Good afternoon, and welcome to Supernus Pharmaceuticals Third Quarter 2023 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, Stephen. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' third quarter 2023 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, the 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 November 08, 2023. 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 as we discuss our 2023 third quarter results. Supernus continues to execute well during a transition year with the loss of exclusivity on its flagship brand, Trokendi XR.

Our third quarter performance underscores our strong execution with combined net sales of $70 million for our growth products, Qelbree and GOCOVRI, representing an increase of 52% in the third quarter of 2023 compared to the same period last year.

This $70 million in net sales from Qelbree and GOCOVRI far exceeded the $49 million decline in Trokendi XR net sales in the third quarter compared to the same period last year.

Similarly, for the first nine months of 2023, combined net sales of Qelbree and GOCOVRI grew by 61%, reaching $182 million, far exceeding the $129 million decline in net sales of Trokendi XR during the same period. In addition, and excluding Trokendi XR, total year-to-date 2023 revenues for Supernus grew by 25% compared to the same period last year.

Moving on to the ADHD market, this year's back-to-school season showed a decline of 3% in total U.S. ADHD prescriptions in the month of September 2023, when the new school year is mostly in full swing across the U.S., as compared to the month of June 2023, when the prior school year mainly ends.

This contrasts with the 4% to 10% growth in the previous four years over the same time period. While the overall ADHD market had a soft back-to-school season, Qelbree delivered robust prescription growth of 16.6% in September 2023 compared to June 2023.

In addition, Qelbree accelerated its quarterly sequential prescription growth in the third quarter 2023 to 12% up from the 9% sequential growth in the second quarter of this year. During the third quarter of 2023, the average net price per prescription for Qelbree was $227, an increase of 7% compared to the second quarter of 2023.

This increase was primarily due to an improvement in gross to net, which was around 58.7%, the lowest since the launch of the product, and a key step towards our year-end target of 50% to 55%.

As a result, Qelbree net sales in the third quarter grew by 20% and 100% compared to the second quarter of this year and the third quarter of last year, respectively. Finally, during the third quarter, Qelbree expanded its base of prescribers to approximately 24,189, up from 21,291 prescribers from the second quarter of 2023.

Switching now to GOCOVRI, net sales increased to $33 million in the third quarter of 2023, representing a healthy increase of 18% over the same period in 2022 and 14% over the second quarter of this year. We continue to be pleased with the performance of the brand, which is now at an annualized run rate of approximately $130 million in net sales.

Regarding Oxtellar XR, third quarter net sales were $30 million, essentially stable compared to net sales in the same period last year. For Trokendi XR, net sales in the third quarter were $21 million, up slightly from $19 million in the second quarter and down from $70 million in the third quarter of last year.

Given the performance of Trokendi XR in the first nine months of this year, we are revising our financial guidance and now expect approximately $90 million in net sales for full year 2023. Regarding SPN-830, earlier this month, the FDA accepted the resubmission of the NDA and assigned to it a PDUFA date of April 5, 2024.

A few weeks ago, we held an R&D Day and shared an overview of our emerging CNS pipeline of novel product candidates. We highlighted an exciting pipeline of new chemical entities, some of which are first-in-class mechanisms of action to treat multiple therapeutic areas in CNS. The company has a significant number of near-term milestones.

First, the initiation of a Phase IV study with Qelbree in ADHD patients with comorbid mood disorders, such as depression and anxiety, before year-end 2023. Second, the initiation of a Phase II open-label study with SPN-820 in approximately 40 subjects with major depressive disorder, also before year-end 2023.

Third, getting top-line data in the first half of 2024 from the Phase IIa study of SPN-817 for treatment-resistant focal seizures. Fourth, the initiation of a Phase IIb placebo-controlled study with SPN-817 in patients with treatment-resistant focal seizures, also in the first half of 2024.

And fifth, the potential launch in the second half of 2024 of SPN-830 for the continuous treatment of motor fluctuations in Parkinson's disease, if approved by the FDA. 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..

for total revenue, we are narrowing the range to $590 million to $610 million, compared to our prior guidance of $580 million to $620 million; for the full year 2023, we expect combined R&D and SG&A expenses to range from $420 million to $440 million, down from our prior guidance of $450 million to $480 million.

Overall, we expect 2023 GAAP operating loss to range from $5 million to $15 million, an improvement from the previous guidance range of an operating loss of $10 million to $30 million.

We are also increasing our GAAP operating earnings – non-GAAP, excuse me, operating earnings for the full year 2023 and now expect a range of $95 million to $110 million compared to a range of $75 million to $100 million previously.

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

Operator?.

Thank you. At this time, we will conduct a question-and-answer session. [Operator Instructions] First question comes from the line of Andrew Tsai of Jefferies. Your line is now open..

Okay. Good afternoon. Thanks for taking my questions. I thought I would start this quarter by asking on pipeline questions after your R&D Day.

So, maybe for the first one, for your full epilepsy data set later in the first half of 2024, remind us again what would be meaningful data to you on efficacy in terms of seizure reductions and seizure freedom rates, understanding this is an open-label study.

And then secondly, for SPN-820, your depression asset that you are evaluating the pulsatile action of this dosed every three days in 40 patients, data, I believe, also, first half of 2024. So, what kind of MADRS AMD, separation do you also want to see? What's positive data to you and why? Thank you..

Yes, I'll take this. So, starting with SPN-817, as we did share, as we mentioned, in the R&D Day, the interim data, the first look at the data we have from the, I think, it was six or seven patients, looks really promising.

And the profile that is emerging on this product so far is showing seizure reduction in the 60% or even up to 80% in certain situations. So, that is extremely promising, yet it is early, obviously, it is early in a small set of number of patients.

So, what we hope to see, obviously, is consistent data with that trend, with that emerging data that we've seen early on, that the full study will show very, very similar type of ranges in seizure reduction, because that will clearly differentiate the product versus other products on the marketplace.

Seizure freedom, I mean, so far, it's very small numbers, so, whatever we have, we have, one patient that we talked about, I guess, from the study in Australia, which had three patients, and we still have one left on that study, and he has been seizure-free, I think, for three years or more.

Again, very small numbers early on, but very promising and very encouraging, certainly. So, we sure hope that the study eventually will be very consistent with all these trends that we've seen so far.

On SPN-820, the second study that we are starting before year end, which is the pulsatile dosing, as well the other important one is in also the major depressive disorder, an MDD instead of TRD. So, we want to explore that expanded type of potential use for the product, so it's not only for TRD.

Clearly, we are looking for meaningful reductions that could be seen on the endpoints. We are looking at so many secondary endpoints in that study as well, as we are in the Phase IIb study that is currently going on with TRD.

So, both studies will clearly inform us tremendously in looking forward in how to design the Phase III, whether the pulsatile dosing will be better than the once-a-day dosing and so forth.

So, we're trying to explore as many different aspects of the study of the molecule as possible to give us better information as we start working on the design of the Phase III program..

Got it. And one more is just for the Phase IIb ongoing with data 2025, a target of 268 subjects. A month ago, I think, you had 87 patients in the screening phase or later.

So, where would you want to be on that number in let's just say, three to six months, and how are you ensuring you get there on time?.

Yes, I mean, we are hoping we can really complete the enrollment in a significant way in the second half of 2024, and that's why we're saying top-line data in 2025. Clearly, we are working very hard to make it as early as possible in 2025.

It's a little bit hard for us to guess right now because enrollment, a lot of times you would have, like, a couple weeks of very good, strong enrollment, and it softens a little bit, and it picks up again. So, it's not always a linear trend from a recruitment perspective, enrollment perspective.

We are also – and we continue to make different revisions to the protocol. Remember, this is a first-in-class molecule, mechanism of action. There is so much that we don't know about this class of drugs, clearly. So it's not like somebody has been before us.

So, we've been very cautious from the beginning in designing the study, the different protocols we've had.

We've had now three amendments to the protocol, and in every amendment we incorporate some of the learnings we have from the study in facilitating recruitment by either relaxing inclusion criteria and exclusion criteria, and making adjustments there.

So, all this to say basically that the recruitment hasn't been always very predictable in a linear fashion, but we are certainly looking at hopefully fully enroll the study in a meaningful way by the second half of 2024 and therefore get data, I mean, as early as we can in 2025.

As we get closer in time or as time goes on, we'll certainly update investors and be a little bit more specific as to when in 2025..

Very good. Thank you very much..

Sure..

Thank you. One moment for our next question. The next question comes from the line of David Amsellem of Piper Sandler. Your line is now open..

Hi. Thanks. This is Skylar [ph] on for David.

First, looking at the script data for Qelbree how does the acceleration in volumes for back-to-school season look versus your expectations? Can you speak to any dynamics regarding back-to-school that you think will be impactful in the fourth quarter? And then second, can you speak to the adult and pediatric patient mix for Qelbree? How is adoption in the adult ADHD setting impacting or will it impact the average value of any given prescription? Thanks..

Yes, regarding the back-to-school season, as I mentioned in the prepared remarks, this year it is softer and it was softer than previous years. We actually saw significant acceleration in the back-to-school growth around COVID time, continued a little bit for a couple of years and then started trending down.

And this year was the lowest point, which I mentioned was a minus three actually growth, a decline of 3%, which is the first time we see in several years looking back at the ADHD market in total. Now, even despite that, Qelbree actually grew by 16.6%.

And the way we are measuring back-to-school season, just to clarify here, we're looking at the September month, that's when really the school is in full swing, everybody is already in school. And we are looking at June, which typically when everybody is out of school.

So that's why you pick these two months as a surrogate measure, so to speak, for back-to-school season. And these were the numbers that I referred to. This past season there was a decline of 3%, September from June, Qelbree actually grew 16.6%. So we clearly did extremely, well and much better than the market itself.

Can we do better? We always look for doing better clearly, I mean, overall. As far as the recent weeks, we have seen a little bit stronger weekly data. If you look at the fourth quarter sequential data versus the third quarter, I mean, so far we are trending more in the 20%, 24%.

So, clearly a little bit healthier than the third quarter, but it remains to be seen how the full quarter ends up trending. Regarding your next question on the mix, adult is about 28% to 30% of the business. So, it's been stable, which you would expect because the third quarter was a major push for us on the pediatrics.

So, although adult is still in the launch mode, during the third quarter we clearly put a lot of effort and prioritization behind the pediatric business because of the back-to-school season.

So as time goes on, we do expect adult to continue to grow, however, we don't think it will mirror exactly like the market, which is 70% or 67% adult and 30% pediatric. I don't think we will get to that level, but it may settle on an ongoing in the future, maybe a fifty-fifty. Hopefully, that will be great if we get to that kind of mix..

Great, thank you..

All right, thank you. I am showing no further questions at this time. I would now like to turn it back to Jack Khattar for closing remarks..

Thank you. In concluding our call this afternoon, our growth products, Qelbree and GOCOVRI, delivered strong growth of 61% in net sales in the first nine months of this year and far exceeded the loss of Trokendi XR net sales.

We will continue to focus on making the 2023 transition as smooth as possible as we move away from the legacy products and set the stage for continued growth in 2024 and beyond. We are well positioned for continued growth with three key areas.

First, the existing portfolio that we have today with Qelbree and GOCOVRI, driving significant growth and together with the rest of the portfolio, generating strong cash flow, allowing us to invest in our pipeline. Second, an innovative R&D pipeline of differentiated first-in-class molecules.

And finally, continued execution on the corporate development side to augment our growth through external growth opportunities. Thanks for joining us this afternoon. We look forward to updating you on our next call..

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