What changed in this filing

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Item 1. Financial Statements

2023-08-03 compared with 2023-05-04 · 156 added, 61 removed, 562 unchanged (28% 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

June 30, Six Months Ended

2023 2022 2023 2022

Statements of Operations

12 unchanged sentences

Other income (expense):

Other (expense) income, net ( 70.7 ) ( 183.8 )

Other income (expense), net 85.3 ( 133.6 ) 14.6 ( 317.4 )

Interest expense ( 18.9 ) ( 13.1 ) ( 36.9 ) ( 26.7 )

10 unchanged sentences

Other comprehensive income (loss), net of tax:

Unrealized gain (loss) on debt securities 57.2 ( 144.9 )

Unrealized (loss) gain on debt securities ( 15.7 ) ( 53.7 ) 41.5 ( 198.6 )

Loss on foreign currency translation ( 0.4 ) — ( 0.4 ) —

Unrealized gain on cash flow hedges — — — 1.0

4 unchanged sentences

(In millions)

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

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

12 unchanged sentences

Balance, March 31, 2023 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

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, 2021 1.8 $ — 126.2 $ 0.1 $ 8,087.5 $ 18,968.3 $ ( 26.2 ) ( 19.4 ) $ ( 8,260.9 ) $ 18,768.8

7 unchanged sentences

Balance, March 31, 2022 1.8 — 127.6 0.1 8,754.1 19,941.8 ( 170.1 ) ( 19.9 ) ( 8,611.2 ) 19,914.7

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

— — 0.8 — 228.0 — — — — 228.0

Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations

— — ( 0.1 ) — ( 41.9 ) — — — — ( 41.9 )

Issuance/distribution of Common Stock for 401(k) Savings Plan

— — — — 14.0 — — — 2.2 16.2

Repurchases of Common Stock

— — — — — — — ( 0.7 ) ( 393.6 ) ( 393.6 )

Stock-based compensation charges — — — — 166.0 — — — — 166.0

Net income — — — — — 852.1 — — — 852.1

Other comprehensive loss, net of tax — — — — — — ( 53.7 ) — — ( 53.7 )

Balance, June 30, 2022 1.8 $ — 128.3 $ 0.1 $ 9,120.2 $ 20,793.9 $ ( 223.8 ) ( 20.6 ) $ ( 9,002.6 ) $ 20,687.8

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:

6 unchanged sentences

Deferred income taxes ( 425.8 ) ( 381.0 )

Acquired in-process research and development in connection with asset acquisition — 195.0

Changes in assets and liabilities:

11 unchanged sentences

Payments for Libtayo intangible asset ( 121.8 ) —

Asset acquisition, net of cash acquired — ( 230.3 )

Net cash used in investing activities ( 2,622.6 ) ( 2,119.2 )

3 unchanged sentences

Repurchases of Common Stock ( 1,399.5 ) ( 717.1 )

Net cash (used in) provided by financing activities ( 322.5 ) 64.7

Net increase in cash, cash equivalents, and restricted cash 809.4 461.1

Net cash used in financing activities ( 936.7 ) ( 36.4 )

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

Net (decrease) increase in cash, cash equivalents, and restricted cash ( 1,169.7 ) 510.5

Cash, cash equivalents, and restricted cash at beginning of period 3,119.4 2,898.1

16 unchanged sentences

Three Months Ended

June 30, Six Months Ended

(In millions) 2023 2022 2023 2022

1 unchanged sentence

130.2 90.9 239.9 169.8

79.8 — 147.0 —

40.5 31.2 80.7 64.8

19.3 11.1 34.2 19.6

$ 1,772.1 $ 1,754.4 $ 3,440.1 $ 3,393.0

(a) Prior to July 1, 2022, Regeneron recorded net product sales of Libtayo in the United States and Sanofi recorded net product sales of Libtayo outside the United States.

2 unchanged sentences

(b) Rest of world ("ROW")

As of March 31, 2023 and December 31, 2022, the Company had $ 3.578 billion and $ 3.586 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, 2023 and 2022.

As of June 30, 2023 and December 31, 2022, the Company had $ 3.718 billion and $ 3.586 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 and six months ended June 30, 2023 and 2022.

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

Three Months Ended

June 30, Six Months Ended

2023 2022 2023 2022

Besse Medical, a subsidiary of AmerisourceBergen Corporation

51 % 57 % 51 % 56 %

McKesson Corporation 25 % 28 % 25 % 29 %

2 unchanged sentences

Statement of Operations Classification Three Months Ended

June 30, Six Months Ended

(In millions) 2023 2022 2023 2022

2 unchanged sentences

Reimbursement for manufacturing of commercial supplies Collaboration revenue $ 192.6 $ 145.5 $ 354.5 $ 306.3

Other Collaboration revenue $ — $ 28.9 $ — $ 28.9

Regeneron's obligation for its share of Sanofi R&D expenses, net of reimbursement of R&D expenses (R&D expense)/Reduction of R&D expense $ ( 14.5 ) $ 37.1 $ ( 40.9 ) $ 63.9

23 unchanged sentences

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

March 31, December 31,

June 30, December 31,

(In millions) 2023 2022

15 unchanged sentences

Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally.

Bayer markets EYLEA outside the United States, and the companies share equally in profits and losses from such sales.

Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits and losses from such sales.

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

Statement of Operations Classification Three Months Ended

June 30, Six Months Ended

(In millions) 2023 2022 2023 2022

6 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) 2023 2022

2 unchanged sentences

$ 124.8 $ 131.9

The Company is a party to a collaboration agreement (the "Roche 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).

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 of 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.

Amounts recognized in the Company's Statements of Operations in connection with the Roche Collaboration Agreement are as follows:

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

Statement of Operations Classification Three Months Ended

June 30, Six Months Ended

(In millions) 2023 2022 2023 2022

Global gross profit payment from Roche in connection with sales of Ronapreve Collaboration revenue $ — $ 8.2 $ 222.2 $ 224.5

Reimbursement of research and development expenses from Roche was not material for the three months ended March 31, 2023 and 2022.

The following table summarizes contract balances in connection with the Roche Collaboration Agreement:

March 31, December 31,

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

Reimbursement of research and development expenses from Roche was not material for the three and six months ended June 30, 2023 and 2022.

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

June 30, December 31,

(In millions) 2023 2022

Accounts receivable, net $ — $ 396.6

In 2019, the Company and Alnylam entered into a global, strategic collaboration to discover, develop, and commercialize RNA interference ("RNAi") therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system ("CNS"), in addition to a select number of targets expressed in the liver.

In connection with entering into the collaboration, the Company made an up-front payment of $ 400.0 million to Alnylam, and also purchased shares of Alnylam common stock for $ 400.0 million.

For each program, the Company provides Alnylam with a specified amount of funding at program initiation and at lead candidate designation, and Alnylam is eligible to receive two $ 100.0 million clinical proof-of-principle milestones for each of the eye and CNS programs (an aggregate of $ 200.0 million in development milestones).

Under the terms of the collaboration, the parties plan to 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 ("Co-Co Collaboration Agreement") (under which the parties are advancing ALN-APP and ALN-PNP, which are currently in clinical development) or license agreement.

Amounts recognized in the Company's Statements of Operations in connection with its Alnylam collaboration were not material for the three and six months ended June 30, 2023 and 2022.

In addition, contract balances in the Company's Balance Sheets were not material as of June 30, 2023 and December 31, 2022.

Sonoma Biotherapeutics, Inc.

5 unchanged sentences

The Company will have the option to lead late-stage development and commercialization on all products globally, with Sonoma retaining rights to co-promote all such products in the United States.

In May 2022, the Company completed its acquisition of Checkmate Pharmaceuticals, Inc.

(“Checkmate”) for a total equity value of approximately $ 250 million.

As a result of the transaction, which was accounted for as an asset acquisition, the Company recorded (i) a charge of $ 195.0 million to Acquired in-process research and development and (ii) net assets of $ 35.3 million, net of cash, related to the assets acquired (including deferred tax assets and investments) and liabilities assumed.

Net Income Per Share

4 unchanged sentences

Three Months Ended

June 30, Six Months Ended

(In millions, except per share data) 2023 2022 2023 2022

9 unchanged sentences

Three Months Ended

June 30, Six Months Ended

(Shares in millions) 2023 2022 2023 2022

1 unchanged sentence

Marketable Securities

Marketable securities as of March 31, 2023 and December 31, 2022 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, 2023 and December 31, 2022 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, 2023

As of June 30, 2023

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, 2023 mature at various dates through August 2028.

The available-for-sale debt securities as of June 30, 2023 mature at various dates through April 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) 2023 2022

6 unchanged sentences

(In millions)

As of March 31, 2023

As of June 30, 2023

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

13 unchanged sentences

$ 3,300.9 $ ( 76.9 ) $ 4,332.2 $ ( 225.9 ) $ 7,633.1 $ ( 302.8 )

The unrealized losses on corporate bonds as of March 31, 2023 were primarily driven by increases in interest rates.

The unrealized losses on corporate bonds as of June 30, 2023 were primarily driven by increases in 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, 2023 and 2022, amounts reclassified from Accumulated other comprehensive loss into Other (expense) income, net were related to realized gains and losses on sales of available-for-sale debt securities.

For the three months ended March 31, 2023 and 2022, realized gains and losses on sales of marketable securities were not material.

With respect to marketable securities, for the three and six months ended June 30, 2023 and 2022, 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 months ended ended June 30, 2023, realized gains on sales of marketable securities were not material and there were no realized losses.

For the six months ended June 30, 2023, and for the three and six months ended June 30, 2022, realized gains and 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, 2023

As of June 30, 2023

Fair Value Level 1 Level 2

22 unchanged sentences

$ 12,891.0 $ 1,298.3 $ 11,592.7

The Company held certain restricted equity securities as of March 31, 2023 which are subject to transfer restrictions that expire at various dates through 2024.

During the three months ended March 31, 2023 and 2022, we recorded $ 164.7 million and $ 211.2 million of net unrealized losses, respectively, on equity securities in Other (expense) income, net.

In addition to the investments summarized in the table above, as of both March 31, 2023 and December 31, 2022, the Company had $ 48.3 million in equity investments that do not have a readily determinable fair value.

The Company held certain restricted equity securities as of June 30, 2023 which are subject to transfer restrictions that expire at various dates through 2024.

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

and during the three and six months ended June 30, 2022, we recorded $ 163.7 million and $ 374.9 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, 2023 and December 31, 2022, the Company had $ 78.3 million and $ 48.3 million, respectively, in equity investments that do not have a readily determinable fair value.

These investments are recorded within Other noncurrent assets.

The fair value of our long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.516 billion and $ 1.443 billion as of March 31, 2023 and December 31, 2022, respectively.

The fair value of our long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.476 billion and $ 1.443 billion as of June 30, 2023 and December 31, 2022, respectively.

Inventories consist of the following:

March 31, December 31,

June 30, December 31,

(In millions) 2023 2022

4 unchanged sentences

$ 2,507.7 $ 2,401.9

Inventory balances in the table above are net of reserves of $ 752.3 million and $ 720.7 million as of March 31, 2023 and December 31, 2022, respectively.

Inventory balances in the table above are net of reserves of $ 747.9 million and $ 720.7 million as of June 30, 2023 and December 31, 2022, respectively.

Deferred costs represent the costs of product manufactured and shipped to the Company's collaborators for which recognition of revenue has been deferred.

1 unchanged sentence

federal, state, and foreign income taxes.

The Company's effective tax rate was 4.7 % and 8.3 % for the three months ended March 31, 2023 and 2022, respectively.

The Company's effective tax rate for the three months ended March 31, 2023 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 Company's effective tax rate was 10.6 % and 11.5 % for the three months ended June 30, 2023 and 2022, respectively, and 8.0 % and 9.8 % for the six months ended June 30, 2023 and 2022, respectively.

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.

The Company's effective tax rate for the three and six months ended June 30, 2022 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.

In August 2022, the Inflation Reduction Act of 2022 ("IRA") was signed into law in the United States.

1 unchanged sentence

The provisions of the IRA became effective for periods beginning after December 31, 2022.

The IRA had no impact on the Company's financial statements for the three months ended March 31, 2023.

The Company's effective tax rate for the three months ended March 31, 2022 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 stock-based compensation.

The IRA did not have a material impact on the Company's financial statements for the three and six months ended June 30, 2023.

Stockholders' Equity

1 unchanged sentence

In November 2021, our board of directors authorized a share repurchase program to repurchase up to $ 3.0 billion of our 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, our board of directors authorized an additional share repurchase program to repurchase up to $ 3.0 billion of our 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.

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

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

As of March 31, 2023, an aggregate of $ 3.051 billion remained available for share repurchases under the Company's share repurchase programs.

As of June 30, 2023, $ 2.332 billion remained available for share repurchases under the January 2023 program.

The table below summarizes the shares of our Common Stock we repurchased and the cost of the shares, which were recorded as Treasury Stock.

As described in Note 8, effective January 1, 2023 share repurchases, net of issuances, are subject to a 1% excise tax;

such amount, if applicable, is recognized as an additional cost of the shares acquired.

Three Months Ended

June 30, Six Months Ended

(In millions) 2023 2022 2023 2022

5 unchanged sentences

Cash and cash equivalents $ 1,937.2 $ 3,395.1

Restricted cash included in Prepaid expenses and other current assets 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) 2023 2022 2022 2021

7 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, 2023 and December 31, 2022, the Company's accruals for loss contingencies were not material.

As of June 30, 2023 and December 31, 2022, 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.

2 unchanged sentences

(and/or its affiliated entities) against the Company and/or Sanofi (and/or the Company's and Sanofi's respective affiliated entities) in a number of jurisdictions relating to Praluent.

In addition, as described below, the Company filed a lawsuit against Amgen alleging that Amgen engaged in an anticompetitive bundling scheme which was designed to exclude Praluent from the market in violation of federal and state laws.

federal and state laws.

United States

In the United States, Amgen has asserted claims of U.S.

In the United States, Amgen asserted claims of U.S.

8,829,165 (the "'165 Patent") and 8,859,741 (the "'741 Patent"), and sought a permanent injunction to prevent the Company and the Sanofi defendants from commercial manufacturing, using, offering to sell, or selling within the United States (as well as importing into the United States) (collectively, "Commercializing") Praluent.

Amgen also seeks a judgment of patent infringement of the asserted patents, monetary damages (together with interest), costs and expenses of the lawsuits, and attorneys' fees.

Amgen also sought a judgment of patent infringement of the asserted patents,

monetary damages (together with interest), costs and expenses of the lawsuits, and attorneys' fees.

As previously reported, on February 11, 2021, the United States Court of Appeals for the Federal Circuit (the "Federal Circuit") affirmed the lower court's decision that certain of Amgen's asserted patent claims are invalid based on lack of enablement.

2 unchanged sentences

An oral hearing was held on March 27, 2023.

On May 28, 2023, the United States Supreme Court affirmed the Federal Circuit's decision that certain of Amgen's asserted patent claims are invalid based on lack of enablement.

On May 27, 2022, the Company filed a lawsuit against Amgen in the United States District Court for the District of Delaware, alleging that, beginning in 2020, Amgen engaged in an anticompetitive bundling scheme which was designed to exclude Praluent from the market in violation of federal and state laws.

18 unchanged sentences

Amgen filed a notice to appeal to the TBA of the EPO on February 27, 2023.

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.

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 the '124 Patent discussed above.

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

Proceedings Relating to EYLEA (aflibercept) Injection

12 unchanged sentences

An oral hearing was held on August 10, 2022.

On November 9, 2022, the USPTO issued final written decisions finding that the claims of the '338 and '069 Patents are unpatentable and, therefore, invalid.

On November 9, 2022, the USPTO issued final written decisions finding that the claims of the '338 and '069 Patents are unpatentable and,

therefore, invalid.

On January 10, 2023, the Company filed notices of appeal of the USPTO written decisions concerning the '338 and '069 Patents with the Federal Circuit.

6 unchanged sentences

filed separate IPR petitions against the Company's '681 Patent and '601 Patent, respectively, seeking declarations of invalidity of such patents.

On July 19, 2023, the USPTO instituted an IPR proceeding concerning the '681 Patent.

On September 9, 2022, Apotex filed an IPR petition against the Company's U.S.

4 unchanged sentences

On January 17, 2023 and February 28, 2023, Celltrion filed IPR petitions against the '992 Patent and the '226 Patent, respectively, seeking declarations of invalidity of such patents.

On July 20, 2023, the USPTO instituted an IPR proceeding concerning the '992 Patent.

On August 2, 2022, the Company filed a patent infringement lawsuit against Mylan in the United States District Court for the Northern District of West Virginia alleging that Mylan's filing for a U.S.

2 unchanged sentences

On April 26, 2023, the Company filed a stipulation accepting summary judgment of noninfringement of all asserted claims of the Company's U.S.

A trial has been scheduled to begin on June 12, 2023 concerning certain claims of the '601 Patent, the '572 Patent, and the Company's U.S.

A trial was held from June 12, 2023 through June 23, 2023 concerning certain claims of the '601 Patent, the '572 Patent, and the Company's U.S.

Closing arguments have been scheduled for August 3, 2023.

On October 26 and October 27, 2021, anonymous parties initiated opposition proceedings in the EPO against the Company's European Patent No.

2,944,306 (the "'306 Patent") seeking revocation of the '306 Patent in its entirety.

Between May 5-10, 2023, Amgen and three anonymous parties initiated opposition proceedings in the EPO against the Company's European Patent No.

3,716,992 (the "EP '992 Patent") seeking revocation of the EP '992 Patent in its entirety.

On June 22, 2023, Samsung Bioepis NL B.V.

initiated invalidation proceedings in the German Federal Patent Court against the German designation of the Company's European Patent No.

2,364,691 (the "'691 Patent") seeking revocation of the '691 Patent in its entirety.

On June 15, July 15, August 30, and October 4, 2022, the Company and Bayer Inc.

7 unchanged sentences

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

A trial for the lawsuit concerning the '510 Patent and the '276 Patent has been scheduled for March 2024;

A trial for the lawsuit concerning the '510 Patent and the '276 Patent (the "Viatris Canada 510/276 Lawsuit") has been scheduled for March 2024;

a trial for the lawsuit concerning the '193 Patent has been scheduled for May 2024;

and a trial for the lawsuit concerning the '495 Patent and the '768 Patent has been scheduled for November/December 2024.

The filing of the lawsuit concerning the '510 Patent and the '276 Patent resulted in a statutory 24-month stay of regulatory approval of Viatris Canada's aflibercept biosimilar in Canada unless the lawsuit is resolved earlier.

On March 27, 2023, in light of the transfer of the New Drug Submission ("NDS") discussed below, the Company filed a motion in the Federal Court of Canada seeking termination of the Viatris Canada action relating to the '510 Patent and the '276 Patent in the Federal Court of Canada.

On March 23, 2023, following the transfer of Viatris Canada's NDS of its aflibercept biosimilar to Biosimilar Collaborations Ireland Limited ("BCIL"), the Company and Bayer Inc.

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

The filing of the Viatris Canada 510/276 Lawsuit resulted in a statutory 24-month stay of regulatory approval of Viatris Canada's aflibercept biosimilar in Canada unless the lawsuit is resolved earlier.

On March 27, 2023, in light of the transfer of Viatris Canada's New Drug Submission ("NDS") of its aflibercept biosimilar to Biosimilar Collaborations Ireland Limited ("BCIL"), the Company filed a motion in the Federal Court of Canada seeking termination of the Viatris Canada 510/276 Lawsuit.

On June 5, 2023, BCIL was added as a defendant in the Viatris Canada 510/276 Lawsuit.

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 biosimilar would

directly or indirectly infringe one or more claims of the Company's '510 and '276 Patents.

The June 14, 2023 lawsuit was filed after BCIL served Bayer Inc.

with a statutory notification in relation to the NDS on May 23, 2023.

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

2 unchanged sentences

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

and its parent Samsung Biologics Co., Ltd.

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

and its parent company Samsung Biologics Co., Ltd.

659477 (the "'477 Patent").

On July 20, 2023, the Company filed a preliminary injunction petition 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 biosimilar that infringes one or more claims of the '477 Patent.

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

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9,220,631 (the "'631 Patent") and seeking preliminary and permanent injunctions to prevent the Company from continuing to infringe the '631 Patent.

Novartis also seeks a judgment of patent infringement of the '631 Patent, monetary damages (together with interest), an order of willful infringement of the '631 Patent (which would allow the court in its discretion to award damages up to three times the amount assessed), costs and

expenses of the lawsuits, and attorneys' fees.

On November 7, 2022, the Company and Novartis entered into a stipulation staying the lawsuit in light of the decision in the IPR proceeding discussed below.

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On October 5, 2020, Allele Biotechnology and Pharmaceuticals, Inc.

("Allele") filed a lawsuit (as amended on April 8, 2021 and December 12, 2022) against the Company in the United States District Court for the Southern District of New York, asserting infringement of U.S.

("Allele") filed a lawsuit (as amended on April 8, 2021 and December 12, 2022) against the Company in the United States District Court for the Southern District of New York,

asserting infringement of U.S.

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

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On January 31, 2023, the Company filed a motion for summary judgment.

An oral hearing on the parties' respective motions for summary judgment was held on July 21, 2023.

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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On January 14, 2022, the Company filed a motion to dismiss the amended complaint in its entirety.

On July 25, 2023, the court in part granted and in part denied the Company's motion to dismiss.

In June 2021, the Company received a CID from the U.S.

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

On December 29, 2021, the lawsuits filed by UHC and Humana were stayed by the United States District Court for the Southern District of New York pending resolution of the proceedings before the U.S.

On December 29, 2021, the lawsuits filed by UHC and Humana were stayed

by the United States District Court for the Southern District of New York pending resolution of the proceedings before the U.S.

District Court for the District of Massachusetts discussed under "Department of Justice Matters" above.

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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