ZGNX (2020 - Q2)

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 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; Chief Commercial Officer, Ashish Sagrolikar; and Chief Financial Officer, Michael Smith; as well as Dr. Joanne Quan, Chief Medical Officer of Modis Therapeutics and Zogenix company. This afternoon, Zogenix issued a news release providing a business update and announcing financial results for the second quarter ended June 30, 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 included 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 5, 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.

Thank you, Brian, and good afternoon to everyone. We ended the previous quarter with a 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 to achieve this tremendous milestone. This approval has enabled us to enter the third quarter as a fully integrated commercial biopharmaceutical company. The official U.S. launch of FINTEPLA occurred last week on July 27, and we're excited that commercial product has been shipped in first patients 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.

Thank you, Steve. I'm excited to share our initial progress on the launch of FINTEPLA in the U.S., which is going extremely well following the FDA approval on June 25. Since then, we've continued 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 rollout of our expanded access program. This program enabled us to establish and refine high quality processes within our specialty pharmacy distribution activities. It will 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 few weeks following the approval. This is especially notable during this unprecedented global pandemic. The primary objective of our initial commercial launch used to continue educating healthcare providers and caregivers on the compelling efficacy and safety profile of FINTEPLA and to guide healthcare providers on the process of becoming certified prescribers of FINTEPLA. With this end, the fintepla.com product website, social media researches and FinteplaREMS.com, all went live in early July. I’m happy to report that to date more than 230 U.S. healthcare providers who have named Dravet patients under their care have successfully enrolled in the FINTEPLA REMS program, and are now certified to prescribe FINTEPLA. FINTEPLA REMS certification is an important first step for physicians to being prescribing FINTEPLA to new patients in the U.S., 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 by prescribers have 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 community for some time now. We recently conducted and education webinar for caregivers in collaboration with the Dravet Syndrome Foundation, which was attended by about more than 30 members of the Dravet community. This webinar provided medical information about FINTEPLA, and the details about Zogenix-centered patients for these sites are comprehensive patient support hub and specialty pharmacy. As Steve mentioned, last week on July 27, our field based sales and medical affairs team with still 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 CP office staff on the resources available in the Zogenix Central. Our key account managers have successfully contacted all healthcare providers who are currently keeping patients in our open-label extension study and expanded access program within the first few weeks following the FDA approval. We are now continuing our promotional focus to be 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 discussion with private payers and Medicaid administrators. Prior to the approval, we had the opportunity to meet with substantial number of payers to educate them of the potential benefits to us and key safety information for FINTEPLA that discussions and coverage decisions could offer only after the FDA approval. We are 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 our individual cases in an effort to expedite the coverage. In summary, we are off to a very exciting start, we are very proud to bring this potentially transformative therapy to Dravet patients and their families in the U.S. and this becomes an important option to reduce a 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 teams who have worked tirelessly to launch FINTEPLA within just few weeks of receiving the FDA approval during ongoing COVID-19 pandemic. Now I’ll turn the call back to Steve. Steve?

Thank you, Ashish for a great summary. In parallel to the U.S. activities as Ashish described, we continue to work with regulators for these advanced FINTEPLA in 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 CHMP providing that opinion by the end of this year. In anticipation of public opinion, we’re preparing for potential launch of FINTEPLA in our first European country, Germany, in the first quarter of 2021. Additionally, in Japan, we expect to have top line data from our Phase 3 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 would seek the agency's feedback on the nonclinical 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 3 trial and we’re currently conducting patient population Phase 1 pharmacokinetic trials on the two-year convulsive study enrollments. Assuming data from these studies are required, we anticipate submitting a sNDA for FINTEPLA in LGS during the second quarter of 2021. As a reminder, the sNDA has determined that based on an approval from FINTEPLA in Dravet syndrome, only one positive Phase 3 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 United States and PRIME designation in Europe, as well as orphan designation in both regions. During the second quarter, we’ll twice for the FDA to discuss the development path to support the 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've previously completed Study 101, a retrospective study of the combination of pyrimidine nucleosides in 38 patients with TK2d, which demonstrated a statistically significant effect of treatment on survival compared to an entry to 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 no responsive 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 treatments with MT1621 for patients who participated in Study 101. Unfortunately, Study 102 has been impacted by COVID-19. At some patients, particularly those from outside in U.S. 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 from hepatic studies to provide dosing recommendations in the setting of impaired renal function. Regarding non-clinical toxicology, we recently completed a six months toxicology study in rats. The FDA also requested a toxicology study in dogs, but was willing to accept a 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 our 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?

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 the result of our exclusive distribution collaboration with Nippon Shinyaku for FINTEPLA in Dravet syndrome in LGS in Japan. We recognized $1.1 million in revenue for the correspondence series 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 [indiscernible] operational costs all partially offset by decreasing 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, primarily driven by the continued investment related to the launch of FINTEPLA for the treatment of Dravet syndrome in the U.S., which began in the current quarter and for the preparations related to prospectively launching in Europe at the beginning of 2021. One additional important item to highlight in the quarter, we received payment from the UK government of $19.7 million R&D tax credit related to our FINTEPLA development activity in 2017 and 2018 that qualify under the UK small and medium size enterprises R&D tax relief scheme. This $20 million payment contributed to our quarter end cash balance. Net loss for the second quarter ended June 30, 2020 was $53.3 or $0.96 per share. And this compares 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 that’s prevalent in marketable securities total in $399 with significant cash position allows us to invest in a robust and successful launch of FINTEPLA in Dravet syndrome in the U.S. and Europe, and simultaneously in advanced our key late stage programs for FINTEPLA and LDS, and MT1621 or 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?

Thank you. [Operator Instructions] And we’ll take our first question, it comes from Paul Matteis from Stifel.

Hey guys, this is Nate on for Paul. Thanks for taking the question. Maybe first one real quick. What launch metrics are you guys planning on providing patient starts or something else?

Ashish, you like to take that question? Ashish you are on mute.

I’m sorry. Paul, thanks for the question. We will be evaluating various metrics from our experience with the patients, clinicians as well as with the payers that can provide a reliable source of information and trends that we just launched last week. And as we said today, physician enrollment and completing certification in 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.

Got you. And then I think you said about 250 to 300 of the patients in the U.S. from the Dravet or LGS. 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 commercial drug?

Yes, I think you’re referring to the open-label extension and the early access program patients. Did I get that right?

Yes, exactly.

Yes. So we are working on transitioning these patients. So first thing to keep in mind is that most of these patients will not need to be in plan echo to start the therapy, as the last echo they have 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 enrolling together. So we will be working on transition then as they – as we popped into coverage. And then we are able to get them through the closure process that they need to do for the clinical trial. The most important takeaway for here is that there is not a going to be any interruption, as far the patients getting strong result. We do have a trial in this program and that will allow patients to continue receiving therapy, hence the coverage determination is being decided.

Got you. And what average dose they are?

So the average dose that we talked last time was the average date was 34.5 and the average dose was 0.5 milligram per kilogram.

Got it. Thanks very much.

Thanks for your questions.

Thank you. And we can now move to our next question. This comes from Marc Goodman of SVB Leerink.

Hi. This is Roanna on the line for Marc. Thanks for taking the question. I have two. First, I don't like process 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 were doing?

Yes, I'd be happy to answer that. And also Joanne Quan, Chief Medical Officer of Modis 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 not for high speed control. And we also – we'll be including information from Study 102, which is an extension study to all those patients who are now taking MT1621 for the treatments on their disease. In addition to that, as I said in prepared remarks as Joanne and her team will be obtaining information on other patients who have been treated with the [indiscernible] were not part of our – of the Modis studies or our studies. So we'll be obtaining information from those patients in order to complete the survival analysis for the FDA. In addition to that, and the FDA did ask us to conduct a study in renal impairment. So that's a phase one 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.

No, I think that's good, because that address your question.

Yes. That helps. And then one quick one switching back to FINTEPLA would be REMS enrollment and certification over time. Could you talk a bit about, are these physicians mostly from like academic centers or other sites and how did it look going into July?

Yes. Thanks for the questions, Roanna. I think the certifications we have so far, they are mixed. They are from the academy centers. They are from the community centers. And [indiscernible] around 450 and periodic who treat about 80% of the Dravet patients and I think we've been able to reach and get almost half of them certified process. Could that answer your question?

Yes. And if you have any anecdotal comments about July?

At this time, no because we just launched last two and really watching the trend. And one thing I would say is, we’ll be excited with the response that we have got from the physicians, caregivers and also a lot of payers that we are on the conversation. So, we are really feeling very confident that we we’ll be able to bring this therapy to the most of the patients as we go through the launch process.

Sorry, can I ask what your question on July is?

I was just wondering about when cadence overtime basically.

Got you. So the number we’ve given you kind of go through that reflects on what happens in July. [indiscernible] That’s all.

Okay, thank you.

I want to see that. that’s clear.

Yes. The other way to say, obviously, we’ve seen a – really a great movement of physicians into the REMS program. I think it should underscore, I think the importance of this drug and the treatment of Dravet syndrome. So, getting 230 plus physicians involved into the REMS, I think it’s a really good stuff for us.

Sounds good. Thanks.

Thank you.

Thank you. And we’ll move to our next question. This comes from Yatin Suneja of Guggenheim Partners.

Hey, guys. this is Eddie for Yatin. Congrats on the launch. I was just wondering if you could give us a sense of how long will it take to get the broader membership for FINTEPLA and is there certain things that can get at first and how long it will take some of the slower speeds like Texas and Florida to get reimbursement. And then what are your expectations for gross to net and the balance is about 20%, is that a reasonable assumption for FINTEPLA? Thanks.

Ashish, go ahead and take those questions.

Yes. So, from the part of reimbursement perspective, as you know, the launch time, it does take time and it’s generally what you have seen in some of the recent launches that it got taken up to six months to get the emphatic coverage. You have some states like Texas, which may take up to six months. Yes. And then some states may happen in the next two months. And then we also have private payers. they have their own P&T reviews, and now, we have kind scheduled on them and we have scheduled few things 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 this, providing the guidance at this point in time. We will be evaluating how the launch goes, but more importantly how we get the coverage and based on that in future, we will provide guidance on that.

Thanks. Just one last one for the Medicaid population, have you seen that number increased given the pandemic and some of the increases that are seen in the country of unemployment, do you expect that Medicaid ratio to change?

Yes. So, in general, if you look at the population, we can kind of look up the numbers and say, yes, that Medicaid patient population should increase. In terms of our population and not what we are seeing, it’s too early to say anything, because it’s been just – eight working days since we have started from that. But we expect that and we anticipate that will be similar to what have seen in some of the other products like GWS product, that up to 55% or 60% of the patients are on Medicaid or some form of government paid insurance.

Thank you so much.

Thank you.

Thank you.

Thank you. We can move to our next question, this comes from Difei Yang of Mizuho.

Hey, 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 a long expectations are a little bit ahead, any additional color on that would be helpful.

Thanks for the question, Alex. At this point in time, it’s tracking for our expectation, yes, and the work that we have done prior to the launch and educating the payers and the relationship that we have – is really coming to the bear at this point in time. So, I would say it’s tracking to the expectation.

Okay, great. Thank you. And then just one more question 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?

Joanne, do you want to take that one or we are – we will be attending [indiscernible]. So maybe you can say few things for that.

We have several aspects that we’ve been presenting there in terms of the 1621 program. So, I think that would be the next point I would share even to share that publicly.

Great. Thank you.

Thank you. We’ll now move to our next question, this comes from Serge Belanger of Needham and company.

Hi, good afternoon. This is from [indiscernible] 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 consider doctors and physicians? And are you going to be disclosing these numbers in the quarters – in the coming quarters? And then the second question is the Phase 3 Japanese trial. Could you remind me is there any type of milestone payments that are tied to read out of that trial in 4Q and any other regulatory milestones with the any information that you have? Thank you.

Ashish take the first two questions, maybe Mark, you can take the question about the [indiscernible]?

So in terms of Dravet patients enrolling in to REMS Program. It depends on what type of patient they are. As I said, earlier these patients have some early access program on the clinical trials, then it 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 the physician, they should be able to enroll quickly. One thing is we have the events, got a document and the enrollment documents are available on the website, they are available in their mobile, you can download from the mobile directly, you can electronically find them. So we have made it much easier. For the naïve patients, it takes almost the same time. I think the only step there is going to be the naïve patients have to go through echo process. So they're going have to do an echo. And that takes as we said earlier it will take between two to four weeks, depending on your ability to find the assignment, going to the institute and depending on that particular institute where the echo is available for. But so far what we have seen in the last, I would say a week and half, big enrollments are going absolutely as we had expected. Mike?

Yes. So through our collaboration with the Nippon Shinyaku, there are a couple of payments that relate to J-NDA submission for Dravet as well as for LGS NDA much more in near term, not more in near term than the [indiscernible] on the near term horizon. The amounts are tied to our submission and approval and then subsequently a price listing, which comes in Japan right after an approval. So it's in the neighborhood of the mid-teen in combination with both those in terms of amounts and payments. And then LGS, which is ongoing as well and we'll come out – will come in a little bit of time after delay have those same types of milestones payments and those milestone payments are in the high 20 marks combined.

Got it. Thank you.

Yes, thank you for your questions.

Thank you. And we’ll now move to our next question from Tim Lugo of William Blair.

Hi, this is Sean on for Tim. Thanks for the question. 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? 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 efficacy study of FINTEPLA? And if you haven’t updated us, is there anything you are looking for to see before you start restarting it? Thanks.

Stephen I’ll take the first one and give it to you. So in terms of – John [ph] in terms of prioritization, which we are prioritizing from these key epileptologists where they are certifying the remarks, there are around 450 epileptologists and pediatric neurologists who cheat approximately 80% of the patients. So we will 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 are going to go to the next one. But if you note, see what I call it as a limitation from the geography or because of the COVID situation, primarily because we have 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, easily from different devices. So hopefully that answers your question that we will go first with these key epileptologists and then to the next set. Steve?

Yes, thanks. John [ph] with respect to the basket study, as you know, we put done on hold because of the COVID-19 situation and really our realization it was difficult and probably inappropriate to initiate a new clinical study at the time. So we have clearly kept an eye on what's going on since we had an approval in FINTEPLA on Dravet. We have started to see if there's opportunities to look through get this study back up and running. But I don't have any timelines in that right now, but we are actively evaluating whether or not there is an opportunity to at least get some of these cohorts of patients into the study just to sort of recall for everyone. And we see this study as 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 the assumed cohorts up and running. So we will talk certainly more about that, once we got some more information.

Great. Thanks. And congrats on the launch.

Thank you.

Thank you very much.

[Operator Instructions] Now we move to our next question, this comes from Michael Higgins of Ladenburg Thalmann.

Thanks, operator. I have two questions. First of all, congrats on the launch of your SUMAVEL, it seems to benefitted from the outline amongst characteristics. You've also mentioned two healthcare providers being signed up so far. Can you just give us a little break out of that? I assume these include physicians and nurses, so how many site opportunities spread across? And do you have any target goals for the back half of 2020? Thanks.

Thank you, Michael. As you have that breakdown, Michael.

At this time, like, I don’t have the breakdown, but what I can tell you confidentially is that maybe the 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, nurse practitioners have signed because they were part of the actual store that on the clinical trial sites, that we can come back to you and give you that breakdown in terms of how many physicians. In terms of the target goal, as I said earlier, our goal is to get all these 453 epileptologists signed up has been faster than, and then move on to the next target, which is the epileptologists we may be keeping maybe one or two other Dravet patients, that we want to make sure that we reached them and enrolled them to their end. So that they can offer from definitely their patients.

Okay. That's helpful. Thank you. And just give us a little help with this. You’ve mentioned on prior calls, as well as this one that no patient were missed the bills. I assume that there – if there's some sort of a protocol for handling those patients during a transition period. And how do you work that, is that something that every month they send them off supplies to do that for several months at a time? How is that normally handled?

Let me play back your question, so that I understood it. So the question is regarding the transition, how did we handle the bills and how much do we supply from during this transition period? Did I get that right?

Yes.

Yes. So a bit quarantine based on and we follow the guidelines as what you get from insurance companies that during the transition we will be providing 30-day that are trial, 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 product or switch to a commercially lead product.

What is the typical transition period?

At this time it's really early to say because we just started this last week. So we will have better metrics hopefully in future, but at this point in time, it could be pretty premature to say the numbers?

Okay, appreciate the feedback. Thanks, guys.

Thank you.

Thank you. And at this time we have no further questions, so I'll hand the call back to Dr. Stephen Farr.

Thank you, operator, and thank you all for joining us on our call today. We're very, very pleased, extremely pleased to share our progress, becoming a commercial stage, ready to use company, with a strong pipeline of very promising therapeutics candidate, and those kinds of eights already showing tremendous efficacy and in some devastating diseases. Look forward to providing with few updates on our launch progress in clinical activity. So thank you all again for joining us on a call today and enjoying the rest of your day.

This concludes today’s call. Thank you all for your participation. You may now disconnect.