展示99.1

第3四半期の結果を報告します 2024年9月30日までに終了

2024年10月31日、ニュージャージー州ジャージーシティ‐オーガノン（nyse:OGN）は、2024年9月30日に終了した第3四半期の業績を発表しました。

2024年には、弊社の営業実績は非常に優れています。当社の最大の製品、 Nexplanonは、来年10億ドルの売上高を提供する位置にあり、その他の注目すべき成長要因を追加しました エムガリティ 、そして最近では VTAMAと述べました、ケビン・アリ、Organonの最高経営責任者。「さらに、運用コストに非常に厳格であり、調整後のEBITDA成長を推進し、2024年のフルイヤーにおける一時費用を除いた10億ドルのフリーキャッシュフロー達成をサポートしています。」

2024年第3四半期の売上高

合計値は、四捨五入により合致しない場合があり、割合は丸められていない金額を使用して計算されます。

（1）その他には、第三者への製造販売が含まれます。

2024年第3四半期の売上高は総額15.82億ドルで、報告額ベースでは前年比4％増、為替の影響を除くと5％増となりました（FX除く）。

女性の健康関連収入は、報告通り5％、FX取引後は6％増加しました 2024年の第3四半期と2023年の第3四半期との比較は、主に為替差額が11％増加したことによるものです ネクスプラノン® (エトノゲストレルインプラント)。ネクスプラノンの 好調な業績は主に理由でした 米国における需要の増加、有利な価格と割引率、および国際市場での需要の増加、一部には ラテンアメリカでの入札のタイミングによって相殺されます。同社の不妊治療ポートフォリオは、為替市場での需要の増加の結果として、FXを除いて14％増加しました 米国、そして程度は低いですが、さまざまな国際市場に進出していますが、不利な割引率によって一部相殺されています アメリカ合衆国。

NuvaRing®（エトノゲストレル/エチニルエストラジオール膣リング）は、期間中のジェネリック競争の継続的な影響により、fxを除く35％減少しました。 NuvaRing® (etonogestrel / ethinyl estradiol vaginal ring)、避妊リング製品であるNuvaRingは、米国における持続的なジェネリック競争と増加した政府割引率の否定的な影響により、期間中に45%のFXを下落しました。

バイオシミラーの売上高は、第3四半期において報告ベースで16％増加しました。 17% 2024年第3四半期におけるfx調整を除くと、第3四半期と比較して伸びました。 2023主に、アメリカでの2023年7月のローンチ以来、Hadlima（アダリムマブ-bwwd）の採用率が上昇したためです。 Hadlima®（アダリムマブ-bwwd）の売上は Renflexis®(infliximab-abda)

サードクォーターのfxを除いた売上は、主にアメリカとカナダの需要の持続的な成長によるもので、アメリカの不利なディスカウント率に一部相殺されました。 Ontruzant®（トラスツズマブ- dttb）は、ブラジルの入札のタイミングとアメリカとヨーロッパでの需要減少により、fxを除いて減少しました。 49% ex-FXの期間中にOntruzant®はブラジルでの入札のタイミングとアメリカとヨーロッパでの需要減少により、fxを除いて減少しました。

既存ブランドの売上高が伸びました 2% 報告によると 3% fxを除く2024年第三四半期の結果。最近のライセンス取得からの貢献 エムガリティ® （galcanezumab-gnlm）の、中国での成長と注射ステロイドの回復が、第三四半期の9%の出来高成長の主な要因でした。これは日本での不利な価格設定を上回りました。 ⁽¹⁾会社は、2024年全体でのEstablished Brandsフランチャイズの売上高成長が、fxを除くベースでほぼ横ばいの見通しです。 日本での不利な価格設定です。 会社は、Established Brandsフランチャイズの売上高成長が、2024年のフルイヤーでfxを除く基準でほぼ横ばいと予想しています。

(1) EmgalityはEli Lilly and Companyの登録商標です（ライセンス付き）。 is a Eli Lilly and Companyの名前でアメリカ合衆国に登録された商標です（ライセンスのもとで使用されています）。

2024年第3四半期の収益性

粗利率は2024年第3四半期には報告された値が58.3%で、調整後の非GAAPベースでは61.7%でした。これに対して、2023年第3四半期には報告された値が59.7%で、調整後の非GAAPベースでは62.6%でした。 調整後の粗利率が低下したのは、不利な製品ミックスと価格に関連していました。

2024年第3四半期の当期純利益は3億5900万ドルで、1株希薄化後当たり1.38ドルで、2023年第3四半期の5億8000万ドル、または希薄化後1株当たり0.23ドルと比較した。調整後の当期純利益は非GAAPで、2億2600万ドル、または希薄化後1株当たり0.87ドルで、2023年の2億2300万ドル、または希薄化後1株当たり0.87ドルと比較した。GAAPの当期純利益は、会社のスイスのエンティティの税資産に対する2億1000万ドルの評価引当金の解除によって恩恵を受けました。

2024年第3四半期のNon-GAAP調整後のEBITDA利益率は29.0%で、2023年第3四半期の29.4%に比べて主に、2024年第3四半期に$5100万のIPR&D費用が発生したため、前年同期と比較してそうした費用がないことが主な要因です。また、売上総利益の一部として、今年度のSelling、一般管理、研究開発費用は、企業のコスト削減努力の一環として、臨床支出の減少や企業再編イニシアチブに関連する人員整理および企業のERPシステムの導入に伴うコストの低下が原因で、前年同期比5%減少しました。

Capital Allocation

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.

Full Year Guidance

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.

*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.

Webcast Information

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:

https://registrations.events/direct/Q4I58511172

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.

About Organon

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 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, including relevant definitions and reconciliations of non-GAAP financial measures contained herein to the most directly comparable GAAP measures.

In addition, the company’s full-year 2024 guidance measures (other than revenue) are provided on a non-GAAP basis because the company is unable to reasonably predict certain items contained in the GAAP measures. Such items include, but are not limited to, acquisition related expenses, restructuring and related expenses, stock-based compensation, the ultimate outcome of legal proceedings, unusual gains and losses, the occurrence of matters creating GAAP tax impacts and other items not reflective of the company's ongoing operations.

The company’s management uses the non-GAAP financial measures described above to evaluate the company’s performance and to guide operational and financial decision making. Further, the company’s management believes that these non-GAAP financial measures, which exclude certain items, help to enhance its ability to meaningfully communicate its underlying business performance, financial condition and results of operations.

Cautionary Note Regarding Forward-Looking Statements

Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about management’s expectations about Organon’s future financial performance and prospects, including full-year 2024 guidance estimates and predictions regarding other financial information and metrics, and franchise and product performance and strategy expectations for future periods. Forward-looking statements may be identified by words such as “will,” “pursuing,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include, but are not limited to, pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; an inability to fully execute on our product development and commercialization plans in the United States, Europe, and elsewhere internationally; an inability to adapt to the industry-wide trend toward highly discounted channels; difficulties implementing or executing on Organon’s acquisition strategy, difficulties integrating such acquisitions (including its recent acquisition of Dermavant Sciences Ltd.) or any other failure to recognize the benefits of such acquisitions; changes in tax laws or other tax guidance which could adversely affect our cash tax liability, effective tax rates, and results of operations and lead to greater audit scrutiny; expanded brand and class competition in the markets in which the company operates; global tensions, which may result in disruptions in the broader global economic environment; governmental initiatives that adversely impact our marketing activities, particularly in China; volatility in our stock price; political and social pressures, or regulatory developments, that adversely impact demand for, availability of, or patient access to contraception or fertility products; recent Supreme Court decisions and other developments impacting regulatory agencies and their rule making, including related financial market reactions, tax planning and international trade practices; difficulties with performance of third parties we rely on for our business growth; the failure of any supplier to provide substances, materials, or services as agreed; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as our products lose patent protection; any failure by us to obtain an additional period of market exclusivity in the United States for Nexplanon subsequent to the expiration of certain current patents in 2027; the impact of the 2024 United States presidential election and any resulting public policy changes affecting women and their health care decisions, including changes in financial outcomes resulting from candidate positions on healthcare topics and the possible impact on related laws, regulations and policies following the election; the impact of higher selling and promotional costs; and the impact of cyberattacks or other events that may affect Organon’s information technology systems or those of third parties.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the Securities and Exchange Commission ("SEC"), including the company’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov).

TABLE 1

Organon & Co.

Condensed Consolidated Statement of Income

(Unaudited, $ in millions except shares in thousands and per share amounts)

TABLE 2

Organon & Co.

Sales by top products

(Unaudited, $ in millions)

Totals may not foot due to rounding. Trademarks appearing above in italics are trademarks of, or are used under license by, the Organon group of companies.

(1) Sales of the authorized generic versions of NuvaRing, Zetia and Nasonex were previously included in other and have been reclassified to their respective brand name product.

(2) Includes sales of products not listed separately.

(3) Includes manufacturing sales to third parties.

TABLE 3

Organon & Co.

Sales by geographic area 

(Unaudited, $ in millions)

(1) Primarily reflects manufacturing sales to third parties.

TABLE 4

Organon & Co.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics

(Unaudited, $ in millions)

(1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5.

(2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to Table 5.

(1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5.

(1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5.

TABLE 4

(1) For the three months ended September 30, 2024 and 2023, the GAAP income tax rates were (73.7)% and 27.0%, respectively, the non-GAAP income tax rates were 24.7% and 20.8%, respectively. For the nine months ended September 30, 2024 and 2023, the GAAP income tax rates were (11.3)% and 16.1%, respectively, the non-GAAP income tax rates were 19.3% and 17.3%, respectively. These adjustments represent the estimated tax impacts on the reconciling items by applying the statutory rate and applicable law of the originating territory of the non-GAAP adjustments.

TABLE 5

Organon & Co.

Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA

(Unaudited, $ in millions)

(1) Excludes accelerated depreciation included in one-time costs.

(2) Spin-related costs reflect certain costs incurred in connection with activities taken to separate Organon from Merck & Co., Inc., Rahway, NJ, US. These costs include, but are not limited to, $7 million and $32 million for the three months ended September 30, 2024 and 2023, respectively, and $47 million and $100 million for the nine months ended September 30, 2024 and 2023, respectively, for information technology infrastructure, primarily related to the implementation of a stand-alone enterprise resource planning system and redundant software licensing costs, as well as $6 million for the three months ended September 30, 2023 and $20 million and $20 million for the nine months ended September 30, 2024 and 2023, respectively, associated with temporary transition service agreements with Merck & Co., Inc., Rahway, NJ, US.

(3) Manufacturing network related costs, including exiting of temporary manufacturing and supply agreements with Merck & Co., Inc., Rahway, NJ, US, reflect accelerated depreciation, exit premiums, technology transfer costs, stability and qualification batch costs, and third-party contractor costs.

(4) Other costs for the three and nine months ended September 30, 2024 and 2023, respectively, include $4 million related to transaction costs associated with the Dermavant transaction incurred in 2024 and $80 million related to the Microspherix legal matter incurred in 2023.

As the costs described in (1) through (4) above are directly related to the separation of Organon and therefore arise from a one-time event outside of the ordinary course of the company’s operations, the adjustment of these items provides meaningful, supplemental, information that the company believes will enhance an investor's understanding of the company's ongoing operating performance.