Q4 2024 Supernus Pharmaceuticals Inc Earnings Call

February 25, 2025

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Speaker Change: Good afternoon, and welcome to Supernova 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.

Speaker Change: As a reminder, this conference call is being recorded. I would now like to turn the conference over to Peter Vozzo of ICR Healthcare, Investor Relations Representative for Sopernes Pharmaceuticals. You may begin.

Speaker Change: Thank you, Jacinda. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' fourth quarter and full year 2024 financial results conference call.

Peter Vozzo: Today, after the close of a market, the company issued a press release announcing these results. On the call with me today are Supertas' Chief Executive Officer, Jack Khattar, and Chief Financial Officer, Tim Dec.

Peter Vozzo: Today's call will be made available via the investment relations section of the company's website at IR.Sopernis.com

Peter Vozzo: During the course of this call, management may make certain forward-looking statements regarding future events and the company's future performance.

Peter Vozzo: These forward-looking statements reflect Superntis' 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 files.

Peter Vozzo: Actual results may differ materially from those projected in these four different statements.

Peter Vozzo: For the benefit of those of you who may be listening to the replay, this call was being held and recorded on February 25, 2025.

Speaker Change: Since then, the company may have made additional announcements related to the topics discussed. He has referenced the company's most recent press releases and current filings with the FTC, supported the client in the obligation to update these forward-looking statements, except as required by applicable securities laws. I'll now turn the call over to Dan.

Dan: Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us on today's call.

Dan: Our 2024 results reflect solid commercial execution across the company, including continued growth of our core products and strong growth in operating earnings.

Dan: Our performance in 2024 underscored our emphasis on growing our core business despite the loss of exclusivity on both Tropendi XO Argonauts and Stellar XO.

Dan: Total revenues excluding propandic sod and oxalate sod increased by 25% for the full year 2024.

Dan: Driving this growth was Calgary's robust performance with 25% growth in annual prescriptions as reported by IQVIA and 72% growth in annual net sales.

Dan: In 2024, Calgary's annual prescription growth outpaced that of the ADHD market that grew by 9%, reaching 103 million prescriptions.

Dan: Calgary's back-to-school momentum carried through the fourth quarter with sequential prescription growth of 11% compared to the third quarter.

Dan: 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.

Dan: In 2025, Calgary is off to a good start with exciting news about the NFPA approval of its updated label.

Dan: The new label further elaborates and differentiates Calbee's mechanism of action as a novel non-stimulant.

Dan: reinforcing its multimodal pharmacodynamic profile and highlighting its unique partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the onorepinephrine transport.

Dan: 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.

Dan: In addition, earlier this month at the annual National Psychopharmacology Update Conference, Sopranos presented interim results from an open-label Phase 4 trial with Calvary in adult patients with ADHD and mood disorders.

Dan: 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.

Dan: The data are encouraging and suggest that the effects of Calgary may extend to adults with complex ADHD.

Dan: The safety outcomes in the trial were consistent with the double blind pivotal trial of Kelby in adult ADHD.

Dan: Full results from all the 161 adult patients who 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.

Dan: 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.

Dan: This extends the original expiration date of that pattern to the year 2035.

Dan: 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.

Dan: Earlier this month, the FDA approved Onapto, Superna's next growth product. It is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson's disease.

Dan: We are targeting the launch of Onamco in the second quarter of 2025 with a support team of experts including a nurse education program and access support.

Dan: Onamco fits very well within our portfolio as it utilizes our existing Parkinson's disease sales force and infrastructure.

Dan: Switching to our legacy products, the first genetic for Oxthelix R entered the market in early September 2024, resulting in both a year-over-year and sequential quarter-to-quarter decline in net sales of Oxthelix R.

Dan: in the fourth quarter 2024. For full year 2024 combined, net sales of Trocandier XR and Ostellar XR were down 22%.

Dan: In 2025, we expect further erosion and both product sales would combine net sales to be in the range of $65 million to $75 million.

Dan: Moving on to our CNS pipeline of novel product candidates. In November 2024, we reported top-line results from an open-label phase 2a study with SPNA-217 in patients with treatment-resistant seizures.

Dan: The study suggested a differentiated profile with strong efficacy in focal cedars at the 3mg to 4mg twice daily doses.

Dan: SPN 817 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.

Dan: Stage B of the Phase IIa study is ongoing and includes the concomitant use of an anti-emetic to reduce cardiac adverse events observed in the study.

Dan: The company has initiated a Phase IIb randomized double-blind placebo-controlled study of 3mg and 4mg twice daily doses of SPN817, targeting enrollment of approximately 258 adult patients with treatment-resistant focal seizures.

Dan: Also, the company completed a pharmacokinetic study of two oral formulations of SPM443 in healthy adults.

Dan: Both formulations of SPM443 show adequate bioavailability and were well tolerated. SPM443 is our new stimulant-like product candidate for ADHD and other CNS disorders.

Dan: 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.

Tim Dec: 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.

Tim Dec: 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 10-K was filed earlier today.

Tim Dec: Total revenue for the fourth quarter of 2024 was $174.2 million compared to $164.3 million in the same quarter last year.

Tim Dec: 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.

Tim Dec: The increase in net product sales was primarily due to the increase in net product sales of our core products, Calgary and GoCalgary.

Tim Dec: excluding net product sales of Tritendi XR and Extellar XR, total revenues for the fourth quarter of 2024 increased 29% compared to the same quarter last year.

Tim Dec: For the fourth quarter of 2024, combined RMD and SG&A expenses were $108.1 million, as compared to $104.6 million for the same quarter last year.

Tim Dec: 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.

Tim Dec: Recall, during the fourth quarter of 2023, we booked a $20.2 million intangible asset impairment charge.

Tim Dec: reflecting the forthcoming loss of exclusivity of Zadago in December of 2027.

Tim Dec: 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-GAAP basis, which excludes amortization intangibles.

Tim Dec: Share-based compensation, contingent consideration, impairment charges, and appreciation 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.

Tim Dec: Total revenues for the full year 2024 were $661.8 million compared to $607.5 million in the same period last year.

Tim Dec: Total revenues were comprised of net product sales of $637.7 million and royalty, licensing, and other revenues of $24.1 million.

Tim Dec: The 11% increase in Net Product Sales was primarily due to the increase in Net Product Sales of our core products, Calgary and GoCountry.

Tim Dec: Excluding net product sales for Tricendi XR and Extended Excellent, total revenues for full year 2024 increased 25% compared to last year.

Tim Dec: Combined R&D and SG&A expenses for the full year 2024 were $430.4 million as compared to $428 million for the same period last year.

Tim Dec: 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.

Tim Dec: The increase in operating earnings reflects the higher revenues and lower operating expenses in 2024.

Tim Dec: Gap net earnings were $73.9 million for the full year 2024, or $1.32 per diluted share, compared to $1.3 million, or $0.02 per diluted share, in the same period last year.

Tim Dec: On a non-GAAP basis, which again excludes amortization intangibles, share-based compensation, continued consideration, impairment charges, and depreciation, adjusted operating rates was $183.7 million compared to $125.1 million in the same period.

This is an approximately 47% increase year-over-year.

Tim Dec: As of Dec. 31, 2024, the company had approximately $454 million in cash, cash equivalents, and marketable securities, compared to $271 million as of Dec. 31, 2023. This increase was primarily due to cash generated from operations.

Tim Dec: It should be noted that we have generated approximately $300 million in cash from operations in the past two years.

Tim Dec: 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.

Tim Dec: 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.

Tim Dec: Note that Total Revenue Guidance for the full year 2025 assumes approximately $65 million to $75 million of combined net sales on Trichetti XR and on Stellar XR.

Tim Dec: For the full year 2025, we expect combined R&D and SG&A expenses to range from $435 million to $460 million.

Tim Dec: Overall, we expect full year 2025 operating earnings in the range of $10 million to an operating loss of $15 million.

Tim Dec: And finally, we expect non-GAAP operating range to range from 100 to 5 million to 130 million.

Tim Dec: Please refer to the Art Express release issued prior to this call that identifies the various ranges of reconciling items between GAP and non-GAP.

Tim Dec: With that, I will now turn the call back over to the operator for Q&A.

Thank you. Thank you.

Tim Dec: 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 one one on your telephone and wait for your name to be announced.

Tim Dec: To withdraw your question, please press star 1 1 again. Please stand by while we compile the Q&A roster.

Speaker Change: Our first question comes from Andrew Tassai at Jeffries. Your line is open.

Andrew Tassai: 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.

Andrew Tassai: 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.

And regarding the range, it is a fair range.

Andrew Tassai: We try not to give guidance by product, but you could back into something like this.

Andrew Tassai: As far as the key levels for this year, there's certainly continued prescription growth.

Andrew Tassai: 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.

Andrew Tassai: and, you know, 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.

Andrew Tassai: The market grew by 9%, we grew by 25% last year.

Andrew Tassai: We still have a lot of penetration that we can accomplish clearly with the product.

Andrew Tassai: And the basics of the product are still very, very solid. What I'm referring to is really satisfaction by patients.

Andrew Tassai: 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% postpartum.

Andrew Tassai: And to have, you know, a very nice, high satisfaction rate for a non-stimulant in the adult population, that that's really...

Andrew Tassai: 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.

Andrew Tassai: and therefore looking forward to another hopefully strong year on Galbraith.

Speaker Change: 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.

Speaker Change: 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.

Speaker Change: But aside from that, our BD activities will continue to be top priority at the company, looking for, from a priority perspective, first commercial products, if we can bring in more revenue generating products.

Speaker Change: And then next priority would be things that are more in the mid-stage to late-stage pipeline assets.

Speaker Change: 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.

Speaker Change: symptom processes and looking at assets outside CNS, as long as the situation involves.

Speaker Change: you know, multiple assets, not just one asset in a whole new therapeutic areas. But if there is some scale, there is multiple assets, we would be interested in also expanding beyond just CNS.

Speaker Change: 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.

Speaker Change: As far as the size per se, it really depends on the situation itself.

Speaker Change: brings in its own cash flows that will help us and will support a leveraging you know leveraging situation so

Speaker Change: So that in total could range from 500 to a billion, a billion and a half, I mean, depending on the situation and the cash generation by, you know, the target that we're looking at. Thanks so much. Appreciate it.

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Speaker Change: Our next question comes from Stacy Kuh at TD Cohen. Your line is open.

Stacy Kuh: Thanks so much for taking our questions and congratulations on the progress. Um, first question is on Calvary, 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 growth next year.

Speaker Change: And then a second follow-up on Calgary, can you just talk about how the adult launch is progressing?

Speaker Change: And then a 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...

Speaker Change: for the Anapago 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.

Speaker Change: Yeah, I'll try to take them in the same order. So, uncalibrate...

Speaker Change: 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.

Speaker Change: as related to the pricing portion of that question. It really didn't change much. So the gross net on Calgary has been fairly stable now in the last three quarters.

Speaker Change: on the lower side of the range. Now, will it change in 2025? Absolutely. I mean, clearly Q1 is always, as we always know in this business in general, Calgary or no Calgary across all the industry. Q1 will be worse from a gross net perspective because of the increase in the co-pay costs.

Speaker Change: as we improve the benefits to health patients through the deductibles and so forth.

So, for the full year of 2025,

Speaker Change: Probably the gross net is going to be more in the 50 to 55 percent. That would be my guess at this point. And that's the same range we had talked about back in November of last year when we talked about the gross net.

Speaker Change: 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.

Thank you.

You know, the product continues to perform really well.

Speaker Change: We do see more combination type of use in the adult patient population, meaning physicians are adding Calbree to the existing stimulant that adults are on, and over time they tend to reduce the stimulant dose

Speaker Change: and increase the calorie dose, with the ultimate goal, of course, is to take the patients off the stimulant completely.

Speaker Change: But they try not to do that abruptly from day one.

Speaker Change: because adults love the stimulants and they don't want to have the withdrawal effect from it sometimes as well.

Speaker Change: 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 a combination use with stimulants.

Speaker Change: Not as much in the pediatric side. On the pediatric side, we think that's more in the...

Speaker Change: 15 to 20 percent 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...

Speaker Change: 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...

Speaker Change: There is no reason for you to get on a stimulant from day one. You can always get on a stimulant later on if your lung stimulant doesn't work. But with Calvary, 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.

Speaker Change: We see that the product really works within a week or two.

Speaker Change: 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 percent. So we're very optimistic about the potential in adults, especially given the importance of that segment in the marketplace.

Speaker Change: If I could just quickly follow-up, what share are you at for the adult segment right now in ADHD for Calbary with the split?

Speaker Change: I apologize, the flip, which is, of the Calgary launches, of the Calgary prescriptions, what percentage is adult right now?

Speaker Change: Yeah, it bounces in the 30 to 32 percent. 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 percent pediatric and 67 percent adult.

Speaker Change: So we still have a lot of room where we can, you know, grow in the adult sector.

Speaker Change: 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 to do that in the next.

Speaker Change: in a couple of months. I don't know. Could we do it earlier? We'll see. But certainly it wouldn't be this year, you know, as it related to your question.

Speaker Change: We do think, potentially, we know what could be behind the results. We have looked at

You know cross

Speaker Change: We couldn't see anything really that sticks out that, you know, have resulted, you know, with the result that we issued, but...

Speaker Change: Theoretically, there is a good reason to believe that actually the dosing regimen is what's behind the different results that we got in the placebo-controlled study versus the open-label study.

Speaker Change: So we will be digging deeper into that aspect of it and see from a biologic perspective.

Speaker Change: What the rationale is, there is a theory out there that maybe you don't need to hit the mtorq1 system frequently every single day.

Speaker Change: And actually intermittent dosing is needed or required for the system to function very well and to regulate, you know, depressive symptoms.

Speaker Change: And therefore, intermittent dosing is probably more suitable than frequent, every single day, you know, type of dosing, which was the case in the Phase IIb study.

Speaker Change: 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.

Speaker Change: And then I believe the last question was regarding on NETCO. Is it if I answer, you know, go to the right?

Yep, that's correct.

Yeah, so.

Speaker Change: 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 the guidance. Oh, okay. Yeah, sure.

Speaker Change: 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 have a bolus of patients who may come in at the beginning

Speaker Change: and then it will start going back to a more normal slower rate. So that all that remains to be seen. That is a possibility out there but it remains to be seen.

Speaker Change: As far as our guidance, to be even more specific, I mean, we don't have really a lot in the guidance for Conneco. 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.

Thank you so much.

Our next question comes from Annabelle Simamee at STFL.

Speaker Change: Hi, this is Jack on for Annabelle. Thanks for taking our 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?

Speaker Change: 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 apican at all? And where does Gokavri fit in with the rest?

Speaker Change: Yes, sure. The label for Onefco says advanced Parkinson's disease and

Speaker Change: As you would probably expect, I mean, the definition of advanced...

Speaker Change: Well, 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...

Speaker Change: been diagnosed now 10 years ago. They've tried a lot of agents out there, a lot of the oral adjunctus therapy with levodopa, carbidopa, and they're getting to a point where

Speaker Change: Maybe they need deep brain stimulation or some other invasive, you know, surgery product and so forth. And that could be a candidate and would be a candidate for a NAPCO. Another KOL might say, you know what?

Speaker Change: I've had a patient who's only been diagnosed three or four years ago, but

Speaker Change: 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.

Speaker Change: Everything we do, promotional and everything, will be centered around advanced patients.

Speaker Change: and as far as the interaction or the overlap, if you want to say, between Onapko and potentially Apokin.

Speaker Change: Just to clarify, Onefco is really providing you with all-day continuous infusion of apomorphine, and it is for all-day control.

Speaker Change: 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 Apokin during a certain day.

Speaker Change: They may choose to try the pump. I mean, there is a possibility, but clearly, from our perspective, the two products are separate.

Speaker Change: Apocan indication is for acute treatment, single injection, obviously the pump is more for an all-day control with a continuous infusion of apomorphine. And generally speaking, apomorphine...

Speaker Change: is really a great drug, and it really differentiates significantly from, first of all, the oral dopamine agonist.

Speaker Change: It is very much like dopamine, it acts like dopamine, it actually has, you know, one of the best receptor.

Speaker Change: Dr. Peter Vozzo, Timothy Dec, Peter Vozzo, Timothy Dec, Peter Vozzo, Timothy Dec, Peter

Speaker Change: 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.

Speaker Change: So it's a great drug, and it really differentiates versus, you know, even levodopa 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.

Speaker Change: to convert apomorphine to dopamine so that it can get to the postsynaptic neurons.

Speaker Change: All in all, we think, you know, the drug will differentiate very well and there will be a great, you know, need for one after it has a great clinical profile as well as tolerability.

Speaker Change: 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.

Thank you.

Our next question comes from David Amsalom at Piper Sandler.

David Amsalom: Thanks, just a couple for me. So first on ADHD and Calgary specifically, how are you thinking about the competitive landscape to the extent that others non-stimulants enter the market? We're gonna get a data readout for psoriatic and adult patients.

David Amsalom: 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 in your gross donats going forward? So, that's number one.

David Amsalom: And then number two, sorry if I missed this, but have you announced pricing for a NAPCO? And if you haven't, can you tell us where you think it could be just as a point of reference relative to Vialev, AbbVie's Vialev? Thanks.

Thank you for watching!

Speaker Change: 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.

Speaker Change: We really don't have and haven't seen any, you know, Phase 3 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.

Speaker Change: 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.

Speaker Change: 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.

Speaker Change: 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 payoff strategy across Ford and we're very pleased, you know, with the coverage that the product has today and in the foreseeable future.

Speaker Change: Finally, on the price of Orneco, 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.

Thank you.

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Our next question comes from Kristen Kluska at Kenter Fitzgerald.

Kristen Kluska: 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

Kristen Kluska: are potentially on two-plus drugs to address both the ADHD and other conditions and 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 and

Kristen Kluska: to have significant comorbidities across board. A lot of it are mood disorders, such as depression, anxiety, even bipolar, and so forth.

Kristen Kluska: As far as the percentages, they do range, you know, from, we've seen numbers from as many as 40 to even 60% of ADHD patients that have a lot of these comorbidities.

Kristen Kluska: They do tend to be an issue for a lot of patients out there because actually stimulants are

Kristen Kluska: 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.

Speaker Change: We are certainly, as I mentioned in my prepared remarks, we were certainly pleased with the fact that

Speaker Change: It is now acknowledged that Veloxazine is very different than Ethoxazine.

Speaker Change: It does have a very unique mechanism of action. It is a multi-modal pharmacodynamic, you know, activity that happens with galactosane, specifically on the serotonin.

Speaker Change: And that's really what has separated the molecule for actually years or decades.

Speaker Change: from Satana that had failed, actually, in clinical trials in treating certain mood disorders.

Speaker Change: 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.

Speaker Change: 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.

Speaker Change: 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, you know, physicians on the activity of the drug in general.

Speaker Change: And clearly we are very also encouraged by the open-label study that I talked about, which is ADHD and comorbid disorders, mood disorders. So we encourage folks to look at the publication of the poster at the conference in May.

Speaker Change: 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.

Speaker Change: We look for areas that 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...

Speaker Change: 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.

Speaker Change: that can help you build to that scale in this new therapeutic area.

Speaker Change: 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.

Speaker Change: That will allow us to bring in the scale and the efficiency and the operation from R&D all the way into commercial execution.

Speaker Change: 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 salesforce effort behind it.

Speaker Change: In addition to that, we have a really good infrastructure to deal with rare diseases and orphan diseases.

Speaker Change: We're very well set up, especially, for example, in the Parkinson area, you know, where we have a very strong infrastructure to support rare or orphan diseases. So those would be also areas that we would be interested in.

Thank you, Jack.

Thank you. Bye.

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

Jack Khattar: 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.

Speaker Change: The company has executed well through a multi-year transition and the loss of exclusivity on two of its legacy products.

Speaker Change: Excluding our legacy products, we continue to deliver robust double-digit growth in revenues.

Speaker Change: The company continued to generate also strong cash flows behind the strength of its portfolio, particularly its core products, and to the efficiency of its operations.

Speaker Change: 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.

Speaker Change: 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.

Speaker Change: Second, the launch of Onacto in the second quarter of this year. And third, advancing our innovative R&D portfolio of differentiated first and last models.

Speaker Change: 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.

Speaker Change: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Speaker Change: This is a production of the Center for Contemporary Art in the United States of America. No part of this recording may be reproduced without the support of the Center for Contemporary Art in the United States of America.

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Speaker Change: Good afternoon, and welcome to SIPRNF Pharmaceutical's fourth quarter and full year 2024 Financial Results Conference call.

Speaker Change: 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.

Speaker Change: As a reminder, this conference call is being recorded. I would now like to turn the conference over to Peter Vozzo of IVR Healthcare, Investor Relations Representative for Sopranos Pharmaceuticals. You may begin.

Speaker Change: Thank you, Jacinda. Good afternoon everyone and thank you for joining us today for Supernus Pharmaceuticals fourth quarter and full year 2024 financial results conference call.

Speaker Change: Today, after the close of the market, the company issued a press release announcing these results. On the call with me today are Supertas' Chief Executive Officer, Jack Khattar, and Chief Financial Officer, Tim Dec.

Speaker Change: During the course of this call, management may make certain forward-looking statements regarding future events and the company's future performance.

Speaker Change: These forward-looking statements reflect Pernas' 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 files.

Speaker Change: Actual results may differ materially from those projected in these formative statements.

Speaker Change: For the benefit of those of you who may be listening to the replay, this call was being held and recorded on February 25, 2025.

Dan: Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us on today's call.

Dan: Our 2024 results reflect solid commercial execution across the company, including continued growth of our core products and strong growth in operating earnings.

Dan: Our performance in 2024 underscored our emphasis on growing our core business, despite the loss of exclusivity on both TropendiXR and on StellarXR.

Dan: Total revenues excluding propendics are on off-sellers are increased by 25% for the full year 2024.

Dan: Driving this growth was Calgary's robust performance with 25% growth in annual prescriptions as reported by IQVIA and 72% growth in annual net sales.

Dan: In 2024, Calgary's annual prescription growth outpaced that of the ADHD market that grew by 9%, reaching 103 million prescriptions.

Dan: Calgary's back-to-school momentum carried through the fourth quarter with sequential prescription growth of 11% compared to the third quarter.

Dan: 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.

Dan: In 2025, Calgary is off to a good start with exciting news about the NFTA approval of its updated label.

Dan: The new label further elaborates and differentiates Calbee's mechanism of action as a novel non-stimulant.

Dan: reinforcing its multimodal pharmacodynamic profile and highlighting its unique partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the online epinephrine transport.

Sopranus: In addition, earlier this month, at the annual National Psychopharmacology Update Conference, Sopranus presented interim results from an open-label Phase 4 trial with Calvary in adult patients with ADHD and mood disorders.

Sopranus: 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.

Sopranus: The data are encouraging and suggest that the effects of Calgary may extend to adults with complex ADHD.

Sopranus: The safety outcomes in the trial were consistent with the double blind pivotal trial of Kelby in adult ADHD.

Sopranus: That data will be presented at the American Psychiatric Association Annual Meeting in May of this year.

Sopranus: 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.

Sopranus: This extends the original expiration date of that pattern to the year 2035.

Sopranus: 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.

Sopranus: Earlier this month, the FDA approved Onapto, Superna's next growth product. It is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson's disease.

Sopranus: We are targeting the launch of Onamco in the second quarter of 2025 with a support team of experts including a nurse education program and access support.

Sopranus: Onamco fits very well within our portfolio as it utilizes our existing Parkinson's disease sales force and infrastructure.

Sopranus: Switching to our legacy products, the first genetic for Oxthelix R entered the market in early September 2024, resulting in both a year-over-year and sequential quarter-to-quarter decline in net sales of Oxthelix R.

Sopranus: in the fourth quarter 2024. For full year 2024 combined, net sales of Trocadier XR and Oxtella XR were down 22 percent.

Sopranus: In 2025, we expect further erosion and both product sales would combine net sales to be in the range of $65 million to $75 million.

Sopranus: Moving on to our CNS pipeline of novel product candidates. In November 2024, we reported top-line results from an open-label phase 2a study with SPN 817 in patients with treatment-resistant seizures.

Sopranus: The study suggested a differentiated profile with strong efficacy in focal cedars at the 3mg to 4mg twice daily doses.

Sopranus: SBN 817 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.

Sopranus: 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.

Sopranus: The company has initiated a Phase IIb randomized double-blind placebo-controlled study of 3mg and 4mg twice daily doses of SPN817, targeting enrollment of approximately 258 adult patients with treatment-resistant focal seizures.

Sopranus: Also, the company completed a pharmacokinetic study of two oral formulations of SPM443 in healthy adults.

Sopranus: 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.

Sopranus: We recently disclosed that the Phase IIb study of SPNA20 in adults with treatment-resistant depression does not demonstrate a statistically significant improvement on the primary and secondary endpoints versus placebo.

Sopranus: 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.

Sopranus: 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.

Tim Dec: With that, I will now turn the call over to Tim.

Tim Dec: 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 10-K was filed earlier today.

Tim Dec: Total revenue for the fourth quarter of 2024 was $174.2 million compared to $164.3 million in the same quarter last year.

Tim Dec: 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.

Tim Dec: The increase in net product sales was primarily due to the increase in net product sales on core products.

Calgary, and Montgomery.

Tim Dec: Excluding net product sales of Trucendi XR and Axtellar XR, total revenues for the fourth quarter of 2024 increased 29% compared to the same quarter of last year.

Tim Dec: For the fourth quarter of 2024, combined RMD and SGA expenses were $108.1 million, as compared to $104.6 million for the same quarter last year.

Tim Dec: 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.

Tim Dec: Recall, during the fourth quarter of 2023, we booked a $20.2 million intangible asset impairment charge.

Tim Dec: reflecting the forthcoming loss of exclusivity of Zadago in December of 2027.

Tim Dec: Gap net earnings was $15.3 million for the fourth quarter of 2024, or $0.27 per diluted share.

Tim Dec: 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.

Tim Dec: Total revenues for the full year 2024 were $661.8 million compared to $607.5 million in the same period last year.

Tim Dec: Total revenues were comprised of net product sales of $637.7 million and royalty, licensing, and other revenues of $24.1 million.

Tim Dec: The 11% increase in Net Product Sales was primarily due to the increase in Net Product Sales of our core products, Calgary and GoCalgary.

Tim Dec: Excluding net product sales for Kikendi XR and Extended Excellent, total revenues for full year 2024 increased 25% compared to last year.

Tim Dec: Combined R&D and SG&A expenses for the full year 2024 were $430.4 million as compared to $428 million for the same period last year.

Tim Dec: Operating earnings on a gap basis for the full year of 2024 were $81.7 million, as compared to an operating loss of $5.3 million for the same period last year.

Tim Dec: The increase in operating earnings reflects the higher revenues and lower operating expenses in 2024.

Tim Dec: Gap net earnings were $73.9 million for the full year 2024, or $1.32 per diluted share, compared to $1.3 million, or $0.02 per diluted share, in the same period last year.

Tim Dec: On a non-GAAP basis, which again excludes amortization intangibles, share-based compensation, continuing 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.

Tim Dec: As of Dec. 31, 2024, the company had approximately $454 million in cash, cash equivalents, and marketable securities, compared to $271 million as of Dec. 31, 2023.

This increase was primarily due to cash generated from operations.

Tim Dec: It should be noted that we have generated approximately $300 million in cash from operations in the past two years.

Now turning to guidance.

Tim Dec: For 4-year 2025, we expect total revenues to range from $600 million to $630 million, comprised of net product sales and royalty and licensing revenues.

Tim Dec: Note that total revenue guidance for the full year 2025 assumes approximately $65 million to $75 million of combined net sales of Trichetti XR and our Stellar XR.

Tim Dec: For the full year 2025, we expect combined R&D and SG&A expenses to range from $435 million to $460 million.

Tim Dec: Overall, we expect full year 2025 operating earnings in the range of $10 million to an operating loss of $15 million.

Tim Dec: And finally, we expect non-GAAP operating range to range from 100 to 5 million to 130 million.

Tim Dec: Please refer to the Art Expression Release issued prior to this call that identifies the various ranges of reconciling items between GAP and non-GAP.

Tim Dec: With that, I will now turn the callbacks over to the operator for Q&A.

Thank you.

Tim Dec: 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.

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Speaker Change: Our first question comes from Andrew Tassai at Jeffries. Your line is open.

Andrew Tassai: Hey, thanks for taking my questions. Good afternoon. Congrats on the nice quarter. A couple of questions to start.

Andrew Tassai: If we backed out other products from your 2025 Revenue Guidance with reasonable assumptions,

Andrew Tassai: We try not to give guidance by product, but you could back into something like this.

Andrew Tassai: As far as the key levels for this year, there's certainly continued prescription growth.

Speaker Change: 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.

Speaker Change: and, you know, 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.

Speaker Change: The market grew by 9%, we grew by 25% last year, and we still have a long way to go here. As I mentioned, the market is now at 103 million prescriptions a year. We're only at 767,000 prescriptions in 2024.

Speaker Change: We still have a lot of penetration that we can accomplish clearly with the product.

Speaker Change: And the basics of the product are still very, very solid. What I'm referring to is really satisfaction by patients.

Speaker Change: The very important segment, for example, the adult segment, the patient satisfaction is very high. It's around 80%.

to give you a little bit of reference.

It's only 53% horse fat there.

Speaker Change: And to have, you know, a very nice high satisfaction rate for a non-stimulant in the adult population, that that's really

Speaker Change: pretty strong. We all know adults love their stimulants, so for a non-stimulant to have that level of satisfaction, yeah. So we're very encouraged by a lot of the metrics behind the product and therefore looking forward to another hopefully strong here on Calvery.

Speaker Change: 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.

Speaker Change: 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.

Speaker Change: But aside from that, our BD activities will continue to be top priority at the company. Looking for, from a priority perspective, first commercial products. If we can bring in more revenue generating products.

Speaker Change: And then next priority would be things that are more in the mid-stage to late-stage pipeline assets.

Speaker Change: symptom processes and looking at assets outside CNS, as long as the situation involves

Speaker Change: As far as the size per se, it really depends on the situation itself.

Speaker Change: So that in total could range from 500 to a billion, billion and a half, I mean, depending on the situation and the cash generation by, you know, the target that we're looking at. Thanks so much. Appreciate it.

Speaker Change: Our next question comes from Stacy Kuh at TD Cohen. Your line is open.

Stacy Kuh: Thanks so much for taking our questions and congratulations on the progress. The first question is on Calvary.

Stacy Kuh: Set 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?

Stacy Kuh: And then a second question is on SPN 820. Are you able to kind of give some idea of the timing of your strategic conclusions you plan to make a decision this year? And then for the third question,

Stacy Kuh: for the Anapago 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.

Stacy Kuh: Yeah, I'll try to take them in the same order. So, on Calibri...

Stacy Kuh: as related to the pricing portion of that question. It really didn't change much. So the gross net on Calgary has been fairly stable now in the last three quarters.

Stacy Kuh: on the lower side of the range. Now, will it change in 2025? Absolutely. I mean, clearly Q1 is always, as we always know in this business in general, Kelby or no Kelby across all the industry.

Stacy Kuh: Q1 will be worse from a gross-to-net perspective because of the increase in the co-pay costs.

Stacy Kuh: as we improve the benefits to health patients, you know, through the deductibles and so forth. So, for the full year of 2025,

Stacy Kuh: Probably the gross net is going to be more in the 50 to 55 percent. 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 gross net.

Stacy Kuh: Regarding the second question you have on the adult launch, I mean, we're pretty pleased, as I told earlier, as far as performance of the product with adults, our efforts in the adult segment.

across male and female patient populations.

Stacy Kuh: and the product continues to perform really well. We do see more combination type of use and the adult patient population, meaning physicians, are adding Calbree to the existing stimulant that adults are on. And over time, they tend to reduce the stimulant dose.

Stacy Kuh: and increase the calorie dose, with the ultimate goal, of course, is to take the patients off the stimulant completely.

Stacy Kuh: But they try not to do that abruptly from day one.

Stacy Kuh: So they add Pelvri 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.

Stacy Kuh: Not as much in the pediatric side. On the pediatric side, we think that's more in the...

Stacy Kuh: 15 to 20 percent 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...

Stacy Kuh: People really don't have to be on controlled substances. I mean, if you have a non-sterolem that really works, whether you're an adult or a child.

We'll see you then.

The product really works within a week or two.

Stacy Kuh: 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 percent. So we're very optimistic about the potential in adults, especially given the importance of that segment in the marketplace.

Speaker Change: If I could just quickly follow-up, what share are you at for the adult segment right now in ADHD for Calbary with the split?

Speaker Change: I apologize, the flip, which is of the Calgary launches, of the Calgary prescriptions, what percentage is adult right now?

Speaker Change: Yeah, it bounces in the 30 to 32 percent. 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 percent pediatric and 67 percent adult.

Speaker Change: So we still have a lot of room where we can, you know, grow in the adult sector.

Speaker Change: 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 where could we do it earlier we'll see but certainly it wouldn't be this year you know as it related to your question

Speaker Change: We do think, potentially, we know what could be behind the results. We have looked at

You know cross

studies. We looked at different sub-analyses, patient populations, different things.

Speaker Change: We couldn't see anything really that sticks out that, you know, have resulted, you know, with the result that we issued, but...

Speaker Change: So we will be digging deeper into that aspect of it and see from a biologic perspective.

Speaker Change: 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.

Speaker Change: And actually, intermittent dosing is needed or required for the system to function very well and to regulate, you know, depressive symptoms.

Speaker Change: And therefore, intermittent dosing is probably more suitable than frequent, every single day type of dosing, which was the case in the Chase 2B study.

Speaker Change: 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.

Speaker Change: And then I believe the last question was regarding on NETCO, Isabel, if I answered, you know, was it right?

Yep, that's correct.

yes

Speaker Change: Could you go ahead and repeat the question if you don't mind? Yeah, 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 the guidance. Oh, okay. Yeah, sure.

Speaker Change: Yeah, the trajectory of the launch, I mean, we 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 cables have been waiting for this product. And we may, we may have a bolus of patients who may come in at the beginning.

Speaker Change: and then it will start going back to a more normal, slower rate. So all that remains to be seen. There 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 Onetco. It's really a single-digit number.

Speaker Change: The result is a high single digit so it's not much as far as this year's guidance.

Thank you so much.

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Our next question comes from Annabelle Simame, ex-FIFO.

Thank you for watching!

Speaker Change: Hi, this is Jack on for Annabelle. Thanks for taking our questions.

Speaker Change: 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?

Speaker Change: As you would probably expect, I mean, the definition of advanced...

Speaker Change: 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 who's been diagnosed now 10 years ago. They've tried a lot of agents out there, a lot of the oral adjunctus therapy with libidopacarbidopa, and they're getting to a point where...

Speaker Change: I've had a patient who's only been diagnosed three or four years ago, but...

Speaker Change: 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.

Speaker Change: Everything we do, promotional and everything, will be centered around advanced patients.

Speaker Change: And as far as the interaction or the overlap, if you want to say, between ONAPCO and potentially APRICOTAN.

Speaker Change: Just to clarify, Onetco is really providing you with all-day continuous infusion of apomorphine, and it is for all-day control.

Speaker Change: 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.

Speaker Change: Now, we have said in the past that potentially there might be some overlap or some cannibalization of apricotin in case you have patients, for example, who might be taking multiple injections of apricotin during a certain day.

Speaker Change: They may choose to try the pump. I mean, there is a possibility, but clearly, from our perspective, the two products are separate.

Speaker Change: Abogan indication is for acute treatment, single injection. Obviously, the pump is more for an all day control with a continuous infusion of apomorphine. And generally speaking, apomorphine.

Speaker Change: is really a great drug, and it really differentiates significantly from, first of all, the oral dopamine agonist.

Speaker Change: It is very much like dopamine, it acts like dopamine, it actually has one of the best

for joining us today.

Speaker Change: Just like the D1 through D5 receptors, unlike some of the oral dopamine agonists, they don't have affinity to the D1 family.

Speaker Change: to convert apomorphine to dopamine so that it can get to the post-synaptic neurons.

Speaker Change: 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.

Thank you for watching!

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Great, thank you.

Thank you.

Our next question comes from David Amsalom at Piper Sandler.

David Amsalom: Thanks, just a couple for me. So first on ADHD and Calgary 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 psoriatic and adult patients.

David Amsalom: 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 donats going forward? So that's number one.

David Amsalom: 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.

David Amsalom: We really don't have and haven't seen any, you know, Phase 3 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.

David Amsalom: 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.

David Amsalom: 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.

David Amsalom: 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 payoff strategy across Ford. And we're very pleased, you know, with the coverage that the product has today and in the foreseeable future.

David Amsalom: Finally, on the price of Oneto, 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 Kenter Fitzgerald.

Kristen Kluska: Hi 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 and 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

David Amsalom: believing in this and talking about the data and have had anecdotes from physicians in the past.

David Amsalom: Yes, ADHD is very well known and to have significant comorbidities across board. A lot of it are mood disorders such as depression, anxiety, even bipolar and so forth.

David Amsalom: As far as the percentages, they do range, you know, from, we've seen numbers from the, as many as 40 to even 60% of ADHD patients that have a lot of these comorbidities.

David Amsalom: 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.

David Amsalom: We have certainly, as I mentioned in my prepared remarks, we were certainly pleased with the fact that

David Amsalom: It is now acknowledged that Veloxazine is very different than 8-Omoxazine.

David Amsalom: It does have a very unique mechanism of action. It is a multi-modal pharmacodynamic activity that happens with Veloxacin, specifically on the serotonin.

David Amsalom: And that's really what has separated the molecule for actually years or decades.

David Amsalom: 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.

David Amsalom: But it was a very important scientific information that physicians have been looking for since, you know, actually the day we've been developing the category because they have seen certain things in the clinical studies.

David Amsalom: 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.

David Amsalom: 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, you know, physicians on the activity of the drug in general.

David Amsalom: And clearly, we are very also encouraged by the open-label study that I talked about, which is in ADHD and comorbid disorders, mood disorders.

David Amsalom: So we encourage folks to look at the publication of the poster at the conference in May.

Speaker Change: We look for areas that don't necessarily have to be 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...

Speaker Change: 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.

of products or product candidates, pipeline assets.

Speaker Change: 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 is...

Speaker Change: How we think about it, and it doesn't really matter whether 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 sex force effort behind it.

Speaker Change: In addition to that, we have a really good infrastructure to deal with the rare disease and orphan diseases. We're very well set up, especially, for example, in the Parkinson area, you know, where we have a very strong infrastructure to support rare or orphan diseases. So those would be also areas that we would be interested in.

Thanks, everyone. Have a great day.

Thank you, Jack.

Thank you.

Thank you. Bye-bye.

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

Jack Khattar: 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.

Jack Khattar: The company has executed well through a multi-year transition and the loss of exclusivity on two of its legacy products.

Jack Khattar: Excluding our legacy products, we continue to deliver robust double-digit growth in revenues.

Jack Khattar: The company continued to generate also strong cash flows behind the strength of its portfolio, particularly its core products, and to the efficiency of its operations.

Jack Khattar: 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.

Jack Khattar: We believe we are well positioned for continued growth beyond the current transition and our focus on several key areas. First,

Jack Khattar: driving growth and generating strong cash flow from our core products, particularly Kelby, allowing us to continue our investments in our pipeline.

Jack Khattar: Second, the launch of Ornacto in the second quarter of this year. And third, advancing our innovative R&D portfolio of differentiated first and last models.

Jack Khattar: Finally, corporate development will continue to be a top priority to augment our growth through external opportunities. Thanks again for joining us this afternoon, we look forward to updating you on our next call.

Jack Khattar: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Q4 2024 Supernus Pharmaceuticals Inc Earnings Call

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