Mannkind Corp Q4 FY2020 Earnings Call

Good morning and welcome to MannKind Corporation Fourth Quarter and Full Year 2020 Earnings Call. As a reminder, this call is being recorded on February 25, 2021, and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call until March 11, 2021. This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainty, which could cause actual results to differ materially from these stated expectations. For further information on the Company’s risk factors, please see their 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 would now like to turn the conference over to Mr. Castagna. Please go ahead, sir.

Good morning and thank you everyone for joining us today. We've never been busier and more excited about our future transformation. Let me start by acknowledging our Founder, Al Mann, who passed five years ago today. It's also today that I was excited to join MannKind and take our journey forward. We would not be here today without his generosity, as well as the trustee who supported us through the transformation over the last five years. I want to thank everyone again and look forward to sharing our strategic direction relating to 2021 and beyond. I want to go back to what we laid out in January of 2020, which is our strategy around the focus of endocrine disease and orphan lung. Today you'll start to see how that begins to shape out and what we did in 2020 to set us up for that direction in the future. Additionally, you can see with our acquisition of QrumPharma that we will not be limited by our current proprietary technology, but we will look for the best opportunity to bring shareholder value. Therefore, we believe that integrating examples of our technology, such as stake and nebulized products, will be a great asset for patients in the future, and we will focus, execute, and deliver to generate shareholder returns as we go forward. The last thing I'd also add as we begin 2021 is that you will quickly see our technology becoming a platform for us to support other pharmaceutical companies—a capability that we will be looking forward to exploiting. I'll discuss this at the end of our presentation this morning. Now let's reflect on 2020, where we had to deal with the unprecedented challenge of COVID. MannKind made tremendous sacrifices to ensure we came out stronger than when we entered. We took extreme measures in terms of pay reduction and cost cutting. We developed the ability to work from home and revamped our commercialization model. All this proved that we could make it through one of the worst pandemics in the country's history and emerge stronger, having a great Q4 here as we exited 2020. Additionally, when you look at our open lung strategy, United Therapeutics and MannKind delivered on all the key Tyvaso stability studies and clinical studies despite many COVID trials being shut down. United also purchased a prior new vessel for $105 million, which means we have to accelerate everything on our end by four months to get ready for launch at the end of 2021. Furthermore, we were able to secure an opportunity to acquire QrumPharma or clofazimine in December. On the endocrine disease side, Afrezza had record quarterly net revenue of $10.1 million, which is a 30% increase versus Q4 '19, and a sequential order growth of more importantly, 38%. During the timeframe when we had our full sales force limited due to COVID shutdowns, we were able to grow net revenue by 28% versus 2019. This growth is primarily due to the adjustments we made in our commercial model to ensure a stronger patient experience and to retain a larger portion of our patient base, which has started to yield results. We were also able to engage with the FDA regarding our clinical protocol for our Phase 3 pediatric study. I look forward to providing more insights on that soon. Finally, we ended the year and entered into a co-promotion with Thyquidity, which we're excited to launch this week through our sales force. Now we have a full staff with all key leadership functions, including Chief Scientific Officer and Regulatory Medical, as well as reimbursement and access. We're very excited about the talent that is joining the company and the direction we're going across all functions. On the Tyvaso DPI timeline, we've completed all key opportunities in Q4. The top line PK study results are coming soon, and the submission should be ready by the end of Q1. We hope that UT will get an IoT indication for their Tyvaso and nebulized product in April, and we anticipate filing the NDA in early Q2 2021. We expect the FDA to accept the NDA submission in the same quarter, and in Q3 we will begin developing manufacturing preclinical batches while scaling up our manufacturing facility to meet future indications and demand. In Q4, we expect to receive FDA approval. Regarding topline results—if our shareholders haven't seen them yet—our primary objective of safety and tolerability was successfully achieved through our switch study from Tyvaso to Tyvaso DPI. Notably, 96% of participants completed this treatment phase, with no serious adverse events reported. Additionally, the secondary objectives around efficacy and quality of life measurements showed improvement over the nebulized formulation, indicating that our technology results in deeper lung penetration and consistent dosing impacts. The optional extension phase with ongoing patients has provided us insight into anticipated outcomes in real-world dosing. We expect to confirm the comparability of our new manufacturing process against clinical trials in upcoming updates with UT. Patient variability for Tyvaso DPI continues to show less variability compared to the nebulized formulation, and no significant findings have been noted in the safety profile. Analysts are beginning to factor in the data from our study into future models, and we recently saw two upgrades in price targets from Oppenheimer and BTIG. Thank you for that support. One of the analysts upgraded their forecast for United Therapeutics' Tyvaso revenue. We anticipate that the majority of future sales will stem from the Tyvaso DPI formulation, as it enhances patient experience and retention, while also enabling us to explore potential new indications and patient populations. The acquisition of QrumPharma and inhaled clofazimine was a milestone for our company. We acquired Qrum in December 2020 for $12.75 million in cash and stock, and you can see how these figures are reflected in our Q4 financials. The inhaled clofazimine is currently in development and we are looking at Nontuberculous Mycobacterial (NTM) infections as our initial indication, an area with significant unmet medical need and no effective treatments. The team has worked to obtain FDA orphan designation and QIDP designations, hopefully allowing for fast tracking in the future. Phase 1 trials are expected to begin in late 2021, and we have received promising preliminary data supported by NIH funding. I'm excited about Thomas Hofmann, the founder of Qrum, joining us as Chief Scientific Officer. Dr. Hofmann is a pediatric pulmonologist with extensive experience in inhaled drug discovery and development and has been instrumental, especially in navigating discussions with the FDA regarding our inhaled therapeutic products. Why are we enthusiastic about Qrum? It's crucial to understand our motivations. First, we see high potency in the minimum inhibitory concentrations against NTM, as well as effective lung penetration through their nebulized formulation compared to oral delivery. The long half-life of the product offers a potential for less frequent dosing. We've observed positive animal efficacy data in mouse models, and GLP studies are currently on schedule. Let me walk you through some early data from the Qrum team. We've decided to refer to this product as MNKB101 going forward. In animal studies, MNKB101 demonstrated superior efficacy compared to oral clofazimine after 28 days of dosing. Whilst oral clofazimine showed minimal reduction in infections, MNKB101 showed a 99.99% reduction compared to saline control. This significant improvement in delivery via nebulization holds promise if we can successfully develop it into a DPI formulation. Market feedback suggests a preference for nebulized formulations, but we believe the DPI will enhance patient experience, especially going forward. Now, let me discuss Afrezza after our look at orphan lung opportunities. We are committed to further establishing Afrezza and expanding its sales throughout 2021. The last few years have seen a significant volume of publications detailing its efficacy, safety, and dosing. Afrezza's dosing parameters were a key area of misunderstanding, but those have been clarified, and we can effectively communicate safety and efficacy results. Our base of approximately 3,000 prescribers offers substantial growth potential year after year. The commercial medical teams are now stable and our expanding talent pool is an added asset. The safety profile is well-established based on over 5 years of patient data, and we plan to expand with pediatric indications as well as evaluate a collaborative study for gestational diabetes in 2021. In our recent discussions with the FDA and their feedback, we are pleased with the positive interaction surrounding Afrezza's dosing and conversion, highlighting the importance of our first dose in the office without concerns on tolerance for higher initial doses. In our study design, we are incorporating a consideration for usual care alongside switchover randomization to ensure a solid foundation for the trial. At the 26-week mark, everyone enrolled will transition to Afrezza, and we will collect safety data for an additional 52 weeks on roughly 260 patients with a follow-up during a 4-week period. We are optimistic about this design and the agreement from the FDA regarding it. As we focus on data collection, we'll aim to create awareness of Afrezza. Our collaborations this year are paving the way—for example, we are sponsoring significant diabetes events to educate. Additionally, we’re in discussions with CMS regarding better positioning in the Medicare population and leveraging the clinical data we've generated for payers. Digital diabetes management, including integration with CGM, is critical. Our new reimbursement initiative, Afrezza Assist, piloted in Q4 and formally launched in Q1, is designed to shift prescriptions from specialty pharmacies to lower-cost centralized pharmacies. We anticipate increased patient transitions into paying customers due to these efforts, alongside advocacy for inhaled insulin among patient groups and payers. Regarding Thyquidity, our focus here is solely in the pediatric segment, which presents a significant opportunity ahead of Afrezza's launch. As for financial impacts, we receive quarterly payments for our promotional activities and royalties on gross profit from this launch. I will now turn the call over to Steve to review our 2020 financials.

Thank you, Mike, and good morning. I am pleased to review our fourth quarter and full year 2020 financial results, which show record quarterly Afrezza net revenue, continuous Afrezza gross margin expansion, and our ongoing commitment to efficiently managing our cash reserves. We will also provide details regarding the non-binding Letter of Intent we have entered into for a sale leaseback of our Danbury manufacturing facility. I will start with select financial highlights, which I will supplement by reading the consolidated financial statements and MD&A contained in our 10-K filed with the SEC this morning. Let's start by examining the revenues for the fourth quarter and full year 2020. For the fourth quarter, Afrezza net revenue was $10.1 million, compared to $7.8 million in 2019—a growth rate of 30%. The increase was driven by volume growth stemming from underlying Afrezza prescription demand, which rose 5% year-over-year, coupled with a more favorable gross to net percentage of 38% versus 44% in 2019. Furthermore, we saw a favorable mix of higher insulin unique cartridges and a $1.1 million accrual reversal related to the termination of our previous year's free goods program as of December 31, 2020. The termination of the program is expected to negatively impact TRx by approximately 15% in 2021 versus 2020. It's important to note that these were free prescriptions and did not generate revenue in 2020, so our net revenue will be positively influenced as a portion of those patients transition to paying for their insurance coverage, aided by our Afrezza Assist patient hub or purchasing through our cash program. Additionally, an increase in wholesale inventories observed in the fourth quarter of 2020 contributed approximately $0.5 million of Afrezza net revenue. The COVID-19 pandemic continued to impact our sales and marketing efforts in the fourth quarter, with physician access, both face-to-face and digital, experiencing constraints across different geographies. Turning to full-year 2020 comparisons for Afrezza, net revenue grew by 28% versus 2019, driven by volume, a favorable cartridge mix, pricing, decreased gross to net percentage, and the reversal of our free goods program. Moving on to revenue from collaborations and services, for the fourth quarter, this revenue was $8.4 million compared to $8.2 million for 2019, while full-year 2020 revenue was $32.8 million versus $37.7 million for 2019. The expected reduction in 2020 revenue was primarily due to the recognition of the $10 million United Therapeutics research agreement, which was recognized over the period from the fourth quarter of 2018 through the second quarter of 2019, as our performance obligations were substantially completed. Our gross to net deductions were 38% of Afrezza's gross revenue in the fourth quarter of 2020. Normalizing for the exclusion of the free goods program termination accrual reversal, the non-GAAP gross to net percentage is 41%, consistent with the third quarter and favorable when compared to the earlier quarters. The improvement in gross to net percentage primarily stemmed from our strategy to shift business through specialty pharmacies instead of traditional wholesale avenues, in addition to a decrease in the Medicare rebate accrual and a downward trend in our core payment assistance program, as patients faced lower deductibles during the second half of the year. Our gross margins have been improving as well. A table showing gross margin from Q1 2019 to Q4 2020 reveals that our gross margin peaked at 64%. If we adjust for the $1.1 million accrual reversal tied to the termination of the free goods program in Q4 2020, the non-GAAP gross margin for that quarter would have been 59%, indicating significant growth from the third quarter's gross margin of 51%. Focusing now on operating cash efficiency, we will compare the full year's data from 2020 versus 2019 and 2018. The top of each vertical bar represents Afrezza net revenue, which nearly doubled over two years to $32.3 million whilst the bottom indicates non-GAAP net cash used in operating activities, which decreased by almost half over the same period. The increase in net revenue contributed to reduced cash burn primarily due to our effective management of operating spend, evidenced by a full-year total of $53.1 million. The average quarterly non-GAAP net cash used in operating activities remained steady, averaging $13.3 million. At the end of 2020, we held $57 million in unrestricted cash— bolstered in the fourth quarter by a $12.5 million milestone payment from United Therapeutics and an additional $10 million related to the funding of the FDA loan credit facility. Previously discussed was our consideration of a sale leaseback of our manufacturing and R&D facility. We have now entered a non-binding letter of intent to sell building one, which serves as our manufacturing facility. It is worth mentioning that we are not selling the manufacturing segment itself, but merely the improved structure and layout. Currently, we are in the due diligence phase, expected to complete by the end of Q1, leading to the signing of a definitive agreement that projects sales prices between $95 and $105 million, with a 20-year lease term that includes five-year extension options, resulting in an annual rent between $10 and $11 million. Proceeds from this transaction will be used for general corporate purposes, including partly paying down senior secured debt. There are no assurances that we will finalize a definitive agreement on the terms described, and completion will rely upon satisfactory due diligence by the buyer. To summarize our financial results: firstly, we achieved record quarterly Afrezza net revenue despite experiencing headwinds from the COVID-19 pandemic. Secondly, we continue to see improvements in gross margin and gross to net ratios. We remain diligent in managing our cash flow while support our commercial efforts to proceed further with developing Tyvaso DPI for United Therapeutics, alongside advancing our pipeline, which Mike will outline shortly. We are also progressing towards a non-dilutive financing strategy totaling approximately $100 million through secured assets. Thank you, and I will hand it back over to Mike for more comments.

Thank you, Steve. For those of you who don't know, we've invested over $250 million in our Danbury facility to build the infrastructure required for scaling further and for the DPI process. The timing is right to maximize the value of this asset as the current market conditions are ideal for these types of transactions, especially with the challenges COVID has introduced regarding office and traditional retail real estate. This long-term commitment on our part, alongside our investors, requires a forward-thinking mindset, as we believe this technology will have multiple revenue expansion opportunities over the coming years. This does not alter our day-to-day operations; we will continue investing in facilities to expand production for Tyvaso DPI. The capital we gain will allow us to steer the company towards cash flow breakeven. I'd like to discuss our pipeline and collaborations next. In the endocrine category, we are preparing for the approval of Afrezza in new U.S. and Brazilian markets while progressing there. Secondly, we will be expanding Thyquidity, which allows us more opportunities with our current sales force infrastructure. The third point is about indication expansion. We are currently focused on the pediatric setting, and the feedback from various sites and CROs is exciting, with hopes to launch this product by the pediatric market in the near future. We have conducted early reviews of pilot studies that show promise. Our efforts in India with Cipla are also underway; they are conducting a Phase 3 trial that is anticipated to wrap up quickly given the population size. We're executing our new dosing protocol that is being piloted in Type 2 patients with encouragement regarding that data. We hope to eventually share our findings publicly, which could highlight the benefits of Afrezza. Additionally, we expect our partners in Australia and Brazil to file Afrezza applications this year in the first half. In the orphan lung category, we see five opportunities moving forward. First is Tyvaso DPI with United Therapeutics, encompassing both PH and PHILD indications that we are currently exploring. Secondly, our development of KV101, known otherwise as CorPath plus the Qrum for NTM, is scheduled for Phase 1 trials in Q4. The remaining three programs are now prioritized focusing on MannKind 201 for idiopathic pulmonary fibrosis, MannKind 301 for cystic fibrosis, and MNKD 701, which we will not disclose for competitive reasons. We now have five short-term goals related to orphan lung diseases, notably building substantial programs around them. Another element that has not been discussed for a while is the Cannabidiol partnership with Receptor Life Sciences. Under this agreement, we will receive milestones and royalty payments as the product moves forward within FDA regulatory pathways. Our focus is now on panic attacks, which will be taken through a proof-of-concept study. We also have ongoing eligibility for royalty payments on a small molecule enzyme inhibitor targeting solid tumors that have been fast-tracked by the FDA. We see a number of short-term revenue expansion opportunities ahead over the coming years driven by our current marketed products, the orphan lung pipeline, and other programs we are partnering out over time. While early indicators in 2021 point to a promising trajectory, we cannot disclose specifics regarding our partnerships or formulations at this time. However, we are actively pursuing approximately 10 formulations this year, with others underway as various therapeutic opportunities arise. In 2021, we have ambitions for licensing four assets that previously featured in our pipeline, all of which are set for partnering in the upcoming months. We also wish to emphasize the potential of our Dreamboat family alongside our single-use Cricket family. The Cricket technology should yield significant opportunities for our pipeline and formulational developments as we progress. In 2021, our agenda remains busy, as only February signals significant efforts ahead, and we will continue rapidly moving across many initiatives focusing on both pipeline and corporative priorities. ADA in June to showcase Afrezza is exciting, with research being released regarding pediatric impacts, which will round out our data presentation. I'd like to remind everyone about our $25 million debt that becomes available upon Tyvaso DPI approval. It has been a long journey to achieve where we are now, and we take great pride in the progress of the team across the company. I want to express my gratitude to our employees especially for all they've accomplished. In 2020, despite adversities, we emerged even stronger thanks to their commitment. I hope that as we move through 2021, the challenges of COVID will diminish, allowing us to return to a more normal operational environment. Thank you again for your time, and we look forward to your questions.

And we'll take our first question from Brandon Folkes with Cantor Fitzgerald.

Thanks for taking my question and congratulations on the progress. I have a few questions. Firstly, regarding Afrezza's gross to net, how should we forecast this for 2021 and beyond? Secondly, in regard to the Danbury facility, can you provide some color on how much you expect to reinvest in the business going forward? Lastly, on potential business development, can you clarify your licensing pipeline?

Let me make sure I captured your questions correctly. The first is around gross to net, which Steve will address, the second is about the use of proceeds, and the third involves our pipeline and business development strategy, right?

For gross to net, we anticipate maintaining a percentage between 40% and 42% in 2021, continuing our strategies to navigate fluctuations in the market. With the Danbury facility, we aim for prudent cash management. While more available cash leads to opportunities, we want to secure our position before considering any reinvestment aimed at accelerating business growth.

Regarding our business development area, while we're evaluating options, we want to ensure a solid approach where we capitalize on Phase 2 and Phase 3 opportunities. Our current focus on orphan lung conditions remains strong. We're considering funding Phase 1 projects and determining whether to partner or retain those, so no concrete plans yet but we must stay opportunistic.

Next, we'll go to Oren Livnat with HC Wainwright.

With a lot happening recently, I'd like clarification on Afrezza, especially concerning gross to net realized value per script, given the transition to specialty pharmacies. Should we anticipate further increases in Q1 and beyond?

Our concern has shifted from Q4 to Q1, as the environment changes, with a strong focus on refill prescriptions rather than new patients under our operations. Once existing patients exhaust supplies, we expect them to return to the market. We rectified previous barriers restricting PAs, ensuring patients are assumed to have insurance coverage, so we project about 98% of prescriptions will yield revenue in 2021.

Regarding Tyvaso DPI, I know you're limited with what you can share, but can you remind us why you're confident about getting approval for both the PH and PH ILD indications? Is the path largely bioequivalence?

We approached this through pre-NDA filings, and the FDA's response has indicated they agree with including both indications for Tyvaso; thus, we expect the extrapolation for Tyvaso DPI. We also included ILD patients in our human factor studies, demonstrating that they can effectively use the device and inhale appropriately. This supports our confidence with these previous studies.

Next, we'll go to Thomas Smith with SVB Leerink.

Hi, good morning. This is John, filling in for Tom. I have a couple of quick questions. First, can you provide insight into the tolerability differences between Tyvaso and Tyvaso DPI? Also, what is the anticipated size of the pediatric study, and how will titration be addressed?

To address the tolerability question first, most patients transitioning from Tyvaso to Tyvaso DPI have responded positively, with 49 out of 51 completing treatment. This indicates most patients are comfortable with the dry powder formulation, and we haven't seen concerns arising from previous nebulized formulations. For the pediatric study, our plan is approximately to evaluate 260 patients, accounting for a 20% dropout rate, expected to complete around 210-220 in the end. We’re also finalizing protocol discussions with the FDA and are focused on robust titration strategies.

Next, we'll go to Steven Lichtman with Oppenheimer.

Hi there! Mike, could you share updates on Afrezza's commercial side? Are there notable changes impacting your performance there?

We’re working toward a coordinated approach within our sales teams across all territories so that everyone is aligned with the same operational focus. That creates an environment where our managers are empowered to effectively run their territories. Additionally, we’re in a position now to invest in high-ROI opportunities, and we’ve started to see promising results from a recent large digital marketing campaign scaled outside of the testing phase.

Thank you for that insight. What presentations or key focuses could we expect to see from you at ADA?

The upcoming ADA conference will prominently feature our studies involving CGM with Afrezza, particularly around nocturnal hypoglycemia and time in range. It's crucial to note that the FDA currently does not associate these metrics with positive patient outcomes, but we think the innovative data we have collected will present an opportunity to demonstrate Afrezza's superior effects in improving patient care. We're excited about sharing these findings.

From our perspective, Afrezza's cost of goods will remain at the same levels we saw in 2020. However, as we begin scaling-up manufacturing for Tyvaso DPI this year, there will be some shifts in costs within our operations.

Overall, we’re in a solid financial position. We're proud of the work being done to transform MannKind from a struggling company to one positioned for sustainable growth over the coming years. Thank you for your time, and we look forward to your questions.

And that does conclude today's question-and-answer session. I'll now turn the call back over to Michael Castagna for any additional or closing remarks.

I extend my gratitude to all the analysts for your coverage, insightful questions, and contributions. Your comments greatly influence our path moving forward. A special thanks goes to our employees, as we've faced a challenging journey. We laid out a strong foundation focused on commercial infrastructure helping us move past COVID while enabling us to take significant leaps forward in various therapeutics. I am proud of our staff's determination under trying circumstances. Thank you, everyone, and I wish you a great day ahead.

And that concludes today’s conference. We thank you for your participation. You may now disconnect.