MANNKIND CORP Q3 FY2024 earnings call

• Tyvaso DPI collaboration continues to be record-setting in revenue and expansion opportunities, with strong collaboration with United Therapeutics.
• Pipeline focus includes nintedanib Phase 1 readout, Clofazamine Inhalation Phase 3 site activations in U.S. and Asia.
• EBU net revenue for the quarter was $20 million (10% vs last year).
• Afrezza had headwinds earlier in the year but looking to accelerate growth in 2025, with 8% growth in NRx year-over-year in Q4 early indicators.
• Strong financial position with $268 million in cash and $15 million in non-GAAP operating income for Q3.
• Clofazamine Inhalation has significant unmet need in NTM lung disease, with Phase 3 site activations ongoing.
• MannKind 201 Phase 1 study was a success with no dose-limiting toxicities or adverse event findings preventing forward progress.
• Diabetes business had 30-week data showing A1c improvement with Afrezza, and readout of those who switched from usual care at 30 weeks.

Tyvaso DPI collaboration: Third quarter revenue was $27 million, a 34% increase year-over-year; year-to-date revenue was $75 million, a 48% increase. Collaboration and Services revenue: Third quarter was $23 million, a 78% increase year-over-year; year-to-date was $74 million, a 108% increase. Afrezza net revenue: Third quarter was $15 million, a 12% increase; year-to-date was $46 million, a 16% increase. V-Go net revenue: Third quarter was approximately $5 million, a 5% increase; year-to-date was approximately $14 million, a 6% decrease.

• Expect to accelerate Afrezza growth in 2025 and beyond, shifting from profitability mindset to growth mindset.
• Pediatric study INHALE-1 readout expected before end of 2024, with pre-NDA filing meeting in first half of 2025.
• INHALE-3 label change and INHALE-1 readout, along with IIT in gestational diabetes in the near future.
• 101 and 201 clinical trials moving forward, with 101 close to final formulation selection and 201 planning to meet with FDA for further development to Phase 2/3 in 2025.

• Competitor failures in NTM space leaving MannKind as one of the few remaining companies investing in NTM.
• Regulatory challenges in getting products through development and approval.
• Market shifts, such as endoswitch from diabetes treatment to weight loss impacting prescribers.
• Side effects related to products, like skin discoloration, QT prolongation, and drug accumulation for clofazamine, and potential GI side effects for nintedanib.

Q: Regarding 101, can you give a sense of ARIKAYCE penetration and where 101 fits in, and for 201, more detail on Phase 1 and timeline.

A: On 101, hope to displace ARIKAYCE in refractory population, with ultimate goal of being used in early and late lines of treatment in NTM. On 201, Phase 1 study showed no GI side effects or concerns, shaping up for Phase 2 with FDA expecting a dose range finding study next year.

Q: What more can you tell us about MNKD 201's profile, differentiation, and PK comparison to oral formulation.

A: Differentiation includes lower systemic exposure and higher lung exposure, Phase 1 study showed no major concerns, and PK data still being analyzed. No direct comparison to oral formulation yet, but focus on reducing GI side effects of OFEV.

Q: Can you say more about adverse event profile in Phase 1 for inhaled 201, like FEV drop and cough events.

A: No consistent concerns around FEV drop or cough events, with no dose-limiting toxicities. Much of the effect seemed related to repeated FEV1 testing required by FDA rather than specific to the tentative.

Q: What's the broader value proposition of 101 economically for patients and physicians, and can 201 be used in PPF.

A: 101 has better safety profile with reduced systemic exposure, better dosing administration, and clinical differentiation from ARIKAYCE. On 201, there's an opportunity for extrapolation of indication, potentially including PPF, but first focus on IPF.

Q: Talk about Afrezza growth, breadth and depth of subscribers, unaided awareness, and commercial footprint evolution.

A: Unaided awareness among doctors is expected, with salesforce reduction leading to focus on targeted prescribers. TRX in rapid-acting mealtime market dropping, but Afrezza has enough prescribers to work with, and plans to broaden commercial focus with MSLs in 2025 to address safety perceptions and efficacy opportunities.