electroCore, Inc.

Teksting av Nicolai Winther Norsk tekst av Nicolai Winther Nå er vi nede. Teksting av Nicolai Winther Greetings, and welcome to ElectraCore 3rd Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press Store 0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Hans Wittstum, with Lifesize 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 Stotts, 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, are examination of the operating trends, and our future financial expectations are based on 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. Electricor 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.

Thanks, 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 30th, 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 Gamma Core 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 EUA, for the use of Gamma Core 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 reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief. Reactive airway disease was among the first areas of research for the company, and prior prospective studies on the use of NVNS to treat asthma symptoms provide strong rationale for this therapy as a COVID treatment. Upon receiving the EUA, we moved quickly to establish multiple access channels for patients to procure the device for $1,250, a substantial discount from the $1,750 list price. It is available by prescription throughout our VA DOD channels, to hospitals directly from the company, and through our specialty pharmacy partner, Premier Specialty Pharmacy, by obtaining a prescription through a patient's healthcare provider, or through a telehealth consult powered by our telehealth partner, Upscript LLC. With Upscript's comprehensive online telehealth platform, a patient can consult with a licensed healthcare provider in real time, and, if the therapy is deemed appropriate, have a GammaCore Sapphire CV prescribed and shipped directly to his or her home. We have set up an online portal for patients to use, www.getgammacore.com. We've taken a number of steps to generate awareness of GammaCore Sapphire CV for known or suspected COVID patients, but we're still in the early stages of product launch, and relatively few prescriptions have been written and filled. That said, it is worth noting the media coverage around our EUA has generated an increased interest in GammaCore for headache as well. We've previously announced that two investigator-initiated clinical studies were enrolling patients to evaluate NVNS therapy in hospitalized COVID patients, one in Valencia, Spain, and the other in Pittsburgh, Pennsylvania. These studies, known as SAVIOR-1 and SAVIOR-2, respectively, will measure the safety and efficacy of gamma-core sapphire CV plus standard of care versus standard of care alone in patients hospitalized with COVID-19 across a broad range of clinical and laboratory endpoints. Enrollment in the SAVIOR studies has been slower than anticipated, however, with the increased cases around the world, enrollment trends have recently accelerated. At this point, I'd like to provide an update on key operating metrics and our individual revenue channels. During the third quarter, 2,881 total paid months of therapy were utilized across our three revenue-generating channels, versus 2,407 in the second quarter. The Federal Supply Schedule, or FSS, which encompasses the VA, DOD, and other government and military agencies, continues to be our most important revenue channel. During the third quarter, 68 VA and DOD treatment facilities purchased Gamma Corps, compared to 67 during the second quarter of 2020, and 48 during the third quarter of 2019. Also, During the third quarter of 2020, the company shipped 1,571 paid months of therapy pursuant to VA and DOD originating prescriptions, compared to 988 paid months of therapy in the second quarter of 2020 and 553 during the third quarter of 2019. The 59% sequential increase in paid months of therapy in Q3 is a testament to our team's ability to be nimble and to adapt to a challenging environment that continues to evolve. Revenue from the VA and DOD in the third quarter was $646,000 as compared to $415,000 for the second quarter and $279,000 in the third quarter of 2019. Also related to the VA, in September 2020, we announced that the agency has agreed to sponsor a randomized controlled clinical trial, or RCT, of NVNS in mild traumatic brain injury, or MTBI, and post-traumatic stress disorder, or PTSD. The trial is being sponsored by the Department of Veterans Affairs Office of Research and Development at the Atlanta VA Medical Center, and will be led by Dr. Douglas Bremner, staff physician at the Atlanta Veterans Clinic General Mental Health Unit at the Atlanta VA Medical Center, and professor of psychiatry and behavioral sciences and radiology at the Emory University School of Medicine. Study, which is expected to enroll up to 100 veterans, is designed to assess the clinical and physiological effects of NVNS in patients with MTBI and PTSD. The study's primary outcome measures include assessments of the veterans' clinical improvement, several objective measurements of brain activity, and changes in the levels of the inflammatory cytokine interleukin 6 in response to stress. MTBI and PTSD are significant concerns in the VA, particularly among veterans with both conditions. As we indicated in our September 30 press release announcing the study, it's estimated that up to 56% of MTBI patients have comorbid PTSD, and 18% of veterans of the conflicts in Iraq and Afghanistan present with comorbid MTBI PTSD, making the comorbid condition more common than either disorder alone. There already exists a body of evidence that provide a strong mechanistic and clinical rationale for NVNS as a potential treatment for MTBI and PTSD. Earlier in the quarter, we announced the publication of a paper entitled Noninvasive Vagal Nerve Stimulation Decreases Brain Activity During Trauma Scripts in the journal Brain Stimulation. Dr. Bremner is a co-author of that paper, which reports on a double-blind randomized controlled trial of 19 participants who had experienced trauma but did not have the diagnosis of PTSD, and highlights the ability of NVNS to decrease the fear associated with emotional stress. We are eager to see the results of this study, and we are hopeful that we can make a positive change in the lives of our veterans. To further support our VA and DOD initiatives, we announced the hiring of Commander Sylvester Steele for the newly created role of Vice President and General Manager of our Government Channels Business Unit. As the title implies, this role is responsible for driving continued growth of NVNS therapy within the VA and DoD, as well as developing new revenue opportunities within government channels. Commander Steele brings a wealth of experience creating and leading complex systems and organizations. His background includes more than 20 years in the United States Navy, where he served with distinction in a variety of leadership roles, including as commanding officer or chief executive officer of two warships, the USS Stout and the USS The Sullivans, and as a senior advisor and strategic leader at U.S. Fleet Forces Command and Naval Special Warfare Development Group. Needless to say, Commander Steele has the perfect skill set for this role, and we look forward to his contributions. Turning out of the United Kingdom and other OUS territories, During the third quarter of 2020, Electric Core shipped approximately 1,020 paid months of therapy outside of the United States, as compared to 938 paid months of therapy during the second quarter of 2020, and 828 during the third quarter of 2019. Revenue generated outside the U.S. was $278,000 in the third quarter, as compared to $247,000 in the second quarter of 2020, and $188,000 in the third quarter of 2019. New patient starts continue to be impacted by the COVID pandemic, but we're optimistic that we can sustain growth in both revenue and paid months of therapy in the fourth quarter and entering 2021. Last month, we announced that Gamma Corps would continue to be reimbursed in England under the NHS Innovation and Technology Payment Program, or ITPP, for the treatment of cluster headache in adults for an additional six months through March 2021. The proposed contract includes the option to extend for up to an additional three years through March 31, 2024. The potential contract value if the three-year extension option is exercised could be up to approximately 3.6 million pounds, or approximately $4.7 million, based on the current exchange rate. Since reimbursement commenced under this program in April 2019, we've built a steady base of users, and this extension ensures their continued access to therapy, potentially for an additional three and a half years. More than 55,000 adults in England suffer from cluster headache, a truly debilitating condition with few effective treatment options. Turning to our commercial prescriptions, We previously announced that we successfully restructured our distribution channel by eliminating layers and selling through the inventory that had been placed with distributors during 2019. We recognized a small amount of revenue from specialty pharmacy replenishment in June 2020, and we recognized a full three months of replenishment revenue in the quarter ended September 30, 2020. Commercial replenishment revenue of $112,000 in Q3 was a significant contributor to our strong performance in the quarter. Now that we've cleaned up the channel, the company can once again make investments to grow the commercial prescription business. We started to call on commercial insurers that work through our existing contracts with the pharmacy benefit managers like CVS and Express Scripts with the goal of adding NVNS to benefit plans with more covered lives. In parallel, we are working towards providing a pathway through the medical benefit, including our pending application for a unique HCPCS code. We should have additional information about the CMS process early next year. Moving now to a clinical update, we previously announced that the Premium 2 trial in migraine prevention was closed early due to the pandemic in March 2020. At that time we had 231 patients in the intent-to-treat group and 113 patients in the modified intent-to-treat group. This compares to the original enrollment targets of approximately 400 patients in the intent-to-treat group for a population of approximately 300 in the modified intent-to-treat group. We continue to analyze data from the study and are working to present top-line findings before the end of the year. The company is providing devices and support for several other investigator-initiated trials and a variety of indications. Many of these are having difficulty recruiting patients in the short term as the world manages through the pandemic. These studies allow for the development of novel data and possible additional indications for NVNS without a significant outlay of our financial resources. We will share updates on these programs as they become available. At this point, I'll turn the call over to Brian for review of our financials and other guidance items.

Thanks, Dan. With the quarter ended September 30th, 2020, Electrocor 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 13th, 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 facilities, 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 the U.S. increased 9% to $1,020 in the third quarter of 2020 from $938,000 during the second quarter of 2020. Revenue from outside 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, as compared 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's strategy of significantly reducing its near-term investment in R&D. Gap net loss for the third quarter of 2020 was $4.5 million, compared to a gap net loss of $10.7 million in the third quarter of 2019. Adjusted EBITDA net loss for the third quarter of 2020 was a loss of $3.3 million as compared to an adjusted EBITDA net loss of $8.7 million for the same period in 2019. The company defines adjusted EBITDA net loss as gap net loss, excluding depreciation and amortization, income tax benefit, stock compensation expense, restructuring and other severance-related charges, legal fees associated with stockholders litigation, and total other income and expense. A reconciliation of GAAP net loss to non-GAAP adjusted EBITDA net loss has been provided in the financial statement tables included in our press release this afternoon. Cash and cash equivalents and marketable securities at September 30th, 2020 totaled approximately $26 million dollars. as compared to approximately $24.1 million at December 31st, 2019. Our September 30th, 2020 cash balance includes an additional $11.2 million raised in Q3 through our previously announced stock purchase agreement with Lincoln Park Capital. Net cash used for the quarter ended September 30th, 2020 with approximately $4.1 million. excluding proceeds from sales of stock to Lincoln Park Capital. This represents a decrease of $1.1 million, or 21%, from $5.2 million in the second quarter of this year, and a decrease of $3.5 million, or 46%, from $7.6 million in the third quarter of 2019. The second quarter number excludes cash received from the sale of New Jersey NOLs and financing activities. Looking ahead, for the full year 2020, we expect net revenue to be in the range of $3.3 to $3.5 million, and fourth quarter net cash consumption to be approximately $4 million. And now I'll turn the call back over to Dan. 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 in 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 out over the next 12 months, We're approaching several important data events, including top-line data from the Premium 2 trial, enrollment updates from both Savior trials and 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 for their loyal support of GammaCore therapy. Some of you are aware of the untimely passing of Naftali Tali Zunida. Tali passed away in the early hours of Sunday, October 4th. 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 your question and answer sessions. If you'd like to ask a question, you may press star 1 on your telephone keypad. A confirmation tone will indicate 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 handsets before pressing the star key. Our first question comes from the line of Ryan Zimmerman with BTIG. Please proceed with your question.

Good evening and congrats on all the progress in turning the company around. Dan, maybe if I could start with guidance for a second. You're guiding the 3.4 million at the midpoint. It implies 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 could just help us think through kind of your guidance and what's giving you kind of that apprehension.

Yeah, 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. You know, a large portion of our business runs through the federal supply system. Their year end is September 30th, and so we have a nice... a nice tailwind from the year end 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 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 the November-December holidays and what could possibly happen to our headache business. So, optimistic about upside, but we want to make sure that we give the right number at this point in time.

That's understandable, and appreciate the color there. Just turning to this commercial channel, it's kind of this burgeoning business for you guys, and so, you know, appreciate you've worked through the inventory now, you're starting to call in commercial insurers. What do you think you need to start to get Covered Life 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 the NICE 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 medical economics data. So I continue to be optimistic, but in the short run, the pandemic makes it difficult for us to even have the conversations.

Understood. I'll hop back in here and let some others ask questions. Thank you.

Our next question comes from the line of Dave Turkley with JMP Securities. Please proceed with your question.

Great, thanks. Maybe just to follow up on Ryan, his questions, you know, given that the three businesses were up sequentially last 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 some of the sequential improvements could continue into 2021, maybe even as we work through the year. Any thoughts as you look at the three, why that wouldn't be the case as we try to model out next year?

Yeah, so look, we're 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 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 just 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, you know, obviously OPEC's 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-sized now? Do you have the number of folks that you need to, I guess, continue the momentum that you're seeing in this quarter?

Yeah, so we're very comfortable with where we are on headcount 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 headcount. as we roll into 2021 and as that business starts to scale.

Great, thanks a lot.

Our next question comes from the line of Soyam Pakula Ramakant with HC Wainwright. Please proceed with your question.

Thank you. This is RK from HC Wainwright. Good evening, Dan. I certainly understand you know, the conservative look into the Q4, but at the same time when I look at the 59% increase in paid months of therapy, which is certainly encouraging. So, if you can help us understand what was some of the driving force behind that, and also, you know, what What could help? I'm just trying to understand what are the pushes and pulls for you being a little bit more conservative than what people would have thought. Sure. So look, in the quarter that ended September 30th, we had some pent-up demand coming from the depressed levels of the second quarter. We 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 worked. 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. I see us returning to that 10% sequential growth under the ITP program, and as we negotiate the larger three year, 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, but Brian and I just want to be, I'm 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 among the prescribers.

Very understandable. That's absolutely fine. But as you touched upon 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 the 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 you know we've been told uh 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 gamma-sphere. Are you comfortable with 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 improve the commercialization for that particular indication?

We are monitoring that situation very carefully. You know, Peter Stotts, our chief medical officer, is very active with a variety of investigators. There was an article in Gemma earlier this week talking about the need for additional therapies, both for outpatient and inpatient COVID sufferers. And, you know, 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 CB therapy, but it's still very small numbers at this point.

Okay, so the last question from me is on the commercial payers. 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?

Look, so both Express Scripts and CVS on the pharmacy benefit side make GammaCore therapy available for a reasonable out-of-pocket copay The challenge for us is getting additional covered lives, and that's going to require 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 GammaCorp 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. 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 payers. They're hiding behind the COVID restrictions for the time being. Very frustrating. Got it. Thank you. Talk to you soon.

Very good.

Thank you.

My next question comes from the line of Jeremy Perlman with Maxim Group. Please proceed with your question.

Hi Dan, this is Jeremy. I'm on the next line for Anthony Vanzetti. A couple of questions. Number one, if you could speak about maybe some trends you're seeing as doctors, offices, hospitals. I know we are hearing of resurgence, 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, your VA channel specifically, between your telehealth capabilities and actual in-person visits? Are you starting to see a shift back to more in-person meetings, or is your telehealth still predominantly what's driving the growth?

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

Okay, thank you. Another question, just back to the commercial channel. I know you mentioned on your call, or I'm sorry if I missed it, you said you have a pending application for your unique... Is that for a CMS code? Yeah, for an HCPCS code from CMS. And do you have any sort of timeline for that, or it's too far to...

give any more information? We thought we did. We thought it was on track for a January decision, but there was a vague 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 vague announcement.

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

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

And this last question, I know this is really far off, But the new pending study with the Department of Veteran Affairs, do you think, you know, if that, again, this is far off, if that goes well, a trial, you know, 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 label extensions into all of those indications.

Okay, all right, great. I think you'll hop back in the queue.

As a reminder, it is star one to ask a question. Our next question comes from the line of Ted Yu with Zach Small Cap Research. Please proceed with your question.

Good afternoon. This is Ted Yu from Zach's Small Cap Research. I'm sitting in for John Vandermosten today. Congratulations on a solid quarter. Thank you. Just a couple questions here. You previously explained in the call, and we've touched on it a few times in the... the Q&A, but I just wanted to clarify. So when you expressed that there 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?

Yeah, so thank you for the opportunity to clarify. 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, a patient, to go online with a telehealth platform and get a prescription specifically for gamma-core CV if they don't have a primary care physician. It's also available online uh you know 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 option here um 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?

Right, so 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. Yeah, so...

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. Electrocor had a fantastic September 30th 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.