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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
________________________________________________________
FORM 10-Q
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2023
or
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD FROM TO
Commission file number 000-19319
____________________________________________
Vertex Pharmaceuticals Incorporated
(Exact name of registrant as specified in its charter)
Massachusetts
(State or other jurisdiction of incorporation or organization)
50 Northern Avenue, Boston, Massachusetts
(Address of principal executive offices)
04-3039129
(I.R.S. Employer Identification No.)
02210
(Zip Code)
Registrant’s telephone number, including area code (617) 341-6100
____________________________________________
| | | | | | | | | | | | | | |
Securities registered pursuant to Section 12(b) of the Act: |
Title of each class | | Trading Symbol | | Name of each exchange on which registered |
Common Stock, $0.01 Par Value Per Share | | VRTX | | The Nasdaq Global Select Market |
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☒ Accelerated filer ☐ Non-accelerated filer ☐ Smaller reporting company ☐ Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
| | | | | | | | |
Common Stock, par value $0.01 per share | 257,683,184 | Outstanding at October 31, 2023 |
VERTEX PHARMACEUTICALS INCORPORATED
FORM 10-Q
FOR THE QUARTER ENDED SEPTEMBER 30, 2023
TABLE OF CONTENTS
“Vertex,” “we,” “us,” and “our” as used in this Quarterly Report on Form 10-Q refer to Vertex Pharmaceuticals Incorporated, a Massachusetts corporation, and its subsidiaries.
“Vertex®,” “KALYDECO®,” “ORKAMBI®,” “SYMDEKO®,” “SYMKEVI®,” “TRIKAFTA®” and “KAFTRIO®” are registered trademarks of Vertex. Other brands, names and trademarks contained in this Quarterly Report on Form 10-Q are the property of their respective owners.
We use the brand name for our products when we refer to the product that has been approved and with respect to the indications on the approved label. Otherwise, including in discussions of our development programs, we refer to our compounds by their scientific (or generic) name or VX developmental designation.
Part I. Financial Information
Item 1. Financial Statements
VERTEX PHARMACEUTICALS INCORPORATED
Condensed Consolidated Statements of Income
(in millions, except per share amounts)(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
| | | | | | | |
Product revenues, net | $ | 2,483.5 | | | $ | 2,334.3 | | | $ | 7,351.5 | | | $ | 6,628.0 | |
| | | | | | | |
| | | | | | | |
Costs and expenses: | | | | | | | |
Cost of sales | 318.7 | | | 289.4 | | | 894.2 | | | 797.0 | |
Research and development expenses | 810.0 | | | 645.0 | | | 2,338.3 | | | 1,846.2 | |
Acquired in-process research and development expenses | 51.7 | | | 29.0 | | | 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 | | | 4,508.0 | | | 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 | | | (13.0) | | | (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 | $ | 4.01 | | | $ | 3.63 | | | $ | 10.29 | | | $ | 9.78 | |
Diluted | $ | 3.97 | | | $ | 3.59 | | | $ | 10.18 | | | $ | 9.68 | |
Shares used in per share calculations: | | | | | | | |
Basic | 258.0 | | | 256.5 | | | 257.7 | | | 255.8 | |
Diluted | 260.6 | | | 259.5 | | | 260.4 | | | 258.7 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
VERTEX PHARMACEUTICALS INCORPORATED
Condensed Consolidated Statements of Comprehensive Income
(in millions)(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
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 | 48.0 | | | 58.8 | | | 5.9 | | | 128.1 | |
Foreign currency translation adjustment | (5.0) | | | (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 | | | $ | 2,647.0 | | | $ | 2,584.8 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
VERTEX PHARMACEUTICALS INCORPORATED
Condensed Consolidated Balance Sheets
(in millions, except share data)(unaudited)
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Assets | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 11,110.2 | | | $ | 10,504.0 | |
Marketable securities | 818.0 | | | 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 | 1,124.0 | | | 1,108.4 | |
Goodwill | 1,088.0 | | | 1,088.0 | |
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 | 1,700.0 | | | 112.2 | |
Other assets | 475.2 | | | 409.6 | |
Total assets | $ | 21,726.2 | | | $ | 18,150.9 | |
Liabilities and Shareholders’ Equity | | | |
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 | — | | | — | |
Shareholders’ equity: | | | |
Preferred stock, $0.01 par value; 1,000,000 shares authorized; none issued and outstanding | — | | | — | |
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) | | | 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 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
VERTEX PHARMACEUTICALS INCORPORATED
Condensed Consolidated Statements of Shareholders’ Equity
(in millions)(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended |
| Common Stock | | Additional Paid-in Capital | | Accumulated Other Comprehensive Income (Loss) | | Retained Earnings | | Total Shareholders’ Equity |
| Shares | | Amount | | | | |
Balance at June 30, 2022 | 256.0 | | | $ | 2.6 | | | $ | 7,100.0 | | | $ | 57.5 | | | $ | 4,773.4 | | | $ | 11,933.5 | |
Other comprehensive income, net of tax | — | | | — | | | — | | | 40.1 | | | — | | | 40.1 | |
Net income | — | | | — | | | — | | | — | | | 930.5 | | | 930.5 | |
| | | | | | | | | | | |
Common stock withheld for employee tax obligations | (0.2) | | | (0.0) | | | (48.0) | | | — | | | — | | | (48.0) | |
Issuance of common stock under benefit plans | 0.8 | | | 0.0 | | | 38.2 | | | — | | | — | | | 38.2 | |
Stock-based compensation expense | — | | | — | | | 135.3 | | | — | | | — | | | 135.3 | |
Balance at September 30, 2022 | 256.6 | | | $ | 2.6 | | | $ | 7,225.5 | | | $ | 97.6 | | | $ | 5,703.9 | | | $ | 13,029.6 | |
| | | | | | | | | | | |
Balance at June 30, 2023 | 257.8 | | | $ | 2.6 | | | $ | 7,369.1 | | | $ | (39.8) | | | $ | 8,138.3 | | | $ | 15,470.2 | |
Other comprehensive income, net of tax | — | | | — | | | — | | | 36.8 | | | — | | | 36.8 | |
Net income | — | | | — | | | — | | | — | | | 1,035.3 | | | 1,035.3 | |
Repurchase of common stock | (0.4) | | | (0.0) | | | (123.0) | | | — | | | — | | | (123.0) | |
Common stock withheld for employee tax obligations | (0.1) | | | (0.0) | | | (53.2) | | | — | | | — | | | (53.2) | |
Issuance of common stock under benefit plans | 0.5 | | | 0.0 | | | 15.0 | | | — | | | — | | | 15.0 | |
Stock-based compensation expense | — | | | — | | | 131.7 | | | — | | | — | | | 131.7 | |
Balance at September 30, 2023 | 257.8 | | | $ | 2.6 | | | $ | 7,339.6 | | | $ | (3.0) | | | $ | 9,173.6 | | | $ | 16,512.8 | |
| | | | | | | | | | | |
| Nine Months Ended |
| Common Stock | | Additional Paid-in Capital | | Accumulated Other Comprehensive Income (Loss) | | Retained Earnings | | Total Shareholders’ Equity |
| Shares | | Amount | | | | |
Balance at December 31, 2021 | 254.5 | | | $ | 2.5 | | | $ | 6,880.8 | | | $ | 15.9 | | | $ | 3,200.8 | | | $ | 10,100.0 | |
Other comprehensive income, net of tax | — | | | — | | | — | | | 81.7 | | | — | | | 81.7 | |
Net income | — | | | — | | | — | | | — | | | 2,503.1 | | | 2,503.1 | |
| | | | | | | | | | | |
Common stock withheld for employee tax obligations | (0.7) | | | (0.0) | | | (169.9) | | | — | | | — | | | (169.9) | |
Issuance of common stock under benefit plans | 2.8 | | | 0.1 | | | 135.2 | | | — | | | — | | | 135.3 | |
Stock-based compensation expense | — | | | — | | | 379.4 | | | — | | | — | | | 379.4 | |
Balance at September 30, 2022 | 256.6 | | | $ | 2.6 | | | $ | 7,225.5 | | | $ | 97.6 | | | $ | 5,703.9 | | | $ | 13,029.6 | |
| | | | | | | | | | | |
Balance at December 31, 2022 | 257.0 | | | $ | 2.6 | | | $ | 7,386.5 | | | $ | 0.8 | | | $ | 6,522.8 | | | $ | 13,912.7 | |
Other comprehensive loss, net of tax | — | | | — | | | — | | | (3.8) | | | — | | | (3.8) | |
Net income | — | | | — | | | — | | | — | | | 2,650.8 | | | 2,650.8 | |
Repurchase of common stock | (0.9) | | | (0.0) | | | (284.1) | | | — | | | — | | | (284.1) | |
Common stock withheld for employee tax obligations | (0.7) | | | (0.0) | | | (222.9) | | | — | | | — | | | (222.9) | |
Issuance of common stock under benefit plans | 2.4 | | | 0.0 | | | 85.7 | | | — | | | — | | | 85.7 | |
Stock-based compensation expense | — | | | — | | | 374.4 | | | — | | | — | | | 374.4 | |
Balance at September 30, 2023 | 257.8 | | | $ | 2.6 | | | $ | 7,339.6 | | | $ | (3.0) | | | $ | 9,173.6 | | | $ | 16,512.8 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
VERTEX PHARMACEUTICALS INCORPORATED
Condensed Consolidated Statements of Cash Flows
(in millions)(unaudited)
| | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2023 | | 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) | | | (424.0) | |
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 | (2,798.0) | | | (417.8) | |
Sales and maturities of available-for-sale debt securities | 621.0 | | | 435.9 | |
Purchases of property and equipment | (142.3) | | | (171.1) | |
Sale of equity securities | 95.1 | | | — | |
Investment in equity securities and notes receivable | (31.0) | | | (47.8) | |
Payment to acquire ViaCyte, Inc., net of cash acquired | — | | | (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) | | | — | |
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) | | | (70.0) | |
Net increase in cash, cash equivalents and restricted cash | 604.6 | | | 2,376.9 | |
Cash, cash equivalents and restricted cash—beginning of period | 10,512.0 | | | 6,800.1 | |
Cash, cash equivalents and restricted cash—end of period | $ | 11,116.6 | | | $ | 9,177.0 | |
| | | |
Supplemental disclosure of cash flow information: | | | |
Cash paid for income taxes | $ | 919.1 | | | $ | 840.1 | |
Cash paid for interest | $ | 32.6 | | | $ | 41.1 | |
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,” “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.
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, |
| 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.
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
C.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
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
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-
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
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.”
D.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 | |
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 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.
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
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.
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
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.
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
F.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 Unrealized Gains | | Gross Unrealized Losses | | Fair Value | | Amortized Cost | | Gross Unrealized Gains | | Gross Unrealized Losses | | 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.
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
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.
G.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 | |
H.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 to eighteen months. We recognize realized gains and losses for the effective portion of such contracts in “Product revenues, net” in our
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
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.
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
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.
VERTEX PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements (unaudited)
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 | | | $ | — | | | $ | |