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    MNKD
    Earnings call· Jun 2026(Q2 FY26)

    MANNKIND Q2 FY26 earnings call MNKD

    Aug 5, 2026 Source

    Executive summary

    MannKind Q2 FY26 — Strong Afrezza Pediatric Launch and Furoscix ReadyFlow Approval

    MannKind delivered on its three key catalysts for 2026, including the successful launch of Afrezza in pediatrics and the FDA approval of Furoscix ReadyFlow, which is expected to drive significant growth in marketed products. The company also reported positive Phase Ib data for nintedanib DPI, validating its pipeline. While investments in launches and development led to a net loss this quarter, management remains focused on disciplined execution and leveraging these new opportunities for future growth.

    Highlights

    5
    • Total revenue increased 43% year-over-year to $109.4 million.

    • Marketed products revenue grew 111% year-over-year (excluding collaboration service revenue).

    • Furoscix net sales increased 43% from Q1 FY26 to $22.2 million, driven by a 49% increase in units sold.

    • Afrezza pediatric launch saw 1 in 3 of the top 100 pediatric rapid-acting writers prescribe, with 20 priority accounts writing at least one prescription.

    • Nintedanib DPI Phase Ib study demonstrated positive safety and tolerability in IPF patients with no serious adverse events or discontinuations.

    Concerns

    5
    • Royalties declined 1% from Q1 FY26 to Q2 FY26.

    • Furoscix gross-to-net adjustments increased to 29% for the current quarter.

    • GAAP net loss of $19 million in Q2 FY26 compared to GAAP net income in prior year.

    • Non-GAAP net loss of $2.7 million in Q2 FY26 compared to non-GAAP net income in prior year.

    • Furoscix guidance implies significant second-half ramp, with inventory shifts between autoinjector and on-body infusor potentially creating noise.

    Guidance & targets

    2
    CategoryTargetConfidence
    Manufacturing-related revenues
    In line with prior year
    medium materiality
    Medium
    Furoscix annual revenue
    $110 million to $120 million
    high materiality
    High

    Segment performance

    6
    SegmentRevenueYoYQoQMargin
    Total Revenue
    Second quarter revenue was $109.4 million, up 43% year-over-year and first half revenue reached $199.5 million, up 29% over the first half revenue of 2025.
    $109.4 million43%
    Marketed Products (Afrezza & Furoscix)
    marketed products grew 27% quarter-over-quarter, where royalties declined 1% from Q1 to Q2. When you take out our collaboration service revenue, you can really see an underlying picture what's driving our growth quarter-to-quarter. ... When you take out the collaboration service revenue, we grew 111% on marketed products year-over-year.
    111%27%
    Afrezza
    Afrezza generated $17 million in net sales. ... we pulled back resources this year on the adults. So obviously, we see a little softness in Afrezza year-over-year. ... the adult business, it does look like it hit a nadir here in Q2, Q3, and that momentum in July did start to build back up with new patients growing almost 30% over the month of June.
    New prescribers (since pediatric launch): 450New pediatric prescribers: 200New adult prescribers: 250Total writers (since June 1 launch): 1,800Top 100 pediatric rapid-acting writers prescribed: 1 in 3Priority accounts prescribed: 20 out of 20New-to-brand therapy growth (June): 50% jumpCustomers writing 3+ scripts: >30%
    $17 million
    Furoscix
    Furoscix generated $22.2 million in net sales, an increase of 43% from the first quarter. This was driven by a 49% increase in units sold, with the offset due to an increase in gross to net adjustments, which were 29% for the current quarter. ... We saw 36% growth in Q2 over Q1. ... 67% growth in nephrology in Q2 over Q1 and a record number of prescribers.
    Units sold growth: 49%Gross to net adjustments: 29%IDN engagement growth (Q2 over Q1): 36%Nephrology growth (Q2 over Q1): 67%
    $22.2 million43%
    Royalties (United Therapeutics)
    Royalty revenue increased 4% over the second quarter of 2025 to $32.4 million, while collaboration and services revenue increased 53% to $35 million. ... royalties declined 1% from Q1 to Q2.
    $32.4 million4%-1%
    Collaboration and Services Revenue (United Therapeutics)
    Collaboration and services revenue increased 53% to $35 million. The increase in collaboration revenue was primarily attributable to a higher volume of products sold through to United Therapeutics and to a lesser extent, price. In addition, we recognized $4.9 million of revenue associated with ralinepag DPI development milestones during the quarter.
    $35 million53%

    Operational metrics

    18
    First half revenue
    $199.5 millionup 29% over H1 FY25
    H1 FY26

    first half revenue reached $199.5 million, up 29% over the first half revenue of 2025.

    GAAP Net Loss
    $19 millioncompared with GAAP net income of $700,000 in Q2 FY25
    Q2 FY26

    For the second quarter of 2026, we reported a GAAP net loss of $19 million compared with GAAP net income of $700,000 in the prior year quarter.

    Non-GAAP Net Loss
    $2.7 millioncompared with non-GAAP net income of $13.9 million in Q2 FY25
    Q2 FY26

    Our non-GAAP net loss was $2.7 million compared with non-GAAP net income of $13.9 million in the second quarter of 2025.

    Amortization of acquired intangible assets (ReadyFlow autoinjector)
    $2.2 million
    Quarterly

    Now that the autoinjector has been approved, we will begin to amortize this intangible asset in the third quarter and on a full quarter basis will be approximately $2.2 million.

    Contingent Value Right (CVR) payment
    $45 million
    Q3 FY26

    We will pay out the $45 million CVR in Q3 and the balance of expense, approximately $16 million, will be recorded in the quarter.

    Pro forma cash position
    $161 million
    Q2 FY26 end

    In conjunction with the autoinjector approval, we announced a $50 million pipe financing, providing us pro forma cash position at quarter end of $161 million...

    R&D expense
    $18 millioncompared with $13.7 million in Q2 FY25
    Q2 FY26

    R&D expense was $18 million compared with $13.7 million in the prior year quarter.

    SG&A expense
    $58.3 millioncompared with $31.6 million in Q2 FY25
    Q2 FY26

    SG&A expense was $58.3 million compared with $31.6 million in the prior year quarter.

    Nintedanib DPI Phase Ib study, females
    37%
    Phase Ib study

    When you look at the baseline characteristics, the age was 73, the females were 37% and the pulmonary function at baseline is consistent with what you'd expect in this population with an FEV1 of almost 2 liters.

    Nintedanib DPI Phase Ib study, cough incidence
    39%
    Phase Ib study

    cough was about 39% in this trial. But there was no other single adverse event that really showed any concerns as we look at safety and tolerability in the placebo group or the active group. ... 60% of patients had no cough post inhalation and about 30% of patients had a mild cough.

    Nintedanib DPI Phase Ib study, patients with mild cough
    90%
    Phase Ib study

    So when we think about 90% of patients had very mild cough and none of these were severe.

    Nintedanib DPI Phase Ib study, doses administered
    Over 450
    7 days

    There were over 450 doses administered over 7 days in patients with IPF and not one patient had the dose reduced due to the powder load or the cough from the powder itself.

    Furoscix gross margin uplift (ReadyFlow vs OBI)
    70%
    Future

    the margin increases by about 70% when we think about the transition from OBI to the ReadyFlow.

    Afrezza new prescribers (since pediatric launch)
    450
    Since pediatric launch

    we had roughly about 450 docs come in since launch that are new prescribers. And I'd say -- and this is just one part of the data, not all the data but on the conservative side. And of those, about 200 were peds and about 250 were adults.

    Afrezza total writers (since June 1 launch)
    1,800
    Since June 1 launch

    And we had about 1,800 writers of Afrezza since the June 1 launch.

    Afrezza new-to-brand therapy growth (June)
    50%jump
    June

    we did see almost a 50% jump in new-to-brand therapy just in June alone

    Afrezza customers writing 3+ scripts
    Over 30%
    Current

    over 30% of our customers have written three or more scripts from what we can see.

    Afrezza adult new patients growth (July)
    almost 30%over the month of June
    July

    new patients growing almost 30% over the month of June.

    Industry KPIs

    6
    MetricValueDetails
    Launch access metrics$35USD
    Pipeline read out calendarPhase Ib study showed positive safety and tolerability
    Regulatory approvals filingsApproved
    Prescription volume new starts450 new prescribersdocs
    Clinical trial efficacy safety dataNo serious adverse events, no GI burden, no discontinuations due to safety, no difference in spirometry parameters between placebo and nintedanib DPI
    Collaboration milestone royalty revenue$4.9 millionUSD

    Product announcements

    3
    ProductTypeDetails
    Afrezza 2-unit cartridgeroadmap
    INHALE IQ (Afrezza)roadmap
    High concentration formulations of Afrezzaroadmap

    Deals & partnerships

    1
    scPharmaAcquisition of Furoscix on-body infusor

    Acquisition of Furoscix on-body infusor, leading to increased personnel and cost structure.

    Risks & headwinds

    6
    Royalties declineQ2 FY26

    declined 1% from Q1 to Q2

    Mitigation: Management states royalties 'remain a durable revenue stream for years to come' and provide a 'strong base business.'

    Furoscix gross-to-net adjustmentsQ2 FY26

    29% for the current quarter

    Mitigation: Not explicitly stated, but implies impact on net sales despite unit growth.

    Investment year leading to net lossQ2 FY26

    GAAP net loss of $19 million, non-GAAP net loss of $2.7 million in Q2 FY26.

    Mitigation: Described as 'planned investments' to support Furoscix, pediatric Afrezza, and MannKind-201 development. Focus has shifted to 'disciplined execution' and 'appropriately managing our cost structure.'

    Furoscix H2 revenue ramp and inventory shiftsH2 FY26

    Implies roughly $75 million+ in H2 FY26 to meet $110-120 million FY guidance, doubling H1.

    Mitigation: Management cites historical trends (2/3 units in H2) due to patient affordability and co-pay dynamics. Acknowledges inventory shifts between autoinjector and on-body infusor could create 'noise' but expects to achieve demand based on history.

    Afrezza adult segment softnessQ2 FY26

    a little softness in Afrezza year-over-year

    Mitigation: Attributed to pulling back resources; adult business 'hit a nadir' in Q2/Q3, with July new patients growing 30% over June, expecting growth with peds.

    Furoscix on-body infusor tariffsFuture periods

    impacted by tariffs

    Mitigation: Transition to ReadyFlow (which has higher margin) will exacerbate the difference and help mitigate.

    What to watch in Q3 FY26

    4

    Afrezza pediatric script trends and refills

    Next quarter (Q3 FY26)
    CurrentConsistent, steady referral pattern, momentum building, hitting new peaks every week.
    TargetContinued acceleration in script growth and clear refill patterns.

    Why it matters

    Demonstrates sustained uptake and patient adherence, crucial for the long-term success of the pediatric launch.

    The last 2 weeks, you're starting to see that build up with potential refills as well as momentum. So I expect continued momentum as the quarter and the months progress ahead.

    Q&A highlights

    8

    What proportion of pediatric Afrezza scripts are coming through the cash program, and when are these patients expected to convert to standard channels?

    A good portion of dispensed scripts are fully paid, with about half going through as cash. It's too early to tell the conversion rate, but the company is pursuing prior authorizations and appeals. The cash program will run through the end of 2026, with hopes of working through payer coverage by then. Pediatric approval rates are consistent with adult rates.

    more than half grown through is cash, but that we expect many of those to convert to paid.

    asked by Ben Burnett · answered by Michael Castagna

    2 min read6 chapters

    Detailed Narrative

    01

    Afrezza Pediatric Launch Strategy

    MannKind's strategy for Afrezza in pediatrics differs significantly from its adult launch, focusing on a concentrated prescriber base of approximately 1,000 institutional prescribers, a connected patient-centric community, a stronger clinical foundation with KOL support, and efforts to remove access friction. Early metrics show 1 in 3 of the top 100 pediatric rapid-acting writers have prescribed, and all 20 priority accounts have written at least one prescription. The company is seeing strong media coverage and engagement from caregivers and advocacy groups.

    02

    Furoscix Growth Opportunities & ReadyFlow Impact

    The company is advancing Furoscix growth through increased IDN engagement, separating sales forces for nephrology and cardiology, and preparing for the ReadyFlow launch with increased marketing spend. The ReadyFlow autoinjector, approved by the FDA, is the only IV-equivalent diuretic delivered via an autoinjector, offering rapid treatment delivery and potential to prevent ER visits and reduce hospital readmissions. It will be available to key institutions and community prescribers within three weeks.

    03

    Nintedanib DPI Clinical Progress

    The Phase Ib study for nintedanib DPI in IPF patients demonstrated positive safety and tolerability, with no serious adverse events, GI burden, or discontinuations due to safety. Cough was observed in 39% of patients, mostly mild and transient📎, with no dose reductions. The Phase II study is underway, with the first patient dosed. Preclinical work suggests significantly higher lung concentrations than plasma by direct lung targeting, and Cmax is known to drive efficacy in pulmonary fibrosis.

    04

    Revenue Diversification

    MannKind's diversification strategy is showing success, with marketed products (Afrezza and Furoscix) now demonstrating faster growth and a higher percentage of total revenue compared to royalties. Excluding collaboration service revenue, marketed products grew 111% year-over-year. Royalties remain a durable revenue stream, providing a strong base for future launches.

    05

    Afrezza Future Development

    The roadmap for Afrezza includes additional product development, digital advancements, and external innovation. Key upcoming developments include a 2-unit cartridge and INHALE IQ (a Bluetooth-connected device integrated with CGM) expected in 2027, and high-concentration formulations of Afrezza by 2028 to enable higher doses, lower powder loads, and increased cost-effectiveness, particularly for type 2 diabetes patients.

    06

    Financial Performance and Investment

    Q2 FY26 revenue was $109.4 million, up 43% year-over-year. The company reported a GAAP net loss of $19 million and a non-GAAP net loss of $2.7 million, reflecting planned investments in Furoscix ReadyFlow, pediatric Afrezza launch, and the MannKind-201 development program. A $45 million CVR related to the autoinjector approval will be paid in Q3, with a $50 million PIPE financing providing a pro forma cash position of $161 million.

    AI-generated summary of the company’s earnings call. Not investment advice.