Mineralys Therapeutics, Inc. Q4 FY2025 earnings call

John Collison began by overviewing the business, clinical programs, and recent milestones, including the FDA's acceptance of the NDA for Lurunderstat for hypertension with a PDUFA target date of December 22, 2026. He discussed the successful clinical program for Lurunderstat, market access planning, payer engagement, and medical communications efforts. Adam Levy reviewed financial results, noting cash, cash equivalents, and investments were $656.6 million as of December 31, 2025, R&D expenses decreased, G&A expenses increased, other income net increased, and net loss decreased compared to prior periods. John also mentioned other development activities like the EXPLORE-OSA trial which showed blood pressure reductions and favorable safety profile in a high-risk population with difficult-to-control hypertension.

Q: Now that the potential launch of LorangerStrat is roughly six months behind your direct competitor, what are you hoping to learn from this competitive launch that would optimize the success of LorangerStrat's launch? And second, could you offer any additional color on the pre-launch payer interactions you've been having?

A: Mike was told they're excited about the timeline, see a significant market opportunity, are aware of AstraZeneca's potential launch, think there's room for two novel therapeutics, are bullish on Lurunderstat's profile, feel bullish on access especially for third line or later, and the comprehensive data set will help with translation to reduced cardiovascular risk for patients.

Q: When you look at the results from the Phase II OSA study, do you think the desired limited laryngeal sets potential to show benefit in the AGI primary endpoint? And then I have a follow-up.

A: Rich was told the study was important to complete to show BP reduction and safety in high-risk patients, it's unclear if the study duration and design tested laryngeal set effects, they'll look at a more representative population to answer the question, and their objective isn't to claim treatment of OSA but to know about long-term outcomes in patients with OSA.

Q: When you look at the results from the Phase II OSA study, do you think the desired limited laryngeal sets potential to show benefit in the AGI primary endpoint? And then I have a follow-up.

A: Rich was told the study was important to complete to show BP reduction and safety in high-risk patients, it's unclear if the study duration and design tested laryngeal set effects, they'll look at a more representative population to answer the question, and their objective isn't to claim treatment of OSA but to know about long-term outcomes in patients with OSA.

Q: Just to follow up on the commercial side of things, can you just help us understand, you know, what you believe the number of reps would be to, you know, launch the Lorentz stat effectively versus AstraZeneca? And do you envision having a, you know, sort of differentiated approach to market than Astra? you know, if there is a differentiated approach, what would that be?

A: Seamus was told they're continuing to evaluate the number of reps, look at the 60,000 prescribers who are responsible for half of the script in third line or later, and will look at broad IMS data and subsegments of physicians treating specific types of hypertension with related comorbidities for rapid uptake.

Q: Just wanted to quickly follow up on the payer access discussions. I think the comment was maybe favorable access with a certain segment of payers. So, I was wondering if you can expand upon that a little bit and just get a sense of your confidence in breadth of quality coverage 3L plus. as I guess you've articulated in the past. And then one CFO question here, just from an R&D perspective, thinking about 2026 R&D relative to 2025, should we be thinking about, I don't know, cash burn mitigation effort, or is 2025 a good run rate for the company? And then last one for me is just on the OUS regulatory submissions, apologies if I missed this in past commentary from you guys, but is that in any way gated at all by the partnership discussions? If you can give us a sense of, you know, when you anticipate the OUS submissions.

A: Jason was told they've done a great deal of research on payer access, feel strong about the value proposition of lorundrastat, continue to work aggressively on it, in 2025 R&D was a heavy lift, expect less R&D activity in 2026, and partnering may play a role in OUS regulatory submissions and co-development.

Q: Just a little bit more on the commercial side. Maybe you can help. I know it's probably too early to talk about pricing, but is there any scenario where – the competitor can angle for third line while you're putting yourself in fourth line first? Are you thinking about the possibility of using pricing as a competitive lever? And what kind of things do you need to do to get yourself into third line? And then as a follow-up to that, just with Explore CKD and Explore OSA, are you actually seeking to put it in the label or as a differentiating feature or just have the data available for presentation and publication?

A: Annabelle was told it's too early to talk about pricing, the value proposition of La Runderstad resonates, it's a beachhead at fourth line and begins to open up third line, Explore CQD may be part of the NDA application, Explore OSA was not part of the original NDA application but will be informative to the medical community.

Q: Just try to double click on the 60,000 prescriber number, John, you mentioned. Wondering, is this primary care heavy or these are specialists that you would be targeting? And then what sort of role direct to consumer marketing type of mechanism could play for a market like this?

A: Mohit was told it's a 60-40 split primary care specialty, bulk being cardiologists, and they'll use broad macro data and primary market research to target true prescribers, and they don't have a consumer strategy to talk about yet but will speak to patients about the importance of blood pressure control.

Q: I guess I know it was a small study, but did you observe any differential treatment effects in blood pressure reductions or AHI across any kind of key subgroups in Explorer OSA? And I guess a particular focus in those receiving and not receiving CPAP? And then maybe secondly, I know you touched upon potential future indications. Is the goal to be first in class for those indications, or are they large enough similar to hypertension where it doesn't matter?

A: Rami was told they're examining deeper into the data for subsets, it's hypothesis-generating, they'll present analysis at future meetings, there was no difference seen between those on and not on CPAP with small numbers, and their intent is to not be a follower and look for white space with lorundrastat in aldosterone-driven conditions.

Q: Maybe a little bit more on the potential partnerships, and if you could talk about what an ideal partnership looks like in terms of capabilities and also creative deal structuring. Obviously, the commercial infrastructure is important, but what other nuances are important to you, maybe in terms of R&D funding or bigger indications in payer relationships? I know that you mentioned that there's opportunity in pursuing some indications on your own and others involved maybe partnering it on. Any color there would be helpful.

A: Georgia was told they'd like a partner that sees the opportunity with loranderostat the way they do, for co-development and extending the value beyond hypertension, and finding a partner that thinks holistically about the opportunity with significant IP and time period to realize value.