MANNKIND CORP Q4 FY2024 earnings call

• Endocrine business unit had record revenues: Q4 at $23M, full year at $82M. Appointed Dominic Marasco as President of EBU. Closed India approval in late 2024, expect launch in H2 2024. Announced Amphastar collaboration in Dec 2024. • Clofazamine inhalation suspension program: Phase III study with 70% sites activated, on track to hit interim enrollment goal of 100 patients by end of 2024. • TETON DPI: Completed Phase I, had FDA meeting at end of Q4, looking to advance to next stage. • Financial results: Q4 revenue $77M, full year $286M. Year-end cash position $203M, reduced debt principal by $236M in 2024. • Diabetes business: Pillars include team building, international opportunity in India, pediatrics (expect to file pediatric indication in H1 2025 with approval in early 2026), and gestational diabetes. • Tyvaso DPI: Revenues over $200M in 2024, Technosphere platform achieved billion-dollar status.

The endocrine business unit had Q4 revenue of $23 million and full year revenue of $82 million. Tyvaso DPI royalties contributed $27 million in Q4, with annual royalties at $102 million. Collaboration and services revenue was $27 million in Q4, with full year 2024 revenue at $101 million. Afrezza net revenue was $18 million in Q4, with full year 2024 revenue at $64 million. V-Go net revenue was approximately $5 million in Q4, with full year 2024 revenue at $18 million.

• Prepare to launch Afrezza in H2 2025. • INHALE-3 pediatric opportunity: Aim to file in H1 2025, with approval in Q2 2026. • 101 study: Expect 90% of sites activated by H1 and meet enrollment goals by end of 2024. • 201: Have FDA meeting scheduled, setting stage for next phase of development. • Travel schedule: Robust, including conferences in March and Amsterdam in upcoming months.

• Market uncertainties related to GLP growth, pump innovation, and competition. • Clinical trial risks such as potential delays in enrollment, analysis, or approval of clofazamine and TETON DPI programs. • Uncertainties around pediatric launch uptake and reimbursement challenges.

Q: Congrats on all the progress. Can you talk about margins over the next few quarters and DPI details?

A: Chris Prentiss mentioned margins are getting to a steady state, with revenue and cost of goods considered. Michael Castagna discussed gross to net discounting being new norm, and bridging study discussions with FDA regarding TETON.

Q: How are you thinking about balancing operational profitability vs investment in pediatric launch for Afrezza?

A: Michael Castagna stated they have capital to deploy and aim to deploy it for best return, with pediatric launch being a key area for growth.

Q: How are you thinking about potential pipeline expansion opportunities?

A: Michael Castagna mentioned working on additional product opportunities, including lifecycle management of Afrezza and clofazamine, with more updates expected later in the year.

Q: As you think about potential launch in peds, how are you thinking about the plotting of the launch trajectory and uptake?

A: Michael Castagna outlined critical success factors including reimbursement hub, institutional selling ability, and education/awareness. On India agreement, expect import manufacturing approval in Q3 and first shipment by end of year.

Q: Can you elaborate on contracting dynamics and updates on 201?

A: Michael Castagna said contracting dynamics are steady state, with FDA meeting in early April for 201 to lay out milestones for next 12-18 months.

Q: If Teton is successful, how should we think about potential manufacturing element?

A: Michael Castagna stated they are ready to handle increased manufacturing capacity if Teton readout is successful, with potential impact on collaboration services revenue.

Q: On the $200 million plus on Afrezza, can you talk about the timeline?

A: Michael Castagna discussed aiming for faster uptake in peds by proper execution, with goals based on market share projections.

Q: Have you heard anything from adult subjects in light of INHALE-3 data and details on 101 interim analysis?

A: Michael Castagna mentioned patient satisfaction in INHALE-3, with 50% wanting to stay on Afrezza, and details on 101 interim analysis after 100 patients reach six-month endpoint, with plans to enroll additional patients while waiting for results.