Organon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2023

  • Full year 2023 revenue of $6.3 billion, up 1% as-reported and 3% at constant currency
  • Full year 2023 diluted earnings per share of $3.99 and non-GAAP Adjusted diluted earnings per share of $4.14
  • Full year 2023 Adjusted EBITDA of $1.9 billion, representing a 31.0% Adjusted EBITDA margin
  • Full year 2024 financial guidance ranges provided; full year revenue range of $6.2 billion to $6.5 billion and Adjusted EBITDA margin in the range of 31.0% to 33.0%

JERSEY CITY, N.J.--(BUSINESS WIRE)-- Organon (NYSE: OGN) today announced its results for the fourth quarter and full year ended December 31, 2023.

"As we move into 2024, our priorities are to deliver our third year of constant currency revenue growth and to achieve a stable to improving Adjusted EBITDA margin. Delivering this financial profile is key for us to be able to continue advancing on our mission of a healthier every day for every woman. There’s a tremendous opportunity in women’s health to address significant unmet needs and we are well positioned at the forefront of that effort."

Fourth Quarter 2023 Revenue

in $ millions

Q4 2023

 

Q4 2022

 

VPY

 

VPY ex-FX

Women’s Health

$

465

 

$

433

 

7

%

 

8

%

Biosimilars

 

199

   

134

 

49

%

 

48

%

Established Brands

 

915

   

888

 

3

%

 

3

%

Other (1)

 

19

   

30

 

(37

)%

 

(42

)%

Revenues

$

1,598

 

$

1,485

 

8

%

 

8

%

(1)

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

For the fourth quarter of 2023, total revenue was $1,598 million, an increase of 8% on an as-reported basis as well as excluding impact of foreign currency (ex-FX), compared with the fourth quarter of 2022.

Women’s Health revenue increased 7% on an as-reported basis, and increased 8% ex-FX in the fourth quarter of 2023 compared with the fourth quarter of 2022 driven primarily by strong growth in the company's fertility products, particularly Follistim AQ® (follitropin beta injection). Follistim grew 63% ex-FX in the fourth quarter due to a one-time buy-in as a result of the exit of the Interim Operating Model ("IOM") in the United States, increased demand in the U.S. that was largely tied to onboarding a new customer, as well as volume recovery in China tied to fertility patients returning to clinics following abating COVID-19 concerns. The Women's Health franchise also benefited from strong performance of oral contraceptives Marvelon™ (ethinylestradiol, desogestrel) and Mercilon™ (ethinylestradiol, desogestrel) which was driven in part by the reacquisition of rights in selected territories in Southeast Asia and China during 2022, as well as continued uptake of the Jada® system. Performance was partially offset by a 3% ex-FX decline in Nexplanon® (etonogestrel implant) primarily related to customer buying patterns associated with the company's decision to forgo its normal Nexplanon list-price increase in 2023, as well as a 12% ex-FX decrease in NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) which continues to be impacted by generic competition.

Biosimilars revenue increased 49% on an as-reported basis and increased 48% ex-FX in the fourth quarter of 2023, compared with the fourth quarter of 2022 primarily driven by Ontruzant® (trastuzumab-dttb), which grew 76% ex-FX and benefited from favorable timing of tender phasing in Brazil, and Renflexis® (infliximab-abda), which grew 28% ex-FX primarily due to U.S. strong volume growth. Revenue of Hadlima™ (adalimumab-bwwd) more than doubled in the fourth quarter of 2023 compared with the fourth quarter of 2022 as a result of continued uptake since its July 2023 launch in the U.S.

Established Brands revenue increased 3% as-reported and 3% ex-FX in the fourth quarter of 2023 despite the impacts of Volume Based Procurement (VBP) initiatives and a challenging operating environment in China. Growth in the quarter was driven by a 13% ex-FX increase in the respiratory portfolio. In the cardiovascular portfolio, continued growth in Atozet™ (ezetimibe and atorvastatin calcium) partially offset a decline in Cozaar®/Hyzaar® (losartan) products which are subject to ongoing generic competition.

Fourth Quarter 2023 Profitability

in $ millions, except per share amounts

 

Q4 2023

 

Q4 2022

 

VPY

Revenues

 

$

1,598

 

$

1,485

 

8

%

Cost of sales

   

683

   

594

 

15

%

Gross profit

   

915

   

891

 

3

%

Non-GAAP Adjusted gross profit (1)

   

964

   

937

 

3

%

Adjusted EBITDA (1,2)

   

449

   

380

 

18

%

Net income

   

546

   

108

 

406

%

Non-GAAP Adjusted net income (1)

   

226

   

208

 

9

%

Diluted Earnings per Share (EPS)

   

2.13

   

0.42

 

407

%

Non-GAAP Adjusted diluted EPS (1)

   

0.88

   

0.81

 

9

%

Acquired in-process research & development (IPR&D) and milestones

   

   

 

 

Per share impact to diluted EPS from acquired IPR&D and milestones

   

   

 

 
   

Q4 2023

 

Q4 2022

   

Gross margin

 

57.3

%

 

60.0

%

   

Non-GAAP Adjusted gross margin (1)

 

60.3

%

 

63.1

%

   

Adjusted EBITDA margin (1, 2)

 

28.1

%

 

25.6

%

   

(1)

See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures

(2)

Adjusted EBITDA and Adjusted EBITDA margin include no acquired IPR&D in the fourth quarter 2022 nor the fourth quarter 2023

Gross margin was 57.3% as-reported and 60.3% on an adjusted basis in the fourth quarter of 2023 compared with 60.0% as-reported and 63.1% on an adjusted basis in the fourth quarter of 2022. Unfavorable foreign exchange translation and to a lesser extent, product mix more than offset a favorable year-over-year comparison to the fourth quarter 2022 when the company took a market action on certain injectable steroid products.

Adjusted EBITDA margin was 28.1% in the fourth quarter of 2023 compared with 25.6% in the fourth quarter of 2022 primarily due to lower year-over-year operating expenses and lower loss on foreign exchange translation attributable to the year-over-year comparison of the amount of the company's Euro-denominated debt covered under a net investment hedge program.

Net income for the fourth quarter of 2023 was $546 million, or $2.13 per diluted share, compared with $108 million, or $0.42 per diluted share, in the fourth quarter of 2022. Non-GAAP Adjusted net income was $226 million, or $0.88 per diluted share, compared with $208 million, or $0.81 per diluted share, in 2022. Reported GAAP net income for the fourth quarter includes a net $476 million tax benefit resulting from the termination of a Swiss tax arrangement.

Revenues

in $ millions

 

FY 2023

 

FY 2022

 

VPY

 

VPY ex-FX

Women’s Health

 

$

1,702

 

$

1,673

 

2

%

 

3

%

Biosimilars

   

593

   

481

 

23

%

 

24

%

Established Brands

   

3,847

   

3,874

 

(1

)%

 

2

%

Other(1)

   

121

   

146

 

(17

)%

 

(19

)%

Revenue

 

$

6,263

 

$

6,174

 

1

%

 

3

%

(1)

Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA.

Total revenue was $6.3 billion for full year 2023, an increase of 1% as-reported and an increase of 3% ex-FX, compared with the full year 2022.

Women’s Health revenue increased 2% as-reported and 3% ex-FX for full year 2023 compared with 2022. Strong growth in the company's fertility portfolio, which was up 9% ex-FX for the full year, a 24% ex-FX increase in oral contraceptives Marvelon/Mercilon and continued uptake of the Jada System, were the strongest revenue contributors to the Women’s Health franchise in 2023. Together these factors more than offset an 11% ex-FX decline in NuvaRing, which continues to be impacted by generic competition. Modest growth of Nexplanon of 1% ex-FX for the full year reflects the impact of the limited participation of a tender in Mexico and customer buying patterns associated with the company's decision to forgo its normal list price increase for Nexplanon in 2023.

Biosimilars revenue increased 23% as-reported and 24% ex-FX for full year 2023 compared with 2022, driven primarily by continued demand growth in the U.S. and Canada for Renflexis and favorable phasing of tenders in Brazil and increased demand for Ontruzant, partially offset by competitive pressures in Europe.

Revenue for Established Brands declined 1% as-reported and increased 2% ex-FX for the full year 2023 despite VBP initiatives and a challenging operating environment in China as well as supply interruptions of certain of the company's injectable steroid products stemming from the market action taken earlier in the year. Performance was driven by 2% growth in volume across the portfolio, partially offset by 1% price pressure. The company expects flat performance in the Established Brands franchise for full year 2024 on an ex-FX basis.

Full Year 2023 Profitability

in $ millions, except per share amounts

   

2023

     

2022

   

VPY

Revenues

 

$

6,263

   

$

6,174

   

1

%

Cost of sales

   

2,515

     

2,294

   

10

%

Gross profit

   

3,748

     

3,880

   

(3

)%

Non-GAAP Adjusted gross profit (1)

   

3,930

     

4,058

   

(3

)%

Adjusted EBITDA (1,2)

   

1,944

     

2,085

   

(7

)%

Net income

   

1,023

     

917

   

12

%

Non-GAAP Adjusted net income (1)

   

1,061

     

1,284

   

(17

)%

Diluted Earnings per Share (EPS)

   

3.99

     

3.59

   

11

%

Non-GAAP Adjusted diluted EPS (1)

   

4.14

     

5.03

   

(18

)%

Acquired in-process research & development (IPR&D) and milestones

   

8

     

107

   

(93

)%

Per share impact to diluted EPS from acquired IPR&D and milestones

   

(0.03

)

   

(0.33

)

 

(91

)%

   

2023

 

2022

   

Gross margin

 

59.8

%

 

62.8

%

   

Non-GAAP Adjusted gross margin (1)

 

62.7

%

 

65.7

%

   

Adjusted EBITDA margin (1, 2)

 

31.0

%

 

33.8

%

   

(1)

See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures

(2)

Adjusted EBITDA and Adjusted EBITDA margin include $8 million in 2023 and $107 million in 2022 related to acquired IPR&D and milestones

Gross margin was 59.8% as-reported and 62.7% on an adjusted basis for full year 2023 compared with 62.8% as-reported and 65.7% on an adjusted basis for full year 2022. The year-over-year decrease in Adjusted gross margin reflects higher cost of sales due to foreign exchange translation and product mix, and to a lesser extent, higher employee-related and distribution-related costs.

Adjusted EBITDA margin was 31.0% for the full year 2023 compared with 33.8% for the full year 2022. The year-over-year decrease was primarily a result of a lower Adjusted gross margin. Higher selling and promotional costs were mostly offset by lower total research and development spend, which includes in-process research and development (IPR&D).

Net income for 2023 was $1.0 billion, or $3.99 per diluted share, compared with $917 million, or $3.59 per diluted share in 2022. Non-GAAP Adjusted net income was $1.1 billion or $4.14 per diluted share, compared with $1.3 billion, or $5.03 per diluted share in 2022. The year-over-year decline in net income was primarily due to higher interest expense due to increased interest rates, and accelerated amortization of capitalized financing costs associated with voluntary prepayments on the company’s U.S. dollar-denominated term loan.

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 March 14, 2024, to stockholders of record at the close of business on February 26, 2024.

As of December 31, 2023, cash and cash equivalents were $693 million, and debt was $8.8 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.

Full year 2024 financial guidance is presented below on a non-GAAP basis. For full year 2024, Organon expects constant currency revenue growth in the low-single-digit range and expects stable to improving Adjusted EBITDA margin, which Organon expects to achieve, in part, through operating expense management.

 

2024 Full Year Guidance

Revenues

$6.2B-$6.5B

Adjusted gross margin

61.0% - 63.0%

SG&A

$1.5B - $1.7B

R&D (excluding IPR&D)

$400M - $500M

Adjusted EBITDA margin

31.0% - 33.0%

Interest

~$520M

Depreciation

~$130M

Effective non-GAAP tax rate

18.5% - 20.5%

Fully diluted weighted average shares outstanding

~259M

Webcast Information

Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its fourth quarter and full year 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 2024 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 2024 guidance estimates and predictions regarding other financial information and metrics, and franchise and product performance and strategy expectations for future periods. 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 that 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 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; the impact of higher selling and promotional costs; any failure by Organon to obtain an additional period of market exclusivity in the United States for Nexplanon subsequent to the expiration of certain key patents in 2027; 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 most recent Annual Report on Form 10-K 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
December 31,

 

Year Ended
December 31,

   

2023

     

2022

   

2023

     

2022

Revenues

$

1,598

   

$

1,485

 

$

6,263

   

$

6,174

Costs, Expenses and Other

             

Cost of sales

 

683

     

594

   

2,515

     

2,294

Selling, general and administrative

 

469

     

470

   

1,893

     

1,704

Research and development

 

134

     

142

   

528

     

471

Acquired in-process research and development and milestones

 

     

   

8

     

107

Restructuring costs

 

58

     

17

   

62

     

28

Interest expense

 

129

     

119

   

527

     

422

Exchange losses

 

17

     

32

   

42

     

11

Other expense, net

 

4

     

   

15

     

15

   

1,494

     

1,374

   

5,590

     

5,052

Income Before Income Taxes

 

104

     

111

   

673

     

1,122

Taxes on income

 

(442

)

   

3

   

(350

)

   

205

Net Income

 

546

     

108

   

1,023

     

917

               

Earnings per Share:

             

Basic

$

2.14

   

$

0.42

 

$

4.01

   

$

3.61

Diluted

$

2.13

   

$

0.42

 

$

3.99

   

$

3.59

               

Weighted Average Shares Outstanding:

             

Basic

 

255,617

     

254,367

   

255,239

     

254,082

Diluted

 

256,590

     

255,390

   

256,270

     

255,169

TABLE 2

Organon & Co.

Sales by top products

(Unaudited, $ in millions)

       
 

Three Months Ended December 31,

 

Year Ended December 31,

 

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

$

154

 

$

76

 

$

231

 

$

172

   

$

67

 

$

239

 

$

572

   

$

257

 

$

830

 

$

573

 

$

261

 

$

834

Follistim AQ

 

51

   

31

   

83

   

26

     

25

   

50

   

125

     

136

   

262

   

105

   

124

   

229

NuvaRing

 

16

   

19

   

35

   

21

     

20

   

40

   

66

     

86

   

152

   

85

   

88

   

173

Ganirelix Acetate Injection

 

4

   

18

   

22

   

6

     

20

   

25

   

19

     

91

   

110

   

26

   

97

   

123

Marvelon/Mercilon

 

   

37

   

37

   

     

24

   

24

   

     

134

   

134

   

   

110

   

110

Jada

 

13

   

   

13

   

8

     

   

8

   

43

     

   

43

   

20

   

   

20

Other Women's Health (1)

 

20

   

26

   

44

   

22

     

24

   

46

   

72

     

101

   

171

   

90

   

94

   

184

Biosimilars

                                             

Renflexis

 

63

   

14

   

77

   

51

     

9

   

60

   

234

     

43

   

278

   

196

   

30

   

226

Ontruzant

 

10

   

52

   

62

   

13

     

22

   

35

   

46

     

109

   

155

   

48

   

74

   

122

Brenzys

 

   

28

   

28

   

     

23

   

23

   

     

73

   

73

   

   

75

   

75

Aybintio

 

   

9

   

9

   

     

10

   

10

   

     

43

   

43

   

   

39

   

39

Hadlima

 

15

   

8

   

23

   

     

6

   

6

   

17

     

26

   

44

   

   

19

   

19

Established Brands

                                             

Cardiovascular

                                             

Zetia

 

3

   

65

   

67

   

1

     

70

   

71

   

8

     

299

   

306

   

8

   

350

   

357

Vytorin

 

1

   

28

   

29

   

1

     

25

   

26

   

6

     

124

   

129

   

8

   

123

   

130

Atozet

 

   

122

   

122

   

     

107

   

107

   

     

519

   

519

   

   

457

   

457

Rosuzet

 

   

18

   

18

   

     

16

   

16

   

     

70

   

70

   

   

71

   

71

Cozaar/Hyzaar

 

2

   

55

   

57

   

2

     

66

   

68

   

10

     

272

   

281

   

13

   

310

   

323

Other Cardiovascular (1)

 

   

28

   

29

   

1

     

39

   

40

   

2

     

151

   

155

   

3

   

156

   

159

Respiratory

                                             

Singulair

 

2

   

111

   

114

   

3

     

92

   

95

   

11

     

393

   

404

   

11

   

400

   

411

Nasonex

 

   

65

   

65

   

     

56

   

56

   

     

252

   

253

   

10

   

229

   

238

Dulera

 

40

   

10

   

50

   

42

     

10

   

52

   

156

     

38

   

194

   

140

   

40

   

180

Clarinex

 

1

   

29

   

30

   

2

     

25

   

27

   

5

     

132

   

136

   

4

   

121

   

125

Other Respiratory (1)

 

8

   

8

   

15

   

12

     

5

   

17

   

49

     

28

   

77

   

46

   

36

   

83

Non-Opioid Pain, Bone and

                                             

Arcoxia

 

   

51

   

51

   

     

56

   

56

   

     

257

   

257

   

   

241

   

241

Fosamax

 

   

35

   

36

   

2

     

34

   

36

   

3

     

156

   

159

   

4

   

148

   

152

Diprospan

 

   

33

   

33

   

     

31

   

31

   

     

91

   

91

   

   

122

   

122

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

 

4

   

64

   

67

   

5

     

56

   

62

   

14

     

261

   

275

   

15

   

257

   

273

Other

                                             

Proscar

 

   

20

   

20

   

     

23

   

24

   

1

     

96

   

97

   

1

   

99

   

101

Propecia

 

2

   

31

   

33

   

2

     

28

   

30

   

7

     

118

   

125

   

7

   

118

   

125

Other (1)

 

1

   

78

   

79

   

3

     

72

   

75

   

13

     

308

   

319

   

24

   

302

   

326

Other (2)

 

1

   

18

   

19

   

(1

)

   

30

   

30

   

(1

)

   

121

   

121

   

   

146

   

146

Revenues

$

411

 

$

1,187

 

$

1,598

 

$

394

   

$

1,091

 

$

1,485

 

$

1,478

   

$

4,785

 

$

6,263

 

$

1,437

 

$

4,737

 

$

6,174

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 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

December 31,

 

Year Ended

December 31,

   

2023

   

2022

   

2023

   

2022

Europe and Canada

$

414

 

$

389

 

$

1,673

 

$

1,631

United States

 

411

   

394

   

1,478

   

1,437

Asia Pacific and Japan

 

261

   

256

   

1,129

   

1,143

China

 

203

   

196

   

864

   

917

Latin America, Middle East, Russia, and Africa

 

279

   

230

   

965

   

895

Other (1)

 

30

   

20

   

154

   

151

Revenues

$

1,598

 

$

1,485

 

$

6,263

 

$

6,174

(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 December 31, 2023

 

GAAP

 

Spin related Costs(1)

 

Restructuring

 

Stock-based Compensation

 

Amortization

 

Other(2)

 

Non-GAAP Adjusted

Revenues

$

1,598

                       

$

1,598

 

Cost of sales

 

683

   

(17

)

 

   

(4

)

 

(28

)

 

     

634

 

Gross profit

 

915

                         

964

 

Gross margin

 

57.3

%

                       

60.3

%

                           

Selling, general and administrative

 

469

   

(47

)

 

   

(18

)

 

   

(3

)

   

401

 

Research and development

 

134

   

(2

)

 

   

(5

)

 

   

     

127

 

Acquired in-process research and development and milestones

 

   

   

   

   

   

     

 

Restructuring costs

 

58

   

   

(58

)

 

   

   

     

 

Interest expense

 

129

   

   

   

   

   

     

129

 

Exchange losses

 

17

   

   

   

   

   

     

17

 

Other expense (income), net

 

4

   

(4

)

 

   

   

   

     

 
   

1,494

                         

1,308

 

Income before income taxes

 

104

                         

290

 

Taxes on income

 

(442

)

 

7

   

12

   

5

   

5

   

477

     

64

 

Net income

$

546

                       

$

226

 
                           

Earnings per share - Diluted

$

2.13

                       

$

0.88

 

(1)

One-time spin-related costs includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US.

(2)

Other costs primarily includes a tax benefit resulting from the termination of a Swiss tax arrangement and one-time costs related to inventory step-up adjustments and legal reserves.
   
 

Three Months Ended December 31, 2022

 

GAAP

 

Spin related Costs(1)

 

Restructuring

 

Stock-based Compensation

 

Amortization

 

Other(2)

 

Non-GAAP Adjusted

Revenues

$

1,485

                       

$

1,485

 

Cost of sales

 

594

   

(7

)

 

   

(4

)

 

(28

)

 

(7

)

   

548

 

Gross profit

 

891

                         

937

 

Gross margin

 

60.0

%

                       

63.1

%

                           

Selling, general and administrative

 

470

   

(36

)

 

   

(16

)

 

   

(4

)

   

414

 

Research and development

 

142

   

(3

)

 

   

(3

)

 

   

(1

)

   

135

 

Acquired in-process research and development and milestones

 

   

   

   

   

   

     

 

Restructuring costs

 

17

   

   

(17

)

 

   

   

     

 

Interest expense

 

119

   

   

   

   

   

     

119

 

Exchange losses

 

32

   

   

   

   

   

     

32

 

Other expense (income), net

 

   

(3

)

 

   

   

   

3

     

 
   

1,374

                         

1,248

 

Income before income taxes

 

111

                         

237

 

Taxes on income

 

3

   

12

   

4

   

6

   

4

   

     

29

 

Net income

$

108

                       

$

208

 
                           

Earnings per share - Diluted

$

0.42

                       

$

0.81

 

(1)

One-time spin-related costs includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US.

(2)

Other costs primarily includes one-time costs related to inventory step-up adjustments and legal reserves.

TABLE 4 (continued)

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

(Unaudited, $ in millions except per share amounts)

   
 

Year Ended December 31, 2023

 

GAAP

 

Spin related Costs(1)

 

Restructuring

 

Stock-based Compensation

 

Amortization

 

Other(2)

 

Non-GAAP Adjusted

Revenues

$

6,263

                       

$

6,263

 

Cost of sales

 

2,515

   

(47

)

 

   

(17

)

 

(116

)

 

(2

)

   

2,333

 

Gross profit

 

3,748

                         

3,930

 

Gross margin

 

59.8

%

                       

62.7

%

                           

Selling, general and administrative

 

1,893

   

(178

)

 

   

(68

)

 

   

(91

)

   

1,556

 

Research and development

 

528

   

(12

)

 

   

(16

)

 

   

     

500

 

Acquired in-process research and development and milestones

 

8

   

   

   

   

   

     

8

 

Restructuring costs

 

62

   

   

(62

)

 

   

   

     

 

Interest expense

 

527

   

   

   

   

   

     

527

 

Exchange losses

 

42

   

   

   

   

   

     

42

 

Other expense (income), net

 

15

   

(17

)

 

   

   

   

     

(2

)

   

5,590

                         

4,964

 

Income before income taxes

 

673

                         

1,299

 

Taxes on income

 

(350

)

 

49

   

13

   

17

   

21

   

488

     

238

 

Net income

$

1,023

                       

$

1,061

 
                           

Earnings per share - Diluted

$

3.99

                       

$

4.14

 

(1)

One-time spin-related costs includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US.

(2)

Other costs primarily includes a tax benefit resulting from the termination of a Swiss tax arrangement and one-time costs related to inventory step-up adjustments and legal reserves.
 

Year Ended December 31, 2022

 

GAAP

 

Spin related Costs(1)

 

Restructuring

 

Stock-based Compensation

 

Amortization

 

Other(2)

 

Non-GAAP Adjusted

Revenues

$

6,174

                       

$

6,174

 

Cost of sales

 

2,294

   

(25

)

 

   

(13

)

 

(116

)

 

(24

)

   

2,116

 

Gross profit

 

3,880

                         

4,058

 

Gross margin

 

62.8

%

                       

65.7

%

                           

Selling, general and administrative

 

1,704

   

(122

)

 

   

(51

)

 

   

(21

)

   

1,510

 

Research and development

 

471

   

(11

)

 

   

(11

)

 

   

(3

)

   

446

 

Acquired in-process research and development and milestones

 

107

   

   

   

   

   

     

107

 

Restructuring costs

 

28

   

   

(28

)

 

   

   

     

 

Interest expense

 

422

   

   

   

   

   

     

422

 

Exchange losses

 

11

   

   

   

   

   

     

11

 

Other expense (income), net

 

15

   

(23

)

 

   

   

   

3

     

(5

)

   

5,052

                         

4,607

 

Income before income taxes

 

1,122

                         

1,567

 

Taxes on income

 

205

   

36

   

6

   

13

   

19

   

4

     

283

 

Net income

$

917

                       

$

1,284

 
                           

Earnings per share - Diluted

$

3.59

                       

$

5.03

 

(1)

One-time spin-related costs includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US.

(2)

Other costs primarily includes one-time costs related to inventory step-up adjustments, 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

December 31,

 

Year Ended

December 31,

   

2023

     

2022

     

2023

     

2022

 

Income before income taxes

$

104

   

$

111

   

$

673

   

$

1,122

 

Depreciation (1)

 

30

     

24

     

118

     

96

 

Amortization

 

28

     

28

     

116

     

116

 

Interest expense

 

129

     

119

     

527

     

422

 

EBITDA

$

291

   

$

282

   

$

1,434

   

$

1,756

 

Restructuring costs

 

58

     

17

     

62

     

28

 

One-time costs (2)

 

73

     

58

     

347

     

226

 

Stock-based compensation

 

27

     

23

     

101

     

75

 

Adjusted EBITDA

$

449

   

$

380

   

$

1,944

   

$

2,085

 

Adjusted EBITDA margin

 

28.1

%

   

25.6

%

   

31.0

%

   

33.8

%

(1)

Excludes accelerated depreciation included in one-time costs.

(2)

One-time costs primarily include costs incurred in connection with the spin-off of Organon, inventory step-up adjustments, impairment charges and legal reserves.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240215838725/en/

Contacts

Media Contacts:
Karissa Peer
(614) 314-8094

Kate Vossen
(732) 675-8448

Investor Contacts:
Jennifer Halchak
(201) 275-2711

Alex Arzeno
(203) 550-3972

Source: Organon & Co.

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