first quarter of 2023 were approximately $8.5 million as compared to $7.1 million in the first quarter of 2022. Research and development expense in the first quarter of 2023 was $1.8 million as compared to $934,000 in the first quarter of 2022. This increase was primarily due to targeted investments to support the future iterations of our therapy delivery platform, including the use of our intellectual property around the delivery of smartphone integrated and smartphone connected, Non-Invasive therapy. Selling, general and administrative expense for the first quarter 2023 was $6.7 million as compared to $6.2 million in the first quarter of 2022. The increase was driven by severance charges of $332,000, as well as continued targeted investments in sales and marketing to support our commercial efforts offset by decreases in insurance and stock-based compensation expense. GAAP net loss in the first quarter of 2023 was $5.9 million compared to the $5.6 million net loss in the first quarter of 2022. Adjusted EBITDA net loss in the first quarter of 2023 was $5.1 million as compared to a net loss of $4.6 million in the first quarter of 2022. A reconciliation of GAAP net loss to nine GAAP adjusted EBITDA net loss…

Thank you, Brian. I'm very pleased with our first quarter 2023 operating results, and we are increasingly enthusiastic about the company's long-term prospects, especially in our two new product lines, Truvaga and TAC-STIM. 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 first quarter of 2023. Truvaga has tons of potential as a direct to consumer wellness offering, we've 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. We believe our metrics are trending in the right direction, and we will continue to adjust our in investments 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 incoming 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. Demand for our prescription gammaCore therapy and the VA DoD channel continues to grow based on clinical performance and our increased presence in the field. We now have about 45 straight commissioned sales agents, or 10 99 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 $300,000 from $2.4 million in the first quarter of 2022 to $2.7 million in the first quarter of 2023. While sales grew almost $900,000 signaling that there…

Thank you. [Operator instructions] our first question comes from Jess Cohen with Ladenburg Paulman. Please go ahead.

Hey, this is actually destiny on for Jeff. Thank you for taking our questions. I guess what I'd like to start with is actually the VA and DoD channels. You now have 324, if I heard correctly, facilities and 45 reps.

124.

124. Okay. Got it. Got it, got it. So can you talk a little bit more about the, the growth there and now that you have the 45 reps, how you kind of see it growing throughout the balance of the year and then obviously beyond.

Yep. So, so thanks for the opportunity Destiny. The VA hospitals we have basically two tactics. The first is opening new customers, new VA hospitals that haven't ordered from us before. And the second is taking care of our existing customers and going deeper within those existing customers. Both of those tasks at the end of the day still require feet on the street. We just haven't found a way to get these kinds of hospital based sales without showing up and showing up reliably. And that's where the straight commission sales agents I call them really allow us to the activity. Many of us at the home office, our, our, our medical affairs team, our territory business managers get involved in, in targeting specific new facilities to open up. And then once we have opened them up, we rely on the local sales agents as well as our customer experience team to follow through. And this is one of those areas where success begets success and more and more our sales agents as they're doing better and their network of colleagues who are also in the neighborhood hear about their success. We're, we're looking at some acceleration in our ability to reach new facilities as well as to go deeper within existing facilities. And just to be clear, the sales agents are all variable expense. There's no fixed expense associated with them.

Got it. Okay. Okay. And you said you had 45 reps. Ha has that changed at all? Since last, -- a both

Yeah. That's a -- that's a dramatic increase from, where we were at the end of last year we were just starting to put together our network of 1099 reps as we exited last year.

Perfect. Okay. That's really encouraging. Thank you. And then perhaps I'll go over to TAC-STIM 2.0 as you're calling it. Can you just talk a little bit about some of the advancements you're making or some differences between the TAC-STIM device now and 2.0? And then yeah, well, let's start with that and then I'll have a follow up.

Sure. Of. So so air Force Research Laboratories has been working closely with us to develop a mill speck rugged reliable version of our handheld personal use Truvagas nurse stimulator. And we, I actually had the, the, the great pleasure showing some prototypes to special courses operators at hold field in, in Florida just last week. And they're getting very excited about this next generation configuration because it's going to be far more useful to them in the field. So as far as timing we're, we're going to have to stay quiet about the, the timing for when that product is going to launch, but we're very excited about it. And, and maybe more importantly the special forces operators are, are excited about it.

Absolutely. Okay, great. Thank you. And then I want to bounce over to Truvaga. I was wondering if you could talk a little bit about your demographic data there, given that this is an,kind of an over the counter type product that's pretty readily available. Are you seeing a huge change or difference in demographic between your gamma and the Truvaga?

So most of our U.S. gammaCore sales are through the VA hospital system, and that's a very different demographic. But on our, on the commercial side I think the demographic skews younger and is closer. But still the, the Truvaga personas that we're currently targeting with our media spend and our, and our, spend, our internet search and social media spend is younger and more affluent. But it's, it's really small numbers at this point, and I, I don't want to draw too many conclusions from what are really small numbers by in the grant scheme of things.

Okay. Got it. And then Brian, I just have a couple for you. The gross margin expansion, is this kind of a level we should expect to see going forward? And the driver is volume or channels or both? Yeah, I guess let's start with that. I get ahead of myself.

Yeah. No, that's okay. I'll try to keep up with you. No, we've been consistently in the eighties for the past year, we had some cleanup on the balance sheet in q4, so we were down to 75%, but without that cleanup we would've been in right around where we finished q1. So I think that'sfor, for right now that in the eighties is a safe place to assume I think it's a combination of increased revenue, that, that way we absorb more labor and overhead. We continue to also sell more and more longer duration products, which also is acc creative to gross margin as well.

Okay. Got it. Thank you. And then last one, I promise, in terms of a greater investment in marketing, what kind of investment are you looking at maybe on a percentage basis going forward?

Yeah, so I, I talked a little bit about the growth in our sales and marketing expense compared to the growth in revenue and back to the envelope our, our sales and marketing expense grew at sort of less than 30% of revenue. So I think that might be a good way to think about how we're going to be reinvesting in sales and marketing to grow that revenue line.

Okay. Perfect. Well, that does it for me. Thank you for taking my many questions. I'll hop back in queue.

Next question comes from John Vandermosten, Zacks SCR. Please go ahead.

Alright, thank you. And hello, Dan and Brian. You guys have had a lot of how you doing a lot of great press releases on just the, the wide profile of, the device andwhat it can do. And,language learning is just something else that I haven't even thought about. But,in, in, in our research,we've seen a lot of other areas that you've talked about also as well, and you,it, it seems to have a safety profile on kind of the benefits of exercise, right? But without the effort and, and you also have opened up a channel that and doesn't rely on, rely on the FDA to distribute the product. And I'm wondering,how can you leverage that and also get more eyes on the product and what it can doto really leverage that Truvaga you know channel that you have?

Well, we're, this is early days for us, John, but you're, you're absolutely right, right? We're, if we do this correctly the direct to consumer wellness for stress, for mental acuity, for sleep is going to draw attention to the, the fundamental benefits of vagus nerve stimulation and, and should have carryover to our prescription strength gammaCore brand and vice versa. And then all of the work the really exciting work that Army Special Forces and Air Force Special Forces are doing that I can't talk about yet. And I'm really looking forward to the day that we can start a campaign that's, for example, as used by Army Special Forces. So all three brands, if we do this correctly, are going to reinforce and build on each other. The other, yet another opportunity for us, and, and we haven't talked about it too much yet is the relatively young Truvagas nerve society. It's a, a professional academic society, which is really focused on all of the benefits and method of operation of the vagus nervestarting from holistic approaches, including implants and of course non-invasive and minimally invasive approaches. But that that society is becoming a forum for broad-based discussion by healthcare professionals, by neuroscientists and, and ultimately I think by the lay public as well.

Okay. And we, as we're still in the early stages of Truvaga, with very, very low revenues relative to some of, some of your other businesses. But I guess, do you prefer, on a margin basis, do you prefer a dollar revenues from to Truvaga or, the VA kind of NHS source?

You know, all of these, all three of the, of the brands right now are in that low, 80% gross margins. So they all help each other and, and because we're still a very small business revenue in general helps us spread the, the fixed expenses of the company, the public, public company expense, rents, insurance.

So, it sounds -- it sounds like Truvaga right now is kind of on par with the other one as it grows, the, the, the attractiveness might increase, just leveraging kind of the fixed efforts. Yeah?

Absolutely. Truvaga, absolutely. Yeah.

Okay. Yeah, yeah, no, that's really helpful. And, and wanted to look at the NIDA grant. How is that going to flow through your income statement? You mentioned it was a three year study…

It's well, that…

oh, I'm sorry, Dan,…

The, the IDA grant is to Emory University and the VA, the Atlanta VA Hospital, all of that money is, is going to those entities to execute the Pivotal trial. So maybe the right way to think about it is it's a, it's an expense offset because that Pivotal trial will become the foundation of a five 10 K [ph] submission and ultimately a label extension to treat the symptoms of withdrawal from opioid use. So it's money that we don't have to spend in order to get that additional indication in the future.

Okay. And you, you, it was a three year study. What, what was the start date on that, or anticipated The start date?

So the, the trial will start in coming months. We're optimistic that they will complete enrollment towards the end of 2024 in which case we can ha we can execute on the regulatory process in 2025.

Great. And last thing page, Jim you had a press release announcing that you received the annual license fee from them. Are there any milestones in the near term or median term that we should look out for to help us predict when royalty revenues may come? So…

We're, we're booking license revenues on a quarterly basis and, and they're making quarterly payments. I think what you're really asking is when is it going to turn into product sales? And that's probably over, that's probably still over the planning horizon there. Our good friends at [indiscernible] are working with the Japanese Ministry of Health. They're lobbying hard to get the Ministry of Health to accept the pivotal data that was collected in the United States, but that's, there's still a high likelihood that they're going to be forced to conduct at least a small in-country pivotal trial, which is going to chew up calendar time.

Got it. All right. Dan, thank you so much. And Brian, thank you as well.

Thanks, John. John, appreciate your support.

Next question comes from Ramakanth Swayampakula with H.C. Wainwright. Please go ahead.

Thank you. Good afternoon. Dan and Brian, this is obviously we have discussed quite a few, quite a few interesting pieces of the company. A couple of things that I would like to understand a little bit more is so on the, on the commercial business, you know I believe you stated that there are about 1,834 prescribers are approximately five and six new additions, which is quite a, quite a decent number in terms of prescribers added. How, how does that translate to revenue? And, you said you're kind of, thinking of them as a lead in indicator. So I'm just trying to understand like, how, how do you, how, how are you coming to that conclusion and, and when you say lead-in, what is the lag time we are thinking of from them coming on board, to getting scripts to return on a regular basis?

Yeah, so, so those that, that cohort of 500 that we engaged in the first quarter our metric is that they that we filled at least one prescription in order for that prescriber to be counted as a new prescriber. So they're already generating revenue. And there are two metrics there. The first is how many of those are new prescriptions And then how many are refill prescriptions? So they, to an earlier question, Brian said something about product mix and, and refill prescriptions are higher margin for us, but we need the new prescriptions in order to build the installed base, if you will, of happy patients that are going to come back for refill prescriptions. So there are two ways that this business builds on itself. The first is that once we've engaged a prescriber, if their patients have a good experience they come back and prescribe for more of their patients and, and within their patient population getting getting patients to stay on therapy and come back for refill prescriptions.

Very good. And then, yeah, when you, when you made your statements about John's healthcare you are also suggesting that, this could potentially become something close to what is doing for you with, so for that really to happen what, what needs to get done? I know you, we are just very, very early stages. You just said the first set of prescriptions have been processed in late April. But I'm just trying to understand like, how, how, how would, how would it become meaningful or like how long could that take to become meaningful?

Yeah, so the, the short answer is that we think it's going to be meaningful revenue as we exit this year. As a practical matter these first prescriptions are bumping their way through the Kaiser system first, and then they get to Joerns and neurons has to identify the particular patient, figure out which benefit plan they're on, figure out where they are, where that individual is with respect to co-pays and deductibles. It's called adjudicating the prescription. And then they have to collect that copay from the patient before we can dispense to the patient. And so each one of those steps has to be sorted out in the bureaucracy, but once it's sorted out, it should start to become far more systematic and scalable. And so as the as the bureaucracy starts to work smoothly we're going to take our same field sales force that's calling on the VA hospitals to start calling on the Kaiser facilities to engage prescribers to scale that business. And it's got a lot of the same characteristics as the VA hospital business. So I'm very optimistic that it's always, it's going to take longer than I want, but I'm optimistic that as we roll into 2024 fundamentally we'll have access to another 10 million covered lives.

Very good. Then this is a kind of a two-part question. So when we think about Umcor Truvaga taxed him, TAC-STIM 2.0 how, how, what is the, what is the margin contribution from, you know is, is the margin contribution different from each one of these things? And then also in terms of the, the pricing how different is it for these for, for each one of these?

So it, it, it's a very good question. And the numbers for our new brands are, are still very small. So the, the margin profile is going to evolve. The Truvaga product that we're currently selling is on the internet for $300 for a first transaction. So that, that's kind of the price point. The TAC-STIM is you know, is right now is very limited distribution to certain units of special forces. And, and each one of those transactions has its own pricing profile. So right now it's, it's, it's not, not that it's complicated, but we're not sharing very much pricing information publicly, un until these lines of business it substantially larger.

Okay. So the last question from me is, again, from among these four devices, right? Or brand, brand line, or lines of uhor. Is the, is the technology any different or it's all the same except that it's packaged differently for different uses?

So the way that I like to describe it is that GammaCore is our prescription strength product offering. Truvaga is our direct to consumer wellness product and, and has the same, exactly the same safety profile but is not as energetic as the prescription strength. You know you know, we may have talked about it, but I can go to the corner store and get 200 milligrams of ibuprofen under the Advil brand pretty much any, any store you want to. But I can also go to my doctor or dentist and get a prescription for Motrin, which is 800 milligrams of ibuprofen. So there's, there's prescription strength, ibuprofen, and then there's the direct to consumer over the counter strength. And that's, that's how we're trying, that's how we differentiate those product lines.

Okay. So truer is not going to teach me a different language, or it'll have a tougher time.

No, No,

Okay. Thank You.

Although there, there is evidence that, that there is evidence that it helps mental acuity, but you're pretty sharp. You don't need it.

Thank you. Thanks for taking my questions.

Next question comes from Kemp Dolliver with Brookline Capital Markets. Please go ahead.

Hi, thank you and Good afternoon. Just a couple of questions. When you talk about r and d spend tapering from Q1 S level, I mean, how much of a reduction should we think about?

Yeah, we're Oh, go ahead Dan.

Go ahead Brian. Go ahead. No, go ahead, Brian. No, I got it. Yeah,

So we were about 1,000,008 this quarter. I don't think we're gonna give specific, you know, dollar guidance on the call, but it, we expect by the end of the, the year that that number will go down significantly.

Okay. Dan, were you gonna give away the goods?

Nope. I was gonna be even vaguer than him, than Brian.

Okay. All right. Fair Enough.

He wasn't gonna use the word significantly probably. Yeah,

Fair enough. You know, with regard to Kaiser and JNS where, when you talk about the length of the process currently you know, claim adjudication once you get it set up and, and running is at least in the prescription world's electronic. And I assume with VA, you're, you're pretty well set, but what's the, you know, what's the length of the process you're, you're experiencing currently for claims processing versus what it would look like normally?

Yeah, so the, the goal is that everything is loaded into the computer systems that both Kaiser and Jns, and it's automatic that a a once a prescription is generated in a Kaiser facility it flows through. There is always in this, in this DME world, there's always a lack of turns has to reach out to the individual around collecting deductibles or copays. And that's, that's probably a 30 day step in the process on average. You know, some are much faster depending on the benefit plans, and that's but we have very, very small numbers in that channel right now. So I'm, I'm, I'm really speculating.

Okay. Thank you. And you know, Brian, I was looking at the 10 Q quickly and, you know, there was a pretty significant reduction in the long-term inventory number. And can you, you know, talk about, you know, the dynamic there and you know, when we raised, thank You for noticing. You know, just when are we on track for that to say disappear by early 24? Cuz it, obviously the goal here is to avoid, avoid any write down consequence.

Yeah. yeah, I, it's a great question. I don't think there's a, right now a write down risk you know, but it's more what do we expect to sell that we have an inventory in the next year from the date of the balance sheet? So the good news is the current's going up because one, we're selling, we're selling inventory, and two, we project our revenue to the left, as you can see to our guidance. So eventually we won't have long term inventory, we'll be more traditional, just, it'll be a current asset. But that's good news. The more that goes into current from long term means, we're, we're confident about selling that inventory in the next 12 month period.

And, and look, I'll, I'll pile on that. I think Brian and his team have done a great job of, of monetizing that inventory that we inherited several years ago. Kudos.

Next question comes from Nick Sherwood with Maxim Group. Please go ahead.

Good afternoon, this is Nick Sherwood speaking for Anthony ETT of Maxim Group, LLC. Can you get into a little more detail on what's driving the traffic for the e-commerce platform? Tra Vega? Is that a lot of digital marketing or are you seeing some organic growth just from word of mouth that comes from the the VA channel?

Yeah, so there, there is some organic, there's some early adopter. Most of our spend in the first quarter was around paid search. We've started to open up social media channels and I think we just went live on TikTok. We're, we're starting to learn about influencers and we're doing a lot of ab testing on these different digital marketing techniques. So we're pretty excited. As I said in the script, it, it far exceeded our expectations in the first quarter, and now we're feeling more and more comfortable about increasing the spend and and maintaining that return on advertising, spend ratios, those. So it should scale nicely.

Okay, perfect. And I think that's all the questions that I have. So thank you for your time. Great. Appreciate your interest.

There are no further questions at this time. I would like to turn the four back over to Dan Goldberg for closing comments. Please go ahead.

Oh, thank you operator. And we appreciate everybody joining today's call. Lots of good questions. I hope we were helpful in our answers. I wanna give special thanks to all of our employees and our new cohort of sales agents who are working tirelessly to deliver this amazing therapy to, to patients. I also want to thank the healthcare professionals and their patients, their loyal support of our gammaCore therapy. We greatly appreciate support from Air Force Research Laboratories and the National Institute on Drug Abuse for supporting our new product initiatives and, and label expansions. We've made a tremendous amount of progress and, and would not have been possible without all of you and your unwavering support. So thank you and have a good evening.

The conference has now concluded.