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 Representative for Supernus Pharmaceuticals. Please go ahead.
Thank you, Angela. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' Third 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 ir.supernus.com. Before we begin, I'd like to remind you that we will be making forward-looking statements. All 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 can 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, ONAPGO, 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 ONAPGO, during the third quarter of 2026, ONAPGO 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 ONAPGO 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 convenient 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. Full 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 SPN-820 and SPN-817 phase IIb studies continue to enroll subjects with major depressive disorder and focal seizures, respectively. The SPN-443 program is expected to start a 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 2nd.
As you may have seen earlier today, Indivior's results for the three months and nine months ended September 30th, 2026, were also strong and driven by continued record performance of SUBLOCADE. Combined with Supernus' solid performance and outlook, 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 are 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 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, collaboration 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 ONAPGO. 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 were $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 cost for the Sage acquisition in the third quarter of 2025, partially offset by higher revenues. GAAP net earnings were $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 the prior year. Total revenues for the first nine months of 2026 were $653.5 million.
Excluding net product sales of Trokendi XR and Oxtellar 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 royalties, licensing, and other revenues of $53.8 million. Combined R&D and SG&A expenses for the nine months ending September 30th, 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 of intangibles, share-based compensation, contingent consideration, depreciation, and acquisition-related costs, 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 30th, 2026, the company had approximately $359 million in cash, cash equivalents, and marketable securities, compared to $309 million as of December 31st, 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- $900 million, up from the previous guidance of $860 million- $890 million. And finally, we expect full year 2026 non-GAAP operating earnings to range from $160 million- $180 million, up from $150 million- $180 million. Assuming the merger with Indivior closes on November 2nd, 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.
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, and we will do that at the appropriate time. With that, I now turn the call back over to the operator for Q&A.
Thank you. At this time, we will conduct the question and answer session. To answer a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. 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. I am curious if you and your partner feel like you are in a good position right now in terms of reps messaging out there, or if there is any plans to grow this. My second question on ONAPGO. I 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 manufacturer on board next year?
Yeah. Hi, Kristen. Regarding ZURZUVAE, the brand is doing extremely well, and we are very excited about how it is doing now, but also, more importantly, the future of the product. No matter what metric you look it has really been phenomenal as far as the growth of the product. Of course, this year we also started the DTC campaign. We have been very encouraged with what we have seen so far. Early metrics, but very good signals that there are a lot of great things that are coming out of that campaign. That is why we continue to see strong demand behind the product. All-time high metrics across the board, number of prescribers, patients, and so forth. We are really excited. So far, if you really look at the product since we launched it, we have only treated a little bit north of 40,000 patients since launch.
There is a lot of opportunity in front of us here. There are a lot of moms that need to really be aware of the disease, step forward, seek help. We are 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 ONAPGO 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. The third quarter was a nice clean quarter, so to speak, from that perspective. That gave us a little bit more time, actually, to even try to optimize the process.
We have done a lot of optimization and improvement in the process and the processing of the form to shipment. 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. A lot of the folks who are in the queue are pretty much fresh and new forms that have been submitted. We do not 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.
We are 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. the demand, similarly, if you look, not different than ZURZUVAE, where we continue to see very good metrics, on aggregate across different metrics here, the prescriptions, 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.
Thank you.
Thank you. 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 our 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 that's the first question that we do get a lot of inbounds on. Then a quick follow-up, as we think about spend and synergies. There's a guidance on synergies with Indivior for next year, but maybe also remind us where you are with Sage and spend, especially with the ZURZUVAE growth. Are there any additional synergies that can be realized over there? Is that all done? 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.
Yeah. Regarding the M&A activity and whether it's a priority or not, we're always looking for potential opportunities to continue to grow our portfolio. 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 partnerships with them. As far as the top priorities, of course, six months after the merger, as I mentioned, 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 potential future transactions.
Regarding the synergies, 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, the $125 million on an annual basis. So that we feel will be on track, and we're very confident with our ability 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 hitting the target we have on the Indivior merger. And then regarding the last question, as far as Qelbree, overall big picture, Qelbree is doing really well. We're very pleased with Qelbree and the trends on the prescriptions.
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 23% in the third quarter. We had a very strong third quarter, very strong growth in the number of prescribers. 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, adults continued to outperform the pediatric growth. We're very pleased with both segments, the pediatric and the adult. And the product is so differentiated in the marketplace 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. We really feel pretty good about the position of the product, its delivery, and its future. Overall, we're still around 1% market share, and this market has been incredibly resilient and continues to grow at 10%+ in prescription, which is truly amazing in the CNS space. 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. Thanks for taking my call. I know you're not really talking about the Supernus Indivior combination at this stage, but given that the combination is going to supply you with the balance sheet and the additional 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 continued growth of the products? For example, ZURZUVAE, have you moved into more of the OB-GYN space, and are you doing anything there to potentially enhance some of the growth of some of your current portfolio? Then, separately on ONAPGO, 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 ONAPGO? Thanks.
Yeah, regarding the merger, 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, ONAPGO, ZURZUVAE and so forth. So that will be one of the key areas where we would look at what else can we do? Are there any other programs we would like to consider, and so forth. So that's something definitely we'll be looking at to maximize these brands, all of them, and maximize their potential and growth in the future. Then as far as ONAPGO and the run rate, it's been around the 400. It ticked up a little bit, but it's been around the 400, 425. 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 more and continue to grow it hopefully as time goes on.
Great. Thank you.
Thank you. Our next questions come from the line of Chi Fong of BofA. Your line is now open.
Hey, guys. Thanks for taking my questions. First one I have is, I want to ask about just the operating margin. Looking at the 3Q results and the guidance of the midpoint imply roughly around mid-20% margin, better than the mid-teens in the first two quarters. As we think about Supernus as the current standalone entity, where is the opportunity for margin expansion next year relative to current level? Is it fair to assume a higher operating margin than the 20% implied in a 2026 guidance for Supernus as a standalone entity?
Yeah, regarding the—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 assume standalone and there is no merger or whatever, clearly, as time goes on, our plan has been to continue to improve our operating margin. That goes without saying because it's a natural phase that you go through as you launch products, you invest behind them, you expand, you spend money on 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'll do that commensurate with the life cycle of every product. 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. With the new company, we will have a lot of different dynamics at that point.
Got it. My second question, I want to ask about SPN-817 which is currently in phase II development for epilepsy. I am curious, can you talk about timing of the data and expectation for the readout?
Yeah. Right now, given the rate of recruitment, it looks like most likely, and we will 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 is going to be in 2028. I do not have more specifics as in first quarter, second quarter, third quarter. We will come back with more information as we get better feel for the recruitment. These epilepsy trials tend to be slow in general. So we are basically going at very similar rates as everybody else in the industry in doing these trials. So 2028 will be a good guess, but when in 2028, we will try to nail it down and get it a little tighter as time goes on.
If I may squeeze one in. This is a follow-up to Annabel's questions earlier. So curious, obviously more than 400 new forms were submitted for ONAPGO this quarter, similar to the run rate the first couple of quarters. Jack, were you surprised that the number of new forms submitted have not picked up meaningfully since the resolution of the supply shortage? Looking ahead, what are the upside levers that new forms and new scripts could pick up meaningfully from current run rate?
Yeah. The answer to the first question, it wasn't surprising because we knew we were relaunching the product, basically. Not that we're starting from scratch, but 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 are more in a relaunch mode. 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. Clearly, as I mentioned earlier, 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. 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. All this will help us, hopefully, make this a growing number as time goes on, beyond the 400 and go above that. Clearly stay tuned to any updates as time goes on, but we feel pretty good about the basics for the demand of this product. Yeah.
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 are 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.