Supernus Pharmaceuticals, Inc.

Q1 2023 Earnings Conference Call

5/9/2023

spk00: including Tricendi, which you've guided to, Oxceller and so forth. Would you agree that Calgary sales could maybe more than double, if not almost triple this year? And if that's the case, I know you're not trying to provide guidance, but directionally speaking, if that's the case, then is it fair to assume Calgary sales should accelerate on a quarterly basis going forward? That's just the root of my question. Thank you.
spk04: Yeah, the short answer is yes. I mean, we do expect Calgary to accelerate as the year goes on, and especially, of course, as we also get closer to the back-to-school season on top of all that. Yes, it is more than double than last year. That's an easy answer, actually, given last year's performance. And We've made several comments this quarter and even the last quarter, obviously, about the different dynamics in the marketplace that are helping us and are expected to continue to fuel the growth behind the brand. From the market itself being a very healthy market, the ADHD market, then clearly, from a managed care perspective, continued improvement on the coverage, the continued increase in the WACC, average, you know, wholesale acquisition cost, and of course, the expansion in our sales force and so forth, and the improved coverage from an ADHD market perspective. So all these are pointing and aligned in one direction, which is really continue to push Calvary and increase the momentum and the growth behind the product. Thank you, Jack.
spk02: Okay. One moment for our next question. Next question comes from David Ansellum of Piper Sandler. Your line is now open.
spk03: Hey, thanks. So on Calgary, can you talk about, Jack, where you see the mix between adults and PEDs evolving over time? And I may have missed on your prepared remarks what you said on the current mix between adults and PEDs, but just talk about where you think that mix is going to go. over time? Secondly, can you provide more specifics on, you know, where you need to improve upon in terms of managed care access? And then third, just real quick on Oxfeller, I believe you have a generic filing, a trial on a generic filing pending. So just wanted to get your thoughts on that and the relative risk of potentially an earlier than expected loss of exclusivity on XSeller. Thank you.
spk04: Yeah, sure. On the first question for Calgary and the mix of the business, I mean, where we are right now, we are about, you know, somewhere between 28%, 30% adult and the rest being pediatric. Um, the market itself, if you remember, it's, it's, you know, basically almost the other way around, uh, where the bulk of it is adult around 67% and pediatric around 33%. So clearly as time goes on, we continue to expect, you know, to grow our business in the adult market. And will it eventually mimic exactly the market? Uh, we don't know for sure. Obviously we're still early in the adult launch, uh, Certainly, we've done extremely well, and we're very happy with the adult launch. And also, right now, looking at the mix right now versus looking at it in the fall with the back-to-school season, the mix may flip a little bit because you have a little bit more momentum behind the pediatric business in the back-to-school season. So these ratios are going to shift over time and continue to shift. But at some point, we will find ourselves probably closer to the market but may not mimic it exactly. Regarding the next question on the managed care improvement, that is always an ongoing process. We will continue our discussions with other PBMs and continue to add contracts where it makes sense and where it is reasonable for us to enter these contracts. Same thing with the Medicaid and the different states. It's an ongoing process where we always look for improving our position over time. And clearly, as time goes on, as utilization goes up, as we continue to be successful as we've been in the last couple of years, improving and growing the prescriptions in a really solid way, that even gives us further ammunition to go back and renegotiate contracts or try to improve our position as time goes on. Regarding Oxtelor XR and the generic situation, we basically have three generic companies where we are, you know, we have sued these three generic entrants that wanted to come in on Oxfeller XR. We are in the middle of litigations. I can't really comment one way or the other, but there is certainly a risk on Oxfeller XR that we may be able to maintain exclusivity until the end of the patent expiration, which is 2027, or we may not. So we really don't know. We will certainly update the street on how things progress or don't progress or whether any settlements occur, if they do occur. So certainly at this moment, there is nothing really I can report, but we will definitely report or announce anything if anything comes up. But certainly there is a risk for us on Oxtelrexor as time goes on. And I don't know if I missed, was there a question on Trocandy?
spk03: No, that's it. Just on Oxteller. If I may just follow up real quick. I believe you had prior litigation that you did win, if I'm not mistaken. Just a quick refresher on that.
spk04: Yeah, sure. The first two generics that filed on Oxteller XR, TWI and Octavis, which is now Teva, we actually went to court on these two cases and we won in both cases all the way through appeal. So that is correct. That was back in the 2016-17 timeframe when those cases were resolved, actually, in our favor. So this is a second wave of generics that have filed in the last two to three years, and we are in litigation with the second wave of the generics.
spk03: Okay. That's helpful. Thank you, Jack.
spk04: Sure.
spk02: Okay. Thank you for the question. Again, as a reminder, to ask a question, you will need to press star 1 1 on your telephone. Our next question comes from Annabelle Samimi of Stifle. Your line is now open.
spk01: Hi, this is Jack on for Annabelle. Thanks for taking our questions. Could you talk a little bit about the GoCov relaunch and how that's going relative to your expectations? You seem to have a pretty refined message that you can treat both the off episodes and the dyskinesia. Are physicians receptive to that, or do they only want to talk about how to maximize treatment of the off periods? Is there any friction there?
spk04: Yeah, sure. Yeah, I mean, we've been very pleased with the recovery and the response we've been getting from the market from physicians regarding the unique positioning of the product, its unique profile, which is it's the only product in Parkinson's that is approved to treat dyskinesia and off episodes. And obviously, you know, this quarter also was fairly solid, you know, given, again, it's a first quarter, which typically we have the headwinds of insurance and everything else that goes on in our business in the first quarter. We're very happy with recovery, you know, delivering 15%, you know, growth versus last year. And that's on top of the 19% growth that it delivered last year. And as far as the message itself and the positioning, it really depends on... the physician, their practice, how they treat Parkinson's. Are they actually movement disorder specialists or are they general neurologists? So the discussion in the physician's office sometimes is a little bit different depending on the specialty. But overall, you know, there is a lot of education that has to occur and that we continue to do that from a market education perspective, really helping physicians discuss the real issues, bring up the issue of dyskinesia. Patients sometimes on their own, they're not aware that actually dyskinesia, you know, is caused by a lot of the medications they're on. They might think, you know, actually dyskinesia is part of the disease, and therefore they don't raise it. They don't talk about it. They don't ask physicians about it. Physicians don't, you know, ask the patients about it. So we try to improve the education in the marketplace to make sure that is brought up in the conversation between the patient and the physician, so that people can be aware of the fact that it is an issue. It can be dealt with. There is a product that actually treats it, and not only treat dyskinesia, but also treat the off episode. And there is really no need to have a trade-off here between the efficacy of a lot of these Parkinson's agents, specifically levodopa, carbidopa, what we're talking about here. There is really no need for the physician to taper off or reduce the dose of levodopa carbidopa to get rid of dyskinesia, you can always add gocovery, treat the dyskinesia, but even also get efficacy on the off episodes at the same time. It's a beautiful solution that people, if they really understand the situation, they can have great results with gocovery. It's just a matter of continued education, continue to push that unique positioning that Gokabri holds in the market. And I think so far, you know, the results speak for themselves as far as the uniqueness of the product and its continued benefit in the marketplace.
spk01: Got it. And then if I could just ask one more on Calabria. do you have a granular breakdown of where those prescriptions are coming from in terms of naive patients versus switches from stimulants or non-stimulants? And now with the increasing volumes that you're getting, are payers becoming more permissive with prescribing, or are they still requiring step edits?
spk04: Yeah, regarding the source of the business on Calgary, It really cuts in so many different ways, but basically about 29% of the business is from new patients. And the remaining 71%, it's switching patients from existing medications or adding Calvary to the existing medication. And when you look at the switches themselves, 65% of the switching is coming from the stimulants and 35% of the switching is coming from non-stimulants. And that is actually a very, very encouraging fact. You know, in looking at the source of the business, we are actually drawing a lot of patients from the stimulant side. A lot of it is due to the AEs that, you know, people cite AEs mainly as one of the major driver actually behind it. And of course, in kids or pediatrics, It's also the parents not willing to put their kids on controlled substances on top of all that. So we're very encouraged by this trend, and it continues to be that way, even from the time we started launching the product in peas and in adults. And then as far as the payers and the step edit and so forth, I mean, it's a really mixed bag. The first PBM contract we had, it's actually Tier 2 preferred, so there is no step through. The second one has a minor step through. But again, if you think about the market, let's say 90% of it is stimulant. So if you have to go through a stimulant, that's really not much of an issue. If you have to go through a non-stimulant, it might just delay your initiation on Calvary by three weeks, four weeks, or whatever. until when you are dissatisfied with the first non-stimulant, clearly. So it is a mixed bag. Different plans have different formularies, different step-throughs or PAs and so forth. And we can, back to my previous answer on the previous question, that is some of the things that we continue to work on and to keep to improve on the coverage and minimize these step-throughs or the different medications patients have to go through before getting Calbrin.
spk01: Very helpful. Thank you. Sure.
spk02: Okay. Seeing no further questions, I would now like to turn it back to Jack Katar for closing comments.
spk04: In concluding our call this afternoon, I would like to emphasize that returning to strong growth is our top priority. We are very pleased with our performance in the first quarter, despite the significant erosion of Trican DXR due to the entry of generics and the typical insurance headwinds. We are confident that our growth products will allow us to offset the impact coming from the loss of exclusivity of Trekendi XR and to return to revenue and operating income growth in 2024 and beyond. Thanks so much for joining us this afternoon. We look forward to updating you on our next call.
spk02: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.
Disclaimer

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