UNITED THERAPEUTICS Corp
For the period ended Sep 30, 2026. Filed Nov 4, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 4, 2026
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to Consolidated Financial Statements
September 30, 2026 (Unaudited)
- 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.
- 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, 2025, as filed with the SEC on February 25, 2026.
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 September 30, 2026 and December 31, 2025, our statements of operations, comprehensive income, and stockholders’ equity for the three- and nine-month periods ended September 30, 2026 and 2025, and our statements of cash flows for the nine-month periods ended September 30, 2026 and 2025. Interim results are not necessarily indicative of results for an entire year. Certain prior period amounts in the consolidated statements of cash flows have been reclassified to conform to the current period presentation. Specifically, amounts previously included inother andother assets and liabilities within operating activities are now presented separately asnet unrealized losses on equity securitiesand deferred income taxes, respectively.
Recently Issued Accounting Standards
Accounting Standards Adopted During the Period
None.
Accounting Standards Not Yet Adopted
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.
| Quarterly Report | 9 |
|---|
- 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) income in stockholders’ equity, until realized. Available-for-sale debt securities consisted of the following (in millions):
| As of September 30, 2026 | AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | FairValue |
|---|---|---|---|---|
| U.S. government and agency securities | $1,837.7 | $0.2 | $(21.6) | $1,816.3 |
| Corporate debt securities | 440.0 | — | (5.4) | 434.6 |
| Total | $2,277.7 | $0.2 | $(27.0) | $2,250.9 |
| Reported under the following captions in our consolidated balance sheets: | |
|---|---|
| Cash and cash equivalents | $2.0 |
| Current marketable investments | 781.1 |
| Non-current marketable investments | 1,467.8 |
| Total | $2,250.9 |
| As of December 31, 2025 | AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | FairValue |
|---|---|---|---|---|
| U.S. government and agency securities | $2,433.0 | $10.5 | $(0.3) | $2,443.2 |
| Corporate debt securities | 603.1 | 3.7 | — | 606.8 |
| Total | $3,036.1 | $14.2 | $(0.3) | $3,050.0 |
| Reported under the following captions in our consolidated balance sheets: | |
|---|---|
| Cash and cash equivalents | $37.0 |
| Current marketable investments | 1,236.3 |
| Non-current marketable investments | 1,776.7 |
| Total | $3,050.0 |
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 September 30, 2026 and December 31, 2025, aggregated by investment category and length of time that the individual securities have been in a continuous loss position (in millions):
| Less than 12 months | 12 months or longer | Total | ||||
|---|---|---|---|---|---|---|
| As of September 30, 2026 | Fair Value | GrossUnrealizedLosses | Fair Value | GrossUnrealizedLosses | Fair Value | GrossUnrealizedLosses |
| U.S. government and agency securities | $1,718.7 | $(21.6) | $— | $— | $1,718.7 | $(21.6) |
| Corporate debt securities | 394.0 | (5.4) | — | — | 394.0 | (5.4) |
| Total | $2,112.7 | $(27.0) | $— | $— | $2,112.7 | $(27.0) |
| Less than 12 months | 12 months or longer | Total | ||||
|---|---|---|---|---|---|---|
| As of December 31, 2025 | Fair Value | GrossUnrealizedLosses | Fair Value | GrossUnrealizedLosses | Fair Value | GrossUnrealizedLosses |
| U.S. government and agency securities | $215.0 | $(0.3) | $3.5 | $— | $218.5 | $(0.3) |
| Corporate debt securities | 19.6 | — | — | — | 19.6 | — |
| Total | $234.6 | $(0.3) | $3.5 | $— | $238.1 | $(0.3) |
| 10 | United Therapeutics, a public benefit corporation |
As of September 30, 2026 and December 31, 2025, we held 331 and 87 available-for-sale debt securities, respectively, that were in an unrealized loss position. In assessing whether the decline in fair value as of September 30, 2026 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 nine months ended September 30, 2026 and 2025.
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.
| As of September 30, 2026 | ||
|---|---|---|
| Amortized Cost | Fair Value | |
| Due within one year | $784.5 | $783.1 |
| Due in one to three years | 1,493.2 | 1,467.8 |
| Total | $2,277.7 | $2,250.9 |
Investments in Equity Securities with Readily Determinable Fair Values
We held investments in equity securities with readily determinable fair values, in the aggregate, of $97.9 million and $126.9 million as of September 30, 2026 and December 31, 2025, respectively, which are included in current 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 income, net. See Note 4—Fair Value Measurements.
Investments in Privately Held Companies
As of September 30, 2026 and December 31, 2025, we maintained non-controlling equity investments in privately held companies of $90.1 million and $53.8 million, respectively. We invested zero and $25.0 million in privately held companies during the three and nine months ended September 30, 2026, respectively, as compared to $30.0 million during the three and nine months ended September 30, 2025. 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.
When an observable price transaction occurs that is identified as similar or identical to our investment, we perform a valuation analysis to assess the fair value of our investment using various inputs, such as the discount rate, time to a liquidation event, and price volatility of peer company stocks. We adjust the fair value of our investment based on the valuation analysis and recognize the gain or loss in the period in which the observable price change occurred. During the first quarter of 2026, one of the privately held companies in which we invested raised additional capital by issuing equity securities similar to ours at an increased valuation compared to prior financing rounds, which resulted in an increase of $12.8 million in the value of our investment. This gain was recorded within other income, netin our consolidated statements of operations.
During the third quarter of 2026, a privately held company in which we held an investment was acquired. We received $15.5 million in cash as a result of the acquisition and realized a gain of $14.0 million. The gain was recorded within other income, netin our consolidated statements of operations.
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.
For non-controlling equity investments in privately held companies in which we held an investment as of September 30, 2026, cumulative impairments and downward fair value adjustments were $5.3 million and cumulative upward fair value adjustments were $14.8 million.
| Quarterly Report | 11 |
|---|
- 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):
| As of September 30, 2026 | ||||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Balance | |
| Assets | ||||
| Money market funds(1) | $218.0 | $— | $— | $218.0 |
| Time deposits(1) | 211.4 | — | — | 211.4 |
| U.S. government and agency securities(2) | — | 1,816.3 | — | 1,816.3 |
| Corporate debt securities(2) | — | 434.6 | — | 434.6 |
| Equity securities(3) | 97.9 | — | — | 97.9 |
| Total assets | $527.3 | $2,250.9 | $— | $2,778.2 |
| Liabilities | ||||
| Contingent consideration(4) | — | — | 34.6 | 34.6 |
| Total liabilities | $— | $— | $34.6 | $34.6 |
| As of December 31, 2025 | ||||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Balance | |
| Assets | ||||
| Money market funds(1) | $753.1 | $— | $— | $753.1 |
| Time deposits(1) | — | — | — | — |
| U.S. government and agency securities(2) | — | 2,443.2 | — | 2,443.2 |
| Corporate debt securities(2) | — | 606.8 | — | 606.8 |
| Equity securities(3) | 126.9 | — | — | 126.9 |
| Total assets | $880.0 | $3,050.0 | $— | $3,930.0 |
| Liabilities | ||||
| Contingent consideration(4) | — | — | 32.5 | 32.5 |
| Total liabilities | $— | $— | $32.5 | $32.5 |
(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 the three and nine months ended September 30, 2026, we recognized $19.2 million of net unrealized gains and $29.0 million of net unrealized losses, respectively, on these securities. During the three and nine months ended September 30, 2025, we recognized $5.8 million of net unrealized gains and $3.5 million of net unrealized losses, respectively, on these securities. These net unrealized gains and losses are recorded within other income, netin our consolidated statements of operations. 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 $2.1 million during the period from December 31, 2025 to September 30, 2026. 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.
| 12 | United Therapeutics, a public benefit corporation |
- 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):
| September 30, 2026 | December 31, 2025 | |
|---|---|---|
| Raw materials | $35.6 | $30.6 |
| Work-in-progress | 37.4 | 35.3 |
| Finished goods | 128.9 | 117.2 |
| Total inventories | $201.9 | $183.1 |
- Property, Plant, and Equipment
Property, plant, and equipment consists of the following (in millions):
| September 30, 2026 | December 31, 2025 | |
|---|---|---|
| Land and land improvements | $320.5 | $266.5 |
| Buildings, building improvements, and leasehold improvements | 1,053.8 | 944.7 |
| Buildings under construction | 766.6 | 592.7 |
| Furniture, equipment, and vehicles | 537.3 | 493.6 |
| Subtotal | 2,678.2 | 2,297.5 |
| Less—accumulated depreciation | (636.3) | (567.8) |
| Property, plant, and equipment, net | $2,041.9 | $1,729.7 |
Depreciation expense for the nine months ended September 30, 2026 and 2025 was $69.1 million and $62.0 million, respectively.
- 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). In accordance with the terms of the 2025 Credit Agreement, in May 2026, we extended the maturity date of the 2025 Credit Agreement byone year, to April 2031. The 2025 Credit Agreement provides the lenders with the ability to extend the maturity date byone additional year, to April 2032, if we request such an extension.
At our option, amounts borrowed under the 2025 Credit Agreement bear interest at either an adjusted Term Secured Overnight Financing 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 second quarter of 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. Our aggregate outstanding balance under the 2025 Credit Agreement remained zero as of September 30, 2026.
The 2025 Credit Agreement contains customary events of default and customary affirmative and negative covenants. As of September 30, 2026, we were in compliance with these covenants.
The interest expense reported in our consolidated statements of operations for the nine months ended September 30, 2026 and 2025 relates to the 2025 Credit Agreement and 2022 Credit Agreement.
| Quarterly Report | 13 |
|---|
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, which provided 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.
- Share-Based Compensation
As of September 30, 2026, we haveone shareholder-approved equity incentive plan: the United Therapeutics Corporation 2026 Stock Incentive Plan (the 2026 Plan), which was approved by our shareholders on June 26, 2026. The 2026 Plan replaced the United Therapeutics Corporation Amended and Restated 2015 Stock Incentive Plan (the Prior Plan). As of June 26, 2026,3,913,730 shares were initially available for future grants, consisting of 2,413,730 shares that remained available for future grants under the Prior Plan and 1,500,000 newly authorized shares. In addition, as of September 30, 2026,10,802 shares subject to outstanding Prior Plan awards had been canceled, expired, forfeited, withheld for taxes, or otherwise not issued or settled in cash and therefore became available for future grants under the 2026 Plan, and an additional 4,238,060 shares subject to outstanding awards under the Prior Plan may become available if those awards are canceled, expired, forfeited, or otherwise not issued or are settled in cash. No further awards may be granted under the Prior Plan, although awards previously granted under the Prior Plan remained outstanding in accordance with their terms. 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 (Board) 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 in the form of stock options and restricted stock units (RSUs) under the 2026 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 nine months ended September 30, 2026 and 2025, we issued stock options and RSUs to certain executives with vesting conditions tied to the achievement of specified performance criteria through the end of 2028 and 2027, respectively. Additionally, during the nine months ended September 30, 2026 and 2025, we issued RSUs to certain other employees with vesting conditions tied to the achievement of specified performance criteria during specified performance periods, with the latest performance period ending in 2028. Throughout each performance period, we reassess the probability of achieving the performance criteria 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.
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.
| 14 | United Therapeutics, a public benefit corporation |
The following table reflects the components of share-based compensation expense recognized in our consolidated statements of operations (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Stock options | $11.0 | $11.3 | $35.3 | $30.9 |
| RSUs | 29.1 | 27.1 | 80.3 | 76.5 |
| STAP awards | — | — | — | (0.8) |
| ESPP | 0.9 | 0.7 | 2.7 | 2.1 |
| Total share-based compensation expense before tax | $41.0 | $39.1 | $118.3 | $108.7 |
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 nine months ended September 30, 2026 and 2025, in addition to time-based stock options, we granted 0.3 million performance-based stock options in each period with grant date fair values of $53.9 million and $38.0 million, respectively, calculated based on the assumed achievement of the relevant financial performance condition. During the three and nine months ended September 30, 2026, we recorded $9.5 million and $31.8 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 $10.3 million and $28.3 million for the same periods in 2025.
The following weighted average assumptions were used in estimating the fair value of stock options granted to employees during the nine months ended September 30, 2026 and 2025:
| September 30, 2026 | September 30, 2025 | |
|---|---|---|
| Expected term of awards (in years) | 4.9 | 5.1 |
| Expected volatility | 32.5% | 32.1% |
| Risk-free interest rate | 3.9% | 4.1% |
| Expected dividend yield | 0.0% | 0.0% |
A summary of the activity and status of stock options under the Prior Plan and the 2026 Plan during the nine-month period ended September 30, 2026 is presented below:
| Number ofOptions | WeightedAverageExercisePrice | WeightedAverageRemainingContractualTerm (in Years) | AggregateIntrinsicValue (in millions) | |
|---|---|---|---|---|
| Outstanding as of January 1, 2026 | 4,636,330 | $166.11 | ||
| Granted | 305,346 | 535.66 | ||
| Exercised | (2,054,008) | 137.31 | ||
| Forfeited | (565) | 267.47 | ||
| Outstanding as of September 30, 2026 | 2,887,103 | $225.66 | 4.5 | $913.0 |
| Exercisable as of September 30, 2026 | 1,708,761 | $150.43 | 2.9 | $668.9 |
| Unvested as of September 30, 2026 | 1,178,342 | $334.75 | 6.6 | $244.1 |
The weighted average fair value of a stock option granted during each of the nine-month periods ended September 30, 2026 and September 30, 2025 was $189.28 and $110.21, respectively. These stock options have an aggregate grant date fair value of $57.8 million and $41.6 million, respectively. The total grant date fair value of stock options that vested during the nine-month periods ended September 30, 2026 and September 30, 2025 was $39.3 million and $3.4 million, respectively.
| Quarterly Report | 15 |
|---|
Total share-based compensation expense related to stock options was recorded as follows (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Cost of sales | $— | $— | $— | $— |
| Research and development | 0.4 | 0.1 | 0.6 | 0.3 |
| Selling, general, and administrative | 10.6 | 11.2 | 34.7 | 30.6 |
| Share-based compensation expense before taxes | 11.0 | 11.3 | 35.3 | 30.9 |
| Related income tax benefit | (0.3) | (0.2) | (0.8) | (0.6) |
| Share-based compensation expense, net of taxes | $10.7 | $11.1 | $34.5 | $30.3 |
As of September 30, 2026, unrecognized compensation cost related to stock options was $68.7 million. Unvested outstanding stock options as of September 30, 2026 had a weighted average remaining vesting period of 1.9 years.
Stock option exercise data is summarized below (dollars in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Number of options exercised | 663,336 | 300,521 | 2,054,008 | 570,521 |
| Cash received | $87.4 | $40.2 | $282.0 | $74.9 |
| Total intrinsic value of options exercised | $255.4 | $77.4 | $816.8 | $130.2 |
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 nine months ended September 30, 2026 and 2025, in addition to time-based RSUs, we granted 0.2 million performance-based RSUs in each period with total grant date fair values of $90.2 million and $67.3 million, respectively, calculated based on the assumed achievement of the relevant financial and non-financial performance conditions. During the three and nine months ended September 30, 2026, we recorded $9.3 million and $24.7 million of share-based compensation expense, respectively, related to performance-based RSUs, calculated based on the assumed levels of performance achievement, as compared to $11.2 million and $29.3 million for the same periods in 2025.
A summary of the activity with respect to, and status of, RSUs during the nine-month period ended September 30, 2026 is presented below:
| Number ofRSUs | WeightedAverageGrant DateFair Value | |
|---|---|---|
| Unvested as of January 1, 2026 | 1,416,871 | $252.86 |
| Granted | 322,521 | 520.30 |
| Vested | (291,460) | 238.19 |
| Forfeited | (28,829) | 312.25 |
| Unvested as of September 30, 2026 | 1,419,103 | $315.45 |
Total share-based compensation expense related to RSUs was recorded as follows (in millions):
| 16 | United Therapeutics, a public benefit corporation |
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Cost of sales | $1.0 | $0.9 | $3.1 | $3.0 |
| Research and development | 10.4 | 8.0 | 25.6 | 22.3 |
| Selling, general, and administrative | 17.7 | 18.2 | 51.6 | 51.2 |
| Share-based compensation expense before taxes | 29.1 | 27.1 | 80.3 | 76.5 |
| Related income tax benefit | (5.3) | (4.2) | (13.6) | (12.3) |
| Share-based compensation expense, net of taxes | $23.8 | $22.9 | $66.7 | $64.2 |
As of September 30, 2026, unrecognized compensation cost related to the grant of RSUs was $210.4 million. Unvested outstanding RSUs as of September 30, 2026 had a weighted average remaining vesting period of 2.1 years.
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.
- 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):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Numerator: | ||||
| Net income | $258.6 | $338.7 | $866.5 | $970.4 |
| Denominator: | ||||
| Weighted average outstanding shares — basic | 42.7 | 43.8 | 42.9 | 44.6 |
| Effect of dilutive securities(1): | ||||
| Stock options, RSUs, and ESPP(2) | 2.6 | 3.5 | 3.2 | 3.5 |
| Weighted average shares — diluted(2) | 45.3 | 47.3 | 46.1 | 48.1 |
| Net income per common share: | ||||
| Basic | $6.06 | $7.73 | $20.20 | $21.76 |
| Diluted | $5.71 | $7.16 | $18.80 | $20.17 |
| Stock options and RSUs excluded from calculation(2) | 0.3 | 0.4 | 0.2 | 0.3 |
(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.
| Quarterly Report | 17 |
|---|
Share Repurchases
In July 2025, our Board approved a share repurchase program authorizing up to $1.0 billion in aggregate repurchases of our common stock. Subsequently, in March 2026, our Board approved a share repurchase program authorizing up to $2.0 billion in aggregate repurchases of our common stock. Under these share repurchase program authorizations, we executed a combination of accelerated share repurchases (ASRs) and Rule 10b5-1 trading plan repurchases.
The following table summarizes the terms of the share repurchase agreements that have been executed under the share repurchase authorizations (dollars in millions):
| Initial Delivery · Hedging Period · Final Settlement | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Agreement | Execution Date(1) | Amount | Shares Received | Value of Shares as % of Contract Value | Hedging Period Settlement Date | Shares Received | Settlement Date | Shares Received | Total Shares Received |
| August 2025 Uncollared ASR | August 1, 2025 | $500.0 | 1,274,296 | 75% | N/A | N/A | November 25, 2025 | 3,882 | 1,278,178 |
| August 2025 Collared ASR | August 1, 2025 | $500.0 | 849,531 | 50% | August 25, 2025 | 514,789 | January 26, 2026 | — | 1,364,320 |
| March 2026 Uncollared ASR | March 9, 2026 | $750.0 | 992,120 | 70% | N/A | N/A | June 23, 2026 | 378,936 | 1,371,056 |
| March 2026 Collared ASR | March 9, 2026 | $750.0 | 708,657 | 50% | March 30, 2026 | 463,682 | August 4, 2026 | 215,948 | 1,388,287 |
| Rule 10b5-1 trading plan | August - September 2026 | $22.4 | N/A | N/A | N/A | N/A | N/A | N/A | 45,070 |
| September 2026 ASR | September 8, 2026 | $477.6 | 719,376 | 75% | N/A | N/A | Fourth quarter of 2026 | N/A | 719,376 |
(1)With respect to the Rule 10b5-1 trading plan, this column indicates the period during which repurchases were made.
Under the terms of each ASR, we made an aggregate upfront payment to Citibank, N.A. (Citi) and received an initial delivery of shares of our common stock based on a percentage of the upfront payment and the closing price of our common stock on the date the ASR was executed. In collared ASRs, a collar provision established the minimum and maximum numbers of shares to be repurchased based on the results of an agreed-upon hedging period, and we received additional shares equal to the minimum number of shares to be repurchased (less the amount delivered in the initial delivery) upon completion of that hedging period. The number of additional shares received upon final settlement of each ASR is based on the difference between (1) the upfront payment divided by the average of the daily volume-weighted average price per share of our common stock during the applicable repurchase period, less a discount and subject to adjustments pursuant to the terms and conditions of the applicable agreement; and (2) the number of shares received in the initial delivery of shares, including any shares received at the completion of the hedging period under collared ASRs.
The upfront payment for the ASRs is initially accounted for intwo components, including an upfront treasury stock repurchase transaction, reflecting the cost of the initial delivery of shares, and an unsettled forward contract indexed to our common stock. The unsettled forward contract component under all completed ASRs was equity classified at inception and remained equity classified through their respective final settlement. The initial repurchase of our common stock under the ASRs was accounted for as a reduction to stockholders’ equity in our consolidated balance sheets. Shares of our common stock received under the ASRs reduced the outstanding shares used to calculate the weighted average common stock outstanding for basic and diluted earnings per common share.
As of September 30, 2026, the final settlement of the September 2026 ASR had not occurred and the related forward contract remained unsettled and equity classified. At the final settlement of the September 2026 ASR, we may be entitled to receive additional shares of our common stock, or, under certain limited circumstances, be required to make an additional cash payment to Citi or, if we so elect, deliver shares of our common stock to Citi. The final settlement of the September 2026 ASR is expected to occur in the fourth quarter of 2026, which is subject to acceleration at the option of Citi or extensions due to market disruption events or additional valuation periods required to calculate our obligation if necessary.
As of September 30, 2026, no amount remained available under the share repurchase programs authorized by our Board in July 2025 and March 2026. As of September 30, 2026 and December 31, 2025, we recorded an excise tax liability associated with these share repurchases of $6.8 million and $1.8 million, respectively.
On October 21, 2026, our Board approved a share repurchase program authorizing up to $2.0 billion in aggregate repurchases of our common stock (plus the amount of any customary contingent settlement obligations that may arise upon the expiration or early termination of an accelerated share repurchase contract), through October 21, 2027.
| 18 | United Therapeutics, a public benefit corporation |
- Income Taxes
Our effective income tax rate (ETR) for the nine months ended September 30, 2026 and 2025 was 19 percent and 24 percent, respectively. Our ETR for the nine months ended September 30, 2026 decreased compared to the same period in 2025 primarily due to increased excess tax benefits from share-based compensation, partially offset by nondeductible in-process research and development (IPR&D) expense related to the acquisition of Thymmune Therapeutics, Inc. (Thymmune). See Note 13—Asset Acquisition.
On July 4, 2025, the One Big Beautiful Bill Act (OBBBA) was enacted in the United States. The OBBBA includes provisions that allow both the immediate deduction of domestic research and experimental expenditures and the full expensing of the cost of certain qualifying assets in the year placed in service. The impacts of the OBBBA were reflected in our consolidated financial statements beginning in the period of enactment and continue to be reflected in the period ended September 30, 2026, resulting in decreases to both our deferred tax assets and cash tax liabilities. The OBBBA provisions did not have a material impact on our ETR for the nine-month period ended September 30, 2026.
We record interest and penalties related to uncertain tax positions as a component of income tax expense. As of September 30, 2026 and December 31, 2025, our unrecognized tax benefits, including related interest, were approximately $37.6 million and $28.7 million, respectively.
- 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, 2025, as filed with the SEC on February 25, 2026.
Our CODM is regularly provided with revenue and expense forecasts, including product development plans, to manage the operations of our operating segment. Our CODM monitors 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 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 sources of revenues were as follows (in millions):
| Three Months Ended September 30, | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026 · Tyvaso DPI · Nebulized Tyvaso · Remodulin(2) · Orenitram · Unituxin · Adcirca · Other · Total | |||||||||||||
| Total revenues | $378.5 | $125.3 | $122.0 | $145.0 | $52.3 | $4.5 | $4.9 | $832.5 | |||||
| Cost of sales(1) | 49.9 | 6.5 | 16.0 | 8.5 | 5.1 | 2.1 | 11.0 | 99.1 | |||||
| Gross profit (loss) | $328.6 | $118.8 | $106.0 | $136.5 | $47.2 | $2.4 | $(6.1) | $733.4 | |||||
| Total revenues | $336.2 | $141.8 | $125.9 | $131.1 | $47.9 | $9.7 | $6.9 | $799.5 | |||||
| Cost of sales(1) | 55.3 | 6.7 | 13.1 | 6.8 | 3.6 | 4.4 | 11.0 | 100.9 | |||||
| Gross profit (loss) | $280.9 | $135.1 | $112.8 | $124.3 | $44.3 | $5.3 | $(4.1) | $698.6 | |||||
| Nine Months Ended September 30, | |||||||||||||
| 2026 | Tyvaso DPI | Nebulized Tyvaso | Remodulin(2) | Orenitram | Unituxin | Adcirca | Other | Total | |||||
| Total revenues | $1,035.4 | $378.5 | $374.9 | $406.3 | $171.1 | $14.1 | $17.0 | $2,397.3 | |||||
| Cost of sales(1) | 184.2 | 24.0 | 49.5 | 22.0 | 12.1 | 6.1 | 34.1 | 332.0 | |||||
| Gross profit (loss) | $851.2 | $354.5 | $325.4 | $384.3 | $159.0 | $8.0 | $(17.1) | $2,065.3 | |||||
| Total revenues | $953.9 | $460.0 | $398.8 | $375.7 | $164.5 | $22.2 | $17.4 | $2,392.5 | |||||
| Cost of sales(1) | 151.9 | 20.8 | 41.2 | 21.8 | 11.6 | 9.7 | 24.0 | 281.0 | |||||
| Gross profit (loss) | $802.0 | $439.2 | $357.6 | $353.9 | $152.9 | $12.5 | $(6.6) | $2,111.5 | |||||
| Quarterly Report | 19 |
|---|
(1)During the three and nine months ended September 30, 2026, we recorded $11.4 million and $75.5 million of inventory reserve expense, respectively, as compared to $11.6 million and $27.1 million for the same periods in 2025. Tyvaso DPI inventory reserve expense accounts for $0.4 million and $47.5 million of the total inventory reserve expense recorded during the three and nine months ended September 30, 2026, respectively, as compared to $9.6 million and $20.4 million for the same periods in 2025. The Tyvaso DPI inventory reserve expense increased in the nine months ended September 30, 2026 primarily because we recorded estimated losses of $34.4 million related to a commercial supply agreement. This agreement is intended to provide us with sufficient inventory to meet the needs of our patients.
(2)Total revenues and cost of sales include sales of infusion devices, including the Remunity® and RemunityPRO® Pumps.
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):
| Three Months Ended September 30, | ||||||
|---|---|---|---|---|---|---|
| 2026 | 2025 | |||||
| U.S. | ROW | Total | U.S. | ROW | Total | |
| Net product sales: | ||||||
| Tyvaso DPI | $378.2 | $0.3 | $378.5 | $336.2 | $— | $336.2 |
| Nebulized Tyvaso | 118.0 | 7.3 | 125.3 | 133.9 | 7.9 | 141.8 |
| Total Tyvaso | 496.2 | 7.6 | 503.8 | 470.1 | 7.9 | 478.0 |
| Remodulin(1) | 108.5 | 13.5 | 122.0 | 110.7 | 15.2 | 125.9 |
| Orenitram | 145.0 | — | 145.0 | 131.1 | — | 131.1 |
| Unituxin | 49.9 | 2.4 | 52.3 | 46.5 | 1.4 | 47.9 |
| Adcirca | 4.5 | — | 4.5 | 9.7 | — | 9.7 |
| Other | 4.4 | 0.5 | 4.9 | 6.7 | 0.2 | 6.9 |
| Total revenues | $808.5 | $24.0 | $832.5 | $774.8 | $24.7 | $799.5 |
| Nine Months Ended September 30, | ||||||
| 2026 | 2025 | |||||
| U.S. | ROW | Total | U.S. | ROW | Total | |
| Net product sales: | ||||||
| Tyvaso DPI | $1,035.1 | $0.3 | $1,035.4 | $953.5 | $0.4 | $953.9 |
| Nebulized Tyvaso | 340.3 | 38.2 | 378.5 | 413.0 | 47.0 | 460.0 |
| Total Tyvaso | 1,375.4 | 38.5 | 1,413.9 | 1,366.5 | 47.4 | 1,413.9 |
| Remodulin(1) | 316.7 | 58.2 | 374.9 | 344.6 | 54.2 | 398.8 |
| Orenitram | 406.3 | — | 406.3 | 375.7 | — | 375.7 |
| Unituxin | 157.9 | 13.2 | 171.1 | 158.8 | 5.7 | 164.5 |
| Adcirca | 14.1 | — | 14.1 | 22.2 | — | 22.2 |
| Other | 15.9 | 1.1 | 17.0 | 16.4 | 1.0 | 17.4 |
| Total revenues | $2,286.3 | $111.0 | $2,397.3 | $2,284.2 | $108.3 | $2,392.5 |
(1) Net product sales include sales of infusion devices, including the Remunity and RemunityPRO Pumps.
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:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Distributor 1 | 50% | 52% | 50% | 52% |
| Distributor 2 | 40% | 37% | 37% | 36% |
- 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
| 20 | United Therapeutics, a public benefit corporation |
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.
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 November 1, 2024, the court entered a final judgment in favor of Sandoz, ordering us to pay to Sandoz (1) approximately $61.6 million in damages; (2) prejudgment interest in the amount of approximately $9.0 million; and (3) post-judgment interest. All parties appealed the final judgment, including the court’s March 30, 2022 summary judgment decision, to the U.S. Court of Appeals for the Third Circuit.
We accrued a liability of $71.1 million during 2024, an additional $3.0 million during 2025, and an additional $2.4 million during 2026 through the third quarter, reflecting, in the aggregate, the damages and prejudgment interest amounts awarded in the final judgment, as well as post-judgment interest accrued through September 30, 2026.
On October 7, 2026, the Third Circuit entered a decision (1) affirming the grant of summary judgment dismissing the antitrust and state unfair competition claims, citing our procompetitive conduct; (2) reversing the District Court’s finding that we breached our contract with Sandoz and remanding these claims to the District Court; and (3) reversing the District Court’s dismissal of the tortious interference claims, and remanding these claims to the District Court.
As more fully discussed below, on October 13, 2026, we entered into a settlement agreement with Liquidia Technologies, Inc. (Liquidia) (the Settlement Agreement) that provides for, among other terms, the settlement of all claims related to this matter in exchange for a $10.0 million payment by us to Liquidia. In exchange for this payment, Liquidia agreed to obtain any third-party approvals and consents, including from Sandoz, necessary to secure dismissal of the litigation. We made the $10.0 million payment to Liquidia on October 16, 2026. The case was dismissed by the District Court on October 28, 2026.
As a result of the Settlement Agreement, we recorded a $66.5 million reversal of the previously accrued liability, resulting in a remaining liability of $10.0 million as of September 30, 2026. We recorded the reversal within selling, general, and administrative in our consolidated statements of operations for the three and nine months ended September 30, 2026, and classified the remaining liability within other current liabilities in our consolidated balance sheet as of September 30, 2026.
Litigation with Liquidia Technologies, Inc.
Since March 2020, we have been engaged in litigation with Liquidia regarding its efforts to obtain FDA approval for Yutrepia®, a dry powder inhalation formulation of treprostinil. Liquidia received final approval from the FDA to market Yutrepia to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) in May 2025 and launched commercial sales in June 2025. The litigation included our patent infringement lawsuit against Liquidia, alleging infringement of U.S. Patent No. 11,826,327 (the’327 patent), which expires February 3, 2042, a lawsuit filed by Liquidia against us alleging that Tyvaso DPI infringes U.S. Patent No. 10,898,494 (the’494 patent), which expires May 5, 2037, and our lawsuit against Liquidia alleging that Yutrepia infringes U.S. Patent No. 11,357,782 (the’782 patent), which expires May 14, 2027.
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. The court scheduled trial to commence in January 2027.
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. That case is in its early stages, and the parties are currently engaged in discovery.
On September 30, 2026, the U.S. District Court for the District of Delaware ruled that Yutrepia infringestwo valid claims of the ‘327 patent. The claims of the ’327 patent generally cover improving exercise capacity in patients suffering from PH-ILD by inhaling treprostinil at specific dosages.
| Quarterly Report | 21 |
|---|
On October 13, 2026, we entered into the Settlement Agreement, under which we and Liquidia agreed to seek dismissal with prejudice of all of the foregoing actions (except that we may continue to pursue our claims against Dr. Roscigno). The parties also agreed to releases that become effective upon: (1) our receipt of the $185.0 million payment from Liquidia described below and Liquidia’s receipt of the $10.0 million payment from us described above; (2) our receipt of a Liquidia officer’s declaration confirming cessation of marketing, promotion, distribution, sales, and offers for sale of Yutrepia bearing the PH-ILD indication following regulatory approval of the label amendment; and (3) dismissal of the covered proceedings. Key terms of the Settlement Agreement include the following:
Liquidia agreed to pay us an aggregate of $330.4 million, consisting of: (1) $185.0 million, representing an estimate of damages for past sales of Yutrepia for PH-ILD, which we received on October 19, 2026; and (2) $145.4 million, representing an agreed estimate of damages for continuing sales of Yutrepia to PH-ILD patients after execution of the Settlement Agreement, payable intwo equal installments of $72.7 million each on or before February 1, 2027 and April 30, 2027. We expect to recognize a gain of $330.4 million within total other income, net in our consolidated statements of operations in the fourth quarter of 2026.
Liquidia agreed to immediately file with the FDA a supplement to its new drug application for Yutrepia to remove the PH-ILD indication and references to PH-ILD from the product’s labeling, and to diligently and urgently pursue FDA approval of that amendment. Such a supplement had already been filed by Liquidia on October 1, 2026, as a result of the District Court decision in the ’327 patent infringement case. Pending FDA approval of the label amendment, Liquidia may continue to sell Yutrepia under its current labeling subject to the Settlement Agreement, but Liquidia must immediately cease, desist, and terminate all activities related to the marketing, advertising, promotion, proactive medical education, and detailing of Yutrepia for the treatment of PH-ILD. Upon FDA approval of the label amendment, Liquidia must immediately cease all sales of Yutrepia bearing the PH-ILD indication.
Going forward, Liquidia agreed that it will only market, detail, and promote Yutrepia to healthcare practitioners who, to Liquidia’s knowledge, treat patients with PAH. Liquidia must send letters to healthcare practitioners advising that PH-ILD patients prescribed Yutrepia should be transitioned to an alternative therapy and to specified payers requesting immediate denial of prior authorization requests for Yutrepia for PH-ILD, and must instruct its sales force to no longer use marketing and detailing information containing any reference to PH-ILD or the INCREASE study. With immediate effect, Liquidia must include a mandatory certification with a checkbox that must be completed on any referral form, voucher application, prescription, or similar document for Yutrepia certifying that the patient has Group 1 PAH (or, in the future, any additional indication for which Yutrepia has received FDA approval), and require healthcare practitioners to certify the accuracy of the form. Liquidia must also send letters to all pharmacies carrying Yutrepia instructing them to include the mandatory Group 1 PAH certification on their own referral forms and to obtain verbal attestations from healthcare practitioners for pending referrals on old forms or forms lacking the certification. Liquidia must also terminate cohorts of its ASCENT clinical trial of Yutrepia that are studying PH-ILD as promptly as practicable, cease and desist from publishing any new data, and cease and desist disseminating already-published data, from cohorts of the ASCENT trial that are studying PH-ILD until after the expiration of the ’327 patent.
The parties have also agreed to certain covenants not to sue each other, and Liquidia agreed not to challenge certain of our patents subject to certain exceptions.
Unless earlier terminated, the Settlement Agreement expires on the later of (1) the expiration of our applicable patents containing a valid claim directed to PH-ILD; and (2) the expiration of the last valid claim of the applicable Liquidia patents. The applicable patents include our ’327 and ’782 patents and the ’494 patent for Liquidia, together with the related patents and patent applications specified in the Settlement Agreement. The labeling, promotional, and patent-challenge obligations described above expire on the earlier of the end of the term and the expiration of our applicable patents containing a valid claim directed to PH-ILD.
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.
| 22 | United Therapeutics, a public benefit corporation |
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, 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. On September 23, 2025, the court dismissed both lawsuits with prejudice. On October 20, 2025, Humana and United each appealed the court’s decision to the Appellate Court of Maryland, and those appeals are currently pending. Oral argument is scheduled for November 9, 2026.
We intend to continue to vigorously defend ourselves against the claims made in these lawsuits.
Litigation with Boehringer Ingelheim
Following the announcement of our successful TETON-1 clinical study of Nebulized Tyvaso in patients with idiopathic pulmonary fibrosis (IPF), a number of pharmaceutical sales representatives left Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer) to join our sales force to promote Nebulized Tyvaso for the treatment of PH-ILD, and to prepare for the eventual launch of Nebulized Tyvaso for the treatment of IPF following the anticipated FDA approval of this indication.
On July 17, 2026, Boehringer filed a complaint against us with the Court of Chancery of the State of Delaware, alleging that our hiring of former Boehringer sales representatives was part of a campaign to “raid” Boehringer’s interstitial lung disease sales force, and to procure and exploit Boehringer’s trade secrets. Boehringer’s complaint alleges misappropriation of trade secrets, aiding and abetting breaches of fiduciary duty of loyalty, and tortious interference with contracts. Boehringer seeks injunctive relief, monetary damages, and an award of attorneys’ fees and costs.
We believe we have meritorious defenses to these claims, and we intend to vigorously defend ourselves against the claims made in this lawsuit. Boehringer is one of only two pharmaceutical companies marketing branded IPF drugs, and controls two of the three branded IPF drugs approved in the United States. In expanding our sales force to address the PH-ILD market (which includes patients with underlying IPF), it is natural that Boehringer sales representatives would be among those qualified for these new positions at our company. We did not engage in a campaign to “raid” Boehringer’s sales force, and we have no interest in Boehringer’s alleged trade secrets. To the contrary, we explicitly instructed the former Boehringer employees not to use, disclose, or retain any such information.
We also believe that Boehringer has failed to adequately plead viable causes of action against us. On August 20, 2026, we filed a motion to dismiss the complaint and filed our opening brief in support of that motion on September 21, 2026. On September 11, 2026, we filed a motion to stay discovery that Boehringer had initiated on August 7, 2026. On September 25,
| Quarterly Report | 23 |
|---|
2026, before responding to our motion to dismiss, Boehringer filed its opposition to our motion to stay discovery, and simultaneously filed a motion to expedite discovery, more than two months after initiating the lawsuit and seven weeks after serving discovery. On October 5, 2026, the court denied both Boehringer’s motion to expedite discovery and our motion to stay discovery and on October 22, 2026, Boehringer filed an amended complaint, and the parties are engaged in discovery.
- Asset Acquisition
On July 1, 2026, we acquired all outstanding equity of Thymmune, a preclinical-stage company developing scalable, regenerative thymic cell therapies for the potential treatment of post-transplant organ tolerance, immunodeficiencies, and autoimmune diseases, for an upfront cash payment of approximately $140.0 million, subject to customary purchase price adjustments. The consideration for the acquisition also includes potential earnout consideration of up to $160.0 million, payable in cash to former Thymmune equityholders, upon the timely achievement of specified clinical and regulatory milestones for Thymmune's lead program, THY-100, consisting of (1) up to $60.0 million if the first patient is dosed in the initial human clinical trial on or before December 31, 2028; and (2) $100.0 million if the FDA accepts a Biologics License Application for review on or before December 31, 2031.
We accounted for this transaction as an asset acquisition, as substantially all of the fair value of the acquired assets was concentrated in a single IPR&D asset. We allocated $133.6 million of the purchase price to the IPR&D asset and, because the IPR&D asset had no alternative future use, expensed that amount immediately toresearch and development in our consolidated statements of operations for the three and nine months ended September 30, 2026. Because we accounted for this transaction as an asset acquisition, we will record the associated contingent consideration when the contingency is resolved and the consideration is paid or becomes payable. The amount allocated to the IPR&D asset is not deductible for tax purposes and was capitalized into the tax basis of the equity we acquired.
- Subsequent Event
We entered into an Exclusive License Agreement, dated November 15, 2018 (the License Agreement), with Arena Pharmaceuticals, Inc., a subsidiary of Pfizer Inc. (Arena). The License Agreement granted to us perpetual, irrevocable, and exclusive rights to develop, manufacture, and commercialize ralinepag in exchange for (1) an upfront payment of $800.0 million paid on January 24, 2019; (2) a one-time milestone payment of $250.0 million for the first, if any, marketing approval we receive in the United States for an inhaled version of ralinepag to treat PAH; (3) a one-time milestone payment of $150.0 million for the first, if any, marketing approval we receive in any of Japan, France, Italy, the United Kingdom, Spain, or Germany for an oral version of ralinepag to treat any indication; and (4) low double-digit, tiered royalties on net sales of any pharmaceutical product containing ralinepag as an active ingredient, subject to certain adjustments for third-party license payments.
On November 3, 2026, we entered into an amendment to the License Agreement and made a lump-sum payment of $525.0 million to Arena in exchange for eliminating our obligation to pay royalties on future net sales of any pharmaceutical product containing ralinepag as an active ingredient (the Royalty Substitution Payment), including, if approved, ralinepag extended-release tablets and ralinepag DPI. We expect to recognize an expense of $525.0 million within research and developmentin our consolidated statements of operations in the fourth quarter of 2026 in connection with the Royalty Substitution Payment. Milestone payment obligations pursuant to the License Agreement remain in place.
| 24 | United Therapeutics, a public benefit corporation |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.