SUPN Supernus Pharmaceuticals Inc

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$41.84

Supernus Pharmaceuticals Inc Q3 F2026 Earnings Call Transcript

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Angela
Conference Operator
Good afternoon and thank you for standing by. Welcome to the Nus 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 Vosso of ICR Healthcare Investor Relationships Representative for Sopranos Pharmaceuticals. Please go ahead.
Peter Vozzo
ICR Healthcare Investor Relations Representative
Thank you, Angela. Good afternoon, everyone, and thank you for joining us today for Sopranos Pharmaceuticals' third quarter of 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 Sopernos' Chief Executive Officer, Jack Khattar, and Chief Financial Officer, Tim Deck. Today's call is being made available via the investor relations section of the company's website at www.ir.sopernos.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 Indivia 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 Sopernos website at ir.sopernos.com, and a replay will be made available shortly after this call is concluded. I'll now turn the call over to Jeff.
Jack Khattar
President and Chief Executive Officer
Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us on today's call. Today we will focus on Sopernos' 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 Endivio Pharmaceuticals. For the third quarter of 2026, combined revenues of our growth products, Calvary, Zerzuve, Onetco, and GoCoverie increased by 43% compared to the same period last year. Starting with Calgary in the third quarter, prescriptions as reported by IQBier 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, Calvary 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 reach an all-time high of $258 million. Calvary'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 Calgary reached a high of approximately 46,000. Moving on to ANATCO during the third quarter of 2026, ANATCO 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 quorum. 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 Monaco 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, the second source of supply, with approval expected by mid-year 2027. Switching to Zarzouvet, Sopernos reported $42 million in collaboration revenues in the third quarter and a hundred and five million dollars for the nine months period year to date. Full third quarter 2026 U.S. of Zerzuvae sales as reported by Biogen increased approximately by 53% compared to the same period in 2025. In the third quarter of 2026, Zerzuvae 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 Zirzuva. Switching now to recovery 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 Indivio Pharmaceuticals, I'm pleased to report that Supernus and Indivir 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, Indivir's results for the three months and nine months ended September 30, 2026 were also strong and driven by continued record performance of Sublocate. Combined with Soprano's 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.
Tim Deck
Chief Financial Officer
Thank you, Jack. Good afternoon, everyone. As I review our third quarter of 2026 results, please refer to today's press release and 10Q 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 Zerzuve 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 Zerzuve reported by Biogen. The increase in total revenues was primarily due to the increase in net sales of our growth products, Calvary, CoCovery, Zerzuve, and Anapco. 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. Gap net earnings was $20.9 million for the third quarter of 2026, or $0.35 per diluted share, compared to a gap 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 Oxtelra 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, Zerzuva-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 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-guide operating earnings. As such, we now expect full year 2026 total revenues to range from $875 million to 900 million, up from the previous guidance of 860 million to 890. And finally, we expect full-year 2026 non-GAAP operating earnings to range from 160 million to 180, up from 150 million to 180. Assuming the merger with Endeavor 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. And finally, before we open the call to questions, Please note that we would like to focus the Q&A on Sopernis 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'll do that at the appropriate time. With that, I now turn the call back over to the operator for Q&A.
Angela
Conference Operator
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 Christine Kluska of Cantor Fitzgerald. Your line is now open.
Kristen Kluska
Analyst, Cantor Fitzgerald
Hi, everyone. Congrats on all the progress over the last quarter here. A couple questions from me. First on Zerzuve, 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 out there, or if there's any plans to grow this. And then second question on Inopco. 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?
Jack Khattar
President and Chief Executive Officer
Yeah, hi, Kristen. Yeah, regarding the resume, 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 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, we've only treated and 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 moms 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 shipment. So 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 Zerzube, we continue to see very good metrics across different metrics here, the prescriptions, number of patients on therapy, new riders, all have grown in the quarter versus the previous quarter.
Kristen Kluska
Analyst, Cantor Fitzgerald
Thanks and all the best into the expected closing of the merger next week.
Jack Khattar
President and Chief Executive Officer
Thank you.
Angela
Conference Operator
Thank you. Our next question comes from the line of Stacy Q. of TD Cowen. Your line is now open.
Stacy Ku
Analyst, TD Cowen
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 it's the first question that we do get a lot of inbounds on. And then a quick follow-up as we think about spend and synergies. There's a guidance on synergies within Divier for next year, but maybe also remind us where you are with Sage and spend, especially with the NICE survey growth. Are there any additional synergies that can be realized over there? Is that all done? And then last, on Calgary, maybe talk about how net pricing is progressing and maybe expectations for the prescription trajectory for the rest of the year. Thanks so much.
Jack Khattar
President and Chief Executive Officer
Yeah, 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. You know 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 do partnerships with them. As far as the and others. Top priorities, of course, six months after the merger, as I mentioned, I mean, we will be very focused on the integration of the two companies, Endeavor and Sopernis. 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 end of your merger. And now regarding the last question, as far as Calgary, I mean, overall, big picture, Calgary is doing really well. We're very pleased with Calgary 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. 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 compared to the existing medications or even the recently approved products. Calgary 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 Kelvin.
Stacy Ku
Analyst, TD Cowen
Thanks so much. Appreciate it.
Angela
Conference Operator
Thank you. Our next question comes from the line of Abigail Samami of Stifel. Your line is now open.
Annabel Samimy
Analyst, Stifel
Hi, it's Annabelle. Thanks for taking my call. So, just, I know you're not really talking about the Supernas and Divior 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 projects? for example, 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 a NAPCO, 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 Ebola. So what is the right run rate for new patient enrollment forms for NAPCO? Thanks.
Jack Khattar
President and Chief Executive Officer
Yeah, 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, sublocate, calibrate, 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 the potential and growth in the future. And then as far as, you know, Eneco and the run rate, I mean, it's been around the 400. It ticked 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 more and continue to know it, hopefully, as time goes on.
Jack Khattar
President and Chief Executive Officer
Great. Thank you.
Angela
Conference Operator
Thank you. Our next question comes from the line of Chi Phong of B of A. Your line is now open.
Chi Pham
Analyst, Bank of America
Hey, guys. Thanks for taking my questions. First one I have is I want to ask about adjusted operating margin. So looking at the three key 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 supernas as the current standalone entity, where's 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 the 2026 guidance against for superna standalone entity?
Jack Khattar
President and Chief Executive Officer
Yeah, yeah, 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 we have the merged company. But assuming 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 margins. So 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. So naturally, the short answer is yes, we would have been able to improve our operating margin. Of course, these comments only apply to Sopernus as standalone. You know, the new company will have a lot of different dynamics at that time.
Chi Pham
Analyst, Bank of America
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?
Jack Khattar
President and Chief Executive Officer
Yeah, 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 of, you know, first quarter, second quarter, third quarter. That will come back, you know, with more information as we get better feel for the recruitment. 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.
Chi Pham
Analyst, Bank of America
And if I may squeeze one in, this is a follow-up to Annabelle's question earlier. So I'm curious, so obviously more than 400 new forms were submitted for UNAPCO this quarter, similar to the runway the first couple of quarters. Jack, 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 memory?
Jack Khattar
President and Chief Executive Officer
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 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, 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, but we feel pretty good about the basic, you know, the basics for the demand of this product.
Chi Pham
Analyst, Bank of America
Okay, great. Thanks so much. Sure.
Angela
Conference Operator
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.
Jack Khattar
President and Chief Executive Officer
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 Indivio and the value it will create. Thanks again for joining us this afternoon. We look forward to providing you with further updates on our products.
Angela
Conference Operator
Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.