MannKind's Q3 2025: Contradictions Emerge on Furoscix Expansion, Pricing, Afrezza Pediatric Launch, and IPF Study Timelines

Business Commentary:

• Revenue Growth and Strategic Acquisitions:
• MannKind Corporation reported a record revenue of $82 million for Q3 2025, up 17% year-on-year.

• The growth was driven by strong performance from Tyvaso DPI and the acquisition of SC Pharmaceuticals, which added Furoscix to its portfolio.

  

• Clinical Development and Market Expansion:

• The acceptance of the Afrezza supplemental BLA for review with a PDUFA date of Q2 2026 indicates progress in expanding the company's product offerings.

• This opportunity is part of MannKind's strategy to unlock the full potential of Furoscix and advance inhaled bumetanide for fluid overload and CKD.

• Commercial Performance and Strategic Investments:

• Afrezza grew 31% in new prescriptions and 27% in total prescriptions year-on-year, reflecting a focus on type 1 diabetes in preparation for pediatric expansion.

• Continued investment in sales and marketing efforts, including an expanded field force, supports growth in Afrezza and Furoscix.

• Financial Impact and Integration:

• Furoscix revenue reached $47.1 million for the year to date period, a 95% increase over the same period in 2024, with Q3 unaudited revenue at $19.3 million.
• The acquisition of SC Pharmaceuticals is expected to strengthen MannKind's commercial scale and align with its strategy to expand into adjacent therapeutic areas.

Contradiction Point 1

Furoscix Salesforce Expansion and Integration

It involves the timeline and strategy for expanding and integrating the salesforce post-acquisition, which is crucial for product growth and market penetration.

Is the salesforce expansion for Furoscix ongoing? How will Furoscix’s addition impact Q4 SG&A? - Yun Zhong (Wedbush)

2025Q3: We are finalizing expansion plans but expect it to focus on key account managers. SG&A will include commercial and administrative costs from SC, with synergies realized as a public company. - Michael Castagna(CEO)

What is the typical Afrezza patient profile today and how has its use evolved? - Brandon Richard Folkes (H.C. Wainwright)

2025Q2: We continue to be very bullish on trying to rebuild our SC salesforce. Look for the announcements of another 20 field reps in the next 1 to 2 weeks. - Michael Castagna(CEO)

Contradiction Point 2

Furoscix Pricing and Market Differentiation

It involves the company's strategy and positioning of Furoscix in the market, particularly concerning pricing and product differentiation, which are crucial for competitive advantage and market share.

Can you comment on recent Furoscix competitor approvals? How do pricing differences impact out-of-pocket costs for patients? When do you expect significant growth inflection from Furoscix initiatives? - Olivia Breyer (Cantor)

2025Q3: The key focus is our product differentiation and lifecycle management. Pricing differences won’t change the biggest barrier—Medicare out-of-pocket costs. The net price to the patient is crucial. We are competitive, and expansion of the salesforce will drive growth. Share of voice and customer engagement are key, with expansion planned for 2026 to impact growth. - Michael Castagna(CEO)

What's the rationale for the adult label update for Afrezza, and how will it affect uptake? How do you see the macro impact on the supply chain? - Anish Nikhanj (RBC)

2025Q1: We are not changing the pricing. We're keeping the price the same. It is to keep the price in line with the competition. Obviously, you'd like to be a little bit lower, but it just doesn't make sense to try and undercut it. - Michael Castagna(CEO)

Contradiction Point 3

Afrezza Pediatric Launch Trajectory

It involves differing expectations for the timeline and market share of the Afrezza pediatric launch, which is a strategic growth initiative for the company.

How do you balance investment in Afrezza peds and Furoscix, deleveraging the balance sheet, and maintaining operational profitability? - Faisal Kashid (Leerink)

2025Q3: We are preparing for Afrezza Pediatric launch... Deleveraging is a priority, targeting the $36 million convertible note due in March 2026. - Michael Castagna(CEO)

How are you assessing Afrezza's pediatric market potential? - Anish Nikhanj (RBC Capital Markets)

2024Q4: Our goal is to hit 10% market share in pediatrics within 12 to 24 months. - Michael Castagna(CEO)

Contradiction Point 4

IPF Study Timeline and Design

It involves the timeline and design of the IPF study, which is crucial for the development and regulatory approval of MannKind's IPF treatment, potentially impacting market access and revenue.

What is the timeline and potential similarity between the Tyvaso bridging study in IPF and the BREEZE study? - Olivia Breyer (Cantor)

2025Q3: UT has indicated it could be a BREEZE-like study. They will likely pursue FDA discussions after the TETON 2 results. Timing depends on UT but is expected to be swift. - Michael Castagna(CEO)

Is the Tyvaso IPF bridging study an inferiority study, and what is the timeline? - Olivia Brayer (Cantor)

2025Q1: It's too early to comment, but we believe it will be a superiority study. We'll discuss further after TETON 2 results and refine our plans. We expect more clarity in the coming quarters. - Michael Castagna(CEO)

Contradiction Point 5

Furoscix Market Expansion and Salesforce Strategy

It includes differing strategies and timelines for expanding the salesforce and market penetration for Furoscix, impacting revenue growth expectations.

Is there an ongoing salesforce expansion for Furoscix? How will Furoscix's addition affect Q4 SG&A expenses? - Yun Zhong (Wedbush)

2025Q3: We are finalizing expansion plans but expect it to focus on key account managers. - Michael Castagna(CEO)

Are pipeline expansion opportunities a priority, and how do they align with current goals and cash stability? - Paisal Khurshid (Leerink Partners)

2024Q4: We are focusing on clinical supply, manufacturing scale-up, and TYVASO expansion, in addition to exploring new molecules for future development. - Michael Castagna(CEO)