Q4 2020 electroCore, Inc. Earnings Call
[music].
Good day, ladies and gentlemen, and welcome to the left.
So of course, that's quarter of 'twenty free cash.
Currently at this time of it looked like on a listen only mode.
The question.
And instructions will follow at the time.
After all the mines that this conference call is being recorded at the.
As part of my life.
Your host Hans.
Please go ahead.
Thank you operator, and thank you all for participating on today's call. Joining me are Dan Goldberger, Chief Executive Officer, Brian Posner, Chief Financial Officer, and Dr. Peter Staats Electric Force Chief Medical Officer.
Earlier today electric were 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 $19 95.
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 the 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.
The electric cord 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.
As of the live broadcast today March 11th of 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 'twenty 'twenty revenues was three and a half million dollars. The upper end of our previously provided guidance range of three three to three and a half million dollars per.
Furthermore, net cash used for the full year decreased 55 per cent to $22 million for the full year 2020 from 44, and a half million dollars 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 the three and a half million dollars increased approximately 46% ex prepay.
The $2 $4 million for the full year 2019.
We're pleased that the aggressive restructuring activities in 2019 of 'twenty 'twenty drove growth across on our key revenue generating channels in spite of COVID-19 pandemic headwinds.
During the fourth quarter of 2000, 22647 total paid months of therapy were utilized across our three revenue generating channels, resulting in net sales of $928000 of.
The sequential decline from 2881 paid months of therapy in the third quarter of 2020, largely due to the third wave of Covid.
The federal supply schedule of our FSS, which encompasses the V. H D O D and other government and military agencies continues to be our most important revenue channel share.
During the fourth quarter of 2000, 2071 Department of Veterans Affairs, and Department of Defense military treatment facilities purchased Gam of core 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 of the company shipped approximately 1232 paid months of therapy pursuant to the a and D. O D originating prescriptions compared to 1571 paid months of therapy. During the third quarter of 2020, and the 829 during the fourth quarter of 2019.
Fourth quarter sales and paid months of therapy to be a D. O D 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 O U S territories during the fourth quarter of 2020 electric of course shipped approximately 1143 paid months of therapy outside of the United States as compared to 1020 paid months of therapy during the third quarter of 2020 and 906.
The one during the fourth quarter of 2019.
Revenue generated outside the U S was $311000 in the fourth quarter of 2020 as compared to $278000 in the third quarter of 2020 and $294000 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 the gamma core would continue to be reimbursing, the England under the N H S innovation and technology payment program.
T P P.
For the treatment of cluster headache in adult for an additional six months through March 2021.
With the January notification of the Gamma core was selected for inclusion in a new long term reimbursement policy called NHS improvement Med Tech funding mandate policy 'twenty, one 'twenty two.
We are confident that broad NHS, England coverage will remain as our team works with NHS, England to transition from the I T. P. P to the med Tech funding mandate policy.
In short the policy supports commissioners and providers in the use of selected National Institute for Health and care of excellence or N. I C. E approved clinically effective and cost saving medical devices diagnostics and digital technologies that will improve patient outcomes.
Our projection by you and I see he concludes that more widespread adoption of gamma core as an adult cluster headache therapy could deliver cost savings to NHS of as much as 4.6 million pounds Sterling over the next five years.
We're grateful to NHS for their ongoing support of cutting edge therapies, such as gamma car.
Similarly, we learned in January that health improvements, Scotland, or H I S has published a Scottish health Technology Group S. H T. G adaptation for NHS, Scotland on the use of gamma core for cluster headache. The S. H T. G adaptation is now being disseminated across NHS, Scotland health.
The words to inform the use of gamma court for cluster headache.
In February of 2021 we also learned the gamma cores listing in the NHS supply chain catwalk has been extended for an additional two years through June three 2023, the NHS supply chain of helps NHS deliver clinically assured quality product at the best value to its patients and the income.
Asian of Gamma core in the catalog allows hospitals to purchase gamma of course sapphire for their primary headache patients taking into account their own budgetary restrictions.
The listening of gamma of course, Sapphire as an EU direct product marks an important milestone in the company's provision of its medical technologies to U K patients and an easier cost effective way.
In recent months, we took meaningful steps to expand gamma Coors global availability of December we announced an exclusive distribution agreement with chrome medical Baltic the disc.
The gamma core on eastern Europe, including with the linear lots via Belarus, Kazakhstan and Ukraine in January we entered into a similar agreement with R. S. K medical in Canada, and most recently in March we announced an agreement with Med historic who will serve as the exclusive distributor for noninvasive vagus nerve stimulation.
And in Australia.
We expect to expand our global network with leading medical technology distribution partners to make gamma core of more broadly available outside the USA.
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 gamma core of covered lives.
In January of 2021 we announced the CMS published its most recent level to health care common procedure coding system, commonly known as H C. P. C. S. Establishing of unique code K 102 zero for noninvasive vagus nerve stimulator the coding decision.
Covers the gamut of course Sapphire G and as in response to the application that we submitted during C. M. S. Second biannual twenty-twenty coding cycle for non drug and non biological items and services.
That application focused on the clinical and economic advantages of Gamma of course, there all final coding decisions for the second biannual twenty-twenty coding cycle for non drug non biological items and services will go into effect on April one 2021, we view of the establishment of the unique H C. P C.
S 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.
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 are you a that was granted to us in July of 'twenty 'twenty two the use of gamma of course Sapphire.
The at home or in the health care setting for the acute treatment of adult patients with known or suspected COVID-19 continues to generate clinician interest.
Gam of course half of our C. V is available throughout our the idea of channels to hospitals directly from the company through the Premier specialty pharmacy by attaining a prescription from of patients' health care provider or through of telehealth consult powered by our telehealth partner up script L. L C.
We've also set up an online portal for patients to use.
W. W. W Dot get gamma core dotcom.
While the prescriptions generated through the EUA went out of meaningful source of revenue during the fourth quarter. We continue to be pleased with the interest that it is generating in the N. VNS is a viable therapy.
At this point I wanted to ask our Chief Medical Officer, Dr. Peter Staats to provide an update on our various clinical initiatives.
Yeah.
Thanks, Dan you'll recall that game of course Sapphire C. V is currently being evaluated in two investigator initiated clinical trials or I, I T and hospitalized COVID-19 patients one.
One in Valencia, Spain, and the other in Pittsburgh, Pennsylvania.
These studies no net savior, one and Savior two respectively are measuring the safety and efficacy of game of course have higher C V plus standard of care versus standard of care alone in patients hospitalized with COVID-19 across a broad range of clinical and laboratory of endpoints.
Savior, one enrollment completed at 110 subjects and our Savior two trial, which aims to enroll 60 of hospitalized COVID-19 patients is ongoing.
We look forward to seeing preliminary data from CAGR. One later this year.
In December of 2020, we announced that <unk> had been selected by the National Institute of drug of abuse for a night of sponsored randomized controlled study in opioid use disorder.
The study will assess the ability of the N VNS to decrease opioid cravings in subjects with the history of opioid use disorder, who are stable on medications as.
As well as examine the possible mechanisms that might facilitate this clinical effect.
The study is being run by Douglas Bremner, a leading researchers in this field who you may recall is also leading of V. A sponsored study of gamma core in P. P. S T.
Just a few weeks ago, we announced the full enrollment had been achieved and the T. Our venous debt, which is evaluating the utility of the N VNS for the acute treatment of stroke.
T. R. Venus is a phase II double blind randomized sham controlled multicenter clinical trial conducted at nine major centers across Turkey.
Supported by the Turkish neurological Society, and partially funded through the unrestricted research grant from electric car.
There is the strong scientific hypothesis supporting this study as preclinical evidence suggests that vagus nerve stimulation can provide a measurable improvement in outcomes. After a scheme of brain injury.
We look forward to reporting data from the T. Our venous trial later this year as well.
In December of 'twenty, 'twenty, we announced positive topline results from our premium II study of gamma core in migraine prevention.
Recall that the study was terminated early in April of 2020 due to the COVID-19 pandemic.
However, an analysis of the data demonstrated that all study end points, including several patient quality of life measures share.
The benefit from noninvasive vagus nerve stimulation.
With many endpoints showing of statistical significant improvement with N VNS compared to Sham stimulation.
The positive results of premium to add to the significant body of evidence demonstrating that N. VNS 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 of peer reviewed publication of the data later this year.
In another positive development on the migraine front, just a few weeks ago FDA cleared our five 10-K submission to expand gamma cord 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 age children and up to 28 per cent of teens between the ages of 15, and 19 live with migraine and.
And we believe that the non drug treatment option will resonate with this patient population.
With this expansion of gamma core is now cleared from most forms of primary headache.
Finally in February of 2021 we announced the publication of the study in the journal colorectal disease that further demonstrates the broad potential of N D N S.
The study evaluated the effectiveness of N VNS and preventing postoperative ileus following elective nature of colorectal surgery.
Postoperative ileus is a serious condition that can result in complications from surgery and extended hospital stay.
Well the only of pilot study the group using N D&S showed a greater improvement in single clinically important endpoint.
Such as decreasing the amount of all of morphine equivalent used in the post surgery compared to the Sham group.
The results detailed in newspapers 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 N DNS and headache P. T. S. D. Covid opioid use disorders stroke, postop alias and other indications may ultimately improve the lives of our patients everywhere.
We are also optimistic that the foundation of clinical work will increase the total addressable market for N VNS 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 electric car reported net sales of $928000 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 V. A N D O D channels.
Revenue for the quarter ended December 31, 2019 was 675000.
Paid months of therapy shipped to the VA and D. O D declined 22% sequentially to 1232 in the fourth quarter of 2020.
From $1005 71 in the third quarter.
Revenue from the VA and D. O D also declined sequentially to $509000 in the fourth quarter of 2020 from $646000 in the third quarter.
Revenue from the VA and D. O D was 378000 during the fourth quarter of 2019.
Paid months of therapy shipped outside the U S increased 12% to all of them.
743 in the fourth quarter of 2020 from 1020 in the third quarter.
Revenue from outside the U S increased sequentially to $311000 in the fourth quarter of 2020 from 278000 in the third quarter.
O U S revenue was 293000 during the fourth quarter of 2019.
Net revenue from the commercial channel was $54000 for the fourth quarter of 2020 as compared to 112000 for the third quarter.
Gross profit for the fourth quarter of 2020 was $109000 inclusive of an increase of $434000 of the inventory reserves as compared to $284000 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 per cent to $5 4 million in the fourth quarter of 2020 from approximately seven point of 3 million for the comparable period in 2019.
Research and development expenses decreased by approximately $600000 of 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.
As well 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 2020 was the 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 exclude.
Excluding income tax expense or benefit.
Depreciation and amortization.
Stock compensation expense.
Right off of right of use operating lease increase of inventory reserves restructuring and other severance related charges legal fees associated with the 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.
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 the one 8 million inclusive of an increase of $434000 and the 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 per cent 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 of 2020 as compared to $47 3 million for the full year of 2019.
The decrease in full year operating expenses was due to significant reductions in our cost structure implemented during 2019 and 2020.
As well of the elimination of costs related to our premium two trial, which terminated early due to COVID-19.
GAAP net loss from operations for the full year 2020 was 23 5 million of 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, total $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 previous announced stock purchase agreement.
Results in our 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 of 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.
With 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 to $4 8 million. The increase in expected net cash usage in the first quarter of 2021 compared to the fourth quarter of 2012.
<unk> 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 end of 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 of half a million dollars 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 receipts.
I'm excited about the prospects of returning to sequential revenue growth in our V E. G O D of headache market.
In achieving accelerated growth in our U K subsidiary is the Med Tech funding mandate checks. The exact later this year.
Our unique H C. P. C. S code will become effective in April of 2021.
And I'm optimistic that the regional Max and other national and regional payers will become increasingly receptive to reimbursement of N VNS therapy as we go through 2021.
Yes.
We've recently announced.
Three new international distributors and I look forward to continued expansion of that channel throughout the year.
The longer term label expansions beyond clustering of migraine supported by the exciting ongoing clinical developments the doctor starts discussed.
Could dramatically increase the total addressable market for N VNS therapy.
Finally, I want to again recognize that of a dedicated staff working steadfastly through the pandemic disruptions.
Andrew Thank the health care professionals, the prescribed gamma Cora in their patients for their loyal support of game of course 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. We'd like to ask the question. Please press star one on your telephone keypad. The confirmation tone will indicate your line is on the question you.
You mean, the starches, if you'd like to remove your question from the queue from participants using speaker equipment. It made the necessary to pick up the handset before pressing the star keys, one on the <unk>.
The only poll for questions.
Our first question comes from the line of Ryan Zimmerman with the T. I G. Please proceed with your question.
Great. Thank you and good afternoon, everyone in the Bryan appreciate the guidance for the first quarter of its helpful.
Dan for you you know you guys have you recognized a little bit of sales on the commercial channel of this quarter and I'm. Just wondering if you could kind of give us some flavor on the tenor of the conversations and the commercial channel channel it.
It is 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 got them in and kind of where you're at so let's maybe start there than in the Nike turned it on one of my question.
Yeah. So thanks Ryan.
The you know we've said previously we have on the commercial side, we have roughly 12 million.
Covered lives through Cvs and true express scripts and those patients are paying $25 up to as much of $75 per month as of as a co pay. So there is a an out of pocket component to that.
The the challenges that that's not a critical mass, we really need to get to a much larger number of covered lives are in order to the commercial channel inefficient call point the.
The new the Hick picks code that goes line in April is a huge step forward right now all of our prescriptions get get coded to miscellaneous once we have the 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.
Yes for sure.
The the national and regional.
The private insurers to do the same to establish unique coverage to add us to more and more of the benefit plan. So all of that work is going to be kicking off really in earnest in April once of 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 that's helpful and then.
On the O U S side, you know the.
NHS continues to be.
All of area for you as a commercial channel, but you now have added Australia, Canada.
Some eastern European countries as far east of Kazakhstan.
So.
I think theres some sales of minimums of associated with those.
Those agreements and just want to understand how to think about that.
The incrementally relative to say the NHS and can we see a much broader and diverse I guess revenue contribution internationally. This year as we move through the year and you know maybe as Covid subsides.
Yes, Youre absolutely right.
Ian Strickland as is our UK general manager of our UK business and he's got the the broad.
The broad scope to to build up our business around the world.
Using our success in the U K under the National healthcare system.
As a template we are becoming more and more attractive to stocking distributors around the world.
And to your point, you know not only of those agreements have some obligations.
For sales, but they also come with some upfront.
The commitment to byproduct from us at a fair transfer price to be used in launching so you definitely see of revenue lift you know not not so much in the current quarter, but.
As we roll through the year and you're also going to see additional distributor of announcements as we go through 2021.
Okay. Thanks for taking the questions guys.
<unk>.
Yeah.
Thank you it looks for the next question comes from the line.
David carefully the JMP Securities. Please proceed with your question.
Yes, Hi, this is actually Danny on for Dave. Thanks for taking the questions. 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 you know how should we think about operating expenses and cash burn for 2021, and you mentioned should have more normalized outreach.
Once COVID-19 subsides. So are there any costs that will come back on line post COVID-19 that we should be keeping in mind or any other color there would be really helpful. Thanks.
Brian you want to take that one yeah sure Dan.
Yeah, basically I think the way you are.
Looked at it yeah, we've done a inc.
A significant reduction in cost of over 19 in 2020, I think we're gonna make targeted investments where it makes sense in sales and marketing are you know we've made some additional investments in the government channel that we announced of 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 the inventory on our balance sheet.
But the good news is after all of that use of cash to acquire that inventory that'll be a source of cash as we sell it so that'll be a you know.
Where cash is more favorable than GAAP results.
As we start ramping up revenue growth going forward in 2021 and beyond.
Great and then I just had one follow up you know in the past you had talked about the benefits that came of course bring to an adolescent audience and.
Given that avoids systemic impacts of pharmaceuticals. So could you just give us any color on how significant of a market. It 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 what could those look like would it be you know marketing campaign.
Outreach anything along those lines would be great. Thanks.
Yes. Thank you.
Thank you for noticing it's it's been a long time coming and you're absolutely right getting the label extension to adolescence.
As a significant.
On this opportunity for the company over the long haul the.
Step one is for us too because it's brand new step one is for us to educate.
The prescribers are primarily headache specialists.
But as you know adolescent migraine is is managed by more than just the neurology headache specialists. So we we have a substantial awareness.
The opportunity ahead of us.
Working with our small, but nimble direct sales force, but really trying to leverage that with the.
The awareness campaigns through social media and other.
The 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 adolescence.
So we expect to be able to talk about to brag about some.
Some of our early clinical successes in the adolescent population.
Anecdotally so.
Again, not a whole lot of lift in 2020, one, but really setting the stage for.
<unk> the increase in our total addressable market in 2022.
Great. Thank you guys.
Thank you. Our next question comes from the line of Sean Kang with H C. Wainwright. Please proceed with your question.
Hi, Thank you for taking my question.
Regarding ex U S distributorship.
You have any ongoing additional discussion.
For additional distributors in.
In the ex U S region.
Yes, absolutely and you can look forward to a few more announcements.
Later in 2021.
As we successfully conclude.
Our 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 released any data from the stroke study.
By Turkish neurological Society.
Yes so.
The enrollment concluded.
One of the endpoints is is reading C T 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 excuse me in the second half of 2020 one.
Second half of 'twenty, one okay sounds good thank you.
Thank you. Our next question comes from the line of Anthony Vendetti with Maxim Group. Please proceed with your question.
Thank you.
Yeah, just a follow up on on.
On the commercial.
Per our rollout I know you.
The new the new code.
Can you talk about the strategy.
Approach each commodity.
What sort of of the time line.
No.
Some of the commercial.
Okay.
So on the.
The the line was a little Staticky, but I think you were asking for a timing of additional commercial payer announcements.
And the.
The the 12 million covered lives that we have today.
Our on.
The skewed towards those those very high and what you would consider.
The platinum benefit plans.
There are several payers.
That have.
Signals their intention to cover once the code goes live through their medical benefit pathways and so we'll have to run the test groups 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 had previously signaled a.
That theyre going to cover the therapy.
But that would be an upside are the heavy lifting is going to be negotiations with the regional Macs, which never go quickly.
And the various national health care plans to to see what we can do to make them of course of therapy are covered on a wider range of their benefits of clients.
So on the on the regional Max just to clarify a little further there's about 20 of them.
Recall four there's only four of them the regional ones right. Okay. So there's four regionals.
If you if you.
Cover the full of regionals is is that as deep as you need to go.
Or.
As the negotiations that have to go on.
Within each regional Mac or as the regional you need.
Of our understanding is that the therefore regional Macs would cover Medicare throughout the Continental United States now.
Now the Devil's in the details right or are we going to be satisfied with the.
The limitations of 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 are that.
We're comfortable with.
Yeah.
Okay. Okay, and then and then if we look next I know stroke is one one indication is that what you would think as is <unk>.
Next in line and then if you could maybe if you of Peter can talk about sort of the the pipeline.
We believe game of course, it could be used in addition to.
Migraines in stroke.
So let me take the first half of that and I'll I'll hand, it over to Peter.
You know actually you know first of all adolescence is at the very big deal for Us and we're thrilled that we were able to make that announcement here a few weeks ago.
I think your next going to see US look for label expansions into the secondary headaches of things like post traumatic headache of.
From there as as Peter mentioned, there's work going on.
In other neurological.
Neurological conditions.
Like traumatic brain injury in and ultimately the PTSD I think you'll see us moving in.
In terms of commercialization.
And those directions first.
Peter do you want to talk about the the pipeline in the.
More generally in longer term.
Sure look I think one of the great advantages of this therapy is that it's a it's an almost untapped therapy. That's also one of the disadvantages that we have.
And we've seeded.
Studies and in the initial studies in a variety of areas. Some of the areas that I personally I'm. Most excited about is P. T S of PTSD.
And this is an area of great unmet medical need without of.
Much of competition, and our military folks and others desperately need them.
You know of therapy here, Dan just mentioned post traumatic headache, and that's kind of.
T J two of Cte and other broad areas of interest.
For us that debt is starting to get seeded.
Opioid use disorder, I mentioned, Doug Bremner is doing some work there and theres a lot of signal of that should work, but what are they are really very exciting things as we can we're going to follow the data.
Is our first tier of Venus 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 on also help direct our path.
It's not all of foregone conclusion of which way we're going to do it's really going to take the data from the numerous II Ts that are ongoing and then really double down and the best 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 of year.
Okay. Thank you that's very helpful I'll jump back in the queue. Thanks.
Thank you as a reminder, ladies and gentlemen, if you'd like to ask a question. Please press star one on your telephone keypad. Our next question comes from the line of John then they're most of them with Zacks SCR. Please proceed with your question.
Good afternoon, everyone and congratulations on the distribution agreements and the improvement in the penetration of the NHS.
As of I wanted to ask about any possible further expansion in the in the British Isles I guess, the Northern island, perhaps does that is that something you can expand into I'm not sure how the NHS works of it.
That seems like maybe another area you could go into it is that possible.
Absolutely, you're you'll see you'll see wells, you'll see Ireland.
And you'll also see some other European entities.
In coming months.
Okay, great and well I'm well the distribution be where the partner for Western Europe, because I feel like that's kind of the next place youre going to go or where are you where you run it through.
The current are the same channel as it goes to NHS.
So in the UK, we have of small direct organization it's been.
The very successful working with NHS.
To gain the robust coverage that we have.
But we really don't have the resources to go direct in any of any or 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, a heck of the healthcare economic data that came in the and I see he put on location.
Last year.
And theres going to be some new data coming out in the form of post market surveillance of R. R.
A large cohort of the U K patients thats going on would be very compelling for the.
[laughter] growth.
Okay.
And also are.
You mentioned a bit about the of the.
Agreements cash.
And of the 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 just wanted to extend a little bit. So if we see some success on some of the VA studies or the the stroke or opioid abuse.
Do you anticipate getting external money to fund those because it seems like theres a lot of external interest or do you think that's going to have to be something that's that's funded internally.
Yes.
Will we assess the the business case for each.
The opportunity to extend the label separately.
Some of them like like post traumatic headache.
Secondary headache, those are initiatives that we believe we can fund ourselves and fit very very nicely into our existing channels.
Others like acute treatment of stroke.
We'll have a more involved.
[noise] development process.
On may or may not require of pivotal trial.
And so we may look for a commercialization partner for something weighted.
Yeah.
Q treatment of stroke and so what.
The electric Corey is that we have.
On this pipeline.
Submissions.
The platform therapy is as Pete mentioned.
And so we have this great wealth of opportunities ahead of us and but given the limited resources, we have triage them appropriately.
Great Alright, Thank you Dan.
Thank you ladies and gentlemen at this time there are no further questions I'd like to turn the conference back to Dan Goldberger for closing comments.
Thank you operator, and thank you to all of you that are spent the time.
The 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 <unk>.
Our employees and most importantly of our prescribing physicians and their patients. So thank you all and I hope to see you all in again in.
A few months from 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.