2/24/2026

speaker
Operator
Conference Operator

Good afternoon and welcome to Sopranos Pharmaceuticals for the quarter and full year 2025 financial results conference call. At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session. Instructions will follow at this time. As a reminder, this conference is being recorded. I would now like to hand the conference over to Peter Bozzo of ICR Healthcare, Investor Relations Representative for Sopranos Pharmaceuticals. You may now begin.

speaker
Peter Bozzo
Investor Relations Representative, ICR Healthcare

Thank you, Antoine. Good afternoon, everyone, and thank you for joining us today for Sopernos Pharmaceutical's fourth quarter and full year 2025 financial results conference call. Today, after the close of market, the company issued a press release announcing these results. On the call with me today are Sopernos' Chief Executive Officer, Jack Attar, and Chief Financial Officer, Tim Deck. These calls 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 guaranteed of future performance They involve risks and uncertainties, including those noted in the risk factor section of the company's latest SEC filings. As a result, may differ materially from those projected in this forward-looking statement. For the benefit of those of you who may be listening to the replay, this call is being held to record it on February 24th, 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 of the SEC. Sucurnis declined any obligation to update these four elective statements except as required by applicable securities laws. Announce the call of the executive.

speaker
Jack Attar
Chief Executive Officer

Thank you, Peter. Sucurnis had a remarkable 2025 with significant progress made against our strategic objectives. The company achieved the record total revenues of $719 million delivered strong growth of 40% in revenues from our four growth products, successfully executed an integrated acquisition of Sage Therapeutics, obtained the FDA approval of Onapco, and launched Onapco in the Parkinson's market. Our financial performance in 2025 once again underscored our emphasis on growing our core business, despite the loss of exclusivity on both Trochendi XR and Oxtelra XR. With our four growth products, Calvary, Recovery, Zerzuve, and Onepo, we have built a solid foundation for a new phase of accelerated growth for Supernos. During the fourth quarter of 2025, revenues from these four growth products accounted for approximately 76% of total revenue. Starting with Onetco during the fourth quarter of 2025, Onetco generated net sales of $8.9 million up from $6.8 million in the third quarter of 2025 and finished its first year on the market with $17.3 million in total net sales. Demand for the product continues to be healthy despite the announced supply constraints with more than 540 prescribers submitting over 1,800 enrollment forms since the launch of the product and through the end of January 2026. We have been focused on resolving the supply constraints that we discussed on our third quarter 2025 earnings poll. Progress with the current supplier has been made allowing us to resume new patient initiation while continuing to service our existing Monaco patients with maintenance therapy. Our current outreach effort for verifying health benefits and coverage includes more than 700 patients whose forms are currently in the queue for processing. In the fourth quarter of 2025, prescriptions grew by 29.6% and the number of prescribers grew by 28% compared to the third quarter Switching now to Zerzuve, the brand had strong performance in 2025 with $32.8 million in collaboration revenues in the fourth quarter and $53 million for the five-month period since the closing of the Sage acquisition on July 31, 2025. Full fourth quarter 2025 U.S. sales of Zerzuve as reported by Biogen, increased approximately 187% compared to the same period in 2024, and approximately 19% compared to the third quarter of 2025. The number of prescribers in 2025 doubled compared to 2024, with more than 70% being repeat prescribers. Total prescriptions in 2025 increased by more than 150% compared to 2024. Regarding Calgary, the product had another year of robust performance with 21% growth in total annual prescriptions in 2025 compared to 2024 and as reported by IQMIL. Calgary exceeded $300 million in net sales for the year 2025 delivering 26% growth compared to 2024. In 2025, the brand delivered double-digit prescription growth of 29% and 18% in both the adult and pediatric patient populations, respectively. For the fourth quarter of 2025, total descriptions increased by 18% compared to the same period in 2024, while net sales increased by 9% as net sales were impacted by an annual gross to net deduction. This was due to an unexpected bill of $4 million received from one of the PDMs covering the full year of 2025 and which was fully reflected in the fourth quarter. For full year 2025, gross to net for Calgary ended up at approximately 49%. Our expectation for 2026 continues to be consistent with our previously disclosed target of 50 to 55%. Switching now to recovery for full year 2025, net sales reached 146 million, increasing by 12% compared to 2024. And total annual descriptions reach an all-time high of approximately 67,000. growing by 14% compared to 2024. The brand finished 2025 with strong prescription growth of 16% in the fourth quarter compared to the same period last year and with net sales of $38.6 million. Moving on to R&D, we initiated a follow-on Phase IIb randomized double-blind placebo-controlled trial with SPNA20. in approximately 200 adults with major depressive disorder. This study will examine the safety and tolerability of SPN820 and its efficacy at a dose of 2,400 milligrams, given intermittently twice per week as an adjunctive treatment to the current baseline antidepressant therapy. Our face-to-be randomized double-blind placebo-controlled study of SPN817 is ongoing with a targeted enrollment of approximately 258 adult patients with treatment-resistant vocal seizures. This trial utilizes three milligram and four milligram twice daily doses. And for our SPM443 program, we expect to initiate a phase one single ascending and multiple ascending dose study in adult healthy volunteers in the second half of this year. We have completed our evaluation of the early stage pipeline assets from the SAGE acquisition. As a result, we will retain certain assets for internal development and we will be seeking partnerships for the remaining assets. Finally, corporate development will continue to be a priority for us as we look for additional strategic opportunities to further strengthen our future growth and leadership position in CNS through revenue generating products or late stage pipeline product candidates. With that, I will now turn the call over to Tim.

speaker
Tim Deck
Chief Financial Officer

Thank you, Jack. Good afternoon, everyone. As I review our fourth quarter and full year 2025 results, please refer to today's press release that was filed earlier today. We achieved record total revenue of $211.6 million for the fourth quarter of 2025. an increase of 21% compared to the same quarter last year. Excluding net product sales of Trikendi XR and Xtellar XR, total revenue for the fourth quarter of 2025 increased 34% compared to the same quarter last year. Total revenue in the fourth quarter of 2025 was comprised of net product sales of $158.1 million, collaboration revenues associated with Zerzuve of $32.8 million, and royalty, licensing, and other revenues of $20.7 million. This includes $15 million of licensing revenue recognized in the fourth quarter of 2025 related to the achievements regulatory milestone under our collaboration agreement with Shinogi. Please note, collaboration revenues represent approximately 50% of the sales of Zerzuve reported by Biogen. This increase was primarily due to the increase in net products sales of our growth products, Calvary and GoCovery, as well as the addition of collaboration revenues from Zerzuve and from the launch of Enabco in April of 2025. For the fourth quarter of 2025, combined R&D and SGN expenses were $150.2 million as compared to $108.1 million for the same quarter last year. Operating loss on a GAAP basis for the fourth quarter of 2025 was $4 million as compared to operating earnings of 21.4 million for the same quarter last year. The change was primarily due to higher SAGE operating costs in the fourth quarter of 2025 and incremental intangible asset amortization for Zerzuve and Enabco. GAAP net loss was 4.1 million for the fourth quarter of 2025 or a loss of $0.07 per diluted share, compared to gap net earnings of $15.3 million, or $0.27 per diluted share, in the same quarter last year. On a non-gap basis, which excludes amortization intangibles, share-based compensation, contingent consideration, depreciation, and acquisition-related costs, adjusted operating earnings for the fourth quarter of 2025 was $48.5 million, compared to $48.3 million in the same quarter of last year. Total revenues for the full year 2025 were a record $719 million, excluding net product sales of Drukendi XR and Xtellar XR. Total revenue for the full year 2025 increased 27% compared to last year. Total revenues were comprised of net product sales of $626.6 million, Zerzuve-related collaboration revenues of $53 million, and royalty and licensing and other revenues of $39.4 million, including the aforementioned $15 million of licensing revenue received due to a regulatory milestone. During 2025, collaboration revenues represented sales reported by Suppress since the close of the SAGE acquisition on July 31, 2025. Combined R&D and SG&A expenses for the 12 months in December 31st, 2025 were 591.8 million as compared to 430.4 million last year. The change was primarily due to higher SG&A expenses, including approximately 73 million of acquisition-related costs from the SAGE acquisitions and approximately 50 million related to the SAGE operating costs recorded since the closing of the acquisition. Operating loss on a GAAP basis for the full year 2025 was 62.3 million as compared to operating earnings of 81.7 million for 2024. GAAP net loss was 38.6 million for the full year 2025, or a loss of 68 cents per diluted share, compared to a GAAP net earnings of 73.9 million for $1 and $0.32 per diluted share in 2024. On a GAF non-basis, which again excludes amortization intangibles, share-based compensation, contingent consideration, depreciation, and acquisition-related costs, adjusted operating earnings were $158.7 million compared to $183.7 million for last year. As of December 31st, 2025, the company had approximately $309 million in cash, cash equivalents, and marketable securities, compared to $454 million as of December 31st, 2024. The decrease in our cash was primarily due to the funding of the Sage acquisition, offset by cash generated from operations. The company's balance sheet remained strong with no debt and significant financial flexibility for potential M&A and other growth opportunities. Now turning to 2026 guidance. For full year 2026, we expect total revenues to range from 840 million to 870 million, comprised of mint product sales, Zerzuva collaboration revenues, and Royalty and licensing revenues. Note, total revenue guidance for full year 2026 assumes approximately 45 million to 70 million of med sales from a NAPCO. As Jack mentioned, new patient initiation for a NAPCO begin in the first quarter of this year. For the full year 2026, we expect combined RMD and SG&A expenses to range from 620 million to 650 million. Overall, we expect full year 2025 operating and the operating income loss in the range of breakeven to a loss of 30 million. And finally, we expect non-GAAP operating earnings to range from 140 million to 170 million. Please refer to the earnings press release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non-GAAP. With that, I will now turn the call back to the operator for Q&A. Operator?

speaker
Operator
Conference Operator

Thank you. At this time, we will conduct a question and answer session. To ask a question, you 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 I compile the Q&A roster.

speaker
Operator
Conference Operator

Our first question comes from Andrew Sy from Jeffries.

speaker
Operator
Conference Operator

Please go ahead.

speaker
John Cox
Analyst

Hey, guys. This is John Cox on behalf of . Congrats on the quarter, and thanks for taking my question. So just so we understand, the current supplier can supply 45 to 70 million of sales. And to get to that 70 million, can that be done by the current supplier, or does the high end require you to lock in the second supplier, say, like earlier than 2027?

speaker
Jack Attar
Chief Executive Officer

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

speaker
John Cox
Analyst

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

speaker
Jack Attar
Chief Executive Officer

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

speaker
Operator
Conference Operator

Great. Thanks so much. Congrats again.

speaker
Operator
Conference Operator

Thank you. Our next question comes from David Enselem from Piper Sandler. Please go ahead.

speaker
David Enselem
Analyst, Piper Sandler

Thanks. So two for me. First on NAPDO, and I apologize if I missed this, I just want to clarify. So with the additional capacity, how much of underlying demand can you meet? Or maybe ask another way. can you fully clear the backlog, if you will, with the additional capacity that you now have in place? So that's number one. And then secondly, regarding the R&D organization with the integration of Sage, you mentioned you're taking on some early-stage products and just wondering out loud, you know, how you're thinking about prioritizing those, especially relative to your legacy pipeline assets, and when we might get some updates on what you're going to bring forward into the clinic there. Thank you.

speaker
Jack Attar
Chief Executive Officer

Yeah, regarding ONAPCO, the current supplier will certainly help us clear the backlog. you know, through the continuous supply that we will be able to have throughout 2026, and more than just the backlog, of course. And because we are initiating new patients, and not just with the current situation, meaning the 1,800 forms or 700 patients in the process, of course, that number will continue to be refilled during the year as we continue to grow the number of forms and so forth. We expect the current supplier to be able not only to clear the backlog, but also, of course, continue to provide for whatever needs we have throughout 2026 until we get, you know, the second supplier online. As far as the SAGE R&D programs and so forth, I mean, these are really early stage assets. For now, we will be doing some, you know, early preclinical work, things like this, you know, to verify, you know, the activity, the mechanism of action, the selection of an indication, and so forth. So, there will be a lot of preclinical type of work that has to be done on these assets. So, as far as prioritizing them within, you know, the portfolio that we have, we look at every product separately on its own merits. from a timing perspective, market opportunity, you know, ROI, and so forth. So, I mean, they will go through the same process of prioritization from a portfolio perspective.

speaker
David Enselem
Analyst, Piper Sandler

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

speaker
Jack Attar
Chief Executive Officer

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

speaker
David Enselem
Analyst, Piper Sandler

All right. Thank you, Jack.

speaker
Operator
Conference Operator

Thank you. Our next question comes from Stacy Koo from TDTowin. Please go ahead.

speaker
Stacy Koo
Analyst, TD Cowen

Hey there. Thanks so much for taking your questions. Congratulations on an earnings update and the UNAPCO supply update. So first, as we think about the UNAPCO guidance for the year, and the patient demand that all the analysts are trying to triangulate around. Maybe first, could you talk about the learnings on the patient profile since launch? Maybe talk about the frequency of use that you're seeing, what we're trying to understand, better understand, obviously, there's going to be a range, but how should we be thinking about the potential net pricing for a year of treatment? So that's the first question. And then when it comes to the resumption of the new patient initiations for NAPGO, should we be thinking about that 1,800 enrollment forms is reflecting a more limited writing from clinicians despite the supply disruption? Just a bit of a point of clarification for our second question. And then the third, as we're just, again, trying to understand the enrollment forms, as the sales force is going back to the clinicians and patients, What kind of dynamics are you seeing in terms of on-op-go demand in such as to buy lots? Our understanding is that the behind-the-scenes with commercial reimbursement and the infrastructure was kind of continuing, even though we didn't know whether there's going to be supply or not. Happy to clarify the finished question.

speaker
Jack Attar
Chief Executive Officer

Thanks. Hopefully, I'll get all of them. I'll start with the first one. As far as the, you know, the profile of the patient, I mean, these are folks that are Advance in the disease, a lot of the oral medications are not enough anymore, so they continue to have certainly a lot of episodes during the day, and they're not really well-controlled with rhodopocarbidopa and with any of the other adjunctive oral therapy that they're taking. And therefore, you know, they would be, and in the physician's mind, they would be good candidates for subcutaneous continuous, you know, infusion for something that is different than libidopo carbidopa. That is the case, and that's what the physician is looking for. And therefore, they would choose something like onepro, apomorphine as a molecule, as a drug, you know, for that patient. As far as the potential, you know, moving forward and where the net pricing is going to land. I mean, clearly, the product has been on the market for a very short period of time, you know, only eight months or nine months. Certainly, that will, over time, you know, will calibrate depending on what we end up doing, if we do any contracting and so forth. But we thought historically about, you know, on an average, it's probably $105,000, $100,000 per year on a WAC basis. you know, per patient. Now, that certainly assumes a certain usage, which we are starting to get a better feel for. I don't have the data as much as I would like to before I, you know, say, you know, that's exactly how people are using the product and how frequently they're using it. But the 100,000 typically assumes about a cartridge a day, you know, give or take, you know, to get to that price or cost per year per patient. And then the next question I did was basically on the 1,800 forms and so forth. If I really understood the question, I mean, think about it. That's like a funnel. That's like a bucket of all the demand. So that's why we try to give you this number to give you an idea of what the demand is. And then clearly, as we process these forms, as eventually as patients get the shipments eventually, you're going to lose some forms or some patients on the way. I mean, that's typical in any process or any specialty type of product. Typically, that's what happens. And you could lose certain patients in the process for many different reasons, whether it's incomplete information, you can never finish the form or complete it. You'll be surprised sometimes how many phone calls you have to make, whether to the patient or to the doctor's office to even complete a form so that you can start processing it. And then when the hub starts processing the form and then doing the adjudication for insurance, reimbursement, introduce some patients there. And then as time goes on, a patient may change their mind or their situation might change, medical situation. So for all these factors, clearly, you know, the 1,800 don't necessarily end up being 1,800 patients at the end of the day. And I don't know what was it. I don't know if there is another question after that.

speaker
Stacy Koo
Analyst, TD Cowen

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

speaker
Jack Attar
Chief Executive Officer

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

speaker
Stacy Koo
Analyst, TD Cowen

Got it. And then last question. If you may, if we could sneak one in on Calgary, just the Q1 dynamics in light of the normal seasonality and maybe some of the one-time impacts. I'm just curious how you all are thinking about the following quarter for Calgary.

speaker
Jack Attar
Chief Executive Officer

Seasonality on Calgary?

speaker
Stacy Koo
Analyst, TD Cowen

Correct, for Q1.

speaker
Jack Attar
Chief Executive Officer

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

speaker
Stacy Koo
Analyst, TD Cowen

Okay. Incredibly helpful. Thank you so much.

speaker
Operator
Conference Operator

Thank you. Our next question comes from Kristen Kaluska from Cantor Fish Chair. Please go ahead.

speaker
Kristen Kaluska
Analyst, Cantor Fitzgerald

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

speaker
Jack Attar
Chief Executive Officer

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

speaker
Kristen Kaluska
Analyst, Cantor Fitzgerald

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

speaker
Jack Attar
Chief Executive Officer

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

speaker
Kristen Kaluska
Analyst, Cantor Fitzgerald

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

speaker
Jack Attar
Chief Executive Officer

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

speaker
spk07

Thanks, Jack. Glad to hear these are coming together.

speaker
Operator
Conference Operator

Thank you.

speaker
Operator
Conference Operator

Our next question comes from Pavan Patel from BOA. Please go ahead.

speaker
Pavan Patel
Analyst, Bank of America

Hey, Jack and Tim. So first, congrats on the supply constraint resolution. I think this is a best case scenario, so really happy for both you and the patients. I know our own survey work has shown that the demand for this product is really strong among both movement disorder specialists and patients. So my first question is, as you work through initiating these 700 patients out of the queue, Should we expect a temporary drag on ONAVCO's gross to net in the first half of 2026? And will a significant portion of these patients require bridge supply or quick start programs while their benefits are being verified? And then I guess just like a modeling question, can we do more than $70 million with the supply that your current supplier is able to offer you, assuming that Stata and the second supplier are not online in 2026? And then just maybe one on Zirzuve, since I think that's a topic worth hitting as well. I think the 70% repeat prescriber rate is pretty strong. So maybe as you plan your commercial efforts in 2026, are you shifting your focus towards striving deeper penetration volume among those existing repeat prescribers, or is the priority going to be start being to expand the absolute number of OBGYNs and psychiatrists writing their first prescription. Thank you.

speaker
Jack Attar
Chief Executive Officer

Yeah. Maybe I'll start with the last question. On the Zouvet, clearly, I mean, we are still, and the way we think about it, we are still launching the product, you know. That's the mindset we always have with new products, really, always launching. And as we mentioned earlier, this is a market that hasn't been really prepared a lot before the product was launched because the initial indication was supposed to be MDD instead of PPD. So basically, the product was launched and the market is being built at the same time. So we still have a lot of work to do in building the market education-wise. The brand actually enjoys a very, very high awareness, but we need to turn that awareness into action. We need to turn that awareness into confidence by physicians and to have the courage to actually screen, diagnose, and treat PPD. So, we will continue a lot of the great programs, you know, that Bajan and Sage had actually, you know, had started way back when they launched the product and into 2025. We will continue a lot of these type of programs into 2026. And actually, this year in 2026, and some people may have already seen the commercial, we have DTC efforts as well to educate as well the consumer and make more and more women and mothers, you know, comfortable in talking about their condition and come forward and seek treatment because there is treatment and they can really feel much better. after taking a product that is only a 14-day treatment and not waiting too long for it to actually kick in within day three. So, a lot of activity behind Zerzuvi because we're only scratching the surface at this point as far as the potential of this product. I mean, launch to date, we treated around 28,000 plus patients. That's it. As some of you probably recall, you know, every year you have 500,000 women who actually experience symptoms of PPD, and only about half of them get diagnosed, and then 60 to 70 percent of those are treated. So, there's a lot of people that need help, and we can really help them pretty well. As far as current prescribers or new prescribers, I mean, like every other when it's still early in the launch, you're certainly getting a lot of new prescribers, clearly, you know, from a reach perspective. And also, as time goes on, you can have more frequency on these physicians. And certainly, those prescribers who are current prescribers, actually, the data shows us that 70% of the prescribers are repeat writers. So, clearly, we are getting a lot of business from the current prescribers. That speaks for, of course, also the high satisfaction level with the product and how it's performing. You know, so once a physician actually takes that first step and has the confidence, the conviction, and the courage to diagnose and treat, and once they see the result from the first patient, they tend to be repeat riders. And that's really very encouraging, you know, for the product at this stage. Moving on to... I mean, could we do more than 70 million? That is always potential, you know. I mean, that is also could happen. I don't know right now, but everything we have today, all the information we have as far as demand and everything, you know, got us to the point where we believe the range is really 45 to 70 million. Could it be that we could go above 70 million? I truly don't know right now. Otherwise, we would have had a higher end if we had, you know, comfort that we could go above that. So, we feel pretty good right now where we stand on APCO and the supply situation, and that's sort of the guidance that we gave is really to help folks to see where the goalposts are on both ends.

speaker
Pavan Patel
Analyst, Bank of America

Thanks, Jack. And then just on the gross-to-nets in the first half of 26, do you think that? I'm sorry. Gross-to-nets.

speaker
Jack Attar
Chief Executive Officer

Yeah, I mean, for on the gross-to-nets, as I mentioned earlier, I mean, it's probably going to be somewhere in the 20 to 30%, again, higher in Q1 typically and lower, you know, as the year goes on, because typically Q1 you're going to have, you know,

speaker
spk07

incentives and things that have, you know, a little pressure that goes to them. Thank you. Thank you.

speaker
Operator
Conference Operator

Thank you. Our next question comes from Annabelle Semeny from Stifel. Please go ahead.

speaker
Annabelle Semeny
Analyst, Stifel

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

speaker
Jack Attar
Chief Executive Officer

Yeah, regarding the CNS, you know, the pipeline on 817 and 820. I mean, 820, we just basically initiated the trial, so that's still early as far as enrollment, You would expect an NDD trial to recruit much quicker than typically an epilepsy trial. So, for 820 and 817, both trials, we're looking at data sometime in 2027. It's not going to be this year. Hopefully, as time goes on, we'll have a much better trajectory specifically on 817 because epilepsy trials tend to be much slower from a recruitment point of view. And also, you know, these are multi-center trials, specifically the one in 817, which is also geographically extends beyond the U.S. So, typically, those are also, you know, could potentially be slower. So, but data is not going to be any time before, you know, 2027. As time goes on, maybe in May or August this year, we'll be able to give you a better feel as a first half, second half, you know, first quarter, fourth quarter, whatever, we'll update folks as time goes on. As far as BD, absolutely. I mean, our focus has been CNS. We continue to be CNS, and we're agnostic whether that's neurology or psychiatry. And yes, we did say historically that we are willing to go outside CNS, and obviously, the stage acquisition in a way, you know, overlapped on both. It is a CNS product, but it got us into women's health. So, clearly, that's an area we are looking at right now. And our priorities will continue to be revenue generating, cash flow generating opportunities. And if there are any assets there that are pipeline assets, our preference would be more on later stage assets. Again, that could potentially give us new product launches in the, you know, 27 to 2030, 2031 timeframe. So, that's really the prioritization that we have and what we're working towards from that perspective. And as Tim said, you know, we have a nice clean data sheet, so we have flexibility on whether, you know, the transaction is a product, is it a company, is it a portfolio product? So, I mean, that gives us some flexibility there, obviously.

speaker
Annabelle Semeny
Analyst, Stifel

Great. Thanks so much.

speaker
Operator
Conference Operator

Thank you. This concludes the question and answer session. I will now turn it back to Jack Katar for closing remarks.

speaker
Jack Attar
Chief Executive Officer

Thank you for joining us on this call today. 2025 was a special year for Sopranos. It marked our 20th year anniversary and the completion of our successful transition from our legacy products to Kendi XR and Oxtel XR. In 2025, Sopranos delivered one of its best performances ever with record revenues of $719 million behind the robust performance of its growth portfolio consisting of Calvary, GoCoveri, Zerzube, and Onepco. Sopernos has now a diversified portfolio of growth products where our future success is not solely dependent on one single product. We expect to see continued healthy growth from Calvary and GoCoveri, augmented by significant growth from Zerzube and Onepco, two products that have been on the market for two years or less and have a significant market opportunity. In addition to our four growth products, we continue to advance our pipeline and to explore corporate development opportunities to position Sopernos as a long-term growth company while generating at the same time strong cash flows behind the strength of our expanded product portfolio and through the efficiency of our operations. Thanks again for joining us this afternoon. We look forward to providing you with updates throughout the year.

speaker
Operator
Conference Operator

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

Disclaimer

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