Organon Reports Results for the Second Quarter Ended June 30, 2023

Organon (NYSE: OGN) today announced its results for the second quarter ended June 30, 2023.

  • Second quarter 2023 revenue of $1,608 million
  • Second quarter 2023 diluted earnings per share of $0.95 and non-GAAP Adjusted diluted earnings per share of $1.31
  • Adjusted EBITDA of $530 million
  • Board of Directors declares quarterly dividend of $0.28 per share
  • Full year 2023 financial guidance ranges updated:
    • Revenue range narrowed to $6.25 billion to $6.45 billion, primarily reflecting current foreign currency exchange rates
    • Adjusted EBITDA margin range now 31.5%-33.0% to incorporate current visibility on IPR&D (in-process research and development) and milestones

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

“During the second quarter of 2023, Organon continued to build on its track record, delivering solid volume growth across all regions and franchises. The Women’s Health and Biosimilars franchise revenue grew 10% and 15% excluding the impact of foreign currency (“ex-FX”), respectively, and Established Brands continued to demonstrate stability,” said Kevin Ali, Organon’s CEO. “Further, on July 1st we launched Hadlima™ (adalimumab-bwwd) in the United States - so far our biggest commercial launch in the U.S. as a standalone company. Hadlima is emerging as one of a few biosimilars offerings earning commercial success so far. We are encouraged by our early traction and remain confident in our strategy, the attributes of our product and our collaborator’s capabilities to deliver reliable supply.”

Second Quarter 2023 Revenue

in $ millions

Q2 2023

Q2 2022

VPY

VPY ex-FX

Women’s Health

$

438

$

408

8%

10%

Biosimilars

135

119

14%

15%

Established Brands

995

1,018

(2)%

—%

Other (1)

40

40

(2)%

(1)%

Revenues

$

1,608

$

1,585

1%

4%

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

For the second quarter of 2023, total revenue was $1,608 million, an increase of 1% as-reported and an increase of 4% excluding the impact of foreign currency (ex-FX), compared with the second quarter of 2022.

Women’s Health revenue increased 8% on an as-reported basis, and increased 10% ex-FX in the second quarter of 2023 compared with the second quarter of 2022 driven primarily by a 12% ex-FX increase in Nexplanon® (etonogestrel implant), a long-acting reversible contraceptive. The Women’s Health franchise also benefited from 17% ex-FX growth in the fertility portfolio during the quarter due to COVID-19 recovery in China as well as strong demand in the LAMERA region and in the U.S. Growth in the Women’s Health franchise was partially offset by a 3% ex-FX decrease of NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) which continues to be impacted by generic competition.

Biosimilars revenue increased 14% as-reported and 15% ex-FX in the second quarter of 2023, compared with the second quarter of 2022 primarily driven by Renflexis® (infliximab-abda) which grew 20% ex-FX due to continued demand and strong volume growth in United States and Canada. Growth in the biosimilars franchise was partially offset by a 7% ex-FX decline in Ontruzant® (trastuzumab-dttb) primarily related to ongoing competitive pressures in Europe. On July 1, 2023, the company launched Hadlima, a biosimilar to Humira (adalimumab) (a trademark of AbbVie Biotechnology Ltd.) in the United States. Organon already markets Hadlima in Canada and Australia.

Established Brands revenue decreased 2% as-reported and was flat ex-FX in the second quarter of 2023, despite the negative impact from Volume Based Procurement (VBP) initiatives in China and the year over year impact of the company’s market action taken in the first quarter of 2023 on select injectable steroids, Diprospan™ (bethamethasone), and Celestone Chronodose™ (bethamethasone), and Celestone Soluspan™ (bethamethasone). Offsetting factors included an 18% ex-FX year over year increase in Atozet™ (ezetimibe and atorvastatin calcium) which was driven by increased demand in the EUCAN region, as well as 23% ex-FX growth in Arcoxia™ (etoricoxib) which was driven by increased volume in the LAMERA region. Year to date, the Established Brands portfolio has grown 1% ex-FX, as 2% volume growth has offset an approximate 1% decline in price across the portfolio. The company continues to expect the Established Brands franchise to achieve flat revenue growth for the full year 2023.

Second Quarter 2023 Profitability

in $ millions, except per share amounts

Q2 2023

Q2 2022

VPY

Revenues

$

1,608

$

1,585

1%

Cost of sales

640

588

9%

Gross profit

968

997

(3)%

Non-GAAP Adjusted gross profit (1)

1,012

1,047

(3)%

Adjusted EBITDA (1,2)

530

512

4%

Net income

242

234

3%

Non-GAAP Adjusted net income (1)

336

319

5%

Diluted Earnings per Share (EPS)

0.95

0.92

3%

Non-GAAP Adjusted diluted EPS (1)

1.31

1.25

5%

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

97

NM

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

(0.30)

NM

Q2 2023

Q2 2022

Gross margin

60.2%

62.9%

Non-GAAP Adjusted gross margin (1)

62.9%

66.1%

Adjusted EBITDA margin (1,2)

33.0%

32.3%

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

(2) Adjusted EBITDA and Adjusted EBITDA margin include $97 million in the second quarter of 2022 related to acquired IPR&D and milestones, no such expense was incurred in the second quarter of 2023

Gross margin was 60.2% as-reported and 62.9% on an adjusted basis in the second quarter of 2023 compared to 62.9% as-reported and 66.1% on an adjusted basis in the second quarter of 2022. The year-over-year decline in gross margin is primarily due to product mix as well as employee-related costs and distribution related costs, which increased as a result of inflationary pressures in 2023.

Adjusted EBITDA margin was 33.0% in the second quarter of 2023 compared to 32.3% in the second quarter of 2022. The increase in Adjusted EBITDA margin was primarily a result of $97 million of IPR&D and milestones in the second quarter of 2022; no such costs were incurred in the second quarter of 2023.

Net income for the second quarter of 2023 was $242 million, or $0.95 per diluted share, compared with $234 million, or $0.92 per diluted share, in the second quarter of 2022. Non-GAAP Adjusted net income was $336 million, or $1.31 per diluted share, compared with $319 million, or $1.25 per diluted share, in 2022. The year over year increase in net income was a result of higher Adjusted EBITDA compared with the second quarter of 2022 as well as a tax benefit in the second quarter of 2023 related to earnings outside of the U.S., partially offset by higher interest expense associated with the company’s variable rate debt.

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 September 14, 2023, to stockholders of record at the close of business on August 18, 2023.

As of June 30, 2023, cash and cash equivalents were $326 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 May 4, 2023. The range for full year 2023 revenue is narrowed to $6.25 billion to $6.45 billion, which primarily reflects current foreign currency exchange rates. The range for full year Adjusted EBITDA margin is now 31.5% to 33.0% to incorporate the company’s current visibility of IPR&D and milestone expenses expected to be incurred in 2023. 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
May 4, 2023

Current guidance

Revenues

$6.150B - $6.450B

$6.250B-$6.450B

Adjusted gross margin

Low-mid 60% range

Unchanged

SG&A (as % of revenue)

Mid 20% range

Unchanged

R&D (as % of revenue)

Upper single-digit

Unchanged

Adjusted EBITDA margin

31.0%-33.0%

31.5%-33.0%

Interest

~$515 million

~$525 million

Depreciation

~$130 million

~$120 million

Effective non-GAAP tax rate

19.0% - 21.0%

17.5% - 19.5%

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 second 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/jgIqShwa

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, 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. Forward-looking statements may be identified by words such as “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; 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, 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
June 30,

Six Months Ended
June 30,

2023

2022

2023

2022

Revenues

$

1,608

$

1,585

$

3,146

$

3,152

Costs, Expenses and Other

Cost of sales

640

588

1,220

1,149

Selling, general and administrative

451

423

886

794

Research and development

128

106

257

202

Acquired in-process research and development and milestones

97

8

97

Restructuring costs

4

Interest expense

132

98

264

195

Exchange losses (gains)

2

(21

)

11

(25

)

Other expense, net

1

7

7

11

1,354

1,298

2,657

2,423

Income Before Income Taxes

254

287

489

729

Taxes on income

12

53

70

147

Net Income

242

234

419

582

Earnings per Share:

Basic

$

0.95

$

0.92

$

1.64

$

2.29

Diluted

$

0.95

$

0.92

$

1.64

$

2.28

Weighted Average Shares Outstanding:

Basic

255,341

254,018

254,869

253,802

Diluted

255,953

255,156

256,064

255,105

TABLE 2

Organon & Co.
Sales by top products
(Unaudited, $ in millions)

Three Months Ended June 30,

Six Months Ended June 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

$

159

$

56

$

214

$

134

$

61

$

195

$

272

$

107

$

380

$

250

$

116

$

366

Follistim AQ

26

44

70

23

35

58

52

73

125

52

66

119

NuvaRing

17

23

40

22

20

42

33

47

80

38

45

83

Ganirelix Acetate Injection

4

29

34

6

25

32

11

53

63

14

47

61

Marvelon/Mercilon

29

29

31

31

67

67

54

54

Other Women’s Health (1)

27

25

52

29

22

51

53

52

105

56

47

103

Biosimilars

Renflexis

60

11

70

51

8

59

114

18

132

93

12

105

Ontruzant

12

21

33

12

23

35

25

29

54

19

38

57

Brenzys

13

13

14

14

32

32

28

28

Aybintio

12

12

9

9

22

22

19

19

Hadlima

7

7

2

2

12

12

8

8

Established Brands

Cardiovascular

Zetia

2

89

90

2

99

101

4

169

173

5

195

200

Vytorin

1

37

38

3

32

35

3

65

67

5

68

73

Atozet

143

143

122

122

271

271

240

240

Rosuzet

17

17

16

16

35

35

38

38

Cozaar/Hyzaar

2

69

71

2

91

92

4

152

156

10

176

186

Other Cardiovascular (1)

1

41

41

1

45

46

1

81

82

2

83

85

Respiratory

Singulair

3

77

80

3

89

92

5

194

199

5

216

222

Nasonex

64

64

58

58

133

133

9

123

133

Dulera

38

10

48

36

12

47

76

18

95

67

21

88

Clarinex

1

38

39

1

34

35

2

77

79

2

70

73

Other Respiratory (1)

13

6

19

11

11

22

25

12

37

23

22

45

Non-Opioid Pain, Bone and Dermatology

Arcoxia

72

72

61

61

143

143

121

121

Fosamax

1

44

44

1

39

40

1

81

82

2

79

81

Diprospan

12

12

31

31

27

27

63

63

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

2

67

71

5

71

76

7

127

133

8

137

145

Other

Proscar

24

25

26

26

1

51

52

1

50

50

Propecia

2

35

36

2

33

35

4

66

69

3

63

66

Other (1)

2

81

84

7

74

82

4

156

162

15

149

164

Other (2)

(2

)

41

40

40

40

79

79

1

78

76

Revenues

$

371

$

1,237

$

1,608

$

351

$

1,234

$

1,585

$

697

$

2,449

$

3,146

$

680

$

2,472

$

3,152

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™ 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
June 30,

Six Months Ended
June 30,

2023

2022

2023

2022

Europe and Canada

$

467

$

443

$

867

$

880

United States

371

351

697

680

Asia Pacific and Japan

261

291

585

604

China

234

244

459

480

Latin America, Middle East, Russia and Africa

234

216

448

425

Other (1)

41

40

90

83

Revenues

$

1,608

$

1,585

$

3,146

$

3,152

(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 June 30, 2023

GAAP

Spin related
Costs(1)

Restructuring

Stock-based
Compensation

Amortization

Other(1)

Non-GAAP
Adjusted

Revenues

$

1,608

$

1,608

Cost of sales

640

(10

)

(4

)

(30

)

596

Gross profit

968

1,012

Gross margin

60.2

%

62.9

%

Selling, general and administrative

451

(44

)

(17

)

390

Research and development

128

(3

)

(4

)

121

Acquired in-process research and development and milestones

Restructuring costs

Interest expense

132

132

Exchange losses

2

2

Other expense (income), net

1

(4

)

(3

)

1,354

1,238

Income before income taxes

254

370

Taxes on income

12

13

4

5

34

Net income

$

242

$

336

Earnings per share - Diluted

$

0.95

$

1.31

(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 and legal reserves.

Three Months Ended June 30, 2022

GAAP

Spin related
Costs(1)

Restructuring

Stock-based
Compensation

Amortization

Other(1)

Non-GAAP
Adjusted

Revenues

$

1,585

$

1,585

Cost of sales

588

(6

)

(3

)

(28

)

(13

)

538

Gross profit

997

1,047

Gross margin

62.9

%

66.1

%

Selling, general and administrative

423

(28

)

(13

)

382

Research and development

106

(3

)

(3

)

100

Acquired in-process research and development and

97

97

Restructuring costs

Interest expense

98

98

Exchange gains

(21

)

(21

)

Other expense (income), net

7

(8

)

(1

)

1,298

1,193

Income before income taxes

287

392

Taxes on income

53

10

3

4

3

73

Net income

$

234

$

319

Earnings per share - Diluted

$

0.92

$

1.25

(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 and legal reserves.

TABLE 4 (Continued)

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
(Unaudited, $ in millions except per share amounts)

Six Months Ended June 30, 2023

GAAP

Spin related
Costs(1)

Restructuring

Stock-based
Compensation

Amortization

Other(1)

Non-GAAP
Adjusted

Revenues

$

3,146

$

3,146

Cost of sales

1,220

(20

)

(8

)

(59

)

(2

)

1,131

Gross profit

1,926

2,015

Gross margin

61.2

%

64.0

%

Selling, general and administrative

886

(90

)

(32

)

(1

)

763

Research and development

257

(6

)

(7

)

244

Acquired in-process research and development and milestones

8

8

Restructuring costs

4

(4

)

Interest expense

264

264

Exchange losses

11

11

Other expense (income), net

7

(10

)

(3

)

2,657

2,418

Income before income taxes

489

728

Taxes on income

70

26

1

8

11

116

Net income

$

419

$

612

Earnings per share - Diluted

$

1.64

$

2.39

(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 and legal reserves.

Six Months Ended June 30, 2022

GAAP

Spin related
Costs(1)

Restructuring

Stock-based
Compensation

Amortization

Other(1)

Non-GAAP
Adjusted

Revenues

$

3,152

$

3,152

Cost of sales

1,149

(10

)

(6

)

(56

)

(14

)

1,063

Gross profit

2,003

2,089

Gross margin

63.5

%

66.3

%

Selling, general and administrative

794

(53

)

(23

)

718

Research and development

202

(6

)

(5

)

(1

)

190

Acquired in-process research and development and

97

97

Restructuring costs

Interest expense

195

195

Exchange gains

(25

)

(25

)

Other expense (income), net

11

(14

)

(3

)

2,423

2,235

Income before income taxes

729

917

Taxes on income

147

14

5

9

3

178

Net income

$

582

$

739

Earnings per share - Diluted

$

2.28

$

2.90

(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 and legal reserves.

TABLE 5

Organon & Co.
Reconciliation of GAAP Income Before Income Taxes to Adjusted EBITDA
(Unaudited, $ in millions)

Three Months Ended
June 30,

Six Months Ended
June 30,

2023

2022

2023

2022

Income before income taxes

$

254

$

287

$

489

$

729

Depreciation

28

22

56

47

Amortization

30

28

59

56

Interest expense

132

98

264

195

EBITDA

$

444

$

435

$

868

$

1,027

Restructuring costs

4

One-time costs (1)

61

58

129

98

Stock-based compensation

25

19

47

34

Adjusted EBITDA

$

530

$

512

$

1,048

$

1,159

Adjusted EBITDA margin

33.0

%

32.3

%

33.3

%

36.8

%

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

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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