Supernus Pharmaceuticals - Q2 2024

Transcript

Operator (participant)

Good afternoon, and welcome to the Supernus Pharmaceuticals second quarter 2024 financial results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will follow at that time. As a reminder, this conference call is being recorded. I would now like to turn the conference over to Peter Vozzo of ICR Westwicke, investor relations representative for Supernus Pharmaceuticals. You may begin now.

Peter Vozzo (Investor Relations Representative)

Thank you, Corinne. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals second 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. This 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 of you who may be listening to the replay, this call is being held and recorded on August 6, 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'll now turn the call over to Jack.

Jack Khattar (CEO)

Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us on today's call. In the second quarter of 2024, we delivered strong net sales growth from our key growth drivers, Qelbree and Gocovri , and continued to advance our product pipeline, including SPN-817 for treatment-resistant seizures and SPN-820 for depression. Total revenues, excluding Trokendi XR and Oxtellar XR, increased 32% in the second quarter. Driving this growth was Qelbree's strong performance, with 26% growth in prescriptions, as reported by IQVIA, and 92% growth in net sales. Prescriptions reached an all-time quarterly high of 184,342, and net sales were $59 million.

In the first six months of 2024, Qelbree prescriptions grew by 28% compared to the same period last year, and net sales were $105 million, representing an 84% growth over the same period last year. Growth in net sales of Qelbree in the second quarter of 2024 benefited from both prescription growth and gross to net improvements compared to the same period last year. Gross to net deductions during the second quarter of this year were below our target range of 50%-55%. We saw a more favorable product returns trend, with initial launch batches experiencing lower return rates than assumed and continued lower co-pay deductions in the quarter.

As a result, for the remainder of 2024, we expect the gross to net for Qelbree to be in the 45%-50% range, with fluctuations that you would typically expect on a quarterly basis. During the second quarter, Qelbree also expanded its base of prescribers, ending the quarter with approximately 28,326 prescribers, up from 27,138 in the first quarter of this year. Prescriptions from adult patients now account for approximately 32% of Qelbree's total prescriptions. Switching now to Gocovri , net sales increased to $32 million in the second quarter of 2024, representing a healthy increase of 10% over the same period in 2023 and reflecting recovery from some of the negative factors the brand faced in the first quarter of 2024.

As you recall, earlier this year, we saw a significant increase in sample distribution by physicians to patients to help them through their out-of-pocket expenses in the first quarter. This negatively impacted our prescriptions in the first quarter, but reversed in the second quarter as patients started transitioning from their samples to refilling their prescriptions. Switching to our legacy products, Oxtellar XR net sales for the second quarter 2024 were $30 million, compared to $24 million in the second quarter of last year. And for Trokendi XR, second quarter net sales were $17 million, down by 12% from the same quarter last year. For the first six months of 2024, net sales of Trokendi XR were down 39%. We expect further erosion in Trokendi XR sales and the entry of Oxtellar XR generics later this year.

Given the trends in the first half of 2024, we now anticipate combined net sales of Trokendi XR and Oxtellar XR in 2024 to be in the range of $135 million-$145 million. Regarding SPN-830, we resubmitted the NDA last week and expect to learn from the FDA in a few weeks whether this submission will be considered as a Class 1, requiring a two-month review, or Class 2, requiring a six-month review. We remain committed to Parkinson's patients who need this potential new treatment option. Moving on to our CNS pipeline of novel product candidates, we have exciting catalysts coming up in the next six to 12 months. For 820, the company expects to provide data from its phase II-B study in adults with treatment-resistant depression in the first half of 2025.

3/4 of the targeted number of patients are now enrolled in the study. Also, enrollment in the phase II open-label study in patients with major depressive disorder is ongoing, and top-line results from that study are expected by the end of this year. In May 2024, we announced data from the planned interim analysis of our exploratory open-label phase II-A study of SPN-817 for treatment-resistant seizures. The interim analysis was based on 41 enrolled subjects, of which 19 completed the maintenance period at that time. We continue to expect top-line results for the full study in the second half of this year. In addition, a phase II-B randomized double-blind placebo-controlled study with SPN-817 in patients with treatment-resistant focal seizures is expected to start by the end of 2024.

Also, we plan to initiate a phase I single-dose study of SPN-443 in healthy adults following submission of an IND. SPN-443 is our newest 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.

Tim Dec (CFO)

Thank you, Jack. Good afternoon, everyone. As I review our second quarter 2024 results, please refer to today's press release and 10-Q that were filed earlier today. Total revenue for the second quarter of 2024 was $168.3 million, compared to $135.5 million in the same quarter last year. Total revenue in the second quarter of 2024 was comprised of net product sales of $162.5 million and royalty, licensing, and other revenues of $5.8 million. The increase in net product sales was primarily due to the increase in net product sales of our growth products, Qelbree and Gocovri , as well as Oxtellar XR.

Excluding net product sales of Trokendi XR and Oxtellar XR, total revenues for the second quarter of 2024 increased 32% compared to the same quarter last year. For the second quarter of 2024, combined R&D and SG&A expenses were $112.1 million, as compared to $111.2 million for the same quarter last year. The slight 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 earnings on a GAAP basis for the second quarter of 2024 was $22.6 million, as compared to an operating loss of $17.6 million for the same quarter last year. Income tax expense in the second quarter of 2024 was $6.4 million.

GAAP net earnings was $19.9 million for the second quarter of 2024, or $0.36 per diluted share, compared to a GAAP net loss of $831,000 or $0.02 loss per diluted share in the same quarter last year. On a non-GAAP basis, which excludes amortization intangibles, share-based compensation, contingent consideration, and depreciation, adjusted operating earnings for the second quarter of 2024 was $45.5 million, compared to $10 million in the same quarter last year. Total revenues for the six months ended June 30, 2024, were $312 million, compared to $289.3 million in the same period last year. Total revenues were comprised of net product sales of $301 million and royalties, licensing, and other revenue of $11 million.

Compared to second quarter 2024 results, the 12% increase in net product sales was primarily due to the increase in net product sales of Qelbree, Gocovri , and Oxtellar XR. Excluding net product sales for Trokendi XR and Oxtellar XR, total revenues for the six months ended June 30, 2024, increased 22% compared to the same period last year. Combined R&D and SG&A expenses for the six months ended June 30, 2024, were $223.5 million, as compared to $218 million for the same period last year. Again, this increase was primarily due to R&D expenses associated with clinical programs for SPN-817 and SPN-820, as we continue to progress our pipeline.

Operating earnings on a GAAP basis for the six months ended June 30, 2024, were $19.4 million, as compared to an operating loss of $12.4 million for the same period last year. That is a $31.8 million increase in operating earnings compared to the same period last year. For the six months ended June 30, 2024, we reported income tax expense of $6.5 million. GAAP net earnings were $20 million for the six months ended June 30, 2024, or $0.36 per diluted share, compared to $16.1 million or $0.29 per diluted share in the same period last year. On a non-GAAP basis, which again excludes amortization intangibles, share-based comp, contingent consideration, and depreciation, adjusted operating earnings were $67.7 million compared to $40.5 million in the same period last year.

That is a 67% increase in adjusted operating earnings compared to the same period last year. As of June 30, 2024, the company had approximately $347.2 million in cash, cash equivalents, and current and long-term marketable securities, compared to $271.5 million as of December 31, 2023. This increase was primarily due to cash generated from operations. It should be noted that we have generated approximately $200 million in cash from operations in the past eighteen months. Because of that, the company has a strong balance sheet with no debt, with significant financial flexibility for potential M&A and other growth opportunities. Now, turning to guidance. For full year 2024, the company raises its financial guidance for total revenue and GAAP and non-GAAP operating earnings, while reiterating combined R&D and SG&A expenses.

As a result, we expect total revenue to range from $600 million-$625 million, up from the previous range of $580 million-$620 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-$460 million. Overall, we expect full year 2024 GAAP operating earnings to range from breakeven to $20 million, and non-GAAP operating earnings to range from $100 million-$125 million. Please refer to the earnings press release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non-GAAP. With that, I will now turn the call back over to the operator for Q&A.

Operator (participant)

Thank you. At this time, we will now conduct a question-and-answer session. To ask a question, you need to press star one, one on your telephone and wait for your name to be announced. To withdraw your question, please press star one, one again. Please stand by while we compile the Q&A roster. Our first question comes from Andrew Tsai of Jefferies. Your line is now open.

Andrew Tsai (Managing Director)

Hi, good afternoon. Congrats on the nice quarter. Thanks for taking my questions. The first one is on SPN-830, the apomorphine pump. Congrats on resubmitting that. Just wanted to gauge your level of confidence it will be approved this time. It's kind of interesting since we know the competitor also received a CRL recently. So maybe talk about your level of confidence about this. Thanks.

Jack Khattar (CEO)

Yeah, sure. A couple of things. I mean, the first time we got a CRL, I try to give the example, it probably was, you know, a few pages. This time we got the CRL, it was maybe half a page, you know, give or take, just to make an example of the number of issues we're dealing with. So certainly, with this resubmission, the number of issues we're dealing with was much, you know, lower number of items and issues that we had to address. The second thing is we did have a meeting with the FDA, you know, before the resubmission to make sure we have the fullest, you know, level of confidence before we resubmit. So we feel pretty good about the filing right now and our chances of getting approved.

Of course, as I mentioned in our remarks, what we're still not sure about is whether it will be a, you know, Class 1 or Class 2 resubmission, but hopefully we'll have that piece of information in the next few weeks when the FDA accepts the filing and assigns a PDUFA date for the review.

Andrew Tsai (Managing Director)

Makes sense. Thanks. And shifting to 817, we're going to have the full phase II-A data cut later this year. Can you remind us, I think, 19 of 41 patients completed the maintenance period. How many more patients do you think will be completing that maintenance period, and how many more specifically at the 3-4 mg dose, the high doses?

Jack Khattar (CEO)

Yeah, at that time, back in May, when we reported the interim results, in addition to the 19, we had about seven or eight, if I remember the number correctly, of patients who were still in the study at various stages. So we would expect, you know, when we report the full results, to have, you know, at least another maybe, I don't know, five, six, depending on how many discontinue or how many stay in all the stages of the study. But we should have a, you know, a good handful of people in addition to the 19 that we will report on. So that will complete the initial portion of the study, just to clarify. The second portion was the extension, which we talked about back in May, where we are going to test a couple of strategies.

One of them is adding an antiemetic where, you know, we try to address the nausea and so forth. So that portion of the study has already started, but we won't have data in the fourth quarter or before year-end, for this year. Just to clarify that. There are two different pieces of the study. The initial one, which we will report on, but the extension, which we added in May, we will not have the data to report on that.

Andrew Tsai (Managing Director)

Okay. And then last one is on 820, the depression asset. You're having topline data in 40 patients with MDD later this year. Can you just remind us how long this study is, and what kind of MADRS or HAMD efficacy benefit you wanna see at the end of the study? What would be positive data to you and why? Thank you.

Jack Khattar (CEO)

Yeah, I mean, this is a short study. I think it's about 10 days treatment, so it's not a very, long study. It is open label, about 40 patients that we're, you know, targeting. So we think we have a very good chance we will be able to report before year-end. And as far as, I mean, the number of, or the reduction in the scales and what would we expect, of course, the larger, the better, especially that it is open label, so we would hope to see certainly, a large, improvement on MADRS versus if it were a placebo-controlled.

Andrew Tsai (Managing Director)

Thanks again.

Operator (participant)

Thank you. Our next question comes from David Amsellem of Piper Sandler. Your line is now open.

David Amsellem (Senior Research Analyst)

Thanks. Couple of questions on Qelbree. So with the back-to-school season coming up, help us understand your expectations for acceleration in volumes, particularly with the different gross-to-net framework that you've been talking about. And also in the context of, I believe, last back-to-school season, the Rx growth was, or acceleration was, a bit muted. So help us understand how you're thinking about this year's back-to-school season. That's number one. And then number two is the how much of the growth, you know, through the back half of the year is, the year-on-year growth is volumes, and how much of it is improvement in gross to net. And just help us better understand how we should be thinking about Qelbree.

In other words, what I guess I'm trying to get at is, is Qelbree a volume growth product going forward, or is a lot of the growth that's being captured really just a function of improved economics? And not just applicable to this year, but also how you're thinking about the product beyond this year. Thanks.

Jack Khattar (CEO)

Yeah, I mean, as an overall comment on the prescription growth of Qelbree, I mean, as we mentioned in the first half, we grew by about 28%. So we continue to expect to have, you know, robust growth in prescriptions versus last year. As far as specifically the back-to-school seasons, you're absolutely right. Last year, overall, the market, the ADHD market, there was a much softer back-to-school season than normally we would see. And actually, looking at year-to-date ADHD market growth, this year so far, it's up 8% in 2024 year to date in the first half of this year, versus 2023. And if you might remember, the ADHD market grew only by 3% in 2023 in total.

So this year already is showing a recovery in the market, in the overall market in general, at least in the first half of 2024, you know, at a much higher growth rate than last year. So I'm hoping, you know, that the back-to-school season would be back to what normal growth would be versus what happened in 2023. I mean, in 2023, we actually, you know, saw some decline, actually, in the ADHD market. With the measurement that we talked about it back then, which was June through September, you know, was not necessarily a calendar quarter, to get a better feel for what happened in the back to school, while Qelbree continued to grow last year, and it grew by about 19% in the back-to-school season.

So I'm hoping that the market does better, and of course, that means we will also do better than we did last year as far as growth. But the short answer, I mean, to your question is, the growth in Qelbree is not just improvement in gross to net. Certainly, we continue to have robust growth. I mean, we're already in year four in the, as far as the launch of this product, and we're still delivering 20%+ growth in prescriptions. And from a penetration perspective, we still have a lot of room to go here as far as the potential of this product and its penetration in the market, adult and pediatric at the same time. Hopefully, that touches on all the questions.

David Amsellem (Senior Research Analyst)

Yeah, and if I just make sneak in a quick follow-up. The gross to net, I mean, it's you know, getting below 50%, I mean, which is you know, better than what you had cited as a target in the past. I mean, is the that 45%-50%, you know, and just to be clear, that's your view of steady state gross to net over the long term for the product? Or, and maybe I'll ask it differently: Is there room for you know, even further improvement?

Jack Khattar (CEO)

Yeah, I mean, what I referred to in my prepared remarks, which was the issue of return, just to explain it a little bit more. Typically, when you first launch a product, you know, you make an assumption on how much of these initial batches that you ship out, you know, how much of those could potentially come back at some point from a return perspective... and you book it, you know, you enter, you know, in your books as far as potential liability accruals, what have you, on these returns. And then as time goes on, these batches, they will either be consumed or they expire because time goes on, and they have a certain fixed expiration date. So as they approach or go beyond the expiration date, basically, they're not gonna be returned anymore.

Or if you do have much lower experience from a return perspective versus the initial assumption, that's when you can, you know, take back some of that. So these are things that could potentially continue that way. I mean, there is a possibility we continue to benefit from that trend in the next quarter or so. So it may not be a one-time, but we can only see that when we get the data, you know, every quarter. And therefore, to back to your question, on an ongoing basis, would the target be 45%-50%? I sure hope so. I mean, I sure hope that next quarter gives us even more confidence, and in that case, we will, you know, we would emphasize or confirm that that probably is our long-term target versus the 50%-55%.

David Amsellem (Senior Research Analyst)

Okay, that's helpful. Thank you.

Jack Khattar (CEO)

Sure.

Operator (participant)

Thank you. Our next question comes from Stacy Ku of TD Cowen. Your line is now open.

Stacy Ku (Biotechnology Equity Research Analyst)

Wonderful. Thanks so much for taking our questions. What a great quarter for Qelbree and just a solid net value for prescription. So we have a few follow-ups. Just for Q1, can you just talk a little bit more about what approach you're trying to do to grab share in the back-to-school season? So just to clarify, you said the next quarter or so, you could see a benefit in gross-to-net, but do you think any of these back-to-school plans could impact the gross-to-net in Q3? So this is the first question. And then, to ask the question a little bit differently, how do you think about your comfort with the $200 million-$220 million consensus rates for Qelbree that you've kind of commented on in the past?

Could this be exceeded as we think about this is solid gross-to-net improvements? And then last question is on the adult growth. Talked about the 30%-20% split, but is this driving the net pricing? Are you seeing kind of encouraging growth, and how should we think about the remainder of the year as you think about really trying to drive that adult launch as well? Thank you so much.

Jack Khattar (CEO)

Yeah. On the first question, as far as the back-to-school programs, I mean, it's fairly intense as far as the level of support that we will be going out with and the momentum that we will be building and are building actually as we speak right now in preparation for the back-to-school season. So we will put a lot of investment and effort behind, you know, the season, given the importance of the season for the whole year, for the brand in general. At the same time, you know, we're not neglecting the adult segment, you know, a portion of the business, of course, in Q3, but the top priority is clearly children and pediatric because of the back to school.

As far as the, you know, annual, you know, so to speak, soft guidance or whichever way you wanna, you know, describe it, the $200 million-$220 million, I mean, clearly, in the first six months, we did $104.5 million or $105 million. You know, double that is $210 million, and of course, you got to add some growth to it. So clearly, we feel comfortable with that range. Is it gonna be a little bit closer to the upper range? Hopefully. Again, it all depends on the back-to-school season, you know, which is a lot of what we've been talking about today.

If the back-to-school season is really strong this year and not soft like it was last year, maybe we will be closer to the upper end, you know, upper end, of that range on, on Qelbree. And then finally, I mean, in the first, you know, on the, in this past quarter, in the second quarter, to give you an idea, our adult prescriptions or business grew by about 26%. The pediatric grew by about 22%, 23%. So, we had put some more emphasis on the adult, patient population in the second quarter, as times.

We are experiencing a little bit more growth in adult, but again, on a quarter-to-quarter basis, as I mentioned earlier or in previous calls, sometimes we on purpose shift the emphasis one quarter versus another, depending on the seasonality and the importance of that specific patient population.

Stacy Ku (Biotechnology Equity Research Analyst)

Incredibly helpful. Thank you.

Operator (participant)

Thank you. Our next question comes from Annabel Samimy of Stifel. Your line is now open.

Annabel Samimy (Managing Director)

Hi, thanks for taking my question, and great quarter on Qelbree. I just wanna put a finer point on the adult versus pediatric. To what extent is the adult population driving some of maybe the improved pricing? Obviously, they have higher doses, so potentially a higher price point. And given that that's where a good chunk of the growth was and some of your efforts had been lying in that area, can you maybe share some of the feedback that you're getting from the adult population? Is this an area that you can continue to push, and is there any pushback from the adults in terms of whether they're favoring a stimulant versus a non-stimulant, if they're still transitioning with lower doses than you expected, et cetera, et cetera?

I'm just trying to understand why, with the growth that you have, why it's still sitting at 32% of your total prescriptions, and also with the efforts that you were making last quarter. Thanks.

Jack Khattar (CEO)

Yeah, regarding the price points and so forth, I'll just give you a couple of numbers. I mean, these are more gross numbers, but for the adult, I mean, we estimate the average blended, you know, cost of prescription is around $615. By comparison, it's around $525 for pediatrics. So there is about 15%-17% difference between, you know, the price per prescription, pediatric versus adult. And that actually is obviously a result of the size of the prescription. So with adults, you normally have 50-52 tablets per prescription or capsules per prescription. You know, with pediatric, it's more around the 44-45 capsules per prescription. So these are some of the metrics.

Obviously, it does change over time, quarter to quarter, but that's where we are right now as far as the, you know, pediatric versus adult. As far as the feedback on the adult patient population, I mean, very consistent, fairly consistent with the pediatric, about the product, its performance, clinical benefits, all of the above. The tolerability and safety, I mean, very, very consistent across all patient populations, with both of them, you know, showing the growth and acceptance of the product. And by no means we are even anywhere close to saturate, you know, to saturation as far as our penetration rates. I mean, our market share in adult is very low, and we have a, you know, we have a huge, huge opportunity here for us to continue to push the product.

And again, as long as the product continues to perform, you know, we see no reason for it to slow down, and try to, you know, get a much higher market share penetration within the adult segment.

Annabel Samimy (Managing Director)

Got it. And maybe you can just share what your expectations are for the level of penetration you might have in that adult population in your. You know, either for the year or for the long-term outlook. Is this still gonna be a 32% type of. Well, I mean, is it gonna account still for about 32% of your prescriptions, or do you expect that number to continue to go up through the year?

Jack Khattar (CEO)

Yeah, I mean, we do expect it to go up eventually, whether through this year or next quarter or the quarter after, but more on a long-term basis. Definitely, we would expect, and we certainly will be working pretty hard, you know, to get that portion to be a bigger, you know, part of the mix. So will Qelbree end up being a 40% adult and 60% pediatric, where the market is pretty much 67% adult and 33%, you know, pediatric? Probably. I mean, we are a non-stimulant anyway in general, so you are going to have some bias of the business being a little bit more pediatric than adult in general, generally speaking. But certainly, you know, we are pushing pretty hard to get that 32% much higher as being part of the mix.

You know, as far as the adult in general, as I mentioned earlier, I mean, the satisfaction, the performance, everything is very similar to what we've seen with the pediatrics. So we see no reason why we shouldn't be able, you know, to continue to grow within the adult market. At this point, our market share within the adult market is around 0.3%. In pediatrics, we're in the 2%, you know, give or take. So we, you know, we continue to look for the whole brand, Qelbree. You might remember we talked about somewhere between 4%-5% market share, or could be as high as 10% market share of the total ADHD market. So we clearly have a long way to go here with Qelbree.

Annabel Samimy (Managing Director)

Okay, got it. And if I can just ask a quick question on SPN-830. I guess this is several times now through the review process. Are there any indications from FDA on the breadth of the population that might be included in the label? I'm not sure if you ever got to that point where you got to label discussions, but is FDA considering a broader label, or is it still mostly in the severe camp? Thanks.

Jack Khattar (CEO)

Yeah, I mean, at this point, it's really premature for us to make any comment on that because we haven't gotten that far as far as discussions. So we really don't know at this point.

Annabel Samimy (Managing Director)

Okay, great. Thank you.

Operator (participant)

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

Jack Khattar (CEO)

In concluding our call this afternoon, we thank you for joining us to learn about our strong performance in the second quarter and first half of this year. The company continues to execute remarkably well through a multi-year transition and the loss of exclusivity on two of its legacy products. The company has generated strong, positive cash flows behind the strength of its portfolio, particularly our growth products and the efficiency of its operations. In addition, we are excited about our progress on the pipeline across several programs. These programs will be generating significant data over the next six to 12 months. Thanks again for joining us this afternoon. We look forward to updating you on our next call.

Operator (participant)

Thank you for your participation in today's conference. This does conclude our program. You may now disconnect.