Alkermes Plc Q1 2025 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Joseph Thome - TD Cowen - Analyst : Hi there, good morning. Congrats on the progress and thank you for taking my question. Maybe the first one, I think in the prepared remarks it was mentioned that the NT2 study has co-primaries of, mean wakefulness tests and ESS and I'm curious if that was an update from the initial ESS being secondary and kind of what led to that. And then maybe as a follow up, I know you and the KOLs have indicated flexible dosing would be very attractive for this patient population. Can you remind us if patients are able to de-escalate between active arms as the study progresses, if they do see an AE, they can kind of stay on active drugs but maybe drop down. Can you comment on that? Thank you.

Question: Joseph Thome - TD Cowen - Analyst : Perfect. Thank you very much.

Question: Charles Duncan - Cantor Fitzgerald - Analyst : Morning, Rich and team. Congrats on a great start to the year. Had a quick commercial question and a pipeline question with regard to the commercial question in terms of Lybalvi, I think you mentioned that you're getting scripts from both schizophrenia and bipolar. I'm wondering if you could break out the relative percentage. And then with regard to the R&D or the pipeline question, you mentioned 2680 being highly potent, and I know we've talked about this before, but is potency the end all and be all, or are there other aspects of 2680 that encourage your investment?

Question: Charles Duncan - Cantor Fitzgerald - Analyst : Got it. Thanks.

Question: James - Stifel - Analyst : Hey, this is James on for Paul. Thanks for taking our question and just a quick one on Orexin, given these studies have now been going on for some time is there anything you can say about safety, at least on a blinded basis and specifically one point of focus and the prior data has been the the couple instances of visual disturbances. So any color on sort of your expectations there for the face twos would be helpful. Thanks so much.

Question: James - Stifel - Analyst : Makes sense. Thanks for the call.

Question: Umer Raffat - Evercore ISI - Analyst : Morning guys, thanks for taking my question. First, just curious how you're defining efficacy in some of the readouts coming up. For example, does the MWT need to be above 30, and I'm asking because it looks like the 10 mg dose, especially in your NT2 trial, might be able to thread the needle on safety on every possible metric, but I'm just curious how efficacy success could be defined. Secondly. On REM sleep intrusions during wakefulness and whether that drove some of the visual hallucinations or blurred vision, I'm just curious, how should we balance some of the underlying REM-related intrusions and possible visual disturbances versus the observation of visual disturbances only happening at higher doses and not across doses? Is it more C-Max or not? Just curious how you think about that overall. Thank you.

Question: Umer Raffat - Evercore ISI - Analyst : Thank you so much.

Question: David Amsellem - Piper Sandler - Analyst : Thanks. So just taking a step back with the advancement of 2680 and other Orexin 2 receptor agonists and potentially other indications, what are your latest thoughts on biz Dev and M&A and how aggressively are you going to be pursuing other assets to bolster the neuroscience pipeline and with that in mind, can you talk about how large of a transaction you would contemplate. Thanks.

Question: Abdul - JP Morgan - Analyst : Hi, this is Abdul on for Jess. Just two quick questions for your key commercial products. Can you touch on how you think about the contribution of volume versus price to sales this year? And then we've heard some investors worried about the possible cuts to Medicaid. Can you remind us what portion of Vivitrol involve you know Aristada are covered by Medicaid? Thank you.

Question: Amy - Jefferies - Analyst : Hey, this is Amy on For Akash . Thanks so much for taking a question. Just, one question on your orexin program. If you look at TAC-861's NT1 data, we're seeing worse AEs with the 52 mg dose compared to the 7 mg daily dose, even though the same amount of drug is being delivered. Just curious, what is your bar on safety and how confident are you that you can show better safety than TAC-861, in an NT1 population at your go forward dose?

Question: Marc Goodman - Leerink Partners - Analyst : Yes, I've been reading a lot about these government cuts and some of them have been to abuse programs. I was just curious if any of this was impacting Vivitrol at all, or do you expect any changes at all in those funding? And then second of all, just on Lybalvi, any changes in just patterns that you've seen just with the Bristol launch of the drug that's been out there for a long time now. Thanks.

Question: Jason Gerberry - Bank of America - Analyst : Hey guys, thanks for taking my question. I appreciate all the updates on the on the tariff stuff. So it sounds like the punch line here is everything from API to finished is going to be sourced in the US and never go through customs. And so if there's, theoretical concerns around tariffing of transfer pricing, well, it sounds like. You know you guys use like a royalty payment back to your Irish sub and in any sort of transfer pricing tariff stuff like I don't know for that to have any impact seems like it's more of the realm of tax legislation so just wanted to make sure you know folks understood that appropriately. And then, just separately with the vibrance one, I'm wondering what we can learn about the visual disturbance AE at all because, we haven't seen these AEs in the in the narcolepsy type 1 population. I think you guys had indicated you'll do some added ophthalmic testing of some sort in these patients. I'm wondering if that'll be part of the early 3Q update as well. Thanks. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 01, 2025 / 12:00PM, ALKS.OQ - Q1 2025 Alkermes Plc Earnings Call

Question: Jason Gerberry - Bank of America - Analyst : Alright thanks guys.

Question: Leo Timashev - RBC Capital Markets - Analyst : Yes, hey guys, thanks for taking my question. I had one on the Orexin program. You mentioned in the prepared remarks that you're also thinking about reins for cognition, attention. I'm curious if you can gather any data on those end points in the ongoing phase 2s or in the open label extension portions if there's any, formal endpoints you can evaluate there and then. I'm curious if any of those aspects can also potentially pull through into stimulating activity of erections and if there's any potential for liability and if you can test for that as well in the phase two. Thanks.

Question: Uy Ear - Mizuho Securities - Analyst : Hi guys, yes, thanks for taking our questions. Given the upcoming data readout, maybe just help us set expectations for the, vibrance one. Just what in what in terms of efficacy are you expecting and safety and if you're, if not that, then maybe just remind us what was the effect size that was assumed in the for the phase two study and the powering. Thanks.

Question: Uy Ear - Mizuho Securities - Analyst : Okay, thanks. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 01, 2025 / 12:00PM, ALKS.OQ - Q1 2025 Alkermes Plc Earnings Call

Question: Joel Beatty - Baird - Analyst : Thanks for taking the question. For VIVITROL, with sales from that product being particularly strong over recent quarters, could you discuss the potential to maintain revenue from that product in 2027 and beyond upon the potential entry of generic competition?

Question: Joel Beatty - Baird - Analyst : Thank you.

Question: David Hoang - Deutsche Bank - Analyst : Hi there, thanks so much for taking the questions. So I just want to ask, given the cadence of phase two data that you'll get here in NT1, NT2, and I, how you think about having, timing of regulatory interactions with the FDA around things such as. And the phase two meetings, and such. And then in terms of heading into phase three, do you have kind of an idea of, how many doses would be preferable to take you to phase 3 and then eventually commercialization. Thanks so much.

Question: Doug Tsao - H.C. Wainwright - Analyst : Hi, good morning and thanks for squeezing me in. Maybe just I wanted to follow up on Project Saturn, and obviously you presented some really interesting preclinical day or preclinical data at your erection analyst meeting last year. I'm just curious to get your sort of thoughts on sort of the decision points that will be made. As you think about bringing molecules into development across these different indications outside of the sleep space, and is it a situation where you might ultimately bring multiple assets forward for sort of different, sets of uses.

Question: Doug Tsao - H.C. Wainwright - Analyst : Just as a follow up. I'm curious, is it, does the ultimate indication selection depend a little bit on the sad mad data, meaning, just given the sort of profiles that you see in terms of exposure or maybe some other pharmacological, sort of end points that you're looking at, help you decide, this molecule might be better suited for one indication versus the other.