Good to see you. Yeah. It's been a while, but yeah. Okay, we're going to get started with our next session. I'm Andrew Tsai, Senior Biotech Analyst at Jefferies, and it's my pleasure to have Jack Khattar, CEO of Supernus, to the right of me. Welcome, Jack.
Thank you. Good morning.
Some people are maybe less familiar with the story, could you just give us a brief overview of Supernus, where you are right now? Key priorities over the next year could also be helpful.
Yeah, sure. Good morning, everyone. Thanks for joining us. Before I get started, just remind everyone, I'll be making forward-looking statements, so please check our SEC filings for all the risks associated with the business. Very briefly, a very brief overview. Supernus 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 Qelbree, which is a novel non-stimulant in the ADHD space. We launched it about five years ago. We're into year six right now. ZURZUVAE, 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.
Onapgo, which is our subcutaneous infusion device of apomorphine for the treatment of advanced Parkinson's, a product that we launched in April. GOCOVRI, 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. All in all, a very healthy, strong portfolio of growth products, which actually started delivering and delivered a record year for us in 2025, and now we are on a nice growth trajectory 2026 and beyond that.
Great. Speaking of your revenues, current guidance of $840 million-$870 million. As we think about the peak sales potential of your four core products, where do you think your base business, your commercial products can get you to in terms of peak sales? Totally no problem if you don't want to provide guidance or anything. I'm just curious directionally speaking, how much more do we have?
Well, collectively, we've talked historically about Qelbree can be in the multi-hundred million. We're just scratching the surface with 900,000 prescriptions last year, which are about not even 1% of the market. There is a huge growth, and it was a run rate of around $300 million already. Clearly, Qelbree can be multiple of that. ZURZUVAE, 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. I believe that we can truly become the standard of care in postpartum depression, given the unique profile of that product.
Of course, Onapgo, a lot of excitement, very excited about that segment in the Parkinson's space with the infusion devices, which has become and will become a key segment in that marketplace that didn't exist before the launch of these couple devices. We're talking about probably $1.5 billion + in total on these products, if not more, clearly at peak.
Yeah.
Not tomorrow, but at peak. Yeah.
Great. Thanks. The ZURZUVAE 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. 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?
Yeah. BD continues to be a top priority for us. We are very focused on commercial type of assets. Second priority will be more late-stage development type of products. As far as the bandwidth, we have a clean balance sheet, as you pointed out. We continue to build our cash position. If it's a one-product situation, clearly in the $500, $600, these are the kind of deals that we've done historically. 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 against very solid cash flow streams to support that. Theoretically, it could be very big.
Again, depending on what that company is or target is, clearly, and you could be in the billions, clearly, if that is supported by what you're buying.
Right
What you're getting. Yeah.
Right. Okay, shifting to one of your key growth products, Onapgo, and we'll definitely touch on Qelbree and ZURZUVAE after. Onapgo launched April 2025. There was a technical hiccup in October, but you did get it resolved in February. Congratulations. We're trying to get back and growing more, basically. What's your current thinking about the peak sales potential of this product? Fundamentally, there's just another advanced Parkinson's product from AbbVie, VYALEV. How competitive do you think you are compared to that product? Because that product's guided to do a lot more than what maybe you've guided.
Yeah. The two products fundamentally are very different as far as, first of all, the drug in that product and in that pump. We have apomorphine. The other product is more of a prodrug of levodopa carbidopa. 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. 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. It all depends on what the physician is looking for that specific patient. 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," therefore Onapgo would be an ideal solution for that. You could be a patient only two, three years, or four years into the diagnosis. You are struggling with the current oral medications, you might say as a physician, "Look, I will try still levodopa carbidopa but in a different delivery system." That could be then, you go to the other product. Depending on the situation. That is something that is evolving because this is a segment, as I mentioned earlier, we're building it together, the two companies together.
You're going to 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. There are all kind of differences between the two products. 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. Yes, we are rebounding, as we talked about it not a long time ago at 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. I talked about a couple of these metrics back then.
Continue to see that momentum building in this quarter.
Right. April, May, how do you feel about that trajectory? We look at the script data. It is growing. Is it to your expectations, to your liking? Come June, July, and so forth, do you expect a stronger acceleration?
Yeah. I can't, of course, speak to the quarter specifically as far as to what we expect the results or whatever. Certainly the data is pointing to, as I said, continued momentum, continued acceleration in the rebound in the business. April, we had 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. Things are pointing in the right direction. At this point, 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. You have a much better idea where we're going to land for the full year.
Sure. In terms of start forms, the bottom line is it looked healthy in terms of the monthly start forms that you're adding. 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.
At this point, it looks like it's pretty much in line with what we've been talking about and what we've been reporting for the last few quarters. That continues to be the case from a demand perspective. 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 where we had a lot of patients waiting in the queue to be processed through. We've been working through that backlog, and clearing that, while at the same time, of course, adding new forms and new patients into the process. Actually, you want to continue to have a healthy number in the queue, of course, because that means you continue to replenish-
Right
The funnel, so to speak, as you get people out of the funnel with shipments and initiations.
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?
Yeah. Typically what we see is somewhere in the 45%-50% from form to shipment. This is a little bit slightly above industry average. Every case is very different depending on the patient population, what medication you're dealing with in the specialty 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, that sometimes takes time and adds some time to that process. We're pretty happy where it is, there is always areas for improvement, we're always looking for 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 things go sideways. A lot of the waiting time, unfortunately, is also people or patients are unreachable, believe it or not. 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. There are all kind of reasons why people fall out of the process.
I see. Stress points, one of them being maybe the nurses and specialty pharma. That's something you can control it sounds like. Is it improving directly? Maybe talk us through that aspect.
Yeah. Absolutely. We're going back to normal, so to speak, out of the supply situation. March was the first really full month, which we did well, and we continue to do as well, if not better, from that perspective. 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.
Right
To the full momentum that it had before.
I guess it answers my next question, because I do get asked, you do have 2,200 cumulative, I understand that's from the very, very beginning, but quote unquote, "Only 570 patients in the queue as of April." Like, why not more? Is a line of questioning. But I guess you would respond with these stress points. Is that?
That's right.
Okay.
Stress points and the attrition during that.
Yeah.
Yeah.
Yeah. Okay. Ultimately, how should we think about compliance rates and discontinuation rates for this product?
Yeah. 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 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, depending on the situation. It really varies. What we saw on the InfusiON study, clinical study, for example, discontinuations were more in the 25%-33%, around that range. 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.
Last year. We need more data to really see whether we're falling into these kind of numbers. I don't see a reason why it would be too different.
Yes.
It's the same product.
Yes.
Medical, clinical performance, everything should be pretty close to what the European experience has been for years.
Got it. 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. Is that fair?
That's right. The current supplier. Based on that is the guidance we gave. Obviously we gave that guidance based on the current supply situation. Try to remind folks, 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, process that demand. It's several variables.
Right
The supply itself.
Right. Q1 sales, again, Q1 was when your disruption was happening still. I think it was like $8 million and change for Q1. Your guidance for the full year is $45 million-$70 million. It's fairly wide range. Regardless, sales would need to accelerate on a quarterly basis and you're confident that's going to be the case in Q2, Q3, Q4?
Yeah. We certainly need to accelerate between Q2 and Q4. As time goes on, you have less months to get to these numbers. At this point, as recent as obviously a couple of weeks ago when we did the earnings call, we didn't change the guidance, so obviously we still believe that is something that is achievable.
Got it. 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. Maybe speak to your confidence in getting the second supplier approved in 2027, because maybe demand accelerates even further in 2027, but so we want to make sure you're able to handle-.
Yeah, sure.
The second supplier.
Yeah. As far as the timeline, we communicated a few weeks back on the submission in the third quarter. It's coming up. Third quarter is not too far away, so we feel pretty good about that as far as the submission. Then the rest is in the FDA's hands, so to speak. Typically, it's a six months 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 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. All that has to fall in line.
That's why we gave the guidance that at the latest by mid-year 2027, we should get that approval. I did mention a few times before that the capacity of the second supplier is adequate, more than just adequate, it's actually multiple of the current supplier. We will be in a good position in 2027 with now two suppliers clearly, with the ability to provide us with product.
Got it. Last question on Onapgo, just bigger picture, you do have the APOKYN pen, GOCOVRI, all for Parkinson's on Onapgo. Can you describe the treatment journey, how these products are used?
Yeah, sure. When you first 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. A lot of the orals, which are adjunctive, one of them is XADAGO, which is another product we have in Parkinson's. GOCOVRI is another one, obviously. GOCOVRI is used a little bit later because then you start hitting dyskinesia, GOCOVRI is the only product approved for OFF episodes and dyskinesia. That's where a lot of physicians start adding GOCOVRI to get rid or reduce the dyskinesia that is caused by a lot of these medications.
APOKYN 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. 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. Of course, Onapgo, we talked about it, which is more later in the disease state. Each one of these four products actually in Parkinson's that we have are fairly uniquely positioned-
Right
For a different need in the market.
Yeah. No cannibalization. Okay, very good.
Well, between APOKYN and Onapgo, there might be some cannibalization because people who might take APOKYN four or five times a day, they might opt for the pump.
Understood. Okay. Very good. Shifting to Zurzuvae, your other growth driver. It's just growing nicely. If I were to characterize it is growing linearly. What's your confidence that it could accelerate on a quarterly basis? After all, I think you and Biogen, your partner, have started DTC ads too. I could be wrong about that.
Yeah.
Shape of the curve would be helpful.
Yeah. One thing about ZURZUVAE, which is more historical background behind it to help people understand, is the indication got approved. Biogen and Sage back then didn't really have the time to prep the market, do the education that typically you do it two years before you launch. You get the 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. It's being done during the launch. It's like building the plane and flying at the same time, so to speak. We've been doing a lot of catch-up together with our partner, Biogen, a lot of investment in education, building the market.
I'm talking about both sides of the market, meaning on the healthcare 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%-80% of our patients who are diagnosed with postpartum depression. That's the first time ever they've heard about what postpartum depression is. 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 OB-GYNs, giving them the tools, the confidence, the knowledge to screen, diagnose for postpartum depression. That is not an area that they go to medical school and get trained in.
They go to medical school and get trained in delivering babies or doing other things, obviously, but not necessarily treating depression. We try to provide them with these tools, the confidence, the knowledge. Actually, we have good data that shows once a physician, an OB-GYN, gets that comfortable and takes that first step in treating the first patient, they tend to be repeat writers.
Of course, it's also kudos to the product itself because the product works. 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.
Right.
It's very different, of course, than 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. 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 needlessly and unnecessarily through the tough times, instead of giving them something that could start working within day three and in 14 days it's done.
Right.
That's really the profile.
Super helpful. Bigger picture, where are we in terms of the current market penetration, in PPD?
Yeah
Will get to?
Every year, 500,000 women suffer from postpartum depression. About only half of them get diagnosed. 45% actually-48% get diagnosed. Out of those who get diagnosed, only 60%, maybe 70% get treated. Since we launched the product about two years ago, we have treated about 29,000 or a little bit more than 29,000 patients. Clearly, we're still on the very early innings here on the product and the potential of this product and really getting deeper penetration into the marketplace. 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 getting people to move away from SSRIs and go to a product that is truly designed, developed, studied, and approved for postpartum depression.
Right. Sage actually had a pipeline of interesting molecules. The question is, within the next one or two years, can we expect you to introduce something to this Supernus pipeline from that?
Yeah. We have been through the portfolio. We've done the evaluation, and we have prioritized 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. Theoretically, possibly in a year or two or whatever, we could potentially start talking a little bit more about some of the things that are percolating.
Obviously those things will be still in early stage, nothing late stage. There's some really exciting things from a scientific perspective that they were working on, and some of it actually was never disclosed publicly. At the right time, with some real data, we could just start disclosing some of that.
Okay, great. Then Qelbree, 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 Qelbree second half, as well as 2027, in terms of growing volumes. I don't know, is it more about a volume game than price at this juncture? Because maybe gross to net no longer improves that much over time kind of thing.
Yeah. It is really a volume situation, and will continue to be that way. The gross to net is kind of now more in the steady state equilibrium status, unless you have some one-off quarterly event that could swing it one way or the other. That's the 50%-55% target that we have talked about. From a volume perspective, we're very happy with the trends on the prescription growth. 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 the high-growth segment in ADHD and has been for years now. It is the largest segment, we believe we can do pretty well there. The product has a great positioning in the market, in the adult space. Last quarter, it grew by around 27% in prescriptions in adults.
We're very pleased with that. We have also significant DTC effort through social media influencers. More and more people are stepping up and talking about ADHD, talking about the issues that they deal with. That's been very helpful in raising the awareness. Actually, that's why the market in general, interestingly, for several years now since the pandemic, has been growing in the 8%-9%. There are not too many CNS large markets that have been growing at that clip from a prescription point of view.
All in all, a lot of awareness on the mental health side, specifically with ADHD, also in the adult segment. We've published a lot of data specifically when it comes to adults. We have two phase IV studies that we published, one on co-administration of Qelbree with stimulants. Actually, our business in adult, about 40% of it is combination-.
Oh
Therapy with the stimulant. Also the impact, and potential impact of Qelbree on comorbidities as well. That is another study that we published, with ADHD, with depression, ADHD with anxiety, and we had significant improvements on not just ADHD, but also the other aspects of mood disorders. That is important in the adult population.
That is something we cannot promote actually, obviously, and we don't.
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.
Got it. You said earlier this should be hundreds of millions at peak, in terms of peak sales. Does that consider competitors in non-stimulants? I think Otsuka has centanafadine coming with the PDUFA in July, then Axsome's working on solriamfetol. Who knows if it's a non-stimulant at the moment? The point is, competition in the non-stimulant class is coming, so are you nervous or are you okay kind of thing?
In general, we've known that we don't mind competition.
Yeah.
Competition can be great, can be very good. Keeps you on your toes, keeps you on edge, keeps you sharp, so forth. Also, in certain situations, competition can be very helpful from that perspective because depending on what the product excuse me, depending on what the product is. Is it a non-stimulant? Is it a stimulant? We welcome other companies talking about non-stimulants. 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. Another company building that awareness on the importance of non-stimulants, not necessarily a bad thing.
Understood. Okay. Well, that's all the time we have. Thank you, Jack.
Thank you.
For all the updates. I appreciate it.
Thank you. Appreciate it.