Full Press Release Details
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Organon Reports Results for the First Quarter
Ended March 31, 2025
Company affirms full year 2025 financial guidance,
resets dividend payout to strengthen capital structure
Jersey City, N.J., May 1, 2025 - Organon (NYSE: OGN) today
announced its results for the first quarter ended March 31, 2025.
"We have reset our capital allocation priorities to accelerate
progress towards deleveraging, enabling a path to achieve a net leverage ratio of below 4.0x by year-end. Over the last year, we have
established a leaner, more fit-for-purpose cost structure while increasing revenue contribution from our core growth drivers. By deleveraging
more rapidly, we will continue to strengthen the future prospects of the company. Over time, this will position us to execute more of
the compelling business development we've done to date, bringing in additional growth drivers to our portfolio, while maintaining
lower leverage," said Kevin Ali, Organon's CEO. "With key growth drivers, Nexplanon and Vtama, on track
to achieve their revenue objectives for the year, we are affirming our full year revenue and Adjusted EBITDA margin guidance, as well
as our target of generating over $900 million of free cash flow before one-time costs."
First Quarter 2025 Revenue
| in $ millions | Q1 2025 | Q1 2024 | VPY | VPY ex-FX | ||||||||||||
| Women's Health | $ | 463 | $ | 422 | 10 | % | 12 | % | ||||||||
| Biosimilars | 141 | 170 | (17 | )% | (15 | )% | ||||||||||
| Established Brands | 887 | 1,001 | (11 | )% | (8 | )% | ||||||||||
| Other (1) | 22 | 29 | (23 | )% | (19 | )% | ||||||||||
| Revenue | $ | 1,513 | $ | 1,622 | (7 | )% | (4 | )% |
Totals may not foot due to rounding and percentages
are computed using unrounded amounts.
(1) Other includes manufacturing sales to third parties.
the first quarter of 2025, total revenue was $1.513 billion, down 7% on an as-reported basis and down 4% year-over-year excluding
the impact of foreign currency (ex-FX).
Health revenue increased 10% as-reported and 12% ex-FX in the first quarter of 2025, compared with the first quarter of 2024. Nexplanon
(etonogestrel implant) growth of 14% ex-FX , as well as a favorable year-over-year comparison in Follistim AQ (follitropin
beta injection) related to the exit of a spin-related interim operating model agreement in the United States, together more than offset
a 41% ex-FX decline in NuvaRing (etonogestrel / ethinyl estradiol vaginal ring) attributable to ongoing generic competition.
revenue declined 17% as-reported and 15% ex-FX in the first quarter of 2025, compared with
the first quarter of 2024, primarily due to the return to normalized levels of the
contracted volume of Ontruzant (trastuzumab-dttb) in Brazil, a 17% ex-FX decline
in Renflexis (infliximab-abda) attributable
to competitive pricing pressure in the U.S. associated with the maturity of the product, and the timing of international tenders for Brenzys
(etanercept). Performance was partially offset by sales of Hadlima (adalimumab-bwwd)
that have continued to ramp up since its July 2023 launch in the U.S.
Brands revenue declined 11% as-reported and 8% ex-FX
in the first quarter of 2025. Revenue contribution of Emgality (1) (galcanezumab-gnlm) and Vtama (2) (tapinarof),
partially offset the impact of the loss of exclusivity ("LOE") of Atozet (ezetimibe and atorvastatin) in key
markets in Europe and lower sales of Singulair, particularly in China and Japan.
(1) Organon acquired certain European licensing and distribution
rights to Emgality and Rayvow from Eli Lilly beginning in early 2024. Emgality and Rayvow are registered trademarks
of Eli Lilly in the European Union and other countries (used under license).
(2) Vtama was acquired as part of Organon's acquisition
of Dermavant Sciences Ltd. ("Dermavant") which closed on October 28, 2024.
First Quarter 2025 Profitability
| in $ millions, except per share amounts | Q1 2025 | Q1 2024 | VPY | |||||||||
| Revenues | $ | 1,513 | $ | 1,622 | (7 | )% | ||||||
| Cost of sales | 672 | 665 | 1 | % | ||||||||
| Gross profit | 841 | 957 | (12 | )% | ||||||||
| Non-GAAP Adjusted gross profit (1) | 934 | 1,007 | (7 | )% | ||||||||
| Net income | 87 | 201 | (57 | )% | ||||||||
| Non-GAAP Adjusted net income (1) | 265 | 315 | (16 | )% | ||||||||
| Diluted Earnings per Share (EPS) | 0.33 | 0.78 | (58 | )% | ||||||||
| Non-GAAP Adjusted diluted EPS (1) | 1.02 | 1.22 | (16 | )% | ||||||||
| Acquired in-process research & development (IPR&D) and milestones | 6 | 15 | -% | |||||||||
| Adjusted EBITDA (Non-GAAP) (1, 2) | 484 | 538 | (10 | )% | ||||||||
| Q1 2025 | Q1 2024 | |||||||||||
| Gross margin | 55.6 | % | 59.0 | % | ||||||||
| Non-GAAP Adjusted gross margin (1) | 61.7 | % | 62.1 | % | ||||||||
| Adjusted EBITDA margin (Non-GAAP) (1, 2) | 32.0 | % | 33.2 | % |
Gross margin was 55.6% as-reported and 61.7% on a non-GAAP adjusted
basis in the first quarter of 2025, compared with 59.0% as-reported and 62.1% on a non-GAAP adjusted basis in the first quarter of 2024.
Lower reported gross margin in the first quarter was due to higher year-over-year amortization expense related to the acquisition of intangibles
in the prior year. The year-over-year decline in non-GAAP Adjusted gross margin was primarily due to unfavorable price.
Net income for the first quarter of 2025 was $87 million, or $0.33
per diluted share, compared with $201 million, or $0.78 per diluted share, in the first quarter of 2024. For the first quarter of 2025,
non-GAAP Adjusted net income was $265 million, or $1.02 per diluted share, compared with $315 million, or $1.22 per diluted share, in
Non-GAAP Adjusted EBITDA margin was 32.0% in the first quarter of 2025
compared with 33.2% in the first quarter of 2024. The lower Adjusted EBITDA margin was primarily driven by the decline in Adjusted gross
profit; non-GAAP operating expenses were down 1% year-over-year.
Today, Organon's Board of Directors declared a quarterly dividend
of $0.02 for each issued and outstanding share of the company's common stock. This is a revision from the company's prior quarterly
dividend rate of $0.28 per share. The dividend is payable on June 12, 2025, to stockholders of record at the close of business
As of March 31, 2025, cash and cash equivalents were $547 million,
and debt was $8.96 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 2025 financial guidance is presented below on a non-GAAP
basis, except revenue.
| Previous Guidance as of February 13, 2025 | Current Guidance | |||
| Revenue | $6.125B-$6.325B | Unchanged | ||
| FX translation headwind | ~$200M | Unchanged, but with potential upside at current rates | ||
| Adjusted gross margin | 60.0%-61.0% | Unchanged | ||
| SG&A | Mid 20% range | Unchanged | ||
| R&D | Upper single-digit | Unchanged | ||
| IPR&D* | - | $6 million | ||
| Adjusted EBITDA margin (Non-GAAP) | 31.0%-32.0% | Unchanged | ||
| Interest | ~$510M | Unchanged | ||
| Depreciation | ~$135M | Unchanged | ||
| Effective non-GAAP tax rate | 22.5%-24.5% | Unchanged | ||
| Fully diluted weighted average shares outstanding | ~263M | Unchanged |
*The company does not provide guidance for forward-looking IPR&D
and milestone expense. The $6 million of IPR&D expense in current guidance reflects IPR&D expense recorded through March 31,
Organon will host a conference call at 8:30 a.m. Eastern Time
today to discuss its first quarter 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 primary
mission to help improve the health of women throughout their lives. Organon's diverse portfolio offers over 70 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 markets.
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 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,