MannKind Sees Early ReadyFlow Demand as Pediatric Afrezza Launch Gains Momentum

Key Points

• FUROSCIX ReadyFlow is showing early demand: Physicians have submitted coverage requests at several times the prior on-body infuser rate, with interest expanding to new prescribers in cardiology and nephrology.
• Afrezza’s pediatric launch is gaining traction: The approval for patients ages six and older targets a concentrated network of pediatric endocrinologists, while a $35 bridge program helps patients access the drug before insurance coverage begins.
• MNKD-201 is advancing toward Phase 2: The 153-patient IPF trial will test two doses against placebo, with data expected in the first half of 2028; MannKind reported encouraging tolerability in Phase 1b.

MannKind NASDAQ: MNKD CFO Chris Prentiss outlined the company’s commercial and development priorities at the H.C. Wainwright Global Investment Conference, emphasizing execution following three major 2026 catalysts: expanded pediatric approval for Afrezza, the launch of FUROSCIX ReadyFlow, and Phase 1b data for MNKD-201 in idiopathic pulmonary fibrosis, or IPF.

Prentiss said the company is now focused on translating those developments into product sales growth while advancing its pipeline. “2026 was a huge investment year for us,” he said. Over the next 12 to 24 months, investors will be looking for sales trends for Afrezza and FUROSCIX, as well as timelines for additional clinical data from MNKD-201, he added.

FUROSCIX ReadyFlow Launch Shows Early Demand

MannKind acquired scPharmaceuticals last year, adding FUROSCIX, a furosemide product initially delivered through an on-body infuser. The company recently received approval for ReadyFlow, an autoinjector formulation of FUROSCIX, which Prentiss said began dispensing to patients during the week of the conference.

According to Prentiss, physicians have submitted cost and coverage requests for ReadyFlow at several times the run rate previously seen for the on-body infuser. He said the activity suggests physicians are aware of the new formulation and interested in using it with patients.

The company is monitoring whether current FUROSCIX prescribers shift to ReadyFlow and identify a broader set of appropriate patients. Prentiss said the on-body infuser was viewed by some physicians as a more complicated device appropriate for a narrower patient population. ReadyFlow could reduce that barrier, he said.

He added that MannKind has seen prescriptions from physicians who had not previously prescribed the on-body infuser, including in cardiology and nephrology. The company expects to make ReadyFlow available later in the integrated delivery network, or IDN, setting.

Prentiss described adoption in hospitals and IDNs as a longer sales-cycle opportunity. While hospitals understand the potential role of ReadyFlow in earlier-discharge protocols and reducing readmissions, each organization has its own operational requirements, he said. MannKind is developing real-world evidence initiatives for ReadyFlow and expects to provide more detail as the year concludes.

Afrezza Pediatric Expansion Targets Concentrated Market

Afrezza, MannKind’s inhaled insulin product, was originally approved in 2014. The company recently received approval for use in patients aged six and older, opening a pediatric indication.

Prentiss said early feedback from the pediatric launch has been encouraging, with enthusiasm that differs from the company’s experience in adults. He attributed part of that opportunity to the concentration of pediatric endocrinologists, noting that approximately 80% of the specialty represents fewer than 1,000 physicians and that most are located at roughly 50 academic centers.

About half of the physicians at those centers participated in MannKind’s clinical trial program, Prentiss said, giving them prior experience with Afrezza. The company is using a key account manager team to engage with those centers.

The company’s near-term focus is on patients’ initial treatment experience, including whether patients reach the appropriate therapeutic dose, refill prescriptions and remain on therapy. Prentiss said positive early patient experiences could support broader use among pediatric prescribers.

Reimbursement conditions in pediatrics have not changed relative to the adult market, according to Prentiss. MannKind launched a bridge program that provides access to Afrezza for $35 while patients work toward insurance coverage. He said patients have generally transitioned to paid prescriptions by their second or third prescription.

MNKD-201 Moves Toward Phase 2 in IPF

MannKind recently released Phase 1b data for MNKD-201, its development-stage treatment for IPF. Prentiss said the company was encouraged by the findings and has updated the planned Phase 2 study design.

The Phase 2 trial will enroll 153 patients and compare 2 milligrams twice daily and 4 milligrams twice daily doses against placebo over 12 weeks, followed by an open-label extension. MannKind expects to generate data by the first half of 2028.

Prentiss said the Phase 1b results showed no gastrointestinal distress and no significant cough concerns, with more than 90% of participants reporting either no cough or mild cough. In Phase 2, the company wants to see a difference between treated patients and placebo at week 12 and determine the most appropriate dose for a potential Phase 3 program.

He said MannKind views MNKD-201 as a potentially more tolerable version of nintedanib, which he described as a longstanding backbone therapy in IPF. The company believes the product could potentially serve as a background therapy in combination-treatment approaches.

Company Focuses on Self-Sustaining Growth

Prentiss said MannKind’s strategy is to build significant revenue from Afrezza and FUROSCIX, advance MNKD-201 and remain selective on business-development opportunities. The company aims to become more self-sustaining and less dependent on royalty income, while using royalties to support profitability, debt reduction, its scPharmaceuticals acquisition and potential future business development.

For 2027, Prentiss said the main measures of progress will be net sales trends for Afrezza and FUROSCIX and development timelines across IPF programs, including MNKD-201. While he declined to forecast how quickly the pediatric Afrezza opportunity can be judged commercially, he said early metrics remain small but are moving in a favorable direction.

About MannKind (NASDAQ:MNKD)

MannKind Corporation, a biopharmaceutical company, focuses on the development and commercialization of inhaled therapeutic products for endocrine and orphan lung diseases in the United States. It offers Afrezza, an inhaled insulin used to improve glycemic control in adults with diabetes, and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults. The company's product pipeline also includes Tyvaso DPI (Treprostinil), an inhalation powder for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease; MNKD-101, a nebulized formulation of clofazimine, for the treatment of severe chronic and recurrent pulmonary infections, including nontuberculous mycobacterial lung disease; MNKD-201, a dry-powder formulation of nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF).

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