MannKind Corporation (NASDAQ:MNKD) Q3 2023 Earnings Conference Call November 7, 2023 5:00 PM ET
Company Participants
Michael Castagna - Chief Executive Officer
Steven Binder - Chief Financial Officer
Conference Call Participants
Gregory Renza - RBC Capital Markets
Ron Feiner - Oppenheimer
Oren Livnat - H.C. Wainwright
Andreas Argyrides - Wedbush Securities
Operator
Good afternoon and welcome to the MannKind Corporation 2023 Third Quarter Financial Results Earnings Call. As a reminder, this call is being recorded on November 7th, 2023, and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call until November 21st, 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 conference over to Mr. Castagna. Please go ahead, sir.
Michael Castagna
Thank you, DD. Thank you everyone for joining us today. It's been six years since Steve and I became CEO and CFO. We've turned this company from losing well over $100 million a year to our first profitable quarter in our history. We've helped over 20,000 people on a MannKind manufactured product last quarter and our pipeline is moving faster than ever to help more as we continue to live our mission to help patients live a better life.
As you think about our highlights this quarter, we've made great progress on the clinical and financial aspects of our Company. In the orphan lung space, we've seen Tyvaso royalty revenue of over $20 million and manufacturing of $13 million.
On the pipeline, MannKind-101 cannot be in a better position. We came from our last earnings call when we just had learned of a fire in our facility, our partnership in Germany, to successfully moving CMC here in Danbury, and we have manufactured our first clinical batch in record time.
On MannKind-201, our inhaled nintedanib program has continued to progress towards filing an R&D and starting our Phase 1 trial in the first half of '24. Feedback from our quality [ph] users has been very positive on this program and we're excited to get this into humans as quickly as possible. On the endocrine business, we've achieved our first quarterly positive contribution. This is one quarter ahead of our expected Q4 goal. We made $0.5 million in Q3 of this year. That was driven by our Afrezza 24% growth year-over-year.