Full Press Release Details
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Organon Reports Results for the First Quarter
Ended March 31, 2024
Jersey City, N.J., May 2, 2024 - Organon (NYSE: OGN) today
announced its results for the first quarter ended March 31, 2024.
"We entered this year with a clear focus: to deliver our 2024
financial targets while staying true to our mission of improving the health of women, and the first quarter was a very solid start,"
said Kevin Ali, Organon's Chief Executive Officer. "We remain confident in our ability to deliver our third year of revenue growth
on a constant currency basis and we remain committed to delivering full-year non-GAAP Adjusted EBITDA margins that are in line with last
First Quarter 2024 Revenue
| in $ millions | Q1 2024 | Q1 2023 | VPY | VPY ex-FX | ||||||||||||
| Women's Health | $ | 422 | $ | 381 | 11 | % | 12 | % | ||||||||
| Biosimilars | 170 | 116 | 46 | % | 46 | % | ||||||||||
| Established Brands | 1,001 | 1,002 | -% | 2 | % | |||||||||||
| Other (1) | 29 | 39 | (27 | )% | (29 | )% | ||||||||||
| Revenues | $ | 1,622 | $ | 1,538 | 5 | % | 7 | % |
(1) Other includes manufacturing sales to third parties.
For the first quarter of 2024, total revenue
was $1,622 million, an increase of 5% on an as-reported basis and an increase of 7% excluding the impact of foreign currency (ex-FX),
compared with the first quarter of 2023.
Women's Health revenue increased 11% on an as-reported basis,
and increased 12% ex-FX in the first quarter of 2024 compared with the first quarter of 2023 primarily driven by 34% ex-FX growth in
Nexplanon (etonogestrel implant). Nexplanon's strong performance was primarily due to the favorable year-over-year
comparison of customer purchasing patterns associated with the timing of U.S list-price adjustments, coupled with favorable price and
discount rates in the U.S. and the favorable timing of tenders to markets outside of the U.S. Worldwide sales of the Jada system,
a device intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management
is warranted, nearly doubled compared with the prior year period, benefiting from continued uptake in the United States following the
product's launch in early 2022. Performance in the Women's Health franchise was partially offset by sales of NuvaRing (estonogestrel
/ ethinyl estradiol vaginal ring), a vaginal contraceptive product, which declined 19% ex-FX during the period due to ongoing generic
competition. The fertility portfolio was down 2% ex-FX in the first quarter, following a very strong fourth quarter of 2023 for Follistim
AQ (follitropin beta injection) which benefited from a one-time buy-in associated with the planned exit of a temporary spin-off
related commercial arrangement in the U.S. and increased demand that was largely tied to onboarding a new customer.
revenue grew 46% on an as-reported basis and 46% ex-FX in the first quarter of 2024, compared with the first quarter of 2023. This revenue
growth was primarily driven by Ontruzant (trastuzumab-dttb), which benefited from incremental demand from a tender in Brazil.
Renflexis (infliximab-abda) grew 12% ex-FX primarily due to continued demand growth in the U.S and Canada partially
offset by unfavorable rates in the U.S. Worldwide revenue of Hadlima (adalimumab-bwwd) was $30 million during the
three months ended March 31, 2024, compared with $5 million in the prior year period, primarily related to continued uptake following
the product's July 2023 launch in the U.S.
Established Brands revenue was flat on an as-reported basis and grew
2% ex-FX in the first quarter of 2024. Contribution from the recent licensing of Emgality (galcanezumab) and RayvowTM
(lasmiditan)(1, 2), together with a recovery in certain injectable steroid products following last year's market
action offset the impacts of Volume Based Procurement initiatives in China. Performance was equally driven by growth in volume and price.
The company expects revenue growth in the Established Brands franchise to be about flat for full year 2024 on an ex-FX basis.
(1) Emgality is a trademark registered in the United States
in the name of Eli Lilly and Company (used under license).
(2) Rayvow is a registered trademark of Eli Lilly in the
European Union and other countries (used under license).
First Quarter 2024 Profitability
| in $ millions, except per share amounts | Q1 2024 | Q1 2023 | VPY | |||||||||
| Revenues | $ | 1,622 | $ | 1,538 | 5 | % | ||||||
| Cost of sales | 665 | 580 | 15 | % | ||||||||
| Gross profit | 957 | 958 | -% | |||||||||
| Non-GAAP Adjusted gross profit (1) | 1,007 | 1,003 | -% | |||||||||
| Net income | 201 | 177 | 14 | % | ||||||||
| Non-GAAP Adjusted net income (1) | 315 | 276 | 14 | % | ||||||||
| Diluted Earnings per Share (EPS) | 0.78 | 0.69 | 13 | % | ||||||||
| Non-GAAP Adjusted diluted EPS (1) | 1.22 | 1.08 | 13 | % | ||||||||
| Acquired in-process research & development (IPR&D) and milestones | 15 | 8 | - | |||||||||
| Per share impact to diluted EPS from acquired IPR&D and milestones | (0.05 | ) | (0.03 | ) | - | |||||||
| Adjusted EBITDA (Non-GAAP) (1,2) | 538 | 518 | 4 | % | ||||||||
| Q1 2024 | Q1 2023 | |||||||||||
| Gross margin | 59.0 | % | 62.3 | % | ||||||||
| Non-GAAP Adjusted gross margin (1) | 62.1 | % | 65.2 | % | ||||||||
| Adjusted EBITDA margin (Non-GAAP) (1, 2) | 33.2 | % | 33.7 | % |
Gross margin was 59.0% as-reported and 62.1% on a non-GAAP adjusted
basis in the first quarter of 2024 compared with 62.3% as-reported and 65.2% on a non-GAAP adjusted basis in the first quarter of 2023.
The lower non-GAAP Adjusted gross margin was primarily related to unfavorable product mix, foreign exchange translation and higher inflation
impacts to material and distribution costs.
Net income for the first quarter of 2024 was $201 million, or $0.78
per diluted share, compared with $177 million, or $0.69 per diluted share, in the first quarter of 2023. Non-GAAP Adjusted net income
was $315 million, or $1.22 per diluted share, compared with $276 million, or $1.08 per diluted share, in 2023.
Non-GAAP Adjusted EBITDA margin was 33.2% in the first quarter of
2024 compared with 33.7% in the first quarter of 2023 primarily due to cost containment initiatives targeting operating expenses, particularly
in research and development, that were offset by higher cost of goods sold.
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 13, 2024, to
stockholders of record at the close of business on May 13, 2024.
As of March 31, 2024, cash and cash equivalents were $575 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 February 15, 2024 | Current guidance | |||
| Revenues | $6.2B - $6.5B | Unchanged | ||
| Adjusted gross margin | 61.0% - 63.0% | Unchanged | ||
| SG&A | $1.5B - $1.7B | Unchanged | ||
| R&D* | $400M - $500M | Unchanged | ||
| Adjusted EBITDA margin (Non-GAAP) | 31.0% - 33.0% | Unchanged | ||
| Interest | ~$520M | Unchanged | ||
| Depreciation | ~$130M | Unchanged | ||
| Effective non-GAAP tax rate | 18.5% - 20.5% | Unchanged | ||
| Fully diluted weighted average shares outstanding | ~259M | Unchanged |
*R&D expense includes $15 million of IPR&D and milestone
expense year-to-date March 31, 2024. R&D guidance does not take into consideration a forward looking view of IPR&D and milestone
Organon will host a conference call at 8:30 a.m. Eastern Time
today to discuss its first 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 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.
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 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 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 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. Please refer to Table 4 and Table 5 of this press release for additional information,