Alkermes Plc at Goldman Sachs Global Healthcare Conference Transcript

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

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : Yeah. No, I think that's very true. There's a certain simplicity now, which is quite elegant and yet you and Alkermes seem to like to do difficult things. Neuroscience, by definition is a complex background biology, understanding diseases, patients, I think was this supposed to be the decade of the brain and now, I think we're kind of pushing it into the exit better half of this decade for my sake. But from the standpoint of just thinking about your focus in neuroscience and you've been on either side of the legal table with some of the larger players with Biogen and then became partners there. You know, the ecosystem. Talk about where you're seeing some attractive opportunities to be a pure-play neuroscience company. But with a growing portfolio, whether they be pipeline prospects, I know we have established commercial aspects, but I think your investor community really is very much focused on the future and pipeline opportunities, et cetera. So neuroscience, not simple, you've been in a while what you see as attractive where.

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : I think that always has been one of the core competencies sort of the engineering capabilities and essence, and that was very much the revenue platform that is now receding, but historically has been the case. So perhaps we'll dive into the actual Orexin program since that tends to be the real focus of attention, bringing us up to date with where we're at. We just recently had a meeting down in Texas. I think Sleep, you guys had a poster, some of the competitors have begun to show portion of their cards progressively. Just update us from the Alkermes perspective post the Sleep meeting.

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : There is always an optimal profile from an efficacy standpoint, but the safety tolerability aspect tends to be what we worry for a lot of our time in the business, thinking about drugs that will be used quite broadly misused overdose, not taken et cetera, skipped, et cetera. Talk specifically about how to interpret adverse event data coming from all of these programs and how that actually translates to in the real world people talk about visual disturbances, just the whole world, just conjures up all sorts of worries, but contextualize adverse event profile and what you think is going to be a impactful relevant, you know, orexin commercially available. What are we willing to accept in terms of tolerability by the time we get to the end of the road and get excited about a revenue generating product.

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : And naturally, this is a chronic condition. Patients are expected to theoretically be on therapy for an extended period of time. What do we think about the natural history of some of these things that we're observing. You often see adverse events that can be modulated with dose pauses or gradual progression of dose increases is there any indication either from the science, the biology or a clinical trial experience thus far that suggests that idiosyncratic can happen at any time versus initiation of therapy skewed, it just give us a sense?

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : And then on the adverse event profile the scientific basis for thinking that adverse events, if they occur initially will resolve it --

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : There was -- maybe going back six months to a year. This hypothesis about NT type 1 patients and type 2, and how much dosing would need to be potentially scale. And with NT2 and IH, you've reported some data and interesting observations that actually went counter to some of that (technical difficulty) in terms of whether you really needed to amp up dosing to levels that theoretically might encroach upon you now thoughts of more adverse events possibly coming up. So NT type 2, vibrance two study Phase 1b results. 10 and 14 and 18 milligrams I have for the Phase 2 versus 5, 12 and 25 milligrams. Talk about the strategy and the mapping of the doses that you've chosen there. without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. JUNE 11, 2024 / 2:40PM, ALKS.OQ - Alkermes Plc at Goldman Sachs Global Healthcare Conference

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : The complexity of the disease. Here's a little bit challenging. There are some beautiful examples of keep it simple stupid. One of the reasons that like the statins did so well like and will draw some blend your LDL less than 100, it was like made on Madison Avenue. Obesity drugs, you know the number on the scale oversimplification but works beautifully. Irritable bowel syndrome drugs, looking at the iconography that the patients had to assess clinically we won't even go into detail here. MWT, talk about this is a metric that seems to be validated from a scientific, I believe regulatory standpoint as well. But then how does that interface with the real world in terms of how clinicians practice and manage patients and how a patient is there going to be an [Apple app] my MWT or something --

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : And then -- without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. JUNE 11, 2024 / 2:40PM, ALKS.OQ - Alkermes Plc at Goldman Sachs Global Healthcare Conference

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : And then as you're sort of pre-commercial folks, look at the potential landscape here, how developed is that landscape? And we think about Alzheimer's treatments and it's like well there's actually a certain limited number of pet scans that are weighing down the corners of buildings and hospitals. What about sleep labs of the necessity of having the infrastructure in place to capture patients and --

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : Let's talk about additional indications, idiopathic hypersomnia. Actually, you've shared some commentary about very specific a decision that was made in terms of your planning how much further you'll press into that opportunity and it ties into bigger picture issues that you're quite familiar with from your tenure as being a CEO and being in the industry IRA related implications. So just clarify for us where IH fits in and your thinking on that decision about weather to (technical difficulty) not at this time.

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : Okay. I know that was one of my follow-on questions here because I think the capabilities and the scientific work that's really been embedded within the company for close to a decade. And in 2016 is a year that I have in my mind in terms of when you really sort of committed to developing things scientifically. So we have another compound coming by the end of this year in terms of thinking about --

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : Okay, terrific. Is ALKS 2680 going to get a nickname that we're going to be able to do other beyond the numbers soon.

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : Okay. Here it rolls off the tongue reasonably well. (laughter) Let's talk about the commercial portfolio, the LYBALVI, which obviously is another classic story for Alkermes, I think where there was. An element of under appreciation about how this drug could do and particularly the beginning and you guys were kind of modest, I think the initial year one guidance, like how we 'll quietly do $50 million to $70 million in revenues and you soundly beat that. So that was a fun period of time for the stock because there was a nice cadence of being raised. Now we're getting kind of towards adolescents is a product that's out there. It's a great category, but where's the drug finding its traction and how much can you sort of push on commercial performance through things like direct to consumer, et cetera? How much is it just like the natural steeping and growing versus yeah, if we put more muscle behind this we can really push it harder. What's possible in that category with this drug?

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : And then you do provide some milestone markers in terms of the number of potential prescribers. I think 22,000 is kind of the denominator here. We think about the US first quarter, it was 66,000. Is the trajectory continuing to progress a pace, so --

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : The landscape is poised to potentially change novel mechanisms of action, muscarinic agents, potential approval at the end of September. A couple in the development stage, investors tend to be quite keen, the backdrop is often about have we haven't seen anything new for quite a long time and that there's an attractive profile. Maybe how does this translate? What does this do in terms of any potential turbulence of the trajectory will evolve the why and why not?

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : When we think about iterations of product profile and presentation, the long acting injectable is something that you have been active with ARISTADA. And I've always been kind of struck how in the US the percentage of patients or the penetration of long acting injectables, which for all sorts of reasons actually sounds like a pretty logical solution, particularly to manage patients hasn't really gotten that far. I remember talking to you guys maybe half decade ago and it was kind of in that 10% to 15% in the US, little bit higher in Europe, where there's a little bit of an enforcement. It's like you need this drug this is the version you're going to take. Where we would penetration, and I ask that in part again, because the investment community is contemplating with the next generation mechanism of action is just like a long acting injectables that could be really cool. You're already living it, so inform us what's going on with the long acting injectable dynamic and why maybe we're at the place where we are at in the US in terms of penetration there.

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : Let's turn a little bit a click bait, GLP-1 that's now officially in the transcript. So there's hypotheses about the potential based upon receptors in the brain that it may have some tweaking benefits in addictive behaviors. VIVITROL is very much, one of the well established soldiers in the battlefield of trying to address addictions. Any perspectives on what you're observing whether you believe this is possible, any chances to play together, competition, just any thoughts there?

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : Send a message to Frank Baldino.

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : Exactly.

Question: Chris Shibutani - Goldman Sachs Group, Inc. - Analyst : That was definitely going to be my close in terms of the profitability profile, which is a commitment. And I think that there's tremendous scope to watch that growth trajectory there, but then that cash and sort of capital allocation prioritization there. So I think that that's something that should be well received and thinking about the broadening there because certainly we agree from the standpoint of when we look at your outlook and the opportunity to express that point of view through share repurchases. I think gives you another tool and your toolkit, diversification of what are the core theses as we continue to watch the development of a very exciting opportunity for directions, but also now with this leaner, more focused company with profitability and growth, it's great to be able to see you flex that opportunity to return cash to shareholders as well. So I think we covered a lot. How do we do, Sandy? Okay?