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Zogenix Inc (ZGNX)
Q2Â 2020 Earnings Call
Aug 5, 2020, 4:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good day, and welcome to the Zogenix Second Quarter 2020 Earnings Call. Today's conference is being recorded.
At this time, I would like to turn the conference over to Brian Ritchie, LifeSci Advisors. Please go ahead.
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 Commercial Officer, Ashish Sagrolikar; and Chief Financial Officer, Michael Smith; as well as Dr. Joanne Quan, Chief Medical Officer of Modis Therapeutics, a Zogenix company.
This afternoon, Zogenix issued a news release providing a business update, announcing financial results for the second quarter ended June 30th, 2020. 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' press release issued today and the company's 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, August 5th, 2020. 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. Go ahead, Steve.
Stephen J. Farr -- President and Chief Executive Officer
Thank you, Brian, and good afternoon to everyone. We ended the previous quarter with the great news that FINTEPLA had received FDA approval for the treatment of seizures associated with Dravet Syndrome. This is our first drug approval since we pivoted our strategy to focus on developing and commercializing transformative therapies for rare diseases, and as a result of the tremendous work and dedication of all my colleagues at Zogenix. Once again, I would like to thank the patients, families and investigators, who participated in our clinical program for all they have done to help us achieve this tremendous milestone. This approval has enabled us to enter the third quarter as a fully integrated commercial biopharmaceutical company. The official US launch of FINTEPLA occurred last week, on July 27, and we are excited that commercial product has been shipped in the first patient's enrolled into our REMS program.
Ashish will provide an update on our early launch progress and commercial activities. And I'll come back to discuss our ongoing development programs before Mike concludes with our financials for the quarter. Ashish, it's over to you.
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
Thank you, Steve. I'm excited to share our initial progress on the launch of FINTEPLA in the US, which is going extremely well, following the FDA approval on June 25th. Since then, we continue to see a very high level of enthusiasm for FINTEPLA from both physicians and caregivers, reflecting the need in this community and the potential that FINTEPLA has to provide in seizure control for more patients with Dravet Syndrome. As we mentioned previously, strong interest from the Dravet community prior to the approval led to the roll-out of our expanded access program. This program enables us to establish and refine high-quality processes within our specialty pharmacy distribution activity. It also help us to ensure that our supply chain was well prepared, through the outstanding teamwork of the entire Zogenix team in the United States and Europe, finished FINTEPLA product was delivered to our distribution hub within just a few weeks following the approval. This is especially notable during this unprecedented global pandemic.
The final objective of our initial commercial launch is to continue educating healthcare providers and caregivers on the company efficacy and safety profile of FINTEPLA and to guide healthcare providers on the process of becoming certified prescribers of FINTEPLA. To this end, the fintepla.com product website, social media researches and finteplarems.com, all went live in early July. I am very happy to report that to-date, more than 230 US healthcare providers, who have many Dravet patients under their care, have successfully enrolled in the FINTEPLA launch program and are now certified to prescribe FINTEPLA.
FINTEPLA REMS certification is an important first step for physicians to begin subscribing FINTEPLA to new patients in the US as well as to transition patients who are currently taking FINTEPLA in our ongoing open-label extension studies and expanded access program to the commercial product. This high level of engagement for prescribers has exceeded our expectations, especially given the current COVID-19 environment and it reinforces the substantial interest in the product that we have heard from the communities for some time now.
We recently conducted an educational webinar for caregivers, in collaboration with the Dravet Syndrome Foundation, which was attended by more than 80 members of the Dravet community. This webinar provided medical information about FINTEPLA and the details of our Zogenix Central patient services, our comprehensive patients support hub, and specialty pharmacies.
As Steve mentioned, last week, on July 27th, our field-based sales and medical affairs team [Indecipherable] full launch of FINTEPLA. They are now educating physicians on the efficacy and safety profile of FINTEPLA. This will facilitate enrollment in the REMS program and they are also educating the city [Phonetic] office staff on the resources available through Zogenix Central.
Our key account managers have successfully contacted all healthcare providers, who are currently keeping patients in our open label extension studies and expanded access program within the first few weeks following the FDA approval. We are now continuing our promotional focus to the approximately 450 physicians who care about 80% of the treated Dravet Syndrome patients in the United States. The availability of the approved label has also allowed us to advance our FINTEPLA coverage discussions with private payers, from Medicaid administrators. Prior to the approval, we had the opportunity to meet with substantial number of payers. We educate them on the potential benefits of and key safety information for FINTEPLA, but discussions on coverage decisions could happen only after the FDA approval.
We are very happy to report that we have already started receiving several positive coverage determinations, recognizing that some coverage determinations can take time during this initial launch period, Zogenix Central will continue to assist on individual cases in an effort to expedite the coverage.
In summary, we are off to a very exciting start and we are very proud to bring this potentially transformative therapy to Dravet patients and their families in the US and this becomes an important option to reduce the number of devastating seizures these patients typically experience. I want to thank Dravet community for their ongoing support and thank the healthcare providers who have already become certified FINTEPLA prescribers. Reiterating what Steve said, I would also like to congratulate the entire Zogenix team who have worked tirelessly to launch FINTEPLA within just a few weeks of receiving the FDA approval and during the ongoing COVID-19 pandemic.
Now, I will turn the call back to Steve. Steve?
Stephen J. Farr -- President and Chief Executive Officer
Thank you, Ashish, for a great summary. In parallel to the US activities as Ashish has described, we continue to work with regulatory authorities to advance FINTEPLA and Dravet syndrome in other key regions. In Europe, the EMA's review of our marketing application is ongoing. Based on recent and encouraging progress, we anticipate CHMPs providing their opinion by the end of this year. In anticipation of a positive opinion, we are preparing for the potential launch of FINTEPLA in our first European country, Germany, in the first quarter of 2021. Additionally in Japan, we expect to have topline data from our Phase III pivotal trial in the fourth quarter of this year to support a planned JNDA submission in the first half of 2021.
Now I'd like to turn to our program for FINTEPLA in Lennox-Gastaut Syndrome or LGS. LGS is another rare and severe form of childhood-onset epilepsy. Unlike Dravet Syndrome, which is strongly correlated to variations in a specific gene, LGS can arise from multiple different causes, making seizures associated with LGS among the most difficult to effectively treat. A meeting with FDA has been scheduled for September, during which we will seek the agency's feedback on the non-clinical and clinical requirements to support our planned supplemental NDA or sNDA for FINTEPLA in LGS. As previously communicated, we have successfully completed a pivotal safety and efficacy Phase III trial, while are currently conducting special population Phase I pharmacokinetic trials and a two-year carcinogenicity study in rodents. Assuming data from these studies are required, we anticipate submitting an sNDA for FINTEPLA in LGS during the second quarter of 2021. As a reminder, the FDA has determined that based on an approval for FINTEPLA in Dravet syndrome, only one positive Phase III trial is required for LGS sNDA.
Now I'd like to switch to MT1621, our investigational therapy for the treatment of a devastating and frequently fatal mitochondrial DNA depletion disorder, called Thymidine Kinase 2 deficiency, or TK2d. MT1621 is an oral, fixed dose combination treatment of deoxycytidine and deoxythymidine that serves as substrate enhancement therapy to restore mitochondrial DNA and treat the progressive deficits in motor, respiratory and feeding functions that characterize this devastating disease. MT1621 has breakthrough therapy designation in the United States and PRIME designation in Europe, as well as orphan designation in both regions.
During the second quarter, we let twice for the FDA to discuss the development path for support of planned NDA submission for MT1621. We are very pleased with the outcome from these discussions, which supports our proposal that the survival benefit of treated patients as compared to an external historical control group is a reasonable basis for the NDA. As a reminder, we previously completed Study-101, a retrospective study of the combination of pyrimidine nucleosides in 38 patients with TK2d, which demonstrated a statistically significant, effective treatment on survival compared to an untreated control group of TK2 deficiency patients from the literature.
In addition to this analysis, the FDA requested that we obtain information on any additional treated patients who did not participate in a multi-sponsored study in order to have a complete survival analysis for the NDA. Note that in addition to our completed Study-101, we intend to include our ongoing prospective open label Study-102 as part of the NDA submission. Study-102 provides continued treatment with MT1621 for patients who participated in Study-101. Unfortunately, Study-102 has been impacted by COVID-19, as some patients, particularly those from outside the US and Europe are restricted from traveling to clinical sites to complete study assessments. However, patients have been able to continue uninterrupted treatment with MT1621 during this pandemic.
With respect to other feedback from the regulatory meetings, the FDA requested that we conduct a Phase I renal impairment pharmacokinetic study to provide dosing recommendations in the setting of impaired renal function.
Regarding non-clinical toxicology, we recently completed a six-month toxicology study in rats. The FDA also requested a toxicology study in dogs, but was willing to accept the study of a minimum of three months' duration versus the typical nine months, should we have concerns that the longer duration study would substantially delay the NDA submission. In addition, the FDA accepted all of CMC-related plans for the future submission. Assuming relaxation of certain restrictions related to COVID-19, we anticipate that all data for an NDA will be available by the end of 2021 in order to support the submission in the first half of 2022.
With that, let me hand over the call to Mike for his financial review. Mike?
Michael P. Smith -- Executive Vice President, Chief Financial Officer, Treasurer and Secretary
Thanks, Steve, and good afternoon, everyone. Today, we issued a press release announcing our business and financial results for the second quarter ended June 30, 2020, which I'll now run through.
We recognized $1 million in revenue during the second quarter of 2020. This is a result of our exclusive distribution collaboration with Nippon Shinyaku for FINTEPLA in Dravet Syndrome and LGS in Japan, who recognized $1.1 million in revenue for the corresponding period in 2019. R&D expenses for the first quarter were $34.4 million, an increase of approximately $7 million from $27.1 million in the corresponding period of 2019. This increase is attributable to a modest increase in spending in our Study-1601 LGS Phase III study, development expenses related to our late-stage clinical candidate, MT1621, and an increase in personnel and R&D and operational costs, all partially offset by a decrease in spending in our Dravet Syndrome program, as a number of studies in that area have come to closure.
SG&A expenses for the first quarter ended June 30, 2020 totaled $24.4 million, compared with $15.5 million for the second quarter of the prior year. The increase of approximately $9 million is primarily driven by the continued investment related to the launch of FINTEPLA for the treatment of Dravet Syndrome in the US, which began in the current quarter and for the preparation related to prospectively launching in Europe at the beginning of 2021.
One additional important item to highlight in the quarter, we received payments from the UK government of $19.7 million tax fund and tax credit related to FINTEPLA development activities in 2017 and '18 that qualify under the UK small and medium-sized enterprises R&D tax relief scheme. This $20 million claim contributed to our quarter-end cash balance.
Net loss for the second quarter ended June 30, 2020, was $53.3 million or $0.96 per share, and this compared to the net loss of $37.8 million or $0.89 per share in the second quarter ended June 30, 2019. We ended the second quarter with a strong balance sheet with cash, cash equivalents and marketable securities totaling $390 million. This significant cash position allowed us to invest in a robust and successful market of FINTEPLA in Dravet Syndrome in the US and Europe and simultaneously advance our key late-stage programs for FINTEPLA in LGS and MT1621 for TK2d.
With that, I'll now turn the call over to the operator to start our Q&A session. Operator, can you please open the line for questions?
Questions and Answers:
Operator
Thank you. [Operator Instructions] And we'll take our first question. It comes from Paul Matteis from Stifel.
Nathaniel Tower -- Stifel, Nicolaus & Company -- Analyst
Hey guys, this is Nate, on for Paul. Thanks for taking the question. Maybe the first one, real quick. What launch metrics are you guys planning on providing, like patient starts or something else?
Stephen J. Farr -- President and Chief Executive Officer
Ashish, you'd like to take that question? Ashish, you're on mute.
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
I'm sorry. Paul [Phonetic], thanks for the question. We'll be evaluating various metrics from our experience with the patients, clinicians as well as with the payers, that can provide reliable source of information and trend. As you know, we just launched last week and as we shared today, physician enrollment and completing certification on the REMS program is one of the key metrics, which is what we shared. And in the upcoming communication, we expect to provide more appropriate measures that will reflect the progress of the launch.
Nathaniel Tower -- Stifel, Nicolaus & Company -- Analyst
Got you. And then, I think, you've said about 250 to 300 patients in the US from the Dravet OLE? What's the average dose they're on, on a per kilogram basis? And how quickly do you think they're going to transition over to the commercial drug?
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
Yeah. I think you're referring to the open label extension and the early access program patients. Did I get that right?
Nathaniel Tower -- Stifel, Nicolaus & Company -- Analyst
Yeah, exactly.
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
Yes. So we are working on transitioning these patients. So first thing to keep in mind is that most of these patients have -- will not need to do a planned echo to start the therapy as the last echo they had done in the EAP and OLEs will be the part of their baseline. And I'm proud to say that we have been able to reach almost all the physicians in these programs, and they have now enrolled into their REMS. As we will be working on transitioning them as they have opted in the coverage, and then we are able to get them through the closure process that they need to do for the clinical trial. And the most important takeaway for here is that there is not going to be any interruption experienced by the patient during this transition. We do have a trial in this program and that will allow patients to continue receiving therapy as the coverage determination is being decided.
Nathaniel Tower -- Stifel, Nicolaus & Company -- Analyst
Got you. And what average dose are they on?
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
So the average dose that we talked last time was the average weight was 34.5, and the average dose was 0.52 milligram per kilogram.
Nathaniel Tower -- Stifel, Nicolaus & Company -- Analyst
Got it. Thanks very much.
Brian Ritchie -- Managing Director
Thanks for your questions.
Operator
Thank you. We can now move to our next question. This comes from Marc Goodman of SVB Leerink.
Roanna Ruiz -- SVB Leerink LLC -- Analyst
Hi, this is Roanna on the line for Marc. I have two. First, I don't know if I caught this during your prepared remarks, but for the MT1621 asset, could you clarify what the FDA was requiring for the clinical data portion? I know Modis has done some work previously and what extra work you're doing?
Stephen J. Farr -- President and Chief Executive Officer
Yeah, I'd be happy to answer that. And also, Joanne Quan, Chief Medical Officer of Modis is on the line and she can also add if there's anything that I'm missing here. So from the clinical perspective, we've completed Study-101, which will be a major basis of the NDA because that's where we've been able to establish the survival benefit. This is natural history control. And we also will be including information from Study-102, which is an extension study for all those patients who are now taking MT1621 for the treatments of their disease. In addition to that, as I said in prepared remarks, Joanne and her team will be obtaining information on other patients who have been treated with deoxynucleoside that were not part of the Modis studies or our studies. So we'll be obtaining information from those patients in order to complete the survival analysis set for the NDA. In addition to that, the FDA did ask us to conduct a study in renal impairment. So that's a Phase I study. So that will also be part of the clinical package for the NDA.
And Joanne, let me know if I've missed anything that you'd like to add.
Joanne Quan -- Chief Medical Officer, Modis Therapeutics
No. I think that's it. Does that address your question?
Roanna Ruiz -- SVB Leerink LLC -- Analyst
Yeah, that helped. And then one quick one, switching back to FINTEPLA. With the REMs enrollment and certification over-time, can you talk a bit about -- are these physicians mostly from, like academic centers or other sites? And how did it look going into July?
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
Yes. Thanks for the question, Roanna. I think the certifications we have so far, they are mixed. They are from the academic centers. They are from the community centers and these are, which -- as I said in our prepared remarks, are around 450 epileptologists and pediatric neurologists who treat about 80% of the Dravet patients. And I think we've been able to reach and get almost half of them certified through this process. I hope that answers to your question.
Roanna Ruiz -- SVB Leerink LLC -- Analyst
Yeah. And just, if you have any anecdotal comments about July?
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
At this time, no, because we've just launched last week, and we are watching the trend. And one thing I would say is, we are really excited with the response that we have got from the physicians, caregivers, and also some of the payers that we have had the conversation. So we are really feeling be very confident that we'll be able to bring this therapy to most of the patients as we go through the launch process.
Michael P. Smith -- Executive Vice President, Chief Financial Officer, Treasurer and Secretary
Sorry. Can I ask what your question on July is?
Roanna Ruiz -- SVB Leerink LLC -- Analyst
I was just wondering about the REMS cadence over-time, basically.
Michael P. Smith -- Executive Vice President, Chief Financial Officer, Treasurer and Secretary
Yeah. So the number we've given was kind of basically a reflection of what happens in July, [Indecipherable]. That's all.
Roanna Ruiz -- SVB Leerink LLC -- Analyst
Okay. Thank you.
Michael P. Smith -- Executive Vice President, Chief Financial Officer, Treasurer and Secretary
That's correct, yeah.
Stephen J. Farr -- President and Chief Executive Officer
Yeah. And the other way to say it, Roanna, is that, obviously, we're seeing a really great movement to our physicians into the REMS program, I think, which underscores, I think, the important Stage 3 of this drug in the treatment of Dravet Syndrome. So getting 230-plus physicians enrolled into the REMS in less than one week, I think, is a really good start for us.
Roanna Ruiz -- SVB Leerink LLC -- Analyst
Sounds good. Thanks.
Stephen J. Farr -- President and Chief Executive Officer
Thank you.
Operator
Thank you. And we'll move to our next question. This comes from Yatin Suneja of Guggenheim Partners.
Eddie Hickman -- Guggenheim Securities, LLC -- Analyst
Hi guys, this is Eddie on for Yatin. Congrats on the launch. I was just wondering if you could give us a sense of how long it will take to get the broader reimbursement for FINTEPLA? And is there certain states that can get it first? And how long it will take some of the slower states like Texas and Florida to get reimbursement? And then, what are your expectations for gross to net and Epidiolex is about 20%. Is that a reasonable assumption for FINTEPLA? Thanks.
Stephen J. Farr -- President and Chief Executive Officer
Ashish, go ahead and take those questions.
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
Yeah. So from the broader reimbursement perspective, as you know, the launch time, it does take time. And generally, what you have seen in some of the recent launches that it has taken up to six months to get the entire coverage. You have some states like Texas, which may take up to six months. Yeah, and there are some states, may happen in the next three months. And then we also have private payers, they have their own P&T reviews. Now we have got a schedule on them. We have scheduled the meetings and providing them the information. So I think over the next six months, we will see a huge increase in the coverage. So that is on the coverage side.
From the gross to net, I think, it will be very premature to provide any guidance at this point in time. We'll be evaluating how the launch goes, but more importantly, how we get the coverage. And based on that, in future, we may provide guidance on that.
Eddie Hickman -- Guggenheim Securities, LLC -- Analyst
Thanks. And then just one last one. For the Medicaid population, have you seen that number increase, given the pandemic and some of the increases that are seen in the country of unemployment? Do you expect that Medicaid ratio to change?
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
Yeah. So in general, if you look at the population, we can kind of look at the numbers, and say, yes, the Medicaid patient population should increase. In terms of our population and of what we are seeing, it's too early to say anything because it's been just eight working days since we have started promoting. But we expect that and we anticipate that will be similar to what we have seen in some of the other products, like the GW product, up to 55% and 60% of the patients are on Medicaid or some form of government paid insurance.
Eddie Hickman -- Guggenheim Securities, LLC -- Analyst
Thank you so much.
Stephen J. Farr -- President and Chief Executive Officer
Thank you.
Operator
Thank you. And we can now move to our next question. This comes from Difei Yang of Mizuho.
Alexander Lim -- Mizuho Americas LLC -- Analyst
Okay. Good afternoon, everyone. This is Alex on for Difei. I just had another question on the insurance coverage. Just in terms of the coverage determinations, you noted a few positive determinations already. Can you just comment if that's tracking sort of along your expectations or a little bit ahead? Any additional color around that would be helpful.
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
Yeah. Thanks for the question, Alex. At this point in time, it's tracking per our expectations and the work that we have done prior to the launch in educating the payers and the relationship that we have built is really coming to the bear at this point in time. So I would say it's tracking to the expectation.
Alexander Lim -- Mizuho Americas LLC -- Analyst
Okay, great. Thank you. And then just one more question on MT1621. Do you have any plans to disclose any additional follow-up data, I guess, at some point in the next few months or so?
Stephen J. Farr -- President and Chief Executive Officer
Joanne, do you want to take that one? We will be attending [Indecipherable]. So maybe you can say a few things about that.
Joanne Quan -- Chief Medical Officer, Modis Therapeutics
Sure. We have several abstracts that we'll be presenting [Indecipherable] in terms of the 1621 program. So I think that would be next point, at which we will be able to share that commentary.
Alexander Lim -- Mizuho Americas LLC -- Analyst
Great. Thank you.
Stephen J. Farr -- President and Chief Executive Officer
Thank you.
Operator
Thank you. And we will move to our next question. This comes from Serge Belanger of Needham & Company.
Tian Sun -- Needham & Company -- Analyst
Hi, good afternoon. This is Tian, on for Serge. I got two questions. So the first one, it's about REMS. So in terms of the Dravet patients themselves, how fast do you expect them to enroll into the REMS program versus doctors and physicians. And are you going to be disclosing these numbers in the coming quarters?
And then the second question is the Phase III Japanese trial. Could you remind us, is there any type of milestone payments that are tied to the readout of that trial in 4Q? And any other regulatory milestones with the NDA submission in Japan. Thank you.
Stephen J. Farr -- President and Chief Executive Officer
Ashish, take the first two questions, and maybe, Mike, you can take the question about Nippon Shinyaku after that?
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
Yeah. So in terms of Dravet patients enrolling into the REMS program, it depends on what type of patient they are. As I said earlier, these patients are from early access program on the clinical trial. Their enrollment is going to be fairly smooth because they do not have to go through the echo. And what we believe is that based on when they are able to visit their physician, they should be to enroll pretty seamlessly and quickly. One thing is, we have the REMS documents and the enrollment documents, are available on the website, they're available in their mobiles. Your can download from the mobile devices. You can electronically sign them, so we have made it much easier.
For the naive patients, it takes almost the same time, I think the only step there is going to be the naive patients will have to go through an echo process. So they will have to do an echo. And that takes -- as we said earlier, it will take anywhere between two to four weeks, depending on your ability to find the appointment, going to the institute and depending on that particular institute where the echo is available or any other place. But so far, what we have seen in the last, I would say, a week and half, those enrollments are going as smoothly as we had expected. Mike?
Michael P. Smith -- Executive Vice President, Chief Financial Officer, Treasurer and Secretary
Yeah. Through our collaboration with Nippon Shinyaku, there are a couple of payments that relate to the JNDA submission for Dravet as well as for LGS and Dravet, much more in the near term -- a lot more in near term than the LGS study on the near-term horizon. The amounts that are tied to our submission, approved and then subsequently a price listing, which comes in Japan right after an approval. So it's in the neighborhood of the mid-teens, in combination of both those, in terms of milestone payments. And then, LGS, which is ongoing as well, and will come at, come in a little bit at the time after Dravet, have those same types of the milestone payments and those milestone payments are in the high-20 [Phonetic] combined.
Tian Sun -- Needham & Company -- Analyst
Got it. Thank you.
Stephen J. Farr -- President and Chief Executive Officer
Yeah. Thank you for your questions.
Operator
Thank you. And we'll then move to our next question from Tim Lugo of William Blair.
John Boyle -- William Blair & Company L.L.C. -- Analyst
Hi, this is John on for Tim. Thanks for the questions. Just two from us. So first, I'm just wondering how you guys are thinking about prioritizing getting additional sites REMS certified. Are you more focused on specific regions given the local state of the pandemic or are you more focused on other factors like size and potential number of patients?
And second, I'm not sure if I missed it in the prepared remarks. Do you have any updates on the basket study of FINTEPLA? And if you haven't updated us, is there anything you're looking for to see before you start restarting it? Thanks.
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
Steve, I will take the first one and give it to you. So in terms of -- John, in terms of prioritization, we're prioritizing on these key epileptologists, as I said in the remarks. There are around 450 epileptologists and pediatric neurologists who treat approximately 80% of the patients. So we'll be reaching to them first and this is where our entire field team's focus is going to be in the initial phase of the launch. And once that is done, then we're going to go to the next one. There is no, what I call it, is a limitation from the geography or because of the COVID situation, primarily, because we've been able to connect with these offices, if not in person, through telephone, through the Zoom calls. And we have made the entire enrollment process available online. And most of these solutions have enrolled online and very easily from different devices.
So hopefully that answers your question, but we'll go first with [Indecipherable] epileptologists and then to the next set. Steve?
Stephen J. Farr -- President and Chief Executive Officer
Yeah. Thanks. John, with respect to the basket study, as you know, we've put that on pause because of the COVID-19 situation and really a realization, it was difficult and probably inappropriate to initiate a new clinical study at the time. So we have clearly kept our eye on what's going on since we had approval in of FINTEPLA today. We have started to see if there's opportunities to look to get this study back up and running. I don't have any time lines on that right now, but we are actively evaluating well enough if there's an opportunity to at least get some of these cohorts of patients into the study, just to sort of recall for everyone into the study, where we're bringing in several different epileptic encephalopathies or severe epilepsies under one protocol, and they will be divided into various cohorts. And we're looking to see if we can get some of these cohorts up and running. So we'll talk certainly more about that once we've got some more information.
John Boyle -- William Blair & Company L.L.C. -- Analyst
All right. Great. And congrats on the launch.
Stephen J. Farr -- President and Chief Executive Officer
Thank you.
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
Thank you very much.
Operator
[Operator Instructions] And we now move to our next question. This comes from Michael Higgins of Ladenburg Thalmann.
Michael John Higgins -- Ladenburg Thalmann & Co. -- Analyst
Thanks Operator. I have two questions. First of all, congrats on the launch of your [Indecipherable] benefited by the online launch characteristics. You've also mentioned 230 healthcare providers being signed up so far. If you could just give us a little breakout of that. I assume you have included physicians and nurses. So how many sites of the 230 is spread across and given the target goals for the back half of 2020?
Stephen J. Farr -- President and Chief Executive Officer
Thank you, Michael. Ashish, do you have that breakdown for Michael?
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
At this time I don't have the breakdown, but what I can tell you confidently that more than 95% of these will be physicians because we've been able to reach all of them. What we do know is that there are few physician assistants, they are nurse practitioners, have signed up because they were part of the early access program on the clinical trial sites. But we can come back to you and give you that breakdown in terms of how many physicians. And in terms of the target goal, as I said earlier, our goal is to get all these 450 key epileptologists signed up as early as possible and then move on to the next target, which is the epileptologists who may be treating maybe one or two Dravet patients, but we want to make sure that we reached them and enrolled them for the REMS, so that they can offer FINTEPLA to their patients.
Michael John Higgins -- Ladenburg Thalmann & Co. -- Analyst
Okay. That's helpful. Thank you. And just maybe sort of help with this. You mentioned on prior calls as well as this one that no patient will miss a dose. I assume that there is some sort of a protocol for handling those patients during a transition period. How do you look at that? Is that something that every month, they sent a month's supply to do that for several months at a time? How is that normally handled?
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
Let me playback your question so that I understood it. So the question is regarding the transition, how do we handle the dose? And how much do we supply as we send during this transition period? Did I get that right?
Michael John Higgins -- Ladenburg Thalmann & Co. -- Analyst
Yeah.
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
So at this point in time, based on -- and we follow the same guideline as what we get from the insurance companies that during the transition, we will be providing 30 days at a time, and we will continue to follow-up based on how the coverage determination is made. And then based on that, we will continue to either provide the transition products or switch to a commercial covered product.
Michael John Higgins -- Ladenburg Thalmann & Co. -- Analyst
What is the typical transition period?
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
At this time, it's really early to say because we just started this last week. So we will have better metrics, hopefully in the future. But at this point in time, it will be too premature to say the numbers here.
Michael John Higgins -- Ladenburg Thalmann & Co. -- Analyst
Okay. I appreciate the feedback. Thanks guys.
Stephen J. Farr -- President and Chief Executive Officer
Thank you.
Operator
Thank you. And at this time, we have no further questions. So I'll hand the call back to Dr. Stephen Farr.
Stephen J. Farr -- President and Chief Executive Officer
Thank you, operator, and thank you all for joining us on our call today. We are very, very pleased, extremely pleased to share our progress, becoming a commercial-stage, rare disease company with a strong pipeline of very promising therapeutic candidates. Those candidates are really showing tremendous efficacy in some devastating diseases. I look forward to providing with further updates on our launch programs and clinical activity. So thank you all, again, for joining us on our call today, and enjoy the rest of your day.
Operator
[Operator Closing Remarks]
Duration: 41 minutes
Call participants:
Brian Ritchie -- Managing Director
Stephen J. Farr -- President and Chief Executive Officer
Ashish Sagrolikar -- Executive Vice President and Chief Commercial Officer
Michael P. Smith -- Executive Vice President, Chief Financial Officer, Treasurer and Secretary
Joanne Quan -- Chief Medical Officer, Modis Therapeutics
Nathaniel Tower -- Stifel, Nicolaus & Company -- Analyst
Roanna Ruiz -- SVB Leerink LLC -- Analyst
Eddie Hickman -- Guggenheim Securities, LLC -- Analyst
Alexander Lim -- Mizuho Americas LLC -- Analyst
Tian Sun -- Needham & Company -- Analyst
John Boyle -- William Blair & Company L.L.C. -- Analyst
Michael John Higgins -- Ladenburg Thalmann & Co. -- Analyst
