Supernus Pharmaceuticals, Inc. Stock

Good afternoon, and thank you for standing by. Welcome to the Supernus Pharmaceuticals Third Quarter 2026 Financial Results Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. Instructions will follow at that time. Please be advised that today's conference is being recorded. I now will hand the conference over to Peter Vozzo of ICR Healthcare Investor Relations Representatives for Supernus Pharmaceuticals. Please go ahead.

Thank you, Angela. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' third quarter of 2026 financial results conference call. After the close of the market, the company issued a press release announcing these results. The people who are going to call with me today are Supernus' Chief Executive Officer, Jack Khattar, and Chief Financial Officer, Timothy Dec. Today's call is being made available via the investor relations section of the company's website at www.ir.supernus.com. Before we begin, I'd like to remind you that we will be making forward-looking statements. All of these statements are based on the beliefs and expectations of management as of today. Actual events or results could differ materially.

We refer you to the documents we and Indivior Pharmaceuticals have filed with the SEC, including in periodic reports under the heading risk factors, which identify important factors that could cause actual results to differ materially from those expressed by the company verbally, as well as statements made within this afternoon's press release. This call is being webcast live, and a link will be found at the Supernus website at ir.supernus.com, and a replay will be made available shortly after this call is concluded. I'll now turn the call over to Jack.

Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us on today's call. Today, we will focus on Supernus' strong 2026 third quarter and year-to-date results, which show the continued momentum across our commercial portfolio, specifically our growth products. After walking through these results, I'll provide a brief update on our transformative merger with Indivior Pharmaceuticals. For the third quarter of 2026, combined revenues of our growth products, Qelbree, Zurzuvae, Onapco, and Gocovri, increased by 43% compared to the same period last year.

Starting with Qelbree in the third quarter, prescriptions as reported by IQVIA grew by 18% over the third quarter of 2025, outpacing the 10% growth in the ADHD market. Net sales were $91 million in the third quarter, representing a 12% increase over last year. Similarly, for the nine months ended September 30, 2026, Qelbree achieved robust growth of 18% in prescriptions and 15% in net sales compared to the same period last year. Net sales for the nine-month period reached an all-time high of $258 million. Qelbree's growth over the last year continues to come from both patient populations, with third quarter adult prescription growth of 25% and pediatric prescription growth of 16%. In addition, the total quarterly number of prescribers for Qelbree reached a high of approximately 46,000.

Moving on to Onapco, during the third quarter of 2026, Onapco generated net sales of $17.1 million, up 27% compared to the second quarter of 2026. Demand for the product continued to be healthy with more than 400 enrollment forms submitted in the quarter. In the third quarter of 2026, prescriptions grew by 17% compared to the second quarter of 2026. As we announced last week, the FDA has recognized seven years of orphan drug exclusivity for Onapco for the treatment of motor fluctuations in adults with advanced Parkinson's disease. This designation validates the urgent need for targeted therapies and helps safeguard continued innovation in a long underserved community. In addition, we submitted a supplemental new drug application to the FDA for a second source of supply with approval expected by mid-year 2027.

Switching to Zurzuvae, Supernus reported $42 million in collaboration revenues in the third quarter and $105 million for the nine-month period year-to-date. The total third quarter 2026 U.S. Zurzuvae sales as reported by Biogen increased approximately by 53% compared to the same period in 2025. In the third quarter of 2026, Zurzuvae saw strong growth in demand with written prescriptions growing 43% and the number of prescribers growing 42% compared to the same period last year. Since launch, 87% of the prescriptions have come from repeat prescribers, and more than 43,000 patients have been treated with Zurzuvae.

Switching now to Gocovri for the third quarter, the brand grew 4% in net sales and in prescriptions compared to the same period last year. Net sales reached an all-time high of $43 million in the third quarter. Moving on to R&D, the SPN820 and SPN817 Phase IIb studies continue to enroll subjects with major depressive disorder and focal seizures, respectively. The SPN443 program is expected to start the Phase I, single ascending and multiple ascending dose study in adult healthy volunteers by the end of 2026.

Now turning to the status of our transformative merger with Indivior Pharmaceuticals, I'm pleased to report that Supernus and Indivior shareholders voted to approve the merger on October 15, and we expect this transaction to close on November 2. As you may have seen earlier today, Indivior's results for the three months and nine months ended September 30, 2026, were also strong and driven by continued record performance of Sublocade. Combined with Supernus' solid performance and output, the new company will be starting from a position of strength with significant earnings and cash flow potential. The combined company will have a commercial portfolio of 11 differentiated medicines across psychiatry, neurology, and addiction with key growth products currently expected to continue growing well into the 2030s.

In addition, we will have the profitability, cash flow generation, and financial capacity to pursue further growth opportunities, including driving growth in our existing commercial portfolio, advancing our novel pipeline, and pursuing future business development. Our near-term priorities are to work through the integration of the two companies, ensure that our key growth drivers remain on track, and to progress our pipeline. Integration planning has been underway, and we remain confident in capturing the $125 million of expected annual cost synergies that we previously discussed. With this merger on the verge of closing, we're entering an exciting new chapter that builds on a strong foundation. We expect to provide combined full-year 2027 guidance in February during the release of fourth quarter and full-year 2026 results. With that, I will now turn the call over to Tim. Thank you, Jack. Good afternoon, everyone.

As I review our third quarter of 2026 results, please refer to today's press release and 10-Q that was filed earlier today. We achieved record total revenue of $226.8 million for the third quarter of 2026, an increase of 18% compared to the same quarter last year. Total revenue in the third quarter of 2026 was comprised of net product sales of $178.6 million, collaboration revenues associated with Zurzuvae of $41.7 million, and royalties, licensing, and other revenues of $6.5 million. Please note collaborative revenues represent approximately 50% of the sales of Zurzuvae reported by Biogen. The increase in total revenues was primarily due to the increase in net sales of our growth products, Qelbree, Gocovri, Zurzuvae, and Onapco. For the third quarter of 2026, combined R&D and SG&A expenses were $153.8 million, as compared to $209 million for the same quarter last year.

Operating earnings on a GAAP basis for the third quarter of 2026 was $21.2 million as compared to an operating loss of $60.2 million for the same quarter last year. The change was primarily due to the acquisition-related costs for the SAGE acquisition in the third quarter of 2025, partially offset by higher revenues. GAAP net earnings was $20.9 million for the third quarter of 2026, or $0.35 per diluted share, compared to a GAAP net loss of $45.1 million, or a loss of $0.80 per diluted share, in the same quarter of last year. On a non-GAAP basis, which excludes amortization of intangibles, share-based compensation, contingent consideration, and depreciation, adjusted operating earnings for the third quarter of 2026 was $55.2 million, compared to $41.9 million in the same quarter of prior year. Total revenues for the first nine months of 2026 were $653.5 million. Excluding net product sales for Kikendi XR and Upstellara XR, total revenues for the first nine months increased 37% compared to the same period last year. Total revenues were comprised of net product sales of $495 million, Zurzuvae-related collaboration revenues of $104.7 million, and royalty licensing and other revenues of $53.8 million. Combined R&D and SG&A expenses for the nine months ended September 30, 2026, were $481.5 million as compared to $444.6 million for last year.

The increase was primarily due to an increase in SG&A expenses associated with the collaboration agreement with Biogen. Operating loss on a GAAP basis for the first nine months was $45.1 million as compared to an operating loss of $58.3 million for 2025. GAAP net loss was $39.8 million for the first nine months, or a loss of $0.69 per diluted share, compared to a GAAP net loss of $34.4 million, or $0.61 per diluted share, in 2025. On a non-GAAP basis, which excludes amortization intangibles, share-based compensation, contingent consideration, depreciation, and acquisition-related cost, adjusted operating earnings for the first nine months were $115.2 million, compared to $110.2 million for the same period last year. As of September 30, 2026, the company had approximately $359 million in cash, cash equivalents, and marketable securities, compared to $309 million as of December 31, 2025.

Now turning to guidance, for full year 2026, the company, on a standalone basis, is raising its financial guidance for total revenue and non-GAAP operating earnings. As such, we now expect full year 2026 total revenues to range from $875 million to $900 million, from the previous guidance of $860 million to $890 million. And finally, we expect full year 2026 non-GAAP operating earnings to range from $160 million to $180 million, up from $150 million to $180 million. Assuming the merger with Indivior closes on November 2, this financial guidance will no longer apply. In terms of the merger, we are extremely excited about the closing of this transformative merger. Since we announced the deal in early August, a tremendous amount of work has been done on planning the integration of the two companies, and we are ready to begin executing that plan next week. As Jack mentioned, we are not providing 2027 guidance today, but we do expect to do that in February of 2027. And finally, before we open the call to questions, please note that we would like to focus the Q&A on Supernus' standalone results and outlook. As you can appreciate, we are limited in what we can discuss during this pending merger at this time. We will do that at the appropriate time. With that, I now turn the call back over to the operator for Q&A.

[Operator Instructions] Our first question comes from the line of Kristen Kluska of Cantor Fitzgerald. Your line is now open.

Hi, everyone. Congrats on all the progress over the last quarter here. A couple of questions from me. First on Zurzuvae, I think the revenues here have been a lot higher than most of us expected when you first did this acquisition, so I'm curious if you and your partner feel like you're in a good position right now in terms of reps, messaging, everything out there or if there's any plans to grow this. And then second question on Onapco, wanted to get an update on the timeline from the enrollment form submission to initial shipment. How has that changed over time, and do you expect it to continue or improve once you get the second source on board next year?

Yes, hi, Kristen. Regarding the Zurzuvae, the brand is doing extremely well, and we're very excited about how it's doing now, but also, more importantly, the future of the product. No matter what metric you look at, it's really been phenomenal as far as the growth of the product. Of course, this year we also started the DTC campaign. We've been very encouraged with what we've seen so far, early metrics, but very good signals that there's a lot of great things that are coming out of that campaign. So that's why we continue to see strong demand behind the product. All-time high metrics across the board, number of prescribers, patients, and so forth. So we're really excited. And so far, if you really look at the product since we launched it, only treated a little bit north of 40,000 patients since launch.

So there is a lot of opportunity in front of us here. There are a lot of MAbs that need to really be aware of the disease, step forward, seek help. So we're doing a lot of programs here to educate not just the consumer, the patient, but also on the healthcare provider side as well to keep that momentum going behind the brand. As far as Onapco is concerned, given that in the second quarter we pretty much relaunched the product and we went through the backlog that we had in the queue, as far as the forms are concerned, and processing them to actual shipments. All that backlog is now behind us, so the third quarter was a nice clean quarter, so to speak, from that perspective and that gave us a little bit more time actually to even try to optimize the process and we've done a lot of optimization and improvement in the process and the processing of the form to shipment. So we are pretty much now back to normal timing as far as processing the form into shipments. We also have even improved a little bit on the conversion from form to shipments.

A little bit every quarter there is more and more improvement as we go on because all the supply issues are behind us right now. And a lot of the folks who are in the queue are pretty much fresh and new forms that have been submitted. So we don't have any more patients who are waiting for a long time to be processed and to get their product and then get the training on it and so forth. So we're pretty happy that all that is behind us. And we continue to look forward here to focus on the demand and continue to build the demand. And on the demand, I mean, similarly, if you look, not different than Zurzuvae, we continue to see very good metrics on that across, you know, different metrics here, the prescription, number of patients on therapy, new writers, all have grown in the quarter versus the previous quarter.

Thanks and all the best into the expected closing of the merger next week.

Our next question comes from the line of Stacy Ku of TD Cowen. Your line is now open.

Hey there. Thanks so much for taking your questions. We have a couple. Something that we get asked by investors is around M&A. So with the merger set to close, Jack, is this a parallel track priority or something that might take some time to contemplate and execute on? So it's the first question that we do get a lot of inbound on. And then a quick follow up as we think about spend and synergies. As a guidance on synergies within Indivior for next year, but maybe also remind us where you are with SAGE and spend, especially with the NYSE survey growth, are there any additional synergies that can be realized over there? Is that all done? And then last on Qelbree, just maybe talk about how net pricing is progressing and maybe expectations for the prescription trajectory for the rest of the year. Thanks so much.

Yes, regarding the M&A activity and whether it's a priority or not, I mean, we're always looking for potential opportunities to continue to grow our portfolio. And this is something that you never, and you're not able really to predict timing of these type of things, but we will continue to be active in looking and searching and identifying and building relationships within the industry, of course, with the appropriate targets and companies that we would like to do and to partnerships with them. As far as the top priorities, of course, six months, you know, after the merger, as I mentioned, I mean, we will be very focused on the integration of the two companies, Indivior and Supernus. So we will have plenty to do there. But during that time, of course, our BD group can continue to search for other opportunities for future potential future transactions. Regarding the synergies, the one as far as the current merger that we're working on, as we mentioned in our prepared remarks, we feel pretty good about the target we put out there, you know, the $125 million on an annual basis. So that we feel will be on track and we're very confident with our ability, you know, to hit that number. And actually more so because we just went through it pretty much related to your second question on SAGE.

We actually hit our target of $200 million on that transaction, maybe a little bit better we did. So we feel pretty good about our chances of, you know, hitting the target we have on the Indivior merger. And then regarding the last question, as far as Qelbree, I mean, overall, big picture, Qelbree is doing really well. We're very pleased with Qelbree and the trends on the prescriptions. I mean, some of the things we haven't really mentioned, we don't talk about, but things like even if you look at new to brand prescriptions are up by like 23% in the third quarter. We had a very strong third quarter, very strong growth in the number of prescribers. So overall, the brand is doing really well on the prescription side and specifically on the adult side, which is a very important segment that we continue to emphasize even during the back to school season, where typically we emphasize a little bit more on the pediatric because we want to build on the momentum of the back to school market dynamics. Even during that quarter, you know, adults continue to outperform the pediatric growth.

So we're very pleased with both segments, the pediatric and the adult, and the product is so differentiated in the marketplace, you know, compared to the existing medications or even the recently approved products, Qelbree has an incredibly unique position in the marketplace, has five years of experience. A lot of people have a lot of experience with the product now. So we really feel pretty good about the position of the product, its delivery and its future. Overall, I mean, we're still around 1% market share and this market has been incredibly resilient and continues to grow at 10% plus in prescription, which is truly amazing in the CNS space. So we feel really good about the future of Qelbree. Thanks so much. Appreciate it. Thank you.

Our next question comes from the line of Annabel Samimy of Stifel. Your line is now open.

Hi, it's Annabel. So just I know you're not really talking about the Supernus and Indivior combination at this stage, but given that the combination is going to supply you with the balance sheet and the additional components, capital to potentially invest more in the space and in your own commercial portfolio? Are there any specific initiatives, commercial initiatives that you're planning that you have been able to do before that could potentially facilitate that continued growth of the projects, like for example, Zurzuvae, have you moved into more of the OBGYN space and are you doing anything there to potentially enhance some of the growth of some of your current portfolio? And then separately on Onapco, the 400 patient enrollment forms, is that a good run rate to start with? Because I know that it was sort of held back a little bit before, then you had a little bit of a bolus. So, what is the right run rate for new patient enrollment forms for Onapco? Thanks.

Yes, regarding the merger, I mean, that goes without saying, we're clearly going to be exploring all potential growth opportunities within the, as I mentioned in my remarks, within our existing portfolio, which would be, of course, Sublocade, Qelbree, and Onapco as well. And so forth. So that will be one of the key areas where we would look at what else can we do? Is there any other programs we would like to consider, you know, and so forth. So that's something definitely we will be looking at to maximize these brands, all of them, and maximize their potential and growth in the future. And then as far as, you know, Onapco and the run rate, I mean, it's been around the 400. It picked up a little bit, but it's been around the 400, 425. You know, it bounces around a little bit. So at this point, it looks like it's a good run rate as an assumption.

Of course, we're working pretty hard to even increase it and continue to know it, hopefully, as time goes on. Great. Thank you.

Thank you. Our next question comes from the line of Chi Phong of B of A. Your line is now open.

Hey, guys. Thanks for taking my questions. First one I have is I want to ask about adjusted operating margin. So looking at the 3Q results in the guidance of the midpoint imply roughly around mid-20% margin, better than the mid-teens in the first two quarters. So as we think about Supernus as the current standalone entity, where's the opportunity for margin expansion next year relative to current level? To assume a higher operating margin than the 20% implied in a 2026 guidance against or support a standalone entity.

Yes, regarding the, I mean, this is a little bit of a difficult question because we're going to assume something that's not going to happen. And the dynamics will change, of course, once you have the merged company, but as standalone and there is no merger or whatever. Clearly, you know, as time goes on, our plan has been to continue to improve our operating margin. So that goes without saying because it's a natural phase that you go through. You go through as you launch products, you invest behind them, you expand, you spend money on, you know, launching some of these products. Naturally, as time goes on, you'll be able to improve the operating margin because your investment level might not be exactly the same forever. You know, you'll do that commensurate with the life cycle of every product. So naturally, the short answer is yes, we would have been able to improve our operating margin.

Of course, these comments only apply to Supernus as standalone. You know, the new company will have a lot of different dynamics at that point.

Got it. My second question, I want to ask about SPN817, which is currently in Phase II development for epilepsy. I'm curious, can you talk about timing of the data and expectation for the readout?

Yes, right now, given the rate of recruitment, it looks like most likely, and we'll confirm that with a little bit more concrete data. We would like to see another quarter of recruitment before we put out a specific target, but it looks like it's going to be in 2028. I don't have more specifics, you know, first second quarter, third quarter, that will come back, you know, with more information as we get better feel for the recruitment. And these epilepsy trials tend to be slow in general. So we're basically going very similar rates as everybody else in the industry and doing these trials. So 2028 will be a good guess, but when in 2028, we'll try to nail it down and get it a little tighter as time goes on.

And if I may squeeze one in, this is a follow-up to Annabel's question earlier. So I'm curious, so obviously more than 400 new forms were submitted for Onapco this quarter, similar to the runway the first couple of quarters. Were you surprised that the number of new forms submitted haven't picked up meaningfully since the resolution of the supply shortage and looking ahead, what are the upside levers that new forms and new scripts could pick up meaningfully from current runway?

Yeah, I mean, the answer to the first question, it wasn't surprising because we knew we were relaunching the product basically. So not that we're starting from scratch, but you know, when you pause for three, four months, the heavy activity from a launch perspective, everybody slows down because of the supply issues. And now you start again, naturally, you know, you are more in a relaunch mode. So we're really actually pretty pleased with the levels of forms that we have. We always would love to have more, don't get me wrong. And clearly, as I mentioned earlier, I mean, now that we have all these issues behind us, the supply, and as I mentioned earlier, the process also has gotten much smoother because the backlog is all cleared up. The conversion could potentially get better.

So, I mean, all these will help us continue to feed the demand. Physicians will get positive and more positive feedback on the experience that their patients are having with the product. So, I mean, all this will help us hopefully even, you know, make this even a much growing number as time goes on, you know, beyond the 400 and go above that. So, clearly, stay tuned to any updates as time goes on, pretty good about the basics for the demand of this product. Okay, great. Thanks so much. Sure.

I am not showing any more questions at this time. I will now turn it back over to Jack Khattar, President and CEO for closing remarks.

Thank you for joining us on this call today. We have positive momentum across our business, as evident with our strong third quarter and year-to-date performance in 2026. We continue to generate strong cash flows behind the strength of our growth products and through the efficiency of our operations. We're very excited about our future as a combined company with Indivior and the value it will create. Thanks again for joining us this afternoon. We look forward to providing you with further updates on our progress.

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

This live transcript is auto-generated without human intervention or review.

Good day, and welcome to the conference call and webcast to discuss the merger of Supernus Pharmaceuticals and Indivior Pharmaceuticals. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your speaker, Peter Vozzo, Investor Relations representative for Supernus Pharmaceuticals. Please go ahead.

Good morning, everyone, and thank you for joining us to discuss the proposed merger of Supernus Pharmaceuticals and Indivior Pharmaceuticals. A press release announcing the proposed merger was issued earlier this morning. Additionally, this morning, both companies separately reported financial results for the 3- and 6-month periods ending June 30, 2026. As a result of the transaction announcement, Supernus and Indivior are hosting this joint conference call in lieu of their previously scheduled second quarter 2026 earnings calls. Note that today's conference call will focus on the transaction.

Before we begin, I'd like to remind everyone that today's discussion regarding Supernus and Indivior includes forward-looking statements, including expectations regarding the proposed transaction. These statements are subject to risks and uncertainties, and we encourage you to review the related SEC filings for more detail. For the benefit of those of you who may be listening to the replay, this call is being held and recorded on August 3, 2026. Since then, the company may have made additional announcements related to the topics discussed.

Now let's turn to Slide 4. I'm joined on the call today by Jack Khattar, President and Chief Executive Officer of Supernus; Joe Ciaffoni, Chief Executive Officer of Indivior; and Tim Dec, Chief Financial Officer of Supernus. Ryan Preblick, Chief Financial Officer of Indivior, is also available for Q&A.

I will now turn the call over to Jack Khattar, President and Chief Executive Officer of Supernus.

Thank you, Peter. Good morning, everyone, and thanks for taking the time to join us on today's call. Let's start with the big picture on Slide 5. This transaction creates a CNS leader through the combination of 2 highly complementary businesses. The combined commercial portfolios will total 11 medicines with key growth products anticipated to grow well into the 2030s.

The merger provides for 4 key commercial therapeutic areas in addiction, ADHD, depression and Parkinson's disease. It also accelerates profitability and cash flow generation with expected annual cost synergies of $125 million, which we expect to realize within the first 12 months following the merger. Our respective teams have spent a great deal of time together identifying and validating these synergies. These synergies are primarily general and administrative redundancies and operational efficiencies that should materialize after the 2 companies come together.

The merger also gives us a strong balance sheet, which enhances our flexibility to pursue future business development and other growth opportunities. Put simply, this combination creates a CNS leader with a diversified portfolio of commercial products, a differentiated and innovative CNS pipeline and significant financial resources to accelerate growth opportunities.

I would now like to turn it over to Joe Ciaffoni, who will provide his perspective on the transaction. But before I do that, I'll take a moment to recognize the dedicated employees of both Supernus and Indivior whose commitment and focus have made today's milestone possible. Joe?

Thanks, Jack, and good morning, everyone. I'm excited to be here with the Supernus team to announce the creation of a new leading diversified CNS biopharmaceutical company with significant scale. Bringing our 2 organizations together is intended to deliver greater value to the patients, health care communities and shareholders we serve. We are excited by the potential of combining our 2 complementary organizations. And importantly, we have a shared vision of improving the lives of people living with CNS and behavioral health diseases.

For Indivior shareholders, our execution against the Indivior Action Agenda has dramatically strengthened the company by accelerating top line growth through strong commercial execution and sustained investment in SUBLOCADE and accelerated the bottom line at an even faster rate by focusing and simplifying the organization. We are pleased that Indivior shareholders will have the opportunity to participate in the upside we see from this combination under Jack's leadership.

The combined company creates a leading CNS-focused biopharmaceutical company that generates over $2 billion in net revenue, comprised of meaningfully differentiated and durable commercial growth drivers, along with an innovative pipeline. We expect the combined company to realize significant cost synergy, which will create meaningful value for shareholders.

As a merger of equals, we are able to preserve balance sheet strength that strongly positions the new company to execute on business development opportunities at a level that neither company could contemplate today on their own. I am optimistic about the future of Supernus, and I am confident that this combination will mark a new phase of growth and value creation. Upon closing of the transaction, all 3 phases of the Indivior Action Agenda will have been successfully completed.

In closing, I want to thank the Indivior team for their contributions to our progress and most importantly, for their commitment to making a positive difference in the lives of people living with opioid use disorder in the communities we serve. Supernus' strength gives us an even greater ability to make a positive difference moving forward.

I'll now turn the call back over to Jack.

Thanks, Joe. So let me provide some further detail. Let's turn to Slide 6. We have structured this merger as an all-stock, tax-free merger of equals, which we believe capitalizes on the strengths of both companies and presents the best value creation opportunities for both sets of shareholders.

Under the terms of the agreement, Supernus shareholders would receive 1.5401 shares of Indivior common stock for each share of Supernus they own. In addition, prior to closing, Indivior will declare a dividend of $1 billion in the aggregate to pre-closing Indivior stockholders. Taking the cash distribution and exchange ratio together, we expect Indivior shareholders to own approximately 56.5% of the combined company at closing, with Supernus shareholders owning the remaining approximately 43.5% on a fully diluted basis.

Our combined Board will include 4 directors from Supernus, including myself, and 4 directors from Indivior, including Tony Kingsley, who will serve as Non-Executive Chairman. Following the close, I will serve as Chief Executive Officer of the combined company with the support of an expanded current Supernus management team.

The combined company will keep the Supernus name and will be headquartered in Rockville, Maryland. We expect the transaction to close in the fourth quarter of 2026, subject to the approval of both companies' shareholders and certain regulatory approvals and customary closing conditions.

Turning now to Slide 7. Here, we lay out what that combined portfolio will look like. As of June 30, 2026, on a trailing 12-month basis, the combined company had approximately $2.2 billion of pro forma net revenue across 4 key therapeutic areas. Indivior brings the leading treatment for opioid use disorder, SUBLOCADE, buprenorphine extended-release injection and Suboxone sublingual film also for opioid use disorder.

By revenue contribution, SUBLOCADE will be the largest single contributor at approximately 44% of pro forma combined net revenue. Rounding out the portfolio are Supernus neurology and psychiatry products anchored by its 4 growth products, Qelbree for ADHD, Zurzuvae for postpartum depression and GOCOVRI on ONAPGO for Parkinson's disease.

Slide 8 speaks to why now. Both organizations are combining from a position of strength and demonstrated progress. Supernus' strategic focus has been expanding its portfolio through growth of its current commercial products, business development and advancement of its mid- to late-stage CNS pipeline of novel assets, and as such, has developed a successful track record of acquiring and integrating businesses.

Against that focus, Supernus has strengthened its presence in neuropsychiatry through the acquisition of Sage Therapeutics in 2025, secured FDA approval and launched ONAPGO for Parkinson's disease and is generating significant free cash flow. Indivior's strategic focus has been implementing its 3-phase action agenda to grow SUBLOCADE, simplify the business and strengthen its financial position. It has become a leader in developing and commercializing treatments to help people achieve long-term recovery from opioid use disorder.

Indivior has accelerated SUBLOCADE growth through improved commercial execution and its direct-to-consumer campaign, simplified the business to reduce operating expenses and generated significant operating leverage. Together, we believe the combined organization is well prepared to drive the next phase of value creation.

Before I hand it to Tim, let me touch on our pipeline on Slide 9. We remain very excited about the innovation and differentiation of our product candidates in development and the opportunity to deliver sustained innovation and growth into the future. The combined company will continue to invest in R&D, completing the development of Supernus' current product candidates, replenishing the pipeline with innovating product candidates from our discovery programs and external collaborations.

With that, let me turn it over to Tim to walk through more of the financial details.

Thank you, Jack, and good morning, everyone. Slide 10 lays out our pro forma key financial metrics for the combined company. For Supernus on a trailing 12-month basis as of June 30, 2026, total net revenue was $830 million and adjusted EBITDA was $150 million, which is an adjusted EBITDA margin of approximately 18%. As of June 30, 2026, Supernus had cash of approximately $372 million and no debt. For Indivior, the corresponding figures for net revenue, adjusted EBITDA and adjusted EBITDA margin were $1.3 billion, $613 million and 46%. As of June 30, 2026, net debt was $251 million and net leverage was approximately 0.4x.

On a combined basis for the 12 months ended June 30, 2026, pro forma net revenue was approximately $2.2 billion, with pro forma adjusted EBITDA of $888 million and a margin of approximately 41%, net debt of $878 million and a net leverage ratio of approximately 1x.

Note, the pro forma adjusted EBITDA figures include the impact of expected cost synergies of $125 million. As we mentioned earlier this morning, Supernus and Indivior reported their respective financial results for the 3- and 6-month periods ending June 30, 2026.

With that, let me hand the call back to Jack.

Thank you, Tim. Let me bring this all together on Slide 11 because I think it's the clearest summary of why we're doing this. This transaction enhances and diversifies our growth profile. It gives us a differentiated portfolio with key growth products expected to grow well into the 2030s. It also establishes us in 4 key commercial therapeutic areas in addiction, ADHD, depression and Parkinson's disease. And it also provides increased scale and significant cost synergies. It gives us meaningfully greater flexibility and capacity to pursue growth initiatives, both organic and through business development opportunities that neither Indivior nor Supernus could contemplate on their own today.

Turning now to Slide 12. Taken together, we see this as a value-creating transaction for shareholders of both companies to accelerate profitability and cash flow generation and provide the combined company greater financial flexibility and capacity to pursue growth opportunities. We see that flexibility supporting 3 key priorities: First, driving growth in our combined commercial portfolio, including continued investment behind the combined company's growth products, SUBLOCADE, Qelbree, Zurzuvae, GOCOVRI and ONAPGO; second, advancing our novel and innovative pipeline of product candidates; and third, pursuing future business development and other growth opportunities.

With that, I will now turn it over for a question-and-answer period.

[Operator Instructions] And our first question will come from the line of Andrew Tsai with Jefferies.

Congratulations on the merger. So for the -- it looks like the transaction you said helps you guys do BD deals in the future that neither company could contemplate by yourself. So can you talk about what kind of firepower we're talking about and what kind of indication areas that companies jointly might be interested in now?

And then secondly, what do you foresee the peak sales of SUBLOCADE to be? And why should it fundamentally outperform competitors in the space? And then maybe just on top of that, the consensus EBITDA estimates on the Indivior side, it seems like a material step-up in 2027. So how comfortable are you guys with that directionally speaking?

Andrew, thanks for the questions. I'll start with the first one and then Joe can step in on the SUBLOCADE questions. Regarding business development, our strategy will continue to be very focused and disciplined as we've always done over the years. Clearly, CNS is our mainstay, and that's what we continue to focus on from a therapeutic area. We've been always open to considering other areas. Of course, women's health is another vertical that we have, and these are the 2 areas we'll continue to focus on in general.

As far as the capacity, as Tim walked you through the pro forma, and this is more on the pro forma basis, you'll see that the adjusted EBITDA is very, very healthy. And in general, our philosophy, we don't try to overleverage from a business perspective and taking on a lot of debt. So we're very comfortable typically with the 2.5x, maybe 3x adjusted EBITDA from a multiple perspective. And as I always say, I mean, it always depends on the quality of the assets that you're bringing to the table and the cash flows that are coming with that acquisition. A little bit more sustainability of cash flows, healthier, higher quality of cash flows, maybe you can go on the higher upper end of the multiple clearly. But that's really the guideline that we will continue to pursue as we move forward after the closing.

And Andrew, with regards to SUBLOCADE, I appreciate the question. I would emphasize SUBLOCADE is the first. It's the #1 prescribed and it's a meaningfully differentiated long-acting injectable. Importantly, I believe we're just beginning to scratch the surface of SUBLOCADE's potential. Now as a matter of policy at Indivior, we give no peak sales guidance. But what I would emphasize is we believe the runway for SUBLOCADE is durable. We believe the product will continue to grow.

If you look at this quarter, every fundamental metric in support of SUBLOCADE is trending in a strong direction. And I would close with in the quarter, we had record new patient starts. We've seen stable market share at 76%, which has now been about 6 or 7 quarters where we see share stabilizing there. And the most important thing that we're focused on because there's such opportunity is driving long-acting injectable utilization. And so there's a long runway in front of it.

And our next question will come from the line of Glen Santangelo with Barclays.

Jack, I just had a couple of quick ones here. I was curious, could you guys give us the pro forma total shares outstanding and maybe pro forma debt and cash for the combined company? I think that would be helpful as we start to think about our models.

And then, secondly, while the expense synergies obviously seem like they make sense given the combination, you talked a fair amount about the enhanced growth profile of the company. And I was curious, since you're not detailing any sort of revenue synergies, I was kind of curious, could you talk about why you think this will enhance the growth profile? I mean, can you leverage the 2 commercial sales forces that you have in place? And any enhancements you think the combination will create on the R&D side? Any sort of comments there would be helpful.

Yes, sure. Let me start first with the second part of the question, and then Tim can jump in on the other side. As far as the expenses, synergies and so forth. Now if you look historically, we've made several acquisitions. And obviously, we've been able to integrate them very well. And this is not going to be any difference. So this merger will certainly take advantage of certain redundancies that the 2 organizations naturally bring together. There are natural redundancies that will result in the $125 million cost synergies that we talked about.

Now clearly, there is more as after we close and we look into the operation, we will, of course, focus on those because we are always driving for efficiency in the operations across all the groups. As far as revenue and growth profile, so what do we mean by enhancing the growth profile? Basically, what you have with the combination, you have now 5 or you will have 5 growth products across different therapeutic areas. All growth products have been supported very well by the separate companies, of course. But when you have much deeper and larger financial resources, you can continue to reexamine the portfolio, the growth potential of these products and try to maximize the potential of these products.

So these will be the opportunities that we will look for to be able to enhance the growth profile in general. But then enhancing the growth profile of the total company could also mean -- that means we'll bring other products from the outside. And given the expanded capacity that I mentioned in my previous remarks, the flexibility that we would have from a financial perspective, that will give us tremendous firepower that otherwise we don't have. And that would allow us to bring even more products into the portfolio and enhance the growth of the total company in general. And that is really what is so unique about this combination.

It's that firepower and the powerful advantages that it brings to the table, which, again, you'll hear us say that many times that otherwise, each of us separately won't be able to do. And it's really giving our shareholders combined a great opportunity to benefit from a profile that probably doesn't exist today in this space. If you look at the CNS space, I'll guarantee you there are not too many companies with a profile like the one we just gave you from a pro forma perspective, and that is a huge opportunity for people to participate with the upside of such a combined company.

Yes. And Glen, you had asked about the number of shares outstanding post deal. With the exchange ratio for the Supernus shares at 1.54, the aggregate number of shares will be about 215 million.

And can we get the total cash and debt numbers pro forma?

So on the financial slide, our pro forma EBITDA is roughly $888 million. We're not going to provide any guidance going forward other than the pro forma number. And our net debt number is $878 million.

One moment for our next question. And that will come from the line of David Amsellem with Piper Sandler.

So a couple for me. Jack, I wanted to come back to your comments on more business development flexibility. So you have a history of doing primarily commercial stage transactions. And just given where the organization will be, the combined organization, I wanted to get a sense from you regarding your appetite for late-stage assets, earlier development stage assets and further rounding out the pipeline? And how aggressive will you be given that you have additional firepower? So that's number one.

And then number two, maybe more of a question for Joe is how you're thinking about the exclusivity runway for SUBLOCADE. So this is going to be the combined organization biggest selling product or should be. So the question is, given its profile, can you talk to barriers for potential generics in addition to just the IP? In other words, complexities, just given that it's an LAI product, I think that would be helpful in terms of teasing out what your assumptions are for the runway for that product.

Yes. David, I'll take the first question and Joe can jump in on the second one. As far as our priorities from a BD perspective, you're absolutely right. We've been prioritizing, of course, commercial stage assets to continue to diversify our revenue base. And clearly, this merger will do that, and we'll do that in a great amazing way because it really gives us not just diversification, but also gives us the scale. And the scale is going to be the factor that will allow us together with the financial resources on the R&D side to continue to invest in our current pipeline with the 2 assets that are mid- to late-stage accelerate some of them if we can.

If we can, obviously, we will look into all that, but also continue to add to the pipeline. And that's what I tried to say when I said replenish our pipeline assets, add to the pipeline. Now adding the priority will be and will continue to be mid- to late stage. We do have a fairly significant discovery efforts at Supernus, which we used to have before the Sage acquisition, and then we augmented our capabilities with the platforms that came from Sage. And at the right moment, we will be disclosing at some point the fruits of those programs and the kind of molecules that we're working on and so forth. So most likely, again, we will be -- continue to focus on the mid- to late-stage assets from a pipeline perspective.

And David, as it pertains to SUBLOCADE, and I appreciate the question, we believe SUBLOCADE has a long durable runway in front of it and a very strong growth opportunity. From a manufacturing perspective, the only comment I'll make is a very complicated product to make as a sterile injectable -- sterile long-acting injectable in an aseptic manufacturing process.

To this point, there have been no Paragraph IVs. And I think in part, that's due to the complexity associated with manufacturing SUBLOCADE. We have 12 Orange Book-listed patents that go from 2031 out to 2038. And we also have applied for and are pursuing additional patents anchored most commonly to the new label that we received in February of 2025 that if granted, would take IP out to 2042 to 2044. So we're very confident in both the growth profile of SUBLOCADE and the durability of the runway.

One moment for our next question, and that will come from the line of Dennis Ding with Jefferies.

I have 2. So number one, talk about the $125 million in annual synergies and where exactly that's coming from? And from my experience from covering Indivior, that tells me the number is very conservative. So I'm wondering if we should expect Indivior's OUS business to be further site down as another source of upside on EBITDA. So that's question number one. And question number two is just I'm curious around your views around some of the competitive threats over the next few years, whether it's GLP-1s in OUD or perhaps even orexins into ADHD. And just any kind of comments on how to frame some of those readouts and the potential impact to the underlying business would be helpful.

Yes. I'll take first the question on synergies. As I mentioned earlier, naturally, when you have 2 organizations coming together, there will be natural redundancies across -- we mentioned the G&A space clearly. And these are about synergies that come out of the combination. Clearly, Joe and his team have done a remarkable job for the last 12 months or more doing extremely as far as simplifying the organization, as Joe mentioned, making the operation as efficient as possible. So the synergies we are talking about is in the area of where we combine the 2 organizations and create additional opportunities that don't exist when the 2 companies are separate. So hopefully, that's a little bit more helpful as to the kind of synergies.

I think the only thing I'll add is that we mentioned in our prepared remarks that we've been very active in acquiring and integrating companies. And when we set a number, we guarantee we'll get to that number, and we've done that in the past.

On competitive threats, I'll start, Dennis, as it pertains to SUBLOCADE. When we look at the horizon for SUBLOCADE, we see -- we don't see threats, we see opportunity. And one, you have an amazing unmet need. There's a small percentage of people with OUD who are being treated, and there's only 10% LAI penetration. And I would say it's actually unfortunate that we don't see other medications coming to the market because we think there are certainly room for innovation.

Interestingly, you raised GLP-1s. As you know, those studies are early on. They're certainly not a threat as there -- the studies are being done as an adjunctive treatment to buprenorphine. So we continue to believe buprenorphine will be a foundational treatment for people who are living with OUD for the long haul.

And I would add, I mean, regarding your portion on the orexin in ADHD, clearly, again, not too dissimilar from the GLP-1s on the OUD space. It's still early to tell. Until we see some real human data to show us that they do work or they don't work, we'll find out. But in general, again, looking at the ADHD category, and we've been at now for close to 30 years, actually, it's remarkable that it's been very limited to only very few molecules. So there is a huge room here for innovation, new molecules, new entrants into the marketplace. So we're very used to competition. We've done it so many times before.

Qelbree has done amazingly well in the past 5 years. Actually, it's been the fastest-growing brand in the category and one of the most successful launches, although we launched in the middle of COVID actually. So we welcome innovation. We welcome competition. It just makes us better and sharper and be able to even perform better. So that is yet to be seen and whether that's a nonstimulant, it's a stimulant, there's a lot of questions, of course, about bringing a whole new class into the category.

One moment for our next question, and that will come from the line of Kristen Kluska with Cantor Fitzgerald.

Congratulations on this announced merger. So from the SUBLOCADE side of things, I know unfortunately that this is a very large market. But I'm curious how the companies are thinking about synergies to have more patients seek these treatment options. I understand that there's still a lot of room on the table just in terms of patients that are seeking therapies. And then I'm also curious, while recognizing there are other -- that these are different indications, how the psychiatry and addiction use disorder verticals can kind of go hand-in-hand with the sales force, just given there are some similarities in doctors they see while, again, recognizing different indications here.

So Kristen, this is Joe. I'll start. With regards to SUBLOCADE, when you look at the OUD market, there are about 8 million, 9 million people who misuse opioids in the United States. There are 4 million or 5 million who are diagnosed with OUD, and there are 2 million who are being treated with buprenorphine. So I think the real key for SUBLOCADE and growth gets to, one, as we continue to get better with commercial execution, which we still have significant runway to improve, we have seen from Phase I of the Indivior action agenda generate momentum, SUBLOCADE do better.

The second thing and the biggest lever that we have pulled from an investment perspective is all around educating, driving awareness and encouraging people living with OUD to seek treatment. And if I were to say one thing that is really driving the results that you saw today in the quarter and the optimism for the future is there really hasn't been that level of education and awareness brought to the OUD community. And so that's a key lever that is one that I think will continue to drive patients to seek treatment for their OUD.

I would just add, I mean, I think part of your question also was as far as overlap from a physician audience or what have you. There is not really too much of an overlap between the 2 spaces. Yes, we are, of course, in psychiatry with the ADHD sales force. But SUBLOCADE will require a different attention, different audience clearly between the treatment clinics, the different health systems that deal and help these patients at a state level, federal level and so forth. So there are separate markets. There might be very, very slight overlap from psychiatry in general, but not really anything that we can see that could make a huge difference here.

So Supernus, moving forward at closing and forward, we will continue to have -- and we see ourselves having 4 different sales forces. Clearly, we have the ADHD sales force. We'll have the Parkinson's sales force, the OB/GYN sales force and the current sales force that continues and will continue to support SUBLOCADE.

One moment for our next question, that will come from the line of Chase Knickerbocker with Craig-Hallum.

Congrats on the announcement here. Maybe just another one on synergies. So you kind of mentioned $125 million was largely coming from G&A. Can you maybe just kind of discuss what additional synergies you could potentially harvest either within sales and marketing or potentially other kind of manufacturing consolidation rationalization? Just any sort of other kind of avenues for upside on the cost synergies is kind of when we're getting that?

Yes, sure. I mean I can't be too specific at this point. Again, I would emphasize the 2 areas that we mentioned, the redundancies that you typically expect in a merger like this, specifically on the G&A side. But I will really refer to what Tim mentioned. I mean, historically, if you look back at our track record when we look at acquisitions and so forth, the most important thing, first of all, is to make sure the business continues to be healthy. We continue to serve our patients. We continue to make sure the business continuity and the strength of the business.

But certainly, as we go through that and as time goes on, more or less, I can tell you, you can be assured that if there is an area that we can get synergies from, we will definitely do it because that's the mode of our operation of our philosophy in running companies is to run them efficiently and get out of them as much synergies as possible and continue to build for the future so that we can use our dollars, our capital allocation in the right places in the investment behind the brands and into further business development. So that I can assure you, but I can be a little bit more specific right now. As time goes on, potentially, we can be a little bit specific later.

One moment for our next question, and that will come from the line of Christian Glennie with Stifel.

I suppose the first one would be just circle back maybe on Joe from a sort of Indivior's perspective. Obviously, it was [ long ] was lining up sort of the Phase III and you would have considered a lot of things in that presumably and things about acquiring products, acquiring other businesses as, I guess, a stand-alone Indivior versus where you've ended up now in this merger situation. So just a bit more if I can push you on some of the things that you looked at, maybe why those were less attractive seemingly than this transaction.

And then secondly was just on SUBLOCADE, you talked about greater potential for further investment through the combination of the 2 companies. You've obviously spent quite a bit and got some impact from a DTC campaign. But just wondering if your sales force is sort of fully rightsized for that opportunity. We know that a competitor in your space around [indiscernible] talks about significant enhancements to their sales force recently, seemingly to claim they're on sort of a par with where you guys are at. But just wondering if that's something that the pure sort of sales force size is rightsized for the scale of the opportunity in SUBLOCADE.

Yes. So Christian, I appreciate the questions. First off, obviously, as we were moving into the breakout phase, we had a full scan of the landscape, thought through many different things. I can assure you from our perspective, this is the most compelling and best opportunity. And what's special about this is the fact that we had 2 companies that share values in terms of patient centricity that are complementary and that come into this from a position of strength. With such a focus on patient and shareholder value, we were able to accomplish what I would say is seldom done, which is a merger of equals, which preserves balance sheet strength.

Now if you look at the breakout phase for Indivior specifically, we had outlined 4 or 5 priorities and versus each one of those, this deal more than addresses the priority. So the first was we wanted to enhance and diversify our growth profile through the addition of commercial assets. The going-forward company will have 11 marketed products. It will have 5 growth drivers, 4 of which are durable into the 2030s. We said we wanted to introduce because there was nothing that we were interested in acquiring an OUD, the company to a new therapeutic area. The combined company will be in 4 therapeutic areas.

We said we always look for deals that would have meaningful cost synergies to create value for shareholders. This combination has over $125 million at least in cost synergies. And of course, as I already commented, the MOE preserves balance sheet strength. And then the final thing that we believe is that there is also the potential for multiple expansion that will take a value-creating deal to potentially an even higher level of value creation. So we couldn't be more excited about this opportunity, and we're certainly very optimistic about both day 1 performance of the combined company and the amazingly bright future that can be achieved at Supernus.

And I would add, I mean, likewise, on the Supernus side, we have been very active on the M&A space. And as you would expect, we have also looked at several numerous opportunities over the years. And we've been very impressed with what Indivior has been able to accomplish with Joe and his team, really get the company to where it is today and our team, of course, at Supernus to get Supernus as to what it is today that made this possible. I mean that is truly -- and that's back to the one of the slides we said, why now? Why doing it now? Because we view this as being the ideal time for 2 companies that have done so much, progressed so much or in a position of strength, getting together and creating a very powerful combination that otherwise would not exist. So we're extremely obviously excited about this combination.

And then, Christian, to your SUBLOCADE question, and I'm going to talk a bit about both organizations from this perspective. What I'm really excited about under Jack's leadership is when you look at his track record as a CEO and the deals that he has done, he has maximized top line value and achieved cost synergies. When you look at Indivior, I think often people focus too much on the cost synergy versus the fact that we were able to generate momentum, accelerate SUBLOCADE to a level that nobody was anticipating.

So it is about the top line. And then yes, we simplified the organization and improved our cash flow generation. So I'm very confident as the combined company moves forward, that the acceleration of SUBLOCADE will continue under Jack's leadership. And as he's commented on multiple times, the goal from a commercial perspective is to have minimal to no disruption and to let the train continue to roll.

One moment for our next question. That will come from the line of Chi Fong with Bank of America.

I just want to follow up on the business development. As you think about potential opportunity with mid- to late-stage assets, are there certain CNS subcategory or indication areas you would be most interested in looking at? Would it be an area where either Supernus or Indivior already has a presence in? Or would the company look into white spaces where neither [indiscernible] are currently operating in yet?

Yes. Naturally, we will want to build on the commercial pillars, the 4 key commercial areas that we've talked about, right, ADHD, addiction, depression, Parkinson's disease. But also beyond that, I mean, we are very agnostic to psychiatry and neurology in general. And even if it bleeds into women's health, we talked about women's health as well in the past when we did the Sage acquisition. We have a great sales force and infrastructure there that we would want to also build in and add more efficiencies to that infrastructure as we move forward. But to your question specifically as far as CNS per se, I mean, we are agnostic on the psychiatry, neurology side.

We can handle all kind of products, even products in CNS that are rare diseases because as you guys know, we do have the infrastructure also to work with rare diseases as well. So at the end of the day, we will scan the landscape as we always do, and we already have done it many, many times, and we will focus on those assets that clearly are going to take us into the 2040 and 2050 and beyond as far as quality assets, innovative assets and assets that have tremendous longevity as we move forward.

[Operator Instructions] Our next question will come from the line of Annabel Samimy with Stifel.

Congratulations on the merger. Very interesting. I'm hoping that maybe you can talk a little bit more about the broader class for opioid use disorder. The oral market seems to be a good leading indicator for the long-acting injectables. So how should we think about the broader class growth there and maybe the bottlenecks for continued usage or increased usage? And then for the LAI class, specifically for SUBLOCADE to grow beyond the 10% penetration, you mentioned education, but is there any kind of payer pushback or government pushback, physician reluctance or patient reluctance? Anything where you can, I guess, find further opportunity to drive penetration of LAI into the broader class?

So Annabel, I appreciate the question. First off, when you think about the market, the BMAT market, the orals are the feeder to long-acting injectables. So there are very few patients that ever first start on a long-acting injectable. One of the things that is interesting is we have made significant and sustained investments in our consumer. We're actually seeing a pickup in the growth rate of the oral market, which we view as a positive because as a leader that has been committed to this space for over 25 years, our first consideration is trying to ensure appropriate patients that are contemplating recovery get treated.

As it pertains to long-acting injectables and SUBLOCADE specifically, there are no bottlenecks that we see. So patients have access. We have broad availability over 85%, both within commercial and Medicaid. The one thing that is different about a long-acting injectable is the patient that considers an LAI is often more serious, maybe has experienced more ups and down in their treatment journey, and they're now ready to take the step to a sustained long-acting treatment.

And then the final thing, which gets to my comment of we're just scratching the surface. If you think about SUBLOCADE, which has been on the market for 8 years, we did research prior to deciding to make the huge investment in consumer that we did for the #1 prescribed market-leading product, the prompted awareness amongst buprenorphine users, either on buprenorphine oral or recently was only 15%. In our most recent research we did, that is now up to 50%.

And so the point there is the notion of educating, driving awareness and encouraging patients who are struggling with OUD to seek treatment. We're just scratching the surface, and you're seeing the pickup in both the growth rate of the oral market, certainly SUBLOCADE, and you're seeing long-acting injectable penetration continue to increase, and we believe that will be the case with sustained investment and improved commercial execution.

Fantastic. And if I can just ask a quick follow-up. On operating synergies, you cited the little over 40% for the pro forma. Do you expect expansion of that? Or is that -- should that be a steady go-forward number that we think about?

Yes. I mean, typically, the synergies, Annabel, are the first year you get the most benefit out of the synergies. Of course, as we move forward and continue to move forward, we would like to always improve. We would like to always do better. But I can't make any forward-looking statements at this point as far as '27 or any other years. But I can assure you, as you have followed us for a long time now, we will definitely look for areas, as I mentioned earlier, any areas to continue to improve from an operating leverage perspective, we will definitely do that, certainly.

I'm showing no further questions in the queue at this time. I would now like to turn the call over to Mr. Jack Khattar for any closing remarks.

Thank you. We are very excited about our future as a combined company and the value it will create. We look forward to continuing to engage with all of you as we progress toward closing the transaction. In the meantime, both Supernus and Indivior will continue to operate as 2 separate and independent companies. We're grateful to both teams for the work that got us to this point and are even more energized about the work ahead. Thank you for joining us on the call this morning, and we look forward to updating you on our progress.

This concludes today's program. Thank you all for participating. You may now disconnect.

Let me remind that we're going back to normal, so to speak, initiating new patients back to the right track in launching the product. And March was the first month, of course, full month since we made that change and reinitiation of patients. And we're very pleased with all the metrics in March from prescriptions, number of prescribers, the activity behind the brand across several measures. So in certain cases, actually even higher than before the supply constraints. So we're very pleased with that rebound.

And the key is, of course, to continue to work through the backlog that the supply constraint has created because interestingly, the demand continued to be strong despite the supply constraints. Physicians continue to submit patient forms. They realized they -- we were very transparent with everybody about the supply situation. And despite that, they continue to line up patients and put them on the wait list, so to speak, and submit their forms to get on ONAPGO at the right time. So we're very encouraged by that. We got about 500 new forms during the fourth quarter of last year in the thick of the supply constraint and another 400 forms even in Q1 of 2026. So we're very pleased with the demand. And clearly, now we're very focused on processing these as quickly as possible and getting them through the process to create new shipments and new patients on therapy.

Okay. Great. I recall there were, I think, roughly around 570 forms that were in queue. And you mentioned 400 forms that were newly submitted. Maybe can you just walk us through the dynamics here? And typically, as you see on your end, what's the typical turnaround time and success rate for conversion of these forms?

The forms were 400 that were generated in the queue and about that were generated as new forms. And the 570 are the number of patients who are in the queue, they are in the process waiting to get the shipment. So there are two different numbers, obviously. And these numbers are always fluid, and it's always in flux because we always continue to add to the funnel with new forms and then we continue to process some. And also some of them basically drop off because the process is too lengthy or the medical condition of the patient changes over time for a host of reasons. Sometimes some of these don't really translate in the actual patients.

But all in all, I mean, the process takes several weeks. Unfortunately, through the process, you have different inefficiencies. I mean, you'll be amazed, sometimes we get the forms and half of them don't have all the information that is required. So you have to go back to the physician's office. You have to go back to the patient. You have to look for the new -- the information that's missing. Without that information, the hub can't really process these forms. And then you have to go through the insurance. I mean, for all kind of reasons, it takes several weeks for a form to actually translate into an actual shipment.

And just to confirm, the 400 new forms and the 570 that are in queue, those are mutually exclusive.

Yes, that's correct.

Okay. So we talked about 970 forms, if I do the math correctly.

That's right.

Okay. Got it. Does Supernus have a dedicated team helping with the processing these enrollment forms?

Yes. I mean we have different teams at different stages of the process. So you have folks who help the physician's office and making sure the forms are completed, follow-up with patients and so forth. Then you have field reimbursement specialists that work hand-in-hand with the hub services to get the insurance process going, making sure all the information is there for the process and for the approval to come in. Then that goes to the pharmacy for shipments. So we have people who follow up with the pharmacy to make sure they ship on time and so forth.

And also on the other receiving end, we have the nurses who get notified that a patient is ready to be initiated and therefore, these nurses call up patients at home and they set up an in-home visit. So we do that very high-quality in-home visit with the patient to get them initiated on the drug, train them on how to use the pump, the device, go through the instruction, the titration, which is very important and so forth. And once they're initiated, we follow up with them. So it's not like a onetime visit and that's it. We follow up with phone calls. We even follow up with visits if that is needed. And also some of the nurses as well, they loop back into the physician if there is important medical information that they gain during that process that they believe the physician should know about the patient and what they're going through and so forth. So it's really a full service that we provide our patients to make sure the use of the product is as easy as possible for them.

Just to follow up on the number of new forms, 500 in 4Q, 400 in 1Q. So help us understand, does that reflect a fluctuation in terms of demand on new starts? Or did you guys stop taking new forms because of supply constraint?

Well, you have to factor also Q1. I mean Q1 typically is slower in general, aside from supply issues or on any product, even some of our other products. So Q1 typically is a slower month in general. So that's what you're seeing probably there. Nothing too much I would read into 500 in Q4, but only 400 in Q1. So yes, I mean, it's fairly solid across.

I'm probably barking up the wrong tree here, but given the demographics of these patients tend to be older, do you think maybe 1Q, you're seeing some winter storm across the nation maybe contributing to some of these slower new starts?

I mean there's no question we did have disruption, but I really like to use excuses like this, so to speak, because the demand softens. But I mean, there's always some of that, that happens in winter times. I mean we face that most of the times, yes, absolutely. Because if your rep is out of the field for 2 days out of 5 days, I mean, that's a lot of time for that 1 week out of the month. So yes, I mean, it did impact it.

Okay. Fair. So I think there were 2,200 enrollment forms submitted by 645 prescribers so far since launch. Maybe if I do my math right, 3 to 4 forms per prescriber. So curious, can you talk about opportunity to expand on both the breadth and the depth of prescribing?

Yes. I mean, certainly, we're still in the real early, early times here. I mean we just launched the product a year ago. So clearly, we haven't reached every physician who is a potential prescriber here. Those we have reached, we certainly haven't hit them with the frequency that typically requires behavior -- is required to have behavior change as far as prescriptions are concerned. So there is a long way for us here to continue to build not only on the base, continue to increase the number of prescribers, but we also have a lot of prescribers who are what we say I mean, they're adopting the product, but they're kind of dabblers, so to speak, they dabble with 1 or 2 prescriptions, and therefore, we push pretty hard to get more depth into that practice.

Because if you're a physician, I mean, we see obviously your prescription. And if you've been prescribing for 3, 4 months in a row, 1, 2 prescriptions, clearly, you're happy with the product. Otherwise, you'll stop prescribing it. If you are happy with the product on 1 or 2 patients, why wouldn't you expand the use of the product? So we clearly challenge you in a nice way, of course, why wouldn't you put more patients on the product? What is it that's holding you back? And we challenge physicians and make sure they do present ONAPGO as a clear option for a lot of their patients.

Okay. Great. So your current guidance for ONAPGO is $45 million to $70 million. And I assume that taking into some assumption of a range of scenario on both demand and supply side. And one of the questions that have come up during the quarter was let's just take demand out of the equation. How many patients can you supply with the current supplier? Or alternatively can you supply above the guidance?

I mean, clearly, when we came up with this guidance, the $45 million to $70 million, we have several things factored into it, not just demand, not just supply, not just even the resources are required to process the demand because I could have all the supply in the world, but if I can't process these forms and get the insurance process and all that, it doesn't matter how much product I have in the warehouse. So you really need all these factors, and that's what the guidance is built on, not one specific factor.

Now simplifying it, if you look at $45 million or $70 million, basically, $70 million means you have to have somewhere around 700, 800 patients all year round on ONAPGO. I mean that's really what translates to about $70 million. And the current supplier who we have, we felt very comfortable. They should be able to meet that kind of demand. Otherwise, our guidance would have been different if we felt supply is going to be a bottleneck or what have you. So we feel very comfortable with the guidance we gave. We didn't change the guidance recently in May in our earnings call. But typically, we like to make any changes if they are warranted. We like to make them more in August time frame because you have a nice 6 months behind you. You really have a very good eye on the trend and what's happening through the year and you have a better -- instead of doing changes early in the year, and then you have to change it back again later on.

Okay. So you've also guided to bringing the second supplier up by mid-2027. So another question that I've got after the quarter was how good of a handle you have on the timing? And what do you see as the biggest unknown in terms of the FDA review process and time line?

Yes. We have actually a pretty good feel for the timing, specifically the submission. So I mean, we know what we need to do. We've produced the batches already. We put them on stability. So now it's just a matter of reading the stability, put the reports together and make the submission. So there is really nothing holding it up from that perspective. And therefore, we feel pretty good about the submission in the third quarter.

Now is it July? Is it August? Is it September that I can't predict it to the month or to the week or what have you. And remember, summertime is summertime in Europe. So -- but anyway, so we will be filing in the third quarter, and we have a pretty good feel for that. Now the question is review time. We think the review time is more like 6 months, but sometimes because you have an inspection here that will be required, this is the first time this facility will be sourcing product to the U.S. market, and therefore, the FDA has to inspect the facility. It's in Europe. That we don't have control over, obviously. And that's why we gave a window of 6 to 9 months, so to speak. So if we do file in the third quarter, 6 months review will get you into the end of Q1, and 9 months review will get you into the midyear of 2027. I mean, simplistically that -- but we feel pretty good about the timing, of course, of the submission.

Okay. Great. Another question that's come up after the quarter was when and to what extent you can negotiate with the first supplier or current supplier to improve or increase the capacity, and that's any time before the second supplier becomes online?

Yes. I mean all this has actually been worked out and have been done already before we even announced that we're back on track, meaning we've looked into 2026. We've looked at the capacity of the current supplier and what they can do. We've looked at the second supplier and what is the potential timing bringing them online. So we've looked at all that clearly in the different scenarios or potential outcomes that could happen. And we felt pretty comfortable clearly not just meeting the 2026 supply requirements, but also the 2027.

And in 2027, I mean, once we get the second supplier, it doesn't mean I stop getting product from the current supplier. I mean these are not necessarily mutually exclusive. We will have two suppliers, helping us meet the further extra growing demand in 2027. And I did mention occasionally that we also have a third supplier that we're lining up, of course, because we believe the demand will be there for the product, and we will need the capacity. And even without the third supplier, I mean, the second supplier has a much bigger capacity, much larger capacity than the current supplier. So the two suppliers together will be adequate for 2027, no question about it, accounting for growth, of course. And then beyond that, we will have even a third supplier on top of that.

Okay. Great. On the earnings call, you talked about the evolving demographic differences between ONAPGO and Vyalev. And so I'm curious if -- based on this learning, how much you refine your commercial strategy to maximize ONAPGO sales opportunity?

Yes. I mean, big picture, this actually supply-constrained situation, interestingly, if it highlighted something to me, it highlighted one very important aspect, and that is ONAPGO and VYALEV are very different products. And there is a need for both of them, and they can very well coexist together, and there is a different patient for a different product here. And clearly, even during the time when we had the supply constraint, we still generated significant demand.

So clearly, these two pumps are not interchangeable. They're not substitutable. They're not -- and physicians view a lot of different patients that need different therapies here. And of course, the main difference is you have a different drug. They're both infusion devices, but clearly, they're very different drugs. And you have patients who may never continue to be able to benefit from levodopa/carbidopa and therefore, a physician might want to give them something else like apomorphine, which is ONAPGO or a physician might feel, now, you know what, a levodopa/carbidopa in a different form may still benefit that patient, so let me try the other infusion device and so forth.

And of course, over the years, I mean, you're going to have patients who may try both or who may switch from one versus the other because they are different devices, different drugs. They have different profiles in general, the way they are used, conveniences, AEs, they're all -- it's a different product, obviously. But all in all, I think we are both ourselves and our competitor, we're building a whole new segment here together, a whole new area, which didn't exist about a year ago or 1.5 years ago. And it sounds like the demand is fairly robust for both products, and physicians are really responding pretty well with all kind of patient types and putting a lot of different patients on these infusion devices.

Okay. Okay. Yes. So curious if you have any thoughts about what's the expected duration of therapy for ONAPGO as state. And you have been running some long-term extension studies to evaluate safety and adherence data for ONAPGO such as the infusON trial. So curious, any learnings there? And what's your expectation on typical duration of therapy for ONAPGO?

Yes. What we really have the best things we have is a few studies that actually have been done in Europe because in Europe, the apomorphine infusion device has been available for decades, a couple of decades if not more than that. So there has been several studies following different sets of patients over time. And it varies -- it's all over the place. It's a little bit hard for us to say anything specific on ONAPGO now because it's still early, and we don't have real-time real-world evidence, so to speak.

But if you look at these studies, it really varies between as low as 6 months on the product and as long as 6 years or even longer than that. Now clearly, you've got to keep in mind, this is an elderly patient population. So years and years and years, it becomes very difficult after that because a lot of these patients, unfortunately, their medical condition really gets worse over time or they have other complications. But on an average, there are studies that show a median of around 4 to 6 years that people stay on these infusion devices, but it could be as little as 6 months. And if they do go through it at 6 months, it could be because they titrated so quickly, they couldn't tolerate the nausea.

From our experience so far, what we're finding out is if you do the titration the right way through the nurse and the training that we provide, actually, a lot of patients don't even feel nausea. But you have to do it patiently, you have to titrate slow and low and you'll be able to tolerate the medication. And if you do tolerate the medication, I mean, we could see how you could stay on the drug for 6 years or whatever if we end up duplicating the European experience.

Okay. That sounds great. One of the questions that's come up was IP runway for the product. Can you talk about the key IP protections, any room for IP extensions and sort of like the complexity of the product, having a device and different components, does it make it harder to genericize?

Yes. We -- what the drug has today, ONAPGO has is drug -- orphan drug designation. The FDA is still reviewing and hasn't ruled yet on the 7-year exclusivity. So we're waiting for that. That's really the protection that we have on the product. Clearly, it's not a simple product, as you pointed out, and everybody knows, we went through several rounds on the regulatory side to get this product. It's a fairly complex drug device combination. So these are not easy products.

Now it doesn't mean people will not try. Of course, you give people a lot of time and a lot of money. They can figure out something at some point, right? But that's really the protection that we have with the product. Also, you need a lot of infrastructure around the product and services because the product is not just the product itself. We provide, as I mentioned, a lot of services with it as well.

Great. Maybe the last few minutes, we should talk about Qelbree. Is your nonstimulant drug for ADHD, 6 in the market, double-digit growth still. So can you talk about the opportunity here and the company's strategy for driving sustained growth for the near future?

Yes. Qelbree has been a great success for us. As you mentioned, we are into year 6 already in May, starting year 6 on the market. And we just -- with our earnings call, we reported 27% growth on the adult prescription base, 16% pediatrics. I mean, the growth continues to be very robust. As a reference, I mean, last year, we did 935,000 prescriptions in a market which is 111 million prescriptions a year. So we clearly still have a huge potential for a novel nonstimulant that actually works. We've had nonstimulants in the past, fairly limited number, but we've had them, but they really don't work as well at all.

And Qelbree significantly differentiates itself by the fact that it works as early as week 1 for children. For adults, maybe 2 weeks because you may have to titrate a higher dose and you can find out whether it really works for you or not. for adults, which has been a major growth area for us, the market is about 70% of the prescriptions is for adults. In our case, it's only 30%. So we still have way even more room on the growth on the adult side. And there, what we are finding out that a lot of adults are starting to appreciate the fact that Qelbree is an all-day drug. It truly gives you all-day coverage.

A lot of adults supplement their controlled release stimulants with immediate release stimulants later in the day because they lose coverage, a lot of XR controlled release stimulants only last 12 hours, 13 hours, 14 hours, maybe. So if you need and you have a longer day, a lot of them supplement with the immediate release stimulant. And many of these adults are finding out that once they start using Qelbree, they don't need anything else to be sure because Qelbree gives you true 24-hour coverage. And therefore, it makes a big difference for them with a product like this.

Also in adults, there's a lot of comorbidities, and we've generated very good data in a Phase IV study on the use of Qelbree in ADHD plus anxiety, ADHD plus depression and so forth, and we publish the data and so forth. That is not something on our label. Clearly, we don't promote it, but it's something that physicians have asked for as far as to help me understand how can I use the product in adults. and we generate very strong data in co-administration of Qelbree also with stimulants, and that has been published as well.

So we have a tremendous amount of data surrounding the product, which also ties into its mechanism of action, which is a multimodal pharmacodynamic profile, hitting not only on the norepinephrine but also on the serotonin modulation, which is very important in ADHD and more and more data and evidence has been surfacing lately about the serotonin aspect and the treatment in ADHD. So all in all, that has helped us significantly and continue to grow the product, specifically in the adult population.

Maybe last 20 seconds, any thoughts on the orexin role in ADHD? We cover Alkermes following the data. You're going to have some early Phase Ib data later in the year. So curious if you have any thoughts on orexin role in ADHD.

I mean it remains to be seen clearly as far as the -- whether the preclinical models will end up translating into human data. I mean preclinical models tend to be predictive in certain cases in CNS than not. But it will be interesting to see what the first in-human data shows.

Okay. Great. We are out of time. Thanks so much, Jack, for joining us today.

Thank you. Thank you.

Good afternoon, and welcome to Supernus Pharmaceuticals First Quarter 2026 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to Peter Vozzo of ICR Healthcare, Investor Relations representative for Supernus Pharmaceuticals. You may begin.

Thank you. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals First Quarter 2026 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; 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' current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the Risk Factors section of the company's latest SEC filings. Actual results may differ materially from those projected in these forward-looking statements.

For the benefit of those of you who may be listening to the replay, this call is being held and recorded on May 5, 2026. Since then, the company may have made additional announcements related to the topics discussed. Please reference the company's most recent press releases and current filings with the SEC. Supernus declines any obligation to update these forward-looking statements, except as required by applicable securities laws.

I'll now turn the call over to Jack.

Thank you, Peter, and thanks, everyone, for taking the time to join us on today's call. Supernus's first quarter results reflect a strong start to the year, including a 56% year-over-year increase in combined revenues of our growth products and an 11% year-over-year increase in adjusted operating earnings. Starting with ONAPGO. During the first quarter, ONAPGO generated net sales of $8.4 million, reflecting a partial benefit from the resumption of new patient initiations in February 2026. We are pleased with the rebound in the business since we resumed patient initiations with some of the metrics in March reaching or even exceeding levels achieved before the supply constraints. For instance, prescriptions in March reached 463, exceeding the level reached in October 2025 before the supply constraints. Also, the number of prescribers in a single month with shipments to patients increased in March to the highest level since the launch of the product.

Overall, more than 645 prescribers have submitted approximately 2,200 enrollment forms since the launch of the product through the end of April 26. We are also pleased with the progress with the second supplier on ONAPGO. We expect regulatory submission to the FDA in the third quarter of this year with potential approval before midyear 2027.

Switching now to ZURZUVAE. Supernus reported $27.6 million in collaboration revenues in the first quarter. Full first quarter 2026 U.S. sales of ZURZUVAE as reported by Biogen increased approximately 100% compared to the same period in 2025. In the first quarter of 2026, ZURZUVAE saw strong growth of 82% and 73% in written prescriptions and number of prescribers, respectively, compared to the same period last year. Since launch, 85% of the prescriptions have come from repeat prescribers and more than 29,000 patients have been treated with ZURZUVAE.

Regarding Qelbree in the first quarter and as reported by IQVIA, prescriptions grew by 19% compared to the same period last year, outpacing the 10% growth in the total ADHD market. Net sales of $78 million represented a strong 20% increase over the first quarter last year. Despite typical first quarter headwinds, Qelbree's growth continues to be solid and is coming from both patient populations with adult prescription growth of 27% and pediatric prescription growth of 15%. In addition, the total quarterly number of prescribers for Qelbree reached a high of approximately 43,000 with adult prescribers for the first time surpassing the number of pediatric prescribers.

Switching now to GOCOVRI. For the first quarter of 2026, net sales reached $35.2 million, increasing by 15% compared to the same quarter in 2025. Total number of prescriptions grew by 7% in the first quarter of 2026 compared to the same period last year.

Moving on to R&D, the follow-on Phase IIb randomized, double-blind, placebo-controlled trial with SPN-820 in approximately 200 adults with major depressive disorder is ongoing. This study will examine the safety and tolerability of SPN-820 and its efficacy at a dose of 2,400 milligram given intermittently twice per week as an adjunctive treatment to the current baseline antidepressant therapy. Our Phase IIb randomized, double-blind, placebo-controlled study of SPN-817 is also 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. And for SPN-443, our novel stimulant ADHD product candidate, we expect to initiate a Phase I single ascending and multiple ascending dose study in adult healthy volunteers in the second half of 2026.

Finally, corporate development will continue to be a top priority for us as we look for additional strategic opportunities to further strengthen our future growth and leadership position in CNS through revenue-generating products or late-stage pipeline product candidates.

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

Thank you, Jack. Good afternoon, everyone. As I review our first quarter 2026 results, please refer to today's press release and 10-Q that was filed earlier today. We achieved total revenue of $207.7 million for the first quarter of 2026, an increase of 39% compared to the same quarter last year. Total revenues were comprised of revenues from our commercial products, including ZURZUVAE collaboration revenues and royalty, licensing and other revenues. Revenues from commercial products increased to $178 million, a 26% increase compared to the same quarter last year. This increase in revenues from commercial products was primarily due to the increase in net sales of our growth products, Qelbree, GOCOVRI and ONAPGO, as well as the addition of collaboration revenues from ZURZUVAE.

In addition, revenues from royalty and licensing and other revenues were $29.3 million. This includes $20 million of licensing revenues related to the achievement of a commercial milestone under the company's collaboration agreement with Shunovi. For the first quarter of 2026, combined R&D and SG&A expenses were $164.6 million as compared to $116.9 million for the same quarter last year. This increase was primarily due to an increase in SG&A expenses associated with the collaboration agreement with Biogen.

Operating loss on a GAAP basis for the first quarter of 2026 was $8.3 million as compared to an operating loss of $10.3 million for the same quarter last year. The change was primarily due to higher revenues, partially offset by an increase in SG&A expenses associated with the collaboration agreement with Biogen. GAAP net loss was $2.3 million for the first quarter of 2026 or net loss per share of $0.04 compared to GAAP net loss of $11.8 million or $0.21 per diluted share in the same period last year. On a non-GAAP basis, which excludes amortization of intangibles, share-based compensation, contingent consideration and depreciation, adjusted operating earnings for the first quarter of 2026 was $28.7 million compared to $25.9 million in the same quarter of last year.

As of March 31, 2026, the company had approximately $384 million in cash, cash equivalents and marketable securities compared to $309 million as of December 31, 2025. This increase was primarily due to cash generated from operations, the timing of Medicaid payments and the Shunovi-related commercial milestones. The company's balance sheet remains strong with no debt and significant financial flexibility for potential M&A and other growth opportunities.

Now turning to guidance. For full year 2026, the company reiterates its financial guidance for total revenues, combined R&D and SG&A expenses and non-GAAP operating earnings. As such, we expect total revenues to range from $840 million to $870 million, comprised of commercial product revenues and royalty and licensing revenues. For the full year 2026, we expect combined R&D and SG&A expenses to range from $620 million to $650 million. Overall, we expect full year operating earnings in the range of $0 to $30 million. And finally, we expect non-GAAP operating earnings to range from $140 million to $170 million. Please refer to the earnings press release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non-GAAP.

With that, I will now turn the call back over to the operator for Q&A. Operator?

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

Specifically on ONAPGO, it's great to see that you have 2,200 start forms now, up from 1,800 in January. Ultimately, what percentage of those patients or start forms do you think you will be ultimately converted to a paying patient? And can you remind us how many weeks it can take from a start form to a paying patient, how long that could take? Thank you.

Yes. On an average, from the time you get a form until you have a shipment, I mean, you could lose somewhere in the 40% to 45% of these patients in the process for all kind of reasons. Whether it's change in the medical condition of the patient over time, the insurance issue, any of these reasons eventually or just lack of response sometimes because a lot of these forms don't have all the completed information. So, you're calling the patient and trying to get more information from them to be able to process it. Sometimes you just don't call that. 

And then as far as the hearing of time, I mean, it could take several weeks. As we go through this process over time, of course, we're always looking at different bottlenecks and try to streamline and improve the process. But it is several weeks for somebody to have the form submitted until finally they get the product shipped.

And so following up on that, to get to your ONAPGO guidance, the high end of $75 million, mathematically, you're going to be needing more than 700 patients on therapy. So, if I did 2,250% conversion, that would be over 1,000 patients potentially on ONAPGO. So, it looks like you can get there. So, can you remind us how many patients are still on ONAPGO today? And when could you expect most of those kinds of hypothetical patients to get on drug? Should it be within the next 3 to 6 months then?

Yes. I mean the high end of our guidance is the $70 million. You're thinking about it the right way. Yes, I mean, that could translate to somewhere around on an average, about 700 patients that you need to have around 700 patients throughout the whole year, clearly to give you the $70 million in sales. The thing is with the 2,200, you have to remember, that's a number that is launched to date. That is not 2,200 in 2026, obviously, right? So, it will be interesting to see how many we generate this year and how many out of the 20 or whatever is left actually out of the 2,200. If we look at the backlog right now, we are probably somewhere around 570, give or take, patients in the queue versus last time we talked it was around 700. 

So, we are going through the backlog, and we're actually improving as time goes on. We're improving our number of patients that are being processed per week. Remember, I mean, we just restarted the whole machinery, so to speak, or the whole process started middle to end of February, so to speak. So it's taken us March, and we've been very happy with the progress the team has made through March, really getting us to very high levels. As I mentioned in my previous remarks, even exceeding performance metrics, exceeding those that were before the supply constraint. 

So things are really on the uptick. We're pretty happy with the rebound in the business, how we're processing these forms, how many of these forms we're able to translate into real patients and real shipments. But we maintained the guidance, of course, because we would like to see another full quarter. So Q1, as I mentioned in my remarks, was really a partial quarter. It wasn't really a full quarter, right? So let's see a full quarter and how quickly we can go through this backlog. In the first quarter, we only really benefited from March, so to speak. February was very partial, very minimal initiations in January. And therefore, it's not a true reflection of a full quarter with the business rebounding. 

But we're very happy with how things are moving along across several metrics with the demand continuing to be strong, as you pointed out, with the 2,200 forms, but also with the way the team is processing these forms and try to minimize the drop-offs and the losses throughout the process. But we feel still pretty good, obviously, and that's why we didn't change the guidance. So still pretty good about the $45 million to $70 million guidance on.

Our next question comes from the line of David Amsellem from Piper Sandler.

This is Alex on for David. First one, sort of jumping off of the last question regarding the guidance range for ONAPGO and the assumptions to get to the top end of the range and the number of patients. Can you maybe speak to what you're seeing in terms of patient persistence for patients who are getting drug? And then secondly, regarding ZURZUVAE, can you maybe speak to how you're thinking about the growth runway of the product?

Yes. Regarding ZURZUVAE, as I mentioned in my remarks, I mean, really pleased with the performance of the product. If you look at the true fundamental metrics as far as prescriptions, number of prescribers, I mean we're really broadening the prescriber base, and we've been very successful with our partner, Biogen, in doing that. And of course, the prescriptions grew a very healthy 82% in the quarter versus last year. So, as far as penetration, we're still in the real early innings on this product, as we mentioned previous quarters. 

The potential of the product is fairly big. Every year, you have around 500,000 women who experience these symptoms. And as I mentioned again earlier, only 29,000 patients have been treated with ZURZUVAE since launching, and we're into year 3 right now. So, we have a long way to go with ZURZUVAE, and we're very happy with the momentum of the brand. And of course, we also started significant efforts on the DTC side and other programs. So, we have pretty nice expectations of growth from the product. 

Regarding, if I understood your question on ONAPGO, is it really the patient profile and the kind of patients we're getting on ONAPGO. It looks like we're starting to get some feel for who is that patient. We don't have a complete full picture yet because as you would imagine, with a new product, it evolves over time. But some of the early indicators, patients tend to be more on the younger side as far as age and/or the disease, meaning they haven't been diagnosed for a long, long time. They tend to be active. They tend to really be looking for -- specifically from a physician perspective, they're looking for something different than a levodopa/carbidopa. So that's the kind of patient profile that seems to be emerging right now as we speak on the ONAPGO side.

And then what are you seeing in terms of patient persistence for ONAPGO?

Yes. It's a little bit too early for us because we got the disruption in the supply and so forth. And actually, we were pretty happy with the refills and how many patients stayed with us around the time of the supply constraint. So, we do have dropouts that are fairly consistent with the clinical study, maybe a little bit more. So, we're watching it very carefully. Typically, these dropouts occur when you have the titration and how well the titration has happened, because with apomorphine, you have to do titration very slowly, starting with lower doses, you can jump in pretty quickly into high doses on apomorphine. So, depending on how that is happening and how the patient is responding to that, once they go through that titration, typically, they tend to stay with it and be pretty happy and pleased with it. And that's been the experience that historically has been in Europe.

Our next question comes from the line of Kristen Kluska from Cantor.

Congrats on a great start to the calendar year 2026 here. Just on ONAPGO, as we think about the mid-2027 approval, how are you working with your partners out in Europe thinking about what the demand might look like in 2027 onwards to be able to work with them to meet that criteria? And then when we think about the U.S. right now in terms of the patients that are getting on therapy, given that these capacity strains are still there to an extent, are you seeing that physicians are prioritizing certain patients over others, just knowing that they might not be able to get their hands on enough supply for all of the patients they want to treat?

Yes. Regarding the last question, I mean, we haven't detected anything specific because of the previous supply constraint that they're using the product on a different patient or one patient versus another. So we can't clear -- at this point, I can't answer that question specifically. But overall, regarding your other part of the question on the supplier and 2027 demand and so forth, I mean, we do have a plan with our second supplier and also the current supplier, because depending on the timing as to when the second supplier comes in 2027, to meet the demand of 2027, certainly. And that's really how we align all that and lay over the current supply, the second supply, and look at the demand in total and make sure that we are covered from either one of them, and/or both at the same time. 

So the second supplier also, I should say, has multiple of the capacity that the current supplier has. So once the second supplier is online, we will feel pretty good about 2027. And I did mention once earlier, we're even working on another supplier as a backup as well in addition to the second supplier. So we're giving up a lot of the backups from a supply perspective to make sure we meet the demand, not only in 2027, of course, and several years beyond that.

And then on ZURZUVAE, how are you seeing adoption in line with the prescribing? Meaning like are you seeing some patients who are coming back for a second cycle of it? What percent of patients are completing the 14-day treatment course? And I guess I'm just -- what I'm trying to allude to is like how close to the recommendations are you seeing this real-time?

Yes. ZURZUVAE typically, I mean, the people stick with the 14-day therapy. It is a short-term therapy to start with. So, it's unlikely that people are going to quit on it. So -- and especially when they start seeing the benefit early, pretty quickly by day 3. So that obviously even reinforces it and encourages them to finish the 14-day therapy. And with ZURZUVAE, obviously, it's a very different kind of business. You don't have refills. Of course, unless mom gets pregnant again, and it's another year or cycle, so to speak, and she happens to have also PPDs with the second pregnancy. But normally, there is no relapse or anything like that for them to come back and cycle fluid again.

And our next question comes from the line of Vishwas Shah from TD Cowen.

Congrats to you guys on another great quarter. So on Qelbree, what are you seeing in terms of some of the adoption trends right now? You commented on some of the adults trying out Qelbree. And so is that the shift in focus now? Or what do you think will drive growth in adoption through the rest of the year?

Yes. We're actually very excited on Qelbree and what we really saw in the first quarter, and it's a pretty interesting dynamic in a very positive way, specifically in the adult segment of the market. So, there are several things that I would pretty much emphasize on Qelbree. Clearly, the adult growth has now outpaced pediatric growth for a number of quarters, actually. This is not the first quarter it happens. We're very pleased with the fact that the adult continues to grow because it is the biggest segment of the market, naturally, and you want to penetrate that segment as much as possible and be very successful in it for the continued future growth of the product. 

And for example, I'll give you another metric. If you look at new prescriptions in the first quarter of 2026, adults again grew by 27%. This is in new prescriptions, not total prescriptions. And these continue to be strong, also with 16% growth. So, the interesting thing is, I mean, we have been emphasizing adult. We've been putting a little bit more emphasis on adults, especially when we are out of the back-to-school season, because we rotate, of course, the emphasis, and we rotate the resources in the back-to-school season. 

Clearly, we put more of a push on pediatrics, but we don't neglect adults. And then when we are out of the back-to-school season, we try to take advantage of the growth in the adult market because from a market point of view, in the total market, adult also continues to be the fastest segment that is growing. So, we want to take advantage of that as well. So we're pretty pleased with that. And as I mentioned earlier, this is for the first time now, a number of prescribers in the adult population has surpassed our number of prescribers in pediatrics, and really jumped pretty quickly, noticeably in this first quarter. So, we were very pleased to see that. 

Also, from the patient perspective, what's really happening, which we're encouraged about also, is the fact that the patient profile, and you would expect that typically in the brand, as it stays in the market for a while, and now we're into year 6, pretty much in May, we're in year 6 of the brand. The patient profile is broadening. So, it's not anymore some of the early low-hanging fruit that you're getting basically. 

What I mean by that is you're really getting a much broader type of patients into the franchise, and physicians are starting to think of so many different types of patients and needs out there that Qelbree could be the answer for. For example, patients who, of course, are intolerant to stimulants, something interesting emerging is patients are really looking for all-day coverage. And a lot of the adults, we know it as a fact, when they use stimulants, even if they use controlled-release stimulants, so many of them have to supplement at the end of the day with an immediate-release stimulant to give them that full day coverage. 

But with Qelbree, you don't need any of that. You just need to take it once a day, whether at night or in the morning, and it will give you full-day coverage. So, I think physicians, over time, as they have more experience with the product, are finding more ways to use Qelbree as a true solution for a lot of their patients. And then, of course, those who are partial responders to stimulants, I mean, stimulants work, but they don't work for everybody. And sometimes we forget that. And a lot of physicians are using it for those partial responders to stimulants.

And then the complex ADHD. And of course, that comes with time as we generate more data around the product and the potential use of the product with comorbidities and so forth, more and more patients are starting to understand that Qelbree could really play a role with these patients who have that what we call complex ADHD because of the serotonin modulation and the very unique multimodal activity and pharmacodynamic profile of Qelbree. So, a lot of very exciting things continue to happen there and really a lot of momentum in the brand.

And then on ONAPGO, what dynamics are you seeing between patients opting for ONAPGO versus VYALEV? So, what kind of competitive dynamics are you seeing there?

Yes. I mean I mentioned very quickly, I mean, the first cutoff typically is patients who have been on levodopa/carbidopa and the physician may not see any incremental additional benefit for the patient to stay on that drug. And therefore, they could potentially benefit more from something else, a different drug, different mechanism, different molecule, and therefore, they would go and turn to something like ONAPGO. And vice versa, if the physician feels that the patient may still benefit from some levodopa/carbidopa maybe for another year or 2 and then they might consider ONAPGO, so they might go towards something like VYALEV or something else instead of ONAPGO. So that's the first type of thing that obviously a physician is assessing.

And then interesting from our research, it looks like our patient profile tends to be on the younger side, the active side earlier in the disease versus the VYALEV patient tends to be a little bit more on the older side. We're trying to dig into deeper into this to really understand what's behind some of that. Some of the folks who may need and have very difficult time at night, they may choose VYALEV because you have to put VYALEV through the night. With our product, I mean, you get pretty much a similar efficacy on reducing off time, but you don't have to wear it 24 hours. But with VYALEV, you have to wear it 24 hours to give you pretty much similar type of efficacy. So, there are different patients that are emerging that could be really different candidates for either ONAPGO or VYALEV.

Our next question comes from Annabel Samimy from Stifel.

This is Jack on for Annabel. Congrats on the quarter. So, on ZURZUVAE, I know that there the active DTC campaign running right now. Clearly, the product has been doing very well overall. But do you have any additional insights or color on feedback from that and how patients are responding to the DTC campaign compared to maybe a more direct physician recommendation?

Yes. Unfortunately, no, because it's really early to be able to have a good read. I mean we just started it, and you need several months of data to get a meaningful read on a response if you're getting a good response from the DTC. The only thing I can tell you is kind of anecdotal feedback from physicians, from patients who have seen it or I mean they really relate to it. The messages, the communication out of the commercial and so forth, we've received very positive feedback on that. But in the end, it has to turn into prescriptions, of course. I mean that's really the key measure at the end of the day. And it's pretty early for us right now to say anything as far as the impact of the campaign.

But certainly, I mean we -- I mean the effort there is clearly to provide significant education because this is a market that needs a lot of education on the consumer side as well as on the health care provider side. And that's what we are trying to do. We've been building the market, and it takes a while to build the market, and that's something that needs to be -- continue to be invested in. But again, initial signals, which are more anecdotal seems to be positive.

Very helpful. And then just quickly, given your success with that collaboration, is your current M&A appetite kind of more focused on maybe something similar, like a revenue-generating partnership or more on acquisition of wholly-owned late-stage assets? Are there any shifting preferences there? Or are you still kind of agnostic to any option?

Yes. No, I mean our priority is revenue-generating assets that we can wholly own it and obviously build it and grow it from wherever it is at the time we buy it. And then the second priority, if it's not revenue generating, we're looking at assets that are fairly late stage. So, these assets could potentially be launched in like between a year to 3 years from the time we acquired them. So that's really what we're very much focused on and fairly agnostic in the CNS space and of course, women's health as well.

And our next question comes from Chi Fong from Bank of America.

I want to follow up on the bringing the second supplier online for ONAPGO. Could you give a chance to meet with the FDA to get any sort of feedback or alignment on sort of the path of getting the approval? Did any of the feedback help inform the timeline guidance you provided today? What I'm wondering is whether there's any accelerated path like rolling submission relative to your 3Q filing guidance? And I guess on the other side of the things, on approval timeline you guided to by mid-2027. I recall on the last earnings call, you talked about review timeline could be a range somewhere in the 6- to 9-month range. So, I'm curious if you have any better clarity on the review timeline now if you have already met with the FDA? And I have a follow-up after that.

Yes, sure. Yes, the answer is yes. We've been very much in touch with the FDA on an ongoing basis. And yes, the guidance we just gave today has been and is based on the conversations we've had with the FDA. So if we do file, which we said we're expecting to file in the third quarter, we expect the approval, again, consistent with what we said before, it could be 6 months to 9 months. So that will fall at the -- at the upper end of the timeline, 9 months, that means midyear 2027. And if it does take only 6 months for review, that obviously will be within that -- earlier than that. So that's pretty consistent. The FDA was consistent with their feedback with all the discussions we've had with them. So depending on when exactly we file, July, August, September, whatever, and then you add 6 months to it or it could take 9 months, I mean that's really within that frame that we just gave today.

Great. And my follow-up is, obviously, the second supplier already has experience supplying the product in Europe. But given the sometimes-idiosyncratic nature of the agency handing out manufacturing issue citations and the sector more broadly, can you talk about the confidence level of timely clearance of the second supplier?

I mean we have no indication that something could happen that -- that could really derail this timeline from that perspective. I mean, clearly, they have -- once we submit the package, they have to, of course, review the data and so forth. And then they have to also schedule the inspection. And as far as we know, I mean, they have been doing inspections, although it is outside the U.S. and Europe. So, we don't see -- and we're not aware of anything that could hinder that. But that's why we continue to keep the timeline fluid saying 6 to 9 months because of that specifically, but we're not aware of anything that could tell us that this could derail this thing completely and make it not an option for us at all. So, we're pretty confident that we should be able to meet that timeline and secure that second supply.

So I am showing no further questions at this time. I would now like to turn it back over to Peter Vozzo.

Thank you for joining us on this call today. 2026 is off to a great start. We have positive momentum across our business, and we continue to generate strong cash flows beyond the strength of our growth products and through the efficiency of our operations. We look forward to continued strong growth and execution on our growth products throughout the year. Thanks again for joining us this afternoon. We look forward to providing you with updates throughout the year.

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

Okay. Thank you very much. Well, good afternoon, everyone. Thank you for joining us this afternoon. We're obviously excited for our next presentation. We're happy to present Supernus Pharmaceuticals here.

For those of you who don't know me, I'll introduce myself, I'm Glen Santangelo, I'm the analyst at Barclays responsible for the specialty pharmaceutical sector. Amongst other things here joining us from Supernus today is the President and CEO, Jack Khattar, who -- we're very happy to have you here. So thank you very much.

Obviously, a lot to talk about in 2025, as you reposition yourself for 2026. So maybe that's a good thing for us to start and sort of dig in. You can talk about some of the accomplishments in 2025, in particular, the Sage Therapeutics acquisition. In July, you had an FDA approval, new product launches.

So let me let you start there and talk about how things have sort of evolved in 2025 and that set the stage for 2026.

Yes. Sure. And thank you for having me. And just a quick reminder for everybody that I'll be making forward-looking statements. So please refer to our SEC filings for the risk factors.

Yes, I mean 2025 was a remarkable year for us, not only we pretty much completed the transition that we've been going through with the legacy products losing exclusivity, but also having a record year from a revenue perspective and numerous accomplishments, as you mentioned, starting with, of course, the Sage acquisitions and the addition of ZURZUVAE to our product portfolio, it's been a tremendous addition to the portfolio. It's a major and will continue to be a major growth driver for the company. We're just getting started in that space. The product is only a couple of years old.

And then, of course, the approval and the launch of ONAPGO and that launch and the performance of the launch pretty much surprised a lot of folks on the -- in a very positive way. So we're very happy to add that product to our portfolio as well. And clearly, the continued growth with Qelbree and GOCOVRI. So if you look at our product portfolio, 2025 pretty much marked a very important milestone for us. It's a complete makeover of our product portfolio with 4 growth drivers.

Right. When you think about those 4 growth drivers, right, Qelbree, GOCOVRI, ZURZUVAE and ONAPGO. I mean they drove over 20% growth in the fourth quarter, not that we want to focus on the fourth quarter, but it felt like you were exiting the year with a fair amount of momentum sort of setting the stage for 2026.

Is there anything that you saw in the second half of 2025 that maybe surprised you positively? Or maybe anything that was -- maybe could have went a little bit better according to your expectations?

I mean one of the big surprises in 2025 has been on ONAPGO and the incredible performance of the product since we launched it back in April to the point it actually contributed to a hiccup that we had on the supply side. So ONAPGO has been very exciting. It's a growth potential. The demand has been incredible.

And what also surprised us is despite the supply constraint that we had, which we talked about in November, actually physicians, which is a great measure for demand, continued to submit forms -- enrollment forms for patients despite the fact we had the hiccup and the forms grew from 1,300 forms to about 1,800 forms just in that period when we had these constraints.

So the demand continues to be strong. We continue to be in front of these physicians, educating them about ONAPGO because we knew we're going to come back at some point. And now we're very excited that we have a good feel around that issue, a good plan in place for it. as we talked about it in February.

Well, I mean I think what you said that's important is, despite the supply issue, the demand part of the equation was always there, and I think the market kind of recognize that, right? And with the, sort of, reconfiguration of your portfolio in the second half of last year, the stock was up 80%, I think in a 6-month span.

So clearly starting to get a lot of credit for that. So congrats on those accomplishments, so why do we dig into the 4 major products, the main products? And we'll start with Qelbree. Obviously, your biggest asset by a wide margin is ADHD product for those that are less aware.

The scripts were up big again in the fourth quarter, 18%. I think highlighting that demand. Maybe can you elaborate a little bit here on what you think is driving the demand for that product, the competitive landscape around that product and some of your commercialization efforts that may be driving that strong execution?

I mean, right from the beginning, Qelbree has been fundamentally a very different product than what the market has been used to historically, and we've been in the ADHD market for 25 or 30-plus years. We've created 4 different ADHD products historically, starting with Adderall, Intuniv, Mydayis and now Qelbree. So we know the space very well. And for a long time, we've been looking for a nonstimulant that actually works. That simple, a nonstimulant that really works.

And specifically, with the speed of onset, because the existing nonstimulants, specifically Strattera, for example, would take weeks and weeks for it to really kick in and for mom or the parents to really find out whether it's going to work for their child or not. So if you can imagine, a child school is struggling, whether it's grades, socially, suspension letters, all kind of difficulties throughout, I mean, 5, 6, 7, 8 weeks into the school year is like Eternity. So what typically parents will resort to is go back to a stimulant because stimulants work quick, work fast, but they all have their issues, they are controlled substances and not every parent want to put their kids on a controlled substance.

Today, we have an option, which we didn't have that. And that is Qelbree, because Qelbree works as early as week 1, specifically for children. And it may need -- you might need as an adult to titrate up for another week. So within 2 weeks for adults, you can tell whether it works or not. So why on earth would you put your child on a controlled substance, if you have another option that within a week, you can know whether it's going to work for them or not. You can always resort a stimulant, right?

So that has been a great value proposition for a lot of patients out there, whether on the pediatric side or even on the adult side. And that's why we've seen great success with the product over the past 5 years. And as you rightfully pointed out, and even this past quarter, we grew by 18% for the year by 21% in 2025, and that's already year 5, and we're into year 6. And...

Yes. So you're growing 18%, 5 years in?

Yes.

And can you talk about the physician education efforts and you think it's -- your commercialization efforts, do you feel like help us assess sort of the durability of that trend just sort of given your market share and your position in the market?

Yes. I mean, market share in 2025, we did about 931,000 prescriptions. The market itself is 111 million prescriptions. So we haven't even scratched the surface as far as the potential out there.

And clearly, from an effort perspective -- marketing effort perspective, I mean, the product is very well differentiated in the marketplace, and it's a very promotion-sensitive area. So we continue to push through our sales force. And the key recipe for success in this category in any category is very good targeting and frequency that you can get in front of these physicians to change habits because physicians are creatures of habit like we all are. And it takes time and frequency for us to convince them to start with an nonstimulant instead of always start with a stimulant because typically, that's the first line of treatment, it's stimulant before they even consider anything else.

So we're trying to really reverse a lot of practices that have been established for years and years with a completely new paradigm here.

Okay. Can we maybe shift gears and go to GOCOVRI? Your second biggest drug for extended release for Parkinson's double-digit script demand as well here. Can you talk about the differentiation of this product? And sort of your commercialization efforts here and sort of where you think we are in sort of that growth curve?

Yes. I mean, GOCOVRI actually is the only product in the Parkinson's space that is approved for the treatment of OFF episodes and dyskinesia. Most of the products in Parkinson's treat off episodes and that's it, nothing really treats dyskinesia.

So GOCOVRI is the only product approved for that. So it has a very unique positioning. And most people get dyskinesia at some point in the progress during the progress of the disease as they get more and more off episodes over time. They take different medications, dyskinesia is caused by a lot of the medications that these patients are taking. And therefore, there is a great place for a product like GOCOVRI.

GOCOVRI is now about 9 years into the market actually was launched back in 2017, and we were really excited to see last year growing at double digits, 14% in prescriptions, 12% in net sales. So we're very excited about the product and its continued potential. There's a lot of patients out there who could really use that type of product.

And when you think about the -- all right, let's shift gears. Let's go to ZURZUVAE. This is the asset you acquired from the Sage deal. Back us up and what attracted you to this asset in the first place?

Yes. I mean, again, as you see from our portfolio, we're always looking for very unique products. So ZURZUVAE is the only product approved for postpartum depression at this point. And it was the first and only oral treatment for postpartum depression. Until now and recently, most physicians, if they do actually diagnose and treat postpartum depression, they would use SSRIs. And SSRIs haven't been really studied the right way of designed and developed for postpartum depression.

And a lot of -- most of the times, they actually require the patients to wait for weeks for them to kick in. They're not effective from day one. If you look at the ZURZUVAE profile, by day 3, you can start seeing impact on the disease. And you will be done by day 14. It's only a 14-day therapy, and you're done. -- and you rarely need any refills or there is no really -- it doesn't come back as far as the condition itself. So it's a very unique product. It's an asset that has longevity. It's a new chemical entity. It's really a great innovation in the space. And we are in CNS and have been focused on CNS for years. So that's why it was a very important asset for us.

Any LOE concerns across the portfolio?

I mean LOE is the most upcoming potential here will be GOCOVRI, which is like mid-2029. That will be the earliest one in the rest of the portfolio.

And what about Qelbree?

Qelbree is 2035 as the last to expire patent.

All right. And I think in your opening remarks, you sort of talked about maybe ONAPGO as being maybe one of the positive surprises to you in 2025. How strong of the launch you have? Maybe you can just sort of talk about that first half of 2025 launch and sort of what you did in the second half that maybe sort of drove those strong results in that, maybe faster uptake than maybe you expected it?

I mean one of the key assumptions we had assumed initially, because our label says advanced Parkinson's for the treatment of advanced Parkinson's.

We assume that probably initially, at least initially for the first maybe couple of years, we're going to get mainly severe patients who have progressed significantly in the disease. And the only option for them at that time is either deep brain stimulation or another invasive surgery, and therefore, an infusion device would make a lot of sense for these patients. And those would be probably the most suited initially for the product.

Now the product itself has been in Europe for many years and the clinical practice has shifted over the years to start treating actually more moderate more earlier-stage type of patients, but that happened over time. It didn't have it overnight. And that's why when we launched the product and we saw the demand, we're like, whoa, I mean, this is really much obviously, stronger than we expected.

And we were starting to get a point where we truly understand the patient profile and who is getting ONAPGO and who is on ONAPGO and then, of course, we have the supply disruption. So before we know it, we will have a much better handle on that patient profile. And most likely, maybe we are getting patients who are more on the moderate side of it, and that really opens up the whole opportunity.

Can you give us just a little bit of background on the supply disruptions that you disclosed in the fourth quarter. What drove those? What's the status of that? And sort of how we position relative to that for 2026?

Yes. Currently, the product is produced by a third party, and it's not a production line that is dedicated to ONAPGO. There are other clients on that production line. And basically, what we face is that because of our overwhelming demand, and at the same time, the other clients have also additional demands from a capacity perspective, we couldn't get enough capacity and production from the third party.

So through a lot of work and effort and so forth, we were able to finally fight for enough capacity for 2026, which we felt very comfortable with that gives us...

With that supplier?

With that supplier that will support our guidance that we gave in 2026, which is the $45 million to $70 million in sales on ONAPGO.

In parallel, we're working with a second source of supply, and that is our own partner startup in Europe who actually makes the same exact product for the European market. So we will be tapping into that facility. But that facility, we have to make a submission. We have to get it registered by the FDA and approved for providing product into the U.S. market. So we anticipate that second source of supply to come online in 2027.

So that's where we are, and that's why we felt comfortable that we can go back and start initiating patients.

Before we talk about the pipeline, let's just sort of wrap all that together when we talk about the guidance, revenue is $840 million to $870 million, that's 32% to 37% growth. That's big numbers across the portfolio driven by those 4 products. I mean, anything sort of worth calling out within that top line number that maybe people be interested or surprised to hear or will it be balance across the portfolio?

No. I mean, you're going to have balanced contributions from all these 4 products. I mean that's the expectation that we have. I mean, Qelbree is going to -- it is our biggest product, but it's going to continue to contribute very significantly. ONAPGO, of course, I mean, and we communicated what that is $45 million to $70 million on ONAPGO.

ZURZUVAE is going to continue to grow significantly as well. It's only 2 years old as far as the product. I mean we have treated only 20,000 patients every year, we have 500,000 women who suffer from postpartum depression. So there is a huge opportunity for us there. So the contributions are going to come from all the different pieces...

Despite that revenue growth, the operating earnings of $140 million to $170 million, roughly flat year-over-year. Can you put that in context for given the revenue growth?

I mean given that ONAPGO and ZURZUVAE are 2 years or less. I mean, they're still new. We're still investing behind them. Clearly, a lot of the marketing investments, I mean we did communicate that on ZURZUVAE,for example, we have a all new program that didn't exist in '25, which is DTC campaign to provide more education to women and mothers and expectant mothers and so forth because the knowledge and the awareness of postpartum depression is pretty low among consumers.

And they don't really come forward and discuss these conditions with their doctor. And a lot of the symptoms of postpartum depression are typically confused, unfortunately, with fatigue, lack of sleep, additional stress because when a newborn comes to the family, so to speak, everything has disrupted schedules, fatigue, sleep, all that. So people don't realize that actually it could be postpartum depression. It's not necessarily just these kind of symptoms.

And it takes a lot of education to get to women to realize that and mothers and to take the courage and take that first step and discuss that with their OBGYN because there is always also a lot of feelings of shame, guilt attached to that. There is nothing to be ashamed of. These are normal things that could happen and it's not your fault as a patient. That is due to the hormonal changes from pregnancy to delivery. So this is something that does happen and there is treatment for that.

Okay. And what about the uptick in our R&D spending as well. Let's move over to the pipeline because you have two candidates in Phase II and one candidate Phase I. And so I want to give you a couple of minutes to sort of talk about that pipeline and those 3 assets and kind of when we should expect the readouts on those 2 sort of Phase II trials as those could be important catalyst one way or another for the stock.

The 2 key programs, SPN-817, which is for epilepsy, we expect that product to be fairly differentiated from a potency efficacy perspective as well, it has the potential to perhaps help with cognition because it's an acetylcholinesterase inhibitor, which is a very well-known class of drugs for memory, Alzheimer's and so forth. So we expect that to be a differentiation for that product. And it is currently, as you mentioned, enrolling Phase IIb.

Now epilepsy trials tends to be notorious for being slow recruitment wise. So we're not expecting data until '27. And then we just initiated recently the Phase IIb on our SPN-820, which is a first-in-class new chemical entity in depression, and that's an MDD. Now MDD will probably recruit much faster clearly than the epilepsy program. So again, it will be in 2027.

And we'll be a little bit more specific as to when in 2027 as we get at least a quarter or 2 recruitment so we can have a better trajectory on the completion of these studies.

Okay. And then you do have one product in Phase I, which is a stimulant use to treat ADHD. Could you talk about 443? And obviously, we're in the earlier stages, but anything you want to share related to this molecule or...

Yes. I mean it's still early. As we said, this year, we're looking at starting the SAD and MAD study for this year. Last year, we did the first in human, which gave us good tolerability in the safety profile of the molecule. But we look towards this molecule to be a differentiated stimulant with the potency and efficacy of a stimulant, yet potentially not classified as a narcotic as a C2 kind of classification.

So it will be interesting to see the profile as we develop the product and what kind of a package we can come up with it. But it's a fairly differentiated molecule. And that's actually a molecule that came completely out of our own discovery program in R&D.

So elevated spending in 2026 sort of keeps that operating profit roughly flat. I mean I'm not asking you for sort of longer-term guidance, but how should we think about the outlook for profitability sort of longer term? And that pathway to sort of more operating leverage as some of your 4 commercial assets mature and we drive greater revenues and a lot of the physician education were to begins to flatline or gets done or relative to the R&D spending. Help paint us a multiyear picture of that operating profit sort of leverage, if you will.

There's no doubt. I mean, as time goes on, we will gain more operating leverage. That's a given -- we will get to even levels where we used to be at before loss of exclusivities and so forth. As we pass through some of these heavy investment years. And I'll give you a very small example on Qelbree, for example, we don't spend the same marketing budget we used to spend when we first launched the product for second line.

So I mean you kind of taper off some of these investments as time goes on. And we will expect to do the same thing and rationalize the spending and reallocate resources accordingly to the products and their growth profile. So certainly, we will be able to leverage more the infrastructure that we have.

So we're almost coming up on time. So I just have one last question. When you think about, sort of, the transformation or evolution in 2025 in the portfolio and the developments that you made, the stock obviously benefited significantly in the second half of last year. Is there anything that you think may be still underappreciated, misunderstood with the investment community. Any consistent questions you're getting anything sort of worth calling out that you think could be a dislocation relative to what people think versus reality?

I mean, on the commercial side, I think people finally are getting there to where we thought we would be as far as the potential of our portfolio, the growth assets and so forth, I think most people have a good appreciation for that.

The pipeline certainly is still not appreciated, and I understand that because we need to generate more data on both 817, 820. I mean, should the science actually work and our thesis works on 820. That will be another big transformation for Supernus. I mean that product is a huge, huge product as far as differentiation in the depression market.

I mean that potentially could be an oral product, it is an oral product that could work within hours and has a ketamine-like effect without the hallucinations we have, without any clinical supervision, without any of this baggage that you have with some of the other products being developing in that space. So 820 has a very huge potential for really, again, another transformation for Supernus moving forward.

Well, listen, Jack, we're out of time, what I want to do is I want to flip it back to you to sort of give you the last word. I mean, we talked about a lot of the transformation here and a lot of the positives. But is there anything else that we didn't talk about that you want to share with the investor community? Anything else that you think is important related to questions you're getting. I want to give you the last word. Anything else you want to leave or share with today.

Thank you for all your time. I mean, the only thing I would say is we're just starting. It's only the beginning, and we have a clean balance sheet. M&A will continue to be also a key growth strategy for us. We are believers in both M&A as well as R&D because science doesn't always work the way you like it to be. In M&A, you don't always find what you like to find. So you have to employ both strategies for continued future growth.

Okay. Jack Khattar, President and CEO of Supernus Pharmaceuticals. Thank you very much. Great to have you here.

Good afternoon, and welcome to Supernus Pharmaceuticals Fourth Quarter and Full Year 2025 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to hand the conference over to Peter Vozzo of ICR Healthcare, Investor Relations representative for Supernus Pharmaceuticals. You may now begin.

Thank you, Antoine. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals Fourth Quarter and Full Year 2025 Financial Results Conference Call. Today, after the close of market, the company issued a press release announcing these results.

On the call with me today are Supernus' Chief Executive Officer, Jack Khattar, and Chief Financial Officer, Tim Dec. This call is being made available via the Investor Relations section of the company's website at www.ir.supernus.com.

During the course of this call, management may make certain forward-looking statements regarding future events and the company's future performance. These forward-looking statements reflect Supernus' current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the Risk Factors section of the company's latest SEC filings. Actual results may differ materially from those projected in these forward-looking statements.

For the benefit of those of you who may be listening to the replay, this call is being held and recorded on February 24, 2026. Since then, the company may have made additional announcements related to the topics discussed. Please reference the company's most recent press releases and current filings with the SEC. Supernus declines any obligation to update these forward-looking statements, except as required by applicable securities laws.

I'll now turn the call over to Jack.

Thank you, Peter. Supernus had a remarkable 2025 with significant progress made against our strategic objectives. The company achieved record total revenues of $719 million, delivered strong growth of 40% in revenues from our 4 growth products, successfully executed an integrated acquisition of Sage Therapeutics, obtained the FDA approval of ONAPGO and launched ONAPGO in the Parkinson's market.

Our financial performance in 2025 once again underscored our emphasis on growing our core business despite the loss of exclusivity on both Trokendi XR and Oxtellar XR. With our 4 growth products, Qelbree, GOCOVRI, ZURZUVAE and ONAPGO, we have built a solid foundation for a new phase of accelerated growth for Supernus. During the fourth quarter of 2025, revenues from these 4 growth products accounted for approximately 76% of total revenues.

Starting with ONAPGO, during the fourth quarter of 2025, ONAPGO generated net sales of $8.9 million, up from $6.8 million in the third quarter of 2025, and finished its first year on the market with $17.3 million in total net sales. Demand for the product continues to be healthy despite the announced supply constraints with more than 540 prescribers submitting over 1,800 enrollment forms since the launch of the product and through the end of January 2026. We have been focused on resolving the supply constraints that we discussed on our third quarter 2025 earnings call. Progress with the current supplier has been made, allowing us to resume new patient initiation while continuing to service our existing ONAPGO patients with maintenance therapy.

Our current outreach effort of verifying health benefits and coverage includes more than 700 patients whose forms are currently in the queue for processing. In the fourth quarter of 2025, prescriptions grew by 29.6% and the number of prescribers grew by 28% compared to the third quarter of 2025.

Switching now to ZURZUVAE. The brand had strong performance in 2025 with $32.8 million in collaboration revenues in the fourth quarter, and $53 million for the 5-month period since the closing of the Sage acquisition on July 31, 2025. Full fourth quarter 2025 U.S. sales of ZURZUVAE, as reported by Biogen, increased approximately 187% compared to the same period in 2024, and approximately 19% compared to the third quarter of 2025. The number of prescribers in 2025 doubled compared to 2024 with more than 70% being repeat prescribers. Total prescriptions in 2025 increased by more than 150% compared to 2024.

Regarding Qelbree, the product had another year of robust performance with 21% growth in total annual prescriptions in 2025 compared to 2024, and as reported by IQVIA. Qelbree exceeded $300 million in net sales for the year 2025, delivering 26% growth compared to 2024. In 2025, the brand delivered double-digit prescription growth of 29% and 18% in both the adult and pediatric patient populations, respectively. For the fourth quarter of 2025, total prescriptions increased by 18% compared to the same period in 2024, while net sales increased by 9% as net sales were impacted by an annual gross to net deduction. This was due to an unexpected bill of $4 million received from one of the PBMs covering the full year of 2025, and which was fully reflected in the fourth quarter. For full year 2025, gross to net for Qelbree ended up approximately 49%. Our expectation for 2026 continues to be consistent with our previously disclosed target of 50% to 55%.

Switching now to GOCOVRI. For full year 2025, net sales reached $146 million, increasing by 12% compared to 2024, and total annual prescriptions reached an all-time high of approximately 67,000, growing by 14% compared to 2024. The brand finished 2025 with strong prescription growth of 16% in the fourth quarter compared to the same period last year and with net sales of $38.6 million.

Moving on to R&D. We initiated a follow-on Phase IIb randomized, double-blind, placebo-controlled trial with SPN-820 in approximately 200 adults with major depressive disorder. This study will examine the safety and tolerability of SPN-820 and its efficacy at a dose of 2,400 milligram, given intermittently twice per week as an adjunctive treatment to the current baseline antidepressant therapy. Our Phase IIb randomized, double-blind, placebo-controlled study of SPN-817 is ongoing with a targeted enrollment of approximately 258 adult patients with treatment-resistant focal seizures. This trial utilizes 3-milligram and 4-milligram twice daily doses.

And for our SPN-443 program, we expect to initiate a Phase I single ascending and multiple ascending dose study in adult healthy volunteers in the second half of this year. We have completed our evaluation of the early-stage pipeline assets from the Sage acquisition. As a result, we will retain certain assets for internal development, and we will be seeking partnerships for the remaining assets.

Finally, corporate development will continue to be a top priority for us as we look for additional strategic opportunities to further strengthen our future growth and leadership position in CNS through revenue-generating products or late-stage pipeline product candidates.

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

Thank you, Jack. Good afternoon, everyone. As I review our fourth quarter and full year 2025 results, please refer to today's press release that was filed earlier today.

We achieved record total revenue of $211.6 million for the fourth quarter of 2025, an increase of 21% compared to the same quarter last year. Excluding net product sales of Trokendi XR and Oxtellar XR, total revenue for the fourth quarter of 2025 increased 34% compared to the same quarter last year. Total revenue in the fourth quarter of 2025 was comprised of net product sales of $158.1 million, collaboration revenues associated with ZURZUVAE of $32.8 million, and royalty, licensing and other revenues of $20.7 million. This includes $15 million of licensing revenue recognized in the fourth quarter of 2025 related to the achievement of a regulatory milestone under our collaboration agreement with Shionogi. Please note, collaboration revenues represent approximately 50% of the sales of ZURZUVAE reported by Biogen. This increase was primarily due to the increase in net product sales of our growth products, Qelbree and GOCOVRI, as well as the addition of collaboration revenues from ZURZUVAE, and from the launch of ONAPGO in April of 2025.

For the fourth quarter of 2025, combined R&D and SG&A expenses were $150.2 million as compared to $108.1 million for the same quarter last year. Operating loss on a GAAP basis for the fourth quarter of 2025 was $4 million as compared to operating earnings of $21.4 million for the same quarter last year. The change was primarily due to higher Sage operating costs in the fourth quarter of 2025, and incremental intangible asset amortization for ZURZUVAE and ONAPGO.

GAAP net loss was $4.1 million for the fourth quarter of 2025 or a loss of $0.07 per diluted share compared to GAAP net earnings of $15.3 million or $0.27 per diluted share in the same quarter last year. On a non-GAAP basis, which excludes amortization of intangibles, share-based compensation, contingent consideration, depreciation and acquisition-related costs, adjusted operating earnings for the fourth quarter of 2025 was $48.5 million compared to $48.3 million in the same quarter of last year.

Total revenues for the full year 2025 were a record $719 million. Excluding net product sales of Trokendi XR and Oxtellar XR, total revenue for the full year 2025 increased 27% compared to last year. Total revenues were comprised of net product sales of $626.6 million, ZURZUVAE-related collaboration revenues of $53 million, and royalty and licensing and other revenues of $39.4 million, including the aforementioned $15 million of licensing revenue received due to a regulatory milestone.

During 2025, collaboration revenues represented sales reported by Supernus since the close of the Sage acquisition on July 31, 2025. Combined R&D and SG&A expenses for the 12 months ended December 31, 2025, were $591.8 million as compared to $430.4 million last year. The change was primarily due to higher SG&A expenses, including approximately $73 million of acquisition-related costs from the Sage acquisitions and approximately $50 million related to the Sage operating costs recorded since the closing of the acquisition.

Operating loss on a GAAP basis for the full year 2025 was $62.3 million as compared to operating earnings of $81.7 million for 2024. GAAP net loss was $38.6 million for the full year 2025 or a loss of $0.68 per diluted share, compared to GAAP net earnings of $73.9 million or $1.32 per diluted share in 2024. On a GAAP non basis, which again excludes amortization of intangibles, share-based compensation, contingent consideration, depreciation and acquisition-related costs, adjusted operating earnings were $158.7 million compared to $183.7 million for last year.

As of December 31, 2025, the company had approximately $309 million in cash, cash equivalents and marketable securities compared to $454 million as of December 31, 2024. The decrease in our cash was primarily due to the funding of the Sage acquisition, offset by cash generated from operations. The company's balance sheet remains strong with no debt and significant financial flexibility for potential M&A and other growth opportunities.

Now turning to 2026 guidance. For full year 2026, we expect total revenues to range from $840 million to $870 million, comprised of net product sales, ZURZUVAE collaboration revenues and royalty and licensing revenues. Note, total revenue guidance for full year 2026 assumes approximately $45 million to $70 million of net sales from ONAPGO. As Jack mentioned, new patient initiation for ONAPGO begin in the first quarter of this year.

For the full year 2026, we expect combined R&D and SG&A expenses to range from $620 million to $650 million. Overall, we expect full year 2025 (sic) [ 2026 ] operating income loss in the range of breakeven to a loss of $30 million. And finally, we expect non-GAAP operating earnings to range from $140 million to $170 million. Please refer to the earnings press release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non-GAAP.

With that, I will now turn the call back to the operator for Q&A. Operator?

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

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

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

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

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

Our next question comes from David Amsellem from Piper Sandler.

So 2 for me. First on ONAPGO, and I apologize if I missed this. I just want to clarify. So with the additional capacity, how much of underlying demand can you meet? Or maybe ask another way, can you fully clear the backlog, if you will, with the additional capacity that you now have in place? So that's number one.

And then secondly, regarding the R&D organization with the integration of Sage, you mentioned you're taking on some early-stage products. And just wondering out loud, how you're thinking about prioritizing those, especially relative to your legacy pipeline assets and when we might get some updates on what you're going to bring forward into the clinic there?

Yes. Regarding ONAPGO, the current supplier will certainly help us clear the backlog through the continuous supply that we will be able to have throughout 2026 and more than just the backlog, of course, and because we are initiating new patients, not just with the current situation, meaning the 1,800 forms or 700 patients in the process, of course, that number will continue to be refilled during the year as we continue to grow the number of forms and so forth. So we expect the current supplier to be able not only to clear the backlog, but also, of course, continue to provide for whatever needs we have throughout 2026 until we get the second supplier online.

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

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

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

Our next question comes from Stacy Ku from TD Cowen.

Congratulations on an earnings update and the ONAPGO supply update. So first, just as we think about the ONAPGO guidance for the year and the patient demand that clearly all the analysts are trying to triangulate around. Maybe first, could you talk about the learnings on the patient profile since launch? Maybe talk about the frequency of use that you're seeing. What we're trying to understand -- better understand, obviously, there's going to be a range, but how should we be thinking about the potential net pricing for a year of treatment? So that's the first question.

And then when it comes to the resumption of the new patient initiations for ONAPGO, should we be thinking about that 1,800 enrollment forms is reflecting a more limited writing from clinicians despite the supply disruption? Just a bit of a point of clarification for our second question.

And then the third, as we're just, again, trying to understand the enrollment forms, as the sales force is going back to the clinicians and patients, what kind of dynamics are you seeing in terms of ONAPGO demand and switches [indiscernible]. Our understanding is that behind the scenes with commercial reimbursement and infrastructure was kind of continuing even though we didn't know whether there's going to be supply or not. Happy to clarify the first question.

Hopefully, I'll get all of them. I'll start with the first one. As far as the profile of the patient, I mean, these are folks that are advanced in the disease. A lot of the oral medications are not enough anymore. So they continue to have certainly a lot of episodes during the day. And they're not really well controlled with levodopa/carbidopa and with any of the other adjunctive oral therapy that they're taking. And therefore, they would be -- and in the physician's mind, they would be good candidates for subcutaneous continuous infusion for something that is different than levodopa/carbidopa, if that is the case, and that's what the physician is looking for. And therefore, they would choose something like ONAPGO, apomorphine as a molecule, as a drug for that patient.

As far as the potential moving forward and where the net pricing is going to land, I mean, clearly, the product has been on the market a fairly short period of time, only 8 months or 9 months. Certainly, that will, over time, will calibrate depending on what we end up doing, if we do any contracting and so forth. But we talked historically about -- on an average, it's probably $105,000, $100,000 per year on a WAC basis per patient. Now that certainly assumes a certain usage, which we are starting to get a better feel for. I don't have the data as much as I would like to before I say that's exactly how people are using the product and how frequently they're using it. But the $100,000 typically assumes about a cartridge a day, give or take, to get to that price or cost per year -- per patient.

And then the next question, I believe, was basically on the 1,800 forms and so forth. If I really understood the question, I mean, think about it, that's like a funnel, that's like a bucket of all the demand. So that's why we try to give you this number to give you an idea of what the demand is. And then clearly, as we process these forms as eventually as patients get the shipments eventually, you're going to lose some forms or some patients on the way. I mean that's typical in any process or any specialty type of product. Typically, that's what happens. And you could lose certain patients in the process for many different reasons as whether it's incomplete information, you can never finish the form or complete it, you'll be surprised sometimes how many phone calls you have to make, whether to the patient or to the doctor's office to even complete the form so that you can start processing it.

And then when the hub starts processing the form and then doing the adjudication for insurance, reimbursement, you could lose some patients there. And then as time goes on, a patient may change their mind or their situation might change, medical situation. So for all these factors, clearly, the 1,800 don't necessarily end up being 1,800 patients at the end of the day.

And I don't know what was it -- I don't know if there is another question after that.

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

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

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

Seasonality on Qelbree?

Correct, for Q1.

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

Our next question comes from Kristen Kluska from Cantor Fitzgerald.

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

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

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

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

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

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

Our next question comes from Pavan Patel from BoA.

Jack and Tim, so first, congrats on the supply constraint resolution. I think this is a best case scenario. So really happy with you and the patients. I know our own survey work has shown that the demand for this product is really strong among both movement disorder specialists and patients. So my first question is, as you work through initiating these 700 patients out of the queue, should we expect a temporary drag on ONAPGO's gross to net in the first half of 2026? And will a significant portion of these patients require bridge supply or quick start programs while their benefits are being verified?

And then I guess just like a modeling question, can we do more than $70 million with the supply that your current supplier is able to offer you, assuming that state and the second supplier are not online in 2026?

And then just maybe one on ZURZUVAE since I think that's a topic worth hitting as well. I think the 70% repeat prescriber rate is pretty strong. So maybe as you plan your commercial efforts in 2026, are you shifting your focus towards driving deeper penetration volume among those existing repeat prescribers? Or is the priority going to be start -- start being to expand the absolute number of OB/GYNs and psychiatrists writing their first prescription?

Yes. Maybe I'll start with the last question. On ZURZUVAE, clearly, I mean, we are still -- and the way we think about it, we are still launching the product. That's the mindset we always have with new products, clearly, always launching. And as we mentioned earlier, this is a market that hasn't been really prepared a lot before the product was launched because the initial indication was supposed to be MDD instead of PPD. So basically, the product was launched and the market is being built at the same time. So we still have a lot of work to do in building the market, education-wise. The brand actually enjoys a very, very high awareness, but we need to turn that awareness into action. We need to turn that awareness into confidence by physicians and to have the courage to actually screen, diagnose and treat PPD.

So we will continue a lot of the great programs that Biogen and Sage had actually had started way back when they launched the product and into 2025. We will continue a lot of these type of programs into 2026. And actually, this year in 2026, and some people may have already seen the commercial, we have DTC efforts as well to educate as well the consumer and make more and more women and mothers comfortable in talking about their condition and come forward and seek treatment because there is treatment and they can really feel much better after taking a product that is only a 14-day treatment and not waiting too long for it to actually kick in only within day 3.

So a lot of activity behind ZURZUVAE because we're only scratching the surface at this point as far as the potential of this product. I mean, launch to date, we treated around 20,000-plus patients. That's it. And -- as some of you probably recall, every year, you have 500,000 women who actually experience symptoms of PPD and only about half of them get diagnosed and then 60% to 70% of those are treated. So there's a lot of people there who need help and where ZURZUVAE can really help them pretty well.

As far as current prescribers or new prescribers, I mean, like every other product, when it's still early in the launch, you're certainly getting a lot of new prescribers, clearly from a reach perspective. And also as time goes on, you can have more frequency on these physicians. And certainly, those prescribers who are current prescribers, actually, the data shows us that 70% of the prescribers are repeat writers. So clearly, we are getting a lot of business from the current prescribers, that speaks for, of course, also the high satisfaction level with the product and how it's performing. So once the physician actually takes that first step and has the confidence, the conviction and the courage to diagnose and treat. And once they see the results from the first patient, they tend to be repeat writers. And that's really very encouraging for the product at this stage.

Moving on to ONAPGO. I mean, could we do more than $70 million? That is always potential. I mean that is also -- could happen. I don't know right now. But everything we have today, all the information we have as far as demand and everything got us to the point where we believe the range is really $45 million to $70 million. Could it be that we could go above $70 million? I truly don't know right now. Otherwise, we would have had a higher end if we had comfort that we could go above that. So we feel pretty good right now where we stand on ONAPGO and the supply situation, and that's -- so the guidance that we gave is really to help folks to see where the goalposts are on both ends.

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

I'm sorry...

ONAPGO...

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

Our next question comes from Annabel Samimy from Stifel.

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

Yes. Regarding the CNS, the pipeline on 817 and 820, I mean, 820, we just basically initiated the trial. So that's still early as far as enrollment. But you would expect an MDD trial to recruit much quicker than typically an epilepsy trial. So for 820 and 817, both trials, we're looking at data sometime in 2027. It's not going to be this year. Hopefully, as time goes on, we'll have a much better trajectory, specifically on 817 because epilepsy trials tend to be much slower from a recruitment point of view. And also, these are multicenter trials, specifically the one in 817, which is also geographically extends beyond the U.S. So typically, those are also -- could potentially be slower. So -- but data is not going to be any time before 2027. As time goes on, maybe in May or August this year, we'll be able to give you a better feel, is it first half, second half, first quarter, fourth quarter, whatever, we'll update folks as time goes on.

As far as BD, absolutely. I mean, our focus has been CNS will continue to be CNS, and we're agnostic, whether that's neurology or psychiatry. And yes, we did say historically that we are willing to go outside CNS. And obviously, the Sage acquisition in a way, overlapped on both. It is a CNS product, but it got us into women's health. So clearly, that's an area we are looking at right now. And our priorities will continue to be revenue-generating, cash flow generating opportunities. And if there are any assets there that are pipeline assets, our preference would be more on later-stage assets. Again, that could potentially give us new product launches in the '27 to 2030, 2031 time frame. So that's really the prioritization that we have and what we're working towards from that perspective.

And as Tim said, we have a nice clean balance sheet. So we have flexibility on whether the transaction is a product, is it a company? Is it a portfolio of products? So I mean that gives us some flexibility there, obviously.

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

Thank you for joining us on this call today. 2025 was a special year for Supernus. It marked our 20th year anniversary and the completion of our successful transition from our legacy products, Trokendi XR and Oxtellar XR. In 2025, Supernus delivered one of its best performances ever with record revenues of $719 million behind the robust performance of its growth portfolio consisting of Qelbree, GOCOVRI, ZURZUVAE and ONAPGO. Supernus has now a diversified portfolio of growth products where our future success is not solely dependent on one single product. We expect to see continued healthy growth from Qelbree and GOCOVRI, augmented by significant growth from ZURZUVAE and ONAPGO, 2 products that have been on the market for 2 years or less and have a significant market opportunity.

In addition to our 4 growth products, we continue to advance our pipeline and to explore corporate development opportunities to position Supernus as a long-term growth company while generating at the same time, strong cash flows behind the strength of our expanded product portfolio and through the efficiency of our operations.

Thanks again for joining us this afternoon. We look forward to providing you with updates throughout the year.

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

Ladies and gentlemen, the program is about to begin. At this time, it is my pleasure to turn the program over to your host, Pavan Patel.

Great. Thanks. I'll just give a quick introduction, given this is my first time hosting Supernus since I initiated coverage on October 29. I've been working for Jason Gerberry at Bank of America for close to 5 years now, focused on companies like Jazz, Horizon Therapeutics, Teva, Tarsus and United Therapeutics, just to name a few. And I chose Supernus as my first company to cover as lead analyst because I think it's a company that's undergone an impressive transformation to being a diversified CNS growth company. And I think Jack is a solid operator with a strong track record.

With that, I'm joined by Jack Khattar, who is the Founder and CEO of Supernus Pharmaceuticals, and he started this company as a spinout of Shire back in 2005, so 20-year anniversary and turned it into an up to $3 billion enterprise value company and so we can get straight into the Q&A.

So the company most recently did BD deal for the acquisition of Sage. And now that we're a full quarter into the Sage integration, can you provide some more granularity on the realization of the $200 million in annualized synergies? And are these savings coming mostly from SG&A? And have you done the work in order to go through the R&D programs and figure out what's going to be eliminated versus what you're considering continued development?

Yes, sure. And good morning, and thanks for having me. Really appreciate it. And I'll just remind first everyone that I'll be making forward-looking statements. So please check our SEC filings for all the risk factors associated with the business. So yes, I mean, regarding the Sage acquisition, the integration has gone actually very well as well as we expected it, even a little bit better. We're a little bit -- maybe a little bit ahead from tracking the synergies to your question. And actually, in the last quarter, which we talked about in November, you can tell that SG&A, which is related to the Sage acquisition was running about a $14 million, $15 million a month, so to speak. So we really brought it down significantly from the time when Sage was operating on an independent basis. And that is very consistent with what we announced back in August when we closed the deal.

We did say for the rest of 2025, which was at that time, 5 months, about $70 million will be related to the Sage acquisition. So on a monthly basis, it's in the $14 million, $15 million. So yes, by the time we own the business for a full 12 months on an annual run rate, so to speak, in the first year, we should be closing in on the target that we put up for ourselves, which is up to $200 million on an annual basis. And as far as to where these synergies are coming from, I mean, a significant portion is clearly on the R&D side. So from a program perspective, we've really been examining and evaluating the Sage programs before we continue with anything specific or restart any specific program. So we've been going through that process as we speak, and we've made a significant progress. Very exciting early-stage stuff that Sage has done over the years.

So a pretty strong number of molecules, library of molecules, different platforms, some of which have been talked about publicly. Other things that haven't been talked or disclosed publicly. So we're evaluating that within the context of our own discovery. As some of you may know, we've had now for several years, our own discovery program at Supernus. So we're looking now at the whole portfolio holistically regardless where the program is coming from and prioritize where our investment should be in the long term. So that's where we are right now, and we're really very optimistic as to how the integration has been going. The achievement of the synergies as time goes on, clearly have been very, very much in line with what we expected.

And then with regards to the lead asset, ZURZUVAE, I think historically, there might have been sometimes a periodic disconnect between script demand and then the reported revenue due to inventory dynamics. So maybe if you could just help us understand how this evolved in 3Q and how you expect this to evolve moving forward?

Yes. I mean our understanding since we took ownership of the business and a little bit before that, of course, not much as far as like inventory fluctuations that is significant in one way or one direction versus the other. We did notice that in the third quarter, actually IMS or IQVIA restated their numbers. So there must have been some disruption in the trends on the prescription side. I mean this is a specialty, obviously, situation, specialty pharmacy situation. So it's very unlikely that you're going to see specialty pharmacy stocking up unnecessarily unless it's in response to demand because these are high ticket items as far as the drug and so forth. So a lot of the growth -- most of the growth is really demand driven.

And we've been very encouraged in seeing now almost 3 quarters in a row or 4 quarters in a row since fourth quarter 2024, see sequential growth of about 19%, 20% growth in the business that is very healthy. Some of that growth is really due also to the fact that we've expanded the sales force ourselves as well as our partner, Biogen. So that expansion happened in the fourth quarter of last year into the first quarter of this year. So now you're starting to see the benefit of that expansion and really getting real demand growth behind the business. So all in all, a very strong start for the product, a very young product. I mean it's only been a couple of years into it. So it's certainly a very young product.

I haven't really scratched the surface as far as the demand because you're looking at about 500,000 women every year experiencing symptoms of postpartum. And only maybe, maybe half of them or 45% to 50% get diagnosed and somewhere in the 60% to 70% get treated. So there's a lot there to be done from an education perspective, both to the patients, women overall as well as physicians, specifically OB/GYNs in allowing them and helping them screen for the disease, diagnose it and be comfortable in treating something like depression, which is something, of course, they're not trained to, right? As an OB/GYN, you're not necessarily trained to treat depression, but this is something you encounter and are encountering on a day-to-day basis. So we try to give you the ammunition, the tools to be able to assess, screen and diagnose and eventually treat that condition.

And then I guess like just on the point about the upsizing of the sales force, can you help us understand the magnitude of that? And how you see that in a steady state scenario? And then what specialties are these sales reps targeting? Is it just the OB/GYNs? Or are there other sort of specialties that are new sources of patient adds?

Yes. The size of the sales force hasn't been disclosed publicly by Sage or Biogen. So I'll keep that for now as is. But I mean, this is a specialty area. So you have 20,000, 22,000 OB/GYNs. So it's not like it's significantly a huge sales force, so to speak, it's in line with what you would expect a specialty sales force to be in. Given the most recent expansion clearly that I just talked about, I mean, typically, the way we do it, and this is something, of course, that will be discussed with Biogen as time goes on, whether there is a need for further expansion or not. Typically, at Supernus, what we do is more like a stepwise approach.

We don't jump in, throw hundreds of people at a situation and hope it pays out from an investment perspective. So we clearly like to see repay, return on at least the current expansion and see how that is and be able to measure it well through very well-established metrics. And then that should allow us to have a much more informed decision on whether to expand any further in that space. As far as targeting and the physician audience we're reaching, majority of it is OB/GYNs. And if you look at ZURZUVAE's prescriptions today, since launch, it's been mainly in the OB/GYN space coming from OB/GYNs, about 80%, give or take, of these prescriptions are coming from that physician audience.

The remaining 20% is from psychiatrists. So it typically depends on, of course, the patient, how they come into the equation, so to speak. Are they being referred to a psychiatrist or are they being referred to an OB/GYN or they are picked up by the OB/GYN through the screening and the diagnosis done by the OB/GYN. But that's where the landscape is at this point.

And then I guess you mentioned that it's mostly demand driven. So in terms of the gross to net adjustments, should we expect that to be steady from here? Or are you expecting them to evolve as payer coverage expands? Or is payer coverage already at a steady state level and it should be just steady from here?

I mean a significant portion of driving the demand will continue to be building the market. I mean we are building the market at the same time launching this product. There's a lot of market building that is happening and will continue to happen because awareness around the disease, education around the disease is not really that well spread out and well understood. And I'm talking about even women patients themselves. Actually, about 80% of women who are diagnosed by postpartum is the first time ever they've even heard about it. They've never heard about the condition before that.

So there is a lot of education that has to occur among women and clearly then among the physicians who are going to encounter that conditions and how to look for it and how to screen for it, diagnose it, treat it and so forth. So a lot of the demand is going to be driven by grassroot activities, building the market and growing that demand throughout. So again, back to my previous point, I mean, 500,000 women every year experience this condition. The product hasn't even scratched the surface as far as getting penetration into that market, and we're still really in the very early, early innings on this product.

And so like of that 500,000 women per year who have PPD symptoms, like what percent would you say are currently diagnosed? And what do you see that -- how do you see that diagnosis rate improving over the next 12 to 18 months?

Yes. I mean diagnosis is estimated in the 45% to 50%. It fluctuates, of course, every time we look at it, but it's in that range as far as diagnosis and then treatment is more close to the 70%, 60%, 70%. So there is still a lot to be done to really raise awareness, education and then, of course, diagnosing these patients.

Okay. Great. Maybe we can switch over to Qelbree next, which is the largest asset for the company by revenue. And so I guess just going through the last 3Q results, I'm wondering how did the pediatric segment perform relative to the adult segment? I know the adult segment sort of framed as more of the untapped opportunity, right? So just wondering how we should think about that?

Yes. We -- I mean, we continue to grow very well in both segments. So back in '21, we first launched the pediatric indication and then a year later, we launched the adult indication. But the growth in pediatric continues to be very strong. And in the last back-to-school season, as we discussed at our earnings call, we grew by about 19% from a prescription perspective, very robust growth. On the adult segment, although most of the emphasis and the inertia and the momentum has been in the back-to-school on the pediatric side, naturally because of that importance of that season for the ADHD market, despite that, we still continue to grow in the adult, and we grew by 32%. So growth continues to be very healthy and robust in both segments.

And we foresee that in the future as well because overall, when you look at Qelbree, based on the last month, for example, we had a high of 86,000 prescriptions in the most recent month from an IQVIA perspective. I mean we're annualizing at 1 million -- a little bit north of 1 million prescriptions a year. And this is a market that has 103 million or 105 million prescriptions a year. So we still have a long way to go as far as penetration of this market. And the market itself also continues to grow. So back to the back-to-school season. In Q3, the market itself on its own grew by 12% in prescriptions and has been on an annual basis year-to-date, it's around 9%. So very healthy growth even in the market.

And a lot of the growth is being fueled by the growth in the adult segment because historically, the pediatric segment enjoyed a very high level of diagnosis and treatment because we typically can diagnose a child or observe a child in school, at home. There are different areas where a child can be identified that they need help and so forth, not so much on the adult side. So over the years, the adult segment is trying to catch up, so to speak, as far as level of diagnosis and treatment. And a lot of the growth has been fueled by the growth in the adult segment. And more and more adults, celebrities and so forth, people are much more comfortable now talking about mental health in general and talking about ADHD and what they struggle with throughout their day. And the more people are outspoken, people relate to that, more people are coming forward looking for alternative treatments.

So just on this topic of growth drivers for Qelbree, maybe with the genericization of Vyvanse and ongoing shortages of various stimulants, have you seen an acceleration in switching to Qelbree? And is that still a tailwind to the business?

Yes. I mean the shortages in the stimulants, which we've seen now for a couple of years or more than a couple of years, actually, right after the COVID situation, doesn't necessarily help Qelbree, so to speak, unless it really persists and persists for a long time. And the reason I say that is if a physician makes a clinical medical decision that a patient needs a stimulant, they're not going to change the treatment just because the patient couldn't find that specific stimulant. There are a lot of formulations of different stimulants out there, a lot of amphetamine-based formulations, methylphenidate and so forth, right? So more likely, they will go to another stimulant, at least initially to get their prescription instead of completely switching the treatment paradigm from a stimulant to a nonstimulant just because of that shortage.

So some brands actually in the stimulant market have benefited from some of these shortages, but not so much Qelbree per se. Now if the patient continues to hit a dead end, so to speak, in different stimulants are not able to get it and have that issue every once in a while, maybe a physician might reconsider at that time, look, let's -- maybe it's time for us to look for something else. But that's typically the dynamic that we have seen and that we would expect to continue if these shortages continue. Now this is -- the situation has tempered down a little bit. So they're not as severe as they used to be, some of these shortages. So the situation has resolved itself in a way.

And then I guess like in terms of the current source of business in terms of switch patients versus treatment-naive patients for Qelbree, what's the mix for that look like? And has that shifted in the past quarter at all?

Yes. It's been fairly stable. I mean, it ramped up, obviously, from the time we launched, but we are and have been around the 30%, 35% is actually first-line treatment naive patients, which has been very encouraging versus what a lot of people expected initially when we first launched the product. They didn't know what to expect. So Qelbree has been able to establish itself as a first-line treatment for a good portion of the patients. The other 70%, 65%, 70% come from either an add-on or switches. And the majority of the switches right now, about half of them are coming from atomoxetine, which is Strattera and then a good portion from stimulants and the 30-plus percent from stimulants, which is very encouraging because a lot of people for a long time thought that Qelbree will only compete in the nonstimulant segment, and that has not been the case.

We've been able to bring in a lot of stimulant users who are dissatisfied with existing stimulant products for one reason or another. I mean, efficacy, people forget not all stimulants work for all patients. Also a lot of, of course, issues with the stimulants on the side effects side and so forth. So a lot of these dissatisfied patients have considered and continue to consider other options such as Qelbree, and we continue to see that. I mean there is a very healthy source of business coming from the stimulant side that is feeding into the Qelbree patient population.

I guess like in terms of -- if you were to break down the 2 patient categories as nonstimulants and stimulants, like what are the key reasons that patients on other nonstimulants might switch over to Qelbree? And then the same question for stimulants. I guess like some of the feedback that we've gotten from KOLs is like the adults, they'll go on these stimulants because they need more higher efficacy benefit, but then they get that afternoon crash, right? And then for nonstimulants, I guess just if you could frame what the key differentiation is relative to other nonstimulants, which I guess the nonstimulant share of the market is small. So it's sort of an opportunity for them to grow the pie, but maybe there is also some share gains from switches from other nonstimulants too. So...

Yes, sure. The dynamics actually differ a little bit between a pediatric patient and adult patient. As you rightfully pointed out, there are specific reasons why a parent would put a child on a nonstimulant. One of the obvious ones, of course, they don't want to put them on controlled substances and the use potential, all these issues, side effects and so forth. And therefore, you do see, of course, more nonstimulant usage within the pediatric population than within the adult population. And one of the big issues have been, and that's why the market is 90% stimulant and has been for a long time, not because people want to use stimulants all the time and love them, of course, some adults do for other reasons.

It's because the current existing older nonstimulants didn't work. And that's why we always say Qelbree, it's very simple about Qelbree. It's a nonstimulant that really works. And what we mean by that is it works as early as week 1. So as a parent, you don't have to wait as you used to with Strattera 2, 3, 4, 5, even we hear up to 8, 9 weeks into the school year to find out whether the product actually would work for your child or not. I mean that to me as a parent is like eternity into the school year struggling with suspension letters, bad report cards, issues from a social perspective where my kid is isolated, nobody want to socialize, be their friends and so disruptive in class, all that. That's like eternally.

And therefore, as a parent, as much as I don't like it, I'll call up the physician and say, "You know what, I just can't take this anymore." I can't see my child struggling and continue to struggle, put them on Adderall or put them on a stimulant, right? And that's why the market has been skewed so heavily towards stimulants because the current older nonstimulants don't really work and work that fast. With Qelbree, it's a very different situation. As early as week 1, you'll know whether it's going to start working for your child or not. And most likely, it does because we've seen that clinically. We've seen it in the clinical studies, but also in the marketplace now for the last 4, 5 years we've been in the market.

Now for adults, as you said, they have a longer day. They like their stimulants and also -- but they have in the afternoon, they have that crash perspective, and they tend to supplement with an immediate release stimulant to finish up their day. And a lot of them like the feeling on the immediate release stimulant, whether it gives them a nice high, buzz, whatever, they just like that adults. And therefore, when they are struggling with their stimulants, let's say, side effects or they're not still getting the efficacy they're looking for, what physicians tend to do is reduce the dose of the stimulant over time. So they don't have a withdrawal issue with adults.

And also, they don't want to, in a way, upset their patients by taking them off the stimulants completely because patients like it. So they reduce the dose like from 50 to 40 milligram, 30 milligram, 20 and so forth and over time, take them out of the stimulant and in the meantime, adding Qelbree over time, titrating up with Qelbree. So we do see, for example, within the adult patient population, a lot of use is a combination use of Qelbree being added to the stimulant and then eventually, the stimulant taken off the equation completely and the patient stays on Qelbree.

And what many patients are finding out actually with Qelbree, I get a 24-hour coverage. I don't need to supplement later in my day as I used to with the stimulants because my stimulant controlled release stimulant only lasts me 12 hours or 14 hours, which is not enough for my full day of activity. Qelbree gives you a true 24-hour coverage. So now I'm down to only one medication with Qelbree, and I'm able to conduct my business without having to supplement later with another drug. So a lot of the usage there is in combination with Qelbree and with the stimulant.

Great. Maybe we can shift to ONAPGO and GOCOVRI next. So I think this is one of the key focus areas for investors, right, because this is a high-growth asset. And so with regards to supply, I think your commentary at recent broker conferences has been that the supplier, which is used by STADA has dedicated capacity for fill/finish for another product, right, which limits ONAPGO supply. So maybe can you, one, help us understand the decision-making process from the supplier here? And then I have a follow-up to that as well.

Yes. I mean where we have been and where we are is that we have a current supplier, which is a third party. And the production line is not fully dedicated to ONAPGO, so there are other clients on that production line. So capacity has been an issue from that perspective. And of course, our demand has been much higher than expected as well. So we've been, of course, pushing to get as many batches as possible from that production line. Now at the same time, in line with -- in parallel with that, we're exploring also alternative supplier, which is actually our own current partner who markets the product in Europe and has been marketing the product in Europe for many, many years. They have their own production facility.

So we're exploring that facility potentially to also produce ONAPGO. It's exact same product, same cartridge that is being done for the European market. So we have a couple of work streams in parallel that are happening at the same time to make sure we can come back on track and we can restart the process of initiating new patients as soon as possible. So we're very focused on both, getting as much supply as possible from the current supplier, clearly to continue to serve our current patients, of course, and be able to get back on adding new patients, while at the same time, exploring another supplier that could be registered through the FDA and get them online to give us. And that second supplier, our own partner has a lot of capacity. So from a long-term perspective, that would be a great solution anyway that we need. So we have a little bit more assurance and we're not at the mercy of fluctuations from a capacity because of the third-party situation.

Yes. So I guess just a 2-part follow-up. So first, I guess, when I was looking through the EU regulatory filings, I noticed that the contract manufacturer there was Laboratoire Aguettant. So I'm just wondering whether that's the EU manufacturer that's used in the apomorphine that's marketed in the EU historically? And if that's sort of the opportunity with the second supplier? And then the second part of the question is what's the time line for filing a prior approval supplement? Has that already been done? And what's the progress in terms of certifying an additional manufacturing facility?

Yes. I mean, no, I'm not familiar with that CMO. So it's not the CMO we're talking about, the name you mentioned. And as far as time line specifically as to when and how quickly we can bring in that second supplier, I mean, typically, on the normal traditional time lines, it could take you up to a year actually to file, produce a few batches, create the data, make a submission to the FDA, give the FDA the chance to go and inspect the facility and approve the use of that supplier. Now having said that, we're exploring with the FDA any other ways potentially we could expedite that process given the shortage situation we're in and the importance of not, of course, disrupting patients on therapy who are already on therapy on apomorphine.

So we're clearly exploring different alternatives, different angles coming at it from different angles, so we can expedite the process, both with the current supplier, as I mentioned, but also with the new supplier that we can shorten that time line. Absolutely, that's what we're doing and trying to do, I should say. So that remains to be seen as we continue our discussions with the FDA. But clearly, there will have to be certain submission, potentially inspection by the FDA of that facility. I mean that facility produces according to European standards and so forth.

And sometimes FDA may accept interchangeable inspection, whatever. So I mean, there are different ways we're exploring what can be done here to get the product as soon because it's exactly the same product. It's the exact same product that is produced in Europe as the product we have here in the U.S. It's just that has to be released according to U.S. specifications instead of European specifications. And the FDA has to be comfortable with the facility at which it is being produced.

And so the current manufacturing facility that's U.S.-based. Is that correct?

No, it is in Europe. So the facility is a European facility. So from a timing point of view, I mean, I wish I know today. It's a fluid situation as we continue to have multiple discussions, not just with the FDA, but also with the suppliers, as you might imagine. So definitely, by February, when we give like year-end results, guidance into 2026, explain to people what the guidance means, what does it mean to ONAPGO, all that clearly will give more clarity and should be able to give more clarity by then as we get more information about both approaches in parallel as they are occurring at the same time. If we get information before that, that is meaningful, material, of course, we will communicate that before that.

Great. That's super helpful. So now that ONAPGO has been on the market for a few months, can you share any details regarding the discontinuation rate?

It's fairly consistent with the clinical studies. So we haven't seen anything that is unusual one way or the other. So it's been very consistent with the clinical experience that we've seen in the study. So nothing really different there.

And then are there any patients that are on the waiting, which I think like was 1,300 right at the 3Q results who have decided to then go on to VYALEV instead? And is this a dynamic that you're tracking?

Yes. I mean that is a little difficult to track and find out. I mean we certainly have a lot of forms that have been submitted and actually physicians continue to submit forms interestingly. So we have a lot of forms. We have a lot of things that have been processed. We have patients that are waiting to be initiated, but it will be hard for us to really tell whether a patient have decided to stop waiting and they're not patient enough anymore and they want to go to a different alternative. That I truly don't know, and it's hard to track that unless you go back to these patients and ask them whether they're still waiting or not, which is not something.

But once we go back on track and able to initiate that, these patients, obviously, we will find out at that time whether some of these patients have fallen off or completely went on to another alternative. The great news so far, I mean, since we've disclosed all this, of course, and communicated to physicians, I mean, physicians have been great. They've been very supportive. They understand. Of course, we're all disappointed with the situation, so to speak. But they're like, look, we appreciate the transparency. We appreciate what Supernus is really doing here, putting patients first, taking care of their current patients, we get it. We're here for you when you come back and tell us you have enough inventory. We need this product. This is an alternative treatment. It's not available anywhere else, so to speak.

Yes, there are other pump or other alternatives, but ONAPGO is not a levodopa-based product, and we need something else. So we need something different to treat the patients. So we'll be here when you come back and we'll be very supportive. So -- and that's why we've been very careful as to when we come back and what we communicate when we come back. We want to make sure we have the full confidence. When we tell physicians, okay, we're back to normal, let's start putting as many patients as possible. We need to have assurance that will be it, and we don't have another hiccup on the supply side. So that's why we're taking our time being a little bit patient with it to make sure we have as much confidence as possible with any time line we may end up communicating eventually.

And then when you have the inventory on hand, I think the period of time that it was good for, I think, for the label is like 12 months, right? And then in the EU version, I think the product is -- inventory is good for 24 months. So is this potentially a change to the label that you might explore to have the inventory be good for a longer period of time so that you can maybe stockpile more inventory in the future when the supply constraint is resolved? Or how should we think about further down the line remediations of supply chain resiliency?

Yes. I mean, typically, and that happens with all of our products. You start with a certain expiration date and as you collect data, and we continue to collect data on all our products. We continue to extend or expand the expiration dating. So that's normal that will happen with every product we have, and that's an effort we always have there to give us a lot of more flexibility from a supply chain perspective to give us more -- the ability to have safety stock that doesn't expire on you. Now with ONAPGO, we haven't had the issue of inventory sitting around because the demand has been so high. We expect it, hopefully, as we come back, we will continue to be high. So the risk of having products sitting in the warehouse and expiring is probably very low. And -- but it doesn't mean in parallel, of course, to your point, we will continue to work on extending the dating if we can.

And then I think you alluded to this earlier that enrollment forms continue to be added. So maybe if you can just speak to the volume of those enrollment adds, enrollment form adds. Is the level of demand continuing to be maybe not as high as before, but meaningful so that there is sort of a patient bolus that's still available when you resolve the supply constraint?

Yes. I mean it's certainly not at the same rate as it used to be from before, as you would expect. Some physicians may just wait a little bit and say, okay, let me see where the situation goes and then I'll see whether I keep adding. But other physicians continue to put in the forms and put patients' name in the queue because they also know that it will take some time to adjudicate these forms and get them to a point where we are ready to initiate that patient. Sometimes it takes several weeks to get to that point. And therefore, they may still feel comfortable submitting these, hoping, of course, we will resolve the situation in weeks rather than in a lot of months. So it is happening.

But yes, to your point, yes, it is at a lower rate than it was initially. And the answer is yes, as far as patients who are waiting to be initiated, yes, I mean, once we come back, and we'll have to work at that situation to make sure it's very well managed. We will have a big push, a big bolus of patients who will be initiated because of the queue and the backup and the backlog that we have built over the last month or so. So clearly, that is happening right now where a lot of patients and it's adding by the day, so to speak, are waiting to be initiated. So once we go back, we do expect to have a big push as far as initiating new patients.

And then in terms of like the reimbursement, so the patients that were on the drug at 3Q, I think it was 400 patients. What percent of those were on paid drug versus free drug? And should we expect revenue recognition per patient to improve over time? Maybe this speaks to the evolving payer coverage of ONAPGO, whether there's still work to be done there?

I mean we've actually had a fairly good reasonable situation from the beginning at launch. We have coverage and we're able to get coverage on the commercial side and Medicare. So we haven't any significant hurdles in getting the coverage for our patients. So that has been fairly smooth. Of course, that is something you always work on and continue to improve as time goes on. But we haven't had any significant hurdles on that aspect.

And then on GOCOVRI, I think this product continued to grow right in 3Q despite generic entrants maybe for other amantadine products. So what's driving this durability? Is it the dyskinesia indication? Or is it broader use in the OFF episodes?

Yes. I mean, GOCOVRI, I mean, dyskinesia has been a major differentiator. Of course, for GOCOVRI, it's the only product approved for both dyskinesia and OFF episodes. So more and more physicians are realizing they don't have necessarily to lower the dose of levodopa to get rid of dyskinesia or avoid it, so to speak. They can continue to benefit from the levodopa dose and so forth and don't have to lower it and just add GOCOVRI. And if anything, not only it helps them with the dyskinesia, but also it even helps them further with the OFF episodes because even GOCOVRI itself treats OFF episodes as well. So more and more physicians are realizing that.

And obviously, it's been an educational process because it's a paradigm shift in treating because physicians for so many years have been used to and have been trained. You keep raising the levodopa dose over time, you hit dyskinesia, you start lowering the dose. And then you start adding all these other oral medications and so forth and some of which even cause more dyskinesia. And we are like, doc, you don't have to do this. You can stick with the levodopa dose that you're at. You don't have to lower it. You can always look at adding GOCOVRI to help you with the dyskinesia. So it's been an ongoing process education-wise to really get more and more adoption of the product. And the product benefited as we talked about it in the last couple of quarters from the Medicare design.

More and more patients have been hitting the low co-pay much earlier in the year versus later in the year. So that allowed us through the year to really keep more and more of our patients instead of losing them as we typically used to. So that has helped a lot of patients to stay on GOCOVRI. And a lot of our patients have a co-pay of like $25 or less so -- and more of those have been able to get to that level earlier because of the Medicare redesign. So it's been really a great story that way, and we're monitoring it very closely to see how sustainable it is. And hopefully, it is that way.

Yes. Maybe we could shift to the pipeline in the last few minutes that we have here. So thinking on SPN-820, I think you've had mixed results in TRD and you've initiated a study in MDD. Maybe if you can speak to what gives you confidence in the mechanism of action for the broader MDD population.

Yes. I mean on 820, we've had 3 studies. The first one, which was a Phase Ib that was done by the Navitor, early proof of concept. There was one single dose of 2,400 milligrams, and they measured efficacy as early as 2 hours, 4 hours and then up to 72 hours. And the drug separated from the placebo even on the HAM-D6 back then, the smallest study that was. Then we did an open-label study in MDD, mimicking pretty much that dose, but repeated the dose, not just one single study dose, but repeated dose up to day 10, and we saw very similar efficacy actually on MADRS, very significant. Now it's open label. Of course, the big caveat is an open-label study.

At the same time, we had a Phase IIb study in TRD, but the dosing regimen was 1,600 milligram every single day. So that failed. So we think it's all related to the dosing and the regimen that you're giving this product at, and we think this is a mechanism of action that you don't have to hit it every single day. So this is a target in CNS. And as other targets have been shown and more evidence have been emerging very recently that not every target in CNS, you have to engage every single day with a dose. And mTORC1 activation, we think you can hit it with one single dose, such as the 2,400 milligram and you allow the system to actually benefit from that dose and let it reset for 48 more hours and so forth and then hit it with a dose.

So an intermittent dosing of 2,400 milligram, which is the newly designed Phase IIb study, which we are about to start before year-end. We think that has a great shot as answering that question. And it will duplicate actually what we've seen in the open label. I mean we've seen that dose and that dosing regimen work in the open label. Again, yes, it's open label, but at least we have some data that shows us this is probably the way to go with this drug and the way the mTORC1 activation works in the body from a biological perspective. And there are drugs like this. I mean, they are very well established like ketamine, psychedelics and so forth. I mean you don't have to hit the system every single day with a single dose.

Okay. That's super helpful. And then moving to SPN-817, which I think will be the last question given we're coming up at time. You mentioned some open-label data for SPN-817 in the past as well. So maybe if you could provide some more color on the safety profile of this asset, particularly the adverse events that maybe you've seen in the maintenance phase.

Yes. I mean with 817, given the mechanism wasn't unexpected, clearly the cholinergic side effects, specifically the nausea, the vomiting, some of the GI side effects. So we expected that. And we actually -- in the open label, we did instruct physicians to use antiemetics, but they didn't follow instructions as well as they should have or sometimes they did give an antiemetic, but it was a little bit too late. Patients already have either experienced nausea and dropped out. And that's why in the titration phase, we saw a high discontinuation rate of about 27%, if I'm not mistaken. But that discontinuation went down to around 7% or 9% in the maintenance.

So once a patient can go over the hump from a titration perspective and get to maintenance, we saw them they can build the tolerance and they can stay with the drug. So what we're doing right now in the Phase IIb study that is going on, we are -- it's not by choice, but it's obligatory to use antiemetic with the medication. So we are telling physicians, it's not really a choice here. You have to use an antiemetic in the Phase IIb study. We're also exploring other mitigation strategies from a formulation perspective on the drug. So we will input that and amend the protocol on the Phase IIb as we learn from these other mitigation strategies as time goes on.

But I mean, the product works really well. We've seen that in the open label, but also we've seen it from patients who have been on the drug for more than just 1 year. So it's not a placebo effect, obviously. And also, it has a huge differentiation potential here because of the acetylcholinesterase inhibitor as a mechanism of action, the procognitive -- potential procognitive benefits here could be very important. As we all know, for epileptic patients, cognitive decline is one of the big issues they deal with. And if we can have a drug that not only is potent, but also can give you some procognitive benefits, that will be a huge win potentially for patients.

Great. Thank you so much for the time today. I really appreciate it.

Thank you.

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" Jefferies LLC, Research Division

" Stifel, Nicolaus & Company, Incorporated, Research Division

" Piper Sandler & Co., Research Division

" BofA Securities, Research Division

" TD Cowen, Research Division

Good afternoon, and welcome to the Supernus Pharmaceuticals Third Quarter 2025 Financial Results Conference Call. [Operator Instructions] 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 4 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 4 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 ACO. 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 2 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. 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 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 third quarter 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 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 milligram 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 2 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 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 9 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 9 months ended September 30, 2025, increased 25% compared to the same period last year. Combined R&D and SG&A expenses for the 9 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 includes 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 9 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 9 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 9 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. Operator?

[Operator Instructions] 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. 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. 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 2 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 -- 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.

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 -- 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 on NONAPGO built into the annual guidance? And 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.

Nice quarter. Congrats on the nice quarter. Some follow-ups on an 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, ZURZUVAE was approved ahead of Onapgo. But just given this really high patient demand and it 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 third, maybe just off topic from ANOPKo.be 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.

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, sure. Yes, 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.

Our next question comes from David Amsellem from Piper Sandler.

So I have Onapgo question and then also a Zurzuvae question. So on Onapgo, just coming back to the previous questions about potential lost business to a competitor. Have you -- 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, can you tell us how many reps you have detailing the product, your plans for sales force expansion? And also the -- 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?

Yes. Starting with on 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 a 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. I mean, the patients who are on Onapgo, the experience we've seen in Europe for more than 2 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, OB/GYN. So you could, in a way, guess how big the sales force. It can be -- obviously, there's a limited number of OB/GYNs you can go after in the U.S. And 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 type 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. It 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't give you a definite answer clearly that we will definitely get it or not. So -- but I mean, we -- this product is a great product and the potential. The 50% on its own is a great opportunity for us. The 100%, yes, will be a bigger opportunity. That's for sure.

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, sure. Regarding the price, I mean, all I can tell you at this point because obviously, this is -- 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 WACC basis, we expect the annual cost for a patient is probably going to be around $105,000, $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.

On 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. And we're very open to rare diseases as well because, again, from a patient support, we have a great infrastructure around the Parkinson's 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 yes, 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. But with time and diligence, we'll probably be able to find something only time will tell clearly.

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, sure. And I looked at what AbbVie mentioned at their earnings call. And 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 is it being 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.

And as I mentioned earlier, I mean, apomorphine is apomorphine, and it has incredible characteristics from a mechanistic perspective, how it works -- it'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, has -- structurally, it's very similar to dopamine. I mean, that's really a great molecule. And 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. And 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... Our next question comes from Annabel Samimy from Stifel.

Good quarter. Just going back to Onapgo and the reception to it, physicians are clearly interested in the apomorphine molecule 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 inpatient 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?

Yes. 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 -- there are 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 are getting on -- 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. And they have gotten or some of the forms are on patients from APOKYN. So we -- yes, the answer is yes. It's not a huge portion. It's -- we estimate it somewhere in the 15%, 17% is coming from APOKYN. So yes, these patients would be -- would have had exposure on apomorphine, either 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 3 injections a day or 4 injections a day, they may choose to put a pump instead of doing multiple injections a day. So -- and that portion of the business, we always estimated it's probably in the 15% domain.

Okay. 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 they're mostly focused on the type of molecule that they want to move forward with as far as 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. And 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. 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 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. And then just one other question going back to expanding into the OB/GYN space. Clearly, it's an interesting area as a first point of contact. And I'm just wondering if you -- 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?

So you mean expansion of Supernus into other areas in women's health?

No, into the OB/GYN market as a target audience.

On Zurzuvae.

Yes, yes.

Yes. Yes. 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 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.

Yes. No, I was referring specifically to Zurzuvae. And the timing -- is there any timing on that? Or that's just a future goal?

Yes. I mean we don't have any specific -- 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. I don't have a specific timing to tell you. Definitely, we'll do it in '26 or mid-'26 or '27. I truly don't have that.

I am showing no further questions at this time. I would now like to turn it back over to Mr. Jack Khattar for closing remarks.

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, 2 products that were launched less than 2 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 4 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.