Zogenix, Inc.
Q4 2018 Earnings Call Transcript

Published: 1 Mar 2019

[Operator:]

Greetings, and welcome to the Zogenix Fourth Quarter and Full Year 2018 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation [Operator Instructions]. As a reminder, this conference is being recorded. I now would like to turn the conference over to your host, Brian Ritchie. Thank you. You may begin.

[Brian Ritchie:]

Thank you, operator, and thank you all for joining us this afternoon. With me on today's call are Chief Executive Officer, Dr. Stephen Farr and Chief Financial Officer, Michael Smith. In addition, Dr. Gail Farfel, Chief Development Officer and Ashish Sagrolikar, Chief Commercial Officer will also be available during the Q&A session. This afternoon, Zogenix issued a news release announcing financial results and providing a business update for the fourth quarter and full year ended December 31, 2018. Please note that certain information discussed on the call today is covered under the Safe Harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, Zogenix management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in Zogenix's news releases and SEC filings, including in the annual report on Form 10-K and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, February 28, 2019. Zogenix undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. Now, I would like to turn the call over to Steve.

[Stephen Farr:]

Thank you, Brian, and good afternoon to everyone who is joining us on today's call. I'm very pleased to speaking with you today to recap a landmark here is 2018 for Zogenix and to outline our planned activities for continued momentum for the company in 2019. During the past year, we announced highly positive results from our second global phase 3 trial of our lead product candidate, ZX008 or FINTEPLA for the treatment of seizures associated with Dravet syndrome in patients aged two years and older. Dravet syndrome is a rare and often-catastrophic epileptic encephalopathy that begins in infancy. The results of this trial were consistent and supportive of the outcomes reported from our first phase 3 study and position the company to advance the preparation of NDA and MAA submissions in pursuit of our first indication of Dravet syndrome. I'll say more about these data and submissions shortly. In 2018, we also continued to advance ZX008 through a single global phase 3 trial in our second planned indication Lennox-Gastaut Syndrome or LGS. LGS like the Dravet syndrome is a difficult to treat childhood onset epileptic encephalopathy for which new and more effective treatment and such greatly needed. In late 2018, we provided an update that based on progress achieved during the year, we would expect to complete enrollment for this global trial in the second half of 2019. Shortly after our second Dravet syndrome phase 3 trial readout we successfully completed our follow-on offering that generated net proceeds of $$293 million. With this offering, we ended the year with $514 million in cash, cash equivalents and marketable securities strongly position us to execute on our strategy to bring FINTEPLA to market as a therapeutic option for patients and families impacted by Dravet syndrome and other serious intractable epilepsy conditions. We have continued our strong momentum at the start of 2019, highlighted by the completion of the rolling submission of an NDA to the U.S. Food and Drug Administration and the submission of an MAA to the European medicines agency for FINTEPLA for the treatment of seizures associated with Dravet syndrome. I am pleased to report that the EMA has now accepted our MAA for review and we anticipate that in the approvability decision could be reached by the EMA in the first quarter of 2020. We expect to shift from the FDA in regards to the filing status of our NDA submission in the next several weeks. If the FDA grants priority review for contemporary NDA, we would anticipate a PDUFA target date in the third quarter of this year. These regulatory submissions represent a considerable achievement for Zogenix, and I would like to take a moment to extend my sincere thank to the patients and families, investors and staff and other experts who participated in the ZX008 clinical trial program over the last four years. I would also like to recognize all of my colleagues at Zogenix who have worked so diligently to make these submissions reality. With the date and the change in our clinical phase 3 program, we firmly believe FINTEPLA has the potential to be a compelling treatment option for Dravet syndrome. The regulatory applications in United States and Europe are based on data from the two pivotal phase 3 trials in Dravet syndrome that I mentioned earlier and an interim analysis from an ongoing open label extension study, Study 1503, which included 232 patients treated for up to two years. Both of the pivotal trials met their primary endpoints and all key secondary measures with high statistical significance. ZX008 rated all test doses resulted in rapid, clinically meaningful and durable reductions in convulsive seizures when added to patients' anti-epileptic treatments. This robust reduction in convulsive seizures was also sustained in the long-term open label study, which as I noted includes patients on therapy for now up to two years. ZX008 was shown to be safe and well-tolerated in the Dravet clinical program. No serious safety signals were observed and no new or unexpected tolerability or safety findings were identified. Importantly, an intensive prospective cardiovascular monitoring program shows that no patient developed valvular heart disease or primary hypertension at any time during study participation. Some of these data represented at the American Epilepsy Society or AES Annual Meeting, which took place in December of last year. We are now very excited to be in a position to ramp up our commercial preparations for FINTEPLA. We intend to market FINTEPLA in United States and Europe through our own commercial teams. In Japan, we plan to commercialize via partnership with an experienced pharmaceutical company to help expedite and maximize the FINTEPLA opportunity in that country. Our own commercial strategy is concentrated on three key principles. First, we are focused on raising awareness of FINTEPLA by educating physicians, patients and their families about our therapy. Next, we are building a robust infrastructure to ensure access and the seamless delivery of our product. Finally, we want to ensure that durable benefit with FINTEPLA is recognized that patients stay on therapy. Importantly, we have already achieved good progress in building and expanding our commercial organization. We have been fortunate to attract target sales leaders, marketing and market access professionals with specific experience in epilepsy and rare diseases. As we move closer to potential approval in the United States and Europe, we have our market access teams focused on developing various pharmaco-economic models to assist with payer and formulary discussions, including burden of disease and budget impact data. In addition, our specialty pharmacy operations is up and running. We have launched an early access program through key Dravet syndrome centers of excellence and our specaitly pharmacies providing FINTEPLA to participant in this early access program, which provides us with an opportunity to learn and refine our processes, which will help us to make FINTEPLA available to patients seamlessly when approved in the United States and Europe. Now, I would like to switch back to clinical development and discuss Study 1601, our ongoing global Phase 3 clinical trial for ZX008 in LGS. This double blind placebo controlled three-arm study is targeting a total of 225 randomized subjects between two and 35 years of age. Recruitment continues to progress well and now includes a significant number of European sites, which either have been activated or will shortly open during this quarter. We continued to anticipate the completion of the enrollment of this study in the second half of this year with top line results in the first quarter of 2020 consistent with our previously communicated timeline. I would like to conclude my remarks by highlighting Zogenix's objectives for 2019. We have already accomplished one key objective for the year with the completion of our NDA and MAA submission, and excited to have received confirmation today that our MAA has been accepted for review. We are now looking forward to learning of the acceptance pool filing of the NDA and receiving a PDUFA target date from the FDA. It is our objective to be ready to launch FINTEPLA in United States shortly after potential approval. Beyond Dravet syndrome, we anticipate the completion of enrollment with Study 1601 in LGS during the second half of 2019 with top line results expected in the first quarter of next year. In addition, we anticipate initiating a multicenter placebo controlled trial in Doose syndrome in the second half of 2019. I should add here that external interest in evaluating FINTEPLA also continues to grow and we are receiving an increasing number of investigated initiated study requests related to other epileptic encephalopathies on difficult to treat epilepsy syndromes. While we do not intent to provide update on these studies until data are available, we think the prevalence of these investigate initiated studies requests further highlights the potential of FINTEPLA. With that, I'll now turn the call over to Mike for his review on the financials. Mike?

[Michael Smith:]

Thanks Steve. I'll begin by reviewing our three month financial results for quarter ended December 31, 2018 as compared to the corresponding period in 2017. R&D expenses for the fourth ended December 31, 2018 totaled $23.6 million and that’s up from $18.1 million in the same three month period of the prior year as the company expanded its clinical trial activities in both the U.S. and Europe related to our development program of FINTEPLA and Dravet syndrome and LGS. SG&A expenses for the fourth quarter ended this year totaled $11.3 million compared with $7.8 million in the corresponding period in 2017. The increase in SG&A cost reflect our continued investment in preparations to potentially launch FINTEPLA as achievement for Dravet syndrome in the U.S. and in various countries in Europe in the coming years. We reported a net loss for the fourth quarter ended December 31, 2018 of $22.4 million or $0.53 per share and this compares to the net loss of $39.7 million or $1.17 per share from the prior year. Now, I'll review our results for the 12 months ended December 31, 2018 and compare them to the prior year's results. The company recorded no revenue for the 12 months ended December 31, 2018 and this compared with total revenue of $9.8 million in the 12 months period ended in 2017. 2017 revenue was derived from since discontinued products, notably SUMAVEL DosePro. R&D expenses for the year ended December 31, 2018 totaled $101 million and this is up from $67.4 million in the 12 months ended in 2017. Again, reflecting the aforementioned increased activity in our late stage development programs for Dravet syndrome and LGS. SG&A expenses for the year ended December 31st totaled $39 million compared to $25.9 million for the year ended December 31, 2017. We reported a net loss for the year ended December 31, 2018 of $123.9 million or $3.27 per share. And this compares to the net loss of $126.8 million or $4.65 per share from the prior year. We ended the year with cash and cash equivalents and marketable securities totaling $514.2 million as compared to $293.5 million at the beginning of the year. And we are well positioned, as Steve noted, to execute on our strategic plan to become a leading rare disease company and create significant long-term shareholder value. We remained focused on advancing our commercialization plans for FINTEPLA. Simultaneously, we continue to enroll patients in our second phase 3 program in LGS and are preparing to initiate a global multicenter placebo controlled trial in the Doose syndrome. Beyond FINTEPLA, we remain active in business development and continue to evaluate additional product development opportunities that could further leverage our core competences and expertise in identifying, developing and commercializing rare disease therapeutics that have a meaningful impact. As Steve noted earlier we have entered 2019 with significant momentum in our business and look forward to multiple key value inflection points on the horizon. 2018 was a transformative year for Zogenix and we look forward to opportunities to continued success in 2019. I'll now turn the call over to the operator to begin the Q&A session. Operator, could you please provide the instructions?

[Operator:]

Great, thank you. At this time, we will be conducting a question-and-answer session [Operator Instructions]. Our first question is from Paul Matteis from Stifel. Please go ahead.

[Paul Matteis:]

On the U.S. regulatory review of FINTEPLA, I was wondering if you would care to apply in your base case for both whether or not you get priority review and whether or not FDA will hold in that account? And then I have a couple of quick follow ups. Thanks.

[Stephen Farr:]

This is Steve. We did obviously apply for priority review as part of our NDA submission, but that decision obviously rests with the FDA. So we hope to hear obviously soon from the FDA with respect to acceptance of these filing and at the same time, we will get our PDUFA date. So we are hopeful that we will get priority review. But as I said, that decision is for the FDA to make. With respect to outcome, I think that’s almost the same answer. That’s obviously FDA's decision. We obviously didn’t get any clarity on that with respect to our interactions prior to the NDA submission. So that resonates and that’s something that they will review at the time that they accept the filing. So you should hear about the same time around whether or not there is an outcome. I'll say we are planning for one, especially prior to review cycle and then obviously there is not a lot of time for us to get ready for an outcome. So we went ahead and started our preparations for an outcome actually at the end of the last year and continued that aggressively this year.

[Paul Matteis:]

And then just two quick questions on Doose. I think previously you talked about conducting an investigator sponsored study in this indication. So I guess one, have you seen any early data there, any indication that this indication has a good success? And then secondarily maybe if you help or if you could just comment on how developed this market is relative to something like Dravet? Is there a patient registry, how many patients do you think out there right now and how do you size the opportunity? Thanks so much.

[Stephen Farr:]

Just on the IES we have kicked off an IES, it's actually in Europe not United States in Doose syndrome we don’t have any data from that study as of this time, and are unlikely to get meaningful data by the time that we actually conduct our own randomized controlled trial. I think our excitements around Doose syndrome is the fact that the incidence is about the study in Dravet syndrome it is a childhood epileptic encephalopathy with a difficult to treat seizure feeling type. We do think that our drug could be effective in that, which is why we are looking forward to running study. We are still working on what we hope that market opportunity is and we are running advisory polls right now to really trying to get more information on that. But we do think it’s a meaningful opportunity to pursue with FINTEPLA with good probability and success.

[Operator:]

Our next question is from Tazeen Ahmad from Bank of America. Please go ahead.

[Unidentified Analyst:]

This is Brian filling in for Tazeen this evening. Could you provide more color on your commercial strategy in Europe? Are you thinking positioning your sales force differently compared to your U.S. launch? And I have two more follow ups.

[Stephen Farr:]

I'm going to ask Ashish to address that question for you.

[Ashish Sagrolikar:]

In Europe, in terms of what we are looking at sales team, we will have key account manages in key countries. And as you know, once we get the approval, there will be a sequence of reimbursement decisions. And online sequences primarily based on how we are approaching each country. We plan to commercialize to start with in Germany, France, Italy and UK, and we are looking at other countries as the timeline progresses. But we will have more information on that in few months.

[Unidentified Analyst:]

And are we also expecting any updates from the open label extension 1503 study at the upcoming AAN meeting?

[Stephen Farr:]

Unlikely, there will be anything around that FDA meeting. We are obviously moving forward with a 120 day safety update as part of the NDA submission. So we will have more safety days available and that’s likely to be presented later in the year.

[Unidentified Analyst:]

And one last one on the LGS 1601 study. Is there any chance so we can get there early than what your guide in the first quarter of 2020?

[Stephen Farr:]

No, there's not. We feel confident in Q1 2020. But as we mentioned, the European sites came on with the large majority this quarter. We have seen healthy enrollment in Europe, which is great to see. But we need to give them a quarter or so to get all their patients into the trial. And then remember this is a five to six months study, so when the last patient is enrolled and essentially another five months before the trial will be completed. So that puts I think confidently and firmly into the Q1 timeframe.

[Operator:]

Our next question is from Marc Goodman from SBB Bank. Please go ahead.

[Marc Goodman:]

Yes, few question. First, you mentioned some investigator led studies. I was just curious if you could give us any idea of what types of epilepsy they were working on? Second, Michael, can you give us any flavor for spending for this year? And third, just curious your thoughts on epidiolex and the noise that you've heard so far from it and are there -- do you think it's positive for you guys? Thanks.

[Stephen Farr:]

I'll take your last question first, and that we obviously saw GW's earnings yesterday. So I think it's been very good progress they have made with respect to launch of epidiolex. So we think it's great news for them. It's certainly great news for patients. And we also think it's good news for us. I think it just demonstrates that there is a real unmet medical need in this area and physicians and patients are looking for the new treatment options. And so we think it pays well for us as well as we move forward here. Marc, I'm going to ask Gail to address the question around the initiative studies, and then Mike can follow up on financials.

[Gail Farfel:]

The two studies that have been publicly announced the Doose study in Germany and also there is a U.S. based study in Sunflower syndrome that I believe has kicked off in the most non-clinical trials. We have other protocols under review and we will update the community when move forward efficiently.

[Stephen Farr:]

And then to your question on spending for this year, Mark. We'll have a little bit of a bump up. We'll have some roll-off of expenses due to Dravet completing. But note that we have 90% patients continuing our open label study. And so in effect, a lot of that is an investment in keeping those patients on therapy, and that will also continue to hit our R&D line. So we are not specifically guiding numbers, but we will have a bit of a bump just because the expected launch of activities but nothing in the neighborhood of a large bump up at this stage in terms of the P&L. That said, spending is also applicable to some milestones that we have from our original purchase of the asset from Brabant Pharma. So we will have some payments due for success, I mean some success that we noted today with the MAA being accepted. We will be making some payments related to that deal this coming year if we have continued success with regulatory agencies.

[Operator:]

Our next question is from Danielle Brill from Piper Jaffray. Please go ahead.

[Danielle Brill:]

A couple of follow ups with prior question, regarding the epidiolex launch. I'm curious if it impacted your thinking at all on your commercialization strategy? Are you still planning on the 40% to 50% sales force in the U.S.? And then also a follow up to the EU commercialization strategy, can you remind the number of reps you are planning for there?

[Stephen Farr:]

I'm going to ask Ashish to address both those questions for you.

[Ashish Sagrolikar:]

So in the U.S. based on the launch we really happy to see that the patients have now an option with epidiolex. And we will be looking at sizing out team based on our indication that we have filed for that is Dravet syndrome. And from a sales team what I'm looking at -- what we are looking at as a team is the overall customer facing team approach, which is the key account manager, the reimbursement support team, also the national account team, which will call on the payers plus also from our medical side, the MSL team, which is going to be a part of the footprint in front of the customer. So from a sizing perspective, it will be geared towards in the Dravet community and the prescribers for the rare epilepsies like Dravet. And for the Europe, at this point in time, we do not have guidance on what numbers we will be looking at. But it will be fair to say that as we are looking at in the U.S., it will be geared towards the Dravet patients as well as the Dravet community size in individual countries.

[Operator:]

Our next question is from Jason Butler from JMP Securities. Please go ahead.

[Jason Butler:]

Just one on Doose syndrome. Can you just talk about how you are thinking about the control arm here, or what data you are basing on your assumptions for the background seizure rate in this population? And then secondly, can you talk about the typical background meds these patients were getting, any differences here versus Lennox-Gastaut or Dravet? Or any drug that need to be considered in terms of potentially looking for drug-drug interactions? Thanks.

[Gail Farfel:]

We will talk more about that in the near future. We are still working out the protocol. And so I think it will be more appropriate if we update you at the next call or the next -- over the conversations.

[Stephen Farr:]

Yes, we are still working on the protocol, Jason. We have an expert panel that’s helping us for that protocol. It's coming up fairly shortly. So we will be in a better position to address that question later, as Gail said.

[Jason Butler:]

And then just a quick one on business development priorities. Anything you can say at this point about where your priorities lie versus the execution on the regulatory submissions. Is there something that could fit into the commercial infrastructure at a similar timeframe for the FINTEPLA launch or is this something likely further down the line? Thanks.

[Stephen Farr:]

It's something further down the line. We have an interest in looking at pipeline assets. And Mike mentioned the areas that we are looking at as part of the prepared remarks. So it's rare disorders, which we definitely have I think bias towards neurological rare disorders, but we are also into other rare disorders and we are actually doing diligence on a number of opportunities right now. We feel that we can create more value by bringing something in that’s demonstrated early clinical proof of concept and then will be taken through a formal program. And our thinking is also that to some extent we don’t want to distract our commercial team away from making FINTEPLA successful launch by compiling it with another commercial product. So our strategy is to really find something for our pipeline as opposed to something the commercial team right now.

[Operator:]

Our next question is from Difei Yang from Mizuho Securities. Please go ahead.

[Difei Yang:]

Just on the opportunity in Japan. Would you remind us the prevalence rate for Dravet syndrome in Japan, as well as what's to be done clinically before the drug gets approved? And then finally on the business deal side, would it be a typical upfront plus royalty, do you expect upfront to be a sizable upfront?

[Stephen Farr:]

Mike, do you want to take the last question first?

[Michael Smith:]

So generally, there has been limited studies in Dravet most likely no worldwide, but there has been a couple of published reports for Japan prevalent that put it in the range of anywhere from 1,000 to 3,000 patients. Now whether those are 1,000 to 3,000 patients that are actively diagnosed and are being controlled or not, it's still a question because there hasn’t been a lot of commercial effort focused in the area or a very successful product that has worked very well for those patients. So that’s a general benchmark to go with based on some publications that had come out, and it's hard to validate much more than that at this point publicly. In terms of the path for us on the development side, we plan to leverage our global phase 3 program substantially in collaboration with agreement at effectively the Japan medical agencies. And so we felt that we'd go ahead, agreed, a path for us with respect to a J-NDA that would have some ancillary studies being done and we made patient populations that would bolt-on, if you will, to our global phase 3s and also a small study that will contribute to understanding specifics of PK on the patient populations. But it’s a very leverage path that we are taking based on it being orphan in condition unless having very substantial amount of data already in our global phase 3s. And then in terms of the deal terms in a partnership, I think our main focus is to have a partner who is committed in getting drug to patients. And that can really serve the patient population in a meaningful way, because as we mentioned and you are aware, it has not been a disease that have lot of treatment options historically. And it's an underserved population. And in terms of economics, we would like -- because of that relationship, it will probably relationship that’s important for us to have a fair amount of influence into. And as such, we will be focusing mostly on the downstream economic related to providing product to them and having them market the product and not sharing the profit.

[Operator:]

Our next question is from Yatin Suneja from Guggenheim. Please go ahead.

[Yatin Suneja:]

Could you guys give an update on the combo study that you are running with CBD? Just help us understand when could we see anything from that particular study? Are you using the currently -- is this epidiolex, which is being used? Or do you have your own CBD that you are using there?

[Stephen Farr:]

We actually have two studies, we talked about we have been conducting, exploring the combination of ZX008 with CBD. I want to make the point clear that we have not being using epidiolex as a source of CBD for either of those studies. We did run a formal phase 1 drug-drug interaction study with another commercial source of CBD that phase one trial is complete. We have the data of those data have been submitted with the FDA. We will talk more about those results at the conference coming up later this year. The second trial is really where it’s an investigator initiative study and operated on a few sites in the United States where they are adding the ZX008 to patients who are taking various off seasonal forms of CBD, so again not epidiolex but an off seasonal forms and looking at safety tolerability and the efficacy as well. And we expect that we'll have some data to report from that trial as we go through this year and probably towards the end of year.

[Yatin Suneja:]

And then with regards to the Lennox-Gastaut pivotal trial that you are running 1601. What split you are looking for between U.S and Europe? And could you anticipate any headwinds from enrollment perspective, especially in the U.S. now that epidiolex is available?

[Gail Farfel:]

We started our U.S. sites several months ago and enrollment at a very -- actually exceeded our expectations. As LGS is orphan disorder, there are a finite number of patients at every site. So we do believe that the U.S enrollment has reached its peak, and therefore the availability of epidiolex impacted. We're looking to the ex-U.S. sites, primarily in Europe, which are coming online now to round out enrollment and that will allow us to finish in second half of this year.

[Operator:]

Our next is from Michael Higgins from Ladenburg Thalmann. Please go ahead.

[Unidentified Analyst:]

This is Rui in for Michael. Some of my questions have been answered, but there is still couple of left mostly on enrollment. So one is a follow up on Japan and how enrollment might be going on there, and when do you expect you will be ready to file in Japan? And the second one also enrollment is about the 1601 trial. So LGS, I believe the last update was in December. You mentioned you reached 50% of your target, 225 patients. So you have an update on that where we're at right now?

[Stephen Farr:]

I will ask Gail to address your question. So just one thing, we’re not guiding on the timelines around Japan right now. But I will give you a general update on where we’re at.

[Gail Farfel:]

So generally, we are in the process of starting initiating the sites in Japan for both enrollment in Dravet syndrome and enrollment in LGS there, there are two separate protocols, as Mike said. And so that will be commencing shortly. And with regard to the entire global LGS program, I believe that was your second question. Yes, we have passed the 50% randomized smartly in 2018. And so we’re continued with the same similar enrollment rate, and that allows us to have confidence that we'll complete enrollment in the second half.

[Operator:]

[Operator Instructions] Our next question from Timothy Lugo from William Blair. Please go ahead.

[Myles Minter:]

Hi, Myles on for Tim, thanks for taking the question. I’m just wondering about the differences between how pricing for Dravet syndrome present in the point of contracted clinical sites between the U.S. and Europe? And does that change the top level strategy of where your MSLs are engaging or your cap managers between those two markets, and some extra color on the patient workout would be great there.

[Stephen Farr:]

Based upon our understanding and I think quite frequent interactions now with physicians who take care of Dravet patients in Europe and United States, we don’t see really any real differences in the way these patients are presented and are treated. And out of the way which we've operationalized our clinical programs has been identical in United States and Europe. So we don’t expect there to be any major changes or differences when we enter the commercial ground.

[Myles Minter:]

And just a follow-up with that five one drug-drug interaction study with CBD. I was wondering what your [indiscernible] what's going into that study, did you expect a drug-drug interaction? And would it be related to bio-availability like what we saw with [indiscernible] and ZX008?

[Stephen Farr:]

I mean based upon an in-vitro screen of the potential drug-drug interactions, there was certainly a plausible interaction between CBD and the ZX008 based upon an isoenzyme innovation by CBD. So in other words it would be a change in the metabolism of the product rather than the bio-availability per se. And that’s what we've studied in our drug-drug interaction study. And as I said, we got information, it's in the NDA and we will be presenting that at some point during the year.

[Operator:]

Our final question is from David Sherman from LifeSci Capital. Please go ahead.

[David Sherman:]

Could you just remind us on the seizure burden in Doose syndrome? And then just second question, is the distribution for trial sites expected to be similar spanning U.S. and Europe similar to Dravet and LGS?

[Gail Farfel:]

As we said earlier, David, we are going to speak about the Doose syndrome protocol at our next call. We are in the process of working with our advisors to mark down some of the details and some of the assumptions. So I prefer to talk about this as the next opportunity.

[Stephen Farr:]

David, you had one other question, which…

[David Sherman:]

On the seizure burden for Doose?

[Stephen Farr:]

Yes, it's really as the same. There is an unmet medical need. But they have very frequent Micronic, atonic and seizures and they are very poorly treated by [indiscernible] epileptic drugs. And rather some of these are Dravet syndrome that a sodium channel inhibited drugs, which makes the condition worse, so it is another highly refractory intractable epilepsy in childhood.

[Operator:]

Thank you. This concludes the question-and-answer session. I'd like to turn the floor back to Dr. Farr for any closing comments.

[Stephen Farr:]

So thank you all for joining us on this call today. Obviously, we're in a very exciting moments in our company's history. We are hopefully on the verge of getting the NDA accepted together with the MAA and then moving on for potential future approvals and commercialization. So clearly, we are looking also to expand our business development. Hopefully, we'll have some news around that as we through this year. In summary, we still are in a great spot and thank you again for your questions today and your attention.

[Operator:]

This concludes today’s teleconference. You may disconnect your lines.