Liquidia Corp
For the period ended Sep 30, 2026. Filed Nov 10, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 10, 2026
LQDA$51.40+7.4%Stored close · as of Nov 10, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-12.
0001104659-26-094410
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-10.
0001104659-26-124752
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 92 previous paragraphs and 113 current paragraphs.
45 unchanged; 40 reworded; 24 added; 6 removed; 1 previous and 4 current paragraphs rearranged.
Tables are not compared: 12 previous and 11 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 (24)
Current report
Recent Events
Current report
Settlement Agreement
Current report
On October 13, 2026, we entered into the Settlement Agreement with UTC resolving, without admission of liability by either party, all ongoing litigation between us and UTC, including the resolution of the ‘327 Patent Litigation, the ‘782 Patent Litigation, the Trade Secret Litigation, the Breach of Contract Litigation, the ‘494 Patent Litigation, and the RareGen Litigation, each as defined and discussed inNote 14 Legal Proceedings. The Settlement Agreement followed the September 30, 2026 decision of the U.S. District Court for the District of Delaware in the ‘327 Patent Litigation, and, as part of the Settlement Agreement, we agreed not to appeal that decision.
Current report
Under the terms of the Settlement Agreement, we will continue to market, sell and promote YUTREPIA for the treatment of PAH. In exchange, we (a) filed a supplement with the FDA to amend the current product label of YUTREPIA to remove PH-ILD as an indicated treatment as well as any reference to PH-ILD, (b) immediately and permanently ceased any and all activities relating to the marketing, advertising, promotion, and detailing of YUTREPIA for the treatment of PH-ILD, and (c) agreed to pay UTC (i) $185.0 million within thirty business days of October 13, 2026 and (ii) an aggregate of $145.4 million, to be paid in two equal installments of $72.7 million on or before January 31, 2027 and April 30, 2027, respectively (such payments, collectively, the “UTC Payments”). UTC agreed to pay us $10.0 million within thirty business days of October 13, 2026 in resolution of the RareGen Litigation. On October 19, 2026, we paid UTC the $185.0 million initial payment, and we received the $10.0 million payment from UTC on October 16, 2026. The Settlement Agreement does not grant us a license to UTC’s patents. To secure the UTC Payments, on October 23, 2026, we caused irrevocable standby letters of credit to be issued in the aggregate amount of $145.4 million in favor of UTC (seeNote 16 Subsequent Events).
Current report
Under the Settlement Agreement, we were required to secure a settlement of the antitrust and breach of contract proceedings brought by Sandoz and Liquidia PAH against UTC and Smiths Medical ASD, Inc. in the RareGen Litigation, as further discussed inNote 14 Legal Proceedings. Accordingly, we entered into agreements with each of Sandoz, Henderson SPV, LLC (“Henderson”) and PBM RG Holdings, LLC (“PBM”), which held interests in the RareGen Litigation. The amounts payable under these agreements were determined as part of the negotiation of the Settlement Agreement and do not reflect arm's-length price discovery for the value of the RareGen Litigation.
Current report
Sandoz Agreement
Current report
On October 11, 2026, we entered into a Settlement and Termination Agreement with Sandoz (the “Sandoz Agreement”) to settle Sandoz’s entitlement to fifty percent of the proceeds from the RareGen Litigation pursuant to the Promotion Agreement. Under the Sandoz Agreement, Liquidia made a payment of $21.75 million (the “Sandoz Payment”) into escrow on October 14, 2026, which amount will be released to Sandoz upon Sandoz’s delivery into escrow of the documents necessary to dismiss the RareGen Litigation with prejudice and the entry by the Company and/or its affiliates into the Settlement Agreement. Upon release of the Sandoz Payment to Sandoz, Sandoz’s interest in the RareGen Litigation is assigned to us and the Promotion Agreement terminates, other than Sandoz’s obligation to pay net profits for the third quarter of 2026 and provisions that survive termination. The Sandoz Payment was released to Sandoz on October 26, 2026.
Current report
Henderson Agreement
Current report
On October 8, 2026, we entered into a Settlement and Termination Agreement with Henderson (the “Henderson Agreement”), which fixed the amount payable to Henderson in complete satisfaction of its economic rights under the
Current report
Litigation Financing Agreement, dated as of June 4, 2020, by and between Henderson and RareGen, pursuant to which Henderson funded a portion of Liquidia PAH’s legal and litigation expenses in the RareGen Litigation in exchange for a share of certain litigation or settlement proceeds (the “Financing Agreement”). Under the Henderson Agreement, we paid Henderson $19.05 million on October 16, 2026, which included repayment of the $8.5 million litigation finance payable, and the Financing Agreement terminated upon that payment.
Current report
PBM Agreement
Current report
On October 10, 2026, we entered into a Settlement and Termination Agreement with PBM (the “PBM Agreement”), which fixed the amount payable to PBM in complete satisfaction of its economic rights under the Litigation Funding and Indemnification Agreement, dated as of November 17, 2020 (the “Indemnification Agreement”), by and between PBM and RareGen, under which PBM controls the RareGen Litigation, reimburses Liquidia PAH’s litigation expenses not reimbursed by Henderson and was entitled to the proceeds of the RareGen Litigation to which Henderson is not entitled. Under the PBM Agreement, we paid PBM $19.45 million on October 16, 2026, and the Indemnification Agreement, including our right to indemnification under it, terminated upon that payment. However, PBM will continue to reimburse Liquidia PAH’s residual RareGen Litigation expenses.
Current report
PBM is a related party of the Company because it is controlled by Paul B. Manning, a stockholder of the Company who beneficially owns at least 5% of our outstanding common stock and is also a member of our Board of Directors (the “Board”), and it is also owned by Roger A. Jeffs, Ph.D., our Chief Executive Officer and a member of the Board, Damian deGoa, a member of the Board, and Russell Schundler, our General Counsel. The PBM Agreement was reviewed and approved by the disinterested members of the Board.
Current report
Seventh Amendment to Revenue Interest Financing Agreement
Current report
On October 13, 2026, we entered into a Seventh Amendment (the “Seventh Amendment”) to the revenue interest financing agreement with HealthCare Royalty Partners IV, L.P. (“HCR”) dated January 9, 2023, as amended (the “HCR Agreement”), pursuant to which HCR consented to the letters of credit issued in favor of UTC in connection with the Settlement Agreement. As consideration for such consent, we agreed to increase the minimum cash covenant under the HCR Agreement from $15.0 million to $45.0 million. The Seventh Amendment involved no fees and did not change the payment terms of the HCR Agreement (seeNote 11 Long-term Debt).
Current report
Interest Expense, Net
Current report
not meaningful
Current report
Litigation Settlement, Net
Current report
Litigation settlement, net was $389.7 million for the three and nine months ended September 30, 2026 and reflects charges recorded for the settlement of our litigation with UTC and the related agreements with Sandoz, Henderson, and PBM, consisting of $330.4 million payable to UTC, less $10.0 million receivable from UTC, $60.3 million payable to Sandoz, Henderson and PBM (of which $8.5 million repaid the litigation finance payable and is not included in the charge), the $8.5 million write-off of the indemnification asset and $9.1 million of impairment losses on the contract acquisition costs and intangible asset related to the Promotion Agreement. SeeNote 14 Legal Proceedingsto the condensed consolidated financial statements for additional information.
Current report
Interest Expense, Net
Current report
Income Tax Benefit
Current report
On October 23, 2026, JPMorgan Chase Bank, N.A. issued irrevocable standby letters of credit in the aggregate amount of $145.4 million in favor of UTC for the account of Liquidia Technologies, Inc. to secure the UTC Payments. The letters of credit secure our recorded obligation to UTC and do not increase our total liabilities; a drawing by UTC would create a reimbursement obligation to the issuing bank in place of the corresponding amount payable to UTC. The letters of credit are partially cash collateralized and as of October 23, 2026, $105.4 million of cash and cash equivalents has been legally restricted until the UTC Payments have been made.
Current report
Litigation Settlement Obligations
Current report
Pursuant to the Settlement Agreement, Sandoz Agreement, PBM Agreement, and Henderson Agreement, we made payments totaling $245.25 million during October 2026 and are obligated to pay an additional $145.4 million in the aggregate, in two equal installments on or before January 31, 2027 and April 30, 2027. See Note 14Legal Proceedings to the condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q for further discussion of legal proceedings.
Removed paragraphs (6)
Previous report
Treprostinil Injection is a fully-substitutable generic treprostinil for parenteral administration in the United States. We have the exclusive rights to conduct commercial activities for Treprostinil Injection and work jointly with Sandoz on commercial strategy for the product. Sandoz retains all rights in and to Treprostinil Injection and holds the Abbreviated New Drug Application (“ANDA”) for Treprostinil Injection.
Previous report
Our future funding requirements will be heavily determined by whether we are able to successfully maintain FDA approval for and commercialize YUTREPIA and the resources needed to support further development of our products and product candidates. Based on current operating plans and excluding any additional external financing, we will have sufficient cash and cash equivalents to fund operating expenses and capital requirements and meet our minimum cash covenants beyond one year from the issuance of these condensed consolidated financial statements. We have based this estimate on assumptions that may prove to be wrong, and we could be limited in our ability to continue to commercialize YUTREPIA and/or we could utilize our available capital resources sooner than we currently expect, which would have a material impact on our operations.
Previous report
Other Income (Expense)
Previous report
Other Income (Expense)
Previous report
Income Tax Expense
Previous report
We from time-to-time are subject to claims and litigation in the normal course of business. See Note 14Legal Proceedings to the condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q for further discussion of pending legal proceedings.
Reworded paragraphs (40)
Previous wording
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations is intended to provide information necessary to understand our condensed consolidated financial statements and highlight certain other information which, in the opinion of management, will enhance a reader’s understanding of our financial condition, changes in financial condition, results of operations, and cash flows. In particular, the discussion is intended to provide an analysis of significant trends and material changes in our financial position and the operating results of our business during the three and six months ended June 30, 2026 as compared to the three and six months ended June 30, 2025. This discussion should be read in conjunction with our condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q as well as our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which includes detailed discussions of various items impacting our business, results of operations and financial condition.
Current wording
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations is intended to provide information necessary to understand our condensed consolidated financial statements and highlight certain other information which, in the opinion of management, will enhance a reader’s understanding of our financial condition, changes in financial condition, results of operations, and cash flows. In particular, the discussion is intended to provide an analysis of significant trends and material changes in our financial position and the operating results of our business during the three and nine months ended September 30, 2026 as compared to the three and nine months ended September 30, 2025. This discussion should be read in conjunction with our condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q as well as our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which includes detailed discussions of various items impacting our business, results of operations and financial condition.
Previous wording
We are a biopharmaceutical company driven by science and compassion to revolutionize care for patients with challenging respiratory and vascular diseases such as pulmonary arterial hypertension (“PAH”) and pulmonary hypertension associated with interstitial lung disease (“PH-ILD”). We operate through our wholly owned operating subsidiaries, Liquidia Technologies, Inc. and Liquidia PAH, LLC, formerly known as RareGen.
Current wording
We are a biopharmaceutical company driven by science and compassion to revolutionize care for patients with challenging respiratory and vascular diseases. We operate through our wholly owned operating subsidiaries, Liquidia Technologies, Inc. and Liquidia PAH, LLC, formerly known as RareGen.
Previous wording
YUTREPIA is an inhaled dry powder formulation of treprostinil designed with our proprietary PRINT technology, a particle engineering platform that enables precise production of uniform drug particles, to improve the therapeutic profile of treprostinil by enhancing deep lung delivery while using a convenient, low effort dry-powder inhaler (“DPI”) and by achieving higher dose levels than the labeled doses of other marketed inhaled treprostinil therapies. YUTREPIA was approved by the U.S. Food and Drug Administration (“FDA”) in May 2025 for the treatment of both PAH and PH-ILD, and began commercialization in June 2025.
Current wording
We currently generate product revenue through the sale of YUTREPIA® (treprostinil) inhalation powder (“YUTREPIA”). YUTREPIA is an inhaled dry powder formulation of treprostinil designed with our proprietary PRINT technology, a particle engineering platform that enables precise production of uniform drug particles, to improve the therapeutic profile of treprostinil by enhancing deep lung delivery while using a convenient, low effort dry-powder inhaler (“DPI”) and by achieving higher dose levels than the labeled doses of other marketed inhaled treprostinil therapies. YUTREPIA was approved by the U.S. Food and Drug Administration (“FDA”) in May 2025 for the treatment of pulmonary arterial hypertension (“PAH”) and pulmonary hypertension associated with interstitial lung disease (“PH-ILD”) and began commercialization in June 2025. In October 2026, we entered into a settlement agreement (“Settlement Agreement”) with United Therapeutics Corporation (“UTC”) settling all outstanding litigation between the parties and pursuant to which we agreed to cease promoting YUTREPIA for the treatment of PH-ILD and agreed to amend the label for YUTREPIA to remove PH-ILD.
Previous wording
We currently generate revenue through the sale of YUTREPIA (treprostinil) inhalation powder (“YUTREPIA”) and pursuant to a promotion agreement with Sandoz Inc. (“Sandoz”), dated as of August 1, 2018, as amended (the “Promotion Agreement”), under which we share profit derived from the sale of Sandoz’s generic treprostinil injection (“Treprostinil Injection”) in the United States.
Current wording
Through the third quarter of 2026, we also generated revenue pursuant to a promotion agreement with Sandoz Inc. (“Sandoz”), dated as of August 1, 2018, as amended (the “Promotion Agreement”), under which we shared profit derived from the sale of Sandoz’s generic treprostinil injection (“Treprostinil Injection”) in the United States. Treprostinil Injection is a fully substitutable generic treprostinil for parenteral administration in the United States. The Promotion Agreement was terminated in October 2026 and we will no longer generate service revenue.
Previous wording
We employ a targeted commercial field force calling on healthcare providers involved in the treatment of PAH and PH-ILD in the United States, as well as key stakeholders involved in the distribution and reimbursement of medicines to treat these patients.
Current wording
We employ a targeted commercial field force calling on healthcare providers involved in the treatment of PAH in the United States, as well as key stakeholders involved in the distribution and reimbursement of medicines to treat these patients.
Previous wording
daily with a short-duration next-generation nebulizer. L606 is currently being evaluated in an open-label study in the United States for treatment of PAH and PH-ILD and in a worldwide, placebo-controlled pivotal study for the treatment of PH-ILD. We are also planning to conduct clinical studies to evaluate YUTREPIA for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (“PH-COPD”), idiopathic pulmonary fibrosis (“IPF”), progressive pulmonary fibrosis (“PPF”) and Raynaud’s phenomenon associated with systemic sclerosis (“SSc-RP”).
Current wording
daily with a short-duration next-generation nebulizer. L606 is currently being evaluated in an open-label study in the United States for treatment of PAH and PH-ILD and in a worldwide, placebo-controlled pivotal study for the treatment of PH-ILD. In September 2026, we initiated a clinical study to evaluate YUTREPIA for the treatment of Raynaud’s phenomenon associated with systemic sclerosis (“SSc-RP”). We are also planning to conduct clinical studies in pulmonary hypertension associated with chronic obstructive pulmonary disease (“PH-COPD”), idiopathic pulmonary fibrosis (“IPF”), and progressive pulmonary fibrosis (“PPF”).
Previous wording
We began generating revenue from the sales of YUTREPIA in June 2025, following the FDA approval on May 23, 2025, for the treatment of PAH and PH-ILD. Revenues from product sales are recognized net of variable consideration due to rebates, chargebacks, trade discounts and allowances, sales returns, and other incentives. Provisions for estimated reductions to revenue are provided for in the same period the related sales are recorded and are based on contractual terms, actual utilization data, forecasted payor mix, total prescriptions and industry data. We expect product sales to increase if we are able to maintain FDA approval for YUTREPIA and gain market share.
Current wording
We have generated product revenue since June 2025, following the receipt of FDA approval of YUTREPIA in May 2025 for the treatment of PAH and PH-ILD. Revenues from product sales are recognized net of variable consideration due to rebates, chargebacks, trade discounts and allowances, sales returns, and other incentives. Provisions for estimated reductions to revenue are provided for in the same period the related sales are recorded and are based on contractual terms, actual utilization data, forecasted payor mix, total prescriptions and industry data. As a result of the Settlement Agreement, in October 2026, we permanently ceased any and all activities relating to the marketing, advertising, promotion, and detailing of YUTREPIA for the treatment of PH-ILD, and we have filed a supplement with the FDA to amend the current product label of YUTREPIA to remove PH-ILD as an indicated treatment. The commercial impact of this change remains uncertain, and product sales may be negatively impacted as a result.
Previous wording
We primarily generate service revenue pursuant to the Promotion Agreement, under which we receive a 50% share in the profit derived from the sale of Treprostinil Injection in the United States. Liquidia PAH has the exclusive rights to conduct commercial activities to encourage the appropriate use of Treprostinil Injection. To administer Treprostinil Injection through subcutaneous injection, patients currently must use the CADD-MS 3 infusion pump manufactured by ICU Medical. ICU Medical no longer manufactures or supports the CADD-MS 3 infusion pump. Although we believe that the number of available CADD-MS 3 infusion pumps will be sufficient to serve patients through at least the end of 2026, it is possible that the availability of CADD-MS 3 infusion pumps could end earlier. Due to this limitation in the availability of pumps, specialty pharmacies will limit the number of patients that they place on subcutaneous Treprostinil Injection therapy in order to ensure that patients placed on subcutaneous administration of Treprostinil Injection will not have to discontinue such treatment due to the unavailability of CADD-MS infusion pumps. Until we and/or Sandoz are able to obtain a pump to replace the CADD-MS 3 infusion pump, if ever, the number of patients that can receive subcutaneous administration of Treprostinil Injection will continue to be constrained. Revenue will continue to be impacted unless and until alternative pumps are available.
Current wording
We generated service revenue pursuant to the Promotion Agreement, under which we received a 50% share in the profit derived from the sale of Treprostinil Injection in the United States. Liquidia PAH had the exclusive rights to conduct commercial activities to encourage the appropriate use of Treprostinil Injection. The Promotion Agreement was terminated during the fourth quarter of 2026 and no further service revenue will be recognized related to the Promotion Agreement.
Previous wording
Cost of product sales includes direct and indirect costs related to the manufacturing of inventory products sold, including third-party manufacturing costs, packaging services, freight, storage costs, allocation of overhead costs of employees involved with manufacturing and net sales-based royalty expense. As of June 30, 2026, we have sold through all inventory previously expensed to research and development and accordingly, our future cost of product sales of will reflect the full cost of manufacturing YUTREPIA.
Current wording
Cost of product sales includes direct and indirect costs related to the manufacturing of inventory products sold, including third-party manufacturing costs, packaging services, freight, storage costs, allocation of overhead costs of employees involved with manufacturing and net sales-based royalty expense. As of September 30, 2026, we have sold through all inventory previously expensed to research and development and accordingly, our cost of product sales reflects the full cost of manufacturing YUTREPIA.
Previous wording
Cost of service revenue consists of (i) an allocation of the cost of our commercial field force associated with calling on healthcare providers involved in the treatment of PAH with Treprostinil Injection, as well as key stakeholders involved in the distribution and reimbursement of Treprostinil Injection and (ii) amortization of the intangible asset associated with the Promotion Agreement. We amortize the intangible asset associated with the Promotion Agreement in a manner consistent with our recognition of the related revenue.
Current wording
Cost of service revenue consists of (i) an allocation of the cost of our commercial field force associated with calling on healthcare providers involved in the treatment of PAH with Treprostinil Injection, as well as key stakeholders involved in the distribution and reimbursement of Treprostinil Injection and (ii) amortization of the intangible asset associated with the Promotion Agreement. We amortize the intangible asset associated with the Promotion Agreement in a manner consistent with our recognition of the related revenue. The Promotion Agreement was terminated during the fourth quarter of 2026 and no further cost of service revenue will be recognized related to the Promotion Agreement.
Previous wording
Other income (expense) is comprised of interest income and expense. Interest income consists of interest earned on our cash equivalents. Interest expense consists of non-cash interest charges on long-term debt.
Current wording
Interest expense, net consists of interest income earned on our cash equivalents and non-cash interest charges on long-term debt.
Previous wording
Comparison of the Three and Six Months Ended June 30, 2026 and 2025
Current wording
Comparison of the Three and Nine Months Ended September 30, 2026 and 2025
Previous wording
Product sales, net, were $170.4 million for the three months ended June 30, 2026, compared to $6.5 million for the three months ended June 30, 2025. We began shipping YUTREPIA to our customers in the United States in June 2025, following receipt of full FDA approval for YUTREPIA on May 23, 2025. The increase of $163.9 million was due to higher volume of YUTREPIA sales.
Current wording
Product sales, net, were $222.7 million for the three months ended September 30, 2026, compared to $51.7 million for the three months ended September 30, 2025. We began shipping YUTREPIA to our customers in the United States in June 2025, following receipt of full FDA approval for YUTREPIA on May 23, 2025. The increase of $171.0 million was due to higher volume of YUTREPIA sales.
Previous wording
Product sales, net, were $300.3 millionfor the six months ended June 30, 2026, compared to $6.5 million for the six months ended June 30, 2025. We began shipping YUTREPIA to our customers in the United States in June 2025, following receipt of full FDA approval for YUTREPIA on May 23, 2025. The increase of $293.8 million was due to higher volume of YUTREPIA sales.
Current wording
Product sales, net, were $523.0 millionfor the nine months ended September 30, 2026, compared to $58.2 million for the nine months ended September 30, 2025. We began shipping YUTREPIA to our customers in the United States in June
Previous wording
Service revenue, net, was $1.3 million for the three months ended June 30, 2026, compared to $2.3 million for the three months ended June 30, 2025. Service revenue, net was related primarily to the Promotion Agreement. The decrease of $1.0 million was primarily due to the impact of unfavorable gross-to-net adjustments.
Current wording
Service revenue, net, was $2.6 million for the three months ended September 30, 2026, compared to $2.7 million for the three months ended September 30, 2025. The decrease of $0.1 million was primarily due to the impact of unfavorable gross-to-net adjustments.
Previous wording
Service revenue, net, was $4.3 million for the six months ended June 30, 2026, compared to $5.4 million for the six months ended June 30, 2025. Service revenue, net was related primarily tothe Promotion Agreement. The decrease of $1.1 million was primarily due tothe impact of unfavorable gross-to-net adjustments.
Current wording
Service revenue, net, was $6.8 million for the nine months ended September 30, 2026, compared to $8.1 million for the nine months ended September 30, 2025. The decrease of $1.3 million was primarily due tothe impact of unfavorable gross-to-net adjustments.
Previous wording
Cost of product sales was $10.8 million for the three months ended June 30, 2026, compared to $0.2 million for the three months ended June 30, 2025. Cost of products sales is related to sales of YUTREPIA. The increase of $10.6 million was primarilydue to higher volume of YUTREPIA sales.
Current wording
Cost of product sales was $14.0 million for the three months ended September 30, 2026, compared to $2.3 million for the three months ended September 30, 2025. Cost of product sales is related to sales of YUTREPIA. The increase of $11.7 million was primarilydue to higher volume of YUTREPIA sales.
Previous wording
Cost of product sales was $21.8 million for the six months ended June 30, 2026, compared to $0.2 million for the six months ended June 30, 2025. Cost of products sales is related to sales of YUTREPIA. The increase of $21.6 million was primarily due tohigher volume of YUTREPIA sales.
Current wording
Cost of product sales was $35.8 million for the nine months ended September 30, 2026, compared to $2.5 million for the nine months ended September 30, 2025. Cost of product sales is related to sales of YUTREPIA. The increase of $33.3 million was primarily due tohigher volume of YUTREPIA sales.
Previous wording
Cost of service revenue was $0.8 million for the three months ended June 30, 2026, compared to $1.3 million for the three months ended June 30, 2025. The decrease from 2025 to 2026 reflects a lower allocation of the cost of our commercial field force to Treprostinil Injection resulting from the commercial launch of YUTREPIA in the second quarter of 2025.
Current wording
Cost of service revenue was $0.8 million for the three months ended September 30, 2026, compared to $0.9 million for the three months ended September 30, 2025. The decrease from 2025 to 2026 reflects a lower allocation of the cost of our commercial field force to Treprostinil Injection following the commercial launch of YUTREPIA in the second quarter of 2025.
Previous wording
Cost of service revenue was $1.6 million for the six months ended June 30, 2026, compared to $2.8 million for the six months ended June 30, 2025. The decrease from 2025 to 2026 reflects a lower allocation of the cost of our commercial field force to Treprostinil Injection resulting from the commercial launch of YUTREPIA in the second quarter of 2025.
Current wording
Cost of service revenue was $2.4 million for the nine months ended September 30, 2026, compared to $3.7 million for the nine months ended September 30, 2025. The decrease from 2025 to 2026 reflects a lower allocation of the cost of our commercial field force to Treprostinil Injection following the commercial launch of YUTREPIA in the second quarter of 2025.
Previous wording
Research and development expenses were $17.2 million for the three months ended June 30, 2026, compared to $6.0 million for the three months ended June 30, 2025. The increase of $11.2 million or 185% was primarily due to a $7.0 million increase in expenses for our L606 program, a $2.0 million increase in expenses related to our YUTREPIA research and development activities, $0.9 million increase in personnel expenses driven by higher headcount, and a $1.0 million L606 development milestone recognized during the second quarter of 2026.
Current wording
Research and development expenses were $25.3 million for the three months ended September 30, 2026, compared to $9.3 million for the three months ended September 30, 2025. The increase of $16.0 million or 170% was primarily due to an $11.1 million increase in expenses for our L606 program, a $3.2 million increase in expenses related to our YUTREPIA research and development activities, and a $1.2 million increase in personnel expenses driven by higher headcount.
Previous wording
Research and development expenses were $29.8 million for the six months ended June 30, 2026, compared to $13.0 million for the six months ended June 30, 2025. The increase of $16.8 million or 129% was primarily due to a $9.6 million increase in clinical expenses for our L606 program, a $3.8 million increase in expenses related to our YUTREPIA research and development activities, a $2.0 million increase in personnel expenses driven by higher headcount, and a $1.0 million L606 development milestone recognized during the second quarter of 2026.
Current wording
Research and development expenses were $55.0 million for the nine months ended September 30, 2026, compared to $22.3 million for the nine months ended September 30, 2025. The increase of $32.7 million or 146% was primarily due to a $20.7 million increase in clinical expenses for our L606 program, a $7.0 million increase in expenses related to our YUTREPIA research and development activities, a $3.2 million increase in personnel expenses driven by higher headcount, and a $1.0 million L606 development milestone recognized during the second quarter of 2026.
Previous wording
Selling, general and administrative expenses were $57.4 million for the three months ended June 30, 2026, compared to $38.8 million for the three months ended June 30, 2025. The increase of $18.6 million or 48% was primarily due to a $10.0 million increase in personnel expenses and a $3.1 million increase in stock-based compensation driven by higher headcount, and an $8.6 million increase in commercial and consulting expenses to support the commercialization of YUTREPIA. These increases were partially offset by a $5.5 million decrease in legal fees related to our ongoing YUTREPIA-related litigation.
Current wording
Selling, general and administrative expenses were $59.0 million for the three months ended September 30, 2026, compared to $40.1 million for the three months ended September 30, 2025. The increase of $18.9 million or 47% was primarily due to a $6.4 million increase in personnel expenses and a $5.5 million increase in stock-based compensation
Previous wording
Selling, general and administrative expenses were $104.4 million for the six months ended June 30, 2026, compared to $68.9 million for the six months ended June 30, 2025. The increase of $35.5 million or 52% was primarily due to a $18.6 million increase in personnel expenses and a $4.8 million increase in stock-based compensation driven by higher headcount, a $16.5 million increase in commercial and consulting expenses to support the commercialization of YUTREPIA, and a $1.2 million increase in facilities and infrastructure expenses. These increases were partially offset by a $9.1 million decrease in legal fees related to our ongoing YUTREPIA-related litigation.
Current wording
Selling, general and administrative expenses were $163.4 million for the nine months ended September 30, 2026, compared to $108.9 million for the nine months ended September 30, 2025. The increase of $54.5 million or 50% was primarily due to a $25.0 million increase in personnel expenses and a $10.3 million increase in stock-based compensation driven by higher headcount, a $20.6 million increase in commercial and consulting expenses to support the commercialization of YUTREPIA, and a $1.9 million increase in facilities and infrastructure expenses. These increases were partially offset by a $9.6 million decrease in legal fees related to our YUTREPIA-related litigation, which was settled in October 2026.
Previous wording
Total other expense, net was $8.5 million for the six months ended June 30, 2026, compared to $7.0 million for the six months ended June 30, 2025. The increase of $1.5 million was primarily attributable to higher borrowings under the HCR Agreement offset by higher money market balances.
Current wording
Interest expense, net was $2.9 million for the three months ended September 30, 2026, compared to $5.3 million for the three months ended September 30, 2025. The decrease of $2.4 million was primarily attributable to higher money market balances and lower interest accretion under the HCR Agreement.
Previous wording
Total other expense, net was $3.8 million for the three months ended June 30, 2026, compared to $4.1 million for the three months ended June 30, 2025. The decrease of $0.3 million was primarily attributable to higher money market balances offset by higher borrowings under the HCR Agreement.
Current wording
Interest expense, net was $11.4 million for the nine months ended September 30, 2026, compared to $12.3 million for the nine months ended September 30, 2025. The decrease of $0.9 million was primarily attributable to higher money market balances offset by higher interest accretion under the HCR Agreement.
Previous wording
Income tax expense was $7.0 million for the three months ended June 30, 2026. We did not recognize any income tax expense during the three months ended June 30, 2025.
Current wording
Income tax benefit was $30.1 million for the three months ended September 30, 2026. We did not recognize any income tax benefit during the three months ended September 30, 2025.
Previous wording
Income tax expense was $10.9 million for the six months ended June 30, 2026. We did not recognize any income tax expense during the six months ended June 30, 2025.
Current wording
Income tax benefit was $19.2 million for the nine months ended September 30, 2026. We did not recognize any income tax benefit during the nine months ended September 30, 2025.
Previous wording
We have financed our growth and operations through a combination of funds generated from revenues, the issuance of convertible preferred stock and common stock, bank borrowings, the issuance of convertible notes, and other long-term debt. Our principal uses of cash have been for working capital requirements and capital expenditures. As of June 30, 2026, we had cash and cash equivalents of $284.2 million, stockholders’ equity of $195.1 million, and an accumulated deficit of $498.7 million.
Current wording
We have financed our growth and operations through a combination of funds generated from revenues, the issuance of convertible preferred stock and common stock, bank borrowings, the issuance of convertible notes, and other long-term debt. Our principal uses of cash have been for working capital requirements and capital expenditures. As of September 30, 2026, we had cash and cash equivalents of $396.1 million, stockholders’ deficit of $25.4 million, and an accumulated deficit of $735.1 million.
Previous wording
We have historically incurred significant annual operating losses. Our net losses were $68.9 million and $128.3 million for the years ended December 31, 2025 and 2024, respectively. As of June 30, 2026, we had an accumulated deficit of $498.7 million. We expect to incur significant expenses for the foreseeable future as we continue commercialization of YUTREPIA and advance our product candidates through clinical trials, seek regulatory approval of such product candidates and pursue commercialization of any such approved product candidates. These efforts require significant amounts of capital, adequate personnel and infrastructure, and extensive compliance-reporting capabilities. It is uncertain whether and when, if ever, we will realize sustained revenue from sales of such additional product candidates. Additionally, our HCR Agreement contains fixed quarterly payments and minimum cash covenants that require us to maintain cash and cash equivalents in an amount at least equal to $15.0 million for the remainder of the payment term, which based on amounts funded as of June 30, 2026, is expected to conclude in 2033.
Current wording
We have historically incurred significant annual operating losses. Our net losses were $68.9 million and $128.3 million for the years ended December 31, 2025 and 2024, respectively. As of September 30, 2026, we had an accumulated deficit of $735.1 million. We expect to incur significant expenses for the foreseeable future as we continue commercialization of YUTREPIA and advance our product candidates through clinical trials, seek regulatory approval of such product candidates and pursue commercialization of any such approved product candidates. These efforts require significant amounts of capital, adequate personnel and infrastructure, and extensive compliance-reporting capabilities. It is uncertain whether and when, if ever, we will realize sustained revenue from sales of such additional product candidates. Additionally, our HCR Agreement contains fixed quarterly payments and minimum cash covenants that require us to maintain cash and cash equivalents in an amount at least equal to $45.0 million for the remainder of the payment term, which based on amounts funded as of September 30, 2026, is expected to conclude in 2033. In addition, the UTC Letters of Credit are partially cash collateralized and as of October 23, 2026, $105.4 million of cash and cash equivalents has been legally restricted and is not available for operations until the UTC Payments have been made.
Previous wording
We believe we will have sufficient cash and cash equivalents to meet our financial obligations and minimum cash covenants for at least the next twelve months. While we have included anticipated cash inflows from YUTREPIA product sales in our projections, we may not be able to generate sustained revenue from YUTREPIA and the resources needed to support development of L606 may not be accurate. We have based our estimates on assumptions that may prove to be wrong, and we could be limited in our ability to continue to commercialize YUTREPIA and/or use our available capital resources sooner than we currently expect. In the event revenues from YUTREPIA are insufficient to support our business operations and future capital needs, we expect that we would need further financing or we could be forced to delay, limit, reduce or terminate clinical studies or other ongoing activities, which could have a material adverse effect on our business, results of operations, and financial condition.
Current wording
Our future funding requirements will be heavily determined by our ability to continue to successfully commercialize YUTREPIA and the resources needed to support further development of our products and product candidates. We believe we will have sufficient unrestricted cash and cash equivalents to meet our financial obligations, including the settlement payments discussed above, and to comply with minimum cash covenants for at least the next twelve months. We have included anticipated cash inflows from YUTREPIA product sales in our projections; actual cash inflows will depend on our ability to collect our outstanding receivables and the magnitude of potential returns. We have based our estimates on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. In the event revenues and cash inflows from YUTREPIA are insufficient to support our business operations and future capital needs, we expect that we would need further financing or we could be forced to delay, limit, reduce or terminate clinical studies or other ongoing activities, which could have a material adverse effect on our business, results of operations, and financial condition.
Previous wording
Net cash provided by operating activities increased $203.4 million to $133.2 million for the six months ended June 30, 2026, compared to net cash used in operating activities of $70.2 million for the six months ended June 30, 2025. The increase was primarily due to $216.1 million higher net income adjusted for non-cash items offset by unfavorable working capital changes of $12.8 million.
Current wording
Net cash provided by operating activities increased $359.8 million to $279.9 million for the nine months ended September 30, 2026, compared to net cash used in operating activities of $79.9 million for the nine months ended September 30, 2025. The increase was primarily driven by a $371.3 million year-over-year change in operating assets and liabilities, largely reflecting the recognition of litigation settlement charges for which the associated cash payments will occur after September 30, 2026. This was partially offset by $11.5 million higher net loss adjusted for non-cash items.
Previous wording
Net cash used in investing activities was $15.1 million for the six months ended June 30, 2026, compared to $1.4 million for the six months ended June 30, 2025. During the six months ended June 30, 2026, we used $14.1 million to purchase property, plant and equipment and paid a $1.0 million L606 development milestone payment. During the six months ended June 30, 2025, net cash used in investing activities related to property, plant, and equipment purchases.
Current wording
Net cash used in investing activities was $32.0 million for the nine months ended September 30, 2026, compared to $2.3 million for the nine months ended September 30, 2025. During the nine months ended September 30, 2026, we used $31.0 million to purchase property, plant and equipment and paid a $1.0 million L606 development milestone payment. During the nine months ended September 30, 2025, net cash used in investing activities related to property, plant, and equipment purchases.
Previous wording
Net cash used in financing activities was $24.7 million during the six months ended June 30, 2026, compared to $72.0 million provided by financing activities during the six months ended June 30, 2025. During the six months ended June 30, 2026, we made $28.0 million in payments under the HCR Agreement. These outflows were offset by $3.2 million received from the issuance of common stock under stock incentive plans. During the six months ended June 30, 2025, we received $75.0 million net proceeds from the HCR Agreement and $1.4 million from the issuance of common stock under stock incentive plans. These inflows were offset by $5.0 million in payments under the HCR Agreement.
Current wording
Net cash used in financing activities was $42.5 million during the nine months ended September 30, 2026, compared to $66.7 million provided by financing activities during the nine months ended September 30, 2025. During the nine months ended September 30, 2026, we made $48.0 million in payments under the HCR Agreement. These outflows were offset by $5.3 million received from the issuance of common stock under stock incentive plans. During the nine months ended September 30, 2025, we received $75.0 million net proceeds from the HCR Agreement and $3.9 million from the issuance of common stock under stock incentive plans. These inflows were offset by $13.0 million in payments under the HCR Agreement.
Previous wording
Under the Pharmosa License Agreement, we were granted an exclusive license in North America to develop and commercialize L606, an inhaled, sustained-release liposomal formulation of treprostinil currently being evaluated in a clinical trial for the treatment of PAH and PH-ILD. Under the First Amendment, we expanded our licensed territory to include key markets in Europe, Japan and elsewhere, in addition to licensing proprietary nebulizers controlled by Pharmosa and being evaluated for use in a global pivotal study for the treatment of PH-ILD. In consideration for these exclusive rights, we will pay Pharmosa potential development milestone payments tied to clinical development and approvals in PAH and/or PH-ILD of up to $37.75 million, potential sales milestones of up to $185 million in North America and $150 million outside North American and two tiers of low, double-digit royalties on net sales of L606. Pharmosa will also receive a $10 million milestone payment for each additional indication approved by the FDA after PAH and PH-ILD and each additional product approved by the FDA under the license, a $2 million milestone payment for each additional indication approved by the EMA after PAH and PH-ILD, and a $0.5 million milestone payment for each additional indication approved by the PMDA after PAH and PH-ILD. As of June 30, 2026, no development milestones have been achieved under the Pharmosa License Agreement.
Current wording
Pharmosa and being evaluated for use in a global pivotal study for the treatment of PH-ILD. In consideration for these exclusive rights, we will pay Pharmosa potential development milestone payments tied to clinical development and approvals in PAH and/or PH-ILD of up to $37.75 million, potential sales milestones of up to $185 million in North America and $150 million outside North America and two tiers of low, double-digit royalties on net sales of L606. Pharmosa will also receive a $10 million milestone payment for each additional indication approved by the FDA after PAH and PH-ILD and each additional product approved by the FDA under the license, a $2 million milestone payment for each additional indication approved by the EMA after PAH and PH-ILD, and a $0.5 million milestone payment for each additional indication approved by the PMDA after PAH and PH-ILD. As of September 30, 2026, no development milestones have been achieved under the Pharmosa License Agreement.
Previous wording
The Vectura License Agreement provides for, among other things, (i) the exclusive right for us to develop, manufacture and commercialize for use in the Vectura Territory products containing treprostinil, including L606, administered via the Vectura Device for treatment in the field of hypertension and interstitial lung diseases, including PAH and PH-ILD, and (ii) that Vectura shall be responsible for manufacturing and supplying us with clinical and commercial supplies of the Vectura Device. Under the Vectura License Agreement, we paid Vectura an upfront payment of $2.0 million and will pay (i) certain development milestone payments of up to $12.0 million; (ii) certain sales milestone payments of up to $92.5 million tied to commercial sales in the Vectura Territory and (iii) royalty payments with royalty rates ranging in the middle single digits tied to commercial sales in the Vectura Territory. As of June 30, 2026, development milestones of $1.0 million has been achieved and paid under the Vectura License Agreement. The Vectura License Agreement also provides us with rights of first negotiation to add additional territories and indications during the term thereof.
Current wording
The Vectura License Agreement provides for, among other things, (i) the exclusive right for us to develop, manufacture and commercialize for use in the Vectura Territory products containing treprostinil, including L606, administered via the Vectura Device for treatment in the field of hypertension and interstitial lung diseases, including PAH and PH-ILD, and (ii) that Vectura shall be responsible for manufacturing and supplying us with clinical and commercial supplies of the Vectura Device. Under the Vectura License Agreement, we paid Vectura an upfront payment of $2.0 million and will pay (i) certain development milestone payments of up to $12.0 million; (ii) certain sales milestone payments of up to $92.5 million tied to commercial sales in the Vectura Territory and (iii) royalty payments with royalty rates ranging in the middle single digits tied to commercial sales in the Vectura Territory. As of September 30, 2026, a development milestone of $1.0 million has been achieved and paid under the Vectura License Agreement. The Vectura License Agreement also provides us with rights of first negotiation to add additional territories and indications during the term thereof.
Previous wording
Under the CSA, we deliver bulk treprostinil powder, manufactured using our proprietary PRINT technology, and Lonza encapsulates and packages it. The CSA was effective upon signing and will be in effect until December 31, 2028 and may thereafter be extended upon the mutual written agreement of the parties in accordance with the terms of the CSA. We are required to provide Lonza with quarterly forecasts of our expected production requirements for the following 24-month period, the first twelve months of which is considered a binding, firm order. We are required to purchase certain
Current wording
Under the CSA, we deliver bulk treprostinil powder, manufactured using our proprietary PRINT technology, and Lonza encapsulates and packages it. The CSA was effective upon signing and will be in effect until December 31, 2028 and may thereafter be extended upon the mutual written agreement of the parties in accordance with the terms of the CSA. We are required to provide Lonza with quarterly forecasts of our expected production requirements for the following 24-month period, the first twelve months of which is considered a binding, firm order. We are required to purchase certain minimum annual order quantities, which may be adjusted by us after the thirteenth month after receipt of regulatory approval of YUTREPIA. The CSA provides for tiered pricing depending upon the batch size ordered.
Previous wording
As of June 30, 2026, we have non-cancelable commitments for product manufacturing and supply costs of approximately $69.1 million.
Current wording
As of September 30, 2026, we have non-cancelable commitments for product manufacturing and supply costs of approximately $81.7 million.
Previous wording
We are party to three operating leases for laboratory, manufacturing, and office space. These leases expire on January 31, 2028, with an option to extend for an additional year with appropriate notice; December 31, 2031, with an option to extend for an additional period of five years with appropriate notice; and on November 1, 2036, with the option to extend for two additional periods of five years each with appropriate notice. Minimum operating lease payments under these leases are $1.4 million in the remaining six months of 2026, $5.1 million in 2027, $5.0 million in 2028, $5.1 million in 2029, $5.3 million in 2030, and $24.3 million thereafter.
Current wording
We are party to three operating leases for laboratory, manufacturing, and office space. These leases expire, respectively, on January 31, 2028, with an option to extend for an additional year with appropriate notice; December 31, 2031, with an option to extend for an additional period of five years with appropriate notice; and on November 1, 2036, with the option to extend for two additional periods of five years each with appropriate notice. Minimum operating lease payments under these leases are $1.0 million in the remaining three months of 2026, $5.1 million in 2027, $5.0 million in 2028, $5.1 million in 2029, $5.3 million in 2030, and $24.3 million thereafter.
Previous wording
We base our expenses related to CROs and CMOs on our estimates of the services received and efforts expended pursuant to quotations and contracts with such vendors that conduct research and development and manufacturing activities on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the applicable research and development or manufacturing expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepaid expense accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in us reporting amounts that are too high or too low in any particular period.
Current wording
activities on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the applicable research and development or manufacturing expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepaid expense accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in us reporting amounts that are too high or too low in any particular period.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
2025, following receipt of full FDA approval for YUTREPIA on May 23, 2025. The increase of $464.8 million was due to higher volume of YUTREPIA sales.
Current report — wording carried from elsewhere
driven by higher headcount, and a $4.1 million increase in commercial and consulting expenses to support the commercialization of YUTREPIA.
Current report — wording carried from elsewhere
Under the Pharmosa License Agreement, we were granted an exclusive license in North America to develop and commercialize L606, an inhaled, sustained-release liposomal formulation of treprostinil currently being evaluated in a clinical trial for the treatment of PAH and PH-ILD. Under the First Amendment, we expanded our licensed territory to include key markets in Europe, Japan and elsewhere, in addition to licensing proprietary nebulizers controlled by
Current report — wording carried from elsewhere
We base our expenses related to CROs and CMOs on our estimates of the services received and efforts expended pursuant to quotations and contracts with such vendors that conduct research and development and manufacturing
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
minimum annual order quantities, which may be adjusted by us after the thirteenth month after receipt of regulatory approval of YUTREPIA. The CSA provides for tiered pricing depending upon the batch size ordered.