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DATE
May 5, 2026
CALL PARTICIPANTS
- President and Chief Executive Officer — Jack A. Khattar
- Chief Financial Officer — Timothy C. Dec
- Managing Director, Investor Relations — Peter Vozzo
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TAKEAWAYS
- Total Revenue -- $207.7 million, a 39% increase year over year, supported by growth product sales and collaboration revenues.
- Commercial Product Revenue -- $178 million, up 26%, driven by higher net sales from key growth brands and new collaboration revenues.
- Onepco Net Sales -- $8.4 million, reflecting a partial quarter benefit from resumed patient initiations starting February and a backlog of approximately 570 patients in process at quarter-end.
- XERZUVEY Collaboration Revenues -- $27.6 million reported in partnership with Biogen, with Biogen recording approximately 100% U.S. sales growth for XERZUVEY versus the previous year.
- Qelbree Net Sales -- $78 million, a 20% increase, with 19% prescription growth outpacing the total ADHD market's 10% growth.
- GOCOVRI Net Sales -- $35.2 million, an increase of 15%, with prescription volume up 7%.
- Cash, Cash Equivalents, and Marketable Securities -- $384 million as of quarter-end, up from $309 million at prior year-end, attributed to operating cash generation and milestone payments.
- R&D and SG&A Expenses -- $164.6 million combined, up from $116.9 million, primarily due to higher spending linked to the Biogen collaboration.
- GAAP Operating Loss -- $8.3 million, narrowed from $10.3 million, due to higher revenue offsetting increased SG&A expenses.
- Non-GAAP Adjusted Operating Earnings -- $28.7 million, compared to $25.9 million last year, excluding amortization of intangibles, share-based compensation, contingent consideration, and depreciation.
- Full-Year 2026 Guidance, Revenue -- Reiterated at $840 million to $870 million in expected total revenue.
- Full-Year 2026 Guidance, Combined R&D and SG&A Expenses -- Reiterated at $620 million to $650 million.
- Full-Year 2026 Guidance, Non-GAAP Operating Earnings -- Anticipated range of $140 million to $170 million.
- Balance Sheet -- No debt, with management emphasizing "significant financial flexibility for potential M&A and other growth opportunities."
- Onepco Prescriptions and Prescribers -- March prescription volume reached 463, surpassing October 2025 levels before supply constraints, and the single-month prescriber count hit its highest mark since launch.
- Qelbree Prescriber Base -- Approximately 43,000 quarterly prescribers, with adult prescribers exceeding pediatric prescribers for the first time.
- XERZUVEY Cumulative Patient Base -- Over 29,000 patients treated since launch, with 85% of prescriptions from routine prescribers.
- SPN-820 (Depression Candidate) -- Ongoing Phase 2b trial in approximately 200 adults with major depressive disorder, evaluating intermittent 2,400 mg dosing alongside baseline antidepressant therapy.
- SPN-817 (Epilepsy Candidate) -- Ongoing Phase 2b double-blind study, targeting roughly 258 patients with treatment-resistant focal seizures at 3 mg and 4 mg twice-daily dosing.
- SPN-443 (ADHD Candidate) -- Planned Phase 1 trial in healthy adult volunteers, scheduled to begin in 2026.
- SUPPLY STRATEGY (Onepco) -- Regulatory submission for a second supplier expected in third quarter, with management guiding for potential FDA approval by mid-2027 and ongoing contingency planning for additional supply sources.
SUMMARY
Supernus Pharmaceuticals (SUPN +0.76%) reported sharply higher total revenue and prescription growth, underpinned by expansion in its CNS portfolio and successful commercial collaborations. Management emphasized stable operating guidance and highlighted its debt-free position, positioning the company for pipeline advancement and business development in the CNS market. Strategic initiatives in supply chain resilience and clinical development signal ongoing investment in long-term growth drivers.
- Quarterly cash holdings rose by $75 million, largely from Shinobi agreement milestones and positive operating cash flow, strengthening liquidity for future acquisitions.
- The company is maintaining capital allocation priorities toward revenue-generating and late-stage CNS assets, with a stated focus on wholly owned opportunities.
- Prescription volume and adult segmentation gains for Qelbree and XERZUVEY reflect a broadening patient and prescriber base, as adult segment growth outpaces pediatric.
- Management confirmed, "If we file, which we expect to do in the third quarter, we expect the approval—consistent with what we said before—could be six to nine months," clarifying expectations for Onepco supply expansion.
- Initiation of new clinical studies for SPN-443 and progress in ongoing trials for SPN-820 and SPN-817 underscore management's continued commitment to pipeline innovation.
INDUSTRY GLOSSARY
- CNS (Central Nervous System): Refers to treatments and diseases related to the brain and spinal cord, including psychiatric and neurological disorders.
- SG&A (Selling, General, and Administrative Expenses): Operating expenses related to selling products and overhead, excluding R&D costs.
- Phase 2b Trial: A later-stage clinical study focused on determining efficacy, dosing, and side effects of a drug in a larger patient group before pivotal trials.
- DTC (Direct-to-Consumer): Marketing strategy directed at patients, commonly through advertising and education campaigns, rather than solely through healthcare providers.
Full Conference Call Transcript
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 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 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 A. Khattar.
Jack A. Khattar: 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 on Onapro. We expect regulatory submission to the FDA in the third quarter of this year with potential approval before midyear 2027. Switching now to Zirzuve, 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, Zarzaur saw strong growth of [inaudible]% in [inaudible] prescriptions and [inaudible]% in 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 ZERZUVEC. Regarding KELLI, 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, Teledy’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 Ikelebri reached a high of approximately 43,000, with adult prescribers for the first time surpassing the number of pediatric prescribers. Switching now to GOCOVRI, 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 mg 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 mg and 4 mg 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 Timothy C. Dec.
Timothy C. Dec: 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 XERJUVEY, 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, CalRit, GOCOVRI, and Anapco, as well as the addition of collaboration revenues from ZERZUDE.
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 $309 million 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 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: 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.
Analyst: Hi. Thanks for the updates, and thanks for taking my questions. Specifically on NAPCO, it is great to see that you have 2,200 start forms now, up from 1,800 in January. Ultimately, what percentage of those start forms do you think 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? Thank you.
Jack A. Khattar: Yeah. 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, an insurance issue, or just lack of response. Sometimes a lot 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. And then, 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 trying to streamline and improve the process. But it is several weeks from when the form is submitted until they finally get the product shipped.
Analyst: Got it. Thank you. And so following up on that, to get to your On APCO guidance at 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. So it looks like you can get there. Can you remind us how many patients are still on Anapco today? And when could you expect most of those hypothetical patients to get on drug? Should it be within the next three to six months then? Thank you.
Jack A. Khattar: You are thinking about it the right way. Yes, that could translate on average to about 700 patients that you need to have throughout the whole year to give you the $70 million in sales. The thing is with the 2,200, remember that is a number that is launch-to-date. That is not 2,200 in 2026, obviously. So it would be interesting to see how many we generate for this year and how many out of whatever is left actually out of the 2,200. 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 machinery, so to speak, in February. It has taken us time, and we were very happy with the progress the team has made through March, really getting us to very high levels, 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, and 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, as I mentioned in my remarks, was really a partial quarter. It was not a full quarter. In the first quarter, we only really benefited from March; February was very partial and very minimal initiation in January. Therefore, it is not a true reflection of a full quarter with the business rebounding. But we are 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, and with the way the team is processing these forms to minimize drop-offs throughout the process.
We feel pretty good, and that is why we did not change the guidance. We feel pretty good about the $45 million to $70 million guidance on that.
Operator: Thank you. Our next question comes from the line of David Amsellem from Piper Sandler. Your line is open.
Analyst: 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 MAP Co and the assumptions to get to the top end of the range and the number of patients. Can you speak to what you are seeing in terms of patient persistence for patients who are getting drug? And then secondly, regarding XERZUVEY, can you speak to how you are thinking about the growth runway of the product? Thank you.
Jack A. Khattar: Regarding Xueve, as I mentioned in my remarks, we are really pleased with the performance of the product. If you look at the fundamental metrics as far as prescriptions and number of prescribers, we are really broadening the prescriber base, and we have been very successful with our partner adviser in doing that. The 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, as we mentioned in previous quarters. The potential of the product is fairly big. Every year, we have around 500,000 women who experience these symptoms.
As I mentioned earlier, only 29,000 patients have been treated with ZERZURA since launch, and we are into year three right now. So we have a long way to go with Zanzuve, and we are very happy with the momentum of the brand. We also started significant efforts on the DTC side and other programs, so we have pretty nice expectations of growth from the product. Regarding OneAPCO and the kind of patient we are getting, it looks like we are starting to get some feel for who that patient is. We do not have a complete full picture yet because, as you would imagine with a new product, it evolves over time.
Some of the early indicators: patients tend to be more on the younger side as far as age and/or earlier in the disease, meaning they have not been diagnosed for a long time. 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 on the Onepo side.
Analyst: Thank you. And then what are you seeing in terms of patient persistence for Panopco?
Jack A. Khattar: It is a little bit too early for us because we had 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 how well titration has happened. With apomorphine, you have to do titration very slowly, starting with lower doses. You cannot jump pretty quickly into high doses on apomorphine.
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 pretty happy and pleased with it. That has been the historical experience in Europe.
Operator: Our next question comes from the line of Kristen Brianne Kluska from Cantor. I apologize.
Kristen Brianne Kluska: It is okay. Hi, everyone. Congrats on a great start to calendar year 2026 here. Just on NOPCO, as we think about the mid-2027 approval, how are you working with your partners out in Europe about 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 constraints are still there to an extent, are you seeing that physicians are prioritizing certain patients over another just knowing that they might not be able to get their hands on enough supply for all of the patients they would want to treat?
Jack A. Khattar: Regarding the last question, we have not detected anything specific that, because of the previous supply chain constraints, they are using the product on a different patient or prioritizing one patient versus another. We cannot really answer that specifically at this point. Overall, regarding your other question on the supplier and 2027 demand, 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 during 2027, we plan to meet the demand of 2027.
We align all that and lay over the current supply and the second supply, 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. The second supplier also, I should say, has multiples of the capacity that the current supplier has. Once the second supplier is online, we will feel pretty good about 2027. I did mention earlier we are even working on another supplier as a backup in addition to the second supplier. We are building a lot of backups from a supply perspective to make sure we meet the demand not only in 2027 but several years beyond.
Kristen Brianne Kluska: Okay. Thanks. And then on XERZUVY, how are you seeing adoption in line with the prescribing? Are you seeing some patients coming back for a second cycle? What percent of patients are completing the 14-day treatment course? I am trying to understand how close to the recommendations you are seeing this in real time. Thanks again.
Jack A. Khattar: The claim is that people stick with the 14-day course therapy. It is a short-term therapy to start with, so it is unlikely that people are going to quit on it, especially when they start seeing the benefit early, pretty quickly by day three. That obviously reinforces and encourages them to finish the 14-day therapy. With Xelube, it is a very different kind of business. You do not have refills unless mom gets pregnant again in another year or cycle and she happens to have PPD a second time with the second pregnancy. Normally, there is no relapse or anything like that for them to come back and cycle through it again.
Operator: Thank you. And our next question comes from the line of Vishwesh Shah from TD Cowen. Your line is now open.
Analyst: Hi. Thank you. Congrats to you guys on another great quarter. On Calibri, what are you seeing in terms of some of the adoption trends right now? You commented on some of the adults trying out Calgary, so is that the shift in focus now, or what do you think will drive growth in adoption through the rest of the year? Thanks.
Jack A. Khattar: We are very excited on Calgary and what we saw in the first quarter. There are several positive dynamics, specifically in the adult segment of the market. Clearly, adult growth has been outpacing pediatric growth for a number of quarters; this is not the first quarter it has happened. We are very pleased that the adult segment continues to grow because it is the biggest segment of the market, and you want to penetrate that segment for continued future growth of the product. For example, if you look at new prescriptions in 2026, adult grew by 27%—this is in new prescriptions, not all prescriptions—and these continue to be strong also with 16% growth.
We have been putting a bit more emphasis on adult, especially when you are out of the back-to-school season. During back-to-school, we rotate resources to pediatrics, but we do not neglect adults. When we are out of the back-to-school season, we try to take advantage of the growth in the adult market. In the total market, adult continues to be the fastest growing segment, so we want to take advantage of that as well. As I mentioned earlier, for the first time now the number of prescribers in adult has surpassed our number of prescribers in pediatrics. It really jumped noticeably in the first quarter, and we were very pleased to see that.
From the patient perspective, what is happening—and we are encouraged about this—is that the patient profile is broadening. We are into year six of the brand, and it is not just early low-hanging fruit anymore. You are getting a much broader set of patient types into the franchise, and physicians are starting to think of many different types of patients and needs where Calvi could be the answer. For example, patients who are intolerant to stimulants. Something interesting emerging is patients looking for all-day coverage. A lot of adults, even if they use controlled-release stimulants, have to supplement at the end of the day with immediate-release stimulant to get full-day coverage. With Calvi, you do not need that.
You take it once a day, whether at night or in the morning, and it will give you full-day coverage. As physicians gain more experience with the product, they are finding more ways to use Caldi as a true solution for many of their patients. Those who are partial responders to stimulants—stimulants work, but not for everybody—are also being considered. Then the complex ADHD patients: as we generate more data around the product and potential use with comorbidities, more physicians are understanding that Calendly could play a role for patients with complex ADHD because of the serotonin modulation and the need for multimodal activity and the pharmacodynamic profile of Calgary.
A lot of very exciting things continue to happen and there is a lot of momentum in the brand.
Analyst: Thanks so much for all the details. And then on NAPCO, what dynamics are you seeing between patients opting for Onabco versus Violet? What kind of competitive dynamics are you seeing there?
Jack A. Khattar: 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. Therefore, they could potentially benefit more from something else—a different mechanism, different molecule—and they would turn to something like Anapco. Conversely, if the physician feels that the patient may still benefit from some levodopa/carbidopa for another year or two, then they might consider Onepo later and choose something else instead of Onako now. From our research, it looks like our patient profile tends to be on the younger, active side, earlier in the disease, versus the Vylev patient who tends to be a little bit older.
We are trying to dig deeper to understand what is behind that. Some folks who have a very difficult time at night may choose Vylev because you put Vylev through the night. With our product, you get similar efficacy on reducing OFF time, but you do not have to wear it 24 hours, whereas with Vylev you have to wear it 24 hours to give you similar efficacy. There are different patient types emerging that could be different candidates for either Onabco or Mylan.
Operator: Thank you. Our next question comes from Annabel Samimy from Stifel. Your line is now open.
Analyst: Hi. This is Jack on for Annabel. Thanks for taking our questions, and congrats on the quarter. On XERZUVEY, I know there is a DTC campaign 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?
Jack A. Khattar: Unfortunately, no, because it is really early to have a good read. We just started it, and you need several months of data to get a meaningful read on response. The only thing I can tell you is anecdotal feedback from physicians and patients who have seen it—they really relate to it. The messages and communication out of the commercial have received very positive feedback. But in the end, it has to turn into prescriptions. That is the key measure. It is pretty early for us right now to say anything as far as the impact of the campaign.
The effort 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. We are building the market, and it takes a while. That is something that needs to continue to be invested in. Initial signals, which are more anecdotal, seem to be positive.
Analyst: Very helpful. And then quickly, given your success with that collaboration, is your current M&A appetite more focused on 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 agnostic?
Jack A. Khattar: Our priority is revenue-generating assets that we can wholly own and build and grow from whatever it is at the time we buy it. The second priority, if it is not revenue generating, is assets that are fairly late stage, so these assets could potentially be launched in one to three years from the time we acquire them. That is what we are very much focused on, and we are fairly agnostic in the CNS space and, of course, women’s health as well.
Operator: Thank you. And our next question comes from Bank of America. Your line is now open.
Analyst: Hey, guys. Thanks for taking our question. I want to follow up on bringing the second supplier online for Onabco. Did you get a chance to meet with the FDA to get any sort of feedback or alignment on the path of getting the approval? Did any of the feedback help inform the cut timeline guidance you have provided today? I am wondering whether there is any accelerated path, like rolling submission relative to your 3Q filing guidance. And on the approval timeline, you guided to by mid-2027; I recall on the last earnings call you talked about a review timeline in the six- to nine-month range.
Do 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.
Jack A. Khattar: Yes, we have been very much in touch with the FDA on an ongoing basis, and the guidance we gave today is based on the discussions we have had with the FDA. If we file, which we expect to do in the third quarter, we expect the approval—consistent with what we said before—could be six to nine months. That would fall at the upper end of the timeline at nine months, which means midyear 2027. If it takes only six months for review, that would obviously be earlier. That is pretty consistent, and the FDA was consistent with their feedback.
Depending on when exactly we file—July, August, September—and then you add six months or nine months, that is within the timeframe we gave today.
Analyst: 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 second more broadly, can you talk about the confidence level of timely clearance of the second supplier?
Jack A. Khattar: We have no indication that something could happen that would derail this timeline from that perspective. Once we submit the package, they have to review the data, and then they have to schedule the inspection. As far as we know, they have been doing inspections outside the U.S. and in Europe. We are not aware of anything that could hinder that. That is why we continue to keep the timeline fluid at six to nine months, specifically because of inspection timing, but we are not aware of anything that would derail this and make it not an option for us. We are pretty confident that we should be able to meet that timeline and secure that second supply.
Operator: Thank you. I am showing no further questions at this time. I would now like to turn it back over to Peter Vozzo.
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 behind 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.
Operator: Thank you for your participation in today’s conference. This does conclude the program. You may now disconnect.
