MANNKIND CORP
For the period ended Mar 31, 2026. Filed May 6, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 6, 2026
MNKD$3.90+3.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-05.
0001193125-25-265813
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-06.
0001193125-26-208916
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 79 previous paragraphs and 70 current paragraphs.
20 unchanged; 30 reworded; 17 added; 28 removed; 1 previous and 3 current paragraphs rearranged.
Tables are not compared: 9 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (17)
Current report
We are 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, we aim to deliver therapies designed to fit seamlessly into daily life.
Current report
Furoscix is a novel formulation of furosemide that delivers an 80 mg dose via an on-body infusor over a five-hour period. Furoscix is approved by the U.S. Food and Drug Administration (or FDA) for the treatment of edema in pediatric patients who weigh at least 43 kg and adult patients with chronic heart failure or chronic kidney disease. Furoscix is the first FDA-approved subcutaneous loop diuretic that delivers intravenous-equivalent diuresis at home as opposed to a hospital setting. Furoscix was developed by scPharma, which we acquired in October 2025. See Note 2 –Business Combinations in the Consolidated Financial Statements included in Part II, Item 8 – Financial Statements and Supplementary Data.
Current report
We anticipate two potential milestones for our cardiometabolic business in 2026 based on regulatory submissions that we made in 2025. The FDA is currently reviewing a supplemental biologics license application (or sBLA) pursuant to which we are seeking approval for Afrezza in children and adolescents living with type 1 or type 2 diabetes. The sBLA has been assigned a PDUFA target action date of May 29, 2026. The FDA is also reviewing a supplemental new drug application (or sNDA) pursuant to which we are seeking approval for Furoscix ReadyFlow Autoinjector, a high-concentration formulation of furosemide that is delivered subcutaneously in under ten seconds. The sNDA has been assigned a PDUFA target action date of July 26, 2026.
Current report
In the United States, we are solely responsible for the commercialization of Afrezza, Furoscix and V-Go. Outside of the U.S., our strategy has been to establish regional partnerships in foreign jurisdictions where there are commercial opportunities, subject to the receipt of necessary foreign regulatory approvals. In December 2025, we supplied our partner in India, Cipla, with an initial shipment of Afrezza to support their launch of Afrezza in India. We expect to supply Cipla with additional product in accordance with the annual purchase commitments in our supply agreement.
Current report
The proprietary formulation and inhaler technologies used in Afrezza have also been deployed in our efforts to develop products to treat orphan lung diseases. Our first product to address an orphan lung disease, Tyvaso DPI (treprostinil) inhalation powder, received FDA approval in May 2022 for the treatment of pulmonary arterial hypertension (or PAH) and pulmonary hypertension associated with interstitial lung disease (or PH-ILD). Our development and marketing partner, United Therapeutics, began commercializing Tyvaso DPI in June 2022 and is obligated to pay us a royalty on net sales of the product. We also receive revenue for the supply of Tyvaso DPI that we manufacture for UT. In August 2025, we announced the expansion of our collaboration, pursuant to which we will formulate ralinepag (MNKD-1501) as a dry powder using our proprietary technologies. United Therapeutics will conduct preclinical and clinical development activities of MNKD-1501. Per the agreement, we received an upfront payment and are eligible to receive milestone payments upon achievement of specified development milestones as well as royalties on net sales of MNKD-1501, if approved.
Current report
The other major program in our pipeline that will potentially address an orphan lung disease is MNKD-201, a dry-powder formulation of nintedanib for the treatment of idiopathic pulmonary fibrosis (or IPF). An oral dosage form of nintedanib has been available for more than a decade. However, a fairly large oral dose is required in order to achieve sufficient drug levels in lung tissue. High systemic levels of nintedanib are often associated with undesirable side effects. Our goal with an inhaled formulation is to deliver a therapeutic amount of nintedanib to the lungs while avoiding high levels of the drug in other tissues. In 2024, we conducted a Phase 1 clinical study of MNKD-201, which met its primary objective of demonstrating positive safety results and good tolerability in healthy volunteers. We are currently conducting a Phase 1b study of MNKD-201 in the United States, with top line data expected in the third quarter of 2026, as well as a global Phase 2 study to assess the potential safety and efficacy of this investigational product in patients with IPF, in which we expect the first patient to be enrolled in the second quarter of 2026.
Current report
MNKD-701 is another pipeline opportunity that we are exploring. This program is focused on bumetanide, a more potent loop diuretic than furosemide. We are currently evaluating the feasibility of formulating bumetanide as a dry-powder that can be administered via oral inhalation.
Current report
Furoscix— Gross revenue from sales of Furoscix was $20.9 million for the three months ended March 31, 2026. The gross-to-net adjustment was 26% of gross revenue, or $5.4 million, resulting in net revenue of $15.5 million for the three months ended March 31, 2026. There was no Furoscix revenue in the prior-year period as we did not own or commercialize Furoscix until our acquisition of scPharma in October 2025.
Current report
Commercial product gross profit increased by $11.2 million, or 74%, for the three months ended March 31, 2026 compared to the same period in the prior year. The increase was primarily attributable to the increase in total product revenues after adding Furoscix to our product portfolio following the acquisition of scPharma in October 2025.
Current report
Cost of revenue – collaborations and services decreased by $3.8 million, or 28%, for the three months ended March 31, 2026 compared to the same period in the prior year. The decrease was primarily a result of decreased product sold to UT.
Current report
Research and development expenses increased by $6.2 million, or 56%, for the three months ended March 31, 2026 compared to the same period in the prior year. The increase was primarily attributable to higher personnel costs following the acquisition of scPharma and higher costs from development of MNKD-201 as studies advanced.
Current report
Selling, general and administrative expenses increased by $29.1 million, or 116%, for the three months ended March 31, 2026 compared to the same period in the prior year. The increase was primarily related to costs associated with the promotion and support of Furoscix, as well as higher Afrezza-related expenses including expanding the field based teams and preparing for a potential pediatric launch of Afrezza in 2026.
Current report
Amortization of acquired intangible assets was $4.4 million for the three months ended March 31, 2026 and was related to the amortization of the developed technology related to the Furoscix on-body infuser acquired from scPharma.
Current report
Interest expense increased by $2.8 million for the three months ended March 31, 2026 compared to the same period in the prior year. The increase was primarily due to new term loans with an aggregate principal amount of $325.0 million, which were drawn in August and October 2025.
Current report
Other expense of $2.8 million for the three months ended March 31, 2026 was the result of the remeasurement of the fair value of the contingent consideration liability obtained from the acquisition of scPharma. The contingent consideration will be remeasured each subsequent reporting period until the related contingencies have been resolved.
Current report
Cash provided by investing activities of $18.7 million for the three months ended March 31, 2026 was primarily due to $30.9 million of proceeds from maturities of available-for-sale securities. Cash provided was partially offset by the purchase of $10.3 million of available-for-sale securities as well as $1.9 million of property and equipment.
Current report
Cash used in financing activities of $35.4 million for the three months ended March 31, 2026 was primarily due to payments made to settle our remaining senior convertible notes.
Removed paragraphs (28)
Previous report
Our pipeline of potential treatments for orphan lung diseases includes inhaled clofazimine (MNKD-101) for the treatment of severe chronic and recurrent pulmonary infections, including nontuberculous mycobacterial ("NTM") lung disease. The FDA has designated inhaled clofazimine as both an orphan drug and as a qualified infectious disease product for the treatment of pulmonary NTM infections. It has also granted Fast Track designation to our development program. In 2024, we initiated a global Phase 3 registrational study of inhaled clofazimine with sites in the United States, Japan, South Korea, Taiwan, and Australia. We expect enrollment of subjects into this study to continue into 2026. The other major program in our pipeline is a dry-powder formulation of nintedanib (MNKD-201) for the treatment of idiopathic pulmonary fibrosis ("IPF"). In 2024, we conducted a Phase 1 clinical study of MNKD-201, which met its primary objective of demonstrating positive safety results and good tolerability in healthy volunteers. We are currently initiating a global Phase 2 trial that is expected to begin enrolling patients in early 2026.
Previous report
In October 2025, we acquired scPharmaceuticals Inc. ("scPharma") whose approved product, Furoscix, consists of a novel formulation of furosemide delivered via scPharma’s device supplier-developed on-body infusor, which delivers an 80 mg/10 mL dose over five hours. Furoscix was approved by the FDA for the treatment of congestion due to fluid overload in adults with New York Heart Association (“NYHA”) Class II/III and IV chronic heart failure. The commercial launch of Furoscix for congestion in patients with chronic heart failure commenced in the first quarter of 2023. In March 2025, Furoscix was also approved by the FDA for the treatment of edema due to fluid overload in adult patients with chronic kidney disease ("CKD") and launched in April 2025.
Previous report
As of September 30, 2025, we had cash, cash equivalents and investments of $286.3 million, an accumulated deficit of $3.2 billion and a total stockholders’ deficit of $44.6 million. We had net income of $8.0 million and $21.8 million for the three and nine months ended September 30, 2025, respectively. To date, we have funded our operations primarily through the sale of our equity and convertible debt securities, from the receipt of upfront and milestone payments from collaborations, from borrowings, from sales of
Previous report
Afrezza and V-Go, from royalties and manufacturing revenue from UT, from proceeds of the sale-leaseback of our manufacturing facility in Danbury, CT and from the sale of a portion of future royalties that we receive from UT.
Previous report
Three and nine months ended September 30, 2025 and 2024
Previous report
Gross revenue from sales of Afrezza increased by $6.4 million, or 9%, for the nine months ended September 30, 2025 compared to the same period in the prior year, primarily driven by increased price and higher demand. The gross-to-net adjustment was 32% of gross revenue, or $24.8 million, for the nine months ended September 30, 2025 compared to 35% of gross revenue, or $24.4 million, for the same period in the prior year. The decreased gross-to-net percentage was primarily attributable to a decrease in rebates. As a result, net revenue from sales of Afrezza increased by $5.9 million, or 13%, for the nine months ended September 30, 2025 compared to the same period in the prior year.
Previous report
Gross revenue from sales of V-Go decreased by $8.5 million, or 30%, for the nine months ended September 30, 2025 compared to the same period in the prior year and was primarily a result of lower demand partially offset by increased price. The gross-to-net adjustment was 38% of gross revenue, or $7.3 million, for the nine months ended September 30, 2025 compared to 51% of gross revenue, or $14.3 million, for the same period in the prior year. The improved gross-to-net percentage was primarily attributable to a decrease in rebates related to a reduction in active contracts. As a result, net revenue from sales of V-Go decreased by $1.5 million, or 11%, for the nine months ended September 30, 2025 compared to the same period in the prior year.
Previous report
Collaborations and Services — Net revenue from collaborations and services increased by $3.2 million, or 14%, for the three months ended September 30, 2025 compared to the same period in the prior year due to increases in revenue from our agreements with UT and Amphastar. The $2.7 million increase in revenue from UT was primarily attributable to an increase in revenue from product sold to UT of $3.4 million partially offset by decreases of $0.3 million in revenue from other agreements and $0.4 million related to the recognition of deferred revenue. The Amphastar co-promote agreement provided additional revenue of $0.5 million.
Previous report
Net revenue from collaborations and services increased by $4.6 million, or 6%, for the nine months ended September 30, 2025 compared to the same period in the prior year due to increases in revenue from our agreements with UT and Amphastar. The $3.3 million increase in revenue from UT was primarily attributable to an increase in revenue from product sold to UT of $4.3 million partially offset by decreases of $0.6 million in revenue from other agreements and $0.4 million related to the recognition of deferred revenue. The Amphastar co-promote agreement provided additional revenue of $1.5 million.
Previous report
Commercial product gross profit increased by $1.3 million, or 8%, for the three months ended September 30, 2025 compared to the same period in the prior year primarily due to an increase in revenue for Afrezza partially offset by an increase in cost of goods sold. Afrezza cost of goods sold increased primarily due to the quarterly capacity fee of $0.4 million associated with our Amphastar agreement which began in the first quarter of 2025. This increase was partially offset by increased efficiencies in manufacturing activities in our Danbury, CT facility.
Previous report
Commercial product gross profit increased by $4.2 million, or 9%, for the nine months ended September 30, 2025 compared to the same period in the prior year primarily due to an increase in revenue for Afrezza partially offset by a decrease in revenue for V-Go.
Previous report
Not meaningful
Previous report
Cost of revenue – collaborations and services increased by $0.9 million, or 6%, for the three months ended September 30, 2025 and $1.0 million, or 2%, for the nine months ended September 30, 2025 compared to the same periods in the prior year. The increases were primarily attributable to an increase in production related inventory write-offs for the period in addition to increase in costs of sales associated with an increase in the number of blisters sold, which was partially offset by decreases in cost per blister due to increased efficiencies in manufacturing activities in our Danbury, CT facility.
Previous report
Research and development expenses increased by $1.1 million, or 9%, for the three months ended September 30, 2025 compared to the same period in the prior year. The increase was primarily attributable to continued patient enrollment in our ICoN-1 clinical study for MNKD-101 and clinical production scale-up for MNKD-201. These increases were partially offset by the completion of our Afrezza clinical study (INHALE-3) and Phase 1 MNKD-201 studies in 2024, as well as lower costs for our Afrezza pediatric clinical study (INHALE-1) as the study was closed out in the second quarter of 2025.
Previous report
Research and development expenses increased by $4.0 million, or 12%, for the nine months ended September 30, 2025 compared to the same period in the prior year. The increase was primarily attributable to continued patient enrollment in our ICoN-1 clinical study for MNKD-101, clinical production scale-up for MNKD-201, and personnel costs primarily due to additional headcount as a result of the Pulmatrix transaction in the third quarter of 2024, which bolstered our research capabilities and capacity. These increases were partially offset by the completion of INHALE-3, the Phase 1 clinical study for MNKD-201, and toxicology studies in 2024, as well as lower costs for INHALE-1 as the study was closed out in the second quarter of 2025.
Previous report
Selling, general and administrative expenses increased by $5.2 million, or 22%, for the three months ended September 30, 2025 compared to the same period in the prior year. The increase was primarily driven by higher headcount and personnel-related costs including deploying a medical science liaison team and higher Afrezza promotional costs. Additionally, general and administrative expenses included $3.7 million of incremental costs associated with the acquisition of scPharma which was completed in October 2025. See Note 16– Subsequent Events.
Previous report
Selling, general and administrative expenses increased by $15.4 million, or 22%, for the nine months ended September 30, 2025 compared to the same period in the prior year. The increase was largely attributable to higher headcount and personnel-related expense as well as deploying a medical science liaison team and Afrezza promotional costs. Additionally, general and administrative expenses included $3.7 million of incremental costs associated with the acquisition of scPharma, which was completed in October 2025. These increases were partially offset by a $1.4 million charge recorded in the prior year period for estimated returns associated with sales of V-Go that pre-dated our acquisition of the product.
Previous report
Not meaningful
Previous report
Interest expense decreased by $0.4 million for the three months ended September 30, 2025 compared to the same period in the prior year due to a principal debt reduction from the exchange of an aggregate principal amount of approximately $193.7 million of our senior convertible notes due March 2026 in December 2024.
Previous report
Interest expense decreased by $4.1 million for the nine months ended September 30, 2025 compared to the same period in the prior year as a result of the following principal debt reductions that occurred in 2024: (i) $28.3 million full repayment to MidCap under the MidCap credit facility in April 2024, (ii) the discharge and termination of $8.8 million of the outstanding principal balance under the Mann Group convertible note in April 2024 and (iii) the exchange of an aggregate principal amount of approximately $193.7 million of our senior convertible notes due March 2026 in December 2024.
Previous report
Impairment of available-for-sale investment of $6.4 million for the three and nine months ended September 30, 2025 was a result of the write-off of the Thirona investment. Impairment of available-for-sale investment for the nine months ended September 30, 2024 was $1.6 million as a result of modification of the Thirona investment.
Previous report
Gain on bargain purchase of $5.3 million for the three and nine months ended September 30, 2024 was the result of the excess of net assets acquired over consideration paid in the Pulmatrix Transaction.
Previous report
Represents transaction fees incurred during the three and nine months ended September 30, 2025 associated with the acquisition of scPharma.
Previous report
As of September 30, 2025, we had $66.0 million in insulin purchase commitments and $111.3 million principal amount of outstanding debt, consisting of:
Previous report
$36.3 million principal amount of outstanding senior convertible notes bearing interest at 2.50% and maturing on March 1, 2026, unless earlier converted, redeemed or repurchased by us. The senior convertible notes are convertible at an initial conversion price of approximately $5.21 per share of common stock. The conversion rate is subject to adjustment under certain circumstances in accordance with the terms of the Indenture. We may from time to time seek to retire or purchase our outstanding senior convertible notes, through cash purchases and/or exchanges for equity securities, in open market purchases, privately negotiated transactions or otherwise. Such repurchases or exchanges, if any, will depend on prevailing market conditions, our liquidity requirements, contractual restrictions, and other factors. The amounts involved in any such transactions, individually or in the aggregate, may be material.
Previous report
In addition, in October 2025, we borrowed an additional $250.0 million in delayed draw term loans under the Blackstone Credit Facility to fund the acquisition of scPharma and the scPharma Debt Extinguishment (see Note 16 –Subsequent Events). Following this delayed draw, the SOFR Loans borrowed under the Blackstone Credit Facility will be subject to the Adjusted Term SOFR plus margin of 5.00% after the delivery of year-end financial statements.
Previous report
Cash used in investing activities of $12.8 million for the nine months ended September 30, 2025 was primarily due to the $10.0 million issuance of a note receivable and the purchase of $144.1 million of debt securities, partially offset by the maturity of $143.8 million of debt securities.
Previous report
Cash used in financing activities of $50.4 million for the nine months ended September 30, 2024 was primarily due to principal and early extinguishment payments on the MidCap credit facility of $36.6 million and Mann Group convertible note of $8.9 million, and $6.2 million of payments to taxing authorities from equity withheld upon vesting of RSUs and stock options, partially offset by $2.3 million in proceeds from the MPSPP and ESPP.
Reworded paragraphs (30)
Previous wording
We are a biopharmaceutical company focused on the development and commercialization of patient-centric therapies that address serious unmet medical needs for those living with cardiometabolic and orphan lung diseases. We currently commercialize two products: Afrezza (insulin human) Inhalation Powder, an ultra rapid-acting inhaled insulin indicated 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 that require insulin. Afrezza was developed by us and received approval from the FDA in June 2014. Afrezza consists of a dry powder formulation of human insulin delivered from a small portable inhaler. V-Go received 510(k) clearance by the FDA in 2010 and has been available commercially since 2012. In May 2022, we acquired V-Go from Zealand Pharma A/S and Zealand Pharma US, Inc. V-Go is a mechanical basal-bolus insulin delivery system that is worn like a patch and can eliminate the need for taking multiple daily injections. The first product to come out of our orphan lung disease pipeline, Tyvaso DPI (treprostinil) inhalation powder, received FDA approval in May 2022 for the treatment of PAH and PH-ILD. Our development and marketing partner, United Therapeutics, began commercializing Tyvaso DPI in June 2022 and is obligated to pay us a royalty on net sales of the product. We also receive a margin on supplies of Tyvaso DPI that we manufacture for UT.
Current wording
Our cardiometabolic business is currently comprised of three commercial products: Afrezza (insulin human) Inhalation Powder; Furoscix (furosemide injection); and the V-Go wearable insulin delivery device:
Previous wording
Our collaboration agreement with UT entitles us to receive a 10% royalty on net sales of Tyvaso DPI, subject to our sale of a 1% royalty on future net sales to a royalty purchaser (leaving us with a 9% royalty) in December 2023. Our royalty revenue reflects the trend in net sales of Tyvaso DPI in the marketplace. See Note 14 –Commitments and Contingencies in the condensed consolidated financial statements.
Current wording
Our collaboration agreement with UT entitles us to receive a 10% royalty on net sales of Tyvaso DPI, subject to our sale of a 1% royalty on future net sales to a royalty purchaser (leaving us with a 9% royalty). Our royalty revenue reflects trends in demand for Tyvaso DPI in the marketplace. See Note 15 –Commitments and Contingencies in the condensed consolidated financial statements.
Previous wording
Our future success is dependent on our, and our current and future collaboration partners’, ability to effectively commercialize approved products. Our future success is also dependent on our pipeline of new products. There is a high rate of failure inherent in the R&D process for new drugs. As a result, there is a high risk that the funds we invest in research programs will not generate sufficient financial returns. Products may appear promising in development but fail to reach market within the expected or optimal timeframe, or at all.
Current wording
Our future success is dependent on our, and our current and future collaboration partners’, ability to effectively commercialize approved products. Our future success is also dependent on our pipeline of new products and expansion opportunities for existing products, such as new formulations or expanded indications. There is a high rate of failure inherent in the R&D process for new drugs. As a result, there is a high risk that the funds we invest in research programs will not generate sufficient financial returns. Products may appear promising in development but fail to reach market within the expected or optimal timeframe, or at all.
Previous wording
The following table provides a comparison of the revenue categories for the three and nine months ended September 30, 2025 and 2024 (dollars in thousands):
Current wording
The following table provides a comparison of the revenue categories for the three months ended March 31, 2026 and 2025 (dollars in thousands):
Previous wording
Afrezza— Gross revenue from sales of Afrezza increased by $3.0 million, or 13%, for the three months ended September 30, 2025 compared to the same period in the prior year, primarily driven by increased price and higher demand. The gross-to-net adjustment was 30% of gross revenue, or $7.8 million, for the three months ended September 30, 2025 compared to 36% of gross revenue, or $8.3 million, for the same period in the prior year. The decreased gross-to-net percentage was primarily attributable to a decrease in rebates. As a result, net revenue from sales of Afrezza increased by $3.5 million, or 23%, for the three months ended September 30, 2025 compared to the same period in the prior year.
Current wording
Afrezza— Gross revenue from sales of Afrezza decreased by $1.1 million, or 5%, for the three months ended March 31, 2026 compared to the same period in the prior year. The decrease was driven primarily by lower demand. The gross-to-net adjustment was 31% of gross revenue, or $6.8 million, for the three months ended March 31, 2026 compared to 36% of gross revenue, or $8.3 million, for the same period in the prior year. The decreased gross-to-net percentage was primarily attributable to a decrease in government and commercial rebates in accordance with contractual arrangements. As a result, net revenue from sales of Afrezza increased by $0.4 million, or 3%, for the three months ended March 31, 2026 compared to the same period in the prior year.
Previous wording
V-Go — Gross revenue from sales of V-Go decreased by $2.8 million, or 31%, for the three months ended September 30, 2025 compared to the same period in the prior year as a result of lower demand partially offset by increased price. The gross-to-net adjustment was 38% of gross revenue, or $2.3 million, for the three months ended September 30, 2025 compared to 47% of gross revenue, or $4.2 million, for the same period in the prior year. The improved gross-to-net percentage was primarily attributable to a decrease in rebates related to implementation of a strategy to reduce active contracts. As a result, net revenue from sales of V-Go decreased by $0.9 million, or 19%, for the three months ended September 30, 2025 compared to the same period in the prior year.
Current wording
V-Go — Gross revenue from sales of V-Go decreased by $1.5 million, or 23%, for the three months ended March 31, 2026 compared to the same period in the prior year and was primarily a result of lower demand. The gross-to-net adjustment was 36% of gross revenue, or $1.8 million, for the three months ended March 31, 2026 compared to 36% of gross revenue, or $2.3 million, for the same period in the prior year. As a result, net revenue from sales of V-Go decreased by $0.9 million, or 23%, for the three months ended March 31, 2026 compared to the same period in the prior year.
Previous wording
Royalty revenue from UT increased by $6.2 million, or 23%, for the three months ended September 30, 2025 and $19.2 million, or 26%, for the nine months ended September 30, 2025 due to UT's increase in net revenue from sales of Tyvaso DPI.
Current wording
Collaborations and Services and Royalties— Net revenue from collaborations and services decreased by $5.9 million, or 20%, for the three months ended March 31, 2026 compared to the same period in the prior year. The decrease in revenue in the current quarter was primarily attributable to decreased product sold to UT due to timing of manufacturing activities and recognition of the related deferred revenue. Royalty revenue from UT increased by $2.7 million, or 9%, for the three months ended March 31, 2026 due to UT's increase in net revenue from sales of Tyvaso DPI.
Previous wording
The following table provides a comparison of the commercial product gross profit categories for the three and nine months ended September 30, 2025 and 2024 (dollars in thousands):
Current wording
The following table provides a comparison of the commercial product gross profit categories for the three months ended March 31, 2026 and 2025 (dollars in thousands):
Previous wording
The following table provides a comparison of the expense categories for the three and nine months ended September 30, 2025 and 2024 (dollars in thousands):
Current wording
The following table provides a comparison of the expense categories for the three months ended March 31, 2026 and 2025 (dollars in thousands):
Previous wording
Gain on foreign currency transaction was $0.1 million for the three months ended September 30, 2025 compared to a loss of $2.5 million for the same period in the prior year, and a loss of $7.8 million for the nine months ended September 30, 2025 compared to a loss of $0.5 million for the same period in the prior year. These non-cash changes were due to fluctuations in U.S. dollar to Euro exchange rates. Under the Insulin Supply Agreement with Amphastar, payment obligations for future purchases are denominated in Euros. We are required to record the foreign currency transaction impact of the U.S. dollar to Euro exchange rate associated with the recognized gain or loss on purchase commitments.
Current wording
Gain on foreign currency transaction was $1.3 million for the three months ended March 31, 2026 compared to a loss of $2.5 million for the same period in the prior year due to fluctuations in Euro to U.S. dollar exchange rates. Under the Insulin Supply Agreement with Amphastar, payment obligations for future purchases are denominated in Euros. We are required to record the foreign currency transaction impact of the U.S. dollar to Euro exchange rate associated with the recognized gain or loss on purchase commitments.
Previous wording
The following table provides a comparison of the other income (expense) categories for the three and nine months ended September 30, 2025 and 2024 (dollars in thousands):
Current wording
The following table provides a comparison of the other income (expense) categories for the three months ended March 31, 2026 and 2025 (dollars in thousands):
Previous wording
Interest income, net, consisting of interest and accretion on investments net of amortization, decreased by $0.6 million for the three months ended September 30, 2025 compared to the same period in the prior year, and by $3.4 million for the nine months ended
Current wording
Interest income, net, consisting of interest and accretion on investments net of amortization, decreased by $0.5 million for the three months ended March 31, 2026 compared to the same period in the prior year primarily due to a lower average balance on our securities portfolio and lower yields.
Previous wording
Interest expense on liability for sale of future royalties decreased by $0.6 million and $2.2 million for the three and nine months ended September 30, 2025, respectively, compared to the same periods in the prior year. Interest consists of imputed interest and the amortization of debt issuance costs on the liability recorded in connection with the sale of 1% of our Tyvaso DPI royalties in December 2023. See Note 14 –Commitments and Contingencies.
Current wording
Interest expense on liability for sale of future royalties decreased by $1.0 million for the three months ended March 31, 2026 compared to the same period in the prior year. Interest consists of imputed interest and the amortization of debt issuance costs on the liability recorded in connection with the sale of 1% of our Tyvaso DPI royalties in December 2023. Imputed interest is based on third-party estimates of future royalties to be generated from Tyvaso DPI. See Note 15 –Commitments and Contingencies.
Previous wording
Interest expense on financing liability was $2.5 million for each of the three months ended September 30, 2025 and 2024, and $7.3 million and $7.4 million for the nine months ended September 30, 2025 and 2024, respectively. Interest expense on financing liability represented interest incurred on the sale lease-back transaction for our manufacturing facility in Danbury, Connecticut.
Current wording
Interest expense on financing liability was $2.4 million for the three months ended March 31, 2026 and 2025, and represents interest incurred on the sale lease-back transaction for our manufacturing facility in Danbury, Connecticut.
Previous wording
Loss on settlement of debt of $7.1 million for the nine months ended September 30, 2024 was incurred in connection with the repayment of the MidCap credit facility and Mann Group convertible note in April 2024. See Note 8 –Borrowings.
Current wording
Loss on settlement of debt of $0.9 million for the three months ended March 31, 2026 was incurred in connection with the settlement of the senior convertible notes in March 2026.
Previous wording
To supplement our condensed consolidated financial statements presented under GAAP, we are presenting non-GAAP financial measures for net income and net income per share – basic. We are providing these non-GAAP financial measures, which are among the indicators management uses as a basis for evaluating our financial performance, to disclose additional information to facilitate the comparison of past and present operations. 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.
Current wording
To supplement our condensed consolidated financial statements presented under GAAP, we are presenting non-GAAP financial measures for net (loss) income and net (loss) income per share – basic. We are providing these non-GAAP financial measures, which are among the indicators management uses as a basis for evaluating our financial performance, to disclose additional information to facilitate the comparison of past and present operations. 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.
Previous wording
The following table reconciles our financial measures for net income and net income per share ("EPS") for basic weighted average shares as reported in our condensed consolidated statements of operations to a non-GAAP presentation as adjusted by certain non-cash items identified below.
Current wording
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 statements of operations to a non-GAAP presentation as adjusted by certain non-cash items identified below.
Previous wording
Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during the three and nine months ended September 30, 2025 and 2024, which is remitted to the royalty purchaser and recognized as royalties from collaborations in our condensed consolidated statements of operations. Our royalties from collaborations during the three and nine months ended September 30, 2025 totaled $33.3 million and $94.6 million, respectively, of which $3.3 million and $9.5 million, respectively were remitted to the royalty purchaser.
Current wording
Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during the three months ended March 31, 2026 and 2025, which is remitted to the royalty purchaser and recognized as royalties from collaborations in our condensed consolidated statements of operations. Our royalties from collaborations during the three months ended March 31, 2026 and 2025 totaled $32.7 million and $30.0 million, respectively, of which $3.3 million and $3.0 million, respectively were remitted to the royalty purchaser.
Previous wording
Our principal sources of liquidity are our cash, cash equivalents, and investments. Our primary uses of cash include development of our product pipeline, manufacturing and marketing of Afrezza and V-Go, manufacturing Tyvaso DPI, selling, general and administrative expenses, and principal and interest payments on our financing liability and debt.
Current wording
Our principal sources of liquidity are our cash, cash equivalents, and investments. Our primary uses of cash include development of our product pipeline, manufacturing and marketing of Afrezza, Furoscix and V-Go, manufacturing Tyvaso DPI, selling, general and administrative expenses, and principal and interest payments on our financing liability and debt.
Previous wording
Historically, we have funded our operations primarily through the sale of equity and convertible debt securities, from the receipt of upfront and milestone payments from collaborations, from borrowings, from the sale of certain assets and from the sale of a portion of our future royalties that we receive from UT. More recently, sales of Afrezza and V-Go, and royalties and manufacturing revenue from UT, have become a more significant source of funding for our operations. In combination with our cash, cash equivalents and investments on hand, we believe that these sources of revenue, as well as the potential financing sources currently available to us, will allow us to meet our liquidity needs over the next 12 months and in the longer term.
Current wording
We fund our operations primarily through sales of Afrezza, Furoscix and V-Go, and royalties, development and manufacturing revenue from UT. Historically, we have funded our operations primarily through the sale of equity and convertible debt securities, from the receipt of upfront and milestone payments from collaborations, from borrowings, from the sale of certain assets and from the sale of a portion of our future royalties that we receive from UT. In combination with our cash, cash equivalents and investments on hand, we believe that these sources of revenue will allow us to meet our liquidity needs over the next 12 months and in the longer term.
Previous wording
$75.0 million aggregate principal amount under the Blackstone Credit Facility. The Blackstone Credit Facility will mature on August 6, 2030. As of September 30, 2025, the term loans thereunder bore interest at a rate per annum equal to 9.00%. The interest rate is subject to fluctuation. We have the option to prepay the loans under the Blackstone Credit Facility in whole or in part, subject to early prepayment fees on or prior to the third anniversary of the Closing Date. See Note 8 –Borrowingsfor further information related to the Blackstone Credit Facility.
Current wording
As of March 31, 2026, we had $64.6 million in insulin purchase commitments and $325.0 million aggregate principal amount under the Blackstone Credit Facility. The Blackstone Credit Facility will mature on August 6, 2030. As of March 31, 2026, the effective interest rate is 9.09% per annum. The SOFR Loans borrowed under the Blackstone Credit Facility are subject to the Adjusted Term SOFR plus margin of 5.00%. We have the option to prepay the loans under the Blackstone Credit Facility in whole or in part, subject to early prepayment fees on or prior to the third anniversary of the Closing Date. See Note 9 –Borrowings for further information related to the Blackstone Credit Facility.
Previous wording
In July 2013, we issued the Milestone Rights pursuant to the Milestone Rights Agreement to the Original Milestone Purchasers. The Milestone Rights were subsequently assigned the Milestone Purchasers. The Milestone Rights provide the Milestone Purchasers certain rights to receive payments of up to $90.0 million upon the occurrence of specified strategic and sales milestones, $45.0 million of which remain payable as of September 30, 2025. See Note 14 –Commitments and Contingencies for further information related to the Milestone Rights.
Current wording
In July 2013, we granted Milestone Rights to the original purchasers under the Milestone Rights Agreement. The original purchasers later assigned those rights to new holders. As of March 31, 2026, $45.0 million remains payable upon the occurrence of specified strategic and sales milestones under the Milestone Rights Agreement. See Note 15 –Commitments and Contingencies for further information related to the Milestone Rights.
Previous wording
In February 2018, we entered into the CF Sales Agreement with Cantor Fitzgerald, as sales agent, which was amended and restated in February 2025. Under the CF Sales Agreement, Cantor Fitzgerald may sell shares of our common stock by any method deemed to be an “at-the-market offering” as defined in Rule 415 under the Securities Act of 1933, as amended. In February 2025, we filed a sales agreement prospectus under a registration statement on Form S-3 covering the sale of up to $200.0 million of our common stock through Cantor Fitzgerald under the CF Sales Agreement, of which $200.0 million remained available as of September 30, 2025.
Current wording
Pursuant to the CF Sales Agreement with Cantor Fitzgerald, we may offer and sell, from time to time, through Cantor Fitzgerald, shares of our common stock. Under the CF Sales Agreement, Cantor Fitzgerald may sell shares by any method deemed to be an “at-the-market offering” as defined in Rule 415 under the Securities Act of 1933, as amended. On February 26, 2025, we filed a sales agreement prospectus under a registration statement on Form S-3, which became effective upon filing, covering the sale of up to $200.0 million of our common stock through Cantor Fitzgerald under the CF Sales Agreement, of which $200.0 million remained available as of March 31, 2026.
Previous wording
During the nine months ended September 30, 2024, we generated $19.9 million of cash from our operating activities. Cash used in operating activities consisted of net income of $20.2 million offset by non-cash adjustments of $32.0 million and a net decrease in cash flows from operating assets and liabilities of $32.3 million. Non-cash items primarily included stock-based compensation of $15.5 million, loss on foreign currency transactions of $0.5 million and interest on liability for sale of future royalties of $12.7 million. These charges were partially offset by the sold portion of royalty revenue of $7.5 million and a gain on bargain purchase of $5.3 million. The decrease in cash flows from operating assets and liabilities was primarily due to a decrease of $7.2 million in deferred revenue, decrease of $6.4 million in prepaid expenses and other current assets and a decrease of $4.8 million in accrued expenses and other current liabilities.
Current wording
During the three months ended March 31, 2026, we used a net $5.4 million of cash for our operating activities. Cash used in operating activities consisted of net loss of $16.6 million offset by non-cash adjustments of $16.2 million and a net decrease in cash flow from operating assets and liabilities of $5.0 million. Non-cash items primarily included stock-based compensation of $6.5 million, depreciation and amortization of $6.4 million and change in fair value of contingent consideration of $2.8 million. These charges were partially offset by the sold portion of royalty revenue of $3.3 million and gain on foreign currency transactions of $1.3 million. The net decrease in cash flows from operating assets and liabilities was primarily due to an increase of $14.9 million in inventory, decrease of $5.8 million in accrued expenses and other current liabilities and decrease of $4.9 million in deferred revenue. The net decrease in cash flows from operating assets and liabilities was partially offset by a decrease of $10.3 million in accounts receivable.
Previous wording
During the nine months ended September 30, 2025, we generated $26.2 million of cash from our operating activities. Cash used in operating activities consisted of net income of $21.8 million offset by non-cash adjustments of $47.0 million and a net decrease in cash flows from operating assets and liabilities of $42.6 million. Non-cash items primarily included stock-based compensation of $17.2 million, loss on foreign currency transactions of $7.8 million and interest on liability for sale of future royalties of $10.6 million. These charges were partially offset by the sold portion of royalty revenue of $9.5 million. The net decrease in cash flows from operating assets and liabilities was primarily due to a decrease of $12.4 million in prepaid expenses and other current assets and a decrease of $10.1 million in accrued expenses and other current liabilities.
Current wording
During the three months ended March 31, 2025, we used a net $6.4 million of cash for our operating activities. Cash used in operating activities consisted of net income of $13.2 million offset by non-cash adjustments of $10.8 million and a net decrease in cash flows from operating assets and liabilities of $30.3 million. Non-cash items primarily included stock-based compensation of $5.4 million, depreciation and amortization of $2.1 million, and interest on liability for sale of future royalties of $3.6 million. These charges were partially offset by the sold portion of royalty revenue of $3.0 million. The net decrease in cash flows from operating assets and liabilities was primarily due to an increase of $17.1 million in accounts receivable, decrease of $4.5 million in deferred revenue and increase of $3.0 million in prepaid expenses and other current assets.
Previous wording
Cash used in investing activities of $144.9 million for the nine months ended September 30, 2024 was primarily due to the purchase of $273.8 million of debt securities and $6.8 million of property and equipment, partially offset by the maturity of $135.3 million of debt securities.
Current wording
Cash provided by investing activities of $6.0 million for the three months ended March 31, 2025 was primarily due to the maturity of $50.4 million of debt securities, partially offset by the purchase of $44.1 million of debt securities.
Previous wording
Cash provided by financing activities of $67.7 million for the nine months ended September 30, 2025 was primarily due to proceeds from a term loan of $75.0 million under the Blackstone Credit Facility, partially offset by $5.1 million of payments to taxing authorities from equity withheld upon vesting of RSUs and stock options and loan issuance costs of $2.3 million.
Current wording
Cash used in financing activities of $1.4 million for the three months ended March 31, 2025 was primarily due to $1.6 million of payments to taxing authorities from equity withheld upon vesting of RSUs and stock options.
Previous wording
We believe we will be able to meet our near-term liquidity needs based on our cash, cash equivalents and investments on hand, sales of Afrezza, V-Go and Furoscix, royalties and manufacturing revenue from the production and sale of Tyvaso DPI and borrowings under the Blackstone Credit Facility, as well as through debt or equity financing, if necessary, for our long-term liquidity needs. We expect to continue to incur expenditures for the foreseeable future in support of our manufacturing operations, sales and marketing costs for our products and development costs for other product candidates in our pipeline. As of September 30, 2025, we had capital resources comprised of cash, cash equivalents, short-term investments and long-term investments totaling $286.3 million, and total principal amount of outstanding borrowings of $111.3 million, which amounts do not take into account our completion of the scPharma acquisition in October 2025 and the scPharma Debt Extinguishment, and our additional $250.0 million term loan borrowing in October 2025 under the Blackstone Credit Facility in connection with such acquisition. See Note 16 –Subsequent Events.
Current wording
We believe that we will be able to meet our near-term liquidity needs based on our cash, cash equivalents and investments on hand, sales of Afrezza, Furoscix and V-Go, royalties and manufacturing revenue from the production and sale of Tyvaso DPI and, if necessary, borrowings under the Blackstone Credit Facility, as well as through debt or equity financing, for our long-term liquidity needs. We expect to continue to incur expenditures for the foreseeable future in support of our manufacturing operations, sales and marketing costs for our products and development costs for other product candidates in our pipeline. As of March 31, 2026, we had capital resources comprised of cash, cash equivalents and investments totaling $133.9 million, and total principal amount of outstanding borrowings of $325.0 million.
Previous wording
To date, we have been able to timely make our required interest payments, but we cannot guarantee that we will be able to do so in the future. If we fail to repay, repurchase or redeem, as applicable, our outstanding indebtedness and/or notes when required, we will be in default under the applicable instrument for such indebtedness and may also suffer an event of default under the terms of other borrowing arrangements that we may enter into from time to time. Any of these events could have a material adverse effect on our business, results of operations and financial condition, up to and including the noteholders initiating bankruptcy proceedings or causing us to cease operations altogether.
Current wording
To date, we have been able to timely make required interest payments under our outstanding indebtedness, but we cannot guarantee that we will be able to do so in the future. If we fail to repay our outstanding indebtedness when required, we will be in default under the applicable instrument for such indebtedness and may also suffer an event of default under the terms of other borrowing arrangements that we may enter into from time to time. Any of these events could have a material adverse effect on our business, results of operations and financial condition, up to and including the noteholders initiating bankruptcy proceedings or causing us to cease operations altogether.
Previous wording
See Note 8 –Borrowingsand Note 14 –Commitments and Contingencies for a discussion of material changes outside of the ordinary course of business in our contractual obligations from those disclosed within “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as contained in the Annual Report.
Current wording
There were no material changes outside of the ordinary course of business in our contractual obligations from those disclosed within “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as contained in our Annual Report on Form 10-K for the year ended December 31, 2025.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
Afrezza is an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes. Afrezza was developed by us and consists of a dry powder formulation of human insulin delivered from a small portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and delivers insulin quickly to the bloodstream.
Current report — wording carried from elsewhere
V-Go is a mechanical basal-bolus insulin delivery system that is worn like a patch and can eliminate the need for taking multiple daily injections. V-Go administers a continuous preset basal rate of insulin over 24 hours and provides discreet on-demand bolus dosing at mealtimes. V-Go received 510(k) clearance by the FDA in 2010 and has been available commercially since 2012. In May 2022, we acquired V-Go from Zealand Pharma US, Inc. and Zealand Pharma A/S.
Current report — wording carried from elsewhere
Three months ended March 31, 2026 and 2025
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
September 30, 2025 compared to the same period in the prior year. These decreases were primarily due to a lower average balance on our securities portfolio and lower yields.