Good afternoon, and welcome to Supernus Pharmaceuticals Fourth Quarter and Full Year 2025 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to hand the conference over to Peter Vozzo of ICR Healthcare, Investor Relations representative for Supernus Pharmaceuticals. You may now begin.

Thank you, Antoine. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals Fourth Quarter and Full Year 2025 Financial Results Conference Call. Today, after the close of 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. This call is being made available via the Investor Relations section of the company's website at www.ir.supernus.com. During the course of this call, 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 24, 2026. Since then, the company may have made additional announcements related to the topics discussed. Please reference the 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. Supernus had a remarkable 2025 with significant progress made against our strategic objectives. The company achieved record total revenues of $719 million, delivered strong growth of 40% in revenues from our 4 growth products, successfully executed an integrated acquisition of Sage Therapeutics, obtained the FDA approval of ONAPGO and launched ONAPGO in the Parkinson's market. Our financial performance in 2025 once again underscored our emphasis on growing our core business despite the loss of exclusivity on both Trokendi XR and Oxtellar XR. With our 4 growth products, Qelbree, GOCOVRI, ZURZUVAE and ONAPGO, we have built a solid foundation for a new phase of accelerated growth for Supernus. During the fourth quarter of 2025, revenues from these 4 growth products accounted for approximately 76% of total revenues. Starting with ONAPGO, during the fourth quarter of 2025, ONAPGO generated net sales of $8.9 million, up from $6.8 million in the third quarter of 2025, and finished its first year on the market with $17.3 million in total net sales. Demand for the product continues to be healthy despite the announced supply constraints with more than 540 prescribers submitting over 1,800 enrollment forms since the launch of the product and through the end of January 2026. We have been focused on resolving the supply constraints that we discussed on our third quarter 2025 earnings call. Progress with the current supplier has been made, allowing us to resume new patient initiation while continuing to service our existing ONAPGO patients with maintenance therapy. Our current outreach effort of verifying health benefits and coverage includes more than 700 patients whose forms are currently in the queue for processing. In the fourth quarter of 2025, prescriptions grew by 29.6% and the number of prescribers grew by 28% compared to the third quarter of 2025.…

Thank you, Jack. Good afternoon, everyone. As I review our fourth quarter and full year 2025 results, please refer to today's press release that was filed earlier today. We achieved record total revenue of $211.6 million for the fourth quarter of 2025, an increase of 21% compared to the same quarter last year. Excluding net product sales of Trokendi XR and Oxtellar XR, total revenue for the fourth quarter of 2025 increased 34% compared to the same quarter last year. Total revenue in the fourth quarter of 2025 was comprised of net product sales of $158.1 million, collaboration revenues associated with ZURZUVAE of $32.8 million, and royalty, licensing and other revenues of $20.7 million. This includes $15 million of licensing revenue recognized in the fourth quarter of 2025 related to the achievement of a regulatory milestone under our collaboration agreement with Shionogi. Please note, collaboration revenues represent approximately 50% of the sales of ZURZUVAE reported by Biogen. This increase was primarily due to the increase in net product sales of our growth products, Qelbree and GOCOVRI, as well as the addition of collaboration revenues from ZURZUVAE, and from the launch of ONAPGO in April of 2025. For the fourth quarter of 2025, combined R&D and SG&A expenses were $150.2 million as compared to $108.1 million for the same quarter last year. Operating loss on a GAAP basis for the fourth quarter of 2025 was $4 million as compared to operating earnings of $21.4 million for the same quarter last year. The change was primarily due to higher Sage operating costs in the fourth quarter of 2025, and incremental intangible asset amortization for ZURZUVAE and ONAPGO. GAAP net loss was $4.1 million for the fourth quarter of 2025 or a loss of $0.07 per diluted share compared to GAAP net earnings…

[Operator Instructions] Our first question comes from Andrew Tsai from Jefferies.

This is John Cox on behalf of Andrew Tsai. Congrats on the quarter. So -- just so we understand the current supplier can supply $45 million to $70 million of sales. And to get to that $70 million, can that be done by the current supplier? Or does the high end require you to lock in the second supplier, say, like earlier than 2027?

Yes. For the current supplier, they'll be able to -- the plan is to get us supplied through 2026. So certainly, that will cover us for the guidance that we gave, the $45 million to $70 million. And then we expect the second supplier to provide us product in 2027. Now regardless of when in 2027, the second supplier comes in, the current supplier will be there for us to be able to bridge to the second supplier. So the plan is that we will have continuity of supply between the 2 suppliers with the current one covering 2026, maybe a little bit in 2027, depending on when the new supplier comes online.

Okay. And then maybe one more, if I can, on ONAPGO. To get to that second supplier, what kind of data, assuming nonclinical would ultimately be needed to obtain FDA approval. Is that kind of the ultimate gating factor here?

Yes. Typically, you'll have to produce some batches at the new site or new supplier. You produce some stability data, key basic data, you put a package together, submit it to the FDA. And on an average, I mean, it could be 6 months review, 9 months review. We will get more clarity fairly soon in the next month or so. And then based on that, we will expect the approval, hopefully. So that's typically the time line and the kind of package. So the answer is yes, there will be no clinical study or data that you need to provide.

Our next question comes from David Amsellem from Piper Sandler.

So 2 for me. First on ONAPGO, and I apologize if I missed this. I just want to clarify. So with the additional capacity, how much of underlying demand can you meet? Or maybe ask another way, can you fully clear the backlog, if you will, with the additional capacity that you now have in place? So that's number one. And then secondly, regarding the R&D organization with the integration of Sage, you mentioned you're taking on some early-stage products. And just wondering out loud, how you're thinking about prioritizing those, especially relative to your legacy pipeline assets and when we might get some updates on what you're going to bring forward into the clinic there?

Yes. Regarding ONAPGO, the current supplier will certainly help us clear the backlog through the continuous supply that we will be able to have throughout 2026 and more than just the backlog, of course, and because we are initiating new patients, not just with the current situation, meaning the 1,800 forms or 700 patients in the process, of course, that number will continue to be refilled during the year as we continue to grow the number of forms and so forth. So we expect the current supplier to be able not only to clear the backlog, but also, of course, continue to provide for whatever needs we have throughout 2026 until we get the second supplier online. As far as the Sage R&D programs and so forth, I mean, these are really early-stage assets. So -- for now, we will be doing some early preclinical work, things like this to verify the activity, the mechanism of action, the selection of an indication and so forth. So there will be a lot of preclinical type of work that has to be done on these assets. So as far as prioritizing them within the portfolio that we have, we look at every product separately on its own merits from a timing perspective, market opportunity, ROI and so forth. So I mean, they will go through the same process of prioritization from a portfolio perspective.

Okay. And if I may just sneak in a follow-up. Does that mean with the early-stage assets you have and with your mid-stage assets in the pipeline, your BD focus is really more focused on market-ready and commercial stage assets. Is that a good way to think about it?

Yes, that is correct. We are focused on revenue-generating situations, products on the market and potentially late-stage pipeline assets. So products that are in the pipeline that are at a later stage than our own pipeline. So they can get us to the marketplace or give us some other product launches, somewhere between '27 and '30, '31 time frame, that will be something that will be ideal for us.

Our next question comes from Stacy Ku from TD Cowen.

Congratulations on an earnings update and the ONAPGO supply update. So first, just as we think about the ONAPGO guidance for the year and the patient demand that clearly all the analysts are trying to triangulate around. Maybe first, could you talk about the learnings on the patient profile since launch? Maybe talk about the frequency of use that you're seeing. What we're trying to understand -- better understand, obviously, there's going to be a range, but how should we be thinking about the potential net pricing for a year of treatment? So that's the first question. And then when it comes to the resumption of the new patient initiations for ONAPGO, should we be thinking about that 1,800 enrollment forms is reflecting a more limited writing from clinicians despite the supply disruption? Just a bit of a point of clarification for our second question. And then the third, as we're just, again, trying to understand the enrollment forms, as the sales force is going back to the clinicians and patients, what kind of dynamics are you seeing in terms of ONAPGO demand and switches [indiscernible]. Our understanding is that behind the scenes with commercial reimbursement and infrastructure was kind of continuing even though we didn't know whether there's going to be supply or not. Happy to clarify the first question.

Hopefully, I'll get all of them. I'll start with the first one. As far as the profile of the patient, I mean, these are folks that are advanced in the disease. A lot of the oral medications are not enough anymore. So they continue to have certainly a lot of episodes during the day. And they're not really well controlled with levodopa/carbidopa and with any of the other adjunctive oral therapy that they're taking. And therefore, they would be -- and in the physician's mind, they would be good candidates for subcutaneous continuous infusion for something that is different than levodopa/carbidopa, if that is the case, and that's what the physician is looking for. And therefore, they would choose something like ONAPGO, apomorphine as a molecule, as a drug for that patient. As far as the potential moving forward and where the net pricing is going to land, I mean, clearly, the product has been on the market a fairly short period of time, only 8 months or 9 months. Certainly, that will, over time, will calibrate depending on what we end up doing, if we do any contracting and so forth. But we talked historically about -- on an average, it's probably $105,000, $100,000 per year on a WAC basis per patient. Now that certainly assumes a certain usage, which we are starting to get a better feel for. I don't have the data as much as I would like to before I say that's exactly how people are using the product and how frequently they're using it. But the $100,000 typically assumes about a cartridge a day, give or take, to get to that price or cost per year -- per patient. And then the next question, I believe, was basically on the 1,800 forms and so forth.…

No, no, that's understood. I think we were hoping to hear whether or not more of these enrollment forms were being processed for reimbursement while waiting for the supply to be replenished. But understood. Just one quick follow-up to your answer on the first net pricing piece then. What kind of gross net would you have expected for a specialty product?

For a product -- I mean, we've been in this space, I mean, typically, it ranges somewhere between 20% and 30% depending on the quarter, right? Because Q1 is typically on the higher end and then it decreases over time, and then the cycle starts again. I mean that's typically the range, 20% to 30%. If I were to guess, it's a pure guess at this point based on our experience in the category.

Got it. And then last, if you may, if we could sneak one in on Qelbree. Just the Q1 dynamics in light of the normal seasonality and maybe some of the onetime impacts this winter, just curious how you all are thinking about the following quarter for Qelbree?

Seasonality on Qelbree?

Correct, for Q1.

I mean Q1, typically, it's not a seasonality because of school or anything. Typically, it's your typical seasonality from an insurance point of view. And that's not just Qelbree and all products in general because of the high deductibles that patients are facing. So I mean, for the last couple of years, I think we were more like flattish from a prescription or maybe went up a little bit. So I mean it's going to fluctuate. I'm not saying that's exactly what will happen this quarter. But I mean you get some pressure. Now we also calibrate some of the co-pay business rules so we can help patients as much as possible in Q1. We typically do that to offset some of that pressure. So sometimes, we're pretty successful and actually prescriptions do grow nicely in Q1. So we'll see where we land, but nothing really unusual, I guess, I'd have to say versus previous years.

Our next question comes from Kristen Kluska from Cantor Fitzgerald.

Jack and Tim, congrats on a great quarter of revenues and progress here. On ONAPGO and the second supplier, I wanted to ask if you can provide a little bit more color about the profile of the supplier. So for instance, if we see in 2027, 2028 that demand is continuing to outpace how you're thinking about it internally? Are they going to be the type of supplier that can be flexible and add more capacity for your product? How important has that component been in your decision-making when it comes to who's going to be best to supply this product?

Yes. The second supplier is actually our own partner in Europe. So they have their own manufacturing facility, and that's the same facility that produces product for the European market. So it's exactly the same product. And obviously, they have significant experience in making the product. Capacity-wise, they have significant capacity, much larger capacity than the current supplier. And we're also -- I mean, have discussions with the third supplier. So I mean, our plans, obviously, is we're going to secure the supply for the long term. This is not a just 1-year situation. We want to make sure that should the demand be as large as everybody is expecting, clearly, we will have enough supply to meet that demand. So that's really the plan that we have in place and we are executing on. And that's why we feel pretty confident to the extent we can, obviously, that 2027, we should be really good for the second supplier and even beyond that.

Okay. And you had mentioned earlier that you'll have more clarity in a month or so. Is that just on what you'll exactly need to show in terms of more process runs or any comparability -- stability data, excuse me, that you need to conduct prior to getting that approved on board. Is that my understanding?

Yes. I mean in the next month or so, we will be having more communication with the FDA. So we will have more clarity what are the different pieces. Again, the product is exactly the same product as is in the U.S., European and U.S. There are some differences in like specifications and things like this. But from a production point of view, it's exactly the same product. So we feel pretty good. But again, until we have that discussion, it will be difficult for us to know the exact timing and the extent of the package itself.

Okay. And then at what point during this cycle are you going to be comfortable enough telling physicians, hey, we're going to have more supply in X months from now, so you can kind of get patients towards this therapy again. I know you've talked about the fact that this community has been really supportive of you for the fact that you've worked hard for these patients. You've had 4 drugs approved for this community. So I'm just trying to understand at what point they can kind of give the patients the green light that you don't have to wait much longer a solution is coming.

I mean that, in a way, it's now happening, meaning we have already communicated to physicians that we are back to normal, so to speak. We will be processing forms. We will be initiating new patients. We will be sending shipments to patients. So we want them to continue to submit forms as they had. I mean it was really remarkable the support we got it from the physician community. Last time we talked we had 1,300 forms, even despite the supply constraint, we were up to 1,800, as I mentioned in my prepared remarks. So the physicians continue to think of ONAPGO as a really -- real treatment for a lot of the patients, and they're with us, and they'll continue to serve their patients. So we're pretty much at normal. Now I can't say normal, normal because we have to work through the backlog. So I mean, things don't happen like overnight where overnight, you're going to initiate another 700 patients, right? So it's going to be over time that given the capacity we have, you have to think about nurses, initiations, all that. So we will be able to provide a little bit more update later on by May, clearly. But as far as keeping the demand and being able to serve our patients, we are in that position right now.

Our next question comes from Pavan Patel from BoA.

Jack and Tim, so first, congrats on the supply constraint resolution. I think this is a best case scenario. So really happy with you and the patients. I know our own survey work has shown that the demand for this product is really strong among both movement disorder specialists and patients. So my first question is, as you work through initiating these 700 patients out of the queue, should we expect a temporary drag on ONAPGO's gross to net in the first half of 2026? And will a significant portion of these patients require bridge supply or quick start programs while their benefits are being verified? And then I guess just like a modeling question, can we do more than $70 million with the supply that your current supplier is able to offer you, assuming that state and the second supplier are not online in 2026? And then just maybe one on ZURZUVAE since I think that's a topic worth hitting as well. I think the 70% repeat prescriber rate is pretty strong. So maybe as you plan your commercial efforts in 2026, are you shifting your focus towards driving deeper penetration volume among those existing repeat prescribers? Or is the priority going to be start -- start being to expand the absolute number of OB/GYNs and psychiatrists writing their first prescription?

Yes. Maybe I'll start with the last question. On ZURZUVAE, clearly, I mean, we are still -- and the way we think about it, we are still launching the product. That's the mindset we always have with new products, clearly, always launching. And as we mentioned earlier, this is a market that hasn't been really prepared a lot before the product was launched because the initial indication was supposed to be MDD instead of PPD. So basically, the product was launched and the market is being built at the same time. So we still have a lot of work to do in building the market, education-wise. The brand actually enjoys a very, very high awareness, but we need to turn that awareness into action. We need to turn that awareness into confidence by physicians and to have the courage to actually screen, diagnose and treat PPD. So we will continue a lot of the great programs that Biogen and Sage had actually had started way back when they launched the product and into 2025. We will continue a lot of these type of programs into 2026. And actually, this year in 2026, and some people may have already seen the commercial, we have DTC efforts as well to educate as well the consumer and make more and more women and mothers comfortable in talking about their condition and come forward and seek treatment because there is treatment and they can really feel much better after taking a product that is only a 14-day treatment and not waiting too long for it to actually kick in only within day 3. So a lot of activity behind ZURZUVAE because we're only scratching the surface at this point as far as the potential of this product. I mean, launch to date, we treated…

And then just on the gross to net in the first half of '26, do you think that...

I'm sorry...

ONAPGO...

Yes. I mean for ONAPGO on the gross to net, as I mentioned earlier, I mean, it's probably going to be somewhere in the 20% to 30% again, higher in Q1 typically and lower as the year goes on because typically, Q1, you're going to have more incentives and things that will pressure the gross to net.

Our next question comes from Annabel Samimy from Stifel.

This is Jack on for Annabel. Congrats again on the quarter. Just quickly on the -- for the CNS pipeline products for 817 and 820, do you have anything you can give us on the pace of enrollment there for either trial and when we might be expecting top line data? And then on BD, are there any particular areas of focus you're looking at for new products? I know you've mentioned previously possibly broadening scope outside of CNS, potentially expanding into other areas like in women's health now that you have ZURZUVAE. Have those priorities changed at all? And are you looking more at stand-alone specialty commercial products or small portfolios of assets?

Yes. Regarding the CNS, the pipeline on 817 and 820, I mean, 820, we just basically initiated the trial. So that's still early as far as enrollment. But you would expect an MDD trial to recruit much quicker than typically an epilepsy trial. So for 820 and 817, both trials, we're looking at data sometime in 2027. It's not going to be this year. Hopefully, as time goes on, we'll have a much better trajectory, specifically on 817 because epilepsy trials tend to be much slower from a recruitment point of view. And also, these are multicenter trials, specifically the one in 817, which is also geographically extends beyond the U.S. So typically, those are also -- could potentially be slower. So -- but data is not going to be any time before 2027. As time goes on, maybe in May or August this year, we'll be able to give you a better feel, is it first half, second half, first quarter, fourth quarter, whatever, we'll update folks as time goes on. As far as BD, absolutely. I mean, our focus has been CNS will continue to be CNS, and we're agnostic, whether that's neurology or psychiatry. And yes, we did say historically that we are willing to go outside CNS. And obviously, the Sage acquisition in a way, overlapped on both. It is a CNS product, but it got us into women's health. So clearly, that's an area we are looking at right now. And our priorities will continue to be revenue-generating, cash flow generating opportunities. And if there are any assets there that are pipeline assets, our preference would be more on later-stage assets. Again, that could potentially give us new product launches in the '27 to 2030, 2031 time frame. So that's really the prioritization that we have and what we're working towards from that perspective. And as Tim said, we have a nice clean balance sheet. So we have flexibility on whether the transaction is a product, is it a company? Is it a portfolio of products? So I mean that gives us some flexibility there, obviously.

This concludes the question-and-answer session. I will now turn it back to Jack Khattar for closing remarks.

Thank you for joining us on this call today. 2025 was a special year for Supernus. It marked our 20th year anniversary and the completion of our successful transition from our legacy products, Trokendi XR and Oxtellar XR. In 2025, Supernus delivered one of its best performances ever with record revenues of $719 million behind the robust performance of its growth portfolio consisting of Qelbree, GOCOVRI, ZURZUVAE and ONAPGO. Supernus has now a diversified portfolio of growth products where our future success is not solely dependent on one single product. We expect to see continued healthy growth from Qelbree and GOCOVRI, augmented by significant growth from ZURZUVAE and ONAPGO, 2 products that have been on the market for 2 years or less and have a significant market opportunity. In addition to our 4 growth products, we continue to advance our pipeline and to explore corporate development opportunities to position Supernus as a long-term growth company while generating at the same time, strong cash flows behind the strength of our expanded product portfolio and through the efficiency of our operations. Thanks again for joining us this afternoon. We look forward to providing you with updates throughout the year.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.