• Second quarter 2022 revenues of $1,585 million
  • Second quarter diluted earnings per share from continuing operations of $0.92 and non-GAAP adjusted diluted earnings per share from continuing operations of $1.25
  • Both reported and non-GAAP adjusted diluted earnings per share include a negative impact of $0.30 for acquired in-process research and development (IPR&D) and milestones
  • Adjusted EBITDA of $512 million, inclusive of $97 million of acquired IPR&D and milestones
  • Board of Directors declares quarterly dividend of $0.28 per share
  • Full year 2022 financial guidance ranges updated:

    • Revenues range narrowed to $6.1 billion to $6.3 billion, and reflects persisting foreign currency headwinds
    • Adjusted EBITDA margin range now 32%-34% to incorporate acquired IPR&D and milestone expenses from recent business development


Organon (NYSE: OGN) (the “company”), today announced its results for the second quarter ended June 30, 2022.

“During the second quarter, Organon delivered constant currency growth across all our reported geographies and in all three franchises. Our Established Brands franchise grew in almost every therapy area, demonstrating the sustainability and untapped potential of these brands,” said Kevin Ali, Organon’s Chief Executive Officer. “Additionally, we continued to invest for growth during the quarter adding Shanghai Henlius Biotech as another R&D and manufacturing collaborator for biosimilars, underscoring our commitment to this business. And importantly, we further expanded our offerings in Women’s Health recently signing a research collaboration with Cirqle Biomedical for a novel investigational non-hormonal, on-demand contraceptive candidate.”


Second quarter 2022 revenues

in $ millions

Q2 2022

Q2 2021

VPY

VPY ex-FX

Women’s Health

$

408

$

417

(2)%

 

1%

Biosimilars

 

119

 

86

39%

 

42%

Established Brands

 

1,018

 

1,045

(2)%

 

4%

Other (1)

 

40

 

47

(17)%

 

(18)%

Revenues

$

1,585

$

1,595

(1)%

 

5%


(1)

Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties, and allocated amounts from pre-spin revenue hedging activities.

Total net revenues were $1,585 million for the second quarter of 2022, a decrease of 1% as-reported and an increase of 5% excluding the impact of foreign currency (ex-FX), compared with the second quarter of 2021.

Women’s Health declined 2% as-reported, but increased 1% ex-FX in the second quarter of 2022 compared with the second quarter of 2021. During the second quarter of 2022, Nexplanon® (etonogestrel implant) grew 8% ex-FX, primarily driven by favorable pricing and demand uptake in the United States and volume growth outside the United States. Nuvaring® (etonogestrel/ethinyl estradiol vaginal ring) continues to be impacted by generic competition and declined 18% ex-FX in the second quarter of 2022 compared with the prior year period. Follistim AQ® (follitropin beta injection), declined 9% ex-FX in the second quarter of 2022, primarily due to COVID-related disruptions in China and an unfavorable channel mix in the United States, that offset solid demand.

Biosimilars revenue grew 39% as-reported and 42% ex-FX in the second quarter 2022 compared with the second quarter of 2021. Organon’s current portfolio includes certain immunology and oncology treatments. All five of the biosimilars in Organon’s portfolio have launched in certain countries globally, including two biosimilars, Renflexis® (infliximab-abda) and Ontruzant® (trastuzumab-dttb), in the United States. Renflexis grew 39% ex-FX in the second quarter of 2022 compared with the prior year period, primarily due to continued demand growth in the United States since its launch in 2017. Ontruzant grew 61% ex-FX driven by timing of an order in Brazil, as well as continued uptake in the United States since its launch in July 2020, partially offset by increased competition in Europe.

Established Brands represents a broad portfolio of well-known medicines, which are generally beyond market exclusivity, including leading brands in cardiovascular, respiratory, dermatology and non-opioid pain management, and for which generic competition varies by market. The portfolio’s exposure to loss of exclusivity (LOE) risk peaked in 2021 and no longer represents a significant impediment to stable performance in the Established Brands franchise. Revenues for Established Brands decreased 2% as-reported and increased 4% ex-FX in the second quarter of 2022 compared with the second quarter of 2021. During the second quarter of 2022, the cardiovascular portfolio grew 3% ex-FX primarily driven by strong Atozet™ (ezetimibe and atorvastatin calcium) sales in Europe and Cozaar® (losartan potassium) /Hyzaar® (losartan potassium and hydrochlorothiazide) sales in China. The Established Brands franchise also benefited from a continuation of a temporary supply disruption affecting several competitors in the Japanese market, most notably in the respiratory portfolio. Year to date, the franchise has not experienced significant impacts from the implementation of Volume Based Procurement (VBP) in China, which the company expects will be more pronounced in the second half of 2022. Still, based on the strong year to date performance, the company expects the Established Brands franchise to deliver relatively flat constant currency revenue growth for the full year 2022.


Second quarter 2022 profitability


Organon was spun-off from Merck & Co., Inc., Rahway, NJ, USA on June 2, 2021. Financial results during the pre-spin period were presented on the carve-out basis of accounting and do not purport to reflect what Organon’s financial results would have been had Organon operated as a standalone public company. Therefore, with the exception of revenue, financial results for the periods ending June 30, 2022 and June 30, 2021 are not meaningfully comparable.

in $ millions, except per share amounts

 

Q2 2022

 

Q2 2021

mid-year spin

 

VPY

Revenues

 

$

1,585

 

$

1,595

 

(1)%

Gross profit

 

 

997

 

 

1,012

 

(1)%

Non-GAAP Adjusted Gross Profit (1)

 

 

1,047

 

 

1,047

 

—%

Adjusted EBITDA (1,2)

 

 

512

 

 

627

 

(18)%

Net Income, continuing operations

 

 

234

 

 

431

 

(46)%

Non-GAAP adjusted net income, continuing operations (1)

 

 

319

 

 

437

 

(27)%

Diluted Earnings per Share (EPS), continuing operations

 

 

0.92

 

 

1.70

 

(46)%

Non-GAAP adjusted diluted EPS, continuing operations (1)

 

 

1.25

 

 

1.72

 

(27)%

Acquired IPR&D and milestones

 

 

97

 

 

 

NM

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

 

 

(0.30)

 

 

 

NM

 

Q2 2022

 

Q2 2021

mid-year spin

Gross margin

 

62.9%

 

63.4 %

Non-GAAP Adjusted Gross Margin
(1)

 

66.1%

 

65.6 %

Adjusted EBITDA margin (1,2)

 

32.3%

 

39.3 %


(1)

See Tables 4,5 and 6 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

Gross margin in the second quarter of 2022 was 62.9% as-reported, and comparable to 63.4% in the prior year period. Adjusted Gross Margin was 66.1% in the second quarter of 2022 compared with 65.6% on an adjusted basis in the second quarter of 2021.

Adjusted EBITDA margin was 32.3% in the second quarter of 2022 compared with 39.3% in the second quarter of 2021. Adjusted EBITDA margin in the second quarter of 2022 is inclusive of $97 million of acquired IPR&D and milestones. Higher R&D spend associated with the company’s recent acquisitions of clinical stage assets as well as higher employee related costs contributed to the decline in Adjusted EBITDA margin year over year.

Net income from continuing operations for the second quarter of 2022 was $234 million, or $0.92 per diluted share, compared with $431 million, or $1.70 per diluted share, in the second quarter of 2021. Non-GAAP Adjusted net income from continuing operations was $319 million, or $1.25 per diluted share, compared with $437 million, or $1.72 per diluted share, in 2021.

Beginning in 2022, Organon will no longer exclude expenses for upfront and milestone payments related to collaborations and licensing agreements, or charges related to pre-approval assets obtained in transactions accounted for as asset acquisitions from its non-GAAP results. The change to include all acquired IPR&D and milestone expenses negatively impacted Adjusted diluted EPS by $0.30 in the second quarter of 2022. There was no similar impact in the second quarter of 2021. In connection with this change, acquired IPR&D expenses are now reported as a separate income statement line item. These costs were previously recorded within the R&D expenses line. Prior period amounts have been revised to conform to the current period presentation.


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 15, 2022 to stockholders of record at the close of business on August 15, 2022.

As of June 30, 2022, cash and cash equivalents were $545 million, and debt was $8.9 billion. Total debt as of June 30, 2022 reflects a discretionary second quarter prepayment of $100 million on the company’s U.S. dollar denominated term loan.


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 2022 guidance ranges previously provided on May 5, 2022. The range for full year 2022 revenue is narrowed to $6.1 billion to $6.3 billion, which reflects persisting foreign exchange headwinds. The range for full year Adjusted EBITDA margin is now 32% to 34% to incorporate approximately $110 million of IPR&D and milestone expenses from business development through August 4, 2022. Organon’s financial guidance does not assume an estimate for future IPR&D and milestone payments for business development transactions not yet executed.

 

Previous guidance

FX impact

IPR&D

Current guidance

Revenues

$6.1B – $6.4B

From 300-475 bps to 550-650 bps

 

$6.1B – $6.3B

Adjusted Gross margin

Mid 60%

 

 

Unchanged

SG&A (as % of revenue)

Mid 20%

 

 

Unchanged

R&D (as % of revenue)

Mid-upper single digit

 

 

Upper single-digit

Adjusted EBITDA margin

34%-36%

 

~($110)M

32% – 34%

Interest

~$400 million

 

 

Unchanged

Depreciation

$100-$115 million

 

 

Unchanged

Effective Non-GAAP tax rate

17.5%-19.5%

 

 

Unchanged

Fully diluted weighted avg. shares outstanding

~255 million

 

 

Unchanged


Webcast Information


Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its second quarter 2022 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/. 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 using conference ID# 58511-993 and by clicking on this link: https://conferencingportals.com/event/ZGyfDfjk. 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 has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in innovation and future growth opportunities in women’s health. 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 9,300 employees with headquarters located in Jersey City, New Jersey. For more information, visit http://www.organon.com and connect with us on LinkedIn and Instagram.

Non-GAAP financial measures

This press release contains “non-GAAP financial measures,” which are financial measures that either exclude or include amounts that are 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 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. 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 the appendix 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 2022 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 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.

Forward-Looking Statement

Except for historical information herein, 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 execute on our business development strategy or realize the benefits of our planned acquisitions; general economic factors, including 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, 2021 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 June 30,

 

Six Months Ended June 30,

 

 

2022

 

 

 

2021

 

 

 

2022

 

 

 

2021

 

Revenues

$

1,585

 

 

$

1,595

 

 

$

3,152

 

 

$

3,101

 

Costs, Expenses and Other

 

 

 

 

 

 

 

Cost of sales

 

588

 

 

 

583

 

 

 

1,149

 

 

 

1,174

 

Selling, general and administrative

 

423

 

 

 

416

 

 

 

794

 

 

 

798

 

Research and development

 

106

 

 

 

76

 

 

 

202

 

 

 

143

 

Acquired in-process research and development and milestones

 

97

 

 

 

 

 

 

97

 

 

 

 

Restructuring costs

 

 

 

 

1

 

 

 

 

 

 

2

Interest expense

 

98

 

 

 

62

 

 

 

195

 

 

 

62

 

Other (income) expense, net

 

(14

)

 

 

20

 

 

 

(14

)

 

 

18

 

 

 

1,298

 

 

 

1,158

 

 

 

2,423

 

 

 

2,197

 

Income From Continuing Operations Before Income Taxes

 

287

 

 

 

437

 

 

 

729

 

 

 

904

 

Taxes on Income

 

53

 

 

 

6

 

 

 

147

 

 

 

78

 

Net Income From Continuing Operations

 

234

 

 

 

431

 

 

 

582

 

 

 

826

 

Loss From Discontinued Operations – Net of Tax

 

 

 

 

(4

)

 

 

 

 

 

 

Net Income

 

234

 

 

 

427

 

 

 

582

 

 

 

826

 

Earnings (Loss) per Share Attributable to Organon & Co. Stockholders – Basic:

 

 

 

 

 

 

 

Continuing operations

$

0.92

 

 

$

1.70

 

 

$

2.29

 

 

$

3.26

 

Discontinued operations

 

 

 

 

(0.02

)

 

 

 

 

 

 

Net Earnings per Share Attributable to Organon & Co. Stockholders

$

0.92

 

 

$

1.68

 

 

$

2.29

 

 

$

3.26

 

Earnings (Loss) per Share Attributable to Organon & Co. Stockholders – Diluted:

 

 

 

 

 

 

 

Continuing operations

$

0.92

 

 

$

1.70

 

 

$

2.28

 

 

$

3.25

 

Discontinued operations

 

 

 

 

(0.02

)

 

 

 

 

 

 

Net Earnings per Share Attributable to Organon & Co. Stockholders

$

0.92

 

 

$

1.68

 

 

$

2.28

 

 

$

3.25

 

Weighted Average Shares Outstanding:

 

 

 

 

 

 

 

Basic

 

254,018

 

 

 

253,516

 

 

 

253,802

 

 

 

253,516

 

Diluted

 

255,156

 

 

 

253,828

 

 

 

255,105

 

 

 

253,828

 

 

TABLE 2

Organon & Co.

Sales by top products

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

2022

 

2021

 

2022

 

2021

($ in millions)

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

$

134

 

$

61

 

$

195

 

$

129

 

$

56

 

$

184

 

$

250

 

$

116

 

$

366

 

$

269

 

$

98

 

$

368

Follistim AQ

 

23

 

 

35

 

 

58

 

 

27

 

 

38

 

 

65

 

 

52

 

 

66

 

 

119

 

 

52

 

 

65

 

 

117

NuvaRing

 

22

 

 

20

 

 

42

 

 

26

 

 

28

 

 

53

 

 

38

 

 

45

 

 

83

 

 

47

 

 

52

 

 

98

Ganirelix Acetate Injection

 

6

 

 

25

 

 

32

 

 

5

 

 

25

 

 

31

 

 

14

 

 

47

 

 

61

 

 

14

 

 

46

 

 

60

Cerazette

 

 

 

15

 

 

15

 

 

 

 

18

 

 

18

 

 

 

 

32

 

 

32

 

 

 

 

34

 

 

34

Other Women’s Health(1)

 

29

 

 

38

 

 

67

 

 

23

 

 

43

 

 

66

 

 

56

 

 

69

 

 

125

 

 

63

 

 

76

 

 

139

Biosimilars

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Renflexis

 

51

 

 

8

 

 

59

 

 

36

 

 

7

 

 

43

 

 

93

 

 

12

 

 

105

 

 

70

 

 

11

 

 

81

Ontruzant

 

12

 

 

23

 

 

35

 

 

7

 

 

15

 

 

22

 

 

19

 

 

38

 

 

57

 

 

11

 

 

34

 

 

45

Brenzys

 

 

 

14

 

 

14

 

 

 

 

11

 

 

11

 

 

 

 

28

 

 

28

 

 

 

 

21

 

 

21

Aybintio

 

 

 

9

 

 

9

 

 

 

 

8

 

 

8

 

 

 

 

19

 

 

19

 

 

 

 

16

 

 

16

Hadlima

 

 

 

2

 

 

2

 

 

 

 

2

 

 

2

 

 

 

 

8

 

 

8

 

 

 

 

4

 

 

4

Established Brands

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cardiovascular

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zetia

 

2

 

 

99

 

 

101

 

 

2

 

 

97

 

 

99

 

 

5

 

 

195

 

 

200

 

 

4

 

 

186

 

 

190

Vytorin

 

3

 

 

32

 

 

35

 

 

2

 

 

42

 

 

45

 

 

5

 

 

68

 

 

73

 

 

5

 

 

81

 

 

86

Atozet

 

 

 

122

 

 

122

 

 

 

 

121

 

 

121

 

 

 

 

240

 

 

240

 

 

 

 

233

 

 

233

Rosuzet

 

 

 

16

 

 

16

 

 

 

 

18

 

 

18

 

 

 

 

38

 

 

38

 

 

 

 

33

 

 

33

Cozaar/Hyzaar

 

2

 

 

91

 

 

92

 

 

2

 

 

84

 

 

86

 

 

10

 

 

176

 

 

186

 

 

6

 

 

171

 

 

177

Other Cardiovascular(1)

 

1

 

 

45

 

 

46

 

 

1

 

 

60

 

 

61

 

 

2

 

 

83

 

 

85

 

 

2

 

 

98

 

 

100

Respiratory

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Singulair

 

3

 

 

89

 

 

92

 

 

3

 

 

89

 

 

92

 

 

5

 

 

216

 

 

222

 

 

8

 

 

191

 

 

199

Nasonex

 

 

 

58

 

 

58

 

 

1

 

 

51

 

 

52

 

 

9

 

 

123

 

 

133

 

 

3

 

 

92

 

 

95

Dulera

 

36

 

 

12

 

 

47

 

 

42

 

 

10

 

 

52

 

 

67

 

 

21

 

 

88

 

 

73

 

 

18

 

 

91

Clarinex

 

1

 

 

34

 

 

35

 

 

2

 

 

29

 

 

30

 

 

2

 

 

70

 

 

73

 

 

3

 

 

52

 

 

55

Other Respiratory(1)

 

11

 

 

11

 

 

22

 

 

13

 

 

9

 

 

22

 

 

23

 

 

22

 

 

45

 

 

29

 

 

15

 

 

44

Non-Opioid Pain, Bone and Dermatology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Arcoxia

 

 

 

61

 

 

61

 

 

 

 

62

 

 

62

 

 

 

 

121

 

 

121

 

 

 

 

119

 

 

119

Fosamax

 

1

 

 

39

 

 

40

 

 

1

 

 

48

 

 

49

 

 

2

 

 

79

 

 

81

 

 

2

 

 

85

 

 

86

Diprospan

 

 

 

31

 

 

31

 

 

 

 

32

 

 

32

 

 

 

 

63

 

 

63

 

 

 

 

57

 

 

57

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

 

5

 

 

71

 

 

76

 

 

4

 

 

72

 

 

75

 

 

8

 

 

137

 

 

145

 

 

3

 

 

133

 

 

136

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proscar

 

 

 

26

 

 

26

 

 

 

 

31

 

 

32

 

 

1

 

 

50

 

 

50

 

 

1

 

 

63

 

 

64

Propecia

 

2

 

 

33

 

 

35

 

 

2

 

 

34

 

 

36

 

 

3

 

 

63

 

 

66

 

 

4

 

 

63

 

 

67

Other(1)

 

7

 

 

74

 

 

82

 

 

13

 

 

68

 

 

81

 

 

15

 

 

149

 

 

164

 

 

24

 

 

146

 

 

169

Other (2)

 

 

 

40

 

 

40

 

 

(2)

 

 

49

 

 

47

 

 

1

 

 

78

 

 

76

 

 

(3)

 

 

119

 

 

117

Revenues

$

351

 

$

1,234

 

$

1,585

 

$

339

 

$

1,257

 

$

1,595

 

$

680

 

$

2,472

 

$

3,152

 

$

690

 

$

2,412

 

$

3,101

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. 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, and allocated amounts from pre-spin revenue hedging activities.

 

TABLE 3

Organon & Co.

Sales by geographic area

(Unaudited, $ in millions)

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

($ in millions)

2022

 

2021

 

2022

 

2021

Europe and Canada

$

443

 

$

470

 

$

880

 

$

904

United States

 

351

 

 

339

 

 

680

 

 

690

Asia Pacific and Japan

 

291

 

 

309

 

 

604

 

 

587

China

 

244

 

 

236

 

 

480

 

 

442

Latin America, Middle East, Russia and Africa

 

216

 

 

190

 

 

425

 

 

357

Other (1)

 

40

 

 

51

 

 

83

 

 

121

Revenues

$

1,585

 

$

1,595

 

$

3,152

 

$

3,101


(1)

Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties, and allocated amounts from pre-spin revenue hedging activities.

 

TABLE 4

Reconciliation of GAAP Gross Margin to Non-GAAP Adjusted Gross Profit and Adjusted Gross Margin

($ in millions)

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

2022

 

 

 

2021

 

 

 

2022

 

 

 

2021

 

Revenues

$

1,585

 

 

$

1,595

 

 

$

3,152

 

 

$

3,101

 

Cost of sales

 

588

 

 

 

583

 

 

 

1,149

 

 

 

1,174

 

Gross Profit

 

997

 

 

 

1,012

 

 

 

2,003

 

 

 

1,927

 

Gross Margin

 

62.9

%

 

 

63.4

%

 

 

63.5

%

 

 

62.1

%

Amortization

 

28

 

 

 

22

 

 

 

56

 

 

 

42

 

One-time costs (1)

 

19

 

 

 

10

 

 

 

24

 

 

 

10

 

Stock-based compensation

 

3

 

 

 

3

 

 

 

6

 

 

 

5

 

Non-GAAP Adjusted Gross Profit
(2)

$

1,047

 

 

$

1,047

 

 

 

2,089

 

 

 

1,984

 


Non-GAAP Adjusted Gross Margin

 


66.1


%

 

 


65.6


%

 

 


66.3


%

 

 


64.0


%


(1)

One-time costs for the three and six months ended June 30, 2022 primarily include costs to stand up the Company and inventory step-up adjustments as well as a $9 million impairment charge related to a licensed intangible asset.


(2)

Non-GAAP Adjusted Gross Profit is calculated by excluding amortization, one-time costs, and the portion of stock-based compensation expense allocated to Cost of sales.

 

TABLE 5

Organon & Co.

Reconciliation of GAAP Income from Continuing Operations Before Income Taxes to Adjusted EBITDA

($ in millions)

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

2022

 

 

 

2021

 

 

 

2022

 

 

 

2021

 

Income from continuing operations before income taxes

$

287

 

 

$

437

 

 

$

729

 

 

$

904

 

Depreciation

 

22

 

 

 

21

 

 

 

47

 

 

 

39

 

Amortization (1)

 

28

 

 

 

22

 

 

 

56

 

 

 

42

 

Interest expense

 

98

 

 

 

62

 

 

 

195

 

 

 

62

 

EBITDA

$

435

 

 

$

542

 

 

$

1,027

 

 

$

1,047

 

Restructuring costs

 

 

 

 

1

 

 

 

 

 

 

2

 

One-time costs (2)

 

58

 

 

 

66

 

 

 

98

 

 

 

115

 

Stock-based compensation

 

19

 

 

 

18

 

 

 

34

 

 

 

29

 

Adjusted EBITDA

$

512

 

 

$

627

 

 

$

1,159

 

 

$

1,193

 


Adjusted EBITDA margin

 

32.3

%

 

 

39.3

%

 

 

36.8

%

 

 

38.5

%


(1)

Amortization in all periods is included in Cost of sales.


(2)

One-time costs primarily include costs incurred in connection with the spin-off of Organon, an impairment of a licensed intangible asset, and inventory step up adjustments. For the three months ended June 30, 2022, approximately $28 million of the one-time costs are recorded in Selling, general and administrative expenses, $19 million are recorded in Cost of sales, $8 million are recorded in Other (income) expense, and $3 million are recorded in Research and development. For the three months ended June 30, 2021, approximately $55 million of the one-time costs are recorded in Selling, general and administrative expenses, and approximately $10 million are recorded in Cost of sales.


(2)

One-time costs primarily include costs incurred in connection with the spin-off of Organon, an impairment of a licensed intangible asset, and inventory step-up adjustments. For the six months ended June 30, 2022, approximately $53 million of the one-time costs are recorded in Selling, general and administrative expenses, approximately $24 million are recorded in Cost of sales, $14 million are recorded in Other (income) expense, and $7 million are recorded in Research and development. For the six months ended June 30, 2021, approximately $104 million of the GAAP one-time costs are recorded in Selling, general and administrative expenses, and approximately $10 million are recorded in Cost of sales.

 

TABLE 6

Organon & Co.

Reconciliation of GAAP Income from Continuing Operations Before Income Taxes to Non-GAAP Adjusted Net Income

($ in millions, except per share amounts)

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

2022

 

 

 

2021

 

 

 

2022

 

 

2021

 

Income from continuing operations before income taxes

$

287

 

 

$

437

 

 

$

729

 

$

904

 

Adjustments:

 

 

 

 

 

 

Amortization (1)

 

28

 

 

22

 

 

56

 

 

42

Restructuring costs

 

 

 

 

1

 

 

 

 

 

2

 

One-time costs (2)

 

58

 

 

 

66

 

 

 

98

 

 

115

 

Stock-based compensation

 

19

 

 

 

18

 

 

 

34

 

 

29

 

Total Adjustments

 

105

 

 

 

107

 

 

 

188

 

 

188

 

Non-GAAP pre-tax income, continuing operations

$

392

 

 

$

544

 

 

$

917

 

$

1,092

 

Taxes on income as reported in accordance with GAAP

 

53

 

 

 

6

 

 

 

147

 

 

78

 

Tax benefit on adjustments

 

20

 

 

 

20

 

 

 

34

 

 

35

 

Tax benefit (deduction) on GAAP-only discrete items (3)

 

 

 

 

81

 

 

 

(3

)

 

91

 

Non-GAAP adjusted taxes on income

 

73

 

 

 

107

 

 

 

178

 

 

204

 

Non-GAAP adjusted net income, continuing operations

$

319

 

 

$

437

 

 

$

739

 

$

888

 

Non-GAAP adjusted net income, continuing operations per diluted share

$

1.25

 

 

$

1.72

 

 

$

2.90

 

$

3.50

 


(1)

Amortization in all periods is included in Cost of sales.


(2)

One-time costs primarily include costs incurred in connection with the spin-off of Organon, an impairment of a licensed intangible asset, and inventory step-up adjustments. For the three months ended June 30, 2022, approximately $28 million of the one-time costs are recorded in Selling, general and administrative expenses, $19 million are recorded in Cost of sales, $8 million are recorded in Other (income) expense, and $3 million are recorded in Research and development. For the three months ended June 30, 2021, approximately $55 million of the one-time costs are recorded in Selling, general and administrative expenses, and approximately $10 million are recorded in Cost of sales.


(2)

One-time costs primarily include costs incurred in connection with the spin-off of Organon, an impairment of a licensed intangible asset, and inventory step-up adjustments. For the six months ended June 30, 2022, approximately $53 million of the one-time costs are recorded in Selling, general and administrative expenses, approximately $24 million are recorded in Cost of sales, $14 million are recorded in Other (income) expense, and $7 million are recorded in Research and development. For the six months ended June 30, 2021, approximately $104 million of the GAAP one-time costs are recorded in Selling, general and administrative expenses, and approximately $10 million are recorded in Cost of sales.


(3)

For the three months ended June 30, 2021, the company recorded a tax benefit of approximately $70 million related to a portion of Non-U.S. step-up in tax basis as a result of its separation from Merck & Co., Inc., Rahway, NJ, USA.

 


Media Contacts:

Karissa Peer

(614) 314-8094

Kate Vossen

(732) 675-8448

Investor Contacts:

Jennifer Halchak

(201) 275-2711

Edward Barger

(267) 614-4669

Source: Organon & Co.

Collaboration continues to expand portfolio in women’s health to help address unmet needs


Organon (NYSE: OGN), a global women’s healthcare company, and Cirqle Biomedical today announced they have entered into a research collaboration and exclusive license agreement for a novel investigational non-hormonal, on-demand contraceptive candidate.

“As a leader in contraception, we believe it is critically important to bring forward new options for women, especially in the space of non-hormonal contraceptives, a category preferred by many with limited available options,” said Sandra Milligan, M.D., Organon’s head of Research and Development. “Organon is committed to driving innovation across women’s health and collaborating with companies like Cirqle Biomedical to support early science and bring forward new solutions that address the unmet needs of women.”

Encouraging preclinical research suggests that Cirqle has discovered a method that has the potential to create a temporary barrier to sperm transport by topically reinforcing the existing cervical mucus barrier.

“This collaboration is an important opportunity to advance our preclinical research exploring this asset’s first-in-class potential,” said Frederik Petursson Madsen, Cirqle Biomedical, CEO. “We are excited to join Organon to leverage Organon’s deep expertise in women’s and reproductive health to drive potential change for women who use contraception everywhere.”

Under the terms of the agreement, Cirqle will be responsible for conducting preclinical studies according to the mutually agreed research plan. Organon will obtain exclusive worldwide rights to develop and commercialize the asset. Cirqle is entitled to receive a $10 million upfront payment, potential milestone payments of up to $360 million and royalties based on net sales.

As stated on Organon’s first quarter conference call, to align with views expressed by the US Securities and Exchange Commission, beginning in 2022 Organon will no longer exclude expenses for upfront and milestone payments related to collaborations and licensing agreements, or charges related to pre-approval assets obtained in transactions accounted for as asset acquisitions, from its non-GAAP results. Organon’s financial guidance does not assume an estimate for these expenses associated with business development not yet executed, and accordingly, the $10 million upfront payment was not included in the full year 2022 guidance Organon provided on May 5, 2022. Organon does not plan to update its guidance inter-quarter based solely on these items.

About Cirqle Biomedical

Cirqle Biomedical is a pre-clinical stage life science company with the goal of developing a first-in-class non-hormonal contraceptive that can help address the demand from millions of women for an effective contraceptive with minimal side-effects. Cirqle Biomedical’s approach to contraception is based on engineering mucus to leverage the natural barrier properties of cervical mucus. Cirqle Biomedical was launched in 2019 in Copenhagen, Denmark, with backing from BioInnovation Institute (BII) and RH Capital, a San Francisco-based impact investor dedicated to women’s reproductive health. Cirqle Biomedical’s core ethos is to expand freedom and quality of life for women everywhere. We aim to solve the most prominent unmet medical needs in women’s health by developing groundbreaking user-centric innovations.

About Organon

Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in innovation and future growth opportunities in women’s health. 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 9,300 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn and Instagram.

Forward-Looking Statements

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 Organon’s research collaboration and exclusive license agreement with Cirqle Biomedical, the potential for Cirqle Biomedical’s program to produce a best-in-class non-hormonal, on-demand contraceptive, including the effectiveness of and market opportunity for Cirqle Biomedical’s investigational asset, and Organon’s goal of addressing the unmet needs of women. 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 Organon’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, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; 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; Organon’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 Organon’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Organon 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 Organon’s filings with the Securities and Exchange Commission (“SEC”), including Organon’s Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov).


Organon Media Contacts:

Karissa Peer

(614) 314-8094

Kate Vossen

(732) 675-8448

Organon Investor Contacts:

Jennifer Halchak

(201) 275-2711

Edward Barger

(267) 614-4669

Cirqle Media Contacts:

Onor Wilkinson

ow@cirqle.bio

Cirqle Investor Contacts:

Frederik Petursson Madsen

fm@cirqle.bio

Source: Organon & Co.


Organon (NYSE: OGN), a global women’s healthcare company will release its second quarter 2022 financial results on August 4, 2022, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT.

Interested parties may access the live call via webcast on the Organon 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 using conference ID# 58511-993 and by clicking on this link:
https://conferencingportals.com/event/ZGyfDfjk.

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 has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in innovation and future growth opportunities in women’s health. 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 9,300 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn and Instagram.


Organon Media Contacts:

Karissa Peer

(614) 314-8094

Kate Vossen

(732) 675-8448

Organon Investor Contacts:

Jennifer Halchak

(201) 275-2711

Edward Barger

(267) 614-4669

Source: Organon & Co.

Collaboration expands and underscores commitment to biosimilars portfolio and focus on women’s health with biosimilar candidates for osteoporosis and breast cancer


Organon (NYSE: OGN), a global women’s health company with deep expertise in biosimilar commercialization, today announced that it has entered into an agreement with Shanghai Henlius Biotech, Inc. (2696.HK), whereby Organon will license commercialization rights for biosimilar candidates referencing Perjeta® (pertuzumab, HLX11) and Prolia®/Xgeva® (denosumab, HLX14). Organon will acquire exclusive global commercialization rights except for China; including Hong Kong, Macau and Taiwan.

Pertuzumab is used for the treatment of certain patients with HER2+ breast cancer in combinations with trastuzumab and chemotherapy. In the US, 20% of people with breast cancer are HER2+. Denosumab is used for the treatment of certain patients with osteoporosis with high risk of fracture and for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastasis from solid tumors. Osteoporosis affects over 20% of women over the age of 50 globally.

“Biosimilars are a key growth pillar for Organon, and this collaboration represents the successful execution of our strategy to expand our biosimilars portfolio leveraging our strong global footprint and deep commercial expertise,” said Kevin Ali, CEO of Organon. “With our experience in biosimilars and women’s health, our goal is to help more patients gain access to treatments for breast cancer and osteoporosis, two areas that significantly impact the health of women.”

The agreement also includes an option to negotiate an exclusive license for global commercialization rights for a biosimilar candidate referencing Yervoy ® (ipilimumab, HLX13). Ipilimumab is used for the treatment of certain patients with unresectable or metastatic melanoma, as adjuvant treatment of certain patients with cutaneous melanoma, certain patients with Renal Cell Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma and Esophageal Cancer.

Consideration for the transaction includes an upfront payment of $73 million as well as additional payments upon the achievement of certain development, regulatory and commercial milestones. Henlius will be responsible for development and, if approved, will supply the products to Organon.

As stated on Organon’s first quarter conference call, to align with views expressed by the US Securities and Exchange Commission, beginning in 2022 Organon will no longer exclude expenses for upfront and milestone payments related to collaborations and licensing agreements, or charges related to pre-approval assets obtained in transactions accounted for as asset acquisitions, from its non-GAAP results. Organon’s financial guidance does not assume an estimate for these expenses associated with business development not yet executed, and accordingly, the $73 million upfront payment and an approximate $30 million for milestones expected to be achieved in 2022 were not included in the full year 2022 guidance the company provided on May 5, 2022. The company does not plan to update its guidance inter-quarter based solely on these items.

About HLX11 (pertuzumab biosimilar candidate)

HLX11 (anti-HER2 domain II humanized monoclonal antibody injection) is a biosimilar candidate of pertuzumab and is independently developed by Henlius. Pertuzumab is used in combination with trastuzumab and chemotherapy as neoadjuvant or adjuvant treatment for HER2 positive early breast cancer and in combination with trastuzumab and docetaxel in certain patients with HER2 positive metastatic or unresectable locally recurrent breast cancer. To date, HLX11 has met the primary endpoint in a Phase 1 clinical trial, showing similar pharmacokinetic and safety profiles to the reference drugs from different sources.

About HLX14 (denosumab biosimilar candidate)

HLX14 (recombinant anti-RANKL human monoclonal antibody injection) is a biosimilar candidate of denosumab and is independently developed by Henlius. Denosumab is used for a range of indications including for the treatment of postmenopausal women with osteoporosis at high risk for fracture, certain patients with giant cell tumor of bone, and skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

About Organon

Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in innovation and future growth opportunities in women’s health. 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 9,300 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn and Instagram.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 in Europe, 13 indications approved worldwide, and 2 New Drug Application (NDA) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (GMP).

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, Zercepac® in Europe), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors and its NDA for the treatment of squamous non-small cell lung cancer and extensive small-cell lung cancer (ES-SCLC) are under review. What’s more, Henlius has conducted over 20 clinical studies for 12 products and 10 combination therapies.

Forward-Looking Statement of Organon

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 the potential therapeutic benefits of HLX11 and HLX14; Organon’s ability to improve the lives of women; Henlius’ ability to offer high-quality, affordable and innovative biologics for patients worldwide; Henlius’ ability to advance the clinical development of HLX11 and HLX14; and the potential benefits of the Henlius License and Supply Agreement. 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 Organon’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, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; 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; Organon’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 Organon’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Organon 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 Organon’s filings with the Securities and Exchange Commission (“SEC”), including Organon’s Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov).


Organon Media Contacts:

Karissa Peer

(614) 314-8094

Kate Vossen

(732) 675-8448

Organon Investor Contacts:

Jennifer Halchak

(201) 275-2711

Edward Barger

(267) 614-4669

Source: Organon & Co.

Report lays out blueprint for achieving Organon’s purpose and business imperatives to help women and girls achieve their promise through better health

  • Launch of Her Promise ESG platform creates a framework by which Organon aims to advance innovation and progress in women’s health and contribute to UN Sustainable Development Goals
  • Through the Her Promise Access Initiative, Organon’s goal is to provide 100 million girls and women in low- and middle-income countries with affordable access to contraceptive options by 2030
  • Funding to global NGO Women Deliver for their Young Leaders Program and other advocacy work, including support for young people around the world to advocate for and advance women’s health and gender equality


Organon (NYSE: OGN), a global women’s healthcare company, today announced the publication of its inaugural Environmental, Social, and Governance (ESG) Report for 2021. The ESG Report introduces Organon’s ESG platform, known as Her Promise, and details how the company is working to help women and girls achieve the full potential of their promise through better health. The publication of the ESG Report and launch of Her Promise coincides with Organon’s one year anniversary and reflects the company’s vision to create a better and healthier every day for every woman around the world.

Organon Her Promise Mural found at Organon global headquarters in Jersey City, New Jersey. Created by local Japanese American artist Riiisa Boogie who crafts detailed imaginary through textile, nature, portraits, flowing abstractions and uniquely creative characters. (Photo: Organon)

Organon Her Promise Mural found at Organon global headquarters in Jersey City, New Jersey. Created by local Japanese American artist Riiisa Boogie who crafts detailed imaginary through textile, nature, portraits, flowing abstractions and uniquely creative characters. (Photo: Organon)

As the only global women’s health company of its kind, Organon is well positioned to help address several current and growing women’s health challenges. For example, nearly half of all pregnancies worldwide – about 121 million in total – are unintended. According to a 2019 study, an estimated 218 million women and girls (ages 15-49) in low-and-middle income countries had an unmet need for modern contraception. Through Her Promise, Organon is making focused investments and forming strategic partnerships with the goal of introducing and expanding access to health solutions that improve women’s health and advance gender equity, inside and outside Organon.

“In just one year, Organon has made considerable progress in addressing gender-related disparities in health by listening to women and investing in areas where high unmet needs exist. Since our launch, we have focused on treatment gaps that need to be addressed, like unintended pregnancy, fertility, post-partum hemorrhage, pre-term labor, endometriosis, and bacterial vaginosis, and will continue to strive to deliver innovation, improve access and expand choice for women,” says Kevin Ali, Organon’s Chief Executive Officer. “The goals stated in our first ESG Report create a roadmap for the future of how we will continue to propel forward and partner to transform the current women’s health environment.”

On its one-year anniversary, Organon is making the following goals to achieve Her Promise:

  • To improve access to low-cost contraceptive options in 69 of the world’s least developed countries. Through the OrganonHer Promise Access Initiative, Organon is working with global organizations to provide family planning information, education and access to low-cost contraceptive options. Organon’s goal is to provide 100 million girls and women in low- and middle- income countries with affordable access to contraceptive options by 2030.
  • To redefine and harness innovation in women’s health. Organon will dedicate a majority of its pre-clinical and clinical development activity toward the unmet health needs of women. Organon has already begun with development activities in high unmet need areas including postpartum hemorrhage, endometriosis, and pre-term labor.
  • Expand access to treatment options that improve her health and help secure her promise. Working together with global organizations, Organon plans to expand access to treatment options for post-partum hemorrhage in women, in both developed and developing markets. We will also seek to help address affordability of fertility treatments and access to education to decrease the unmet medical need in fertility.
  • Aim to achieve balanced gender representation through all levels of Organon globally by 2030 and pay equity. Organon has had a strong start by launching with a Board of Directors that consists of accomplished individuals with exceptional skills and expertise, and also represents gender and racial diversity. Currently, Organon’s Board is the most diverse healthcare board on the S&P 500.
  • Aim to support the transition to a low carbon economy, with an ambition to achieve net zero greenhouse gas emissions. We also aim to integrate water stewardship and circular economy principles into our business models. The report details concrete short- and mid-term actions we will take to meet these long-term ambitions.
  • Uphold the highest levels of ethics and integrity throughout its business.

In addition, as part of its commitment to advancing gender equity through Her Promise, Organon has provided US $1.4M to Women Deliver to fund its Young Leaders Program and other advocacy work, as well as support the Women Deliver 2023 Conference (WD2023). The funding will help Young Leaders across the world to achieve their advocacy goals in gender equality and health through financial resources, mentorship, and technical assistance.

“The Board is committed to achieving both Organon’s business goals as well as contributing to societal goals, and to continuing to drive the company’s ESG strategy,” says Carrie Cox, Board Chairman. “We are pleased to be in a position to publish a comprehensive ESG report just one year after the company’s establishment as a standalone company and highlight our purpose and goals in improving the health of women and girls.”

The Board’s governance committee, called the ESG Committee, is comprised of five members and chaired by pharmaceutical industry veteran Robert Essner, all of whom bring considerable expertise from across a variety of disciplines.

For more details on Organon’s ESG strategy, priorities, and initiatives, download the full 2021 ESG Report at https://www.organon.com/about-organon/environmental-social-governance/.

About Organon

Organon is a global healthcare company with a focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in innovation and future growth opportunities in women’s health. 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 9,300 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn and Instagram.

Forward-Looking Statement of Organon

Organon makes various statements in this press release, including, but not limited to, statements about management’s expectations about Organon’s environmental, social, and governance strategy and goals. These “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. Organon 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 Organon’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, 2021 and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov).


Media:

Karissa Peer

(614) 314-8094

Kate Vossen

(732) 675-8448

Investors:

Jennifer Halchak

(201) 275-2711

Edward Barger

(267) 614-4669

Source: Organon & Co.

  • First quarter 2022 revenue of $1,567 million
  • Net income from continuing operations of $348 million, or $1.36 per diluted share; Adjusted net income from continuing operations of $420 million, or $1.65 per diluted share
  • Adjusted EBITDA of $647 million
  • Board of Directors declares quarterly dividend of $0.28 per share
  • Full year 2022 financial guidance ranges affirmed


Organon (NYSE: OGN) (the “company”), today announced its results for the first quarter ended March 31, 2022.

“The first quarter marked a solid start to the year. We continued to expand our Women’s Health offerings by acquiring the rights to Marvelon™ (ethinylestradiol, desogestrel) and Mercilon™ (ethinylestradiol, desogestrel) in certain markets, as well as by entering into a licensing agreement to commercialize XaciatoTM (clindamycin phosphate) vaginal gel,” said Kevin Ali, Organon’s CEO. “Additionally, with LOE risk in the Established Brands business largely behind us, together with continued focus on maximizing the potential of these well-known brands, we are starting to see the stability we knew was possible in that franchise.”


First quarter 2022 revenue

     

in $ millions

 

Q1 2022

 

 

Q1 2021

 

 

VPY

 

VPY ex-FX

Women’s Health

 

$

378

 

 

$

399

 

 

(5)%

 

(3)%

Biosimilars

 

 

99

 

 

 

81

 

 

22%

 

25%

Established Brands

 

 

1,053

 

 

 

957

 

 

10%

 

15%

Other (1)

 

 

37

 

 

 

69

 

 

(45)%

 

(46)%

Revenue

 

$

1,567

 

 

$

1,506

 

 

4%

 

8%


(1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties, and allocated amounts from pre-spin revenue hedging activities.

Total net revenue was $1,567 million for the first quarter of 2022, an increase of 4% as-reported and an increase of 8% excluding the impacts of foreign currency (ex-FX), compared with the first quarter of 2021.

Women’s Health declined 5% as-reported and declined 3% ex-FX in the first quarter 2022 compared with the first quarter of 2021, driven by Nuvaring® (etonogestrel/ethinyl estradiol vaginal ring) which declined 6% ex-FX in the first quarter of 2022 compared with the first quarter of 2021, and the Authorized Generic of Nuvaring (AG), both of which continue to be impacted by generic competition. The decline in the Women’s Health portfolio was also due to a 5% ex-FX decline in Nexplanon® (etonogestrel implant) which was driven by distributors’ buying patterns in the United States in prior periods, partially offset by strong performance in Latin America and volume growth in Europe. The decline in the company’s contraception portfolio was partially offset by double digit growth in the fertility franchise, led by Follistim AQ® (follitropin beta injection), which grew 20% ex-FX, primarily due to higher demand in China and volume growth in the United States.

Biosimilars revenue grew 22% as-reported and grew 25% ex-FX in the first quarter 2022 compared with first quarter 2021. Organon’s current portfolio includes certain immunology and oncology treatments. All five of the biosimilars in Organon’s portfolio have launched in certain countries globally, including two biosimilars, Renflexis® (infliximab-abda) and Ontruzant® (trastuzumab-dttb), in the United States. Renflexis grew 21% ex-FX in the first quarter of 2022 compared with the first quarter of 2021 primarily due to continued demand growth in the United States since its launch in 2017. Ontruzant grew 5% ex-FX driven by continued uptake in the United States since its launch in July 2020, partially offset by competitive pressures in Europe.

Established Brands represents a broad portfolio of well-known medicines, which are generally beyond market exclusivity, including leading brands in cardiovascular, respiratory, dermatology and non-opioid pain management, and for which generic competition varies by market. The portfolio’s exposure to loss of exclusivity (LOE) risk peaked in 2021 and no longer represents a significant impediment to stable performance in the Established Brands franchise. Revenue for Established Brands increased 10% as-reported and increased 15% ex-FX in the first quarter of 2022 compared with the first quarter of 2021. The first quarter of 2022 benefited from fluctuations in demand in certain markets, including a temporary supply issue currently impacting several competitors in the Japanese market. This compares to weaker performance in Japan in the first quarter of 2021 due to anticipated government-led price actions in that market and lingering effects from the LOE of Zetia® (ezetimibe). Additionally, the first quarter of last year was negatively impacted by the implementation of the third round of Volume Based Procurement (VBP) initiatives in China, as well as by LOE exposure. There was minimal impact from these factors in the first quarter of 2022. Volume growth in products in China, Europe and the LAMERA region also contributed to the favorable performance of Established Brands in the first quarter of 2022.


First quarter 2022 profitability

Organon was spun-off from Merck & Co., Inc., Rahway, NJ, USA on June 2, 2021. Financial results during the pre-spin period were presented on the carve-out basis of accounting and do not purport to reflect what Organon’s financial results would have been had Organon operated as a standalone public company. Therefore, with the exception of Revenue, financial results for the periods ending March 31, 2021 and March 31, 2022 are not meaningfully comparable.

in $ millions, except per share amounts

 

Q1 2022

 

Q1 2021

pre-spin

 

VPY

Revenue

 

$

1,567

 

 

$

1,506

 

 

4%

Cost of sales

 

 

561

 

 

 

591

 

 

(5)%

Gross profit

 

 

1,006

 

 

 

915

 

 

10%

Non-GAAP Adjusted gross profit (*)

 

 

1,042

 

 

 

937

 

 

11%

Adjusted EBITDA (*)

 

 

647

 

 

 

566

 

 

14%

Net Income, continuing operations (*)

 

 

348

 

 

 

395

 

 

(12)%

Non-GAAP Adjusted net income, continuing operations (*)

 

 

420

 

 

 

451

 

 

(7)%

Diluted Earnings per Share, continuing operations

 

 

1.36

 

 

 

1.56

 

 

(13)%

Non-GAAP Adjusted Diluted Earnings per Share, continuing operations (*)

 

 

1.65

 

 

 

1.78

 

 

(7)%

Gross margin

 

64.2%

 

60.8 %

 

Non-GAAP adjusted gross margin
(*)

 

66.5%

 

62.2 %

 

Adjusted EBITDA margin (*)

 

41.3%

 

37.6 %

 


(*) See Tables 4,5 and 6 for reconciliations of GAAP to non-GAAP financial measures

Gross margin was 64.2% as-reported and 66.5% on an adjusted basis in the first quarter of 2022 compared with 60.8% as-reported and 62.2% on an adjusted basis in the first quarter of 2021. The year-over-year improvement in gross margin primarily reflects reduced lower margin supply sales in the first quarter of this year.

Adjusted EBITDA margin was 41.3% in the first quarter of 2022 compared with 37.6% in the first quarter of 2021. The improvement in Adjusted EBITDA margin is largely driven by higher Adjusted gross profit in the period, and also reflects lower SG&A costs compared with the prior year, pre-spin period, partially offset by increased research and development costs in the first quarter of 2022 associated with the company’s recent acquisitions of clinical stage assets. Adjusted EBITDA margin in the first quarter of 2022 incorporates SG&A costs that are expected to be at the lowest point for full year 2022.

Net income from continuing operations for the first quarter of 2022 was $348 million, or $1.36 per diluted share, compared with $395 million, or $1.56 per diluted share, in the first quarter of 2021. Non-GAAP Adjusted net income from continuing operations was $420 million, or $1.65 per diluted share, compared with $451 million, or $1.78 per diluted share, in 2021.


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 June 16, 2022 to stockholders of record at the close of business on May 16, 2022.

As of March 31, 2022, cash and cash equivalents were $694 million, and debt was $9,094 million, resulting in net debt of $8,400 million.


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.

Beginning in 2022, Organon will no longer exclude expenses for upfront and milestone payments related to collaborations and licensing agreements, or charges related to pre-approval assets obtained in transactions accounted for as asset acquisitions from its non-GAAP results. These changes are being made to align with views expressed by the U.S. Securities and Exchange Commission. There are no such expenses or charges for in-process research and development for the periods ended March 31, 2022 or March 31, 2021. Relevant prior periods have been recast to reflect these changes and can be found in Tables 7 and 8 of this press release.

Organon’s financial guidance does not assume an estimate for future in-process research and development for business development transactions not yet executed.

The company affirmed the full year 2022 financial guidance previously provided on February 17, 2022, which is presented on a non-GAAP basis.

 

 

Previous guidance

 

Current guidance

Revenue

 

$6.1B – $6.4B

 

Unchanged

Adjusted gross margin

 

Mid 60%

 

Unchanged

SG&A as % of revenue

 

Mid 20%

 

Unchanged

R&D as % of revenue

 

Mid to upper single digit

 

Unchanged

Adjusted EBITDA margin

 

34%-36%

 

Unchanged

Interest

 

~$400 million

 

Unchanged

Depreciation

 

$100-$115 million

 

Unchanged

Effective Non-GAAP tax rate

 

17.5%-19.5%

 

Unchanged

Fully diluted weighted avg. shares outstanding

 

~255 million

 

Unchanged


Webcast Information

Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its first quarter 2022 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/. 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 using conference ID# 6895016 and by clicking on this link: http://www.directeventreg.com/registration/event/6895016. 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 through a spin-off from Merck & Co., Inc., Rahway, NJ, USA (NYSE: MRK) to focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in innovation and future growth opportunities in women’s health. 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 9,300 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn and Instagram.

Non-GAAP financial measures

This press release contains “non-GAAP financial measures,” which are financial measures that either exclude or include amounts that are 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 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. 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 the appendix 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 2022 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 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.

Forward-Looking Statement

Except for historical information herein, 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 execute on our business development strategy or realize the benefits of our planned acquisitions; general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; 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, 2021 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 share and per share amounts)

 

 

Three Months Ended March 31,

 

2022

 

 

2021

 

Revenues

$

1,567

 

 

$

1,506

 

Costs, Expenses and Other

 

 

 

 

Cost of sales

 

561

 

 

 

591

 

Selling, general and administrative

 

371

 

 

 

382

 

Research and development

 

96

 

 

 

67

 

Restructuring costs

 

 

 

 

1

 

Other (income) expense, net

 

97

 

 

 

(2

)

 

 

1,125

 

 

 

1,039

 

Income From Continuing Operations Before Income Taxes

 

442

 

 

 

467

 

Taxes on Income

 

94

 

 

 

72

 

Net Income From Continuing Operations

 

348

 

 

 

395

 

Income From Discontinued Operations – Net of Tax

 

 

 

 

4

 

Net Income

 

348

 

 

 

399

 

Earnings per Share Attributable to Organon & Co. Stockholders – Basic:

 

 

 

 

Continuing operations

$

1.37

 

 

$

1.56

 

Discontinued operations

 

 

 

 

0.02

 

Net Earnings per Share Attributable to Organon & Co. Stockholders

$

1.37

 

 

$

1.58

 

Earnings per Share Attributable to Organon & Co. Stockholders – Diluted:

 

 

 

 

Continuing operations

$

1.36

 

 

$

1.56

 

Discontinued operations

 

 

 

 

0.02

 

Net Earnings per Share Attributable to Organon & Co. Stockholders

$

1.36

 

 

$

1.58

 

Weighted Average Shares Outstanding:

 

 

 

 

Basic

 

253,583,000

 

 

 

253,516,000

 

Diluted

 

255,052,000

 

 

 

253,516,000

 

TABLE 2

 
   

Organon & Co.

Sales by top products

   

 

Three Months Ended March 31,

 

2022

 

2021

($ in millions)

U.S.

 

Int’l

 

Total

 

U.S.

 

Int’l

 

Total

Women’s Health

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nexplanon/Implanon NXT

$

116

 

 

$

55

 

 

$

171

 

 

$

141

 

 

$

42

 

 

$

183

 

Follistim AQ

 

30

 

 

 

31

 

 

 

61

 

 

 

25

 

 

 

27

 

 

 

52

 

NuvaRing

 

16

 

 

 

24

 

 

 

41

 

 

 

21

 

 

 

24

 

 

 

45

 

Ganirelix Acetate Injection

 

8

 

 

 

22

 

 

 

30

 

 

 

8

 

 

 

21

 

 

 

29

 

Cerazette

 

 

 

 

18

 

 

 

18

 

 

 

 

 

 

17

 

 

 

17

 

Other Women’s Health(1)

 

27

 

 

 

31

 

 

 

57

 

 

 

40

 

 

 

33

 

 

 

73

 

Biosimilars

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Renflexis

 

42

 

 

 

4

 

 

 

46

 

 

 

35

 

 

 

4

 

 

 

38

 

Ontruzant

 

7

 

 

 

15

 

 

 

22

 

 

 

4

 

 

 

19

 

 

 

22

 

Brenzys

 

 

 

 

14

 

 

 

14

 

 

 

 

 

 

10

 

 

 

10

 

Aybintio

 

 

 

 

10

 

 

 

10

 

 

 

 

 

 

8

 

 

 

8

 

Hadlima

 

 

 

 

6

 

 

 

6

 

 

 

 

 

 

2

 

 

 

2

 

Established Brands

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cardiovascular

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zetia

 

3

 

 

 

96

 

 

 

99

 

 

 

2

 

 

 

89

 

 

 

92

 

Vytorin

 

2

 

 

 

36

 

 

 

38

 

 

 

3

 

 

 

38

 

 

 

41

 

Atozet

 

 

 

 

119

 

 

 

119

 

 

 

 

 

 

112

 

 

 

112

 

Rosuzet

 

 

 

 

22

 

 

 

22

 

 

 

 

 

 

15

 

 

 

15

 

Cozaar/Hyzaar

 

8

 

 

 

86

 

 

 

93

 

 

 

3

 

 

 

87

 

 

 

90

 

Other Cardiovascular(1)

 

1

 

 

 

38

 

 

 

39

 

 

 

1

 

 

 

38

 

 

 

39

 

Respiratory

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Singulair

 

3

 

 

 

127

 

 

 

130

 

 

 

5

 

 

 

102

 

 

 

107

 

Nasonex

 

9

 

 

 

65

 

 

 

75

 

 

 

2

 

 

 

41

 

 

 

43

 

Dulera

 

31

 

 

 

9

 

 

 

40

 

 

 

31

 

 

 

8

 

 

 

38

 

Clarinex

 

1

 

 

 

37

 

 

 

38

 

 

 

1

 

 

 

23

 

 

 

25

 

Other Respiratory(1)

 

12

 

 

 

11

 

 

 

22

 

 

 

16

 

 

 

6

 

 

 

23

 

Non-Opioid Pain, Bone and Dermatology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Arcoxia

 

 

 

 

60

 

 

 

60

 

 

 

 

 

 

56

 

 

 

56

 

Fosamax

 

1

 

 

 

40

 

 

 

41

 

 

 

1

 

 

 

37

 

 

 

38

 

Diprospan

 

 

 

 

31

 

 

 

31

 

 

 

 

 

 

26

 

 

 

26

 

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

 

3

 

 

 

66

 

 

 

69

 

 

 

(1

)

 

 

62

 

 

 

61

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proscar

 

 

 

 

24

 

 

 

24

 

 

 

 

 

 

32

 

 

 

32

 

Propecia

 

1

 

 

 

29

 

 

 

30

 

 

 

2

 

 

 

29

 

 

 

31

 

Other(1)

 

8

 

 

 

74

 

 

 

83

 

 

 

11

 

 

 

78

 

 

 

89

 

Other (2)

 

 

 

 

37

 

 

 

37

 

 

 

 

 

 

69

 

 

 

69

 

Total Revenue

$

329

 

 

$

1,238

 

 

$

1,567

 

 

$

351

 

 

$

1,155

 

$

1,506

 
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. 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, and allocated amounts from pre-spin revenue hedging activities.

TABLE 3

 
   

Organon & Co.

Sales by geographic area

(Unaudited, $ in millions)

   

 

Three Months Ended March 31,

($ in millions)

2022

 

2021

Europe and Canada

$

436

 

 

$

434

 

United States

 

329

 

 

 

351

 

Asia Pacific and Japan

 

314

 

 

 

278

 

China

 

236

 

 

 

206

 

Latin America, Middle East, Russia and Africa

 

209

 

 

 

167

 

Other (1)

 

43

 

 

 

70

 

Revenue

$

1,567

 

 

$

1,506

 

(1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties, and allocated amounts from pre-spin revenue hedging activities.

TABLE 4

 

Reconciliation of GAAP Gross Margin to Non-GAAP Adjusted Gross Profit and Adjusted Gross Margin

($ in millions)

 

 

Three Months Ended March 31,

 

 

2022

 

 

 

2021

 

Revenue

$

1,567

 

 

$

1,506

 

Cost of sales

 

561

 

 

 

591

 

Gross Profit

 

1,006

 

 

 

915

 

Gross Margin

 

64.2

%

 

 

60.8

%

Amortization

 

28

 

 

 

20

 

One-time costs (1)

 

5

 

 

 

 

Stock-based compensation

 

3

 

 

 

2

 

Non-GAAP Adjusted Gross Profit
(2)

$

1,042

 

 

$

937

 


Non-GAAP Adjusted Gross Margin

 


66.5


%

 

 


62.2


%


(1) One-time costs for the three months ended March 31, 2022 primarily include costs to stand up the Company.

(2) Non-GAAP Adjusted Gross Profit is calculated by excluding amortization, one-time costs, and the portion of stock-based compensation expense allocated to Cost of sales.

TABLE 5

 

Organon & Co.

Reconciliation of GAAP Income from Continuing Operations Before Income Taxes to Adjusted EBITDA

($ in millions)

 

Three Months Ended March 31,

 

 

2022

 

 

 

2021

 

Income from continuing operations before income taxes

$

442

 

 

$

467

 

Depreciation

 

25

 

 

 

18

 

Amortization (1)

 

28

 

 

 

20

 

Interest expense

 

97

 

 

 

 

EBITDA

 

592

 

 

 

505

 

Restructuring costs

 

 

 

 

1

 

One-time costs (2)

 

40

 

 

 

49

 

Acquired in-process research and development

 

 

 

 

 

Stock-based compensation

 

15

 

 

 

11

 

Adjusted EBITDA

$

647

 

 

$

566

 


Adjusted EBITDA margin

 

41.3

%

 

 

37.6

%


(1) Amortization in all periods is included in Cost of sales.

(2) One-time costs primarily include costs incurred in connection with the spin-off of Organon. For the three months ended March 31, 2022, approximately $25 million of the one-time costs are recorded in Selling, general and administrative expenses, $6 million are recorded in Other (income) expense, $5 million are recorded in Cost of sales, and $4 million are recorded in Research and development. For the three months ended March 31, 2021, $49 million of the one-time costs are classified in Selling, general and administrative expenses.

TABLE 6

 
   

Organon & Co.

Reconciliation of GAAP Income from Continuing Operations Before Income Taxes to Non-GAAP Adjusted Net Income

($ in millions, except per share amounts)

 

 

Three Months Ended March 31,

 

 

2022

 

 

 

2021

 

Income from continuing operations before income taxes

$

442

 

 

$

467

 

Adjustments:

 

 

 

 

Amortization (1)

 

28

 

 

 

20

 

Restructuring costs

 

 

 

 

1

 

One-time costs (2)

 

40

 

 

 

49

 

Acquired in-process research and development

 

 

 

 

 

Stock-based compensation

 

15

 

 

 

11

 

Total Adjustments

 

83

 

 

 

81

 

Non-GAAP pre-tax income from continuing operations

 

525

 

 

 

548

 

Taxes on income as reported in accordance with GAAP

 

94

 

 

 

72

 

Tax benefit on adjustments

 

14

 

 

 

15

 

Tax (deduction)/benefit on GAAP-only discrete items

 

(3

)

 

 

10

 

Non-GAAP adjusted taxes on income

 

105

 

 

 

97

 

Non-GAAP adjusted net income, continuing operations

 

420

 

 

 

451

 

Non-GAAP adjusted net income, continuing operations per diluted share

$

1.65

 

 

$

1.78

 

(1) Amortization in all periods is included in Cost of sales.

(2)

One-time costs primarily include costs incurred in connection with the spin-off of Organon. For the three months ended March 31, 2022, approximately $25 million of the one-time costs are recorded in Selling, general and administrative expenses, $6 million are recorded in Other (income) expense, $5 million are recorded in Cost of sales, and $4 million are recorded in Research and development. For the three months ended March 31, 2021, $49 million of the one-time costs are classified in Selling, general and administrative expenses.

TABLE 7

 

Organon & Co.

Reconciliation of GAAP Income from Continuing Operations Before Income Taxes to Adjusted EBITDA

($ in millions)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Q1 2021

 

Q2 2021

 

Q3 2021

 

Q4 2021

 

FY 2021

 

As

Reported

and

Recast (4)

 

As

Reported

and

Recast (4)

 

As

Reported

 

Impact of

Non-

GAAP

Reporting

Changes

 

Recast

 

As

Reported

 

Impact of

Non-

GAAP

Reporting

Changes

 

Recast

 

As

Reported

 

Impact of

Non-

GAAP

Reporting

Changes

 

Recast

Income from continuing operations before income taxes

$

467

 

$

437

 

$

389

 

$

 

 

$

389

 

$

236

 

$

 

 

$

236

 

$

1,529

 

$

 

 

$

1,529

Depreciation

 

18

 

 

21

 

 

25

 

 

 

 

 

25

 

 

28

 

 

 

 

 

28

 

 

92

 

 

 

 

 

92

Amortization (1)

 

20

 

 

22

 

 

27

 

 

 

 

 

27

 

 

34

 

 

 

 

 

34

 

 

103

 

 

 

 

 

103

Interest expense

 

 

 

62

 

 

98

 

 

 

 

 

98

 

 

98

 

 

 

 

 

98

 

 

258

 

 

 

 

 

258

EBITDA

$

505

 

$

542

 

$

539

 

$

 

 

$

539

 

$

396

 

$

 

 

$

396

 

$

1,982

 

$

 

 

$

1,982

Restructuring costs

 

1

 

 

1

 

 

1

 

 

 

 

 

1

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

3

One-time costs (2)

 

49

 

 

66

 

 

56

 

 

 

 

 

56

 

 

59

 

 

 

 

 

59

 

 

231

 

 

 

 

 

231

Acquired in-process research and development (3)

 

 

 

 

 

25

 

 

(25

)

 

 

 

 

79

 

 

(79

)

 

 

 

 

104

 

 

(104

)

 

 

Stock-based compensation

 

11

 

 

18

 

 

15

 

 

 

 

 

15

 

 

15

 

 

 

 

 

15

 

 

59

 

 

 

 

 

59

Adjusted EBITDA

$

566

 

$

627

 

$

636

 

$

(25

)

 

$

611

 

$

549

 

$

(79

)

 

$

470

 

$

2,379

 

$

(104

)

 

$

2,275


(1) Amortization in all periods is included in Cost of sales.


(2)

One-time costs primarily include costs incurred in connection with the spin-off of Organon as well as acquisition related costs. Refer to the Company’s previously filed Current Reports on Form 8-K for a further description of these costs for each reported period.


(3) Costs represent upfront licensing payment associated with ObsEva of $25 million during the third quarter of 2021 and Forendo of $79 million in the fourth quarter of 2021, which were recorded in Research and development expense.


(4) The change does not affect the previously reported Adjusted EBITDA results for the first and second quarter of 2021 as there were no adjustments which affected either of the periods.

TABLE 8

 

Organon & Co.

Reconciliation of GAAP Income from Continuing Operations Before Income Taxes to Non-GAAP Adjusted Net Income

($ in millions, except per share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Q1 2021

 

Q2 2021

 

Q3 2021

 

Q4 2021

 

FY 2021

 

As

Reported

and

Recast (5)

 

As

Reported

and

Recast (5)

 

As

Reported

 

Impact of

Non-

GAAP

Reporting

Changes

 

Recast

 

As

Reported

 

Impact of

Non-

GAAP

Reporting

Changes

 

Recast

 

As

Reported

 

Impact of

Non-

GAAP

Reporting

Changes

 

Recast

Income from continuing operations before income taxes

$

467

 

$

437

 

$

389

 

$

 

 

$

389

 

$

236

 

$

 

 

$

236

 

$

1,529

 

$

 

 

$

1,529

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization (1)

 

20

 

 

22

 

 

27

 

 

 

 

 

27

 

 

34

 

 

 

 

 

34

 

 

103

 

 

 

 

 

103

Restructuring costs

 

1

 

 

1

 

 

1

 

 

 

 

 

1

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

3

One-time costs (2)

 

49

 

 

66

 

 

56

 

 

 

 

 

56

 

 

59

 

 

 

 

 

59

 

 

231

 

 

 

 

 

231

Acquired in-process research and development (3)

 

 

 

 

 

25

 

 

(25

)

 

 

 

 

79

 

 

(79

)

 

 

 

 

104

 

 

(104

)

 

 

Stock-based compensation

 

11

 

 

18

 

 

15

 

 

 

 

 

15

 

 

15

 

 

 

 

 

15

 

 

59

 

 

 

 

 

59

Total Adjustments

 

81

 

 

107

 

 

124

 

 

(25

)

 

 

99

 

 

187

 

 

(79

)

 

 

108

 

 

500

 

 

(104

)

 

 

396

Non-GAAP pre-tax income from continuing operations

$

548

 

$

544

 

$

513

 

$

(25

)

 

$

488

 

$

423

 

$

(79

)

 

$

344

 

$

2,029

 

$

(104

)

 

$

1,925

Taxes on income as reported in accordance with GAAP

 

72

 

 

6

 

 

66

 

 

 

 

 

66

 

 

34

 

 

 

 

 

34

 

 

178

 

 

 

 

 

178

Tax benefit on adjustments

 

15

 

 

20

 

 

23

 

 

(2

)

 

 

21

 

 

35

 

 

(17

)

 

 

18

 

 

93

 

 

(19

)

 

 

74

Tax benefit on GAAP-only discrete items (4)

 

10

 

 

81

 

 

 

 

 

 

 

 

 

5

 

 

 

 

 

5

 

 

96

 

 

 

 

 

96

Non-GAAP adjusted taxes on income

$

97

 

$

107

 

$

89

 

$

(2

)

 

$

87

 

$

74

 

$

(17

)

 

$

57

 

$

367

 

$

(19

)

 

$

348

Non-GAAP adjusted net income, continuing operations

$

451

 

$

437

 

$

424

 

$

(23

)

 

$

401

 

$

349

 

$

(62

)

 

$

287

 

$

1,662

 

$

(85

)

 

$

1,577

Non-GAAP adjusted net income from continuing operations per diluted share

$

1.78

 

$

1.72

 

$

1.67

 

$

(0.09

)

 

$

1.58

 

$

1.37

 

$

(0.24

)

 

$

1.13

 

$

6.54

 

$

(0.33

)

 

$

6.20


(1) Amortization in all periods is included in Cost of sales.


(2)

One-time costs primarily include costs incurred in connection with the spin-off of Organon as well as acquisition related costs. Refer to the Company’s previously filed Form 8-Ks for a further description of these costs for each reported period.


(3) Costs represent upfront licensing payment associated with ObsEva of $25 million during the third quarter of 2021 and Forendo of $79 million in the fourth quarter of 2021, which were recorded in Research and development expense.


(4) Amounts include a tax benefit of approximately $70 million recorded in the second quarter of 2021 and a tax benefit of $5 million recorded in the fourth quarter of 2021 related to a portion of non-US step up in tax basis as a result of its separation from Merck & Co., Inc., Rahway, NJ, USA.


(5) The change does not affect the previously reported Non-GAAP results for the first and second quarter of 2021 as there were no adjustments which affected either of the periods.

 


Media Contacts:

Karissa Peer

(614) 314-8094

Kate Vossen

(732) 675-8448

Investor Contacts:

Jennifer Halchak

(201) 275-2711

Edward Barger

(267) 614-4669

Source: Organon & Co.


Organon (NYSE: OGN), will release its first quarter 2022 financial results on May 5, 2022, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT.

Interested parties may access the live call via webcast on the Organon 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 using conference ID# 6895016 and by clicking on this link: http://www.directeventreg.com/registration/event/6895016. Following registration, participants will receive a confirmation email containing details on how to join the conference call, including dial-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 through a spin-off from Merck & Co., Inc., Rahway, NJ, USA, (NYSE: MRK) known as MSD outside of the United States and Canada, to focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in innovation and future growth opportunities in women’s health. 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 9,300 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn and Instagram.


Media:

Karissa Peer

(614) 314-8094

Kate Vossen

(732) 675-8448

Investor:

Jennifer Halchak

(201) 275-2711

Edward Barger

(267) 614-4669

Source: Organon & Co.

An estimated 21 million American women experience BV


Organon (NYSE: OGN), a global women’s healthcare company, and Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced they have entered into an agreement whereby Organon will license global rights to XACIATO (clindamycin phosphate vaginal gel, 2%). XACIATO is an FDA-approved medication for the treatment of bacterial vaginosis (BV) in females 12 years of age and older. XACIATO received both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA for the treatment of bacterial vaginosis.

“Our agreement with Daré aligns well with our long-term growth strategy focused on delivering new options for women where therapeutic gaps exist,” said Kevin Ali, Organon’s Chief Executive Officer. “Organon will bring its commercial expertise to this collaboration so that we can deliver this option to women, specifically in a condition like bacterial vaginosis where more treatment choices are needed.”

BV is the most common cause of vaginitis worldwide and is estimated to affect approximately 21 million women in the U.S. The condition results from an overgrowth of bacteria, which upsets the balance of the natural vaginal microbiome and can lead to symptoms of odor and discharge.

Sabrina Martucci Johnson, Daré’s President and Chief Executive Officer, commented, “Organon shares our commitment to advance critically needed innovations in women’s health. We are excited to be collaborating with one of the premier companies in women’s health as we believe that Organon’s commercial capabilities will ensure that XACIATO reaches the women most impacted by this condition.”

Daré will receive a $10 million upfront payment from Organon. Daré is eligible to receive potential milestone payments of up to $182.5 million and tiered double-digit royalties based on net sales. XACIATO is expected to be available commercially in the U.S. in Q4 2022. Completion of the transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in Q2 2022.

About Organon

Organon is a global healthcare company formed through a spin-off from Merck & Co., Inc., Rahway, NJ, USA, (NYSE: MRK) known as MSD outside of the United States and Canada, to focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in innovation and future growth opportunities in women’s health. 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 9,300 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn and Instagram.

About Daré Bioscience

Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women’s health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual health.

For more information, visit http://www.darebioscience.com, and follow these Twitter accounts: @SabrinaDareCEO and @DareBioscience.

Forward-Looking Statement of Organon

Except for historical information herein, this news 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 XACIATO as a potential treatment for BV, Organon’s and Daré’s ability to improve the lives of women, Organon’s ability to deliver new therapeutic options for women, and the potential benefits of the licensing agreement with Daré. Forward-looking statements may be identified by words such as “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will” or words of similar meaning. Such statements are based upon the current beliefs and expectations of the Organon’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, general industry conditions and competition; general economic factors; 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 approvals; the Organon’s ability to accurately predict its future financial results and performance; Organon’s ability to accurately predict future market conditions; 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.

Organon 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 Organon’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K, filed on March 21, 2022, available at the SEC’s Internet site (www.sec.gov).

Forward-Looking Statements of Daré Bioscience

Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “will,” “estimate,” “believe,” “expect,” “eligible,” “anticipate,” “plan,” “seek,” “potential,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to Daré’s expectations about its agreement with Organon, including commercial distribution and sale of XACIATO and receipt of payments from Organon, and the expected timing of commercial availability of XACIATO in the United States. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements in this press release, including, without limitation: the risks that closing conditions required for the agreement with Organon to become fully effective may not be satisfied or waived and that the agreement may not become fully effective or may be terminated early and the upfront payment may not become payable; the risk that none of the milestones under the agreement with Organon may be achieved and none of potential milestone payments become payable; the potential for royalty payments to be subject to reductions and offsets; dependence on Organon to commercialize the licensed products and on other third parties for commercial supplies of licensed products and components and Daré’s lack of control over the efforts and resources expended by those third parties; general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; 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; Daré’s ability to accurately predict its future financial condition, operating results and performance; Daré’s or its licensor’s ability to accurately predict future market conditions; third-party 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 patents owned or licensed by Daré and other protections for innovative products; and the exposure of Daré, its commercial counterparties and other third parties on which it relies to litigation, including patent litigation, and/or regulatory actions. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.


Organon Media:

Karissa Peer

(614) 314-8094

Kate Vossen

(732) 675-8448

Daré Media:

Jake Robison

(619) 849-5383

Organon Investor

Jennifer Halchak

(201) 275-2711

Edward Barger

(267) 614-4669

Daré Investor:

Lee Roth

(212) 213-0006

Source: Organon & Co.


Organon (NYSE: OGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the Cowen 42nd Annual Healthcare Virtual Conference on Wednesday, March 9, 2022 at 9:10 a.m. EST.

Investors, analysts, members of the media and the general public are invited to watch to a live video webcast of the presentation at https://www.organon.com/investor-relations/events-and-presentations/.

About Organon

Organon is a global healthcare company formed through a spin-off from Merck, (NYSE: MRK) known as MSD outside of the United States and Canada, to focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in innovation and future growth opportunities in women’s health. 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 9,500 employees with headquarters located in Jersey City, New Jersey.

For more information, visit https://www.organon.com and connect with us on LinkedIn and Instagram.


Media Contacts:

Karissa Peer

(614) 314-8094

Kate Vossen

(732) 675-8448

Investor Contacts:

Jennifer Halchak

(201) 275-2711

Edward Barger

(267) 614-4669

Source: Organon & Co.


Organon (NYSE: OGN), a global women’s health company, today announced the appointment of Meghan Rivera as US Managing Director. With over 20 years of commercial experience in bio-pharmaceutical organizations and digital therapeutics, Ms. Rivera will be responsible for leading Organon’s 400-strong US Commercial Operations team, maximizing growth potential across the company’s portfolio of women’s health, biosimilars, and established brands treatment areas.

Ms. Rivera has significant commercial experience including roles in bio-pharmaceutical and digital therapeutic organizations and agency partners. She has extensive women’s health expertise, having held leadership roles in commercial and general management. Most recently she was Chief Marketing Officer and Head of Commercial, Akili Interactive. She previously worked at AMAG Pharmaceuticals with responsibility for the women’s health business unit and at Boehringer Ingelheim where she led the team responsible for customer engagement activities. She holds a Bachelor of Science, Business Management, at the University of Atlanta as well as a Certification in Corporate Finance and Accounting at the Columbia Business School.

Susanne Fiedler, Chief Commercial Officer, Organon, stated “I am delighted to welcome Meghan to Organon and know that she will be an inspiring leader for our US operations. With her strong track record and focus on execution of commercial strategies, she is ideally placed to provide the strategic direction to enable our teams to realize our vision of delivering a better and healthier every day for every woman.”

Ms. Rivera commented “I am thrilled to join Organon at such an exciting point of the company’s journey. From my experience working with transformational companies and across the women’s health sector, I know that our US commercial operations have significant potential for growth and development. I look forward to leading and learning from this experienced, innovative and collaborative team, ensuring we maximize the potential of our strong portfolio of pharmaceutical products and medical devices as we set up this one-of-a-kind company.”

About Organon

Organon is a global healthcare company formed through a spin-off from Merck, (NYSE: MRK) known as MSD outside of the United States and Canada, to focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in innovation and future growth opportunities in women’s health. 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 9,500 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn and Instagram.


Media:

Karissa Peer, (614) 314-8094

Source: Organon & Co.