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Earnings documents stored for MNKD.
Investor releaseQuarter not tagged2026-08-06MannKind Corp (MNKD) (Q2 2026) Earnings Call Highlights: Record Revenue and Major Catalysts ...
GuruFocus.com
MannKind Corp (MNKD) (Q2 2026) Earnings Call Highlights: Record Revenue and Major Catalysts ...
This article first appeared on GuruFocus. Second Quarter Revenue: $109.4 million, up 43% year-over-year. First Half Revenue: $199.5 million, up 29% over the first half of 2025. Afrezza Net Sales: $17 million in Q2 2026. Furosix Net Sales: $22.2 million, up 43% from Q1 2026. Furosix Units Sold: Increased 49% quarter-over-quarter. Royalty Revenue: $32.4 million, up 4% year-over-year. Collaboration and Services Revenue: $35 million, up 53% year-over-year. GAAP Net Loss: $19 million in Q2 2026, compared with GAAP net income of $700,000 in the prior year quarter. Non-GAAP Net Loss: $2.7 million, compared with non-GAAP net income of $13.9 million in Q2 2025. R&D Expense: $18 million, compared with $13.7 million in the prior year quarter. SG&A Expense: $58.3 million, compared with $31.6 million in the prior year quarter. Pro Forma Cash Position: $161 million at quarter end. Warning! GuruFocus has detected 8 Warning Signs with MNKD. Is MNKD fairly valued? Test your thesis with our free DCF calculator. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. MannKind Corp (NASDAQ:MNKD) achieved all three major 2026 catalysts: Afrezza pediatric approval, Furo6 ReadyFlow approval, and positive Phase 1b data for nintedanib DPI in IPF patients. Afrezza pediatric launch shows strong early momentum, with all 20 priority accounts writing prescriptions and one in three of the top 100 pediatric rapid-acting insulin prescribers already prescribing. Furo6 revenue grew 43% quarter-over-quarter, driven by a 49% increase in units sold, with nephrology sales up 67%. Marketed products revenue grew 111% year-over-year, now exceeding royalty revenue, demonstrating successful diversification. The nintedanib DPI Phase 1b study showed a clean safety profile with zero serious adverse events, zero bronchospasms, and zero discontinuations, supporting chronic use. Furo6 ReadyFlow, the only IV-equivalent diuretic auto-injector, is expected to launch within three weeks, with a 70% gross margin improvement over the on-body infuser. The company raised $50 million in a pipe financing, providing pro forma cash of $161 million to support launches and development. MannKind Corp (NASDAQ:MNKD) reported a GAAP net loss of $19 million in Q2 2026, compared to net income of $0.7 million in the prior year quarter. The company expects…Read full documentShow less
This article first appeared on GuruFocus. Second Quarter Revenue: $109.4 million, up 43% year-over-year. First Half Revenue: $199.5 million, up 29% over the first half of 2025. Afrezza Net Sales: $17 million in Q2 2026. Furosix Net Sales: $22.2 million, up 43% from Q1 2026. Furosix Units Sold: Increased 49% quarter-over-quarter. Royalty Revenue: $32.4 million, up 4% year-over-year. Collaboration and Services Revenue: $35 million, up 53% year-over-year. GAAP Net Loss: $19 million in Q2 2026, compared with GAAP net income of $700,000 in the prior year quarter. Non-GAAP Net Loss: $2.7 million, compared with non-GAAP net income of $13.9 million in Q2 2025. R&D Expense: $18 million, compared with $13.7 million in the prior year quarter. SG&A Expense: $58.3 million, compared with $31.6 million in the prior year quarter. Pro Forma Cash Position: $161 million at quarter end. Warning! GuruFocus has detected 8 Warning Signs with MNKD. Is MNKD fairly valued? Test your thesis with our free DCF calculator. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. MannKind Corp (NASDAQ:MNKD) achieved all three major 2026 catalysts: Afrezza pediatric approval, Furo6 ReadyFlow approval, and positive Phase 1b data for nintedanib DPI in IPF patients. Afrezza pediatric launch shows strong early momentum, with all 20 priority accounts writing prescriptions and one in three of the top 100 pediatric rapid-acting insulin prescribers already prescribing. Furo6 revenue grew 43% quarter-over-quarter, driven by a 49% increase in units sold, with nephrology sales up 67%. Marketed products revenue grew 111% year-over-year, now exceeding royalty revenue, demonstrating successful diversification. The nintedanib DPI Phase 1b study showed a clean safety profile with zero serious adverse events, zero bronchospasms, and zero discontinuations, supporting chronic use. Furo6 ReadyFlow, the only IV-equivalent diuretic auto-injector, is expected to launch within three weeks, with a 70% gross margin improvement over the on-body infuser. The company raised $50 million in a pipe financing, providing pro forma cash of $161 million to support launches and development. MannKind Corp (NASDAQ:MNKD) reported a GAAP net loss of $19 million in Q2 2026, compared to net income of $0.7 million in the prior year quarter. The company expects Q2 to be the highest quarter for manufacturing-related revenues, with annual revenues in line with the prior year, indicating potential revenue decline in the second half. Afrezza adult sales saw softness due to resource reallocation to pediatrics, with a year-over-year decline. Furo6 gross-to-net adjustments increased to 29% in Q2, offsetting some revenue growth. The company will incur a $45 million CVR payment in Q3, impacting cash flow. The nintedanib DPI Phase 1b study reported a 39% cough rate, though mostly mild and transient. Furo6 guidance implies a significant second-half revenue ramp, which may be challenging given patient affordability issues and inventory transitions. Q: What proportion of Afrezza scripts are coming through the cash program, and do you expect these patients to convert to more standard channels?A: Michael Castagna, CEO: More than half of the scripts are going through as cash, with the other half as fully paid. It's too early to tell how quickly conversion will happen, but we are pursuing prior authorizations and appeals. The $35 cash program will run through the end of 2026, and we hope to work through most payers by then. Pediatric approval rates are consistent with adult approval rates, which is a positive indicator. Q: Can you walk us through the regulatory path forward for the IPF program (MannKind 201), and is PPF something you're looking into?A: Michael Castagna, CEO: We met with the FDA last year and have submitted the Phase 2 protocol for review, with feedback expected in the fall. The FDA likely wants to see the effect size from Phase 2 before determining if one trial is sufficient for approval. We are exploring IPF, PPF, and ILD indications. The working assumption is at least one trial for IPF, with additional data potentially needed for other populations, but the effect size will drive those discussions. Q: Can you help us understand the pace of script trends in the pediatric setting, and how do you expect the mix of adult and pediatric scripts to trend?A: Michael Castagna, CEO: We saw an initial bolus of patients, followed by a steady referral pattern. The last two weeks have shown building momentum, with our highest week occurring recently. We are adding roughly 1,000 new pediatric targets to our 70 reps. About 450 new prescribers have come in since launch (200 peds, 250 adults). We're seeing about 60-70% of patients coming from MDI, with a third using it intermittently. The adult business hit a nadir in Q2/Q3 but is building back, with new patients growing almost 30% in July. Q: With the previously quoted 23-37% peak share range for Afrezza, how much assumes conversion of pumps/pods versus MDI patients? And what is the shortest credible route to approval for the 201 program?A: Michael Castagna, CEO: We expect roughly half of patients to come from MDI, 20-30% from pumps (either switching or adding on), and 15-20% insulin-naive. The two-unit cartridge will help in the naive setting. For 201, my initial goal was a biosimilar-like pathway with non-inferiority, but we need Phase 2 data to show effect size. The FDA likely prefers an add-on design with placebo. The success of JASCADE and Tyvaso nebulizer will help enrollment in a Phase 3 add-on trial. Q: Any color on refills or prescribers writing repeat prescriptions for Afrezza, and is the dosing data resonating with pediatric prescribers?A: Michael Castagna, CEO: We are seeing refills in month two, which is a good sign. Over 30% of customers have written three or more scripts. The learning curve is different from adultscost is not perceived as a barrier (we charge $35), and the label change on dosing brings confidence. Some TOP20 institutions took seven weeks to embed lung function tests, but that's now done. The dosing change is helping patients start and should result in fewer dropouts. Q: Regarding the pediatric launch, one in three of the TOP100 pediatric insulin writers have prescribedwhat about the other two-thirds? And what needs to happen in the three weeks before the ReadyFlow launch?A: Michael Castagna, CEO: The other two-thirds are likely due to summer vacations and scheduling in-services. There are no major objectionsthe audience is engaged and asking the right questions. On ReadyFlow, the supply chain is outsourced, and we need time for labeling, packaging, and fitting into the queue. We're training reps the week of August 10th, and inventory should be available by the end of that week or the following Monday. Q: When will the additional doses for Afrezza be available, and what will the mix be? How should we think about product gross margin with the ReadyFlow transition?A: Michael Castagna, CEO: High doses will take another 12-18 months. The two-unit cartridge is already on stability, and we hope to get it to market in 2027. It will help with titration and the pediatric market. Chris Prentice, CFO: The Furosix margin increases by about 70% with the transition from OBI to ReadyFlow. For 2027, a large majority of sales will be ReadyFlow, which will significantly help margins. The on-body will also be impacted by tariffs, exacerbating the margin difference. Q: With Furosix first-half revenue of ~$38 million, achieving the $110-120 million guidance implies roughly doubling in the second half. Can you walk us through the cadence and key assumptions?A: Michael Castagna, CEO: In 2025, one-third of units came in the first half and two-thirds in the second half. This trend is expected due to patient out-of-pocket costs in the first part of the year (doughnut hole). Co-pay assistance foundations have gone away with generics on Entresto. We hit roughly 35% of our expected annual revenue in the first half, which is good given headwinds. Inventory shifts between auto-injector and on-body will drive noise in Q3/Q4, but based on history, we expect to achieve the demand. For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-08-06United Therapeutics Q2 Earnings Beat Estimates, Revenues Miss Mark
Zacks
United Therapeutics Q2 Earnings Beat Estimates, Revenues Miss Mark
United Therapeutics UTHR reported second-quarter 2026 earnings per share (EPS) of $7.27, beating the Zacks Consensus Estimate of $6.82. Bottom line increased 13.4% year over year. United Therapeutics markets four products for pulmonary arterial hypertension (PAH): Tyvaso, Orenitram, Adcirca and Remodulin. It also markets Unituxin for the treatment of pediatric patients with high-risk neuroblastoma. Revenues in the quarter totaled $783.3 million, which missed the Zacks Consensus Estimate of $803 million. Top line declined 2% year over year. Year to date, shares of United Therapeutics have rallied 6.5% against the industry’s 3.9% decline. Image Source: Zacks Investment Research A key driver of the company’s top line is Tyvaso products. United Therapeutics markets two versions of Tyvaso, Tyvaso dry powder inhalation (DPI) and nebulized Tyvaso. Both versions are approved for the treatment of PAH and pulmonary hypertension associated with interstitial lung disease (PH-ILD) indications. Combined Tyvaso sales totaled $452.6 million, down 4% year over year due to lower revenues from nebulized Tyvaso. Tyvaso sales fell short of the Zacks Consensus Estimate of $469 million. Tyvaso DPI generated revenues of $326.6 million, climbing 4% year over year due to an increase in patient demand and some pricing benefits. Revenues from nebulized Tyvaso (treprostinil) were $126 million, down 18%, largely due to reduced U.S. demand despite modest price increases. Sales of Orenitram rose 1% year over year to $125.7 million. Remodulin (including Remunity Pump) sales declined 6% year over year to $126.3 million primarily due to lower demand in the United States despite an increase in international revenues. Unituxin sales were up 12% year over year to $65.2 million. Adcirca sales were $6.7 million, roughly consistent with the prior-year quarter. Research and development expenses were $146.3 million in the quarter, up 9% year over year, mainly due to higher spending on clinical programs and a rise in the fair value of contingent consideration liabilities related to acquired manufactured organ and organ alternative projects. Selling, general and administrative expenses declined 3% year over year to $206.7 million in the quarter. As of June 30, 2026, UTHR had cash, cash equivalents and investments of $3.8 billion compared with $3.5 billion as of March 31, 2026. United Therapeutics is pu…Read full documentShow less
United Therapeutics UTHR reported second-quarter 2026 earnings per share (EPS) of $7.27, beating the Zacks Consensus Estimate of $6.82. Bottom line increased 13.4% year over year. United Therapeutics markets four products for pulmonary arterial hypertension (PAH): Tyvaso, Orenitram, Adcirca and Remodulin. It also markets Unituxin for the treatment of pediatric patients with high-risk neuroblastoma. Revenues in the quarter totaled $783.3 million, which missed the Zacks Consensus Estimate of $803 million. Top line declined 2% year over year. Year to date, shares of United Therapeutics have rallied 6.5% against the industry’s 3.9% decline. Image Source: Zacks Investment Research A key driver of the company’s top line is Tyvaso products. United Therapeutics markets two versions of Tyvaso, Tyvaso dry powder inhalation (DPI) and nebulized Tyvaso. Both versions are approved for the treatment of PAH and pulmonary hypertension associated with interstitial lung disease (PH-ILD) indications. Combined Tyvaso sales totaled $452.6 million, down 4% year over year due to lower revenues from nebulized Tyvaso. Tyvaso sales fell short of the Zacks Consensus Estimate of $469 million. Tyvaso DPI generated revenues of $326.6 million, climbing 4% year over year due to an increase in patient demand and some pricing benefits. Revenues from nebulized Tyvaso (treprostinil) were $126 million, down 18%, largely due to reduced U.S. demand despite modest price increases. Sales of Orenitram rose 1% year over year to $125.7 million. Remodulin (including Remunity Pump) sales declined 6% year over year to $126.3 million primarily due to lower demand in the United States despite an increase in international revenues. Unituxin sales were up 12% year over year to $65.2 million. Adcirca sales were $6.7 million, roughly consistent with the prior-year quarter. Research and development expenses were $146.3 million in the quarter, up 9% year over year, mainly due to higher spending on clinical programs and a rise in the fair value of contingent consideration liabilities related to acquired manufactured organ and organ alternative projects. Selling, general and administrative expenses declined 3% year over year to $206.7 million in the quarter. As of June 30, 2026, UTHR had cash, cash equivalents and investments of $3.8 billion compared with $3.5 billion as of March 31, 2026. United Therapeutics is pursuing significant label expansion opportunities for Tyvaso in broader pulmonary fibrosis settings, including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The company's IPF development program consists of two late-stage parallel studies, TETON-1 (conducted in the United States and Canada) and TETON-2 (internationally). The TETON studies evaluated nebulized Tyvaso for the treatment of patients with IPF, a devastating lung disease with limited treatment options. Based on data from the studies, UTHR submitted a supplemental new drug application to the FDA in June for the approval of nebulized Tyvaso in IPF. If the drug is approved for this indication, United Therapeutics expects Tyvaso sales in the IPF indication to exceed the drug’s sales in the PAH indication. Patient enrollment is ongoing in the phase III TETON PPF study evaluating the drug in patients with PPF. Top-line data is expected in the second half of 2027. The company is developing Tresmi, an investigational inhaled treprostinil solution delivered via a soft mist inhaler for the treatment of PAH and PH-ILD. The therapy is designed to reduce coughing by up to 90% compared with Tyvaso DPI. UTHR plans to submit regulatory applications for both indications in 2026, with a commercial launch in 2027, subject to regulatory approval. Another promising late-stage pipeline asset is ralinepag, a potential next-generation growth driver for the company’s PAH franchise. The selective prostacyclin receptor agonist is being developed in two formulations, an oral version and a DPI version (RAL-DPI). The growth of oral ralinepag increased significantly following positive data from the pivotal phase III ADVANCE OUTCOMES study in patients with PAH in March 2026. The study met its primary and secondary endpoints. Based on the data, United Therapeutics recently submitted a new drug application for oral ralinepag to the FDA. Beyond the oral formulation, UTHR is developing ralinepag DPI (RAL-DPI), an inhaled dry-powder version of ralinepag, in collaboration with MannKind Corporation MNKD. While initially targeting PAH, management sees potential opportunities for RAL-DPI in PH-ILD, IPF and PPF. The company plans to file an investigational new drug application later this year. Management expects approval for nebulized Tyvaso in IPF and oral ralinepag in PAH in 2027. United Therapeutics is progressing well with the development of its organ manufacturing business. Last month, the company acquired Thymmune Therapeutics, a Cambridge-based, privately held biotech company developing regenerative thymic cell therapies. The acquisition reinforces United Therapeutics’ commitment to advancing regenerative medicine and expanding the availability and long-term success of organ transplantation. The acquisition added THY-100, Thymmune’s lead investigational therapy, to the company’s pipeline. United Therapeutics Corporation price-consensus-eps-surprise-chart | United Therapeutics Corporation Quote United Therapeutics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, earnings per share estimates for Harmony Biosciences have increased from $3.20 to $3.33 for 2026. Over the same period, estimates for earnings per share increased from $3.64 to $3.87 for 2027. HRMY shares have risen 2.2% year to date. Harmony Biosciences missed on earnings in three of the trailing four quarters and beat in the remaining one, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen to $5.31 from $4.81. LQDA shares have gained 158.4% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report United Therapeutics Corporation (UTHR) : Free Stock Analysis Report MannKind Corporation (MNKD) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-08-06MannKind Q2 Earnings Call Highlights
MarketBeat
MannKind Q2 Earnings Call Highlights
Interested in MannKind Corporation? Here are five stocks we like better. Second-quarter revenue rose 43% to $109.4 million, driven by commercial products and collaboration revenue, but MannKind posted a $19 million GAAP net loss due to planned investments in FUROSCIX, Afrezza, MNKD-201 and the scPharma acquisition. Afrezza sales reached $17 million, while FUROSCIX sales grew 43% sequentially to $22.2 million. The FDA-approved FUROSCIX ReadyFlow autoinjector is expected to launch in August, with management maintaining its $110 million–$120 million annual FUROSCIX revenue outlook and anticipating substantially improved margins. MannKind advanced its pipeline after positive Phase 1b results for inhaled nintedanib in idiopathic pulmonary fibrosis, dosing the first patient in a global Phase 2 trial. A $50 million financing increased pro forma cash to $161 million, although the company expects to pay a $45 million contingent value right in the third quarter. MannKind (NASDAQ:MNKD) reported second-quarter revenue of $109.4 million, up 43% from the prior-year period, as growth in its commercial products and collaboration revenue helped offset increased spending tied to product launches and development programs. The company recorded a GAAP net loss of $19 million for the quarter, compared with net income of $700,000 a year earlier. Non-GAAP net loss was $2.7 million, versus non-GAAP net income of $13.9 million in the second quarter of 2025. Chief Financial Officer Chris Prentiss said the year-over-year change reflected planned investments in FUROSCIX, the pediatric launch of Afrezza, development of MNKD-201, and costs associated with MannKind’s scPharma acquisition. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control Chief Executive Officer Michael Castagna said MannKind’s three major 2026 catalysts had all been achieved: pediatric approval for Afrezza, FDA approval for the FUROSCIX ReadyFlow autoinjector, and positive Phase 1b data for inhaled nintedanib in idiopathic pulmonary fibrosis, or IPF. Afrezza generated $17 million in net sales during the quarter. FUROSCIX generated $22.2 million in net sales, rising 43% from the first quarter, supported by a 49% increase in units sold. Prentiss said higher gross-to-net adjustments, which reached 29% during the quarter, partially offset the increase in units. → 3 Drone Stocks That Should Soar…Read full documentShow less
Interested in MannKind Corporation? Here are five stocks we like better. Second-quarter revenue rose 43% to $109.4 million, driven by commercial products and collaboration revenue, but MannKind posted a $19 million GAAP net loss due to planned investments in FUROSCIX, Afrezza, MNKD-201 and the scPharma acquisition. Afrezza sales reached $17 million, while FUROSCIX sales grew 43% sequentially to $22.2 million. The FDA-approved FUROSCIX ReadyFlow autoinjector is expected to launch in August, with management maintaining its $110 million–$120 million annual FUROSCIX revenue outlook and anticipating substantially improved margins. MannKind advanced its pipeline after positive Phase 1b results for inhaled nintedanib in idiopathic pulmonary fibrosis, dosing the first patient in a global Phase 2 trial. A $50 million financing increased pro forma cash to $161 million, although the company expects to pay a $45 million contingent value right in the third quarter. MannKind (NASDAQ:MNKD) reported second-quarter revenue of $109.4 million, up 43% from the prior-year period, as growth in its commercial products and collaboration revenue helped offset increased spending tied to product launches and development programs. The company recorded a GAAP net loss of $19 million for the quarter, compared with net income of $700,000 a year earlier. Non-GAAP net loss was $2.7 million, versus non-GAAP net income of $13.9 million in the second quarter of 2025. Chief Financial Officer Chris Prentiss said the year-over-year change reflected planned investments in FUROSCIX, the pediatric launch of Afrezza, development of MNKD-201, and costs associated with MannKind’s scPharma acquisition. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control Chief Executive Officer Michael Castagna said MannKind’s three major 2026 catalysts had all been achieved: pediatric approval for Afrezza, FDA approval for the FUROSCIX ReadyFlow autoinjector, and positive Phase 1b data for inhaled nintedanib in idiopathic pulmonary fibrosis, or IPF. Afrezza generated $17 million in net sales during the quarter. FUROSCIX generated $22.2 million in net sales, rising 43% from the first quarter, supported by a 49% increase in units sold. Prentiss said higher gross-to-net adjustments, which reached 29% during the quarter, partially offset the increase in units. → 3 Drone Stocks That Should Soar After the Summer Slump Castagna said marketed-product revenue grew 27% sequentially from the first quarter, while royalties declined 1% over the same period. Excluding collaboration and service revenue, marketed products grew 111% year over year, he said. MannKind’s two commercial products also exceeded royalty revenue as a portion of its underlying revenue mix during the quarter. Royalty revenue from United Therapeutics rose 4% year over year to $32.4 million. Collaboration and services revenue increased 53% to $35 million, primarily due to greater volumes of products sold through to United Therapeutics. MannKind also recognized $4.9 million in ralinepag DPI development milestone revenue. → The Bitcoin Comeback May Already Be Underway—2 ETFs for Exposure Prentiss said manufacturing-related collaboration revenue can fluctuate with production schedules at MannKind’s Danbury facility. Based on current plans, he expects the second quarter to be the company’s highest quarter for manufacturing-related revenue, while full-year revenue should remain in line with the prior year. Afrezza received pediatric approval on May 29, meaning the second quarter contained a limited period of launch activity. Castagna said all 20 of MannKind’s priority pediatric accounts had written at least one prescription, while one-third of the top 100 pediatric rapid-acting insulin prescribers had prescribed the product. The company has emphasized the pediatric diabetes market as a more concentrated and institutionally based opportunity than the adult market. Castagna said approximately 1,000 pediatric prescribers account for 80% of prescriptions in the segment, compared with roughly 60,000 adult prescribers accounting for 80% of rapid-acting insulin prescriptions. He also pointed to support from caregivers, diabetes educators, school nurses, advocacy organizations and social-media communities, as well as more than a decade of Afrezza safety data and recent clinical evidence. MannKind said its $35 access program is intended to reduce barriers to starting treatment. Castagna said more than half of pediatric prescriptions were being filled through cash-pay channels, with the remainder fully paid. The company is pursuing prior authorizations, appeals and payer discussions, and expects its cash-pay program to run through the end of 2026. He said pediatric approval rates have been consistent with adult approval rates. Early prescription activity has included refills and repeat prescribers, according to management. Castagna said more than 30% of customers had written three or more prescriptions based on the company’s available data, though he cautioned that it remains early to assess refill trends. He added that MannKind had seen roughly 450 new prescribers since launch, including about 200 pediatric and 250 adult prescribers. Looking ahead, MannKind expects to introduce a 2-unit Afrezza cartridge in 2027 and is targeting a Bluetooth-connected InhaleIQ device integrated with continuous glucose monitoring. The company also expects higher-concentration Afrezza formulations around 2028, which Castagna said could support larger doses with lower powder loads. MannKind’s FUROSCIX ReadyFlow autoinjector was recently approved by the FDA and is expected to become available later this month. Castagna described ReadyFlow as the only IV-equivalent diuretic delivered through an autoinjector and said the product could support earlier treatment of fluid overload, post-hospital discharge protocols and efforts to reduce readmissions. The product will initially be made available to key institutions and community prescribers. MannKind expects its field teams to complete ReadyFlow training during the week of Aug. 10, with promotion beginning the following week and product shipments occurring in August. Castagna said FUROSCIX growth during the quarter included a 36% increase in institutional delivery network engagement and a 67% sequential increase in nephrology sales. MannKind separated cardiology and nephrology sales-force efforts earlier this year, a move that management said caused some disruption in the first quarter but began contributing to growth in the second quarter. Prentiss said the transition from the on-body infuser to ReadyFlow is expected to improve FUROSCIX margins by about 70%. He said the company anticipates that ReadyFlow will account for a large majority of FUROSCIX volume in 2027. The on-body product could also face tariff effects in future periods, he said. MannKind maintained its $110 million to $120 million annual FUROSCIX revenue outlook. Castagna said second-half demand historically exceeds first-half demand, in part because patient out-of-pocket costs tend to decline later in the year as Medicare coverage dynamics change. He added that inventory movements between ReadyFlow and the on-body infuser could affect quarterly revenue timing in the second half. MannKind also highlighted positive Phase 1b findings for its inhaled nintedanib DPI program in patients with IPF. The company said the seven-day, multiple-ascending-dose study showed no serious adverse events, no bronchospasms, and no discontinuations or dose reductions related to safety or tolerability. Cough occurred in approximately 39% of participants, though Castagna said 60% experienced no cough after inhalation and about 30% reported mild cough. No patients discontinued treatment due to cough, according to the company. The first patient has been dosed in MannKind’s Phase 2 study, and the company expects to activate sites globally throughout 2026. Management has submitted the Phase 2 protocol to the FDA for potential U.S. sites and expects feedback in the fall. Castagna said the eventual registrational path, including the number of required trials and potential expansion into related pulmonary conditions, remains to be determined with the FDA. At quarter-end, MannKind announced a $50 million private investment in public equity financing, giving it a pro forma cash position of $161 million. The company expects to pay a $45 million contingent value right in the third quarter associated primarily with ReadyFlow approval, with approximately $16 million of expense recorded during the quarter. 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). This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "MannKind Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.
Investor releaseQuarter not tagged2026-08-05Compared to Estimates, MannKind (MNKD) Q2 Earnings: A Look at Key Metrics
Zacks
Compared to Estimates, MannKind (MNKD) Q2 Earnings: A Look at Key Metrics
For the quarter ended June 2026, MannKind (MNKD) reported revenue of $109.37 million, up 42.9% over the same period last year. EPS came in at -$0.06, compared to $0 in the year-ago quarter. The reported revenue compares to the Zacks Consensus Estimate of $106.95 million, representing a surprise of +2.27%. The company delivered an EPS surprise of -200%, with the consensus EPS estimate being -$0.02. While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance. As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately. Here is how MannKind performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Revenues- Royalties: $32.37 million compared to the $34.2 million average estimate based on two analysts. The reported number represents a change of +3.7% year over year. Revenues- Commercial product sales: $41.98 million versus $47.43 million estimated by two analysts on average. Compared to the year-ago quarter, this number represents a +87% change. Revenue- V-Go: $2.77 million compared to the $3.89 million average estimate based on two analysts. Revenues- Collaborations and services: $35.02 million versus $25.32 million estimated by two analysts on average. Revenue- Furoscix: $22.19 million versus the two-analyst average estimate of $23.34 million. Revenue- Afrezza: $17.02 million versus $20.22 million estimated by two analysts on average. View all Key Company Metrics for MannKind here>>> Shares of MannKind have returned -6.2% over the past month versus the Zacks S&P 500 composite's +3.5% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report MannKind Corporation (MNKD) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-08-05MannKind: Q2 Earnings Snapshot
Associated Press
MannKind: Q2 Earnings Snapshot
DANBURY, Conn. (AP) — DANBURY, Conn. (AP) — MannKind Corp. (MNKD) on Wednesday reported a loss of $19 million in its second quarter. The Danbury, Connecticut-based company said it had a loss of 6 cents per share. The biopharmaceutical company posted revenue of $109.4 million in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on MNKD at https://www.zacks.com/ap/MNKD
Investor releaseQuarter not tagged2026-08-05MannKind Reports Second Quarter 2026 Financial Results and Provides Business Update
GlobeNewswire
MannKind Reports Second Quarter 2026 Financial Results and Provides Business Update
Achieved three major catalysts to drive future growth: Encouraging early momentum in Afrezza pediatric launch Q2 2026 total revenues of $109.4M, +43% vs. Q2 2025 Conference call and webcast today at 4:30 p.m. ET DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Aug. 05, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD)a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, today reported financial results for the second quarter of 2026, and provided a business update. “This was a transformative period for MannKind, during which we delivered all three major catalysts we set out to achieve in 2026,” said Michael Castagna, Chief Executive Officer of MannKind. “The two recent FDA approvals are expected to fuel our near-term growth opportunities to help patients living with diabetes, heart failure and CKD. The positive Phase 1b INFLO-1 results for MNKD-201 reduces development risk and strengthens our confidence in the ability of our platform to help people living with IPF and other fibrotic diseases. Together, these milestones validate our diversification strategy and position MannKind for sustainable growth.” Business Update and Upcoming Milestones Commercial Products Revenue from marketed products (Afrezza, Furoscix®) grew 27% from Q1 2026 to Q2 2026 Furoscix Furoscix (furosemide injection) generated $22.2 million in net sales for Q2 2026 Continued growth in Integrated Delivery Networks, increasing doses purchased by 36% over Q1 2026 Record number of nephrology units dispensed, increasing by 67% over Q1 2026 Received FDA approval of Furoscix ReadyFlow™ on July 23, 2026, the first and only autoinjector delivering IV-equivalent diuretic therapy for the treatment of edema in adults with heart failure (HF) or chronic kidney disease (CKD); expected to be commercially available in late August Afrezza Afrezza (insulin human) Inhalation Powder generated $17.0 million in net sales for Q2 2026 Received FDA approval of Afrezza on May 29, 2026 for use in children and adolescents ages 6 and older living with diabetes Awarded Breakthrough T1D grant supporting advancement of INHALE-1ST, a pediatric trial of Afrezza in youth with newly diagnosed type 1 diabetes DevelopmentNintedanib DPI (MNKD-201) Topline data readout of U.S. Phase 1b INFLO-1 demonstrates safety…Read full documentShow less
Achieved three major catalysts to drive future growth: Encouraging early momentum in Afrezza pediatric launch Q2 2026 total revenues of $109.4M, +43% vs. Q2 2025 Conference call and webcast today at 4:30 p.m. ET DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Aug. 05, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD)a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, today reported financial results for the second quarter of 2026, and provided a business update. “This was a transformative period for MannKind, during which we delivered all three major catalysts we set out to achieve in 2026,” said Michael Castagna, Chief Executive Officer of MannKind. “The two recent FDA approvals are expected to fuel our near-term growth opportunities to help patients living with diabetes, heart failure and CKD. The positive Phase 1b INFLO-1 results for MNKD-201 reduces development risk and strengthens our confidence in the ability of our platform to help people living with IPF and other fibrotic diseases. Together, these milestones validate our diversification strategy and position MannKind for sustainable growth.” Business Update and Upcoming Milestones Commercial Products Revenue from marketed products (Afrezza, Furoscix®) grew 27% from Q1 2026 to Q2 2026 Furoscix Furoscix (furosemide injection) generated $22.2 million in net sales for Q2 2026 Continued growth in Integrated Delivery Networks, increasing doses purchased by 36% over Q1 2026 Record number of nephrology units dispensed, increasing by 67% over Q1 2026 Received FDA approval of Furoscix ReadyFlow™ on July 23, 2026, the first and only autoinjector delivering IV-equivalent diuretic therapy for the treatment of edema in adults with heart failure (HF) or chronic kidney disease (CKD); expected to be commercially available in late August Afrezza Afrezza (insulin human) Inhalation Powder generated $17.0 million in net sales for Q2 2026 Received FDA approval of Afrezza on May 29, 2026 for use in children and adolescents ages 6 and older living with diabetes Awarded Breakthrough T1D grant supporting advancement of INHALE-1ST, a pediatric trial of Afrezza in youth with newly diagnosed type 1 diabetes DevelopmentNintedanib DPI (MNKD-201) Topline data readout of U.S. Phase 1b INFLO-1 demonstrates safety and tolerability in IPF patients Site activation and enrollment underway in the global Phase 2 INFLO-2 study Ralinepag DPI (MNKD-1501) On track for IND filing by year end Received a $5 million payment from United Therapeutics (UT) to support the rapid advancement of ralinepag DPI Corporate Update Cash, cash equivalents and investments as of June 30, 2026, totaled $111 million Closed $50 million private placement on July 24, 2026; proceeds will fund the $45 million CVR payment triggered by the FDA approval of Furoscix ReadyFlow Second Quarter 2026 Financial Results Revenues Total revenues for the second quarter of 2026 increased compared to the same period in the prior year due to the addition of Furoscix to our product portfolio through the October 7, 2025 acquisition of scPharma, as well as increases in collaborations and services revenue, and royalties. The increase in collaborations and services revenue was primarily attributable to increased product sold to UT and revenue earned related to the development of ralinepag DPI. The increase in royalties was due to UT’s increase in net revenue from sales of Tyvaso DPI. Operating Expenses and Other Financial Highlights Cost of goods sold – commercial, excluding amortization of acquired intangible assets, was $14.4 million for the three months ended June 30, 2026, compared to $4.6 million for the same period in 2025. Research and development expenses were $18.0 million for the three months ended June 30, 2026, compared to $13.7 million for the same period in 2025, an increase of 32%. Selling, general and administrative expenses were $58.3 million for the three months ended June 30, 2026, compared to $31.6 million for the same period in 2025, an increase of 84%. Six Months Ended June 30, 2026 Revenues Total revenues for the six months ended June 30, 2026 increased compared to the same period in the prior year due to the addition of Furoscix to our product portfolio through the October 7, 2025 acquisition of scPharma, as well as increases in collaborations and services revenue, and royalties. The increase in collaborations and services revenue was primarily attributable to an increase in revenue earned related to the development of ralinepag DPI. The increase in royalties was due to UT’s increase in net revenue from sales of Tyvaso DPI. Operating Expenses and Other Financial Highlights Cost of goods sold – commercial, excluding amortization of acquired intangible assets, was $21.9 million for the six months ended June 30, 2026, compared to $8.4 million for the same period in 2025. Research and development expenses were $35.2 million for the six months ended June 30, 2026, compared to $24.7 million for the same period in 2025, an increase of 43%. Selling, general and administrative expenses were $112.4 million for the six months ended June 30, 2026, compared to $56.6 million for the same period in 2025, an increase of 98%. Conference Call and WebcastMannKind will host a conference call and webcast to discuss these results today at 4:30 p.m. Eastern Time. The webcast will be accessible via a link on MannKind’s website at https://investors.mannkindcorp.com/events-and-presentations. A replay will also be available in the same location within 24 hours after the call and accessible for approximately 90 days. About MannKindMannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life. Learn more at mannkindcorp.com. Forward-Looking Statements Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding the timing for expected commercial availability of Furoscix ReadyFlow and the broadened growth potential for Furoscix; the timing of a planned IND filing of ralinepag DPI; expectations regarding MannKind’s ongoing and planned clinical trials and nonclinical studies; and our being positioned for sustainable growth. Words such as “believes,” “anticipates,” “plans,” “expects,” “intend,” “will,” “goal,” “potential,” “prepare,” “opportunity” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with developing product candidates; risks and uncertainties related to unforeseen delays that may impact the timing of clinical trials and reporting data; risks associated with safety and other complications of our products and product candidates; risks associated with the regulatory review process; risks associated with competition; manufacturing risks; market adoption risks; and other risks detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, being filed with the SEC later today. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release. Tyvaso DPI is a trademark of United Therapeutics Corporation. AFREZZA, FUROSCIX, FUROSCIX READYFLOW, MANNKIND, and V-GO are trademarks of MannKind Corporation. Non-GAAP Measures To supplement our condensed consolidated financial statements presented under GAAP, we are presenting non-GAAP net (loss) income and non-GAAP net (loss) income per share – basic, which are non-GAAP financial measures. We are providing these non-GAAP financial measures to disclose additional information to facilitate the comparison of past and present operations, and they are among the indicators management uses as a basis for evaluating our financial performance. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our condensed consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our non-GAAP financial measures; and we may in the futurecease to exclude items that we have historically excluded for purposes of our non-GAAP financial measures. Likewise, we may determine to modify the nature of adjustments to arrive at our non-GAAP financial measures. Because of the non-standardized definitions of non- GAAP financial measures, the non-GAAP financial measures as used by us in this report have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. The following table reconciles our financial measures for net (loss) income and net (loss) income per share ("EPS") for basic weighted average shares as reported in our condensed consolidated statement of operations to a non-GAAP presentation: CONTACT: MannKind Contacts: Investor Relations Kate Miranda Email: [email protected] Media Relations Christie Iacangelo Email: [email protected]
TranscriptFY2026 Q22026-08-05FY2026 Q2 earnings call transcript
Earnings source - 85 paragraphs
FY2026 Q2 earnings call transcript
Good afternoon. Welcome to the MannKind Corporation second quarter 2026 financial results earnings call. As a reminder, this call is being recorded on August 5th, 2026, and will be available for replay on the MannKind Corporation website shortly after this call for approximately 90 days. This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from these expectations. For further information on the company's risk factors, please see the Form 10-Q for the period ended June 30th, 2026, the earnings release, and the slides prepared for this presentation. Joining us today from MannKind, our Chief Executive Officer, Michael Castagna, and Chief Financial Officer, Chris Prentiss.
I'd now like to turn the conference over to Mr. Castagna. Please go ahead, sir.
Thank you, operator. Good afternoon, everyone. Thank you for joining us for our second quarter 2026 call. I'll start with some opening remarks, walk you through some business updates. Chris will talk about our financial results. I'll close by giving a few closing statements here, followed by Q&A. Let me start by saying how we've transformed our company and our potential growth trajectory with the strategy we outlined back in Q1. We laid out three major catalysts this year. Afrezza pediatrics approval, opening an indication opportunity we have not had access to. FUROSCIX ReadyFlow, which we have a CVR around because of the meaningful contribution this will have to the important growth of this franchise. Finally, the Phase I-B readout in the nintedanib DPI in patients with IPF and underlying lung disease.
These three things contribute to a solid foundation as we close out 2026, move into 2027. Beyond the catalysts, Afrezza's off to a very strong start. Our top 20 key institutions have already written a prescription. Breakthrough T1D acknowledged the importance of this opportunity by funding a grant to go after insulin newly diagnosed patients. FUROSCIX showed strong revenue growth with 43% growth just over Q1. Our Phase II inflow study is kicked off and underway with multiple shots on goal in front of us between Tyvaso DPI, ralinepag DPI, and now on the nintedanib DPI, all focused on IPF disease. As we look at Q2 revenues, we grew 21% from Q1 2026 to Q2 2026. What's most important about this picture is when you double-click down, marketed products were 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 of what's driving our growth quarter-to-quarter. Let me talk about our first-tier revenue mix evolution as we look at the success of our diversification strategy that we laid out. When you take out the collaboration and service revenue, we grew 111% on marketed products year-over-year. You can see that the royalties will remain a durable revenue stream for years to come. The predominant revenue growth of MannKind is being driven by marketed products and this crossed a threshold in Q2 from Q1, where our two marketed products now demonstrate faster growth and a higher percentage of our revenue over the royalties by themselves.
The royalties provide a great strong base business as we go forward into our launch trajectories. Let me talk about the launch of Afrezza in pediatrics, which many of you have been asking us about. Now that we're approved, this is the first alternative mealtime injection in over 100 years. This product is solving an unmet need and a challenge that parents and patients face when it comes to timing of administration and seeing the impact that insulin has on their sugars and their CGM. Seeing the ultra-rapid effect of Afrezza, the earlier peak, and the tail coming off allows patients to dose differently and treat their sugars in a way that they just cannot achieve with insulin pumps or injectable insulin.
This is now backed by more than a decade of safety data on the market, clear commercial opportunity, and access at $35 opens up the door for many patients to start this therapy. One of the main questions we get is why do we believe Afrezza will be different in pediatrics than the adult segment? First, the top left, a concentrated, targetable, addressable market. When you think about the adult prescriber base, there's 60,000 adult prescribers that make up 80% of rapid-acting scripts, which include a lot of Type 2 patients. We pivoted about over a year ago to Type 1. The pediatric prescribers are about 1,000 prescribers, make up 80%, and are predominantly institutional-based. Second, there's a connected patient-centric community. We see this online. We see it on Instagram. We see it in education and nurse educators. The adults, we only targeted prescribers.
There was limited surround sound to patients. With the pediatric segment and the success we've had, we've seen noise come from caregivers, from CDEs, school nurses, influencers, and advocacy organizations across the board, driving a lot of demand and questions into the pediatric community. Third, in the bottom left, a stronger clinical foundation and KOL support. When we launched with the adults, we had two studies published and not a lot of top KOL support. As you look at pediatrics, we have some of the top world-renowned thought leaders talking about our data, talking about the unmet need, and the solutions that Afrezza can bring to pediatrics. This is followed by 10 years of safety on the market, new ADA guidelines, the INHALE-1 trial, as well as the INHALE-1 trial being done in the top 50, 60 centers across the U.S. between all of our pediatric development.
Finally is removing friction. We know access is a hurdle for any new launch, and we've basically taken the opportunity to take away all objections around access FEV1 and providing point-of-care opportunities to make sure patients can have a frictionless, seamless experience when they go to start Afrezza. The first eight weeks support these four pillars are driving a different uptake curve than adults. When I look at the names of the institutions on this slide, these are some of the top centers in the country that treat the biggest volume of patients. In fact, one in three of the top 100 pediatric rapid-acting writers have already prescribed Afrezza. We had 20 priority accounts, and all 20 have written at least one prescription since launch. We're really excited by these early metrics, and we'll continue to keep you posted as we go forward.
Before I close on the pediatric launch, I want to talk about the media coverage has really helped convert early momentum. Over 200 markets in all 50 states got episodes on CBS and ABC, as well as numerous articles highlighting the new innovation in pediatrics. This has signaled more demand from HCPs and patients and awareness than we expected. This media credibility is fueling more world engagement, social conversations, and pull-through opportunities that we didn't have otherwise. As I think about the roadmap to success, Afrezza's future includes additional product development, digital advancement, and external innovation. Today, we had updated FDA-approved dose conversion in 2026. We have new guidelines support. Now we have the pediatric approval providing a foundation for global expansion and opportunity.
As we look to 2027, we expect to be able to introduce a 2-unit cartridge, an InhaleIQ, which will be a Bluetooth-connected device integrated with CGM. As we approach 2028, we expect to be able to have high concentration formulations of Afrezza, which ultimately will enable higher doses and lower powder loads at the current doses, minimizing any cough opportunity and increasing cost-effectiveness as we get to higher doses in type 2. Now let me bridge to the FDA approval of the FUROSCIX autoinjector ReadyFlow. As we know, fluid overload across the patient journey is often something that happens at moments in time. The majority of patients can be stable on an oral diuretic at home.
Oftentimes, though, these patients will start to have fluid overload and edema. In the gut, it stops the absorption of not only the diuretic, but also the other meds to treat heart failure, causing a compound effect and worsening of this condition for patients. We often hope that FUROSCIX, in the majority of our use today, is in this early intervention stage in the community setting, where we can hopefully prevent patients from going to the ER and progressing. The opportunity we see tomorrow, especially with this ReadyFlow, is the post-hospital discharge, i.e., can we get patients out of the hospital sooner that are stable or reduce readmissions to prevent the 30-day penalty that many hospitals get for not completely drying out patients before discharge?
We see an opportunity here to increase intervention in the early stage. Start to continue to get post-discharge protocols across the top health systems in the U.S. Since Q1, MannKind advanced several key FUROSCIX growth opportunities. First, we highlight a limited hospital presence. We increased our IDN engagement in hospital systems to drive stronger hospital pull-through. As we see, our medical liaisons are engaging at the highest level on institution protocol development and discharge, as well as our key account managers working with institutions in quality, purchasing, and pharmacy to drive continued contracts and growth opportunities across these IDNs. We saw 36% growth in Q2 over Q1. Second, the team was really focused on trying to launch nephrology while continuing to deliver cardiology sales. We were able to separate those sales force opportunities this year.
We caused some disruption here in Q1, but you can start to see the impact of that effort here in Q2, with 67% growth in nephrology in Q2 over Q1 and a record number of prescribers. We've made many changes to our marketing investments, and you'll start to see those in the second half of this year as we prepare for the Furoscix ReadyFlow launch. We believe those investments will continue to accelerate growth as we close out 2026 and position ourselves for 2027. What does ReadyFlow approval now mean? First, it's the only IV equivalent diuretic delivered via an auto-injector. This will be available in the next 3 weeks to key institutions and community prescribers. This will allow us to deliver treatment from a matter of hours to seconds.
It's demonstrated equivalent urine output, sodium excretion, and potassium excretion to IV furosemide in healthy volunteers. The safety profile is consistent with oral and IV furosemide, and symptom relief may begin in an hour or less. This is a really exciting opportunity to help patients, prevent them from going into the hospital or hopefully getting them out of the hospital early or preventing those one in four patients from going back in. The Furoscix ReadyFlow launch campaign is built to drive immediate awareness and adoption, and we're looking at field activation immediately along with integrated surround sound at the major health systems and opportunities where patients are showing up in these health systems as well as online with the prescribers and patients.
We're excited to be present at these upcoming conferences in the fall, and we expect the awareness of Furoscix ReadyFlow to immediately take off in the coming weeks. I'm going to bridge to nintedanib DPI. This is an exciting opportunity where we just had a quick update last week, and we walked you through the totality of the program. Today I'm just going to give you a few key highlights. Number one, our positive phase I-B study demonstrates safety and tolerability in patients with IPF. We saw no serious adverse events, no GI burden, no discontinuations due to safety, and no difference in spirometry parameters between placebo, which is an empty cartridge, and nintedanib DPI. Our phase II study is underway. Our first patient has been dosed, and we expect to continue to activate sites around the world and throughout 2026.
One of the things I want to highlight before we talk about the PK/PD is that Cmax is known to drive efficacy in pulmonary fibrosis. This means AUC is less of a driver in terms of nintedanib efficacy and hitting a peak threshold concentration matters more than total lung exposure. Beyond the peak, more exposure adds very little added benefit, and this is one of the challenges you have with oral delivered product is it's very hard to get high tissue levels in the lungs. We've known from our preclinical work that we can see significantly higher lung concentrations than plasma by targeting the lungs directly. We believe that brief high peaks are sufficient with short bursts of high concentration to inhibit fibrotic pathways is the data that's been generated out there today on nintedanib.
As I move into our own program, let me talk about the data we have. Our phase I-A validated efficient deep lung delivery of nintedanib DPI. We had rapid dose proportional exposure and a favorable safety profile in our healthy volunteer data. When you look at our phase I-A study, significantly six to eight-fold higher concentration on Cmax in our phase I study compared to a study out there that's been published in nebulized treatment. When you look at the data on the right, our seven-day treatment shows you a dose proportional response when you zoom in on the key attribute here as we're looking at Cmax and AUC. Let me walk you through the data we just released last week. For those that didn't see it, this was the first inpatient study to assess safety, tolerability, and PK in patients with underlying IPF.
This was a 2 cohort, multiple ascending dose study where cohort 1 got two milligrams three times a day, and cohort 2 got four milligrams twice a day, delivered as two-milligram cartridge, i.e., a patient took four cartridges a day in cohort 2. 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 two liters. In our phase I-B study in patients with underlying IPF, we saw a clean safety profile with zero safety signals, zero bronchospasms, and zero discontinuations or down doses. This becomes a challenge when you think about discontinuations with oral therapy can be as high as 50%. This overall profile supports chronic use and de-risks our program as it advances into phase II.
Let me double-click down on the overall treatment adverse events, which was one of the questions we got post our call last week. As you can see here, as previously stated, cough was about 39% in this trial. 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. Let me double-click down on the cough. There were no discontinuations and no serious adverse events. As I stated, 60% of patients had no cough post inhalation, and about 30% of patients had a mild cough. This mild cough is considered transient, does not progress over time, and basically is something that gets better with time as people use the product. When you think about 90% of patients had very mild cough, and none of these were severe.
The cough typically happens with the first dose and does not worsen with time, and this is not a product that you're going to continue to increase the dose over time, so we do not expect the cough to change from this first seven days of treatment. There were over 450 doses administered over seven 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. We're really proud of these results, and we're not surprised given that Technosphere powders have been studied in thousands of patients, and we've seen very low single-digit discontinuations due to cough.
I'm going to turn it over to Chris for our financial results.
Thanks, Mike, good afternoon, everyone. Second quarter revenue was $109.4 million, up 43% year-over-year. First half revenue reached $199.5 million, up 29% over the first half revenue of 2025. At the product level, Afrezza generated $17 million in net sales. Once we are through the initial launch phase for the pediatric opportunity, we intend to provide separate visibility into adult and pediatric performance metrics. As you would expect, because the pediatric indication was approved on May 29th, the quarter included only a limited period of pediatric launch activity. 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.
As we acquired FUROSCIX in October 2025, we are not making prior year comparisons. Our United Therapeutics revenue streams also continued to provide a meaningful contribution. Royalty revenue increased 4% over the second quarter of 2025 to $32.4 million, while 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. As we've noted previously, this revenue stream may fluctuate between periods depending on production scheduling at our Danbury facility across Afrezza, our development programs, and Tyvaso DPI. Based on our production plans, we expect Q2 to be the highest quarter of manufacturing-related revenues, with the annual revenues in line with the prior year.
Overall, the quarter reflects increasing revenue diversification from our promoted commercial products relative to our stable base of UT-related revenues. Turning to the bottom line. 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. 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. The year-over-year change primarily reflects the planned investments to support FUROSCIX, including the ReadyFlow formulation, the pediatric Afrezza launch, investment in our MNKD-201 development program, and the incremental increase in our cost structure following the scPharmaceuticals Inc. acquisition. As you review our non-GAAP adjusted net income, I'd like to call out two lines that are new this year. The first is the amortization of acquired intangible assets.
This relates to our acquisition of the FUROSCIX on-body infuser, which is being amortized over its current expected useful life. Now that the auto-injector 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. It is important to note that the amortization of these intangible assets are non-cash, but we will see these expenses flow through our P&L for many years to come. The other new item relates to the accounting for our contingent value right associated primarily with the recent auto-injector approval. We will pay out the $45 million CVR in Q3, and the balance of expense, approximately $16 million, will be recorded in the quarter.
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, giving us sufficient cash to pay the CVR and continuing to fully support our two launches and accelerate the development of our 201 program. On the expense side, R&D expense was $18 million, compared with $13.7 million in the prior year quarter. The increase was primarily attributable to development of the FUROSCIX ReadyFlow formulation, higher personnel costs following the scPharmaceuticals acquisition, and increased development costs driven by our MannKind 201 program. SG&A expense was $58.3 million, compared with $31.6 million in the prior year quarter. The increase primarily reflected the promotion and support of FUROSCIX, as well as the expansion of our field-based teams and activities to support the pediatric Afrezza and FUROSCIX ReadyFlow launches.
We discussed last quarter, 2026 is a deliberate investment year. With both approvals now achieved, our focus has shifted from launch preparation to disciplined execution. We will continue to monitor performance, prioritize investments behind the opportunities showing the strongest returns, appropriately managing our cost structure. Before I hand it back to Mike, I want to mention that we'll be participating in the Wells Fargo Annual Healthcare Conference in Boston, as well as the Cantor Global Healthcare Conference and the H.C. Wainwright Global Investment Conference in N.Y. We look forward to engaging with many of you there.
With that, I'll turn the call back over to Mike.
Thanks, Chris. Let me close with where this leaves us. I told you at the start of this year that three catalysts would define 2026 for MannKind, we delivered on all three. Afrezza is approved in pediatrics and is launching well. FUROSCIX ReadyFlow is now approved and will be available by the end of this month. The nintedanib DPI showed positive results in phase I with IPF patients, which validated our continued phase II advancement and investment. Our job for the rest of this year is execution, we have the team, the products, and the evidence to make it all happen. Before we take questions, a quick note on where our teams will be this week. First starting out, ADCES, which is the CDE conference. This fall, we'll have a presence at major heart failure nephrology meetings, HFSA and ASN.
The last one I'd like to flag with you is ISPAD in November, where our INHALE-1 pilot phase findings were selected for two oral presentations. That's the pediatric diabetes community's own meeting, having our newly diagnosed data presented there In a launch year is meaningful for how this therapy gets understood by the clinicians who will drive its use potentially around the world.
With that, operator, we'll now turn the call over for questions.
Thank you. The floor is now open for questions. If you would like to ask a question, please click on the Raise Hand button, which can be found on the black bar at the bottom of your screen. When it is your turn, you will receive a message on your screen from the host allowing you to talk, and then you will hear your name called. Please accept, unmute your audio and ask your question. If you have dialed in, please select star nine to raise your hand and star six to unmute. We will wait one moment to allow the queue to form. Our first question will come from Ben Burnett from Wells Fargo. You may now unmute your line and ask your question.
Hey, thanks so much and congrats on the progress. I wanted to ask about Afrezza. You conveyed some good early momentum. I guess what proportion of scripts that you're seeing are coming through your cash program? Do you expect these patients will convert to more standard channels, and if so, when would you expect that?
Thank you, Ben. Great hear from you. When we look at all the scripts dispensed, because we got the hub and then we have some IQV data we're reconciling, but we are seeing a good portion go through as fully paid, and we're seeing the other half at least go through as cash. It's too early to tell how quickly that will convert, but obviously we're pursuing the prior authorizations and the appeals to make sure patients get it. In parallel, we're also meeting with payers as we're trying to continue to increase cost and coverage for patients, especially as we go into 2027. This program is going to go through the end of 2026, and we would hope by then we work through most of the payers to move forward there.
So far, I can tell you our pediatric approval rates are consistent with the adult approval rates. That's one indicator what we're looking at. Otherwise, there is more than half going through as cash, but we expect many of those to convert to paid.
Our next question comes from Olivia Saunders from Cantor. Please unmute your line and ask your question.
Hey, good afternoon, guys. Thank you for the question. I know it's obviously very early in development still. Can you maybe help walk us through how you're thinking about the regulatory path forward for your IPF program? Obviously, the ongoing phase II will be a big part of that. What feedback have you gotten maybe more recently from the FDA around what you'll need to get this to patients and whether there are things that you can do to help accelerate that path forward? As a follow-up, is PPF something that you guys are looking into at this point as you think about your long-term portfolio, just given how big of a market it is and how much R&D interest there seems to be around it right now?
Thank you, Olivia. Great questions. Obviously, we're very excited about just the nintedanib IPF opportunity. To your point, we will continue to look at IPF, PPF, ILD, and all the indications related to nintedanib. We did meet the FDA last year as we finished up our phase I to go to phase II. We originally proposed a phase II/III study because most of the time in starting these trials is site activations, and we're trying to minimize that. At that point, that's why we decided to do the phase I-B to minimize any distraction related to FDA feedback. They really wanted to know what the patterns look like in patients with IPF. We've now demonstrated that. We have submitted the phase II protocol to the FDA to open up potential U.S. sites. We'll have feedback on that in the fall.
I think you've seen the FDA indicate probably one trial is probably all that will be required in addition to the phase II. That's our underlying assumption. Again, the FDA will have to confirm some of those. I think depending on the significant effect size that we may or may not see, that's probably going to drive some of this other indication extrapolation discussions versus do you need additional studies. The pulmonary division is very different than the other divisions. I think it's still TBD. We're going to learn like you see on Tyvaso DPI, as UT talks to the FDA, we'll learn things there. There was indication extrapolation in DPI for ILD. I think UT still needs to work through that on Tyvaso DPI. A lot of precedent setting around this set of patients and unmet need.
I think a lot of it with the FDA will determine the effect size and how much they understand this. Too early to tell, is it two trials, one trial, each indication extrapolation? Our working assumption is at least one trial for IPF and likely additional data generated in other target populations. That's our working assumption. Will we do that in parallel to IPF? I think that's still TBD of how many bets we want to place simultaneously, but we want to make sure we establish the dosing here in phase II.
Our next question will come from Roanna Ruiz from Leerink. Please unmute your line and ask your question.
Hey, guys. You have Ryan on for Roanna. Thanks for taking our question and congrats on the quarter. Maybe going back to Afrezza, can you guys just help us understand the pace of script trends that you're seeing in the pediatric setting over the last month or two? As your reps spend more time in the field, are you seeing an acceleration of scripts or steady growth? Just as we look out in a couple quarters and years, how do you expect this mix of adult and pediatric scripts to trend? Thanks.
Thank you, Ryan. What I'd say is in the first week or two, there was obviously a bolus of patients waiting for approval, and we saw a really fast submissions and getting those sites on board and our team getting out there to get them to use our reimbursement hub. I've been out there in the field. The excitement is palpable with the customers, the patients, the social media, and you saw even though we had July 4th holidays, and people on vacation, we've seen a nice, consistent, steady referral pattern into our reimbursement hub. The last two weeks, you're starting to see that build up with potential refills as well as momentum. I expect continued momentum as the quarter and the months progress ahead. We're also adding another, call it 1,000 targets roughly, in the pediatric community to our 70 reps who are selling Afrezza for adults.
They will now be kicking in here in August, we're actually training them next week. I expect continued momentum building, it is a nice, steady group every week, it has been growing the last few weeks as well. I think we hit our highest week, a week and a half ago, of the past eight weeks. It is growing, and we are hitting new peaks every week, and that's exciting. We think we're just getting started here. How that builds will be part of what we're looking for in terms of Obviously, you want to know how to build your models, us too, right? We're making lots of investments here, and we want to see how the refill patterns look, how's the adult coming in, and where are these patients coming from? We just got research this morning.
The good news is we're seeing significant number of patients are coming from MDI. They're using Afrezza full-time, probably 60%-70%, about a third are using it intermittently, that means they may take a pump break, they may use it on top of their pump. We are seeing a large percentage of people say they will use it full-time, and a lot of good patient demand for it. That's the overall picture I'd say for peds. Happy to dig in in terms of some of our biggest prescribers are asking every patient on every visit, "Do you want to try inhaled insulin?" We've seen some people write over 20-30 patients already. On the adult side, I want to remind people, we pulled back resources this year on the adults.
Obviously we see a little softness in Afrezza year-over-year, that's related to really the top 10 prescribers had a disproportionate amount of decrease relative to the next 1,000. When you take away that top 10, you look at the underlying 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. I do think we'll start to see the compound in the second half of Afrezza adult and peds. If you ask me personally, I think the peds response, the uptake, the number of patients coming in, the number of prescribers, the feedback, everything points to peds will continue to build momentum.
In adults, we want to hold steady, we believe the adult segment will grow with peds. Just to give you some color, we had roughly It's on my notes page, sorry. We had roughly about 450 docs come in since launch that are new prescribers, this is just one part of the data, not all the data, but on the conservative side. Of those, about 200 were peds and about 250 were adults. You're seeing more adults coming in with the peds approval and the confidence. We had about 1,800 writers of Afrezza since the June 1st launch. We're seeing overall writing increase, we're seeing repeat writing increase, and we're seeing new writers increase. That broad base of prescribing, I'll say, is what we're watching and seeing how much we can get depth and breadth of that audience.
Our next question will come from Gregory Renda from Truist Securities. Please unmute your line and ask your question.
Hey, guys. It's Nishant for Greg. Congrats on the quarter and for taking our questions. Just first on the Afrezza peds share source, with the previously quoted 23%-37% peds share range, how much assumes conversion of pumps and pods versus capture of multiple daily injection patients? Second, on the 201 registrational path or nintedanib DPI, what is the shortest credible route to approval? Does the study need to show FVC benefit on top of background antifibrotic therapy, or non-inferiority to oral nintedanib? Thanks so much.
Okay. I'll just keep building on the Afrezza theme. Then I'll jump into 201. On the overall data, we would expect roughly half our patients to come from MDI and maybe 20%-30% to come off pumps or added to pumps, and then the remaining 15%-20% be insulin-naive patients. So that's the segment that we're seeing some early data. We got almost maybe 20% of the naive trial enrolled already. The two-unit cartridge is really going to be helpful for the naive setting, but I think in terms of MDI and pumps, that's the majority of our patients coming in today, are patients coming from MDI or people wanting a pump break. That's been some of the anecdotal feedback from doctors as they offer it to everybody.
They didn't realize that people have burnout, and that they're tired, and they'd love to be detached from something for a little while. It doesn't mean they're always going to use Afrezza full-time or a pump full-time. They're going to go back and forth realistically, depending on their needs. That gives you a breakdown of Afrezza. I would say the research we just got in this morning reiterated that kind of breakdown of what we're seeing in our initial launch assumptions and how it's being used in the first six weeks and how we expect to see that continue on. Also, the research that came in reiterated the 20%-30% share that we talked about previously, that the doctors, now that that approval is there, they're continuing to indicate that's a real possibility.
We're continuing to remain bullish and excited here for what we see in the early days, it'll take time to show these trends. The last thing I'll say on Afrezza is just some of the pharmacies are reporting, some of them are not reporting, that noise will sort out, and we'll continue to keep you updated. We are working through that consistently as Wall Street may try to look at one data source but not have the full data. On MNKD-201, that's an interesting question in terms of the fastest pathway. Having done a lot of biosimilars, my initial goal was to convince the FDA that a biosimilar-like pathway could be appropriate here, meaning a non-inferiority trial with indication extrapolation.
I think we need to get the phase II data to show the effect size to alleviate any concerns that we'd be putting this in a large population and not knowing, are you switching off stable nintedanib to inhaled versus an add-on. I don't think the FDA has any clear guidance on what they prefer, but I think what they would like is an add-on design trial with placebo, the good news with the Jascayd launch, there's clearly going to be more patients to add on top of background therapy, especially as we look at Tyvaso nebulizer. I'm hopeful as we get to phase III, the ability to look at naive patients as well as add-on and enroll that trial quickly will happen, and that's our assumption. The size of the trial and the primary endpoints will be TBD.
That's really what I look at the IPF market as saying. If it was only nintedanib and it had to be an add-on, it would be a hard study to enroll, given the success of Jascayd and pirfenidone and Tyvaso nebulizer coming in, I'm excited about the phase III design here.
Our next question comes from Brandon Folkes from H.C. Wainwright. Please unmute your line and ask your question.
Hi, thanks for taking my question and congrats on all the progress recently. I'll just continue on the Afrezza theme. Understanding it's very early on, any color on refills or prescribers writing repeat prescriptions? In terms of titration and equivalent dosing, you've generated good data there, but is that resonating or well known with the pedes prescribers right now, or is there a similar learning curve to the adult launch, but this time you're doing it with the data in hand?
We are seeing refills already in month two, that's a good sign, but it's too early to tell how that builds. I think we're going to need another month or two of data to really look at those trends in the cash pay and compare it to the IQVIA data. We did see almost a 50% jump in new to brand therapy just in June alone. We'll have July very shortly. That's all positive. In terms of if I think about how many docs wrote three or more scripts, over 30% of our customers have written three or more scripts from what we can see. That number's probably being conservative because there's some duplication we're trying to eliminate.
We do see people already writing their second and third patient coming into our referral hub as well as in that IQVIA data. That's another exciting sign that we are seeing the repeat writing happen, let alone the refills. In terms of the learning curve, we tried to apply, as you saw, why do we think this is different from adults? We don't want to make the same perceived objections in adults. One of the things that came back today, for example, was cost. We're charging $35, yet the perceived cost by the customers is in line with an insulin pump or injectable insulin. The good news is they're not perceiving cost to be a barrier, which is one of the ones we hear in adults. The other thing that's coming up is lung safety and lung testing.
That's another one we want to continue to work through the system and make sure that those are not barriers. If you look at the top 20 institutions, two of them just wrote last week because it took them seven weeks to figure out how to get the lung function test embedded in their clinical practice. That's done now, and that continues to be less of a burden as we go forward. The dosing, I think that the change in the label brings people confidence on the conversion because when you're talking about kids or adults and insulin, everyone's told if you dose too much, you go low and you don't do well. That dosing change is bringing people confidence to start with the appropriate dose and titrate up, but most importantly start. I think that's what that label change has gotten us.
That should result in less dropouts. Again, too early to tell that's one of the things we'll be looking for.
Our next question comes from Yun Zhong from Wedbush. Please unmute your line and ask your question.
Hi. Good afternoon. Thank you very much for taking the questions, congratulations on the progress. On the Afrezza pediatric launch, I wanted to ask about the You said one in three of the top 100 pediatric insulin writers, what about the other two? Have they not been reached, are they still trying to figure out maybe whether it's suitable for their patient, have they not received sufficient interest level from their patients? If there is any additional information that you're able to provide, that would be very helpful. On the ReadyFlow launch, I know that three may not sounds like a big deal, what needs to happen during that three weeks now that you are not able to launch immediately after the FDA approval? Thank you very much.
Yeah. I think on the one-third, these are the top 100 insulin writers. You could imagine it's very hard to get into these places. Many of them are in academic institutions. You have a lot of people taking summer vacations. In some cases, we have in-services scheduled in the month of August and September. They're not always going to be there in the first 30 days. In many cases, we've been asked to come in ahead of our original in-service date in-service to staff even earlier because of how many patients are coming and asking. I'd say the other two-thirds, there's probably always going to be 10, 20% of docs who are never going to write. The fact is, we're just getting started here, in the first eight weeks, I think we're pretty happy with one-third.
I think that will continue to close the gap. There's nothing specific that I would sit here and say today, other than time, of why the other two-thirds have not written. There's no major objections happening, and I think that's what's most important. I've been doing this for 10 years on Afrezza. I go out there at pedes, and people want to. They're not arguing why they shouldn't use it. They're trying to learn how to use it. That's a very big difference in my experience from adults. They're asking the right questions. I can tell you, I did a dinner in a key part of the country, 15 providers showed up, and they held me for three and a half hours of just discussion. That was just their open time.
They wanted to stay and continue to understand every nuance of this product over the last 10 years. That's the level of detail people are getting into in a good way, because they want to learn how to write it, how to prescribe it, how to titrate it, and how to really think about using it, because it is so different than all the other insulins. That's the good part about the pedes that we're excited about, is it's an audience that is more engaged, more open to change, and they are more progressive than the adults. So far, we are seeing that. On the ReadyFlow, unfortunately or fortunately, depending on what you want to look at, the supply chain is outsourced. Now, the good news is ReadyFlow's in the U.S. versus the on-body infusers outside the U.S.
That supply chain across the U.S. just takes time. We had to get the labels, we had to get the packaging, we had to get things printed, we got to fit in the queue of the outsourced providers. All that's been lined up, and the team is working tirelessly day and night to make sure we get there every day we can. At this point, we've set the target. We're training all the reps next week, the week of August 10th, and the following week, they'll be out there promoting it, and inventory should be there by the end of that week or the following Monday. We'll be shipping drug in the month of August, for all intents and purposes. The product's made, so there's no worry so far that we have around is there a manufacturing or anything like that.
It's just really the supply chain.
Our next question comes from Anthony Petrone from Mizuho Financial Group. Please unmute your line and ask the question.
Thanks. Congrats on all the progress this year. One on Afrezza and one on ReadyFlow. I think, Mike, we talked about the additional doses at the upper end of the range for Afrezza, pediatric Afrezza. Maybe when will those be available? Once all of the cartridges are available, what do you think the mix will be in terms of dosing? How does that translate into gross margin contribution? Because you have some pricing at the upper end of the range there with the larger dose cartridges. On ReadyFlow, the transition to sub-Q from on-body as a gross margin uplift. I'm just thinking as you go into 2027 and we look at product gross margin, specifically when you have that higher mix to ReadyFlow, how should we think about product gross margin year-over-year from 2026 to 2027? Thanks.
All right. I'll take the first one, I'll punt the second one to Chris. On the Afrezza doses, I would say that work on the high doses will take another 12-18 months realistically. Then we got to get that approved. We have submitted or are in the process of submitting that request to the FDA to understand and make sure we follow the bracketing approach we're looking for. On the smaller doses, the 2 unit, that work has already been done. It's already on stability. We've already asked FDA about it. We feel pretty good about getting a smaller dose into the market, hopefully in 2027. I think that's more important in the short term as we continue to get the pediatric market going.
Even the adult market, I'd say more the type 1 market, they're so used to thinking about half unit, 1 unit increments, that a 2-unit cartridge really allows them to either start earlier in that honeymoon period when they're newly diagnosed or to titrate between a four and an eight to get to six, or an eight and a 12 to get to 10. There are patients who just want to get that accurate. I don't think it's personally required, but you're changing 100 years of habit, insulin sensitivity ratios, and carb counting. They've been trained a certain way. We can either try to retrain all of society, or we can try to fit into the model that they're used to. I think the barrier to just fit into the model they're used to is going to make these incremental doses easier.
I wouldn't expect a lot of change on gross margin, between the different doses. It'll help on the fringes. I think it's really going to help international. When I look at international markets, cost is a huge barrier. People are paying cash, and being able to continue to reduce the cost outside the U.S. will only increase adoption there. Otherwise, you're going to be limited to a very small population until we can get these higher doses into a single cartridge instead of two cartridges, because that literally costs them two to three times as much. That will be a hindrance to global expansion. In the U.S., the high doses in type 2s will be an opportunity to continue to grow as the type 2 market wants to use Afrezza as well. The high doses are important.
They're not as important in the next 18 months. They'll be there. Chris, I'll turn it over to you for the ReadyFlow and contribution.
As we think about the FUROSCIX margin, our commentary has been that the margin increases by about 70% when we think about the transition from OBI to the ReadyFlow. As you start thinking about your model for 2027, you can start thinking about a large majority of that being the ReadyFlow. That will have a significant help for us. The on-body, in reality, will be impacted by tariffs that are soon coming into play. That difference between margin would be even exacerbated as we think about future periods.
Our final question is coming from Douglas Miehm from RBC Capital Markets. Please unmute your line and ask your question.
Thank you. My question just has to do with FUROSCIX. When you look at the first half of the year, the $38 million or so that you reported and achieving the guidance of $110 million-$120 million, it implies around $75 million plus or minus a bit in the second half of the year, so roughly doubling or so the first half of the year. With the launch occurring later in August, can you just walk us through the cadence and key assumptions that would give you confidence that the guidance range is achievable? Thank you.
Thank you, Doug. I'd say a couple things on this topic. First, if you look at 2025, one-third of the units came in in the first half, and two-thirds of units came into the second half of last year. I think that trend is probably what we expect until you start to see either smoothing in Medicare come in more aggressively, or there's some way to provide assistance, or we move more formularies to preferred status. That patient out-of-pocket cost in the first quarter to as people close the donut hole, it is a major barrier to that earlier unit adoption. You see the back half of the year as co-pays come down. There's a huge unmet need. Patients just can't afford it. That's not a thing that MannKind can change. It's not just our product, it's all brands.
The co-pay assistance foundations this year went away pretty much with the generics that came in on Entresto. A lot of that assistance that was out there has gone away for these patients. The fact that we did hit roughly 35% of what we expect for the year in the first half, I think is great given some of the headwinds that are out there and the patient affordability. If you just do that, your numbers are roughly directionally accurate of what we expect in the first half and second half. The only thing I'll add to it in terms of can we or can we not achieve that guidance range is the inventory's going to be shifting quite a bit over Q3 and Q4 between the auto-injector and the on-body infuser.
Depending on how that conversion and how fast it happens and those inventory buying patterns, that's going to drive a lot of that noise I'll see in that range. Things look pretty good, but obviously the second half's got a large demand number in front of it, and based on history, we expect that we can achieve that demand. The inventory part will also be another factor here we're driving towards.
Thank you.
There are no further questions. Back to Michael Castagna for closing remarks.
Thank you, everyone, great questions. It's somewhat refreshing or concerning that we're all talking about Afrezza, but we're really excited about the pediatric launch opportunity we see in front of us. We're happy to hit all three milestones this year. These were amazing, hard work on a lot of people and a real big part of the future of the company. I think 406 ReadyFlow, we're jazzed what that's going to do for patients and providers and hopefully to launch trajectory there in the second half, really is going to bring a lot of energy and momentum to the company. I want to thank, really, the patients, the families, our investigators who do all of our trials. We couldn't be here without them, and our employees who honestly have worked night and day and weekends to make sure we got through the FDA and got these approval.
Now they're preparing for the launches. A lot of people working a lot of long hours on your behalf. Everything we discussed today starts and ends with everyone involved. Thank you to our employees and stakeholders. We look forward to updating you on our progress next quarter. We have three or four investor meetings between now and then. We'll continue to share updates on the launches and how things are progressing at those opportunities. Please dial in and listen, and we're always available for questions if you want to reach out. Thank you, operator. This ends today's call.
That concludes today's call. You may now disconnect.
Investor releaseQuarter not tagged2026-07-29MannKind Reports Positive Phase 1b INFLO-1 Results, Demonstrating Safety and Tolerability of Nintedanib DPI and Clinical Validation of Its DPI Technology in IPF
GlobeNewswire
MannKind Reports Positive Phase 1b INFLO-1 Results, Demonstrating Safety and Tolerability of Nintedanib DPI and Clinical Validation of Its DPI Technology in IPF
Generally well-tolerated with no serious adverse events, bronchospasm or diarrhea; no study drug discontinuations 90% of patients had no [60%] or mild [30%] cough ~450 total inhalations administered in patients with IPF Global Phase 2 INFLO-2 trial actively enrolling patients Conference call and webcast scheduled for July 29 at 4:30 p.m. ET DANBURY, Conn. and WESTLAKE VILLAGE, Calif., July 29, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company focused on developing innovative, patient-centric therapies for chronic diseases, today announced positive topline results from INFLO-1, its Phase 1b randomized, double-blind, placebo-controlled study evaluating nintedanib dry powder inhalation (DPI) in patients with idiopathic pulmonary fibrosis (IPF). The study met its primary objective, demonstrating that nintedanib DPI was generally safe and well tolerated in patients with IPF. The Phase 1b study enrolled 27 patients across 10 U.S. sites and evaluated two multiple-ascending dose regimens of nintedanib DPI administered over seven days. INFLO-1 Topline ResultsKey findings from the study included: No serious adverse events No drug-related gastrointestinal side effects (i.e., diarrhea, nausea, vomiting) No bronchospasm events No treatment discontinuations or dose reductions No differences in spirometry parameters between nintedanib DPI and placebo (empty cartridges) Most patients experienced no cough; reported cough events were predominantly mild, transient and resolved Additional data will be presented at a future conference. "The INFLO-1 results represent an important milestone for our nintedanib DPI program and further validates the potential of our Technosphere® platform in pulmonary fibrosis," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "Across our Phase 1a and Phase 1b studies, participants have received more than 700 inhalations of nintedanib DPI, including nearly 450 inhalations administered to people living with IPF. Importantly, cough was not a meaningful barrier to treatment. When observed, cough events were generally mild, transient and resolved, with no cough-related discontinuations or dose reductions. These findings provide growing confidence as we continue to advance Phase 2 development." Phase 1a Program Established Foundation for Clinical DevelopmentThe INFLO-1 findings build u…Read full documentShow less
Generally well-tolerated with no serious adverse events, bronchospasm or diarrhea; no study drug discontinuations 90% of patients had no [60%] or mild [30%] cough ~450 total inhalations administered in patients with IPF Global Phase 2 INFLO-2 trial actively enrolling patients Conference call and webcast scheduled for July 29 at 4:30 p.m. ET DANBURY, Conn. and WESTLAKE VILLAGE, Calif., July 29, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company focused on developing innovative, patient-centric therapies for chronic diseases, today announced positive topline results from INFLO-1, its Phase 1b randomized, double-blind, placebo-controlled study evaluating nintedanib dry powder inhalation (DPI) in patients with idiopathic pulmonary fibrosis (IPF). The study met its primary objective, demonstrating that nintedanib DPI was generally safe and well tolerated in patients with IPF. The Phase 1b study enrolled 27 patients across 10 U.S. sites and evaluated two multiple-ascending dose regimens of nintedanib DPI administered over seven days. INFLO-1 Topline ResultsKey findings from the study included: No serious adverse events No drug-related gastrointestinal side effects (i.e., diarrhea, nausea, vomiting) No bronchospasm events No treatment discontinuations or dose reductions No differences in spirometry parameters between nintedanib DPI and placebo (empty cartridges) Most patients experienced no cough; reported cough events were predominantly mild, transient and resolved Additional data will be presented at a future conference. "The INFLO-1 results represent an important milestone for our nintedanib DPI program and further validates the potential of our Technosphere® platform in pulmonary fibrosis," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "Across our Phase 1a and Phase 1b studies, participants have received more than 700 inhalations of nintedanib DPI, including nearly 450 inhalations administered to people living with IPF. Importantly, cough was not a meaningful barrier to treatment. When observed, cough events were generally mild, transient and resolved, with no cough-related discontinuations or dose reductions. These findings provide growing confidence as we continue to advance Phase 2 development." Phase 1a Program Established Foundation for Clinical DevelopmentThe INFLO-1 findings build upon previously reported results from MannKind's completed Phase 1a first-in-human study in healthy volunteers. In that study, nintedanib DPI demonstrated favorable safety and tolerability with no serious adverse events, no discontinuations, and no safety signals identified. Pharmacokinetic analyses demonstrated rapid absorption and dose-proportional increases in plasma concentrations consistent with deep-lung delivery following inhalation. Across the completed Phase 1a and Phase 1b studies, a total of 48 individuals have received nintedanib DPI, 18 of whom were patients with IPF, providing the largest reported clinical dataset with an inhaled nintedanib therapy in patients with IPF to date. Global Phase 2 INFLO-2 Study UnderwayMannKind's global Phase 2 INFLO-2 study is actively enrolling patients with IPF. The randomized, double-blind, placebo-controlled trial is expected to enroll approximately 210 participants across approximately 85 sites worldwide and is designed to further evaluate the safety, tolerability and efficacy of nintedanib DPI. Participants are being randomized to receive either nintedanib DPI (2mg four times daily or 4mg twice daily) or placebo for 12 weeks, followed by a 24-week open-label extension in which all participants will receive active treatment. The primary objective of the study is to assess safety and tolerability of nintedanib DPI. Secondary objectives include evaluating a potential efficacy signal, including the annualized rate of decline in forced vital capacity (FVC), a key measure of lung function in IPF. Additional endpoints will assess disease progression, pulmonary exacerbations, exercise capacity, patient-reported outcomes, and pharmacokinetics. About INFLO-1INFLO-1 was a Phase 1b, randomized, double-blind, placebo-controlled study of nintedanib DPI in patients with IPF. The U.S. trial consisted of multiple ascending doses (MAD) with the primary objective to evaluate safety, tolerability and pharmacokinetics of nintedanib DPI compared to placebo in patients with IPF. More information on INFLO-1 is available at: ClinicalTrials.gov (NCT07344558). Differentiated Approach to a Significant Unmet Need IPF is a chronic, progressive lung disease characterized by irreversible fibrosis and declining lung function. Despite available therapies, the disease remains associated with substantial morbidity and mortality. Nintedanib, currently approved as an oral therapy for IPF, has demonstrated the ability to slow disease progression but can be associated with systemic side effects that may limit tolerability, treatment persistence, and the ability to use combination therapies. Nintedanib DPI (MNKD-201) leverages MannKind’s Technosphere® dry powder inhalation technology to deliver nintedanib directly to the deep lung, with the goal of achieving therapeutic concentrations at the site of disease while reducing systemic exposure. MannKind has developed two FDA-approved dry powder inhalation therapies utilizing its proven Technosphere formulation technology, with clinical data demonstrating less than 3% discontinuation due to cough in adult patients. About IPFIdiopathic pulmonary fibrosis is a chronic, progressive lung disease characterized by irreversible scarring of lung tissue that leads to worsening lung function over time. Despite available therapies, IPF remains associated with significant morbidity and mortality. According to the American Lung Association and GlobalData, there are an estimated 100,000 IPF patients in the U.S. with a 20% rise in the last decade. IPF affects an estimated 1-1.5 million people worldwide, based on global prevalence analyses reporting approximately 13-20 patients per 100,000 population.1 Investor CallManagement of the Company will host a conference call to discuss results at 4:30 p.m. ET on July 29, 2026. Presenting from the Company will be its Chief Executive Officer, Michael Castagna, PharmD, and Wassim Fares, M.D., MSc, FCCP, Senior Vice President, Therapeutic Area Head – Respiratory. To view and listen to the webcast, visit MannKind's website at https://investors.mannkindcorp.com/events-and-presentations. A replay will also be available on MannKind's website for approximately 90 days. About MannKindMannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life. Learn more at mannkindcorp.com. Forward-Looking Statements Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. Forward-looking statements include statements regarding the continuing development of MNKD-201 and the potential of our platform in pulmonary fibrosis. Words such as “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that continued testing of a drug may not yield successful results or results that are consistent with earlier testing, and other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release. MANNKIND and TECHNOSPHERE are registered trademarks of MannKind Corporation. 1 National Library of Medicine (U.S.). Idiopathic pulmonary fibrosis. MedlinePlus Genetics. Available at: https://medlineplus.gov/genetics/condition/idiopathic-pulmonary-fibrosis/. CONTACT: MannKind Contacts: Media Relations: Christie Iacangelo (818) 292-3500 [email protected] Investor Relations: Kate Miranda (781) 301-6869 [email protected]
Investor releaseQuarter not tagged2026-07-28MannKind to Report Second Quarter Financial Results and Host Conference Call on August 5, 2026
GlobeNewswire
MannKind to Report Second Quarter Financial Results and Host Conference Call on August 5, 2026
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., July 28, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), today announced that the Company will report second quarter 2026 financial results after market close on Wednesday, August 5, 2026. MannKind’s management team will host a conference call at 4:30 p.m. Eastern Time to review the financial results and provide a business update. The webcast of the conference call will be accessible via a link on MannKind’s website at https://investors.mannkindcorp.com/events-and-presentations. A replay will be available in the same location within 24 hours following the call and will be accessible for approximately 90 days. About MannKind MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life. Learn more at mannkindcorp.com. CONTACT: Contacts: Investor Relations Kate Miranda (617) 921-5461 Email: [email protected] Media Relations Christie Iacangelo (818) 292-3500 Email: [email protected]
Investor releaseQuarter not tagged2026-07-20What This MannKind Director Sale Signals With $32.7 Million in Quarterly Royalties Revenue Potentially at Risk
Motley Fool
What This MannKind Director Sale Signals With $32.7 Million in Quarterly Royalties Revenue Potentially at Risk
Director Steven B. Binder disclosed a disposition of 76,880 shares of MannKind Corporation (NASDAQ:MNKD) at $4.07 per share in transactions completed on July 15, 2026, and July 17, 2026, according to a recent SEC Form 4 filing. Transaction value based on SEC Form 4 weighted average sale price ($4.07); post-transaction value based on July 17, 2026 market close ($4.03). What was the primary mechanism for this transaction?The disposition was a structured liquidation resulting from the vesting of performance-based restricted stock units (RSUs). Approximately 24,000 shares were withheld by the company to satisfy mandatory tax obligations, and 52,485 shares were sold via a pre-arranged Rule 10b5-1 trading plan. This setup allows insiders to manage portfolio liquidity and diversification following major vesting events. How did the company's market performance influence the vesting criteria?The underlying equity was delivered after MannKind achieved the 41.5th percentile of total shareholder return relative to the Russell 3000 Pharmaceutical & Biotechnology Index. This performance level triggered an 83% achievement of the target objective established in May 2023, resulting in the net delivery of 93,790 shares to Steven B. Binder prior to the reported sales. What is the scale of the insider's remaining investment?Following the reported activity, the director maintains a direct interest in 824,918 shares. This position was valued at $3.32 million as of the July 17, 2026 market close. The stock has generated a 3% return over the past 12 months as of the transaction date. What are the fundamental financial metrics for MannKind?For the trailing twelve months, the company reported revenue of $360.8 million and a net loss of ($23.9 million). The firm is headquartered in Danbury and focuses on the U.S. biopharmaceutical market for rare lung conditions and endocrine treatments. MannKind Corporation develops and commercializes respiratory-delivered biopharmaceutical treatments, with its flagship product Afrezza, an inhaled insulin formulation designed to improve glycemic control in adults with diabetes, serving as the primary revenue driver. The company generates revenue through direct pharmaceutical sales of its approved products to healthcare providers and patients, leveraging its proprietary pulmonary delivery technology platform to differentiate its therapeutic offerings…Read full documentShow less
Director Steven B. Binder disclosed a disposition of 76,880 shares of MannKind Corporation (NASDAQ:MNKD) at $4.07 per share in transactions completed on July 15, 2026, and July 17, 2026, according to a recent SEC Form 4 filing. Transaction value based on SEC Form 4 weighted average sale price ($4.07); post-transaction value based on July 17, 2026 market close ($4.03). What was the primary mechanism for this transaction?The disposition was a structured liquidation resulting from the vesting of performance-based restricted stock units (RSUs). Approximately 24,000 shares were withheld by the company to satisfy mandatory tax obligations, and 52,485 shares were sold via a pre-arranged Rule 10b5-1 trading plan. This setup allows insiders to manage portfolio liquidity and diversification following major vesting events. How did the company's market performance influence the vesting criteria?The underlying equity was delivered after MannKind achieved the 41.5th percentile of total shareholder return relative to the Russell 3000 Pharmaceutical & Biotechnology Index. This performance level triggered an 83% achievement of the target objective established in May 2023, resulting in the net delivery of 93,790 shares to Steven B. Binder prior to the reported sales. What is the scale of the insider's remaining investment?Following the reported activity, the director maintains a direct interest in 824,918 shares. This position was valued at $3.32 million as of the July 17, 2026 market close. The stock has generated a 3% return over the past 12 months as of the transaction date. What are the fundamental financial metrics for MannKind?For the trailing twelve months, the company reported revenue of $360.8 million and a net loss of ($23.9 million). The firm is headquartered in Danbury and focuses on the U.S. biopharmaceutical market for rare lung conditions and endocrine treatments. MannKind Corporation develops and commercializes respiratory-delivered biopharmaceutical treatments, with its flagship product Afrezza, an inhaled insulin formulation designed to improve glycemic control in adults with diabetes, serving as the primary revenue driver. The company generates revenue through direct pharmaceutical sales of its approved products to healthcare providers and patients, leveraging its proprietary pulmonary delivery technology platform to differentiate its therapeutic offerings in the marketplace. MannKind targets endocrinologists, primary care physicians, and patients with diabetes and rare pulmonary conditions in the United States, positioning its products for both adult and pediatric patient populations. MannKind Corporation is a biopharmaceutical company with a market capitalization of $1.2 billion and TTM revenue of $360.8 million. The company's competitive differentiation derives from its innovative pulmonary delivery technology platform, which enables non-invasive administration of therapeutics for endocrine disorders and rare lung conditions. MannKind's strategic focus on respiratory-delivered treatments addresses significant unmet medical needs while positioning the company within the specialized biopharmaceutical sector. Of the 93,790 shares Binder actually received, he kept fewer than half. Taxes claimed about 24,000, and he sold another 52,485 through a plan set well before the vesting date, walking away with roughly $214,000 in proceeds. Directors often hold rather than harvest, so the split here is worth noting, even though a plan set months earlier means he wasn't really reacting to anything. Plus, he still owns 824,918 shares, which at $4.03 is worth about $3.3 million.More importantly for long-term investors, the award paid out at 83% of target because MannKind landed at the 41.5th percentile of its pharma and biotech peer index. That middling result reflects a rough few years, punctuated by February, when the stock fell nearly 40% in a day after United Therapeutics announced Tresmi. CEO Martine Rothblatt called it a "category killer," and it threatens the Tyvaso DPI inhaler that generated $32.7 million in MannKind royalties during the first quarter. It’ll be critical to watch how Tresmi shapes up in the coming quarters. The payments have made up MannKind's most lucrative revenue stream, and after a peer-lagging performance in the past several years, it’s clear the market has already had some skepticism priced in even without this looming uncertainty. Before you buy stock in MannKind, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and MannKind wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $371,842!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,244,783!* Now, it’s worth noting Stock Advisor’s total average return is 900% — a market-crushing outperformance compared to 207% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of July 20, 2026. Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends MannKind. The Motley Fool has a disclosure policy. What This MannKind Director Sale Signals With $32.7 Million in Quarterly Royalties Revenue Potentially at Risk was originally published by The Motley Fool
Investor releaseQuarter not tagged2026-05-08MannKind (MNKD) Is Up 25.4% After Mixed Q1 Results and Expanded United Therapeutics Partnership – What's Changed
Simply Wall St.
MannKind (MNKD) Is Up 25.4% After Mixed Q1 Results and Expanded United Therapeutics Partnership – What's Changed
MannKind Corporation reported past first-quarter 2026 results with revenue rising to US$90.17 million from US$78.35 million, but the company moved from a US$13.16 million net profit to a US$16.62 million net loss as expenses increased following the scPharmaceuticals acquisition. Alongside these mixed results, MannKind highlighted progress on Afrezza pediatrics, Furoscix ReadyFlow, and an expanded ralinepag DPI collaboration with United Therapeutics that could materially influence its future revenue mix and risk profile. Now we will examine how MannKind’s return to quarterly losses, despite higher revenue, affects its existing investment narrative and risk balance. We've uncovered the 12 dividend fortresses yielding 5%+ that don't just survive market storms, but thrive in them. To own MannKind today, you have to believe its inhaled drug platform and expanding specialty portfolio can offset dependence on Tyvaso DPI royalties and Afrezza. The Q1 2026 return to losses, despite higher revenue, reinforces that near term the key catalyst is the upcoming FDA decision on Afrezza pediatrics, while the biggest risk is that rising operating costs after the scPharmaceuticals deal keep MannKind structurally unprofitable. This quarter’s results do not appear to change that risk-reward framing in a material way. Against this backdrop, the expanded ralinepag DPI collaboration with United Therapeutics stands out. The extra US$5 million payment, potential US$35 million in milestones, and 10% royalties underscore how important partnered inhaled therapies could become in reshaping MannKind’s revenue mix away from a narrow product base. For investors watching the Afrezza pediatric and Furoscix ReadyFlow PDUFA dates, this added program highlights both the opportunity to diversify and the execution risk tied to a still concentrated pipeline. However, beneath the revenue growth, the step-up in expenses and renewed losses could be an early sign of the kind of sustained cash burn investors should be aware of... Read the full narrative on MannKind (it's free!) MannKind's narrative projects $544.8 million revenue and $62.0 million earnings by 2029. Uncover how MannKind's forecasts yield a $7.17 fair value, a 102% upside to its current price. Some of the lowest ranking analysts were already cautious, assuming only about 3.7% annual revenue growth to roughly US$389 million and no profitab…Read full documentShow less
MannKind Corporation reported past first-quarter 2026 results with revenue rising to US$90.17 million from US$78.35 million, but the company moved from a US$13.16 million net profit to a US$16.62 million net loss as expenses increased following the scPharmaceuticals acquisition. Alongside these mixed results, MannKind highlighted progress on Afrezza pediatrics, Furoscix ReadyFlow, and an expanded ralinepag DPI collaboration with United Therapeutics that could materially influence its future revenue mix and risk profile. Now we will examine how MannKind’s return to quarterly losses, despite higher revenue, affects its existing investment narrative and risk balance. We've uncovered the 12 dividend fortresses yielding 5%+ that don't just survive market storms, but thrive in them. To own MannKind today, you have to believe its inhaled drug platform and expanding specialty portfolio can offset dependence on Tyvaso DPI royalties and Afrezza. The Q1 2026 return to losses, despite higher revenue, reinforces that near term the key catalyst is the upcoming FDA decision on Afrezza pediatrics, while the biggest risk is that rising operating costs after the scPharmaceuticals deal keep MannKind structurally unprofitable. This quarter’s results do not appear to change that risk-reward framing in a material way. Against this backdrop, the expanded ralinepag DPI collaboration with United Therapeutics stands out. The extra US$5 million payment, potential US$35 million in milestones, and 10% royalties underscore how important partnered inhaled therapies could become in reshaping MannKind’s revenue mix away from a narrow product base. For investors watching the Afrezza pediatric and Furoscix ReadyFlow PDUFA dates, this added program highlights both the opportunity to diversify and the execution risk tied to a still concentrated pipeline. However, beneath the revenue growth, the step-up in expenses and renewed losses could be an early sign of the kind of sustained cash burn investors should be aware of... Read the full narrative on MannKind (it's free!) MannKind's narrative projects $544.8 million revenue and $62.0 million earnings by 2029. Uncover how MannKind's forecasts yield a $7.17 fair value, a 102% upside to its current price. Some of the lowest ranking analysts were already cautious, assuming only about 3.7% annual revenue growth to roughly US$389 million and no profitability in three years, so this fresh loss may push you to reconsider how much weight you give to concerns about high spending and cash burn compared with more upbeat views on Afrezza pediatrics and the broader inhaled portfolio. Explore 3 other fair value estimates on MannKind - why the stock might be worth over 2x more than the current price! Don't just follow the ticker - dig into the data and build a conviction that's truly your own. A great starting point for your MannKind research is our analysis highlighting 3 key rewards and 2 important warning signs that could impact your investment decision. Our free MannKind research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate MannKind's overall financial health at a glance. Opportunities like this don't last. These are today's most promising picks. Check them out now: Invest in the nuclear renaissance through our list of 91 elite nuclear energy infrastructure plays powering the global AI revolution. Outshine the giants: these 17 early-stage AI stocks could fund your retirement. Capitalize on the AI infrastructure supercycle with our selection of the 39 best 'picks and shovels' of the AI gold rush converting record-breaking demand into massive cash flow. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include MNKD. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2026-05-07MannKind: Q1 Earnings Snapshot
Associated Press
MannKind: Q1 Earnings Snapshot
DANBURY, Conn. (AP) — DANBURY, Conn. (AP) — MannKind Corp. (MNKD) on Wednesday reported a loss of $16.6 million in its first quarter. The Danbury, Connecticut-based company said it had a loss of 5 cents per share. The results did not meet Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 2 cents per share. The biopharmaceutical company posted revenue of $90.2 million in the period, which also did not meet Street forecasts. Three analysts surveyed by Zacks expected $103.7 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on MNKD at https://www.zacks.com/ap/MNKD

