SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_____________________


☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

(Registrant’s telephone number, including area code) (551) 430-6900


			Not Applicable
(Former name, former address and former fiscal year, if changed since last report.)


Securities registered pursuant to Section 12(b) of the Act:
Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock ($0.01 par value)	OGN	New York Stock Exchange

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act. (Check one):


Large accelerated filer	☒	Accelerated filer	☐

Non-accelerated filer	☐	Smaller reporting company	☐

		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The number of shares of common stock outstanding as of the close of business on ~~April 28,~~October 27, 2023: ~~255,061,747~~255,606,461

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements

Condensed Consolidated Statements of Income

(Unaudited, $ in millions except shares in thousands and per share amounts)


		Three Months Ended March 31,			Three Months Ended September 30,				Nine Months Ended September 30,
			2023			2022			2023		2022		2023		2022
Revenues	Revenues		$	1,538		$	1,567	Revenues	$	1,519	$	1,537	$	4,665	$	4,689
Costs, Expenses and Other	Costs, Expenses and Other							Costs, Expenses and Other
Cost of sales	Cost of sales		580			561		Cost of sales	612		551		1,832		1,700
Selling, general and administrative	Selling, general and administrative		435			371		Selling, general and administrative	538		440		1,424		1,234
Research and development	Research and development		129			96		Research and development	137		127		394		329
Acquired in-process research and development and milestones	Acquired in-process research and development and milestones		8			—		Acquired in-process research and development and milestones	—		10		8		107
Restructuring costs	Restructuring costs		4			—		Restructuring costs	—		11		4		11
Interest expense	Interest expense		132			97		Interest expense	134		108		398		303
Exchange losses (gains)	Exchange losses (gains)		9			(4)		Exchange losses (gains)	14		4		25		(21)
Other expense, net	Other expense, net		6			4		Other expense, net	4		4		11		15
			1,303			1,125			1,439		1,255		4,096		3,678
Income From Operations Before Income Taxes			235			442
Taxes on Income			58			94
Income Before Income Taxes								Income Before Income Taxes	80		282		569		1,011
Taxes on income								Taxes on income	22		55		92		202

Net Income	Net Income		$	177		$	348	Net Income	$	58	$	227	$	477	$	809

Earnings per Share:	Earnings per Share:							Earnings per Share:

Basic	Basic		$	0.70		$	1.37	Basic	$	0.23	$	0.89	$	1.87	$	3.19

Diluted	Diluted		$	0.69		$	1.36	Diluted	$	0.23	$	0.89	$	1.86	$	3.17

Weighted Average Shares Outstanding:	Weighted Average Shares Outstanding:							Weighted Average Shares Outstanding:
Basic	Basic		254,392			253,583		Basic	255,588		254,348		255,112		253,986
Diluted	Diluted		256,170			255,052		Diluted	256,349		255,067		256,162		255,094

The accompanying notes are an integral part of these interim Condensed Consolidated Financial Statements.

Condensed Consolidated Statements of Comprehensive Income

(Unaudited, $ in millions)

Three Months Ended
March 31,
2023 2022
Net Income $ 177 $ 348
Other Comprehensive Income (Loss), Net of Taxes:
Benefit plan net loss and prior service credit, net of amortization — (1)
Cumulative translation adjustment 30 (15)
30 (16)
Comprehensive Income $ 207 $ 332


	Three Months Ended September 30,				Nine Months Ended September 30,
	2023		2022		2023		2022
Net income	$	58	$	227	$	477	$	809
Other Comprehensive Income, Net of Taxes:
Benefit plan net loss and prior service cost, net of amortization	—		—		(1)		—
Cumulative translation adjustment	(43)		(97)		(11)		(173)
	(43)		(97)		(12)		(173)
Comprehensive income	$	15	$	130	$	465	$	636

The accompanying notes are an integral part of these interim Condensed Consolidated Financial Statements.

Condensed Consolidated Balance Sheets

(Unaudited, $ in millions except shares in thousands and per share amounts)

Accounts receivable (net of allowance for doubtful accounts of $9 in

2023 and $9 in 2022)

Accounts receivable (net of allowance for doubtful accounts of $9 in

2023 and $9 in 2022)

Accounts receivable (net of allowance for doubtful accounts of $9 in

2023 and $9 in 2022)

Common stock, $0.01 par value

Authorized - 500,000

Issued and outstanding - 254,432 in 2023 and 254,370 in 2022

Common stock, $0.01 par value

Authorized - 500,000

Issued and outstanding - 255,606 in 2023 and 254,370 in 2022

Common stock, $0.01 par value

Authorized - 500,000

Issued and outstanding - 255,606 in 2023 and 254,370 in 2022

The accompanying notes are an integral part of these interim Condensed Consolidated Financial Statements.

Condensed Consolidated Statements of Stockholders' Equity (Deficit)

(Unaudited, $ in millions, except shares in thousands and per share amounts)

The accompanying notes are an integral part of these interim Condensed Consolidated Financial Statements.

Condensed Consolidated Statements of Cash Flows

(Unaudited, $ in millions)


		Three Months Ended March 31,				Nine Months Ended September 30,
		2023		2022				2023		2022
Cash Flows from Operating Activities	Cash Flows from Operating Activities						Cash Flows from Operating Activities
Net income	Net income	$	177	$	348		Net income	$	477	$	809
Adjustments to reconcile net income to net cash flows provided by operating activities:	Adjustments to reconcile net income to net cash flows provided by operating activities:						Adjustments to reconcile net income to net cash flows provided by operating activities:
Depreciation	Depreciation	28		25			Depreciation	88		72
Amortization	Amortization	29		28			Amortization	88		88

Impairment of assets							Impairment of assets	—		9
Acquired in-process research and development and milestones	Acquired in-process research and development and milestones	8		—			Acquired in-process research and development and milestones	8		107
Deferred income taxes	Deferred income taxes	3		(4)			Deferred income taxes	4		(18)
Stock-based compensation	Stock-based compensation	22		15			Stock-based compensation	74		52
Unrealized foreign exchange loss (gain)	Unrealized foreign exchange loss (gain)	2		(6)			Unrealized foreign exchange loss (gain)	19		(45)
Other	Other	8		6			Other	24		24
Net changes in assets and liabilities	Net changes in assets and liabilities						Net changes in assets and liabilities
Accounts receivable	Accounts receivable	39		54			Accounts receivable	(185)		(119)
Inventories	Inventories	(38)		14			Inventories	(137)		(134)
Other current assets	Other current assets	(3)		(37)			Other current assets	(56)		(76)
Trade accounts payable	Trade accounts payable	(139)		(298)			Trade accounts payable	(68)		(323)
Accrued and other current liabilities	Accrued and other current liabilities	(47)		(45)			Accrued and other current liabilities	34		108

Income taxes payable	Income taxes payable	6		30			Income taxes payable	(21)		45
Other	Other	19		(7)			Other	53		(8)
Net Cash Flows Provided by Operating Activities	Net Cash Flows Provided by Operating Activities	114		123			Net Cash Flows Provided by Operating Activities	402		591
Cash Flows from Investing Activities	Cash Flows from Investing Activities						Cash Flows from Investing Activities
Capital expenditures	Capital expenditures	(46)		(33)			Capital expenditures	(172)		(133)

Proceeds from sale of property, plant and equipment							Proceeds from sale of property, plant and equipment	1		3
Acquired in-process research and development and milestones	Acquired in-process research and development and milestones	(8)		—			Acquired in-process research and development and milestones	(8)		(105)
Purchase of product rights and asset acquisition, net of cash acquired	Purchase of product rights and asset acquisition, net of cash acquired	—		(30)			Purchase of product rights and asset acquisition, net of cash acquired	—		(124)
Net Cash Flows Used in Investing Activities	Net Cash Flows Used in Investing Activities	(54)		(63)			Net Cash Flows Used in Investing Activities	(179)		(359)
Cash Flows from Financing Activities	Cash Flows from Financing Activities						Cash Flows from Financing Activities

Proceeds from debt							Proceeds from debt	80		—
Repayments of debt	Repayments of debt	(252)		(2)			Repayments of debt	(336)		(106)

Net transfers to Merck & Co., Inc.	Net transfers to Merck & Co., Inc.	—		(18)			Net transfers to Merck & Co., Inc.	—		(17)
Employee withholding taxes related to stock-based awards	Employee withholding taxes related to stock-based awards	(1)		—			Employee withholding taxes related to stock-based awards	(15)		(11)
Dividend payments	Dividend payments	(73)		(71)			Dividend payments	(221)		(217)
Net Cash Flows Used in Financing Activities	Net Cash Flows Used in Financing Activities	(326)		(91)			Net Cash Flows Used in Financing Activities	(492)		(351)
Effect of Exchange Rate Changes on Cash and Cash Equivalents	Effect of Exchange Rate Changes on Cash and Cash Equivalents	19		(12)			Effect of Exchange Rate Changes on Cash and Cash Equivalents	(23)		(119)
Net Decrease in Cash and Cash Equivalents	Net Decrease in Cash and Cash Equivalents	(247)		(43)			Net Decrease in Cash and Cash Equivalents	(292)		(238)
Cash and Cash Equivalents, Beginning of Period	Cash and Cash Equivalents, Beginning of Period	706		737			Cash and Cash Equivalents, Beginning of Period	706		737
Cash and Cash Equivalents, End of Period	Cash and Cash Equivalents, End of Period	$	459	$	694		Cash and Cash Equivalents, End of Period	$	414	$	499

The accompanying notes are an integral part of these interim Condensed Consolidated Financial Statements.

Table of Contents

Notes to Condensed Consolidated Financial Statements (unaudited)

1. Background and Nature of Operations

Organon & Co. ("Organon" or the "Company") is a global health care company with a focus on improving the health of women throughout their lives. Organon develops and delivers innovative health solutions through a portfolio of prescription therapies and medical devices within women's health, biosimilars and established brands (the "Organon Products"). Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. The Company sells these products through various channels including drug wholesalers and retailers, hospitals, government agencies and managed health care providers such as health maintenance organizations, pharmacy benefit managers and other institutions. The Company operates 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, the Organon group of companies.

The Company's operations include the following product portfolios:

•Women's Health: Organon's women's health products are 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, which is a class of contraceptives that is recognized as one of the most effective types of hormonal contraception available to patients with a low long-term average cost. Other women’s health products include the Jada® System, which is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted and a license from Daré Biosciences for the global commercial rights to Xaciato™ (clindamycin phosphate vaginal gel, 2%), an FDA-approved medication for the treatment of bacterial vaginosis ("BV") in females 12 years of age and older. In October 2023, Xaciato was launched in the United States.

•Biosimilars: Organon's current portfolio spans across immunology and oncology treatments. Organon's oncology biosimilars have been launched in more than 20 countries and Organon's immunology biosimilars have been launched in five countries. All five biosimilars in Organon's portfolio have launched in Canada, and ~~two~~three biosimilars; Ontruzant® (trastuzumab-dttb)~~and~~, Renflexis® (infliximab-abda) and Hadlima™ (adalimumab-bwwd) have been launched in the United States.

•Established Brands: Organon has a portfolio of established brands, which generally are beyond market exclusivity, including leading brands in cardiovascular, respiratory, dermatology and non-opioid pain management. A number of Organon's established brands lost exclusivity years ago and have faced generic competition for some time.

2. Basis of Presentation

The accompanying unaudited financial statements have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”) and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, certain information and disclosures required by GAAP for complete consolidated financial statements are not included herein. The results of operations of any interim period are not necessarily indicative of the results of operations for the full year. In the Company's opinion, all adjustments necessary for a fair statement of these interim statements have been included and are of a normal and recurring nature. All intercompany transactions and accounts within Organon have been eliminated. These interim statements should be read in conjunction with the audited financial statements and notes thereto included in Organon's Annual Report on Form 10-K for the year ended December 31, 2022.

The presentation of these Condensed Consolidated Financial Statements and accompanying notes in conformity with U.S. GAAP require management to make estimates and assumptions that affect the amounts reported, as further described in ~~our~~the Annual Report on Form 10-K for the year ended December 31, 2022. Accordingly, actual results could differ materially from management's estimates and assumptions.

The Company ~~continues to experience uncertainty relative to~~was impacted by COVID-19 during the ~~duration and overall impact~~first half of ~~COVID-19,~~2023, specifically, in the Company's operations in China. The ~~future operating performance in that region, particularly in the short-term, may be subject to volatility.~~Company does not anticipate a continued impact from COVID-19. The assessment of certain accounting matters and specifically its effect on the Company's results require consideration of forecasted financial information in the context of the information reasonably available to the Company and the future impacts of COVID-19 on the Company's operations in China as of March 31, 2023 and through the date of this report which are difficult to predict.

Table of Contents

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

information reasonably available to the Company as of September 30, 2023 and through the date of this report which are difficult to predict.

Recently Adopted Accounting Standards

In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting, optional guidance to ease the potential burden in accounting for (or recognizing the effects of) reference rate reform on financial reporting and subsequently issued clarifying amendments. The guidance provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions that reference the London Interbank Offered Rate ("LIBOR") or another reference rate expected to be discontinued because of reference rate reform. The optional guidance is effective upon issuance and can be applied on a prospective basis at any time between January 1, 2020 and December 31, 2022; the sunset date was subsequently deferred to December 31, 2024 based on the amendment issued in December 2022 under ASU 2022-06, Reference Rate Reform (Topic 848). The Company applied this guidance to our Senior Credit Agreement, as amended on June 30, 2023. The impact to the Consolidated Financial Statements as a result of the application of the reference rate reform guidance is not material. See Note 11 "Long-Term Debt" for additional details.

In October 2021, the FASB issued ASU 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers, guidance to improve the accounting for contract assets and contract liabilities from acquired revenue contracts with customers in a business combination. The guidance addresses diversity in practice and inconsistency related to the recognition of an acquired contract liability, payment terms and their effect on subsequent revenue recognized by an acquirer. The guidance became effective for the Company on January 1, 2023 and its amendments will be applied prospectively to business combinations occurring on or after the effective date of the guidance. The adoption of this guidance did not have an impact on the Company's Consolidated Financial Statements for prior acquisitions; however, the impact in future periods will be dependent upon the contract assets and contract liabilities acquired in future business combinations.

~~Recently Issued Accounting Standards Not Yet Adopted~~

~~The following summarizes recent Accounting Standards Updates ("ASUs") issued by the FASB that could have a material impact on our consolidated financial statements.~~

~~In March 2020, the FASB issued ASU 2020-04,~~ ~~Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting~~, optional guidance to ease the potential burden in accounting for (or recognizing the effects of) reference rate reform on financial reporting and subsequently issued clarifying amendments. The guidance provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions that reference the London Interbank Offered Rate ("LIBOR") or another reference rate expected to be discontinued because of reference rate reform. The optional guidance is effective upon issuance and can be applied on a prospective basis at any time between January 1, 2020 and December 31, 2022, the sunset date was subsequently deferred to December 31, 2024 based on the amendment issued in December 2022 under ASU 2022-06, ~~Reference Rate Reform (Topic 848)~~. The Company is still evaluating the impact to its LIBOR-based debt. Based on the evaluation thus far, the Company does not anticipate a material impact to the Consolidated Financial Statements as a result of reference rate reform.

3. Acquisitions and Licensing Arrangements

Claria Medical, Inc. ("Claria")

In January 2023, the Company made a strategic investment in Claria, a privately-held company developing an investigational medical device being studied for use during minimally invasive laparoscopic hysterectomy. Under the terms of the agreement, Organon paid $8 million upfront and has the option to acquire Claria for an additional $47 million, payable if and when the option is exercised. The $8 million was expensed as Acquired in-process research and development and milestones in our Condensed Consolidated Statement of Income for the ~~three~~nine months ended ~~March 31,~~September 30, 2023.

~~Table of Contents~~

~~Notes to Condensed Consolidated Financial Statements (unaudited)~~ ~~(continued)~~

4. Earnings per Share ("EPS")

The calculations of basic and diluted earnings per common share are as follows:

Diluted EPS iswas computed ~~by giving effect to all potentially dilutive~~using the treasury stock method for stock option awards, ~~that are outstanding.~~performance share units and restricted share units. The computation of diluted EPS excludes the effect of the potential exercise of stock-based awards when the effect of the potential exercise would be anti-dilutive.

Table of Contents

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

5. Product and Geographic Information

The Company's operations include the following product portfolios, which constitute one operating segment engaged in developing and delivering innovative health solutions through its portfolio of prescription therapies within women's health, biosimilars and established brands.

Revenues of the Company's products were as follows:

Other Women's Health (1)

Other Cardiovascular (1)

Other Respiratory (1)

Other Non-Opioid Pain, Bone and Dermatology (1)

Totals may not foot due to rounding. Trademarks appearing above in italics are trademarks of, or are used under license by, the Organon group of companies.

(1) Includes sales of products not listed separately. Revenues from ~~Marvelon/~~Marvelon and Mercilon and Jada were previously reported as part of Other Women's Health. Revenue from an arrangement for the sale of generic etonogestrel/ethinyl estradiol vaginal ring is included in Other Women's Health.

(2) Includes manufacturing sales to Merck & Co., Inc. ("Merck") and third parties for current and prior periods.

Table of Contents

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Revenues by geographic area where derived are as follows:

(1) Primarily reflects manufacturing sales to Merck and third parties for current and prior periods.

6. Stock-Based Compensation Plans

The Company grants stock option awards, performance share units ("PSUs") and restricted share units ("RSUs") pursuant to its 2021 Incentive Stock Plan.

Employee stock options are granted to purchase shares of Company stock at the fair market value at the time of grant. Generally, stock options have a contractual term of ten years and vest one-third each year over a three-year period, subject to limited exceptions.

~~RSUs are stock awards that are granted to employees and entitle the holder to shares of common stock as the awards vest. RSU awards generally vest one-third each year over a three-year period.~~ The ~~fair value of the stock option and RSU awards is determined and fixed on the grant date based on the Company's stock price.~~

~~The terms of the Company's~~ PSU awards ~~allow the recipients of such awards to earn a variable number of common shares based on the cumulative results of specified performance factors. The Company has PSU awards~~are based on the following performance factors:

•total stockholder return of the Company relative to an index of peer companies ("relative TSR") specified in the ~~awards~~awards; and

•the results of the cumulative free cash flow ("FCF") of the Company over a ~~three year period~~three-year period.

~~For FCF and relative TSR awards,~~Stock-based compensation expenses incurred by the Company ~~recognizes compensation costs ratably over the performance period.~~ were as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
($ in millions)	2023		2022		2023		2022
Stock-based compensation expense recognized in:
Cost of sales	$	5	$	3	$	13	$	9
Selling, general and administrative	18		12		50		35
Research and development	4		3		11		8
Total	$	27	$	18	$	74	$	52

Income tax benefits	$	6	$	3	$	16	$	11

The PSU awards will generally vest at the end of the three year performance period, however, the number of shares delivered will vary based upon the attained level of performance. For PSUs with a performance-based FCF goal, stock-based compensation expense is recognized based on the probability of the achievement of the financial performance metric for the respective vesting period and is assessed at each reporting date. For PSUs with a market-based relative TSR goal, stock-based compensation expense is recognized based on the estimatedweighted average fair value of options granted was determined using the ~~award at the grant date regardless of the actual number of shares earned. PSU awards generally vest after three years.~~following assumptions:

For RSUs and PSUs, dividends declared during the vesting period are payable to the employees only upon vesting. RSU and PSU distributions will be in shares of Company stock after the end of the vesting or performance period, subject to the terms applicable to such awards.


	Nine Months Ended September 30,
	2023		2022
Expected dividend yield	4.82	%	3.12	%
Risk-free interest rate	3.56		2.47
Expected volatility	42.30		43.43
Expected life (years)	5.89		5.89

Table of Contents

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

~~Stock-based compensation expenses incurred by the Company were as follows:~~

Three Months Ended
March 31,
($ in millions) 2023 2022
Stock-based compensation expense recognized in:
Cost of sales $ 4 $ 3
Selling, general and administrative 15 10
Research and development 3 2
Total $ 22 $ 15
Income tax benefits $ 5 $ 3

~~The weighted average fair value of options was determined using the following assumptions:~~

Three Months Ended
March 31,
2023 2022
Expected dividend yield 4.82 % 3.12 %
Risk-free interest rate 3.56 2.47
Expected volatility 42.30 43.43
Expected life (years) 5.89 5.89

A summary of the equity award transactions for the ~~three~~nine months ended ~~March 31,~~September 30, 2023 ~~are~~is as follows:

The following table summarizes information about equity awards outstanding that are vested and expected to vest and equity awards outstanding that are exercisable as of ~~March 31,~~September 30, 2023:

The amount of unrecognized compensation costs as of ~~March 31,~~September 30, 2023 was ~~$211~~$170 million, which will be recognized in operating expense ratably over the weighted average vesting period of ~~2.28~~1.93 years.

~~Table of Contents~~

~~Notes to Condensed Consolidated Financial Statements (unaudited)~~ ~~(continued)~~

In 2022, Organon initiated restructuring activities to optimize its internal operations by reducing headcount through selected markets and functions. As a result of this program, the Company ~~intends to restructure~~restructured approximately 130 positions, with the majority of the position eliminations occurring in selected markets outside of the ~~U.S.~~United States in our commercial organizations. During the ~~three~~nine months ended ~~March 31,~~September 30, 2023, $5$15 million of restructuring charges have been paid, with the ~~majority of the~~remaining severance payments ~~expected~~ to be paid by the end of the 2023 fiscal year. For the ~~three~~nine months ended ~~March 31,~~September 30, 2023, the Company recorded restructuring charges of $4 million, which relate to severance costs for eliminated positions.

Liabilities for costs associated with restructuring activities were ~~$19~~$10 million and $20 million at ~~March 31,~~September 30, 2023 and December 31, 2022, respectively, and are included primarily in Accrued and other current liabilities.

In the fourth quarter of 2023, Organon will implement additional restructuring activities to optimize its internal operations by reducing headcount in certain markets and functions. As a result of these activities, the Company expects to restructure approximately 3% of the Company's headcount, which is expected to result in a charge of approximately $60 million to $70 million primarily representing severance and severance related costs in the fourth of quarter of 2023. These amounts will be paid over the next twelve months.

The effective income tax rates were ~~24.6%~~27.0% and ~~21.3%~~19.6% for the three months ended ~~March 31,~~September 30, 2023 and 2022, respectively, and 16.1% and 20.0% for the nine months ended September 30, 2023 and 2022, 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 partial valuation allowance recorded against non-deductible USU.S. interest expense. The 2023 year-to-date effective tax rate favorable impact is primarily attributable to a reduced tax rate arrangement that was agreed to in Switzerland for an active entity.

Table of Contents

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

On August 16, 2022, the ~~U.S.~~United States enacted the Inflation Reduction Act of 2022. Provisions of the bill that relate to tax include the minimum tax on book income, a 1% excise tax on stock buybacks and certain tax incentives to promote clean energy. There are no impacts of the legislation to the ~~first~~third quarter 2023 results. The Company will continue to assess future impacts of this legislation.

Inventories consisted of:

Amounts recognized as Other assets are comprised primarily of raw materials and work in process inventories and are not expected to be converted to finished goods that will be sold within one year. The Company has a long-term vendor supply contract that includes certain annual minimum purchase commitments.

10. Financial Instruments

Foreign Currency Risk Management

The Company has a balance sheet risk management and a net investment hedging program to mitigate against volatility of changes in foreign exchange rates.

The Company uses a balance sheet risk management program to partially mitigate the exposure of net monetary assets of its subsidiaries that are denominated in a currency other than a subsidiary's functional currency from the effects of volatility in

~~Table of Contents~~

~~Notes to Condensed Consolidated Financial Statements (unaudited)~~ ~~(continued)~~

foreign exchange. In these instances, Organon principally utilizes forward exchange contracts to partially offset the effects of exchange on exposures denominated in developed country currencies, primarily the euro, Swiss franc, and Japanese yen. For exposures in developing country currencies, the Company enters into forward contracts to partially offset the effects of exchange on exposures when it is deemed economical to do so based on a cost-benefit analysis that considers the magnitude of the exposure, the volatility of the exchange rate and the cost of the hedging instrument.

Monetary assets and liabilities denominated in a currency other than the functional currency of a given subsidiary are remeasured at spot rates in effect on the balance sheet date with the effects of changes in spot rates reported in Exchange losses (gains). The forward contracts are not designated as hedges and are marked to market through Exchange losses (gains). Accordingly, fair value changes in the forward contracts help mitigate the changes in the value of the remeasured assets and liabilities attributable to changes in foreign currency exchange rates, except to the extent of the spot-forward differences. These differences are not significant due to the short-term nature of the contracts, which typically have average maturities at inception of less than one year. The notional amount of forward contracts was $1.0 billion and $1.5 billion as of ~~March 31,~~September 30, 2023 and December 31, 2022, respectively. The cash flows and the related gains and losses from these contracts are reported as operating activities in the Condensed Consolidated Statements of Cash Flows.

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Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

The Company measures fair value based on the prices that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers ~~include:~~include Level 1, defined as observable inputs such as quoted prices in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs for which little or no market data exists, therefore requiring an entity to develop its own assumptions.

The following financial instruments were recorded at their estimated fair value. The recurring fair value measurement of our assets and liabilities were as follows:

Forward contracts in Other current assets

Forward contracts in Accrued and other current liabilities

Foreign exchange risk is also managed through the use of economic hedges on foreign currency balances. See Note 11 ~~"Long- Term~~"Long-Term Debt" for additional details. ~~€1.987~~€1.983 billion in the aggregate of both the euro-denominated term loan (€~~737~~733 million) and the 2.875% euro-denominated secured notes (€1.25 billion) has been designated and is effective as an economic hedge of the net investment in euro-denominated subsidiaries.

Foreign currency ~~(losses)~~ gains due to spot rate fluctuations on the euro-denominated debt instruments included in foreign currency translation adjustments resulting from hedge designation were as follows:

Foreign currency (losses) gains in Other comprehensive income

Foreign currency gains in Other comprehensive income

The Condensed Consolidated Statements of Income include the impact of actual net (gains) and losses of Organon's derivative financial instruments:

Foreign exchange loss (gain) in Exchange losses (gains)

Organon has established accounts receivable factoring agreements with financial institutions in certain countries to sell accounts receivable. Under these agreements, Organon factored ~~$68~~$55 million and $43 million of accounts receivable as of ~~March 31,~~September 30, 2023 and December 31, 2022, respectively, which reduced outstanding accounts receivable. The cash received from the financial institutions is reported within operating activities in the Condensed Consolidated Statements of Cash Flows.

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Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

11. ~~Long- Term~~Long-Term Debt

The following is a summary of Organon's total debt:

SOFR plus 300 bps plus SOFR adjustment1 term loan due 2028

1.The SOFR adjustment is an additional interest amount per annum of 11.448 bps for a one-month interest period, 26.161 bps for a three-month interest period, or 42.826 bps for a six-month interest period, at our option.

The nature and terms of our ~~Term Loan B Facility,~~Senior Credit Agreement, Notes and Other borrowings are described in detail in Note 11 "Long-Term Debt and Leases" in ~~our~~the 2022 Annual Report on Form ~~10-K.~~10-K for the year ended December 31, 2022.

On June 30, 2023, the Company entered into Amendment No. 1 to the Senior Credit Agreement. Amendment No. 1 replaces LIBOR-based rates with Adjusted Term Secured Overnight Financing Rate ("SOFR")-based rates and updates certain other provisions of the Senior Credit Agreement to reflect the transition from LIBOR to the Adjusted Term SOFR. The impact of the rate transition was not material to the Condensed Consolidated Financial Statements.

Long-term debt was recorded at the carrying amount. The estimated fair value of long-term debt (including current portion) is as follows:

Fair value was estimated using inputs other than quoted prices in active markets for identical assets and liabilities that are observable either directly or indirectly for substantially the full term of the asset or liability and would be considered Level 2 in the fair value hierarchy.

The Company made interest payments related to its debt instruments of ~~$65~~$311 million for the ~~three~~nine months ended ~~March 31,~~September 30, 2023. The average maturity of the Company's long-term debt as of ~~March 31,~~September 30, 2023 is approximately ~~5.7~~5.3 years and the weighted-average interest rate on total borrowings as of ~~March 31,~~September 30, 2023 is ~~5.4%~~5.7%.

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Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

On March 30, 2023, the Company made a discretionary prepayment of $250 million on the U.S. Dollar-denominated term loan.

On June 21, 2023, the Company borrowed $80 million on the Revolving Credit Facility and subsequently repaid the amount on June 30, 2023.

The schedule of principal payments required on long-term debt for the next five years and thereafter is as follows:

The Senior Credit Agreement contains customary financial covenants, including a total leverage ratio covenant, which measures the ratio of (i) consolidated total debt to (ii) consolidated earnings before interest, taxes, depreciation, and amortization, and subject to other adjustments, that must meet certain defined limits which are tested on a quarterly basis. In addition, the Senior Credit Agreement contains covenants that limit, among other things, Organon’s ability to prepay, redeem or repurchase its subordinated and junior lien debt, incur additional debt, make acquisitions, merge with other entities, pay dividends or distributions, redeem, or repurchase equity interests, and create or become subject to liens. As of September 30, 2023, the Company is in compliance with all financial covenants and no default or event of default has occurred.

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Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

12. Accumulated Other Comprehensive Income (Loss)

Changes in Accumulated other comprehensive income (loss) by component are as follows:

13. Samsung Collaboration

The Company has an agreement with Samsung Bioepis Co., Ltd. ("Samsung Bioepis") to develop and commercialize multiple pre-specified biosimilar candidates, which have since launched and are part of the Company's product portfolio. Under the agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and registration of product candidates, and the Company has an exclusive license for worldwide commercialization with certain geographic exceptions specified on a product-by-product basis. The Company's access rights to each product under the agreement last for 10 years from each product's launch date on a market-by-market basis. Gross profits are shared equally in all markets with the exception of certain markets in Brazil where gross profits are shared 65% to Samsung Bioepis and 35% to the Company. Since the Company is the principal on sales transactions with third parties, the Company recognizes sales, cost of sales and selling, general and administrative expenses on a gross basis. Generally, profit sharing adjustments are recorded either to Cost of sales (after commercialization) or Selling, general and administrative expenses (prior to commercialization).

Samsung Bioepis is eligible for additional payments associated with pre-specified clinical and regulatory milestones. As of ~~March 31,~~September 30, 2023, potential future regulatory milestone payments of $25 million remain under the agreement.

~~Summarized information related to this collaboration is as follows:~~

Three Months Ended
March 31,
($ in millions) 2023 2022
Sales $ 116 $ 99
Cost of sales 84 65
Selling, general and administrative 18 18

In July 2023, the Company began selling

($ in millions) March 31, 2023 December 31, 2022
Receivables from Samsung included in Other current assets
$ 20 $ 21
Payables to Samsung included in Trade accounts payable
28 72
Hadlima, a biosimilar referencing Humira1 (adalimumab), in the United States.

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Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Summarized information related to this collaboration is as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
($ in millions)	2023		2022		2023		2022
Sales	$	143	$	129	$	394	$	346
Cost of sales	98		86		272		221
Selling, general and administrative	17		18		53		60


($ in millions)	September 30, 2023		December 31, 2022
Receivables from Samsung included in Other current assets	$	8	$	21
Payables to Samsung included in Trade accounts payable	62		72

14. Third-Party Arrangements

On June 2, 2021, Organon and Merck ~~& Co., Inc. ("Merck")~~ entered into a Separation and Distribution Agreement (the "Separation and Distribution Agreement"). Pursuant to the Separation and Distribution Agreement, Merck agreed to spin off the Organon Products into Organon, a new, publicly-traded company (the "Separation").

The Separation was completed pursuant to the Separation and Distribution Agreement and other agreements with Merck related to the Separation, including, but not limited to a tax matters agreement, ~~(the "Tax Matters Agreement" or "TMA"),~~ an employee matters agreement, ~~(the "Employee Matters Agreement" or "EMA"),~~ Interim Operating Model Agreements ("IOM Agreements"), Manufacturing and Supply Agreements, Intellectual Property License Agreements, Regulatory Agreements and a transition services agreement (the "Transition Service Agreement" or "TSA").

Following the Separation, certain functions continue to be provided by Merck under the TSA or are being performed using the Company's own resources or third-party service providers. Under the TSA, Merck is providing Organon various services and, similarly, Organon is providing Merck various services. The provision of certain services under the TSA ~~generally will terminate within 25 months following the spin-off;~~expired as of July 2, 2023, however, ~~the provision of~~ certain services ~~has~~have been extended to at least 35 months. Additionally, under manufacturing and supply agreements, the Company manufactures certain products for Merck, or its applicable affiliate, and Merck manufactures certain products for the Company, or its applicable affiliate. For details on the rights and responsibilities of the parties under the agreements, refer to Note 18 "Third-Party Arrangements and Related Party Disclosures" to the audited Consolidated Financial Statements in the Company's ~~2022~~Annual Report on Form ~~10-K.~~10-K for the year ended December 31, 2022.

For the three and nine months ended ~~March 31,~~September 30, 2023, material transactions occurred in connection with the IOM ~~agreements.~~Agreements.

The amounts due under such agreements were:


($ in millions)	($ in millions)	March 31, 2023		December 31, 2022		($ in millions)	September 30, 2023		December 31, 2022
Due from Merck in Accounts receivable	Due from Merck in Accounts receivable	$	344	$	374	Due from Merck in Accounts receivable	$	467	$	374
Due to Merck in Accounts payable	Due to Merck in Accounts payable	521		543		Due to Merck in Accounts payable	601		543

Sales and cost of sales resulting from the manufacturing and supply agreements with Merck were:

Three Months Ended
March 31,
($ in millions) 2023 2022
Sales $ 30 $ 33
Cost of sales 28 29


	Three Months Ended September 30,				Nine Months Ended September 30,
($ in millions)	2023		2022		2023		2022
Sales	$	28	$	38	$	95	$	104
Cost of sales	25		31		88		91

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Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

15. Contingencies

Organon is involved in various claims and legal proceedings of a nature considered normal to its business, including product liability, intellectual property, and commercial litigation, as well as certain additional matters including governmental and environmental matters.

Organon records accruals for contingencies when it is probable that a liability has been incurred and the amount can be reasonably estimated. These accruals are adjusted periodically as assessments change or additional information becomes available. Individually significant contingent losses are accrued when probable and reasonably estimable. Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable.

Given the nature of the litigation discussed in this note and the complexities involved in these matters, Organon is unable to reasonably estimate a possible loss or range of possible loss for such matters until Organon knows, among other factors, (i) what claims, if any, will survive dispositive motion practice, (ii) the extent of the claims, including the size of any potential class, particularly when damages are not specified or are indeterminate, (iii) how the discovery process will affect the litigation, (iv) the settlement posture of the other parties to the litigation, and (v) any other factors that may have a material effect on the litigation.

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~~Notes to Condensed Consolidated Financial Statements (unaudited)~~ ~~(continued)~~

Organon's decision to obtain insurance coverage is dependent on market conditions, including cost and availability, existing at the time such decisions are made. Organon has evaluated its risks and has determined that the cost of obtaining product liability insurance outweighs the likely benefits of the coverage that is available and, as such, has no insurance for most product liabilities.

Reference is made below to certain litigation in which Merck, but not Organon, is named as a defendant. Pursuant to the Separation and Distribution Agreement, Organon is required to indemnify Merck for liabilities relating to, arising from, or resulting from such litigation.

Product Liability Litigation

Fosamax

Merck is a defendant in product liability lawsuits in the United States involving Fosamax® (alendronate sodium) (the "Fosamax Litigation"). As of ~~March 31,~~September 30, 2023, approximately ~~3,245~~3,130 cases comprising the Fosamax Litigation are pending against Merck in either federal or state court. Plaintiffs in the vast majority of these cases generally allege that they sustained femur fractures and/or other bone injuries ("Femur Fractures") in association with the use of Fosamax.

All federal cases involving allegations of Femur Fractures have been or will be transferred to a multidistrict litigation in the District of New Jersey ("Femur Fracture MDL"). In the only bellwether case tried to date in the Femur Fracture MDL, Glynn v. Merck, the jury returned a verdict in Merck's favor. In addition, in June 2013, the Femur Fracture MDL court granted Merck's motion for judgment as a matter of law in the Glynn case and held that the plaintiff's failure to warn claim was preempted by federal law.

In August 2013, the Femur Fracture MDL court entered an order requiring plaintiffs in the Femur Fracture MDL to show cause why those cases asserting claims for a femur fracture injury that took place prior to September 14, 2010, should not be dismissed based on the court's preemption decision in the Glynn case. Pursuant to the show cause order, in March 2014, the Femur Fracture MDL court dismissed with prejudice approximately 650 cases on preemption grounds. Plaintiffs in approximately 515 of those cases appealed that decision to the U.S. Court of Appeals for the Third Circuit ("Third Circuit"). In March 2017, the Third Circuit issued a decision reversing the Femur Fracture MDL court's preemption ruling and remanding the appealed cases back to the Femur Fracture MDL court. In May 2019, the U.S. Supreme Court decided that the Third Circuit had incorrectly concluded that the issue of preemption should be resolved by a jury, and accordingly vacated the judgment of the Third Circuit and remanded the proceedings back to the Third Circuit to address the issue in a manner consistent with the Supreme Court's opinion. In November 2019, the Third Circuit remanded the cases back to the District Court in order to allow that court to determine in the first instance whether the plaintiffs' state law claims are preempted by federal law under the standards described by the Supreme Court in its opinion. On March 23, 2022, the District Court granted Merck's motion and ruled that plaintiffs' failure to warn claims are preempted as a matter of law to the extent they assert that Merck should have added a Warning or Precaution regarding atypical femur fractures prior to October 2010. On July 11, 2022, the District Court entered an Order to Show Cause as to why the Court should not dismiss either with prejudice or conditionally all of plaintiffs' claims that are not dependent on the preempted failure to warn claims. On November 18, 2022, as a result of the Order to Show Cause, the District Court entered a Final Judgment resulting in the dismissal with prejudice of all plaintiffs in the MDL. On

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Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

December 16, 2022, those plaintiffs filed their Notice of Appeal to the Third Circuit challenging the District Court's preemption ruling. 974 of the 975 cases previously pending in the Femur Fracture MDL have either been dismissed or are on appeal to the Third Circuit. Plaintiff's motion to remand one case back to its transferor court is pending.

As of ~~March 31,~~September 30, 2023, approximately ~~1,990~~1,880 cases alleging Femur Fractures have been filed in New Jersey state court and are pending in Middlesex County. The parties selected an initial group of cases to be reviewed through fact discovery, and Merck continued to select additional cases to be reviewed.

As of ~~March 31,~~September 30, 2023, approximately 275 cases alleging Femur Fractures have been filed and are pending in California state court. All of the Femur Fracture cases filed in California state court have been ~~coordinated~~consolidated before a single judge in Orange County, California.

Additionally, there are four Femur Fracture cases pending in other state courts.

Discovery is presently stayed in the Femur Fracture MDL and in the state court in California.

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~~Notes to Condensed Consolidated Financial Statements (unaudited)~~ ~~(continued)~~

Nexplanon/Implanon

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, which have been tolled under a written tolling agreement. As of ~~March 31,~~September 30, 2023, Merck had 18 cases pending outside the United States, of which 12 relate to Implanon and six relate to Nexplanon.

Propecia/Proscar

As of ~~March 31,~~September 30, 2023, one case involving Proscar® (finasteride) remains pending in the United States ~~a matter involving~~ ~~Proscar®~~ ~~(finasteride)~~ in the United States District Court for the Eastern District of California in which Merck's motion to dismiss was granted by the District Court, but the plaintiff can appeal the decision. The Company is also defending 1514 product liability cases involving Propecia® (finasteride) outside the United States, two of which are class actions and three of which are putative class actions.

Governmental Proceedings

From time to time, Organon's subsidiaries may receive inquiries and may be the subject of preliminary investigation activities from competition and/or other governmental authorities, including in markets outside the United States. These authorities may include regulators, administrative authorities, and law enforcement and other similar officials, and these preliminary investigation activities may include site visits, formal or informal requests or demands for documents or materials, inquiries or interviews and similar matters. Certain of these preliminary inquiries or activities may lead to the commencement of formal proceedings. Should those proceedings be determined adversely to Organon, monetary fines and/or remedial undertakings may be required. Subject to certain exceptions specified in the Separation and Distribution Agreement, Organon assumed liability for all pending and threatened legal matters related to products transferred to Organon, including competition investigations resulting from enforcement activity concerning Merck's conduct involving Organon's products. Organon could be obligated to indemnify Merck for fines or penalties, or a portion thereof, resulting from such investigations. In one such enforcement matter in Spain concerning NuvaRing, in October 2022, the National Commission on Markets and Competition ("CNMC") ~~recently~~ imposed a fine on Merck in the amount of €39 million for abuse of a dominant position in the market for contraceptive vaginal rings from June 2017 to April 2018. The CNMC decision to impose the fine has been appealed to the National High Court in Spain. If the fine ultimately stands, Organon could be obligated to indemnify Merck for a portion thereof.

Hadlima

In July 2021, Organon received a Civil Investigation Demand ("CID") from the Office of the Attorney General for the State of Washington. The CID requests answers to interrogatories, as well as various documents, regarding certain activities related to adalimumab and adalimumab biosimilars. Organon is cooperating with the government's investigation and has produced information in response to the CID.

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Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Patent Litigation

From time to time, generic manufacturers of pharmaceutical products file Abbreviated New Drug Applications with the FDA seeking to market generic forms of Organon's products prior to the expiration of relevant patents owned by Organon. To protect its patent rights, Organon may file patent infringement lawsuits against such generic companies. Similar lawsuits defending Organon's patent rights may exist in other countries. Organon intends to vigorously defend its patents, which it believes are valid, against infringement by companies attempting to market products prior to the expiration of such patents. As with any litigation, there can be no assurance of the outcomes, which, if adverse, could result in significantly shortened periods of exclusivity for these products, potential payment of damages and legal fees, and, with respect to products acquired through acquisitions, potentially significant intangible asset impairment charges.

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~~Notes to Condensed Consolidated Financial Statements (unaudited)~~ ~~(continued)~~

Nexplanon

In June 2017, Microspherix LLC ("Microspherix") sued Organon in the U.S. District Court for the District of New Jersey asserting that the manufacturing, use, sale and importation of Nexplanon infringed several of Microspherix's patents that claim radio-opaque, implantable drug delivery devices. Microspherix is claiming damages from September 2014 until the patents expired in May 2021. Organon brought Inter Partes Review proceedings in the United States Patent and Trademark Office ("USPTO") and successfully stayed the district court action. The USPTO invalidated some, but not all, of the claims asserted against Organon. Organon appealed the decisions that found claims valid, and the Court of Appeals for the Federal Circuit affirmed the USPTO's decisions. The matter is no longer stayed in the district court, and Organon is currently litigating the invalidity and non-infringement of the remaining asserted claims. A claim construction hearing was held on March 2, 2022, and a claim construction order issued on February 27, 2023. This case iswas scheduled for trial before a jury in Camden, New Jersey starting on October 16, ~~2023.~~2023; however, on October 13, 2023, a status conference was held during which the parties informed the district court that an agreement in principle of the key terms of a settlement was reached. The proceedings were stayed for 60 days to allow time for the parties to execute a settlement agreement. Organon reserved $80 million to cover the settlement.

Other Litigation

In addition to the matters described above, there are various other pending legal proceedings involving Organon, principally product liability and intellectual property lawsuits. While it is not feasible to predict the outcome of such proceedings, in the opinion of Organon as of ~~March 31,~~September 30, 2023, either the likelihood of loss is remote or any reasonably possible loss associated with the resolution of such proceedings is not expected to be material to Organon's financial condition, results of operations or cash flows either individually or in the aggregate.

Legal Defense Reserves

Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable. Some of the significant factors considered in the review of these legal defense reserves are as follows: the actual costs incurred by Organon; the development of Organon's legal defense strategy and structure in light of the scope of its litigation; the number of cases being brought against Organon; and the costs and outcomes of completed trials and the most current information regarding anticipated timing, progression, and related costs of pre-trial activities and trials in the associated litigation. The legal defense reserve as of ~~March 31,~~September 30, 2023 and December 31, 2022 was ~~$22~~$23 million and $17 million, respectively, and represented Organon's best estimate of the minimum amount of defense costs to be incurred in connection with its outstanding litigation; however, events such as additional trials and other events that could arise in the course of its litigation could affect the ultimate amount of legal defense costs to be incurred by Organon. Organon will continue to monitor its legal defense costs and review the adequacy of the associated reserves and may determine to increase the reserves at any time in the future if, based upon the factors set forth, it believes it would be appropriate to do so.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION

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," "estimate," "anticipate," "plan" or "continue." 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, pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; an inability to fully execute on our product development and commercialization plans in the United States, Europe, and elsewhere internationally; an inability to adapt to the industry-wide trend toward highly discounted channels; changes in tax laws or other tax guidance which could adversely affect our cash tax liability, effective tax rates, and results of operations and lead to greater audit scrutiny; expanded brand and class competition in the markets in which Organon operates; global tensions, which may result in disruptions in the broader global economic environment; uncertainty regarding the U.S. federal budget and debt ceiling, and the impact of a potential U.S. federal government shutdown; governmental initiatives that adversely impact our marketing activities, particularly in China; volatility in Organon’s stock price; political and social pressures, or regulatory developments, that adversely impact demand for, availability of, or patient access to contraception or fertility products; difficulties with performance of third parties Organon relies on for its business growth; the failure of any supplier to provide substances, materials, or services as agreed; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as Organon's products lose patent protection; expiration of current patents or loss of patent protection for Organon's products; difficulties ~~and uncertainties inherent in the implementation of~~implementing or executing on Organon's acquisition strategy or failure to recognize the benefits of such acquisitions; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; and other factors discussed in Organon's most recently filed Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, including those discussed in the "Business," "Risk Factors," "Cautionary Factors that May Affect Future Results" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of those reports.

General

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations is intended to assist in understanding the Company’s financial condition and results of operations. The following discussion and analysis should be read in conjunction with the Company’s Condensed Consolidated Financial Statements included in Part I, Item 1 of this report and with our audited financial statements, including the accompanying notes, and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2022. Operating results discussed herein are not necessarily indicative of the results of any future period.

Recent Developments

Business Development

Claria Medical, Inc. ("Claria")

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COVID-19 Update

COVID-19 related disruptions, including patients' inability to access health care providers, prioritization of COVID-19 patients, as well as social distancing measures, negatively affected our results during 2022 and ~~we expect that it will continue to affect our operations,~~the first half of 2023, specifically, in ~~China in 2023.~~China. During 2022 and to a lesser extent in the first ~~quarter~~half of 2023, our business was impacted by previous lockdowns in selective cities across China. The China economy has had a slower recovery post-COVID which ~~have slowed down with recent policies in China to ease~~has impacted the zero-COVID strategy. We believe that global health systems and patients continue to adapt to the evolving impacts of COVID-19. Due to the uncertainty that exists relative to the duration and overall impact of COVID-19 resulting from resurgences in COVID-19 infections or new strains of the virus, our future operating performance in China, particularly in the short-term, may be subject to volatility.retail business.

Operating Results

Sales Overview
Three Months Ended March 31, % Change % Change Excluding Foreign Exchange
($ in millions) 2023 2022
United States $ 326 $ 329 — % — %
International 1,212 1,238 (2) 3
Total $ 1,538 $ 1,567 (2) % 3 %


	Three Months Ended September 30,				% Change		% Change Excluding Foreign Exchange		Nine Months Ended September 30,				% Change	% Change Excluding Foreign Exchange
($ in millions)	2023		2022						2023		2022
United States	$	370	$	366	1	%	1	%	$	1,067	$	1,043		2	%	2	%
International	1,149		1,171		(2)		(1)		3,598		3,646			(1)		2
Total	$	1,519	$	1,537	(1)	%	(1)	%	$	4,665	$	4,689		(1)	%	2	%

Worldwide sales were $1.5 billion for the three months ended ~~March 31,~~September 30, 2023, a decrease of 2%1% compared with the same period in 2022. Worldwide sales were negatively impacted by approximately $10 million, due to unfavorable foreign exchange. Excluding foreign exchange, sales decreases primarily reflect Zetia® (ezetimibe) (marketed in most countries outside of the United States as Ezetrol™) and Vytorin® (ezetimibe/simvastatin) (marketed outside of the United States as Inegy™) driven by the impact of volume-based procurement ("VBP") in China, the Fertility portfolio mainly due to the negative impact of unfavorable discount rates in the United States, NuvaRing due to ongoing generic competition in the United States, Brenzys™ (etanercept)primarily driven by the timing of tenders in Brazil and Nexplanon due to unfavorable discount rates in the United States and decreased volume from the tender process in Mexico. This was offset by sales increases in Atozet™ (ezetimibe and atorvastatin calcium) (marketed outside of the United States) due to increased demand in France, Ontruzant driven by increased demand and the timing of tenders in Brazil and Renflexis driven primarily by continued demand growth in the United States and Canada.

Worldwide sales were $4.7 billion for the nine months ended September 30, 2023, consistent with 2022. Worldwide sales were negatively impacted by approximately 5%3%, or ~~$71~~$119 million, due to unfavorable foreign exchange. Excluding foreign exchange, sales increases primarily reflect the performance ofAtozet, due to increased demand in France and the timing of customers' buying patterns in the Middle East, Korea and Mexico, Renflexis driven primarily by continued demand growth in the United States and Canada, Arcoxia™ (etoricoxib) (marketed outside of the United States) primarily due to customers buying patterns in various international regions and higher demand in China, Jada due to continued uptake in the United States following the launch in February 2022, Dulera® (formoterol/fumarate dihydrate)primarily due to the favorable impact from discount rates and price in the United States and Marvelon™ (desogestrel and ethinyl estradiol pill) and Mercilon™ (desogestrel and ethinyl estradiol pill), resulting from the ~~recent~~ transaction with Bayer Healthcare where Organon gained full rights in selected territories in Southeast Asia and China during ~~2022,~~ ~~Renflexis,~~ ~~driven primarily by continued demand growth in the United States and Canada and~~ ~~Atozet™~~ ~~(ezetimibe and atorvastatin calcium) (marketed outside of the United States)~~, ~~due to increased demand in France.~~2022. This performance was ~~partially~~ offset by ~~declines in~~ ~~Zetia®~~Zetia ~~(ezetimibe) (marketed in most countries outside of the United States as~~ ~~Ezetrol™~~) and ~~Vytorin®~~ ~~(ezetimibe/simvastatin) (marketed outside of the United States as~~ ~~Inegy™~~)Vytorin driven by the impact of ~~volume-based procurement ("VBP")~~VBP in China, ~~and increased competition and lower performance in Europe coupled with~~ the impact of the Diprospan™ ~~(betamethasone cream) market actions taken during~~(betamethasone) regulatory inspection finding at the ~~first quarter~~Heist manufacturing location that impacted the manufacturing of ~~2023. Within our established~~selected injectable steroid brands ~~portfolio, respiratory products were positively impacted~~(the "Market Action") and decreased sales of Cozaar® (losartan potassium)and Hyzaar® (a combination of losartan potassium and hydrochlorothiazide that is marketed in ~~the prior year,~~Japan as Preminent™), primarily due to ~~higher demand from competitors' supply disruptions in Japan.~~ongoing generic competition.

The loss of exclusivity ~~("LOE")~~ negatively impacted sales by approximately $2$7 million and $9 million during the three and nine months ended ~~March 31,~~September 30, 2023, compared to the three and nine months ended ~~March 31,~~September 30, 2022, based on the decrease in volume period over period, mainly impacting NuvaRing in the United States. VBP in China had a ~~$27~~$31 million and $83 million negative impact on sales during the three and nine months ended ~~March 31,~~September 30, 2023, compared to the three and nine months ended ~~March 31,~~September 30, 2022. Organon expects VBP to impact the Company's established brands product portfolio for the next several quarters.

Organon's operations include a portfolio of products. Highlights of the sales of Organon's products for the three and nine months ended ~~March 31,~~September 30, 2023 and 2022 are provided below. See Note 5 "Product and Geographic Information" to the Condensed Consolidated Financial Statements for further details on sales of our products.

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Women's Health


		Three Months Ended March 31,			% Change			% Change Excluding Foreign Exchange						Three Months Ended September 30,						% Change				% Change Excluding Foreign Exchange			Nine Months Ended September 30,						% Change			% Change Excluding Foreign Exchange
($ in millions)	($ in millions)	2023	2022							($ in millions)	2023			2022							2023						2022
Nexplanon/Implanon NXT	Nexplanon/Implanon NXT		$	165		$	171					(3)	%		(1)	%						Nexplanon/Implanon NXT		$	220		$	229		(4)	%			(3)	%		$	599		$	595			1	%	2	%
NuvaRing	NuvaRing		40		41				(2)			(1)						NuvaRing		37				50			(26)			(23)			117			133				(12)			(10)
Marvelon/Mercilon	Marvelon/Mercilon		37		24				58			65						Marvelon/Mercilon		30				31			(3)			(2)			97			85				13			17
Follistim AQ	Follistim AQ		55		61				(10)			(7)						Follistim AQ		54				60			(10)			(8)			179			179				—			3
Ganirelix Acetate Injection	Ganirelix Acetate Injection		30		30				—			3						Ganirelix Acetate Injection		25				36			(30)			(29)			88			97				(9)			(7)
Jada																	Jada		13				5			134			134			31			12				150			150

Contraception

Worldwide sales of Nexplanon, a single-rod subdermal contraceptive implant, ~~declined 3%~~decreased 4% for the three months ended ~~March 31,~~September 30, 2023, compared to 2022 due to unfavorable discount rates in the United States and decreased volume from the tender process in Mexico. Sales of Nexplanon increased 1% for the nine months ended September 30, 2023, compared to 2022, primarily due to price increases, the impact of the timing of tenders in various international markets and the impact of distributors' buying patterns in prior periods in the ~~U.S.~~United States, offset by unfavorable discount rates in the United States.

Worldwide sales of NuvaRing, a vaginal contraceptive product, declined 2%26% and 12% for the three and nine months ended ~~March 31,~~September 30, 2023, respectively, compared to 2022, due to ongoing generic competition in the United States. We expect a continued decline in NuvaRing sales as a result of generic competition.

Worldwide sales of Marvelon and Mercilon, combined oral hormonal daily contraceptive pills not approved or marketed in the United States but available in certain countries outside the United States, ~~increased 58%~~remained consistent for the three months ended ~~March 31,~~September 30, 2023, compared to 2022. Sales of Marvelon and Mercilon increased 13% for the nine months ended September 30, 2023, compared to 2022, as a result of the ~~recent~~ transaction with Bayer Healthcare where Organon gained full rights in selected territories in Southeast Asia and China during 2022.

Fertility

Worldwide sales of Follistim AQ, a fertility treatment, declined 10% for the three months ended ~~March 31,~~September 30, 2023, compared to 2022, due to the ~~unfavorable~~negative impact of ~~COVID-19 in China and an~~ unfavorable ~~shift in customer mix and~~ discount rates in the United States ~~partially~~ offset by ~~an increase~~increased demand. Sales of FollistimAQ remained consistent for the nine months ended September 30, 2023, compared to 2022, due to volume recovery in ~~product demand~~China related to the COVID-19 negative impact during the first half of the year, offset by the negative impact of unfavorable discount rates in the United States.

Worldwide sales of Ganirelix Acetate Injection (marketed in certain countries outside the United States as Orgalutran™), a fertility treatment, ~~remained consistent~~declined 30% and 9% for the three and nine months ended ~~March 31,~~September 30, 2023, respectively, compared to ~~2022.~~2022, primarily due to unfavorable discount rates in the United States and the impact of distributors' buying patterns in several markets.

Other Women's Health

Worldwide sales of Jada, a device intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, increased 134% and 150% for the three and nine months ended September 30, 2023, respectively, compared to 2022. The sales increase in both periods is due to continued uptake in the United States following the Jadalaunch.

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Biosimilars


		Three Months Ended March 31,			% Change			% Change Excluding Foreign Exchange						Three Months Ended September 30,				% Change			% Change Excluding Foreign Exchange		Nine Months Ended September 30,				% Change			% Change Excluding Foreign Exchange
($ in millions)	($ in millions)	2023	2022							($ in millions)	2023			2022					2023				2022
Renflexis	Renflexis		$	62		$	46					34	%		34	%				Renflexis	$	69	$	60	15	%		15	%		$	201	$	166		22	%	22	%
Ontruzant	Ontruzant		21		22				(7)			(6)					Ontruzant	40			29		36		34		93			87			8		7
Brenzys	Brenzys		19		14				31			36					Brenzys	13			24		(43)		(41)		45			52			(13)		(8)
Hadlima	Hadlima		5		6				(20)			(16)					Hadlima	8			6		38		42		20			14			48		55

Renflexis is a biosimilar to Remicade1 (infliximab) ~~(a trademark of Janssen Biotech, Inc.)~~ for the treatment of certain inflammatory diseases. Sales growth of ~~34%~~15% and 22% for the three and nine months ended ~~March 31,~~September 30, 2023, respectively, compared to 2022, was driven primarily by continued demand growth in the United States and Canada. We have commercialization rights to Renflexis in countries outside Europe, Korea, China, Turkey, and Russia.

Ontruzant ~~(trastuzumab-dttb)~~ is a biosimilar to Herceptin1 (trastuzumab) ~~(a trademark of Genentech, Inc.)~~ for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Sales in the three and nine months ended ~~March 31,~~September 30, 2023, ~~declined 7%~~compared to 2022, increased 36% and 8%, respectively, driven by increased demand and the timing of tenders in Brazil partially offset by the competitive pressures in ~~Europe offset by the continued uptake in the United States since its launch in July 2020 and the favorable phasing and timing of tenders in Brazil.~~Europe. We have commercialization rights to Ontruzant in countries outside of Korea and China.

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~~Brenzys™~~Brenzys ~~(etanercept)~~ is a biosimilar to Enbrel1 (etanercept) ~~(a trademark of Immunex Corporation)~~for the treatment of certain inflammatory diseases. Sales in the three and nine months ended ~~March 31,~~September 30, 2023, ~~increased 31%~~compared to 2022, declined 43% and 13%, respectively, primarily driven by the timing of tenders in Brazil. We have commercialization rights to Brenzys in countries outside of the United States, Europe, Korea, China, and Japan.

~~Hadlima™~~Hadlima ~~(adalimumab-bwwd)~~ is a biosimilar to Humira1 (adalimumab) ~~(a trademark of AbbVie Biotechnology Ltd.)~~ for the treatment of certain inflammatory diseases. We have ~~worldwide~~ commercialization rights to Hadlima in countries outside of the EU, Korea, China, Turkey, and Russia. ~~Samsung Bioepis reached a global settlement with AbbVie permitting us to launch~~ ~~Hadlima~~ ~~outside of the United States starting in 2021 and in the United States in July 2023.~~ Hadlima is currently approved in the United States, Australia, Canada, and Israel. ~~Hadlima~~ ~~was launched in Australia and Canada in February 2021.~~ We recorded sales of $5$8 million and $20 million during the three and nine months ended ~~March 31,~~September 30, 2023, respectively, reflecting ~~a decline~~an increase from modest sales during ~~the three months ended March 31,~~ 2022 in markets outside of the ~~U.S.~~United States and the launch in the United States in July 2023.

Established Brands

Established brands represents a broad portfolio of well-known brands, which generally are beyond market exclusivity, including leading brands in cardiovascular, respiratory, dermatology and non-opioid pain management, for which generic competition varies by market.

Cardiovascular


		Three Months Ended March 31,			% Change			% Change Excluding Foreign Exchange						Three Months Ended September 30,				% Change			% Change Excluding Foreign Exchange		Nine Months Ended September 30,				% Change			% Change Excluding Foreign Exchange
($ in millions)	($ in millions)	2023	2022							($ in millions)	2023			2022					2023				2022
Zetia/Vytorin	Zetia/Vytorin		$	112		$	137					(18)	%		(13)	%				Zetia/Vytorin	$	99	$	118	(16)	%		(16)	%		$	339	$	390		(13)	%	(11)	%
Atozet	Atozet		128		119				8			13					Atozet	126			109		16		10		397			350			14		14
Cozaar/Hyzaar	Cozaar/Hyzaar		85		93				(9)			(2)					Cozaar/Hyzaar	68			70		(2)		2		225			256			(12)		(7)

Combined global sales of Zetia and Vytorin, medicines for lowering LDL cholesterol, declined ~~18%~~16% and 13% for the three and nine months ended ~~March 31,~~September 30, 2023, respectively, compared to 2022, primarily driven by the impact of VBP ~~in China and increased competition and lower performance in Europe partially offset by growing demand in the retail channel~~ in China.

Sales of Atozet, a medicine for lowering LDL cholesterol, increased 8%16% and 14% for the three and nine months ended ~~March 31,~~September 30, 2023, respectively, compared to 2022, primarily due to increased demand in France and the timing of customers' buying patterns in ~~several markets in~~ the ~~Asia Pacific region.~~Middle East, Korea, and Mexico.

Combined global sales of ~~Cozaar®~~ Cozaar~~(losartan potassium),~~ and ~~Hyzaar®~~Hyzaar ~~(losartan potassium and hydrochlorothiazide) (a combination of losartan potassium and hydrochlorothiazide that is marketed in Japan as~~ ~~Preminent™~~), ~~a medicine~~medicines for the treatment of hypertension, declined 9%2% and 12% for the three and nine months ended ~~March 31,~~September 30, 2023, respectively, compared to 2022, primarily due to ~~wholesaler and distributor buying patterns in China, competitors' supply disruptions in various markets during 2022 and~~ ongoing generic competition.

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Respiratory


		Three Months Ended March 31,			% Change			% Change Excluding Foreign Exchange						Three Months Ended September 30,				% Change			% Change Excluding Foreign Exchange		Nine Months Ended September 30,				% Change			% Change Excluding Foreign Exchange
($ in millions)	($ in millions)	2023	2022							($ in millions)	2023			2022					2023				2022
Singulair	Singulair		$	120		$	130					(8)	%		—	%				Singulair	$	91	$	94	(4)	%		—	%		$	290	$	316		(8)	%	(3)	%
Nasonex	Nasonex		69		75				(8)			(4)					Nasonex	55			49		10		16		188			182			3		7
Dulera	Dulera		46		40				15			16					Dulera	49			40		24		24		144			127			13		14

Worldwide sales of Singulair® (montelukast sodium), a once-a-day oral medicine for the chronic treatment of asthma and for the relief of symptoms of allergic rhinitis, ~~declined 8% for~~remained consistent during the three months ended ~~March 31,~~September 30, 2023 compared to 2022. Sales of Singulair declined8% during the nine months ended September 30, 2023, compared to 2022, ~~because of~~due to increased pricing pressures in China related to renewal contracts for hospital tenders and the alleviation of our ~~competitors~~'competitors' supply disruptions in Japan during 2022, which had positively impacted demand for Singulair in ~~2022, as well as the~~ ~~unfavorable impact of foreign exchange.~~

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2022.

Global sales of Nasonex® (mometasone), an inhaled nasal corticosteroid for the treatment of nasal allergy symptoms, ~~declined 8%~~increased 10% and 3% during the three and nine months ended ~~March 31,~~September 30, 2023, compared to 2022, due to increased demand across several markets partially offset by a $10 million milestone payment related to a regulatory approval received during ~~2022 partially offset by increased demand across several markets.~~the first quarter of 2022.

Global sales of ~~Dulera®~~Dulera~~(formoterol/fumarate dihydrate)~~, a combination medicine for the treatment of asthma, increased ~~15%~~24% and 13% for the three and nine months ended ~~March 31,~~September 30, 2023, respectively, compared to 2022, primarily due to ~~volume growth, and~~ the favorable impact from discount rates and price in the United States.

Non-Opioid Pain, Bone and Dermatology


		Three Months Ended March 31,			% Change			% Change Excluding Foreign Exchange							Three Months Ended September 30,				% Change			% Change Excluding Foreign Exchange		Nine Months Ended September 30,				% Change			% Change Excluding Foreign Exchange
($ in millions)	($ in millions)	2023	2022								($ in millions)	2023			2022					2023				2022
Arcoxia	Arcoxia		$	71		$	60						17	%		22	%				Arcoxia	$	64	$	64	—	%		5	%		$	207	$	185		12	%	16	%
Diprospan	Diprospan		14		31				(54)	%			(54)	%				Diprospan	31			28		10		11		58			91			(37)		(36)

Sales of ~~Arcoxia™~~Arcoxia ~~(etoricoxib) (marketed outside of the United States)~~, a medicine for the treatment of arthritis and pain, ~~increased 17%~~remained consistent during the three months ended ~~March 31,~~September 30, 2023 compared to 2022. Sales of Arcoxia increased 12% during the nine months ended September 30, 2023, compared to 2022, primarily due to customers buying patterns in ~~the South East Asia region~~various international regions and higher demand in China.

Sales of Diprospan, a corticosteroid approved for treatment of wide range of inflammatory conditions, ~~declined 54%~~increased 10% during the three months ended ~~March 31,~~September 30, 2023 compared to 2022 as the Company replenishes supply from the Market Action. Sales of Diprospan declined 37% during the nine months ended September 30, 2023, compared to 2022, due to the ~~regulatory inspection finding at~~Market Action. In the ~~Heist manufacturing location that impacted the manufacturing~~first quarter of ~~selected injectable steroid brands. As of March 31, 2023,~~202

3, we ~~have~~ resolved the regulatory inspection findings. The Company expects sales recovery to continue to occur over the next twelve months.

Other


		Three Months Ended March 31,			% Change			% Change Excluding Foreign Exchange					Three Months Ended September 30,			% Change			% Change Excluding Foreign Exchange		Nine Months Ended September 30,				% Change			% Change Excluding Foreign Exchange
($ in millions)	($ in millions)	2023	2022						($ in millions)	2023			2022				2023				2022
Proscar	Proscar		$	27		$	24				13	%		22	%			Proscar	$	25	$	27	(6)	%		(2)	%		$	77	$	77	—	%	6	%

Worldwide sales of Proscar, a medicine for the treatment of symptomatic benign prostate enlargement, ~~increased 13%~~ for the three and nine months ended ~~March 31,~~September 30, 2023 ~~compared to 2022, primarily due to increased demand~~were substantially consistent with sales for the corresponding periods in ~~China.~~2022.

~~Costs, Expenses and Other~~

Three Months Ended March 31, % Change
($ in millions) 2023 2022
Cost of sales $ 580 $ 561 3 %
Selling, general and administrative 435 371 17
Research and development 129 96 34
Acquired in-process research and development and milestones 8 — *
Restructuring costs 4 — *
Interest expense 132 97 36
Exchange losses (gains) 9 (4) *
Other expense, net 6 4 50
$ 1,303 $ 1,125 16 %

* Calculation not meaningful.

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Costs, Expenses and Other


	Three Months Ended September 30,				% Change		Nine Months Ended September 30,				% Change
($ in millions)	2023		2022				2023		2022
Cost of sales	$	612	$	551	11	%	$	1,832	$	1,700		8	%
Selling, general and administrative	538		440		22		1,424		1,234			15
Research and development	137		127		8		394		329			20
Acquired in-process research and development and milestones	—		10		(100)		8		107			(93)
Restructuring costs	—		11		(100)		4		11			(64)
Interest expense	134		108		24		398		303			31
Exchange losses (gains)	14		4		*		25		(21)			*
Other expense, net	4		4		—		11		15			(27)
	$	1,439	$	1,255	15	%	$	4,096	$	3,678		11	%

* Calculation not meaningful.

Cost of Sales

Cost of sales increased 3%11% and 8% for the three and nine months ended ~~March 31,~~September 30, 2023, respectively, compared to the same ~~period~~periods in 2022, primarily due to ~~product mix as well as~~foreign exchange translation, higher employee-related costs and distribution related costs, which increased as a result of inflationary ~~pressures.~~pressures, and product mix. During the nine months ended September 30, 2022, the Company recorded an impairment charge of $9 million related to a product right for a biosimilar product.

Selling, General and Administrative

Selling, general and administrative expenses increased ~~17%~~22% and 15% for the three and nine months ended ~~March 31,~~September 30, 2023, respectively, compared to the same period in 2022, due to higher ~~promotional and~~ employee-related costs, ~~and~~ costs incurred in connection with the separation from Merck, which includes the implementation of the enterprise resource planning ~~system.~~system, and the $80 million charge related to the Microspherix legal matter as discussed in Note 15. "Contingencies" to the Condensed Consolidated Financial Statements.

Research and Development

Research and development expenses increased ~~34%~~8% and 20% for the three and nine months ended ~~March 31,~~September 30, 2023, respectively, compared to the same period in 2022, primarily due to higher costs associated with the Company's recent acquisitions of clinical stage assets, increased clinical study activity and higher employee-related costs.

Acquired In-Process Research and Development and Milestones

For the ~~three~~nine months ended ~~March 31,~~September 30, 2023, acquired in-process research and development and milestones of $8 million related to the Claria transaction. For the three months ended September 30, 2022, acquired in-process research and development and milestones represents the upfront milestones related to the Cirqle transaction. For the nine months ended September 30, 2022 acquired in-process research and development and milestones represents the upfront and development milestones related to both the Cirqle and Henlius transactions.

Restructuring Costs

For the ~~three~~nine months ended ~~March 31,~~September 30, 2023, the Company incurred $4 million of headcount related restructuring expense as part of the restructuring activities which were initiated during 2022 to optimize its internal operations.

Interest Expense

For the three months ended ~~March 31,~~September 30, 2023, interest expense increased due to increased interest rates on our term loans. For the nine months ended September 30, 2023, interest expense increased due to increased interest rates, unamortized debt fees and discounts expensed as part of the prepayment on the U.S. Dollar-denominated term loan and the impact of exchange rates.

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Exchange Losses (Gains)

For the three and nine months ended ~~March 31,~~September 30, 2023, the change in exchanges losses (gains) was driven by foreign currency translation losses as well as the impact of the portion of Euro-denominated debt not designated as a net investment hedge in the prior year period.

Other ~~expense,~~Expense, net

For the three and nine months ended ~~March 31,~~September 30, 2023, other expense, net, remained relatively consistent with the prior year.

Taxes on Income

The effective income tax rates were ~~24.6%~~27.0% and ~~21.3%~~19.6% for the three months ended ~~March 31,~~September 30, 2023 and 2022, respectively, and 16.1% and 20.0% for the nine months ended September 30, 2023 and 2022, 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 partial valuation allowance recorded against non-deductible U.S. interest expense. The 2023 quarter-to-date and year-to-date effective tax rate favorable impact is primarily attributable to a reduced tax rate arrangement that was agreed to in Switzerland for an active entity.

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~~Analysis of Liquidity and Capital Resources~~

Liquidity and Capital Resources

As of ~~March 31,~~September 30, 2023, Organon had cash and cash equivalents of ~~$459~~$414 million.

Working capital ~~remained consistent at~~was $1.6 billion and $1.4 billion as of ~~March 31,~~September 30, 2023 and December 31, 2022, respectively. The increase in working capital was primarily driven by an increase in inventory and the timing of collection of receivables.

Net cash provided by operating activities was ~~$114~~$402 million for the ~~three~~nine months ended ~~March 31,~~September 30, 2023 compared to ~~$123~~$591 million for the same period in the prior year. The decrease in cash provided by operating activities was primarily attributable to lower net income partially offset by the changes in working capital ~~balances, largely reflecting a prior year reduction in the net balances due to Merck.~~balances.

Net cash used in investing activities was ~~$54~~$179 million for the ~~three~~nine months ended ~~March 31,~~September 30, 2023 compared to ~~$63~~$359 million for the same period in the prior year, primarily reflecting ~~the strategic~~lower investment in ~~Claria and~~business development transactions in the nine months ended September 30, 2023 compared to the same period in the prior year, partially offset by an increase in capital ~~expenditures in the three months ended March 31, 2023 compared with the asset acquisition of~~ ~~Marvelon~~ ~~and~~ ~~Mercilon~~ ~~in the three months ended March 31, 2022.~~expenditures.

Net cash used in financing activities was ~~$326~~$492 million for the ~~three~~nine months ended ~~March 31,~~September 30, 2023 compared to ~~$91~~$351 million for the same period in the prior year. The increase in cash used in financing activities was driven by the $250 million voluntary prepayment on the U.S. Dollar-denominated term ~~loan.~~loan in the first quarter of 2023.

Organon will continue to monitor the impacts of the ~~conflict between Ukraine~~Ukraine-Russia war and ~~Russia,~~the Hamas-Israel war, which may negatively impact Organon's operations, financial position, or cash flows. For the three and nine months ended ~~March 31,~~September 30, 2023 and 2022, Organon's combined revenues from Ukraine, Russia and ~~Russia~~Israel were approximately 2% of total revenues. As of ~~March 31,~~September 30, 2023, the Company's assets in Ukraine, Russia and ~~Russia~~Israel are not material.

Our contractual obligations as of ~~March 31,~~September 30, 2023, which require material cash requirements in the future, consist of contractual milestones, purchase obligations and lease obligations. In addition, Organon is responsible for settlement of certain tax matters that the Company expects to pay during 2023. Refer to "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our ~~2022~~Annual Report on Form 10-K for the year ended December 31, 2022 for further details. The Company ~~owes~~has terminated the ebopiprant license agreement and development program; as a result, the Company will not owe the previously disclosed $25 million milestone ~~upon acceptance of~~payment or other milestone payments under the ~~IND filing for ebopiprant. We anticipate the milestone could be triggered as early as the second quarter of 2023.~~ebopiprant license agreement. As of ~~March 31,~~September 30, 2023, there have been no material changes to our contractual obligations, or settlements of tax matters outside the ordinary course of business.

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During the ~~first~~third quarter of 2023, Organon paid cash dividends of $0.28 per share. On ~~May 4,~~November 2, 2023, the Board of Directors declared a quarterly dividend of $0.28 for each issued and outstanding share of the Company's common stock. The dividend is payable on ~~June 15,~~December 14, 2023, to stockholders of record at the close of business on ~~May 15,~~November 13, 2023.

The Company has historically generated and expects to continue to generate positive cash flow from operations. Our ability to fund our operations and anticipated capital needs is reliant upon the generation of cash from operations, supplemented as necessary by periodic utilization of our Revolving Credit Facility. Our principal uses of cash in the future will be primarily to fund our operations, working capital needs, capital expenditures, repayment of borrowings, payment of dividends and strategic business development transactions. We believe that our financing arrangements, future cash from operations, and access to capital markets will provide adequate resources to fund our future cash flow needs.

Critical Accounting Estimates

Our significant accounting policies, which include management’s best estimates and judgments, are included in Note 3 "Summary of Accounting Policies" to the Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2022. See Note 2 "Basis of Presentation" to the Condensed Consolidated Financial Statements for information on the adoption of new accounting standards during 2023. There have been no changes to our accounting policies as of ~~March 31,~~September 30, 2023. A discussion of accounting estimates considered critical because of the potential for a significant impact on the financial statements due to the inherent uncertainty in such estimates are disclosed in the Critical Accounting Estimates section of Management’s Discussion and Analysis of Financial Condition and Results of Operations included in Organon's Annual Report on Form 10-K for the year ended December 31, 2022.

Recently Issued Accounting Standards

For a discussion of recently issued accounting standards, see Note 2 "Basis of Presentation" to the Condensed Consolidated Financial Statements.

~~-28-~~

~~Table of Contents~~

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Foreign Currency Risk

We operate on a global basis and are exposed to the risk that our earnings, cash flows and equity could be adversely affected by fluctuations in foreign exchange rates. We are primarily exposed to foreign exchange risk with respect to forecasted transactions and net assets denominated in the euro, Swiss franc, and Japanese yen. We established a balance sheet risk management program and a net investment hedge to mitigate against volatility of changes in foreign exchange rates. See Note 10 "Financial Instruments" to the Condensed Consolidated Financial Statements included elsewhere in this report for further information on Organon’s risk management.

Interest Rate Risk

Our long-term debt portfolio consists of both fixed and variable-rate instruments. For any variable rate debt, interest rate changes in the underlying index rates will impact future interest expense. We do not hold any derivative contracts that hedge our interest rate risk; however, we may consider entering into such contracts in the future.

There have been no changes to Organon’s market risk during the quarter ended ~~March 31,~~September 30, 2023. 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, 2022.

Item 4. Controls and Procedures

Management of the Company, with the participation of its Chief Executive Officer ("CEO") and Chief Financial Officer ("CFO"), evaluated the effectiveness of the design and operation of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the period ending ~~March 31,~~September 30, 2023. Based upon that evaluation, our CEO and our CFO concluded that, as of ~~March 31,~~September 30, 2023, the end of the period covered by this report, the Company's disclosure controls and 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 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.

~~In 2022, the~~

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The Company began an implementation of an enterprise resource planning ("ERP") system, which will replace the existing core financial system. The ERP system is designed to accurately maintain the Company's financial records used to report operating results. The implementation of the consolidated financial reporting module will be completed during Q4 of the 2023 fiscal ~~year and the~~year. The implementation of the general ledger modules ~~will occur~~is in progress and occurring in phases and ~~will~~is expected to be completed by the first half of 2024. The ~~Company~~changes in process under the new ERP will ~~evaluate each~~continue to be subject to our evaluation of the operating effectiveness of internal control over financial reporting.

Except for the implementation of an ERP system, there was no change in our internal control over financial reporting that occurred during the quarter ~~whether there are changes~~ended September 30, 2023 that has materially ~~affect,~~affected, or ~~are~~is reasonably likely to materially affect, our internal control over financial reporting.

During the quarter ended March 31, 2023, there have been no changes in internal control over financial reporting that materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting.

PART II - OTHER INFORMATION

Item 1. Legal Proceedings

The information called for by this Item is incorporated herein by reference to Note 15 "Contingencies" included in Part I, Item. 1.

Item 1A. Risk Factors

There have been no material changes in the Company's risk factors from those disclosed in Item 1A. Risk Factors, in our Annual Report on Form 10-K for the year ended December 31, ~~2022.~~2022 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2023.

Item 5. Other Information

During the three months ended September 30, 2023, no director or officer of the company 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.

~~-29-~~

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Item 6. Exhibits


Number			Description


	10.1		Amendment No. 1 to Senior Secured Credit Agreement, dated as of June 30, 2023, to the Credit Agreement by and among Organon & Co., Organon Foreign Debt Co-Issuer B.V., JPMorgan Chase Bank, N.A., as Administrative Agent, Collateral Agent, and the L/C Issuers and Lenders party thereto (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K (File No. 001-40235) filed on July 7, 2023).
	*31.1	—	Certification of Principal Executive Officer (CEO) pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
	*31.2	—	Certification of Principal Financial Officer (CFO) pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
	**32.1	—	Section 1350 Certification of Principal Executive Officer (CEO) pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
	**32.2	—	Section 1350 Certification of Principal Financial Officer (CFO) pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS		—	XBRL Instance Document - The instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document.

101.SCH		—	XBRL Taxonomy Extension Schema Document.

101.CAL		—	XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF		—	XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB		—	XBRL Taxonomy Extension Label Linkbase Document.

101.PRE		—	XBRL Taxonomy Extension Presentation Linkbase Document.

	104	—	Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).


		*	Filed herewith
		**	Furnished herewith

1Indicates, in this Form 10-Q for Quarter Ending September 30, 2023, brand names of products, which are trademarks not owned by the Company or its subsidiaries. Humira is a trademark registered in the United States in the name of AbbVie Biotechnology Ltd.; Enbrel is a trademark registered in the United States in the name of Immunex Corporation; Remicade is a trademark registered in the United States in the name of Janssen Biotech, Inc.; and Herceptin is a trademark registered in the United States in the name of Genentech, Inc. Brand names of products that are in all italicized letters, without the footnote, are trademarks of, or are otherwise licensed by, Organon and/or one of its subsidiaries.

~~-30-~~

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Signatures

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.


						ORGANON & CO.

Date: ~~May 5,~~November 3, 2023						/s/ Kathryn DiMarco
						Kathryn DiMarco
						Senior Vice President Finance - Corporate Controller

Date: ~~May 5,~~November 3, 2023						/s/ Matthew Walsh
						Matthew Walsh
						Chief Financial Officer


Delaware		46-4838035
(State or other jurisdiction of incorporation)		(I.R.S. Employer Identification No.)

30 Hudson Street, Floor 33
Jersey City,	New Jersey	07302
(Address of principal executive offices) (zip code)


							September 30, 2023		December 31, 2022
		March 31, 2023		December 31, 2022
Assets	Assets					Assets
Current Assets
Current Assets:						Current Assets:
Cash and cash equivalents	Cash and cash equivalents	$	459	$	706	Cash and cash equivalents	$	414	$	706
Accounts receivable (net of allowance for doubtful accounts of $9 in 2023 and $9 in 2022)	Accounts receivable (net of allowance for doubtful accounts of $9 in 2023 and $9 in 2022)	1,445		1,475		Accounts receivable (net of allowance for doubtful accounts of $9 in 2023 and $9 in 2022)	1,648		1,475
Inventories (excludes inventories of $87 in 2023 and $148 in 2022 classified in Other assets)		1,121		1,003
Inventories (excludes inventories of $95 in 2023 and $148 in 2022 classified in Other assets)						Inventories (excludes inventories of $95 in 2023 and $148 in 2022 classified in Other assets)	1,186		1,003
Other current assets	Other current assets	755		747		Other current assets	802		747
Total current assets		3,780		3,931
Total Current Assets						Total Current Assets	4,050		3,931
Property, plant and equipment, net	Property, plant and equipment, net	1,055		1,018		Property, plant and equipment, net	1,096		1,018
Goodwill	Goodwill	4,603		4,603		Goodwill	4,603		4,603
Intangibles, net	Intangibles, net	621		649		Intangibles, net	561		649
Other assets	Other assets	704		754		Other assets	702		754
Total Assets						Total Assets	$	11,012	$	10,955
		$	10,763	$	10,955
Liabilities and Equity	Liabilities and Equity					Liabilities and Equity
Current Liabilities
Current Liabilities:						Current Liabilities:
Current portion of long-term debt	Current portion of long-term debt	$	8	$	8	Current portion of long-term debt	$	8	$	8
Trade accounts payable	Trade accounts payable	996		1,132		Trade accounts payable	1,067		1,132
Accrued and other current liabilities	Accrued and other current liabilities	1,150		1,188		Accrued and other current liabilities	1,255		1,188
Income taxes payable	Income taxes payable	192		184		Income taxes payable	161		184
Total current liabilities		2,346		2,512
Total Current Liabilities						Total Current Liabilities	2,491		2,512
Long-term debt	Long-term debt	8,703		8,905		Long-term debt	8,646		8,905
Deferred income taxes	Deferred income taxes	30		19		Deferred income taxes	43		19
Other noncurrent liabilities	Other noncurrent liabilities	421		411		Other noncurrent liabilities	421		411
Total Liabilities						Total Liabilities	11,601		11,847
Contingencies (Note 15)	Contingencies (Note 15)					Contingencies (Note 15)

Organon & Co. Stockholders' Deficit
Common stock, $0.01 par value Authorized - 500,000 Issued and outstanding - 254,432 in 2023 and 254,370 in 2022		3		3
Organon & Co. Stockholders' Deficit:						Organon & Co. Stockholders' Deficit:
Common stock, $0.01 par value Authorized - 500,000 Issued and outstanding - 255,606 in 2023 and 254,370 in 2022						Common stock, $0.01 par value Authorized - 500,000 Issued and outstanding - 255,606 in 2023 and 254,370 in 2022	3		3
Accumulated deficit	Accumulated deficit	(206)		(331)		Accumulated deficit	(16)		(331)
Accumulated other comprehensive loss	Accumulated other comprehensive loss	(534)		(564)		Accumulated other comprehensive loss	(576)		(564)
Total Stockholders' Deficit	Total Stockholders' Deficit	(737)		(892)		Total Stockholders' Deficit	(589)		(892)
		$	10,763	$	10,955
Total Liabilities and Stockholders' Deficit						Total Liabilities and Stockholders' Deficit	$	11,012	$	10,955


		Stock Options					Restricted Share Units			Performance Share Units				Stock Options					Restricted Share Units			Performance Share Units
(shares in thousands)	(shares in thousands)	Shares	Weighted average exercise price		Weighted average grant date fair value		Shares	Weighted average grant date fair value		Shares	Weighted average grant date fair value		(shares in thousands)	Shares	Weighted average exercise price		Weighted average grant date fair value		Shares	Weighted average grant date fair value		Shares	Weighted average grant date fair value
Outstanding as of January 1, 2023	Outstanding as of January 1, 2023	4,729	$	34.34	$	8.91	5,048	$	33.27	486	$	46.72	Outstanding as of January 1, 2023	4,729	$	34.34	$	8.91	5,048	$	33.27	486	$	46.72
Granted	Granted	1,124	23.52		6.55		3,730	23.56		—	—		Granted	1,124	23.52		6.55		3,867	23.51		636	23.30
Vested/Exercised	Vested/Exercised	—	—		—		(1,080)	32.00		—	—		Vested/Exercised	—	—		—		(1,930)	33.93		—	—
Forfeited/Cancelled	Forfeited/Cancelled	(82)	36.12		8.70		(221)	34.54		—	—		Forfeited/Cancelled	(89)	36.12		8.70		(459)	30.79		—	—
Outstanding as of March 31, 2023		5,771	$	32.21	$	8.45	7,477	$	28.57	486	$	46.72
Outstanding as of September 30, 2023													Outstanding as of September 30, 2023	5,764	$	32.21	$	8.45	6,526	$	27.47	1,122	$	33.44


		Equity Awards Vested and Expected to Vest						Equity Awards That are Exercisable							Equity Awards Vested and Expected to Vest						Equity Awards That are Exercisable
(shares in thousands; aggregate intrinsic value in millions)		Awards	Weighted Average Exercise Price		Aggregate Intrinsic Value		Remaining Term	Awards	Weighted Average Exercise Price		Aggregate Intrinsic Value		Remaining Term
(awards in thousands; aggregate intrinsic value in millions)														(awards in thousands; aggregate intrinsic value in millions)	Awards	Weighted Average Exercise Price		Aggregate Intrinsic Value		Remaining Term (in years)	Awards	Weighted Average Exercise Price		Aggregate Intrinsic Value		Remaining Term (in years)
Stock Options	Stock Options	5,517	$	32.21	$	—	7.55	2,536	$	33.03	$	—	5.90	Stock Options	5,591	$	32.21	$	—	7.04	3,311	$	33.79	$	—	5.87
Restricted Share Units	Restricted Share Units	6,809			176		2.36							Restricted Share Units	6,071			114		1.98
Performance Share Units	Performance Share Units	291			8		1.67							Performance Share Units	629			12		1.82


($ in millions)	($ in millions)	March 31, 2023		December 31, 2022		($ in millions)	September 30, 2023		December 31, 2022
Finished goods	Finished goods	$	479	$	482	Finished goods	$	496	$	482
Raw materials	Raw materials	58		44		Raw materials	128		44
Work in process	Work in process	631		601		Work in process	606		601
Supplies	Supplies	56		44		Supplies	57		44
Total (approximates current cost)	Total (approximates current cost)	$	1,224	$	1,171	Total (approximates current cost)	$	1,287	$	1,171
Decrease to LIFO costs	Decrease to LIFO costs	(16)		(20)		Decrease to LIFO costs	(6)		(20)
		$	1,208	$	1,151		$	1,281	$	1,151
Recognized as:	Recognized as:					Recognized as:
Inventories	Inventories	$	1,121	$	1,003	Inventories	$	1,186	$	1,003
Other assets	Other assets	87		148		Other assets	95		148

Inventories valued under the last in, first out ("LIFO") method	Inventories valued under the last in, first out ("LIFO") method	85		77		Inventories valued under the last in, first out ("LIFO") method	85		77


		Page No.
PART I	FINANCIAL INFORMATION	3
Item 1.	Financial Statements (unaudited)	3
	Condensed Consolidated Statements of Income	3
	Condensed Consolidated Statements of Comprehensive Income	4
	Condensed Consolidated Balance Sheets	5
	Condensed Consolidated Statements of Stockholders' Equity (Deficit)	6
	Condensed Consolidated Statements of Cash Flows	7
	Notes to Condensed Consolidated Financial Statements (unaudited)	8

















Item 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	22
Item 3.	Quantitative and Qualitative Disclosures about Market Risk	29
Item 4.	Controls and Procedures	29
PART II	OTHER INFORMATION	2930
Item 1.	Legal Proceedings	2930
Item 1A.	Risk Factors	2930
Item 5.	Other Information	30
Item 6.	Exhibits	3031
	Signatures


		Common Stock			Additional Paid-In Capital				Accumulated Deficit					Accumulated Other Comprehensive (Loss) Income				Total					Common Stock									Additional Paid-In Capital				Accumulated Deficit						Accumulated Other Comprehensive Loss					Total
		Shares	Par Value										Total			Shares					Par Value					Additional Paid-In Capital		Accumulated Deficit							Accumulated Other Comprehensive Loss
Balance at July 1, 2022																				Balance at July 1, 2022		254,321								$	3						$	—		$	(551)		$	(589)				$	(1,137)
Net income																					Net income		—				—					—				227						—					227
Other comprehensive loss, net of taxes																					Other comprehensive loss, net of taxes		—				—					—				—						(97)					(97)
Cash dividends declared on common stock ($0.28 per share)																					Cash dividends declared on common stock ($0.28 per share)		—				—					—				(74)						—					(74)
Stock-based compensation plans and other																					Stock-based compensation plans and other		43				—					—				15						—					15
Net transfers from Merck & Co., Inc., including Separation Adjustments																					Net transfers from Merck & Co., Inc., including Separation Adjustments		—				—					—				—						—					—
Balance at September 30, 2022																					Balance at September 30, 2022		254,364				$	3				$	—			$	(383)					$	(686)				$	(1,066)

Balance at July 1, 2023																					Balance at July 1, 2023		255,568				$	3				$	—			$	(25)					$	(533)				$	(555)
Net income																					Net income		—				—					—				58						—					58
Other comprehensive loss, net of taxes																					Other comprehensive loss, net of taxes		—				—					—				—						(43)					(43)
Cash dividends declared on common stock ($0.28 per share)																					Cash dividends declared on common stock ($0.28 per share)		—				—					—				(74)						—					(74)
Stock-based compensation plans and other																					Stock-based compensation plans and other		38				—					—				25						—					25

Balance at September 30, 2023																					Balance at September 30, 2023		255,606				$	3				$	—			$	(16)					$	(576)				$	(589)

Balance at January 1, 2022	Balance at January 1, 2022	253,550	$	3			$	—			$	(998)				$	(513)				$	(1,508)		Balance at January 1, 2022	253,550				$	3				$	—				$	(998)					$	(513)				$	(1,508)
Net income	Net income	—	—		—				348							—					348			Net income	—				—					—					809						—					809
Other comprehensive loss, net of taxes	Other comprehensive loss, net of taxes	—	—		—				—					(16)				(16)			Other comprehensive loss, net of taxes		—				—					—				—						(173)					(173)
Cash dividends declared on common stock ($0.28 per share)		—	—		—				(71)					—				(71)
Cash dividends declared on common stock ($0.84 per share)																					Cash dividends declared on common stock ($0.84 per share)		—				—					—				(218)						—					(218)
Stock-based compensation plans and other	Stock-based compensation plans and other	87	—		—				15					—				15			Stock-based compensation plans and other		814				—					—				41						—					41
Net transfers to Merck & Co., Inc. including Separation Adjustments	Net transfers to Merck & Co., Inc. including Separation Adjustments	—	—		—				(18)					—				(18)			Net transfers to Merck & Co., Inc. including Separation Adjustments		—				—					—				(17)						—					(17)
Balance at March 31, 2022		253,637	$	3	$	—			$	(724)				$	(529)			$	(1,250)
Balance at September 30, 2022																					Balance at September 30, 2022		254,364				$	3				$	—			$	(383)					$	(686)				$	(1,066)

Balance at January 1, 2023	Balance at January 1, 2023	254,370	$	3	$	—			$	(331)				$	(564)			$	(892)		Balance at January 1, 2023		254,370				$	3				$	—			$	(331)					$	(564)				$	(892)
Net income	Net income	—	—		—				177					—				177			Net income		—				—					—				477						—					477
Other comprehensive income, net of taxes		—	—		—				—					30				30
Cash dividends declared on common stock ($0.28 per share)		—	—		—				(73)					—				(73)
Other comprehensive loss, net of taxes																					Other comprehensive loss, net of taxes		—				—					—				—						(12)					(12)
Cash dividends declared on common stock ($0.84 per share)																					Cash dividends declared on common stock ($0.84 per share)		—				—					—				(221)						—					(221)
Stock-based compensation plans and other	Stock-based compensation plans and other	62	—						21					—				21			Stock-based compensation plans and other		1,236				—									59						—					59

Balance at March 31, 2023		254,432	$	3	$	—			$	(206)				$	(534)			$	(737)
Balance at September 30, 2023																					Balance at September 30, 2023		255,606				$	3				$	—			$	(16)					$	(576)				$	(589)


($ in millions)	($ in millions)	Fair Value Measurement Level	March 31, 2023		December 31, 2022		($ in millions)	Fair Value Measurement Level	September 30, 2023		December 31, 2022
Forward contracts in Other current assets	Forward contracts in Other current assets	2	$	12	$	6	Forward contracts in Other current assets	2	$	17	$	6
Forward contracts in Accrued and other current liabilities	Forward contracts in Accrued and other current liabilities	2	6		24		Forward contracts in Accrued and other current liabilities	2	12		24


($ in millions)	($ in millions)	Employee Benefit Plans		Cumulative Translation Adjustment		Accumulated Other Comprehensive Loss (Income)		($ in millions)	Employee Benefit Plans		Cumulative Translation Adjustment		Accumulated Other Comprehensive Loss
Balance at July 1, 2022, net of taxes								Balance at July 1, 2022, net of taxes	$	(13)	$	(576)	$	(589)
Other comprehensive loss, pretax								Other comprehensive loss, pretax	—		(97)		(97)
Tax								Tax	—		—		—
Other comprehensive loss, net of taxes								Other comprehensive loss, net of taxes	—		(97)		(97)

Balance at September 30, 2022, net of taxes								Balance at September 30, 2022, net of taxes	$	(13)	$	(673)	$	(686)

Balance at July 1, 2023, net of taxes								Balance at July 1, 2023, net of taxes	$	9	$	(542)	$	(533)
Other comprehensive loss, pretax								Other comprehensive loss, pretax	—		(43)		(43)
Tax								Tax	—		—		—
Other comprehensive loss, net of taxes								Other comprehensive loss, net of taxes	—		(43)		(43)
Balance at September 30, 2023, net of taxes								Balance at September 30, 2023, net of taxes	$	9	$	(585)	$	(576)

Balance at January 1, 2022, net of taxes	Balance at January 1, 2022, net of taxes	$	(13)	$	(500)	$	(513)	Balance at January 1, 2022, net of taxes	$	(13)	$	(500)	$	(513)
Other comprehensive loss, pretax	Other comprehensive loss, pretax	(1)		(15)		(16)		Other comprehensive loss, pretax	(1)		(173)		(174)
Tax	Tax	—		—		—		Tax	1		—		1
Other comprehensive loss, net of taxes	Other comprehensive loss, net of taxes	(1)		(15)		(16)		Other comprehensive loss, net of taxes	—		(173)		(173)

Balance at March 31, 2022, net of taxes		$	(14)	$	(515)	$	(529)
Balance at September 30, 2022, net of taxes								Balance at September 30, 2022, net of taxes	$	(13)	$	(673)	$	(686)

Balance at January 1, 2023, net of taxes	Balance at January 1, 2023, net of taxes	$	10	$	(574)	$	(564)	Balance at January 1, 2023, net of taxes	$	10	$	(574)	$	(564)
Other comprehensive income, pretax		—		30		30
Other comprehensive loss, pretax								Other comprehensive loss, pretax	(1)		(11)		(12)
Tax	Tax	—		—		—		Tax	—		—		—
Other comprehensive income, net of taxes		—		30		30
Other comprehensive loss, net of taxes								Other comprehensive loss, net of taxes	(1)		(11)		(12)

Balance at March 31, 2023, net of taxes		$	10	$	(544)	$	(534)
Balance at September 30, 2023, net of taxes								Balance at September 30, 2023, net of taxes	$	9	$	(585)	$	(576)


($ in millions)	($ in millions)			($ in millions)
2023	2023	$	6	2023	$	2
2024	2024	9		2024	9
2025	2025	9		2025	9
2026	2026	9		2026	9
2027	2027	9		2027	9
Thereafter	Thereafter	8,766		Thereafter	8,703