MannKind Corporation (NASDAQ:MNKD), a biopharmaceutical company, reported a strong second quarter in 2024 with record revenues of $72 million, marking a significant increase from the previous year.
The company's financial results were bolstered by the performance of its lead products, including Tabesa DPI and Afrezza. Despite a GAAP net loss of $2 million, mainly due to an accounting charge from early debt repayment, the company showcased a solid balance sheet with $262 million in cash and investments. MannKind emphasized progress in their drug development pipeline, with several key milestones expected in the upcoming quarters.
Key Takeaways
- MannKind Corporation announced record Q2 revenues of $72 million, a 49% increase year-over-year.
- The company reported a GAAP net loss of $2 million, with non-GAAP net income at $14 million.
- Afrezza and Tybeso DPI were significant revenue drivers, with Afrezza experiencing a 20% growth.
- Clofazimine inhalation suspension and nintedanib DPI are progressing, with results expected soon.
- MannKind plans to continue deleveraging and aims to reduce shareholder dilution.
- The company believes it is undervalued and highlighted a strong intellectual property landscape.
Company Outlook
- MannKind anticipates several milestones, including IND submissions and data readouts for INHALE-1 and INHALE-3.
- The company is focusing on the development of their 201 program, with a Phase 2/3 trial design expected to be presented to the FDA in Q4.
- MannKind is optimistic about international expansion opportunities for their diabetes business.
Bearish Highlights
- The company faced a net loss of $2 million in Q2 due to an accounting charge from early debt repayment.
- V-GO revenue declined by 7% due to lower demand as the company prioritized Afrezza.
Bullish Highlights
- Record revenues were driven by strong performance of MannKind's products, particularly Afrezza and Tybeso DPI.
- The company reported nine consecutive quarters of revenue growth.
- MannKind highlighted their sufficient manufacturing capacity for Tybeso DPI, ensuring no anticipated limitations if TETON is successful.
Misses
- Despite overall growth, the company reported a net loss for the quarter, attributed to non-operational financial activities.
Q&A Highlights
- CEO Michael Castagna discussed the importance of balancing efficacy, speed, and tolerability in drug development.
- The company is considering multiple trial designs to bring drugs to market efficiently.
- Castagna expressed confidence in the company's future and acknowledged the support of employees and shareholders.
MannKind Corporation's second-quarter earnings call revealed a company on the rise, with strong revenue growth and a pipeline full of potential. The company's focus on its endocrine business, particularly Afrezza, has paid off with increased revenue.
MannKind's development of new treatments, such as the clofazimine inhalation suspension and nintedanib DPI, shows promise with expected results and progress in patient enrollment. The company's strategic financial management, including deleveraging and reducing shareholder dilution, positions it well for future growth.
With a robust intellectual property landscape extending into the late 2030s and early 2040s, MannKind is poised to innovate and improve its product offerings, potentially leading to increased market value. The upcoming milestones and data readouts are anticipated to further bolster the company's standing in the biopharmaceutical industry.
InvestingPro Insights
MannKind Corporation (MNKD) has experienced a notable financial journey as of late, reflected in its recent performance and strategic positioning. According to InvestingPro data, the company's market capitalization stands at $1.36 billion, illustrating a substantial presence in the biopharmaceutical market. This valuation comes in the wake of a significant revenue increase, with the last twelve months as of Q1 2024 witnessing a remarkable 74.92% revenue growth, signaling strong market demand for MannKind's products.
The company's Price/Earnings (P/E) ratio, a key metric for investors, is currently high at 156.72, suggesting that investors are expecting high future earnings growth. This is further supported by an InvestingPro Tip indicating that net income is expected to grow this year. Additionally, MannKind's gross profit margin stands at an impressive 70.99%, underscoring the company's ability to translate sales into profits efficiently.
Despite recent volatility, with the stock taking a significant hit over the past week, MannKind's overall performance over the last six months shows a large price uptick of 46.06%. This level of growth may catch the eye of potential investors looking for companies with strong momentum.
For readers interested in a deeper analysis, InvestingPro offers additional tips on MannKind Corporation, providing a more comprehensive understanding of the company's financial health and future prospects. There are 12 more InvestingPro Tips available that delve into various aspects of MannKind's financials and market performance, which can be accessed for those who wish to explore beyond the surface-level metrics.
Full transcript - MannKind Corp (MNKD) Q2 2024:
Operator: Good morning and welcome to the MannKind Corporation Second Quarter 2024 Financial Results Earnings Call. As a reminder, this call is being recorded August 7, 2024 and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call and available for approximately 90 days. This call will contain forward looking statements. Such forward looking statements are subject to risks and uncertainty which could cause actual risks to differ materially from those stated expectations. For further information on the Company's risk factors, please see the 10Q report filed with the Securities and Exchange Commission this morning, the earnings release and the slides prepared for this presentation. Joining us today for MannKind are Chief Executive Officer, Michael Castagna and Chief Financial Officer, Chris Prentiss. I'd like to turn the conference over to Mr. Castagna. Please go ahead, sir.
Michael Castagna: Thank you. Operator. Good morning everyone excited to be here, calling in from Danbury, Connecticut today, and joining me is Chris Prentiss, our Chief Financial Officer. Today we'll go over our traditional operational and pipeline highlights, quick financial review by Chris, with some closing remarks by myself, and we'll move to Q&A. Let me begin by talking about some of the second quarter 2024 highlights. First, we had record revenue on Tabesa DPI, between manufacturing and royalty revenue coming in. Second, clofazimine inhalation suspension is well on its way, with fast track designation by the FDA, as well as several sites now activated and ready for patient enrollment. And thirdly, nintedanib DPI is well under its way, with results expected here in Q4 along with chronic tox, we're now on our third cohort of single dose patients, anxiously awaiting to move to the MAD section of the study shortly. In our endocrine business, we had second quarter revenue with $20.8 million driven by Afrezza I'll talk about that shortly. INHALE-1 top line results for pediatrics is expected here in Q4 and we're excited for this pivotal moment in our history to unveil these results. And then the third part of endocrine is INHALE-3. We met at its primary endpoint 17 week data were present at ADA and were very well received and we're coming up on our 30 week data readout here in the second half, and implementing our ADA post success plan. For financial results, record revenue for the company of $72 million of 49% with a GAAP net loss of $2 million and non-GAAP of $14 million that Chris will talk about shortly. We ended the quarter with a strong balance sheet. We continue to delever the company and reducing dilution to shareholders by paying down demand convertible debt and cash in stock, as opposed to stock only. Now, let me talk about clofazimine inhalation suspension. We look at NTM as an opportunity with two players over the coming years. Our case had great data of read out in early stage, and they continue to penetrate the markets in Japan and the U.S., as we look at the refractory population being about 10%, 15%, 20% of this market. We see this as a very large opportunity to bring a new entry that can be more convenient with really good lung coverage here in the U.S. as well as Japan. Let me talk to you for a second about our Phase 3 design. The key attributes of this product are number 1, 28 days on-treatment with 56 days off-treatment what that means is a patient will have one copay for the 28 days, followed by two months off because the drug has a long half-life. We believe it's really important to get deep lung penetration in this disease, as the macrophages are deep in the lungs, and they'll take the clofazimine in and because of the half-life, it will take about two months for it to return back to baseline. We see that same thing, with month four coming on the treatment, and then month five and six off-treatment. The primary endpoint of the study will be six months, and we're looking at a dose of 80 milligrams of clofazimine and a 2 to1 randomization. We will have an interim analysis after the first 100 people are enrolled, and that will decide whether the trial should be larger to make sure we hit our endpoints, or it's sufficiently staffed to reach the primary endpoint. The co-primary endpoint in the U.S. is sputum conversion and patient reported outcomes and the primary endpoint for Japan has been aligned, and that is sputum conversion only. We also have orphan and QID designation, along with other IP giving us a minimum of 12 years exclusivity. Japan and FDA have aligned to a single trial, and we're also considering creating an expanded access program. We'll keep you posted on that. On 201, as you see, this market, while it is crowded in terms of development, there are very few options on the market for patients. We're excited of what we see from United Therapeutics (NASDAQ:UTHR) and TETON 1 and 2 reading out next year for Tyvaso but more importantly, this is on the backbone of OFEV as the market brand leader in IPF. And we believe, while that's a phenomenal drug and it's helped 1000s of people live longer, we also believe there's an opportunity to enhance the quality of life that people experience when going on OFEV and that's really our main focus here as we look at this opportunity, how do we bring potentially improved tolerability relative to GI side effects, specifically that occur with OFEV where 50% of the people traditionally drop off treatment because of GI side effects alone. We also believe that we can dose, hopefully a little bit higher, directly into the lungs and get higher lung concentrations and this is really our focus here on this product is, can we dose appropriately and tolerable? And does that show an improved in GI tolerability? The Phase 1 data readout in chronic tox are expected to both come in here in Q4 and we will then file a meeting with the FDA to move this to a Phase 2/3 design in 2025. Now moving on to our endocrine business. Year-to-date, revenue of $39.5 million, predominantly driven by Afrezza, I'll talk about in a second. V-GO was deprioritized in Q1 as you may recall, and we restructured the field team so that we've had a different business model coming into the year and you'll see some of that result here as I talk about our script growth. Afrezza Q2 sales alone over the prior year grew 20% to $16.3 million. Moving into prescriptions you can see Q1 versus Q2 8% NRX growth leading to 5% TRX growth, quarter over quarter, the NRX's are the leading indicator what to expect three to six months later. It's nice to see that the NRX change is paying off in TRX, and we hope to continue to see the type of growth as we go into Q3 and Q4 this year. As you may not have read our readout on ADA with INHALE-3. This was presented at an oral presentation by seven world thought leaders. The sub-analysis found several key attributes to this trial. Number one, inhaled insulin achieved a target A1C than seven in 30% of participants versus 17. Additionally, 24% of Afrezza was one in four patients versus 13% usual care met timing range greater than 70% with no increased hypoglycemia. Over 50% of the subjects who got to the end of the trial said they'd like to continue on taking Afrezza and the reason that such an important number is 50% of the people in this trial were coming off the best technologies of AID systems Omnipod and were generally satisfied with their treatment and to see that even when people switch they maintain control, they'd like to continue to have the freedom that Afrezza brings to them. We've met our 17 week primary endpoint, and our full 30 week data is expected to read out later this year, and we'll likely give that information to shareholders here in Q4. When you look at the meal challenges here on the right, the RAA [ph] is the red line clearly shows the post perennial glucose excursions relative to the initial dose of both groups you can see a distinct difference in the first two hours. And at the end of the study, when people were titrate to Afrezza, we did a second meal challenge, you can see greater improvement meal time control as people learned how to use the product. And what this gives us is hope that, when properly dose of Afrezza can really impact post perennial control significantly over the current standard of care. This data was just published in diabetes care last couple of weeks ago, as we look out, we see INHALE-3 is pivotal to transforming the adult population, but also laying the groundwork for pediatrics, where insulin pumps is the predominant competitor of choice when it comes to choosing inhaled injected or an alternative delivery mechanism. And we believe the switch study in INHALE-3 showing consistent results of efficacy and the overall population as well as sub populations, will be important as the INHALE-1 trial was only in MDI patients, and that was by design to really show and control the one difference in the trial. The INHALE-1 day will read out shortly, and we'll intend to file that next year for approval, hopefully in the future years for launch. When we look at Afrezza since I've gotten here, we've continued to grow year over year in a really good way. As we look out over the next 10-15 plus years, we see nothing slowing down Afrezza growing year over year. Finally, we will have proper data readouts, proper label updates, and now we have a capital and talent to continue to scale this business. We will wait for the data readouts. We are conducting some independent market research so we can update you in the coming quarters on what our plans are and what to do with the data readouts, as well as the additional indication what that will mean for shareholders. But we have grown consistently. We will continue to grow this brand for years to come. I now would like to turn it over to Chris.
Chris Prentiss: Thanks, Mike and good morning everyone. I am pleased to review select second quarter 2024 financial results. Please refer to our press release issued earlier today for a summary of our financial results for the second quarter 2024 as well as our 10Q, which was filed with the SEC this morning. The second quarter with total revenues of $72 million marked our 9th consecutive period of quarter-on-quarter, revenue growth and a 49% increase compared to the second quarter of 2023. For the six months period, we recorded total revenues of $139 million, a 55% increase over the prior year period. Let's now discuss the details. Tybeso DPI royalties contributed $26 million in second quarter revenue, an increase of 34% over the second quarter of 2023 and $48 million or 57% for the six months period. As we heard on UT's earnings call last week, they continue to experience strong patient demand, and are encouraged by the record referrals and new patient starts during the quarter for both PAH and PH-ILD patients. Collaboration and services, revenue was $26 million, an increase of 132% versus second quarter 2023, the six months period was $51 million or 125% compared to the same period of 2023, the increase over the prior year periods resulted from a substantially higher level of production activity, which was sold through to UT. Afrezza net revenue of $16 million grew 20% versus second quarter 2023 which was primarily driven by volume growth, a lower gross to net percentage of 37% versus 39% in the prior year, and a price increase. Similarly in the six month period, Afrezza net revenue grew 18% to $31 million, primarily driven by a reduction in gross to net percentage and price. The lower gross to net percentage was mainly the result of a change in estimate for Afrezza product returns. V-GO declined 7% to $4 million in the second quarter of 2024 and 11% to $9 million for the six month comparable period. The decline reflects lower demand as we have focused our attention on Afrezza. The next slide shows our revenue growth by source and basic EPS on a quarter-by-quarter basis over a rolling eight quarter period from the third quarter of 2022 through the second quarter of 2024. For the second quarter of 2024 total revenues of $72 million increased 9% sequentially versus the first quarter of 2024. After three quarters of positive earnings per share from Q3, 2023 through the first quarter of 2024 we had a net loss in the current quarter of $2 million, or $0.01 per share. This was the result of our early repayment of the Mann Group convertible note and mid-cap senior secured notes, which we completed in April and resulted in an accounting charge of $7 million recorded as a loss on extinguishment of debt. Now to our GAAP to non-GAAP reconciliation. We had a GAAP net loss for the quarter of $2 million, which, when adjusted for non-GAAP items, results in non-GAAP net income of $14 million. This compares to a non-GAAP loss of approximately 400,000 in the prior year quarter. For the six month period, we reported net income of $9 million and non-GAAP net income of $29 million. For the six month period in 2023 we reported a net loss of $15 million and a non-GAAP net loss of $6 million. The second quarter represents our fourth consecutive quarter of positive non-GAAP earnings, which we expect to continue as we execute on our current business plan. As we reflect on our progress on the first half of the year, total revenues grew by 55% for the six month period compared to the prior year, driven by growth in both our type, Tyvaso DPI related revenue and Afrezza growth. At $139 million this gives us an annual run rate of over $275 million in revenues. Net income for the first half of the year was $9 million, and non-GAAP income was $29 million. This demonstrates the significant progress we have made as our revenues are supporting our pipeline development efforts. Cash and investments were $262 million at the end of the quarter. This is after the repayment of both the Mann Group and mid-cap notes in April, leaving only the $230 million senior convertible notes due in March 2026. This cash position, combined with our delevered balance sheet, puts us in a strong position to continue to invest in our commercial products and our exciting pipeline. With that, I will turn it back over to Mike,
Michael Castagna: Thank you, Chris. As we look out over the next 12 months, here are some of the milestones we're going to talk about, I want to say thank you to the hard work the team has achieved in the first half, starting with our IND submissions here in Q1 which led to a kickoff of a bunch of work that we'll be looking forward to as investors and employees and patients and providers over the coming quarters and years. Tyvaso DPI continues to progress nicely as you think about what we've been doing in Danbury between making product today to supply the market demands, while preparing for hopefully positive readouts on TETON-1 and 2 and global expansion there with United Therapeutics. Our high-speed fill/finish line is now operational and certified on most of the strengths Tyvaso DPI. The spray drying capacity will be completed here in the third quarter. It's been installed, and now we're just running through the PPQ. What you'll see is, in the first half that will require some stability time and then filing with the FDA for approval. We expect that to be fully operational in the first half of '25 well in advance of TETON-1 and 2 reading out. As you look at INHALE-1 and INHALE-3 these are two pivotal trials we invested in over the last several years that are critical to the transformation we expect to bring to Afrezza over the coming quarters and years ahead. These data readouts will happen here in the second half, and they will set the stage for continued data publication and data releases for years to come, at the various diabetes conferences around the world. We are just getting started on what this can mean for ourselves as employees, as patients and as shareholders, and we're looking forward to continuing to give you more information as it comes in, in the coming quarters ahead. I think about the key value drivers that lay in front of us. Number one, the pipeline is not reflected in the value of our company. We continue to believe we're undervalued when we look at the value that's Tyvaso DPI royalties and manufacturing revenue relative to the other assets we have ongoing in the company. Just alone looking at 101, that we now look to be the only Phase 3 trial in the future, bringing this novel innovation to an unmet need population in NTM, where there's over 100,000 patients in the U.S. and roughly 15,000 that are refractory alone. And for every 1000 patients, this is $100 million in that revenue to MannKind. When I think about OFEV, the potential for this opportunity to help people living with IPF have a more tolerable option, let alone if we can see better efficacy, that would be amazing. This is a $4 billion market and growing, with lots of novel innovation coming, where we OFEV as a continued backbone of treatment, where hopefully our inhaled version will make a pivotal moment for patients living with IPF. And then we upgraded our Boston R&D footprint recently, as you may know, we have a site marble [ph] that lease will be ending in early '26 and we now have moved into a new facility here in Bedford, Massachusetts, where we have brand new R&D space, expanded our DPI technology platform, and we'll be consolidating our employees between the two sites over the coming 12 months. We're excited for that in terms of recruiting talent and continuing to have more capacity to do more research programs as we go forward. When it comes to Tyvaso DPI, this has been a great opportunity, not only for us, but for patients and United Therapeutics, it's transformed our company and has enabled us to execute our long term growth strategy of funding our pipeline and continue to be a self-sustaining company. As you can see here, for every 10,000 patients reimbursed, this is between $300 million and $350 million in total revenue to MannKind, between royalties and manufacturing revenue, we will anxiously await the TETON-1 and 2 we also will be starting to pay closer attention to the TETON-PPF study, as that comes forward, and we see these readouts, starting in the second half of 2025. When it comes to endocrine we've always known when you look at innovation in diabetes, especially type-1, it starts with kids. The parents will fight for the children. The doctors are more cutting edge, and we believe the payers will find an opportunity to cover Afrezza in a more reasonable way and give patients the opportunity to control their sugars. The pediatrics is where we look at when you think about drugs that have been on the market for a long time, and transforms, whether that's the insulin pumps that Outman built, Omnipod or CGM and Dexcom (NASDAQ:DXCM) that all type-1s use now standard of care. All these innovations started with kids, and we look at even GLPs today, these have been on the market nearly 20 years before we saw the inflection we've seen over the last several years in the weight loss category and why the adoption of GLPs? I know it's frustrating for all of us to think about we sit on with diabetes and endocrine but we are just now at the pivotal moment of new data coming out, along with hopefully the ability to transform our future. I'm going to stop there and we'll answer any questions, and just so everyone knows, we have several upcoming scientific and investor conferences where you'll get lots of new information for updated questions and oral presentations here in the coming months. Thank you
Operator: [Operator Instructions]. Our first question comes from the line of Olivia Brayer with Cantor Fitzgerald
Olivia Brayer: Hey, good morning, guys. Thank you for the questions. How are you thinking about IP and just revenue runway for your two pipeline candidates? And can you just remind us how well protected your Technosphere technology is? And then on the 201, update that we'll get in the fourth quarter can you give any more color on how many patients worth of data you expect to have and just how you're thinking about next steps once you do have those healthy volunteer data in hand?
Michael Castagna: Sorry, I heard the IP question. And then there's a second one. Then there's the data in hand with IPF is that what you said, I missed the second part.
Olivia Brayer: Yeah. Why don't we start with IP, Mike, and then I can follow up with 201.
Michael Castagna: Sure. So on the IP landscape with, I think it was Technosphere as probably your second question. So Technosphere goes out into the 2030 IP on Tyvaso with pending plus, what we have is probably another 2040-ish timeframe, 2043 and then the clofazimine will have QIDP and orphan designation as well as additional IP filed. So that looks to be 2039, 2040 and then same thing with IPF and the TETON that we look to have into the late 2030s so we feel pretty good about the overall IP of the company going into the next decade and a half or so. And that's assuming we don't do any innovation right. And so I think there is definitely things we're going to work on now to continue to innovate and make our products easier for patients to take. So we feel pretty good about the next, you know, 7, 8, 10, years as you as far as we can look out in terms of no major IP risk,
Olivia Brayer: Okay, understood. And then, yeah, just second question was around 201, and the data that we get in for Q, just any color on how many patients worth of data that you guys will have, and then obviously, just thoughts around next steps for that program going into 2025
Michael Castagna: Yes. So we have completed the first three dosing cohorts, which was single doses, dose escalation up to a max dose we're looking for, having to report no major findings so far. They're still going through the safety but nothing appears to be getting in our way to go into the multiple sending dose, which will be the next phase, and that'll happen over the next month, and then they'll take some time to analyze those results. So we expect that in Q4, what we'll be looking for is obviously cough tolerability, bronchospasm, anything around that lung administration, GI toxicity or tolerability. You know that we see any GI side effects in those patients, especially in the multiple sending dose. And then for those results, we plan to go to the FDA with a Phase 2/3 design, which we're still finalizing that's why I've not shared any details. And we'll hopefully see the FDA agree that type of a study design we've seen in some of the other competing programs here in IPF, but that's our intent, and hopefully that would get us to market right around when OFEV patent would expire. And so that's what we're kind of looking trying to work backwards from make sure we're on time, that we can be
Operator: Our next question comes from the line of Thomas Smith with Leerink Partners.
Thomas Smith: Just with respect to the ICoN-1 Phase 3 design, just wondering if you could comment on the powering assumptions for the six month primary endpoint and then for the interim analysis. It sounds like this is mostly a sample size re-estimation, but can you comment on whether there's any early stopping criteria built into this interim either for futility or superiority?
Michael Castagna: Sure, I missed your question on the assumption of six months. Sorry.
Thomas Smith: Yes. Just asking about the power and assumptions on the six month end point, what you've assumed in terms of placebo response and treatment effect?
Michael Castagna: Yes. So what I say is, when we in the design of ICoN-1, we benchmarked as best we could in refractory population for a delta of what we saw in our case for factory population. So if it comes out better than that, or placebo is not as good, you know that that all will benefit us. It is a dual primary endpoint in the U.S., meaning, or co-primary endpoint, I'll say, in terms of quality of life plus sputum. The rest of the world will be sputum only. So it'll be the same trial used with two different statistical plans. And the interim analysis is on 100 patients, it'll have a futility assessment, but not a superiority assessment in terms of shutdown from my knowledge, I know we have different numbers we need to treat if we feel like we're not powered appropriately, we can increase the powering of the study by increasing the patient numbers. So those are the key attributes we've tried to do, depending on which end point is looking, how they're looking in terms of quality of life versus sputum. So that's all predefined in the statistical plan. And I think, I think it's 90% power, but I need to double check that and confirm with you. Get back to you, but I'm not pretty sure it's 90% powered.
Thomas Smith: Got it, that makes sense. And then just one on Afrezza, I was wondering if you'd just comment on some of the feedback you've been hearing coming out of ADA with the INHALE-3 results, I guess, reception to the data set, and how you're thinking about translating these data and the INHALE-1 data to sales growth. You know, are these data sets you think could potentially impact 2025 prescribing, or is it more of a longer term dynamic?
Michael Castagna: Yes, I think so far the feedback has been very positive of those that attended ADA and listened to our data and watched our data. You know, the data is being prepared for publication. The first dose just got published in diabetes care. So I'd say overall receptivity has been very positive. The team had a small ad [ph] board at ADA just to get initial reactions. Again, continue to demonstrate increased confidence and we just got back at [indiscernible] research last week, which I couldn't get in time for the earnings call, unfortunately. But that also signals that amongst our highest riders, and that we our highest target values, that they are positively receiving the data as well. So far, all looks really good in terms of ability to impact future growth of Afrezza. Will that happen in a dramatic way this year? Probably a little bit in Q4 as things roll out in Q3 and the data gets published, but realistically it'll be 2025, and what I say about Afrezza is it's a direct reflection of our investment, meaning, you know, we've run the brand for profitability last year, and that's been able to while we wait for the data readouts and then make the decision to scale up and invest more. So if we want to grow it faster, it's going to probably take more investment. And just how much faster will that grow relative to the investment we make? And those are some of the work we're doing before we scale up any investment, so we can communicate appropriately to shareholders what we want to do. But I think right now, you know, the data is good enough to continue to drive increased growth quarters, and as we go out and then in pediatric obviously, is in Q4 and that will be the more important in terms of really inflection trends I'll call it meaning, you know, we can grow 20% versus 24% that's not going to get anybody excited, but if we think we can grow high double digits through peds launch [ph], that's going to be what's important at the end. And having that date in Q4 with a filing, hopefully early next year, that will set us up for early '25, early '26 time frame for peds [ph] inflection. So I think that's what you'll probably see, is my guess. But again, we're conducting additional research and insights to have some confidence before we make any big decisions here.
Operator: Our next question will come from the line of Gregory Renza with RBC (TSX:RY) Capital Markets.
Gregory Renza: Mike, maybe just keeping with 101, clofazimine inhalation, just curious as you and the team activate sites and stand up the trial if you had any feedback, and maybe touch on how sort of the activation and the entrenchment of sites is shaping your confidence in the program and the value proposition that you see with 101?
Michael Castagna: Yeah, I think it's true like Greg, you know, the team has been to about 10 sites. August will slow down a little bit for site activation just due to vacations and holidays, but they expect that to pick up a lot here in September. We already know they're pre-screening patients, a couple already scheduled for August. So I think it's only one month in. I wouldn't try to read too much positive or negative into it. I'd say so far the feedback has been generally positive, as we all suspect you know, how big is this refractory population? How quickly can we get to naive patients? How quickly can we move the dry powder along? These are things we're working on, as we know that's the much bigger population to go after. But I think in terms of enrollment trial in the U.S. and Asia Pacific area, there are enough patients to get that moving, enough patients to get hopefully ready for a good launch but the real opportunity is obviously the larger NTM population, but getting this trial moving is the first step into that foray. But you know, we continue to watch our case do well, that makes us feel very good about the bets here and the market affiliate has no options. I mean, so this is really exciting for patients. It's exciting for the treaters. It's exciting for the FDA, as well as our employees. We worked really hard to get here and from manufacturing standpoint, we'll be ready. And the trial I think is going a lot of interest from the top investigators. We feel pretty good about the sites that we're getting in the patient style we'll be recruiting very shortly.
Gregory Renza: Got it, I think at the top of the call Mike you mentioned, expanded access and maybe more to come. Just touch a little bit about that, maybe some of the timing and some of the inputs there. Thanks and congrats again on the quarter.
Michael Castagna: Thank you, Greg, yes, so I've asked the team to look to see if there is a way to get the EAP with the FDA sooner than later, and maybe that EAP would be for patients who don't qualify for the trial. And would the FDA allow us to provide access given there's only one treatment option out there. We don't have clarity on that yet. We've not approached the FDA yet, but that's really the key part of that comment, is if we could find a way to help more people sooner that don't qualify for the trial, we would be interested in that. Obviously, we don't want to have an EAP herd enrollment for the trial, that would delay our ability to help get that trial recruited. So that'll be some of the focus here is can we find a way to help those patients? That'll be in collaboration, but the FDA may want a certain amount of patients first, we'll have to see where they land.
Operator: Our next question will come from the line of Brandon Folkes with Rodman & Renshaw.
Brandon Folkes: Maybe just two for me, Mike, I know you said you can't talk too much about the potential Phase 2/3 trial in 201, but would you be able to just talk about maybe if you're considering multiple dose levels there, and just elaborate on what is first prize for you in this program? Is it something that's comparable on efficacy with better GI side effects? Or would you prioritize perhaps, sort of a potentially more efficacious drug here. And then secondly, just maybe on Tyvaso DPI can you just talk about the manufacturing capacity where you're at today, what needs to be done if TETON is successful? And just you know, sort of how much investment does that take? Thank you.
Michael Castagna: Sure. I'll take the second one first, because that's easy. So from a DPI manufacturing capacity, we've been able to build up substantial amount of inventory for United Therapeutics this year, we should be well on our way ahead of any TETON results in terms of scale and capacity, we don't see any limitations, as far as we can see with that approval, the investment in the plant has already been invested in by United Therapeutics all the equipment's been installed and purchased, so there's no additional investment that that's a major I'm sure it'll be small things here and there, but nothing that's significant for shareholders or for United Therapeutics at this point, that doesn't account for what UT may do independently MannKind, i.e. building their own plant that's a separate decision on their part. But as far as we're concerned, we'll be able to supply substantial amount of DPIs as we go forward. In terms of, what does a win look like? It's a great question, and we've had this internal debate ourselves in that, do we really want to demonstrate the safety side of this around the severe GI tolerability issues that happened? Is it important to try to go after increased efficacy, or is it a balance of both of those by getting to market as quick as we can? And I think that that triangle in terms of efficacy, speed and tolerability is something we're continuing to talk about and there's various ways you can design a Phase 2/3 trial to kind of build those attributes. And the question is, how fast can you get to market and help those patients? And what do you need to demonstrate, for example, if we were to demonstrate equal efficacy somehow, but you took existing patients on the TETON you may not see the GI benefit as much maybe you'll see people take less [indiscernible] or feel quite a lot better but you could also study in IE patients, where you'll see, hopefully, a large benefit in tolerability, which could be a huge benefit to outcomes and efficacy. Or you can go after higher dosing, which could generate potential better efficacy. But how much more we don't know, and that's all the questions we have for ourselves, as much as anything. And so because we are going into a Phase 2/3 design that does limit some of our forecast ability on efficacy, for example, but let's see the first readout here in this Phase 1, make sure patients can tolerate our target doses, and then we will you finalize that trial design. We're also meeting some thought leaders here in coming weeks and months to triangulate this exact question, but we have an idea of what we want to do, and we just want to bounce that off with some investigators before we come out and talk about it publicly. And then you were asking, do we want to go after dosing and multiple doses? And there's a strategy that could be two different doses and study them, or could be a titrate up dose effect, like you see in a [indiscernible] type design, where you try to titrate to the highest level dose. So those are the things we are looking at, and they all have pros and cons Brandon, so no magic answer here, but other than, we want to give this drug to patients as quickly as possible. And I think once we get on the market, then we can innovate even from there in terms of demonstrating additional trial outcomes, etc. So we'll get there, but let's get through the first step here. I think that's the most important, and then be with FDA.
Operator: That concludes today's question and answer session. I'd like to turn the call back to Michael Castagna for closing remarks.
Michael Castagna: I just want to say thank you to everyone. It's been a fantastic year, volatile year for all of us, but the Company's in a great spot. We're looking to close out the year strong and really get ready for '25 and '26 as we look at multiple data readouts on the clinical side across our entire platform and programs, as well as just upside into the inline revenue that we're driving with the diabetes business. So we feel very good about the future, hopefully awesome news on international expansion as we go forward Afrezza and continue to drive growth and help more patients, I just want to say thank you to all of our employees for all the hard work and all the shareholders for all your support. Have a great day.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.
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