11/05/2025 | Press release | Distributed by Public on 11/05/2025 07:06
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Statements in this report that are not strictly historical in nature are "forward-looking statements" within the meaning of the federal securities laws made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would," and similar expressions intended to identify forward-looking statements, though not all forward-looking statements contain these identifying words. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth below in Part II, Item 1A Risk Factors and elsewhere in this Quarterly Report on Form 10-Q. The preceding interim condensed consolidated financial statements and this Management's Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the financial statements and related notes for the year ended December 31, 2024 and Management's Discussion and Analysis of Financial Condition and Results of Operations contained in the Annual Report. Readers are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they are made.
OVERVIEW
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.
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.
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.
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.
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
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.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Our critical accounting policies and estimates can be found in Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report. See Note 1 - Description of Business and Significant Accounting Policiesin the condensed consolidated financial statements included in Part I - Financial Statements (Unaudited) for descriptions of the new accounting policies and impact of adoption.
RESULTS OF OPERATIONS
Trends and Uncertainties
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 Contingenciesin the condensed consolidated financial statements.
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.
Three and nine months ended September 30, 2025 and 2024
Revenues
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):
|
Three Months Ended September 30, |
||||||||||||||||
|
2025 |
2024 |
$ Change |
% Change |
|||||||||||||
|
Revenues |
||||||||||||||||
|
Commercial product sales: |
||||||||||||||||
|
Gross revenue from product sales |
$ |
32,420 |
$ |
32,232 |
$ |
188 |
1 |
% |
||||||||
|
Less: Wholesaler distribution fees, rebates and |
10,115 |
12,504 |
$ |
(2,389 |
) |
(19 |
%) |
|||||||||
|
Net revenue from commercial product sales |
$ |
22,305 |
$ |
19,728 |
$ |
2,577 |
13 |
% |
||||||||
|
Gross-to-net revenue adjustment percentage |
31 |
% |
39 |
% |
||||||||||||
|
Collaborations and services |
26,506 |
23,268 |
$ |
3,238 |
14 |
% |
||||||||||
|
Royalties |
33,319 |
27,083 |
$ |
6,236 |
23 |
% |
||||||||||
|
Total revenues |
$ |
82,130 |
$ |
70,079 |
$ |
12,051 |
17 |
% |
||||||||
|
Nine Months Ended September 30, |
||||||||||||||||
|
2025 |
2024 |
$ Change |
% Change |
|||||||||||||
|
Revenues |
||||||||||||||||
|
Commercial product sales: |
||||||||||||||||
|
Gross revenue from commercial product sales |
$ |
95,894 |
$ |
97,953 |
$ |
(2,059 |
) |
(2 |
%) |
|||||||
|
Less: Wholesaler distribution fees, rebates and |
32,162 |
38,681 |
$ |
(6,519 |
) |
(17 |
%) |
|||||||||
|
Commercial product sales |
$ |
63,732 |
$ |
59,272 |
$ |
4,460 |
8 |
% |
||||||||
|
Gross-to-net revenue adjustment percentage |
34 |
% |
39 |
% |
||||||||||||
|
Collaborations and services |
78,727 |
74,130 |
$ |
4,597 |
6 |
% |
||||||||||
|
Royalties |
94,552 |
75,326 |
$ |
19,226 |
26 |
% |
||||||||||
|
Total revenues |
$ |
237,011 |
$ |
208,728 |
$ |
28,283 |
14 |
% |
||||||||
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.
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.
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.
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.
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.
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.
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.
Commercial product gross profit
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):
|
Three Months Ended September 30, |
||||||||||||||||
|
2025 |
2024 |
$ Change |
% Change |
|||||||||||||
|
Commercial product gross profit: |
||||||||||||||||
|
Commercial product sales |
$ |
22,305 |
$ |
19,728 |
$ |
2,577 |
13 |
% |
||||||||
|
Less: Cost of goods sold |
4,498 |
3,197 |
$ |
1,301 |
41 |
% |
||||||||||
|
Commercial product gross profit: |
$ |
17,807 |
$ |
16,531 |
$ |
1,276 |
8 |
% |
||||||||
|
Gross margin |
80 |
% |
84 |
% |
||||||||||||
|
Nine Months Ended September 30, |
||||||||||||||||
|
2025 |
2024 |
$ Change |
% Change |
|||||||||||||
|
Commercial product gross profit: |
||||||||||||||||
|
Commercial product sales |
$ |
63,732 |
$ |
59,272 |
$ |
4,460 |
8 |
% |
||||||||
|
Less: Cost of goods sold |
12,873 |
12,621 |
$ |
252 |
2 |
% |
||||||||||
|
Commercial product gross profit: |
$ |
50,859 |
$ |
46,651 |
$ |
4,208 |
9 |
% |
||||||||
|
Gross margin |
80 |
% |
79 |
% |
||||||||||||
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.
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.
Expenses
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):
|
Three Months |
||||||||||||||||
|
2025 |
2024 |
$ Change |
% Change |
|||||||||||||
|
Expenses: |
||||||||||||||||
|
Cost of goods sold - commercial |
$ |
4,498 |
$ |
3,197 |
$ |
1,301 |
41 |
% |
||||||||
|
Cost of revenue - collaborations and services |
15,705 |
14,826 |
$ |
879 |
6 |
% |
||||||||||
|
Research and development |
14,063 |
12,926 |
$ |
1,137 |
9 |
% |
||||||||||
|
Selling, general and administrative |
29,088 |
23,916 |
$ |
5,172 |
22 |
% |
||||||||||
|
(Gain) loss on foreign currency transaction |
(120 |
) |
2,454 |
$ |
(2,574 |
) |
* |
|||||||||
|
Total expenses |
$ |
63,234 |
$ |
57,319 |
$ |
5,915 |
10 |
% |
||||||||
_________________________
* Not meaningful
|
Nine Months |
||||||||||||||||
|
2025 |
2024 |
$ Change |
% Change |
|||||||||||||
|
Expenses: |
||||||||||||||||
|
Cost of goods sold - commercial |
$ |
12,873 |
$ |
12,621 |
$ |
252 |
2 |
% |
||||||||
|
Cost of revenue - collaborations and services |
45,414 |
44,377 |
$ |
1,037 |
2 |
% |
||||||||||
|
Research and development |
38,760 |
34,755 |
$ |
4,005 |
12 |
% |
||||||||||
|
Selling, general and administrative |
85,724 |
70,357 |
$ |
15,367 |
22 |
% |
||||||||||
|
Loss on foreign currency transaction |
7,752 |
526 |
$ |
7,226 |
1,374 |
% |
||||||||||
|
Total expenses |
$ |
190,523 |
$ |
162,636 |
$ |
27,887 |
17 |
% |
||||||||
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.
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.
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.
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.
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.
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.
Other Income (Expense)
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):
|
Three Months |
||||||||||||||||
|
2025 |
2024 |
$ Change |
% Change |
|||||||||||||
|
Interest income, net |
$ |
2,628 |
$ |
3,179 |
$ |
(551 |
) |
(17 |
%) |
|||||||
|
Interest expense |
(1,364 |
) |
(1,801 |
) |
$ |
(437 |
) |
(24 |
%) |
|||||||
|
Interest expense on liability for sale of future royalties |
(3,514 |
) |
(4,089 |
) |
$ |
(575 |
) |
(14 |
%) |
|||||||
|
Interest expense on financing liability |
(2,456 |
) |
(2,470 |
) |
$ |
(14 |
) |
(1 |
%) |
|||||||
|
Impairment of available-for-sale investment |
(6,409 |
) |
- |
$ |
6,409 |
100 |
% |
|||||||||
|
Other income |
- |
32 |
$ |
32 |
(100 |
%) |
||||||||||
|
Gain on bargain purchase |
- |
5,259 |
$ |
(5,259 |
) |
(100 |
%) |
|||||||||
|
Total other (expense) income |
$ |
(11,115 |
) |
$ |
110 |
$ |
11,225 |
* |
||||||||
_________________________
* Not meaningful
|
Nine Months |
||||||||||||||||
|
2025 |
2024 |
$ Change |
% Change |
|||||||||||||
|
Interest income, net |
$ |
6,416 |
$ |
9,790 |
$ |
(3,374 |
) |
(34 |
%) |
|||||||
|
Interest expense |
(6,294 |
) |
(10,419 |
) |
$ |
(4,125 |
) |
(40 |
%) |
|||||||
|
Interest expense on liability for sale of future royalties |
(10,564 |
) |
(12,720 |
) |
$ |
(2,156 |
) |
(17 |
%) |
|||||||
|
Interest expense on financing liability |
(7,299 |
) |
(7,361 |
) |
$ |
(62 |
) |
(1 |
%) |
|||||||
|
Impairment of available-for-sale investment |
(6,409 |
) |
(1,550 |
) |
$ |
(4,859 |
) |
313 |
% |
|||||||
|
Other income |
- |
32 |
$ |
(32 |
) |
(100 |
%) |
|||||||||
|
Gain on bargain purchase |
- |
5,259 |
$ |
(5,259 |
) |
(100 |
%) |
|||||||||
|
Loss on settlement of debt |
- |
(7,050 |
) |
$ |
7,050 |
100 |
% |
|||||||||
|
Total other expense |
$ |
(24,150 |
) |
$ |
(24,019 |
) |
$ |
131 |
1 |
% |
||||||
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
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.
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.
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.
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.
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.
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.
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.
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.
Non-GAAP Measures
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.
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.
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.
|
Three Months |
Nine Months |
||||||||||||||||||||||||||||||
|
2025 |
2024 |
2025 |
2024 |
||||||||||||||||||||||||||||
|
Net Income |
Basic EPS |
Net Income |
Basic EPS |
Net Income |
Basic EPS |
Net Income |
Basic EPS |
||||||||||||||||||||||||
|
(In thousands except per share data) |
|||||||||||||||||||||||||||||||
|
GAAP reported net income |
$ |
7,985 |
$ |
0.03 |
$ |
11,550 |
$ |
0.04 |
$ |
21,811 |
$ |
0.07 |
$ |
20,166 |
$ |
0.07 |
|||||||||||||||
|
Non-GAAP adjustments: |
|||||||||||||||||||||||||||||||
|
Sold portion of royalty revenue (1) |
(3,332 |
) |
(0.01 |
) |
(2,708 |
) |
(0.01 |
) |
(9,455 |
) |
(0.03 |
) |
(7,533 |
) |
(0.03 |
) |
|||||||||||||||
|
Interest expense on liability for sale of future royalties |
3,514 |
0.01 |
4,089 |
0.02 |
10,564 |
0.03 |
12,720 |
0.04 |
|||||||||||||||||||||||
|
Acquisition related expenses (2) |
3,673 |
0.01 |
- |
- |
3,673 |
0.01 |
- |
- |
|||||||||||||||||||||||
|
Impairment loss on available-for-sale investment |
6,409 |
0.02 |
- |
- |
6,409 |
0.02 |
1,550 |
0.01 |
|||||||||||||||||||||||
|
Stock compensation |
4,318 |
0.01 |
5,227 |
0.02 |
17,223 |
0.06 |
15,540 |
0.06 |
|||||||||||||||||||||||
|
(Gain) loss on foreign currency transaction |
(120 |
) |
- |
2,454 |
0.01 |
7,752 |
0.03 |
526 |
- |
||||||||||||||||||||||
|
Gain on bargain purchase |
- |
- |
(5,259 |
) |
(0.02 |
) |
- |
- |
(5,259 |
) |
(0.02 |
) |
|||||||||||||||||||
|
Loss on settlement of debt |
- |
- |
- |
- |
- |
- |
7,050 |
0.03 |
|||||||||||||||||||||||
|
Non-GAAP adjusted net income |
$ |
22,447 |
$ |
0.07 |
$ |
15,353 |
$ |
0.06 |
$ |
57,977 |
$ |
0.19 |
$ |
44,760 |
$ |
0.16 |
|||||||||||||||
|
Weighted average shares used to compute net income |
306,806 |
274,998 |
305,093 |
272,811 |
|||||||||||||||||||||||||||
_________________________
LIQUIDITY AND CAPITAL RESOURCES
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.
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.
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:
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.
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.
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 Contingenciesfor further information related to the Milestone Rights.
In October 2025, we entered into the CVR Agreement with the rights agent party thereto, which governs the terms of the CVRs issued to the former stockholders of scPharma in the acquisition transaction. The maximum aggregate amount payable with respect to the CVRs issued at the closing of the acquisition is $59.7 million, subject to the achievement of certain regulatory and net sales milestones on or prior to the applicable milestone outside dates in accordance with the CVR Agreement.
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.
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.
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.
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.
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.
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.
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.
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.
Future Liquidity Needs
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.
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).
Contractual Obligations
See Note 8 - Borrowings and Note 14 - Commitments and Contingenciesfor 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.