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Zogenix Inc  (NASDAQ:ZGNX)
Q4 2018 Earnings Conference Call
Feb. 28, 2019, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

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'll now turn the conference over to your host, Brian Ritchie. Thank you, you may begin.

Brian Ritchie -- Managing Director

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; Chief and 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' 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, 2018. So 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'd like to turn the call over to Steve.

Stephen J. Farr -- President and Chief Executive Officer

Thank you, Brian, and good afternoon to everyone who's joining us on today's call. I'm very pleased to be speaking to you today, to recap, a landmark year in 2018 for Zogenix and to outline our planned activities for continuing momentum for the company in 2019. During the past year, we announced highly positive results from our second global Phase III 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 III study have position the company to advance the preparation of NDA and MAA submissions, in pursuit of our first indication Dravet syndrome. I'll say more about these data in submission shortly.

In 2018, we also continue to advance the ZX008 through a single, global Phase III trial in our second planned indication, Lennox-Gastaut syndrome or LGS. LGS like to Dravet syndrome is a difficult to treat childhood-onset epileptic encephalopathy for which new and more effective treatments are 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 III trial readouts, 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 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 US 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'm pleased to report that the EMA has now accepted our MAA for review and we anticipate that an approvability decision could be reached by the EMA in the first quarter of 2020.

We expect to hear 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 FINTEPLA 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'd like to take a moment to extend my sincere thanks to the patients and families, investigators and the staff, and other experts who participated in the ZX008 clinical trial program over the last four years. I'd also like to recognize all of my colleagues at Zogenix, who have worked so diligently to make these submissions, a reality.

With the data and a change in our clinical Phase III program, we firmly believe Fintepla has the potential to be a compelling treatment option for Dravet Syndrome. The regulatory applications, United States and Europe are based on data from the two pivotal Phase III 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 that 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 will also sustain 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. And fortunately an intensive, perspective cardiovascular monitoring program, shows that no patient developed a volatile heart disease or probably hypertension at anytime during Study participation. Some of these data were presented 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 the United States and Europe, through our own commercial teams. In Japan, we plan to commercialize via a 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 products. 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 fortunate to attract talented sales leaders, marketing the market access professionals with specific experience in Epilepsy and rare diseases. As we move closer to potential approvals, United States and Europe, we have our market access team 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 operation is up and running, we have launched an early access program through key Dravet Syndrome centers of excellence and our specialty pharmacy is providing FINTEPLA to participants in this early access program. This provides us with an opportunity to learn and refine our processes, which will help us make FINTEPLA available to patients seamlessly when approved in the United States and Europe. Now I'd like to switch back to clinical development and discuss Study 1601, our ongoing global Phase III 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 continue to anticipate the completion of 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've already accomplished one key objective for the year with the completion of our NDA and MAA submissions 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 for filing of the NDA on receiving at the 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 in 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 multi-center, 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 request related to other epileptic encephalopathy and difficult to treat epilepsy syndromes. While we do not intend to provide update on these studies till data are available, we think the prevalence of these investigated, initiated studies requests further highlights the potential of FINTEPLA.

With that, I'll now turn the call over to Mike for his review of the financials. Mike?

Michael P. Smith -- Executive Vice President, Chief Financial Officer, Treasurer and Secretary

Thanks, Steve. I will begin by reviewing our three months financial results for the quarter ended December 31, 2018, as compared to the corresponding period in 2017.

R&D expenses for the fourth quarter 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 US 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 a treatment for Dravet syndrome in the US 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 compares with total revenues of $9.8 million in the 12 month 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 31, 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 with a 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 our strategic plan to become a leading rare disease company and create significant long-term shareholder value.

We remain focused on advancing our commercialization plans for FINTEPLA simultaneously, we continue to enroll patients in our second Phase III program in LGS and are preparing to initiate a global multi-center, placebo-controlled trial induced Doose Syndrome. Beyond FINTEPLA, we remain active in business development and continue to evaluate additional product development opportunities that could further leverage our core competencies 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 the opportunity to continue 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.

Questions and Answers:

Operator

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

Paul Matteis -- Stifel Nicolaus -- Analyst

Great, thank you so much for the question and congrats on all the progress. On the US 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 J. Farr -- President and Chief Executive Officer

Thanks, Paul. This is Steve. We did obviously apply for priority review as part of our NDA submission 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 the FDA's decision and we -- and obviously didn't have get any clarity on that with respect or 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 share about the same time around whether or not there's is an outcome. I will say we are planning for one, especially prior to review cycle, and then obviously there's 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 last year and we continued that aggressively this year.

Paul Matteis -- Stifel Nicolaus -- Analyst

Okay, great. Thanks, Steve. 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 or any indication that this indication has -- has a good success?

And then secondarily, maybe if you help or if you could just comment on how to developed this market relative to something like Dravet. Is there a patient registry, how many patients do you think, are out there right now and how do you kind of size the opportunity? Thanks so much.

Stephen J. Farr -- President and Chief Executive Officer

Great. Just on the IES, we have kicked off an IES. It's actually in Europe, not in United States in Doose syndrome. We don't have any data from that study as of this time and unlikely to get meaningful data by the time that we actually conduct our own randomized controlled trial. And 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're looking forward to running study. We are still working on what we hope that market opportunity is and we were running advisory boards right now to really trying to bring more information on that. But we do think, it's a meaningful opportunity to pursue with FINTEPLA with a good probability and success.

Paul Matteis -- Stifel Nicolaus -- Analyst

Great, thanks so much.

Stephen J. Farr -- President and Chief Executive Officer

Thank you, Paul.

Operator

The next question is from Tazeen Ahmad from Bank of America.

Brian -- Bank of America Merrill Lynch -- Analyst

Hi, Steve. This is Brian filling in Tazeen this evening. Thank you for taking my questions and congrats on the progress so far. Could you provide more color on your commercial strategy in Europe? Are you thinking about positioning your sales force differently compared to your US launch? And I have two more follow-up.

Stephen J. Farr -- President and Chief Executive Officer

Thank you, Brian. I'm going to ask a Ashish to address that question for you.

Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer

Thanks, Steve. In the Europe what -- in terms of what we are sales team, we will have key account managers 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 within 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.

Brian -- Bank of America Merrill Lynch -- Analyst

And -- are as we also expecting any updates from the open label extension 1503 Study at the upcoming ANN meeting?

Stephen J. Farr -- President and Chief Executive Officer

Unlikely there will be anything around that FDA AAN meeting and 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.

Brian -- Bank of America Merrill Lynch -- Analyst

Okay. And one last one on LGS 1601 Study, is there any chance that we can get data earlier than what you guided in the first quarter of 2020?

Stephen J. Farr -- President and Chief Executive Officer

No, there's is not. We feel confident in Q1 2020. But as we mentioned, with the European sites came on with the large majority this quarter, we have seen healthy enrollments 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 it's essentially another five months before that the trial will be completed. So that puts us, I think confidently and firmly into the Q1 timeframe.

Brian -- Bank of America Merrill Lynch -- Analyst

Great. Thank you so much. And that was very helpful, thanks.

Stephen J. Farr -- President and Chief Executive Officer

Thank you. Brian.

Operator

Our next question is from Marc Goodman from SVB Leerink. Please go head.

Marc Goodman -- SVB Leerink -- Analyst

Yes. Few questions. 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 whether you think it's positive for you guys? Thanks.

Stephen J. Farr -- President and Chief Executive Officer

I'll take your last question first. And that we obviously saw GW's earnings yesterday and so I think, a very good progress they've 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 not -- 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 initiatives studies? And then Mike can follow up with financials.

Gail M. Farfel -- Executive Vice President and Chief Development Officer

Thanks, Steve. Two studies that have been publicly announced, the Doose study in Germany and also there is a US-based study in Sunflower syndrome that I believe has kicked off in the most non-clinicaltrials.gov. We have other protocols under review and we will update the community when they move forward officially.

Michael P. Smith -- Executive Vice President, Chief Financial Officer, Treasurer and Secretary

And then to your question on spending for this year Marc, we will have a little bit of a bump up, we will have some roll-off of extensive 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're not specifically guiding numbers, but we'll have a bit of a bump up 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.and so we will have some payments due for success and we have 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 had continued success with regulatory agencies.

Marc Goodman -- SVB Leerink -- Analyst

Thanks.

Operator

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

Danielle Brill -- Piper Jaffray -- Analyst

Hi, guys. Thanks so much for the questions. A couple of follow ups with prior questions. 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 US. And then also a follow-up to the EU commercialization strategy, can you remind me the number of reps you're planning for there?

Stephen J. Farr -- President and Chief Executive Officer

Thanks, Danielle. I'm going to ask Ashish to address both of those questions for you.

Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer

Yes, so in the US based on the launch, as Steve said, we are really happy to see that the patients have now -- have an option with Epidiolex. And we will be looking at sizing our team based on our indications that we have filed for that in 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 managers that 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 toward serving 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 a guidance on what kind of that numbers we will be looking at, but it will be fair to say that as we are looking at in the US, it will be geared toward the Dravet patients as well as the Dravet community size in individual countries.

Danielle Brill -- Piper Jaffray -- Analyst

Got it. Thank you for the clarity.

Operator

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

Jason Butler -- JMP Securities -- Analyst

Hi, thanks for taking the question. Just one on syndrome. Can you just talk about how you're thinking about the control arm here or what data you're basing on your assumptions for the background seizure rate in this population.

And then secondly, can you talk about the typical background that these patients are getting, any differences here versus Lennox-Gastaut or Dravet or any drugs that need to be considered in terms of potentially looking for Drug-Drug interactions? Thanks.

Gail M. Farfel -- Executive Vice President and Chief Development Officer

Sure. Hi, Jason, it's Gail. We -- we'll talk more about that in the near future, we are still working out the protocol. And so I think, it be more appropriate, if we update you at the next, with in the next call or the next public conversation.

Stephen J. Farr -- President and Chief Executive Officer

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

Jason Butler -- JMP Securities -- Analyst

Okay, great. 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 in a similar timeframe to for the FINTEPLA launch or is this something likely further down the line? Thanks.

Stephen J. Farr -- President and Chief Executive Officer

Yes, it's something further down the line. We have an interest in looking at pipeline assets. And Mike mentioned the areas that we're looking at as part of the prepared remarks, so it's rare disorders, which definitely have, I think bias toward 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 and that's as demonstrated early clinical proof of concept and then really take it through a formal development program. And our thinking is also that to some extent you 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 with the commercial team right now.

Jason Butler -- JMP Securities -- Analyst

Great Thanks for taking the questions.

Stephen J. Farr -- President and Chief Executive Officer

Thank you.

Operator

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

Difei Yang -- Mizuho Securities -- Analyst

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

Stephen J. Farr -- President and Chief Executive Officer

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

Michael P. Smith -- Executive Vice President, Chief Financial Officer, Treasurer and Secretary

Sure thing. In clear containment here as well with some input if I missed something. Good questions, Difei. So generally there has been limited studies in Dravet, most likely know worldwide. But there has been a couple of published reports for Japan prevalent, put it in the range of anywhere from 1 to 3,000 patients. Now whether those are 1 to 3,000 patients that are actively diagnosed in our deemed control, they're not, it's still kind of a question because there hasn't been a lot of commercial efforts focused in the area or a very successful product that has worked very well for those patients. So that's kind of a general benchmark to go with based on some publications that have come out and it's hard to validate and much more than that at this point publicly.

In terms of the path for us on the development side, we've plan to leverage our global Phase III program substantially with the -- in collaboration with -- agreement with the 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 in EMEA patient populations that would bolt-on, if you will, to our global Phase III's and also be good -- a small study that would contribute understanding specifics like PK on the patient population, but it's a very leveraged path that we're taking based on that being orphan condition, unless having very substantial amount of data already in a global Phase III.

And then in terms of a 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 it is a -- as we've kind of mentioned and you're aware of it, has not been a disease, that's gotten a lot of treatment options historically and it's an underserved population. And in terms of economics, we'd like, because of that relationship it will probably be a relationship that's important for us to have a fair amount of influence into and as such, we'll will be focusing mostly on the downstream economics related to providing product to them and having them market the product and not sharing the profits.

Difei Yang -- Mizuho Securities -- Analyst

Thank you, Michael. Thank you.

Operator

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

Yatin Suneja -- Guggenheim -- Analyst

Hi, Guys, thanks, for taking my question. 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 current -- is this Epidiolex which has being used? Or do you have your own CBD that -- that's you're using there.

Stephen J. Farr -- President and Chief Executive Officer

Yes, thanks for your questions. We actually have two studies, that we've talked about that we've been conducting, exploring the combination of ZX008 with CBD, I want to make the points share that we've not been using Epidiolex as the source of CBD for either of those studies. We did run a formal Phase I drug interaction study with another commercial source of CBD, that Phase I trial is complete. We have the dates of those, data have been submitted with the NDA and we'll talk more about those results at a conference coming up later this year.

The second trial is really where we're, where -- it's an investigator initiative study, and operated out a few sites in the United States, where they are adding ZX008 to patients who are taking various seasonal forms of CBD. So again not Epidiolex but yet an seasonal forms. And looking at safety, tolerability and efficacy as well and we expect that we'll have some basic report from that trial as we go through this year and probably toward the end of the year.

Yatin Suneja -- Guggenheim -- Analyst

Got it, thanks. And then with regards to the Lennox-Gastaut pivotal trial that we are running 1601. In what sort of split you are looking for between US and Europe and could you anticipate any sort of headwinds from enrollment perspective, especially in the US now that Epidiolex is available.

Stephen J. Farr -- President and Chief Executive Officer

Gail?

Gail M. Farfel -- Executive Vice President and Chief Development Officer

We started our US sites several months ago and enrollment was at a very brisk rate that it actually exceeded our expectations as LGS isn't orphan disorder. There are a finite number of patients with every site. So we do believe that the US enrollment has reached its peak and therefore the availability of Epidiolex impacted. We're looking to the ex-US sites, primarily in Europe to which are coming online. Now to round out enrollment and that will allow us to finish in the second half of this year.

Yatin Suneja -- Guggenheim -- Analyst

Great, thank you very much.

Stephen J. Farr -- President and Chief Executive Officer

Thank you, Yatin.

Operator

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

Rui Pedro Capelo de Abreu Galvao -- Ladenburg Thalmann & Co. Inc. -- Analyst

Hi, thanks for taking the call. This is Rui in for Michael. Some of my questions have been answered but there is still a couple of left mostly on enrollments. So, one is a follow-up on Japan and how enrollment might be going on there and when do you expect you'll be ready to file in Japan?

And the second one also about enrollment is about the 1601 trial so LGS. I believe, the last update was in December, and you mentioned you reached 50% of your target 225 patients. Do you have an update on that where we're at right now. Thank you.

Stephen J. Farr -- President and Chief Executive Officer

Yes, I'll ask Gail to address your question. But just one thing, we are not guiding on sort of the timelines around Japan right now, but I will ask Gail, give you a general update on where we are at.

Gail M. Farfel -- Executive Vice President and Chief Development Officer

Sure. 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 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 partly in 2018. And so we are continued with the same similar enrollment rate and that allows us to have confidence that we will conclude enrollment in the second half.

Rui Pedro Capelo de Abreu Galvao -- Ladenburg Thalmann & Co. Inc. -- Analyst

Okay, thank you very much.

Stephen J. Farr -- President and Chief Executive Officer

Thank you.

Operator

(Operator Instructions). Our next question is from Timothy Lugo from William Blair. Please go ahead.

Myles Minter -- William Blair -- Analyst

This is Myles (ph) on for Tim. Thanks for taking the questions. I'm just wondering about the differences between how patients with Dravet syndrome present and there sort of point of contact to clinical centers between the US and Europe. And does that sort of trying to the top level strategy of where your MSLs are engaging your account managers between those two markets. Yes, some extra color on the patient's worker would be great.

Stephen J. Farr -- President and Chief Executive Officer

Myles, this is Steve, we -- based upon our understanding and I think, quite frequent interactions now with physicians to take care of Dravet, patients in Europe and the United States. We don't see really any real differences in the way of these patients are presented are now treated. And out the way in which we've operationalized our clinical programs 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 around.

Myles Minter -- William Blair -- Analyst

Okay, great. And just a follow-up with that five one drug-drug interaction study with CBD. I was wondering what your hypothesis was (inaudible) 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 (inaudible) and ZX008?

Stephen J. Farr -- President and Chief Executive Officer

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.

Myles Minter -- William Blair -- Analyst

Thanks for the color. Congrats.

Stephen J. Farr -- President and Chief Executive Officer

Thanks, Myles.

Operator

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

David Sherman -- LifeSci Capital -- Analyst

Hi guys. 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 US and Europe similar to Dravet and LGS?

Gail M. Farfel -- Executive Vice President and Chief Development Officer

As we said earlier, David, this is, Gail. 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.

David Sherman -- LifeSci Capital -- Analyst

Okay.

Stephen J. Farr -- President and Chief Executive Officer

David, you had one other question, which I'll --

David Sherman -- LifeSci Capital -- Analyst

Yeah, just on the seizure burden for Doose?

Stephen J. Farr -- President and Chief Executive Officer

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 (inaudible) the epileptic drugs. And rather some of these are Dravet syndrome that a certain sodium channel inhibited drugs, which makes the condition worse, so it is another highly refractory intractable epilepsy in childhood.

David Sherman -- LifeSci Capital -- Analyst

Got it. Okay, thanks a lot.

Stephen J. Farr -- President and Chief Executive Officer

Thank you.

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 J. Farr -- President and Chief Executive Officer

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. Thank you again for your participation.

Duration: 43 minutes

Call participants:

Brian Ritchie -- Managing Director

Stephen J. Farr -- President and Chief Executive Officer

Michael P. Smith -- Executive Vice President, Chief Financial Officer, Treasurer and Secretary

Paul Matteis -- Stifel Nicolaus -- Analyst

Brian -- Bank of America Merrill Lynch -- Analyst

Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer

Marc Goodman -- SVB Leerink -- Analyst

Gail M. Farfel -- Executive Vice President and Chief Development Officer

Danielle Brill -- Piper Jaffray -- Analyst

Jason Butler -- JMP Securities -- Analyst

Difei Yang -- Mizuho Securities -- Analyst

Yatin Suneja -- Guggenheim -- Analyst

Rui Pedro Capelo de Abreu Galvao -- Ladenburg Thalmann & Co. Inc. -- Analyst

Myles Minter -- William Blair -- Analyst

David Sherman -- LifeSci Capital -- Analyst

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