electroCore, Inc. (ECOR) 2020 Q4 法說會逐字稿

Greetings, ladies and gentlemen, and welcome to electroCore's Fourth Quarter 2020 Earnings Conference Call and Webcast. (Operator Instructions) Also, a reminder that this conference call is being recorded. At this time, I'd like to turn the call over to your host, Hans Vitzthum of LifeSci Advisors. Please go ahead, sir.

Thank you, operator, and thank you all for participating in today's call. Joining me are Dan Goldberger, Chief Executive Officer; Brian Posner, Chief Financial Officer; and Dr. Peter Staats, electroCore's Chief Medical Officer.

Earlier today, electroCore released results for the quarter and year ended December 31, 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, March 11, 2021. And with that, I'll now turn the call over to Dan.

Thank you, Hans. Hello, everybody, and thank you for joining us today. Full year 2020 revenue was $3.5 million, the upper end of our previously provided guidance range of $3.3 million to $3.5 million. Furthermore, net cash used for the full year decreased 55% to $20.2 million for the full year 2020 from $44.5 million for the full year 2019. Brian will cover the financials in detail, but I want to begin with a few highlights.

For the full year 2020, total revenue of $3.5 million increased approximately 46% as compared to $2.4 million for the full year 2019. We're pleased that the aggressive restructuring activities in 2019 and 2020 drove growth across our key revenue-generating channels, in spite of COVID-19 pandemic headwinds. During the fourth quarter of 2020, 2,647 total paid months of therapy were utilized across our 3 revenue-generating channels, resulting in net sales of $928,000, a sequential decline from 2,881 paid months of therapy in the third quarter of 2020, largely due to the third wave of COVID.

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 fourth quarter of 2020, 71 Department of Veterans Affairs and Department of Defense military treatment facilities purchased gammaCore products as compared to 68 during the third quarter of 2020 and 54 during the fourth quarter of 2019. Also, during the fourth quarter of 2020, the company shipped approximately 1,232 paid months of therapy pursuant to VA and DoD originating prescriptions, compared to 1,571 paid months of therapy during the third quarter of 2020 and 829 during the fourth quarter of 2019. Fourth quarter sales and paid months of therapy to VA and DoD facilities continue to be impacted by the ongoing COVID-19 pandemic, which saw case counts surge in many parts of the country in Q4 2020. Our sales and marketing function continues to leverage telehealth and other virtual capabilities, and management believes that the company remains well positioned to resume normalized outreach activities as the pandemic subsides.

Turning now to the United Kingdom and other OUS territories. During the fourth quarter of 2020, electroCore shipped approximately 1,143 paid months of therapy outside of the United States, as compared to 1,020 paid months of therapy during the third quarter of 2020 and 961 during the fourth quarter of 2019. Revenue generated outside the U.S. was $311,000 in the fourth quarter of 2020 as compared to $278,000 in the third quarter of 2020 and $294,000 in the fourth quarter of 2019. We were pleased to see a sequential increase in paid months of therapy, driven mostly by the U.K., which has been and continues to be hit very hard by the pandemic.

During the fourth quarter of 2020, we announced that gammaCore would continue to be reimbursed in England under the NHS Innovation and Technology Payment program, ITPP for the treatment of cluster headache in adults for an additional 6 months through March 2021. With the January notification that gammaCore was selected for inclusion in a new long-term reimbursement policy called NHS improvement MedTech Funding Mandate Policy '21/'22, we are confident that broad NHS England coverage will remain as our team works with NHS England to transition from the ITPP to the MedTech Funding Mandate Policy. In short, the policy supports commissioners and providers in the use of selected National Institute for Health and Care Excellence, or NICE, approved clinically effective and cost-saving medical devices, diagnostic and digital technologies that will improve patient outcomes. A projection by NICE concludes that more widespread adoption of gammaCore as an adult cluster headache therapy could deliver cost savings to NHS of as much as GBP 4.6 million over the next 5 years. We're grateful to NHS for their ongoing support of cutting-edge therapies such as gammaCore.

Similarly, we learned in January that Health Improvement Scotland, or HIS, has published a Scottish Health Technology group, SHTG, adaptation for NHS Scotland on the use of gammaCore for cluster headache. The SHTG adaptation is now being disseminated across NHS Scotland's health boards to inform the use of gammaCore for cluster headache.

In February 2021, we also learned that gammaCore's listing in the NHS supply chain catalog has been extended for an additional 2 years through June 3, 2023. The NHS supply chain helps NHS deliver clinically assured quality products at the best value to its patients, and the inclusion of gammaCore in the catalog allows hospitals to purchase gammaCore Sapphire for their primary headache patients, taking into account their own budgetary restrictions. The listing of gammaCore Sapphire as an e-direct product marks an important milestone in the company's provision of its medical technologies to U.K. patients in an easier, cost-effective way.

In recent months, we took meaningful steps to expand gammaCore's global availability. In December, we announced an exclusive distribution agreement with Pro Medical Baltic to distribute gammaCore in Eastern Europe, including Lithuania, Latvia, Belarus, Kazakhstan and Ukraine. In January, we entered into a similar agreement with RSK Medical in Canada. And most recently, in March, we announced an agreement with Medistar, who will serve as the exclusive distributor for noninvasive vagus nerve stimulation in Australia. We expect to expand our global network with leading medical technology distribution partners to make gammaCore more broadly available outside the U.S.A.

We continue to make measured investments in our commercial channel in the United States, most notably through negotiations with national and regional insurers and pharmacy benefit managers for the purpose of expanding the population of gammaCore-covered lives. In January 2021, we announced that CMS published its most recent level 2 health care common procedure coding system, commonly known as HCPCS, establishing a unique code K1020 for noninvasive vagus nerve stimulator. The coding decision covers the gammaCore Sapphire D and is in response to the application that we submitted during CMS' second biannual 2020 coding cycle for nondrug and nonbiological items and services. That application focused on the clinical and economic advantages of gammaCore therapy. All final coding decisions for the second biannual 2020 coding cycle for nondrug and nonbiological items and services will go into effect on April 1, 2021. We view the establishment of unique HCPCS code for noninvasive vagus nerve stimulation as an important differentiator from other nerve stimulator technologies and a potentially significant driver of additional coverage within the medical benefit pathway. We still have a lot of market access work to do and remain optimistic that the unique code will contribute to meaningful commercial reimbursement wins in the future.

On the topic of the COVID-19 pandemic, our employees in Rockaway, New Jersey and in the field continue to implement best practices for preserving the safety and health of all of our stakeholders. The FDA emergency use authorization, or EUA, that was granted to us in July 2020 for the use of gammaCore Sapphire CV at home or in a health care setting for the acute treatment of adult patients with known or suspected COVID-19 continues to generate clinician interest. gammaCore Sapphire CV is available throughout our VA DoD channels to hospitals, directly from the company through a premier specialty pharmacy by obtaining a prescription from a patient's health care provider, or through a telehealth consult powered by our telehealth partner, UpScript, LLC. We've also set up an online portal for patients to use, www.getgammacore.com. While prescriptions generated through the EUA were not a meaningful source of revenue during the fourth quarter, we continue to be pleased with the interest that it is generating in nVNS as a viable therapy. At this point, I want to ask our Chief Medical Officer, Dr. Peter Staats, to provide an update on our various clinical initiatives.

Thanks, Dan. You will recall that gammaCore Sapphire CV is currently being evaluated in 2 investigator-initiated clinical trials, or IIT, in hospitalized Covid patients, one in Valencia, Spain; and the other in Pittsburgh, Pennsylvania. These studies, known as SAVIOR-1 and SAVIOR-2, respectively, are measuring the safety and efficacy of gammaCore 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. SAVIOR-1 enrollment completed at 110 subjects, and our SAVIOR-2 trial, which aims to enroll 60 hospitalized COVID-19 patients, is ongoing. We look forward to seeing preliminary data from SAVIOR-1 later this year.

In December of 2020, we announced that gammaCore had been selected by the National Institute on Drug Abuse for a NIDA-sponsored randomized controlled study in opioid use disorders. The study will assess the ability of nVNS to decrease opioid cravings in subjects with a history of opioid use disorder who are stable on medication, as well as examine the possible mechanisms that might facilitate this clinical effect. The study is being run by Douglas Bremner, a leading researcher in this field, who you may recall is also leading a VA-sponsored study of gammaCore in PTSD.

Just a few weeks ago, we announced that full enrollment had been achieved in the TR-VENUS study, which is evaluating the utility of nVNS for the acute treatment of stroke. TR-VENUS is a Phase-II double-blind, randomized, sham-controlled, multicenter clinical trial conducted at 9 major centers across Turkey, supported by the Turkish Neurological Society and partially funded through an unrestricted research grant from electroCore. There is a strong scientific hypothesis supporting this study as preclinical evidence suggests that vagus nerve simulation can provide a measurable improvement in outcomes after ischemic brain injury. We look forward to reporting data from the TR-VENUS trial later this year as well.

In December 2020, we announced positive top line results from our PREMIUM II study of gammaCore in migraine prevention. Recall that this study was terminated early in April of 2020 due to the COVID-19 pandemic. However, an analysis of the data demonstrated that all study endpoints, including several patient-assessed quality of life measures, showed benefit from noninvasive vagus nerve stimulation, with many endpoints showing a statistical significant improvement with nVNS compared to sham stimulation. The positive results of PREMIUM II add to the significant body of evidence demonstrating that nVNS is among the most effective, safe and flexible treatments available to help patients looking for a way to take control of their headache treatment. We look forward to a peer review publication of the data later this year.

In another positive development on the migraine front, just a few weeks ago, FDA cleared our 510(k) submission to expand gammaCore label to include the acute and preventive treatment of migraine in adolescents between 12 and 17 years of age. It's estimated that 10% of all school-aged children and up to 28% of teens between the ages of 15 and 19 live with migraine. And we believe that a nondrug treatment option will resonate with this patient population. With this expansion, gammaCore is now cleared for most forms of primary headache.

Finally, in February of 2021, we announced the publication of a study in the journal Colorectal Disease that further demonstrates the broad potential of nVNS. The study evaluated the effectiveness of nVNS in preventing postoperative ileus following elective major colorectal surgery. Postoperative ileus is a serious condition that can result in complications from surgery and extended hospital stay. While only a pilot study, the group using nVNS showed a greater improvement in several clinically important endpoints, such as decreasing the amount of oral morphine equivalent used in post surgery compared to the sham group. The results detailed in this paper strongly suggests continued development in this indication, and a larger study funded by the National Institute for Health Research in England is ongoing. We are thrilled that the ongoing clinical studies of nVNS in headache, PTSD, Covid, opioid-use disorders, stroke, post-op ileus and other indications may ultimately improve the lives of our patients everywhere. We are also optimistic that the foundation clinical work will increase the total addressable market for nVNS as evidenced by the label expansion to adolescent migraine last month. At this point, I'll turn the call over to Brian for a review of our financials and other guidance items. Brian?

Thanks, Peter. For the quarter ended December 31, 2020, electroCore reported net sales of $928,000 as compared to net sales of $1.081 million in the third quarter. The sequential decrease in revenue was due to the ongoing effect of COVID-19, particularly in our VA and DoD channels. Revenue for the quarter ended December 31, 2019 was $675,000. Paid months of therapy shipped to the VA and DoD declined 22% sequentially to 1,232 in the fourth quarter of 2020 from 1,571 in the third quarter. Revenue from the VA and DoD also declined sequentially to $509,000 in the fourth quarter of 2020 from $646,000 in the third quarter. Revenue from the VA and DoD was $378,000 during the fourth quarter of 2019.

Paid months of therapy shipped outside the U.S. increased 12% to 1,143 in the fourth quarter of 2020 from 1,020 in the third quarter. Revenue from outside the U.S. increased sequentially to $311,000 in the fourth quarter of 2020 from $278,000 in the third quarter. OUS revenue was $293,000 during the fourth quarter of 2019. Net revenue from the commercial channel was $54,000 for the fourth quarter of 2020 as compared to $112,000 for the third quarter. Gross profit for the fourth quarter of 2020 was $109,000, inclusive of an increase of $434,000 in inventory reserves as compared to $284,000 for the fourth quarter of 2019. Gross margin for the fourth quarter, excluding the increase in inventory reserves, was 59% compared to 42% in the fourth quarter of 2019.

Total operating expenses for the fourth quarter 2020 were approximately $6.4 million as compared to $8.9 million for the comparable period in 2019. SG&A expenses declined approximately 26% to $5.4 million in the fourth quarter of 2020 from approximately $7.3 million for the comparable period in 2019. Research and development expenses decreased by approximately $600,000 or 37% to $1 million in the fourth quarter of 2020 from $1.6 million in the year ago period. This reduction is consistent with the company's strategy of significantly reducing its near-term investment in research and development as well as early termination of the PREMIUM II study in March of last year.

GAAP net loss for the fourth quarter of 2020 was $6.3 million compared to a GAAP net loss of $8.5 million in the fourth quarter of 2019. Adjusted EBITDA net loss for the fourth quarter of 2020 was a loss of $4.3 million as compared to an adjusted EBITDA net loss of $6.7 million for the same period in 2019. The company defines adjusted EBITDA net loss as GAAP net loss, excluding income tax expense or benefit, depreciation and amortization, stock compensation expense, write-off of right-of-use operating lease, increase in inventory reserves, 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 this afternoon's press release.

Now looking at the full year. For the full year 2020, we generated total revenue of $3.5 million as compared to $2.4 million for the full year of 2019. The gross profit for the full year 2020 was $1.8 million, inclusive of an increase of $434,000 in inventory reserves as compared to $1.2 million for the full year 2019. Gross margin for the full year 2020 was 50% as compared to 52% for the full year of 2019. Excluding the increase in inventory reserves, gross margin for full year 2020 was 63%.

Total operating expenses were $26.5 million for the full year 2020 as compared to $47.3 million for the full year 2019. The decrease in full year operating expenses was due to significant reductions in our cost structure implemented during 2019 and 2020, as well as the elimination of costs related to our Premium II trial, which terminated early due to Covid. GAAP net loss from operations for the full year 2020 was $23.5 million as compared to $45.1 million for the full year 2019. Our adjusted EBITDA net loss for the full year 2020 was $18.4 million as compared to $39 million for the full year 2019.

Cash, cash equivalents and marketable securities at December 31, 2020 totaled $22.6 million as compared to $24.1 million at December 31, 2019. Subsequent to the end of the fourth quarter of 2020, the company raised approximately $6.9 million through the company's previously announced stock purchase agreement, resulting in a pro forma cash balance of $29.5 million as of December 31, 2020.

For the fourth quarter of 2020, our net cash usage was $3.7 million, representing a decline as compared to both the third quarter 2020 net cash usage of $4.1 million as well as fourth quarter 2019 net cash usage of $9.4 million. Looking ahead, for the first quarter of 2021 we expect net revenue to be approximately $1 million and net cash usage to be in a range of approximately $4.5 million to $4.8 million. The increase in expected net cash usage in the first quarter of 2021 compared to the fourth quarter of 2020 is largely due to seasonal factors affecting working capital. And now I'll turn the call back over to Dan.

Thank you, Brian. We're pleased with our performance during the quarter and the year as we achieved several important milestones related to commercialization of our headache indications and ongoing clinical work. I also want to point out that we believe we are in a very healthy financial position, with pro forma cash of $29.5 million on the balance sheet as of December 31, 2020, including the subsequent $6.9 million raise mentioned earlier and substantial success in reducing our burn rate.

As the pandemic recedes, I'm excited about the prospects of returning to sequential revenue growth in our VA DoD headache market and achieving accelerated growth in our U.K. subsidiary as the MedTech Funding Mandate takes effect later this year. Our unique HCPCS code will become effective in April 2021. And I'm optimistic that the regional MACs and other national and regional payers will become increasingly receptive to reimbursement of nVNS therapy as we go through 2021. We've recently announced 3 new international distributors, and I look forward to continued expansion of that channel throughout the year. Longer term, label expansions beyond cluster and migraine, supported by the exciting ongoing clinical developments that Dr. Staats discussed, could dramatically increase the total addressable market for nVNS therapy. Finally, I want to again recognize our dedicated staff for working steadfastly through the pandemic disruptions and to thank the health care professionals that prescribe gammaCore and their patients for their loyal support of gammaCore therapy. At this point, we'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.

Great. Thank you, and good afternoon, everyone. And Brian, appreciate the guidance for the first quarter. It's helpful. Maybe, Dan, for you, you guys have -- you recognized a little bit of sales in the commercial channel this quarter. I'm just wondering if you could kind of give us some flavor on the tenor of the conversations in the commercial channel. It's poised to be a good opportunity for you going forward. Kind of where are they at today? And how would you characterize kind of the requirements you have given the coding updates you've gotten and kind of where you're at? So let's maybe start there and then I can turn to one other question.

Yes. So thanks, Ryan. We've said previously, we have -- on the commercial side, we have roughly 12 million covered lives through CVS and through Express Scripts. And those patients are paying $25 up to as much as $75 per month as a co-pay. So there is an out-of-pocket component to that. The challenge is that, that's not critical mass. We really need to get to a much larger number of covered lives in order to make the e-commercial channel an efficient call point. The new -- the HCPCS code that goes live in April is a huge step forward. Right now, all of our prescriptions get coded to miscellaneous. Once we have a unique code, that sets the stage for us to negotiate with the regional MACs about Medicare coverage. But even more importantly, it streamlines the process for the national and regional private insurers to do the same, to establish unique coverage to add us to more and more of their benefit plan. So all that work is going to be kicking off really in earnest in April once the code goes live and we can run test scripts and we can have specific conversations with different insurance companies around their benefit plans. So a lot of work yet to do over the course of 2021. Look for additional announcements about coverage decisions as we go through this year. But the revenue lift is really going to come in 2022 as we can take advantage of those coverage wins in the back half of the year.

Okay. I appreciate that color, Dan. That's helpful. And then on the OUS side, the NHS continues to be a solid area for you as a commercial channel, but you now have added Australia, Canada, some Eastern European countries as far east as Kazakhstan. So I think there's some sales minimums associated with those agreements. And just want to understand how to think about that incrementally relative to, say, the NHS? And could we see a much broader and diverse, I guess, revenue contribution internationally this year as we move through the year and maybe as Covid subsides?

Yes. So you're absolutely right. Iain Strickland is our U.K. General Manager of our U.K. business, and he's got the broad scope to build up our business around the world. Using our success in the U.K. under a national health care system as a template, we're becoming more and more attractive to stocking distributors around the world. And to your point, not only do those agreements have some obligations for sales, but they also come with some upfront commitments to buy product from us at a fair transfer price to be used in launching.

So you definitely see a revenue lift, not so much in the current quarter, but as we roll through the year, and you're also going to see additional distributor announcements as we go through 2021.

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

This is actually Danny on for David. My first one, so you guys have taken steps to mitigate spending in 2020, and I appreciate the color as far as guidance for the first quarter. But I was just curious, how should we think about operating expenses and cash burn for 2021? You mentioned should have more normalized outreach once Covid subsides. So are there any costs that will come back online post Covid that we should be keeping in mind? Or any other color there would be really helpful.

Brian, you want to take that one?

Yes. Sure, Dan. Yes, basically, I think the way you look at it, we've done a significant reduction in costs over '19 and 2020. I think we're going to make targeted investments where it makes sense in sales and marketing. We've made some additional investments in the government channels that we announced late in 2020. And the cash burn going forward is going to be largely dependent on our revenue growth. And as I've said in the past, we have a lot of inventory. We just reported a $5.7 million of inventory on our balance sheet. But the good news is, after all that use of cash to acquire that inventory, that will be a source of cash as we sell it. So that will be where cash is more favorable than GAAP results as we start ramping up revenue going forward in 2021 and beyond.

Great. And then I just had one follow-up. In the past, you had talked about the benefits that gammaCore could bring to an adolescent audience and given that it avoids systemic impact of pharmaceuticals. So could you just give us any color on how significant of a market this could be as you look at it here in the short term as well as in the mid and long term? And what next steps in this indication, what could those look like? Would it be marketing campaign, patient outreach? Anything along those lines would be great.

Yes. And thank you for noticing. It's been a long time coming, and you're absolutely right, getting the label extension to adolescents is a significant business opportunity for the company over the long haul. Step one is for us to -- because it's brand new, step one is for us to educate the prescribers, primarily headache specialists. But as you know, adolescent migraine is managed by more than just the neurology headache specialists. So we have a substantial awareness opportunity ahead of us, working with our small but nimble direct sales force, but really trying to leverage that with the awareness campaigns through social media and other media outlets. So for this year, it's going to be building awareness. There are some headache specialists that we've been in contact with who specialize in adolescents. So we expect to be able to talk about -- to brag about some early clinical successes in the adolescent population, anecdotally. So again, not a whole lot of lift in 2021, but really setting the stage for a substantial increase in our total addressable market in 2022.

Our next question comes from the line of [Sean Kay] with H.C. Wainwright.

Regarding ex U.S. distributorship, do you have any ongoing additional discussions for additional distributorship in the ex U.S. division?

Yes, absolutely, and you can look forward to a few more announcements later in 2021 as we successfully conclude or launch some additional international distributors.

I see. And I'm not sure if you already mentioned, but regarding study data, do you expect to see or release any data from the stroke study by Turkish Neurological Society?

Yes. So the enrollment concluded one of the endpoints is reading CT scans, and that's going to take some time, but we should be able to -- we should see top line results from that trial in the second half of 2021.

Our next question comes from the line of Anthony Vendetti with Maxim Group.

Yes, just a follow-up on the commercial payer rollout. I know you have the new code. Just can you talk about the strategy, how are you going to approach each commercial sort of the time line for getting some of the commercial payers on board?

So the line was a little staticky, but I think you were asking for timing of additional commercial payer announcements, and the 12 million covered lives that we have today are on -- are skewed towards those very high end, what you would consider Platinum benefit plans. There are several payers that have signaled their intention to cover once the code goes live through their medical benefit pathways. And so we'll have to run those test scripts in April to validate all of that. So you may see some announcements as early as May or June through those benefit plans that have previously signaled that they're going to cover the therapy. But that would be an upside. The heavy lifting is going to be negotiations with the regional MACs, which never go quickly, and the various national health care plans to see what we can do to make gammaCore therapy covered on a wider range of their benefit plans.

So on the regional MACs, just to clarify a little further, there's about 20 of them, if I recall.

No, four. There's only 4 of them.

Oh, the regional ones. Right. Okay. So there's 4 regionals. If you cover the 4 regionals, is that as deep as you need to go? Or is there negotiations that have to go on within each regional map, or is the regional all you need?

Our understanding is that the 4 regional MACs would cover Medicare throughout the continental United States. Now the devils in the details, right? Are we going to be satisfied with the limitations that they're going to try and put on the therapy? So it's really too early to tell how much of the Medicare population we're going to have access to at a price that we're comfortable with.

Okay. Okay. And then if we look next, and I know stroke is one indication. Is that what you would think is next in line? And then if you could -- maybe if you or Peter could talk about sort of the pipeline where you believe gammaCore could be used in addition to migraines and stroke?

So let me take the first half of that, and I'll hand it over to Peter. Actually, first of all, adolescent is a very big deal for us, and we're thrilled that we were able to make that announcement here a few weeks ago. I think you're next going to see us look for label expansions into secondary headache, so things like post-traumatic headache. From there, as Peter mentioned, there's work going on in other neurological conditions like traumatic brain injury and ultimately to PTSD. I think you'll see us moving, in terms of commercialization, moving in those directions first. Peter, do you want to talk about the pipeline in -- more generally and longer term?

Sure. Look, I think one of the great advantages of this therapy is that it's an almost untapped therapy. That's also one of the disadvantages that we have. And we've seeded studies -- initial studies in a variety of areas. Some of the areas that I personally am most excited about is PTS or PTSD. And this is an area of great unmet medical need without much competition, and our military folks and others desperately need a therapy here. Dan just mentioned post-traumatic headache, and that's kind of -- feeds into CTE and other broad areas of interest for us that is starting to get seeded. Opioid use disorder I mentioned, Doug Bremner is doing some work there, and there's a lot of signals that should work. But one of the really very exciting things is, again, we're going to follow the data, is our first -- TR-VENUS, our first stroke study. And when we see the data on can we modify the course of the disease, can we decrease the size of an infarct, I think that's going to also help direct our path. It's not all a foregone conclusion of which way we're going to go. It's really going to take the data from the numerous IITs that are ongoing and then really double down and invest in the right areas. But the good news is we have a lot of different opportunities with a lot of data coming in over the coming months to year.

(Operator Instructions). Our next question comes from the line of John Vandermosten with Zacks SCR.

Congratulations on distribution agreements and improvement in penetration to NHS. I wanted to ask about any possible further expansion in the British Isles. I guess Northern Ireland, perhaps? Is that something you can expand into? I'm not sure how the NHS works but that seems like maybe another area you could go into. Is that possible?

Yes, absolutely. You'll see Wales, you'll see Ireland and you'll also see some other European entities in coming months.

Okay. Great. And will the distribution be with a partner for Western Europe? Because I feel like that's kind of the next place you're going to go. Or will you run it through the current -- the same channel as it goes to NHS?

So in the U.K., we have a small direct organization. It's been very successful working with NHS to gain robust coverage that we have, but we really don't have the resources to go direct in any of the large European countries. So right now, we're leaning towards more traditional stocking distributors, leveraging what we've learned, leveraging the health care economics -- health care economic data that came in the NICE publication last year. And there's going to be some new data coming out in the form of post-market surveillance of our large cohort of the U.K. patients that's going to be very compelling for other...

Okay. And also, you mentioned a bit about the distribution agreements, Canada, Australia, Eastern Europe. Should we see contributions from all of these areas before the end of the year?

Yes, absolutely.

Okay. And then moving on to the studies. You mentioned a bit about this. I just wanted to extend a little bit. So if we see some success in some of the VA studies or the stroke or opioid abuse, do you anticipate getting external money to fund those? Because it seems like there's a lot of external interest. Or do you think that's going to have to be something that's funded internally?

Will -- we assess the business case for each opportunity to extend the label separately. Some of them like post-traumatic headache, secondary headache, those are initiatives that we believe we can fund ourselves that fit very, very nicely into our existing channels. Others, like acute treatment of stroke, will have a more involved development process, may or may not require a pivotal trial. And so we may look for a commercialization partner for something like acute treatment of stroke. And so what I -- electroCore is that we have this pipeline of [clinical] decisions, platform therapy, as Pete mentioned. And so we have this great wealth of opportunities ahead of us. And -- but given limited resources, we have to triage them appropriately.

Thank you. Ladies and gentlemen, at this time, there are no further questions. I would like to turn the conference back to Dan Goldberger for closing comments.

Thank you, operator, and thank you to all of you that spent the time to dial in. We've had a very challenging 2020 between restructuring our business and amid the pandemic. We're really very, very fortunate to have the support of the investment community, of our employees, and most importantly, of our prescribing physicians and their patients. And so thank you all, and I hope to see you all again in a few months for our first quarter call. Bye-bye.

Thank you. Ladies and gentlemen, this concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.