ZGNX (2019 - Q3)

Welcome to the Zogenix’s Incorporated Third Quarter 2019 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]. I will turn the call over to your host, Mr. Brian Ritchie from LifeSci Advisors. Please go ahead. Brian Ri

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, Ashish Sagrolikar, Chief Commercial Officer and Dr. Joanne Quan, Chief Medical Officer of Zogenix’s subsidiary, Modis Therapeutics, who 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 third quarter ended September 30, 2019. 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, November 7, 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’d like to turn the call over to Steve.

Thank you, Brian. Good afternoon to everyone who is joining us on today’s call. Later in the third quarter on September 26, we were pleased to announced that we had resubmitted our NDA for FINTEPLA, our lead product candidate for the treatment of seizures associated with Dravet syndrome to the FDA. Accordingly we expect it’s acceptance for filing by the FDA in the early to mid December timeframe, assuming the FINTEPLA NDA is accepted for review and if the FDA grants priority review, our continued target day quickly as soon as the end of the first quarter of 2020. In parallel, our MAA for FINTEPLA for the treatment of seizure associated with Dravet syndrome which was submitted and accepted in early 2019 remained under active review by the European Regulatory authorities. Over the last several quarters we have been actively engaged with review within Europe to assist in their assessment on our application and advanced process towards their final opinion in 2020. As the review of these important regulatory submissions about this, we continue to collaborate with leading experts to further analyze our clinical data set in order to expand the body of evidence in support of FINTEPLA for the treatment of Dravet syndrome. In October, we presented five prognosis at the Childhood Neurology Society Annual Meeting highlighting new data demonstrating long-term, clinically meaningful reduction convulsive seizure frequency and similar development for Dravet syndrome patients both under the age of six. As well as pooled analysis of our two Phase 3 clinical trials that showed clinically meaningful and profound reductions in Generalized Tonic-Clonic Seizures. This type of seizure often causes physical injuries in child as they can fall during the seizure and it is also a recognized refractor for sudden unexplained death in epilepsy or SUDEP. Also in CNS meeting, we shared results of Phase 1 study recently conducted to access the potential drug interaction of FINTEPLA and cannabidiol or CBD. This study shows that the metabolic tracts CBD on FINTEPLA on minimum and unlikely to require a dose adjustment to FINTEPLA, if the drugs are co-administered. This information will be on imposed to physicians when considering combined used of FINTEPLA and CBD for treat seizures in patients, if FINTEPLA is ultimately approved. Looking ahead to the rest of the year, we once again have a strong presence at the upcoming American Epilepsy Society, AES which will take place December 6 through 10 in Baltimore. A total of eight drug test including 3 leg breaker presentations with new data analyses from the Dravet Syndrome clinical program have been accepted for presentation at AES. In addition, we’ll be funding a CME symposium at the conference and will again host a scientific exhibit room on the morning of Sunday, December 8 to highlight many of the data presentations generated from our FINTEPLA program. We’ll also be holding an Investor Update lunch on Monday, December 9 at the AES Meeting. The events will include discussion of the new data presented at the AE Conference and highlight the evolving evidence of long-term neuro cognitive improvements associated seizure reductions demonstrated in the FINTEPLA clinical studies. The Zogenix team will provide an update on US commercial activities in anticipation of the approval launch of FINTEPLA in Dravet syndrome. We will also discuss progress on our other FINTEPLA clinical programs. Meanwhile we’re taking advantage of the time we have leading actual potential product launch to study and assess the emerging dynamics currently taking place in the Dravet community through interactions with key stakeholders. We have been participated in target discussions with caregivers, other key groups, key opinion leaders and treating community physicians in order to obtain a complete view of the important and met needs and challenges that patients and their families face daily. In addition, we continue to hold positive and constructive meeting with players about Dravet syndrome and the FINTEPLA clinical efficacy and Alkins [ph] data generated today. As communicated previously, we’ve also established our specialty pharmacy capabilities to ensure a high level of access of an efficient experience for patients to initiate FINTEPLA therapy. Importantly, we continue to experience strong interest and engagement from the Dravet community in both the open-label extension studies and the early access program. In total, there are over 420 Dravet patients currently being treated with FINTEPLA across these programs. More than 350 of these patients have now been on FINTEPLA for at least one year and are processing 130 for at least two years. We remained encouraged by the efficacy and safety profile being demonstrated by FINTEPLA in these patients over the long-term. Moving to our program for FINTEPLA for the treatment of seizures associated with LGS or Lennox-Gastaut syndrome. We managed in the third quarter that we completed enrolment for Study 1601, the company’s Phase 3 clinical trial. Study 1601 is a global double-blind placebo controlled 3-arm trial and 263 subjects between two and 35 years of age. We are on track to report our top line safety and efficacy data from this trial in the first quarter of 2020. I’d now like to briefly discuss the new Phase 2 exploratory randomized, double-blind, placebo-controlled clinical trial [indiscernible] initiating subjects with rare seizure disorders. This will be an international multi-cohort study in subjects with Doose syndrome, Tuberous sclerosis complex, 215q syndrome [ph], CDKL5 deficiency, mutations in the PCDH19 gene, a mutation in the sodium channel gene that does not need a diagnostic criteria for Dravet syndrome and find new patients between one and three years of age with Dravet syndrome. The study will benchmark seizure ties in each indication for four weeks followed by short-term placebo-controlled period and then a long-term open-label extension. We expect to enroll the first patient into this Phase 2 study in the first quarter of 2020. In addition to achieving further progress while leading FINTEPLA program on the September 9, Zogenix took another major step and its commitment to becoming a leader in developing and commercializing transformative therapies for the rare disease patients and their families while we completed the acquisition of Modis Therapeutics. One of the lead investigational therapeutic candidate MT1621 is in-late stage development for a treatment of devastating Mitochondrial DNA depletion disorder from the bone [ph] deficiency or TK2d. While this disease can effect patients of all ages is more prevalent in infants and young children presenting as progressive and severe muscle weakness that profound impairs movement, breathing, eating and other normal functions. The disease is often fatal and there are currently no approved therapies. MT1621 is an oral fixed-dose combination treatment of deoxycytidine and deoxythymidine that serves as substrate enhancement therapy to restore Mitochondrial DNA to overcome deficits caused by the disease. As a reminder, this investigational therapy has received breakthrough therapy and rare pediatric diseases from the FDA and prime designation from the European Medicines Agency upholds orphan drug designation for the treatment TK2d in the US and in Europe. In early October, the Annual World Muscle Society Congress in Copenhagen we presented key efficacy and safety data from a global retrospective study termed RETRO on the deoxycytidine and deoxythymidine and 38 pediatric and adult patients with Tk2 deficiency. Outcomes from treated patients in this study were compared to a compiled data set of natural history outcomes of 68 untreated patients. The most important results reported from the RETRO study were survival analysis which demonstrated that the difference in probability of survival between treated patients and untreated natural history controlled patients was highly, particularly significant at the PYIO [ph] of less than .00006. All MT1621 treated patients remain alive. In addition, 95% of treated patients are either improved or stabilized responses in the major front end motor, respiratory and feeding domains. A subset of treated patients demonstrated profound efficacy responses in some cases reacquiring previously lot motor milestones including operational ability to walk, breathing independently without mechanical ventilation or other respiratory support and the ability to nourish without our feeding support. Safety findings from the RETRO study indicated that MT1621 withdrawing, safe and well tolerated. The majority of series are verse events related to the underlying disease. Two patients discontinued treatment due to asymptomatic increases and liver enzymes that reverse after study discontinuation. We intent to meet with the FDA during the first half of 2020 to discuss next steps for this exciting program and anticipate providing an update regarding future development plans and regulatory submission timelines once we retain feedback from these discussions. In conclusion, while we wait acceptance for our NDA for FINTEPLA and Dravet syndrome and while our MDMAA remains at active review in Europe. We’re focused on key commercial preparations for launch in both United States and Europe. We also look forward to the availability of Phase 3 data in LGS in the first quarter of next year and to initiating the Phase 2 study for FINTEPLA in multiple rare seizure disorders. We are also very pleased with the recently announced RETRO study results and are preparing to meet with regulatory authorities on MT1621 in the first half of next year. With that, I’ll now turn the call over to Mike, for his review of financials. Mike?

Thanks Steve and good afternoon, everyone. Today we issued a press release summarizing our business and financial results for the quarter ended September 30, 2019 which I’ll now summarize. We recognized $0.6 million in revenue in the third quarter of 2019 and this revenue is result of our March, 2019 strategic distribution partner for FINTEPLA in Japan with Nippon Shinyaku. For which we received upfront payments in the second quarter of $15.5 million for the development activities related to FINTEPLA for the treatment of Dravet syndrome and LGS. Total operating expenses for the third quarter were $294 million. Important to note, that $249.5 million or 85% of this amount was recorded acquired in process, research and development expense, related to the Modis acquisition and MT1621. SG&A expenses for the third quarter ended September 30, 2019 totaled $15.8 million which reflects 43% increase over the third quarter, 2018. Our SG&A expense increase was driven by continued investment in preparation to respectively launch FINTEPLA for the treatment of Dravet syndrome in the United States and in various countries in Europe in the coming years. Net loss for the quarter ended September 30, 2019 was $290.5 million or $6.75 per share and this compares with the net loss of $42.3 million or a $8 per share in the third quarter ended September 30, 2018. Again keeping in mind, that a recorded $249.5 million in profit R&D expense related to the acquisition of Motis and MT1621 is a primary component of those lose amounts. In the first nine months of 2019, net loss was $363.4 million or a net loss $8.54 per share compared with the net loss of $101.5 million or a net loss of $2.78 per share in the nine months ended September 30 in the prior year with again $249.5 million in process R&D charge related to Motis being the primary factor in the amount of loss. We ended the third quarter with cash, cash equivalents and marketable securities totaled $255 million following these $175.5 million for the Motis acquisition which occurred on September 6, 2018. We remain well capitalized and positioned to execute on our strategic plan and bring FINTEPLA market as a potential new treatment option for Dravet syndrome and LGS patients in LATAM and as successfully expanded our late stage pipeline to the acquisition of Motis in MT1621. I’ll now turn the call over to the operator to begin the Q&A session. Operator, can you please provide the instructions?

[Operator Instructions] your first question comes from Paul Matteis with Stifel Nicolaus. Please go ahead.

I was wondering if there’s anything you can tell us about EMA review and whether or not there have been any surprises and whether or not, you’ve discussed the preclinical animal model conversation that came up with FDA in the RTF. I mentioned a couple other, quick other ones. I was wondering if you’ve given any additional FINTEPLA long-term safety aided EMA and if you could comment on that and whether or not it’s a line with last year’s AES presentation and then lastly, I just have one follow-up and I’ll stop talking for a second. Thanks.

Paul thanks for your questions. We expect our interactions with EMA, we have received our Day 120 questions and we’re working towards getting our responses to the reviewers by the end of this year. With respect to the questions that we received, they were right across the gamut of the sections of the submissions clinical, non-clinical and CMC and nothing that’s – was pertained to us having to generate more data, so really nothing surprising, I would say in our interactions to-date. Gail, anything you would like to add to that?

Only that the data that we presented to the EMA with regard to your question about long-term safety and is the same set we have talked about, I believe at AES and have provided to the FDA.

And Paul just again on the long-term safety. We obviously move forward with an analysis of open-label extension data that self [ph] expired Day 126 requirement so that will be a larger data set with more patients and obviously longer durations of exposure and we’ll be probably reporting on that publicly, once it’s being submitted to the FDA.

Okay, next. And then on the IFT [ph] is that’s something we could see some data from next year, how many patients do you think might be in that? I’m referring to the study indusa [ph] and TSA. Thanks.

Go ahead, Gail.

So there’s a company sponsored trial and also we’re enrolling across seven different indications and the indications will be in line individually so our hope is that, we get enough patients in at least one of the seven indications, if not more to be able to give an analysis of one or more of the indications late in 2020.

Okay, great. Thanks so much.

Thank you. Your next question comes from Marc Goodman with SVB Leerink. Please go ahead.

So first of all, can you talk about the CBD trial that you presented at the meeting, just recently? What type of feedback you got from the physicians, do they feel like they understand how to use the products together, you mentioned something about having to adjust dosing, what exactly do you think are the learning’s that we got there? That’s number one. And then second of all, you talked about commercial preparations. But, would you mind just going through again, where we are and what exactly you’ve done with respect to [indiscernible] commercially for the US and then also talk about some of the payer interactions and whether the pricing that you kind of hinted at to everybody is okay, with the payers and they’re kind of giving you positive feedback that can work. Thank you.

Thank you, Marc. I’ll address the CBD trial first and then ask Ashish to comment on our commercial preparation. So the CBD trial, it was a Phase 1 study and healthy volunteers. We conducted in order to – been able to get better perspective on whether or not there was a plausible drug interaction between FINTEPLA and CBD recognizing there are a CBD. There’s a FDA approved CBD product [indiscernible] market as well as use of artisanal CBD by this patient population. At the time that we conducted [indiscernible] study [indiscernible] for us to use as part of the trial so we actually used – in this study kind of using a government approved form of CBD and used that in our trial. The take home from that is that, that the CBD whilst they’ve had a plausible invitro effect on the metabolism of [indiscernible] FINTEPLA, it didn’t raise to the level in our Phase 1 trial do something to worry about with respect to dose adjustments of FINTEPLA [indiscernible] products were used together. So the bottom line for us is that, if we had a question and from a position about using the two products together and whether or not it will be quite over adjustment we could go back and basically say, they would noted those adjustments required for FINTEPLA and [indiscernible] use from LCV [ph] data. We think it’s very worthwhile and appropriate study to do, to provide that information to physicians who may prescribe FINTEPLA once it’s approved. Ashish?

So Marc, I think if you go through some of themes from a commercial perspective let’s start with you question on the pair interaction. We are continue to having a very constructive conversation with payers and we’ve started familiarizing them with clinical efficacy safety profile and we have received very positive reception to the outcome data FINTEPLA has shown in the trials. Earlier in the year, we did initiate development of outcome models with input from customers which includes payers and all over constituency and we hope to continue having that dialog in Q4 as well as in Q1 as we prepare for launch. From a preparation perspective, as we said earlier the specialty pharmacy operation space up and running, current early access program is being run through that. So we’re giving a phenomenal experience of how will we fulfill the orders and how do we manage the interaction when we get approval and launch it. We also have higher individual market access function which includes in the national accounts, who are calling on payer obviously as this point in time and in preparation of kind of being ready once we’re closer to launch to put all the other infrastructure in the ground which includes the reimbursement support and all the support that the patients need. We did [indiscernible] in the year, they do have a combined more than 40 years of experience in Epilepsy market. We have also hired couple of key account managers and we continue to hire them in key areas because as you recall, we undertook a very extensive exercise of profiling the accounts where the Dravet patients are actually currently being treated and we’re now introducing ourselves and getting to know what the processes are, so that when we receive approval and when we launch it, we will have a clear path and a process to manage it. Finally on pricing, we have not yet finalized the pricing for FINTEPLA and we will be talking about disclosing that towards the approval and around the launch timeframe. But as we’re considering pricing, we’ll carefully review a few factors of first year’s optimizing patient [indiscernible]. Second the size of Dravet syndrome population because that’s the indication where we’ll be launching it first. From outcomes that, we have seen the clinical trial, but we do believe that it will deliver to patients and finally the ability for us Zogenix to make a fair run and based on the outcomes that FINTEPLA has demonstrated, we do believe that it will deliver value to patients there and they help get system relative to other therapies.

Just lastly on the pricing I realized that you haven’t set pricing yet, but I’m sure your interactions with the payers are in a range of pricing and I was just curious if the feedback from them and given the outcomes data, you said them is relatively okay, you still feel good about the range that we’ve been talking about for the past year.

At this point in time, we do feel good about the range, but as you know, we will have, we haven’t really had these detailed conversations in terms of specific pricing because as I said earlier we will not be disclosing it till we receive the approval or around the time of approval of launch.

Great, thanks.

Thank you. Your next question comes from Danielle Brill with Piper Jaffray. Please go ahead.

This is Nirav on for Danielle. Thanks for taking my questions. I just had a couple, the first one was, I was wondering if you heard any feedback from doctors about any sort of burden that in-house monitoring might cause and if you done some analysis to see how many of your target prescribers have in-house capabilities?

Yes, I’ll ask Ashish to address that one for you.

Yes, so we in our advisory boards and the conversations with the physicians, what we have discovered that, doing monitoring is for patients with Dravet syndrome is fairly common and there’s a lot of testing that goes on. We do realize that when approved, if we have to do the monitoring we are putting together infrastructure with our specialty pharmacy or also hub to help them for the process and to that effect, we have conducted multiple workshops and advisory meetings with families, parents as well as physicians to really think through how we can help them, but how we can make system much more easier to manage. So we feel very comfortable that we now have a plan that we can address with. Nirav, can you please repeat your second question about target prescribers?

Yes, I was just wondering how many of your target prescribers would have in-house capabilities to do monitoring in-house?

It will depend on where they are located. If they’re at the institute or at a hospital, they will have that in-house capability where they can just take them on the hall or other floor. But what we feel comfortable is in terms of the target population of where you have epilepsy centers. I would sell most 30% to 40% of them would have that [indiscernible] capability in the initial stages and as we get into the community settings. We will working to help, how we manage the entire process.

Got it. Thank you. Last question it’s just a quick follow-up on a previous question I was asked. In regards to pricing specifically in your interactions with payers or any market research you’ve done, have you seen any indication one way or another of how adoption might be impacted, if it is, if FINTEPLA is priced at a significant premium to Epidiolex.

Nirav given the sensitivity and when the what comes to the price, it’s really difficult to comment on that at this point. But when we look at the overall value the feedback we’ve gotten on the value that we provide from the clinical as well as outcome perspective has been very positive and I think that’s what I would be comfortable saying at this point in time.

Okay, great. Thanks, that’s helpful. Thank you guys for the question.

Thank you. Your next question comes from Jason Butler with JMP Securities. Please go ahead.

We had a few about them, the Motis acquisition. I think when you announced the acquisition you’re still detailing the commercial opportunity. Do you have any updates you can share on that? And then the single escalation dose PK trial, anything you’ve learned from that trial and yet and then, the last question can you share any timing about plans for discussions with the EU regulators for MT1621. Thanks.

Thank you for your question. I could ask Joanne to address those for you.

Sorry, could you repeat the first question – you had several questions there. I just want to make sure I understood it.

Yes, sorry will do it quickly. The commercial opportunity you guys were still working on it, I think when you announced the acquisition. Anything you can share around that?

Yes, I’ll have Steve for address that.

Yes, I’ll address that one and then Joanne I think you have two clinical question, that you wanted it. We’re still obviously working on that right now with respect to commercial opportunity. But we have data that shows from looking at hematological data that’s anywhere between 650 and 2,500 patients in United States that could suffer from this disorder. We’re doing work now from a more bottoms up approach to get a better number on that, that work is ongoing, we continue to – will do that next year. As we conclude the clinical development. So we do think that, this is one of the disorders where as a drug becomes available and there’s more awareness about the drug and the disease itself, we’re likely to see an increase in the number of patients who are diagnosed with TK2 deficiency. And Joanne, do you want to? Go ahead, Jason.

The PK trial, anything you’ve learned from that, that you can share with us and just plans on timing for discussions with the EU regulator.

So the PK trial has been completed although we’re still analyzing the data, so we’ve not released that just yet. In terms of discussions with regulators I think Steve mentioned earlier that we’re planning to meet with the FDA in the first half of 2020 and we made discussions to follow that, so a bit later than that.

Okay, thank you.

Thank you. [Operator Instructions] your next question comes from Yatin Suneja with Guggenheim. Please go ahead.

Question on the commercial front, would you anticipate any sort of EEG or MRI confirmation for the diagnosis for Dravet or do you think just the clinical diagnosis is enough for the drug to be prescribed and could you maybe remind us, if that was one of the requirement for the clinical trials that you conducted to screen Dravet patients?

Thanks for your questions. No it’s simply a clinical diagnosis and that’s exactly what we use in our Phase 3 trial, so putting no differences in what we did in our Phase 3 trial relative to the way which Dravet is diagnosed in the forward patient population.

Got it, thank you. And then just another question on the new Phase 2 trial in rare disorders or rare seizures that you’re going after. Can you maybe help us understand like how are you sort of trying to prioritize the indications more indications or is it there, particular type of seizures that you going to go after and how can you expedite the development in other epilepsy outside Dravet and Lennox-Gastaut?

Yes, I think the purpose of the Phase 2 trial is single TK study where we – how the drug performs in variety of rare disorders and while we’re doing this in individual studies to do more vascular approach. So it’s really that the outcome we’re looking for in this study is to see where the drug works effectively and then consider what the next steps would be thereafter.

Got it and then final question on the P&L, maybe if you can help us model the expenses going forward. Do you think the R&D is going to shape up given that both the Lennox-Gastaut trial will sort of conclude sometime early next year. Thank you.

Mike, would you like to address that question?

Yes, sure. Yes, we’re speaking for the immediate future and we can give you qualitative call on that, but guidance specifically as yet for financials for next year. But, one thing to keep in mind is that our – are probably our most expensive study right now is combined set of studies where we’re allowing patients to continue on therapy and open-label program where we have over 400 patients being treated and ongoing basis. Now some of those patients are going to shift out as, if we’re able to get approval but LGS program will not be eligibility get approval next year. So we’ll have some of those expenses continuing in some substance ration but we’re going to have a drop of our currently operating go Phase 3 run out some of the Dravet patient, so we don’t see going up too much or down next year. It’s kind of the qualitative guidance we give at this point.

Okay and then can you clarify the exact cash that you have, I mean I see in the balance sheet there’s about $25 million in escrow is that money going to go away or is that just parked right now?

So that’s related to true up related to the transactions that could – I mean there’s currently in office liability with respect to that on our balance sheet, from accounting perspective or reasonably it’s not going to go into our pocket, but we have $250 million plus as of 9/30/2019.

Got it, thank you very much.

Thank you. Your next question comes from Serge Belanger with Needham and Company. Please go ahead.

So in terms of FINTEPLA, I think the NDA submissions are upcoming, how confident are you that the FDA will accept it by mid-December and getting a prior review and has there been any feedback for update from the FDA, whether do you still need to conduct the additional talk study. I think it was from the RTF earlier and then, in terms of the quality of life benefits that you saw in Study 1 and 1504, NDS patients. So given these data, is there any plan to perhaps potentially target neurobehavior indications in the future for example ASP and things like. Thank you.

This is Gail, so we did resubmit in late September and we are looking forward to hearing shortly if the FDA is going to accept the filing, we expect that to be late November, very early December. We are hopeful that we will be eligible for priority review. With regard to the toxicology study that was your question in the – we met with the FDA in a Type A meeting several months and we came to agreement that study was not required for resubmissions. And your last question about quality of life data, our current focus is to look at other epilepsy encephalopathy, we talked about the signal seeking Phase 2 study that we’re beginning to look for signal over strong efficacy in one of those things. We currently don’t have a target of booking in the broader neurobehavioral landscape but you bring up a good question.

Okay, great. Thank you.

Thank you. Your next question comes from Tim Lugo with William Blair. Please go ahead.

This is [indiscernible], thanks for taking the question. You mentioned in some of sort of your pre-commercialization work you’ve been doing, you’ve been looking at the changing dynamics in Dravet market. Could you provide any more color on that and then second of all, you mentioned you’ve got I think it was 130 patients that have been on FINTEPLA for greater than two years. Can you provide any update on what you’re seeing with those patients so your ability of efficacy and is there, I guess are there plans to publish that data or at least in some capacity.

Yes, we’ll soon be publishing more data but right now, our focus clearly is in supporting the NDA and [indiscernible]. In particular providing more safety data to the NDA is part of the Day 120 update. So we will intend course of moving forward publishing the data with respect to both long-term efficacy as well as long-term safety in the future. I think at a high level we’re very pleased with what we’re seeing coming out of our long-term studies as we no change in conclusions from what we’ve already discussed and presented at the AES conferences. But, we will certainly be providing those updates, once they’re available. Ashish, can you address the commercial question?

Yes, I think you can quite frankly find it out that there’s a lot of changes in the Dravet market and the Dravet community is undergoing significant dynamics. Two years ago there were no indicative therapies now there are two and when FINTEPLA will be approved. There will be three by middle of next year and we do expect that, as more therapies are coming in the market. I think physicians will have more confidence, but also be able to control the seizures with either or providing on the combination of cards. I think what underlying fact here is that, with three service is coming up and what we’re hearing from not only the physicians, but patients and the community is, there is a significant unmet need even having two products in the market at this point in time in terms of having a satisfactory feeling control. And there is a need for different therapies because as you know it doesn’t work for everyone, so we do feel very confident that when we launch it I think we will have the good reception in terms of helping patients who are suffering from Dravet. I hope that answers your questions.

Yes, it does. Thank you.

Thank you. Your next question is a follow-up question from Paul Matteis with Stifel. Please go ahead.

Thank you so much for taking the follow-up. I just wanted to ask one quick question on the long-term safety data. During some past calls, you’ve reiterated that through just interim looks you haven’t seen any instances of valvular heart disease or pulmonary arterial hypertension. I was wondering if you were in a position to reiterate that this evening or if the next kind of look or data analysis is being specifically done through regulators, so you’re more reluctant, any color would be great. Thanks.

Yes, we’re happy to reiterate what we said all along, Paul. No incidents of valvular heart disease or pulmonary arterial hypertension.

Fantastic. Thanks Steve.

Thank you. We’ve reached the end of the question-and-answer session and I will now turn the call over to Dr. Stephen Farr for closing remark.

Thank you very much operator and thank you all for joining us on today’s call. We’re extremely pleased with progress we made this call with FINTEPLA and both Dravet syndrome as well as LGS and also MT1621 program in TK2 deficiency. Looking forward to the ending this year with a success at AES Meeting and we hope many of you will be able to return and see our posters there and obviously attend our investor conference as well. So thank you us on today’s call. Enjoy the rest of the day. Good bye.

This concludes today’s conference and you may now disconnect your lines at this time. Thank you for your participation.