Good afternoon, and welcome to Supernus Pharmaceuticals Fourth Quarter and Full Year 2024 Financial Results Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. Instructions will follow at that time. As a reminder, this conference call is being recorded. I would now like to turn the conference over to Peter Vozzo of ICR Healthcare, Investor Relations representative of Supernus Pharmaceutical. You may now begin.

Thank you, Jacinda. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' fourth quarter and full year 2024 financial results conference call. Today, after the close of the market, the company issued a press release announcing these results. On the call with me today are Supernus' Chief Executive Officer, Jack Khattar; and Chief Financial Officer, Tim Dec. Today's call is being made available via the Investor Relations section of the company's website at ir.supernus.com. During the course of this call, the management may make certain forward-looking statements regarding future events and the company's future performance. These forward-looking statements reflect Supernus' current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the Risk Factors section of the company's latest SEC filings. Actual results may differ materially from those projected in these forward-looking statements. For the benefit of those of you who may be listening to the replay, this call is being held and recorded on February 25, 2025. Since then, the company may have made additional announcements related to the topics discussed. Please reference to company's most recent press releases and current filings with the SEC. Supernus declines any obligation to update these forward-looking statements, except as required by applicable securities laws. I'll now turn the call over to Jack.

Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us on today's call. Our 2024 results reflect solid commercial execution across the company, including continued growth of our core products and strong growth in operating earnings. Our performance in 2024 underscored our emphasis on growing our core business despite the loss of exclusivity on both Trokendi XR and Oxtellar XR. Total revenues excluding Trokendi XR and Oxtellar XR increased by 25% for the full year 2024. Driving this growth was Qelbree's robust performance with 25% growth in annual prescriptions as reported by IQVIA and 72% growth in annual net sales. In the fourth quarter of 2024, prescriptions reached another all-time quarterly high of 214,600 prescriptions. In 2024, Qelbree's annual prescription growth outpaced that of the ADHD market that grew by 9%, reaching 103 million prescriptions. Qelbree's back-to-school momentum carried through the fourth quarter with sequential prescription growth of 11% compared to the third quarter. This prescription growth enabled Qelbree to have a strong fourth quarter with net sales reaching $74 million representing a 60% increase over the fourth quarter of 2023. In 2025, Qelbree is off to a good start with exciting news about the FDA approval of its updated label. The new label further elaborates and differentiates Qelbree's mechanism of action as a novel nonstimulant, reinforcing its multimodal pharmacodynamic profile and highlighting its unique partial agonist activity at the serotonin five HT2C receptor and inhibition of the norepinephrine transport. Also the label is now updated with new and important lactation data for breastfeeding women with ADHD. Such information is crucial for the important and growing adult female patient segment. In addition, earlier this month at the annual national psychopharmacology update conference, Supernus presented interim results from an open label Phase IV trial with Qelbree…

Thank you, Jack. Good afternoon, everyone. As I review our fourth quarter and full year 2024 results, please refer to today's press release and 10-K was filed earlier today. Total revenue for the fourth quarter of 2024 was $174.2 million compared to $164.3 million in the same quarter last year. Total revenue in the fourth quarter of 2024 was comprised of net product sales of $166.4 million and royalty, licensing and other revenues of $7.8 million. The increase in net product sales was primarily due to the increase in net product sales of our core products, Qelbree and GOCOVRI. Excluding net product sales of Trokendi XR and Oxtellar XR, total revenues for the fourth quarter of 2024 increased 29% compared to the same quarter of last year. For the fourth quarter of 2024, combined R&D and SG&A expenses were $108.1 million as compared to $104.6 million for the same quarter last year. Operating earnings on a GAAP basis for the fourth quarter of 2024 were $21.4 million as compared to an operating loss of $1 million for the same quarter last year. Recall during the fourth quarter of 2023, we booked a $20.2 million intangible asset impairment charge, reflecting the forthcoming loss of exclusivity of XADAGO in December of 2027. GAAP net earnings was $15.3 million for the fourth quarter of 2024 or $0.27 per diluted share, compared to GAAP net earnings of $1.2 million or $0.02 per diluted share in the same quarter last year. On a non-GAAP basis, which excludes amortization of intangibles, share based compensation, contingent consideration, impairment charges and depreciation, adjusted operating earnings for the fourth quarter of 2024 was $48.3 million compared to $47.1 million in the same quarter of last year. Total revenues for the full year 2024 were $661.8 million compared to $607.5…

Thank you. [Operator Instructions] Our first question comes from Andrew Tsai at Jefferies. Your line is open.

Hey, thanks for taking my questions. Good afternoon. Congrats on the nice quarter. A couple of questions to start. If we backed out other products from your 2025 revenue guidance with reasonable assumptions, is it fair to infer maybe you're thinking Qelbree this year could do maybe somewhere around $2.65 to $2.95 Is that a fair range or are you thinking something different? And then secondly, what do you think are the key levers to sales growth this year? Is it more TRx or is it more price or is it both? Thank you.

Yes. Hi, Andrew. Regarding the range, it is a fair range. We try not to give guidance by product, but you could back into something like this. As far as the key levers for this year, there's certainly continued prescription growth. As we've seen and we've been very pleased with the performance of the product. As I mentioned in my prepared remarks, Q4 carried a lot of the momentum from the back-to-school season and set us up in a very nice way to start in a nice place for 2025. So we're certainly looking forward for more prescription growth. The market grew by 9%. We grew by 25% last year, and we still have a long way to go here. As I mentioned, the market is now at 103 million prescriptions a year. We're only at 767,000 prescriptions in 2024. So we still have a lot of penetration that we can accomplish clearly with the product. And the basics of the product are still very, very solid. What I'm referring to is really satisfaction by patients. The very important segment, for example, adult segment, the patient satisfaction is very high. It's around 80%. To give you a little bit of reference, it's only 53% for Strattera. And to have, you know, a very nice high satisfaction rate for a non-stimulant in the adult population, that's really pretty strong. We all know adults love their stimulants. So for a non-stimulant to have that level of satisfaction. So we're very encouraged by a lot of the metrics behind the product, and therefore, looking forward to another hopefully strong year on Qelbree.

Great. And then as we think about your pipeline after, SPN-820's TRD data, how does your BD appetite change now, if at all? And can you remind us the latest and greatest on how much firepower you have now? Thank you.

Yes. From a pipeline perspective, I mean, the first thing is just to clarify, 820 is not terminated. Otherwise, we would have said that in the press release. So that remains to be seen and we'll see what the next steps will be and certainly we'll communicate that as far as to what decisions we make. But aside from that, our BD activities will continue to be top priority at the company, looking for -- from a priority perspective, first, commercial products, if we can bring in more revenue generating products. And then next priority would be things that are more in the mid stage to late-stage pipeline assets. And then from a therapeutic perspective, we're agnostic of whether it's psychiatry or neurology. We're pretty flexible there. And we're even open to other therapeutic areas as I may have mentioned in the past and certain remarks that we've actually participated in certain processes and looking at assets outside CNS as long as the situation involves multiple assets, not just one asset in a whole new therapeutic areas. But if there is some scale, there is multiple assets, we would be interested in also expanding beyond just CNS. So it is a top priority. And as Tim mentioned earlier, we do have significant flexibility clearly given that our balance sheet is fairly clean. We have no debt. We have a strong cash position that we continue to add to. As far as the size per se, it really depends on the situation itself. I mean, you could go really big if a certain situation brings in its own cash flows that will help us and will support leveraging situation. So that in total could range from $500 million to $1 billion, $1.5 billion I mean, depending on the situation and the cash generation by the target that we're looking at.

Thanks so much. Appreciate it.

Our next question comes from Stacy Ku at TD Cowen.

Thanks so much for taking our questions and congratulations on the progress. First question is on Calvary. That performance in Q4, can you just walk through the variables driving strong pricing, especially as kind of 2025 just help us understand what you're thinking about gross-to-net this year? And then a second follow-up on Qelbree. Can you just talk about how the adult launch is progressing? And then, second question is on SPN-820. Are you able to kind of give some idea of the timing of your strategic conclusions? Do you plan to make a decision this year? And then for the third question, for the ONAPGO launch, how should we think about the trajectory? What needs to be done to be ready? And are there any sales expectations embedded into 2025 guidance? Thanks so much.

Yes. I'll try to take them in the same order. So on Qelbree, we had certainly a very strong quarter in the fourth quarter, as I mentioned. A big portion of that is clearly the prescription growth. So we grew by 11% sequentially. As far as the gross to net, it really, as related to the pricing portion of that question, it really didn't change much. So the gross-to-net on Qelbree has been fairly stable now in the last three quarters, on the lower side of the range. So that's now will it change in 2025? Absolutely. I mean, clearly Q1 is always as we always know in this business in general, Qelbree or no Qelbree across all the industry. Q1 will be worse from a gross-to-net perspective because of the increase in the co pay costs as we improve the benefits to help patients through the deductibles and so forth. So for the full year of 2025, probably the gross-to-net is going to be more in the 50% to 55%. That will be my guess at this point. And that's the same range we had talked about that in November of last year when we talked about the gross to net. Regarding the second question you have on the adult launch, I mean, we're pretty pleased, as I referred earlier, as far as performance of the product with adults, our efforts in the adult segment, across male and female patient populations. The product continues to perform really well. We do see more combination type of use in the adult patient population, meaning physicians are adding Qelbree to the existing stimulant that adults are on. And over time, they tend to reduce the stimulant dose and increase the Qelbree dose. With the ultimate goal, of course, is to take the…

If I could, just quickly follow-up. What share are you at for the adult segment right now in ADHD for Qelbree with the split?

Share of Qelbree of the total ADHD market. We're closing in on…

Sorry. I apologize. The flip, which is of the Qelbree launches -- of the Qelbree prescriptions, what percentage is adult right now 2024.

Yeah. Adult is in the 30% to 32%, it bounces around quarter or depending on the seasonality. So, but it's basically the reverse of how the market splits. If you remember, the market is about 33% pediatric and 67% adult. So we still have a lot of room where we can grow in the adult side.

Understood. And I apologize. And now for SPN-820 and timing?

Yeah. Sure. So moving on SPN-820, regarding the timing of what the next steps would be, we sure hope to do that in the next couple of months. I don't know, could we do it earlier? We'll see. But certainly, it wouldn't be this year, as related to your question, and we'll do it as early as we can. We do think potentially we know what could be behind the results. We have looked at cross studies. We looked at different sub analyses, patient populations, different things. We couldn't see anything really that sticks out that have resulted with the result that we issued. But theoretically, there is a good reason to believe that potentially the dosing regimen is what's behind the different results that we got in the placebo-controlled study versus the open label study. So we will be digging deeper into that aspect of it and see from a biologic perspective what the rationale is. There is a theory out there that maybe you don't need to hit the mTORC1 system frequently every single day. And actually intermittent dosing is needed or required for the system to function very well and to regulate depressive symptoms. So and therefore, intermittent dosing is probably more suitable than frequent every single day type of dosing, which was the case in the Phase IIb study. So much more to be investigated at this point. We'll continue to analyze the data and we'll come back and communicate that as soon as possible. And then I believe the last question was regarding ONAPGO, if I heard it right?

Yes. That's correct.

Yeah. So could you go ahead and repeat the question if you don't mind?

Yes. So just help us understand the trajectory of the launch, what needs to be done to be ready and if there are any sales expectations embedded into guidance.

Okay. Yes, sure. Yes, the trajectory of the launch, I mean, we've said all along, it will probably be a slow build. Now, however, having said that, we also know that a lot of KOLs have been waiting for this product and we may have a bolus of patients who may come in at the beginning and then it will start going back to a more normal slower rate. So that all that remains to be seen. That is a possibility out there, but it remains to be seen. As far as our guidance, to be even more specific, I mean, we don't have really a lot in the guidance for ONAPGO. It's really single digit number, mid to a little bit high single digit. So it's not really much as far as this year's guidance.

Thank you so much.

Our next question comes from Annabel Samimy of Stifel.

Hi. This is Jack on for Annabel. Thanks for taking our questions. So now that you have ONAPGO approved with the label specifically for severe patients, do you have a better sense of what your market will be and who might the low hanging fruit be for an apomorphine pump versus a levodopa/carbidopa pump? And could you remind us again how all of your PD products now fit together? Do you expect the pump to partially cannibalize the opportunity for Apokyn at all? And, where does GOCOVRI fit in with the rest?

Yes, sure. The label for ONAPGO says advance of Parkinson's disease. And as you would probably expect, I mean, the definition of advanced by a lot of KOLs might vary between, you know, what they consider advanced. For some KOLs, advanced maybe could mean that I have a patient been diagnosed now 10 years ago. They've tried a lot of agents out there, a lot of the oral adjunctive therapy with levodopa/carbidopa and they're getting to a point where maybe they need deep brain stimulation or some other invasive surgery product and so forth. And that could be a candidate, and would be a candidate for ONAPGO. Another KOL might say, you know what, I've had a patient who's only been diagnosed three or four years ago, but really struggling with all the oral agents out there and therefore I might want to try the pump. So all this remains to be seen clearly. Everything we do promotional and everything, will be centered around the advanced patients. And, as far as the interaction or the overlap, if you want to say, between ONAPGO and potentially Apokyn, just to clarify, ONAPGO is really providing you with all day continuous infusion of apomorphine and it is for all day control. However, Apokyn is more for acute episodes -- single injection for acute episodes. So there is a very distinct positioning clearly and uses for these two products. Now we have said in the past that potentially there might be some overlap or some cannibalization of Apokyn. In case you have patients, for example, who might be taking multiple injections of Apokyn during a certain day, they may choose to try the pump. I mean, there is a possibility, but clearly from our perspective, the two products are separate. Apokyn indication as for…

Great. Thank you.

Our next question comes from David Amsellem of Piper Sandler.

Thanks. Just a couple for me. So, first on ADHD and Qelbree specifically, how are you thinking about the competitive landscape to the extent that others non stimulants enter the market? We're going to get a data readout for solriamfetol in adult patients, for instance, in the not too distant future. So how are you thinking about competitive landscape, not just in terms of volumes, but how that might impact the payer landscapes and your gross to nets going forward? So that's number one. And then number two, sorry if I missed this, but have you announced pricing for ONAPGO? And if you haven't, can you tell us where you think it could be just as a point of reference relative to AbbVie's VYALEV? Thanks.

Yes. Regarding ADHD and the competitive landscape, it's really very hard for us to make any comments at this point until we see the labels of or even first before labels, the data from these products. So we really don't have and haven't seen any Phase III. So that remains to be seen as far as whether these products will be competitive actually, versus Qelbree and so forth. So that remains to be seen on both products, the two products that are out there and currently in development. And whether that will impact the payer landscape or not, we tend to be very disciplined as you guys know when it comes to payers. So we will do what we believe is right for Qelbree. We know that Qelbree brings an incredible differentiation in the marketplace. We have a significant head start clearly in the non-stimulant, and it has been the first novel nonstimulant in decades introduced in this category. And we've been able to have a very good payout strategy across four, and we're very pleased with the coverage that the product has today and in the foreseeable future. Finally, on the price of ONAPGO, it is public at this point. I mean, we priced it within a very, I think, good range clearly that is competitive in the marketplace. That's all I can say on that.

Okay. Thanks.

Our next question comes from Kristen Kluska at Cantor Fitzgerald.

Hi, everyone. Congrats on a great quarter. Given you've been following the ADHD patients for a while, can you comment on roughly what percent of them do you believe have comorbidities that are potentially on two plus drugs to address both the ADHD and other conditions? And how you're now thinking about penetrating more into that space now that the FDA has acknowledged this in your label, although I know you've been, believing in this and talking about the data and have had anecdotes from physicians in the past.

Yes. ADHD is very well known, and that to have significant comorbidities, across board. A lot of it are mood disorders such as depression, anxiety, even bipolar and so forth. As far as the percentages, they do range from we've seen numbers from the as many as 40% to even 60% of ADHD patients that have a lot of these comorbidities. They do tend to be an issue for a lot of patients out there because actually stimulants are kind of contraindicated for a lot of these mood disorders because they tend to exacerbate these issues. And that's why, a lot of the adults or some of the adults are on nonstimulants, so for that reason. We are certainly, as I mentioned in my prepared remarks, we're certainly pleased with the fact that it is now acknowledged that viloxazine is very different than atomoxetine. It does have a very unique mechanism of action. It is a multimodal pharmacodynamic activity that happens with viloxazine, specifically on the serotonin. And that's really what has separated the molecule for actually years or decades from the data that had failed actually in clinical trials in treating certain mood disorders. Now that is something we cannot promote. We will not promote and we will not talk about any other indications for Qelbree other than what's on the label clearly. But it was a very important scientific information that physicians have been looking for since actually the day we've been developing, the Qelbree because they have seen certain things in the clinical studies and they would like to know clearly around the serotonin because they do use other products that also did have serotonin activity. And we need to inform physicians about that because they worry about serotonin syndrome and all kinds of things from safety perspective. So we're very pleased to see that change in the label to better inform physicians on the activity of the drug in general. And clearly, we are very also encouraged by the open-label study that I talked about, which is an ADHD and comorbid disorders, mood disorders. So we encourage folks, to look at the publication of the poster at the conference in May.

Okay. Thank you for that. And then on the BD front, can you talk about, you know, I know you had some comments on it before, but just therapeutic areas and spaces that you think are really promising and you can kind of leverage some of your in-house capabilities that you've been working on in the past?

Yeah. I mean, we look for areas that are I mean, they don't have to be necessarily adjacent to CNS or synergistic with CNS. They could be on their won as long as that situation as some scale to it. So we wouldn’t be as interested in something completely new with only one product. Because then it puts more pressure try to look in build that one product and find other products or product candidates, pipeline assets, that can help you build that scale in this new therapeutic area. So preference would be, if we were to enter a new area, hopefully from day one, we could find something that could be a multi-asset situation, whether that's commercial pipeline and mix of both, that will allow us to bring in the scale and the efficiency and the operation from R&D all the way into commercial execution. So that is how we think about it and it doesn't really matter whether I'm just going to throw out examples. It doesn't mean that's what we're looking at, but whether it's dermatology, ophthalmology, urology, any of these specialty areas where we can be very efficient and effective, with a reasonable small sales force effort behind it. In addition to that, we have a really good infrastructure to deal with the rare disease and orphan diseases. We are very well set up, especially, for example, in the Parkinson area, where we have very strong infrastructure to support rare orphan diseases. So those would be also areas that we would be interested in.

Thank you, Jack.

Thank you.

I'm showing no further questions at this time. I would now like to turn it back to Jack for closing remarks.

Thank you. In concluding our call this afternoon, we thank you for joining us to learn about our strong operating performance in the fourth quarter and full year 2024. The company has executed well through a multiyear transition and the loss of exclusivity on two of its legacy products. Excluding our legacy products, Trokendi XR and Oxtellar XR, we continue to deliver robust double-digit growth in revenues. The company continued to generate also strong cash flows behind the strength of its portfolio, particularly its core products and to the efficiency of its operations. As a result, and as we mentioned earlier, we finished the year in a position of financial strength with $454 million of cash on the balance sheet at no debt. We believe we are well positioned for continued growth beyond the current transition and are focused on several key areas. First, driving growth and generating strong cash flow from our core products, particularly Qelbree, allowing us to continue our investments in our pipeline. Second, the launch of ONAPGO in the second quarter of this year. And third, advancing our innovative R&D portfolio of differentiated first in class molecules. Finally, corporate development will continue to be a top priority to augment our growth to external opportunities. Thanks again for joining us this afternoon. We look forward to updating you on our next call.

Thank you for your participation in today's conference. [Operator Closing Remarks].