Good afternoon, ladies and gentlemen. I'm Rahul Sood, Managing Director in the Healthcare Investment Banking Group at Wells Fargo. I have the pleasure of hosting Jack Khattar, CEO of Supernus Pharmaceuticals. Jack, welcome.
Thank you. Thanks for having us.
I heard that you've had a slow summer. You just announced the largest and the most transformative transaction in Supernus' history. Can you tell us a little bit about the company you're building and the opportunity you see in front of you?
Yeah, sure. Good afternoon, everyone, and just a quick reminder that I'll be making forward-looking statements, so please check all the SEC filings for the risks associated with our business. For those of you who are familiar with us at Supernus, for a long time now, we've been building the company based on couple strategies, primarily in R&D, investment in R&D, and also doing transactions from external growth perspective, bringing products into the portfolio so we can continue to secure future growth behind the company. We've done that extremely well over the years. From an R&D perspective, our R&D capability has been actually proven over the years. We have about 12 products. I know not a lot of people know probably that 12 products that are marketed that have been developed by Supernus, before the Shire team, technology, scientists in our own facilities and so forth.
Some examples of that are like the Adderall franchise, which at one point it was a $1.4 billion franchise, came from our technologies and capabilities. Other examples like Orenitram for United Therapeutics, which is actually a $500 million franchise right now in the marketplace, and so forth. Then we employed these capabilities and will continue to develop our own products. We started with Oxtellar XR, Trokendi XR as an epilepsy migraine franchise, and that was actually at peak around the $500 million, generated significant cash for the company that allowed us to continue to build, and be able to do outside transactions.
In combination with the M&A, we were able to manage the LOEs, the exclusivities of Trokendi XR, Oxtellar XR, which we just basically finished that transition phase, allowed us to have new products in the mix, which are developed internally by our R&D capabilities like Qelbree, as well as bringing high growth products like ZURZUVAE and ONAPGO and even GOCOVRI to a certain extent that came through M&A. So by employing these two strategies, we will continue to build the company moving forward, and continue to plan for LOEs. You're always going to have LOEs in pharma. That's part of life in our business, clearly. You have to always be ahead of it and be able to employ strategies in the right way and execute on them to be able to get future growth into the mix.
That's how we've been successful so far in being able to hold the line on revenue, even in the last couple of years, losing $300 million, $400 million on Oxtellar XR, Trokendi XR. We're able to hold the line on revenues despite all that, continue to launch products, invest in R&D, and even maintain profitability at the same time.
Great. Jack, can you talk about your approach to CNS? There are different verticals within Supernus today and going forward. Can you talk about your commitment to each of those verticals?
Yeah, we've been focused on CNS right from the beginning. Some of it goes to our heritage when we were part of Shire Pharmaceuticals. Naturally, we had a lot of experience in the CNS space. For example, ADHD, there is no company in the industry that have developed more products in ADHD than Supernus. We've developed Adderall, ADDERALL XR, MYDAYIS, Intuniv, and now Qelbree. So we're very experienced in that space, specifically ADHD, epilepsy, migraine, and so forth. Given our heritage when we started Supernus, we decided to stay with that focus. A lot of these diseases are chronic diseases that lend themselves to some of the capabilities we had early on back then.
Right now, our portfolio is pretty much focused on both ends on the neurology side, the movement disorder through our Parkinson's portfolio, and then on the psychiatry side with ADHD and postpartum depression, which is the new asset that we brought in last year through the Sage acquisition. We'll continue to be as focused as possible. Now, of course, ZURZUVAE got us. It is a CNS product, postpartum depression, but also interestingly gave us a little bit a leg in the women's health space, and we did say that is an area we will continue to look for potential possibilities. If we can expand in that space, we will be willing to do that, given that now we have a good infrastructure, a good sales force, and presence in that space.
Understood. Just switching gears a little bit, your first half results have been strong. Revenue was up 32% in the second quarter, and your four growth products were up over 50%, and you raised the full year guidance to $860 million - $890 million. What's working better than your expectations for this year?
Well, in a way, better in the sense, clearly we are now at a stage, as I mentioned earlier, the LOEs are behind us. We are at a stage where our portfolio is picking up from a growth perspective, accelerated growth phase. We are in that phase where our growth is accelerating behind basically three and a half or four growth products.
Primarily Qelbree, of course, which is currently our flagship product. ONAPGO that we launched only about a year and a half ago. XADAGO, which is still very early in its growth stage, only it was launched two and a half years ago. All these products are contributing to that trend, to the health of the business, and to the robustness of the growth that we've been able to deliver. That's why we had a pretty strong first half. We're pretty happy with that, really, and very excited. Of course, third quarter is always exciting quarter for us because Qelbree back to school, the momentum over there that typically carries us through the fourth quarter and try to finish the year pretty strong on that brand.
Great. Let's talk about the Qelbree and the ADHD franchise for a couple of minutes. Qelbree has become one of the more successful CNS launches that I can think of the last five years. You did about just shy of $90 million of revenue in the quarter, which was up 15% on more than 250,000 prescriptions. Tell us about the franchise and where do you see it going from here?
A big picture for us, if you look at the market, the ADHD market, it's been remarkably resilient, healthy. There are not too many large CNS categories that have been growing at 8%, 9%, 10% on a unit basis for the last several years since the pandemic. Before that, it was more in the 3% to 5%, but since the pandemic, the growth has accelerated in that space. There is a lot of increase in mental health awareness and people willing to do something about it and stepping forward and seeking help. A lot of influencers talking about it and making it basically it's okay if you are going through a certain condition, it's okay to seek help, to acknowledge it, and so forth. All that has fueled some of that growth.
Now, if you look from a segment perspective, patient population perspective, the adult segment has been the fastest growing, given our history in ADHD, and we've watched it actually over the years. Pediatric segment was always fairly stable. It does grow in the 5%, maybe a little bit higher in high growth periods of time. It is very well diagnosed because a kid typically can get diagnosed at home, at school. There are a lot of different touchpoints that can observe the behavior of the kids and therefore try to seek help for the child, so to help them during the school years and so forth. Not so much on the adult side. A lot of adults that go through their life unnoticed, potentially they don't realize what they have. They do have their daily struggles. Things are overwhelming. Their life is chaotic. They can't focus on certain things.
They can't handle more than one task. You hear all these kind of issues, and adults then realize later on in life when their kid get diagnosed, they say, "Oh my God, I do the same things like my child. Maybe I should get myself checked out." That's how a lot of adults actually get diagnosed. Of course, with the increase in mental health awareness that I mentioned earlier, all that has been picking up. Therefore, the growth in the adult segment has been much higher. It also is reflected in our quarterly results, no less in the second quarter, we grew by 25% in the adult segment, and we grew by still very healthy 14% on the pediatric side. We have been able to take advantage of the growth in both segments, and we'll continue to do that.
Qelbree brings in a true value proposition for both patient populations. A little bit in a different way, not exactly the same for both because these patient populations have different needs, different issues, so to speak. For example, on the pediatric side, the obvious, a lot of parents don't want their kids on controlled substances. They don't want their kids on stimulants. If they can have an option which is a non-stimulant that really works, that would be their first choice. Why wouldn't it be, right? To give your child a chance not to be on controlled substances. Qelbree is that choice that we haven't had for a long time because we've had non-stimulants historically, but those non-stimulants, primarily like STRATTERA, you have to wait four, five, six, seven, even eight weeks into the school year, and you're hoping the drug will work.
Well, for me as a parent, that's like eternity. Every night I'm struggling with my kid trying to get through the homework, trying to get good grades. My kid is getting suspension letters, getting suspended from school, all these issues. If I'm going to go through all this for six, seven, eight weeks, that's like a nightmare. As a parent before Qelbree, I didn't have other choices. I will resort to a stimulant. That's why the market has been split up for a long time. 90% of the market is stimulants and only about 10% non-stimulant. Well, that has changed with Qelbree. Because with Qelbree, within a week, as early as week one, maybe week two for older children or adults, you will realize whether the drug is working or not.
You don't have to wait six, seven, eight weeks to find out whether the medication is the right medication for you. So now therefore, as a parent, I'll try it for a week, right? If that's going to give me the chance to avoid a stimulant, avoid a controlled substance, and have my kid on a non-stimulant, I'll do that every day. I'll make that decision. That's really the equation and the value proposition for parents is to give them that chance to be. Qelbree really works and works pretty well. On the adult side, you have a little bit different dynamics there. Adults typically like their stimulants, so they're not quick to get rid of the stimulant, so to speak. Although they do have side effects from them.
They don't love them through a lot of it, but they do like sometimes the feeling that they give them, the high, the happy feeling, the energy, whatever you want to call it. They characterize it differently, each person you talk to. But they also would like to be on something else because stimulants do have issues, whether they're cardiac, other side effects, and so forth. What typically happens there is a physician doesn't want to take the patient abruptly, completely off the stimulants very suddenly, because also sometimes you may have withdrawal symptoms. They will taper off the dose on the stimulant. Let's say you're on Adderall 50 mg, go down to 40, 30, 20, 10, over several weeks, while at the same time titrating Qelbree up with 100 mg - 200 mg, maybe to 400 mg, or even you can go as high as 600 mg for adults.
That's why, actually, when you look at our prescriptions in the adult population, about 40% of it is combination therapy. Eventually, the patient will taper off the stimulant and will stay on Qelbree, if that worked for them, obviously. In the end, they truly find that Qelbree is a true 24-hour product. Many of these stimulants that they have been using and they do use, although they are controlled, extended release products, maybe they last 12 hours, maybe 14 hours, some of them. A lot of times, you have to supplement with an immediate release later in the day because you have a long day, you still have to stay up, you have homework to do, you have presentation to prepare, study for a college exam or whatever. You don't have to do any of this with Qelbree.
Qelbree gives you the full control, full coverage for 24 hours, and that's really the beauty of the product and also works pretty well. The other factor, growth perspective, on the adult side, you also have the issue of comorbidities. A lot of patients have comorbidities, ADHD with depression, ADHD with anxiety, with a lot of other mood disorders. We did a phase IV study actually on Qelbree in that patient population, and we really saw pretty great results, not only in fixing the ADHD, but also addressing some of the other issues. We cannot promote, that's not data that is on our label, of course, but we have published the study because a lot of physicians had been asking us about why does Qelbree, in their practice, they've seen that it really elevates the mood, it really improves the mood for a lot of their patients.
Although it's meant only to fix attention, focus, and so forth. Now they understand it, and also we understand even more today the mechanism of action of viloxazine, which is the drug in Qelbree. It does have serotonin modulation. Clearly now you can connect the dots, with the serotonin activity, of course, and the drug over the years, for many years in Europe, it used to be an approved antidepressant. You have different dynamics within the different patient populations, but at the end of the day, you have a product here that really works for both populations, and we're seeing pretty healthy growth on both ends.
Can you talk a little bit about how large the adult opportunity can be? We have seen the growth in pediatric. You talked about the 25% growth in the adult population versus 14% pediatric. How large can the adult opportunity can be for Qelbree?
In total, as a brand, last year, we had about 935,000 prescriptions on Qelbree. The market is 111 million prescriptions. We are not even around 1% market share, basically, from a penetration. We have a long way to go here, a lot of room ahead of us as far as growth. On the adult side, the market itself, it splits up about 67%, 70% is adult, and the rest is pediatric. Qelbree is the reverse, exact opposite. 70% pediatric and 30% or 35%, depending which quarter you look at it, 35% adult. So we have a lot of room to grow on the adult side and also on the pediatric side because penetration-wise, we are still early in how far we can go. Based on the last quarter, pretty much we are annualizing, if you just take the last quarter, that is annualizing around $360 million brand so far.
We have got several years to go. Clearly, Qelbree can be a big product for us in that category.
Great. You talked a bit about the stimulant, non-stimulant market. There is some innovation that is coming around. I am specifically referring to the orexin agonists. There are some other new mechanisms that are being explored. How do you think about the category expanding, and how does that benefit in the expansion of this category?
We're always big proponents of innovation, new things coming in, competition. We view competition as a good thing. It really keeps you fresh, keeps you competitive. You're always looking to improve yourself and so forth. Competition is not necessarily always a bad thing. It can be a good thing. New mechanisms and new. If you look at ADHD, it's been really baffling that for so many years we only had two stimulants, amphetamines and methylphenidate. For decades, it's incredible that it's been so limited to a very few mechanism of action, so to speak. On the non-stimulant side, before Qelbree came in, again, you had only two major non-stimulants. This is a huge category that only had four molecules that really drove more than 90% of the business. Any new mechanisms, new products that could potentially do something different for these patients.
Not all patients respond to stimulants. Not all patients are going to respond to non-stimulants. So there is a lot of need out there for different things. Orexins, we'll see what happens from a data perspective. We're yet to see any data at this point in humans. So that remains to be seen. But we watch that category. We are committed to it, of course, ourselves as well. We do have, for example, a stimulant also in early stage development and will continue to be committed to the category.
Great. Switching gears a little bit, let's talk about your Parkinson's and movement disorder franchise. ONAPGO, you launched it in April last year. You did about $13.5 million in the quarter with 2,600 enrollment forms that you mentioned from about 720 prescribers to date. How's the launch tracking against your own expectations?
For this year, we updated the guidance in August recently by saying that we tightened the guidance $55 million-$70 million for ONAPGO. This is for 2026. In 2025, we did about $17 million, if I remember the exact number. So the launch has been going really good. We obviously did hit a snag with the supply constraint, but that's all behind us at this point. So we're pretty happy that in the second quarter we pretty much cleaned up the backlog that we had from the cases that have been piled up at the hub, at the specialty pharmacy from the supply constraint. So all that has been flushed through the system right now. So everybody now who is in the system, they are fresh, new forms. They are being processed under normal conditions, normal timing. The conversion is really even a little bit better than last quarter.
Things are really looking up pretty nicely on a steady state basis. Now we're very focused, of course, on building the demand, continue to build the demand, and bring in as many new forms and initiations of new patients as possible. We're pretty optimistic. The brand has done pretty well despite all the noise and the issues that we had to deal with. It's still a pretty good, successful launch for us.
You talked about tightening the guidance for that product. What does that franchise, the ONAPGO franchise, look like at scale for you? What does this dual supply that you've set up unlock operationally?
Yeah, from a supply point of view, even the current supplier actually is going to be able to continue to supply us in 2026 and also through 2027. We have also said we're lining up a second supplier as well behind that. We feel pretty good about the supply situation. It's pretty much behind us at this point. As far as how big this product is and at scale and so forth, we've put an estimate out there of $200 million - $300 million at peak. Yeah, maybe the $200 million is a little bit more on the conservative side. We'll see, getting another trend couple quarters, we'll see where it goes. The key premise, which I always try to explain to folks, is who is that patient? Who is the patient who's getting ONAPGO?
It makes a big difference on the peak demand and peak sales, whether it's an advanced patient and that's it, that's all we're getting, the progressed advanced patients who have been on levodopa carbidopa for a long time, and they hit a ceiling as far as to the benefit, incremental benefit they're getting from all these oral medications they're on. Now they are primed to get an apomorphine infusion device before they resort to deep brain stimulation or invasive surgery, right? Or is the patient a little bit more on the moderate side, and we're getting patients earlier in the disease, and therefore they're going to stay with us longer, and even the patient population is much bigger. That could change the estimate of the peak demand. This is a primary, a key critical question that we're trying to get a good feel for.
Now, given that we just recovered from the supply situation, we need a couple more data points to say, "Yes, that is the patient profile." Because right now we could take a snapshot, we could do surveys. But remember also, at a launch, physicians are experimenting as well with your product and trying to find who is the best patient for that product. In every product launch that happens, a physician, they're trying to figure out where does this product fit in within my practice. I may do a survey tomorrow and find out that they're using it on this profile, but three months from now, they may change that and figure out a different way of how they use ONAPGO, right?
We need few more data points to finally say and lock in and say, "It looks like this is really the patient profile that we're getting on ONAPGO, and that's how physicians are using it." Now, we do know in Europe, because the product had been available in Europe for many, many years, 20 + years, yes, the therapy does migrate eventually into more moderate earlier stage. That does happen over time, but that happened over a long period of time in Europe. So the question is, will it happen in the U.S., and how quickly will it happen?
Understood. There are other drugs in the Parkinson's and movement disorder franchise. We talked about ONAPGO, but you also have GOCOVRI, APOKYN, MYOBLOC. Help us understand the broader franchise and what excites you about the franchise that you have?
Yeah, we have actually even four products in this space. We have even a very small product, XADAGO, on top of all that, right?
That's right.
We have different products for different patient profiles and different needs. For example, early on when you get diagnosed, we all know most patients, pretty much all patients, get on levodopa carbidopa as their initial therapy. As time goes on, the disease progresses, you are getting more OFF episodes, you start increasing that dose of levodopa carbidopa, and you might add one or two other agents, oral adjunctive products in addition to levodopa carbidopa. XADAGO could be one of them, which is one of our products. As you keep increasing the levodopa carbidopa, you start hitting dyskinesia, and some people even get it even earlier, some get it later into the disease stage. That's where GOCOVRI comes into play. Our product, GOCOVRI, which is the only product approved for OFF episodes and treating dyskinesia.
That's where some physicians add GOCOVRI to the mix, to these other oral medications to address the dyskinesia as well as help also with the OFF episodes. Then as the disease progresses, some people start hitting or even earlier, people may need a quick fix, so to speak, because they are feeling the OFF episode coming on board. They are at a meeting, they are at an event, whatever. They can take an APOKYN injection. APOKYN injection, which is the apomorphine, can work literally within minutes. It's really rapid. It has a very robust efficacy. So that's where the APOKYN pen comes into the picture. Now, some patients over time end up taking maybe three, four, five injections of APOKYN, because they are really getting a lot of OFF episodes during the course of the day.
Those end up potentially also being candidates for our ONAPGO apomorphine infusion device. We pretty much have a solution, so to speak, across the different stages in the Parkinson's for different patients and different reads in the marketplace.
Wonderful. Switching gears a little bit, let's talk about your neuropsych part of the business, ZURZUVAE. This came to you with the Sage acquisition last year, and it's growing quite quickly. What we noted was the U.S. sales were up more than 50%, prescriptions were up 62% year-over-year. What have you learned about the postpartum depression market since you've taken it on?
Yeah. It's really been a great, exciting product. It's an incredible area, and it's amazing how underserved it is. You have pretty much about 500,000 women every year experiencing the symptoms of postpartum depression, and only 45% to 48% actually get diagnosed. Numbers are somewhere in the 60% to 70% of those who get diagnosed, get treated. Most of the treatments are SSRIs. These are products that were never designed, developed, approved, indicated, for postpartum depression. That's what physicians have used over the years because there is nothing else really developed for that indication. We all know what the issues with SSRIs are. You're shooting in the dark, so to speak, as far as the dose. What is the right dose for a specific patient? You're trying to titrate up. It could take you three weeks, four weeks, five weeks.
I don't know how long it will take for these SSRIs to kick in. On the other hand, you have ZURZUVAE that actually have been developed, indicated as the only product approved for postpartum depression today in the marketplace. It works, starts kicking in in day three, and you only take it for 14 days and you're done. That's a whole different versus the SSRIs that people are using that may or may not work. The worst thing you probably could do to a patient, to a mom and her family, is to make her wait several weeks and tell her, "You've got to go through whatever you're going through and continue to go through it, and we'll see whether this medication will work and when will it work." That is really horrible.
When you have another solution which could work quickly, by day three, it starts working, and then within 14 days you're done. A lot of physicians are finally understanding this value proposition and really what makes sense here for women. Because in the worst case, and we've seen cases in the news also about what could happen. In the worst case, this thing could progress into an ugly situation, unfortunately, for the baby, for the mom, for the whole family. So it's truly sad that we see still a lot of women suffering and going through that and not really getting that help that they need to get. Because of the low awareness of the disease among women, we have embarked this year on a DTC campaign with our partner Biogen, to improve the awareness. What is postpartum depression?
What are the things that you could be feeling? Whatever it is that you're feeling, this is not really your fault, because there is always a lot of shame or guilt that comes with these feelings. Because mom sometimes says, "What is it that I did wrong that I'm feeling this way? I shouldn't be feeling this way. I should be the happiest person on Earth with a newborn," right? "On the other hand, I have all these other feelings." It really takes a lot of education, and we're trying to help mom to say, "You're not alone. This is not something that you should blame yourself for. Step forward, talk about it to your physician about it, and so forth. Seek some help.
There is help out there that you can get benefit from." At the same time, we need to do very similar education on the healthcare provider side, because OBGYNs in general, they're trained to deliver babies and treat a lot of issues from a woman's health perspective. But not everybody is trained to treat psychiatric conditions, right? Many of them are not even comfortable diagnosing or treating postpartum depression. So we try to provide training and modules on what is it, how do you diagnose it? How do you look for it? If a patient approaches you, how do you discuss it with them, and how could you help them? Even if you're not comfortable helping them, at least refer them to somebody who can help them.
Because we can't just let them go and brush it off and ignore it, because that could develop into something that is really sad or difficult situation for everybody. So we're doing the education on both sides. It's more like market building at the same time when the product was launched, that we've been doing. I think this eventually is going to help us improve these diagnosis rates, improve the penetration and the number of patients we can serve. So far, the product has been on the market for about two and a half years, a little bit more. Probably we have served somewhere in the 30,000, 35,000 patients. That's it. Every year, you have 500,000 women who suffer and go through that condition. So we still have a long way to go. Last year, the product annualized around $200 million in total. Yeah.
So we've talked mostly about your commercial portfolio. In the last three minutes or so that we have, can you talk about the pipeline? There's a lot of innovation that's happening inside of Supernus. Can you talk about the pipeline and what excites you about the pipeline that you are working on?
Yeah, sure. In the pipeline, the two key lead assets. First one is SPN-820, which is a completely first-in-class novel antidepressant. SPN-817, which is also a novel mechanism for, not mechanism in general, but mechanism in the treatment of epilepsy. They both are very distinct in their profiles, differentiated versus the market and the competitive landscape out there. 820, very simply, the profile we are looking for and we are hoping to eventually get with the clinical data is this is an oral drug that can work within hours, and it has a ketamine-like effect, but without the hallucinations, the psychedelic type of effects, side effects, without the clinical observation that could be required for the safety of the patient, any of that. That you can take at home as a regular standard oral product.
If that actually ends up the profile of this product, this is a game changer in the depression market. Right now, what we have is a phase II-B study that is ongoing right now, placebo-controlled study in MDD. It is testing a different dosing regimen than the previous study we did, which is an intermittent 2,400 mg dose twice a week instead of a daily dose of 1,600 mg, which was the previous study we did. So we have a lot of solid evidence, data, that actually this is a target, the mTORC1 target, that you may not need to engage every single day with a daily dose. Not unlike psychedelics or ketamines, you do not get these injections every single day or these treatments.
There is a lot of CNS targets that you need to hit them once and let the system reset, and then you hit it two days later or what have you. We believe mTORC1 is one of those. Because we did an open label study and the results were amazing. Now, it is open label, of course, the big caveat, it is open label, but we saw a lot of signals across board. MADRS, HAM-D6, suicidality, all that where the drug intermittently, which is the same dose that we are testing right now in the current phase II-B study, giving us some really good results. So that is on the 820. SPN-817 is a potent seizure medication, but the key differentiation there, it is an acetylcholinesterase inhibitor, which are actually approved for Alzheimer's.
They have the potential of being pro-cognitive, and cognition or cognitive decline is a big problem in epilepsy. So we are hoping to have a product that can be potent from a seizure reduction perspective, but also helping patients with the cognitive issues that they suffer through.
Wonderful. Jack, thank you so much for your time up here.
Thank you.
It was great to learn about everything that's happening at Supernus and a lot of exciting stuff here. Thank you so much for coming and thank you for your time.
Thank you. Appreciate it.