Conference Transcript - SUPN 2026-06-03

Andrew Tsai, Analyst — Jefferies

Okay, we're gonna get started with our next session. I'm Andrew Tsai senior biotech analyst at Jeffries And it's my pleasure to have Jack Qatar CEO of Sopernas to the right of me. Welcome Jack. Thank you morning, so Some people are maybe less familiar with the story So would could you just give us a brief overview of Sopernas where you are right now? Key priorities over the next year could also be helpful. Yeah, sure. Good morning, everyone

Jack Khattar, CEO

And thanks for joining us. Before I get started, just remind everyone, I'll be making forward-looking statements. So please check our SEC filings or all the risks associated with the business. So very briefly, a very brief overview. Sopernas is a CNS-focused company. We have a nice portfolio of growth products consisting of four key products in the portfolio. Our flagship product at this moment is Kelbri, which is a novel non-stimulant in the ADHD space. We launched it about five years ago. We're into year six right now. Zerzuve, which is a great product in the postpartum depression, the only oral product approved for the treatment of postpartum depression. That's about only a two-year-old brand, so fairly early in its innings as far as growth. And then Onapco, which is our subcutaneous infusion device of apomorphine for the treatment of advanced Parkinson's, a product that we launched in April. And GoCoverty, which also continues to be a growing product for us, although it's been on the market now eight years, and that's for the treatment of off-episodes and dyskinesia. So all in all, a very healthy, strong portfolio of growth products, which actually started delivering and delivered a record of the year for us in 2025, and now we are on a nice growth trajectory, 26 and beyond that.

Andrew Tsai, Analyst — Jefferies

And then speaking of your revenues, you know, current guidance of 840, 870, as we think about the peak sales potential of your four core products, I mean, where do you think your base business, your commercial products, can get you to in terms of peak sales? I totally no problem if you don't want to provide guidance or anything, but I'm just curious, directionally speaking, how much more do we have?

Jack Khattar, CEO

Well, I mean, collectively, you know, we've talked historically about Calgary, you know, can be in the multi-hundred million. You know, we're just scratching the surface with 900,000 prescriptions last year, which about one, not even 1% of the market. So there is a huge growth and it was a run rate of around 300 million already. So clearly, you know, Calvary can be multiple of that. And then there's UVE. It's a whole different market that is wide open for us, being the only product really marketed for that specific indication. It's a great product from a medical, clinical perspective. You know, can truly, and I believe that, we can truly become the standard of care in postpartum depression, given the unique profile of that product. And, of course, Onapco, a lot of excitement, Very excited about that segment in the Parkinson's space with the devices, infusion devices, which has become and will become a key segment in the marketplace that didn't exist, you know, before the launch of these couple devices. So, I mean, we're talking about probably a billion and a half plus in total, you know, on these products, if not more, clearly at peak, you know, not tomorrow, but at peak, yeah. Great, thanks.

Andrew Tsai, Analyst — Jefferies

And, you know, the Zeruwe product, to me, in retrospect to many people, it was a great deal. You essentially got it almost for, I shouldn't say for free, but you didn't spend too much is the bottom line. And you've been able to trim their expenses to have a positive ROI, essentially, already. And so, in terms of BD, I think in Q1 you had $380 million of cash. So, no debt. How much leverage can you use? How much firepower do you think you have to do more BD deals?

Jack Khattar, CEO

Yeah, BD continues to be a top, top priority for us. We are very focused on commercial type of assets. Second priority will be more like late-stage development type of products. As far as the bandwidth, I mean, we have a clean balance sheet, as you pointed out. We continue to build our cash position. So if it's a one-product situation, clearly in the 500, 600, you know, these are the kind of deals that we've done historically. But if it's a multi-asset situation, a company type of situation, and you have significant cash flows coming from these products, clearly you can go much higher, much bigger size, because you could use some leverage, you know, against very solid cash flow streams to support that. So, theoretically, I mean, it could be very big, again, depending on what that company is or target is, clearly. I mean, you could be in the billions, clearly, if that is supported by what you're buying, what you're getting.

Andrew Tsai, Analyst — Jefferies

And so, shifting to one of your key growth products on APCO, and we'll definitely touch on Calabria and so forth, Azuwe after. but on Apco launched April 2025 there was a technical hiccup in October but you did get it resolved in February congratulations and so we're kind of on we're trying to get back back to you know back and growing more basically so what's your current thinking about the peak sales potential of this product and then fundamentally there's just you know another advanced Parkinson's product from Avi Viola how are you are you at least how competitive do you think you are compared to that product because that products guided to do a lot

Jack Khattar, CEO

more than what maybe you've got it yeah I mean I mean the two products fundamentally are very different as far as first of all the drug in that product and that in that pump you know we are a we have apomorphine the other product is more of a pro drug of levodopa carbidopa so clearly the patient profile could be very different and that is emerging as time goes on and we're getting more and more data as time goes on as to who is that patient but that's very relevant to what the potential is could be behind these two products our product can be used adjunctively with oral levodopa carbidopa in the other case you have to replace the oral carbidopa levodopa so it all depends on what the physician is looking for that specific patient you know what are they looking to solve for If you're a patient who's been diagnosed for a long time, you've used oral medications for a long time, including levodopa, carbidopa, you're really hitting a ceiling as far as to the incremental benefit you're getting. You might decide as a physician, say, okay, this patient has to move on to something else, and therefore ONAPCO would be an ideal, you know, solution for that. Or you could be a patient only two, three years or four years into the diagnosis. you are struggling with the current oral medications and you might say as a physicians look I will try still levodopa carbidopa but a different delivery system and that could be then you know you go to the other products so depending on the situation and that is something that is evolving because this is a segment as I mentioned earlier we're building it together you know the two companies together and you're gonna also have patients who prefer one product versus the other, because there are some key differences between, aside from just the drug, whether the issue of convenience, wearing it at night, not wearing it at night, the pump is bigger, smaller, you know, there are all kind of differences between the two products. But all in all, it looks like it's a very promising category that is evolving within the Parkinson's space, and we're pretty happy to be part of it, clearly. And yes, I mean, we are rebounding, as we talked about it, you know, not a long time ago, our earnings call have started the rebound from the supply in a situation that we went through and we were pretty happy to see some of that already reflected in the March. And I talked about a couple of these metrics back then. So continue to see that momentum building in the score.

Andrew Tsai, Analyst — Jefferies

Right. And so April, May, how do you feel about that trajectory? We kind of look at the script data. It is growing. Is it to your expectations, to your liking, and, you know, come June, July, and so forth, do you expect a stronger acceleration?

Jack Khattar, CEO

Yeah, I mean, I can't, of course, speak to the quarter, you know, specifically as far as to what we expect, the results or whatever, but certainly the data is pointing to, as I said, you know, continued momentum, continued acceleration in the rebound, in the business. I mean, April, we had, you know, some solid numbers that are even above March. March was a record number on prescriptions. April was even better than that, although it's a shorter month. So things are pointing in the right direction. I mean, at this point, you know, we will talk about guidance specifically or the potential for this year, more probably in the August timeframe when we announce the results of the second quarter. You'll have a full quarter after the supply situation. So you have a much better idea where we're going to land, you know, for the full year.

Andrew Tsai, Analyst — Jefferies

And in terms of start forms, the bottom line is, like, it looked healthy in terms of the monthly start forms that you're adding. And so is there, the short of the question is, there should be no reason to believe it slows down, the pace of the start forms, right? Because Parkinson's is a very big market, basically.

Jack Khattar, CEO

Yeah, I mean, at this point, it looks like it's, you know, pretty much in line with what, you know, we've been talking about and what we've been reporting, you know, for the last few quarters. So that continues to be the case from a demand perspective. Clearly, in this quarter and when we started back after the supply, we've been also dealing and working through the backlog that has developed because of the supply situation You know, we had a lot of patients waiting in the queue, you know, to be processed through. So we've been working through that backlog and clearing that, while at the same time, of course, adding new, you know, new forms and new patients into the process. So actually, you want to continue to have a healthy number in the queue, of course, because that means you continue to replenish, you know, the funnel, so to speak, as you get people out of the funnel with shipments and initiations.

Andrew Tsai, Analyst — Jefferies

And the 2,200 cumulative start forms since the beginning, I think that was as of April, what percentage of those patients do you think ultimately get converted to a paying product?

Jack Khattar, CEO

Dr. Yeah, I mean, typically what we see is somewhere in the 45 to 50 percent from form to shipment. And this is a little bit slightly above, slightly above, you know, industry average. Every case is very different depending on the patient population, what medication you're dealing with in these specialty you know product space in this situation it's actually probably one of the most complicated situations because you have the device you have everything else that you have to process as well as you have the nurse side of it at the end with the initiation to set that up and that sometimes takes time and adds some time to that process but we're pretty happy where it is but there's areas always areas for improvement and we're always looking for you know different stress points so to speak within that process where we can improve and speed up the process because we don't want patients waiting for too long right unfortunately yes we do lose patients in the process people don't want to wait anymore or or things go sideways now a lot of the waiting time unfortunately is also people or patients are unreachable believe it or not you know you try to reach them we need information that's missing on the form or there are questions about insurance or whatever it is and you just don't hear from the patient back I mean there are all kind of reasons why people fall

Andrew Tsai, Analyst — Jefferies

out of the process I see but stress points one of them being maybe the nurses and specialty pharma that's something you can control it sounds like is it improving direct like maybe talk us through that aspect yeah yeah

Jack Khattar, CEO

absolutely I mean you know we're going back to normal so to speak you know out of the supply situation march was the first really full months which we did well and we continue to do as well if not better you know from that perspective um so it's like think of it as like a machine right you stopped everything everything was stopped for three four months now you're re-priming the machine and you're restarting so it's going to take time for everything to grow back to the full momentum that it had before and you know i guess it answers my

Andrew Tsai, Analyst — Jefferies

next question because I do get asked you do have 2200 cumulative I understand it's from the very very beginning but quote-unquote only like 570 patients in the queue as of April like why not more was the is a line of questioning but I guess you would respond with these stress points is that right okay and the attrition you know do yeah yeah okay and so ultimately how should we think about about compliance rates and discontinuation rates for this product?

Jack Khattar, CEO

Yeah, I mean, what I can point you to is really the experience in Europe, for example, because the product has been in Europe for so many years. And what we've seen, different surveys and different studies that have been done following patients, you know, on that product, they've seen patients, basically it ranges from being on the product for six months or all the way to six years, you know, depending on the situation. So it really varies what we saw on the infuse on study, clinical study, for example, discontinuations were more in the 25 to 33%, 20, you know, around that range. So we don't have really very solid data yet because we've been only in the market since April, but the real patients on the product probably since June or July, you know, last year. So we need more data to really see whether we're falling into these kind of numbers. I mean, I don't see a reason why it would be too different. You know, it's the same product. Medical, clinical, performance, everything should be pretty close to what the European experience has been, you know, for years.

Andrew Tsai, Analyst — Jefferies

Got it, and so to be crystal clear, as we think about the uptake so far, there's no more supply issue. You have plenty of supply with the first supplier to handle whatever demand you're seeing right now, full stop.

Jack Khattar, CEO

That's right. I mean, the current supplier and based on that is the guidance we gave. I mean, obviously, we gave that guidance based on the current supply situation. And try to remind folks, you know, guidance is not just based on supply. It's based on supply, based on the demand that we just talked about, based on the way and the ability to be able to fulfill that demand, you know, process that demand. So it's several variables. It's not just the supply.

Andrew Tsai, Analyst — Jefferies

right and you know q1 sales again q1 was it when your disruption was happening still I think it was like 8 million and change for q1 your guidance for the full years 845 to 70 it's cut fairly wide range but regardless sales would need to accelerate on a quarterly basis and you're confident that's going to be

Jack Khattar, CEO

the case in q2 q3 yeah I mean we certainly need to accelerate between q2 in Q4 I mean you know as time goes on you have less months you know to get to these numbers and I mean at this point as recent as obviously a couple weeks ago when we did the earnings call you know we didn't change the guidance so obviously we still believe that is something that is achievable you know

Andrew Tsai, Analyst — Jefferies

got it and so as you're you're I guess as momentum builds then you're working on a second supplier that you've said you're going to file an SNDA in third quarter of this year and so maybe speak to your confidence in getting the second supplier approved in 2027 because maybe demand you know accelerates even further in 2027 so we want to make sure you're able to handle

Jack Khattar, CEO

yes yeah I mean as far as the timeline we communicated you know a few weeks back on the submission in the third quarter I mean it's coming up third quarter is not too far away so We feel pretty good about that, you know, as far as the submission. And then the rest is in the FDA's hands, so to speak. You know, typically it's a six-month review. It could be a little bit longer because there is an inspection here that has to be scheduled by the FDA. Now, this is a European facility that has been inspected numerous times by the EU. The product is supplied to the European market. We don't expect, really, issues. but you know you never know until they walk into that facility and do the inspection we've been to that facility it's really a great facility we have inspected it ourselves but all that has to fall in line and that's why we gave the guidance that at the latest by mid-year 2027 we should get that approval and I did mention you know a few times before that the capacity of the second supplier you know is adequate more than just adequate it's actually multiple of the current supplier so we will be in a good position in 2027 with now two suppliers clearly with the ability you know to provide us with

Andrew Tsai, Analyst — Jefferies

product got it and then last question on a go just bigger picture you do have the apokin pen go covery all for Parkinson's and on a go can you describe the treatment journey how these products are used yeah sure I mean when you first

Jack Khattar, CEO

get diagnosed typically most of people get on levodopa carbidopa oral as you start increasing the dose of levodopa carbidopa because the disease is progressing you start getting the need for adjunctive therapy and a lot of the orals which are adjunctive I mean one of them is Zedago which is another product we have in Parkinson's GoCovary is another one obviously now GoCovary is used a little bit later because then you start hitting the skin easier and GoCovary is the only product approved for off episodes and dyskinesia. So that's where a lot of physicians start adding GoCovary to get rid or reduce the dyskinesia that is caused by a lot of these medications. And then Apocin is more on an as-needed basis because it's a bolus injection that you get. So it has a different positioning in the marketplace for people who have the need or are feeling that an off episode is coming up. They can take an injection, or they may want to have an injection, you know, it's portable. They can carry it with them. They are at a big event, and they expect an off episode. They can make sure they feel assured that they can take that injection because it works pretty quickly. It really gives you relief pretty quickly. And then, of course, on APCO, we talked about it, which is more later in the disease state. So each one of these four products, actually, in Parkinson's that we have are fairly uniquely positioned for a different, you know, need. Yeah. No cannibalization. Okay. Very good. Well, between Apocin and Onapco, there might be some cannibalization because people who might take Apocin four or five times a day, they might opt for the pump. Understood. Understood. Okay. Very good.

Andrew Tsai, Analyst — Jefferies

And then shifting to Zeruva, your other growth driver, it's just growing nicely. If I were to characterize it, it is growing linearly. Is there, what's your confidence that it could accelerate on a quarterly basis? I mean, after all, I think you and Biogen, your partner, have started DTC ads, too. I could be wrong about that, but yeah, shape of the curve would be helpful.

Jack Khattar, CEO

Yeah, I mean, one thing about Zerzuve, which is, you know, more historical background behind to help people understand is, you know, the indication got approved, but the Biogen and Sage back then, you know, they didn't really have the time to prep the market, do the education that typically you do it two years before you launch, you know, you get dissemination of a lot of the scientific data, you get people understand the product, the use of the product, who is the patient potentially. That work was not done before the launch, so it's being done during the launch. It's like building the plane and flying at the same time, so to speak. So we've been doing a lot of catch-up together with our partner, Biogen, a lot of investment in education, building the market. And I'm talking about both sides of the market, meaning on the health care provider and the patient side, because a lot of education has to occur on the patient side, and that's why we embark on the DTC campaign. You'll be amazed how low the awareness is on the postpartum depression, that even the disease exists. Actually, we have around 78% to 80% of our patients who are diagnosed with postpartum depression. That's the first time ever they've heard about what postpartum depression is. So, I mean, awareness is very low on the consumer side. Not so much on the healthcare provider side, but on the healthcare provider side, it's more training and allowing and arming, specifically OBGYNs, giving them the tools, the confidence the knowledge to screen diagnose for postpartum depression I mean that is not an area that they go to medical school and get trained in you know they go to medical school and get trained in delivering babies or doing other things obviously but not necessarily treating depression so we try to provide them with these tools the confidence the knowledge and actually we have you know good data that shows once a physician and OBGYN gets that comfortable and takes that first step in treating the first patient they tend to be repeat riders and of course it's also kudos to the product itself because the product works I mean the product works within the third day you start feeling the difference and within 14 days it's a 14-day course of therapy and you're done and it's very different of course then the old or existing standard of care which is SSRIs that typically take weeks and weeks to even titrate to a dose that you don't know what that dose is because there has never been studies on SSRIs to treat postpartum depression so as a physician you're just guessing you don't know what the dose should be or need to be and you're titrating for weeks and during that process what's happening mom is suffering the family is suffering and they're going you know needlessly and unnecessarily through you know the stuff times instead of giving them something that could start working within day three and in 14 days it's done right so that's really the profile

Andrew Tsai, Analyst — Jefferies

super helpful and so bigger picture how where are we in terms of the current market penetration in PPD and where do you think that yeah I mean everything

Jack Khattar, CEO

every year 500,000 women suffer from postpartum depression about only half of them get diagnosed you know 45 actually to 48% get diagnosed and out of those who get diagnosed only 60% maybe 70% get treated and since we launched the product about two years ago we have treated about 29,000 a little bit more than 29,000 patients so clearly we you know we're still on the very early you know innings here on the product and the potential of this product and really getting deeper penetration into the marketplace so there is a lot of room for us especially if also we can move the needle on the diagnosis the treatment side of it and then move the needle on you know getting people to move away from SSRIs and go to a product that is truly designed developed

Andrew Tsai, Analyst — Jefferies

studied and approved for postpartum depression right right and so Sage actually had a pipeline of interesting molecules so the question is within the next one or two years can we expect you to introduce something to the

Jack Khattar, CEO

Superna's pipeline from that yeah I mean we we have been through the portfolio we've done the evaluation and we have you know prioritized in a certain programs within what used to be the sage portfolio we've consolidated that with our own portfolio on the discovery side because we have our own discovery engine and R&D like SPN 443, which came out of that effort. So, yeah, I mean, theoretically, possibly in a year or two or whatever, you know, we could potentially start talking a little bit more about some of the things that are percolating, although, you know, obviously those things will be still in early stage, you know nothing late stage but there's there's some you know really exciting things from a scientific perspective that they were working on and some of it actually was never disclosed publicly so at the right time with some real data you know we could just start disclosing some of that okay great and

Andrew Tsai, Analyst — Jefferies

so just going then Calbri your flagship product just some housekeeping questions it's just growing nicely each year maybe just remind us what your key priorities are for 2026 for Calvary second half as well as 2027 in terms of growing volumes and I don't know is it more about a volume game than price at this juncture because maybe gross to net no longer approves that much over time

Jack Khattar, CEO

yeah I mean it is really a volume you know situation and will continue to be that way I mean the gross to net is kind of now more in the steady state equilibrium status you know unless you have some one-off quarterly event that could swing it one way or the other and you know that's the 50 to 55 percent target that we have you know talked about and from a volume perspective we're very happy with the trends on the prescription growth I mean it continues to deliver high double-digit growth in prescriptions we're very happy and excited about the growth specifically in the adult segment the adult segment is is the high-growth segment in ADHD and has been for years now. It is the largest segment, so we believe, you know, we can do pretty well there. The product has a great positioning in the market in the adult space. And, you know, last quarter it grew by around 27% in prescriptions in adults, so we're very pleased with that. And we have also significant DTC effort, you know, through social media influencers. So more and more people are stepping up and talking about ADHD, talking about the issues that they deal with, and that's been very helpful in raising the awareness. And actually, that's why the market in general, interestingly, for several years now since the pandemic has been growing in the 8 to 9 percent. You know, there are not too many CNS large markets that have been growing at that clip from a prescription point of view. So all in all, a lot of awareness on the mental health side, specifically with ADHD, also in the adult segment. And we've published a lot of data, specifically when it comes to adults. You know, we have two phase four studies that we published, one on co-administration of Calbri with stimulants. And actually, our business in adult, about 40% of it is combination therapy with the stimulant. And then also the impact and potential impact of Calbri on comorbidities as well. There is another study that we published, you know, ADHD with depression, ADHD with anxiety. And, you know, we have significant improvements on not just ADHD, but also the other aspects of mood disorders. And that is important in the adult population. That is something we cannot promote, actually, obviously, and we don't. But it is a lot of questions that we got from the scientific community that we had to answer, and at least that data would give them some answers. Male Speaker 1

Andrew Tsai, Analyst — Jefferies

Got it. Got it. And you said earlier this should be hundreds of millions at peak in terms of peak sales. that consider competitors in non-stimulants? I think Osuka has centafinidine coming with a Pidufa in July and then Axone's working on Cynosin. Who knows if it's a non-stimulant at the moment but the point is competition in the non-stimulant class is coming so are you nervous or are you okay kind of thing? I mean in general we're known that we don't mind

Jack Khattar, CEO

competition. Competition can be great, can be very good, keeps on your toes, keeps keeps you on edge, keeps you, you know, sharp, you know, and so forth. And also, in certain situations, competition can be very helpful from that perspective because depending on what the product, you know, excuse me, depending on what the product is, is it a non-stimulant, is it a stimulant? I mean, we welcome other companies talking about non-stimulants, you know. We're the only ones making a lot of the noise in non-stimulants, and non-stimulants have been this small segment, 10%, 12% of the market for years. So another company building that awareness and the importance of non-stimulants, not necessarily a bad thing. Understood. Okay. Well, that's all the time we have.

Andrew Tsai, Analyst — Jefferies

Thank you, Jack, for all the updates.

Jack Khattar, CEO

Thank you.