Earnings Labs

MannKind Corporation (MNKD)

Q3 2021 Earnings Call· Tue, Nov 9, 2021

$2.80

+6.27%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

+0.21%

1 Week

+1.67%

1 Month

-8.54%

vs S&P

-9.23%

Transcript

Operator

Operator

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 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 our 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.

Michael Castagna

Management

Good afternoon, everyone. And I apologize for that delay. We were having a problem with the audio and couldn't quite figure out who's end it was. So I do apologize, and we'll jump right in and I'll try not to speak faster than [Indiscernible]. Equivalent, let's talk about our operational highlights, where we've been, and where we're going. First, I want to thank our shareholders for the support and feedback over the last few months. Obviously, the news received a few weeks ago was not something we expected, but we do think it's something manageable that we'll get through, that we'll talk about. I also want to thank our employees who worked so hard during Q3 to ensure we are executing on our 3 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 really, really happy to see that in Q3 2021, we had $22 million in revenue, which was 45% over last year. And we looked at Afrezza as we grew 34% to $9.8 million over last year. An overall, year-to-date, 35% total revenue growth and 25% on Afrezza. We're really proud of those results, and look forward to continue to drive future growth as we go forward. In the often known area, I want to talk about a couple of things. Number 1, our units of collaboration. I'll talk about the [Indiscernible] on the next slide, but I want to let you know that we've began commercial manufacturing and we continue to hire and expand our facility on Danbury to handle the expected future demand coming of [Indiscernible] 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…

Steven Binder

Management

Thanks, Mike. And good afternoon. Very pleased to review select third quarter and year-to-date 2021 financial results. Please supplement this call by reading the condensed consolidated financial statements, MD&A contained in our 10-Q, which was filed with the SEC this afternoon. Let's start up by looking at revenues for the third quarter of 2021. Afrezza net revenue was $9.8 million versus $7.3 million in 2020, a growth rate of 34%. The components of growth, include the demand increase, consisting of symphony reported paid TRx growth of 16% and price, including a more favorable gross to net percentage of 40% versus 41% 2020. TRx for the third quarter of 2021 and 2020, were both adversely impacted by the COVID pandemic. Year-to-date growth to 25% was driven by simply reported paid TRx growth of 11%, a more favorable mix of Afrezza cartridges and price, including a 2% more favorable gross to net percentage. Moving to collaboration services, revenue for the second quarter was $12.5 million versus $8.1 million for 2020, representing a 54% increase. The increase was mainly due to additional contracted activities associated with our UT collaboration, and a decrease in the recognition period used for the R&D services and licensed performance obligation. The year-to-date revenue from collaboration's and services was 44% or $35.1 million and consists mainly of revenue from our collaboration with United Therapeutics in the amount of $33.5 million. The graph on our next slide, shows the quarterly and September year-to-date Afrezza gross margin on a GAAP basis and on a Non-GAAP basis for September year-to-date, which is adjusted to exclude the expense recorded in the second quarter for the insulin supply agreement amendment fee of $2 million. Our gross margin, has been increasing each quarter during 2021 and stands at 55% year-to-date on a GAAP basis, and…

Michael Castagna

Management

Thank you, Steve. And thank you, everyone else. With the sales impact now closed, you can see the proceeds really are focused on how we can take opportunistic opportunities on Afrezza, which we've not been able to do in the past. Additionally, our pipeline today is robust and growing rapidly. It's growing so fast that we physically cannot do any more than we're doing without hiring a lot more people. For next year, the reason we'll talk about the pipeline is we're not going to talk on another shareholder call probably till March, February when Q4 closes, but there's a lot of positive things happening in the pipeline between now and then, that I really wanted to take a step back for shareholders to have a glimpse of what's coming. On this slide in particular, you could see the cannabidiol, I think they are on Phase 1, they've started and they are looking at acute panic disorder as well as anxiety. They focus on that in their Phase 1. But that's slide is really accordingly. We are pleasantly shocked with this data. We are excited to be sharing this with you for the first time. We know Clofazamine works. So we're already excited about the how we bought it in through our acquisition of Qrum mid-December. But it's really good to see that this effect last 56 days post data, absolutely mainly. So as the new top data just recently got in and we just looked at its high, medium and low dose relative to the minimum and inventory concentration, which is the green line. And from the left side, we dose for 28 days, and then we follow these animals for another 56 days, host dosing, to look at how fast the drug clears, how much will vesting impact…

Operator

Operator

At this time. [Operator instructions] Our first question comes from the line of Gregory Ranexa from RBC Capital Markets. Please ask your question.

Unidentified Speaker

Analyst

Hi, this is [Indiscernible] for Greg. Thank you for taking our questions, and congrats on the progress.

Michael Castagna

Management

[Indiscernible] go.

Unidentified Speaker

Analyst

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

Operator

Operator

Yes, ma'am. I can hear you. [Indiscernible]

Michael Castagna

Management

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

Operator

Operator

Excuse me, presenters, could you hear me.

Michael Castagna

Management

Okay. To our analysts who are on hold, I apologize, we cannot hear you, but we will take your calls and obviously gets you ready for updates after this earnings call today. I apologize for the technical difficulties. It's probably started late and there's obviously a challenge here. I must have jinx ourselves saying how smoothly these eventual fire alarms to where we are. But thank you to everyone. Apologize for that. I know we have a retail shareholder meeting tomorrow. Look forward to that. Obviously, any retail shareholder listening today, email Rose or IR if you want to join that meeting. And any questions, please get those in advances. We're going to try to go through the topics and organized that in a [Indiscernible] type of way. And hopefully we don't have any issues here.

Steven Binder

Management

Hold on. Okay. Thank you for your time.

Operator

Operator

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