SUPN - NASDAQ

Good afternoon and welcome to Supernus Pharmaceuticals First Quarter 2025 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.

Thank you, Lauren. Good afternoon everyone and thank you for joining us today for Supernus Pharmaceuticals first quarter 2025 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 May 5, 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 first quarter results reflect once again double-digit revenue growth from our core products as well as solid growth in adjusted operating earnings. Total revenues, excluding Trokendi XR and Oxtellar XR increased by 26% in the first quarter compared to the same quarter last year. Driving this growth was the robust performance of both Qelbree and GOCOVRI. These 2 products collectively accounted for 67% of total net sales, while Trokendi XR and Oxtellar XR accounted for only 9% and 7%, respectively. In the first quarter, Qelbree grew by 22% in prescriptions as reported by IQVIA and by 44% in net sales. The product ended the first quarter in a strong position with monthly prescriptions in March reaching an all-time high of 75,277, up 25% compared to same period last year. In addition, we continue to expand the prescriber base for Qelbree with the number of prescribers in the first quarter reaching 34,416 which is up by 23% compared to first quarter last year. We are also excited about the new data from the open-label study in adults with ADHD and mood disorders. The data from all 161 adult patients will be presented at the American Psychiatric Association Annual Meeting later this month. The data showed significant improvements in clinician and patient-rated measures of ADHD, depression and anxiety symptoms and the safety outcomes in the trial were consistent with the double-blind pivotal trial of Qelbree in adult ADHD. Regarding GOCOVRI. For the first quarter of 2025, prescriptions increased by 12% and net sales increased by 16% compared to the same quarter last year. The Medicare Inflation Reduction Act with the reduced patient out-of-pocket costs drove increased prescriptions for GOCOVRI among Medicare patients in the first quarter compared to the same period last year. On average, GOCOVRI's Medicare co-pay declined by 42% compared to the first quarter of 2024 and by March 2025, 84% of GOCOVRI's Medicare prescriptions were costing patients less than $25. In addition, prior authorizations and medical exception approval rates remained high in the quarter. These new dynamics and the resulting growth in the first quarter suggest that any potential negative impact from increased mandatory Medicare manufacturer payments for the year could end up being offset by increased prescriptions and gross sales in Medicare. Early in the second quarter, we launched 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. It was launched with a support team of experts, including nurse education program and access support and utilizes our existing Parkinson's disease sales force and infrastructure. Initial response from physicians has been encouraging based on patient enrollment forms submitted early in the launch. And only a few weeks into the launch, more than 75% of the sales territories have generated one or more patient enrollment form with more than 100 prescribers submitting such forms. Switching now to our legacy products for the first quarter of 2025, combined net sales of Trokendi XR and Oxtellar XR were down 46%. For the remainder of 2025, we expect further erosion in both product sales and maintain our 2025 guidance of $65 million to $75 million in combined net sales. Moving on to our CNS pipeline of novel product candidates, we plan to initiate a follow-on Phase IIb multicenter randomized, double-blind, placebo-controlled trial with SPN-820 in approximately 200 adults with major depressive disorder. This study will examine the safety and tolerability of SPN-820 at a dose of 2,400 milligram given intermittently twice per week as an adjunctive treatment to the current baseline antidepressant therapy as well as assess the rapid onset of improvement in depressive symptoms. As we mentioned on our last call, we completed a pharmacokinetic study of 2 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. The company expects to disclose a lead indication for the trial for the product by the end of 2025. Regarding corporate development, continues to be a top priority for us looking for strategic opportunities to further strengthen our future growth with revenue-generating products or late-stage pipeline product candidates. And finally, given the current environment for tariffs, it is difficult to predict what impact, if any, they could potentially have on our business. We don't expect tariffs on finished products to impact Qelbree, Trokendi XR, GOCOVRI, ONAPGO or APOKYN as they are either manufactured in the U.S. or are under arrangements that shield us from impact of tariffs. On the other hand, MYOBLOC, XADAGO and Oxtellar XR finished products are manufactured in Europe or Canada and therefore, could become subject to import tariffs. All our products, raw materials are imported from various countries outside the U.S. Therefore, any potential impact from tariffs will highly depend on numerous factors, including but not limited to, current inventory levels of various raw materials, timing of any new orders that may be subject to the tariffs, the country of origin for the various materials and the applicable percentage tariffs. With that, I will now turn the call over to Tim.

Thank you, Jack. Good afternoon everyone. As I review our first quarter 2025 results, please refer to today's press release and 10-Q that was filed earlier today. Total revenue for the first quarter of 2025 was $149.8 million compared to $143.6 million in the first quarter of 2024. Total revenue in the first quarter of 2025 was comprised of net product sales of $142 million and royalty revenues of $7.8 million. This $3.5 million increase in net product sales was primarily due to increase in net product sales of our core products, Qelbree and GOCOVRI. Excluding net product sales of Trokendi XR and Oxtellar XR in both periods, total revenues for the first quarter of 2025 increased 26% compared to the first quarter of 2024. For the first quarter of 2025, combined R&D and SG&A expenses were $116.9 million as compared to $111.4 million for the prior year quarter. The increase was primarily due to higher R&D spend associated with our ongoing clinical programs as we continue to progress our pipeline. Operating loss on a GAAP basis for the first quarter of 2025 was $10.3 million as compared to an operating loss of $3.2 million for the prior year period. This increase was primarily due to higher contingent consideration loss related to the achievement of ONAPGO related milestones. GAAP net loss was $11.8 million for the first quarter of 2025 or a loss per diluted share of $0.21 compared to GAAP net earnings of $124,000 or earnings per diluted share of $0.00 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 2025 was $25.9 million compared to $22.3 million in the first quarter of 2024. As of March 31, 2025, the company had approximately $463.6 million in cash, cash equivalents and marketable securities compared to $453.6 million as of December 31, 2024. This increase was primarily due to cash generated from operations, offset by a $25 million payment of the ONAPGO related milestones in the first quarter of 2025. 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 the full year 2025, 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 $600 million to $630 million, comprised of net product sales and royalty revenue. 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 GAAP operating earnings loss in the range of $15 million GAAP operating loss to $10 million GAAP operating earnings and 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 to the operator for Q&A. Operator?

[Operator Instructions] Our first question comes from the line of Andrew Tsai with Jefferies.

This is John [ph] on for Andrew. Could you just please remind us the key growth drivers for Qelbree in 2025? And is it fair that 2025 will be more about volume than price? Or could sales still be driven by volume and price? And then could you just provide a little more color on your decision to move forward with 820 in MDD? Like what kind of placebo-adjusted efficacy delta do you think you could ultimately show? And then when can we expect data?

Yes. Regarding Qelbree, the growth is going to be combined, I mean, volume and a little bit of price. We took price increase, a very small price increase in January but the majority of the growth is going to be based on volume and growth in prescriptions. As we showed, I mean, we had a really good first quarter, although typically first quarter, you may see some -- a little bit slowdown in growth and so forth or you may see flattish trend in the first quarter. We're pretty happy with where we stand with Qelbree. As I mentioned in my remarks, March came in really high, all-time high of 75,000 plus as far as prescriptions are concerned which are 25% growth versus last year. So we're pretty optimistic on where the brand is and the position it's in in the first quarter and certainly look forward to more growth in the subsequent quarters. As far as SPN-820, regarding the expectation as far as placebo-adjusted improvement in MADRS and so forth, if you remember in the open label and it's very hard, of course, to make these comparisons because it was an open-label study, we had very significant reduction in MADRS and yet in the Phase IIb subsequently, we had placebo effect in the 12 point -- 10- to 12-point reduction in MADRS. So if you account for something of that nature and we can do a little bit more than the placebo by 5 to 8 points which is typically what is considered to be clinically and medically relevant and significant, that will be something that certainly we will be shooting for. So anything between around the 5 to 8-point reduction in MADRS placebo adjusted will be a clinically significant reduction and that's certainly -- we hope to get even more than that given the initial results that we had way back in the open label. And again, the reason we decided to do the follow-on study on 820 is because of the different dosing regimen. So we believe the mTORC1 mechanism is as such that this is a target that you don't have to hit very frequently every single day. But if you do it intermittently as we did back in the open label, we have a much better and higher chance of showing the impact of the drug.

And then when could we possibly expect data readout from the study?

Yes. At this point, we're looking -- and we're not promising this yet because there is a lot of work to be done in preparation for the new study. But at best case, we'll probably start the study before year-end this year. And therefore, we need a good 1.5 years to finish the study and get data. So depending on recruitment, of course and looking at 200 patients to be randomized. So depending on how quickly we can do that. Now it is MDD, so it should go a little bit faster than the TRD study. So that will remain to be seen. We'll certainly update folks as time goes on.

Our next question comes from the line of Stacy Ku with TD Cowen.

So the first is on Qelbree. Just how much of the normal seasonality or Q1 dynamics impacted Qelbree net pricing this quarter? And how should we think about the jump to Q2, the remainder of the year in terms of gross to net? And then maybe could you comment on the level of comfort you might have on Qelbree consensus around $290 million for the year? That's kind of the first question. And then the second question is on ONAPGO. As we think about the infrastructure required, maybe talk about the plumbing to make sure all start forms can be transformed into patient prescriptions, getting patients on drug. What are your thoughts on the timing to go from a start form to getting ONAPGO to the patient?

Yes. Regarding Qelbree, Q1, as we always discuss, typically tends to have pressure on the gross to net, clearly and the total net price per prescription. So in the first quarter, gross to net went up to somewhere in the early 50s, 51%, 52%, somewhere in that region which is very expected. And then typically, if we do follow the typical trends, it should see some improvement in the second quarter and third quarter unless there is a onetime issue that pops up that is unforeseen and that could cause quarter-to-quarter fluctuations. As far as the consensus of the $290 million annual, I mean, we feel comfortable with that number, although we, again, we don't give official guidance for product. But certainly, the product is doing very well and should do very well for the rest of the year. Regarding ONAPGO and the infrastructure, the infrastructure is very well established clearly because of the few years now we've been in this space in Parkinson's with APOKYN and GOCOVRI. So the whole infrastructure from sales force to the hub services, nurse educators, reimbursement health, all that has been already established and has been improved actually over the last several years in preparation as well for ONAPGO. So it is a little bit hard right now because we just launched the product and we just started getting all the patient enrollment forms to give you a good idea as to how long the cycle would be from the patient enrollment form until the patient actually gets the product. But from our experience from GOCOVRI and APOKYN and so forth, we are well within the industry average, if not a little bit better. And the same thing goes with the prior authorizations or getting the actual reimbursements. So really how many out of the patient enrollment forms end up actually translating into actual product that gets in the hands of the patients. We typically run at a little bit better than industry average with our rates. It's north of the 40% to 50%. It's in that range. So we feel very optimistic about the process that we have and really making sure we can process these patient enrollment forms and get the product to the patient as soon as possible.

Our next question comes from the line of Annabel Samimy with Stifel.

This is Jack [ph] on for Annabel. So could you provide maybe some more details around reimbursement discussions and how we should think about the trajectory of launch for ONAPGO? Are there any points of differentiation that physicians are immediately looking towards compared to something like AbbVie's pump?

Yes. Regarding reimbursement, as I mentioned earlier, we expect a very good level and percentage of these enrollment forms to end up going through all the way and fulfilled -- actually fulfilled so that the patient ends up getting the product itself. We have complete support for that throughout the process right from the beginning, a patient enrollment forms gets written up. It's really a very high level of service and taking that form and really working it through with the hub services all the way to make sure that the reimbursement adjudication for all that insurance and everything works out as smooth as possible. And we had -- actually, before we really launched the product, so to speak, we had some early ones that we ran through the process to test the process and make sure it is smooth so that when the product first became available and some of these forms started flowing through, we had the process worked out. So we feel pretty confident about that. As far as the product differentiation, I mean the product, clearly, first of all, it's a very different molecule than anything that is out there, except for, of course, APOKYN. So apomorphine is a very strong potent molecule that works very well. It's a good dopamine agonist, probably one of the best out there. And it works really well. And we know that well from the efficacy and the data that came out of the study on ONAPGO as well as APOKYN in general, I mean, as a molecule. So it's the only pump clearly that provides that option to patients, continuous infusion of apomorphine. And a lot of patients out there don't have too many choices. And if you've been on levodopa/carbidopa for so many years, do you really want to have another product that gives you also levodopa/carbidopa or do you want to switch to something else that could be more beneficial. So this is really a decision that clearly the movement disorder specialists will make as appropriate for each patient they have. So there is a clear differentiation for the product also from safety, tolerability. You can take a look at the label of our product versus the label of the other products out there. It will show some clear differentiation. As far as efficacy, they're fairly comparable, the 2 products, not as much of a differentiation. So that's the general framework without having obviously head-to-head trials, it is very difficult to make these kind of comparisons.

Got it. And then if I could just ask one more. For SPN-820, was there anything you were able to gather from the Phase II in treatment-resistant depression that could either maybe revive that program and/or give you some extra comfort on the Phase IIb in major depressive disorder? Do you see that indication has likely dropped at this point? Or have you not finished going through that data?

Yes. We didn't see from all the data and everything that we've been doing since we announced the results, we didn't see anything that points to the fact that it's an indication-driven difference that we saw between the 2 studies. The key difference is the dosing regimen. So what I'm saying is, initially, we're going to go after MDD with a follow-on study. That doesn't mean we're giving up on TRD. So we think the product will work in both but MDD could be quicker as far as enrollment or what have you and that's why we chose to go with MDD at this point as a follow-on study. So we're not giving up on TRD because we think that the product mechanistically, if it works in MDD, it should work in TRD. And the only reason it didn't work in the Phase IIb most likely is because of the dosing regimen.

Our next question comes from the line of David Amsellem with Piper Sandler.

So just a couple for me. First on ONAPGO, I know these are early days but what are you hearing in the field regarding competitive dynamics versus Vyalev, the AbbVie product? And specifically, are you getting any pushback regarding the use of apomorphine in general when there is another subcu pump available that delivers levodopa and carbidopa? So that's number one. Just talk to the competitive dynamics and what you are seeing and expect to see. And then just turning to the pipeline on 443, I know you're going to disclose a lead indication by the end of this year. But since it is a stimulant, is it fair to say that sleep wake could be on the table here either narcolepsy or idiopathic hypersomnia or both? And how are you just thinking about that in terms of its fit for what you plan to do with that asset?

Regarding ONAPGO, all I can say is, initially and this is, again, very early. As I mentioned in our prepared remarks, we're very encouraged actually with the reaction to the product, the receptivity, the response from physicians and the level of activity that we've seen behind the product. So we also started to get some initial feedback regarding our Circle of Care which is our support system that we give our patients positive feedback. Again, clearly, we've had this program for a number of years right now. We've kind of perfected it, improved over the year. And we've had it for GOCOVRI and APOKYN and now we're applying it to ONAPGO. So we emphasize, of course, the level of service that we're giving our patients and our physicians. And we see that as a competitive advantage actually in the marketplace. And so far, all indications are very positive and very encouraging. I caution everybody because it's very early in the launch, of course, it's only a few weeks. But certainly, it's off to a very strong start, better than our expectations initially and hopefully will continue to be that way. And as far as, again, apomorphine versus levodopa/carbidopa, that is something that a physician will have to make that decision. I mean if you have a patient and these are patients that are advanced progress and that's really the patient type that you're looking at for these infusion devices. This is a patient who's been taking levodopa/carbidopa for 5 years, 10 years, 15 years, whatever the case might be, do you really want to put them back on levodopa/carbidopa. And with the other infusion device, because it is levodopa/carbidopa, you can't use it as an add-on to the oral levodopa/carbidopa. Basically, you have to replace the oral completely. But with our pump, because it is apomorphine, you could still continue to keep the patient on the oral levodopa/carbidopa while at the same time using ONAPGO infusion device that gives you apomorphine. So that's another clear differentiation between the 2 products. And being an add-on could prove to be a potential advantage. We will see in the marketplace. Regarding the pipeline and 443, we are looking at 443 as we have presented earlier a long time before as a stimulant -- potential stimulant for ADHD with potential Schedule 4 instead of C2 scheduling. So that would be a huge advantage in the marketplace. But we're also looking at it for other indications and that's why we haven't made the final, final selection of what indication will be the lead indication. So we could choose a lead indication and potentially other indications as well as a follow-on to the lead indication. So we're still finalizing now some of the work we're doing, some animal models and so forth and we'll make that decision before year-end. But it's a pretty exciting asset and it remains to be seen as to where we take it initially and then follow on with other indications potentially.

[Operator Instructions] Our next question comes from the line of Kristen Kluska with Cantor Fitzgerald.

This is Ian [ph] on the line for Kristen. On Qelbree, do you have a sense of the proportion of naive patients that are getting on an ADHD medication for the first time and they're deciding on taking Qelbree. And then you previously mentioned the combination use within the adult population being around 35% to 40% of the prescription. Has this changed?

Yes. Regarding Qelbree, the split of the source of business or the source of patients, so to speak, it's around 32%, 33% it bounces around that are completely naive first-line treatment on Qelbree. And then the remaining 67%, 68% are basically switches or most of them are switches from existing medications. The bulk of that switch typically comes from the stimulant side, products like Vyvanse, Adderall or generics in general. And then the 35% of the switches typically is coming from the other nonstimulants like Strattera, Intuniv and so forth. As far as the combination use, I think it's still around between the 35% and 40% in adult being in combination. It will be interesting to see as the data gets more disseminated and people learn more about some of the data and the new -- and the label of the product and so forth, whether that would change over time. Potentially, it could especially with a lot of the adults who have a lot of comorbidities. But that remains to be seen. But at this point, it's still around that range, yes.

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

Thank you for joining us to learn about our operating performance in the first quarter of 2025. The company has executed well through the loss of exclusivity on 2 of its legacy products. Excluding these legacy products, we continue to deliver robust double-digit growth in revenues. Also, we continue to generate strong cash flows behind the strength of our portfolio, particularly our core products and through the efficiency of our operations. 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, allowing us to continue our investments in our pipeline; Second, the launch of ONAPGO and strengthening our leadership position in Parkinson's. Third, advancing our innovative R&D portfolio of differentiated first-in-class molecules; and finally, continuing our emphasis on corporate development as 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.