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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
| | | | | |
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2024
or
| | | | | |
o | 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: 001-12400
INCYTE CORPORATION
(Exact name of registrant as specified in its charter)
| | | | | |
Delaware | 94-3136539 |
(State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
| |
1801 Augustine Cut-Off Wilmington, DE 19803 | 19803 |
(Address of principal executive offices) | (Zip Code) |
(302) 498-6700
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| | | | | | | | | | | | | | |
Title of each class | | Trading Symbol(s) | | Name of exchange on which registered |
Common Stock, $.001 par value per share | | INCY | | The Nasdaq Stock Market LLC |
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. x Yes o 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). x Yes o 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 o |
| |
Non-accelerated filer o | Smaller reporting company o |
| |
| Emerging growth company o |
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. o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). o Yes x No
The number of outstanding shares of the registrant’s Common Stock, $.001 par value, was 192,650,249 as of October 22, 2024.
INCYTE CORPORATION
INDEX
PART I: FINANCIAL INFORMATION
Item 1. Financial Statements
INCYTE CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except number of shares and par value)
| | | | | | | | | | | |
| September 30, 2024 | | December 31, 2023* |
| (unaudited) | | |
ASSETS | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 1,304,109 | | | $ | 3,213,376 | |
Marketable securities—available-for-sale (amortized cost $463,921 and $442,816 as of September 30, 2024 and December 31, 2023, respectively; allowance for credit losses $0 as of September 30, 2024 and December 31, 2023) | 467,235 | | | 442,667 | |
Short term equity investments | 3,344 | | | — | |
Accounts receivable | 758,450 | | | 743,557 | |
Inventory | 70,442 | | | 62,972 | |
Prepaid expenses and other current assets | 205,128 | | | 182,830 | |
Total current assets | 2,808,708 | | | 4,645,402 | |
| | | |
Restricted cash | 1,737 | | | 1,845 | |
Long term equity investments | 27,566 | | | 187,716 | |
Inventory | 297,974 | | | 206,965 | |
Property and equipment, net | 773,102 | | | 751,513 | |
Finance lease right-of-use assets, net | 25,072 | | | 25,535 | |
Other intangible assets, net | 119,994 | | | 123,545 | |
Goodwill | 155,593 | | | 155,593 | |
Deferred income tax asset | 762,310 | | | 631,886 | |
Other assets, net | 40,378 | | | 52,107 | |
Total assets | $ | 5,012,434 | | | $ | 6,782,107 | |
| | | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | | | |
Current liabilities: | | | |
Accounts payable | $ | 178,710 | | | $ | 109,601 | |
Accrued compensation | 150,722 | | | 153,348 | |
Accrued and other current liabilities | 1,127,951 | | | 935,569 | |
Finance lease liabilities | 3,932 | | | 3,439 | |
Acquisition-related contingent consideration | 40,335 | | | 38,422 | |
Total current liabilities | 1,501,650 | | | 1,240,379 | |
| | | |
Acquisition-related contingent consideration | 166,665 | | | 173,578 | |
Finance lease liabilities | 28,223 | | | 29,162 | |
Other liabilities | 144,676 | | | 149,151 | |
Total liabilities | 1,841,214 | | | 1,592,270 | |
| | | |
Commitments and contingencies (Note 16) | | | |
| | | |
Stockholders’ equity: | | | |
Preferred stock, $0.001 par value; 5,000,000 shares authorized; none issued or outstanding | — | | | — | |
Common stock, $0.001 par value; 400,000,000 shares authorized; 192,798,328 and 224,286,862 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively | 192 | | | 224 | |
Additional paid-in capital | 4,429,466 | | | 5,016,122 | |
Accumulated other comprehensive income | 15,655 | | | 13,106 | |
(Accumulated deficit) retained earnings | (1,274,093) | | | 160,385 | |
Total stockholders’ equity | 3,171,220 | | | 5,189,837 | |
Total liabilities and stockholders’ equity | $ | 5,012,434 | | | $ | 6,782,107 | |
*The condensed consolidated balance sheet at December 31, 2023 has been derived from the audited consolidated financial statements at that date.
See accompanying notes.
INCYTE CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share amounts)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Revenues: | | | | | | | |
Product revenues, net | $ | 962,992 | | | $ | 783,197 | | | $ | 2,599,481 | | | $ | 2,303,439 | |
Product royalty revenues | 156,879 | | | 130,828 | | | 420,038 | | | 373,869 | |
Milestone and contract revenues | 18,000 | | | 5,000 | | | 43,000 | | | 5,000 | |
Total revenues | 1,137,871 | | | 919,025 | | | 3,062,519 | | | 2,682,308 | |
| | | | | | | |
Costs, expenses and other: | | | | | | | |
Cost of product revenues (including definite-lived intangible amortization) | 85,993 | | | 60,091 | | | 223,583 | | | 185,239 | |
Research and development | 573,174 | | | 375,709 | | | 2,140,814 | | | 1,183,100 | |
Selling, general and administrative | 309,209 | | | 267,893 | | | 915,447 | | | 867,428 | |
Loss (gain) on change in fair value of acquisition-related contingent consideration | 23,410 | | | (426) | | | 23,847 | | | 14,144 | |
Loss and (profit) sharing under collaboration agreements | — | | | 1,053 | | | (1,025) | | | (858) | |
Total costs, expenses and other | 991,786 | | | 704,320 | | | 3,302,666 | | | 2,249,053 | |
| | | | | | | |
Income (loss) from operations | 146,085 | | | 214,705 | | | (240,147) | | | 433,255 | |
Interest income and other, net | 24,195 | | | 46,371 | | | 118,708 | | | 121,912 | |
Interest expense | (774) | | | (623) | | | (1,861) | | | (1,747) | |
Realized and unrealized (loss) gain on equity investments | (12,982) | | | (26,654) | | | 126,206 | | | 9,839 | |
Income before provision for income taxes | 156,524 | | | 233,799 | | | 2,906 | | | 563,259 | |
Provision for income taxes | 50,068 | | | 62,530 | | | 171,503 | | | 166,739 | |
Net income (loss) | $ | 106,456 | | | $ | 171,269 | | | $ | (168,597) | | | $ | 396,520 | |
| | | | | | | |
Net income (loss) per share: | | | | | | | |
Basic | $ | 0.55 | | | $ | 0.76 | | | $ | (0.80) | | | $ | 1.77 | |
Diluted | $ | 0.54 | | | $ | 0.76 | | | $ | (0.80) | | | $ | 1.76 | |
| | | | | | | |
Shares used in computing net income (loss) per share: | | | | | | | |
Basic | 192,629 | | 224,078 | | 211,763 | | 223,428 |
Diluted | 195,838 | | 226,167 | | 211,763 | | 225,756 |
See accompanying notes.
INCYTE CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(unaudited, in thousands)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Net income (loss) | $ | 106,456 | | | $ | 171,269 | | | $ | (168,597) | | | $ | 396,520 | |
| | | | | | | |
Other comprehensive income (loss): | | | | | | | |
Foreign currency translation gain (loss) | 15,228 | | | (4,855) | | | (2,185) | | | 3,594 | |
Unrealized gain on marketable securities, net of tax | 5,463 | | | 768 | | | 3,463 | | | 3,677 | |
Defined benefit pension gain, net of tax | 384 | | | 175 | | | 1,271 | | | 554 | |
Other comprehensive income (loss) | 21,075 | | | (3,912) | | | 2,549 | | | 7,825 | |
| | | | | | | |
Comprehensive income (loss) | $ | 127,531 | | | $ | 167,357 | | | $ | (166,048) | | | $ | 404,345 | |
See accompanying notes.
INCYTE CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(unaudited, in thousands, except number of shares)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-in Capital | | Accumulated Other Comprehensive Income | | Retained Earnings (Accumulated Deficit) | | Total Stockholders’ Equity |
Balances at January 1, 2024 | $ | 224 | | | $ | 5,016,122 | | | $ | 13,106 | | | $ | 160,385 | | | $ | 5,189,837 | |
Issuance of 245,228 shares of Common Stock upon exercise of stock options and settlement of employee restricted stock units, net of shares withheld for taxes | — | | | (5,697) | | | — | | | — | | | (5,697) | |
Issuance of 1,359 shares of Common Stock for services rendered | — | | | 80 | | | — | | | — | | | 80 | |
Stock compensation | — | | | 59,781 | | | — | | | — | | | 59,781 | |
Other comprehensive loss | — | | | — | | | (19,278) | | | — | | | (19,278) | |
Net income | — | | | — | | | — | | | 169,548 | | | 169,548 | |
Balance at March 31, 2024 | $ | 224 | | | $ | 5,070,286 | | | $ | (6,172) | | | $ | 329,933 | | | $ | 5,394,271 | |
Issuance of 71,769 shares of Common Stock upon exercise of stock options and settlement of employee restricted stock units and performance shares, net of shares withheld for taxes and 291,735 shares of Common Stock under the ESPP | — | | | 13,792 | | | — | | | — | | | 13,792 | |
Issuance of 1,345 shares of Common Stock for services rendered | — | | | 80 | | | — | | | — | | | 80 | |
Stock compensation | — | | | 56,637 | | | — | | | — | | | 56,637 | |
Repurchases of common stock | (33) | | | (758,061) | | | — | | | (1,265,778) | | | (2,023,872) | |
Other comprehensive income | — | | | — | | | 752 | | | — | | | 752 | |
Net loss | — | | | — | | | — | | | (444,601) | | | (444,601) | |
Balances at June 30, 2024 | $ | 191 | | | $ | 4,382,734 | | | $ | (5,420) | | | $ | (1,380,446) | | | $ | 2,997,059 | |
Issuance of 1,060,300 shares of Common Stock upon exercise of stock options and settlement of employee restricted stock units, net of shares withheld for taxes | 1 | | | (31,270) | | | — | | | — | | | (31,269) | |
Issuance of 1,242 shares of Common Stock for services rendered | — | | | 80 | | | — | | | — | | | 80 | |
Stock compensation | — | | | 77,922 | | | — | | | — | | | 77,922 | |
Repurchases of common stock | — | | | — | | | — | | | (103) | | | (103) | |
Other comprehensive income | — | | | — | | | 21,075 | | | — | | | 21,075 | |
Net income | — | | | — | | | — | | | 106,456 | | | 106,456 | |
Balances at September 30, 2024 | $ | 192 | | | $ | 4,429,466 | | | $ | 15,655 | | | $ | (1,274,093) | | | $ | 3,171,220 | |
INCYTE CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (CONTINUED)
(unaudited, in thousands, except number of shares)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-in Capital | | Accumulated Other Comprehensive Income | | Accumulated Deficit | | Total Stockholders’ Equity |
Balances at January 1, 2023 | $ | 223 | | | $ | 4,792,041 | | | $ | 15,069 | | | $ | (437,214) | | | $ | 4,370,119 | |
Issuance of 313,995 shares of Common Stock upon exercise of stock options and settlement of employee restricted stock units, net of shares withheld for taxes | — | | | 11,235 | | | — | | | — | | | 11,235 | |
Issuance of 1,073 shares of Common Stock for services rendered | — | | | 80 | | | — | | | — | | | 80 | |
Stock compensation | — | | | 53,558 | | | — | | | — | | | 53,558 | |
Other comprehensive income | — | | | — | | | 5,873 | | | — | | | 5,873 | |
Net income | — | | | — | | | — | | | 21,703 | | | 21,703 | |
Balances at March 31, 2023 | $ | 223 | | | $ | 4,856,914 | | | $ | 20,942 | | | $ | (415,511) | | | $ | 4,462,568 | |
Issuance of 59,093 shares of Common Stock upon exercise of stock options and settlement of employee restricted stock units and performance shares, net of shares withheld for taxes and 216,168 shares of Common Stock under the ESPP | — | | | 13,704 | | | — | | | — | | | 13,704 | |
Issuance of 1,282 shares of Common Stock for services rendered | — | | | 80 | | | — | | | — | | | 80 | |
Stock compensation | — | | | 54,928 | | | — | | | — | | | 54,928 | |
Other comprehensive income | — | | | — | | | 5,864 | | | — | | | 5,864 | |
Net income | — | | | — | | | — | | | 203,548 | | | 203,548 | |
Balances at June 30, 2023 | $ | 223 | | | $ | 4,925,626 | | | $ | 26,806 | | | $ | (211,963) | | | $ | 4,740,692 | |
Issuance of 762,231 shares of Common Stock upon exercise of stock options and settlement of employee restricted stock units, net of shares withheld for taxes | 1 | | | (24,682) | | | — | | | — | | | (24,681) | |
Issuance of 1,278 shares of Common Stock for services rendered | — | | | 80 | | | — | | | — | | | 80 | |
Stock compensation | — | | | 47,999 | | | — | | | — | | | 47,999 | |
Other comprehensive loss | — | | | — | | | (3,912) | | | — | | | (3,912) | |
Net income | — | | | — | | | — | | | 171,269 | | | 171,269 | |
Balances at September 30, 2023 | $ | 224 | | | $ | 4,949,023 | | | $ | 22,894 | | | $ | (40,694) | | | $ | 4,931,447 | |
See accompanying notes.
INCYTE CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited, in thousands)
| | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2024 | | 2023 |
Cash flows from operating activities: | | | |
Net (loss) income | $ | (168,597) | | | $ | 396,520 | |
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities: | | | |
Depreciation and amortization | 66,515 | | | 60,898 | |
Stock-based compensation | 194,340 | | | 155,899 | |
Deferred income taxes | (85,609) | | | (92,919) | |
Other, net | (4,824) | | | (543) | |
Realized and unrealized gain on equity investments | (126,206) | | | (9,839) | |
Loss on change in fair value of acquisition-related contingent consideration | 23,847 | | | 14,144 | |
Changes in operating assets and liabilities: | | | |
Accounts receivable | (14,893) | | | (12,384) | |
Prepaid expenses and other assets | (55,381) | | | (62,081) | |
Inventory | (93,352) | | | (77,193) | |
Accounts payable | 69,109 | | | (138,135) | |
Accrued and other liabilities | 149,170 | | | 114,391 | |
Net cash (used in) provided by operating activities | (45,881) | | | 348,758 | |
Cash flows from investing activities: | | | |
Purchase of long term investments | — | | | (10,000) | |
Sale of equity investments | 282,866 | | | 45 | |
Capital expenditures | (68,879) | | | (30,219) | |
Payments for intangible assets | (13,900) | | | (15,000) | |
Purchases of marketable securities | (228,986) | | | (222,228) | |
Sale and maturities of marketable securities | 207,881 | | | 224,225 | |
Net cash provided by (used in) investing activities | 178,982 | | | (53,177) | |
Cash flows from financing activities: | | | |
Repurchases of common stock | (2,004,790) | | | — | |
Proceeds from issuance of common stock under stock plans | 16,242 | | | 28,319 | |
Tax withholdings related to restricted and performance share vesting | (39,416) | | | (28,061) | |
Payment of finance lease liabilities | (2,761) | | | (2,523) | |
Payment of contingent consideration | (11,216) | | | (18,114) | |
Net cash used in financing activities | (2,041,941) | | | (20,379) | |
Effect of exchange rates on cash, cash equivalents, and restricted cash | (535) | | | 625 | |
Net (decrease) increase in cash, cash equivalents, and restricted cash | (1,909,375) | | | 275,827 | |
Cash, cash equivalents, and restricted cash at beginning of period | 3,215,221 | | | 2,953,120 | |
Cash, cash equivalents, and restricted cash at end of period | $ | 1,305,846 | | | $ | 3,228,947 | |
Supplemental Schedule of Cash Flow Information | | | |
Income taxes paid | $ | 302,860 | | | $ | 253,180 | |
Unpaid purchases of property and equipment | $ | 3,538 | | | $ | 11 | |
Unpaid excise tax on repurchase of common stock | $ | 19,185 | | | $ | — | |
Leased assets obtained in exchange for new operating lease liabilities | $ | 2,436 | | | $ | 5,275 | |
Leased assets obtained in exchange for new finance lease liabilities | $ | 1,959 | | | $ | 1,176 | |
See accompanying notes.
INCYTE CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2024
(Unaudited)
Note 1. Organization and Business
Incyte Corporation (including its subsidiaries, “Incyte,” “we,” “us,” or “our”) is a biopharmaceutical company focused on developing and commercializing proprietary therapeutics. Our portfolio includes compounds in various stages, ranging from preclinical to late stage development, and commercialized products JAKAFI® (ruxolitinib), ICLUSIG® (ponatinib), PEMAZYRE® (pemigatinib), OPZELURA® (ruxolitinib cream), MINJUVI® (tafasitamab), MONJUVI® (tafasitamab-cxix), and ZYNYZ® (retifanlimab-dlwr), as well as NIKTIMVO™ (axatilimab-csfr), which was approved for medical use in the United States in August 2024 and will be co-commercialized. Our operations are treated as one operating segment.
Note 2. Summary of Significant Accounting Policies
Basis of presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. The condensed consolidated balance sheet as of September 30, 2024, the condensed consolidated statements of operations, comprehensive income (loss), and stockholders’ equity for the three and nine months ended September 30, 2024 and 2023, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2024 and 2023, are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which we consider necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The condensed consolidated balance sheet at December 31, 2023 has been derived from our audited consolidated financial statements.
Although we believe that the disclosures in these financial statements are adequate to make the information presented not misleading, certain information and footnote information normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”).
Results for any interim period are not necessarily indicative of results for any future interim period or for the entire year. The accompanying financial statements should be read in conjunction with the financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2023.
Principles of Consolidation. The condensed consolidated financial statements include the accounts of Incyte Corporation and our wholly owned subsidiaries. All inter-company accounts, transactions, and profits have been eliminated in consolidation.
Use of Estimates. The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.
Recent Accounting Pronouncements and Regulatory Updates
In November 2023, the Financial Accounting Standards Board (the “FASB”) issued ASU No. 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures.” This amended guidance applies to all public entities and aims to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses, to enable investors to develop more decision-useful financial analyses. This guidance is effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. We are currently evaluating the impact that ASU No. 2023-07 will have on our annual consolidated financial statements.
In December 2023, the FASB issued ASU No. 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” This amended guidance applies to all entities and broadly aims to enhance the transparency and decision usefulness of income tax disclosures. For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2024. Early adoption is permitted for any annual periods for which financial statements have not been issued or made available for issuance. We are currently evaluating the impact that ASU No. 2023-09 will have on our consolidated financial statements.
In March 2024, the SEC issued Release Nos. 33-11275; 34-99678 “The Enhancement and Standardization of Climate-Related Disclosures for Investors” to require public companies to provide certain climate-related information in their registration statements and annual reports. The compliance dates for the rules amended by this release begin in fiscal year 2025 for large accelerated filers. On April 4, 2024, the SEC issued an order staying the newly adopted rules. We are currently evaluating the impact of this release on our financial disclosures.
Note 3. Revenues
Revenues are recognized under guidance within ASC 606, Revenue from Contracts with Customers. The following table presents our disaggregated revenue for the periods presented (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
JAKAFI revenues, net | $ | 741,181 | | | $ | 636,252 | | | $ | 2,018,993 | | | $ | 1,898,605 | |
OPZELURA revenues, net | 139,272 | | | 91,836 | | | 346,691 | | | 228,621 | |
ICLUSIG revenues, net | 29,745 | | | 27,721 | | | 86,950 | | | 84,493 | |
PEMAZYRE revenues, net | 20,661 | | | 18,942 | | | 58,606 | | | 62,989 | |
MINJUVI/MONJUVI revenues, net | 31,439 | | | 8,348 | | | 86,429 | | | 28,063 | |
ZYNYZ revenues, net | 694 | | | 98 | | | 1,812 | | | 668 | |
Total product revenues, net | 962,992 | | | 783,197 | | | 2,599,481 | | | 2,303,439 | |
JAKAVI product royalty revenues | 115,741 | | | 96,551 | | | 304,653 | | | 263,691 | |
OLUMIANT product royalty revenues | 34,796 | | | 29,615 | | | 97,087 | | | 95,779 | |
TABRECTA product royalty revenues | 5,928 | | | 4,139 | | | 16,460 | | | 13,115 | |
PEMAZYRE product royalty revenues | 414 | | | 523 | | | 1,838 | | | 1,284 | |
Total product royalty revenues | 156,879 | | | 130,828 | | | 420,038 | | | 373,869 | |
Milestone and contract revenues | 18,000 | | | 5,000 | | | 43,000 | | | 5,000 | |
Total revenues | $ | 1,137,871 | | | $ | 919,025 | | | $ | 3,062,519 | | | $ | 2,682,308 | |
For further information on the MINJUVI/MONJUVI revenues, refer to Note 6, and for further information on our revenue-generating contracts, refer to Note 8.
Note 4. Fair Value of Financial Instruments
The following is a summary of our marketable security portfolio for the periods presented (in thousands):
| | | | | | | | | | | | | | | | | |
| Amortized Cost | | Net Unrealized Gains (Losses) | | Estimated Fair Value |
September 30, 2024 | | | | | |
Debt securities (government) | $ | 463,921 | | | $ | 3,314 | | | $ | 467,235 | |
| | | | | |
December 31, 2023 | | | | | |
Debt securities (government) | $ | 442,816 | | | $ | (149) | | | $ | 442,667 | |
Our available-for-sale debt securities generally have contractual maturity dates of between 12 to 18 months. Debt security assets were assessed for risk of expected credit losses. As of September 30, 2024 and December 31, 2023, the available-for-sale debt securities were held in U.S.-government backed securities and in Treasury bonds and were assessed on an individual security basis to have a de minimis risk of credit loss.
Fair Value Measurements
FASB accounting guidance defines fair value as the price that would be received to sell an asset or paid to transfer a liability (“the exit price”) in an orderly transaction between market participants at the measurement date. The standard outlines a valuation framework and creates a fair value hierarchy in order to increase the consistency and comparability of fair value measurements and the related disclosures. In determining fair value we use quoted prices and observable inputs. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of us. The fair value hierarchy is broken down into three levels based on the source of inputs as follows:
Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities.
Level 2—Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities.
Level 3—Valuations based on inputs that are unobservable and models that are significant to the overall fair value measurement.
Recurring Fair Value Measurements
Our marketable securities consist of investments in U.S. government debt securities that are classified as available-for-sale. Additionally, we have short term equity investments, which we intended to sell within one year, classified as Level 1 that were valued using their respective closing stock prices on The Nasdaq Stock Market.
At September 30, 2024 and December 31, 2023, our Level 2 U.S. government debt securities were valued using readily available pricing sources which utilize market observable inputs, including the current interest rate and other characteristics for similar types of investments. Our long term equity investments classified as Level 1 were valued using their respective closing stock prices on The Nasdaq Stock Market. We did not experience any transfers of financial instruments between the fair value hierarchy levels during the nine months ended September 30, 2024.
The following fair value hierarchy table presents information about each major category of our financial assets measured at fair value on a recurring basis (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Fair Value Measurement at Reporting Date Using: | | |
| Quoted Prices in Active Markets for Identical Assets (Level 1) | | Significant Other Observable Inputs (Level 2) | | Significant Unobservable Inputs (Level 3) | | Balance as of September 30, 2024 |
Cash and cash equivalents | $ | 1,304,109 | | | $ | — | | | $ | — | | | $ | 1,304,109 | |
Debt securities (government) | — | | | 467,235 | | | — | | | 467,235 | |
Short term equity investments (Note 8) | 3,344 | | | — | | | — | | | 3,344 | |
Long term equity investments (Note 8) | 27,566 | | | — | | | — | | | 27,566 | |
Total assets | $ | 1,335,019 | | | $ | 467,235 | | | $ | — | | | $ | 1,802,254 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Fair Value Measurement at Reporting Date Using: | | |
| Quoted Prices in Active Markets for Identical Assets (Level 1) | | Significant Other Observable Inputs (Level 2) | | Significant Unobservable Inputs (Level 3) | | Balance as of December 31, 2023 |
Cash and cash equivalents | $ | 3,213,376 | | | $ | — | | | $ | — | | | $ | 3,213,376 | |
Debt securities (government) | — | | | 442,667 | | | — | | | 442,667 | |
Long term equity investments (Note 8) | 187,716 | | | — | | | — | | | 187,716 | |
Total assets | $ | 3,401,092 | | | $ | 442,667 | | | $ | — | | | $ | 3,843,759 | |
The following fair value hierarchy table presents information about each major category of our financial liabilities measured at fair value on a recurring basis as (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Fair Value Measurement at Reporting Date Using: | | |
| Quoted Prices in Active Markets for Identical Liabilities (Level 1) | | Significant Other Observable Inputs (Level 2) | | Significant Unobservable Inputs (Level 3) | | Balance as of September 30, 2024 |
Acquisition-related contingent consideration | $ | — | | | $ | — | | | $ | 207,000 | | | $ | 207,000 | |
Total liabilities | $ | — | | | $ | — | | | $ | 207,000 | | | $ | 207,000 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Fair Value Measurement at Reporting Date Using: | | |
| Quoted Prices in Active Markets for Identical Liabilities (Level 1) | | Significant Other Observable Inputs (Level 2) | | Significant Unobservable Inputs (Level 3) | | Balance as of December 31, 2023 |
Acquisition-related contingent consideration | $ | — | | | $ | — | | | $ | 212,000 | | | $ | 212,000 | |
Total liabilities | $ | — | | | $ | — | | | $ | 212,000 | | | $ | 212,000 | |
The following is a roll forward of our Level 3 liabilities (in thousands):
| | | | | |
| 2024 |
Balance at January 1, | $ | 212,000 | |
Contingent consideration earned during the period but not yet paid | (19,303) | |
Payments made during the period | (9,544) | |
Change in fair value of contingent consideration | 23,847 | |
Balance at September 30, | $ | 207,000 | |
The initial fair value of the contingent consideration was determined on the date of acquisition, June 1, 2016, using an income approach based on projected future net revenues of ICLUSIG in the European Union and other countries for the approved third line treatment over 18 years, and discounted to present value at a rate of 10%. The fair value of the contingent consideration is remeasured each reporting period, with changes in fair value recorded in the condensed consolidated statements of operations. The valuation inputs utilized to estimate the fair value of the contingent consideration as of September 30, 2024 and December 31, 2023 included a discount rate of 10% and updated projections of future net revenues of ICLUSIG in the European Union and other countries for the approved third line treatment. The change in fair value of the contingent consideration during the three and nine months ended September 30, 2024 was due primarily to fluctuations in foreign currency exchange rates impacting future revenue projections of ICLUSIG and the passage of time.
We generally make payments to Takeda Pharmaceutical Company Limited quarterly based on the royalties or any additional milestone payments earned in the previous quarter. At September 30, 2024 and December 31, 2023, contingent consideration earned but not yet paid was $19.3 million and $10.3 million, respectively, and was included in accrued and other current liabilities on the condensed consolidated balance sheets.
Note 5. Concentration of Credit Risk and Current Expected Credit Losses
In November 2009, we entered into a collaboration and license agreement with Novartis Pharmaceutical International Ltd. (“Novartis”). In December 2009, we entered into a license, development and commercialization agreement with Eli Lilly and Company (“Lilly”). The above collaboration partners comprised, in aggregate, 21% and 20% of the accounts receivable balance as of September 30, 2024 and December 31, 2023, respectively. For further information relating to these collaboration and license agreements, refer to Note 8.
In November 2011, we began commercialization and distribution of JAKAFI and in October 2021, we began commercialization and distribution of OPZELURA. Our product revenues are concentrated in a number of customers for these products. The concentration of credit risk related to our JAKAFI and OPZELURA product revenues is as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| Percentage of Total Net Product Revenues for the Three Months Ended | | Percentage of Total Net Product Revenues for the Nine Months Ended |
| September 30, | | September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Customer A | 15 | % | | 17 | % | | 15 | % | | 17 | % |
Customer B | 10 | % | | 10 | % | | 10 | % | | 10 | % |
Customer C | 20 | % | | 17 | % | | 19 | % | | 18 | % |
Customer D | 8 | % | | 9 | % | | 8 | % | | 10 | % |
Customer E | 13 | % | | 12 | % | | 13 | % | | 11 | % |
Customer F | 10 | % | | 10 | % | | 10 | % | | 9 | % |
We are exposed to risks associated with extending credit to customers related to the sale of products. Customers A, B, C, D, E and F comprised, in aggregate, 53% and 48% of the accounts receivable balance as of September 30, 2024 and December 31, 2023, respectively. The concentration of credit risk relating to our other product revenues or accounts receivable is not significant.
We assessed our collaborative and customer receivable assets as of September 30, 2024 according to our accounting policy for applying reserves for expected credit losses, noting minimal history of uncollectible receivables and the continued perceived creditworthiness of our third party sales relationships, upon which the expected credit losses were considered de minimis. As of September 30, 2024 and December 31, 2023, we had no allowance for doubtful accounts.
Note 6. Acquisitions
Tafasitamab
On February 5, 2024, we entered into a purchase agreement with MorphoSys AG and MorphoSys US Inc., a wholly-owned subsidiary of MorphoSys AG (together with MorphoSys AG, “MorphoSys”), under which we gained exclusive global rights to tafasitamab, a humanized Fc-modified CD19-targeting immunotherapy marketed in the United States as MONJUVI (tafasitamab-cxix) and outside of the United States as MINJUVI (tafasitamab). We previously had the rights to tafasitamab outside of the United States under a January 2020 collaboration and license agreement with MorphoSys, which has now been terminated; therefore, this new agreement gave us all of the remaining global rights to tafasitamab. Under the terms of the purchase agreement, we made a payment of $25.0 million to MorphoSys and gained global development and commercialization rights for tafasitamab along with MONJUVI inventory. We will recognize revenue and costs for all U.S. commercialization and clinical development and MorphoSys will no longer be eligible to receive future milestone, profit split and royalty payments under the now-terminated collaboration and license agreement.
We evaluated the set of activities and assets acquired under the purchase agreement and concluded that it did not meet the definition of a business because the acquired set did not include a substantive process. Therefore, the transaction was accounted for as an asset acquisition under U.S. GAAP and the total purchase price, inclusive of direct transaction costs, was allocated to the acquired MONJUVI inventory, in accordance with applicable accounting guidance.
Under the purchase agreement, we have also become the successor to MorphoSys under its collaboration and license agreement with Xencor, Inc. (“Xencor”), pursuant to which Xencor granted MorphoSys an exclusive, worldwide license, including the right to sublicense under certain conditions, for tafasitamab. Xencor is entitled to receive up to $186.5 million in future contingent development and regulatory milestones and up to $50.0 million in sales milestones. Furthermore, Xencor is eligible to receive tiered royalties on global net sales of tafasitamab in the single-digit to sub-teen double-digit percentage range. Our royalty obligations continue on a country-by-country basis until the later to occur of the expiration of the last valid claim in the licensed patent covering tafasitamab in such country, or 11 years after the first sale thereof following marketing authorization in such country. The term of the Xencor collaboration agreement will continue until all of our royalty payment obligations have expired, unless terminated earlier. The Xencor collaboration agreement may be terminated by either party upon written notice to the other party immediately in the event of the other party’s insolvency or upon 120 days’ written notice for the other party’s uncured material breach (or upon 30 days’ written notice in the case of a breach of a payment obligation). Moreover, we may terminate the Xencor collaboration agreement without cause upon 90 days’ advance written notice to Xencor. In the event that (i) we terminate this agreement for convenience or (ii) Xencor terminates due to our material breach, our challenge of Xencor’s licensed patents or our insolvency, worldwide rights to develop, manufacture and commercialize licensed products, including tafasitamab, revert back to Xencor.
Escient Pharmaceuticals, Inc. ("Escient")
On May 30, 2024 we acquired all of the outstanding shares of common stock of Escient, a clinical-stage drug development company advancing novel small molecule therapeutics for systemic immune and neuro-immune disorders, for $782.5 million cash consideration, which included Escient's net cash remaining at the close of the transaction, subject to adjustments set forth in the merger agreement.
Escient’s lead molecule, INCB000262 (formerly EP262), is a first-in-class oral Mas-related G protein-coupled receptor X2 (MRGPRX2) antagonist that has the potential to treat a broad range of inflammatory disorders. We accounted for the Escient transaction as an asset acquisition under U.S. GAAP because INCB000262 represents substantially all of the fair value of the gross assets acquired.
In addition to the $782.5 million closing cash consideration per the terms of the merger agreement, we incurred $2.5 million of direct transaction costs that were included in the total consideration to be allocated to the acquired net assets. Of the $785.0 million total consideration, we recognized related compensation expense of $31.5 million associated with the accelerated vesting for certain Escient stock awards in connection with the acquisition on our condensed consolidated statements of operations during the three months ended June 30, 2024.
The following table summarizes allocation of the remaining U.S. GAAP consideration, net of compensation expense, across the net assets acquired (in thousands):
| | | | | |
Cash and cash equivalents | $ | 48,302 | |
Marketable securities | 3,988 | |
Prepaid expenses and other current assets | 1,663 | |
In-process research and development assets | 679,388 | |
Deferred tax asset | 44,811 | |
Other non-current assets | 4,110 | |
Accounts payable and accrued expenses | (26,611) | |
Other current liabilities | (1,022) | |
Non-current liabilities | (1,118) | |
Total U.S. GAAP Consideration (net of compensation expense) | $ | 753,511 | |
In-process research and development (“IPR&D”) assets are related to acquired clinical-stage product candidates: lead candidate, INCB000262, and secondary candidate, INCB000547 (formerly EP547). The fair value of IPR&D assets was based on the present value of future discounted cash flows, which was based on significant estimates. These estimates included the number of potential patients and market prices of future product candidates, costs required to conduct clinical trials, future milestones and royalties payable under acquired license agreements, costs to receive regulatory approval and potentially commercialize product candidates, as well as estimates for probability of success and the discount rate. The concluded allocated fair values for INCB000262 and INCB000547 was $644.8 million and $34.6 million, respectively. As both acquired IPR&D assets do not have an alternative future use at the acquisition date, we recognized the full amount of $679.4 million as research and development expenses on our condensed consolidated statement of operations during the three months ended June 30, 2024.
Note 7. Inventory
Our inventory balance consists of the following (in thousands):
| | | | | | | | | | | |
| September 30, 2024 | | December 31, 2023 |
Raw materials | $ | 35,507 | | | $ | 23,282 | |
Work-in-process | 285,504 | | | 209,793 | |
Finished goods | 47,405 | | | 36,862 | |
Total inventory | $ | 368,416 | | | $ | 269,937 | |
Inventories, stated at the lower of cost and net realizable value, consist of raw materials, work in process and finished goods. At September 30, 2024, $70.4 million of inventory was classified as current on the condensed consolidated balance sheet as we expect this inventory to be consumed for commercial use within the next twelve months. At September 30, 2024, $298.0 million of inventory was classified as non-current on the condensed consolidated balance sheet as we did not expect this inventory to be consumed for commercial use within the next twelve months. We obtain some inventory components from a limited number of suppliers due to technology, availability, price, quality or other considerations. The loss of a supplier, the deterioration of our relationship with a supplier, or any unilateral violation of the contractual terms under which we are supplied components by a supplier could adversely affect our total revenues and gross margins.
We capitalize inventory after regulatory approval as the related costs are expected to be recoverable through the commercialization of the product. Costs incurred prior to regulatory approval are recorded as research and development expense in our statements of operations. At September 30, 2024, inventory with approximately $32.3 million of product costs incurred prior to regulatory approval had not yet been sold. We expect to sell the pre-commercialization inventory over the next 7 to 27 months and, as a result, cost of product revenues will reflect a lower average per unit cost of materials.
Note 8. License Agreements
Novartis
In November 2009, we entered into a Collaboration and License Agreement with Novartis. Under the terms of the agreement, Novartis received exclusive development and commercialization rights outside of the United States to our JAK inhibitor ruxolitinib and certain back-up compounds for hematologic and oncology indications, including all hematological malignancies, solid tumors and myeloproliferative diseases. We retained exclusive development and commercialization rights to JAKAFI (ruxolitinib) in the United States and in certain other indications. Novartis also received worldwide exclusive development and commercialization rights to our MET inhibitor compound capmatinib and certain back-up compounds in all indications.
Under this agreement, we were initially eligible to receive up to $174.0 million for the achievement of development milestones, up to $495.0 million for the achievement of regulatory milestones and up to $500.0 million for the achievement of sales milestones. In addition, we were initially eligible to receive up to $75.0 million of additional potential development and regulatory milestones relating to graft-versus-host-disease (“GVHD”). Since the inception of the agreement through September 30, 2024, we have recognized and received, in the aggregate, $157.0 million for the achievement of development milestones, $345.0 million for the achievement of regulatory milestones, and $200.0 million for the achievement of sales milestones.
We also are eligible to receive tiered, double-digit royalties ranging from the upper-teens to the mid-twenties on future JAKAVI net sales outside of the United States, and tiered, worldwide royalties on TABRECTA net sales that range from 12% to 14%. We are obligated to pay to Novartis tiered royalties in the low single-digits on future JAKAFI net sales within the United States contingent on certain conditions. During the three and nine months ended September 30, 2024, such royalties on net sales within the United States totaled $36.3 million and $93.9 million, respectively, and were reflected in cost of product revenues on the condensed consolidated statements of operations. During the three and nine months ended September 30, 2023, such royalties on net sales within the United States totaled $31.1 million and $88.0 million, respectively, and were reflected in cost of product revenues on the condensed consolidated statements of operations. At September 30, 2024 and December 31, 2023, approximately $469.5 million and $375.6 million, respectively, of accrued royalties were included in accrued and other current liabilities on the condensed consolidated balance sheets, payment of which is dependent on the outcome of a contract dispute with Novartis. Each company is responsible for costs relating to the development and commercialization of ruxolitinib in its respective territories, with costs of collaborative studies shared equally. Novartis is also responsible for all costs relating to the development and commercialization of capmatinib.
We had no milestone and contract revenue under the Novartis agreement for the three and nine months ended September 30, 2024. Milestone and contract revenue under the Novartis agreement was $5.0 million for both the three and nine months ended September 30, 2023. Product royalty revenue related to Novartis net sales of JAKAVI outside of the United States for the three and nine months ended September 30, 2024 was $115.7 million and $304.7 million, respectively. Product royalty revenue related to Novartis net sales of JAKAVI outside of the United States for the three and nine months ended September 30, 2023 was $96.6 million and $263.7 million, respectively. Product royalty revenue related to Novartis net sales of TABRECTA worldwide for the three and nine months ended September 30, 2024 was $5.9 million and $16.5 million, respectively. Product royalty revenue related to Novartis net sales of TABRECTA worldwide for the three and nine months ended September 30, 2023 was $4.1 million and $13.1 million, respectively.
Lilly – Baricitinib
In December 2009, we entered into a License, Development and Commercialization Agreement with Lilly. Under the terms of the agreement, Lilly received exclusive worldwide development and commercialization rights to our JAK inhibitor baricitinib, and certain back-up compounds for inflammatory and autoimmune diseases.
Under this agreement, we were initially eligible to receive up to $150.0 million for the achievement of development milestones, up to $365.0 million for the achievement of regulatory milestones and up to $150.0 million for the achievement of sales milestones. Since the inception of the agreement through September 30, 2024, we have recognized and received, in aggregate, $149.0 million for the achievement of development milestones, $335.0 million for the achievement of regulatory milestones and $50.0 million for the achievement of sales milestones. We are also eligible to receive tiered, double-digit royalties on future global sales with rates ranging up to the mid-twenties if a product is successfully commercialized.
Product royalty revenue related to Lilly net sales of OLUMIANT outside of the United States for the three and nine months ended September 30, 2024 was $34.8 million and $97.1 million, respectively. Product royalty revenue related to Lilly net sales of OLUMIANT outside of the United States for the three and nine months ended September 30, 2023 was $29.6 million and $95.8 million, respectively.
Agenus
In January 2015, we entered into a License, Development and Commercialization Agreement with Agenus Inc. and its wholly-owned subsidiary, 4-Antibody AG (now known as Agenus Switzerland Inc.), which we collectively refer to as Agenus. Under this agreement, which was amended in February 2017, the parties have agreed to collaborate on the discovery of novel immuno-therapeutics using Agenus’ antibody discovery platforms.
Since the inception of the agreement through September 30, 2024, we have paid Agenus milestones totaling $30.0 million, and Agenus is eligible to receive up to an additional $500.0 million in future contingent development, regulatory and commercialization milestones across all programs in the collaboration.
As of September 30, 2024, we held an investment of approximately 0.6 million shares of Agenus Inc. common stock. The fair market value of our equity investment in Agenus Inc. at September 30, 2024 and December 31, 2023 was $3.3 million and $10.0 million, respectively. For the three and nine months ended September 30, 2024, we recorded an unrealized loss of $6.8 million and $6.7 million, respectively, based on the change in fair value of Agenus Inc.’s common stock during the respective periods. For the three and nine months ended September 30, 2023, we recorded an unrealized loss of $5.6 million and $15.3 million, respectively, based on the change in fair value of Agenus Inc.’s common stock during the respective periods.
Merus
In December 2016, we entered into a Collaboration and License Agreement with Merus N.V. (“Merus”). Under this agreement, the parties have agreed to collaborate with respect to the research, discovery and development of bispecific antibodies utilizing Merus’ technology platform. The collaboration encompasses up to ten independent programs.
Since the inception of the agreement through September 30, 2024, we have paid and expensed Merus milestones totaling $10.0 million.
During the three months ended June 30, 2024, we sold approximately 3.0 million of Merus’ common shares for proceeds of $160.6 million. During the three months ended September 30, 2024, we sold our remaining approximately 1.0 million of Merus’ common shares for proceeds of $55.5 million. As of September 30, 2024, we had no remaining investment of Merus’ common shares. The fair market value of our equity investment in Merus at December 31, 2023 was $110.1 million. For the three and nine months ended September 30, 2024, we recorded realized and unrealized losses of $4.1 million and realized and unrealized gains of $106.1 million, respectively, based on the sale of shares and change in fair value of remaining Merus’ common shares during the respective periods. For the three and nine months ended September 30, 2023, we recorded an unrealized loss of $9.1 million and an unrealized gain of $29.5 million, respectively, based on the change in fair value of Merus’ common shares during the respective periods.
MacroGenics
In October 2017, we entered into a Global Collaboration and License Agreement with MacroGenics, Inc. (“MacroGenics”). Under this agreement, we received exclusive development and commercialization rights worldwide to MacroGenics’ INCMGA0012 (formerly MGA012), an investigational monoclonal antibody that inhibits PD-1. Except as set forth in the succeeding sentence, we have sole authority over and bear all costs and expenses in connection with the development and commercialization of INCMGA0012 in all indications, whether as a monotherapy or as part of a combination regimen. MacroGenics has retained the right to develop and commercialize, at its cost and expense, its pipeline assets in combination with INCMGA0012. In addition, MacroGenics has the right to manufacture a portion of both companies’ global clinical and commercial supply needs of INCMGA0012.
In March 2023, we made a $15.0 million regulatory milestone payment to MacroGenics for the FDA approval of ZYNYZ for the treatment of adults with Merkel cell carcinoma. This milestone payment was capitalized as an intangible asset and included in Other intangible assets, net on the condensed consolidated balance sheet as of September 30, 2024, and is being amortized through cost of product revenues over the estimated useful life of 13.5 years.
On July 24, 2024, the parties amended the agreement, and Incyte agreed to pay MacroGenics $100.0 million in exchange for MacroGenics’ agreement that all milestones for squamous cell anal cancer and non-small cell lung cancer have been deemed either achieved or inapplicable and certain future milestones for non-small cell lung cancer were waived. This $100.0 million milestone payment was recorded as research and development expense in our condensed consolidated statements of operations during the three and nine months ended September 30, 2024. Since the inception of the agreement, inclusive of the July 2022 and July 2024 amendments to the agreement, through September 30, 2024, we have paid MacroGenics developmental and regulatory milestones totaling $215.0 million. After these amendments and subsequent payments, MacroGenics will be eligible to receive up to an additional $210.0 million in future contingent development and regulatory milestones, and up to $330.0 million in sales milestones as well as tiered royalties ranging from 15% to 24% of global net sales.
Research and development expenses for the three and nine months ended September 30, 2024 also included $15.5 million and $40.8 million, respectively, of development costs incurred pursuant to the MacroGenics agreement. Research and development expenses for the three and nine months ended September 30, 2023 also included $12.9 million and $42.8 million, respectively, of development costs incurred pursuant to the MacroGenics agreement. At September 30, 2024 and December 31, 2023, a total of $0.9 million and $0.3 million of such costs were included in accrued and other liabilities on the condensed consolidated balance sheets.
MorphoSys
As described in Note 6, on February 5, 2024, we entered into a purchase agreement with MorphoSys that became effective as of that date, as a result of which we now hold exclusive global rights for tafasitamab, a humanized Fc-modified CD19-targeting immunotherapy marketed in the United States as MONJUVI (tafasitamab-cxix) and outside of the United States as MINJUVI (tafasitamab). Prior to the acquisition, pursuant to a now-terminated collaboration and license agreement, we and MorphoSys agreed to co-develop tafasitamab and to share development costs associated with global and U.S.-specific clinical trials, with Incyte responsible for 55% of such costs and MorphoSys responsible for 45% of such costs. Each company was responsible for funding any independent development activities, and we were responsible for funding development activities specific to territories outside of the United States.
During May 2024, as part of the Novartis tender offer for MorphoSys AG’s outstanding shares, we sold all of our 3.6 million American Depository Shares, each representing 0.25 of an ordinary share of MorphoSys AG, for proceeds of $66.6 million. The fair market value of our equity investment in MorphoSys AG as of December 31, 2023 was $35.9 million. For the nine months ended September 30, 2024, we recorded a realized gain of $30.7 million, based on the sale of shares and change in fair value of MorphoSys AG’s ordinary shares during the period. For the three and nine months ended September 30, 2023, we recorded an unrealized loss of $2.7 million and an unrealized gain of $11.4 million, respectively, based on the change in fair value of MorphoSys AG’s ordinary shares during the respective periods.
Our 50% share of the United States loss or profit for the commercialization of tafasitamab for the period from January 1, 2024 to the asset acquisition on February 5, 2024, was a profit of $1.0 million, and is recorded as (Profit) and loss sharing under collaboration agreements on the condensed consolidated statement of operations. As described in Note 6, subsequent to the asset acquisition, we recognize revenue and costs for all commercialization and clinical development of tafasitamab in the United States. Our 50% share of the United States profit or loss for the commercialization of tafasitamab for the three and nine months ended September 30, 2023 was a profit of $1.1 million and $0.9 million, respectively, and is recorded as (profit) and loss sharing under collaboration agreements on the condensed consolidated statement of operations. Research and development expenses for the period from January 1, 2024 to the asset acquisition on February 5, 2024, includes $10.7 million, related to our 55% share of the co-development costs for tafasitamab. Research and development expenses for the three and nine months ended September 30, 2023, includes $13.0 million and $58.5 million, respectively, related to our 55% share of the co-development costs for tafasitamab. At September 30, 2024 and December 31, 2023, $0.0 million and $18.8 million, respectively, was included in accrued and other liabilities on the condensed consolidated balance sheets for amounts due to MorphoSys under the former agreement.
Syndax
In September 2021, we entered into a Collaboration and License Agreement with Syndax Pharmaceuticals, Inc. (“Syndax”), covering the worldwide development and commercialization of SNDX-6352 (“axatilimab”). We and Syndax have agreed to co-develop axatilimab and to share development costs associated with global and U.S.-specific clinical trials, with Incyte responsible for 55% of such costs and Syndax responsible for 45% of such costs. Each company is responsible for funding any independent development activities.
In August 2024, we made a $12.5 million regulatory milestone payment to Syndax for the FDA approval of NIKTIMVO for the treatment of GVHD. This milestone payment was capitalized as an intangible asset and included in other intangible assets, net on the condensed consolidated balance sheet as of September 30, 2024, and is being amortized through cost of product revenues over the estimated useful life of 10 years.
Inclusive of an upfront, non-refundable payment, since the inception of the agreement through September 30, 2024, we have made payments of $129.5 million to Syndax, which were previously recorded in research and development expense or in other intangible assets, as discussed above. Syndax is eligible to receive up to $207.5 million in future contingent development and regulatory milestones and up to $230.0 million in sales milestones as well as tiered royalties ranging in the mid-teens on net sales in Europe and Japan and low double digit percentage on net sales in the rest of the world outside of the United States.
As of September 30, 2024, we held an investment of approximately 1.4 million shares of Syndax common stock. The fair market value of our long term investment in Syndax as of September 30, 2024 and December 31, 2023 was $27.4 million and $30.7 million, respectively. For the three and nine months ended September 30, 2024, we recorded an unrealized loss of $1.9 million and $3.4 million, respectively, based on the change in fair value of Syndax’s common stock during the respective periods. For the three and nine months ended September 30, 2023, we recorded an unrealized loss of $9.2 million and $15.6 million, respectively, based on the change in fair value of Syndax’s common stock during the respective periods.
Research and development expenses for the three and nine months ended September 30, 2024, includes $5.8 million and $17.6 million, respectively, related to our 55% share of the co-development costs for axatilimab. Research and development expenses for the three and nine months ended September 30, 2023, includes $5.1 million and $16.9 million, respectively, related to our 55% share of the co-development costs for axatilimab. At September 30, 2024 and December 31, 2023, $1.8 million and $1.8 million, respectively, was included in accrued and other liabilities on the condensed consolidated balance sheet for amounts due to Syndax under the agreement.
China Medical Systems Holdings Limited
In March 2024, we entered into a Collaboration and License Agreement with China Medical System Skinhealth, a wholly-owned dermatology medical aesthetic company and subsidiary of China Medical System Holdings Limited (“CMSHL”), for the development and commercialization of povorcitinib, a selective oral JAK1 inhibitor, in certain indications in certain Asian territories. In March 2024, we recognized an upfront payment under this agreement of $25.0 million upon our transfer of the functional intellectual property related to povorcitinib to CMSHL which was recorded in milestone and contract revenues on the condensed consolidated statement of operations during the first quarter of 2024. We are eligible to receive additional potential development and commercial milestones, as well as royalties on net sales of the licensed product in CMSHL’s territory. CMSHL received an exclusive license to develop and commercialize and a non-exclusive license to manufacture povorcitinib in autoimmune and inflammatory dermatologic diseases, including non-segmental vitiligo, hidradenitis suppurativa, prurigo nodularis, asthma and chronic spontaneous urticaria, for patients in mainland China, Hong Kong, Macau, Taiwan and certain countries in Southeast Asia.
Other Agreements
In addition to the license and collaboration agreements discussed above, we have various other license and collaboration agreements that are not individually material to our operating results or financial condition at this time. Pursuant to the terms of those agreements, we may be required to pay, or we may receive, additional amounts contingent upon the occurrence of various future events such as future discovery, development, regulatory or commercial milestones, which in the aggregate could be material. In addition, if any products related to these collaborations are approved for sale, we may be required to pay, or we may receive, royalties on future sales. The payment or receipt of these amounts, however, is contingent upon the occurrence of various future events, the likelihood of which cannot presently be determined.
Note 9. Property and Equipment, net
Property and equipment, net consists of the following (in thousands):
| | | | | | | | | | | |
| September 30, 2024 | | December 31, 2023 |
Office equipment | $ | 23,838 | | | $ | 23,417 | |
Laboratory equipment | 232,444 | | | 220,677 | |
Computer equipment | 154,338 | | | 147,570 | |
Land | 15,773 | | | 10,931 | |
Building and leasehold improvements | 585,320 | | | 584,755 | |
Operating lease right-of-use assets | 17,250 | | | 20,553 | |
Construction in progress | 59,950 | | | 13,544 | |
| 1,088,913 | | | 1,021,447 | |
Less accumulated depreciation and amortization | (315,811) | | | (269,934) | |
Property and equipment, net | $ | 773,102 | | | $ | 751,513 | |
In May 2024, we purchased additional property in Wilmington, Delaware including land, office buildings and parking garages for a purchase price of $48.7 million. During the nine months ended September 30, 2024, we capitalized $4.9 million of land and recorded approximately $47.2 million of construction in progress relating to the office buildings and parking garages.
Note 10. Accrued and Other Current Liabilities
Accrued and other current liabilities consisted of the following (in thousands):
| | | | | | | | | | | |
| September 30, 2024 | | December 31, 2023 |
Royalties | $ | 491,054 | | $ | 387,362 |
Clinical related costs | 120,560 | | 109,618 |
Sales allowances | 381,695 | | 279,914 |
Sales and marketing | 40,601 | | 37,369 |
Accrued taxes | 33,150 | | 42,295 |
Operating lease liabilities | 4,352 | | 5,686 |
Other current liabilities | 56,539 | | 73,325 |
Total accrued and other current liabilities | $ | 1,127,951 | | $ | 935,569 |
Note 11. Stockholders' Equity
2010 Stock Incentive Plan. In May 2010 the Board of Directors adopted the 2010 Stock Incentive Plan (the “2010 Stock Plan”), which was most recently amended in April 2023, for issuance of common stock to employees, non-employee directors, consultants, and scientific advisors. Awards under the 2010 Stock Plan include stock options, restricted stock units (“RSUs”) and performance shares (“PSUs”).
2024 Inducement Stock Incentive Plan. In January 2024, our Board of Directors adopted the Incyte Corporation 2024 Inducement Stock Incentive Plan (the “2024 Inducement Plan”). In reliance on Nasdaq Marketplace Rule 5635(c)(4), stockholder approval was not obtained. A total of 1,000,000 shares of common stock are reserved for issuance pursuant to the 2024 Inducement Plan.
Share Repurchase and Modified "Dutch Auction" Tender Offer. On May 13, 2024 we announced that our Board of Directors approved a share repurchase authorization of $2.0 billion. Subsequently, we commenced a modified “Dutch Auction” tender offer to repurchase shares of our common stock for an aggregate purchase price of up to $1.672 billion (the “tender offer”). We offered to purchase up to $1.672 billion in value of our common stock at a price not greater than $60.00 per share nor less than $52.00 per share, net to the seller in cash, less any applicable withholding taxes and without interest, upon the terms and subject to the conditions set forth in the tender offer documents that were distributed to stockholders. A modified “Dutch Auction” tender offer allows stockholders to indicate how much stock they wish to tender and at what price within the range described above. Based on the number of shares tendered and the prices specified by the tendering stockholders, we determined the lowest price per share that enabled us to purchase $1.672 billion of common stock at such price. On June 13, 2024 we completed the tender offer and repurchased 27,866,666 shares at a price of $60.00 per share for an aggregate price of approximately $1.672 billion, excluding fees and related expenses, pursuant to the tender offer.
In addition, on May 12, 2024, we entered into a separate stock purchase agreement with Julian C. Baker (a member of our Board of Directors), Felix J. Baker, and entities affiliated with Julian C. and Felix J. Baker, including funds advised by Baker Bros. Advisors LP (collectively, the “Baker Entities”), to repurchase up to $328.0 million of our common stock. This would enable the Baker Entities to maintain their ownership level as of May 9, 2024 of approximately 16.4% of Incyte’s outstanding common stock. The Baker Entities purchase was to be at the same price per share as is determined and paid in the tender offer. On June 26, 2024, we repurchased 5,459,183 shares at a price of $60.00 per share for an aggregate price of approximately $328.0 million pursuant to the terms of the stock purchase agreement with the Baker Entities.
We account for share repurchases as retirements, whereby it reduces common stock and additional paid-in capital by the amount of the original issuance, with any excess purchase price recorded as a reduction to retained earnings (accumulated deficit). Any transaction costs, including the excise tax, directly associated with the share repurchases are included as part of the purchase price. Under this method, the issued and outstanding shares of common stock are reduced by the number of shares of common stock repurchased, and no treasury stock is recognized on the condensed consolidated financial statements.
A total of 33,325,849 common shares were repurchased during June 2024 at a price of $60.00 per share for an aggregate purchase price of approximately $2.0 billion. We incurred $24.4 million in fees and expenses associated with the share repurchase, which included $19.2 million for excise taxes on share repurchases in accordance with the Inflation Reduction Act of 2022. We currently expect to pay the excise tax in the first half of 2025. These costs are recognized within (accumulated deficit) retained earnings on the condensed consolidated balance sheet as of September 30, 2024 as costs to repurchase our common stock. The purchased shares were cancelled and ceased to be outstanding.
Note 12. Stock Compensation
We recorded $77.9 million and $194.3 million of stock compensation expense on our condensed consolidated statements of operations for the three and nine months ended September 30, 2024, respectively. We recorded $48.0 million and $155.9 million of stock compensation expense on our condensed consolidated statements of operations for the three and nine months ended September 30, 2023, respectively. Stock compensation expense included within our condensed consolidated statements of operations included research and development expense of $45.8 million, $117.1 million, $26.9 million and $90.7 million for the three and nine months ended September 30, 2024 and 2023, respectively. Stock compensation expense included within our condensed consolidated statements of operations also included selling, general and administrative expense of $31.5 million, $75.6 million, $20.3 million and $62.8 million for the three and nine months ended September 30, 2024 and 2023, respectively. Stock compensation expense included within our condensed consolidated statements of operations also included cost of product revenues of $0.6 million, $1.6 million, $0.8 million and $2.4 million, respectively, for the three and nine months ended September 30, 2024 and 2023.
Additionally, as described in Note 6, as part of the Escient acquisition, during the nine months ended September 30, 2024, we recognized related compensation expense of approximately $31.5 million associated with the accelerated vesting for certain Escient stock awards in connection with the acquisition on our condensed consolidated statements of operations.
We utilized the Black-Scholes valuation model for estimating the fair value of the stock compensation granted, with the following weighted-average assumptions:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Employee Stock Options | | Employee Stock Purchase Plan |
| For the Three Months Ended | | For the Nine Months Ended | | For the Three Months Ended | | For the Nine Months Ended |
| September 30, | | September 30, |
| 2024 | | 2023 | | 2024 | | 2023 | | 2024 | | 2023 | | 2024 | | 2023 |
Average risk-free interest rates | 4.18 | % | | 4.17 | % | | 4.15 | % | | 3.95 | % | | 4.38 | % | | 5.03 | % | | 4.96 | % | | 4.50 | % |
Average expected life (in years) | 5.17 | | 5.16 | | 5.02 | | 5.05 | | 0.50 | | 0.50 | | 0.50 | | 0.50 |
Volatility | 29 | % | | 32 | % | | 30 | % | | 32 | % | | 28 | % | | 24 | % | | 24 | % | | 22 | % |
Weighted-average fair value (in dollars) | $ | 21.54 | | | $ | 22.32 | | | $ | 21.02 | | | $ | 24.68 | | | $ | 12.11 | | | $ | 15.36 | | | $ | 11.27 | | | $ | 14.72 | |
The risk-free interest rate is derived from the U.S. Federal Reserve rate in effect at the time of grant. The expected life calculation is based on the observed and expected time to the exercise of options by our employees based on historical exercise patterns for similar type options. Expected volatility is based on the historical volatility of our common stock over the period commensurate with the expected life of the options. A dividend yield of zero is assumed based on the fact that we have never paid cash dividends and have no present intention to pay cash dividends. Nonemployee awards are measured on the grant date by estimating the fair value of the equity instruments to be issued using the expected term, similar to our employee awards.
Option activity under our 2010 Stock Plan and 2024 Inducement Plan was as follows:
| | | | | | | | | | | |
| Shares Subject to Outstanding Options |
| Shares | | Weighted Average Exercise Price |
Balance at December 31, 2023 | 12,457,158 | | $ | 85.40 | |
Options granted | 1,320,585 | | $ | 62.42 | |
Options exercised | (58,614) | | $ | 57.75 | |
Options cancelled | (472,808) | | $ | 87.31 | |
Balance at September 30, 2024 | 13,246,321 | | $ | 83.16 | |
Our annual stock option grants generally have a 10-year term and vest over four years, with 25% vesting after one year and the remainder vesting in 36 equal monthly installments, subject to customary retirement provisions that may accelerate the requisite service period for expense recognition purposes.
RSU and PSU award activity under the 2010 Stock Plan and 2024 Inducement Plan was as follows:
| | | | | | | | | | | |
| Shares Subject to Outstanding Awards |
| Shares | | Grant Date Value |
Balance at December 31, 2023 | 7,165,342 | | $ | 72.17 | |
RSUs granted | 3,392,462 | | $ | 63.77 | |
PSUs granted | 321,582 | | $ | 65.40 | |
Additional PSUs earned | 21,866 | | $ | 83.58 | |
RSUs released | (1,859,539) | | $ | 75.70 | |
PSUs released | (105,453) | | $ | 83.58 | |
RSUs cancelled | (244,641) | | $ | 69.91 | |
PSUs cancelled | (7,795) | | $ | 83.58 | |
Balance at September 30, 2024 | 8,683,824 | | $ | 67.79 | |
RSUs and PSUs are granted to our employees at the share price on the date of grant. Each RSU represents the right to acquire one share of our common stock. Each RSU granted in connection with our annual equity awards will vest 25% annually over four years, while each RSU granted as outstanding merit awards or as part of retention award programs will vest in a single installment at the end of four years, subject to customary retirement provisions that may accelerate the requisite service period for expense recognition purposes.
We grant PSUs with performance and/or service-based milestones with graded and/or cliff vesting over three to four years. The shares of our common stock into which each PSU may convert is subject to a multiplier based on the level at which the financial, developmental and market performance conditions are achieved over the service period. Compensation expense for PSUs with financial and developmental performance conditions is recorded over the estimated service period for each milestone when the performance conditions are deemed probable of achievement. For PSUs containing performance conditions which were not deemed probable of achievement, no stock compensation expense is recorded. Compensation expense for PSUs with market performance conditions is calculated using a Monte Carlo simulation model as of the date of grant and recorded over the requisite service period. For the three and nine months ended September 30, 2024 we recorded $12.3 million and $19.2 million, respectively, of stock compensation expense for PSUs on our condensed consolidated statements of operations. For the three and nine months ended September 30, 2023 we recorded $4.2 million and $13.4 million, respectively, of stock compensation expense for PSUs on our condensed consolidated statements of operations.
The following table summarizes our shares available for grant under the 2010 Stock Plan and 2024 Inducement Plan. Each RSU and PSU grant reduces the available share pool by 2 shares.
| | | | | |
| Shares Available for Grant |
Balance at December 31, 2023 | 10,815,026 |
Additional authorization - 2024 Inducement Plan | 1,000,000 |
Options, RSUs and PSUs granted | (8,792,405) |
Options, RSUs and PSUs cancelled | 977,680 |
Balance at September 30, 2024 | 4,000,301 |
Based on our historical experience of employee turnover, we have assumed an annualized forfeiture rate of 5% for our options, RSUs and PSUs. Under the true-up provisions of the stock compensation guidance, we will record additional expense if the actual forfeiture rate is lower than we estimated, and will record a recovery of prior expense if the actual forfeiture is higher than we estimated.
Total compensation cost of options granted but not yet vested, as of September 30, 2024, was $26.2 million, which is expected to be recognized over the weighted average period of approximately 1.1 years. Total compensation cost of RSUs granted but not yet vested, as of September 30, 2024, was $280.1 million, which is expected to be recognized over the weighted average period of approximately 1.8 years. Total compensation cost of PSUs granted but not yet vested, as of September 30, 2024, was $25.4 million, which is expected to be recognized over the weighted average period of 1.2 years, should the underlying performance conditions be deemed probable of achievement.
Note 13. Income Taxes
For the three and nine months ended September 30, 2024 and 2023, we recorded the following provisions for income taxes and effective tax rates as compared to our income before provision for income taxes (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
(Loss) income before provision for income taxes | $ | 156,524 | | | $ | 233,799 | | | $ | 2,906 | | | $ | 563,259 | |
Provision for income taxes | 50,068 | | | 62,530 | | | 171,503 | | | 166,739 | |
| | | | | | | |
Effective tax rate | 32.0% | | 26.7% | | 5901.7% | | 29.6% |
Our effective tax rate for the three months ended September 30, 2024 was higher than the U.S. statutory rate primarily due to foreign losses with no associated tax benefit (i.e., full valuation allowance) and an increase in our valuation allowance against certain U.S. federal and state deferred tax assets. This was partially offset by tax rate benefits associated with research and development and orphan drug tax credit generations and the foreign derived intangible income deduction. Our effective tax rate for the nine months ended September 30, 2024 was higher than the U.S. statutory rate primarily due to non-deductible charges of $710.9 million associated with the Escient acquisition. Our effective tax rate for the three and nine months ended September 30, 2023 was higher than the U.S. statutory rate primarily due to foreign losses with no associated tax benefit and an increase in our valuation allowance against certain U.S. federal and state deferred tax assets. This was partially offset by tax rate benefits associated with research and development and orphan drug tax credit generations and the foreign derived intangible income deduction.
The effective tax rate for the three months ended September 30, 2024 was unfavorable as compared to the prior year period primarily due to an increase in our valuation allowance against certain U.S. federal and state deferred tax assets, partially offset by a decrease in foreign losses with no associated tax benefit. The effective tax rate for the nine months ended September 30, 2024 was unfavorable as compared to the prior year period primarily due to the non-deductible charges associated with the Escient acquisition.
As described in Note 6, as part of the Escient acquisition, we recorded $44.8 million of deferred tax assets predominately related to net operating losses and capitalized researched and development costs.
The balance of our unrecognized tax benefits (including penalties and interest) increased by $22.5 million during the nine months ended September 30, 2024. This movement was primarily driven by net increases related to prior period tax positions of $6.1 million, increases related to current period tax positions of $2.8 million, increases related to acquired reserves of $9.1 million, and $4.7 million of interest and penalties. We accrue interest and penalties related to unrecognized tax benefits as a component of the provision for income taxes. We do not expect any significant decreases in unrecognized tax benefits within the next 12 months.
One or more of our legal entities file income tax returns in the U.S. and in certain foreign jurisdictions. Our income tax returns may be examined by tax authorities in those jurisdictions. Significant disputes may arise with tax authorities involving issues such as the timing and amount of deductions, the use of tax credits and allocations of income and expenses among various tax jurisdictions because of differing interpretations of tax laws and regulations and relevant facts. In the U.S., the statute of limitations remains open beginning with tax year 2020. We are currently under U.S. federal audit for tax year 2021.
The Organization for Economic Cooperation and Development Pillar 2 guidelines, which were supported by over 130 countries worldwide, are designed to impose a 15% global minimum tax on adjusted financial results. Certain aspects of Pillar 2 took effect on January 1, 2024, while other aspects go into effect on January 1, 2025. We are evaluating the potential impact of Pillar 2 on our business, as many of the countries in which we operate are enacting legislation implementing Pillar 2. Although many aspects of Pillar 2 remain to be clarified, at this time there are no material impacts on our effective tax rate.
Note 14. Net Income (Loss) Per Share
Net income (loss) per share was calculated as follows for the periods indicated below:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Basic net income (loss) | $ | 106,456 | | | $ | 171,269 | | | $ | (168,597) | | | $ | 396,520 | |
| | | | | | | |
Weighted average common shares outstanding | 192,629 | | 224,078 | | 211,763 | | 223,428 |
| | | | | | | |
Basic net income (loss) per share | $ | 0.55 | | | $ | 0.76 | | | $ | (0.80) | | | $ | 1.77 | |
| | | | | | | |
Diluted net income (loss) | $ | 106,456 | | | $ | 171,269 | | | $ | (168,597) | | | $ | 396,520 | |
| | | | | | | |
Weighted average common shares outstanding | 192,629 | | 224,078 | | 211,763 | | 223,428 |
Dilutive stock options and awards | 3,209 | | | 2,089 | | — | | | 2,328 |
Weighted average shares used to compute diluted net income (loss) per share | 195,838 | | 226,167 | | 211,763 | | 225,756 |
| | | | | | | |
Diluted net income (loss) per share | $ | 0.54 | | | $ | 0.76 | | | $ | (0.80) | | | $ | 1.76 | |
All stock options and stock awards were excluded from the diluted share calculation for the nine months ended September 30, 2024 because their effect would have been anti-dilutive, as we were in a net loss position. The potential common shares that were excluded from the diluted net income (loss) per share computation are as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Outstanding stock options and awards | 13,067,516 | | 12,997,146 | | 16,881,330 | | 11,964,901 |
Note 15. Employee Benefit Plans
Defined Contribution Plans
We have a defined contribution plan qualified under Section 401(k) of the Internal Revenue Code covering all U.S. employees and defined contribution plans for other Incyte employees in Europe and Japan. Employees may contribute a portion of their compensation, which is then matched by us, subject to certain limitations. Defined contribution expense for the three and nine months ended September 30, 2024 was $5.2 million and $15.8 million, respectively. Defined contribution expense for the three and nine months ended September 30, 2023 was $5.0 million and $14.6 million, respectively.
Defined Benefit Pension Plans
We have defined benefit pension plans for our employees in Europe which provide benefits to employees upon retirement, death or disability. The assets of the pension plans are held in collective investment accounts represented by the cash surrender value of an insurance policy and are classified as Level 2 within the fair value hierarchy.
The net periodic benefit cost was as follows (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Service cost | $ | 2,537 | | | $ | 1,999 | | | $ | 7,815 | | | $ | 5,820 | |
Interest cost | 750 | | | 1,060 | | | 1,977 | | | 1,721 | |
Expected return on plan assets | (1,871) | | | (2,017) | | | (5,315) | | | (4,293) | |
Amortization of prior service cost | 217 | | | 175 | | | 624 | | | 554 | |
Amortization of actuarial losses | 167 | | | — | | | 647 | | | — | |
Net periodic benefit cost | $ | 1,800 | | | $ | 1,217 | | | $ | 5,748 | | | $ | 3,802 | |
The components of net periodic benefit cost other than the service cost component are included in Interest income and other, net on the condensed consolidated statements of operations. We expect to contribute a total of $10.0 million to the pension plans in 2024 inclusive of the amounts contributed to the plan during the current period.
Note 16. Commitments and Contingencies
Commitments
In August 2021, we entered into a revolving credit and guaranty agreement, which was subsequently amended in May 2023 and June 2024 (as amended, the “Credit Agreement”), among Incyte Corporation, as borrower, our subsidiary Incyte Holdings Corporation, as a guarantor, a group of lenders (the “Lenders”), and J.P. Morgan Chase Bank, N.A., as administrative agent. Under the Credit Agreement, the Lenders have committed to provide an unsecured revolving credit facility in an aggregate principal amount of up to $500.0 million. The June 2024 amendment to the Credit Agreement extended the maturity date of the revolving credit facility from August 2024 to June 2027. We may increase the maximum revolving commitments or add one or more incremental term loan facilities to the Credit Agreement, subject to obtaining commitments from any participating lenders and certain other conditions, in an amount not to exceed (1) $250.0 million plus (2) an additional amount, so long as after giving effect to the incurrence of such additional amount, our pro forma consolidated leverage ratio would not exceed 0.25:1.00 above our consolidated leverage ratio in effect immediately prior to giving effect to such increase.