Organon reports $1.57 billion revenue for Q3 2026

Cover page 2 changes

3 unchanged paragraphs

For the quarterly period ended June September 30, 2026

22 unchanged paragraphs

The number of shares of common stock outstanding as of the close of business on July 24, October 23, 2026: 262,609,433 262,621,584

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Financial statements 112 changes

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June 30, Six Months Ended

Revenues $ 1,558 $ 1,594 $ 3,018 $ 3,107

Cost of sales 711 720 1,388 1,392

Gross profit 847 874 1,630 1,715

Selling, general and administrative 434 453 858 873

Research and development 90 95 183 191

Interest expense 108 131 219 255

Exchange losses (gains) 2 ( 1 ) 9 ( 5 )

Other expense (income), net 29 ( 35 ) ( 67 ) ( 23 )

Income before income taxes 183 229 396 330

Income tax expense 75 84 142 98

Net income $ 108 $ 145 $ 254 $ 232

Basic $ 0.41 $ 0.56 $ 0.97 $ 0.90

Diluted $ 0.40 $ 0.56 $ 0.95 $ 0.89

September 30, Nine Months Ended

Revenues $ 1,574 $ 1,602 $ 4,592 $ 4,709

Cost of sales 705 745 2,093 2,137

Gross profit 869 857 2,499 2,572

Selling, general and administrative 421 415 1,279 1,288

Research and development 83 84 266 275

Acquired in-process research and development and milestones 1 1 6

Restructuring costs 2 31 88

Interest expense 106 128 325 383

Exchange losses 6 17 15 12

Other income, net ( 2 ) ( 30 ) ( 69 ) ( 53 )

Income before income taxes 255 243 651 573

Income tax expense 91 83 233 181

Net income $ 164 $ 160 $ 418 $ 392

Basic $ 0.62 $ 0.61 $ 1.60 $ 1.51

Diluted $ 0.60 $ 0.61 $ 1.56 $ 1.50

1 unchanged paragraph

Basic 262,611 259,939 261,497 258,906

Diluted 270,449 260,156 266,679 260,584

Basic 262,616 259,975 261,874 259,266

Diluted 272,384 260,653 268,585 260,611

3 unchanged paragraphs

June 30, Six Months Ended

Net income $ 108 $ 145 $ 254 $ 232

September 30, Nine Months Ended

Net income $ 164 $ 160 $ 418 $ 392

Other Comprehensive (Loss) Income (Loss), Net of Taxes:

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Comprehensive income $ 99 $ 190 $ 233 $ 309

Total other comprehensive income (loss), net of taxes 9 ( 2 ) ( 12 ) 75

Comprehensive income $ 173 $ 158 $ 406 $ 467

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June September 30, 2026 December 31, 2025

Cash and cash equivalents $ 1,132 1,455 $ 574

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Inventories (excludes inventories of $ 273 283 in 2026 and $ 236 in 2025 classified in Other assets)

Other current assets 1,136 1,079 1,033

1 unchanged paragraph

Total Current Assets 5,111 5,369 4,352

Property, plant and equipment, net 1,281 1,286 1,303

1 unchanged paragraph

Intangibles, net 1,112 1,065 1,130

Other assets 1,521 1,528 1,539

1 unchanged paragraph

Total Assets $ 13,178 13,401 $ 12,867

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Trade accounts payable 1,051 952

Trade accounts payable 982 952

Accrued and other current liabilities 1,407 1,522 1,335

Income taxes payable 84 79 85

1 unchanged paragraph

Total Current Liabilities 2,616 2,652 2,390

Long-term debt 8,479 8,485 8,628

Deferred income taxes 51 45 57

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Total Liabilities 12,172 12,208 12,115

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Issued and outstanding - 262,609 262,622 in 2026 and 260,316 in 2025

1 unchanged paragraph

Accumulated other comprehensive loss ( 548 539 ) ( 527 )

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Balance at April 1, 2025 257,950 $ 3 $ 130 $ 1,026 $ ( 617 ) $ 542

Balance at July 1, 2025 259,965 $ 3 $ 139 $ 1,163 $ ( 572 ) $ 733

Other comprehensive income, loss, net of taxes ( 2 ) ( 2 )

1 unchanged paragraph

Balance at June 30, 2025 259,965 $ 3 $ 139 $ 1,163 $ ( 572 ) $ 733

Balance at April 1, 2026 262,649 $ 3 $ 186 $ 1,253 $ ( 539 ) $ 903

Stock-based compensation plans and other 2,015 9 9 18 20 20

Balance at September 30, 2025 259,983 $ 3 $ 159 $ 1,318 $ ( 574 ) $ 906

Balance at July 1, 2026 262,609 $ 3 $ 199 $ 1,352 $ ( 548 ) $ 1,006

Other comprehensive loss, income, net of taxes 9 9

1 unchanged paragraph

Balance at June 30, 2026 262,609 $ 3 $ 199 $ 1,352 $ ( 548 ) $ 1,006

Stock-based compensation plans and other ( 40 ) 13 13 19 19

Balance at September 30, 2026 262,622 $ 3 $ 218 $ 1,511 $ ( 539 ) $ 1,193

1 unchanged paragraph

Balance at June 30, 2025 259,965 $ 3 $ 139 $ 1,163 $ ( 572 ) $ 733

Other comprehensive income, net of taxes 77 77 75 75

Cash dividends declared on common stock ($ 0.30 0.32 per share)

Stock-based compensation plans and other 2,166 31 31 2,184 51 51

Balance at September 30, 2025 259,983 $ 3 $ 159 $ 1,318 $ ( 574 ) $ 906

2 unchanged paragraphs

Balance at June 30, 2026 262,609 $ 3 $ 199 $ 1,352 $ ( 548 ) $ 1,006

Cash dividends declared on common stock ($ 0.04 0.06 per share)

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and 32 more changes in the filing

Note 1: Background and Nature of Operations 3 changes

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Women s Health : Organon s health portfolio of products is sold by prescription primarily in two therapeutic areas: contraception, with key brands such as Nexplanon (etonogestrel implant) (sold as Implanon NXT in some countries outside the United States) and NuvaRing (etonogestrel / ethinyl estradiol vaginal ring); and fertility, with key brands such as Follistim AQ (follitropin beta injection) (marketed in most countries outside the United States as Puregon ). Nexplanon is a long-acting reversible contraceptive in a class recognized as one of the most effective types of hormonal contraception available to patients with a low long-term average cost. The Jada 2 device is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. In January 2026, the Company divested the Jada System to Laborie Medical Technologies Corporation ( Laborie ).

1 unchanged paragraph

Biosimilars : Organon s current biosimilars portfolio spans across immunology and oncology related treatments. Organon s oncology biosimilars: Ontruzant (trastuzumab-dttb), Aybintio TM1 (bevacizumab), Bildyos (denosumab-nxxp) and Bilprevda (denosumab-nxxp) have been launched in more than 20 countries. Organon s immunology biosimilars consist of: Brenzys TM1 (etanercept), Renflexi s (infliximab-abda), Hadlima (adalimumab-bwwd) and Tofidence (tocilizumab-bavi). Brenzys , Renflexis , and Hadlima have been launched in five countries. In 2025, Organon launched Bildyo s injection 60 mg/mL and Bilprevda injection 120 mg/1.7 mL, biosimilars to Prolia 2 (denosumab) and Xgeva 2 (denosumab), respectively, in the United States. In 2025, Poherdy (pertuzumab-dpzb) was approved by the U.S. Food and Drug Administration ( FDA ). and The Company is assessing the timing of the future commercial launch of this product.

1 unchanged paragraph

On April 26, 2026, the Company entered into a definitive agreement with Sun Pharmaceutical Industries Limited ( Sun Pharma ) under which Sun Pharma will acquire all of the Company s outstanding shares of common stock for $ 14.00 per share in cash. Completion of the transaction is subject to customary closing conditions, including receipt of required regulatory approvals and approval by the Company s stockholders. On July 23, 2026, the Company received stockholder approval at its special meeting of stockholders . The transaction is expected to close in by early 2027.

Note 3: Acquisitions and Licensing Arrangements 2 changes

2 unchanged paragraphs

In April 2026, the European Commission granted marketing authorization for Poherdy (pertuzumab) 420 mg/14 mL injection for intravenous use, the first and only approved biosimilar to Perjeta 2 (pertuzumab) in Europe, for all indications of the product. As a result, sales-based milestones related to the Henlius agreement were determined to be probable of being achieved and the Company recognized intangible assets of $ 10 million related to these milestones.

1 unchanged paragraph

On February 19, 2026, Organon entered into an exclusive license agreement with Sebela for the global rights to Miudella , copper intrauterine system, a hormone-free copper intrauterine device ( IUD ) that was approved by the FDA on February 24, 2025. Under the terms of the agreement, Organon paid $ 27.5 million in June 2026, with potential sales-based milestone payments of up to $ 505 million, and tiered double-digit royalties based on net sales. In the second quarter of 2026, the Company recognized an intangible asset of $ 27.5 million. The intangible assets will be amortized over 8 years.

Note 4: Earnings per Share ( EPS ) 13 changes

1 unchanged paragraph

June 30, Six Months Ended

September 30, Nine Months Ended

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Net income $ 108 $ 145 $ 254 $ 232

Diluted weighted average common shares outstanding 270,449 260,156 266,679 260,584

Basic $ 0.41 $ 0.56 $ 0.97 $ 0.90

Diluted $ 0.40 $ 0.56 $ 0.95 $ 0.89

Net income $ 164 $ 160 $ 418 $ 392

Basic weighted average number of shares outstanding 262,611 259,939 261,497 258,906 262,616 259,975 261,874 259,266

Stock awards and equity units (share equivalent) 7,838 217 5,182 1,678 9,768 678 6,711 1,345

Diluted weighted average common shares outstanding 272,384 260,653 268,585 260,611

Basic $ 0.62 $ 0.61 $ 1.60 $ 1.51

Diluted $ 0.60 $ 0.61 $ 1.56 $ 1.50

Anti-dilutive shares excluded from the calculation of EPS 9,337 18,568 9,029 17,761 6,781 16,238 6,765 15,871

1 unchanged paragraph

Note 5: Product and Geographic Information 47 changes

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Three Months Ended June 30, Six Months Ended June 30,

Nexplanon/Implanon NXT $ 129 $ 101 $ 230 $ 163 $ 77 $ 240 $ 256 $ 175 $ 431 $ 339 $ 148 $ 488

Follistim AQ 17 43 59 30 43 74 38 82 120 65 77 142

Three Months Ended September 30, Nine Months Ended September 30, ($ in millions) U.S. Int l Total U.S. Int l Total U.S. Int l Total U.S. Int l Total

Nexplanon/Implanon NXT $ 127 $ 73 $ 200 $ 146 $ 77 $ 223 $ 383 $ 248 $ 631 $ 486 $ 225 $ 711

Follistim AQ 32 35 67 24 40 64 70 117 188 89 117 206

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Renflexis 44 21 65 46 17 63 87 36 122 90 30 120

Hadlima 55 24 79 36 14 50 106 40 146 69 27 96

Ontruzant 5 1 6 5 26 31 9 2 11 8 41 49

Brenzys 14 14 22 22 34 34 36 36

Bildyos/Bilprevda 14 5 19 20 15 35

Renflexis 46 21 67 51 19 70 133 57 190 141 49 190

Hadlima 62 24 86 47 16 63 168 64 231 116 44 159

Ontruzant 4 3 7 4 28 31 13 5 18 12 68 80

Brenzys 22 22 23 23 56 56 59 59

Bildyos/Bilprevda 17 7 24 3 3 37 23 60 3 3

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Atozet 80 80 86 86 165 165 162 162

Zetia 2 95 96 1 72 74 3 181 183 3 156 159

Cozaar/Hyzaar 2 48 50 2 54 56 5 103 107 4 107 111

Vytorin 1 20 21 1 26 27 2 40 42 2 48 50

Atozet 85 85 95 95 250 250 257 257

Zetia 1 100 101 1 91 93 4 280 284 4 248 252

Cozaar/Hyzaar 2 49 51 2 53 55 6 152 158 6 160 166

Vytorin 1 24 25 1 25 25 4 64 68 3 72 75

Rosuzet 5 5 6 6 11 11 10 10 16 16 16 16

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Singulair 2 46 48 2 64 66 4 84 88 4 136 140

Nasonex 58 58 66 66 123 123 137 137

Dulera 30 11 41 32 9 41 53 23 76 66 19 84

Clarinex 1 30 30 1 33 34 2 60 61 1 67 68

Singulair 2 43 45 2 51 53 6 127 132 6 187 193

Nasonex 65 65 60 60 188 188 197 197

Dulera 25 10 35 24 10 34 78 33 111 89 28 118

Clarinex 23 23 1 25 25 2 83 85 1 92 93

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Arcoxia 69 69 63 63 128 128 124 124

Fosamax 1 24 25 34 34 1 53 54 2 65 67

Diprospan 44 44 41 41 79 79 71 71

Arcoxia 69 69 71 71 197 197 195 195

Fosamax 1 28 28 40 40 2 80 82 2 106 107

Diprospan 42 42 41 41 121 121 112 112

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Propecia 2 34 36 1 30 32 3 62 65 3 55 58

Emgality 54 54 42 42 108 108 74 74

Proscar 20 20 22 22 46 46 46 46

Revenues $ 398 $ 1,160 $ 1,558 $ 414 $ 1,180 $ 1,594 $ 756 $ 2,262 $ 3,018 $ 826 $ 2,281 $ 3,107

Propecia 1 40 41 2 31 33 4 102 106 4 86 90

Emgality 59 59 51 51 166 166 125 125

Proscar 22 22 27 27 1 68 69 1 73 73

Revenues $ 411 $ 1,163 $ 1,574 $ 406 $ 1,196 $ 1,602 $ 1,167 $ 3,425 $ 4,592 $ 1,232 $ 3,477 $ 4,709

4 unchanged paragraphs

Note 6: Stock-Based Compensation Plans 16 changes

2 unchanged paragraphs

June 30, Six Months Ended

September 30, Nine Months Ended

2 unchanged paragraphs

Selling, general and administrative 16 14 29 30

Research and development 5 4 8 8

Total $ 25 $ 22 $ 44 $ 46

Cost of sales $ 4 $ 4 $ 7 11 $ 8 12

Selling, general and administrative 14 16 43 46

Research and development 3 4 11 12

Total $ 21 $ 24 $ 65 $ 70

Income tax benefits $ 5 $ 5 $ 9 14 $ 10 15

1 unchanged paragraph

Six Months Ended June 30,

Nine Months Ended September 30,

Expected dividend yield 7.41 % (1)

2 unchanged paragraphs

Expected life (years) (1) (2)

(1) The expected dividend yield assumption is based on the Company's expected dividend payments at the grant date.

(1) (2) The expected term was estimated using the historical option exercise and settlement patterns, supplemented by a midpoint based assumption applied to awards meeting a one year post grant eligibility filter.

Note 7: Restructuring 5 changes

During the first quarter of 2026, the Company implemented restructuring initiatives that will result resulted in an approximate 3 % headcount reduction, to streamline and optimize the Company's research and development and manufacturing operations, focusing on enhancing efficiency and aligning resources with strategic priorities. The Restructuring costs primarily consist of employee termination benefits and other associated expenses.

2 unchanged paragraphs

June September 30, 2026 December 31, 2025

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Ending balance $ 16 $ 8

Cash payments and other ( 23 37 ) ( 101 )

Ending balance $ 2 $ 8

1 unchanged paragraph

Note 8: Taxes on Income 1 change

The effective income tax rates were 41.3 35.7 % and 37.0 34.0 % for the three months ended June September 30, 2026 and 2025, respectively, and 36.0 35.8 % and 29.8 31.6 % for the six nine months ended June September 30, 2026 and 2025, respectively. These effective income tax rates reflect the beneficial impact of foreign earnings, offset by the impact of U.S. inclusions under the Global Intangible Low-Taxed Income regime and a valuation allowance recorded against non-deductible U.S. interest expense. Also included in the six nine month tax rate is the beneficial impact of the sale of the Jada System. . There was a favorable impact to the 2025 year-to-date effective tax rate driven by a tax amortization benefit.

1 unchanged paragraph

Note 9: Inventories 11 changes

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Finished goods $ 686 $ 751

Other assets 273 236

($ in millions) June September 30, 2026 December 31, 2025

Finished goods $ 702 $ 751

Work in process 845 843 791

Total (approximates current cost) $ 1,621 1,636 $ 1,637

Increase (Decrease) to last in, first out ( LIFO ) costs

Inventories $ 1,351 1,355 $ 1,406

Other assets 283 236

1 unchanged paragraph

In connection with the Jada divestiture of Jada in January 2026, $ 8 million of inventory was reclassified to Assets held for sale on the Consolidated Balance Sheet as of December 31, 2025.

As part of the Dermavant Sciences Ltd. ( Dermavant ) acquisition in 2024, the Company acquired $ 97 million of inventory, which included a $ 63 million purchase accounting inventory fair value adjustment. As of June September 30, 2026, the amount has been fully expensed. As of December 31, 2025, there was $ 7 million remaining in inventory related to the fair value adjustment.

1 unchanged paragraph

Note 10: Long-Term Debt and Short-Term Borrowings 10 changes

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($ in millions) June September 30, 2026 December 31, 2025

11 unchanged paragraphs

Other (discounts and debt issuance costs) ( 72 67 ) ( 81 )

Total principal long-term debt and short-term borrowings $ 8,553 8,554 $ 8,644

Less: Current portion of long-term debt and short-term borrowings 74 69 16

Total Long-term debt, net of current portion $ 8,479 8,485 $ 8,628 (1) Recognized at the amortized cost basis. The remaining principal is determined as the initial fair value less principal payments. As of June September 30, 2026, the remaining principal of the revenue interest purchase and sale agreement (the RIPSA ) that the Company assumed in connection with its 2024 acquisition of Dermavant is $ 156 million.

1 unchanged paragraph

On February 6, 2026, the Company made mandatory prepayments from the proceeds of the Jada System divestiture of Jada of $ 20.4 million on the U.S. Dollar Term Loans and 9.6 million on the Euro Term Loan Facility. Additional mandatory prepayments totaling $ 55 million are required across the Company s senior secured notes within 450 days of the January 2026 closing of the Jada System divestiture of Jada .

For the six nine months ended June September 30, 2026, the Company had no borrowings or repayments on the Company s Revolving Credit Facility (the Revolving Credit Facility ). There were no outstanding balances under the Revolving Credit Facility as of June September 30, 2026 or December 31, 2025.

1 unchanged paragraph

($ in millions) Fair Value Measurement Level June September 30, 2026 December 31, 2025

Long-term debt - RIPSA 3 134 141 136

1 unchanged paragraph

The Company made interest payments related to its debt instruments of $ 209 244 million for the six nine months ended June September 30, 2026. The average maturity of the Company s long-term debt as of June September 30, 2026 is approximately 4.1 3.8 years and the weighted-average interest rate on total borrowings as of June September 30, 2026 is 4.9 5.0 %.

Note 11: Financial Instruments 6 changes

2 unchanged paragraphs

($ in millions) Fair Value Measurement Level June September 30, 2026 December 31, 2025

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Forward contracts 2 $ 16 12 $ 12

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Forward contracts 2 18 22 11

1 unchanged paragraph

Contingent consideration 3 273 263 269

Cross-currency swap 2 58 44 82

(a) As part of the divestiture of the Jada System in January 2026, the Company is eligible to receive potential contingent consideration based on the achievement of certain net sales targets for the Jada System during 2026. See Note 3. Acquisitions and Licensing Arrangements for further information.

2 unchanged paragraphs

Note 12: Accumulated Other Comprehensive Income (Loss) 15 changes

3 unchanged paragraphs

Comprehensive (Loss) Income

Balance at June 30, July 1, 2025, net of taxes $ ( 17 ) $ ( 555 ) $ ( 572 )

Other comprehensive loss, pretax ( 9 2 ) ( 9 2 )

Other comprehensive loss, net of taxes ( 9 2 ) ( 9 2 )

Balance at April 1, September 30, 2025, net of taxes $ ( 17 ) $ ( 600 557 ) $ ( 617 574 )

Balance at June 30, July 1, 2026, net of taxes $ 5 $ ( 553 ) $ ( 548 )

Other comprehensive income, pretax 45 45 9 9

Other comprehensive income, net of taxes 45 45 9 9

Balance at April 1, September 30, 2026, net of taxes $ 5 $ ( 544 ) $ ( 539 )

1 unchanged paragraph

Other comprehensive income, pretax 77 77 75 75

Other comprehensive income, net of taxes 77 77 75 75

Balance at June September 30, 2025, net of taxes $ ( 17 ) $ ( 555 557 ) $ ( 572 574 )

1 unchanged paragraph

Other comprehensive income (loss), pretax 1 ( 22 13 ) ( 21 12 )

Other comprehensive income (loss), net of taxes 1 ( 22 13 ) ( 21 12 )

Balance at June September 30, 2026, net of taxes $ 5 $ ( 553 544 ) $ ( 548 539 )

Note 14: Third-Party Arrangements 2 changes

1 unchanged paragraph

The Separation was completed pursuant to the Separation and Distribution Agreement and other agreements with Merck related to the Separation. As of June September 30, 2026, only one jurisdiction remains under an interim operating model agreement.

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($ in millions) June September 30, 2026 December 31, 2025

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Note 15: Contingencies 2 changes

6 unchanged paragraphs

Merck is a defendant in product liability lawsuits in the United States involving Fosamax (alendronate sodium) (the Fosamax Litigation ). As of June September 30, 2026, the Fosamax Litigation comprises consisted of approximately 498 cases in Federal court, approximately 1,478 cases in New Jersey state court, one case in Pennsylvania state court and approximately 149 cases in California state court. Plaintiffs in the vast majority of these cases generally allege that they sustained femur fractures and/or other bone injuries ( Femur Fractures ) associated with the use of Fosamax .

1 unchanged paragraph

In New Jersey state court, the cases have been consolidated before a single judge in Middlesex County. On July 28, 2025, the Company entered into a Master Settlement Agreement with the New Jersey state and federal plaintiffs lawyers who represent eligible clients ( NJ MSA Attorneys ), pursuant to which, in exchange for a confidential, but non-material settlement payment, at least 95 % of the NJ MSA Attorneys eligible clients will release the Company and Merck from any liability related to their filed claims.

Notes to the financial statements 4 changes

1 unchanged paragraph

Merck is a defendant in lawsuits brought by individuals relating to the use of Nexplanon and Implanon (etonogestrel implant). There are two filed product liability actions involving Implanon , both of which are pending in the Northern District of Ohio as well as 56 unfiled cases involving Implanon alleging similar injuries, all of which have been tolled under a written tolling agreement. There is one matter involving Nexplanon pending in California state court. On March 12, 2026, the Company signed a Master Settlement Agreement with the attorneys representing plaintiffs and all but two of the claimants with unfiled cases, pursuant to which, in exchange for a confidential, but non-material settlement payment, 56 plaintiffs and claimants will release the defendant parties from any liability for their filed and unfiled claims. As of June September 30, 2026, Merck had 19 18 of such cases pending outside the United States, of which seven six relate to Implanon and twelve relate to Nexplanon .

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The court consolidated the securities class actions on March 6, 2026 and appointed Teamsters Local 710 Pension Fund (the Lead Plaintiff ) as the lead plaintiff. On May 8, 2026, the Lead Plaintiff filed an amended complaint that contained allegations similar to those raised in the complaints filed in the original, individual actions. The amended complaint also raised allegations relating to the Nexplanon matter (defined below). The amended complaint seeks unspecified monetary damages. On May 29, 2026, the Lead Plaintiff informed the defendants that it intended to file a second amended complaint and on June 17, 2026, the court entered an order setting the Company s time to answer, move or otherwise respond as 60 days from the later of the date on which the court denies the Lead Plaintiff s motion to file a second amended complaint or the date on which the Lead Plaintiff files a second amended complaint. On July 17, 2026, the Lead Plaintiff filed its motion for leave to file a second amended complaint. The Company filed a motion in opposition to the Lead Plaintiff s motion on August 17, 2026 and the Lead Plaintiff filed its reply to this opposing motion on September 10, 2026.

The same conduct alleged misconduct in the individual securities complaints also forms the basis of two stockholder derivative lawsuits filed on June 11, 2025 and June 17, 2025, respectively, against the Company, and certain of its officers and directors asserting breach of fiduciary duties arising from purportedly materially false and misleading statements. On July 7, 2025, the court consolidated each of the these two stockholder derivative lawsuits. Subsequently, on September 8, 2025, the court stayed the proceedings pending the final resolution of all motions to dismiss filed in the securities lawsuits. On September 19, 2026, a third stockholder derivative suit was filed which contained allegations similar to those raised in the first amended complaint in the securities lawsuit.

3 unchanged paragraphs

On October 26, 2025, Organon made a voluntary self-disclosure to the U.S. Securities and Exchange Commission (the SEC ) to advise it of an investigation conducted by the Audit Committee of the Company s Board of Directors (the Audit Committee ) regarding the Company s Nexplanon sales to certain wholesalers in the United States (the Nexplanon Matter ).

MD&A 141 changes

1 unchanged paragraph

Some statements and disclosures in this document are forward-looking statements. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as may, believe, will, expect, project, potential, possible, probable, outcome, likely, could, should, estimate, anticipate, plan, intend, would, future, target, seek, continue, and other words of similar meaning, or negative variations of any of the foregoing. These forward-looking statements are based on our current plans and expectations and are subject to a number of risks and uncertainties that could cause our plans and expectations, including actual results, to differ materially from the forward-looking statements. Risks and uncertainties that may affect our future results include, but are not limited to, uncertainties as to the timing of the proposed transaction with Sun Pharmaceutical Industries Limited (together with its subsidiaries and/or associated companies, Sun Pharma ); the risk that the proposed transaction may not be completed on the anticipated terms in a timely manner or at all; the possibility that competing offers or acquisition proposals for Organon will be made; the possibility that any or all of the remaining conditions to the consummation of the proposed transaction may not be satisfied or waived, including the failure to receive any remaining required regulatory approvals from any applicable governmental entities (or any conditions, limitations or restrictions placed on such approvals); the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive agreement, including in circumstances that would require us to pay a termination fee; the effect of the pendency of the proposed transaction on our ability to retain and hire key personnel, our ability to maintain relationships with our customers, suppliers and others with whom we do business, or our operating results and business generally; risks related to diverting management s attention from our ongoing business operations; the risk that stockholder litigation in connection with the proposed transaction may result in significant costs of defense, indemnification and liability; certain restrictions during the pendency of the proposed transaction that may impact our ability to pursue certain business opportunities or strategic transactions; the risk that any announcements relating to the proposed transaction could have adverse effects on the market price of our common stock, including if the proposed transaction is not consummated; risks that the benefits of the proposed transaction are not realized when and as expected; the possibility that competing offers or acquisition proposals for Organon will be made; expanded brand and class competition in the markets in which we operate; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including pharmaceutical sector tariffs), trade sanctions or similar restrictions by the United States or other governments; changes in U.S. and foreign federal, state and local governmental funding allocations including the timing and amounts allocated to our customers and business partners; the impact of global business, political and macroeconomic conditions, including inflation, interest rate fluctuations, recessionary pressures, foreign currency exchange rates, volatile market conditions, and instability in the global banking system; global events, such as regional conflicts in the Middle East and elsewhere, including any resulting disruptions to manufacturing supply chains, distribution networks, logistics providers, raw material sourcing, or transportation; our ability to access the public securities and other capital and credit markets in accordance with our financial plans, the cost of such capital, and overall condition of the capital and credit markets; our ability to refinance or repay indebtedness maturing in 2028 if the proposed transaction is not completed, and the resulting impact on our liquidity, financial condition and ability to continue as a going concern; actions that may be taken by credit rating agencies that could negatively affect either our access to or terms of financing or our financial condition and liquidity; our ability to meet our revenue and growth expectations and outlook; our ability to retain members of our senior management and other key employees; the failure of any supplier to provide substances, materials, or services as agreed, or otherwise meet their obligations to us; manufacturing performance issues at Company-owned and third-party facilities, operational disruptions, labor-related disruptions, or geopolitical events that affect the manufacture, supply, distribution, or availability of our products, the increased cost of supply, manufacturing, packaging, and operations, including as a result of volatility in commodity prices, fuel costs and shipping rates; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as our products lose patent protection; any failure by us to retain market exclusivity for Nexplanon or to obtain an additional period of exclusivity in the United States for Nexplanon subsequent to the expiration of the rod patents in 2027; the success of our efforts to adapt our business and sales strategies to address the changing market and regulatory landscape in order to achieve our business objectives and remain competitive; restructurings or other disruptions at the U.S. Food and Drug Administration ( FDA ), the SEC and other U.S. and comparable foreign government agencies; difficulties in connection with future strategic transactions, including as a result of the impact of macroeconomic or geopolitical developments; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to or affecting Medicare, Medicaid and healthcare reform, pharmaceutical pricing and reimbursement, access to our products, international reference pricing, including Most-Favored-Nation drug pricing, and other pricing-related initiatives and policy efforts; the impact of higher selling and promotional costs; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of our products and related intellectual property, environmental regulations, governmental agency staffing, operations and enforcement priorities, and the enforcement thereof affecting our business; efficacy, safety or other quality concerns with respect to our marketed products, whether or not scientifically justified, leading to product recalls, withdrawals, labeling changes, or declining sales; delays or failures to demonstrate adequate efficacy and safety of our product candidates in pre-clinical and clinical trials, which may prevent or delay the development, approval, clearance, or commercialization of our product candidates; reduced research and development investment and increased reliance on fewer research and development programs for new products to generate future revenue and replace existing products that come to the end of their market life cycle; future actions of third-parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of healthcare products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing healthcare insurance coverage; legal factors, such as product liability claims, stockholder litigation, governmental investigations, and patent disputes; lost market opportunity resulting from delays and uncertainties in clinical trials and the approval or clearance process of the FDA and other regulatory authorities; the failure by us or our third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations, which could lead to a delay in regulatory approval or commercial marketing of our products; cyberattacks on, or other failures, accidents, or security breaches of, our or third-party providers information technology systems, which could disrupt our operations and those of third parties upon which we rely; increased focus on privacy issues in countries around the world, including the United States, the European Union, and China, and a more difficult legislative and regulatory landscape for privacy and data protection that continues to evolve with the potential to directly affect our business, including recently enacted laws in a majority of states in the United States requiring security breach notification; changes in tax laws including changes related to the taxation of foreign earnings; the impact of any future pandemic, epidemic, or similar public health threat on our business, operations and financial performance; changes in accounting pronouncements promulgated by standard-setting or regulatory bodies, including the Financial Accounting Standards Board and the SEC, that are adverse to us; volatility of commodity prices, fuel, and shipping rates that impact the costs and/or ability to supply our products; and other factors discussed in our most recently filed Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and subsequent filings, including those discussed in the Business, Risk Factors, Cautionary Statement Regarding Forward-Looking Statements and Management s Discussion and Analysis of Financial Condition and Results of Operations sections of those reports.

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We are a global healthcare company with a primary focus on improving the health of women throughout their lives. We develop and deliver innovative health solutions through a portfolio of prescription therapies within our women s health and general medicines portfolios. We have a portfolio of more than 70 medicines and products across a range of therapeutic areas. We sell these products through various channels including drug wholesalers and retailers, hospitals, government agencies and managed healthcare providers such as health maintenance organizations, pharmacy benefit managers and other institutions. We own and operate six manufacturing facilities, which are located in Belgium, Brazil, Indonesia, Mexico, the Netherlands and the United Kingdom. Unless otherwise indicated, trademarks appearing in italics throughout this document are trademarks of, or are used under license by, our group of companies.

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On April 26, 2026, we entered into a definitive agreement with Sun Pharma under which Sun Pharma will acquire all of our outstanding shares of common stock for $14.00 per share in cash. Completion of the transaction is subject to customary closing conditions, including receipt of required regulatory approvals and approval by the Company s stockholders. On July 23, 2026, the Company received stockholder approval at its special meeting of stockholders. The Company and Sun Pharma are continuing to work to satisfy the other conditions to closing. The transaction is expected to close in by early 2027.

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On May 22, 2026, the Samsung Agreement was amended to include commercialization rights for Pyzchiva (ustekinumab biosimilar) in Canada. Samsung Bioepis retains full development, manufacturing, and regulatory responsibilities ( Amendment No. 8 ). Pyzchiva is expected to launch was launched in Canada in the second half third quarter of 2026.

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In connection with Amendment No. 9, the Company is we are required to make fixed payments totaling $30 million over a nine-year period from 2026 through 2034. The Company We recorded an intangible asset and corresponding liability of $20.8 million, the present value of the future payments. The intangible asset will be amortized over nine years.

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Amendment No. 9 also includes the return of commercialization rights to Samsung for certain oncology biosimilars, including Ontruzant and Aybintio , in specified ex U.S. markets such as Europe, Canada, and Brazil. These returns of rights are subject to defined, phased transition and cutover periods extending from 2026 through 2029, during which the Company we may continue to commercialize products and fulfill contractual obligations.

On June 2, 2026, the Samsung Agreement was amended to include commercialization rights for Epyztek in Australia. Samsung Bioepis retains full development, manufacturing, and regulatory responsibilities ( Amendment No. 10 ). Epyztek is expected to launch in Australia in the second first half of 2026. 2027.

On September 11, 2026, the Samsung Agreement was amended to include additional dosage forms of Pyzchiva in Canada ( Amendment No. 11 ).

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On February 19, 2026, we entered into an exclusive license agreement with Sebela for the global rights to Miudella , a hormone-free copper intrauterine device ( IUD ) that was approved by the FDA on February 24, 2025 and is estimated to launch commercials commercial sales in the United States in late 2026. Under the terms of the agreement, we paid $27.5 million in June 2026, with potential sales-based milestone payments of up to $505 million, and tiered double-digit royalties based on net sales. In the second quarter of 2026, the Company we recognized an intangible asset of $27.5 million.

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United States $ 398 $ 414 (4) % (4) % $ 756 $ 826 (8) % (8) %

International 1,160 1,180 (2) (5) 2,262 2,281 (1) (6)

Total $ 1,558 $ 1,594 (2) % (5) % $ 3,018 $ 3,107 (3) % (7) %

In January 2026, we divested the Jada System to Laborie for an aggregate payment of up to $465 million, comprised of consideration of $440 million, subject to certain closing adjustments, plus potential contingent consideration payments of up to $25 million based on the achievement of certain 2026 net sales targets. Approximately 100 Company employees transferred to Laborie as part of this transaction.

Upon the closing of the divestiture, we recognized a net gain on the sale of the Jada System of $81 million recognized in Other expense income, net in the Condensed Consolidated Statement of Income for the six nine months ended June September 30, 2026.

Three Months Ended June September 30, % Change % Change Excluding Foreign Exchange Six Nine Months Ended June September 30, % Change % Change Excluding Foreign Exchange ($ in millions) 2026 2025 2026 2025

United States $ 411 $ 406 1 % 1 % $ 1,167 $ 1,232 (5) % (5) %

International 1,163 1,196 (3) (4) 3,425 3,477 (1) (5)

Total $ 1,574 $ 1,602 (2) % (3) % $ 4,592 $ 4,709 (2) % (5) %

Worldwide sales were $1.6 billion for the three months ended June September 30, 2026, a decrease of 2%, compared to 2025. Worldwide sales were positively impacted by approximately $42 $12 million or 3%, 1%, due to favorable foreign exchange rates.

Excluding the impact of foreign exchange rates, sales decreases for the three months ended June September 30, 2026 primarily reflect the lower sales of:

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Singulair (montelukast sodium) , primarily attributable to decreased demand due to less favorable medical guidelines in certain international markets, most recently in China, as well as temporary supply constraints in Japan and mandatory price reductions in China and Japan; and

Nexplanon, primarily due to decreased physician demand in the United States following the five-year label approval as reinsertions have been delayed and there has been uncertainty around federal funding;

Jada, due to no longer having sales following the sale divestiture of the Jada System to Laborie in January 2026; and certain Established Brands products within international markets, due to temporary supply chain and operational disruptions affecting availability.

This performance was offset by sales increases for the three months ended June September 30, 2026 in:

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Zetia (ezetimibe) /Vytorin (ezetimibe / simvastatin) , primarily driven by increased demand in China; and

Bildyos/Bilprevda, as a result of the product launch in the third quarter of 2025; and

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Jada, due to no longer having sales following the sale of the Jada System to Laborie in January 2026.

Worldwide sales were $3.0 $4.6 billion for the six nine months ended June September 30, 2026, a decrease of 3%, 2%, compared to 2025. Worldwide sales during the six nine months ended June September 30, 2026 were positively impacted by approximately $118 $130 million, or approximately 4%, 3%, due to favorable foreign exchange rates.

Excluding the impact of foreign exchange rates, sales decreases for the six nine months ended June September 30, 2026, primarily reflect lower sales of:

Nexplanon, primarily due to decreased physician demand in the United States following the five-year label approval as reinsertions have been delayed and there has been uncertainty around federal funding partially offset by increased demand and access in Brazil;

Ontruzant, due to lower tendered volume from Brazil s Ministry of Health when compared with the same period in 2025; and

Singulair (montelukast) , primarily attributable to decreased demand due to less favorable medical guidelines in certain international markets, most recently in China, as well as temporary supply constraints in Japan and mandatory price reductions in China and Japan; and certain Established Brands products within international markets, due to temporary supply chain and operational disruptions affecting availability.

This performance was offset by sales increases for the six nine months ended June September 30, 2026 in:

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Zetia/Vytorin, primarily driven by increased demand in China.

Bildyos/Bilprevda, as a result of the product launch in the third quarter of 2025; and

Emgality, as a result of increased demand in various international markets. and

Loss of exclusivity ( LOE ) negatively impacted sales of certain of our products by approximately $6 $13 million and $10 $23 million during the three and six nine months ended June September 30, 2026, respectively, based on the decrease in sales volume of those products compared to 2025. Volume-based procurement ( VBP ) in China negatively impacted sales by approximately $5 $8 million and $7 $15 million during the three and six nine months ended June September 30, 2026, respectively. We expect VBP to continue to negatively impact our general medicines product portfolio for the next several quarters.

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Nexplanon/Implanon NXT $ 230 $ 240 (4) % (6) % $ 431 $ 488 (12) % (14) %

NuvaRing 27 28 (4) (8) 51 50 2 (5)

Marvelon/Mercilon 32 33 (4) (5) 58 72 (20) (22)

Follistim AQ 59 74 (19) (21) 120 142 (16) (18)

Jada 18 (100) (100) 5 33 (84) (84)

Worldwide sales of Follistim AQ , a fertility treatment, declined 19% and 16% for the three and six months ended June 30, 2026, compared to 2025, respectively, as a result of competitive-driven price reduction in the United States. We expect sales to continue to decline compared to 2025 for the remainder of the year, reflecting the material price decrease implemented in February 2025. We anticipate that year-over-year comparisons will stabilize once a full year has elapsed following the price reduction, assuming no additional structural price decreases occur in the interim.

Highlights of the sales of our products for the three and six nine months ended June September 30, 2026 and 2025 are provided below. See Note 5 Product and Geographic Information to the Condensed Consolidated Financial Statements for further details on sales of our products.

Three Months Ended June September 30, % Change % Change Excluding Foreign Exchange Six Nine Months Ended June September 30, % Change % Change Excluding Foreign Exchange ($ in millions) 2026 2025 2026 2025

Nexplanon/Implanon NXT $ 200 $ 223 (10) % (11) % $ 631 $ 711 (11) % (13) %

NuvaRing 25 26 (2) (2) 76 75 1 (4)

Marvelon/Mercilon 28 31 (10) (9) 85 103 (17) (18)

Follistim AQ 67 64 6 5 188 206 (9) (11)

Jada 20 (100) (100) 5 54 (90) (90)

Worldwide sales of Nexplanon, a single-rod subdermal contraceptive implant, declined 4% 10% and 12% 11% for the three and six nine months ended June September 30, 2026, compared to 2025, respectively, primarily due to decreased physician demand in the United States following the five-year label approval as reinsertions have been delayed and there has been uncertainty around federal funding. We estimate that expanding use from the new label will begin to favorably offset the reinsertion headwind beginning In the second half of 2026. In 2025, we submitted a similar application for a five-year duration period of use to the EU and UK Health Authorities. The application for five-year duration was approved for the UK in April, 2026. The EU application is currently under review, with potential approval in 2027, subject to health authority review and approval. Outside of the U.S., sales for the nine months ended September 30, 2026 were positively impacted by increased demand and access in Brazil, which we expect to continue for the remainder of 2026.

Worldwide sales of NuvaRing , a vaginal contraceptive product, declined 4% 2% for the three months ended June September 30, 2026, compared to 2025, due to decreased demand in various international markets. partially offset by lower discount rates in the United States. Sales of NuvaRing , increased 2% 1% for the six nine months ended June September 30, 2026, compared to 2025, due to the favorable impact of foreign exchange and lower discount rates in the United States, offset by decreased demand in various international markets.

Worldwide sales of Marvelon (desogestrel and ethinyl estradiol pill) and Mercilon (desogestrel and ethinyl estradiol pill), combined oral hormonal daily contraceptive pills not approved or marketed in the United States, but available in certain countries outside the United States, declined 4% 10% and 20% 17% for the three and six nine months ended June September 30, 2026, compared to 2025, respectively, as a result of decreased demand and market contraction in China. and the timing of shipments in Asia Pacific. In the second quarter of 2026, we received regulatory approval in Japan for Mercilon Combination Tablets, a low-dose estrogen-progestin (LEP) product for the treatment of dysmenorrhea.

Worldwide sales of Follistim AQ , a fertility treatment, increased 6% for the three months ended September 30, 2026, compared to 2025, as a result of increased demand and favorable discount rates in the United States, partially offset by decreased demand in China. Sales of Follistim AQ, declined 9% for the nine months ended September 30, 2026, compared to 2025, as a result of competitive pricing pressures in the United States and decreased demand in China partially offset by increased demand and favorable discount rates in the United States.

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Renflexis $ 65 $ 63 4 % 3 % $ 122 $ 120 2 % 1 %

Hadlima 79 50 59 58 146 96 51 51

Ontruzant 6 31 (81) (81) 11 49 (77) (77)

Brenzys 14 22 (34) (37) 34 36 (5) (10)

Bildyos/Bilprevda 19 * * 35 * *

In January 2026, we completed the sale of the Jada System to Laborie and, thereafter, we were no longer actively selling the sold Jada System. . As a result, worldwide sales of Jada a device intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, significantly declined for the three and six nine months ended June September 30, 2026, compared to 2025, respectively.

Three Months Ended June September 30, % Change % Change Excluding Foreign Exchange Six Nine Months Ended June September 30, % Change % Change Excluding Foreign Exchange ($ in millions) 2026 2025 2026 2025

Renflexis $ 67 $ 70 (5) % (5) % $ 190 $ 190 % (1) %

Hadlima 86 63 35 35 231 159 45 45

Ontruzant 7 31 (77) (77) 18 80 (77) (77)

Brenzys 22 23 (5) (6) 56 59 (5) (8)

Bildyos/Bilprevda 24 3 * * 60 3 * *

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Atozet $ 80 $ 86 (7) % (9) % $ 165 $ 162 1 % (2) %

Zetia/Vytorin 118 101 16 12 226 209 8 3

Cozaar/Hyzaar 50 56 (10) (13) 107 111 (3) (7)

Singulair $ 48 $ 66 (27) % (27) % $ 88 $ 140 (37) % (39) %

Nasonex 58 66 (12) (16) 123 137 (10) (17)

Dulera 41 41 1 76 84 (10) (11)

Renflexis is a biosimilar to Remicade 2 (infliximab) for the treatment of certain autoimmune conditions. Sales increased 4% declined 5% and 2% remained consistent for the three and six nine months ended June September 30, 2026, compared to 2025, respectively, primarily due to increased demand in Canada, partially offset by competitive pressure and unfavorable discount rates in the United States, partially offset by increased demand in Canada.

Hadlima is a biosimilar to Humira 2 (adalimumab) for the treatment of certain autoimmune and autoinflammatory conditions. Sales increased 59% 35% and 51% 45% for the three and six nine months ended June September 30, 2026, compared to 2025, respectively, due to stronger demand in the United States and Puerto Rico. We have commercialization rights to Hadlima in countries outside of the European Union, South Korea, China, Turkey, and Russia. Hadlima is currently approved in the United States, Australia, Canada, and Israel.

Ontruzant is a biosimilar to Herceptin 2 (trastuzumab) for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Sales for the three and six nine months ended June September 30, 2026, compared to 2025, declined 81% and 77%, respectively, due to lower tendered volume from Brazil s Ministry of Health when compared with the same period periods in 2025. We have commercialization rights to Ontruzant in all countries except in South Korea and China.

Brenzys is a biosimilar to Enbrel 2 (etanercept) for the treatment of certain inflammatory diseases. Sales for the three and six nine months ended June September 30, 2026, compared to 2025, declined 34% and 5%, respectively, as a result of the timing of shipments in Brazil and decreased demand in the Asia Pacific region. We have commercialization rights to Brenzys in countries outside of the United States, Europe, South Korea, China, and Japan.

Bildyos injection 60 mg/mL and Bilprevda injection 120 mg/1.7 mL, are biosimilars to Prolia and Xgeva , respectively, for all indications of the reference products . Sales were $19 $24 million and $35 $60 million for the three and six nine months ended June September 30, 2026, respectively, as a result of the product launch in the third quarter of 2025.

International revenue during the period was partially constrained by various supply-related challenges affecting the Company's ability to fully meet customer demand, primarily for certain of our Established Brands products. While some of these challenges surfaced in prior periods, the current period had compounding constraints across the supply chains and resulted in an unfavorable impact estimated to be approximately less than 2% to the Company s consolidated revenue for the three and nine months ended September 30, 2026. These challenges included the impact of manufacturing disruptions at a key contract manufacturer, temporary operational constraints at certain facilities, labor-related disruptions at a third-party logistics provider, and geopolitical disruptions (the Supply Constraints ). Management continues to implement mitigation strategies designed to improve production and supplier reliability, strengthen supply chain resilience, and support future demand. While certain of these challenges have been resolved, full recovery of the supply chains remain on-going.

Three Months Ended June September 30, % Change % Change Excluding Foreign Exchange Six Nine Months Ended June September 30, % Change % Change Excluding Foreign Exchange ($ in millions) 2026 2025 2026 2025

Atozet $ 85 $ 95 (10) % (10) % $ 250 $ 257 (3) % (5) %

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and 61 more changes in the filing

Market risk 1 change

There have been no changes to our market risk during the quarter ended June September 30, 2026. For a discussion of our exposure to market risk, refer to our market risk disclosures set forth under Item 7A. Quantitative and Qualitative Disclosures About Market Risk in our Annual Report on Form 10-K for the year ended December 31, 2025.

Controls and procedures 26 changes

Quarterly Evaluation of Disclosure Controls and Procedures

Our management, with the participation of the CEO and the CFO, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2026 in connection with the filing of this report. Based on this evaluation, the CEO and the CFO concluded that our disclosure controls and procedures were effective as of June 30, 2026 at the reasonable assurance level.

Remediation of Material Weaknesses in Internal Control Over Financial Reporting

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.

As disclosed in the Company s Annual Report on Form 10-K for the year ended December 31, 2025, we previously identified the following material weaknesses in our internal control over financial reporting.

We failed to set an appropriate tone at the top. Specifically, our former CEO and leader of our U.S. commercial organization applied inappropriate pressure to achieve sales targets through sales of Nexplanon to two United States wholesalers above demand and engaged in inappropriate business conduct that violated our Code of Conduct.

The material weakness with respect to our tone at the top contributed to an additional material weakness of not maintaining effective controls related to information and communication. We did not design and maintain effective controls related to the information and communication component of the framework in Internal Control Integrated Framework issued in 2013 by the Committee of Sponsoring Organizations of the Treadway Commission. Specifically, our former CEO and certain senior members of our U.S. commercial organization did not ensure appropriate communication with, or provide complete information to, our Disclosure Committee and the financial reporting group to evaluate disclosures and financial reporting conclusions related to sales practices for wholesalers.

These material weaknesses did not result in misstatements of our previously reported historical financial statements. Each of these material weaknesses could have resulted in a misstatement of substantially all account balances or disclosures that could have resulted in a material misstatement to our annual or interim consolidated financial statements that would not have been prevented or detected.

During 2026, management executed upon its previously disclosed remediation plan to address the material weaknesses described above. We devoted substantial resources towards the implementation of enhanced procedures and controls and the remediation of material weaknesses in our internal control over financial reporting. We established a Remediation Plan Task Force to serve as a Project Management Office to monitor our remediation efforts and have also engaged external legal, accounting, financial and other consulting and professional services firms to assist in the development and execution of our comprehensive remediation plan. Actions taken include:

On October 27, 2025, our Board of Directors enacted Company leadership changes with the executive appointments of Joseph Morrissey as our Interim CEO and Carrie S. Cox as our Interim Executive Chair, with Mr. Morrissey and Ms. Cox being appointed to such roles on a permanent basis on April 26, 2026.

On October 27, 2025, Michael Casia was appointed as Interim Head of US Commercial and Government Affairs, with Mr. Casia being appointed to this role on a permanent basis on May 6, 2026.

Beginning in November 2025, we held multiple Founders meetings with employees, including Global Founders Forums and U.S. Commercial Town Hall. Senior leadership disseminated Company-wide and team-specific communications to emphasize our commitment to our core values, compliance, integrity and ethics.

On December 2, 2025, our Board of Directors ratified our enhanced Code of Conduct to clarify responsibilities related to our financial reporting and disclosures, including awareness of the options to raise concerns or questions to our management, human resources, compliance, legal, the technical accounting department and/or through the SpeakUp Tool, which is available globally as an alternate, confidential channel for raising concerns.

On January 30, 2026, we communicated and launched training on our Code of Conduct, as amended, regarding ethical tone, corporate culture and appropriate business practices.

During the quarter ended December 31, 2025, we implemented revisions to our Quarterly Financial Certification Questionnaire to include targeted questions that are designed to (i) address areas tied to the material weaknesses we identified in our internal control over financial reporting, (ii) strengthen our disclosures and (iii) reduce the risk of misleading business practices.

On February 2, 2026, our Audit Committee ratified an enhanced Disclosure Committee charter that was previously approved by our Interim CEO and CFO. These changes to the Disclosure Committee charter included, among other changes, (i) enumerating additional Disclosure Committee meeting requirements and guidelines for Disclosure Committee members and participants, (ii) providing for a Disclosure Committee Chair designated by the CEO and CFO, (iii) expanding the duties and responsibilities of the Disclosure Committee as to the type and scope of disclosure and risks for its review, (iv) requiring the Disclosure Committee to annually review its charter to identify any recommend changes and (v) mandating continuing education and training of the participants in our disclosure process. In addition, we strengthened our Disclosure Committee processes and procedures to facilitate active participation by Disclosure Committee members.

During the quarter ended December 31, 2025, we implemented additional and enhanced Sarbanes-Oxley ( SOX ) sub-certifications and internal management representation letters to support our public reporting and disclosure. By January 15, 2026, we provided training to our Executive Leadership Team and to other Disclosure Committee members and participants on the purpose and importance of SOX, SOX sub-certifications and the process for evaluating the representations made that support the disclosure contained in our filings.

On February 25, 2026, an enhancement to the Company s Annual Ethics and Policy Certification was launched to all of our employees, requiring all founders to review and certify their understanding of ethical responsibilities and compliance with laws, regulations, and Organon policies, including our Code of Conduct.

On March 31, 2026, we communicated and launched training to relevant commercial and finance employees on revenue-related business practices, emphasizing the importance of revenue recognition and related disclosures. This training reinforced our commitment to ethical conduct, transparency, accuracy and reliability and helped to strengthen credibility and trust in our financial reporting.

We performed a comprehensive review of the quarterly Distribution Services Agreement payment process. Based on that review, we developed an internal policy to provide oversight and establish guidelines for management fee arrangements with wholesalers. This policy and related procedures were communicated to relevant U.S. Commercial employees on April 24, 2026.

New internal controls were implemented effective Q1 2026 related to US sales monitoring, as well as enhanced reviews for inventory levels at the wholesaler and days on hand at the wholesaler.

Our management completed testing of the implemented remediation actions described above during the quarter ended June 30, 2026, and found them to be operating effectively. As a result, management has concluded that the material weaknesses in internal control over financial reporting have been remediated as of June 30, 2026.

Quarterly Changes in Internal Control Over Financial Reporting

There was no change in our internal control over financial reporting that occurred during the three months ended June 30, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

We have established disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Exchange Act) to provide reasonable assurance that information required to be disclosed in the reports we file or submit under the Exchange Act is accumulated and communicated to Our management, including with the participation of our Chief Executive Officer ( CEO ) (our principal executive officer) and Chief Financial Officer ( CFO ) (our principal financial officer), evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as appropriate to allow timely decisions regarding required defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act of 1934, as amended (the Exchange Act )) as of September 30, 2026. Based upon that evaluation, our CEO and our CFO concluded that, as of September 30, 2026, the end of the period covered by this report, our disclosure controls and ensure procedures were effective and provide reasonable assurance that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC s applicable rules and forms, and that it is accumulated and communicated to our management, including our CEO and our CFO, as appropriate, to allow timely decisions regarding required disclosure.

During the quarter ended September 30, 2026, there were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Other information 1 change

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During the three months ended June September 30, 2026, none of our directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement, as each term is defined in Item 408(a) of Regulation S-K.

Exhibits 9 changes

2.1 Agreement and Plan of Merger, dated as of April 26, 2026, by and among Organon & Co., Sun Pharmaceutical Holdings USA, Inc., Sun Pharma America, Inc. and, solely for the purposes of certain Covered Provisions of the Merger Agreement (as defined therein), Sun Pharmaceutical Industries Limited, Sun Pharma Canada Inc. and Sun Pharma (Netherlands) B.V. (incorporated by reference to Exhibit 2.1 to the Company s Current Report on Form 8-K filed on April 27, 2026).

* 10.2 Amendment No. 9 to Development and Commercialization Agreement, dated May 26, 2026, by and between Samsung Bioepsis Co. Ltd. and Organon LLC.

* 10.3 Amendment No. 10 to Development and Commercialization Agreement, dated June 2, 2026, by and between Samsung Bioepsis Co., Ltd. and Organon LLC.

+10.4 Amended and Restated Organon & Co. 2021 Incentive Stock Plan (incorporated by reference to the Company s Definitive Proxy Statement on Schedule 14A filed on April 24, 2026).

* 10.1 Amendment No. 8 11 to the Development and Commercialization Agreement, dated May 22, September 11, 2026, by and between Samsung Bioepsis Bioepis Co., Ltd. and Organon LLC.

*+10.2 Organon Executive Change in Control Severance Program, as amended and restated on April 15, 2025, as further amended on August 14 , 2026.

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Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Date: October 30, 2026

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Date: October 30, 2026

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