What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2024-08-01 compared with 2024-05-02 · 184 added, 127 removed, 562 unchanged (36% of the section changed)

3 unchanged sentences

(In millions, except per share data)

March 31, December 31,

June 30, December 31,

Current assets:

45 unchanged sentences

Three Months Ended

Six Months Ended

Statements of Operations

10 unchanged sentences

14.6 ( 0.6 ) 29.9 ( 1.1 )

2,477.5 2,141.6 4,871.1 4,357.0

Income from operations 1,069.6 1,016.5 1,821.0 1,963.2

Other income (expense):

Other (expense) income, net

Other income (expense), net

573.3 85.3 538.7 14.6

2 unchanged sentences

Income before income taxes 1,628.1 1,082.9 2,328.8 1,940.9

Income tax (benefit) expense

Income tax expense

195.8 114.5 174.5 154.7

7 unchanged sentences

Other comprehensive income (loss), net of tax:

Unrealized gain on debt securities

Gain on foreign currency translation

Unrealized gain (loss) on debt securities

7.9 ( 15.7 ) 11.4 41.5

Loss on foreign currency translation

( 0.6 ) ( 0.4 ) ( 0.4 ) ( 0.4 )

Comprehensive income $ 1,439.6 $ 952.3 $ 2,165.3 $ 1,827.3

18 unchanged sentences

1.8 — 134.2 0.1 11,942.6 27,982.3 ( 77.2 ) ( 25.8 ) ( 12,856.7 ) 26,991.1

Balance, December 31, 2022

1.8 $ — 130.4 $ 0.1 $ 9,949.3 $ 23,306.7 $ ( 238.8 ) ( 22.6 ) $ ( 10,353.3 ) $ 22,664.0

Issuance of Common Stock for equity awards granted under long-term incentive plans — — 1.0 — 436.5 — — — — 436.5

Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.4 ) — ( 311.8 ) — — — — ( 311.8 )

Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 19.6 — — — 2.2 21.8

Repurchases of Common Stock — — — — — — — ( 0.6 ) ( 601.4 ) ( 601.4 )

Stock-based compensation charges — — — — 230.0 — — — — 230.0

Net income — — — — — 1,432.3 — — — 1,432.3

Other comprehensive income, net of tax

— — — — — — 7.3 — — 7.3

Balance, June 30, 2024

1.8 $ — 134.8 $ 0.1 $ 12,316.9 $ 29,414.6 $ ( 69.9 ) ( 26.4 ) $ ( 13,455.9 ) $ 28,205.8

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) (continued)

Class A Stock Common Stock Additional

Paid-in Capital Retained Earnings Accumulated Other Comprehensive Income (Loss) Treasury Stock Total Stockholders' Equity

Shares Amount Shares Amount Shares Amount

Balance, December 31, 2022 1.8 $ — 130.4 $ 0.1 $ 9,949.3 $ 23,306.7 $ ( 238.8 ) ( 22.6 ) $ ( 10,353.3 ) $ 22,664.0

Issuance of Common Stock for equity awards granted under long-term incentive plans — — 1.1 — 491.3 — — — — 491.3

Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.1 ) — ( 99.2 ) — — — — ( 99.2 )

7 unchanged sentences

1.8 — 131.4 0.1 10,597.7 24,124.5 ( 181.6 ) ( 23.5 ) ( 11,045.5 ) 23,495.2

Issuance of Common Stock for equity awards granted under long-term incentive plans — — 0.2 — 80.7 — — — — 80.7

Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — — — ( 14.0 ) — — — — ( 14.0 )

Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 16.1 — — — 2.4 18.5

Repurchases of Common Stock — — — — — — — ( 1.0 ) ( 722.8 ) ( 722.8 )

Stock-based compensation charges — — — — 208.0 — — — — 208.0

Net income — — — — — 968.4 — — — 968.4

Other comprehensive loss, net of tax

— — — — — — ( 16.1 ) — — ( 16.1 )

Balance, June 30, 2023

1.8 $ — 131.6 $ 0.1 $ 10,888.5 $ 25,092.9 $ ( 197.7 ) ( 24.5 ) $ ( 11,765.9 ) $ 24,017.9

The accompanying notes are an integral part of the financial statements.

2 unchanged sentences

(In millions)

Three Months Ended

Six Months Ended

Cash flows from operating activities:

3 unchanged sentences

Stock-based compensation expense 453.3 440.7

Losses on marketable and other securities, net 196.1 166.6

(Gains) losses on marketable and other securities, net

( 196.5 ) 197.5

Other non-cash items, net ( 2.9 ) 29.2

1 unchanged sentence

Changes in assets and liabilities:

Decrease in accounts receivable

(Increase) decrease in accounts receivable

( 47.3 ) 207.4

Increase in inventories ( 337.6 ) ( 147.2 )

1 unchanged sentence

Increase (decrease) in deferred revenue 206.0 ( 50.4 )

116.9 ( 35.9 )

Increase in accounts payable, accrued expenses, and other liabilities 315.1 158.7

5 unchanged sentences

Capital expenditures ( 314.4 ) ( 291.2 )

Proceeds from sale of property, plant, and equipment

Payments for Libtayo intangible asset ( 58.3 ) ( 121.8 )

Acquisitions, net of cash acquired

Net cash used in investing activities ( 2,244.3 ) ( 2,622.6 )

3 unchanged sentences

Repurchases of Common Stock ( 895.2 ) ( 1,399.5 )

Net cash provided by (used in) financing activities

Net cash used in financing activities

( 431.0 ) ( 936.7 )

Effect of exchange rate changes on cash, cash equivalents, and restricted cash ( 0.8 ) ( 0.4 )

Net (decrease) increase in cash, cash equivalents, and restricted cash ( 128.0 ) 809.4

Net decrease in cash, cash equivalents, and restricted cash

( 809.6 ) ( 1,169.7 )

Cash, cash equivalents, and restricted cash at beginning of period 2,737.8 3,119.4

27 unchanged sentences

Three Months Ended

June 30, Six Months Ended

(In millions) 2024 2023 2024 2023

$ 304.2 $ — $ 504.2 $ —

1,230.5 1,500.1 2,432.1 2,933.9

Total EYLEA HD and EYLEA U.S.

1,534.7 1,500.1 2,936.3 2,933.9

182.4 130.2 341.6 239.9

Rest of world

115.0 79.8 219.7 147.0

Total Libtayo

297.4 210.0 561.3 386.9

(a) Rest of world ("ROW")

As of March 31, 2024 and December 31, 2023, the Company had $ 3.739 billion and $ 3.888 billion, respectively, of trade accounts receivable that were recorded within Accounts receivable, net.

The Company had product sales to certain customers that accounted for more than 10% of total gross product revenue for the three months ended March 31, 2024 and 2023.

56.1 40.5 126.1 80.7

30.4 19.3 55.2 34.2

— 2.2 1.0 4.4

$ 1,918.6 $ 1,772.1 $ 3,679.9 $ 3,440.1

As of June 30, 2024 and December 31, 2023, the Company had $ 3.958 billion and $ 3.888 billion, respectively, of trade accounts receivable that were recorded within Accounts receivable, net.

The Company had product sales to certain customers that each accounted for more than 10% of total gross product revenue for the three and six months ended June 30, 2024 and 2023.

Sales to each of these customers as a percentage of the Company's total gross product revenue are as follows:

Three Months Ended

Six Months Ended

2024 2023 2024 2023

Besse Medical, a subsidiary of Cencora, Inc.

51 % 51 % 51 % 51 %

McKesson Corporation 24 % 25 % 24 % 25 %

4 unchanged sentences

however, the Company is only required to apply 20 % of its share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses.

As of March 31, 2024, the Company's contingent reimbursement obligation to Sanofi under the collaboration was approximately $ 2.200 billion.

As of June 30, 2024, the Company's contingent reimbursement obligation to Sanofi under the collaboration was approximately $ 2.013 billion.

Sanofi leads commercialization activities for products under the collaboration, subject to the Company's right to co-commercialize such products.

1 unchanged sentence

Statement of Operations Classification Three Months Ended

Six Months Ended

(In millions) 2024 2023 2024 2023

Regeneron's share of profits in connection with commercialization of antibodies Collaboration revenue $ 804.0 $ 636.5

Regeneron's share of profits

Collaboration revenue $ 988.3 $ 751.1 $ 1,792.3 $ 1,387.6

Reimbursement for manufacturing of commercial supplies Collaboration revenue $ 157.3 $ 192.6 $ 263.1 $ 354.5

3 unchanged sentences

The following table summarizes contract balances in connection with the Company's Sanofi collaboration:

March 31, December 31,

June 30, December 31,

(In millions) 2024

8 unchanged sentences

Statement of Operations Classification Three Months Ended

Six Months Ended

(In millions) 2024 2023 2024 2023

Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States

Regeneron's share of profits

Collaboration revenue $ 353.0 $ 349.5 $ 686.9 $ 681.1

4 unchanged sentences

The following table summarizes contract balances in connection with the Company's Bayer collaboration:

March 31, December 31,

June 30, December 31,

(In millions) 2024

2 unchanged sentences

$ 171.1 $ 138.2

The Company is party to a collaboration agreement with Alnylam Pharmaceuticals, Inc.

to discover, develop, and commercialize RNA interference therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system, in addition to a select number of targets expressed in the liver.

For each program, the Company provides Alnylam with a specified amount of funding at program initiation and at lead candidate designation.

Under the terms of the collaboration, the parties perform discovery research until designation of lead candidates.

Following designation of a lead candidate, the parties may further advance such lead candidate under either a co-development/co-commercialization collaboration agreement or license agreement.

Amounts recognized in the Company's Statements of Operations in connection with its Alnylam collaboration are as follows:

Statement of Operations Classification Three Months Ended

(In millions) 2024

Regeneron's obligation for its share of Alnylam R&D expenses, net of reimbursement of R&D expenses

(R&D expense)

$ ( 17.5 ) $ ( 21.3 )

The following table summarizes contract balances in connection with the Company's Alnylam collaboration:

March 31, December 31,

(In millions) 2024

Accrued expenses and other current liabilities

$ 18.9 $ 22.6

The Company is a party to a collaboration agreement with Roche to develop, manufacture, and distribute the casirivimab and imdevimab antibody cocktail (known as REGEN-COV ® in the United States and Ronapreve ™ in other countries).

Under the terms of the collaboration agreement, the parties jointly fund certain studies, and the Company has the right to distribute the product in the United States while Roche has the right to distribute the product outside the United States.

Under the terms of the collaboration agreement, the Company has the right to distribute the product in the United States while Roche has the right to distribute the product outside the United States.

The parties share gross profits from worldwide sales based on a pre-specified formula, depending on the amount of manufactured product supplied by each party to the market.

1 unchanged sentence

Statement of Operations Classification Three Months Ended

Six Months Ended

(In millions) 2024 2023 2024

Global gross profit payment from Roche in connection with sales of Ronapreve Collaboration revenue $ 0.4 $ — $ 0.9 $ 222.2

Reimbursement of research and development expenses from Roche was not material for the three months ended March 31, 2024 and 2023.

Contract balances in the Company's Balance Sheets in connection with the Roche collaboration were not material as of March 31, 2024 and December 31, 2023.

In March 2023, the Company and Sonoma Biotherapeutics, Inc.

entered into a license and collaboration agreement to bring together the Company's VelociSuite ® technologies with Sonoma's technology platform for the discovery, development, and commercialization of novel regulatory T cell ("T reg ") therapies for autoimmune diseases.

In connection with the agreement, the Company made a $ 45.0 million up-front payment (which was recorded to Acquired in-process research and development expense in the first quarter of 2023) and, in April 2023, the Company purchased an aggregate of $ 30.0 million of Sonoma preferred stock.

Sonoma is also eligible to receive a $ 45.0 million development milestone payment.

The parties co-fund research and development activities under the collaboration.

Amounts recognized in the Company's Statements of Operations in connection with research and development activities co-funded under the Sonoma collaboration were not material for the three months ended March 31, 2024.

In addition, contract balances in the Company's Balance Sheets in connection with the Sonoma collaboration were not material as of March 31, 2024 and December 31, 2023.

Collaboration revenue $ — $ ( 3.8 ) $ — $ ( 3.8 )

Contract balances in the Company's Balance Sheets in connection with the Roche collaboration were not material as of June 30, 2024 and December 31, 2023.

In addition to the collaboration and license agreements discussed above, the Company has various other collaboration and license agreements that are not individually significant to its operating results or financial condition at this time.

Pursuant to the terms of those agreements, the Company may be required to pay, or it may receive, additional amounts contingent upon the occurrence of various future events (e.g., upon the achievement of various development and commercial milestones), which in the aggregate could be significant.

The Company may also incur, or get reimbursed for, significant research and development costs.

During the three and six months ended June 30, 2024, the Company recorded to Acquired in-process research and development expense $ 23.9 million and $ 31.0 million, respectively, which primarily related to up-front payments, as well as a premium on equity securities purchased, in connection with collaboration and licensing agreements.

During the six months ended June 30, 2023, the Company recorded to Acquired in-process research and development expense $ 56.1 million, which included a $ 45.0 million u p-front payment in connection with the Company's collaboration agreement with Sonoma Biotherapeutics, Inc.

Net Income Per Share

4 unchanged sentences

Three Months Ended

Six Months Ended

(In millions, except per share data) 2024 2023 2024 2023

9 unchanged sentences

Three Months Ended

Six Months Ended

(Shares in millions) 2024 2023 2024 2023

1 unchanged sentence

Marketable Securities

Marketable securities as of March 31, 2024 and December 31, 2023 consist of both available-for-sale debt securities of investment grade issuers (see below and Note 6) as well as equity securities of publicly traded companies (see Note 6).

Marketable securities as of June 30, 2024 and December 31, 2023 consist of both available-for-sale debt securities of investment grade issuers (see below and Note 6) as well as equity securities of publicly traded companies (see Note 6).

The following tables summarize the Company's investments in available-for-sale debt securities:

(In millions) Amortized Unrealized Fair

As of March 31, 2024

As of June 30, 2024

Cost Basis Gains Losses Value

15 unchanged sentences

The Company classifies its investments in available-for-sale debt securities based on their contractual maturity dates.

The available-for-sale debt securities as of March 31, 2024 mature at various dates through June 2029.

The available-for-sale debt securities as of June 30, 2024 mature at various dates through June 2029.

The fair values of available-for-sale debt securities by contractual maturity consist of the following:

March 31, December 31,

June 30, December 31,

(In millions) 2024

6 unchanged sentences

(In millions)

As of March 31, 2024

As of June 30, 2024

Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss

3 unchanged sentences

Commercial paper 784.9 ( 0.4 ) — — 784.9 ( 0.4 )

Certificates of deposit

384.3 ( 0.1 ) — — 384.3 ( 0.1 )

Asset-backed securities 81.7 ( 0.2 ) 68.8 ( 0.9 ) 150.5 ( 1.1 )

8 unchanged sentences

$ 7,854.9 $ ( 9.0 ) $ 4,157.5 $ ( 106.8 ) $ 12,012.4 $ ( 115.8 )

The unrealized losses on corporate bonds as of March 31, 2024 were primarily driven by increased interest rates.

The unrealized losses on corporate bonds as of June 30, 2024 were primarily driven by increased interest rates.

The Company has reviewed its portfolio of available-for-sale debt securities and determined that the decline in fair value below cost did not result from credit-related factors.

In addition, the Company does not intend to sell, and it is not more likely than not that the Company will be required to sell, such securities before recovery of their amortized cost bases.

With respect to marketable securities, for the three months ended March 31, 2024 and 2023, amounts reclassified from Accumulated other comprehensive loss into Other (expense) income, net were related to realized gains/losses on sales of available-for-sale debt securities.

For the three months ended March 31, 2024 and 2023, realized gains/losses on sales of marketable securities were not material .

With respect to marketable securities, for the three and six months ended June 30, 2024 and 2023, amounts reclassified from Accumulated other comprehensive loss into Other income (expense), net were related to realized gains/losses on sales of available-for-sale debt securities.

For the three and six months ended June 30, 2024 and 2023, realized gains/losses on sales of marketable securities were not material.

Fair Value Measurements

5 unchanged sentences

(In millions) Fair Value Measurements at Reporting Date

As of March 31, 2024

As of June 30, 2024

Fair Value Level 1 Level 2 Level 3

26 unchanged sentences

$ 43.7 $ — $ — $ 43.7

As of March 31, 2024, the Company held restricted equity securities which are subject to transfer restrictions that expire in June 2024.

During the three months ended March 31, 2024 and 2023, the Company recorded $ 196.2 million and $ 164.7 million, respectively, of net unrealized losses on equity securities in Other (expense) income, net.

In addition to the investments summarized in the table above, as of March 31, 2024 and December 31, 2023, the Company had $ 73.7 million and $ 74.3 million, respectively, in equity investments that do not have a readily determinable fair value.

The Company held certain restricted equity securities as of June 30, 2024 which are subject to transfer restrictions that expire in April 2026.

During the three and six months ended June 30, 2024, the Company recorded $ 392.5 million and $ 196.3 million of net unrealized gains, respectively, on equity securities in Other income (expense), net;

and during the three and six months ended June 30, 2023, the Company recorded $ 30.9 million and $ 195.6 million of net unrealized losses, respectively, on equity securities in Other income (expense), net.

In addition to the investments summarized in the table above, as of June 30, 2024 and December 31, 2023, the Company had $ 196.8 million and $ 74.3 million, respectively, in equity investments that do not have a readily determinable fair value.

These investments are recorded within Other noncurrent assets.

As a result of the Company's acquisition of Decibel Therapeutics, Inc.

in September 2023, the Company recorded a contingent consideration liability within other liabilities.

The fair value of the liability is determined based on the probability of achieving certain clinical development and regulatory milestones and estimated discount rates, and is remeasured each reporting period until the contingencies are resolved.

During the three months ended March 31, 2024, the Company recorded a $ 15.3 million charge related to the change in the estimated fair value of the contingent consideration liability within Other operating expense (income), net.

The fair value of the Company's long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.497 billion and $ 1.528 billion as of March 31, 2024 and December 31, 2023, respectively.

The fair value of the Company's long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.485 billion and $ 1.528 billion as of June 30, 2024 and December 31, 2023, respectively.

Inventories consist of the following:

8 unchanged sentences

federal, state, and foreign income taxes.

The Company's effective tax rate was ( 3.0 %) and 4.7 % for the three months ended March 31, 2024 and 2023, respectively.

The Company's effective tax rate for the three months ended March 31, 2024 and 2023 was positively impacted, compared to the U.S.

The Company's effective tax rate was 12.0 % and 10.6 % for the three months ended June 30, 2024 and 2023, respectively, and 7.5 % and 8.0 % for the six months ended June 30, 2024 and 2023, respectively.

The Company's effective tax rate for the three and six months ended June 30, 2024 was positively impacted, compared to the U.S.

federal statutory rate, primarily by stock-based compensation and income earned in foreign jurisdictions with tax rates lower than the U.S.

federal statutory rate.

The effective tax rate for the three months ended March 31, 2024 was positively impacted, compared to the same period in 2023, primarily by additional stock-based compensation.

federal statutory rate, partly offset by the remeasurement of existing uncertain tax positions.

The Company's effective tax rate for the three and six months ended June 30, 2023 was positively impacted, compared to the U.S.

federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S.

federal statutory rate and, to a lesser extent, stock-based compensation and federal tax credits for research activities.

Stockholders' Equity

In November 2021, the Company's board of directors authorized a share repurchase program to repurchase up to $ 3.0 billion of the Company's Common Stock.

As of June 30, 2023, the Company had repurchased the entire $ 3.0 billion of its Common Stock that it was authorized to repurchase under the program.

In January 2023, the Company's board of directors authorized an additional share repurchase program to repurchase up to $ 3.0 billion of the Company's Common Stock.

In January 2023, the Company's board of directors authorized a share repurchase program to repurchase up to $ 3.0 billion of the Company's Common Stock.

The share repurchase program permits the Company to make repurchases through a variety of methods, including open-market transactions (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act.

2 unchanged sentences

There can be no assurance as to the timing or number of shares of any repurchases in the future.

As of March 31, 2024, $ 1.233 billion remained available for share repurchases under the program.

In April 2024, the Company's board of directors authorized a share repurchase program to repurchase up to an additional $ 3.0 billion of the Company's Common Stock.

The share repurchase program was approved under terms substantially similar to the share repurchase program described above.

The table below summarizes the shares of the Company's Common Stock the Company repurchased and the cost of the shares, which were recorded as Treasury Stock.

Three Months Ended

Six Months Ended

(In millions) 2024 2023

1 unchanged sentence

Total cost of shares $ 601.4 $ 722.8 $ 899.4 $ 1,416.7

In April 2024, the Company's board of directors authorized a new share repurchase program to repurchase up to an additional $ 3.0 billion of the Company's Common Stock.

The share repurchase program was approved under terms substantially similar to the share repurchase programs described above.

As of June 30, 2024, an aggregate of $ 3.631 billion remained available for share repurchases under the programs.

Statement of Cash Flows

2 unchanged sentences

Cash and cash equivalents $ 1,920.7 $ 1,937.2

Restricted cash included in Prepaid expenses and other current assets 7.5 5.5

Restricted cash included in Other noncurrent assets

3 unchanged sentences

Supplemental disclosure of non-cash investing and financing activities

March 31, December 31, March 31, December 31,

June 30, December 31, June 30, December 31,

(In millions) 2024

8 unchanged sentences

The Company recognizes accruals for loss contingencies associated with such proceedings when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated.

As of March 31, 2024 and December 31, 2023, the Company's accruals for loss contingencies were not material.

As of June 30, 2024 and December 31, 2023, the Company's accruals for loss contingencies were not material.

There are certain loss contingencies that the Company deems reasonably possible for which the possible loss or range of possible loss is not estimable at this time.

9 unchanged sentences

and, as part of its response, on September 20, 2023, Amgen filed a counterclaim alleging that the Company engaged in unfair business practices in violation of state law.

On May 22, 2024, Amgen filed a motion for summary judgment.

A trial has been scheduled to begin in November 2024.

On June 1, 2023, Amgen filed a lawsuit against the Company and certain of Sanofi's affiliated entities in the Munich Local Division of the Unified Patent Court (the "UPC") alleging infringement of Amgen's European Patent No.

On June 1, 2023, Sanofi filed an action in the Munich Central Division of the Unified Patent Court (the "UPC") seeking revocation of Amgen's European Patent No.

3,666,797 (the "'797 Patent").

The lawsuit seeks, among other things, a permanent injunction in several countries in Europe and monetary damages.

The '797 Patent is a divisional patent of European Patent No.

2,215,124 (the "'124 Patent") (i.e., a patent that shares the same priority date, disclosure, and patent term of the parent '124 Patent), which was previously invalidated by Technical Board of Appeal (the "TBA") of the European Patent Office (the "EPO").

A trial has been scheduled for October 16–17, 2024.

Also on June 1, 2023, Sanofi filed an action in the Munich Central Division of the UPC seeking revocation of the '797 Patent.

A trial has been scheduled for June 4–5, 2024.

A trial on the revocation action before the Munich Central Division of the UPC was held on June 4, 2024.

On July 16, 2024, the Munich Central Division of the UPC issued a decision revoking the '797 Patent in its entirety.

Also on June 1, 2023, Amgen filed a lawsuit against the Company and certain of Sanofi's affiliated entities in the Munich Local Division of the UPC alleging infringement of the '797 Patent.

The lawsuit seeks, among other things, a permanent injunction in several countries in Europe and monetary damages.

On July 29, 2024, the Munich Local Division of the UPC ordered a stay of the infringement lawsuit in light of the decision of the Munich Central Division of the UPC to revoke the '797 Patent in its entirety (discussed above).

Proceedings Relating to EYLEA (aflibercept) Injection

12 unchanged sentences

On January 10, 2023, the Company filed notices of appeal of these decisions to the United States Court of Appeals for the Federal Circuit (the "Federal Circuit").

On July 9, 2024, the Company's appeal was voluntarily dismissed.

10,130,681 (the "'681 Patent") and 10,888,601 (the "'601 Patent")

9 unchanged sentences

On July 19, 2023 and October 20, 2023, the USPTO instituted IPR proceedings concerning the '681 Patent and the '601 Patent, respectively.

On June 14, 2024, the USPTO issued a final written decision finding that the challenged claims of the '681 Patent are unpatentable and, therefore, invalid.

11,253,572 (the "'572 Patent") Samsung Bioepis

2 unchanged sentences

On November 17, 2023, the USPTO instituted IPR proceedings concerning the '572 Patent.

On July 11, 2024, the Company filed a Notice of Disclaimer with the USPTO, disclaiming all claims of the '572 Patent.

Patent Litigation

5 unchanged sentences

11,084,865 (the "'865 Patent").

On December 27, 2023, the court issued a decision finding that (i) the asserted claims of the '865 Patent were valid and infringed by Mylan and (ii) the asserted claims of the '601 and '572 Patents were infringed by Mylan but were invalid as obvious.

A scheduling conference has been set for May 17, 2024.

On December 27, 2023, the court issued a decision finding that (i) the asserted claims of the '865 Patent were valid and infringed by Mylan and Biocon and (ii) the asserted claims of the '601 and '572 Patents were infringed by Mylan and Biocon but were invalid as obvious.

On June 11, 2024, the court granted the Company's motion for a permanent injunction, enjoining Mylan and Biocon from selling in the United States their aflibercept 2 mg biosimilar until the expiration of the '865 Patent.

On June 21, 2024, Mylan and Biocon filed a notice of appeal of the court's December 27, 2023 and June 11, 2024 decisions to the Federal Circuit.

On November 8, November 22, and November 29, 2023, respectively, the Company filed patent infringement lawsuits against Celltrion, Samsung Bioepis, and Formycon AG in the United States District Court for the Northern District of West Virginia following service on Regeneron of each company's notice of commercial marketing.

1 unchanged sentence

On December 27, 2023, the Company filed a second patent infringement lawsuit against Samsung Bioepis in the United States District Court for the Northern District of West Virginia alleging that Samsung's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents.

A scheduling conference has been set for May 17, 2024.

On June 14, June 21, and June 28, 2024, respectively, the court granted the Company's motions for preliminary injunctions against Samsung Bioepis, Formycon, and Celltrion.

On June 14, June 25, and July 8, 2024, respectively, Samsung Bioepis, Formycon, and Celltrion filed notices of appeal of the court's preliminary injunction decisions to the Federal Circuit.

On January 10, 2024, the Company filed a patent infringement lawsuit against Amgen in the United States District Court for the Central District of California alleging that Amgen's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents.

On January 11, 2024, the Company filed a motion with the United States Judicial Panel on Multidistrict Litigation seeking to transfer this lawsuit to the United States District Court for the Northern District of West Virginia for coordinated pretrial proceedings with the lawsuits described in the preceding paragraph.

On April 11, 2024, the United States Judicial Panel on Multidistrict Litigation granted the Company's motion to transfer this lawsuit to the United States District Court for the Northern District of West Virginia for coordinated and consolidated pretrial proceedings with the lawsuits

described in the preceding paragraph.

A scheduling conference before the United States District Court for the Northern District of West Virginia has been set for May 17, 2024.

On June 7, 2024, the Company filed a motion for a preliminary injunction against Amgen.

An oral hearing before the United States District Court for the Northern District of West Virginia has been scheduled for August 13, 2024.

Post-Grant Proceedings

8 unchanged sentences

European Patent No.

3,716,992 (the "EP '992 Patent") Amgen and three anonymous parties Opposition proceedings May 5-10, 2023 Oral hearing to be scheduled.

3,716,992 (the "'992 Patent")

Amgen and three anonymous parties Opposition proceedings May 5-10, 2023 Oral hearing to be scheduled.

EPO European Patent No.

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Formycon AG and Klinge Biopharma GmbH Invalidation proceedings and declaration of non-infringement by challengers' aflibercept 2 mg biosimilar

April 18, 2024 Trial to be scheduled.

April 18, 2024 Trial has been scheduled to begin in June 2025.

High Court of Justice of England and Wales United Kingdom designation of the '992 Patent

Amgen Invalidation proceedings May 13, 2024 Stayed pending final resolution of the EPO opposition proceedings listed above.

District Court of The Hague, the Netherlands Dutch designation of the '691 Patent and '306 Patent Samsung Bioepis NL B.V.

Invalidation proceedings July 17, 2024

Trial for both patents has been scheduled for July 18, 2025.

High Court of Justice of England and Wales

United Kingdom designation of the '992 Patent

Samsung Bioepis UK Limited

Invalidation proceedings

July 24, 2024

Trial to be scheduled.

Proceedings against Viatris Canada and BCIL

In 2022, the Company and Bayer Inc.

filed patent infringement lawsuits against BGP Pharma ULC d.b.a Viatris Canada ("Viatris Canada") in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's Canadian Patent Nos.

2,654,510 (the "'510 Patent") and 3,007,276 (the "'276 Patent") (in the lawsuit filed on June 15, 2022);

the Company's Canadian Patent No.

2,965,495 (the "'495 Patent") (in the lawsuit filed on July 15, 2022);

the Company's Canadian Patent No.

2,906,768 (the "'768 Patent") (in the lawsuit filed on August 30, 2022, which has been joined with the lawsuit filed on July 15, 2022);

and the Company's Canadian Patent No.

3,129,193 (the "'193 Patent") (in the lawsuit filed on October 4, 2022).

On June 5, 2023, following the transfer of Viatris Canada's New Drug Submission of its aflibercept 2 mg biosimilar to Biosimilar Collaborations Ireland Limited ("BCIL"), BCIL was added as a defendant in the lawsuit concerning the '510 Patent and the '276 Patent.

On March 23, 2023 and June 14, 2023, the Company and Bayer Inc.

filed patent infringement lawsuits against BCIL in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's '510 and '276 Patents.

On September 14, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Viatris Canada and BCIL in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of Bayer Healthcare LLC's Canadian Patent No.

2,970,315 (the "'315 Patent").

On March 1, 2024, the Company, Bayer Inc., Bayer Healthcare LLC, Viatris Canada, BCIL, and Biocon Biologics Limited entered into a settlement agreement concerning the lawsuits described in the preceding two paragraphs.

On March 1, 2024, the Company, Bayer Inc., Bayer Healthcare LLC, BGP Pharma ULC d.b.a.

Viatris Canada ("Viatris Canada"), Biosimilar Collaborations Ireland Limited ("BCIL"), and Biocon Biologics Limited entered into a settlement agreement concerning the previously disclosed patent infringement lawsuits.

Pursuant to the settlement agreement, each of such lawsuits has been dismissed and BCIL is generally precluded from launching its aflibercept 2 mg biosimilar product in Canada until July 1, 2025.

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On May 9, 2023, Amgen Canada Inc.

("Amgen Canada") filed invalidation proceedings against the Company in the Federal Court of Canada seeking revocation of the '510 Patent and the '276 Patent.

On September 14, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the '315 Patent.

("Amgen Canada") filed invalidation proceedings against the Company in the Federal Court of Canada seeking revocation of the Company's Canadian Patent Nos.

2,654,510 (the "'510 Patent") and 3,007,276 (the "'276 Patent").

2,970,315 (the "'315 Patent").

On September 14, 2023, the Company and Bayer Inc.

filed three separate patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's '193 Patent, '495 Patent, and '768 Patent, respectively.

3,129,193 (the "'193 Patent"), 2,965,495 (the "'495 Patent"), and 2,906,768 (the "'768 Patent"), respectively.

On October 11, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed two separate patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's '510 Patent and '276 Patent, respectively.

A trial for the lawsuits concerning the '510 Patent and the '276 Patent has been scheduled for May 2025.

On May 7, 2024 and June 28, 2024, respectively, Amgen filed a summary trial motion with respect to the '510 Patent and a motion to delist the '276 Patent from the Canada Patent Register.

Hearings for both motions have been scheduled for November 2024.

A trial for the lawsuits concerning the '510 Patent and the '276 Patent has been scheduled for May-June 2025;

and a trial for the lawsuits concerning the '315 Patent and the '193 Patent has been scheduled for August-September 2025.

Proceedings against Celltrion

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in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the '510 Patent, the '276 Patent, the '495 Patent, the '768 Patent, the '193 Patent, and the '315 Patent.

On July 2, 2024, the Company, Bayer Inc., Bayer Healthcare LLC, and Celltrion, Inc.

entered into a settlement agreement concerning these patent infringement lawsuits, pursuant to which each such lawsuit has been dismissed and Celltrion is generally precluded from launching its aflibercept 2 mg biosimilar product in Canada until July 1, 2025.

Proceedings against Apotex

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An oral hearing for certain motions concerning the '276 Patent, the '315 Patent, and the '510 Patent has been scheduled for July 8-9, 2024.

On June 21, 2024, the Company, Bayer Inc., Bayer Healthcare LLC, and Apotex Inc.

entered into a settlement agreement concerning these patent infringement lawsuits, pursuant to which each such lawsuit has been dismissed and Apotex is generally precluded from launching its aflibercept 2 mg biosimilar product in Canada until July 1, 2025.

On October 31, 2022 and December 13, 2022, Samsung Bioepis Co., Ltd.

initiated invalidation proceedings before the Intellectual Property Trial and Appeal Board of the Korean Intellectual Property Office against the Company's Korean Patent Nos.

1131429 and 1406811, respectively, seeking revocation of each of such patents in its entirety.

On January 16, 2023, the Company filed patent infringement lawsuits against Samsung Bioepis Co., Ltd.

and its parent company Samsung Biologics Co., Ltd.

before the Seoul Central District Court seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would infringe one or more claims of the Company's Korean Patent No.

1131429 and 1406811 (the "'811 Patent"), respectively, seeking revocation of each of such patents in its entirety.

On January 8, 2024, the Company and Bayer Consumer Care AG filed a patent infringement lawsuit against Sam Chun Dang Pharm.

and OPTUS Pharmaceutical Co., Ltd before the Seoul Central District Court seeking damages based on an

allegation that offering to sell an aflibercept 2 mg biosimilar would infringe one or more claims of the Company's Korean Patent No.

659477 (the "'477 Patent").

On July 20, 2023, the Company filed a preliminary injunction petition against Samsung Bioepis Co., Ltd.

On January 10, 2024, the Company and Bayer Consumer Care AG filed a patent infringement lawsuit against Celltrion Inc.

before the Seoul Central District Court seeking damages and injunctive relief based on an allegation that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would infringe one or more claims of the '477 Patent, the '811 Patent, and Korean Patent No.

2519234 (the "'234 Patent").

On January 16, 2023, the Company filed a patent infringement lawsuit against Samsung Bioepis Co., Ltd.

and its parent company Samsung Biologics Co., Ltd.

before the Seoul Central District Court seeking a court order enjoining the manufacture, use, and assignment of an aflibercept 2 mg biosimilar that infringes one or more claims of the '477 Patent;

and on December 20, 2023, the Seoul Central District Court granted a preliminary injunction.

On January 10, 2024, the injunction was lifted against the Samsung entities following the expiration of the '477 Patent.

On March 2, 2023, the Company filed an affirmative scope confirmation action against Samsung Bioepis Co., Ltd.

before the Intellectual Property Tribunal and Appeal Board of the Korean Intellectual Property Office seeking a ruling that Samsung Bioepis's aflibercept 2 mg biosimilar is covered by the claims of the '477 Patent.

In March 2024, these proceedings were terminated as a result of the expiration of the '477 Patent.

before the Seoul Central District Court seeking damages based on an allegation that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would infringe one or more claims of the '477 Patent.

On May 8, 2024, the Company and Bayer Consumer Care AG filed a patent infringement lawsuit against Sam Chun Dang Pharm.

and OPTUS Pharmaceutical Co., Ltd before the Seoul Central District Court seeking damages and injunctive relief based on an allegation that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would infringe one or more claims of the '811 patent and the '234 Patent.

On May 14, 2024, the Company and Bayer Consumer Care AG filed a patent infringement lawsuit against Samsung Bioepis Co., Ltd., its parent company Samsung Biologics Co., Ltd., and Samil Pharmaceuticals Co., Ltd.

before the Seoul Central District Court seeking injunctive relief based on an allegation that the making, constructing, using, or selling of an aflibercept 2mg biosimilar would infringe one or more claims of the '811 Patent and the '234 Patent.

Proceedings Relating to EYLEA (aflibercept) Injection Pre-filled Syringe

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On December 23, 2022, Novartis filed a notice of appeal of the PTAB's decision to the Federal Circuit.

An oral hearing has been scheduled for August 6, 2024.

On July 17, 2020, the Company filed an antitrust lawsuit against Novartis and Vetter Pharma International Gmbh ("Vetter") in the United States District Court for the Southern District of New York seeking a declaration that the '631 Patent is unenforceable and a judgment that the defendants' conduct violates Sections 1 and 2 of the Sherman Antitrust Act of 1890, as amended (the "Sherman Antitrust Act").

The Company is also seeking injunctive relief and treble damages.

On September 4, 2020, Novartis filed, and Vetter moved to join, a motion to dismiss the complaint, to transfer the lawsuit to the Northern District of New York, or to stay the suit;

On September 4, 2020, Novartis filed, and Vetter moved to join, a motion to dismiss the complaint, to transfer the lawsuit to the Northern District of New York, or to stay the lawsuit;

and on October 19, 2020, Novartis filed, and Vetter moved to join, a second motion to dismiss the complaint on different grounds.

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10,221,221 (the "'221 Patent").

Allele seeks a judgment of patent infringement of the '221 Patent, an award of monetary damages (together with interest), an order of willful infringement of the '221 Patent (which would allow the court in its discretion to award damages up to three times the amount assessed), costs and expenses of the lawsuit, and attorneys' fees.

Allele seeks a judgment of patent infringement of the '221 Patent, an award of monetary damages (together with interest), an order of willful infringement of the '221 Patent (which

would allow the court in its discretion to award damages up to three times the amount assessed), costs and expenses of the lawsuit, and attorneys' fees.

On July 16, 2021, the Company filed a motion to dismiss the complaint, which motion was denied on March 2, 2022.

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Court of Appeals for the First Circuit certified for appeal (i.e., accepted for review) the court's September 27, 2023 order.

An oral hearing concerning the appeal to the U.S.

Court of Appeals for the First Circuit was held on July 22, 2024.

In September 2019, the Company and Regeneron Healthcare Solutions, Inc., a wholly-owned subsidiary of the Company, each received a civil investigative demand ("CID") from the U.S.

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The CIDs relate to EYLEA, Praluent, Dupixent, ZALTRAP, ARCALYST, and Kevzara and cover the period from January 2015 to the present.

June 3, 2021, the United States District Court for the Central District of California unsealed a qui tam complaint filed against the Company, Regeneron Healthcare Solutions, Inc., and Sanofi-Aventis U.S.

On June 3, 2021, the United States District Court for the Central District of California unsealed a qui tam complaint filed against the Company, Regeneron Healthcare Solutions, Inc., and Sanofi-Aventis U.S.

LLC by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states (the "State Plaintiffs"), asserting causes of action under the federal False Claims Act and state law.

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On March 28, 2024, the Department of Justice and the U.S.

Attorney's Office for the District of Massachusetts filed a civil complaint intervention in the U.S.

Attorney's Office for the District of Massachusetts filed a civil complaint intervention (the "March 2024 Civil Complaint") in the U.S.

District Court for the District of Massachusetts asserting causes of action under the federal False Claims Act and a claim for unjust enrichment.

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District Court of the District of Massachusetts unsealed a qui tam complaint against the Company, AmerisourceBergen, and Besse Medical by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states and municipalities, asserting causes of action under the federal False Claims Act and state and local laws, and alleging violations of the federal Anti-Kickback statute.

On June 25, 2024, the States of Colorado, Georgia, Michigan, North Carolina, Texas, and Washington filed a civil complaint in partial intervention (the "June 2024 Civil Complaint") in the U.S.

District Court for the District of Massachusetts asserting causes of action under various states laws.

On July 18, 2024, the Company filed a motion to dismiss the March 2024 Civil Complaint and the June 2024 Civil Complaint.

California Department of Insurance Subpoena

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The Company is cooperating with this investigation.

Proceedings Initiated by Other Payors Relating to Patient Assistance Organization Support

Proceedings Initiated by Other Payors

The Company is party to several lawsuits relating to the conduct alleged in the June 2020 Civil Complaint discussed under "Department of Justice Matters" above.

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District Court for the District of Massachusetts on December 20, 2021, February 23, 2022, April 4, 2022, and June 17, 2022, respectively.

These lawsuits allege causes of action under state law and the federal Racketeer Influenced and Corrupt Organizations Act and seek monetary damages and equitable relief.

These lawsuits allege causes of action under state law and the federal Racketeer Influenced and Corrupt Organizations Act ("RICO") and seek monetary damages and equitable relief.

The MMO and Local 464A lawsuits are putative class action lawsuits.

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and, in light of these stays, the parties to the Local 464A action have also agreed to stay that matter.

On June 24, 2024, a group of plaintiffs purporting to be assignees of claims by various Medicare Advantage plans and related entities filed a putative class action complaint in the U.S.

District Court for the District of Columbia on behalf of Medicare Advantage plans and other payors.

The lawsuit relates to the conduct alleged in the June 2020 Civil Complaint, March 2024 Civil Complaint, and June 2024 Civil Complaint discussed under "Department of Justice Matters" above.

The lawsuit alleges causes of action under state law and RICO and seeks monetary damages and equitable relief.

Proceedings Relating to Shareholder Derivative Complaint

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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.

What changed 10-Q

Item 1. Financial Statements