-annual healthcare conference. I'm Stacy Ku, part of the biotech team with my colleague Vish Shah, and we're happy to be hosting Supernus today. We have Jack Khattar, CEO of Supernus. We also have Tim in the back, CFO, Timothy C. Dec. Thank you both for joining, and Peter Vozzo as well. There. Thanks for joining. We just had the earnings update last week. Before we drill down into maybe all the different individual products, do you wanna start off with some opening remarks on the performance for Q4 and what expectations you all have for 2026?
Yeah, yeah, sure. Good afternoon and thanks for joining us. Just before I get started, just to remind everyone that I'll be making forward-looking statements, please check the risk factors associated with the business in our SEC filings. Overall, I mean, you know, Supernus is in a very different place today than we've ever been.
What I mean by that is, we have an incredible portfolio of products, more specifically four of them that are growth products. We're not any more a one product kind of story. Clearly we've come a long way, we just managed through the LOEs of some of our legacy products. Moving forward, we're looking at accelerated growth. We have an exciting pipeline, two launches, so to speak.
We're in the middle of them with ONAPGO, and ZURZUVAE is only two years old. I mean, these are products that are still very young. Qelbree, which has been, you know, doing phenomenally well, will be in year six, and even with that, it's not slowing down. GOCOVRI, which is nine years old, and still growing at double digits. It's, it's been really a great reshaping and remaking of the portfolio over the last couple years, and we're really happy with what, you know, what's to come, yet to come as far as the company's, you know, future. Of course, on the pipeline, we have couple great assets that are in phase II-B as well. Yeah.
Okay. Wonderful. Clearly as we look to this year, folks do like to look at one clear growth driver, to simplify the story, and of course, that does lead to many investors focusing on the ONAPGO launch. Last week, you did announce the reinitiation of treating new patients, so following the supply disruption. Maybe just remind folks, what were the issues, what's now been resolved, and how to look forward?
Yeah. Back in early November, you know, we disclosed and announced that we have supply constraints, and the issues we were facing is with the current supplier. We had capacity issues where we couldn't get enough production. It's not a line that is dedicated to our product. We share it with a lot of their clients. Given, at the same time, the overwhelming demand of the product, that became, you know, a bottleneck. We did what we believed was the right and is the right thing to do, which is to stop new patient initiations.
We had to prioritize patients, of course, and make sure that whatever supply we had at that time will take care of the patients who are and were existing patients for us at that time, until we work through these constraints, you know, that we have on the supply side. Since then, clearly we've made progress with our current supply.
We have a production schedule for this year, deliveries and so forth, that gave us the confidence to say, "Okay, now we can go back and start patient initiation." In the meantime, during that time, although we had supply constraints, we were obviously very transparent with physicians, the KOL, the whole community, and despite that, they continued to submit, you know, initiation forms for new patients. They submitted somewhere around 500 patient forms at that time.
That gave us a very good indication that the demand is there, no question about it, because even during such a constrained time, difficult time, physicians continue to believe that there is a need for the, you know, for this product for a lot of their patients, and they continue to submit forms.
Now we're back to what somehow normal, kind of operation, you know, initiating patients and so forth. We do have a backlog, of course, of many patients in the process, that we need to work through that backlog. As time goes on, of course, we continue to refill the funnel with more and more forms as time goes on. We're pretty excited to go back to normal, so to speak.
Okay. We have gotten some questions around the Q4. Obviously, you had some clinician additions to the level of prescribing, but also around 500 patient start form adds. Would you characterize that as the type of patient demand in light of supply disruptions, as we think about maybe the number of patients that were added in Q3?
I mean, absolutely. That is really very reassuring for us, you know, that the demand is there, and will continue to be there. We've said it many times. I mean, this is a product that like no other product in this space. It is apomorphine. It's not a levodopa carbidopa-based product.
Physicians, patients, they need other alternatives other than just another levodopa carbidopa, and that's really what the basis is behind this demand. The product delivers and is a great product, you know, once you use it, and we've seen that in Europe for decades actually. I mean, this is a very validated clinical and medical approach with this type of product, with apomorphine, and has been validated for years in the European markets. We're not right now really surprised that the demand, you know, is really sticky and will continue to be there for us.
Okay. If we're reading between the lines, you seems like you're suggesting that a lot of these patients, and again, we know it's very early days, we'll add the caveat, but it seems like a lot of these patients that were part of the start form queue, they seem to have wanted to wait through the supply disruptions and not, and maybe not trial a competitor. Is that a fair way to describe the dynamics you're seeing?
Yeah. I mean, patients will stay with us. The thing I would like to remind folks is the 1,800 forms, that's really the demand, right? They're not gonna all translate to patients, and we need to you know, keep that in mind because you always have attrition during that process.
From the time you process a form, that's when you get even a completed form, half the time you don't get a form that is completed, it's half completed. It takes even time to finish the information on the form, you'll be surprised how long that takes sometimes. Get these forms to the hub services, the hub processes them through insurance and everything else, to the pharmacy, the product gets shipped.
Even when the product gets shipped to the patient, it takes a week or two sometimes to schedule the initiation visit because we do initiations in person, in-house with the patient, not in the physician's office. We don't do it virtually, we do it in person, and that's the kind of service, you know, we're offering our patients. Naturally, across that whole spectrum, you're gonna have some patients that fall off for one reason or another.
That's fair. Maybe let's start with the foundation of patients that we have so far. I would say in the Q3 update, you talked about maybe those initial 400 patients. For that base, are you learning about the different, I guess, use patterns from this clinician, the prescribers? Sorry, the patients. From the patients, are you learning more about how frequently they're using the product? What type of patient profile? Are they more moderate versus severe? Obviously, this is a spectrum of disease.
Mm-hmm.
it's a bit of a gray area as we're trying to figure out exactly where ONAPGO fits in.
Yeah. We started actually collecting some good data right before the supply interruption. Clearly that interrupted or disrupted some of the collection of that data as time goes on. Yes, there is a picture that's starting to emerge and that is, you know, a lot of these patients initially, at least initially, are what you would expect.
These are patients who are on levodopa carbidopa. Some of them, many of them are on other oral adjunctive agents. They're still struggling. I mean, they still face a lot of off episodes during the day. They're not able to keep up with all these medications. Something that is an infusion device that give them subcutaneous continuous delivery of a drug like apomorphine is very beneficial to them.
These are the type of patients we're seeing. As far as usage, you know, we think is our assumption, which is about one cartridge a day probably is about the right. You know, you're gonna have, of course, some patients that may end up using a little bit less, a little bit more.
On an average, we're seeing that's probably a good assumption, you know, which is about a cartridge a day. As time goes on, we're gonna learn more and more, and we'll fine-tune some of these assumptions. At this point, that's the kind of patient profile that is looks like it's emerging at this point.
Okay. you also talked about the 700 patients that are in the queue for processing currently. Sounds like behind the scenes, the company is working on really making sure access reimbursement is all established. How long does that take to kind of get into the funnel for ONAPGO?
I wish I do have an answer because obviously we just started that whole process, and we don't know what we're up against. There are a couple of things that, you know, remind folks that we are in Q1, which is not your best time of the year. The second thing is a lot of these patients in 2025 may have had a different insurance company or a different coverage, and now we're in 2026.
There is a lot of re-verification that has to occur, re-verification of the insurance benefits, re-verification from a process perspective. I truly don't know whether we'll end up, for example, processing 30 patients a week, 40 patients a week, 100 patients a week. We truly don't know. At the same time, you know, we have also, you know, a certain amount of resources.
I mean, I don't have like, you know, 500 nurses that can initiate 700 patients tomorrow in one day, right? Naturally, these patients are all at different stages. It's gonna work itself out because not everybody is at the same stage at the same time. Some patients are about to get a shipment, so obviously they'll get the shipment, they get initiated.
In the meantime, some patients are halfway through the process. They're all at different stages. I would expect, I mean, by May, you know, when we talk about first quarter results, we should have a much clearer idea, clearly, on these 700 patients, how many have been cleared through, so to speak. Maybe by then, we'll have more than 700 because we keep filling the funnel.
I mean, it's not like the 700 are being processed and we are done for the year. Clearly, you know, that's going to continue to grow as we continue to get the demand on the product.
You talk about all the different friction points when it comes to fulfillment, but obviously that suggests a higher level of awareness of maybe being able to provide drug to the patient in Parkinson's disease. You also have your GOCOVRI network, so you understand what a like white glove specialty service needs to look like. Maybe just help us understand very high level that 1,800 patients, how it transitions in terms of fulfillment.
I mean, I mean, if you're looking for a specific conversion rate, let's call it, right, from the 1,800, how many people end up being real patients? I mean, historically, on other products like the ones you named, GOCOVRI or APOKYN, I mean, typically, you would expect you might lose somewhere between 15%-25%. I mean, that's a rule of thumb. It fluctuates.
It changes every time you look at it, but that's basically, you know, how much typically you lose out of that. Which is unfortunate because these are all real patients, and you work so hard to get these forms, but that's unfortunately, you know, the system we have, you know, from a reimbursement, insurance, all that.
We always are looking at the process and the different bottlenecks or friction points or whatever you wanna call them and see how we can streamline it more and how can we avoid that and how can we, you know, make it quicker so the patients get to their therapy much quicker.
Okay. Okay. When it comes to then, as a company, you all don't typically produce or give us product-specific guidance, but you did give some type of range for us, which is between $45 million-$70 million for ONAPGO. Just help us understand the different scenarios underpinning this range, especially as we think about this patient start forms and the number of kind of your comments around fulfillment-
Yeah.
does suggest it could be somewhat conservative. Just help us understand the dynamic?
Yeah, I mean, this is a question I've been pretty much asked all day long. In most of the one-on-ones, you know. Why is it 70? Why is it 45, you know? What's the difference between the two? Rightfully, very important, good question, of course. I mean, like every other guidance, you have the upper end and the lower end.
For one. It's not because of one specific reason that you might hit the upper end or you may miss the upper end, and you end up with the lower end of the range. There's always a variety of reasons that get into the mix. It's supply, it's demand, it's the fulfillment that we just talked about, the rate of processing, the speed of processing of these forms, and so forth. It's the nurse support.
I mean, there's a lot of pieces that get to the picture, you know, to finally initiate a patient and ship a product to them and so forth. It's all that together. You know, we're obviously much more confident today than we were in November, and I did share that with a lot of folks before, you know, we got to this point, that we will not give people an update until we have more confidence that we can actually provide product.
We are at that point. Do I have 100% certainty, 100% confidence as I would have in December 2026? No. In December 2026, I can tell you whether I got every delivery, and I got every batch I'm expecting, and the yield and the quality and everything falls in place, right?
That happens on every product we have. I mean, you know, that's called pharmaceutical manufacturing. You know, that's what it is, and that's what we deal with on a day-to-day basis. All these factors are built into the equation that led us to come up with that range. Is it 45-70? Could we do more? Yeah, that is a possibility too. I mean, could we do less? Hopefully not. I don't think so. Could we do more?
I mean, that's always a possibility, but with all the information we have today, that's really the best guess we can come up with now, you know, based on some of the data, initial data we've had from a production perspective, demand perspective, and the resources that we have and are able, you know, to marshal to work through the backlog and get as many patients as possible.
Okay. You also have made a point of you do need two to three weeks for the sales force to truly relaunch the product for you to get more conviction around the cadence of the year.
Yeah, I mean, everybody is like restarting, so to speak. Yes, absolutely. You need a little time to get to that momentum that we used to have or we were at back in August, September last year.
Last comment on manufacturing. Clearly, you're talking about a second supplier, which should come on board for next year. Sounds like you're going to have clarity in the next month or so around what type of review. Just help us understand the different potential pathways forward.
Yeah, I mean, these are typically what we call CMC type of packages that you have to submit. You have to be able to show the FDA that the new site, manufacturing site/supplier is able to produce the product on a repeated basis, produce some batches, do the testing, and create a package that has all the data. That data will include stability data, include specifications, release testing, all that.
You submit the package, they review it, the FDA has to inspect that facility because that facility is in Europe. It's not in the U.S. This will be pretty much the first FDA-approved product, so to speak, you know, for them to provide the U.S. They need to schedule that. I don't have specific timeline right now.
As we mentioned at the earnings call, I mean, we continue to talk with the FDA, discuss with them. We should have clarity in a month or so, you know, as to what kind of timing. Typically, it's six months, maybe nine months, again, all depending on when is the inspection gonna occur, you know, for that facility.
We're very hopeful, and we're optimistic that definitely in 2027. The issue, is it early 2027? Is it mid-2027? Clearly, by May of this year, we'll, you know, we'll have a much better, clearer idea what that is. Regardless, we expect the current supplier to bridge us to that no matter when it is in 2027.
Okay. Understood. As we then think about, again, sounds like you're waiting for a few more Factors before updating your views on APCO peak sales. Maybe talk about net pricing really quickly before we talk about the potential total addressable market. Is it fair to say right now expectations are around $105,000 wholesale acquisition costs, and then remind us the dynamics around gross to net for this year and where you expect to stabilize?
I mean, the $100,000-$105,000, which is on a WAC basis, you know, as a annual cost per patient, is based on the assumption that I mentioned earlier, which is about 1 cartridge a day, you know, as far as usage. It looks like that's about right in the right zip code so far from everything we know. As far as the net pricing, I did mention on the earnings call, it's probably gonna be in the twenty, I mean, long term. Again, it's gonna fluctuate initially until things settle down, but it's gonna be in the 20%-30%. Of course, it gets on the higher end of that range in like Q1 and so forth, like typically, and then it improves over time.
I mean, that's where we are on leg recovery, APOKYN, you know, we're in that area, so I expect this to be pretty close to that from a net pricing. I mean, that's, you know, that is something obviously that will become much clearer over time, whether there is a more need for, you know, contracting or not. We don't have contracting.
We've had really good coverage on the product from day one, actually, on the commercial side and the Medicare side, we've been able to process and go through these insurance claims and so forth. So far, so good. You know, it's mainly on the Part D side, so right now. We'll see how it, you know, it evolves over time, but it shouldn't be, you know, above 30.
Okay. Maybe some nuance around your current views on peak sales? You previously guided to $200 million or $300 million.
Yeah.
So...
I mean, we were going to issue another. We're gonna do, you know, a refresh, so to speak, on the forecast given the overwhelming demand that we had that was, you know, above expectation. All these metrics got disrupted with the supply constraint and the pause that we had to take, right?
Could I safely today, could I safely say, well, it'll probably be above $200? You know, because the range we gave $200 to $300, maybe it's closer to the $300. Maybe I can say that, but I truly don't have, you know, full trends on a lot of the metrics for us to come up with a, you know, reasonable, you know, reassessment, so to speak. I know everybody expects it to be higher.
Everything we've seen leads us to believe, yeah, probably it is higher than the initial, you know, estimates we put out there. But do I have a new number? Do I have a new model that Well, the model is missing a lot of metrics that I would have, you know, I would have had by now if I didn't have the supply disruption. But we'll issue something at the right time. Absolutely.
Okay. Understood. We obviously in the, in the background have a lot of assets that in the past have gotten intense scrutiny, including Qelbree. Obviously, now we're seeing what we believe to be steady growth. How are things progressing for you all as you think big picture? Is it really the adult segment that you think is gonna drive growth in the near term? The pediatric adoption seems to continue to be very strong. Just help us understand those nuances, obviously, as it relates to this going forward.
I mean, Qelbree's been great. You know, it's been a great launch. We are always launching a product. That's always our mindset on all our products, you know. The product delivered another incredible year last year, although we're getting into year six, you know, this year on the life of the product. The growth continues to be on both segments, patient population. I mean, we grew phenomenally well on the adult side, but we continue to grow very strongly on the pediatric side, which is keeping the mix, interestingly, in the 70% to 30%, you know, or 35%, 65%.
'Cause people are always asking me, "Well, did the mix change?" Well, the good news is it changed, and the good news is it didn't change because it changed from the fact that the adult continues to grow phenomenally well, but pediatric is growing as well, and therefore the mix continues to be very stable.
We're happy where Qelbree is, and it certainly has a long way to go. 935,000 prescriptions last year is nothing in a market that has 111 million prescriptions. You know, the non-stimulant segment is very much underutilized, and there is a lot of potential for it. I mean, no kid should be put on a stimulant if they have another option like Qelbree. You can always try Qelbree within a week.
We're not asking you to wait six, seven, eight weeks like Strattera used to. You know, you have to wait to see whether it works or not. Within a week or so, you'll know whether this product will work for you or not. Why on earth, as a parent, would you put your kid on a stimulant? It just makes no sense. That's really the message out there.
You know, there is a great real alternative that works. You don't have to put your kids on controlled substances that are classified like narcotics, and that's what it is. With Qelbree, you can have a great product that works well. Then for adults, and we've, you know, presented a lot of that data, I mean, this is a product that helps also significantly in situations where you have comorbidities. We did a phase IV study.
You know, it's not a full-blown, well-controlled, placebo-controlled study, obviously. Because we kept getting the question from physicians, "Well, can I use it with comorbidities?" Comorbidity meaning ADHD with depression, ADHD with anxiety, and so forth. We did that study and the data speaks for itself. I think there is tremendous areas of growth for us on Qelbree, and I always say we don't need to get 10% of the market. You know, we're happy with 4%, 5%, and that would be hundreds and hundreds of millions of dollars as a potential.
As we look to 2026 dynamics, anything specific you'd like to flag for Qelbree?
Our continued execution. I mean, it's really, We still have a long ways to go on the penetration. Just continued education and you know, pushing the product. This is promotion sensitive. Our sales force has been tremendous in really targeting and how you target makes a big difference on the execution side. Just continue to do what we've been doing.
Okay. Understood. With the ZURZUVAE launch, we obviously get a really broad spectrum of reactions when the acquisition was announced.
Uh-uh.
Clearly you all really did not spend too much when it came to finding the value in the product. Now moving forward, just maybe help us understand the level of investment that you're learning is required. Sounds like you're working with Biogen. Maybe talk about these first initiatives to really relaunching the product. And with a lot of space in between because folks, I think are giving you the necessary space to try and grow the product.
I mean, ZURZUVAE is an incredible product, we're so happy to have it. It's been a great acquisition, you know, so far and great collaboration with Biogen, we're actually investing more this year than ever before. We'd initiated a DTC campaign with Biogen because there is so much education that has to occur with women and patients out there.
I mean, it's amazing. 80% of patients, of women who get diagnosed with postpartum depression, they've never even heard about the disease. I mean, that's the lack of awareness education. That's to what extent it's out there that there is such a great need, we felt this is the right time for us, you know, to really make women aware of this disease. This is something that they shouldn't feel guilty or ashamed or anything like this.
This is not their fault. It's a hormonal issue. You know, they could be coming forward and talking to their OBGYN, discussing, you know, what they're going through. Because a lot of times today, what happens is these symptoms are mixed up, and they're confused, and people think it's fatigue, it's lack of sleep, it's stress, it's anxiety, you know, with the newborn and everything that's.
They get overwhelmed and all that, and they confuse the real symptoms, which is really depression, postpartum depression with these other things. It's very important for women to be able to realize that and step forward. In parallel, if they do, they go to an OBGYN who's actually now trained on how to screen, how to diagnose, and how to treat the disease. We're doing both in parallel.
We'll continue to invest in that because historically, what people don't realize is this product was launched without much preparation initially for the launch. Typically, two, three years before you launch a product, you set the market, you prepare it, you do the education. Well, that didn't happen in this case because initially they thought the product was gonna approve for MDD, not PPD.
Now they ended up launching the product and at the same time doing the market education, and therefore, more and more of that needs to continue to happen because it could have, you know, happened. This is not to fault anybody, just the way things, you know, ended up. Yeah.
You believe that's probably the most key underappreciated aspect of the ZURZUVAE launch.
I mean, you have 500,000 women every year who have these symptoms. We just treated only 20,000 in two years, and the product did, what? $195 million combined, you know, as the full alliance. I mean, there is a long way to go here. And the alternatives, I mean, SSRIs, I mean, you're asking women to wait for weeks to even titrate them to find the right dose, and whether it's gonna even work or not.
Really, that's what you want our patients to go through for weeks and weeks of this misery and unfortunate sadness and feelings of isolation and all that? Do you want a product that within three days starts working, and in 14 days it's all done? I mean, it just, it's just incredible, you know. I mean, the alternatives are really not great. With ZURZUVAE, we think we have a great opportunity here to be and become the standard of care in this space.
Okay. Wonderful. In the last few moments, you obviously have behind the scenes a pipeline that's progressing. You also openly talk about your interest in business development. Just help us understand how you're trying to balance all the different products as you're bringing the company forward.
Yeah. I mean, we're strong believers in both R&D and M&A, and that has been our philosophy since we built the company way back because none of these areas will always come to fruition as you would like it at the timing you want it. You know, science doesn't always work the way you would like it, and M&A opportunities are not always available when you want them.
You have to always be working in parallel, and we emphasize both. On a BD side, our priorities haven't really changed. We continue to emphasize revenue-generating opportunities, and short of that, and second priority is later-stage assets that are much later than our own pipeline. It doesn't make any sense to bring in another phase I program or phase II. Obviously, we have plenty of that activity going on internally at Supernus.
That's really on the M&A side and CNS, psychiatry, neurology, movement disorder. We're very agnostic which area it is. Now, of course, also women's health is another area that we're given that we have a presence in the OBGYN space. On the R&D side, we're very excited about SPN-817, SPN-820. Most likely data in 2027. We're not gonna get any data this year. Let these phase II-B studies, you know, run their course and then, I mean, both molecules are very, very promising in their respective areas.
Okay. Looking forward to seeing all the progress this year.
All right.
Thank you very much.
All right. Thank you.
Thank you both, Nan.