Release Date: February 26, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• MannKind Corp (NASDAQ:MNKD) reported a 31% increase in fourth-quarter revenues, reaching $77 million, and a 43% increase for the full year, totaling $286 million.
• The company successfully reduced its debt principal by $236 million in 2024, ending the year with a strong cash position of $203 million.
• MannKind Corp (NASDAQ:MNKD) achieved record revenues in its endocrine business unit, with Q4 revenue of $23 million and full-year revenue of $82 million.
• The company has two FDA-approved products on its technosphere platform and is advancing its pipeline with promising candidates like clofazimine inhalation suspension and techev DPI.
• MannKind Corp (NASDAQ:MNKD) announced a collaboration with Anasstar, enabling the promotion of Maximi through its US sales force, which is expected to enhance its pediatric footprint.

Negative Points

• The company faces challenges in launching its pediatric indication, with approval not expected until early 2026.
• Vigo net revenue decreased by 4% over the prior year, and the salesforce is no longer actively promoting the product.
• Despite the progress, MannKind Corp (NASDAQ:MNKD) anticipates potential delays in its India launch due to packaging and shipping issues.
• The company is still working on expanding its institutional selling capabilities, which is crucial for its future growth in the pediatric market.
• MannKind Corp (NASDAQ:MNKD) acknowledges the need for significant investments in its FRSA business, which could impact margins in the near term.

Q & A Highlights

• Warning! GuruFocus has detected 4 Warning Signs with MNKD.

Q: Can you talk about how we should be thinking about margins over the next few quarters, given the investments planned in the FRSA business? A: (Chris Prentice, CFO) Our margins have improved due to the utilization of our manufacturing plant with the build-up of Tibeso DPI and FRSA. These margins are expected to remain steady going forward.

Q: Can you provide more details on the gross to net discounting and rebates for DPI this quarter, and what are the next steps for DPI and IPF? A: (Michael Casanna, CEO) The new norm for gross to net discounting is expected to be consistent with Q4. Regarding DPI and IPF, we have a meeting in Q2 to discuss the bridging study, which is necessary for the US filing. We anticipate these discussions to accelerate soon.

Q: How are you balancing operational profitability with investment in the pediatric launch for FRSA? A: (Michael Casanna, CEO) We have capital to deploy and aim to invest in areas that drive the best return for shareholders. The focus is on launching pediatrics appropriately, alongside ongoing trials for clofazamine and tetanus.

Q: What are the critical success factors for the potential launch of FRSA in pediatrics, and how will the agreement with CIPLA in India contribute to FRSA's topline? A: (Michael Casanna, CEO) Key success factors include ensuring a best-in-class reimbursement hub, institutional selling capabilities, and education and awareness. For CIPLA, we expect to ship our first order by the end of the year, which could improve manufacturing efficiency and COGS.

Q: Regarding the interim analysis for 101, will it look at both co-primary endpoints, and how might the study size change? A: (Michael Casanna, CEO) The interim analysis will occur after 100 patients reach their 6-month endpoint. We anticipate the study size could increase from 180 to 300 patients, and we aim to maintain statistically valid results between the placebo and active arm.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.