Okay, thank you very much. Well, good afternoon, everyone. Thank you for joining us this afternoon. We're obviously excited for our next presentation. We're happy to present Supernus Pharmaceuticals here. For those of you who don't know me, I'll introduce myself. I'm Glen Santangelo. I'm the analyst at Barclays responsible for the specialty pharmaceutical sector, amongst some other things. You know, here joining us from Supernus today is the President and CEO, Jack A. Khattar, who you know, we're very happy to have you here, so thank you very much. Obviously a lot to talk about in 2025, you know, as you reposition yourself for 2026. Maybe, you know, that's a good place for us to start and sort of dig in.
You can talk about, you know, some of the accomplishments in 2025, in particular the Sage Therapeutics acquisition. In July, you had an FDA approval, new product launches. Let me let you start there and talk about how things have sort of evolved in 2025 and that set the stage for-
Yeah.
For 2026.
Yeah, sure. Thank you for having me. Just a quick reminder for everybody, I'll be making forward-looking statements, so please refer to our SEC filings for the risk factors. Yeah, I mean, 2025 was a remarkable year for us. Not only, you know, we pretty much completed the transition that we've been going through with the legacy products losing exclusivity, but also having a record year from a revenue perspective and numerous accomplishments, as you know, you mentioned. Starting with, of course, the Sage acquisitions and the addition of Zurzuvae to our product portfolio has been a tremendous addition to the portfolio. It's a major and will continue to be a major growth driver for the company. We're just getting started in that space. The product is only a couple of years old.
Of course, the approval and the launch of ONAPGO. That launch, and the performance of the launch pretty much surprised a lot of folks in a very positive way. We're very happy to add that product to our portfolio as well. Clearly the continued growth with Qelbree and Gocovri. If you look at our product portfolio, you know, 2025 pretty much marked a very important milestone for us. It's a complete makeover of our product portfolio with four growth drivers.
Right. When you think about those four growth drivers, right? Qelbree, Gocovri, Zurzuvae, and ONAPGO, I mean, they drove over 20% growth in the fourth quarter. Not that we wanna focus on the fourth quarter, but it felt like you were exiting the year with a fair amount of momentum, sort of setting the stage for 2026. Is there anything, you know, that you saw in the second half of 2025 that maybe surprised you know, positively or maybe anything that was, you know, maybe could have went a little bit better according to your expectations?
Oh, I mean, one of the big surprises in 2025 has been ONAPGO and the incredible performance of the product, you know, since we launched it back in April, to the point it actually contributed to a hiccup that we had on the supply side.
Right.
ONAPGO has been very exciting, its growth potential. The demand has been incredible. What also surprised us is, despite the supply constraint that we had, which we talked about in November, actually physicians, which is a great measure for demand, continued, you know, to submit forms, enrollment forms for patients despite the fact we had the hiccup. The forms grew from 1,300 forms to about 1,800 forms, you know, just in that period when we had these constraints. The demand continues to be strong. You know, we continue to be in front of these physicians, educating them about ONAPGO because we knew we're gonna come back at some point.
Now we're very excited that, you know, we have a good feel around that issue, a good, you know, plan in place for it, as we talked about it in February.
Wow. I mean, I think what you said that's important is despite the supply issue, the demand part of the equation was always there, and I think the market kind of recognized that, right? With the sort of reconfiguration of your portfolio in the second half of last year, I mean, the stock was up 80%, I think, in a six-month span. Clearly starting to get a lot of credit for that.
Yeah.
Congrats on.
Oh, thank you.
On those accomplishments. Why don't we dig into the four major products, the main products, and we'll start with Qelbree. Obviously, your biggest asset by a wide margin, this ADHD product for those that are less aware. The scripts were up big again in the fourth quarter, 18%, I think, highlighting that demand. You know, maybe can you elaborate a little bit here on what you think is driving the demand for that product, the competitive landscape around that product, and some of your commercialization efforts that may be driving that strong execution?
Yeah. I mean, right from the beginning, Qelbree has been fundamentally a very different product than what the market has been used to, historically. We've been in the ADHD market for, you know, 25 or 30+ years. We've created four different ADHD products historically, you know, starting with Adderall, Intuniv, Mydayis, and now Qelbree. We know the space very well, and for a long time we've been looking for a non-stimulant that actually works. That simple. A non-stimulant that really works. Specifically with the speed of onset, because the existing non-stimulants, specifically Strattera, for example, would take weeks and weeks, you know, for it to really kick in and for mom or the parents to really find out whether it's gonna work for their child or not.
If you can imagine a child in school struggling, whether it's grades, socially, suspension letters, all kind of difficulties throughout, I mean, five, six, seven, eight weeks into the school year is like eternity. What typically parents will resort to is go back to a stimulant because stimulants work quick, work fast, but they all have their issues. They are controlled substances, and not every parent wants to put their kid on a controlled substance.
Yep.
Today we have an option, which we didn't have that, and that is Qelbree because Qelbree works as early as week 1.
Hmm.
Specifically for children. You might need, as an adult, to titrate up for another week. Within two weeks for adults, you can tell whether it works or not. Why on earth would you put your child on a controlled substance if you have another option that within a week you can know whether it's gonna work for them or not? You can always resort to a stimulant, right? That has been a great value proposition for a lot of patients out there, whether on the pediatric side or even on the adult side. That's why we've seen, you know, great success with the product over the past five years.
As you rightfully pointed out, and even this past quarter, we grew by 18% for the year, by 21% in 2025, and that's already year five, and we're into year six.
Yeah.
And-
You're growing 18% five years in.
Yeah.
Can you talk about the physician education efforts and you think it's your commercialization efforts, you feel like help us assess sort of the durability of that trend, just sort of given your market share and your position in the market?
Yeah. I mean, market share in 2025, we did about 931,000 prescriptions. The market itself is 111 million prescriptions. We haven't even scratched the surface.
Yeah.
You know, as far as the potential out there. Clearly from an effort perspective, marketing effort perspective, I mean, the product is very well differentiated in the marketplace, and it's a very promotion-sensitive area.
Mm-hmm.
We continue to push through our sales force. The key, you know, recipe for success in this category, in any category, is very good targeting and, you know, frequency that you can get in front of these physicians to change habits. Because physicians are creatures of habits like we all are.
Yep.
You know? It takes time and frequency for us to convince them to start with a non-stimulant instead of always start with a stimulant. Because typically that's the first line of treatment, a stimulant, before they even, you know, consider anything else. We're trying to really reverse a lot of practices that have been established for years and years.
Yep.
You know, with a completely new paradigm here.
Okay. Can we maybe shift gears and go to Gocovri? You know, your second-biggest drug for extended release for Parkinson's, double-digit script demand as well here. You know, could you talk about the differentiation of this product and sort of your commercialization efforts here and sort of where you think we are in sort of that growth curve?
Yeah. I mean, Gocovri actually is the only product in the Parkinson's space that is approved for the treatment of OFF episodes and dyskinesia. Most of the products in Parkinson's, you know, treat OFF episodes, and that's it. Nothing really treats dyskinesia. Gocovri is the only product approved for that. It has a very unique positioning. Most people get dyskinesia at some point in the progress of, you know, during the progress of the disease. As they get more and more OFF episodes over time, they take different medications. Dyskinesia is caused by a lot of the medications that these patients are taking, and therefore, there is a great place for a product like Gocovri. Gocovri is now about nine years into the market.
Actually, it was launched back in 2017, and we were really excited to see last year growing at double digits, you know, 14% in prescriptions, 12%, you know, in net sales. We're very excited about the product and its continued potential. There is a lot of patients out there who could really use, you know, that type of product.
Yeah. Okay. All right. Let's shift gears. Let's go to Zurzuvae. You know, this is the asset you acquired from the Sage deal. You know, back us up and what attracted you to this asset in the first place?
Yeah. I mean, again, as you see from our portfolio, we're always looking for very unique products. Zurzuvae is the only product approved for postpartum depression at this point. It was the first and only oral treatment for postpartum depression. Until now and recently, most physicians, if they do actually diagnose and treat postpartum depression, they would use SSRIs. SSRIs haven't been really studied the right way or designed and developed, you know, for postpartum depression. Most of the times, they actually require the patients to wait for weeks for them to kick in. You know, they're not effective from day one. If you look at the Zurzuvae profile, by day three, you can start seeing impact on the disease, and you will be done by day 14. It's only a 14-day therapy, and you're done.
You rarely need any refills. You know, it doesn't come back as far as the condition itself. It's a very unique product. It's an asset that has longevity. It's a new chemical entity. It's really a great innovation in the space. We are in CNS and have been focused on CNS for years. That's why it was a very important asset for us to take a look at.
Any LOE concerns across the portfolio?
I mean, LOE is the most upcoming potential here will be Gocovri, which is like mid-2029. That will be the earliest one in the rest of the portfolio.
What about Qelbree?
Qelbree is 2035 is the last to expire there.
Okay. All right. I think in your opening remarks, you sort of talked about maybe ONAPGO as being maybe one of the positive surprises to you in 2025, how strong of a launch you had. Maybe you can just sort of talk about that first half of 2025 launch and sort of what you did in the second half that maybe sort of drove those strong results and that maybe faster uptake than maybe you expected.
Yeah, I mean, one of the key assumptions we had assumed initially because our label says advanced Parkinson's, you know, for the treatment of advanced Parkinson's. We assume that probably initially, at least initially for the first maybe couple of years, we're gonna get mainly severe patients who have progressed significantly in the disease. The only option for them at that time is either deep brain stimulation or, you know, another invasive surgery. Therefore, an infusion device would make a lot of sense for these patients, and those would be probably the most suited initially for the product. Now, the product itself had been in Europe for many years, and the clinical practice has shifted over the years to start treating actually more moderate, more earlier stage type of patients, but that happened over time. It didn't happen overnight.
That's why, you know, when we launched the product and we saw the demand, we're like, "Whoa." I mean, this is really much obviously stronger than we expected. We were starting to get to a point where we truly understand the patient profile and who is getting ONAPGO and who is on ONAPGO, and then, of course, we had the supply disruption. Before we know it, you know, we will have a much better handle on that patient profile. Most likely we maybe are getting, you know, patients who are more on the moderate side of it.
Yep.
That really opens up the whole opportunity.
Can you give us just a little bit of background on the supply disruptions that you disclosed in the fourth quarter? What drove those? What's the status of that? Sort of how we position, you know, relative to that for 2027.
Yeah. Currently, the product is produced by a third party, and it's not a production line that is dedicated to ONAPGO. There are other clients on that production line. Basically, what we face is that because of our overwhelming demand, and at the same time the other clients have also additional demands from a capacity perspective, you know, we couldn't get enough capacity and production from the third party. Through a lot of work and effort, so forth, we were able to finally, you know, fight for enough capacity for 2026, which we felt very comfortable with. That gives us-
With that supplier?
With that supplier. That will support our guidance that we gave in 2026, which is the $45 million-$70 million in sales on ONAPGO. In parallel, we're working with a second source of supply, and that is our own partner startup in Europe, who actually makes the same exact product for the European market. We'll be tapping into that facility. But that facility, you know, we have to make a submission. We have to get it registered by the FDA and approved, you know, for providing product into the U.S. market. We anticipate that second source of supply to come online in 2027. That's where we are, and that's why we felt comfortable that we can go back and start initiating patients.
Before we talk about the pipeline, let's just sort of wrap all that together when we talk about the guidance. Revenue is $840 million-$870 million. That's 32%-37% growth. That's. Those are big numbers across-
Yep.
The portfolio driven by those four products. I mean, anything sort of worth calling out within that top line number that maybe people would be interested or surprised to hear or?
No. I mean,
Will it be balanced growth across the portfolio?
You're gonna have balanced contributions from all these four products. I mean, that's the expectation that we have. I mean, Qelbree is gonna, it is our biggest product, but it's gonna continue to contribute very significantly.
Yep.
ONAPGO, of course, I mean, and we communicated what that is, $45 million-$70 million-
Yep.
on ONAPGO. Zurzuvae is gonna continue to grow significantly as well. It's only two years old as far as the product. I mean, we have treated only 20,000 patients. Every year, you have 500,000 women who suffer, you know, from postpartum depression.
Yeah.
There is a huge opportunity for us there. The contributions are gonna come from, you know.
The-
all the different pieces of the puzzle.
Despite that revenue growth, the operating earnings, $140 million-$170 million, roughly flat year-over-year. Could you put that in context for people-
Yeah.
given the revenue growth?
Yeah. I mean, given that ONAPGO and Zurzuvae are 2 years or less, I mean, they're still new. We're still investing behind them.
Yep.
Clearly, a lot of the marketing investments, I mean, we did communicate that on Zurzuvae, for example. We have a whole new program that didn't exist in 25, which is DTC campaign, to provide more education to women and mothers and expectant mothers and so forth. Because the knowledge and the awareness of postpartum depression is pretty low among consumers, and they don't really come forward and, you know, discuss these conditions with their doctor. A lot of the symptoms of postpartum depression are typically confused, unfortunately, with, you know, fatigue, lack of sleep, additional stress because when a newborn, you know, comes to the family, so to speak.
Yep.
Everything is disrupted. Schedules, fatigue, sleep, all that. People don't realize it actually could be postpartum depression. It's not necessarily just these kind of symptoms.
Sure.
It takes a lot of education, you know, to get women to realize that and mothers. To take the courage and take that first step and discuss that with their OBGYN because there is always also a lot of feelings of shame, guilt attached to that. You know, there is nothing to be ashamed of. These are normal things that could happen, and it's not your fault as a patient. That is due to the hormonal changes, you know, from pregnancy to delivery. This is something that does happen, and there is treatment for that.
Okay. What about the uptick in the R&D spending as well? Let's move over to the pipeline because you have 2 candidates in phase 2 and 1 candidate in phase 1. You know, I wanna give you a couple minutes to sort of talk about that pipeline and those three assets and kinda when we should expect the readouts on those 2 sort of phase 2 trials as those could be important catalysts one way or another for the stock.
Yeah. The two key programs are SPN-817, which is for epilepsy. We expect that product to be fairly differentiated from a potency efficacy perspective. As well, it has the potential to perhaps, you know, help with cognition because it's an acetylcholinesterase inhibitor, which is a very well-known class of drugs for memory.
Yep.
Alzheimer's, and so forth, so we expect that to be a differentiation for that product. It is currently, as you mentioned, enrolling phase two B. Now epilepsy trials tends to be notorious for being slow.
Yep.
Recruitment-wise, we're not expecting data till 2027.
Okay.
We just initiated recently the phase IIb on our SPN-820, which is a first-in-class New Chemical Entity in depression, and that's an MDD. Now MDD will probably recruit much faster clearly than the epilepsy program. Again, it will be in 2027. We'll be a little bit more specific as to when in 2027 as we get at least a quarter or two recruitment, so we can have a better trajectory on the completion of these studies.
Okay. Then you do have one product in phase 1, which is a stimulant used to treat ADHD. Could you talk about SPN-443? Obviously we're in the earlier stages, but you know, anything you wanna share related to this molecule or.
Yeah. I mean, it's still early, as you said.
Yep.
This year we're looking at starting the SAD and MAD study for this year. Last year we did the first in human, which gave us, you know, good tolerability and the safety profile of the molecule. We look towards this molecule to be a differentiated stimulant.
Yep.
you know, with the potency and efficacy of a stimulant, yet potentially not classified as a narcotic, you know, as a C2 kind of classification.
Yep.
It will be interesting to see the profile as we develop the product and what kind of a package we can come up with. It's a fairly differentiated molecule, and that's actually a molecule that came completely out of our own discovery program in R&D.
Elevated spending in 2026, you know, sort of keeps that operating profit roughly flat. I mean, I'm not asking you for sort of longer term guidance, but how should we think about the outlook for profitability sort of longer term and, you know, that pathway to sort of more operating leverage as some of your four commercial assets mature and we drive greater revenues and a lot of the physician education sorta begins to flat line or gets done or relative to the R&D spending. Paint us a multi-year picture of that operating profit.
Yeah.
sort of leverage, if you will.
There's no doubt. I mean, as time goes on, we will gain more operating leverage. You know, that's a given. We will get to even levels where we used to be at, you know, before loss of exclusivities and so forth, as we pass through some of these heavy investment years. I'll give you a very small example. On Qelbree, for example, we don't spend the same marketing budget we used to spend when we first launched the product or second line. I mean, you kind of taper off some of these investments as time goes on. We will expect to do the same thing and rationalize, you know, the spending and reallocate resources accordingly to the products and their growth profile. Certainly we will be able to leverage more the infrastructure that we have.
We're almost coming up on time, so I just have one last question. You know, when you think about sort of the transformation or evolution in 2025 in the portfolio and the developments that you made, the stock obviously benefited significantly in the second half of last year. Is there anything that you think, you know, may be still underappreciated, misunderstood, you know, with the investment community? Any consistent questions you're getting? Anything, you know, sort of worth calling out that you think, you know, could be a dislocation relative to what people think versus reality?
I mean, on the commercial side, I think people finally are getting there to, you know, where we, you know, thought we would be as far as the potential of our portfolio, you know, the growth assets and so forth. I think most people have a good appreciation for that. The pipeline certainly is still not appreciated, and I understand that because we need to generate more data on both, you know, SPN-817, SPN-820. I mean, should the science actually work and our thesis works on SPN-820, that will be another big transformation for Supernus. I mean, that product is a huge, huge product as far as differentiation in the depression market. I mean, that potentially could be an oral product. It is an oral product that could work within hours and has a ketamine-like effect without the hallucinations.
We have without any clinical supervision, without any of these, you know, baggage that you have with some of the other products being developed in that space. SPN-820 has a huge potential for really again, another transformation for Supernus moving forward.
Well, listen, Jack, we're out of time, but what I wanna do is I wanna flip it back to you to sort of give you the last word. I mean, we talked about a lot of the transformation here and a lot of the positives, but is there anything else that we didn't talk about that you wanna share with the investment community? Anything else that you think is important related to questions you're getting? I wanna give you the last word. Anything else you wanna leave.
Yeah, no.
With the investors here today?
Thank you for all your time. I mean, the only thing I would say is we're just starting. It's only the beginning and, you know, we have a clean balance sheet. M&A will continue to be also a key growth strategy for us. We're believers in both, you know, M&A as well as R&D, because science doesn't always work the way you like it to be, and M&A, you don't always find what you like to find.
Yeah.
You have to employ both strategies for continued future growth. Yeah.
Okay. Jack Khattar, President and CEO of Supernus Pharmaceuticals, thank you very much.
Thank you. Thanks.
Great to have you here.