MannKind Corporation Q3 FY2025 earnings call

1. Q3 Highlights: Delivered a record revenue quarter of $82 million. Strengthened portfolio with acquisition of scPharmaceuticals. Afrezza supplemental BLA accepted for review with PDUFA date Q2 2026. Tyvaso DPI had strong performance with $59 million in royalty and manufacturing-led revenue. 2. Pipeline and Acquisition: Completed acquisition of scPharmaceuticals, focused on unlocking FUROSCIX potential and advancing inhaled bumetanid (MNKD-701) for fluid overload in CKD and heart failure. 3. Near-Term Growth Catalysts: sNDA for FUROSCIX auto-injector submitted to FDA in Q3 with expected PDUFA date Q3 '26. Afrezza sBLA accepted for review. Enrollment completed ahead of schedule in ICoN-1-NTM Phase III. 4. Commercial Highlights: Tyvaso DPI had highest revenue quarter in Q3 with $33 million in royalties and $26 million in manufacturing-related revenue. Afrezza grew 31% in new prescriptions and 27% in total prescriptions Y/Y. FUROSCIX had over 27,000 doses dispensed in Q3, up 153% from same quarter last year. 5. Clinical Development: Advancing MNKD-101 and 201. INFLO Phase II (Nintedanib DPI) with first patient enrollment expected in Q1 2026. ICoN-1-NTM III期 completed enrollment ahead of schedule.

In the third quarter of 2025, total revenues reached $82 million. Royalties earned on Tyvaso DPI increased 23% to $33 million, and manufacturing-related revenue was $26 million. Afrezza net revenue grew 23% to $18.5 million. FUROSCIX had unaudited revenue of $19.3 million in Q3, with year-to-date revenue for FUROSCIX reaching $47.1 million, a 95% increase compared to the same period in 2024. Tyvaso DPI's royalties and manufacturing-related revenue together contributed a significant portion to the total revenue, with Afrezza and FUROSCIX also playing important roles in the revenue composition.

1. The sNDA for FUROSCIX auto-injector was submitted to the FDA in Q3 with an expected PDUFA date of Q3 '26. 2. The Afrezza supplemental BLA was accepted for review, and if approved, could be the first new insulin for pediatric patients in over 100 years. 3. Enrollment was completed ahead of schedule in the ICoN-1-NTM Phase III, allowing for sizing of the trial mid next year. 4. The INFLO Phase II (Nintedanib DPI) is expected to have the first patient enrollment in Q1 2026.

1. Competition risks from competitors of FUROSCIX, including potential pricing and market share challenges. 2. Regulatory risks associated with the approval processes of various submissions such as the sNDA for FUROSCIX auto-injector and the Afrezza supplemental BLA. 3. Financial risks related to the company's balance sheet, including the need to deleverage and manage debt obligations.

Q: Can you share any thoughts on the recent approvals from FUROSCIX competitors? And if you could help contextualize the pricing differences and how that actually funnels down in terms of actual out of cost. Or out-of-pocket cost to patients? And then just in terms of FUROSCIX growth, when do you think we'll actually start to see a bigger inflection in growth from all of the different initiatives that you're doing to help drive greater adoption? And then I've got a follow-up question on IPF.

A: So I think on the competitors, when we were going to due diligence, we knew these 2 competitors were in the wings. And I think we felt the product differentiation stood on its merits, along with the life cycle management of the auto-injector. So that's been the key focus for us. And then I think in terms of the nasal one that got approved, we could see how skinny that package was and how quickly that could get to market, which played into our decision to advance an inhaled butmetinide on our FTKP platform. And the reason is we know our platform has IV-like responses and good bioavailability. And we felt that's exactly what you're looking for in this fast onset of diureysis, especially as you read the VuMex branded label, you can see the quick onset with IV, and the diuresis starts pretty much within 15 minutes or so. So that really allowed us to create another differentiated product as a part of this acquisition, which we wouldn't have done had we not bought scPharma. So I think from a competitive viewpoint, we'll be able to compete nicely with the new people come on the market. I think just like we see in the case of Liquidia launching in treprostinil, the market size grows with more share of voice, more noise, and more reminders of this opportunity. The market is severely underpenetrated, and scPharma had to fund all this on their own. So having more noise out there and more options, I think, ultimately is going to the market and the believability of this opportunity. In terms of pricing, I mean, these companies have stated a price, but they have not yet actually publicly loaded their prices to my knowledge. And I think let's see what happens when they do. But the pricing of the product is not going to change the biggest barrier in Medicare, which is somebody's out-of-pocket cost. So whether it's $500 or $1,000 or -- the out-of-pocket cost and the deductible is the same on Medicare, which is the majority of these patients in treatment. So the real issue is not the WACC price of the product, but it's the net price to the patient. Unless somebody is doing smoothing, the payers aren't going to just cover any of these products really, nearly because they're going to be up against generics in the marketplace. So you're going to need reimbursement support. You're going to need to figure out the smoothing and the prior refill. So I think I like the SC model. I like that we know where our patients are. We know when they get a refill. We know when the prior auth expires. So I think the system that they have in place is good. You'll hear some complaints that people want to access locally, and that's a lot of the IDN contracting. So I think that we'll continue to watch it. We'll be competitive if we got to make changes. But I think in the end, we feel pretty good about our price point and our net pricing. On the growth inflection, I mean one of the things you'll start to see next year is increasing the share of voice. And I think you could see in the 6 months plus of their sales force expansion, you started to see that kick in, in Q2, but really kick in, in Q3, and ultimately Q4. So I think from the time we make these investment decisions, you can expect to start to see impact 6 months -- within 6 months there. So hopefully, you'll see the TAM expansion that will take at least 6 to 9 months in terms of really starting to make impact in the health system. They don't change overnight. But in terms of rep share of voice, I think we could see an impact on prescribing sooner. And I think that will be our focus is to kind of minimize disruption with customer relationships, but expand the share of voice on cardiologists and nephrologists as we go into '26.

Q: Just wanted -- I had 2 questions. One, just on thinking about the scPharma acquisition and FUROSCIX. Could you comment a little bit on the integration process with respect to the field force, how that's been going? And if you have any updated thoughts on kind of what the field force composition will look like across your kind of multiple commercial brands now? That's the first one and then I have a follow-up as well.

A: Sure. I'd say, first, as we got to integration, it's only been closed about 3 weeks, and it feels like we've already met most of the employees once or twice. I personally was at 5 of the regional sales meetings. Nick, our President, was at the other 3. We had multiple days of integration calls getting ready for '26. So I think the integration is going very smooth. Culturally, the companies are very similar. So there's not a lot of friction. We already have put some of their people in key positions on our side. and integrating them into our leadership team and our processes. So I think overall integration, we don't see much disruption. Sales continues to look strong in Q4 here. So we're very happy to date with the teams and the integration as it goes. You'll see scPharma continue to be independent through the end of the year in terms of their name and job postings, things like that. You'll start to see that integration fully in '26 starting in January, all the way through any packaging changes, et cetera. So we're trying to make sure we're smart about it. We're not looking to waste money on changing the name on a box for no reason. So we'll try to phase those things in as we think about like the autoinjector launching, things like that. So I think that answers the integration question.