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 first quarter
ended March 31, 2022
Jersey City, N.J., May 5, 2022 - Organon (NYSE: OGN) (the "company"),
today announced its results for the first quarter ended March 31, 2022.
"The first quarter marked a solid start to the year. We continued
to expand our Women's Health offerings by acquiring the rights to Marvelon (ethinylestradiol, desogestrel) and Mercilon
(ethinylestradiol, desogestrel) in certain markets, as well as by entering into a licensing agreement to commercialize XaciatoTM
(clindamycin phosphate) vaginal gel," said Kevin Ali, Organon's CEO. "Additionally, with LOE risk in the Established
Brands business largely behind us, together with continued focus on maximizing the potential of these well-known brands, we are starting
to see the stability we knew was possible in that franchise."
First quarter 2022 revenue
| in $ millions | Q1 2022 | Q1 2021 | VPY | VPY ex-FX | ||||||||||||
| Women's Health | $ | 378 | $ | 399 | (5 | )% | (3 | )% | ||||||||
| Biosimilars | 99 | 81 | 22 | % | 25 | % | ||||||||||
| Established Brands | 1,053 | 957 | 10 | % | 15 | % | ||||||||||
| Other (1) | 37 | 69 | (45 | )% | (46 | )% | ||||||||||
| Revenue | $ | 1,567 | $ | 1,506 | 4 | % | 8 | % |
(1) Other includes manufacturing sales to Merck &
Co., Inc., Rahway, NJ, USA and other third parties, and allocated amounts from pre-spin revenue hedging activities.
Total net revenue was $1,567 million for the first quarter of 2022,
an increase of 4% as-reported and an increase of 8% excluding the impacts of foreign currency (ex-FX), compared with the first quarter
Women's Health declined 5% as-reported and declined 3% ex-FX
in the first quarter 2022 compared with the first quarter of 2021, driven by Nuvaring (etonogestrel/ethinyl estradiol vaginal
ring) which declined 6% ex-FX in the first quarter of 2022 compared with the first quarter of 2021, and the Authorized Generic of Nuvaring
(AG), both of which continue to be impacted by generic competition. The decline in the Women's Health portfolio was also due
to a 5% ex-FX decline in Nexplanon (etonogestrel implant) which was driven by distributors' buying patterns in the United
States in prior periods, partially offset by strong performance in Latin America and volume growth in Europe. The decline in the company's
contraception portfolio was partially offset by double digit growth in the fertility franchise, led by Follistim AQ (follitropin
beta injection), which grew 20% ex-FX, primarily due to higher demand in China and volume growth in the United States.
Biosimilars revenue grew 22% as-reported and grew 25% ex-FX in the
first quarter 2022 compared with first quarter 2021. Organon's current portfolio includes certain immunology and oncology treatments.
All five of the biosimilars in Organon's portfolio have launched in certain countries globally, including two biosimilars, Renflexis
(infliximab-abda) and Ontruzant (trastuzumab-dttb), in the United States. Renflexis grew 21% ex-FX in the first quarter
of 2022 compared with the first quarter of 2021 primarily due to continued demand growth in the United States since its launch in 2017.
Ontruzant grew 5% ex-FX driven by continued uptake in the United States since its launch in July 2020, partially offset by competitive
pressures in Europe.
Established Brands represents a broad portfolio of well-known medicines,
which are generally beyond market exclusivity, including leading brands in cardiovascular, respiratory, dermatology and non-opioid pain
management, and for which generic competition varies by market. The portfolio's exposure to loss of exclusivity (LOE) risk peaked in
2021 and no longer represents a significant impediment to stable performance in the Established Brands franchise. Revenue for Established
Brands increased 10% as-reported and increased 15% ex-FX in the first quarter of 2022 compared with the first quarter of 2021. The first
quarter of 2022 benefited from fluctuations in demand in certain markets, including a temporary supply issue currently impacting several
competitors in the Japanese market. This compares to weaker performance in Japan in the first quarter of 2021 due to anticipated government-led
price actions in that market and lingering effects from the LOE of Zetia (ezetimibe). Additionally, the first quarter of
last year was negatively impacted by the implementation of the third round of Volume Based Procurement (VBP) initiatives in China, as
well as by LOE exposure. There was minimal impact from these factors in the first quarter of 2022. Volume growth in products in China,
Europe and the LAMERA region also contributed to the favorable performance of Established Brands in the first quarter of 2022.
First quarter 2022 profitability
Organon was spun-off from Merck & Co., Inc., Rahway, NJ, USA on
June 2, 2021. Financial results during the pre-spin period were presented on the carve-out basis of accounting and do not purport to
reflect what Organon's financial results would have been had Organon operated as a standalone public company. Therefore, with the
exception of Revenue, financial results for the periods ending March 31, 2021 and March 31, 2022 are not meaningfully comparable.
| in $ millions, except per share amounts | Q1 2022 | Q1 2021 pre-spin | VPY | |||||||||
| Revenue | $ | 1,567 | $ | 1,506 | 4 | % | ||||||
| Cost of sales | 561 | 591 | (5 | )% | ||||||||
| Gross profit | 1,006 | 915 | 10 | % | ||||||||
| Non-GAAP Adjusted gross profit (*) | 1,042 | 937 | 11 | % | ||||||||
| Adjusted EBITDA (*) | 647 | 566 | 14 | % | ||||||||
| Net Income, continuing operations (*) | 348 | 395 | (12 | )% | ||||||||
| Non-GAAP Adjusted net income, continuing operations (*) | 420 | 451 | (7 | )% | ||||||||
| Diluted Earnings per Share, continuing operations | 1.36 | 1.56 | (13 | )% | ||||||||
| Non-GAAP Adjusted Diluted Earnings per Share, continuing operations (*) | 1.65 | 1.78 | (7 | )% | ||||||||
| Gross margin | 64.2 | % | 60.8 | % | ||||||||
| Non-GAAP adjusted gross margin (*) | 66.5 | % | 62.2 | % | ||||||||
| Adjusted EBITDA margin (*) | 41.3 | % | 37.6 | % |
(*) See Tables 4,5 and 6 for reconciliations
of GAAP to non-GAAP financial measures
Gross margin was 64.2% as-reported and 66.5% on an adjusted basis
in the first quarter of 2022 compared with 60.8% as-reported and 62.2% on an adjusted basis in the first quarter of 2021. The year-over-year
improvement in gross margin primarily reflects reduced lower margin supply sales in the first quarter of this year.
Adjusted EBITDA margin was 41.3% in the first quarter of 2022 compared
with 37.6% in the first quarter of 2021. The improvement in Adjusted EBITDA margin is largely driven by higher Adjusted gross profit
in the period, and also reflects lower SG&A costs compared with the prior year, pre-spin period, partially offset by increased research
and development costs in the first quarter of 2022 associated with the company's recent acquisitions of clinical stage assets. Adjusted
EBITDA margin in the first quarter of 2022 incorporates SG&A costs that are expected to be at the lowest point for full year 2022.
Net income from continuing operations for the first quarter of 2022
was $348 million, or $1.36 per diluted share, compared with $395 million, or $1.56 per diluted share, in the first quarter of 2021. Non-GAAP
Adjusted net income from continuing operations was $420 million, or $1.65 per diluted share, compared with $451 million, or $1.78 per
diluted share, in 2021.
Today, Organon's Board of Directors declared a quarterly dividend
of $0.28 for each issued and outstanding share of the company's common stock. The dividend is payable on June 16, 2022 to
stockholders of record at the close of business on May 16, 2022.
As of March 31, 2022, cash and cash equivalents were $694 million,
and debt was $9,094 million, resulting in net debt of $8,400 million.
Organon does not provide GAAP financial measures on a forward-looking
basis because the company cannot predict with reasonable certainty and without unreasonable effort, the ultimate outcome of legal proceedings,
unusual gains and losses, the occurrence of matters creating GAAP tax impacts, and acquisition-related expenses. These items are uncertain,
depend on various factors, and could be material to Organon's results computed in accordance with GAAP.
Beginning in 2022, Organon will no longer exclude expenses for upfront
and milestone payments related to collaborations and licensing agreements, or charges related to pre-approval assets obtained in transactions
accounted for as asset acquisitions from its non-GAAP results. These changes are being made to align with views expressed by the U.S.
Securities and Exchange Commission. There are no such expenses or charges for in-process research and development for the periods ended
March 31, 2022 or March 31, 2021. Relevant prior periods have been recast to reflect these changes and can be found in Tables 7 and 8
of this press release.
Organon's financial guidance does not assume an estimate for future
in-process research and development for business development transactions not yet executed.
The company affirmed the full year 2022 financial guidance previously
provided on February 17, 2022, which is presented on a non-GAAP basis.
| Previous guidance | Current guidance | |||
| Revenue | $6.1B - $6.4B | Unchanged | ||
| Adjusted gross margin | Mid 60% | Unchanged | ||
| SG&A (as % of revenue) | Mid 20% | Unchanged | ||
| R&D (as % of revenue) | Mid to upper single digit | Unchanged | ||
| Adjusted EBITDA margin | 34%-36% | Unchanged | ||
| Interest | ~$400 million | Unchanged | ||
| Depreciation | $100-$115 million | Unchanged | ||
| Effective Non-GAAP tax rate | 17.5%-19.5% | Unchanged | ||
| Fully diluted weighted avg. shares outstanding | ~255 million | Unchanged |
Organon will host a conference call at 8:30 a.m. Eastern Time today
to discuss its first quarter 2022 financial results. To listen to the event and view the presentation slides via webcast, join from the
Organon Investor Relations website at https://www.organon.com/investor-relations/. A replay of the webcast will be available approximately
two hours after the conclusion of the live event on the company's website. Institutional investors and analysts interested in participating
in the call must register in advance using conference ID# 6895016 and by clicking on this link: http://www.directeventreg.com/registration/event/6895016.
Following registration, participants will receive a confirmation email containing details on how to join the conference call, including
dial-in information and a unique passcode and registrant ID. Pre-registration will allow participants to bypass an operator and be placed
directly into the call.
Organon is a global healthcare company, formed through a spin-off
from Merck & Co., Inc., Rahway, NJ, USA (NYSE: MRK), to focus on improving the health of women throughout their lives. Organon has
a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women's health portfolio coupled
with an expanding biosimilars business and stable franchise of established medicines, Organon's products produce strong cash flows
that will support investments in innovation and future growth opportunities in women's health. In addition, Organon is pursuing
opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence
in fast growing international markets.
Organon has a global footprint with significant scale and geographic
reach, world-class commercial capabilities, and approximately 9,300 employees with headquarters located in Jersey City, New Jersey.