Zogenix, Inc. (ZGNX) CEO Stephen Farr on Q1 2021 Results - Earnings Call Transcript

Zogenix, Inc. (NASDAQ:ZGNX) Q1 2021 Earnings Conference Call May 6, 2021 4:30 PM ET

Company Participants

Brian Ritchie - LifeSci Advisors

Stephen Farr - Co-Founder, Chief Executive Officer, President & Director

Ashish Sagrolikar - Executive Vice President & Chief Commercial Officer

Michael Smith - Executive Vice President, Chief Financial Officer & Treasurer

Conference Call Participants

Paul Mateus - Stifel

Marc Goodman - SVB Leerink

Yatin Suneja - Guggenheim Partners

Tim Lugo - William Blair

Danielle Brill - Raymond James

Tazeen Ahmad - Bank of America

Operator

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

Brian Ritchie

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's 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.

Stephen Farr

Thank you, Brian, and good afternoon. I'm very pleased to be here with you today and to provide updates on what has been another exciting and productive quarter for the Gen X. Despite the operational challenges brought on by the ongoing pandemic commercial notice of things happen which are based in Germany, United States in Europe continue to progress well, as Ashish will describe shortly. We are very encouraged by the steady growth and 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 for example, and more patients wishing that effective dose, we see amount increased in the historic base and a beneficial impact on dosing tracks. We're never going to see an increase in the ability of field based teams to travel and meet with physicians and other healthcare 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 US and in Europe. Ashish, over to you?

Ashish Sagrolikar

Thank you, Steve. I'm very pleased to update you on our team's continued strong execution of the TensorFlow launch in the US 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 planned net sales in the US 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 center map. We have been really pleased with our ability to sustain this moment, despite significant COVID related headwinds. And in the US, 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 US growth in the number of healthcare professionals enrolling into the REMS program, the initial step and indicator of physicians interest in prescribing center plus remains robust. By the end of Q1, approx. 570 hcps were certified in our REMS program, with a majority already prescribing FINTEPLA. More than 90% of these prescribers are new. That is that did not participate in our clinical trial or expanded access program reflecting the broadening interest in prescribing FINTEPLA.

During the first quarter, About 151 new patients were prescribed FINTEPLA, which brought the total number of REMS referred and prescribed patients in the US to just over 700. This is a 27% increase since the end of 2020. Importantly, we saw a consistently increasing rate of new patient reference 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 when March 31, the number of patients receiving reimbursed FINTEPLA in the US 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 level studies and expanded access program.

We continue to be extremely pleased with the payer coverage can access for FINTEPLA. By the end of Q1, as covering more than 75% of U.S live had published a formal policy to cover FINTEPLA, as per label in on parity with other areas. With the rest of plans, covering it through prior authorization and medical necessity profits, due to the rare prevalence of rare syndrome in their covered population. Additionally, we successfully completed the coverage re verification process for all patients during the month of January, reinforcing Pierce's belief in FINTEPLA therapeutic value.

Since launch, the majority of FINTEPLA prescriptions in the US 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 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 calculation is similar to what we saw in the expanded access program, namely, approximately 0.5 milligrams per kilogram per day.

Although it is still very early in our launch, our retention rate continues to be very high that 93% consistent with our experience in the expanded access program, and clinical studies. As vaccination rates in the US increase, and restrictions ease more of our customer facing teams have been able to schedule in person interactions with SCPs 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.

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 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 us operation or AEU as we discussed earlier in this year. Access to FINTEPLA France will be under this AEU program until reimbursement negotiations are finalized. But I think that reimbursement negotiations across major European market such as United Kingdom, France and Italy are progressing well.

In April, we launched this version x axis 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 medicine pharma to make FINTEPLA available for patients in Israel. We are now working with our partners to prepare and file the regulatory and reimbursement documents for approval and covered us in Israel.

To conclude, we are very pleased with that more patients are now benefiting from treatment with FINTEPLA lab, 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?

Stephen Farr

Thank you, Ashish, for the great progress. Next, I'd like to update you on our pipeline, including FINTEPLA for a second a larger indication opportunity that [indiscernible] syndrome LGS as well as FINTEPLA with array of LGS in Japan. Our community and patient advocacy discussions reinforce the LTS remains one of the most challenging red 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 LGS followed by MMA fighting 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 earlier and phase three, and to align on the final electronic submission structure. In parallel, we were excited to report new clinical data for LGS in LGS and a podium presentation at the recent AAN [ph] 2021 meeting. These results from a pivotal clinical trial LGS showed the positive impact of each other on patient's ability to self-regulate behavior, emotions and cognitions. These non-seizure findings complement earliest phase three data analyses demonstrating that quintuplets significantly reduced drop seizure frequency, and notably the frequency of generalized tonic-clonic seizures that are a primary risk factor for sudden unexpected death in epilepsy. We believe these data combined with a novel mechanism of action relative to other approved therapies position FINTEPLA as a potentially important new treatment option for LTS patients.

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

Now turning to FINTEPLA in Japan. We remain on track for our plan JNDA submission for Dravet syndrome later this year. Separately, the last 33 patients will be randomized into our LGS study, which the pre NDA requested to enable the comparison responses in Japanese patients. So the multinational data from study 601 [ph] abroad a phase three trial. In addition to preparing LGS, we are also making great progress around the planning of our phase three trial in FINTEPLA in CDKL5 deficiency disorder, or CDD. As a reminder, Dr. Anda Vinski at NYU Langone Medical Center last year showed compelling data from CES investigator initiated study of several patients with CBD. We plan to discuss the final protocol with the FDA during this quarter unexpected beginning enrollment of CD 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 -- to further us patents in the orange book. This brings the total listed patents for FINTEPLA's attempt [ph] with appendix ranging from 2033 to 2039.

Now, I'd like to discuss MT1621. Our late stage investigational therapy for thymidine kinase two deficiency or TK2d. I'm excited to report our continued progress as we bring this therapy forward to a patient population with no approved treatments. Leveraging our data sets, demonstrating benefit in both morbidity and mortality in TK2d. We will pursue an indication encompassing all patients in our FDA file. Based on our discussions with the BMA 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 on-site group represents a minority of the population, an estimated 20% of all TK2d to the impatience, which has only recently been recognized and is less study. Non-offset patients represent the largest group of patients, and those with a clear high unmet need. Untreated disease and infant and childhood onset patients often results in loss of developmental milestones, or may progress rapidly to respiratory failure and death. All our studies required for the reference submissions are advancing as planned. And we remain on track to submit an NDA for MT1621 in the first half of 2020, to an NDA 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 under diagnosed. In the setting of critical suspicion of the disease, TK2d is easily a definitively diagnosed by genetic testing. We are therefore engaged in three important areas of work, development of disease awareness and medical education programs to drive urgency to get a genetic test, low priority partnerships to improve access to non-cost testing and to ensure TK2d see genetic testing is present on testing panels, and scientific and market research to understand characterize the impact of this disease on patients, caregivers, and families.

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

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

Michael Smith

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 recognize $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 record in the fourth quarter of 2020. This increase was a result of $11.3 million in products, the other FINTEPLA in the United States, $1 million in product sales within Tableau in Germany, and $1.3 million related to our exclusive distribution, collaboration with the Nippon Shinyaku for FINTEPLA, for jury syndrome and LGS in Japan.

Total Net product sales in FINTEPLA of $12.3 million, where an increase of 53% as compared to the $8.1 million reported in the fourth quarter of 2020. We recognize $1.2 million in total revenue for the three 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 total 31.2 million, compared with 21.3 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, with $5.6 million or $2 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, 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?

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes in line of Paul Mateus from Stifel. Please go ahead.

Paul Mateus

Hey, thanks so much as always for taking the questions always appreciate it. 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 two? 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 you know reaffirmation that a single pivotal can serve as the basis for a pilot. Thanks so much.

Stephen Farr

Thank you, Paul. Let me take the LGS question first. And Ashish, if you could get ready to address Paul's commercial question. So regarding the pre SNDA this is a standard meeting, as part of our development programs was an NDA. And I think we like all other sponsors, really take advantage of as much time as we can and to it doesn't have to be in front of the FDA, nor 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 had really good interaction with the FDA at the end of last year around the clinical package and the non-clinical 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 are a lot of upsides of going forward in the meeting, and it's not going to impact the timeline. Over to Ashish.

Ashish Sagrolikar

Yep. Hi, Paul. In terms of the in person interaction has been a recent trend in last year, four weeks. And in terms of quantifying I'll give you primarily a qualitative obviously more than 60%, or two thirds 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, we still are allowing the pharmaceutical industry loves to come in. So those areas can still stay 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 this we got in starting towards the end of March. We are doing our demo 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 officers want to continue with the telemedicine because of the COVID risk. But as the vaccinations are increasing, we're seeing that in almost every part of the country. So more to come up that one.

Paul Mateus

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

Stephen Farr

Yeah, I can take that. It's Mike. It's in the teens. So you know, it's been in there since we started, which I think will eventually we're going to be we think eventually once we get the full patient population in over a year, post launch will be in the low 20s. But it currently has a little bit lower than that because commercial is coming up will earlier than in the publication.

Paul Mateus

All right. Thanks.

Operator

Our next question comes in line of Marc Goodman with SVB Leerink. Please go ahead.

Marc Goodman

Just one, can give us just a sense of the average price that the patients who are on the therapy? That's first question. Second question is, what kind of color can you give us about how April's been and just, you know, first week of May, just trying to get a sense of, of how things are going relative to last time. And then lastly, you mentioned that off label was I think you said 15%. This quarter, what was it last quarter? Thank you.

Stephen Farr

Thanks, Mark. I'll provide a bit of color on, you know, sort of what's going on this quarter. And then Ashish, if you could take a question on average price, and also these nondairy patients that we're seeing as well. So just very simply, Mark, I think it follows what she said in the previous response, 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 are coming to the REMS in mass [ph] 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.

Ashish Sagrolikar

Yeah, thanks. Hi, Mark, in terms of the average price, who are 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 point five, the average dose now is around point five. So if you translate that into annualized, it's around 109,000. So that will be going forward rate it will be in terms of the patients on the indications other than driveway. That's not really the overall is since the launch. So just to clarify my comment, I think that means number is what we have said is the entire population that has come starting from the launch to mouth. 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 from within. So that's why we are sharing it.

Marc Goodman

So the comment is that it's been pretty consistent. You're saying since launched at 15%? Is what you're saying? And I guess that's true. Just one follow up, which is other LGF patients There is everything besides LGF.

Ashish Sagrolikar

Yeah, it has been sentenced and that I can confirm but the in terms of the it's all the refractory epilepsies of the rare epilepsy is that you see, and as you can imagine, majority of that is classified as LGS. So you see up to two thirds of them and LGS and some of the other refractory epilepsy.

Operator

Our next question comes in line of Tazeen Ahmad with Bank of America. Please go ahead.

Tazeen Ahmad

Hi, good afternoon. Thank you so much for taking my questions. And congratulations on the quarter as you prepare to file for the LGS application, wanted to get your thoughts, Steve on whether you think that this is likely to get an accelerated path to approval. In some other examples of some, you know, CNS and other therapeutic areas, there have been some recent filings where expectations might have been set to accelerated and FDA has granted a standard review. So I wanted to get your thoughts on that. And then I have a follow up.

Stephen Farr

Appreciate the question. I think, where we stand at the moment, we're going to our best to put forward rushing to allow the FDA to determine the priority review for the supplemental NDA. And that's based upon what we are observing. LGS is a very interesting, hard syndrome treat, despite the fact that the FDA have already approved seven or eight drugs for us. Yes, there's still an urgent unmet medical need. And we've heard we hear that loud and clear, not only composition, but also importantly from a patient, advocacy groups as well. So we feel that it's in everyone's best interest to try and move forward with a priority review. Having said that, you know, the downside of that argument is that the FDA hasn't approved drugs already knows. And that might push them to standard review, which would be 10 months, but unless you know, it's devastating to me, we can justify the ultimate decision to make but we will do our best to move forward with a priority.

Tazeen Ahmad

Okay, great. Thanks for the color Then as the relates to the launch, maybe Ashish can provide some color on how exactly like, how important is it to be, you know, on formulary for doctors to feel comfortable writing a script for FINTEPLA. Is it the case that even if it's not on formulary, you know, 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.

Ashish Sagrolikar

Yes, it was, it is not going to be a limiting factor at all. When submissions in this particular space, as you know, in rare diseases prescribe what is best for their patients. And then 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 version extension, 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, 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 two to four weeks, and the patients that get the therapy.

Tazeen Ahmad

Okay, and if I could squeeze in a last question, for patients that are onboarding that are, you know, the profile of the patient, you know, what percent of them have already tried up the dialects?

Ashish Sagrolikar

We haven't broken that out as input as you can imagine, most of them would have tried something else, what I can share with you is that we have seen on an average is around 3 to four different anti-epileptic drugs that they are on. And on a very worst case, we have seen up to 10. And as you know, quintuplet gets added to the therapy. So even if the patient is on one of the CBD 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.

Tazeen Ahmad

Okay, got it. Thank you so much.

Operator

Our next question comes in line of Danielle Brill with Raymond James. Please go ahead.

Unidentified Analyst

This is the Neal on the Danielle, thank you for taking the question. Very quickly, can you help us understand what percent of patients that are enrolled in REMS and upcoming reimbursed drugs? Asking because looks like last quarter you have 550 patients enrolled in REMS. This quarter, you have a 560 patients on pays draw does that imply that 10 new patients northern REMS received in both drug and one queue? Thank you.

Stephen Farr

Ashish do you want to addressed that and explain the difference between the top of the funnel in the REMS and then prescribe drugs?

Ashish Sagrolikar

Yes. So in terms of when you add when you look at the patient's going here on the top of the funnel, and then getting reimbursed therapy, you want to look at the absolute numbers at 151 at the top of the funnel and around 145 plus at the at the end of the funnel, because if you recall, at the end of Q4, we had around 415 patients on reimburse therapy and 550 patients who have just enrolled into the program. And it takes around to four weeks. So let's just say but it's four weeks. So you're going to have that lag as patients come on to the therapy as come into the REMS program, and then they end in receiving the reimburse therapy. Hope that helps understand the question there.

Unidentified Analyst

Thank you very much.

Operator

Our next question comes to the line of Tim Lugo with William Blair, please go ahead.

Unidentified Analyst

Hey, this is Laughlin on for Tim, thanks for taking the questions. So I was wondering how should we think about that 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 that we've been in? And second question, if I may, within the realm certified doctors you have, how many of their potentially eligible patients that they have on therapy, so most of them sort of trialing with one or two patients before expanding into the rest of their population? Or they only have a few patients each.

Ashish Sagrolikar

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 a thought leader who have a lot more patience, they are writing a lot. And we have, but in this, if not majority, many, most of their patients have been written on for center. And when you have community physicians can I can tell you that 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, we 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 are offered to all their patients, because they haven't seen them because of the COVID. Or because of the restrictions or the families who not feeling comfortable going into a healthcare setting, or even trying something else because of the COVID and any challenges that they may have with that.

But 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 best one I can go back is to what we saw for the entire anti-epileptic class, where the new two brand prescriptions in the COVID environment went down almost up to 35% to 40%. And we will be doing every RF to go back and go to every one of the physicians who have the patience to educate them, and make sure that they offer the product to their patients.

Unidentified Analyst

Awesome, thanks. Thanks for the color.

Operator

Our next question comes to the line of Yatin Suneja with Guggenheim Partners, please go ahead.

Yatin Suneja

Hey, guys, thank you for taking my question. Didn’t know I had to press one for I was pressing one by star so sorry about that. Okay, a couple 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, you know, cadence of new patients add going forward, and also trying to understand the dynamic in Q1, because I think I shoes did mention that there were some leftover EAP patients that were added in Q1, or that got the drug and Q1. So it seems like that they know where patients are less than 150. So there seems 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 denoble [ph] patients, and how should we think about cadence going forward? Thank you.

Stephen Farr

I can take this for us. And just on your second question first, with respect to the cadence of the new patients. There are actually 150 de novo patients. So what do you want to know about patients so the Early Access patients were already in the REMS program, and around 85% of them are already on reimburse treatment by the end of last year. And the final and the remainder went on to reimburse treatment in this in this last quarter. However, that's not they're already in the ramp so they don't count against the new patients coming into the reps. And with respect to cadence, I think I've just reiterate what I said to Mark earlier. The overall number of patients we saw in Q1, we saw muscle mass increase in the rate 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 servers in United States and a million was in Europe.

Yatin Suneja

Got it. And 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 rate per patient that you're seeing for drug patients

Stephen Farr

Ashish, I will ask you to address that question.

Ashish Sagrolikar

Yes, I'll start with the average weight. So the average that we are seeing is consistent in what we saw in the expanded access program around 35 kilogram. So you get the range there. But the average right now is 35. And the compliance, as I said, the persistence I said in my prepared remarks, that rate is around 93%, at this point in time, so 93% percent of the patients who started they're still on the therapy. And again, it's really early, but in the expanded access, as well as clinical trials, the discontinuations around 10%. So we expect that we will get there. But right now, I think we are seeing a great results. Patients are seeing great results, and they're benefiting, and then they're staying on the product.

Yatin Suneja

Thank you very much.

Operator

The last question comes from the line of Meena [ph] with Citi. Please go ahead.

Unidentified Analyst

Hey, guys, thanks for taking my question. The question around the cardiac monitoring. And, you know, I guess at this point, you have some patients who have been on commercial drug for six months. So they would essentially be going now for their six months. Kind of echo, I guess. How has that been going? Has there been any kind of issues in terms of getting patients in for the six months eco? Is that proving to be kind of? Or is that kind of proving to be as smooth as the baseline echoes have been going? Thanks.

Ashish Sagrolikar

I think it does serve the cardiac monitoring. And the second ecos that goes 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 version extension program, which really reminds individual’s 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 on to the commercial therapy, they already had the records some time back in the past six months. So we have a lot of patients who have gone through the secondary cause, again, even since we went last year, and every one of them have been able to get it in time and without any challenges.

Unidentified Analyst

Gotcha. Perfect. Thanks. And I guess if I could just ask one more question quickly, then on. Just kind of going back to the pace of new starts, I think, you know, 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 rooms. I think I calculated, you know, in the fourth quarter, there are about 160 or so quintuple 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 drugs from the EAP orally OLE [ph]. I guess, how should we think about the pace of new starts from here in terms of, you know, 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? Thanks.

Ashish Sagrolikar

Yep. So we will be 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, for as well as if you were 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, around new to FINTEPLA and every growth that's going to come for us is going to be from new patients to FINTEPLA.

Stephen Farr

Yeah, so I'll just add a little color. So I think with new starts being big they've been referred to in the program and then coming through and getting dry, which is pretty close to 100% level at this point, it's just a function of them getting covered and set up to get drugged through the initial REMS screen, and other elements that takes basically taking roughly three, four weeks, the new starts are the patients that are coming in referred to the program. And we finished Q4, we had total around 100 in 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 recent restarting where people are holding off in January to set new payer programs and whatnot.

So you had 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 you expect to be you know that increasing the capacity to for it to be less challenge by COVID. And also for the balance of the year to so it was great to see that we were able to come through this quarter and what is standardly lower demand quarters lower start quarter because of the January impact and to maintain the pace that we were on and increase it by the time getting through the end of the quarter.

Unidentified Analyst

Thank you.

Operator

No further questions on the phone line, I'll turn the call back over to you.

Stephen Farr

Thank you very much operator and thanks to all of you for joining our call today. This quarter like the past call has been incredibly active for us and we continue to focus on advancing our commercial clinical programs to bring [indiscernible] will be critical new treatment options for patients facing serious unmet medical needs. So I really look forward to guiding you with further updates and activities throughout this year. Thank you all again for joining us on a call today and enjoy the rest of your day. Bye now.

Operator

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