Full Press Release Details
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Organon Reports Results for the Third Quarter
Ended September 30, 2023
Jersey City, N.J., November 2, 2023 - Organon (NYSE: OGN)
today announced its results for the third quarter ended September 30, 2023.
"Since spin, we have given new life to Established Brands and
have expanded our pipeline in both Biosimilars and Women's Health," said Kevin Ali, Organon's CEO. "Year to date, all three
of our franchises have delivered growth on a constant currency basis. Over the medium term, we expect to deliver mid-single digit revenue
growth with the power of our existing portfolio. As we move into 2024, we will be working to reduce leverage and continue to add products
that could enhance that growth profile."
Third Quarter 2023 Revenue
| in $ millions | Q3 2023 | Q3 2022 | VPY | VPY ex-FX | ||||||||||||
| Women's Health | $ | 418 | $ | 454 | (8 | )% | (7 | )% | ||||||||
| Biosimilars | 142 | 129 | 10 | % | 10 | % | ||||||||||
| Established Brands | 935 | 915 | 2 | % | 3 | % | ||||||||||
| Other (1) | 24 | 39 | (36 | )% | (38 | )% | ||||||||||
| Revenues | $ | 1,519 | $ | 1,537 | (1 | )% | (1 | )% |
(1) Other includes manufacturing sales to Merck &
Co., Inc., Rahway, NJ, USA and other third parties.
For the third quarter of 2023, total revenue was $1,519 million, a
decrease of 1% on an as-reported basis as well as excluding impact of foreign currency (ex-FX), compared with the third quarter of 2022.
Women's Health revenue decreased 8% on an as-reported basis,
and decreased 7% ex-FX in the third quarter of 2023 compared with the third quarter of 2022 driven primarily by a 23%
ex-FX decrease of NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) which continues to be impacted by generic competition.
Together, the company's fertility products declined 10% ex-FX in the third quarter as unfavorable discount rates in the United
States offset growth in demand. Nexplanon (etonogestrel implant) decreased 3% ex-FX due unfavorable discount rates and a change
in the go-to-market model for the product. These factors were partially offset by revenue from the Jada system, which more
than doubled year over year.
Biosimilars revenue increased
10% on an as-reported basis as well as ex-FX in the third quarter of 2023, compared with the third quarter of 2022. Renflexis
(infliximab-abda) grew 15% ex-FX in the third quarter due to continued demand and strong volume growth in United States and Canada. Ontruzant
(trastuzumab-dttb) grew 34% ex-FX in the third quarter compared to the prior year period
driven by the phasing of a tender in Brazil.
Established Brands revenue increased
2% as-reported and increased 3% ex-FX in the third quarter of 2023, despite the impact of Volume Based Procurement (VBP) initiatives in
Growth in the quarter was driven by Atozet (ezetimibe and atorvastatin calcium), particularly in France, strong demand for
Nasonex (mometasone) and favorable pricing for Dulera (formoterol/fumarate dihydrate) in the United States.
Year to date, the Established Brands franchise grew 1% ex-FX. The company expects the Established Brands franchise to achieve flat to
slightly better revenue growth on a constant currency basis for the full year 2023.
Third Quarter 2023 Profitability
| in $ millions, except per share amounts | Q3 2023 | Q3 2022 | VPY | |||||||||
| Revenues | $ | 1,519 | $ | 1,537 | (1 | )% | ||||||
| Cost of sales | 612 | 551 | 11 | % | ||||||||
| Gross profit | 907 | 986 | (8 | )% | ||||||||
| Non-GAAP Adjusted gross profit (1) | 951 | 1,032 | (8 | )% | ||||||||
| Adjusted EBITDA (1,2) | 447 | 546 | (18 | )% | ||||||||
| Net income | 58 | 227 | (74 | )% | ||||||||
| Non-GAAP Adjusted net income (1) | 223 | 337 | (34 | )% | ||||||||
| Diluted Earnings per Share (EPS) | 0.23 | 0.89 | (74 | )% | ||||||||
| Non-GAAP Adjusted diluted EPS (1) | 0.87 | 1.32 | (34 | )% | ||||||||
| Acquired in-process research & development (IPR&D) and milestones | - | 10 | NM | |||||||||
| Per share impact to diluted EPS from acquired IPR&D and milestones | - | (0.04 | ) | NM |
| Q3 2023 | Q3 2022 | |||||||
| Gross margin | 59.7 | % | 64.2 | % | ||||
| Non-GAAP Adjusted gross margin (1) | 62.6 | % | 67.1 | % | ||||
| Adjusted EBITDA margin (1, 2) | 29.4 | % | 35.5 | % |
Gross margin was 59.7% as-reported and 62.6% on an adjusted basis in
the third quarter of 2023 compared with 64.2% as-reported and 67.1% on an adjusted basis in the third quarter of 2022. The
year-over-year decline in gross margin is primarily due to foreign exchange translation and inflationary manufacturing and distribution
costs. Product mix and pricing erosion were also factors, but to a lesser extent.
EBITDA margin was 29.4% in the
third quarter of 2023 compared with 35.5% in
the third quarter of 2022 primarily due to lower Adjusted gross profit and to a lesser extent an increase in non-GAAP SG&A
expense and loss on foreign exchange translation.
Net income for the third quarter
of 2023 was $58 million, or $0.23 per diluted share, compared with $227 million, or $0.89 per diluted share, in the third quarter of 2022.
Non-GAAP Adjusted net income was $223 million, or $0.87 per diluted share, compared with $337 million, or $1.32 per diluted share, in
2022. The year over year decrease in net income was a result of a lower Adjusted EBITDA, as well as higher interest expense.
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 14, 2023, to stockholders of record at the close of business on November 13, 2023.
As of September 30, 2023, cash and cash equivalents were $414
million, and debt was $8.7 billion.
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.
The company is updating its full year 2023 guidance ranges previously
provided on August 8, 2023. The range for full year 2023 revenue is narrowed and lowered to $6.15 billion to $6.25 billion, which
primarily reflects current foreign currency exchange rates, changes to the go-to-market model for Nexplanon, a slower uptake of Hadlima
(adalimumab-bwwd) and macroeconomic factors in China.
The range for full year Adjusted EBITDA margin is now 30.5% to 31.5%
to reflect a lower gross margin stemming from the impacts of foreign exchange on revenue, unfavorable product mix, and the timing of manufacturing
costs. Organon's financial guidance does not assume an estimate for future IPR&D and milestone payments for business development transactions
Full year 2023 financial guidance is presented below on a non-GAAP
| Previous guidance as of August 8, 2023 | Current guidance | |||
| Revenues | $6.250B-$6.450B | $6.150B-$6.250B | ||
| Adjusted gross margin | Low-mid 60% range | Low 60% range | ||
| SG&A (as % of revenue) | Mid 20% range | Unchanged | ||
| R&D (as % of revenue) | Upper single-digit | Unchanged | ||
| Adjusted EBITDA margin | 31.5%-33.0% | 30.5%-31.5% | ||
| Interest | ~$525 million | Unchanged | ||
| Depreciation | ~$120 million | Unchanged | ||
| Effective non-GAAP tax rate | 17.5%-19.5% | Unchanged | ||
| Fully diluted weighted average shares outstanding | ~257 million | Unchanged |
Organon will host a conference call at 8:30 a.m. Eastern Time
today to discuss its third 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 formed to focus on improving
the health of women throughout their lives. Organon offers more than 60 medicines and products in women's health in addition to
a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon's existing
products produce strong cash flows that support investments in innovation and future growth opportunities in women's health and
biosimilars. 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, New Jersey.
For more information, visit http://www.organon.com
and connect with us on LinkedIn, Instagram, X (formerly known as Twitter)
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 gross margin, Adjusted gross profit, 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.