MANNKIND CORP Q1 FY2025 earnings call

Endocrine Business: - Endocrine business grew 20% on NRxs and 14% on TRxs. Filed for a label change for adult (2x round down conversion) expected to be approved in Q4 2025, plan to file pediatric expansion in mid-2025. ### Tyvaso Collaboration: - Tyvaso collaboration remains strong with Q1 royalty revenue of $30 million and manufacturing revenue of $29 million. Previous four quarters had about $1.1 billion of Tyvaso DPI related revenue from United Therapeutics, with 10% royalty on those sales. ### Clofazimine and Nintedanib: - Clofazimine: NTM market likely to exceed $1 billion by end of decade, focus on US and Japan. Inhaled clofazimine aims to maximize antimycobacterium activity at site of infection, bypass GI tract, and has convenient dosing cycle (28 days on, 56 days off). MannKind 101 study: 85% of sites activated across four countries, 55 patients randomized with minimal dropouts, patients moving past six-month time point. - Nintedanib: IPF is a progressive and fatal disease with few treatment options. Phase 1 study complete, met safety and tolerability objectives in healthy volunteers. Expect to continue development in global trial. ### Afrezza: - Successful ATT showing with positive reception, global expansion and demand opportunity real. Top 50 prescribers had 26% year-over-year growth. Financial results strong with non-GAAP income of $22 million, 43% growth over last year.

The endocrine business grew 20% on NRxs and 14% on TRxs. The Tyvaso collaboration had Q1 royalty revenue of $30 million and manufacturing revenue of $29 million. Afrezza net revenues for the first quarter were $15 million, a 3% increase over the prior year. V-Go net revenue was approximately $4 million for the first quarter, a 6% decrease. Tyvaso DPI royalties contributed $30 million in the first quarter, an increase of 32% over the same quarter last year. Collaboration and services revenue was $29 million, an 18% increase from the prior year quarter.

Royalty Revenue: Expect royalty revenue to continue growing based on Tyvaso DPI's performance. ### Collaboration and Services Revenue: Expected to remain relatively flat in near term due to production scale up and efficiencies, fluctuate based on UT's production orders. ### Afrezza: Anticipate change in growth trajectory, especially with pediatric indication approval. ### Catalysts: - INHALE-1: Last patient enrolled, top line results shortly, sBLA in next few months. - MNKD-101: Confident in achieving 100 patients in interim analysis by end of 2025. - MNKD-201: Finalize details for global trial, kick off in second half of 2025. - Tyvaso: Every 10,000 patients covered on insurance could mean $300 million to $350 million in revenue between manufacturing and royalties. Endocrine business: Every 10% share in kids could represent about $150 million in net revenue.

Tariffs: Impact on supply chain for Afrezza, Tyvaso DPI manufacturing, and pipeline programs like MNKD-101 and MNKD-201. ### Regulatory Uncertainties: Uncertainties with trial results and regulatory approvals for label changes, pediatric expansions, and new drug trials.

Q: Regarding MannKind 201, provide initial thoughts on Phase 2/3 trial design and FDA feedback.

A: Not given much guidance on FDA feedback yet. Phase 2/3 design for global trial, thinking several dose arm trial compared to placebo, discussing last minute points like on top of pirfenidone or naïve patients.

Q: On MannKind 201 Phase 2/3 trial design for IPF, endpoints, dose levels.

A: Looking at a couple doses, finalizing protocol, looking for delta from placebo, not scaling for distinct statistical endpoint but aiming to enroll enough patients.

Q: On Tyvaso IPF data, bridging study between DPI and nebulized formulation.

A: Too premature to comment yet, UT and MannKind will discuss shortly, defer to UT for initial thoughts.

Q: Label update for adults in endocrine business, rationale and uptake.

A: Dosing change to better conversion dose leads to better timing range, expecting label change approval in Q4 2025, potential upside growth in adult uptake.

Q: Supply chain impact on Afrezza, Tyvaso, pipeline programs.

A: Predominantly US manufactured, minimal impact from tariffs currently, V-Go supplies slowed down to minimize impact.

Q: MNKD-201 in IPF treatment landscape, device platform.

A: Inhaled nintedanib could be background therapy for new drugs, same device platform as used in PH/PH-ILD market will be used, starting with jet nebulizer for clofazimine and looking to fit dry powder into Dreamboat platform.

Q: Afrezza NRx vs TRx growth, cause.

A: Combination of new data and sales force execution, strong education campaign around INHALE-3 data set in Q4, Q1 continued progress.

Q: Pediatric Afrezza strategy, adherence.

A: Different strategy from adult, impede doctors more progressive, parents diligent, teenagers show high adherence, focus on consumer approach and supporting patients in schools.

Q: Pipeline capacity and CapEx.

A: Danbury facility has high capacity to scale up, plenty of equipment for pipeline programs, most CapEx already behind us, no major CapEx expected in next five years unless buying new equipment.