Alkermes Plc Q4 2024 Earnings Call Transcript

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

Question: Paul Matteis - Stifel, Nicolaus & Company, Incorporated - Analyst : I just had one on the orexin program. I was curious, with these studies now well underway and specifically related to the NT II study. I was wondering how close you guys are monitoring adverse events, retention, things like that on a blinded basis, especially as one of the questions to the class is how does tolerability look in larger studies outside of NT1. So any color you could provide there if it is applicable, would be helpful. And maybe just speak to your confidence again in the therapeutic index across broader populations. Thank you.

Question: Paul Matteis - Stifel, Nicolaus & Company, Incorporated - Analyst : Great, thank you.

Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst : Hey, good morning, Rich and team, congrats on a good year of progress. I wanted to ask a quick commercial question and then a follow-up on the pipeline. With regard to the commercial setting, I guess I'm wondering if you are -- not if you're considering, what you're considering in terms of competitive dynamics for LYBALVI and ARISTADA given BMS and J&J, becoming more active in the space. And I think Todd mentioned expanding the sales force. Can you give some color on, call it, the magnitude of that expansion?

Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst : Very good. That's helpful. Quickly on Vibrance-1 and 2, realize that by end of the quarter, you'll give more guidance. But when you consider the NT1 patient population versus NT2, can you provide some color on the interest in the two studies? And could they read out at the same time or is NT1 ahead of NT2 or reverse?

Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst : Excellent, thanks.

Question: Umer Raffat - Evercore ISI Institutional Equities - Analyst : Hi guys, thanks for taking my question. I have two here, if I may. First, a quick one on orexin. Rich, could you remind us if you're expecting the type 2 study, the Narcolepsy type 2 to come before type 1 or not? I know you had commented on the recruitment rates on both trials previously. So I'm just curious. Secondly, on LYBALVI, I'm just still trying to work my way through this. There's -- if we stick to the current gross-to-net and if we stick to the cadence of Rx growth we've seen in 3Q and 4Q, it could imply a number which is below even the low end of your guidance. But on the flip side, we know there was a little bit of gross net delta as well as some inventory effects that were also helping. So if you could just walk us through some of that, that would be very helpful. Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 12, 2025 / 1:00PM, ALKS.OQ - Q4 2024 Alkermes Plc Earnings Call

Question: Amy Li - Jefferies LLC - Analyst : Hey, This is Amy on for Akash. So on OX2, what's your confidence that ALKS 2680 can differentiate on safety versus TAK-861 in NT1? And what do you think the bar is? And another one, if we can. Some of your competitors in the OX2 space are alluding to the ability to proceed into Phase III trials with an expedited Phase IIa. What do you think the FDA wants from their Phase II studies when it came to dose exploration in end. Thanks so much.

Question: Amy Li - Jefferies LLC - Analyst : Got it. Thanks so much.

Question: Jessica Fye - JPMorgan Chase & Co - Analyst : Hey guys, good morning. Thanks for taking my question. A question on the 2025 guidance. What does that contemplate for INVEGA TRINZA as it relates to any risk of generic entry? And where does that litigation stand? And can you maybe characterize how much it contributes to the royalty revenue line? Thank you.

Question: Chris Shibutani - Goldman Sachs & Co. LLC - Analyst : Thank you and good morning. Two maybe broader questions. One, in terms of thinking about clinical development risks for assets for the neuroscience. We've certainly always known that it's very difficult. There's been some recent industry examples where it's been kind of characteristic. Rich, you and your team have been no strangers to going through this. The journey has been long. What are you putting in place with the orexin program that you think informs and helps mitigate some of the risk? And then second, Mark, a broad policy related question, Rich, again, you have had seats at some important tables thinking about the implications of health care policy on your business. And I would really appreciate if you could opine on a couple of points, perhaps if I could touch upon NIH-related funding implications on research, tariffs, IRA, a couple of the big pictures, which you have been helpful in the past look to get your insights as it relates to Alkermes and perhaps broadly to the industry. Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 12, 2025 / 1:00PM, ALKS.OQ - Q4 2024 Alkermes Plc Earnings Call

Question: Chris Shibutani - Goldman Sachs & Co. LLC - Analyst : As always, thanks for the thoughtful responses.

Question: Marc Goodman - Leerink Partners - Analyst : Yeah, can you give us any more color on what's going on with these next-gen erections or when are you going to give us more color on what indications or just anything that you're willing to share just incrementally since we're on a live call here? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 12, 2025 / 1:00PM, ALKS.OQ - Q4 2024 Alkermes Plc Earnings Call And then just secondly, I know I've asked you about business development quite often, and obviously, we're spending a great deal of money on orexins and everyone is excited about it, you should be spending the money. They're just curious what's going on behind the scenes and business development? And if -- should we be surprised if there's a deal or not a deal for anything else this year to kind of add to the pipeline? Thanks.

Question: Marc Goodman - Leerink Partners - Analyst : Thank you.

Question: Uy Ear - Mizuho Securities USA - Analyst : You guys, yeah, thanks for taking your question. Rich, maybe just a follow-up on your brief comment about Medicaid funding. Maybe just help us understand what the sources for VIVITROL is these days, given the shift from opioid to alcohol dependents. And maybe just help us kind of think about if there is in Medicaid cut. How should we sort of think about the potential risk to this product? And along that line, maybe just also help us understand the impact, I guess, from IRA Medicare Part D redesigned for this year and potentially next year? 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. FEBRUARY 12, 2025 / 1:00PM, ALKS.OQ - Q4 2024 Alkermes Plc Earnings Call

Question: Uy Ear - Mizuho Securities USA - Analyst : Could you also maybe talk a little bit about the sources of funding for VIVITROL?

Question: Uy Ear - Mizuho Securities USA - Analyst : Thank you.

Question: Joseph Thome - TD Cowen - Analyst : Hi everyone. Congrats on the quarter and thanks for taking our question. Just really quickly on ALKS 2680. How quickly do you think you also move into pivotal studies in NT1 or NT2 patients upon positive data this year. I guess part of the gating items the initiation of the Phase III studies? And do you think we could see a pivotal study before the end of the year?

Question: Joseph Thome - TD Cowen - Analyst : Great, thanks for the additional color.

Question: Douglas Tsao - H.C. Wainwright & Co - Analyst : Hi, good morning. Thanks for taking the questions. Maybe as a starting point, Rich, I think it would be helpful to just provide some perspective on what you think your competitive advantages are in the recon space Obviously, you have a head start in terms of clinical development across some indications, and it indicates that in future broader ones outside of to sort of wait for the sleep category, you're ahead. But maybe just from a chemistry standpoint, just because obviously, we started to see other companies begin to focus on the erection space. Maybe just walk through some of the challenges that others might experience and why you think that your sort of first-mover advantage will prove to be durable? And then I have a follow-up on the LYBALVI. Thanks.

Question: Douglas Tsao - H.C. Wainwright & Co - Analyst : And Richard, I can, a follow-up in terms of your earlier comments. So in terms of sort of the multiple characteristics that are needed or sort of boxes you need to check in the recon space, you would be sort of cautious when you look at some companies that are purporting to have sort of preclinical data or in vitro assays highlighting the sort of potency of their molecules relative to what you indicated have done just given the sort of need to -- there are the challenges around PK and penetration into the brand. Is that fair?

Question: Douglas Tsao - H.C. Wainwright & Co - Analyst : Okay great. Thank you so much.

Question: Douglas Tsao - H.C. Wainwright & Co - Analyst : Okay.

Question: Joel Beatty - Robert W. Baird & Co. Incorporated - Analyst : Hi, thanks for taking the question. For VIVITROL, what are the key dynamics that impact whether you'll be able to achieve that mid-single-digit growth rate in scripts that was mentioned earlier in the call. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 12, 2025 / 1:00PM, ALKS.OQ - Q4 2024 Alkermes Plc Earnings Call