Line that we're going back to normal, so to speak, initiating new patients back to, you know, the right track and launching the product. The 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, you know, 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. 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 continued to submit patient forms.
They realized they, we were very transparent with everybody about the supply situation, and despite that, they continued to line up patients and put them on the wait list, so to speak, and submit their forms, to get on APOKYN at the right time. 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. 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, you know, 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, you mentioned 400 forms that were newly submitted. Maybe can you just walk us through the dynamic here? Typically, as you see on your end, what's the typical turnaround time and success rate for conversion of these forms?
Yeah. 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. They're 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. Also some of them basically drop off, you know, because the process is too lengthy or the medical condition of the patient changes over time. You know, for a host of reasons, you know, sometimes some of these don't really translate into actual patients. 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, you know, the information that's missing. Without that information, the hub can't really process these forms. 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.
Just to confirm, the 400 new forms and the 570 that are in queue, those are mutually exclusive?
Yes, that's correct.
Okay, we're talking 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?
Yeah, I mean, we have different teams at different stages of the process. You know, you have folks who help the physician's office in making sure the forms are completed, follow up with patients, you know, and so forth. 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. That goes to the pharmacy for shipments. We have people who follow up with the pharmacy to make sure they ship on time and so forth. 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, you know, and so forth. Once they're initiated, we follow up with them. It's not like a one-time visit and that's it. We follow up with phone calls. We even follow up with visits if that is needed. Also some of the nurses as well, you know, 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.
It's really a full service that we provide our patients to make sure, you know, 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. 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, you know, in general, aside from supply issues or aside I mean, on any product, even some of our other products. Q1 typically is a slower month in general. That's what you're seeing probably there. Nothing too much I would read into, you know, 500 in Q4, but only 400 in Q1. Yeah, I mean, it's fairly solid across.
I'm probably barking the wrong tree here, but given the demographics of these patients tend to be older, do you think you know, maybe Q1 you're seeing some winter storm across the nation may have, you know, may be contributing to some of these slowest 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, you know, the demand softens. I mean, there's always some of that that happens in winter times. I mean, we face that most of the times. Yeah, absolutely. Because if your rep is out of the field for two days out of five days, I mean, that's a lot of time, you know, for that one week out of the month. Yes. I mean, it did impact it. Yeah.
Okay. Fair. I think there were 2,200 enrollment forms submitted by 645 prescribers so far since launch. Maybe if I do my math right, 3-4 forms per prescriber. Curious, can you talk about opportunity to expand on both the breadth and the depth of prescribing?
Yeah, I mean, certainly we're still in the real early times here. I mean, we just launched the product a year ago. 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 a behavior, you know, is required to have behavior change as far as prescriptions are concerned. 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 one or two prescriptions, therefore, we push pretty hard to get more depth into that, you know, practice.
Because if you're a physician, I mean, we see obviously your prescription, and if you've been prescribing for three, four months in a row, one, two prescriptions, clearly you're happy with the product, otherwise you'll stop prescribing it. If you are happy with the product on one or two patients, why wouldn't you expand, you know, the use of the product? We clearly, you know, challenge you in a nice way, of course, you know, why wouldn't you put more patients on the product? What is it that's holding you back up? You know, we challenge physicians and make sure, you know, they do present ONAPGO as a clear option for a lot of their patients.
Okay, great. Your current guidance for ONAPGO is $45 million-$70 million, and I assume that taking to some assumption of a range of scenario on both demand and supply side, and one of the question 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? Alternatively, can you supply above the guidance?
Yeah, I mean, clearly when we came up with this guidance, you know, the $45 million-$70 million, we had several things factor 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, you know, get the insurance process and all that, it doesn't matter how much product I have in the warehouse. You really need all these factors, and that's what the guidance is built on, not one specific, you know, 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. The current supplier who we have, you know, we felt very comfortable. You know, they should be able to meet, you know, that kind of demand. Otherwise, our guidance would have been different if we felt, you know, supply is gonna be a bottleneck or what have you. We feel very comfortable with the guidance we gave. We didn't change the guidance recently in May, in our earnings call. Typically we like to make any changes if they are warranted. We like to make them more in August timeframe because you have a nice six months behind you.
You really have a very good, you know, eye on the trend and what's happening through the year, and you have a better You know, instead of doing changes early in the year and then you have to change it back again later on.
Okay. You've also guided to bringing the second supplier up by mid-2027. 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 timeline?
Yeah. We have actually pretty good feel for the timing, specifically the submission. I mean, we know what we need to do. We've produced the batches already. We've put them on stability. Now it's just a matter of reading the stability, put the reports together, and make the submission. There is really nothing holding it up from that perspective. Therefore, we feel pretty good about the submission in the third quarter. 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. Remember, summertime is summertime in Europe, anyway, we will be filing in the third quarter, and we have pretty good feel for that. The question is review time.
You know, we think the review time is more like six 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 six to nine months, so to speak. If we do file in the third quarter, a 6-month review will get you into the end of Q1. A nine-month review will get you into the mid, you know, mid-year of 2027. We feel pretty good about, you know, the timing, of course, of the submission. Yeah.
Okay, great. Another question that's come up after the quarter. When and to what extent you can negotiate with the first supplier or current supplier to improve or increase the capacity, and that's, you know, any time before the second supplier becomes online?
Yeah, 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. We've looked at all that clearly, and the different scenarios or potential outcomes that could happen. We felt we're pretty comfortable clearly in not just meeting the 2026 supply requirements, but also the 2027. 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.
You know, we will have two suppliers, you know, helping us meet the further extra growing demand in 2027. I did mention occasionally that we'll also have a third supplier that we're lining up, of course, because we believe the demand, you know, will be there for the product, and we will need the capacity. Even without the third supplier, I mean, the second supplier has a much bigger capacity, much larger capacity than the current supplier. The two suppliers together will be adequate for 2027, no question about it, accounting for growth, of course. Then beyond that, we will have even a 3rd supplier on top of that.
Okay, great. On the earnings call, you talk about the evolving demographic differences between ONAPGO and VYALEV. I'm curious if, based on this learning, how much you refine your commercial strategy to maximize ONAPGO's sales opportunity?
Yeah, I mean, big picture, this actually supply constraint situation, interestingly, if it highlighted something to me, it highlighted one very important aspect. That is ONAPGO and VYALEV are very different products. There is a need for both of them. They can very well coexist together. There is a different patient for, you know, different product here. Clearly, even during the time when we had the supply constrained, we still generated significant demand. Clearly, these two pumps are not interchangeable. They're not substitutable. You know, they're not. Physicians review a lot of different patients that need different therapies here. Of course, the main difference is you have a different drug. You know, they're both infusion devices. Clearly, they're very different drugs.
You have patients who may never, you know, continue to be able to benefit from a levodopa carbidopa, and therefore a physician might wanna give them something else like apomorphine, which is ONAPGO. 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. Of course, over the years, you're gonna have patients who may try both or who may switch from one versus the other because they're different devices, different drugs. They have different profiles in general, the way they are used, conveniences, AEs. You know, it's a different product obviously.
All in all, I think we are both, you know, 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 a year and a half ago. It sounds like the demand is fairly robust, you know, for both products. 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. Yeah. Curious if you have any thoughts about what's the expected duration of therapy for ONAPGO at steady state. You have been running some long-term extension studies to evaluate safety and adherence data for ONAPGO, such as the INFUS‑ON trial. Curious any learnings there and what's your expectation typical duration of therapy for ONAPGO?
Yeah, what we really have, the best things we have is few studies that actually have been done in Europe because in Europe, the apomorphine infusion device has been available for decades, you know, a couple decades, if not more than that. There has been several studies following, you know, 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. If you look at these studies, it really varies between as low as six months, you know, on the product and as long as six years or even longer than that.
Clearly, you've gotta keep in mind this is an elderly patient population, so years and years and years, you know, 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. On an average, you know, there are studies that show a median of around, you know, four to six years that people stay on these infusion devices, but it could be as little as six months. If they do go through it at six months, it could be because they titrated so quickly they couldn't tolerate, you know, 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. If you do tolerate the medication, I mean, we could see how you could stay on the drug for six years or whatever if we end up duplicating the European experience.
Okay, that sounds great. One of the question I've come up was IP runway for the product. Can you talk about 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 makes it harder to genericize?
Yeah. We, what the drug has today, ONAPGO has, is orphan drug designation. The FDA is still reviewing and hasn't ruled yet on the seven-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, you know, to get this product. It's a fairly complex drug-device combination. These are not easy products. Now, it doesn't mean people will not try. Of course, you know, you give people a lot of time and a lot of money, they can figure out something at some point, right? That's really the protection that we have, you know, with the product.
You know, you need a lot of infrastructure around, you know, 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.
Yeah.
It's your non-stimulant drug for ADHD, six years in the market, double-digit growth still. Can you talk about the opportunity here and the company strategy for driving sustained growth for the near future?
Yeah. Qelbree has been a great success for us. As you mentioned, we're into year six already in May, starting year six on the market. We just, you know, 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. We clearly still have a huge potential for a novel non-stimulant that actually works. You know, we've had non-stimulants in the past, fairly limited number, but we've had them, but they really don't work as well at all. Qelbree significantly differentiates itself by the fact that it works as early as week one 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%, we still have way even more room on the growth on the adult side. There, what we're 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, you know, or 14 hours maybe.
If you need and you have a longer day, a lot of them supplement with the immediate release stimulant. Many of these adults are finding out that once they start using Qelbree, they don't need anything else to supplement because Qelbree gives you true 24-hour coverage. Therefore, you know, it's makes a big difference for them with a product like this. Also in adults, there's a lot of comorbidities, we've generated, you know, very good data in a phase IV study on the use of Qelbree in ADHD plus anxiety, ADHD plus depression and so forth. We, you know, 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. We generate very strong data in co-administration of Qelbree also with stimulants, and that has been published as well. 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. More and more data and evidence has been surfacing lately about the serotonin aspect and the treatment in ADHD. All in all, that has helped us significantly and continue to grow the product, specifically in the adult population.
Maybe the last 20 seconds, any thoughts on orexin role in ADHD? We cover Alkermes following that data. They're gonna have some early phase I-B data later in the year. Curious if you have any thoughts on orexin role in ADHD.
Yeah, I mean, remains to be seen clearly as far as whether the preclinical models will end up translating into, you know, human data. I mean, preclinical models tend to be predictive in certain cases in CNS than not. It will be interesting to see what their first in human, you know, data shows. Yeah.
Okay, great. We are back on time. Thanks so much, Jack, for joining us today.
Thank you. Thank you.