Supernus Pharmaceuticals, Inc.

Thank you. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals First Quarter 2026 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 www.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, 2026.

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, and thanks, everyone, for taking the time to join us on today's call. Supernus's first quarter results reflect a strong start to the year, including a 56% year-over-year increase in combined revenues of our growth products and an 11% year-over-year increase in adjusted operating earnings.

Starting with ONAPGO. During the first quarter, ONAPGO generated net sales of $8.4 million, reflecting a partial benefit from the resumption of new patient initiations in February 2026.

We are pleased with the rebound in the business since we resumed patient initiations with some of the metrics in March reaching or even exceeding levels achieved before the supply constraints. For instance, prescriptions in March reached 463, exceeding the level reached in October 2025 before the supply constraints.

Also, the number of prescribers in a single month with shipments to patients increased in March to the highest level since the launch of the product. Overall, more than 645 prescribers have submitted approximately 2,200 enrollment forms since the launch of the product through the end of April 26.

We are also pleased with the progress with the second supplier on ONAPGO. We expect regulatory submission to the FDA in the third quarter of this year with potential approval before midyear 2027.

Switching now to ZURZUVAE. Supernus reported $27.6 million in collaboration revenues in the first quarter.

Full first quarter 2026 U.S. sales of ZURZUVAE as reported by Biogen increased approximately 100% compared to the same period in 2025.

In the first quarter of 2026, ZURZUVAE saw strong growth of 82% and 73% in written prescriptions and number of prescribers, respectively, compared to the same period last year. Since launch, 85% of the prescriptions have come from repeat prescribers and more than 29,000 patients have been treated with ZURZUVAE.

Regarding Qelbree in the first quarter and as reported by IQVIA, prescriptions grew by 19% compared to the same period last year, outpacing the 10% growth in the total ADHD market. Net sales of $78 million represented a strong 20% increase over the first quarter last year.

Despite typical first quarter headwinds, Qelbree's growth continues to be solid and is coming from both patient populations with adult prescription growth of 27% and pediatric prescription growth of 15%. In addition, the total quarterly number of prescribers for Qelbree reached a high of approximately 43,000 with adult prescribers for the first time surpassing the number of pediatric prescribers.

Switching now to GOCOVRI. For the first quarter of 2026, net sales reached $35.2 million, increasing by 15% compared to the same quarter in 2025.

Total number of prescriptions grew by 7% in the first quarter of 2026 compared to the same period last year. Moving on to R&D, the follow-on Phase IIb randomized, double-blind, placebo-controlled trial with SPN-820 in approximately 200 adults with major depressive disorder is ongoing.

This study will examine the safety and tolerability of SPN-820 and its efficacy at a dose of 2,400 milligram given intermittently twice per week as an adjunctive treatment to the current baseline antidepressant therapy. Our Phase IIb randomized, double-blind, placebo-controlled study of SPN-817 is also ongoing with a targeted enrollment of approximately 258 adult patients with treatment-resistant focal seizures.

This trial utilizes 3-milligram and 4-milligram twice daily doses. And for SPN-443, our novel stimulant ADHD product candidate, we expect to initiate a Phase I single ascending and multiple ascending dose study in adult healthy volunteers in the second half of 2026.

Finally, corporate development will continue to be a top priority for us as we look for additional strategic opportunities to further strengthen our future growth and leadership position in CNS through revenue-generating products or late-stage pipeline product candidates. With that, I will now turn the call over to Tim.

Thank you, Jack. Good afternoon, everyone.

As I review our first quarter 2026 results, please refer to today's press release and 10-Q that was filed earlier today. We achieved total revenue of $207.7 million for the first quarter of 2026, an increase of 39% compared to the same quarter last year.

Total revenues were comprised of revenues from our commercial products, including ZURZUVAE collaboration revenues and royalty, licensing and other revenues. Revenues from commercial products increased to $178 million, a 26% increase compared to the same quarter last year.

This increase in revenues from commercial products was primarily due to the increase in net sales of our growth products, Qelbree, GOCOVRI and ONAPGO, as well as the addition of collaboration revenues from ZURZUVAE. In addition, revenues from royalty and licensing and other revenues were $29.3 million.

This includes $20 million of licensing revenues related to the achievement of a commercial milestone under the company's collaboration agreement with Shunovi. For the first quarter of 2026, combined R&D and SG&A expenses were $164.6 million as compared to $116.9 million for the same quarter last year.

This increase was primarily due to an increase in SG&A expenses associated with the collaboration agreement with Biogen. Operating loss on a GAAP basis for the first quarter of 2026 was $8.3 million as compared to an operating loss of $10.3 million for the same quarter last year.

The change was primarily due to higher revenues, partially offset by an increase in SG&A expenses associated with the collaboration agreement with Biogen. GAAP net loss was $2.3 million for the first quarter of 2026 or net loss per share of $0.04 compared to GAAP net loss of $11.8 million or $0.21 per diluted share in the same period last year.

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 2026 was $28.7 million compared to $25.9 million in the same quarter of last year. As of March 31, 2026, the company had approximately $384 million in cash, cash equivalents and marketable securities compared to $309 million as of December 31, 2025.

This increase was primarily due to cash generated from operations, the timing of Medicaid payments and the Shunovi-related commercial milestones. The company's balance sheet remains strong with no debt and significant financial flexibility for potential M&A and other growth opportunities.

Now turning to guidance. For full year 2026, the company reiterates its financial guidance for total revenues, combined R&D and SG&A expenses and non-GAAP operating earnings.

As such, we expect total revenues to range from $840 million to $870 million, comprised of commercial product revenues and royalty and licensing revenues. For the full year 2026, we expect combined R&D and SG&A expenses to range from $620 million to $650 million.

Overall, we expect full year operating earnings in the range of $0 to $30 million. And finally, we expect non-GAAP operating earnings to range from $140 million to $170 million.

Please refer to the earnings press release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non-GAAP. With that, I will now turn the call back over to the operator for Q&A.

Operator?

Specifically on ONAPGO, it's great to see that you have 2,200 start forms now, up from 1,800 in January. Ultimately, what percentage of those patients or start forms do you think you will be ultimately converted to a paying patient?

And can you remind us how many weeks it can take from a start form to a paying patient, how long that could take? Thank you.

Yes. On an average, from the time you get a form until you have a shipment, I mean, you could lose somewhere in the 40% to 45% of these patients in the process for all kind of reasons.

Whether it's change in the medical condition of the patient over time, the insurance issue, any of these reasons eventually or just lack of response sometimes because a lot of these forms don't have all the completed information. So, you're calling the patient and trying to get more information from them to be able to process it.

Sometimes you just don't call that. And then as far as the hearing of time, I mean, it could take several weeks.

As we go through this process over time, of course, we're always looking at different bottlenecks and try to streamline and improve the process. But it is several weeks for somebody to have the form submitted until finally they get the product shipped.

And so following up on that, to get to your ONAPGO guidance, the high end of $75 million, mathematically, you're going to be needing more than 700 patients on therapy. So, if I did 2,250% conversion, that would be over 1,000 patients potentially on ONAPGO.

So, it looks like you can get there. So, can you remind us how many patients are still on ONAPGO today?

And when could you expect most of those kinds of hypothetical patients to get on drug? Should it be within the next 3 to 6 months then?

Yes. I mean the high end of our guidance is the $70 million.

You're thinking about it the right way. Yes, I mean, that could translate to somewhere around on an average, about 700 patients that you need to have around 700 patients throughout the whole year, clearly to give you the $70 million in sales.

The thing is with the 2,200, you have to remember, that's a number that is launched to date. That is not 2,200 in 2026, obviously, right?

So, it will be interesting to see how many we generate this year and how many out of the 20 or whatever is left actually out of the 2,200. If we look at the backlog right now, we are probably somewhere around 570, give or take, patients in the queue versus last time we talked it was around 700.

So, we are going through the backlog, and we're actually improving as time goes on. We're improving our number of patients that are being processed per week.

Remember, I mean, we just restarted the whole machinery, so to speak, or the whole process started middle to end of February, so to speak. So it's taken us March, and we've been very happy with the progress the team has made through March, really getting us to very high levels.

As I mentioned in my previous remarks, even exceeding performance metrics, exceeding those that were before the supply constraint. So things are really on the uptick.

We're pretty happy with the rebound in the business, how we're processing these forms, how many of these forms we're able to translate into real patients and real shipments. But we maintained the guidance, of course, because we would like to see another full quarter.

So Q1, as I mentioned in my remarks, was really a partial quarter. It wasn't really a full quarter, right?

So let's see a full quarter and how quickly we can go through this backlog. In the first quarter, we only really benefited from March, so to speak.

February was very partial, very minimal initiations in January. And therefore, it's not a true reflection of a full quarter with the business rebounding.

But we're very happy with how things are moving along across several metrics with the demand continuing to be strong, as you pointed out, with the 2,200 forms, but also with the way the team is processing these forms and try to minimize the drop-offs and the losses throughout the process. But we feel still pretty good, obviously, and that's why we didn't change the guidance.

So still pretty good about the $45 million to $70 million guidance on.

This is Alex on for David. First one, sort of jumping off of the last question regarding the guidance range for ONAPGO and the assumptions to get to the top end of the range and the number of patients.

Can you maybe speak to what you're seeing in terms of patient persistence for patients who are getting drug? And then secondly, regarding ZURZUVAE, can you maybe speak to how you're thinking about the growth runway of the product?

Yes. Regarding ZURZUVAE, as I mentioned in my remarks, I mean, really pleased with the performance of the product.

If you look at the true fundamental metrics as far as prescriptions, number of prescribers, I mean we're really broadening the prescriber base, and we've been very successful with our partner, Biogen, in doing that. And of course, the prescriptions grew a very healthy 82% in the quarter versus last year.

So, as far as penetration, we're still in the real early innings on this product, as we mentioned previous quarters. The potential of the product is fairly big.

Every year, you have around 500,000 women who experience these symptoms. And as I mentioned again earlier, only 29,000 patients have been treated with ZURZUVAE since launching, and we're into year 3 right now.

So, we have a long way to go with ZURZUVAE, and we're very happy with the momentum of the brand. And of course, we also started significant efforts on the DTC side and other programs.

So, we have pretty nice expectations of growth from the product. Regarding, if I understood your question on ONAPGO, is it really the patient profile and the kind of patients we're getting on ONAPGO.

It looks like we're starting to get some feel for who is that patient. We don't have a complete full picture yet because as you would imagine, with a new product, it evolves over time.

But some of the early indicators, patients tend to be more on the younger side as far as age and/or the disease, meaning they haven't been diagnosed for a long, long time. They tend to be active.

They tend to really be looking for -- specifically from a physician perspective, they're looking for something different than a levodopa/carbidopa. So that's the kind of patient profile that seems to be emerging right now as we speak on the ONAPGO side.

And then what are you seeing in terms of patient persistence for ONAPGO?

Yes. It's a little bit too early for us because we got the disruption in the supply and so forth.

And actually, we were pretty happy with the refills and how many patients stayed with us around the time of the supply constraint. So, we do have dropouts that are fairly consistent with the clinical study, maybe a little bit more.

So, we're watching it very carefully. Typically, these dropouts occur when you have the titration and how well the titration has happened, because with apomorphine, you have to do titration very slowly, starting with lower doses, you can jump in pretty quickly into high doses on apomorphine.

So, depending on how that is happening and how the patient is responding to that, once they go through that titration, typically, they tend to stay with it and be pretty happy and pleased with it. And that's been the experience that historically has been in Europe.

Congrats on a great start to the calendar year 2026 here. Just on ONAPGO, as we think about the mid-2027 approval, how are you working with your partners out in Europe thinking about what the demand might look like in 2027 onwards to be able to work with them to meet that criteria?

And then when we think about the U.S. right now in terms of the patients that are getting on therapy, given that these capacity strains are still there to an extent, are you seeing that physicians are prioritizing certain patients over others, just knowing that they might not be able to get their hands on enough supply for all of the patients they want to treat?

Yes. Regarding the last question, I mean, we haven't detected anything specific because of the previous supply constraint that they're using the product on a different patient or one patient versus another.

So we can't clear -- at this point, I can't answer that question specifically. But overall, regarding your other part of the question on the supplier and 2027 demand and so forth, I mean, we do have a plan with our second supplier and also the current supplier, because depending on the timing as to when the second supplier comes in 2027, to meet the demand of 2027, certainly.

And that's really how we align all that and lay over the current supply, the second supply, and look at the demand in total and make sure that we are covered from either one of them, and/or both at the same time. So the second supplier also, I should say, has multiple of the capacity that the current supplier has.

So once the second supplier is online, we will feel pretty good about 2027. And I did mention once earlier, we're even working on another supplier as a backup as well in addition to the second supplier.

So we're giving up a lot of the backups from a supply perspective to make sure we meet the demand, not only in 2027, of course, and several years beyond that.

And then on ZURZUVAE, how are you seeing adoption in line with the prescribing? Meaning like are you seeing some patients who are coming back for a second cycle of it?

What percent of patients are completing the 14-day treatment course? And I guess I'm just -- what I'm trying to allude to is like how close to the recommendations are you seeing this real-time?

Yes. ZURZUVAE typically, I mean, the people stick with the 14-day therapy.

It is a short-term therapy to start with. So, it's unlikely that people are going to quit on it.

So -- and especially when they start seeing the benefit early, pretty quickly by day 3. So that obviously even reinforces it and encourages them to finish the 14-day therapy.

And with ZURZUVAE, obviously, it's a very different kind of business. You don't have refills.

Of course, unless mom gets pregnant again, and it's another year or cycle, so to speak, and she happens to have also PPDs with the second pregnancy. But normally, there is no relapse or anything like that for them to come back and cycle fluid again.

Congrats to you guys on another great quarter. So on Qelbree, what are you seeing in terms of some of the adoption trends right now?

You commented on some of the adults trying out Qelbree. And so is that the shift in focus now?

Or what do you think will drive growth in adoption through the rest of the year?

Yes. We're actually very excited on Qelbree and what we really saw in the first quarter, and it's a pretty interesting dynamic in a very positive way, specifically in the adult segment of the market.

So, there are several things that I would pretty much emphasize on Qelbree. Clearly, the adult growth has now outpaced pediatric growth for a number of quarters, actually.

This is not the first quarter it happens. We're very pleased with the fact that the adult continues to grow because it is the biggest segment of the market, naturally, and you want to penetrate that segment as much as possible and be very successful in it for the continued future growth of the product.

And for example, I'll give you another metric. If you look at new prescriptions in the first quarter of 2026, adults again grew by 27%.

This is in new prescriptions, not total prescriptions. And these continue to be strong, also with 16% growth.

So, the interesting thing is, I mean, we have been emphasizing adult. We've been putting a little bit more emphasis on adults, especially when we are out of the back-to-school season, because we rotate, of course, the emphasis, and we rotate the resources in the back-to-school season.

Clearly, we put more of a push on pediatrics, but we don't neglect adults. And then when we are out of the back-to-school season, we try to take advantage of the growth in the adult market because from a market point of view, in the total market, adult also continues to be the fastest segment that is growing.

So, we want to take advantage of that as well. So we're pretty pleased with that.

And as I mentioned earlier, this is for the first time now, a number of prescribers in the adult population has surpassed our number of prescribers in pediatrics, and really jumped pretty quickly, noticeably in this first quarter. So, we were very pleased to see that.

Also, from the patient perspective, what's really happening, which we're encouraged about also, is the fact that the patient profile, and you would expect that typically in the brand, as it stays in the market for a while, and now we're into year 6, pretty much in May, we're in year 6 of the brand. The patient profile is broadening.

So, it's not anymore some of the early low-hanging fruit that you're getting basically. What I mean by that is you're really getting a much broader type of patients into the franchise, and physicians are starting to think of so many different types of patients and needs out there that Qelbree could be the answer for.

For example, patients who, of course, are intolerant to stimulants, something interesting emerging is patients are really looking for all-day coverage. And a lot of the adults, we know it as a fact, when they use stimulants, even if they use controlled-release stimulants, so many of them have to supplement at the end of the day with an immediate-release stimulant to give them that full day coverage.

But with Qelbree, you don't need any of that. You just need to take it once a day, whether at night or in the morning, and it will give you full-day coverage.

So, I think physicians, over time, as they have more experience with the product, are finding more ways to use Qelbree as a true solution for a lot of their patients. And then, of course, those who are partial responders to stimulants, I mean, stimulants work, but they don't work for everybody.

And sometimes we forget that. And a lot of physicians are using it for those partial responders to stimulants.

And then the complex ADHD. And of course, that comes with time as we generate more data around the product and the potential use of the product with comorbidities and so forth, more and more patients are starting to understand that Qelbree could really play a role with these patients who have that what we call complex ADHD because of the serotonin modulation and the very unique multimodal activity and pharmacodynamic profile of Qelbree.

So, a lot of very exciting things continue to happen there and really a lot of momentum in the brand.

And then on ONAPGO, what dynamics are you seeing between patients opting for ONAPGO versus VYALEV? So, what kind of competitive dynamics are you seeing there?

Yes. I mean I mentioned very quickly, I mean, the first cutoff typically is patients who have been on levodopa/carbidopa and the physician may not see any incremental additional benefit for the patient to stay on that drug.

And therefore, they could potentially benefit more from something else, a different drug, different mechanism, different molecule, and therefore, they would go and turn to something like ONAPGO. And vice versa, if the physician feels that the patient may still benefit from some levodopa/carbidopa maybe for another year or 2 and then they might consider ONAPGO, so they might go towards something like VYALEV or something else instead of ONAPGO.

So that's the first type of thing that obviously a physician is assessing. And then interesting from our research, it looks like our patient profile tends to be on the younger side, the active side earlier in the disease versus the VYALEV patient tends to be a little bit more on the older side.

We're trying to dig into deeper into this to really understand what's behind some of that. Some of the folks who may need and have very difficult time at night, they may choose VYALEV because you have to put VYALEV through the night.

With our product, I mean, you get pretty much a similar efficacy on reducing off time, but you don't have to wear it 24 hours. But with VYALEV, you have to wear it 24 hours to give you pretty much similar type of efficacy.

So, there are different patients that are emerging that could be really different candidates for either ONAPGO or VYALEV.

This is Jack on for Annabel. Congrats on the quarter.

So, on ZURZUVAE, I know that there the active DTC campaign running right now. Clearly, the product has been doing very well overall.

But do you have any additional insights or color on feedback from that and how patients are responding to the DTC campaign compared to maybe a more direct physician recommendation?

Yes. Unfortunately, no, because it's really early to be able to have a good read.

I mean we just started it, and you need several months of data to get a meaningful read on a response if you're getting a good response from the DTC. The only thing I can tell you is kind of anecdotal feedback from physicians, from patients who have seen it or I mean they really relate to it.

The messages, the communication out of the commercial and so forth, we've received very positive feedback on that. But in the end, it has to turn into prescriptions, of course.

I mean that's really the key measure at the end of the day. And it's pretty early for us right now to say anything as far as the impact of the campaign.

But certainly, I mean we -- I mean the effort there is clearly to provide significant education because this is a market that needs a lot of education on the consumer side as well as on the health care provider side. And that's what we are trying to do.

We've been building the market, and it takes a while to build the market, and that's something that needs to be -- continue to be invested in. But again, initial signals, which are more anecdotal seems to be positive.

Very helpful. And then just quickly, given your success with that collaboration, is your current M&A appetite kind of more focused on maybe something similar, like a revenue-generating partnership or more on acquisition of wholly-owned late-stage assets?

Are there any shifting preferences there? Or are you still kind of agnostic to any option?

Yes. No, I mean our priority is revenue-generating assets that we can wholly own it and obviously build it and grow it from wherever it is at the time we buy it.

And then the second priority, if it's not revenue generating, we're looking at assets that are fairly late stage. So, these assets could potentially be launched in like between a year to 3 years from the time we acquired them.

So that's really what we're very much focused on and fairly agnostic in the CNS space and of course, women's health as well.

I want to follow up on the bringing the second supplier online for ONAPGO. Could you give a chance to meet with the FDA to get any sort of feedback or alignment on sort of the path of getting the approval?

Did any of the feedback help inform the timeline guidance you provided today? What I'm wondering is whether there's any accelerated path like rolling submission relative to your 3Q filing guidance?

And I guess on the other side of the things, on approval timeline you guided to by mid-2027. I recall on the last earnings call, you talked about review timeline could be a range somewhere in the 6- to 9-month range.

So, I'm curious if you have any better clarity on the review timeline now if you have already met with the FDA? And I have a follow-up after that.

Yes, sure. Yes, the answer is yes.

We've been very much in touch with the FDA on an ongoing basis. And yes, the guidance we just gave today has been and is based on the conversations we've had with the FDA.

So if we do file, which we said we're expecting to file in the third quarter, we expect the approval, again, consistent with what we said before, it could be 6 months to 9 months. So that will fall at the -- at the upper end of the timeline, 9 months, that means midyear 2027.

And if it does take only 6 months for review, that obviously will be within that -- earlier than that. So that's pretty consistent.

The FDA was consistent with their feedback with all the discussions we've had with them. So depending on when exactly we file, July, August, September, whatever, and then you add 6 months to it or it could take 9 months, I mean that's really within that frame that we just gave today.

Great. And my follow-up is, obviously, the second supplier already has experience supplying the product in Europe.

But given the sometimes-idiosyncratic nature of the agency handing out manufacturing issue citations and the sector more broadly, can you talk about the confidence level of timely clearance of the second supplier?

I mean we have no indication that something could happen that -- that could really derail this timeline from that perspective. I mean, clearly, they have -- once we submit the package, they have to, of course, review the data and so forth.

And then they have to also schedule the inspection. And as far as we know, I mean, they have been doing inspections, although it is outside the U.S.

and Europe. So, we don't see -- and we're not aware of anything that could hinder that.

But that's why we continue to keep the timeline fluid saying 6 to 9 months because of that specifically, but we're not aware of anything that could tell us that this could derail this thing completely and make it not an option for us at all. So, we're pretty confident that we should be able to meet that timeline and secure that second supply.

Thank you for joining us on this call today. 2026 is off to a great start.

We have positive momentum across our business, and we continue to generate strong cash flows beyond the strength of our growth products and through the efficiency of our operations. We look forward to continued strong growth and execution on our growth products throughout the year.

Thanks again for joining us this afternoon. We look forward to providing you with updates throughout the year.