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| Share Name | Share Symbol | Market | Type |
|---|---|---|---|
| Organon and Co | NYSE:OGN | NYSE | Common Stock |
| Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|
| -0.02 | -0.13% | 15.29 | 15.33 | 14.855 | 15.28 | 2,801,931 | 01:00:00 |
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report
(Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of | (Commission File Number) | (I.R.S. Employer Identification No.) | ||
| incorporation) | ||||
| (Address and principal executive | (Zip Code) | |||
| offices) |
| Registrant’s telephone number, including area code: ( |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) |
Name of
each exchange on which registered | ||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 2.02 | Results of Operations and Financial Condition. |
On August 6, 2024, Organon & Co. (the “Company”) issued a press release (the “Earnings Release”) regarding its results for the quarter ended June 30, 2024. The Earnings Release is included as Exhibit 99.1 to this report.
The information contained in this Item 2.02, including Exhibit 99.1 attached hereto, is considered to be “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that Section. The information in this Current Report shall not be incorporated by reference into any filing or other document pursuant to the Securities Act of 1933, as amended (the “Securities Act”) or the Exchange Act, except as shall be expressly set forth by specific reference in such filing or document. The release contains forward-looking statements regarding the Company and includes a cautionary statement identifying important factors that could cause actual results to differ materially from those anticipated.
| Item 7.01 | Regulation FD Disclosure. |
In connection with the conference call announced in the Earnings Release, on August 6, 2024, the Company made available the Company Information Presentation relating to its financial results for the quarter ended June 30, 2024. The Company Information Presentation may be accessed within the investor relations section of the Company’s website, https://www.organon.com. A copy of the Company Information Presentation is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
The information in this Item 7.01, including Exhibit 99.2 attached hereto, is considered to be “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to liability under that Section. The information in this Current Report shall not be incorporated by reference into any filing or other document pursuant to the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing or document. The Company Information Presentation contains forward-looking statements regarding the Company and includes a cautionary statement identifying important factors that could cause actual results to differ materially from those anticipated.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit No. | Description | |
| 99.1 | Press Release, dated August 6, 2024, relating to results of operations and financial condition. | |
| 99.2 | Company Information Presentation. | |
| 104 | The cover page of this Current Report on Form 8-K, formatted in Inline XBRL. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
| Organon & Co. | |||
| By: | /s/ Matthew Walsh | ||
| Name: | Matthew Walsh | ||
| Title: | Chief Financial Officer | ||
Dated: August 6, 2024
Exhibit 99.1
| Media Contacts: | Karissa Peer | Investor Contacts: | Jennifer Halchak |
| (614) 314-8094 | (201) 275-2711 | ||
| Kate Vossen | Renee McKnight | ||
| (732) 675-8448 | (551) 204-6129 |
Organon Reports Results for the Second Quarter Ended June 30, 2024
| · | Second quarter 2024 revenue of $1.607 billion, flat year-over-year on an as-reported basis and up 2% at constant currency |
| · | Second quarter 2024 diluted earnings per share of $0.75 and non-GAAP Adjusted diluted earnings per share of $1.12; both reported and non-GAAP Adjusted diluted earnings per share include $15 million of expense, or $0.05 per share, for acquired in-process research and development (IPR&D) and milestones |
| · | Second quarter 2024 net income of $195 million and Adjusted EBITDA (non-GAAP) of $513 million |
| · | Guidance range for full year 2024 revenue narrowed to $6.250 billion to $6.450 billion, mid-point of the range, affirmed; Guidance range for Adjusted EBITDA margin (non-GAAP) affirmed at 31.0%-33.0% |
Jersey City, N.J., August 6, 2024 – Organon (NYSE: OGN) today announced its results for the second quarter ended June 30, 2024.
1
"We are very pleased with our year to date results," said Kevin Ali, Organon's Chief Executive Officer. "We are tracking well to our 2024 objectives of delivering revenue growth at constant currency, driving year-over-year EBITDA improvement and generating approximately $1 billion of free cash flow before spin-related, one-time costs."
Second Quarter 2024 Revenue
| in $ millions | Q2 2024 | Q2 2023 | VPY | VPY ex-FX | ||||||||||||
| Women’s Health | $ | 449 | $ | 438 | 3 | % | 3 | % | ||||||||
| Biosimilars | 164 | 135 | 22 | % | 22 | % | ||||||||||
| Established Brands | 963 | 995 | (3 | )% | (1 | )% | ||||||||||
| Other (1) | 31 | 40 | (20 | )% | (20 | )% | ||||||||||
| Revenues | $ | 1,607 | $ | 1,608 | — | % | 2 | % | ||||||||
Totals may not foot due to rounding and percentages are computed using unrounded amounts.
(1) Other includes manufacturing sales to third parties.
For the second quarter of 2024, total revenue was $1.607 billion, flat year-over-year on an as-reported basis and an increase of 2% excluding the impact of foreign currency (ex-FX).
Women’s Health revenue increased 3% on both an as-reported basis and ex-FX basis in the second quarter of 2024 compared with the second quarter of 2023 primarily driven by 13% ex-FX growth in Nexplanon® (etonogestrel implant). Nexplanon's strong performance was primarily due to favorable discount rates in the United States, an increase in demand in the company's institutional business in Africa, and increased demand in certain international markets. Sales of MarvelonTM (desogestrel and ethinyl estradiol pill) and MercilonTM (desogestrel and ethinyl estradiol pill), combined oral hormonal daily contraceptive pills also grew strongly, up 42% ex-FX compared to prior year as a result of increased demand in various markets outside the U.S.
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 35% ex-FX during the period due to ongoing generic competition. The company's fertility portfolio was down 8% ex-FX in the second quarter, primarily due to a difficult comparison to a stronger prior period for the China fertility business, which benefited from volume recovery post-COVID 19 lockdowns coupled with a buy-out of Follistim AQ® (follitropin beta injection) in the U.S. following a significant buy-in during the fourth quarter of 2023 related to the exit of a temporary spin-off related commercial arrangement and the onboarding of a large customer.
2
Biosimilars revenue grew 22% on both an as-reported basis and ex-FX basis in the second quarter of 2024, compared with the second quarter of 2023, primarily due to the uptake of Hadlima® (adalimumab-bwwd) since its July 2023 launch in the U.S. Ontruzant® (trastuzumab-dttb) grew 46% ex-FX during the quarter driven by increased demand associated with a government tender in Brazil partially offset by the negative impact of unfavorable discount rates in the U.S and lower demand in Europe. Performance was partially offset by a 2% ex-FX decline in Renflexis® (infliximab-abda) which was driven primarily by an increase in discount rates in the U.S.
Established Brands revenue was down 3% on an as-reported basis and declined 1% ex-FX in the second 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 partially offset the impacts of Volume Based Procurement initiatives in China, expected mandatory pricing revisions in Japan and phasing of shipments for certain products in select markets related to the implementation of the company's enterprise resource planning system. 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).
3
Second Quarter 2024 Profitability
| in $ millions, except per share amounts | Q2 2024 | Q2 2023 | VPY | |||||||||
| Revenues | $ | 1,607 | $ | 1,608 | — | % | ||||||
| Cost of sales | 668 | 640 | 4 | % | ||||||||
| Gross profit | 939 | 968 | (3 | )% | ||||||||
| Non-GAAP Adjusted gross profit (1) | 996 | 1,012 | (2 | )% | ||||||||
| Net income | 195 | 242 | (19 | )% | ||||||||
| Non-GAAP Adjusted net income (1) | 289 | 336 | (14 | )% | ||||||||
| Diluted Earnings per Share (EPS) | 0.75 | 0.95 | (21 | )% | ||||||||
| Non-GAAP Adjusted diluted EPS (1) | 1.12 | 1.31 | (15 | )% | ||||||||
| Acquired IPR&D and milestones | 15 | — | NM | |||||||||
| Per share impact to diluted EPS from acquired IPR&D and milestones | (0.05 | ) | — | NM | ||||||||
| Adjusted EBITDA (Non-GAAP) (1,2) | 513 | 530 | (3 | )% | ||||||||
| Q2 2024 | Q2 2023 | |||||||||||
| Gross margin | 58.4 | % | 60.2 | % | ||||||||
| Non-GAAP Adjusted gross margin (1) | 62.0 | % | 62.9 | % | ||||||||
| Adjusted EBITDA margin (Non-GAAP) (1, 2) | 31.9 | % | 33.0 | % | ||||||||
| (1) | See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures. |
| (2) | Adjusted EBITDA and Adjusted EBITDA margin included $15 million in the second quarter of 2024 related to Acquired IPR&D and milestones. There was no Acquired IPR&D in the second quarter of 2023. |
Gross margin was 58.4% as-reported and 62.0% on a non-GAAP adjusted basis in the second quarter of 2024 compared with 60.2% as-reported and 62.9% on a non-GAAP adjusted basis in the second 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 second quarter of 2024 was $195 million, or $0.75 per diluted share, compared with $242 million, or $0.95 per diluted share, in the second quarter of 2023. Non-GAAP Adjusted net income was $289 million, or $1.12 per diluted share, compared with $336 million, or $1.31 per diluted share, in 2023.
4
Non-GAAP Adjusted EBITDA margin was 31.9% in the second quarter of 2024 compared with 33.0% in the second quarter of 2023 primarily due to lower non-GAAP Adjusted gross margin. Total non-GAAP operating expenses (selling, general and administrative and research and development) were down 2% year over year.
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 September 12, 2024, to stockholders of record at the close of business on August 16, 2024.
As of June 30, 2024, cash and cash equivalents were $704 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.
5
Full year 2024 financial guidance is presented below on a non-GAAP basis, except revenue.
| Previous
guidance as of May 2, 2024 | Current guidance | |||
| Revenues | $6.2B - $6.5B | $6.25B - $6.45B | ||
| Adjusted gross margin | 61.0% - 63.0% | Unchanged | ||
| SG&A | $1.5B - $1.7B | Unchanged | ||
| R&D | $400M - $500M | $430M - $530M* | ||
| 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 |
*Updated R&D expense guidance includes $30 million of IPR&D and milestone expense incurred year-to-date June 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 second 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/Q4I585119
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.
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About Organon
Organon is an independent global healthcare company with a strategy 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 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.
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.
7
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 "foresees" “expects,” “intends,” “anticipates,” “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.
8
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; 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; uncertainty regarding the U.S. federal budget and debt ceiling, and the impact of a potential U.S. federal government shutdown; 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; 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; difficulties implementing or executing on our acquisition strategy or failure to recognize the benefits of such acquisitions; and the impact of higher selling and promotional costs.
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).
9
TABLE 1
Organon & Co.
Condensed Consolidated Statement of Income
(Unaudited, $ in millions except shares in thousands and per share amounts)
| Three Months
Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues | $ | 1,607 | $ | 1,608 | $ | 3,229 | $ | 3,146 | ||||||||
| Cost of sales | 668 | 640 | 1,333 | 1,220 | ||||||||||||
| Gross Profit | 939 | 968 | 1,896 | 1,926 | ||||||||||||
| Selling, general and administrative | 437 | 451 | 868 | 886 | ||||||||||||
| Research and development | 116 | 128 | 228 | 257 | ||||||||||||
| Acquired in-process research and development and milestones | 15 | — | 30 | 8 | ||||||||||||
| Restructuring costs | — | — | 23 | 4 | ||||||||||||
| Interest expense | 131 | 132 | 262 | 264 | ||||||||||||
| Exchange (gains) losses | (1 | ) | 2 | 5 | 11 | |||||||||||
| Other expense, net | 6 | 1 | 9 | 7 | ||||||||||||
| Income before income taxes | 235 | 254 | 471 | 489 | ||||||||||||
| Taxes on income | 40 | 12 | 75 | 70 | ||||||||||||
| Net income | $ | 195 | $ | 242 | $ | 396 | $ | 419 | ||||||||
| Earnings per share: | ||||||||||||||||
| Basic | $ | 0.76 | $ | 0.95 | $ | 1.54 | $ | 1.64 | ||||||||
| Diluted | $ | 0.75 | $ | 0.95 | $ | 1.53 | $ | 1.64 | ||||||||
| Weighted average shares outstanding: | ||||||||||||||||
| Basic | 257,288 | 255,341 | 256,492 | 254,869 | ||||||||||||
| Diluted | 258,598 | 255,953 | 258,480 | 256,064 | ||||||||||||
TABLE 2
Organon & Co.
Sales by top products
(Unaudited, $ in millions)
| Three Months Ended June 30, | Six Months Ended June 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 | $ | 171 | $ | 70 | $ | 242 | $ | 159 | $ | 56 | $ | 214 | $ | 324 | $ | 137 | $ | 462 | $ | 272 | $ | 107 | $ | 380 | ||||||||||||||||||||||||
| Follistim AQ | 22 | 40 | 62 | 26 | 44 | 70 | 33 | 75 | 108 | 52 | 73 | 125 | ||||||||||||||||||||||||||||||||||||
| NuvaRing (1) | 10 | 19 | 29 | 23 | 23 | 46 | 26 | 41 | 67 | 48 | 47 | 94 | ||||||||||||||||||||||||||||||||||||
| Ganirelix Acetate Injection | 5 | 22 | 27 | 4 | 29 | 34 | 11 | 45 | 56 | 11 | 53 | 63 | ||||||||||||||||||||||||||||||||||||
| Marvelon/Mercilon | — | 41 | 41 | — | 29 | 29 | — | 73 | 73 | — | 67 | 67 | ||||||||||||||||||||||||||||||||||||
| Jada | 14 | — | 14 | 11 | — | 11 | 27 | — | 27 | 18 | — | 18 | ||||||||||||||||||||||||||||||||||||
| Other Women’s Health (1) (2) | 13 | 23 | 34 | 10 | 25 | 35 | 27 | 52 | 79 | 20 | 52 | 73 | ||||||||||||||||||||||||||||||||||||
| Biosimilars | ||||||||||||||||||||||||||||||||||||||||||||||||
| Renflexis | 56 | 13 | 69 | 60 | 11 | 70 | 111 | 27 | 138 | 114 | 18 | 132 | ||||||||||||||||||||||||||||||||||||
| Ontruzant | 10 | 38 | 48 | 12 | 21 | 33 | 18 | 69 | 87 | 25 | 29 | 54 | ||||||||||||||||||||||||||||||||||||
| Brenzys | — | 12 | 12 | — | 13 | 13 | — | 36 | 36 | — | 32 | 32 | ||||||||||||||||||||||||||||||||||||
| Aybintio | — | 7 | 7 | — | 12 | 12 | — | 15 | 15 | — | 22 | 22 | ||||||||||||||||||||||||||||||||||||
| Hadlima | 20 | 8 | 28 | — | 7 | 7 | 42 | 16 | 58 | — | 12 | 12 | ||||||||||||||||||||||||||||||||||||
| Established Brands | ||||||||||||||||||||||||||||||||||||||||||||||||
| Cardiovascular | ||||||||||||||||||||||||||||||||||||||||||||||||
| Zetia (1) | 2 | 73 | 75 | 2 | 94 | 95 | 4 | 155 | 159 | 4 | 180 | 184 | ||||||||||||||||||||||||||||||||||||
| Vytorin | 2 | 26 | 28 | 1 | 37 | 38 | 3 | 52 | 56 | 3 | 65 | 67 | ||||||||||||||||||||||||||||||||||||
| Atozet | — | 140 | 140 | — | 143 | 143 | — | 271 | 271 | — | 271 | 271 | ||||||||||||||||||||||||||||||||||||
| Rosuzet | — | 9 | 9 | — | 17 | 17 | — | 25 | 25 | — | 35 | 35 | ||||||||||||||||||||||||||||||||||||
| Cozaar/Hyzaar | 2 | 58 | 60 | 2 | 69 | 71 | 5 | 122 | 127 | 4 | 152 | 156 | ||||||||||||||||||||||||||||||||||||
| Other Cardiovascular (1) (2) | 1 | 31 | 32 | 1 | 36 | 36 | 1 | 71 | 71 | 1 | 70 | 71 | ||||||||||||||||||||||||||||||||||||
| Respiratory | ||||||||||||||||||||||||||||||||||||||||||||||||
| Singulair | 2 | 90 | 93 | 3 | 77 | 80 | 5 | 186 | 190 | 5 | 194 | 199 | ||||||||||||||||||||||||||||||||||||
| Nasonex (1) | — | 60 | 60 | — | 66 | 66 | — | 137 | 137 | — | 137 | 137 | ||||||||||||||||||||||||||||||||||||
| Dulera | 39 | 8 | 47 | 38 | 10 | 48 | 82 | 21 | 103 | 76 | 18 | 95 | ||||||||||||||||||||||||||||||||||||
| Clarinex | 1 | 35 | 35 | 1 | 38 | 39 | 2 | 71 | 73 | 2 | 77 | 79 | ||||||||||||||||||||||||||||||||||||
| Other Respiratory (1) (2) | 8 | 4 | 13 | 13 | 4 | 17 | 15 | 6 | 22 | 25 | 8 | 33 | ||||||||||||||||||||||||||||||||||||
| Non-Opioid Pain, Bone and Dermatology | ||||||||||||||||||||||||||||||||||||||||||||||||
| Arcoxia | — | 68 | 68 | — | 72 | 72 | — | 143 | 143 | — | 143 | 143 | ||||||||||||||||||||||||||||||||||||
| Fosamax | 1 | 34 | 35 | 1 | 44 | 44 | 3 | 72 | 74 | 1 | 81 | 82 | ||||||||||||||||||||||||||||||||||||
| Diprospan | — | 37 | 37 | — | 12 | 12 | — | 66 | 66 | — | 27 | 27 | ||||||||||||||||||||||||||||||||||||
| Other Non-Opioid Pain, Bone and Dermatology (1) | 5 | 73 | 78 | 2 | 67 | 71 | 9 | 141 | 151 | 7 | 127 | 133 | ||||||||||||||||||||||||||||||||||||
| Other | ||||||||||||||||||||||||||||||||||||||||||||||||
| Emgality/Rayvow | — | 30 | 30 | — | — | — | — | 40 | 40 | — | — | — | ||||||||||||||||||||||||||||||||||||
| Proscar | — | 23 | 23 | — | 24 | 25 | 1 | 49 | 50 | 1 | 51 | 52 | ||||||||||||||||||||||||||||||||||||
| Propecia | 2 | 27 | 28 | 2 | 35 | 36 | 3 | 47 | 51 | 4 | 66 | 69 | ||||||||||||||||||||||||||||||||||||
| Other (1) | 2 | 69 | 72 | 2 | 81 | 84 | 7 | 149 | 155 | 4 | 156 | 162 | ||||||||||||||||||||||||||||||||||||
| Other (3) | — | 31 | 31 | (2 | ) | 41 | 40 | (1 | ) | 61 | 59 | — | 79 | 79 | ||||||||||||||||||||||||||||||||||
| Revenues | $ | 388 | $ | 1,219 | $ | 1,607 | $ | 371 | $ | 1,237 | $ | 1,608 | $ | 758 | $ | 2,471 | $ | 3,229 | $ | 697 | $ | 2,449 | $ | 3,146 | ||||||||||||||||||||||||
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. Revenues from Jada were previously reported as part of Other Women's Health. Revenue from an arrangement for the sale of generic etonogestrel/ethinyl estradiol vaginal ring is included in Other Women's Health.
(3) Includes manufacturing sales to third parties.
TABLE 3
Organon & Co.
Sales by geographic area
(Unaudited, $ in millions)
| Three Months
Ended June 30, | Six Months Ended
June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Europe and Canada | $ | 457 | $ | 467 | $ | 907 | $ | 867 | ||||||||
| United States | 388 | 371 | 758 | 697 | ||||||||||||
| Asia Pacific and Japan | 260 | 261 | 546 | 585 | ||||||||||||
| China | 216 | 234 | 421 | 459 | ||||||||||||
| Latin America, Middle East, Russia, and Africa | 251 | 234 | 525 | 448 | ||||||||||||
| Other (1) | 35 | 41 | 72 | 90 | ||||||||||||
| Revenues | $ | 1,607 | $ | 1,608 | $ | 3,229 | $ | 3,146 | ||||||||
(1) Other includes manufacturing sales to third parties.
TABLE 4
Organon & Co.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics
(Unaudited, $ in millions)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| GAAP Gross Profit | $ | 939 | $ | 968 | $ | 1,896 | $ | 1,926 | ||||||||
| Adjusted for: | ||||||||||||||||
| Spin-related costs (1) | 3 | 10 | 6 | 20 | ||||||||||||
| Manufacturing network costs (2) | 15 | — | 25 | — | ||||||||||||
| Stock-based compensation | 5 | 4 | 9 | 8 | ||||||||||||
| Amortization | 34 | 30 | 67 | 59 | ||||||||||||
| Other | — | — | — | 2 | ||||||||||||
| Adjusted Non-GAAP Gross Profit | $ | 996 | $ | 1,012 | $ | 2,003 | $ | 2,015 | ||||||||
(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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| GAAP Gross Margin | 58.4 | % | 60.2 | % | 58.7 | % | 61.2 | % | ||||||||
| Total impact of Non-GAAP adjustments | 3.6 | % | 2.7 | % | 3.3 | % | 2.8 | % | ||||||||
| Adjusted Non-GAAP Gross Margin | 62.0 | % | 62.9 | % | 62.0 | % | 64.0 | % | ||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| GAAP Selling, general and administrative expenses | $ | 437 | $ | 451 | $ | 868 | $ | 886 | ||||||||
| Adjusted for: | ||||||||||||||||
| Spin-related costs (1) | (29 | ) | (44 | ) | (69 | ) | (90 | ) | ||||||||
| Stock-based compensation | (18 | ) | (17 | ) | (36 | ) | (32 | ) | ||||||||
| Other | — | — | — | (1 | ) | |||||||||||
| Adjusted Non-GAAP Selling, general and administrative expenses | $ | 390 | $ | 390 | $ | 763 | $ | 763 | ||||||||
(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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| GAAP Research and development expenses | $ | 116 | $ | 128 | $ | 228 | $ | 257 | ||||||||
| Adjusted for: | ||||||||||||||||
| Spin-related costs (1) | (1 | ) | (3 | ) | (3 | ) | (6 | ) | ||||||||
| Stock-based compensation | (5 | ) | (4 | ) | (9 | ) | (7 | ) | ||||||||
| Adjusted Non-GAAP Research and development expenses | $ | 110 | $ | 121 | $ | 216 | $ | 244 | ||||||||
(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
Organon & Co.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Continued)
(Unaudited, $ in millions except per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| GAAP Reported Net Income | $ | 195 | $ | 242 | $ | 396 | $ | 419 | ||||||||
| Adjusted for: | ||||||||||||||||
| Cost of sales adjustments | 57 | 44 | 107 | 89 | ||||||||||||
| Selling, general and administrative adjustments | 47 | 61 | 105 | 123 | ||||||||||||
| Research and development adjustments | 6 | 7 | 12 | 13 | ||||||||||||
| Restructuring | — | — | 23 | 4 | ||||||||||||
| Other expense, net | 6 | 4 | 10 | 10 | ||||||||||||
| Tax impact on adjustments above(1) | (22 | ) | (22 | ) | (49 | ) | (46 | ) | ||||||||
| Non-GAAP Adjusted Net Income | $ | 289 | $ | 336 | $ | 604 | $ | 612 | ||||||||
(1) For the three months ended June 30, 2024 and 2023, the GAAP income tax rates were 17.3% and 5.0%, respectively, the non-GAAP income tax rates were 17.8% and 9.4%, respectively. For the six months ended June 30, 2024 and 2023, the GAAP income tax rates were 16.0% and 14.4%, respectively, the non-GAAP income tax rates were 17.1% and 16.0%, 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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| GAAP Diluted Earnings per Share | $ | 0.75 | $ | 0.95 | $ | 1.53 | $ | 1.64 | ||||||||
| Total impact of Non-GAAP adjustments | $ | 0.37 | $ | 0.36 | $ | 0.81 | $ | 0.75 | ||||||||
| Non-GAAP Diluted Earnings per Share | $ | 1.12 | $ | 1.31 | $ | 2.34 | $ | 2.39 | ||||||||
TABLE 5
Organon & Co.
Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA
(Unaudited, $ in millions)
| Three Months
Ended June 30, | Six Months Ended
June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Net income | $ | 195 | $ | 242 | $ | 396 | $ | 419 | ||||||||
| Depreciation (1) | 31 | 28 | 61 | 56 | ||||||||||||
| Amortization | 34 | 30 | 67 | 59 | ||||||||||||
| Interest expense | 131 | 132 | 262 | 264 | ||||||||||||
| Taxes on income | 40 | 12 | 75 | 70 | ||||||||||||
| EBITDA | $ | 431 | $ | 444 | $ | 861 | $ | 868 | ||||||||
| Restructuring costs | — | — | 23 | 4 | ||||||||||||
| Spin-related costs (2) | 39 | 61 | 88 | 126 | ||||||||||||
| Manufacturing network related (3) | 15 | — | 25 | — | ||||||||||||
| Other costs | — | — | — | 3 | ||||||||||||
| Stock-based compensation | 28 | 25 | 54 | 47 | ||||||||||||
| Adjusted EBITDA (Non-GAAP) | $ | 513 | $ | 530 | $ | 1,051 | $ | 1,048 | ||||||||
| Adjusted EBITDA margin (Non-GAAP) | 31.9 | % | 33.0 | % | 32.5 | % | 33.3 | % | ||||||||
(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, $19 million and $31 million for the three months ended June 30, 2024 and 2023, respectively, and $40 million and $68 million for the six months ended June 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 and $8 million for the three months ended June 30, 2024 and 2023, respectively, and $20 million and $14 million for the six months ended June 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.
As the costs described in (1) through (3) 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.
Exhibit 99.2
Second Quarter 2024 Earnings Organon
Disclaimer statement Cautionary Note Regarding Forward - Looking Statements Except for historical information, this presentation includes “forward - looking statements” within the meaning of the safe harbo r 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 pr osp ects, including full - year 2024 guidance estimates and predictions regarding other financial information and metrics, franchise and product performance and strategy expectations for future per iod s. Forward - looking statements may be identified by words such "foresees," “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” "would," "potentially," "intends, " " seeks," "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 under lyi ng 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 ca re 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 exec ute 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 channel s; 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 cl ass competition in the markets in which the company operates; global tensions, which may result in disruptions in the broader global economic environment; uncertainty regarding the U.S. federal bud get and debt ceiling, and the impact of a potential U.S. federal government shutdown; governmental initiatives that adversely impact our marketing activities, particularly in China; volatili ty 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; difficulties wit h p erformance 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 op erations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as our products lose patent protection; any failure by us to obt ain an additional period of market exclusivity in the United States for Nexplanon subsequent to the expiration of certain current patents in 2027; difficulties implementing or executing on our acqu isi tion strategy or failure to recognize the benefits of such acquisitions; and the impact of higher selling and promotional costs. The company undertakes no obligation to publicly update any forward - looking statement, whether as a result of new information, f uture 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 Securiti es 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). See Slides 19 - 21 of this presentation for a reconciliation of non - GAAP measures. 2
Disclaimer statement, cont. Cautionary Note Regarding Non - GAAP Financial Measures This presentation contains “non - GAAP financial measures,” which are financial measures that either exclude or include amounts th at 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”). Speci fic ally, 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 dilu ted EPS, which are not recognized terms under GAAP and are presented only as a supplement to the company’s GAAP financial statements. This presentation also provides certain measures t hat 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 com paring 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 GAA P. 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 Slides 19 - 21 of this presentation 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 co mpany 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 expens es, 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 on going 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 t o meaningfully communicate its underlying business performance, financial condition and results of operations. 3
Second quarter 2024 highlights 4 • Revenue of $1.6 billion , up 2% ex - FX • Diluted EPS of $0.75, Adjusted Diluted EPS of $1.12 • Adjusted EBITDA of $513 million, inclusive of $15 million of IPR&D and milestones See Slides 19 - 21 of this presentation for a reconciliation of non - GAAP measures.
Women's Health • Franchise growth of 3% ex - FX • Strong growth in Nexplanon and Marvelon/Mercilon , offset performance of Fertility and NuvaRing • Franchise growth of 22% ex - FX • Ontruzant volume growth driven by favorable tender • Hadlima continuing to gain traction in U.S. 5 Established Brands Biosimilars Women's Health • Franchise down 1% ex - FX, YTD growth of 1% ex - FX • Expect to achieve flat performance in Established Brands in 2024 , ex - FX
$ mil Q2 - 24 Q2 - 23 Actual VPY Ex - FX VPY 2024 YTD 2023 YTD Actual VPY Ex - FX VPY Europe and Canada 457 467 (2)% (1)% 907 867 5% 4% United States 388 371 5% 5% 758 697 9% 9% Asia Pacific and Japan 260 261 — % 5% 546 585 (7)% (2)% Latin America, Middle East, Russia and Africa 251 234 7% 8% 525 448 17% 21% China 216 234 (8)% (4)% 421 459 (8)% (4)% Other (1) 35 41 (10)% (10)% 72 90 (20)% (21)% Total Revenues 1,607 1,608 — % 2% 3,229 3,146 3% 4% 6 Totals may not foot due to rounding and percentages are computed using unrounded amounts. (1) Other includes manufacturing sales to Merck & Co., Rahway, NJ and other third parties . ~75% of YTD sales generated ex - US Strength in largest markets, year to date
Flat as reported, and +2% at constant currency $ mil 7 Minimal year to date impact from LOE, VBP, price (1) LOE = Loss of Exclusivity (2) VBP = Volume Based Procurement (3) Other includes manufacturing sales to Merck & Co., Rahway, NJ and other third parties . (3) (1) (2) ~ ~ ~ ~ ~ ~ ~(200) bps headwind
Women’s Health Women’s Health Revenues $ mil Q2 - 24 Q2 - 23 Act VPY Ex - FX VPY 2024 YTD 2023 YTD Act VPY Ex - FX VPY Nexplanon ® (contraception) 242 214 13% 13% 462 380 22% 22% NuvaRing ® (contraception) 29 46 (36)% (35)% 67 94 (29)% (27)% Marvelon Œ / Mercilon Œ (contraception) 41 29 38% 42% 73 67 10% 13% Follistim AQ ® (fertility) 62 70 (11)% (9)% 108 125 (13)% (11)% Ganirelix Acetate Injection (fertility) 27 34 (20)% (17)% 56 63 (12)% (9)% Jada ® (device) 14 11 31% 31% 27 18 52% 52% Other Women's Health products 34 35 (2)% (1)% 79 73 7% 7% Total Women's Health 449 438 3% 3% 872 819 6% 8% • Strong growth in Nexplanon and Marvelon/ Mercilon offset performance of Nuva R ing and Fertility • Continued uptake in Jada 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 . 8
Biosimilars Biosimilars Revenues $ mil Q2 - 24 Q2 - 23 Act VPY Ex - FX VPY 2024 YTD 2023 YTD Act VPY Ex - FX VPY Renflexis ® 69 70 (2)% (2)% 138 132 5% 5% Ontruzant ® 48 33 46% 46% 87 54 62% 62% Brenzys Œ 12 13 (4)% (4)% 36 32 13% 14% Aybintio Œ 7 12 (39)% (38)% 15 22 (30)% (30)% Hadlima ® 28 7 NM NM 58 12 NM NM Biosimilars 164 135 22% 22% 334 251 33% 33% 9 • Hadlima uptake continues following U.S. launch • Ontruzant volume growth driven by favorable tender 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 .
Established Brands Established Brands Revenues $ mil Q2 - 24 Q2 - 23 Act VPY Ex - FX VPY 2024 YTD 2023 YTD Act VPY Ex - FX VPY Cardiovascular 344 401 (14)% (12)% 709 785 (10)% (7)% Respiratory 248 250 (1)% 2% 525 542 (3)% — % Non - Opioid Pain, Bone & Derm 218 200 9% 11% 434 385 13% 15% Other 153 144 6% 8% 297 285 4% 6% Total Est. Brands 963 995 (3)% (1)% 1,964 1,997 (2)% 1% 10 • New migraine products and recovery in injectable steroids largely offset VBP, expected price pressure in Japan and ERP - related shipment phasing • Expect flat performance for the franchise in 2024 ex - FX Totals may not foot due to rounding .
Containment of operating costs partially offset gross margin pressure All numbers presented on non - GAAP basis except revenue and IPR&D (1) Q2 - 24 Q2 - 23 Actual VPY 2024 YTD 2023 YTD Actual VPY Revenue 1,607 1,608 — % 3,229 3,146 3% Cost of sales 611 596 3% 1,226 1,131 8% Adjusted Gross profit 996 1,012 (2)% 2,003 2,015 (1)% Selling, general and administrative 390 390 — % 763 763 — % R&D 110 121 (9)% 216 244 (11)% Acquired IPR&D and milestones 15 — NM 30 8 NM Total research and development including IPR&D 125 121 3% 246 252 (2)% Adjusted EBITDA 513 530 (3)% 1,051 1,048 — % Adjusted diluted EPS 1.12 1.31 (15)% 2.34 2.39 (2)% Per share impact to diluted EPS from acquired IPR&D and milestones (0.05) — NM (0.09) — NM Adjusted Gross margin 62.0% 62.9% 62.0% 64.0% Adjusted EBITDA margin 31.9% 33.0% 32.5% 33.3% 11 (1) See Slides 19 - 21 of this presentation for a reconciliation of non - GAAP measures to their respective GAAP measures.
12 (USD millions) 1H 2024 Adjusted EBITDA $1,051 Less: Net cash interest expense (247) Less: Cash taxes (102) Less: Change in net working capital (204) Less: CapEx (43) Free Cash Flow Before One Time Costs $455 Less: One time spin - related costs (117) Less: Other one - time costs (1) (70) Free Cash Flow (2) $268 • Timing - related improvement in Q2 working capital • Expect one - time spin - related costs of ~$200M for full year 2024 On track to deliver ~$1B of free cash flow before one - time spin - related costs for full year 2024 (1) Includes operating expenses associated with restructuring initiatives and the planned exits from supply agreements with Merck & Co., Rahway, NJ . (2) Free cash flow represents net cash flows provided by operating activities plus capital expenditures and the effect of exc han ge rate changes on cash and cash equivalents.
13 Net leverage ratio ~4.1x at June 2024* Expect to end 2024 with net leverage below 4.0x $ mil Dec 2021 Dec 2022 Dec 2023 Mar 2024 Jun 2024 Cash and cash equivalents 737 706 693 575 704 Gross Debt (1) 9,134 8,913 8,760 8,714 8,656 Net Debt (1) 8,397 8,207 8,067 8,139 7,952 * The definition of net debt is in the company's credit agreement and excludes unamortized fees; but includes capitalized lea se obligations. Additionally, the LTM EBITDA calculation excludes acquired IPR&D and milestone expense . (1) Debt figures are net of discounts and unamortized fees of $124 million, $105 million, $84 million, $79 million and $108 mil lion as of December 31, 2021, December 31, 2022, December 31, 2023, March 31, 2024 and June 30, 2024, respectively.
2024 expected to be third consecutive year of revenue growth at constant currency FY 2023 LOE China VB P Price Volume Supply/Other FX FY 2024 $6,263 (70) - (90) (30) - (50) (180) - (200) 500 - 600 (20) - (25) (110) - (140) $6,250 - $6,450 (1) LOE = Loss of Exclusivity (2) VBP = Volume Based Procurement (3) Other includes manufacturing sales to Merck & Co., Rahway, NJ and other third parties. (0.2%) to +3.0% reported, +2.0% to +4.7% growth at constant currency (1) (2) (3) $ mil 1 st Half 2 nd Half Legend: 14
Tightening of revenue range; no change to Adj. EBITDA margin range 15 Provided on a non - GAAP basis, except revenue Prior guidance Current guidance Revenues $6.2B - $6.5B $6.25B - $6.45B Adjusted gross margin 61.0% - 63.0% Unchanged SG&A $1.5B - $1.7B Unchanged R&D $400M - $500M $430M - $530M* 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 *Updated R&D expense guidance includes $30 million of IPR&D and milestone expense incurred year - to - date June 30, 2024. R&D guida nce does not take into consideration a forward looking view of IPR&D and milestone expense.
Q&A
Appendix
Franchise performance $ mil Q2 2024 Q2 2023 Actual VPY Ex - FX VPY 2024 YTD 2023 YTD Actual VPY Ex - FX VPY Women’s Health 449 438 3% 3% 872 819 6% 8% Biosimilars 164 135 22% 22% 334 251 33% 33% Est. Brands 963 995 (3)% (1)% 1,964 1,997 (2)% 1% Other (1) 31 40 (20)% (20)% 59 79 (23)% (24)% Total Revenues 1,607 1,608 — % 2% 3,229 3,146 3% 4% Totals may not foot due to rounding and percentages are computed using unrounded amounts. (1) Other includes manufacturing sales to Merck & Co., Rahway, NJ and other third parties. 18
Reconciliation of GAAP Reported to Non - GAAP Adjusted Metrics ($ in millions) Q2 2024 Q2 2023 2024 YTD 2023 YTD GAAP Gross Profit $ 939 $ 968 $ 1,896 $ 1,926 Adjusted for: Spin - related costs (1) $ 3 $ 10 $ 6 $ 20 Manufacturing network costs (2) $ 15 $ — 25 — Stock - based compensation $ 5 $ 4 9 8 Amortization $ 34 $ 30 67 59 Other — — — 2 Adjusted Non - GAAP Gross Profit $ 996 $ 1,012 $ 2,003 $ 2,015 (1) Spin - related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to t he EBITDA reconciliation on page 21 . (2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc. , R ahway NJ, US. For additional details refer to the EBITDA reconciliation on page 21 . Q2 2024 Q2 2023 2024 YTD 2023 YTD GAAP Gross Margin 58.4 % 60.2 % 58.7 % 61.2 % Total impact of Non - GAAP adjustments 3.6 % 2.7 % 3.3 % 2.8 % Adjusted Non - GAAP Gross Margin 62.0 % 62.9 % 62.0 % 64.0 % Q2 2024 Q2 2023 2024 YTD 2023 YTD GAAP Selling, general and administrative expenses $ 437 $ 451 $ 868 $ 886 Adjusted for: Spin - related costs (1) $ (29) $ (44) $ (69) $ (90) Stock - based compensation (18) (17) (36) (32) Other — — — (1) Adjusted Non - GAAP Selling, general and administrative expenses $ 390 $ 390 $ 763 $ 763 (1) Spin - related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to the EBITDA reconciliation on page 21 . 19
Reconciliation of GAAP Reported to Non - GAAP Adjusted Metrics ($ in millions, except per share amounts) Q2 2024 Q2 2023 2024 YTD 2023 YTD GAAP Research and development expenses $ 116 $ 128 $ 228 $ 257 Adjusted for: Spin - related costs (1) (1) (3) (3) (6) Stock - based compensation (5) (4) (9) (7) Adjusted Non - GAAP Research and development expenses $ 110 $ 121 $ 216 $ 244 (1) Spin - related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to t he EBITDA reconciliation on page 21 . Q2 2024 Q2 2023 2024 YTD 2023 YTD GAAP Reported Net Income $ 195 $ 242 $ 396 $ 419 Adjusted for: Cost of sales adjustments 57 44 107 89 Selling, general and administrative adjustments 47 61 105 123 Research and development adjustments 6 7 12 13 Restructuring — — 23 4 Other expense, net 6 4 10 10 Tax impact on adjustments above (1) (22) (22) (49) (46) Non - GAAP Adjusted Net Income $ 289 $ 336 $ 604 $ 612 (1) For the three months ended June 30, 2024 and 2023, the GAAP income tax rates were 17.3% and 5.0%, respectively, the non - GAAP income tax rates were 17.8% and 9.4%, respectively. For the six months ended June 30, 2024 and 2023, the GAAP income tax rates were 16.0% and 14.4%, respect ively, the non - GAAP income tax rates were 17.1% and 16.0%, respectively. These adjustments represent the estimated tax impacts on the reconciling items by a ppl ying the statutory rate and applicable law of the originating territory of the non - GAAP adjustments. Q2 2024 Q2 2023 2024 YTD 2023 YTD GAAP Diluted Earnings per Share $ 0.75 $ 0.95 $ 1.53 $ 1.64 Total impact of Non - GAAP adjustments $ 0.37 $ 0.36 $ 0.81 $ 0.75 Non - GAAP Diluted Earnings per Share $ 1.12 $ 1.31 $ 2.34 $ 2.39 20
GAAP Net Income to Adjusted EBITDA Unaudited, $ in millions Q2 2024 Q2 2023 2024 YTD 2023 YTD Net income $ 195 $ 242 $ 396 $ 419 Depreciation (1) 31 28 61 56 Amortization 34 30 67 59 Interest expense 131 132 262 264 Taxes on income 40 12 75 70 EBITDA $ 431 $ 444 $ 861 $ 868 Restructuring costs — — 23 4 Spin - related costs (2) 39 61 88 126 Manufacturing network related (3) 15 — 25 — Other costs — — — 3 Stock - based compensation 28 25 54 47 Adjusted EBITDA (Non - GAAP) $ 513 $ 530 $ 1,051 $ 1,048 Adjusted EBITDA margin (Non - GAAP) 31.9 % 33.0 % 32.5 % 33.3 % 21 ( 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, $ 19 million and $ 31 million for the three months ended June 30 , 2024 and 2023 , respectively, and $ 40 million and $ 68 million for the six months ended June 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 and $ 8 million for the three months ended June 30 , 2024 and 2023 , respectively and $ 20 million and $ 14 million for the six months ended June 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 . As the costs described in ( 1 ) through ( 3 ) 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 provide meaningful, supplemental, information that the company believes will enhance an investor's understanding of the company's ongoing operating performance .
Number of products 14 5 55 Women’s Health Biosimilars Established Brands Broad and diverse portfolio 22 TM TM
Cover |
Aug. 06, 2024 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Aug. 06, 2024 |
| Entity File Number | 001-40235 |
| Entity Registrant Name | Organon & Co. |
| Entity Central Index Key | 0001821825 |
| Entity Tax Identification Number | 46-4838035 |
| Entity Incorporation, State or Country Code | DE |
| Entity Address, Address Line One | 30 Hudson Street |
| Entity Address, Address Line Two | Floor 33 |
| Entity Address, City or Town | Jersey City |
| Entity Address, State or Province | NJ |
| Entity Address, Postal Zip Code | 07302 |
| City Area Code | 551 |
| Local Phone Number | 430-6900 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Title of 12(b) Security | Common Stock, par value $0.01 per share |
| Trading Symbol | OGN |
| Security Exchange Name | NYSE |
| Entity Emerging Growth Company | false |
1 Year Organon Chart |
1 Month Organon Chart |
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