Alkermes Q2 2025 Earnings Call Transcript

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Provided by Quartr
July 29, 2025

Key Takeaways

  • Positive Sentiment: Q2 financial results beat expectations with total revenue of $390.7 M and proprietary net sales up 14% YOY to $307.2 M, driving GAAP net income of $87.1 M and adjusted EBITDA of $126.5 M.
  • Positive Sentiment: Phase II VIBRANCE-1 data for elixorextin (ALKS-2680) in narcolepsy type 1 showed statistically significant, dose-dependent improvements in wakefulness, cataplexy, fatigue and cognition with no new safety signals on hepatic or ophthalmic exams.
  • Positive Sentiment: Strong balance sheet position with over $1 billion in cash, zero debt and $200 million of share repurchase authorization provides significant strategic optionality.
  • Neutral Sentiment: Upcoming VIBRANCE-II (narcolepsy type 2) topline data expected this fall and VIBRANCE-III (idiopathic hypersomnia) data in mid-2026, alongside first-in-human studies for two other orexin-2 receptor agonists (ALKS 4510, ALKS 7290).
  • Negative Sentiment: R&D expenses rose to $77.4 M in Q2 (from $59.6 M a year ago) and are projected to increase further in H2 as multiple Phase II studies progress.
AI Generated. May Contain Errors.
Earnings Conference Call
Alkermes Q2 2025
00:00 / 00:00

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Operator

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

Sandy Coombs
Sandy Coombs
SVP - Corporate Affairs & IR at Alkermes

Good morning. Welcome to the Alkermes PLC conference call to discuss our financial results and business update for the quarter ended 06/30/2025. With me today are Richard Pops, our CEO Blair Jackson, our Chief Operating Officer Todd Nichols, our Chief Commercial Officer Doctor. Craig Hopkinson, our Chief Medical Officer and Doctor. Marcus Jons, Vice President of Clinical Development.

Sandy Coombs
Sandy Coombs
SVP - Corporate Affairs & IR at Alkermes

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. 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.

Sandy Coombs
Sandy Coombs
SVP - Corporate Affairs & IR at Alkermes

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. 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.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Thank you, Cindy, and good morning, everyone. We had a very successful second quarter. Our commercial and financial performance were strong. And last week, we took another major step forward in our pursuit of a medicine that has the potential to transform the treatment of narcolepsy. Now, midway through 2025, we're on track to deliver on our key objectives across the business.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

In commercial, we had planned for strong sequential growth, and we exceeded our expectations in the second quarter. This result was driven by excellent operational execution by a seasoned commercial team. With sustained profitability now, no debt, and more than $1,000,000,000 of cash, we are in a strong financial position with significant optionality. It's clear to us now that the future growth of the business can be accelerated by the development candidates now in our pipeline. Last week, we reported positive top line results from Vibrance one.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

This was our first phase two study of elixorextin, which you formerly known as ALKS2680, in narcolepsy type one. Vibrance one was successful and a critical study in the development of our orexin portfolio, obviously for the efficacy and safety data it yields, but also for the operational foundation it provides for the phase three program. Now, if you think back a year ago, we had data from our phase 1b study of elixorexin that suggested robust efficacy and a generally well tolerated profile based on single day exposures across a range of doses in small cohorts of patients with narcolepsy type one, narcolepsy type two, and idiopathic hypersomnia. These data were critical in defining the initial clinical profile and dosing range for elixirextin. This was step one.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Step two is to confirm and extend these observations in multi week, multi dose, phase two outpatient studies. Vibrance one in patients with narcolepsy type one is the first of these studies. Now, we have randomized, placebo controlled, six weeks, multi dose data in hand from more than 90 patients with NT1. We've now answered key questions in phase two with rigorous assays across larger cohorts of NT1 patients over a longer period of time. These data and insights will be fundamental in preparation for phase three.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

So, here are the key findings from the study at the top line. First, the results demonstrate a significant effect on wakefulness and a generally well tolerated profile. This was our pretest hypothesis, and the data were in line with our expectations. Second, the study provided entirely new and exciting findings relating to fatigue and cognition. These are among the most disruptive symptoms patients with narcolepsy experience, and they're distinct from excessive daytime sleepiness.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

In this study, elixirextin showed robust and clear improvements on validated patient reported measures. Our view is that demonstrating effects in these domains establishes a new standard in the development of REXN2 receptor agonists in narcolepsy. These emerging data also further support our hypothesis that the orexin system can be harnessed to address other neuropsychiatric and neurological conditions. We have two additional orexin candidates that we plan to develop for conditions beyond central order disorders of hypersalnolence. In Q2, we initiated first in human studies for one of these candidates, ALKS four thousand five hundred ten.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

We plan to advance the second candidate, ALKS seven thousand two hundred ninety, into the clinic later this year. So for today, Craig and Marcus will take you through the top line results of VIBRANCE-one, with significantly more detailed data to be presented at the upcoming World Sleep Meeting in September. But first, Blair and Todd will review the financial and commercial performance of the business for the second quarter. And with that, I'll hand the call over to Blair.

Blair Jackson
Blair Jackson
Executive VP & COO at Alkermes

Thank you, Rich. Our second quarter financial results were strong and reflected solid commercial and operational execution. We had planned for accelerated growth from the first quarter and we exceeded our expectations. Financially, the year is progressing nicely and we remain well positioned to achieve our financial guidance for the full year, which we reiterated this morning.

Blair Jackson
Blair Jackson
Executive VP & COO at Alkermes

For the second quarter, we generated total revenues of $390,700,000 For our portfolio of proprietary products, we generated net sales of $307,200,000 reflecting 14% year over year growth. These results were driven by strong underlying demand, which Todd will address in his remarks, and gross to net favorability, primarily related to Medicaid utilization rates and certain other credits during the quarter. These factors drove a one time gross to net benefit of approximately $9,000,000 for VIVITROL and approximately $11,000,000 for ARISTADA. Taken together, these gross to net dynamics resulted in a proprietary product revenue tailwind of approximately $20,000,000 in Q2. As we move into the third quarter, we expect Q3 net sales from this portfolio in the range of $280,000,000 to $300,000,000 Manufacturing and royalty revenues were $83,400,000 for the second quarter, including revenues of $39,400,000 from VUMERITY and $30,300,000 from the long acting INVEGA products.

Blair Jackson
Blair Jackson
Executive VP & COO at Alkermes

Turning to expenses, cost of goods sold were $49,500,000 which compared favorably to $61,500,000 for Q2 last year, primarily reflecting efficiencies following the sale of our Athlon based manufacturing business last year. R and D expenses were $77,400,000 compared to $59,600,000 for Q2 last year, reflecting investments in the Vibrance Phase two studies of elixorexant across narcolepsy and idiopathic hypersomnia. We expect R and D expense to step up slightly in the second half of the year as we complete our Phase two studies in narcolepsy and continue to build momentum in our Phase two study in idiopathic hypersomnia. SG and A expenses were $170,800,000 compared to $168,100,000 for Q2 last year. For trending purposes, we expect SG and A expense to be fairly consistent in Q3 and a modest decrease in the fourth quarter of the year.

Blair Jackson
Blair Jackson
Executive VP & COO at Alkermes

This performance generated strong profitability of GAAP net income of $87,100,000 EBITDA of $101,600,000 and adjusted EBITDA of $126,500,000 in the second quarter. Turning to our balance sheet, we ended the quarter in a strong financial position with $1,050,000,000 in cash and total investments. 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. As we look ahead, based on our performance during the first half of the year and the expected contribution from our expanded sales efforts, we are on track to deliver record revenues from our portfolio of proprietary products in 2025. As a result of this strong performance, we now anticipate finishing the year towards the higher end of our previously issued financial expectations in terms of both revenue and profitability. With that, I'll turn the call to Todd for a review of the proprietary portfolio.

Todd Nichols
Todd Nichols
SVP & Chief Commercial Officer at Alkermes

Thank you, Blair, good morning everyone. In the second quarter, we recorded net sales from our proprietary product portfolio of $307,200,000 reflecting 14% year over year growth. We drove strong end market demand across VIVITROL, ARISTADA and LYBALBI by executing targeted growth initiatives and delivered strong sequential growth from Q1 to Q2. Due to this demand growth and the gross to net favorability during the quarter that Blair outlined, our second quarter proprietary net sales of $307,200,000 exceeded the expectations that we provided in May of net sales in the range of $260,000,000 to $280,000,000 Starting with VIVITROL, net sales in the second quarter were $121,700,000 VIVITROL performance continues to be driven by growth in the alcohol dependence indication market and our ability to capitalize on highly localized market dynamics in certain states and payer systems. Looking ahead, we continue to expect VIVITROL net sales for the full year 2025 in the range of $440,000,000 to $460,000,000 Turning to our psychiatry franchise.

Todd Nichols
Todd Nichols
SVP & Chief Commercial Officer at Alkermes

Expansion of our psychiatry sales force completed earlier this year was an important element of our strategy to maintain a competitive share of voice for LYBALVY and reaccelerate growth for ARISTADA. The early returns from that expansion are encouraging and we are pleased with our progress to date. For the ARISTADA product family, in the second quarter net sales were $101,300,000 Leading indicators related to underlying demand were encouraging with increased prescriber breadth and strong new to brand prescriptions during the quarter. For the full year 2025, we continue to expect ARISTADA net sales in the range of $335,000,000 to $355,000,000 Turning to LYBALDI, Net sales grew 18% year over year to $84,300,000 Underlying TRx growth was 22% year over year, driven by new patient starts and prescriber breadth. Gross to net adjustments were approximately 29% in the second quarter.

Todd Nichols
Todd Nichols
SVP & Chief Commercial Officer at Alkermes

We now expect gross to net adjustments for the full year will be approximately 30%. For the full year, we continue to expect LEVOLVE net sales in the range of $320,000,000 to $340,000,000 Across the portfolio, we are pleased with our second quarter performance and are focused on maintaining this momentum and driving demand in the second half of the year. With that, I will pass the call to Craig.

Craig Hopkinson
Craig Hopkinson
EVP, R&D and Chief Medical Officer at Alkermes

Thank you, Todd. Last week we announced positive top line results from the Vibrance one Phase two study of elixorexant in patients with narcolepsy type one. The data further characterized the clinical profile of elixorexant and demonstrated that once daily elixorextone normalized wakefulness and excessive daytime sleepiness scores in highly symptomatic patients with narcolepsy type one with a generally well tolerated profile across all doses tested. These top line results represent the first of a series of data sets that will emerge from the elixorexant Phase II program. The data are extensive and break new ground.

Craig Hopkinson
Craig Hopkinson
EVP, R&D and Chief Medical Officer at Alkermes

We are looking forward to presenting the primary and key secondary endpoints related to wakefulness and cataplexy and the safety and tolerability profile observed in the six week double blind period of the study in an oral presentation at the upcoming World Sleep Meeting at the September. In addition to the top line results, we'll also share data relating to the exploratory patient reported outcomes collected in Vibrance one, including the fatigue and cognition data outlined in our top line press release last week. These data are truly exciting, not only in terms of the clinical profile for elixirrhexidine, but also as we plan for additional clinical studies across our portfolio of investigational orexin-two receptor agonists in disorders where impaired cognitive functioning and fatigue are key clinical features. Following World Sleep, we expect top line results from Vibrance II, our Phase II study in narcolepsy type two in the fall. Enrollment in Vibrance two is going well and we expect to complete that soon.

Craig Hopkinson
Craig Hopkinson
EVP, R&D and Chief Medical Officer at Alkermes

Top line data from Vibrance three, our Phase two study in idiopathic hypersomnia, are expected to follow in mid-twenty twenty six. Each of these studies provides a significant amount of data to analyze and will deepen our understanding of elixirixa's potential utility across central disorders of hypersomnolence and its differentiating features in the competitive landscape. In parallel, we are preparing for key regulatory interactions and for the global Phase three program in narcolepsy that we plan to initiate as rapidly as possible following the top line data from the narcolepsy type two study. Alchemist is at the forefront of development in this exciting potential therapeutic category, and the positive Vibrance one data represents an important stride forward for elixorexin development program and our broader portfolio of orexin-two receptor agonists. With that, I'd like to introduce Doctor.

Craig Hopkinson
Craig Hopkinson
EVP, R&D and Chief Medical Officer at Alkermes

Marcus Jamps to review the top line data from the Vibrance-one study. Marcus is Vice President of Clinical Development and the Clinical Program Lead for Elixorexin here at Alchemys. Marcus?

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

Thank you Craig. Vibrance one is a six week double blind placebo controlled parallel design study evaluating three different doses of elixorextin in patients with narcolepsy type one or NT1. The study enrolled a total of ninety two patients, with most having moderate to severe disease at baseline. Patients were randomized to one of three once daily dose levels of elixirextin four, six, or eight milligrams, or placebo. The primary endpoint of Vibrance one was the change from baseline compared to placebo in the Maintenance of Wakefulness Test, or MWT.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

MWT is a standardized quantitative measure of how long patients can stay awake during a forty minute test period when they are in an environment that is conducive to sleep. These tests are conducted at two, four, six, and eight hours post dose. The mean score is calculated by averaging the results of these four tests. While the MWT is less frequently used in real world clinical settings, it is an important objective endpoint commonly used for regulatory purposes. In Vibrance one, elixorexin showed dose dependent, statistically significant, and clinically meaningful increases in mean sleep latency at all doses tested at week six.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

Importantly, all dose groups achieved normative wakefulness, applying the standard convention of a mean sleep latency on the MWT of twenty minutes or more. The study also evaluated key secondary endpoints, including change from baseline on the Epworth Sleepiness Scale and weekly cataplexy rates compared to placebo. First, the Epworth Sleepiness Scale, or ESS. Unlike the MWT, this scale is widely used in the clinic as a diagnostic tool to assess for excessive daytime sleepiness. The ESS is a patient reported symptom questionnaire asking about the patient's likelihood of falling asleep across eight different scenarios, such as watching TV, riding in a car, or reading a book over the last week.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

Higher scores indicate a greater likelihood of falling asleep, with a score of 10 and below considered normal. The Epworth Scale is useful in that the seven day look back period provides a holistic view of patient's sleepiness beyond the eight hour MWT test period. Here, across all doses tested, elixorextin demonstrated statistically significant and clinically meaningful improvement at week six, with each dose group achieving normative levels. In addition to excessive daytime sleepiness, NT1 patients can experience a sudden involuntary loss of muscle tone, called cataplexy. Vibrance one evaluated mean weekly cataplexy rates.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

To measure this endpoint, patients are asked to keep diaries of cataplexy events that they experience. The average number of weekly events across weeks five and six in the elixorextin treated subjects were then compared to those experienced by the placebo group. Across all doses tested, elixorextin showed numerical and clinically meaningful improvements in cataplexy compared with placebo and, on the pre specified analysis, met the threshold for statistical significance at the six mg dose. We are confident in the effects of elixiraxin on cataplexy and believe there are learnings here related to our implementation of this assay that we will apply in Phase III to reduce variability and the impact of outliers. We look forward to sharing additional analyses of these data at World Sleep.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

So while excessive daytime sleepiness is the hallmark symptom of narcolepsy, many patients also experience other symptoms such as fatigue and cognitive dysfunction. These can result in significant morbidity as well as impaired quality of life. Our hypothesis has been, given the nature of the neurocircuitry affected, that elixirextin could have an impact on many of the aspects of this disease that affect patients' day to day functioning. The British Columbia Cognitive Complaints Inventory, or BCCI, and the PROMIS Fatigue Scales capture two of these common and often debilitating effects of narcolepsy. The BCCI evaluates concentration, memory, expressing thoughts, word finding, slow thinking and difficulty solving problems.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

The PROMISE Fatigue measures patients frequency as well as intensity of fatigue, along with its impact on physical, mental and social activities. It is important to note here that fatigue is a symptom that patients experience, which is distinct from sleepiness. While sleepiness is a general feeling of being tired and wanting to sleep, fatigue is a broader feeling of exhaustion that can be long lasting and may not be resolved by sleep. We also looked at the narcolepsy severity scale. The NSS captures a holistic assessment of disease by evaluating five key narcolepsy symptoms: excessive daytime sleepiness, cataplexy, hallucinations, sleep paralysis, and disturbed nighttime sleep.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

And on each of these exploratory patient reported outcome scales, the BCCI, the PROMIS fatigue, and the NSS, Elixorexin demonstrated clinically meaningful improvements from baseline compared to placebo that were statistically significant. Of course, the p values here are nominal due to the exploratory nature of these endpoints. So from a clinical perspective, these results are compelling due to the robustness and particularly the consistency across all doses of Elixorexin as well as across various complementary assays. This is the first time that we've seen data from the Erexin class on these fatigue and cognition scales and we believe this differentiates Elixorexin from other development programs and builds upon the evidence base that orexin-two receptor agonists with appropriate pharmaceutical properties could have broad potential utility across a range of neurological or neuropsychiatric disorders. And now we'll turn to safety and tolerability.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

Overall, elixorextin was generally well tolerated in this study. The majority of the treatment emergent adverse events were mild to moderate in severity, and no treatment emergent serious adverse events were seen. The TEAEs that did occur were generally consistent with the events that we observed across the phase one studies in healthy volunteers and in subjects with NT1, NT2 and IH. And among the many clinical safety assessments we conducted in the study, two of particular interest are hepatic labs and ophthalmic exams. And importantly, there were no treatment emergent safety signals seen in these assessments.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

So overall, we are very pleased with the safety and efficacy profile thus far and we look forward to presenting these datasets at World Sleep. I'll hand it back to you, Rich.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Well done. Thank you, Marcus. So that's a summary of the top line findings. There's a lot more to come, and you'll begin to see it in a few weeks at World Sleep. These data in NT1 represent a meaningful step forward for elixirextin development program, and they provide a substantial new dataset that significantly expands our understanding of orexin biology, not just relevant in narcolepsy, but its potential across a broad range of neuropsychiatric and neurological disorders.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

We're now moving forward with confidence and a sense of urgency as we prepare for the initiation of our registrational program in narcolepsy. And with clear findings now relating to cognition and fatigue, adding to what we've seen for excessive daytime sleepiness, we now have further data supporting development of additional orexin candidates in other disease states beyond sleep disorders. As you've heard throughout this call, the business is in a strong position. Our commercial team is on track to deliver proprietary product next sales in excess of $1,000,000,000 and robust profitability in 2025. Our balance sheet is strong and provides strategic optionality with more than $1,000,000,000 in cash.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Our pipeline products are advancing. Elixorexin is the first major potential commercial opportunity to emerge from our orexin portfolio. But we also believe that sleep disorders are just the beginning for this exciting new therapeutic category. So thank you for your patience. With that, I'll turn the call back to Sandy to run the Q and A.

Sandy Coombs
Sandy Coombs
SVP - Corporate Affairs & IR at Alkermes

Great. Thanks, Rich. Rob, we'll now open the call for Q and A, please.

Operator

Thank you, Sandy. We'll now be conducting a question and answer session. Session. Thank you. And our first question today comes from the line of Paul Matteis with Stifel. Please proceed with your question.

Paul Matteis
Paul Matteis
Managing Director, Head of Therapeutics Research at Stifel Financial Corp

Hey, good morning. Thanks so much for taking my question and congratulations on all the progress. I don't want to front run the World Sleep presentation and ask a specific data question, but taking a step back, there's been a lot of focus right or wrong from Wall Street on visual adverse events with the Orexin program. And I guess I wanted to ask the Alkermes team, one, do you think the focus on visual AEs is warranted? Like, we on the right track and kind of thinking about whether this is clinically significant?

Paul Matteis
Paul Matteis
Managing Director, Head of Therapeutics Research at Stifel Financial Corp

And then two, where would you draw the line on a visual AE signal that is benign and might not have much regulatory commercial consequence versus something that might be more significant and you know, might require certain things like driving studies or could result in certain restrictions on a drug label? Thanks so much.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Good morning Paul. Hey, let me start and then I'll hand it over to experts. I can just tell you, in my experience dealing both with clinicians and investigators and patient groups and dealing with Wall Street, the focus is almost entirely on the Wall Street side, on the visual AEs. And it's an important contribution that we made in this particular study because as I've said before, there was a reasonable scientific medical question at the beginning of this program about whether a REXN2 receptor agonist can have a direct effect on the eye. So with this rigorous baseline ophthalmic exam at baseline and then six weeks later having 90 plus patients worth of data to establish now that we saw no changes was an important step forward in that.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

But I think from a clinical perspective, I'll let these guys comment on that and what their experience has been. But we won't provide any more specific AE data on this call other than what's in the press release, but I think they can give you some qualitative sense of it.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

Yeah, exactly. As Rich pointed out, we're not providing additional AE data, but I think in general we do feel that based on some of our discussions that any AE that's thought to be mild and not interfering with patients' daily activity, is not going to be something that's going to be overly concerning both for physicians or for their patients.

Craig Hopkinson
Craig Hopkinson
EVP, R&D and Chief Medical Officer at Alkermes

Yeah, and maybe just to add to that, we had a data safety monitoring board in place, overseeing all safety from the Vibrance program and they've met a number of times and given us the green light to proceed. In addition to that, as Richard has pointed out, the ophthalmologic exams were normal, we established baseline, so that gives us some confidence there as well. And then sort of directionally as we've sort of said in our disclosure, the adverse event profile is in line with what we saw across the Phase one healthy volunteer and patient cohorts from that Phase one program.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Hey Paul, let me just add it because it might anticipate some other questions that we're going to get. Just as a matter of fact, the safety database is actually not even closed until probably mid August because recall we have a seven week extension that follows the six week double blind. So actually, we couldn't populate data tables with specific numbers until that database is locked. Part of the reason for the level of disclosure at the top line was simply to characterize accurately what we found in the six week double blind period. We'll actually have very specific data for you by the time we come into World Sleep in September.

Paul Matteis
Paul Matteis
Managing Director, Head of Therapeutics Research at Stifel Financial Corp

Great. Thanks for all the perspective.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

You're welcome.

Operator

Our next question is from the line of Akash Tewari with Jefferies. Please proceed with your question.

Anastasia Parafestas
Anastasia Parafestas
Equity Research Associate at Jefferies

Thanks so much for the question. This is Anastasia on for Akash. So in Phase II, it looked like TAC-eight sixty one may have left some efficacy on the table in MWT versus September. How confident are you that 2680 may be able to fully explore that exposure response range between four and eight mg in NT1 and differentiate on efficacy versus Takeda?

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Yeah, we've always thought that a range of doses would be a competitive advantage. And, you know, I'm not going to comment on the competitive programs. I think that one of the features of this program has always been the ability to dose across a wide range, in NT1 leading into NT2 and IH as well. So we'll wait to see the data from the NT2 and IH cohorts, but we're very pleased with the dose range that we selected for this NT1 study.

Operator

Thank you. The next question is from the line of Andrea Newkirk with Goldman Sachs. Please proceed with your question.

Andrea Newkirk
Andrea Newkirk
Biotechnolgy Equity Research at Goldman Sachs

Good morning. Thanks for taking the question. Rich, was just wondering if you might be willing to speak a little bit about how you're thinking about the regulatory path from here, recognizing you do still need to meet with the FDA, but is there the possibility that these Vibrant studies could serve as registrational trials? And if not, would you expect one registration enabling trial per indication would be sufficient to support approval or would you need two for each?

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Good morning, Andrea. Thank you for the question. Yeah, I think, okay, the first stipulation will be that FDA is a fairly fluid place right now. But I'm going answer the question based on what we know coming into things. And that is that our expectation was to complete the NT2 study and because we'll be seeking a label that encompasses narcolepsy writ large, which would encompass NT1 and NT2, we would wait for those data from NT2 before scheduling our formal end of phase two meeting with FDA.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Where we'll agree on the phase three design. The reason we're doing that is because we're currently the only player in NT2 at this late stage and so that's a very differentiating part of the product and potentially the label. And as we understand the NT2 doses relative to NT1 doses, then we'll have the ability to sit down with the FDA and map out the phase three program. Our assumption right now is that our phase three program will look very similar to the competitors, I. E.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Three month study in NT1 and probably a similar study in NT2. One each, but we would confirm that in our end of phase two meeting.

Andrea Newkirk
Andrea Newkirk
Biotechnolgy Equity Research at Goldman Sachs

Okay, thank you.

Operator

The next question is from the line of Umar Raffat with Evercore ISI. Please proceed with your question.

Umer Raffat
Senior Managing Director at Evercore ISI

Hi, guys. Thanks for taking my question. Just two quick ones. One, could you confirm the dose response is in fact linear on MWT? And I ask because there's been some questions around the cataplexy observation, and my question is, I realize there's a numerical trend, but it's not stat sig at eight milligrams.

Umer Raffat
Senior Managing Director at Evercore ISI

Is it reasonable to assume, based on how the data and the variability looked, that you guys tripped the threshold on Poisson and ended up using negative binomial distribution to drive the p value? Did that explain partially why p value was broader for eight milligrams? Thank you.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Morning, Umer. It's Rich. We haven't talked anything specifically about the linearity or lack thereof of the dose response. You'll actually see all the by dose information in just a few weeks' time at World Sleep. Your statistical question on cataplexy is impossible for me to answer, so I'll pass it to the pros.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

Sure, yes, I can answer that. So we did use the negative binomial analysis and that was actually pre specified for us in conjunction with discussions with the FDA. So we did use that analysis and pre specified, and based on our data, that was the appropriate analysis to use.

Umer Raffat
Senior Managing Director at Evercore ISI

Tim, can I just clarify then, Poisson was not your base case? It went it went straight into negative binomial?

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

That's correct.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

That's correct. Yep.

Umer Raffat
Senior Managing Director at Evercore ISI

Wouldn't that create a discrepancy when we look at p values for Takeda dataset versus ALKEMY dataset? There wouldn't be apples to apples on p value basis?

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

It's a good question. I mean, we're not comparing apples to apples directly with their data set regardless. Obviously, they were different patient populations, so we wouldn't compare across trials directly. But this is the analysis that we used in a pre specified manner.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

And I would say that's one statistic that you use as a lens to look at the data. When you go to World Sleep, you'll see other perspectives on that data that I think very clearly show elixirexan's effect on cataplexy at these doses. So for us, we think of it as more of a methodological learning for phase three. Which statistic and which method are we going to apply in phase three, recognizing we see a very clear cataplexy signal.

Umer Raffat
Senior Managing Director at Evercore ISI

Got it. And, Richard, I'm sorry. I since this is so important, I just wanna be clear. Numerical trend wise, you think the data is as competitive as Takeda on cataplexy?

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Well, I again, it's apples and oranges. So you can make the decision yourself when you see the data itself, but I think we feel quite comfortable that we have a clear cataplexy signal that you'll see. There's some outlier data that really confuses the statistic, So you can try to correct for that using various statistical methods, or you can just look at the data and you'll see the data more complete revelation at World Sleep, and I think we can talk about that afterwards, but think you'd be satisfied that we have a very clear signal on cataplexy. Just as an aside, without mass associated with it, remember the narcolepsy severity scale picks up cataplexy as one of its key domains, and we've normalized patients on the NSS. So all the data tended to to to work complementary.

Umer Raffat
Senior Managing Director at Evercore ISI

Thank you.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

You're welcome.

Operator

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

Adam Ferrari
Adam Ferrari
Biotech Equity Research Associate at J.P. Morgan

Hello, this is Adam on for Jess. Thank you for taking our question. I just wanted to ask, me, elixirrhexotins, could you please remind us of the potency selectivity towards the 0x2R over the 0x1R? Thank you.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Adam, I thought you were going ask how to pronounce elixirrhexin because it's not the easiest word to pronounce.

Craig Hopkinson
Craig Hopkinson
EVP, R&D and Chief Medical Officer at Alkermes

It's 5,000 fold.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

So, it's 5,000 fold more selective.

Adam Ferrari
Adam Ferrari
Biotech Equity Research Associate at J.P. Morgan

Great. Thank you.

Operator

Our next question is from the line of Joseph Thome with TD Cowen. Please proceed with your question.

Joseph Thome
Managing Director, Senior Biotechnology Analyst at TD Cowen

Hi there. Good morning. Congrats on the progress and thank you for taking my question. Maybe when we do look at the full safety profile of Alexarexin, maybe how much of that can be extrapolated to some of your follow on compounds four thousand five hundred ten and seven thousand two hundred ninety? It looks like there's obviously some Class Aurexin side effects that we're seeing, but is there anything different about the targeting or the dosing of four thousand five hundred ten, seven thousand two hundred ninety that you think could result in a different AE profile?

Joseph Thome
Managing Director, Senior Biotechnology Analyst at TD Cowen

Or I guess how much will the elixirrhexin initial data derisk follow on? Obviously, need to see the data, but how are you thinking about translatability there?

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Go ahead, Maurice.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

We think, yes, they are working on the same receptor, so we do think there will be some similarities. That being said, molecules were purposely developed to have different pharmacokinetic profiles and different structures that could lead them to not all look exactly the same on a profile. So of course, the human data will answer that question for us completely and we hope to have that for you in the near future on both 4510 and 07/1980.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

And Joe, if you don't mind, let me build on your question because we anticipate questions we've been getting from investors and that is how do the NT1 data anticipate what we've seen in NT2? And I think, I just want to make clear our original hypothesis which has been confirmed by our own data which is we believe that there's actually a frame shift in terms of the tolerability sensitivity to orexin agonist as you move from NT1 to NT2. Meaning, you'll need higher doses to drive efficacy and you'll need higher doses to drive the on target side effects as well. So we imagine just the dose response curve shifting to the right in that. And that's what is consistent with the data we saw in our phase 1b study.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

We'll know more definitively, obviously, when we get those data, but that's the pretest hypothesis.

Joseph Thome
Managing Director, Senior Biotechnology Analyst at TD Cowen

Perfect. Thank you.

Operator

The next question is from the line of Ayer with Mizuho Securities. Please proceed with your question.

Uy Ear
Uy Ear
Vice President at Mizuho Financial Group

Hey, guys. Yeah. Thanks for taking our question. Given that the NT two study, I guess the primary endpoint is complete, expects to complete in August. Just wondering, is there a good chance that you'll also present the NT2 data at World Sleep? Thanks.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Well, just to be clear, so we should complete enrollment in the next couple weeks, which then with a two month primary analysis puts us into the fall. So there won't be any NT two data at World Sleep. There'll be plenty of NT one to to review, so you you won't you won't be hungry.

Uy Ear
Uy Ear
Vice President at Mizuho Financial Group

Thanks.

Operator

The next questions are from the line of David Ensalen with Piper Sandler. Please proceed with your question.

David Amsellem
David Amsellem
Senior Research Analyst at Piper Sandler Companies

Hey, thanks. So number one, are you planning to build in dosing flexibility or any sort of titration in the Phase III as a means of minimizing treatment emergent adverse events? And then secondly, this is a commercial question. It's not of course unheard of to have a wakefulness promoting agent that does not have cataplexy in the label. I guess my question here is just given the wakefulness promoting properties of elixirrextone, how important is it to have cataplexy in the label in terms of a commercial adoption perspective? Thank you.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

So, good morning David. I'll give you my view and then I'll hand it over to the guys. We haven't made the call yet on the phase three dosing because we haven't finished all the analyses and we also want to see the NT2 dosing data before we decide on the range of doses. So, stay tuned there. What's so exciting about running phase two's of this quality is that now we have 92 patients worth of data to model.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

And our view is that that level of exposure time is essential for actually making those dosimetry decisions for the registrational program. So stay tuned on that. Wakefulness study, my own view, and Todd can answer the question, that believe Lexorexin is going to have a cataplexy claim in the label because the signal is quite clear. So it's more a matter of tuning the assay to make sure that we can see that in the data. But Todd, you can comment on whether you think cataplexy is an important part of presentation.

Todd Nichols
Todd Nichols
SVP & Chief Commercial Officer at Alkermes

No, I agree. I think you captured it right.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Okay.

David Amsellem
David Amsellem
Senior Research Analyst at Piper Sandler Companies

All right, thanks.

Operator

The next question is from the line of David Hong with Deutsche Bank. Please proceed with your question.

David Hoang
David Hoang
Director, Senior Analyst, Biotechnology at Deutsche Bank

Hi, congrats on the quarter and taking my question. So I just wanted to ask about the upper dose in the NT2 and IH studies. I believe it's eighteen milligrams. Could you just remind us how you landed on 18, specifically given '25 was used in earlier Phase 1b? And what would be I guess the ideal number to take forward into Phase three? Thank you.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Greg, you want to take that?

Craig Hopkinson
Craig Hopkinson
EVP, R&D and Chief Medical Officer at Alkermes

Yes. So we employed some sophisticated modeling, basically taking into account all the data that we had collected from our healthy volunteer studies as well as our Phase 1b program and ultimately modeled out the doses for Phase two. And and that's how we came to the dose selection.

Operator

Thank you. The next question is from the line of Ami Favia with Needham and Company. Please proceed with your question.

Ami Fadia
Senior Analyst at Needham & Company

Good morning. Thanks for taking my question. Going back to the focus on visual AEs, can you give us sort of your high level view on how important is it to avoid a dose that might have such an AE even if it were to be transient? And would you choose to take a dose into Phase III that might have seen a transient visual assets event? And just separately speaking, do you think that that is an on target effect of this class?

Ami Fadia
Senior Analyst at Needham & Company

And, you know, as you think about sort of your next gen assets, do you think that it's just a broadly target effect or is it more specific to the structure of a given drug? Thank you.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Me start out, Ami. I'm just going to try to pull you back up from the visual AE obsession to the AEs in general. I mean, what we're looking at in this data set is doses where we know there are on target AEs, namely insomnia and polyuria, that we and others have observed as on target effects that could be, that would limit your dose. So I think the virtue of this program is we've run three different doses for six week periods of time in the outpatient setting, and we'll get a complete time course as well as severity map of those AEs. And we have so much more data to look at together because let's say for example, if you have a numerical AE, did it happen every day over the forty two doses or did it happen once in the first week and then went away?

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

There's a lot of nuance to this. So I don't think it's easy to answer the question about what doses we would take forward because I think that there's a range of different AEs that we're going to be focusing on. And we think our competitive advantage is going to be this range of doses. Because not all patients are the same and people react to different doses. And I think that that would be true for efficacy as well as for AEs. Marcus, I'm happy get your view on it.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

Yes, yeah, I would agree. We're, as we speak, doing complicated modeling on exposure response, exposure safety analyses, and that's going to encompass everything we've seen. We're looking at this data in every way we can to help us determine what the best range of doses is going to be to move forward into Phase III. So that's going to encompass efficacy, it's going to encompass safety, and, you know, even ease of ease of dosing. And so we're thinking about all, possible criteria when we think about dosing moving forward.

Ami Fadia
Senior Analyst at Needham & Company

Thank you.

Operator

The next question is from the line of Ash Varma with UBS. Please proceed with your question.

Ashwani Verma
Ashwani Verma
Executive Director - SMID Biotech & Biopharma at UBS Group

Hi. Thanks for taking my question. So just on these, like, phase two studies, like, what time of the day are patients those with two six eighty? I understand it's down in the outpatient setting, except for the MWT days, but just what what's your direction to the patients? And then secondly, on the visual disturbance that you mentioned to you, so the PR says that you're not seeing any signal, but is that statement based on AEs that you may have seen in and outside of the scheduled exams? Thanks.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

Sure, I can answer the first part. So we tell them generally to take it in the morning, so roughly around 8AM. There's of course a window around that just to accommodate for various lifestyles, but roughly 8AM in the morning is when we ask them to dose.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

And we didn't delay any specific AE table elements I'm sorry, the phase two safety databases close in mid August. So you'll see those data at World Sleep in September.

Operator

Thank you. The next question is from the line of Leonid Timoshev with RBC Capital Markets. Please proceed with your question.

Leonid Timashev
Leonid Timashev
Biotechnology Analyst at RBC Capital Markets

Thanks, guys. I just want to ask on the endpoints. Just given what you've seen out of Vibrance one, are you still thinking that MWT is the best way to go forward compared to ESS and then both for any as you think about, I guess, the dual design for Vibrance II and then the ESS focus for Vibrance III. And then related to that, given all the secondaries that you hit on, including some of the exploratory, how are you thinking about elevating some of those exploratory endpoints to secondaries or key secondaries for a Phase III program like cognition or fatigue? And would you try to aim to get those on the label?

Craig Hopkinson
Craig Hopkinson
EVP, R&D and Chief Medical Officer at Alkermes

Thank you, guys. So from our perspective, we believe both MWT and Epworth are really important measures. MWT obviously, the more objective measure Epworth really sort of expressing the patients sort of subjective assessment. The reason that we elevated Epworth to a dual primary in the NT2 study is because of our sort of thought process around planning for regulatory interactions, really taking a look at the late stage clinical trial landscape and planning for our Phase three program. So yes, we believe both are important and I think the data from the NT2 study will help us plan then for our Phase three program with the dual primary endpoints.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

And on the key secondaries, Marcus, might want to comment on, but from my perspective, these were really exploratory. Some of these scales I don't think have been used in narcolepsy studies at all. And so we were curious to see whether we would see movement. And boy did we, I mean we really saw clear signals and you'll see more of those data at World Sleep. Given the magnitude of the response and how clear it was, I think we have to do a lot of thinking now about how we might elevate those in the hierarchy. Please comment on it.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

Exactly right, Rich. The team's here working diligently to look at exactly that, all of these various exploratory outcomes, the ones where we succeeded that again were hypotheses that we've now shown significant data on. And so the team is really working on how do we pull these in through the phase three and elevate them into the key secondary realm, in a way that allows us to really test the aspects of this drug, more thoroughly.

Operator

Thank you. The next question comes from the line of Jason Gerberry with Bank of America. Please proceed with your question.

Jason Gerberry
Jason Gerberry
MD & Equity Research Analyst - Biotech & Pharma at Bank of America Merrill Lynch

Hey guys, good morning, thanks for taking my question. So maybe just wanted to probe a little bit just your understanding of the relationship of PK and the weekly cataplexy endpoint, and whether or not you feel comfortable enough to rule out QD versus BID approaches conferring, you know, any advantage in terms of the WCR measurement. And then also just I know you're not commenting on Phase III dosing plans yet, wanting to see the NT2 results first. But I'm wondering if we can take from your comments that at least in the context of NT1 that there's at least enough confidence in the tox profile of the high eight mg dose that you could potentially push dose in future NT1 pivotal? Thanks.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Hey, you guys want to talk about PKWCR relationship?

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

Sure. I mean, at this point, those analyses are ongoing. So we've reported, as you know, sort of the top line results and we're really digging deeper into the PK, again, I mentioned, sort of exposure response, exposure safety. That's gonna be coming soon and potentially something you'll see in the future.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

But is it fair to say, Mark, I don't think there's a QD versus BID difference that we think is meaningful?

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

We don't, no, that's right.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

And with respect to the phase three dosing plans, I mean

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

Yeah, I mean at this point for phase three dosing, again, we're still making those determinations, so it's hard to speak to them. We do have confidence fully in our tox profile at eight milligrams, so there's no concern there, And we're obviously taking that into account as well as everything else we've talked about to determine our phase three doses.

Jason Gerberry
Jason Gerberry
MD & Equity Research Analyst - Biotech & Pharma at Bank of America Merrill Lynch

Got it, thank you.

Operator

The next question is from the line of Lou Kerman with Baird. Please proceed with your question.

Sandy Coombs
Sandy Coombs
SVP - Corporate Affairs & IR at Alkermes

Luke, do we have you?

Luke Herrmann
Research Analyst at Baird

Sorry, was on mute. Sorry, just a quick one for me. It looks like some nice step ups in revenues across the board. Can you just talk about the relative contribution from inventory or seasonal dynamics as compared to underlying demand for the commercial portfolio? Thank you.

Blair Jackson
Blair Jackson
Executive VP & COO at Alkermes

Yes, this is Blair. I'll start with on the number basis and I'll turn it over to Todd to get into some detail. I think number one, as you look at our proprietary programs, we saw demand increase across all three programs over the time period. We actually didn't have any inventory dynamics that contributed to this quarter. And so this is in line with normal seasonal dynamics and a contribution of our strong commercial performance. Todd, anything you want to add?

Todd Nichols
Todd Nichols
SVP & Chief Commercial Officer at Alkermes

Yes, would just agree with what Blair said. We saw strong demand for all three products, ARISTADA, VIVITROL and LIVALVI and we were really pleased with Q2 was really the step up in new patient starts. As we said earlier, exceed our expectations to Blair's point. Nothing to look at with inventory, inventories is growing with demand right now. So we're pleased with that.

Luke Herrmann
Research Analyst at Baird

Great. Thank you.

Operator

Thank you. Our last question comes from the line of Mark Goodman with Leerink Partners. Please proceed with your question.

Marc Goodman
Senior MD - Neuroscience at Leerink Partners

Yeah. Just back on this cataplexy endpoint discussion. Like, when you talked about the learnings for the phase three, are these learnings basically just the statistical methods that you were talking about, or are you talking about using different assays? I'm I'm a little confused. Maybe you can shine a little more light there.

Marc Goodman
Senior MD - Neuroscience at Leerink Partners

I mean, we're we're we're all still a little confused what happened with the cataplexy data, and we're wondering, like, are we even gonna learn like like, once we once we see the data in Singapore, we're gonna feel much better about it. I mean, because you were talking about statistical significance of what needs to get on the label. Like, doesn't it need to be stat sick to get on the label? I mean, this is a pretty important part of the story. Right?

Marc Goodman
Senior MD - Neuroscience at Leerink Partners

So maybe you could just give us a flavor for that. And then just since on the last question, I'll ask as well. The working assumption is that insomnia is only seen at the very beginning, so should we still have that assumption that, you know, any type of insomnia is still only seen in week one? Thanks.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

Go ahead, Marcus, the on the cataplexy. Let's clear that up because it's important, and I think we have a really clear picture of this, Mark.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

Sure, do. We do think the cataplexy results had a lot of what we saw likely had to do with outliers that we saw in the Vibrance one study. And we think some of that could have to do with the operational implementation of the assay.

Marcus Yountz
Marcus Yountz
VP - Clinical Development at Alkermes

So particularly things like standardization of how patients are recording cataplexy at sites and even across sites and what is a global study. So these are the types of things that for Phase three we're going to apply in attempts to reduce this variability and minimize any outliers that we might see.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

And to your point, of course, you'll need to see statistically significant results for an inclusion in the label. And that would be our objective. And when you see the data at World Sleep, you can draw your own conclusions about the strength of the signal on cataplexy. We shouldn't be surprising given all these other endpoints are moving so strongly toward normal. You wouldn't expect to see a whole lot of discordant data in a cataplexy.

Richard Pops
Richard Pops
Chairman & CEO at Alkermes

But the statistic itself, as you saw in the top line release, significant at one dose and not at the other two doses, I think you'll get a little bit more understanding about why that might have happened when you see the variability. And we, know, we're not gonna comment on the time course of of of the various AEs. You'll see you'll see more of that at growth sleep as well.

Operator

Thank you. At this time, we've reached the end of the question and answer session. I'll hand the floor back to management for closing remarks.

Sandy Coombs
Sandy Coombs
SVP - Corporate Affairs & IR at Alkermes

Great. Thanks, everyone, for joining us on the call today. Please don't hesitate to reach out to the company if you have any follow-up questions. Thank you.

Operator

This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation. Have a wonderful day.

Executives
    • Sandy Coombs
      Sandy Coombs
      SVP - Corporate Affairs & IR
    • Richard Pops
      Richard Pops
      Chairman & CEO
    • Blair Jackson
      Blair Jackson
      Executive VP & COO
    • Todd Nichols
      Todd Nichols
      SVP & Chief Commercial Officer
    • Craig Hopkinson
      Craig Hopkinson
      EVP, R&D and Chief Medical Officer
    • Marcus Yountz
      Marcus Yountz
      VP - Clinical Development
Analysts
    • Paul Matteis
      Managing Director, Head of Therapeutics Research at Stifel Financial Corp
    • Anastasia Parafestas
      Equity Research Associate at Jefferies
    • Andrea Newkirk
      Biotechnolgy Equity Research at Goldman Sachs
    • Umer Raffat
      Senior Managing Director at Evercore ISI
    • Adam Ferrari
      Biotech Equity Research Associate at J.P. Morgan
    • Joseph Thome
      Managing Director, Senior Biotechnology Analyst at TD Cowen
    • Uy Ear
      Vice President at Mizuho Financial Group
    • David Amsellem
      Senior Research Analyst at Piper Sandler Companies
    • David Hoang
      Director, Senior Analyst, Biotechnology at Deutsche Bank
    • Ami Fadia
      Senior Analyst at Needham & Company
    • Ashwani Verma
      Executive Director - SMID Biotech & Biopharma at UBS Group
    • Leonid Timashev
      Biotechnology Analyst at RBC Capital Markets
    • Jason Gerberry
      MD & Equity Research Analyst - Biotech & Pharma at Bank of America Merrill Lynch
    • Luke Herrmann
      Research Analyst at Baird
    • Marc Goodman
      Senior MD - Neuroscience at Leerink Partners
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