Prepared remarks
Good afternoon, and welcome to the Supernus Pharmaceuticals Third Quarter 2025 Financial Results Conference Call. As a reminder, this conference call is being recorded. I will now turn the conference over to Peter Vozzo of ICR Healthcare Investor Relations representative for Supernus Pharmaceuticals. You may now begin.
Thank you, Raven. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals Third Quarter 2025 Financial Results Conference Call. Today, after the close of the market, the company issued a press release announcing these results. On the call with me today are Supernus Chief Executive Officer, Jack Khattar; Chief Financial Officer, Tim Dec. Today's 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 who may be listening to the replay, this call is being held and recorded on November 4, 2025. 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 will now turn the call over to Jack.
Thank you, Peter. Supernus delivered strong operating results in the third quarter, reflecting continued momentum from Qelbree and GOCOVRI, collaboration revenues from Zurzuvae, and an encouraging start to the launch of Onapgo. With these four growth products, we have built a solid foundation for a new phase of accelerated growth for the company. During the third quarter of 2025, these four growth products accounted for approximately 78% of total revenues. Starting with Onapgo, during the third quarter of 2025, Onapgo generated net sales of $6.8 million, up from $1.6 million in the second quarter. From launch through September 30, 2025, more than 1,300 enrollment forms were submitted by over 450 prescribers. Initial feedback from prescribers has been positive regarding the product and its performance. In addition, prescribers appreciate the high level of service provided by Supernus in its Circle of Care program.
Due to stronger-than-expected demand for Onapgo, supplier constraints are impacting the company's ability to fully meet this demand. As a result of this supply imbalance, the company is prioritizing care for patients currently on Onapgo. This requires pausing delivery to patients who have not started on Onapgo. The company is working to build adequate inventory and resume new patient initiation as soon as possible, and we will provide timely updates as progress is made in resolving the supply constraint. Switching now to Zurzuvae, collaboration revenue from Zurzuvae was $20.2 million in the third quarter of 2025, representing approximately two months of collaboration revenue since the closing of the Sage acquisition on July 31, 2025. Full third quarter 2025 U.S. sales of Zurzuvae as reported by our partner, Biogen, increased approximately 150% compared to the same period in 2024 and approximately 19% compared to the second quarter of 2025.
We anticipate that the integration of Sage will be substantially completed by the end of this year, and we continue to expect potential synergies up to $200 million on an annual basis by mid-2026. Regarding Qelbree, the brand had another robust performance in the third quarter of 2025 with 23% growth in prescriptions as reported by IQVIA and 31% growth in net sales compared to the same period last year. The total ADHD market continues to experience healthy growth with an increase of 12% in prescriptions in the third quarter of 2025 compared to the third quarter of 2024. Prescription growth for the same period in the adult segment was 16%, outpacing the 5% growth in the pediatric segment. Qelbree had a strong back-to-school season with pediatric prescriptions growing by 19% in the third quarter compared to the same period last year, while at the same time, posting robust third quarter prescription growth in adults of 32%.
In addition, the number of prescribers in the third quarter grew by 18% compared to the same period last year. Switching to GOCOVRI, the product continues its strong performance on the back of the momentum it had in the first half of this year. Net sales grew by 15% in the third quarter of 2025 compared to the same period last year behind growth in prescriptions and number of prescribers. Moving on to R&D, for our SPN-443 program, we have selected ADHD as the lead indication. We expect to initiate a Phase I single ascending, multiple ascending dose study in adult healthy volunteers in 2026. We are on track to initiate a follow-on Phase IIb multicenter randomized, double-blind, placebo-controlled trial with SPN-820 in approximately 200 adults with major depressive disorder by the end of 2025. 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 in 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. 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 additional revenue-generating products or late-stage pipeline product candidates. With that, I will now turn the call over to Tim.
Thank you, Jack. Good afternoon, everyone. As I review our third quarter 2025 results, please refer to today's press release that was issued earlier today. Total revenue for the third quarter of 2025 was $192.1 million compared to $175.7 million in the same quarter last year. Total revenue in the third quarter of 2025 was comprised of net product sales of $168.5 million, collaboration revenues associated with Zurzuvae of $20.2 million, and royalty, licensing, and other revenues of $3.4 million. Please note, collaboration revenues represent approximately 50% of the sales of Zurzuvae reported by Biogen. During the third quarter of 2025, collaboration revenues represented approximately two months of sales reported by Supernus from the closing of the Sage acquisition on July 31, 2025. Excluding net product sales of Trokendi XR and Oxtellar XR, total revenue for the third quarter of 2025 increased 30% compared to the same quarter last year.
This increase was primarily due to the increase in net product sales of our growth products, Qelbree and GOCOVRI, as well as from the launch of Onapgo in April 2025 and the additional collaboration revenues from Zurzuvae. For the third quarter of 2025, combined R&D and SG&A expenses were $209 million as compared to $98.8 million for the same quarter last year. Operating loss on a GAAP basis for the third quarter of 2025 was $60.2 million as compared to operating earnings of $40.9 million for the same quarter last year. The change was primarily due to higher SG&A expenses, which included approximately $70 million of acquisition-related costs from the Sage acquisition, approximately $30 million of Sage operating costs in Q3 2025, and incremental intangible asset amortization from Zurzuvae and Onapgo. GAAP net loss was $45.1 million for the third quarter of 2025 or a loss of $0.80 per diluted share compared to GAAP net earnings of $38.5 million or $0.69 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 third quarter of 2025 was $41.9 million compared to $67.7 million in the same quarter of the prior year. Total revenues for the nine months ended September 30, 2025, were $507.4 million compared to $487.7 million in the same period last year. Total revenues were comprised of net product sales of $468.5 million, Zurzuvae-related collaboration revenues of $20.2 million, and royalty licensing and other revenues of $18.7 million. Excluding net product sales of Trokendi XR and Oxtellar XR, total revenues for the nine months ended September 30, 2025, increased 25% compared to the same period last year. Combined R&D and SG&A expenses for the nine months ended September 30, 2025, were $441.6 million as compared to $322.3 million for the same period last year.
The change was primarily due to higher SG&A expenses, which include approximately $70 million of acquisition-related costs from the Sage acquisition and $30 million related to Sage operating costs recorded since the closing of the acquisition on July 31. Operating loss on a GAAP basis for the nine months ended September 30, 2025, was $58.3 million as compared to operating earnings of $60.3 million for the same period last year. GAAP net loss was $34.4 million for the nine months ended September 30, 2025, or a loss of $0.61 per diluted share compared to GAAP net earnings of $58.5 million or $1.05 per diluted share in the same period last year. On a non-GAAP basis, which excludes amortization of intangibles and share-based compensation, contingent consideration, depreciation, and acquisition-related costs, adjusted operating earnings were $110.2 million compared to $135.4 million for the same period last year.
As of September 30, 2025, the company had approximately $281 million in cash, cash equivalents, and marketable securities compared to $454 million as of December 31, 2024. The decrease was primarily due to the funding of the Sage acquisition, partially offset by cash generated from operations. The company's balance sheet remains strong with no debt and significant financial flexibility for potential M&A or other growth opportunities. And as Jack mentioned, the integration of Sage is on track and will be substantially complete by year-end. Now turning to guidance, we are updating our full year 2025 financial guidance primarily to reflect Supernus' strong performance in the first nine months of the year. We expect total revenue to range from $685 million to $705 million, up from the previous range of $670 million to $700 million, comprised of net product sales, Zurzuvae collaboration revenues, and royalty and licensing revenues.
Note that total revenue guidance for full year 2025 assumes approximately $75 million to $85 million of combined net sales of Trokendi XR and Oxtellar XR, up from $65 million to $75 million previously. For the full year 2025, we expect combined R&D and SG&A expenses to range from $505 million to $530 million, unchanged from the previous range. Overall, we expect full year 2025 operating loss in the range of $65 million to $75 million compared to the previous range of an operating loss of $70 million to $80 million. And finally, we expect non-GAAP operating earnings to range from $125 million to $145 million, up from the previous guidance of $105 million to $135 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 over to the operator for Q&A.
Questions and answers
So it looks like our first question will come from Andrew Tsai with Jefferies Institute.
Nice execution this quarter. I wanted to ask on Onapgo. It sounds like it's off to a strong start. And so if you guys could have met all the patient demand this quarter, there were no supply constraints, how many more patients would have received Onapgo? And where would the sales have been?
Yes. Andrew, I'll take that. It's a little bit hard to project these numbers, obviously, as far as to exactly the number of patients we would have had. But the big picture here is the product has been doing amazingly well, exceeding all expectations from a demand perspective, and the response from the physician community, the patient and Parkinson's community has been phenomenal. And we are very committed, obviously, to this product. And our key focus right now is to make sure we take care of our existing patients. We have about slightly more than 400 patients. So we've had significant growth also in the number of patients, obviously, from the last quarter. And as I mentioned earlier, I mean, the feedback regarding the product has been really good. The high level of service we are providing patients and physicians is very much noticeable and very much appreciated in the marketplace because these products need and patients need attention and they care, and that's what we're trying to do here.
So regarding the supply issue, I mean, we will deal with it. That is something we'll be able to overcome. No question about it. We're very committed to Onapgo on the long term as a product. And as I mentioned, I mean, the opportunity here is vast. If you look at the European experience, apomorphine infusion devices have been available for more than two decades actually and have served and helped thousands and thousands of patients. Our intention is nothing less than duplicating that kind of success in the U.S. because we know there are a lot of patients in the U.S. who need and could really take advantage of a product like this. So that's really where we are. But definitely, I mean, we're very much focused on addressing the supply constraint. Hopefully, we'll be able to get everybody who's in the pipeline, so to speak, and start initiating patients again.
And secondly, as a follow-up, just to manage Street expectations, is the supply constraint in such a way where we should be thinking that Q4 might be softer relative to Q3? Or could it still grow because you still have supply, I guess. Like I'm trying to gauge whether there's a potential bolus in Q4 or whether it could actually be softer actually. I don't know how to think about it. But any color would be helpful.
Yes. Yes. I mean the situation changes by the hour because we're working around the clock literally with our suppliers trying to line up more batches, line up more deliveries. So it's a very fluid situation. But since you asked the question, earlier way back when we launched, people asked me, is Onapgo built into the annual guidance? I said, yes, it's in the high single digit for the year. And obviously, we're pretty much already there in a way with the third quarter cumulative year-to-date, we have about $8.4 million. Certainly, we'll have shipments in the fourth quarter, no question about it. It's really hard for me now to tell you today. Is it going to be higher? Is it going to be slightly lower, a little bit more lower because we truly don't know yet, and we don't have a clear picture at this point.
We will now hear from Stacy Ku from TD Cowen.
Great quarter. Congratulations on the strong performance. I have a few follow-up questions regarding Onapgo. First, could you explain what the rate limiting steps are? Also, can you provide a range for the time you expect to resolve this issue? It would be helpful to know both the high and low estimates as you discuss the details, which we appreciate. The second question is about Zurzuvae, which was approved before Onapgo. Given the high demand from patients and the apparent challenges in addressing their needs, should we expect this situation to continue, or will competitors meet that demand? Lastly, shifting topics from Onapgo, could you clarify the margins? They appear to be quite strong this quarter, so I'd like to understand where you expect them to stabilize as more products are launched compared to where they currently stand.
Yes, sure. Yes. I mean the key rate-limiting steps or issues, the constraints we're talking about, it's really a lot of it is capacity. Again, because of the significant demand, it's a high-quality problem, but obviously, we need to address it and make sure we catch up because to your second question, we know patients when we have the enrollment forms, clearly, there is a period of time anyway that happens before initiation, but we do have patients waiting for initiation. So obviously, we're working very diligently to do this as quickly as possible so we can initiate and go back to initiating patients. But we're trying to preserve right now the inventory we have. And of course, we have deliveries coming in, but we're trying to preserve that inventory for people who are already on therapy because, obviously, these are existing patients we need to take care of. Whether so the patients, a lot of them, I guess, will wait.
Some of them may end up going somewhere else. That's okay because once we are back on track, I mean, again, back to the fact that the product is a great product. It's something that is very much needed in this marketplace, specifically because apomorphine is a molecule that treats Parkinson's like any other molecule. It's not another levodopa/carbidopa. It's very much differentiated, and there is a need for it. So we will be able to go through this situation and get that on track at some point. As far as the margins, the margins on Onapgo will end up being pretty close similar to APOKYN from a manufacturing perspective, gross margins because it's under the same setup and partnership with our partner in Europe, who is the licensor. So it's very similar to the APOKYN setup.
Okay. And just to confirm, when you talk about capacity, are you talking about the device or the actual API? Just help us understand what is the supply limitation?
Yes, the issue is related more to the filling of the cartridges. We have no issues with the pump. The challenge lies in scheduling and obtaining sufficient production time at the CRO, specifically for the drug cartridges.
Our next question comes from David Amsellem from Piper Sandler.
I have a question about Onapgo and another about Zurzuvae. Regarding Onapgo, following up on previous inquiries about potential business loss to a competitor, what feedback have you received in the field on that? Additionally, can you provide a sense of how many patients for whom PEFs have already been submitted you expect to retain? Is it the majority, or is it less? Please help us understand this situation and the potential for business loss in more detail. Secondly, concerning Zurzuvae, how many representatives are currently detailing the product, what are your plans for expanding the sales force, and how willing are you to acquire the remaining 50% of the asset from your partner? What are your thoughts on that?
Yes. Starting with Onapgo, the situation regarding potential loss is relatively new, so we haven't had much time to assess it or receive substantial feedback from the field. It's challenging for me to predict the potential loss at this point. However, considering the overall strength of the product and its necessity, it's natural to be concerned about losing some patients to competitors. Nonetheless, if these patients truly need a product like this, once we have the inventory, we are confident that we can bring many of them back. Our insights are based on experiences from patients using Onapgo in Europe for over two decades. The unique attributes of our product compared to other treatments illustrate the demand for it and the clinical validation that shows it provides real benefits to patients. All these factors should help minimize any potential loss over time. Regarding Zurzuvae, we have not disclosed the number of representatives involved, and Biogen hasn’t either.
Given that this is a specialty area in OB/GYN, one can infer the size of the sales force, given the limited number of OB/GYNs in the U.S. The recent expansion occurred in the last quarter of last year into the first quarter of this year, and we are starting to see positive results from that expansion, as the product has shown impressive growth. Regarding further expansion, we remain open to options, though any decisions will require discussions with our partner, Biogen. Typically, we take a measured approach to expansions, ensuring we see returns from the first before considering additional ones. We will approach potential future expansions in the same manner and have conversations with our partner about it. As for our interest in obtaining the remaining 50%, we are very satisfied with the 50% we currently own, which justified the deal we struck. Our relationship with Biogen is strong, and we are always open to discussions.
While I can’t give a definitive answer about acquiring the remaining stake, the product itself offers a significant opportunity, and having the full 100% would certainly present an even greater opportunity.
Our next question comes from Pavan Patel from BofA Securities.
First on net pricing on Onapgo. Can you talk about how we should think about the current gross net deductions versus steady state? And given 2/3 of the patient segment is Medicare, would you expect a 35% gross net deduction? Or could pricing look better on a steady-state basis? And if you can speak to what that gross net deduction looks like currently? And then second question, I think, Jack, at a recent Berger conference, you mentioned from a BD perspective that you would look at assets with synergies to the recent Sage acquisition. Can you provide some more details on that? Does that mean women's health, which is historically a very tough competitive space to play in, or other assets like depression?
Yes, regarding the price, all I can say at this point is that it will fluctuate as the launch becomes more established and as reimbursement processes are set. We expect the annual cost for a patient to be around $105,000 to $100,000, which aligns with other products in this area. In terms of gross to net, we will have a clearer picture in another quarter or so. The numbers are not too far off from what you've mentioned; it might be slightly lower, but we'll see where it settles. We hope to provide more guidance later. On the business development side, as I noted earlier, we are concentrating on potential acquisitions and business development. Our priorities remain focused on commercial stage assets, particularly in CNS, neurology, and psychiatry, and now also in women's health, which is a new area for us. We have a strong commercial infrastructure, so if we find a compelling opportunity in women's health, we will certainly consider it. Additionally, we are looking at neurology, psychiatry, and movement disorder specialists, which synergize with our work in Parkinson's. We are also open to rare diseases because we have a solid patient support framework surrounding our Parkinson's franchise. The women's health segment indeed presents a new opportunity for us that we hadn’t explored seriously before the Sage acquisition, which has enabled us to expand into this area.
And if I could just ask a follow-up question as well. On AbbVie's call, their R&D had walked us through some key differences between Vyalev and Onapgo. And our own work shows that even though Vyalev is expected to capture the bulk of share here, there's a patient segment in which patients would benefit from Onapgo therapy. Maybe if you can help us better understand what is that niche that you're hoping to carve out? And what's the messaging here from your sales force to the movement disorder specialists that treat these patients?
Yes, certainly. I reviewed what AbbVie discussed during their earnings call. We avoid making direct comparisons because there have been no head-to-head trials, which makes it unfair to compare the products. We advise people to review the labels on both products and draw their own conclusions. Ultimately, what matters most to us is the product's usage and the feedback we receive from the market. The performance of our product and the level of service we provide are what truly set it apart from others. Apomorphine has remarkable characteristics; it is a unique molecule that effectively penetrates the brain without protein competition. This means it has excellent penetration, does not require metabolic conversion, and acts like dopamine. Typically, metabolic conversions in Parkinson's patients are carried out by presynaptic neurons, and over time, those neurons can degrade. Since apomorphine acts similarly to dopamine and penetrates the brain well, targeting postsynaptic dopamine receptors and closely resembling dopamine structurally, it stands out as a significant molecule. Very few drugs in the Parkinson's field showcase a similar mechanism. Additionally, regarding our service, I believe we offer exceptional service to our patients, ensuring strong initiation, training, follow-ups, and titration through in-person nursing care that supports our patients comprehensively.
So... Our next question comes from Annabel Samimy from Stifel.
It was a good quarter. Looking at Onapgo and its reception, physicians are clearly interested in the apomorphine molecule, which explains the high demand. Regarding the patients who are starting treatment or filling out the inpatient enrollment forms, are these individuals who have already tried some form of apomorphine? Is there a way to temporarily secure their treatment with apomorphine while you ramp up supply so they don’t switch to a levodopa/carbidopa pump? Can you discuss the dynamics of this situation, especially any potential middle ground until you have the capacity?
Yes, APOKYN and Onapgo are quite different products. APOKYN is intended for the acute treatment of episodes and is administered as a single bolus injection. Onapgo can also provide a bolus injection, but it does not offer the continuous infusion feature that APOKYN provides. Therefore, the physician will need to determine on a case-by-case basis whether APOKYN would be beneficial for a specific patient. Regarding the typical patients we see on Onapgo, some are former users of apomorphine, and we do have patients on Onapgo who previously used APOKYN. We estimate that about 15% to 17% of Onapgo patients have had prior exposure to APOKYN. Historically, we have discussed the potential for cannibalization between the two products. Patients who are using multiple daily injections may prefer the pump option instead. We believe that this segment represents approximately 15% of the business.
Okay. Got it. I know that one key point of differentiation you've always mentioned is safety. Is that resonating with physicians at all? Or are they mainly focused on the type of molecule they want to advance to the next stage of treatment?
Yes. I mean, clearly, again, back to making comparisons and so forth. I mean, if you look at the side effects and the labels of both products, obviously, there are big differences in key areas across the label. Physicians, of course, I mean, they've had scenarios probably. Some patients have some of these reactions, whether on Onapgo or on Vylev or vice versa or what have you. So I mean, at the end of the day, the things that are really driving what we believe is driving and on a recent survey, I mean, we looked at it, and it says basically that the top reasons that is driving physicians to prescribe, number one is the significant improvement they are expecting and would expect from Onapgo for any daily good on time. I mean that's really the top reason they look at and consider when they're considering Onapgo. And then the second is really the positive impact on the quality of life that this product. A lot of these are based on, of course, our data, the clinical studies, and so forth from the products. It's resonating with these physicians. So the sustained also improvement through like week 52. So a lot of these messages we're getting back from the surveys we're doing as to what are the top reasons they think about and the top reasons why they will be considering prescribing kind of ties into the data on the product and the efficacy of the product.
Got it. I have another question regarding the expansion into the OB/GYN space. This area is certainly compelling as an initial point of contact. I'm curious if there has been any resistance from Biogen regarding this expansion, or if they are supportive of it. Also, do you have any insight on when this might take place?
Yes, regarding the expansion of our sales force for Zurzuvae, we will collaborate closely with Biogen. This partnership has been very beneficial. We will need to work together on this. In terms of Supernus expanding into women's health with different brands, that decision is more independent and can be made on our own. Thank you for joining us on this call today. Supernus has a diversified portfolio of growth products where our future success is not solely dependent on one single product. Qelbree's success to date and future growth is augmented by continued growth from GOCOVRI and early growth from Zurzuvae and Onapgo, two products that were launched less than two years ago and that have significant market opportunity. Regarding Onapgo, the company will provide timely updates as progress is made in resolving the supply constraint. We are very focused on these four products and on advancing our pipeline to position Supernus as a long-term growth company while generating 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.
Perfect. I will now close. Thank you so much for the conference today. This does conclude the program. You may now disconnect.