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.


Nexplanon
® (etonogestrel implant), fertility, biosimilars grew double digits for full year

  • Full year 2021 revenue of $6.3 billion
  • Income from continuing operations before tax of $1.5 billion for full year 2021
  • Full year Adjusted EBITDA of $2.4 billion
  • Company executing on business development; four transactions since spin
  • Full year 2022 financial guidance provided; revenue range of $6.1 billion to $6.4 billion and Adjusted EBITDA margins in the range of 34%-36%


Organon (NYSE: OGN) today announced its results for the fourth quarter and full year ended December 31, 2021.

Organon also announced that its Board of Directors declared a quarterly dividend of $0.28 for each issued and outstanding share of the company’s common stock. The dividend is payable on March 17, 2022 to stockholders of record at the close of business on February 28, 2022.

“In 2021 we delivered on our financial objectives across the board. Organon has taken significant steps to advance our vision to become a leader in women’s health through meaningful business development that addresses areas of significant unmet need for women and society,” said Kevin Ali, Organon’s CEO. “We continue to balance our growth objectives against our commitment to lower leverage, and in the fourth quarter we repaid $100 million of our term loans. Overall, we are well positioned as we head into 2022.”


Fourth quarter 2021 revenue

in $ millions

 

Q4 2021

 

Q4 2020

 

VPY

 

VPY ex-FX

Women’s Health

 

$

415

 

$

390

 

6

%

 

6

%

Biosimilars

 

 

118

 

 

103

 

15

%

 

14

%

Established Brands

 

 

1,037

 

 

1,062

 

(2

)%

 

(2

)%

Other(1)

 

 

34

 

 

58

 

(42

)%

 

(70

)%

Revenue

 

$

1,604

 

$

1,613

 

(1

)%

 

(1

)%

(1)
Other includes manufacturing sales to Merck & Co., Inc.(“Merck”) and other third parties, and allocated amounts from pre-spin revenue hedging activities through the date of separation.

Total net revenue was $1,604 million for the fourth quarter of 2021, a decrease of 1%, both as-reported and excluding the impacts of foreign currency (ex-FX), compared with fourth quarter of 2020. Strong sales for Nexplanon, together with growth in biosimilars were offset by declines in Established Brands and supply sales to Merck and other third parties.

Women’s Health increased 6% both as-reported and ex-FX in the fourth quarter 2021 compared with the fourth quarter of 2020 driven primarily by Nexplanon, which increased 37% ex-FX in the fourth quarter 2021 compared with the fourth quarter of 2020. Nexplanon’s growth in the quarter was due to increased demand in the United States, as well as tenders won, which can be variable quarter to quarter. The increase in Women’s Health was partially offset by a decline in sales of Nuvaring® (etonogestrel/ethinyl estradiol vaginal ring) which continues to be impacted by generic competition.

Biosimilars revenue grew 15% as-reported and 14% ex-FX in the fourth quarter 2021 compared with fourth quarter 2020, driven by continued growth in the United States for Renflexis® (infliximab-abda) and growth in Canada. The biosimilars portfolio also benefited from the continued uptake of Ontruzant® (trastuzumab-dttb) in the United States, partially offset by a decrease in the European Union, due to increasing competitive pressures, and Latin America, due to the timing of tenders in Brazil.

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. In 2021, declines related to loss of exclusivity (LOE) moderated, and in the fourth quarter the franchise was down 2% on both a nominal and constant currency basis. The decline in Established Brands during the fourth quarter of 2021 compared to the fourth quarter of 2020 was primarily due to a terminated agreement in Korea for Rosuzet™ (ezetimibe, rosuvastatin as calcium), loss of exclusivity for Zetia® (ezetimibe) in Japan in June 2020, the negative impact of Volume Based Procurement (VBP) in China, which was partially offset by growth in the retail channel and brands not impacted by VBP, as well as growth of Atozet™ (ezetimibe and atorvastatin calcium trihydrate) and certain products in the respiratory and non-opioid pain franchises.


Fourth quarter 2021 profitability

in $ millions, except per share amounts

 

Q4 2021

 

Q4 2020

 

VPY

Revenue

 

$

1,604

 

 

$

1,613

 

 

(1

)%

Cost of sales

 

 

599

 

 

 

586

 

 

2

%

Gross profit

 

 

1,005

 

 

 

1,027

 

 

(2

)%

Gross margin

 

 

62.7

%

 

 

63.7

%

 

 

Non-GAAP adjusted gross profit(*)

 

 

1,059

 

 

 

1,051

 

 

1

%

Non-GAAP adjusted gross margin

 

 

66.0

%

 

 

65.2

%

 

 

Adjusted EBITDA(*)

 

 

549

 

 

 

680

 

 

(19

)%

Adjusted EBITDA margin

 

 

34.2

%

 

 

42.2

%

 

 

Net Income, continuing operations

 

 

202

 

 

 

376

 

 

(46

)%

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

 

 

349

 

 

 

494

 

 

(29

)%

Diluted Earnings per Share, continuing operations

 

 

0.79

 

 

 

1.48

 

 

(47

)%

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

 

 

1.37

 

 

 

1.95

 

 

(30

)%

 

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

Gross margin was 62.7% as-reported and 66.0% on an adjusted basis in the fourth quarter of 2021 compared with 63.7% as-reported and 65.2% on an adjusted basis in the fourth quarter of 2020.

Adjusted EBITDA margin was 34.2% in the fourth quarter of 2021 compared with 42.2% in the fourth quarter of 2020. The decline reflects costs incurred to establish Organon as a stand-alone entity.

Net income from continuing operations for the fourth quarter of 2021 was $202 million, or $0.79 per diluted share, compared with $376 million, or $1.48 per diluted share, in the fourth quarter of 2020. Non-GAAP Adjusted net income from continuing operations was $349 million, or $1.37 per diluted share, compared with $494 million, or $1.95 per diluted share, in 2020.


2021 revenue

in $ millions

 

FY 2021

 

FY 2020

 

VPY

 

VPY ex-FX

Women’s Health

 

$

1,612

 

$

1,555

 

4

%

 

2

%

Biosimilars

 

 

424

 

 

330

 

28

%

 

25

%

Established Brands

 

 

4,068

 

 

4,540

 

(10

)%

 

(13

)%

Other(1)

 

 

200

 

 

107

 

87

%

 

67

%

Revenue

 

$

6,304

 

$

6,532

 

(3

)%

 

(6

)%

(1)
Other includes manufacturing sales to Merck and other third parties, and allocated amounts from pre-spin revenue hedging activities through the date of separation.

Total net revenue was $6,304 million for full year 2021, a decrease of 3% as-reported and 6% ex-FX, compared with 2020. The sales decline reflects decreases across certain markets within the Established Brands business, primarily due to ongoing competition after loss of exclusivity. The overall sales decline was offset by higher sales of Women’s Health products, notably Nexplanon, Follistim AQ® (follitropin beta injection) and ganirelix acetate injection due to increasing demand, higher sales of biosimilars resulting from the continued uptake of Renflexis and Ontruzant in the United States, and the favorable impact of foreign exchange.

Women’s Health increased 4% as-reported and 2% ex-FX for full year 2021 compared with 2020, driven by Nexplanon which increased 12% ex-FX in 2021. This was partially offset by a 21% ex-FX decline in Nuvaring which continues to be impacted by generic competition, and by declining sales in the United States of the authorized generic of Nuvaring. Follistim AQ (marketed in most countries outside the United States as Puregon™), a fertility treatment, increased 19% ex-FX in 2021 compared with 2020, primarily due to volume growth, as well as recovery from the COVID-19 pandemic in the United States and China.

Biosimilars revenue grew 28% as-reported and 25% ex-FX for full year 2021 compared with 2020, driven by continued growth in the United States for Renflexis and growth in Canada. The biosimilars portfolio also benefited from the launch of Hadlima® (adalimumab-bwwd) and Aybintio® (bevacizumab) in certain ex-US markets during the year, and the continued uptake of Ontruzant in the United States, partially offset by revenue declines in the European Union due to increasing competitive pressures.

Revenue for Established Brands was down 10% as-reported and down 13% ex-FX for the full year 2021, primarily driven by the impact of the loss of exclusivity of Zetia in Japan in June 2020. Excluding the impact of the loss of exclusivity, Established Brands revenue was down 8% ex-FX. Additionally, during 2021, the Established Brands portfolio in China was subject to the negative impact of the third round of VBP, the largest so far for Organon. The associated decline was partially offset by growth in brands in the hospital channel not impacted by VBP, the partial recovery of the respiratory market as well as growth in the retail segment which accounts for approximately 50% of the total sales of Established Brands in China.


Full year 2021 profitability

in $ millions, except per share amounts

 

 

2021

 

 

 

2020

 

 

VPY

Revenue

 

$

6,304

 

 

$

6,532

 

 

(3

)%

Cost of sales

 

 

2,382

 

 

 

2,119

 

 

12

%

Gross profit

 

 

3,922

 

 

 

4,413

 

 

(11

)%

Gross margin

 

 

62.2

%

 

 

67.6

%

 

 

Non-GAAP adjusted gross profit(*)

 

 

4,081

 

 

 

4,516

 

 

(10

)%

Non-GAAP adjusted gross margin

 

 

64.7

%

 

 

69.1

%

 

 

Adjusted EBITDA(*)

 

 

2,379

 

 

 

3,120

 

 

(24

)%

Adjusted EBITDA margin

 

 

37.7

%

 

 

47.8

%

 

 

Net Income, continuing operations

 

 

1,351

 

 

 

2,256

 

 

(40

)%

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

 

 

1,662

 

 

 

2,523

 

 

(34

)%

Diluted Earnings per Share, continuing operations

 

 

5.31

 

 

 

8.90

 

 

(40

)%

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

 

 

6.54

 

 

 

9.95

 

 

(34

)%

 

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

Gross margin was 62.2% as-reported and 64.7% on an adjusted basis for full year 2021 compared with 67.6% as-reported and 69.1% on an adjusted basis in 2020. The year-over-year decrease reflects costs of establishing Organon as an independent company, including certain costs related to manufacturing agreements between the company and its former parent company, which have lower gross margin percentages compared to third party product sales and purchases.

Adjusted EBITDA margin was 37.7% for 2021 compared with 47.8% in 2020, which reflects costs incurred to establish Organon as a stand-alone entity.

Net income from continuing operations for 2021 was $1,351 million, or $5.31 per diluted share, compared with $2,256 million, or $8.90 per diluted share in 2020. Non-GAAP Adjusted net income from continuing operations was $1,662 million, or $6.54 per diluted share, compared with $2,523 million, or $9.95 per diluted share in 2020.


Capital allocation

Today, Organon’s Board of Directors declared a quarterly dividend of $0.28 for each issued and outstanding share of the company’s common stock. The dividend is payable on March 17, 2022 to stockholders of record at the close of business on February 28, 2022.

As of December 31, 2021, cash and cash equivalents were $737 million, and gross debt was $9,134 million, resulting in net debt of $8,397 million. Total debt as of December 31, 2021 reflects a discretionary fourth quarter prepayment of $100 million on the company’s term loans.


Full year guidance – all guidance provided on a Non-GAAP basis

Organon does not provide GAAP financial measures (other than revenue) on a forward-looking basis because the company is unable to predict with reasonable certainty and without unreasonable effort, items such as, the ultimate outcome of legal proceedings, unusual gains and losses, 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 provided financial guidance for full year 2022, which is presented on a non-GAAP basis.

Non-GAAP basis (except revenue)

 

 

Guidance

Revenue

 

 

$6.1B – $6.4B

Adjusted gross margin

 

 

Mid 60%

SG&A as % of sales

 

 

Mid 20%

R&D as % of sales

 

 

Mid to upper single digit

Adjusted EBITDA margin

 

 

34%-36%

Interest expense

 

 

~$400 million

Depreciation

 

 

$100-$115 million

Effective Non-GAAP tax rate

 

 

17.5%-19.5%

Fully diluted weighted avg. shares outstanding

 

 

~255 million


Webcast Information

Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its fourth quarter and full year 2021 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#2682555 and by clicking on this link: http://www.directeventreg.com/registration/event/2682555. 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, (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.

Non-GAAP financial measures

Non-GAAP results, such as Adjusted EBITDA, Adjusted Net Income, and Adjusted Diluted EPS, are presented only as a supplement to the company’s financial statements based on GAAP. Non-GAAP financial information is provided to enhance understanding of the company’s financial performance, but none of these non-GAAP financial measures are recognized terms under GAAP, and non-GAAP measures should not be considered in isolation from, or as a substitute analysis for, the company’s results of operations as determined in accordance with GAAP. Definitions and reconciliations of non-GAAP measures to the most directly comparable GAAP measures are provided within the schedules attached to this release. The company uses non-GAAP 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. The company also believes that investors may find non-GAAP financial measures useful for the same reasons, although investors are cautioned that non-GAAP financial measures are not a substitute for GAAP disclosures. The non-GAAP financial measures are not presented in accordance with GAAP. Please refer to the appendix of this press release for reconciliations of non-GAAP financial measures contained herein to the most directly comparable GAAP measures. 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.

Forward-Looking Statements

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 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; the company’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.

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 its registration statement on Form 10 and subsequent periodic 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 December 31,

 

Twelve Months Ended December 31,

 

 

2021

 

 

2020

 

 

 

2021

 

 

2020

 

Revenues

$

1,604

 

$

1,613

 

 

$

6,304

 

$

6,532

 

Costs, Expenses and Other

 

 

 

 

 

 

 

Cost of sales

 

599

 

 

586

 

 

 

2,382

 

 

2,119

 

Selling, general and administrative

 

481

 

 

434

 

 

 

1,668

 

 

1,356

 

Research and development

 

189

 

 

60

 

 

 

443

 

 

210

 

Restructuring costs

 

 

 

17

 

 

 

3

 

 

60

 

Other (income) expense, net

 

99

 

 

(9

)

 

 

279

 

 

35

 

 

 

1,368

 

 

1,088

 

 

 

4,775

 

 

3,780

 

Income From Continuing Operations Before Income Taxes

 

236

 

 

525

 

 

 

1,529

 

 

2,752

 

Taxes on Income

 

34

 

 

149

 

 

 

178

 

 

496

 

Net Income From Continuing Operations

 

202

 

 

376

 

 

 

1,351

 

 

2,256

 

Loss From Discontinued Operations – Net of Tax

 

 

 

(8

)

 

 

 

 

(96

)

Net Income

$

202

 

$

368

 

 

 

1,351

 

 

2,160

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

Continuing operations

 

0.80

 

 

1.48

 

 

 

5.33

 

 

8.90

 

Discontinued operations

 

 

 

(0.03

)

 

 

 

 

(0.38

)

Net Earnings per Share Attributable to Organon & Co. Stockholders

 

0.80

 

 

1.45

 

 

 

5.33

 

 

8.52

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

Continuing operations

 

0.79

 

 

1.48

 

 

$

5.31

 

$

8.90

 

Discontinued operations

 

 

 

(0.03

)

 

$

 

$

(0.38

)

Net Earnings per Share Attributable to Organon & Co. Stockholders

 

0.79

 

 

1.45

 

 

$

5.31

 

$

8.52

 

 

 

 

 

 

 

 

 

Weighted Average Shares Outstanding:

 

 

 

 

 

 

 

Basic

 

253,549,167

 

 

253,516,000

 

 

 

253,537,941

 

 

253,516,000

 

Diluted

 

254,550,738

 

 

253,516,000

 

 

 

254,192,700

 

 

253,516,000

 

TABLE 2

Organon & Co.

Sales by top products

 

 

Three Months Ended December 31,

 

Twelve Months Ended December 31,

 

2021

 

2020

 

2021

 

2020

($ 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

$

143

 

 

$

83

 

$

226

 

$

114

 

$

50

 

$

165

 

$

532

 

 

$

237

 

$

769

 

$

488

 

 

$

192

 

$

680

Follistim AQ

 

29

 

 

 

30

 

 

59

 

 

24

 

 

33

 

 

57

 

 

110

 

 

 

127

 

 

237

 

 

84

 

 

 

108

 

 

193

NuvaRing

 

18

 

 

 

27

 

 

44

 

 

25

 

 

28

 

 

53

 

 

85

 

 

 

106

 

 

191

 

 

111

 

 

 

126

 

 

236

ganirelix acetate injection

 

3

 

 

 

22

 

 

26

 

 

4

 

 

21

 

 

25

 

 

22

 

 

 

88

 

 

111

 

 

11

 

 

 

69

 

 

81

Cerazette

 

 

 

 

18

 

 

18

 

 

 

 

16

 

 

16

 

 

 

 

 

70

 

 

70

 

 

 

 

 

67

 

 

67

Other Women’s Health(1)

 

14

 

 

 

29

 

 

42

 

 

45

 

 

30

 

 

74

 

 

96

 

 

 

139

 

 

234

 

 

165

 

 

 

133

 

 

298

Biosimilars

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Renflexis

 

46

 

 

 

5

 

 

51

 

 

35

 

 

4

 

 

39

 

 

164

 

 

 

21

 

 

186

 

 

123

 

 

 

12

 

 

135

Ontruzant

 

14

 

 

 

11

 

 

26

 

 

2

 

 

35

 

 

37

 

 

34

 

 

 

92

 

 

126

 

 

3

 

 

 

113

 

 

115

Brenzys

 

 

 

 

28

 

 

28

 

 

 

 

23

 

 

23

 

 

 

 

 

63

 

 

63

 

 

 

 

 

74

 

 

74

Other Biosimilars(1)

 

 

 

 

13

 

 

13

 

 

 

 

4

 

 

4

 

 

 

 

 

49

 

 

49

 

 

 

 

 

6

 

 

6

Established Brands

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cardiovascular

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zetia

 

4

 

 

 

92

 

 

96

 

 

3

 

 

94

 

 

98

 

 

10

 

 

 

368

 

 

378

 

 

(1

)

 

 

483

 

 

482

Vytorin

 

3

 

 

 

34

 

 

37

 

 

3

 

 

40

 

 

43

 

 

11

 

 

 

153

 

 

164

 

 

12

 

 

 

170

 

 

182

Atozet

 

 

 

 

110

 

 

110

 

 

 

 

105

 

 

105

 

 

 

 

 

458

 

 

458

 

 

 

 

 

453

 

 

453

Rosuzet

 

 

 

 

19

 

 

19

 

 

 

 

36

 

 

36

 

 

 

 

 

68

 

 

68

 

 

 

 

 

130

 

 

130

Cozaar/Hyzaar

 

3

 

 

 

90

 

 

93

 

 

4

 

 

90

 

 

94

 

 

12

 

 

 

345

 

 

357

 

 

21

 

 

 

365

 

 

386

Zocor

 

1

 

 

 

15

 

 

16

 

 

1

 

 

18

 

 

19

 

 

4

 

 

 

61

 

 

65

 

 

3

 

 

 

75

 

 

77

Other Cardiovascular(1)

 

 

 

 

27

 

 

27

 

 

 

 

39

 

 

39

 

 

 

 

 

126

 

 

126

 

 

 

 

 

162

 

 

162

Respiratory

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Singulair

 

5

 

 

 

108

 

 

113

 

 

4

 

 

120

 

 

124

 

 

15

 

 

 

398

 

 

413

 

 

18

 

 

 

444

 

 

462

Nasonex

 

2

 

 

 

61

 

 

62

 

 

3

 

 

55

 

 

57

 

 

4

 

 

 

201

 

 

206

 

 

12

 

 

 

206

 

 

218

Dulera

 

34

 

 

 

10

 

 

44

 

 

33

 

 

8

 

 

41

 

 

154

 

 

 

36

 

 

190

 

 

188

 

 

 

34

 

 

222

Clarinex

 

1

 

 

 

27

 

 

28

 

 

2

 

 

19

 

 

21

 

 

6

 

 

 

106

 

 

111

 

 

7

 

 

 

123

 

 

130

Asmanex

 

14

 

 

 

2

 

 

16

 

 

17

 

 

2

 

 

20

 

 

57

 

 

 

7

 

 

63

 

 

76

 

 

 

8

 

 

83

Other Respiratory(1)

 

(1

)

 

 

10

 

 

9

 

 

2

 

 

7

 

 

9

 

 

 

 

 

26

 

 

26

 

 

3

 

 

 

32

 

 

35

Non-Opioid Pain, Bone and Dermatology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Arcoxia

 

 

 

 

60

 

 

60

 

 

 

 

54

 

 

54

 

 

 

 

 

244

 

 

244

 

 

 

 

 

258

 

 

258

Fosamax

 

1

 

 

 

42

 

 

43

 

 

1

 

 

39

 

 

40

 

 

4

 

 

 

172

 

 

175

 

 

4

 

 

 

176

 

 

180

Diprospan

 

 

 

 

33

 

 

33

 

 

 

 

32

 

 

32

 

 

 

 

 

125

 

 

125

 

 

 

 

 

118

 

 

118

Diprosone

 

 

 

 

22

 

 

22

 

 

 

 

23

 

 

23

 

 

1

 

 

 

86

 

 

87

 

 

1

 

 

 

82

 

 

83

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

 

4

 

 

 

46

 

 

50

 

 

5

 

 

46

 

 

50

 

 

15

 

 

 

183

 

 

199

 

 

9

 

 

 

186

 

 

195

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proscar

 

 

 

 

25

 

 

26

 

 

 

 

22

 

 

22

 

 

1

 

 

 

116

 

 

117

 

 

2

 

 

 

174

 

 

176

Propecia

 

4

 

 

 

31

 

 

36

 

 

2

 

 

36

 

 

39

 

 

9

 

 

 

127

 

 

136

 

 

10

 

 

 

119

 

 

129

Sinemet

 

 

 

 

17

 

 

17

 

 

 

 

20

 

 

20

 

 

 

 

 

71

 

 

71

 

 

(1

)

 

 

78

 

 

77

Remeron

 

1

 

 

 

14

 

 

15

 

 

1

 

 

16

 

 

16

 

 

3

 

 

 

62

 

 

66

 

 

2

 

 

 

61

 

 

64

Other(1)

 

7

 

 

 

58

 

 

65

 

 

9

 

 

50

 

 

60

 

 

37

 

 

 

185

 

 

223

 

 

53

 

 

 

185

 

 

238

Other (2)

 

(3

)

 

 

38

 

 

34

 

 

1

 

 

57

 

 

58

 

 

(3

)

 

 

205

 

 

200

 

 

4

 

 

 

102

 

 

107

Total Revenue

$

347

 

 

$

1,257

 

$

1,604

 

$

340

 

$

1,272

 

$

1,613

 

$

1,383

 

 

$

4,921

 

$

6,304

 

$

1,408

 

 

$

5,124

 

$

6,532

U.S. plus international may not equal total due to rounding.
(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 and other third parties, and allocated amounts from pre-spin revenue hedging activities through the date of Separation.

TABLE 3

Organon & Co.

Sales by geographic area

(Unaudited, $ in millions)

 

 

Three Months Ended December 31,

 

Twelve Months Ended December 31,

($ in millions)

2021

 

2020

 

2021

 

2020

Europe and Canada

$

427

 

$

440

 

$

1,741

 

$

1,726

United States

 

347

 

 

340

 

 

1,383

 

 

1,408

Asia Pacific and Japan

 

299

 

 

345

 

 

1,173

 

 

1,535

China

 

240

 

 

218

 

 

933

 

 

873

Latin America, Middle East, Russia and Africa

 

246

 

 

208

 

 

841

 

 

857

Other(1)

 

45

 

 

62

 

 

233

 

 

133

Revenue

$

1,604

 

$

1,613

 

$

6,304

 

$

6,532

(1)
Other includes manufacturing sales to Merck and other third parties, and allocated amounts from pre-spin revenue hedging activities through the date of Separation.

TABLE 4

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

($ in millions)

 

 

Three Months Ended December 31,

 

Twelve Months Ended December 31,

 

 

2021

 

 

 

2020

 

 

 

2021

 

 

 

2020

 

Revenue

$

1,604

 

 

$

1,613

 

 

$

6,304

 

 

$

6,532

 

Cost of sales

 

599

 

 

 

586

 

 

 

2,382

 

 

 

2,119

 

Gross profit

 

1,005

 

 

 

1,027

 

 

 

3,922

 

 

 

4,413

 

Gross margin

 

62.7

%

 

 

63.7

%

 

 

62.2

%

 

 

67.6

%

Amortization

 

34

 

 

 

21

 

 

 

103

 

 

 

86

 

One-time costs(1)

 

17

 

 

 

 

 

 

45

 

 

 

 

Stock-based compensation

 

3

 

 

 

3

 

 

 

11

 

 

 

17

 

Non-GAAP adjusted gross profit
(2)

 

1,059

 

 

 

1,051

 

 

 

4,081

 

 

 

4,516

 

Non-GAAP adjusted gross margin

 


66.0


%

 

 


65.2


%

 

 


64.7


%

 

 


69.1


%

(1)
One-time costs for the three months ended December 31, 2021 include costs to stand up the Company as well as a $7 million impairment charge relating to a licensed intangible asset. For the twelve month period ended December 31, 2021, one time costs include inventory discards related to separation re-labeling and other costs to stand up the Company.
 
(2)
Non-GAAP adjusted gross profit is calculated by excluding amortization, one-time costs described above, and the portion of stock-based compensation expense allocated to Cost of sales.

TABLE 5

Organon & Co.

Reconciliation of GAAP Net Income from Continuing Operations to Adjusted EBITDA

($ in millions)

 

 

Three Months Ended December 31,

 

Twelve Months Ended December 31,

 

 

2021

 

 

 

2020

 

 

 

2021

 

 

 

2020

 

Net income from continuing operations before income tax

$

236

 

 

$

525

 

 

$

1,529

 

 

$

2,752

 

Depreciation

 

28

 

 

 

14

 

 

 

92

 

 

 

56

 

Amortization(1)

 

34

 

 

 

21

 

 

 

103

 

 

 

86

 

Interest expense

 

98

 

 

 

 

 

 

258

 

 

 

 

EBITDA

 

396

 

 

 

560

 

 

 

1,982

 

 

 

2,894

 

Restructuring costs

 

 

 

 

17

 

 

 

3

 

 

 

60

 

One-time costs(2)

 

59

 

 

 

95

 

 

 

231

 

 

 

126

 

Acquired in-process research and development(3)

 

79

 

 

 

 

 

 

104

 

 

 

 

Stock-based compensation

 

15

 

 

 

8

 

 

 

59

 

 

 

40

 

Adjusted EBITDA

$

549

 

 

$

680

 

 

$

2,379

 

 

$

3,120

 


Adjusted EBITDA margin

 


34.2


%

 

 


42.2


%

 

 


37.7


%

 

 


47.8


%

(1)
Amortization in all periods is included in Cost of sales.
 
(2)
For the three months ended December 31, 2021, one-time costs primarily include costs incurred in connection with the spin-off of Organon as well as $5 million of transaction costs pertaining to the Forendo acquisition and a $7 million impairment charge of a licensed intangible asset. For the three months ended December 31, 2021, approximately $26 million of the one-time costs are recorded in Selling, general and administrative expenses, approximately $17 million are recorded in Cost of sales, approximately $9 million are recorded in Research and development, and $7 million in Other (income) expense, net. For the three months ended December 31, 2020, $95 million of the one-time costs are classified in Selling, general and administrative expenses.
 
For the twelve months ended December 31, 2021, approximately $165 million of the one-time costs are recorded in Selling, general and administrative expenses (which includes $23 million pertaining to the acquisition of Alydia in the second quarter 2021), approximately $45 million are recorded in Cost of sales, $14 million are recorded in Research and development, and $7 million are recorded in Other (income) expense, net. For the twelve months ended December 31, 2020, $126 million of one-time costs are classified in Selling, general and administrative expenses.
 
(3)
Costs represent $79 million related to the Forendo acquisition in the fourth quarter 2021 and the twelve month period for 2021 includes the $25 million upfront licensing payment associated with ObsEva in the third quarter 2021, both of which were recorded in Research and development expense.

TABLE 6

Organon & Co.

Reconciliation of GAAP Net Income to Non-GAAP Adjusted Net Income

($ in millions, except per share amounts)

 

 

Three Months Ended December 31,

 

Twelve Months Ended December 31,

 

2021

 

2020

 

2021

 

2020

Net income from continuing operations before income tax

$

236

 

$

525

 

$

1,529

 

$

2,752

Adjustments:

 

 

 

 

 

 

 

Amortization(1)

 

34

 

 

21

 

 

103

 

 

86

Restructuring costs

 

 

 

17

 

 

3

 

 

60

One-time costs(2)

 

59

 

 

95

 

 

231

 

 

126

Acquired in-process research and development(3)

 

79

 

 

 

 

104

 

 

Stock-based compensation

 

15

 

 

8

 

 

59

 

 

40

Total Adjustments

 

187

 

 

141

 

 

500

 

 

312

Non-GAAP pre-tax income from continuing operations

 

423

 

 

666

 

 

2,029

 

 

3,064

Taxes on income as reported in accordance with GAAP

 

34

 

 

149

 

 

178

 

 

496

Tax benefit on adjustments

 

35

 

 

23

 

 

93

 

 

45

Tax benefit on GAAP-only discrete items(4)

 

5

 

 

 

 

96

 

 

Non-GAAP adjusted taxes on income

 

74

 

 

172

 

 

367

 

 

541

Non-GAAP adjusted net income, continuing operations

$

349

 

$

494

 

$

1,662

 

$

2,523

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

$

1.37

 

$

1.95

 

$

6.54

 

$

9.95

(1)
Amortization in all periods is included in Cost of sales.
 
(2)
For the three months ended December 31, 2021, one-time costs primarily include costs incurred in connection with the spin-off of Organon as well as $5 million of transaction costs pertaining to the Forendo acquisition and a $7 million impairment charge of a licensed intangible asset. For the three months ended December 31, 2021, approximately $26 million of the one-time costs are recorded in Selling, general and administrative expenses, approximately $17 million are recorded in Cost of sales, approximately $9 million are recorded in Research and development, and $7 million in Other (income) expense, net. For the three months ended December 31, 2020, $95 million of the one-time costs are classified in Selling, general and administrative expenses.
 
For the twelve months ended December 31, 2021, approximately $165 million of the one-time costs are recorded in Selling, general and administrative expenses (which includes $23 million pertaining to the acquisition of Alydia in the second quarter 2021), approximately $45 million are recorded in Cost of sales, $14 million are recorded in Research and development, and $7million are recorded in Other (income) expense, net. For the twelve months ended December 31, 2020, $126 million of one-time costs are classified in Selling, general and administrative expenses.
 
(3)
Costs represent $79 million related to the Forendo acquisition in the fourth quarter 2021 and the twelve month period for 2021 includes the $25 million upfront licensing payment associated with ObsEva in the third quarter 2021, both of which were recorded in Research and development expense.
 
(4)
For the three months and twelve months ended December 31, 2021, the company recorded a tax benefit of approximately $5 million and $75 million, respectively, related to a portion of non-US step up in tax basis as a result of its separation from Merck.

 


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.

Acquisition Immediately Adds to Organon’s Suite of Contraceptive Offerings and Continues to Build on Strong Foundation in Women’s Health Around the World


Organon (NYSE: OGN) today announced that it has acquired the rights from Bayer AG to Marvelon® and Mercilon®, combined oral hormonal daily contraceptive pills, in the People’s Republic of China, including Hong Kong and Macau, and has entered into an agreement to acquire the rights to these products in Vietnam. Marvelon and Mercilon are already owned, manufactured, and marketed by Organon as prescription oral contraceptives in 20 other markets. This acquisition gives Organon full global ownership of these brands (except in South Korea) by reacquiring the rights to them in these markets. The agreement to acquire the rights in Vietnam is expected to close in the first half of 2022 and is subject to customary closing conditions, including regulatory approval.

“This is an important opportunity for Organon as we look to grow our contraception portfolio and further bolster our offerings to women in all parts of the world through strategic business development,” said Susanne Fiedler, Chief Commercial Officer at Organon. “With Marvelon and Mercilon in the People’s Republic of China, including Hong Kong and Macau, and potentially Vietnam, we will have an opportunity to reach more women who are looking for contraceptive options in these markets and help to empower them with choice in an area of health that is important to them.”

Marvelon is currently available over the counter in the People’s Republic of China and both Marvelon and Mercilon are available over the counter in Hong Kong and Macau. Marvelon and Mercilon are currently available by prescription in Vietnam. Both contraceptives were acquired by Bayer AG in these markets from Merck & Co., Inc. in 2014 as part of the sale of Merck & Co.’s consumer care business. Marvelon and Mercilon are not available in the United States.

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.

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 management’s expectations about Organon’s acquisition of Marvelon and Mercilon, (including the expected timing and benefits thereof), Organon’s ability to grow its contraception portfolio, and its ability to bolster its offerings and reach more women. Forward-looking statements may be identified by words such as “hope,” or “hopes,” “expects,” “potential,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will” or words of similar meaning. Such 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, an inability to execute on our business development strategy, an inability to obtain regulatory approval for such acquisition in Vietnam, a failure to realize the benefits of our acquisition of Marvelon and Mercilon or any other 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; 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 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 its registration statement on Form 10 and subsequent quarterly reports on Form 10-Q,available at the SEC’s Internet site (www.sec.gov).


Media Contacts:

Karissa Peer

(614) 314-8094

Kim Hamilton

(908) 391-0131

Investor Contacts:

Jennifer Halchak

(201) 275-2711

Edward Barger

(267) 614-4669

Source: Organon & Co.


As the COVID-19 pandemic continues to have a disproportionate impact on women, Organon issues a call to action for other leaders to create opportunities to focus on women’s health


Organon (NYSE: OGN), a global women’s health company, is designating International Women’s Day (IWD) on March 8 as a day to recognize the growing health disparities women face that have been exacerbated by the COVID-19 pandemic. Since its inception, IWD has focused on accelerating gender parity. Organon recognizes the need for a global effort to address her health and is starting with its own employees by providing paid time off this year for all employees to attend to their own health needs. The company invites organizations across the globe to join in raising awareness of the inequity in women’s health and to adopt initiatives that help women prioritize their health.

Women have worked hard to advance in the workplace, but the pandemic is unraveling these hard-fought gains. Women are now significantly more burned out than ever, even more than men1—which can take a huge toll on their physical and mental health. Even before the pandemic, in a 2015 survey, 78% of women said they usually put their own healthcare needs, such as scheduling doctor’s appointments, aside to focus on taking care of their family and other priorities.2

“Organon launched with a commitment to listen to the needs of women and as part of our research, we learned that women are finding it harder than ever to make the time to care for even their most basic health needs,” said Kevin Ali, chief executive officer, Organon. “As a company investing in innovation to improve women’s health, I felt a responsibility to help address this within our own global community of almost 9,500 employees. This year, the symbolic action we are taking is to encourage all our people to spend this day off to make a commitment to their own health or the health of the women in their lives, whether that’s going to the doctor, taking stock of their own wellbeing or reflecting on how to make a change.”

We believe healthy women are the backbone of a thriving, stable and resilient society and when she is healthy, she prospers and so does her community and her society, for generations to come. Yet, a recent study found that 44% of older women said they waited until a health symptom became urgent before scheduling an appointment – and that number jumps to 62% for women aged 20-34.3This is what Organon is hoping to change and asks others to join in the effort to improve women’s health.

“Empowering women to put themselves at the top of the list has always been a priority for HealthyWomen and is an important part of our mission to educate women on the importance of making informed decisions about their health,” said Beth Battaglino, chief executive officer, HealthyWomen. “As the pandemic continues to limit women’s ability for self-care, we are proud of Organon for joining the movement and call on other companies to recognize International Women’s Day as a day to honor women’s unmet health needs.”

We believe that by improving the understanding of women’s health needs, we are one step closer to closing the inequity gap. Organon urges all organizations to join in this mission and be part of the solution. Visit hereforherhealth.com/make-time to learn more.

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.

_____________________________

1 McKinsey & Company: Women in the Workplace 2021: https://www.mckinsey.com/featured-insights/diversity-and-inclusion/women-in-the-workplace

2 HealthyWomen: https://www.healthywomen.org/content/article/new-survey-moms-are-putting-their-health-last

3 WJMC: https://www.wjmc.org/blogs/2021/october/women-putting-your-health-first-is-not-selfish-i/


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 fourth quarter and full year 2021 financial results on February 17, 2022, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EST.

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# 2682555 and by clicking on this link: http://www.directeventreg.com/registration/event/2682555. 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, (NYSE: MRK), known as MSD outside of the United States and Canada, to focus on improving the health of women throughout their lives. Here for her health, the company has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the reproductive 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 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 9,000 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 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.


Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for a citrate-free, high-concentration (100 mg/mL) formulation of SB5 (adalimumab-bwwd), a biosimilar candidate referencing HUMIRA® (adalimumab).1 SB5 was previously approved by the FDA under the brand name HADLIMA™ as a low-concentration (50 mg/mL) formulation in July 2019. The low concentration and high concentration forms of the reference product are both marketed in the United States (U.S.) today.

The sBLA for citrate-free, high-concentration adalimumab was submitted by Samsung Bioepis in October 2021 and was based on clinical data from a randomized, single-blind, two-arm, parallel group, single-dose study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of SB5 (100 mg/mL vs 50 mg/mL) in healthy volunteers.

SB5 will be commercialized in the U.S. by Organon. It is expected to launch in the U.S. on or after July 1, 2023, in accordance with a licensing agreement with AbbVie Inc.


About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, endocrinology, and gastroenterology. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.


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. Here for her health, Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the reproductive 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 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 9,000 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

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 Organon management’s expectations about Organon’s commercialization of SB5 and its licensing agreement with AbbVie Inc. 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; 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 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 its registration statement on Form 10, available at the SEC’s Internet site (www.sec.gov).


Endnotes

1. HUMIRA® is a registered trademark of AbbVie Inc.



Media Contact – Samsung Bioepis



Anna Nayun Kim, nayun86.kim@samsung.com

Yoon Kim, yoon1.kim@samsung.com

Media Contacts – Organon

Karissa Peer, karissa.peer@organon.com

Hannah Silver, hannah.silver@organon.com

Kim Burke Hamilton, kim.hamilton@organon.com


Investor Contacts

Jennifer Halchak

(201) 275-2711

Edward Barger

(267) 614-4669

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 40th Annual J.P. Morgan Healthcare Virtual Conference on Monday, January 10, 2022 at 2:15 p.m. ET.

Investors, analysts, members of the media and the general public are invited to listen to a live audio 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. Here for her health, Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the reproductive 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 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 that serves people in over 140 markets, world-class commercial capabilities and approximately 9,000 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 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.

Expands women’s health pipeline with novel candidates targeting endometriosis and polycystic ovarian syndrome (PCOS)


Organon (NYSE: OGN), a global women’s healthcare company, today announced the completion of its acquisition of Forendo Pharma, a clinical-stage drug development company focused on novel treatments in women’s health. Forendo’s lead candidate, FOR-6219, is an investigational, potentially first-in-class oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor entering Phase 2 clinical development for endometriosis. Forendo’s pipeline also includes a preclinical program targeting polycystic ovarian syndrome (PCOS).

FOR-6219 has potential to act locally in the target tissues without impacting systemic hormone levels. This potential selective activity allows for its evaluation as a long-term treatment option for endometriosis – a current therapeutic gap.

“Despite the high prevalence of endometriosis, current treatment options are not adequately addressing the painful and challenging symptoms of women living with this disorder,” said Dr. Sandra Milligan, Head of Research & Development at Organon. “Through our acquisition of Forendo, we hope to bring innovation to this therapeutic area and enable future treatment options – in line with our continued focus on building a robust pipeline that addresses a broad spectrum of conditions impacting women.”

Consideration for the transaction includes a $75 million upfront payment, assumption of approximately $9 million of Forendo debt, payments upon the achievement of certain development and regulatory milestones of up to $270 million and commercial milestones payments of up to $600 million, which together could amount to total consideration of $954 million. Moelis & Company acted as exclusive financial advisor to Forendo.

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. Here for her health, Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the reproductive 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 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 that serves people in over 140 markets, world-class commercial capabilities and approximately 9,000 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

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 management’s expectations about Organon’s acquisition of Forendo and the potential of FOR-6219 to become a long-term treatment option for endometriosis. Forward-looking statements may be identified by words such as “hope,” or “hopes,” “expects,” “potential,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will” or words of similar meaning. These statements include statements about the acquisition of Forendo and the potential for innovation and future treatment options. Such 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, an inability to execute on our business development strategy or realize the benefits of our acquisition of Forendo or any other 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; 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 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 its registration statement on Form 10, available at the SEC’s Internet site (www.sec.gov).

About Forendo

Forendo is pioneering the translation of intracrinology science into first-in-class therapeutic solutions. Intracrinology enables physicians to address diseases on an unprecedented tissue-specific level. Forendo’s lead clinical compound in endometriosis is being evaluated for its potential effect on endometriotic lesions, a significant unmet need. The company’s second program is targeting polycystic ovarian syndrome (PCOS) which currently has no approved therapies. In addition to women’s health programs, Forendo has a strategic collaboration with Novartis leveraging its unique HSD17B platform in chronic liver diseases. Forendo is based in Finland and backed by Novo Seeds, Karolinska Development, Innovestor, Novartis Venture Fund, M Ventures, Vesalius Biocapital III Partners and Sunstone Life Science Ventures. For more information, please visit: www.forendo.com.


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.


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 Evercore ISI 4th Annual HealthCONx Conference on Wednesday, December 1, 2021 at 1:50 p.m. ET.

Investors, analysts, members of the media and the general public are invited to watch 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. Here for her health, Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the reproductive 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 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 that serves people in over 140 markets, world-class commercial capabilities and approximately 9,000 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 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.

  • Third quarter 2021 revenue of $1,600 million
  • Net income from continuing operations of $323 million, or $1.27 per diluted share; Adjusted net income from continuing operations of $424 million, or $1.67 per diluted share
  • Adjusted EBITDA of $636 million
  • Board of Directors declares quarterly dividend of $0.28 per share
  • Financial guidance affirmed;  ranges for revenue and Adjusted EBITDA margin, narrowed
  • Executing on business development; announces acquisition of Forendo Pharma


Organon (NYSE: OGN) (the “company”), today announced its results for the third quarter and year to date ended September 30, 2021.

Organon also announced that its Board of Directors declared a quarterly dividend of $0.28 for each issued and outstanding share of the company’s common stock. The dividend is payable on December 16, 2021 to stockholders of record at the close of business on November 22, 2021.

“Just months after becoming a standalone company, we are delivering on what we set out to do. Our year to date results are very much in line with expectations, and with good visibility into the remainder of the year, we are affirming our financial guidance,” said Kevin Ali, Organon’s CEO. “Importantly, we have also been disciplined in actioning business development opportunities that have been in the works well prior to spin. Including today’s announcement regarding the proposed acquisition of Forendo Pharma, we have executed three transactions in the last six months, demonstrating our commitment to advance innovation in large, underserved markets, which women’s health has lacked for decades.”


Third quarter 2021 revenue

in $ millions

 

Q3 2021

 

Q3 2020

 

VPY

 

VPY ex-FX

Women’s Health

 

381

 

424

 

(10)%

 

(11)%

Biosimilars

 

140

 

99

 

41%

 

39%

Established Brands

 

1,027

 

1,088

 

(6)%

 

(8)%

Other(1)

 

52

 

2

 

NM

 

NM

Revenue

 

1,600

 

1,613

 

(1)%

 

(3)%


(1) Other represents manufacturing sales to the company’s former parent company and other third parties and pre-spin allocated revenue hedge activities

Total net revenue was $1,600 million for the third quarter of 2021, a decrease of 1% as-reported and 3% excluding the impacts of foreign currency (ex-FX), compared with the third quarter of 2020.

Women’s Health declined 10% as-reported and 11% ex-FX in the third quarter 2021 compared with the third quarter of 2020, driven primarily by a 17% ex-FX decline in NUVARING® (etonogestrel/ethinyl estradiol vaginal ring) which continues to be impacted by generic competition, and also NEXPLANON® (etonogestrel implant), which declined 8% ex-FX in the third quarter 2021. In September 2020, there was short-lived resurgence in patient well visits that positively impacted third quarter 2020 NEXPLANON sales, which is a physician-administered product. Throughout the current year, well visits in the US continue to be suppressed by the COVID-19 pandemic, hampering NEXPLANON sales. The decline in the company’s contraception portfolio was partially offset by the fertility franchise, led by FOLLISTIM®, AQ Cartridge (follitropin beta injection) which grew 18% ex-FX, and was positively impacted by a combination of COVID-19 recovery and increased demand.

Biosimilars revenue grew 41% as-reported and 39% ex-FX in the third quarter 2021 compared with third quarter 2020, driven by continued demand growth in the US for RENFLEXIS® (infliximab-abda), since its launch in 2017 as well as growth in Canada. The biosimilars portfolio also benefited from the continued uptake of ONTRUZANT® (trastuzumab-dttb) in the US since the July 2020 launch in the US, as well as strong performance in Brazil, partially offset by a decrease in the EU reflecting increasing competitive pressures and tenders lost.

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. Revenue for Established Brands was down 6% as-reported and down 8% ex-FX in the third quarter of 2021. Excluding the impact of loss of exclusivity (LOE), Established Brands revenue was down 4% ex-FX. During the quarter, retail expansion in China grew 20% and partially offset impacts from decreases in the hospital channel due to Volume Based Procurement (VBP). The portfolio impacts from LOE as well as VBP were partially offset by a 3% ex-FX increase in respiratory medicines. SINGULAIR® (montelukast) was up 20% ex-FX due to higher volume and recovery from the COVID-19 pandemic in China, despite its exposure to VBP, and NASONEX® (mometasone) was up 13% ex-FX due to higher demand in China and favorable performance in Russia, partially offset by generic competition in Japan.


Third quarter 2021 profitability

in $ millions, except per share amounts

 

Q3 2021

 

Q3 2020

 

VPY

Revenue

 

$

1,600

 

 

$

1,613

 

 

(1)%

Cost of goods sold

 

609

 

 

535

 

 

14%

Gross profit

 

991

 

 

1,078

 

 

(8)%

Gross margin

 

61.9

%

 

66.8

%

 

 

Non-GAAP Adjusted gross profit(1)

 

1,038

 

 

1,106

 

 

(6)%

Non-GAAP Adjusted gross margin

 

64.9

%

 

68.6

%

 

 

Adjusted EBITDA, continuing operations(1,2)

 

636

 

 

751

 

 

(15)%

Adjusted EBITDA margin, continuing operations

 

39.8

%

 

46.6

%

 

 

Net Income, continuing operations(2)

 

323

 

 

560

 

 

(42)%

Non-GAAP Adjusted net income, continuing operations(1,2)

 

424

 

 

604

 

 

(30)%

Diluted Earnings per Share, continuing operations(2)

 

1.27

 

 

2.21

 

 

(43)%

Non-GAAP Adjusted Diluted Earnings per Share, continuing operations(1,2)

 

1.67

 

 

2.38

 

 

(30)%


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



(2) Discontinued operations includes Merck Retained Products

Gross margin was 61.9% as-reported and 64.9% on an adjusted basis in the third quarter of 2021 compared with 66.8% as-reported and 68.6% on an adjusted basis in the third quarter of 2020. The year-over-year decrease reflects costs of standing up Organon as an independent company, including certain costs related to manufacturing agreements between the company and its former parent company, which have lower gross margin percentages compared to third party product sales and purchases. Those manufacturing agreements had an approximate 180 basis point negative impact to gross margins.

Adjusted EBITDA margin was 39.8% in the third quarter of 2021 compared with 46.6% in the third quarter of 2020, which reflects costs incurred to establish Organon as a stand alone entity.

Net income from continuing operations for the third quarter of 2021 was $323 million, or $1.27 per diluted share, compared with $560 million, or $2.21 per diluted share, in the third quarter of 2020. Non-GAAP Adjusted net income from continuing operations was $424 million, or $1.67 per diluted share, compared with $604 million, or $2.38 per diluted share, in 2020.


Capital Allocation

Today, Organon’s Board of Directors declared a quarterly dividend of $0.28 for each issued and outstanding share of the company’s common stock. The dividend is payable on December 16, 2021 to stockholders of record at the close of business on November 22, 2021.

As of September 30, 2021, cash and cash equivalents were $1,008 million, and debt was $9,298 million, resulting in net debt of $8,290 million.


Full year guidance – all guidance provided on a Non-GAAP basis

Organon does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty and without unreasonable effort, the ultimate outcome of legal proceedings, unusual gains and losses, 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 affirmed all financial guidance, and narrowed the ranges for revenue and Adjusted EBITDA margin. The financial guidance is presented on a non-GAAP basis and is proforma as if Organon was a standalone company for the entire year.

Guidance on proforma non-GAAP basis

 

Previous guidance

 

Current guidance

Revenue

 

$6.1B – $6.4B

 

$6.2B – 6.3B

Gross margin(*)

 

Low to mid-60% range

 

Unchanged

SG&A as % of sales(*)

 

Mid 20% range

 

Unchanged

R&D as % of sales(*)

 

Mid single-digit

 

Unchanged

Adjusted EBITDA margin

 

36%-38%

 

36.5%-37.5%

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

 

~254 million

 

Unchanged


(*) Guidance provided in connection with the spin-off and unlikely to be a recurring component of the company’s annual guidance


Webcast Information

Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its third quarter 2021 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 by clicking on this link: http://www.directeventreg.com/registration/event/2594964. 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 in June 2021 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. “Here for her health”, the company has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the reproductive 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 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 and world-class commercial capabilities. The company’s approximately 9,000 employees conduct business in more than 140 countries and territories. Organon’s headquarters are located in Jersey City, New Jersey.

Non-GAAP financial measures

Non-GAAP results, such as Adjusted EBITDA, Adjusted Net Income, and Adjusted Diluted EPS, are presented only as a supplement to the company’s financial statements based on GAAP. Non-GAAP financial information is provided to enhance understanding of the company’s financial performance, but none of these non-GAAP financial measures are recognized terms under GAAP, and non-GAAP measures should not be considered in isolation from, or as a substitute analysis for, the company’s results of operations as determined in accordance with GAAP. Definitions and reconciliations of non-GAAP measures to the most directly comparable GAAP measures are provided within the schedules attached to this release. The company uses non-GAAP 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. The company also believes that investors may find non-GAAP financial measures useful for the same reasons, although investors are cautioned that non-GAAP financial measures are not a substitute for GAAP disclosures. The non-GAAP financial measures are not presented in accordance with GAAP. Please refer to the appendix of this press release for reconciliations of non-GAAP financial measures contained herein to the most directly comparable GAAP measures. The company’s full-year 2021 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.

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 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; the company’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.

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 its registration statement on Form 10, 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 September 30,

 

Nine Months Ended September 30,

 

2021

 

2020

 

2021

 

2020

Sales

$

1,600

 

 

$

1,613

 

 

$

4,701

 

 

$

4,919

 

Costs, Expenses and Other

 

 

 

 

 

 

 

Cost of sales

609

 

 

535

 

 

1,783

 

 

1,533

 

Selling, general and administrative

388

 

 

321

 

 

1,186

 

 

922

 

Research and development

111

 

 

54

 

 

254

 

 

150

 

Restructuring costs

1

 

 

12

 

 

3

 

 

43

 

Other (income) expense, net

102

 

 

10

 

 

182

 

 

44

 

 

1,211

 

 

932

 

 

3,408

 

 

2,692

 

Income From Continuing Operations Before Income Taxes

389

 

 

681

 

 

1,293

 

 

2,227

 

Taxes on Income

66

 

 

121

 

 

144

 

 

347

 

Net Income From Continuing Operations

323

 

 

560

 

 

1,149

 

 

1,880

 

Loss From Discontinued Operations – Net of Tax

 

 

(13)

 

 

 

 

(88)

 

Net Income

$

323

 

 

$

547

 

 

$

1,149

 

 

$

1,792

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

Continuing operations

$

1.27

 

 

$

2.21

 

 

$

4.53

 

 

$

7.42

 

Discontinued operations

 

 

(0.05)

 

 

 

 

(0.35)

 

Net Earnings per Share Attributable to Organon & Co. Stockholders

$

1.27

 

 

$

2.16

 

 

$

4.53

 

 

$

7.07

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

Continuing operations

$

1.27

 

 

$

2.21

 

 

$

4.52

 

 

$

7.42

 

Discontinued operations

 

 

(0.05)

 

 

 

 

(0.35)

 

Net Earnings per Share Attributable to Organon & Co. Stockholders

$

1.27

 

 

$

2.16

 

 

$

4.52

 

 

$

7.07

 

 

 

 

 

 

 

 

 

Weighted Average Shares Outstanding:

 

 

 

 

 

 

 

Basic

253,534,000

 

 

253,516,000

 

 

253,530,000

 

 

253,516,000

 

Diluted

254,172,000

 

 

253,516,000

 

 

254,011,000

 

 

253,516,000

 

TABLE 2

Organon & Co.


Sales by top products

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

2021

 

2020

 

2021

 

2020

($ 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

$

120

 

 

$

55

 

 

$

175

 

 

$

137

 

 

$

52

 

 

$

189

 

 

$

389

 

 

$

154

 

 

$

543

 

 

$

374

 

 

$

142

 

 

$

515

 

Follistim AQ

29

 

 

32

 

 

61

 

 

20

 

 

31

 

 

50

 

 

81

 

 

97

 

 

178

 

 

60

 

 

75

 

 

135

 

NuvaRing

21

 

 

28

 

 

49

 

 

25

 

 

33

 

 

58

 

 

68

 

 

79

 

 

147

 

 

86

 

 

98

 

 

184

 

Ganirelix Acetate Injection

5

 

 

20

 

 

25

 

 

4

 

 

21

 

 

25

 

 

19

 

 

66

 

 

85

 

 

7

 

 

48

 

 

55

 

Cerazette

 

 

18

 

 

18

 

 

 

 

18

 

 

18

 

 

 

 

53

 

 

53

 

 

 

 

51

 

 

51

 

Other Women’s Health(1)

18

 

 

35

 

 

53

 

 

45

 

 

39

 

 

84

 

 

80

 

 

111

 

 

191

 

 

121

 

 

103

 

 

224

 

Biosimilars

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Renflexis

48

 

 

6

 

 

54

 

 

34

 

 

4

 

 

38

 

 

119

 

 

17

 

 

136

 

 

88

 

 

8

 

 

96

 

Ontruzant

9

 

 

47

 

 

56

 

 

 

 

37

 

 

37

 

 

20

 

 

81

 

 

101

 

 

1

 

 

77

 

 

78

 

Brenzys

 

 

14

 

 

14

 

 

 

 

23

 

 

23

 

 

 

 

35

 

 

35

 

 

 

 

52

 

 

52

 

Other Biosimilars(1)

 

 

16

 

 

16

 

 

 

 

1

 

 

1

 

 

 

 

34

 

 

34

 

 

 

 

1

 

 

1

 

Established Brands

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cardiovascular

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zetia

1

 

 

90

 

 

91

 

 

(1)

 

 

103

 

 

103

 

 

6

 

 

276

 

 

282

 

 

(4)

 

 

389

 

 

384

 

Vytorin

3

 

 

38

 

 

41

 

 

3

 

 

44

 

 

47

 

 

8

 

 

119

 

 

127

 

 

9

 

 

130

 

 

139

 

Atozet

 

 

114

 

 

114

 

 

 

 

111

 

 

111

 

 

 

 

347

 

 

347

 

 

 

 

348

 

 

348

 

Rosuzet

 

 

15

 

 

15

 

 

 

 

32

 

 

32

 

 

 

 

48

 

 

48

 

 

 

 

94

 

 

94

 

Cozaar/Hyzaar

3

 

 

84

 

 

87

 

 

5

 

 

86

 

 

91

 

 

9

 

 

256

 

 

265

 

 

17

 

 

274

 

 

291

 

Zocor

1

 

 

17

 

 

18

 

 

1

 

 

17

 

 

18

 

 

3

 

 

46

 

 

49

 

 

1

 

 

56

 

 

57

 

Other Cardiovascular(1)

 

 

31

 

 

31

 

 

 

 

37

 

 

37

 

 

 

 

99

 

 

99

 

 

 

 

124

 

 

124

 

Respiratory

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Singulair

2

 

 

98

 

 

100

 

 

4

 

 

78

 

 

82

 

 

10

 

 

289

 

 

300

 

 

14

 

 

324

 

 

338

 

Nasonex

 

 

49

 

 

48

 

 

 

 

41

 

 

41

 

 

3

 

 

141

 

 

144

 

 

9

 

 

151

 

 

160

 

Dulera

48

 

 

8

 

 

56

 

 

51

 

 

8

 

 

59

 

 

121

 

 

25

 

 

146

 

 

155

 

 

26

 

 

181

 

Clarinex

2

 

 

27

 

 

28

 

 

2

 

 

23

 

 

25

 

 

5

 

 

78

 

 

83

 

 

5

 

 

104

 

 

109

 

Asmanex

14

 

 

2

 

 

15

 

 

20

 

 

1

 

 

21

 

 

43

 

 

5

 

 

48

 

 

58

 

 

5

 

 

64

 

Other Respiratory(1)

 

 

3

 

 

3

 

 

 

 

11

 

 

11

 

 

 

 

15

 

 

16

 

 

1

 

 

25

 

 

26

 

Non-Opioid Pain, Bone and Dermatology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Arcoxia

 

 

65

 

 

65

 

 

 

 

68

 

 

68

 

 

 

 

184

 

 

184

 

 

 

 

204

 

 

204

 

Fosamax

1

 

 

45

 

 

46

 

 

1

 

 

45

 

 

46

 

 

3

 

 

130

 

 

132

 

 

3

 

 

137

 

 

140

 

Diprospan

 

 

34

 

 

34

 

 

 

 

33

 

 

33

 

 

 

 

92

 

 

92

 

 

 

 

87

 

 

87

 

Diprosone

 

 

22

 

 

22

 

 

 

 

22

 

 

22

 

 

1

 

 

64

 

 

65

 

 

1

 

 

58

 

 

59

 

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

9

 

 

47

 

 

57

 

 

3

 

 

49

 

 

52

 

 

11

 

 

137

 

 

148

 

 

5

 

 

140

 

 

144

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proscar

 

 

27

 

 

27

 

 

 

 

59

 

 

60

 

 

1

 

 

91

 

 

92

 

 

1

 

 

152

 

 

154

 

Propecia

1

 

 

33

 

 

34

 

 

2

 

 

30

 

 

32

 

 

5

 

 

96

 

 

101

 

 

7

 

 

83

 

 

91

 

Sinemet

 

 

17

 

 

17

 

 

 

 

18

 

 

18

 

 

 

 

54

 

 

54

 

 

(1)

 

 

58

 

 

58

 

Remeron

1

 

 

17

 

 

19

 

 

1

 

 

16

 

 

16

 

 

3

 

 

48

 

 

51

 

 

2

 

 

46

 

 

47

 

Other(1)

9

 

 

49

 

 

59

 

 

15

 

 

48

 

 

63

 

 

29

 

 

128

 

 

157

 

 

44

 

 

135

 

 

179

 

Other (2)

1

 

 

51

 

 

52

 

 

(1)

 

 

3

 

 

2

 

 

(2)

 

 

171

 

 

168

 

 

4

 

 

46

 

 

50

 

Total sales

$

346

 

 

$

1,254

 

 

$

1,600

 

 

$

371

 

 

$

1,242

 

 

$

1,613

 

 

$

1,035

 

 

$

3,666

 

 

$

4,701

 

 

$

1,068

 

 

$

3,851

 

 

$

4,919

 

U.S. plus international may not equal total due to rounding.



(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) Includes manufacturing sales to Merck and third parties for current and prior periods and allocated amounts from revenue hedging activities through the date of Separation.

TABLE 3

Organon & Co.


Sales by geographic area

(Unaudited, $ in millions)

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

($ in millions)

2021

 

2020

 

2021

 

2020

Europe and Canada

$

410

 

 

$

426

 

 

$

1,314

 

 

$

1,286

 

United States

346

 

 

371

 

 

1,035

 

 

1,068

 

Asia Pacific and Japan

287

 

 

354

 

 

874

 

 

1,190

 

China

252

 

 

225

 

 

693

 

 

655

 

Latin America, Middle East, Russia and Africa

238

 

 

228

 

 

595

 

 

649

 

Other(1)

67

 

 

9

 

 

190

 

 

71

 

Revenue

$

1,600

 

 

$

1,613

 

 

$

4,701

 

 

$

4,919

 


(1) Primarily reflects manufacturing sales to Merck and third parties for current and prior periods and allocated amounts from revenue hedging activities through the date of Separation.

TABLE 4

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

($ in millions)

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

2021

 

2020

 

2021

 

2020

Revenue

$

1,600

 

 

$

1,613

 

 

$

4,701

 

 

$

4,919

 

Cost of Goods Sold

609

 

 

535

 

 

1,783

 

 

1,533

 

Gross Profit

991

 

 

1,078

 

 

2,918

 

 

3,386

 

Gross Margin

61.9

%

 

66.8

%

 

62.1

%

 

68.8

%

Amortization

27

 

 

23

 

 

69

 

 

65

 

One-time costs(1)

17

 

 

 

 

27

 

 

 

Stock-based compensation

3

 

 

5

 

 

8

 

 

14

 

Non-GAAP Adjusted Gross Profit
(2)

1,038

 

 

1,106

 

 

3,022

 

 

3,465

 

Non-GAAP Adjusted Gross Margin

64.9

%

 

68.6

%

 

64.3

%

 

70.4

%


(1) One-time costs primarily include inventory discards related to separation re-labeling and other 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 Goods Sold.

TABLE 5

Organon & Co.


Reconciliation of GAAP Net Income from Continuing Operations to Adjusted EBITDA

($ in millions)

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

2021

 

2020

 

2021

 

2020

Net income from continuing operations before income tax

$

389

 

 

$

681

 

 

$

1,293

 

 

$

2,227

 

Depreciation

25

 

 

17

 

 

64

 

 

42

 

Amortization(1)

27

 

 

23

 

 

69

 

 

65

 

Interest expense

98

 

 

 

 

160

 

 

 

EBITDA

539

 

 

721

 

 

1,586

 

 

2,334

 

Restructuring costs

1

 

 

12

 

 

3

 

 

43

 

One-time costs(2)

56

 

 

7

 

 

171

 

 

30

 

Acquired in-process research and development(3)

25

 

 

 

 

25

 

 

 

Stock-based compensation

15

 

 

11

 

 

44

 

 

32

 

Adjusted EBITDA

$

636

 

 

$

751

 

 

$

1,829

 

 

$

2,439

 

Adjusted EBITDA margin

39.8

%

 

46.6

%

 

38.9

%

 

49.6

%


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



(2)One-time costs primarily include cost incurred in connection with the spin-off of Organon as well as $23 million of costs incurred in June 2021 pertaining to the Alydia acquisition. For the three months ended September 30, 2021, approximately $35 million of the one-time costs are recorded in Selling, general and administrative expenses, and approximately $17 million are recorded in Cost of goods sold. For the three months ended September 30, 2020, $7 million of the one-time costs are classified in Selling, general and administrative expenses. For the nine months ended September 30, 2021, approximately $139 million of the one-time costs are recorded in Selling, general and administrative expenses, and approximately $27 million are recorded in Cost of goods sold. For the nine months ended September 30, 2020, $30 million of one-time costs are classified in Selling, general and administrative expenses.



(3) Costs represent upfront licensing payment associated with ObsEva of $25 million during the third quarter 2021, which was recorded in Research and Development Expense.

TABLE 6

Organon & Co.


Reconciliation of GAAP Net Income to Non-GAAP Adjusted Net Income

($ in millions, except per share amounts)

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

2021

 

2020

 

2021

 

2020

Net income from continuing operations before income tax

$

389

 

 

$

681

 

 

$

1,293

 

 

$

2,227

 

Adjustments:

 

 

 

 

 

 

 

Amortization(1)

27

 

 

23

 

 

69

 

 

65

 

Restructuring costs

1

 

 

12

 

 

3

 

 

43

 

One-time costs(2)

56

 

 

7

 

 

171

 

 

30

 

Acquired in-process research and development(3)

25

 

 

 

 

25

 

 

 

Stock-based compensation

15

 

 

11

 

 

44

 

 

32

 

Total Adjustments

124

 

 

53

 

 

312

 

 

170

 

Non-GAAP pre-tax income from continuing operations

513

 

 

734

 

 

1,605

 

 

2,397

 

Taxes on income as reported in accordance with GAAP

66

 

 

121

 

 

144

 

 

347

 

Tax benefit on adjustments

23

 

 

9

 

 

58

 

 

22

 

Tax benefit on GAAP-only discrete items(4)

 

 

 

 

91

 

 

 

Non-GAAP adjusted taxes on income

89

 

 

130

 

 

293

 

 

369

 

Non-GAAP adjusted net income, continuing operations

424

 

 

604

 

 

1,312

 

 

2,028

 

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

$

1.67

 

 

$

2.38

 

 

$

5.17

 

 

$

8.00

 


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



(2)One-time costs primarily include cost incurred in connection with the spin-off of Organon as well as $23 million of costs incurred in June 2021 pertaining to the Alydia acquisition. For the three months ended September 30, 2021, approximately $35 million of the one-time costs are recorded in Selling, general and administrative expenses, and approximately $17 million are recorded in Cost of goods sold. For the three months ended September 30, 2020, $7 million of the one-time costs are classified in Selling, general and administrative expenses. For the nine months ended September 30, 2021, approximately $139 million of the one-time costs are recorded in Selling, general and administrative expenses, and approximately $27 million are recorded in Cost of goods sold. For the nine months ended September 30, 2020, $30 million of one-time costs are classified in Selling, general and administrative expenses.



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



(4) For the three months ended June 30, 2021, the company recorded a tax benefit of approximately $70 million related to a portion of non-US step up in tax basis as a result of its separation from Merck.


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.