November 2, 2023 7:30 am EDT

JERSEY CITY, N.J.--(BUSINESS WIRE)-- Organon (NYSE: OGN) today announced its results for the third quarter ended September 30, 2023.

"Since spin, we have given new life to Established Brands and have expanded our pipeline in both Biosimilars and Women's Health," said Kevin Ali, Organon's CEO. "Year to date, all three of our franchises have delivered growth on a constant currency basis. Over the medium term, we expect to deliver mid-single digit revenue growth with the power of our existing portfolio. As we move into 2024, we will be working to reduce leverage and continue to add products that could enhance that growth profile."

Third Quarter 2023 Revenue

in $ millions		Q3 2023			Q3 2022			VPY			VPY ex-FX
Women’s Health		$	418		$	454		(8	)%		(7	)%
Biosimilars			142			129		10	%		10	%
Established Brands			935			915		2	%		3	%
Other (1)			24			39		(36	)%		(38	)%
Revenues		$	1,519		$	1,537		(1	)%		(1	)%
(1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties.

For the third quarter of 2023, total revenue was $1,519 million, a decrease of 1% on an as-reported basis as well as excluding impact of foreign currency (ex-FX), compared with the third quarter of 2022.

Women’s Health revenue decreased 8% on an as-reported basis, and decreased 7% ex-FX in the third quarter of 2023 compared with the third quarter of 2022 driven primarily by a 23% ex-FX decrease of NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) which continues to be impacted by generic competition. Together, the company's fertility products declined 10% ex-FX in the third quarter as unfavorable discount rates in the United States offset growth in demand. Nexplanon® (etonogestrel implant) decreased 3% ex-FX due unfavorable discount rates and a change in the go-to-market model for the product. These factors were partially offset by revenue from the Jada® system, which more than doubled year over year.

Biosimilars revenue increased 10% on an as-reported basis as well as ex-FX in the third quarter of 2023, compared with the third quarter of 2022. Renflexis® (infliximab-abda) grew 15% ex-FX in the third quarter due to continued demand and strong volume growth in United States and Canada. Ontruzant® (trastuzumab-dttb) grew 34% ex-FX in the third quarter compared to the prior year period driven by the phasing of a tender in Brazil.

Established Brands revenue increased 2% as-reported and increased 3% ex-FX in the third quarter of 2023, despite the impact of Volume Based Procurement (VBP) initiatives in China. Growth in the quarter was driven by Atozet™ (ezetimibe and atorvastatin calcium), particularly in France, strong demand for Nasonex® (mometasone) and favorable pricing for Dulera® (formoterol/fumarate dihydrate) in the United States. Year to date, the Established Brands franchise grew 1% ex-FX. The company expects the Established Brands franchise to achieve flat to slightly better revenue growth on a constant currency basis for the full year 2023.

Third Quarter 2023 Profitability

in $ millions, except per share amounts		Q3 2023			Q3 2022				VPY
Revenues		$	1,519		$	1,537			(1	)%
Cost of sales			612			551			11	%
Gross profit			907			986			(8	)%
Non-GAAP Adjusted gross profit (1)			951			1,032			(8	)%
Adjusted EBITDA (1,2)			447			546			(18	)%
Net income			58			227			(74	)%
Non-GAAP Adjusted net income (1)			223			337			(34	)%
Diluted Earnings per Share (EPS)			0.23			0.89			(74	)%
Non-GAAP Adjusted diluted EPS (1)			0.87			1.32			(34	)%
Acquired in-process research & development (IPR&D) and milestones			—			10			NM
Per share impact to diluted EPS from acquired IPR&D and milestones			—			(0.04	)		NM

		Q3 2023			Q3 2022
Gross margin		59.7	%		64.2	%
Non-GAAP Adjusted gross margin (1)		62.6	%		67.1	%
Adjusted EBITDA margin (1, 2)		29.4	%		35.5	%

(1)		See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures
(2)		Adjusted EBITDA and Adjusted EBITDA margin include $10 million in the third quarter of 2022 related to acquired IPR&D and milestones, no such expense was incurred in the third quarter of 2023

Gross margin was 59.7% as-reported and 62.6% on an adjusted basis in the third quarter of 2023 compared with 64.2% as-reported and 67.1% on an adjusted basis in the third quarter of 2022. The year-over-year decline in gross margin is primarily due to foreign exchange translation and inflationary manufacturing and distribution costs. Product mix and pricing erosion were also factors, but to a lesser extent.

EBITDA margin was 29.4% in the third quarter of 2023 compared with 35.5% in the third quarter of 2022 primarily due to lower Adjusted gross profit and to a lesser extent an increase in non-GAAP SG&A expense and loss on foreign exchange translation.

Net income for the third quarter of 2023 was $58 million, or $0.23 per diluted share, compared with $227 million, or $0.89 per diluted share, in the third quarter of 2022. Non-GAAP Adjusted net income was $223 million, or $0.87 per diluted share, compared with $337 million, or $1.32 per diluted share, in 2022. The year over year decrease in net income was a result of a lower Adjusted EBITDA, as well as higher interest expense.

Capital Allocation

Today, Organon’s 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 December 14, 2023, to stockholders of record at the close of business on November 13, 2023.

As of September 30, 2023, cash and cash equivalents were $414 million, and debt was $8.7 billion.

Full Year Guidance

Organon does not provide GAAP financial measures on a forward-looking basis because the company cannot predict with reasonable certainty and without unreasonable effort, the ultimate outcome of legal proceedings, unusual gains and losses, the occurrence of matters creating GAAP tax impacts, and acquisition-related expenses. These items are uncertain, depend on various factors, and could be material to Organon’s results computed in accordance with GAAP.

The company is updating its full year 2023 guidance ranges previously provided on August 8, 2023. The range for full year 2023 revenue is narrowed and lowered to $6.15 billion to $6.25 billion, which primarily reflects current foreign currency exchange rates, changes to the go-to-market model for Nexplanon, a slower uptake of Hadlima™ (adalimumab-bwwd) and macroeconomic factors in China.

The range for full year Adjusted EBITDA margin is now 30.5% to 31.5% to reflect a lower gross margin stemming from the impacts of foreign exchange on revenue, unfavorable product mix, and the timing of manufacturing costs. Organon's financial guidance does not assume an estimate for future IPR&D and milestone payments for business development transactions not yet executed.

Full year 2023 financial guidance is presented below on a non-GAAP basis.

	Previous guidance as of August 8, 2023	Current guidance
Revenues	$6.250B-$6.450B	$6.150B-$6.250B
Adjusted gross margin	Low-mid 60% range	Low 60% range
SG&A (as % of revenue)	Mid 20% range	Unchanged
R&D (as % of revenue)	Upper single-digit	Unchanged
Adjusted EBITDA margin	31.5%-33.0%	30.5%-31.5%
Interest	~$525 million	Unchanged
Depreciation	~$120 million	Unchanged
Effective non-GAAP tax rate	17.5%-19.5%	Unchanged
Fully diluted weighted average shares outstanding	~257 million	Unchanged

Webcast Information

Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its third quarter 2023 financial results. To listen to the event and view the presentation slides via webcast, join from the Organon Investor Relations website at https://www.organon.com/investor-relations/events-and-presentations/. A replay of the webcast will be available approximately two hours after the conclusion of the live event on the company’s website. Institutional investors and analysts interested in participating in the call must register in advance by clicking on this link: https://conferencingportals.com/event/VfCOQYEG

Following registration, participants will receive a confirmation email containing details on how to join the conference call, including dial-in information and a unique passcode and registrant ID. Pre-registration will allow participants to bypass an operator and be placed directly into the call.

About Organon

Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.

Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook.

Cautionary Note Regarding Non-GAAP Financial Measures

This press release contains “non-GAAP financial measures,” which are financial measures that either exclude or include amounts that are correspondingly not excluded or included in the most directly comparable measures calculated and presented in accordance with U.S. generally accepted accounting principles (“GAAP”). Specifically, the company makes use of the non-GAAP financial measures Adjusted EBITDA, Adjusted gross margin, Adjusted gross profit, Adjusted net income, and Adjusted diluted EPS, which are not recognized terms under GAAP and are presented only as a supplement to the company’s GAAP financial statements. This press release also provides certain measures that exclude the impact of foreign exchange. We calculate foreign exchange by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. The company believes that these non-GAAP financial measures help to enhance an understanding of the company’s financial performance. However, the presentation of these measures has limitations as an analytical tool and should not be considered in isolation, or as a substitute for the company’s results as reported under GAAP. Because not all companies use identical calculations, the presentations of these non-GAAP measures may not be comparable to other similarly titled measures of other companies. You should refer to Table 4 and Table 5 of this press release for relevant definitions and reconciliations of non-GAAP financial measures contained herein to the most directly comparable GAAP measures.

In addition, the company’s full-year 2023 guidance measures (other than revenue) are provided on a non-GAAP basis because the company is unable to reasonably predict certain items contained in the GAAP measures. Such items include, but are not limited to, acquisition related expenses, restructuring and related expenses, stock-based compensation, the ultimate outcome of legal proceedings, unusual gains and losses, the occurrence of matters creating GAAP tax impacts and other items not reflective of the company's ongoing operations.

The company uses non-GAAP financial measures in its operational and financial decision making, and believes that it is useful to exclude certain items in order to focus on what it regards to be a more meaningful representation of the underlying operating performance of the business.

Cautionary Note Regarding Forward-Looking Statements

Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about management’s expectations about Organon’s future financial performance and prospects, including full-year 2023 guidance estimates and predictions regarding other financial information and metrics, franchise and product performance and strategy expectations for the remainder of 2023 and for future periods, expectations regarding the impact of VBP and developments in China. Forward-looking statements may be identified by words such as "foresees" “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include, but are not limited to, an inability to fully execute on our product development and commercialization plans within the United States or 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; an inability to execute on our business development strategy or realize the benefits of our planned acquisitions; efficacy, safety, or other quality concerns with respect to marketed products, including market actions such as recalls, withdrawals, or declining sales; political and social pressures, or regulatory developments, that adversely impact demand for, availability of, or patient access to contraception or fertility products; general economic factors, including recessionary pressures, interest rate and currency exchange rate fluctuations; general industry conditions and competition; the impact of the ongoing COVID-19 pandemic and emergence of variant strains; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances; new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict its future financial results and performance; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; difficulties developing and sustaining relationships with commercial counterparties; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the Securities and Exchange Commission ("SEC"), including the company’s Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov).

TABLE 1

Organon & Co. Condensed Consolidated Statement of Income (Unaudited, $ in millions except shares in thousands and per share amounts)
	Three Months Ended September 30,								Nine Months Ended September 30,
		2023				2022				2023				2022
Revenues	$	1,519			$	1,537			$	4,665			$	4,689
Costs, Expenses and Other
Cost of sales		612				551				1,832				1,700
Selling, general and administrative		538				440				1,424				1,234
Research and development		137				127				394				329
Acquired in-process research and development and milestones		—				10				8				107
Restructuring costs		—				11				4				11
Interest expense		134				108				398				303
Exchange losses (gains)		14				4				25				(21	)
Other expense, net		4				4				11				15
		1,439				1,255				4,096				3,678
Income Before Income Taxes		80				282				569				1,011
Taxes on income		22				55				92				202
Net Income		58				227				477				809
Earnings per Share:
Basic	$	0.23			$	0.89			$	1.87			$	3.19
Diluted	$	0.23			$	0.89			$	1.86			$	3.17
Weighted Average Shares Outstanding:
Basic		255,588				254,348				255,112				253,986
Diluted		256,349				255,067				256,162				255,094

TABLE 2

Organon & Co. Sales by top products (Unaudited, $ in millions)
	Three Months Ended September 30,																		Nine Months Ended September 30,
	2023									2022									2023										2022
	U.S.			Int’l			Total			U.S.			Int’l			Total			U.S.				Int’l			Total			U.S.			Int’l			Total
Women’s Health
Nexplanon/Implanon NXT	$	146		$	74		$	220		$	151		$	78		$	229		$	418			$	181		$	599		$	401		$	194		$	595
Follistim AQ		22			32			54			27			33			60			74				105			179			79			100			179
NuvaRing		18			20			37			27			23			50			50				67			117			65			68			133
Ganirelix Acetate Injection		4			21			25			6			30			36			15				74			88			20			77			97
Marvelon/Mercilon		—			30			30			—			31			31			—				97			97			—			85			85
Jada		12			—			13			5			—			5			30				—			31			12			—			12
Other Women's Health (1)		16			22			39			19			23			42			52				74			126			68			70			138
Biosimilars
Renflexis		57			12			69			54			7			60			172				29			201			145			20			166
Ontruzant		11			28			40			15			14			29			36				57			93			35			52			87
Brenzys		—			13			13			—			24			24			—				45			45			—			52			52
Aybintio		—			12			12			—			10			10			—				34			34			—			29			29
Hadlima		2			6			8			—			6			6			2				18			20			—			14			14
Established Brands
Cardiovascular
Zetia		2			65			66			2			85			87			5				234			239			7			280			287
Vytorin		2			31			33			1			30			31			5				95			100			6			98			104
Atozet		—			126			126			—			109			109			—				397			397			—			350			350
Rosuzet		—			17			17			—			17			17			—				52			52			—			55			55
Cozaar/Hyzaar		3			65			68			2			68			70			8				217			225			11			244			256
Other Cardiovascular(1)		1			42			44			1			34			35			2				124			126			3			117			120
Respiratory
Singulair		3			88			91			3			92			94			8				282			290			8			308			316
Nasonex		—			54			55			—			49			49			—				187			188			9			173			182
Dulera		40			9			49			31			9			40			116				28			144			98			30			127
Clarinex		2			26			28			—			25			26			4				103			107			3			96			99
Other Respiratory(1)		17			9			25			11			10			21			42				20			61			34			32			66
Non-Opioid Pain, Bone and
Arcoxia		—			64			64			—			64			64			—				207			207			—			185			185
Fosamax		1			40			41			1			35			36			2				121			123			2			115			117
Diprospan		—			31			31			—			28			28			—				58			58			—			91			91
Other Non-Opioid Pain, Bone and Dermatology(1)		4			70			74			2			63			65			11				196			207			10			200			210
Other
Proscar		—			25			25			—			26			27			1				76			77			1			76			77
Propecia		2			21			22			2			28			30			5				86			92			5			90			95
Other(1)		5			72			76			6			81			87			10				231			240			21			230			251
Other (2)		—			24			24			—			39			39			(1	)			103			102			—			115			116
Revenues	$	370		$	1,149		$	1,519		$	366		$	1,171		$	1,537		$	1,067			$	3,598		$	4,665		$	1,043		$	3,646		$	4,689

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 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)		Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties.

TABLE 3

Organon & Co. Sales by geographic area (Unaudited, $ in millions)
	Three Months Ended September 30,								Nine Months Ended September 30,
		2023				2022				2023				2022
Europe and Canada	$	392			$	363			$	1,259			$	1,243
United States		370				366				1,067				1,043
Asia Pacific and Japan		284				283				869				888
China		202				241				661				721
Latin America, Middle East, Russia, and Africa		239				236				687				665
Other (1)		32				48				122				129
Revenues	$	1,519			$	1,537			$	4,665			$	4,689
(1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties.

TABLE 4

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited, $ in millions except per share amounts)
	Three Months Ended September 30, 2023
	GAAP				Spin related Costs(1)			Restructuring		Stock-based Compensation			Amortization			Other(1)			Non-GAAP Adjusted
Revenues	$	1,519																	$	1,519
Cost of sales		612			(10	)		—		(5	)		(29	)		—				568
Gross profit		907																		951
Gross margin		59.7	%																	62.6	%
Selling, general and administrative		538			(41	)		—		(18	)		—			(87	)			392
Research and development		137			(4	)		—		(4	)		—			—				129
Acquired in-process research and development and milestones		—			—			—		—			—			—				—
Restructuring costs		—			—			—		—			—			—				—
Interest expense		134			—			—		—			—			—				134
Exchange losses		14			—			—		—			—			—				14
Other expense (income), net		4			(3	)		—		—			—			—				1
		1,439																		1,238
Income before income taxes		80																		281
Taxes on income		22			16			—		4			5			11				58
Net income	$	58																	$	223
Earnings per share - Diluted	$	0.23																	$	0.87
(1) Represents one-time costs. Spin-related includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US and Other primarily includes inventory step-up amortization, impairment charges and legal reserves.

	Three Months Ended September 30, 2022
	GAAP				Spin related Costs(1)			Restructuring			Stock-based Compensation			Amortization			Other(1)			Non-GAAP Adjusted
Revenues	$	1,537																		$	1,537
Cost of sales		551			(8	)		—			(3	)		(32	)		(3	)			505
Gross profit		986																			1,032
Gross margin		64.2	%																		67.1	%
Selling, general and administrative		440			(33	)		—			(12	)		—			(17	)			378
Research and development		127			(2	)		—			(3	)		—			(1	)			121
Acquired in-process research and development and		10			—			—			—			—			—				10
Restructuring costs		11			—			(11	)		—			—			—				—
Interest expense		108			—			—			—			—			—				108
Exchange gains		4			—			—			—			—			—				4
Other expense (income), net		4			(6	)		—			—			—			—				(2	)
		1,255																			1,124
Income before income taxes		282																			413
Taxes on income		55			10			2			2			6			1				76
Net income	$	227																		$	337
Earnings per share - Diluted	$	0.89																		$	1.32
(1) Represents one-time costs. Spin-related includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US and Other primarily includes inventory step-up amortization, impairment charges and legal reserves.

TABLE 4 (Continued)

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited, $ in millions except per share amounts)
	Nine Months Ended September 30, 2023
	GAAP				Spin related Costs(1)			Restructuring			Stock-based Compensation			Amortization			Other(1)			Non-GAAP Adjusted
Revenues	$	4,665																		$	4,665
Cost of sales		1,832			(30	)		—			(13	)		(88	)		(2	)			1,699
Gross profit		2,833																			2,966
Gross margin		60.7	%																		63.6	%
Selling, general and administrative		1,424			(131	)		—			(50	)		—			(88	)			1,155
Research and development		394			(10	)		—			(11	)		—			—				373
Acquired in-process research and development and milestones		8			—			—			—			—			—				8
Restructuring costs		4			—			(4	)		—			—			—				—
Interest expense		398			—			—			—			—			—				398
Exchange losses		25			—			—			—			—			—				25
Other expense (income), net		11			(13	)		—			—			—			—				(2	)
		4,096																			3,656
Income before income taxes		569																			1,009
Taxes on income		92			42			1			12			16			11				174
Net income	$	477																		$	835
Earnings per share - Diluted	$	1.86																		$	3.26
(1) Represents one-time costs. Spin-related includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US and Other primarily includes inventory step-up amortization, impairment charges and legal reserves.

	Nine Months Ended September 30, 2022
	GAAP				Spin related Costs(1)			Restructuring			Stock-based Compensation			Amortization			Other(1)			Non-GAAP Adjusted
Revenues	$	4,689																		$	4,689
Cost of sales		1,700			(18	)		—			(9	)		(88	)		(17	)			1,568
Gross profit		2,989																			3,121
Gross margin		63.7	%																		66.6	%
Selling, general and administrative		1,234			(86	)		—			(35	)		—			(17	)			1,096
Research and development		329			(8	)		—			(8	)		—			(2	)			311
Acquired in-process research and development and		107			—			—			—			—			—				107
Restructuring costs		11			—			(11	)		—			—			—				—
Interest expense		303			—			—			—			—			—				303
Exchange gains		(21	)		—			—			—			—			—				(21	)
Other expense (income), net		15			(20	)		—			—			—			—				(5	)
		3,678																			3,359
Income before income taxes		1,011																			1,330
Taxes on income		202			24			2			7			15			4				254
Net income	$	809																		$	1,076
Earnings per share - Diluted	$	3.17																		$	4.22
(1) Represents one-time costs. Spin-related includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US and Other primarily includes inventory step-up amortization, impairment charges and legal reserves.

TABLE 5

Organon & Co. Reconciliation of GAAP Income Before Income Taxes to Adjusted EBITDA (Unaudited, $ in millions)
	Three Months Ended September 30,								Nine Months Ended September 30,
		2023				2022				2023				2022
Income before income taxes	$	80			$	282			$	569			$	1,011
Depreciation		32				25				88				72
Amortization		29				32				88				88
Interest expense		134				108				398				303
EBITDA	$	275			$	447			$	1,143			$	1,474
Restructuring costs		—				11				4				11
One-time costs (1)		145				70				274				168
Stock-based compensation		27				18				74				52
Adjusted EBITDA	$	447			$	546			$	1,495			$	1,705
Adjusted EBITDA margin		29.4	%			35.5	%			32.0	%			36.4	%
(1) One-time costs primarily include costs incurred in connection with the spin-off of Organon, inventory step up adjustments, impairment charges and legal reserves.

 

Source: Organon & Co.