Item 1. Financial Statements
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Item 1. Financial Statements
VERTEX PHARMACEUTICALS INCORPORATED
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
| Revenues: | |||||||||||||||||||||||
| Product revenues, net | $ | 1,984,164 | $ | 1,536,271 | $ | 5,500,839 | $ | 4,575,863 | |||||||||||||||
| Other revenues | — | 2,000 | 1,000 | 2,000 | |||||||||||||||||||
| Total revenues | 1,984,164 | 1,538,271 | 5,501,839 | 4,577,863 | |||||||||||||||||||
| Costs and expenses: | |||||||||||||||||||||||
| Cost of sales | 236,512 | 186,182 | 656,813 | 533,199 | |||||||||||||||||||
| Research and development expenses | 493,751 | 493,497 | 2,356,814 | 1,362,953 | |||||||||||||||||||
| Selling, general and administrative expenses | 198,189 | 184,551 | 584,935 | 558,613 | |||||||||||||||||||
| Change in fair value of contingent consideration | 1,200 | 1,800 | (1,100) | 12,600 | |||||||||||||||||||
| Total costs and expenses | 929,652 | 866,030 | 3,597,462 | 2,467,365 | |||||||||||||||||||
| Income from operations | 1,054,512 | 672,241 | 1,904,377 | 2,110,498 | |||||||||||||||||||
| Interest income | 1,116 | 3,100 | 3,714 | 19,919 | |||||||||||||||||||
| Interest expense | (15,255) | (13,856) | (46,411) | (41,863) | |||||||||||||||||||
| Other income (expense), net | 42,368 | 84,386 | (2,234) | 139,621 | |||||||||||||||||||
| Income before provision for income taxes | 1,082,741 | 745,871 | 1,859,446 | 2,228,175 | |||||||||||||||||||
| Provision for income taxes | 230,813 | 78,437 | 287,456 | 120,718 | |||||||||||||||||||
| Net income | $ | 851,928 | $ | 667,434 | $ | 1,571,990 | $ | 2,107,457 | |||||||||||||||
| Net income per common share: | |||||||||||||||||||||||
| Basic | $ | 3.30 | $ | 2.56 | $ | 6.08 | $ | 8.10 | |||||||||||||||
| Diluted | $ | 3.28 | $ | 2.53 | $ | 6.03 | $ | 7.98 | |||||||||||||||
| Shares used in per share calculations: | |||||||||||||||||||||||
| Basic | 257,876 | 260,392 | 258,740 | 260,313 | |||||||||||||||||||
| Diluted | 259,707 | 264,079 | 260,877 | 264,031 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
VERTEX PHARMACEUTICALS INCORPORATED
Condensed Consolidated Statements of Comprehensive Income
(unaudited)
(in thousands)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
| Net income | $ | 851,928 | $ | 667,434 | $ | 1,571,990 | $ | 2,107,457 | |||||||||||||||
| Other comprehensive income (loss): | |||||||||||||||||||||||
| Unrealized holding (losses) gains on marketable securities, net | (56) | (1,132) | (329) | 818 | |||||||||||||||||||
| Unrealized gains (losses) on foreign currency forward contracts, net of tax of $(9.6) million, $7.6 million, $(21.2) million and $7.3 million, respectively | 34,766 | (26,313) | 77,011 | (27,211) | |||||||||||||||||||
| Foreign currency translation adjustment | 1,986 | 584 | 3,335 | (12,616) | |||||||||||||||||||
| Total other comprehensive income (loss) | 36,696 | (26,861) | 80,017 | (39,009) | |||||||||||||||||||
| Comprehensive income | $ | 888,624 | $ | 640,573 | $ | 1,652,007 | $ | 2,068,448 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
VERTEX PHARMACEUTICALS INCORPORATED
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands, except per share amounts)
| September 30, | December 31, | ||||||||||
| 2021 | 2020 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 6,275,698 | $ | 5,988,187 | |||||||
| Marketable securities | 685,187 | 670,710 | |||||||||
| Accounts receivable, net | 1,100,372 | 885,352 | |||||||||
| Inventories | 333,456 | 280,777 | |||||||||
| Prepaid expenses and other current assets | 457,827 | 308,353 | |||||||||
| Total current assets | 8,852,540 | 8,133,379 | |||||||||
| Property and equipment, net | 1,042,347 | 958,534 | |||||||||
| Goodwill | 1,002,158 | 1,002,158 | |||||||||
| Intangible assets | 400,000 | 400,000 | |||||||||
| Deferred tax assets | 933,839 | 882,779 | |||||||||
| Operating lease assets | 312,343 | 325,564 | |||||||||
| Other assets | 75,518 | 49,394 | |||||||||
| Total assets | $ | 12,618,745 | $ | 11,751,808 | |||||||
| Liabilities and Shareholders’ Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 127,863 | $ | 155,139 | |||||||
| Accrued expenses | 1,584,992 | 1,404,971 | |||||||||
| Other current liabilities | 201,409 | 317,423 | |||||||||
| Total current liabilities | 1,914,264 | 1,877,533 | |||||||||
| Long-term finance lease liabilities | 513,255 | 539,042 | |||||||||
| Long-term operating lease liabilities | 363,545 | 350,463 | |||||||||
| Long-term contingent consideration | 188,500 | 189,600 | |||||||||
| Other long-term liabilities | 108,473 | 108,355 | |||||||||
| Total liabilities | 3,088,037 | 3,064,993 | |||||||||
| Commitments and contingencies | — | — | |||||||||
| Shareholders’ equity: | |||||||||||
| Preferred stock, $0.01 par value; 1,000 shares authorized; none issued and outstanding | — | — | |||||||||
| Common stock, $0.01 par value; 500,000 shares authorized, 256,206 and 259,890 shares issued and outstanding, respectively | 2,562 | 2,599 | |||||||||
| Additional paid-in capital | 7,085,950 | 7,894,027 | |||||||||
| Accumulated other comprehensive income (loss) | 11,537 | (68,480) | |||||||||
| Retained earnings | 2,430,659 | 858,669 | |||||||||
| Total shareholders’ equity | 9,530,708 | 8,686,815 | |||||||||
| Total liabilities and shareholders’ equity | $ | 12,618,745 | $ | 11,751,808 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
VERTEX PHARMACEUTICALS INCORPORATED
Condensed Consolidated Statements of Shareholders’ Equity
(unaudited)
(in thousands)
| Three Months Ended | |||||||||||||||||||||||||||||||||||
| Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Retained Earnings (Accumulated Deficit) | Total Shareholders’ Equity | |||||||||||||||||||||||||||||||
| Shares | Amount | ||||||||||||||||||||||||||||||||||
| Balance at June 30, 2020 | 260,124 | $ | 2,601 | $ | 7,943,717 | $ | (14,121) | $ | (412,955) | $ | 7,519,242 | ||||||||||||||||||||||||
| Other comprehensive loss, net of tax | — | — | — | (26,861) | — | (26,861) | |||||||||||||||||||||||||||||
| Net income | — | — | — | — | 667,434 | 667,434 | |||||||||||||||||||||||||||||
| Repurchase of common stock | (403) | (4) | (108,003) | — | — | (108,007) | |||||||||||||||||||||||||||||
| Common stock withheld for employee tax obligations | (141) | (1) | (40,527) | — | — | (40,528) | |||||||||||||||||||||||||||||
| Issuance of common stock under benefit plans | 594 | 5 | 21,699 | — | — | 21,704 | |||||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | 100,489 | — | — | 100,489 | |||||||||||||||||||||||||||||
| Balance at September 30, 2020 | 260,174 | $ | 2,601 | $ | 7,917,375 | $ | (40,982) | $ | 254,479 | $ | 8,133,473 | ||||||||||||||||||||||||
| Balance at June 30, 2021 | 259,114 | $ | 2,591 | $ | 7,640,233 | $ | (25,159) | $ | 1,578,731 | $ | 9,196,396 | ||||||||||||||||||||||||
| Other comprehensive income, net of tax | — | — | — | 36,696 | — | 36,696 | |||||||||||||||||||||||||||||
| Net income | — | — | — | — | 851,928 | 851,928 | |||||||||||||||||||||||||||||
| Repurchase of common stock | (3,293) | (33) | (642,240) | — | — | (642,273) | |||||||||||||||||||||||||||||
| Common stock withheld for employee tax obligations | (144) | (1) | (28,558) | — | — | (28,559) | |||||||||||||||||||||||||||||
| Issuance of common stock under benefit plans | 529 | 5 | 12,862 | — | — | 12,867 | |||||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | 103,653 | — | — | 103,653 | |||||||||||||||||||||||||||||
| Balance at September 30, 2021 | 256,206 | $ | 2,562 | $ | 7,085,950 | $ | 11,537 | $ | 2,430,659 | $ | 9,530,708 | ||||||||||||||||||||||||
| Nine Months Ended | |||||||||||||||||||||||||||||||||||
| Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Retained Earnings (Accumulated Deficit) | Total Shareholders’ Equity | |||||||||||||||||||||||||||||||
| Shares | Amount | ||||||||||||||||||||||||||||||||||
| Balance at December 31, 2019 | 258,993 | $ | 2,589 | $ | 7,937,606 | $ | (1,973) | $ | (1,852,978) | $ | 6,085,244 | ||||||||||||||||||||||||
| Other comprehensive loss, net of tax | — | — | — | (39,009) | — | (39,009) | |||||||||||||||||||||||||||||
| Net income | — | — | — | — | 2,107,457 | 2,107,457 | |||||||||||||||||||||||||||||
| Repurchase of common stock | (1,807) | (18) | (408,015) | — | — | (408,033) | |||||||||||||||||||||||||||||
| Common stock withheld for employee tax obligations | (727) | (7) | (179,768) | — | — | (179,775) | |||||||||||||||||||||||||||||
| Issuance of common stock under benefit plans | 3,715 | 37 | 232,042 | — | — | 232,079 | |||||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | 335,510 | — | — | 335,510 | |||||||||||||||||||||||||||||
| Balance at September 30, 2020 | 260,174 | $ | 2,601 | $ | 7,917,375 | $ | (40,982) | $ | 254,479 | $ | 8,133,473 | ||||||||||||||||||||||||
| Balance at December 31, 2020 | 259,890 | $ | 2,599 | $ | 7,894,027 | $ | (68,480) | $ | 858,669 | $ | 8,686,815 | ||||||||||||||||||||||||
| Other comprehensive income, net of tax | — | — | — | 80,017 | — | 80,017 | |||||||||||||||||||||||||||||
| Net income | — | — | — | — | 1,571,990 | 1,571,990 | |||||||||||||||||||||||||||||
| Repurchase of common stock | (5,282) | (53) | (1,067,172) | — | — | (1,067,225) | |||||||||||||||||||||||||||||
| Common stock withheld for employee tax obligations | (633) | (6) | (134,217) | — | — | (134,223) | |||||||||||||||||||||||||||||
| Issuance of common stock under benefit plans | 2,231 | 22 | 66,707 | — | — | 66,729 | |||||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | 326,605 | — | — | 326,605 | |||||||||||||||||||||||||||||
| Balance at September 30, 2021 | 256,206 | $ | 2,562 | $ | 7,085,950 | $ | 11,537 | $ | 2,430,659 | $ | 9,530,708 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
VERTEX PHARMACEUTICALS INCORPORATED
Condensed Consolidated Statements of Cash Flows
(unaudited)
(in thousands)
| Nine Months Ended September 30, | |||||||||||
| 2021 | 2020 | ||||||||||
| Cash flows from operating activities: | |||||||||||
| Net income | $ | 1,571,990 | $ | 2,107,457 | |||||||
| Adjustments to reconcile net income to net cash provided by operating activities: | |||||||||||
| Stock-based compensation expense | 322,792 | 332,434 | |||||||||
| Depreciation expense | 91,768 | 80,160 | |||||||||
| (Decrease) increase in fair value of contingent consideration | (1,100) | 12,600 | |||||||||
| Deferred income taxes | (112,654) | 65,110 | |||||||||
| Gains on equity securities | (4,993) | (140,866) | |||||||||
| Other non-cash items, net | 20,588 | 52,371 | |||||||||
| Changes in operating assets and liabilities: | |||||||||||
| Accounts receivable, net | (231,166) | (151,191) | |||||||||
| Inventories | (65,827) | (94,907) | |||||||||
| Prepaid expenses and other assets | (107,672) | (264,909) | |||||||||
| Accounts payable | (22,043) | 16,153 | |||||||||
| Accrued expenses | 254,157 | 451,084 | |||||||||
| Other liabilities | (67,333) | 296,477 | |||||||||
| Net cash provided by operating activities | 1,648,507 | 2,761,973 | |||||||||
| Cash flows from investing activities: | |||||||||||
| Purchases of available-for-sale debt securities | (447,759) | (246,937) | |||||||||
| Maturities of available-for-sale debt securities | 452,133 | 184,419 | |||||||||
| Purchases of property and equipment | (173,285) | (212,109) | |||||||||
| Investment in equity securities and notes receivable | (37,991) | (19,327) | |||||||||
| Sale of equity securities | — | 149,595 | |||||||||
| Net cash used in investing activities | (206,902) | (144,359) | |||||||||
| Cash flows from financing activities: | |||||||||||
| Issuances of common stock under benefit plans | 67,289 | 234,854 | |||||||||
| Repurchases of common stock | (1,057,225) | (408,033) | |||||||||
| Payments in connection with common stock withheld for employee tax obligations | (134,223) | (179,775) | |||||||||
| Payments on finance leases | (34,592) | (31,378) | |||||||||
| Proceeds from finance leases | 12,647 | 8,642 | |||||||||
| Other financing activities | 4,339 | (4,399) | |||||||||
| Net cash used in financing activities | (1,141,765) | (380,089) | |||||||||
| Effect of changes in exchange rates on cash | (8,472) | 2,779 | |||||||||
| Net increase in cash, cash equivalents and restricted cash | 291,368 | 2,240,304 | |||||||||
| Cash, cash equivalents and restricted cash—beginning of period | 5,988,845 | 3,120,681 | |||||||||
| Cash, cash equivalents and restricted cash—end of period | $ | 6,280,213 | $ | 5,360,985 | |||||||
| Supplemental disclosure of cash flow information: | |||||||||||
| Cash paid for interest | $ | 42,698 | $ | 40,769 | |||||||
| Cash paid for income taxes | $ | 381,533 | $ | 81,684 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
**A.**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” or the “Company”) 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 the Company and its wholly-owned subsidiaries. All material intercompany balances and transactions have been eliminated. The Company operates in one segment, pharmaceuticals. The Company has reclassified certain items from the prior year’s condensed consolidated financial statements to conform to the current year’s presentation.
Certain information and footnote disclosures normally included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 (the “2020 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 operations for the interim periods ended September 30, 2021 and 2020.
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, 2020, which are contained in the Company’s 2020 Annual Report on Form 10-K.
Use of Estimates
The preparation of condensed consolidated financial statements in accordance with U.S. GAAP requires management 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 the condensed consolidated financial statements, and the amounts of revenues and expenses during the reported periods. The Company bases its estimates on historical experience and various other assumptions, including in certain circumstances future projections that management believes 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
Income Taxes
In 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740) (“ASU 2019-12”), which simplifies the accounting for income taxes. ASU 2019-12 became effective on January 1, 2021. The adoption of ASU 2019-12 did not have a significant impact on the Company’s condensed consolidated financial statements.
For a discussion of other recent accounting pronouncements please refer to Note A, “Nature of Business and Accounting Policies,” in the Company’s 2020 Annual Report on Form 10-K.
Summary of Significant Accounting Policies
The Company’s significant accounting policies are described in Note A, “Nature of Business and Accounting Policies,” in its 2020 Annual Report on Form 10-K.
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
**B.**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, | ||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||
| TRIKAFTA/KAFTRIO | $ | 1,555,772 | $ | 960,308 | $ | 4,004,600 | $ | 2,773,256 | |||||||||||||||
| SYMDEKO/SYMKEVI | 81,415 | 156,178 | 339,969 | 501,066 | |||||||||||||||||||
| ORKAMBI | 184,561 | 225,919 | 624,224 | 692,038 | |||||||||||||||||||
| KALYDECO | 162,416 | 193,866 | 532,046 | 609,503 | |||||||||||||||||||
| Total product revenues, net | $ | 1,984,164 | $ | 1,536,271 | $ | 5,500,839 | $ | 4,575,863 |
Product Revenues by Geographic Location
Total net product revenues by geographic region, based on the location of the customer, consisted of the following:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||
| United States | $ | 1,382,892 | $ | 1,222,565 | $ | 3,893,245 | $ | 3,620,467 | |||||||||||||||
| Outside of the United States | |||||||||||||||||||||||
| Europe | 518,826 | 251,366 | 1,382,701 | 766,438 | |||||||||||||||||||
| Other | 82,446 | 62,340 | 224,893 | 188,958 | |||||||||||||||||||
| Total product revenues outside of the United States | 601,272 | 313,706 | 1,607,594 | 955,396 | |||||||||||||||||||
| Total product revenues, net | $ | 1,984,164 | $ | 1,536,271 | $ | 5,500,839 | $ | 4,575,863 |
Contract Liabilities
The Company had contract liabilities of $104.1 million and $191.5 million as of September 30, 2021 and December 31, 2020, respectively, related to annual contracts with government-owned and supported customers in international markets that limit the amount of annual reimbursement the Company 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. The Company defers 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. The Company’s product revenue contracts include performance obligations that are one year or less.
The Company’s 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 the Company’s fiscal year. In these markets, the Company recognizes 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.
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
**C.**Collaborative Arrangements
The Company has entered into numerous agreements pursuant to which it collaborates with third parties on research, development and commercialization programs, including in-license and out-license agreements.
The Company’s in-license and out-license agreements that had a significant impact on its financial statements for the three and nine months ended September 30, 2021 and 2020, or were new or materially revised during the nine months ended September 30, 2021, are described below. Additional in-license and out-license agreements were described in Note B, “Collaborative Arrangements,” of the Company’s 2020 Annual Report on Form 10-K.
In-license Agreements
The Company has entered into a number of in-license agreements in order to advance and obtain access to technologies and services related to its research and early-development activities. The Company is generally required to make an upfront payment upon execution of the license agreement; 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 the collaboration.
Pursuant to the terms of its in-license agreements, the Company’s collaborators typically lead the discovery efforts and the Company leads all preclinical, development and commercialization activities associated with the advancement of any drug candidates and funds all expenses.
The Company typically can terminate its in-license agreements by providing advance notice to its collaborators; the required length of notice is dependent on whether any product developed under the license agreement has received marketing approval. The Company’s 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.
The Company’s “Research and development expenses” included $26.8 million and $986.8 million for the three and nine months ended September 30, 2021, respectively, and $80.1 million and $143.3 million for the three and nine months ended September 30, 2020, respectively, related to upfront and milestone payments pursuant to its in-license agreements.
CRISPR Therapeutics AG - CRISPR-Cas9 Gene-editing Therapies
In 2015, the Company 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. The Company had the exclusive right to license certain targets. In 2019, the Company elected to exclusively license three targets, including cystic fibrosis, pursuant to the CRISPR Agreement. For each of the three targets that the Company 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 net product sales.
In 2017, the Company entered into a joint development and commercialization agreement with CRISPR pursuant to the terms of the CRISPR Agreement (the “Original CTX001 JDCA”), under which the Company and CRISPR were co-developing and preparing to co-commercialize CTX001 for the treatment of hemoglobinopathies, including treatments for sickle cell disease and beta thalassemia.
In the second quarter of 2021, the Company and CRISPR amended and restated the Original CTX001 JDCA (the “A&R JDCA”), pursuant to which the parties agreed to, among other things, (a) adjust the governance structure for the collaboration and adjust the responsibilities of each party thereunder; (b) adjust the allocation of net profits and net losses between the parties; and (c) exclusively license (subject to CRISPR’s reserved rights to conduct certain activities) certain intellectual property rights to the Company relating to the products that may be researched, developed, manufactured and commercialized under such agreement.
Pursuant to the A&R JDCA, the Company is now leading global development, manufacturing and commercialization of CTX001, with support from CRISPR. Subject to the terms and conditions of the A&R JDCA, the Company also has the right
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
to conduct all research, development, manufacturing and commercialization activities relating to the product candidates and products under the A&R JDCA (including CTX001) throughout the world subject to CRISPR’s reserved right to conduct certain activities.
In connection with the amendment and restatement of this agreement, the Company made a $900.0 million upfront payment to CRISPR in the second quarter of 2021. The Company concluded that it did not have any alternative future use for the acquired in-process research and development and recorded this upfront payment to “Research and development expenses.” CRISPR has the potential to receive an additional one-time $200.0 million milestone payment upon receipt of the first marketing approval of CTX001 from the U.S. Food or Drug Administration or the European Commission.
The Company and CRISPR shared equally all expenses incurred under the Original CTX001 JDCA. On July 1, 2021, with respect to CTX001, the net profits and net losses incurred pursuant to the A&R JDCA began to be allocated 60% to the Company and 40% to CRISPR, while all other product candidates and products continued to have net profits and net losses shared equally between the parties. The Company concluded that the Original CTX001 JDCA and the A&R JDCA are cost-sharing arrangements, which result in the net impact of the arrangements being recorded in “Research and development expenses” in its condensed consolidated statements of operations. During the three and nine months ended September 30, 2021 and 2020, the Company recognized the following amounts in total related to these agreements:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||
| Total research and development expenses incurred under the Original CTX001 JDCA and A&R JDCA | $ | 58,659 | $ | 28,623 | $ | 147,448 | $ | 66,720 | |||||||||||||||
| Vertex’s share recognized in research and development expenses in condensed consolidated statement of operations | 35,195 | 14,311 | 79,590 | 33,360 |
Moderna, Inc.
In 2016, the Company entered into a strategic collaboration and licensing agreement with Moderna, Inc. (“Moderna”), pursuant to which the parties are seeking to identify and develop messenger ribonucleic acid (“mRNA”) therapeutics for the treatment of CF.
In September 2020, the Company entered into a new strategic collaboration and licensing agreement with Moderna (the “2020 Moderna Agreement”) aimed at the discovery and development of lipid nanoparticles and mRNAs that can deliver gene-editing therapies to lung cells for the treatment of CF. Pursuant to the 2020 Moderna Agreement, Moderna received an upfront payment of $75.0 million and is eligible to receive up to $380.0 million in development, regulatory and commercial milestones as well as royalties on net product sales. The Company determined that substantially all of the fair value of the 2020 Moderna Agreement was attributable to in-process research and development and no substantive processes were acquired that would constitute a business. The Company concluded that it did not have any alternative future use for the acquired in-process research and development and recorded the upfront payment to “Research and development expenses” in the third quarter of 2020.
Out-license Agreements
The Company has entered into licensing agreements pursuant to which it has out-licensed rights to certain drug candidates to third-party collaborators. Pursuant to these out-license agreements, the Company’s collaborators become responsible for all costs related to the continued development of such drug candidates and obtain development and commercialization rights to these drug candidates. Depending on the terms of the agreements, the Company’s collaborators may be required to make upfront payments, milestone payments upon the achievement of certain product research and development objectives and may also be required to pay royalties on future sales, if any, of commercial products resulting from the collaboration. The termination provisions associated with these collaborations are generally the same as those described above related to the Company’s in-license agreements. None of the Company’s out-license agreements had a significant impact on the Company’s condensed consolidated statement of operations during the three and nine months ended September 30, 2021 and 2020.
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
Cystic Fibrosis Foundation
The Company has a research, development and commercialization agreement that was originally entered into in 2004 with the Cystic Fibrosis Foundation, as successor in interest to the Cystic Fibrosis Foundation Therapeutics, Inc. This agreement was most recently amended in 2016. Pursuant to the agreement, as amended, the Company agreed to pay royalties ranging from low-single digits to mid-single digits on potential sales of certain compounds first synthesized and/or tested between March 1, 2014 and August 31, 2016, including elexacaftor, and 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 KALYDECO (ivacaftor), ORKAMBI (lumacaftor in combination with ivacaftor) and SYMDEKO/SYMKEVI (tezacaftor in combination with ivacaftor). For combination products, such as ORKAMBI, SYMDEKO/SYMKEVI and TRIKAFTA/KAFTRIO (elexacaftor/tezacaftor/ivacaftor and ivacaftor), sales are allocated equally to each of the active pharmaceutical ingredients in the combination product.
**D.**Earnings Per Share
Basic net income per common share is based upon the weighted-average number of common shares outstanding during the period. Diluted net income per common share utilizing the treasury-stock method is based upon the weighted-average number of common shares outstanding during the period plus additional weighted-average common equivalent shares outstanding during the period when the effect is dilutive.
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, | ||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
| (in thousands, except per share amounts) | |||||||||||||||||||||||
| Net income | $ | 851,928 | $ | 667,434 | $ | 1,571,990 | $ | 2,107,457 | |||||||||||||||
| Basic weighted-average common shares outstanding | 257,876 | 260,392 | 258,740 | 260,313 | |||||||||||||||||||
| Effect of potentially dilutive securities: | |||||||||||||||||||||||
| Stock options | 971 | 1,887 | 1,124 | 1,936 | |||||||||||||||||||
| Restricted stock units (including PSUs) | 841 | 1,788 | 1,003 | 1,765 | |||||||||||||||||||
| Employee stock purchase program | 19 | 12 | 10 | 17 | |||||||||||||||||||
| Diluted weighted-average common shares outstanding | 259,707 | 264,079 | 260,877 | 264,031 | |||||||||||||||||||
| Basic net income per common share | $ | 3.30 | $ | 2.56 | $ | 6.08 | $ | 8.10 | |||||||||||||||
| Diluted net income per common share | $ | 3.28 | $ | 2.53 | $ | 6.03 | $ | 7.98 |
The Company did not include the securities in the following table in the computation of the 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, | ||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||
| Stock options | 1,060 | 23 | 711 | 303 | |||||||||||||||||||
| Unvested restricted stock units (including PSUs) | 204 | 252 | 440 | 229 |
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
**E.**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 the Company’s 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 the Company’s assessment of the assumptions that market participants would use in pricing the asset or liability. |
The Company’s investment strategy is focused on capital preservation. The Company invests in instruments that meet the credit quality standards outlined in the Company’s investment policy. This policy also limits the amount of credit exposure to any one issue or type of instrument. The Company maintains strategic investments separately from the investment policy that governs its other cash, cash equivalents and marketable securities as described in Note F, “Marketable Securities and Equity Investments.” Additionally, the Company utilizes foreign currency forward contracts intended to mitigate the effect of changes in foreign exchange rates on its condensed consolidated statement of operations.
During the three and nine months ended September 30, 2021 and 2020, the Company did not record any other-than-temporary impairment charges related to its financial assets.
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
The following tables set forth the Company’s financial assets and liabilities subject to fair value measurements by level within the fair value hierarchy (and does not include $2.7 billion and $2.8 billion of cash as of September 30, 2021 and December 31, 2020, respectively):
| As of September 30, 2021 | As of December 31, 2020 | ||||||||||||||||||||||||||||||||||||||||||||||
| Total | Level 1 | Level 2 | Level 3 | Total | Level 1 | Level 2 | Level 3 | ||||||||||||||||||||||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||||||||||||||||||||||||||
| Financial instruments carried at fair value (asset positions): | |||||||||||||||||||||||||||||||||||||||||||||||
| Cash equivalents: | |||||||||||||||||||||||||||||||||||||||||||||||
| Money market funds | $ | 3,578,764 | $ | 3,578,764 | $ | — | $ | — | $ | 3,141,053 | $ | 3,141,053 | $ | — | $ | — | |||||||||||||||||||||||||||||||
| Commercial paper | 31,998 | — | 31,998 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
| Marketable securities: | |||||||||||||||||||||||||||||||||||||||||||||||
| Corporate equity securities | 218,764 | 218,764 | — | — | 195,781 | 15,650 | 180,131 | — | |||||||||||||||||||||||||||||||||||||||
| U.S. Treasury securities | 46,539 | 46,539 | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
| Government-sponsored enterprise securities | 69,002 | 69,002 | — | — | 80,063 | 80,063 | — | — | |||||||||||||||||||||||||||||||||||||||
| Corporate debt securities | 95,359 | — | 95,359 | — | 231,598 | — | 231,598 | — | |||||||||||||||||||||||||||||||||||||||
| Commercial paper | 255,523 | — | 255,523 | — | 163,268 | — | 163,268 | — | |||||||||||||||||||||||||||||||||||||||
| Prepaid expenses and other current assets: | |||||||||||||||||||||||||||||||||||||||||||||||
| Foreign currency forward contracts | 34,300 | — | 34,300 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
| Other assets: | |||||||||||||||||||||||||||||||||||||||||||||||
| Foreign currency forward contracts | 4,781 | — | 4,781 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
| Total financial assets | $ | 4,335,030 | $ | 3,913,069 | $ | 421,961 | $ | — | $ | 3,811,763 | $ | 3,236,766 | $ | 574,997 | $ | — | |||||||||||||||||||||||||||||||
| Financial instruments carried at fair value (liability positions): | |||||||||||||||||||||||||||||||||||||||||||||||
| Other current liabilities: | |||||||||||||||||||||||||||||||||||||||||||||||
| Foreign currency forward contracts | $ | (4,356) | $ | — | $ | (4,356) | $ | — | $ | (59,184) | $ | — | $ | (59,184) | $ | — | |||||||||||||||||||||||||||||||
| Long-term contingent consideration | (188,500) | — | — | (188,500) | (189,600) | — | — | (189,600) | |||||||||||||||||||||||||||||||||||||||
| Other long-term liabilities: | |||||||||||||||||||||||||||||||||||||||||||||||
| Foreign currency forward contracts | (29) | — | (29) | — | (4,283) | — | (4,283) | — | |||||||||||||||||||||||||||||||||||||||
| Total financial liabilities | $ | (192,885) | $ | — | $ | (4,385) | $ | (188,500) | $ | (253,067) | $ | — | $ | (63,467) | $ | (189,600) |
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
The Company classifies its investments in publicly traded corporate equity securities as “Marketable securities” on its condensed consolidated balance sheets. Generally, the Company’s investments in the common stock of these publicly traded companies are valued based on Level 1 inputs because they have readily determinable fair values. However, certain of the Company’s 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. Please refer to Note F, “Marketable Securities and Equity Investments,” for further information on these investments.
Fair Value of Contingent Consideration
In 2019, the Company acquired Exonics Therapeutics, Inc. (“Exonics”), a privately-held company focused on creating transformative gene-editing therapies to repair mutations that cause DMD and other severe neuromuscular diseases, including DM1. The Company’s Level 3 contingent consideration liabilities are related to $678.3 million of development and regulatory milestones potentially payable to Exonics’ former equity holders. The Company bases its estimates of the probability of achieving the milestones relevant to the fair value of contingent payments on industry data attributable to rare diseases. The discount rates used in the valuation model for contingent payments, which were between 0.3% and 2.2% as of September 30, 2021, represent a measure of credit risk and market risk associated with settling the liabilities. Significant
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
judgment is used in determining the appropriateness of these assumptions at each reporting period. Due to the uncertainties associated with development and commercialization of drug candidates in the pharmaceutical industry and the effects of changes in other assumptions including discount rates, the Company expects its estimates regarding the fair value of contingent consideration to change in the future, resulting in adjustments to the fair value of the Company’s contingent consideration liabilities, and the effect of any such adjustments could be material.
The following table represents a rollforward of the fair value of the Company’s contingent consideration liabilities:
| Nine Months Ended September 30, 2021 | |||||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||
| Balance at December 31, 2020 | $ | 189,600 | |||||||||||||||||||||
| Decrease in fair value of contingent payments | (1,100) | ||||||||||||||||||||||
| Balance at September 30, 2021 | $ | 188,500 |
**F.**Marketable Securities and Equity Investments
A summary of the Company’s cash equivalents and marketable securities, which are recorded at fair value (and do not include $2.7 billion and $2.8 billion of cash as of September 30, 2021 and December 31, 2020, respectively), is shown below:
| As of September 30, 2021 | As of December 31, 2020 | ||||||||||||||||||||||||||||||||||||||||||||||
| Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | ||||||||||||||||||||||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||||||||||||||||||||||||||
| Cash equivalents: | |||||||||||||||||||||||||||||||||||||||||||||||
| Money market funds | $ | 3,578,764 | $ | — | $ | — | $ | 3,578,764 | $ | 3,141,053 | $ | — | $ | — | $ | 3,141,053 | |||||||||||||||||||||||||||||||
| Commercial paper | 31,997 | 1 | — | 31,998 | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
| Total cash equivalents | $ | 3,610,761 | $ | 1 | $ | — | $ | 3,610,762 | $ | 3,141,053 | $ | — | $ | — | $ | 3,141,053 | |||||||||||||||||||||||||||||||
| Marketable securities: | |||||||||||||||||||||||||||||||||||||||||||||||
| U.S. Treasury securities | $ | 46,536 | $ | 4 | $ | (1) | $ | 46,539 | $ | — | $ | — | $ | — | $ | — | |||||||||||||||||||||||||||||||
| Government-sponsored enterprise securities | 68,996 | 8 | (2) | 69,002 | 80,046 | 17 | — | 80,063 | |||||||||||||||||||||||||||||||||||||||
| Corporate debt securities | 95,385 | 26 | (52) | 95,359 | 231,263 | 377 | (42) | 231,598 | |||||||||||||||||||||||||||||||||||||||
| Commercial paper | 255,501 | 40 | (18) | 255,523 | 163,286 | 19 | (37) | 163,268 | |||||||||||||||||||||||||||||||||||||||
| Total marketable debt securities | 466,418 | 78 | (73) | 466,423 | 474,595 | 413 | (79) | 474,929 | |||||||||||||||||||||||||||||||||||||||
| Corporate equity securities | 69,418 | 150,263 | (917) | 218,764 | 51,427 | 144,354 | — | 195,781 | |||||||||||||||||||||||||||||||||||||||
| Total marketable securities | $ | 535,836 | $ | 150,341 | $ | (990) | $ | 685,187 | $ | 526,022 | $ | 144,767 | $ | (79) | $ | 670,710 |
Available-for-sale debt securities were classified on the Company's condensed consolidated balance sheets at fair value as follows:
| As of September 30, 2021 | As of December 31, 2020 | ||||||||||
| (in thousands) | |||||||||||
| Cash and cash equivalents | $ | 3,610,762 | $ | 3,141,053 | |||||||
| Marketable securities | 466,423 | 474,929 | |||||||||
| Total | $ | 4,077,185 | $ | 3,615,982 |
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
Available-for-sale debt securities by contractual maturity were as follows:
| As of September 30, 2021 | As of December 31, 2020 | ||||||||||
| (in thousands) | |||||||||||
| Matures within one year | $ | 4,014,441 | $ | 3,526,185 | |||||||
| Matures after one year through five years | 62,744 | 89,797 | |||||||||
| Total | $ | 4,077,185 | $ | 3,615,982 |
The Company has a limited number of available-for-sale debt securities in insignificant loss positions as of September 30, 2021, which it does not intend to sell and has concluded it will not be required to sell before recovery of the amortized costs for the investments at maturity. The Company did not record any charges for other-than-temporary declines in the fair value of available-for-sale debt securities or gross realized gains or losses in the three and nine months ended September 30, 2021 and 2020.
The Company records changes in the fair value of its investments in corporate equity securities to “Other income (expense), net” on its condensed consolidated statements of operations. During the three and nine months ended September 30, 2021 and 2020, the Company’s net unrealized 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, | ||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||
| Net unrealized gains | $ | 46,679 | $ | 69,834 | $ | 4,993 | $ | 102,317 |
During the nine months ended September 30, 2020, the Company received proceeds of $149.6 million related to the sale of the common stock of publicly traded companies, which had a total original weighted-average cost basis of $51.3 million. There were no sales of the common stock of publicly traded companies during the nine months ended September 30, 2021.
As of September 30, 2021, the carrying value of the Company’s equity investments without readily determinable fair values, which are recorded in “Other assets” on its condensed consolidated balance sheets, was $35.9 million.
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
**G.**Accumulated Other Comprehensive Income (Loss)
The following table summarizes the changes in accumulated other comprehensive income (loss) by component:
| Foreign Currency Translation Adjustment | Unrealized Holding Gains (Losses), Net of Tax | Total | |||||||||||||||||||||
| On Available-For-Sale Debt Securities | On Foreign Currency Forward Contracts | ||||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||
| Balance at December 31, 2020 | $ | (15,678) | $ | 334 | $ | (53,136) | $ | (68,480) | |||||||||||||||
| Other comprehensive income (loss) before reclassifications | 3,335 | (329) | 46,175 | 49,181 | |||||||||||||||||||
| Amounts reclassified from accumulated other comprehensive (loss) income | — | — | 30,836 | 30,836 | |||||||||||||||||||
| Net current period other comprehensive income (loss) | 3,335 | (329) | 77,011 | 80,017 | |||||||||||||||||||
| Balance at September 30, 2021 | $ | (12,343) | $ | 5 | $ | 23,875 | $ | 11,537 | |||||||||||||||
| Balance at December 31, 2019 | $ | (895) | $ | 503 | $ | (1,581) | $ | (1,973) | |||||||||||||||
| Other comprehensive (loss) income before reclassifications | (12,616) | 818 | (20,913) | (32,711) | |||||||||||||||||||
| Amounts reclassified from accumulated other comprehensive loss | — | — | (6,298) | (6,298) | |||||||||||||||||||
| Net current period other comprehensive (loss) income | (12,616) | 818 | (27,211) | (39,009) | |||||||||||||||||||
| Balance at September 30, 2020 | $ | (13,511) | $ | 1,321 | $ | (28,792) | $ | (40,982) |
**H.**Hedging
Foreign currency forward contracts - Designated as hedging instruments
The Company maintains a hedging program intended to mitigate the effect of changes in foreign exchange rates for a portion of the Company’s 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 to eighteen months. The Company recognizes realized gains and losses for the effective portion of such contracts in “Product revenues, net” in its condensed consolidated statements of operations in the same period that it recognizes the product revenues that were impacted by the hedged foreign exchange rate changes.
The Company formally documents the relationship between foreign currency forward contracts (hedging instruments) and forecasted product revenues (hedged items), as well as the Company’s 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. The Company also formally assesses, 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 the Company 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, the Company would discontinue hedge accounting treatment prospectively. The Company measures 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, 2021, all hedges were determined to be highly effective.
The Company considers the impact of its counterparties’ credit risk on the fair value of the foreign currency forward contracts. As of September 30, 2021 and December 31, 2020, credit risk did not change the fair value of the Company’s foreign currency forward contracts.
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
The following table summarizes the notional amount in U.S. dollars of the Company’s outstanding foreign currency forward contracts designated as cash flow hedges under U.S. GAAP:
| As of September 30, 2021 | As of December 31, 2020 | ||||||||||
| Foreign Currency | (in thousands) | ||||||||||
| Euro | $ | 1,194,338 | $ | 745,099 | |||||||
| British pound sterling | 277,815 | 160,427 | |||||||||
| Australian dollar | 95,970 | 99,922 | |||||||||
| Canadian dollar | 87,259 | 86,468 | |||||||||
| Swiss Franc | 41,335 | — | |||||||||
| Total foreign currency forward contracts | $ | 1,696,717 | $ | 1,091,916 |
Foreign currency forward contracts - Not designated as hedging instruments
The Company also enters 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. The Company recognizes realized gains and losses for such contracts in “Other income (expense), net” in its condensed consolidated statements of operations each period. As of September 30, 2021, the notional amount of the Company’s outstanding foreign currency forward contracts where hedge accounting under U.S. GAAP is not applied was $306.2 million.
During the three and nine months ended September 30, 2021 and 2020, the Company recognized the following related to foreign currency forward contracts in its condensed consolidated statements of operations:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||
| Designated as hedging instruments - Reclassified from AOCI | |||||||||||||||||||||||
| Product revenues, net | $ | (5,224) | $ | (7,249) | $ | (39,342) | $ | 8,039 | |||||||||||||||
| Not designated as hedging instruments | |||||||||||||||||||||||
| Other income (expense), net | $ | (400) | $ | 25,897 | $ | (9,350) | $ | 15,724 | |||||||||||||||
| Total reported in the Condensed Consolidated Statement of Operations | |||||||||||||||||||||||
| Product revenues, net | $ | 1,984,164 | $ | 1,536,271 | $ | 5,500,839 | $ | 4,575,863 | |||||||||||||||
| Other income (expense), net | $ | 42,368 | $ | 84,386 | $ | (2,234) | $ | 139,621 |
The following table summarizes the fair value of the Company’s outstanding foreign currency forward contracts designated as cash flow hedges under U.S. GAAP included on its condensed consolidated balance sheets:
| As of September 30, 2021 | ||||||||||||||||||||
| Assets | Liabilities | |||||||||||||||||||
| Classification | Fair Value | Classification | Fair Value | |||||||||||||||||
| (in thousands) | ||||||||||||||||||||
| Prepaid expenses and other current assets | $ | 34,300 | Other current liabilities | $ | (4,356) | |||||||||||||||
| Other assets | 4,781 | Other long-term liabilities | (29) | |||||||||||||||||
| Total assets | $ | 39,081 | Total liabilities | $ | (4,385) |
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
| As of December 31, 2020 | ||||||||||||||||||||
| Assets | Liabilities | |||||||||||||||||||
| Classification | Fair Value | Classification | Fair Value | |||||||||||||||||
| (in thousands) | ||||||||||||||||||||
| Prepaid expenses and other current assets | $ | — | Other current liabilities | $ | (59,184) | |||||||||||||||
| Other assets | — | Other long-term liabilities | (4,283) | |||||||||||||||||
| Total assets | $ | — | Total liabilities | $ | (63,467) |
As of September 30, 2021, the Company expects 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.
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 the Company’s condensed consolidated balance sheets:
| As of September 30, 2021 | |||||||||||||||||||||||||||||
| Gross Amounts Recognized | Gross Amounts Offset | Gross Amounts Presented | Gross Amounts Not Offset | Legal Offset | |||||||||||||||||||||||||
| Foreign currency forward contracts | (in thousands) | ||||||||||||||||||||||||||||
| Total assets | $ | 39,081 | $ | — | $ | 39,081 | $ | (4,385) | $ | 34,696 | |||||||||||||||||||
| Total liabilities | (4,385) | — | (4,385) | 4,385 | — |
| As of December 31, 2020 | |||||||||||||||||||||||||||||
| Gross Amounts Recognized | Gross Amounts Offset | Gross Amounts Presented | Gross Amounts Not Offset | Legal Offset | |||||||||||||||||||||||||
| Foreign currency forward contracts | (in thousands) | ||||||||||||||||||||||||||||
| Total assets | $ | — | $ | — | $ | — | $ | — | $ | — | |||||||||||||||||||
| Total liabilities | (63,467) | — | (63,467) | — | (63,467) | ||||||||||||||||||||||||
**I.**Inventories
Inventories consisted of the following:
| As of September 30, 2021 | As of December 31, 2020 | ||||||||||
| (in thousands) | |||||||||||
| Raw materials | $ | 45,990 | $ | 46,232 | |||||||
| Work-in-process | 192,650 | 161,324 | |||||||||
| Finished goods | 94,816 | 73,221 | |||||||||
| Total | $ | 333,456 | $ | 280,777 |
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
**J.**Stock-based Compensation Expense and Share Repurchase Programs
Stock-based compensation expense
During the three and nine months ended September 30, 2021 and 2020, the Company recognized the following stock-based compensation expense:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||
| Stock-based compensation expense by type of award: | |||||||||||||||||||||||
| Restricted stock units (including PSUs) and restricted stock | $ | 89,458 | $ | 84,043 | $ | 279,131 | $ | 279,611 | |||||||||||||||
| Stock options | 7,875 | 13,221 | 29,580 | 47,334 | |||||||||||||||||||
| ESPP share issuances | 6,321 | 3,225 | 17,895 | 8,565 | |||||||||||||||||||
| Stock-based compensation expense related to inventories | (658) | (950) | (3,814) | (3,076) | |||||||||||||||||||
| Total stock-based compensation expense included in costs and expenses | $ | 102,996 | $ | 99,539 | $ | 322,792 | $ | 332,434 | |||||||||||||||
| Stock-based compensation expense by line item: | |||||||||||||||||||||||
| Cost of sales | $ | 1,599 | $ | 1,250 | $ | 4,570 | $ | 3,998 | |||||||||||||||
| Research and development expenses | 60,995 | 60,770 | 196,412 | 203,732 | |||||||||||||||||||
| Selling, general and administrative expenses | 40,402 | 37,519 | 121,810 | 124,704 | |||||||||||||||||||
| Total stock-based compensation expense included in costs and expenses | 102,996 | 99,539 | 322,792 | 332,434 | |||||||||||||||||||
| Income tax effect | (21,556) | (35,295) | (73,663) | (130,692) | |||||||||||||||||||
| Total stock-based compensation expense, net of tax | $ | 81,440 | $ | 64,244 | $ | 249,129 | $ | 201,742 |
Share repurchase programs
In 2019, the Company’s Board of Directors approved a share repurchase program (the “2019 Share Repurchase Program”), pursuant to which the Company repurchased $500.0 million of its common stock in 2019 and 2020. During the nine months ended September 30, 2020, the Company repurchased 1,806,587 shares of its common stock under the 2019 Share Repurchase Program for an aggregate of $408.0 million.
In November 2020, the Company’s Board of Directors approved a share repurchase program (the “2020 Share Repurchase Program”), pursuant to which the Company repurchased $500.0 million of its common stock in 2020 and the first quarter of 2021. During the three months ended March 31, 2021, the Company repurchased 1,988,941 shares of its common stock under the 2020 Share Repurchase Program for an aggregate of $424.9 million.
On June 23, 2021, the Company’s Board of Directors approved a new share repurchase program (the “2021 Share Repurchase Program”), pursuant to which the Company is authorized to repurchase up to $1.5 billion of its common stock by December 31, 2022. During the three months ended September 30, 2021, the Company repurchased 3,293,161 shares of its common stock under the 2021 Share Repurchase Program for an aggregate of $642.2 million. As of September 30, 2021, a total of $857.8 million remained available under this program.
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
**K.**Income Taxes
The Company is subject to U.S. federal, state, and foreign income taxes. During the three and nine months ended September 30, 2021 and 2020, the Company recorded the following provisions for income taxes and effective tax rates as compared to its income before provision for income taxes:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
| (in thousands, except percentages) | |||||||||||||||||||||||
| Income before provision for income taxes | $ | 1,082,741 | $ | 745,871 | $ | 1,859,446 | $ | 2,228,175 | |||||||||||||||
| Provision for income taxes | 230,813 | 78,437 | 287,456 | 120,718 |
| Effective tax rate | 21 | % | 11 | % | 15 | % | 5 | % |
The Company’s effective tax rate for the three months ended September 30, 2021 was similar to the U.S. statutory rate. The Company’s effective tax rate for the nine months ended September 30, 2021 was lower than the U.S. statutory rate primarily due to a $99.7 million discrete tax benefit associated with an increase in the U.K.’s corporate tax rate from 19% to 25%, which was enacted in June 2021 and will become effective in April 2023.
The Company’s effective tax rate for the three months ended September 30, 2020 was lower than the U.S. statutory rate primarily due to a discrete tax benefit associated with an increase in the U.K.’s corporate tax rate from 17% to 19%, which was enacted and became effective in July 2020. The Company’s effective tax rate for the nine months ended September 30, 2020 was lower than the U.S. statutory rate due to a discrete tax benefit of $209.0 million associated with an intra-entity transfer of intellectual property rights to the U.K., a discrete benefit related to the write-off of a long-term intercompany receivable, the increase in the U.K.’s corporate tax rate from 17% to 19% noted above and excess tax benefits related to stock-based compensation.
As part of the U.S. Tax Cut and Jobs Act of 2017, the Company is subject to a territorial tax system, under which it must establish an accounting policy to provide for tax on Global Intangible Low Taxed Income (“GILTI”) earned by certain foreign subsidiaries. The Company has elected to treat the impact of GILTI as a current tax expense in its provision for income taxes.
The Company has reviewed the tax positions taken, or to be taken, in its tax returns for all tax years currently open to examination by a taxing authority. Unrecognized tax benefits represent the aggregate tax effect of differences between tax return positions and the benefits recognized in the consolidated financial statements. As of September 30, 2021 and December 31, 2020, the Company had $89.0 million and $75.8 million, respectively, of net unrecognized tax benefits, which would affect the Company’s tax rate if recognized. The Company does not expect that its unrecognized tax benefits will materially change within the next twelve months.
As of September 30, 2021, foreign earnings have been retained by foreign subsidiaries for indefinite reinvestment. Upon repatriation of those earnings, in the form of dividends or otherwise, the Company could be subject to withholding taxes payable to the various foreign countries.
The Company files U.S. federal income tax returns and income tax returns in various state, local and foreign jurisdictions. The Company has various income tax audits ongoing at any time throughout the world. The Company is no longer subject to any tax assessment from an income tax examination in the U.S. or any other major taxing jurisdiction before 2011, except where the Company has net operating losses or tax credit carryforwards that originate before 2011.
**L.**Commitments and Contingencies
Revolving Credit Facilities
The Company and certain of its subsidiaries have entered into two credit agreements (the “Credit Agreements”) with Bank of America, N.A., as administrative agent and the lenders referred to therein (the “Lenders”). The Credit Agreements
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
were not drawn upon at closing and the Company has not drawn upon them to date. Amounts drawn pursuant to the Credit Agreements, if any, will be used for general corporate purposes. Any amounts borrowed under the Credit Agreements will bear interest, at the Company’s option, at either a base rate or a Eurocurrency rate, in each case plus an applicable margin based on the Company’s consolidated leverage ratio (the ratio of the Company’s total consolidated funded indebtedness to the Company’s consolidated EBITDA for the most recently completed four fiscal quarter period).
In September 2019, the Company and certain of its subsidiaries entered into a $500.0 million unsecured revolving facility (the “2019 Credit Agreement”) with the Lenders, which matures on September 17, 2024. Under the 2019 Credit Agreement, the applicable margins on base rate loans range from 0.125% to 0.500% and the applicable margins on Eurocurrency loans range from 1.125% to 1.500%. The 2019 Credit Agreement provides a sublimit of $50.0 million for letters of credit.
In September 2020, the Company and certain of its subsidiaries entered into a $2.0 billion unsecured revolving facility (the “2020 Credit Agreement”) with the Lenders, which matures on September 18, 2022. Under the 2020 Credit Agreement, the applicable margins on base rate loans range from 0.500% to 0.875% and the applicable margins on Eurocurrency loans range from 1.500% to 1.875%. The 2020 Credit Agreement does not support letters of credit.
Subject to satisfaction of certain conditions, the Company may request that the borrowing capacity for each of the Credit Agreements be increased by an additional $500.0 million. Any amounts borrowed pursuant to the Credit Agreements are guaranteed by certain of the Company’s existing and future domestic subsidiaries, subject to certain exceptions.
The Credit Agreements contain customary representations and warranties and affirmative and negative covenants, including financial covenants to maintain (x) 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 and (y) a consolidated interest coverage ratio of 2.50 to 1.00, in each case measured on a quarterly basis. As of September 30, 2021, the Company was in compliance with the covenants described above. The Credit Agreements also contain 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 Agreements are recorded over the term of the Credit Agreements and were not material to the Company’s financial statements.
Guaranties and Indemnifications
As permitted under Massachusetts law, the Company’s Articles of Organization and By-laws provide that the Company will indemnify certain of its 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 the Company could be required to make under these indemnification provisions is unlimited. However, the Company has purchased directors’ and officers’ liability insurance policies that could reduce its monetary exposure and enable it to recover a portion of any future amounts paid. No indemnification claims currently are outstanding, and the Company believes the estimated fair value of these indemnification arrangements is minimal.
The Company customarily agrees in the ordinary course of its business to indemnification provisions in agreements with clinical trial investigators and sites in its drug development programs, sponsored research agreements with academic and not-for-profit institutions, various comparable agreements involving parties performing services for the Company and its real estate leases. The Company also customarily agrees to certain indemnification provisions in its drug discovery, development and commercialization collaboration agreements. With respect to the Company’s 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 the Company’s contractual obligations arising out of the research or clinical testing of the Company’s compounds or drug 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 the Company, to violations of law by the Company or to certain breaches of the Company’s contractual obligations. The indemnification provisions appearing in the Company’s collaboration agreements are similar to those for the other agreements discussed above, but in addition provide some limited indemnification for its collaborator in the event of third-party claims alleging infringement of intellectual property rights. In
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
each of the cases above, the indemnification obligation generally survives the termination of the agreement for some extended period, although the Company believes 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 the Company could be required to make under these provisions is generally unlimited. The Company has purchased insurance policies covering personal injury, property damage and general liability that reduce its exposure for indemnification and would enable it in many cases to recover all or a portion of any future amounts paid. The Company has never paid any material amounts to defend lawsuits or settle claims related to these indemnification provisions. Accordingly, the Company believes the estimated fair value of these indemnification arrangements is minimal.
Other Contingencies
The Company has certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a reserve for contingent liabilities when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated. Other than the Company’s contingent consideration liabilities discussed in Note E, “Fair Value Measurements,” there were no material contingent liabilities accrued as of September 30, 2021 or December 31, 2020.
**M.**Additional Cash Flow Information
The cash, cash equivalents and restricted cash at the beginning and ending of each period presented in the Company’s condensed consolidated statements of cash flows consisted of the following:
| Nine Months Ended September 30, | |||||||||||||||||||||||
| 2021 | 2020 | ||||||||||||||||||||||
| Beginning of period | End of period | Beginning of period | End of period | ||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||
| Cash and cash equivalents | $ | 5,988,187 | $ | 6,275,698 | $ | 3,109,322 | $ | 5,358,087 | |||||||||||||||
| Prepaid expenses and other current assets | 658 | 4,515 | 8,004 | 2,898 | |||||||||||||||||||
| Other assets | — | — | 3,355 | — | |||||||||||||||||||
| Cash, cash equivalents and restricted cash per condensed consolidated statement of cash flows | $ | 5,988,845 | $ | 6,280,213 | $ | 3,120,681 | $ | 5,360,985 |
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