Supernus Pharmaceuticals, Inc. (SUPN) Earnings Call Transcript

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.