MannKind Corporation

Good afternoon and welcome to the Mankind Corporation First Quarter 2026 Financial Results Earnings Call. As a reminder, this call is being recorded on May 6th, 2026 and will be available for replay on the Mankind Corporation website shortly after this call for approximately 90 days. This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from these expectations. For further information on the company's risk factors, please see the Form 10Q for the period ended March 31st, 2026, the earnings release, and the slides prepared for this presentation. Joining us today from Mankind, our Chief Executive Officer, Michael Castagna, and Chief Financial Officer, Chris Prentice. I'd now like to turn the conference over to Mr. Castagna. Please go ahead, sir.

Thanks, Operator. Good afternoon, everyone. Thank you for joining us for our Q1 2026 earnings call. Here's today's agenda, and I'll start with some opening remarks. In the first quarter, we continue to execute our strategy to evolve mankind to a diversified company positioned to deliver sustained long-term growth. The company is fundamentally different than it was even a few years ago, and we are excited about the near-term milestones that will further advance the company's evolution. Today, we will discuss the recent positive developments with United Therapeutics and articulate our growth plans that we expect will drive significant shareholder value over the coming years. Let's begin with our announcement earlier today that Mankind 1501 has been unveiled as Relenopeg DPI, which United Therapeutics optioned into back in August last year. Our formulation team has been moving Relenopeg DPI forward expeditiously, and we recently received a $5 million payment to prioritize the continued rapid advancement of this program. We have the potential to receive up to $35 million in development milestones, plus a 10% royalty on net sales. Of those milestones, we expect about $15 million to be earned over the next 12 months. This expanded collaboration is significant for a few reasons. First, it deepens an already productive partnership with United Therapeutics. Second, Merlinopec DPI has the potential to be used across pulmonary arterial hypertension, pulmonary hypertension associated with interstitial lung disease, idiopathic pulmonary fibrosis, and progressive pulmonary fibrosis, collectively impacting more than 250,000 patients and representing a substantial opportunity to improve the outcomes across these conditions. Third, it continues to validate our unique Technosphere platform, In addition to our Lenapeg DPI, we've also confirmed Mankind as a sole manufacturer of Tyvesa DPI under a supply agreement that includes contractual minimums. This provides us with a solid foundation as we continue to scale our Danbury, Connecticut facility for our own pipeline, including a manufacturing build-out to support the growth of your O6 ready flow. Now let's move on to Q1 performance. We delivered quarterly revenues of $90 million, a 15% increase over the prior year as this now includes the addition of Hero6. Q1 was a challenging quarter for several reasons. Number one is structural. We see each year as Q1 typically declines relative to Q4 due to annual deductible resets. As patients face higher out-of-pocket costs at the start of the year, we see both fewer fills and lower doses per prescription. For Furosix, doses per prescription were down roughly 20% in Q1 compared to Q4. Number two is transitional. As we prepared for our upcoming launches of Afrez and Pediatrics and the Furosix Ready Flow Auto Injector, we reorganized as field teams, leading to customer disruptions in Q1 as we didn't want to disrupt the field in Q4 or the upcoming next two quarters given the potential launches. Additionally, we reallocated marketing resources away from a Fresa adult, which slowed the growth year-over-year as we thought it would be more prudent to shift these investments towards the pediatric or Fresa launch and furosix nephrology opportunity. We have made the adjustments, and the field teams in place today are talented, highly experienced in their therapeutic areas, and have the right resources to deliver quarterly growth the balance of the year. Number three, as we prepare for the launch in Q3 of the auto-injector, we want to ensure an efficient conversion. We transitioned our inventory levels to minimize volatility and inventory stocking of the current own-body infuser at the specialty pharmacies. As this adjustment is now behind us, we expect future product outflows to better reflect underlying prescriber demand, which will help us accelerate the transition upon FDA approval. So when you put these three things together, Q1 came in lighter on the revenue side, but even so, the underlying indicators were more encouraging than the top line quarter may suggest. We saw growth in both overall writers and repeat writers up for 06, hitting a record number of prescribers in Q1, and demand momentum improved as the quarter progressed. Doses dispensed are up nearly 60% through April compared to the same period last year. Chris will walk through the quarter in more detail, but we are confident the underlying business is moving in the right direction and we remain on track to meet our full year 2026 406 revenue target of $110 to $120 million. Now let's walk through the Q1 highlights. The FDA approved the updated AFREZA label, which now provides clear starting dose guidance. That's an important enabler for the pediatric launch as this was the dosing used for the pivotal trial. We've also completed our launch build out for Afrezza pediatrics ahead of the May 29th PDUFA date. We completed the pilot phase enrollment in our inhale first pediatric trial, evaluating Afrezza in youth with newly diagnosed type one diabetes. That's the long-term goal I've talked about for years. Additionally, we settled the convertible notes, which strengthens the balance sheet. And finally, on the SC farm integration, we are now approximately seven months post-close, and I'm very pleased with how the integration has progressed. For most functions, integration is substantially complete, and we've identified synergies that exceeded our $20 million annual target we previously set. I want to thank both teams for the way they came together. These integrations are always challenging, and ours is going exceptionally well. I now take a step back to talk about a strategic evolution because this slide tells a really important story. Until 2022, we were essentially a single product company with Afreza. Since then, United Therapeutics and Tevesa DPI specifically has played a critical role in funding our transformation, including enabling SC Pharmacology. Our lung-targeted delivery approach is designed to address those barriers, and we are on track to report phase 1B top-line data in the third quarter, a key clinical de-risking step. In parallel, we are advancing Mankind 201 into a global phase 2 trial this quarter. Each of these catalysts will be significant on its own. Having all three in a single calendar year is a powerful testament to our progress and execution over the last 10 years. Together, these milestones strengthen our foundation and position us to potentially deliver meaningful growth in the years ahead. We have two near-term regulatory events, a growing commercial business, a strong revenue base from UT, and a pipeline approaching important data milestones. Now let's go deeper on data milestones. Now let's go deeper on the upcoming commercial expansion opportunities for our products, starting with Afreza. The pediatric opportunity is a well-defined new population entry point with the ability to expand across an even broader populations over time. There are roughly 360,000 people between eight and 22 years old live with type one diabetes in the US with about 30,000 newly diagnosed each year. And while our launch focus is type one in children and adolescents, when you look at the broader picture where Fresno has already indicated the long-term opportunity for inhaled insulin is significant, but over 38 million patients that were indicated for today. The pediatric opportunity is one of the most important milestones for Fresno since its initial approval, and our extensive research highlights why. Despite decades of technology and drug innovation in diabetes, A1C control is still not meeting goals, largely because of mealtime challenges that exist in the everyday life of patients. Afreza is the solution. After more than a decade on the market, Afreza is poised to finally live up to its potential. Managing mealtime insulin in children and adolescents often means multiple daily injections, rigid mealtiming, and significant burden on both parents and caregivers. Afreza directly addresses those challenges by eliminating mealtime injections through a novel route of administration.

Good afternoon and welcome to the Mankind Corporation First Quarter 2026 Financial Results Earnings Call. As a reminder, this call is being recorded on May 6th, 2026 and will be available for replay on the Mankind Corporation website shortly after this call for approximately 90 days. This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from these expectations. For further information on the company's risk factors, please see the Form 10Q for the period ended March 31, 2026, the earnings release, and the slides prepared for this presentation. Joining us today from Mankind, our Chief Executive Officer, Michael Castagna, and Chief Financial Officer, Chris Prentice. I'd now like to turn the conference over to Mr. Castagna. Please go ahead, sir.