Supernus Pharmaceuticals, Inc.

Good afternoon, and welcome to Supernus Pharmaceutical's fourth quarter and full year 2024 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 call is being recorded. I would now like to turn the conference over to Peter Vazzo of IVR Healthcare. investor relations representative for Sopernos Pharmaceuticals. You may begin.

Thank you, Jacinda. Good afternoon, everyone, and thank you for joining us today for Sopernos Pharmaceuticals' fourth quarter and full year 2024 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 Attar, and Chief Financial Officer, Tim Dex. Today's call will be made available via the Investment Relations section of the company's website at 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 risks and uncertainties. including those noted in the risk factors section of the company's latest SEC filings. Actual results may differ materially from those projected in these formative statements. For the benefit of those of you who may be listening to the replay, this call is being held and recorded on February 25th, 2025. Since then, the company may have made additional announcements related to the topics discussed. These reference the company's most recent press releases and current filings with the SEC. supports the client in the obligation to update these forward-looking statements, except as required by applicable securities laws. I'll now turn the call to Vidya.

Thank you, Vito. Good afternoon, everyone, and thanks for taking the time to join us on today's call. Our 2024 results reflect solid commercial execution across the company, including continued growth of our core products and strong growth in operating earnings. Our performance in 2024 underscored our emphasis on growing our core business despite the loss of exclusivity on both Trochendi XR and Obstetler XR. Total revenues excluding Trochendi XR and Obstetler XR increased by 25% for the full year 2024. Driving this growth was Calgary's robust performance with 25% growth in annual prescriptions as reported by Ikelia and 72% growth in annual net sales. In the fourth quarter of 2024, prescriptions reached another all-time quarterly high of 214,600 prescriptions. In 2024, Calgary's annual prescription growth outpaced that of the ADHD market that grew by 9%, reaching 103 million prescriptions. Calgary's back-to-school momentum carried through the fourth quarter with sequential prescription growth of 11% compared to the third quarter. This prescription growth enabled Calgary to have a strong fourth quarter with net sales reaching $74 million, representing a 60% increase over the fourth quarter of 2023. In 2025, Calgary is off to a good start with exciting news about the NFDA approval of its updated label. The new label further elaborates and differentiates Calgary's mechanism of action as a novel non-stimulum, reinforcing its multimodal pharmacodynamic profile and highlighting its unique partial agonist activity at the serotonin 5-HD2C receptor and inhibition of the epinephrine transport. Also, the label is now updated with new and important lactation data for breastfeeding women with ADHD. Such information is crucial for the important and growing adult female patient segment. In addition, earlier this month at the annual National Psychopharmacology Update Conference, Sopranos presented interim results from an open-label Phase IV trial with Calgary and adult patients with ADHD and mood disorders. Interim data for the first 95 patients who completed the trial show improvements in clinician and patient-rated measures of ADHD, depression, and anxiety symptoms. The data are encouraging and suggest that the effects of Calgary may extend to adults with complex ADHD. The safety outcomes in the trial were consistent with the double-blind pivotal trial of Calgary in adult ADHD. Full results from all the 161 adult patients who were enrolled in the trial are now available and are consistent with the interim results. That data will be presented at the American Psychiatric Association annual meeting in May of this year. Finally and importantly, the company received a two-plus-year patent term extension from the U.S. Patent and Trademark Office for one of the U.S. patents that covers Calgary. This extends the original expiration date of that patent to the year 2035. Regarding recovery, for fall year 2024, net sales increased by 9% compared to 2023, and by 15% in the fourth quarter of 2024, reaching $37 million. Earlier this month, the FDA approved on Apto, Sopernos' next growth product. It is the first and only subcutaneous apomorphine infusion device for the treatment of molar fluctuations in adults with advanced Parkinson's disease. We are targeting the launch of ONAPCO in the second quarter of 2025 with a support team of experts, including a nurse education program and access support. ONAPCO fits very well within our portfolio as it utilizes our existing Parkinson's disease sales force and infrastructure. Switching to our legacy products, the first generic for Oxtel XR entered the market in early September 2024, resulting in both a year-over-year and sequential quarter-to-quarter decline in net sales of Oxtel XR in the fourth quarter of 2024. For full year 2024, combined net sales of Trochendi XR and Oxtel XR were down 22%. In 2025, we expect further erosion in both product sales with combined net sales to be in the range of 65 million to 75 million. Moving on to our CNS pipeline of novel product candidates, in November 2024, we reported top line results from an open-label Phase IIa study with SPN817 in patients with treatment-resistant seizures. The study suggested a differentiated profile with strong efficacy in focal seizures at the 3 mg to 4 mg twice-daily doses. SPN817 was safe and had acceptable tolerability with two subjects discontinuing because of treatment-related adverse events out of the 26 subjects who entered the maintenance period. Stage B of the Phase IIa study is ongoing and includes the concomitant use of an anti-emetic to reduce cholinergic adverse events observed in the study. The company has initiated a Phase IIb randomized double-blind placebo-controlled study of 3 mg and 4 mg twice daily doses of SPN817, targeting enrollment of approximately 258 adult patients with treatment-resistant focal seizures. Also, the company completed a pharmacokinetics study of two oral formulations of SPM443 in healthy adults. Both formulations of SPM443 showed adequate bioavailability and were well tolerated. SPM443 is our new stimulant-like product candidate for ADHD and other CNS disorders. We recently disclosed that the Phase IIb study of SPNA20 in adults with treatment-resistant depression did not demonstrate a statistically significant improvement on the primary and secondary endpoints versus placebo. The safety profile of SPNA20 in this study was consistent with previous clinical trials showing few adverse events. We continue to analyze the data and will update you when we reach a decision regarding the future steps for the program. Finally, corporate development will continue to be a top priority looking for strategic opportunities to further strengthen our future growth through additional 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 fourth quarter and full-year 2024 results, please refer to today's press release and 10K was filed earlier today. Total revenue for the fourth quarter of 2024 was $174.2 million compared to $164.3 million in the same quarter last year. Total revenue in the fourth quarter of 2024 was comprised of net product sales of $166.4 million and royalty, licensing, and other revenues of $7.8 million. The increase in net product sales was primarily due to the increase in net product sales of our core products, Calgary and GoCovery. Excluding net product sales of Tritendi XR and Xtellar XR, total revenues for the fourth quarter of 2024 increased 29% compared to the same quarter of last year. For the fourth quarter of 2024, combined R&D and SG&A expenses for $108.1 million as compared to 104.6 million for the same quarter last year. Operating earnings on a gap basis for the fourth quarter of 2024 were 21.4 million as compared to an operating loss of 1 million for the same quarter last year. Recall during the fourth quarter of 2023, we booked a 20.2 million intangible asset impairment charge, reflecting the forthcoming loss of exclusivity of Zadago in December of 2027. Gap net earnings was $15.3 million for the fourth quarter of 2024, or $0.27 per diluted share, compared to gap net earnings of $1.2 million, or $0.02 per diluted share, in the same quarter last year. On a non-gap basis, which excludes amortization intangibles, share-based compensation, contingent consideration, impairment charges, and depreciation, adjusted operating earnings for the fourth quarter of 2024 was $48.3 million compared to $47.1 million in the same quarter of last year. Total revenues for the full year 2024 were $661.8 million compared to $607.5 million in the same period last year. Total revenues were comprised of net product sales of $637.7 million and royalty, licensing, and other revenues of $24.1 million. The 11% increase in net product sales was primarily due to the increase in net product sales of our core products, Calvary and GoCalvary. Excluding net product sales for Trekendi XR and Extellar XR, total revenues for the full year 2024 increased 25% compared to last year. Combined R&D and SG&E expenses for the full year 2024 were $430.4 million as compared to $428 million for the same period last year. Operating earnings on a gap basis for the full year 2024 were $81.7 million as compared to an operating loss of $5.3 million for the same period last year. The increase in operating earnings reflects the higher revenues and lower operating expenses in 2024. Gap net earnings were 73.9 million for the full year 2024, or $1.32 per diluted share, compared to 1.3 million, or 2 cents per diluted share, in the same period last year. On a non-gap basis, which again excludes amortization intangibles, Share based compensation, contingent consideration, impairment charges, and depreciation adjusted operating earnings was $183.7 million compared to $125.1 million in the same period. This is an approximately 47% increase year over year. As of December 31, 2024, the company had approximately $454 million in cash cash equivalents, and marketable securities, compared to $271 million as of December 31, 2023. This increase was primarily due to cash generated from operations. It should be noted that we have generated approximately $300 million in cash from operations in the past two years. Because of that, the company has a strong balance sheet with no debt, with significant financial flexibility, for potential M&A and other growth opportunities. Now turning to guidance. For four-year 2025, we expect total revenues to range from $600 million to $630 million, comprised of net product sales and royalty and licensing revenues. Note that total revenue guidance for four-year 2025 assumes approximately $65 million to $75 million of combined net sales of Triketi XR and our stellar XR. For the full year 2025, we expect combined R&D and SG&A expenses to range from $435 million to $460 million. Overall, we expect full year 2025 operating earnings in the range of $10 million to an operating loss of $15 million. And finally, we expect non-GAAP operating earnings to range from $105 million to $130 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?

Thank you. At this time, we will conduct a 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 at Jefferies. Your line is open.

Hey, thanks for taking my questions. Good afternoon. Congrats on the nice quarter. A couple of questions to start. if we backed out other products from your 2025 revenue guidance with reasonable assumptions, is it fair to infer maybe you're thinking Calgary this year could do maybe somewhere around 265 to 295? Is that a fair range or are you thinking something different? And then secondly, what do you think are the key levers to sales growth this year? Is it more TRX or is it more price or is it both? Thank you.

Yeah, hi, Andrew.

Regarding the range, it is a fair range. We try not to give guidance by product, but you could back into something like this. As far as the key levers for this year, there's certainly continued prescription growth. As we've seen, we've been very pleased with the performance of the product. As I mentioned in my prepared remarks, Q4 carried a lot of the momentum from the back-to-school season and set us up in a very nice way to start in a nice place for 2025. So we're certainly looking forward for more prescription growth. The market grew by 9%. We grew by 25% last year. And we still have a long way to go here. As I mentioned, you know, the market is now at 103 million prescriptions a year. We're only at 767,000 prescriptions in 2024. So we still have a lot of penetration that we can, you know, accomplish clearly with the product. And the basics of the product are still very, very solid. What I'm referring to is really satisfaction by patients. The very important segment, for example, adult segment, the patient satisfaction is very high. It's around 80%. To give you a little bit of reference, it's only 53% for Sveter. And to have, you know, a very nice high satisfaction rate for a non-stimulant in the adult population, that's really pretty strong. We all know adults love their stimulants, so for a non-stimulant to have that level of satisfaction. So we're very encouraged by a lot of the metrics behind the product, and therefore looking forward to another hopefully strong year on Calgary.

Great. And then as we think about your pipeline after SPN 820's TRD data, how does your BD appetite change now, if at all? And can you remind us the latest and greatest on how much firepower you have now? Thank you.

From a pipeline perspective, I mean, the first thing is just to clarify, 820 is not terminated. Otherwise, we would have said that in the press release. So that remains to be seen, and we'll see what the next steps will be. And certainly we'll communicate that, you know, as far as to what decisions we make. But aside from that, our BD activities will continue to be a top priority at the company, looking for, from a priority perspective, first commercial products, if we can bring in more revenue-generating products. And then next priority would be things that are more in the mid-stage to late-stage pipeline assets. And then from a therapeutic perspective, we're agnostic of whether it's psychiatry or neurology. We're pretty flexible there. And we're even open to other therapeutic areas, as I may have mentioned in the past in certain remarks, you know, that we've actually participated in certain processes and looking at assets outside CNS, as long as the situation involves, you know, multiple assets, not just one asset in a whole new therapeutic area. But if there is some scale, there is multiple assets, we would be interested in also expanding beyond just CNS. So it is a top priority, and as Tim mentioned earlier, we do have significant flexibility, clearly, given that our balance sheet is fairly clean. We have no debt. We have a strong cash position that we continue to add to. As far as the size, per se, it really depends on the situation itself. I mean, you could go pretty big if a certain situation brings in its own cash flows that will help us and will support a leveraging situation. So that in total could range from $500 to $1 billion, $1.5 billion. I mean, depending on the situation and the cash generation by the target that we're looking at.

Thanks so much. Appreciate it. Our next question comes from Stacy Ku at TD Cohen.

Your line is open.

Thanks so much for taking our questions and congratulations on the progress. First question is on Calgary. That performance in Q4, can you just walk through the variables driving strong pricing, especially as kind of 2025, just help us understand what you're thinking about gross net this year. And then a second follow-up on Calgary, Can you just talk about how the adult launch is progressing? And then second question is on SPN 820. Are you able to kind of give some idea of the timing of your strategic conclusions? Do you plan to make a decision this year? And then for the third question, for the Onopago launch, how should we think about the trajectory? What needs to be done to be ready? And are there any sales expectations embedded into 2025 guidance? Thanks so much.

Yeah, I'll try to take them in the same order. So on Calibri, we had certainly a very strong quarter, you know, in the fourth quarter, as I mentioned, you know, a big portion of that is clearly the prescription growth. So we grew by 11% sequentially. As far as the gross net, it really you know, as related to the pricing portion of that question, it really didn't change much. So the gross to net on Calgary has been fairly stable now in the last three quarters on the lower side of the range. So that now will it change in 25? Absolutely. I mean, cleaning Q1 is always, as we always know in this business in general, Calgary or no Calgary across all the industries. Q1 will be worse from a gross to net perspective because of the increase in the copay costs as we improve the benefits to help patients, you know, through the deductibles and so forth. So for the full year of 2025, probably the gross to net is going to be more in the 50 to 55%. That would be my guess at this point. And that's the same range we had talked about that in November of last year when we talked about the growth standard. Regarding the second question you have on the adult launch, I mean, we're pretty pleased, as I referred earlier, as far as performance of the product with adults, our efforts in the adult segment across male and female patient populations. You know, the product continues to perform really well. We do see more combination type of use in the adult patient population, meaning physicians are adding Calvary to the existing stimulant that adults are on. And over time, they tend to reduce the stimulant dose and increase the Calvary dose. With the ultimate goal, of course, is to take the patients off the stimulant completely. But they try not to do that abruptly from day one. because adults love the stimulants and they don't want to have the withdrawal effect from it sometimes as well. So they add Calgary gradually over time. And because of that, we see the combination use within the adult population, somewhere around the 35 to 40% of the prescriptions we believe are combination use with stimulants. Not as much in the pediatric side. On the pediatric side, we think that's more in the 15 to 20% this combination use. So we're still very, you know, encouraged by adult and we continue to push forward because the need is tremendous out there. And we are strong believers that people really don't have to be on controlled substances. I mean, if you have a non-stimulant that really works, whether you're an adult or a child, there is no reason for you to get on a stimulant from day one. You could always get on a stimulant later on if your non-stimulant doesn't work. But with KELRI, what we've seen time after time, and now the product's been on the market for three and a half years or close to four years, we see that the product really works within a week or two and works pretty well across the subscales. And people are pretty happy. As I mentioned, satisfaction in the adult population is fairly strong, around 80%. We're very optimistic about the potential in adults, especially given the importance of that segment in the marketplace.

If I could just quickly follow up, what share are you at for the adult segment right now in ADHD for Calvary? What's the split?

The share of Calgary of the total ADHD market, we're closing in on 1%.

Sorry, I apologize. The flip, which is of the Calgary launches, of the Calgary prescriptions, what percentage is adult right now?

Yeah, adults are in the 30% to 32%. It bounces around, you know, a quarter or depending on the seasonality. So it's basically the reverse of how the market splits. If you remember, the market is about 33% pediatric and 67% adult. So we still have a lot of room where we can, you know, grow in the adult side.

Understood. And I apologize. And now for SBN 820 and timing.

Yeah, sure. So moving on SBN 820, regarding the timing of what the next steps would be, we sure hope, you know, to do that in the next couple months. I don't know, could we do it earlier? We'll see, but certainly it wouldn't be this year, you know, as related to your question, and we'll do it as early as we can. We do think potentially we know what could be behind the results. We have looked at, you know, cross We looked at different sub-analyses, patient populations, different things. We couldn't see anything really that sticks out that, you know, have resulted, you know, with the result that we issued. But theoretically, there is a good reason to believe that potentially the dosing regimen is what's behind the different results that we got in the placebo-controlled study versus the open-label study. So we will be digging deeper into that aspect of it and see from a biologic perspective what the rationale is. There is a theory out there that maybe you don't need to hit the mTORC1 system frequently every single day. And actually intermittent dosing is needed or required for the system to function very well and to regulate depressive symptoms. and therefore intermittent dosing is probably more suitable than frequent every single day, you know, type of dosing, which was the case in the CHASE-2V study. So much more to be investigated at this point. We'll continue to analyze the data, and we'll come back and communicate that as soon as possible. And then I believe the last question was regarding on NAPCO. If I answered, you know, heard it right,

Yep, that's correct.

Yeah, so could you go ahead and repeat the question if you don't mind?

Yeah, so just help us understand the trajectory of the launch, what needs to be done to be ready, and if there are any sales expectations embedded into guidance.

Oh, okay. Yeah, sure. Yeah, the trajectory of the launch, I mean, we've said all along, you know, it will probably be a slow build. Now, however, having said that, We also know that a lot of KOLs have been waiting for this product, and we may. We may have a bolus of patients who may come in at the beginning, and then it will start going back to a more normal, slower rate. So all that remains to be seen. That is a possibility out there, but it remains to be seen. As far as our guidance, to be even more specific, I mean, we don't have really a lot in the guidance for ConectGo. It's really single-digit number, mid to a little bit high single-digit, so it's not really much as far as this year's guidance.

Thank you so much. Our next question comes from Annabel Simimi at Stifel.

Hi, this is Jack on for Annabelle. Thanks for taking your questions. So now that you have a NAPCO approved with the label specifically for severe patients, do you have a better sense of what your market will be and who might the low-hanging fruit be for an apomorphine pump versus a levodopa carbidopa pump? And could you remind us again how all of your PD products now fit together? Do you expect the pump to partially cannibalize the opportunity for apokine at all? And where does GoCobre fit in with the rest?

Yes, sure. And the label for Onepco says advanced Parkinson's disease. And as you would probably expect, I mean, the definition of advanced by a lot of KOLs might vary between, you know, what they consider advanced. For some KOLs, advanced maybe could mean that I have a patient been diagnosed now 10 years ago, They've tried a lot of agents out there, a lot of the oral adjunctive therapy with libidopa, carbidopa, and they're getting to a point where maybe they need deep brain stimulation or some other invasive surgery product and so forth. And that could be a candidate and would be a candidate for an APCO. Another KOL might say, you know what, I've had a patient who's only been diagnosed three or four years ago, but really struggling with all the oral agents out there, and therefore I might want to try the pump. So all this remains to be seen clearly. Everything we do, promotional and everything, will be centered around the advanced patients. And as far as the interaction or the overlap, if you want to say, between Onepco and potentially Apokin, just to clarify, Onepco is really providing you with all-day continuous infusion of apomorphine, and it is for all-day control. However, Apokin is more for acute episodes, single injection for acute episodes. So there is a very distinct positioning clearly and uses for these two products. Now, we have said in the past that potentially there might be some overlap or some cannibalization of Apokin, In case you have patients, for example, who might be taking multiple injections of aprican during a certain day, they may choose to try the pump. I mean, there is a possibility, but clearly from our perspective, the two products are separate. Aprican indication is for acute treatment, you know, single injection. Obviously, the pump is more for an all-day control with a continuous infusion of apomorphine. And generally speaking, apomorphine is really a great drug, and it really differentiates significantly from, first of all, the oral dopamine agonist. It is very much like dopamine. It acts like dopamine. It actually have, you know, one of the best receptor, you know, binding profile and affinity to all, you know, the D1 through D5 receptors. Unlike some of the oral dopamine agonists, they don't have affinity to the D1 family. So, apomorphine actually is very much like dopamine. And also, when it gets through the system, it doesn't need to be converted to dopamine. So, it acts directly on the, you know, D1, D2 family receptors. So, that's a great drug. And it really differentiates versus, you know, even Libidopa itself. Because levodopa, even after it gets absorbed, it has to be converted to dopamine, where apomorphine actually doesn't need to have that conversion. And therefore, you don't need the neurons to convert apomorphine to dopamine so that it can get to the postsynaptic neurons. So all in all, we think, you know, the drug will differentiate very well, and there will be a great, you know, mean for Onecto. It has a great clinical profile as well as tolerability. You know, people ask me the question, how does it compare to the other pumps that got approved? Clearly, people, you know, I will let people read the labels and make their own decision as to, you know, how they compare.

Great. Thank you. Sure.

Our next question comes from David Amsalam at Piper Sandler.

Thanks. Just a couple for me. So first on ADHD and Calvary specifically, how are you thinking about the competitive landscape to the extent that others non-stimulants enter the market? We're going to get a data readout for psori-amphetol in adult patients, for instance, in the not-too-distant future. So how are you thinking about competitive landscape, not just in terms of volumes, but how that might impact the payer landscapes and your gross tenets going forward? So that's number one. And then number two, sorry if I missed this, but have you announced pricing for an APCO? And if you haven't, can you tell us where you think it could be just as a point of reference relative to Vialiv, Abdi's Vialiv? Thanks.

Yeah, regarding ADC and the competitive landscape, it's really very hard for us to make any comments at this point until we see the labels or even first before labels, the data from these products. So We really don't have and haven't seen any, you know, phase three data. So that remains to be seen as far as whether these products will be competitive, actually, you know, versus Calgary and so forth. So that remains to be seen on both products, you know, the two products that are out there and currently in development. And whether that will impact the payer landscape or not, you know, we tend to be very disciplined, as you guys know, when it comes to payers. So we will do what we believe is right for Calgary. We know that Calgary brings an incredible differentiation in the marketplace. We have a significant head start, clearly, in the non-stimulant. And it has been the first novel non-stimulant in decades, you know, introduced in this category. And we've been able to, you know, have a very good payout strategy. across four, and we're very pleased with the coverage that the product has today and in the foreseeable future. Finally, on the price of Onepto, it is public at this point. I mean, we priced it within a very good range. Clearly, that is competitive in the marketplace.

That's all I can say on that.

Okay, thanks. Our next question comes from Kristen Kluska at Kent or Fitzgerald.

Hey, everyone. Congrats on a great quarter. Given you've been following the ADHD patients for a while, can you comment on roughly what percent of them do you believe have comorbidities that are potentially on two plus drugs to address both the ADHD and other conditions? how you're now thinking about penetrating more into that space now that the FDA has acknowledged this in your label, although I know you've been believing in this and talking about the data and have had anecdotes from physicians in the past.

Yes. ADHD is very well known to have significant comorbidities across board. A lot of it are mood disorders, such as depression, anxiety, even bipolar, and so forth. As far as the percentages, they do range, you know, from, we've seen numbers from the, as many as 40 to even 60 percent of ADHD patients that have a lot of these comorbidities. They do tend to be an issue for a lot of patients out there because actually stimulants are kind of contraindicated for a lot of these mood disorders because they tend to exacerbate, you know, these issues. And that's why, you know, a lot of the adults or some of the adults are on non-stimulants for that reason. We are certainly, as I mentioned in my prepared remarks, we're certainly pleased with the fact that it is now acknowledged that Veloxazine is very different than ethylmoxidine. It does have a very unique mechanism of action. It is a multimodal pharmacodynamic, you know, activity that happens with Velocisane, specifically on the serotonin. And that's really what has separated the molecule for actually years or decades from strata that had failed actually in clinical trials in treating certain mood disorders. Now, that is something we cannot promote. We will not promote, and we will not talk about any other indications for Calgary other than what's on the label, clearly. But it was a very important scientific information that physicians have been looking for since, you know, actually the day we've been developing Calgary, because they have seen certain things in the clinical studies, and they would like to know clearly around the serotonin because, They do use other products that also could have serotonin activity, and we need to inform physicians about that because they worry about serotonin syndrome and all kinds of things from a safety perspective. So we're very pleased to see that change in the label to better inform physicians on the activity of the drug in general. And clearly we are very also encouraged by the open label study that I talked about, which is an ADHD and comorbid disorders, mood disorders. So we encourage folks to look at the publication of the poster at the conference in May.

Okay, thank you for that. And then on the BD front, can you talk about, you know, I know you had some comments on it before, but just therapeutic areas and spaces that you think are really promising and you can kind of leverage some of your in-house capabilities that you've been working on in the past?

Yeah, I mean, we look for areas that are, I mean, they don't have to be necessarily adjacent to CNS or synergistic with CNS. They could be on their own as long as that situation has some scale to it. So we won't be as interested in something completely new with only one product because then it puts more pressure to try to look and build around that one product and find other products or product candidates, pipeline assets that can help you build that scale in this new therapeutic area. So preference would be if we were to enter a new area, hopefully from day one we could find something that could be a multi-asset situation, whether it's commercial, pipeline, a mix of both, that will allow us to bring in the scale and the efficiency and the operation from R&D all the way into commercial execution. So that's how we think about it, and it doesn't really matter whether, and I'm just going to throw out examples, it doesn't mean that's what we're looking at, but whether it's dermatology, ophthalmology, urology, any of these specialty areas where we can be very efficient and effective with a reasonable small sales force effort behind it. In addition to that, we have a really good infrastructure to deal with rare disease and orphan diseases. We are very well set up, especially, for example, in the Parkinson area, you know, where we have a very strong infrastructure to support rare orphan diseases. So those would be also areas that we would be interested in.

Thank you, Jack.

I'm showing no further questions at this time. I would now like to turn it back to Jack for closing remarks.

Thank you. In concluding our call this afternoon, we thank you for joining us to learn about our strong operating performance in the fourth quarter and full year 2024. The company has executed well through a multi-year transition and the loss of exclusivity on two of its legacy products. Excluding our legacy products, we continue to deliver robust double-digit growth in revenues. The company continues to generate also strong cash flows behind the strength of its portfolio, particularly its core products, and through the efficiency of its operations. As a result, and as we mentioned earlier, we finished the year in a position of financial strength with $454 million of cash on the balance sheet at no debt. We believe we are well positioned for continued growth beyond the current transition and our focus on several key areas. First, driving growth and generating strong cash flow from our core products, particularly Calgary, allowing us to continue our investments in our pipeline. Second, the launch of Enacto in the second quarter of this year. And third, advancing our innovative R&D portfolio of differentiated first-in-class models. Finally, corporate development will continue to be a top priority to augment our growth to external opportunities. Thanks again for joining us this afternoon. We look forward to updating you on our next call.

Thank you. For your participation in today's conference, this does conclude the program. You may now disconnect.