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Organon Reports Results for the Third Quarter Ended September 30, 2024

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Organon (OGN) reported strong Q3 2024 results with revenue of $1.582 billion, up 4% as-reported and 5% at constant currency. The company achieved net income of $359 million and diluted EPS of $1.38. Women's Health revenue grew 5%, Biosimilars increased 16%, and Established Brands rose 2%. The company narrowed its full-year 2024 revenue guidance to $6.375-$6.425 billion and revised Adjusted EBITDA margin to 30.0-31.0%. Nexplanon showed strong performance with 11% growth, positioning it to deliver $1 billion in revenue next year. The Board declared a quarterly dividend of $0.28 per share.

Organon (OGN) ha riportato risultati solidi per il terzo trimestre del 2024, con ricavi di 1.582 miliardi di dollari, in aumento del 4% rispetto al valore riportato e del 5% a valuta costante. L'azienda ha ottenuto un utile netto di 359 milioni di dollari e un utile per azione diluito di $1.38. I ricavi della Salute Femminile sono cresciuti del 5%, i Biosimilari sono aumentati del 16% e i Brand Consolidati sono saliti del 2%. L'azienda ha ristretto le previsioni di fatturato per l'intero anno 2024 a un intervallo di 6.375-6.425 miliardi di dollari e ha rivisto il margine EBITDA aggiustato al 30.0-31.0%. Nexplanon ha mostrato una forte performance con una crescita dell'11%, posizionandosi per generare 1 miliardo di dollari di ricavi l'anno prossimo. Il Consiglio ha dichiarato un dividendo trimestrale di 0.28 dollari per azione.

Organon (OGN) informó resultados sólidos para el tercer trimestre de 2024, con ingresos de 1.582 millones de dólares, un aumento del 4% según lo reportado y del 5% a moneda constante. La compañía logró un ingreso neto de 359 millones de dólares y una ganancia por acción diluida de $1.38. Los ingresos de Salud de la Mujer crecieron un 5%, los Biosimilares aumentaron un 16% y las Marcas Establecidas subieron un 2%. La empresa ajustó su guía de ingresos para todo el año 2024 a un rango de 6.375-6.425 millones de dólares y revisó el margen de EBITDA ajustado al 30.0-31.0%. Nexplanon mostró un sólido desempeño con un crecimiento del 11%, posicionándose para generar 1.000 millones de dólares en ingresos el próximo año. La Junta declaró un dividendo trimestral de 0.28 dólares por acción.

오르가논 (OGN)은 2024년 3분기 실적을 발표하며 15억 8200만 달러의 매출을 기록하였고, 이는 보고 기준으로 4% 증가했으며, 일정 환율 기준으로는 5% 증가했다고 밝혔습니다. 이 회사는 3억 5900만 달러의 순이익과 희석 주당순이익(EPS) 1.38달러를 달성했습니다. 여성 건강 부문 매출은 5% 증가하였고, 바이오시밀러는 16% 증가했으며, 기존 브랜드는 2% 상승했습니다. 올해 2024년 전체 매출 전망을 63억 7500만 달러에서 64억 2500만 달러로 조정하였고, 조정된 EBITDA 마진을 30.0-31.0%로 수정했습니다. 넥스플라논은 11% 성장하며 내년 매출 10억 달러 달성을 위한 좋은 성과를 보였습니다. 이사회는 주당 0.28달러의 분기 배당금을 선언했습니다.

Organon (OGN) a rapporté des résultats solides pour le troisième trimestre 2024, avec des revenus de 1,582 milliard de dollars, en hausse de 4 % par rapport au chiffre reporté et de 5 % à taux de change constant. L’entreprise a enregistré un revenu net de 359 millions de dollars et un bénéfice par action dilué de 1,38 dollar. Les revenus de la Santé des Femmes ont augmenté de 5 %, les biosimilaires de 16 %, et les Marques Établies de 2 %. L’entreprise a ajusté ses prévisions de revenus pour l’année 2024 dans une fourchette de 6,375 à 6,425 milliards de dollars et a révisé la marge EBITDA ajustée à 30,0-31,0 %. Nexplanon a montré de solides performances avec une croissance de 11 %, se positionnant pour générer 1 milliard de dollars de revenus l’année prochaine. Le Conseil a déclaré un dividende trimestriel de 0,28 dollar par action.

Organon (OGN) berichtete über starke Ergebnisse für das 3. Quartal 2024 mit einem Umsatz von 1,582 Milliarden Dollar, was einem Anstieg von 4% laut Bericht und 5% bei konstanten Währungsbedingungen entspricht. Das Unternehmen erzielte einen Nettogewinn von 359 Millionen Dollar und einen verwässerten Gewinn pro Aktie von 1,38 Dollar. Der Umsatz im Bereich Frauengesundheit wuchs um 5%, Biosimilars stiegen um 16% und etablierte Marken legten um 2% zu. Das Unternehmen hat die Umsatzprognose für das gesamte Jahr 2024 auf 6,375–6,425 Milliarden Dollar gesenkt und die bereinigte EBITDA-Marge auf 30,0–31,0% überarbeitet. Nexplanon zeigte eine starke Leistung mit einem Wachstum von 11% und ist gut positioniert, um im nächsten Jahr 1 Milliarde Dollar Umsatz zu erzielen. Der Vorstand erklärte eine vierteljährliche Dividende von 0,28 Dollar pro Aktie.

Positive
  • Revenue increased 4% to $1.582 billion
  • Net income surged to $359 million from $58 million YoY
  • Women's Health revenue grew 5%, led by Nexplanon's 11% growth
  • Biosimilars revenue increased 16%
  • Fertility portfolio grew 14%
  • Company raised midpoint of full-year revenue guidance by $50 million
Negative
  • Gross margin declined to 58.3% from 59.7% YoY
  • NuvaRing sales declined 45% due to generic competition
  • Ontruzant sales dropped 49%
  • Adjusted EBITDA margin decreased to 29.0% from 29.4%
  • $51 million expense incurred for IPR&D and milestones

Insights

The Q3 2024 results show encouraging momentum with $1.582 billion revenue, up 4% year-over-year. Key highlights include strong performance in Women's Health (up 6% ex-FX) and Biosimilars (up 17% ex-FX). Nexplanon's trajectory towards $1 billion in revenue next year is particularly noteworthy.

The company's profitability metrics reveal mixed signals. While net income surged to $359 million, this was largely due to a one-time tax benefit of $210 million. The adjusted EBITDA margin slightly declined to 29.0%, impacted by a $51 million IPR&D expense. The maintained quarterly dividend of $0.28 per share indicates financial stability despite $8.7 billion in debt.

Management's raised revenue guidance midpoint by $50 million demonstrates confidence in commercial execution, though adjusted EBITDA margin guidance was revised down to 30.0-31.0%.

The company's strategic positioning is strengthening through portfolio diversification. The successful integration of Emgality and VTAMA adds new growth drivers beyond core products. Nexplanon's dominant performance and the 17% growth in Biosimilars, particularly Hadlima's U.S. launch momentum, demonstrate effective market penetration strategies.

The Established Brands segment's 3% ex-FX growth, driven by 9% volume growth, shows resilience despite pricing pressures in Japan. The company's cost containment efforts, including headcount reduction and ERP implementation efficiencies, indicate pragmatic operational management, though continued margin pressure warrants monitoring.

  • Third quarter 2024 revenue of $1.582 billion, up 4% as-reported and up 5% at constant currency
  • Third quarter 2024 diluted earnings per share of $1.38 and non-GAAP Adjusted diluted earnings per share of $0.87; both reported and non-GAAP Adjusted diluted earnings per share include $51 million of expense, or $0.16 per share, for acquired in-process research and development (IPR&D) and milestones
  • Third quarter 2024 net income of $359 million and Adjusted EBITDA (non-GAAP) of $459 million
  • Guidance range for full year 2024 revenue narrowed to $6.375 billion to $6.425 billion, mid-point of the range raised by $50 million; Guidance range for Adjusted EBITDA margin (non-GAAP) revised to 30.0% to 31.0%, inclusive of the $51 million of IPR&D expense incurred in the third quarter

JERSEY CITY, N.J.--(BUSINESS WIRE)-- 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 the United States.

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® (infliximab-abda) 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.

(1) Emgality is a 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

%

 

 

(1)

 

See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures.

(2)

 

Adjusted EBITDA and Adjusted EBITDA margin included $51 million in the third quarter of 2024 related to Acquired IPR&D and milestones. There was no Acquired IPR&D in the third quarter of 2023.

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.

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.

 

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.

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)

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

 

2024

 

 

 

2023

 

 

2024

 

 

 

2023

Revenues

$

1,582

 

 

$

1,519

 

$

4,811

 

 

$

4,665

Cost of sales

 

659

 

 

 

612

 

 

1,992

 

 

 

1,832

Gross Profit

 

923

 

 

 

907

 

 

2,819

 

 

 

2,833

 

 

 

 

 

 

 

 

Selling, general and administrative

 

422

 

 

 

538

 

 

1,290

 

 

 

1,424

Research and development

 

111

 

 

 

137

 

 

339

 

 

 

394

Acquired in-process research and development and milestones

 

51

 

 

 

 

 

81

 

 

 

8

Restructuring costs

 

 

 

 

 

 

23

 

 

 

4

Interest expense

 

126

 

 

 

134

 

 

388

 

 

 

398

Exchange losses

 

6

 

 

 

14

 

 

11

 

 

 

25

Other expense, net

 

 

 

 

4

 

 

9

 

 

 

11

Income before income taxes

 

207

 

 

 

80

 

 

678

 

 

 

569

Tax (benefit) expense

 

(152

)

 

 

22

 

 

(77

)

 

 

92

Net income

$

359

 

 

$

58

 

$

755

 

 

$

477

 

 

 

 

 

 

 

 

Earnings per share:

 

 

 

 

 

 

 

Basic

$

1.39

 

 

$

0.23

 

$

2.94

 

 

$

1.87

Diluted

$

1.38

 

 

$

0.23

 

$

2.92

 

 

$

1.86

 

 

 

 

 

 

 

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

Basic

 

257,498

 

 

 

255,588

 

 

256,830

 

 

 

255,112

Diluted

 

259,757

 

 

 

256,349

 

 

258,908

 

 

 

256,162

TABLE 2
 

Organon & Co.

Sales by top products

(Unaudited, $ in millions)

 

 

 

 

 

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

 

2024

 

2023

 

2024

 

2023

 

 

U.S.

 

Int’l

 

Total

 

U.S.

 

Int’l

 

Total

 

U.S.

 

Int’l

 

Total

 

U.S.

 

Int’l

 

Total

Women’s Health

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nexplanon/Implanon NXT

$

172

 

$

70

 

$

243

 

$

146

 

$

74

 

$

220

 

$

497

 

 

$

207

 

$

704

 

$

418

 

 

$

181

 

$

599

Follistim AQ

 

26

 

 

37

 

 

63

 

 

22

 

 

32

 

 

54

 

 

59

 

 

 

113

 

 

171

 

 

74

 

 

 

105

 

 

179

NuvaRing (1)

 

7

 

 

17

 

 

23

 

 

23

 

 

20

 

 

43

 

 

33

 

 

 

57

 

 

90

 

 

70

 

 

 

67

 

 

137

Ganirelix Acetate Injection

 

5

 

 

20

 

 

26

 

 

4

 

 

21

 

 

25

 

 

16

 

 

 

65

 

 

82

 

 

15

 

 

 

74

 

 

88

Marvelon/Mercilon

 

 

 

29

 

 

29

 

 

 

 

30

 

 

30

 

 

 

 

 

103

 

 

103

 

 

 

 

 

97

 

 

97

Jada

 

15

 

 

 

 

16

 

 

12

 

 

 

 

13

 

 

42

 

 

 

1

 

 

43

 

 

30

 

 

 

 

 

31

Other Women’s Health (1) (2)

 

14

 

 

28

 

 

40

 

 

11

 

 

22

 

 

33

 

 

41

 

 

 

78

 

 

119

 

 

32

 

 

 

74

 

 

106

Biosimilars

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Renflexis

 

56

 

 

16

 

 

72

 

 

57

 

 

12

 

 

69

 

 

167

 

 

 

43

 

 

210

 

 

172

 

 

 

29

 

 

201

Ontruzant

 

5

 

 

15

 

 

20

 

 

11

 

 

28

 

 

40

 

 

23

 

 

 

84

 

 

107

 

 

36

 

 

 

57

 

 

93

Brenzys

 

 

 

27

 

 

27

 

 

 

 

13

 

 

13

 

 

 

 

 

63

 

 

63

 

 

 

 

 

45

 

 

45

Aybintio

 

 

 

7

 

 

7

 

 

 

 

12

 

 

12

 

 

 

 

 

22

 

 

22

 

 

 

 

 

34

 

 

34

Hadlima

 

29

 

 

11

 

 

40

 

 

2

 

 

6

 

 

8

 

 

71

 

 

 

27

 

 

98

 

 

2

 

 

 

18

 

 

20

Established Brands

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cardiovascular

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zetia (1)

 

2

 

 

80

 

 

81

 

 

2

 

 

68

 

 

69

 

 

5

 

 

 

235

 

 

240

 

 

5

 

 

 

248

 

 

253

Vytorin

 

1

 

 

25

 

 

26

 

 

2

 

 

31

 

 

33

 

 

4

 

 

 

78

 

 

82

 

 

5

 

 

 

95

 

 

100

Atozet

 

 

 

125

 

 

125

 

 

 

 

126

 

 

126

 

 

 

 

 

396

 

 

396

 

 

 

 

 

397

 

 

397

Rosuzet

 

 

 

11

 

 

11

 

 

 

 

17

 

 

17

 

 

 

 

 

36

 

 

36

 

 

 

 

 

52

 

 

52

Cozaar/Hyzaar

 

2

 

 

57

 

 

59

 

 

3

 

 

65

 

 

68

 

 

7

 

 

 

179

 

 

186

 

 

8

 

 

 

217

 

 

225

Other Cardiovascular (1) (2)

 

 

 

27

 

 

29

 

 

1

 

 

39

 

 

41

 

 

2

 

 

 

97

 

 

99

 

 

2

 

 

 

110

 

 

112

Respiratory

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Singulair

 

2

 

 

83

 

 

85

 

 

3

 

 

88

 

 

91

 

 

7

 

 

 

268

 

 

275

 

 

8

 

 

 

282

 

 

290

Nasonex (1)

 

 

 

63

 

 

63

 

 

 

 

60

 

 

60

 

 

 

 

 

200

 

 

200

 

 

 

 

 

197

 

 

197

Dulera

 

38

 

 

10

 

 

48

 

 

40

 

 

9

 

 

49

 

 

120

 

 

 

31

 

 

151

 

 

116

 

 

 

28

 

 

144

Clarinex

 

1

 

 

26

 

 

27

 

 

2

 

 

26

 

 

28

 

 

2

 

 

 

97

 

 

100

 

 

4

 

 

 

103

 

 

107

Other Respiratory (1) (2)

 

11

 

 

3

 

 

14

 

 

17

 

 

3

 

 

20

 

 

26

 

 

 

10

 

 

35

 

 

42

 

 

 

10

 

 

52

Non-Opioid Pain, Bone and Dermatology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Arcoxia

 

 

 

69

 

 

69

 

 

 

 

64

 

 

64

 

 

 

 

 

211

 

 

211

 

 

 

 

 

207

 

 

207

Fosamax

 

1

 

 

37

 

 

38

 

 

1

 

 

40

 

 

41

 

 

3

 

 

 

109

 

 

112

 

 

2

 

 

 

121

 

 

123

Diprospan

 

 

 

37

 

 

37

 

 

 

 

31

 

 

31

 

 

 

 

 

102

 

 

102

 

 

 

 

 

58

 

 

58

Other Non-Opioid Pain, Bone and Dermatology (2)

 

5

 

 

69

 

 

74

 

 

4

 

 

70

 

 

74

 

 

15

 

 

 

212

 

 

227

 

 

11

 

 

 

196

 

 

207

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Emgality/Rayvow

 

 

 

29

 

 

29

 

 

 

 

 

 

 

 

 

 

 

69

 

 

69

 

 

 

 

 

 

 

Proscar

 

 

 

23

 

 

23

 

 

 

 

25

 

 

25

 

 

1

 

 

 

72

 

 

73

 

 

1

 

 

 

76

 

 

77

Propecia

 

2

 

 

27

 

 

28

 

 

2

 

 

21

 

 

22

 

 

5

 

 

 

74

 

 

79

 

 

5

 

 

 

86

 

 

92

Other (2)

 

3

 

 

80

 

 

84

 

 

5

 

 

72

 

 

76

 

 

12

 

 

 

229

 

 

241

 

 

10

 

 

 

231

 

 

240

Other (3)

 

1

 

 

26

 

 

26

 

 

 

 

24

 

 

24

 

 

(2

)

 

 

87

 

 

85

 

 

(1

)

 

 

103

 

 

102

Revenues

$

398

 

$

1,184

 

$

1,582

 

$

370

 

$

1,149

 

$

1,519

 

$

1,156

 

 

$

3,655

 

$

4,811

 

$

1,067

 

 

$

3,598

 

$

4,665

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)

 

 

 

 

 

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

 

2024

 

2023

 

2024

 

2023

Europe and Canada

$

436

 

$

392

 

$

1,343

 

$

1,259

United States

 

398

 

 

370

 

 

1,156

 

 

1,067

Asia Pacific and Japan

 

260

 

 

284

 

 

806

 

 

869

China

 

212

 

 

202

 

 

634

 

 

661

Latin America, Middle East, Russia, and Africa

 

243

 

 

239

 

 

768

 

 

687

Other (1)

 

33

 

 

32

 

 

104

 

 

122

Revenues

$

1,582

 

$

1,519

 

$

4,811

 

$

4,665

(1) Primarily reflects manufacturing sales to third parties.

TABLE 4

Organon & Co.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics

(Unaudited, $ in millions)

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

GAAP Gross Profit

$

923

 

 

$

907

 

 

$

2,819

 

 

$

2,833

 

Adjusted for:

 

 

 

 

 

 

 

Spin-related costs (1)

 

 

 

 

10

 

 

 

6

 

 

 

30

 

Manufacturing network costs (2)

 

14

 

 

 

 

 

 

39

 

 

 

 

Stock-based compensation

 

4

 

 

 

5

 

 

 

13

 

 

 

13

 

Amortization

 

35

 

 

 

29

 

 

 

102

 

 

 

88

 

Other

 

 

 

 

 

 

 

 

 

 

2

 

Adjusted Non-GAAP Gross Profit

$

976

 

 

$

951

 

 

$

2,979

 

 

$

2,966

 

 

 

 

 

 

 

 

 

(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.

 

 

 

 

 

 

 

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

GAAP Gross Margin

 

58.3

%

 

 

59.7

%

 

 

58.6

%

 

 

60.7

%

Total impact of Non-GAAP adjustments

 

3.4

%

 

 

2.9

%

 

 

3.3

%

 

 

2.9

%

Adjusted Non-GAAP Gross Margin

 

61.7

%

 

 

62.6

%

 

 

61.9

%

 

 

63.6

%

 

 

 

 

 

 

 

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

GAAP Selling, general and administrative expenses

$

422

 

 

$

538

 

 

$

1,290

 

 

$

1,424

 

Adjusted for:

 

 

 

 

 

 

 

Spin-related costs (1)

 

(10

)

 

 

(41

)

 

 

(79

)

 

 

(131

)

Stock-based compensation

 

(17

)

 

 

(18

)

 

 

(53

)

 

 

(50

)

Other

 

(4

)

 

 

(87

)

 

 

(4

)

 

 

(88

)

Adjusted Non-GAAP Selling, general and administrative expenses

$

391

 

 

$

392

 

 

$

1,154

 

 

$

1,155

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

GAAP Research and development expenses

$

111

 

 

$

137

 

 

$

339

 

 

$

394

 

Adjusted for:

 

 

 

 

 

 

 

Spin-related costs (1)

 

(2

)

 

 

(4

)

 

 

(5

)

 

 

(10

)

Stock-based compensation

 

(4

)

 

 

(4

)

 

 

(13

)

 

 

(11

)

Adjusted Non-GAAP Research and development expenses

$

105

 

 

$

129

 

 

$

321

 

 

$

373

 

 

 

 

 

 

 

 

 

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

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

GAAP Reported Net Income

$

359

 

 

$

58

 

 

$

755

 

 

$

477

 

Adjusted for:

 

 

 

 

 

 

 

Cost of sales adjustments

 

53

 

 

 

44

 

 

 

160

 

 

 

133

 

Selling, general and administrative adjustments

 

31

 

 

 

146

 

 

 

136

 

 

 

269

 

Research and development adjustments

 

6

 

 

 

8

 

 

 

18

 

 

 

21

 

Restructuring

 

 

 

 

 

 

 

23

 

 

 

4

 

Other expense, net

 

4

 

 

 

3

 

 

 

14

 

 

 

13

 

Tax impact on adjustments above(1)

 

(227

)

 

 

(36

)

 

 

(276

)

 

 

(82

)

Non-GAAP Adjusted Net Income

$

226

 

 

$

223

 

 

$

830

 

 

$

835

 

 

 

 

 

 

 

 

 

(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.

 

 

 

 

 

 

 

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

GAAP Diluted Earnings per Share

$

1.38

 

 

$

0.23

 

 

$

2.92

 

 

$

1.86

 

Total impact of Non-GAAP adjustments

$

(0.51

)

 

$

0.64

 

 

$

0.29

 

 

$

1.40

 

Non-GAAP Diluted Earnings per Share

$

0.87

 

 

$

0.87

 

 

$

3.21

 

 

$

3.26

 

TABLE 5

 

Organon & Co.

Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA

(Unaudited, $ in millions)

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

Net income

$

359

 

 

$

58

 

 

$

755

 

 

$

477

 

Depreciation (1)

 

32

 

 

 

32

 

 

 

93

 

 

 

88

 

Amortization

 

35

 

 

 

29

 

 

 

102

 

 

 

88

 

Interest expense

 

126

 

 

 

134

 

 

 

388

 

 

 

398

 

Tax (benefit) expense

 

(152

)

 

 

22

 

 

 

(77

)

 

 

92

 

EBITDA

$

400

 

 

$

275

 

 

$

1,261

 

 

$

1,143

 

Restructuring costs

 

 

 

 

 

 

 

23

 

 

 

4

 

Spin-related costs (2)

 

16

 

 

 

58

 

 

 

104

 

 

 

184

 

Manufacturing network related (3)

 

14

 

 

 

 

 

 

39

 

 

 

 

Other costs (4)

 

4

 

 

 

87

 

 

 

4

 

 

 

90

 

Stock-based compensation

 

25

 

 

 

27

 

 

 

79

 

 

 

74

 

Adjusted EBITDA (Non-GAAP)

$

459

 

 

$

447

 

 

$

1,510

 

 

$

1,495

 

Adjusted EBITDA margin (Non-GAAP)

 

29.0

%

 

 

29.4

%

 

 

31.4

%

 

 

32.0

%

 

 

 

 

 

 

 

 

(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.

 

Media Contacts:

Karissa Peer

(614) 314-8094

Kate Vossen

(732) 675-8448

Investor Contacts:

Jennifer Halchak

(201) 275-2711

Renee McKnight

(551) 204-6129

Source: Organon & Co.

FAQ

What was Organon's (OGN) revenue in Q3 2024?

Organon reported Q3 2024 revenue of $1.582 billion, representing a 4% increase as-reported and 5% at constant currency compared to Q3 2023.

How much did Organon's (OGN) Women's Health segment grow in Q3 2024?

Organon's Women's Health revenue increased 5% as-reported and 6% excluding foreign exchange impact in Q3 2024, primarily driven by 11% growth in Nexplanon.

What is Organon's (OGN) full-year 2024 revenue guidance?

Organon narrowed its full-year 2024 revenue guidance to $6.375-$6.425 billion, with the mid-point raised by $50 million.

What dividend did Organon (OGN) declare for Q3 2024?

Organon's Board of Directors declared a quarterly dividend of $0.28 per share, payable on December 12, 2024, to stockholders of record as of November 12, 2024.

Organon & Co.

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