NASDAQ:SUPN Supernus Pharmaceuticals Q3 2025 Earnings Report $51.92 +2.73 (+5.55%) As of 11:52 AM Eastern ProfileEarnings HistoryForecast Supernus Pharmaceuticals EPS ResultsActual EPS$0.46Consensus EPS $0.82Beat/MissMissed by -$0.36One Year Ago EPS$0.69Supernus Pharmaceuticals Revenue ResultsActual Revenue$170.00 millionExpected Revenue$175.82 millionBeat/MissMissed by -$5.82 millionYoY Revenue Growth+9.30%Supernus Pharmaceuticals Announcement DetailsQuarterQ3 2025Date11/4/2025TimeAfter Market ClosesConference Call DateTuesday, November 4, 2025Conference Call Time4:30PM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)SEC FilingEarnings HistoryCompany ProfilePowered by Supernus Pharmaceuticals Q3 2025 Earnings Call TranscriptProvided by QuartrNovember 4, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: Supernus says its four growth products — Qelbree, Gocovri, Zurzuvae (collab), and Onapco — now make up ~78% of revenues, with Q3 sales momentum (Onapco $6.8M; Qelbree net sales +31% YoY) and management raising full‑year revenue and non‑GAAP earnings guidance. Negative Sentiment: The company reported a supply constraint for Onapco (cartridge/filling capacity), pausing new patient initiations to prioritize existing patients, which could temper near‑term growth and risk losing some demand to competitors. Positive Sentiment: Zurzuvae contributed $20.2M of collaboration revenue (≈two months post‑acquisition), Biogen‑reported U.S. sales rose ~150% YoY in Q3, and Supernus expects Sage integration to be substantially complete by year‑end with up to $200M annual synergies by mid‑2026. Negative Sentiment: Acquisition and integration costs from Sage materially lifted SG&A/R&D (combined Q3 expenses $209M vs. $98.8M year‑ago), driving a Q3 GAAP operating loss and reducing cash to ~$281M (though the company has no debt). Neutral Sentiment: Pipeline progress includes SPN‑443 (ADHD lead; phase 1 planned in 2026), SPN‑820 phase 2B in major depressive disorder by end‑2025, and ongoing SPN‑817 phase 2B for focal seizures — early‑stage clinical catalysts with longer‑term upside. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallSupernus Pharmaceuticals Q3 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00All right. Good afternoon and welcome to the Supernus Pharmaceuticals third quarter 2025 financial results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the conference over to Peter Vozzo of ICR Healthcare, Investor Relations Representative for Supernus Pharmaceuticals. You may now begin. Peter VozzoInvestor Relations Representative at Supernus Pharmaceuticals00:00:34Thank 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's Chief Executive Officer, Jack Khattar, and Chief Financial Officer, Tim Dec. Today's call is being made available via the Investor Relations section of the company's website at 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's 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. Peter VozzoInvestor Relations Representative at Supernus Pharmaceuticals00:01:31For the benefit of those who may be listening to the replay, this call is being held and recorded on November 4th, 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 disclaims any obligation to update these forward-looking statements except as required by applicable securities laws. I will now turn the call over to Jack. Jack KhattarCEO at Supernus Pharmaceuticals00:01:58Thank 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 and its Circle of Care program. Jack KhattarCEO at Supernus Pharmaceuticals00:03:07Due 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 ONAPGO. The company is working to build adequate inventory and resume new patient initiation as soon as possible and 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. Jack KhattarCEO at Supernus Pharmaceuticals00:04:18We anticipate that the integration of Sage will be substantially completed by the end of this year. 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. Jack KhattarCEO at Supernus Pharmaceuticals00:05:11Qelbree 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 one single ascending multiple ascending dose study in adult healthy volunteers in 2026. Jack KhattarCEO at Supernus Pharmaceuticals00:06:13We are on track to initiate a follow-on phase II-B multicenter randomized double-blind placebo control 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 2400 mg, given intermittently twice per week as an adjunctive treatment in the current baseline antidepressant therapy. Our phase II-B randomized double-blind placebo control study of SPN-817 is ongoing, with a targeted enrollment of approximately 258 adult patients with treatment-resistant focal seizures. This trial utilizes three milligram and four 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. Jack KhattarCEO at Supernus Pharmaceuticals00:07:22With that, I will now turn the call over to Tim. Tim DecCFO at Supernus Pharmaceuticals00:07:27Thank 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 31st, 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. Tim DecCFO at Supernus Pharmaceuticals00:08:46This 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 addition of 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 cost from the Sage acquisition, approximately $30 million of Sage operating cost in Q3 2025, and incremental intangible asset amortization from ZURZUVAE and ONAPGO. Tim DecCFO at Supernus Pharmaceuticals00:09:50GAAP 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 intangibles, share-based compensation, contingent consideration, depreciation, and acquisition-related cost, 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 30th, 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. Tim DecCFO at Supernus Pharmaceuticals00:11:00Excluding net product sales of Trokendi XR and Oxtellar XR, total revenues for the nine months ended September 30th, 2025, increased 25% compared to the same period last year. Combined R&D and SG&A expenses for the nine months ended September 30th, 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 includes approximately $70 million of acquisition-related cost from the Sage acquisition and $30 million related to Sage operating costs recorded since the closing of the acquisition on July 31st. Operating loss on a GAAP basis for the nine months ended September 30th, 2025, was $58.3 million, as compared to operating earnings of $60.3 million for the same period last year. Tim DecCFO at Supernus Pharmaceuticals00:12:02GAAP net loss was $34.4 million for the nine months ended September 30th, 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, share-based compensation, contingent consideration, depreciation, and acquisition-related cost, adjusted operating earnings were $110.2 million compared to $135.4 million for the same period last year. As of September 30th, 2025, the company had approximately $281 million in cash, cash equivalents, and marketable securities, compared to $454 million as of December 31st, 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 remained strong, with no debt and significant financial flexibility for potential M&A or other growth opportunities. Tim DecCFO at Supernus Pharmaceuticals00:13:17And as Jack mentioned, the integration of Sage is on track and will be substantially complete by year-end. Now turning to guidance, we're updating our full year 2025 financial guidance primarily to reflect Supernus's strong performance in the first nine months of the year. We expect total revenue to range from $685 million-$705 million, up from the previous range of $670 million-$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-$85 million of combined net sales of Trokendi XR and Oxtellar XR, up from $65 million-$75 million previously. For the full year 2025, we expect combined R&D and SG&A expenses to range from $505 million-$530 million, unchanged from the previous range. Overall, we expect full year 2025 operating loss in the range of $65 million-$75 million, compared to the previous range of an operating loss of $70 million-$80 million. Tim DecCFO at Supernus Pharmaceuticals00:14:38And finally, we expect non-GAAP operating earnings to range from $125 million-$145 million, up from the previous guidance of $105 million-$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. Operator. Operator00:15:09Thank you. At this time, we will conduct the question-and-answer session. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. So it looks like our first question will come from Andrew Tsai with Jefferies. Andrew TsaiSenior VP at Jefferies00:15:47Nice execution this quarter, and thanks for taking my questions. Wanted to ask on ONAPGO. 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? Thanks. Jack KhattarCEO at Supernus Pharmaceuticals00:16:09Yeah, 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 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. And 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. Jack KhattarCEO at Supernus Pharmaceuticals00:17:03The 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 the attention and the 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. Jack KhattarCEO at Supernus Pharmaceuticals00:17:36If 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, and 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, and hopefully, we'll be able to get everybody who's in the pipeline, so to speak, and start initiating patients again. Andrew TsaiSenior VP at Jefferies00:18:19Thank you. 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? 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. Yeah. Jack KhattarCEO at Supernus Pharmaceuticals00:18:52Yeah, 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. And it's a very fluid situation. But since you asked the question, I mean, earlier, way back when we launched. People asked me, "Is ONAPGO built into the annual guidance?" And I said, "Yeah, 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? Jack KhattarCEO at Supernus Pharmaceuticals00:19:41Because we truly don't know yet, and we don't have a clear picture at this point. Andrew TsaiSenior VP at Jefferies00:19:49Okay. Sounds like a good problem to have. Thank you. Operator00:19:57All right. We will now hear from Stacy Ku from TD Cowen. Stacy KuBiotechnology Equity Research Analyst at TD Cowen00:20:11Hey there. Hi. Thanks so much for taking our questions in a nice quarter. Congrats on the nice quarter. Some follow-ups on ONAPGO. First. Maybe walk through for us what the rate limiting steps are, and then more specifically, what is the high and low end in terms of the amount of time that you think you'll need to resolve this issue? So just some type of range as you're talking about all these different details, which we very much appreciate. So that's the first question. And then the second, of course, VYALEV was approved ahead of ONAPGO, but just given this really high patient demand and seems like the inability to address what the patients are asking for, are we going to expect this to persist, or are they going to be absorbed by the competitor? So that's the second question. And then. Stacy KuBiotechnology Equity Research Analyst at TD Cowen00:21:04Third, maybe just off-topic from ONAPGO, maybe just help us understand margins. They have looked pretty healthy for this quarter. So just help us understand where they're going to settle as more products are coming on board versus where they are currently. Thanks so much. Jack KhattarCEO at Supernus Pharmaceuticals00:21:21Yeah, sure. Yeah, 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. Jack KhattarCEO at Supernus Pharmaceuticals00:22:06And 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, 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 no any other molecule. It's not another levodopa carbidopa. It's very much differentiated, and there is a need for it, so we'll be able to go through this situation and get back on track at some point. Jack KhattarCEO at Supernus Pharmaceuticals00:22:54As 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. Stacy KuBiotechnology Equity Research Analyst at TD Cowen00:23:14Okay. 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. Jack KhattarCEO at Supernus Pharmaceuticals00:23:27Oh, yeah, sure. Yeah, the issue is related more to the cartridge, the filling of the cartridges. So that's on the pumps. We have no issues with the pump. It's more scheduling, getting enough production time at the CRO, specifically on the cartridges, the drug cartridge. Stacy KuBiotechnology Equity Research Analyst at TD Cowen00:23:47Okay. Understood. Thank you. Jack KhattarCEO at Supernus Pharmaceuticals00:23:49Sure. Operator00:23:59Thank you. Our next question comes from David Amsellem from Piper Sandler. Your line is now open. David AmsellemManaging Director and Senior Research Analyst at Piper Sandler00:24:09Thanks. So I have an ONAPGO question and then also a ZURZUVAE question. So on ONAPGO, just coming back to the previous question about potential lost business to the competitor. I guess the question here is, what have you heard in the field regarding that? And I guess in real time, can you give us a sense of how much of your patients that where PEFs have already been submitted, do you expect to keep? Is that the vast majority? Is it something less? Just help us understand how to think about that and the potential for lost business with some more granularity. So that's number one. And then secondly, on ZURZUVAE. David AmsellemManaging Director and Senior Research Analyst at Piper Sandler00:24:58Can you tell us how many reps you have detailing the product, your plans for sales force expansion, and also your willingness, I guess, and motivation to try to acquire the other 50% of the asset that your partner has? How are you thinking about that? Thank you. Jack KhattarCEO at Supernus Pharmaceuticals00:25:22Yeah. Starting with ONAPGO, I mean, as far as the potential loss, this is a fairly recent situation we're dealing with. So it's not like we've had a long time to evaluate or we've had a lot of feedback from the field around this issue. So it's a little bit hard for me, obviously, to predict what the potential loss. But again, at the end of the day, big picture, given how good this product is and the need for it. Of course, you're always concerned you're going to lose some of your patients to competitors or other products, obviously, out there. But if these patients really need a product like this, once we come back and we do have the inventory, we have good confidence that we can get a lot of these patients back into the product and so forth. And we're talking because basically of experience. Jack KhattarCEO at Supernus Pharmaceuticals00:26:14I mean, the patients who are on ONAPGO, the experience we've seen in Europe for more than two decades, as I mentioned earlier, the differentiation of the molecule versus the other treatments out there, that really speaks volumes for the need for a product like this. But not only the need, but also the validation from a clinical and medical perspective that this is a product that really helps patients out there. So all these factors, hopefully, will obviously limit, reduces, minimizes any potential loss for patients as time goes on. So regarding ZURZUVAE, number of reps, I mean, we haven't really disclosed that. Biogen hasn't disclosed it. But it's really as far as, I mean, this is a specialty area, OBGYN. So you could, in a way, guess how big this sales force can be. Obviously, there's a limited number of OBGYNs you can go after in the U.S. Jack KhattarCEO at Supernus Pharmaceuticals00:27:12And the expansion, I mean, it just happened in the fourth quarter of last year into the first quarter of this year. So we just had the expansion, we meaning Sage and our partner Biogen. And I think, obviously, we're starting to see a lot of the fruits of that expansion, given that the product and the growth of the product with its great performance so far. Would we consider more expansion? I mean, everything is always open as an option for us. Certainly, that is something we will have to discuss with our partner, Biogen, in making these types of decisions. Now, typically on our products, on Supernus, as you guys probably well know and remember, I mean, we typically take expansions one step at a time, make sure the first expansion, we got the return on it. Jack KhattarCEO at Supernus Pharmaceuticals00:28:04It is really proving to be a wise approach, and then whether it verifies another expansion or not. And we'll approach this the same way, and we'll discuss it with our partner as far as potential future expansions. And then as far as our willingness to get the other 50%, I mean. Look, we're extremely happy with the 50% we own. The 50% we purchased on its own merited the deal that we did, obviously. Again, we have a great relationship with our partner, Biogen. I mean, anything could be discussed at any time. So I never say no, but I can give you a definite answer, clearly, that we will definitely get it or not. But I mean, this product is a great product, and the potential. 50% on its own is a great opportunity for us. The 100%, yeah, will be a bigger opportunity, that's for sure. David AmsellemManaging Director and Senior Research Analyst at Piper Sandler00:29:02All right. Thanks, Jack. Jack KhattarCEO at Supernus Pharmaceuticals00:29:04Sure. Operator00:29:17Thank you. Our next question comes from Pavan Patel from BofA Securities. Your line is now open. Pavan PatelBiopharma Equity Research Associate at BofA Securities00:29:25Hey, great. Thanks for taking my questions. 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 two-thirds 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 broker conference, you mentioned from a BD perspective that you would look at assets with synergies to the recent Sage acquisition. Could 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? Thank you. Jack KhattarCEO at Supernus Pharmaceuticals00:30:13Yeah, sure. Regarding the price, I mean, all I can tell you at this point, because obviously it moves and it will move around as the launch gets more cemented, as the reimbursement things are more in place as time goes on. I mean, on a WAC basis, we expect the annual cost for a patient is probably going to be around $105,100,000. Very much in line with the other products in this space. So as far as the gross to net, another quarter or so will give us a little bit more of a better assessment as to where it might be heading. It is not very, very high, so your numbers are not too far off. It might be a little bit lower than that, but we'll see where it lands eventually, and hopefully, we'll be able to give people a little bit more guidance. Jack KhattarCEO at Supernus Pharmaceuticals00:31:06On the BD side, we are, as I mentioned in my prepared remarks, we are very much focused on more potential acquisitions and doing BD. And our priorities haven't really changed as far as what type of assets, meaning commercial stage, will be our top priority, whether that is in CNS, across neurology, psychiatry, and now, of course, to your point, across women's health, given that that's another vertical that we just now have within the company. We have a great infrastructure from a commercial perspective. So if we can find something in women's health that makes a lot of sense, absolutely, that is something we will be considering. But aside from that, clearly, in neurology, whether it's neurology, psychiatry, or movement disorder specialists, that is also synergistic with Parkinson's. So all these areas are obviously things that we look at. Jack KhattarCEO at Supernus Pharmaceuticals00:32:07And we're very open to rare diseases as well because, again, from a patient support, we have great infrastructure around the Parkinson franchise that we have and great services. So we can clearly execute very well around rare diseases as well. So we're very focused on all that. Clearly, the women's health opens up a whole new area for us that before the Sage acquisition was not something we would have looked at, obviously, probably more seriously. But it's an interesting acquisition that we did with Sage that it gave us another vertical that we can look at. And it got us there through a CNS product. So yeah, I mean, it really increases the number of opportunities. In general, I mean, and we're starting to really look at women's health. Yes, you might be right. I mean, the number of opportunities may not be too numerous out there. Jack KhattarCEO at Supernus Pharmaceuticals00:33:01But with time and diligence we'll probably be able to find something. Only time will tell, clearly. Pavan PatelBiopharma Equity Research Associate at BofA Securities00:33:09And if I could just ask a follow-up question as well. On AbbVie's call, their R&D head 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? Thank you. Jack KhattarCEO at Supernus Pharmaceuticals00:33:40Yeah, sure. I looked at what AbbVie mentioned at their earnings call. We try not to make comparisons, obviously, because there are no head-to-head trials. So it's unfair to any of the products to make such kind of comparisons. We just tell people, "Look at the labels on both products and make your own conclusions," so to speak. But at the end of the day, to us, what really matters is how has it been used, and what's the feedback you're getting from the marketplace? I mean, that's really what differentiates your product versus another product, is the performance of that product. The level of service we are providing that surrounds that product, clearly. As I mentioned earlier, I mean, apomorphine is apomorphine. And it has incredible characteristics from a mechanistic perspective, how it works. Jack KhattarCEO at Supernus Pharmaceuticals00:34:37It's a very unique molecule that penetrates the brain, and it doesn't have any protein competition. So in other words, it has great penetration. It doesn't need metabolic conversion. And it acts like dopamine. So typically, the metabolic conversion, for those of you who are very close to Parkinson's, are typically done by the presynaptic neurons. And as time goes on, what happens to these neurons, right? So when you have a molecule that acts exactly like dopamine and really penetrates the brain very well and directly acts on the postsynaptic dopamine receptors, and at the same time, structurally, it's very similar to dopamine, I mean, that's really a great molecule. Not too many drugs in the Parkinson's space have that. Clearly from a mechanism point of view and so forth. So that strongly differentiates apomorphine from the other molecules. Jack KhattarCEO at Supernus Pharmaceuticals00:35:35And again, as I mentioned, as far as our service, I mean, I could say we have maybe best-in-class service surrounding our patients, taking care of our patients, making sure we have great initiation, training, follow-ups, titration, all that is done in person. Nurses that really surround our patients with care. So. Pavan PatelBiopharma Equity Research Associate at BofA Securities00:36:04Thank you. Operator00:36:16Thank you. Our next question comes from Annabel Samimy from Stifel. Your line is now open. Annabel SamimyManaging Director at Stifel00:36:23Hi. Thanks for taking my questions. And again, good quarter. Just going back to ONAPGO and the reception to it, physicians are clearly interested in the apomorphine molecule or else this wouldn't have seen such high demand. So when you think of the patients that are going on treatment or enrolling, filling out the patient enrollment forms, are these patients that have already been on some form of apomorphine? And is there, I guess, a temporary option to lock them into treatment with apomorphine while you're getting supply up and running so that you can sort of not lose them to a potential levodopa carbidopa pump? Can you just talk about the dynamics there for a minute, if there's a middle ground there until they get on board and you have the capacity? Jack KhattarCEO at Supernus Pharmaceuticals00:37:13Yeah. I mean, they're very different products. APOKYN and ONAPGO, APOKYN clearly is for acute treatment of acute episodes. It's a single bolus injection, so to speak. Now, ONAPGO has that capability of giving you a bolus injection. But if you're trying to give an ONAPGO patient an APOKYN product, APOKYN is not going to give you, of course, the continuous infusion. So to speak. So it's a little bit. They're different products. Clearly. From a medical perspective, I mean, the physician will have to decide. Is APOKYN or would APOKYN be helpful for that patient? I mean, that will be decided by the physician, of course, on a case-by-case scenario. As far as the typical patient we're getting on ONAPGO, yes, some of them are used to apomorphine, have used apomorphine before, because we know we have actually APOKYN patients who are on ONAPGO. Jack KhattarCEO at Supernus Pharmaceuticals00:38:11And they have gotten, or some of the forms are from on patients from APOKYN. So yes, the answer is yes. It's not a huge portion. We estimate it's somewhere in the 15%-17%. Is coming from. APOKYN. So yes, these patients would. Have had exposure on apomorphine. They're used to it or what have you, and obviously. And we've said historically, you might remember people were asking about cannibalization and potential of cannibalization on APOKYN. We always said those patients who potentially are taking maybe three injections a day or four injections a day, they may choose to put a pump instead of doing multiple injections a day. And that portion of the business, we always estimated it's probably in the 15%. Domain. Annabel SamimyManaging Director at Stifel00:39:04Okay. Got it. And just, I know that one other point of differentiation you've always pointed to is the safety. Is that resonating with physicians at all, or are they mostly focused on the type of molecule that they want to move forward with as far as next stage of treatment? Jack KhattarCEO at Supernus Pharmaceuticals00:39:23Yeah. 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 and key areas across the label. And physicians, of course, I mean, they've had scenarios, probably. Some patients have some of these reactions, whether on ONAPGO or on VYALEV 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 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. Jack KhattarCEO at Supernus Pharmaceuticals00:40:21And then the second is really the positive impact on the quality of life that this product. And 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 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. Annabel SamimyManaging Director at Stifel00:40:58Got it, and then just one other question going back to expanding into the OBGYN space. Clearly, it's an interesting area as a first point of contact, and I'm just wondering if you're expanding into the space, has there been any resistance from Biogen here, or are they on board with this potential expansion, and do you have any sense of timing when that can happen? Jack KhattarCEO at Supernus Pharmaceuticals00:41:30So you mean expansion of Supernus into other areas in women's health? Annabel SamimyManaging Director at Stifel00:41:35No, into the OBGYN market. As a target audience. Jack KhattarCEO at Supernus Pharmaceuticals00:41:43On ZURZUVAE? Annabel SamimyManaging Director at Stifel00:41:45Yeah. Yeah. Jack KhattarCEO at Supernus Pharmaceuticals00:41:46Yeah. Yeah. Yeah. I mean, as far as the expansion of our current sales force on ZURZUVAE, definitely, I mean, that is something we will work very closely with Biogen. No question about it. I mean. All the decisions around. This is a great and has been a great, great partnership with Biogen across the board. So that is something we'll work and we'll have to work very closely with them. As far as us, Supernus expanding into women's health into other areas with different brands in women's health, obviously, that is more of an independent decision that we can take on our own. Annabel SamimyManaging Director at Stifel00:42:24Yeah. No, I was referring specifically to ZURZUVAE. Jack KhattarCEO at Supernus Pharmaceuticals00:42:29Yeah. Annabel SamimyManaging Director at Stifel00:42:29And, is there any timing on that, or is that just a future goal? Jack KhattarCEO at Supernus Pharmaceuticals00:42:36Yeah. I mean, we don't have any specific time. I mean, we treat ZURZUVAE like we treat our brands. I mean, we're constantly evaluating. We look at it periodically. Do we need to expand the sales force? If so, how big, how small of an expansion? So I mean, we're constantly doing that across all our brands. So I don't have a specific timing. Now, we just got an expansion that just happened basically beginning of this year, more or less, we meaning us and Biogen on ZURZUVAE, right? So we're evaluating that. Did that make a huge impact? Obviously, it is making an impact, as you can see from the results, quarter over quarter. Of course, in addition to the fact we have a lot of other programs happening. It's not just the sales force. So that is a continuous evaluation. Jack KhattarCEO at Supernus Pharmaceuticals00:43:23I don't have a specific timing to tell you. Definitely, we'll do it in 2026 or mid-2026 or 2027. I truly don't have that. Annabel SamimyManaging Director at Stifel00:43:31Okay. Got it. That's great. Thank you. Jack KhattarCEO at Supernus Pharmaceuticals00:43:34Sure. Operator00:43:42I am showing no further questions at this time. I would now like to turn it back over to Mr. Jack Khattar for closing remarks. Jack KhattarCEO at Supernus Pharmaceuticals00:43:51Thank 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. Operator00:44:53Perfect. I will now close. Thank you so much for the conference today. This does conclude the program. You may now disconnect.Read moreParticipantsExecutivesPeter VozzoInvestor Relations RepresentativeTim DecCFOJack KhattarCEOAnalystsAnnabel SamimyManaging Director at StifelStacy KuBiotechnology Equity Research Analyst at TD CowenDavid AmsellemManaging Director and Senior Research Analyst at Piper SandlerPavan PatelBiopharma Equity Research Associate at BofA SecuritiesAndrew TsaiSenior VP at JefferiesPowered by Earnings DocumentsEarnings Release(8-K)Quarterly Report(10-Q) Supernus Pharmaceuticals Earnings HeadlinesSUPN Q1 deep dive: Growth products drive revenue upside, guidance highlights execution challenges1 hour ago | msn.comSupernus Pharmaceuticals’s (NASDAQ:SUPN) Q1 CY2026 Sales Beat Estimates1 hour ago | finance.yahoo.comIran's New Leader Just Said Something That Should Terrify Every AmericanIran's Supreme Leader has declared the Strait of Hormuz closed as leverage against the U.S. - and with 40% of the world's oil passing through that corridor, crude has already crossed $100 per barrel. History shows gold surged 571% during the 1973 oil crisis and 425% in 1979. Today, the U.S. holds 8,133 tonnes of gold valued on the books at $42.22 per ounce - while gold trades above $5,000. American Alternative Assets has released The Great Gold Reset report detailing what this gap could mean for investors.May 6 at 1:00 AM | American Alternative (Ad)Supernus Pharmaceuticals, Inc. (SUPN) Q1 2026 Earnings Call TranscriptMay 5 at 11:01 PM | seekingalpha.comSupernus Pharmaceuticals Earnings Call Signals Growth MomentumMay 5 at 9:10 PM | tipranks.comSupernus Pharmaceuticals (SUPN) Stock Rises on Q1 2026 EarningsMay 5 at 5:50 PM | quiverquant.comQSee More Supernus Pharmaceuticals Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Supernus Pharmaceuticals? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Supernus Pharmaceuticals and other key companies, straight to your email. Email Address About Supernus PharmaceuticalsSupernus Pharmaceuticals (NASDAQ:SUPN), headquartered in Rockville, Maryland, is a specialty pharmaceutical company dedicated to developing and commercializing central nervous system (CNS) therapies. Since its founding in 2003, Supernus has focused on advancing treatments for neurological disorders, with an emphasis on improving patient quality of life through innovative dosage forms and sustained‐release formulations. The company’s marketed portfolio includes Trokendi XR and Oxtellar XR, extended‐release antiepileptic medications designed to maintain stable drug levels for seizure control, as well as Qelbree (viloxazine extended‐release capsules), approved for the treatment of attention‐deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. Supernus also holds rights to Apadaz, an immediate‐release product combining benzhydrocodone and acetaminophen for short‐term pain management. In addition to these approved therapies, the company maintains a pipeline of CNS candidates in development, targeting disorders such as migraine and additional seizure subtypes. Supernus primarily serves the U.S. market through its own commercial infrastructure and works with strategic partners to expand its international reach. The company leverages licensing and collaboration agreements to bring its products to Canada, select European markets and other regions where local regulatory approvals and distribution channels facilitate patient access. Under the leadership of President and Chief Executive Officer Stephan John Davis III, Supernus emphasizes patient‐centric innovation and disciplined execution. Its research and development efforts are complemented by a commercialization strategy aimed at maximizing the impact of its CNS portfolio while exploring opportunities to in-license or acquire complementary assets that strengthen its position in neurological therapeutics.View Supernus Pharmaceuticals ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Years in the Making, AMD’s Upside Movement Has Just BegunOld Money, New Tech: Western Union's Crypto RebootPinterest Pins a Profit Play To Its Mood BoardJust How Big a Problem Could Amazon’s Cash Burn Rate Be?BlackBerry Rewrites Its Own Operating SystemGrab Holdings Faces Hurdles, But Upside Potential Is Hard to IgnorePalantir Drops After a Blowout Q1—What Investors Should Know Upcoming Earnings Coinbase Global (5/7/2026)Airbnb (5/7/2026)Datadog (5/7/2026)Ferrovial (5/7/2026)Gilead Sciences (5/7/2026)Microchip Technology (5/7/2026)MercadoLibre (5/7/2026)Monster Beverage (5/7/2026)Canadian Natural Resources (5/7/2026)W.W. 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PresentationSkip to Participants Operator00:00:00All right. Good afternoon and welcome to the Supernus Pharmaceuticals third quarter 2025 financial results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the conference over to Peter Vozzo of ICR Healthcare, Investor Relations Representative for Supernus Pharmaceuticals. You may now begin. Peter VozzoInvestor Relations Representative at Supernus Pharmaceuticals00:00:34Thank 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's Chief Executive Officer, Jack Khattar, and Chief Financial Officer, Tim Dec. Today's call is being made available via the Investor Relations section of the company's website at 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's 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. Peter VozzoInvestor Relations Representative at Supernus Pharmaceuticals00:01:31For the benefit of those who may be listening to the replay, this call is being held and recorded on November 4th, 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 disclaims any obligation to update these forward-looking statements except as required by applicable securities laws. I will now turn the call over to Jack. Jack KhattarCEO at Supernus Pharmaceuticals00:01:58Thank 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 and its Circle of Care program. Jack KhattarCEO at Supernus Pharmaceuticals00:03:07Due 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 ONAPGO. The company is working to build adequate inventory and resume new patient initiation as soon as possible and 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. Jack KhattarCEO at Supernus Pharmaceuticals00:04:18We anticipate that the integration of Sage will be substantially completed by the end of this year. 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. Jack KhattarCEO at Supernus Pharmaceuticals00:05:11Qelbree 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 one single ascending multiple ascending dose study in adult healthy volunteers in 2026. Jack KhattarCEO at Supernus Pharmaceuticals00:06:13We are on track to initiate a follow-on phase II-B multicenter randomized double-blind placebo control 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 2400 mg, given intermittently twice per week as an adjunctive treatment in the current baseline antidepressant therapy. Our phase II-B randomized double-blind placebo control study of SPN-817 is ongoing, with a targeted enrollment of approximately 258 adult patients with treatment-resistant focal seizures. This trial utilizes three milligram and four 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. Jack KhattarCEO at Supernus Pharmaceuticals00:07:22With that, I will now turn the call over to Tim. Tim DecCFO at Supernus Pharmaceuticals00:07:27Thank 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 31st, 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. Tim DecCFO at Supernus Pharmaceuticals00:08:46This 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 addition of 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 cost from the Sage acquisition, approximately $30 million of Sage operating cost in Q3 2025, and incremental intangible asset amortization from ZURZUVAE and ONAPGO. Tim DecCFO at Supernus Pharmaceuticals00:09:50GAAP 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 intangibles, share-based compensation, contingent consideration, depreciation, and acquisition-related cost, 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 30th, 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. Tim DecCFO at Supernus Pharmaceuticals00:11:00Excluding net product sales of Trokendi XR and Oxtellar XR, total revenues for the nine months ended September 30th, 2025, increased 25% compared to the same period last year. Combined R&D and SG&A expenses for the nine months ended September 30th, 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 includes approximately $70 million of acquisition-related cost from the Sage acquisition and $30 million related to Sage operating costs recorded since the closing of the acquisition on July 31st. Operating loss on a GAAP basis for the nine months ended September 30th, 2025, was $58.3 million, as compared to operating earnings of $60.3 million for the same period last year. Tim DecCFO at Supernus Pharmaceuticals00:12:02GAAP net loss was $34.4 million for the nine months ended September 30th, 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, share-based compensation, contingent consideration, depreciation, and acquisition-related cost, adjusted operating earnings were $110.2 million compared to $135.4 million for the same period last year. As of September 30th, 2025, the company had approximately $281 million in cash, cash equivalents, and marketable securities, compared to $454 million as of December 31st, 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 remained strong, with no debt and significant financial flexibility for potential M&A or other growth opportunities. Tim DecCFO at Supernus Pharmaceuticals00:13:17And as Jack mentioned, the integration of Sage is on track and will be substantially complete by year-end. Now turning to guidance, we're updating our full year 2025 financial guidance primarily to reflect Supernus's strong performance in the first nine months of the year. We expect total revenue to range from $685 million-$705 million, up from the previous range of $670 million-$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-$85 million of combined net sales of Trokendi XR and Oxtellar XR, up from $65 million-$75 million previously. For the full year 2025, we expect combined R&D and SG&A expenses to range from $505 million-$530 million, unchanged from the previous range. Overall, we expect full year 2025 operating loss in the range of $65 million-$75 million, compared to the previous range of an operating loss of $70 million-$80 million. Tim DecCFO at Supernus Pharmaceuticals00:14:38And finally, we expect non-GAAP operating earnings to range from $125 million-$145 million, up from the previous guidance of $105 million-$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. Operator. Operator00:15:09Thank you. At this time, we will conduct the question-and-answer session. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. So it looks like our first question will come from Andrew Tsai with Jefferies. Andrew TsaiSenior VP at Jefferies00:15:47Nice execution this quarter, and thanks for taking my questions. Wanted to ask on ONAPGO. 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? Thanks. Jack KhattarCEO at Supernus Pharmaceuticals00:16:09Yeah, 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 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. And 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. Jack KhattarCEO at Supernus Pharmaceuticals00:17:03The 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 the attention and the 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. Jack KhattarCEO at Supernus Pharmaceuticals00:17:36If 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, and 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, and hopefully, we'll be able to get everybody who's in the pipeline, so to speak, and start initiating patients again. Andrew TsaiSenior VP at Jefferies00:18:19Thank you. 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? 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. Yeah. Jack KhattarCEO at Supernus Pharmaceuticals00:18:52Yeah, 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. And it's a very fluid situation. But since you asked the question, I mean, earlier, way back when we launched. People asked me, "Is ONAPGO built into the annual guidance?" And I said, "Yeah, 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? Jack KhattarCEO at Supernus Pharmaceuticals00:19:41Because we truly don't know yet, and we don't have a clear picture at this point. Andrew TsaiSenior VP at Jefferies00:19:49Okay. Sounds like a good problem to have. Thank you. Operator00:19:57All right. We will now hear from Stacy Ku from TD Cowen. Stacy KuBiotechnology Equity Research Analyst at TD Cowen00:20:11Hey there. Hi. Thanks so much for taking our questions in a nice quarter. Congrats on the nice quarter. Some follow-ups on ONAPGO. First. Maybe walk through for us what the rate limiting steps are, and then more specifically, what is the high and low end in terms of the amount of time that you think you'll need to resolve this issue? So just some type of range as you're talking about all these different details, which we very much appreciate. So that's the first question. And then the second, of course, VYALEV was approved ahead of ONAPGO, but just given this really high patient demand and seems like the inability to address what the patients are asking for, are we going to expect this to persist, or are they going to be absorbed by the competitor? So that's the second question. And then. Stacy KuBiotechnology Equity Research Analyst at TD Cowen00:21:04Third, maybe just off-topic from ONAPGO, maybe just help us understand margins. They have looked pretty healthy for this quarter. So just help us understand where they're going to settle as more products are coming on board versus where they are currently. Thanks so much. Jack KhattarCEO at Supernus Pharmaceuticals00:21:21Yeah, sure. Yeah, 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. Jack KhattarCEO at Supernus Pharmaceuticals00:22:06And 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, 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 no any other molecule. It's not another levodopa carbidopa. It's very much differentiated, and there is a need for it, so we'll be able to go through this situation and get back on track at some point. Jack KhattarCEO at Supernus Pharmaceuticals00:22:54As 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. Stacy KuBiotechnology Equity Research Analyst at TD Cowen00:23:14Okay. 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. Jack KhattarCEO at Supernus Pharmaceuticals00:23:27Oh, yeah, sure. Yeah, the issue is related more to the cartridge, the filling of the cartridges. So that's on the pumps. We have no issues with the pump. It's more scheduling, getting enough production time at the CRO, specifically on the cartridges, the drug cartridge. Stacy KuBiotechnology Equity Research Analyst at TD Cowen00:23:47Okay. Understood. Thank you. Jack KhattarCEO at Supernus Pharmaceuticals00:23:49Sure. Operator00:23:59Thank you. Our next question comes from David Amsellem from Piper Sandler. Your line is now open. David AmsellemManaging Director and Senior Research Analyst at Piper Sandler00:24:09Thanks. So I have an ONAPGO question and then also a ZURZUVAE question. So on ONAPGO, just coming back to the previous question about potential lost business to the competitor. I guess the question here is, what have you heard in the field regarding that? And I guess in real time, can you give us a sense of how much of your patients that where PEFs have already been submitted, do you expect to keep? Is that the vast majority? Is it something less? Just help us understand how to think about that and the potential for lost business with some more granularity. So that's number one. And then secondly, on ZURZUVAE. David AmsellemManaging Director and Senior Research Analyst at Piper Sandler00:24:58Can you tell us how many reps you have detailing the product, your plans for sales force expansion, and also your willingness, I guess, and motivation to try to acquire the other 50% of the asset that your partner has? How are you thinking about that? Thank you. Jack KhattarCEO at Supernus Pharmaceuticals00:25:22Yeah. Starting with ONAPGO, I mean, as far as the potential loss, this is a fairly recent situation we're dealing with. So it's not like we've had a long time to evaluate or we've had a lot of feedback from the field around this issue. So it's a little bit hard for me, obviously, to predict what the potential loss. But again, at the end of the day, big picture, given how good this product is and the need for it. Of course, you're always concerned you're going to lose some of your patients to competitors or other products, obviously, out there. But if these patients really need a product like this, once we come back and we do have the inventory, we have good confidence that we can get a lot of these patients back into the product and so forth. And we're talking because basically of experience. Jack KhattarCEO at Supernus Pharmaceuticals00:26:14I mean, the patients who are on ONAPGO, the experience we've seen in Europe for more than two decades, as I mentioned earlier, the differentiation of the molecule versus the other treatments out there, that really speaks volumes for the need for a product like this. But not only the need, but also the validation from a clinical and medical perspective that this is a product that really helps patients out there. So all these factors, hopefully, will obviously limit, reduces, minimizes any potential loss for patients as time goes on. So regarding ZURZUVAE, number of reps, I mean, we haven't really disclosed that. Biogen hasn't disclosed it. But it's really as far as, I mean, this is a specialty area, OBGYN. So you could, in a way, guess how big this sales force can be. Obviously, there's a limited number of OBGYNs you can go after in the U.S. Jack KhattarCEO at Supernus Pharmaceuticals00:27:12And the expansion, I mean, it just happened in the fourth quarter of last year into the first quarter of this year. So we just had the expansion, we meaning Sage and our partner Biogen. And I think, obviously, we're starting to see a lot of the fruits of that expansion, given that the product and the growth of the product with its great performance so far. Would we consider more expansion? I mean, everything is always open as an option for us. Certainly, that is something we will have to discuss with our partner, Biogen, in making these types of decisions. Now, typically on our products, on Supernus, as you guys probably well know and remember, I mean, we typically take expansions one step at a time, make sure the first expansion, we got the return on it. Jack KhattarCEO at Supernus Pharmaceuticals00:28:04It is really proving to be a wise approach, and then whether it verifies another expansion or not. And we'll approach this the same way, and we'll discuss it with our partner as far as potential future expansions. And then as far as our willingness to get the other 50%, I mean. Look, we're extremely happy with the 50% we own. The 50% we purchased on its own merited the deal that we did, obviously. Again, we have a great relationship with our partner, Biogen. I mean, anything could be discussed at any time. So I never say no, but I can give you a definite answer, clearly, that we will definitely get it or not. But I mean, this product is a great product, and the potential. 50% on its own is a great opportunity for us. The 100%, yeah, will be a bigger opportunity, that's for sure. David AmsellemManaging Director and Senior Research Analyst at Piper Sandler00:29:02All right. Thanks, Jack. Jack KhattarCEO at Supernus Pharmaceuticals00:29:04Sure. Operator00:29:17Thank you. Our next question comes from Pavan Patel from BofA Securities. Your line is now open. Pavan PatelBiopharma Equity Research Associate at BofA Securities00:29:25Hey, great. Thanks for taking my questions. 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 two-thirds 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 broker conference, you mentioned from a BD perspective that you would look at assets with synergies to the recent Sage acquisition. Could 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? Thank you. Jack KhattarCEO at Supernus Pharmaceuticals00:30:13Yeah, sure. Regarding the price, I mean, all I can tell you at this point, because obviously it moves and it will move around as the launch gets more cemented, as the reimbursement things are more in place as time goes on. I mean, on a WAC basis, we expect the annual cost for a patient is probably going to be around $105,100,000. Very much in line with the other products in this space. So as far as the gross to net, another quarter or so will give us a little bit more of a better assessment as to where it might be heading. It is not very, very high, so your numbers are not too far off. It might be a little bit lower than that, but we'll see where it lands eventually, and hopefully, we'll be able to give people a little bit more guidance. Jack KhattarCEO at Supernus Pharmaceuticals00:31:06On the BD side, we are, as I mentioned in my prepared remarks, we are very much focused on more potential acquisitions and doing BD. And our priorities haven't really changed as far as what type of assets, meaning commercial stage, will be our top priority, whether that is in CNS, across neurology, psychiatry, and now, of course, to your point, across women's health, given that that's another vertical that we just now have within the company. We have a great infrastructure from a commercial perspective. So if we can find something in women's health that makes a lot of sense, absolutely, that is something we will be considering. But aside from that, clearly, in neurology, whether it's neurology, psychiatry, or movement disorder specialists, that is also synergistic with Parkinson's. So all these areas are obviously things that we look at. Jack KhattarCEO at Supernus Pharmaceuticals00:32:07And we're very open to rare diseases as well because, again, from a patient support, we have great infrastructure around the Parkinson franchise that we have and great services. So we can clearly execute very well around rare diseases as well. So we're very focused on all that. Clearly, the women's health opens up a whole new area for us that before the Sage acquisition was not something we would have looked at, obviously, probably more seriously. But it's an interesting acquisition that we did with Sage that it gave us another vertical that we can look at. And it got us there through a CNS product. So yeah, I mean, it really increases the number of opportunities. In general, I mean, and we're starting to really look at women's health. Yes, you might be right. I mean, the number of opportunities may not be too numerous out there. Jack KhattarCEO at Supernus Pharmaceuticals00:33:01But with time and diligence we'll probably be able to find something. Only time will tell, clearly. Pavan PatelBiopharma Equity Research Associate at BofA Securities00:33:09And if I could just ask a follow-up question as well. On AbbVie's call, their R&D head 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? Thank you. Jack KhattarCEO at Supernus Pharmaceuticals00:33:40Yeah, sure. I looked at what AbbVie mentioned at their earnings call. We try not to make comparisons, obviously, because there are no head-to-head trials. So it's unfair to any of the products to make such kind of comparisons. We just tell people, "Look at the labels on both products and make your own conclusions," so to speak. But at the end of the day, to us, what really matters is how has it been used, and what's the feedback you're getting from the marketplace? I mean, that's really what differentiates your product versus another product, is the performance of that product. The level of service we are providing that surrounds that product, clearly. As I mentioned earlier, I mean, apomorphine is apomorphine. And it has incredible characteristics from a mechanistic perspective, how it works. Jack KhattarCEO at Supernus Pharmaceuticals00:34:37It's a very unique molecule that penetrates the brain, and it doesn't have any protein competition. So in other words, it has great penetration. It doesn't need metabolic conversion. And it acts like dopamine. So typically, the metabolic conversion, for those of you who are very close to Parkinson's, are typically done by the presynaptic neurons. And as time goes on, what happens to these neurons, right? So when you have a molecule that acts exactly like dopamine and really penetrates the brain very well and directly acts on the postsynaptic dopamine receptors, and at the same time, structurally, it's very similar to dopamine, I mean, that's really a great molecule. Not too many drugs in the Parkinson's space have that. Clearly from a mechanism point of view and so forth. So that strongly differentiates apomorphine from the other molecules. Jack KhattarCEO at Supernus Pharmaceuticals00:35:35And again, as I mentioned, as far as our service, I mean, I could say we have maybe best-in-class service surrounding our patients, taking care of our patients, making sure we have great initiation, training, follow-ups, titration, all that is done in person. Nurses that really surround our patients with care. So. Pavan PatelBiopharma Equity Research Associate at BofA Securities00:36:04Thank you. Operator00:36:16Thank you. Our next question comes from Annabel Samimy from Stifel. Your line is now open. Annabel SamimyManaging Director at Stifel00:36:23Hi. Thanks for taking my questions. And again, good quarter. Just going back to ONAPGO and the reception to it, physicians are clearly interested in the apomorphine molecule or else this wouldn't have seen such high demand. So when you think of the patients that are going on treatment or enrolling, filling out the patient enrollment forms, are these patients that have already been on some form of apomorphine? And is there, I guess, a temporary option to lock them into treatment with apomorphine while you're getting supply up and running so that you can sort of not lose them to a potential levodopa carbidopa pump? Can you just talk about the dynamics there for a minute, if there's a middle ground there until they get on board and you have the capacity? Jack KhattarCEO at Supernus Pharmaceuticals00:37:13Yeah. I mean, they're very different products. APOKYN and ONAPGO, APOKYN clearly is for acute treatment of acute episodes. It's a single bolus injection, so to speak. Now, ONAPGO has that capability of giving you a bolus injection. But if you're trying to give an ONAPGO patient an APOKYN product, APOKYN is not going to give you, of course, the continuous infusion. So to speak. So it's a little bit. They're different products. Clearly. From a medical perspective, I mean, the physician will have to decide. Is APOKYN or would APOKYN be helpful for that patient? I mean, that will be decided by the physician, of course, on a case-by-case scenario. As far as the typical patient we're getting on ONAPGO, yes, some of them are used to apomorphine, have used apomorphine before, because we know we have actually APOKYN patients who are on ONAPGO. Jack KhattarCEO at Supernus Pharmaceuticals00:38:11And they have gotten, or some of the forms are from on patients from APOKYN. So yes, the answer is yes. It's not a huge portion. We estimate it's somewhere in the 15%-17%. Is coming from. APOKYN. So yes, these patients would. Have had exposure on apomorphine. They're used to it or what have you, and obviously. And we've said historically, you might remember people were asking about cannibalization and potential of cannibalization on APOKYN. We always said those patients who potentially are taking maybe three injections a day or four injections a day, they may choose to put a pump instead of doing multiple injections a day. And that portion of the business, we always estimated it's probably in the 15%. Domain. Annabel SamimyManaging Director at Stifel00:39:04Okay. Got it. And just, I know that one other point of differentiation you've always pointed to is the safety. Is that resonating with physicians at all, or are they mostly focused on the type of molecule that they want to move forward with as far as next stage of treatment? Jack KhattarCEO at Supernus Pharmaceuticals00:39:23Yeah. 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 and key areas across the label. And physicians, of course, I mean, they've had scenarios, probably. Some patients have some of these reactions, whether on ONAPGO or on VYALEV 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 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. Jack KhattarCEO at Supernus Pharmaceuticals00:40:21And then the second is really the positive impact on the quality of life that this product. And 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 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. Annabel SamimyManaging Director at Stifel00:40:58Got it, and then just one other question going back to expanding into the OBGYN space. Clearly, it's an interesting area as a first point of contact, and I'm just wondering if you're expanding into the space, has there been any resistance from Biogen here, or are they on board with this potential expansion, and do you have any sense of timing when that can happen? Jack KhattarCEO at Supernus Pharmaceuticals00:41:30So you mean expansion of Supernus into other areas in women's health? Annabel SamimyManaging Director at Stifel00:41:35No, into the OBGYN market. As a target audience. Jack KhattarCEO at Supernus Pharmaceuticals00:41:43On ZURZUVAE? Annabel SamimyManaging Director at Stifel00:41:45Yeah. Yeah. Jack KhattarCEO at Supernus Pharmaceuticals00:41:46Yeah. Yeah. Yeah. I mean, as far as the expansion of our current sales force on ZURZUVAE, definitely, I mean, that is something we will work very closely with Biogen. No question about it. I mean. All the decisions around. This is a great and has been a great, great partnership with Biogen across the board. So that is something we'll work and we'll have to work very closely with them. As far as us, Supernus expanding into women's health into other areas with different brands in women's health, obviously, that is more of an independent decision that we can take on our own. Annabel SamimyManaging Director at Stifel00:42:24Yeah. No, I was referring specifically to ZURZUVAE. Jack KhattarCEO at Supernus Pharmaceuticals00:42:29Yeah. Annabel SamimyManaging Director at Stifel00:42:29And, is there any timing on that, or is that just a future goal? Jack KhattarCEO at Supernus Pharmaceuticals00:42:36Yeah. I mean, we don't have any specific time. I mean, we treat ZURZUVAE like we treat our brands. I mean, we're constantly evaluating. We look at it periodically. Do we need to expand the sales force? If so, how big, how small of an expansion? So I mean, we're constantly doing that across all our brands. So I don't have a specific timing. Now, we just got an expansion that just happened basically beginning of this year, more or less, we meaning us and Biogen on ZURZUVAE, right? So we're evaluating that. Did that make a huge impact? Obviously, it is making an impact, as you can see from the results, quarter over quarter. Of course, in addition to the fact we have a lot of other programs happening. It's not just the sales force. So that is a continuous evaluation. Jack KhattarCEO at Supernus Pharmaceuticals00:43:23I don't have a specific timing to tell you. Definitely, we'll do it in 2026 or mid-2026 or 2027. I truly don't have that. Annabel SamimyManaging Director at Stifel00:43:31Okay. Got it. That's great. Thank you. Jack KhattarCEO at Supernus Pharmaceuticals00:43:34Sure. Operator00:43:42I am showing no further questions at this time. I would now like to turn it back over to Mr. Jack Khattar for closing remarks. Jack KhattarCEO at Supernus Pharmaceuticals00:43:51Thank 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. Operator00:44:53Perfect. I will now close. Thank you so much for the conference today. This does conclude the program. You may now disconnect.Read moreParticipantsExecutivesPeter VozzoInvestor Relations RepresentativeTim DecCFOJack KhattarCEOAnalystsAnnabel SamimyManaging Director at StifelStacy KuBiotechnology Equity Research Analyst at TD CowenDavid AmsellemManaging Director and Senior Research Analyst at Piper SandlerPavan PatelBiopharma Equity Research Associate at BofA SecuritiesAndrew TsaiSenior VP at JefferiesPowered by