Operator
Good afternoon, and welcome to Soprna's Pharmaceuticals First Quarter 2026 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will follow at that time. As a reminder, this conference is being recorded. I would now like to turn the conference over to Peter Vazzo of ICR Healthcare, investor relations representative for Sopernas Pharmaceuticals. You may begin.
Thank you. Good afternoon, everyone, and thank you for joining us today for Sopernas 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 Sopernas' Chief Executive Officer, Jack Katar, and Chief Financial Officer, Tim Dan. Today's call is being made available via the investor relations section of the company's website at www.ir.sopernis.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 Sopernis' current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve risk and uncertainty, including those noted in the risk factor section of the company's latest SEC filing. 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 5th, 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. Sopernas declined any obligation to update these forward-looking statements, except that's required by clickable securities loss. I'll now turn the call over to Jackson.
Thank you, Peter, and thanks everyone for taking the time to join us on today's call. Sopernas' 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 Onetco, during the first quarter, Onetco 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 of each 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 Onapto. We expect regulatory submission to the FDA in the third quarter of this year with potential approval before mid-year 2027. Switching now to Zerzube, Sopernas reported $27.6 million in collaboration revenues in the first quarter. Full first quarter 2026 U.S. sales of Zerzube, as reported by Biontun, increased approximately 100% compared to the same period in 2025. In the first quarter of 2026, Zerzule saw strong growth of 82% and 73% in rhythm 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 Zerzule. Regarding Kelby in the first quarter and as reported by Icubia, 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, Kelby's growth continues to be solid, and is coming from both patient populations with adult prescription growth of 27 percent and pediatric prescription growth of 15 percent. In addition, the total quarterly number of prescribers for Calgary reached a high of approximately 43,000 with adult prescribers for the first time surpassing the number of pediatric prescribers. Switching now to recovery 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 2B randomized double-blind placebo-controlled trial with SPNA 20 in approximately 200 adults with major depressive disorder is ongoing. This study will examine the safety and tolerability of SPNA 20 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 2B randomized double-blind receiver control study of SPN817 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 SPM443, our novel stimulant ADHD product candidate, we expect to initiate a phase one 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 for 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 10Q 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 zirzuve 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, Calgary, CoCovery, and Anabco, as well as the addition of collaboration revenues from Zurzune. 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 Shinogi. 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. GAP net loss was $2.3 million for the first quarter of 2026, or net loss per share of $0.04, compared to GAP 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 31st 2026 the company had approximately 384 million in cash cash equivalents and marketable securities compared to 309 million as of december 31st 2025. this increase was formerly due to cash generated from operations the timing of medicaid payments and the shinogi related commercial milestones 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 sdna 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
Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from Andrew Tsai from Jefferies. Your line is now open.
Hi, thanks for the updates and thanks for taking my questions. Specifically on ANAPCO, 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 ultimately will be ultimately converted to a patient, 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.
Yeah, 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 percent of these, you know, patients in the process for all kind of reasons um whether it's you know change in the medical condition of the patient over time the insurance issue um any of these reasons you know 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 trying to get more information from them to be able to process it sometimes you just don't call it back. And then as far as the period of time, I mean, it could take several weeks. As we, you know, 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, you know, for somebody to have the form submitted until finally they get the product shipped.
Got it. Thank you. And so, following up on that, to get to your ANAPCO guidance, the high end of 75 million, mathematically, you're going to be needing more than 700 patients on therapy. So, if I did 2,200, 50% conversion, that would be over 1,000 patients potentially on ANAPCO. So, it looks like you can get there. So, can you remind us how many patients are still on ANAPCO today and when could you expect most of those kind of hypothetical patients to get on drug, you know, should it be within the next three to six months then? Thank you.
Yeah, I mean, the high end of our guidance is, you know, the 70 million. You're thinking about it the right way, yes, I mean, that could translate to somewhere around set on an average about 700 patients, you know, that you need to have around 700 patients throughout the whole year, clearly, to give you the 70 million, you know, 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, you know, 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 2200 uh if we look at the backlog right now we have probably somewhere around 570 uh you know give or take patients in the queue versus you know 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 um remember i mean we just restarted the whole machinery so to speak or the whole process started you know middle to end of february so to speak so it's taken us march and we've been very happy with the progress you know the team has made through march really getting us to very high levels as i mentioned in my previous remarks even exceeding you know 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 maintain the guidance, of course, because we would like to see another full quarter. So 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 you know several metrics with the demand continuing to be strong as you pointed out with the 2200 forms but also with the way the team is processing these forms and trying to minimize you know the drop-offs and losses throughout the process but we feel still pretty good obviously and that's why we didn't change the guidance, they're still pretty good about the $45 to the $70 million guidance on NAPCO.
Operator
Thank you. Our next question comes from the line of David Amselm from Piper Sandler. Your line is open.
Hi, yes, this is Alex on for David. Thanks for taking our questions. First one, sort of jumping off of the last question regarding the guidance range for a NAPCO 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 drugs? And then secondly, regarding Zerzoube, can you maybe speak to how you're thinking about the growth runway of the product?
Yeah, regarding Zerzoube, 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, a 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, and 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. You know, 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 Zerzube since launching. You know, and we're into year three right now. So we have a long way to go with Zerzube, 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, you know, pretty nice expectations of growth from the product. Regarding, if I understood your question on Onapco, is it really the patient profile and the kind of patient, you know, we're getting on Onapco? It looks like we're starting to get, you know, 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, you know, patients tend to be more on the younger side as far as age and or the disease, meaning, you know, they haven't been diagnosed for a long, long time. They tend to be active. They tend, you know, to really be looking for, specifically from a physician perspective, they're looking for something different than a libidopa carbidopa. So that's the kind of patient profile that seems to be emerging right now as we speak on the UNAPCO side.
Thank you. And then what are you seeing in terms of patient persistence for UNAPCO?
Yeah, 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, you know, the refills and how many patients stayed with us around the time of the supply constrained. 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 and 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, then 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, you know, that historically has been in Europe.
Operator
Thank you. Thank you. Our next question comes from the line of Kristin Kluska from Cantor. I apologize.
It's okay. Yeah. Hi, everyone. Congrats on a great start to calendar year 2026 here. Just on a NOPCO, as we think about the mid-2027 approval, how are you working with your partners out in Europe? about 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 strengths are still there to an extent, are you seeing that physicians are prioritizing certain patients over another just knowing that they might not be able to get their hands on enough supply for all of the patients they'd want to treat?
And regarding the last question, I mean, we haven't detected anything specific that because of, you know, the previous supply chain strain that they're using the product on a different patient or one patient versus another. So we can't really 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, you know, had 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, you know, 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, you know, backups from a supply perspective to make sure we meet the demand, not only in 2027, of course, and, you know, several years beyond that.
Okay, thanks. And then on Zerzuve, how are you seeing adoption in line with the prescribing? Meaning, like, are you seeing some patients are coming back for 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 thanks again you know do it typically I mean the people stick with the 14 course 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 three. So that obviously even reinforces it and encourages them to finish, you know, the 14-day therapy. And with Azubay, you know, obviously it's a very different kind of business. You don't have refills. You know, of course, unless mom, you know, gets pregnant again, and, you know, it's another year or cycle, so to speak, and she happens to have also PPD second part you know with the second pregnancy but normally there is no relapse or anything like that for them to come back and cycle through it again thanks Jack thank you and our next question comes from the line of Vishwesh Shah from TD Cohen your line is now open I think you can rest to you guys on another great quarter.
So on Calibri, what are you seeing in terms of some of the adoption trends right now? You commented on some of the adults trying out Calibri, 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.
Thanks. Yeah, we're actually very excited on Calvary and what we really saw in the first quarter, and it's a pretty interesting dynamics in a very positive way, specifically in the adult segment of the market. So there are several things that I would, you know, pretty much emphasize on Calvary. Clearly the adult growth has been now outfacing 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, adult 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, you know, a little bit more emphasis on adults especially when we are out of the back to school season because we rotate of course uh the emphasis we rotate the resources uh 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 only view uh 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 uh this is for the first time now number of prescribers in the adult have surpassed our number of prescribers in pediatrics i really jumped pretty quickly uh 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 a brand as it you know stays on the market for a while and now we're into year six pretty much you know in May we're in year six of the brand The patient profile is broadening, so it's not anymore, you know, some of the early low-hanging fruit that you're getting, basically. What I mean by that is you're really getting much broader types of patients into the franchise, and physicians are starting to think of so many different types of patients and needs out there that Calgary could be the answer for. For example, you know, 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, you know, 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 immediate release stimulants to give them that full-day coverage. Well, with Calvary, 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, they're finding more ways to use Calvi as a true solution for a lot of their patients. And then, of course, you know, those who are partial responders to stimulants, I mean, stimulants work, but they don't work for everybody. And we sometimes we forget that. And, you know, a lot of physicians are using it for those partial responders, you know, to stimulants. And then the complex ADHD, and, of course, that comes with time, you know, 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 Kelvin could really play a role with these patients who have that what we call complex ADHD because of the serotonin modulation, you know, and the very unique multimodal activity and pharmacodynamic profile of Kelvin. So a lot of very exciting things continue to happen there and really a lot of momentum in the brand.
Thanks. And then on – thanks so much for all the details. And then on Onapco, what dynamics are you seeing between patients opting for Onapco versus Vilev? So what kind of competitive dynamics are you seeing there?
Yeah, 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, you know, a different drug, different mechanism different molecule and therefore they would go and turn to something like an apple and vice versa if the physician feels that the patient may still benefit from some libidopa carbidopa maybe for another year or two and then they might consider an apple so they might go and you know towards something like buy it something else instead of connectable so that's the first type of uh you know 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 active side earlier in the disease um versus the vial of patient tends to be a little bit more on the older side you know we're trying to dig into deeper into this to really understand what's behind you know some of that some of the folks who may need and have very difficult time at night they may choose Violet because you have you put Violet 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 you know 24 hours but with Violet 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 an echo or mild got it thank you very much thank you our next question comes from Annabelle Samini from stifle your
line is now open hi this is Jack on for Annabelle thanks for taking our questions and congrats on the quarter um so answer zuve i know that there are the active dtc campaign running right now clearly the product has been doing very well overall um 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 yeah unfortunately no because it's really early you know for to be able to have a good read i mean we just started it and you need
you need set you need several months of data to get a meaningful read on a response if you're getting a good response from the dtc now the only thing i can tell you is kind of anecdotal you know 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 you know 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 you know 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 you know healthcare provider side and that's what we're 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 you know continue to be invested in but again initial signals, which are more anecdotal, seems to be, you know, positive.
No, no, 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?
Yeah, no, I mean, our priority is revenue-generating assets that we can wholly own it and, you know, 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 three years, you know, from the time we acquired them.
Operator
So that's really what we're very much focused on. and fairly agnostic in the cns space and and of course women's health as well great thank you thank you and our next question comes from xi fong from bank of america your line is now open hey guys uh thanks for taking our questions um i want to follow up on uh bringing the second supplier online for ONAPCO.
Um, did you get a chance to meet with the FDA to get any sort of feedback or alignment on some of the path of getting the approval? Did any of the feedback help inform the timeline guidance you have 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 um and on approval timeline you've guided to by mid 2027 i recall on the last earnings call you talk about review timeline could be a range somewhere in the six to nine 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 have a follow-up after that yeah 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, could be six months to nine months. So that will fall at the outer, you know, at the upper end of the timeline, you know, nine months. That means mid-year 2027. And if it does take only six months for review, that obviously will be within that, you know, earlier than that. So that's pretty consistent. And the FDA was consistent with their feedback, you know, with all the discussions we've had with them.
So depending on when exactly we find, you know, July, August, September, whatever, and then you add six months to it or it could take nine months i mean that's really within that frame that we just gave today great and my follow-up is um obviously the second supplier already has experience applying the product in europe um but given the sometimes idiosyncratic nature of the head agency handing out manufacturing issue citations and the second more broadly can you talk about the confidence level of timely clearance of the second supplier i mean we we
have no indication that you know um something could happen that is you know that could really put the derail this timeline from that perspective um 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 us in 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 six to nine months because of that specifically but we're not aware of anything that could tell us you know that this could derail this thing completely uh you know and make it not an option for us at all so we're pretty confident you know, that we should be able to meet that timeline and secure that second supply.
Okay, great. Thanks so much for answering our question.
Operator
Thank you. So I am showing no further questions at this time. I would now like to turn it back over to Peter Vazzo.
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 behind 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.
Operator
Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.
