electroCore, Inc. (ECOR) 2018 Q3 法說會逐字稿

Good day ladies and gentlemen, and welcome to the electroCore's third quarter earnings conference call and webcast.

(Operator Instructions) Also as a reminder, this conference call is being recorded.

At this time, I'd like to turn the call over to your host, Greg Chodaczek with the Gilmartin Group.

Please go ahead, sir.

Thank you, operator, and thank you all for participating in today's call.

Joining me are Frank Amato, Chief Executive Officer; J.P. Errico, Chief Science and Strategy Officer; and Glenn Vraniak, Chief Financial Officer.

Earlier today electroCore released plans and results for the quarter ending September 30, 2018.

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 materially differ from those anticipated or implied by these forward-looking statements.

Accordingly, you should not place undue reliance on these statements.

For a list of description of the risk 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 projects or forward-looking statements, whether because of new information, future events or otherwise.

The conference call contains time-sensitive information that is accurate only as of the live broadcast today, November 13, 2018.

And with that, I'll turn the call over to Frank.

Thank you, Greg.

Good afternoon, and thank you all for joining us today.

We've made significant progress on multiple fronts over the past 3 months, which was our first full quarter as a public company.

And I look forward to giving you an update on our commercial progress, specifically the launch of our gammaCore therapy here in the United States.

After that update, I'll turn the call over to Glenn Vraniak, our Chief Financial Officer, to discuss our third quarter financials.

Following that, I will give an update on the progress of our regulatory and clinical programs and then we'll open the call up for your questions.

To describe the performance of our launch to date, I'd like to talk about 3 key areas: sales force deployment and doctor coverage; insurance reimbursement and the progress we are making with the payers; and our overall sales strategy and performance.

You may recall that we received FDA clearance for the acute treatment of pain associated with migraine headache in adults on January 29 of this year.

In order to support the market, we began building out our commercial team, but we only commenced full commercialization at the beginning of the third quarter, following our June 22 initial public offering.

There have been over 11,000 prescriptions written in the United States for gammaCore this year alone.

In the third quarter, we generated slightly over 4,500 prescriptions, which was an increase of 33% compared to the second quarter.

This growth in prescriptions has continued apace as we booked more than 2,000 prescriptions in the month of October.

In the third quarter, we also experienced strong quarter-over-quarter growth in the number of physicians prescribing gammaCore.

In fact, there were nearly 1,500 unique prescribing physicians through the third quarter of 2018, which is an increase of 48% from the second quarter.

The sales team calling on these physicians was launched on July 1 shortly after our IPO, with 32 territory business managers in the field and supported by 5 medical science liaisons or MSLs.

On August 15, 6 weeks later, we launched gammaCore Sapphire, our next-generation rechargeable and reloadable version of the therapy.

Again, the gammaCore Sapphire, like the earlier gammaCore model, is a handheld vagus nerve stimulation delivery device shipped to the patient directly from our specialty pharmacy partners.

It comes with a recharging case and a unique RFID card that activates the device to dispense up to 30 2-minute doses of therapy per day for 31 days.

At the end of the month, a refill prescription RFID card authorizes another month of therapy delivery.

The gammaCore Sapphire is more convenient for patients, reduces unnecessary waste and significantly improves our gross margin by eliminating the need for the delivery of a new device with every monthly prescription.

Our launch objective was to completely transition the U.S. market to the new generation product within 8 weeks.

And I'm happy to report that we completed that mission on schedule as of October 15.

As of the end of the quarter, our sales team of 32 territory business managers had made contact with the majority of our 6,400 target physicians at least once, and our goal is to reach each prescriber 2 more times by the end of the year.

As with other therapeutics, we believe it will take an average of 4 to 6 interactions like these to influence physicians to begin prescribing gammaCore as a part of their regular practice.

And as we continue to build momentum in the marketplace and increase the number of patients who receive insurance coverage for our therapy, we will continue to strategically build out our sales team, moving to 48 sales territories over the next 12 months.

Our goal by the end of 2019 is to promote gammaCore to approximately 10,000 headache-treating doctors across the U.S. market.

Now let's turn our attention to payer coverage.

In the third quarter, we accomplished another key milestone, which was the publication of PRESTO, our acute migraine pivotal trial in a top-rated peer-reviewed journal, Neurology.

This journal, the official journal of the American Academy of Neurology graded the PRESTO study as Tier 1A evidence.

This completed the mission of achieving high-profile publications for each of our major pivotal studies supporting the acute treatment of cluster headache and migraine.

Peer-reviewed publications in high-impact journals and the grading of Tier 1A evidence are important factors in our discussions with pharmacy benefit management companies, insurance companies and the other members of the payer community.

All of them require that clinical evidence be published to provide validation of the safety and efficacy supporting the use of a new therapy under their review.

As we stated in our second quarter earnings call, our goal continues to be payer access for gammaCore among approximately 25% or 50 million of the 200 million commercial lives in the United States by the beginning of 2019 and to grow that to 50% or 100 million lives by the end of 2019.

I should note that the majority of patients with severe headaches are either women of childbearing age, which is true for migraine, or middle-aged men who are the majority of cluster headache sufferers.

The age-related prevalence of migraine and cluster headache in the population means that the Medicare population is not a priority for our payer strategy at this time.

So where are we with the commercial payers and PBMs?

Currently we have multiple reimbursement agreements in place.

The first of which is the CVS Caremark agreement, which will go into effect on January 1, 2019.

Under this agreement, we have been advised that approximately 30 million of the 65 million U.S. individuals managed by CVS Caremark will have access to our therapy as a Tier 3 product beginning in January of 2019.

Potential access to the remaining 35 million lives will be gained through continuing negotiations with the payers within the CVS network.

In addition to CVS Caremark, ProCare RX has included gammaCore as a nonpreferred brand beginning in Q4 of 2018.

ProCare RX services just over 5 million lives.

Additionally, beyond these PBMs in managed care organizations, we are in active dialogue with several other organizations for an additional 90 million lives, such as the 2 remaining large PBMs Express Scripts and OptumRx as well as several regional Blue Cross and Blue Shield providers, Aetna, Humana and Anthem.

Discussions for inclusion in the 2019 formularies are underway.

I am also pleased to report that we recently received a positive med tech innovation briefing outlining our effectiveness from the National Institute for Clinical Excellence also known as NICE, which is the organization in the United Kingdom that advises their National Health Service or NHS on reimbursement decisions.

To further support our payer presence, on October 22, we welcomed Ardelle Ferris to the electroCore leadership team as our Vice President of Managed Care.

Ardelle brings a wealth of prescription benefit knowledge and experience to electroCore, including 15 years of national account management experience at Pfizer and Vertex.

We are thrilled to have Ardelle working to enhance access to gammaCore for all migraine and cluster headache-suffering patients in the United States.

As commercial payers begin to reimburse their patients for our therapy throughout 2019 and beyond, we believe our reported quarterly revenue should become more predictable.

We also believe the number of gammaCore prescriptions, the number of unique and high-prescribing physicians prescribing gammaCore and the total number of commercial lives will be important variables impacting our operating results.

For the next several quarters, we plan to provide investors with these data points to help them better understand our commercial progress and the value we are creating.

And with that, I'll turn the call over to Glenn.

Thank you, Frank.

For the quarter ending September 30, 2018, we reported GAAP revenue of $150,972, a decrease of $132,267 from the third quarter of 2017.

This decrease is primarily due to the contra revenue remaining as a result of our voucher program that extended into mid-July.

Under this voucher program through mid-July, we would reimburse the specialty pharmacy for patient cost of gammaCore therapy at the time of dispense.

This would be the basis for recognizing contra-revenue against products sold previously to our distributor.

In mid-July, we shifted to the use of a free voucher program free voucher units, thereby, eliminating the need to reimburse the pharmacy for patient cost and the need to book contra revenue.

The cost of these units dispensed under the voucher program after mid-July were then booked to promotional expense.

And in this way, it appears much more like a sample program.

During the third quarter, approximately 95% of gammaCore prescriptions were dispensed under this promotional program.

And as a result, we're proud to report that we've delivered approximately $1.7 million in sales value of gammaCore therapy to patients through this program.

Additionally, our co-pay assistance program remains in effect.

This is where we assist patients that obtained commercial payer coverage with up to $100 of their co-pay at the time gammaCore is dispensed.

The impact on the gross to net for the 3 months ending September 30 of 2018 was $14,600.

We continue to believe these programs are accomplishing our objectives of providing patient therapy at no charge, demonstrating the benefits of gammaCore therapy to physicians writing prescriptions and promoting U.S. commercial payer coverage and coverage discussions as a result of patient and physician demand.

The gross profit for the third quarter of 2018 was $53,905 down from $154,921 in the same period of the prior year.

The total operating expenses for third quarter of 2018 were $13.6 million, which is an increase of $7.5 million compared to the same period in 2017.

The increase in operating expense was driven primarily by cost related to the expansion of the company's sales and marketing functions.

Operating losses for the third quarter of 2018 were $13.2 million as compared to the operating loss of $12.4 million in the third quarter of 2017.

Cash, cash equivalents and short-term investments on the balance sheet were approximately $80.5 million as of September 30, 2018.

And I'll now turn the call back over to Frank.

Thanks, Glenn.

Over the quarter we have received a lot of feedback about our therapy.

And I'd like to just take a moment to talk about a gammaCore patient in the mid-Atlantic region named Marie and how our therapy has changed her life.

Marie is a young professional in her early 30s who has been suffering from frequent migraines since she was in high school.

Like many of her fellow migraine auras, Marie's headaches have forced her to miss school, work, social events and family get-togethers.

In fact, Marie's migraines even forced her to give up running because many of her attacks are exercise-induced.

Marie had tried many different drug treatments, but between the side effects and the lack of efficacy she was getting, she wasn't getting the relief she needed to get her life back.

When we introduced gammaCore to Marie's neurologist, she recognized it was a new treatment approach for patients like Marie and decided that Marie was the ideal patient to start on therapy.

I'm proud to report that since starting on gammaCore, Marie hasn't had to sacrifice doing the things she loves.

And to quote Marie, "gammaCore allows me to get back to my life." Even when it doesn't completely eliminate the migraine, it makes the experience livable and allows her to get back to her day.

Marie takes gammaCore with her wherever she goes.

When she feels a migraine coming on in just a few minutes of treatment, she can carry on with her day.

She's even started running again.

And it's the dozens and dozens of stories like Marie that we hear from the field that put a personal touch on the successes we've experienced.

Now I'd like to take a few moments to discuss our clinical and regulatory process as we look to expand our labels deeper into headache and into fields like rheumatology.

I'd like to start off by recognizing the hard work that our clinical team has put in supporting our leading clinical investigators around the world in our numerous clinical trials and specifically call out their continued successes in presenting and publishing the data from our key clinical studies.

Just in 2018, we have seen publications of more than a dozen clinical papers.

These include 3 in the Journal of Headache and Pain, 3 in Cephalalgia, 2 in Neuromodulation as well as Neurology and the Annals of Neurology.

In addition to date, in 2018, we've also made more than 20 presentations at the likes of the American Academy of Neurology, the European Headache Federation, the American Headache Society and the Migraine Trust Meetings.

As we have discussed, our gammaCore therapy is currently FDA-cleared for the treatment of pain associated with migraine, headache and episodic cluster headache.

The FDA-cleared these indications based on clinical study programs that were similar to those of traditional therapeutics for the treatment of acute headaches.

We've also conducted and published studies in the prevention of both cluster headaches and migraine.

Beginning with cluster headache, in late August, we filed an application for a 510(k) with the FDA for a label expansion for the prevention of these terrible headaches.

Our application is based primarily on results of our previously announced PREVA trial, which met its primary endpoint by demonstrating that daily adjunctive use of gammaCore therapy significantly reduced the number of cluster headache attacks per week these patients were suffering with as well as data from several real-world data sets collected from the United Kingdom where gammaCore is already approved for cluster headache prevention.

Our PREMIUM II study for the prevention of migraine in the United States, which is intended to extend the findings from PREMIUM I has received initial IRB approval, and I'm happy to report that we've enrolled our first several patients just this past week.

Our ATOM study of gammaCore as an acute treatment for adolescents has also received initial IRB approval and is expected to enroll its first patient shortly.

Our first formal investigation of gammaCore as both an acute and preventative treatment of posttraumatic headache will be submitted for IRB review this quarter.

As we look beyond the field of headache, the scientific and early clinical evidence supporting the use of vagus nerve stimulation in the treatment of inflammatory conditions is also compelling.

As we reported during the last earnings call, electroCore is expanding the platform use of gammaCore into rheumatology.

Currently we are awaiting results of a pilot study among Sjogren's syndrome patients being conducted in the United Kingdom.

And as we look into the early part of 2019, electroCore will be initiating multicentered randomized studies in rheumatoid arthritis.

In addition, smaller trials will begin with our research partners initiating enrollment of investigator-initiated studies in Raynaud's phenomenon, chronic fatigue syndrome and fibromyalgia.

They may serve as the foundation for larger trials someday.

In closing, we are pleased with our performance in the third quarter as we successfully rolled out the next generation non-invasive vagus nerve stimulation platform, the gammaCore Sapphire, increased our sales force to 32 territory business managers, sequentially grew the number of prescribing physicians by nearly 50%, gammaCore prescriptions by over 33% and continue to have constructive discussions with large pharmacy benefit management and managed care organizations and submitted a 510(k) for the prevention of cluster headache.

I'm very proud of everything that we've accomplished in this last quarter and I'm thrilled patients who suffer from painful and debilitating migraine headaches, like Marie, or episodic cluster headaches now have a safe and efficacious nondrug treatment option.

And with that, operator, please open the call up for questions.

(Operator Instructions) Our first question comes from Josh Schimmer from Evercore ISI.

It sounds like demand for the product has grown nicely.

But at least relative to where some of the numbers were set, the ability to convert patients from a prescription to a paid prescription -- a label prescription to a paid prescription is lagging a little bit.

So first of all, how should we think about the fourth quarter of 2018?

Is this really a year where it's -- we shouldn't be expecting much in the way of paid prescription growth?

We're also 6 weeks to the end of 2019, so maybe you could talk a little bit about your confidence of locking in some key PBM contracts so that you are more prepared for a swift adoption in 2019.

And then as we think about the dynamics that drove this quarter, if we were looking at the start of 1Q '19, when you feel like you'll be a little bit better positioned for reimbursement, what might this quarter have to look like if you had that type of access secure?

Thanks, Josh.

I think if we tack through the various questions here, the conversion from the gammaCore-S model to the gammaCore Sapphire model in the middle of October really positioned us to start to provide therapy for patients on a 1 or 2-month basis depending upon whether they were still appealing their insurer for either being denied access or they were waiting to hear back from the insurance company as to whether they were going to reimburse the product.

We think there'll be additional revenue and access with the payers through the PA or the prior auth process through the fourth quarter.

We're starting to see that already.

I don't have any numbers to report at this point in time, but we're starting to see conversion there, especially since it's been 3 weeks since we've converted the market over to the Sapphire product.

With respect to our confidence with the PBMs, 2 weeks ago, I was out meeting with the folks at OptumRx.

We're awaiting their contract proposal.

We discussed the tenets of the contracts, so we're going back and forth with them.

It's -- the ball is in their court.

We're waiting to get their contract back on what we discussed.

We've already negotiated with ESI back in the latter part of the summer, an agreement, a PBM agreement that would, I believe, be honored by ESI.

We'll learn more here when we hear back from the organization regarding their compendia.

They get their codes or our unique identifier code from First Databank.

First Databank has 2 databases.

They have the Prizm system, which is where they put all the medical devices and the MedKnowledge system where they put all of the pharmaceutical products.

Since our code is like an NDC number, and ESI is a PBM, they only contract for that MedKnowledge group.

So they are working very closely with Asembia.

I was notified as of this morning that they're in current discussions with Asembia and First Databank on how to pull that code over into their systems so they can start honoring the agreement that we negotiated.

So we're pretty confident that, by the early part of 2019, that there'll be an agreement in place with both ESI and hopefully OptumRx.

I haven't seen the contract back from them, so I haven't signed anything yet, but I did sign the one from ESI.

With respect to Q1 of '19 and what that'll look like, I think Glenn reported that we had around $1.7 million in demand revenue for the previous quarter and the quarter before that, if you add the contra-revenue and the revenue we had in the quarter, I think it was around $1.4 million in sales.

So we're starting to see an escalation of the number of prescriptions that are being written, 4,500 for the third quarter.

We already had 2,000 in the first month of the fourth quarter.

So as we see that demand grow and we get access in the market, we think that we'll be on the type of trajectory for revenue in 2019 that most of the analysts were expecting.

Our next question comes from Charles Duncan from Cantor Fitzgerald.

Congrats on good first quarter of progress being a public company and as well the recent NICE publication and gammaCore Sapphire launch.

Had a few questions though, and I know that some people want to talk all about reimbursement, but it seems to me that, and not being Pollyanna here, but it seems to me that, first, you've got to get interest by prescribers.

And so I appreciate the information that you provided, Frank, on that in terms of what you're seeing in the market.

But I'm wondering beyond unique prescribers, could you give us some color on how many prescribers are using -- are prescribing more deeply within their practice?

And are they writing refill prescriptions for patients?

So are they seeing satisfied patients?

Is that reinforcing prescribing behavior?

And are they seeing patients come back for more?

Yes.

So we, probably in the quarter, on average, and this is over a 3-month period, looking at the various different months, had somewhere around 75 physicians who were writing pretty consistently 5 or more prescriptions, on some cases significantly more than that on a monthly basis for the product.

And we're also seeing patients come back that are having success like Marie that I mentioned earlier.

She's an actual patient down in the mid-Atlantic area that wrote one of the many, many e-mails that we get back into the organization about how helpful the product has been.

So we're seeing a lot of traction with a number of neurologists who believe that this product should be available for their patient population.

They're writing letters.

We've sent probably, at this point, 3 dozen letters into the payers across the United States supporting the use of our product for major academic centers and major headache centers in some of the large metropolitan areas to support the use.

And we feel very confident that the feedback we're getting about the therapy is one that will be refilled and used pretty broadly across the marketplace.

Okay.

And then this may be hard to answer with over 2,000 scripts in October.

But I guess I'm wondering what you're seeing in terms of market dynamics with the recent CGRP monoclonal antibody launches.

What kind of patients are being prescribed gammaCore?

And are you seeing patients use gammaCore on top of CGRP therapy?

Or is CGRP therapy really taking a bite out of the demand for gammaCore?

Yes, so I think early on when the CGRPs especially the first one was launched in the market back in May, we saw a bit of a flattening for that first month because there were a lot of patients that were waiting upon the CGRPs that were being warehoused in the marketplace by these practices.

And when the product was launched, patients were flooding into the practices waiting to get their product to be started on prevention.

Many of the patients, as you know, who get up into secondary care are the type of patients who have frequent episodic migraine or chronic migraine and we'll be using both a prevention and an acute therapy.

And the physicians have, across the market, told us that they'll be using -- at the society meetings and in some of our market research, they have indicated clearly that they'll be using together both gammaCore and the CGRPs as a way to prevent the headaches from occurring and then gammaCore for acute use.

So that's -- we fully expect the product to be used in that regard and someday when we have a migraine prevention indication, we fully expect that we'll be the type of product -- the only product that will be our value differentiation in the marketplace will be -- where we can be used both preventively or in a prophylactic manner like a CGRP and then also for breakthrough pain that occurs throughout the month.

So we see an opportunity for us to be a potential step-through therapy or the type of product from a value standpoint, both in cost and value to the patient who will have the therapy on board to treat every single headache they might have throughout the month as well as try to prevent some of the headaches from occurring as an option in the marketplace.

So feedback's been great from the doctors thus far.

That's helpful.

And then my final question regarding some of the clinical study efforts.

I myself am really intrigued with the adolescent use of the technology.

And I'm wondering -- I know it's early days with the ATOM study, but I'm wondering if you could give us a sense of timing of data from that study or any feedback on whether or not you're going to be able to provide enrollment numbers and then other clinical data over the course of 2019 that we could anticipate.

Sure.

I think the first thing we anticipate is -- sometime in the early part of 2019 is a potential prevention indication for cluster headache.

That will come from our PREVA study, and we will be the first and only FDA-approved product for the prevention of cluster headache.

So we'll have an opportunity for our field force to talk to the clinicians out there about using the therapy in the way we intended it from the beginning, which is to use it every day to prevent your headaches from occurring, twice a day, 2 minutes in the morning, 2 minutes at night and then again when you have breakthrough pain.

With respect to the adolescent data, we're going to look to enroll about 200 patients in that study.

It will be an acute use study, so we would expect that it will be a short study with respect to the amount of time a patient will be on the therapy before we can collect the data.

And that data across 200 patients, we'll probably take about a year to collect the data.

So I think by the end of 2019, we should be able to complete that trial, assuming that we get the type of patient interest in the marketplace.

I mean these are adolescents.

They are not necessarily the type of patients that you would see in neurology practices as adults who have chronic migraine, et cetera.

So we're going to work through identifying the patients and getting them into the trial as appropriate.

As far as additional data sets, we'll have some pilot studies that will potentially read out both in some of the grant studies that have been given to various different academic centers looking at our therapy across a variety of areas from both DoD and DARPA.

And there'll be some pilot studies in rheumatology that we may see data in.

But as far as our pivotal trials go, the PREMIUM II study and the ATOM study, I wouldn't expect to see those results until the latter part of 2019 or in the case of PREMIUM, because it's a prevention study, sometime in 2020.

Okay, that makes sense.

Thanks for the added color.

Congrats on the progress in the quarter.

Our next question comes from Dave Turkaly from JMP Securities.

Just to follow up on that last one quickly.

The PREMIUM II, I think you have mentioned that you may be able to get label expansion for prevention of migraine possibly in 2019.

Is that still the case?

I know the PREMIUM II study may take longer, but is it possible that you're going to use some -- a subset of that?

And could that label expansion still come in that time frame?

I think it's possible, David.

We have taken a position with the FDA to work with them first through cluster headache acute use through the ACT studies, which we got back, as you know -- back in the middle part of 2017.

And then we went through FDA with our acute use of migraine with the PRESTO study which took the FDA 76 days to approve.

We got that in the early part of this year.

Once we have confirmation or clearance by FDA for cluster headache prevention, then we'll bring our prevention data sets down to the FDA, and we'll discuss what we have.

And like in the past, they have instructed us as to whether they think we have a sufficient amount of information for them to consider.

And it's been a pretty open dialogue, and we've greatly appreciated the FDA's willingness to meet and kind of guide us in that regard.

So it is possible.

We do have multiple data sets.

We have the EVENT study, which was published in Neurology back in 2015.

It was a pilot study in prevention.

And we also have the PREMIUM 1 study and a variety of other pilot studies that have been published as well.

So we'll collect all that information and bring it back to FDA and see what their perspective is.

Great.

Then on the PBM front, I get the 35 million you have now, and it sounds like -- you mentioned ESI and OptumRx.

I was wondering if you could just remind us, maybe more specifically, between Optum and Express Scripts, where they stand in total covered lives?

And then, I think you mentioned the regional folks as well, the press release highlights 90 million additional lives.

I imagine -- I'm assuming that's on top of the 35 million you have today.

But if you could break any of those out, that would be helpful.

Sure.

So with OptumRx, they have 30 million lives that are aggregated amongst a bunch of different, smaller payers, from health spending account or high deductible patient types, if you will, as well as employers that they've aggregated in those 30 million.

That is the group of patients that we'll be negotiating for next with Optum.

We will not, at this point in time, be negotiating with Optum for United lives.

We'll be discussing their lives directly with United.

With regard to ESI, it's 34 million lives that they currently manage, and it would be an agreement that would allow us to discuss that agreement amongst the various different payers that they work with within their network.

So all told, the 90 million encompasses the current 35 million we have and then the 2 additional data sets of 30 million and 35 million or 34 million in the case of ESI.

Got you.

And then, I think you had mentioned, in addition to adolescents being an important potential subset of patients, pregnant women in our study that you maybe run it on that.

So I just want to confirm any update there.

And I imagine that, given the amount of folks that are impacted by this that are women in that kind of age group, that having some data on that population may be important looking ahead.

Yes, so that's predominantly a study that will be run in Italy with many of the sites that participated in our PRESTO study.

That study is currently enrolling patients.

It's a post-marketing study.

We're not going to look for "a label" with that information.

It will be a published -- presented and then published data set, along with what we're calling the REAL study as an acronym, R-E-A-L, which will be the use of our product both preventatively and acutely in a study where most regulatory groups want us to break out the 2 different patient populations and either run an acute study or a prevention study, but not use the therapy in combination.

Since we have CE Mark over in Europe for both, we're going to run a data set and then publish that as well.

That will likely be in several hundred patients, so that may take another year or more to publish or to get the data on that.

And since it's post-marketing, it's really up to the investigators to enroll those patients.

We're not putting a full support behind that because that's not one of the programs that we're trying to develop for regulatory or payer approval, so to speak.

Our last question comes from Sean Lavin from BTIG.

It's Marie on for Sean tonight.

I wanted to start and see if I could understand a little better what's happening with patients after they've tried the gammaCore sample program.

For those patients who are seeing success with it, how many of them -- I guess what percentage or any color you can give us on who's going through the prior authorization process, who's going through the appeals?

And if you have any insight into how long that PA process is taking?

And should we expect to see more of that next quarter?

Sure, Marie.

So with the advent of the gammaCore Sapphire being fully launched in the market on October 15, it's given us the opportunity to provide an RFID card to patients for up to 60 days of a trial or a sample basically free therapy as they navigate through their payer appeal and denial process.

We are expecting to have more traction with that program here as we move forward into the fourth quarter because more and more patients are working through getting prescribed the product, transitioning onto the RFID card and then working through their payers.

It's really an opportunity for them to stay on the therapy and get relief and fight for themselves as well as having their providers provide written letters and prior authorizations that they have to fill out in order to submit back into the payers.

So that's kind of our thought process there.

It's really around creating demand and demonstrating that there are successful patients who are on the therapy.

Whenever we have meetings with payers or the PBMs, they ask us to aggregate all the different payers -- excuse me, all the different patients within their network who have been prescribed the therapy over the past quarter or 2 quarters or from the beginning of the year.

And that's a great way for us to establish for them the number of people out there within their network that are getting benefit or are trying our therapy and willing to stay on the therapy through that time period.

Okay.

And then, it sounds like you'll have more covered lives as we enter 2019.

What are your early thoughts on a strategy of how to target patients covered by these payers?

Obviously, they're national providers, so -- national payers, so what's I guess the game plan for kind of targeting the properly covered patients?

Sure.

For our approach, we've been really focused on the patients who are seen by the neurologists, the headache treating neurologists in the United States, which at this point there are about 6,500 that we are targeting.

Those folks see somewhere in the neighborhood of about 5 million patients on an annual basis.

There's about 3 million or so that have migraine that are dissatisfied with current treatments.

That's data that was collected by various different patient advocacy groups and information that's been published over and over again over the past 10 years in the marketplace.

And the dissatisfaction for many of these patients is with Triptan therapy.

So they've typically failed 1 or more Triptan therapies.

And they're looking for other options as they go to see their neurologists.

Clearly, some of these patients are given preventative therapies like Botox and Topiramate and now with the advent of CGRPs, they'll be prescribed those as well.

But they still have breakthrough headaches.

I mean most of these prevention products are covering somewhere between 20% to 30%, maybe 40% of their headaches, if they're lucky.

There are some super responders that we've heard about.

We've had the same thing with our therapies and our prevention studies as well where folks are having 80% or more of their headaches that are being prevented.

But suffice it to say, those are the patients that we're targeting and have a pretty hyper focus on, if you will, in the marketplace.

We're not going out to primary care physicians at this time.

We're not adding in additional pain specialists or OB-GYNs until we clear the pathway with more payer coverage so that we don't burden the physicians in prescribing our product and getting frustrated on having to fill out prior auth and so forth.

Many of the neurologists that are seeing headache patients and only headache patients, we use our hub specialty pharmacy network as a way to help support them with the prior auth process and getting letters of medical necessity written, and so forth.

So we are taking a very strategic and hyper focus in the marketplace to support our customers and to make sure we get the right patients on therapy who, ultimately, are the ones that are looking for alternative medications and therapies in order to help with the burden that they're suffering.

This concludes our Q&A session.

At this time, I'd like to turn the call over to Frank Amato for closing remarks.

I want to say thank you to everyone for taking the time out to get on the call today and hear about our third quarter results.

We're very excited about the prospect of gammaCore Sapphire in the U.S. market and look forward to getting with everyone in the next quarter and reporting our results for the remainder of the year.

So thank you for your time today, everyone.

Thank you, ladies and gentlemen, for attending today's conference.

This concludes the program.

You may all disconnect.

Good day.