UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 2, 2024
Organon & Co.
(Exact name of registrant as specified in its charter)
Delaware | 001-40235 | 46-4838035 | ||
(State or other jurisdiction of | (Commission File Number) | (I.R.S. Employer Identification No.) | ||
incorporation) | ||||
30 Hudson Street, Floor 33, Jersey City, NJ |
07302 | |||
(Address and principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (551) 430-6900 |
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 | ||
Common Stock, par value $0.01 per share | OGN | NYSE |
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 May 2, 2024, Organon & Co. (the “Company”) issued a press release (the “Earnings Release”) regarding its results for the quarter ended March 31, 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 May 2, 2024, the Company made available the Company Information Presentation relating to its financial results for the quarter ended March 31, 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 May 2, 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: May 2, 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 First Quarter Ended March 31, 2024
• | First quarter 2024 revenue of $1,622 million, up 5% on an as-reported basis and 7% at constant currency |
• | First quarter 2024 diluted earnings per share of $0.78 and non-GAAP Adjusted diluted earnings per share of $1.22; both reported and non-GAAP Adjusted diluted earnings per share include $15 million expense, or $(0.05) per share, for acquired in-process research and development (IPR&D) and milestones |
• | First quarter 2024 net income of $201 million and Adjusted EBITDA (non-GAAP) of $538 million |
• | Full year 2024 financial guidance ranges affirmed |
Jersey City, N.J., May 2, 2024 – Organon (NYSE: OGN) today announced its results for the first quarter ended March 31, 2024.
"We entered this year with a clear focus: to deliver our 2024 financial targets while staying true to our mission of improving the health of women, and the first quarter was a very solid start," said Kevin Ali, Organon's Chief Executive Officer. "We remain confident in our ability to deliver our third year of revenue growth on a constant currency basis and we remain committed to delivering full-year non-GAAP Adjusted EBITDA margins that are in line with last year, or better." For the first quarter of 2024, total revenue was $1,622 million, an increase of 5% on an as-reported basis and an increase of 7% excluding the impact of foreign currency (ex-FX), compared with the first quarter of 2023.
First Quarter 2024 Revenue
in $ millions | Q1 2024 | Q1 2023 | VPY | VPY ex-FX | ||||||||||||
Women’s Health | $ | 422 | $ | 381 | 11 | % | 12 | % | ||||||||
Biosimilars | 170 | 116 | 46 | % | 46 | % | ||||||||||
Established Brands | 1,001 | 1,002 | —% | 2 | % | |||||||||||
Other (1) | 29 | 39 | (27 | )% | (29 | )% | ||||||||||
Revenues | $ | 1,622 | $ | 1,538 | 5 | % | 7 | % |
(1) Other includes manufacturing sales to third parties.
Women’s Health revenue increased 11% on an as-reported basis, and increased 12% ex-FX in the first quarter of 2024 compared with the first quarter of 2023 primarily driven by 34% ex-FX growth in Nexplanon® (etonogestrel implant). Nexplanon's strong performance was primarily due to the favorable year-over-year comparison of customer purchasing patterns associated with the timing of U.S list-price adjustments, coupled with favorable price and discount rates in the U.S. and the favorable timing of tenders to markets outside of the U.S. Worldwide sales of the Jada® system, a device intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, nearly doubled compared with the prior year period, benefiting from continued uptake in the United States following the product's launch in early 2022. Performance in the Women's Health franchise was partially offset by sales of NuvaRing® (estonogestrel / ethinyl estradiol vaginal ring), a vaginal contraceptive product, which declined 19% ex-FX during the period due to ongoing generic competition. The fertility portfolio was down 2% ex-FX in the first quarter, following a very strong fourth quarter of 2023 for Follistim AQ® (follitropin beta injection) which benefited from a one-time buy-in associated with the planned exit of a temporary spin-off related commercial arrangement in the U.S. and increased demand that was largely tied to onboarding a new customer.
Biosimilars revenue grew 46% on an as-reported basis and 46% ex-FX in the first quarter of 2024, compared with the first quarter of 2023. This revenue growth was primarily driven by Ontruzant® (trastuzumab-dttb), which benefited from incremental demand from a tender in Brazil. Renflexis® (infliximab-abda) grew 12% ex-FX primarily due to continued demand growth in the U.S and Canada partially offset by unfavorable rates in the U.S. Worldwide revenue of Hadlima® (adalimumab-bwwd) was $30 million during the three months ended March 31, 2024, compared with $5 million in the prior year period, primarily related to continued uptake following the product's July 2023 launch in the U.S.
Established Brands revenue was flat on an as-reported basis and grew 2% ex-FX in the first quarter of 2024. Contribution from the recent licensing of Emgality® (galcanezumab) and RayvowTM (lasmiditan)(1, 2), together with a recovery in certain injectable steroid products following last year's market action offset the impacts of Volume Based Procurement initiatives in China. Performance was equally driven by growth in volume and price. The company expects revenue growth in the Established Brands franchise to be about flat for full year 2024 on an ex-FX basis.
(1) Emgality is a trademark registered in the United States in the name of Eli Lilly and Company (used under license).
(2) Rayvow is a registered trademark of Eli Lilly in the European Union and other countries (used under license).
First Quarter 2024 Profitability
in $ millions, except per share amounts | Q1 2024 | Q1 2023 | VPY | |||||||||
Revenues | $ | 1,622 | $ | 1,538 | 5 | % | ||||||
Cost of sales | 665 | 580 | 15 | % | ||||||||
Gross profit | 957 | 958 | —% | |||||||||
Non-GAAP Adjusted gross profit (1) | 1,007 | 1,003 | —% | |||||||||
Net income | 201 | 177 | 14 | % | ||||||||
Non-GAAP Adjusted net income (1) | 315 | 276 | 14 | % | ||||||||
Diluted Earnings per Share (EPS) | 0.78 | 0.69 | 13 | % | ||||||||
Non-GAAP Adjusted diluted EPS (1) | 1.22 | 1.08 | 13 | % | ||||||||
Acquired in-process research & development (IPR&D) and milestones | 15 | 8 | — | |||||||||
Per share impact to diluted EPS from acquired IPR&D and milestones | (0.05 | ) | (0.03 | ) | — | |||||||
Adjusted EBITDA (Non-GAAP) (1,2) | 538 | 518 | 4 | % | ||||||||
Q1 2024 | Q1 2023 | |||||||||||
Gross margin | 59.0 | % | 62.3 | % | ||||||||
Non-GAAP Adjusted gross margin (1) | 62.1 | % | 65.2 | % | ||||||||
Adjusted EBITDA margin (Non-GAAP) (1, 2) | 33.2 | % | 33.7 | % |
(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 first quarter of 2024 and $8 million in the first quarter of 2023 related to Acquired IPR&D and milestones. |
Gross margin was 59.0% as-reported and 62.1% on a non-GAAP adjusted basis in the first quarter of 2024 compared with 62.3% as-reported and 65.2% on a non-GAAP adjusted basis in the first quarter of 2023. The lower non-GAAP Adjusted gross margin was primarily related to unfavorable product mix, foreign exchange translation and higher inflation impacts to material and distribution costs.
Net income for the first quarter of 2024 was $201 million, or $0.78 per diluted share, compared with $177 million, or $0.69 per diluted share, in the first quarter of 2023. Non-GAAP Adjusted net income was $315 million, or $1.22 per diluted share, compared with $276 million, or $1.08 per diluted share, in 2023.
Non-GAAP Adjusted EBITDA margin was 33.2% in the first quarter of 2024 compared with 33.7% in the first quarter of 2023 primarily due to cost containment initiatives targeting operating expenses, particularly in research and development, that were offset by higher cost of goods sold.
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 June 13, 2024, to stockholders of record at the close of business on May 13, 2024.
As of March 31, 2024, cash and cash equivalents were $575 million, and debt was $8.7 billion.
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 February 15, 2024 |
Current guidance | |||
Revenues | $6.2B - $6.5B | Unchanged | ||
Adjusted gross margin | 61.0% - 63.0% | Unchanged | ||
SG&A | $1.5B - $1.7B | Unchanged | ||
R&D* | $400M - $500M | Unchanged | ||
Adjusted EBITDA margin (Non-GAAP) | 31.0% - 33.0% | Unchanged | ||
Interest | ~$520M | Unchanged | ||
Depreciation | ~$130M | Unchanged | ||
Effective non-GAAP tax rate | 18.5% - 20.5% | Unchanged | ||
Fully diluted weighted average shares outstanding | ~259M | Unchanged |
*R&D expense includes $15 million of IPR&D and milestone expense year-to-date March 31, 2024. R&D guidance does not take into consideration a forward looking view of IPR&D and milestone expense.
Webcast Information
Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its first quarter 2024 financial results. To listen to the event and view the presentation slides via webcast, join from the Organon Investor Relations website at https://www.organon.com/investor-relations/events-and-presentations/. A replay of the webcast will be available approximately two hours after the conclusion of the live event on the company’s website. Institutional investors and analysts interested in participating in the call must register in advance by clicking on this link:
https://registrations.events/direct/Q4I58511
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 a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.
Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.
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 "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.
Risks and uncertainties include, but are not limited to, an inability to fully execute on our product development and commercialization plans within the United States or internationally; an inability to adapt to the industry-wide trend toward highly discounted channels; changes in tax laws or other tax guidance that could adversely affect our cash tax liability, effective tax rates, and results of operations and lead to greater audit scrutiny; an inability to execute on our business development strategy or realize the benefits of our planned acquisitions; efficacy, safety, or other quality concerns with respect to marketed products, including market actions such as recalls, withdrawals, or declining sales; political and social pressures, or regulatory developments, that adversely impact demand for, availability of, or patient access to contraception or fertility products; general economic factors, including recessionary pressures, interest rate and currency exchange rate fluctuations; general industry conditions and competition; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances; new products and patents attained by competitors; the impact of higher selling and promotional costs; any failure by Organon to obtain an additional period of market exclusivity in the United States for Nexplanon subsequent to the expiration of certain key patents in 2027; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict its future financial results and performance; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; difficulties developing and sustaining relationships with commercial counterparties; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
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 March 31, |
||||||||
2024 | 2023 | |||||||
Revenues | $ | 1,622 | $ | 1,538 | ||||
Costs, Expenses and Other | ||||||||
Cost of sales | 665 | 580 | ||||||
Selling, general and administrative | 431 | 435 | ||||||
Research and development | 112 | 129 | ||||||
Acquired in-process research and development and milestones | 15 | 8 | ||||||
Restructuring costs | 23 | 4 | ||||||
Interest expense | 131 | 132 | ||||||
Exchange losses | 6 | 9 | ||||||
Other expense, net | 3 | 6 | ||||||
1,386 | 1,303 | |||||||
Income Before Income Taxes | 236 | 235 | ||||||
Taxes on income | 35 | 58 | ||||||
Net Income | $ | 201 | $ | 177 | ||||
Earnings per Share: | ||||||||
Basic | $ | 0.78 | $ | 0.70 | ||||
Diluted | $ | 0.78 | $ | 0.69 | ||||
Weighted Average Shares Outstanding: | ||||||||
Basic | 255,695 | 254,392 | ||||||
Diluted | 258,362 | 256,170 |
TABLE 2
Organon & Co.
Sales by top products
(Unaudited, $ in millions)
Three Months Ended March 31, | ||||||||||||||||||||||||
2024 | 2023 | |||||||||||||||||||||||
U.S. | Int’l | Total | U.S. | Int’l | Total | |||||||||||||||||||
Women’s Health | ||||||||||||||||||||||||
Nexplanon/Implanon NXT | $ | 153 | $ | 67 | $ | 220 | $ | 114 | $ | 52 | $ | 165 | ||||||||||||
Follistim AQ | 11 | 35 | 46 | 26 | 29 | 55 | ||||||||||||||||||
NuvaRing (1) | 16 | 22 | 38 | 25 | 24 | 49 | ||||||||||||||||||
Ganirelix Acetate Injection | 6 | 23 | 29 | 6 | 23 | 30 | ||||||||||||||||||
Marvelon/Mercilon | — | 33 | 33 | — | 37 | 37 | ||||||||||||||||||
Jada | 13 | — | 13 | 7 | — | 7 | ||||||||||||||||||
Other Women’s Health (1) (2) | 15 | 28 | 43 | 9 | 28 | 38 | ||||||||||||||||||
Biosimilars | ||||||||||||||||||||||||
Renflexis | 55 | 14 | 69 | 55 | 7 | 62 | ||||||||||||||||||
Ontruzant | 8 | 31 | 39 | 13 | 8 | 21 | ||||||||||||||||||
Brenzys | — | 24 | 24 | — | 19 | 19 | ||||||||||||||||||
Aybintio | — | 8 | 8 | — | 10 | 10 | ||||||||||||||||||
Hadlima | 22 | 8 | 30 | — | 5 | 5 | ||||||||||||||||||
Established Brands | ||||||||||||||||||||||||
Cardiovascular | ||||||||||||||||||||||||
Zetia (1) | 2 | 82 | 84 | 2 | 87 | 89 | ||||||||||||||||||
Vytorin | 1 | 27 | 28 | 2 | 28 | 29 | ||||||||||||||||||
Atozet | — | 132 | 132 | — | 128 | 128 | ||||||||||||||||||
Rosuzet | — | 16 | 16 | — | 18 | 18 | ||||||||||||||||||
Cozaar/Hyzaar | 3 | 65 | 67 | 2 | 83 | 85 | ||||||||||||||||||
Other Cardiovascular (1) (2) | — | 37 | 38 | 1 | 34 | 35 | ||||||||||||||||||
Respiratory | ||||||||||||||||||||||||
Singulair | 2 | 95 | 98 | 3 | 117 | 120 | ||||||||||||||||||
Nasonex (1) | — | 77 | 77 | — | 71 | 71 | ||||||||||||||||||
Dulera | 43 | 13 | 56 | 38 | 8 | 46 | ||||||||||||||||||
Clarinex | 1 | 36 | 37 | 1 | 39 | 39 | ||||||||||||||||||
Other Respiratory (1) (2) | 7 | 3 | 9 | 12 | 3 | 15 | ||||||||||||||||||
Non-Opioid Pain, Bone and Dermatology | ||||||||||||||||||||||||
Arcoxia | — | 75 | 75 | — | 71 | 71 | ||||||||||||||||||
Fosamax | 1 | 38 | 40 | — | 37 | 38 | ||||||||||||||||||
Diprospan | — | 29 | 29 | — | 14 | 14 | ||||||||||||||||||
Other Non-Opioid Pain, Bone and Dermatology (1) | 5 | 68 | 72 | 4 | 59 | 63 | ||||||||||||||||||
Other | ||||||||||||||||||||||||
Proscar | — | 26 | 26 | — | 27 | 27 | ||||||||||||||||||
Propecia | 2 | 21 | 23 | 2 | 31 | 33 | ||||||||||||||||||
Other (1) (4) | 5 | 89 | 94 | 4 | 76 | 80 | ||||||||||||||||||
Other (3) | — | 29 | 29 | — | 39 | 39 | ||||||||||||||||||
Revenues | $ | 371 | $ | 1,251 | $ | 1,622 | $ | 326 | $ | 1,212 | $ | 1,538 |
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.
(4) Includes revenues from the migraine medicines Emgality and Rayvow.
TABLE 3
Organon & Co.
Sales by geographic area
(Unaudited, $ in millions)
Three Months
Ended March 31, |
||||||||
2024 | 2023 | |||||||
Europe and Canada | $ | 450 | $ | 400 | ||||
United States | 371 | 326 | ||||||
Asia Pacific and Japan | 287 | 324 | ||||||
China | 206 | 225 | ||||||
Latin America, Middle East, Russia, and Africa | 274 | 214 | ||||||
Other (1) | 34 | 49 | ||||||
Revenues | $ | 1,622 | $ | 1,538 |
(1) Other includes manufacturing sales to third parties.
TABLE 4
Organon & Co.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
(Unaudited, $ in millions except per share amounts)
Three Months Ended March 31, 2024 | ||||||||||||||||||||||||||||||||
GAAP | Spin
related Costs(1) |
Manufacturing
Network Related Costs(2) |
Restructuring | Stock-based Compensation |
Amortization | Other | Non-GAAP Adjusted |
|||||||||||||||||||||||||
Cost of sales | $ | 665 | (3 | ) | (10 | ) | — | (4 | ) | (33 | ) | — | $ | 615 | ||||||||||||||||||
Gross profit | 957 | 3 | 10 | — | 4 | 33 | — | 1,007 | ||||||||||||||||||||||||
Gross margin | 59.0 | % | 62.1 | % | ||||||||||||||||||||||||||||
Selling, general and administrative | 431 | (40 | ) | — | — | (18 | ) | — | — | 373 | ||||||||||||||||||||||
Research and development | 112 | (2 | ) | — | — | (4 | ) | — | — | 106 | ||||||||||||||||||||||
Restructuring costs | 23 | — | — | (23 | ) | — | — | — | — | |||||||||||||||||||||||
Other expense (income), net | 3 | (4 | ) | — | — | — | — | — | (1 | ) | ||||||||||||||||||||||
Taxes on income(3) | 35 | 9 | 2 | 6 | 4 | 6 | — | 62 | ||||||||||||||||||||||||
Net income | 201 | 40 | 8 | 17 | 22 | 27 | — | 315 | ||||||||||||||||||||||||
Earnings per share - Diluted | $ | 0.78 | $ | 1.22 |
(1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US.
(2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US.
(3) Represents 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 March 31, 2023 | ||||||||||||||||||||||||||||
GAAP | Spin
related Costs(1) |
Restructuring | Stock-based
Compensation |
Amortization | Other(2) | Non-GAAP Adjusted |
||||||||||||||||||||||
Cost of sales | $ | 580 | (10 | ) | — | (4 | ) | (29 | ) | (2 | ) | $ | 535 | |||||||||||||||
Gross profit | 958 | 10 | — | 4 | 29 | 2 | 1,003 | |||||||||||||||||||||
Gross margin | 62.3 | % | 65.2 | % | ||||||||||||||||||||||||
Selling, general and administrative | 435 | (46 | ) | — | (15 | ) | — | (1 | ) | 373 | ||||||||||||||||||
Research and development | 129 | (3 | ) | — | (3 | ) | — | — | 123 | |||||||||||||||||||
Restructuring costs | 4 | — | (4 | ) | — | — | — | — | ||||||||||||||||||||
Other expense (income), net | 6 | (6 | ) | — | — | — | — | — | ||||||||||||||||||||
Taxes on income(3) | 58 | 13 | 1 | 4 | 6 | — | 82 | |||||||||||||||||||||
Net income | 177 | 52 | 3 | 18 | 23 | 3 | 276 | |||||||||||||||||||||
Earnings per share - Diluted | $ | 0.69 | $ | 1.08 |
(1) Spin-related costs includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US.
(2) Other costs primarily includes one-time costs related to inventory step-up adjustments and legal reserves.
(3) Represents the estimated tax impacts on the reconciling items by applying the statutory rate and applicable law of the originating territory of the non-GAAP adjustments.
TABLE 5
Organon & Co.
Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA
(Unaudited, $ in millions)
Three Months
Ended March 31, |
||||||||
2024 | 2023 | |||||||
Net Income | $ | 201 | $ | 177 | ||||
Depreciation (1) | 30 | 28 | ||||||
Amortization | 33 | 29 | ||||||
Interest expense | 131 | 132 | ||||||
Taxes on income | 35 | 58 | ||||||
EBITDA | $ | 430 | $ | 424 | ||||
Restructuring costs | 23 | 4 | ||||||
One-time costs (2) | 59 | 68 | ||||||
Stock-based compensation | 26 | 22 | ||||||
Adjusted EBITDA (Non-GAAP) | $ | 538 | $ | 518 | ||||
Adjusted EBITDA margin (Non-GAAP) | 33.2 | % | 33.7 | % |
(1) Excludes accelerated depreciation included in one-time costs.
(2) Represents spin-related, manufacturing network, and other one-time costs. 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, $21 million and $37 million for the three months ended March 31, 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 $14 million and $6 million for the three months ended March 31, 2024 and 2023, respectively, associated with temporary transition service agreements with Merck & Co., Rahway, NJ. Manufacturing network related costs, including exiting of temporary manufacturing and supply agreements with Merck & Co., Rahway, NJ, US, reflect accelerated depreciation, exit premiums, technology transfer costs, stability and qualification batch costs, and third-party contractor costs, and totaled $10 million for the three months ended March 31, 2024. As these costs 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.
Exhibit 99.2
First 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 that may affect our future results include, but are not limited to, pricing pressures globally, inclu din g 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 pric ing 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 industr y - w ide 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 gr eater audit scrutiny; expanded brand and class competition in the markets in which we operate; global tensions, which may result in disruptions in the broader global economic environment; uncertainty re gar ding 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, particul arl y 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 p rod ucts; 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, ma nuf acturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as our products lose patent protection; any f ail ure 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, 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 First quarter 2024 highlights 4 • Revenue of $1.6 billion, up 7% ex - FX ◦ All three franchises contributed to growth • Diluted EPS of $0.78, Adjusted Diluted EPS of $1.22 • Adjusted EBITDA of $538 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 12% ex - FX • Nexplanon up 34% ex - FX driven by favorable comparison to buy - out in Q1 2023; volume and price growth • Continued uptake in Jada • Franchise growth of 46% ex - FX • Ontruzant benefit from incremental demand in Brazil • Hadlima continuing to gain traction in U.S.
• Franchise growth of 2% ex - FX • Expect to achieve flat performance in Established Brands in 2024 5 Established Brands Biosimilars Women's Health $ mil Q1 - 24 Q1 - 23 Actual VPY Ex - FX VPY Europe and Canada 450 400 12% 10% United States 371 326 14% 14% Asia Pacific and Japan 287 324 (12)% (7)% China 206 225 (8)% (5)% Latin America, Middle East, Russia and Africa 274 214 28% 36% Other (1) 34 49 (28)% (30)% Total Revenues 1,622 1,538 5% 7% 6 (1) Other includes manufacturing sales to third parties. ~80% of Q1 sales generated ex - US Strong Q1 performance from largest markets +5% reported, and +7% at constant currency $ mil 7 Strong volume growth, driven by Nexplanon , Biosimilars (1) LOE = Loss of Exclusivity (2) VBP = Volume Based Procurement (3) Other includes manufacturing sales to third parties (3) (1) (2) ~ ~ ~ ~ ~ ~
Women’s Health Women’s Health Revenues $ mil Q1 - 24 Q1 - 23 Act VPY Ex - FX VPY Nexplanon ® (contraception) 220 165 33% 34% NuvaRing ® (contraception) 38 49 (22)% (19)% Marvelon Œ / Mercilon Œ (contraception) 33 37 (12)% (10)% Follistim AQ ® (fertility) 46 55 (17)% (15)% Ganirelix Acetate Injection (fertility) 29 30 (2)% — % Jada ® (device) 13 7 84% 84% Other Women's Health products 43 38 15% 16% Total Women's Health 422 381 11% 12% 8 • Nexplanon up 34% ex - FX driven by favorable comparison to buy - out in Q1 2023; volume and price growth • Fertility down 2%, following strong Q4, expect high single - digit growth in fertility for full year 2024 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 .
Biosimilars Biosimilars Revenues $ mil Q1 - 24 Q1 - 23 Act VPY Ex - FX VPY Renflexis ® 69 62 12% 12% Ontruzant ® 39 21 86% 86% Brenzys Œ 24 19 25% 26% Aybintio Œ 8 10 (20)% (21)% Hadlima ® 30 5 NM NM Biosimilars 170 116 46% 46% 9 • Ontruzant benefited from incremental tender demand in Brazil • Hadlima uptake continues following U.S. launch 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 Q1 - 24 Q1 - 23 Act VPY Ex - FX VPY Cardiovascular 365 384 (5)% (3)% Respiratory 277 292 (5)% (2)% Non - Opioid Pain, Bone & Derm 216 186 16% 19% Other 144 141 2% 4% Total Est. Brands 1,001 1,002 — % 2% 10 • Volume growth continues to outpace price pressure • New migraine assets and recovery of injectable steroids more than offset China VBP Totals may not foot due to rounding .
SG&A and R&D cost management significantly offset gross margin pressure All numbers presented on non - GAAP basis except revenue and IPR&D (1) Q1 - 24 Q1 - 23 Actual VPY Revenue 1,622 1,538 5% Cost of sales 615 535 15% Adjusted Gross profit 1,007 1,003 — % Selling, general and administrative 373 373 — % R&D 106 123 (14)% Acquired IPR&D and milestones 15 8 — Total research and development including IPR&D 121 131 (8)% Adjusted EBITDA 538 518 4% Adjusted diluted EPS 1.22 1.08 13% Per share impact to diluted EPS from acquired IPR&D and milestones (0.05) (0.03) — Adjusted Gross margin 62.1% 65.2% Adjusted EBITDA margin 33.2% 33.7% 11 (1) See Slides 19 - 21 of this presentation for a reconciliation of non - GAAP measures to their respective GAAP measures.
12 (USD millions) Q1 2024 Adjusted EBITDA $538 Less: Net cash interest expense (65) Less: Cash taxes (50) Less: Change in net working capital (291) Less: CapEx (23) Free Cash Flow Before One Time Costs $109 Less: One time spin - related costs (OpEx,CapEx) (68) Less: Other one - time costs (1) (OpEx) (36) Free Cash Flow (2) $6 Net working capital driven by: • Accrual drawdown for employee related incentive payments • Typical 1H increase in cash - cycle working capital consistent with prior years Q1 free cash flow in line with historical performance > 70% of annual free cash flow expected in 2H'24 (1) Includes operating expenses associated with restructuring initiatives and the planned exits from supply agreements with M erc k. (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 March 2024* Leverage ratio stable with 2023 year - end $ mil Dec 2021 Dec 2022 Dec 2023 Mar 2024 Cash and cash equivalents 737 706 693 575 Gross Debt (1) 9,134 8,913 8,760 8,714 Net Debt (1) 8,397 8,207 8,067 8,139 (*) The definition of net debt is in the company's credit agreement and excludes unamortized fees; but includes capitalized l eas e obligations. Additionally, the LTM EBITDA calculation excludes acquired IPR&D and milestone charges. (1) Debt figures are net of discounts and unamortized fees of $124 million, $105 million, $84 million and $79 million as of D ece mber 31, 2021, December 31, 2022, December 31, 2023 and March 31, 2024 respectively.
2024 expected to be third consecutive year of revenue growth at constant currency $ mil 14 (1) LOE = Loss of Exclusivity (2) VBP = Value Based Pricing (3) Other includes manufacturing sales to Merck and other third parties (1) (2) (3) (1.0%) to +3.8% reported, +1.1% to +5.7% growth at constant currency ~(160) - (220) bps headwind to growth in 2024 ~ ~ ~ ~ ~ ~ $6,200 - $6,500 No change to full year 2024 guidance ranges 15 Provided on a non - GAAP basis, except revenue Prior guidance Current guidance Revenues $6.2B - $6.5B Unchanged Adjusted gross margin 61.0% - 63.0% Unchanged SG&A $1.5B - $1.7B Unchanged R&D* $400M - $500M Unchanged Adjusted EBITDA margin (Non - GAAP) 31.0% - 33.0% Unchanged Interest ~$520M Unchanged Depreciation ~$130M Unchanged Effective non - GAAP tax rate 18.5% - 20.5% Unchanged Fully diluted weighted average shares outstanding ~259M Unchanged *R&D expense includes $15 million of IPR&D and milestone expense year - to - date March 31, 2024. R&D guidance does not take into co nsideration a forward looking view of IPR&D and milestone expense.
Q&A
Appendix
Franchise performance $ mil Q1 - 2024 Q1 - 2023 Actual VPY Ex - FX VPY Women’s Health 422 381 11% 12% Biosimilars 170 116 46% 46% Est. Brands 1,001 1,002 — % 2% Other (1) 29 39 (27)% (29)% Total Revenues 1,622 1,538 5% 7% (1) Other includes manufacturing sales to third parties. 18 Reconciliation of GAAP Reported to Non - GAAP Adjusted Information 19 Three Months Ended March 31, 2024 Unaudited, $ in millions except per share amounts GAAP Spin related Costs (1) Manufacturing Network Related Costs (2) Restructuring Stock - based Compensation Amortization Other Non - GAAP Adjusted Cost of sales $ 665 (3) (10) — (4) (33) — $ 615 Gross profit 957 3 10 — 4 33 — 1,007 Gross margin 59.0 % 62.1 % Selling, general and administrative 431 (40) — — (18) — — 373 Research and development 112 (2) — — (4) — — 106 Restructuring costs 23 — — (23) — — — — Other expense (income), net 3 (4) — — — — — (1) Taxes on income (3) 35 9 2 6 4 6 — 62 Net income 201 40 8 17 22 27 — 315 Earnings per share - Diluted $ 0.78 $ 1.22 (1) Spin - related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. ( 2 ) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co . , Inc . , Rahway NJ, US . (3) Represents the estimated tax impacts on the reconciling items by applying the statutory rate and applicable law of the or igi nating territory of the non - GAAP adjustments.
Reconciliation of GAAP Reported to Non - GAAP Adjusted Information 20 Three Months Ended March 31, 2023 Unaudited, $ in millions except per share amounts GAAP Spin related Costs (1) Restructuring Stock - based Compensation Amortization Other (2) Non - GAAP Adjusted Cost of sales $ 580 (10) — (4) (29) (2) $ 535 Gross profit 958 10 — 4 29 2 1,003 Gross margin 62.3 % 65.2 % Selling, general and administrative 435 (46) — (15) — (1) 373 Research and development 129 (3) — (3) — — 123 Restructuring costs 4 — (4) — — — — Other expense (income), net 6 (6) — — — — — Taxes on income (3) 58 13 1 4 6 — 82 Net income 177 52 3 18 23 3 276 Earnings per share - Diluted $ 0.69 $ 1.08 (1) Spin - related costs includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US. ( 2 ) Other costs primarily includes one - time costs related to inventory step - up adjustments and legal reserves . (3) Represents the estimated tax impacts on the reconciling items by applying the statutory rate and applicable law of the or igi nating territory of the non - GAAP adjustments.
GAAP Net Income to Adjusted EBITDA Unaudited, $ in millions Q1 - 2024 Q1 - 2023 Net Income 201 177 Depreciation (1) 30 28 Amortization 33 29 Interest expense 131 132 Taxes on income 35 58 EBITDA 430 424 Restructuring costs 23 4 One - time costs (2) 59 68 Stock - based compensation 26 22 Adjusted EBITDA (Non - GAAP) 538 518 Adjusted EBITDA margin (Non - GAAP) 33.2 % 33.7 % 21 ( 1 ) Excludes accelerated depreciation included in one - time costs . ( 2 ) Represents spin - related, manufacturing network, and other one - time costs . 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, $ 21 million and $ 37 million for the three months ended March 31 , 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 $ 14 million and $ 6 million for the three months ended March 31 , 2024 and 2023 , respectively, associated with temporary transition service agreements with Merck & Co . , Rahway, NJ . Manufacturing network related costs, including exiting of temporary manufacturing and supply agreements with Merck & Co . , Rahway, NJ, US, reflect accelerated depreciation, exit premiums, technology transfer costs, stability and qualification batch costs, and third - party contractor costs, and totaled $ 10 million for the three months ended March 31 , 2024 . As these costs 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