MannKind Corporation (MNKD) Earnings

Management highlights

### 2026 Core Catalyst Milestones Achieved - All three 2026 strategic catalysts were delivered: Afrezza pediatric approval, Furosix ReadyFlow auto-injector approval, and positive Phase 1b results for Netetnib DPI in idiopathic pulmonary fibrosis (IPF) patients. ### Afrezza (Inhaled Insulin) Pediatric Launch - First alternative mealtime insulin for pediatrics in over 100 years, addressing unmet need with ultra-rapid onset and offset kinetics unmatched by injectable insulin or pumps. Access is set at $35 per month for patients. - All 20 priority top pediatric treatment centers have written at least one prescription, and 1 in 3 of the top 100 pediatric rapid-acting insulin prescribers have already prescribed the product, with strong early demand driven by caregiver, influencer, and KOL advocacy that was not present for the original adult launch. - 450 new prescribers have joined since launch, 200 of which are new pediatric prescribers; 200 of 450 new prescribers are for pediatrics, with 250 new adult prescribers also joining driven by increased confidence from pediatric approval. - Product roadmap: 2-unit cartridge launch and Bluetooth-connected Inhale IQ device (integrated with CGM) expected in 2027; high-concentration formulations expected in 2028 to reduce powder load and cough side effects for higher doses in type 2 diabetes. ### Furosix ReadyFlow Auto-Injector - ReadyFlow is the only IV-equivalent diuretic delivered via auto-injector, indicated for early intervention of fluid overload in community settings and post-hospital discharge to reduce ER visits and 30-day readmissions. - Q2 2026 Furosix revenue grew 43% quarter-over-quarter, with 67% quarter-over-quarter growth in the nephrology segment following Salesforce expansion that split nephrology and cardiology sales teams. Marketing investments will be increased in H2 2026 to support the launch. - Launch is expected by the end of August 2026, with immediate field activation and conference promotion planned for fall 2026. ### Netetnib DPI IPF Development Program - Positive Phase 1b results in IPF patients demonstrated a clean safety profile: zero serious adverse events, zero treatment discontinuations, zero bronchospasms. While 39% of patients experienced cough after first dose, no dose reductions or discontinuations were required, and cough does not worsen over time. - The program delivers 6-8x higher Cmax (peak lung concentration, which is the key driver of IPF efficacy) than published nebulized treatment data, with higher lung tissue levels than oral therapies that cannot reach sufficient lung concentrations. - Phase 2 study is underway, with the first patient already dosed, and site activation continuing through 2026. ### Financial Update - Pro forma cash position at quarter end was $161 million following a $50 million pipe financing, sufficient to cover the $45 million contingent value right (CVR) payout for ReadyFlow approval, support both launches, and accelerate the IPF development program. - GAAP net loss for Q2 was $19 million, non-GAAP net loss was $2.7 million, with increased losses driven by planned investments in launches and development following the SC Pharma acquisition. 2026 is a deliberate investment year focused on execution post-approval.

Guidance

- Overall revenue guidance for full-year 2026 Furosix is maintained at $110-$120 million, implying ~$75 million in revenue in H2 2026, which aligns with historical seasonal trends where ~two-thirds of annual Furosix volume is realized in the second half. - Management expects Q2 2026 will be the highest quarter of annual manufacturing-related collaboration revenue, with full-year 2026 manufacturing-related revenue expected to be in line with 2025 levels. - Furosix gross margin is expected to increase by ~70% after transitioning from the on-body infuser to ReadyFlow, with the margin difference further exacerbated by incoming tariffs on imported on-body infuser product. - A 2-unit Afrezza cartridge, prioritized for pediatric and newly diagnosed patients, is expected to launch in 2027; high-concentration Afrezza cartridges are expected 12-18 months from Q2 2026. - Netetnib DPI Phase 2 protocol has been submitted to the FDA, with feedback expected in fall 2026; the working assumption is that one positive Phase 2/3 trial will be sufficient for approval, pending FDA confirmation.

Segment performance

Total Q2 2026 revenue was $109.4 million, a 43% year-over-year increase, with first half 2026 revenue reaching $199.5 million (29% year-over-year growth). Marketed commercial products drove 27% quarter-over-quarter growth, while royalty revenue declined 1% quarter-over-quarter, and marketed products now represent the majority of total revenue, reflecting successful diversification. Afrezza generated $17.0 million in net sales, with limited pediatric launch activity included (approval received May 29, 2026; separate adult/pediatric reporting will be provided post-launch phase). Furosemide (406/FreeO6) generated $22.2 million in net sales, a 43% quarter-over-quarter increase, with a 49% increase in units sold partially offset by higher gross-to-net adjustments of 29%. Royalty revenue from United Therapeutics was $32.4 million, a 4% year-over-year increase. Collaboration and services revenue was $35.0 million, a 53% year-over-year increase, contributing 32% of total Q2 revenue. Overall, promoted commercial products now account for a larger share of revenue than stable UT-related revenue streams.

Risks & headwinds

- Patient affordability and Medicare donut hole dynamics create headwinds for Furosix adoption in the first half of the year, with co-payment assistance foundations significantly reduced in 2026 after generic entry for other heart failure drugs, limiting patient access early in the calendar year. - The regulatory path for Netetnib DPI and IPF/other interstitial lung disease indications remains uncertain: it is still unclear whether one trial will be sufficient, or if separate trials will be required for additional indications, which could increase development time and cost. - Most early Afrezza pediatric prescriptions are currently paid via cash, as the company works through prior authorization and payer coverage; conversion to standard insured channels is expected but not guaranteed, and full conversion may take until the end of 2026. - Furosix ReadyFlow launch timing is delayed three weeks after FDA approval due to required third-party supply chain processing for labeling and packaging, which introduces minor near-term timing risk to launch revenue. - Inventory conversion timing between on-body infuser and ReadyFlow introduces quarterly revenue volatility for Furosix in H2 2026.

Analyst Q&A

• Q: What proportion of early Afrezza pediatric prescriptions are cash-pay, and when do you expect conversion to standard insured channels? /

  A: Currently, more than half of early prescriptions are cash-pay, as the company works through payer prior authorization and appeals. Pediatric approval rates are consistent with historical adult approval rates. The current cash-pay program runs through the end of 2026, and management expects most patients will convert to standard coverage by that time as payer contracts are finalized.

• Q: What is the regulatory path forward for the Netetnib IPF program, and will you pursue other interstitial lung disease indications like PPF? /

  A: The Phase 2 protocol has been submitted to the FDA, with feedback expected in fall 2026. The working assumption is one trial will be sufficient for IPF approval, consistent with recent FDA signaling for similar programs. Management is evaluating PPF and other ILD indications, but will first establish dosing in Phase 2 before deciding whether to pursue additional indications in parallel.

• Q: What is the current pace of pediatric Afrezza scripts, and how will the adult/pediatric mix trend long-term? /

  A: After an initial bolus of waiting patients in the first two weeks, the company has seen consistent steady growth despite the July 4th holiday and summer vacation period. Top prescribers are already writing 20-30 scripts each. Adult Afrezza hit a nadir in Q2 as resources were shifted to pediatrics, but new patient growth grew 30% month-over-month in July. Long-term, pediatrics will drive most growth momentum, but adult will also grow alongside pediatric demand, with new adult prescribers already entering following the pediatric approval.

• Q: What is the shortest possible approval path for Netetnib DPI, and does the trial need to show benefit on top of existing therapy? /

  A: Management did not provide specific timeline guidance, but confirmed the working assumption of a single Phase 2/3 trial to approval, pending FDA confirmation. The breakdown of expected patient sources for peak 20-30% pediatric Afrezza market share is 50% from existing multiple daily injection patients, 20-30% from pump patients or as add-on to pumps, and 15-20% from insulin-naive patients, matching early launch data.

• Q: Why haven't two-thirds of the top 100 pediatric insulin prescribers written Afrezza yet, and why is ReadyFlow launching three weeks after approval? /

  A: The remaining two-thirds of top prescribers are mostly large academic centers with summer vacation schedules, and in-services are already scheduled for August-September, with many sites requesting earlier in-services due to patient demand. There are no major objections to adoption, providers are just in the process of learning the product. The ReadyFlow delay is due to required third-party supply chain processing for labeling and packaging for U.S.-manufactured product, with all work on track for end-of-August launch.