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SUPERNUS PHARMACEUTICALS, INC. (SUPN) Q4 2025 Earnings Call Transcript

41 segments

Prepared remarks

OperatorOperator

Good afternoon, and welcome to Supernus Pharmaceuticals Fourth Quarter and Full Year 2025 Financial Results Conference Call. 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.

Peter VozzoInvestor Relations

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.

Jack KhattarCEO

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, 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 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 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. 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 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 approximately 49%. Our expectation for 2026 continues to be consistent with our previously disclosed target of 50% to 55%. Switching now to GOCOVRI. For full year 2025, net sales reached $146 million, increasing by 12% compared to 2024, and 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 and 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, and 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.

Timothy DecCFO

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 of $15.3 million or $0.27 per diluted share in the same quarter last year. On a non-GAAP basis, which excludes amortization of 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 Supernus since the close of the Sage acquisition on July 31, 2025. Combined R&D and SG&A expenses for the 12 months ended December 31, 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 related to the 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 GAAP net earnings of $73.9 million or $1.32 per diluted share in 2024. On a GAAP non basis, which again excludes amortization of 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, 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.

Now turning to 2026 guidance. For full year 2026, we expect total revenues to range from $840 million to $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 to $70 million of net sales from ONAPGO. As Jack mentioned, new patient initiation for ONAPGO begins 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 to $650 million. Overall, we expect full year 2026 operating income loss in the range of breakeven to a loss of $30 million. And finally, we expect non-GAAP operating earnings to range from $140 million to $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.

Questions and answers

OperatorOperator

Our first question comes from Andrew Tsai from Jefferies.

John CoxAnalyst

This is John Cox speaking on behalf of Andrew Tsai. Congratulations on the quarter. We need to clarify that the current supplier can provide between $45 million and $70 million in sales. To reach the $70 million figure, can this be achieved with the current supplier, or will the higher end require securing a second supplier before 2027?

Jack KhattarCEO

Yes. The current supplier will be able to supply us through 2026, which will definitely meet our guidance of $45 million to $70 million. We expect the second supplier to provide product starting in 2027. Regardless of when in 2027 the second supplier comes on board, the current supplier will be there to help transition to the new supplier. Our plan is to ensure a continuous supply between the two suppliers, with the current one covering 2026 and possibly part of 2027, depending on the timing of the new supplier.

John CoxAnalyst

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?

Jack KhattarCEO

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, and submit it to the FDA. On average, it could be a 6-month review, 9 months review. We will get more clarity fairly soon, in the next month or so. Based on that, we will expect the approval, hopefully. So that's typically the timeline and the kind of package. So the answer is yes, there will be no clinical study or data that you need to provide.

OperatorOperator

Our next question comes from David Amsellem from Piper Sandler.

David AmsellemAnalyst

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 the 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 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?

Jack KhattarCEO

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, we are initiating new patients, not just with the current situation, meaning the 1,800 forms or 700 patients in the process. 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, these are really early-stage assets. For now, we will be doing some early preclinical work, things like that, 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 they will go through the same process of prioritization from a portfolio perspective.

David AmsellemAnalyst

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?

Jack KhattarCEO

Yes, that is correct. We are focused on revenue-generating 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 between '27 and '30, '31 timeframe, that will be something that will be ideal for us.

OperatorOperator

Our next question comes from Stacy Ku from TD Cowen.

Stacy KuAnalyst

Congratulations on the earnings update and the ONAPGO supply update. First, regarding the ONAPGO guidance for the year and the patient demand that analysts are trying to measure, could you discuss the insights on the patient profile since launch? Additionally, what frequency of use are you observing? We want to better understand the potential net pricing for a year of treatment, recognizing there will be a range. That's my first question. Next, about the resumption of new patient initiations for ONAPGO, should we interpret the 1,800 enrollment forms as indicating more limited writing from clinicians despite the supply disruption? Just seeking clarification on that. Lastly, as the sales force engages with clinicians and patients again, what dynamics are you noticing regarding ONAPGO demand and switches? We understand that commercial reimbursement and infrastructure have been progressing even amid uncertainty about supply. Happy to clarify the first question further.

Jack KhattarCEO

Hopefully, I'll be able to address all your points. Let’s start with the first one. Regarding the patient profile, these are individuals who are in the advanced stages of the disease. Many of the oral medications are no longer sufficient for them, resulting in frequent episodes throughout the day. They often do not achieve adequate control with levodopa/carbidopa or any other additional oral therapies they are on. Therefore, from the physician's perspective, these patients would be considered strong candidates for subcutaneous continuous infusion of a treatment that's distinct from levodopa/carbidopa, assuming that’s what the physician is seeking. Looking ahead, in terms of net pricing, it's important to note that our product has only been available for about 8 to 9 months. Over time, we expect pricing to stabilize based on our actions regarding contracting and other factors. Historically, we’ve talked about an average cost of approximately $100,000 to $105,000 annually at the wholesale acquisition cost per patient.

This figure is based on a typical usage pattern that we are starting to better understand, although I don't yet have all the data I would like to provide an accurate assessment of actual usage and frequency. The $100,000 estimate generally assumes about a cartridge per day, more or less, to reach that annual cost. Regarding the 1,800 forms, if I understood the question correctly, think of that number as a broad measure of demand. We provide this figure to give an overview of what the demand looks like. As we process these forms and as patients receive shipments, some forms or patients may be dropped along the way. This is common in any process involving specialty products. Various reasons can lead to patients being lost during the process, such as incomplete information or difficulties in completing the forms. It's often surprising how many calls we have to make, whether to the patient or to the doctor’s office, just to finalize these forms for processing.

Once the hub starts working on these forms and handles insurance reimbursement approvals, more patients could potentially be lost there, too. Additionally, patient circumstances can change, which may lead someone to reconsider their decision. For all these reasons, the initial figure of 1,800 doesn't necessarily result in 1,800 patients at the end. I'm not sure if there was another question following that.

Stacy KuAnalyst

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?

Jack KhattarCEO

For a product, we've typically seen a range between 20% and 30% depending on the quarter. Q1 is usually on the higher end, and then it decreases over time before the cycle starts again. That's generally the range, 20% to 30%. If I had to estimate, it would be a pure guess at this point based on our experience in the category.

Stacy KuAnalyst

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 one-time impacts this winter, just curious how you all are thinking about the following quarter for Qelbree?

Jack KhattarCEO

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.

OperatorOperator

Our next question comes from Kristen Kluska from Cantor Fitzgerald.

Kristen KluskaAnalyst

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?

Jack KhattarCEO

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. We're also having discussions with the third supplier. Our plans, obviously, is we're going to secure the supply for the long term. This is not just a one-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. 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.

Kristen KluskaAnalyst

Okay. You mentioned earlier that you'll have more clarity in about a month. Is that regarding what you specifically need to demonstrate in terms of additional process runs or any stability data you must conduct before getting that approved? Is that correct?

Jack KhattarCEO

Yes. I mean in the next month or so, we will be having more communication with the FDA. We will have more clarity on 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 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.

Kristen KluskaAnalyst

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.

Jack KhattarCEO

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. We want them to continue to submit forms as they had. It was really remarkable the support we got 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. The physicians continue to think of ONAPGO as a 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 overnight where overnight, you're going to initiate another 700 patients. It's going to be over time that given the capacity we have, you have to think about nurses, initiations, all that. 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.

OperatorOperator

Our next question comes from Pavan Patel from BoA.

Pavan PatelAnalyst

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 to start being to expand the absolute number of OB/GYNs and psychiatrists writing their first prescription?

Jack KhattarCEO

Yes, I'll begin with the last question. Regarding ZURZUVAE, we are still in the process of launching the product. Our approach with new products has always been to maintain a continuous launch mindset. As previously stated, the market wasn't fully prepared prior to the launch, as the initial indication was intended to be for MDD rather than PPD. Consequently, we are developing the market concurrently with the product launch. There's still significant work to be done in terms of market education. While the brand has achieved very high awareness, the next step is converting that awareness into action. We need to build confidence among physicians to encourage them to screen, diagnose, and treat PPD. We will persist with the successful programs that Biogen and Sage initiated back when the product was released and continue them into 2025 and 2026. Some may have already seen the advertisement, as we also have direct-to-consumer efforts aimed at educating women and mothers about their condition, encouraging them to seek treatment.

There is effective treatment available, which only requires a 14-day commitment, with benefits noticeable as early as day three. We're just beginning to explore the potential of ZURZUVAE; thus far, we have treated over 20,000 patients, but annually, 500,000 women experience PPD symptoms, and only around half are diagnosed, with 60% to 70% of those receiving treatment. There is a substantial number of individuals who need assistance, and ZURZUVAE is well-positioned to provide that support. As for prescribers, in the early stages of the launch, we're attracting many new prescribers while also maintaining frequency with current prescribers. Data indicates that 70% of current prescribers tend to write repeat prescriptions, which reflects a high satisfaction level with the product and its performance. Once physicians gain the confidence to diagnose and treat and observe positive results from their initial patients, they usually continue to prescribe the product, which is very encouraging at this early stage.

As for ONAPGO, while there is potential for exceeding $70 million, we don’t have definitive information right now to support that. Based on the current demand and data we have, we believe the range is realistically $45 million to $70 million. If we were confident about surpassing $70 million, we would have set a higher target. Nonetheless, we feel optimistic about our current standing with ONAPGO and its supply situation, and our guidance is intended to clarify our expectations on both ends.

Pavan PatelAnalyst

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

Jack KhattarCEO

I'm sorry...

Pavan PatelAnalyst

ONAPGO...

Jack KhattarCEO

Yes. I mean for ONAPGO on the gross to net, as I mentioned earlier, 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.

OperatorOperator

Our next question comes from Annabel Samimy from Stifel.

Jack PadovanoAnalyst

This is Jack on for Annabel. Congrats again on the quarter. Just quickly on 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?

Jack KhattarCEO

Regarding the central nervous system, we have initiated the trial for 820, and enrollment is still in the early stages. Generally, you would anticipate that a major depressive disorder trial would recruit faster than an epilepsy trial. For both 820 and 817, we expect to see data sometime in 2027; it won’t be this year. We hope that as we progress, particularly with 817, the enrollment will improve since epilepsy trials usually face slower recruitment. Additionally, these are multicenter trials, notably for 817, which extends beyond the U.S., potentially leading to slower recruitment. Therefore, we won’t have any data before 2027. As the year progresses, possibly in May or August, we will provide better guidance on whether the data may come in the first half or second half of the year. Regarding business development, we will continue to focus on the CNS domain, whether that pertains to neurology or psychiatry.

While we have indicated a willingness to explore areas beyond CNS, such as women’s health following the Sage acquisition, that remains an area of interest. Our priorities will focus on revenue and cash flow-generating opportunities, particularly later-stage pipeline assets that could lead to product launches between 2027 and 2031. This is the direction we are pursuing. As Tim noted, we have a solid balance sheet, allowing us flexibility regarding potential transactions, whether they involve a product, a company, or a portfolio of products. This flexibility is advantageous for us.

OperatorOperator

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

Jack KhattarCEO

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 now has 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, two products that have been on the market for two years or less and have a significant market opportunity. In addition to our four growth products, we continue to advance our pipeline and 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.

OperatorOperator

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

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