Supernus Pharmaceuticals, Inc. Q4 FY2024 Earnings Call

Good afternoon, and welcome to Supernus Pharmaceuticals Fourth Quarter and Full Year 2024 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 Vozzo of ICR Healthcare, Investor Relations representative of Supernus Pharmaceuticals. You may now begin.

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. 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 of you who may be listening to the replay, this call is being held and recorded on February 25, 2025. 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.

Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us on today's call. Our 2024 results reflect solid commercial execution across the company, including continued growth of our core products and strong growth in operating earnings. Our performance in 2024 underscored our emphasis on growing our core business despite the loss of exclusivity on both Trokendi XR and Oxtellar XR. Total revenues excluding Trokendi XR and Oxtellar XR increased by 25% for the full year 2024. Driving this growth was Qelbree's robust performance with 25% growth in annual prescriptions as reported by IQVIA and 72% growth in annual net sales. In the fourth quarter of 2024, prescriptions reached another all-time quarterly high of 214,600 prescriptions. In 2024, Qelbree's annual prescription growth outpaced that of the ADHD market that grew by 9%, reaching 103 million prescriptions. Qelbree's back-to-school momentum carried through the fourth quarter with sequential prescription growth of 11% compared to the third quarter. This prescription growth enabled Qelbree to have a strong fourth quarter with net sales reaching $74 million, representing a 60% increase over the fourth quarter of 2023. In 2025, Qelbree is off to a good start with exciting news about the FDA approval of its updated label. The new label further elaborates and differentiates Qelbree's mechanism of action as a novel nonstimulant, reinforcing its multimodal pharmacodynamic profile and highlighting its unique partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the norepinephrine transport. Also, the label is now updated with new and important lactation data for breastfeeding women with ADHD. Such information is crucial for the important and growing adult female patient segment. In addition, earlier this month at the annual national psychopharmacology update conference, Supernus presented interim results from an open-label Phase IV trial with Qelbree in adult patients with ADHD and mood disorders. Interim data for the first 95 patients who completed the trial show improvements in clinician- and patient-rated measures of ADHD, depression and anxiety symptoms. The data are encouraging and suggest that the effects of Qelbree may extend to adults with complex ADHD. The safety outcomes in the trial were consistent with the double-blind pivotal trial of Qelbree in adult ADHD. 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. 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 Qelbree. This extends the original expiration date of that patent to the year 2025. Regarding GOCOVRI, for full year 2024, net sales increased by 9% compared to 2023 and by 15% in the fourth quarter of 2024, reaching $37 million. Earlier this month, the FDA approved ONAPGO, Supernus' 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. We are targeting the launch of ONAPGO in the second quarter of 2025 with a support team of experts, including a nurse education program and access support. ONAPGO fits very well within our portfolio as it utilizes our existing Parkinson's disease sales force and infrastructure. Switching to our legacy products, the first generic for Oxtellar XR entered the market in early September 2024, resulting in both a year-over-year and sequential quarter-to-quarter decline in net sales of Oxtellar XR in the fourth quarter 2024. For full year 2024 combined, net sales of Trokendi XR and Oxtellar XR were down 22%. In 2025, we expect further erosion in both product sales with combined net sales to be in the range of $65 million to $75 million. Moving on to our CNS pipeline of novel product candidates. In November 2024, we reported topline results from an open-label Phase IIa study with SPN-817 in patients with treatment-resistant seizures. The study suggested a differentiated profile with strong efficacy in focal seizures at the 3-milligram and 4-milligram twice-daily doses. 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. 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 company has initiated a Phase IIb randomized double-blind placebo-controlled study of 3-milligram and 4-milligram twice-daily doses of SPN-817, targeting enrollment of approximately 258 adult patients with treatment-resistant focal seizures. Also, the company completed a pharmacokinetics study of two oral formulations of SPN-443 in healthy adults. Both formulations of SPN-443 showed adequate bioavailability and were well tolerated. SPN-443 is our new stimulant-like product candidate for ADHD and other CNS disorders. We recently disclosed that the Phase IIb study of SPN-820 in adults with treatment-resistant depression did not demonstrate a statistically significant improvement on the primary and secondary endpoints versus placebo. The safety profile of SPN-820 in the study was consistent with previous clinical trials showing few adverse events. We continue to analyze the data and we'll update you when we reach a decision regarding the future steps for the program. Finally, corporate development will continue to be a top priority looking for strategic opportunities to further strengthen our future growth through additional revenue-generating products or late-stage pipeline product candidates. With that, I would now turn the call over to Tim.

Thank you, Jack. Good afternoon, everyone. As I review our fourth quarter and full year 2024 results, please refer to today's press release and the 10-K filed earlier today. Total revenue for the fourth quarter of 2024 was $174.2 million compared to $164.3 million in the same quarter last year. Total revenue in the fourth quarter of 2024 was comprised of net product sales of $166.4 million and royalty, licensing and other revenues of $7.8 million. The increase in net product sales was primarily due to the increase in net product sales of our core products, Qelbree and GOCOVRI. Excluding net product sales of Trokendi XR and Oxtellar XR, total revenues for the fourth quarter of 2024 increased 29% compared to the same quarter of last year. For the fourth quarter of 2024, combined R&D and SG&A expenses were $108.1 million as compared to $104.6 million for the same quarter last year. Operating earnings on a GAAP basis for the fourth quarter of 2024 were $21.4 million as compared to an operating loss of $1 million for the same quarter last year. Recall during the fourth quarter of 2023, we booked a $20.2 million intangible asset impairment charge, reflecting the forthcoming loss of exclusivity of XADAGO in December of 2027. GAAP net earnings were $15.3 million for the fourth quarter of 2024 or $0.27 per diluted share, compared to GAAP 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 of intangibles, share-based compensation, contingent consideration, impairment charges and depreciation, adjusted operating earnings for the fourth quarter of 2024 were $48.3 million compared to $47.1 million in the same quarter last year. Total revenues for the full year 2024 were $661.8 million compared to $607.5 million in the same period last year. Total revenues were comprised of net product sales of $637.7 million and royalty, licensing and other revenues of $24.1 million. The 11% increase in net product sales was primarily due to the increase in net product sales of our core products, Qelbree and GOCOVRI. Excluding net product sales of Trokendi XR and Oxtellar XR, total revenues for full year 2024 increased 25% compared to last year. 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. Operating earnings on a GAAP basis for the full year 2024 were $81.7 million as compared to an operating loss of $5.3 million for the same period last year. The increase in operating earnings reflects the higher revenues and lower operating expenses in 2024. GAAP 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. On a non-GAAP basis, which again excludes amortization of intangibles, share-based compensation, contingent consideration, impairment charges and depreciation, adjusted operating earnings were $183.7 million compared to $125.1 million in the same period. This is an approximately 47% increase year-over-year. As of December 31, 2024, the company had approximately $454 million in cash, cash equivalents and marketable securities, compared to $271 million as of December 31, 2023. This increase was primarily due to cash generated from operations. It should be noted we have generated approximately $300 million in cash from operations in the past two years. Because of that, the company has a strong balance sheet with no debt and significant financial flexibility for potential M&A and other growth opportunities. Now turning to guidance. For full year 2025, we expect total revenues to range from $600 million to $630 million comprised of net product sales and royalty and licensing revenues. Note that total revenue guidance for full year 2025 assumes approximately $65 million to $75 million of combined net sales of Trokendi XR and Oxtellar XR. For the full year 2025, we expect combined R&D and SG&A expenses to range from $435 million to $460 million. Overall, we expect full year 2025 operating earnings in the range of $10 million to an operating loss of $15 million. And finally, we expect non-GAAP operating earnings to range from $105 million to $130 million. Please refer to the earnings press release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non-GAAP. With that, I will now turn the call back over to the operator for Q&A. Operator?

Thank you. Our first question comes from Andrew Tsai at Jefferies. Your line is open.

Hey, thanks for taking my questions. Good afternoon. Congrats on the nice quarter. A couple of questions to start. If we backed out other products from your 2025 revenue guidance with reasonable assumptions, is it fair to infer maybe you're thinking Qelbree this year could do maybe somewhere around $2.65 to $2.95? 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.

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

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

From a pipeline perspective, first, to clarify, SPN-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 as far as our decisions. Aside from that, our business development activities will continue to be a top priority at the company. From a priority perspective, first, commercial products—if we can bring in more revenue-generating products. Next priority would be mid-stage to late-stage pipeline assets. From a therapeutic perspective, we're agnostic between psychiatry and neurology. We're flexible there. We're even open to other therapeutic areas and have participated in certain processes looking at assets outside CNS, as long as the situation involves multiple assets, not just one asset in a whole new therapeutic area. If there is some scale, multiple assets, we would be interested in expanding beyond CNS. As Tim mentioned earlier, we have significant flexibility given our clean balance sheet and no debt. We have a strong cash position that we continue to add to. As far as deal size, it really depends on the situation. You could go large if the target brings in its own cash flows that support the leveraging situation. In total, deal sizes could range from $500 million to $1 billion or $1.5 billion depending on the situation and the cash generation of the target we're looking at.

Our next question comes from Stacy Ku at TD Cowen.

Thanks so much for taking our questions and congratulations on the progress. First question is on Qelbree. That performance in Q4, can you just walk through the variables driving strong pricing, especially as we head into 2025 — help us understand what you're thinking about gross-to-net this year? And then a second follow-up on Qelbree. Can you just talk about how the adult launch is progressing? And then, second question is on SPN-820. Are you able to give some idea of the timing of your strategic conclusions? Do you plan to make a decision this year? And then for the third question, for the ONAPGO 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.

I'll take them in order. On Qelbree, we had a very strong quarter in the fourth quarter. A big portion of that is clearly prescription growth; we grew 11% sequentially. As far as gross-to-net related to pricing, it did not change much recently. Gross-to-net on Qelbree has been fairly stable in the last three quarters, on the lower side of the range. Will it change in 2025? Yes. Q1 is typically worse from a gross-to-net perspective because of the increase in copay costs as we improve benefits to help patients through deductibles and so forth. For full year 2025, gross-to-net will probably be more in the 50% to 55% range; that's my current estimate and aligns with the range we discussed in November of last year. Regarding the adult launch, we're pleased with performance in adults across male and female patient populations. The product continues to perform well. We see more combination use in the adult population, meaning physicians are adding Qelbree to existing stimulants adults are on. Over time, they tend to reduce stimulant dose and increase Qelbree dose, with the ultimate goal of taking patients off stimulants completely where appropriate, but they do so gradually. Combination use in the adult population is around 35% to 40% of prescriptions. In the pediatric side it's lower, around 15% to 20% combination use. We're encouraged by adult performance and will continue to push forward because the need is tremendous. We believe patients do not have to start on controlled substances if a non-stimulant works. Qelbree has shown effects within a week or two across subscales and patients are generally satisfied; adult satisfaction is around 80%. On SPN-820 and timing for next steps, we hope to make decisions in the next couple of months. It likely will not be later this year; we'll do it as early as we can. We think there may be reasons behind the Phase IIb results. We have analyzed cross-study comparisons and sub-analyses and nothing jumps out. One theory is dosing regimen—perhaps intermittent dosing is more effective biologically than frequent daily dosing for affecting the mTORC1 system relevant to depressive symptoms. We'll dig deeper into that hypothesis and analyze the data further before communicating next steps. Regarding ONAPGO, the launch will likely be a slow build. That said, many KOLs have been waiting for this product and there may be an initial bolus of patients at launch followed by a slower rate. All promotional efforts will be centered around advanced patients. As for guidance, we do not have much embedded for ONAPGO; it's really a mid- to high-single-digit contribution for this year, so not a large portion of 2025 guidance.

If I could, just quickly follow up. What share are you at for the adult segment right now in 2024, meaning of Qelbree prescriptions, what percentage is adult?

Adult is in the 30% to 32% range; it bounces around quarter to quarter depending on seasonality. That is basically the reverse of how the market splits. The market is about 33% pediatric and 67% adult, so we still have a lot of room to grow on the adult side.

Understood. And now for SPN-820 and timing?

Regarding SPN-820 next steps, we hope to do that in the next couple of months. We could possibly move earlier, but it will not be later this year. We do think we have potential explanations for the results, and we'll continue to analyze the data. As I mentioned, dosing regimen could be a factor. There's a theory that intermittent dosing, rather than daily frequent dosing, might be needed for the mTORC1 system to function and regulate depressive symptoms. We'll investigate further and communicate our decisions as soon as possible.

Yes. For ONAPGO, could you repeat what needs to be done to be ready and confirm if any sales expectations are embedded into guidance?

To prepare for ONAPGO, we are building a support team including nurse education and access support and leveraging our Parkinson's disease sales force and infrastructure. The launch trajectory will likely be a slow build with the possibility of an early bolus from KOLs who have been waiting for the product. For 2025 guidance, we do not have significant sales expectations embedded for ONAPGO; it's a mid- to high-single-digit contribution for this year.

Our next question comes from Annabel Samimy of Stifel.

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

The label for ONAPGO is for advanced Parkinson's disease. The definition of "advanced" may vary among KOLs. For some, advanced could mean patients diagnosed 10 years ago who have tried many oral adjunctive therapies and are approaching options like deep brain stimulation, and those could be candidates for ONAPGO. For others, a patient diagnosed three or four years ago but struggling on oral agents might be considered. All promotional activities will be centered on advanced patients. Regarding overlap between ONAPGO and Apokyn, ONAPGO provides all-day continuous infusion of apomorphine for all-day control, whereas Apokyn is for acute episodes as a single injection. There is distinct positioning and use for the two products. There may be some overlap if patients are taking multiple Apokyn injections in a day and consider switching to the pump, but overall the products serve different needs. Apomorphine differentiates from oral dopamine agonists in receptor binding profile and affinity to D1 through D5 receptors. Apomorphine acts directly on dopamine receptors and does not need to be converted to dopamine, which can be an advantage over levodopa, which requires conversion and neuron function. We believe apomorphine will differentiate well clinically and tolerability-wise. Comparisons to other approved pumps should be done by reading labels and making individual clinical assessments.

Our next question comes from David Amsellem of Piper Sandler.

Thanks. Just a couple for me. First, on ADHD and Qelbree specifically, how are you thinking about the competitive landscape to the extent that other non-stimulants enter the market? We're going to get a data readout for solriamfetol in adult patients, for instance, in the not too distant future. So how are you thinking about competitive landscape, not just in terms of volumes, but how that might impact the payer landscapes and your gross-to-nets going forward? Second, have you announced pricing for ONAPGO? If you haven't, can you tell us where you think it could be as a point of reference relative to AbbVie's VY-ALE? Thanks.

Regarding ADHD and the competitive landscape, it's hard to comment until we see the labels and the data from these products. We haven't seen Phase III data for the other products you mentioned, so it's premature to assess their competitiveness versus Qelbree. Whether they will impact the payer landscape remains to be seen. We remain disciplined with payers and will do what's right for Qelbree. Qelbree brings clear differentiation, and we have a significant head start in the non-stimulant category as the first novel non-stimulant in decades. We are pleased with the coverage the product has today and in the foreseeable future. On ONAPGO pricing, the price is public at this point and we believe it is within a competitive range in the marketplace. That's all I can say on that.

Our next question comes from Kristen Kluska at Cantor Fitzgerald.

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 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 believed in this and talked about the data and have had anecdotes from physicians in the past.

ADHD is well known to often present with significant comorbidities such as mood disorders including depression, anxiety and bipolar disorder. Reported percentages range from as many as 40% to 60% of ADHD patients having significant comorbidities. These comorbidities are an issue because stimulants can be contraindicated or can exacerbate mood symptoms, which is why many adults are on non-stimulants. We are pleased the label acknowledges that viloxazine is different from atomoxetine and has a unique multimodal pharmacodynamic profile, including activity on serotonin, which differentiates the molecule. We cannot promote beyond the label, but the scientific information helps physicians understand the drug's activity. Physicians have been seeking clarity around serotonin activity because of concerns like serotonin syndrome and safety interactions. We are also encouraged by the open-label study in adults with ADHD and comorbid mood disorders, and we encourage folks to look at the poster presentation at the conference in May.

Okay. Thank you for that. And then on the BD front, can you talk about therapeutic areas and spaces that you think are promising and where you can leverage some of your in-house capabilities?

We look for areas that have scale. They do not have to be adjacent to CNS, but we prefer situations that provide multiple assets from day one rather than a single product in a completely new therapeutic area. That helps provide scale and efficiency and allows operations from R&D through commercial execution to be effective. Examples could include dermatology, ophthalmology, urology or other specialty areas where a reasonable, relatively small sales force can be effective. We also have strong infrastructure to support rare and orphan diseases, particularly in Parkinson's, where our existing capabilities are well suited. Those would be areas of interest.

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

Thank you. In concluding our call this afternoon, we thank you for joining us to learn about our strong operating performance in the fourth quarter and full year 2024. The company has executed well through a multiyear transition and the loss of exclusivity on two of its legacy products. Excluding our legacy products, Trokendi XR and Oxtellar XR, we continue to deliver robust double-digit growth in revenues. The company continued to generate strong cash flows behind the strength of its portfolio, particularly its core products, and to the efficiency of its operations. As a result, and as we mentioned earlier, we finished the year in a position of financial strength with $454 million of cash on the balance sheet and no debt. We believe we are well positioned for continued growth beyond the current transition and are focused on several key areas. First, driving growth and generating strong cash flow from our core products, particularly Qelbree, allowing us to continue our investments in our pipeline. Second, the launch of ONAPGO in the second quarter of this year. Third, advancing our innovative R&D portfolio of differentiated first-in-class molecules. 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.

Thank you for your participation in today's conference.