Welcome to the MannKind Corporation Annual Meeting of Stockholders. As a reminder, this broadcast is being recorded on May 20, 2026, and will be available for playback on the MannKind Corporation website shortly after the conclusion of this meeting. Please be reminded that this call may contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainty, which could cause actual results to differ materially from these stated expectations. For further information on the company's risk factors, please see the most recent 10-Q report filed with the Securities and Exchange Commission on May 6th, 2026. With the start of this meeting, the voting portal is now open. You do not need to vote through this portal if you have already sent in your signed proxy. Those who wish to vote via the portal may do so now until the secretary announces the polls are closed for voting.
I would now like to turn the meeting over to Dr. James Shannon, Chairman of the Board of Directors of MannKind Corporation. Dr. Shannon, please go ahead.
Thank you, operator. Good morning, welcome to MannKind's Annual Meeting of Stockholders. I am James Shannon, Chairman of the Board of Directors of MannKind Corporation. I will preside as chairman of this meeting, which I now call to order. I would first like to introduce the other members of the board of directors of the company who are present today. Michael Castagna, also our Chief Executive Officer, who will provide his remarks after adjournment of the formal meeting. Steven Binder, Ron Consiglio, Michael Friedman, Jennifer Grancio, Anthony Hooper, and Christine Mundkur. Sabrina Kay has joined us remotely. Continuing with introductions of our other corporate officers in attendance of this meeting are Christopher Prentiss, our Chief Financial Officer, Ajay Ahuja, our Chief Medical Officer, Sanjay Singh, our EVP of Technical Operations, David Thomson, our General Counsel and Corporate Secretary, and Stuart A. Tross, our Chief People and Workplace Officer.
This meeting is being held pursuant to the notice of the annual meeting mailed to all of the company's stockholders on April 7th, 2025. David Thomson will serve as Secretary of this meeting. Maria Robles was appointed as the Inspector of Elections for this meeting. Ms. Robles has taken and subscribed to the customary oath of office to execute her duties with strict impartiality. We will file this oath with the records of the meeting. The Inspector of Elections decides upon the qualification of voters, accepts their votes, and when balloting on all matters is completed, tallies the final votes. Broadridge has provided MannKind with a certificate indicating the number of votes represented by proxy at this meeting. I will now ask Mr. Thomson for his report. David?
Mr. Chairman, I have a list of the holders of common stock of the company at the close of business on March 23rd, 2026, the record date of this meeting. The list of stockholders of record is available for inspection by stockholders of record during this meeting for any reason germane to this meeting. Only holders of record of common stock on the record date were entitled to notice of this meeting and to vote at the meeting. I also have a copy of the notice of this meeting, together with a declaration as to the mailing of the notice. The holders of a total of 233,461,993 shares are represented at this meeting, either in person or by proxy. Since there were 308,795,777 shares of company common stock outstanding on the record date, a majority of the outstanding common stock is represented here today, and a quorum is therefore present.
The meeting is authorized to transact business.
Thank you, David. At this time, we will address the items of business set forth in the notice of this meeting. There are three proposals to be voted on at the meeting today. These proposals were further described in the proxy statement dated April 7th, 2026, which was made available to all stockholders. The first proposal is the election of nine directors. Each director that is elected will hold office until the next annual meeting of stockholders and until their successors are elected. The nine nominees are myself, Chairman James Shannon, Michael Castagna, Steven Binder, Ronald Consiglio, Michael Friedman, Jennifer Grancio, Anthony Hooper, Sabrina Kay, and Christine Mundkur. These nominations need no second, the nominations are closed.
The second proposal to be voted on is to approve, on an advisory basis, the compensation of the named executive officers of MannKind, as disclosed in MannKind's proxy statement for the annual meeting. The third and last proposal to be voted on is to ratify the appointment by the Audit Committee of Deloitte & Touche LLP, firm for the fiscal year ending December 31st, 2026. The secretary will now describe the voting procedures. David?
Each share of common stock is entitled to one vote. Voting is by proxy of written ballot. You do not need to vote through this portal if you have already sent in your signed proxy. While we allow for online votes, our stockholders should know that the final tally of votes will be reported in a current report on Form 8-K, which will be filed within four business days following this meeting. If you have not voted, I encourage you to vote online now. You still need to. The time is now 9:07 A.M. Eastern Time, and the polls are closed for voting. Chairman, the report of the Inspector of Elections indicates that each of the nine nominees for director has been elected.
The proposal to approve, on an advisory basis, the compensation of the named executive officers of MannKind was approved, and the selection of Deloitte & Touche as MannKind's independent registered public accounting firm has been ratified.
Thank you, David. I would like to thank you all for your interest and attendance at this meeting. This concludes the formal portion of the meeting, and now we will proceed with our CEO's remarks and allow our executive team to be available for appropriate questions. With that, I would now like to hand over to our CEO, Mike Castagna. Mike, go ahead.
Thank you, James, and good morning, everybody. It's an honor to be here, and I appreciate all of your support. As we sit here today, our strategic evolution has never been more at the forefront of where we are than our last 10 years together. We started with Afrezza all the way through 2022, 2024. We expanded with the launch of TYVASO DPI and our partner with United Therapeutics. We pursued our first large acquisition in 2025, adding FUROSCIX, a major growth driver. As we sit here in 2026, we are now at the precipice of an FDA approval here on pediatrics for Afrezza, which we've worked on for over a decade, an opportunity with FUROSCIX and an auto-injector, as well as a pipeline. We are well-positioned for growth as we look forward to our next decade.
Some of the near-term catalysts we have right in front of us, as I just mentioned, is a PDUFA date within the next 10 days for Afrezza pediatrics. This will expand the population who has a huge unmet need to a very unique value proposition in a segment where timing of your meal, the unpredictability of a child, and running around as teenagers is going to be an incredible opportunity to transform Afrezza. This will compound growth as kids turn to adults and those adults teach the adult endos how to use the product successfully. I turn my attention to FUROSCIX ReadyFlow Autoinjector. PDUFA date here is July 26th. This will reduce the administration time from hours or even a hospitalization to just seconds. This is going to support broader use of FUROSCIX, broader use, hopefully, of early hospital discharge, where loved ones can spend their time at home.
We significantly reduce our COGS to the tune of potentially 70%. Finally, nintedanib DPI, which has an urgent need for IPF treatments. The patients here have an 80% chance of death within five years, and new treatments are necessary and tolerable treatments are necessary. We believe lung-targeted delivery to address the unmet need here in IPF and the barriers to successful treatment are critical to the future of this disease. Our first key de-risking step just occurred where the IRB approved us to go to cohort 2 and go to the next cohort of dosing. This should be wrapped up here, hopefully by the end of Q2 or early Q3, and we will share updates with you shortly. The phase II study is now open for enrollment, and we expect our first patient momentarily. I want to comment on our collaboration with United Therapeutics.
Those of you who have not been following the story, we have a great opportunity in front of us to not only see TYVASO DPI continue to expand in IPF and PPF, but the opportunity to see what was called 1501 is now known as ralinepag DPI. We recently received $5 million from United Therapeutics to accelerate the advancement of this program and ensure the focus on getting this into patients as quickly as humanly possible is in front of us. We expect $35 million in milestones and royalties, and $15 million of those milestones should come in the next 12 months. This is a progressive disease with many iterations of pulmonary fibrosis, idiopathic pulmonary fibrosis, pulmonary hypertension with interstitial lung disease. Huge unmet needs with not a lot of options. We're excited about ralinepag as well as TYVASO DPI moving in those populations.
If you look back at where we started even just five years ago, our revenue has gone up significantly. Our growth drivers have diversified. The future in front of us to grow from this platform is exponential. We have a robust pipeline, we have several FDA-approved products, and we have diversification now in front of us. It's never been a better time to be an investor, a shareholder, an employee, or a patient that we serve. We're really excited about everything in front of us. All this together well positions us for our next phase of growth. The corporate transformation is underway. You think about UT and what that brought to us is the ability to place the bets and invest in the opportunities we have, whether that's purchasing scPharmaceuticals, it was investing in the pediatric opportunity or advancing our pipeline forward.
All this was made possible because of our UT collaboration. Our revenue mix is evolving towards MannKind products. As we exit this year, take away the manufacturing revenue because that line will be a steady line as we go forward. Really look at the growth drivers of the company. It's going to become FUROSCIX ReadyFlow Autoinjector, Afrezza, and the pipeline. We're really excited about this corporate transformation as we'll be in more control of our revenue as we move forward. For FUROSCIX, we expect to achieve $110 million-$120 million in revenue in 2026. In Q1, we faced large deductible of almost $700 a month for a patient. The ReadyFlow Autoinjector will launch here in Q3 and Q4, where co-pays are now diminished and the opportunity to scale is tremendous. We're looking forward to continuing to see FUROSCIX success.
We can already see positive trends as we come into Q2 and close that out. Afrezza pediatric expansion really unlocks a growth opportunity we all have been waiting for. We have a targeted sales and marketing approach where we will be ready to go day one of approval, hopefully starting with ADA in a few weeks. The pediatric opportunity is about 1,200 to 1,400 prescribers, and we have an opportunity to really meet them at their place of treatment and get to a targeted audience that really will understand the benefits of Afrezza. We've talked about our UT partnership, which will provide a durable base and an expanded scope with the pipeline of ralinepag.
Finally, we're in 100% control of the patent of DPI, and this is a de-risking program as we come up on the phase I completion, where we can see no reports of diarrhea and no discontinuations due to safety or cough. We're really excited for this program. It's going to help a lot of patients, but we do have to get into the phase II program to understand the FVC and FEV1 opportunity. We look forward to seeing many investors at the upcoming Jefferies conference in New York here on June 3rd, and we look forward to continuing to engage a dialogue with you over the coming months and years. I'm going to stop there and look at any questions that have come into our portal. Okay, we have a couple of questions.
Evan, "Why have we pursued other avenues to unlock value for shareholders, like new partnership deals, restructuring the company into two, or expanding Technosphere in additional diseases and disorders?" I think what you have seen, Evan, is us go into ralinepag as another opportunity with United. We have had other conversations with partners, and when you think about the amount of time it takes and the money and the resources, many partners either don't have the resources to continue, or they want us to generate the data and then de-risk it and fund that on our behalf as shareholders. We're now at a point in the company where we can fund our own innovation, as you've seen with bumetanide and some other things we've been working on that are not yet public. We do believe Technosphere continues to be a platform technology in the coming years.
I think the other thing we've been trying to pursue is diversification. We looked for an opportunity to purchase a company for many years. We were very prudent and very paused in our momentum of which company we look at and where we could bring value. That is where we came upon scPharmaceuticals. I think we saw in the second half that was a great acquisition, great momentum, and a great opportunity to help patients with an unmet need. On FUROSCIX or Lasix, which has been around for 60 years, it took to reformulate that product to hopefully get people out of the hospital and have decent care out of the home. In fact, new data just came out last week out of the NHS in Europe and London and England, showing that using subcutaneous furosemide gets people out of the hospital and improves people's success.
This is exactly what we're aiming for in the U.S. We believe this product has the opportunity to make that happen. We'll continue to diversify the company. We will continue to focus on shareholder value. We have the two things that we've been waiting for right in front of us with the autoinjector as well as peds. Let's continue to see the execution there and the revenue growth, and that is what shareholders expect and investors need to buy into our stock. Anderson, we have a question on an in-person shareholder meeting. We get this often in email. I just think in today's world, we get more people attending remotely, and we're now a company with three or four sites around the country. Happy to meet with shareholders. We meet with shareholders often at investor conferences.
I'm not sure what an in-person versus a virtual meeting will do, but we're happy to engage any investor at any opportunity. Any other questions? Okay.
No other questions, no.
Okay.
There are no further questions.
Okay. Thank you, everyone, for joining us today for our virtual annual shareholder meeting. We look forward to updating you on our progress at the upcoming investor conferences and earnings calls. It's really exciting opportunities ahead. I want to thank all of our employees who are working tirelessly to get ready for these launches, our board of directors who continue to support the strategy and direction we're moving, and our shareholders for believing in us despite the challenges we face on a weekday and monthly basis. Thank you, everyone. Look forward to keeping in touch. Operator, I'll hand the call back to you.
Thank you. This concludes today's meeting. Thank you for your participation. You may now disconnect.