Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2020 | Jul. 22, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2020 | |
Document Transition Report | false | |
Entity File Number | 0-26301 | |
Entity Registrant Name | United Therapeutics Corporation | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001082554 | |
Amendment Flag | false | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 52-1984749 | |
Entity Address, Address Line One | 1040 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 $0.01 per share | |
Trading Symbol | UTHR | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 44,411,794 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Millions | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 685.4 | $ 738.4 |
Marketable investments | 875.3 | 747.5 |
Accounts receivable, no allowance for 2020 and 2019 | 172 | 151.4 |
Inventories, net | 89.7 | 93.4 |
Other current assets | 72 | 133.8 |
Total current assets | 1,894.4 | 1,864.5 |
Marketable investments | 1,009.4 | 767.5 |
Goodwill and other intangible assets, net | 158.2 | 158.3 |
Property, plant, and equipment, net | 744.2 | 738.5 |
Deferred tax assets, net | 245.8 | 230 |
Other non-current assets | 167.4 | 154.6 |
Total assets | 4,219.4 | 3,913.4 |
Current liabilities: | ||
Accounts payable and accrued expenses | 152.6 | 148.4 |
Line of credit (current) | 0 | 250 |
Share tracking awards plan | 61 | 25 |
Other current liabilities | 41.4 | 39.6 |
Total current liabilities | 255 | 463 |
Line of credit (non-current) | 800 | 600 |
Other non-current liabilities | 70.7 | 70 |
Total liabilities | 1,125.7 | 1,133 |
Stockholders’ equity: | ||
Preferred stock, value issued | 0 | 0 |
Common stock, par value $.01, 245,000,000 shares authorized, 70,976,064 and 70,503,775 shares issued, and 44,356,848 and 43,884,559 shares outstanding at June 30, 2020 and December 31, 2019, respectively | 0.7 | 0.7 |
Additional paid-in capital | 2,105.1 | 2,047.9 |
Accumulated other comprehensive loss | (2.1) | (14.2) |
Treasury stock, 26,619,216 shares at June 30, 2020 and December 31, 2019 | (2,579.2) | (2,579.2) |
Retained earnings | 3,569.2 | 3,325.2 |
Total stockholders’ equity | 3,093.7 | 2,780.4 |
Total liabilities and stockholders’ equity | $ 4,219.4 | $ 3,913.4 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 |
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 | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 245,000,000 | 245,000,000 |
Common stock, shares issued | 70,976,064 | 70,503,775 |
Common stock, shares outstanding | 44,356,848 | 43,884,559 |
Treasury stock (in shares) | 26,619,216 | 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, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Revenues: | ||||
Total revenues | $ 362 | $ 373.6 | $ 718.3 | $ 736.2 |
Operating expenses: | ||||
Cost of product sales | 25.9 | 26.7 | 49.3 | 55.8 |
Research and development | 89.7 | 85.9 | 162.9 | 983.3 |
Selling, general, and administrative | 105.9 | 39.6 | 198.9 | 131.6 |
Total operating expenses | 221.5 | 152.2 | 411.1 | 1,170.7 |
Operating income (loss) | 140.5 | 221.4 | 307.2 | (434.5) |
Interest income | 7.2 | 10.8 | 17.2 | 20.6 |
Interest expense | (5.6) | (12.2) | (13.8) | (22.5) |
Other (expense) income, net | (8.2) | 30.4 | 0.5 | 36.2 |
Impairments of investments in privately-held companies | 0 | 0 | (5.6) | 0 |
Total other (expense) income, net | (6.6) | 29 | (1.7) | 34.3 |
Income (loss) before income taxes | 133.9 | 250.4 | 305.5 | (400.2) |
Income tax (expense) benefit | (26.8) | (45.3) | (60.7) | 110.7 |
Net income (loss) | $ 107.1 | $ 205.1 | $ 244.8 | $ (289.5) |
Net income (loss) per common share: | ||||
Basic (in dollars per share) | $ 2.43 | $ 4.68 | $ 5.56 | $ (6.61) |
Diluted (in dollars per share) | $ 2.41 | $ 4.66 | $ 5.53 | $ (6.61) |
Weighted average number of common shares outstanding: | ||||
Basic (in shares) | 44.1 | 43.8 | 44 | 43.8 |
Diluted (in shares) | 44.4 | 44 | 44.3 | 43.8 |
Net product sales | ||||
Revenues: | ||||
Total revenues | $ 362 | $ 373.6 | $ 718.3 | $ 736.2 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Comprehensive income: | ||||
Net income (loss) | $ 107.1 | $ 205.1 | $ 244.8 | $ (289.5) |
Defined benefit pension plan: | ||||
Actuarial (loss) gain arising during period, net of tax | 0 | (0.6) | 0.2 | (0.6) |
Amortization of actuarial gain and prior service cost included in net periodic pension cost, net of tax | 0.3 | (1.6) | 0.6 | (1.5) |
Total defined benefit pension plan, net of tax | 0.3 | (2.2) | 0.8 | (2.1) |
Unrealized gains on available-for-sale securities, net of tax | 1.1 | 2.4 | 11.3 | 5 |
Other comprehensive income, net of tax | 1.4 | 0.2 | 12.1 | 2.9 |
Comprehensive income (loss) | $ 108.5 | $ 205.3 | $ 256.9 | $ (286.6) |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) shares in Millions, $ in Millions | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Treasury Stock | Retained Earnings | Cumulative Effect, Period of Adoption, Adjustment | Cumulative Effect, Period of Adoption, AdjustmentRetained Earnings | |
Balance at Dec. 31, 2018 | $ 2,788.6 | $ 0.7 | $ 1,940.2 | $ (7.9) | $ (2,579.2) | $ 3,434.8 | $ (5.1) | $ (5.1) | |
Balance (in shares) at Dec. 31, 2018 | 70.2 | ||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||
Net income (loss) | (289.5) | (289.5) | |||||||
Unrealized gains on available-for-sale securities | 5 | 5 | |||||||
Defined benefit pension plan | (2.1) | (2.1) | |||||||
Shares issued under employee stock purchase plan | 2.2 | 2.2 | |||||||
Restricted stock units withheld for taxes | (1.9) | (1.9) | |||||||
Common stock issued for RSUs vested (in shares) | 0.1 | ||||||||
Exercise of stock options | 9.9 | 9.9 | |||||||
Exercise of stock options (in shares) | 0.2 | ||||||||
Share-based compensation | 40.5 | 40.5 | |||||||
Reclassification from temporary equity to permanent equity | [1] | 10.8 | 10.8 | ||||||
Balance at Jun. 30, 2019 | 2,558.4 | $ 0.7 | 2,001.7 | (5) | (2,579.2) | 3,140.2 | |||
Balance (in shares) at Jun. 30, 2019 | 70.5 | ||||||||
Balance at Mar. 31, 2019 | 2,319 | $ 0.7 | 1,967.6 | (5.2) | (2,579.2) | 2,935.1 | |||
Balance (in shares) at Mar. 31, 2019 | 70.4 | ||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||
Net income (loss) | 205.1 | 205.1 | |||||||
Unrealized gains on available-for-sale securities | 2.4 | 2.4 | |||||||
Defined benefit pension plan | (2.2) | (2.2) | |||||||
Common stock issued for RSUs vested (in shares) | 0.1 | ||||||||
Exercise of stock options | 1.1 | 1.1 | |||||||
Share-based compensation | 22.2 | 22.2 | |||||||
Reclassification from temporary equity to permanent equity | [2] | 10.8 | 10.8 | ||||||
Balance at Jun. 30, 2019 | 2,558.4 | $ 0.7 | 2,001.7 | (5) | (2,579.2) | 3,140.2 | |||
Balance (in shares) at Jun. 30, 2019 | 70.5 | ||||||||
Balance at Dec. 31, 2019 | 2,780.4 | $ 0.7 | 2,047.9 | (14.2) | (2,579.2) | 3,325.2 | $ (0.8) | $ (0.8) | |
Balance (in shares) at Dec. 31, 2019 | 70.5 | ||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||
Net income (loss) | 244.8 | 244.8 | |||||||
Unrealized gains on available-for-sale securities | 11.3 | 11.3 | |||||||
Defined benefit pension plan | 0.8 | 0.8 | |||||||
Shares issued under employee stock purchase plan | 2.5 | 2.5 | |||||||
Restricted stock units withheld for taxes | (3.5) | (3.5) | |||||||
Common stock issued for RSUs vested (in shares) | 0.1 | ||||||||
Exercise of stock options | 22.4 | 22.4 | |||||||
Exercise of stock options (in shares) | 0.4 | ||||||||
Share-based compensation | 35.8 | 35.8 | |||||||
Balance at Jun. 30, 2020 | 3,093.7 | $ 0.7 | 2,105.1 | (2.1) | (2,579.2) | 3,569.2 | |||
Balance (in shares) at Jun. 30, 2020 | 71 | ||||||||
Balance at Mar. 31, 2020 | 2,948.5 | $ 0.7 | 2,068.4 | (3.5) | (2,579.2) | 3,462.1 | |||
Balance (in shares) at Mar. 31, 2020 | 70.6 | ||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||
Net income (loss) | 107.1 | 107.1 | |||||||
Unrealized gains on available-for-sale securities | 1.1 | 1.1 | |||||||
Defined benefit pension plan | 0.3 | 0.3 | |||||||
Restricted stock units withheld for taxes | (0.1) | (0.1) | |||||||
Exercise of stock options | 21.7 | 21.7 | |||||||
Exercise of stock options (in shares) | 0.4 | ||||||||
Share-based compensation | 15.1 | 15.1 | |||||||
Balance at Jun. 30, 2020 | $ 3,093.7 | $ 0.7 | $ 2,105.1 | $ (2.1) | $ (2,579.2) | $ 3,569.2 | |||
Balance (in shares) at Jun. 30, 2020 | 71 | ||||||||
[1] | Pursuant to a license agreement with Toray, we issued 200,000 shares of our common stock (which have since split into 400,000 shares) to Toray in 2007, and provided Toray the Put Right, which resulted in classification of such shares within temporary equity. During the six months ended June 30, 2019, we terminated our license agreement with Toray and the Put Right also terminated. As a result, upon the termination of the license agreement, we reclassified $10.8 million from temporary equity to additional paid-in capital during the six months ended June 30, 2019. | ||||||||
[2] | Pursuant to a license agreement with Toray Industries Inc. (Toray), we issued 200,000 shares of our common stock (which have since split into 400,000 shares) to Toray in 2007, and provided Toray the right to require us to repurchase the shares at a price of $27.21 per share (the Put Right), which resulted in classification of such shares within temporary equity. During the three months ended June 30, 2019, we terminated our license agreement with Toray and the Put Right also terminated. As a result, upon the termination of the license agreement, we reclassified $10.8 million from temporary equity to additional paid-in capital during the quarter ended June 30, 2019. |
CONSOLIDATED STATEMENTS OF ST_2
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) $ in Millions | Jun. 30, 2019USD ($)$ / sharesshares |
Common stock subject to repurchase | $ | $ 10.8 |
Temporary Equity Common Stocks Subject to Repurchase | |
Common stock issued (in shares) | 200,000 |
Common stock issued split (in shares) | 400,000 |
Repurchase price (in dollars per share) | $ / shares | $ 27.21 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Millions | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Cash flows from operating activities: | ||
Net income (loss) | $ 244.8 | $ (289.5) |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||
Depreciation and amortization | 25 | 20.7 |
Share-based compensation expense (benefit) | 82.6 | (8) |
Impairments of investments in privately-held companies | 5.6 | 0 |
Intangible asset impairment charges | 0 | 8.8 |
Other | (13.9) | (37) |
Changes in operating assets and liabilities: | ||
Accounts receivable | (20.6) | (5.3) |
Inventories | 10.6 | 4.4 |
Accounts payable and accrued expenses | 2.6 | (3) |
Other assets and liabilities | 41.9 | (185.6) |
Net cash provided by (used in) operating activities | 378.6 | (494.5) |
Cash flows from investing activities: | ||
Purchases of property, plant, and equipment | (31.2) | (45.4) |
Sales/maturities of held-to-maturity investments | 0 | 38.2 |
Purchases of available-for-sale investments | (1,094.3) | (519) |
Sales/maturities of available-for-sale investments | 708.3 | 430.3 |
Sales of investments in equity securities | 14.2 | 0 |
Purchase of investments in privately-held companies | 0 | (7) |
Net cash used in investing activities | (403) | (102.9) |
Cash flows from financing activities: | ||
Proceeds from line of credit | 0 | 800 |
Repayment of line of credit | (50) | 0 |
Payments of debt issuance costs | 0 | (0.7) |
Proceeds from the exercise of stock options | 22.4 | 9.9 |
Proceeds from the issuance of stock under employee stock purchase plan | 2.5 | 2.2 |
Restricted stock units withheld for taxes | (3.5) | (1.9) |
Net cash (used in) provided by financing activities | (28.6) | 809.5 |
Net (decrease) increase in cash and cash equivalents | (53) | 212.1 |
Cash and cash equivalents, beginning of period | 738.4 | 669.2 |
Cash and cash equivalents, end of period | 685.4 | 881.3 |
Supplemental cash flow information: | ||
Cash paid for interest | 12.4 | 20.6 |
Cash paid for income taxes | 44 | 62.7 |
Non-cash investing and financing activities: | ||
Non-cash additions to property, plant, and equipment | $ 6.9 | $ 4 |
Organization and Business Descr
Organization and Business Description | 6 Months Ended |
Jun. 30, 2020 | |
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. We have approval from the U.S. Food and Drug Administration (FDA) to market the following therapies: Remodulin ® (treprostinil) Injection (Remodulin), Tyvaso ® (treprostinil) Inhalation Solution (Tyvaso), Orenitram ® (treprostinil) Extended-Release Tablets (Orenitram), Unituxin ® (dinutuximab) Injection (Unituxin), and Adcirca ® (tadalafil) Tablets (Adcirca). Our only significant revenues outside the United States are derived from sales of Remodulin in Europe. 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, 2020 | |
Basis of Presentation | |
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 (GAAP) 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, 2019 , as filed with the SEC on February 26, 2020. 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, 2020 and December 31, 2019 , our statements of operations, comprehensive income, and stockholders’ equity for the three- and six-month periods ended June 30, 2020 and 2019 and statements of cash flows for the six-month periods ended June 30, 2020 and 2019 . Interim results are not necessarily indicative of results for an entire year. Recently Issued Accounting Standards Accounting Standards Adopted During the Period In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (ASU 2016-13), which introduces new guidance for estimating credit losses on certain types of financial instruments based on expected losses and the timing of the recognition of such losses. ASU 2016-13 is effective for interim and annual reporting periods beginning after December 15, 2019. We adopted this standard on January 1, 2020 using the modified retrospective method for financial assets measured at amortized cost, including our net investment in a sales-type lease, financing receivables, and trade receivables. Upon adoption of the new standard, we recorded an allowance for credit losses of $1.1 million related to our net investment in a lease using an estimated default rate for the lessee over the lease term. The cumulative-effect adjustment resulted in a decrease to retained earnings of $0.8 million , which is net of a tax benefit. During the first quarter of 2020, we recognized an impairment charge of $1.5 million on a note receivable due to the expected loss from future payments as a result of economic uncertainty arising from the negative effects which the COVID-19 pandemic has had on the global economy and financial markets. We did not recognize any further impairment of this note receivable during the second quarter of 2020. We recorded this impairment charge within “other (expense) income, net” on our consolidated statements of operations. In January 2017, the FASB issued ASU No. 2017-04, Intangibles-Goodwill and Other: Simplifying the Test for Goodwill Impairment (ASU 2017-04), which simplifies how an entity is required to test goodwill for impairment. ASU 2017-04 requires that a goodwill impairment be measured by the amount by which a reporting unit’s carrying value exceeds its fair value, with the amount of impairment not to exceed the carrying amount of goodwill. ASU 2017-04 is effective for goodwill impairment tests in fiscal years beginning after December 15, 2019, and for interim periods within those fiscal years, and must be adopted on a prospective basis. We adopted the new standard on January 1, 2020, with no material impact on our financial statements. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement (ASU 2018-13), which eliminates, adds, and modifies certain disclosure requirements for fair value measurements. ASU 2018-13 is effective for interim and annual reporting periods beginning after December 15, 2019. We adopted the new standard on January 1, 2020, with no material impact on our financial statements. Accounting Standards Not Yet Adopted In August 2018, the FASB issued ASU No. 2018-14, Compensation-Retirement Benefits-Defined Benefit Plans-General (Topic 715-20): Disclosure Framework-Changes to the Disclosure Requirements for Defined Benefit Plans (ASU 2018-14). The standard modifies the disclosure requirements for employers that sponsor defined benefit pension or other postretirement plans. ASU 2018-14 is effective for fiscal years beginning after December 15, 2020. Early adoption is permitted. We do not expect the adoption of this guidance to have a material impact on our financial statements. In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes (ASU 2019-12) , which simplifies the accounting for income taxes by removing certain exceptions to the general principles of Topic 740, Income Taxes, and also improves consistency of application by clarifying and amending existing guidance. ASU 2019-12 is effective for fiscal years beginning after December 15, 2020, with early adoption permitted. We are currently evaluating the impact of this guidance on our financial statements. In January 2020, the FASB issued ASU 2020-01, Investments-Equity Securities (Topic 321), Investments-Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815)-Clarifying the Interactions between Topic 321, Topic 323, and Topic 815 (a consensus of the Emerging Issues Task Force) , which addresses the accounting for the transition into and out of the equity method and measuring certain purchased options and forward contracts to acquire investments. ASU 2020-01 is effective for fiscal years beginning after December 15, 2020, with early adoption permitted. We do not expect the adoption of this guidance to have a material impact on our financial statements. |
Investments
Investments | 6 Months Ended |
Jun. 30, 2020 | |
Investments [Abstract] | |
Investments | Investments Marketable Investments Available-for-Sale Debt Securities Available-for-sale debt securities are recorded at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive income in stockholders’ equity, until realized. Available-for-sale debt securities consisted of the following (in millions): As of June 30, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. government and agency securities $ 1,567.9 $ 14.6 $ (0.1 ) $ 1,582.4 Corporate debt securities 265.9 4.5 — 270.4 Total $ 1,833.8 $ 19.1 $ (0.1 ) $ 1,852.8 Reported under the following captions on our consolidated balance sheets: Current marketable investments 843.4 Non-current marketable investments 1,009.4 Total $ 1,852.8 As of December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. government and agency securities $ 1,225.2 $ 2.9 $ (0.2 ) $ 1,227.9 Corporate debt securities 222.4 1.7 — 224.1 Total $ 1,447.6 $ 4.6 $ (0.2 ) $ 1,452.0 Reported under the following captions on our consolidated balance sheets: Current marketable investments 684.5 Non-current marketable investments 767.5 Total $ 1,452.0 The following table summarizes the contractual maturities of available-for-sale marketable investments (in millions): As of June 30, 2020 Amortized Cost Fair Value Due within one year $ 838.6 $ 843.4 Due in one to three years 995.2 1,009.4 Total $ 1,833.8 $ 1,852.8 As of December 31, 2019 Amortized Cost Fair Value Due within one year $ 683.3 $ 684.5 Due in one to three years 764.3 767.5 Total $ 1,447.6 $ 1,452.0 Investments in Equity Securities with Readily Determinable Fair Values We held investments in equity securities with readily determinable fair values of $32.0 million and $63.0 million as of June 30, 2020 and December 31, 2019 , respectively, which are included in current marketable investments on our consolidated balance sheets. Changes in the fair value of publicly traded equity securities are recorded on our consolidated statements of operations within “other (expense) income, net”. Refer to Note 4 —Fair Value Investments . Investments in Privately-Held Companies As of June 30, 2020 and December 31, 2019 , we maintained non-controlling equity investments in privately-held companies of $102.9 million and $86.0 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 on 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 . During the first quarter of 2020, one of these privately-held companies raised additional capital by issuing equity securities similar to ours at an increased valuation, which resulted in an increase of $22.5 million in the value of our investment. The gain was recorded within “other (expense) income, net” on our consolidated statements of operations for the six months ended June 30, 2020. During the first quarter of 2020, we observed an indicator of impairment for our investments in two of these companies, which caused us to recognize aggregate impairment charges of $5.6 million . One of these companies suspended operations during the first quarter of 2020, which caused us to recognize an impairment charge equal to the entire value of our investment in this company. The other company experienced a decline in its business arising from the negative effects of the COVID-19 pandemic during the first quarter of 2020, which caused us to recognize an impairment charge equal to a portion of the value of our investment in this company. We did not recognize any further impairment in these investments during the second quarter of 2020. These impairment charges were recorded within impairments of investments in privately-held companies on our consolidated statements of operations for the six months ended June 30, 2020. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2020 | |
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, 2020 Level 1 Level 2 Level 3 Balance Assets Money market funds (1) $ 215.1 $ — $ — $ 215.1 Time deposits (2) — 88.0 — 88.0 U.S. government and agency securities (3) — 1,582.3 — 1,582.3 Corporate debt securities (3) — 270.5 — 270.5 Equity securities (4) 32.0 — — 32.0 Total assets $ 247.1 $ 1,940.8 $ — $ 2,187.9 Liabilities Contingent consideration (5) — — 13.6 13.6 Total liabilities $ — $ — $ 13.6 $ 13.6 As of December 31, 2019 Level 1 Level 2 Level 3 Balance Assets Money market funds (1) $ 270.0 $ — $ — $ 270.0 Time deposits (2) — 87.3 — 87.3 U.S. government and agency securities (3) — 1,227.9 — 1,227.9 Corporate debt securities (3) — 224.1 — 224.1 Equity securities (4) 63.0 — — 63.0 Total assets $ 333.0 $ 1,539.3 $ — $ 1,872.3 Liabilities Contingent consideration (5) — — 13.4 13.4 Total liabilities $ — $ — $ 13.4 $ 13.4 ________________________ (1) Included in cash and cash equivalents on our consolidated balance sheets. (2) Included in cash and cash equivalents and current marketable investments on our consolidated balance sheets. The fair value of these securities is principally measured or corroborated by trade data for identical securities in 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 cash and cash equivalents and current and non-current marketable investments on our consolidated balance sheets. Refer to Note 3 —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. (4) Included in current marketable investments on 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, 2020 , we recognized $8.9 million and $15.0 million of net unrealized and realized losses on these securities. During the three and six months ended June 30, 2019 , we recognized $29.5 million and $32.5 million of net unrealized gains on these securities. We recorded these gains and losses on our consolidated statements of operations within “other (expense) income, net”. Refer to Note 3 —Investments—Investments in Equity Securities with Readily Determinable Fair Values. (5) Included in non-current liabilities on 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 change in the fair value of our contingent consideration obligations for the three and six months ended June 30, 2020 was not material. Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, accounts receivable, 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. Refer to 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, 2020 | |
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, December 31, Raw materials $ 18.9 $ 21.1 Work-in-progress 27.9 29.1 Finished goods 42.9 43.2 Total inventories $ 89.7 $ 93.4 |
Goodwill and Other Intangible A
Goodwill and Other Intangible Assets | 6 Months Ended |
Jun. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Other Intangible Assets | Goodwill and Other Intangible Assets Goodwill and other intangible assets comprise the following (in millions): As of June 30, 2020 As of December 31, 2019 Gross Accumulated Amortization Net Gross Accumulated Amortization Net Goodwill $ 28.0 $ — $ 28.0 $ 28.0 $ — $ 28.0 Other intangible assets: Technology, patents, and trade names 6.7 (5.4 ) 1.3 6.7 (5.3 ) 1.4 In-process research and development (1) 128.9 — 128.9 128.9 — 128.9 Total $ 163.6 $ (5.4 ) $ 158.2 $ 163.6 $ (5.3 ) $ 158.3 (1) In April 2020, the FDA issued a complete response letter related to our Trevyent ® new drug application (NDA) indicating that some of the deficiencies previously raised by the FDA had not yet been addressed to its satisfaction. We determined this to be a potential indicator of impairment of our in-process research and development (IPR&D) asset related to Trevyent, which had a carrying value of $107.3 million as of June 30, 2020 . We obtained a third-party valuation of the IPR&D asset to estimate its fair value using the income approach, together with Level 3 valuation inputs, including estimated future cash flows and a discount rate. Significant judgment is required to determine the probability of success of a drug candidate as well as the associated revenue from a future product launch. Based on this valuation, the fair value was in excess of carrying value; therefore, the IPR&D asset was no |
Debt
Debt | 6 Months Ended |
Jun. 30, 2020 | |
Debt Disclosure [Abstract] | |
Debt | Debt Unsecured Revolving Credit Facility In June 2018, 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, providing for: (1) an unsecured revolving credit facility of up to $1.0 billion ; and (2) a second unsecured revolving credit facility of up to $500.0 million (which facilities may, at our request, be increased by up to $300.0 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 June 2019, we extended the maturity date of the Credit Agreement by one year , to June 2024. At our option, amounts borrowed under the Credit Agreement bear interest at either the LIBOR rate 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 LIBOR plus an applicable margin. As of December 31, 2019 , our outstanding aggregate principal balance was $850.0 million , of which $250.0 million was classified as a current liability because, as of such date, we intended to repay that amount within one year . During the six months ended June 30, 2020 , we paid down $50.0 million of our balance under the Credit Agreement. This brought our aggregate outstanding balance to $800.0 million as of June 30, 2020 , all of which was classified as a non-current liability because we no longer intend to repay any portion of this amount within one year . We decided not to repay a portion of the loan within one year out of an abundance of caution given the uncertainty surrounding the current COVID-19 pandemic and its potential impact on our business. The Credit Agreement contains customary events of default and customary affirmative and negative covenants. As of June 30, 2020 , we were in compliance with these covenants. Lung Biotechnology PBC is our only subsidiary that guarantees our obligations under the Credit Agreement though, from time to time, one or more of our other subsidiaries may be required to guarantee our obligations. In connection with the Credit Agreement, we capitalized debt issuance costs, which are being amortized to interest expense over the contractual term of the Credit Agreement. As of June 30, 2020 , $3.4 million was recorded in other current assets and $7.9 million in other non-current assets on our consolidated balance sheets. During the three and six months ended June 30, 2020 , we recorded interest expense of $5.6 million and $13.7 million , respectively, related to the Credit Agreement. During the three and six months ended June 30, 2019 , we recorded interest expense of $12.2 million and $22.5 million , respectively, related to the Credit Agreement. |
Share-Based Compensation
Share-Based Compensation | 6 Months Ended |
Jun. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Compensation | Share-Based Compensation As of June 30, 2020 , 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 (as amended to date, the 2015 Plan). The 2015 Plan provides for the issuance of up to 10,000,000 shares of our common stock pursuant to awards granted under the 2015 Plan, which includes the 500,000 shares added pursuant to an amendment and restatement of the 2015 Plan approved by our shareholders in June 2020. 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 under the 2015 Plan, and we grant restricted stock units to newly-hired employees under the 2019 Inducement Plan. Refer to the sections entitled Stock Options and Restricted Stock Units below. We previously issued awards under the United Therapeutics Corporation Share Tracking Awards Plan (2008 STAP) and the United Therapeutics Corporation 2011 Share Tracking Awards Plan (2011 STAP). We refer to the 2008 STAP and the 2011 STAP collectively as the “STAP” and awards outstanding under either of these plans as “STAP awards.” Refer to the section entitled Share Tracking Awards Plans below. 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. Refer to the section entitled Employee Stock Purchase Plan below. The following table reflects the components of share-based compensation expense (benefit) recognized in our consolidated statements of operations (in millions): Three Months Ended Six Months Ended 2020 2019 2020 2019 Stock options $ 9.2 $ 18.1 $ 25.6 $ 33.8 Restricted stock units 5.5 3.8 9.5 6.0 STAP awards 36.7 (59.4 ) 46.8 (48.4 ) Employee stock purchase plan 0.4 0.3 0.7 0.6 Total share-based compensation expense (benefit) before tax $ 51.8 $ (37.2 ) $ 82.6 $ (8.0 ) 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. 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, 2020 and June 30, 2019 : June 30, June 30, Expected term of awards (in years) 5.6 5.8 Expected volatility 33.4 % 33.8 % Risk-free interest rate 0.5 % 2.4 % 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, 2020 is presented below: Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in Years) Aggregate Outstanding at January 1, 2020 8,088,680 $ 123.34 Granted 57,879 111.77 Exercised (346,549 ) 64.54 Forfeited/canceled (8,779 ) 135.48 Outstanding at June 30, 2020 7,791,231 $ 125.86 6.0 $ 33.8 Exercisable at June 30, 2020 4,974,974 $ 127.46 5.5 $ 23.3 Unvested at June 30, 2020 2,816,257 $ 123.04 7.0 $ 10.5 The weighted average fair value of a stock option granted during each of the six- month periods ended June 30, 2020 and June 30, 2019 , was $35.53 and $39.63 , respectively. These stock options have an aggregate grant date fair value of $2.1 million and $82.5 million , respectively. The total grant date fair value of stock options that vested during the six- month periods ended June 30, 2020 and June 30, 2019 was $72.7 million and $36.3 million , respectively. Total share-based compensation expense relating to stock options is recorded as follows (in millions): Three Months Ended Six Months Ended 2020 2019 2020 2019 Cost of product sales $ 0.1 $ 0.2 $ 0.3 $ 0.4 Research and development 0.4 0.9 1.3 1.8 Selling, general, and administrative 8.7 17.0 24.0 31.6 Share-based compensation expense before taxes 9.2 18.1 25.6 33.8 Related income tax expense (benefit) 1.4 (4.1 ) (2.3 ) (7.6 ) Share-based compensation expense, net of taxes $ 10.6 $ 14.0 $ 23.3 $ 26.2 As of June 30, 2020 , unrecognized compensation cost relating to stock options was $66.4 million . Unvested outstanding stock options as of June 30, 2020 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 2020 2019 2020 2019 Number of options exercised 333,049 25,000 346,549 191,508 Cash received $ 21.7 $ 1.1 $ 22.4 $ 9.9 Total intrinsic value of options exercised $ 18.1 $ 1.2 $ 18.7 $ 11.5 Restricted Stock Units Each restricted stock unit entitles the recipient to one share of our common stock upon vesting. We measure the fair value of restricted stock units using the stock price on the date of grant. Share-based compensation expense for the restricted stock units is recorded ratably over their vesting period. A summary of the activity with respect to, and status of, restricted stock units during the six- month period ended June 30, 2020 is presented below: Number of Restricted Stock Units Weighted Average Grant Date Fair Value Weighted Average Remaining Contractual Term (in Years) Aggregate Unvested at January 1, 2020 310,725 $ 112.24 Granted 277,379 94.16 Vested (127,167 ) 108.63 Forfeited/canceled (7,080 ) 107.53 Unvested at June 30, 2020 453,857 $ 102.28 9.2 $ 54.9 Total share-based compensation expense relating to restricted stock units is recorded as follows (in millions): Three Months Ended Six Months Ended 2020 2019 2020 2019 Cost of product sales $ 0.4 $ 0.3 $ 0.7 $ 0.5 Research and development 2.1 1.2 3.5 1.9 Selling, general, and administrative 3.0 2.3 5.3 3.6 Share-based compensation expense before taxes 5.5 3.8 9.5 6.0 Related income tax benefit (1.3 ) (0.9 ) (2.2 ) (1.4 ) Share-based compensation expense, net of taxes $ 4.2 $ 2.9 $ 7.3 $ 4.6 As of June 30, 2020 , unrecognized compensation cost related to the grant of restricted stock units was $40.0 million . Unvested outstanding restricted stock units as of June 30, 2020 had a weighted average remaining vesting period of 2.1 years . Share Tracking Awards Plans 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 tenth anniversary of the grant date. We discontinued the issuance of STAP awards in June 2015 and all outstanding STAP awards have been fully vested since June 2019. The aggregate STAP liability balance was $61.0 million and $25.0 million at June 30, 2020 and December 31, 2019 , respectively, all of which was classified as a current liability on 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 (benefit) 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, June 30, Expected term of awards (in years) 1.9 2.3 Expected volatility 32.1 % 28.9 % Risk-free interest rate 0.2 % 1.7 % Expected dividend yield — % — % The closing price of our common stock was $121.00 and $78.06 on June 30, 2020 and June 30, 2019 , respectively. The closing price of our common stock was $88.08 on December 31, 2019 . A summary of the activity and status of STAP awards during the six- month period ended June 30, 2020 is presented below: Number of Awards Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in Years) Aggregate Intrinsic Value (in millions) Outstanding at January 1, 2020 2,622,328 $ 109.10 Granted — — Exercised (239,312 ) 63.40 Forfeited/canceled (17,054 ) 123.11 Outstanding at June 30, 2020 2,365,962 $ 113.62 3.7 $ 60.8 Exercisable at June 30, 2020 2,355,962 $ 113.88 3.7 $ 60.1 Unvested at June 30, 2020 10,000 $ 52.57 2.4 $ 0.7 Share-based compensation expense (benefit) recognized in connection with STAP awards is as follows (in millions): Three Months Ended Six Months Ended 2020 2019 2020 2019 Cost of product sales $ 1.5 $ (2.7 ) $ 2.2 $ (2.0 ) Research and development 8.7 (12.2 ) 10.9 (10.3 ) Selling, general, and administrative 26.5 (44.5 ) 33.7 (36.1 ) Share-based compensation expense (benefit) before taxes 36.7 (59.4 ) 46.8 (48.4 ) Related income tax (benefit) expense (6.8 ) 13.4 (9.1 ) 10.9 Share-based compensation expense (benefit), net of taxes $ 29.9 $ (46.0 ) $ 37.7 $ (37.5 ) Cash paid to settle STAP exercises during the six- month periods ended June 30, 2020 and June 30, 2019 was $10.8 million and $6.1 million , respectively. Employee Stock Purchase Plan In June 2012, our shareholders approved the ESPP, which is structured to comply with Section 423 of the Internal Revenue Code. 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. Offering periods, which began in 2012, occur in consecutive six-month periods commencing on September 5th and March 5th of each year. 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 has a 20 -year term and limits the aggregate number of shares that can be issued under the ESPP to 3.0 million . |
Earnings Per Common Share
Earnings Per Common Share | 6 Months Ended |
Jun. 30, 2020 | |
Earnings Per Share [Abstract] | |
Earnings Per Common Share | Earnings Per Common Share Basic earnings (loss) per common share is computed by dividing net income (loss) 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, restricted stock units, and shares issuable under the ESPP, as if they were vested and exercised. The components of basic and diluted earnings (loss) per common share comprised the following (in millions, except per share amounts): Three Months Ended Six Months Ended 2020 2019 2020 2019 Numerator: Net income (loss) $ 107.1 $ 205.1 $ 244.8 $ (289.5 ) Denominator: Weighted average outstanding shares — basic 44.1 43.8 44.0 43.8 Effect of dilutive securities (1) : Stock options, restricted stock units, and employee stock purchase plan 0.3 0.2 0.3 — Weighted average shares — diluted (2) 44.4 44.0 44.3 43.8 Net income (loss) per common share: Basic $ 2.43 $ 4.68 $ 5.56 $ (6.61 ) Diluted $ 2.41 $ 4.66 $ 5.53 $ (6.61 ) Stock options and restricted stock units excluded from calculation (2) 7.2 7.9 7.4 6.6 __________________________ (1) Calculated using the treasury stock method. (2) The common shares underlying certain stock options and restricted stock units have been excluded from the computation of diluted earnings per share because their impact would be anti-dilutive for the three- and six- month periods ended June 30, 2020 and the three-month period ended June 30, 2019 . For the six-month period ended June 30, 2019 , we had a net loss, and as such, all outstanding stock options, restricted stock units, and shares issuable under the ESPP were excluded from our calculation of diluted earnings per share. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Our effective income tax rate (ETR) for the six months ended June 30, 2020 and 2019 was 20 percent and 28 percent , respectively. For the six months ended June 30, 2020 , anticipated tax credits, state audit adjustments, and the foreign sales deduction, partially offset by non-deductible compensation and state tax expense, decreased our ETR. For the six months ended June 30, 2019 , anticipated tax credits, foreign sales deduction, and state tax benefit partially offset by non-deductible compensation and income tax benefit limitation, increased our ETR due to the pre-tax loss that resulted primarily from the $800.0 million upfront payment under our license agreement with Arena Pharmaceuticals, Inc. (Arena). As of June 30, 2020 and December 31, 2019, we had no unrecognized tax benefits. We record interest and penalties related to uncertain tax positions as a component of income tax expense. As of June 30, 2020 and December 31, 2019, we have not accrued any material interest expense related to uncertain tax positions. We are unaware of any material positions for which it is reasonably possible that the total amounts of unrecognized tax benefits will significantly increase within the next twelve months. On March 27, 2020, Congress enacted the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to provide certain relief as a result of the COVID-19 pandemic. The CARES Act, among other things, includes provisions relating to net operating loss carryback periods, alternative minimum tax credit refunds, and modification of the net interest deduction limitations. The CARES Act did not have a material impact on our consolidated financial statements for the six months ended June 30, 2020 . We continue to monitor any effects that may result from the CARES Act. |
Segment Information
Segment Information | 6 Months Ended |
Jun. 30, 2020 | |
Segment Reporting [Abstract] | |
Segment Information | Segment Information We currently 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. Net product sales, cost of product sales, and gross profit for each of our commercial products were as follows (in millions): Three Months Ended June 30, 2020 Remodulin Tyvaso Orenitram Unituxin Adcirca Total Net product sales $ 119.0 $ 119.2 $ 75.4 $ 29.0 $ 19.4 $ 362.0 Cost of product sales 5.3 4.6 3.9 3.9 8.2 25.9 Gross profit $ 113.7 $ 114.6 $ 71.5 $ 25.1 $ 11.2 $ 336.1 2019 Net product sales $ 155.8 $ 109.6 $ 54.0 $ 25.1 $ 29.1 $ 373.6 Cost of product sales 4.5 3.5 4.0 2.2 12.5 26.7 Gross profit $ 151.3 $ 106.1 $ 50.0 $ 22.9 $ 16.6 $ 346.9 Six Months Ended June 30, 2020 Remodulin Tyvaso Orenitram Unituxin Adcirca Total Net product sales $ 264.3 $ 222.1 $ 144.4 $ 55.6 $ 31.9 $ 718.3 Cost of product sales 11.3 9.7 8.6 6.2 13.5 49.3 Gross profit $ 253.0 $ 212.4 $ 135.8 $ 49.4 $ 18.4 $ 669.0 2019 Net product sales $ 311.3 $ 213.4 $ 112.4 $ 50.0 $ 49.1 $ 736.2 Cost of product sales 10.6 7.9 8.8 7.3 21.2 55.8 Gross profit $ 300.7 $ 205.5 $ 103.6 $ 42.7 $ 27.9 $ 680.4 Geographic revenues are determined based on the country in which our customers (distributors) are located. Total revenues from external customers by geographic area are as follows (in millions): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 United States $ 350.8 $ 339.5 $ 677.5 $ 669.0 Rest-of-World (1) 11.2 34.1 40.8 67.2 Total $ 362.0 $ 373.6 $ 718.3 $ 736.2 ______________________________ (1) Primarily Europe. We recorded revenue from two distributors in the United States that exceeded 10 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, 2020 2019 2020 2019 Distributor 1 55 % 54 % 55 % 56 % Distributor 2 29 % 22 % 27 % 21 % |
Litigation
Litigation | 6 Months Ended |
Jun. 30, 2020 | |
Litigation | |
Litigation | Litigation Sandoz Antitrust Litigation On April 16, 2019, Sandoz Inc. (Sandoz) and its commercialization collaborator, RareGen, LLC, 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 plaintiffs’ efforts to launch their generic version of Remodulin. In particular, the complaint alleges that we and Smiths Medical unlawfully impeded competition by entering into an agreement to produce CADD-MS ® 3 cartridges specifically for the delivery of subcutaneous Remodulin, without making these cartridges available for the delivery of Sandoz’s generic version of Remodulin. The parties completed expedited discovery in anticipation of a motion filed by the plaintiffs on October 4, 2019, seeking preliminary injunctive relief. We and Smiths Medical filed a motion to dismiss the complaint, and we filed our opposition to plaintiffs’ motion for a preliminary injunction on October 25, 2019. On January 29, 2020, the Court issued a decision denying the request for preliminary injunction sought by Sandoz and RareGen. According to the Court, “[Sandoz and RareGen] have not met their burden of demonstrating a reasonable probability of eventual success in the litigation.” The Court also denied our and Smiths Medical’s motion to dismiss the entire action. Plaintiffs declined to appeal the Court’s denial of their motion for preliminary injunction. The parties are currently engaged in discovery, and we do not anticipate a trial before mid-2021 at the earliest. On March 30, 2020, the plaintiffs filed an amended complaint in which Sandoz added a count alleging that we breached our earlier patent settlement agreement with Sandoz by refusing to grant Sandoz access to cartridges. We filed a motion to dismiss that count on April 17, 2020. We believe plaintiffs’ claims to be meritless and intend to vigorously defend the litigation. However, due to the uncertainty inherent in any litigation, we cannot guarantee that an adverse outcome will not result. Any litigation of this nature could involve substantial cost, and an adverse outcome could result in substantial monetary damages and/or injunctive relief adverse to our business. We currently are not able to reasonably estimate a range of potential losses due to the early stage of the litigation. Liquidia Technologies, Inc. On March 30, 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 seeks 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 our Remodulin, Tyvaso, and Orenitram products. 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 Remodulin, Tyvaso, and Orenitram. In mid-July, 2020 we filed preliminary responses to the petitions, and the PTAB has until mid-October to decide whether to institute IPR proceedings. If the PTAB institutes one or both reviews, the final written decision(s) will be due about a year after the PTAB’s decision to institute IPR proceedings, and following additional submissions by the parties. Any appeals of a PTAB decision would delay any final outcome. In January 2020, Liquidia submitted an NDA to the FDA for approval of LIQ861, a dry powder inhalation formulation of treprostinil. This NDA was submitted under the 505(b)(2) regulatory pathway with Tyvaso as the reference listed drug. On April 8, 2020, Liquidia announced that the FDA had accepted its NDA and set a Prescription Drug User Fee Act (PDUFA) target action date of November 24, 2020. In April 2020, we received a Paragraph IV Certification Notice Letter (Notice Letter) from Liquidia, stating that it intends to market LIQ861 before the expiration of all patents currently listed in the Orange Book for Tyvaso. The Notice Letter states that Liquidia’s NDA for LIQ861 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 LIQ861. On June 4, 2020, we filed a lawsuit in the U.S. District Court for the District of Delaware against Liquidia for infringement of the following patents relating to Tyvaso: U.S. Patent Nos. ’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 is automatically precluded from approving Liquidia’s NDA for up to 30 months or until the resolution of the litigation, whichever occurs first. On July 16, 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 LIQ861. On July 21, 2020, the USPTO issued a new patent relating to Tyvaso. The new patent, U.S. Patent No. 10,716,793, expires May 14, 2027, and is listed in the Orange Book for Tyvaso. On July 22, 2020, we filed an amended complaint against Liquidia to include a claim for infringement of this new patent. The new patent relates to a method of administering treprostinil via inhalation and it includes claims covering the dosing regimen used to administer Tyvaso. We plan to vigorously enforce our intellectual property rights related to Tyvaso. |
Arena License Agreement
Arena License Agreement | 6 Months Ended |
Jun. 30, 2020 | |
Arena License Agreement | |
Arena License Agreement | Arena License Agreement On November 15, 2018, we entered into an exclusive license agreement with Arena related to ralinepag, a next-generation, oral, selective, and potent prostacyclin receptor agonist being developed for the treatment of PAH. On January 24, 2019, in connection with the closing of the transactions contemplated by the license agreement: (1) Arena granted to us perpetual, irrevocable, and exclusive rights throughout the universe to develop, manufacture, and commercialize ralinepag; (2) Arena transferred to us certain other assets related to ralinepag, including, among others, related domain names and trademarks, permits, certain contracts, inventory, regulatory documentation, Investigational New Drug (IND) Application No. 109021 (related to ralinepag), and nonclinical, pre-clinical, and clinical trial data; (3) we assumed certain limited liabilities from Arena, including, among others, all obligations arising after the closing under the assumed contracts and the IND described above; and (4) we paid Arena an upfront payment of $800.0 million , which was expensed as acquired in-process research and development and included within research and development expenses on our consolidated statements of operations in the first quarter of 2019. We will also pay Arena: (1) a one-time payment of $250.0 million for the first, if any, marketing approval we receive in the United States for an inhaled version of ralinepag to treat PAH; (2) a one-time payment of $150.0 million for the first, if any, marketing approval we receive in any of Japan, France, Italy, the United Kingdom, Spain, or Germany for an oral version of ralinepag to treat any indication; and (3) low double-digit, tiered royalties on net sales of any pharmaceutical product containing ralinepag as an active ingredient, subject to certain adjustments for third party license payments. |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Basis of Presentation | |
Recently Issued Accounting Standards | Recently Issued Accounting Standards Accounting Standards Adopted During the Period In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (ASU 2016-13), which introduces new guidance for estimating credit losses on certain types of financial instruments based on expected losses and the timing of the recognition of such losses. ASU 2016-13 is effective for interim and annual reporting periods beginning after December 15, 2019. We adopted this standard on January 1, 2020 using the modified retrospective method for financial assets measured at amortized cost, including our net investment in a sales-type lease, financing receivables, and trade receivables. Upon adoption of the new standard, we recorded an allowance for credit losses of $1.1 million related to our net investment in a lease using an estimated default rate for the lessee over the lease term. The cumulative-effect adjustment resulted in a decrease to retained earnings of $0.8 million , which is net of a tax benefit. During the first quarter of 2020, we recognized an impairment charge of $1.5 million on a note receivable due to the expected loss from future payments as a result of economic uncertainty arising from the negative effects which the COVID-19 pandemic has had on the global economy and financial markets. We did not recognize any further impairment of this note receivable during the second quarter of 2020. We recorded this impairment charge within “other (expense) income, net” on our consolidated statements of operations. In January 2017, the FASB issued ASU No. 2017-04, Intangibles-Goodwill and Other: Simplifying the Test for Goodwill Impairment (ASU 2017-04), which simplifies how an entity is required to test goodwill for impairment. ASU 2017-04 requires that a goodwill impairment be measured by the amount by which a reporting unit’s carrying value exceeds its fair value, with the amount of impairment not to exceed the carrying amount of goodwill. ASU 2017-04 is effective for goodwill impairment tests in fiscal years beginning after December 15, 2019, and for interim periods within those fiscal years, and must be adopted on a prospective basis. We adopted the new standard on January 1, 2020, with no material impact on our financial statements. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement (ASU 2018-13), which eliminates, adds, and modifies certain disclosure requirements for fair value measurements. ASU 2018-13 is effective for interim and annual reporting periods beginning after December 15, 2019. We adopted the new standard on January 1, 2020, with no material impact on our financial statements. Accounting Standards Not Yet Adopted In August 2018, the FASB issued ASU No. 2018-14, Compensation-Retirement Benefits-Defined Benefit Plans-General (Topic 715-20): Disclosure Framework-Changes to the Disclosure Requirements for Defined Benefit Plans (ASU 2018-14). The standard modifies the disclosure requirements for employers that sponsor defined benefit pension or other postretirement plans. ASU 2018-14 is effective for fiscal years beginning after December 15, 2020. Early adoption is permitted. We do not expect the adoption of this guidance to have a material impact on our financial statements. In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes (ASU 2019-12) , which simplifies the accounting for income taxes by removing certain exceptions to the general principles of Topic 740, Income Taxes, and also improves consistency of application by clarifying and amending existing guidance. ASU 2019-12 is effective for fiscal years beginning after December 15, 2020, with early adoption permitted. We are currently evaluating the impact of this guidance on our financial statements. In January 2020, the FASB issued ASU 2020-01, Investments-Equity Securities (Topic 321), Investments-Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815)-Clarifying the Interactions between Topic 321, Topic 323, and Topic 815 (a consensus of the Emerging Issues Task Force) , which addresses the accounting for the transition into and out of the equity method and measuring certain purchased options and forward contracts to acquire investments. ASU 2020-01 is effective for fiscal years beginning after December 15, 2020, with early adoption permitted. We do not expect the adoption of this guidance to have a material impact on our financial statements. |
Investments (Tables)
Investments (Tables) - Available-for-Sale Debt Securities | 6 Months Ended |
Jun. 30, 2020 | |
Investments | |
Schedule of available-for-sale debt securities | Available-for-sale debt securities are recorded at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive income in stockholders’ equity, until realized. Available-for-sale debt securities consisted of the following (in millions): As of June 30, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. government and agency securities $ 1,567.9 $ 14.6 $ (0.1 ) $ 1,582.4 Corporate debt securities 265.9 4.5 — 270.4 Total $ 1,833.8 $ 19.1 $ (0.1 ) $ 1,852.8 Reported under the following captions on our consolidated balance sheets: Current marketable investments 843.4 Non-current marketable investments 1,009.4 Total $ 1,852.8 As of December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. government and agency securities $ 1,225.2 $ 2.9 $ (0.2 ) $ 1,227.9 Corporate debt securities 222.4 1.7 — 224.1 Total $ 1,447.6 $ 4.6 $ (0.2 ) $ 1,452.0 Reported under the following captions on our consolidated balance sheets: Current marketable investments 684.5 Non-current marketable investments 767.5 Total $ 1,452.0 |
Summary of the contractual maturities | The following table summarizes the contractual maturities of available-for-sale marketable investments (in millions): As of June 30, 2020 Amortized Cost Fair Value Due within one year $ 838.6 $ 843.4 Due in one to three years 995.2 1,009.4 Total $ 1,833.8 $ 1,852.8 As of December 31, 2019 Amortized Cost Fair Value Due within one year $ 683.3 $ 684.5 Due in one to three years 764.3 767.5 Total $ 1,447.6 $ 1,452.0 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
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, 2020 Level 1 Level 2 Level 3 Balance Assets Money market funds (1) $ 215.1 $ — $ — $ 215.1 Time deposits (2) — 88.0 — 88.0 U.S. government and agency securities (3) — 1,582.3 — 1,582.3 Corporate debt securities (3) — 270.5 — 270.5 Equity securities (4) 32.0 — — 32.0 Total assets $ 247.1 $ 1,940.8 $ — $ 2,187.9 Liabilities Contingent consideration (5) — — 13.6 13.6 Total liabilities $ — $ — $ 13.6 $ 13.6 As of December 31, 2019 Level 1 Level 2 Level 3 Balance Assets Money market funds (1) $ 270.0 $ — $ — $ 270.0 Time deposits (2) — 87.3 — 87.3 U.S. government and agency securities (3) — 1,227.9 — 1,227.9 Corporate debt securities (3) — 224.1 — 224.1 Equity securities (4) 63.0 — — 63.0 Total assets $ 333.0 $ 1,539.3 $ — $ 1,872.3 Liabilities Contingent consideration (5) — — 13.4 13.4 Total liabilities $ — $ — $ 13.4 $ 13.4 ________________________ (1) Included in cash and cash equivalents on our consolidated balance sheets. (2) Included in cash and cash equivalents and current marketable investments on our consolidated balance sheets. The fair value of these securities is principally measured or corroborated by trade data for identical securities in 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 cash and cash equivalents and current and non-current marketable investments on our consolidated balance sheets. Refer to Note 3 —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. (4) Included in current marketable investments on 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, 2020 , we recognized $8.9 million and $15.0 million of net unrealized and realized losses on these securities. During the three and six months ended June 30, 2019 , we recognized $29.5 million and $32.5 million of net unrealized gains on these securities. We recorded these gains and losses on our consolidated statements of operations within “other (expense) income, net”. Refer to Note 3 —Investments—Investments in Equity Securities with Readily Determinable Fair Values. (5) Included in non-current liabilities on 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 change in the fair value of our contingent consideration obligations for the three and six months ended June 30, 2020 was not material. |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
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, December 31, Raw materials $ 18.9 $ 21.1 Work-in-progress 27.9 29.1 Finished goods 42.9 43.2 Total inventories $ 89.7 $ 93.4 |
Goodwill and Other Intangible_2
Goodwill and Other Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of goodwill and other intangible assets | Goodwill and other intangible assets comprise the following (in millions): As of June 30, 2020 As of December 31, 2019 Gross Accumulated Amortization Net Gross Accumulated Amortization Net Goodwill $ 28.0 $ — $ 28.0 $ 28.0 $ — $ 28.0 Other intangible assets: Technology, patents, and trade names 6.7 (5.4 ) 1.3 6.7 (5.3 ) 1.4 In-process research and development (1) 128.9 — 128.9 128.9 — 128.9 Total $ 163.6 $ (5.4 ) $ 158.2 $ 163.6 $ (5.3 ) $ 158.3 (1) In April 2020, the FDA issued a complete response letter related to our Trevyent ® new drug application (NDA) indicating that some of the deficiencies previously raised by the FDA had not yet been addressed to its satisfaction. We determined this to be a potential indicator of impairment of our in-process research and development (IPR&D) asset related to Trevyent, which had a carrying value of $107.3 million as of June 30, 2020 . We obtained a third-party valuation of the IPR&D asset to estimate its fair value using the income approach, together with Level 3 valuation inputs, including estimated future cash flows and a discount rate. Significant judgment is required to determine the probability of success of a drug candidate as well as the associated revenue from a future product launch. Based on this valuation, the fair value was in excess of carrying value; therefore, the IPR&D asset was no |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Stock options | |
Share-Based Compensation | |
Schedule of components of share-based compensation expense recognized | The following table reflects the components of share-based compensation expense (benefit) recognized in our consolidated statements of operations (in millions): Three Months Ended Six Months Ended 2020 2019 2020 2019 Stock options $ 9.2 $ 18.1 $ 25.6 $ 33.8 Restricted stock units 5.5 3.8 9.5 6.0 STAP awards 36.7 (59.4 ) 46.8 (48.4 ) Employee stock purchase plan 0.4 0.3 0.7 0.6 Total share-based compensation expense (benefit) before tax $ 51.8 $ (37.2 ) $ 82.6 $ (8.0 ) |
Summary 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, 2020 and June 30, 2019 : June 30, June 30, Expected term of awards (in years) 5.6 5.8 Expected volatility 33.4 % 33.8 % Risk-free interest rate 0.5 % 2.4 % 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, 2020 is presented below: Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in Years) Aggregate Outstanding at January 1, 2020 8,088,680 $ 123.34 Granted 57,879 111.77 Exercised (346,549 ) 64.54 Forfeited/canceled (8,779 ) 135.48 Outstanding at June 30, 2020 7,791,231 $ 125.86 6.0 $ 33.8 Exercisable at June 30, 2020 4,974,974 $ 127.46 5.5 $ 23.3 Unvested at June 30, 2020 2,816,257 $ 123.04 7.0 $ 10.5 |
Schedule of share-based compensation expense (benefit) recognized | Total share-based compensation expense relating to stock options is recorded as follows (in millions): Three Months Ended Six Months Ended 2020 2019 2020 2019 Cost of product sales $ 0.1 $ 0.2 $ 0.3 $ 0.4 Research and development 0.4 0.9 1.3 1.8 Selling, general, and administrative 8.7 17.0 24.0 31.6 Share-based compensation expense before taxes 9.2 18.1 25.6 33.8 Related income tax expense (benefit) 1.4 (4.1 ) (2.3 ) (7.6 ) Share-based compensation expense, net of taxes $ 10.6 $ 14.0 $ 23.3 $ 26.2 |
Summary of stock option exercise data | Stock option exercise data is summarized below (dollars in millions): Three Months Ended Six Months Ended 2020 2019 2020 2019 Number of options exercised 333,049 25,000 346,549 191,508 Cash received $ 21.7 $ 1.1 $ 22.4 $ 9.9 Total intrinsic value of options exercised $ 18.1 $ 1.2 $ 18.7 $ 11.5 |
Restricted stock units | |
Share-Based Compensation | |
Schedule of share-based compensation expense (benefit) recognized | Total share-based compensation expense relating to restricted stock units is recorded as follows (in millions): Three Months Ended Six Months Ended 2020 2019 2020 2019 Cost of product sales $ 0.4 $ 0.3 $ 0.7 $ 0.5 Research and development 2.1 1.2 3.5 1.9 Selling, general, and administrative 3.0 2.3 5.3 3.6 Share-based compensation expense before taxes 5.5 3.8 9.5 6.0 Related income tax benefit (1.3 ) (0.9 ) (2.2 ) (1.4 ) Share-based compensation expense, net of taxes $ 4.2 $ 2.9 $ 7.3 $ 4.6 |
Schedule of restricted stock units activity | A summary of the activity with respect to, and status of, restricted stock units during the six- month period ended June 30, 2020 is presented below: Number of Restricted Stock Units Weighted Average Grant Date Fair Value Weighted Average Remaining Contractual Term (in Years) Aggregate Unvested at January 1, 2020 310,725 $ 112.24 Granted 277,379 94.16 Vested (127,167 ) 108.63 Forfeited/canceled (7,080 ) 107.53 Unvested at June 30, 2020 453,857 $ 102.28 9.2 $ 54.9 |
STAP awards | |
Share-Based Compensation | |
Schedule of share-based compensation expense (benefit) recognized | Share-based compensation expense (benefit) recognized in connection with STAP awards is as follows (in millions): Three Months Ended Six Months Ended 2020 2019 2020 2019 Cost of product sales $ 1.5 $ (2.7 ) $ 2.2 $ (2.0 ) Research and development 8.7 (12.2 ) 10.9 (10.3 ) Selling, general, and administrative 26.5 (44.5 ) 33.7 (36.1 ) Share-based compensation expense (benefit) before taxes 36.7 (59.4 ) 46.8 (48.4 ) Related income tax (benefit) expense (6.8 ) 13.4 (9.1 ) 10.9 Share-based compensation expense (benefit), net of taxes $ 29.9 $ (46.0 ) $ 37.7 $ (37.5 ) |
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, June 30, Expected term of awards (in years) 1.9 2.3 Expected volatility 32.1 % 28.9 % Risk-free interest rate 0.2 % 1.7 % Expected dividend yield — % — % |
Summary 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, 2020 is presented below: Number of Awards Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in Years) Aggregate Intrinsic Value (in millions) Outstanding at January 1, 2020 2,622,328 $ 109.10 Granted — — Exercised (239,312 ) 63.40 Forfeited/canceled (17,054 ) 123.11 Outstanding at June 30, 2020 2,365,962 $ 113.62 3.7 $ 60.8 Exercisable at June 30, 2020 2,355,962 $ 113.88 3.7 $ 60.1 Unvested at June 30, 2020 10,000 $ 52.57 2.4 $ 0.7 |
Earnings Per Common Share (Tabl
Earnings Per Common Share (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Earnings Per Common Share | |
Schedule of components of basic and diluted earnings (loss) per common share | The components of basic and diluted earnings (loss) per common share comprised the following (in millions, except per share amounts): Three Months Ended Six Months Ended 2020 2019 2020 2019 Numerator: Net income (loss) $ 107.1 $ 205.1 $ 244.8 $ (289.5 ) Denominator: Weighted average outstanding shares — basic 44.1 43.8 44.0 43.8 Effect of dilutive securities (1) : Stock options, restricted stock units, and employee stock purchase plan 0.3 0.2 0.3 — Weighted average shares — diluted (2) 44.4 44.0 44.3 43.8 Net income (loss) per common share: Basic $ 2.43 $ 4.68 $ 5.56 $ (6.61 ) Diluted $ 2.41 $ 4.66 $ 5.53 $ (6.61 ) Stock options and restricted stock units excluded from calculation (2) 7.2 7.9 7.4 6.6 __________________________ (1) Calculated using the treasury stock method. (2) The common shares underlying certain stock options and restricted stock units have been excluded from the computation of diluted earnings per share because their impact would be anti-dilutive for the three- and six- month periods ended June 30, 2020 and the three-month period ended June 30, 2019 . For the six-month period ended June 30, 2019 , we had a net loss, and as such, all outstanding stock options, restricted stock units, and shares issuable under the ESPP were excluded from our calculation of diluted earnings per share. |
Segment Information (Tables)
Segment Information (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Segment Reporting [Abstract] | |
Schedule of net product sales, cost of product sales and gross profit for each commercial products | Net product sales, cost of product sales, and gross profit for each of our commercial products were as follows (in millions): Three Months Ended June 30, 2020 Remodulin Tyvaso Orenitram Unituxin Adcirca Total Net product sales $ 119.0 $ 119.2 $ 75.4 $ 29.0 $ 19.4 $ 362.0 Cost of product sales 5.3 4.6 3.9 3.9 8.2 25.9 Gross profit $ 113.7 $ 114.6 $ 71.5 $ 25.1 $ 11.2 $ 336.1 2019 Net product sales $ 155.8 $ 109.6 $ 54.0 $ 25.1 $ 29.1 $ 373.6 Cost of product sales 4.5 3.5 4.0 2.2 12.5 26.7 Gross profit $ 151.3 $ 106.1 $ 50.0 $ 22.9 $ 16.6 $ 346.9 Six Months Ended June 30, 2020 Remodulin Tyvaso Orenitram Unituxin Adcirca Total Net product sales $ 264.3 $ 222.1 $ 144.4 $ 55.6 $ 31.9 $ 718.3 Cost of product sales 11.3 9.7 8.6 6.2 13.5 49.3 Gross profit $ 253.0 $ 212.4 $ 135.8 $ 49.4 $ 18.4 $ 669.0 2019 Net product sales $ 311.3 $ 213.4 $ 112.4 $ 50.0 $ 49.1 $ 736.2 Cost of product sales 10.6 7.9 8.8 7.3 21.2 55.8 Gross profit $ 300.7 $ 205.5 $ 103.6 $ 42.7 $ 27.9 $ 680.4 |
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 by geographic area are as follows (in millions): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 United States $ 350.8 $ 339.5 $ 677.5 $ 669.0 Rest-of-World (1) 11.2 34.1 40.8 67.2 Total $ 362.0 $ 373.6 $ 718.3 $ 736.2 ______________________________ (1) Primarily Europe. |
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 10 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, 2020 2019 2020 2019 Distributor 1 55 % 54 % 55 % 56 % Distributor 2 29 % 22 % 27 % 21 % |
Basis of Presentation - Recentl
Basis of Presentation - Recently Issued Accounting Standards (Details) - USD ($) $ in Millions | Jan. 01, 2020 | Mar. 31, 2020 | Jun. 30, 2020 | Dec. 31, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 |
Recently Issued Accounting Standards | |||||||
Decrease to retained earnings | $ (2,948.5) | $ (3,093.7) | $ (2,780.4) | $ (2,558.4) | $ (2,319) | $ (2,788.6) | |
ASU 2016-13 | |||||||
Recently Issued Accounting Standards | |||||||
Allowance for credit losses | $ 1.1 | ||||||
Impairment charges | $ 1.5 | ||||||
Cumulative Effect, Period of Adoption, Adjustment | |||||||
Recently Issued Accounting Standards | |||||||
Decrease to retained earnings | 0.8 | $ 5.1 | |||||
Cumulative Effect, Period of Adoption, Adjustment | ASU 2016-13 | |||||||
Recently Issued Accounting Standards | |||||||
Decrease to retained earnings | $ 0.8 |
Investments - Available-for-Sal
Investments - Available-for-Sale Debt Securities (Details) - USD ($) $ in Millions | Jun. 30, 2020 | Dec. 31, 2019 |
Marketable investments classified as available-for-sale debt securities: | ||
Amortized Cost | $ 1,833.8 | $ 1,447.6 |
Gross Unrealized Gains | 19.1 | 4.6 |
Gross Unrealized Losses | (0.1) | (0.2) |
Fair Value | 1,852.8 | 1,452 |
U.S. government and agency securities | ||
Marketable investments classified as available-for-sale debt securities: | ||
Amortized Cost | 1,567.9 | 1,225.2 |
Gross Unrealized Gains | 14.6 | 2.9 |
Gross Unrealized Losses | (0.1) | (0.2) |
Fair Value | 1,582.4 | 1,227.9 |
Corporate debt securities | ||
Marketable investments classified as available-for-sale debt securities: | ||
Amortized Cost | 265.9 | 222.4 |
Gross Unrealized Gains | 4.5 | 1.7 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $ 270.4 | $ 224.1 |
Investments - Current and Non-c
Investments - Current and Non-current of Available-for-Sale Debt Securities (Details) - USD ($) $ in Millions | Jun. 30, 2020 | Dec. 31, 2019 |
Reported under the following captions on our consolidated balance sheet: | ||
Total | $ 1,852.8 | $ 1,452 |
Current marketable investments | ||
Reported under the following captions on our consolidated balance sheet: | ||
Total | 843.4 | 684.5 |
Non-current marketable investments | ||
Reported under the following captions on our consolidated balance sheet: | ||
Total | $ 1,009.4 | $ 767.5 |
Investments - Contractual Matur
Investments - Contractual Maturities of Available-for-Sale Marketable Investments (Details) - USD ($) $ in Millions | Jun. 30, 2020 | Dec. 31, 2019 |
Amortized Cost | ||
Due within one year | $ 838.6 | $ 683.3 |
Due in one to three years | 995.2 | 764.3 |
Total | 1,833.8 | 1,447.6 |
Fair Value | ||
Due within one year | 843.4 | 684.5 |
Due in one to three years | 1,009.4 | 767.5 |
Total | $ 1,852.8 | $ 1,452 |
Investments - Investments in Eq
Investments - Investments in Equity Securities with Readily Determinable Fair Values (Details) - USD ($) $ in Millions | Jun. 30, 2020 | Dec. 31, 2019 |
Equity securities | ||
Investments in Equity Securities with Readily Determinable Fair Values | ||
Investments in equity securities with readily determinable fair value | $ 32 | $ 63 |
Investments - Investments in Pr
Investments - Investments in Privately-Held Companies (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Investments in Privately-Held Companies and Investments in Equity Securities with Readily Determinable Fair Values | ||||||
Impairments of investments in privately-held companies | $ 0 | $ 5.6 | $ 0 | $ 5.6 | $ 0 | |
Privately-held Companies | ||||||
Investments in Privately-Held Companies and Investments in Equity Securities with Readily Determinable Fair Values | ||||||
Investments in privately-held companies | $ 102.9 | $ 102.9 | $ 86 | |||
Increase in the value of investment | $ 22.5 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring fair value measurements - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Equity securities | Other income (expense), net | |||||
Liabilities | |||||
Net unrealized and realized (losses) gains on securities | $ (8.9) | $ 29.5 | $ (15) | $ 32.5 | |
Level 1 | |||||
Assets | |||||
Total assets | 247.1 | 247.1 | $ 333 | ||
Liabilities | |||||
Contingent consideration | 0 | 0 | 0 | ||
Total liabilities | 0 | 0 | 0 | ||
Level 1 | Money market funds | |||||
Assets | |||||
Total assets | 215.1 | 215.1 | 270 | ||
Level 1 | Time deposits | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Level 1 | U.S. government and agency securities | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Level 1 | Corporate debt securities | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Level 1 | Equity securities | |||||
Assets | |||||
Total assets | 32 | 32 | 63 | ||
Level 2 | |||||
Assets | |||||
Total assets | 1,940.8 | 1,940.8 | 1,539.3 | ||
Liabilities | |||||
Contingent consideration | 0 | 0 | 0 | ||
Total liabilities | 0 | 0 | 0 | ||
Level 2 | Money market funds | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Level 2 | Time deposits | |||||
Assets | |||||
Total assets | 88 | 88 | 87.3 | ||
Level 2 | U.S. government and agency securities | |||||
Assets | |||||
Total assets | 1,582.3 | 1,582.3 | 1,227.9 | ||
Level 2 | Corporate debt securities | |||||
Assets | |||||
Total assets | 270.5 | 270.5 | 224.1 | ||
Level 2 | Equity securities | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Level 3 | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Liabilities | |||||
Contingent consideration | 13.6 | 13.6 | 13.4 | ||
Total liabilities | 13.6 | 13.6 | 13.4 | ||
Level 3 | Money market funds | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Level 3 | Time deposits | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Level 3 | U.S. government and agency securities | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Level 3 | Corporate debt securities | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Level 3 | Equity securities | |||||
Assets | |||||
Total assets | 0 | 0 | 0 | ||
Balance | |||||
Assets | |||||
Total assets | 2,187.9 | 2,187.9 | 1,872.3 | ||
Liabilities | |||||
Contingent consideration | 13.6 | 13.6 | 13.4 | ||
Total liabilities | 13.6 | 13.6 | 13.4 | ||
Balance | Money market funds | |||||
Assets | |||||
Total assets | 215.1 | 215.1 | 270 | ||
Balance | Time deposits | |||||
Assets | |||||
Total assets | 88 | 88 | 87.3 | ||
Balance | U.S. government and agency securities | |||||
Assets | |||||
Total assets | 1,582.3 | 1,582.3 | 1,227.9 | ||
Balance | Corporate debt securities | |||||
Assets | |||||
Total assets | 270.5 | 270.5 | 224.1 | ||
Balance | Equity securities | |||||
Assets | |||||
Total assets | $ 32 | $ 32 | $ 63 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Millions | Jun. 30, 2020 | Dec. 31, 2019 |
Inventories | ||
Raw materials | $ 18.9 | $ 21.1 |
Work-in-progress | 27.9 | 29.1 |
Finished goods | 42.9 | 43.2 |
Total inventories | $ 89.7 | $ 93.4 |
Goodwill and Other Intangible_3
Goodwill and Other Intangible Assets (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2020 | Dec. 31, 2019 | |
Goodwill and Other Intangible Assets | ||
Goodwill, gross | $ 28,000,000 | $ 28,000,000 |
Goodwill, net | 28,000,000 | 28,000,000 |
Finite-Lived Intangible Assets, Net | ||
Other intangible assets, accumulated amortization | (5,400,000) | (5,300,000) |
Intangible Assets, Net (Including Goodwill) | ||
Total goodwill and other intangible assets, gross | 163,600,000 | 163,600,000 |
Total goodwill and other intangible assets, net | 158,200,000 | 158,300,000 |
Technology, patents, and trade names | ||
Finite-Lived Intangible Assets, Net | ||
Other intangible assets, gross | 6,700,000 | 6,700,000 |
Other intangible assets, accumulated amortization | (5,400,000) | (5,300,000) |
Other intangible assets, net | 1,300,000 | 1,400,000 |
In-process research and development | ||
Finite-Lived Intangible Assets, Net | ||
Other intangible assets, gross | 128,900,000 | 128,900,000 |
Other intangible assets, accumulated amortization | 0 | 0 |
Other intangible assets, net | 128,900,000 | $ 128,900,000 |
Intangible Assets, Net (Including Goodwill) | ||
Carrying value of Trevyent intangible asset | 107,300,000 | |
Finite-lived intangible asset impairment | $ 0 |
Debt (Details)
Debt (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Debt | |||||||
Line of credit (current) | $ 0 | $ 0 | $ 250,000,000 | ||||
Credit Agreement | |||||||
Debt | |||||||
Debt, maturity term | 1 year | ||||||
Outstanding aggregate principal balance | $ 850,000,000 | ||||||
Repayment term | 1 year | 1 year | |||||
Line of credit repaid during the period | $ 50,000,000 | ||||||
Interest expense | 5,600,000 | $ 12,200,000 | 13,700,000 | $ 22,500,000 | |||
Credit Agreement | Current liabilities | |||||||
Debt | |||||||
Line of credit (current) | $ 250,000,000 | ||||||
Credit Agreement | Non-current liabilities | |||||||
Debt | |||||||
Outstanding aggregate principal balance | $ 800,000,000 | 800,000,000 | |||||
First unsecured revolving credit facility | |||||||
Debt | |||||||
Borrowing | $ 1,000,000,000 | ||||||
Second unsecured revolving credit facility | |||||||
Debt | |||||||
Borrowing | 500,000,000 | ||||||
Increase in borrowing capacity | $ 300,000,000 | ||||||
2018 Credit Agreement | Other current assets | |||||||
Debt | |||||||
Debt issuance costs capitalized | 3,400,000 | ||||||
2018 Credit Agreement | Other non-current assets | |||||||
Debt | |||||||
Debt issuance costs capitalized | $ 7,900,000 |
Share-Based Compensation - Gene
Share-Based Compensation - General (Details) | 1 Months Ended | 6 Months Ended |
Feb. 28, 2019shares | Jun. 30, 2020planshares | |
Share-Based Compensation | ||
Number of equity incentive plans | plan | 2 | |
2015 Plan | ||
Share-Based Compensation | ||
Maximum number of shares authorized to be issued | 10,000,000 | |
Additional number of shares authorized to be issued | 500,000 | |
2019 Inducement Plan | Newly-hired employees | ||
Share-Based Compensation | ||
Number of equity incentive plans | plan | 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 by Plan (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Share-Based Compensation | ||||
Total share-based compensation expense (benefit) before tax | $ 51.8 | $ (37.2) | $ 82.6 | $ (8) |
Stock options | ||||
Share-Based Compensation | ||||
Total share-based compensation expense (benefit) before tax | 9.2 | 18.1 | 25.6 | 33.8 |
Restricted stock units | ||||
Share-Based Compensation | ||||
Total share-based compensation expense (benefit) before tax | 5.5 | 3.8 | 9.5 | 6 |
STAP awards | ||||
Share-Based Compensation | ||||
Total share-based compensation expense (benefit) before tax | 36.7 | (59.4) | 46.8 | (48.4) |
Employee stock purchase plan | ||||
Share-Based Compensation | ||||
Total share-based compensation expense (benefit) before tax | $ 0.4 | $ 0.3 | $ 0.7 | $ 0.6 |
Share-Based Compensation - Assu
Share-Based Compensation - Assumptions For Stock Options (Details) - Stock options | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Method and assumptions on valuation of stock options | ||
Expected term of awards (in years) | 5 years 7 months 6 days | 5 years 9 months 18 days |
Expected volatility | 33.40% | 33.80% |
Risk-free interest rate | 0.50% | 2.40% |
Expected dividend yield | 0.00% | 0.00% |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock and Status (Details) - Stock options - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Options | ||||
Outstanding at beginning of the period (in shares) | 8,088,680 | |||
Granted (in shares) | 57,879 | |||
Exercised (in shares) | (333,049) | (25,000) | (346,549) | (191,508) |
Forfeited/canceled (in shares) | (8,779) | |||
Outstanding at the end of the period (in shares) | 7,791,231 | 7,791,231 | ||
Exercisable at the end of the period (in shares) | 4,974,974 | 4,974,974 | ||
Unvested at the end of the period (in shares) | 2,816,257 | 2,816,257 | ||
Weighted Average Exercise Price | ||||
Outstanding at beginning of the period (in dollars per share) | $ 123.34 | |||
Granted (in dollars per share) | 111.77 | |||
Exercised (in dollars per share) | 64.54 | |||
Forfeited (in dollars per share) | 135.48 | |||
Outstanding at the end of the period (in dollars per share) | $ 125.86 | 125.86 | ||
Exercisable at the end of the period (in dollars per share) | 127.46 | 127.46 | ||
Unvested at the end of the period (in dollars per share) | $ 123.04 | $ 123.04 | ||
Weighted Average Remaining Contractual Term (in Years) | ||||
Outstanding at the end of the period (in Years) | 6 years | |||
Exercisable at the end of the period (in Years) | 5 years 6 months | |||
Unvested at the end of the period (in Years) | 7 years | |||
Aggregate Intrinsic Value | ||||
Outstanding at the end of the period | $ 23.3 | $ 23.3 | ||
Exercisable at the end of the period | 33.8 | 33.8 | ||
Unvested at the end of the period | $ 10.5 | $ 10.5 | ||
Weighted average grant date fair value of stock options (in dollars per share) | $ 35.53 | $ 39.63 | ||
Aggregate grant date fair value | $ 2.1 | $ 82.5 | ||
Total grant date fair value of employee stock options that vested | $ 72.7 | $ 36.3 |
Share-Based Compensation - Shar
Share-Based Compensation - Share-Based Compensation Expense (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Share-based compensation expense | ||||
Share-based compensation expense before taxes | $ 51.8 | $ (37.2) | $ 82.6 | $ (8) |
Stock options | ||||
Share-based compensation expense | ||||
Share-based compensation expense before taxes | 9.2 | 18.1 | 25.6 | 33.8 |
Related income tax expense (benefit) | 1.4 | (4.1) | (2.3) | (7.6) |
Share-based compensation expense, net of taxes | 10.6 | 14 | 23.3 | 26.2 |
Unrecognized compensation cost | 66.4 | $ 66.4 | ||
Weighted average remaining vesting period | 2 years 4 months 24 days | |||
Restricted stock units | ||||
Share-based compensation expense | ||||
Share-based compensation expense before taxes | 5.5 | 3.8 | $ 9.5 | 6 |
Related income tax expense (benefit) | (1.3) | (0.9) | (2.2) | (1.4) |
Share-based compensation expense, net of taxes | 4.2 | 2.9 | 7.3 | 4.6 |
Unrecognized compensation cost | 40 | $ 40 | ||
Weighted average remaining vesting period | 2 years 1 month 6 days | |||
Cost of product sales | Stock options | ||||
Share-based compensation expense | ||||
Share-based compensation expense before taxes | 0.1 | 0.2 | $ 0.3 | 0.4 |
Cost of product sales | Restricted stock units | ||||
Share-based compensation expense | ||||
Share-based compensation expense before taxes | 0.4 | 0.3 | 0.7 | 0.5 |
Research and development | Stock options | ||||
Share-based compensation expense | ||||
Share-based compensation expense before taxes | 0.4 | 0.9 | 1.3 | 1.8 |
Research and development | Restricted stock units | ||||
Share-based compensation expense | ||||
Share-based compensation expense before taxes | 2.1 | 1.2 | 3.5 | 1.9 |
Selling, general, and administrative | Stock options | ||||
Share-based compensation expense | ||||
Share-based compensation expense before taxes | 8.7 | 17 | 24 | 31.6 |
Selling, general, and administrative | Restricted stock units | ||||
Share-based compensation expense | ||||
Share-based compensation expense before taxes | $ 3 | $ 2.3 | $ 5.3 | $ 3.6 |
Share-Based Compensation - St_2
Share-Based Compensation - Stock Options Exercise Data (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Summary of stock option exercise data | ||||
Cash received | $ 22.4 | $ 9.9 | ||
Stock options | ||||
Summary of stock option exercise data | ||||
Number of options exercised | 333,049 | 25,000 | 346,549 | 191,508 |
Cash received | $ 21.7 | $ 1.1 | $ 22.4 | $ 9.9 |
Total intrinsic value of options exercised | $ 18.1 | $ 1.2 | $ 18.7 | $ 11.5 |
Share-Based Compensation - Rest
Share-Based Compensation - Restricted Stock Options Activity and Status (Details) - Restricted stock units $ / shares in Units, $ in Millions | 6 Months Ended |
Jun. 30, 2020USD ($)$ / sharesshares | |
Share-Based Compensation | |
Number of shares of common stock entitled to recipient upon vesting | 1 |
Number of Restricted Stock Units | |
Unvested at beginning of the period (in shares) | 310,725 |
Granted (in shares) | 277,379 |
Vested (in shares) | (127,167) |
Forfeited/cancelled (in shares) | (7,080) |
Unvested at the end of the period (in shares) | 453,857 |
Weighted Average Grant Date Fair Value | |
Unvested at beginning of the period (in dollars per share) | $ / shares | $ 112.24 |
Granted (in dollars per share) | $ / shares | 94.16 |
Vested (in dollars per share) | $ / shares | 108.63 |
Forfeited/cancelled (in dollars per share) | $ / shares | 107.53 |
Unvested at the end of the period (in dollars per share) | $ / shares | $ 102.28 |
Weighted Average Remaining Contractual Term (in Years) | |
Outstanding at end of the period | 9 years 2 months 12 days |
Aggregate Intrinsic Value (in millions) | |
Unvested at the end of the period (in dollars) | $ | $ 54.9 |
Share-Based Compensation - STAP
Share-Based Compensation - STAP awards (Details) - STAP awards - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Awards granted | |||
Grant expiration period from the grant date | 4 years | ||
Aggregate STAP liability | $ 61 | $ 25 | |
Weighted-average assumptions used to measure the fair value of the outstanding STAP awards: | |||
Expected term of awards (in years) | 1 year 10 months 24 days | 2 years 3 months 18 days | |
Expected volatility | 32.10% | 28.90% | |
Risk-free interest rate (as a percent) | 0.20% | 1.70% | |
Expected dividend yield | 0.00% | 0.00% | |
Closing price of common stock (in dollars per share) | $ 121 | $ 78.06 | $ 88.08 |
Number of Awards | |||
Outstanding at beginning of period (in shares) | 2,622,328 | ||
Granted (in shares) | 0 | ||
Exercised (in shares) | (239,312) | ||
Forfeited/cancelled (in shares) | (17,054) | ||
Outstanding at end of period (in shares) | 2,365,962 | ||
Exercisable at end of period (in shares) | 2,355,962 | ||
Unvested at end of period (in shares) | 10,000 | ||
Weighted Average Grant Date Fair Value | |||
Outstanding at beginning of period (in dollars per share) | $ 109.10 | ||
Granted (in dollars per share) | 0 | ||
Exercised (in dollars per share) | 63.40 | ||
Forfeited (in dollars per share) | 123.11 | ||
Outstanding at end of period (in dollars per share) | 113.62 | ||
Exercisable at end of period (in dollars per share) | 113.88 | ||
Unvested at end of period (in dollars per share) | $ 52.57 | ||
Weighted Average Remaining Contractual Term (in Years) | |||
Outstanding at end of the period | 3 years 8 months 12 days | ||
Exercisable at end of period | 3 years 8 months 12 days | ||
Unvested at end of period | 2 years 4 months 24 days | ||
Aggregate Intrinsic Value (in millions) | |||
Outstanding at end of period | $ 60.8 | ||
Exercisable at end of period | 60.1 | ||
Unvested at end of period | $ 0.7 |
Share-Based Compensation - Sh_2
Share-Based Compensation - Share Tracking Awards Plans - Benefit recognized (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Share based compensation (benefit) expense recognized in connection with the STAP | ||||
Share-based compensation expense before taxes | $ 51.8 | $ (37.2) | $ 82.6 | $ (8) |
STAP awards | ||||
Share based compensation (benefit) expense recognized in connection with the STAP | ||||
Share-based compensation expense before taxes | 36.7 | (59.4) | 46.8 | (48.4) |
Related income tax (benefit) expense | (6.8) | 13.4 | (9.1) | 10.9 |
Share-based compensation expense, net of taxes | 29.9 | (46) | 37.7 | (37.5) |
Cash payments on awards exercised during the period | 10.8 | 6.1 | ||
Cost of product sales | STAP awards | ||||
Share based compensation (benefit) expense recognized in connection with the STAP | ||||
Share-based compensation expense before taxes | 1.5 | (2.7) | 2.2 | (2) |
Research and development | STAP awards | ||||
Share based compensation (benefit) expense recognized in connection with the STAP | ||||
Share-based compensation expense before taxes | 8.7 | (12.2) | 10.9 | (10.3) |
Selling, general, and administrative | STAP awards | ||||
Share based compensation (benefit) expense recognized in connection with the STAP | ||||
Share-based compensation expense before taxes | $ 26.5 | $ (44.5) | $ 33.7 | $ (36.1) |
Share-Based Compensation - Empl
Share-Based Compensation - Employee Stock Purchase Plan (Details) - Employee stock purchase plan | 1 Months Ended |
Jun. 30, 2012shares | |
Share-based compensation expense | |
Maximum percentage of compensation employees may contribute for ESPP | 15.00% |
Percentage of the lower of the fair market value of common stock on the first or last trading day of a given offering period | 85.00% |
Maximum number of shares each eligible employees may purchase in any given offering period (in shares) | 4,000 |
Term of ESPP | 20 years |
Maximum number of shares authorized to be issued (in shares) | 3,000,000 |
Earnings Per Common Share (Deta
Earnings Per Common Share (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Numerator: | ||||
Net income (loss) | $ 107.1 | $ 205.1 | $ 244.8 | $ (289.5) |
Denominator: | ||||
Weighted average outstanding shares — basic | 44.1 | 43.8 | 44 | 43.8 |
Effect of dilutive securities: | ||||
Stock options, restricted stock units, and employee stock purchase plan (in shares) | 0.3 | 0.2 | 0.3 | 0 |
Weighted average shares - diluted (in shares) | 44.4 | 44 | 44.3 | 43.8 |
Net income (loss) per common share: | ||||
Basic (in dollars per share) | $ 2.43 | $ 4.68 | $ 5.56 | $ (6.61) |
Diluted (in dollars per share) | $ 2.41 | $ 4.66 | $ 5.53 | $ (6.61) |
Stock options and restricted stock units excluded from calculation (in shares) | 7.2 | 7.9 | 7.4 | 6.6 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | Jan. 24, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 |
Collaborative Arrangement and Arrangement Other than Collaborative | ||||
Effective income tax rate (as a percent) | 20.00% | 28.00% | ||
Unrecognized tax benefits | $ 0 | $ 0 | ||
Interest expense related to uncertain tax positions | $ 0 | $ 0 | ||
Arena Pharmaceuticals, Inc. | ||||
Collaborative Arrangement and Arrangement Other than Collaborative | ||||
Upfront payment | $ 800,000,000 | $ 800,000,000 |
Segment Information - General (
Segment Information - General (Details) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($)segment | Jun. 30, 2019USD ($) | |
Net product sales, cost of product sales and gross profit by product | ||||
Number of operating segments | segment | 1 | |||
Net product sales | $ 362 | $ 373.6 | $ 718.3 | $ 736.2 |
Cost of product sales | 25.9 | 26.7 | 49.3 | 55.8 |
Gross profit | 336.1 | 346.9 | 669 | 680.4 |
Remodulin | ||||
Net product sales, cost of product sales and gross profit by product | ||||
Net product sales | 119 | 155.8 | 264.3 | 311.3 |
Cost of product sales | 5.3 | 4.5 | 11.3 | 10.6 |
Gross profit | 113.7 | 151.3 | 253 | 300.7 |
Tyvaso | ||||
Net product sales, cost of product sales and gross profit by product | ||||
Net product sales | 119.2 | 109.6 | 222.1 | 213.4 |
Cost of product sales | 4.6 | 3.5 | 9.7 | 7.9 |
Gross profit | 114.6 | 106.1 | 212.4 | 205.5 |
Orenitram | ||||
Net product sales, cost of product sales and gross profit by product | ||||
Net product sales | 75.4 | 54 | 144.4 | 112.4 |
Cost of product sales | 3.9 | 4 | 8.6 | 8.8 |
Gross profit | 71.5 | 50 | 135.8 | 103.6 |
Unituxin | ||||
Net product sales, cost of product sales and gross profit by product | ||||
Net product sales | 29 | 25.1 | 55.6 | 50 |
Cost of product sales | 3.9 | 2.2 | 6.2 | 7.3 |
Gross profit | 25.1 | 22.9 | 49.4 | 42.7 |
Adcirca | ||||
Net product sales, cost of product sales and gross profit by product | ||||
Net product sales | 19.4 | 29.1 | 31.9 | 49.1 |
Cost of product sales | 8.2 | 12.5 | 13.5 | 21.2 |
Gross profit | $ 11.2 | $ 16.6 | $ 18.4 | $ 27.9 |
Segment Information - Geographi
Segment Information - Geographic Information (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Revenues from external customers by geographic area | ||||
Total revenues | $ 362 | $ 373.6 | $ 718.3 | $ 736.2 |
United States | ||||
Revenues from external customers by geographic area | ||||
Total revenues | 350.8 | 339.5 | 677.5 | 669 |
Rest-of-World | ||||
Revenues from external customers by geographic area | ||||
Total revenues | $ 11.2 | $ 34.1 | $ 40.8 | $ 67.2 |
Segment Information - Concentra
Segment Information - Concentration Risk (Details) - distributor | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Segment Information | ||||
Number of distributors | 2 | |||
Net revenues | Customer concentration | Distributor 1 | ||||
Segment Information | ||||
Concentration risk, percentage | 55.00% | 54.00% | 55.00% | 56.00% |
Net revenues | Customer concentration | Distributor 2 | ||||
Segment Information | ||||
Concentration risk, percentage | 29.00% | 22.00% | 27.00% | 21.00% |
Litigation (Details)
Litigation (Details) - Liquidia Technologies, Inc. [Member] - petition | Mar. 30, 2020 | Apr. 30, 2020 |
Litigation | ||
Number of petitions | 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 |
Arena License Agreement (Detail
Arena License Agreement (Details) - Arena Pharmaceuticals, Inc. - USD ($) $ in Millions | Jan. 24, 2019 | Jun. 30, 2019 |
Collaborative Arrangement and Arrangement Other than Collaborative | ||
Upfront payment | $ 800 | $ 800 |
Marketing Approval In United States | Scenario, Plan | ||
Collaborative Arrangement and Arrangement Other than Collaborative | ||
Milestone payment to be made upon marketing approval | 250 | |
Marketing Approval In Any Of Japan France Italy United Kingdom Spain Or Germany | Scenario, Plan | ||
Collaborative Arrangement and Arrangement Other than Collaborative | ||
Milestone payment to be made upon marketing approval | $ 150 |