Alkermes Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 1, 2025

There are 15 speakers on the call.

Operator

and welcome to Alchemy's First Quarter twenty twenty five Financial Results Conference Call. My name is Maria, and I'll be the operator for today's call. All participant lines will be placed on mute to prevent background Please note that this conference is being recorded. I will now turn the call over to Sandra Khoemps, Senior Vice President of Investor Relations and Corporate Affairs. Sandy, you may now begin.

Operator

Good morning. Welcome to the Alkermes plc conference call to discuss our financial results and business update for the quarter ended 03/31/2025. With me today are Richard Pops, our CEO Todd Nichols, our Chief Commercial Officer Blair Jackson, our Chief Operating Officer and Doctor. Craig Hopkinson, our Chief Medical Officer. A slide presentation, along with our press release, related financial tables, and reconciliations of the GAAP to non GAAP financial measures that we'll discuss today are available on the Investors section of alkermes.com.

Operator

We believe the non GAAP financial results in conjunction with the GAAP results are useful in understanding the ongoing economics of our business. Our discussions during this conference call will include forward looking statements. Actual results could differ materially from these forward looking statements. Please see slide two of the accompanying presentation, our press release issued this morning, and our most recent annual and quarterly reports filed with the SEC for important risk factors that could cause our actual results to differ materially from those expressed or implied in the forward looking statements. We undertake no obligation to update or revise the information provided on this call or in the accompanying presentation as a result of new information or future results or developments.

Operator

After our prepared remarks, we'll open the call for Q and A. And now I'll turn the call over to Richard for some opening remarks.

Speaker 1

Thank you, Sandy. Good morning, everyone. I'm going to start by recognizing the passing of our colleague and friend, Ian Brown, following a courageous battle with cancer. Known to many of you, Ian represented the best of our company in many ways, through his intellect and his professionalism, his kindness and his humanity, and his sense of humor. I wanna thank all of you who sent along your condolences and remembrances.

Speaker 1

It meant a lot to all of us here. As you know, Blair Jackson has been serving in the role of interim principal financial officer since he went on medical leave in early twenty twenty four. Blair's done an excellent job among his other responsibilities and will continue to serve in that role as we look now to identify Ian's successor. So with that said, let me say that we have a few things to cover this morning and I'm gonna dive right in. On today's call, Todd's gonna start with an overview of the performance of our commercial products.

Speaker 1

Blair will review the financial results for the quarter and provide some insights regarding our positioning within the current macroeconomic conditions. And given the exciting progress we're making across the Orexin portfolio, Craig Hopkinson, our Head of R and D and CMO, will provide an update. You'll be hearing from him more going forward as we move into a data rich phase of the ALKS 02/1980 program. So here's my perspective on where we stand in May 2025. The summary is that we're well positioned and we're right on plan.

Speaker 1

Our first quarter commercial performance was solid and slightly ahead of expectations that we provided on our last earnings call. Each of our medicines has a differentiated value proposition, and we're focused on maximizing the potential of the Evalvi, ARISTADA and VIVITROL in their respective markets. Financially, our first quarter results were on plan, and this morning we reiterated our financial expectations for the year. Across the commercial and financial elements of the business, we continue to focus on driving growth and driving profitability. The exciting new developments are happening in R and D.

Speaker 1

This will be a pivotal year across the orexin-two development landscape, and Alkermes is at the forefront of development in this exciting potential therapeutic category. Our ALKS 2680 Phase II program is designed to generate a substantial dataset that characterizes the efficacy, safety, and tolerability of a wide range of doses across narcolepsy type one, narcolepsy type two, and idiopathic hypersomnia. As we had hoped and anticipated, as we activated sites around the world and investigators gained experience with our study, the Phase II program began to accelerate and it's advancing now with real momentum. The NT1 study Vibrance I is now fully enrolled. We now expect top line results early in the third quarter.

Speaker 1

The NT2 study, Vibrance II, is enrolling very well. We expect to complete enrollment mid year with data to follow in the fall. The results of Vibrance I and Vibrance II will represent two of the most substantial data sets to be generated in this therapeutic category to date, and will provide important information as we advance the program toward planned Phase III studies. We are on the cusp now of potentially transformative data, and we're planning for exciting second half of the year. Finally, with respect to the macro environment, Boire will give you some details and I'll be happy to answer questions you might have.

Speaker 1

But in summary, we are paying attention to two main topics: Medicaid changes under reconciliation and FDA. With respect to potential tariffs and foreign reference pricing, we are in an advantageous position because we manufacture all of our proprietary products in The US, in the state of Ohio, and we do not commercialize them in markets outside The US. So with those introductory comments, I'll turn it over to Todd to take us through the commercial results for the first quarter.

Speaker 2

Thank you, Rich, and good morning everyone. In the first quarter, we recorded net sales from our proprietary product portfolio of 244,500,000 slightly above the expectations that we outlined in February, reflecting 5% year over year growth, primarily driven by LYBOLVI. Starting with VIVITROL, net sales in the first quarter were $101,000,000 VIVITROL performance continues to be largely driven by the alcohol dependence indication, which is the primary focus of our promotional efforts and currently accounts for approximately 75% of VIVITROL volume. Looking ahead, we continue to expect VIVITROL net sales for 2025 in the range of $440,000,000 to $460,000,000 For the ARISTADA product family, in the first quarter, net sales were $73,500,000 In 2025, we continue to expect ARISTADA net sales in the range of $335,000,000 to $355,000,000 Turning to LIVALVI, net sales grew 23% year over year to $70,000,000 primarily driven by underlying TRx growth of 22%, with growth coming from both the schizophrenia and bipolar one disorder indications. As we indicated on our last earnings call, gross to net adjustments were approximately 31% in the first quarter, and we expect will remain consistent in the low to mid 30% range for the remainder of 2025.

Speaker 2

For the full year, we continue to expect LIPOLVI net sales in the range of $320,000,000 to $340,000,000 We continue to make strategic investments designed to drive awareness and uptake of our psychiatry franchise products. In the first quarter, we completed the expansion of our psychiatry sales force, which is now fully deployed in the field with a focus on maintaining a competitive share of voice for LYBOLVI and reaccelerating growth for ARISTADA. We expect to see tangible contributions from the new sales positions within a few quarters. Across our proprietary products, inventory at the wholesale level was drawn down as expected during the first quarter and is now in a normal range for all three products. Each of our products offers a unique value proposition in their respective category, supported by established efficacy, long term clinical data and real world patient experience.

Speaker 2

We're off to a solid start in 2025 and believe we are well positioned to achieve financial expectations for the year. We look forward to sharing our progress with you. With that, I will pass the call

Speaker 3

to Blair. Thank you, Todd. Our first quarter performance was slightly ahead of our expectations and we remain on track to achieve our financial guidance for the year. Macroeconomic conditions are dynamic and rapidly evolving. We are well positioned with more than $900,000,000 of cash and investments on the balance sheet, a business generating substantial cash flow, significant growth opportunities ahead and the ability to adapt quickly to the environment.

Speaker 3

We remain focused on executing against our strategic objectives for the year and are preparing for the key data readouts from the ALKS two thousand six hundred eighty Phase II narcolepsy studies later this year. Before I detail our financial results, I'll provide a brief overview of our position with respect to the macroeconomic policy landscape. Starting with our manufacturing footprint. All of our proprietary products are manufactured at our Ohio facility and are sold exclusively in The United States. The vast majority of our manufacturing supply chain is also sourced domestically.

Speaker 3

We import a small amount of active pharmaceutical ingredients from certain suppliers abroad, but this represents less than 5% of our cost of goods sold. Additionally, we maintain significant safety stock of API, which if necessary could provide flexibility to adapt our supply chain sourcing without significant disruption. We will continue to carefully monitor the evolving policy environment for any potential impacts to our business, but believe we are in a strong position with our U. S.-based manufacturing and supply chain. Turning to our financial results for the quarter, we generated total revenues of $306,500,000 slightly ahead of the expectations we outlined on our fourth quarter call.

Speaker 3

These results were driven by our proprietary product portfolio, which grew five percent year over year. For our portfolio of proprietary products, we generated net sales of $244,500,000 As we move into the second quarter, we expect Q2 net sales from this portfolio in the range of $260,000,000 to $280,000,000 Manufacturing and royalty revenues were $62,000,000 for the first quarter, including revenues of $27,800,000 from VUMERITY, dollars seventeen point seven million from the long acting INVEGA products and approximately $9,000,000 from Risperdal Constant. Turning to expenses, cost of goods sold were $49,200,000 compared to $58,600,000 for Q1 last year, primarily reflecting efficiencies following the sale of our Athlon based manufacturing business last year. R and D expenses were CAD71.8 million compared to CAD67.6 million for Q1 last year. This consisted of focused investments in our neuroscience development programs, primarily related to our ongoing Phase II studies of ALKS two thousand six hundred eighty in narcolepsy type one and narcolepsy type two, as well as the recent initiation of our Phase two study in idiopathic hypersomnia.

Speaker 3

We expect R and D expense to increase modestly in the second quarter and remain fairly consistent for the remainder of the year. SG and A expenses were $171,700,000 compared to $179,700,000 for Q1 last year, reflecting the mix of promotional activities supporting our commercial products as we continue to focus on driving efficiency. For trending purposes, we expect SG and A expense in the second quarter to remain fairly consistent with Q1 levels, with a modest step down in the second half of the year. We continue to focus on driving profitability. In Q1, we generated GAAP net income of $22,500,000 EBITDA of $22,800,000 and adjusted EBITDA of $45,600,000 Turning to our balance sheet, we ended the first quarter in a strong financial position with $916,200,000 in cash and total investments.

Speaker 3

We continue to have $200,000,000 of remaining share repurchase authorization and going forward, we may opportunistically repurchase shares dependent on market conditions and the capital needs of the business. The financial performance we delivered in the first quarter was slightly ahead of our expectation and provides a strong foundation to achieve our financial guidance for the year. I'll now hand the call to Craig for an update on our research and development pipeline.

Speaker 4

Good morning. I'm pleased to join you with an update on the development programs for our Orexin-two receptor agonist portfolio. Our ALKS2680 program focusing on central disorders of hypersomnolence is advancing with strong momentum. Investigators across the Phase two program are gaining experience in the studies and with the clinical trial network now largely established screening and enrollment accelerated significantly in the narcolepsy studies in the first quarter. We look forward to further harnessing that interest and enthusiasm in our idiopathic hypersomnia Phase two study and for potential Phase three studies.

Speaker 4

At the same time, we are moving forward aggressively to expand our research into new disease areas for orexin-two receptor agonists. A couple of years ago, we initiated Project Saturn with the goal of advancing new molecules for a broad range of disorders. This year we plan to start the clinical work underpinning the strategy. The orexin-two receptor agonist pathway has broad potential applicability and we are a leader in evaluating the utility of this novel pharmacology. With that as an introduction, let's start with ALKS two thousand six hundred eighty.

Speaker 4

In the Phase Ib study we completed last year, ALKS two thousand six hundred eighty demonstrated a highly potent clinical profile in the intended patient populations. In that study, we established initial safety, efficacy, tolerability, and dose response profiles across narcolepsy type one, narcolepsy type two, and idiopathic hypersomnia. The key objective of the Phase two program is to more fully elaborate the dose response curve in larger patient populations, define the lower and upper limits in terms of both efficacy and tolerability, and inform dose selection for the planned Phase three program. The Phase two program is well underway. Vibrance one is a six week double blind placebo controlled parallel design study in narcolepsy type one or NT1.

Speaker 4

NT1 is defined by an absence of orexin producing neurons in the hypothalamus. People living with NT1 experience both excessive daytime sleepiness and cataplexy, which is a sudden loss of muscle tone. The primary endpoint of Vibrance1 is the change from baseline in the maintenance of wakefulness test or MWT. MWT is a quantitative measure of how long patients can stay awake. The study will also evaluate secondary endpoints including change from baseline in weekly cataplexy rates as well as change from baseline on Epo sleepiness scale which is a patient reported measure of a patient's situation or likelihood of falling asleep.

Speaker 4

As clinical trial sites were initiated and gained experience at the studies, investigator interest intensified and enrollment in Vibrance one is now complete. We expect to report top line data from Vibrance one early in the third quarter. Narcolepsy Type '2 or NT2 is a more heterogeneous disease compared to NT1. People living with NT2 may have more functional or normal orexin systems, however they still experience excessive daytime sleepiness. Vibrance II is an eight week double blind placebo controlled parallel designed Phase II study in NT2.

Speaker 4

In this study we plan to evaluate changes from baseline in both MWT and Epworth as dual primary endpoints. Vibrance II will generate the largest dataset to date for an orexin-two receptor agonist in the NT2 population. We have strong momentum in screening and enrollment and expect to complete enrollment mid year and have top line data in the fall. The most recent development in the ALKS 2,680 program is the initiation of Vibrance III, our Phase II study in idiopathic hypersomnia. Vibrance III is similar to Vibrance II in terms of the three doses being studied: ten, fourteen and eighteen milligrams as well as the eight week duration of the randomized double blind placebo controlled parallel design.

Speaker 4

The primary endpoint in this study is the change from baseline and Epworth Scale. The study will also evaluate changes in idiopathic hypersomnia severity scale as a secondary endpoint and we expect data from this study in mid-twenty twenty six. We're focused on capitalizing on our momentum and preparations for Phase three studies so that we can move as quickly as possible once we have Phase two data in hand. We've established a robust clinical trial network with more than 45 sites initiated to support the Phase two program and expect to be able to leverage this network and our clinical relationships to streamline operational study startup timelines for Phase three. Preparations for other Phase three work streams including manufacturing of clinical supply, study design planning and key regulatory interactions are also underway.

Speaker 4

We expect to exit Phase II with strong momentum and are focused on carrying that momentum forward into Phase III. I'll finish with a quick update on our Project Sapna initiative. Orexin-two receptor agonists have been shown pre clinically to activate neurocircuitry associated with mood, attention, vigilance and cognition. Project Saturn is focused on harnessing these effects in the treatment of other diseases outside of hypersomnolence disorders. We are on track to advance two additional orexin-two receptor agonists into first in human studies this year.

Speaker 4

ALKS four thousand five hundred ten will be the first with single ascending dose studies expected to commence in the coming weeks. ALKS seven thousand two hundred ninety is anticipated to follow later this year. These two compounds share certain similarities with ALKS two thousand six hundred eighty that will have their own unique pharmacokinetic and pharmaceutical properties. Once the initial pharmaceutical profiles are established in healthy volunteers we plan to move quickly into disease relevant studies and to establish proof of concept indications of interest. The spectrum of disorders under consideration ranges from rare neurodegenerative and neurodevelopmental diseases to broader neuropsychiatric disorders, each seeking to harness the orexin system to drive wakefulness, attention, cognition and activate downstream neurocircuitry related to mood and other domains.

Speaker 4

Our preclinical work is ongoing and continues to support the potential of the orexin pathway. Alkermes is well positioned as a leader in development in this exciting new therapeutic category in sleep disorders and beyond. And with that, I'll hand the call back to Rich.

Speaker 1

Great, thank you Craig. I'll finish up. So across the business, we're executing across our strategic objectives, focusing on the initiatives that we believe represent our greatest growth opportunities. Let me close with just a couple of thoughts. First, with respect to the macro landscape, we are well prepared to operate in this kind of environment.

Speaker 1

The patient populations that our commercial medicines are indicated for have always demanded a high level of engagement with policymakers and regulators. Our presence and capabilities in these areas become even more important against the backdrop of rapid and significant change. Our focus is on advocating for policies that maintain access to care for our patient populations, interacting with regulators to support continuity of critical regulatory work streams, and identifying opportunities for efficiency in a thoughtful manner. We've been doing this for a long time, and we'll continue that work. Next, irrespective of the political environment, what will continue to drive valuations in our industry is the discovery and development of important new medicines with therapeutic value for patients and long potential patent lives.

Speaker 1

This is why the orexin development program is so central to our planning new molecules based on new biology. Our program begins with narcolepsy (in ALKS 2,600 and has shown potential to extend beyond that into other exciting neuroscience indications. We've been building this type of valuation potential into the business thoughtfully over the last several years, and we're excited to be on the brink of important new datasets this year. So with that, I'll turn it to Sandy to run the Q and A.

Operator

Great, thank you very much. Maria, would you please open the call for Q and A? Of course. Thank you. At this time, we will be conducting a question and answer session.

Operator

A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue. We ask that analysts limit themselves to one question and a follow-up so that others may have an opportunity to ask questions. Our first question comes from Joseph Thome with TD Cowen. Please proceed with your question.

Speaker 5

Hi there. Good morning. Congrats on the progress and thank you for taking my question. Maybe the first one, think in the prepared remarks it was mentioned that the NT2 study has co primaries of mean wakefulness tests in ESS and 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 deescalate between active arms as the study progresses?

Speaker 5

If they do see an AE, they can kind of stay on active drug or maybe drop down. Can you comment on that? Thank you.

Speaker 4

Yes, sure. I'll start off with the question on Epworth. Epworth has always been an important assessment and been one of our endpoints for Vibrance II. And considering other late stage studies in the competitive landscape and our expectations for global regulatory interactions as we plan to prepare for potential Phase three studies, we decided to elevate it to a dual primary endpoint. So it's not a co primary endpoint, but a dual primary endpoint in the NT2 study.

Speaker 4

With regard to the flexible dosing, during the actual double blind portions of the study, patients are assigned to a dose And then in the open label extension portion of the study, all patients will initiate on the mid dose and can trade for a period of time to the higher or the lower dose from that mid dose. So we'll gain quite a bit of experience hearing patient motivations and physician motivations in terms of that titration from the Phase II data, that will be really informative as we start planning for Phase III.

Speaker 1

Perfect. Thank you very much.

Operator

Our next question comes from Charles Duncan with Cantor Fitzgerald. Please proceed with your question.

Speaker 6

Morning, Rich and team. Congrats on a great start to the year. Had a quick commercial question and then pipeline question. With regard to the commercial question in terms of LIVALBI, 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.

Speaker 6

And then with regard to the R and D or the pipeline question, you mentioned 2,680 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 two thousand six hundred eighty that encourage your investment?

Speaker 2

Yeah, hi, Charles. Good morning. This is Todd. I'll start with the commercial question for the LIVALVI. For TRxs, it's roughly about a fiftyfifty split for schizophrenia bipolar.

Speaker 2

For new patient starts, we see it more of a trend towards bipolar. So it's approximately fifty five percent for bipolar within Levalvi.

Speaker 4

From a potency perspective, potency is just one aspect of what we built into the profile of ALKS two thousand six hundred eighty. Obviously, it's a true once daily agent. We believe that's important. We've got dose flexibility with a wide therapeutic index. And I think those different aspects collectively are really important.

Speaker 4

And I think this sort of health firm in the results of our Phase 1b study, where I think we're the only agent that has positive data across all three patient populations: NT1, NT2, and IH.

Speaker 6

Got it. Thanks.

Operator

Our next question comes from Paul McKiss with Stifel. Please proceed with your question.

Speaker 7

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 in the prior data has been the couple instances of visual disturbances.

Speaker 7

So any color on sort of your expectations there for the Phase 2s would be helpful. Thanks so much.

Speaker 4

Obviously, it's not appropriate for us to comment too much on blinded data from a study. And for that purpose, we have an independent data safety monitoring board that we've assigned. The DSMB is charged with the oversight of safety across the entire study. As part of that, they obviously are looking at things like visual adverse events and other aspects of the safety as well, including lab parameters. At this point in time, they've met on a regular basis and have given us a green light with no modifications to the study.

Speaker 7

Makes sense. Thanks for the color.

Operator

Our next question comes from Umer Raffat with Evercore ISI. Please proceed with your question.

Speaker 8

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 thirty? And I'm asking because it looks like the ten milligram dose, especially in your NT two 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.

Speaker 8

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 Cmax or not? Just curious how you think about that overall. Thank you.

Speaker 4

So maybe starting with your last question first. I think the amount of information we have on visual disturbances is really not sufficient for us to draw any meaningful conclusions at this point in time. This is obviously something that we're studying more fully in the Phase II program. And to the extent that we can do exposure relationships, we'll be able to do that more accurately once we have Phase II data in hand. The first question Sandy was?

Operator

Define efficacy threshold, does it have to be above Yes,

Speaker 4

the efficacy thresholds that I can speak in broad terms. Mean, think the way we've looked at efficacy is really through two lenses. There's the lens of what's currently approved and on the market and obviously those are sub ten minutes improvements in MWT. And then there's the lens through which the orexin agonist had the potential of getting to more normal wakefulness during the daytime hours. For us it's not only the thresholds we achieve, but the pattern of those thresholds.

Speaker 4

In other words, really striving to have a normal sort of wakefulness during the daytime hours dropping below that threshold in the evening hours to promote more normal nighttime sleep, think is a really important component. And to that end, a low orexin cone in the evening hours with the once daily agent may actually have benefit.

Speaker 1

This is something we're studying more completely in our Phase two studies. Hey Umer, it's Rich. I just want to jump in a little bit on the second part of your question about the REM sleep intrusion. So for those who don't follow the field as much, orexin-two receptor agonist would suppress REM sleep and so one of the characteristics of NT2 for example are these sleep onset REM periods. So you could theoretically have some type of visual disturbance, I.

Speaker 1

E. A hallucination as a marker of a lack of efficacy. And I think other programs may have even seen that. What we described in our NT2 NIH study, one patient in each was very different. There was just a transient blurred vision in one case and transient light sensitivity in another.

Speaker 1

So we didn't interpret that as an intrusion of REM sleep or a failure of efficacy.

Speaker 4

Thank you so much.

Operator

Our next question comes from David Amsellem with Piper Sandler. Please proceed with your question.

Speaker 9

Thanks. So just taking a step back with the advancement of 2,680 and other orexin-two receptor agonists in potentially other indications, what are your latest thoughts on biz dev and M and 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.

Speaker 3

Hi, David. This is Blair. I'll answer that question. I think as we look at our pipeline moving forward, as you said, we're really excited about the 02/1980 program and the expansion of the orexin franchise further and we think that's going to be quite beneficial to the company over the coming years. That being said, we would like to bring in additional assets to bolster the pipeline, if that makes sense, if that fits with the strategy of the business and if we can find an asset that we can add value to through our development program.

Speaker 3

So we're looking across the range of the development cycle from Phase one through mid stage, etcetera. I don't think I'll comment on the size of the opportunity that will really depend on what we're looking at and what phase it's in. But I think, we plan to maintain the business in a profitable stance in the foreseeable future. And so bringing in additional assets and clinical catalysts is something we're looking for.

Speaker 10

Okay, helpful. Thank you.

Operator

Our next question comes from Jessica Fye with JPMorgan. Please proceed with your question.

Speaker 11

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 worry about the possible cuts to Medicaid.

Speaker 11

Can you remind us what portion of VIVITROL, LYBOLVY and ARISTADA are covered by Medicaid? Thank you.

Speaker 2

Yeah, I'll start with the first part of that as well. So, there's always going to be a contribution of pricing. We do expect the typical seasonality with gross to net deductions. So, we expect that will widen a little bit in Q2 for the products and then normalize for Q3 and Q4. But the majority of our expectation is based on volume growth.

Speaker 2

So, expectation and what we're seeing in the marketplace is healthy growth across Lovolva, ARISTADA and VIVITROL. Second question in terms of Medicaid contribution overall, it's relatively similar for all three products. It's in about 45% to about 50% range for all three products.

Speaker 1

Thank you.

Operator

Our next question comes from Akash Tewari with Jefferies. Please proceed with your question. Hey, this is Amy on for Akash. Thanks so much for taking our question. Just one question on your Orexin program.

Operator

If you look at CAC861's NT1 data, we're seeing worse AEs with five point two milligram dose compared to the seven milligram 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 TAC861 in an NT1 population at your go forward dose?

Speaker 4

Yes, at this point in time, it's important to note that we're obviously in very different portions of our clinical development program. And essentially with what Takeda has been seeing with sort of BID dosing maybe relating to the fact that they're seeing two Cmax peaks. The profile of ALKS2680 is truly once daily promoting sort of wakefulness during the daytime hours dropping below efficacious concentrations and allowing for more normal nighttime sleep. And so we're looking forward to our phase two data, and we'll be able to have a far more color on that once we have the data in hand.

Operator

Perfect. Thank you. Our next question comes from Mark Goodman with Leerink Partners. Please proceed with your question.

Speaker 2

Yeah. I've been reading a

Speaker 12

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, on LIVALDEE, 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.

Speaker 2

Yes, absolutely Mark. This is Todd. I'll take that. We're not seeing any changes right now in federal funding for VIVITROL. I think it's just important to remember, over the last several years, we have totally re engineered the VIVITROL business with our focus on the AD indication.

Speaker 2

So we are really less reliant on government OD funding sources. So ideally though, the contribution of funding is really at the state level and at the state level, less than 5% of the VIVITROL demand is based on funding. So we're very well positioned overall. In terms of Livaldi, we continue to see healthy growth, as I said in my prepared remarks. Q1 year over year, we showed 22% growth in TRxs.

Speaker 2

We're not seeing any impact from any of the competitors in the marketplace right now. I think again, it's important to remember that Livaldi has a healthy mix of schizophrenia contribution plus bipolar contribution. In terms of cobemfi, HCPs continue to tell us that they're not making trade off decisions between Livaldi and Kobempi. If you look at the prescription data, you also look at market research, you'll see very clearly that the majority of Kobempi uses an adjunctive therapy. The mix of our business across the treatment paradigm is getting contributions from new patient starts, switch business plus add on business as well.

Speaker 2

So, we feel really good about the long term prospects of where Levalvy is.

Speaker 4

Thanks.

Operator

Our next question comes from Jason Gerberry with Bank of America. Please proceed with your question.

Speaker 10

Hey guys, thanks for taking my question. Appreciate all the updates on tariff stuff. So it sounds like the punch line here is everything from API to fill finish is going be sourced in The U. S. And never go through customs.

Speaker 10

And so if there's theoretical concerns around tariffing of transfer pricing, well, it sounds like you guys use like a royalty payment back to your Irish sub and any sort of transfer pricing tariff stuff like I don't know for that to have any impact. It seems like it's more of the realm of tax legislation. So just wanted to make sure folks understood that appropriately. And then, 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 narcolepsy type one population. I think you guys had indicated you'll do some added ophthalmic testing of some sort in these patients.

Speaker 10

I'm wondering if that'll be part of the early 3Q update as well. Thanks.

Speaker 3

Hi Jason, this is Blair. I'll take the first one. So just to clarify with regards to the products, yes, you're exactly right. We manufacture all of our products in The United States in Wilmington, Ohio. We do bring in some API from outside of The United States, but it is a very, very small amount of our total costs.

Speaker 3

So tariffs are really not a material impact to the business. I think as you look at transfer pricing and transfer pricing reform, we believe as you said that in order for them to do that, the administration that would require some sort of tax reform and involvement of legislation in Congress. And I think that takes time and it's very complicated. So what we're seeing the agency or the administration focus on right now are areas where they can do executive orders and that's the movement of goods across and through customs. And so we're monitoring everything very carefully, but we set our business up in a way that's quite flexible and we can adapt it to whatever comes downstream regardless of where they go.

Speaker 4

And then with regard to the question on Viprins one and visual exams, all patients in our phase two programs are receiving visual exams at baseline. We'll also be doing follow-up exams and to the extent patients have adverse events, we'll be testing and retesting those patients as well. As I said, we've got a data safety monitoring board, which has oversight over the totality of the safety of the study. As part of that panel, we've got an ophthalmologist built into that as well. And thus far, we've been given green lights on proceeding without any modifications across all of our studies.

Speaker 7

Got it. Thanks, guys.

Operator

Our next question comes from Leonid Timmiched with RBC Capital Markets. Please proceed with your question.

Speaker 13

Hey, guys. Thanks for taking my question. I had one on program. You mentioned in the prepared remarks that you're also thinking about orexins for cognition, attention. You know, I'm curious if you can gather any data on those endpoints in the ongoing Phase IIs or in the open label extension portions, if there's any formal endpoints you can evaluate there?

Speaker 13

And then I'm curious if any of those aspects can also potentially pull through into stimulating activity of orexins and if there's any potential for likeability and if you can test for that as well in the Phase IIs? Thanks.

Speaker 4

Yes, it's an interesting question. Obviously, a number of the different aspects that we're capturing in terms of the PROs and sleep quality and what have you will be we'll have a read through into a potential utility in other indications. In parallel, we've generated a wealth of preclinical data. We've got confidence that we're sort of refining which indications we're going to be prioritizing. First order of business for us is obviously to get the SAD and MAD studies completed for the two orexin agonists that we will be moving forward in these indications and then to get those initial proof of concept studies up and running and that will be informed by some of this work that we will have coming out of some of the PROs and what have you from Orexin program as well, narcolepsy studies.

Speaker 1

Just to be clear, there's a whole suite of PROs that we're investigating in the phase two study that won't be part of the first data readout, which are focused on MWT, Epworth and cataplexy. But we're testing a number of different PROs that touch on some of those domains that you referred to and we'll look for signal there and that will inform both our Phase three program as well as other indications.

Speaker 4

And then in terms of the human abuse potential studies, we're doing standard human abuse potential studies starting with our preclinical assessments and that will obviously then inform any additional work that needs to be done. So that's something that's going to be built into a standard into any neuroscience program.

Operator

Our next question comes from Yohai Eir with Mizuho Securities. Please proceed with your question.

Speaker 14

Hey, guys. Yeah, thanks for taking our questions. Given the upcoming data readout, maybe just help us set expectations for the VIBRANS one. Just wondering what in terms of efficacy are you expecting and safety? And if you're if not that, and maybe just remind us what was the effect size that was assumed for the phase two study in the powering?

Speaker 14

Thanks.

Speaker 1

Anyway, it's Rich, I'll just jump in on this because it's pretty simple. VIBRANCE one six week double blind phase is what we'll top line early in Q3 based on the timeline now. That'll be your primary efficacy analyses which will be MWT, Epworth and Cataplexy. And we'll give, because I think there's so much belief in the efficacy signal in NT1, I think a lot of focus will be on the tolerability and so we'll try to summarize the tolerability profile as extensively as we can for that dataset. Those data then will be followed in time by the seven week open label extension data where Craig had mentioned, we'll see the variability of the dosing, how patients can then choose the dose that they wanna go to, as well as these other patient reported outcomes that we're testing in phase two, along with the polysomnography that we'll pick up looking at sleep quality across the range of doses during the six week double blind period as well.

Speaker 1

Those will be subsequent data sets. The powering of this is not powered, the sample size is not powered based on efficacy calculations, powered based on interactions with FDA on safety exposures. So we expect to be highly powered for the efficacy endpoints, and we'll have a big enough sample size with long enough duration of exposure to really characterize tolerability.

Operator

Okay, thanks. Our next question comes from Joel Beatty with Baird. Please proceed with your question.

Speaker 7

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?

Speaker 2

Yes, absolutely. We feel the same VIVITROL had a really solid quarter, really primarily driven by alcohol dependence. In fact, alcohol dependence growth in Q1 was 10% faster than the overall alcohol dependence market. Our expectation is that will continue through this year. As we prepare for a competitive entrant in the outer years, our belief continues to be that this is not only a complex product to make, but a very complex market to product to commercialize.

Speaker 2

So, we don't believe that it will take a typical generic erosion curve and we're going to be prepared to drive demand and growth. If not, we're always flexible. We can modulate and flex our commercial infrastructure to make sure that we're driving profitability for the brand long term.

Speaker 13

Thank you.

Operator

Our next question comes from David Hung with Deutsche Bank. Please proceed with your question.

Speaker 7

Hi, there. Thanks so much for taking the questions. So I just wanted to ask, given the cadence of Phase two data that you'll get here in NT1, NT2 and IH, how you think about having timing of regulatory interactions with FDA around things such as end of 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 three and then eventually commercialization? Thanks so much.

Speaker 4

Yes, so the cadence that we plan to move forward with is to bring both NT1 and NT2 forward into an end of Phase two meeting with the agency and that's obviously something that the team can already start planning once we have NT1 data in hand. In terms of

Operator

How many doses?

Speaker 4

How many doses. So one of the strengths of our program is really the fact that we have a broad range of doses and a wide therapeutic index. So our intention is to bring multiple doses into the Phase III program. This is obviously going to be informed by the strength of our Phase II data and our interactions with regulators as we plan our Phase III program.

Operator

Maria, we'll take one more question, please. Okay. Our last question will be from Douglas Tsao with H. C. Wainwright.

Operator

Please proceed with your question.

Speaker 10

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 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 different sets of uses?

Speaker 4

At this point in time, we've made a lot of progress on our preclinical data since the R and D Day. In parallel, our second work stream is really to get these two agents into the clinic and to generate SADMAD data. And at that point in time, we'll be well positioned to disclose more in terms of which indications we've decided to move forward with. It's Rich, but

Speaker 1

also for sure, we see multiple drugs advancing in different therapeutic areas.

Speaker 10

And just as a follow-up, I'm curious, does the ultimate indication selection depend a little bit on the SADMAD data, meaning just given the sort of profiles that you see in terms of exposure, maybe some other pharmacological endpoints that you're looking at help you decide this molecule might be better suited for one indication versus the other?

Speaker 4

Yeah, absolutely. I mean, I think, while there are some similarities between the two RX and receptor agonists that we're moving forward, they have distinct pharmacokinetic and pharmacodynamic properties. We'll learn a whole lot more from SAT and MAD studies. And in parallel, we're generating a lot more preclinical data, and those two work streams together will help inform which agents are best matched to which indications.

Operator

We have reached the end of our question and answer session. I would now like to turn the floor back over to Sandy Coombs for closing comments. Great. Thanks, everyone, for joining us on the call this morning. Please don't hesitate to reach out to us at the company if you have any follow-up questions.

Operator

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Powered by Quartr
Earnings Conference Call
Alkermes Q1 2025
00:00 / 00:00