What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2024-10-31 compared with 2024-08-01 · 193 added, 111 removed, 635 unchanged (32% of the section changed)

3 unchanged sentences

(In millions, except per share data)

June 30, December 31,

September 30, December 31,

Current assets:

34 unchanged sentences

Retained earnings 30,755.2 27,260.3

Accumulated other comprehensive loss ( 69.9 ) ( 80.9 )

Accumulated other comprehensive income (loss)

60.2 ( 80.9 )

Treasury Stock, at cost;

8 unchanged sentences

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

Statements of Operations

28 unchanged sentences

Other comprehensive income (loss), net of tax:

Unrealized gain (loss) on debt securities

Unrealized gain on debt securities

128.2 21.3 139.6 62.8

Loss on foreign currency translation

Gain (loss) on foreign currency translation

1.9 ( 0.4 ) 1.5 ( 0.8 )

29 unchanged sentences

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

Issuance of Common Stock for equity awards granted under long-term incentive plans — — 0.6 — 255.7 — — — — 255.7

Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.1 ) — ( 120.2 ) — — — — ( 120.2 )

Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 20.0 — — — 1.8 21.8

Repurchases of Common Stock — — — — — — — ( 0.6 ) ( 738.3 ) ( 738.3 )

Stock-based compensation charges — — — — 230.4 — — — — 230.4

Net income — — — — — 1,340.6 — — — 1,340.6

Other comprehensive income, net of tax

— — — — — — 130.1 — — 130.1

Balance, September 30, 2024

1.8 $ — 135.3 $ 0.1 $ 12,702.8 $ 30,755.2 $ 60.2 ( 27.0 ) $ ( 14,192.4 ) $ 29,325.9

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

23 unchanged sentences

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

Issuance of Common Stock for equity awards granted under long-term incentive plans — — 0.7 — 268.9 — — — — 268.9

Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.2 ) — ( 129.4 ) — — — — ( 129.4 )

Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 16.1 — — — 1.9 18.0

Repurchases of Common Stock — — — — — — — ( 0.6 ) ( 507.1 ) ( 507.1 )

Stock-based compensation charges — — — — 207.4 — — — — 207.4

Net income — — — — — 1,007.8 — — — 1,007.8

Other comprehensive income, net of tax

— — — — — — 20.9 — — 20.9

Balance, September 30, 2023

1.8 $ — 132.1 $ 0.1 $ 11,251.5 $ 26,100.7 $ ( 176.8 ) ( 25.1 ) $ ( 12,271.1 ) $ 24,904.4

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

2 unchanged sentences

(In millions)

Six Months Ended

Nine Months Ended

September 30,

Cash flows from operating activities:

4 unchanged sentences

(Gains) losses on marketable and other securities, net ( 331.2 ) 324.5

( 196.5 ) 197.5

Other non-cash items, net ( 31.9 ) 17.4

1 unchanged sentence

Changes in assets and liabilities:

(Increase) decrease in accounts receivable

Increase in accounts receivable

( 436.2 ) ( 256.1 )

12 unchanged sentences

Acquisitions, net of cash acquired

( 5.0 ) ( 51.1 )

Net cash used in investing activities ( 2,818.7 ) ( 3,118.9 )

4 unchanged sentences

Net cash used in financing activities ( 1,065.0 ) ( 1,344.0 )

( 431.0 ) ( 936.7 )

Effect of exchange rate changes on cash, cash equivalents, and restricted cash — ( 0.6 )

Net decrease in cash, cash equivalents, and restricted cash ( 726.0 ) ( 959.2 )

( 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

September 30, Nine Months Ended

September 30,

(In millions) 2024 2023 2024 2023

12 unchanged sentences

$ 1,946.4 $ 1,786.1 $ 5,626.3 $ 5,226.2

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.

As of September 30, 2024 and December 31, 2023, the Company had $ 4.142 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 nine months ended September 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

September 30,

Nine Months Ended

September 30,

2024 2023 2024 2023

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

As of September 30, 2024, the Company's contingent reimbursement obligation to Sanofi under the collaboration was approximately $ 1.810 billion.

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

During the three months ended September 30, 2023, the Company earned the final $ 50.0 million sales-based milestone from Sanofi upon aggregate annual sales of antibodies outside the United States exceeding $ 3.0 billion on a rolling twelve-month basis.

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

Statement of Operations Classification Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2024 2023 2024 2023

1 unchanged sentence

Collaboration revenue $ 1,088.3 $ 863.0 $ 2,880.6 $ 2,250.6

Sales-based milestones earned

Collaboration revenue

$ — $ 50.0 $ — $ 50.0

Reimbursement for manufacturing of commercial supplies Collaboration revenue $ 175.1 $ 151.5 $ 438.2 $ 506.0

3 unchanged sentences

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

June 30, December 31,

September 30, December 31,

(In millions) 2024

4 unchanged sentences

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

Within the United States, the Company is responsible for commercialization and retains profits from such sales.

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

Within the United States, the Company is responsible for commercialization and retains profits 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

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2024 2023 2024 2023

6 unchanged sentences

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

June 30, December 31,

September 30, December 31,

(In millions) 2024

4 unchanged sentences

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.

The parties share gross profits from worldwide sales.

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

Six Months Ended

September 30,

Nine Months Ended

September 30,

(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

Global gross profits earned in connection with sales of Ronapreve

Collaboration revenue $ 0.5 $ — $ 1.4 $ 222.2

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.

Collaboration revenue $ — $ ( 5.7 ) $ — $ ( 9.5 )

Contract balances in the Company's Balance Sheets in connection with the Roche collaboration were not material as of September 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.

1 unchanged sentence

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.

During the three and nine months ended September 30, 2024, the Company recorded to Acquired in-process research and development expense a $ 45.0 million development milestone in connection with the Company's collaboration agreement with Sonoma Biotherapeutics, Inc.

During the three and nine months ended September 30, 2023, the Company recorded to Acquired in-process research and development expense a $ 100.0 million development milestone in connection with the Company's collaboration agreement with Alnylam Pharmaceuticals, Inc.

Acquired in-process research and development expense for the nine months ended September 30, 2023 also included a $ 45.0 million u p-front payment in connection with the Company's collaboration agreement with Sonoma.

Net Income Per Share

4 unchanged sentences

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

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

9 unchanged sentences

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(Shares in millions) 2024 2023 2024 2023

1 unchanged sentence

Marketable Securities

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).

Marketable securities as of September 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 June 30, 2024

As of September 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 June 30, 2024 mature at various dates through June 2029.

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

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

June 30, December 31,

September 30, December 31,

(In millions) 2024

3 unchanged sentences

$ 14,967.4 $ 12,533.9

The following table shows the fair value of the Company's available-for-sale debt securities that have unrealized losses, aggregated by investment category and length of time that the individual securities have been in a continuous loss position.

The following table shows the fair value and gross unrealized losses by category and disaggregated by the length of time that the Company's available-for-sale debt securities have been in a continuous unrealized loss position.

Less than 12 Months 12 Months or Greater Total

(In millions)

As of June 30, 2024

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

As of September 30, 2024

Fair Value Unrealized Losses

Corporate bonds $ 6,351.7 $ ( 0.7 ) $ 1,415.6 $ ( 23.7 ) $ 7,767.3 $ ( 24.4 )

1 unchanged sentence

Sovereign bonds 46.0 — 20.9 ( 0.2 ) 66.9 ( 0.2 )

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

Certificates of deposit

384.3 ( 0.1 ) — — 384.3 ( 0.1 )

Asset-backed securities 141.6 — 32.3 ( 0.1 ) 173.9 ( 0.1 )

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 June 30, 2024 were primarily driven by increased interest rates.

The unrealized losses on corporate bonds were primarily driven by changes 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 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.

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

For the three and nine months ended September 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 June 30, 2024

As of September 30, 2024

Fair Value Level 1 Level 2 Level 3

8 unchanged sentences

Equity securities (unrestricted) 1,232.1 1,232.1 — —

Equity securities (restricted) 82.9 82.9 — —

Equity securities (restricted) (a)

76.1 76.1 — —

$ 17,210.4 $ 1,825.5 $ 15,384.9 $ —

Contingent consideration

14 unchanged sentences

$ 43.7 $ — $ — $ 43.7

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.

(a) Includes equity securities which are subject to transfer restrictions that expire in April 2026

In addition to the investments summarized in the table above, as of September 30, 2024 and December 31, 2023, the Company had $ 159.8 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.

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.

Also recorded within Other noncurrent assets as of September 30, 2024 were equity investments of $ 47.0 million which are measured at fair value based on Level 3 inputs;

no such investments were held by the Company as of December 31, 2023.

During the three and nine months ended September 30, 2024, the Company recorded $ 134.5 million and $ 330.8 million of net unrealized gains, respectively, on equity securities in Other income (expense), net;

and during the three and nine months ended September 30, 2023, the Company recorded $ 100.3 million and $ 295.9 million of net unrealized losses, respectively, on equity securities in Other income (expense), net.

In addition, during the three months ended September 30, 2023, the Company recorded a write-down of $ 29.0 million in Other income (expense), net related to the Company's investments in private companies.

The fair value of the Company's long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.577 billion and $ 1.528 billion as of September 30, 2024 and December 31, 2023, respectively.

Inventories consist of the following:

September 30,

(In millions) 2024

7 unchanged sentences

federal, state, and foreign income taxes.

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, 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.

The Company's effective tax rate was 10.2 % and 9.3 % for the three months ended September 30, 2024 and 2023, respectively, and 8.6 % and 8.4 % for the nine months ended September 30, 2024 and 2023, respectively.

The Company's effective tax rate for the three and nine months ended September 30, 2024 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 Company's effective tax rate for the nine months ended September 30, 2024 was negatively impacted by the remeasurement of existing uncertain tax positions.

The Company's effective tax rate for the three and nine months ended September 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.

1 unchanged sentence

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.

Repurchases may be made from time to time at management's discretion, and the timing and amount of any such repurchases will be determined based on share price, market conditions, legal requirements, and other relevant factors.

The program has no time limit and can be discontinued at any time.

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

As of September 30, 2024, the Company had repurchased the entire $ 3.0 billion of its Common Stock it was authorized to repurchase 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.

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 Securities Exchange Act of 1934, as amended (the "Exchange Act")), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act.

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

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2024 2023

1 unchanged sentence

Total cost of shares $ 738.3 $ 507.1 $ 1,637.7 $ 1,923.8

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

As of September 30, 2024, $ 2.893 billion remained available for share repurchases under the April 2024 program.

Statement of Cash Flows

The following provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Balance Sheets to the total of the same such amounts shown in the Condensed Consolidated Statements of Cash Flows:

September 30,

(In millions) 2024

Cash and cash equivalents $ 2,011.8 $ 2,152.3

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

Restricted cash included in Other noncurrent assets

1 unchanged sentence

$ 2,011.8 $ 2,160.2

Restricted cash consists of amounts held by financial institutions pursuant to contractual arrangements.

Restricted cash consisted of amounts held by financial institutions pursuant to contractual arrangements.

Supplemental disclosure of non-cash investing and financing activities

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

September 30, December 31, September 30, December 31,

(In millions) 2024

5 unchanged sentences

The outcome of any such proceedings, regardless of the merits, is inherently uncertain.

If the Company were unable to prevail in any such proceedings, its consolidated financial position, results of operations, and future cash flows may be materially impacted.

If the Company is unable to prevail in one or more of such proceedings, its consolidated financial position, results of operations, and future cash flows may be materially adversely impacted.

Costs associated with the Company's involvement in legal proceedings are expensed as incurred.

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

As of September 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.

10 unchanged sentences

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

A trial has been scheduled to begin in November 2024.

An oral hearing on Amgen's motion for summary judgment has been scheduled for November 20, 2024.

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.

4 unchanged sentences

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

On September 16, 2024, Amgen appealed the decision of the Munich Central Division of the UPC to the Court of Appeal of the UPC.

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.

13 unchanged sentences

and Celltrion

IPR petitions seeking declarations of invalidity May 5, 2021 On November 9, 2022, the USPTO issued final written decisions finding that the challenged claims of the '338 and '069 Patents are unpatentable and, therefore, invalid.

IPR petitions seeking declarations of invalidity

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

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").

3 unchanged sentences

('601 Patent)

IPR petitions seeking declarations of invalidity July 1, 2022

IPR petitions seeking declarations of invalidity

On January 9, 2024, the USPTO issued final written decisions finding that that the challenged claims of the '681 and '601 Patents are unpatentable and, therefore, invalid.

On March 12, 2024, the Company filed notices of appeal of these decisions to the Federal Circuit.

On August 20, 2024, the Company's appeal was voluntarily dismissed.

Samsung Bioepis, joined by Biocon Biologics Inc.

('601 Patent)

IPR petitions seeking declarations of invalidity January 6, 2023 ('681 Patent)

IPR petitions seeking declarations of invalidity

January 6, 2023 ('681 Patent)

March 26, 2023 ('601 Patent)

7 unchanged sentences

Patent Litigation

On August 2, 2022, the Company filed a patent infringement lawsuit against Mylan, a wholly-owned subsidiary of Viatris Inc., in the United States District Court for the Northern District of West Virginia alleging that Mylan's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents.

Food and Drug Administration ("FDA") approval of an aflibercept 2 mg biosimilar infringes certain Company patents.

On April 20, 2023, Mylan filed a motion for summary judgment or partial summary judgment concerning four of the asserted patents.

11 unchanged sentences

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.

An oral hearing concerning the respective notices of appeal of Samsung Bioepis and Formycon has been scheduled for December 5, 2024.

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.

1 unchanged sentence

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.

An oral hearing before the United States District Court for the Northern District of West Virginia was held on August 13, 2024.

On September 23, 2024, the court denied the Company's motion for a preliminary injunction, and the Company filed (i) a notice of appeal of such decision to the Federal Circuit, (ii) a motion for an immediate administrative stay, and (iii) a motion for a temporary injunction preventing Amgen from launching its aflibercept 2 mg biosimilar during the pendency of such appeal.

On September 25, 2024, the Federal Circuit issued an administrative stay pending its review of the Company's temporary injunction motion.

On October 22, 2024, the Federal Circuit denied the Company's temporary injunction motion, lifted the administrative stay, and indicated that an expedited oral hearing on the Company's appeal to the Federal Circuit will be held in January 2025.

On August 26, 2024, the Company filed a patent infringement lawsuit against Sandoz Inc.

in the United States District Court for the District of New Jersey alleging that Sandoz's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents.

On September 12, 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 paragraphs.

Post-Grant Proceedings

9 unchanged sentences

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

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

Amgen and three anonymous parties Opposition proceedings May 5–10, 2023

Oral hearing to be scheduled

EPO European Patent No.

9 unchanged sentences

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

Invalidation proceedings and declaration of non-infringement by challenger's aflibercept 2 mg biosimilar

September 11, 2024

Trial has been scheduled to begin in June 2025

Samsung Bioepis UK Limited

Invalidation proceedings and declaration of non-infringement by challenger's aflibercept 2 mg biosimilar

October 2, 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.

Amgen Invalidation proceedings May 13, 2024 Stayed pending final resolution of the '992 Patent 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.

6 unchanged sentences

July 24, 2024

Trial to be scheduled.

Proceedings against Viatris Canada and BCIL

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.

Stayed pending final resolution of the '992 Patent EPO opposition proceedings listed above

Judicial Court of Paris

French designation of the '691 Patent and '306 Patent Formycon AG Invalidation proceedings and declaration of non-infringement by challenger's aflibercept 2 mg biosimilar August 19, 2024 Trial to be scheduled

Proceedings against Amgen Canada

9 unchanged sentences

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 hearing on the motion to delist the '276 Patent has 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

On January 15, 2024, the Company and Bayer Inc.

filed patent infringement lawsuits against Celltrion, Inc., Celltrion Healthcare Co, Ltd., Celltrion Pharma Inc., and Celltrion Healthcare Canada Ltd.

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

On March 6, 2024, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Apotex Inc.

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.

Proceedings against Samsung

On August 1, 2024, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Samsung Bioepis Co., Ltd.

3,137,326 (the "'326 Patent").

On October 28, 2024, the Company, Bayer Inc., Bayer Healthcare LLC, and Samsung Bioepis Co., Ltd.

entered into a settlement agreement concerning these patent infringement lawsuits, pursuant to which each such lawsuit will be dismissed and Samsung will generally be 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 (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 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.

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

Set forth below is a summary of patent infringement lawsuits filed by the Company and, as applicable, Bayer Consumer Care AG before the Seoul Central District Court based on allegations that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar by the relevant defendant(s) would infringe one or more claims of the Company's patents listed below.

Company Patent(s)

Relief Sought

Date of Action

Korean Patent No.

659477 (the "'477 Patent")

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

Samsung Bioepis Co., Ltd.

and its parent company Samsung Biologics Co., Ltd.

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.

January 16, 2023

Sam Chun Dang Pharm.

and OPTUS Pharmaceutical Co., Ltd

January 8, 2024

'477 Patent, '811 Patent, and Korean Patent No.

2519234 (the "'234 Patent")

Celltrion Inc.

Damages and injunctive relief

January 10, 2024

'811 Patent and '234 Patent

Sam Chun Dang Pharm.

and OPTUS Pharmaceutical Co., Ltd

Damages and injunctive relief

Samsung Bioepis Co., Ltd., its parent company Samsung Biologics Co., Ltd., and Samil Pharmaceuticals Co., Ltd

Injunctive relief

Samsung Bioepis Co., Ltd., its parent company Samsung Biologics Co., Ltd., and Samil Pharmaceuticals Co., Ltd.

Injunctive relief

July 30, 2024

Celltrion Inc.

and Kukje Pharmaceuticals, Inc.

Injunctive relief

July 30, 2024

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.

An oral hearing was held on August 6, 2024.

On September 23, 2024, the Federal Circuit affirmed the PTAB's decision invalidating all claims of the '631 Patent.

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").

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

On January 25, 2021, the Company filed an amended complaint seeking a judgment that Novartis's conduct violates Section 2 of the Sherman Antitrust Act based on additional grounds, as well as a judgment of tortious interference with contract.

On January 25, 2021, the Company filed an amended complaint seeking a

judgment that Novartis's conduct violates Section 2 of the Sherman Antitrust Act based on additional grounds, as well as a judgment of tortious interference with contract.

On February 22, 2021, Novartis filed, and Vetter moved to join, a motion to dismiss the amended complaint.

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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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and (iii) whether any use referred to in clause (ii) above was willful.

On October 4, 2024, the court granted Allele's motion for summary judgment and found that the safe harbor defense under federal law does not apply to Regeneron's use of the invention covered, based on the court's claim construction, by the '221 Patent.

A trial date has not yet been scheduled.

Department of Justice Matters

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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.

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

On September 1, 2023, the Company filed a second motion to dismiss the amended complaint or, in the alternative, a motion for judgment on the pleadings.

A trial has been scheduled for April 2025.

On July 31, 2024 and August 15, 2024, respectively, the District Court granted the Company's second motion to dismiss the amended

complaint with respect to the remaining causes of action under federal law and declined to exercise supplemental jurisdiction over the remaining causes of action under state law.

On August 26, 2024, the qui tam plaintiffs filed a notice of appeal.

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

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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.

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

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

An oral hearing has been scheduled for December 16, 2024.

California Department of Insurance Subpoena

28 unchanged sentences

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

On October 22, 2024, the Company filed a motion to transfer the proceedings to the U.S.

District Court for the District of Massachusetts or, in the alternative, to stay the proceedings or dismiss the proceedings.

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