UNITED THERAPEUTICS Corp

June 30, 2025 (Unaudited)

1. Organization and Business Description

United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of innovative products to address the unmet medical needs of patients with chronic and life-threatening conditions. In 2021, we converted to a Delaware public benefit corporation, with the express public benefit purposeto provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs.

We have approval from the U.S. Food and Drug Administration (FDA) to market the following therapies: Tyvaso DPI® (treprostinil) Inhalation Powder (Tyvaso DPI), Tyvaso® (treprostinil) Inhalation Solution (Nebulized Tyvaso), Remodulin® (treprostinil) Injection (Remodulin), Orenitram® (treprostinil) Extended-Release Tablets (Orenitram), Unituxin® (dinutuximab) Injection (Unituxin), and Adcirca® (tadalafil) Tablets (Adcirca). We also derive revenues outside the United States from sales of Nebulized Tyvaso, Remodulin, and Unituxin, and within the United States from sales of commercialex vivo lung perfusion services.

As used in these notes to our consolidated financial statements, unless the context otherwise requires, the terms “we”, “us”, “our”, and similar terms refer to United Therapeutics Corporation and its consolidated subsidiaries.

2. Basis of Presentation

The accompanying unaudited consolidated financial statements have been prepared in accordance with the rules and regulations of the U.S. Securities and Exchange Commission (SEC) for interim financial information. Accordingly, they do not include all of the information required by U.S. generally accepted accounting principles for complete financial statements. These consolidated financial statements should be read in conjunction with our audited consolidated financial statements and the accompanying notes to our consolidated financial statements contained in our Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on February 26, 2025.

In our management’s opinion, the accompanying consolidated financial statements contain all adjustments, including normal, recurring adjustments, necessary to fairly present our financial position as of June 30, 2025 and December 31, 2024, our statements of operations, comprehensive income, and stockholders’ equity for the three- and six-month periods ended June 30, 2025 and 2024, and our statements of cash flows for the six-month periods ended June 30, 2025 and 2024. Interim results are not necessarily indicative of results for an entire year. Certain prior year amounts have been reclassified to conform to the current year presentation. In the consolidated balance sheets, we reclassified the prior year amount within share tracking awards plan toother current liabilitiesto conform with the current period presentation.

Recently Issued Accounting Standards

Accounting Standards Adopted During the Period

None.

Accounting Standards Not Yet Adopted

In December 2023, the FASB issued Accounting Standards Update (ASU) 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, enhancing the required disclosures primarily related to the annual income tax rate reconciliation and income taxes paid. This ASU requires an entity’s income tax rate reconciliation to provide additional information for reconciling items meeting a quantitative threshold, and to disclose certain selected categories within the income tax rate reconciliation. This ASU also requires entities to disclose the amount of income taxes paid, disaggregated by federal, state, and foreign taxes. This ASU is effective for the Company’s Annual Report on Form 10-K for the year ended December 31, 2025. The adoption of ASU 2023-09 will expand our income tax disclosures, but will have no impact on reported income tax expense or related tax assets or liabilities.

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Topic 220): Disaggregation of Income Statement Expenses, which requires public business entities to disclose, on an annual and interim basis, disaggregated information about certain income statement expense line items in the notes to the financial statements. Public business entities are required to apply the guidance prospectively and may elect to apply it retrospectively. This ASU is effective for annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027, although early adoption is permitted. We are evaluating the impact of adopting this guidance on our consolidated financial statements.

3. Investments

Marketable Investments

Available-for-Sale Debt Securities

Available-for-sale debt securities are recorded at fair value, with the portion of the unrealized gains and losses that are not credit-related included as a component ofaccumulated other comprehensive loss in stockholders’ equity, until realized. Available-for-sale debt securities consisted of the following (in millions):

The following tables present gross unrealized losses and fair value for those available-for-sale debt securities that were in an unrealized loss position as of June 30, 2025 and December 31, 2024, aggregated by investment category and length of time that the individual securities have been in a continuous loss position (in millions):

As of June 30, 2025 and December 31, 2024, we held 181 and 227 available-for-sale debt securities, respectively, that were in an unrealized loss position. In assessing whether the decline in fair value as of June 30, 2025 of any of these securities resulted from a credit loss, we consulted with our investment managers and reviewed the credit ratings for each security. We believe that these unrealized losses are a direct result of the current interest rate environment and do not represent an indication of credit loss. We do not intend to sell the investments in unrealized loss positions prior to their maturity and it is not more likely than not that we will be required to sell these investments before recovery of their amortized cost basis. There wereno impairments due to credit loss on our available-for-sale debt securities during the three and six months ended June 30, 2025 and 2024.

The following table summarizes the contractual maturities of available-for-sale debt securities (in millions). Actual maturities may differ from contractual maturities because the issuers of certain of these debt securities have the right to call the securities or prepay their obligations under the securities with or without penalties.

Investments in Equity Securities with Readily Determinable Fair Values

We held investments in equity securities with readily determinable fair values, in the aggregate, of $14.6 million and $23.9 million as of June 30, 2025 and December 31, 2024, respectively, which are included incurrent marketable investments in our consolidated balance sheets. Changes in the fair value of publicly-traded equity securities are recorded in our consolidated statements of operations within other (expense) income, net. See Note 4—Fair Value Measurements.

Investments in Privately-Held Companies

As of June 30, 2025 and December 31, 2024, we maintained non-controlling equity investments in privately-held companies of $59.0 million in the aggregate. We measure these investments using the measurement alternative because the fair values of these investments are not readily determinable. Under this alternative, the investments are measured at cost, less any impairment, and adjusted for any observable price changes. We include our investments in privately-held companies within other non-current assets in our consolidated balance sheets. These investments are subject to a periodic impairment review and, if impaired, the investment is measured and recorded at fair value in accordance with ASC 820, Fair Value Measurements.

4. Fair Value Measurements

We account for certain assets and liabilities at fair value and classify these assets and liabilities within the fair value hierarchy (Level 1, Level 2, or Level 3). Our other current assets and other current liabilities have fair values that approximate their carrying values.

Assets and liabilities subject to fair value measurements are as follows (in millions):

(1)Included incash and cash equivalents in our consolidated balance sheets.

(2)Included incash and cash equivalents andcurrent andnon-current marketable investments in our consolidated balance sheets. See Note 3—Investments—Marketable Investments—Available-for-Sale Debt Securities for further information. The fair value of these securities is principally measured or corroborated by trade data for identical securities for which related trading activity is not sufficiently frequent to be considered a Level 1 input or comparable securities that are more actively traded.

(3)Included incurrent marketable investments in our consolidated balance sheets. The fair value of these securities is based on quoted market prices for identical instruments in active markets. During thethree and six months ended June 30, 2025, we recognized $4.0 million and $9.3 million of net unrealized losses, respectively on these securities. During the three and six months ended June 30, 2024 we recognized $0.4 million and $6.0 million of net unrealized gains, respectively, on these securities. We recorded these gains and losses in our consolidated statements of operations within other (expense) income, net. See Note 3—Investments—Marketable Investments—Investments in Equity Securities with Readily Determinable Fair Values.

(4)Included in other current liabilities andother non-current liabilities in our consolidated balance sheets. The fair value of our contingent consideration obligations is estimated using probability-weighted discounted cash flow models (DCFs). The DCFs incorporate Level 3 inputs, including estimated discount rates, that we believe market participants would consider relevant in pricing and the projected timing and amount of cash flows, which are estimated and developed, in part, based on the requirements specific to each acquisition agreement. The fair value of our contingent consideration liabilities increased by $4.1 million during the period from December 31, 2024 to June 30, 2025. The loss was recorded within research and developmentin our consolidated statements of operations.

Fair Value of Financial Instruments

The carrying amounts ofcash and cash equivalents, accounts receivable, andaccounts payable and accrued expenses approximate fair value because of their short maturities. The fair values of our marketable investments and contingent consideration are reported above within the fair value hierarchy. See Note 3—Investments. The carrying value of our debt is a reasonable estimate of the fair value of the outstanding debt based on the variable interest rate of the debt.

5. Inventories

Inventories are stated at the lower of cost (first-in, first-out method) or net realizable value and consist of the following, net of reserves (in millions):

6. Property, Plant, and Equipment

Property, plant, and equipment consists of the following (in millions):

Depreciation expense for the six months ended June 30, 2025 and 2024 was $40.5 million and $33.4 million, respectively.

On July 23, 2025, we acquired approximately 60 acres of property containing five buildings located in Research Triangle Park, North Carolina (RTP) for future growth on our RTP campus. The total purchase price was $107.0 million, inclusive of taxes, closing costs, and other related expenses.

7. Debt

2025 Credit Agreement

In April 2025, we entered into a credit agreement (the 2025 Credit Agreement) with Wells Fargo Bank, National Association (Wells Fargo) as administrative agent and a swingline lender, and various other lender parties, which provides for an unsecured revolving credit facility of up to $2.5 billion (which facility may, at our request, be increased by up to $750 million in the aggregate subject to obtaining commitments from existing or new lenders for such increase and other conditions). The facility will mature on April 25, 2030, subject to the lenders’ ability to extend the maturity date byone year if we request such an extension in accordance with the terms of the 2025 Credit Agreement, up to a maximum oftwo such extensions.

At our option, amounts borrowed under the 2025 Credit Agreement bear interest at either an adjusted Term Secured Overnight Finance Rate (Term SOFR) or a fluctuating base rate, in each case, plus an applicable margin determined on a quarterly basis based on our consolidated ratio of total indebtedness to EBITDA (as calculated in accordance with the 2025 Credit Agreement). To date, we have elected to calculate interest on the outstanding balance at an adjusted Term SOFR plus an applicable margin.

On April 25, 2025, we borrowed $200.0 million under the 2025 Credit Agreement, and used the funds to repay outstanding indebtedness under the 2022 Credit Agreement, as discussed below under the 2022 Credit Agreement.

During the three months ended June 30, 2025, we paid down the entire $200.0 million balance under the 2025 Credit Agreement, which brought our aggregate outstanding balance tozero as of June 30, 2025.

The 2025 Credit Agreement contains customary events of default and customary affirmative and negative covenants. As of June 30, 2025, we were in compliance with these covenants.

The interest expense reported in our consolidated statements of operations for the six months ended June 30, 2025 and 2024 relates to our borrowings under the 2025 Credit Agreement and 2022 Credit Agreement.

2022 Credit Agreement

In March 2022, we entered into a credit agreement (the 2022 Credit Agreement) with Wells Fargo, as administrative agent and a swingline lender, and various other lender parties, providing for: (1) an unsecured revolving credit facility of up to $1.2 billion; and (2) a second unsecured revolving credit facility of up to $800.0 million.

As of December 31, 2024, our outstanding aggregate principal balance under the 2022 Credit Agreement was $300.0 million. During the first quarter of 2025, we paid down $100.0 million of our balance under the 2022 Credit Agreement, which brought our aggregate outstanding balance down to $200.0 million as of March 31, 2025.

On April 25, 2025, we terminated the 2022 Credit Agreement and entered into the 2025 Credit Agreement. We repaid in full all our obligations under the 2022 Credit Agreement in connection with the termination of the 2022 Credit Agreement and our entry into the 2025 Credit Agreement. There were no penalties associated with the early termination of the 2022 Credit Agreement.

8. Share-Based Compensation

As of June 30, 2025, we haveone shareholder-approved equity incentive plan: the United Therapeutics Corporation Amended and Restated 2015 Stock Incentive Plan (the 2015 Plan). The 2015 Plan provides for the issuance of up to 14,770,000 shares of our common stock pursuant to awards granted under the 2015 Plan, which includes 950,000 shares that were added pursuant to an amendment and restatement of the 2015 Plan approved by our shareholders in June 2025. We also haveone equity incentive plan, the United Therapeutics Corporation 2019 Inducement Stock Incentive Plan (the 2019 Inducement Plan), that has not been approved by our shareholders, as permitted by the Nasdaq Stock Market rules. The 2019 Inducement Plan was approved by our Board of Directors in February 2019 and provides for the issuance of up to 99,000 shares of our common stock under awards granted to newly-hired employees. Currently, we grant equity-based awards to employees and members of our Board of Directors in the form of stock options and restricted stock units (RSUs) under the 2015 Plan, and we may grant RSUs to newly-hired employees under the 2019 Inducement Plan. See the sections entitled Stock Optionsand RSUs below for additional information regarding these equity-based awards.

During the six months ended June 30, 2025 and 2024, we issued stock options and RSUs to certain executives with vesting conditions tied to the achievement of specified performance criteria through the end of 2027 and 2026, respectively. Additionally, during the six months ended June 30, 2025 we issued RSUs to certain other employees with vesting conditions tied to the achievement of specified performance criteria through the end of 2026 and 2028. Throughout the performance period, we reassess the estimated performance and update the number of performance-based awards that we believe will ultimately vest. Estimating future performance requires the use of judgment. Upon the conclusion of the performance period, the performance level achieved and the ultimate number of stock options and RSUs that may vest are determined. Share-based compensation expense for these awards is recorded ratably over their vesting period, depending on the specific terms of the award and anticipated achievement of the specified performance criteria.

We previously issued awards under the United Therapeutics Corporation 2011 Share Tracking Awards Plan (the STAP). We discontinued the issuance of STAP awards in June 2015 and all remaining outstanding STAP awards were exercised during the first quarter of 2025. See the section entitled STAP Awards below for additional information regarding STAP awards.

In 2012, our shareholders approved the United Therapeutics Corporation Employee Stock Purchase Plan (ESPP), which is structured to comply with Section 423 of the Internal Revenue Code. See the section entitled ESPP below for additional information regarding the ESPP.

The following table reflects the components of share-based compensation expense recognized in our consolidated statements of operations (in millions):

Stock Options

We estimate the fair value of stock options using the Black-Scholes-Merton valuation model, which requires us to make certain assumptions that can materially impact the estimation of fair value and related compensation expense. The

assumptions used to estimate fair value include the price of our common stock, the expected volatility of our common stock, the risk-free interest rate, the expected term of stock option awards, and the expected dividend yield.

During the six months ended June 30, 2025 and 2024, in addition to time-based stock options, we granted 0.3 million and 0.5 million performance-based stock options with a total grant date fair value of $38.0 million and $50.2 million, respectively, in each case, calculated based on the assumed achievement of maximum performance of the relevant financial performance condition. During the three and six months ended June 30, 2025 we recorded $10.3 million and $18.0 million of share-based compensation expense, respectively, related to performance-based stock options, calculated based on the assumed levels of performance achievement, as compared to $7.1 million and $11.9 million for the same periods in 2024.

The following weighted average assumptions were used in estimating the fair value of stock options granted to employees during the six months ended June 30, 2025 and 2024:

A summary of the activity and status of stock options under the 2015 Plan during the six-month period ended June 30, 2025 is presented below:

The weighted average fair value of a stock option granted during each of the six-month periods ended June 30, 2025 and June 30, 2024 was $110.11 and $97.24, respectively. These stock options have an aggregate grant date fair value of $39.0 million and $52.1 million, respectively. The total grant date fair value of stock options that vested during the six-month periods ended June 30, 2025 and June 30, 2024 was $1.4 million and $0.9 million, respectively.

Total share-based compensation expense related to stock options was recorded as follows (in millions):

As of June 30, 2025, unrecognized compensation cost related to stock options was $73.3 million. Unvested outstanding stock options as of June 30, 2025 had a weighted average remaining vesting period of 2.1 years.

Stock option exercise data is summarized below (dollars in millions):

RSUs

Each RSU entitles the recipient toone share of our common stock upon vesting. We measure the fair value of RSUs using the stock price on the date of grant. Share-based compensation expense for RSUs is recorded ratably over their vesting period.

During the six-month periods ended June 30, 2025 and 2024, in addition to time-based RSUs, we granted 0.1 million and 0.2 million performance-based RSUs to certain executives with a total grant date fair value of $38.0 million and $47.5 million, respectively, calculated based on the assumed achievement of maximum performance of the relevant financial and non-financial performance conditions. Additionally, during the six months ended June 30, 2025, in addition to time-based RSUs, we granted 0.1 million performance-based RSUs to certain other employees with a total grant date fair value of $29.3 million, calculated based on the assumed achievement of maximum performance of the relevant financial and non-financial performance conditions. During the three and six months ended June 30, 2025, we recorded $9.8 million and $18.1 million of share-based compensation expense, respectively, related to performance-based RSUs, calculated based on the assumed levels of performance achievement as compared to $5.1 million and $7.2 million for the same periods in 2024.

A summary of the activity with respect to, and status of, RSUs during the six-month period ended June 30, 2025 is presented below:

Total share-based compensation expense related to RSUs was recorded as follows (in millions):

As of June 30, 2025, unrecognized compensation cost related to the grant of RSUs was $209.1 million. Unvested outstanding RSUs as of June 30, 2025 had a weighted average remaining vesting period of 2.4 years.

STAP Awards

STAP awards conveyed the right to receive in cash an amount equal to the appreciation of our common stock, which was measured as the increase in the closing price of our common stock between the dates of grant and exercise. STAP awards expired on thetenth anniversary of the grant date, and in most cases, they vested in equal increments on each anniversary of the grant date over afour-year period. We discontinued the issuance of STAP awards in June 2015 and all remaining outstanding STAP awards were exercised during the first quarter of 2025.

The aggregate liability balance associated with outstanding STAP awards waszero and $11.0 million as of June 30, 2025 and December 31, 2024, respectively.

Share-based compensation expense (benefit) recognized in connection with STAP awards was as follows (in millions):

Cash paid to settle STAP awards exercised during the six-month periods ended June 30, 2025 and June 30, 2024 was $10.2 million and $31.9 million, respectively.

ESPP

The ESPP provides eligible employees with the right to purchase shares of our common stock at a discount through elective accumulated payroll deductions at the end of each offering period. Eligible employees may contribute up to 15 percent of their base salary, subject to certain annual limitations as defined in the ESPP. The purchase price of the shares is equal to the lower of 85 percent of the closing price of our common stock on either the first or last trading day of a given offering period. In addition, the ESPP provides that no eligible employee may purchase more than 4,000 shares during any offering period. The ESPP expires in June 2032 and limits the aggregate number of shares that can be issued under the ESPP to 3.0 million.

9. Stockholders’ Equity

Earnings Per Common Share

Basic earnings per common share is computed by dividing net income by the weighted average number of shares of common stock outstanding during the period. Diluted earnings per common share is computed by dividing net income by the weighted average number of shares of common stock outstanding during the period, adjusted for the potential dilutive effect of our outstanding stock options, outstanding RSUs, and shares issuable under the ESPP, as if the RSUs were vested, the stock options were exercised, and the shares expected to be issued under the ESPP at the end of the current offering period were issued.

Basic and diluted earnings per common share are computed independently for each quarter and the year-to-date period presented. The sum of the earnings per common share for each quarter in a year-to-date period may not equal the earnings per common share for such year-to-date period due to rounding.

The components of basic and diluted earnings per common share comprised the following (in millions, except per share amounts):

(1)Calculated using the treasury stock method.

(2)The common shares underlying certain stock options and RSUs have been excluded from the computation of diluted earnings per share because their impact would be anti-dilutive.

Share Repurchase

In March 2024, our Board of Directors approved a share repurchase program authorizing up to $1.0 billion in aggregate repurchases of our common stock. Pursuant to this authorization, we entered into an accelerated share repurchase agreement (the ASR agreement) with Citibank, N.A. (Citi) on March 25, 2024, to repurchase approximately $1.0 billion of our common stock. Under the ASR agreement, we made an aggregate upfront payment of $1.0 billion to Citi and received an aggregate initial delivery of 3,275,199 shares of our common stock on March 27, 2024, which represented approximately 80 percent of the total shares that would be repurchased under the ASR agreement, measured based on the closing price of our common stock on March 25, 2024.

The share repurchase under the ASR agreement was divided intotwo tranches, resulting in upfront payments of $300 million and $700 million, respectively. The final settlement of the $300 million tranche occurred in June 2024, and we received an additional 181,772 shares of our common stock upon settlement. The final settlement of the $700 million tranche occurred in September 2024, and we received an additional 90,403 shares of our common stock upon settlement. In total, we repurchased 3,547,374 shares of our common stock under the ASR agreement that we currently hold as treasury stock in our consolidated balance sheets.

The final number of shares that we ultimately repurchased pursuant to the ASR agreement was based on the average of the daily volume-weighted average price per share of our common stock during the repurchase period, less a discount and subject to adjustments pursuant to the terms and conditions of the ASR agreement.

The initial repurchase of our common stock and final settlement of each tranche was treated as a reduction of the outstanding shares used to calculate the weighted average common stock outstanding for basic and diluted earnings per common share. The initial repurchase of our common stock under each tranche was accounted for as a reduction to stockholders’ equity in our consolidated balance sheets. The final settlement of the transactions under the ASR agreement was accounted for as an unsettled forward contract indexed to our common stock until the final settlement occurred. The forward contract related to the first and second tranche was equity classified, in accordance with ASC 815, Derivatives and Hedging, through final settlement. During the three months ended June 30, 2025, we paid $5.0 million for an excise tax imposed under the Inflation Reduction Act as a result of our repurchase of shares under the ASR agreement.

10. Income Taxes

Our effective income tax rate (ETR) for the six months ended June 30, 2025 and 2024 was 24 percent and 22 percent, respectively. Our ETR for the six months ended June 30, 2025 increased compared to our ETR for the six months ended June 30, 2024 primarily due to decreased excess tax benefits from share-based compensation.

We record interest and penalties related to uncertain tax positions as a component of income tax expense. As of June 30, 2025 and December 31, 2024, our unrecognized tax benefits, including related interest, were approximately $25.9 million and $20.6 million, respectively. The total amount of unrecognized tax benefits relating to our tax positions as of June 30, 2025 is subject to change based on future events and it is reasonably possible that the balance could change significantly over the next 12 months. Given the uncertainty of future events, we are unable to reasonably estimate the range of possible adjustments to our unrecognized tax benefits.

On July 4, 2025, the One Big Beautiful Bill Act (OBBBA) was enacted into law in the United States. The OBBBA includes significant changes to U.S. tax law, including provisions that restore and permanently allow both the immediate deduction of domestic research and experimental expenditures and the full expensing of certain qualifying assets in the year placed in service. The OBBBA includes multiple effective dates, with certain provisions effective in 2025 and others in future years.

The impact of the OBBBA must be recognized in the period of enactment under ASC 740, Income Taxes. Accordingly, it is not reflected in the accompanying consolidated financial statements for the period ended June 30, 2025. We are evaluating the impact of the OBBBA on our consolidated financial statements.

11. Segment Information

Our Chief Executive Officer, as our chief operating decision maker (CODM), manages our company as a single operating and reporting segment at the consolidated level. Our operating segment focuses on the development and commercialization of products to address the unmet needs of patients with chronic and life-threatening conditions. The accounting policies of ourone operating segment are the same as those described in Note 2—Summary of Significant Accounting Policiesto our consolidated financial statements contained in our Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on February 26, 2025.

Our CODM is regularly provided with revenue and expense forecasts, including product development plans, to manage the operations of our operating segment. Our CODM compares forecasted to actual results for net income when assessing performance and allocating resources across the operating segment. Significant segment expenses are presented asoperating expensesin our consolidated statements of operations.

The measure of the operating segment’s assets is reported in our consolidated balance sheets astotal assets.

Total revenues, cost of sales, and gross profit (loss) for each of our commercial products and other were as follows (in millions):

(1) Total revenues and cost of sales include both the drug product and the respective inhalation device.

(2) Total revenues and cost of sales include sales of infusion devices, including the Remunity Pump.

Geographic revenues are determined based on the country to which our products are shipped. Total revenues from external customers in the United States and rest-of-world (ROW) for each of our commercial products were as follows (in millions):

(1) Net product sales include both the drug product and the respective inhalation device.

(2) Net product sales include sales of infusion devices, including the Remunity Pump.

We recorded revenue from two distributors in the United States that exceeded ten percent of total revenues. Revenue from these two distributors as a percentage of total revenues is as follows:

12. Litigation

Sandoz Litigation

In April 2019, Sandoz Inc. (Sandoz) and its marketing partner RareGen, LLC (now known as Liquidia PAH, LLC, a subsidiary of Liquidia Corporation) (RareGen), filed a complaint in the U.S. District Court for the District of New Jersey against us and Smiths Medical ASD, Inc. (Smiths Medical), alleging that we and Smiths Medical engaged in anticompetitive conduct in connection with the plaintiffs’ efforts to launch their generic version of Remodulin. In particular, the complaint alleged that we and Smiths Medical unlawfully impeded competition by entering into an agreement for Smiths Medical to produce cartridges used with the CADD-MS®3 (MS-3) infusion system specifically for the delivery of subcutaneous Remodulin for our patients, without making these cartridges available for the delivery of Sandoz’s generic treprostinil injection. In March 2020, the plaintiffs filed an amended complaint to add a count alleging that we breached our earlier patent settlement agreement with Sandoz by refusing to grant Sandoz access to cartridges purchased for our patients.

Smiths Medical was dismissed from the case in November 2020, based on a settlement resolving the disputes between the plaintiffs and Smiths Medical. As part of this settlement, Smiths Medical paid the plaintiffs $4.25 million, disclosed and made available to the plaintiffs certain specifications and other information related to the MS-3 cartridges, and granted to the plaintiffs a non-exclusive, royalty-free license in the United States to Smiths Medical’s patents and copyrights associated with the MS-3 cartridges and certain other information related to the MS-3 pumps and cartridges.

In March 2022, the court granted our motion for summary judgment with respect to all claims brought by the plaintiffs except the breach of contract claim. As a result, all antitrust claims, all claims under state competition laws, and the common law tortious interference claim were resolved in our favor. These were the only claims in the case that gave rise to any potential for trebling of damages, punitive damages, disgorgement, and/or the award of attorneys’ fees. The court also denied the plaintiffs’ request for injunctive relief.

The court granted Sandoz’s motion for summary judgment with respect to Sandoz’s breach of contract claim. The issue of what, if any, damages Sandoz is entitled to based on the court’s decision on the contract claim went to trial on April 29, 2024, and the court heard closing arguments on June 4, 2024. The trial was limited to determining the amount of damages under the breach of contract claim. The court issued an opinion on September 6, 2024, but did not determine the amount of damages with specificity. The court directed the parties to confer about the amount of damages based on the opinion and submit a proposed judgment with an amount of damages based on the factual findings in the opinion. On October 7, 2024, the parties submitted to the court their respective positions on damages. On November 1, 2024, the court entered a final judgment in favor of Sandoz, ordering us to pay to Sandoz (a) approximately $61.6 million in damages; (b) prejudgment interest in the amount of approximately $9.0 million; and (c) post-judgment interest. All parties have appealed the final judgment, including the court’s March 30, 2022 summary judgment decision. The appeal is pending before the U.S. Court of Appeals for the Third Circuit, and we expect oral argument to take place this year.

We accrued a liability of $71.1 million during 2024, and an additional $1.5 million through the second quarter of 2025, reflecting, in the aggregate, the damages and pre-judgment interest amounts awarded in the final judgment, as well as post-judgment interest accrued through June 30, 2025. We currently do not expect that the amount of any loss in excess of these accruals would be material to our financial results; however, the amount ultimately payable, if any, could be higher or lower than this amount depending on the amount of post judgment interest, and the outcome of appeals. We recorded this liability within other non-current liabilitiesin our consolidated balance sheets.

We intend to continue to vigorously defend ourselves against the claims made in this litigation. Among other things, we believe our settlement agreement with Sandoz did not provide Sandoz any rights with respect to delivery systems such as the MS-3. We also believe that the plaintiffs, who were on notice that Smiths Medical would discontinue the MS-3 system, failed to fulfill their duty to properly mitigate their exposure as a result of such discontinuation, and any damages they incurred are the result of market conditions and their own failure to properly plan their own product launch. However, due to the uncertainty inherent in any litigation, we cannot guarantee that appeals will not result in an outcome adverse to us. This litigation has involved, and will likely continue to involve, substantial cost to defend, and an adverse appellate outcome could result in substantial monetary damages in excess of the liability we have accrued to-date.

Litigation with Liquidia Technologies, Inc.

Since March 2020, we have been engaged in litigation with Liquidia Technologies, Inc. (Liquidia) regarding its efforts to obtain FDA approval for Yutrepia®, a dry powder inhalation formulation of treprostinil. That litigation has includedtwo petitions forinter partes review (IPR) filed by Liquidia with the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO), as well as multiple lawsuits we have brought alleging infringement by Liquidia of several of our patents. Most of these cases have now been finally resolved, and Liquidia received final approval from the FDA to market Yutrepia to treat PAH and PH-ILD in May 2025, and launched commercial sales in June 2025.

We have an ongoing patent infringement lawsuit against Liquidia, which was originally filed on September 5, 2023 in the U.S. District Court for the District of Delaware, alleging infringement of U.S. Patent No. 10,716,793 (the’793 patent), a patent related to Tyvaso with an expiration date in May 2027 that was later invalidated as a result of an IPR proceeding, and therefore is no longer at issue in this litigation. On November 30, 2023, we filed an amended complaint to assert a new patent: U.S. Patent No. 11,826,327 (the’327 patent), which expires February 3, 2042, and is now the only patent remaining at issue in the case. The claims of the ’327 patent generally cover improving exercise capacity in patients suffering from PH-ILD by inhaling treprostinil at specific dosages. Trial took place in June 2025, and the parties are engaged in post-trial briefing, which is scheduled to be completed in early August 2025. If we prevail in this lawsuit, we believe that we will be entitled to a court order requiring Liquidia to remove the PH-ILD indication from Yutrepia’s product labeling, and that we may also be entitled to damages.

In June 2021, we filed a motion in one of our earlier patent cases against Liquidia in the U.S. District Court for the District of Delaware to file an amended complaint adding trade secret misappropriation claims against Liquidia and a former Liquidia executive, Dr. Robert Roscigno. The court denied the motion based on a finding that adding the additional claims would impact the case schedule. Thus, we filed those claims as a separate case against Liquidia and Dr. Roscigno in North Carolina state court. Discovery is complete. On January 5, 2024, Dr. Roscigno filed a motion for summary judgment, which was denied on July 31, 2024. On July 3, 2024, Liquidia filed a motion for summary judgment, which was denied on July 23, 2025. We filed a new complaint on May 29, 2024, to commence a separate, related case against Liquidia and Dr. Roscigno in North Carolina

state court, which includes a claim for breach of contract. Liquidia moved to dismiss the new case, and the court denied that motion. On June 24, 2025, Liquidia filed an interlocutory notice of appeal of the decision denying its motion to dismiss. That appeal is pending, and no action has been taken beyond the filing of the notice of appeal.

On April 21, 2025, Liquidia filed a lawsuit against us in the U.S. District Court for the Middle District of North Carolina, alleging that Tyvaso DPI infringes U.S. Patent No. 10,898,494. This patent’s claims are directed to the treatment of pulmonary hypertension by administering specified amounts of treprostinil via a dry powder inhaler in a specified number of breaths. The patent expires May 5, 2037. Liquidia seeks damages and attorneys’ fees. We filed a motion to dismiss or, alternatively, a motion to stay the case based on the argument that we co-own the asserted patent based on Liquidia’s and Dr. Roscigno’s alleged trade secret misappropriation subject to the pending North Carolina state court litigation. That motion is pending. On May 9, 2025, we filed a lawsuit against Liquidia in the U.S. District Court for the Middle District of North Carolina, alleging that Yutrepia infringes U.S. Patent No. 11,357,782. This patent claims a method of treating pulmonary hypertension using inhaled treprostinil delivered using a specified dosage regimen. The patent expires May 14, 2027. We moved for a preliminary injunction, but the court denied that motion. Liquidia moved to dismiss or, alternatively, transfer the case to the U.S. District Court for the District of Delaware. That motion is pending.

We plan to continue to vigorously enforce our intellectual property rights related to Tyvaso DPI and Nebulized Tyvaso. In addition, we intend to vigorously defend ourselves against the claims made by Liquidia in its patent infringement lawsuit against us, which we believe are without merit.

FDA Litigation Regarding Yutrepia

On February 20, 2024, we filed an action against the FDA in the U.S. District Court for the District of Columbia regarding the FDA’s review of Liquidia’s efforts to obtain a PH-ILD indication for its Yutrepia product. Liquidia had previously submitted an amendment to its pending Yutrepia NDA to pursue approval for a PH-ILD indication. Our suit alleged that FDA rules, precedents, and procedures require that such a new indication be pursued in a new NDA rather than as an amendment to a pending NDA. Thus, we asked the FDA to require Liquidia to submit a new NDA if it desires to further pursue approval for a PH-ILD indication.

On March 4, 2024, we filed a motion for preliminary injunction and temporary restraining order seeking to prevent the FDA from approving the PH-ILD indication for Yutrepia by amendment. The court denied that motion on March 29, 2024, following a hearing on the motion.

On August 16, 2024, the FDA (1) confirmed that it was permitting Liquidia to add the PH-ILD indication to its pending Yutrepia NDA by amendment rather than requiring a new NDA and provided an explanation for that decision; and (2) granted Liquidia tentative approval for its Yutrepia NDA, including the PAH and PH-ILD indications. The FDA granted tentative rather than final approval because it determined that we were entitled to a period of exclusivity based on a clinical trial that we conducted to obtain approval for the PH-ILD indication, and that this exclusivity barred final approval of Liquidia’s product until expiration of exclusivity in May 2025. Following the FDA’s decisions, we voluntarily dismissed our case against the FDA.

On August 21, 2024, Liquidia filed an action against the FDA in the U.S. District Court for the District of Columbia challenging the FDA’s decisions to award us exclusivity and to withhold final approval for Yutrepia until that exclusivity has expired. We intervened, and the parties briefed and argued cross-motions for summary judgment and preliminary injunction. On February 27, 2025, the court issued a decision affirming the FDA’s award of exclusivity.

We also asserted a cross-claim against the FDA for improperly permitting Liquidia to pursue a PH-ILD indication in an amendment rather than a new NDA. This cross-claim is substantively identical to the claim we asserted against FDA in the action described above that we dismissed. We filed a motion for summary judgment on that cross-claim on January 17, 2025.

On April 17, 2025, we filed a motion for preliminary injunction on our cross-claim related to the PH-ILD indication that the FDA allowed Liquidia to pursue in an NDA amendment. The court denied the motion and later granted motions by Liquidia and FDA to dismiss our claims. No appeal was filed.

MSP Recovery Litigation

In July 2020, MSP Recovery Claims, Series LLC; MSPA Claims 1, LLC; and Series PMPI, a designated series of MAO-MSO Recovery II, LLC, filed a class action complaint against Caring Voices Coalition, Inc. (CVC) and us in the U.S. District Court for the District of Massachusetts. The complaint alleged that we violated the federal Racketeer Influenced and Corrupt Organizations (RICO) Act and various state laws by coordinating with CVC when making donations to a PAH fund so that those donations would go toward copayment obligations for Medicare patients taking drugs manufactured and marketed by us. The plaintiffs claim to have received assignments from various Medicare Advantage health plans and other insurance entities that allow them to bring this lawsuit on behalf of those entities to recover allegedly inflated amounts they paid for our drugs. In April 2021, the court granted our motion to transfer the case to the U.S. District Court for the Southern District of Florida.

In October 2021, the plaintiffs filed an amended complaint that includes state antitrust claims based on alleged facts similar to those raised by Sandoz and RareGen in the matter described above. The amended complaint added MSP Recovery Claims Series 44, LLC as a plaintiff and Smiths Medical and CVC as defendants. In December 2021, we filed a motion to dismiss all of the plaintiffs’ claims in the amended complaint, including the new antitrust claims. Smiths Medical also filed a motion to dismiss the plaintiffs’ claims against Smiths Medical. In September 2022, the court dismissed all of the plaintiffs’ claims against us and Smiths Medical without prejudice.

In October 2022, the plaintiffs filed a second amended complaint, which added federal antitrust claims and consumer protection claims under other states’ laws to the claims previously asserted. The second amended complaint also named Accredo Health Group, CVS Health Corporation, Express Scripts, Inc., and Express Scripts Holding Company (collectively, the Specialty Pharmacies), and the Adira Foundation as additional defendants. In March 2023, we filed our motion to dismiss the second amended complaint. The Specialty Pharmacies filed their own motion to dismiss, as did Smiths Medical. On March 22, 2024, the magistrate judge recommended dismissal of the plaintiffs’ complaint against all defendants in its entirety with prejudice, and for administrative purposes, issued an order dismissing the complaint. On April 12, 2024, the plaintiffs filed an objection to the magistrate judge’s recommendation. On May 10, 2024, we filed a response to the plaintiffs’ objection, as did the other defendants. If the district court judge adopts the magistrate judge’s recommendation and dismisses the case, the plaintiffs will have the right to appeal.

We intend to continue to vigorously defend ourselves against the claims made in this lawsuit.

Litigation with Humana and United Healthcare

Humana Inc. (Humana) and United Healthcare Services, Inc. (United) filed separate lawsuits against us in the U.S. District Court for the District of Maryland in December 2022 and November 2022, respectively. Each of these lawsuits includes allegations similar to those in the MSP Recovery matter discussed above concer ning our charitable contributions to CVC. In particular, these lawsuits allege that our donations to CVC violated RICO and various state laws. We filed motions to dismiss both of these lawsuits in March 2023. On March 25, 2024, the court dismissed both the Humana and United complaints in their entirety. In both cases, the RICO claims were dismissed with prejudice. In the Humana case, the state law claims were dismissed without prejudice, and in the United case, some of the state law claims were dismissed with prejudice, while others were dismissed without prejudice. Neither Humana nor United filed an appeal to date, and their deadlines for filing appeals have passed.

On April 24, 2024, Humana and United each filed lawsuits against us in the Circuit Court for Montgomery County, Maryland. These lawsuits include allegations similar to those in their lawsuits discussed above concerning charitable contributions. Humana and United allege that our donations to CVC give rise to common law causes of action, violations of state consumer protection statutes, and violations of insurance fraud statutes under the laws of various states. On July 22, 2024, we filed motions to dismiss both of these lawsuits. Oral argument on these motions to dismiss took place on October 24, 2024.

We intend to continue to vigorously defend ourselves against the claims made in these lawsuits.