Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2023 | Oct. 31, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 000-19319 | |
Entity Registrant Name | VERTEX PHARMACEUTICALS INC / MA | |
Entity Incorporation, State or Country Code | MA | |
Entity Tax Identification Number | 04-3039129 | |
Entity Address, Address Line One | 50 Northern Avenue | |
Entity Address, City or Town | Boston | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02210 | |
City Area Code | 617 | |
Local Phone Number | 341-6100 | |
Title of 12(b) Security | Common Stock, $0.01 Par Value Per Share | |
Trading Symbol | VRTX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 257,683,184 | |
Entity Central Index Key | 0000875320 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Income - USD ($) shares in Millions, $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
Product revenues, net | $ 2,483.5 | $ 2,334.3 | $ 7,351.5 | $ 6,628 |
Costs and expenses: | ||||
Cost of sales | 318.7 | 289.4 | 894.2 | 797 |
Research and development expenses | 810 | 645 | 2,338.3 | 1,846.2 |
Acquired in-process research and development expenses | 51.7 | 29 | 509.3 | 92.9 |
Selling, general and administrative expenses | 263.8 | 246.8 | 767.5 | 677.3 |
Change in fair value of contingent consideration | 1.2 | (2.6) | (1.3) | (59.3) |
Total costs and expenses | 1,445.4 | 1,207.6 | 4,508 | 3,354.1 |
Income from operations | 1,038.1 | 1,126.7 | 2,843.5 | 3,273.9 |
Interest income | 167.9 | 46.2 | 435.2 | 58.6 |
Interest expense | (10.9) | (13.7) | (33.5) | (43.2) |
Other (expense) income, net | (15.9) | 17.2 | (13) | (133.7) |
Income before provision for income taxes | 1,179.2 | 1,176.4 | 3,232.2 | 3,155.6 |
Provision for income taxes | 143.9 | 245.9 | 581.4 | 652.5 |
Net income | $ 1,035.3 | $ 930.5 | $ 2,650.8 | $ 2,503.1 |
Net income per common share: | ||||
Basic (in dollars per share) | $ 4.01 | $ 3.63 | $ 10.29 | $ 9.78 |
Diluted (in dollars per share) | $ 3.97 | $ 3.59 | $ 10.18 | $ 9.68 |
Shares used in per share calculations: | ||||
Basic (in shares) | 258 | 256.5 | 257.7 | 255.8 |
Diluted (in shares) | 260.6 | 259.5 | 260.4 | 258.7 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Income - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Net income | $ 1,035.3 | $ 930.5 | $ 2,650.8 | $ 2,503.1 |
Other comprehensive income (loss): | ||||
Unrealized holding losses on marketable securities, net of tax of $1.7, zero, $5.2 and zero, respectively | (6.2) | (0.6) | (18.8) | (3.6) |
Unrealized gains on foreign currency forward contracts, net of tax of $(13.2), $(16.0), $(1.6) and $(34.3), respectively | 48 | 58.8 | 5.9 | 128.1 |
Foreign currency translation adjustment | (5) | (18.1) | 9.1 | (42.8) |
Total other comprehensive income (loss) | 36.8 | 40.1 | (3.8) | 81.7 |
Comprehensive income | $ 1,072.1 | $ 970.6 | $ 2,647 | $ 2,584.8 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive Income (Parenthetical) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Unrealized holding losses on marketable securities, tax | $ 1.7 | $ 0 | $ 5.2 | $ 0 |
Unrealized gains (losses) on foreign currency forward contracts, tax | $ (13.2) | $ (16) | $ (1.6) | $ (34.3) |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 11,110.2 | $ 10,504 |
Marketable securities | 818 | 274.5 |
Accounts receivable, net | 1,538.7 | 1,442.2 |
Inventories | 688.7 | 460.6 |
Prepaid expenses and other current assets | 540.2 | 553.5 |
Total current assets | 14,695.8 | 13,234.8 |
Property and equipment, net | 1,124 | 1,108.4 |
Goodwill | 1,088 | 1,088 |
Intangible assets | 603.6 | 603.6 |
Deferred tax assets | 1,729.1 | 1,246.9 |
Operating lease assets | 310.5 | 347.4 |
Long-term marketable securities | 1,700 | 112.2 |
Other assets | 475.2 | 409.6 |
Total assets | 21,726.2 | 18,150.9 |
Current liabilities: | ||
Accounts payable | 375.9 | 303.9 |
Accrued expenses | 2,907.3 | 2,126.7 |
Other current liabilities | 316.2 | 311.5 |
Total current liabilities | 3,599.4 | 2,742.1 |
Long-term finance lease liabilities | 390.3 | 430.8 |
Long-term operating lease liabilities | 354.4 | 379.5 |
Other long-term liabilities | 869.3 | 685.8 |
Total liabilities | 5,213.4 | 4,238.2 |
Commitments and contingencies | 0 | 0 |
Shareholders’ equity: | ||
Preferred stock, $0.01 par value; 1,000,000 shares authorized; none issued and outstanding | 0 | 0 |
Common stock, $0.01 par value; 500,000,000 shares authorized, 257,828,508 and 257,011,628 shares issued and outstanding, respectively | 2.6 | 2.6 |
Additional paid-in capital | 7,339.6 | 7,386.5 |
Accumulated other comprehensive (loss) income | (3) | 0.8 |
Retained earnings | 9,173.6 | 6,522.8 |
Total shareholders’ equity | 16,512.8 | 13,912.7 |
Total liabilities and shareholders’ equity | $ 21,726.2 | $ 18,150.9 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 1,000,000 | 1,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 500,000,000 | 500,000,000 |
Common stock, shares issued (in shares) | 257,828,508 | 257,011,628 |
Common stock, shares outstanding (in shares) | 257,828,508 | 257,011,628 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Shareholders' Equity - USD ($) $ in Millions | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Retained Earnings |
Beginning balance (in shares) at Dec. 31, 2021 | 254,500,000 | ||||
Beginning balance at Dec. 31, 2021 | $ 10,100 | $ 2.5 | $ 6,880.8 | $ 15.9 | $ 3,200.8 |
Increase (Decrease) in Stockholders' Equity | |||||
Other comprehensive income (loss), net of tax | 81.7 | 81.7 | |||
Net income | 2,503.1 | 2,503.1 | |||
Common stock withheld for employee tax obligations (in shares) | (700,000) | ||||
Common stock withheld for employee tax obligations | (169.9) | $ 0 | (169.9) | ||
Issuance of common stock under benefit plans (in shares) | 2,800,000 | ||||
Issuance of common stock under benefit plans | 135.3 | $ 0.1 | 135.2 | ||
Stock-based compensation expense | 379.4 | 379.4 | |||
Ending balance (in shares) at Sep. 30, 2022 | 256,600,000 | ||||
Ending balance at Sep. 30, 2022 | 13,029.6 | $ 2.6 | 7,225.5 | 97.6 | 5,703.9 |
Beginning balance (in shares) at Jun. 30, 2022 | 256,000,000 | ||||
Beginning balance at Jun. 30, 2022 | 11,933.5 | $ 2.6 | 7,100 | 57.5 | 4,773.4 |
Increase (Decrease) in Stockholders' Equity | |||||
Other comprehensive income (loss), net of tax | 40.1 | 40.1 | |||
Net income | 930.5 | 930.5 | |||
Common stock withheld for employee tax obligations (in shares) | (200,000) | ||||
Common stock withheld for employee tax obligations | (48) | $ 0 | (48) | ||
Issuance of common stock under benefit plans (in shares) | 800,000 | ||||
Issuance of common stock under benefit plans | 38.2 | $ 0 | 38.2 | ||
Stock-based compensation expense | 135.3 | 135.3 | |||
Ending balance (in shares) at Sep. 30, 2022 | 256,600,000 | ||||
Ending balance at Sep. 30, 2022 | $ 13,029.6 | $ 2.6 | 7,225.5 | 97.6 | 5,703.9 |
Beginning balance (in shares) at Dec. 31, 2022 | 257,011,628 | 257,000,000 | |||
Beginning balance at Dec. 31, 2022 | $ 13,912.7 | $ 2.6 | 7,386.5 | 0.8 | 6,522.8 |
Increase (Decrease) in Stockholders' Equity | |||||
Other comprehensive income (loss), net of tax | (3.8) | (3.8) | |||
Net income | $ 2,650.8 | 2,650.8 | |||
Repurchase of common stock (in shares) | (891,060) | (900,000) | |||
Repurchase of common stock | $ (284.1) | $ 0 | (284.1) | ||
Common stock withheld for employee tax obligations (in shares) | (700,000) | ||||
Common stock withheld for employee tax obligations | (222.9) | $ 0 | (222.9) | ||
Issuance of common stock under benefit plans (in shares) | 2,400,000 | ||||
Issuance of common stock under benefit plans | 85.7 | $ 0 | 85.7 | ||
Stock-based compensation expense | $ 374.4 | 374.4 | |||
Ending balance (in shares) at Sep. 30, 2023 | 257,828,508 | 257,800,000 | |||
Ending balance at Sep. 30, 2023 | $ 16,512.8 | $ 2.6 | 7,339.6 | (3) | 9,173.6 |
Beginning balance (in shares) at Jun. 30, 2023 | 257,800,000 | ||||
Beginning balance at Jun. 30, 2023 | 15,470.2 | $ 2.6 | 7,369.1 | (39.8) | 8,138.3 |
Increase (Decrease) in Stockholders' Equity | |||||
Other comprehensive income (loss), net of tax | 36.8 | 36.8 | |||
Net income | 1,035.3 | 1,035.3 | |||
Repurchase of common stock (in shares) | (400,000) | ||||
Repurchase of common stock | (123) | $ 0 | (123) | ||
Common stock withheld for employee tax obligations (in shares) | (100,000) | ||||
Common stock withheld for employee tax obligations | (53.2) | $ 0 | (53.2) | ||
Issuance of common stock under benefit plans (in shares) | 500,000 | ||||
Issuance of common stock under benefit plans | 15 | $ 0 | 15 | ||
Stock-based compensation expense | $ 131.7 | 131.7 | |||
Ending balance (in shares) at Sep. 30, 2023 | 257,828,508 | 257,800,000 | |||
Ending balance at Sep. 30, 2023 | $ 16,512.8 | $ 2.6 | $ 7,339.6 | $ (3) | $ 9,173.6 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Millions | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net income | $ 2,650.8 | $ 2,503.1 |
Adjustments to reconcile net income to net cash provided by operating activities: | ||
Stock-based compensation expense | 372.6 | 379.8 |
Depreciation expense | 122.3 | 109.9 |
Deferred income taxes | (405.5) | (424) |
Losses on equity securities | 0.2 | 143.1 |
Decrease in fair value of contingent consideration | (1.3) | (59.3) |
Other non-cash items, net | (9.6) | (32.8) |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (99.5) | (368.8) |
Inventories | (252.9) | (58.1) |
Prepaid expenses and other assets | (94.4) | (41.9) |
Accounts payable | 80.5 | (39.1) |
Accrued expenses | 786.1 | 980.3 |
Other liabilities | 153.4 | (40.7) |
Net cash provided by operating activities | 3,302.7 | 3,051.5 |
Cash flows from investing activities: | ||
Purchases of available-for-sale debt securities | (2,798) | (417.8) |
Sales and maturities of available-for-sale debt securities | 621 | 435.9 |
Purchases of property and equipment | (142.3) | (171.1) |
Sale of equity securities | 95.1 | 0 |
Investment in equity securities and notes receivable | (31) | (47.8) |
Payment to acquire ViaCyte, Inc., net of cash acquired | 0 | (295.9) |
Net cash used in investing activities | (2,255.2) | (496.7) |
Cash flows from financing activities: | ||
Issuances of common stock under benefit plans | 88.2 | 134.7 |
Repurchases of common stock | (278.1) | 0 |
Payments in connection with common stock withheld for employee tax obligations | (222.9) | (169.9) |
Payments on finance leases | (32.9) | (75.1) |
Other financing activities | 3.3 | 2.4 |
Net cash used in financing activities | (442.4) | (107.9) |
Effect of changes in exchange rates on cash | (0.5) | (70) |
Net increase in cash, cash equivalents and restricted cash | 604.6 | 2,376.9 |
Cash, cash equivalents and restricted cash—beginning of period | 10,512 | 6,800.1 |
Cash, cash equivalents and restricted cash—end of period | 11,116.6 | 9,177 |
Supplemental disclosure of cash flow information: | ||
Cash paid for income taxes | 919.1 | 840.1 |
Cash paid for interest | $ 32.6 | $ 41.1 |
Basis of Presentation and Accou
Basis of Presentation and Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Accounting Policies | Basis of Presentation and Accounting Policies Basis of Presentation The accompanying condensed consolidated financial statements are unaudited and have been prepared by Vertex Pharmaceuticals Incorporated (“Vertex,” “we,” “us” or “our”) in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The condensed consolidated financial statements reflect the operations of Vertex and our wholly-owned subsidiaries. All material intercompany balances and transactions have been eliminated. We have reclassified certain items from the prior year’s condensed consolidated balance sheet to conform to the current year’s presentation. We operate in one segment, pharmaceuticals. Certain information and footnote disclosures normally included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (the “2022 Annual Report on Form 10-K”) have been condensed or omitted. These interim financial statements, in the opinion of management, reflect all normal recurring adjustments necessary for a fair presentation of the financial position and results of income for the interim periods ended September 30, 2023 and 2022. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full fiscal year. These interim financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2022, which are contained in our 2022 Annual Report on Form 10-K. Use of Estimates The preparation of condensed consolidated financial statements in accordance with U.S. GAAP requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of our condensed consolidated financial statements, and the amounts of revenues and expenses during the reported periods. We base our estimates on historical experience and various other assumptions, including in certain circumstances future projections that we believe to be reasonable under the circumstances. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known. Recently Adopted and Issued Accounting Standards For a discussion of recently adopted accounting pronouncements please refer to Note A, “Nature of Business and Accounting Policies,” in our 2022 Annual Report on Form 10-K. We do not expect any recently issued accounting standards to have a significant impact on our condensed consolidated financial statements. Summary of Significant Accounting Policies Our significant accounting policies are described in Note A, “Nature of Business and Accounting Policies,” in our 2022 Annual Report on Form 10-K. |
Revenue Recognition
Revenue Recognition | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | Revenue Recognition Disaggregation of Revenue Revenues by Product “Product revenues, net” consisted of the following: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in millions) TRIKAFTA/KAFTRIO $ 2,274.3 $ 2,010.5 $ 6,611.4 $ 5,665.3 KALYDECO 112.8 139.4 363.1 417.1 ORKAMBI 63.0 146.2 281.8 399.9 SYMDEKO/SYMKEVI 33.4 38.2 95.2 145.7 Total product revenues, net $ 2,483.5 $ 2,334.3 $ 7,351.5 $ 6,628.0 Product Revenues by Geographic Location “Product revenues, net” by geographic region, based on the location of the customer, consisted of the following: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in millions) United States $ 1,554.2 $ 1,455.6 $ 4,465.8 $ 4,238.9 Outside of the United States Europe 766.5 730.5 2,373.7 2,018.3 Other 162.8 148.2 512.0 370.8 Total product revenues outside of the United States 929.3 878.7 2,885.7 2,389.1 Total product revenues, net $ 2,483.5 $ 2,334.3 $ 7,351.5 $ 6,628.0 Contract Liabilities We had contract liabilities of $157.1 million and $159.6 million as of September 30, 2023 and December 31, 2022, respectively, related to annual contracts with government-owned and supported customers in international markets that limit the amount of annual reimbursement we can receive. Upon exceeding the annual reimbursement amount, products are provided free of charge, which is a material right. These contracts include upfront payments and fees. We defer a portion of the consideration received for shipments made up to the annual reimbursement limit as a portion of “Other current liabilities.” The deferred amount is recognized as revenue when the free products are shipped. Our product revenue contracts include performance obligations that are one year or less. Our contract liabilities at the end of each fiscal year relate to contracts with annual reimbursement limits in international markets in which the annual period associated with the contract is not the same as our fiscal year. In these markets, we recognize revenues related to performance obligations satisfied in previous years; however, these revenues do not relate to any performance obligations that were satisfied more than 12 months prior to the beginning of the current year. |
Acquired In-Process Research an
Acquired In-Process Research and Development and Other Arrangements | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Acquired In-Process Research and Development and Other Arrangements | Acquired In-Process Research and Development and Other Arrangements We have entered into numerous agreements with third parties to collaborate on research, development and commercialization programs, license technologies, or acquire assets. Our “Acquired in-process research and development expenses” included $51.7 million and $509.3 million for the three and nine months ended September 30, 2023, respectively, and $29.0 million and $92.9 million, for the three and nine months ended September 30, 2022, respectively, related to upfront, contingent milestone, or other payments pursuant to our business development transactions, including collaborations, licenses of third-party technologies, and asset acquisitions that qualify as in-process research and development. Our collaboration, licensing and asset acquisition agreements that had a significant impact on our financial statements for the three and nine months ended September 30, 2023 and 2022, or were new or materially revised during the three and nine months ended September 30, 2023, are described below. Additional agreements were described in Note B, “Acquired In-Process Research and Development and Other Arrangements,” of our 2022 Annual Report on Form 10-K. In-license Agreements We have entered into several in-license agreements to advance and obtain access to technologies and services related to our research and early-development activities. We are generally required to make an upfront payment upon execution of our license agreements; development, regulatory and commercialization milestones payments upon the achievement of certain product research, development and commercialization objectives; and royalty payments on future sales, if any, of commercial products resulting from our collaborations. Pursuant to the terms of our in-license agreements, our collaborators typically lead the discovery efforts and we lead all preclinical, development and commercialization activities associated with the advancement of any product candidates and fund all expenses. We typically can terminate our in-license agreements by providing advance notice to our collaborators. Our license agreements may be terminated by either party for a material breach by the other, subject to notice and cure provisions. Unless earlier terminated, these license agreements generally remain in effect until the date on which the royalty term and all payment obligations with respect to all products in all countries have expired. CRISPR Therapeutics AG CRISPR-Cas9 Gene-editing Therapies Agreements In 2015, we entered into a strategic collaboration, option, and license agreement (the “CRISPR Agreement”) with CRISPR Therapeutics AG and its affiliates (“CRISPR”) to collaborate on the discovery and development of potential new treatments aimed at the underlying genetic causes of human diseases using CRISPR-Cas9 gene-editing technology. We had the exclusive right to license certain targets. In 2019, we elected to exclusively license three targets, including cystic fibrosis, pursuant to the CRISPR Agreement. For each of the three targets that we elected to license, CRISPR has the potential to receive up to an additional $410.0 million in development, regulatory and commercial milestones as well as royalties on resulting net product sales. In 2017, we entered into a joint development and commercialization agreement with CRISPR (the “CRISPR JDCA”), which we amended and restated in 2021, pursuant to the terms of the CRISPR Agreement. Under the CRISPR JDCA, we and CRISPR are co-developing and preparing to co-commercialize exagamglogene autotemcel (“exa-cel”), for the treatment of hemoglobinopathies, including treatments for sickle cell disease and transfusion-dependent beta thalassemia. Pursuant to the CRISPR JDCA, we lead global development, manufacturing, and commercialization of exa-cel, with support from CRISPR. We also conduct all research, development, manufacturing, and commercialization activities relating to other product candidates and products under the CRISPR JDCA throughout the world subject to CRISPR’s reserved right to conduct certain activities. In connection with the CRISPR JDCA, CRISPR has the potential to receive a one-time $200.0 million milestone payment upon receipt of the first marketing approval of exa-cel from the U.S. Food and Drug Administration or the European Commission. We account for the CRISPR JDCA as a cost-sharing arrangement, with costs incurred related to exa-cel allocated 60% to us and 40% to CRISPR, subject to certain adjustments. We recognized the net impact of the CRISPR JDCA as “Research and development expenses” of $74.9 million and $45.5 million during the three months ended September 30, 2023 and 2022, respectively, and $193.2 million and $120.6 million during the nine months ended September 30, 2023 and 2022, respectively; and as “Selling, general and administrative expenses” of $26.0 million and $13.5 million during the three months ended September 30, 2023 and 2022, respectively, and $66.1 million and $35.3 million during the nine months ended September 30, 2023 and 2022, respectively. In March 2023, we entered into a non-exclusive license agreement (“the CRISPR T1D Agreement”) for the use of CRISPR’s CRISPR-Cas9 gene-editing technology to accelerate the development of our hypoimmune cell therapies for type 1 diabetes. Pursuant to the CRISPR T1D Agreement, we made a $100.0 million upfront payment to CRISPR. In the second quarter of 2023, we achieved a research milestone that resulted in a $70.0 million payment to CRISPR in the third quarter of 2023. CRISPR is eligible to receive up to an additional $160.0 million in research, development, regulatory and commercial milestones for any products that may result from the agreement, as well as royalties on resulting net product sales. We determined that substantially all the fair value of the collaboration agreement was attributable to in-process research and development and no substantive processes were acquired that would constitute a business. We concluded that there is no alternative future use for the acquired in-process research and development and recorded the upfront payment and the research milestone to “Acquired in-process research and development expenses” in the first and second quarters of 2023, respectively, resulting in $170.0 million of “Acquired in-process research and development expenses” in the nine months ended September 30, 2023. Entrada Therapeutics, Inc. In February 2023, we closed a strategic collaboration and license agreement (the “Entrada Agreement”) with Entrada Therapeutics, Inc. (“Entrada”) focused on discovering and developing intracellular Endosomal Escape Vehicle (EEV) therapeutics for myotonic dystrophy type 1 (“DM1”). Upon closing, we made an upfront payment of $225.1 million to Entrada, and purchased $24.9 million of Entrada’s common stock in connection with the Entrada Agreement. Entrada is eligible to receive up to an additional $485.0 million in research, development, regulatory and commercial milestones for any products that may result from the Entrada Agreement, as well as royalties on resulting net product sales. We determined that substantially all the fair value of the collaboration agreement was attributable to in-process research and development and no substantive processes were acquired that would constitute a business. We concluded that there is no alternative future use for the acquired in-process research and development and recorded the upfront payment to “Acquired in-process research and development expenses” in the first quarter of 2023. The investment in Entrada’s common stock is recorded at fair value on our condensed consolidated balance sheet within “Marketable securities.” Verve Therapeutics, Inc. In July 2022, we entered into a research collaboration with Verve Therapeutics, Inc. (“Verve”) focused on discovering and developing an in vivo gene-editing program for a liver disease. Under the terms of the agreement, we made a $25.0 million upfront payment to Verve and purchased $35.0 million of Verve’s common stock. We concluded that there is no alternative future use for the acquired in-process research and development and recorded the upfront payment to “Acquired in-process research and development expenses.” The investment in Verve’s common stock is recorded at fair value on our condensed consolidated balance sheet within “Marketable securities.” Asset Acquisitions Septerna, Inc. - Novel G Protein-coupled Receptor Program In September 2023, pursuant to an asset purchase agreement, we acquired a novel G protein-coupled receptor (“GPCR”) program from Septerna, Inc. We determined that substantially all the fair value acquired is concentrated in the GPCR in-process research and development asset, which does not constitute a business, and for which we determined there is no alternative future use. As a result, we recorded $47.5 million to “Acquired in-process research and development expenses” in the three and nine months ended September 30, 2023. Catalyst Biosciences, Inc. - Complement 3 Degrader Program In May 2022, pursuant to an asset purchase agreement, we acquired Catalyst Biosciences, Inc.’s portfolio of protease medicines that target the complement system (the “complement portfolio”) and related intellectual property, including CB 2782-PEG, which is a pre-clinical complement component 3 degrader program for geographic atrophy in dry age-related macular degeneration. We determined that substantially all the fair value acquired is concentrated in the CB-2782 PEG in- process research and development assets, which do not constitute a business, and for which we determined there is no alternative future use. As a result, we recorded our $60.0 million upfront payment to “Acquired in-process research and development expenses” in the three and nine months ended September 30, 2022. Cystic Fibrosis Foundation In 2004, we entered into a collaboration agreement with the Cystic Fibrosis Foundation, as successor in interest to the Cystic Fibrosis Foundation Therapeutics, Inc., to support research and development activities. Pursuant to the collaboration agreement, as amended, we have agreed to pay tiered royalties ranging from single digits to sub-teens on covered compounds first synthesized and/or tested during a research term on or before February 28, 2014, including ivacaftor, lumacaftor and tezacaftor and royalties ranging from low-single digits to mid-single digits on potential net sales of certain compounds first synthesized and/or tested between March 1, 2014 and August 31, 2016, including elexacaftor. We do not have any royalty obligations on compounds first synthesized and tested on or after September 1, 2016. For combination products, such as ORKAMBI, SYMDEKO/SYMKEVI and TRIKAFTA/KAFTRIO, sales are allocated equally to each of the active pharmaceutical ingredients in the combination product. We record expenses related to these royalty obligations to “Cost of sales.” |
Earnings Per Share
Earnings Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Earnings Per Share | Earnings Per Share The following table sets forth the computation of basic and diluted net income per common share for the periods ended: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in millions, except per share amounts) Net income $ 1,035.3 $ 930.5 $ 2,650.8 $ 2,503.1 Basic weighted-average common shares outstanding 258.0 256.5 257.7 255.8 Effect of potentially dilutive securities: Stock options 1.2 1.4 1.2 1.4 Restricted stock units (including PSUs) 1.4 1.6 1.5 1.4 Employee stock purchase program 0.0 0.0 0.0 0.1 Diluted weighted-average common shares outstanding 260.6 259.5 260.4 258.7 Basic net income per common share $ 4.01 $ 3.63 $ 10.29 $ 9.78 Diluted net income per common share $ 3.97 $ 3.59 $ 10.18 $ 9.68 We did not include the securities in the following table in the computation of the diluted net income per common share because the effect would have been anti-dilutive during each period: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in millions) Stock options — — 0.0 0.0 Unvested restricted stock units (including PSUs) — 0.0 0.2 0.2 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The following fair value hierarchy is used to classify assets and liabilities based on observable inputs and unobservable inputs used in order to determine the fair value of our financial assets and liabilities: Level 1: Quoted prices in active markets for identical assets or liabilities. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Level 2: Observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active. Level 3: Unobservable inputs based on our assessment of the assumptions that market participants would use in pricing the asset or liability. Our investment strategy is focused on capital preservation. We invest in instruments that meet the credit quality standards outlined in our investment policy, which also limits the amount of credit exposure to any one issue or type of instrument. We maintain strategic equity investments separately from the investment policy that governs our other cash, cash equivalents and marketable securities as described in Note F, “Marketable Securities and Equity Investments.” Additionally, we utilize foreign currency forward contracts intended to mitigate the effect of changes in foreign exchange rates on our condensed consolidated statement of income. The following tables set forth our financial assets and liabilities subject to fair value measurements by level within the fair value hierarchy (and does not include $5.5 billion and $3.1 billion of cash as of September 30, 2023 and December 31, 2022, respectively): As of September 30, 2023 As of December 31, 2022 Total Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 (in millions) Financial instruments carried at fair value (asset positions): Cash equivalents: Money market funds $ 3,753.4 $ 3,753.4 $ — $ — $ 5,162.6 $ 5,162.6 $ — $ — Time deposits 1,550.0 — 1,550.0 — 2,000.0 — 2,000.0 — U.S. Treasury securities 236.8 236.8 — — — — — — Corporate debt securities — — — — 5.8 — 5.8 — Commercial paper 96.5 — 96.5 — 204.5 — 204.5 — Marketable securities: Corporate equity securities 46.4 46.4 — — 116.8 88.8 28.0 — U.S. Treasury securities 408.2 408.2 — — — — — — Government-sponsored enterprise securities 421.0 421.0 — — 127.1 127.1 — — Asset-backed securities 237.8 — 237.8 — — — — — Certificates of deposit 31.7 — 31.7 — — — — — Corporate debt securities 1,214.2 — 1,214.2 — 87.0 — 87.0 — Commercial paper 158.7 — 158.7 — 55.8 — 55.8 — Prepaid expenses and other current assets: Foreign currency forward contracts 37.8 — 37.8 — 47.5 — 47.5 — Other assets: Foreign currency forward contracts 3.4 — 3.4 — 0.8 — 0.8 — Total financial assets $ 8,195.9 $ 4,865.8 $ 3,330.1 $ — $ 7,807.9 $ 5,378.5 $ 2,429.4 $ — Financial instruments carried at fair value (liability positions): Other current liabilities: Foreign currency forward contracts $ (0.7) $ — $ (0.7) $ — $ (14.3) $ — $ (14.3) $ — Contingent consideration (15.0) — — (15.0) (14.6) — — (14.6) Other long-term liabilities: Foreign currency forward contracts — — — — (0.9) — (0.9) — Contingent consideration (112.7) — — (112.7) (114.4) — — (114.4) Total financial liabilities $ (128.4) $ — $ (0.7) $ (127.7) $ (144.2) $ — $ (15.2) $ (129.0) Please refer to Note F, “Marketable Securities and Equity Investments,” for the carrying amount and related unrealized gains (losses) by type of investment. Fair Value of Corporate Equity Securities We classify our investments in publicly traded corporate equity securities as “Marketable securities” on our condensed consolidated balance sheets. Generally, our investments in the common stock of publicly traded companies are valued based on Level 1 inputs because they have readily determinable fair values. However, certain of our investments in publicly traded companies have been or continue to be valued based on Level 2 inputs due to transfer restrictions associated with these investments. As of September 30, 2023, one of our investments in publicly traded corporate equity securities was subject to a contractual sales restriction expiring partially in 2024 and partially in 2025 with a total fair value of $25.5 million. We purchased this investment directly from the publicly traded company in the first quarter of 2023, and do not anticipate any circumstances that would cause this restriction to lapse prior to the periods listed above. Please refer to Note F, “Marketable Securities and Equity Investments,” for further information on these investments. Fair Value of Contingent Consideration In 2019, we acquired Exonics Therapeutics, Inc. (“Exonics”), a privately-held company focused on creating transformative gene-editing therapies to repair mutations that cause Duchenne muscular dystrophy (“DMD”) and other severe neuromuscular diseases, including DM1. Our Level 3 contingent consideration liabilities are related to $678.3 million of development and regulatory milestones potentially payable to former Exonics equity holders. We base our estimates of the probability of achieving the milestones relevant to the fair value of contingent payments, which could include milestone, royalty and option payments, on industry data attributable to rare diseases and our knowledge of the progress and viability of the programs. The discount rates used in the valuation model for contingent payments, which were between 5.5% and 6.5% as of September 30, 2023, represent a measure of credit risk and market risk associated with settling the liabilities. Significant judgment is used in determining the appropriateness of these assumptions at each reporting period. The following table represents a rollforward of the fair value of our contingent consideration liabilities: Nine Months Ended September 30, 2023 (in millions) Balance at December 31, 2022 $ 129.0 Decrease in fair value of contingent payments (1.3) Balance at September 30, 2023 $ 127.7 In November 2023, we determined that additional pre-clinical studies of the delivery system for our gene-editing components for DMD will be required. Any potential impact on the fair value of our contingent consideration liabilities will be recognized as of December 31, 2023. |
Marketable Securities and Equit
Marketable Securities and Equity Investments | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities and Equity Investments | Marketable Securities and Equity Investments A summary of our cash equivalents and marketable securities, which are recorded at fair value (and do not include $5.5 billion and $3.1 billion of cash as of September 30, 2023 and December 31, 2022, respectively), is shown below: As of September 30, 2023 As of December 31, 2022 Amortized Cost Gross Gross Fair Value Amortized Cost Gross Gross Fair Value (in millions) Cash equivalents: Money market funds $ 3,753.4 $ — $ — $ 3,753.4 $ 5,162.6 $ — $ — $ 5,162.6 Time deposits 1,550.0 — — 1,550.0 2,000.0 — — 2,000.0 U.S. Treasury securities 236.8 — — 236.8 — — — — Corporate debt securities — — — — 5.8 — — 5.8 Commercial paper 96.5 — — 96.5 204.5 — — 204.5 Total cash equivalents $ 5,636.7 $ — $ — $ 5,636.7 $ 7,372.9 $ — $ — $ 7,372.9 Marketable securities: U.S. Treasury securities $ 414.6 $ 0.1 $ (6.5) $ 408.2 $ — $ — $ — $ — Government-sponsored enterprise securities 422.9 — (1.9) 421.0 127.0 0.2 (0.1) 127.1 Asset-backed securities 239.3 0.0 (1.5) 237.8 — — — — Certificates of deposit 31.7 0.0 — 31.7 — — — — Corporate debt securities 1,228.4 0.0 (14.2) 1,214.2 87.2 — (0.2) 87.0 Commercial paper 158.8 0.0 (0.1) 158.7 55.8 — — 55.8 Total marketable debt securities 2,495.7 0.1 (24.2) 2,471.6 270.0 0.2 (0.3) 269.9 Corporate equity securities 72.1 0.5 (26.2) 46.4 104.4 30.9 (18.5) 116.8 Total marketable securities $ 2,567.8 $ 0.6 $ (50.4) $ 2,518.0 $ 374.4 $ 31.1 $ (18.8) $ 386.7 Available-for-sale debt securities were classified on our condensed consolidated balance sheets at fair value as follows: As of September 30, 2023 As of December 31, 2022 (in millions) Cash and cash equivalents $ 4,086.7 $ 5,372.9 Marketable securities 771.6 157.7 Long-term marketable securities 1,700.0 112.2 Total $ 6,558.3 $ 5,642.8 Available-for-sale debt securities by contractual maturity were as follows: As of September 30, 2023 As of December 31, 2022 (in millions) Matures within one year $ 4,858.3 $ 5,530.6 Matures after one year through five years 1,700.0 112.2 Total $ 6,558.3 $ 5,642.8 We did not record any allowances for credit losses to adjust the fair value of available-for-sale debt securities or gross realized gains or losses in the three and nine months ended September 30, 2023 and 2022. As of September 30, 2023, we held available-for-sale debt securities with a total fair value of $2.28 billion that were in unrealized loss positions totaling $24.2 million; however, none of these investments had been in an unrealized loss position for greater than twelve months. We record changes in the fair value of our investments in corporate equity securities to “Other (expense) income, net” in our condensed consolidated statements of income. During the three and nine months ended September 30, 2023 and 2022, our net unrealized (losses) gains on corporate equity securities held at the conclusion of each period were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in millions) Net unrealized (losses) gains $ (6.2) $ 16.7 $ (7.1) $ (143.1) During the nine months ended September 30, 2023, we received proceeds of $95.1 million related to the sale of the common stock of a publicly traded company, which had a total original cost basis of $57.3 million. There were no sales of the common stock of publicly traded companies during the nine months ended September 30, 2022. As of September 30, 2023, the carrying value of our equity investments without readily determinable fair values, which are recorded in “Other assets” on our condensed consolidated balance sheets, was $98.6 million. |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income (Loss) | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Accumulated Other Comprehensive Income (Loss) | Accumulated Other Comprehensive Income (Loss) The following table summarizes the changes in accumulated other comprehensive income (loss) by component: Unrealized Holding Gains (Losses), Net of Tax Foreign Currency Translation Adjustment On Available-For-Sale Debt Securities On Foreign Currency Forward Contracts Total (in millions) Balance at December 31, 2022 $ (25.0) $ (0.1) $ 25.9 $ 0.8 Other comprehensive income (loss) before reclassifications 9.1 (18.8) 31.8 22.1 Amounts reclassified from accumulated other comprehensive income (loss) — — (25.9) (25.9) Net current period other comprehensive income (loss) 9.1 (18.8) 5.9 (3.8) Balance at September 30, 2023 $ (15.9) $ (18.9) $ 31.8 $ (3.0) Balance at December 31, 2021 $ (13.6) $ (0.5) $ 30.0 $ 15.9 Other comprehensive (loss) income before reclassifications (42.8) (3.6) 230.2 183.8 Amounts reclassified from accumulated other comprehensive income (loss) — — (102.1) (102.1) Net current period other comprehensive (loss) income (42.8) (3.6) 128.1 81.7 Balance at September 30, 2022 $ (56.4) $ (4.1) $ 158.1 $ 97.6 |
Hedging
Hedging | 9 Months Ended |
Sep. 30, 2023 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Hedging | Hedging Foreign currency forward contracts - Designated as hedging instruments We maintain a hedging program intended to mitigate the effect of changes in foreign exchange rates for a portion of our forecasted product revenues denominated in certain foreign currencies. The program includes foreign currency forward contracts that are designated as cash flow hedges under U.S. GAAP having contractual durations from one condensed consolidated statements of income in the same period that we recognize the product revenues that were impacted by the hedged foreign exchange rate changes. We formally document the relationship between foreign currency forward contracts (hedging instruments) and forecasted product revenues (hedged items), as well as our risk management objective and strategy for undertaking various hedging activities, which includes matching all foreign currency forward contracts that are designated as cash flow hedges to forecasted transactions. We also formally assess, both at the hedge’s inception and on an ongoing basis, whether the foreign currency forward contracts are highly effective in offsetting changes in cash flows of hedged items on a prospective and retrospective basis. If we were to determine that a (i) foreign currency forward contract is not highly effective as a cash flow hedge, (ii) foreign currency forward contract has ceased to be a highly effective hedge or (iii) forecasted transaction is no longer probable of occurring, we would discontinue hedge accounting treatment prospectively. We measure effectiveness based on the change in fair value of the forward contracts and the fair value of the hypothetical foreign currency forward contracts with terms that match the critical terms of the risk being hedged. As of September 30, 2023, all hedges were determined to be highly effective. We consider the impact of our counterparties’ credit risk on the fair value of the foreign currency forward contracts. As of September 30, 2023 and December 31, 2022, credit risk did not change the fair value of our foreign currency forward contracts. The following table summarizes the notional amount in U.S. dollars of our outstanding foreign currency forward contracts designated as cash flow hedges under U.S. GAAP: As of September 30, 2023 As of December 31, 2022 Foreign Currency (in millions) Euro $ 1,343.3 $ 1,497.7 Canadian dollar 192.6 216.3 British pound sterling 191.9 247.4 Australian dollar 136.2 174.9 Swiss Franc 51.7 65.2 Total foreign currency forward contracts $ 1,915.7 $ 2,201.5 Foreign currency forward contracts - Not designated as hedging instruments We also enter into foreign currency forward contracts with contractual maturities of less than one month, which are designed to mitigate the effect of changes in foreign exchange rates on monetary assets and liabilities, including intercompany balances. These contracts are not designated as hedging instruments under U.S. GAAP. We recognize realized gains and losses for such contracts in “Other (expense) income, net” in our condensed consolidated statements of income each period. As of September 30, 2023, the notional amount of our outstanding foreign currency forward contracts where hedge accounting under U.S. GAAP is not applied was $922.8 million. During the three and nine months ended September 30, 2023 and 2022, we recognized the following related to foreign currency forward contracts in our condensed consolidated statements of income: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in millions) Designated as hedging instruments - Reclassified from AOCI Product revenues, net $ 2.8 $ 65.2 $ 33.0 $ 130.3 Not designated as hedging instruments Other (expense) income, net $ (22.0) $ (22.1) $ (17.8) $ (38.9) Total reported in the Condensed Consolidated Statements of Income Product revenues, net $ 2,483.5 $ 2,334.3 $ 7,351.5 $ 6,628.0 Other (expense) income, net $ (15.9) $ 17.2 $ (13.0) $ (133.7) The following table summarizes the fair value of our outstanding foreign currency forward contracts designated as cash flow hedges under U.S. GAAP included on our condensed consolidated balance sheets: As of September 30, 2023 Assets Liabilities Classification Fair Value Classification Fair Value (in millions) Prepaid expenses and other current assets $ 37.8 Other current liabilities $ (0.7) Other assets 3.4 Other long-term liabilities — Total assets $ 41.2 Total liabilities $ (0.7) As of December 31, 2022 Assets Liabilities Classification Fair Value Classification Fair Value (in millions) Prepaid expenses and other current assets $ 47.5 Other current liabilities $ (14.3) Other assets 0.8 Other long-term liabilities (0.9) Total assets $ 48.3 Total liabilities $ (15.2) As of September 30, 2023, we expect the amounts that are related to foreign exchange forward contracts designated as cash flow hedges under U.S. GAAP recorded in “Prepaid expenses and other current assets” and “Other current liabilities” to be reclassified to earnings within twelve months. We present the fair value of our foreign currency forward contracts on a gross basis within our condensed consolidated balance sheets. The following table summarizes the potential effect of offsetting derivatives by type of financial instrument designated as cash flow hedges under U.S. GAAP on our condensed consolidated balance sheets: As of September 30, 2023 Gross Amounts Recognized Gross Amounts Offset Gross Amounts Presented Gross Amounts Not Offset Legal Offset Foreign currency forward contracts (in millions) Total assets $ 41.2 $ — $ 41.2 $ (0.7) $ 40.5 Total liabilities (0.7) — (0.7) 0.7 — As of December 31, 2022 Gross Amounts Recognized Gross Amounts Offset Gross Amounts Presented Gross Amounts Not Offset Legal Offset Foreign currency forward contracts (in millions) Total assets $ 48.3 $ — $ 48.3 $ (15.2) $ 33.1 Total liabilities (15.2) — (15.2) 15.2 — |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consisted of the following: As of September 30, 2023 As of December 31, 2022 (in millions) Raw materials $ 77.5 $ 38.1 Work-in-process 498.3 260.7 Finished goods 112.9 161.8 Total $ 688.7 $ 460.6 |
Stock-based Compensation Expens
Stock-based Compensation Expense and Share Repurchase Programs | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based Compensation Expense and Share Repurchase Programs | Stock-based Compensation Expense and Share Repurchase Programs Stock-based compensation expense During the three and nine months ended September 30, 2023 and 2022, we recognized the following stock-based compensation expense: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in millions) Stock-based compensation expense by type of award: Restricted stock units (including PSUs) $ 129.1 $ 130.3 $ 358.6 $ 351.5 Stock options 0.2 3.1 4.0 14.9 ESPP share issuances 2.4 1.9 11.8 13.0 Stock-based compensation expense related to inventories (0.8) 0.3 (1.8) 0.4 Total stock-based compensation expense included in “Total costs and expenses” $ 130.9 $ 135.6 $ 372.6 $ 379.8 Stock-based compensation expense by line item: Cost of sales $ 1.7 $ 2.4 $ 5.4 $ 7.0 Research and development expenses 81.1 80.0 231.9 229.9 Selling, general and administrative expenses 48.1 53.2 135.3 142.9 Total stock-based compensation expense included in costs and expenses 130.9 135.6 372.6 379.8 Income tax effect (37.1) (38.8) (109.0) (101.3) Total stock-based compensation expense, net of tax $ 93.8 $ 96.8 $ 263.6 $ 278.5 Share repurchase program In February 2023, our Board of Directors approved a share repurchase program (our “Share Repurchase Program”), pursuant to which we are authorized to repurchase up to $3.0 billion of our common stock. Our Share Repurchase Program does not have an expiration date and can be discontinued at any time. During the nine months ended September 30, 2023, we repurchased 891,060 shares of our common stock under our Share Repurchase Program for an aggregate of $284.1 million. As of September 30, 2023, a total of $2.7 billion remained authorized for future repurchases. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes We are subject to U.S. federal, state, and foreign income taxes. During the three and nine months ended September 30, 2023 and 2022, we recorded the following provisions for income taxes and effective tax rates as compared to our income before provision for income taxes: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in millions, except percentages) Income before provision for income taxes $ 1,179.2 $ 1,176.4 $ 3,232.2 $ 3,155.6 Provision for income taxes $ 143.9 $ 245.9 $ 581.4 $ 652.5 Effective tax rate 12.2 % 20.9 % 18.0 % 20.7 % Our effective tax rate for each of the three and nine months ended September 30, 2023 was lower than the U.S. statutory rate primarily due to a benefit from a research and development tax credit study that was completed in the third quarter of 2023 and excess tax benefits related to stock-based compensation, partially offset by changes in uncertain tax positions. Our effective tax rate was similar to the U.S. statutory rate for each of the three and nine months ended September 30, 2022. We have reviewed the tax positions taken, or to be taken, in our tax returns for all tax years currently open to examination by a taxing authority. As of September 30, 2023 and December 31, 2022, we had $245.4 million and $208.5 million, respectively, of net unrecognized tax benefits, which would affect our tax rate if recognized. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies 2022 Credit Facility In July 2022, Vertex and certain of its subsidiaries entered into a $500.0 million unsecured revolving facility (the “Credit Agreement”) with Bank of America, N.A., as administrative agent and the lenders referred to therein (the “Lenders”), which matures on July 1, 2027. The Credit Agreement was not drawn upon at closing and we have not drawn upon it to date. Amounts drawn pursuant to the Credit Agreement, if any, will be used for general corporate purposes. Subject to satisfaction of certain conditions, we may request that the borrowing capacity for the Credit Agreement be increased by an additional $500.0 million. Additionally, the Credit Agreement provides a sublimit of $100.0 million for letters of credit. Any amounts borrowed under the Credit Agreement will bear interest, at our option, at either a base rate or a Secured Overnight Financing Rate (“SOFR”), in each case plus an applicable margin. Under the Credit Agreement, the applicable margins on base rate loans range from 0.000% to 0.500% and the applicable margins on SOFR loans range from 1.000% to 1.500%, in each case based on our consolidated leverage ratio (the ratio of our total consolidated funded indebtedness to our consolidated EBITDA for the most recently completed four fiscal quarter period). Any amounts borrowed pursuant to the Credit Agreement are guaranteed by certain of our existing and future domestic subsidiaries, subject to certain exceptions. The Credit Agreement contains customary representations and warranties and affirmative and negative covenants, including a financial covenant to maintain subject to certain limited exceptions, a consolidated leverage ratio of 3.50 to 1.00, subject to an increase to 4.00 to 1.00 following a material acquisition. As of September 30, 2023, we were in compliance with the covenants described above. The Credit Agreement also contains customary events of default. In the case of a continuing event of default, the administrative agent would be entitled to exercise various remedies, including the acceleration of amounts due under outstanding loans. Direct costs related to the Credit Agreement are recorded over its term and were not material to our financial statements. Guaranties and Indemnifications As permitted under Massachusetts law, our Articles of Organization and By-laws provide that we will indemnify certain of our officers and directors for certain claims asserted against them in connection with their service as an officer or director. The maximum potential amount of future payments that we could be required to make under these indemnification provisions is unlimited. However, we have purchased directors’ and officers’ liability insurance policies that could reduce our monetary exposure and enable us to recover a portion of any future amounts paid. No indemnification claims currently are outstanding, and we believe the estimated fair value of these indemnification arrangements is minimal. We customarily agree in the ordinary course of our business to indemnification provisions in agreements with clinical trial investigators and sites in our product development programs, sponsored research agreements with academic and not-for-profit institutions, various comparable agreements involving parties performing services for us, and our real estate leases. We also customarily agree to certain indemnification provisions in our drug discovery, development and commercialization collaboration agreements. With respect to our clinical trials and sponsored research agreements, these indemnification provisions typically apply to any claim asserted against the investigator or the investigator’s institution relating to personal injury or property damage, violations of law or certain breaches of our contractual obligations arising out of the research or clinical testing of our compounds or product candidates. With respect to lease agreements, the indemnification provisions typically apply to claims asserted against the landlord relating to personal injury or property damage caused by us, to violations of law by us or to certain breaches of our contractual obligations. The indemnification provisions appearing in our collaboration agreements are similar to those for the other agreements discussed above, but in addition provide some limited indemnification for our collaborator in the event of third-party claims alleging infringement of intellectual property rights. In each of the cases above, the indemnification obligation generally survives the termination of the agreement for some extended period, although we believe the obligation typically has the most relevance during the contract term and for a short period of time thereafter. The maximum potential amount of future payments that we could be required to make under these provisions is generally unlimited. We have purchased insurance policies covering personal injury, property damage and general liability that reduce our exposure for indemnification and would enable us in many cases to recover all or a portion of any future amounts paid. We have never paid any material amounts to defend lawsuits or settle claims related to these indemnification provisions. Accordingly, we believe the estimated fair value of these indemnification arrangements is minimal. Other Contingencies We have certain contingent liabilities that arise in the ordinary course of our business activities. We accrue for such contingent liabilities when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated. Other than our contingent consideration liabilities discussed in Note E, “Fair Value Measurements,” there were no material contingent liabilities accrued as of September 30, 2023 or December 31, 2022. |
Additional Cash Flow Informatio
Additional Cash Flow Information | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Additional Cash Flow Information | Additional Cash Flow Information The cash, cash equivalents and restricted cash at the beginning and ending of each period presented in our condensed consolidated statements of cash flows consisted of the following: Nine Months Ended September 30, 2023 2022 Beginning of period End of period Beginning of period End of period (in millions) Cash and cash equivalents $ 10,504.0 $ 11,110.2 $ 6,795.0 $ 9,171.5 Prepaid expenses and other current assets 8.0 6.4 5.1 5.5 Cash, cash equivalents and restricted cash per condensed consolidated statement of cash flows $ 10,512.0 $ 11,116.6 $ 6,800.1 $ 9,177.0 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Pay vs Performance Disclosure | ||||
Net income | $ 1,035.3 | $ 930.5 | $ 2,650.8 | $ 2,503.1 |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 shares | Sep. 30, 2023 shares | |
Trading Arrangements, by Individual | ||
Material Terms of Trading Arrangement | The following table describes the written plans for the sale of our securities adopted by our executive officers and directors during the third quarter of 2023, each of which is intended to satisfy the affirmative defense conditions of Rule 10b5-1 (each, a “Trading Plan”). Name and Title Date of Adoption of Trading Plan Scheduled Expiration Date of Trading Plan (1) Maximum Shares Subject to Trading Plan E. Morrow “Morrey” Atkinson III EVP, Chief Technical Operations Officer, Head of Biopharmaceutical Sciences and Manufacturing Operations 8/22/2023 4/30/2024 9,224 (2) Reshma Kewalramani President, Chief Executive Officer and Director 8/11/2023 8/15/2024 27,330 Jeffrey M. Leiden Executive Chairman 8/4/2023 5/15/2025 40,454 (2) Bastiano Sanna EVP, Chief of Cell and Genetic Therapies 8/25/2023 8/9/2024 32,833 (2) Charles F. Wagner, Jr. EVP, Chief Financial Officer 8/18/2023 8/9/2024 6,000 (1) A Trading Plan may expire on an earlier date if all contemplated transactions are completed before such Trading Plan’s expiration date, upon termination by broker or the holder of the Trading Plan, or as otherwise provided in the Trading Plan. | |
Non-Rule 10b5-1 Arrangement Adopted | false | |
Rule 10b5-1 Arrangement Terminated | false | |
Non-Rule 10b5-1 Arrangement Terminated | false | |
E. Morrow "Morrey" Atkinson III [Member] | ||
Trading Arrangements, by Individual | ||
Name | E. Morrow “Morrey” Atkinson III | |
Title | EVP, Chief Technical Operations Officer, Head of Biopharmaceutical Sciences and Manufacturing Operations | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | 8/22/2023 | |
Arrangement Duration | 252 days | |
Aggregate Available | 9,224 | 9,224 |
Reshma Kewalramani [Member] | ||
Trading Arrangements, by Individual | ||
Name | Reshma Kewalramani | |
Title | President, Chief Executive Officer and Director | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | 8/11/2023 | |
Arrangement Duration | 370 days | |
Aggregate Available | 27,330 | 27,330 |
Jeffrey M. Leiden [Member] | ||
Trading Arrangements, by Individual | ||
Name | Jeffrey M. Leiden | |
Title | Executive Chairman | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | 8/4/2023 | |
Arrangement Duration | 650 days | |
Aggregate Available | 40,454 | 40,454 |
Bastiano Sanna [Member] | ||
Trading Arrangements, by Individual | ||
Name | Bastiano Sanna | |
Title | EVP, Chief of Cell and Genetic Therapies | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | 8/25/2023 | |
Arrangement Duration | 350 days | |
Aggregate Available | 32,833 | 32,833 |
Charles F. Wagner, Jr. [Member] | ||
Trading Arrangements, by Individual | ||
Name | Charles F. Wagner, Jr. | |
Title | EVP, Chief Financial Officer | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | 8/18/2023 | |
Arrangement Duration | 357 days | |
Aggregate Available | 6,000 | 6,000 |
Basis of Presentation and Acc_2
Basis of Presentation and Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements are unaudited and have been prepared by Vertex Pharmaceuticals Incorporated (“Vertex,” “we,” “us” or “our”) in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The condensed consolidated financial statements reflect the operations of Vertex and our wholly-owned subsidiaries. All material intercompany balances and transactions have been eliminated. We have reclassified certain items from the prior year’s condensed consolidated balance sheet to conform to the current year’s presentation. We operate in one segment, pharmaceuticals. Certain information and footnote disclosures normally included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (the “2022 Annual Report on Form 10-K”) have been condensed or omitted. These interim financial statements, in the opinion of management, reflect all normal recurring adjustments necessary for a fair presentation of the financial position and results of income for the interim periods ended September 30, 2023 and 2022. |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in accordance with U.S. GAAP requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of our condensed consolidated financial statements, and the amounts of revenues and expenses during the reported periods. We base our estimates on historical experience and various other assumptions, including in certain circumstances future projections that we believe to be reasonable under the circumstances. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known. |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Disaggregation of Revenue | “Product revenues, net” consisted of the following: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in millions) TRIKAFTA/KAFTRIO $ 2,274.3 $ 2,010.5 $ 6,611.4 $ 5,665.3 KALYDECO 112.8 139.4 363.1 417.1 ORKAMBI 63.0 146.2 281.8 399.9 SYMDEKO/SYMKEVI 33.4 38.2 95.2 145.7 Total product revenues, net $ 2,483.5 $ 2,334.3 $ 7,351.5 $ 6,628.0 “Product revenues, net” by geographic region, based on the location of the customer, consisted of the following: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in millions) United States $ 1,554.2 $ 1,455.6 $ 4,465.8 $ 4,238.9 Outside of the United States Europe 766.5 730.5 2,373.7 2,018.3 Other 162.8 148.2 512.0 370.8 Total product revenues outside of the United States 929.3 878.7 2,885.7 2,389.1 Total product revenues, net $ 2,483.5 $ 2,334.3 $ 7,351.5 $ 6,628.0 |
Earnings Per Share (Tables)
Earnings Per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | The following table sets forth the computation of basic and diluted net income per common share for the periods ended: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in millions, except per share amounts) Net income $ 1,035.3 $ 930.5 $ 2,650.8 $ 2,503.1 Basic weighted-average common shares outstanding 258.0 256.5 257.7 255.8 Effect of potentially dilutive securities: Stock options 1.2 1.4 1.2 1.4 Restricted stock units (including PSUs) 1.4 1.6 1.5 1.4 Employee stock purchase program 0.0 0.0 0.0 0.1 Diluted weighted-average common shares outstanding 260.6 259.5 260.4 258.7 Basic net income per common share $ 4.01 $ 3.63 $ 10.29 $ 9.78 Diluted net income per common share $ 3.97 $ 3.59 $ 10.18 $ 9.68 |
Schedule of Potential Gross Common Equivalent Shares | We did not include the securities in the following table in the computation of the diluted net income per common share because the effect would have been anti-dilutive during each period: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in millions) Stock options — — 0.0 0.0 Unvested restricted stock units (including PSUs) — 0.0 0.2 0.2 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets Subject to Fair Value Measurements | The following tables set forth our financial assets and liabilities subject to fair value measurements by level within the fair value hierarchy (and does not include $5.5 billion and $3.1 billion of cash as of September 30, 2023 and December 31, 2022, respectively): As of September 30, 2023 As of December 31, 2022 Total Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 (in millions) Financial instruments carried at fair value (asset positions): Cash equivalents: Money market funds $ 3,753.4 $ 3,753.4 $ — $ — $ 5,162.6 $ 5,162.6 $ — $ — Time deposits 1,550.0 — 1,550.0 — 2,000.0 — 2,000.0 — U.S. Treasury securities 236.8 236.8 — — — — — — Corporate debt securities — — — — 5.8 — 5.8 — Commercial paper 96.5 — 96.5 — 204.5 — 204.5 — Marketable securities: Corporate equity securities 46.4 46.4 — — 116.8 88.8 28.0 — U.S. Treasury securities 408.2 408.2 — — — — — — Government-sponsored enterprise securities 421.0 421.0 — — 127.1 127.1 — — Asset-backed securities 237.8 — 237.8 — — — — — Certificates of deposit 31.7 — 31.7 — — — — — Corporate debt securities 1,214.2 — 1,214.2 — 87.0 — 87.0 — Commercial paper 158.7 — 158.7 — 55.8 — 55.8 — Prepaid expenses and other current assets: Foreign currency forward contracts 37.8 — 37.8 — 47.5 — 47.5 — Other assets: Foreign currency forward contracts 3.4 — 3.4 — 0.8 — 0.8 — Total financial assets $ 8,195.9 $ 4,865.8 $ 3,330.1 $ — $ 7,807.9 $ 5,378.5 $ 2,429.4 $ — Financial instruments carried at fair value (liability positions): Other current liabilities: Foreign currency forward contracts $ (0.7) $ — $ (0.7) $ — $ (14.3) $ — $ (14.3) $ — Contingent consideration (15.0) — — (15.0) (14.6) — — (14.6) Other long-term liabilities: Foreign currency forward contracts — — — — (0.9) — (0.9) — Contingent consideration (112.7) — — (112.7) (114.4) — — (114.4) Total financial liabilities $ (128.4) $ — $ (0.7) $ (127.7) $ (144.2) $ — $ (15.2) $ (129.0) |
Schedule of Fair Value of Our Contingent Consideration Liabilities | The following table represents a rollforward of the fair value of our contingent consideration liabilities: Nine Months Ended September 30, 2023 (in millions) Balance at December 31, 2022 $ 129.0 Decrease in fair value of contingent payments (1.3) Balance at September 30, 2023 $ 127.7 |
Marketable Securities and Equ_2
Marketable Securities and Equity Investments (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Cash Equivalents and Marketable Securities | A summary of our cash equivalents and marketable securities, which are recorded at fair value (and do not include $5.5 billion and $3.1 billion of cash as of September 30, 2023 and December 31, 2022, respectively), is shown below: As of September 30, 2023 As of December 31, 2022 Amortized Cost Gross Gross Fair Value Amortized Cost Gross Gross Fair Value (in millions) Cash equivalents: Money market funds $ 3,753.4 $ — $ — $ 3,753.4 $ 5,162.6 $ — $ — $ 5,162.6 Time deposits 1,550.0 — — 1,550.0 2,000.0 — — 2,000.0 U.S. Treasury securities 236.8 — — 236.8 — — — — Corporate debt securities — — — — 5.8 — — 5.8 Commercial paper 96.5 — — 96.5 204.5 — — 204.5 Total cash equivalents $ 5,636.7 $ — $ — $ 5,636.7 $ 7,372.9 $ — $ — $ 7,372.9 Marketable securities: U.S. Treasury securities $ 414.6 $ 0.1 $ (6.5) $ 408.2 $ — $ — $ — $ — Government-sponsored enterprise securities 422.9 — (1.9) 421.0 127.0 0.2 (0.1) 127.1 Asset-backed securities 239.3 0.0 (1.5) 237.8 — — — — Certificates of deposit 31.7 0.0 — 31.7 — — — — Corporate debt securities 1,228.4 0.0 (14.2) 1,214.2 87.2 — (0.2) 87.0 Commercial paper 158.8 0.0 (0.1) 158.7 55.8 — — 55.8 Total marketable debt securities 2,495.7 0.1 (24.2) 2,471.6 270.0 0.2 (0.3) 269.9 Corporate equity securities 72.1 0.5 (26.2) 46.4 104.4 30.9 (18.5) 116.8 Total marketable securities $ 2,567.8 $ 0.6 $ (50.4) $ 2,518.0 $ 374.4 $ 31.1 $ (18.8) $ 386.7 Available-for-sale debt securities were classified on our condensed consolidated balance sheets at fair value as follows: As of September 30, 2023 As of December 31, 2022 (in millions) Cash and cash equivalents $ 4,086.7 $ 5,372.9 Marketable securities 771.6 157.7 Long-term marketable securities 1,700.0 112.2 Total $ 6,558.3 $ 5,642.8 Available-for-sale debt securities by contractual maturity were as follows: As of September 30, 2023 As of December 31, 2022 (in millions) Matures within one year $ 4,858.3 $ 5,530.6 Matures after one year through five years 1,700.0 112.2 Total $ 6,558.3 $ 5,642.8 |
Schedule of Company's Net Unrealized (Losses) Gains on Corporate Equity Securities | During the three and nine months ended September 30, 2023 and 2022, our net unrealized (losses) gains on corporate equity securities held at the conclusion of each period were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in millions) Net unrealized (losses) gains $ (6.2) $ 16.7 $ (7.1) $ (143.1) |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income (Loss) (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Schedule of Accumulated Other Comprehensive Income (Loss) | The following table summarizes the changes in accumulated other comprehensive income (loss) by component: Unrealized Holding Gains (Losses), Net of Tax Foreign Currency Translation Adjustment On Available-For-Sale Debt Securities On Foreign Currency Forward Contracts Total (in millions) Balance at December 31, 2022 $ (25.0) $ (0.1) $ 25.9 $ 0.8 Other comprehensive income (loss) before reclassifications 9.1 (18.8) 31.8 22.1 Amounts reclassified from accumulated other comprehensive income (loss) — — (25.9) (25.9) Net current period other comprehensive income (loss) 9.1 (18.8) 5.9 (3.8) Balance at September 30, 2023 $ (15.9) $ (18.9) $ 31.8 $ (3.0) Balance at December 31, 2021 $ (13.6) $ (0.5) $ 30.0 $ 15.9 Other comprehensive (loss) income before reclassifications (42.8) (3.6) 230.2 183.8 Amounts reclassified from accumulated other comprehensive income (loss) — — (102.1) (102.1) Net current period other comprehensive (loss) income (42.8) (3.6) 128.1 81.7 Balance at September 30, 2022 $ (56.4) $ (4.1) $ 158.1 $ 97.6 |
Hedging (Tables)
Hedging (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Schedule of Cash Flow Hedging Instruments | The following table summarizes the notional amount in U.S. dollars of our outstanding foreign currency forward contracts designated as cash flow hedges under U.S. GAAP: As of September 30, 2023 As of December 31, 2022 Foreign Currency (in millions) Euro $ 1,343.3 $ 1,497.7 Canadian dollar 192.6 216.3 British pound sterling 191.9 247.4 Australian dollar 136.2 174.9 Swiss Franc 51.7 65.2 Total foreign currency forward contracts $ 1,915.7 $ 2,201.5 |
Schedule of Foreign Exchange Contracts, Condensed Consolidated Statements of Operations | During the three and nine months ended September 30, 2023 and 2022, we recognized the following related to foreign currency forward contracts in our condensed consolidated statements of income: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in millions) Designated as hedging instruments - Reclassified from AOCI Product revenues, net $ 2.8 $ 65.2 $ 33.0 $ 130.3 Not designated as hedging instruments Other (expense) income, net $ (22.0) $ (22.1) $ (17.8) $ (38.9) Total reported in the Condensed Consolidated Statements of Income Product revenues, net $ 2,483.5 $ 2,334.3 $ 7,351.5 $ 6,628.0 Other (expense) income, net $ (15.9) $ 17.2 $ (13.0) $ (133.7) |
Schedule of Foreign Exchange Contracts | The following table summarizes the fair value of our outstanding foreign currency forward contracts designated as cash flow hedges under U.S. GAAP included on our condensed consolidated balance sheets: As of September 30, 2023 Assets Liabilities Classification Fair Value Classification Fair Value (in millions) Prepaid expenses and other current assets $ 37.8 Other current liabilities $ (0.7) Other assets 3.4 Other long-term liabilities — Total assets $ 41.2 Total liabilities $ (0.7) As of December 31, 2022 Assets Liabilities Classification Fair Value Classification Fair Value (in millions) Prepaid expenses and other current assets $ 47.5 Other current liabilities $ (14.3) Other assets 0.8 Other long-term liabilities (0.9) Total assets $ 48.3 Total liabilities $ (15.2) |
Schedule of Offsetting Assets | The following table summarizes the potential effect of offsetting derivatives by type of financial instrument designated as cash flow hedges under U.S. GAAP on our condensed consolidated balance sheets: As of September 30, 2023 Gross Amounts Recognized Gross Amounts Offset Gross Amounts Presented Gross Amounts Not Offset Legal Offset Foreign currency forward contracts (in millions) Total assets $ 41.2 $ — $ 41.2 $ (0.7) $ 40.5 Total liabilities (0.7) — (0.7) 0.7 — As of December 31, 2022 Gross Amounts Recognized Gross Amounts Offset Gross Amounts Presented Gross Amounts Not Offset Legal Offset Foreign currency forward contracts (in millions) Total assets $ 48.3 $ — $ 48.3 $ (15.2) $ 33.1 Total liabilities (15.2) — (15.2) 15.2 — |
Schedule of Offsetting Liabilities | The following table summarizes the potential effect of offsetting derivatives by type of financial instrument designated as cash flow hedges under U.S. GAAP on our condensed consolidated balance sheets: As of September 30, 2023 Gross Amounts Recognized Gross Amounts Offset Gross Amounts Presented Gross Amounts Not Offset Legal Offset Foreign currency forward contracts (in millions) Total assets $ 41.2 $ — $ 41.2 $ (0.7) $ 40.5 Total liabilities (0.7) — (0.7) 0.7 — As of December 31, 2022 Gross Amounts Recognized Gross Amounts Offset Gross Amounts Presented Gross Amounts Not Offset Legal Offset Foreign currency forward contracts (in millions) Total assets $ 48.3 $ — $ 48.3 $ (15.2) $ 33.1 Total liabilities (15.2) — (15.2) 15.2 — |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories by Type | Inventories consisted of the following: As of September 30, 2023 As of December 31, 2022 (in millions) Raw materials $ 77.5 $ 38.1 Work-in-process 498.3 260.7 Finished goods 112.9 161.8 Total $ 688.7 $ 460.6 |
Stock-based Compensation Expe_2
Stock-based Compensation Expense and Share Repurchase Programs (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock-based Compensation Expense by Line Item | During the three and nine months ended September 30, 2023 and 2022, we recognized the following stock-based compensation expense: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in millions) Stock-based compensation expense by type of award: Restricted stock units (including PSUs) $ 129.1 $ 130.3 $ 358.6 $ 351.5 Stock options 0.2 3.1 4.0 14.9 ESPP share issuances 2.4 1.9 11.8 13.0 Stock-based compensation expense related to inventories (0.8) 0.3 (1.8) 0.4 Total stock-based compensation expense included in “Total costs and expenses” $ 130.9 $ 135.6 $ 372.6 $ 379.8 Stock-based compensation expense by line item: Cost of sales $ 1.7 $ 2.4 $ 5.4 $ 7.0 Research and development expenses 81.1 80.0 231.9 229.9 Selling, general and administrative expenses 48.1 53.2 135.3 142.9 Total stock-based compensation expense included in costs and expenses 130.9 135.6 372.6 379.8 Income tax effect (37.1) (38.8) (109.0) (101.3) Total stock-based compensation expense, net of tax $ 93.8 $ 96.8 $ 263.6 $ 278.5 |
Income Taxes (Tables)
Income Taxes (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision for (Benefits from) Income Taxes and Effective Tax rates | During the three and nine months ended September 30, 2023 and 2022, we recorded the following provisions for income taxes and effective tax rates as compared to our income before provision for income taxes: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in millions, except percentages) Income before provision for income taxes $ 1,179.2 $ 1,176.4 $ 3,232.2 $ 3,155.6 Provision for income taxes $ 143.9 $ 245.9 $ 581.4 $ 652.5 Effective tax rate 12.2 % 20.9 % 18.0 % 20.7 % |
Additional Cash Flow Informat_2
Additional Cash Flow Information (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Additional Cash Flow Information | The cash, cash equivalents and restricted cash at the beginning and ending of each period presented in our condensed consolidated statements of cash flows consisted of the following: Nine Months Ended September 30, 2023 2022 Beginning of period End of period Beginning of period End of period (in millions) Cash and cash equivalents $ 10,504.0 $ 11,110.2 $ 6,795.0 $ 9,171.5 Prepaid expenses and other current assets 8.0 6.4 5.1 5.5 Cash, cash equivalents and restricted cash per condensed consolidated statement of cash flows $ 10,512.0 $ 11,116.6 $ 6,800.1 $ 9,177.0 |
Basis of Presentation and Acc_3
Basis of Presentation and Accounting Policies (Details) | 9 Months Ended |
Sep. 30, 2023 segment | |
Accounting Policies [Abstract] | |
Number of operating segments | 1 |
Revenue Recognition - Disaggreg
Revenue Recognition - Disaggregation of Revenue (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Disaggregation of Revenue [Line Items] | ||||
Product revenues, net | $ 2,483.5 | $ 2,334.3 | $ 7,351.5 | $ 6,628 |
United States | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues, net | 1,554.2 | 1,455.6 | 4,465.8 | 4,238.9 |
Total product revenues outside of the United States | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues, net | 929.3 | 878.7 | 2,885.7 | 2,389.1 |
Europe | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues, net | 766.5 | 730.5 | 2,373.7 | 2,018.3 |
Other | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues, net | 162.8 | 148.2 | 512 | 370.8 |
TRIKAFTA/KAFTRIO | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues, net | 2,274.3 | 2,010.5 | 6,611.4 | 5,665.3 |
KALYDECO | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues, net | 112.8 | 139.4 | 363.1 | 417.1 |
ORKAMBI | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues, net | 63 | 146.2 | 281.8 | 399.9 |
SYMDEKO/SYMKEVI | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues, net | $ 33.4 | $ 38.2 | $ 95.2 | $ 145.7 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Details) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Revenue from Contract with Customer [Abstract] | ||
Contract liabilities | $ 157.1 | $ 159.6 |
Acquired In-Process Research _2
Acquired In-Process Research and Development and Other Arrangements - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) | Feb. 28, 2023 USD ($) | Jul. 31, 2022 USD ($) | May 31, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2019 USD ($) target | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Acquired in-process research and development expenses | $ 51,700,000 | $ 29,000,000 | $ 509,300,000 | $ 92,900,000 | |||||||
Selling, general and administrative expenses | 263,800,000 | 246,800,000 | 767,500,000 | 677,300,000 | |||||||
Septerna, Inc | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Asset acquisition, consideration transferred | $ 47,500,000 | ||||||||||
Catalyst Biosciences | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Asset acquisition, consideration transferred | $ 60,000,000 | ||||||||||
CRISPR Therapeutics | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Collaborative arrangement, right to exclusively license, number of targets | target | 3 | ||||||||||
Collaborative arrangement, development and regulatory potential milestone payments maximum | $ 410,000,000 | ||||||||||
CRISPR JDCA | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Collaborative arrangement, development and regulatory potential milestone payments maximum | $ 200,000,000 | ||||||||||
Allocation of net profits and net losses, percent | 60% | ||||||||||
Research and development expenses | 74,900,000 | 45,500,000 | 193,200,000 | 120,600,000 | |||||||
Selling, general and administrative expenses | 26,000,000 | $ 13,500,000 | 66,100,000 | $ 35,300,000 | |||||||
CRISPR JDCA | CRISPR | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Allocation of net profits and net losses, percent | 40% | ||||||||||
CRISPR T1D | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Acquired in-process research and development expenses | 170,000,000 | ||||||||||
Collaborative arrangement, development and regulatory potential milestone payments maximum | $ 160,000,000 | ||||||||||
Up-front payment | $ 100,000,000 | ||||||||||
Milestone payment | $ 70,000,000 | ||||||||||
Entrada Therapeutics | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Collaborative arrangement, development and regulatory potential milestone payments maximum | $ 485,000,000 | ||||||||||
Up-front payment | 225,100,000 | ||||||||||
Purchase of common stock | $ 24,900,000 | ||||||||||
Verve | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Up-front payment | $ 25,000,000 | ||||||||||
Purchase of common stock | $ 35,000,000 |
Earnings Per Share - Schedule o
Earnings Per Share - Schedule of Computation (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||||
Net income | $ 1,035.3 | $ 930.5 | $ 2,650.8 | $ 2,503.1 |
Basic weighted-average common shares outstanding (in shares) | 258 | 256.5 | 257.7 | 255.8 |
Effect of potentially dilutive securities: | ||||
Employee stock purchase program (in shares) | 0 | 0 | 0 | 0.1 |
Diluted weighted-average common shares outstanding (in shares) | 260.6 | 259.5 | 260.4 | 258.7 |
Basic net income per common share (in dollars per share) | $ 4.01 | $ 3.63 | $ 10.29 | $ 9.78 |
Diluted net income per common share (in dollars per share) | $ 3.97 | $ 3.59 | $ 10.18 | $ 9.68 |
Stock options | ||||
Effect of potentially dilutive securities: | ||||
Share-based payment arrangements (in shares) | 1.2 | 1.4 | 1.2 | 1.4 |
Restricted stock units (including PSUs) | ||||
Effect of potentially dilutive securities: | ||||
Share-based payment arrangements (in shares) | 1.4 | 1.6 | 1.5 | 1.4 |
Earnings Per Share - Anti-dilut
Earnings Per Share - Anti-dilutive Securities (Details) - shares shares in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Stock options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 0 | 0 | 0 | 0 |
Unvested restricted stock units (including PSUs) | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 0 | 0 | 0.2 | 0.2 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) $ in Millions | Sep. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash | $ 5,500 | $ 3,100 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Remaining milestone payment | $ 678.3 | |
Level 3 | Minimum | Discount Rate | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent consideration, measurement input (as a percent) | 0.055 | |
Level 3 | Maximum | Discount Rate | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent consideration, measurement input (as a percent) | 0.065 | |
Corporate equity securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments with restrictions | $ 25.5 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Assets and Liabilities Subject to Fair Value Measurements (Details) - Recurring Basis - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Financial instruments carried at fair value (asset positions): | ||
Prepaid expenses and other current assets, foreign currency forward contracts | $ 37.8 | $ 47.5 |
Other assets, foreign currency forward contracts | 3.4 | 0.8 |
Total financial assets | 8,195.9 | 7,807.9 |
Financial instruments carried at fair value (liability positions): | ||
Other current liabilities, foreign currency forward contracts | (0.7) | (14.3) |
Other current liabilities, contingent consideration | (15) | (14.6) |
Other long-term liabilities, foreign currency forward contracts | 0 | (0.9) |
Contingent consideration | (112.7) | (114.4) |
Total financial liabilities | (128.4) | (144.2) |
Level 1 | ||
Financial instruments carried at fair value (asset positions): | ||
Prepaid expenses and other current assets, foreign currency forward contracts | 0 | 0 |
Other assets, foreign currency forward contracts | 0 | 0 |
Total financial assets | 4,865.8 | 5,378.5 |
Financial instruments carried at fair value (liability positions): | ||
Other current liabilities, foreign currency forward contracts | 0 | 0 |
Other current liabilities, contingent consideration | 0 | 0 |
Other long-term liabilities, foreign currency forward contracts | 0 | 0 |
Contingent consideration | 0 | 0 |
Total financial liabilities | 0 | 0 |
Level 2 | ||
Financial instruments carried at fair value (asset positions): | ||
Prepaid expenses and other current assets, foreign currency forward contracts | 37.8 | 47.5 |
Other assets, foreign currency forward contracts | 3.4 | 0.8 |
Total financial assets | 3,330.1 | 2,429.4 |
Financial instruments carried at fair value (liability positions): | ||
Other current liabilities, foreign currency forward contracts | (0.7) | (14.3) |
Other current liabilities, contingent consideration | 0 | 0 |
Other long-term liabilities, foreign currency forward contracts | 0 | (0.9) |
Contingent consideration | 0 | 0 |
Total financial liabilities | (0.7) | (15.2) |
Level 3 | ||
Financial instruments carried at fair value (asset positions): | ||
Prepaid expenses and other current assets, foreign currency forward contracts | 0 | 0 |
Other assets, foreign currency forward contracts | 0 | 0 |
Total financial assets | 0 | 0 |
Financial instruments carried at fair value (liability positions): | ||
Other current liabilities, foreign currency forward contracts | 0 | 0 |
Other current liabilities, contingent consideration | (15) | (14.6) |
Other long-term liabilities, foreign currency forward contracts | 0 | 0 |
Contingent consideration | (112.7) | (114.4) |
Total financial liabilities | (127.7) | (129) |
Money market funds | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 3,753.4 | 5,162.6 |
Money market funds | Level 1 | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 3,753.4 | 5,162.6 |
Money market funds | Level 2 | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 0 | 0 |
Money market funds | Level 3 | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 0 | 0 |
Time deposits | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 1,550 | 2,000 |
Time deposits | Level 1 | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 0 | 0 |
Time deposits | Level 2 | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 1,550 | 2,000 |
Time deposits | Level 3 | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 0 | 0 |
Corporate equity securities | ||
Financial instruments carried at fair value (asset positions): | ||
Marketable securities: | 46.4 | 116.8 |
Corporate equity securities | Level 1 | ||
Financial instruments carried at fair value (asset positions): | ||
Marketable securities: | 46.4 | 88.8 |
Corporate equity securities | Level 2 | ||
Financial instruments carried at fair value (asset positions): | ||
Marketable securities: | 0 | 28 |
Corporate equity securities | Level 3 | ||
Financial instruments carried at fair value (asset positions): | ||
Marketable securities: | 0 | 0 |
U.S. Treasury securities | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 236.8 | 0 |
Marketable securities: | 408.2 | 0 |
U.S. Treasury securities | Level 1 | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 236.8 | 0 |
Marketable securities: | 408.2 | 0 |
U.S. Treasury securities | Level 2 | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 0 | 0 |
Marketable securities: | 0 | 0 |
U.S. Treasury securities | Level 3 | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 0 | 0 |
Marketable securities: | 0 | 0 |
Government-sponsored enterprise securities | ||
Financial instruments carried at fair value (asset positions): | ||
Marketable securities: | 421 | 127.1 |
Government-sponsored enterprise securities | Level 1 | ||
Financial instruments carried at fair value (asset positions): | ||
Marketable securities: | 421 | 127.1 |
Government-sponsored enterprise securities | Level 2 | ||
Financial instruments carried at fair value (asset positions): | ||
Marketable securities: | 0 | 0 |
Government-sponsored enterprise securities | Level 3 | ||
Financial instruments carried at fair value (asset positions): | ||
Marketable securities: | 0 | 0 |
Asset-backed securities | ||
Financial instruments carried at fair value (asset positions): | ||
Marketable securities: | 237.8 | 0 |
Asset-backed securities | Level 1 | ||
Financial instruments carried at fair value (asset positions): | ||
Marketable securities: | 0 | 0 |
Asset-backed securities | Level 2 | ||
Financial instruments carried at fair value (asset positions): | ||
Marketable securities: | 237.8 | 0 |
Asset-backed securities | Level 3 | ||
Financial instruments carried at fair value (asset positions): | ||
Marketable securities: | 0 | 0 |
Certificates of deposit | ||
Financial instruments carried at fair value (asset positions): | ||
Marketable securities: | 31.7 | 0 |
Certificates of deposit | Level 1 | ||
Financial instruments carried at fair value (asset positions): | ||
Marketable securities: | 0 | 0 |
Certificates of deposit | Level 2 | ||
Financial instruments carried at fair value (asset positions): | ||
Marketable securities: | 31.7 | 0 |
Certificates of deposit | Level 3 | ||
Financial instruments carried at fair value (asset positions): | ||
Marketable securities: | 0 | 0 |
Corporate debt securities | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 0 | 5.8 |
Marketable securities: | 1,214.2 | 87 |
Corporate debt securities | Level 1 | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 0 | 0 |
Marketable securities: | 0 | 0 |
Corporate debt securities | Level 2 | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 0 | 5.8 |
Marketable securities: | 1,214.2 | 87 |
Corporate debt securities | Level 3 | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 0 | 0 |
Marketable securities: | 0 | 0 |
Commercial paper | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 96.5 | 204.5 |
Marketable securities: | 158.7 | 55.8 |
Commercial paper | Level 1 | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 0 | 0 |
Marketable securities: | 0 | 0 |
Commercial paper | Level 2 | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 96.5 | 204.5 |
Marketable securities: | 158.7 | 55.8 |
Commercial paper | Level 3 | ||
Financial instruments carried at fair value (asset positions): | ||
Cash equivalents: | 0 | 0 |
Marketable securities: | $ 0 | $ 0 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value of Contingent Consideration Liabilities (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||||
Beginning balance | $ 129 | |||
Decrease in fair value of contingent payments | $ 1.2 | $ (2.6) | (1.3) | $ (59.3) |
Ending balance | $ 127.7 | $ 127.7 |
Marketable Securities and Equ_3
Marketable Securities and Equity Investments - Additional Information (Details) - USD ($) | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Summary of cash, cash equivalents and marketable securities | |||
Cash | $ 5,500,000,000 | $ 3,100,000,000 | |
Allowance for credit loss for available-for-sale debt securities | 0 | $ 0 | |
Debt securities fair value, unrealized loss position | 2,280,000,000 | ||
Unrealized loss | 24,200,000 | ||
Unrealized loss position for greater than twelve months | 0 | ||
Original cost | 72,100,000 | $ 104,400,000 | |
Publicly Traded Companies Sale | |||
Summary of cash, cash equivalents and marketable securities | |||
Proceeds received | 95,100,000 | $ 0 | |
Original cost | 57,300,000 | ||
Other Assets | |||
Summary of cash, cash equivalents and marketable securities | |||
Equity securities without readily determinable fair value, amount | $ 98,600,000 |
Marketable Securities and Equ_4
Marketable Securities and Equity Investments - Summary of Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Millions | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Cash equivalents: | ||
Amortized Cost | $ 5,636.7 | $ 7,372.9 |
Fair Value | 5,636.7 | 7,372.9 |
Total marketable debt securities | ||
Gross Unrealized Losses | (24.2) | |
Fair Value | 6,558.3 | 5,642.8 |
Corporate equity securities | ||
Amortized Cost | 72.1 | 104.4 |
Gross Unrealized Gains | 0.5 | 30.9 |
Gross Unrealized Losses | (26.2) | (18.5) |
Fair Value | 46.4 | 116.8 |
Amortized Cost | 2,567.8 | 374.4 |
Gross Unrealized Gains | 0.6 | 31.1 |
Gross Unrealized Losses | (50.4) | (18.8) |
Fair Value | 2,518 | 386.7 |
Money market funds | ||
Cash equivalents: | ||
Amortized Cost | 3,753.4 | 5,162.6 |
Fair Value | 3,753.4 | 5,162.6 |
Time deposits | ||
Cash equivalents: | ||
Amortized Cost | 1,550 | 2,000 |
Fair Value | 1,550 | 2,000 |
U.S. Treasury securities | ||
Cash equivalents: | ||
Amortized Cost | 236.8 | 0 |
Fair Value | 236.8 | 0 |
Total marketable debt securities | ||
Amortized Cost | 414.6 | 0 |
Gross Unrealized Gains | 0.1 | 0 |
Gross Unrealized Losses | (6.5) | 0 |
Fair Value | 408.2 | 0 |
Government-sponsored enterprise securities | ||
Total marketable debt securities | ||
Amortized Cost | 422.9 | 127 |
Gross Unrealized Gains | 0 | 0.2 |
Gross Unrealized Losses | (1.9) | (0.1) |
Fair Value | 421 | 127.1 |
Asset-backed securities | ||
Total marketable debt securities | ||
Amortized Cost | 239.3 | 0 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (1.5) | 0 |
Fair Value | 237.8 | 0 |
Certificates of deposit | ||
Total marketable debt securities | ||
Amortized Cost | 31.7 | 0 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 31.7 | 0 |
Corporate debt securities | ||
Cash equivalents: | ||
Amortized Cost | 0 | 5.8 |
Fair Value | 0 | 5.8 |
Total marketable debt securities | ||
Amortized Cost | 1,228.4 | 87.2 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (14.2) | (0.2) |
Fair Value | 1,214.2 | 87 |
Commercial paper | ||
Cash equivalents: | ||
Amortized Cost | 96.5 | 204.5 |
Fair Value | 96.5 | 204.5 |
Commercial paper | ||
Total marketable debt securities | ||
Amortized Cost | 158.8 | 55.8 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (0.1) | 0 |
Fair Value | 158.7 | 55.8 |
Total marketable debt securities | ||
Total marketable debt securities | ||
Amortized Cost | 2,495.7 | 270 |
Gross Unrealized Gains | 0.1 | 0.2 |
Gross Unrealized Losses | (24.2) | (0.3) |
Fair Value | $ 2,471.6 | $ 269.9 |
Marketable Securities and Equ_5
Marketable Securities and Equity Investments - Available-for-Sale Debt Securities at Fair Value (Details) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Debt Securities, Available-for-sale [Line Items] | ||
Debt securities | $ 6,558.3 | $ 5,642.8 |
Cash and cash equivalents | ||
Debt Securities, Available-for-sale [Line Items] | ||
Debt securities | 4,086.7 | 5,372.9 |
Marketable securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Debt securities | 771.6 | 157.7 |
Long-term marketable securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Debt securities | $ 1,700 | $ 112.2 |
Marketable Securities and Equ_6
Marketable Securities and Equity Investments - Available-for-Sale Debt Securities by Contractual Maturity (Details) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Investments, Debt and Equity Securities [Abstract] | ||
Matures within one year | $ 4,858.3 | $ 5,530.6 |
Matures after one year through five years | 1,700 | 112.2 |
Total | $ 6,558.3 | $ 5,642.8 |
Marketable Securities and Equ_7
Marketable Securities and Equity Investments - Net Unrealized Gains (Losses) (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | ||||
Net unrealized (losses) gains | $ (6.2) | $ 16.7 | $ (7.1) | $ (143.1) |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Income (Loss) (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||
Beginning balance | $ 15,470.2 | $ 11,933.5 | $ 13,912.7 | $ 10,100 |
Other comprehensive income (loss) before reclassifications | 22.1 | 183.8 | ||
Amounts reclassified from accumulated other comprehensive income (loss) | (25.9) | (102.1) | ||
Total other comprehensive income (loss) | 36.8 | 40.1 | (3.8) | 81.7 |
Ending balance | 16,512.8 | 13,029.6 | 16,512.8 | 13,029.6 |
Total | ||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||
Beginning balance | (39.8) | 57.5 | 0.8 | 15.9 |
Total other comprehensive income (loss) | 36.8 | 40.1 | (3.8) | 81.7 |
Ending balance | (3) | 97.6 | (3) | 97.6 |
Foreign Currency Translation Adjustment | ||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||
Beginning balance | (25) | (13.6) | ||
Other comprehensive income (loss) before reclassifications | 9.1 | (42.8) | ||
Amounts reclassified from accumulated other comprehensive income (loss) | 0 | 0 | ||
Total other comprehensive income (loss) | 9.1 | (42.8) | ||
Ending balance | (15.9) | (56.4) | (15.9) | (56.4) |
On Available-For-Sale Debt Securities | ||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||
Beginning balance | (0.1) | (0.5) | ||
Other comprehensive income (loss) before reclassifications | (18.8) | (3.6) | ||
Amounts reclassified from accumulated other comprehensive income (loss) | 0 | 0 | ||
Total other comprehensive income (loss) | (18.8) | (3.6) | ||
Ending balance | (18.9) | (4.1) | (18.9) | (4.1) |
On Foreign Currency Forward Contracts | ||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||
Beginning balance | 25.9 | 30 | ||
Other comprehensive income (loss) before reclassifications | 31.8 | 230.2 | ||
Amounts reclassified from accumulated other comprehensive income (loss) | (25.9) | (102.1) | ||
Total other comprehensive income (loss) | 5.9 | 128.1 | ||
Ending balance | $ 31.8 | $ 158.1 | $ 31.8 | $ 158.1 |
Hedging - Additional Informatio
Hedging - Additional Information (Details) - Foreign currency forward contracts $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Not Designated as Hedging Instrument | |
Derivative [Line Items] | |
Derivative term | 1 month |
Notional amount of foreign currency forward contract | $ 922.8 |
Cash Flow Hedging | Minimum | |
Derivative [Line Items] | |
Derivative term | 1 month |
Cash Flow Hedging | Maximum | |
Derivative [Line Items] | |
Derivative term | 18 months |
Hedging - Notional Amount (Deta
Hedging - Notional Amount (Details) - Foreign currency forward contracts - Designated as Hedging Instruments - Cash Flow Hedging - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Derivative [Line Items] | ||
Notional amount of foreign currency forward contract | $ 1,915.7 | $ 2,201.5 |
Euro | ||
Derivative [Line Items] | ||
Notional amount of foreign currency forward contract | 1,343.3 | 1,497.7 |
Canadian dollar | ||
Derivative [Line Items] | ||
Notional amount of foreign currency forward contract | 192.6 | 216.3 |
British pound sterling | ||
Derivative [Line Items] | ||
Notional amount of foreign currency forward contract | 191.9 | 247.4 |
Australian dollar | ||
Derivative [Line Items] | ||
Notional amount of foreign currency forward contract | 136.2 | 174.9 |
Swiss Franc | ||
Derivative [Line Items] | ||
Notional amount of foreign currency forward contract | $ 51.7 | $ 65.2 |
Hedging - Cash Flow Hedging Ins
Hedging - Cash Flow Hedging Instruments (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Product revenues, net | $ 2,483.5 | $ 2,334.3 | $ 7,351.5 | $ 6,628 |
Other (expense) income, net | (15.9) | 17.2 | (13) | (133.7) |
Foreign Currency Forward Contract | Reclassification out of Accumulated Other Comprehensive Income | Foreign currency forward contracts | Designated as hedging instruments | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Product revenues, net | 2.8 | 65.2 | 33 | 130.3 |
Foreign Currency Forward Contract | Reclassification out of Accumulated Other Comprehensive Income | Foreign currency forward contracts | Not designated as hedging instruments | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Other (expense) income, net | $ (22) | $ (22.1) | $ (17.8) | $ (38.9) |
Hedging - Derivative Fair Value
Hedging - Derivative Fair Value (Details) - Designated as Hedging Instruments - Foreign currency forward contracts - Cash Flow Hedging - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Derivative [Line Items] | ||
Total assets | $ 41.2 | $ 48.3 |
Total liabilities | (0.7) | (15.2) |
Prepaid expenses and other current assets | ||
Derivative [Line Items] | ||
Total assets | 37.8 | 47.5 |
Other assets | ||
Derivative [Line Items] | ||
Total assets | 3.4 | 0.8 |
Other current liabilities | ||
Derivative [Line Items] | ||
Total liabilities | (0.7) | (14.3) |
Other long-term liabilities | ||
Derivative [Line Items] | ||
Total liabilities | $ 0 | $ (0.9) |
Hedging - Offsetting Derivative
Hedging - Offsetting Derivatives (Details) - Cash Flow Hedging - Designated as Hedging Instruments - Foreign currency forward contracts - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Offsetting Derivative Assets [Abstract] | ||
Gross Amounts Recognized | $ 41.2 | $ 48.3 |
Gross Amounts Offset | 0 | 0 |
Gross Amounts Presented | 41.2 | 48.3 |
Gross Amounts Not Offset | (0.7) | (15.2) |
Legal Offset | 40.5 | 33.1 |
Offsetting Derivative Liabilities [Abstract] | ||
Gross Amounts Recognized | (0.7) | (15.2) |
Gross Amounts Offset | 0 | 0 |
Gross Amounts Presented | (0.7) | (15.2) |
Gross Amounts Not Offset | 0.7 | 15.2 |
Legal Offset | $ 0 | $ 0 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 77.5 | $ 38.1 |
Work-in-process | 498.3 | 260.7 |
Finished goods | 112.9 | 161.8 |
Total | $ 688.7 | $ 460.6 |
Stock-based Compensation Expe_3
Stock-based Compensation Expense and Share Repurchase Programs - Stock-based Compensation Expense (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Stock-based compensation expense: | ||||
Total stock-based compensation expense included in costs and expenses | $ 130.9 | $ 135.6 | $ 372.6 | $ 379.8 |
Stock-based compensation expense related to inventories | (0.8) | 0.3 | (1.8) | 0.4 |
Total stock-based compensation expense included in “Total costs and expenses” | 130.9 | 135.6 | 372.6 | 379.8 |
Income tax effect | (37.1) | (38.8) | (109) | (101.3) |
Total stock-based compensation expense, net of tax | 93.8 | 96.8 | 263.6 | 278.5 |
Cost of sales | ||||
Stock-based compensation expense: | ||||
Total stock-based compensation expense included in costs and expenses | 1.7 | 2.4 | 5.4 | 7 |
Research and development expenses | ||||
Stock-based compensation expense: | ||||
Total stock-based compensation expense included in costs and expenses | 81.1 | 80 | 231.9 | 229.9 |
Selling, general and administrative expenses | ||||
Stock-based compensation expense: | ||||
Total stock-based compensation expense included in costs and expenses | 48.1 | 53.2 | 135.3 | 142.9 |
Restricted stock units (including PSUs) | ||||
Stock-based compensation expense: | ||||
Total stock-based compensation expense included in costs and expenses | 129.1 | 130.3 | 358.6 | 351.5 |
Stock options | ||||
Stock-based compensation expense: | ||||
Total stock-based compensation expense included in costs and expenses | 0.2 | 3.1 | 4 | 14.9 |
ESPP share issuances | ||||
Stock-based compensation expense: | ||||
Total stock-based compensation expense included in costs and expenses | $ 2.4 | $ 1.9 | $ 11.8 | $ 13 |
Stock-based Compensation Expe_4
Stock-based Compensation Expense and Share Repurchase Programs - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2023 | Feb. 28, 2023 | |
Share-Based Payment Arrangement [Abstract] | |||
Number of shares authorized to be repurchased | $ 3,000,000,000 | ||
Shares repurchased (in shares) | 891,060 | ||
Value of shares repurchased | $ 123,000,000 | $ 284,100,000 | |
Stock repurchase program, remaining amount | $ 2,700,000,000 | $ 2,700,000,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |||||
Income before provision for income taxes | $ 1,179.2 | $ 1,176.4 | $ 3,232.2 | $ 3,155.6 | |
Provision for income taxes | $ 143.9 | $ 245.9 | $ 581.4 | $ 652.5 | |
Effective tax rate | 12.20% | 20.90% | 18% | 20.70% | |
Net unrecognized tax benefits which would affect the tax rate if recognized | $ 245.4 | $ 245.4 | $ 208.5 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | 1 Months Ended | ||
Jul. 31, 2022 | Sep. 30, 2023 | Dec. 31, 2022 | |
Line of Credit Facility [Line Items] | |||
Indemnification claims | $ 0 | ||
Contingent liabilities | $ 0 | $ 0 | |
SOFR Loan | Minimum | |||
Line of Credit Facility [Line Items] | |||
Basis spread on variable rate (as a percent) | 1% | ||
SOFR Loan | Maximum | |||
Line of Credit Facility [Line Items] | |||
Basis spread on variable rate (as a percent) | 1.50% | ||
Revolving Credit Facility | |||
Line of Credit Facility [Line Items] | |||
Line of credit facility, maximum borrowing capacity | $ 500,000,000 | ||
Line of credit facility additional borrowing capacity | $ 500,000,000 | ||
Debt covenant, consolidated leverage ratio | 3.50 | ||
Debt covenant, increase in consolidated leverage ratio | 4 | ||
Revolving Credit Facility | Base Rate | Minimum | |||
Line of Credit Facility [Line Items] | |||
Basis spread on variable rate (as a percent) | 0% | ||
Revolving Credit Facility | Base Rate | Maximum | |||
Line of Credit Facility [Line Items] | |||
Basis spread on variable rate (as a percent) | 0.50% | ||
Letters of Credit | |||
Line of Credit Facility [Line Items] | |||
Line of credit facility, maximum borrowing capacity | $ 100,000,000 |
Additional Cash Flow Informat_3
Additional Cash Flow Information (Details) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Cash and cash equivalents | $ 11,110.2 | $ 10,504 | $ 9,171.5 | $ 6,795 |
Prepaid expenses and other current assets | 6.4 | 8 | 5.5 | 5.1 |
Cash, cash equivalents and restricted cash per condensed consolidated statement of cash flows | $ 11,116.6 | $ 10,512 | $ 9,177 | $ 6,800.1 |