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MANNKIND CORP

For the period ended Mar 31, 2025. Filed May 8, 2025.

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About this filing

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, 2025 · Filed May 8, 2025

MNKD$3.90+3.7%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-09-30; filed 2024-11-07.

0000950170-24-123296

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-03-31; filed 2025-05-08.

0000950170-25-066429

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 71 previous paragraphs and 60 current paragraphs.

21 unchanged; 31 reworded; 7 added; 19 removed; 0 previous and 1 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 (7)

Current report

Commercial product gross profit and gross margin remained consistent for the three months ended March 31, 2025 compared to the same period in the prior year. Cost of goods sold for Afrezza increased primarily as a result of higher sales volumes offset by lower cost of goods sold for V-Go, which was driven by lower production and sales volumes.

Current report

Cost of revenue – collaborations and services decreased by $1.0 million, or 7%, for the three months ended March 31, 2025 compared to the same period in the prior year. The decrease was primarily a result of producing Tyvaso DPI at volumes which result in efficiencies of scale at our Danbury, Connecticut facility.

Current report

Research and development expenses increased by $1.0 million, or 10%, for the three months ended March 31, 2025 compared to the same period in the prior year. The increase was primarily attributable to increased expenditures for development activities, including a Phase 3 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.

Current report

Interest expense increased by $2.1 million for the three months ended March 31, 2025 compared to the same period in the prior year. The increase was primarily attributed to the recognition of $4.4 million of interest expense related to our achievement of an Afrezza net sales milestone. See Note 14 –Commitments and Contingencies. The increase in interest expense was partially offset by a decrease in interest as a result of the following principal debt reductions that occurred in 2024: (i) the exchange of an aggregate principal amount of approximately $193.7 million of our senior convertible notes due March 2026 in December 2024, (ii) $28.3 million full repayment to MidCap under the MidCap credit facility in April 2024, and (iii) the discharge and termination of $8.8 million of the outstanding principal balance under the Mann Group convertible note in April 2024.

Current report

In addition to the above, we also expect to have material cash requirements relating to paying our employees and consultants, professional services fees, marketing expenses, manufacturing expenditures, and clinical trial expenses. In addition, we make substantial and often long-term investments in our supply chain in order to ensure we have enough inventory and drug product to meet current and future revenue forecasts, as well as clinical trial needs.

Current report

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 March 31, 2025.

Current report

During the three months ended March 31, 2025, we used $6.4 million of cash for our operating activities, which reflects our net income of $13.2 million increased by stock-based compensation of $5.4 million, offset by the sold portion of royalty revenue of $3.0 million and decreases for changes in operating assets and liabilities including a $17.1 million increase in accounts receivable and a decrease in liabilities for the recognition of $4.5 million in deferred revenue.
Removed paragraphs (19)

Previous report

We are conducting a Phase 3 clinical study, known as INHALE-1, evaluating the efficacy and safety of Afrezza in combination with basal insulin versus multiple daily injections of insulin in children and adolescents aged 4-17 who are living with type 1 or type 2 diabetes. A primary endpoint analysis for INHALE-1 is expected in the fourth quarter of 2024, with full results expected in the first half of 2025 and a planned FDA submission for a label expansion in 2025.

Previous report

The next most advanced program in our pipeline is MNKD-201, a dry-powder formulation of nintedanib, for the treatment of idiopathic pulmonary fibrosis ("IPF"). An oral dosage form of nintedanib was approved for IPF by the FDA in 2014. However, a fairly large oral dose is required in order to achieve sufficient drug levels in lung tissue. 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, where it is associated with undesirable side effects. Earlier this year, we conducted a first-in-human Phase 1 study of MNKD-201 for pulmonary fibrotic diseases, including IPF. A data readout is expected in the fourth quarter of 2024.

Previous report

Gross revenue from sales of Afrezza increased by $6.4 million, or 10%, for the nine months ended September 30, 2024 compared to the same period in the prior year. The increase was driven by higher demand and price. The gross-to-net adjustment was 35% of gross revenue, or $24.4 million, for the nine months ended September 30, 2024 compared to 38% of gross revenue, or $24.3 million, for the same period in the prior year. The improved gross-to-net percentage was primarily attributable to a decrease in anticipated product returns (as a percentage of gross sales). As a result, net revenue from sales of Afrezza increased by $6.3 million, or 16%, for the nine months ended September 30, 2024 compared to the same period in the prior year.

Previous report

Gross revenue from sales of V-Go decreased by $4.2 million, or 13%, for the nine months ended September 30, 2024 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 51% of gross revenue, or $14.3 million, for the nine months ended September 30, 2024 compared to 55% of gross revenue, or $17.6 million, for the same period in the prior year. The improved gross-to-net percentage was primarily attributable to a decrease in rebates. As a result, net revenue from sales of V-Go decreased by $0.9 million, or 6%, for the nine months ended September 30, 2024 compared to the same period in the prior year.

Previous report

Net revenue from collaborations and services increased by $38.4 million, or 108%, for the nine months ended September 30, 2024 compared to the same period in the prior year. The increase in revenue was primarily attributable to increased manufacturing volume for product sold to UT. Royalty revenue from UT increased by $24.4 million, or 48%, for the nine months ended September 30, 2024 due to UT's increase in net revenue from sales of Tyvaso DPI. See Note 10 –Collaboration, Licensing and Other Arrangements.

Previous report

Commercial product gross profit increased by $2.6 million, or 19%, for the three months ended September 30, 2024 compared to the same period in the prior year and $7.6 million, or 19%, for the nine months ended September 30, 2024 compared to the same period in the prior year. The increase in gross profit and gross margin was primarily attributable to an increase in Afrezza net revenue and improved gross-to-net adjustments related to V-Go rebates.

Previous report

Cost of revenue – collaborations and services increased by $4.6 million, or 45%, for the three months ended September 30, 2024 compared to the same period in the prior year and $14.4 million, or 48%, for the nine months ended September 30, 2024 compared to the same period in the prior year. The increases were primarily attributable to increased manufacturing volume for Tyvaso DPI.

Previous report

R&D expenses increased by $2.9 million, or 29%, for the three months ended September 30, 2024 and $12.7 million, or 58%, for the nine months ended September 30, 2024 compared to the same periods in the prior year. The increases were primarily attributable to increased expenditures for development activities and a Phase 3 clinical study of clofazimine inhaled suspension (MNKD-101), a Phase 1 clinical study of a dry-powder formulation of nintedanib (MNKD-201) for treatment of pulmonary fibrotic diseases, and personnel costs due to increased headcount as a result of the Pulmatrix Transaction.

Previous report

Selling expenses decreased by $0.3 million, or 3%, for the three months ended September 30, 2024 compared to the same period in the prior year. The decrease was primarily attributable to reduced personnel related to sales force restructuring activities completed during the first quarter of 2024, partially offset by an increase in promotional activities.

Previous report

Selling expenses decreased by $4.6 million, or 11%, for the nine months ended September 30, 2024 compared to the same period in the prior year. The decrease was primarily attributable to reduced personnel expenses related to sales force restructuring activities completed during the first quarter of 2024.

Previous report

General and administrative expenses increased by $0.3 million, or 3%, for the three months ended September 30, 2024 compared to the same period in the prior year. The increase was primarily attributable to increases in personnel costs, partially offset by reduced consulting fees.

Previous report

Interest expense decreased by $1.0 million for the three months ended September 30, 2024 and $2.1 million for the nine months ended September 30, 2024 compared to the same periods in the prior year. The decrease was primarily due to repayment of the MidCap credit facility and Mann Group convertible note in April 2024. See Note 9 –Borrowings.

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. See Note 2 –Pulmatrix Transaction.

Previous report

Other income for the three and nine months ended September 30, 2023 consisted primarily of gains associated with foreign currency hedging transactions which were entered into to mitigate our exposure to foreign currency exchange risks associated with our insulin purchase obligation under the Insulin Supply Agreement.

Previous report

Loss on extinguishment 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 9 –Borrowings.

Previous report

Loss on available-for-sale securities for the nine months ended September 30, 2024 was $1.6 million as a result of modification of the Thirona investment. The gain on available-for-sale securities for the nine months ended September 30, 2023 was $0.9 million as a result of the change in fair value of the investment. See Note 3 –Investments.

Previous report

During the nine months ended September 30, 2023, we generated $12.4 million of cash from our operating activities, which consisted primarily of $167.3 million of revenue, partially offset by $60.4 million of cost of goods sold, $35.7 million of selling expenses, $25.4 million of general and administrative expenses, $20.8 million of R&D costs and $13.0 million of cash paid for interest.
Reworded paragraphs (31)

Previous wording

In our endocrine business unit, 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. (together, “Zealand”) and began integrating the product into our endocrine business unit. 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.

Current wording

In our endocrine business unit, 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. (together, “Zealand”). 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.

Previous wording

The lead program in our pipeline of potential treatments for orphan lung diseases is MNKD-101, a nebulized formulation of clofazimine, for the treatment of severe chronic and recurrent pulmonary infections, including nontuberculous mycobacterial (NTM) lung disease. We believe an orally inhaled formulation of clofazimine could potentially provide several clinical advantages over the current solid oral dosage form, including directly targeting the site of the infection while lowering the systemic exposure of patients to the drug. The FDA has granted MNKD-101 status as 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 June 2024, we initiated a Phase 3 clinical study to investigate the potential of MNKD-101 to treat NTM lung disease. We began enrolling patients into this study in the third quarter of 2024.

Current wording

Our pipeline of potential treatments for orphan lung diseases includes MNKD-101, a nebulized formulation of clofazimine, for the treatment of severe chronic and recurrent pulmonary infections, including nontuberculous mycobacterial ("NTM") lung disease. The FDA has designated MNKD-101 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 MNKD-101 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 MNKD-201, a dry-powder formulation of nintedanib, 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 pursuing a global trial and expect to continue to the next phase of development in the second half of 2025.

Previous wording

Our business is subject to significant risks, including but not limited to our ability to manufacture sufficient quantities of our products and Tyvaso DPI. Other significant risks also include the risk that our products may only achieve a limited degree of commercial success and the risks inherent in drug development, clinical trials and the regulatory approval process for our product candidates, which in some cases depends upon the efforts of our partners.

Current wording

Our business is subject to significant risks, including but not limited to our ability to manufacture sufficient quantities of our products and Tyvaso DPI. Other significant risks also include the risk that our products may only achieve a limited degree of commercial success and the risks inherent in drug development, clinical trials and the regulatory approval process for our product candidates, which in some cases depends upon the efforts of our partners. The recently enacted and proposed tariffs by the U.S. government may potentially raise the future cost to source the raw materials and components needed to manufacture our products. We are actively monitoring this situation and exploring strategies to mitigate the risks.

Previous wording

As of September 30, 2024, we had an accumulated deficit of $3.2 billion and a stockholders’ deficit of $209.9 million. We had net income of $11.6 million and $20.2 million for the three and nine months ended September 30, 2024, 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 Afrezza and V-Go, from royalties and manufacturing revenue from UT as well as 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.

Current wording

As of March 31, 2025, we had cash, cash equivalents and investments of $198.2 million, an accumulated deficit of $3.2 billion and a total stockholders’ deficit of $58.6 million. We had net income of $13.2 million and $10.6 million for the three months ended March 31, 2025 and 2024, 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 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 wording

Our collaboration agreement with UT entitles us to receive a 10% royalty on net sales of Tyvaso DPI, subject to the sale by us in December 2023 of a 1% royalty on future net sales to a royalty purchaser (leaving us with a 9% royalty). Our royalty revenue reflects the upward trend in demand for Tyvaso DPI in the marketplace. See Note 15 –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) in December 2023. Our royalty revenue reflects the upward trend in demand for Tyvaso DPI in the marketplace. See Note 14 –Commitments and Contingencies in the condensed consolidated financial statements.

Previous wording

The following table provides a comparison of the revenue categories for the three and nine months ended September 30, 2024 and 2023 (dollars in thousands):

Current wording

The following table provides a comparison of the revenue categories for the three months ended March 31, 2025 and 2024 (dollars in thousands):

Previous wording

Afrezza— Gross revenue from sales of Afrezza increased by $1.7 million, or 8%, for the three months ended September 30, 2024 compared to the same period in the prior year. The increase was driven by higher demand. The gross-to-net adjustment was 36% of gross revenue, or $8.3 million, for the three months ended September 30, 2024 compared to 38% of gross revenue, or $8.1 million, for the same period in the prior year. The improved gross-to-net percentage was primarily attributable to a decrease in anticipated product returns (as a percentage of gross sales). As a result, net revenue from sales of Afrezza increased by $1.6 million, or 12%, for the three months ended September 30, 2024 compared to the same period in the prior year.

Current wording

Afrezza— Gross revenue from sales of Afrezza increased by $2.4 million, or 11%, for the three months ended March 31, 2025 compared to the same period in the prior year. The increase was driven primarily by higher demand and price. The gross-to-net adjustment was 36% of gross revenue, or $8.3 million, for the three months ended March 31, 2025 compared to 31% of gross revenue, or $6.4 million, for the same period in the prior year. The increased gross-to-net percentage was primarily attributable to a decrease in anticipated product returns (as a percentage of gross sales) in the prior year period. As a result, net revenue from sales of Afrezza increased by $0.4 million, or 3%, for the three months ended March 31, 2025 compared to the same period in the prior year.

Previous wording

V-Go — Gross revenue from sales of V-Go decreased by $1.6 million, or 15%, for the three months ended September 30, 2024 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 47% of gross revenue, or $4.2 million, for the three months ended September 30, 2024 compared to 58% of gross revenue, or $6.1 million, for the same period in the prior year. The improved gross-to-net percentage was primarily attributable to a decrease in rebates. As a result, net revenue from sales of V-Go increased by $0.2 million, or 5%, for the three months ended September 30, 2024 compared to the same period in the prior year.

Current wording

V-Go — Gross revenue from sales of V-Go decreased by $2.8 million, or 30%, for the three months ended March 31, 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 36% of gross revenue, or $2.3 million, for the three months ended March 31, 2025 compared to 53% of gross revenue, or $4.9 million, for the same period in the prior year. The improved gross-to-net percentage was primarily attributable to a decrease in rebates primarily related to a reduction in active contracts. As a result of lower demand being partially offset by improved gross-to-net percentage, net revenue from sales of V-Go decreased by $0.2 million, or 6%, for the three months ended March 31, 2025 compared to the same period in the prior year.

Previous wording

Collaborations and Services — Net revenue from collaborations and services increased by $10.2 million, or 78%, for the three months ended September 30, 2024 compared to the same period in the prior year. The increase in revenue was primarily attributable to increased manufacturing volume for product sold to UT. Royalty revenue from UT increased by $6.9 million, or 34%, for the three months ended September 30, 2024 due to UT's increase in net revenue from sales of Tyvaso DPI. See Note 10 –Collaboration, Licensing and Other Arrangements.

Current wording

Collaborations and Services — Net revenue from collaborations and services increased by $4.5 million, or 18%, for the three months ended March 31, 2025 compared to the same period in the prior year. The increase in revenue was primarily attributable to increased product sold to UT. Royalty revenue from UT increased by $7.4 million, or 32%, for the three months ended March 31, 2025 due to UT's increase in net revenue from sales of Tyvaso DPI due to higher patient demand.

Previous wording

The following table provides a comparison of the commercial product gross profit categories for the three and nine months ended September 30, 2024 and 2023 (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, 2025 and 2024 (dollars in thousands):

Previous wording

The following table provides a comparison of the expense categories for the three and nine months ended September 30, 2024 and 2023 (dollars in thousands):

Current wording

The following table provides a comparison of the expense categories for the three months ended March 31, 2025 and 2024 (dollars in thousands):

Previous wording

General and administrative expenses increased by $1.1 million, or 3%, for the nine months ended September 30, 2024 compared to the same period in the prior year. The increase was primarily attributable to a loss of $1.4 million for estimated returns associated with sales of V-Go that pre-date our acquisition of the product and increases in personnel costs, partially offset by reduced consulting fees.

Current wording

Selling, general and administrative expenses increased by $2.7 million, or 12%, for the three months ended March 31, 2025 compared to the same period in the prior year. The increase was primarily attributable to increases in headcount and personnel-related costs and increases in Afrezza promotional costs, partially offset by a loss of $1.2 million in the prior year period for estimated returns associated with sales of V-Go that pre-dated our acquisition of the product.

Previous wording

Under the Insulin Supply Agreement, payment obligations 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. The foreign currency transaction loss was $2.5 million for the three months ended September 30, 2024 compared to a gain of $2.1 million for the same period in the prior year and a loss of $0.5 million for the nine months ended September 30, 2024 compared to a gain of $0.9 million for the same period in the prior year due to the conversion of Euro to U.S. dollar exchange rates.

Current wording

Loss on foreign currency transaction was $2.5 million for the three months ended March 31, 2025 compared to a gain of $1.4 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, 2024 and 2023 (dollars in thousands):

Current wording

The following table provides a comparison of the other income (expense) categories for the three months ended March 31, 2025 and 2024 (dollars in thousands):

Previous wording

Interest income, net, consisting of interest and accretion on investments net of amortization, increased by $1.6 million for the three months ended September 30, 2024 and $5.4 million for the nine months ended September 30, 2024 compared to the same periods in the prior year primarily due to an increase in the underlying investments from the proceeds of the sale of 1% of our Tyvaso DPI royalties in December 2023 and higher yields on our securities portfolio.

Current wording

Interest income, net, consisting of interest and accretion on investments net of amortization, decreased by $1.5 million for the three months ended March 31, 2025 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 was $4.1 million and $12.7 million for the three and nine months ended September 30, 2024, respectively, and was attributable to imputed interest and 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 15 –Commitments and Contingencies.

Current wording

Interest expense on liability for sale of future royalties decreased by $0.7 million for the three months ended March 31, 2025 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. See Note 14 –Commitments and Contingencies.

Previous wording

Interest expense on financing liability was $2.5 million for each of the three months ended September 30, 2024 and 2023, and $7.4 million and $7.3 million for the nine months ended September 30, 2024 and 2023, respectively, and represented interest incurred on the sale lease-back transaction for our manufacturing facility in Danbury, CT.

Current wording

Interest expense on financing liability was $2.4 million for the three months ended March 31, 2025 and 2024, and represented interest incurred on the sale lease-back transaction for our manufacturing facility in Danbury, Connecticut.

Previous wording

To supplement our condensed consolidated financial statements presented under GAAP, we are presenting non-GAAP net income (loss) and non-GAAP net income (loss) per share – diluted, 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.

Current 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.

Previous wording

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 future cease 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 its 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 Quarterly Report on Form 10-Q 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.

Current wording

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 cease 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 its 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 Quarterly Report on Form 10-Q 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.

Previous wording

The following table reconciles our financial measures for net income (loss) and net income (loss) per share ("EPS") for diluted weighted average shares as reported in our condensed consolidated statements of operations to a non-GAAP presentation.

Current 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.

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, 2024 which is remitted to the royalty purchaser by UT and recognized as royalties – collaboration in our condensed consolidated statements of operations. Our royalties – collaboration during the three and nine months ended September 30, 2024 totaled $27.1 million and $75.3 million, respectively, of which $2.7 million and $7.5 million, respectively, was non-cash revenue attributed 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, 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 months ended March 31, 2025 and 2024 totaled $30.0 million and $22.7 million, respectively, of which $3.0 million and $2.3 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 the development of our product pipeline, the manufacturing and marketing of Afrezza and V-Go, manufacturing Tyvaso DPI, the funding of 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 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 proceeds from the sale of certain assets and 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 twelve months and in the longer term.

Current 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.

Previous wording

As of September 30, 2024, we had $62.6 million in insulin purchase commitments and $230.0 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. With the repayment of the MidCap credit facility and the Mann Group convertible note in April 2024, our Senior convertible notes are our only remaining notes outstanding.

Current wording

As of March 31, 2025, we had $60.7 million in insulin purchase commitments and $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. With the repayment of the MidCap credit facility and the Mann Group convertible note in April 2024, our senior convertible notes are our only remaining notes outstanding. 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 wording

During the nine months ended September 30, 2024, we generated $19.9 million of cash from our operating activities, which consisted primarily of $189.3 million in cash receipts from customers (net primarily of $11.5 million of non-cash revenue that was previously deferred and $7.5 million of non-cash revenue for the 1% sold portion of our royalties), partially offset by $59.8 million of cost of goods sold, $35.5 million of selling expenses, $34.3 million of costs for research and development, $29.4 million of general and administrative expenses, and $9.0 million of net cash paid for interest.

Current wording

During the three months ended March 31, 2024, we generated $6.7 million of cash from our operating activities, which primarily consisted of $55.5 million in cash receipts from customers, in addition to non-cash revenue consisting of $3.5 million net recognition of revenue that was previously deferred and $2.3 million of revenue for the 1% sold portion of our royalties, partially offset by $16.8 million of cost of goods sold, $9.8 million of selling expenses, $7.8 million of costs for research and development, $6.7 million of general and administrative expenses, and $5.8 million of net cash paid for interest.

Previous wording

Cash provided by investing activities of $5.9 million for the nine months ended September 30, 2023 was primarily due to $92.6 million of proceeds received from the sales of debt securities, partially offset by the purchase of debt securities of $50.5 million and by $36.6 million for the purchase of property and equipment which was substantially paid for by UT as part of our facility expansion project to increase manufacturing capacity.

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 $44.0 million of debt securities.

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 used in investing activities of $48.4 million for the three months ended March 31, 2024 was primarily due to the purchase of $68.4 million of debt securities and $2.4 million of property and equipment, partially offset by the maturity of $22.0 million of debt securities.

Previous wording

Cash used in financing activities of $5.1 million for the nine months ended September 30, 2023 was primarily due to $10.2 million of payments to taxing authorities from equity withheld upon vesting of RSUs and stock options, and payments of $1.7 million on MidCap credit facility, partially offset by $6.9 million in proceeds from at-the-market offerings and $1.1 million in proceeds from market price and ESPP.

Current wording

Cash provided by 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

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.

Current wording

Cash used in financing activities of $3.5 million for the three months ended March 31, 2024 was primarily due to principal payments on the MidCap credit facility of $5.0 million partially offset by $1.4 million in proceeds from the MPSPP.

Previous wording

Although we have not generated net income or cash flows from operating activities on a consistent basis, 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 and V-Go, and royalties and manufacturing revenue from the production and sale of Tyvaso DPI 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, 2024, we had capital resources comprised of cash, cash equivalents, short-term investments and long-term investments totaling $268.4 million, and total principal amount of outstanding borrowings of $230.0 million.

Current wording

Although we have not generated net income or cash flows from operating activities on a consistent basis, 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 and V-Go, and royalties and manufacturing revenue from the production and sale of Tyvaso DPI 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 March 31, 2025, we had capital resources comprised of cash, cash equivalents, short-term investments and long-term investments totaling $198.2 million, and total principal amount of outstanding borrowings of $36.3 million.

Previous wording

We believe our resources will be sufficient to fund our operations for the next twelve months from the date of issuance of our condensed consolidated financial statements included in Part I – Financial Statements (Unaudited).

Current wording

We believe our resources will be sufficient to fund our operations for at least the next 12 months from the date of issuance of our condensed consolidated financial statements included in Part I – Financial Statements (Unaudited).
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

Three months ended March 31, 2025 and 2024