Greetings, and welcome to the electroCore’s Third Quarter 2020 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Hans Vitzthum, with LifeSci Advisors. Thank you. You may begin.

Thank you, operator. And thank you all for participating in today's call. Joining me are Dan Goldberger, Chief Executive Officer; and Brian Posner, Chief Financial Officer. Dr. Peter Staats, electroCore's Chief Medical Officer, will be available for Q&A. Earlier today, electroCore released results for the quarter ended September 30, 2020. 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 this 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, our examination of operating trends and our future financial expectations 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 differ materially from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description 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, November 12, 2020. And with that, I'll turn the call over to Dan.

Thank you, Hans. Hello, everybody, and thank you for joining us today. We're pleased to report record revenue and ongoing reductions in operating expenses and cash burn for the quarter ended September 30, 2020. Brian will cover the financials in detail, but I wanted to begin with a few highlights. First, we generated total third quarter revenue of approximately $1.1 million, representing an increase of 44% sequentially and 58% over the third quarter of 2019. We're still in the very early stages of commercializing gammaCore non-invasive Vagus Nerve Stimulation therapy, or nVNS and we are pleased to see a renewed ability to grow revenue against a backdrop of COVID-19, demonstrating that we are adapting successfully to the new normal. During the third quarter, we saw a resumption of growth in all three of our primary revenue channels, the Department of Veterans Affairs, commercial prescriptions in the United States and in the United Kingdom. Notably, we were able to achieve these results while continuing to manage our spending and balance sheet aggressively. During the third quarter, we used $4.1 million in cash to fund our operations. We ended the third quarter with cash and cash equivalents of approximately $26 million, which we believe provides substantial runway and resources to support a number of important and potentially value creating milestones. Turning now to an operational update, beginning with our COVID-19 initiatives. Recall that in July, 2020, we announced an FDA emergency use authorization or UA for the use of gammaCore Sapphire™ CV at home or in a healthcare setting for the acute treatment of adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduce airflow and for whom approved drug therapies are not tolerated or provide insufficient symptom relief. Reactive airway disease was among the first…

Thanks, Dan. With the quarter ended September 30, 2020, electroCore reported net sales of $1,081,000 as compared to $753,000 in the second quarter. This represents a sequential increase of 44%. And it's consistent with the guidance that we provided in our October 13, 2020 business update. The increase in revenue compared to the second quarter of 2020 was primarily driven by a rebound in months of therapy shipped to VA facility as well as contributions from our commercial channel and the UK that Dan alluded to earlier. Paid months of therapy shipped to the VA and DoD increased 59% sequentially to 1,571 in the third quarter from 988 during the second quarter of 2020. Revenue from the VA and DoD also increased 56% sequentially to $646,000 in the third quarter from $415,000 in the second quarter. Paid months of therapy shipped outside of the U.S. increased 9% to 1020 in the third quarter 2020 from 938 during the second quarter of 2020. Revenue from outside of the U.S. increased sequentially to $278,000 for the third quarter of 2020 from $247,000 in the second quarter of 2020. Net revenue from the commercial channel was $112,000 for the third quarter of 2020 that’s compare to 60,000 in the second quarter of 2020. Total operating expenses for the third quarter of 2020 were approximately $5.2 million, down approximately 54% compared to $11.2 million in the comparable period in 2019. SG&A expenses declined approximately 43% to $4.6 million in the third quarter of 2020 from approximately $8.1 million for the comparable period in 2019. Research and development expenses decreased by approximately $1.7 million or 74% to $600,000 in the third quarter of 2020 from $2.3 million in the year ago period. This reduction is consistent with the company strategy of significantly reducing its near…

Thanks, Brian. We're pleased with our performance during the quarter, and we achieved all of the milestones that we outlined back in august. These include one, a return to revenue growth in both the DoD and OUS channels, as well as increased revenue contribution from our U.S. commercial channel, two, publication of a peer reviewed manuscript, exploring nVNS and new indications such as PTSD and traumatic brain injury. And three, the launch of gammaCore Sapphire CV for known or suspected COVID-19 patients. Looking at over the next 12 months, we're approaching several important data events, including top line data from the Premium II trial, enrollment updates from both SAVIOR trials in COVID-19 patients and top line data from the acute stroke trials progressing in Europe. I also want to point out that our cash balance and runway remain healthy with $26 million on the balance sheet and a substantially reduced burn rate. We believe we have the cash runway to achieve these milestones and more. Finally, I want to recognize our dedicated staff for working steadfastly through all of the pandemic disruptions and to thank the healthcare professionals that prescribe gammaCore and their patients to their loyal support of gammaCore therapy. Some of you were aware of the untimely passing of [indiscernible] passed away in the early hours of Sunday, October 4. He had been a valued member of our Electrocore team since August of 2012. Our thoughts and prayers are with the family and we greatly appreciate the support of the Electrocore community. At this point, I'll ask the operator to open the line for questions.

Thank you. Ladies and gentlemen, we will now be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Ryan Zimmerman with BTIG. Please proceed with your question.

All right. Good evening. Congrats on all the progress turning the company around. Dan, maybe if I could start with guidance for a second, you're guiding the 3.4 million, it's a midpoint, it applies a sequential step down in revenue in the fourth quarter. And I'm just wondering what you're seeing is this COVID-related headwinds. Is it some conservatism maybe you can just help us think through kind of your guidance and what's given you kind of that apprehension?

Yes, it's conservative. We are seeing COVID ramp up around the country – around the world for that matter. And the VA facilities that are the backbone of our business are being impacted, as well as just seasonality. A large portion of our business runs through the federal supply systems their year end September 30. And so significantly we have a nice tailwind from the year end and in the federal system. We don't have a whole lot of experience going through the calendar year end with the holidays. And so Brian and I are want to be conservative. The momentum of the business right now halfway through the quarter is faster than that. But we've got to be realistic about going into November, December holidays and what could possibly happen to our headache business. So optimistic about upside, but we want to make sure that that we give the right number at this point in time.

That's understandable and then appreciate the color there. Just turning to this commercial channel, it's kind of this burgeoning business for you guys. And so, appreciate you've worked through the inventory now and you're starting to call on commercial insurance. What do you think you'd need to start to get covered lives in the commercial channels and what have you heard from the payers that would get them comfortable with paying for the therapy? Thank you.

Again, we need to get back to some normalcy so that the payers will take our meetings. That's a big challenge in the short run. We've got a large and growing database of success in the UK with an ICE publication last December. The sheer number of patients that we've been able to treat successfully in the United Kingdom with good tracking is going to lead to additional medical economics data. Similarly in the United States through our growing headache business in the VA system we're able to track some, some medical economics. So I continue to be optimistic but in short run the pandemic makes it difficult to proceed and have the conversations.

Understood. I'll hop back in queue. Let some others ask questions. Thank you.

Our next question comes from the line of David Turkaly with JMP Securities. Please proceed with your question.

Great. Thanks . Maybe just to follow up on Ryan, his questions, given that the three businesses were up sequentially, understanding some of the challenges of the fourth quarter, but sort of, as we look ahead, I would imagine there's no reason to think that the – some of the sequential improvements could continue into 2021, maybe even as we worked through the year there. Any thoughts as you look at the three, why that wouldn't be the case as we try to model out next year?

Yes, so, look, this is just, we were processing prescriptions every day. If the quarter ended today and we looked at our daily run rate then we'd be doing better than the third quarter. That said, we're going into the Thanksgiving holiday. We're going into the end of year holidays. We just want to be careful that the sheer about what the number of working days are and whether or not there's going to be a drop off in the rate of prescriptions. So Chris trying to be honestly conservative about what could happen at the end of the year, but you're absolutely right. If our current run rate was just extrapolated through the second half of the back half of the quarter, we'll be shouting from the rooftops again.

Got it. And then obviously OpEx a lot lower, and I know you've been working on that. I guess from a headcount standpoint, do you think you're – are you right-size now. Do you have the number of folks that you need to – I guess continue the momentum that you're seeing in this quarter?

Yes, so we're very comfortable with where we are on head count as we roll into 2021. If the revenue growth is where we think it should be, then we'll be looking at additional investments in sales head count as we roll into 2021, and as that business starts to scale.

Great. Thanks a lot.

Our next question comes from the line of Swayampakula Ramakanth with H.C. Wainwright. Please proceed with your question. Thank you.

Thank you. This is RK from H.C. Wainwright. Good evening, Dan.

Hi, RK.

I certainly understand the conservative, look into the Q4, but at the same time, and I'm looking at the 59% increase in paid months of therapy in which is certainly encouraging. So if you can help us understand what was some of the driving force behind that? And also what could help, I'm just trying to understand what are the pushes and pulls for you were being a little bit more conservative than, what people would have taught.

Sure. So, look, in the quarter that ended September 30, we had some pent-up demand coming from the depressed levels of the second quarter, also in the U.S. had some end of the fiscal year activity pulling forward some business just because of the end of the fiscal year and how some of the DoD, but work. The bigger picture pre-pandemic, our VA channel was growing 30% sequentially pretty reliably. And that's, I believe, I feel very strongly that we're going to return. We're going to normalize to that 30% sequential growth in the United Kingdom pre-pandemic. We were growing solidly or rather reliably at 10% sequentially. ICS [ph] returning to that 10% sequential growth under the ITP program. And as we negotiate the larger three years, three and a half year contract with NHS, when that goes into effect in the first half of next year then we should be able to grow – we should be able to accelerate growth in the United Kingdom. So lots of reasons to be excited about our momentum going into 2021 that Brian and I just want to be repeating myself and I apologize, but going into Thanksgiving and the end of the year holidays we're very cognizant that things could slow down just because of the holiday season and the patterns in – among the prescribers.

Very understandable, that's sort of defined. But as you've touched up on the NHS potential here, so what is your confidence, regarding getting that three-year extension from NHS regarding the ITP program?

So we are 100% confident that question, the uncertainty is around timing. It's a relatively new process for NHS and there's the Brexit distraction that's going on there. So, we've been told first quarter of 2021, but again, we want to be sober about what can really happen with that government bureaucracy, with the Brexit situation overhanging.

Okay. And then just to touch upon a little bit on the COVID-19 indication, for gammaCore. Are you comfortable with your current strategy regarding commercialization? And what do you think has been helpful and what else needs to be done so that you can include a commercialization for that particular indication?

So, we are monitoring that situation very carefully. Peter Staats, our Chief Medical Officer, is very active with a variety of investigators. There was an article in EMA earlier this week, talking about the need for additional therapies, both for outpatient and inpatient COVID sufferers and it's a complicated situation on the ground. So sorry, I can't give you more color than that. I think you will see some announcements in coming months about progress using our gammaCore Sapphire CV, but it's still very small numbers at this point.

Okay. So last question from me is on the commercial payors, thanks for the update. But what are your thoughts regarding reimbursement and how does the success in that relate to revenue growth in this channel?

Yes, look, so the both Express Scripts and CVS on the pharmacy benefits side make gammaCore Sapphire therapy available for a reasonable out-of-pocket copay. The challenge for us is getting additional covered lives. And that's going to require a meeting with the national and regional insurers and getting onto a larger number of their benefit plans. There are also some insurers that are directing gammaCore through the medical benefit pathway. And that's great. And the work we're doing with CMS towards getting a unique code will certainly help the medical benefit pathway. But the challenge there as you well know is how patients manage their deductibles and what their actual out-of-pocket is going to be, depending on where they are in the calendar and where they are in the deductibles. So I wish I could give you more specificity than that. But as I mentioned with one of the earlier questions, it's been very difficult to actually have the conversations with the with the payors they're hiding behind the COVID restrictions for the time being, very frustrating.

Yes. No, I’ve got it. Thank you. Thank you for this color. And talk to you soon.

Very good. Thank you.

Our next question comes from the line of Jeremy Pearlman with Maxim Group. Please proceed with your question.

Hi Dan. This is Jeremy I'm on actually on the line for Anthony Vendetti. So a couple of questions. Number one, if you could speak about maybe some trends you are seeing as doctors’ offices, hospitals, I know we are hearing of surgeons, but they have been starting to open, they've been open for the last couple of weeks, months. Have you seen in the VA system, VA channel specifically between your telehealth capabilities and actual in-person visits, have you seen – are you starting to see a shift back to more in-person meetings or is your tele-health still predominantly what's driving the growth?

So, we definitely saw a return to inpatient, in person consults in over the summer in the September 30 quarter. Unfortunately, as you roll into from October into November, that trend appears to have reversed. And as you know you see the same headlines as we do as the individual facilities are responding to more COVID patients to having to re-assign their physicians to the pandemic. So it was going in the right direction and it unfortunately feels like it has reversed again.

Okay. Thank you, Dan. And another question, just back to the commercial channel, I know you mentioned on the earlier call earlier, I'm sorry for missing, you said you have a pending application for unique visit is that for CMS code?

Yes, for an HCPCS code from a CMS.

And is there – do you have any sort of any timeline for that, or it's too far to give any more information?

Yes, we thought we did. We thought it was on track for a January decision, but there was a big, everything is on hold because of COVID announcement about two weeks ago. So we're not sure what the process in CMS is going to be, given that big announcement.

Okay. And then let's say pending, you do get a code, a unique code, what do you think that – what doors did that open up for you?

So that opens up not just the ability to negotiate reimbursement with the regional Medicare payors, as well as dramatically simplifies the coding system for all the other payors that are going to run gammaCore therapy through the medical benefit pathway. So it's a big win for us if and when it happens.

Okay. And then just last question, or this is really far off, but the news, the pending study with the Department of Veterans Affairs, do you think, if that – again, this is far off, if that goes well, the trial it shows positive results, is that going to open up, do you have plans for that to be another revenue channel?

So, absolutely, we are optimistic that we're going to be able to show efficacy in concussion traumatic brain injury and in PTSD, and ultimately get labeled extensions into all of those indications.

Okay. All right. Great. Thank you. I'll hop back into queue.

[Operator Instructions] Our next question comes from the line of Ted Yu with Zacks Small Cap Research. Please proceed with your question

Good afternoon. This is Ted Yu from Zacks Small Cap Research. I’m sitting in for John Vandermosten today. Congratulations on a solid quarter.

Thank you.

And just a couple questions here. So you previously explained in the call and we've touched on it a few times in the Q&A, but I just wanted to clarify. So when you expressed that they were few prescriptions that were written and filled, was that just through, UpScript, or is that kind of expressive of all of the channels for Sapphire CV and the EUA in general?

So yes, thank you for the opportunity to clarify. So, so gammaCore Sapphire CV for known or suspected COVID patients is available by prescription from a healthcare professional through Premier Specialty Pharmacy. The UpScripts platform is a way for a consumer patient to go online with a tele-health platform and get a prescription specifically for gammaCore CV if they don't have a primary care physician. It's also available through hospital channels and certainly it's available through the VA DoD through our established channels there. So lots of different ways to gain access to the therapy.

Okay. Thank you for that clarification. And also kind of an offshoot here, of the sales into the VA, how do you rank the scripts by indication?

Sorry, I'm not sure I understood the question. How do we rank the script?

To rephrase gammaCore Sapphire is indicated for both acute and prophylactic treatment of both migraine and cluster headache. And just curious about what the prescriptions are looking like in terms of numbers, in terms of indications into the VA?

Yes, so actually we have four indications for headache, for gammaCore Sapphire treatment and prevention of cluster headache and treatment and prevention of migraine. We generally don't get visibility on one indication or another. We get a prescription from the prosthetics department of the VA and it won't specify what the condition is, what the specific indication is, or the specific condition of that patient. So, we just don't have visibility.

Okay, great. Thank you very much. That's all for me.

There are no further questions in the queue. I'd like to hand the call back to management for closing remarks.

Great. Thank you everybody for your kind attention. Please be safe and healthy out there as this pandemic ramps up. electroCore had a fantastic September 30 quarter measured both by our financial results as well as advancing on a variety of clinical scientific areas. And we look forward to talking to you again after the new year. Thanks everybody.

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time and have a wonderful day.