MannKind - Q4 2023

Transcript

Operator (participant)

Good afternoon and welcome to MannKind Corporation 2023 fourth quarter and full year financial results earnings call. As a reminder, this call is being recorded on February 27, 2024, and will be available for playback on the MannKind Corporation website shortly after the conclusion of the call until March 12, 2024. This call will contain forward-looking statements. Such forward-looking statements are subject to risk and uncertainty, which could cause actual results to differ materially from those stated expectations. For further information on the company's risk factors, please see the 10-K report filed with the Securities and Exchange Commission this afternoon, the earnings release, and the slides prepared for this presentation. Joining us today from MannKind are Chief Executive Officer Michael Castagna and Chief Financial Officer Steven Binder. I will now turn the conference over to Mr. Castagna. Please go ahead, sir.

Michael Castagna (CEO)

Thank you, Valerie. We have never seen a better time for MannKind than we do today. As we look at our future, it's extremely exciting, and I am ever more motivated to ensure we deliver on all key operational opportunities in front of us. As we think about today, Steve and I will go over the operational pipeline highlights, the financial review, and I'm also here today with Lauren Sabella, our Chief Operating Officer, for Q&A. We will drive shareholder value by making a difference in the lives of the patients we serve. We will make over 25 million doses and devices in 2024 and helped roughly 25,000 patients take a MannKind-produced product in 2023, the most in our history. In Q4, we had record revenue for Tyvaso on both royalty and collaboration manufacturing, along with record production on Tyvaso cartridges.

We advanced our pipeline in both the orphan business as well as the endocrine business, and our endocrine business hit its second consecutive profitable quarter. We finished the year in the strongest position we had been in in terms of financial ability, as well as by selling the Tyvaso 1% of our Tyvaso royalty, we're $150 million upfront and $50 million in revenue milestones. Many of you asked, "Could we have sold more? Why didn't we sell more?" The reality is we didn't need to sell more. We wanted to make sure we were comfortable with carrying the level of debt and cash on the balance sheet to control our future. We're very excited about Tyvaso DPI and what it's going to bring to patients and anticipate, hopefully, positive milestones for Tyvaso in the future, and therefore wanted to preserve 90% of that value for our shareholders.

At the same time, we wanted to de-risk on the debt side of our company. We've also restructured our insulin purchase commitment and reduced our near-term cash outlays by $50 million. The EBU will be the foundation for our future launches and currently makes up about 37% of our revenue in 2023. As I presented at JPMorgan in January, our ability to grow double digits for the foreseeable future looks bright when you see in 2023, our total revenue approached $200 million, almost 100% growth year over year. I'm going to spend a few minutes on Afrezza and the EBU because we are at a pivotal inflection point with our future. Innovation takes time, and disruption is even harder. When you think about the weight loss craze today, GLPs were 20 years in the making to what you see today.

The pods in type 1 diabetes, 10 years in the making, and pens took a huge time to convert from vials back in the early 2000s. I believe we can make this business a core pillar of our growth story. When you look at the endocrine business, it grew 32% year-over-year, or $70 million in 2023, and greater than $20 million in Q4, the second quarter in a row of profit contribution, as well as on a run rate of $80 million. We've made a lot of changes in 2023 and delivered, despite those changes, to set us up for a transformation once we see the new data from INHALE-1 and INHALE-3 this year. As I look at the revenue, Afrezza net revenue grew $12 million, or 27% year-over-year.

This is our largest jump in 7 years and is the most we've seen driven by volume alone as opposed to price balanced by historical standards. Several clinical readouts in 2024 may expand our market potential, and I'll talk about those in a minute. One of the questions I get is, "What is different this year than prior years?" Our focus this year is incredibly different. We've been waiting for this moment where we have people, money, and data. Many times, we had 2 out of 3, but not all three. So number 1, we got to maintain our persistence in Medicare and commercial to grow our base business and leverage the $35 insulin copay that currently exists for Medicare and commercial insured. So coverage we know is the number 1 objection. Number 2, we optimized our sales force footprint here in January to build capabilities for the future growth.

And what that means is we were able to reallocate some headcount to create key account managers, reimbursement specialists, as well as virtual and in-person training across the country. We also have new insights from our market research, which I'll share with you shortly, that suggests by executing effectively, we can increase prescriber adoption. And finally is around data and education. We want to focus on KOL development, education at conferences, and publications to elevate the support and awareness, especially among academic centers. Here's some new market research as we go forward called the Emotional Engagement Mindset Model, which is done by a company we've leveraged for market research. This shows a significant shift in perception by the various groups we tested with our new data.

You can see at baseline, just unaided awareness of Afrezza and what people's perceptions were in terms of unattracted, apathetic, attracted, or passionate. By exposing them to our core visual aid as well as some expectations of what INHALE-3 data could read out, you can see we shift almost two-thirds of our key target audiences are attracted or passionate about our future. This is really important because it's the first time we can see this big of a shift from where we started to where we end up with the new data coming. People don't want slow-acting insulin in a world that moves as fast as we do. When I look at the future here on our studies, INHALE-3 and INHALE-1, I'm going to talk a few minutes about these.

We have 60 U.S. sites and KOLs, sites like the Mayo Clinic, the Joslin Diabetes Center, some of the foundations of diabetes treatment in this country. Irl Hirsch is our top-tier thought leader here on INHALE-3 as a principal investigator, and he's done a great job ensuring this trial is dosing properly and enrolling quickly. We have over 300 patients in both of these trials, and both of them are on track to read out this year. On the left side of the slide, type 1 diabetes, INHALE-3 is the largest switch study away from AID pumps. There'll be about 120-some patients in this trial. Half of them will be on MDI. Half of them will be likely on AID pumps as we look at the data. The reason this data set's important is it's utilizing a new dosing conversion upfront to ensure proper efficacy is maintained or improved.

We are also doing meal tolerance tests at baseline in week 17 so we can see how people's dosing may have changed over this time frame. Another thing to remember about this trial is the first time we're enrolling, almost 25% of the patients are a level 7 A1C when they enter. We're also showing you, hopefully, that tight control can remain by switching to Tresiba plus Afrezza, or degludec is the generic name. A lot of people ask me, "What is the goal of INHALE-3?" Our goal is equal efficacy to what's perceived to be the standard of care, including an AID system. No mealtime insulin or AID system has ever beat another system head-to-head. We think this is an important metric that is successful, and if we see a clinical advantage on highs or lows, that's upside to our expectations.

We also plan to use this data to hopefully update conversion figure one in our Afrezza label. We've been in discussions with the FDA since the start of the peds program around how do we update that initial dose conversion. We hope that INHALE-3 will be part of that data set. On the right side of the slide, and you can see, sorry, on the bottom of the slide, the different data readouts. First dose will be at ATTD in March. The 17-week data we expect to present at ADA in June. And the 30-week data will be complete in third quarter and will be presented at a future conference. On the right side of the slide is INHALE-1. This is a pediatric study, and we think this is a watershed moment in order to transform the inflection of Afrezza will be through pediatrics.

When we look at diabetes innovation today, whether it's CGM, insulin pumps, this started with children and worked our way into adults because the patients are more on social media, the parents are more progressive, and the doctors are more progressive. This will be the largest study done on Afrezza in over 10 years. And so far, we don't have the data, but I can tell you the conversion dose has appeared to cause less dropouts relative to our original trials on Afrezza. There's also a meal tolerance test at baseline using CGM. And hopefully, this study will be used to secure pediatric approval in 2025 and beyond. This is how we believe we will accelerate rapid growth of Afrezza, and this will ultimately spill over into adults. The one hangover is still the lungs, and we think it's time to move forward beyond this.

When we look at the data today, we've been on the market 10 years. We've helped tens of thousands of patients. We are building up U.S. KOL support. We have this new data coming out. We would not be going to the children if we were worried about the safety of our product. So when I look at the future and the growth opportunity, we look at four segments of our future. Number one, we're already approved for type 1 and type 2 adults. INHALE-3 will be using a new dosing with CGM and an upfront conversion. We're super excited about this data set as it will also include the head-to-head data I just mentioned. GLPs will continue to be the bolster of the units there in type 2 diabetes.

However, those patients will still need mealtime insulin and will continue to promote Afrezza and V-Go in that segment as there are millions of people who require mealtime insulin over the coming years. However, in order to be a leader in type 1, we need the data from INHALE-3 to set us up for INHALE-1, which is the pediatric segment. Because when we do finally get that data, we know insulin pumps will be the indirect competition when it comes to a doctor, a patient, or a CDE making an educational decision for a patient, they will want to know what Afrezza looks like against insulin pumps. So we started that study with INHALE-3. We're excited to hopefully wrap up INHALE-1 in a few months here. And once we see that data, we will have a one-two punch this year as we wrap up 2024.

And now as people are starting to see the first dose data, we're getting questions on gestational diabetes. We think there's an unmet need there that we want to fulfill over time because there's only two drugs that can be used today: metformin, which crosses the placenta, and slow-acting injectable insulin. And for anyone that knows anyone suffered from gestational diabetes, keeping your time in range really tight is critically important. I'm going to bridge over to the pipeline very quickly. NTM, nontuberculous mycobacterium, with our clofazimine suspension. So some of you may not be aware, but one of the competing products in phase three had a pause last week in enrollment.

And people ask me, "Why am I excited about our program and why am I confident?" Well, the reason we are excited is, 1, when we purchased the product, there was preclinical data showing an improvement in bacterial recovery in the lung model that they used. 2, there's worldwide data. The product is approved today indirectly through a market access program by the FDA and Novartis. So we see worldwide data being generated from patients taking clofazimine here in the U.S. as well as Japan. Third, there's KOL support for this along with guidelines, potentially. And finally, there's no near-term competition for trials now for patients. So as we look forward, we have 100 sites we're going to target across the world. And we see no other option really for these patients to enroll besides the current drug that's on the market, Arikayce.

Here is the design of our phase 3 study called the ICON-1 study, which was designed post our FDA feedback along with the Quality of Life Group there at the FDA. We've taken their feedback. We've incorporated that into this design. It's 120 patients on the active arm and 60 on the placebo arm. We'll do an interim analysis at 50%, and we'll continue to watch enrollment as we saw that the competing program enrolled relatively quickly over the last 6 months of the year last year into this year. That gave us even more excitement for the speed of enrollment that could happen with this trial. We're excited to get this trial going, and we expect to file the IND here in March and kick off the trial in June as we've had a lot of dialogue with the FDA on the trial design.

We expect quite quick approval on the central IRB. It's exciting to us that this will be over a billion-dollar market with only 2 players in the next 5-10 years. We have the potential to be the second approved NTM product. And the market research indicates we will be a potentially preferred option for patients, whether it's because of our favorable safety profile relative to oral clofazimine that's utilized or the toxicities and tolerability challenges that some people face with ARIKAYCE. We also know that we'll have convenient dosing. What does that mean? 28 days of treatment followed by 2 months off followed by 28 days of treatment. So if you're doing well, you'll potentially be treated for 4 cycles a year. That gives patients a large burden back from what they did every single day to where they are.

We also know the current treatments are not highly efficacious and that patients need more options in order to keep this disease in control. It may be a disease that goes away and comes back over time, but it's one that they'll probably live with chronically for a long time. We have an opportunity to expand a brand within a brand as we think about clofazimine in the future. The next quick pipeline highlight I want to talk about is idiopathic pulmonary fibrosis 201. This is going to be known as Nintedanib DPI as we go forward. The reason I'm excited about this program is our 28-day tox data was very clean. We know 80% of these patients die in five years. There's a huge unmet need in this disease state. And Ofev is the market leader marketed by Boehringer Ingelheim.

We have a decreased risk relative to the landscape that has failed in IPF development because we already know this molecule works in IPF. What we do also know is that there's severe GI toxicities, which limits patients' acceptance and uptake and prescriber adoption. There's roughly 15,000 active patients in treatment in this country. We believe bringing a more tolerable product that could potentially be dosed higher will be maximized in value for this population relative to what's out there today. Additionally, our rat bleomycin study on MNKD-201 appeared to mitigate the inflammation and fibrosis comparable to oral nintedanib at substantially lower doses. As we go forward and our IND will be filed, we'll be studying this in MNKD-201 in our next slide.

We'll be studying this in our Phase 1, a single ascending dose, as well as our multiple ascending dose to show can we tolerate higher doses over 7 days. This will be an important study that gets done here in Q2 with data expected to read out in Q3. Our goal is to show lowest GI side effects and safety in healthy volunteers. I want to acknowledge as we go forward the hard work that Steve has done in landing our royalty financing deal as we worked on this for over 6 months. We're in a great position because of Steve's vision and leadership over the last 7 years. Before I turn it over, I just want to acknowledge all the hard work Steve has done for us and our shareholders and our employees. With that said, I'll turn it over to Steve to go over the financials for the quarter.

Steven Binder (CFO)

Thank you, Mike, and good afternoon. I'm pleased to review select fourth quarter and full year 2023 financial results. Please supplement this call by reading the consolidated financial statements and MD&A contained in our 10-K. 2023 was a year of substantial revenue growth for the company in terms of both percentage and dollar growth. Total revenues doubled versus 2022 and reached nearly $200 million. Let's break this down by starting with the fourth quarter total revenues at the bottom of the table. Our total revenues grew a robust 62% versus fourth quarter 2022 and 99% for the 2023 full year period, primarily due to the growth in our Tyvaso DPI-related revenues.

Going back to the top of the table, you will see that TYVASO DPI royalty revenue for the fourth quarter was $21 million, which is a 132% increase versus 2022 and the result of continued growth and use of TYVASO DPI for patients suffering from PAH and PH-ILD. Please note that $2.1 million of the fourth quarter royalty revenue was sold to a third party, and I will review the accounting for the royalty sale in a few slides. Collaboration and services fourth quarter revenue was $17 million, which was an 81% increase over 2022 and was primarily representative of strong TYVASO DPI production volumes in the fourth quarter.

For the full year 2023, Tyvaso DPI royalty revenue was $72 million, an increase of 361% versus 2022, which was primarily due to the increase in patient demand for the product and the start of commercial sales by United Therapeutics late in the second quarter of 2022. Royalty revenue has now become our largest single source of revenue, which allows us to fund and progress our clinical development and product pipeline. Collaboration and services revenue for the 2023 full year period was $53 million, an increase of 90% versus 2022, which was primarily due to the start of commercial manufacturing in the second quarter of 2022 and the increase in production and sales of Tyvaso DPI semi-finished product to United Therapeutics in 2023. Moving down the table to our endocrine business, total endocrine revenues were $20 million for the fourth quarter and $74 million for the full year.

For the fourth quarter, Afrezza net revenue was $15 million compared to $12 million in 2022. A growth rate of 29%, which was mainly driven by higher patient demand with underlying paid TRX growth of 29% year-over-year, a lower gross-to-net deduction as a percentage of gross revenue and price. Compared to the third quarter of 2023, there was a $2 million increase, which represents half patient demand and half increased channel inventory due to wholesalers purchasing an extra week of product in late December. This additional wholesaler purchase in late December will likely impact our net revenues for the first quarter of 2024. For the full year 2023 period, a 27% increase in Afrezza net revenue was mainly related to increased volume from higher patient demand with underlying paid TRX growth of 25%, price, and a more favorable gross-to-net adjustment as a percentage of gross revenues.

Net revenue for V-Go was $5 million for the fourth quarter of 2023. Revenues were 13% lower versus 2022, primarily due to lower patient demand and higher gross-to-nets as a percentage of gross revenues, partially offset by price. V-Go net revenue improved versus the third quarter of 2023 by $0.2 million, mainly due to improved gross-to-nets. For the full year period, the 48% increase is primarily related to the purchase of V-Go on May 31st of 2022, reflecting a seven-month versus 12-month comparative. The next slide shows our revenue growth by source and basic earnings per share on a quarter-by-quarter basis from the first quarter of 2022 through the fourth quarter of 2023. I like to show this graph because it highlights how dramatically our business has changed in two years and how we're executing against expectations.

For the fourth quarter of 2023, total revenues increased 14% sequentially versus the third quarter of 2023 and are up 62% versus the fourth quarter of 2022. Fourth quarter 2023 total revenue of $58 million was almost 5x the total revenues recorded in the first quarter of 2022. Below the graph are our quarterly basic earnings and loss per share. The fourth quarter was the second straight quarter with net income and positive earnings per share. As I stated during the third quarter earnings call, we're in a period where we expect to bounce back and forth between earnings and loss per share as our revenues increase. But we will also be increasing our spending on our pipeline as we move MNKD-101 into a phase 3 global clinical trial and MNKD-201 into a phase 1 clinical trial.

In addition, we will wait to see the results from the INHALE-3 and INHALE-1 clinical trials for Afrezza before deciding whether to increase promotional spend behind that product. For now, we will continue to focus on growing the profitability of the endocrine business unit, which has had a positive contribution for two straight quarters. Moving on to our GAAP-to-non-GAAP reconciliation, I will first focus on the fourth quarter, which is on the left-hand side of the table.

We had GAAP net income of $1 million, which went adjusted for select non-cash items for stock compensation, gain or loss on foreign currency transactions, which is related to our insulin purchase commitment, loss on available for sale securities, a sold portion of the royalty revenue, and the interest expense on the liability for sale of future revenues, which I'll discuss in more detail in a minute, provide for a non-GAAP net income of $7 million versus a 2022 fourth quarter non-GAAP net loss of $11 million. For the full year 2023 period, we ended with a net loss of $12 million. But when adjusted for the select non-cash items, it becomes non-GAAP net income of $6 million, which is compared to a non-GAAP net loss of $78 million in 2022 and $84 million year-on-year positive change.

Now I'd like to take some time to explain the accounting that resulted from the sale of our 1% of our Tyvaso DPI royalty. To set the stage, we sold 1% of our 10% royalty for $150 million plus up to $50 million more if certain net revenue numbers are attained within a period of time ending in September 2027. This puts a third-party valuation on the 10% royalty of approximately $1.5-$2 billion. After we announced the royalty sale in early January, I heard back from investors that we could have done a better job explaining how we'd recognize those transactions in our financial statements and how we got to our accounting conclusions. So let me try again. First, we looked at all of the GAAP guidance, reviewed all similar relevant transactions we could find in the last five years, and then consulted with our auditors.

The conclusion we arrived at, among other things, is that MannKind has a continuing involvement in the generation of Tyvaso DPI revenue through activities to protect the intellectual property of Tyvaso DPI, such as defending the patent estate, protecting the product, and a continuing involvement in the manufacturing of the product for United Therapeutics. Thus, the upfront proceeds recorded as a liability for future sales of royalties, not as revenue. The table on the slide reflects how the accounting works. We record the cash consideration received, net of issuance costs, and a related liability for the sale of future royalties on our balance sheet. To recognize interest expense related to the liabilities, we forecast the future royalties to be received through 2042 and calculate the return that would be needed when receiving a $150 million upfront payment for 1% of the royalty over this time period.

This rate came to just over 11%. In future periods, we will continue to estimate the future royalty stream based on royalty trends, commercial success of Tyvaso DPI, competition for the brand, and other meaningful inputs. The outcome of these future estimates may adjust the prospective interest rate used in determining interest expense and amortization of the liability. Each quarter, we will charge our P&L for non-cash interest expense based on the interest rate and credit the liability. We also recognize 1% royalty as non-cash revenue and reduce the liability by this amount. In addition to the non-cash attributes of this transaction, we also earn cash interest income of approximately $7.5 million annually. The slide shows how the accounting should work for 2024 if nothing changes in our forecast of expected royalties.

The balance sheet would end 2024 with $153 million in cash and $153 million of a liability for the sale of future royalties. The liability balance will increase as long as the non-cash interest expense is greater than the non-cash royalty revenue, which is likely to occur over the next few years. Once the non-cash royalty revenue becomes greater than the non-cash interest expense, assuming that sales of Tyvaso DPI continue to grow, then the liability balance will begin to decrease. Focusing on the 2024 income statement on the right side of the table, we will record non-cash revenue of $10 million and cash interest income of $7 million, offset by non-cash interest expense of $17 million. As discussed on a previous slide, we expect to isolate the non-cash aspects of this transaction in our quarterly GAAP-to-non-GAAP reconciliation of net income and loss.

With over $300 million in cash and investments on our balance sheet as of December 31st, 2023, we want to share our near-term priorities for using the cash to increase shareholder value. First, focusing on our development pipeline, we expect to fund much of MNKD-101 and MNKD-201 clinical trial expense over the next few years through operating cash flow. As these assets advance through clinical trials, we will prioritize their funding. In addition to MNKD-101 and 201, we have two clinical trials for Afrezza nearing data readouts. We will wait to see the results of these trials before deciding whether to invest more behind this asset to grow revenues. In addition, we plan to do the following with our debt. Our MidCap senior secured debt has a balance of approximately $33 million as of December 31st, 2023, and currently carries an interest rate of 8.25%.

We expect to pay off this debt in the first half of 2024 to take advantage of the interest rate arbitrage between debt interest expense and cash investment returns and release our assets from MidCap's security interest. MannKind convertible debt with a balance of approximately $9 million as of December 31st, 2023, is expected to be paid off early in cash or in a mix of cash and stock. By doing this, we would be reducing future shareholder dilution. Our senior convertible debt with a balance of $230 million as of December 31st, 2023, carries a low fixed interest rate of 2.5%, and we do not expect to buy back bonds prior to maturity in March 2026. When maturity arrives, we expect to reduce future dilution by paying off the debt with cash if our stock price is below the conversion price of $5.21.

Additionally, we do not expect to access the ATM. To summarize a very successful 2023, we doubled our total revenues to almost $200 million versus the prior year. Fourth quarter was the second successive quarter for positive contribution from our endocrine business unit. Fourth quarter was the second successive quarter of net income for the company. We sold the 1% interest in our 10% Tyvaso DPI royalty, which values the royalty stream alone at between $1.5-$2 billion, and we ended 2023 with $302 million in cash and investments. 2024 should be another stellar year for MannKind as we are financially primed to drive our commercial and clinical priorities and deliver increased shareholder value. Thank you, and now I'll turn it back over to Mike.

Michael Castagna (CEO)

Thank you, Steve. I appreciate the explanation, all the accounting. I never wanted to know. Now they know I appreciate you. Next slide. MannKind has been around 33 years, and I want to give a special thank you to our founder who passed away 8 years ago on February 25th. The reason that's important is the day I decided to join MannKind, and I'll forever be grateful for Al Mann. He was a special human being who cared about society, our patients, and making a difference. We have the foundation he left us with in 2016, and we built this into a major self-sustaining growth company against all odds. When you look at the history from 2016 forward, we announced our United Therapeutics collaboration. We acquired Qrum, which is now our phase 3 asset with clofazimine, our MNKD-101.

We purchased V-Go, which made our endocrine division more sustainable and brought us a couple thousand new prescribers. Tyvaso DPI has been ahead of all expectations since its approval. As I look forward, we are just getting started. Expected 2024 milestones alone between Afrezza and the study readouts, MNKD-101, MNKD-201, not to mention the Tyvaso DPI, which has two major trials going on in TETON-1 and TETON-2, which I heard this last week were 70% enrolled. Once they finish up enrollment, they'll have 12 months there we should expect to see data from United Therapeutics. Additionally, our team just this day completed the high-speed fill finish line in terms of qualification and will now be going into PPQ, hopefully producing much higher volumes of Tyvaso, out of that line as we exit Q1 going into Q2.

As I look at our future, we have several key value drivers. As you can see, our insiders picked up some stock in the last few weeks, post our board meeting, because we believe we're undervalued and we're very confident in our future. Analysts have expenses in for our pipeline but no revenue in the next five years. We think this is an unfair evaluation of our company given that we do expect to launch clofazimine in the next five years and move NTM I'm sorry, and move the IPF asset in terms of MNKD-201 into patients and then hopefully into phase three by then. When we go back and look at another successful company in time, InterMune, was similarly valued at $800 million at one point, and 18 months later was $8 billion once they got a positive data readout.

Our job is to not react or overreact day to day to swings in the stock market, but to lay out a firm foundation for future growth. And as we look out there, whether it's the pipeline with MNKD-101, every 1,000 patients is approximately $100 million in revenue. MNKD-201, we're going to start patients dosing there, and as you think about IPF, every 1,000 patients is roughly $150 million in annual revenue. And then we get into Tyvaso DPI, which, as you can see, this past year, when you add up the collaboration services revenue in addition to the royalties, we know there's roughly 5,000 patients on Tyvaso DPI. And that's about half of the $250 million in revenue that we experienced this past year. On the endocrine side, we have several major upcoming opportunities with INHALE-1 and INHALE-3, as well as Afrezza International.

V-Go is being managed for improved profitability as we continue to focus on improving our margins by reducing COGS as well as improving gross-to-nets. As we take a step back, we have multiple shots on goal to create significant shareholder value across three commercial products when you think about Afrezza, Tyvaso DPI, and V-Go that are already FDA approved, as well as two assets coming up quickly in the pipeline between MNKD-101 and MNKD-201. We have multiple shots on goal within these assets, and we are completely focused on delivering shareholder value sustainably for years to come. We have several upcoming presentations and engagements at conferences.

I'll be doing non-deal roadshows with Steve over the coming months to get the word out as we feel like MannKind is at the best inflection point with the best team in the industry, cash on the balance sheet, and multiple shots on goal in terms of data readouts to drive future growth. We're super excited about future, and I will stop there, Valerie, to take questions. Thank you again.

Operator (participant)

Thank you. Ladies and gentlemen, if you'd like to ask a question, please press star 11 on your touch-tone telephone. Again, to ask a question, please press star 11. One moment for our first question. Our first question comes from the line of Andreas Argyrides of Wedbush. Your line is open.

Andreas Argyrides (Analyst)

Great. Thanks for taking our question. Congrats on all the progress. Just maybe two for us here quickly. Despite an evolving competitive landscape in PAH and ILD, the Tyvaso royalty puts a $15 billion valuation on Tyvaso DPI. A key component to DPI's advantage is the ease and convenience of a low-resistance device compared with other high-resistance devices. So the question here is, could you elaborate on the differences with the DPI device compared with the competitors and how that plays into DPI safety and efficacy profile? And also, how do you see the DPI device playing a key role in the delivery of nintedanib and IPF? Thanks.

Michael Castagna (CEO)

Andreas, I want to make sure I get that second question. Can you repeat that one?

Andreas Argyrides (Analyst)

Yeah, yeah, sure. So back to the advantages of the DPI device, how do you see it playing a key role in the delivery of nintedanib and IPF, mostly from a delivery and a safety perspective?

Michael Castagna (CEO)

Yep. No, I think that's what gets us excited, right? I'll start with that question first. When you think about our platform, it's the same device being used in the same audience that we're currently moving forward in orphan lung disease that United Therapeutics is also using, right? So the familiarity, the training, all that, and the comfort of bringing inhalation into this patient population with our current technology gives us that much more confidence because most of the powder is our novel excipient, FDKP. So if they can tolerate that in the PAH market, and we know some of those patients overlap with ILD as well as IPF, then being able to show that our powder at 90%-99% FDKP should be able to tolerate it in the nintedanib as we go forward. And so far, the animals, the dissolution and all that looks positive.

We're doing a chronic tox, and we'll have that done by the end of this year. At the same time, we get phase 1. So I think this year, nintedanib should feel like it's even more diverse than it already is given it's a known asset and a known technology. That'll be a positive contribution for there. On the other side of the equation, you were asking me, how do we differentiate our platform? I think our powders are built to fly with our devices. They're going hand in hand. We're not taking a novel powder and throwing it into an off-the-shelf device. I think that it's about that deep lung penetration. It's about the velocity of those powders that are coming out and how consistent and deep lung penetration you're getting across the board. And so I think that's number 1.

Number two, we know that the powder we need is very low because we probably have world records of filling the smallest volume for the 60 microgram all the way up to 64 microgram or higher. So as people want more, they don't need to inhale that much more powder to get additional effect size, which should help on cough, which should help on absorption, as well as just safety. When you think about a lot of FDA had questions on hormones and devices and asthma, how do you use steroid use? These are questions that come up with the FDA. It's really important, right, that there's not excess powder coming around, especially when you get to these narrow therapeutic drugs. You want the proper dose delivered with minimal powder containment happening or powder extraction happening outside of the cartridge itself. So these are all important things that come up.

And I also think patient satisfaction was very high in the trial that UT ran in pivotal. And we also know from thousands of patients we've studied Afrezza in. The device is relatively easy to use from four years old to roughly 80 years old. So those are just the well-known comfort, the dosing, and the consistency of dose will be important factors as we go forward.

Andreas Argyrides (Analyst)

All right. Appreciate that. I'll jump back into queue. Congrats also on all the progress.

Operator (participant)

Thank you. One moment, please. Our next question comes from the line of Olivia Brayer of Cantor Fitzgerald. Your line is open.

Olivia Brayer (Analyst)

Hey, good afternoon, guys. Thank you for the question. Can you talk about how NTM fits into your strategic priorities just as you grow into a more mature company? And there is some competition in the space, although maybe less so these days, as you pointed out. So how should we be thinking about where MNKD-101 could fit into the treatment paradigm? And last question is just, can you remind us on what the timelines are for expected enrollment and data readouts there? Thank you.

Michael Castagna (CEO)

Sure. So I think there's a couple of things to how it fits in the company. The first will be a decision on licensing outside the U.S. So we'll run the trial in the key countries where NTM exists, but we may choose to partner out. Japan, for example, where we saw Insmed went independent. We haven't made those decisions. We don't have to make those decisions. We are looking for partners and talking to partners. But it's up to us, and we're a little bit in control of that process there. In terms of how it fits into MannKind, I think there's core capabilities that we have today around reimbursement support, patient training, and how do you treat a specialty product from distribution, things like that that we have that will be applicable to the NTM space.

Then when you think about where it fits into the treatment regimen, there are two points there. Number one, we're going after the refractory patients first. And in that population, right, the only drug approved is ARIKAYCE. And we think there we have a significant clinical advantage as well as a convenience advantage that we should be able to displace or grow that market opportunity very quickly as we enter it. The other part is we are actively working on a dry powder version of clofazimine. And we expect that that will be used for a drug-naive population so that it can be used earlier in lines of treatment. So we do intend to cover early and late stage.

That's one of the benefits of being where we are as a company is when that opportunity presents itself and we choose to want to fund maybe a second trial at that point, we can decide. Part of that will be how fast is the phase three enrolling on the refractory population? If we look at AN2 as the lead example, right, they got about 180 patients in 15 months. So that's about what we need. So if you really think about where we are today, 15 months from now, we could be fully enrolled. But we only need half of that population to do our internal analysis. So we hope to have that internal analysis sometime in the second half of next year. Then we would just be waiting for the full patient population to get there in order to hopefully file on 6-month data.

That's our goal. It's a primary endpoint of six months. When you think about the grand scheme of life, we're not that far away from hopefully kicking this trial off here in second quarter. More importantly, we're sitting here next year at this time. We should be quickly enrolling halfway if everything goes as planned.

Operator (participant)

Thank you. One moment, please. Our next question comes from the line of Steve Lichtman of Oppenheimer and Company. Your line is open.

Steven M. Lichtman (Analyst)

Thank you. Evening, guys, and congrats on the progress. Just level setting into ATTD, what is the data exactly that we're going to see there? I know we'll see the 17-week at this is on INHALE-3, excuse me. I know we'll see the 17-week at ADA, but what's the anticipation at ATTD?

Michael Castagna (CEO)

Yeah. So we have a presentation there by Irl Hirsch, which will be the first dose on the meal tolerance data. Steve, what I think that will allow us is the opportunity to obviously have an Afrezza on the podium there in front of everybody. But I'm sure Irl will be presenting some of the data and rationale why an Afrezza deserves a more fair chance in treatment. And he'll show that first dose data. And that'll be the primary focus there. As you know, it's a technology conference with lots of innovation. And that's really a type 1 community that comes from there. I think the other part of this is starting to talk about, do you go to Europe, for example? Is there another opportunity once we see the full dataset to expand to other markets in a meaningful way? So we're there for that reason as much as anything in terms of showing the data and meeting global thought leaders.

Steven M. Lichtman (Analyst)

Got it. Okay. And then just on the endocrine business in general, I know you've been balancing growth and profitability. And you noted in your prepared remarks, optimizing the sales force footprint. So I guess, are you been reducing the footprint, being more strategic there? You talked a little bit about what you've been doing. And then what are the range of commercial investments you would consider assuming positive outcomes in INHALE-3 and ICON-1? Would you add more to the sales force? Would it be something else? Thanks.

Michael Castagna (CEO)

Yeah. I think on the sales force footprint, you have to rewind back 18 months. When we bought V-Go in May 2022, we dedicated roughly 20-25 FTEs to that brand alone. One, it was on a 2-year decline not being promoted. We wanted to stabilize it. Two, we didn't want to disrupt the Afrezza field team. So we held overlapping expenses for quite a while in both of those businesses. Really, our focus going into July and January this year was a 2-step process around integrating V-Go into our commercial footprint on Afrezza. Then the second step was integrating the sales force into one voice, one team. That took place in January of this year. There were some headcounts that were freed up as a result of that process.

We reinvested some of those headcounts into the field reimbursement support, the training, and the key account managers. We think the key account manager is critical. As we go into pediatrics and academic centers, that's not where Afrezza has been widely adopted. The first step is getting the key account managers to make sure we stabilize those big accounts. Then the second step will be hopefully filtering in some reps underneath them where they can maintain accounts or grow accounts day to day while those key account managers take on the next group of accounts and get us ready for peds. We have a multi-step process here. It's not going to happen overnight. The first step was getting the one field footprint, one voice with one team, and one new marketing campaign, which we're actually rolling out this week.

So I think the team will see that. We've invested a lot in training. We have a couple of field trainers now. And that's going to be the number one focus this year is, can we grow faster than we have been with the current footprint and the current infrastructure we put around that footprint? And if that model is working, I think we'll have conviction to go ahead and expand that model further. We can easily add 50-100 more people. I wouldn't really do that until we saw groundbreaking data and that some of our current model was working with KOL support. I think the number one thing with the data will be the KOL support around that data because we have to be able to penetrate the academic centers, which are very pump-based.

I think that the pump data within INHALE-3 is going to have to hold up in every objective way in terms of reducing highs or reducing lows or improving A1C or time in range. So if you ask me what does the data need to look like, it's got to be very compelling for us to be willing to spend money. And that compelling investment will be commensurate with the data. We're not going to. We've been through Afrezza a long time. We were very excited about the data. We loved the product. But we have to be objective around our investments and our ability to drive success. And I think the data is going to help support that.

Steven M. Lichtman (Analyst)

Understood. Thanks, Mike.

Operator (participant)

Thank you. One moment, please. Our next question comes from the line of Gregory Renza of RBC Capital Markets. Your line is open.

Anishan Nikhanj (Analyst)

Hi, Mike, and team. It's Anishan for Greg. Congrats on the quarter, and thanks for taking my questions. I just wanted to parlay some questions on INHALE-3 there. How should we be thinking about clinical bars for HbA1c over the 17-week period in June? And then just considering real-world translatability of the trial design, maybe if you can just remind us on the foreseen pushes and pulls for getting patients to switch between injectable insulin or pumps to Afrezza. Thanks again.

Michael Castagna (CEO)

I think the first question I have was kind of the non-HbA1c margin, maybe an INHALE-3 between the two arms. I think that's a 0.4%, which was consistent with our pivotal trials with type 1. So that was, those trials were done with a different conversion. So we're hoping one of the things we saw in those trials was we got to the right dose. It just took 12 weeks. We're hoping by starting at a better dose upfront, we have 12 more weeks of benefit. We saw the other part last year, if you may or may not recall, we did a small study called ABC, which was a pilot trial on 25 patients to show, could you switch off an insulin pump? How do you adjust the basal? What happens over the 12 weeks of that study?

That study gave us a lot of insights on things we had to correct for this larger trial before we spent the money. For example, one site titrated basal very well. The other site, we learned that you could be a little more aggressive in their basal titration. And so those are the types of things we tried to get more guardrails around in this trial to ensure proper titration, proper conversion. And obviously, doctors know how to use the insulin pumps. And so that was the other thing we saw. And the original trial was they knew how to manipulate a pump very well because these doctors use pumps all day long. Where Afrezza was new to them, they didn't know how to use it to its advantage in terms of dosing and follow-up dosing if necessary.

So we kind of feel pretty good about the trial design, the controls within the trial. So now we just have to wait for the data. So that gives you some perspective there. So we didn't design it for superiority. Those will be secondary endpoints that we'll watch out for. And then your second question around how do you think about this in the real world of existing with pods and pumps and physicians? And I think this comes down to patient motivation. At the end of the day, I think we will have KOL support. I think we will continue to see guideline support. We saw some updates this year in the standards of care for Afrezza. People are starting to understand the lower rates of hypoglycemia, the better time in range.

And they're seeing they want a real-time acting insulin as they've kind of adjusted every AID system and pumped together. What's next? And what's next is really tightening control even further. And we're the best tool to help that. So that's a lot of what we're talking about is how do we look at data on Afrezza on top of pumps potentially? We know that's an FDA challenge. We're also thinking about GLPs. And if you still have mealtime popping on GLPs, do you add an Afrezza to those populations? So we're starting to look and say, if we were to get positive data on INHALE-3 as an early readout, and we anticipate INHALE-1 will look good, then what's the next leg up that we should really start exploring for more continued opportunities for Afrezza? If you think about it, it's the pump market. It's the pediatric market. It's the gestational diabetes market, GLP market. There's a lot of niche areas that are quite large that we think this brand can grow pretty rapidly over the coming years relative to where it's been the last five years.

Anishan Nikhanj (Analyst)

Great. Thank you so much.

Operator (participant)

Thank you. One moment, please. Our next question comes from the line of Oren Livnat of H.C. Wainwright. Your line is open.

Oren Livnat (Analyst)

Thanks. I got a couple one-on-one questions. Can you just help us better understand how you arrived at the Pivotal study sample size and powering? What's that based on? And with regards to the PRO endpoint, I guess since that's a new subjective endpoint in the space, what is the bar there? What does that need to look like to affect the competitor to review? And I've got a follow-up. Thanks.

Michael Castagna (CEO)

Yeah. Oren, these are two great questions. And I think it's the biggest challenge to developing products for NTM. And it's why I think you're going to see continued lack of investment because you have to either have enough capital to go through with it in the case of Insmed, which spent many years building out this space and working with the FDA, as well as the patient communities. And we know that the physician KOL population really wants clofazimine. We know the patient population really wants clofazimine. And even the FDA, I will say, has been nothing but collaborative along this whole journey for five years and going back with Qrum. So I think the market forces are aligned to help support us with the winds in our backs to push us forward. And then you get into risks of running these trials.

I think the reality is there are risks in this population. Given the efficacy on clofazimine, we estimated about, I think, a 20%-30% effect size delta between us and placebo. That's going to be the interim analysis to see, are we on track for that? If not, we might have to increase the sample a little bit. That's number one. The second part was the PRO. We went back and forth with the FDA for years, not just months, on the PRO endpoint, the PRO division, and the feedback from the PRO division for two reasons. One, we weren't comfortable running a placebo-controlled trial given that you can pretty much know what the active arm is. We think that makes the PRO a difficult tool. Therefore, we tried to make it a secondary endpoint.

The FDA was insistent it should be a primary or co-primary endpoint. And so we went round and around. Long story short, we landed where we did, which is a co-primary endpoint with the understanding that this is a little bit of a risky endpoint, but that they agree we've done the best we can to create the baseline measurements and the improvements in those key measurements that we've aligned to with the FDA and that the efficacy is going to have to matter in terms of sputum conversion as much as the PRO tool by itself. And so just like I know I listened to Insmed's call, I mean, what they're going through with the FDA, we've had a lot of those questions. We've worked with them. We've gotten a lot of their feedback already incorporated into our trial design. So now it's about the data.

And then what happens with the data and how you analyze that data once it comes in will be really important. But again, we'll work very closely with the FDA as I think they understand where we are. They understand the pros and cons. And rather than keep debating it, we thought it was more important to get the data and help get this drug across the finish line.

Oren Livnat (Analyst)

Okay. And just so I'm clear, you're going based on some clofazimine experience efficacy-wise. And are you assuming an improvement on that with your powering assumptions, or are you being conservative on that?

Michael Castagna (CEO)

No. I think when you look if we were going after naive patients, we'd think we'd see a much higher efficacy rate. But because we're focused on our factory, we think it'll be a little less obvious in naive patients. And I think you saw that in the inhaled ARIKAYCE data out there. There's only one study to really judge NTM endpoints on. And that's ARIKAYCE. And so I think when you go back in their development program, they had a 20%-30% delta between the control. And there isn't. I'm not sure they had a placebo. I have to go back and double-check the data.

And so that's some of the work that we were going back and forth on: incorporating the placebo could have a placebo effect and how much more do you have to be and how do you power a trial with that potential risk. And that's a lot of going back and forth with the FDA. So we've done the best we can. We'll have an interim analysis. We think that's the most important aspect that we will get to in this trial. But assuming that's on track, then we feel very good about wrapping up this trial to bring this to patients very quickly.

Oren Livnat (Analyst)

All right. Then just with regards to the Tyvaso DPI situation, we're seeing a lot of headlines with regards to potential competition and lawsuits. I'm sure you couldn't or wouldn't comment directly on anyone else's litigation. But if you are willing, I'm curious if we're able to comment on whether your orders coming into this year and your efforts at inventory or manufacturing capacity expansion reflect, I guess, any possible assumptions or risks around competition. Are you potentially waiting to do anything, or is it pedal to the metal, so to speak, on that front?

Michael Castagna (CEO)

Yeah. On the Tyvaso DPI, I mean, we are making as much as we can around the clock. Nothing's slowed down there. We know we want to build up inventory as well. So between the demand and the current amount we can manufacture, there's no slowing down where we are with Tyvaso DPI. In terms of a competitor coming, I mean, we've been hearing about this for years. And whether it was the higher dose, it was the indication. Everyone's been doubting us about, "Is this going to get approved?" When we did get approved, then you're going to have ILD. We got ILD. We've been very honest with the market ever since this drug was under review. And everything we've said has come true, right? We said we would expect ILD. We got ILD. We said we manufactured. We've manufactured. We said it would have a nice conversion.

It's had a better conversion than anyone expected. So from my perspective, Tyvaso DPI has delivered on all parameters above and beyond expectations despite an under-forecasted launch, which put a lot of pressure on MannKind. And we did not miss a beat to make sure every patient had every day supply. And we did a lot. Our team worked incredibly hard last year to make that happen. And we had record production in Q4. And we'll have hopefully equal record production in Q1 and even more production in Q2. So if you look at their story, after ILD is their differentiator for some reason. And I'll be honest, if a patient can't tolerate a dry powder for ILD, I don't see how they're going to tolerate theirs, which has three or four times more powder, if I recall. So it's really about the patient tolerability. It's about the titration.

It's about the powder load. And it's about how you coach a patient, train a patient. All these are really equally important things. And anytime you launch a new drug, you find things out as you go along, and you modify, and you go forward. And that's pretty much what I think I hear UT doing is Tyvaso DPI strong. It's doing great in ILD as much as PAH, from what I heard from their call. And our conversations with UT continue to be very positive. I did want to mention another thing, Oren, is Japan so far is okay with the sputum conversion. So we'll do one trial on MNKD-101 for clofazimine in terms of US and Japan. It'll be one global study. But we'll cut the data two different ways, one for Japan, for sputum, and dual primary for the US or co-primary.

So that'll be an important aspect that we did struggle with the FDA saying, "Why are you the only country in the world that wants this sputum plus PRO where we don't have the same demands yet in other countries around the world?" So that's why I think sputum, you still got to kill the bug at the end of the day. And I think that becomes king in this disease. And can we do that really well is the question. The PROs will work out. But when you look at the labels of PROs, they're not really strong claims at the end of the day. So I still think efficacy is going to matter in terms of sputum conversion.

Oren Livnat (Analyst)

Okay. And I look forward to talking to Steve some more about this accounting.

Michael Castagna (CEO)

I'll stay out of that conversation.

Oren Livnat (Analyst)

Yeah.

Operator (participant)

Thank you. One moment, please.

Michael Castagna (CEO)

Thank you, Oren.

Operator (participant)

Our next question comes from the line of Thomas Smith of Leerink Partners. Your line is open.

Thomas Smith (Analyst)

Hey, guys. Good afternoon. Thanks for taking the questions. Let me add my congrats on all the progress. Just a couple on Oren. I guess first on MNKD-201, the inhaled nintedanib program. Can you just walk us through your expectations for the phase one data in Q3 and how quickly you think you could turn this around and advance it into a phase two trial on IPF patients? Then just remind us how you're planning for clinical supply and scale on 201.

Michael Castagna (CEO)

Sure. On the phase 1 study, because it's a pretty quick study, we actually were going to do IPF patients. It was the FDA who pushed us to consider healthy volunteers. So we actually switched from, I'll say, IPF patients to healthies, which saved us a lot of time and money. So that's number 1. So that turnaround time should be pretty quick in terms of wrapping up phase 1 and filing and end a phase 1 meeting with the FDA, hopefully by the end of the year. And then we're having good discussions internally. We just hired a new gentleman, Dr. Wassim Fares, who will be pivotal in leading our development program beyond phase 1 for 201. And we're having good discussions internally. For example, do we do a 1B study to get data sooner in parallel?

Why do we continue to wait to kick off the trial for the next phase? Is it a 2 study going into a phase 3? So that work is happening as we speak. And I don't want to prematurely guess where we land. But just like clofazimine, where we push to not do a phase 2 trial, one could argue that that's a little risky. At the same time, we know these drugs work. We know the approximate dose we're trying to go after. And we know that that dose has produced a signaling effect that we expect. So in the case of 201, we actually want to dose higher. And that's where we need the chronic toxic data in Q4 to help support that higher dosing. And assuming a patient can tolerate that higher dose, and we think that's going to be one of our clinical differentiators for 201. That'll be the things we look for in the trials. Can we dose higher? Is it tolerable? And do you have any of the GI side effects that we see with the oral formulation?

Thomas Smith (Analyst)

Got it. That's helpful. And then just on the pipeline strategy and the priorities here, obviously, you have a lot on your plate across the inhaled studies for Afrezza and the clofazimine and the 201 programs. But now that you have the financial flexibility, I'm just wondering if you could talk about how you're thinking about balancing external business development opportunities versus advancing sort of the internally derived candidates out of your platform.

Michael Castagna (CEO)

Yeah. No, that's a great question. I think the team is bursting at the seams on everything we're doing today. And the good news is we have a great team who's working extremely hard to make sure we get these INDs in, to get the INHALE-1 and INHALE-3 study wrapped up. And so from a financial flexibility, people don't realize we probably spend, don't quote me in exact numbers, but over $30 million between INHALE-1 and INHALE-3 between people and trial costs. So those trials are wrapping up this year, going into next year. As you think about clofazimine, there'll be a little bit of overlap with the 101. But these other trials wrap up. And so you kind of see that phased in.

People also miss that we have been funding tox trials and other datasets in R&D over the last couple of years on 101 and 201 as well as 501. There's been other investments in R&D that aren't as transparent because we don't talk about them as much. Again, some of those are wrapping up. Those extra funds will be used to fund the phase 3 trial. I think we have the financial flexibility to ensure if we can't fund it out of cash flow generation that we are today, that we have the cash on the balance sheet if we needed to. Our goal is to continue to run the company lean like we have been and not get too far ahead of our skis until we continue to show consistent delivery as we go forward. Steve, I don't know if there's anything you want to add there.

Steven Binder (CFO)

No. I think the other original question was also around BD versus internal. I think you're exactly right. We're going to focus in on the internal priorities that we have. And if opportunities come along, we'll certainly assess them. But the focus will be internally first.

Michael Castagna (CEO)

Yeah. And on the BD side, we get lots of inbounds these days. We're just busy. And so if we see something compelling, we'll look at it. But we're not actively trying to pursue anything. We want to work with what we have and maximize the value of what we have on our plates right now.

Thomas Smith (Analyst)

Got it. That makes sense. All right, guys. Thanks for taking the questions.

Michael Castagna (CEO)

Thank you.

Operator (participant)

Thank you. One moment, please. Our next question comes from the line of Anthony Petrone of Mizuho Group. Your line is open.

Anthony Petrone (Analyst)

Thanks for squeezing me in here. Congrats on strong results. Also, condolences on Alfred Mann passing to the team. Maybe, Steve, a couple on Tyvaso, just the royalty agreement, just high level. Why was 1% sort of the right number? Oren's point, there's potential competition. So what was the calculus on settling on 1%? And is there an option to further monetize Tyvaso royalty under a scenario maybe where you want to fast-track 101 and 201 or even add to the portfolio for future growth investments? Would you consider monetizing the royalty further as a source of funds? And then I'll have a couple of follow-ups on diabetes for Mike.

Steven Binder (CFO)

So Tony and Steve, so what we did is we looked at what the value was for the Tyvaso royalty in a very competitive environment. We had originally over 25 different purchasers come to the table. And we wanted to keep a vast majority of the royalty to MannKind. So we thought 1% was right to get to about $300 million on our balance sheet, which would fund not only our pipeline but put us in a good position to fund the convertible debt when it matures in 2026. So yes, we can further monetize the royalty if there was a need for it. But we don't expect there to be a need for it at this point in time.

Michael Castagna (CEO)

And Steve, I'll just add two things, Anthony, to your question. The thing that drives royalty valuation is interest rates and the calculation you're using for expected interest rates. And so over time, if interest rates come back down, the overall value of this royalty may go up even further, even if the sales came off a little bit of trend for some reason. But we think that when we started this process, the royalty rate was not transparent to the public when you look back in June, July of 2023. And we wanted to bring value to our company around what is 10% of this royalty worth because we thought we undervalued. And that 10% felt the right way to demonstrate that clearly to investors. In the meantime, and we were midway through that process, UT disclosed the royalty.

So we didn't have to kind of work around that issue, number one. And then number two, the interest rates are high. And that does create a bigger discount factor into that future cash flow. So those are things going in our favor, hopefully, over the coming years. And the thing about a competitor coming, we know there's about X% converted from nebulizer to DPI. However, if there was another competing product out there, that may help drive more adoption and earlier adoption of DPI, which indirectly may help us, right, as you think about the future. So we're pretty bullish on DPI and whether there's one or two players out there. It only helps more patients that can hopefully use the product more in earlier lines of treatment as well. So that's kind of how we looked at it. We think MannKind indirectly benefits as more competition does come.

Anthony Petrone (Analyst)

Appreciate that. Just on INHALE-3 and INHALE-1, just from a combined outlook there for Afrezza when you think about using Afrezza with automated insulin pumps and then the pediatric indication, just to kind of level set again from the MannKind standpoint, how it's looking at those two opportunities from a market expansion standpoint for the product and actually which of the two indications are you most excited about? Do you think you get faster traction in pediatrics, or would it be in the combination use? Thanks again, and congratulations.

Michael Castagna (CEO)

Yeah. No, thank you. I think the challenge with adding your Afrezza on top of pumps, besides the FDA—I'll just put that out there—is really the need that a patient sees. And are they always going to carry all this extra supplies with them? And do they use it on special occasions? Do they use it when they get home? It's not a full-time patient when you think about that value. And that's one of the things I think I've seen when people used to criticize our refill rates. Well, we knew roughly 20%-30% of our Type 1s use Afrezza intermittently, which kind of hurts your refill rates, right? And then we know Type 2s are not as compliant as we want to be.

So that's why it's so important to make sure that we are a front-and-center choice for patients who have mealtime control or want to improve their A1C as we look out there. Can we improve A1C? Can we improve time and range? That's what we're hoping to see with these new trials versus when we got approval, it was just to show that the drug was as good as a standard of care. And we think that's good enough for peds approval. But to cause an inflection, right, we want to show that hopefully, we're improving something on the product. If you ask me which is going to be more critical, I think inhaled one will be the study that causes Afrezza to become the next standard of care.

What I mean by that is, look, can we grow faster by putting more people out there, more marketing, more advertising? Absolutely. I think we can. Is it going to be an inflection point that looks like a rocket? I think it's going to take another launch into a new market. And the good news about kids is there's only about 500 doctors in the country that are meaningful pediatric endocrinologists. And they're mostly academic centers. And they're mostly about 40-50 centers in the country. And when you think about the study, it's only 40 centers in the U.S. So we are covering the majority of the key academic centers in this trial. So they will have firsthand experience once the results are unveiled or finalized, at least. And so we kind of really made sure, could we have gone faster by making it a global trial? Absolutely.

But we thought in order to have a major inflection, you better have the right experience with clinicians in the U.S. And that's really what we're doing. Unfortunately, we could not go against pumps in that trial. We wanted to, at the time, switch off insulin pumps and include them. The FDA would not allow us. And that's one of the reasons we kicked off INHALE-3 is we felt once we did the ABC trial, it was safe to switch people off insulin pumps. And even the FDA agreed at that point that we could add that to the trial. But we thought by the time we change INHALE-1 and get all that through the IRBs, it wasn't worth the distraction. So we feel very good about where we are on a one-two punch with INHALE-1 and INHALE-3.

Anthony Petrone (Analyst)

Appreciate that.

Operator (participant)

Thank you. I'm showing no further questions at this time. I'll turn the call back over to Michael Castagna, CEO, for any closing remarks.

Michael Castagna (CEO)

Thank you, Valerie. Thank you all for the analysts coming in. Look forward to seeing, hopefully, a couple of you at ATTD. Also, we'll be on the Non-Deal Roadshow, hopefully, in some key cities meeting with our investors. And just want to say thank you to everyone. It's been a great year so far. We're super excited. Everything's off to a great start. And we're looking forward to making 2024 another record-setting year. So thank you again for everything. And Steve, and Dave, and everything else, thank you for all the work everyone's doing. Have a great day.

Operator (participant)

Thank you. Ladies and gentlemen, this does conclude today's conference. Thank you all for participating. You may now disconnect. Have a great day.