Zogenix, Inc. (ZGNX) 2021 Q1 法說會逐字稿

Greetings, and welcome to the Zogenix, Inc., First Quarter 2021 Financial Results Conference Call. (Operator Instructions) As a reminder, this conference is being recorded today, Thursday, May 6, 2021.

I'd now like to turn the conference over to Brian Ritchie of LifeSci Advisors. Please go ahead.

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. This afternoon, Zogenix issued a news release providing a business update and announcing financial results for the first quarter ended March 31, 2021.

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, May 6, 2021. 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, and good afternoon to everyone. I'm very pleased to be here with you today to provide updates on what has been another exciting and productive quarter for Zogenix. Despite the operational challenges brought on by the ongoing pandemic, our commercial launches of FINTEPLA for Dravet syndrome in the United States and Europe continue to progress well.

As Ashish will describe shortly, we are very encouraged by the steady growth in adoption by both existing and new prescribing physicians and patients, by the continuing positive dialogue with commercial and government payers. With more physicians gaining experience with FINTEPLA and more patients reaching the effective dose, we see a marked increase in FINTEPLA prescriber base and a beneficial impact on dosing trends.

We are now beginning to see an increase in the ability of our field-based teams to travel and meet with physicians and other health care professionals. As a result, we are looking forward to the positive impact this will have on our commercial activities and other aspects of our business.

I'll now turn the call over to Ashish for further details on how our launches are progressing in the U.S. and in Europe. Ashish, over to you.

Thank you, Steve. I'm very pleased to update you on our team's continued strong execution of the FINTEPLA launch in the U.S. and to share with you details of the early momentum we are gaining in Europe.

In the first quarter of 2021, we achieved $12.3 million in FINTEPLA net product sales. FINTEPLA net sales in the U.S. were $11.3 million and $1 million in Germany. This strong performance reflects the significant desire within the Dravet community to initiate and continue treatment with FINTEPLA.

We have been fairly pleased with our ability to sustain this moment despite significant COVID-related headwinds. And in the U.S., weather-related disruptions that impacted most of the country in the beginning of the year. We continue to expect higher adoption and long-term use of FINTEPLA to increase as more physicians gain positive experience treating patients. And as Steve noted, the impacts of COVID begin to diminish.

In the U.S., growth in the number of health care professionals enrolling into the REMS program, the initial step and indicator of physicians' interest in prescribing FINTEPLA, remains robust. By the end of Q1, approximately 570 HCPs were certified in our REMS program with a majority already prescribing FINTEPLA. More than 90% of these prescribers are new, that is they did not participate in our clinical trial or expanded access program, reflecting the broadening interest in prescribing FINTEPLA.

During the first quarter, 151 new patients were prescribed FINTEPLA, which brought the total number of REMS referred and prescribed patients in the U.S. to just over 700. This is a 27% increase since the end of 2020. Importantly, we saw a consistently increasing rate of new patient referrals month-to-month from January through March. We are extremely pleased by this trend and expect to see continued growth throughout the year.

By the quarter end March 31, the number of patients receiving reimbursed FINTEPLA in the U.S. grew by 35% to more than 560 patients. More than 90% of this growth in Q1 was driven by patients who were new to FINTEPLA and the rest consisted of the final participants transitioning to commercial therapy from our open-label studies and expanded access program.

We continue to be extremely pleased with the payer coverage and access for FINTEPLA. By the end of Q1, payers covering more than 75% of U.S. lives had published a formal policy to cover FINTEPLA as per label and on parity with other AEDs, with the rest of plans covering it through prior authorization and medical necessity process due to the rare prevalence of Dravet syndrome in their covered population.

Additionally, we successfully completed the coverage reverification process for all patients during the month of January, reinforcing payers' belief in FINTEPLA's therapeutic value. Since launch, the majority of FINTEPLA prescriptions in the U.S. have been written for patients diagnosed with Dravet syndrome, but we are also seeing some patients prescribed and enrolled in the REMS program for other forms of severe rare epilepsy. By the end of Q1, the percentage of prescriptions written for seizure disorders other than Dravet syndrome was in the mid-teens.

We also see increased physician confidence in titrating patients to the effective dose relative to patients' weight, seizure reduction and tolerance. Current prescribing patterns indicate that approximately 55% of patients reach their effective dose by the fourth month of the treatment with the remainder reaching by six. The average daily dose of FINTEPLA following titration is similar to what we saw in the expanded access program, namely approximately 0.5 milligram per kilogram per day.

Although it is still very early in our launch, our retention rate continues to be very high at 93%, consistent with our experience in the expanded access program and clinical studies. As vaccination rates in the U.S. increase and restrictions ease, more of our customer-facing teams have been able to schedule in-person interactions with HCPs and their staff. We believe this positive trend will continue into the second half of the year, making it an easier environment for us to interact with physicians, patients and families who are now considering treatment with FINTEPLA to improve seizure control.

Transitioning to Europe. Our first European launch in Germany is progressing very well. In the first few weeks after the mid-February launch, more than 50 clinicians had enrolled in the controlled access program to become eligible to initiate FINTEPLA therapy for their patients. In Germany, approximately 100 Dravet patients are participating in our open-label extension studies and expanded access program. These patients are now in process of transitioning to commercial therapy, a progression we expect to be completed by the end of June.

In France, patients are now being prescribed FINTEPLA under the temporary use authorization, or ATU, as we discussed earlier in this year. Access to FINTEPLA in France will be under this ATU program until reimbursement negotiations are finalized. Pricing and reimbursement negotiations across major European markets such as United Kingdom, France and Italy are progressing well.

In April, we launched the Zogenix access program to further expand the availability of FINTEPLA to physicians in the other parts of the world where local regulations allow. This also includes some European countries where reimbursement has not yet been established. We look forward to supporting more HCPs and patients in need through this new program.

Further reflecting a strong global interest in FINTEPLA in Q1, we entered into an agreement with (inaudible) Pharma to make FINTEPLA available for patients in Israel. We are now working with our partner to prepare and file the appropriate regulatory and reimbursement documents for approval and covered use in Israel.

To conclude, we are very pleased with -- that more patients are now benefiting from treatment with FINTEPLA due to our strong growth in the United States, progress in Europe and addition of new programs and partnerships in other countries. We anticipate continued momentum, and we hope the worst impacts of pandemic pass, and we receive pricing and reimbursement approvals in additional European countries.

Now I will turn it back to Steve. Steve?

Thank you, Ashish, for the great progress. Next, I'd like to update you on our pipeline, including FINTEPLA for our second and larger indication opportunity, Lennox-Gastaut syndrome, or LGS, as well as FINTEPLA for Dravet and LGS in Japan.

Our community and patient advocacy discussions reinforce that LGS remains one of the most challenging rare epilepsies to manage, and many LGS patients still desperately need new treatments for this severe disease. Therefore, we're excited to be on track for a planned third quarter 2021 submission of a supplemental NDA in the United States for FINTEPLA in LGS, followed by MAA filing in Europe in the fourth quarter. Both are high priorities and significant milestones for us in 2021. As part of our preparations, we intend to meet with the FDA during this quarter for a pre-sNDA meeting to confirm discussions agreements from our earlier and Phase III meeting, and to align on the final electronic submission structure.

In parallel, we were excited to report new clinical data for FINTEPLA in LGS in a podium presentation at the recent AAN 2021 meeting. These results from our pivotal clinical trial in LGS show the positive impact of FINTEPLA on patients' abilities to self-regulate behavior, emotions and cognitions. These nonseizure findings complement earlier Phase III data analysis demonstrating that FINTEPLA has significantly reduced drop seizure frequency and notably, the frequency of generalized tonic-clonic seizures that are a primary risk factor towards sudden unexpected death in epilepsy or SUDEP. We believe these data, combined with a novel mechanism of action relative to other approved therapies, positions FINTEPLA as a potentially important new treatment option for LGS patients.

The clinicians we have engaged in advisory panels reinforce that seizure control is the primary treatment goal for LGS and that any patients whose seizures are not well controlled could be candidates for FINTEPLA treatment. While clinicians indicate they would likely try FINTEPLA for all of their refractory LGS patients, they also stated that they may place this higher in the treatment algorithm for patients who experience a high number of generalized tonic-clonic seizures and who may, in other ways, be at risk of SUDEP.

Now turning to FINTEPLA in Japan. We remain on track for our planned JNDA submission for Dravet syndrome later this year. Separately, the last of 33 patients have been randomized into our LGS study in Japan, which the PMDA requested to enable the comparison responses in Japanese patients to the multinational data from Study 1601, our broader Phase III trial.

In addition to Dravet and LGS, we are also making great progress around the planning of our Phase III trial of FINTEPLA in CDKL5 deficiency disorder or CDD. As a reminder, Dr. Orrin Devinsky at the NYU Langone Medical Center, last year shared compelling data from his investigator initiated study of several patients with CDD. We plan to discuss the final protocol with the FDA during this quarter and expect to begin enrollment of CDD patients into the study in the second half of the year.

As you can see, we have significant growth plans for FINTEPLA. To complement these objectives, our intellectual property position for FINTEPLA was further strengthened last quarter by the addition of 2 further U.S. patents in the Orange Book. This brings the total listed patents for FINTEPLA to 10, with patent expiries ranging from 2033 to 2039.

Now I'd like to discuss MT1621, our late-stage investigational therapy for thymidine kinase 2 deficiency or TK2d. I'm excited to report our continued progress as we bring this therapy forward to a patient population with no approved 3 months. Leveraging our data set, demonstrating benefit in both morbidity and mortality in TK2d, we will pursue an indication encompassing all patients in our FDA filing.

Based on our discussions with the EMA in Europe, we will pursue an initial indication of patients with early onset disease with a goal of making this drug available as soon as possible. The late onset group represents a minority of the population, an estimated 20% of all TK2d patients, which has only recently been recognized and is less studied. Young onset patients represent the largest group of patients and those with a clear high unmet need.

Untreated disease in infant and childhood-onset patients often results in loss of developmental milestones, and may progress rapidly to respiratory failure and death. All our studies required for the record submissions are advancing as planned, and we remain on track to submit an NDA for MT1621 in the first half of 2022 and an MAA for European approval shortly thereafter.

In parallel to our development work, we are pursuing a range of activities to identify patients and better characterize TK2d. As with many mitochondrial diseases, TK2d is significantly underdiagnosed. In the setting of clinical suspicion of the disease, TK2d is easily and definitively diagnosed by genetic tests. We are, therefore, engaged in 3 important areas of work: development of disease awareness and medical education programs to drive urgency to get genetic tests; laboratory partnerships to improve access to noncost testing and to ensure TK2d genetic testing is present on testing panels; and scientific and market research to understand and characterize the impact of this disease on patients, caregivers and families.

To conclude, this has been a very conductive and exciting quarter for Zogenix as we ramp up commercial activities for FINTEPLA and continue to advance clinical and regulatory programs for MT1621 and the new FINTEPLA indications.

So with that, let me hand over the call to Mike for the financial review. Mike?

Thanks, Steve, and good afternoon, everyone. Today, we issued a press release announcing our business and financial results for the first quarter ended March 31, 2021, which I'll now review.

We recognized $13.7 million in total revenue for the first quarter of 2021, which was an increase of 61% as compared to the $8.5 million recorded in the fourth quarter of 2020. This increase was the result of $11.3 million in product sales of FINTEPLA in the United States; $1 million in product sales of FINTEPLA in Germany; and $1.3 million related to our exclusive distribution collaboration with Nippon Shinyaku for FINTEPLA for Dravet syndrome and LGS in Japan.

Total net product sales of FINTEPLA of $12.3 million were an increase of 53% as compared to the $8.1 million reported in the fourth quarter of 2020. We recognized $1.2 million in total revenue for the 3 months ended March 31, 2020, a year ago.

R&D expenses for the first quarter were $31 million, a decrease as compared to $33.2 million recorded in the corresponding Q1 period of 2020. SG&A expenses for the first quarter ended March 31, 2021, totaled $31.2 million compared with $21.3 million for the first quarter of 2020. The increase of approximately $9.9 million was primarily driven by the investment related to the launch of FINTEPLA in the United States and in Europe and the preparations related to the commercial launch in other countries forthcoming in Europe in the coming year.

Net loss for the first quarter ended March 31, 2021, was $55.6 million or $1 per share. This compares to a net loss of $25.8 million or $0.54 per share in the first quarter ended March 31, 2020. We ended the first quarter with a strong balance sheet with cash, cash equivalents, marketable securities totaling $435 million.

With that, I'll now turn the call over to the operator to start our Q&A session. Operator, can you please open up the line for questions?

(Operator Instructions) Our first question comes from the line of Paul Matteis from Stifel.

So a couple. On the commercial side, it's encouraging to hear that you've had more in-person interaction as the pandemic wanes. Is there any way you can quantify that? What percent of your face-to-face meetings have been virtual versus in person over the past month or 2? And are you seeing any increase in volumes as a byproduct of it?

And then separately on LGS, just ahead of this pre-sNDA meeting, I was wondering, Steve, could you just set the stage a little bit. Is this more administrative? Or do you feel like you still need to kind of get reaffirmation that a single pivotal can serve as the basis for a filing?

Thank you, Paul. Let me take the LGS question first. Ashish, if you could get ready to address Paul's commercial question.

So regarding the pre-sNDA meeting. This is a standard meeting, first part of the development programs for an NDA. And I think we, like all other sponsors, really take advantage of as much time as we can to be in front of the FDA to ensure there's absolute clarity for the eventual NDA submission, to ensure that the review remains, hopefully, on track. So as we've mentioned in the past, we've had really good interaction with the FDA at the end of last year around the clinical package and the nonclinical package and really got agreements on what those would be.

So this is more administrative and more reaffirmation and confirming of our previous agreements. And as I mentioned, it's standard, it's helpful for both them and for us. It also gives us the opportunity to get initial feedback on what would be our proposed label for LGS. So there's a lot of upside to going forward with the meeting, and it's not going to impact the time line.

Over to you, Ashish.

Yes. Paul, in terms of the in-person interaction, it has been a recent trend in the last 3 or 4 weeks. And in terms of quantifying, I'll give you primarily a qualitative -- I'll say more than 60% or 2/3 of our key account managers have been able to go out in the field and call on their physicians.

There are certain pockets in the country who still are not allowing the pharmaceutical industry reps to come in. So those areas kind of still stay kind of off-limits. But we are hoping that they will start opening up because we are getting the appointments.

The other thing I would add is, we have been doing since we got in starting -- towards the end of March. We are doing now dinner programs in person. We are doing in-services in person. We just did a huge webinar which was attended in some places in person. So all of these things kind of going towards the positive trend.

And we are expecting that, that trend is continuing with patients coming and visiting the offices, and offices allowing more patients to come in. Because as you know, in some of these chronic conditions, the offices want to continue with the telemedicine because of the COVID risk. But as the vaccinations are increasing, we are seeing that in almost every part of the country. So more to come on that one.

Okay. Great. And would you mind just finally just quickly quantifying what gross to net was in the quarter?

Yes, I can take that. Paul, it's Mike. It's in the teens. So it's been in there since we started -- I think we eventually -- we're going to be -- we think eventually once we get the full patient population in over a year post launch, we'll be low 20s. But it currently has a little bit lower than that because commercial [comp] is coming up a little earlier than the public players.

Our next question comes from the line of Marc Goodman with SVB Leerink.

I guess one, can you give us just a sense of the average price that the patients who are on the therapy? That's the first question.

Second question is, what kind of color can you give us about how April has been? And just first week of May? Just trying to get a sense of how things are going relative to last time.

And then -- and lastly, you mentioned that off-label was, I think you said, 15% this quarter. What was it last quarter?

Thanks, Marc. I'll provide a little bit of color on sort of what's going on this quarter. And then Ashish, if you could take the question on average price and also these non-Dravet patients that we're seeing as well.

So just very simply, Marc, I don't think it follows what Ashish said in the previous -- in response to the previous question. We've seen a nice increase in rates of patients month over month in Q1. So in other words, we have more patients come into the REMS in March than we did in January. And we're seeing that trend in the early part of this quarter as well. So I think that just is a result of what Ashish talked about earlier.

And with that, I'll hand over to Ashish.

Yes. Thanks, Steve. Marc, in terms of the average price war on therapy, I would say it continues to be the same because, again, we are in the first year. But we are having more and more patients now getting towards that 0.5. The average dose now is around 0.5. So if you translate that into annualized, it's around 109,000. So that would be going forward rate it would be.

In terms of the patients on the indications other than Dravet, that's not -- like the overall is since the launch. So just to clarify my comment, I think that mid-teens number is what we have said is the entire population that has come starting from the launch till now. And if you recall earlier, we haven't really kind of separated that out. And when we did the analysis and everything, that number now looks in mid-teens. So that's why we are sharing it.

So the comment is that it's been pretty consistent, you're saying, since launch at 15%, is what you're saying? And I guess if that's true, just one follow-up, which is, are there LGS patients there? Or is this everything besides Dravet and LGS?

Yes. So -- yes, it has been consistent, that I can confirm. But the -- in terms of all the refractory epilepsies or the rare epilepsies that you see. And as you can imagine, majority of that is classified as LGS. So you see up to 2/3 of them in LGS and the rest in some of the other refractory epilepsies.

Our next question comes from the line of Tazeen Ahmad with Bank of America.

Congratulations on the quarter. As you prepare to file to the LGS application, wanted to get your thoughts, Steve, on whether you think that this is likely to get an accelerated path to approval? And some other examples of some CNS and other therapeutic areas, there have been some recent filings where expectations might have been set to accelerate and then FDA has granted a standard review. So I wanted to get your thoughts on that, and then I have a follow-up.

Yes. Thanks, Tazeen. I appreciate the question. I think where we stand at the moment is that we're going to do our best to put forward rationale to allow the FDA to determine the priority review for the supplemental NDA. And that's based upon what we are observing is that LGS is a very [interesting] and hard syndrome to treat. Despite the fact that the FDA have already approved 7 or 8 drugs for LGS, there's still an urgent unmet medical need, and we've heard loud and clear not only from physicians, but also importantly, from the patient advocacy groups as well. So we feel that it's in everyone's best interests to try and move forward with the priority review.

Having said that, the downside of that argument is that the FDA hasn't approved drugs (inaudible) and that might push them to a standard review, which will be 10 months. But as you know, it's benefiting to make our treatment justified, but ultimately it's their decision to make. But we will do our best to move forward with the priority review.

Okay. Great. And then as it relates to the launch, maybe Ashish can provide some color on how exactly -- like how important is it to be on formulary for a doctor to feel comfortable writing a script for FINTEPLA? Is it the case that even if it's not on formulary, doctors at this point feel like they understand what kind of paperwork they need to fill out, and that's not a rate-limiting factor for them?

Yes, Tazeen, thanks. I think it has not been a rate-limiting factor at all. I mean physicians in this particular space, as you know, in rare diseases, prescribe what is best for their patients. And in every conversation and the interactions we have had, that particular hasn't really come up.

The other thing to add there is we do have Zogenix Central, which is really geared up to support and the office staff as well as the physician into the entire process. And the staff there is really experienced in managing this process for the rare diseases. And so far, as I mentioned in my prepared remarks, we have had really good success. And that becomes a reference point for the physicians to look at but also be comfortable that this product will go through the entire process within 2 to 4 weeks and the patients will get the therapy.

Okay. And if I could squeeze in a last question. For patients that are onboarding that are -- the profile of the patients, do you know what percent of them have already tried Epidiolex?

It's -- we haven't broken that out, Tazeen, but as you can imagine, most of them would have tried Epidiolex or something else. What I can share with you is that we have seen, on an average, around 3 to 4 different antiepileptic drugs that they are on. And on a very worst case, we have seen up to 10. And as you know, FINTEPLA gets added to the therapy.

So even if the patient is on one of the CDD product or any of the other products, FINTEPLA will get added to that. And once the patient is stabilized, then they will start looking at, okay, what else they can do in terms of reducing the overall product burden.

Our next question comes from the line of Danielle Brill with Raymond James.

This is Daniil on for Danielle. Just very quickly, can you just help us understand what percent of patients that are enrolled in REMS end up on reimbursed drug? We're asking because it looks like last quarter, you had 550 patients enrolled in REMS. This quarter, you have 560 patients on (inaudible). Does that imply that 10 new patients enrolled in REMS actually got -- received reimbursed in 1Q?

Ashish, do you want to address that and explain the difference between the top of the funnel and the REMS? And then describe...

Yes. So in terms of -- when you add -- when you look at the patients going in, on the top of the funnel and then getting reimbursed therapy, you want to look at the absolute numbers. [I got 151] at the top of the funnel and around 145 plus at the -- which came at the end of the funnel. Because if you recall, at the end of Q4, we had around 415 patients on reimbursed therapy, and 550 patients were just enrolled into the program. And it takes around 2 to 4 weeks. So let's just say that it's 4 weeks. You're going to have that lag as patients come on to the therapy -- has come into the REMS program, and then they end in receiving the reimbursed therapy. I hope that helps understand the equation there.

(Operator Instructions) Our next question comes from the line of Tim Lugo with William Blair.

This is Lachlan on for Tim. So I was wondering how should we think about the change in productivity of the sales reps as they get more and more in-person interactions compared to the sort of virtual or digital world that we've been in?

And second question, if I may. Within the REMS-certified doctors that you have, how many of the potentially eligible patients do they have on therapy? So are most of them sort of trialing with 1 or 2 patients before expanding into the rest of the population? Or do they only have a few patients each?

Go ahead, Ashish.

Yes. Lachlan, thanks. I'll start with the second question first. So what we are seeing is, in terms of physicians who are prescribing, they are not only your thought leaders, but also the community physicians. And as you can imagine, if you have thought leaders who have a lot more patients, they are writing a lot, and we have -- if not majority, many -- most of their patients have been written on for FINTEPLA. And when you have community physicians, and I can tell you, as I said in my prepared remarks, almost 90% of our prescribers are coming from the community physicians who are not part of our clinical trial for the expanded access program and where we are seeing multiple prescriptions. So I think it's both.

Most of it is, and again, some of the places where they may not have written for all their patients or offered to all their patients because they haven't seen them, because of the COVID or because of the restrictions or the families who are not feeling comfortable going into a health care setting or even trying something else because of the COVID and any challenges that they may have with that.

So that kind of leads into your first question. I don't have a benchmark to talk about what change will be because we launched within the COVID. I think the only benchmark I can go back is to what we saw for the entire anti-epileptic class, where the new-to-brand prescriptions in the COVID environment went down almost up to 35% to 40%. And we will be doing every our effort to go back and go to every one of the physicians who have Dravet patients to educate them and make sure that they offer the product to their patients.

Our next question comes from the line of Yatin Suneja with Guggenheim Partners.

Okay. A couple of questions for me. In terms of the total sale, is there any European component to it? Can you tell us how much was the sale? What was the number in Europe? So that's number one.

The second question is just trying to get a sense of cadence of new patients at -- going forward and also trying to understand the dynamic in Q1. Because I think Ashish did mention that there were some leftover EAP patients that were added in Q1 or that got the drug in Q1. So it seems like the de novo patients are less than 150, so there seem to be -- it seems to be a little bit less than last quarter. So just trying to get a sense what the exact number was for de novo patient? And how should we think about cadence going forward?

Yes. I can take these for you, Yatin. Just on your second question first with respect to the cadence of the new patients, it was actually 150 de novo patients. So 151 de novo patients. So the early access patients were already in the REMS program and around 80%, 85% of them were already on reimbursed treatment by the end of last year and the final -- and the remainder were going to reimbursed treatment in this last quarter. However, they -- that's not -- they're already in the REMS, so they don't count against the new patients coming into the REMS.

And with respect to cadence, I just would reiterate what I said to Marc earlier. Of the overall number of patients we saw in Q1, we saw month-over-month increase in the rates, and we expect that will continue as we go through this quarter.

On the total sales of $12.3 million net sales, $11.3 million of that, as Ashish said, was in the United States and $1 million was in Europe.

Got it. And then I understand it's very early in the launch. Any color on the compliance or the discontinuation rate? And then maybe if you can comment on what the average weight per patient that you're seeing for Dravet patients?

Ashish, I'll ask you to address that question.

Yes. I'll start with the average weight. So the average weight we are seeing is consistent in what we saw in the expanded access program, around 35 kilograms. So you get the range there, but the average right now is 35.

And the compliance, as I said, or the persistence in the -- I said in my prepared remarks, that rate is around 93% at this point in time. So 93% of the patients who started, they are still under therapy. And again, it's very early, but as you know, at -- in the early expanded access as well as clinical trial, the discontinuations were around 10%.

So we expect that we will get there. But right now, I think we are seeing great results. Patients are seeing great results, and they are benefiting and then they are staying on the product.

The last question comes from the line of Neena Bitritto-Garg with Citi.

So just a question around the cardiac monitoring. And I guess at this point, you have some patients who have been on commercial drug for 6 months, so they would essentially be going now for their 6-month kind of echo. I guess how has that been going? Have there been any kind of issues in terms of getting patients in for the 6-month echo? Is that proving to be kind of -- or is that kind of proving to be as smooth as the baseline echos have been going?

Go ahead, Ashish.

Yes. Neena, I think in terms of the cardiac monitoring and the second echos, exactly as you said, it's been going smooth. We haven't had any challenges there and patients know that, families know that. And as you know, we have a really robust Zogenix Central program, which really reminds individuals, stays on top of it. We stay connected with the physicians, and we have many patients, a lot of patients. And as you know, some of the expanded access and the clinical trial patients who went onto the commercial therapy, they already had their echos sometime back in the past 6 months. So we have a lot of patients who have gone through their second echos, again, even -- since even last year. And every one of them have been able to get it in time and without any challenges.

Got you. Perfect. And I guess if I could just ask one more question quickly then. On the -- just kind of going back to the pace of new starts, I think -- thinking about the number of patients that were yet to kind of start on commercial drug rather than kind of the number of patients that were in the REMS. I think I calculated -- in the fourth quarter, there are about 160 or so FINTEPLA-naive new starts in fourth quarter and this quarter, it seems like it's closer to 100, just given that there were some patients still starting the drug from the EAP and the OLE.

I guess how should we think about the pace of new starts from here in terms of where that number could go? Understanding that, like you guys have said, there is this month-over-month increase. But I mean what's a reasonable number of new starts over the next couple of quarters?

Ashish, do you want to take that one?

Yes, I'll start. Yes, so Neena, we are not giving any guidance. But as Steve said in an answer earlier, the 151 that we saw, we have seen a consistent increase month-over-month, and we continue to see that as we move into the second quarter. So I think that would be one guidance, if you will.

And in terms of the Q4 as well as in Q1. In Q1, we did not have any patients from the expanded access program or from the clinical trial coming in. So everyone that you saw, that 151 that I said earlier, are all new to FINTEPLA. And every growth that's going to come for us is going to be from new patients to FINTEPLA.

Yes. So I'll just add a little color to that. So I think with new starts being -- they've been referred into program and then coming through and getting drug, which is pretty close to 100% level at this point, it's just a function of them getting covered and set up to get drug through the initial REMS screen and other elements that takes -- as Ashish says, basically taking roughly 3, 4 weeks.

The new starts are the patients that are coming in referred to the program. And we finished Q4, we had total around 100 -- between 150 and 160 and it's about the same -- pretty much the same number in Q1, although we had the impact of -- severe impact of the COVID pandemic through the holidays and through the January year. And as I'm sure you're familiar with, there are the restarting where people holding off in January to get new payer programs and whatnot. So you have your typical January starting, and we saw increasing throughout this quarter, month-to-month, and then also increasing and keeping up with increases into this quarter as well.

So we expect to be -- that increasing in the capacity for it to be less challenged by COVID. Also, for the balance of the year, too. So it's great to see that we were able to come through this quarter and what is standardly a lower demand quarter, lower start quarter because of a January impact and to maintain the pace that we were on and increase it by the time getting through the end of the quarter.

There are no further questions on the phone line. I'll turn the call back over to you.

Thank you very much, operator, and thanks to all of you for joining our call today.

The past quarter like -- this quarter like the past quarter has been incredibly active for us, and we're continuing to focus on advancing our commercial and clinical programs to bring (inaudible) critical new treatment options for patients facing serious unmet medical needs.

So really look forward to providing you with further updates on our activities throughout this year. Thank you all again for joining us on our call today, and enjoy the rest of your day. Bye now.

That does conclude the conference call for today. We thank you for your participation and ask that you please disconnect your line.