Mannkind Corp Q3 FY2021 Earnings Call

Good afternoon and welcome to the MannKind Corporation Third Quarter 2021 Earnings Call. As a reminder, this call is being recorded on November 9, 2021 and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call until November 23, 2021. 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 the stated expectations. For further information on the Company's risk factors, please see their 10-Q 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 would now like to turn the conference over to Mr. Castagna. Please go ahead, sir.

Good afternoon, everyone. I apologize for that delay. We were having a problem with the audio and couldn't quite figure out whose end it was. So I do apologize, and we'll jump right in and I'll try not to speak faster than necessary. Let's talk about our operational highlights, where we've been, and where we're going. First, I want to thank our shareholders for their support and feedback over the last few months. Obviously, the news we received a few weeks ago was not something we expected, but we do think it's manageable, and we will get through it. I also want to thank our employees who worked hard during Q3 to ensure we are executing on our three key priorities: Tyvaso DPI production and scale, progress of our pipeline, and driving Afrezza growth in the U.S. As you look at our revenue, we're thrilled to see that in Q3 2021, we had $22 million in revenue, which was a 45% increase over last year. And when we looked at Afrezza, we grew 34% to $9.8 million over last year. Overall, year-to-date, we have achieved 35% total revenue growth and 25% growth on Afrezza. We're proud of those results and look forward to continuing to drive future growth as we move forward. Now, let’s discuss our units of collaboration. I'll talk about that in the next slide, but I want to let you know that we’ve begun commercial manufacturing and are continuing to hire and expand our facility in Danbury to handle the expected future demand coming from our partnerships. On the pipeline, I'm going to share some new data with you today as we had some really positive data come out in our pre-IND talk studies. We plan to start Phase 1 here in Q4. Additionally, we're wrapping up formulation work with our TGF data for IPF and are almost done with ASMI DPI dosing in terms of innovation. In the endocrinology area, Afrezza experienced 16% growth year-over-year in paid prescriptions. As you may recall, we ended our free goods programs in January of this year. We've launched our pediatric trial in Q3. Currently, we are enrolling patients at five sites that are up and running as of today. In Q3, as we ended the quarter, we weren't satisfied with the direction we were going, and we decided to refocus our resources in the U.S. as we headed into Q4 by removing any distractions related to that venue. We exited MSO in Australia and ceased co-promote liquidity effective in Q4. We believe that our resources are best focused on these top three priorities: driving U.S. Afrezza, managing the pipeline, and collaborating with UT. We will continue to look for potential global partners to assist with our ex-U.S. strategy moving forward. For our best short-term impact, we need to drive faster growth here in the U.S., ensuring success worldwide. Regarding liquidity, we are pleased today to close the sale leaseback for $102 million in proceeds, on top of the $181 million we had at the end of September. As you’ll see towards the end of my discussion today, we are well-positioned for future growth, and that capital will be used effectively. On Tyvaso DPI, we expect to receive approval, hopefully with United Therapeutics by the summer of 2022 or earlier. A complete response was received noting a single deficiency related to a third-party facility's analytical testing for possible drug substance. This deficiency had absolutely nothing to do with our Tyvaso DPI products. The good news is we think it’s manageable, and we could see that we have the same indications with Tyvaso Inhalation Solution for PH-ILD, and we did not have any contraindications or box warnings in the labeling that we've noted. The citizens petition is not completed, but it hasn't cited us as deficient in DTRF. We are focused on resolving this issue and getting approvals for Tyvaso as soon as possible, no later than summer '22 or earlier. At MannKind, we are focused on manufacturing prelaunch products and scaling up our factories for future indications. Looking at Afrezza in the U.S., we had a strong Q2. We've faced some headwinds early in Q3 as COVID-19 has shut down offices again. We added distractions in trying to secure liquidity, which did not go in the direction everyone desired. This caused us to refocus our energy in Q4 as we prepared to end the quarter. Our primary focuses now are: number one, achieving our pediatric studies scaling for enrollment with more patients onboard; number two, we've hired a primary care pilot in the Southeast that will be about 30 FTEs between the sales force and commercial team, set to launch in January; and number three, launching a consignment model with top pharmacy chains. This means that instead of having a middleman involved in our inventory chain, we will now have inventory stocked with third-party chains, which will improve patient access and ultimately decrease costs along the value chain. Fourth, we'll be launching a pilot to enhance patient retention during the first 12 weeks of treatment, expected to kick off in December. We have also launched a program called the new Afrezza challenges CGM called ‘Seeing is Believing,’ which focuses on approximately 160 doctors who have never witnessed Afrezza. We noticed that within the first 10 days, 30% of these doctors wrote their first prescription for Afrezza. Additionally, we continue to see improvement in reimbursement rates, with new prescriptions up 45% in the latest four weeks versus the Q3 average. We are seeing early signs of trending momentum as we exited Q3. One thing I want to share with you is a new dataset presented just last week in an oral presentation by Kevin Kaiserman. We are concentrating on driving data to control the company and to discuss with the FDA how to best update our label to better reflect the dosing upfront with Afrezza. We were recently informed by the FDA that we have been accepted into their MIDD Pilot program, which is the Model Informed Drug Development Program, and we hope that this will help us understand how we can change the label to better reflect dosing that will enhance glycemic control. As you can see in this trial, the dosing we're using in kids essentially rounds down to the nearest dosing cartridge. This streamlined dosage aims to simplify the effective dose conversion for new patients starting on Afrezza. What you can observe in this chart shows that when we use our new formula of double the injected dose, rounding down to the nearest dose of Afrezza, we are achieving significant results. Returning to my discussion, I will now turn it over to Steve, and he will close with thoughts on our pipeline.

Thanks, Mike. And good afternoon. I'm very pleased to review selected third quarter and year-to-date 2021 financial results. Please supplement this call by reading the condensed consolidated financial statements and MD&A contained in our 10-Q, which was filed with the SEC this afternoon. Let's start by looking at revenues for the third quarter of 2021. Afrezza net revenue was $9.8 million versus $7.3 million in 2020, representing a growth rate of 34%. The components of this growth include a demand increase, consisting of symphony-reported paid TRx growth of 16%, and price adjustments, including a more favorable gross-to-net percentage of 40% versus 41% in 2020. The TRx for the third quarter of 2021 and 2020 were both adversely impacted by the COVID pandemic. Year-to-date growth of 25% was driven by symphony-reported paid TRx growth of 11%, along with a more favorable mix of Afrezza cartridges and pricing, which included a 2% improvement in the gross-to-net percentage. Moving on to collaboration services, revenue for the second quarter was $12.5 million versus $8.1 million for 2020, representing a 54% increase. This increase was primarily due to additional contracted activities associated with our United Therapeutics collaboration and a decrease in the recognition period used for R&D services and licensed performance obligations. The year-to-date revenue from collaborations and services was 44%, totaling $35.1 million, mainly from our collaboration with United Therapeutics amounting to $33.5 million. The graph on our next slide shows the quarterly and September year-to-date Afrezza gross margin on a GAAP basis. This margin has been increasing each quarter during 2021 and stands at 55% year-to-date on a GAAP basis and 62% on a Non-GAAP basis, which excludes the $2 million expense recorded in the second quarter for the insulin supply agreement amendment fee. We continue to have excess manufacturing capacity for Afrezza, which impacts the cost of goods recognized in our gross margin, which can fluctuate significantly quarter-to-quarter, depending on the timing of bulk manufacturing and finished products. I believe that reviewing the year-to-date numbers provides a better perspective on tracking where our margin is for current Afrezza performance. Looking to the future, we expect favorable impacts to our gross margin as we start to manufacture commercial scale Tyvaso DPI, which should improve our overhead costs and drive plant efficiency. This slide updates the information presented during the second quarter earnings call and outlines the different performance obligations with United Therapeutics and how we're recognizing revenue associated with each as of September 2021. Starting with the services, we've been recognizing revenue on a ratable basis over the expected clinical development time for Tyvaso DPI, which started in 2018 through the PDUFA date in October 2021 when our performance obligation was substantially completed. We recognized $9.9 million in the third quarter and $28.4 million year-to-date. There is approximately $1.5 million of deferred revenue associated with this performance obligation on our balance sheet at September 30th, which we anticipate recognizing in the fourth quarter. The technology license pertains to royalty revenue, which we expect to recognize on net sales of Tyvaso DPI once approved by the FDA and sold by United Therapeutics. As previously disclosed, the royalty rate is in the low double digits, and we plan to be more specific once Tyvaso DPI is approved. The next performance obligation is manufacturing services associated with the commercial supply agreement signed in August and amended in October, extending the agreement for 5 to 10 years. Revenue will be recognized as we sell commercial products to United Therapeutics. As of September 30th, we have begun manufacturing commercial products but have not yet commenced sales to UT. We expect to begin selling products to UT in the fourth quarter. Our next performance obligation covers pre-commercialization services recognized between the second and third quarter of 2021, totaling $0.8 million year-to-date. This revenue does not carry a profit margin and reflects costs incurred by MannKind while delivering the services. Finally, the performance obligation for Tyvaso DPI next-generation R&D is recognized using the percentage of completion method during the second quarter of 2021 and the first quarter of 2022. This revenue also does not have a profit margin and represents costs incurred by MannKind when delivering the agreed-upon activities. We recognized $2.4 million and $4.3 million in the third quarter and September year-to-date periods, respectively. The timing associated with our United Therapeutics collaboration can certainly be confusing, and I hope I was able to clarify some areas for you. If you strip away the technical accounting, our collaboration with UT has yielded over $100 million in upfront and milestone revenues, recognized over a 3-year period. We have agreed to perform additional work for Tyvaso DPI, for which we are compensated by UT. Our commercial manufacturing efforts have started, and we plan to begin selling products to UT in the fourth quarter. Let me conclude with some final comments regarding our financial resources and liquidity. Today, we are a financially stronger company than we have been over the past 5+ years. We ended the third quarter with approximately $180 million in cash and investments and added roughly $100 million to this balance with the closing of the non-dilutive sale leaseback of our Danbury manufacturing facility yesterday. We are now in a solid position to fund our growing pipeline, make targeted investments behind Afrezza, and seek business development deals that complement our business and provide higher rates of return for our shareholders. With this, I'll turn it back over to Mike for some additional comments.

Thank you, Steve. And thank you, everyone else. With the sales impact now closed, you can see the proceeds are focused on how we can take opportunistic actions on Afrezza, which we've not been able to explore in the past. Additionally, our pipeline today is robust and growing rapidly. It's expanding so fast that we physically cannot manage more without hiring significantly more personnel. Next year, the reason we're discussing the pipeline is that we won't likely hold another shareholder call until March or February once Q4 closes. There are a lot of positive developments in the pipeline to share with you between now and then. On this slide in particular, you can see that the cannabidiol is in Phase 1, exploring acute panic disorder as well as anxiety. We're excited to share this information with you for the first time. We know Clofazamine works, and we are pleased with its performance since our acquisition of Qrum in mid-December. This recent top-line data shows that the effect lasts for 56 days post-treatment, which is remarkable. As we analyze the data, we've been observing high, medium, and low doses relative to minimum inhibitory concentration, which is shown in the charts. Following a 28-day regimen, we are monitoring how fast the drug clears and how much vesting effect it has in the long-term versus the plasma. Additionally, we can confirm that the drug remains in the lungs for a considerably long time, allowing for effective treatment of lung diseases. The plasma levels decrease much faster, which is ideal, and we maintained at least eight times the MIC with no dose-limiting side effects. This gives us confidence as we design innovative trials and plan for the next stages of development. Looking ahead, by year-end, we expect to have the Phase 1 readout in Q1. Regarding our next preclinical development focus with TGF beta for IPF, we recently completed the dry powder inhalation formulation and are prepared to assess the pharmacokinetics involved. This will inform us of lung and plasma levels as well as the drug's half-life. As we progress, our technology continues to demonstrate rapid lung levels with minimal systemic circulation, aligning perfectly with our target profiles. Our agreement with Thirona allows MannKind to seek a full license to treat fibrotic pulmonary diseases. They are currently developing the drug for a dermatological application in keloid scarring. Looking out over the next five quarters, particularly just discussing 2022 for now, we anticipate numerous key milestones. In Q1, we will initiate the Thirona program. We expect the Phase 1 results for MNKD 101 (Clofazamine) by then and similarly, for Cannabinoid Technosphere. We are targeting MNKD 201 for toxicological studies around Q2. All this data will prompt meetings with the FDA to align strategies that could lead us to initiate Phase 2 on 101 by year-end and Phase 1 on MNKD 201 also by year-end. This is our best estimate as of today regarding what is lined up. There's significant work ahead, but when you ask why we are seeking additional funds, it's because we foresee our pipeline advancing dramatically over the next 12 to 24 months. We have the capability to grow more now than we have in the previous five years. This data excludes any new opportunities that may arise from external collaborations. We have begun work on several formulations that could evolve into additional collaborations in 2022. There's considerable excitement about what lies ahead in our pipeline. As we reflect on 2021 milestones to round out the year, I cannot believe it's already November. It’s astonishing how fast this year has gone. Overall, we had a very successful year, and while we aimed for an approval of Tyvaso DPI, we received a CRL, which is unfortunate. Nevertheless, our team did an admirable job with the manufacturing process for scaling. The United Therapeutics team also excelled in collecting clinical data in record time. The challenges we faced are typical for inhalation products during their first round. In this case, we had a clean approval pathway that ultimately hung on a technicality from Q2. Overall, we are pleased with MannKind's progress, and it is stronger now than it has been in the past five years. Our future is brighter than ever. We observe double-digit growth extending out into the future. Thank you to everyone, and I will now welcome your questions.

At this time, I would like to remind everyone of the instructions for asking questions. Our first question comes from the line of Gregory Ranexa from RBC Capital Markets. Please ask your question.

Hi, this is for Greg. Thank you for taking our questions, and congratulations on the progress.

Thank you for taking our questions, and congrats on the progress.

Can you hear me? Operator, can you hear me?

Yes, I can hear you.

I apologize to our analysts and our shareholders as we are experiencing technical difficulties from the start of this meeting. We'll give it one more minute. You can hear your questions, but we cannot.

Excuse me, presenters, could you hear me?

Okay. To our analysts on hold, I apologize, we cannot hear you, but we will take your calls and get you prepared for updates after this earnings call today. Again, I apologize for the technical difficulties that caused us to start late. This has been a challenge for us. I must have jinxed ourselves by mentioning how smoothly these calls typically go. But thank you to everyone for your patience. I know we have a retail shareholder meeting tomorrow, and we look forward to that. Obviously, any retail shareholder listening today, please email Rose or IR if you wish to join that meeting. If you have any questions, please submit those in advance so we can address them in an organized manner. Hopefully, we won’t encounter further issues.

Hold on. Okay. Thank you for your time.

Thank you again for participating. This concludes today's conference call. You may now disconnect.