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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 third quarter 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 third quarter ended September 30, 2021 Jersey City, N.J., November 11, 2021 - Organon (NYSE:

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 third quarter
ended September 30, 2021
Jersey City, N.J., November 11, 2021 - 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 )%
represents manufacturing sales to the company's former parent company and other third parties and pre-spin allocated revenue hedge
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 )%
Tables 4,5 and 6 for reconciliations of GAAP to non-GAAP measures
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.
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
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
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.
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
Last updated: Nov 12, 2021