MANNKIND CORP
For the period ended Jun 30, 2025. Filed Aug 6, 2025.
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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.
Jun 30, 2025 · Filed Aug 6, 2025
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 2025-03-31; filed 2025-05-08.
0000950170-25-066429
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-06.
0000950170-25-103535
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 60 previous paragraphs and 69 current paragraphs.
27 unchanged; 29 reworded; 12 added; 4 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 previous and 9 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 (12)
Current report
Three and six months ended June 30, 2025 and 2024
Current report
Gross revenue from sales of Afrezza increased by $3.4 million, or 7%, for the six months ended June 30, 2025 compared to the same period in the prior year, primarily driven by increased price and higher volume. The gross-to-net adjustment remained consistent at 34% of gross revenue, or $17.1 million, for the six months ended June 30, 2025 compared to $16.1 million, for the same period in the prior year. As a result, net revenue from sales of Afrezza increased by $2.5 million, or 8%, for the six months ended June 30, 2025 compared to the same period in the prior year.
Current report
Net revenue from collaborations and services increased by $1.4 million, or 3%, for the six months ended June 30, 2025 compared to the same period in the prior year. The increase in revenue was primarily attributable to an increase in revenue from the Amphastar co-promote agreement of $1.0 million and an increase in UT CSA revenue. The increase in UT CSA revenue was primarily due to increased product sold to UT, and was partially offset by a decrease in other contractual reimbursements of $2.9 million.
Current report
Commercial product gross profit increased by $2.7 million, or 18%, for the three months ended June 30, 2025 compared to the same period in the prior year, primarily due to an increase in revenue for Afrezza and a decrease in cost of goods sold of Afrezza driven by decreased costs associated with increased efficiencies in manufacturing activities in our Danbury, CT facility, partially offset by the quarterly capacity fee through our agreement with Amphastar.
Current report
Cost of revenue – collaborations and services remained consistent for the six months ended June 30, 2025 compared to the same period in the prior year. The increase in costs of sales associated with an increase in the number of blisters sold was offset by a decrease in cost per blister due to increased efficiencies in manufacturing activities in our Danbury, CT facility.
Current report
Research and development expenses increased by $1.9 million, or 16%, for the three months ended June 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 our Afrezza post-marketing 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.
Current report
Selling, general and administrative expenses increased by $7.5 million, or 31%, for the three months ended June 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 Afrezza promotional costs.
Current report
Loss on settlement of debt of $7.1 million for the three and six months ended June 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 report
Loss on available-for-sale securities for the three and six months ended June 30, 2024 was $1.6 million as a result of modification of the Thirona investment.
Current report
In August 2025, we entered into the Backstone Credit Facility, pursuant to which we made an additional borrowing of $75.0 million. See Note 16 -Subsequent Events for additional information.
Current report
During the six months ended June 30, 2025, we generated $2.6 million of cash from our operating activities. Cash used in operating activities consisted of net income of $13.8 million offset by non-cash adjustments of $30.6 million and a net decrease in cash flows from operating assets and liabilities of $41.8 million. Non-cash items primarily included stock-based compensation of $12.9 million, loss on foreign currency transactions of $7.9 million and interest on liability for sale of future royalties of $7.1 million. These charges were partially offset by the sold portion of royalty revenue of $6.1 million. The net decrease in cash flows from operating assets and liabilities was primarily due to an increase of $15.3 million in accounts receivable, decrease of $9.3 million in accrued expenses and other current liabilities and decrease of $7.1 million in deferred revenue.
Current report
During the six months ended June 30, 2024, we generated $10.5 million of cash from our operating activities. Cash used in operating activities consisted of net income of $8.6 million offset by non-cash adjustments of $26.5 million and a net decrease in cash flows from operating assets and liabilities of $24.6 million. Non-cash items primarily included stock-based compensation of $10.3 million and interest on liability for sale of future royalties of $8.6 million. These charges were partially offset by the sold portion of royalty revenue of $4.8 million. The net decrease in cash flows from operating assets and liabilities was primarily due to an increase of $8.9 million in accounts receivable, increase of $5.3 million in prepaid expenses and other current assets and a decrease of $5.3 million in deferred revenue.
Removed paragraphs (4)
Previous report
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 report
Not meaningful
Previous 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.
Previous report
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.
Reworded paragraphs (29)
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”). 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. 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
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.
Current wording
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 planning a global Phase 2 trial and we expect clinical trial site activation by year end 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. 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.
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. Ongoing changes in tariff policy 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 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.
Current wording
As of June 30, 2025, we had cash, cash equivalents and investments of $201.2 million, an accumulated deficit of $3.2 billion and a total stockholders’ deficit of $55.0 million. We had net income of $0.7 million and $13.8 million for the three and six months ended June 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 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 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.
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 trend in net sales of 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 months ended March 31, 2025 and 2024 (dollars in thousands):
Current wording
The following table provides a comparison of the revenue categories for the three and six months ended June 30, 2025 and 2024 (dollars in thousands):
Previous wording
Three months ended March 31, 2025 and 2024
Current wording
Afrezza— Gross revenue from sales of Afrezza increased by $1.1 million, or 4%, for the three months ended June 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 $8.8 million, for the three months ended June 30, 2025 compared to 37% of gross revenue, or $9.8 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 $2.0 million, or 13%, for the three months ended June 30, 2025 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 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.
Current wording
V-Go — Gross revenue from sales of V-Go decreased by $2.9 million, or 30%, for the three months ended June 30, 2025 compared to the same period in the prior year and was a result of lower demand partially offset by increased price. The gross-to-net adjustment was 39% of gross revenue, or $2.6 million, for the three months ended June 30, 2025 compared to 53% of gross revenue, or $5.1 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 $0.4 million, or 8%, for the three months ended June 30, 2025 compared to the same period in the prior year.
Previous 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.
Current wording
Collaborations and Services — Net revenue from collaborations and services decreased by $3.2 million, or 12%, for the three months ended June 30, 2025 compared to the same period in the prior year. The decrease in revenue was primarily attributable to decreased collaboration and service revenue from UT of $3.8 million driven by a decrease in revenue from product sold to UT of $2.7 million and a decrease in the recognition of deferred revenue of $1.0 million due to the net impact of one-time items. Royalty revenue from UT increased by $5.6 million, or 22%, for three months ended June 30, 2025 and $13.0 million, or 27%, for the six months ended June 30, 2025 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 months ended March 31, 2025 and 2024 (dollars in thousands):
Current wording
The following table provides a comparison of the commercial product gross profit categories for the three and six months ended June 30, 2025 and 2024 (dollars in thousands):
Previous wording
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 wording
Commercial product gross profit increased by $2.9 million, or 10%, for the six months ended June 30, 2025 compared to the same period in the prior year, primarily due to an increase in revenue for Afrezza and lower cost of goods sold for V-Go, which was driven by lower production and sales volumes.
Previous wording
The following table provides a comparison of the expense categories for the three months ended March 31, 2025 and 2024 (dollars in thousands):
Current wording
The following table provides a comparison of the expense categories for the three and six months ended June 30, 2025 and 2024 (dollars in thousands):
Previous wording
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 wording
Cost of revenue – collaborations and services increased by $1.2 million, or 8%, for the three months ended June 30, 2025 compared to the same period in the prior year. The increase was primarily attributable to an increase in production related write-offs for the period.
Previous wording
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 wording
Research and development expenses increased by $2.9 million, or 13%, for the six months ended June 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 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.
Current wording
Selling, general and administrative expenses increased by $10.2 million, or 22%, for the six months ended June 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. 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 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.
Current wording
Loss on foreign currency transaction was $5.4 million for the three months ended June 30, 2025 compared to a gain of $0.5 million for the same period in the prior year and a loss of $7.9 million for the six months ended June 30, 2025 compared to a gain of $1.9 million for the same period in the prior year. This was 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.
Previous 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):
Current wording
The following table provides a comparison of the other income (expense) categories for the three and six months ended June 30, 2025 and 2024 (dollars in thousands):
Previous 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.
Current wording
Interest income, net, consisting of interest and accretion on investments net of amortization, decreased by $1.3 million for the three months ended June 30, 2025 compared to the same period in the prior year and $2.8 million for the six months ended June 30, 2025 compared to the same period in the prior year. This was primarily due to a lower average balance on our securities portfolio and lower yields.
Previous wording
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 wording
Interest expense decreased by $5.8 million for the three months ended June 30, 2025 compared to the same period in the prior year and $3.7 million for the six months ended June 30, 2025 compared to the same period in the prior year. The decrease in interest was 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.
Previous 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.
Current wording
Interest expense on liability for sale of future royalties decreased by $0.9 million and decreased by $1.6 million for the three and six months ended June 30, 2025 compared to the same periods in the prior year, respectively. 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 $2.4 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.
Current wording
Interest expense on financing liability was $2.4 million for the three months ended June 30, 2025 and 2024, and $4.8 million and $4.9 million for the six months ended June 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.
Previous 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.
Current wording
Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during the three and six months ended June 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 six months ended June 30, 2025 totaled $31.2 million and $61.2 million, respectively, of which $3.1 million and $6.1 million, respectively were remitted to the royalty purchaser.
Previous 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.
Current wording
As of June 30, 2025, we had $66.1 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. 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
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, $50.0 million of which remain payable as of March 31, 2025. See Note 14 –Commitments and Contingencies for further information related to the Milestone Rights.
Current 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 June 30, 2025. See Note 14 –Commitments and Contingencies for further information related to the Milestone Rights.
Previous 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.
Current wording
Cash provided by investing activities of $12.2 million for the six months ended June 30, 2025 was primarily due to the maturity of $101.8 million of debt securities, partially offset by the purchase of $88.1 million of debt securities.
Previous 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.
Current wording
Cash used in investing activities of $103.6 million for the six months ended June 30, 2024 was primarily due to the purchase of $187.4 million of debt securities and $5.4 million of property and equipment, partially offset by the maturity of $88.8 million of debt securities.
Previous 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.
Current wording
Cash used in financing activities of $4.1 million for the six months ended June 30, 2025 was primarily due to $4.4 million of payments to taxing authorities from equity withheld upon vesting of RSUs and stock options partially offset by $1.3 million in proceeds from our market price stock purchase plan and employee stock purchase plan.
Previous 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.
Current wording
Cash used in financing activities of $48.0 million for the six months ended June 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 $4.7 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 market price stock purchase plan and employee stock purchase plan.
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 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.
Current 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 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 June 30, 2025, we had capital resources comprised of cash, cash equivalents, short-term investments and long-term investments totaling $201.2 million, and total principal amount of outstanding borrowings of $36.3 million.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Gross revenue from sales of V-Go decreased by $5.7 million, or 30%, for the six months ended June 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 $5.0 million, for the six months ended June 30, 2025 compared to 53% of gross revenue, or $10.1 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 $0.6 million, or 7%, for the six months ended June 30, 2025 compared to the same period in the prior year.