MannKind Corporation (NASDAQ:MNKD) Q2 2023 Earnings Conference Call August 7, 2023 5:00 PM ET

Company Participants

Michael Castagna - Chief Executive Officer

Steve Binder - Chief Financial Officer

Conference Call Participants

Steven Lichtman - Oppenheimer & Company

Olivia Brayer - Cantor

Anish Nikhanj - RBC Capital Market

Thomas Smith - Leerink Partners

Oren Livnat - H.C. Wainwright

Anthony Petrone - Mizuho

Operator

Good afternoon and welcome to MannKind Corporation 2023 Second Quarter Financial Results Earnings Call. As a reminder, this call is being recorded on August 7, 2023, and will be available for playback on MannKind Corporation website shortly after the conclusion of this call until August 21, 2023.

This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, 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, Steve Binder.

I would now like to turn the call over to Mr. Castagna. Please go ahead, sir.

Michael Castagna

Thank you, and thank you, everyone. Happy afternoon. So a year ago in Q2, when we were notified that United Therapeutics got FDA approval for Tyvaso DPI, at that time we said that would put us on the path of profitability. And as we kick off a year later, we are proud to say that we’ve achieved our first operating income, making us a long-term sustainable company, which helps us live our mission to ultimately give people control of their health and the freedom to live life. Today, we probably have between 15,000 to 20,000 people taking one of our diabetes products. And there are thousands of people benefiting from Tyvaso DPI. We’re really proud of all the hard work, and we’re really excited to share this quarter’s earnings with you.

Let me first start off by a couple of highlights here in Q2. Orphan lung disease business is off and running. United Therapeutics is doing amazing job, strong patient demand. We received royalty revenue of $19 million or 63% growth just over the first quarter. We also took a step to improve manufacturing capacity through efficiencies and yields, increasing that by about 250%. Additionally, our orphan lung pipeline is starting to come into the purview. We expect to have 2 INDs filed and going into Phase 1 and Phase 3 in the next 12 months. INHALE-101, as we just notified you previously, there was a fire, unfortunately. We are now moving GMP manufacturing to Danbury, Connecticut. And fortunately, we have facilities there where we can move the equipment into. Our chronic tox study is now complete, and we’ll have a full study readout on that here in Q3.