Supernus Pharmaceuticals, Inc. ($SUPN)

Let me remind that we're going back to normal, so to speak, initiating new patients back to the right track in launching the product. And March was the first month, of course, full month since we made that change and reinitiation of patients. And we're very pleased with all the metrics in March from prescriptions, number of prescribers, the activity behind the brand across several measures. So in certain cases, actually even higher than before the supply constraints. So we're very pleased with that rebound. And the key is, of course, to continue to work through the backlog that the supply constraint has created because interestingly, the demand continued to be strong despite the supply constraints. Physicians continue to submit patient forms. They realized they -- we were very transparent with everybody about the supply situation. And despite that, they continue to line up patients and put them on the wait list, so to speak, and submit their forms to get on ONAPGO at the right time. So we're very encouraged by that. We got about 500 new forms during the fourth quarter of last year in the thick of the supply constraint and another 400 forms even in Q1 of 2026. So we're very pleased with the demand. And clearly, now we're very focused on processing these as quickly as possible and getting them through the process to create new shipments and new patients on therapy.

Okay. Great. I recall there were, I think, roughly around 570 forms that were in queue. And you mentioned 400 forms that were newly submitted. Maybe can you just walk us through the dynamics here? And typically, as you see on your end, what's the typical turnaround time and success rate for conversion of these forms?

The forms were 400 that were generated in the queue and about that were generated as new forms. And the 570 are the number of patients who are in the queue, they are in the process waiting to get the shipment. So there are two different numbers, obviously. And these numbers are always fluid, and it's always in flux because we always continue to add to the funnel with new forms and then we continue to process some. And also some of them basically drop off because the process is too lengthy or the medical condition of the patient changes over time for a host of reasons. Sometimes some of these don't really translate in the actual patients. But all in all, I mean, the process takes several weeks. Unfortunately, through the process, you have different inefficiencies. I mean, you'll be amazed, sometimes we get the forms and half of them don't have all the information that is required. So you have to go back to the physician's office. You have to go back to the patient. You have to look for the new -- the information that's missing. Without that information, the hub can't really process these forms. And then you have to go through the insurance. I mean, for all kind of reasons, it takes several weeks for a form to actually translate into an actual shipment.

And just to confirm, the 400 new forms and the 570 that are in queue, those are mutually exclusive.

Yes, that's correct.

Okay. So we talked about 970 forms, if I do the math correctly.

That's right.

Okay. Got it. Does Supernus have a dedicated team helping with the processing these enrollment forms?

Yes. I mean we have different teams at different stages of the process. So you have folks who help the physician's office and making sure the forms are completed, follow-up with patients and so forth. Then you have field reimbursement specialists that work hand-in-hand with the hub services to get the insurance process going, making sure all the information is there for the process and for the approval to come in. Then that goes to the pharmacy for shipments. So we have people who follow up with the pharmacy to make sure they ship on time and so forth. And also on the other receiving end, we have the nurses who get notified that a patient is ready to be initiated and therefore, these nurses call up patients at home and they set up an in-home visit. So we do that very high-quality in-home visit with the patient to get them initiated on the drug, train them on how to use the pump, the device, go through the instruction, the titration, which is very important and so forth. And once they're initiated, we follow up with them. So it's not like a onetime visit and that's it. We follow up with phone calls. We even follow up with visits if that is needed. And also some of the nurses as well, they loop back into the physician if there is important medical information that they gain during that process that they believe the physician should know about the patient and what they're going through and so forth. So it's really a full service that we provide our patients to make sure the use of the product is as easy as possible for them.

Just to follow up on the number of new forms, 500 in 4Q, 400 in 1Q. So help us understand, does that reflect a fluctuation in terms of demand on new starts? Or did you guys stop taking new forms because of supply constraint?

Well, you have to factor also Q1. I mean Q1 typically is slower in general, aside from supply issues or on any product, even some of our other products. So Q1 typically is a slower month in general. So that's what you're seeing probably there. Nothing too much I would read into 500 in Q4, but only 400 in Q1. So yes, I mean, it's fairly solid across.

I'm probably barking up the wrong tree here, but given the demographics of these patients tend to be older, do you think maybe 1Q, you're seeing some winter storm across the nation maybe contributing to some of these slower new starts?

I mean there's no question we did have disruption, but I really like to use excuses like this, so to speak, because the demand softens. But I mean, there's always some of that, that happens in winter times. I mean we face that most of the times, yes, absolutely. Because if your rep is out of the field for 2 days out of 5 days, I mean, that's a lot of time for that 1 week out of the month. So yes, I mean, it did impact it.

Okay. Fair. So I think there were 2,200 enrollment forms submitted by 645 prescribers so far since launch. Maybe if I do my math right, 3 to 4 forms per prescriber. So curious, can you talk about opportunity to expand on both the breadth and the depth of prescribing?

Yes. I mean, certainly, we're still in the real early, early times here. I mean we just launched the product a year ago. So clearly, we haven't reached every physician who is a potential prescriber here. Those we have reached, we certainly haven't hit them with the frequency that typically requires behavior -- is required to have behavior change as far as prescriptions are concerned. So there is a long way for us here to continue to build not only on the base, continue to increase the number of prescribers, but we also have a lot of prescribers who are what we say I mean, they're adopting the product, but they're kind of dabblers, so to speak, they dabble with 1 or 2 prescriptions, and therefore, we push pretty hard to get more depth into that practice. Because if you're a physician, I mean, we see obviously your prescription. And if you've been prescribing for 3, 4 months in a row, 1, 2 prescriptions, clearly, you're happy with the product. Otherwise, you'll stop prescribing it. If you are happy with the product on 1 or 2 patients, why wouldn't you expand the use of the product? So we clearly challenge you in a nice way, of course, why wouldn't you put more patients on the product? What is it that's holding you back? And we challenge physicians and make sure they do present ONAPGO as a clear option for a lot of their patients.

Okay. Great. So your current guidance for ONAPGO is $45 million to $70 million. And I assume that taking into some assumption of a range of scenario on both demand and supply side. And one of the questions that have come up during the quarter was let's just take demand out of the equation. How many patients can you supply with the current supplier? Or alternatively can you supply above the guidance?

I mean, clearly, when we came up with this guidance, the $45 million to $70 million, we have several things factored into it, not just demand, not just supply, not just even the resources are required to process the demand because I could have all the supply in the world, but if I can't process these forms and get the insurance process and all that, it doesn't matter how much product I have in the warehouse. So you really need all these factors, and that's what the guidance is built on, not one specific factor. Now simplifying it, if you look at $45 million or $70 million, basically, $70 million means you have to have somewhere around 700, 800 patients all year round on ONAPGO. I mean that's really what translates to about $70 million. And the current supplier who we have, we felt very comfortable. They should be able to meet that kind of demand. Otherwise, our guidance would have been different if we felt supply is going to be a bottleneck or what have you. So we feel very comfortable with the guidance we gave. We didn't change the guidance recently in May in our earnings call. But typically, we like to make any changes if they are warranted. We like to make them more in August time frame because you have a nice 6 months behind you. You really have a very good eye on the trend and what's happening through the year and you have a better -- instead of doing changes early in the year, and then you have to change it back again later on.

Okay. So you've also guided to bringing the second supplier up by mid-2027. So another question that I've got after the quarter was how good of a handle you have on the timing? And what do you see as the biggest unknown in terms of the FDA review process and time line?

Yes. We have actually a pretty good feel for the timing, specifically the submission. So I mean, we know what we need to do. We've produced the batches already. We put them on stability. So now it's just a matter of reading the stability, put the reports together and make the submission. So there is really nothing holding it up from that perspective. And therefore, we feel pretty good about the submission in the third quarter. Now is it July? Is it August? Is it September that I can't predict it to the month or to the week or what have you. And remember, summertime is summertime in Europe. So -- but anyway, so we will be filing in the third quarter, and we have a pretty good feel for that. Now the question is review time. We think the review time is more like 6 months, but sometimes because you have an inspection here that will be required, this is the first time this facility will be sourcing product to the U.S. market, and therefore, the FDA has to inspect the facility. It's in Europe. That we don't have control over, obviously. And that's why we gave a window of 6 to 9 months, so to speak. So if we do file in the third quarter, 6 months review will get you into the end of Q1, and 9 months review will get you into the midyear of 2027. I mean, simplistically that -- but we feel pretty good about the timing, of course, of the submission.

Okay. Great. Another question that's come up after the quarter was when and to what extent you can negotiate with the first supplier or current supplier to improve or increase the capacity, and that's any time before the second supplier becomes online?

Yes. I mean all this has actually been worked out and have been done already before we even announced that we're back on track, meaning we've looked into 2026. We've looked at the capacity of the current supplier and what they can do. We've looked at the second supplier and what is the potential timing bringing them online. So we've looked at all that clearly in the different scenarios or potential outcomes that could happen. And we felt pretty comfortable clearly not just meeting the 2026 supply requirements, but also the 2027. And in 2027, I mean, once we get the second supplier, it doesn't mean I stop getting product from the current supplier. I mean these are not necessarily mutually exclusive. We will have two suppliers, helping us meet the further extra growing demand in 2027. And I did mention occasionally that we also have a third supplier that we're lining up, of course, because we believe the demand will be there for the product, and we will need the capacity. And even without the third supplier, I mean, the second supplier has a much bigger capacity, much larger capacity than the current supplier. So the two suppliers together will be adequate for 2027, no question about it, accounting for growth, of course. And then beyond that, we will have even a third supplier on top of that.

Okay. Great. On the earnings call, you talked about the evolving demographic differences between ONAPGO and Vyalev. And so I'm curious if -- based on this learning, how much you refine your commercial strategy to maximize ONAPGO sales opportunity?

Yes. I mean, big picture, this actually supply-constrained situation, interestingly, if it highlighted something to me, it highlighted one very important aspect, and that is ONAPGO and VYALEV are very different products. And there is a need for both of them, and they can very well coexist together, and there is a different patient for a different product here. And clearly, even during the time when we had the supply constraint, we still generated significant demand. So clearly, these two pumps are not interchangeable. They're not substitutable. They're not -- and physicians view a lot of different patients that need different therapies here. And of course, the main difference is you have a different drug. They're both infusion devices, but clearly, they're very different drugs. And you have patients who may never continue to be able to benefit from levodopa/carbidopa and therefore, a physician might want to give them something else like apomorphine, which is ONAPGO or a physician might feel, now, you know what, a levodopa/carbidopa in a different form may still benefit that patient, so let me try the other infusion device and so forth. And of course, over the years, I mean, you're going to have patients who may try both or who may switch from one versus the other because they are different devices, different drugs. They have different profiles in general, the way they are used, conveniences, AEs, they're all -- it's a different product, obviously. But all in all, I think we are both ourselves and our competitor, we're building a whole new segment here together, a whole new area, which didn't exist about a year ago or 1.5 years ago. And it sounds like the demand is fairly robust for both products, and physicians are really responding pretty well with all kind of patient types and putting a lot of different patients on these infusion devices.

Okay. Okay. Yes. So curious if you have any thoughts about what's the expected duration of therapy for ONAPGO as state. And you have been running some long-term extension studies to evaluate safety and adherence data for ONAPGO such as the infusON trial. So curious, any learnings there? And what's your expectation on typical duration of therapy for ONAPGO?

Yes. What we really have the best things we have is a few studies that actually have been done in Europe because in Europe, the apomorphine infusion device has been available for decades, a couple of decades if not more than that. So there has been several studies following different sets of patients over time. And it varies -- it's all over the place. It's a little bit hard for us to say anything specific on ONAPGO now because it's still early, and we don't have real-time real-world evidence, so to speak. But if you look at these studies, it really varies between as low as 6 months on the product and as long as 6 years or even longer than that. Now clearly, you've got to keep in mind, this is an elderly patient population. So years and years and years, it becomes very difficult after that because a lot of these patients, unfortunately, their medical condition really gets worse over time or they have other complications. But on an average, there are studies that show a median of around 4 to 6 years that people stay on these infusion devices, but it could be as little as 6 months. And if they do go through it at 6 months, it could be because they titrated so quickly, they couldn't tolerate the nausea. From our experience so far, what we're finding out is if you do the titration the right way through the nurse and the training that we provide, actually, a lot of patients don't even feel nausea. But you have to do it patiently, you have to titrate slow and low and you'll be able to tolerate the medication. And if you do tolerate the medication, I mean, we could see how you could stay on the drug for 6 years or whatever if we end up duplicating the European experience.

Okay. That sounds great. One of the questions that's come up was IP runway for the product. Can you talk about the key IP protections, any room for IP extensions and sort of like the complexity of the product, having a device and different components, does it make it harder to genericize?

Yes. We -- what the drug has today, ONAPGO has is drug -- orphan drug designation. The FDA is still reviewing and hasn't ruled yet on the 7-year exclusivity. So we're waiting for that. That's really the protection that we have on the product. Clearly, it's not a simple product, as you pointed out, and everybody knows, we went through several rounds on the regulatory side to get this product. It's a fairly complex drug device combination. So these are not easy products. Now it doesn't mean people will not try. Of course, you give people a lot of time and a lot of money. They can figure out something at some point, right? But that's really the protection that we have with the product. Also, you need a lot of infrastructure around the product and services because the product is not just the product itself. We provide, as I mentioned, a lot of services with it as well.

Great. Maybe the last few minutes, we should talk about Qelbree. Is your nonstimulant drug for ADHD, 6 in the market, double-digit growth still. So can you talk about the opportunity here and the company's strategy for driving sustained growth for the near future?

Yes. Qelbree has been a great success for us. As you mentioned, we are into year 6 already in May, starting year 6 on the market. And we just -- with our earnings call, we reported 27% growth on the adult prescription base, 16% pediatrics. I mean, the growth continues to be very robust. As a reference, I mean, last year, we did 935,000 prescriptions in a market which is 111 million prescriptions a year. So we clearly still have a huge potential for a novel nonstimulant that actually works. We've had nonstimulants in the past, fairly limited number, but we've had them, but they really don't work as well at all. And Qelbree significantly differentiates itself by the fact that it works as early as week 1 for children. For adults, maybe 2 weeks because you may have to titrate a higher dose and you can find out whether it really works for you or not. for adults, which has been a major growth area for us, the market is about 70% of the prescriptions is for adults. In our case, it's only 30%. So we still have way even more room on the growth on the adult side. And there, what we are finding out that a lot of adults are starting to appreciate the fact that Qelbree is an all-day drug. It truly gives you all-day coverage. A lot of adults supplement their controlled release stimulants with immediate release stimulants later in the day because they lose coverage, a lot of XR controlled release stimulants only last 12 hours, 13 hours, 14 hours, maybe. So if you need and you have a longer day, a lot of them supplement with the immediate release stimulant. And many of these adults are finding out that once they start using Qelbree, they don't need anything else to be sure because Qelbree gives you true 24-hour coverage. And therefore, it makes a big difference for them with a product like this. Also in adults, there's a lot of comorbidities, and we've generated very good data in a Phase IV study on the use of Qelbree in ADHD plus anxiety, ADHD plus depression and so forth, and we publish the data and so forth. That is not something on our label. Clearly, we don't promote it, but it's something that physicians have asked for as far as to help me understand how can I use the product in adults. and we generate very strong data in co-administration of Qelbree also with stimulants, and that has been published as well. So we have a tremendous amount of data surrounding the product, which also ties into its mechanism of action, which is a multimodal pharmacodynamic profile, hitting not only on the norepinephrine but also on the serotonin modulation, which is very important in ADHD and more and more data and evidence has been surfacing lately about the serotonin aspect and the treatment in ADHD. So all in all, that has helped us significantly and continue to grow the product, specifically in the adult population.

Maybe last 20 seconds, any thoughts on the orexin role in ADHD? We cover Alkermes following the data. You're going to have some early Phase Ib data later in the year. So curious if you have any thoughts on orexin role in ADHD.

I mean it remains to be seen clearly as far as the -- whether the preclinical models will end up translating into human data. I mean preclinical models tend to be predictive in certain cases in CNS than not. But it will be interesting to see what the first in-human data shows.

Okay. Great. We are out of time. Thanks so much, Jack, for joining us today.

Thank you. Thank you.