SUPN - NASDAQ

Good afternoon, and welcome to the Supernus Pharmaceuticals First Quarter 2024 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to Peter Vozzo of ICR Westwicke, Investor Relations representative for Supernus Pharmaceuticals. You may now begin.

Thank you, Mark. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' First 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 Supernus' Chief Executive Officer, Jack Khattar; and Chief Financial Officer, Tim Dec. Today's call is being made available via the Investor Relations section of the company's website at ir.supernus.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 Supernus' current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the Risk Factors section of the company's latest SEC filings. Actual results may differ materially from those projected in these forward-looking statements. For the benefit of those who may be listening to the replay, this call is being held and recorded on May 8, 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 with the SEC. Supernus declines any obligation to update these forward-looking statements, except as required by applicable securities laws. I will now turn the call over to Jack.

Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us on today's call. Following a productive year in 2023 in which we successfully minimized the impact of the Trokendi XR loss of exclusivity and position the company to mitigate the potential impact from the first generic on Oxtellar XR, we have continued to execute on our long-term growth strategy and have delivered another quarter with double-digit growth in total revenues, excluding Trokendi XR and Oxtellar XR. Driving this growth is Qelbree's strong performance with 31% growth in prescriptions as reported by IQVIA and 75% growth in net sales. Prescriptions reached an all-time quarterly high of 176,503 and net sales were at $45 million. Growth in net sales in the first quarter of 2024 benefited from both prescription growth and gross to net improvement compared to the same period last year. Gross to net during the first quarter of this year was well within our target range of 50% to 55%, which is encouraging for the first quarter considering the typical beginning of year pressure from high deductibles and insurance resets that are seen across the pharmaceutical industry. For the remainder of 2024, we expect the gross to net for Qelbree to remain in the range of 50% to 55%, with fluctuations that you would typically expect on a quarterly basis. During the first quarter, Qelbree further expanded its base of prescribers ending the quarter with approximately 27,138, up from 25,938 in the fourth quarter of 2023. Prescriptions from adult patients now account for approximately 32% of Qelbree's total prescriptions. Switching now to our Parkinson's franchise. We saw increased pressure on our brands in the first quarter with higher Medicare rebates based on out-of-pocket costs and the closing of the patient-assisted funds to new and existing patients. These dynamics contributed to increased gross to net deductions for our brands leading, for example, to lower growth of 2% on net sales of GOCOVRI compared to the same period in 2023. During the quarter, we also saw a significant 42% increase in sample distribution by physicians to patients. This increase in sample usage allowed many patients to stay on GOCOVRI while waiting to hit their maximum out-of-pocket costs. We have already seen a bounce back in the GOCOVRI business in the second quarter as we believe patients started transitioning from their samples to refilling their prescriptions. Switching to our legacy products. Oxtellar XR net sales for first quarter 2024 were $26.9 million compared to $28.9 million in the first quarter of last year. We expect the introduction of the first generic of Oxtellar XR in September 2024. For Trokendi XR, first quarter net sales were $16 million, down by 54% from the same quarter last year. With expected further erosion of Trokendi XR and the entry of an Oxtellar XR genetic label this year, we continue to anticipate combined net sales of Trokendi XR and Oxtellar XR in 2024 to be in the range of $125 million to $135 million. Regarding SPN-830. As we disclosed in April, the FDA issued a complete response letter in response to the company's NDA, indicating that the review cycle for the application is complete but that the application was not ready for approval in its present form. The company will announce the filing for its resubmission after meeting with the FDA later this month. We are committed to Parkinson's patients who need this potential new treatment option and to bringing SPN-830 to the marketplace. Moving on to our emerging CNS pipeline of novel product candidates. We have exciting catalysts coming up in the next 12 months. Regarding SPN-820, the company expects to provide data from its Phase IIb study in adults with treatment-resistant depression in the first half of 2025. The Phase IIb study recently achieved more than 50% enrollment of the total 268 targeted number of patients. The Phase II open-label study is currently enrolling and targeting a total of about 50 patients with major depressive disorder. Regarding the Phase IIa study of SPN-817 for treatment-resistant seizures. The company now expects to report interim data from approximately 40 patients, greater than the 1/2 of total randomized patients originally targeted. As such, we plan to hold the conference call on May 23 to report these interim data. This study is examining the safety, tolerability and efficacy of SPN-817 as adjunctive therapy in adult patients with treatment-resistant seizures. Top line results for the full study are expected in the second half of 2024. In addition, we plan to initiate a Phase I single-dose study of SPN-443 in healthy adults following submission of an investigational new drug application. SPN-443 is our new stimulant-like product candidate for ADHD and other CNS disorders. Finally, we remain active in corporate development, looking for strategic opportunities to further strengthen our future growth and leadership position in CNS. With that, I will now turn the call over to Tim.

Thank you, Jack. Good afternoon, everyone. As I review our first quarter 2024 results, please refer to today's press release and 10-Q that was filed earlier today. Total revenue for the first quarter of 2024 was $143.6 million compared to $153.8 million in the prior year quarter. Total revenue in the first quarter of 2024 was comprised of net product sales of $138.4 million and royalty and licensing revenues of $5.2 million. The $2.2 million decrease in net product sales was primarily due to a $20.8 million decline in net product sales of Trokendi XR and Oxtellar XR, partially offset by a $19.3 million increase in net product sales of Qelbree. Excluding net product sales of Trokendi XR and Oxtellar XR in both periods, total revenues for the first quarter of 2024 increased 12% compared to the prior year quarter. For the first quarter of 2024, combined R&D and SG&A expenses were $111.4 million as compared to $106.8 million for the prior year quarter. The increase was primarily due to R&D spend associated with the clinical programs for SPN-817 and SPN-820 as we continue to progress our pipeline. Operating loss on a GAAP basis for the first quarter of 2024 was $3.2 million as compared to an operating earnings of $5.2 million for the prior year period. Income tax expense in the first quarter of 2024 was $119,000 as compared to an income tax benefit of $7.9 million for the same period in 2023. GAAP net earnings was $124,000 for the first quarter of 2024 or earnings per diluted share of $0.00 compared to GAAP net earnings of $16.9 million or earnings per diluted share of $0.29 in the prior year quarter. On a non-GAAP basis, which excludes amortization of intangibles, share-based compensation, contingent consideration and depreciation, adjusted operating earnings for the first quarter of 2024 was $22.3 million compared to $30.5 million in the same quarter of the prior year. As of March 31, 2024, the company had approximately $309.4 million in cash, cash equivalents and marketable securities compared to $271.5 million as of December 31, 2023. The increase was primarily due to cash generated from operations. The company continues to have a strong balance sheet with significant financial flexibility for potential M&A or other value-creating opportunities. Now turning to guidance. For full year 2024, the company reiterates its financial guidance for total revenue, combined R&D and SG&A expenses and non-GAAP operating earnings. As such, we expect total revenues to range from $580 million to $620 million, comprised of net product sales, royalties and licensing revenues. For the full year 2024, we expect combined R&D and SG&A expenses to range from $430 million to $460 million, reflecting increased level of R&D spend as our pipeline progresses. Overall, we expect full year 2024 GAAP operating loss in the range of $30 million to breakeven and non-GAAP operating earnings to range from $80 million to $110 million. Please refer to the earnings press release issued prior to this call that identifies the various ranges in reconciling items between GAAP and non-GAAP. With that, I will now turn the call back to the operator for Q&A.

[Operator Instructions] Our first question comes from Andrew with Jefferies.

So congrats on the progress, too. First one is on Qelbree. We're one month into Q2. Would you expect an acceleration in TRx scripts this quarter? Or should the quarter-over-quarter growth be relatively similar to what we saw in Q1 and then Q3 is when we see the real acceleration? And I'm just curious where you -- have you guys been impacted by the Change Healthcare cybersecurity attack as well?

Andrew, if you look at the first quarter of 2024 sequentially versus the fourth quarter of last year, prescriptions grew by about 2%, if I'm not mistaken, 2%, 2.5%. We're already seeing in the second quarter, if you look sequential growth quarter-to-date, the second quarter versus the first quarter, sequential growth is about 11% or 10%. So to answer your question, yes, it looks like it is starting to pick up. The Q1 time of phenomena, which typically maybe it's down a lot of activity and then so forth and insurance issues and so forth. So we're looking at acceleration in the second quarter already. Certainly, with the back-to-school season, we expect that to be healthier. I mean, that remains to be seen clearly as to how strong the back-to-school season, third quarter versus second quarter or third quarter versus the year before. Regarding the second question, the answer is no. We were not impacted by the Change Healthcare issue. We had other providers that could step in and continue to provide service for our customers.

Okay. And then on SPN-817. With later this month, we'll have the interim data set. How much follow-up data should we be expecting on all 40 patients? And maybe talk to us what kind of seizure freedom rates existing epilepsy drugs show and whether you think SPN-817 can surpass or be higher than those rates?

Yes. I mean, the first question as far as how much more data follow-up. I mean, as we said in our press release, we're going to -- or my remarks, we did not report on somewhere around 40 patients. We still have a few patients still in the study. So in the second half of this year when we report the full study, we will have a handful of more patients to report on so we can finalize all the full data set to report on. Regarding the second question as far as seizure freedom rates, and there are so many different definitions that people use regarding seizure freedom. But I mean, typically, I'll give you one example on Oxtellar XR. If I remember some of the data we had at one point around the 11% seizure freedom, which was very solid for a product, for example, Oxtellar XR, there are so many agents out there with a whole host of ranges of seizure freedom. Clearly, anything above the 10% typically is a good number, especially for those who are refractory patients. And in this space, 33% to 40% of patients are refractory. So it depends on are you getting seizure freedom within one patient population. If you're taking a patient from those who are refractory and you're turning them to be seizure free, that is incredible, even if it's 5%. But if you're taking people who are from the beginning started getting treated with epilepsy drug and then you throw them seizure-free early on in their disease and they have not progressed as badly, that probably is not as impressive. So there's a lot of variety of how people measure them and in what patient population.

Got it. Got it. And then last quick question is bigger picture. In general, how much firepower do you guys think you have in terms of BD or M&A?

In a very simplistic way, I mean we could probably do transactions in the $500 million to $1 billion, it could get higher if we use equity. So it all depends on the situation itself as far as the acquisition candidate, what profile that company has, does that company come with assets that generate significant cash flows, then you're able to leverage against these cash flows and maybe it will allow you to go to a bigger sized transaction. And if it is transformative kind of transaction, that an equity could become part of the mix as well for paying for that acquisition. So I think $500 million to $1 billion to $2 billion is a fair range. I know it's a wide range, but it all depends on the situation we're dealing with.

And our next question comes from David with Piper Sandler.

So I just have a couple. First, on Qelbree. So you see what you're doing nicely in terms of getting the gross to net target in the low to mid-50s. I guess just given where it already is, in 1Q, given that it's seasonally tougher, is it possible that the gross to net could dip below 50% as the year progresses? Just wanted you to talk to that, if you can. Then secondly, on SPN-830. Can you elaborate on the issue in the CRL or maybe not issue, but what was raised in the CRL regarding the master file for the infusion device? And is there anything that you've learned since the CRL as you've interfaced with the manufacturer that you can share with us? So that's number two. And then lastly, on SPN-817. Can you just remind us of the path forward beyond this Phase IIa? I believe the Phase IIb is in the works. So talk to the design of that study.

Yes, sure. First question on Qelbree and the gross to net. The reason we said for the full year, we remain to target 50% to 55% is because quarter-to-quarter, you're absolutely right, typically, gross to net improves. And if in the first quarter, we had a little bit better or we are in a good place to start with, there is nothing but to improve from here. The only caveat to this, sometimes we see quarter-to-quarter fluctuations, some of which are unexpected or unknown like a high return or something that could come in. So that's the only thing we're trying to be guarded against here. Everything else being equal, let me put it this way. Yes, there is a potential that we may end the year on the shorter end or the lower end of that range, if that makes sense. As far as SPN-830, I mean when we announced CRL, we did mention there are a couple of areas, one around the quality and one around the master which we're learning more and more now as we're having discussions directly with the manufacturer around that, we think these are areas that can be addressed and we already secured a meeting with the FDA later this month. So we're really moving pretty fast, as fast as we can, to hopefully address all these issues and wanted to make sure also there are no new issues that pop up later on. So we're trying to make sure we have everything we need before resubmission. And that's why we would like to have that meeting first before we communicate any time line for the resubmission. And then the last question on SPN-817. Just as a reminder, the current study we're reporting on, which is the interim data is on an open-label exploratory study where we looked at several types of seizures, we looked at so many different doses, and it was meant to help us learn as time goes on, as the study continues to enroll, help us in designing the Phase IIb study, which typically would be our next step. So clearly, that is the next natural step after the Phase IIa open-label study, and we will share the details with you guys on May 23.

And if I may just sneak in a follow-up on SPN-830. There was also -- the other issue raise was on product quality and I believe you said that you submitted that data to the FDA. Is it possible to elaborate on what was meant by product's quality?

Yes. I mean I don't want to get into all the details. It's regarding the formulation itself. So it's not a device issue. So that's when we say product quality. It was more related to the product, the formulation, the apomorphine solution, so to speak. That's as far as we can share at this point. And yes, we have submitted some data at that time that the FDA didn't have the time to review or didn't review. So clearly, the meeting, the upcoming meeting will be very important for us to clarify, do they need anything else on top of that or whatever we submitted to be sufficient. So that's really the purpose of that meaning.

And our next question comes from Stacy with TD Cowen.

Congratulations on the quarter. So we do have a few follow-ups. Just one more on Qelbree. That strong net pricing that we're seeing in Q1, whats' driving that? Is it higher doses because more adult patients are being added? Is it the price increase? Is it still kind of that pulling back the co-pay assistance program? And then as we look forward, as we consider these kind of gross mix fluctuations, that you kind of alluded to, are you going to be making investments as we think about back-to-school season this year? Just quarter-to-quarter, are we just -- should we expect a more stable net price for the year? That's the first question. And then the second question is going to be on SPN-817. It sounds like enrollment went a bit faster than expectations. So can you just broadly talk about study demand among the patients? And then just to set expectations, what do you expect will be competitive seizure reductions to move forward understanding this is an open label and you're going to give this data in late May? But just curious of the decision to move into late May and help set expectations for the Street.

Yes. Regarding Qelbree, and we talked about that actually several quarters regarding what are the key drivers for Qelbree to continue to grow and to continue to really perform well and obviously continue to grow the net price at the end of the day. Clearly, higher daily doses, and we can get there through different avenues, highly daily doses that patients are taking on a daily basis, whether it's pediatric or adult, and that is typically a function of physicians getting more and more comfortable with the medication and titrating up to the real dose that they need to use actually for the product to be very well effective in treating symptoms. And that is in line with the Phase III data. And based on the Phase III data, we did continue to communicate to our physicians what are the target total daily dose that they should be working up to in both patient populations. So clearly, as time goes on, we are getting there, the speed by which we get there is always -- it's hard to predict, obviously, because you always have new prescribers that are completely new to the product. And these new prescribers will always take it low and slow, so to speak, from a titration perspective. It also depends on how they're using it, if they're using it in combination with stimulants. Sometimes they go much lower and much slower because they're adding it to the stimulants that the patient is already on. And as they try to take the stimulant off from the therapeutic regimen for that patient and adding Qelbree, they will reduce the stimulant and increase the Qelbree dose. So that's a function of that patient on a case-by-case basis. And then the final dynamic that will impact higher doses is clearly the adult population. As our mix of the business continues to grow in adults and becomes a bigger piece of our total franchise, on a blended basis, clearly, that's going to increase the total daily dose and gives us the benefit of a higher price prescription. So the net price in the first quarter of this year was about $255 million, I guess, if you divide the net sales by the quarterly prescriptions which is down versus $267 million, which was the number in the fourth quarter of last year. And that's because the gross to net always gets a little bit worse in the first quarter versus the previous quarter. As far as the year goes on, our investments and so forth. Now at this moment, we continue to push in adult. So it doesn't mean we're neglecting pediatric, absolutely not. But we continue to push in adults, especially in female adults. We've signed up some really great influencers and have partnership with like Busy Philipps, which we announced very recently. She's talking about ADHD and her experience in ADHD and her experience with Qelbree as a product that has helped her tremendously. So we hope to continue the market education and encourage patients to step forward and talk about their disease, about their conditions, about the things that they struggle with every single day and let them know that there are options out there. And these actions don't have to be stimulants. They don't have to be controlled substances and they can be a very good well-tolerated non-stimulant that can be very effective, which is the case with Qelbree. In every metric, we will look at Qelbree and as time goes on, we have more and more data and more evidence that the product really works and it really works fast, and it works well with kids and adults. So we will continue to invest in these areas. And clearly, as we get closer to the back-to-school season, we'll make more investments and more prioritization of resources around the back to school season. Regarding SPN-817 and the profile. Again, I mean, we will review, of course, the data on May 20 -- 23rd of May. I mean clearly, you want a product that works. I mean, at the end of the day, when you look at epilepsy and the landscape, there are so many agents out there, and we've been in that space for so many years before with Oxtellar XR, Trokendi XR and even Carbatrol way back. And many patients that I referred to earlier, they become refractory, unfortunately and they don't respond to as many medication. And these patients end up on way more than one or 2 drugs eventually. And therefore, you need a drug that really works and works well. And hopefully, it works well so that you avoid having the patient to progress and even become refractive. I mean, clearly, that's the gold standard that you're looking for is to try to treat patients early and you make them responsive to these medications, they are responsive and their progress or the worsening of their condition is delayed as time goes on. So SPN-817, from what we've seen so far, looks like it's an effective medication. From the data we've shared earlier back in October R&D Day as well as some of the patients we had in Australia way back in the early study. So we hope to have a profile of a drug that actually works well. And again, in huperzine A, given its mode of action and so forth, if it does also have some procognitive attributes, that would be huge. That would be huge specifically in this patient population. So we will see, as the analysis, we're literally completing a lot of that analysis as we speak, given that we had a little bit more patients than we initially expected. And we'll share all of that on May 23.

And our next question comes from Annabel with Stifel.

This is Jack on for Annabel. So I know you've mentioned previously that about 30% of Qelbree patients are treatment naive and the other 70% are switches from existing therapies. Are there any differences in the responses that these two patient populations have to Qelbree when it comes to things like speed of effect onset? Essentially trying to ask here, is there a better onboarding strategy? Or do both populations perform identically once they initiate Qelbree?

Not really. I mean it's pretty remarkable, the consistency of the feedback we get from the field on whether the patient, first of all, is pediatric or is adult or where the patient has come from to the Qelbree franchise as far as the efficacy of Qelbree. It works fast, as I mentioned, earlier. I mean, between a week to 2 weeks, depending on whether you need to titrate, if you have an older patient, like an adolescent or you have an adult, obviously, you have to titrate. And whether the physician is titrating as on the label or they're titrating a little bit slower just because they choose to do that, right? But nevertheless, patients feel and they start seeing the improvements during the titration and during -- and fairly the onset of action is fairly quick. Actually, in some of the survey results that we have seen over time since we launched this product, physicians who use Qelbree and have used Strattera for many years, they tell you Qelbree works within a week to 2 weeks. And on an average Strattera at least 4 or 5 weeks, I think even they've known it themselves that they see, given the experience they've had with Strattera. So we know that the product is working really well, regardless of whether you're a switch or you are completely a naive or new patients who got on Qelbree from the beginning.

Got it. And then just kind of to ask one more. Speaking about physician feedback. So I know that you're looking at Qelbree in the comorbid mood symptoms, more formally in the Phase IV, and we're going to see that data eventually. But in the meantime, have you heard any anecdotal or real-world reports from physicians maybe not involved in the trial about how Qelbree might be performing in this kind of patient population?

We actually first started hearing about it interestingly even way back when we were doing the studies from some investigators who at that time -- again, anecdotally, this was nothing like formal data collection or anything, anecdotally telling us we see -- and that was blinded even on top of it. So we don't know whether the patient they're talking about is taking Qelbree or taking placebo at that time, but they were telling us it looks like their patient is not just getting better because they can pay more attention or focus or whatever, they're just feeling better overall in general. So it's more about the whole mood of the patient, the whole well being of the patient, not just focus attention for impulsivity or hyperactivity or anything specific to ADHD. And we would have these investigators on that, say, do you know why, do you have an idea. And then again, not knowing what that patient whoever they are referring to, we don't even know they could be on placebo. But not knowing it, clearly, we would tell them what they get of the molecule that is being an antidepressant and so forth and then, of course, they say, oh, okay, and the molecule works on serotonin and so forth. So then they really speculate, of course, in their mind that yes, maybe that's why it is working better across different modes orders that these patients may have because we know ADHD does come with a lot of comorbidity for things like anxiety, depression, bipolar, other mood disorders. And clearly, it looks like, again, anecdotally, that probably it was helping across different areas, not just ADHD.

This concludes our question-and-answer session. I would now like to turn it back over to Jeff for closing remarks.

Thank you. In concluding our call this afternoon, we remain focused on, first, driving the long-term growth of the company by continuing to drive significant growth with Qelbree, and together with GOCOVRI and the rest of the portfolio, generate strong cash flows, allowing us to continue our investments in our pipeline. And second, progressing our innovative R&D portfolio of differentiated first-in-class molecules that have several exciting and upcoming clinical milestones and catalysts. Thanks for joining us this afternoon. We look forward to updating you on our next call.