6 unchanged sentences
Securities and Exchange Commission's rules and forms;
+Added: Table o f Contents
(b) such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
−Removed: T able of Contents
In designing and evaluating our disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
14 unchanged sentences
Based on our assessment, our management has concluded that, as of December 31, 2024, our internal control over financial reporting is effective based on those criteria.
−Removed: We excluded Reata from our assessment of internal control over financial reporting as of December 31, 2023, as Reata was acquired by our Company in a business combination during 2023.
−Removed: The total assets and total revenue of Reata represents 1.0% and 0.6%, respectively, of the related consolidated financial statement amounts as of and for the year ended December 31, 2023.
The effectiveness of our internal control over financial reporting as of December 31, 2024, has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their attestation report, which is included herein.
6 unchanged sentences
10b5-1 Non-Rule 10b5-1 Total Shares to be Sold Expiration Date
−Removed: Robin Kramer ( Senior Vice President, Chief Accounting Officer )
+Added: Sherwin , Director
Adopt 11/7/2024 X — 8,760 05/08/2025
−Removed: T able of Contents
+Added: Table o f Contents
DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not Applicable.
−Removed: T able of Contents
+Added: Table o f Contents
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information concerning our executive officers is set forth under the heading Information about our Executive Officers in Item 1 of this report.
+Added: Code of Business Conduct and Ethics:
The text of our code of business conduct, which includes the code of ethics that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, and persons performing similar functions, is posted on our website, www.biogen.com, under the “ Corporate Governance ” subsection of the “ Investors ” section of the site.
We intend to make all required disclosures regarding any amendments to, or waivers from, provisions of our code of business conduct at the same location of our website.
+Added: Insider Trading Policy:
+Added: We have adopted an insider trading policy governing the purchase, sale and/or other dispositions of our securities and those of public companies in which we do business with by our directors, executive officers, employees and temporary staff, that we believe is reasonably designed to promote compliance with insider trading laws, rules and regulations and applicable NASDAQ listing standards.
+Added: A copy of our insider trading policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K.
The response to the remainder of this item is incorporated by reference from the discussion responsive thereto in the sections entitled “ Proposal 1 - Election of Directors,” “Corporate Governance” and “ Miscellaneous - Stockholder Proposals ” contained in the proxy statement for our 2025 annual meeting of stockholders.
7 unchanged sentences
The response to this item is incorporated by reference from the discussion responsive thereto in the section entitled “ Proposal 2 - Ratification of the Selection of our Independent Registered Public Accounting Firm ” contained in the proxy statement for our 2025 annual meeting of stockholders.
−Removed: T able of Contents
+Added: Table o f Contents
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
15 unchanged sentences
Not applicable.
−Removed: T able of Contents
+Added: Table o f Contents
EXHIBIT INDEX
9 unchanged sentences
Filed as Exhibit 3.1 to our Current Report on Form 8-K filed on June 8, 2021.
−Removed: 3.4 Fifth Amended and Restated Bylaws.
+Added: 3.4 Certificate of Amendment of Biogen Inc.'s Amended and Restated Certificate of Incorporation, as amended.
+Added: Filed as Exhibit 3.1 to our Current Report on Form 8-K filed on June 25, 2024.
+Added: 3.5 Fifth Amended and Restated Bylaws of Biogen Inc.
Filed as Exhibit 3.1 to our Current Report on Form 8-K filed on December 12, 2023.
13 unchanged sentences
4.6+ Description of Securities.
−Removed: Credit Agreement, dated as of January 28, 2020, among Biogen Inc., Bank of America, N.A., as administrative agent, swing line lender and the L/C issuer, and the other lenders party thereto.
−Removed: Filed as Exhibit 10.1 to our Current Report on Form 8-K filed on February 3, 2020.
−Removed: Amendment to Credit Agreement, dated as of February 7, 2023, by and among Biogen Inc., Bank of America, N.A., as administrative agent, swing line lender and the L&C issuer, and the other lenders party thereto.
Filed as Exhibit 4.6 to our Annual Report on Form 10-K for the year ended December 31, 202 3.
+Added: 10.1 Credit Agreement, dated as of August 12, 2024, among Biogen Inc., Bank of America, N.A., as administrative agent, swing line lender and the L/C issuer, and the other lenders party thereto.
+Added: Filed as Exhibit 10.1 to our Current Report on Form 8-K filed on August 14, 2024.
10.2 Credit Agreement, dated as of August 28, 2023, among Biogen Inc., JPMorgan Chase Bank N.S., as administrative agent and the other lenders party thereto.
6 unchanged sentences
Filed as Exhibit 10.6 to our Annual Report on Form 10-K for the year ended December 31, 2010.
−Removed: 2017 Omnibus Equity Plan.
−Removed: Filed as Appendix B to our Definitive Proxy Statement on Schedule 14A filed on April 26, 2017.
−Removed: Form of restricted stock unit award agreement under the Biogen Inc.
−Removed: 2017 Omnibus Equity Plan.
−Removed: Filed as Exhibit 10.2 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017.
−Removed: Form of market stock unit award agreement under the Biogen Inc.
−Removed: 2017 Omnibus Equity Plan.
+Added: 10.5 Form of performance share award agreement under the Biogen Inc.
+Added: 2024 Omnibus Equity P lan.
Filed as Exhibit 10.3 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 202 4.
−Removed: Form of performance unit award agreement under the Biogen Inc.
+Added: 10.6 Form of restricted stock award agreement under the Biogen Inc.
2024 Omnibus Equity Plan.
Filed as Exhibit 10.4 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024.
−Removed: Form of cash-settled performance unit award agreement under the Biogen Inc.
−Removed: 2017 Omnibus Equity Plan.
+Added: 10.7 F orm of non-employee dire ctor restricted stock u ni t awar d agreement under the Biogen Inc.
+Added: 2024 Omni bus Equity Plan.
Filed as Exhibit 10.5 to our Quarterly Report on Form 10- Q for the quarter ended June 30, 2024.
−Removed: Form of performance stock units award agreement (cash-settled) under the Biogen Inc.
−Removed: 2017 Omnibus Equity Plan.
−Removed: Filed as Exhibit 10.10 to our Annual Report on Form 10-K for the year ended December 31, 2017.
−Removed: Form of performance stock units award agreement under the Biogen Inc.
−Removed: 2017 Omnibus Equity Plan.
−Removed: Filed as Exhibit 10.11 to our Annual Report on Form 10-K for the year ended December 31, 2017.
−Removed: Form of performance stock units award agreement under the Biogen Inc.
+Added: 10.8* Biogen Inc.
2017 Omnibus Equity Plan.
−Removed: Filed as Exhibit 10.1 to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2018.
−Removed: Form of performance stock units award agreement (cash settled) under the Biogen Inc.
+Added: Filed as Appendix B to our Definitive Proxy Statement on Schedule 14A filed on April 26, 2017.
+Added: 10.9* Form of restricted stock unit award agreement under the Biogen Inc.
2017 Omnibus Equity Plan.
−Removed: Filed as Exhibit 10.2 to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2018.
−Removed: Form of market stock unit award agreement under the Biogen Inc.
−Removed: 2017 Omnibus Equity Plan (for grants commencing in July 2019).
Filed as Exhibit 10.2 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017.
2 unchanged sentences
Filed as Exhibit 10.2 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2019.
−Removed: T able of Contents
−Removed: Form of performance stock units award agreement (cash settled) under the Biogen Inc.
−Removed: 2017 Omnibus Equity Plan (for grants commencing in July 2019).
−Removed: Filed as Exhibit 10.3 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2019.
10.11* Form of nonqualified stock option award agreement under Biogen Inc.
1 unchanged sentence
Filed as Exhibit 10.20 to our Annual Report on Form 10-K for the year ended December 31, 2022.
−Removed: 2006 Non-Employee Directors Equity Plan, as amended.
−Removed: Filed as Exhibit 10.2 to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022.
−Removed: 2015 Employee Stock Purchase Plan.
−Removed: Filed as Appendix A to our Definitive Proxy Statement on Schedule 14A filed on April 30, 2015.
10.12* Biogen Idec Inc.
1 unchanged sentence
Filed as Appendix B to our Definitive Proxy Statement on Schedule 14A filed on May 8, 2008.
+Added: 10.13* Biogen Inc.
2019 Form of Performance-Based Management Incentive Plan, as amended.
Filed as Exhibit 10.1 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021.
−Removed: Biogen Idec Inc.
−Removed: Voluntary Executive Supplemental Savings Plan, as amended and restated effective January 1, 2004.
−Removed: Filed as Exhibit 10.13 to our Annual Report on Form 10-K for the year ended December 31, 2003.
−Removed: Biogen Idec Inc.
−Removed: Supplemental Savings Plan, as amended.
−Removed: Filed as Exhibit 10.23 to our Annual Report on Form 10-K for the year ended December 31, 2015.
−Removed: Biogen Idec Inc.
−Removed: Voluntary Board of Directors Savings Plan, as amended.
−Removed: Filed as Exhibit 10.24 to our Annual Report on Form 10-K for the year ended December 31, 2015.
+Added: 10.14+ Voluntary Board of Directors Savings Plan.
+Added: 10.15+ Biogen Inc.
+Added: Supplemental Savings Plan.
+Added: 10.16* Biogen Inc.
Executive Severance Policy - U.S.
1 unchanged sentence
Filed as Exhibit 10.1 to our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020.
+Added: Table o f Contents
10.17* Annual Retainer Summary for Board of Directors (effective January 1, 2020).
9 unchanged sentences
Filed as Exhibit 10.58 to our Annual Report on Form 10-K for the year ended December 31, 2009.
−Removed: L etter amending employment arrangement of Susan Alexander dated February 28, 2020.
−Removed: L etter regarding employment arrangement of Rachid Izzar dated August 1, 2019.
−Removed: L etter regarding employment arrangement of Nicole Murphy dated January 28, 2022.
−Removed: Filed as Exhi bit 10.
−Removed: 3 to our Q uarterly Report on Form 10-Q for the quarter ended Mar ch 31, 20 2 3 .
−Removed: J VA Termination Agreement , by and among Biogen Therap eutics Inc.
−Removed: , Samsung BioLogics Co., Ltd.
−Removed: and Samsung Bioepis Co., Ltd, dated April 20, 2020.
+Added: 10.22* Letter amending employment arrangement of Susan Alexander dated February 28, 2020.
+Added: Filed as Exhibit 10.32 to our Annual Report on Form 10-K for the year ended December 3 1, 202 3.
+Added: 10.23* Letter regarding employment arrangement of Rachid Izzar dated August 1, 2019.
+Added: Filed as Exhibit 10.33 to our Annual Report on Form 10-K for the year ended December 31, 2023.
+Added: 10.24* Letter regarding employment arrangement of Nicole Murphy dated January 28, 2022.
+Added: Filed as Exhibit 10.3 to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023.
+Added: 10.25* L etter regarding employment arrangement of Robi n Kramer dated October 28, 2024.
+Added: Fil ed as Exhi b i t 10.1 to our Current Report on Form 8-K filed on October 30, 2024.
10.26 Amended and Restated Collaboration Agreement, dated October 22, 2017, between Biogen MA Inc.
4 unchanged sentences
Filed as Exhibit 10.46 to our Annual Report on Form 10-K for the year ended December 31, 2022.
+Added: 19.1+ Policy relating to insider trading.
21+ Subsidiaries.
4 unchanged sentences
Policy relating to recovery of erroneously awarded compensation.
+Added: Filed as Exhibit 97.1 to our Annual Report on Form 10-K for the year ended December 31, 2023.
101++ The following materials from Biogen Inc.’s Annual Report on Form 10-K for the year ended December 31, 2024, formatted in iXBRL (Inline Extensible Business Reporting Language):
(i) the Consolidated Statements of Income, (ii) the Consolidated Statements of Comprehensive Income, (iii) the Consolidated Balance Sheets, (iv) the Consolidated Statements of Cash Flow, (v) the Consolidated Statements of Equity and (vi) Notes to Consolidated Financial Statements.
+Added: 104 Cover Page Interactive Data File (contained in Exhibit 101)
* Management contract or compensatory plan or arrangement.
2 unchanged sentences
++ Furnished herewith.
−Removed: T able of Contents
+Added: Table o f Contents
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
−Removed: / S / C HRISTOPHER A.
+Added: /S/ CHRISTOPHER A.
Christopher A.
1 unchanged sentence
February 12, 2025
−Removed: T able of Contents
+Added: Table o f Contents
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Name Capacity Date
−Removed: / S / C HRISTOPHER A.
+Added: /S/ CHRISTOPHER A.
Director and Chief Executive Officer (principal executive officer) February 12, 2025
Christopher A.
−Removed: / S / M ICHAEL R.
+Added: /S/ MICHAEL R.
Executive Vice President and Chief Financial Officer (principal financial officer) February 12, 2025
−Removed: / S / R OBIN C.
Senior Vice President, Chief Accounting Officer (principal accounting officer) February 12, 2025
−Removed: / S / C AROLINE D.
+Added: /S/ CAROLINE D.
Director and Chair of the Board of Directors February 12, 2025
−Removed: / S / M ARIA C.
Director February 12, 2025
−Removed: / S / W ILLIAM A.
+Added: /S/ WILLIAM A.
Director February 12, 2025
−Removed: / S / S USAN L ANGER
+Added: /S/ SUSAN LANGER
Director February 12, 2025
−Removed: / S / J ESUS B.
Director February 12, 2025
−Removed: / S / M ONISH P ATOLAWALA
+Added: MINOR Director February 12, 2025
+Added: /S/ SIR MENELAS PANGALOS Director February 12, 2025
+Added: Sir Menelas Pangalos
+Added: /S/ MONISH PATOLAWALA
Director February 12, 2025
Monish Patolawala
−Removed: / S / E RIC K.
Director February 12, 2025
−Removed: / S / S TEPHEN A.
+Added: /S/ STEPHEN A.
Director February 12, 2025
−Removed: T able of Contents
+Added: Table o f Contents
AND SUBSIDIARIES
7 unchanged sentences
Report of Independent Registered Public Accounting Firm (PCAOB ID 238) F-81
−Removed: T able of Contents
+Added: Table o f Contents
AND SUBSIDIARIES
6 unchanged sentences
Revenue from anti-CD20 therapeutic programs 1,749.9 1,689.6 1,700.5
+Added: Alzheimer's collaboration revenue 59.9 — —
Contract manufacturing, royalty and other revenue 652.6 899.3 485.1
7 unchanged sentences
(Gain) loss on fair value remeasurement of contingent consideration 27.7 — ( 209.1 )
−Removed: Acquired in-process research and development — — 18.0
Restructuring charges 30.2 218.8 131.1
−Removed: Gain on sale of building — ( 503.7 ) —
+Added: Gain on sale of priority review voucher, net ( 88.6 ) — —
+Added: Gain on sale of building, net — — ( 503.7 )
Other (income) expense, net 343.6 315.5 ( 108.2 )
Total cost and expense 7,769.9 8,538.8 6,581.6
−Removed: Income before income tax (benefit) expense and equity in loss of investee, net of tax 1,296.8 3,591.8 1,745.2
+Added: Income before income tax (benefit) expense and equity in (income) loss of investee, net of tax 1,906.0 1,296.8 3,591.8
Income tax (benefit) expense 273.8 135.3 632.8
15 unchanged sentences
See accompanying notes to these consolidated financial statements.
−Removed: T able of Contents
+Added: Table o f Contents
AND SUBSIDIARIES
5 unchanged sentences
$ 1,632.2 $ 1,161.1 $ 3,046.9
−Removed: Other comprehensive income:
+Added: Other comprehensive income (loss):
Unrealized gains (losses) on securities available for sale, net of tax — 15.7 ( 13.5 )
2 unchanged sentences
Unrealized gains (losses) on pension benefit obligation, net of tax ( 14.0 ) ( 1.5 ) 43.7
−Removed: Currency translation adjustment 37.1 ( 24.2 ) ( 92.4 )
+Added: Currency translation adjustments, net of tax ( 45.1 ) 37.1 ( 24.2 )
Total other comprehensive income (loss), net of tax 17.5 11.2 ( 58.2 )
4 unchanged sentences
See accompanying notes to these consolidated financial statements.
−Removed: T able of Contents
+Added: Table o f Contents
AND SUBSIDIARIES
4 unchanged sentences
Cash and cash equivalents $ 2,375.0 $ 1,049.9
−Removed: Marketable securities — 1,473.5
Accounts receivable, net of allowance for doubtful accounts of $ 2.2 and $ 2.4 , respectively
4 unchanged sentences
Total current assets 7,456.8 6,859.3
−Removed: Marketable securities — 705.7
Property, plant and equipment, net 3,181.3 3,309.7
7 unchanged sentences
Current liabilities:
−Removed: Current portion of term loan $ 150.0 $ —
+Added: Current portion of notes payable and term loan $ 1,748.6 $ 150.0
Taxes payable 548.3 257.4
17 unchanged sentences
( 2,977.1 ) ( 2,977.1 )
−Removed: Total Biogen Inc.
−Removed: shareholders’ equity 14,799.4 13,397.9
−Removed: Noncontrolling interests — ( 9.5 )
Total equity 16,716.0 14,799.4
1 unchanged sentence
See accompanying notes to these consolidated financial statements.
−Removed: T able of Contents
+Added: Table o f Contents
AND SUBSIDIARIES
9 unchanged sentences
Excess and obsolescence charges related to inventory 101.9 124.4 336.2
−Removed: Amortization of inventory step-up 31.5 — —
−Removed: Acquired in-process research and development — — 18.0
+Added: Amortization of acquired inventory step-up 230.0 31.5 —
Share-based compensation 291.2 264.2 254.1
4 unchanged sentences
Gain on sale of equity interest in Samsung Bioepis — — ( 1,505.4 )
−Removed: Gain on sale of building — ( 503.7 ) —
+Added: Gain on sale of building, net — — ( 503.7 )
+Added: Gain on sale of priority review voucher, net ( 88.6 ) — —
Other 159.6 148.2 208.2
12 unchanged sentences
Acquisition of Reata, net of cash acquired — ( 6,926.1 ) —
+Added: Acquisition of HI-Bio, net of cash acquired ( 1,074.8 ) — —
Proceeds from sale of equity interest in Samsung Bioepis 406.8 788.1 990.3
Proceeds from sale of building — — 582.6
−Removed: Proceeds from divestiture of Hillerød, Denmark manufacturing operations — — 28.1
−Removed: Acquired in-process research and development — — ( 18.0 )
+Added: Proceeds from sale of priority review voucher, net 88.6 — —
Acquisitions of intangible assets ( 206.1 ) ( 34.4 ) ( 2.9 )
15 unchanged sentences
See accompanying notes to these consolidated financial statements.
−Removed: T able of Contents
+Added: Table o f Contents
AND SUBSIDIARIES
1 unchanged sentence
(In millions)
+Added: For the Year Ended December 31, 2024
Preferred stock Common stock Additional
1 unchanged sentence
comprehensive
−Removed: income (loss)
+Added: income (loss) Retained
earnings Treasury stock Total
−Removed: shareholders’
−Removed: equity Noncontrolling
−Removed: interests Total
Shares Amount Shares Amount Shares Amount
2 unchanged sentences
Other comprehensive income (loss), net of tax — — — — — 17.5 — — — 17.5
−Removed: Capital contribution from noncontrolling interest — — — — — — — — — — 12.3 12.3
−Removed: Deconsolidation of noncontrolling interest — — — — — — — — — — ( 3.2 ) ( 3.2 )
Issuance of common stock under stock option and stock purchase plans — — 0.2 — 36.3 — — — — 36.3
Issuance of common stock under stock award plan — — 0.6 — ( 67.7 ) — — — — ( 67.7 )
−Removed: Compensation expense related to share-based payments — — — — 274.4 — — — — 274.4 — 274.4
+Added: Compensation related to share-based payments — — — — 301.5 — — — — 301.5
Other — — — — ( 3.2 ) — — — — ( 3.2 )
Balance, December 31, 2024 — $ — 169.5 $ 0.1 $ 569.4 $ ( 136.2 ) $ 19,259.8 ( 23.8 ) $ ( 2,977.1 ) $ 16,716.0
−Removed: See accompanying notes to these consolidated financial statements.
−Removed: T able of Contents
−Removed: AND SUBSIDIARIES
−Removed: CONSOLIDATED STATEMENTS OF EQUITY - (Continued)
−Removed: (In millions)
+Added: For the Year Ended December 31, 2023
Preferred stock Common stock Additional
11 unchanged sentences
Capital contribution from noncontrolling interest — — — — — — — — — — 12.3 12.3
−Removed: Repurchase of common stock pursuant to the 2020 Share Repurchase Program, at cost — — — — — — — ( 3.6 ) ( 750.0 ) ( 750.0 ) — ( 750.0 )
−Removed: Retirement of common stock pursuant to the 2020 Share Repurchase Program, at cost — — ( 3.6 ) — ( 257.9 ) — ( 492.1 ) 3.6 750.0 — — —
+Added: Deconsolidation of noncontrolling interest — — — — — — — — — — ( 3.2 ) ( 3.2 )
Issuance of common stock under stock option and stock purchase plans — — 0.2 — 45.1 — — — — 45.1 — 45.1
Issuance of common stock under stock award plan — — 0.6 — ( 89.5 ) — — — — ( 89.5 ) — ( 89.5 )
−Removed: Compensation expense related to share-based payments — — — — 263.5 — — — — 263.5 — 263.5
+Added: Compensation related to share-based payments — — — — 274.4 — — — — 274.4 — 274.4
Other — — — — ( 0.8 ) — — — — ( 0.8 ) — ( 0.8 )
1 unchanged sentence
See accompanying notes to these consolidated financial statements.
−Removed: T able of Contents
+Added: Table o f Contents
AND SUBSIDIARIES
1 unchanged sentence
(In millions)
+Added: For the Year Ended December 31, 2022
Preferred stock Common stock Additional
10 unchanged sentences
Other comprehensive income (loss), net of tax — — — — — ( 58.2 ) — — — ( 58.2 ) — ( 58.2 )
−Removed: Distribution to noncontrolling interest — — — — — — — — — — ( 100.0 ) ( 100.0 )
Capital contribution from noncontrolling interest — — — — — — — — — — 12.3 12.3
3 unchanged sentences
Issuance of common stock under stock award plan — — 0.5 — ( 46.0 ) — — — — ( 46.0 ) — ( 46.0 )
−Removed: Compensation expense related to share-based payments — — — — 246.6 — — — — 246.6 — 246.6
+Added: Compensation related to share-based payments — — — — 263.5 — — — — 263.5 — 263.5
Other — — — — 1.3 — — — — 1.3 — 1.3
7 unchanged sentences
Business Overview
−Removed: Biogen is a global biopharmaceutical company focused on discovering, developing and delivering innovative therapies for people living with serious and complex diseases worldwide.
+Added: Biogen is a global biopharmaceutical company focused on discovering, developing and delivering innovative therapies for people living with serious and complex diseases.
We have a broad portfolio of medicines to treat MS, have introduced the first approved treatment for SMA, co-developed treatments to address a defining pathology of Alzheimer’s disease and launched the first approved treatment to target a genetic cause of ALS.
−Removed: Through our 2023 acquisition of Reata we market the first and only drug approved in the U.S.
−Removed: for the treatment of Friedreich's Ataxia in adults and adolescents aged 16 years and older.
+Added: We market the first and only drug approved in the U.S.
+Added: for the treatment of FA in adults and adolescents aged 16 years and older.
We are focused on advancing our pipeline in neurology, specialized immunology and rare diseases.
−Removed: We support our drug discovery and development efforts through internal research and development programs and external collaborations.
−Removed: Our marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA for the treatment of MS;
+Added: We support our drug discovery and development efforts through internal research and development programs, external collaborations and acquisitions.
+Added: Our marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY and TYSABRI for the treatment of MS;
SPINRAZA for the treatment of SMA;
−Removed: SKYCLARYS for the treatment of Friedreich's Ataxia;
+Added: SKYCLARYS for the treatment of FA;
QALSODY for the treatment of ALS;
and FUMADERM for the treatment of severe plaque psoriasis.
−Removed: We also have collaborations with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease and Sage on the commercialization of ZURZUVAE for the treatment of PPD and we have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, CLL and other conditions;
+Added: We also have collaborations with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease and Sage on the commercialization of ZURZUVAE for the treatment of PPD.
+Added: We have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, CLL and other conditions;
RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL;
4 unchanged sentences
and have the option to add other potential anti-CD20 therapies, pursuant to our collaboration arrangements with Genentech, a wholly-owned member of the Roche Group.
−Removed: We commercialize a portfolio of biosimilars of advanced biologics including BENEPALI, an etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab biosimilar referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE, in certain countries in Europe, as well as BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, in the U.S.
+Added: We commercialize a portfolio of biosimilars of advanced biologics including:
+Added: BENEPALI, an etanercept biosimilar referencing ENBREL;
+Added: IMRALDI, an adalimumab biosimilar referencing HUMIRA;
+Added: FLIXABI, an infliximab biosimilar referencing REMICADE;
+Added: and BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, in certain international markets, as well as TOFIDENCE, a tocilizumab biosimilar referencing ACTEMRA, in the U.S.
and certain international markets.
−Removed: We also have exclusive rights to commercialize TOFIDENCE, a tocilizumab biosimilar referencing ACTEMRA.
−Removed: We continue to develop potential biosimilar product SB15, a proposed aflibercept biosimilar referencing EYLEA.
−Removed: For additional information on our collaboration arrangements, please read Note 19, Collaborative and Other Relationships , to our consolidated financial statements included in this report.
+Added: We also have commercialization rights related to OPUVIZ, an aflibercept biosimilar referencing EYLEA.
+Added: On July 2, 2024, we completed the acquisition of HI-Bio.
+Added: As a result of this transaction we acquired HI-Bio's lead asset, felzartamab, an anti-CD38 antibody currently being evaluated for three leading indications, AMR, PMN and IgAN.
+Added: For additional information on our acquisition of HI-Bio, please read Note 2, Acquisitions , to these consolidated financial statements.
+Added: For additional information on our collaboration arrangements, please read Note 19, Collaborative and Other Relationships , to these consolidated financial statements.
Consolidation
5 unchanged sentences
In November 2023 we terminated the Neurimmune Agreement, which resulted in the deconsolidation of our variable interest entity, Neurimmune.
−Removed: Use of Estimates
−Removed: The preparation of our consolidated financial statements requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenue and expense and related
AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: disclosure of contingent assets and liabilities.
+Added: Use of Estimates
+Added: The preparation of our consolidated financial statements requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenue and expense and related disclosure of contingent assets and liabilities.
On an ongoing basis we evaluate our estimates, judgments and assumptions.
26 unchanged sentences
If actual results vary, we adjust these estimates, which could have an effect on earnings in the period of adjustment.
−Removed: Discounts include trade term discounts and wholesaler incentives.
+Added: Discounts include trade term discounts, wholesaler incentives and volume related discounts.
Trade term discounts and wholesaler incentives primarily relate to estimated obligations for credits to be granted to wholesalers for remitting payment on their purchases within established incentive periods and credits to be granted to wholesalers for compliance with various contractually-defined inventory management practices, respectively.
We determine these reserves based on our historical experience, including the timing of customer payments.
+Added: Volume related discounts primarily relate to incentives offered to downstream customers who earn discounts based upon the quarterly or annual volume of units purchased.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Contractual adjustments primarily relate to Medicaid and managed care rebates in the U.S., pharmacy rebates, co-payment (copay) assistance, VA and PHS discounts, specialty pharmacy program fees and other governmental rebates or applicable allowances.
2 unchanged sentences
Rebate accruals are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a liability which is included in accrued expense and other current liabilities in our consolidated balance sheets.
−Removed: Our liability for Medicaid rebates consists of estimates for claims
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: that a state will make for the current quarter, claims for prior quarters that have been estimated for which an invoice has not been received, invoices received for claims from the prior quarters that have not been paid and an estimate of potential claims that will be made for inventory that exists in the distribution channel at period end.
+Added: Our liability for Medicaid rebates consists of estimates for claims that a state will make for the current quarter, claims for prior quarters that have been estimated for which an invoice has not been received, invoices received for claims from the prior quarters that have not been paid and an estimate of potential claims that will be made for inventory that exists in the distribution channel at period end.
• Governmental rebates:
25 unchanged sentences
In addition to discounts, rebates and product returns, we also maintain certain customer service contracts with distributors and other customers in the distribution channel that provide us with inventory management, data and distribution services, which are generally reflected as a reduction of revenue.
−Removed: To the extent we can demonstrate a separable benefit and fair value for these services we classify these payments in selling, general and administrative expense in our consolidated statements of income.
+Added: To the extent we can demonstrate a
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: separable benefit and fair value for these services we classify these payments in selling, general and administrative expense in our consolidated statements of income.
Revenue from Anti-CD20 Therapeutic Programs
1 unchanged sentence
For purposes of this footnote, we refer to RITUXAN and RITUXAN HYCELA collectively as RITUXAN.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Our share of the pre-tax co-promotion profits on RITUXAN, GAZYVA and LUNSUMIO and royalty revenue on sales of OCREVUS, resulted from an exchange of a license.
18 unchanged sentences
For additional information on our relationship with Genentech, please read Note 19, Collaborative and Other Relationships, to these consolidated financial statements.
+Added: Alzheimer's Collaboration Revenue
+Added: Alzheimer's collaboration revenue consists of our 50.0 % share of LEQEMBI product revenue, net and cost of sales, including royalties, as we are not the principal.
+Added: We began recognizing Alzheimer's collaboration revenue upon the accelerated approval of LEQEMBI in the U.S.
+Added: during the first quarter of 2023.
Contract Manufacturing, Royalty and Other Revenue
2 unchanged sentences
Revenue under contract manufacturing agreements is recognized when the customer obtains control of the product, which may occur at a point in time or over time depending on the terms and conditions of the agreement.
−Removed: During the first quarter of 2023 we began recognizing contract manufacturing revenue for LEQEMBI, upon accelerated approval of LEQEMBI in the U.S.
−Removed: Prior to accelerated approval, our share of contract manufacturing amounts related to LEQEMBI were recognized in research and development expense within our consolidated statements of income.
−Removed: Royalty and Other Revenue
−Removed: Royalty and other revenue primarily reflects the royalties we receive from net sales on products related to patents that we have out-licensed, as well as royalty revenue on biosimilar products from our collaboration arrangements with Samsung Bioepis and our 50.0 % share of LEQEMBI product revenue, net and cost of sales, including royalties, as we are not the principal.
−Removed: These arrangements resulted from an exchange of a license and utilize the sales and usage based royalty exception.
−Removed: Therefore, royalties received are recognized as the underlying sales occur.
+Added: During the first quarter of 2023 we began recognizing contract manufacturing revenue
AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: for LEQEMBI, upon accelerated approval of LEQEMBI in the U.S.
+Added: Prior to accelerated approval, our share of contract manufacturing amounts related to LEQEMBI were recognized in research and development expense within our consolidated statements of income.
+Added: Royalty and Other Revenue
+Added: Royalty and other revenue primarily reflects royalty revenue on biosimilar products from our license arrangements with Samsung Bioepis and royalties we receive from net sales on products related to patents that we have out-licensed.
+Added: As the royalties we receive relate to arrangements that resulted from an exchange of a license and utilize the sales and usage based royalty exception, the royalties are recognized as the underlying sales occur.
Collaborative and Other Relationships
1 unchanged sentence
Where we are the principal on sales transactions with third parties, we recognize revenue, cost of sales and operating expense on a gross basis in their respective lines in our consolidated statements of income.
−Removed: Where we are not the principal on sales transactions with third parties, our share of the revenue, cost of sales and operating expense is recorded as a component of other revenue in our consolidated statements of income.
+Added: Where we are not the principal on sales transactions with third parties, our share of the revenue, cost of sales and operating expense is recorded on a net basis as a component of other revenue in our consolidated statements of income.
Our development and commercialization arrangements with Genentech, Eisai, Sage and Samsung Bioepis represent collaborative arrangements as each party is an active participant in one or more joint operating activities and is exposed to significant risks and rewards of these arrangements.
7 unchanged sentences
• Level 3 — Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable.
−Removed: The majority of our financial assets have been classified as Level 2.
−Removed: Our financial assets (which typically include our cash equivalents, marketable debt securities and certain of our marketable equity securities, derivative contracts and plan assets for deferred compensation) have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing third-party pricing services or option pricing valuation models.
+Added: The majority of our financial assets have been classified as Level 2, and have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing third-party pricing services or option pricing valuation models.
The pricing services utilize industry standard valuation models, including both income and market-based approaches and observable market inputs to determine value.
3 unchanged sentences
After completing our validation procedures, we did not adjust or override any fair value measurements provided by our pricing services as of December 31, 2024 and 2023.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Other Assets and Liabilities
2 unchanged sentences
We consider only those investments that are highly liquid, readily convertible to cash and that mature within three months from date of purchase to be cash equivalents.
−Removed: As of December 31, 2023 and 2022, cash equivalents were comprised of money market funds, commercial paper, overnight reverse repurchase agreements and other debt securities with maturities less than three months from the date of purchase.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: As of December 31, 2024 and 2023, cash equivalents were comprised of money market funds with maturities less than three months from the date of purchase.
Accounts Receivable
5 unchanged sentences
In April 2022 we completed the sale of our 49.9 % equity interest in Samsung Bioepis to Samsung BioLogics, which resulted in a receivable of approximately $ 1.3 billion in cash to be deferred over two payments.
−Removed: The first deferred payment of $ 812.5 million was received in April 2023 and the second deferred payment of $ 437.5 million is due at the second anniversary of the closing of this transaction in April 2024.
−Removed: The payments due to us from Samsung BioLogics have been recorded at their estimated fair values through the use of risk-adjusted discount rates.
+Added: The first deferred payment of $ 812.5 million was received in April 2023 and the second deferred payment of $ 437.5 million was received in April 2024.
+Added: The payments due to us from Samsung BioLogics were recorded at their estimated fair values through the use of risk-adjusted discount rates.
For additional information on the accounting for the sale of our equity interest in Samsung Bioepis, please read Note 3, Dispositions , to these consolidated financial statements.
14 unchanged sentences
For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to these consolidated financial statements.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Marketable Equity Securities and Venture Capital Funds
2 unchanged sentences
Our investments in venture capital funds are recorded at net asset value, which approximates fair value, and unrealized gains and losses are included in other (income) expense, net in our consolidated statements of income.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The underlying investments of the venture capital funds in which we invest are in equity securities of certain biotechnology companies and are included in investments and other assets in our consolidated balance sheets.
5 unchanged sentences
Evaluating Marketable Debt Securities for Other-than-Temporary Impairments
−Removed: We conduct periodic reviews to identify and evaluate each investment that has an unrealized loss, in accordance with the meaning of other-than-temporary impairment.
+Added: When we hold marketable debt securities, we conduct periodic reviews to identify and evaluate each investment that has an unrealized loss, in accordance with the meaning of other-than-temporary impairment.
An unrealized loss exists when the current fair value of an individual security is less than its amortized cost basis.
12 unchanged sentences
Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in a clinical manufacturing campaign.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Capitalization of Inventory Costs
5 unchanged sentences
We consider the shelf life of the product in relation to the expected timeline for approval and we consider patent related or contract issues that may prevent or delay commercialization.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: base our judgment on the viability of commercialization, trends in the marketplace and market acceptance criteria.
+Added: We also base our judgment on the viability of commercialization, trends in the marketplace and market acceptance criteria.
Finally, we consider the reimbursement strategies that may prevail with respect to the product and assess the economic benefit that we are likely to realize.
17 unchanged sentences
If the software is an integral part of production assets, these costs are included in machinery and equipment and are amortized on a straight-line basis over the estimated useful lives of the related software, which generally range from three to five years .
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
We generally depreciate or amortize the cost of our property, plant and equipment using the straight-line method over the estimated useful lives of the respective assets, which are summarized as follows:
11 unchanged sentences
When determining the lease term, we include options to extend or terminate the lease when it is reasonably certain that they will be exercised.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
We use the implicit rate when readily determinable and use our incremental borrowing rate when the implicit rate is not readily determinable based upon the information available at the commencement date in determining the present value of the lease payments.
11 unchanged sentences
Intangible Assets
−Removed: Our intangible assets consist of completed technology (comprised of acquired and in-licensed rights and patents, developed technology and other), IPR&D acquired after January 1, 2009, priority review vouchers and trademarks and trade names.
+Added: Our intangible assets primarily consist of completed technology (comprising of acquired and in-licensed rights and patents, and developed technology), IPR&D acquired after January 1, 2009, acquired priority review vouchers and trademarks and trade names.
Our intangible assets are recorded at fair value at the time of their acquisition and are stated in our consolidated balance sheets net of accumulated amortization and impairments, if applicable.
−Removed: Intangible assets related to acquired and in-licensed rights and patents, developed technology and other are amortized over their estimated useful lives using the economic consumption method if anticipated future revenue can be reasonably estimated.
+Added: Intangible assets related to completed technology are amortized over their estimated useful lives using the economic consumption method if anticipated future revenue can be reasonably estimated.
The straight-line method is used when revenue cannot be reasonably estimated.
Amortization is recorded within amortization and impairment of acquired intangible assets in our consolidated statements of income.
−Removed: We amortize the intangible assets related to our marketed products using the economic consumption method based on revenue generated from the products underlying the related intangible assets.
−Removed: An analysis of the anticipated lifetime revenue of our marketed products is performed annually during our long-range planning cycle and whenever events or changes in circumstances would significantly affect anticipated lifetime revenue of the relevant products.
+Added: The economic consumption method is based on revenue generated from the products underlying the related intangible assets.
+Added: An analysis of the anticipated lifetime revenue of our marketed products is performed annually
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: during our long-range planning cycle and whenever events or changes in circumstances would significantly affect anticipated lifetime revenue of the relevant products.
Intangible assets related to trademarks, trade names, IPR&D prior to commercialization and priority review vouchers are not amortized because they have indefinite lives;
9 unchanged sentences
We consider multiple factors in this assessment, including the nature of the technology acquired, the presence or absence of separate cash flow, the development process and stage of completion, quantitative significance and our rationale for entering into the transaction.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
If we acquire a business as defined under applicable accounting standards, then the acquired IPR&D is capitalized as an intangible asset.
If we acquire an asset or group of assets that do not meet the definition of a business under applicable accounting standards, then the acquired IPR&D is expensed on its acquisition date.
−Removed: Future costs to develop these assets are recorded to research and development expense in our consolidated statements of income as they are incurred.
+Added: Future costs to develop these assets are recorded to research and development expense within our consolidated statements of income as they are incurred.
When performing our impairment assessment, we calculate the fair value using the same methodology as described above.
12 unchanged sentences
Long-lived assets to be disposed of are carried at fair value less costs to sell.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Contingent Consideration
10 unchanged sentences
Significant judgment is employed in determining the appropriateness of these assumptions as of the acquisition date and for each subsequent period.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Derivative Instruments and Hedging Activities
18 unchanged sentences
subsidiaries that transact in a functional currency other than the U.S.
−Removed: dollar, assets and liabilities are translated at current rates of exchange at the balance sheet date.
+Added: dollar, assets and liabilities are translated at current rates of
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: exchange at the balance sheet date.
Income and expense items are translated at the average foreign currency exchange rates for the period.
10 unchanged sentences
For example, if the level of net sales in any calendar year increases the royalty rate within the year, we will record our cost of sales at an even rate over the year, based on the estimated blended royalty rate.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Accounting for Share-Based Compensation
17 unchanged sentences
Cumulative adjustments are recorded each quarter to reflect the estimated outcome of the performance-related conditions until the date results are determined and settled.
−Removed: If performance criteria are not met or not expected to be met, any compensation expense previously recognized to date associated with the awards will be reversed.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: performance criteria are not met or not expected to be met, any compensation expense previously recognized to date associated with the awards will be reversed.
Research and Development Expense
7 unchanged sentences
We record payments received from our collaborative partners for their share of the development costs as a reduction of research and development expense, except as discussed in Note 19, Collaborative and Other Relationships, to these consolidated financial statements.
−Removed: Expenses incurred by Genentech in the ongoing development of RITUXAN,
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: GAZYVA, LUNSUMIO and other products for which an initial indication has been approved are not recorded as research and development expense, but rather reduce our share of profits recorded as a component of revenue from anti-CD20 therapeutic programs.
+Added: Expenses incurred by Genentech in the ongoing development of RITUXAN, GAZYVA, LUNSUMIO and other products for which an initial indication has been approved are not recorded as research and development expense, but rather reduce our share of profits recorded as a component of revenue from anti-CD20 therapeutic programs.
Selling, General and Administrative Expense
13 unchanged sentences
We also accrue for potential interest and penalties related to unrecognized tax benefits in income tax (benefit) expense in our consolidated statements of income.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Contingencies
12 unchanged sentences
Diluted earnings per share is computed based on the treasury method by dividing net income by the weighted-average number of common shares outstanding during the period plus potentially dilutive common equivalent shares outstanding.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Business Combinations
9 unchanged sentences
If we determine the assets acquired do not meet the definition of a business, the transaction will be accounted for as an asset acquisition rather than a business combination.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
New Accounting Pronouncements
1 unchanged sentence
Unless otherwise discussed below, we do not believe that the adoption of recently issued standards have or may have a material impact on our consolidated financial statements or disclosures.
−Removed: Segment Reporting
−Removed: In November 2023 the FASB issued ASU No.
+Added: Standard Description Effective Date Effects on the financial statements
2023-07, Segment Reporting (Topic 280):
3 unchanged sentences
All disclosure requirements under this standard are also required for public entities with a single reportable segment.
−Removed: This standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024.
−Removed: Early adoption is permitted and the amendments in this update are required to be applied on a retrospective basis.
+Added: The amendments in this update are required to be applied on a retrospective basis.
+Added: Annual reporting for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024.
+Added: Early adoption is permitted.
+Added: This standard became effective for us for our annual reporting period ended December 31, 2024, using the retrospective method.
+Added: The adoption of this standard resulted in additional disclosure on the significant expenses reviewed by our CODM.
+Added: The adoption did not have a material impact on our consolidated financial position or results of operations.
+Added: Refer to Note 25, Segment Information , for our updated segment presentation.
+Added: 2023-09, Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures
+Added: This standard establishes incremental disaggregation of income tax disclosures pertaining to the effective tax rate reconciliation and income taxes paid.
+Added: The amendments in this update are required to be applied on a prospective basis with the option to apply it retrospectively.
+Added: Annual reporting for fiscal years beginning after December 15, 2024.
+Added: Early adoption is permitted.
We are currently evaluating the potential impact that this new standard will have on our consolidated financial statements and related disclosures.
−Removed: Fair Value Measurements
−Removed: In June 2022 the FASB issued ASU No.
−Removed: 2022-03, Fair Value Measurement (Topic 820):
−Removed: Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions .
−Removed: This standard clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value.
−Removed: This standard became effective for us on January 1, 2024.
−Removed: We elected to early adopt this standard on a prospective basis during the third quarter of 2022.
−Removed: Upon adoption, we recorded an immaterial amount in other (income) expense, net in our consolidated statements of income.
+Added: 2024-03, Income Statement (Subtopic 220-40):
+Added: Reporting Comprehensive Income - Expense Disaggregation Disclosures
+Added: This standard requires disclosure in the notes to the financial statements, at each interim and annual reporting period, of specified information about certain costs and expense including purchases of inventory, employee compensation, depreciation and intangible asset amortization included in each relevant expense caption.
+Added: This standard also requires a qualitative description of the amounts remaining in relevant expense captions that are not separately disaggregated, as well as disclosure of the total amount of selling expenses, and, in annual reporting periods, an entity’s definition of selling expenses.
+Added: Annual reporting for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027.
+Added: Early adoption is permitted.
+Added: We are currently evaluating the potential impact that this new standard will have on our consolidated financial statements and related disclosures.
+Added: SEC Release No.
+Added: 33-11275, The Enhancement and Standardization of Climate-Related Disclosures for Investors
+Added: This new rule will require large accelerated filers to disclose material climate-related risks that are reasonably likely to have a material impact on their business, results of operations or financial condition.
+Added: The required information about climate-related risks will also include disclosure of material direct greenhouse gas emissions from operations owned or controlled (Scope 1) and/or material indirect greenhouse gas emissions from purchased energy consumed in owned or controlled operations (Scope 2).
+Added: Additionally, the new rules will require disclosure within the notes to the financial statements of the effects of severe weather events and other natural conditions and information on any climate-related targets or goals, subject to certain materiality thresholds.
+Added: Phased-in compliance period beginning with annual reporting for fiscal years as of December 31, 2025.
+Added: In April 2024 the SEC voluntarily stayed implementation of the new climate-related disclosure requirements pending judicial review.
+Added: Once the litigation is resolved, and if the rule remains in effect, the SEC will announce a new effective date.
+Added: We are currently evaluating the potential impact that this new rule may have on our company's disclosures.
AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: Human Immunology Biosciences
+Added: On July 2, 2024, we completed the acquisition of all of the issued and outstanding shares of HI-Bio, a privately-held clinical-stage biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases.
+Added: HI-Bio's lead asset, felzartamab, an anti-CD38 antibody, is currently being evaluated for three leading indications, AMR, PMN and IgAN.
+Added: Felzartamab has received Breakthrough Therapy Designation and ODD from the FDA for development in the treatment of PMN and AMR.
+Added: Subsequent to our acquisition, felzartamab received ODD in the E.U.
+Added: in IgAN and solid organ transplantation.
+Added: The acquisition of HI-Bio is expected to augment our pipeline and build on our expertise in immunology.
+Added: Under the terms of this acquisition, we paid shareholders of HI-Bio approximately $ 1.15 billion at closing and may pay up to an additional $ 650.0 million in potential future development and regulatory milestone payments.
+Added: The $ 1.15 billion paid includes approximately $ 74.5 million related to HI-Bio's outstanding, non-vested equity awards, inclusive of employer taxes, of which $ 56.4 million was recognized as share-based compensation payments to settle non-vested equity awards attributable to the post-acquisition service period and therefore not reflected as a component of total purchase price paid.
+Added: Of the total $ 56.4 million, we recognized approximately $ 42.5 million as a charge to research and development expense with the remaining $ 13.9 million as a charge to selling, general and administrative expense within our consolidated statements of income for the year ended December 31, 2024 .
+Added: These amounts were associated with the accelerated vesting of stock options and RSUs previously granted to HI-Bio employees and required no future services to vest.
+Added: Upon closing we also paid an additional $ 43.7 million related to working capital adjustments as of the transaction close date, which was included as a component of total purchase price paid.
+Added: We funded this acquisition through available cash on hand and accounted for this acquisition as a business combination using the acquisition method of accounting in accordance with ASC Topic 805, Business Combinations , and recorded assets acquired and liabilities assumed at their respective fair values as of the acquisition date.
+Added: In addition to the lead program felzartamab, the HI-Bio pipeline acquired includes izastobart/HIB210, an anti-C5aR1 antibody currently in a Phase 1 trial, and the potential for continued development in a range of complement-mediated diseases.
+Added: Purchase Price Consideration
+Added: Total consideration transferred for the acquisition of HI-Bio is summarized as follows:
+Added: (In millions) As of July 2, 2024
+Added: Cash consideration paid to HI-Bio shareholders (1)
+Added: Contingent consideration 485.1
+Added: Total consideration $ 1,622.4
+Added: (1) Represents total consideration paid to shareholders of HI-Bio of $ 1.15 billion, plus an additional $ 43.7 million related to working capital adjustments as of the transaction close date, less $ 56.4 million of cash paid for HI-Bio's outstanding, non-vested equity awards, inclusive of employer taxes, which were recognized as compensation attributable to the post-acquisition service period and therefore not reflected as a component of total consideration.
+Added: Contingent Consideration:
+Added: We may make certain contingent payments to the former shareholders of HI-Bio upon the achievement of certain development and regulatory milestones.
+Added: As of the acquisition date, the maximum aggregate amount payable for these potential milestones was $ 650.0 million .
+Added: The acquisition-date fair value of these milestones was approximately $ 485.1 million and was estimated utilizing a probability-adjusted discounted cash flow calculation using an appropriate discount rate dependent on the nature and timing of the milestone payments, which ranged from 6.2 % to 7.0 %, and probabilities of technological and regulatory success ranging from 67.0 % to near-certain probability.
+Added: Of the total contingent consideration, approximately $ 279.3 million related to milestones classified as short-term and reflected as a component of accrued expense and other with the remaining $ 205.8 million reflected as a component of other long-term liabilities within our consolidated balance sheets.
+Added: The short-term liability relates to the fourth patient dosed in a phase 3 clinical trial of felzartamab in a first and s econd indication, which would trigger milestone payments of $ 150.0 million each.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: Subsequent changes in the fair value of the contingent consideration obligation will be recognized as (gain) loss on fair value remeasurement of contingent consideration within our consolidated statements of income.
+Added: This fair value measurement was based on significant inputs that are not observable in the market and thus represent Level 3 fair value measurements.
+Added: For additional information related to the fair value of this obligation, please read Note 8, Fair Value Measurements , to these consolidated financial statements.
+Added: Other Contractual Commitments:
+Added: We acquired HI-Bio's pre-existing in-license commitments under third-party agreements, which include tiered royalties on potential future sales of felzartamab and izastobart/HIB210, ranging from high-single digit to mid-teen percentages, as well as potential future development, regulatory and commercial milestone payments related to felzartamab and izastobart/HIB210 of up to $ 130.0 million, $ 230.0 million and $ 640.0 million, respectively.
+Added: Because the achievement of these milestones was not considered probable as of the transaction close date, such contingencies have not been recorded in our financial statements.
+Added: Preliminary Purchase Price Allocation
+Added: The following table summarizes the preliminary purchase price allocation of the separately identifiable assets acquired and liabilities assumed as of July 2, 2024:
+Added: (In millions) Estimated Fair Value
+Added: Cash and cash equivalents $ 62.5
+Added: Intangible assets:
+Added: IPR&D - felzartamab (IgAN) 920.0
+Added: IPR&D - felzartamab (AMR)
+Added: IPR&D - felzartamab (PMN) 265.0
+Added: Other clinical programs 7.9
+Added: Prepaid expense and other assets 1.0
+Added: Operating lease assets 1.2
+Added: Accounts payable ( 1.1 )
+Added: Accrued liabilities ( 35.0 )
+Added: Deferred tax liability ( 304.4 )
+Added: Operating lease liabilities ( 1.2 )
+Added: Total identifiable net assets 1,365.9
+Added: Goodwill 256.5
+Added: Total assets acquired and liabilities assumed $ 1,622.4
+Added: There were no material purchase price allocation adjustments for the year ended December 31, 2024.
+Added: Intang ible assets:
+Added: Intangible assets comprised of $ 1.6 billion of IPR&D related to HI-Bio's lead asset felzartamab.
+Added: This includes $ 920.0 million of IPR&D related to felzartamab indication for IgAN, $ 450.0 million of IPR&D related to felzartamab indication for AMR and $ 265.0 million of IPR&D related to felzartamab indication for PMN.
+Added: The estimated fair values of the program related intangible assets were determined using a multi-period excess earnings method, a form of the income approach, utilizing cash flow analyses and a discount rate of 14.5 %.
+Added: These fair value measurements were based on significant inputs that are not observable in the market and thus represent Level 3 fair value measurements.
+Added: Goodwill was calculated as the excess of the consideration transferred over the net assets recognized and represents the future economic benefits arising from the other assets acq uired that could not be individually identified and separately recognized.
+Added: We recognized goodwill of approximately $ 256.5 million, which is not deductible for tax purposes.
+Added: The goodwill recognized from our acquisition of HI-Bio is primarily the result of the deferred tax consequences from the transaction recorded for financial statement purposes.
+Added: Acquisition-related expense:
+Added: Acquisition-related expense, primarily comprised of advisory and legal fees, and other transaction costs, totaled approximately $ 2.8 million and were recorded within selling, general and administrative expense within our consolidated statements of income for the year ended December 31, 2024.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: Assumptions in the Allocations of Purchase Price
+Added: T he results of operations of HI-Bio, along with the estimated fair values of the assets acquired and liabilities assumed in the HI-Bio acquisition, have been included in our consolidated financial statements since the closing of the HI-Bio acquisition on July 2, 2024.
+Added: Our preliminary estimate of the fair value of the specifically identifiable assets acquired and liabilities assumed as of the date of acquisition is subject to the finalization of management's analysis related to certain matters, such as finalizing our assessment of income taxes.
+Added: The final determination of these fair values will be completed as additional information becomes available but no later than one year from the acquisition date.
+Added: The final determination may result in asset and liability fair values that are different than the preliminary estimates.
+Added: Subsequent to the acquisition date, our results of operations include the results of operations of HI-Bio.
+Added: HI-Bio operations had an immaterial impact on our results of operations for the year ended December 31, 2024.
+Added: Due to the immateriality of HI-Bio's historic revenue and expenses, additional pro forma information combining the results of operations of Biogen and HI-Bio have not been included.
Reata Pharmaceuticals, Inc.
1 unchanged sentence
As a result of this transaction we acquired SKYCLARYS (omaveloxolone), the first and only drug approved in the U.S.
−Removed: for the treatment of Friedreich's Ataxia in adults and adolescents aged 16 years and older, as well as other clinical and preclinical pipeline programs.
+Added: for the treatment of FA in adults and adolescents aged 16 years and older, as well as other clinical and preclinical pipeline programs.
The acquisition of Reata is expected to complement our global portfolio of neuromuscular and rare disease therapies.
4 unchanged sentences
These amounts were associated with the accelerated vesting of stock options and RSUs previously granted to Reata employees that required no future services to vest.
−Removed: We funded this acquisition through available cash, cash equivalents and marketable securities, supplemented by the issuance of a $ 1.0 billion term loan under our term loan credit agreement.
−Removed: For additional information on our term loan credit agreement, please read Note 13, Indebtedness , to these consolidated financial statements.
+Added: We funded this acquisition through available cash, cash equivalents and marketable securities, supplemented by the issuance of a $ 1.0 billion term loan under our 2023 Term Loan.
+Added: For additional information on our 2023 Term Loan, please read Note 13, Indebtedness , to these consolidated financial statements.
We accounted for this acquisition as a business combination using the acquisition method of accounting in accordance with ASC Topic 805, Business Combinations , and recorded assets acquired and liabilities assumed at their respective fair values as of the acquisition date.
9 unchanged sentences
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: Preliminary Purchase Price Allocation
−Removed: The following table summarizes the provisional amounts recognized for assets acquired and liabilities assumed as of the acquisition date, as well as measurement period adjustments made year-to-date to the amounts initially recorded as of the acquisition date on September 26, 2023.
+Added: Purchase Price Allocation
+Added: We finalized purchase accounting for this acquisition in the third quarter of 2024.
+Added: The following table summarizes the amounts recognized for assets acquired and liabilities assumed as of the acquisition date, and reflects measurement period adjustments made to the amounts initially recorded as of the acquisition date on September 26, 2023.
The measurement period adjustments summarized below resulted from updates to our valuation assumptions related to the estimated amounts and timing of future cash flows associated with certain intangible assets, updates of our assumptions related to the quantities, selling location and remaining manufacturing and selling costs of acquired inventory, and other assets and liabilities.
1 unchanged sentence
(In millions) Amounts Recognized as of Acquisition Date
−Removed: (as previously reported)
−Removed: Measurement Period Adjustments Amounts Recognized as of Acquisition Date
(as adjusted)
12 unchanged sentences
Contingent payable to Blackstone ( 300.0 )
−Removed: ( 300.0 ) — ( 300.0 )
Deferred tax liability (1)
Operating lease liabilities ( 151.8 )
−Removed: ( 151.8 ) — ( 151.8 )
Other assets and liabilities, net ( 2.5 )
Total identifiable net assets 6,724.2
−Removed: Goodwill 1,057.3 ( 592.8 ) 464.5
Total assets acquired and liabilities assumed $ 7,193.4
−Removed: (1) For additional information on the contingent payable to Blackstone, please read Note 18, Other Consolidated Financial Statement Detail , to these consolidated financial statements.
+Added: (1) Includes measurement period adjustments recorded in 2024 that increased other current assets by $ 1.0 million, accrued expense and other by $ 8.8 million and goodwill by $ 4.7 million, and decreased deferred tax liability by $ 3.1 million.
Total inventory acquired was approximately $ 1.3 billion, which reflects a step-up in the fair value of finished goods and work-in-process inventory for SKYCLARYS.
The fair value was determined based on the estimated selling price of the inventory, less the remaining manufacturing and selling costs and a normal profit margin on those manufacturing and selling efforts.
−Removed: This fair value step-up adjustment will be amortized to cost of sales within our consolidated statements of income when the inventory is sold, which is expected to be within approximately 3 years from the acquisition date.
−Removed: For the year ended December 31, 2023, amortization from the fair value step-up adjustment as a result of inventory sold during the fourth quarter was approximately $ 31.5 million.
−Removed: Intang ible assets:
−Removed: Intangible assets are comprised of $ 4.2 billion related to SKYCLARYS commercialization rights in the U.S., $ 2.3 billion of IPR&D related to the omaveloxolone program outside the U.S., which had not yet received regulatory approval in the E.U.
−Removed: as of the acquisition date, $ 100.0 million related to a rare pediatric disease priority voucher which may be used to obtain priority review by the FDA for a future regulatory submission or sold to a third party and $ 40.0 million related to other clinical programs.
−Removed: The estimated fair values of the program related intangible assets were determined using a multi-period excess earnings method, a form of the income approach, utilizing a discount rate of 14.3 % and the estimated fair value of the priority review voucher was based on recent external purchase and sale transactions of similar vouchers.
+Added: This fair value step-up adjustment is being amortized to cost of sales within our consolidated statements of income as the inventory is sold, which is expected to be sold over a period of approximately 4 years from the acquisition date.
+Added: For the years ended December 31, 2024 and 2023, amortization from the fair value step-up adjustment was approximately $ 230.0 million and $ 31.5 million, respectively.
+Added: For the year ended December 31, 2024, amortization from the fair value step-up adjustment includes approximately $ 48.5 million of inventory used for clinical purposes, which is reflected within research and development expense within our consolidated statements of income.
AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: Intang ible assets:
+Added: Intangible assets are comprised of $ 4.2 billion related to SKYCLARYS commercialization rights in the U.S., $ 2.3 billion of IPR&D related to the omaveloxolone program outside the U.S., which had not yet received regulatory approval in the E.U.
+Added: as of the acquisition date, $ 100.0 million related to a rare pediatric disease PRV which may be used to obtain priority review by the FDA for a future regulatory submission or sold to a third party and $ 40.0 million related to other clinical programs.
+Added: The estimated fair values of the program related intangible assets were determined using a multi-period excess earnings method, a form of the income approach, utilizing a discount rate of 14.3 % and the estimated fair value of the PRV was based on recent external purchase and sale transactions of similar vouchers.
Our valuation of the SKYCLARYS commercialization rights reflects the assumption that, using an economic consumption model, the related $ 4.2 billion intangible asset will be amortized over its expected economic life.
−Removed: Our valuation of the $ 2.3 billion IPR&D asset relates to omaveloxolone, which was submitted to the EMA in 2023 and subsequently approved in the E.U.
−Removed: in February 2024.
−Removed: We expect sales to commence in certain countries in Europe during 2024, at which time we will begin amortizing the intangible asset over its expected economic life.
+Added: Upon SKYCLARYS receiving regulatory approval in the E.U.
+Added: in February 2024, we began selling the product in certain countries in Europe, and began amortizing the $ 2.3 billion IPR&D asset related to the program outside the U.S.
+Added: over its expected economic life using an economic consumption model.
These fair value measurements were based on significant inputs not observable in the market and thus represent Level 3 fair value measurements.
4 unchanged sentences
Goodwill was calculated as the excess of the consideration transferred over the net assets recognized and represents the future economic benefits arising from the other assets acquired that could not be individually identified and separately recognized.
−Removed: We recognized goodwill of approximately $ 464.5 million, which is not deductible for tax purposes.
+Added: We recognized goodwill of approximately $ 469.2 million, which includes measurement period adjustments, and is not deductible for tax purposes.
The goodwill recognized from our acquisition of Reata is primarily the result of the deferred tax consequences from the transaction recorded for financial statement purposes.
−Removed: Acquisition-related expenses:
−Removed: Acquisition-related expenses, which were comprised primarily of regulatory, advisory and legal fees, and other transaction costs, totaled approximately $ 28.4 million and are included within selling, general and administrative expense within our consolidated statements of income for the year ended December 31, 2023.
−Removed: Assumptions in the Allocations of Purchase Price
−Removed: T he results of operations of Reata, along with the estimated fair values of the assets acquired and liabilities assumed in the Reata acquisition, have been included in our consolidated financial statements since the closing of the Reata acquisition on September 26, 2023 .
−Removed: Our preliminary estimate of the fair value of the specifically identifiable assets acquired and liabilities assumed as of the date of acquisition is subject to the finalization of management's analysis related to certain matters, such as finalizing our assessment of income taxes.
−Removed: The final determination of these fair values will be completed as additional information becomes available but no later than one year from the acquisition date.
−Removed: The final determination may result in asset and liability fair values that are different than the preliminary estimates.
−Removed: Subsequent to the acquisition date, our results of operations include the results of operations of Reata.
−Removed: Due to the immateriality of Reata's revenue and expense, additional pro forma information combining the results of operations of Biogen and Reata have not been included.
+Added: Acquisition-related expense:
+Added: Acquisition-related expense, primarily comprised of regulatory, advisory and legal fees, and other transaction costs, totaled approximately $ 28.4 million and were recorded in selling, general and administrative expense within our consolidated statements of income for the year ended December 31, 2023.
Sale of Joint Venture Equity Interest in Samsung Bioepis
1 unchanged sentence
Under the terms of this transaction, we received approximately $ 1.0 billion in cash at closing, with approximately $ 1.3 billion in cash to be deferred over two payments.
−Removed: The first deferred payment of $ 812.5 million was received in April 2023 and the second deferred payment of $ 437.5 million is due at the second anniversary of the closing of this transaction in April 2024.
+Added: The first deferred payment of $ 812.5 million was received in April 2023 and the second deferred payment of $ 437.5 million was received in April 2024.
Prior to the sale, the carrying value of our investment in Samsung Bioepis totaled $ 581.6 million.
1 unchanged sentence
This pre-tax gain included reclassifications from AOCI to net income of approximately $ 58.9 million in cumulative translation losses, partially offset by approximately $ 57.0 million in gains resulting from the termination of our net investment hedge.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
We concluded that the divestment of Samsung Bioepis did not meet the criteria to be reported as discontinued operations in our consolidated financial statements, as our decision to divest this business did not represent a strategic shift that would have a major effect on our operations and financial results.
1 unchanged sentence
As of December 31, 2023, the estimated fair value of the remaining second deferred payment using a risk-adjusted discount rate of 5.8 % was approximately $ 430.0 million .
−Removed: This payment has been classified as a Level 3 measurement and is reflected in other current assets within our consolidated balance sheets as of December 31, 2023.
−Removed: For the year ended December 31, 2023, we recognized a gain of approximately $ 13.7 million to reflect the change in fair value related to the first deferred payment due to us, which was received in April 2023.
−Removed: Additionally, for the year ended December 31, 2023, we recognized a gain of approximately $ 24.6 million to reflect the change in fair value related to the second deferred payment due to us.
−Removed: For the year ended December 31, 2022, we recognized a gain of approximately $ 10.7 million and a loss of approximately $ 1.4 million to reflect the changes in fair value related to the first and second deferred payments due to us, respectively.
+Added: This payment has been classified as a Level 3 fair value
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: measurement and is reflected in other current assets within our consolidated balance sheets as of December 31, 2023.
+Added: For the year ended December 31, 2024, we recognized a gain of approximately $ 7.5 million to reflect the change in fair value associated with the passage of time related to the second deferred payment due to us, which was received in April 2024.
+Added: For the year ended December 31, 2023, we recognized gains of approximately $ 13.7 million and $ 24.6 million to reflect the changes in fair value associated with changes in interest rates and the passage of time related to the first and second deferred payments due to us, respectively, which were received in April 2023 and April 2024, respectively.
+Added: For the year ended December 31, 2022, we recognized a gain of approximately $ 10.7 million and a loss of approximately $ 1.4 million to reflect the changes in fair value associated with changes in interest rates and the passage of time related to the first and second deferred payments due to us, respectively, which were received in April 2023 and April 2024, respectively.
These changes were recorded in other (income) expense, net within our consolidated statements of income.
1 unchanged sentence
Our policy for contingent payments of this nature is to recognize the payments in the period the payments become realizable, which is generally the same period in which the payments are earned.
−Removed: If any payments due to us remain outstanding after the second anniversary of the closing of this transaction, we may elect to receive shares of Samsung BioLogics common stock at a 5.0 % discount in lieu of a cash payment for the remaining amount due.
−Removed: Currently, we believe that the likelihood of Samsung BioLogics failing to make the second deferred payment due to us is remote.
Additionally, for the year ended December 31, 2022, we recorded a discrete tax expense of approximately $ 257.9 million related to this transaction, which is reflected in income tax (benefit) expense in our consolidated statements of income.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: Sale of Priority Review Voucher
+Added: In April 2024 we completed the sale of our rare pediatric disease PRV, generated by the development associated with SPINRAZA, to a third party.
+Added: In consideration for the PRV we received a cash payment of $ 103.0 million upon the closing of the PRV purchase, of which approximately $ 14.4 million was paid to Ionis.
+Added: Our net portion of approximately $ 88.6 million was recognized in gain on sale of priority review voucher, net within our consolidated statements of income for the year ended December 31, 2024.
Restructuring
1 unchanged sentence
In 2023 we initiated additional cost saving measures as part of our Fit for Growth program to reduce operating costs, while improving operating efficiency and effectiveness.
−Removed: The Fit for Growth program is expected to generate approximately $ 1.0 billion in gross operating expense savings by 2025, some of which will be reinvested in various initiatives.
+Added: The Fit for Growth program is expected to generate approximately $ 1.0 billion in gross operating expense savings by the end of 2025, some of which will be reinvested in various initiatives.
The Fit for Growth program is currently estimated to include net headcount reductions of approximately 1,000 employees and we expect to incur restructuring charges ranging from approximately $ 260.0 million to $ 280.0 million.
−Removed: Total charges incurred from our 2023 cost saving initiatives are summarized as follows:
−Removed: For the Year Ended December 31,
−Removed: (In millions) Severance
+Added: Total charges incurred from our 2023 Fit for Growth program are summarized as follows:
+Added: For the Years Ended December 31,
+Added: (In millions) Severance Costs Accelerated Depreciation and Other Costs Total Severance
Costs Accelerated Depreciation and Other Costs Total
4 unchanged sentences
includes costs associated with items such as asset abandonment and write-offs, facility closure costs, pretax gains and losses resulting from the termination of certain leases, employee non-severance expense, consulting fees and other costs.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Reata Integration
−Removed: Following the close of our Reata acquisition, we implemented an integration plan designed to realize operating synergies through cost savings and avoidance.
−Removed: These amounts are primarily related to severance and are expected to be paid by the end of 2024.
−Removed: For the year ended December 31, 2023, we recognized approximately $ 30.4 million of net pre-tax restructuring charges related to employee severance costs.
+Added: Following the close of our Reata acquisition in September 2023, we implemented an integration plan designed to realize operating synergies through cost savings and avoidance.
+Added: Under this initiative, we estimate we will incur total integration charges of approximately $ 35.0 million, related to severance and employment costs.
+Added: These severance and employment costs were substantially incurred during 2023.
+Added: Total charges incurred from our Reata integration are summarized as follows:
+Added: For the Years Ended December 31,
+Added: (In millions) Severance Costs Accelerated Depreciation and Other Costs Total Severance Costs Accelerated Depreciation and Other Costs Total
+Added: Selling, general and administrative $ — $ 6.3 $ 6.3 $ — $ — $ —
+Added: Research and development — 11.9 11.9 — — —
+Added: Restructuring charges 3.4 — 3.4 30.4 — 30.4
+Added: Total charges $ 3.4 $ 18.2 $ 21.6 $ 30.4 $ — $ 30.4
+Added: In connection with our acquisition of Reata we assumed responsibility for a single-tenant, build-to-suit building of approximately 327,400 square feet of office and laboratory space located in Plano, Texas, with an initial lease term of 16 years.
+Added: We do not intend to occupy this building and are evaluating opportunities to sublease the property.
+Added: For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to these consolidated financial statements.
+Added: HI-Bio Integration
+Added: Following the close of our HI-Bio acquisition in July 2024, we implemented an integration plan designed to realize operating synergies through cost savings and avoidance.
+Added: Under this initiative, we incurred approximately $ 2.6 million of severance and employment costs, which are reflected in restructuring charges within our consolidated statements of income for the year ended December 31, 2024 .
+Added: For additional information on our acquisition of HI-Bio, please read Note 2, Acquisitions , to these consolidated financial statements.
2022 Cost Saving Initiatives
12 unchanged sentences
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: Charges and spending related to our 2023 and 2022 workforce reductions and Reata integration are summarized as follows:
−Removed: (In millions) Total
+Added: Charges and spending related to workforce reductions are summarized as follows:
+Added: (In millions) Workforce Reductions
Restructuring reserve, December 31, 2022 $ 35.9
3 unchanged sentences
Restructuring reserve, December 31, 2023 75.4
−Removed: Expense 181.6
Payment ( 73.8 )
25 unchanged sentences
SPINRAZA 625.7 947.5 1,573.2 610.5 1,130.7 1,741.2 600.2 1,193.3 1,793.5
−Removed: 5.8 0.1 5.9 — — — — — —
SKYCLARYS (1)
301.1 81.4 382.5 55.9 — 55.9 — — —
+Added: 20.9 11.5 32.4 5.8 0.1 5.9 — — —
Rare Disease 947.7 1,040.4 1,988.1 672.2 1,130.8 1,803.0 600.2 1,193.3 1,793.5
3 unchanged sentences
23.0 13.6 36.6 29.2 2.5 31.7 4.3 — 4.3
+Added: TOFIDENCE (4)
+Added: 1.1 — 1.1 — — — — — —
Biosimilars 24.1 769.0 793.1 29.2 740.8 770.0 4.3 746.8 751.1
72.2 — 72.2 1.6 — 1.6 — — —
−Removed: Total product revenue $ 3,141.4 $ 4,105.3 $ 7,246.7 $ 3,469.3 $ 4,518.5 $ 7,987.8 $ 3,805.7 $ 5,041.2 $ 8,846.9
−Removed: (1) QALSODY became commercially available in the U.S.
−Removed: during the second quarter of 2023.
+Added: 2.8 7.5 10.3 2.4 7.8 10.2 4.8 8.2 13.0
+Added: Other 75.0 7.5 82.5 4.0 7.8 11.8 4.8 8.2 13.0
+Added: Total product revenue, net $ 3,237.3 $ 3,976.2 $ 7,213.5 $ 3,141.4 $ 4,105.3 $ 7,246.7 $ 3,469.3 $ 4,518.5 $ 7,987.8
(1) SKYCLARYS was obtained as part of our acquisition of Reata in September 2023.
2 unchanged sentences
during the fourth quarter of 2023, subsequent to our acquisition.
−Removed: (3) BYOOVIZ became commercially available in the U.S.
−Removed: during the third quarter of 2022 and commercially available in certain international markets in 2023.
−Removed: (4) Other includes FUMADERM, ADUHELM and ZURZUVAE, which became commercially available in the U.S.
+Added: SKYCLARYS was approved and became commercially available in the E.U.
+Added: during the first quarter of 2024.
+Added: (2) QALSODY became commercially available in the U.S.
+Added: during the second quarter of 2023 and commercially available in the E.U.
+Added: during the second quarter of 2024.
+Added: (3) BYOOVIZ became commercially available in certain international markets in 2023.
+Added: (4) TOFIDENCE became commercially available in the U.S.
+Added: during the second quarter of 2024.
+Added: (5) ZURZUVAE became commercially available in the U.S.
during the fourth quarter of 2023.
−Removed: We recognized revenue from two wholesalers accounting for 27.0 % and 9.9 % of gross product revenue in 2023, 26.8 % and 11.1 % of gross product revenue in 2022 and 28.8 % and 10.1 % of gross product revenue in 2021, respectively.
−Removed: As of December 31, 2023, two wholesale distributors individually accounted for approximately 24.6 % and 11.6 % of net accounts receivable associated with our product sales, as compared to 22.7 % and 10.9 % as of December 31, 2022, respectively.
+Added: (6) Other includes FUMADERM and ADUHELM.
AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: We recognized revenue from two wholesalers accounting for 25.9 % and 13.4 % of gross product revenue in 2024, 27.0 % and 9.9 % of gross product revenue in 2023 and 26.8 % and 11.1 % of gross product revenue in 2022, respectively.
+Added: As of December 31, 2024, two wholesale distributors individually accounted for approximately 27.2 % and 11.7 % of net accounts receivable associated with our product sales, as compared to 24.6 % and 11.6 % as of December 31, 2023, respectively.
An analysis of the change in reserves for discounts and allowances is summarized as follows:
2 unchanged sentences
Adjustments Returns Total
−Removed: Beginning balance $ 153.8 $ 857.7 $ 23.5 $ 1,035.0
+Added: Balance, December 31, 2023 $ 173.3 $ 857.1 $ 31.6 $ 1,062.0
Current provisions relating to sales in current year 824.2 2,687.5 23.6 3,535.3
2 unchanged sentences
Payments/credits relating to sales in prior years ( 171.9 ) ( 635.4 ) ( 20.7 ) ( 828.0 )
−Removed: Ending balance $ 173.3 $ 857.1 $ 31.6 $ 1,062.0
+Added: Balance, December 31, 2024 $ 162.7 $ 880.8 $ 48.1 $ 1,091.6
December 31, 2023
1 unchanged sentence
Adjustments Returns Total
−Removed: Beginning balance $ 137.7 $ 759.6 $ 38.0 $ 935.3
+Added: Balance, December 31, 2022 $ 153.8 $ 857.7 $ 23.5 $ 1,035.0
Current provisions relating to sales in current year 735.6 2,720.1 19.0 3,474.7
2 unchanged sentences
Payments/credits relating to sales in prior years ( 142.8 ) ( 737.5 ) ( 28.0 ) ( 908.3 )
−Removed: Ending balance $ 153.8 $ 857.7 $ 23.5 $ 1,035.0
+Added: Balance, December 31, 2023 $ 173.3 $ 857.1 $ 31.6 $ 1,062.0
December 31, 2022
1 unchanged sentence
Adjustments Returns Total
−Removed: Beginning balance $ 141.4 $ 1,093.0 $ 41.6 $ 1,276.0
+Added: Balance, December 31, 2021 $ 137.7 $ 759.6 $ 38.0 $ 935.3
Current provisions relating to sales in current year 666.6 2,715.5 12.3 3,394.4
2 unchanged sentences
Payments/credits relating to sales in prior years ( 132.8 ) ( 558.1 ) ( 18.4 ) ( 709.3 )
−Removed: Ending balance $ 137.7 $ 759.6 $ 38.0 $ 935.3
+Added: Balance, December 31, 2022 $ 153.8 $ 857.7 $ 23.5 $ 1,035.0
The total reserves above, which are included in our consolidated balance sheets, are summarized as follows:
21 unchanged sentences
For additional information on our collaboration arrangements with Genentech, please read Note 19, Collaborative and Other Relationships , to these consolidated financial statements.
+Added: Alzheimer's Collaboration Revenue
+Added: Alzheimer's collaboration revenue consists of our 50.0 % share of LEQEMBI product revenue, net and cost of sales, including royalties, as we are not the principal.
+Added: We began recognizing Alzheimer's collaboration revenue upon the accelerated approval of LEQEMBI in the U.S.
+Added: during the first quarter of 2023.
+Added: For the year ended December 31, 2024, we recognized approximately $ 59.9 million of Alzheimer's collaboration revenue within our consolidated statements of income.
+Added: For the year ended December 31, 2023, our share of LEQEMBI product revenue, net, was fully offset by our share of cost of sales, including royalties, resulting in a zero net impact to Alzheimer's collaboration revenue within our consolidated statements of income.
+Added: For additional information on our collaboration arrangements with Eisai, please read Note 19, Collaborative and Other Relationships , to these consolidated financial statements.
Contract Manufacturing, Royalty and Other Revenue
12 unchanged sentences
As a result we were entitled to $ 500.0 million in a series of three payments.
−Removed: The first payment became due upon a regulatory approval of such product and was received during the second quarter of 2020.
−Removed: The second payment became due upon the first anniversary of the regulatory approval and was received during the second quarter of 2021.
−Removed: The third payment became due upon the second anniversary of the regulatory approval and was received during the second quarter of 2022.
−Removed: Royalty and Other Revenue
−Removed: Royalty and other revenue primarily reflects the royalties we receive from net sales on products related to patents that we have out-licensed, as well as royalty revenue on biosimilar products from our license arrangements with Samsung Bioepis and our 50.0 % share of LEQEMBI product revenue, net and cost of sales, including royalties, as we are not the principal.
−Removed: For additional information on our collaboration arrangements with Eisai and our license arrangements with Samsung Bioepis, please read Note 19, Collaborative and Other Relationships , to these consolidated financial statements.
+Added: The third and final payment became due upon the second anniversary of the regulatory approval and was received during the second quarter of 2022.
AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: Royalty and Other Revenue
+Added: Royalty and other revenue primarily reflects royalty revenue on biosimilar products from our license arrangements with Samsung Bioepis and royalties we receive from net sales on products related to patents that we have out-licensed.
+Added: For additional information on our license arrangements with Samsung Bioepis and our collaboration arrangements with Eisai, please read Note 19, Collaborative and Other Relationships , to these consolidated financial statements.
The components of inventory are summarized as follows:
9 unchanged sentences
Total inventory $ 2,554.4 $ 2,609.1
+Added: Long-term inventory is included in investments and other assets within our consolidated balance sheets.
We recorded approximately $ 1.3 billion of acquired inventory, which includes measurement period adjustments, related to SKYCLARYS as a result of our acquisition of Reata in September 2023.
+Added: The fair value was determined based on the estimated selling price of the inventory, less the remaining manufacturing and selling costs and a normal profit margin on those manufacturing and selling efforts.
+Added: This fair value step-up adjustment is being amortized to cost of sales within our consolidated statements of income as the inventory is sold, which is expected to be sold over a period of approximately 4 years from the acquisition date.
+Added: For the years ended December 31, 2024 and 2023, amortization from the fair value step-up adjustment was approximately $ 230.0 million and $ 31.5 million, respectively.
+Added: For the year ended December 31, 2024, amortization from the fair value step-up adjustment includes approximately $ 48.5 million of inventory used for clinical purposes, which is reflected within research and development expense within our consolidated statements of income.
For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to these consolidated financial statements.
−Removed: Long-term inventory is included in investments and other assets in our consolidated balance sheets.
Write Downs and Other Charges
2 unchanged sentences
We recognized approximately $ 136.0 million related to Eisai's 45.0 % share of these charges in collaboration profit sharing/(loss reimbursement) within our consolidated statements of income for the year ended December 31, 2022.
−Removed: During the fourth quarter of 2021 we wrote-off approximately $ 120.0 million of inventory in excess of forecasted demand related to ADUHELM, which was recognized in cost of sales within our consolidated statements of income for the year ended December 31, 2021.
−Removed: We have recognized approximately $ 59.0 million related to Eisai's 45.0 % share of these charges in collaboration profit sharing/(loss reimbursement) within our consolidated statements of income for the year ended December 31, 2021.
−Removed: As of December 31, 2023 and 2022, the carrying value of ADUHELM inventory was zero.
−Removed: In November 2023 we notified Neurimmune of our decision to terminate our collaboration and license agreement with Neurimmune and to discontinue the development and commercialization of ADUHELM.
For additional information on our collaboration with Eisai, please read Note 19, Collaborative and Other Relationships , to these consolidated financial statements.
−Removed: For additional information on the discontinuation of ADUHELM, please read Note 20, Investments in Variable Interest Entities , to these consolidated financial statements.
AND SUBSIDIARIES
7 unchanged sentences
Amortization Net
−Removed: Completed technology
−Removed: Acquired and in-licensed rights and patents
−Removed: $ 8,180.2 $ ( 2,440.7 ) $ 5,739.5 $ 3,866.6 $ ( 2,219.1 ) $ 1,647.5
−Removed: Developed technology and other
−Removed: 13 - 31 years
−Removed: 3,548.6 ( 3,429.1 ) 119.5 3,548.7 ( 3,410.1 ) 138.6
−Removed: Total completed technology
+Added: Completed technology 1 - 31 years
$ 14,138.4 $ ( 6,254.1 ) $ 7,884.3 $ 11,728.8 $ ( 5,869.8 ) $ 5,859.0
5 unchanged sentences
Amortization and impairment of acquired intangible assets totaled $ 446.7 million, $ 240.6 million and $ 365.9 million for the years ended December 31, 2024, 2023 and 2022, respectively.
−Removed: For the year ended December 31, 2023, we had no impairment charges.
Amortization of acquired intangible assets, excluding impairment charges, totaled $ 386.5 million, $ 240.6 million and $ 246.3 million for the years ended December 31, 2024, 2023 and 2022, respectively.
−Removed: The decrease in amortization of acquired intangible assets, excluding impairment charges, over the three years was primarily due to a lower rate of amortization for acquired intangible assets.
−Removed: For the year ended December 31, 2022 , amortization and impairment of acquired intangible assets reflects the impact of a $ 119.6 million impairment charge related to vixotrigi ne (BIIB074) for the potential treatment of DPN.
−Removed: For the year ended December 31, 2021, amortization and impairment of acquired intangible assets reflects the impact of a $ 365.0 million impairment charge related to BIIB111 (timrepigene emparvovec), a $ 220.0 million impairment charge related to BIIB112 (cotoretigene toliparvovec) and a $ 44.3 million impairment charge related to vixotrigine for the potential treatment of TGN.
+Added: The increase in amortization of acquired intangible assets, excluding impairment charges, was primarily due to amortization for the Reata acquisition acquired intangible assets associated with SKYCLARYS.
+Added: For the year ended December 31, 2024 , amortization and impairment of acquired intangible assets reflects the impact of a $ 40.0 million impairment charge related to intangible assets from other clinical programs we acquired from Reata, reducing the remaining book value of these IPR&D intangible assets to zero , and a $ 20.2 million impairment charge related to intangible assets associated with Samsung Bioepis commercialization rights terminated during the third quarter of 2024.
+Added: For the year ended December 31, 2023, we had no impairment charges.
+Added: For the year ended December 31, 2022, amortization and impairment of acquired intangible assets reflects the impact of a $ 119.6 million impairment charge related to vixotrigine (BIIB074) for the potential treatment of DPN, which was discontinued during the fourth quarter of 2022 based on regulatory, development and commercialization challenges, reducing the remaining book value of this IPR&D intangible asset to zero.
+Added: We also adjusted the value of our contingent consideration obligations related to this asset resulting in a pre-tax gain of approximately $ 209.1 million , which was recognized in (gain) loss on fair value remeasurement of contingent consideration within our consolidated statements of income for the year ended December 31, 2022.
We monitor events and expectations regarding product performance.
3 unchanged sentences
Completed technology primarily relates to our other marketed products and programs acquired through asset acquisitions, licenses and business combinations.
−Removed: Completed technology intangible assets are amortized over their estimated useful lives, which range between 2 to 31 years, with a remaining weighted average useful life of 12 years for acquired and in-licensed rights and patents and 10 years for developed technology and other.
+Added: Completed technology intangible assets are amortized over their estimated useful lives, which range between 1 to 31 years, with a remaining weighted average useful life of 13 years.
In connection with our acquisition of Reata in September 2023 we acquired SKYCLARYS, a commercially-approved product in the U.S., with an estimated fair value of approximately $ 4.2 billion , which includes measurement period adjustments.
+Added: During the first quarter of 2024 SKYCLARYS was approved in the E.U.
+Added: and became commercially available, which resulted in the reclassification of the related intangible asset, with an estimated fair value of approximately $ 2.3 billion, from IPR&D to completed technology.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
IPR&D Related to Business Combinations
1 unchanged sentence
Included in IPR&D balances are adjustments related to foreign currency exchange rate fluctuations.
−Removed: We review amounts capitalized as
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: acquired IPR&D for impairment annually, as of October 31, and whenever events or changes in circumstances indicate to us that the carrying value of the assets might not be recoverable.
+Added: We review amounts capitalized as acquired IPR&D for impairment annually, as of October 31, and whenever events or changes in circumstances indicate to us that the carrying value of the assets might not be recoverable.
+Added: The carrying value associated with our IPR&D assets as of December 31, 2024, relates to the IPR&D programs we acquired in connection with our acquisition of HI-Bio in July 2024, with an estimated fair value of approximately $ 1.6 billion.
The carrying value associated with our IPR&D assets as of December 31, 2023, relates to the IPR&D programs we acquired in connection with our acquisition of Reata in September 2023 with an estimated fair value of approximately $ 2.3 billion , which includes measurement period adjustments.
+Added: During the first quarter of 2024 SKYCLARYS was approved in the E.U.
+Added: and became commercially available, which resulted in the reclassification of the related intangible asset from IPR&D to completed technology.
Priority Review Voucher
−Removed: In connection with our acquisition of Reata in September 2023 we acquired a rare pediatric disease priority review voucher that may be used to obtain priority review by the FDA for a future regulatory submission or sold to a third party.
−Removed: We recorded the priority review voucher based on its estimated fair value of $ 100.0 million as an intangible asset.
−Removed: The estimated fair value was based on recent external purchase and sale transactions of similar vouchers.
−Removed: For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to these consolidated financial statements.
−Removed: In connection with our acquisition of Convergence, we recognized $ 424.6 million of acquired IPR&D intangible assets for vixotrigine.
−Removed: In the periods following our acquisition of vixotrigine, there were numerous delays in the initiation of Phase 3 studies for the potential treatment of TGN and for the potential t reatment of DPN, another form of neuropathic pain.
−Removed: We engaged with the FDA regarding the design of the potential Phase 3 studies of vixotrigine for the potential treatment of TGN and DPN and performed an additional clinical trial of vixotrigine, which was completed during 2022.
−Removed: The performance of this additional clinical trial delayed the initiation of the Phase 3 studies of vixotrigine for the potential treatment of TGN, and, as a result, we recognized an impairment charge of $ 44.3 million related to vixotrigine for the potential treatment of TGN during the first quarter of 2021.
−Removed: During the fourth quarter of 2022 we discontinued further development of vixotrigine based on regulatory, development and commercialization challenges.
−Removed: For the year ended December 31, 2022, we recognized an impairment charge of approximately $ 119.6 million related to vixotrigine for the potential treatment of DPN, reducing the remaining book value of this IPR&D intangible asset to zero.
−Removed: We also adjusted the value of our contingent consideration obligations related to this asset resulting in a pre-tax gain of approximately $ 209.1 million , which was recognized in (gain) loss on fair value remeasurement of contingent consideration within our consolidated statements of income for the year ended December 31, 2022.
−Removed: BIIB111 and BIIB112
−Removed: In connection with our acquisition of Nightstar Therapeutics plc, we recognized $ 480.0 million and $ 220.0 million of acquired IPR&D intangible assets for BIIB111 and BIIB112, respectively.
−Removed: During the second quarter of 2021 we announced that our Phase 3 STAR study of BIIB111 and our Phase 2/3 XIRIUS study of BIIB112 did not meet their primary endpoints.
−Removed: In the third quarter of 2021 we suspended further development on these programs based on the decision by management as part of its strategic review process.
−Removed: For the year ended December 31, 2021, we recognized an impairment charge of $ 365.0 million related to BIIB111 and an impairment charge of $ 220.0 million related to BIIB112, reducing the remaining book values of these IPR&D intangible assets to zero .
−Removed: In addition, as a result of our decision to suspend further development of BIIB111 and BIIB112, we recorded charges of approximately $ 39.1 million during the third quarter of 2021 related to our manufacturing arrangements and other costs that we expect to incur as a result of suspending these programs.
−Removed: These charges were recognized in research and development expense in our consolidated statements of income for the year ended December 31, 2021.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: In connection with our acquisition of Reata in September 2023 we acquired a rare pediatric disease PRV which may be used to obtain priority review by the FDA for a future regulatory submission or sold to a third party .
+Added: We recorded the PRV based on its estimated fair value of $ 100.0 million as an intangible asset.
+Added: The estimated fair value of the PRV was based on recent external purchase and sale transactions of similar vouchers.
+Added: For additional information on our acquisitions of Reata and HI-Bio, please read Note 2, Acquisitions , to these consolidated financial statements.
Estimated Future Amortization of Intangible Assets
4 unchanged sentences
(In millions) 2024 2023
−Removed: Goodwill, beginning of year $ 5,749.0 $ 5,761.1
+Added: Goodwill, January 1 $ 6,219.2 $ 5,749.0
+Added: Goodwill resulting from HI-Bio acquisition 256.5 —
Goodwill resulting from Reata acquisition (1)
Other ( 1.5 ) 5.7
−Removed: Goodwill, end of year $ 6,219.2 $ 5,749.0
−Removed: For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to these consolidated financial statements.
+Added: Goodwill, December 31 $ 6,478.9 $ 6,219.2
+Added: (1) Goodwill resulting from Reata acquisition for the year ended December 31, 2024, relates to Reata measurement period adjustments recognized during 2024.
+Added: For additional information on our acquisitions of Reata and HI-Bio, please read Note 2, Acquisitions , to these consolidated financial statements.
As of December 31, 2024 and 2023, we had no accumulated impairment losses related to goodwill.
4 unchanged sentences
The tables below present information about our assets and liabilities that are regularly measured and carried at fair value and indicate the level within the fair value hierarchy of the valuation techniques we utilized to determine such fair value:
+Added: Fair Value Measurements on a Recurring Basis
As of December 31, 2024
−Removed: (In millions) Total Quoted Prices in
−Removed: Active Markets
−Removed: (Level 1) Significant Other
−Removed: Observable Inputs
+Added: (In millions) Total Quoted Prices
(Level 1) Significant
+Added: Other Observable
+Added: (Level 2) Significant
Cash equivalents $ 1,664.9 $ — $ 1,664.9 $ —
1 unchanged sentence
Other current assets:
−Removed: Receivable from Samsung BioLogics (1)
−Removed: 430.0 — — 430.0
Derivative contracts 62.5 — 62.5 —
2 unchanged sentences
Total $ 1,949.9 $ 179.7 $ 1,770.2 $ —
+Added: Other current liabilities:
Derivative contracts $ 11.7 $ — $ 11.7 $ —
+Added: Contingent consideration obligations 291.2 — — 291.2
+Added: Other non-current liabilities:
+Added: Contingent consideration obligations 221.6 — — 221.6
Total $ 524.5 $ — $ 11.7 $ 512.8
−Removed: (1) Represents the fair value of the current payment due from Samsung BioLogics as a result of the sale of our 49.9 % equity interest in Samsung Bioepis to Samsung BioLogics during the second quarter of 2022, for which we elected the fair value option.
−Removed: For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 3, Dispositions , to these consolidated financial statements.
−Removed: During the third quarter of 2023 we sold all of our marketable debt securities and used the proceeds to partially fund our acquisition of Reata.
−Removed: For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to these consolidated financial statements.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: Fair Value Measurements on a Recurring Basis
As of December 31, 2023
(In millions) Total Quoted Prices
−Removed: in Active Markets
(Level 1) Significant
2 unchanged sentences
Cash equivalents $ 610.7 $ — $ 610.7 $ —
−Removed: Marketable debt securities:
−Removed: Corporate debt securities 1,231.6 — 1,231.6 —
−Removed: Government securities 810.3 — 810.3 —
−Removed: Mortgage and other asset backed securities 137.3 — 137.3 —
Marketable equity securities 416.8 416.8 — —
2 unchanged sentences
430.0 — — 430.0
−Removed: Other non-current assets:
Derivative contracts 11.9 — 11.9 —
+Added: Other non-current assets:
Plan assets for deferred compensation 37.5 — 37.5 —
−Removed: Receivable from Samsung BioLogics (1)
−Removed: 405.4 — — 405.4
Total $ 1,506.9 $ 416.8 $ 660.1 $ 430.0
1 unchanged sentence
Total $ 31.6 $ — $ 31.6 $ —
−Removed: (1) Represents the fair value of the current and non-current payments due from Samsung BioLogics as a result of the sale of our 49.9 % equity interest in Samsung Bioepis to Samsung BioLogics during the second quarter of 2022, for which we elected the fair value option.
+Added: (1) Represents the fair value of the second deferred payment due from Samsung BioLogics as a result of the sale of our 49.9 % equity interest in Samsung Bioepis to Samsung BioLogics during the second quarter of 2022, for which we elected the fair value option.
For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 3, Dispositions , to these consolidated financial statements.
Our marketable equity securities represent investments in publicly traded equity securities.
−Removed: Our ability to liquidate our investments in Denali, Sage and Sangamo may be limited by the size of our interest, the volume of market related activity, our concentrated level of ownership and potential restrictions resulting from our status as a collaborator.
+Added: Our ability to liquidate our investments in Denali and Sage may be limited by the size of our interest, the volume of market related activity, our
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: concentrated level of ownership and potential restrictions resulting from our status as a collaborator.
Therefore, we may realize significantly less than the current value of such investments.
1 unchanged sentence
There have been no material impairments of our assets measured and carried at fair value as of December 31, 2024 and 2023.
−Removed: In addition, there have been no changes in valuation techniques as of December 31, 2023 and 2022.
−Removed: For a description of our validation procedures related to prices provided by third-party pricing services and our option pricing valuation model, please read the Fair Value Measurements section within Note 1, Summary of Significant Accounting Policies, to these consolidated financial statements.
+Added: In addition, there have been no changes to our valuation techniques as of December 31, 2024 and 2023.
+Added: For a description of our validation procedures related to prices provided by third-party pricing services and our option pricing valuation model, please read Note 1, Summary of Significant Accounting Policies - Fair Value Measurements, to these consolidated financial statements.
Level 3 Assets and Liabilities Held at Fair Value
+Added: The following table presents quantitative information, as of the dates indicated, about the valuation techniques and significant unobservable inputs used in the valuation of our Level 3 financial assets and liabilities measured at fair value on a recurring basis:
+Added: Quantitative Information about Level 3 Fair Value Measurements
+Added: As of December 31, 2024
+Added: (In millions) Fair Value Valuation Technique Significant
+Added: Unobservable Input(s) Range Weighted
+Added: Contingent consideration obligations $ 512.8 Discounted cash flow Discount rate 6.2 % - 6.3 %
+Added: Expected timing of achievement of development milestones 2025 - 2030
+Added: The weighted average discount rates were calculated based on the relative fair values of each distinct contingent consideration obligation related to our acquisition of HI-Bio in July 2024.
+Added: In addition, we apply various probabilities of technological and regulatory success to the valuation models to estimate the fair values of these contingent consideration obligations, which ranged from 68.3 % to near certain probability as of December 31, 2024.
There were no transfers of assets or liabilities into or out of Level 3 as of December 31, 2024 and 2023.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Contingent Consideration Obligations
−Removed: In connection with our acquisition of Convergence, we agreed to make additional payments based upon the achievement of certain milestone events.
+Added: In connection with our acquisition of HI-Bio in July 2024 we agreed to make additional payments based upon the achievement of certain milestone events.
The following table provides a roll forward of the fair value of our contingent consideration obligations, which were classified as Level 3 measurements:
−Removed: As of December 31,
−Removed: (In millions) 2022
+Added: (In millions) As of December 31, 2024
Fair value, beginning of year $ —
+Added: Contingent consideration resulting from HI-Bio acquisition 485.1
Changes in fair value 27.7
Fair value, end of year $ 512.8
−Removed: For the year ended December 31, 2022, the changes in fair value of our contingent consideration obligations were primarily due to the discontinuation of further development efforts related to vixotrigine for the potential treatment of TGN and DPN, resulting in a reduction of our contingent consideration obligations of approximatel y $ 195.4 million, reducing the remaining fair value of vixotrigine to zero, as well as changes in the interest rates used to revalue our contingent consideration liabilities.
Changes in the fair values of our contingent consideration obligations are recorded in (gain) loss on fair value remeasurement of contingent consideration in our consolidated statements of income.
1 unchanged sentence
For additional information on the valuation techniques and inputs utilized in the valuation of our financial assets and liabilities, please read Note 1, Summary of Significant Accounting Policies, to these consolidated financial statements.
−Removed: Convergence Pharmaceuticals Holdings Limited
−Removed: In connection with our acquisition of Convergence in February 2015 we recorded a contingent consideration obligation of $ 274.5 million.
−Removed: As of December 31, 2021, the fair value of this contingent consideration obligation was $ 209.1 million.
−Removed: During the fourth quarter of 2022 we discontinued further development of vixotrigine based on regulatory, development and commercialization challenges.
−Removed: As a result, the fair value of the contingent consideration obligations related to Convergence has been adjusted to zero , resulting in a pre-tax gain of approximately $ 209.1 million for the year ended December 31, 2022.
−Removed: This pre-tax gain was recorded in (gain) loss on fair value remeasurement of contingent consideration within our consolidated statements of income.
−Removed: Nonrecurring Fair Value Measurements
−Removed: For the year ended December 31, 2022, we recorded impairment charges of $ 119.6 million related to vixotrigine.
−Removed: As a result, the remaining book values associated with these programs were reduced to zero.
−Removed: For the year ended December 31, 2021, we recorded impairment charges of $ 365.0 million related to BIIB111 and $ 220.0 million related to BIIB112.
−Removed: As a result, the remaining book values associated with these programs were reduced to zero .
−Removed: For additional information on our impairments for intangible assets, please read Note 7, Intangible Assets and Goodwill , to these consolidated financial statements.
+Added: As of December 31, 2024, approximately $ 291.2 million of the fair value of the total contingent consideration obligation was classified as short-term and reflected as a component of accrued expense and other within our consolidated balance sheets with the remaining $ 221.6 million reflected as a component of other long-term liabilities in our consolidated balance sheets.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: For the year ended December 31, 2024, the changes in the fair value of our contingent consideration obligations were primarily due to changes in interest rates used to revalue our contingent consideration liabilities, the passage of time and updates to the expected timing of achieving certain milestones which will trigger contingent consideration payments.
Financial Instruments Not Carried at Fair Value
1 unchanged sentence
Due to the short-term nature of certain financial instruments, the carrying value reflected in our consolidated balance sheets for current accounts receivable, due from anti-CD20 therapeutic programs, other current assets, accounts payable and accrued expense and other, approximates fair value.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Debt Instruments
4 unchanged sentences
2023 Term Loan 364-day tranche $ — $ 150.0
+Added: 4.050 % Senior Notes due September 15, 2025
Current portion of notes payable and term loan 1,741.0 150.0
2 unchanged sentences
4.050 % Senior Notes due September 15, 2025
−Removed: 1,721.5 1,699.9
2.250 % Senior Notes due May 1, 2030
8 unchanged sentences
In connection with our acquisition of Reata we drew $ 1.0 billion from our 2023 Term Loan, comprised of a $ 500.0 million floating rate 364-day tranche and a $ 500.0 million floating rate three-year tranche.
+Added: As of December 31, 2024, our 2023 Term Loan was repaid in full.
For additional information on our 2023 Term Loan, please read Note 13, Indebtedness , to these consolidated financial statements.
4 unchanged sentences
Financial Instruments
−Removed: T he following table summarizes our financial assets with maturities of less than 90 days from the date of purchase included in cash and cash equivalents in our consolidated balance sheets:
+Added: The following table summarizes our financial assets with maturities of less than 90 days from the date of purchase included in cash and cash equivalents in our consolidated balance sheets:
As of December 31,
(In millions) 2024 2023
−Removed: Commercial paper $ — $ 177.2
−Removed: Overnight reverse repurchase agreements — 59.0
Money market funds $ 1,664.9 $ 610.7
−Removed: Short-term debt securities — 29.9
Total $ 1,664.9 $ 610.7
−Removed: The carrying values of our commercial paper, including accrued interest, overnight reverse repurchase agreements, money market funds and short-term debt securities approximate fair value due to their short-term maturities.
−Removed: We partially funded our Reata acquisition through available cash, cash equivalents and marketable securities.
−Removed: As of December 31, 2023, we have sold all of our marketable debt securities.
−Removed: For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to these consolidated financial statements.
+Added: The carrying value of our money market funds approximates fair value due to their short-term maturities.
AND SUBSIDIARIES
1 unchanged sentence
Our marketable equity securities gains (losses) are recorded in other (income) expense, net in our consolidated statements of income.
−Removed: The following tables summarize our marketable debt and equity securities, classified as available for sale:
+Added: The following tables summarize our available-for-sale marketable equity securities:
As of December 31, 2024
1 unchanged sentence
Marketable equity securities:
−Removed: Marketable equity securities, current $ 31.6 $ — $ ( 21.0 ) $ 10.6
Marketable equity securities, non-current $ 668.7 $ — $ ( 489.0 ) $ 179.7
2 unchanged sentences
(In millions) Amortized
−Removed: Marketable debt securities:
−Removed: Corporate debt securities:
−Removed: Current $ 936.2 $ — $ ( 4.9 ) $ 931.3
−Removed: Non-current 305.3 0.1 ( 5.1 ) 300.3
−Removed: Government securities:
−Removed: Current 547.1 0.1 ( 5.0 ) 542.2
−Removed: Non-current 271.4 — ( 3.3 ) 268.1
−Removed: Mortgage and other asset backed securities:
−Removed: Current — — — —
−Removed: Non-current 139.1 0.1 ( 1.9 ) 137.3
−Removed: Total marketable debt securities $ 2,199.1 $ 0.3 $ ( 20.2 ) $ 2,179.2
Marketable equity securities:
+Added: Marketable equity securities, current $ 31.6 $ — $ ( 21.0 ) $ 10.6
Marketable equity securities, non-current 948.3 — ( 542.1 ) 406.2
Total marketable equity securities $ 979.9 $ — $ ( 563.1 ) $ 416.8
−Removed: Summary of Contractual Maturities:
−Removed: Available-for-Sale Debt Securities
−Removed: The estimated fair value and amortized cost of our marketable debt securities classified as available-for-sale by contractual maturity are summarized as follows:
−Removed: As of December 31, 2022
−Removed: (In millions) Estimated
−Removed: Fair Value Amortized
−Removed: Due in one year or less $ 1,473.5 $ 1,483.3
−Removed: Due after one year through five years 694.4 703.7
−Removed: Due after five years 11.3 12.1
−Removed: Total marketable debt securities $ 2,179.2 $ 2,199.1
−Removed: The average maturity of our marketable debt securities classified as available-for-sale as of December 31, 2022, was approximately 8 months.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Proceeds from Marketable Debt Securities
5 unchanged sentences
Realized losses 18.4 12.6
+Added: We partially funded our Reata acquisition through available cash, cash equivalents and marketable securities.
+Added: As of December 31, 2023, we had sold all of our marketable debt securities.
+Added: For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to these consolidated financial statements.
Realized losses for the year ended December 31, 2023, primarily relate to sales of U.S.
treasuries and corporate bonds.
−Removed: Realized losses for the years ended December 31, 2022 and 2021, primarily relate to sales of corporate bonds, agency mortgage-backed securities and other asset-backed securities.
−Removed: During the third quarter of 2023 we sold all of our marketable debt securities and used the proceeds to partially fund our acquisition of Reata.
−Removed: For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to these consolidated financial statements.
+Added: Realized losses for the year ended December 31, 2022, primarily relate to sales of corporate bonds, agency mortgage-backed securities and other asset-backed securities.
Strategic Investments
Our strategic investment portfolio includes investments in equity securities of certain biotechnology companies, which are reflected within our disclosures included in Note 8, Fair Value Measurements , to these consolidated financial statements, as well as venture capital funds where the underlying investments are in equity securities of certain biotechnology companies and non-marketable equity securities.
+Added: As of December 31, 2024, our strategic investment portfolio was comprised of investments totaling $ 226.7 million which are included in investments and other assets in our consolidated balance sheets.
As of December 31, 2023, our strategic investment portfolio was comprised of investments totaling $ 460.7 million which are included in other current assets and investments and other assets in our consolidated balance sheets.
−Removed: As of December 31, 2022, our strategic investment portfolio comprised of investments totaling $ 846.0 million which are included in investments and other assets in our consolidated balance sheets.
−Removed: The decrease in our strategic investment portfolio for the year ended December 31, 2023, was primarily due to the decrease in the fair value of our investments in Denali, Sangamo and Sage common stock.
−Removed: Additionally, during 2023 we sold a portion of our Sangamo and Denali common stock and the remainder of our Ionis common stock.
−Removed: For additional information on our investments in Denali, Sangamo, Sage and Ionis common stock, please read Note 19, Collaborative and Other Relationships , to these consolidated financial statements.
+Added: The decrease in our strategic investment portfolio for the year ended December 31, 2024, was primarily due to the decrease in the fair value of our investment in Sage common stock, partially offset by an increase in the fair value of our investment in Denali common stock.
+Added: Additionally, during 2024 we sold a portion of our Denali common stock and the remaining portion of our Sangamo common stock.
+Added: For additional information on our investments in Denali, Sangamo and Sage common stock, please read Note 19, Collaborative and Other Relationships , to these consolidated financial statements.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Derivative Instruments
8 unchanged sentences
We recognize all cash flow hedge reclassifications from AOCI and fair value changes of excluded portions in the same line item in our consolidated statements of income that have been impacted by the hedged item.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The notional amount of foreign currency forward contracts and foreign currency options that were entered into to hedge forecasted revenue and operating expense is summarized as follows:
4 unchanged sentences
British pound 133.8 —
−Removed: Swiss franc — —
Canadian dollar 38.6 —
6 unchanged sentences
Net unrealized gains (losses) $ 50.3 $ ( 34.8 ) $ 8.6
−Removed: We expect the net unrealized losses of approximately $ 34.8 million to be settled over the next 12 months, with any amounts in AOCI to be reported as an adjustment to revenue or operating expense.
+Added: We expect the net unrealized gains of approximately $ 50.3 million to be settled over the next 12 months, with any amounts in AOCI to be reported as an adjustment to revenue or operating expense.
We consider the impact of our and our counterparties’ credit risk on the fair value of the contracts as well as the ability of each party to execute its contractual obligations.
4 unchanged sentences
Reclassified from AOCI into Operating Income (in millions)
−Removed: Net Gains/(Losses)
+Added: Net Gains/(Losses) Excluded from Effectiveness Testing and
Recognized in Operating Income (in millions)
2 unchanged sentences
Operating expense ( 12.9 ) 3.7 ( 5.5 ) Operating expense — — —
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Net Investment Hedges - Hedging Instruments
In February 2012 we entered into a joint venture agreement with Samsung BioLogics establishing an entity, Samsung Bioepis, to develop, manufacture and market biosimilar products.
−Removed: In June 2018 we exercised our option under our joint venture agreement to increase our ownership percentage in Samsung Bioepis from approximately 5.0 % to approximately 49.9 %.
Our investment in the equity of Samsung Bioepis related to this transaction was exposed to the currency fluctuations in the South Korean won.
5 unchanged sentences
For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 3, Dispositions , to these consolidated financial statements.
−Removed: Prior to the sale of our 49.9 % equity interest in Samsung Bioepis, we recognized changes in the spot exchange rate of these foreign currency forward contracts in AOCI.
−Removed: The pre-tax portion of the fair value of these foreign currency forward contracts that were included in AOCI in total equity reflected net gains of $ 10.6 million as of December 31, 2021.
−Removed: We excluded fair value changes related to the forward rate from our hedging relationship and amortized the
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: forward points in other (income) expense, net in our consolidated statements of income over the term of the contract.
−Removed: The pre-tax portion of the fair value of the forward points that were included in AOCI in total equity reflected net losses of $ 3.6 million as of December 31, 2021.
The following table summarizes the effect of our net investment hedges in our consolidated financial statements:
−Removed: For the Years Ended December 31,
+Added: For the Year Ended December 31, 2022
Net Gains/(Losses)
7 unchanged sentences
$ ( 3.2 ) Other (income) expense (1)
−Removed: $ ( 4.6 ) $ ( 0.6 )
(1) Beginning in the second quarter of 2022 we no longer held net investment hedges as they were closed with the sale of our 49.9 % equity interest in Samsung Bioepis in April 2022.
5 unchanged sentences
The aggregate notional amount of these outstanding foreign currency forward contracts was $ 738.7 million and $ 1,301.5 million as of December 31, 2024 and 2023, respectively.
−Removed: Net gains of $ 3.8 million, net losses of $ 34.7 million and net losses of $ 43.3 million related to these contracts were recorded as a component of other (income) expense, net for the years ended December 31, 2023, 2022 and 2021, respectively.
+Added: Net losses of $ 49.7 million, net gains of $ 3.8 million and net losses of $ 34.7 million related to these contracts were recorded as a component of other (income) expense, net for the years ended December 31, 2024, 2023 and 2022, respectively.
Summary of Derivative Instruments
32 unchanged sentences
This facility includes 393,000 square feet related to a large-scale biologics manufacturing facility, 290,000 square feet of warehouse, utilities and support space and 51,000 square feet of administrative space.
−Removed: As of December 31, 2023 and 2022, we had approximately $ 728.8 million and $ 711.1 million, respectively, capitalized as construction in progress related to this facility.
−Removed: In the second quarter of 2021 a portion of this facility (the first manufacturing suite) received a GMP multi-product license from the SWISSMEDIC, resulting in approximately $ 1.2 billion of fixed assets being placed into service during the second quarter of 2021.
−Removed: The second manufacturing suite became operational in January 2024, resulting in approximately $ 710.7 million of fixed assets being placed into service during the first quarter of 2024.
−Removed: Solothurn has been approved for the manufacture of ADUHELM and LEQEMBI by the FDA.
+Added: As of December 31, 2023, we had approximately $ 728.8 million capitalized as construction in progress related to this facility.
+Added: In the second quarter of 2021 a portion of this facility (the first manufacturing suite) received a GMP multi-product license from SWISSMEDIC and was placed into service.
+Added: The second manufacturing suite, which was also licensed to operate by SWISSMEDIC, became operational in the first quarter of 2024, resulting in approximately $ 717.3 million of fixed assets being placed into service.
+Added: Solothurn has been approved for the manufacture of LEQEMBI.
125 Broadway Building Sale
In September 2022 we completed the sale of our building and land parcel located at 125 Broadway for an aggregate sales price of approximately $ 603.0 million, which is inclusive of a $ 10.8 million tenant allowance.
−Removed: This sale resulted in a pre-tax gain on sale of approximately $ 503.7 million, net of transaction costs, which is reflected within gain on sale of building in our consolidated statements of income for the year ended December 31, 2022.
+Added: This sale resulted in a pre-tax gain on sale of approximately $ 503.7 million, net of transaction costs, which is reflected within gain on sale of building, net in our consolidated statements of income for the year ended December 31, 2022.
This transaction included approximately $ 79.2 million of property, plant and equipment, net, which comprised of approximately $ 72.6 million for buildings, approximately $ 1.6 million for land and approximately $ 5.0 million for machinery and equipment.
We lease real estate, including laboratory and office space, and certain equipment.
−Removed: Our leases have remaining lease terms ranging from less than one year to fifteen years .
−Removed: Certain leases include one or more options to renew, exercised at our sole discretion, with renewal terms that can extend the lease term from one year to ten years .
+Added: Our leases have remaining lease terms ranging from less than one year to fourteen years .
+Added: Certain leases include one or more options to renew, exercised at our sole discretion, with renewal terms that can extend the lease term from less than one year to ten years .
In addition, we sublease certain real estate to third parties.
−Removed: Our sublease portfolio consists of operating leases, with remaining lease terms ranging from one year to six years .
+Added: Our sublease portfolio consists of operating leases, with remaining lease terms ranging from less than one year to five years .
AND SUBSIDIARIES
38 unchanged sentences
6100 Legacy Drive Lease
−Removed: In connection with our acquisition of Reata we assumed responsibility for a single-tenant, build-to-suit building of approximately 327,400 square feet of office and laboratory space located in Plano, Texas, with an initial lease term of 16 years.
+Added: In connection with our acquisition of Reata in September 2023 we assumed responsibility for a single-tenant, build-to-suit building of approximately 327,400 square feet of office and laboratory space located in Plano, Texas, with an initial lease term of 16 years.
We recorded a lease liability of approximately $ 151.8 million, which represents the net present value of rental expense over the remaining lease term of approximately 15 years, with a corresponding right-of-use asset of approximately $ 121.2 million, which represents our estimate of the fair value for a market participant of the current rental market in the Dallas, Texas area.
10 unchanged sentences
The transaction was treated as a lease modification as of the effective date and resulted in the derecognition of a right-of-use asset of approximately $ 47.4 million and a lease liability of approximately $ 52.7 million, which resulted in a gain of approximately $ 5.3 million, which was recorded within restructuring charges in our consolidated statements of income for the year ended December 31, 2022.
+Added: As of December 31, 2024, we no longer lease any portion of this space.
AND SUBSIDIARIES
5 unchanged sentences
2023 Term Loan 364-day tranche $ — $ 150.0
+Added: 4.050 % Senior Notes due September 15, 2025
Current portion of notes payable and term loan $ 1,748.6 $ 150.0
2 unchanged sentences
4.050 % Senior Notes due September 15, 2025
−Removed: 1,746.6 1,744.7
2.250 % Senior Notes due May 1, 2030
7 unchanged sentences
In connection with our acquisition of Reata we drew $ 1.0 billion from our 2023 Term Loan, comprised of a $ 500.0 million floating rate 364-day tranche and a $ 500.0 million floating rate three-year tranche.
+Added: As of December 31, 2024, our 2023 Term Loan was repaid in full.
As of December 31, 2024, we were in compliance with our senior note covenants and term loan covenants.
2023 Term Loan Credit Agreement
−Removed: In connection with our acquisition of Reata in September 2023 we entered into a $ 1.5 billion term loan credit agreement (2023 Term Loan).
+Added: In connection with our acquisition of Reata in September 2023 we entered into a $ 1.5 billion term loan credit agreement.
On the closing date of the Reata acquisition we drew $ 1.0 billion from the 2023 Term Loan, comprised of a $ 500.0 million floating rate 364-day tranche and a $ 500.0 million floating rate three-year tranche.
The remaining unused commitment of $ 500.0 million was terminated.
−Removed: During the fourth quarter of 2023 we repaid $ 350.0 million of the 364-day tranche.
−Removed: As of December 31, 2023, we had $ 650.0 million outstanding under the 2023 Term Loan, of which $ 150.0 million was outstanding under the 364-day tranche and $ 500.0 million was outstanding under the three-year tranche.
−Removed: 2021 Exchange Offer
−Removed: In February 2021 we completed our private offer to exchange (Exchange Offer) our tendered 5.200 % Senior Notes due September 15, 2045 (2045 Senior Notes) for a new series of 3.250 % Senior Notes due February 15, 2051 (2051 Senior Notes) and cash, and an offer to purchase our tendered 2045 Senior Notes for cash.
−Removed: An aggregate principal amount of approximately $ 624.6 million of our 2045 Senior Notes was exchanged for an aggregate principal amount of approximately $ 700.7 million of our 2051 Senior Notes and aggregate cash payments of approximately $ 151.8 million.
−Removed: Our Exchange Offer has been accounted for as a debt modification;
−Removed: as such, the cash component has been reflected as additional debt discount and is amortized as an adjustment to interest expense over the term of our 2051 Senior Notes.
−Removed: In addition, we redeemed an aggregate principal amount of approximately $ 8.9 million of our 2045 Senior Notes for aggregate cash payments of approximately $ 12.1 million, excluding accrued and unpaid interest.
−Removed: The redemption has been accounted for as a debt extinguishment;
−Removed: as such, we recognized a pre-tax charge of $ 3.2 million upon the extinguishment of such 2045 Senior Notes.
−Removed: This charge, which was recognized in interest expense in other (income) expense, net in our consolidated statements of income for the year ended December 31, 2021, reflects the payment of an early call premium and the write-off of the remaining unamortized original debt issuance costs and discount balances associated with such 2045 Senior Notes.
+Added: As of December 31, 2023, we repaid $ 350.0 million of the 364-day tranche.
+Added: The remaining $ 150.0 million portion of the 364-day tranche was repaid during the first quarter of 2024.
+Added: Additionally, during the first quarter of 2024 we repaid $ 250.0 million of the three-year tranche, with the remaining $ 250.0 million portion being subsequently repaid in full during the second quarter of 2024.
+Added: For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to these consolidated financial statements.
+Added: 2021 Exchange Offer Senior Notes
+Added: The following is a summary of our currently outstanding senior unsecured notes issued in 2021 as part of our Exchange Offer (the 2021 Exchange Offer Senior Notes), consisting of the following:
+Added: • $ 700.7 million aggregate principal amount of 3.25 % Senior Notes due February 15, 2051, valued at 99.298 % of par.
+Added: Our 2021 Exchange Offer Senior Notes are senior unsecured obligations and may be redeemed at our option at any time at 100.0 % of the principal amount plus accrued interest and a specified make-whole amount.
+Added: Our 2021 Exchange Offer Senior Notes contain a change of control provision that may require us to purchase the notes at a price equal to 101.0 % of the principal amount plus accrued and unpaid interest to the date of purchase under certain circumstances.
+Added: The costs associated with this exchange offer of approximately $ 5.4 million have been recorded as a reduction to the carrying amount of the debt in our consolidated balance sheets.
+Added: These costs along with the discounts will be amortized as additional interest expense using the effective interest rate method over the period from issuance through maturity.
+Added: Interest on our 2021 Exchange Offer Senior Notes is payable February 15 and August 15 of each year, commencing August 15, 2021.
AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: Upon settlement, we also made aggregate cash payments of approximately $ 13.8 million to settle all accrued and unpaid interest from the last interest payment date on our 2045 Senior Notes that were exchanged or redeemed.
−Removed: We incurred approximately $ 6.1 million of costs associated with our Exchange Offer, which was recognized in interest expense in other (income) expense, net in our consolidated statements of income for the year ended December 31, 2021.
2020 Senior Notes
−Removed: On April 30, 2020, we issued senior unsecured notes for an aggregate principal amount of $ 3.0 billion (2020 Senior Notes), consisting of the following:
+Added: The following is a summary of our currently outstanding senior unsecured notes issued in 2020 (2020 Senior Notes), consisting of the following:
• $ 1.5 billion aggregate principal amount of 2.25 % Senior Notes due May 1, 2030, valued at 99.973 % of par;
11 unchanged sentences
Our 2015 Senior Notes contain a change of control provision that may require us to purchase the notes at a price equal to 101.0 % of the principal amount plus accrued and unpaid interest to the date of purchase under certain circumstances.
−Removed: The original costs associated with this offering of approximately $ 47.5 million have been recorded as a reduction to the carrying amount of the debt in our consolidated balance sheets.
+Added: The original costs associated with this offering of approximately $ 47.5 million, of which approximately $ 23.6 million pertains to our currently outstanding notes, have been recorded as a reduction to the carrying amount of the debt in our consolidated balance sheets.
These costs along with the discounts will be amortized as additional interest expense using the effective interest rate method over the period from issuance through maturity.
+Added: Interest on our 2015 Senior Notes is payable March 15 and September 15 of each year, commencing March 15, 2016.
3.625 % Senior Notes due September 15, 2022
4 unchanged sentences
2024 Revolving Credit Facility
−Removed: In January 2020 we entered into a $ 1.0 billion, five-year senior unsecured revolving credit facility under which we are permitted to draw funds for working capital and general corporate purposes.
−Removed: The terms of the revolving credit facility
+Added: In August 2024 we entered into a $ 1.5 billion, five-year senior unsecured revolving credit facility under which we are permitted to draw funds for working capital and general corporate purposes.
+Added: The terms of the revolving credit facility include a financial covenant that requires us not to exceed a maximum consolidated leverage ratio.
+Added: This revolving credit facility replaced the revolving credit facility that we entered into in January 2020.
+Added: As of December 31, 2024, we had no outstanding borrowings and were in compliance with all covenants under this facility.
AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: include a financial covenant that requires us not to exceed a maximum consolidated leverage ratio.
−Removed: As of December 31, 2023, we had no outstanding borrowings and were in compliance with all covenants under this facility.
Debt Maturity
1 unchanged sentence
(In millions) As of December 31, 2024
+Added: 2025 $ 1,750.0
2030 and thereafter 4,817.3
15 unchanged sentences
Our 2020 Share Repurchase Program does not have an expiration date.
−Removed: All share repurchases under our 2020 Share Repurc hase Program will be retired.
−Removed: Under our 2020 Share Repurchase Program, we repurchased and retired approximately 3.6 million and 6.0 million shares of our common stock at a cost of approximately $ 750.0 million and $ 1.8 billion during the years ended December 31, 2022 and 2021 , respectively.
−Removed: There were no share repurchases of our common stock during the year ended December 31, 2023.
+Added: All shares repurchased under our 2020 Share Repurc hase Program were retired.
+Added: Under our 2020 Share Repurchase Program, we repurchased and retired approximately 3.6 million shares of our common stock at a cost of approximately $ 750.0 million during the year ended December 31, 2022 .
+Added: There were no share repurchases of our common stock during the years ended December 31, 2024 and 2023.
Approximately $ 2.1 billion remained available under our 2020 Share Repurchase Program as of December 31, 2024.
2 unchanged sentences
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: In August 2022 the IRA was signed into law.
−Removed: Among other things, the IRA levies a 1.0% excise tax on net stock repurchases after December 31, 2022.
−Removed: While we have historically made discretionary share repurchases, we had no share repurchases of our common stock during the year ended December 31, 2023.
Accumulated Other Comprehensive Income (Loss)
1 unchanged sentence
December 31, 2024
−Removed: (In millions) Unrealized Gains (Losses) on Securities Available for Sale, Net of Tax Unrealized Gains (Losses) on Cash Flow Hedges, Net of Tax Unrealized Gains (Losses) on Pension Benefit Obligation, Net of Tax Currency Translation Adjustments Total
+Added: (In millions) Unrealized Gains (Losses) on Cash Flow Hedges,
+Added: Net of Tax Unrealized Gains (Losses) on Pension Benefit Obligation,
+Added: Net of Tax Currency
+Added: Net of Tax Total
Balance, December 31, 2023 $ ( 25.0 ) $ ( 2.6 ) $ ( 126.1 ) $ ( 153.7 )
4 unchanged sentences
December 31, 2023
−Removed: (In millions) Unrealized Gains (Losses) on Securities Available for Sale, Net of Tax Unrealized Gains (Losses) on Cash Flow Hedges, Net of Tax Gains (Losses) on Net Investment Hedges, Net of Tax (1)
−Removed: Unrealized Gains (Losses) on Pension Benefit Obligation, Net of Tax Currency Translation Adjustments Total
+Added: (In millions) Unrealized Gains (Losses) on Securities Available for Sale, Net of Tax Unrealized Gains (Losses) on Cash Flow Hedges,
+Added: Net of Tax Unrealized Gains (Losses) on Pension Benefit Obligation,
+Added: Net of Tax Currency Translation Adjustments,
+Added: Net of Tax Total
Balance, December 31, 2022 $ ( 15.7 ) $ 15.1 $ ( 1.1 ) $ ( 163.2 ) $ ( 164.9 )
3 unchanged sentences
Balance, December 31, 2023 $ — $ ( 25.0 ) $ ( 2.6 ) $ ( 126.1 ) $ ( 153.7 )
−Removed: (1) Beginning in the second quarter of 2022 we no longer held net investment hedges as they were closed with the sale of our 49.9 % equity interest in Samsung Bioepis in April 2022.
−Removed: For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 3, Dispositions , to these consolidated financial statements.
December 31, 2022
−Removed: (In millions) Unrealized Gains (Losses) on Securities Available for Sale, Net of Tax Unrealized Gains (Losses) on Cash Flow Hedges, Net of Tax Gains (Losses) on Net Investment Hedges, Net of Tax Unrealized Gains (Losses) on Pension Benefit Obligation, Net of Tax Currency Translation Adjustments Total
+Added: (In millions) Unrealized Gains (Losses) on Securities Available for Sale,
+Added: Net of Tax Unrealized Gains (Losses) on Cash Flow Hedges,
+Added: Net of Tax Gains (Losses) on Net Investment Hedges,
+Added: Net of Tax (1)
+Added: Unrealized Gains (Losses) on Pension Benefit Obligation,
+Added: Net of Tax Currency Translation Adjustments,
+Added: Net of Tax Total
Balance, December 31, 2021 $ ( 2.2 ) $ 53.8 $ 25.5 $ ( 44.8 ) $ ( 139.0 ) $ ( 106.7 )
3 unchanged sentences
Balance, December 31, 2022 $ ( 15.7 ) $ 15.1 $ — $ ( 1.1 ) $ ( 163.2 ) $ ( 164.9 )
+Added: (1) Beginning in the second quarter of 2022 we no longer held net investment hedges as they were closed with the sale of our 49.9 % equity interest in Samsung Bioepis in April 2022.
+Added: For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 3, Dispositions , to these consolidated financial statements.
AND SUBSIDIARIES
4 unchanged sentences
2024 2023 2022
−Removed: Gains (losses) on securities available for sale $ ( 17.0 ) $ ( 12.6 ) $ ( 3.8 ) Other (income) expense
+Added: Gains (losses) on securities available for sale $ — $ ( 17.0 ) $ ( 12.6 ) Other (income) expense, net
— 3.6 2.6 Income tax (benefit) expense
1 unchanged sentence
( 12.9 ) 3.7 ( 5.5 ) Operating expense
−Removed: ( 0.3 ) ( 0.3 ) 0.2 Other (income) expense
+Added: ( 0.4 ) ( 0.3 ) ( 0.3 ) Other (income) expense, net
( 0.6 ) ( 1.7 ) ( 19.8 ) Income tax (benefit) expense
Gains (losses) on net investment hedges (1)
−Removed: — 38.1 ( 0.6 ) Other (income) expense
−Removed: Currency translation adjustments — ( 58.9 ) — Other (income) expense
+Added: — — 38.1 Other (income) expense, net
+Added: Currency translation adjustments — — ( 58.9 ) Other (income) expense, net
Total reclassifications, net of tax $ 4.2 $ ( 0.1 ) $ 145.2
15 unchanged sentences
Amounts excluded from the calculation of net income per diluted share because their effects were anti-dilutive were insignificant.
−Removed: Earnings per share for the years ended December 31, 2022 and 2021, reflects the repurchase of approximately 3.6 million shares and 6.0 million shares of our common stock, respectively, under our share repurchase programs.
−Removed: There were no share repurchases of our common stock during the year ended December 31, 2023.
−Removed: For additional information on our share repurchase programs, please read Note 14, Equity , to these consolidated financial statements.
+Added: Earnings per share for the year ended December 31, 2022, reflects the repurchase of approximately 3.6 million shares of our common stock, respectively, under our 2020 Share Repurchase Program.
+Added: There were no share repurchases of our common stock during the years ended December 31, 2024 and 2023.
+Added: For additional information on our 2020 Share Repurchase Program, please read Note 14, Equity , to these consolidated financial statements.
AND SUBSIDIARIES
14 unchanged sentences
In connection with our acquisition of Reata in September 2023 we recognized Reata equity-based compensation expense, inclusive of employer taxes, of approximately $ 393.4 million attributable to the post-acquisition service period, of which $ 196.4 million was recognized as a charge to selling, general and administrative expense with the remaining $ 197.0 million as a charge to research and development expense within our consolidated statements of income for the year ended December 31, 2023.
−Removed: T hese amounts were associated with the accelerated vesting of stock options and RSUs previously granted to Reata employees that required no future services to vest.
−Removed: For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to these consolidated financial statements.
+Added: These amounts were associated with the accelerated vesting of stock options and RSUs previously granted to Reata employees that required no future services to vest.
+Added: In connection with our acquisition of HI-Bio in July 2024 we recognized HI-Bio equity-based compensation expense, inclusive of employer taxes, of approximately $ 56.4 million attributable to the post-acquisition service period, of which $ 42.5 million was recognized as a charge to research and development expense with the remaining $ 13.9 million as a charge to selling, general and administrative expense within our consolidated statements of income for the year ended December 31, 2024.
+Added: These amounts were associated with the accelerated vesting of stock options and RSUs previously granted to HI-Bio employees and required no future services to vest.
+Added: For additional information on our acquisitions of HI-Bio and Reata, please read Note 2, Acquisitions , to these consolidated financial statements.
The following table summarizes share-based compensation expense associated with each of our share-based compensation programs:
1 unchanged sentence
(In millions) 2024 2023 2022
−Removed: Market stock units $ 4.9 $ 13.2 $ 45.6
Time-vested restricted stock units $ 236.4 $ 220.0 $ 202.3
3 unchanged sentences
Stock options 3.7 3.7 0.3
+Added: Market stock units 0.6 4.9 13.2
Reata equity awards (1)
+Added: HI-Bio equity awards (1)
Subtotal 352.7 668.4 273.6
1 unchanged sentence
Share-based compensation expense included in total cost and expense $ 342.4 $ 658.2 $ 264.3
−Removed: (1) Relates to the Reata equity-based compensation expense attributable to the post-acquisition service period, associated with the accelerated vesting of stock options and RSUs previously granted to Reata employees that required no future services to vest.
−Removed: For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to these consolidated financial statements.
−Removed: As of December 31, 2023, unrecognized compensation cost related to unvested share-based compensation was approximately $ 287.4 million, net of estimated forfeitures.
−Removed: We expect to recognize the cost of these unvested awards over a weighted-average period of 1.8 years.
+Added: (1) Relates to the Reata and HI-Bio equity-based compensation expense attributable to the post-acquisition service period, associated with the accelerated vesting of stock options and RSUs previously granted to Reata and HI-Bio employees that required no future services to vest.
+Added: For additional information on our acquisitions of Reata and HI-Bio, please read Note 2, Acquisitions , to these consolidated financial statements.
AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: As of December 31, 2024, unrecognized compensation cost related to unvested share-based compensation was approximately $ 292.2 million, net of estimated forfeitures.
+Added: We expect to recognize the cost of these unvested awards over a weighted-average period of 1.8 years.
Share-Based Compensation Plans
−Removed: We have three share-based compensation plans pursuant to which awards are currently being made:
+Added: We have two share-based compensation plans pursuant to which awards are currently being made:
(i) the Biogen Inc.
+Added: 2024 Omnibus Equity Plan (2024 Omnibus Equity Plan);
+Added: and (ii) the Biogen Inc.
+Added: 2024 Employee Stock Purchase Plan (2024 ESPP).
+Added: We have three share-based compensation plans pursuant to which outstanding awards have been made, but from which no further awards can or will be made:
+Added: (i) the Biogen Inc.
2006 Non-Employee Directors Equity Plan (2006 Directors Plan);
3 unchanged sentences
2015 Employee Stock Purchase Plan (2015 ESPP).
−Removed: Directors Plan
−Removed: In May 2006 our shareholders approved the 2006 Directors Plan for share-based awards to our directors.
−Removed: Awards granted from the 2006 Directors Plan may include stock options, shares of restricted stock, RSUs, stock appreciation rights and other awards in such amounts and with such terms and conditions as may be determined by a committee of our Board of Directors, subject to the provisions of the 2006 Directors Plan.
−Removed: We have reserved a total of 1.6 million shares of common stock for issuance under the 2006 Directors Plan.
−Removed: The 2006 Directors Plan provides that awards other than stock options and stock appreciation rights will be counted against the total number of shares reserved under the plan in a 1.5 -to-1 ratio.
−Removed: In June 2015 our shareholders approved an amendment to extend the term of the 2006 Directors Plan until June 2025.
−Removed: In June 2017 our shareholders approved the 2017 Omnibus Equity Plan for share-based awards to our employees.
−Removed: Awards granted from the 2017 Omnibus Equity Plan may include stock options, shares of restricted stock, RSUs, performance shares, stock appreciation rights and other awards in such amounts and with such terms and conditions as may be determined by a committee of our Board of Directors, subject to the provisions of the 2017 Omnibus Equity Plan.
−Removed: Shares of common stock available for grant under the 2017 Omnibus Equity Plan consist of 8.0 million shares reserved for this purpose, plus shares of common stock that remained available for grant under the Biogen Idec Inc.
−Removed: 2008 Omnibus Equity Plan (2008 Omnibus Equity Plan) as of June 7, 2017, or that could again become available for grant if outstanding awards under the 2008 Omnibus Equity Plan as of June 7, 2017, are cancelled, surrendered or terminated in whole or in part.
+Added: 2024 Omnibus Equity Plan
+Added: In June 2024 our shareholders approved the 2024 Omnibus Equity Plan for share-based awards to our prospective and current employees, non-employee directors, officers or consultants.
+Added: Awards granted from the 2024 Omnibus Equity Plan may include stock options, shares of restricted stock, restricted stock units, performance shares, stock appreciation rights and other awards in such amounts and with such terms and conditions as may be determined by a committee of our Board of Directors, subject to the provisions of the plan.
+Added: Shares of common stock available for grant under the 2024 Omnibus Equity Plan consist of 3.7 million shares reserved for this purpose, plus shares of common stock that remained available for grant under our 2017 Omnibus Equity Plan (including shares available by reason of a predecessor plan) on the date that our shareholders approved the 2024 Omnibus Equity Plan, plus shares that were subject to awards under the 2017 Omnibus Equity Plan (including shares available by reason of a predecessor plan) that remain unissued upon the cancellation, surrender, exchange, termination or forfeiture of such awards.
The 2024 Omnibus Equity Plan provides that awards other than stock options and stock appreciation rights will be counted against the total number of shares available under the plan in a 1.5 -to-1 ratio.
−Removed: We have not made any awards pursuant to the 2008 Omnibus Equity Plan since our shareholders approved the 2017 Omnibus Equity Plan, and do not intend to make any awards pursuant to the 2008 Omnibus Equity Plan in the future, except that unused shares under the 2008 Omnibus Equity Plan have been carried over for use under the 2017 Omnibus Equity Plan.
+Added: We have not made any awards pursuant to the 2017 Omnibus Equity Plan or the Directors Plan since our shareholders approved the 2024 Omnibus Equity Plan, and do not intend to make any awards pursuant to the 2017 Omnibus Equity Plan or the Directors Plan in the future, except that unused shares under the 2017 Omnibus Equity Plan have been carried over for use under the 2024 Omnibus Equity Plan.
+Added: Awards outstanding under the 2017 Omnibus Equity Plan and the Directors Plan as of the date our shareholders approved the 2024 Omnibus Equity Plan will remain outstanding and subject to the terms and conditions of the 2017 Omnibus Equity Plan and the Directors Plan, as applicable, and the relevant award agreements.
Stock Options
8 unchanged sentences
Weighted Average Remaining Contractual Term
−Removed: Outstanding at December 31, 2022
−Removed: 81,000 $ 301.85 9.9 years
+Added: Outstanding at December 31, 2023 81,000 $ 301.85 8.9 years
Forfeited — —
−Removed: Outstanding at December 31, 2023
−Removed: 81,000 $ 301.85 8.9 years
−Removed: Exercisable at December 31, 2023
−Removed: 27,000 $ 301.85 8.9 years
+Added: Outstanding at December 31, 2024 81,000 $ 301.85 7.9 years
+Added: Exercisable at December 31, 2024 54,000 $ 301.85 7.9 years
AND SUBSIDIARIES
1 unchanged sentence
Market Stock Units
−Removed: MSUs awarded to employees prior to 2014 vested in four equal annual increments beginning on the first anniversary of the grant date.
−Removed: Participants may ultimately earn between zero and 150.0 % of the target number of units granted based on actual stock performance.
MSUs awarded to employees in 2014 and thereafter vest in three equal annual increments beginning on the first anniversary of the grant date, and participants may ultimately earn between zero and 200.0 % of the target number of units granted based on actual stock performance.
4 unchanged sentences
Beginning in 2022 we no longer grant MSUs as part of our long term incentive program and have replaced with granting performance-vested RSUs.
−Removed: MSUs granted in 2021 had a weighted average grant date fair value of $ 358.77 .
The following table summarizes our MSU activity:
6 unchanged sentences
Unvested at December 31, 2024 — $ —
−Removed: We value grants of MSUs using a lattice model with a Monte Carlo simulation.
−Removed: This valuation methodology utilizes several key assumptions, the 30 calendar day average closing stock price on the date of grant for MSUs, expected volatility of our stock price, risk-free rates of return and expected dividend yield.
−Removed: The assumptions used in our valuation are summarized as follows:
−Removed: December 31, 2021
−Removed: Expected dividend yield — %
−Removed: Range of expected stock price volatility 54.8 % - 61.6 %
−Removed: Range of risk-free interest rates 0.06 % - 0.21 %
−Removed: 30 calendar day average stock price on grant date $ 262.23 - $ 360.31
−Removed: Weighted-average per share grant date fair value $ 358.77
The fair values of MSUs vested in 2024, 2023 and 2022 totaled $ 6.3 million, $ 20.7 million and $ 18.8 million, respectively.
7 unchanged sentences
Accordingly, additional PSUs may be issued or currently outstanding PSUs may be cancelled upon final determination of the number of units earned.
+Added: Beginning in 2022 we no longer grant MSUs as part of long term incentive program and have replaced with granting PSUs with a performance metric based on a three-year cumulative relative total shareholder return (rTSR) metric.
+Added: Beginning in 2024 we began granting PSUs with a performance metric based on the three-year cumulative aggregate growth rate of our earnings per share during the performance period.
AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: Beginning in 2022 we no longer grant MSUs as part of long term incentive program and have replaced with granting PSUs with a performance metric based on a three-year cumulative relative total shareholder return (rTSR) metric.
−Removed: The PSUs will vest on the third anniversary of the date of grant, with the number of PSUs earned based on this cumulative rTSR metric.
The following table summarizes our PSUs that settle in stock activity:
10 unchanged sentences
PSUs settled in stock granted in 2023 and 2022 had weighted average grant date fair values of $ 383.61 and $ 294.43 , respectively.
−Removed: We value grants of PSUs using a lattice model with a Monte Carlo simulation.
+Added: We value grants of PSUs with a performance metric based on a three-year cumulative rTSR metric using a lattice model with a Monte Carlo simulation.
This valuation methodology utilizes several key assumptions, the 30 calendar day average closing stock price on the date of grant for PSUs, expected volatility of our stock price, risk-free rates of return and expected dividend yield.
1 unchanged sentence
For the Years Ended December 31,
+Added: 2024 2023 2022
Expected dividend yield — %
25 unchanged sentences
Unvested at December 31, 2024 —
−Removed: (1) PSUs settled in cash granted in 2023 represent the adjustment recorded to reflect the total number of units earned based on the finalization of the related performance multiplier for awards previously granted in 2020.
The fair values of PSUs settled in cash that vested in 2024, 2023 and 2022 totaled $ 9.5 million, $ 11.7 million and $ 11.0 million, respectively.
17 unchanged sentences
Employee Stock Purchase Plan
+Added: 2024 Employee Stock Purchase Plan
In June 2024 our shareholders approved the 2024 ESPP.
−Removed: The maximum aggregate number of shares of our common stock that may be purchased under the 2015 ESPP is 6.2 million.
+Added: The 2024 ESPP, which became effective on July 1, 2024, replaced the 2015 ESPP, which expired on June 30, 2024.
+Added: The maximum number of shares of our common stock that may be purchased under the 2024 ESPP is 2.5 million.
The following table summarizes our ESPP activity:
2 unchanged sentences
Shares issued under the 2024 ESPP 40,000 — —
+Added: Shares issued under the 2015 ESPP 175,000 199,000 241,000
Cash received under the 2024 ESPP $ 5.1 $ — $ —
+Added: Cash received under the 2015 ESPP $ 31.2 $ 45.1 $ 44.2
AND SUBSIDIARIES
24 unchanged sentences
As of December 31, 2024 and 2023, we have accrued income tax liabilities of $ 234.0 million and $ 419.5 million, respectively, under the Transition Toll Tax.
−Removed: Of the amounts accrued as of December 31, 2023, approximately $ 185.4 million is expected to be paid within one year.
+Added: The amount accrued as of December 31, 2024, is expected to be paid within one year.
The Transition Toll Tax is being paid in installments over an eight--year period, which started in 2018, and will not accrue interest.
16 unchanged sentences
Intangibles, net 989.6 1,153.9
−Removed: Neurimmune's tax basis in ADUHELM — 470.3
IRC Section 174 capitalized research and development 733.9 570.8
9 unchanged sentences
GILTI ( 1,054.8 ) ( 1,136.9 )
−Removed: Tax credits — ( 228.7 )
Depreciation, amortization and other ( 214.9 ) ( 215.7 )
1 unchanged sentence
As of December 31, 2024, 2023, 2022 and 2021, we had a valuation allowance of $ 1,013.7 million, $ 1,278.7 million, $ 2,003.3 million and $ 1,961.3 million, respectively, related to net operating losses in Switzerland and Neurimmune's tax basis in ADUHELM.
+Added: The change in the valuation allowance between December 31, 2024 and 2023, was primarily driven by movements in net operating loss deferred tax assets in Switzerland.
+Added: The net income tax impact of the changes in the valuation allowance was a benefit of approximately $ 56.8 million for the year ended December 31, 2024.
The change in the valuation allowance between December 31, 2023 and 2022, was primarily driven by a reduction of approximately $ 470.3 million related to the elimination of Neurimmune's tax basis in ADUHELM as a result of its deconsolidation and reduction of approximately $ 230.3 million due to movements in net operating loss deferred tax assets in Switzerland.
The net income tax impact of the changes in the valuation allowance was an expense of approximately $ 7.4 million for the year ended December 31, 2023.
−Removed: The change in the valuation allowance between December 31, 2022 and 2021, and between December 31, 2021 and 2020, was primarily driven by additions of $ 85.0 million and $ 390.0 million, respectively, related to Neurimmune's tax basis in ADUHELM.
+Added: The change in the valuation allowance between December 31, 2022 and 2021, was primarily driven by an addition of $ 85.0 million related to Neurimmune's tax basis in ADUHELM.
For additional information on the deconsolidation and our collaboration arrangement with Neurimmune, please read Note 20, Investments in Variable Interest Entities , to these consolidated financial statements.
10 unchanged sentences
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: The OECD has issued model rules, which generally provide for a jurisdictional minimum effective tax rate of 15.0% as defined in those rules.
+Added: Various countries have or are in the process of enacting legislation intended to implement the principles effective January 1, 2024.
+Added: Our income tax provision for the year ended December 31, 2024, reflects currently enacted legislation and guidance related to the OECD model rules.
+Added: This enacted legislation and guidance related to the OECD model rules did not result in any material adjustments to our income tax provision or income tax balances as of December 31, 2024.
A reconciliation between the U.S.
4 unchanged sentences
State taxes 1.8 1.1 1.1
−Removed: Taxes on foreign earnings ( 5.9 ) ( 4.9 ) ( 10.5 )
+Added: Taxes on foreign earnings, including valuation allowances ( 7.6 ) ( 5.9 ) ( 4.9 )
Tax credits ( 2.2 ) ( 7.3 ) ( 1.7 )
Purchased inventory valuation step-up and intangible assets
−Removed: 0.7 0.3 ( 1.6 )
GILTI ( 1.6 ) ( 0.6 ) 0.7
6 unchanged sentences
Changes in Tax Rate
+Added: For the year ended December 31, 2024, compared to 2023, the increase in our effective tax rate was partially driven by the relative deferred tax effects of the changes in the value of our equity investments and amortization of purchased intangible assets and inventory.
+Added: Further, 2023 benefited from the combined impacts of Reata acquisition-related expenses and the resolution of an uncertain tax matter related to tax credits.
+Added: This was partially offset by a 2024 benefit related to a decrease in our valuation allowance related to projected future foreign taxable income, as discussed in the Deferred Tax Assets and Liabilities section above.
For the year ended December 31, 2023, compared to 2022, the decrease in our effective tax rate was driven by the impact of the non-cash changes in the value of our equity investments, the impact of Fit for Growth related expenses and Reata acquisition-related expenses, as well as the combined net unfavorable tax rate impacts in 2022 related to a litigation settlement agreement, the sale of our equity interest in Samsung Bioepis, the impact of a Neurimmune valuation allowance, as discussed below, and an international reorganization to align with global tax developments.
The change also benefits from the resolution of an uncertain tax matter during the first quarter of 2023 related to tax credits.
−Removed: For the year ended December 31, 2022, compared to 2021, the increase in our effective tax rate, excluding the impact of the net Neurimmune deferred tax asset, as discussed below, includes the tax impacts of the litigation settlement agreement and the sale of our building at 125 Broadway.
−Removed: These increases were partially offset by the impact of the current year tax benefits related to an international reorganization to align with global tax developments, the impacts of the sale of our equity interest in Samsung Bioepis and the tax impacts of the decision to discontinue development of vixotrigine.
−Removed: Further in 2021, our effective tax rate benefited from the tax effects of the BIIB111 and BIIB112 impairment charges and the non-cash tax effects of changes in the value of our equity instruments.
For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to these consolidated financial statements.
1 unchanged sentence
Neurimmune Deferred Tax Asset
−Removed: During 2021 we recorded a net deferred tax asset in Switzerland of approximately $ 100.0 million on Neurimmune's tax basis in ADUHELM, the realization of which was dependent on future sales of ADUHELM.
−Removed: During the first quarter of 2022, upon issuance of the final NCD related to ADUHELM, we recorded an increase in a valuation allowance of approximately $ 85.0 million to reduce the net value of this deferred tax asset to zero.
−Removed: These adjustments to our net deferred tax asset were each recorded with an equal and offsetting amount assigned to net income (loss) attributable to noncontrolling interests, net of tax in our consolidated statements of income, resulting in a zero net impact to net income attributable to Biogen Inc.
+Added: During the first quarter of 2022, upon issuance of the final NCD related to ADUHELM, we recorded an increase in a valuation allowance of approximately $ 85.0 million to reduce the net value of a previously recorded deferred tax asset in Switzerland on Neurimmune's tax basis in ADUHELM, the realization of which was dependent on future sales of ADUHELM, to zero.
AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: This adjustment to our net deferred tax asset was recorded with an equal and offsetting amount assigned to net income (loss) attributable to noncontrolling interests, net of tax in our consolidated statements of income, resulting in a zero net impact to net income attributable to Biogen Inc.
During the fourth quarter of 2023 Neurimmune was deconsolidated from our consolidated financial statements.
1 unchanged sentence
Tax Attributes
−Removed: As of December 31, 2023, we had general business credit carry forwards for U.S.
+Added: As of December 31, 2024, we had credit carry forwards for U.S.
federal income tax purposes of approximately $ 163.0 million that begin to expire in 2030 and net operating losses of approximately $ 513.4 million that do not expire.
8 unchanged sentences
A reconciliation of the beginning and ending amount of our unrecognized tax benefits is summarized as follows:
+Added: For the Years Ended December 31,
(In millions) 2024 2023 2022
6 unchanged sentences
Ending balance $ 186.3 $ 173.4 $ 606.4
−Removed: During the year ended December 31, 2021, we increased our gross unrecognized tax benefits by approximately $ 455.0 million, related to a deferred tax asset for Swiss tax purposes for Neurimmune's tax basis in ADUHELM.
+Added: As of December 31, 2022, the unrecognized tax benefits related to a deferred tax asset for Swiss tax purposes for Neurimmune's tax basis in ADUHELM was approximately $ 450.0 million.
This unrecognized tax benefit was recorded as a reduction to the gross deferred tax asset, resulting in the net deferred tax asset, as discussed above, and not as a separate liability on our consolidated balance sheets.
−Removed: As of December 31, 2022, the unrecognized tax benefits related to Neurimmune was approximately $ 450.0 million.
During the year ended December 31, 2023, we decreased our gross unrecognized tax benefits by approximately $ 450.0 million related to this item as a result of the deconsolidation of Neurimmune.
6 unchanged sentences
Internal Revenue Service and other national tax authorities routinely examine our intercompany transfer pricing with respect to intellectual property related transactions and it is possible that they may disagree with one or more positions we have taken with respect to such valuations.
−Removed: Included in the balance of unrecognized tax benefits as of December 31, 2023, 2022 and 2021, are $ 147.6 million, $ 134.0 million and $ 87.5 million (net of the federal benefit on state issues), respectively, of unrecognized tax benefits that, if recognized, would affect the effective income tax rate in future periods.
AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: We recognize potential interest and penalties related to unrecognized tax benefits in income tax expense.
+Added: Included in the balance of unrecognized tax benefits as of December 31, 2024, 2023 and 2022, are $ 139.3 million, $ 147.6 million and $ 134.0 million (net of the federal benefit on state issues), respectively, of unrecognized tax benefits that, if recognized, would affect the effective income tax rate in future periods.
+Added: We recognize potential interest and penalties related to unrecognized tax benefits in income tax (benefit) expense within our consolidated statements of income.
During the years ended December 31, 2024, 2023 and 2022, we recognized total interest and penalty expense of $ 13.8 million, $ 5.1 million and $ 0.7 million, respectively.
4 unchanged sentences
Supplemental Cash Flow Information
−Removed: Supplemental disclosure of cash flow information for the years ended December 31, 2023, 2022 and 2021, is as follows:
+Added: Supplemental disclosure of cash flow information is summarized as follows:
For the Years Ended December 31,
7 unchanged sentences
(In millions) 2024 2023 2022
−Removed: Gain on sale of equity interest in Samsung Bioepis (1)
−Removed: $ — $ ( 1,505.4 ) $ —
−Removed: Litigation settlement agreement and settlement fees — 917.0 —
Interest income $ ( 67.6 ) $ ( 276.5 ) $ ( 89.3 )
2 unchanged sentences
Foreign exchange (gains) losses, net 30.9 50.4 35.5
+Added: Gain on sale of equity interest in Samsung Bioepis (1)
+Added: — — ( 1,505.4 )
+Added: Litigation settlement agreement and settlement fees — — 917.0
Other, net 29.6 3.5 10.1
7 unchanged sentences
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: The following table summarizes our (gains) losses on investments, net that relates to our equity securities held as of December 31, 2023, 2022 and 2021:
+Added: The following table summarizes our (gains) losses on investments, net that relates to our equity securities held during the following periods:
For the Years Ended December 31,
3 unchanged sentences
Net unrealized (gains) losses recognized on equity securities $ 102.4 $ 270.0 $ 264.7
+Added: The net unrealized losses recognized during the year ended December 31, 2024, primarily reflect a decrease in the aggregate fair value of our investments in Sage common stock of approximately $ 101.4 million, partially offset by an increase in the fair value of Denali and Sangamo common stock of approximately $ 7.5 million.
The net unrealized losses recognized during the year ended December 31, 2023, primarily reflect a decrease in the aggregate fair value of our investments in Sage, Denali, Sangamo and Ionis common stock of approximately $ 248.5 million.
8 unchanged sentences
Royalties and licensing fees 190.2 191.5
−Removed: Reata acquisition-related accrued expense 117.5 —
+Added: Current portion of contingent consideration obligations 291.2 —
Other 704.0 955.9
14 unchanged sentences
COLUMVI, a bispecific antibody for the treatment of non-Hodgkin's lymphoma, which was granted accelerated approval by the FDA during the second quarter of 2023;
−Removed: and have the option to add other potential anti-CD20 therapies, pursuant to our collaboration arrangements with Genentech, a wholly-owned member of the Roche Group.
−Removed: For purposes of this footnote, we refer to RITUXAN and RITUXAN HYCELA collectively as RITUXAN.
+Added: and have the option to add other potential anti-CD20 therapies, pursuant to our collaboration arrangements with
AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: Genentech, a wholly-owned member of the Roche Group.
+Added: For purposes of this footnote, we refer to RITUXAN and RITUXAN HYCELA collectively as RITUXAN.
If we undergo a change in control, as defined in our collaboration agreement, Genentech has the right to present an offer to buy the rights to RITUXAN and we must either accept Genentech’s offer or purchase Genentech’s rights on the same terms as its offer.
10 unchanged sentences
net sales from 13.5 % and increasing up to 24.0 % if annual net sales exceed $ 900.0 million.
−Removed: There will be a 50.0 % reduction to these royalties if a biosimilar to OCREVUS is approved in the U.S.
+Added: There will be a 50.0 % reduction to these royalties upon the first entry of an FDA approved biosimilar to OCREVUS.
In addition, we receive a gross 3.0 % royalty on net sales of OCREVUS outside the U.S., with the royalty period lasting 11 years from the first commercial sale of OCREVUS on a country-by-country basis.
6 unchanged sentences
only, until the 11 year anniversary of the first commercial sale of OCREVUS in the U.S.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
LUNSUMIO (mosunetuzumab)
In January 2022 we exercised our option with Genentech to participate in the joint development and commercialization of LUNSUMIO.
−Removed: In connection with this exercise, we recorded a $ 30.0 million option exercise fee payable to Genentech in December 2021, which was recognized in research and development expense in our consolidated statements of income for the year ended December 31, 2021.
−Removed: We also recorded a charge of approximately $ 20.0 million to reimburse Genentech for our 30.0 % share of the costs incurred in developing this product candidate during 2021, which was recognized in research and development expense in our consolidated statements of income for the year ended December 31, 2021.
−Removed: For the year ended December 31, 2022, we recorded approximately $ 28.4 million in research and development expense and approximately $ 13.0 million in sales and marketing expense in our consolidated statements of income related to this collaboration.
−Removed: For the year ended December 31, 2023, we began to record our share of LUNSUMIO development and sales and marketing expense as a reduction of our share of pre-tax profits in revenue from anti-CD20 therapeutic programs within our consolidated statements of income.
Under our collaboration with Genentech, we were responsible for 30.0 % of development costs for LUNSUMIO prior to FDA approval and will be entitled to a tiered share of co-promotion operating profits and losses in the U.S., as summarized in the table below.
1 unchanged sentence
In December 2022 LUNSUMIO was granted accelerated approval by the FDA for the treatment of relapsed or refractory follicular lymphoma.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: Prior to regulatory approval, we record our share of the expense incurred by the collaboration for the development of anti-CD20 products in research and development expense and pre-commercialization costs within selling, general and administrative expense in our consolidated statements of income.
+Added: After an anti-CD20 product is approved, we record our share of the development and sales and marketing expense related to that product as a reduction of our share of pre-tax profits in revenue from anti-CD20 therapeutic programs.
+Added: For the year ended December 31, 2022, we recorded approximately $ 28.4 million in research and development expense and approximately $ 13.0 million in sales and marketing expense in our consolidated statements of income related to this collaboration.
+Added: For the year ended December 31, 2023, we began to record our share of LUNSUMIO development and sales and marketing expense as a reduction of our share of pre-tax profits in revenue from anti-CD20 therapeutic programs within our consolidated statements of income.
If we undergo a change in control, as defined in our collaboration agreement, Genentech will be deemed to have purchased our rights to LUNSUMIO in exchange for 30.0 % of the U.S.
21 unchanged sentences
gross sales of LUNSUMIO reach $ 350.0 million or (ii) January 1 of the calendar year following the calendar year in which the First Threshold Date occurs.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
In March 2023 the First Threshold Date was achieved.
1 unchanged sentence
Our share of RITUXAN pre-tax profits in the U.S.
−Removed: in excess of $ 50.0 million for the years ended December 31, 2022 and 2021, was 37.5 %.
+Added: in excess of $ 50.0 million for the year ended December 31, 2022, was 37.5 %.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
GAZYVA Profit Share
8 unchanged sentences
As a result, beginning in April 2023 the pre-tax profit share for GAZYVA was 35.0 %.
−Removed: Our share of GAZYVA pre-tax profits in excess of $ 50.0 million for the years ended December 31, 2022 and 2021, was 37.5 %.
+Added: Our share of GAZYVA pre-tax profits in excess of $ 50.0 million for the year ended December 31, 2022, was 37.5 %.
Revenue from Anti-CD20 Therapeutic Programs
18 unchanged sentences
In June 2018 we entered into a 10-year exclusive collaboration agreement with Ionis to develop novel ASO drug candidates for a broad range of neurological diseases for a total payment of $ 1.0 billion, consisting of an upfront payment of $ 375.0 million and the purchase of approximately 11.5 million shares of Ionis common stock at a cost of $ 625.0 million.
−Removed: Upon closing, we recorded $ 50.9 million of the $ 375.0 million upfront payment as prepaid services in our consolidated balance sheets and recognized the remaining $ 324.1 million as research and development expense in
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: our consolidated statements of income.
−Removed: The amount recorded as prepaid services represented the value of the employee resources committed to the arrangement to provide research and discovery services over the term of the agreement.
We have the option to license therapies arising out of this agreement and will be responsible for the development and commercialization of such therapies.
We may pay development milestones to Ionis of up to $ 125.0 million or $ 270.0 million for each program, depending on the indication plus an annual license fee, as well as royalties on potential net commercial sales.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
During the years ended December 31, 2024, 2023 and 2022, we incurred milestones of $ 7.5 million, $ 7.5 million and $ 10.0 million, respectively, related to the advancement of neurological targets identified under this agreement, which were recorded as research and development expense in our consolidated statements of income.
2 unchanged sentences
Under this agreement, we have the option to license therapies arising out of this collaboration and will be responsible for their development and commercialization of such therapies.
−Removed: Upon entering into this agreement, we made a $ 25.0 million upfront payment to Ionis and we may pay Ionis up to $ 260.0 million in additional development and regulatory milestone payments if new drug candidates advance to marketing approval.
+Added: We may pay Ionis up to $ 260.0 million in additional development and regulatory milestone payments if new drug candidates advance to marketing approval.
Upon commercialization, we may also pay Ionis up to $ 800.0 million in additional performance-based milestone payments and tiered royalties on potential net sales of such therapies.
In December 2021 we exercised our option with Ionis and obtained a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB115, an investigational ASO in development for SMA.
−Removed: In connection with this option exercise, we made an opt-in payment of $ 60.0 million to Ionis, which was recorded as research and development expense in our consolidated statements of income for the year ended December 31, 2021.
2013 Long-term Strategic Research Agreement
9 unchanged sentences
Following the option exercise, we are solely responsible for the costs and expense related to the development, manufacturing and commercialization of QALSODY.
−Removed: We may pay post-licensing milestone payments to Ionis of up to $ 55.0 million based on the successful achievement of certain regulatory and commercial milestones.
In April 2023 the FDA approved QALSODY for the treatment of ALS in adults who have a mutation in the SOD1 gene.
2 unchanged sentences
Under this agreement, we make royalty payments to Ionis on annual worldwide net sales of QALSODY using a tiered royalty rate between 11.0 % and 15.0 %, which are recognized in cost of sales within our consolidated statements of income.
+Added: During the year ended December 31, 2024, we incurred a milestone payment of $ 20.0 million to Ionis following the approval of QALSODY in the E.U., which was recorded within intangible assets, net in our consolidated balance sheets.
+Added: Additionally, during the year ended December 31, 2024, we accrued a milestone payment of $ 10.0 million to Ionis following the approval of QALSODY in Japan, which was recorded within intangible assets, net in our consolidated balance sheets, and is expected to be paid during the first quarter of 2025.
+Added: During the year ended December 31, 2023, we incurred a milestone payment of $ 16.0 million to Ionis following the FDA's approval of QALSODY, which was recorded within intangible assets, net in our consolidated balance sheets.
+Added: During the year ended December 31, 2022, we incurred a milestone payment of $ 17.0 million related to the advancement of a program under this agreement, which was recorded in research and development expense within our consolidated statements of income.
AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: During the year ended December 31, 2023, we incurred a milestone payment of $ 16.0 million to Ionis following the FDA's approval of QALSODY, which was recorded within intangible assets, net in our consolidated balance sheets.
−Removed: We may pay Ionis an additional milestone of $ 20.0 million if QALSODY receives regulatory approval in the E.U.
−Removed: During the years ending December 31, 2022 and 2021, we incurred milestones of $ 17.0 million and $ 10.0 million, respectively, related to the advancement of programs under this agreement, which were recorded as research and development expense in our consolidated statements of income.
2012 Ionis Agreement
5 unchanged sentences
In December 2019 we exercised our option with Ionis and obtained a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB080 (tau ASO), which is currently in Phase 2 development for the potential treatment of Alzheimer's disease.
−Removed: In connection with the option exercise, we made a payment of $ 45.0 million to Ionis, which was recorded as research and development expense in our consolidated statements of income.
+Added: In connection with the option exercise, we made a payment of $ 45.0 million to Ionis, which was recorded in research and development expense within our consolidated statements of income.
Future payments may include additional milestone payments of up to $ 155.0 million and royalties on future sales in the low- to mid-teens if we successfully develop the product candidate after option exercise.
−Removed: During the year ended December 31, 2022, we incurred a milestone payment of $ 10.0 million, related to the advancement of BIIB080 under this agreement, which was recorded within research and development expense in our consolidated statements of income.
+Added: During the year ended December 31, 2022, we incurred a milestone payment of $ 10.0 million, related to the advancement of BIIB080 under this agreement, which was recorded in research and development expense within our consolidated statements of income.
Eisai Co., Ltd.
11 unchanged sentences
In October 2017 Eisai exercised its ADUHELM Option and we entered into a new collaboration agreement for the joint development and commercialization of ADUHELM (aducanumab) (the ADUHELM Collaboration Agreement).
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: On March 14, 2022, we amended our ADUHELM Collaboration Agreement with Eisai.
+Added: In March 2022 we amended our ADUHELM Collaboration Agreement with Eisai.
As of the amendment date, we have sole decision making and commercialization rights worldwide on ADUHELM, and beginning January 1, 2023, Eisai receives only a tiered royalty based on net sales of ADUHELM, and no longer participates in sharing ADUHELM's global profits and losses.
2 unchanged sentences
In the event of an operational separation, we would work with Eisai to effect a timely transition of any development, manufacturing or commercial responsibilities regarding LEQEMBI from us to Eisai.
−Removed: In this scenario, as of six months following the change of control, our ongoing responsibility for LEQEMBI related cost-sharing would be reduced to an amount equal to 80.0 % of what we would have owed prior to the operational separation, and all other economic rights would remain unchanged.
+Added: In this scenario, as of six months following the change of control, our ongoing responsibility for LEQEMBI related cost-sharing would be reduced to an
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: amount equal to 80.0 % of what we would have owed prior to the operational separation, and all other economic rights would remain unchanged.
In addition, in the event either company undergoes a change of control in which the acquirer is engaged in commercialization of a competing product, as defined in the LEQEMBI Collaboration Agreement, the non-acquired party may also request that the acquired party cease commercializing the competing product.
3 unchanged sentences
Prior to receiving traditional approval, LEQEMBI had been granted accelerated approval by the FDA in January 2023, at which time it became commercially available in the U.S.
−Removed: Additionally, in September 2023 the Japanese Ministry of Health, Labor and Welfare approved LEQEMBI in Japan, which was subsequently launched in Japan in December 2023.
−Removed: Upon commercialization of LEQEMBI, we began recognizing our 50.0 % share of LEQEMBI product revenue, net and cost of sales, including royalties, within other revenue in our consolidated statements of income, as we are not the principal.
+Added: Outside of the U.S., LEQEMBI is now approved in Japan (September 2023), China (January 2024), South Korea (May 2024), Hong Kong (July 2024), Israel (July 2024), United Arab Emirates (August 2024), Great Britain (August 2024) and Mexico (December 2024).
+Added: Additionally, in January 2025 the FDA approved LEQEMBI monthly IV maintenance dosing for the treatment of early Alzheimer's disease.
+Added: Upon commercialization of LEQEMBI in the U.S., we began recognizing our 50.0 % share of LEQEMBI product revenue, net and cost of sales, including royalties, within Alzheimer's collaboration revenue in our consolidated statements of income, as we are not the principal.
Our share of LEQEMBI sales and marketing expense and development expense are recorded within selling, general and administrative expense and research and development expense, respectively, within our consolidated statements of income.
11 unchanged sentences
Beginning in 2019, Eisai was reimbursing us for 45.0 % of development and sales and marketing expense incurred by the collaboration for the advancement of ADUHELM.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
In March 2022 we amended our ADUHELM Collaboration Agreement with Eisai.
2 unchanged sentences
Once this limit was achieved, we became responsible for all ADUHELM related costs.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
A summary of development expense, sales and marketing expense and milestone payments related to our initial ADUHELM Collaboration Agreement is as follows:
−Removed: For the Year Ended December 31,
−Removed: (In millions) 2022 2021
+Added: (In millions) For the Year Ended December 31, 2022
Total ADUHELM Collaboration development expense $ 149.4
2 unchanged sentences
Biogen's share of the ADUHELM Collaboration sales and marketing expense reflected in selling, general and administrative expense and collaboration profit sharing/(loss reimbursement) in our consolidated statements of income 71.5
−Removed: Total ADUHELM Collaboration third party milestones — 100.0
−Removed: Biogen's share of reimbursement from Eisai of ADUHELM milestone payments reflected in collaboration profit sharing/(loss reimbursement) in our consolidated statements of income — 45
ADUHELM Co-promotion Profits and Losses
4 unchanged sentences
were recognized in collaboration profit sharing/(loss reimbursement) in our consolidated statements of income.
−Removed: For the years ended December 31, 2022 and 2021, we recognized net reductions to our operating expense of approximately $ 224.7 million and $ 233.2 million, respectively, to reflect Eisai's 45.0 % share of net collaboration losses in the U.S.
−Removed: For the year ended December 31, 2021, we recognized a net reduction to our operating expense of $ 45.0 million to reflect Eisai's 45.0 % share of the $ 100.0 million milestone payment made to Neurimmune related to the launch of ADUHELM in the U.S., which was recorded in collaboration profit sharing/(loss reimbursement) in our consolidated statements of income.
−Removed: During the fourth quarter of 2021 we recorded approximately $ 164.0 million of charges associated with the write-off of inventory and purchase commitments in excess of forecasted demand related to ADUHELM.
+Added: For the year ended December 31, 2022, we recognized net reductions to our operating expense of approximately $ 224.7 million to reflect Eisai's 45.0 % share of net collaboration losses in the U.S.
During the first quarter of 2022, as a result of the final NCD, we recorded approximately $ 275.0 million of charges associated with the write-off of inventory and purchase commitments in excess of forecasted demand related to ADUHELM.
−Removed: Additionally, for the years ended December 31, 2022 and 2021, we recorded approximately $ 111.0 million and $ 30.0 million, respectively, of aggregate gross idle capacity charges related to ADUHELM.
−Removed: These charges were recorded in cost of sales within our consolidated statements of income for the years ended December 31, 2022 and 2021.
−Removed: We recognized approximately $ 197.0 million and $ 99.0 million related to Eisai's 45.0 % share of inventory, idle capacity charges and contractual commitments in collaboration profit sharing/(loss reimbursement) within our consolidated statements of income for the years ended December 31, 2022 and 2021, respectively.
+Added: Additionally, for the year ended December 31, 2022, we recorded approximately $ 111.0 million of aggregate gross idle capacity charges related to ADUHELM.
+Added: These charges were recorded in cost of sales within our consolidated statements of income for the year ended December 31, 2022.
+Added: We recognized approximately $ 197.0 million related to Eisai's 45.0 % share of inventory, idle capacity charges and contractual commitments in collaboration profit sharing/(loss reimbursement) within our consolidated statements of income for the year ended December 31, 2022.
Amounts receivable from Eisai related to the agreements discussed above we re approximately $ 16.7 million a nd $ 1.4 million as of December 31, 2024 and 2023, respectively.
Amounts payable to Eisai related to the agreements discussed above we re approximately $ 138.0 million a nd $ 118.4 million as of December 31, 2024 and 2023, respectively.
−Removed: We have a collaboration agreement with UCB, effective November 2003, to jointly develop and commercialize dapirolizumab pegol, an anti-CD40L pegylated Fab, for the potential treatment of SLE and other future agreed
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: We have a collaboration agreement with UCB, effective November 2003, to jointly develop and commercialize dapirolizumab pegol, an anti-CD40L pegylated Fab, for the potential treatment of SLE and other future agreed indications.
Either we or UCB may propose development of dapirolizumab pegol in additional indications.
1 unchanged sentence
All costs incurred for agreed indications, including research, development, sales and marketing expense, are shared equally between us and UCB.
−Removed: If marketing approval is obtained, both companies will co-promote dapirolizumab pegol and share profits and losses equally.
+Added: If marketing approval is obtained, both companies will jointly commercialize dapirolizumab pegol and share profits and losses equally.
A summary of development expense related to the UCB collaboration agreement is as follows:
3 unchanged sentences
Biogen's share of the UCB collaboration development expense reflected in research and development expense in our consolidated statements of income 38.7 30.3 34.0
−Removed: In November 2017 we entered into an exclusive license and collaboration agreement with Alkermes Pharma Ireland Limited, a subsidiary of Alkermes, for VUMERITY, a novel fumarate for the treatment of RMS.
−Removed: In October 2019 the FDA approved VUMERITY in the U.S.
−Removed: for the treatment of RMS.
−Removed: During the fourth quarter of 2021 VUMERITY was approved for the treatment of RRMS in certain international markets.
−Removed: Under this agreement, we received an exclusive, worldwide license to develop and commercialize VUMERITY and we pay Alkermes royalties of 15.0 % on worldwide net commercial sales of VUMERITY, which are recognized in cost of sales within our consolidated statements of income.
−Removed: Royalties payable on net commercial sales of VUMERITY are subject, under certain circumstances, to tiered minimum annual payment requirements for a period of five years following FDA approval.
−Removed: Royalty cost of sales related to sales of VUMERITY for the years ended December 31, 2023, 2022 and 2021, totaled approximately $ 87.4 million, $ 83.0 million and $ 61.6 million, respectively.
−Removed: Alkermes is eligible to receive royalties in the high-single digits to sub-teen double digits of annual net commercial sales upon successful development and commercialization of new product candidates, other than VUMERITY, developed under the exclusive license from Alkermes.
−Removed: Alkermes currently supplies both VUMERITY and FAMPYRA to us pursuant to separate supply agreements.
−Removed: In October 2019 we entered into a new supply agreement and amended our license and collaboration agreement with Alkermes for VUMERITY.
−Removed: We have elected to initiate a technology transfer and, following a transition period, to manufacture VUMERITY or have VUMERITY manufactured by a third party we have engaged in exchange for paying an increased royalty rate to Alkermes on any portion of future worldwide net commercial sales of VUMERITY that is manufactured by us or our designee.
−Removed: In January 2023 we entered into a new supply agreement with Alkermes for FAMPYRA through January 2025.
−Removed: In December 2023 Alkermes entered into a definitive agreement to sell its development and manufacturing facility to Novo Nordisk, which is expected to close in mid-2024.
−Removed: Alkermes and Novo Nordisk plan to enter into subcontracting arrangements to continue work currently performed at the facility for a period of time after closing the transaction, which may continue through the end of 2025.
−Removed: Acorda Therapeutics, Inc.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: Merz Therapeutics (previously Acorda Therapeutics, Inc.)
In June 2009 we entered into a collaboration and license agreement with Acorda to develop and commercialize products containing fampridine, such as FAMPYRA, in markets outside the U.S.
1 unchanged sentence
net sales and we may pay potential milestone payments based on the successful achievement of certain regulatory and commercial milestones.
−Removed: In January 2024 we notified Acorda of our decision to terminate our collaboration and license agreement, effective January 1, 2025.
−Removed: As a result of this termination, Acorda will regain global commercialization rights to FAMPYRA.
+Added: In January 2024 we notified Acorda of our decision to terminate our collaboration and license agreement, effective January 1, 2025, whereby Acorda regained global commercialization rights to FAMPYRA.
+Added: On April 1, 2024, Acorda filed for bankruptcy protection and announced its intention to sell substantially all of Acorda's assets to a third party.
+Added: On July 10, 2024, Merz Therapeutics announced that its subsidiary Merz Pharmaceuticals LLC had completed the acquisition of FAMPYRA, and related assets from Acorda.
+Added: We are now working with Merz Therapeutics on the transition of global commercialization rights of FAMPYRA and we expect to recognize minimal revenue in 2025.
For the years ended December 31, 2024, 2023 and 2022, total cost of sales related to royalties and commercial supply of FAMPYRA reflected in our consolidated statements of income were approximately $ 52.4 million, $ 55.2 million and $ 46.1 million, respectively.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Sage Therapeutics, Inc.
In November 2020 we entered into a global collaboration and license agreement with Sage to jointly develop and commercialize ZURZUVAE (zuranolone) for the treatment of PPD and potential treatment of MDD and BIIB124 (SAGE-324) for the potential treatment of essential tremor with potential in other neurological conditions such as epilepsy.
+Added: In July 2024 we and Sage announced that the Phase 2 KINETIC 2 dose-range study of BIIB124 did not meet its endpoints.
+Added: Based on these results, we discontinued our further development of BIIB124 and terminated our rights under the collaboration and license agreement specific to BIIB124, effective February 17, 2025.
In connection with the closing of this transaction in December 2020 we purchased $ 650.0 million of Sage common stock, or approximately 6.2 million shares at approximately $ 104.14 per share, which were initially subject to transfer restrictions.
−Removed: We may pay Sage development and commercial milestone payments that could total up to approximately $ 1.6 billion if all the specified milestones set forth in this collaboration are achieved.
+Added: We may pay Sage development and commercial milestone payments that could total up to approximately $ 700.0 million if all the specified milestones set forth in this collaboration are achieved.
In August 2023 the FDA approved ZURZUVAE for adults with PPD, pending DEA scheduling, which was completed in October 2023.
3 unchanged sentences
Additionally, the FDA issued a CRL for the NDA for zuranolone in the treatment of adults with MDD.
−Removed: The CRL stated that the application did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD and that an additional study or studies would be needed.
−Removed: We and Sage are continuing to seek feedback from the FDA and evaluating next steps.
+Added: In October 2024 we and Sage agreed to not pursue further development of zuranolone for the potential treatment of MDD.
+Added: This decision was based on the significant new investment and time we expect would be needed to conduct the additional studies required to support approval of this indication.
Under this collaboration, both companies will share equal responsibility and costs for development as well as profits and losses for commercialization in the U.S.
1 unchanged sentence
During the fourth quarter of 2023 we accrued a milestone payment due to Sage of $ 75.0 million upon the first commercial sale of ZURZUVAE for PPD in the U.S., which was recorded within intangible assets, net in our consolidated balance sheets, and subsequently paid in January 2024.
−Removed: For the year ended December 31, 2023, we recognized net reductions to our operating expense of approximately $ 4.7 million to reflect Sage's 50.0 % share of net collaboration losses in the U.S., which is recognized in collaboration profit sharing/(loss reimbursement) in our consolidated statements of income.
+Added: We reflect revenue on sales of ZURZUVAE to third parties in product revenue, net in our consolidated statements of income and record the related cost of revenue and sales and marketing expense in our consolidated statements of income to their respective line items when these costs are incurred.
+Added: We share 50.0 % of the profit or loss related to our global collaboration and license agreement with Sage, which is recognized in collaboration profit sharing/(loss reimbursement) in our consolidated statements of income.
+Added: For the years ended December 31, 2024 and 2023, we recognized net profit-sharing expense of approximately $ 27.0 million and net loss reimbursement of approximately $ 4.7 million, respectively, to reflect Sage's 50.0 % share
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: of net collaboration losses in the U.S., which are recognized in collaboration profit sharing/(loss reimbursement) in our consolidated statements of income.
A summary of development and sales and marketing expense related to the Sage collaboration is as follows:
5 unchanged sentences
Biogen's share of the Sage collaboration sales and marketing expense reflected in selling, general and administrative expense and collaboration profit sharing/(loss reimbursement) in our consolidated statements of income 59.2 93.5 55.0
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Denali Therapeutics Inc.
In August 2020 we entered into a collaboration and license agreement with Denali to co-develop and co-commercialize Denali's small molecule inhibitors of LRRK2 for Parkinson's disease (LRRK2 Collaboration) and also entered into a separate agreement to obtain an exclusive option to license two preclinical programs from Denali's Transport Vehicle platform, including its ATV-enabled anti-amyloid beta program and a second program utilizing its Transport Vehicle technology.
+Added: In July 2024 we terminated our license with Denali for the ATV-enabled anti-amyloid beta program.
+Added: This termination also resulted in the termination of the exclusive option agreement, as discussed above.
As part of this collaboration we purchased $ 465.0 million of Denali common stock in September 2020, or approximately 13 million shares at approximately $ 34.94 per share, which were initially subject to transfer restrictions.
We may pay Denali development and commercial milestone payments that could total up to approximately $ 1.1 billion if the milestones related to the LRRK2 Collaboration are achieved.
−Removed: In April 2023 we exercised our option with Denali to license the ATV-enabled anti-amyloid beta program.
−Removed: In connection with this exercise, we assumed responsibility for all development and commercial activities and associated expenses related to this program.
−Removed: In addition, we made a one-time option exercise payment to Denali and, should certain milestones be achieved, may pay Denali additional development and commercial milestone payments and royalties based on future net sales.
−Removed: Our agreement with Denali was amended in August 2023, whereby certain milestone criteria were changed, while the total amount of development, regulatory and commercial milestones remains the same.
−Removed: In addition, we agreed to waive our option right to the second option program.
Under the LRRK2 Collaboration, both companies share responsibility and costs for global development based on specified percentages as well as profits and losses for commercialization in the U.S.
16 unchanged sentences
Biogen's share of the Sangamo collaboration development expense reflected in research and development expense in our consolidated statements of income 2.4 12.1
−Removed: InnoCare Pharma Limited
−Removed: In July 2021 we entered into a collaboration and license agreement with InnoCare Pharma Limited (InnoCare) for orelabrutinib, an oral small molecule Bruton's tyrosine kinase inhibitor for the potential treatment of MS.
−Removed: In connection with the closing of this transaction in August 2021 we made an upfront payment of $ 125.0 million that was recorded as research and development expense within our consolidated statements of income for the year ended December 31, 2021.
AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: In February 2023 we terminated our collaboration and license agreement with InnoCare for orelabrutinib, for the potential treatment of MS.
Other Research and Discovery Arrangements
9 unchanged sentences
Under the terms of this transaction, we received approximately $ 1.0 billion in cash at closing, with approximately $ 1.3 billion in cash to be deferred over two payments.
−Removed: The first deferred payment of $ 812.5 million was received in April 2023 and the second deferred payment of $ 437.5 million is due at the second anniversary of the closing of this transaction in April 2024.
+Added: The first deferred payment of $ 812.5 million was received in April 2023 and the second deferred payment of $ 437.5 million was received in April 2024.
As part of this transaction, we are also eligible to receive up to an additional $ 50.0 million upon the achievement of certain commercial milestones.
7 unchanged sentences
Following the sale of Samsung Bioepis we no longer recognize gains or losses associated with Samsung Bioepis' results of operations and amortization related to basis differences.
−Removed: For the year ended December 31, 2021, we recognized net income on our investment of $ 34.9 million, reflecting our share of Samsung Bioepis' operating profits, net of tax, totaling $ 64.6 million offset by amortization of basis differences totaling $ 29.7 million.
−Removed: Net income on our investment for the year ended December 31, 2021, reflects a $ 31.2 million benefit related to the release of a valuation allowance on deferred tax assets associated with Samsung Bioepis.
−Removed: The valuation allowance was released in the second quarter of 2021 based on a consideration of the positive and negative evidence, including the historic earnings of Samsung Bioepis.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 3, Dispositions , to these consolidated financial statements.
2019 Development and Commercialization Agreement
−Removed: In December 2019 we completed a transaction with Samsung Bioepis and secured the exclusive rights to commercialize two potential ophthalmology biosimilar products, BYOOVIZ (ranibizumab-nuna), a ranibizumab biosimilar referencing LUCENTIS, and SB15, a proposed aflibercept biosimilar referencing EYLEA, in major markets worldwide, including the U.S., Canada, Europe, Japan and Australia.
−Removed: Samsung Bioepis will be responsible for development and will supply both products to us at a pre-specified gross margin of approximately 45.0 %.
−Removed: During the third quarter of 2021 we accrued $ 15.0 million in milestone payments related to the approval of BYOOVIZ in the U.S., the E.U.
−Removed: and the U.K., that were capitalized within intangible assets, net in our consolidated balance sheets.
−Removed: We may also pay Samsung Bioepis up to approximately $ 180.0 million in additional development, regulatory and sales-based milestones.
+Added: In December 2019 we completed a transaction with Samsung Bioepis and secured the exclusive rights to commercialize two potential ophthalmology biosimilar products, BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, and OPUVIZ, an aflibercept biosimilar referencing EYLEA, in major markets worldwide, including the U.S., Canada, Europe, Japan and Australia.
+Added: The agreement established that Samsung Bioepis will be responsible for development and will supply both products to us at a pre-specified gross margin of approximately 45.0 %.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: In October 2024 we notified Samsung Bioepis of our decision to terminate our 2019 Development and Commercialization Agreement (the DCA Agreement) solely within the U.S.
+Added: As a result of this termination we recognized impairment charges of approximately $ 20.2 million, which were recorded within amortization and impairment of acquired intangible assets within our consolidated statements of income for the year ended December 31, 2024.
+Added: Biogen will transfer commercialization rights for BYOOVIZ and OPUVIZ in the U.S.
+Added: and Canada back to Samsung Bioepis over a period of up to 18 months.
+Added: During this transition period, we will continue to commercialize BYOOVIZ.
+Added: The termination does not impact the other markets in the DCA Agreement.
+Added: In the fourth quarter of 2024 we made a milestone payment of $ 15.0 million to Samsung Bioepis related to the approval of OPUVIZ in the E.U., which was recorded within intangible assets, net in our consolidated balance sheets.
+Added: We may also pay Samsung Bioepis up to approximately $ 150.0 million in additional development, regulatory and sales-based milestones associated with the remaining major markets covered by the agreement.
+Added: We reflect revenue on sales of BYOOVIZ to third parties in product revenue, net in our consolidated statements of income and record the related cost of revenue and sales and marketing expense in our consolidated statements of income to their respective line items when these costs are incurred.
2013 Commercial Agreement
−Removed: In December 2013 we entered into an agreement with Samsung Bioepis to commercialize, over a 10-year term, 3 anti-TNF biosimilar product candidates which includes IMRALDI, an adalimumab biosimilar referencing HUMIRA, FLIXABI, an infliximab biosimilar referencing REMICADE, and BENEPALI, an etanercept biosimilar referencing ENBREL, in Europe, and in the case of BENEPALI, Japan.
−Removed: We have an option to extend this agreement by an additional five years , subject to payment of an option exercise fee of $ 60.0 million by August 2024.
−Removed: We also have an option to acquire exclusive rights to commercialize these products in China.
+Added: In December 2013 we entered into an agreement with Samsung Bioepis to commercialize, over a 10-year term, 3 anti-TNF biosimilar product candidates which includes IMRALDI, an adalimumab biosimilar referencing HUMIRA, FLIXABI, an infliximab biosimilar referencing REMICADE, and BENEPALI, an etanercept biosimilar referencing ENBREL, in Europe.
+Added: In July 2024 we exercised an option to extend this agreement by an additional five years , and paid Samsung Bioepis an option exercise fee of $ 60.0 million, which was recorded within intangible assets, net within our consolidated balance sheets as of December 31, 2024.
We reflect revenue on sales of BENEPALI, IMRALDI and FLIXABI to third parties in product revenue, net in our consolidated statements of income and record the related cost of revenue and sales and marketing expense in our consolidated statements of income to their respective line items when these costs are incurred.
1 unchanged sentence
We share 50.0 % of the profit or loss related to our 2013 commercial agreement with Samsung Bioepis, which is recognized in collaboration profit sharing/(loss reimbursement) in our consolidated statements of income.
−Removed: For the years ended December 31, 2023, 2022 and 2021, we recognized net profit-sharing expense o f $ 223.5 million , $ 217.4 million and $ 285.4 million, respectively, to reflect Samsung Bioepis' 50.0 % sharing of the net collaboration profits.
+Added: For the years ended December 31, 2024, 2023 and 2022, we recognized net profit-sharing expense o f approximately $ 227.4 million , $ 223.5 million and $ 217.4 million, respectively, to reflect Samsung Bioepis' 50.0 % sharing of the net collaboration profits.
Other Services
3 unchanged sentences
Royalty revenue under the license agreement is recognized as a component of contract manufacturing, royalty and other revenue in our consolidated statements of income.
−Removed: For the years ended December 31, 2023, 2022 and 2021, we recognized $ 13.6 million, $ 20.6 million and $ 20.7 million, respectively, as a component of contract manufacturing, royalty and other revenue in our consolidated statements of income related to the license agreement and other services performed under our collaboration with Samsung Bioepis.
−Removed: Amounts receivable from Samsung Bioepis related to the agreements discussed above were $ 9.9 million and $ 2.0 million as of December 31, 2023 and 2022, respectively.
−Removed: Amounts payable to Samsung Bioepis related to the agreements discussed above were $ 73.7 million and $ 40.5 million as of December 31, 2023 and 2022, respectively.
+Added: For the years ended December 31, 2024, 2023 and 2022, we recognized approximately $ 14.4 million, $ 13.6 million and $ 20.6 million, respectively, as a component of contract manufacturing, royalty and other revenue in our consolidated statements of income related to the license agreement and other services performed under our collaboration with Samsung Bioepis.
+Added: Amounts receivable from Samsung Bioepis related to the agreements discussed above were approximately $ 7.6 million and $ 9.9 million as of December 31, 2024 and 2023, respectively.
+Added: Amounts payable to Samsung Bioepis related to the agreements discussed above were approximately $ 60.8 million and $ 73.7 million as of December 31, 2024 and 2023, respectively.
AND SUBSIDIARIES
10 unchanged sentences
As a result, we recorded a net gain on the deconsolidation of Neurimmune of approximately $ 3.0 million, which was recorded in other (income) expense, net within our consolidated statements of income for the year ended December 31, 2023.
−Removed: In June 2021 ADUHELM was granted accelerated approval by the FDA.
−Removed: Under the terms of the Neurimmune Agreement, we were required to pay Neurimmune a milestone payment of $ 100.0 million related to the launch of ADUHELM in the U.S.
−Removed: During the second quarter of 2021 we made this $ 100.0 million payment, which was recognized as a charge to net income (loss) attributable to noncontrolling interests, net of tax in our consolidated statements of income.
−Removed: In addition, during the second quarter of 2021 we recognized net profit-sharing income of $ 45.0 million to reflect Eisai's 45.0 % share of the $ 100.0 million milestone payment, which was recognized in collaboration profit sharing/(loss reimbursement) in our consolidated statements of income.
−Removed: During 2021 we recorded a net deferred tax asset in Switzerland of approximately $ 100.0 million on Neurimmune's tax basis in ADUHELM, the realization of which was dependent on future sales of ADUHELM.
−Removed: During the first quarter of 2022, upon issuance of the final NCD related to ADUHELM, we recorded an increase in a valuation allowance of approximately $ 85.0 million to reduce the net value of this deferred tax asset to zero.
−Removed: These adjustments to our net deferred tax asset were each recorded with an equal and offsetting amount assigned to net income (loss) attributable to noncontrolling interests, net of tax in our consolidated statements of income, resulting in a zero net impact to net income attributable to Biogen Inc.
+Added: During the first quarter of 2022, upon issuance of the final NCD related to ADUHELM, we recorded an increase in a valuation allowance of approximately $ 85.0 million to reduce the net value of a previously recorded deferred tax asset in Switzerland on Neurimmune's tax basis in ADUHELM, the realization of which was dependent on future sales of ADUHELM, to zero.
+Added: This adjustment to our net deferred tax asset was recorded with an equal and offsetting amount assigned to net income (loss) attributable to noncontrolling interests, net of tax in our consolidated statements of income, resulting in a zero net impact to net income attributable to Biogen Inc.
Excluding the impact of the Neurimmune deferred tax asset, the assets and liabilities of Neurimmune are not significant to our consolidated financial position or results of operations as it is a research and development organization.
9 unchanged sentences
We have also entered into research collaboration agreements with certain variable interest entities where we are required to fund certain development activities.
−Removed: These development activities are included in research and
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: development expense in our consolidated statements of income as they are incurred.
+Added: These development activities are included in research and development expense in our consolidated statements of income as they are incurred.
We have provided no financing to these variable interest entities other than previous contractually required amounts.
We are currently involved in various claims, investigations and legal proceedings, including the matters described below.
−Removed: For information as to our accounting policies relating to claims and legal proceedings, including use of estimates and contingencies, please read Note 1, Summary of Significant Accounting Policies , to these consolidated financial statements.
+Added: For information as to our accounting policies relating to claims and legal proceedings, including use of
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: estimates and contingencies, please read Note 1, Summary of Significant Accounting Policies , to these consolidated financial statements.
With respect to some loss contingencies, an estimate of the possible loss or range of loss cannot be made until management has further information, including, for example, (i) which claims, if any, will survive dispositive motion practice;
11 unchanged sentences
Loss Contingencies
−Removed: ADUHELM Securities Litigation
−Removed: We and certain current and former officers are defendants in two actions related to ADUHELM filed in the United States District Court for the District of Massachusetts (the District Court).
−Removed: Both actions allege violations of federal securities laws under 15 U.S.C.
+Added: Securities Litigation asserted against Biogen
+Added: We and certain current and former officers are defendants in three securities actions pending in the District Court, one filed by Nadia Shash and Amjad Khan in November 2020 and related to statements about ADUHELM, one filed by the Oklahoma Firefighters Pension and Retirement System in February 2022 and related to statements about ADUHELM, and one filed by Thomas Allen Gray in June 2024 and related to statements about LEQEMBI, TECFIDERA and VUMERITY.
+Added: All allege violations of federal securities laws under 15 U.S.C.
§78j(b) and §78t(a) and 17 C.F.R.
§240.10b-5 and seek declarations of the actions as class actions and monetary relief.
−Removed: In October 2023 the United States Court of Appeals for the First Circuit reversed in part and affirmed in part the dismissal of the shareholder action related to ADUHELM that was filed in November 2020.
−Removed: In March 2023 the District Court dismissed the shareholder action that was filed in February 2022.
−Removed: In May 2023 the plaintiff filed a motion to alter the judgment and amend the complaint, which is pending.
Derivative Actions
−Removed: We and members of the Board of Directors are named as defendants in derivative actions filed by shareholders in February and July 2022, in the U.S.
−Removed: District Court for the District of Massachusetts.
−Removed: The actions allege violations of federal securities laws under 15 U.S.C.
−Removed: §78n(a) and 17 C.F.R.
−Removed: §240 14.a-9, and breaches of fiduciary duties and waste of corporate assets, and seek declaratory and injunctive relief, monetary relief payable to Biogen, and attorneys’ fees and costs payable to the plaintiffs.
−Removed: The Court has stayed both cases.
+Added: We and members of the Board of Directors are named as defendants in five derivative actions pending in the District Court, one filed by The Booth Family Trust in February 2022, one filed by Elaine Wang in July 2022, one filed by Jonathan Blaufarb (Blaufarb I) in July 2024, one filed by Lawrence Hollin in October 2024 and one filed by Jonathan Blaufarb (Blaufarb II) in October 2024.
+Added: The Booth, Wang and Blaufarb II actions relate to ADUHELM and other matters, and the Blaufarb I and Hollin actions relate to statements about LEQEMBI, our compliance controls, 2023 earnings guidance and other matters.
+Added: The actions allege breach of fiduciary duty, waste of corporate assets and other common law claims, and violations of the Securities Exchange Act of 1934, 15 U.S.C.
+Added: The actions seek declaratory and injunctive relief, monetary relief payable to Biogen, and attorneys’ fees and costs payable to the plaintiffs.
+Added: The Booth and Wang actions are stayed.
IMRALDI Patent Litigation
−Removed: In June 2022 Fresenius Kabi Deutschland GmbH (Fresenius Kabi) filed a claim for damages and injunctive relief against Biogen France SAS in the Tribunal de Grande Instance de Paris, alleging that IMRALDI, the adalimumab biosimilar product of Samsung Bioepis that Biogen commercializes in Europe, infringes the French counterpart of European Patent 3 145 488 (the EP ‘488 Patent), which expires in May 2035.
−Removed: In August 2022 Fresenius Kabi filed a claim for damages and injunctive relief against Biogen GmbH in the Düsseldorf Regional Court, alleging infringement of the German counterpart of the EP '488 Patent.
−Removed: A hearing in the Düsseldorf Regional Court was held in December 2023 and a decision is pending.
−Removed: The EP '488 Patent is the subject of opposition proceedings in the EPO Technical Boards of Appeal.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: In June 2024, the Technical Boards of Appeal of the European Patent Office upheld the validity of Fresenius Kabi Deutschland GmbH's (Fresenius Kabi's) European Patent 3 145 488 (the EP '488 Patent), which expires in May 2035.
+Added: In June 2022 Fresenius Kabi filed a claim for damages and injunctive relief against Biogen France SAS in the Tribunal de Grande Instance de Paris alleging that IMRALDI, the adalimumab biosimilar product of Samsung Bioepis that Biogen commercializes in Europe, infringes the French counterpart of the EP ‘488 Patent.
+Added: In March 2024 the Düsseldorf Regional Court dismissed Fresenius Kabi's claim of infringement of the German counterpart of the EP '488 Patent and Fresenius Kabi has appealed to the Higher Regional Court of Düsseldorf.
Litigation with Former Convergence Shareholders
1 unchanged sentence
In 2019 Shareholder Representative Services LLC, on behalf of the former shareholders of Convergence, asserted claims of $ 200.0 million for alleged breaches of the contract pursuant to which we acquired Convergence.
−Removed: In June 2023 Shareholder Representative Services LLC and 24 former shareholders filed suit against us in the High Court of Justice of England and Wales on one of the previously asserted claims, seeking payment of $ 49.9 million, interest and costs.
−Removed: ERISA Class Action Litigation
−Removed: In 2020 participants in the Biogen 401(k) Savings Plan filed actions against us in the U.S.
−Removed: District Court for the District of Massachusetts alleging breach of fiduciary duty under ERISA and seeking a declaration of the actions as class actions and monetary and other relief.
−Removed: In January 2024 the Court granted final approval of a settlement under which we agreed to pay $ 9.75 million without any admission of liability and dismissed the actions with prejudice.
+Added: In June 2023 Shareholder Representative Services LLC and 24 former shareholders filed a suit against us in the High Court of Justice of England and Wales asserting one of the 2019 claims and seeking payment of $ 49.9 million, interest and costs.
Humana Patient Assistance Litigation
−Removed: In March 2023 the U.S.
−Removed: District Court for the District of Massachusetts dismissed the previously disclosed action filed against us by Humana in September 2020.
−Removed: Humana had alleged damages related to our providing MS patients with free medications and making charitable contributions to non-profit organizations that assist MS patients and had alleged violations of the federal RICO Act and state laws.
−Removed: In December 2023 Humana appealed to the United States Court of Appeals for the First Circuit and the appeal is pending.
+Added: In March 2023 the District Court dismissed the previously disclosed action filed against us by Humana in September 2020.
+Added: Humana had alleged damages related to our providing MS patients with free medications and making
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: charitable contributions to non-profit organizations that assist MS patients and had alleged violations of the federal RICO Act and state laws.
+Added: In January 2025 the United States Court of Appeals for the First Circuit affirmed the District Court's dismissal of this action.
Genentech Litigation
1 unchanged sentence
filed suit against us in the U.S.
−Removed: District Court for the Northern District of California, alleging that it is owed royalties on sales of TYSABRI that occurred after the expiration of a patent licensed by Genentech to Biogen, together with interest and costs.
−Removed: The Company estimates that the royalties claimed total approximately $ 88.3 million.
−Removed: Bardoxolone Securities Litigation
−Removed: In 2021 and 2022 putative stockholders of Reata (later acquired by Biogen) filed litigation in the United States District Court for the Eastern District of Texas alleging violations of the federal securities laws by Reata, certain former officers and directors and certain underwriters under 15 U.S.C.
−Removed: §78j(b) and §78t(a), 17 C.F.R.
−Removed: §240.10b-5, and 15 U.S.C.
−Removed: §§77k, 77l(a)(2) and 77o in connection with Reata's asset bardoxolone.
−Removed: Plaintiffs seek declaration of the actions as a class actions and monetary relief.
−Removed: In October 2023 the parties reached a settlement providing for payment by Reata of $ 45.0 million without any admission of liability.
−Removed: The Court preliminarily approved the settlement in November 2023 and has set a final fairness hearing for March 2024.
−Removed: We expect a portion of the payment to be reimbursed under Reata's insurance coverage.
−Removed: Lender Dispute
−Removed: One of Reata's lenders claims that approximately $ 23.3 million is owing under a loan agreement with Reata.
+Added: District Court for the Northern District of California and claims that it is owed royalties of approximately $ 92.7 million on sales of TYSABRI that occurred after the expiration of a patent licensed by Genentech to Biogen, plus interest and costs.
+Added: Lender Litigation
+Added: In April 2024, BioPharma Credit PLC, BPCR Limited Partnership, and BioPharma Credit Investments V (Master) LP filed suit against us and Reata Pharmaceuticals, Inc.
+Added: in the Supreme Court of the State of New York alleging breach of a loan agreement with Reata and seeking payment of approximately $ 23.2 million, plus interest, costs and attorneys' fees.
+Added: Antitrust Litigation
+Added: In August and September 2024, four suits were filed against us in the U.S.
+Added: District Court for the Northern District of Illinois and have been consolidated for pretrial purposes.
+Added: Plaintiffs are Local No.
+Added: 1 Health Fund, the Mayor and City Council of Baltimore, Teamsters Local 237 Welfare Fund and Teamsters Local 237 Retirees' Benefit Fund, New York State Teamsters Council Health and Hospital Fund, and UFCW Local 1500 Welfare Fund.
+Added: Plaintiffs allege violations of federal antitrust laws including 15 U.S.C.
+Added: §§ 1, 2 and 13(c) and of various state laws, based on contracts with pharmacy benefit managers related to TECFIDERA and VUMERITY.
+Added: Plaintiffs seek declarations of the actions as class actions, monetary, declaratory and equitable relief, and attorneys' fees and costs.
Other Matters
Government Investigations
−Removed: The Company has received subpoenas from the SEC seeking information relating to ADUHELM and its launch.
−Removed: The Company has received a subpoena from the DOJ seeking information relating to our business operations in several foreign countries.
−Removed: The Company is also providing information relating to our business operations in several foreign countries to the SEC.
+Added: We have received subpoenas from the SEC seeking information relating to ADUHELM and its launch, and our equity plans.
+Added: We have also received subpoenas from the DOJ and SEC seeking information relating to our business operations in several foreign countries.
+Added: The Italian Competition Authority is investigating Biogen and other companies in relation to our biosimilar product BYOOVIZ.
TYSABRI Biosimilar Patent Matter
3 unchanged sentences
§262, seeking a declaratory judgment of patent infringement.
−Removed: Annulment Proceedings in the General Court of the European Union relating to TECFIDERA
−Removed: In November 2020 Mylan Ireland filed an action in the General Court of the European Union to annul the EMA's decision not to validate its applications to market generic versions of TECFIDERA on the grounds that TECFIDERA benefits from regulatory data protection.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Hatch-Waxman Act Litigation relating to VUMERITY Orange-Book Listed Patents
3 unchanged sentences
Product Liability and Other Legal Proceedings
−Removed: We are also involved in product liability claims and other legal proceedings generally incidental to our normal business activities.
+Added: We are also involved in product liability claims and other legal proceedings incidental to our normal business activities.
While the outcome of any of these proceedings cannot be accurately predicted, we do not believe the ultimate resolution of any of these existing matters would have a material adverse effect on our business or financial condition.
17 unchanged sentences
For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to these consolidated financial statements.
+Added: Contingent Consideration related to Business Combinations
+Added: In connection with our acquisition of HI-Bio in July 2024 we may make additional payments based upon the achievement of certain milestone events.
+Added: We recognized the contingent consideration obligations associated with this acquisition at its fair value on the acquisition date and we revalue this obligation each reporting period.
+Added: We may pay up to an additional $ 650.0 million in potential future development and regulatory milestone payments.
+Added: The acquisition-date fair value of these milestones was approximately $ 485.1 million.
Regulatory and Commercial Milestone Payments
−Removed: Based on our development plans as of December 31, 2023, we could trigger potential future milestone payments to third parties of up to approximately $ 5.1 billion, including approximately $ 0.9 billion in development milestones, approximately $ 0.4 billion in regulatory milestones and approximately $ 3.8 billion in commercial milestones, as part of our various collaborations, including licensing and development programs.
+Added: Based on our development plans as of December 31, 2024, we could trigger potential future milestone payments to third parties of up to approximately $ 3.8 billion, including approximately $ 0.5 billion in development milestones, approximately $ 0.5 billion in regulatory milestones and approximately $ 2.8 billion in commercial milestones, as part
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: of our various collaborations, including licensing and development programs and HI-Bio's pre-existing commitments, as discussed below.
Payments under these agreements generally become due and payable upon achievement of certain development, regulatory or commercial milestones.
1 unchanged sentence
Amounts related to contingent milestone payments are not considered contractual obligations as they are contingent on the successful achievement of certain development, regulatory or commercial milestones.
−Removed: During the fourth quarter of 2023 we accrued a milestone payment due to Sage of $ 75.0 million upon the first commercial sale of ZURZUVAE for PPD in the U.S., which was recorded within intangible assets, net in our
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
−Removed: consolidated balance sheets, and subsequently paid in January 2024.
−Removed: If certain clinical and commercial milestones are met, we may pay up to approximately $ 109.0 million in milestones in 2024 under our current agreements.
−Removed: In June 2021 ADUHELM was granted accelerated approval by the FDA.
−Removed: Under the terms of the Neurimmune Agreement, we were required to pay Neurimmune a milestone payment of $ 100.0 million related to the launch of ADUHELM in the U.S.
−Removed: During the second quarter of 2021 we made this $ 100.0 million payment, which was recognized as a charge to net income (loss) attributable to noncontrolling interests, net of tax in our consolidated statements of income.
+Added: If certain clinical and commercial milestones are met, we may pay up to approximately $ 73.6 million in milestones in 2025 under our current agreements, excluding opt-in payments.
+Added: We acquired HI-Bio's pre-existing in-license commitments under third-party agreements, which include tiered royalties on potential future sales of felzartamab and izastobart/HIB210, ranging from high-single digit to mid-teen percentages, as well as potential future development, regulatory and commercial milestone payments related to felzartamab and izastobart/HIB210 of up to $ 130.0 million, $ 230.0 million and $ 640.0 million, respectively.
+Added: This amount includes potential milestone payments due upon the first patient dosed in a phase 3 clinical trial of felzartamab in a first and second indication of $ 35.0 million and $ 30.0 million, respectively.
Other Funding Commitments
8 unchanged sentences
As of December 31, 2024 and 2023, we have accrued income tax liabilities of approximately $ 234.0 million and $ 419.5 million, respectively, under the Transition Toll Tax.
−Removed: Of the amounts accrued as of December 31, 2023, approximately $ 185.4 million is expected to be paid within one year.
+Added: The amount accrued as of December 31, 2024, is expected to be paid within one year.
The Transition Toll Tax is being paid in installments over an eight--year period, which started in 2018, and will not accrue interest.
15 unchanged sentences
Participants may make voluntary contributions.
−Removed: We make matching contributions according to the 401(k) Savings Plan’s matching formula.
+Added: We make matching contributions according to the 401(k)
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: Savings Plan’s matching formula.
All matching contributions and participant contributions vest immediately.
3 unchanged sentences
Expense related to our 401(k) Savings Plan totaled approximately $ 51.5 million, $ 55.9 million and $ 56.0 million for the years ended December 31, 2024, 2023 and 2022, respectively.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Deferred Compensation Plan
22 unchanged sentences
Net periodic pension cost related to the German plans totaled $ 3.8 million, $ 3.6 million and $ 5.9 million for the years ended December 31, 2024, 2023 and 2022, respectively, of which $ 1.1 million, $ 0.8 million and $ 1.8 million, respectively, was included in other (income) expense, net in our consolidated statements of income.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Segment Information
−Removed: We operate as one operating segment, focused on discovering, developing and delivering worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies.
−Removed: Our CEO, as the CODM, manages and allocates resources to the operations of our company on a total company basis.
+Added: We operate and are managed as one operating segment, and derive revenue from activities related to the discovery, development and delivery of innovative therapies for people living with serious and complex diseases.
Our research and development organization is responsible for the research and discovery of new product candidates and supports development and registration efforts for potential future products.
2 unchanged sentences
and international development of our commercial products.
−Removed: The company is also supported by corporate staff functions.
−Removed: Managing and allocating resources on a total company basis enables our CEO to assess the overall level of resources available and how to best deploy these resources across functions, therapeutic areas and research and development projects that are in line with our long-term company-wide strategic goals.
−Removed: Consistent with this decision-making process, our CEO uses consolidated, single-segment financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets.
−Removed: Enterprise-wide disclosures about product revenue, other revenue and long-lived assets by geographic area are presented below.
+Added: We are also supported by corporate staff functions.
+Added: Our CEO, as the CODM, manages and allocates resources to the operations of our company on a total company basis by assessing the overall level of resources available and how to best deploy these resources across functions, therapeutic areas and research and development projects that are in line with our long-term company-wide strategic goals.
+Added: In making these decisions, our CEO uses consolidated financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: CODM performs this assessment based on the segment’s net income.
+Added: Through this analysis, which includes a comparison to budgeted results, the CODM assesses performance and how to allocate resources across the functions discussed above.
+Added: The measure of segment assets used in determining how to manage and allocate resources is reported within our consolidated balance sheets as total assets.
+Added: The tables presented below, which were prepared in accordance with the accounting policies discussed in Note 1, Summary of Significant Accounting Policies , contain additional information on enterprise-wide disclosures about product revenue, other revenue and long-lived assets, as well as our segment’s revenue and profits, including significant segment expense and other segment items.
Revenue is primarily attributed to individual countries based on location of the customer or licensee.
26 unchanged sentences
For additional information on our Solothurn manufacturing facility, please read Note 11, Property, Plant and Equipment, to these consolidated financial statements.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
+Added: Additional Segment Information
+Added: The following table includes additional information about reported segment revenue, significant segment expense and segment measure of profitability:
+Added: For the Years Ended December 31,
+Added: (In millions) 2024 2023 2022
+Added: Total revenue $ 9,675.9 $ 9,835.6 $ 10,173.4
+Added: Less cost and expense:
+Added: Cost of sales, excluding amortization and impairment of acquired intangible assets:
+Added: Product cost of sales 1,604.2 1,787.2 1,504.8
+Added: Royalty cost of sales 706.2 746.2 773.5
+Added: Research and development:
+Added: Milestone and upfront expense 61.5 16.6 76.2
+Added: Research and discovery 201.5 212.5 289.4
+Added: Early stage programs 286.6 361.0 289.9
+Added: Late stage programs 209.7 250.5 484.5
+Added: Marketed products 534.7 766.1 361.5
+Added: Other research and development costs (1)
+Added: 747.8 855.3 729.6
+Added: Selling, general and administrative 2,403.7 2,549.7 2,403.6
+Added: Other segment expense (2)
+Added: 1,287.8 1,129.4 213.5
+Added: Net Income attributable to Biogen Inc.
+Added: $ 1,632.2 $ 1,161.1 $ 3,046.9
+Added: (1) Other research and development costs primarily consist of indirect costs incurred in support of overall research and development activities and non-specific programs, including activities that benefit multiple programs, such as management costs, as well as depreciation, information technology and facility-based expenses and are not allocated to a specific program or stage.
+Added: (2) Other segment expense includes:
+Added: amortization and impairment of acquired intangible assets;
+Added: collaboration profit sharing/(loss reimbursement);
+Added: (gain) loss on fair value remeasurement of contingent consideration;
+Added: restructuring charges;
+Added: gain on sale of priority review voucher, net;
+Added: gain on sale of building, net;
+Added: other (income) expense, net;
+Added: income tax (benefit) expense;
+Added: equity in (income) loss of investee, net of tax;
+Added: and net income (loss) attributable to noncontrolling interests, net of tax.
+Added: Subsequent Events
+Added: In February 2025 we entered into an arrangement with Royalty Pharma under which we will receive up to $ 200.0 million in 2025 and up to $ 50.0 million in 2026 to co-fund our development costs for the litifilimab program.
+Added: Following potential regulatory approval, Royalty Pharma will be eligible for regulatory milestones and royalties of a mid-single digits percentage of the applicable net sales.
Report of Independent Registered Public Accounting Firm
19 unchanged sentences
We believe that our audits provide a reasonable basis for our opinions.
−Removed: As described in Management’s Annual Report on Internal Control over Financial Reporting, management has excluded Reata Pharmaceuticals, Inc.
−Removed: (Reata) from its assessment of internal control over financial reporting as of December 31, 2023, because it was acquired by the Company in a purchase business combination during 2023.
−Removed: We have also excluded Reata from our audit of internal control over financial reporting.
−Removed: Reata is a wholly-owned subsidiary whose total assets and total revenue excluded from management’s assessment and our audit of internal control over financial reporting represent 1.0% and 0.6%, respectively, of the related consolidated financial statement amounts as of and for the year ended December 31, 2023.
Definition and Limitations of Internal Control over Financial Reporting
−Removed: A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in
−Removed: accordance with generally accepted accounting principles.
+Added: A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;
−Removed: (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company;
+Added: (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made
+Added: only in accordance with authorizations of management and directors of the company;
and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
19 unchanged sentences
The principal considerations for our determination that performing procedures relating to reserves for Medicaid and managed care rebates in the U.S.
−Removed: is a critical audit matter are (i) the significant judgment by management due to the significant measurement uncertainty when developing the estimate of the reserves and (ii) a high degree of auditor judgment, subjectivity, and effort in performing procedures and evaluating assumptions related to historical experience, current contractual requirements, specific known market events, and forecasted customer buying and payment patterns.
+Added: is a critical audit matter are (i) the significant judgment by management due to the significant measurement uncertainty when developing the estimate of the reserves and (ii) a high degree of auditor judgment, subjectivity, and effort in performing procedures and evaluating management's significant assumptions related to historical experience, current contractual requirements, specific known market events, and forecasted customer buying and payment patterns.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements.
4 unchanged sentences
and (iii) testing, on a sample basis, rebate claims paid by the Company, including evaluating the claims for consistency with the contractual terms of the Company’s rebate agreements.
−Removed: Acquisition of Reata - Valuation of Completed Technology and In-Process Research and Development Intangible Assets
−Removed: As described in Notes 1 and 2 to the consolidated financial statements, the Company completed the acquisition of Reata for total consideration of $7,193.4 million.
−Removed: Of the acquired intangible assets, $4,200.0 million of completed technology and $2,300.0 million of in-process research and development (IPR&D) were recorded.
+Added: Acquisition of Human Immunology Biosciences, Inc.
+Added: (HI-Bio) - Valuation of In-Process Research and Development Intangible Assets
+Added: As described in Notes 1 and 2 to the consolidated financial statements, on July 2, 2024, the Company completed the acquisition of HI-Bio for total consideration of $1,622.4 million.
+Added: In-process research and development (IPR&D) intangible assets of $1,635.0 million were recorded, which include $920.0 million related to felzartamab indication for immunoglobulin A.
+Added: nephropathy (IgAN), $450.0 million related to felzartamab indication for antibody-mediated rejection (AMR), and $265.0 million related to felzartamab indication for primary membranous nephropathy (PMN).
Management uses the multi-period excess earnings method, which is a form of the income approach, utilizing post-tax cash flows and discount rates in estimating the fair value of identifiable intangible assets acquired when allocating the purchase consideration paid for the acquisition.
−Removed: The estimates of the fair value of identifiable intangible assets involve significant judgment by management and include assumptions with measurement uncertainty, such as the amount and timing of projected cash flows, long-term sales forecasts, discount rate, and additionally for the IPR&D intangible asset, the timing and probability of regulatory and commercial success.
−Removed: The principal considerations for our determination that performing procedures relating to the valuation of completed technology and IPR&D intangible assets acquired in the acquisition of Reata is a critical audit matter are (i) the significant judgment by management due to the significant measurement uncertainty when developing the fair value estimate of the completed technology and IPR&D intangible assets acquired;
−Removed: (ii) a high degree of auditor judgment, subjectivity, and effort in performing procedures and evaluating management’s significant assumptions related to long-term sales forecasts and discount rate for the completed technology intangible asset and long-term sales forecasts, discount rate, and probability of regulatory and commercial success for the IPR&D intangible asset;
+Added: The estimates of the fair value of identifiable intangible assets involve significant judgment by management and include assumptions with measurement uncertainty, such as the amount and timing of projected cash flow, long-term sales forecasts, discount rates, and the timing and probability of regulatory and commercial success.
+Added: The principal considerations for our determination that performing procedures relating to the valuation of IPR&D intangible assets acquired in the acquisition of HI-Bio is a critical audit matter are (i) the significant judgment by management due to the significant measurement uncertainty when developing the fair value estimate of the IPR&D intangible assets acquired;
+Added: (ii) a high degree of auditor judgment, subjectivity, and effort in performing procedures and evaluating management’s significant assumptions related to long-term sales forecasts, discount rate, and the probability of regulatory and commercial success for the IPR&D intangible assets acquired;
and (iii) the audit effort involved the use of professionals with specialized skill and knowledge.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements.
−Removed: These procedures included testing the effectiveness of controls relating to the acquisition accounting, including controls over management’s valuation of the completed technology and IPR&D intangible assets acquired.
+Added: These procedures included testing the effectiveness of controls relating to the acquisition accounting, including controls over management’s valuation of the IPR&D intangible assets acquired.
These procedures also included, among others (i) reading the purchase agreement;
−Removed: (ii) testing management’s process for developing the fair value estimate of the completed technology and IPR&D intangible assets acquired;
+Added: (ii) testing management’s process for developing the fair value estimate of the IPR&D intangible assets acquired;
(iii) evaluating the appropriateness of the multi-period excess earnings method used by management;
(iv) testing the completeness and accuracy of certain of the data used in the multi-period excess earnings method;
−Removed: and (v) evaluating the reasonableness of the significant assumptions used by management related to long-term sales forecasts and discount rate for the completed technology intangible asset and long-term sales forecasts, discount rate, and probability of regulatory and commercial success for the IPR&D intangible asset.
−Removed: Evaluating management’s assumptions related to long-term sales forecasts for the completed technology and IPR&D intangible assets and probability of regulatory and commercial success for the IPR&D intangible asset involved evaluating whether the assumptions used by management were reasonable considering (i) the current and past performance of the acquired business and (ii) whether the assumptions were consistent with evidence obtained in other areas of the audit.
+Added: and (v) evaluating the reasonableness of the significant assumptions used by management related to long-term sales forecasts, discount rate, and the probability of regulatory and commercial success for the IPR&D intangible assets acquired.
+Added: Evaluating management's assumptions related to long-term sales forecasts and the probability of regulatory and commercial success for the IPR&D intangible assets acquired involved evaluating whether the assumptions used by management were reasonable considering (i) the current and past performance of the acquired business and (ii) whether the assumptions were consistent with evidence obtained in other areas of the audit.
Evaluating management’s assumption related to long-term sales forecasts also involved considering the consistency with external market and industry data.
−Removed: Professionals with specialized skill and knowledge were used to assist in evaluating (i) the appropriateness of the multi-period excess earnings method and (ii) the reasonableness of the discount rate significant assumption for the completed technology and IPR&D intangible assets.
+Added: Professionals with specialized skill and knowledge were used to assist in evaluating (i) the appropriateness of the multi-period excess earnings method and (ii) the reasonableness of the discount rate significant assumption for the IPR&D intangible assets acquired.
/s/ PricewaterhouseCoopers LLP
3 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.