Supernus Pharmaceuticals - Q4 2025

Transcript

Operator (participant)

Good afternoon. Welcome to Supernus Pharmaceuticals for the quarter and full year 2025 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 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 just begin.

Peter Vozzo (Managing Director)

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 factor 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 24th, 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. Now to the call over to Jack.

Jack A. Khattar (President and CEO)

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 four 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 four growth products, Qelbree, Proquarius, 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 four 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 for 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. Switching now to Zurzuvae, the brand had strong performance in 2025, with $32.8 million in collaboration revenues in the fourth quarter and $53 million for the 5-month period since the closing of the Sage acquisition on July 31, 2025. Full fourth quarter of 2025, U.S. sales of Zurzuvae, as reported by Biogen, increased approximately 187% compared to the same period in 2024 and approximately 19% compared to the third quarter of 2025.

The number of prescribers in 2025 doubled compared to 2024, with more than 70% being repeat prescribers. Total prescriptions in 2025 increased by more than 150% compared to 2024. Regarding Qelbree, the product had another year of robust performance, with 21% growth in total annual prescriptions in 2025 compared to 2024, and as reported by IQVIA. Qelbree exceeded $300 million in net sales for the year 2025, delivering 26% growth compared to 2024. In 2025, the brand delivered double-digit prescription growth of 29% and 18% in both the adult and pediatric patient populations, respectively.

For the fourth quarter of 2025, total prescriptions increased by 18% compared to the same period in 2024, while net sales increased by 9%, as net sales were impacted by an annual gross-to-net deduction. This was due to an unexpected bill of $4 million received from one of the PBMs covering the full year of 2025, and which was fully reflected in the fourth quarter. For full year 2025, gross-to-net for Qelbree ended up at approximately 49%. Our expectation for 2026 continues to be consistent with our previously disclosed target of 50%-55%. Switching now to GOCOVRI.

For full year 2025, net sales reached $146 million, increasing by 12% compared to 2024. Total annual prescriptions reached an all-time high of approximately 67,000, growing by 14% compared to 2024. The brand finished 2025 with strong prescription growth of 16% in the fourth quarter compared to the same period last year, with net sales of $38.6 million. Moving on to R&D, we initiated a follow-on Phase IIb randomized, double-blind, placebo-controlled trial with SPN-820 in approximately 200 adults with major depressive disorder. This study will examine the safety and tolerability of SPN-820 and its efficacy at a dose of 2,400 milligrams, given intermittently twice per week as an adjunctive treatment to the current baseline antidepressant therapy.

Our Phase IIb randomized, double-blind, placebo-controlled study of SPN-817 is ongoing, with a targeted enrollment of approximately 258 adult patients with treatment-resistant focal seizures. This trial utilizes 3 milligram and 4 milligram twice daily doses. For our SPN-443 program, we expect to initiate a Phase I, single ascending and multiple ascending dose study in adult healthy volunteers in the second half of this year. We have completed our evaluation of the early-stage pipeline assets from the Sage acquisition. As a result, we will retain certain assets for internal development, we will be seeking partnerships for the remaining assets. Finally, corporate development will continue to be a top priority for us as we look for additional strategic opportunities to further strengthen our future growth and leadership position in CNS through revenue-generating products or late-stage pipeline product candidates.

With that, I will now turn the call over to Tim.

Tim Dec (CFO)

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 products 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 of $15.3 million, or $0.27 per diluted share in the same quarter last year. On a non-GAAP basis, which excludes amortization intangibles, share-based compensation, contingent consideration, depreciation, and acquisition-related costs, adjusted operating earnings for the fourth quarter of 2025 was $48.5 million, compared to $48.3 million in the same quarter of last year.

Total revenues for the full year 2025 were a record $719 million, excluding net product sales of Trokendi XR and Oxtellar XR. Total revenue for the full year 2025 increased 27% compared to last year. Total revenues were comprised of net product sales of $626.6 million, Zurzuvae-related collaboration revenues of $53 million, and royalty and licensing and other revenues of $39.4 million, including the aforementioned $15 million of licensing revenue received due to a regulatory milestone. During 2025, collaboration revenues represented sales reported by Sparx since the close of the Sage acquisition on July 31st, 2025. Combined R&D and SG&A expenses for the 12 months ended December 31st, 2025, were $591.8 million, as compared to $430.4 million last year.

The change was primarily due to higher SG&A expenses, including approximately $73 million of acquisition-related costs from the Sage acquisitions and approximately $50 million relating to Sage operating costs recorded since the closing of the acquisition. Operating loss on a GAAP basis for the full year 2025 was $62.3 million, as compared to operating earnings of $81.7 million for 2024. GAAP net loss was $38.6 million for the full year 2025, or a loss of $0.68 per diluted share, compared to a GAAP net earnings of $73.9 million or $1.32 per diluted share in 2024.

On a GAAP basis, which again excludes amortization intangibles, share-based compensation, contingent consideration, depreciation, and acquisition-related costs, adjusted operating earnings were $158.7 million, compared to $183.7 million for last year. As of December 31, 2025, the company had approximately $309 million in cash equivalents, and marketable securities, compared to $454 million as of December 31, 2024. The decrease in our cash was primarily due to the funding of the Sage acquisition, offset by cash generated from operations. The company's balance sheet remains strong, with no debt and significant financial flexibility for potential M&A and other growth opportunities. Turning to 2026 guidance.

For full year 2026, we expect total revenues to range from $840 million-$870 million, comprised of net product sales, Zurzuvae collaboration revenues, and royalty and licensing revenues. Note, total revenue guidance for full year 2026 assumes approximately $45 million-$70 million of net sales from ONAPGO. As Jack mentioned, new patient initiation for ONAPGO began in the first quarter of this year. For the full year 2026, we expect combined R&D and SG&A expenses to range from $620 million-$650 million. Overall, we expect full year 2025 operating, and operating income loss in the range of breakeven to a loss of $30 million. Finally, we expect non-GAAP operating earnings to range from $140 million-$170 million.

Please refer to the earnings press release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non-GAAP. With that, I will now turn the call back to the operator for Q&A. Operator?

Operator (participant)

Thank you. At this time, we will conduct a question-and-answer session. To ask a question, you will need to press star 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 again. Please stand by while I compile the Q&A roster. Our first question comes from Andrew Tsai from Jefferies. Please go ahead.

Jon Cox (Analyst)

Hey, guys. This is Jon Cox on behalf of Andrew Tsai. Congrats on the quarter, thanks for taking my question. Just so we understand, the current supplier can supply $45 million-$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?

Jack A. Khattar (President and CEO)

Yeah, for the current supplier, the plan is to get us supplied through 2026. Certainly that will cover us for the guidance that we gave, you know, the $45 million-$70 million. 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, you know, to the second supplier. The plan is that we would have continuity of supply between the two suppliers, with the current one covering 2026, maybe a little bit in 2027, depending on when the new supplier comes online.

Jon Cox (Analyst)

Okay, thanks. Maybe one more, if I can, on ONAPGO. To get to that second supplier, what kind of data, assuming non-clinical, would ultimately be needed to obtain FDA approval? Is that kind of the ultimate gating factor here? Thanks.

Jack A. Khattar (President and CEO)

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

Jon Cox (Analyst)

Great. Thanks so much. Congrats again.

Operator (participant)

Thank you. Our next question comes from David Amsellem, from Piper Sandler. Please go ahead.

David Amsellem (Managing Director and Senior Research Analyst)

Thanks. Two for me. First, on ONAPGO, and I apologize if I missed this. I just wanna clarify. 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? That's number one. 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, you know, 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 gonna bring forward into the clinic there. Thank you.

Jack A. Khattar (President and CEO)

Yeah. Regarding ONAPGO, the current supplier will certainly help us clear the backlog, you know, through the continuous supply that we will be able to have throughout 2026, and more than just the backlog, of course. Because we are initiating new patients, and 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. 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, you know, the second supplier online.

As far as the Sage R&D programs and so forth, I mean, these are really early-stage assets, for now, we will be doing some, you know, early preclinical work, things like this, you know, to verify, you know, the activity, the mechanism of action, the selection of an indication and so forth. There will be a lot of preclinical type of work that has to be done on these assets. As far as prioritizing them within, you know, the portfolio that we have, we look at every product separately on its own merits, from a timing perspective, market opportunity, you know, ROI, and so forth. I mean, they will go through the same process of prioritization from a portfolio perspective.

David Amsellem (Managing Director and Senior Research Analyst)

Okay, thanks. 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?

Jack A. Khattar (President and CEO)

Yeah, that is correct. We are focused on revenue-generating, you know, situations, products on the market, and potentially late-stage pipeline assets. 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, you know, between 27 and 30-31 timeframe. You know, that would be something that would be ideal for us.

David Amsellem (Managing Director and Senior Research Analyst)

All right. Thank you, Jack.

Operator (participant)

Thank you. Our next question comes from Stacy Ku, from TD Cowen. Please go ahead.

Stacy Ku (Analyst)

Hey there. Thanks so much for taking our questions. Congratulations on an earnings update and the ONAPGO supply update. 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 gonna be a range, but how should we be thinking about the potential net pricing for a year of treatment? That's the first question.

When it comes to the resumption of the new patient initiations for ONAPGO, should we be thinking about that 1,800 enrollment forms as reflecting a more limited writing from clinicians despite the supply disruption? Just a bit of a point of clarification for our second question. 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 logistics availability? Our understanding is that the behind the scenes, the commercial reimbursement and infrastructure was kind of continuing, even though we didn't know whether there's gonna be supply or not. Happy to clarify the next question. Thanks.

Jack A. Khattar (President and CEO)

Hey, hopefully I'll get all of them. The first one, as far as the, you know, 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. Therefore, you know, they would be, and in the physician's mind, they would be good candidates for the subcutaneous continuous, you know, 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, you know, for that patient. As far as the potential, you know, moving forward and where the net pricing is gonna land, I mean, clearly the product has been on the market fairly short period of time, you know, only eight months or nine months. Certainly that will, over time, you know, will calibrate depending on what we end up doing, if we do any contracting and so forth. We thought historically about, you know, on an average, it's probably $100,000 per year on a WAC basis, you know, per patient.

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, you know, say, you know, that's exactly how people are using the product and how frequently they're using it. The 100,000 typically assumes about a cartridge a day, you know, give or take, you know, to get to that price or cost per year or per patient. Then the next question, I believe, was basically on the 1,800 forms and so forth. If I really understood the question, I mean, think about it, that's like a funnel, that's like a bucket of all the demand. That's why we try to give you this number, to give you an idea of what the demand is.

Clearly, as we process these forms, as eventually as patients get the shipments eventually, you know, you're gonna lose some forms or some patients on the way. I mean, that's typical in any process, or any specialty type of product. Typically, that's what happens. You could lose certain patients in the process for many different reasons, as whether it's incomplete information, you can never finish the form or complete it. You'll be surprised sometimes how many phone calls you have to make, whether to the patient or to the doctor's office, to even complete the form so that you can start processing it. When the hub starts processing the form, and then doing the adjudication for insurance reimbursement, you could lose some patients there.

As time goes on, a patient may change their mind or their situation might change, medical situation. For all these factors, clearly, you know, the 1,800 don't necessarily end up being 1,800 patients at the end of the day. I don't know. What was it? I don't know if there is another question after that.

Stacy Ku (Analyst)

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 we're waiting for the supply to be replenished. Understood. Just one quick follow-up to your answer on the first net pricing piece, then. What kind of gross nets would you have expected for a specialty product?

Jack A. Khattar (President and CEO)

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

Stacy Ku (Analyst)

Got it. Last, if you, 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 one-time impacts, I was wondering, just curious, how you all are thinking about the following quarter for Qelbree?

Jack A. Khattar (President and CEO)

The seasonality on Qelbree?

Stacy Ku (Analyst)

Correct, for Q1.

Jack A. Khattar (President and CEO)

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. That's not just Qelbree, I mean, all products in general, because of the high deductibles that patients are facing. 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. I mean, it's gonna fluctuate. I'm not saying that's exactly what will happen this quarter, I mean, you get some pressure. Now, we also calibrate some of the co-pay business rules, we can help patients as much as possible in Q1. We typically do that to offset some of that pressure.

Sometimes we're pretty successful, and actually, prescriptions do grow nicely in Q1. We'll see where we land, but nothing really unusual, I guess I'd have to say, versus previous years.

Stacy Ku (Analyst)

Okay. Incredibly helpful. Thank you so much.

Operator (participant)

Thank you. Our next question comes from Kristen Kluska, from Cantor Fitzgerald. Please go ahead.

Kristen Kluska (Analyst)

Hi, Jack and Tim. Congrats on a great quarter of revenues and progress here. On SPN-820 and the second supplier, I wanted to ask if you can provide a little bit more color about the profile of the supplier. For instance, if we see in 2027, 2028, that demand is continuing to outpace how you're thinking about it internally, are they gonna be the type of supplier that can be flexible and add more capacity for your product? You know, how important has that component been in your decision-making when it comes to who's gonna be best to supply this product?

Jack A. Khattar (President and CEO)

Yeah, the second supplier is actually our own partner in Europe. They have their own manufacturing facility, and that's the same facility that produces product for the European market. 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. We're also, I mean, have discussions with a third supplier. I mean, our plans, obviously, is we're gonna secure the supply for the long term. This is not a just 1-year situation. We wanna make sure that should the demand be as large as everybody is expecting, clearly we will have enough supply to meet that demand.

That's really the plan that we have in place, and we are executing on, and that's why we feel pretty confident, you know, to the extent we can, obviously, that the 2027, we should be really good with the second supplier and even beyond that.

Kristen Kluska (Analyst)

Okay, thanks. 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 or stability data, excuse me, that you need to conduct prior to getting that approved on board? Is that my understanding?

Jack A. Khattar (President and CEO)

I mean, in the next month or so, we will be having more communication with the FDA, so we'll 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. 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.

Kristen Kluska (Analyst)

Okay. At what point during this cycle are you gonna be comfortable enough telling physicians, "Hey, we're gonna have more supply in X months from now, so you can, 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 four drugs approved for this community. I'm just trying to understand at what point they can kinda give the patients the green light, that you don't have to wait much longer, a solution's coming.

Jack A. Khattar (President and CEO)

I mean, that in a way, it's now happening. Meaning, you know, 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. We want them to continue to, you know, submit forms as they have. I mean, it was really remarkable the support we gotten from the physician community. Last time we thought we had 1,300 forms, even despite the supply constraint, we were up to 1,800, you know, as I mentioned in my prepared remarks.

The physicians continued to think of ONAPGO as a really real treatment for a lot of the patients, and they're with us, and, you know, they'll continue to, you know, serve their patients. We're pretty much at normal. Now, I can't say normal, because we have to work through the backlog. I mean, you know, things don't happen, like, overnight, where overnight you're gonna initiate another 700 patients, right? It's gonna be over time that, given the capacity we have, you know, you have to think about nurses, initiations, all that. We will be able to provide, you know, a little bit more update later on, you know, by May, clearly. As far as keeping the demand and being able to serve our patients, we are in that position right now.

Kristen Kluska (Analyst)

Thanks, Jack. Glad to hear these are coming together.

Operator (participant)

Thank you. Our next question comes from Pavan Patel from BofA. Please go ahead.

Pavan Patel (Biopharma Equity Research Analyst)

Hey, Jack and Tim. First, congrats on the supply constraint resolution. I think this is a best-case scenario, so really happy for both 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. 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 nets in the first half of 2026? Will a significant portion of these patients require bridge supply or quick start programs while their benefits are being verified?

A modeling question, can you do more than $70 million with the supply that your current supplier is able to offer you, assuming that STADA and the second supplier are not online in 2026? One on Zurzuvae, since I think that's a topic worth hitting as well. I think the 70% repeat prescriber rate is strong. 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 gonna be to expand the absolute number of OBGYNs and psychiatrists writing their first prescription? Thank you.

Jack A. Khattar (President and CEO)

Maybe I'll start with the last question. On Zurzuvae, clearly, I mean, and the way we think about it, we are still launching the product, you know? That's the mindset we always have with new products. Clearly, you're always launching, as we mentioned earlier, I mean, this is a market that hasn't really prepared a lot before the product was launched, because the initial indication was supposed to be MDD instead of PPD. Basically, the product was launched, the market is being built at the same time. We still have a lot of work to do in building the market, education-wise. The brand actually enjoys a very, very high awareness, we need to turn that awareness into action.

We need to turn that awareness into confidence for, by physicians, and to have the courage to actually screen, diagnose, and treat PPD. We will continue a lot of the great programs, you know, that Biogen and Sage have actually, you know, have started way back when they launched the product and into 2025. We'll continue a lot of these type of programs into 2026. 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, you know, 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 within, only within day 3. 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 around 20,000+ patients. That's it. As some of you probably recall, you know, every year you have 500,000 women who actually experience symptoms of PPD, and only about half of them get diagnosed, and then 60%-70% of those are treated. There is a lot of people there who need help and where Zurzuvae can really help them pretty well.

As far as current prescribers or new prescribers, I mean, like every other product, when it's still early in the launch, you're certainly getting a lot of new prescribers, clearly, you know, from a reach perspective, and also as time goes on, you can have more frequency on these physicians. Those prescribers who are current prescribers, actually, the data shows us that 70% of the prescribers are repeat writers. We are getting a lot of business from the current prescribers. That speaks for, of course, also the high satisfaction level with the product and how it's performing.

You know, once the physician actually takes that first step and has the confidence, the conviction, and the courage to diagnose and treat, once they see the result from the first patient, they tend to be repeat writers, that's really very encouraging, you know, for the product at this stage. Moving on to ONAPGO. I mean, could we do more than $70 million? That is always potential, you know. I mean, that is also could happen. I don't know right now, everything we have today, all the information we have as far as demand and everything, you know, got us to the point where we believe the range is really $45 million-$70 million. Could it be that we could go above $70 million? I truly don't know right now.

Otherwise, we would have had a higher end if we had, you know, comfort that we could go above that. We feel pretty good right now where we stand on ONAPGO and the supply situation, and that's so the guidance that we gave is really to help folks to see where the goalposts are on both ends.

Pavan Patel (Biopharma Equity Research Analyst)

Thanks, Jack. Just on the gross nets in the first half of 2026, do you think?

Jack A. Khattar (President and CEO)

I'm sorry, on what?

Pavan Patel (Biopharma Equity Research Analyst)

Gross nets.

Jack A. Khattar (President and CEO)

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

Pavan Patel (Biopharma Equity Research Analyst)

Thank you.

Jack A. Khattar (President and CEO)

Thank you.

Operator (participant)

Thank you. Our next question comes from Annabel Samimy from Stifel. Please go ahead.

Speaker 9

Hi, this is Jack on for Annabel. Thanks for taking our questions, and 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? 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? Are you looking more at standalone specialty commercial products or small portfolios of assets?

Jack A. Khattar (President and CEO)

Yeah. Regarding the CNS, you know, the pipeline on SPN-817 and SPN-820, I mean, SPN-820, we just basically initiated the trial, so that's still early as far as enrollment. You would expect an MDD trial to recruit much quicker than typically an epilepsy trial. For SPN-820 and SPN-817, both trials, we're looking at data sometime in 2027. It's not gonna be this year. Hopefully, as time goes on, we'll have a much better trajectory, specifically on SPN-817, because epilepsy trials tend to be much slower from a recruitment point of view. Also, you know, these are multi-center trials, specifically the one in eight one seven, which is also geographically extends beyond the U.S. Typically, those are also, you know, could potentially be slower.

But data is not gonna be any time before, you know, 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, you know, 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, we continue to be CNS, and we're agnostic, whether that's neurology or psychiatry. Yes, we did say historically that we are willing to go outside CNS, and obviously, the Sage acquisition, in a way, you know, 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.

Our priorities will continue to be revenue-generating, cash flow-generating opportunities. 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 the new product launches in the, you know, 2027 to 2030, 2031 timeframe. That's really the prioritization that we have and what we're working towards from that perspective. As Tim said, you know, we have a nice clean balance sheet, so we have flexibility on whether, you know, the transaction is a product, is it a company, is it a portfolio of products? I mean, that gives us some flexibility there, obviously.

Speaker 9

Great. Thanks so much.

Operator (participant)

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

Jack A. Khattar (President and CEO)

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 to Qelbree 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.

Operator (participant)

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