Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2024 | Jul. 24, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
Document Transition Report | false | |
Entity File Number | 0-26301 | |
Entity Registrant Name | United Therapeutics Corporation | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 52-1984749 | |
Entity Address, Address Line One | 1000 Spring Street | |
Entity Address, City or Town | Silver Spring | |
Entity Address, State or Province | MD | |
Entity Address, Postal Zip Code | 20910 | |
City Area Code | 301 | |
Local Phone Number | 608-9292 | |
Security 12b Title | Common Stock, par value $0.01 per share | |
Trading Symbol | UTHR | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 44,491,176 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001082554 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Millions | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 1,355.7 | $ 1,207.7 |
Marketable investments | 1,615.8 | 1,786.4 |
Accounts receivable, no allowance for 2024 and 2023 | 290.7 | 278.9 |
Inventories, net | 136.5 | 111.8 |
Other current assets | 220.8 | 166.2 |
Total current assets | 3,619.5 | 3,551 |
Marketable investments | 1,330.4 | 1,909.8 |
Goodwill and other intangible assets, net | 115.2 | 114.2 |
Property, plant, and equipment, net | 1,094.6 | 1,045.4 |
Deferred tax assets, net | 395.6 | 394.8 |
Other non-current assets | 167.9 | 151.8 |
Total assets | 6,723.2 | 7,167 |
Current liabilities: | ||
Accounts payable and accrued expenses | 325.3 | 298 |
Line of credit (current) | 400 | 400 |
Share tracking awards plan | 29.2 | 35.4 |
Other current liabilities | 77.8 | 71 |
Total current liabilities | 832.3 | 804.4 |
Line of credit (non-current) | 100 | 300 |
Other non-current liabilities | 93.7 | 77.8 |
Total liabilities | 1,026 | 1,182.2 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, par value $.01, 10,000,000 shares authorized, no shares issued | 0 | 0 |
Common stock, par value $.01, 245,000,000 shares authorized, 74,497,837 and 73,659,761 shares issued, and 44,421,650 and 47,040,545 shares outstanding as of June 30, 2024 and December 31, 2023, respectively | 0.7 | 0.7 |
Additional paid-in capital | 2,543.1 | 2,549 |
Accumulated other comprehensive loss | (14.9) | (12.8) |
Treasury stock, 30,076,187 and $26,619,216 shares as of June 30, 2024 and December 31, 2023, respectively | (3,443.5) | (2,579.2) |
Retained earnings | 6,611.8 | 6,027.1 |
Total stockholders’ equity | 5,697.2 | 5,984.8 |
Total liabilities and stockholders’ equity | $ 6,723.2 | $ 7,167 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Accounts receivable, allowance | $ 0 | $ 0 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 245,000,000 | 245,000,000 |
Common stock, shares issued (in shares) | 74,497,837 | 73,659,761 |
Common stock, shares outstanding (in shares) | 44,421,650 | 47,040,545 |
Treasury stock (in shares) | 30,076,187 | 26,619,216 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Millions, $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Income Statement [Abstract] | ||||
Total revenues | $ 714.9 | $ 596.5 | $ 1,392.6 | $ 1,103.4 |
Operating expenses: | ||||
Cost of sales | 77.8 | 64.1 | 150.7 | 116.4 |
Research and development | 139.6 | 89 | 243.7 | 171.9 |
Selling, general, and administrative | 177.6 | 130 | 322 | 217.3 |
Total operating expenses | 395 | 283.1 | 716.4 | 505.6 |
Operating income | 319.9 | 313.4 | 676.2 | 597.8 |
Interest income | 46.2 | 37.2 | 100 | 66.4 |
Interest expense | (11.6) | (14.8) | (24.9) | (28.6) |
Other income (expense), net | 0.8 | (0.6) | 2.6 | (8.5) |
Total other income, net | 35.4 | 21.8 | 77.7 | 29.3 |
Income before income taxes | 355.3 | 335.2 | 753.9 | 627.1 |
Income tax expense | (77.2) | (76) | (169.2) | (127) |
Net income | $ 278.1 | $ 259.2 | $ 584.7 | $ 500.1 |
Net income per common share: | ||||
Basic (in dollars per share) | $ 6.26 | $ 5.53 | $ 12.79 | $ 10.73 |
Diluted (in dollars per share) | $ 5.85 | $ 5.24 | $ 12.03 | $ 10.08 |
Weighted average number of common shares outstanding: | ||||
Basic (in shares) | 44.4 | 46.9 | 45.7 | 46.6 |
Diluted (in shares) | 47.5 | 49.5 | 48.6 | 49.6 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Comprehensive income: | ||||
Net income | $ 278.1 | $ 259.2 | $ 584.7 | $ 500.1 |
Other comprehensive income (loss): | ||||
Foreign currency translation loss included in net income | 0 | 0 | 2.4 | 0 |
Defined benefit pension plan: | ||||
Actuarial loss arising during period, net of tax | 0 | 0 | (0.5) | (0.9) |
Actuarial gain and prior service cost included in net periodic pension cost, net of tax | (1.1) | (0.8) | (2.3) | (3.1) |
Total defined benefit pension plan, net of tax | (1.1) | (0.8) | (2.8) | (4) |
Available-for-sale debt securities: | ||||
Unrealized gain (loss) arising during period, net of tax | 1.8 | (11) | (2.8) | 8.9 |
Realized loss included in net income, net of tax | 0 | 0 | 1.1 | 0 |
Total gain (loss) on available-for-sale debt securities, net of tax | 1.8 | (11) | (1.7) | 8.9 |
Other comprehensive income (loss), net of tax | 0.7 | (11.8) | (2.1) | 4.9 |
Comprehensive income | $ 278.8 | $ 247.4 | $ 582.6 | $ 505 |
Consolidated Statements of Co_2
Consolidated Statements of Comprehensive Income (Parenthetical) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Statement of Comprehensive Income [Abstract] | ||||
Tax (benefit) expense in other comprehensive income for the defined benefit pension plan | $ (0.1) | $ (0.1) | $ (0.2) | $ (0.6) |
Tax (benefit) expense in other comprehensive income for available-for-sale debt securities | $ 0.6 | $ (3.6) | $ (0.6) | $ 2.7 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Millions | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Treasury Stock | Retained Earnings |
Beginning Balance (in shares) at Dec. 31, 2022 | 72,700,000 | |||||
Beginning Balance at Dec. 31, 2022 | $ 4,796.7 | $ 0.7 | $ 2,388.4 | $ (55.5) | $ (2,579.2) | $ 5,042.3 |
Increase (Decrease) in Stockholders' Equity | ||||||
Net income | 500.1 | 500.1 | ||||
Foreign currency translation loss | 0 | |||||
Unrealized gain (loss) on available-for-sale debt securities | 8.9 | 8.9 | ||||
Defined benefit pension plan | (4) | (4) | ||||
Shares issued under ESPP | 3.4 | 3.4 | ||||
Restricted stock units (RSUs) withheld for taxes | (13.5) | (13.5) | ||||
Common stock issued for RSUs vested (in shares) | 100,000 | |||||
Exercise of stock options (in shares) | 700,000 | |||||
Exercise of stock options | 86.1 | 86.1 | ||||
Share-based compensation | 33.3 | 33.3 | ||||
Ending Balance (in shares) at Jun. 30, 2023 | 73,500,000 | |||||
Ending Balance at Jun. 30, 2023 | 5,411 | $ 0.7 | 2,497.7 | (50.6) | (2,579.2) | 5,542.4 |
Beginning Balance (in shares) at Mar. 31, 2023 | 73,300,000 | |||||
Beginning Balance at Mar. 31, 2023 | 5,123.2 | $ 0.7 | 2,457.3 | (38.8) | (2,579.2) | 5,283.2 |
Increase (Decrease) in Stockholders' Equity | ||||||
Net income | 259.2 | 259.2 | ||||
Foreign currency translation loss | 0 | |||||
Unrealized gain (loss) on available-for-sale debt securities | (11) | (11) | ||||
Defined benefit pension plan | (0.8) | (0.8) | ||||
Exercise of stock options (in shares) | 200,000 | |||||
Exercise of stock options | 24.7 | 24.7 | ||||
Share-based compensation | 15.7 | 15.7 | ||||
Ending Balance (in shares) at Jun. 30, 2023 | 73,500,000 | |||||
Ending Balance at Jun. 30, 2023 | $ 5,411 | $ 0.7 | 2,497.7 | (50.6) | (2,579.2) | 5,542.4 |
Beginning Balance (in shares) at Dec. 31, 2023 | 73,659,761 | 73,700,000 | ||||
Beginning Balance at Dec. 31, 2023 | $ 5,984.8 | $ 0.7 | 2,549 | (12.8) | (2,579.2) | 6,027.1 |
Increase (Decrease) in Stockholders' Equity | ||||||
Net income | 584.7 | 584.7 | ||||
Foreign currency translation loss | 2.4 | 2.4 | ||||
Unrealized gain (loss) on available-for-sale debt securities | (1.7) | (1.7) | ||||
Defined benefit pension plan | (2.8) | (2.8) | ||||
Shares issued under ESPP | 3.9 | 3.9 | ||||
Restricted stock units (RSUs) withheld for taxes | (11.5) | (11.5) | ||||
Share repurchase | (1,000) | (142.1) | (857.9) | |||
Excise tax on net share repurchase | (6.4) | (6.4) | ||||
Common stock issued for RSUs vested (in shares) | 100,000 | |||||
Exercise of stock options (in shares) | 700,000 | |||||
Exercise of stock options | 94.3 | 94.3 | ||||
Share-based compensation | $ 49.5 | 49.5 | ||||
Ending Balance (in shares) at Jun. 30, 2024 | 74,497,837 | 74,500,000 | ||||
Ending Balance at Jun. 30, 2024 | $ 5,697.2 | $ 0.7 | 2,543.1 | (14.9) | (3,443.5) | 6,611.8 |
Beginning Balance (in shares) at Mar. 31, 2024 | 74,100,000 | |||||
Beginning Balance at Mar. 31, 2024 | 5,338.1 | $ 0.7 | 2,405.4 | (15.6) | (3,386.1) | 6,333.7 |
Increase (Decrease) in Stockholders' Equity | ||||||
Net income | 278.1 | 278.1 | ||||
Foreign currency translation loss | 0 | |||||
Unrealized gain (loss) on available-for-sale debt securities | 1.8 | 1.8 | ||||
Defined benefit pension plan | (1.1) | (1.1) | ||||
Restricted stock units (RSUs) withheld for taxes | (0.1) | (0.1) | ||||
Share repurchase | 0 | 57.9 | (57.9) | |||
Excise tax on net share repurchase | 0.5 | 0.5 | ||||
Exercise of stock options (in shares) | 400,000 | |||||
Exercise of stock options | 52.1 | 52.1 | ||||
Share-based compensation | $ 27.8 | 27.8 | ||||
Ending Balance (in shares) at Jun. 30, 2024 | 74,497,837 | 74,500,000 | ||||
Ending Balance at Jun. 30, 2024 | $ 5,697.2 | $ 0.7 | $ 2,543.1 | $ (14.9) | $ (3,443.5) | $ 6,611.8 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Millions | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Cash flows from operating activities: | ||
Net income | $ 584.7 | $ 500.1 |
Adjustments to reconcile net income to net cash provided by operating activities: | ||
Depreciation and amortization | 33.7 | 26.2 |
Share-based compensation expense | 75.3 | 1.4 |
Impairment of property, plant, and equipment | 0 | 3.6 |
Other | (16) | 1.9 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (11.8) | (52.2) |
Inventories | (24) | (3.5) |
Accounts payable and accrued expenses | 27.7 | 40.8 |
Other assets and liabilities | (60.9) | (37.2) |
Net cash provided by operating activities | 608.7 | 481.1 |
Cash flows from investing activities: | ||
Purchases of property, plant, and equipment | (83.3) | (86) |
Deposits | (4.7) | (3.7) |
Purchases of available-for-sale debt securities | (759.8) | (1,561.5) |
Maturities of available-for-sale debt securities | 671.8 | 1,202.9 |
Sales of available-for-sale debt securities | 831.8 | 0 |
Purchase of investment in privately-held company | (0.5) | 0 |
Net cash provided by (used in) investing activities | 655.3 | (448.3) |
Cash flows from financing activities: | ||
Payments to repurchase common stock | (1,000) | 0 |
Repayment of line of credit | (200) | 0 |
Payments of debt issuance costs | (2.7) | (2.7) |
Proceeds from the exercise of stock options | 94.3 | 86.1 |
Proceeds from the issuance of stock under ESPP | 3.9 | 3.4 |
RSUs withheld for taxes | (11.5) | (13.5) |
Net cash (used in) provided by financing activities | (1,116) | 73.3 |
Net increase in cash and cash equivalents | 148 | 106.1 |
Cash and cash equivalents, beginning of period | 1,207.7 | 961.2 |
Cash and cash equivalents, end of period | 1,355.7 | 1,067.3 |
Supplemental cash flow information: | ||
Cash paid for interest | 23.4 | 27.2 |
Cash paid for income taxes | 212 | 147.5 |
Non-cash investing and financing activities: | ||
Non-cash additions to property, plant, and equipment | 17.9 | 32.7 |
Measurement period adjustment to purchase price | 1.4 | 0 |
Excise tax on net share repurchase | 6.4 | 0 |
Receivable from maturity of available-for-sale debt securities | $ 45 | $ 0 |
Organization and Business Descr
Organization and Business Description | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Business Description | 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 ( PBC ), with the express public benefit purpose to 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. 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
Basis of Presentation | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | 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, 2023, as filed with the SEC on February 21, 2024. 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, 2024 and December 31, 2023, our statements of operations, comprehensive income, and stockholders’ equity for the three- and six-month periods ended June 30, 2024 and 2023, and our statements of cash flows for the six-month periods ended June 30, 2024 and 2023. Interim results are not necessarily indicative of results for an entire year. Recently Issued Accounting Standards Accounting Standards Adopted During the Period None. Accounting Standards Not Yet Adopted In October 2023, the FASB issued Accounting Standards Update ( ASU ) 2023-06, Disclosure Improvements, which incorporates certain existing or incremental disclosure and presentation requirements of SEC Regulation S-X and Regulation S-K into the FASB Accounting Standards Codification ( Codification ). The amendments in the ASU are expected to clarify or improve disclosure and presentation requirements of a variety of Codification topics and to align the requirements in the Codification with the SEC’s regulations. The effective date for each amendment in the ASU will be the date on which the SEC’s removal of the related disclosure requirement from Regulation S-X or Regulation S-K becomes effective, or if the SEC has not removed the related requirement by June 30, 2027, the applicable amendment will be removed from the Codification and will not become effective for any entity. Early adoption is prohibited. We are evaluating the impact of adopting this guidance on our consolidated financial statements. In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which is intended to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant expenses. This ASU requires disclosures to include significant segment expenses that are regularly provided to the chief operating decision maker ( CODM ), a description of other segment items by reportable segment, and any additional measures of a segment profit or loss used by the CODM when deciding how to allocate resources. This ASU also requires all annual disclosures currently required by Topic 280 to be included in interim period disclosures. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, although early adoption is permitted. The guidance requires retrospective application to all prior periods presented in the financial statements. We are evaluating the impact of adopting this guidance on our consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which enhances the required disclosures primarily related to the 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 annual periods beginning after December 15, 2024, although early adoption is permitted. We are evaluating the impact of adopting this guidance on our consolidated financial statements. |
Investments
Investments | 6 Months Ended |
Jun. 30, 2024 | |
Investments [Abstract] | |
Investments | 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 of accumulated other comprehensive loss in stockholders’ equity, until realized. Available-for-sale debt securities consisted of the following (in millions): As of June 30, 2024 Amortized Gross Gross Fair U.S. government and agency securities $ 2,386.7 $ 0.4 $ (14.3) $ 2,372.8 Corporate debt securities 582.7 0.4 (3.4) 579.7 Total (1) $ 2,969.4 $ 0.8 $ (17.7) $ 2,952.5 Reported under the following captions in our consolidated balance sheets: Cash and cash equivalents $ 27.2 Current marketable investments 1,594.9 Non-current marketable investments 1,330.4 Total (1) $ 2,952.5 As of December 31, 2023 Amortized Gross Gross Fair U.S. government and agency securities $ 3,044.5 $ 5.3 $ (17.2) $ 3,032.6 Corporate debt securities 727.2 2.1 (4.7) 724.6 Total (2) $ 3,771.7 $ 7.4 $ (21.9) $ 3,757.2 Reported under the following captions in our consolidated balance sheets: Cash and cash equivalents $ 75.9 Current marketable investments 1,771.5 Non-current marketable investments 1,909.8 Total (2) $ 3,757.2 (1) Total excludes $45.0 million related to available-for-sale debt securities that matured on June 30, 2024, although cash proceeds were not received until July 1, 2024. We recorded the $45.0 million receivable within other current assets in our consolidated balance sheets as of June 30, 2024. (2) Total excludes $21.0 million related to available-for-sale debt securities that matured on December 31, 2023, although cash proceeds were not received until January 2, 2024. We recorded the $21.0 million receivable within other current assets in our consolidated balance sheets as of December 31, 2023. 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, 2024 and December 31, 2023, 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 June 30, 2024 Fair Value Gross Fair Value Gross Fair Value Gross U.S. government and agency securities $ 1,145.8 $ (4.9) $ 1,114.6 $ (9.4) $ 2,260.4 $ (14.3) Corporate debt securities 289.0 (1.4) 154.6 (2.0) 443.6 (3.4) Total $ 1,434.8 $ (6.3) $ 1,269.2 $ (11.4) $ 2,704.0 $ (17.7) Less than 12 months 12 months or longer Total As of December 31, 2023 Fair Value Gross Fair Value Gross Fair Value Gross U.S. government and agency securities $ 1,101.8 $ (4.4) $ 838.1 $ (12.8) $ 1,939.9 $ (17.2) Corporate debt securities 209.4 (0.5) 284.1 (4.2) 493.5 (4.7) Total $ 1,311.2 $ (4.9) $ 1,122.2 $ (17.0) $ 2,433.4 $ (21.9) As of June 30, 2024 and December 31, 2023, we held 541 and 385 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, 2024 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 were no impairments due to credit loss on our available-for-sale debt securities during the three and six months ended June 30, 2024 and 2023. 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 June 30, 2024 Amortized Cost Fair Value Due within one year $ 1,632.2 $ 1,622.1 Due in one to three years 1,337.2 1,330.4 Total $ 2,969.4 $ 2,952.5 Investments in Equity Securities with Readily Determinable Fair Values We held investments in equity securities with readily determinable fair values, in the aggregate, of $20.9 million and $14.9 million as of June 30, 2024 and December 31, 2023, 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 (expense), net . See Note 4— Fair Value Measurements . Investments in Privately-Held Companies As of June 30, 2024 and December 31, 2023, we maintained non-controlling equity investments in privately-held companies of $29.0 million and $28.5 million, respectively, 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 . |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 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 June 30, 2024 Level 1 Level 2 Level 3 Balance Assets Money market funds (1) $ 104.2 $ — $ — $ 104.2 Time deposits (1) 343.9 — — 343.9 U.S. government and agency securities (2) — 2,372.8 — 2,372.8 Corporate debt securities (2) — 579.7 — 579.7 Equity securities (3) 20.9 — — 20.9 Total assets $ 469.0 $ 2,952.5 $ — $ 3,421.5 Liabilities Contingent consideration (4) — — 22.6 22.6 Total liabilities $ — $ — $ 22.6 $ 22.6 As of December 31, 2023 Level 1 Level 2 Level 3 Balance Assets Money market funds (1) $ 408.5 $ — $ — $ 408.5 Time deposits (1) 126.4 — — 126.4 U.S. government and agency securities (2) — 3,032.6 — 3,032.6 Corporate debt securities (2) — 724.6 — 724.6 Equity securities (3) 14.9 — — 14.9 Total assets $ 549.8 $ 3,757.2 $ — $ 4,307.0 Liabilities Contingent consideration (4) — — 21.1 21.1 Total liabilities $ — $ — $ 21.1 $ 21.1 (1) Included in cash and cash equivalents in our consolidated balance sheets. (2) Included in cash and cash equivalents and current and non-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 in current 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 six months ended June 30, 2024 we recognized $0.4 million and $6.0 million of net unrealized gains, respectively, on these securities. During the three and six months ended June 30, 2023, we recognized $1.6 million and $10.4 million of net unrealized losses, respectively, on these securities. We recorded these gains and losses in our consolidated statements of operations within other income (expense), net . See Note 3— Investments—Marketable Investments—Investments in Equity Securities with Readily Determinable Fair Values . (4) Included in other current liabilities and other non-current liabilities in our consolidated balance sheets. The fair value of our contingent consideration obligations has been 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 $1.5 million during the six months ended June 30, 2024, of which $1.4 million was a measurement period adjustment related to our acquisition of Miromatrix Medical Inc. ( Miromatrix ) in 2023, with the remaining change recorded within research and development in our consolidated statements of operations. Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, accounts receivable, and accounts 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. |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Inventories | 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): June 30, 2024 December 31, 2023 Raw materials $ 22.0 $ 21.7 Work-in-progress 34.4 34.4 Finished goods 80.1 55.7 Total inventories $ 136.5 $ 111.8 |
Property, Plant, and Equipment
Property, Plant, and Equipment | 6 Months Ended |
Jun. 30, 2024 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant, and Equipment | Property, Plant, and Equipment Property, plant, and equipment consists of the following (in millions): June 30, 2024 December 31, 2023 Land and land improvements $ 152.9 $ 148.0 Buildings, building improvements, and leasehold improvements 851.5 685.3 Buildings under construction 110.1 259.1 Furniture, equipment, and vehicles 441.4 381.2 Subtotal 1,555.9 1,473.6 Less—accumulated depreciation (461.3) (428.2) Property, plant, and equipment, net $ 1,094.6 $ 1,045.4 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Debt | Debt Credit Agreement In March 2022, we entered into a credit agreement (the 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: (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 (which facilities may, at our request, be increased by up to $500.0 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 Credit Agreement, in March 2024, we extended the maturity date of the Credit Agreement by one year, to March 2029. At our option, amounts borrowed under the 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 Credit Agreement). To date, we have elected to calculate interest on the outstanding balance at an adjusted Term SOFR plus an applicable margin. On March 31, 2022, we borrowed $800.0 million under the Credit Agreement, and used the funds to repay outstanding indebtedness under a prior credit agreement. As of December 31, 2023, our outstanding aggregate principal balance under the Credit Agreement was $700.0 million. During the three and six months ended June 30, 2024, we paid down $100.0 million and $200.0 million of our balance under the Credit Agreement, respectively, which brought our aggregate outstanding balance down to $500.0 million as of June 30, 2024. Although our credit facility matures in 2029, we classified $400.0 million of the outstanding balance as a current liability on our consolidated balance sheet as of June 30, 2024, as we intend to repay this amount within one year. The Credit Agreement contains customary events of default and customary affirmative and negative covenants. As of June 30, 2024, we were in compliance with these covenants. The interest expense reported in our consolidated statements of operations for the six months ended June 30, 2024 and 2023 is related to our borrowings under the Credit Agreement. |
Share-Based Compensation
Share-Based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | Share-Based Compensation As of June 30, 2024, we have two shareholder-approved equity incentive plans: the United Therapeutics Corporation Amended and Restated Equity Incentive Plan (the 1999 Plan ) and the United Therapeutics Corporation Amended and Restated 2015 Stock Incentive Plan (the 2015 Plan ). The 2015 Plan provides for the issuance of up to 13,820,000 shares of our common stock pursuant to awards granted under the 2015 Plan, which includes 1,320,000 shares that were added pursuant to an amendment and restatement of the 2015 Plan approved by our shareholders in June 2024. No further awards will be granted under the 1999 Plan. We also have one 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 Options and RSUs below for additional information regarding these equity-based awards. During the six months ended June 30, 2024 and 2023, we issued stock options and RSUs to certain executives with vesting conditions tied to the achievement of specified performance criteria through the end of 2026 and 2025, respectively. 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 refer to awards outstanding under the STAP as STAP awards . See the section entitled STAP Awards below for additional information regarding STAP awards. We discontinued the issuance of STAP awards in June 2015. 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): Three Months Ended Six Months Ended 2024 2023 2024 2023 Stock options $ 8.1 $ 1.6 $ 13.8 $ 6.5 RSUs 19.2 13.6 34.7 25.8 STAP awards 21.9 (1.9) 25.8 (31.9) ESPP 0.5 0.5 1.0 1.0 Total share-based compensation expense before tax $ 49.7 $ 13.8 $ 75.3 $ 1.4 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, 2024 and 2023, in addition to time-based stock options, we granted 0.5 million and 0.4 million performance-based stock options with a total grant date fair value of $50.2 million and $35.6 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, 2024 we recorded $7.1 million and $11.9 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 $1.0 million and $1.2 million for the same periods in 2023. 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, 2024 and 2023: June 30, 2024 June 30, 2023 Expected term of awards (in years) 6.5 6.5 Expected volatility 31.6 % 31.4 % Risk-free interest rate 4.3 % 3.6 % Expected dividend yield — % — % A summary of the activity and status of stock options under our equity incentive plans during the six-month period ended June 30, 2024 is presented below: Number of Weighted Weighted Aggregate Outstanding as of January 1, 2024 6,213,853 $ 136.60 Granted 535,797 236.02 Exercised (725,416) 129.89 Forfeited — — Outstanding as of June 30, 2024 6,024,234 $ 146.25 3.9 $ 1,038.0 Exercisable as of June 30, 2024 5,029,432 $ 130.15 2.8 $ 947.6 Unvested as of June 30, 2024 994,802 $ 227.64 9.3 $ 90.4 The weighted average fair value of a stock option granted during each of the six-month periods ended June 30, 2024 and June 30, 2023 was $97.24 and $85.52, respectively. These stock options have an aggregate grant date fair value of $52.1 million and $36.3 million, respectively. The total grant date fair value of stock options that vested during the six-month periods ended June 30, 2024 and June 30, 2023 was $0.9 million and $52.9 million, respectively. Total share-based compensation expense related to stock options is recorded as follows (in millions): Three Months Ended Six Months Ended 2024 2023 2024 2023 Cost of sales $ — $ — $ — $ — Research and development 0.1 — 0.2 0.1 Selling, general, and administrative 8.0 1.6 13.6 6.4 Share-based compensation expense before taxes 8.1 1.6 13.8 6.5 Related income tax benefit (0.3) (0.1) (0.5) (0.3) Share-based compensation expense, net of taxes $ 7.8 $ 1.5 $ 13.3 $ 6.2 As of June 30, 2024, unrecognized compensation cost related to stock options was $68.0 million. Unvested outstanding stock options as of June 30, 2024 had a weighted average remaining vesting period of 2.4 years. Stock option exercise data is summarized below (dollars in millions): Three Months Ended Six Months Ended 2024 2023 2024 2023 Number of options exercised 398,149 214,244 725,416 753,344 Cash received $ 52.1 $ 24.7 $ 94.3 $ 86.1 Total intrinsic value of options exercised $ 52.3 $ 23.8 $ 88.0 $ 95.4 RSUs Each RSU entitles the recipient to one 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, 2024 and 2023, in addition to time-based RSUs, we granted 0.2 million and 0.2 million performance-based RSUs with a total grant date fair value of $47.5 million and $32.2 million, respectively, 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, 2024, we recorded $5.1 million and $7.2 million of share-based compensation expense, respectively, related to performance-based RSUs, calculated based on the assumed levels of performance achievement as compared to $0.9 million and $1.1 million for the same periods in 2023. A summary of the activity with respect to, and status of, RSUs during the six-month period ended June 30, 2024 is presented below: Number of Weighted Unvested as of January 1, 2024 964,759 $ 210.35 Granted 396,352 235.84 Vested (140,382) 186.67 Forfeited (11,958) 214.60 Unvested as of June 30, 2024 1,208,771 $ 221.41 Total share-based compensation expense related to RSUs is recorded as follows (in millions): Three Months Ended Six Months Ended 2024 2023 2024 2023 Cost of sales $ 1.1 $ 1.0 $ 2.0 $ 2.0 Research and development 5.8 5.1 11.4 9.8 Selling, general, and administrative 12.3 7.5 21.3 14.0 Share-based compensation expense before taxes 19.2 13.6 34.7 25.8 Related income tax benefit (3.5) (3.2) (6.8) (6.1) Share-based compensation expense, net of taxes $ 15.7 $ 10.4 $ 27.9 $ 19.7 As of June 30, 2024, unrecognized compensation cost related to the grant of RSUs was $185.4 million. Unvested outstanding RSUs as of June 30, 2024 had a weighted average remaining vesting period of 2.7 years. STAP Awards STAP awards convey the right to receive in cash an amount equal to the appreciation of our common stock, which is measured as the increase in the closing price of our common stock between the dates of grant and exercise. STAP awards expire on the ten The aggregate liability balance associated with outstanding STAP awards was $29.2 million and $35.4 million as of June 30, 2024 and December 31, 2023, respectively, all of which was classified as a current liability in our consolidated balance sheets. Estimating the fair value of STAP awards requires the use of certain inputs that can materially impact the determination of fair value and the amount of compensation expense we recognize. Inputs used in estimating fair value include the price of our common stock, the expected volatility of the price of our common stock, the risk-free interest rate, the expected term of STAP awards, and the expected dividend yield. The fair value of the STAP awards is measured at the end of each financial reporting period because the awards are settled in cash. The table below includes the weighted average assumptions used to measure the fair value of the outstanding STAP awards: June 30, 2024 June 30, 2023 Expected term of awards (in years) 0.7 0.8 Expected volatility 29.4 % 26.1 % Risk-free interest rate 5.2 % 5.4 % Expected dividend yield — % — % The closing price of our common stock was $318.55 and $220.75 on June 30, 2024 and June 30, 2023, respectively. The closing price of our common stock was $219.89 on December 31, 2023. A summary of the activity and status of STAP awards during the six-month period ended June 30, 2024 is presented below: Number of Weighted Weighted Aggregate Outstanding as of January 1, 2024 443,058 $ 149.21 Granted — — Exercised (273,206) 143.31 Forfeited — — Outstanding as of June 30, 2024 169,852 $ 158.70 0.7 $ 27.2 Exercisable as of June 30, 2024 169,852 $ 158.70 0.7 $ 27.2 Unvested as of June 30, 2024 — $ — — $ — Share-based compensation expense (benefit) recognized in connection with STAP awards is as follows (in millions): Three Months Ended Six Months Ended 2024 2023 2024 2023 Cost of sales $ 0.8 $ (0.1) $ 1.0 $ (1.5) Research and development 2.5 (0.4) 3.0 (4.1) Selling, general, and administrative 18.6 (1.4) 21.8 (26.3) Share-based compensation expense (benefit) before taxes 21.9 (1.9) 25.8 (31.9) Related income tax (benefit) expense (2.9) 0.4 (3.7) 5.6 Share-based compensation expense (benefit), net of taxes $ 19.0 $ (1.5) $ 22.1 $ (26.3) Cash paid to settle STAP awards exercised during the six-month periods ended June 30, 2024 and June 30, 2023 was $31.9 million and $8.4 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. |
Stockholders_ Equity
Stockholders’ Equity | 6 Months Ended |
Jun. 30, 2024 | |
Stockholders' Equity Note [Abstract] | |
Stockholders’ Equity | 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 Six Months Ended 2024 2023 2024 2023 Numerator: Net income $ 278.1 $ 259.2 $ 584.7 $ 500.1 Denominator: Weighted average outstanding shares — basic 44.4 46.9 45.7 46.6 Effect of dilutive securities (1) : Stock options, RSUs, and ESPP (2) 3.1 2.6 2.9 3.0 Weighted average shares — diluted (2) 47.5 49.5 48.6 49.6 Net income per common share: Basic $ 6.26 $ 5.53 $ 12.79 $ 10.73 Diluted $ 5.85 $ 5.24 $ 12.03 $ 10.08 Stock options and RSUs excluded from calculation (2) 1.0 0.2 0.8 0.1 (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, representing 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 purchase under the ASR agreement was divided into two 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. At the final settlement of the $700 million second tranche, which we expect to occur in the third quarter of 2024, we may be entitled to receive additional shares of common stock, or, under certain limited circumstances, be required to make a cash payment to Citi or, if we so elect, deliver shares of common stock to Citi. The final number of shares that we will ultimately repurchase pursuant to the ASR agreement will be 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 under each tranche was accounted for as a reduction to stockholders’ equity in our consolidated balance sheets. The initial repurchase of our common stock and final settlement of the first tranche were 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 final settlement of the transactions under the ASR agreement is accounted for as an unsettled forward contract indexed to our common stock until the final settlement occurs. The forward contract related to the first tranche was equity classified, in accordance with ASC 815, Derivatives and Hedging , through final settlement. We expect equity classification for the second tranche to remain appropriate through final settlement during the third quarter of 2024. During the six months ended June 30, 2024, we recorded a liability of $6.4 million for an excise tax imposed under the Inflation Reduction Act as a result of our repurchase of shares under the ASR agreement. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2024 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Our effective income tax rate ( ETR ) for the six months ended June 30, 2024 and 2023 was 22 percent and 20 percent, respectively. Our ETR for the six months ended June 30, 2024 increased compared to our ETR for the six months ended June 30, 2023 primarily due to an increase in state taxes and a decrease in excess tax benefits from share-based compensation, partially offset by a lower amount of uncertain tax positions recorded. We record interest and penalties related to uncertain tax positions as a component of income tax expense. As of June 30, 2024 and December 31, 2023, our unrecognized tax benefits, including related interest, were approximately $20.4 million and $25.7 million, respectively. We believe that it is reasonably possible that the total amount of uncertain tax positions as of June 30, 2024 could decrease by up to approximately $15.0 million in the next 12 months as a result of audit closures, settlements, or the expiration of the statute of limitations. The ultimate finalization of our audits with relevant tax authorities can include formal administrative and legal proceedings, which could have a significant impact on the timing of changes to our uncertain positions. |
Segment Information
Segment Information | 6 Months Ended |
Jun. 30, 2024 | |
Segment Reporting [Abstract] | |
Segment Information | Segment Information We operate as one operating segment with a focus on the development and commercialization of products to address the unmet needs of patients with chronic and life-threatening conditions. Our Chief Executive Officer, as our chief operating decision maker, manages and allocates resources to the operations of our company on a consolidated basis. This enables our Chief Executive Officer to assess our overall level of available resources and determine how best to deploy these resources across functions, therapeutic areas, and research and development projects in line with our long-term company-wide strategic goals. Total revenues, cost of sales, and gross profit (loss) for each of our commercial products and other were as follows (in millions): Three Months Ended June 30, 2024 Tyvaso DPI (1) Nebulized Tyvaso (1) Remodulin (2) Orenitram Unituxin Adcirca Other Total Total revenues $ 258.3 $ 139.9 $ 147.3 $ 107.1 $ 51.7 $ 5.7 $ 4.9 $ 714.9 Cost of sales 37.6 8.4 12.8 5.9 3.8 2.6 6.7 77.8 Gross profit (loss) $ 220.7 $ 131.5 $ 134.5 $ 101.2 $ 47.9 $ 3.1 $ (1.8) $ 637.1 2023 Total revenues $ 193.6 $ 125.3 $ 127.2 $ 95.1 $ 44.3 $ 7.5 $ 3.5 $ 596.5 Cost of sales 33.0 7.4 7.3 5.7 2.7 3.1 4.9 64.1 Gross profit (loss) $ 160.6 $ 117.9 $ 119.9 $ 89.4 $ 41.6 $ 4.4 $ (1.4) $ 532.4 Six Months Ended June 30, 2024 Tyvaso DPI (1) Nebulized Tyvaso (1) Remodulin (2) Orenitram Unituxin Adcirca Other Total Total revenues $ 485.8 $ 284.9 $ 275.3 $ 213.3 $ 110.1 $ 12.1 $ 11.1 $ 1,392.6 Cost of sales 70.9 17.3 20.7 15.1 7.4 5.2 14.1 150.7 Gross profit (loss) $ 414.9 $ 267.6 $ 254.6 $ 198.2 $ 102.7 $ 6.9 $ (3.0) $ 1,241.9 2023 Total revenues $ 312.3 $ 245.0 $ 248.6 $ 183.3 $ 93.4 $ 14.8 $ 6.0 $ 1,103.4 Cost of sales 53.7 13.6 14.2 13.3 7.4 6.2 8.0 116.4 Gross profit (loss) $ 258.6 $ 231.4 $ 234.4 $ 170.0 $ 86.0 $ 8.6 $ (2.0) $ 987.0 (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 in which our customers (distributors) are located. 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 June 30, 2024 2023 U.S. ROW Total U.S. ROW Total Net product sales: Tyvaso DPI (1) $ 258.3 $ — $ 258.3 $ 193.6 $ — $ 193.6 Nebulized Tyvaso (1) 130.2 9.7 139.9 119.6 5.7 125.3 Total Tyvaso 388.5 9.7 398.2 313.2 5.7 318.9 Remodulin (2) 122.5 24.8 147.3 103.5 23.7 127.2 Orenitram 107.1 — 107.1 95.1 — 95.1 Unituxin 46.8 4.9 51.7 39.5 4.8 44.3 Adcirca 5.7 — 5.7 7.5 — 7.5 Other 4.6 0.3 4.9 3.2 0.3 3.5 Total revenues $ 675.2 $ 39.7 $ 714.9 $ 562.0 $ 34.5 $ 596.5 Six Months Ended June 30, 2024 2023 U.S. ROW Total U.S. ROW Total Net product sales: Tyvaso DPI (1) $ 485.8 $ — $ 485.8 $ 312.3 $ — $ 312.3 Nebulized Tyvaso (1) 263.9 21.0 284.9 235.3 9.7 245.0 Total Tyvaso 749.7 21.0 770.7 547.6 9.7 557.3 Remodulin (2) 230.8 44.5 275.3 196.7 51.9 248.6 Orenitram 213.3 — 213.3 183.3 — 183.3 Unituxin 100.2 9.9 110.1 83.8 9.6 93.4 Adcirca 12.1 — 12.1 14.8 — 14.8 Other 10.6 0.5 11.1 5.5 0.5 6.0 Total revenues $ 1,316.7 $ 75.9 $ 1,392.6 $ 1,031.7 $ 71.7 $ 1,103.4 (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: Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Distributor 1 51 % 52 % 51 % 51 % Distributor 2 36 % 34 % 35 % 33 % |
Litigation
Litigation | 6 Months Ended |
Jun. 30, 2024 | |
Litigation | |
Litigation | 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 to produce CADD-MS ® 3 ( MS-3 ) cartridges specifically for the administration of subcutaneous Remodulin for our patients, without making these cartridges available for the administration 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, 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 contract claim went to trial on April 29, 2024, and the court heard closing arguments on June 4, 2024. The court’s decision is pending. The trial was limited to determining the amount of damages under the breach of contract claim. RareGen has no claim for breach of contract and, as a result, has no remaining claims in the litigation. The parties will have the right to appeal the summary judgment decisions and the result of the trial upon entry of final judgment following the trial decision. We intend to continue to vigorously defend ourselves against the claims made in this litigation. Among other things, we 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 their own failure to properly plan their own product launch. However, due to the uncertainty inherent in any litigation, we cannot guarantee that an outcome adverse to us will not result. Any litigation of this nature could involve substantial cost, and an adverse outcome could result in substantial monetary damages. We currently are not able to reasonably estimate a range of potential losses due to the number of variables that may affect the outcome of the damages trial and any potential appeals, including potential damages amounts sought, the strength of our defenses, the variety of potential legal and factual determinations yet to be made by the court, the rulings that may be subject to appeal, and the inherent unpredictability of any outcome associated with these issues. Litigation with Liquidia Technologies, Inc. In March 2020, Liquidia Technologies, Inc. ( Liquidia ) filed two petitions for inter partes review ( IPR ) with the Patent Trial and Appeal Board ( PTAB ) of the U.S. Patent and Trademark Office ( USPTO ). In its petitions, Liquidia sought to invalidate U.S. Patent Nos. 9,604,901 (the ’901 patent ) and 9,593,066 (the ’066 patent ), both of which relate to a method of making treprostinil, the active pharmaceutical ingredient in Tyvaso DPI, nebulized Tyvaso, Remodulin, and Orenitram. These patents were issued in March 2017 and are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations publication, also known as the Orange Book , for Tyvaso DPI, nebulized Tyvaso, Remodulin, and Orenitram. In October 2020, the PTAB declined to institute IPR proceedings on the ’066 patent because Liquidia failed to establish a reasonable likelihood of prevailing on any claim relating to the ’066 patent. The PTAB instituted IPR proceedings on the ’901 patent in October 2020 and issued a final written decision in October 2021. The final written decision found that Liquidia had proven the invalidity of seven of the claims of the ‘901 patent but failed to prove the invalidity of two other claims. Each party appealed portions of this decision. The Federal Circuit affirmed the PTAB final written decision on June 27, 2024. We are evaluating whether to further pursue our appeal. No cancellation of patent claims takes effect until any IPR appeals are exhausted. In January 2020, Liquidia submitted an NDA to the FDA for approval of Yutrepia™, a dry powder inhalation formulation of treprostinil, to treat pulmonary arterial hypertension ( PAH ). This NDA was submitted under the 505(b)(2) regulatory pathway with nebulized Tyvaso as the reference listed drug. In November 2021, the FDA granted tentative approval of Liquidia’s NDA. In April 2020, we received a Paragraph IV Certification Notice Letter ( Notice Letter ) from Liquidia, stating that it intends to market Yutrepia before the expiration of all patents listed in the Orange Book for nebulized Tyvaso. The Notice Letter stated that Liquidia’s NDA for Yutrepia contains a Paragraph IV certification alleging that these patents are not valid, not enforceable, and/or will not be infringed by the commercial manufacture, use, or sale of Yutrepia. In June 2020, we filed a lawsuit in the U.S. District Court for the District of Delaware against Liquidia for infringement of the ’901 patent and the ’066 patent, both of which expire in December 2028. We filed our lawsuit within 45 days of receipt of notice from Liquidia of its NDA filing. As a result, under the Hatch-Waxman Act, the FDA was precluded by regulation from approving Liquidia’s NDA for up to 30 months or until the resolution of the litigation, whichever occurs first. In July 2020, Liquidia filed an answer to our complaint that included counterclaims alleging, among other things, that the patents at issue in the litigation are not valid and will not be infringed by the commercial manufacture, use, or sale of Yutrepia. In July 2020, the USPTO issued a new patent to us related to Tyvaso. The new patent, U.S. Patent No. 10,716,793 (the ’793 patent ), expires in May 2027, and is listed in the Orange Book for Tyvaso DPI and nebulized Tyvaso. In July 2020, we filed an amended complaint against Liquidia to include a claim for infringement of the ’793 patent. The ’793 patent relates to a method of administering treprostinil via inhalation and includes claims covering the dosing regimen used to administer Tyvaso DPI and nebulized Tyvaso. In December 2021, we filed a stipulation that the ’901 patent would not be infringed by Liquidia based on the court’s claim construction ruling. Trial took place during March 2022, and the court issued its decision in August 2022. The court found that Liquidia’s product would infringe the ’793 patent and that Liquidia had not proved that any claim of that patent is invalid. The court also determined that Liquidia had proved certain claims of the ’066 patent were invalid and that we had not proved Liquidia’s infringement of another ’066 patent claim. Accordingly, the court issued a final judgment that bars the FDA from approving Yutrepia until expiration of the ’793 patent in May 2027. The parties appealed portions of the decision adverse to each of them, and on July 24, 2023, the appellate court issued its decision affirming the district court decision in its entirety. The court subsequently denied the parties’ requests for rehearing, so the appellate court decision is now final. On January 23, 2024, Liquidia filed a petition for writ of certiorari seeking review by the U.S. Supreme Court, and that petition was denied on February 20, 2024. Liquidia also filed a motion with the district court seeking to modify the portion of the judgment that bars the FDA from finally approving Yutrepia until the ’793 patent expires. On March 28, 2024, the court granted the motion to permit the FDA to grant final approval for Yutrepia. We appealed that decision, and our appeal is pending with oral argument scheduled for September 3, 2024. In January 2021, Liquidia filed another petition for IPR with the PTAB. In its petition, Liquidia sought to invalidate the ’793 patent. In July 2022, the PTAB issued a final written decision finding all claims of the ’793 patent to be unpatentable. We filed a request for rehearing and for precedential opinion panel review. On October 26, 2022, the PTAB denied our request for precedential opinion panel review, but “determine[d] that the Board’s Final Written Decision did not address adequately whether the [references relied upon as the basis for canceling claims] qualify as prior art.” Thus, the PTAB directed the original panel “in its consideration on rehearing, to clearly identify whether the … references qualify as prior art.” The original panel issued its decision on our request for rehearing in February 2023. The original panel agreed that it had overlooked our arguments and that its rationale for determining that certain references are prior art was erroneous. Nonetheless, the original panel determined the references qualify as prior art under a new rationale. Thus, the original panel maintained that the claims of this patent are not valid. We appealed this decision, and the appellate court affirmed the PTAB decision. On January 19, 2024, we filed a petition for rehearing, and the court denied that motion on March 15, 2024. On June 10, 2024, we filed a petition seeking review by the U.S. Supreme Court. All claims of this patent remain valid until any IPR appeals are exhausted. On September 5, 2023, we filed a lawsuit in the U.S. District Court for the District of Delaware against Liquidia for infringement of the ’793 patent based on Liquidia’s efforts to obtain FDA approval for a PH-ILD indication for Yutrepia. On November 30, 2023, we filed an amended complaint to assert a new patent: U.S. Patent No. 11,826,327 (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. On January 22, 2024, we filed a stipulation withdrawing the ’793 patent from the case. As a result, the only patent at issue in the case is the ’327 patent. Liquidia answered the complaint asserting a variety of defenses. The case is pending, and the court has not yet set a schedule for the case. As noted below under FDA Litigation Regarding Yutrepia , we believe this lawsuit could entitle us to a 30-month stay, preventing the FDA from approving Yutrepia for the treatment of PH-ILD until the resolution of this lawsuit, or the expiration of the 30-month period following receipt of a Paragraph IV notice, whichever occurs first. Because the issue of whether a 30-month stay is appropriate remains unresolved, we filed a motion for preliminary injunction in the patent case on February 26, 2024. The court denied the motion on May 31, 2024. On May 10, 2024, we filed a citizen petition with the FDA asking the FDA to rescind its tentative approval of Yutrepia and issue a complete response letter to address an issue with Liquidia’s treprostinil supplier. That supplier is currently under a consent decree to address purported long-standing violations of the Food, Drug, and Cosmetics Act. The citizen petition seeks to ensure that Yutrepia is not approved until the supplier has fully and successfully discharged its obligations under the consent decree and that Liquidia supplies the FDA with sufficient data and information to establish that the identity, strength, quality, and purity of its proposed Yutrepia drug product in fact meets all the statutory and regulatory requirements for approval. The FDA’s response to our citizen petition is pending. In June 2021, we filed a motion in the patent case 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 employee, 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 Robert Roscigno in North Carolina state court. Discovery is complete. On July 3, 2024, Liquidia filed a motion for summary judgment, which is pending. We plan to continue to vigorously enforce our intellectual property rights related to Tyvaso DPI and nebulized Tyvaso. 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 submitted an amendment to its pending Yutrepia NDA to pursue approval for a PH-ILD indication. The suit alleges 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 wishes 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. The FDA represented at the hearing that it continues to assess the situation, so in the court’s view, there is no final agency action to review. The court requires the FDA to provide notice three business days before it acts on Liquidia’s amendment, so the parties can seek meaningful review when a decision is imminent. The FDA and Liquidia have filed motions to dismiss, and the parties are currently briefing those motions. No hearing date has been set. If Liquidia is required to submit a new NDA, we believe that we would be entitled to a 30-month stay of any PH-ILD approval based on our assertion of the ’327 patent against Liquidia as discussed under Litigation with Liquidia Technologies, Inc. That is, Liquidia could not obtain final approval for a PH-ILD indication until the earlier of the expiration of the 30-month stay or a district court decision in Liquidia’s favor. 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 towards 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. To date, neither Humana nor United has appealed these decisions. 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 Humana and United’s 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. We intend to continue to vigorously defend ourselves against the claims made in these lawsuits. 340B Program Litigation We participate in the Public Health Service’s 340B drug pricing program (the 340B program ), through which we sell our products to covered entities at no more than a statutory ceiling price. Increasing use of pharmacies that have contracts with such covered entities ( 340B contract pharmacies ), coupled with a lack of oversight and transparency, has resulted in increased risks of 340B statutory violations related to the diversion of 340B-purchased drugs to individuals who are not patients of the 340B covered entity, and to prohibited “duplicate discounts” when a Medicaid rebate is triggered on 340B-purchased drugs. In November 2020, we notified the U.S. Health Resources and Services Administration ( HRSA ) that we would begin implementing narrowly-tailored 340B contract pharmacy policies with the goal of stemming abuses of the 340B program without upsetting the status quo or creating hardship for covered entities or their patients. At around the same time, a number of other manufacturers also announced their own contract pharmacy policies. In December 2020, the U.S. Department of Health and Human Services ( HHS ) General Counsel issued a non-binding Advisory Opinion (the Advisory Opinion ) concluding that, among other things, pharmaceutical manufacturers are obligated to sell their drugs at the 340B discounted price to an unlimited number of 340B contract pharmacies. In May 2021, HRSA sent a letter to us stating that our 340B contract pharmacy policies violated the 340B statute. HRSA also sent materially similar letters to other pharmaceutical manufacturers. We responded to that letter by clarifying our policies and requesting additional information from HRSA. To date, HRSA has not responded. The federal government’s pronouncements regarding the use of 340B contract pharmacies have triggered a variety of litigation. In one of those cases, the court concluded that the Advisory Opinion was “legally flawed,” and in response HHS withdrew the Advisory Opinion. Notwithstanding the withdrawal of the Advisory Opinion, HRSA has made clear that it is not withdrawing its May 2021 letter to us and the threat of enforcement action. In June 2021, we commenced litigation against HRSA and HHS in the U.S. District Court for the District of Columbia seeking to vindicate the lawfulness of our 340B program contract pharmacy policies. Despite the litigation, in September 2021, HRSA sent to us, along with the other manufacturers challenging HRSA’s 340B interpretation, letters stating that HRSA was referring “this issue to the HHS Office of the Inspector General ( OIG )” for potential enforcement action. We have not received any communication from the OIG regarding our 340B contract pharmacy policy. Meanwhile, the parties submitted and fully briefed cross-motions for summary judgment, and the court heard oral argument on those motions, and also similar motions in a related case involving Novartis, in October 2021. In November 2021, the court granted our motion for summary judgment in part, and issued a decision holding that the HRSA letters threatening enforcement action “contain legal reasoning that rests upon an erroneous reading of Section 340B.” The court explained that “[t]he statute’s plain language, purpose, and structure do not prohibit drug manufacturers from attaching any conditions to the sales of covered drugs through contract pharmacies. Nor do they permit all conditions. Accordingly, any future enforcement action must rest on a new statutory provision, a new legislative rule, or a well-developed legal theory that Section 340B precludes the specific conditions at issue here.” HRSA and HSS appealed to the U.S. Court of Appeals for the District of Columbia Circuit in December 2021 and oral arguments were heard in October 2022. The court issued a decision affirming the district court on May 21, 2024, stating that “we hold that section 340B does not categorically prohibit manufacturers from imposing conditions on the distribution of covered drugs to covered entities. We further hold that the conditions at issue here do not violate section 340B on their face.” The government has not indicated whether it intends to further pursue the case. Litigation involving other manufacturers is also moving forward in parallel with our case, and some of the decisions issued in those cases have reached different conclusions regarding HRSA’s and HHS’s interpretation of the 340B statute than our case. We intend to continue to vigorously defend our 340B program contract pharmacy policies. |
Business Combination
Business Combination | 6 Months Ended |
Jun. 30, 2024 | |
Business Combination, Asset Acquisition, and Joint Venture Formation [Abstract] | |
Business Combination | Business Combination On October 29, 2023, we entered into an Agreement and Plan of Merger (the Merger Agreement ) with Miromatrix, a publicly traded company developing bioengineered kidney and liver products. On December 13, 2023, we completed the transactions contemplated by the Merger Agreement and Miromatrix became a wholly-owned subsidiary of United Therapeutics. Pursuant to the terms of the Merger Agreement, we paid former Miromatrix shareholders $3.25 per share in cash at closing, representing cash consideration paid to former Miromatrix shareholders of $89.1 million. Former Miromatrix shareholders also received one contractual contingent value right per share, representing the right to receive a contingent payment of $1.75 per share in cash (an aggregate of approximately $54.0 million) upon the first implantation of Miromatrix’s development-stage, fully-implantable kidney product known as mirokidney into a living human patient by the end of 2025 in a clinical trial meeting requirements set forth in the form of the Contingent Value Rights Agreement attached to the Merger Agreement. In addition to the cash consideration noted above, the aggregate purchase price included $2.5 million that we ascribed to the contingent value rights, of which $1.4 million was recorded as a measurement period adjustment during the six months ended June 30, 2024. The merger met the definition of a business combination in accordance with ASC 805, Business Combinations , and as such, we applied the acquisition method to account for the transaction, which requires, among other things, that assets acquired and liabilities assumed be recognized at their fair values as of the closing date. The allocation of the purchase price to the assets acquired and liabilities assumed, including the residual amount allocated to goodwill, is based upon preliminary information and is subject to change within the measurement period (up to one year from the closing date) as additional information concerning final asset and liability valuations is obtained. The primary element of this preliminary purchase price allocation that is not yet finalized relates to our assessment of tax attributes. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||
Net income | $ 278.1 | $ 259.2 | $ 584.7 | $ 500.1 |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended | 6 Months Ended |
Jun. 30, 2024 shares | Jun. 30, 2024 shares | |
Trading Arrangements, by Individual | ||
Non-Rule 10b5-1 Arrangement Adopted | false | |
Rule 10b5-1 Arrangement Terminated | false | |
Non-Rule 10b5-1 Arrangement Terminated | false | |
James Edgemond [Member] | ||
Trading Arrangements, by Individual | ||
Material Terms of Trading Arrangement | On May 17, 2024, James Edgemond, a Section 16 officer, adopted a trading plan intended to satisfy Rule 10b5-1(c) to exercise up to 100,000 stock options, and to sell up to 80,000 shares of common stock received upon exercise of such stock options, subject to certain conditions. | |
Name | James Edgemond | |
Title | Section 16 officer | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | May 17, 2024 | |
Paul Mahon [Member] | ||
Trading Arrangements, by Individual | ||
Material Terms of Trading Arrangement | On June 20, 2024, Paul Mahon, a Section 16 officer, adopted a trading plan intended to satisfy Rule 10b5-1(c) to exercise up to 91,250 STAP awards, subject to certain conditions. | |
Name | Paul Mahon | |
Title | Section 16 officer | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | June 20, 2024 | |
Aggregate Available | 91,250 | 91,250 |
Exercise Of Stock Options [Member] | James Edgemond [Member] | ||
Trading Arrangements, by Individual | ||
Aggregate Available | 100,000 | 100,000 |
Sale Of Shares Of Common Stock [Member] | James Edgemond [Member] | ||
Trading Arrangements, by Individual | ||
Aggregate Available | 80,000 | 80,000 |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Recently Issued Accounting Standards | Recently Issued Accounting Standards Accounting Standards Adopted During the Period None. Accounting Standards Not Yet Adopted In October 2023, the FASB issued Accounting Standards Update ( ASU ) 2023-06, Disclosure Improvements, which incorporates certain existing or incremental disclosure and presentation requirements of SEC Regulation S-X and Regulation S-K into the FASB Accounting Standards Codification ( Codification ). The amendments in the ASU are expected to clarify or improve disclosure and presentation requirements of a variety of Codification topics and to align the requirements in the Codification with the SEC’s regulations. The effective date for each amendment in the ASU will be the date on which the SEC’s removal of the related disclosure requirement from Regulation S-X or Regulation S-K becomes effective, or if the SEC has not removed the related requirement by June 30, 2027, the applicable amendment will be removed from the Codification and will not become effective for any entity. Early adoption is prohibited. We are evaluating the impact of adopting this guidance on our consolidated financial statements. In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which is intended to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant expenses. This ASU requires disclosures to include significant segment expenses that are regularly provided to the chief operating decision maker ( CODM ), a description of other segment items by reportable segment, and any additional measures of a segment profit or loss used by the CODM when deciding how to allocate resources. This ASU also requires all annual disclosures currently required by Topic 280 to be included in interim period disclosures. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, although early adoption is permitted. The guidance requires retrospective application to all prior periods presented in the financial statements. We are evaluating the impact of adopting this guidance on our consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which enhances the required disclosures primarily related to the 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 annual periods beginning after December 15, 2024, although early adoption is permitted. We are evaluating the impact of adopting this guidance on our consolidated financial statements. |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Investments [Abstract] | |
Schedule of 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 of accumulated other comprehensive loss in stockholders’ equity, until realized. Available-for-sale debt securities consisted of the following (in millions): As of June 30, 2024 Amortized Gross Gross Fair U.S. government and agency securities $ 2,386.7 $ 0.4 $ (14.3) $ 2,372.8 Corporate debt securities 582.7 0.4 (3.4) 579.7 Total (1) $ 2,969.4 $ 0.8 $ (17.7) $ 2,952.5 Reported under the following captions in our consolidated balance sheets: Cash and cash equivalents $ 27.2 Current marketable investments 1,594.9 Non-current marketable investments 1,330.4 Total (1) $ 2,952.5 As of December 31, 2023 Amortized Gross Gross Fair U.S. government and agency securities $ 3,044.5 $ 5.3 $ (17.2) $ 3,032.6 Corporate debt securities 727.2 2.1 (4.7) 724.6 Total (2) $ 3,771.7 $ 7.4 $ (21.9) $ 3,757.2 Reported under the following captions in our consolidated balance sheets: Cash and cash equivalents $ 75.9 Current marketable investments 1,771.5 Non-current marketable investments 1,909.8 Total (2) $ 3,757.2 (1) Total excludes $45.0 million related to available-for-sale debt securities that matured on June 30, 2024, although cash proceeds were not received until July 1, 2024. We recorded the $45.0 million receivable within other current assets in our consolidated balance sheets as of June 30, 2024. (2) Total excludes $21.0 million related to available-for-sale debt securities that matured on December 31, 2023, although cash proceeds were not received until January 2, 2024. We recorded the $21.0 million receivable within other current assets in our consolidated balance sheets as of December 31, 2023. |
Schedule of Available-for-Sale Debt Securities in an Unrealized Loss Position | 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, 2024 and December 31, 2023, 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 June 30, 2024 Fair Value Gross Fair Value Gross Fair Value Gross U.S. government and agency securities $ 1,145.8 $ (4.9) $ 1,114.6 $ (9.4) $ 2,260.4 $ (14.3) Corporate debt securities 289.0 (1.4) 154.6 (2.0) 443.6 (3.4) Total $ 1,434.8 $ (6.3) $ 1,269.2 $ (11.4) $ 2,704.0 $ (17.7) Less than 12 months 12 months or longer Total As of December 31, 2023 Fair Value Gross Fair Value Gross Fair Value Gross U.S. government and agency securities $ 1,101.8 $ (4.4) $ 838.1 $ (12.8) $ 1,939.9 $ (17.2) Corporate debt securities 209.4 (0.5) 284.1 (4.2) 493.5 (4.7) Total $ 1,311.2 $ (4.9) $ 1,122.2 $ (17.0) $ 2,433.4 $ (21.9) |
Schedule of the Contractual Maturities | 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 June 30, 2024 Amortized Cost Fair Value Due within one year $ 1,632.2 $ 1,622.1 Due in one to three years 1,337.2 1,330.4 Total $ 2,969.4 $ 2,952.5 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets and Liabilities Subject to Fair Value Measurements | Assets and liabilities subject to fair value measurements are as follows (in millions): As of June 30, 2024 Level 1 Level 2 Level 3 Balance Assets Money market funds (1) $ 104.2 $ — $ — $ 104.2 Time deposits (1) 343.9 — — 343.9 U.S. government and agency securities (2) — 2,372.8 — 2,372.8 Corporate debt securities (2) — 579.7 — 579.7 Equity securities (3) 20.9 — — 20.9 Total assets $ 469.0 $ 2,952.5 $ — $ 3,421.5 Liabilities Contingent consideration (4) — — 22.6 22.6 Total liabilities $ — $ — $ 22.6 $ 22.6 As of December 31, 2023 Level 1 Level 2 Level 3 Balance Assets Money market funds (1) $ 408.5 $ — $ — $ 408.5 Time deposits (1) 126.4 — — 126.4 U.S. government and agency securities (2) — 3,032.6 — 3,032.6 Corporate debt securities (2) — 724.6 — 724.6 Equity securities (3) 14.9 — — 14.9 Total assets $ 549.8 $ 3,757.2 $ — $ 4,307.0 Liabilities Contingent consideration (4) — — 21.1 21.1 Total liabilities $ — $ — $ 21.1 $ 21.1 (1) Included in cash and cash equivalents in our consolidated balance sheets. (2) Included in cash and cash equivalents and current and non-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 in current 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 six months ended June 30, 2024 we recognized $0.4 million and $6.0 million of net unrealized gains, respectively, on these securities. During the three and six months ended June 30, 2023, we recognized $1.6 million and $10.4 million of net unrealized losses, respectively, on these securities. We recorded these gains and losses in our consolidated statements of operations within other income (expense), net . See Note 3— Investments—Marketable Investments—Investments in Equity Securities with Readily Determinable Fair Values . (4) Included in other current liabilities and other non-current liabilities in our consolidated balance sheets. The fair value of our contingent consideration obligations has been 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 $1.5 million during the six months ended June 30, 2024, of which $1.4 million was a measurement period adjustment related to our acquisition of Miromatrix Medical Inc. ( Miromatrix ) in 2023, with the remaining change recorded within research and development in our consolidated statements of operations. |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories, Net of Reserves | 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): June 30, 2024 December 31, 2023 Raw materials $ 22.0 $ 21.7 Work-in-progress 34.4 34.4 Finished goods 80.1 55.7 Total inventories $ 136.5 $ 111.8 |
Property, Plant, and Equipment
Property, Plant, and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | Property, plant, and equipment consists of the following (in millions): June 30, 2024 December 31, 2023 Land and land improvements $ 152.9 $ 148.0 Buildings, building improvements, and leasehold improvements 851.5 685.3 Buildings under construction 110.1 259.1 Furniture, equipment, and vehicles 441.4 381.2 Subtotal 1,555.9 1,473.6 Less—accumulated depreciation (461.3) (428.2) Property, plant, and equipment, net $ 1,094.6 $ 1,045.4 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Components of Share-Based Compensation Expense Recognized | The following table reflects the components of share-based compensation expense recognized in our consolidated statements of operations (in millions): Three Months Ended Six Months Ended 2024 2023 2024 2023 Stock options $ 8.1 $ 1.6 $ 13.8 $ 6.5 RSUs 19.2 13.6 34.7 25.8 STAP awards 21.9 (1.9) 25.8 (31.9) ESPP 0.5 0.5 1.0 1.0 Total share-based compensation expense before tax $ 49.7 $ 13.8 $ 75.3 $ 1.4 |
Schedule of Weighted-Average Assumptions to Measure the Fair Value of Stock Options | 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, 2024 and 2023: June 30, 2024 June 30, 2023 Expected term of awards (in years) 6.5 6.5 Expected volatility 31.6 % 31.4 % Risk-free interest rate 4.3 % 3.6 % Expected dividend yield — % — % |
Schedule of Activity and Status of Stock Options | A summary of the activity and status of stock options under our equity incentive plans during the six-month period ended June 30, 2024 is presented below: Number of Weighted Weighted Aggregate Outstanding as of January 1, 2024 6,213,853 $ 136.60 Granted 535,797 236.02 Exercised (725,416) 129.89 Forfeited — — Outstanding as of June 30, 2024 6,024,234 $ 146.25 3.9 $ 1,038.0 Exercisable as of June 30, 2024 5,029,432 $ 130.15 2.8 $ 947.6 Unvested as of June 30, 2024 994,802 $ 227.64 9.3 $ 90.4 |
Schedule of Share-Based Compensation Expense (Benefit) Recognized | Total share-based compensation expense related to stock options is recorded as follows (in millions): Three Months Ended Six Months Ended 2024 2023 2024 2023 Cost of sales $ — $ — $ — $ — Research and development 0.1 — 0.2 0.1 Selling, general, and administrative 8.0 1.6 13.6 6.4 Share-based compensation expense before taxes 8.1 1.6 13.8 6.5 Related income tax benefit (0.3) (0.1) (0.5) (0.3) Share-based compensation expense, net of taxes $ 7.8 $ 1.5 $ 13.3 $ 6.2 Total share-based compensation expense related to RSUs is recorded as follows (in millions): Three Months Ended Six Months Ended 2024 2023 2024 2023 Cost of sales $ 1.1 $ 1.0 $ 2.0 $ 2.0 Research and development 5.8 5.1 11.4 9.8 Selling, general, and administrative 12.3 7.5 21.3 14.0 Share-based compensation expense before taxes 19.2 13.6 34.7 25.8 Related income tax benefit (3.5) (3.2) (6.8) (6.1) Share-based compensation expense, net of taxes $ 15.7 $ 10.4 $ 27.9 $ 19.7 Share-based compensation expense (benefit) recognized in connection with STAP awards is as follows (in millions): Three Months Ended Six Months Ended 2024 2023 2024 2023 Cost of sales $ 0.8 $ (0.1) $ 1.0 $ (1.5) Research and development 2.5 (0.4) 3.0 (4.1) Selling, general, and administrative 18.6 (1.4) 21.8 (26.3) Share-based compensation expense (benefit) before taxes 21.9 (1.9) 25.8 (31.9) Related income tax (benefit) expense (2.9) 0.4 (3.7) 5.6 Share-based compensation expense (benefit), net of taxes $ 19.0 $ (1.5) $ 22.1 $ (26.3) |
Summary of Stock Option Exercise Data | Stock option exercise data is summarized below (dollars in millions): Three Months Ended Six Months Ended 2024 2023 2024 2023 Number of options exercised 398,149 214,244 725,416 753,344 Cash received $ 52.1 $ 24.7 $ 94.3 $ 86.1 Total intrinsic value of options exercised $ 52.3 $ 23.8 $ 88.0 $ 95.4 |
Schedule of Restricted Stock Units Activity | A summary of the activity with respect to, and status of, RSUs during the six-month period ended June 30, 2024 is presented below: Number of Weighted Unvested as of January 1, 2024 964,759 $ 210.35 Granted 396,352 235.84 Vested (140,382) 186.67 Forfeited (11,958) 214.60 Unvested as of June 30, 2024 1,208,771 $ 221.41 |
Schedule of Weighted-Average Assumptions to Measure the Fair Value of Outstanding STAP Awards | The table below includes the weighted average assumptions used to measure the fair value of the outstanding STAP awards: June 30, 2024 June 30, 2023 Expected term of awards (in years) 0.7 0.8 Expected volatility 29.4 % 26.1 % Risk-free interest rate 5.2 % 5.4 % Expected dividend yield — % — % |
Schedule of the Activity and Status of STAP Awards | A summary of the activity and status of STAP awards during the six-month period ended June 30, 2024 is presented below: Number of Weighted Weighted Aggregate Outstanding as of January 1, 2024 443,058 $ 149.21 Granted — — Exercised (273,206) 143.31 Forfeited — — Outstanding as of June 30, 2024 169,852 $ 158.70 0.7 $ 27.2 Exercisable as of June 30, 2024 169,852 $ 158.70 0.7 $ 27.2 Unvested as of June 30, 2024 — $ — — $ — |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Components of Basic and Diluted Earnings (Loss) Per Common Share | The components of basic and diluted earnings per common share comprised the following (in millions, except per share amounts): Three Months Ended Six Months Ended 2024 2023 2024 2023 Numerator: Net income $ 278.1 $ 259.2 $ 584.7 $ 500.1 Denominator: Weighted average outstanding shares — basic 44.4 46.9 45.7 46.6 Effect of dilutive securities (1) : Stock options, RSUs, and ESPP (2) 3.1 2.6 2.9 3.0 Weighted average shares — diluted (2) 47.5 49.5 48.6 49.6 Net income per common share: Basic $ 6.26 $ 5.53 $ 12.79 $ 10.73 Diluted $ 5.85 $ 5.24 $ 12.03 $ 10.08 Stock options and RSUs excluded from calculation (2) 1.0 0.2 0.8 0.1 (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. |
Segment Information (Tables)
Segment Information (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Segment Reporting [Abstract] | |
Schedule of Net Product Sales, Cost of Product Sales and Gross Profit for Each Commercial Products | Total revenues, cost of sales, and gross profit (loss) for each of our commercial products and other were as follows (in millions): Three Months Ended June 30, 2024 Tyvaso DPI (1) Nebulized Tyvaso (1) Remodulin (2) Orenitram Unituxin Adcirca Other Total Total revenues $ 258.3 $ 139.9 $ 147.3 $ 107.1 $ 51.7 $ 5.7 $ 4.9 $ 714.9 Cost of sales 37.6 8.4 12.8 5.9 3.8 2.6 6.7 77.8 Gross profit (loss) $ 220.7 $ 131.5 $ 134.5 $ 101.2 $ 47.9 $ 3.1 $ (1.8) $ 637.1 2023 Total revenues $ 193.6 $ 125.3 $ 127.2 $ 95.1 $ 44.3 $ 7.5 $ 3.5 $ 596.5 Cost of sales 33.0 7.4 7.3 5.7 2.7 3.1 4.9 64.1 Gross profit (loss) $ 160.6 $ 117.9 $ 119.9 $ 89.4 $ 41.6 $ 4.4 $ (1.4) $ 532.4 Six Months Ended June 30, 2024 Tyvaso DPI (1) Nebulized Tyvaso (1) Remodulin (2) Orenitram Unituxin Adcirca Other Total Total revenues $ 485.8 $ 284.9 $ 275.3 $ 213.3 $ 110.1 $ 12.1 $ 11.1 $ 1,392.6 Cost of sales 70.9 17.3 20.7 15.1 7.4 5.2 14.1 150.7 Gross profit (loss) $ 414.9 $ 267.6 $ 254.6 $ 198.2 $ 102.7 $ 6.9 $ (3.0) $ 1,241.9 2023 Total revenues $ 312.3 $ 245.0 $ 248.6 $ 183.3 $ 93.4 $ 14.8 $ 6.0 $ 1,103.4 Cost of sales 53.7 13.6 14.2 13.3 7.4 6.2 8.0 116.4 Gross profit (loss) $ 258.6 $ 231.4 $ 234.4 $ 170.0 $ 86.0 $ 8.6 $ (2.0) $ 987.0 (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. |
Schedule of Net Revenues from External Customers by Geographic Area | Geographic revenues are determined based on the country in which our customers (distributors) are located. 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 June 30, 2024 2023 U.S. ROW Total U.S. ROW Total Net product sales: Tyvaso DPI (1) $ 258.3 $ — $ 258.3 $ 193.6 $ — $ 193.6 Nebulized Tyvaso (1) 130.2 9.7 139.9 119.6 5.7 125.3 Total Tyvaso 388.5 9.7 398.2 313.2 5.7 318.9 Remodulin (2) 122.5 24.8 147.3 103.5 23.7 127.2 Orenitram 107.1 — 107.1 95.1 — 95.1 Unituxin 46.8 4.9 51.7 39.5 4.8 44.3 Adcirca 5.7 — 5.7 7.5 — 7.5 Other 4.6 0.3 4.9 3.2 0.3 3.5 Total revenues $ 675.2 $ 39.7 $ 714.9 $ 562.0 $ 34.5 $ 596.5 Six Months Ended June 30, 2024 2023 U.S. ROW Total U.S. ROW Total Net product sales: Tyvaso DPI (1) $ 485.8 $ — $ 485.8 $ 312.3 $ — $ 312.3 Nebulized Tyvaso (1) 263.9 21.0 284.9 235.3 9.7 245.0 Total Tyvaso 749.7 21.0 770.7 547.6 9.7 557.3 Remodulin (2) 230.8 44.5 275.3 196.7 51.9 248.6 Orenitram 213.3 — 213.3 183.3 — 183.3 Unituxin 100.2 9.9 110.1 83.8 9.6 93.4 Adcirca 12.1 — 12.1 14.8 — 14.8 Other 10.6 0.5 11.1 5.5 0.5 6.0 Total revenues $ 1,316.7 $ 75.9 $ 1,392.6 $ 1,031.7 $ 71.7 $ 1,103.4 (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. |
Schedule of Revenue from Two Specialty Pharmaceutical Distributors in the United States as a Percentage of Total Revenue | 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 June 30, Six Months Ended June 30, 2024 2023 2024 2023 Distributor 1 51 % 52 % 51 % 51 % Distributor 2 36 % 34 % 35 % 33 % |
Investments - Available-for-Sal
Investments - Available-for-Sale Debt Securities (Details) - USD ($) $ in Millions | Jun. 30, 2024 | Dec. 31, 2023 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 2,969.4 | $ 3,771.7 |
Gross Unrealized Gains | 0.8 | 7.4 |
Gross Unrealized Losses | (17.7) | (21.9) |
Fair Value | 2,952.5 | 3,757.2 |
Available-for-sale debt securities receivable | 45 | 21 |
U.S. government and agency securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 2,386.7 | 3,044.5 |
Gross Unrealized Gains | 0.4 | 5.3 |
Gross Unrealized Losses | (14.3) | (17.2) |
Fair Value | 2,372.8 | 3,032.6 |
Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 582.7 | 727.2 |
Gross Unrealized Gains | 0.4 | 2.1 |
Gross Unrealized Losses | (3.4) | (4.7) |
Fair Value | $ 579.7 | $ 724.6 |
Investments - Current and Non-c
Investments - Current and Non-current of Available-for-Sale Debt Securities (Details) - USD ($) $ in Millions | Jun. 30, 2024 | Dec. 31, 2023 |
Reported under the following captions in our consolidated balance sheets: | ||
Total | $ 2,952.5 | $ 3,757.2 |
Cash and cash equivalents | ||
Reported under the following captions in our consolidated balance sheets: | ||
Current available-for-sale debt securities | 27.2 | 75.9 |
Current marketable investments | ||
Reported under the following captions in our consolidated balance sheets: | ||
Current available-for-sale debt securities | 1,594.9 | 1,771.5 |
Non-current marketable investments | ||
Reported under the following captions in our consolidated balance sheets: | ||
Non-current marketable investments | $ 1,330.4 | $ 1,909.8 |
Investments - Available-for-S_2
Investments - Available-for-Sale Debt Securities in Unrealized Loss Position (Details) - USD ($) $ in Millions | Jun. 30, 2024 | Dec. 31, 2023 |
Fair Value | ||
Less than 12 months | $ 1,434.8 | $ 1,311.2 |
12 months or longer | 1,269.2 | 1,122.2 |
Total | 2,704 | 2,433.4 |
Gross Unrealized Losses | ||
Less than 12 months | (6.3) | (4.9) |
12 months or longer | (11.4) | (17) |
Total | (17.7) | (21.9) |
U.S. government and agency securities | ||
Fair Value | ||
Less than 12 months | 1,145.8 | 1,101.8 |
12 months or longer | 1,114.6 | 838.1 |
Total | 2,260.4 | 1,939.9 |
Gross Unrealized Losses | ||
Less than 12 months | (4.9) | (4.4) |
12 months or longer | (9.4) | (12.8) |
Total | (14.3) | (17.2) |
Corporate debt securities | ||
Fair Value | ||
Less than 12 months | 289 | 209.4 |
12 months or longer | 154.6 | 284.1 |
Total | 443.6 | 493.5 |
Gross Unrealized Losses | ||
Less than 12 months | (1.4) | (0.5) |
12 months or longer | (2) | (4.2) |
Total | $ (3.4) | $ (4.7) |
Investments - Available-for-S_3
Investments - Available-for-Sale Debt Securities - Narrative (Details) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 USD ($) investment | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) investment | Jun. 30, 2023 USD ($) | Dec. 31, 2023 investment | |
Investments [Abstract] | |||||
Debt Securities, available-for-sale, unrealized loss position, number of positions | investment | 541 | 541 | 385 | ||
Impairments related to credit loss | $ | $ 0 | $ 0 | $ 0 | $ 0 |
Investments - Contractual Matur
Investments - Contractual Maturities of Available-for-Sale Marketable Investments (Details) $ in Millions | Jun. 30, 2024 USD ($) |
Amortized Cost | |
Due within one year | $ 1,632.2 |
Due in one to three years | 1,337.2 |
Total | 2,969.4 |
Fair Value | |
Due within one year | 1,622.1 |
Due in one to three years | 1,330.4 |
Total | $ 2,952.5 |
Investments - Investments in Eq
Investments - Investments in Equity Securities with Readily Determinable Fair Values (Details) - USD ($) $ in Millions | Jun. 30, 2024 | Dec. 31, 2023 |
Investments [Abstract] | ||
Investments in equity securities with readily determinable fair value | $ 20.9 | $ 14.9 |
Investments - Investments in Pr
Investments - Investments in Privately-Held Companies (Details) - USD ($) $ in Millions | Jun. 30, 2024 | Dec. 31, 2023 |
Privately-held Companies | ||
Investments in Privately-Held Companies and Investments in Equity Securities with Readily Determinable Fair Values | ||
Investments in privately-held companies | $ 29 | $ 28.5 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Liabilities | |||||
Increase in fair value of contingent consideration liability | $ 1.5 | ||||
Miromatrix | |||||
Liabilities | |||||
Increase in fair value of contingent consideration liability | 1.4 | ||||
Measurement period adjustment | 1.4 | ||||
Recurring fair value measurements | Other income (expense), net | |||||
Liabilities | |||||
Net unrealized gain (loss) on securities | $ 0.4 | $ (1.6) | 6 | $ (10.4) | |
Recurring fair value measurements | Level 1 | |||||
Assets | |||||
Total assets | 469 | 469 | $ 549.8 | ||
Liabilities | |||||
Contingent consideration | 0 | 0 | 0 | ||
Total liabilities | 0 | 0 | 0 | ||
Recurring fair value measurements | Level 1 | Money market funds | |||||
Assets | |||||
Total assets | 104.2 | 104.2 | 408.5 | ||
Recurring fair value measurements | Level 1 | Time deposits | |||||
Assets | |||||
Total assets | 343.9 | 343.9 | 126.4 | ||
Recurring fair value measurements | Level 1 | U.S. government and agency securities | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Recurring fair value measurements | Level 1 | Corporate debt securities | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Recurring fair value measurements | Level 1 | Equity securities | |||||
Assets | |||||
Total assets | 20.9 | 20.9 | 14.9 | ||
Recurring fair value measurements | Level 2 | |||||
Assets | |||||
Total assets | 2,952.5 | 2,952.5 | 3,757.2 | ||
Liabilities | |||||
Contingent consideration | 0 | 0 | 0 | ||
Total liabilities | 0 | 0 | 0 | ||
Recurring fair value measurements | Level 2 | Money market funds | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Recurring fair value measurements | Level 2 | Time deposits | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Recurring fair value measurements | Level 2 | U.S. government and agency securities | |||||
Assets | |||||
Total assets | 2,372.8 | 2,372.8 | 3,032.6 | ||
Recurring fair value measurements | Level 2 | Corporate debt securities | |||||
Assets | |||||
Total assets | 579.7 | 579.7 | 724.6 | ||
Recurring fair value measurements | Level 2 | Equity securities | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Recurring fair value measurements | Level 3 | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Liabilities | |||||
Contingent consideration | 22.6 | 22.6 | 21.1 | ||
Total liabilities | 22.6 | 22.6 | 21.1 | ||
Recurring fair value measurements | Level 3 | Money market funds | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Recurring fair value measurements | Level 3 | Time deposits | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Recurring fair value measurements | Level 3 | U.S. government and agency securities | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Recurring fair value measurements | Level 3 | Corporate debt securities | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Recurring fair value measurements | Level 3 | Equity securities | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Recurring fair value measurements | Balance | |||||
Assets | |||||
Total assets | 3,421.5 | 3,421.5 | 4,307 | ||
Liabilities | |||||
Contingent consideration | 22.6 | 22.6 | 21.1 | ||
Total liabilities | 22.6 | 22.6 | 21.1 | ||
Recurring fair value measurements | Balance | Money market funds | |||||
Assets | |||||
Total assets | 104.2 | 104.2 | 408.5 | ||
Recurring fair value measurements | Balance | Time deposits | |||||
Assets | |||||
Total assets | 343.9 | 343.9 | 126.4 | ||
Recurring fair value measurements | Balance | U.S. government and agency securities | |||||
Assets | |||||
Total assets | 2,372.8 | 2,372.8 | 3,032.6 | ||
Recurring fair value measurements | Balance | Corporate debt securities | |||||
Assets | |||||
Total assets | 579.7 | 579.7 | 724.6 | ||
Recurring fair value measurements | Balance | Equity securities | |||||
Assets | |||||
Total assets | $ 20.9 | $ 20.9 | $ 14.9 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Millions | Jun. 30, 2024 | Dec. 31, 2023 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 22 | $ 21.7 |
Work-in-progress | 34.4 | 34.4 |
Finished goods | 80.1 | 55.7 |
Total inventories | $ 136.5 | $ 111.8 |
Property, Plant, and Equipmen_2
Property, Plant, and Equipment (Details) - USD ($) $ in Millions | Jun. 30, 2024 | Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 1,555.9 | $ 1,473.6 |
Less—accumulated depreciation | (461.3) | (428.2) |
Property, plant, and equipment, net | 1,094.6 | 1,045.4 |
Land and land improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 152.9 | 148 |
Buildings, building improvements, and leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 851.5 | 685.3 |
Buildings under construction | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 110.1 | 259.1 |
Furniture, equipment, and vehicles | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 441.4 | $ 381.2 |
Debt (Details)
Debt (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2024 | Jun. 30, 2024 | Jun. 30, 2024 | Dec. 31, 2023 | |
Debt | |||||
Line of credit (current) | $ 400,000,000 | $ 400,000,000 | $ 400,000,000 | ||
First Unsecured Revolving Credit Facility | |||||
Debt | |||||
Borrowing capacity | $ 1,200,000,000 | ||||
Second Unsecured Revolving Credit Facility | |||||
Debt | |||||
Borrowing capacity | 800,000,000 | ||||
Increase in borrowing capacity | 500,000,000 | ||||
2022 Credit Agreement | |||||
Debt | |||||
Term of maturity date extension | 1 year | ||||
Proceeds from issuance of long-term debt | $ 800,000,000 | ||||
Outstanding balance | 500,000,000 | 500,000,000 | $ 700,000,000 | ||
Repayments of long term debt | 100,000,000 | 200,000,000 | |||
Line of credit (current) | $ 400,000,000 | $ 400,000,000 |
Share-Based Compensation - Gene
Share-Based Compensation - General (Details) | 1 Months Ended | 6 Months Ended | |
Jun. 30, 2024 plan shares | Feb. 28, 2019 shares | Jun. 30, 2024 plan shares | |
Share-Based Compensation | |||
Number of equity incentive plans | plan | 2 | 2 | |
2015 Plan | |||
Share-Based Compensation | |||
Maximum number of shares authorized to be issued (in shares) | 13,820,000 | 13,820,000 | |
Number of additional shares authorized (in shares) | 1,320,000 | ||
2019 Inducement Plan | Newly-Hired Employees | |||
Share-Based Compensation | |||
Number of equity incentive plans | plan | 1 | 1 | |
Granted (in shares) | 99,000 | ||
Amended and Restated Equity Incentive Plan (The 1999 Plan) | |||
Share-Based Compensation | |||
Granted (in shares) | 0 |
Share-Based Compensation - Allo
Share-Based Compensation - Allocation of Compensation Expense (Benefit) by Plan (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-Based Compensation | ||||
Total share-based compensation expense before tax | $ 49.7 | $ 13.8 | $ 75.3 | $ 1.4 |
Stock options | ||||
Share-Based Compensation | ||||
Total share-based compensation expense before tax | 8.1 | 1.6 | 13.8 | 6.5 |
RSUs | ||||
Share-Based Compensation | ||||
Total share-based compensation expense before tax | 19.2 | 13.6 | 34.7 | 25.8 |
STAP awards | ||||
Share-Based Compensation | ||||
Total share-based compensation expense before tax | 21.9 | (1.9) | 25.8 | (31.9) |
ESPP | ||||
Share-Based Compensation | ||||
Total share-based compensation expense before tax | $ 0.5 | $ 0.5 | $ 1 | $ 1 |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Options Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Awards granted | ||||
Share-based compensation expense (benefit) before taxes | $ 49.7 | $ 13.8 | $ 75.3 | $ 1.4 |
Unrecognized compensation cost | 68 | $ 68 | ||
Stock Options with Performance Conditions | ||||
Awards granted | ||||
Granted (in shares) | 500,000 | 400,000 | ||
Total grant date fair value | $ 50.2 | $ 35.6 | ||
Share-based compensation expense (benefit) before taxes | 7.1 | 1 | 11.9 | 1.2 |
Aggregate grant date fair value | $ 50.2 | 35.6 | ||
Stock options | ||||
Awards granted | ||||
Granted (in shares) | 535,797 | |||
Total grant date fair value | $ 52.1 | 36.3 | ||
Share-based compensation expense (benefit) before taxes | $ 8.1 | $ 1.6 | $ 13.8 | $ 6.5 |
Weighted average grant date fair value of stock options (in dollars per share) | $ 97.24 | $ 85.52 | ||
Aggregate grant date fair value | $ 52.1 | $ 36.3 | ||
Total grant date fair value of employee stock options that vested | $ 0.9 | $ 52.9 | ||
Weighted average remaining vesting period | 2 years 4 months 24 days | |||
Amended and Restated Equity Incentive Plan (The 1999 Plan) | ||||
Awards granted | ||||
Granted (in shares) | 0 |
Share-Based Compensation - Assu
Share-Based Compensation - Assumptions For Stock Options (Details) - Stock options | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Share-Based Compensation | ||
Expected term of awards (in years) | 6 years 6 months | 6 years 6 months |
Expected volatility | 31.60% | 31.40% |
Risk-free interest rate | 4.30% | 3.60% |
Expected dividend yield | 0% | 0% |
Share-Based Compensation - Stat
Share-Based Compensation - Status of Stock Options (Details) - Stock options - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Number of Options | ||||
Outstanding at beginning of the period (in shares) | 6,213,853 | |||
Granted (in shares) | 535,797 | |||
Exercised (in shares) | (398,149) | (214,244) | (725,416) | (753,344) |
Forfeited (in shares) | 0 | |||
Outstanding at the end of the period (in shares) | 6,024,234 | 6,024,234 | ||
Exercisable at the end of the period (in shares) | 5,029,432 | 5,029,432 | ||
Unvested at the end of the period (in shares) | 994,802 | 994,802 | ||
Weighted Average Exercise Price | ||||
Outstanding at beginning of the period (in dollars per share) | $ 136.60 | |||
Granted (in dollars per share) | 236.02 | |||
Exercised (in dollars per share) | 129.89 | |||
Forfeited (in dollars per share) | 0 | |||
Outstanding at the end of the period (in dollars per share) | $ 146.25 | 146.25 | ||
Exercisable at the end of the period (in dollars per share) | 130.15 | 130.15 | ||
Unvested at the end of the period (in dollars per share) | $ 227.64 | $ 227.64 | ||
Weighted Average Remaining Contractual Term (in Years) | ||||
Outstanding at the end of the period (in Years) | 3 years 10 months 24 days | |||
Exercisable at the end of the period (in Years) | 2 years 9 months 18 days | |||
Unvested at the end of the period (in Years) | 9 years 3 months 18 days | |||
Aggregate Intrinsic Value (in millions) | ||||
Outstanding at the end of the period | $ 1,038 | $ 1,038 | ||
Exercisable at the end of the period | 947.6 | 947.6 | ||
Unvested at the end of the period | $ 90.4 | $ 90.4 |
Share-Based Compensation - Shar
Share-Based Compensation - Share-Based Compensation Expense (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-based compensation expense | ||||
Share-based compensation expense (benefit) before taxes | $ 49.7 | $ 13.8 | $ 75.3 | $ 1.4 |
Stock options | ||||
Share-based compensation expense | ||||
Share-based compensation expense (benefit) before taxes | 8.1 | 1.6 | 13.8 | 6.5 |
Related income tax (benefit) expense | (0.3) | (0.1) | (0.5) | (0.3) |
Share-based compensation expense (benefit), net of taxes | 7.8 | 1.5 | 13.3 | 6.2 |
RSUs | ||||
Share-based compensation expense | ||||
Share-based compensation expense (benefit) before taxes | 19.2 | 13.6 | 34.7 | 25.8 |
Related income tax (benefit) expense | (3.5) | (3.2) | (6.8) | (6.1) |
Share-based compensation expense (benefit), net of taxes | 15.7 | 10.4 | 27.9 | 19.7 |
Cost of sales | Stock options | ||||
Share-based compensation expense | ||||
Share-based compensation expense (benefit) before taxes | 0 | 0 | 0 | 0 |
Cost of sales | RSUs | ||||
Share-based compensation expense | ||||
Share-based compensation expense (benefit) before taxes | 1.1 | 1 | 2 | 2 |
Research and development | Stock options | ||||
Share-based compensation expense | ||||
Share-based compensation expense (benefit) before taxes | 0.1 | 0 | 0.2 | 0.1 |
Research and development | RSUs | ||||
Share-based compensation expense | ||||
Share-based compensation expense (benefit) before taxes | 5.8 | 5.1 | 11.4 | 9.8 |
Selling, general, and administrative | Stock options | ||||
Share-based compensation expense | ||||
Share-based compensation expense (benefit) before taxes | 8 | 1.6 | 13.6 | 6.4 |
Selling, general, and administrative | RSUs | ||||
Share-based compensation expense | ||||
Share-based compensation expense (benefit) before taxes | $ 12.3 | $ 7.5 | $ 21.3 | $ 14 |
Share-Based Compensation - St_2
Share-Based Compensation - Stock Options Exercise Data (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Summary of stock option exercise data | ||||
Cash received | $ 94.3 | $ 86.1 | ||
Stock options | ||||
Summary of stock option exercise data | ||||
Number of options exercised (in shares) | 398,149 | 214,244 | 725,416 | 753,344 |
Cash received | $ 52.1 | $ 24.7 | $ 94.3 | $ 86.1 |
Total intrinsic value of options exercised | $ 52.3 | $ 23.8 | $ 88 | $ 95.4 |
Share-Based Compensation - Rest
Share-Based Compensation - Restricted Stock Options Activity and Status (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-Based Compensation | ||||
Share-based compensation expense (benefit) before taxes | $ 49.7 | $ 13.8 | $ 75.3 | $ 1.4 |
RSUs | ||||
Share-Based Compensation | ||||
Number of shares of common stock entitled to recipient upon vesting (in shares) | 1 | 1 | ||
Granted (in shares) | 396,352 | |||
Share-based compensation expense (benefit) before taxes | $ 19.2 | 13.6 | $ 34.7 | $ 25.8 |
Number of RSUs | ||||
Unvested at beginning of the period (in shares) | 964,759 | |||
Granted (in shares) | 396,352 | |||
Vested (in shares) | (140,382) | |||
Forfeited (in shares) | (11,958) | |||
Unvested at the end of the period (in shares) | 1,208,771 | 1,208,771 | ||
Weighted Average Grant Date Fair Value | ||||
Unvested at beginning of the period (in dollars per share) | $ 210.35 | |||
Granted (in dollars per share) | 235.84 | |||
Vested (in dollars per share) | 186.67 | |||
Forfeited (in dollars per share) | 214.60 | |||
Unvested at the end of the period (in dollars per share) | $ 221.41 | $ 221.41 | ||
Unrecognized compensation cost | $ 185.4 | $ 185.4 | ||
Weighted average remaining vesting period | 2 years 8 months 12 days | |||
RSUs with Performance Conditions | ||||
Share-Based Compensation | ||||
Granted (in shares) | 200,000 | 200,000 | ||
Awards granted in period, fair value | $ 47.5 | $ 32.2 | ||
Share-based compensation expense (benefit) before taxes | $ 5.1 | $ 0.9 | $ 7.2 | $ 1.1 |
Number of RSUs | ||||
Granted (in shares) | 200,000 | 200,000 |
Share-Based Compensation - STAP
Share-Based Compensation - STAP Awards (Details) - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Awards granted | |||
Aggregate STAP liability | $ 29.2 | $ 35.4 | |
STAP awards | |||
Awards granted | |||
Grant expiration period from the grant date | 10 years | ||
Award vesting period | 4 years | ||
Weighted-average assumptions used to measure the fair value of the outstanding STAP awards: | |||
Expected term of awards (in years) | 8 months 12 days | 9 months 18 days | |
Expected volatility | 29.40% | 26.10% | |
Risk-free interest rate (as a percent) | 5.20% | 5.40% | |
Expected dividend yield | 0% | 0% | |
Closing price of common stock (in dollars per share) | $ 318.55 | $ 220.75 | $ 219.89 |
Number of Awards | |||
Outstanding at beginning of period (in shares) | 443,058 | ||
Granted (in shares) | 0 | ||
Exercised (in shares) | (273,206) | ||
Forfeited (in shares) | 0 | ||
Outstanding at end of period (in shares) | 169,852 | ||
Exercisable at end of period (in shares) | 169,852 | ||
Weighted Average Grant Date Fair Value | |||
Outstanding at beginning of period (in dollars per share) | $ 149.21 | ||
Granted (in dollars per share) | 0 | ||
Exercised (in dollars per share) | 143.31 | ||
Forfeited (in dollars per share) | 0 | ||
Outstanding at end of period (in dollars per share) | 158.70 | ||
Exercisable at end of period (in dollars per share) | $ 158.70 | ||
Weighted Average Remaining Contractual Term (in Years) | |||
Outstanding at end of year | 8 months 12 days | ||
Exercisable at end of period | 8 months 12 days | ||
Aggregate Intrinsic Value (in millions) | |||
Outstanding at end of period | $ 27.2 | ||
Exercisable at end of period | $ 27.2 |
Share-Based Compensation - Expe
Share-Based Compensation - Expense (Benefit) Recognized (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share based compensation (benefit) expense recognized in connection with the STAP | ||||
Total share-based compensation expense (benefit), before tax | $ 49.7 | $ 13.8 | $ 75.3 | $ 1.4 |
STAP awards | ||||
Share based compensation (benefit) expense recognized in connection with the STAP | ||||
Total share-based compensation expense (benefit), before tax | 21.9 | (1.9) | 25.8 | (31.9) |
Related income tax (benefit) expense | (2.9) | 0.4 | (3.7) | 5.6 |
Share-based compensation expense (benefit), net of taxes | 19 | (1.5) | 22.1 | (26.3) |
Cash payments on awards exercised during the period | 31.9 | 8.4 | ||
Cost of sales | STAP awards | ||||
Share based compensation (benefit) expense recognized in connection with the STAP | ||||
Total share-based compensation expense (benefit), before tax | 0.8 | (0.1) | 1 | (1.5) |
Research and development | STAP awards | ||||
Share based compensation (benefit) expense recognized in connection with the STAP | ||||
Total share-based compensation expense (benefit), before tax | 2.5 | (0.4) | 3 | (4.1) |
Selling, general, and administrative | STAP awards | ||||
Share based compensation (benefit) expense recognized in connection with the STAP | ||||
Total share-based compensation expense (benefit), before tax | $ 18.6 | $ (1.4) | $ 21.8 | $ (26.3) |
Share-Based Compensation - Empl
Share-Based Compensation - Employee Stock Purchase Plan (Details) - ESPP | 6 Months Ended |
Jun. 30, 2024 shares | |
Share-based compensation expense | |
Maximum percentage of compensation employees may contribute for ESPP | 15% |
Share based compensation arrangement by share based payment award, purchase price of common stock, percent | 85% |
Maximum number of shares each eligible employees may purchase in any given offering period (in shares) | 4,000 |
Maximum number of shares authorized to be issued (in shares) | 3,000,000 |
Stockholders_ Equity - Schedule
Stockholders’ Equity - Schedule of Components of Basic and Diluted Earnings (Loss) Per Common Share (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Numerator: | ||||
Net income | $ 278.1 | $ 259.2 | $ 584.7 | $ 500.1 |
Denominator: | ||||
Weighted average outstanding shares - basic (in shares) | 44.4 | 46.9 | 45.7 | 46.6 |
Effect of dilutive securities: | ||||
Stock options, RSUs, and ESPP (in shares) | 3.1 | 2.6 | 2.9 | 3 |
Weighted average shares - diluted (in shares) | 47.5 | 49.5 | 48.6 | 49.6 |
Net income per common share: | ||||
Basic (in dollars per share) | $ 6.26 | $ 5.53 | $ 12.79 | $ 10.73 |
Diluted (in dollars per share) | $ 5.85 | $ 5.24 | $ 12.03 | $ 10.08 |
Stock options and restricted stock units excluded from calculation (in shares) | 1 | 0.2 | 0.8 | 0.1 |
Stockholders_ Equity - Narrativ
Stockholders’ Equity - Narrative (Details) | 1 Months Ended | 6 Months Ended | |||||
Mar. 27, 2024 USD ($) shares | Mar. 25, 2024 USD ($) tranche | Jun. 30, 2024 USD ($) shares | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Sep. 30, 2024 USD ($) | Mar. 31, 2024 USD ($) | |
Equity, Class of Treasury Stock [Line Items] | |||||||
Payments to repurchase common stock | $ 1,000,000,000 | $ 0 | |||||
2024 Share Repurchase Program | |||||||
Equity, Class of Treasury Stock [Line Items] | |||||||
Share repurchase program, authorized amount | $ 1,000,000,000 | ||||||
Accelerated Share Repurchase Agreement | |||||||
Equity, Class of Treasury Stock [Line Items] | |||||||
Share repurchase program, authorized amount | $ 1,000,000,000 | ||||||
Payments to repurchase common stock | $ 1,000,000,000 | ||||||
Stock repurchased during period, shares (in shares) | shares | 3,275,199 | ||||||
Stock repurchase program, percentage of shares to be repurchased | 80% | ||||||
Number of tranches | tranche | 2 | ||||||
Excise tax liability | $ 6,400,000 | 6,400,000 | |||||
Accelerated Share Repurchase Agreement - Tranche One | |||||||
Equity, Class of Treasury Stock [Line Items] | |||||||
Payments to repurchase common stock | $ 300,000,000 | ||||||
Stock repurchased during period, shares (in shares) | shares | 181,772 | ||||||
Forward contract indexed to equity, settlement, cash, amount | $ 300,000,000 | $ 300,000,000 | |||||
Accelerated Share Repurchase Agreement - Tranche Two | |||||||
Equity, Class of Treasury Stock [Line Items] | |||||||
Payments to repurchase common stock | $ 700,000,000 | ||||||
Accelerated Share Repurchase Agreement - Tranche Two | Forecast | |||||||
Equity, Class of Treasury Stock [Line Items] | |||||||
Forward contract indexed to equity, settlement, cash, amount | $ 700,000,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Millions | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |||
Effective income tax rate (as a percent) | 22% | 20% | |
Unrecognized tax benefits, including interest | $ 20.4 | $ 25.7 | |
Decrease in unrecognized tax benefits is reasonably possible | $ 15 |
Segment Information - General (
Segment Information - General (Details) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) segment | Jun. 30, 2023 USD ($) | |
Segment Reporting [Abstract] | ||||
Number of operating segments | segment | 1 | |||
Net product sales, cost of product sales and gross profit by product | ||||
Total revenues | $ 714.9 | $ 596.5 | $ 1,392.6 | $ 1,103.4 |
Cost of sales | 77.8 | 64.1 | 150.7 | 116.4 |
Gross profit (loss) | 637.1 | 532.4 | 1,241.9 | 987 |
Tyvaso DPI | ||||
Net product sales, cost of product sales and gross profit by product | ||||
Total revenues | 258.3 | 193.6 | 485.8 | 312.3 |
Cost of sales | 37.6 | 33 | 70.9 | 53.7 |
Gross profit (loss) | 220.7 | 160.6 | 414.9 | 258.6 |
Nebulized Tyvaso | ||||
Net product sales, cost of product sales and gross profit by product | ||||
Total revenues | 139.9 | 125.3 | 284.9 | 245 |
Cost of sales | 8.4 | 7.4 | 17.3 | 13.6 |
Gross profit (loss) | 131.5 | 117.9 | 267.6 | 231.4 |
Remodulin | ||||
Net product sales, cost of product sales and gross profit by product | ||||
Total revenues | 147.3 | 127.2 | 275.3 | 248.6 |
Cost of sales | 12.8 | 7.3 | 20.7 | 14.2 |
Gross profit (loss) | 134.5 | 119.9 | 254.6 | 234.4 |
Orenitram | ||||
Net product sales, cost of product sales and gross profit by product | ||||
Total revenues | 107.1 | 95.1 | 213.3 | 183.3 |
Cost of sales | 5.9 | 5.7 | 15.1 | 13.3 |
Gross profit (loss) | 101.2 | 89.4 | 198.2 | 170 |
Unituxin | ||||
Net product sales, cost of product sales and gross profit by product | ||||
Total revenues | 51.7 | 44.3 | 110.1 | 93.4 |
Cost of sales | 3.8 | 2.7 | 7.4 | 7.4 |
Gross profit (loss) | 47.9 | 41.6 | 102.7 | 86 |
Adcirca | ||||
Net product sales, cost of product sales and gross profit by product | ||||
Total revenues | 5.7 | 7.5 | 12.1 | 14.8 |
Cost of sales | 2.6 | 3.1 | 5.2 | 6.2 |
Gross profit (loss) | 3.1 | 4.4 | 6.9 | 8.6 |
Other | ||||
Net product sales, cost of product sales and gross profit by product | ||||
Total revenues | 4.9 | 3.5 | 11.1 | 6 |
Cost of sales | 6.7 | 4.9 | 14.1 | 8 |
Gross profit (loss) | $ (1.8) | $ (1.4) | $ (3) | $ (2) |
Segment Information - Geographi
Segment Information - Geographic Information (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Revenues from external customers by geographic area | ||||
Total revenues | $ 714.9 | $ 596.5 | $ 1,392.6 | $ 1,103.4 |
Total Tyvaso | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 398.2 | 318.9 | 770.7 | 557.3 |
Tyvaso DPI | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 258.3 | 193.6 | 485.8 | 312.3 |
Nebulized Tyvaso | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 139.9 | 125.3 | 284.9 | 245 |
Remodulin | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 147.3 | 127.2 | 275.3 | 248.6 |
Orenitram | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 107.1 | 95.1 | 213.3 | 183.3 |
Unituxin | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 51.7 | 44.3 | 110.1 | 93.4 |
Adcirca | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 5.7 | 7.5 | 12.1 | 14.8 |
Other | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 4.9 | 3.5 | 11.1 | 6 |
UNITED STATES | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 675.2 | 562 | 1,316.7 | 1,031.7 |
UNITED STATES | Total Tyvaso | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 388.5 | 313.2 | 749.7 | 547.6 |
UNITED STATES | Tyvaso DPI | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 258.3 | 193.6 | 485.8 | 312.3 |
UNITED STATES | Nebulized Tyvaso | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 130.2 | 119.6 | 263.9 | 235.3 |
UNITED STATES | Remodulin | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 122.5 | 103.5 | 230.8 | 196.7 |
UNITED STATES | Orenitram | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 107.1 | 95.1 | 213.3 | 183.3 |
UNITED STATES | Unituxin | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 46.8 | 39.5 | 100.2 | 83.8 |
UNITED STATES | Adcirca | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 5.7 | 7.5 | 12.1 | 14.8 |
UNITED STATES | Other | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 4.6 | 3.2 | 10.6 | 5.5 |
Non-US [Member] | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 39.7 | 34.5 | 75.9 | 71.7 |
Non-US [Member] | Total Tyvaso | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 9.7 | 5.7 | 21 | 9.7 |
Non-US [Member] | Tyvaso DPI | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 0 | 0 | 0 | 0 |
Non-US [Member] | Nebulized Tyvaso | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 9.7 | 5.7 | 21 | 9.7 |
Non-US [Member] | Remodulin | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 24.8 | 23.7 | 44.5 | 51.9 |
Non-US [Member] | Orenitram | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 0 | 0 | 0 | 0 |
Non-US [Member] | Unituxin | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 4.9 | 4.8 | 9.9 | 9.6 |
Non-US [Member] | Adcirca | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 0 | 0 | 0 | 0 |
Non-US [Member] | Other | ||||
Revenues from external customers by geographic area | ||||
Total revenues | $ 0.3 | $ 0.3 | $ 0.5 | $ 0.5 |
Segment Information - Concentra
Segment Information - Concentration Risk (Details) - Revenue from Contract with Customer Benchmark - Customer Concentration | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Distributor 1 | ||||
Segment Information | ||||
Concentration risk, percentage | 51% | 52% | 51% | 51% |
Distributor 2 | ||||
Segment Information | ||||
Concentration risk, percentage | 36% | 34% | 35% | 33% |
Litigation (Details)
Litigation (Details) $ in Thousands | 1 Months Ended | |||
Oct. 31, 2021 claim | Nov. 30, 2020 USD ($) | Jun. 30, 2020 | Mar. 31, 2020 petition | |
Sandoz Inc. | Smiths Medical ASD, Inc. | ||||
Litigation | ||||
Payments for legal settlements | $ | $ 4,250 | |||
Liquidia Technologies, Inc. | ||||
Litigation | ||||
Number of petitions | petition | 2 | |||
Number of claims with proven invalidity | 7 | |||
Number of claims without proven invalidity | 2 | |||
Time period to file a preliminary response to the petitions | 45 days | |||
Maximum period for which the FDA is automatically precluded from approving ANDA | 30 months |
Business Combination (Details)
Business Combination (Details) - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | |
Oct. 29, 2023 | Jun. 30, 2024 | |
Asset Acquisition [Line Items] | ||
Contingent consideration, measurement period adjustment | $ 1.5 | |
Miromatrix | ||
Asset Acquisition [Line Items] | ||
Business acquisition, share price (in dollars per share) | $ 3.25 | |
Payments to acquire businesses, gross | $ 89.1 | |
Business acquisition, contingent consideration, amount per share (in dollars per share) | $ 1.75 | |
Business acquisition, contingent consideration, aggregate amount | $ 54 | |
Contingent consideration, liability | 2.5 | |
Contingent consideration, measurement period adjustment | $ 1.4 |