Supernus Pharmaceuticals, Inc.

Good afternoon, and welcome to the Separate Niche Pharmaceutical Third Quarter to 724 Financial Results Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. Instructions will follow at that time. As a reminder, this conference call is being recorded. I would now like to turn the conference over to Peter Basel of ICR Healthcare Investor Relations, representative of Separate Niche Pharmaceuticals. You may begin.

Thank you, Marvin. Good afternoon, everyone, and thank you for joining us today for Sopernos Pharmaceuticals' third quarter 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 Katar, and Chief Financial Officer, Tim Deck. Today's call is being made available via the investor relations section of the company's website at ir.sopernos.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 Kernes' 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 violence. Actual results may differ materially from those projected in these forward-looking statements. For the benefit of those of you who may be listening to the replay, this call is being held and recorded on November 4th, 2024. Since then, the company may have made additional announcements related to the topics discussed. Please reference the company's most recent press releases and current filings at the SEC. The apprentice declines any obligation to update these forms of the statement except as required by applicable securities laws. Now is the call of your director.

Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us on today's call. The third quarter of 2024 was characterized by strong performance from the company's key growth drivers, Calgary and GoCovery, significant operating earnings growth, and advancement of our product pipeline. Total revenues, excluding for Kendi XR and AccelerXR, increased 26% in the third quarter. Driving this growth was Calgary's robust performance with 19% growth in prescriptions as reported by IQVIA and 68% growth in net sales. Prescriptions reached another all-time quarterly high of 194,000, and net sales were 62 million, representing an approximate annualized run rate of $250 million. Gross to net deductions during the third quarter of this year were slightly below our revised target range of 45 to 50%, but with an expectation based on fluctuations that you would typically expect on a quarterly basis. During the third quarter, Calgary further expanded its base of prescribers by more than 2,000 prescribers, ending the quarter with approximately 30,854, up from 28,326 in the second quarter of 2024. For the back-to-school season, Calgary performed well with a prescription growth in September of 14% over June. Finally, for the first nine months of this year, Calvary's IQ prescriptions grew by 25% compared to the same period last year, outpacing the ADHD market's growth of 9% for the same period. Regarding recovery, recovery from the first quarter continued with net sales increasing to $36 million in the third quarter of 2024, representing an 8% growth over the same period in 2023. Switching now to our legacy products, Oxtel XR net sales for third quarter 2024 were $30 million, essentially flat compared to the third quarter of last year. And for Trekendi XR, third quarter net sales were $15 million, down 26% from the same quarter of last year. For the first nine months of 2024, net sales of Trekendi XR were down 35%. We expect further erosion in Trocandy XR sales for the remainder of 2024 and into 2025. The first generic for AccelerXR entered the market in early September of this year, resulting in a sequential decline in monthly prescriptions of 26% compared to August 2024. We expect further erosion in the branch prescriptions in the fourth quarter. Given the trends in the first nine months of 2024 and our expectations for Oxtelrexor for the remainder of 2024, we are raising the target combined net sales of Trukendi XOR and Oxtelrexor in 2024 to be approximately $155 million. Regarding SBN 830, in August 2024, the FDA acknowledged the resubmission of our new drug application with a PDUFA date of February 1, 2025. We remain committed to Parkinson's patients who need this new treatment option, and assuming timely FDA approval, look forward to launching the product in the first half of 2025. Moving on to our CNS pipeline of novel product candidates, we announced exciting data recently, and we have several catalysts coming up in the near to midterm period. On SBN 820 in October, we provided data from our exploratory open label phase 2A study in adults with major depressive disorder. In the study, SBN 820 demonstrated a rapid decrease in depression symptoms beginning within hours of the first dose, as well as a substantial effect on depression symptoms observed in two depression scales, MADRAS and MD6. In addition, the data showed a substantial reduction of 80% in suicidal ideation and a well-tolerated safety profile with few adverse events The company expects to provide data from its Phase 2B double-blind placebo-controlled adjunctive study of SPN820 in adults with treatment-resistant depression in the first half of 2025. Enrollment of approximately 236 subjects is expected to complete in November of this year. Moving on to SPN817, the company has been conducting an open-label Phase 2A study in patients with treatment-resistant seizures. In May 2024, the company announced data from a planned interim analysis from the initial stage of the study, or Stage A. The company has now completed enrollment for Stage A and is reporting top-line data from all subjects with focal seizures who received the three milligram and four milligram twice daily doses, who completed the maintenance period and enrolled in the post-maintenance extension period. In the maintenance period, SBN 817 showed a 56% median seizure reduction from baseline, with 70% of subjects having 30% or more seizure reduction, and 60% of subjects having 50% or more seizure reduction, and 30% of subjects having 75% or more seizure reduction. In the post-maintenance extension period, SPN817 showed a 66% median seizure reduction from baseline, with 83% of subjects having 30% or more seizure reduction, 67% of subjects having 50% or more seizure reduction, and 50% of subjects having 75% or more seizure reduction. Regarding seizure freedom, we saw in the maintenance period, one subject out of 10 or 10% who completed a post-baseline seizure diary had at least one four-week seizure-free period. Similarly, in the post-maintenance extension period, one out of six subjects, or 17%, had at least one four-week seizure-free period. Assessment by EpiTrac, a validated cognitive screening tool designed for patients with epilepsy, indicated that 75 percent of 16 subjects was equally split between those who improved and those who had no change in cognitive function. SPN817 was safe and had acceptable tolerability with two subjects out of the 26 subjects who entered the maintenance period discontinuing because of treatment-related adverse events. Stage B of the Phase IIa study is ongoing and includes the concomitant use of an antiemetic to reduce cholinergic adverse events observed in the study. The Phase IIb randomized double-blind placebo-controlled study in patients with treatment-resistant focal seizures is expected to start by the end of 2024, studying the 3 milligram and 4 milligram doses. Also, the company initiated dosing in a phase one single-dose study of SPM443 in healthy adults. SPM443 is our new product candidate for CNS disorders. Finally, we remain active in corporate development, looking for strategic opportunities to further strengthen our future growth leadership position in CNS. With that, I would now turn the call over to Tim.

Thank you, Jack. Good afternoon, everyone. As I review our third quarter 2024 results, please refer to today's press release and 10Q that were filed earlier today. Total revenue for the third quarter of 2024 was $175.7 million compared to $153.9 million in the same quarter last year. Total revenue in the third quarter of 2024 was comprised of net product sales of $170.3 million and royalty and other revenue of $5.4 million. The increase in net product sales was primarily due to the increase in net product sales of our growth products, Calgary and GoCover. Excluding net product sales of Trekendi XR and Xtellar XR, total revenues for the third quarter of 2024 increased 26% compared to the same quarter last year. For the third quarter of 2024, combined R&D and SG&A expenses were 98.8 million as compared to 105.4 million for the same quarter last year. The slight decrease was primarily due to an insurance recovery for certain legal costs, all set by increased R&D expense associated with the clinical programs for SBN 817 and SBN 820 as we continue to progress our pipeline. Operating earnings on a gap basis for the third quarter of 2024 were $40.9 million as compared to $8.1 million for the same quarter last year. This is a $32.8 million increase in operating earnings compared to the same quarter last year, driven primarily by an increase in net product sales, but also by a decrease in cost of goods sold and the aforementioned decrease in SG&A. gap net earnings were 38.5 million for the third quarter of 2024 or 69 cents per diluted share compared to gap net loss of 16 million or 29 cent loss per diluted share in the same quarter last year on a non-gap basis which excludes amortization intangibles share based compensation contingent consideration and depreciation Adjusted operating earnings for the third quarter of 2024 were $67.7 million compared to $37.3 million in the same quarter of last year. This represents a $30.4 million increase. Total revenue for the nine months ended September 30th, 2024 were $487.7 million compared to $443.2 million in the same period last year. Total revenues were comprised of net product sales of $471.3 million and royalties, licensing, and other revenues of $16.4 million. The 13% increase in net product sales was primarily due to the increase in net product sales of our growth products, Calgary and GoCoverty. Excluding net product sales with Trekendi XR and Xtellar XR, total revenues for the nine months ended September 30, 2024 increased 23% compared to the same period last year. Combined R&D and SDA expenses for the nine months ended September 30, 2024, were $322.3 million, as compared to $323.3 million for the same period last year. Operating earnings on a GAAP basis for the nine months ended September 30, 2024, were $60.3 million, as compared to an operating loss of $4.3 million for the same period last year. This is a $64.6 million increase in operating earnings compared to the same period last year. GAAP net earnings were $58.5 million for the nine months ending September 30, 2024, or $1.05 per diluted share, compared to $141,000, or 0 cents per diluted share, in the same period last year. On a non-GAAP basis, which excludes amortization intangibles, share-based compensation, contingent consideration, and depreciation, adjusted operating earnings were $135.4 million compared to $77.9 million in the same period last year. This is an approximately 74% increase year over year. As of September 30, 2024, the company had approximately $403.2 million in cash, cash equivalents and current and long-term marketable securities compared to $271.5 million as of December 30, 2023. This increase was primarily due to cash generated from operations. Based on 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 the full year 2024, the company is raising its financial guidance. As a result, we expect total revenues to range from 630 million to 650 million, up from the previous range of 600 million to 625 million, comprised of net product sales, royalties, licensing, and other revenue. For the full year 2024, we expect combined R&D and SG&A expenses to range from $430 million to $450 million, from the previous range of $430 million to $460 million. Overall, we expect full-year 2024 GAAP operating earnings to range from $50 million to $65 million, and non-GAAP operating earnings to range from $150 million to $170 million. Please refer to the earnings press release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non-GAAP. With that, I will now turn the call back over to the operator for Q&A.

Thank you. At this time, we'll conduct a question and answer session. 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 the line of Andrew Tsai of Jack Reef.

Your line is now open.

Good afternoon. Thanks for taking my questions. Congratulations on the quarter, and thanks for the updates. First, with this new data set, are we interpreting this correctly in that the overall seizure reduction for patients at three to four meg doses through the maintenance period is now 56% on 10 total patients with which would compare to 35 percent last time. So is the next batch of four patients performing in a way that decreased the overall seizure reduction from 75 to 58 percent, or 56 percent, sorry.

And sorry, you were cutting off a little bit, but I think I got the gist of the question. on 817, as far as the seizure reduction, we continue to see, you know, very healthy levels of seizure reduction, very robust actually. And if you know from the data we just announced today, you'll see that in the maintenance period where we had 10 subjects, and these are the 10 subjects that were on the 3 milligram and 4 milligram twice daily. 56% reduction. And then six of those ended up in the post-maintenance extension period. So they stayed through the maintenance period and then kept in the state in the study through the extension period. And serial reduction in that period went up to 66%. Similarly, with the responder rates, you'll notice between the maintenance period and the post-maintenance period, you'll notice that the rates are going up. So it's interestingly, again, this is an exploratory study as we explained earlier. The numbers are fairly small in general, but it's interesting to see that as subjects or what seems like happening here is that as subjects stayed longer on the drug, stayed in the study for longer, And this is the first time we have enough number of weeks, so to speak, as far as reading data. Because when we reported the interim analysis way back, we had only very few, you know, patients on few weeks treatment, not for a long period of time. It's really nice to see that 83% of the subjects had 30% or more seizure reduction. And even at 75% or more seizure reduction, not very nice to see that 50% of patients had that level of seizure reduction. So, in general, I mean, we think this really study at the end of the day achieved the objective of leading us to believe that this can be a very strong, you know, product in the seizure area. We are improving and working on improving the tolerability as we discussed way back in May. The study achieved its objective in helping us decide what is the dose that we need to study further in the Phase 2b, and that's why we picked the 3 and 4 milligram because they seem to be the two appropriate doses based on the data we have, you know, we have so far. And that's what we're studying in the Phase 2b. So all in all, we still feel pretty good about the drug. Absolutely, this is an open label. Of course, it's exploratory. Again, smaller numbers. And as we segment the data more and more and cut it down, we end up with like two patients here and three patients there. It becomes even less meaningful. So that's why we're trying to stay focused on the main patient population that we're moving forward with, which is focal seizures, and the doses that we're gonna move forward, which is three to four milligram. Hopefully I answered most of your question.

Yes, thank you, thank you. And as for the apomorphine pump under review, notice AVI's pump was recently approved and they spoke highly of its own thinking about read across to your own review. How might AVI's fast,

approval serve as a positive for you if at all just curious um yeah i mean regarding the pump we're pretty actually excited overall for patients in general for the category to see and hopefully our pump will be approved in february to see these pumps eventually get to the marketplace uh there's a lot of market education that has to occur and you know we welcome another company to be doing that with us and educating patients on this specific treatment segment that we will be creating together in the market in the U.S. Outside the U.S., you know, that market segment has been around for a long time, and people have been using the pumps, you know, fairly well and are used to using them. So we welcome that opportunity. We think this is a great category. This is a very much needed treatment option for patients before they resort. to invasive, you know, surgery or treatments. And we think, you know, the pumps could be fairly differentiated. We'll see what our label look like and how they do compare. But there will be enough room for both products, no question about it. There is a lot of patients out there that are not really doing that well, and they could do really better with products like this.

Great. And the last question, thank you, is SPN820 for, where you saw the 22-point or so madras reduction by day 10 in your recent MDD study. Do you expect that level of drug effect to be replicated in your TRD study with data in first half? And I'm just curious what you're assuming for drug and placebo at week five in that TRD study. Thank you.

Yeah, I mean, that's, of course, the big question, Andrew, obviously. you know, the study we reported on is open label. The study we'll hopefully report on, you know, in the first half of next year is a placebo control. Now, simplistically, and I know you're not supposed to do that because these studies are open label and what have you, but if you look at all depression or a lot of the depression trials out there, you look at the, on an average, what the placebo rates are on MADRAS. I think I saw one report by someone did research in the space looking at around 23 different studies. Placebo rates are in the 5 to 10, you know, point reduction on madras. And if I apply that to our open label, you know, I still get very, very meaningful reduction in madras with our open label data. So it's hard to predict clearly. Obviously, I would rather have an open label study with this kind of data versus much lower reductions. The other encouraging thing is, you know, the new data we just actually had a post on the site Congress, the most recent site Congress, where we looked at remission data and responder type of data. I mean, within four hours, you're looking at a remission of about 35%. I mean, that's really powerful. Or 50% response to mad risk. Again, within four hours of the dose. And that goes up by day 10 to 63% on the remission and 84% with the response rate. I mean, these are really fairly strong numbers. Again, we sure hope that a lot of these will continue to be the case with the phase 2b. I mean, that's obviously the goal.

Right. Okay. Thank you so much. Sure. Thank you. We'll move it for our next question.

Our next question comes from the line of Stacey Koo of TD Cal, and your line is now open.

Hey there. Congrats on a nice quarter. We have a few questions. So first, just on kind of the key Calgary launch, how are you thinking about the current volumes that you're seeing and whether you're on the right trajectory for a 25 Calgary consensus. I think expectations are closer to 282 million, at least on SACSAT. What are your views there? And then as we think about kind of the net pricing we saw this quarter, how should we be thinking about the remainder of the year and how that might look as we go to 25 as we tie in that question around consensus? So just curious your views as we look next year. As much as you can comment, just give us some understanding about kind of the growth dynamics into next year. That's the first kind of set of two questions. And then a quick follow-up. For 820, the dosing strategy in the MDD trial was a touch different than TRD. Are you expecting the placebo response to be a touch more well-controlled since you're not having the patients come in as frequently? There seems to be kind of a a need for the patients in the open-label trial to come in very frequently. So just help us understand that dynamic as we think about placebo response and what could be expectations for the TRD study. Thanks so much.

Yeah, regarding the first question on utility as far as volume, I mean, we've been very pleased with the way the product is growing, has been growing, and the kind of growth it's shown in 2024. Year-to-date, about 25% on prescriptions. There are a couple dynamics that we've been seeing in the market and on the brand. One of them is we continue to see growth in the 90-day prescriptions. That is something which, obviously, when you read IQVIA data or IMS data, you may not see it. unless you really dig into it deeper. And we're closing in somewhere around the 11% of the prescriptions for the brand are now 90-day prescriptions. And that has grown from about what used to be 7% of the prescriptions. So if that continues, that really tells us also that every prescription is much bigger than your usual 30-day prescription. So on a capsule or pill basis, the brand is growing much faster than what you see in the TRXs, clearly. So that also tells us that people, you know, are sticking to the brand. Otherwise, the physician will not give you a 90-day prescription if they don't think, you know, you're doing well on the product, clearly. It helps with compliance and retention. we do see also strong rates of retention and what's really very healthy levels in general on Calgary compared to the ADHD market overall. So we're very optimistic as to where the brand is today and how healthy and robust the performance has been so far. And we sure hope that that will continue in 2025. And clearly in February next year, we'll talk a little bit more specifics as far as you know, the sales or anything specific as far as growth rates and so forth. Regarding the net pricing, we continue to see very healthy net pricing as evident with this quarter as the gross to net improvements continue over time. And the answer is yes, we will expect that similar type of net pricing, you know, for the rest of the year in 2024. Again, for 2025, we'll reserve any comment on that until we have the fourth quarter behind us. Then we can better discuss what 2025 might look like. But overall, we're very pleased with Calbee, the health of the product, its strong performance, compliance, retention. I mean, everything is pointing to the fact that the brand, the product really works. It really works, and people stick to it. They are compliant. And the physicians are happy with it once they tried with a lot of these patients. And I'm talking about both, pediatric and adult, you know, for both patient populations. As far as the second question, which is more on the placebo response, and, I mean, that's really a very hard question to, you know, speculate on at this point, Tracy. I mean, MDD versus TRD and whether the flexible dose versus the daily dose. Yes, I mean, the MDD trial had one single dose given every three days versus the TRD was and is a daily dose, but a lower dose level, 800 to 1600 milligrams versus a single dose of 2400 milligrams. It's really hard to predict. and to see and speculate as to what the phase 2b placebo response will end up being. So on that one, I think we'll just have to wait and see what the data will end up showing at the end of the time. Okay.

Understood. Thank you. Thank you. Hold on a minute for our next question.

Our next question comes from the line of .

Your line is now open.

Thanks. So I have a couple. First, can you give us your latest thoughts on capital deployment and how you're thinking about M&A specifically, whether you're prioritizing commercial stage assets versus pipeline-focused assets and just how you're thinking about that, particularly in the context of the advancement of your internal pipeline. So that's number one. Then secondly, regarding CalBRI, I wanted to pick your brain about how you're thinking about the competitive landscape longer term. We're going to get data for Axome, Sol-Re-Amputol, I believe in adult patients in the near future. So as you're thinking about other non-stimulant entrants like that product, how are you thinking about the potential impact to Calgary longer term, if at all? Thank you.

Regarding the first question on capital deployment and M&A, our priorities haven't really changed much. We continue to focus. Our priority would be commercial products that bring us further revenue, growth, cash flow, and so forth. And the next priority would be pipeline assets that are at a later stage than our own pipeline. So clearly the pump hopefully will launch the pump, but beyond the pump, our two other assets are in phase two or about to finish phase 2B. So anything in phase three or anything in NDA stage or whatever will be something focused for us so we can bring in other products and launch other products other than on pipeline. So that's the focus of our activities and has been the case for a long time right now. And we continue to focus on CNS as our top priority. But I mentioned several times before that we're not shy about looking at other specific therapeutic areas where we can make an impact and we can market our products efficiently and effectively, other specialty areas. But those situations will have to be a little bit more multi-asset type of situations, not just one product, but potentially a product with a pipeline or a couple products that are commercial and that where we can build a very strong presence in that new area whatever that new area might be in cns with agnostic whether it's neurology or psychology so we continue to look at both areas given our presence fairly you know in both of these areas from a salesforce commercial infrastructure perspective um as far as competition to kelby i mean at some point there will be a competition no question about it um you know, you really have to see at the end of the day the profile of these two products, you know, for us to really make a comment one way or the other, how would they compare to Calvary or what kind of patient profile would be ideal for these new products. So clearly we're watching the situation and see, you know, as data comes out of the potential competitors, see how they fare, you know, against Calvary or compared to Calvary in general. So that remains to be seen. And then also, what are their stimulants or non-stimulants? I mean, that's another key factor, clearly.

That's helpful. If I may just sneak in a quick follow-up just regarding M&A. Is there a pro forma net leverage target beyond which you would not be comfortable going in the context of a transaction, particularly for a commercial stage asset?

We try to stay fundamental. Now we run the business and also conservative as far as leverage, so we don't want to over-leverage. We are comfortable in the 2.5 to 3 times EBITDA maybe. I mean, that's as far as we would go. And at the end of the day, it all depends, as we all know. It really depends on the health of the assets that you're acquiring and how quickly you may be able to pay off the debt and therefore you might make different decisions on leverage, you know, depending on that situation. So if these assets are, you know, fairly strong cash flows with longevity, clearly, and high growth rates, you know, you might be able to feel a little bit more comfortable and leverage a little bit higher. But overall, I mean, give or take two and a half to three times will be the area where, you know, we'd be comfortable with. Above that, it gets a little bit, And especially if there is no longevity or not ideal longevity, I should say, or ideal growth rates for these assets.

Thank you. Thank you. One moment for our next question.

Again, as a reminder to ask a question, you'll need to press star 1-1 on your telephone.

I am showing no further questions at this time.

I'll now turn it back to Jack Attar for closing remarks.

Thank you. In concluding our call this afternoon, we thank you for joining us to learn about our strong performance in the third quarter and first nine months of this year. The company has executed remarkably well through a multi-year transition and the loss of exclusivity on two of its legacy products. Excluding our legacy products, Trekendi XR and Xtellar XR, we continue to deliver robust double-digit growth in revenues. As a result, Trekendi XR represented only 9% of total revenues in the third quarter of 2024. Moreover, the company continued to generate strong cash flows behind the strength of its portfolio, particularly its growth products and through the efficiency of its operations. In addition, we continue to advance our product pipeline and now see positive pipeline data from our open-label Phase II studies on SPN817 and SPN820, and we look forward to the upcoming catalysts over the next several months. 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.