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Karissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 (201) 275-2711 Kate Vossen Alex Arzeno (732) 675-8448 (203) 550-3972 Organon Reports Results for the First Quarter Ended

Key Takeaway: Organon reported its first quarter 2023 financial results, showing a decrease in total revenue to $1.538 billion, a drop of 2% year-over-year. Notably, the company achieved growth in both Women's Health and Biosimilars product lines, though Established Brands faced challenges resulting in a 5% revenue decline. Despite the revenue decrease, the company maintains a positive outlook with a continued focus on capital allocation for strategic investments. Organon also declared a quarterly dividend of $0.28 per share, payable on June 15, 2023.

Market Sentiment Analysis

POSITIVE FACTORS

  • Achieved sixth consecutive quarter of product sales growth.
  • Strong performance in Women's Health and Biosimilars segments.
  • Continued positive cash flow and strategic capital allocation.

CONCERNS & RISKS

  • Total revenue decreased by 2% year-over-year.
  • Net income dropped by 49% compared to the previous year.
  • Revenue decline in Established Brands due to competitive pressures and procurement initiatives.

Full Press Release Details

Media Contacts: Karissa Peer Investor Contacts: Jennifer Halchak
(614) 314-8094 (201) 275-2711
Kate Vossen Alex Arzeno
(732) 675-8448 (203) 550-3972
Organon Reports Results for the First Quarter
Ended March 31, 2023
Jersey City, N.J., May 4, 2023 - Organon (NYSE: OGN) today
announced its results for the first quarter ended March 31, 2023.
"The first quarter of 2023 represents the sixth consecutive quarter
of constant currency product sales growth, with all three franchises positively contributing to performance," said Kevin Ali, Organon's
CEO. "The Established Brands franchise, which represents two-thirds of our business, continues to demonstrate its durability. The
associated predictability of cash flows enables us to take a balanced approach to capital allocation, continuing to deploy capital for
strategic investments that will position the company for future growth, as well as to opportunistically reduce debt, as we did during
First Quarter 2023 revenues
in $ millions Q1 2023 Q1 2022 VPY VPY ex-FX
Women's Health $ 381 $ 378 1 % 3 %
Biosimilars 116 99 18 % 20 %
Established Brands 1,002 1,053 (5 )% 1 %
Other (1) 39 37 3 % 2 %
Revenues $ 1,538 $ 1,567 (2 )% 3 %
(1) Other includes manufacturing sales to Merck &
Co., Inc., Rahway, NJ, USA and other third parties.
For the first quarter of 2023, total revenue was $1,538 million, a
decrease of 2% as-reported and an increase of 3% excluding the impact of foreign currency (ex-FX), compared with the first quarter of
Women's Health revenue grew 1% on an as-reported basis, and increased
3% ex-FX in the first quarter of 2023 compared with the first quarter of 2022 driven primarily by strong performance in oral contraceptives
Marvelon (ethinylestradiol, desogestrel) and Mercilon (ethinylestradiol, desogestrel) for which Organon gained
rights in selected territories in Southeast Asia and China during 2022. During the quarter, Nexplanon (etonogestrel implant),
a long-acting reversible contraceptive declined 1% ex-FX primarily due to the impact of distributors' buying patterns in prior periods.
Follistim AQ (follitropin beta injection) declined 7% ex-FX primarily related to COVID-related disruptions in China that have
hampered access to fertility treatments in that market, as well as an unfavorable shift in customer mix and associated discount rates
in the United States that was partially offset by strong product demand.
Biosimilars revenue increased 18% as-reported and 20% ex-FX in the
first quarter 2023, compared with the first quarter of 2022 primarily driven by Renflexis (infliximab-abda) which grew 34%
ex-FX due to continued demand growth in the United States and Canada as well as Brenzys (etanercept) which grew 36% ex-FX
as a result of timing of tenders in Brazil. Ongoing competitive pressures in Europe more than offset strong U.S. growth in Ontruzant
Established Brands revenue decreased 5% as-reported and increased 1%
ex-FX in the first quarter of 2023, compared with the first quarter of 2022 despite 1) the impact of Volume Based Procurement (VBP) initiatives
in China which as of November 2022 included Zetia (ezetimibe) (marketed in most countries outside of the United States
as Ezetrol ) and 2) supply interruptions of Diprospan , Celestone Chronodose , and Celestone Soluspan
stemming from the company's market action taken in January for those injectable steroid products. Strong performance in China
and in the APJ region (Asia Pacific/Japan), primarily in markets outside Japan, were the most significant offsets to these factors
First Quarter 2023 Profitability
in $ millions, except per share amounts 2023 2022 VPY
Revenues $ 1,538 $ 1,567 (2 )%
Cost of sales 580 561 3 %
Gross profit 958 1,006 (5 )%
Non-GAAP Adjusted gross profit (1) 1,003 1,042 (4 )%
Adjusted EBITDA (1,2) 518 647 (20 )%
Net Income 177 348 (49 )%
Non-GAAP Adjusted net income (1) 276 420 (34 )%
Diluted Earnings per Share (EPS) 0.69 1.36 (49 )%
Non-GAAP Adjusted diluted EPS (1) 1.08 1.65 (35 )%
Acquired in-process research & development (IPR&D) and milestones 8 - NM
Per share impact to diluted EPS from acquired IPR&D and milestones 0.03 - NM
2023 2022
Gross margin 62.3 % 64.2 %
Non-GAAP Adjusted gross margin (1) 65.2 % 66.5 %
Adjusted EBITDA margin (1,2) 33.7 % 41.3 %
Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures
EBITDA and Adjusted EBITDA margin include $8 million in the first quarter of 2023 related to acquired IPR&D and milestones
Gross margin was 62.3% as-reported and 65.2% on an adjusted basis in
the first quarter of 2023 compared with 64.2% as-reported and 66.5% on an adjusted basis in the first quarter of 2022. The
year-over-year decline in gross margin is primarily due to product mix as well as inflationary pressure that impacted distribution
and employee-related costs.
EBITDA margin was 33.7% in the first quarter of 2023 compared
to 41.3% in the first quarter of 2022. Higher promotional and employee-related costs as well
as increasing R&D spend associated with the company's recent acquisitions of clinical stage assets were the primary contributors to
the decline in Adjusted EBITDA margin year over year.
Net income for the first quarter of 2023 was $177 million, or $0.69
per diluted share, compared with $348 million, or $1.36 per diluted share, in the first quarter of 2022. Non-GAAP Adjusted net income
was $276 million, or $1.08 per diluted share, compared with $420 million, or $1.65 per diluted share, in 2022. The year over year decline
in net income was a result of lower Adjusted EBITDA as well as increased interest expense (related to higher interest rates and interest
expense for accelerated amortization of debt fees and discounts as part of the $250 million voluntary prepayment on the U.S. dollar-denominated
term loan), a higher effective tax rate and the impact of exchange losses driven by the fluctuations in foreign currency.
Today, Organon's Board of Directors declared a quarterly dividend
of $0.28 for each issued and outstanding share of the company's common stock. The dividend
is payable on June 15, 2023, to stockholders of record at the close of business on May 15, 2023.
As of March 31, 2023, cash and cash equivalents were $459 million,
and debt was $8.7 billion. Total debt as of March 31, 2023 reflects a discretionary first quarter prepayment of $250 million on the
company's U.S. dollar-denominated term loan.
Organon does not provide GAAP financial measures on a forward-looking
basis because the company cannot predict with reasonable certainty and without unreasonable effort, the ultimate outcome of legal proceedings,
unusual gains and losses, the occurrence of matters creating GAAP tax impacts, and acquisition-related expenses. These items are uncertain,
depend on various factors, and could be material to Organon's results computed in accordance with GAAP. Organon's financial guidance
does not assume an estimate for future in-process research and development for business development transactions not yet executed.
Full year 2023 financial guidance is presented below on a non-GAAP
Previous guidance as of February 16, 2023 Current guidance
Revenues $6.150 billion - $6.450 billion Unchanged
Adjusted gross margin Low-mid 60% range Unchanged
SG&A (as % of revenue) Mid 20% range Unchanged
R&D 1 (as % of revenue) Upper single-digit Unchanged
Adjusted EBITDA margin 31.0%-33.0% Unchanged
Interest ~$510 million ~$515 million
Depreciation ~$130 million Unchanged
Effective non-GAAP tax rate 19.0% - 21.0% Unchanged
Fully diluted weighted average shares outstanding ~255 million ~257 million
Organon will host a conference call at 8:30 a.m. Eastern Time
today to discuss its first quarter 2023 financial results. To listen to the event and view the presentation slides via webcast, join from
the Organon Investor Relations website at https://www.organon.com/investor-relations/events-and-presentations/. A replay of the webcast
will be available approximately two hours after the conclusion of the live event on the company's website. Institutional investors
and analysts interested in participating in the call must register in advance by clicking on this link:
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 with a focus on improving the
health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas.
Led by the women's health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines,
Organon's products produce strong cash flows that will support investments in innovation and future growth opportunities in women's
health. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their
products by leveraging its scale and presence in fast growing international markets. Organon has a global footprint with significant scale
and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City,
For more information, visit http://www.organon.com and connect with
us on LinkedIn, Instagram, Twitter and Facebook.
Cautionary Note Regarding Non-GAAP Financial Measures
This press release contains "non-GAAP financial measures,"
which are financial measures that either exclude or include amounts that are correspondingly not excluded or included in the most directly
comparable measures calculated and presented in accordance with U.S. generally accepted accounting principles ("GAAP"). Specifically,
the company makes use of the non-GAAP financial measures Adjusted EBITDA, Adjusted net income, and Adjusted diluted EPS, which are not
recognized terms under GAAP and are presented only as a supplement to the company's GAAP financial statements. This press release
also provides certain measures that exclude the impact of foreign exchange. We calculate foreign exchange by converting our current-period
local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period
results. The company believes that these non-GAAP financial measures help to enhance an understanding of the company's financial
performance. However, the presentation of these measures has limitations as an analytical tool and should not be considered in isolation,
or as a substitute for the company's results as reported under GAAP. Because not all companies use identical calculations, the presentations
of these non-GAAP measures may not be comparable to other similarly titled measures of other companies. You should refer to Table 4 and
Table 5 of this press release for relevant definitions and reconciliations of non-GAAP financial measures contained herein to the most
directly comparable GAAP measures.
In addition, the company's full-year 2023 guidance measures (other
than revenue) are provided on a non-GAAP basis because the company is unable to reasonably predict certain items contained in the GAAP

Frequently Asked Questions

What were Organon's total revenues for Q1 2023?

Organon's total revenues for Q1 2023 were $1,538 million.

How did Women's Health revenue perform in Q1 2023?

Women's Health revenue grew 1% on an as-reported basis in Q1 2023.

What is the adjusted EBITDA margin for Q1 2023?

The adjusted EBITDA margin for Q1 2023 was 33.7%.

What dividend did Organon declare for Q1 2023?

Organon declared a quarterly dividend of $0.28 per share.

What is the outlook for Organon's full year 2023 revenues?

Organon expects full year 2023 revenues between $6.150 billion and $6.450 billion.

Last updated: May 4, 2023