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Earnings Call Transcript

Mannkind Corp (MNKD)

Earnings Call Transcript 2020-06-30 For: 2020-06-30
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Added on April 28, 2026

Earnings Call Transcript - MNKD Q2 2020

Operator, Operator

Good day, everyone. Welcome to the MannKind Corporation Second Quarter 2020 Earnings Call. As a reminder, this call is being recorded on August 5, 2020, and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call until August 19, 2020. 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-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 things over to Mr. Castagna. Please go ahead, sir.

Michael Castagna, CEO

Thank you and before I start, I really want to say thank you to all of our stakeholders as Q2 was a big unknown for everyone when we look back to March. We weren’t sure how bad revenue or our taxes would decline, or how our cash position would be impacted or TreT would be slowed down and for how long. Our team, whether it be HR, finance, R&D, manufacturing, medical, or sales, pulled through big time, as we will discuss here on our earnings call today. And we are now finally in a very solid financial position, as we look ahead. I’m very excited about our future, whether it be the international expansion, TreT filing, the Phase 1 data readout from COPD, and the incredible foundation of Afrezza we can build our future growth upon. Interest in MannKind is very high right now, and our bench of diabetes expertise continues to grow each day. Thank you again to our employees, our patients, our customers, and our shareholders for hanging in there during what could have been one of the darkest periods in the history of the company. I want to remind people our mission, which is really to give people control of their health and the freedom to live life. None of us today, more than ever, want the freedom to get out of our house and live our life. Hopefully, as we continue to grow our expansion within the Treprostinil franchise, and the Afrezza franchise, we can bring this to more people in the future. Let me highlight some key updates here during Q2. First, Afrezza’s quarterly net revenue of $7 million was 15% ahead of 2019. Our sales to Biomm were $0.2 million in that number and then COVID continues to impact the Brazil launch, as they’re the second worst COVID impacted nation, followed by India. Our U.S. TRx were only down 3%. If you told me back in March that we’re only going to drop 3% in the quarter despite the pull ahead that we had during Q1 in prescription demand and fulfillment, I wouldn’t have believed you. Our team did a fantastic job and we can see that we grew 11% versus Q2 of 2019. Our United Therapeutics collaboration, we were able to receive our third milestone, the $12.5 million in May. We expect another payment later this year during Q4. COVID-19 did delay the clinical trials, and we are all now opening back up for a moment as I’ll talk about in a few minutes. As for our cash balance, we ended Q3 stronger than ever with our second-best quarter at $53.5 million in the last four years. Our cash burn should be manageable for the rest of 2020, given the $12.5 million payment we expect in Q4. We can now invest to grow further faster, as I’ll discuss in our second half opportunity. I apologize, my slides were out of order here. But before I go ahead on the cash balance, I want to introduce Alejandro. I want to announce our new Chief Commercial Officer, Alejandro Galindo. He joins us as the former President of Medtronic Diabetes. He has a great wealth of knowledge and experience in the Type 1 space, technology and medical devices, CGM and pumps, and had a very successful tenure during his five years at Medtronic. He also comes from a background in GE Healthcare, which was a company I followed over the years along with their ups and downs. Alejandro is a tremendous leader, and I’m really looking forward to having him as part of our management team and leading our commercial efforts as we go forward. His background in Spanish and Portuguese and multilingual abilities are really going to help us as we continue to move forward with our international expansion, and as world knowledge of markets is going to be important as we advance. I want to apologize for the miss. We ended the quarter with the debt change here; the PPP loan was $4.9 million as we disclosed in the past. We’ve also repaid our promissory note to one of our debt holders of $2.6 million as scheduled in June. Now, I want to talk about our business transformation during COVID. Our primary concern was our employees and making sure they are well, safe, and protected. We worked from home and used technology within a week of making this transition. Second, we had to ensure we had adequate supply of Afrezza and kept TreT on track. Within manufacturing, we were able to keep the facility open, limiting it to essential workers only. We built inventory for the remainder of 2020, so that we have no risk in patient stock-outs. Third, we focused on sustaining our future. We made a lot of tough choices during Q2 to reduce our spend to offset the expected sales impacts from COVID-19. I will say things turned out way better in Q2 than we had expected. We did take proactive measures to reduce compensation by 20%. We were able to receive the PPP loan, which allowed us to keep all of our infrastructure intact and avoid any furloughs, which we believe were critical to the success we had in Q2, as the alternative would not have been ideal. We spent a lot of energy building this team up, and the PPP loan helped us stay on track and focused. Our TreT collaboration—our temporary suspension of clinical trials caused concern for everybody. But I will say MannKind and United Therapeutics worked very closely together to maintain the momentum and support our clinical milestones as best we can. Finally, Afrezza, let me talk about what we’ve done with Afrezza here during COVID. We quickly pivoted our business model as safer-at-home orders were implemented across the U.S. First, our biggest investment in the field was to ensure we were as impactful as possible, as they moved to remote sales support positions. We trained them on inside sales best practices; we created email templates to enhance their communication with customers; we created digital versions of all our marketing materials; we had over 800 virtual launches during this time; and we launched several training initiatives to ensure their clinical impact as they got back out selling. At the same time, we expanded our sales force during COVID, so that we could emerge stronger than ever. Finally, we were able to create a virtual DreamBoat training. DreamBoat, for those who don’t know, is our Afrezza device. We trained patients virtually to keep new starts going. As far as our commercial operation, we were able to ship FEV1 devices to patients to ensure that they could start Afrezza if doctors decided to, given that many visits and new starts were down during the quarter for many companies. We altered our sampling program, which not only reduced costs but increased customer service and our new patient conversions at lower costs. Finally, we launched several digital marketing campaigns and hosted webinars. We had over 17 webinars with 22 thought leaders reaching over 1,000 physicians in the last four months. The team really executed on the commercial side, despite the challenges from COVID-19. The results in the quarter speak for themselves. We stabilized TRx’s relatively well, with a drop of only 3%, but our revenue decreased slightly more due to a decline in channel inventory, which Steve will discuss. When you look at our new patient starts, while they were down from Q1, they began to rise above 300 as we exited Q2. We believe that as we look forward to Q3, we will see continuing improvements in TRx. We're seeking ways to innovate our business model, one being growth in specialty pharmacies, which will help improve margins as we progress. From Q1 to June, our sales through specialty pharmacies rose from 7% to 16%, and continue to grow each month. We don’t have guidance on where this will plateau, but we see it as a means of providing higher quality service to our patients and our providers through our specialty pharmacy network. I stress that this is critically important to our future, and it will help enhance our margins. On TreT, the good news is it remains on track, as we've discussed approximately a Q1 2021 filing. This is under United Therapeutics' control. Everything we’re doing is to ensure we hit these key milestones. First, the BREEZE trial is a critical part of this package, with 45 patients needing to be switched for 3 weeks. This trial is back up and enrolling, with a long-term extension phase in play. Seven sites are currently operational, and a total of 26 sites are expected to be active soon. This trial should conclude in the latter half of this year. Next is the Pivotal PK trial, which was almost complete during COVID; we are about 5 or 6 patients away and expect it to be completed very shortly. We currently don’t foresee any risk in the Pivotal PK output or trial design. The human factors studies, which are under our control, are looking positive. It’s something we’ve done many times here with Afrezza, and that will kick off in Q3. We have received feedback from the FDA that we incorporated and are looking to launch soon. Finally, the stability program is something MannKind has worked on for the past year, where we upgraded a manufacturing plant, ran commercial batches, and completed stability testing. This will wrap up in Q4 as well. We are excited about our future partnerships, continuing to seek opportunities to collaborate on other molecules, and the potential for TYVASO's expansion in COPD is also on the horizon. I'm going to stop there and turn it over to Steve.

Steve Binder, CFO

Thanks, Mike, and good afternoon. I’m pleased to review our second quarter and first half 2020 financial results, which showed meaningful Afrezza net revenue growth, even with the impact from the pandemic, gross margins holding steady at just under 50%, and our cash balance ending the second quarter at its highest level since December 2018. I’ll be discussing select financial highlights and supplement this call by reading the condensed consolidated financial statements and MD&A contained in our 10-Q that was filed with the SEC this afternoon. Let’s start looking at revenues for the second quarter and the first half of 2020. Starting with the table on the left, Afrezza net revenues were $7 million for the second quarter versus $6.1 million for the corresponding quarter of 2019, a growth rate of 15%. The second quarter included $0.2 million of sales to our Brazilian marketing partner, Biomm. Afrezza net revenue grew 12% versus the prior year driven by volume growth from underlying Afrezza prescription demand, which is up 11%. Price and a favorable mix of cartridges were partially offset by the impacts of the COVID-19 pandemic. The pandemic affected our second quarter Afrezza net revenue in a number of ways. First, we disclosed in our Q1 earnings call that approximately $0.5 million of Afrezza net revenue shifted from Q2 to Q1 due to increased wholesale buying patterns in March. The high wholesale inventory levels on March 31 came back down by the end of the second quarter, negatively affecting second quarter Afrezza net revenue by approximately $0.5 million. Second, our sales force worked from home during the second quarter, and physicians had limited access to their offices, impacting the effectiveness of our selling efforts. Third, the effect on new prescriptions being written by physicians was significant; some patients were reluctant to visit their physicians to minimize exposure to the virus, and some physicians moved towards telehealth, which impacted new patient starts. As Mike explained earlier, we quickly pivoted our business model during the pandemic to enable us to be better positioned for success in this new environment. We believe that a combination of business model changes and the gradual return to normalcy will further support prescriptions in Afrezza revenue for the second half of 2020. Looking at the first half comparisons on the table to the right, Afrezza net revenue grew 35% versus the first half of 2019, driven by volume and mix, which is up 30% and price up 5%. Analyzing both the first and second quarters together helps eliminate fluctuations in the timing of wholesale purchases. Growth nets were at 41% for the second quarter, slightly favorable to our expected range of 42% to 44%, with first half growth coming in at the lower end of the range at 42%. Revenue from collaboration services were $8.1 million in the second quarter of 2020 versus $8.9 million for the corresponding second quarter of 2019. The reduction in revenue was expected, mainly due to the recognition of a $10 million United Therapeutics research agreement from the fourth quarter of 2018 to the second quarter of 2019, with our performance obligations substantially completed. Since inception, we have recognized $53.6 million from the United Therapeutics license agreement and the entire $10 million from the United Therapeutics research agreement for a total of $63.6 million recognized to date. The next slide shows how our product mix continues to favorably impact our Afrezza revenue growth. Our successful commercial messaging and execution resulted in patient titration to higher doses, giving a 12-unit cartridge growth rate faster than the 8-unit and 4-unit cartridges. Reminder, a 12-unit cartridge is priced at two times the 4-unit cartridge. We have the 4-unit equivalent cartridges on the slide to facilitate easy growth rate comparisons in the first half of 2020 versus 2019, showing the favorable impact on Afrezza revenues from cartridge mix. Moving to Afrezza gross profit and gross margin. The table on top illustrates gross margins from the first quarter of 2019 to the second quarter of 2020. Our gross margin was 47.4%, essentially flat with the first quarter of 2020. We have had and continue to have excess manufacturing capacity, resulting in our cost of goods sold remaining relatively flat quarter-to-quarter since production volumes remain lower than our production capacity, meaning most of the manufacturing expenses are recognized as cost of goods sold in the quarter incurred. Since TreT clinical product production ramped up in 2020, we are now capable of absorbing costs of the two products being manufactured at the Danbury site, resulting in a favorable impact on Afrezza cost of goods sold compared to the prior year. Cost of goods sold, excluding inventory write-offs, was $3.7 million for the first and second quarters of 2020, compared to the first quarter of 2020, which included an inventory write-off of $0.5 million, resulting in a higher COGS charge of $4.2 million. The table on the bottom of the slide shows Afrezza gross profit growth of 156% between the first half of 2020 and 2019, primarily resulting from Afrezza revenue growth and a lower level of cost of goods sold, driven by manufacturing efficiencies. As Afrezza revenues increase and cost of goods sold remains relatively flat in the near term, we expect to see increases in both gross profit and gross margin. Moving on to operating cash efficiency. In the next slide, we’re comparing the first half of 2020 versus 2019 and 2018. The top of each vertical bar is Afrezza net revenue, which has more than doubled each year. The bottom reflects non-GAAP net cash used in operating activities, adjusted to exclude the United Therapeutics milestone and the shippers license payments. We’ve reduced operating cash burn by 37% in the first half of 2020 versus 2019, along with an additional 14% when comparing to the previous year. The increase in Afrezza net revenue helps drive down cash burn, but it’s primarily due to our focus on managing operating spending, which we’ve reduced to $27.4 million in the first half of 2020. Our unrestricted cash balance at the end of June for the last three years is shown at the bottom of the slide. We concluded the second quarter with $63.2 million in unrestricted cash and cash equivalents, our highest cash level in 18 months. Besides lower cash burn during the second quarter, we received the United Therapeutics milestone payment of $12.5 million, an $11.6 million from the exercise of outstanding warrants, $11.6 million from equity sales to the ATM, including sales to a strategic institutional investor, and $4.9 million from the PPP loan. Wrapping things up, we experienced headwinds from the COVID-19 pandemic impacting our second quarter results, but we positioned the company for success in adapting to this environment, allowing us to weather the uncertainty caused by the pandemic. Our improved cash position enables the company to navigate the changing landscape as we continue to take appropriate actions to keep MannKind on track for all stakeholders. Thank you. I’ll now turn it back over to Mike for some additional comments.

Michael Castagna, CEO

Thank you, Steve. Now let’s talk about growing our future, not just in the second half, but as we continue to look out going forward. First, I think we were able to do during COVID was to reconnect with many existing shareholders, but also reach out to new ones. This has been important to us, and as we continue to transition our narrative from an Afrezza story to a pipeline and expansion story, we believe it’s crucial to build up our investor base. As part of that, we’ve actively reached out to several new institutional investors, as Steve highlighted, some of whom bought into MannKind through the ATM program. Our investor discussions have been a two-way street; we share our story and reasons to believe in our future but have also listened to their feedback on key areas of concern, for instance, on the Salter padding. We were surprised at how unfamiliar new investors were with our story, and we’ve categorized our investors into two buckets—those who have been with us on Afrezza since our onset, but dropped off years ago, and those who are interested in our growth potential with TreT and further developments as we move forward. We’re beginning to see two distinct bases of shareholders forming, which will converge into a compelling growth story for the company, whether that be fueled by interest in Afrezza or the potential growth related to TreT. In summary, we’re very excited to implement the next phase of our strategy that we rolled out in January, which includes seeking opportunities in lung and endocrine areas to supplement and accelerate our pipeline. We've had positive discussions with institutional investor assets under management over $250 million, as well as with small family offices interested in our growth story. These discussions have been highly productive, and we’ve also engaged in fruitful conversations with current and new research analysts. One key question I've consistently encountered from investors and potential analysts is; why do we continue to invest in Afrezza? This remains an important inquiry, and our response is informed by research during COVID. We reached out to some of the leading insulin prescribers who haven’t yet tried Afrezza, aiming to understand their perceptions and correlating data. The positive takeaway is that, despite our hard work, there is substantial room for improvement. Afrezza continues to address unmet needs for mealtime control, as 80% of patients remain uncontrolled. Recent T1D Exchange data indicates outcomes for Type 1 diabetes patients have gotten worse over the last decade, even as CGMs and insulin pumps have seen increased adoption. This data hasn't changed much in the last 20 years, with roughly 20% of people remaining under control. We believe we have an opportunity to further enhance our offerings, supported by data related to hypoglycemia, dose titration, and weight loss. Where do we go in the second half of 2020? I want to acknowledge David Kendall’s departure from the MannKind family to pursue other interests. His impact will be long-lasting, and I thank him for everything he’s done for our patients and the company’s future. David will assist in the transition period as he embarks on his next opportunity; he is also the lead author on several scientific publications. Despite his departure, we're confident in the strong leadership of our new commercial and medical teams, which have extensive expertise in diabetes. We’ve made two significant hires in the last 24 hours, with three to five more expected next week. From what I’ve learned in advisory boards, there is a significant opportunity to educate providers on our clinical data, and we intend to increase our share of voice. We are expanding our sales force and increasing our medical presence as we speak. We've made solid advancements with Alejandro joining us and additional experts from other diabetes companies, providing a well-rounded diabetes team moving forward. We are also developing steps for an integrated care model, which means creating a streamlined, closed-loop system for patient reimbursement. With the acceleration of telehealth due to COVID, we've recognized a valuable opportunity to partner with others and launch a telehealth platform as early as Q3. Additionally, we’re enhancing our distribution model through specialty pharmacies and other partners to reduce costs further. We're looking to hire a head of R&D to bolster our R&D platform as well. Lastly, I want to mention the launch of BluHale for healthcare providers; we just received the necessary batteries from China and the devices are prepared. We’ll be launching very soon with our sales force, and we’ve organized a team to accelerate the rollout. Alejandro's background will be invaluable here. Regarding collaboration with United Therapeutics, we can expect to receive our fourth milestone in Q4. We will finalize our clinical constraints and support work for the NDA, while also looking to enhance relationships with Cipla, Biomm in Brazil, and other international markets as we develop. On the pipeline side, we’ve commenced Sumatriptan toxicology work, anticipating a pre-IND submission by Q1 next year, and we’re excited to continue pushing our pipeline forward. I won’t delve into detail on the next slide, but it’s crucial to highlight that we’ve had over 24 scientific disclosures over the last 12 months, from December 2019 to December 2020. Three of these publications have been released recently, with another anticipated in the following week. The team has worked diligently to bring forth data that has remained unused in our archives for years, and it's vital that providers understand this information. This necessity is a primary driver for expanding our medical team. Most importantly, I want to convey our excitement about the upcoming pediatric study, which is nearing completion of its Phase 3 protocol design. We plan to approach the FDA in the second half of the year and will kick off that trial in 2021. I want to stop here and open up for questions, while again expressing gratitude for every team member's outstanding effort during this last quarter. I’m very pleased with our teamwork and the way we’ve overcome challenges to make this company stronger after COVID.

Operator, Operator

We’ll hear first today from Thomas Smith with SVB Leerink.

Dylan Dupuis, Analyst

Hi, this is Dylan Dupuis sitting in for Tom. A couple of quick questions, first, can you give us a little insight into what your expectations are for the new territories and the new sales reps that you brought online over this year? What are your expectations and how quickly can they ramp up and produce at full speed? Then, related to this, what target points and metrics are you evaluating to consider opening new territories in the future? I have a couple quick follow-ups after this.

Michael Castagna, CEO

Okay, I apologize. I missed your first question...

Steve Binder, CFO

New territories in sales, what are the expectations for the new territories – and new sales team...

Michael Castagna, CEO

Yeah. I think that the first thing, as you think about, we opened up 11 states and those reps are just getting out there, really the last month, meeting their customers for the first time. When you think about those 11 states, we don’t expect a rapid uptake in the first month, as it's essentially launching from scratch. I can tell you, I was on a call recently with one of the city organizations, and it’s amazing to me that their knowledge base is lacking by about four years, missing all the new information we’ve published. So the first step is to ensure those new territories are supported with solid medical backing. We're providing the employees the necessary resources to be successful, and they're achieving some early success in these territories, so they are growing. However, starting from a base of zero is challenging. I think the principal metric of success we’re observing is really new prescriptions; it’s our earliest indicator of success. Early results are encouraging, and we’ll evaluate this as we reach the end of Q3 and Q4 to determine if we can expand territories further in 2021 and to assess our growth in the second half. Overall, we need to remain cautious with investments given the cash we're fortunate to have through Q2, while also understanding the time needed for training. We’re excited; the new hires have been impressive, with four out of nine new managers in the field, and we’ll likely have 19 new representatives this year, an improvement of 35%. We feel very good about this and are enthusiastic about the metrics we’re observing. In support of the medical team, we aim to hire three to five MSLs as we speak.

Dylan Dupuis, Analyst

Yeah. Great, thank you. And then, real quick, if you can give us an update on the progress being made with AMSL in Australia, as well as the pediatric program. That’d be appreciated.

Michael Castagna, CEO

I heard AMSL in Australia and pediatric program. So, on ASML, I was just on the phone with them a week ago. They, obviously, were hit by COVID, and operations were shut down. They’re just coming back now. We are working on the filing and are finishing up any gaps in the filings regarding modifications to prepare them for submission. So that’s on track now to proceed. It may take about 18 months from the time it's filed. Regarding the pediatric study, we are actively engaging in a few initiatives. First, we’re conducting market research to gather insights from patients and providers on unmet needs in the pediatric space and assessing potential endpoints for our trial. We aim to get a comprehensive forecast for the pediatric segment’s potential for inhaled insulin. Overall, we feel optimistic and want to ensure we consider provider feedback regarding the excitement surrounding this. The second initiative involves conducting pediatric advisory boards to gain direct input on the protocol design and endpoints. We want to securely craft this trial for efficient enrollment while balancing risk and assessment to ensure the swiftest pathway to launch. The third element is building our network of pediatric thought leaders. We recently hired a commercial team member with a deep diabetes background from Novo and Lexicon, who will be pivotal in establishing our presence in the pediatric segment. Alejandro's connections in pediatrics are also invaluable. We recognize this will require some time but are committed to setting the right groundwork for a successful launch, preparing our approach as we turn our focus to the pediatric market. Currently, we are ensuring all the right plans are put in place to accelerate the launch of that trial.

Dylan Dupuis, Analyst

Yeah, great. Thank you very much.

Brandon Folkes, Analyst

Hi, thanks for taking my questions and congratulations on all the progress in the quarter. You mentioned how quite significant telehealth will be as a growth driver moving forward. Can you just share feedback you’ve heard from physicians regarding switching patients in the current environment? Do physicians want to see patients in person? If so, how often? Additionally, can you describe positive shifts in business processes you’ve observed due to COVID that you consider tailwinds for the company moving forward? Thank you.

Michael Castagna, CEO

Thank you, Brandon. Initially, when COVID hit, everyone was trying to determine how to survive. One possible benefit MannKind experienced is that a lot of our business is with private practice owners, who were the first to reopen, allowing us to establish more interaction compared to our industry colleagues. That differs from academic centers, where the situation changes. Initially, all of us, including MannKind and other businesses and physician offices, were focused on keeping patients engaged, maintaining therapies, and implementing minor adjustments. That’s where telehealth came in handy. Once it became evident that COVID would persist beyond the initial four weeks, we began seeking feedback on whether it’s feasible to initiate new patients virtually with Afrezza. We inquired about spirometry and dose titration as part of the process. Fortunately, we received over 100 requests for FEV1 devices from providers who, while shut down, still managed to secure virtual new patient starts. This offered us confidence in the possibility of telehealth functioning as a part of our business expansion, which is why we are excited about it. Offering telehealth was initially met with some hesitation, as many physicians indicated that if a patient requested it, they could start them during COVID. However, they were less interested in executing many patient switches during that time. I believe that sentiment was prevalent about a month or two ago, but right now, new starts are climbing back. In our weekly script analysis, as well as feedback from our representatives, it’s clear that things are moving in the right direction. California and Florida may be slower to catch up compared to Texas, but New York is effectively back up and running, as are New Jersey and Boston. Overall, we’re optimistic. So, to recap, during COVID, we learned the potential of starting patients virtually. As we emerge from COVID, we see the potential for growth from both in-person and virtual channels, which is significant.

Brandon Folkes, Analyst

Right. Thank you very much.

Robert Hazlett, Analyst

Yeah. Thanks. My congratulations on your meaningful progress in challenging environments; things are clearly moving in the right direction in a number of ways. Regarding TreT and the collaboration with United Therapeutics, could you provide more details on the current state of manufacturing? You mentioned how that’s helping overall gross margins. However, any additional timelines regarding manufacturing efforts for TreT would be helpful?

Michael Castagna, CEO

Hey, Bert. Not much additional information to share; we built up a manufacturing facility last year, which involved a significant investment in the millions of dollars, and that was with support from UT Health. It’s fully operational now, and we are implementing the same process fee. The team is diligently working to ensure everything is synchronized for our filing procedure, including equipment setup, packaging, and functionality. They’ve been working tirelessly to make sure that all processes are positive, even under challenging circumstances. I want to thank the team for being diligent, as they’ve not faltered despite the hectic environment. We will serve as the contract manufacturer. TreT clinical supplies will also be delivered by MannKind's manufacturing facility. All equipment is installed, stability tests are running well, and everything appears to be going positively. We don’t foresee any significant issues moving forward, and we’re committed to ensuring everything operates smoothly in anticipation of the filing. We feel confident about the process's tightness and the knowledge we’ve gained in the last two years with this collaboration with UT.

Operator, Operator

And at this time, I’d like to turn things back to management for any closing remarks.

Michael Castagna, CEO

I just want to acknowledge our wonderful team’s efforts during a very impressive quarter, even amidst major headwinds. Nobody could accurately predict how things would unfold, especially in March and April. I’m extremely thankful that the team remained resolute, leading to an excellent Q2 outcome. We’ve positioned the company to leverage our financial resources for growth. The diligent contributions from our talented new hires are invaluable. Thank you once again; your dedication keeps us moving in the right direction. I look forward to our continued progress and building a robust future for Afrezza as a primary treatment for patients with diabetes. We’ll be engaging in several investor conferences in September, as well as some in between. Looking forward to sharing more with you then. Thank you once again for your unwavering support. Let’s see how Q3 unfolds; we’re very optimistic about our trajectory and the collaboration of all our teams to ensure success.

Operator, Operator

And that will conclude today’s conference. Again, thank you all for joining us.