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MannKind Sees Q4 Profit as Third-Quarter Revenue Rises 24%
MannKind posted $101.9 million of third-quarter revenue, up 24%, and expects a fourth-quarter profit as ReadyFlow and pediatric Afrezza advance despite a $23.2 million net loss.
By Amara Osei
What does the fourth-quarter profit target require?
On Nov. 5, CFO Chris Prentiss said MannKind generated $101.9 million of third-quarter revenue, up 24% from $82.1 million, but posted a $23.2 million net loss versus $8 million of net income in 2025. Management expects a return to GAAP and non-GAAP profitability in the fourth quarter.
Q4 profitability is the next test.
The company also expects annual profitability in 2027. “Profitability next year would not necessarily begin in the first quarter,” Prentiss said. MannKind plans to keep investment in expenses relatively stable while prioritizing revenue growth.
Nine-month 2026 revenue climbed 27% to $301.4 million, but the net loss reached $58.9 million, versus $21.8 million of net income a year earlier. Prentiss said a significant portion of the GAAP loss was noncash and tied to the scPharma acquisition.
MannKind also closed a $50 million private placement, funding a $45 million contingent value right payment triggered by ReadyFlow approval.
Takeaway: Q4 profitability rests on revenue growth, while noncash acquisition costs weigh on nine-month GAAP earnings.
How is ReadyFlow changing FUROSCIX?
FUROSCIX generated $22.4 million in third-quarter net revenue. MannKind began shipping the ReadyFlow version in mid-September, and about 75% of FUROSCIX shipments had shifted to ReadyFlow by late October, CEO Mike Castagna said.
Prentiss estimated the transition shaved about $3 million from third-quarter revenue as patients and prescribers moved toward ReadyFlow before it was available for dispensing and channel launch inventory remained limited. ReadyFlow carries a meaningfully lower cost of goods than the older On-body Infusor.
Prescriptions rose about 56% in the six weeks after launch versus the preceding six weeks, with much of the increase coming from new patients and prescribers, including physicians in nephrology and cardiology.
Management expects fourth-quarter FUROSCIX revenue near $38 million, roughly matching the first half of 2026. Management also expected longer-dated inventory the following week, potentially easing concerns about short-dated supply. MannKind plans a larger sales force and stronger promotion into 2027, while the Medicare deductible reset remains an out-of-pocket barrier early in the year.
Takeaway: ReadyFlow conversion supports the fourth-quarter target, while supply and patient affordability still frame 2027.
Can pediatric Afrezza sustain growth?
Afrezza third-quarter net revenue increased about 5% year over year to $19.3 million, while total prescriptions rose roughly 17% from the second quarter. Pediatric patients now account for about one in four Afrezza prescriptions.
Since launch, more than 2,000 pediatric patients have received treatment, about 600 pediatric prescribers have prescribed Afrezza, and all 60 priority pediatric institutions have prescribed it, Castagna said.
Prescription growth outpaced revenue because a pediatric access program runs through the end of 2026. More than half of pediatric prescriptions already have insurance reimbursement; converting the remainder to paid coverage is a 2027 priority. Castagna said MannKind does not intend to continue its $35 cash-pay program next year.
The adult Afrezza business has underperformed this year, Castagna said, citing field-team turnover, competition from new insulin pumps and reduced promotion as resources moved to the pediatric launch and FUROSCIX. MannKind now plans to refocus on adults without reducing support for pediatric adoption.
Takeaway: Pediatric Afrezza is expanding faster than sales, and 2027 depends on paid coverage and an adult recovery.
How are royalties and collaboration sales moving?
Royalty revenue increased 12% year over year to $37.5 million, driven by Tyvaso DPI, which MannKind manufactures for United Therapeutics. Collaboration and services revenue fell to $19.4 million from $26.5 million, a decline Prentiss attributed to delivery timing.
Full-year collaboration and services revenue should remain consistent with 2025, he said. Delivery timing remains the main swing factor.
Takeaway: Royalty growth offsets collaboration volatility, while management expects the collaboration line to finish near its 2025 level.
What milestones sit in the pipeline?
MannKind expects a first-half 2028 data readout from INFLO-2, a global phase 2 study of inhaled nintedanib in patients with idiopathic pulmonary fibrosis. Castagna said the company reduced the planned study size to about 150 patients from 220 and is activating sites under an updated protocol.
An upcoming FDA meeting could determine whether U.S. sites join, potentially accelerating the study. “There will be no interim analysis,” Castagna said. The trial will assess safety and tolerability alongside early lung-function measures.
MannKind also expects $15 million in ralinepag DPI milestones from United Therapeutics in 2027. The companies have not disclosed the specific triggers, and MannKind would receive a 10% royalty on the product.
Takeaway: The nearer financial marker is $15 million of 2027 ralinepag milestones, while INFLO-2 adds a 2028 readout.
What products sit behind the revenue?
MannKind develops and commercializes inhaled treatments for endocrine and orphan lung diseases in the United States. Its portfolio includes:
- Afrezza is inhaled insulin for glycemic control in adults with diabetes; V-Go is a wearable device that provides continuous subcutaneous insulin delivery to adults.
- Tyvaso DPI (treprostinil) is an inhalation powder for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
- MNKD-101 is a nebulized clofazimine formulation for severe chronic and recurrent pulmonary infections, including nontuberculous mycobacterial lung disease.
- MNKD-201 is a dry-powder nintedanib formulation for idiopathic pulmonary fibrosis.
Takeaway: The portfolio spans inhaled insulin, wearable insulin delivery and partnered or developmental inhaled lung treatments.
Audit trail
- Third-quarter revenue rose 24% to $101.9 million; the net loss was $23.2 million.
- Management expects GAAP and non-GAAP fourth-quarter profitability and annual profitability in 2027.
- FUROSCIX generated $22.4 million; about 75% of shipments had shifted to ReadyFlow by late October.
- Afrezza revenue rose about 5% to $19.3 million; prescriptions rose about 17% from the second quarter.
- INFLO-2 data are expected in first-half 2028, with the study reduced to about 150 patients from 220.
via dailypolitical.com (Source)
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