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Karissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 Kate Vossen (732) 675-8448 (201) 275-2711 Edward Barger (267) 614-4669 Organon reports results for the fourth quarter and full year ended

Key Takeaway: Media Contacts: Karissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 Kate Vossen (732) 675-8448 (201) 275-2711 Edward Barger (267) 614-4669 Organon reports results for the fourth quarter and full year ended December 31, 2021 Nexplanon (etonogestrel implant), fert

Full Press Release Details

Media Contacts: Karissa Peer Investor Contacts: Jennifer Halchak
(614) 314-8094 Kate Vossen (732) 675-8448 (201) 275-2711 Edward Barger (267) 614-4669
Organon reports results for the fourth quarter
and full year ended December 31, 2021
Nexplanon (etonogestrel
implant), fertility, biosimilars grew double digits for full year
Jersey City, N.J., February 17,
2022 - 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 )%
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
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.
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 )%
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.
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
Last updated: Feb 17, 2022