Full Press Release Details
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Organon Reports Results for the Third Quarter
Ended September 30, 2024
Jersey City, N.J., October 31, 2024 - Organon (NYSE: OGN)
today announced its results for the third quarter ended September 30, 2024.
"In 2024 our commercial execution has been very strong. Our largest
product, Nexplanon, is well positioned to deliver $1 billion of revenue next year and we've added other notable growth drivers
with Emgality and most recently, VTAMA," said Kevin Ali, Organon's chief executive officer. "Further, we have
been extremely disciplined on operating costs and driving Adjusted EBITDA growth in support of achieving $1 billion of free cash flow
before one-time costs for full year 2024."
Third Quarter 2024 Revenue
| in $ millions | Q3 2024 | Q3 2023 | VPY | VPY ex-FX | ||||||||||||
| Women's Health | $ | 440 | $ | 418 | 5 | % | 6 | % | ||||||||
| Biosimilars | 165 | 142 | 16 | % | 17 | % | ||||||||||
| Established Brands | 951 | 935 | 2 | % | 3 | % | ||||||||||
| Other (1) | 26 | 24 | 4 | % | 7 | % | ||||||||||
| Revenues | $ | 1,582 | $ | 1,519 | 4 | % | 5 | % |
Totals may not foot due to rounding and percentages
are computed using unrounded amounts.
(1) Other includes manufacturing sales to third parties.
For the third quarter of 2024, total revenue was
$1.582 billion, up 4% as-reported and up 5% excluding the impact of foreign currency (ex-FX).
Women's Health revenue increased 5% as-reported and 6% ex-FX
in the third quarter of 2024 compared with the third quarter of 2023 primarily driven by 11% ex-FX growth in Nexplanon
(etonogestrel implant). Nexplanon's strong performance was primarily due
to increased demand, favorable price and discount rates in the United States and increased demand in international markets, partially
offset by the timing of tenders in Latin America. The company's fertility portfolio grew 14% ex-FX as a result of increased demand in
the United States, and to a lesser extent, launches in various international markets, partially offset by unfavorable discount rates in
Performance in the Women's Health franchise was partially offset by
sales of NuvaRing (etonogestrel / ethinyl
estradiol vaginal ring), a vaginal contraceptive product, which declined 45% ex-FX during the period due to ongoing generic competition
and the negative impact of increased government discount rates in the United States.
Biosimilars revenue grew 16%
as-reported basis and 17% ex-FX in the third quarter of 2024, compared with the third quarter
of 2023, primarily due to the uptake of Hadlima
(adalimumab-bwwd) since its July 2023 launch in the U.S. Sales of Renflexis
increased 4% ex-FX in the third quarter primarily due to continued
demand growth in the U.S. and Canada partially offset by unfavorable discount rates in the U.S. Sales of Ontruzant
(trastuzumab-dttb) declined 49% ex-FX in the period due to the timing of tenders in Brazil
and lower demand in the U.S. and Europe.
Established Brands revenue grew
2% as-reported 3% ex-FX in the third quarter
of 2024. Contribution from the recent licensing of Emgality (galcanezumab-gnlm)(1), growth in China and recovery
in injectable steroids were the strongest drivers of third quarter's 9% volume growth which more than offset unfavorable pricing
in Japan. The company expects revenue growth in the Established Brands franchise to be approximately
flat for full year 2024 on an ex-FX basis.
trademark registered in the United States in the name of Eli Lilly and Company (used under license).
Third Quarter 2024 Profitability
| in $ millions, except per share amounts | Q3 2024 | Q3 2023 | VPY | |||||||||
| Revenues | $ | 1,582 | $ | 1,519 | 4 | % | ||||||
| Cost of sales | 659 | 612 | 8 | % | ||||||||
| Gross profit | 923 | 907 | 2 | % | ||||||||
| Non-GAAP Adjusted gross profit (1) | 976 | 951 | 3 | % | ||||||||
| Net income | 359 | 58 | 519 | % | ||||||||
| Non-GAAP Adjusted net income (1) | 226 | 223 | 1 | % | ||||||||
| Diluted Earnings per Share (EPS) | 1.38 | 0.23 | 500 | % | ||||||||
| Non-GAAP Adjusted diluted EPS (1) | 0.87 | 0.87 | -% | |||||||||
| Acquired IPR&D and milestones | 51 | - | NM | |||||||||
| Per share impact to diluted EPS from acquired IPR&D and milestones | (0.16 | ) | - | NM | ||||||||
| Adjusted EBITDA (Non-GAAP) (1,2) | 459 | 447 | 3 | % |
| Q3 2024 | Q3 2023 | |||||||
| Gross margin | 58.3 | % | 59.7 | % | ||||
| Non-GAAP Adjusted gross margin (1) | 61.7 | % | 62.6 | % | ||||
| Adjusted EBITDA margin (Non-GAAP) (1, 2) | 29.0 | % | 29.4 | % |
Gross margin was 58.3% as-reported and 61.7% on a non-GAAP adjusted
basis in the third quarter of 2024 compared with 59.7% as-reported and 62.6% on a non-GAAP adjusted basis in the third quarter of 2023.
The lower Adjusted gross margin was primarily related to unfavorable product mix and price.
Net income for the third quarter of 2024 was $359 million, or $1.38
per diluted share, compared with $58 million, or $0.23 per diluted share, in the third quarter of 2023. Non-GAAP Adjusted net income was
$226 million, or $0.87 per diluted share, compared with $223 million, or $0.87 per diluted share, in 2023. GAAP net income benefited from
the release of a valuation allowance in the amount of $210 million against a tax asset of one of the company's Swiss entities.
Non-GAAP Adjusted EBITDA margin was 29.0% in the third quarter of 2024
compared with 29.4% in the third quarter of 2023 primarily due to $51 million of IPR&D expense in the third quarter of 2024 compared
with no such expense in the prior year period. Selling, general and administrative and research and development expenses were down 5%
year over year as a result of the company's cost containment efforts including lower clinical spend and a reduction in headcount related
to restructuring initiatives and lower cost associated with the implementation of the company's ERP system.
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 12, 2024, to stockholders of record at the close of business on November 12, 2024.
As of September 30, 2024, cash and cash equivalents were $763
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.
Full year 2024 financial guidance is presented below on a non-GAAP
basis, except revenue.
| Previous guidance as of August 6, 2024 | Current guidance | |||
| Revenues | $6.250 B - $6.450 B | $6.375 B - $6.425 B | ||
| Adjusted gross margin | 61.0% - 63.0% | ~61.5% | ||
| SG&A | $1.50 B - $1.70 B | $1.55B - $1.60B | ||
| R&D | $400M - $500M | $430M - $470M | ||
| IPR&D | $30M | $81M* | ||
| Total R&D | $430M - $530M | $510M - $550M | ||
| Adjusted EBITDA margin (Non-GAAP) | 31.0% - 33.0% | 30.0% - 31.0% | ||
| Interest | ~$520M | Unchanged | ||
| Depreciation | ~$130M | Unchanged | ||
| Effective non-GAAP tax rate | 18.5% - 20.5% | Unchanged | ||
| Fully diluted weighted average shares outstanding | ~259M | Unchanged |
*Updated R&D expense guidance includes $51 million of IPR&D
and milestone expense incurred in the quarter ended September 30, 2024. R&D guidance does not take into consideration a forward-looking
view of IPR&D and milestone expense.
Organon will host a conference call at 8:30 a.m. Eastern Time
today to discuss its third quarter 2024 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 an independent global healthcare company with a mission
to help improve the health of women throughout their lives. Organon's diverse portfolio offers more than 60 medicines and products
in women's health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition
to Organon's current products, the company invests in innovative solutions and research to drive future
growth opportunities in women's health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical
partners and innovators looking to commercialize their products by leveraging its scale and agile presence in fast growing international
Organon has geographic scope with significant
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) and Facebook.
Cautionary Note Regarding Non-GAAP
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 EBITDA margin,
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