electroCore, Inc.

Greetings and welcome to ElectroCorps' third quarter 2021 earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Rich Cockrell. Thank you, Rich. You may begin.

Thank you all for participating in the Electric Core Earnings Call. Joining me today are Dan Goldberger, Chief Executive Officer, Brian Posner, Chief Financial Officer, and Dr. Peter Stotz, Chief Medical Officer. Earlier today, the company released results for the third quarter ended September 30th, 2021. You can find a copy of the press release on the company's website. Before we begin, I'd like to remind you that during the call, management will be making forward-looking statements within the meaning of the federal securities laws, which are pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements mentioned during this call that are not historical fact should be deemed as forward-looking statements. All forward-looking statements include, without limitation, the examination of operating trends in the company's future financial expectations are based upon current estimates and various assumptions. These statements involve material risk 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 that describes the risk and uncertainties associated with the company's business, please see the company's filings with the Securities Exchange Commission. ElectroCorps disclaims any intention or obligations 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 this live broadcast today, November 4th, 2021. And with that, I'll turn the call over to Dan. Go ahead, Dan.

Thank you, Rich. Hello, everybody, and thank you for joining us today. I'm excited to report that Q3 2021 revenue was a record $1.5 million. Gross margins have expanded to more than 75%, and net cash used in operations decreased to $3.4 million for the third quarter of 2021. For the third quarter of 2021, total revenue of $1.5 million increased approximately 38% from $1.1 million in the third quarter of 2020. Revenue from our government channel increased 46% to $946,000 for the quarter ended September 30, 2021, as compared to $646,000 in the third quarter of 2020. In our VA DOD channel, a total of 96 VA and DOD military treatment facilities have purchased Gamma Corps products through September 30, 2021, as compared to 67 through the third quarter of 2020. Note that there are approximately 1,300 VA healthcare facilities and 475 military hospitals and medical clinics, so we still have plenty of growth ahead of us. Revenue from direct channels outside the United States increased 33% to $371,000 in the third quarter of 2021, as compared to $278,000 during the third quarter of 2020. We look forward to continued revenue growth in the United Kingdom as the MedTech funding mandate continues to roll out in spite of pandemic headwinds. Turning to our commercial headache channels in the United States, pharmacy benefit managers, including CVS Caremark and Express Scripts, provide GammaCore therapy to patients that have a high-end benefit design that does not differentiate between drugs and devices. These patients are subject to a copay of between $25 and $75 per month depending on their specific benefit plan. Our unique Level 2 Healthcare Common Procedure Coding Systems, or HCPCS code, K1020 Noninvasive Vagus Nerve Stimulator, became effective April 1, 2021. This is an important milestone in our efforts to obtain reliable insurance coverage for gamma-core therapy. Previously, all of our prescriptions were coded as miscellaneous. which made for an easy initial coverage denial for an insurance company. On August 4, 2021, we announced the release of an article entitled Gamma-Core for Cluster Headaches in the journal Pharmaco-Economics, highlighting the cost savings of Gamma-Core's non-invasive vagus nerve stimulation therapy platform for patients with cluster headaches. The paper validated that Gamma-Core both reduces the frequency and severity of cluster headaches and provides 450 British pounds per patient cost dominance and cost savings in the first year of therapy versus standard of care alone. Subsequent to the end of the quarter on October 2021, we announced the publication of a peer-reviewed paper entitled Non-Invasive Vagus Nerve Stimulation for Treatment of Cluster Headache, a Retrospective Review of Prescribing in England in the British Journal of Healthcare Management. The study is one of the largest clinical audits of patients with cluster headaches and highlights that of the 655 patients who started on GammaCore, 46.3% of patients were prescribed at least one refill and 30.9% were prescribed two or more refills. These real-world results suggest a durable benefit for patients utilizing GammaCore's non-invasive vagus nerve stimulation for cluster headache in England. These two publications add to our growing bibliography of positive healthcare economics evidence, which is very powerful in our conversations with private insurance companies in the United States and distributor prospects around the world. Armed with our unique code and recent publications, we are ramping up discussions with insurers. We've engaged a policy reporter to help us negotiate with an initial group of 30 regional and national benefit providers. I marked Blue Cross Blue Shield was our first positive benefit determination, and we're now negotiating their fee schedule. We subsequently want our second positive benefit determination from Blue Cross Blue Shield of North Dakota. While we work towards broader insurance coverage, note that more and more Americans have high deductible insurance plans, which means that patients are likely to be faced with a cash pay obligation even when coverage is available. To fill that gap, we've been aggressively testing several cash pay business models and direct-to-consumer promotions. Net revenue from the U.S. commercial headache channel was $158,000 for the third quarter of 2021, as compared to $112,000 in the third quarter of 2020. Approximately $124,000 of our U.S. commercial revenue in the third quarter came from cash pay programs, specialty pharmacy, and direct from ElectroCorps. and the balance was paid by insurers through the pharmacy benefit managers. Going forward, our U.S. sales function is focused on the following revenue growth initiatives. First, going deeper into our 96 existing VA hospital customers, leveraging our VA hospital success to open new VA hospital customers, and recruiting additional commercial prescribers to our cash pay business models while we work towards broader commercial insurance coverage. We've grown our U.S. sales function in recent months through a combination of our inside customer experience team, territory business managers, and sales agents in the field. I look forward to reporting accelerating growth in our U.S. channels as our team becomes more productive in coming months. As the number of commercial prescribers offering our cash pay alternatives increases, we will also evaluate direct-to-consumer marketing investments to drive revenue growth in future quarters. At this point, I'm going to ask our Chief Medical Officer, Dr. Peter Stotz, to provide an update on our various research and clinical initiatives. Peter?

Thanks, Dan. We continue to advance NVMS across several trials in our FDA-cleared indications, as well as in our intellectual property throughout this quarter. On August 10, 2021, we announced the publication of a peer-reviewed manuscript transcutaneous cervical vagal nerve stimulation in patients with post-traumatic stress disorder, or PTSD, a pilot study of effects on PTSD symptoms, and interleukin-6 response to stress in the Journal of Affective Disorders Reports. The manuscript reports the results of a randomized, double-blind, sham-controlled study conducted at Georgia Institute of Technology and Emory University. The results confirmed previous animal and human signals and show that three months of treatment with NVMS lead to a 31% reduction in PTSD symptoms compared to sham on the PTSD checklist or PCL, as well as a significant decrease in hyperarousal symptoms and a decrease in overall and somatic or gastric symptoms. At the conclusion of the study, Patients who continued to use NVNS for a further three-month open-label period showed a significant improvement in their overall symptoms reported by the Clinical Global Index. Furthermore, NVNS effectively blocked the increase in the levels of inflammatory cytokine, or IL-6, that is overexpressed in patients with PTSD who are exposed to traumatic scripts. PTSD is prevalent in our veterans, represents a high unmet medical need, and is highly relevant in the migraine population in the VA and Department of Defense. In September of 2021, we announced the company received Section 510K clearance from the United States Food and Drug Administration, or FDA, of the company's submission to expand the label of GammaCore and VNS to include the treatment of paroxysmal hemicrania, and hemicrania continua in adults. Paroxysmal hemicrania and hemicrania continua are both rare forms of trigeminal autonomic cephalosis that are typically debilitating and difficult to treat. GammaCore NVMS now has five distinct FDA clearances in primary headache, more than any other headache therapy we are aware of. Subsequent to the end of the quarter, on October 14th, we announced the publication of an amended medical device license from Health Canada to expand the label of Gamma-Core NVNS to include the acute and preventive treatment of migraines in adolescents between 12 and 17 years of age. In addition to our ongoing clinical and regulatory activities, we have been investing in our intellectual property portfolio. In September of 2021, we announced the United States Patent and Trademark Office has issued patent number 11-097-102, relating to devices, systems, and methods integrated with smartphones that allow patients to self-treat medical conditions, such as migraine headache, by electrical non-invasive stimulation of nerves. The 102 patent is the eighth U.S. patent issued to ElectriCorps and the company's mobile connectivity platform, with additional U.S. and international matters pending. ElectriCorps is building a portfolio of intellectual property IP around small, around smartphone connected non-invasive therapy. This IP may provide a foundation for combining the company's clinically proven therapy with digital health platforms that could enable healthcare providers to use remote patient monitoring or remote therapeutic monitoring reimbursement codes. That combination in turn may enable future business models and expand revenue streams for the company's products. At this point, I'll turn the call over to Brian for a review of our financials and other guidance items. Brian?

Thank you, Peter. With the quarter ended September 30th, 2021, ElectroCorps reported net sales of $1.5 million compared to $1.3 million in the second quarter of 2021. and $1.1 million during the same period of 2020. This represents a quarterly revenue increase of 17% sequentially and 38% over the same period last year. Gross profit for the third quarter of 2021 was $1.1 million as compared to $895,000 for the second quarter of 2021 and $733,000 for the third quarter of 2020. Gross margin for the third quarter of 2021 was 76%, compared to 71% in the second quarter of 2021 and 68% in the third quarter of 2020. The increase in gross margin was largely due to increased sales, resulting in a more favorable absorption of labor and overhead costs and product mix. Total operating expenses in the third quarter of 2021 were approximately $5.1 million, a reduction of approximately $1 million from $6.1 million in the second quarter of 2021. Operating expenses decreased by $100,000 from $5.2 million in the third quarter of 2020. Research and development expense in the third quarter of 2021 was $470,000, as compared to $825,000 in the second quarter of 2021, a decrease of approximately $355,000, sequential. The decrease in R&D expense during the quarter was due to timing of expenses in connection with the GAAP PTH program. R&D expense decreased by $159,000 from $629,000 during the third quarter of 2020. SG&A expense in the third quarter of 2021 was $4.6 million as compared to $5.3 million in the second quarter of 2021 and consistent with the year-ago period. GAAP net loss in the third quarter of 2021 was $4 million compared to a GAAP net loss of $2.9 million in the second quarter of 2021. Gap net loss decreased by 11% or $500,000 as compared to a gap net loss of $4.5 million in the third quarter of 2020. In the second quarter of 2021, the company recorded a total gain of $2.3 million on the extinguishment of debt and a tax benefit from the sale of New Jersey NOL carry forwards. Adjusted EBITDA net loss in the third quarter of 2021 was $3.1 million as compared to $4.1 million during the second quarter of 2021, and as compared to adjusted EBITDA net loss of $3.3 million in the third quarter of 2020. The company defines adjusted EBITDA net loss as gap net loss, excluding depreciation and amortization, stock compensation expense, restructuring and other severance-related charges, legal fees associated with stockholders' litigation, total other income and expense, extinguishment of debt, and the provision and benefit from income taxes. A reconciliation of GAAP net loss to non-GAAP adjusted EBITDA net loss has been provided in the financial statement tables included in the press release we issued earlier this afternoon. Net cash used in operating activities during the quarter ended September 30th, 2021 was approximately $3.4 million as compared to $3.2 million in the second quarter of 2021 and $4.1 million in the third quarter of 2020. The second quarter of 2021 amount is exclusive of cash proceeds from the sale of NOL carry forwards. Cash cash equivalents and marketable securities at September 30, 2021, totaled approximately $39 million, as compared to approximately $23.7 million at June 30, 2021. During the third quarter, the company raised net proceeds of approximately $18.8 million through a public offering of 20,700,000 shares of its common stock. And now I'll turn the call back over to Dan.

Thanks, Brian. We're pleased with our operating results this quarter, and we're in a strong financial position with cash and cash equivalents of $39 million as of September 30th, 2021. The recent publication in Pharmacoeconomics confirming cost dominance of 450 British pounds per patient when Gamma-Core therapy is used provides further support to our payer and distributor negotiations. Longer term clinical indications beyond cluster and migraine headache supported by the ongoing clinical developments that Dr. Stotz discussed could greatly expand the market for NBNS therapy. We continue to build our intellectual property portfolio, and we're planning some very exciting next generation product platforms to leverage that asset. For the current quarter that ends December 31st, 2021, We expect revenue to exceed $1.5 million. Our VA DOD channel slowed in the first two weeks of October as those hospital customers worked through their September 30th year-end accounting, and our UK business was impacted by COVID during the month of October. Both channels have seen a return to growth in recent weeks, giving us confidence in our revenue projection and the sales momentum we will carry into next year. For the year ending December 31, 2021, the company expects net revenue to exceed $5,450,000, a 55% or more increase from $3.5 million of revenue in 2020. We currently expect to end the year with approximately $34.5 million in cash, indicating that operations will require approximately $4.5 million of cash during the fourth quarter of 2021. We believe that our cash balance will allow us to execute our operating plan through next year and beyond. Mike Romanu and his operations team have driven gross margins to 76% in the quarter ended September 30th, a healthy increase from earlier this year. Brian Posner's finance team has maintained discipline around operating expenses and I have faith in their continued vigilance as we make targeted investments in the commercial channels and product development. We look forward to further penetrating our large opportunity in the VA DOD channel in the United States under Mitch Deshaun's capable leadership, while Ian Strickland is leading the growth of our international businesses through the continued rollout of the MedTech funding mandate in the United Kingdom and our growing group of distributors in other countries. As we look towards 2022, I see many growth drivers, including continued penetration of our VA DOD channel in the United States, continued penetration of the UK market as the pandemic hopefully recedes once and for all, growth in our U.S. commercial channel, driven at first by cash pay business models and bolstered by our efforts to gain insurance coverage, and expansion of our international distributor network. I want to recognize our dedicated staff for their hard work and commitment in these trying times and thank the healthcare professionals and their patients for their loyal support of gamma core therapy. At this point, I'll ask the operator to open the line for questions.

Thank you. We'll now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Thank you. Our first question is from Jeffrey Cohen with Leidenberg Thalmann. Please proceed with your question.

Oh, hi, Dan, Brian, and Dr. Statz. How are you? Fine, thank you. Great. So a few from our side. So firstly, Dan, can you talk about the VA and DOD channels as far as any type of predictability and how you're seeing trends formed both at new facilities coming on as well as existing facilities?

Yeah, sure. The first thing is that There is a little bit of seasonality in that channel just around the September 30th year end. They pull a little bit of business forward into September, and then there's about two quiet weeks in the beginning of October while they finish up their accounting. That's a pattern that we've seen previously. Over the course of the summer, we rebuilt our field sales function under Mitch's leadership. And that new group of folks has been in for training now, and they're out now in the streets detailing the existing customers and starting to prospect for new VA hospitals. And we leverage that capability with our inside sales, the customer experience team that Lisa Martin runs. And also, look, the pandemic once and for all seems to be receding. I think hope springs eternal, but we're starting to see things accelerate just in the last few weeks and looking forward to great things in coming months.

Okay, got it. And could you talk about Europe a bit as far as your commentary about growing distributors and maybe talk about are there any reimbursement processes going on for any CE countries?

Yeah, so on that last point, you know, we've got tremendous success in the UK and support from NHS and their healthcare economics arm, NICE. Wales is likely to come on towards the end of this year, but that may slide into next year. Brexit has been a little bit of a headwind because we run the rest of Europe through our UK subsidiary. There are various countries around Europe where we are working through the national healthcare system to try and drive additional reimbursement in different territories. And all of that just makes us much more attractive as a distribution partner for the independent distributors. So again, we had a pretty good cadence of announcing distributor wins. throughout 2021 and looking forward to continuing that as well as generating repeat business in 2022. Okay, got it.

And then lastly for me is for Dr. Statz. You talked about this PTSD pilot study. Could you talk a little bit about the size of that study as far as the powering? And then perhaps you could comment on Has there been any commentary, any measurements out there as far as anyone looking at depression?

Sure. It's a long and complicated set of questions, but I'll dive in. The study itself was a relatively small study. It started with 20 patients randomized to receive either sham or active therapy. And what they had data on was eight and eight. And it was a sham device versus an active device. And they were able to really show a statistical difference in a variety of metrics looking at this. And one of the things that's exciting to me is it's not just a psychological response, but it's actual measurements of interleukin-6, which is an inflammatory cytokine that frankly was associated with high mortality in the patients with COVID. So it's a, this is a real pro-inflammatory cytokine that was able to be shown to be altered. This study, of course, is not going to be enough in and of itself for an FDA clearance, etc. But the scope of the problem out there in our veterans is really quite high. The scope of the disease is out there, you know, it's probably close to 3% in some capacity, not in the non-veteran population. So this is a big, unmet medical need. The signal was very strong, however, and I think it will lead us to the next set of studies as we're processing this and what needs to be done next for a true FDA study and filing.

Would you expect in the case of PTSD for the agency to want or for you to want to do some imaging? And then I'm sorry to cut you off from my depression question.

Oh, sure. No, you didn't cut me off. I segue. So we have had imaging studies done over the years. There have been a number of functional type of imaging studies that have been done demonstrating an improvement in brain activity as well. So those are what we just talked about was kind of an additional to data that's already been done. And, you know, a brief search of NVNS and PTSD will show a number of papers out there on Google Scholar or the NIH website, et cetera. So you can find a lot of stuff that, in fact, already has been done that are supportive of this. Now, the second question about depression is not an area that we have decided to invest in today. But I would just, you know, mention that the implanted vagus nerve stimulator, originally Cyberonics, received an fda approval for anxiety depression back in 2005 and i personally am of the belief that things that other vns strategies have shown are really in our domain of being able to do similar types of demonstration of clinical activity as well so uh long and short of it is we are not at this moment looking at a depression indication, but it's in the realm of possibility.

Perfect. Thanks for taking my questions.

Sure. Thank you.

Thank you. Our next question comes from R.K. with H.C. Wainwright. Please proceed with your question.

Thank you. Good afternoon, Dan and Brian. On the cash pay sales revenue lines, what has been your experience to date in terms of penetration? And also, from your experience, how motivated are patients to pay to treat their symptoms, especially when they don't get too much reimbursement? from their insurances?

So thanks for the question RK. We currently have, we started this last summer and we currently have 50 plus prescribers around the country enrolled in one of these cash pay pilot programs and we've been very upside surprised that something like 65 or 70% of the patients that get a prescription written do ultimately pay that out-of-pocket cash price when it's highly recommended by their physician. I'd love to be able to say that we're going to be able to maintain that high conversion ratio, But right now we're off to a very exciting start.

Perfect. That's pretty good. And then for the VA stream, you know, you currently have, you know, interactions with about 96 centers as of the third quarter, steady growth, of course, with the number of centers that you're interacting with. As you said, with the COVID, You know, what's the benefit or what are your thoughts on trying to do a big bolus of resources so that 2022, you know, gets to a good start, especially in the biggest revenue channel that you have?

So, you know, we are looking at various scenarios, investment level scenarios for 2022. We rebuilt our sales function with Mitch Deshaun joining us last spring, and he put together his team over the summer and trained them. So we're going to start to see some of that investment in the current quarter, in the December 31st quarter, but really demonstrate the productivity of that combination of a field sales function and our inside sales function in the first half of next year. If that goes, if we can demonstrate the productivity of our initial team in the first half of next year, you know, absolutely we'll be coming back to the board to say, okay, we want to ramp up our investment in the sales function to drive more accelerated growth in 2022.

Okay. My last question is on the UOK channel. It being kind of flat, flattish for the current quarter, you know, what should we think for that channel during the next couple months left in 21 and also into 22. And in that same way, when we look at other geographies outside of UK, is there one or two geographies in your mind that you think will become meaningful, let's say in the next 12 to 18 months?

So COVID has been a bigger challenge in the UK and in Europe than it has been in the US. And it's actually been kind of personal. We have a small team in the UK and two of our employees in the UK had actually came down with COVID in September and October. But they're healthy again, but it's a big impact on our activities. So We're going to be a little bit slower recovering in the current quarter. That said, all of the mechanics for growing the UK business at that sort of 10% sequentially as the MedTech funding mandate rolls out are in place. And so we should see that return to growth as we roll into next year and the pandemic does whatever it does and and get back to that steady growth with support from NHS in the United Kingdom. Outside, you know, I think Canada and Australia are very likely to start to accelerate as we roll into 2022. And it's still a little bit too early to tell what our European distributors are going to be able to do between the challenges of Brexit and the pandemic.

Okay. Fantastic. Thank you for taking all my questions. Absolutely.

Thanks for the opportunity. Thank you. As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. The confirmation tone will indicate that your line is in the question queue. Our next question comes from John Vandermosten with ZACS. Please proceed with your question.

Hey, thank you and good afternoon. I also had a question on the VA and trends there. When you look at, and congratulations on the nice increase in facilities that you're serving, when you look at older facilities and newer ones and think of it in terms of like a same store sales or comp basis, do the older ones kind of maintain you know, steady growth or are they flat? You know, I'm just trying to get a sense of how those are. So when we continue to layer these on, you know, how it should affect our forecast there for revenues.

Yeah, it's a good question, John, and it's distorted by the pandemic. So I don't completely trust our trailing actual numbers. In general, the business is quite sticky once we have a a prescriber who has had success with the therapy. They keep coming back. But as the pandemic has come and gone and the VA hospitals in different cities have had to focus on pandemic response or doing vaccines, right now there's some disruption around doing booster shots. I don't trust the patterns that we see for the last year and a half.

Okay. Yeah, right. There's been a lot of disruption, definitely. Okay. I guess we'll have to wait until another year passes, and then we'll kind of see how those pan out. Gross margin was another bright spot that I wanted to ask about. You had a gross margin that's higher than our long-term estimates there. Should we think about changing our estimates and moving them up a bit? Brian, it sounded like from what you were saying that these were sustainable types of improvements. Is that kind of what you see, or are there some issues in there that may bring those down a little bit in the future?

Yeah. In the short term, it really depends on labor and overhead absorption, which is obviously dependent on revenue and product mix as well. In the long term, though, we're confident that we will sustain very strong gross margins.

Okay, great. So it sounds like it wouldn't be a problem to kind of bring them up maybe longer term to this level that you achieved in the third quarter.

That's a fair assessment.

Okay, great. That's good news. And then the other question kind of follows up on one of the other analyst questions about the distributors and how they're trending. So if you look at each of them and try to think of them in a category of – you know, preparing to make sales or, you know, almost making sales or kind of making sales. Can you clarify that a bit for each? It sounded like kind of you mentioned a little bit about Canada and Australia and Europe, but I was wondering if there's any more clarity on kind of where each of them are in terms of, you know, getting sales going. And it looks like some of them have already added a product and they have it ready to go. It's just, yeah, I just wanted to get a sense of kind of where it was.

Yeah, so just to reiterate, Canada and Australia are the furthest along in their making. They're selling through their inventory and coming back for replenishment. We've had success with certain prescribers in Europe, but it's too hard to read through It's too hard to determine patterns again between the disruption of Brexit and the waxing and waning pandemic nonsense. So, you know, I wish I could be more granular, but not yet.

Okay. Okay. And then last one for me is on the cash pay. Just a basic question on, you know, is there any difference in pricing between the cash pay and what an insurer would pay if they were fully covered and did not have a high-deductible health care plan?

Yeah, we've been doing quite a bit of price discovery with our pilot activities through the beginning, through the first half of this year. And so... and we're going to continue to fine-tune that price discovery. So, yes, it's different, but I'd like to leave it at that, if you'll allow me.

All right. Thank you, Dan, Brian, Dr. Stotz. Always a pleasure to talk to you guys. Thank you. Thank you.

Thanks, John. Thank you. There are no further questions at this time. I would like to turn the floor back over to management for any closing comments.

Thank you, Operator, and greatly appreciate everybody's time and attention. And also, I'd be remiss if I didn't point out Veterans Day next week, given the strong support that we have in the VA hospitals and the DOD military treatment facilities. So stay healthy, everybody.

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.