管理層發言
Good afternoon, and welcome to Supernus Pharmaceuticals, Inc. first quarter 2026 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 is being recorded. I would now like to turn the conference over to Peter Vozzo of ICR Health Care, Investor Relations representative for Supernus Pharmaceuticals, Inc. You may begin.
Thank you. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals, Inc. 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 Pharmaceuticals, Inc. Chief Executive Officer, Jack A. Khattar, and Chief Financial Officer, Timothy C. 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 Pharmaceuticals, Inc.'s current perspective on 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 filing.
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 05/05/2026. 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 Pharmaceuticals, Inc. declines any obligation to update these forward-looking statements except as required by applicable securities laws. I will 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 Pharmaceuticals, Inc.'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 Onepco, during the first quarter, Onepco 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 April 2026. We are also pleased with the progress with the second supplier for Onepco. We expect regulatory submission to the FDA in the third quarter of this year with potential approval before midyear 2027. Switching now to Xerzuvey, Supernus Pharmaceuticals, Inc. reported $27.6 million in collaboration revenues in the first quarter. Full first quarter 2026 U.S. sales of Xerzuvey as reported by Biogen increased approximately 100% compared to the same period in 2025. In 2026, Xerzuvey saw strong growth of 8,273% in prescriptions and number of prescribers respectively compared to the same period last year. Since launch, 85% of the prescriptions have come from routine prescribers and more than 29,000 patients have been treated with Xerzuvey. 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 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 2026 compared to the same period last year. Moving on to R&D, the follow-on Phase 2b 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 milligrams given intermittently twice per week as an adjunctive treatment to the current baseline antidepressant therapy.
Our Phase 2b 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 1 single ascending and multiple ascending dose study in adult healthy volunteers in 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 2026, an increase of 39% compared to the same quarter last year. Total revenues were comprised of revenues from our commercial products including Xerzuvey, 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 Onepco, as well as the addition of collaboration revenues from Xerzuvey. 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 Shinobi.
For 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 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 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 2026 were $28.7 million compared to $25.9 million in the same quarter of last year.
As of 03/31/2026, the company had approximately $384 million in cash, cash equivalents, and marketable securities, compared to the prior quarter as of 12/31/2025. This increase was primarily due to cash generated from operations, the timing of Medicaid payments, and the Shinobi-related commercial milestones. The company's balance sheet remains strong with no debt, providing 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 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?
分析師問答
We will now open the call for questions. Thank you. At this time, we will conduct a question-and-answer session. As a reminder, to ask a question, you will need to press star-1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star-1-1 again. Please stand by. Our first question comes from Andrew Tsai from Jefferies. Your line is now open.
Hi. Thanks for the updates, and thanks for taking my questions. Specifically on Onepco, it is 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 will ultimately be 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.
On average, from the time you get a form until you have a shipment, you could lose somewhere in the 40% to 45% of these patients in the process for all kinds of reasons, whether it is a change in the medical condition of the patient over time, the insurance issue, any of these reasons, or just lack of response. Sometimes many of these forms do not have all the completed information, so you are calling the patient trying to get more information from them to be able to process it. Sometimes they just do not call back. As far as the period of time, it could take several weeks as we go through this process. Of course, we are always looking at different bottlenecks and try to streamline and improve the process.
Got it. Thank you. And so following up on that, to get to your Onepco guidance, the high end of $75 million, mathematically, you are going to be needing more than 700 patients on therapy. So if I did 2,200, 50% conversion, that would be over 1,000 patients potentially on an—so it looks like you can get there. So can you remind us how many patients are still on Onepco today? And when could you expect most of those kind of hypothetical patients to get on drug? Should it be within the next three to six months then? Thank you.
You are thinking about it the right way. Yes. That could translate to somewhere around, on average, about 700 patients that you need to have throughout the whole year to give you the $70 million in sales. The 2,200 number is launch-to-date. That is not 2,200 in 2026. It would be interesting to see how many we generate for this year and how many out of those enrollments translate into paying patients. If we look at the backlog right now, we have 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 are actually improving as time goes on. We are improving our number of patients that are being processed per week. Remember, we just restarted the whole process in February. March we have been very happy with the progress the team has made, really getting us to very high levels. As I mentioned in my remarks, even exceeding performance metrics that were before the supply constraints.
So things are really on the uptick. We are pretty happy with the rebound in the business, how we are processing these forms, how many of these forms we are able to translate into real patients and real shipments. But we maintain the guidance because we would like to see another full quarter. Q1 was really a partial quarter; we really benefited mainly from March. February was very partial and minimal initiation in January. Therefore, it is not a true reflection of a full quarter with the business rebounding. We feel pretty good and that is why we did not change the guidance. We feel pretty good about the $45 to $70 million guidance on that.
Thank you. Our next question comes from the line of David Amsellem from Piper Sandler. Your line is open.
Hi. Yes. This is Alex on for David. Thanks for taking our questions. First one, sort of jumping off of the last question regarding the guidance range for Onepco and the assumptions to get to the top end of the range and the number of patients. Can you maybe speak to what you are seeing in terms of patient persistence for patients who are getting drug? And then secondly, regarding Xerzuvey, can you maybe speak to how you are thinking about the growth runway of the product? Thank you.
Regarding Xerzuvey, we are really pleased with the performance of the product. If you look at the fundamental metrics, prescriptions and number of prescribers, we are broadening the prescriber base, and we have been very successful with our partner in doing that. Prescriptions grew a very healthy 82% in the quarter versus last year. As far as penetration, we are still in the early innings on this product. The potential is fairly big. Every year, we have around 500,000 women who experience these symptoms. Only 29,000 patients have been treated with Xerzuvey since launching, and we are into year three. So we have a long way to go with Xerzuvey, and we are very happy with the momentum of the brand. We have also started significant efforts on the DTC side and other programs, so we have nice expectations of growth from the product. Regarding Onepco, if I understood your question on the kind of patient we are getting on Onepco, it looks like we are starting to get a feel for the patient profile.
We do not have a complete picture yet because, as you would imagine, with a new product it evolves over time. Some early indicators: patients tend to be younger as far as age and earlier in disease course. They tend to be active. From a physician perspective, they are looking for something different than levodopa/carbidopa. That is the kind of patient profile that seems to be emerging right now.
Thank you. And then what are you seeing in terms of patient persistence for Onepco?
It is a little bit too early for us because we got the disruption in the supply. We were pretty happy with the refills and how many patients stayed with us around the time of the supply constraint. We do have dropouts that are fairly consistent with the clinical study, maybe a little bit more. We are watching it very carefully. Typically, these dropouts occur during titration and depend on how well the titration is done. With apomorphine, you have to titrate very slowly and start with lower doses. You cannot jump quickly into high doses. Depending on how that is happening and how the patient is responding, once they go through titration they typically tend to stay with it and be pleased with it. That has been the historical experience in Europe.
Our next question comes from the line of Kristen Kluska from Cantor. Your line is now open.
Hi, everyone. Congrats on a great start to calendar year 2026 here. Just on Onepco, as we think about the mid-2027 approval, how are you working with your partners in Europe about thinking 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 constraints still exist to an extent, are you seeing that physicians are prioritizing certain patients over another knowing that they might not be able to get enough supply for all of the patients they would want to treat?
Regarding physicians prioritizing certain patients because of previous supply issues, we have not detected anything specific that would indicate physicians are treating different patients differently. Regarding the supplier and 2027 demand, we do have a plan with our second supplier and also with the current supplier. Depending on the timing of when the second supplier comes online in 2027, we align current supply and second supply to meet demand. The second supplier has multiples of the capacity of the current supplier. Once the second supplier is online, we will feel much more comfortable about 2027. We are also working on another supplier as a backup in addition to the second supplier. We are building multiple backups from a supply perspective to ensure we meet demand not only in 2027 but several years beyond.
Okay. Thanks. And then on Xerzuvey, how are you seeing adoption in line with prescribing? Are you seeing patients coming back for a second cycle? What percent of patients are completing the 14-day treatment course? What I am trying to allude to is how close to the recommendations are you seeing this in real time?
The 14-day course therapy tends to be completed because it is a short course and patients often see benefit early, by day three, which encourages them to finish the 14-day therapy. Xerzuvey is a different business; you do not have refills unless a patient has a recurrence in a subsequent pregnancy and requires another cycle. Normally, patients do not relapse in that way within the same time frame, so repeat cycles are uncommon unless there is another pregnancy with PPD.
Thank you. And our next question comes from the line of Vishwesh Shah from TD Cowen. Line is now open.
Hi. Thank you. Congrats to you guys on another great quarter. So on Qelbree, what are you seeing in terms of the adoption trends right now? You commented on some of the adults trying out Qelbree. Is that a shift in focus now, or what do you think will drive growth in adoption through the rest of the year? Thanks.
We are excited about Qelbree and what we saw in the first quarter. Adult segment growth has been outpacing pediatric growth for a number of quarters. We are pleased the adult segment continues to grow because it is the biggest segment of the market. If you look at new prescriptions in 2026, adult grew by 27%—this is new prescriptions, not auto prescriptions. We emphasize adult more outside of the back-to-school season because we rotate resources seasonally. When out of back-to-school we push more on adult given the size and growth of that segment. For the first time the number of adult prescribers has surpassed pediatric prescribers. The patient profile is broadening as the brand matures into year six. Physicians are starting to see Qelbree as a solution for many different types of patients. For example, patients intolerant to stimulants, or patients seeking all-day coverage who may otherwise supplement with immediate-release stimulants at the end of the day. With Qelbree you can take once daily and get full-day coverage. Physicians are also using it for partial responders to stimulants and for complex ADHD as we generate more data showing multimodal benefits. So there is a lot of momentum in the brand.
Thanks so much for all the details. And then on Onepco, what dynamics are you seeing between patients opting for Onepco versus Vylev? What kind of competitive dynamics are you seeing there?
The first cutoff often is patients who have been on levodopa/carbidopa and whether the physician sees incremental benefit from switching. Some physicians may keep patients on levodopa/carbidopa for another period before switching to Onepco. Our early data suggests our patient profile tends to be younger and earlier in disease, while Vylev patients tend to be a bit older. Some patients who have significant nighttime issues may choose Vylev because it is worn 24 hours, whereas Onepco provides similar efficacy on reducing OFF time without needing to be worn 24 hours. Different patients may be appropriate for either product.
Thank you. Our next question comes from Annabel Samimy from Stifel. Your line is now open.
Hi. This is Jack on for Annabel. Thanks for taking our questions, and congrats on the quarter. So on Xerzuvey, I know that the DTC campaign is running right now. 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?
It is early to have a read on the DTC campaign. We just started it and need several months of data to get a meaningful read. Anecdotally, feedback from physicians and patients who have seen it has been positive and they relate to the messages. Ultimately it has to turn into prescriptions, which is the key measure. Initial anecdotal signals are positive. The effort is focused on education because this market needs consumer and health care provider education. Building the market takes time and continued investment.
Very helpful. And then given your success with that collaboration, is your current M&A appetite more focused on revenue-generating partnerships or acquisition of wholly owned late-stage assets? Any shifting preferences or are you agnostic?
Our priority is revenue-generating assets that we can wholly own and build. The second priority, if not revenue-generating, is fairly late-stage assets that could potentially be launched within one to three years from acquisition. We are focused on the CNS space and are fairly agnostic within that and also consider women's health opportunities.
Our next question is now open. Please go ahead.
Hey, guys. Thanks for taking our question. I want to follow up on bringing the second supplier online for Onepco. Did you get a chance to meet with the FDA to get any sort of feedback or alignment on the path to approval? Did any of the feedback help inform the guidance you provided today? I am wondering if there is any accelerated path, like rolling submission, relative to your third-quarter filing guidance. Also, on the approval timeline you guided to mid-2027 and previously mentioned a review timeline of six to nine months. Do you have any better clarity on the review timeline now if you have already met with the FDA?
Yes, we have been in touch with the FDA on an ongoing basis, and the guidance we provided reflects our discussions with them. If we file in the third quarter as planned, we expect review could take six to nine months, consistent with what we said before. That implies potential approval around midyear 2027 at the upper end of the range. If review takes six months, approval could be earlier. The FDA has been consistent in feedback across our discussions. The exact timing depends on when we file—July, August, or September—and then you add six to nine months for review.
Great. And my follow-up: the second supplier already has experience applying the product in Europe, but given manufacturing inspection variability, can you talk about the confidence level of timely clearance of the second supplier by the FDA?
We have no indication that anything could derail this timeline from a manufacturing inspection perspective. Once we submit the package, the FDA will review the data and schedule an inspection. As far as we know, the supplier has been subject to inspections outside the U.S. and we are not aware of issues that would hinder the timeline. That is why we keep the timeline at six to nine months; inspections and review scheduling are variables, but we are not aware of anything that would completely derail the option. We are reasonably confident we should be able to meet the timeline and secure that second supply.
I am showing no further questions at this time. I would now like to turn it back over to Peter Vozzo.
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 due to the strength of our growth products and 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.
Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.