FULLTEXT DEL 1 AV 2
10-Q – 2025-10-28 – incy-20250930.htm
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Table of Contents
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, 2025
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 196,322,703 as of October 21, 2025.
Table of Contents
INCYTE CORPORATION
INDEX
PART I: FINANCIAL INFORMATION
3
Item 1.
Financial Statements
3
Condensed Consolidated Balance Sheets
3
Condensed Consolidated Statements of Operations
4
Condensed Consolidated Statements of Comprehensive Income (Loss)
5
Condensed Consolidated Statements of Stockholders’ Equity
6
Condensed Consolidated Statements of Cash Flows
8
Notes to Condensed Consolidated Financial Statements
9
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
32
Forward-Looking Statements
32
Summary Risk Factors
35
Item 3.
Quantitative and Qualitative Disclosures about Market Risk
53
Item 4.
Controls and Procedures
54
PART II: OTHER INFORMATION
Item 1 .
Legal Proceedings
54
Item 1A.
Risk Factors
54
Item 5.
Other Information
82
Item 6.
Exhibits
84
Signatures
85
2
Table of Contents
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,
2025 December 31,
2024*
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 2,455,006 $ 1,687,829
Marketable securities—available-for-sale (amortized cost $ 473,126 and $ 469,917 as of September 30, 2025 and December 31, 2024, respectively; allowance for credit losses $ 0 as of September 30, 2025 and December 31, 2024)
474,814 470,263
Accounts receivable 895,890 853,154
Inventory 83,447 58,872
Prepaid expenses and other current assets 368,732 168,912
Total current assets 4,277,889 3,239,030
Restricted cash 1,843 1,622
Long term equity investments 21,870 18,814
Inventory 366,510 348,327
Property and equipment, net 798,634 763,411
Finance lease right-of-use assets, net 28,155 30,803
Other intangible assets, net 119,421 113,803
Goodwill 155,593 155,593
Deferred income tax asset 528,138 762,071
Other assets, net 32,303 10,848
Total assets $ 6,330,356 $ 5,444,322
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 171,925 $ 197,465
Accrued compensation 168,250 188,677
Accrued and other current liabilities 948,439 1,212,048
Finance lease liabilities 4,491 4,419
Acquisition-related contingent consideration 45,624 39,238
Total current liabilities 1,338,729 1,641,847
Acquisition-related contingent consideration 138,376 153,762
Finance lease liabilities 30,881 33,542
Other liabilities 171,176 167,543
Total liabilities 1,679,162 1,996,694
Commitments and contingencies (Note 17)
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; 196,130,993 and 193,434,305 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively
196 193
Additional paid-in capital 4,721,953 4,533,437
Accumulated other comprehensive income (loss) 14,555 ( 13,121 )
Accumulated deficit ( 85,510 ) ( 1,072,881 )
Total stockholders’ equity 4,651,194 3,447,628
Total liabilities and stockholders’ equity $ 6,330,356 $ 5,444,322
* The condensed consolidated balance sheet at December 31, 2024 has been derived from the audited consolidated financial statements at that date.
See accompanying notes.
3
Table of Contents
INCYTE CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share amounts)
Three Months Ended
September 30, Nine Months Ended
September 30,
2025 2024 2025 2024
Revenues:
Product revenues, net $ 1,149,856 $ 962,992 $ 3,131,544 $ 2,599,481
Product royalty revenues 171,124 156,879 452,863 420,038
Milestone and contract revenues 45,000 18,000 50,000 43,000
Total revenues 1,365,980 1,137,871 3,634,407 3,062,519
Costs, expenses and other:
Cost of product revenues (including definite-lived intangible amortization) 99,001 85,993 250,955 223,583
Contract dispute settlement — — ( 242,251 ) —
Research and development 506,584 573,174 1,438,780 2,140,814
Selling, general and administrative 329,081 309,209 985,794 915,447
(Gain) loss on change in fair value of acquisition-related contingent consideration ( 12,204 ) 23,410 22,129 23,847
(Profit) and loss sharing under collaboration agreements — — — ( 1,025 )
Total costs, expenses and other 922,462 991,786 2,455,407 3,302,666
Income (loss) from operations 443,518 146,085 1,179,000 ( 240,147 )
Interest income 26,781 19,266 74,846 107,512
Interest expense ( 592 ) ( 774 ) ( 1,846 ) ( 1,861 )
Gain (loss) on equity investments 8,558 ( 12,982 ) 3,064 126,206
Other, net 4,043 4,929 19,446 11,196
Income before provision for income taxes 482,308 156,524 1,274,510 2,906
Provision for income taxes 58,139 50,068 287,139 171,503
Net income (loss) $ 424,169 $ 106,456 $ 987,371 $ ( 168,597 )
Net income (loss) per share:
Basic $ 2.17 $ 0.55 $ 5.08 $ ( 0.80 )
Diluted $ 2.11 $ 0.54 $ 4.95 $ ( 0.80 )
Shares used in computing net income (loss) per share:
Basic 195,670 192,629 194,459 211,763
Diluted 201,429 195,838 199,405 211,763
See accompanying notes.
4
Table of Contents
INCYTE CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(unaudited, in thousands)
Three Months Ended
September 30, Nine Months Ended
September 30,
2025 2024 2025 2024
Net income (loss) $ 424,169 $ 106,456 $ 987,371 $ ( 168,597 )
Other comprehensive income (loss):
Foreign currency translation gain (loss) 156 15,228 24,661 ( 2,185 )
Unrealized gain on marketable securities, net of tax 375 5,463 1,342 3,463
Defined benefit pension gain, net of tax 585 384 1,673 1,271
Other comprehensive income (loss) 1,116 21,075 27,676 2,549
Comprehensive income (loss) $ 425,285 $ 127,531 $ 1,015,047 $ ( 166,048 )
See accompanying notes.
5
Table of Contents
INCYTE CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(unaudited, in thousands, except number of shares)
Common
Stock Additional
Paid-in Capital Accumulated Other
Comprehensive (Loss) Income Accumulated Deficit Total
Stockholders’
Equity
Balances at January 1, 2025 $ 193 $ 4,533,437 $ ( 13,121 ) $ ( 1,072,881 ) $ 3,447,628
Issuance of 363,987 shares of Common Stock upon exercise of stock options and settlement of employee restricted stock units, net of shares withheld for taxes
— ( 6,215 ) — — ( 6,215 )
Issuance of 1,208 shares of Common Stock for services rendered
— 82 — — 82
Stock compensation — 60,982 — — 60,982
Other comprehensive income — — 6,883 — 6,883
Net income — — — 158,203 158,203
Balances at March 31, 2025 $ 193 $ 4,588,286 $ ( 6,238 ) $ ( 914,678 ) $ 3,667,563
Issuance of 64,400 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 261,762 shares of Common Stock under the ESPP
1 13,972 — — 13,973
Issuance of 1,220 shares of Common Stock for services rendered
— 82 — — 82
Stock compensation — 64,609 — — 64,609
Other comprehensive income — — 19,677 — 19,677
Net income — — — 404,999 404,999
Balances at June 30, 2025 $ 194 $ 4,666,949 $ 13,439 $ ( 509,679 ) $ 4,170,903
Issuance of 2,011,476 shares of Common Stock upon exercise of stock options and settlement of employee restricted stock units, net of shares withheld for taxes
2 ( 6,676 ) — — ( 6,674 )
Issuance of 962 shares of Common Stock for services rendered
— 82 — — 82
Stock compensation — 61,598 — — 61,598
Other comprehensive income — — 1,116 — 1,116
Net income — — — 424,169 424,169
Balances at September 30, 2025 $ 196 $ 4,721,953 $ 14,555 $ ( 85,510 ) $ 4,651,194
6
Table of Contents
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 (Loss) 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
Balances 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
See accompanying notes.
7
Table of Contents
INCYTE CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited, in thousands)
Nine Months Ended September 30,
2025 2024
Cash flows from operating activities:
Net income (loss) $ 987,371 $ ( 168,597 )
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Depreciation and amortization 69,304 66,515
Stock-based compensation 187,189 194,340
Deferred income taxes 234,188 ( 85,609 )
Other, net 3,445 ( 4,824 )
(Gain) on equity investments ( 3,064 ) ( 126,206 )
Loss on change in fair value of acquisition-related contingent consideration 22,129 23,847
Changes in operating assets and liabilities:
Accounts receivable ( 42,275 ) ( 14,893 )
Prepaid expenses and other assets ( 221,275 ) ( 55,381 )
Inventory ( 53,654 ) ( 93,352 )
Accounts payable ( 26,414 ) 69,109
Accrued and other liabilities ( 286,747 ) 149,170
Net cash provided by (used in) operating activities 870,197 ( 45,881 )
Cash flows from investing activities:
Sale of equity investments 8 282,866
Capital expenditures ( 36,990 ) ( 68,879 )
Payments for intangible assets ( 25,000 ) ( 13,900 )
Purchases of marketable securities ( 212,852 ) ( 228,986 )
Maturities of marketable securities 209,643 207,881
Net cash (used in) provided by investing activities ( 65,191 ) 178,982
Cash flows from financing activities:
Repurchases of Common Stock — ( 2,004,790 )
Excise tax paid on repurchase of Common Stock ( 19,100 ) —
Proceeds from issuance of Common Stock under stock plans 61,553 16,242
Tax withholdings related to restricted and performance share vesting ( 60,469 ) ( 39,416 )
Payment of finance lease liabilities ( 3,386 ) ( 2,761 )
Payment of contingent consideration ( 15,298 ) ( 11,216 )
Net cash used in financing activities ( 36,700 ) ( 2,041,941 )
Effect of exchange rates on cash, cash equivalents, and restricted cash ( 908 ) ( 535 )
Net increase (decrease) in cash, cash equivalents, and restricted cash 767,398 ( 1,909,375 )
Cash, cash equivalents, and restricted cash at beginning of period 1,689,451 3,215,221
Cash, cash equivalents, and restricted cash at end of period $ 2,456,849 $ 1,305,846
Supplemental Schedule of Cash Flow Information
Income taxes paid $ 185,221 $ 302,860
Cash paid for contract dispute settlement $ 294,881 $ —
Unpaid excise tax on repurchase of Common Stock $ — $ 19,185
Unpaid purchases of property and equipment $ 4,158 $ 3,538
Leased assets obtained in exchange for new operating lease liabilities $ 3,163 $ 2,436
Leased assets obtained in exchange for new finance lease liabilities $ 438 $ 1,959
See accompanying notes.
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INCYTE CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2025
(Unaudited)
Note 1. Organization and Business
Incyte Corporation (including its subsidiaries, “Incyte,” “we,” “us,” or “our”) is a global biopharmaceutical company engaged in the discovery, development and commercialization of 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 is 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 (“U.S. GAAP”) 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, 2025, the condensed consolidated statements of operations, comprehensive income (loss), and stockholders’ equity for the three and nine months ended September 30, 2025 and 2024, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2025 and 2024, 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, 2024 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 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, 2024.
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 U.S. GAAP 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 December 2023, the Financial Accounting Standards Board (“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, and are applicable for disclosures in our Annual Report on Form 10-K beginning with the year ending December 31, 2025. We are currently evaluating the impact that ASU No. 2023-09 will have on our income tax disclosures and the method of adoption. ASU No. 2023-09 does not affect our results of operations, financial condition or cash flows.
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In November 2024, the FASB issued ASU No. 2024-03, “ Disaggregation of Income Statement Expenses (DISE).” This new guidance applies to all public entities and requires disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. Public entities must adopt the new standard prospectively for fiscal years beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption and retrospective application are permitted. We are currently evaluating the impact ASU No. 2024-03 will have on our consolidated financial statements and related disclosures.
In July 2025, the FASB issued ASU No. 2025-05, “ Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets. ” This amended guidance applies to all entities and aims to simplify the estimation of expected credit losses for current accounts receivable and contract assets by providing a practical expedient for all companies. The amendments are effective for annual reporting periods beginning after December 15, 2025 and interim reporting periods within those annual periods. If electing the practical expedient, entities should apply the amendments in this update prospectively. We are currently evaluating the impact ASU No. 2025-05 will have on our consolidated financial statements and related disclosures.
In September 2025, the FASB issued ASU No. 2025-06, “ Intangibles - Goodwill and Other - Internal-Use (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software. ” This amended guidance applies to all entities and serves to modernize the accounting for software costs that are accounted for under Subtopic 305-40, Intangibles - Goodwill and Other - Internal-Use Software (referred to as “internal-use software”). The amendments in this update are effective for all entities for annual reporting periods beginning after December 15, 2027, and interim reporting periods within those annual reporting periods. Early adoption is permitted as of the beginning of an annual reporting period. Entities may adopt the new guidance using a prospective, modified, or retrospective transition approach. We are currently evaluating the impact ASU No. 2025-06 will have on our consolidated financial statements and related disclosures.
In September 2025, the FASB issued ASU No. 2025-07, “ Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606): Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract. ” This amended guidance applies to all entities and it refines the scope of derivative accounting and clarifies rules for share-based noncash consideration in revenue contracts. Specifically, this update is intended to address concerns about the application of derivative accounting to contracts that have features based on the operations or activities of one of the parties to the contract and to reduce diversity in the accounting for share-based payments in revenue contracts. The amendments in this update are effective for all entities for annual reporting periods beginning after December 15, 2026, and interim reporting periods within those annual reporting periods. Early adoption is permitted. Entities may adopt the new guidance prospectively, or on a modified retrospective basis. We are currently evaluating the impact ASU No. 2025-07 will have on our consolidated financial statements and related disclosures.
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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,
2025 2024 2025 2024
JAKAFI revenues, net $ 791,071 $ 741,181 $ 2,264,271 $ 2,018,993
OPZELURA revenues, net 187,968 139,272 471,172 346,691
ICLUSIG revenues, net 37,582 29,745 99,855 86,950
PEMAZYRE revenues, net 22,741 20,661 63,373 58,606
MINJUVI/MONJUVI revenues, net 41,990 31,439 102,672 86,429
NIKTIMVO revenues, net 45,830 — 95,597 —
ZYNYZ revenues, net 22,674 694 34,604 1,812
Total product revenues, net 1,149,856 962,992 3,131,544 2,599,481
JAKAVI product royalty revenues 125,645 115,741 327,504 304,653
OLUMIANT product royalty revenues 37,111 34,796 101,393 97,087
TABRECTA product royalty revenues 6,513 5,928 19,558 16,460
Other product royalty revenues 1,855 414 4,408 1,838
Total product royalty revenues 171,124 156,879 452,863 420,038
Milestone and contract revenues 45,000 18,000 50,000 43,000
Total revenues $ 1,365,980 $ 1,137,871 $ 3,634,407 $ 3,062,519
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 Unrealized Gains Unrealized Losses
Fair Value
September 30, 2025
Debt securities (government) $ 473,126 $ 1,804 $ ( 116 ) $ 474,814
December 31, 2024
Debt securities (government) $ 469,917 $ 971 $ ( 625 ) $ 470,263
The table below summarizes the contractual maturities of our available-for-sale debt securities as of September 30, 2025 (in thousands):
Total Less than 1 Year 1-5 Years
Fair value of debt securities (government) $ 474,814 $ 177,755 $ 297,059
Debt security assets were assessed for risk of expected credit losses. As of September 30, 2025 and December 31, 2024, 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.
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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.
At September 30, 2025 and December 31, 2024, 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 three and nine months ended September 30, 2025.
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, 2025
Cash and cash equivalents $ 2,455,006 $ — $ — $ 2,455,006
Debt securities (government) — 474,814 — 474,814
Long term equity investments (Note 8)
21,870 — — 21,870
Total assets $ 2,476,876 $ 474,814 $ — $ 2,951,690
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, 2024
Cash and cash equivalents $ 1,687,829 $ — $ — $ 1,687,829
Debt securities (government) — 470,263 — 470,263
Long term equity investments (Note 8)
18,814 — — 18,814
Total assets $ 1,706,643 $ 470,263 $ — $ 2,176,906
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The following fair value hierarchy table presents information about each major category of our financial liabilities measured at fair value on a recurring basis (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, 2025
Acquisition-related contingent consideration $ — $ — $ 184,000 $ 184,000
Total liabilities $ — $ — $ 184,000 $ 184,000
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, 2024
Acquisition-related contingent consideration $ — $ — $ 193,000 $ 193,000
Total liabilities $ — $ — $ 193,000 $ 193,000
The following is a roll forward of our Level 3 liabilities (in thousands):
2025
Balance at January 1, $ 193,000
Contingent consideration earned during the period but not yet paid ( 10,797 )
Payments made during the period ( 20,332 )
Change in fair value of contingent consideration 22,129
Balance at September 30, $ 184,000
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, 2025 and December 31, 2024 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, 2025 was due primarily to updated projections of future net revenues of ICLUSIG, including the impacts from fluctuations in foreign currency exchange rates, and the passage of time.
We generally make payments to Takeda Pharmaceutical Company Limited quarterly based on the royalties earned in the previous quarter. As of September 30, 2025 and December 31, 2024, contingent consideration earned but not yet paid was $ 10.8 million and $ 10.0 million, respectively, and was included in accrued and other current liabilities.
Note 5. Concentration of Credit Risk and Current Expected Credit Losses
In November 2009, we entered into a collaboration and license agreement with Novartis Pharma AG (formerly known as 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, 20 % and 19 % of the accounts receivable balance as of September 30, 2025 and December 31, 2024, respectively. For further information relating to these collaboration and license agreements, refer to Note 8.
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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,
2025 2024 2025 2024
Customer A 14 % 15 % 13 % 15 %
Customer B 8 % 10 % 9 % 10 %
Customer C 20 % 20 % 21 % 19 %
Customer D 15 % 13 % 15 % 13 %
Customer E 10 % 10 % 10 % 10 %
Customer F 11 % 8 % 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 the aggregate, 59 % and 54 % of the accounts receivable balance as of September 30, 2025 and December 31, 2024, 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, 2025 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, 2025 and December 31, 2024, we had no allowance for doubtful accounts.
Note 6. Acquisitions
Tafasitamab
On February 5, 2024, pursuant to a purchase agreement with MorphoSys AG and MorphoSys US Inc., a wholly-owned subsidiary of MorphoSys AG (together with MorphoSys AG, “MorphoSys”), we acquired 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 recognize revenue and costs for all U.S. commercialization and clinical development of tafasitamab and MorphoSys is no longer eligible to receive future milestone, profit split or 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.
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Under the purchase agreement, we also became 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. During the first quarter of 2025, we paid Xencor a development milestone of $ 12.5 million for the U.S. Food and Drug Administration’s (“FDA”) acceptance of the Biologics License Application filing for the use of tafasitamab for follicular lymphoma. In June 2025, we recorded a $ 25.0 million regulatory milestone owed to Xencor for the FDA approval of MONJUVI for the treatment of follicular lymphoma. 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, 2025. The intangible asset will be amortized through cost of product revenues over the estimated useful life of 8 years. Xencor is entitled to receive up to an additional $ 149.0 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 with Escient.
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 for the quarter 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
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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 amount of future product revenues, 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 statements of operations during nine months ended September 30, 2024.
Note 7. Inventory
Our inventory balance consists of the following (in thousands):
September 30,
2025 December 31,
2024
Raw materials $ 30,730 $ 27,590
API and Work-in-process 354,360 331,178
Finished goods 64,867 48,431
Total inventory $ 449,957 $ 407,199
Inventories, stated at the lower of cost and net realizable value, consist of raw materials, active pharmaceutical ingredients (“API”), work-in-process, and finished goods, inclusive of freight and inventoriable overhead. At September 30, 2025, $ 83.4 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, 2025, $ 366.5 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 condensed consolidated statements of operations. At September 30, 2025, inventory with approximately $ 45.4 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 43 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, 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.
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We were 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, 2025, 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 are obligated to pay to Novartis tiered royalties in the low single-digits on future JAKAFI net sales within the United States. On May 11, 2025, we and Novartis entered into a settlement agreement (the “Settlement Agreement”) with respect to litigation initiated by Novartis relating to the duration of royalty payments owed by us to Novartis under the Collaboration and License Agreement. As of March 31, 2025, we had approximately $ 537.1 million of accrued royalties relating to the dispute with Novartis included in accrued and other current liabilities on our condensed consolidated balance sheet. Under the Settlement Agreement, we paid Novartis $ 280.0 million as the settlement of disputed royalties on net sales of JAKAFI in the United States through December 31, 2024, and agreed to reduce by 50 % the royalty rate payable by us on future net sales of JAKAFI in the United States beginning January 1, 2025 for a period defined in the Settlement Agreement. The reduced royalty paid for the quarter ended March 31, 2025, was approximately $ 14.9 million. The difference of $ 242.2 million between the total accrued royalties and the total amount paid by us to Novartis as disclosed above was recorded in Contract dispute settlement on our condensed consolidated statement of operations for nine months ended September 30, 2025.
During the three and nine months ended September 30, 2025, such royalties on net sales within the United States totaled $ 19.3 million and $ 67.8 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, 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. At September 30, 2025 and December 31, 2024, approximately $ 19.4 million and $ 507.4 million, respectively, of accrued royalties were included in accrued and other current liabilities on the condensed consolidated balance sheets.
We also are eligible to receive tiered, double-digit royalties ranging from the upper-teens to the mid-twenties on future JAKAVI (the trade name used by Novartis for ruxolitinib sales outside of the United States) net sales outside of the United States, and tiered, worldwide royalties on TABRECTA net sales that range from 12 % to 14 %. Product royalty revenue related to Novartis’ net sales of JAKAVI outside of the United States for the three and nine months ended September 30, 2025, was $ 125.6 million and $ 327.5 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, 2024, was $ 115.7 million and $ 304.7 million, respectively. Product royalty revenue related to Novartis’ net sales of TABRECTA worldwide for the three and nine months ended September 30, 2025, was $ 6.5 million and $ 19.6 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.
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, 2025, 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. In October 2025, the parties amended the agreement to enable Lilly to commercialize baricitinib for the treatment of Type 1 diabetes mellitus and to restructure the royalty obligations on net sales of baricitinib, certain developmental and regulatory milestones associated with baricitinib, and the marketing and sales support obligations of Lilly, for which we will receive an upfront payment of $ 100.0 million. Beginning in October 2025, we are now eligible to receive either a fixed royalty amount or tiered royalties based on defined levels of quarterly global net sales, with the tiered royalties up to a rate in the mid-teens.
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Product royalty revenue related to Lilly net sales of OLUMIANT outside of the United States for the three and nine months ended September 30, 2025 was $ 37.1 million and $ 101.4 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, 2024 was $ 34.8 million and $ 97.1 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 agreed to collaborate on the discovery of novel immuno-therapeutics using Agenus’ antibody discovery platforms. In February 2025, we provided Agenus with notice that we are terminating the parties’ agreement based upon a strategic review. Under the terms of the agreement, the termination will become effective in February 2026, unless Agenus agrees to accelerate the notice period.
During 2024, we sold our shares of Agenus Inc. common stock, and as of December 31, 2024, we had no remaining investment in Agenus Inc. common stock. 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.
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.
During 2024, we sold our investment of Merus’ common shares, and as of December 31, 2024, we had no remaining investment in Merus’ common shares. 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.
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.
Since the inception of the agreement, inclusive of amendments to the agreement, through September 30, 2025, 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. In June 2025, MacroGenics sold certain of its rights to such future tiered royalties on and after June 30, 2025 to Sagard Healthcare Partners (Delaware) II LP.
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.
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During 2024, we sold our investment of MorphoSys AG’s ordinary shares, and as of December 31, 2024, we had no remaining investment in MorphoSys AG’s ordinary shares. 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 respective periods.
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. 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.
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”). Under the terms of our agreement, we received exclusive commercialization rights to axatilimab outside of the United States and share commercialization rights in the United States with Syndax. We are responsible for leading the commercialization strategy and booking all revenue from sales of axatilimab globally. Incyte and Syndax share equally the profits and losses from the co-commercialization efforts in the United States. Sales of axatilimab outside the United States are subject to our royalty payment obligations to Syndax, as set forth below. 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, 2025, 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, 2025, 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. Syndax’s right to receive royalties in any particular country will expire upon the last to occur of (a) the expiration of patent rights in that particular country, (b) a specified period of time after the first post-marketing authorization sale of a licensed product comprising axatilimab in that country, and (c) the expiration of any regulatory exclusivity for that licensed product in that country.
As of September 30, 2025, 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, 2025 and December 31, 2024 was $ 21.9 million and $ 18.8 million, respectively. For the three and nine months ended September 30, 2025, we recorded an unrealized gain of $ 8.6 million and $ 3.1 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, 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.
Research and development expenses for the three and nine months ended September 30, 2025, includes $ 6.3 million and $ 16.3 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, 2024, includes $ 5.8 million and $ 17.6 million, respectively, related to our 55 % share of the co-development costs for axatilimab. At September 30, 2025 and December 31, 2024, $ 1.7 million and $ 2.2 million, respectively, was included in accrued and other liabilities on the condensed consolidated balance sheet for amounts due to Syndax under the agreement.
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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.
Sun Pharmaceuticals, Inc.
In July 2025, we entered into a settlement and license agreement with Sun Pharmaceuticals, Inc. ("Sun"), resolving patent infringement litigation related to Leqselvi (deuruxolitinib). Under this agreement, we have granted Sun a limited, non-exclusive license in the U.S. with respect to oral deuruxolitinib for certain agreed-upon non-hematology-oncology indications, including alopecia areata. In exchange for the limited license, Sun has paid us an upfront payment upon our transfer of functional intellectual property, which is included in milestone and contract revenues on the condensed consolidated statement of operations for the three and nine months ended September 30, 2025, and has agreed to pay to us ongoing royalty payments. The amount associated with the settlement component is de minimis.
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,
2025 December 31,
2024
Office equipment $ 24,388 $ 23,710
Laboratory equipment 252,268 229,797
Computer equipment 148,723 156,859
Land 16,101 15,395
Building and leasehold improvements 627,938 597,342
Operating lease right-of-use assets 20,113 22,230
Construction in progress 69,706 46,062
1,159,237 1,091,395
Less accumulated depreciation and amortization ( 360,603 ) ( 327,984 )
Property and equipment, net $ 798,634 $ 763,411
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 year ended December 31, 2024, we capitalized $ 4.9 million of land and $ 19.5 million of building and parking garage. As of September 30, 2025 we have $ 48.1 million of construction in progress relating to the downtown Wilmington properties.
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Note 10. Accrued and Other Current Liabilities
Accrued and other current liabilities consisted of the following (in thousands):
September 30,
2025 December 31,
2024
Royalties $ 36,937 $ 519,881
Clinical related costs 157,684 132,446
Sales allowances 599,863 438,053
Sales and marketing 48,912 33,439
Accrued taxes 5,512 23,781
Operating lease liabilities 5,895 5,583
Other current liabilities 93,636 58,865
Total accrued and other current liabilities $ 948,439 $ 1,212,048
For further information on the change in accrued royalties refer to Note 8.
Note 11. Stockholders' Equity
2010 Stock Incentive Plan. Under our Amended and Restated 2010 Stock Incentive Plan, as amended (the “2010 Stock Plan”), we may issue 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”).
In June 2025, our stockholders approved an increase in the number of shares of common stock reserved for issuance under the 2010 Stock Plan from 66,453,475 to 74,953,475 .
2024 Inducement Stock Incentive Plan. Our Board of Directors has adopted the Incyte Corporation 2024 Inducement Stock Incentive Plan, as amended (the “2024 Inducement Plan”). In reliance on Nasdaq Marketplace Rule 5635(c)(4), stockholder approval was not obtained. A total of 2,000,000 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 was 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.
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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 $ 19.1 million for excise taxes on share repurchases in accordance with the Inflation Reduction Act of 2022. We paid the excise tax in April 2025. These costs are recognized within (accumulated deficit) retained earnings on the condensed consolidated balance sheet as of September 30, 2025 as costs to repurchase our common stock. The purchased shares were cancelled and ceased to be outstanding.
Note 12. Other Comprehensive Income (Loss)
The following tables summarize the activity related to each component of other comprehensive income (loss) during the nine months ended September 30, 2025 and 2024:
(Amounts presented net of taxes) Foreign Currency Translation Gains (Loss) Net Unrealized Gains (Losses) on Marketable Securities Defined Benefit Pension Plans Accumulated Other Comprehensive Gain (Loss)
Balances at January 1, 2025 $ 26,457 $ 346 $ ( 39,924 ) $ ( 13,121 )
Other comprehensive income before reclassifications 24,661 1,342 — 26,003
Net amount reclassified from accumulated other comprehensive loss — — 1,673 1,673
Net other comprehensive income 24,661 1,342 1,673 27,676
Balances at September 30, 2025 $ 51,118 $ 1,688 $ ( 38,251 ) $ 14,555
(Amounts presented net of taxes) Foreign Currency Translation Gains (Loss) Net Unrealized Gains (Losses) on Marketable Securities Defined Benefit Pension Plans Accumulated Other Comprehensive Gain (Loss)
Balances at January 1, 2024 $ 44,181 $ ( 149 ) $ ( 30,926 ) $ 13,106
Other comprehensive (loss) income before reclassifications ( 2,185 ) 3,463 — 1,278
Net amount reclassified from accumulated other comprehensive loss — — 1,271 1,271
Net other comprehensive (loss) income ( 2,185 ) 3,463 1,271 2,549
Balances at September 30, 2024 $ 41,996 $ 3,314 $ ( 29,655 ) $ 15,655
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Note 13. Stock Compensation
We recorded $ 61.6 million and $ 187.2 million of stock compensation expense on our condensed consolidated statements of operations for the three and nine months ended September 30, 2025, respectively. 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. Stock compensation expense included within our condensed consolidated statements of operations included research and development expense of $ 39.7 million, $ 114.1 million, $ 45.8 million and $ 117.1 million for the three and nine months ended September 30, 2025 and 2024, respectively. Stock compensation expense included within our condensed consolidated statements of operations also included selling, general and administrative expense of $ 21.0 million, $ 70.5 million, $ 31.5 million and $ 75.6 million for the three and nine months ended September 30, 2025 and 2024, respectively. Stock compensation expense included within our condensed consolidated statements of operations also included cost of product revenues of $ 0.9 million, $ 2.6 million, $ 0.6 million and $ 1.6 million respectively, for the three and nine months ended September 30, 2025 and 2024.
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 $ 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,
2025 2024 2025 2024 2025 2024 2025 2024
Average risk-free interest rates 3.99 % 4.18 % 4.13 % 4.15 % 3.83 % 4.38 % 4.03 % 4.96 %
Average expected life (in years) 5.17 5.17 5.01 5.02 0.50 0.50 0.50 0.50
Volatility 29 % 29 % 29 % 30 % 32 % 28 % 35 % 24 %
Weighted-average fair value (in dollars) $ 23.58 $ 21.54 $ 23.45 $ 21.02 $ 14.72 $ 12.11 $ 14.95 $ 11.27
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, 2024 12,777,974 $ 83.45
Options granted 1,331,262 $ 71.04
Options exercised ( 667,616 ) $ 71.32
Options cancelled ( 590,480 ) $ 82.55
Balance at September 30, 2025 12,851,140 $ 82.83
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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, 2024 8,656,803 $ 67.81
RSUs granted 3,422,768 $ 68.71
PSUs granted 873,728 $ 56.72
Additional PSUs earned 32,148 $ 70.45
RSUs released ( 2,500,344 ) $ 71.11
PSUs released ( 143,776 ) $ 77.67
RSUs cancelled ( 341,581 ) $ 67.18
PSUs cancelled ( 124,489 ) $ 75.76
Balance at September 30, 2025 9,875,257 $ 66.59
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 six 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, 2025 we recorded $ 2.6 million and $ 12.6 million, respectively, of stock compensation expense for PSUs on our condensed consolidated statements of operations. 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.
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The following table summarizes our shares available for grant under the 2010 Stock Plan and 2024 Inducement Plan. Previously, each RSU and PSU grant reduced the available share pool by 2 shares. In June 2025, our stockholders approved an amendment to the 2010 Stock Plan to remove the fungible ratio, and all awards granted under the 2010 Stock Plan after June 10, 2025, the date of our latest annual meeting, will reduce the share reserve on a one -for-one basis. If awards granted under the 2010 Stock Plan on or prior to June 10, 2025 expire, become unexercisable or are forfeited or repurchased after that date, the shares that were subject to those awards will become available for future grant only on a one -for-one basis, even if the original award was a full value award that reduced the share reserve on a two -for-one basis. The 2024 Inducement Plan was amended in June 2025 to remove the provision that stated that any shares issued in connection with awards other than options and stock appreciation rights will be counted against the authorized share limitation as 2.0 shares for every one share so issued and, as a result, all awards granted under the 2024 Inducement Plan will reduce the share reserve thereunder on a one -for-one basis.
Shares Available
for Grant
Balance at December 31, 2024 4,013,611
Additional authorization - 2010 Stock Plan 8,500,000
Additional authorization - 2024 Inducement Plan 1,000,000
Options, RSUs and PSUs granted and issuance of shares for services rendered ( 6,140,010 )
Options, RSUs and PSUs cancelled 1,217,120
Fungible ratio change adjustments 282,731
Balance at September 30, 2025 8,873,452
We estimate an annualized forfeiture rate 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, 2025, was $ 25.6 million, which is expected to be recognized over the weighted average period of approximately 1.4 years. Total compensation cost of RSUs granted but not yet vested, as of September 30, 2025, was $ 299.9 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, 2025, was $ 43.9 million, which is expected to be recognized over the weighted average period of 2.4 years, should the underlying performance conditions be deemed probable of achievement.
Note 14. Income Taxes
For the three and nine months ended September 30, 2025 and 2024, 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,
2025 2024 2025 2024
Income before provision for income taxes $ 482,308 $ 156,524 $ 1,274,510 $ 2,906
Provision for income taxes 58,139 50,068 287,139 171,503
Effective tax rate 12.1 % 32.0 % 22.5 % 5,901.7 %
Our effective tax rate for the three months ended September 30, 2025 is lower than the U.S. statutory rate primarily due to a net decrease in our valuation allowance against certain U.S. federal deferred tax assets, resulting from the recently enacted U.S. tax law changes described below. Our effective tax rate for the nine months ended September 30, 2025 was higher than the U.S. statutory rate primarily due to 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, the foreign derived intangible income deduction and a decrease in a prior year valuation allowance against certain U.S. federal deferred tax assets, resulting from the recently enacted U.S. tax law changes.
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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.
The effective tax rate for the three months ended September 30, 2025 was favorable as compared to the three months ended September 30, 2024 primarily due to the decrease in the valuation allowance against certain U.S. Federal deferred tax assets, resulting from recently enacted U.S. tax law changes described below. The effective tax rate for the nine months ended September 30, 2025 was favorable as compared to the nine months ended September 30, 2024 primarily due to the non-deductible charge associated with the Escient acquisition in the prior year period.
We accrue interest and penalties related to unrecognized tax benefits as a component of the provision for income taxes.
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 2021. We are currently under U.S. federal audit for tax year 2021.
The Organization for Economic Cooperation and Development Pillar 2 guidelines, supported by over 130 countries worldwide, establish a 15% global minimum tax on adjusted financial results. Pillar 2 legislation has been enacted in multiple jurisdictions in which we operate and became effective beginning in 2024. We have evaluated the impact of Pillar 2 on our business, and determined there are no material impacts on our effective tax rate at this time. We will continue to monitor additional enactments and guidance as they occur and assess any future impacts in the period they become effective.
On July 4, 2025, the U.S. enacted legislation formally titled “An Act to Provide for Reconciliation Pursuant to Title II of H. Con. Res. 14” and commonly referred to as the One Big Beautiful Bill Act (“OBBBA”). The OBBBA modified key provisions of the Tax Cuts and Jobs Act of 2017, including but not limited to, the expensing of domestic research costs, the deduction for Foreign-Derived Intangible Income, and the Global Intangible Low-Taxed Income regime. The OBBBA introduces multiple elections and features various effective dates, with some provisions effective in 2025 and others in subsequent years.
Under ASC 740, entities are required to recognize the impact of new income tax legislation in the period of enactment. We continue to evaluate the OBBBA’s various provisions and elections, including their expected favorable impact on our effective tax rate and the realizability of deferred tax assets, and have reflected an estimate of these effects in our financial statements for the period ending September 30, 2025.
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Note 15. 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,
2025 2024 2025 2024
Basic net income (loss) $ 424,169 $ 106,456 $ 987,371 $ ( 168,597 )
Weighted average common shares outstanding 195,670 192,629 194,459 211,763
Basic net income (loss) per share $ 2.17 $ 0.55 $ 5.08 $ ( 0.80 )
Diluted net income (loss) $ 424,169 $ 106,456 $ 987,371 $ ( 168,597 )
Weighted average common shares outstanding 195,670 192,629 194,459 211,763
Dilutive stock options and awards 5,759 3,209 4,946 —
Weighted average shares used to compute diluted net income (loss) per share 201,429 195,838 199,405 211,763
Diluted net income (loss) per share $ 2.11 $ 0.54 $ 4.95 $ ( 0.80 )
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,
2025 2024 2025 2024
Outstanding stock options and awards 8,111,846 13,067,516 11,064,833 16,881,330
Note 16. 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, 2025 was $ 5.8 million and $ 17.3 million, respectively. Defined contribution expense for the three and nine months ended September 30, 2024 was $ 5.2 million and $ 15.8 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.
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The net periodic benefit cost was as follows (in thousands):
Three Months Ended
September 30, Nine Months Ended
September 30,
2025 2024 2025 2024
Service cost $ 4,068 $ 2,537 $ 11,674 $ 7,815
Interest cost 489 750 1,402 1,977
Expected return on plan assets ( 1,867 ) ( 1,871 ) ( 5,358 ) ( 5,315 )
Amortization of prior service cost 228 217 648 624
Amortization of actuarial losses 357 167 1,025 647
Net periodic benefit cost $ 3,275 $ 1,800 $ 9,391 $ 5,748
The components of net periodic benefit cost other than the service cost component are included in Other, net on the condensed consolidated statements of operations. We expect to contribute a total of $ 10.1 million to the pension plans in 2025 inclusive of the amounts contributed to the plan during the current period.
Note 17. 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.
Loans under the Credit Agreement will bear interest, at our option, at a per annum rate equal to either (a) a base rate (but not less than 1.00 %) plus an applicable rate per annum varying from 0.125 % to 0.875 % depending on our consolidated leverage ratio or (b) a rate based on the secured overnight financing rate (“SOFR”) plus a credit spread adjustment of 0.10 % (but not less than 0.00 %), plus an applicable rate per annum varying from 1.125 % to 1.875 % depending on our consolidated leverage ratio. Commitment fees payable on the undrawn commitment range from 0.15 % per annum to 0.225 % per annum, based on our consolidated leverage ratio. We may, at our option, prepay any borrowings under the Credit Agreement, in whole or in part, at any time and from time to time without premium or penalty, subject to customary exceptions. As of September 30, 2025 and December 31, 2024, we had no outstanding borrowings and were in compliance with all covenants under this facility.
Contingencies
In the ordinary course of our business, we may become involved in lawsuits, proceedings, and other disputes, including commercial, intellectual property, regulatory, employment, and other matters. The outcome of these disputes, regardless of the merits, is inherently uncertain and it is possible that an unfavorable resolution of these matters could adversely affect us, our results of operations, financial condition or cash flows. We record a reserve for these matters when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated.
We have entered into the collaboration agreements described in Note 8, as well as various other collaboration agreements that are not individually, or in the aggregate, significant to our operating results or financial condition at this time. We may in the future seek to license additional rights relating to technologies or drug development candidates in connection with our drug discovery and development programs. Under these agreements, we may be required to pay upfront fees, milestone payments, and royalties on sales of future products.
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We brought a lawsuit against the U.S. Centers for Medicare and Medicaid Services (“CMS”) alleging that a regulation issued by CMS on the definition of “line extension” for purposes of the Medicaid rebate program is too broad and has the unintended consequence of treating OPZELURA as a “line extension” of JAKAFI under this program. We believe that such a reading would violate CMS’s statutory authority and be arbitrary and capricious given that OPZELURA, among other differentiators, is indicated to treat entirely different medical conditions and entirely different patient populations than JAKAFI. As of September 30, 2025, we have accrued approximately $ 188.9 million within accrued and other current liabilities on the condensed consolidated balance sheet, relating to the incremental rebates that would be owed were OPZELURA considered a line extension of JAKAFI. The impact on OPZELURA gross to net deductions for the quarter ending September 30, 2025 is approximately 6.8 %. If OPZELURA is not treated as a line extension of JAKAFI, this would result in a reversal of our accrual and a lower future gross to net deduction for OPZELURA.
In addition, we have various patent disputes and litigation initiated by us related to potential generic or other competition for our products, as described under Part II, Item 1A. “Risk Factors—Risks Relating to Commercialization of Our Products— Competition for our products could harm our business and result in a decrease in our revenue” below. Additionally, as described in Note 8, we entered into a settlement and license agreement with Sun, resolving patent infringement litigation related to Leqselvi (deuruxolitinib).
Note 18. Segment Information
We operate in one operating segment, and therefore one reportable segment, focused on the global discovery, development and commercialization of proprietary therapeutics. We manage business activities on a consolidated basis through the development and commercialization of oncology and dermatology products, which are sold to U.S. and international customers. Our determination that we operate as a single operating segment is consistent with the financial information regularly reviewed by the chief operating decision maker for purposes of evaluating performance, allocating resources, setting incentive compensation targets, and planning and forecasting for future periods. Our chief operating decision maker is the Chief Executive Officer.
The accounting policies for our single operating segment are the same as those described in the summary of significant accounting policies in our Annual Report on Form 10-K for the year ended December 31, 2024. Our single operating segment generates revenues from the development and commercialization of oncology and dermatology pharmaceutical products, which are developed by our research and development department, as well as from product royalties, milestone and contract revenues from the out-licensing of our intellectual property to third parties.
For our segment, the chief operating decision maker uses net income or loss, that also is reported on the condensed consolidated statements of operations as consolidated net income, to allocate resources (including employees, property, and financial resources), predominantly during the annual budget and forecasting process. The chief operating decision maker also uses consolidated net income or loss, along with non-financial inputs and qualitative information, to evaluate our performance, establish compensation, monitor budget versus actual results, and decide the level of investment in our various operating activities and other capital allocation activities. The measure of segment assets is reported on the condensed consolidated balance sheet as total consolidated assets.
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Net income for our segment was as follows (in thousands):
Three Months Ended
September 30, Nine Months Ended
September 30,
2025 2024 2025 2024
Product revenues, net $ 1,149,856 $ 962,992 $ 3,131,544 $ 2,599,481
Product royalty revenues 171,124 156,879 452,863 420,038
Milestone and contract revenues 45,000 18,000 50,000 43,000
Total revenues 1,365,980 1,137,871 3,634,407 3,062,519
Costs, expenses and other:
Cost of product revenues (including definite-lived intangible amortization) 99,001 85,993 250,955 223,583
Contract dispute settlement — — ( 242,251 ) —
Research and development - internal 1
250,140 250,477 715,171 707,208
Research and development - external 2
256,344 222,697 695,459 652,805
Other research and development 3
100 100,000 28,150 780,801
Sales and marketing 272,302 241,880 786,265 687,896
General and administrative 56,779 67,329 199,529 227,551
(Gain) loss on change in fair value of acquisition-related contingent consideration ( 12,204 ) 23,410 22,129 23,847
(Profit) and loss sharing under collaboration agreements — — — ( 1,025 )
Other segment items 4
19,349 39,629 191,629 ( 71,550 )
Net income (loss) $ 424,169 $ 106,456 $ 987,371 $ ( 168,597 )
1. Research and development - internal is comprised of internally generated costs such as salaries, travel, regulatory costs, lab costs, contracting, etc.
2. Research and development - external is comprised of specific program spend with external vendors (i.e. contract manufacturing organizations, contract research organizations and lab vendors for clinical, technical operations and toxicology services).
3. Other research and development is comprised of all other costs including certain one-time costs resulting from the acquisition of IPR&D assets and one-time development milestone expenses.
4. Other segment items is comprised of interest income, interest expense, realized and unrealized (gain) loss on equity investments, other, net, and provision for income taxes .
Total Revenues by Geographic Location
Total revenues by geographic region consisted of the following (in thousands):
Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
United States $ 1,261,261 $ 1,070,040 $ 3,375,171 $ 2,887,233
Europe 100,306 66,464 247,744 171,581
Other countries 4,413 1,367 11,492 3,705
Total revenues $ 1,365,980 $ 1,137,871 $ 3,634,407 $ 3,062,519
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Property and Equipment, Net by Geographic Location
Property and equipment, net by geographic location was as follows (in thousands):
September 30,
2025 December 31,
2024
United States $ 477,059 $ 474,095
Switzerland 308,107 277,623
Other countries 13,468 11,693
Total property and equipment, net $ 798,634 $ 763,411
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion of our financial condition and results of operations as of and for the three and nine months ended September 30, 2025 should be read in conjunction with the unaudited condensed consolidated financial statements and notes to those statements included elsewhere in this Quarterly Report on Form 10-Q and our audited consolidated financial statements as of and for the year ended December 31, 2024 included in our Annual Report on Form 10-K for the year ended December 31, 2024 previously filed with the SEC.
Forward-Looking Statements
This report contains forward-looking statements that involve risks and uncertainties. These statements relate to future periods, future events or our future operating or financial plans or performance. Often, these statements include the words “believe,” “expect,” “target,” “anticipate,” “intend,” “plan,” “seek,” “estimate,” “potential,” or words of similar meaning, or future or conditional verbs such as “will,” “would,” “should,” “could,” “might,” or “may,” or the negative of these terms, and other similar expressions. These forward-looking statements include, among other things, statements as to:
• the discovery, development, formulation, manufacturing and commercialization of our compounds, our drug candidates and JAKAFI ® /JAKAVI ® (ruxolitinib), PEMAZYRE ® (pemigatinib), ICLUSIG ® (ponatinib), MONJUVI ® (tafasitamab-cxix) / MINJUVI ® (tafasitamab), OPZELURA ® (ruxolitinib) cream, ZYNYZ ® (retifanlimab-dlwr) and NIKTIMVO TM (axatilimab);
• our collaboration and strategic relationship strategy, and anticipated benefits and disadvantages of entering into collaboration agreements;
• our licensing, investment and commercialization strategies, including our plans to commercialize our drug products and drug candidates;
• the regulatory approval process, including obtaining U.S. Food and Drug Administration and other international regulatory authorities’ approval for our products in the United States and abroad;
• the safety, effectiveness and potential benefits and indications of our drug candidates and other compounds under development;
• the timing, structure and size of our clinical trials; the compounds expected to enter clinical trials; the timing of clinical trial results;
• our ability to manage expansion of our drug discovery and development operations;
• future required expertise relating to clinical trials, manufacturing, sales and marketing;
• obtaining and terminating licenses to products, drug candidates or technology, or other intellectual property rights;
• the receipt from or payments pursuant to collaboration or license agreements resulting from milestones or royalties;
• plans to develop and commercialize products on our own;
• plans for our manufacturing operations, including plans to use third-party manufacturers;
• expected expenses and expenditure levels; expected uses of cash; expectations with respect to the need or ability to raise additional capital; expected revenues and sources of revenues; expectations with respect to inventory;
• expectations with respect to reimbursement for our products;
• the expected impact of recent accounting pronouncements and changes in tax laws;
• expected losses; fluctuation of losses; currency translation impact associated with non-U.S. operations and collaboration royalties;
• our profitability; the adequacy of our capital resources to continue operations;
• the costs and other financial impacts associated with resolving matters in litigation and governmental proceedings;
• our expectations regarding competition;
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• our investments, including anticipated expenditures, losses and expenses; and
• our patent prosecution and maintenance efforts.
These forward-looking statements reflect our current views with respect to future events, are based on assumptions and are subject to risks and uncertainties. These risks and uncertainties could cause actual results to differ materially from those projected and include, but are not limited to:
• our ability to discover, develop, formulate, manufacture and successfully commercialize our drug products and drug candidates;
• our ability to obtain, or maintain at anticipated levels, coverage and reimbursement for our products from government health administration authorities, private health insurers and other organizations;
• risks relating to changes in pricing and reimbursement in the markets in which we compete;
• our ability to establish and maintain effective sales, marketing and distribution capabilities;
• our ability to obtain and maintain regulatory approvals to market our products;
• our ability to achieve a significant market share in order to achieve or maintain profitability;
• the risk of civil or criminal penalties if we market our products in a manner that violates health care fraud and abuse and other applicable laws, rules and regulations;
• the risk of unanticipated delays in, or discontinuations of, research and development efforts;
• the risk that previous preclinical testing or clinical trial results are not necessarily indicative of future clinical trial results;
• risks relating to the conduct of our clinical trials, including geopolitical risks;
• changing regulatory requirements;
• the risk of adverse safety findings;
• the risk that results of our clinical trials do not support submission of a marketing approval application for our drug candidates;
• risks relating to our reliance on third-party manufacturers, collaborators, and clinical research organizations;
• risks relating to the development of new products and their use by us and our current and potential collaborators;
• our ability to maintain or obtain adequate product liability and other insurance coverage;
• the impact of technological advances and competition to develop and commercialize similar drug products, including potential generic competition;
• our ability to obtain and maintain patent protection and freedom to operate for our discoveries and to continue to be effective in prosecuting, maintaining, defending and enforcing patent claims and other intellectual property rights;
• the impact of changing laws on our patent portfolio;
• developments in, and expenses relating to, litigation and governmental proceedings;
• our ability to in-license drug candidates or other technology;
• unanticipated delays or changes in plans or regulatory agency interactions or other issues relating to our large molecule production facility;
• the impact of tariffs and trade conflicts and the effects of any economic slowdown;
• our ability to integrate successfully acquired businesses, development programs or technology;
• our ability to obtain additional capital when needed;
• fluctuations in net cash provided and used by operating, financing and investing activities;
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• changes in tax laws and regulations and our ability to analyze the effects of new accounting pronouncements and apply new accounting rules;
• risks relating to our ability to sustain profitability;
• risks related to public health pandemics such as the COVID-19 pandemic, natural disasters, or geopolitical events such as the Russian invasion of Ukraine and conflicts in the Middle East; and
• the risks set forth under “Risk Factors” in Item 1A of this Quarterly Report on Form 10-Q.
Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by federal securities laws, we undertake no obligation to update any forward-looking statements for any reason, even if new information becomes available or other events occur in the future.
In this report all references to “Incyte,” “we,” “us,” “our” or the “Company” mean Incyte Corporation and our subsidiaries, except where it is made clear that the term means only the parent company.
Incyte, JAKAFI, MINJUVI, MONJUVI, OPZELURA, PEMAZYRE and ZYNYZ are our registered trademarks and NIKTIMVO is our trademark. We also refer to trademarks of other corporations and organizations in this Quarterly Report on Form 10-Q.
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Summary Risk Factors
Our business is subject to numerous risks and uncertainties that could affect our ability to successfully implement our business strategy and affect our financial results. You should carefully consider all of the information in this report and, in particular, the following principal risks and all of the other specific factors described in Item 1A. “Risk Factors” of this report before deciding whether to invest in our company.
• We depend heavily on JAKAFI/JAKAVI (ruxolitinib), and if we are not able to maintain revenues from JAKAFI/JAKAVI or those revenues decrease, our business may be materially harmed.
• If we or our collaborators are unable to obtain, or maintain at anticipated levels, coverage and reimbursement for our products from government and other third-party payors, our results of operations and financial condition could be harmed.
• A limited number of specialty pharmacies and wholesalers represent a significant portion of revenues from JAKAFI and most of our other products, and the loss of, or significant reduction in sales to, any one of these specialty pharmacies or wholesalers could harm our operations and financial condition.
• If we are unable to establish and maintain effective sales, marketing and distribution capabilities, or to enter into agreements with third parties to do so, we will not be able to successfully commercialize our products.
• If we fail to comply with applicable laws and regulations, we could lose our approval to market our products or be subject to other governmental enforcement activity.
• If the use of our products harms or is perceived to harm patients, our regulatory approvals could be revoked or otherwise negatively impacted or we could be subject to costly product liability claims.
• If we market our products in a manner that violates various laws and regulations, we may be subject to civil or criminal penalties.
• Competition for our products could harm our business and result in a decrease in our revenue.
• We or our collaborators may be unsuccessful in discovering and developing drug candidates, and we may spend significant time and money attempting to do so, in particular with our later stage drug candidates.
• If we or our collaborators are unable to obtain regulatory approval in and outside of the United States for drug candidates, we and our collaborators will be unable to commercialize those drug candidates.
• Health care reform measures could impact the pricing and profitability of pharmaceuticals, and adversely affect the commercial viability of our or our collaborators’ products and drug candidates.
• Conflicts between us and our collaborators or termination of our collaboration agreements could limit future development and commercialization of our drug candidates and harm our business.
• If we are unable to establish collaborations to fully exploit our drug discovery and development capabilities or if future collaborations are unsuccessful, our future revenue prospects could be diminished.
• If we fail to enter into additional in-licensing agreements or if these arrangements are unsuccessful, we may be unable to increase our number of successfully marketed products and our revenues.
• Business disruptions, including those resulting from public health pandemics, natural disasters, and other geopolitical events, could adversely affect our business and results of operations.
• Even if one of our drug candidates receives regulatory approval, we may determine that commercialization would not be worth the investment.
• We have limited capacity to conduct preclinical testing and clinical trials, and our resulting dependence on other parties could result in delays in and additional costs for our drug development efforts.
• Our reliance on others to manufacture our drug products and drug candidates could result in drug supply constraints, delays in clinical trials, increased costs, and withdrawal or denial of regulatory approvals.
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• If we fail to comply with the extensive legal and regulatory requirements affecting the health care industry, we could face increased costs, penalties and a loss of business.
• The illegal distribution and sale by third parties of counterfeit or unfit versions of our or our collaborators’ products or stolen products could harm our business and reputation.
• As most of our drug discovery and development operations are conducted at our headquarters in Wilmington, Delaware, the loss of access to this facility would negatively impact our business.
• If we lose any of our key employees or are unable to attract and retain additional personnel, our business and ability to achieve our objectives could be harmed.
• If we fail to manage our growth effectively, our ability to develop and commercialize products could suffer.
• We may acquire businesses or assets, form joint ventures or make investments in other companies that may be unsuccessful, divert our management’s attention and harm our operating results and prospects.
• Risks associated with our operations outside of the United States could adversely affect our business.
• If product liability lawsuits are brought against us, we could face substantial liabilities and may be required to limit commercialization of our products, and our results of operations could be harmed.
• Because our activities involve the use of hazardous materials, we may be subject to claims relating to improper handling, storage or disposal of these materials that could be time consuming and costly.
• We expect to continue to incur significant expenses to discover and develop drugs, which could result in future losses and impair our achievement of and ability to sustain profitability in the future.
• If we are unable to raise additional capital in the future when we require it, our efforts to broaden our product portfolio or commercialization efforts could be limited.
• Our marketable securities and equity investments are subject to risks that could adversely affect our overall financial position, and tax law changes could adversely affect our results of operations and financial condition.
• If we are unable to achieve milestones, develop product candidates to license or renew or enter into new collaborations, our royalty and milestone revenues and future prospects for those revenues may decrease.
• Any arbitration or litigation involving us and regarding intellectual property infringement claims could be costly and disrupt our drug discovery and development efforts.
• Our inability to adequately protect or enforce our proprietary information may result in loss of revenues or otherwise reduce our ability to compete.
• If the effective term of our patents is decreased or if we need to refile some of our patent applications, the value of our patent portfolio and the revenues we derive from it may be decreased.
• International patent protection is particularly uncertain and costly, and our involvement in opposition proceedings may result in the expenditure of substantial sums and management resources.
• Significant disruptions of information technology systems, breaches of data security, or unauthorized disclosures of sensitive data could harm our business and subject us to liability or reputational damage.
• Increasing use of social media and new technology could give rise to liability, breaches of data security, or reputational damage, which could harm our business and results of operations.
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Overview
Incyte is a global biopharmaceutical company engaged in the discovery, development and commercialization of proprietary therapeutics. Our global headquarters is located in Wilmington, Delaware, where we conduct discovery, clinical development and commercial operations. We also conduct clinical development and commercial operations from our European headquarters in Morges, Switzerland and our other offices across Europe, as well as our Japanese office in Tokyo and our Canadian headquarters in Montreal.
We are focused in two therapeutic areas that are defined by the indications of our approved medicines and the diseases for which our clinical candidates are being developed. One therapeutic area is Hematology/Oncology, which comprises Myeloproliferative Neoplasms (“MPNs”), Graft-Versus-Host Disease (“GVHD”), solid tumors and hematologic malignancies. The other therapeutic area is Inflammation and Autoimmunity (“IAI”), which includes our Dermatology franchise. We are also eligible to receive milestones and royalties on molecules discovered by us and licensed to third parties.
Hematology and Oncology
Our hematology and oncology franchise comprises six approved products, which are JAKAFI (ruxolitinib), MONJUVI (tafasitamab-cxix)/MINJUVI (tafasitamab), PEMAZYRE (pemigatinib), ICLUSIG (ponatinib), ZYNYZ (retifanlimab-dlwr), and NIKTIMVO (axatilimab-csfr), as well as numerous clinical development programs.
Approved Products
JAKAFI (ruxolitinib)
JAKAFI (ruxolitinib) is our first product to be approved for sale in the United States. JAKAFI is the most advanced compound in our janus associated kinase (“JAK”) program and is an oral JAK1 and JAK2 inhibitor. It was approved by the U.S. Food and Drug Administration (“FDA”) in November 2011 for the treatment of adults with intermediate or high-risk myelofibrosis (“MF”); in December 2014 for the treatment of adults with polycythemia vera (“PV”) who have had an inadequate response to or are intolerant of hydroxyurea; in May 2019 for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and in September 2021 for the treatment of chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older . MF and PV are both MPNs, a group of rare blood cancers, and GVHD is an adverse immune response to an allogeneic hematopoietic stem cell transplant. Under our collaboration agreement with our collaboration partner Novartis Pharmaceutical International Ltd. (“Novartis”), Novartis received exclusive development and commercialization rights to ruxolitinib outside of the United States for all hematologic and oncologic indications and sells ruxolitinib outside of the United States under the name JAKAVI.
JAKAFI was the first FDA-approved JAK inhibitor for any indication, was the first FDA-approved product in MF, PV and steroid-refractory acute GVHD, and was recently approved in steroid-refractory chronic GVHD. JAKAFI remains the first-line standard of care in MF and remains the only FDA-approved product for steroid-refractory acute GVHD. The FDA has granted JAKAFI orphan drug status for MF, PV and GVHD. In addition, ruxolitinib phosphate qualifies for the Small Biotech Exception from the Centers for Medicare and Medicaid Services (“CMS”) under the Inflation Reduction Act.
JAKAFI is distributed primarily through a network of specialty pharmacy providers and wholesalers that allow for efficient delivery of the medication by mail directly to patients or direct delivery to the patient's pharmacy. Our distribution process uses a model that is well established and familiar to physicians who practice within the oncology field.
We have retained all development and commercialization rights to JAKAFI in the United States and are eligible to receive development and sales milestones as well as royalties from product sales outside the United States. We hold patents that cover the composition of matter and use of ruxolitinib and its salt. These patents, including applicable extensions, currently expire in mid and late 2028. In December 2022, we were granted pediatric exclusivity, which adds six months to the expiration for all ruxolitinib patents listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) as of the date of the grant of pediatric exclusivity.
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MONJUVI (tafasitamab-cxix) / MINJUVI (tafasitamab)
In January 2020, we and MorphoSys AG (“MorphoSys”) entered into a collaboration and license agreement to further develop and commercialize MorphoSys’ proprietary anti-CD19 antibody tafasitamab (MOR208), an Fc-engineered antibody against CD19. Under the terms of the collaboration and license agreement, we received rights to co-commercialize tafasitamab in the United States with MorphoSys, and exclusive development and commercialization rights outside of the United States. As more fully described in Note 6 of Notes to the Condensed Consolidated Financial Statements, in February 2024, we entered into a purchase agreement with MorphoSys, and as a result, we now hold exclusive global rights for tafasitamab, and the collaboration and license agreement was terminated.
In July 2020, the FDA approved MONJUVI (tafasitamab-cxix), in combination with lenalidomide, for the treatment of adult patients with relapsed or refractory (“r/r”) diffuse large B-cell lymphoma (“DLBCL”) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (“ASCT”). In August 2021, the European Commission granted conditional marketing authorization for MINJUVI (tafasitamab), in combination with lenalidomide, followed by MINJUVI monotherapy, for the treatment of adult patients with r/r DLBCL who are not eligible for ASCT. In June 2025, MONJUVI (tafasitamab-cxix) was approved by the FDA for the treatment of adult patients with r/r follicular lymphoma (“FL”) in combination with rituximab and lenalidomide.
PEMAZYRE (pemigatinib)
PEMAZYRE is the first internally discovered product to be internationally commercialized by us.
In April 2020, the FDA approved PEMAZYRE (pemigatinib), a selective fibroblast growth factor receptor (FGFR) kinase inhibitor, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test. PEMAZYRE is the first FDA-approved treatment for this indication, which was approved under accelerated approval based on overall response rate and duration of response.
In March 2021, PEMAZYRE was approved by the Japanese Ministry of Health, Labour and Welfare (“MHLW”) for the treatment of patients with unresectable biliary tract cancer with an FGFR2 fusion gene, worsening after cancer chemotherapy, and was approved by the European Commission for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement that has progressed after at least one prior line of systemic therapy. In July 2021, the UK’s National Institute for Health and Care Excellence (“NICE”) recommended PEMAZYRE for patients with cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy. NICE’s guidance enables all eligible patients in England and Wales to have access to PEMAZYRE through the National Health Service. In March 2022, PEMAZYRE was approved by the National Medical Products Administration of the People’s Republic of China for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement as confirmed by a validated diagnostic test that has progressed after at least one prior line of systemic therapy.
In August 2022, PEMAZYRE was approved by the FDA as the first and only targeted treatment for myeloid/lymphoid neoplasms (“MLNs”) with FGFR1 rearrangement. In March 2023, PEMAZYRE was approved by the MHLW for the treatment of MLNs with FGFR1 fusion.
ICLUSIG (ponatinib)
In June 2016, we acquired the European operations of ARIAD Pharmaceuticals, Inc., and obtained an exclusive license to develop and commercialize ICLUSIG (ponatinib), a kinase inhibitor, in Europe and other select countries. The primary target for ICLUSIG is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (“CML”) and Philadelphia-chromosome positive acute lymphoblastic leukemia (“Ph+ ALL”).
In the European Union, ICLUSIG is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase CML who are resistant to dasatinib or nilotinib, who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Ph+ ALL who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
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ZYNYZ (retifanlimab-dlwr)
In October 2017, we and MacroGenics, Inc. (“MacroGenics”), announced an exclusive global collaboration and license agreement for MacroGenics’ retifanlimab (formerly INCMGA0012), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1). Under this collaboration, we obtained exclusive worldwide rights for the development and commercialization of retifanlimab in all indications.
In March 2023, the FDA approved ZYNYZ (retifanlimab-dlwr) under accelerated approval for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (“MCC”). In April 2024, the European Commission approved ZYNYZ (retifanlimab) as a monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced MCC not amenable to curative surgery or radiation therapy.
In May 2025, the FDA approved ZYNYZ (retifanlimab-dlwr) for the treatment of adult patients with advanced squamous cell anal cancer (“SCAC”) in combination with chemotherapy and as a single agent. We have submitted a Type II variation Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) and a Japanese New Drug Application for retifanlimab in advanced SCAC.
NIKTIMVO (axatilimab-csfr)
In September 2021, we and Syndax Pharmaceuticals, Inc. announced an exclusive worldwide collaboration and license agreement to develop and commercialize axatilimab, Syndax’s anti-CSF-1R monoclonal antibody.
In August 2024, the FDA approved NIKTIMVO (axatilimab-csfr) for the treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients. NIKTIMVO is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD. The U.S. commercial launch of NIKTIMVO commenced in January 2025. Also in January 2025, the FDA approved two smaller vial sizes (9mg and 22mg) of NIKTIMVO to facilitate patient dosing and limit product waste.
Clinical Programs in Hematology and Oncology
Ruxolitinib XR
We are developing a once-a-day formulation of ruxolitinib for potential use as monotherapy and in combinations. Bioavailability and bioequivalence data were published for ruxolitinib’s once-daily (“QD”) extended release (“XR”) formulation at the European Hematology Association (“EHA”) Virtual Congress in June 2021. In March 2023, the FDA issued a complete response letter (“CRL”) for ruxolitinib XR tablets for QD use in the treatment of certain types of MF, PV and GVHD. In December 2023, we received FDA feedback and agreed on the requirements to address the CRL. In early 2025, we announced that a bioequivalence study of ruxolitinib XR was completed and met the bioequivalence criteria set by the FDA. These data are anticipated to be submitted to the FDA, in response to the CRL, by year-end 2025.
INCB57643 (BET inhibitor)
INCB057643 is a small-molecule inhibitor of BET that was being evaluated as monotherapy and in combination with ruxolitinib in patients with advanced malignancies. In October 2025, development for INCB57643 was discontinued.
INCA033989 (mutCALR)
In June 2025, data from our Phase 1 study evaluating INCA033989, an Incyte-discovered, investigational novel anti-mutant calreticulin (“CALR”)-targeted monoclonal antibody, in mutCALR positive patients with essential thrombocythemia were presented during a late-breaking session at the 2025 EHA Congress in Milan, Italy. The data showed rapid and durable normalization of platelet counts across all dose levels and importantly, a reduction in peripheral blood mutCALR variant allele frequency correlating with hematologic response. INCA033989 was well tolerated with a favorable safety profile with no dose limiting toxicities reported. Together, the data demonstrates the potential for INCA033989 to modify disease by directly inhibiting and eliminating oncogenic mutCALR cells, while sparing healthy cells and restoring normal blood cell production. The Phase 1 data in patients with MF as monotherapy and in combination with ruxolitinib are anticipated in the second half of 2025.
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In October 2025, we announced a strategic partnership with Enable Injections, Inc. (“Enable”) to develop and commercialize specific assets in our portfolio, including INCA033989, with Enable’s enFuse ® on-body delivery system. Under the terms of the agreement, we will obtain a worldwide, exclusive license to use the enFuse technology with INCA033989 in essential thrombocythemia and MF, with the potential to expand to additional assets and indications.
Other Clinical Programs
INCB160058 (JAK2V617Fi)
We initiated a Phase 1 study of INCB160058, an Incyte-discovered, investigational novel potent and selective JAK2 pseudokinase domain binder with potential to be a disease modifying therapeutic, in the first quarter of 2024. In preclinical studies, INCB160058 inhibited cytokine independent activity of JAK2V617F while sparing WT JAK2.
Tafasitamab
Tafasitamab is an anti-CD19 antibody and is being investigated as a therapeutic option in B cell malignancies in a number of ongoing and planned combination trials. The open-label Phase 2 combination trial (L-MIND) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with r/r DLBCL and the ongoing Phase 3 B-MIND trial is assessing the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. firstMIND is a Phase 1b safety trial of tafasitamab as a first-line therapy for patients with DLBCL, and frontMIND is an ongoing placebo-controlled Phase 3 trial evaluating tafasitamab in combination with lenalidomide added to rituximab plus chemotherapy as a first-line therapy for patients with DLBCL.
Retifanlimab
We are conducting two Phase 3 clinical studies evaluating retifanlimab, a humanized monoclonal antibody targeting PD-1, in SCAC and non-small cell lung cancer (“NSCLC”). POD1UM-303/InterAACT2 is a Phase 3, global, multicenter, randomized, double-blind study evaluating carboplatin-paclitaxel with retifanlimab or placebo in patients with inoperable locally recurrent or metastatic SCAC who have not previously been treated with chemotherapy. POD1UM-304 is a Phase 3, global, multicenter, randomized, double-blind study evaluating platinum-based chemotherapy with retifanlimab or placebo in patients with first-line, metastatic squamous or nonsquamous NSCLC.
In July 2024, we announced that both trials met their respective primary endpoints. In September 2024, we presented late-breaking Phase 3 results showing that the Phase 3 POD1UM-303/InterAACT2 trial for retifanlimab met the primary endpoint of progression free survival and demonstrated improvement across key secondary endpoints in patients with SCAC receiving retifanlimab in combination with platinum-based chemotherapy (carboplatin-paclitaxel).
INCB123667 (CDK2)
INCB123667 is a novel, potent and selective oral small molecule inhibitor of serine threonine kinase (“CDK2”) which has been shown to suppress tumor growth as monotherapy and in combination with standard of care, in Cyclin E amplified tumor models, in vivo. We are evaluating INCB123667 in a Phase 1 clinical trial in patients with advanced malignancies including CCNE1 high TNBC and HR+HER2- tumors post-CDK4/6 inhibitors.
In September 2024, we presented initial data from the Phase 1 CDK2 inhibitor program at the 2024 European Society of Medical Oncology (“ESMO”) Congress. Phase 1 data of INCB123667 were presented demonstrating single-agent antitumor activity across a range of doses and regimens, notably in patients with ovarian cancer and endometrial cancer whose tumors overexpress Cyclin E1. The Phase 1 trial is ongoing with INCB123667 in combination with other agents. In September 2025, a Phase 2 single-arm study of INCB123667 (CDK2i) in patients with platinum-resistant ovarian cancer (PROC) with Cyclin E1 overexpression was initiated. A Phase 3, randomized, open-label study of INCB123667 versus investigator’s choice chemotherapy in patients with PROC with Cyclin E1 overexpression is planned to initiate by year-end 2025.
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Select Earlier-Stage Development Programs in Hematology and Oncology
INCB161734 (KRAS G12D)
INCB161734 is a potent, selective and orally bioavailable KRAS G12D inhibitor that is currently being evaluated in a Phase 1 study in patients with locally advanced or metastatic solid tumor with KRASG12D mutation. In October 2025, preliminary data from the ongoing Phase 1 study were presented at the 2025 European Society of Medical Oncology (ESMO) Congress. In the study, INCB161734 demonstrated a manageable safety profile and clinical efficacy in heavily pretreated pancreatic ductal adenocarcinoma (PDAC) patients with a KRASG12D mutation. Based upon these results, we intend to continue further development of INCB161734.
INCA33890 (TGFβR2xPD-1)
INCA33890 is a TGFβR2xPD-1 bispecific antibody that has been engineered to avoid the known toxicity of broad TGFβ pathway blockade. INCA33890 has a 10-fold higher binding affinity for PD-1 relative to TGFβR2, and specifically blocks TGFβ signaling in cells co-expressing PD-1. In July 2023, we initiated a Phase 1 study evaluating INCA33890 in patients with select advanced/metastatic solid tumors. In October 2025, data from the ongoing Phase 1 study evaluating were presented at the 2025 ESMO Congress. In the study, INCA33890 demonstrated clinical efficacy across multiple tumors, including microsatellite stable colorectal cancer (MSS CRC) in patients with and without active liver metastases. INCA33890 was generally well tolerated and evaluation of INCA33890 in combination with standard of care (SoC) treatments in patients with metastatic CRC is ongoing. Based on these initial findings, we plan to initiate a registrational program evaluating INCA33890 in MSS CRC in 2026.
Inflammation and AutoImmunity
Incyte Dermatology launched its first approved product, OPZELURA (ruxolitinib) cream, in October 2021. OPZELURA subsequently was approved by the FDA and European Commission for vitiligo in July 2022 and April 2023, respectively. Our IAI efforts also include numerous clinical development programs.
OPZELURA (ruxolitinib) cream
Atopic Dermatitis . In September 2021, the FDA approved OPZELURA (ruxolitinib) cream, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (“AD”) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. AD is a skin disorder that causes long term inflammation of the skin resulting in itchy, red, swollen and cracked skin.
In September 2025, the FDA approved the supplemental New Drug Application (“sNDA”) for OPZELURA for the short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised children two years of age and older whose disease is not well controlled with topical prescription therapies, or when those therapies are not recommended.
Vitiligo. In July 2022, the FDA approved OPZELURA for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. OPZELURA was approved for continuous use and no limits to duration as a treatment for nonsegmental vitiligo. Vitiligo is a chronic autoimmune depigmenting skin disease characterized by patches of the skin losing their pigment. OPZELURA is the first and only FDA approved treatment for repigmentation of vitiligo lesions.
In April 2023, the European Commission approved OPZELURA for the topical treatment of nonsegmental vitiligo with facial involvement in adults and adolescents 12 years and older following a positive opinion from the Committee for Medicinal Products for Human Use (“CHMP”). In October 2024, OPZELURA cream 1.5% was granted a Notice of Compliance by Health Canada for the topical treatment of both mild to moderate AD and nonsegmental vitiligo in patients 12 years of age and older.
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Clinical Programs in Dermatology
Ruxolitinib cream
Ruxolitinib cream is a potent, selective inhibitor of JAK1 and JAK2 that provides the opportunity to directly target diverse pathogenic pathways that underlie certain dermatologic conditions, including pediatric AD, vitiligo, hidradenitis suppurativa (“HS”) and prurigo nodularis (“PN”).
Atopic Dermatitis. In July 2025, we announced positive topline results from the Phase 3 (TRuE-AD4) study evaluating ruxolitinib cream in adult patients with moderate atopic dermatitis. The study met the co-primary endpoints at Week 8, with a statistically significant proportion of patients achieving both Investigator’s Global Assessment Treatment Success and EASI75, which is defined as a 75% or greater improvement in the Eczema Area Severity Index score from baseline. In addition, the study met all key secondary endpoints. Ruxolitinib cream was well tolerated with no new safety signals.
Hidradenitis Suppurativa. In January 2024, we announced positive topline results from a randomized controlled Phase 2 study evaluating ruxolitinib cream in HS. Ruxolitinib 1.5% cream twice daily met the primary efficacy endpoint as measured by a change from baseline in abscess and nodule count at Week 16 versus placebo in patients with mild to moderate HS. Ruxolitinib cream was well tolerated and consistent with its known safety profile. In June 2025, two Phase 3 studies (TRuE-HS2 and TRuE-HS2) evaluating ruxolitinib cream in mild to moderate HS were initiated.
Prurigo Nodularis. In March 2025, results from two Phase 3 studies (TRuE-PN1 and TRuE-PN2) evaluating ruxolitinib cream in patients with PN were presented in a late-breaking oral session at the American Academy of Dermatology annual meeting. The TRuE-PN1 study met the primary endpoint of a > 4-point improvement from baseline in Worst-Itch Numeric Rating Scale at Week 12 and all key secondary endpoints. The TRuE-PN2 study did not reach statistical significance for the primary endpoint, resulting in the key secondary endpoints with nominal p-values. These key secondary endpoints still demonstrate positive trends for ruxolitinib cream 1.5% versus vehicle. These data will inform planned discussions with regulatory authorities on submission.
Povorcitinib
We also are developing povorcitinib, which is an oral small molecule selective JAK1 inhibitor. Povorcitinib is undergoing evaluation in patients with HS, nonsegmental vitiligo, PN, asthma and chronic spontaneous urticaria (“CSU”).
Hidradenitis Suppurativa. HS is a chronic skin condition where lesions develop as a result of inflammation and infection of the sweat glands. In March 2025, positive results from two Phase 3 studies (STOP-HS1 and STOP-HS2) evaluating povorcitinib in patients with HS were presented and demonstrated that both studies met their primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 and at both tested doses (45mg and 75mg). In addition, at Week 12, patients treated with povorcitinib achieved deep levels of clinical response with a greater proportion achieving HiSCR75, reduction in flares, >3-point decrease in the Skin Pain NRS score and Skin Pain NRS30. Furthermore, povorcitinib demonstrated rapid onset of response, including rapid skin pain reduction.
In September 2025, additional data from the STOP-HS1 and STOP-HS2 studies were presented at the European Association of Dermatology and Venereology (EADV) Annual Meeting. In the studies, povorcitinib demonstrated sustained improvements in symptoms for patients with active moderate to severe hidradenitis suppurativa (HS) through 24 weeks. These data support the planned regulatory submissions of povorcitinib for the treatment of HS in 2025 and 2026.
Nonsegmental Vitiligo. In March and October 2023, we presented results from the Phase 2b clinical trial evaluating povorcitinib in patients with extensive nonsegmental vitiligo which demonstrated that treatment with oral povorcitinib was associated with substantial total body and facial repigmentation, as measured by total Vitiligo Area Scoring Index.
Prurigo Nodularis. In October 2023, we announced that the Phase 2, randomized, double-blind, placebo-controlled, dose ranging study evaluating the efficacy and safety of povorcitinib in participants with PN had met its primary endpoint. In October 2024, following the positive Phase 2 results, two Phase 3 studies in patients with PN were initiated.
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Asthma and Chronic Spontaneous Urticaria (CSU). In July 2023, we initiated a Phase 2 trial evaluating povorcitinib in patients with moderate to severe uncontrolled asthma. Data from this proof-of-concept study is anticipated in 2026.
In April 2025, we announced positive topline results from the Phase 2 study evaluating povorcitinib in patients with CSU. The study met the primary endpoint at Week 12 of change from baseline in the Urticaria Activity Score summed over 7 days. Povorcitinib was well tolerated with no new safety signals observed. In October 2025, we decided not to pursue further development of povorcitinib in CSU to prioritize other programs.
Other Clinical Programs
INCA034460 (anti-CD122)
In November 2022, we acquired Villaris Therapeutics, Inc., an asset-centric biopharmaceutical company focused on the development of novel antibody therapeutics for vitiligo. INCA034460 is a novel, humanized anti-IL-15Rβ monoclonal antibody designed to target and deplete autoreactive tissue resident memory T cells that has demonstrated efficacy as a treatment for vitiligo in preclinical model s. In October 2025, we paused further development of INCA034460.
INCB00928 (zilurgisertib)
In May 2022, we initiated a Phase 2 trial evaluating zilurgisertib (INCB00928) in patients with fibrodysplasia ossificans progressiva (“FOP”), a disorder in which muscle tissue and connective tissue are gradually replaced by bone. The FDA has granted Fast Track designation and orphan drug designation to zilurgisertib as a treatment for patients with FOP.
Collaborative Partnered Programs
As described below under “License Agreements and Business Relationships,” we are eligible for milestone payments and royalties on certain products that we licensed to third parties. These include OLUMIANT (baricitinib), which is licensed to our collaborative partner Eli Lilly and Company (“Lilly”), and JAKAVI (ruxolitinib) and TABRECTA (capmatinib), which are licensed to Novartis.
Baricitinib
We have a second JAK1 and JAK2 inhibitor, baricitinib, which is subject to our collaboration agreement with Lilly, in which Lilly received exclusive worldwide development and commercialization rights to the compound for inflammatory and autoimmune diseases.
Rheumatoid Arthritis. In February 2017, the European Commission approved baricitinib as OLUMIANT for the treatment of moderate-to-severe rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs. In July 2017, the MHLW granted marketing approval for OLUMIANT for the treatment of rheumatoid arthritis (including the prevention of structural injury of joints) in patients with inadequate response to standard-of-care therapies. In June 2018, the FDA approved the 2mg dose of OLUMIANT for the treatment of adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies.
Atopic Dermatitis. Lilly has conducted a Phase 2a trial and a Phase 3 program to evaluate the safety and efficacy of baricitinib in patients with moderate-to-severe AD. In October 2020, the European Commission approved baricitinib as OLUMIANT for the treatment of moderate-to-severe AD in adult patients who are candidates for systemic therapy. In December 2020, baricitinib was approved by the MHLW for the treatment of patients with moderate-to-severe AD.
Alopecia Areata . In June 2022, the FDA approved 2mg, and 4mg doses of OLUMIANT for the treatment of adults with severe alopecia areata, an autoimmune disorder in which the immune system attacks the hair follicles causing hair loss in patches, becoming the first and only systemic treatment in the indication. In June 2022, OLUMIANT was approved as a treatment for alopecia areata in Europe and Japan.
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COVID-19. In May 2020, we amended our agreement with Lilly to enable Lilly to commercialize baricitinib for the treatment of COVID-19. The FDA’s Emergence Use Authorization provides for the use of baricitinib for the treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (“ECMO”). In June 2022, the FDA approved baricitinib as OLUMIANT for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or ECMO.
Type 1 Diabetes . In October 2025, we amended our agreement with Lilly to enable Lilly to commercialize baricitinib for the treatment of Type 1 diabetes mellitus.
Capmatinib
Capmatinib is a potent and highly selective mesenchymal-epithelial-transition factor gene (“MET”) inhibitor. The investigational compound has demonstrated inhibitory activity in cell-based biochemical and functional assays that measure MET signaling and MET dependent cell proliferation, survival and migration. Under our agreement, Novartis received worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications. Capmatinib is being evaluated in patients with hepatocellular carcinoma, NSCLC and other solid tumors, and may have potential utility as a combination agent.
In May 2020, the FDA approved capmatinib as TABRECTA for the treatment of adult patients with metastatic NSCLC whose tumors have a mutation that leads to MET exon 14 (“METex14”) skipping as detected by an FDA-approved test. TABRECTA is the first and only treatment approved to specifically target NSCLC with this driver mutation and is approved for first-line and previously treated patients regardless of prior treatment type.
In June 2020, the MHLW approved TABRECTA for METex14 mutation-positive advanced and/or recurrent unresectable NSCLC. In April 2022, we and Novartis announced a positive opinion from the CHMP based on data from the Phase 2 GEOMETRY mono-1 study. In June 2022, the European Commission approved capmatinib as TABRECTA as a monotherapy treatment of adults with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
Ruxolitinib
Graft-versus-host disease. In March 2022, we and Novartis announced a positive opinion from the CHMP for ruxolitinib in acute and chronic GVHD, based on data from the Phase 3 REACH2 and REACH3 trials. In May 2022, the European Commission approved ruxolitinib as JAKAVI for the treatment of acute or chronic GVHD in patients aged 12 years and older who have inadequate response to corticosteroids or other systemic therapies. In August 2023, Novartis announced that JAKAVI had been approved in Japan for use in GVHD after hematopoietic stem cell transplant.
License Agreements and Business Relationships
We establish business relationships, including collaborative arrangements with other companies and medical research institutions to assist in the clinical development and/or commercialization of certain of our drugs and drug candidates and to provide support for our research programs. We also evaluate opportunities for acquiring products or rights to products and technologies that are complementary to our business from other companies and medical research institutions.
Below is a brief description of our significant business relationships and collaborations and related license agreements that expand our pipeline and provide us with certain rights to existing and potential new products and technologies. Additional information regarding our collaboration agreements, including their financial and accounting impact on our business and results of operations, can be found in Note 6 and Note 8 of Notes to the Condensed Consolidated Financial Statements.
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Out-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 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. We retained options to co-develop and to co-promote capmatinib in the United States. In April 2016, we amended this agreement to provide that Novartis has exclusive research, development and commercialization rights outside of the United States to ruxolitinib (excluding topical formulations) in the GVHD field.
Lilly
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 baricitinib and certain back up compounds for inflammatory and autoimmune diseases. In March 2016, we entered into an amendment to the agreement with Lilly that allows us to engage in the development and commercialization of ruxolitinib in the GVHD field. In May 2020, we amended our agreement with Lilly to enable Lilly to commercialize baricitinib for the treatment of COVID-19 and in October 2025, we further amended the agreement to enable Lilly to commercialize baricitinib for the treatment of Type 1 diabetes mellitus. We will receive an upfront payment of $100.0 million in connection with the 2025 amendment, which amendment also restructured the royalty obligations on net sales of baricitinib, certain developmental and regulatory milestones associated with baricitinib, and the marketing and sales support obligations of Lilly. On baricitinib sales for any indication, we are now eligible to receive either a fixed royalty amount or tiered royalties based on a defined level of quarterly global net sales, with the tiered royalties up to a rate in the mid-teens. Additionally, for the treatment of COVID-19, we still receive a premium on royalties.
In-License Agreements
MacroGenics
In October 2017, we entered into a Global Collaboration and License Agreement with MacroGenics. Under this agreement, we received exclusive development and commercialization rights worldwide to MacroGenics’ INCMGA0012, an investigational monoclonal antibody that inhibits PD-1. MacroGenics has retained the right to develop and commercialize, at its cost and expense, its pipeline assets in combination with INCMGA0012.
Merus
In December 2016, we entered into a Collaboration and License Agreement with Merus. Under this agreement, which became effective in January 2017, 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.
Syndax
In September 2021, we entered into a Collaboration and License Agreement with Syndax covering the worldwide development and commercialization of NIKTIMVO (axatilimab-csfr), Syndax’s anti-CSF-1R monoclonal antibody. Under the terms of this agreement, we received exclusive commercialization rights to axatilimab outside of the United States, and co-commercialization rights in the United States.
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