Good morning and welcome to the MannKind Corporation's call to discuss its acquisition of SC Pharmaceuticals. The call will be available for playback on the MannKind Corporation website shortly after the conclusion of this call and will be available for approximately 90 days. During the course of this call, management may make certain forward-looking statements regarding future events and the company's future performance, including statements about the proposed acquisition of SC Pharmaceuticals, the expected timing thereof, and the expected benefits therefrom.
MannKind's and SC Pharmaceuticals' products and product candidates, including the ongoing and planned clinical trials, potential benefits, and market opportunity thereof, and other statements that are not historical facts. These forward-looking statements reflect MannKind's current perspective on existing trends and information. Any such forward-looking statements do not guarantee future performance and involve risks and uncertainties, including those noted in the Rules of Factors section of MannKind's and SC Pharmaceuticals' latest SEC filings.
Actual results may differ materially from those projected in these forward-looking statements. For the benefit of those listening to the replay, this call is being held and recorded on August 25, 2025. Since then, MannKind and SC Pharmaceuticals may have made additional announcements related to the topics discussed. Please reference MannKind's and SC Pharmaceuticals' most recent press releases and current filings with the SEC. MannKind and SC Pharmaceuticals decline any obligation to update these forward-looking statements except as required by applicable securities laws. Please also refer to slide two of our investor presentation, which contains important information about the proposed tender offer and where you can find more information. Joining us today from MannKind are Chief Executive Officer Michael Castagna and Chief Financial Officer Chris Prentiss. I'd now like to turn the conference over to Mr. Castagna. Please go ahead, sir.
Thank you, Operator. Good morning, everyone, and thank you for joining us today. We're excited to share a transformative milestone in MannKind's journey. O ur agreement to acquire SC Pharmaceuticals. At MannKind, our mission is simple yet powerful to give people control of their health and the freedom to live life. This acquisition is a direct extension of that mission.
Strategically, this will expand our footprint into cardiorenal medicine, an active complement to our existing presence in diabetes. It will accelerate our growth, strengthen our commercial portfolio, and reinforce our long-term strategies to seize opportunities that build our core strength, extend our reach into adjacent therapeutic areas, and reinforce our commitment to delivering innovative, patient-centric solutions for those living with significant unmet medical needs. Our strategy is anchored in five key pillars.
The first two, a presence of AsoDPI, our revenue-generating products today, and now FUROSCIX will be part of our key pillars. FUROSCIX will add a high-growth asset to MannKind as we look to build upon SC Pharmaceuticals late 2024 Salesforce expansion and its future launch in CKD. It will also strengthen our infrastructure by integrating the proven commercial model, cardiovascular expertise, and experienced team. Looking ahead, our clinical stage pipeline forms the final two pillars: inhaled clorphasmin, now in phase Three for NTM lung disease, and Nitrontin DPI entering phase Two for IPF later this year. Together, these five pillars will offer a balanced mix of near, mid, and long-term growth, positioning MannKind to deliver sustained value for our employees and stockholders. I would like to provide a brief overview of the proposed transaction.
Under the terms of the agreement, MannKind will commence a tender offer to acquire all outstanding shares of SC Pharmaceuticals' common stock at a price of $5.35 per share in cash, plus one non-tradable contingent value right worth up to $1 per CVR, payable upon achieving certain regulatory and net sales milestones. Additionally, at closing, MannKind will repay the processor debt and revenue share obligations currently estimated to be $81 million, assuming a 9/30 closing.
To support the acquisition and our broader strategic objectives, we've amended our recently announced financing agreement with Blackstone, securing $175 million in additional funding. The deal is expected to close in Q4 2025, subject to regulatory approvals and the satisfaction of customary conditions. Now, we would like to turn your attention to why we believe this acquisition unlocks meaningful synergies and positions us for sustained growth across cardiometabolic and chronic care markets.
The acquisition of SC Pharmaceuticals will diversify our revenue base and growth. With a presence in Vigo and FUROSCIX, we will have three marketed products generating revenue. Combined with some AsoDPI-related revenues, our annualized run rate exceeds $370 million based on Q2 2025 results. This positions us to accelerate double-digit annual revenue growth and expand our market reach. Next, FUROSCIX is gaining significant traction. The Salesforce expansion in late 2024, the ongoing launch into nephrology, and the accelerating growth in integrated delivery networks have laid the groundwork for continued growth. In addition, the anticipated FUROSCIX ready-flow auto-injector approval will not only enhance FUROSCIX's market potential but also reduce costs.
Finally, MannKind and SC Pharmaceuticals share a strong cultural and strategic alignment, both committed to delivering patient-centric therapies for those living with significant unmet medical needs. There is strong synergy across our commercial products with a significant percentage of CHF and CKD patients with fluid overload also living with diabetes. We feel that this provides a meaningful opportunity to unlock significant growth for the combined portfolio. By integrating SC Pharmaceuticals' drug-device combination expertise and its Boston-based team, we will strengthen our therapeutic presence in cardiometabolic care.
Now, I'd like to discuss the significant unmet need that exists for patients living with CHF and CKD. Fluid overload is a hallmark of CHF and CKD. While oral diuretics are commonly used in stable patients, their effectiveness becomes highly variable when fluid retention worsens. Nearly 60% of heart failure admissions are directly linked to this issue, yet the current treatment paradigm often falls short, with 25% to 30% of patients readmitted to the hospital within 30 days. FUROSCIX offers a way to interrupt this cycle, helping patients keep their symptoms in check and potentially avoid unnecessary hospital admissions.
Now, let's talk about FUROSCIX and why we're so excited about this product. The burden of fluid overload is immense, and FUROSCIX addresses a critical gap in care by helping to break the cycle of hospital admissions and readmissions. FUROSCIX is a wearable at-home treatment that delivers furosemide, the gold standard hospital diuretic delivered subcutaneously via an on-body infusion, offering IV-like effectiveness without the need for hospitalization.
It's pH neutral, well-tolerated, and has near complete bioavailability, meaning patients receive consistent and reliable absorption, a key problem with oral diuretics in patients with worsening fluid overload. It's a great example of how MannKind is delivering on our mission to give people control of their health and the freedom to live life. One of the most exciting aspects of this acquisition is SC Pharmaceuticals' strategic approach to lifecycle management.
The development of the ready-flow auto-injector reflects a clear focus on patient expansion through formulation and device innovation. By reducing treatment times to less than 10 seconds, the ready-flow auto-injector is designed to dramatically improve patient convenience, potentially enabling broader adoption across CHF and CKD populations if approved. From our perspective, the time-to-forward-thinking product strategy is exactly what we've been looking for.
The FUROSCIX ready-flow auto-injector aligns with our commitment to optimize drug delivery and patient-centric innovation. The strategic importance of this launch was reflected in our deal structure. We've offered up to $0.75 from the CVR to the auto-injector's FDA approval, a substantial portion of the total CVR value. With an FDA submission target of Q3 2025, we'll be focused on supporting a successful launch as early as Q3 2026, if approved. FUROSCIX continues to deliver strong performance, with $28 million in revenue in the first half of 2025, representing 96% growth year over year.
Sales to integrated delivery networks continue to increase, reflecting growing provider confidence and increasing integration into various care pathways. This level of momentum gives us confidence in FUROSCIX' long-term growth trajectory. That's why we've tied the remaining CVR of up to $0.25 to achieving $120 million in sales by the end of 2026. We believe MannKind is uniquely positioned to scale FUROSCIX and unlock its full market potential in the future.
First, we bring strong financial foundations and commercial infrastructure to support continued growth in CHF and accelerate the CKD launch. Second, our deep expertise in drug-device combination products, from development to regulatory approval and commercialization, positions us successfully to launch FUROSCIX ready-flow auto-injector if approved. Third, there's natural synergy with our endocrinology footprint. The significant % of patients with CHF and CKD also living with diabetes allows us to leverage existing relationships, sales channels, and care models to deliver adoption.
Fourth, integrating FUROSCIX into our broader portfolio will enhance scale and efficiency. Shared infrastructure across sales, marketing, distribution, and payer engagement will reduce fixed costs and improve agility. Finally, this acquisition is expected to strengthen our long-term sustainability, diversify our revenue base, and increase strategic optionality, making MannKind more attractive to employees, partners, investors, and the broader healthcare ecosystem. Lastly, I want to highlight our stairway to building value.
AsoDPI continues to be the foundation in the near term, providing non-dilutive funding and anchoring our inhaled therapeutics platform. Looking ahead, our newly rebranded cardiometabolic business, formerly the endocrinology franchise, will represent a major growth engine. With a presence in Vigo and FUROSCIX, we will expand our reach across heart failure and chronic kidney disease. FUROSCIX is expected to add immediate momentum with multiple near-term catalysts.
First, rapid revenue growth and growing hospital system adoption. Second, the recent CKD approval and expanded shortlisting. Third, the upcoming FUROSCIX ready-flow auto-injector FDA approval. Non-cardiometabolic for additional ultimate franchise and Wassim Fares and Nitrontin DPI. Together, these programs are expected to form a scalable, synergistic portfolio that will position MannKind for sustained growth and long-term value creation. As we close today, I want to reiterate that we're thrilled to welcome the SC Pharmaceuticals team to MannKind. This acquisition is strengthening our portfolio, expanding our reach, and enhancing our ability to deliver value to patients, employees, and stakeholders. Thank you for listening, and I'll now turn the call back over to the Operator to open the line for questions.
Thank you for watching, Sharon. For the second session, we'll be utilizing the device transmitter. If you don't have a question, you can click on the device handpiece following the machine. If you have a question, you can ask your question. If you don't have a question, then follow up before the whole record is here. We'll now pass the line to someone here. Your first question comes from Brandon [Wolfram]. Is he willing to stop me if you want to ask a question?
Good morning. Thanks for taking the question, and congratulations on the acquisition. My name is two from these. First off, you know, if I look at SC Pharmaceuticals' SG&A line, any color in terms of kind of spend, what's marketing versus the material marketing versus overhead? The key color on potential possibilities and what you expect to do could be accretive. Secondly, maybe you can just talk about SC Pharmaceuticals' manufacturing footprint, what you intend to do with that, and how it fits into Bambry and overall capacity. That's it for me. Thank you.
I can hear you.
Hi, I can. Okay, great. On the CVR, I think it's crucial to comment on the breakdown and how we're thinking about it. We've strictly gone through closing Q4, so that'll be an update as we get closer to the end of the year. In terms of creating this thing, we expect this to be accretive as we look at this like late next year, I'll see about a year after the close of this transaction. On the manufacturing footprint, obviously, as we've done with the key post team, a lot of work to do outsourced, justified, we saw where they are.
We will look to see what we can do in Bambry in terms of, you know, there's a testing that we need to do there, especially as it gets ready for the sub-Q launch. We have a large footprint, as you have seen. That's the biologics manufacturer for open-source sterile and injectable. That's stuff that could be modified if appropriate. Otherwise, nobody has a significant growth opportunity. They have enough manufacturing capacity to continue to sustain the growth that we want to have in the future.
Great. Thank you very much, Dr. Garfield. I hope I can be okay.
Thanks for your question, Brandon. Our next question comes from [audio distortion ]. Please go ahead with your last question.
Hi, good morning, guys. Thank you for the question. I'm just interested in talking a little bit more about why you decided to do cardiorenal and major based on CHF and CKD and your existing franchise. Obviously, both on a therapeutic perspective, but also just considering that this is a lot of injector device versus a polymer approach.
Got it. I'm fine with it. I think if you look at us, we've always been, I'll say, psychomagnostic, meaning like with Wassim Fares being a fund nebulizer, a lot of our history is in respiratory. We're looking for something that would diversify our revenue stream that can culturally fit with the company and have some adjacency or overlap within areas we're looking to do, whether it's lung or endocrine. This would fit a lot of those check boxes that we were looking at in terms. If you look at the patients with heart failure and CKD that have these fluid overload challenges, a lot of them do live with diabetes.
There's a large overlap with cardiovascular patients. They're probably on insulin. Especially if you look at the nephrology launch, there's a large synergy in terms of where those therapies are located, where our diabetes therapies are located. We believe it becomes one of the main jobs to get to where we are today. Bringing more sales efforts and more marketing will help grow this product faster, especially as the sub-Q touches on the market next year. That was a lot of the work there. I also think the platform needs to be left to that part. We actually own Vigo, as you know.
Having, I'll say, an online injector platform, and we have some experience with that. I think just there's not a lot of people that are designing those free meaningful platforms out there. We own buying injector experience. As a company, we have a lot of injector experience, drugs like combinations, as well as injectables. We feel pretty confident in terms of being able to integrate and work together and make sure we fulfill manufacturing challenges and opportunities that come up with those drug-based challenges. These are things that the company's had with us for over 20 years.
Okay, great. Thanks.
Last question, there are quite a few questions from the room as well. I'll just pause the questions. Please go ahead with your line and ask a question. As a reminder, today is a great day to ask questions.
Hi, you're taking the last 42 questions. My question is on the adaptation of the new business weblog. Yes, $975 million, as we spoke to him immediately, it's a lot of in the. At the top of an original academic industry announcement back in the middle of the year this month. Would there be any impact on the original agreement in terms of the structured timeline, please? Thank you.
Thank you. That sounds like a great question for Chris.
Thanks. We amended the Blackstone deal that we did a few weeks ago. In summary, we have now borrowed $325 million that will be effective with the close of the transaction, and we have $50 million remaining, which is committed but unfunded from Blackstone. That's the summary of where we ended up after the amendment.
Maybe a follow-up question on the Salesforce. How do you expect to coordinate between the existing Salesforce from SC Pharmaceuticals and your existing Salesforce? Will there be any modifications in terms of the targeting, the column, for example, et cetera? Thank you.
I think that's a great question. That's probably one we'll hold till the deal closes to speculate what the future footprint looks like. We'll give more updates as we get closer to that date.
Great. Thank you very much.
Thank you.
Thanks so much for your question, Neil. Just a reminder, everyone, please use the raise hand feature at the bottom of your screen to ask a question if you have one. Our next question comes from Brandon Fulks from H.C. Wainwright. Once again, you can unmute your line and ask your question.
Hi, thanks so much for the follow-up. Mike, I just want to jump ahead a little bit. Can you just talk about how you see MannKind longer term, just strategically, right? Your pipeline, obviously, is very orphan drug focused. How does this acquisition change your thinking on perhaps building an orphan-loan commercial organization versus continuing to be acquisitive between now and the time those products come to market?
Maybe layered into that, can you just talk about the focus over the next few years? It looks like the cadence of launches between Afrezza Peds and the auto-injector is well laid out. Can you just talk about the company focus, the reason to do it now ahead of the Afrezza Peds potential launch as well?
Great question, Brandon. I think when you look out, you know, so much, thanks to United Therapeutics, AsoDPI has been strongly successful. I think when you get to our quarterly earnings revenue and guidance here, it's really hard for us to really think about how do you drive faster growth? What can you control with just Afrezza versus the pipeline coming? Also, you know, the investment community these days are momentum investors and are looking for milestones that are happening at certain periods of time.
I think when we look out over the next two, three years, first, when you think about the Osgoode-Bornstrom business and this is what they have in common, I think is important. Number one, drug-device combinations is kind of the heartbeat of the company when you look at that. Number two, the advocacy that has to occur in these various disease states is critical.
Number three, the distribution model we like at SC Pharmaceuticals, it's a closed model. As you think about clorphasmin coming soon, that'll be a closed model as well. As we look at global expansion opportunities in Japan and Europe with Afrezza and clorphasmin, these also become another product in our armatorium here to bring to those markets as well.
You know, there's a lot of commonalities around what we are trying to build from a capability as a company and how these all fit together. If this was a low price point product that's going to require 500 reps, that's not what we're interested in. It's a very specialized product to help patients that have a very, very important urgent need around hospitalizations, reducing readmissions, and preventing hospitalization. You know, when you look back in time, there's several great examples of innovations around the space.
One of which we deal with every day is insulin pumps, right? It's about a $5 billion market, delivering a 100-year-old product to really help patients manage their insulin better. We see the same thing in the labs that went out with Amgen in terms of preventing hospitalizations there with the drug-device combo. We do look at this as a large opportunity that really solves some of that need.
It's a really difficult product to get to market. There's very few products that get to market that allow you to have this opportunity at the stage of launch that they're in. We looked at this as a great bolt-on that kind of fit our long-term strategic view within the endocrine space and the metabolic space, as well as the orphan loan as we look at the company together.
Great. Thanks so much for your follow-up, Brandon. Our next question comes from Tiago Fauth from Wells Fargo. Please unmute your line and ask your question.
Great. Thanks so much for taking the question. I'm just trying to understand here the revenue opportunity, right? Like the TAM, it's theoretically very large. FUROSCIX exited Q2 at an annualized rate of about $60 million, mid-$60 million. Big sales consensus is much greater than that. What are the key drivers going forward? Is it further penetration and expansion in CHF? Is it mostly about CKD? Anything you can kind of give us at this point in terms of what can we expect from a revenue trajectory perspective? Thank you.
Hey, Tiago, thank you for the question. I think it's too soon to give guidance or speculate. I think we have to close the deal. In general, what I would say is we believe continued efforts of what SC Pharmaceuticals has been building around salesforce expansion, bigger marketing opportunities, raising awareness. We think they're at that value inflection when you look for adoption of a product, the number of writers you're getting, the depth of prescribing you're getting.
It takes a little bit of time. I think they're right on the cusp of that opportunity to scale the business faster and keep going. That's kind of what we looked at and saw in this opportunity. Yes, a large market, but it doesn't take a lot. As you know, there's not a lot of competition to do what this product does. We feel that unique area is going to be well served by SC Pharmaceuticals.
Fair enough. Thanks again.
Thank you.
Thank you for your question, Tiago. That was your last question, team. I'd now like to turn the call over to Mr. Castagna for closing remarks.
Thank you, everyone. This is a great milestone in the history of MannKind. Hopefully, our shareholders and our employees will start to see the opportunities that come together over the coming quarters and months. I look forward to working with you all and seeing you at the upcoming conferences. Thank you.