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): February 16, 2023
Organon & Co.
(Exact name of registrant as specified in its charter)
Delaware | 001-40235 | 46-4838035 | ||
(State or other jurisdiction | (Commission | (I.R.S. Employer | ||
of incorporation) | File Number) | Identification No.) | ||
30 Hudson Street, Floor 33, Jersey City, NJ |
07302 | |||
(Address of 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 February 16, 2023, Organon & Co. (the “Company”) issued a press release (the “Earnings Release”) regarding its results for the quarter and full year ended December 31, 2022. 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 February 16, 2023, the Company made available the Company Information Presentation relating to its financial results for the quarter and full year ended December 31, 2022. 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 February 16, 2023, 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: February 16, 2023
Exhibit 99.1
Media Contacts: | Karissa Peer | Investor Contacts: | Jennifer Halchak |
(614) 314-8094 | (201) 275-2711 | ||
Kate Vossen | Alex Arzeno | ||
(732) 675-8448 | (203) 550-3972 |
Organon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2022
· | Full year 2022 revenues of $6.2 billion; all three franchises contribute to growth on constant currency basis |
· | Full year 2022 diluted earnings per share from continuing operations of $3.59 and non-GAAP Adjusted diluted earnings per share from continuing operations of $5.03 |
· | Full year 2022 Adjusted EBITDA of $2.1 billion |
· | Full year 2023 financial guidance provided; full year revenue range of $6.150 billion to $6.450 billion and Adjusted EBITDA margin in the range of 31%-33% |
Jersey City, N.J., February 16, 2023 – Organon (NYSE: OGN) today announced its results for the fourth quarter and full year ended December 31, 2022.
"We enter 2023 with momentum, building off the significant achievements in our short history as an independent company", said Kevin Ali, Organon's CEO. "Since these products have been in our hands, we have set three quarterly sales records for Nexplanon, delivered two consecutive years of double-digit revenue growth in Biosimilars and demonstrated the durability of the Established Brands franchise. We have also continued to position the company for future growth with active business development - adding seven assets in Women's Health and a second partner in Biosimilars. We remain committed to continuing to deliver on the promise of our portfolio and advancing the innovation needed to improve women’s health."
Fourth Quarter 2022 revenues
in $ millions | Q4 2022 | Q4 2021 | VPY | VPY ex-FX | ||||||||||||
Women’s Health | $ | 433 | $ | 415 | 4 | % | 9 | % | ||||||||
Biosimilars | 134 | 118 | 13 | % | 17 | % | ||||||||||
Established Brands | 888 | 1,037 | (14 | )% | (4 | )% | ||||||||||
Other (1) | 30 | 34 | (8 | )% | (9 | )% | ||||||||||
Revenues | $ | 1,485 | $ | 1,604 | (7 | )% | 1 | % |
(1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties.
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For the fourth quarter of 2022, total revenue was $1,485 million, a decrease of 7% as-reported and an increase of 1% excluding the impact of foreign currency (ex-FX), compared with the fourth quarter of 2021.
Women’s Health revenue increased 4% as-reported, and 9% ex-FX in the fourth quarter of 2022 compared with the fourth quarter of 2021, driven primarily by Nexplanon® (etonogestrel implant) a long-acting reversible contraceptive, which grew 8% ex-FX in the fourth quarter of 2022 compared with the fourth quarter of 2021. The Women's Health franchise also benefited from 4% ex-FX growth in the fertility portfolio during the quarter, as well as from contributions from recent business development activity including combined oral contraceptives Marvelon™ (ethinylestradiol, desogestrel) and Mercilon™ (ethinylestradiol, desogestrel) which together grew 25% ex-FX in the fourth quarter of 2022. Growth in the Women's Health franchise was partially offset by a 5% ex-FX decrease of NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) which continues to be impacted by generic competition.
Biosimilars revenue increased 13% as-reported and 17% ex-FX in the fourth quarter 2022, compared with the fourth quarter of 2021 primarily driven by double-digit growth from Renflexis® (infliximab-abda), Ontruzant® (trastuzumab-dttb), Hadlima™ (adalimumab-bwwd) and Aybintio™ (bevacizumab). This was offset by a 13% ex-FX decline in Brenzys™ (etanercept) due to the timing of a tender in Brazil.
Established Brands revenue decreased 14% as-reported and 4% ex-FX in the fourth quarter of 2022, compared with the fourth quarter of 2021. The year over year decline in the fourth quarter was primarily related to the November 2022 inclusion of EzetrolTM (ezetimibe) in the seventh round of VBP (Volume Based Procurement) in China. Additionally, In January 2023, Organon initiated a market action in certain markets for betamethasone suspension injections sold under the trademarks DiprospanTM, Celestone Chronodose TM, and Celestone Soluspan®, related to a non-conforming component of a manufacturing line at Organon’s Heist, Belgium facility. This action resulted in a reduction of Established Brands revenue of $8 million in the fourth quarter of 2022. No product quality complaints have been reported, and there have been no reported adverse events attributable to the potentially impacted and distributed product batches.
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Fourth Quarter 2022 Profitability
in $ millions, except per share amounts | Q4 2022 | Q4 2021 | VPY | |||||||||
Revenues | $ | 1,485 | $ | 1,604 | (7 | )% | ||||||
Gross profit | 891 | 1,005 | (11 | )% | ||||||||
Non-GAAP Adjusted Gross Profit (1) | 937 | 1,059 | (12 | )% | ||||||||
Adjusted EBITDA (1,2) | 380 | 470 | (19 | )% | ||||||||
Net Income, continuing operations | 108 | 202 | (47 | )% | ||||||||
Non-GAAP adjusted net income, continuing operations (1) | 208 | 287 | (28 | )% | ||||||||
Diluted Earnings per Share (EPS), continuing operations | 0.42 | 0.79 | (47 | )% | ||||||||
Non-GAAP adjusted diluted EPS, continuing operations (1) | 0.81 | 1.13 | (28 | )% | ||||||||
Acquired IPR&D (in-process research and development) and milestones | — | 79 | NM | |||||||||
Per share impact to diluted EPS from acquired IPR&D and milestones | — | (0.24 | ) | NM | ||||||||
Q4 2022 | Q4 2021 | |||||||||||
Gross margin | 60.0 | % | 62.7 | % | ||||||||
Non-GAAP Adjusted Gross Margin (1) | 63.1 | % | 66.0 | % | ||||||||
Adjusted EBITDA margin (1,2) | 25.6 | % | 29.3 | % |
(1) | See Tables 4,5 and 6 for reconciliations of GAAP to non-GAAP financial measures |
(2) | Adjusted EBITDA and Adjusted EBITDA margin include no acquired IPR&D in the fourth quarter of 2022 , and $79 million in the fourth quarter of 2021 related to acquired IPR&D and milestones |
Gross margin in the fourth quarter of 2022 was 60.0% as-reported, compared with 62.7% in the prior year period. Adjusted Gross Margin was 63.1% in the fourth quarter of 2022 compared with 66.0% on an adjusted basis in the fourth quarter of 2021. The year over year decline in gross margin is primarily due to inventory charges of $36 million recognized in Cost of sales and an $8 million sales return reserve related to the market action associated with the Heist plant.
Adjusted EBITDA margin was 25.6% in the fourth quarter of 2022 compared with 29.3% in the fourth quarter of 2021. Together with the costs associated with the market action at Heist, expenses related to positioning the company for future growth - higher selling and promotional costs as well as research and development spend associated with the company's prior acquisitions - contributed to the decline in Adjusted EBITDA margin in the fourth quarter.
Net income from continuing operations for the fourth quarter of 2022 was $108 million, or $0.42 per diluted share, compared with $202 million, or $0.79 per diluted share, in the fourth quarter of 2021. Non-GAAP Adjusted net income from continuing operations was $208 million, or $0.81 per diluted share, compared with $287 million, or $1.13 per diluted share, in 2021.
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2022 Revenues
in $ millions | FY 2022 | FY 2021 | VPY | VPY ex-FX | ||||||||||||
Women’s Health | $ | 1,673 | $ | 1,612 | 4 | % | 7 | % | ||||||||
Biosimilars | 481 | 424 | 13 | % | 17 | % | ||||||||||
Established Brands | 3,874 | 4,068 | (5 | )% | 3 | % | ||||||||||
Other(1) | 146 | 200 | (27 | )% | (29 | )% | ||||||||||
Revenue | $ | 6,174 | $ | 6,304 | (2 | )% | 4 | % |
(1) | Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA, and other third parties, and allocated amounts from pre-spin revenue hedging activities through the date of separation. |
Total revenue was $6.2 billion for full year 2022, a decrease of 2% as-reported and an increase of 4% ex-FX, compared with the full year 2021. With approximately 75% of the company's revenue outside of the United States, foreign exchange translation represented an approximate 600 bps headwind to total revenue in 2022. On a constant currency basis, all three of the company's franchises grew for the full year 2022.
Women’s Health revenue increased 4% as-reported and 7% ex-FX for full year 2022 compared with 2021, driven by Nexplanon which increased 11% ex-FX. Nexplanon's growth was primarily due to demand uptake and favorable pricing in the United States, as well as volume growth in the company's LAMERA region (Latin America, Middle-East, Russia and Africa). Additionally, within Women's Health, the fertility portfolio grew approximately 9% ex-FX for the full year 2022, and the reacquisition of rights to Marvelon and Mercilon in certain Asian markets contributed about two points of constant currency growth to Women's Health in 2022. Performance was partially offset by a 6% ex-FX decline in NuvaRing for full year 2022.
Biosimilars revenue grew 13% as-reported and 17% ex-FX for full year 2022 compared with 2021, driven primarily by continued demand growth in the United States for Renflexis and Ontruzant as well as strong performance across the biosimilars portfolio in Canada. Hadlima was up 57% ex-FX in 2022, reflecting its successful 2021 launch in Canada and Australia.
Revenue for Established Brands declined 5% as-reported and increased 3% ex-FX for the full year 2022. In 2022, volume growth of greater than 6% more than offset mandated price decreases in certain markets. Full year performance benefited from a temporary supply issue that impacted several competitors in the Japanese market as well as from strong performance in Atozet ™ (ezetimibe and atorvastatin), and the respiratory portfolio. Still, with loss of exclusivity risk largely behind the portfolio, together with continued focus on maximizing the potential of these well-known brands, Organon expects the Established Brands franchise to achieve flat performance in 2023 at constant currency.
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Full Year 2022 Profitability
in $ millions, except per share amounts | 2022 | 2021 | VPY | |||||||||
Revenues | $ | 6,174 | $ | 6,304 | (2 | )% | ||||||
Cost of sales | 2,294 | 2,382 | (4 | )% | ||||||||
Gross profit | 3,880 | 3,922 | (1 | )% | ||||||||
Non-GAAP Adjusted Gross Profit (1) | 4,058 | 4,081 | (1 | )% | ||||||||
Adjusted EBITDA (1,2) | 2,085 | 2,275 | (8 | )% | ||||||||
Net Income, continuing operations | 917 | 1,351 | (32 | )% | ||||||||
Non-GAAP adjusted net income, continuing operations (1) | 1,284 | 1,577 | (19 | )% | ||||||||
Diluted Earnings per Share (EPS), continuing operations | 3.59 | 5.31 | (32 | )% | ||||||||
Non-GAAP adjusted diluted EPS, continuing operations (1) | 5.03 | 6.20 | (19 | )% | ||||||||
Acquired in-process research & development (IPR&D) and milestones | 107 | 104 | 3 | % | ||||||||
Per share impact to diluted EPS from acquired IPR&D and milestones | (0.33 | ) | (0.33 | ) | NM | |||||||
2022 | 2021 | |||||||||||
Gross margin | 62.8 | % | 62.2 | % | ||||||||
Non-GAAP Adjusted Gross Margin (1) | 65.7 | % | 64.7 | % | ||||||||
Adjusted EBITDA margin (1,2) | 33.8 | % | 36.1 | % |
(1) | See Tables 4,5 and 6 for reconciliations of GAAP to non-GAAP financial measures |
(2) | Adjusted EBITDA and Adjusted EBITDA margin include $107 million in 2022 and $104 million in 2021 related to acquired IPR&D and milestones |
Gross margin was 62.8% as-reported and 65.7% on an adjusted basis for full year 2022 compared with 62.2% as-reported and 64.7% on an adjusted basis in 2021. The year-over-year increase in Adjusted Gross Margin reflects the impact of lower supply sales (which carry lower margins) compared with the prior year, pre-spin allocated costs related to the separation in the prior year and a $24 million charge pertaining to unavoidable losses associated with a long-term vendor supply contract also incurred during the prior year, offset by the aforementioned inventory charges of $36 million recognized in Cost of sales in the fourth quarter of 2022 relating to the company’s market action.
Adjusted EBITDA margin was 33.8% for the full year 2022 compared with 36.1% for the full year 2021. Together with the costs associated with the market action at Heist, expenses related to positioning the company for future growth - higher selling and promotional costs as well as continued R&D spend associated with the company's recent acquisitions of clinical stage assets - contributed to the decline in Adjusted EBITDA margin year over year.
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Net income from continuing operations for 2022 was $917 million, or $3.59 per diluted share, compared with $1.4 billion, or $5.31 per diluted share in 2021. Non-GAAP Adjusted net income from continuing operations was $1.3 billion, or $5.03 per diluted share, compared with $1.6 billion, or $6.20 per diluted share in 2021.
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 March 16, 2023 to stockholders of record at the close of business on February 27, 2023.
As of December 31, 2022, cash and cash equivalents were $706 million, and debt was $8.9 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.
The company is presenting its 2023 financial guidance ranges below.
2023 Full Year guidance | ||
Revenues | $6.150 billion - $6.450 billion | |
Adjusted Gross Margin | Low-mid 60% range | |
SG&A (as % of revenue) | Mid 20% range | |
R&D1 (as % of revenue) | Upper single-digit | |
Adjusted EBITDA Margin | 31.0%-33.0% | |
Interest | ~$510 million | |
Depreciation | ~$130 million | |
Effective Non-GAAP Tax Rate | 19.0% - 21.0% | |
Fully Diluted Weighted Average Shares Outstanding | ~$255 million |
1 | The range provided for estimated R&D spend includes the company's estimate of approximately $40 million for IPR&D for the full year 2023 which is based on estimated milestones that may be achieved in 2023 by products in the company's current portfolio. Organon's financial guidance does not assume an estimate for future IPR&D for business development transactions not yet executed. |
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Webcast Information
Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its fourth quarter and full year 2022 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://conferencingportals.com/event/ZGyfDfjk
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 with a focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in innovation and future growth opportunities in women’s health. 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, Twitter and Facebook.
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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 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 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. You should refer to the appendix of this press release for 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 2023 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 and other items not reflective of the company's ongoing operations.
The company uses non-GAAP financial measures in its operational and financial decision making, and believes that it is useful to exclude certain items in order to focus on what it regards to be a more meaningful representation of the underlying operating performance of the business.
Cautionary Note Regarding Forward-Looking Statements
Except for historical information herein, 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. Forward-looking statements may be identified by words such as “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.
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Risks and uncertainties include, but are not limited to, 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; general economic factors, including recessionary pressures, interest rate and currency exchange rate fluctuations; general industry conditions and competition; the impact of the ongoing COVID-19 pandemic and emergence of variant strains; 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; 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 Annual Report on Form 10-K for the year ended December 31, 2022, available at the SEC’s Internet site (www.sec.gov).
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TABLE 1
Organon & Co.
Condensed Consolidated Statement of Income
(Unaudited, $ in millions except shares in thousands and per share amounts)
Three Months Ended December 31, |
Year Ended December 31, |
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2022 | 2021 | 2022 | 2021 | |||||||||||||
Revenues | $ | 1,485 | $ | 1,604 | $ | 6,174 | $ | 6,304 | ||||||||
Costs, Expenses and Other | ||||||||||||||||
Cost of sales | 594 | 599 | 2,294 | 2,382 | ||||||||||||
Selling, general and administrative | 470 | 481 | 1,704 | 1,668 | ||||||||||||
Research and development | 142 | 110 | 471 | 339 | ||||||||||||
Acquired in-process research and development and milestones | — | 79 | 107 | 104 | ||||||||||||
Restructuring costs | 17 | — | 28 | 3 | ||||||||||||
Interest expense | 119 | 98 | 422 | 258 | ||||||||||||
Exchange losses (gains) | 32 | (2 | ) | 11 | 4 | |||||||||||
Other expense, net | — | 3 | 15 | 17 | ||||||||||||
1,374 | 1,368 | 5,052 | 4,775 | |||||||||||||
Income From Continuing Operations Before Income Taxes | 111 | 236 | 1,122 | 1,529 | ||||||||||||
Taxes on Income | 3 | 34 | 205 | 178 | ||||||||||||
Net Income From Continuing Operations | 108 | 202 | 917 | 1,351 | ||||||||||||
Loss From Discontinued Operations - Net of Tax | — | — | — | — | ||||||||||||
Net Income | 108 | 202 | 917 | 1,351 | ||||||||||||
Earnings per Share - Basic: | ||||||||||||||||
Continuing operations | $ | 0.42 | $ | 0.80 | $ | 3.61 | $ | 5.33 | ||||||||
Discontinued operations | — | — | — | — | ||||||||||||
Net Earnings per Share - Basic | $ | 0.42 | $ | 0.80 | $ | 3.61 | $ | 5.33 | ||||||||
Earnings per Share - Diluted: | ||||||||||||||||
Continuing operations | $ | 0.42 | $ | 0.79 | $ | 3.59 | $ | 5.31 | ||||||||
Discontinued operations | — | — | — | — | ||||||||||||
Net Earnings per Share - Diluted | $ | 0.42 | $ | 0.79 | $ | 3.59 | $ | 5.31 | ||||||||
Weighted Average Shares Outstanding: | ||||||||||||||||
Basic | 254,367 | 253,549 | 254,082 | 253,538 | ||||||||||||
Diluted | 255,390 | 254,551 | 255,169 | 254,193 |
TABLE 2
Organon & Co.
Sales by top products
Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||||||||||||||||
($ in millions) | U.S. | Int’l | Total | U.S. | Int’l | Total | U.S. | Int’l | Total | U.S. | Int’l | Total | |||||||||||||||||||||||||
Women’s Health | |||||||||||||||||||||||||||||||||||||
Nexplanon/Implanon NXT | $ | 172 | $ | 67 | $ | 239 | $ | 143 | $ | 83 | $ | 226 | $ | 573 | $ | 261 | $ | 834 | $ | 532 | $ | 237 | $ | 769 | |||||||||||||
Follistim AQ | 26 | 25 | 50 | 29 | 30 | 59 | 105 | 124 | 229 | 110 | 127 | 237 | |||||||||||||||||||||||||
NuvaRing | 21 | 20 | 40 | 18 | 27 | 44 | 85 | 88 | 173 | 85 | 106 | 191 | |||||||||||||||||||||||||
Ganirelix Acetate Injection | 6 | 20 | 25 | 3 | 22 | 26 | 26 | 97 | 123 | 22 | 88 | 111 | |||||||||||||||||||||||||
Marvelon/Mercilon | — | 24 | 24 | — | 22 | 22 | — | 110 | 110 | — | 98 | 98 | |||||||||||||||||||||||||
Other Women's Health (1) | 30 | 24 | 54 | 14 | 25 | 38 | 110 | 94 | 204 | 96 | 111 | 206 | |||||||||||||||||||||||||
Biosimilars | |||||||||||||||||||||||||||||||||||||
Renflexis | 51 | 9 | 60 | 46 | 5 | 51 | 196 | 30 | 226 | 164 | 21 | 186 | |||||||||||||||||||||||||
Ontruzant | 13 | 22 | 35 | 14 | 11 | 26 | 48 | 74 | 122 | 34 | 92 | 126 | |||||||||||||||||||||||||
Brenzys | — | 23 | 23 | — | 28 | 28 | — | 75 | 75 | — | 63 | 63 | |||||||||||||||||||||||||
Aybintio | — | 10 | 10 | — | 10 | 10 | — | 39 | 39 | — | 36 | 36 | |||||||||||||||||||||||||
Hadlima | — | 6 | 6 | — | 4 | 4 | — | 19 | 19 | — | 13 | 13 | |||||||||||||||||||||||||
Established Brands | |||||||||||||||||||||||||||||||||||||
Cardiovascular | |||||||||||||||||||||||||||||||||||||
Zetia | 1 | 70 | 71 | 4 | 92 | 96 | 8 | 350 | 357 | 10 | 368 | 378 | |||||||||||||||||||||||||
Vytorin | 1 | 25 | 26 | 3 | 34 | 37 | 8 | 123 | 130 | 11 | 153 | 164 | |||||||||||||||||||||||||
Atozet | — | 107 | 107 | — | 110 | 110 | — | 457 | 457 | — | 458 | 458 | |||||||||||||||||||||||||
Rosuzet | — | 16 | 16 | — | 19 | 19 | — | 71 | 71 | — | 68 | 68 | |||||||||||||||||||||||||
Cozaar/Hyzaar | 2 | 66 | 68 | 3 | 90 | 93 | 13 | 310 | 323 | 12 | 345 | 357 | |||||||||||||||||||||||||
Other Cardiovascular (1) | 1 | 39 | 40 | 1 | 41 | 42 | 3 | 156 | 159 | 4 | 187 | 191 | |||||||||||||||||||||||||
Respiratory | |||||||||||||||||||||||||||||||||||||
Singulair | 3 | 92 | 95 | 5 | 108 | 113 | 11 | 400 | 411 | 15 | 398 | 413 | |||||||||||||||||||||||||
Nasonex | — | 56 | 56 | 2 | 61 | 62 | 10 | 229 | 238 | 4 | 201 | 206 | |||||||||||||||||||||||||
Dulera | 42 | 10 | 52 | 34 | 10 | 44 | 140 | 40 | 180 | 154 | 36 | 190 | |||||||||||||||||||||||||
Clarinex | 2 | 25 | 27 | 1 | 27 | 28 | 4 | 121 | 125 | 6 | 106 | 111 | |||||||||||||||||||||||||
Other Respiratory (1) | 12 | 5 | 17 | 13 | 12 | 25 | 46 | 36 | 83 | 56 | 33 | 89 | |||||||||||||||||||||||||
Non-Opioid Pain, Bone and | |||||||||||||||||||||||||||||||||||||
Arcoxia | — | 56 | 56 | — | 60 | 60 | — | 241 | 241 | — | 244 | 244 | |||||||||||||||||||||||||
Fosamax | 2 | 34 | 36 | 1 | 42 | 43 | 4 | 148 | 152 | 4 | 172 | 175 | |||||||||||||||||||||||||
Diprospan | — | 31 | 31 | — | 33 | 33 | — | 122 | 122 | — | 125 | 125 | |||||||||||||||||||||||||
Other Non-Opioid Pain, Bone and Dermatology (1) | 5 | 56 | 62 | 4 | 68 | 72 | 15 | 257 | 273 | 16 | 269 | 286 | |||||||||||||||||||||||||
Other | |||||||||||||||||||||||||||||||||||||
Proscar | — | 23 | 24 | — | 25 | 26 | 1 | 99 | 101 | 1 | 116 | 117 | |||||||||||||||||||||||||
Propecia | 2 | 28 | 30 | 4 | 31 | 36 | 7 | 118 | 125 | 9 | 127 | 136 | |||||||||||||||||||||||||
Other (1) | 3 | 72 | 75 | 8 | 89 | 97 | 24 | 302 | 326 | 41 | 318 | 360 | |||||||||||||||||||||||||
Other (2) | (1 | ) | 30 | 30 | (3 | ) | 38 | 34 | — | 146 | 146 | (3 | ) | 205 | 200 | ||||||||||||||||||||||
Revenues | $ | 394 | $ | 1,091 | $ | 1,485 | $ | 347 | $ | 1,257 | $ | 1,604 | $ | 1,437 | $ | 4,737 | $ | 6,174 | $ | 1,383 | $ | 4,921 | $ | 6,304 |
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) | Includes sales of products not listed separately. Revenues from Marvelon/Mercilon 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. |
(2) | Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties, and allocated amounts from pre-spin revenue hedging activities. |
TABLE 3
Organon & Co.
Sales by geographic area
(Unaudited, $ in millions)
Three Months Ended December 31, |
Year Ended December 31, |
|||||||||||||||
($ in millions) | 2022 | 2021 | 2022 | 2021 | ||||||||||||
Europe and Canada | $ | 389 | $ | 427 | $ | 1,631 | $ | 1,741 | ||||||||
United States | 394 | 347 | 1,437 | 1,383 | ||||||||||||
Asia Pacific and Japan | 256 | 299 | 1,143 | 1,173 | ||||||||||||
China | 196 | 240 | 917 | 933 | ||||||||||||
Latin America, Middle East, Russia and Africa | 230 | 246 | 895 | 841 | ||||||||||||
Other (1) | 20 | 45 | 151 | 233 | ||||||||||||
Revenues | $ | 1,485 | $ | 1,604 | $ | 6,174 | $ | 6,304 |
(1) | Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties, and allocated amounts from pre-spin revenue hedging activities. |
TABLE 4
Reconciliation of GAAP Gross Margin to Non-GAAP Adjusted Gross Profit and Adjusted Gross Margin
($ in millions)
Three Months Ended December 31, |
Year Ended December 31, |
|||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Revenues | $ | 1,485 | $ | 1,604 | $ | 6,174 | $ | 6,304 | ||||||||
Cost of sales | 594 | 599 | 2,294 | 2,382 | ||||||||||||
Gross Profit | 891 | 1,005 | 3,880 | 3,922 | ||||||||||||
Gross Margin | 60.0 | % | 62.7 | % | 62.8 | % | 62.2 | % | ||||||||
Amortization | 28 | 34 | 116 | 103 | ||||||||||||
One-time costs (1) | 14 | 17 | 49 | 45 | ||||||||||||
Stock-based compensation | 4 | 3 | 13 | 11 | ||||||||||||
Non-GAAP Adjusted Gross Profit (2) | $ | 937 | $ | 1,059 | 4,058 | 4,081 | ||||||||||
Non-GAAP Adjusted Gross Margin | 63.1 | % | 66.0 | % | 65.7 | % | 64.7 | % |
(1) One-time costs for the three months ended December 31, 2022 primarily include costs to stand up the company and inventory step-up adjustments. One-time costs for the year ended December 31, 2022 primarily include costs to stand up the company and inventory step-up adjustments as well as a $9 million impairment charge related to a licensed intangible asset.
One-time costs for the three months ended December 31, 2021 include costs to stand up the Company as well as a $7 million impairment charge relating to a licensed intangible asset. For the year ended December 31, 2021, one-time costs include inventory discards related to separation re-labeling and other costs to stand up the Company as well as a $7 million impairment charge related to a licensed intangible asset.
(2) Non-GAAP Adjusted Gross Profit is calculated by excluding amortization, one-time costs, and the portion of stock-based compensation expense allocated to Cost of sales.
TABLE 5
Organon & Co.
Reconciliation of GAAP Income from Continuing Operations Before Income Taxes to Adjusted EBITDA
($ in millions)
Three Months Ended December 31, |
Year Ended December 31, |
|||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Income from continuing operations before income taxes | $ | 111 | $ | 236 | $ | 1,122 | $ | 1,529 | ||||||||
Depreciation | 24 | 28 | 96 | 92 | ||||||||||||
Amortization (1) | 28 | 34 | 116 | 103 | ||||||||||||
Interest expense | 119 | 98 | 422 | 258 | ||||||||||||
EBITDA | $ | 282 | $ | 396 | $ | 1,756 | $ | 1,982 | ||||||||
Restructuring costs | 17 | — | 28 | 3 | ||||||||||||
One-time costs (2) | 58 | 59 | 226 | 231 | ||||||||||||
Stock-based compensation (3) | 23 | 15 | 75 | 59 | ||||||||||||
Adjusted EBITDA | $ | 380 | $ | 470 | $ | 2,085 | $ | 2,275 | ||||||||
Adjusted EBITDA margin | 25.6 | % | 29.3 | % | 33.8 | % | 36.1 | % |
(1) Amortization in all periods is included in Cost of sales.
(2) One-time costs primarily include costs incurred in connection with the spin-off of Organon, inventory step up adjustments and legal reserves. For the three months ended December 31, 2022, $41 million of the one-time costs are recorded in Selling, general and administrative expenses, $14 million are recorded in Cost of sales and $3 million are recorded in Research and development. For the three months ended December 31, 2021, $26 million of the one-time costs are recorded in Selling, general and administrative expenses, $17 million are recorded in Cost of sales, $9 million are recorded in Research and development, and $7 million in Other (income) expense.
(2) One-time costs primarily include costs incurred in connection with the spin-off of Organon, an impairment of a licensed intangible asset, inventory step-up adjustments and legal reserves. For the year ended December 31, 2022, $143 million of the one-time costs are recorded in Selling, general and administrative expenses, $49 million are recorded in Cost of sales, $19 million are recorded in Other (income) expense, and $15 million are recorded in Research and development. For the year ended December 31, 2021, $165 million of the one-time costs are recorded in Selling, general and administrative expenses (which includes $23 million pertaining to the acquisition of Alydia in the second quarter 2021), $45 million are recorded in Cost of sales, $14 million are recorded in Research and development, and $7 million are recorded in Other (income) expense.
(3) For the three months ended December 31, 2022, approximately $4 million of stock-based compensation is recorded in Cost of sales, $16 million is recorded in Selling, general and administrative and $3 million is recorded in Research and development. For the three months ended December 31, 2021, approximately $3 million of stock-based compensation is recorded in Cost of sales, $10 million is recorded in Selling, general and administrative and $2 million is recorded in Research and development.
(3) For the year ended December 31, 2022, approximately $13 million of stock-based compensation is recorded in Cost of sales, $51 million is recorded in Selling, general and administrative and $11 million is recorded in Research and development. For the year ended December 31, 2021, approximately $11 million of stock-based compensation is recorded in Cost of sales, $36 million is recorded in Selling, general and administrative and $12 million is recorded in Research and development.
TABLE 6
Organon & Co.
Reconciliation of GAAP Income from Continuing Operations Before Income Taxes to Non-GAAP Adjusted Net Income
($ in millions, except per share amounts)
Three Months Ended December 31, |
Year Ended December 31, |
|||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Income from continuing operations before income taxes | $ | 111 | $ | 236 | $ | 1,122 | $ | 1,529 | ||||||||
Adjustments: | ||||||||||||||||
Amortization (1) | 28 | 34 | 116 | 103 | ||||||||||||
Restructuring costs | 17 | — | 28 | 3 | ||||||||||||
One-time costs (2) | 58 | 59 | 226 | 231 | ||||||||||||
Stock-based compensation (3) | 23 | 15 | 75 | 59 | ||||||||||||
Total Adjustments | 126 | 108 | 445 | 396 | ||||||||||||
Non-GAAP pre-tax income, continuing operations | $ | 237 | $ | 344 | $ | 1,567 | $ | 1,925 | ||||||||
Taxes on income as reported in accordance with GAAP | 3 | 34 | 205 | 178 | ||||||||||||
Tax benefit on adjustments | 23 | 18 | 78 | 74 | ||||||||||||
Tax benefit on GAAP-only discrete items (4) | 3 | 5 | — | 96 | ||||||||||||
Non-GAAP adjusted taxes on income | 29 | 57 | 283 | 348 | ||||||||||||
Non-GAAP adjusted net income, continuing operations | $ | 208 | $ | 287 | $ | 1,284 | $ | 1,577 | ||||||||
Non-GAAP adjusted net income, continuing operations per diluted share | $ | 0.81 | $ | 1.13 | $ | 5.03 | $ | 6.20 |
(1) Amortization in all periods is included in Cost of sales.
(2) One-time costs primarily include costs incurred in connection with the spin-off of Organon, inventory step up adjustments and legal reserves. For the three months ended December 31, 2022, $41 million of the one-time costs are recorded in Selling, general and administrative expenses, $14 million are recorded in Cost of sales and $3 million are recorded in Research and development. For the three months ended December 31, 2021, $26 million of the one-time costs are recorded in Selling, general and administrative expenses, $17 million are recorded in Cost of sales, $9 million are recorded in Research and development, and $7 million in Other (income) expense.
(2) One-time costs primarily include costs incurred in connection with the spin-off of Organon, an impairment of a licensed intangible asset, inventory step-up adjustments and legal reserves. For the year ended December 31, 2022, $143 million of the one-time costs are recorded in Selling, general and administrative expenses, $49 million are recorded in Cost of sales, $19 million are recorded in Other (income) expense, and $15 million are recorded in Research and development. For the year ended December 31, 2021, $165 million of the one-time costs are recorded in Selling, general and administrative expenses (which includes $23 million pertaining to the acquisition of Alydia in the second quarter 2021), $45 million are recorded in Cost of sales, $14 million are recorded in Research and development, and $7 million are recorded in Other (income) expense.
(3) For the three months ended December 31, 2022, approximately $4 million of stock-based compensation is recorded in Cost of sales, $16 million is recorded in Selling, general and administrative and $3 million is recorded in Research and development. For the three months ended December 31, 2021, approximately $3 million of stock-based compensation is recorded in Cost of sales, $10 million is recorded in Selling, general and administrative and $2 million is recorded in Research and development.
(3) For the year ended December 31, 2022, approximately $13 million of stock-based compensation is recorded in Cost of sales, $51 million is recorded in Selling, general and administrative and $11 million is recorded in Research and development. For the year ended December 31, 2021, approximately $11 million of stock-based compensation is recorded in Cost of sales, $36 million is recorded in Selling, general and administrative and $12 million is recorded in Research and development.
(4) For the three months and year ended December 31, 2021, the Company recorded a tax benefit of approximately $5 million and $75 million, respectively, related to a portion of non-US step up in tax basis as a result of its separation from Merck & Co., Inc., Rahway, NJ.
Exhibit 99.2
Fourth Quarter and Full Year 2022 Earnings Organon Disclaimer statement Cautionary Note Regarding Forward - Looking Statements Except for historical information herein, this presentation 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 ex pec tations about Organon’s future financial performance and prospects. Forward - looking statements may be identified by words such as “expects,” “ intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will” or words of similar meaning. These statements are based upon th e current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumption s p rove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward - looki ng statements. Risks and uncertainties include, but are not limited to, an inability to execute on our business development strategy or real ize the benefits of our planned acquisitions; efficacy, safety, or other quality concerns with respect to marketed products, including market actions su ch as recalls, withdrawals, or declining sales; general economic factors, including recessionary pressures, interest rate and currency excha nge rate fluctuations; general industry conditions and competition; the impact of the ongoing COVID - 19 pandemic and emergence of variant strains; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global tre nds toward health care cost containment; technological advances; new products and patents attained by competitors; challenges inherent in new p rod uct development, including obtaining regulatory approval; the company’s ability to accurately predict its future financial result s a nd performance; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; difficulties devel opi ng 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 o bli gation to publicly update any forward - looking statement, whether as a result of new information, future events or otherwise. Additional factors tha t could cause results to differ materially from those described in the forward - looking statements can be found in the company's filings with t he Securities and Exchange Commission (SEC), including the company's Annual Report on Form 10 - K for the year ended December 31, 2021 and subsequen t SEC filings, available at the SEC's internet site (www.sec.gov). 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 not excluded or included in the most directly comparable measures calculated and presented in accordance with U.S. generally acce pte d accounting principles (“GAAP”). Specifically, the company makes use of the non - GAAP financial measures Adjusted EBITDA, Adjusted Net Income, and Adjusted diluted EPS, which are not recognized terms under GAAP and are presented only as a supplement to the com pan y’s GAAP financial statements. This presentation also provides certain measures that exclude the impact of foreign exchange. We c alc ulate 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 analy tic al tool and should not be considered in isolation, or as a substitute for the company’s results as reported under GAAP. Because not all c omp anies use identical calculations, the presentations of these non - GAAP measures may not be comparable to other similarly titled measures of other companies. You should refer to the appendix of this presentation for relevant definitions and reconciliations of non - GAAP financ ial measures contained herein to the most directly comparable GAAP measures. In addition, the company’s full - year 2023 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, acquis iti on related expenses, restructuring and related expenses, stock - based compensation, and other items not reflective of the company's ongoing operations. The company uses non - GAAP financial measures in its operational and financial decision making, and believes that it is useful to exclude certain items in order to focus on what it regards to be a more meaningful representation of the underlying operating perform anc e of the business. 3 FY 2022 highlights 4 • Revenue of $6.2 billion, up 4% ex - FX • All three franchises contributed to growth, ex - FX • All geographies in positive territory in 2022 • Adjusted EBITDA of $2.1 billion • Diluted EPS of $3.59; Adjusted Diluted EPS of $5.03 See Slides 20 - 24 of this presentation for a reconciliation of non - GAAP measures.
Each franchise contributed to growth Women's Health Biosimilars Established Brands • Second consecutive year of double - digit growth in Nexplanon ex - FX • Fertility strong growth despite COVID impact in China • Executing on business development • Strong performance of Renflexis and Ontruzant in U.S.
• Added new biosimilar collaboration • Growth in Hadlima in Australia and Canada following successful launches in 2021 • Delivered 3% constant currency growth in 2022 • Growth in China despite COVID • Expect stabilization to continue , despite VBP impact in 2023 5 All geographies contributed to ex - FX growth $ mil 2022 2021 Actual VPY Ex - FX VPY Europe and Canada 1,631 1,741 (6)% 4% United States 1,437 1,383 4% 4% Asia Pacific and Japan 1,143 1,173 (3)% 10% China 917 933 (2)% 2% Latin America, Middle East, Russia and Africa 895 841 6% 9% Other (1) 151 233 (32)% (33)% Total Revenues 6,174 6,304 (2)% 4% 6 ~77% of 2022 sales generated ex - US (1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties, and allocated amounts f rom pre - spin revenue hedging activities.
[Organon] Confidential - 7% reported +1% ex - FX $ mil 7 Volume growth drives sales performance (3) (1) (2) ~0 ~(20) ~65 ~(15) ~(130) ~(15) $1,604 $1,485 FX ~ (800) bps headwind to growth in Q4 (1) LOE = Loss of Exclusivity (2) VBP = Volume Based Procurement (3) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties [Organon] Confidential $ mil 8 Volume growth drives performance; minimal LOE, VBP impact ~515 (3) $ 6,304 $6 , 174 ~(30) ~(20) ~(140) FX ~(600) bps headwind to growth for full year (1) LOE = Loss of Exclusivity (2) VBP = Volume Based Procurement (3) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties ~(70) ~(380) (1) (2) - 2% reported +4% ex - FX
Women’s Health Women’s Health Revenues $ mil Q4 - 22 Q4 - 21 Act VPY Ex - FX VPY 2022 2021 Act VPY Ex - FX VPY Top Contraception Products Nexplanon ® 239 226 6% 8% 834 769 8% 11% NuvaRing ® 40 44 (9)% (5)% 173 191 (9)% (6)% Marvelon Œ /Mercilon Œ 24 22 12% 25% 110 98 12% 20% Top Fertility Products Follistim ® 50 59 (15)% (11)% 229 237 (3)% — % Ganirelix Acetate Injection 25 26 (1)% 9% 123 111 11% 18% Other Women's Health products 54 38 43% 50% 204 206 (1)% 3% Total Women's Health 433 415 4% 9% 1,673 1,612 4% 7% 9 • Strong demand for Nexplanon • COVID in China impacted fertility in Q4 • Expanding breadth of franchise with business development 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 Q4 - 22 Q4 - 21 Act VPY Ex - FX VPY 2022 2021 Act VPY Ex - FX VPY Renflexis ® 60 51 19% 20% 226 186 21% 22% Ontruzant ® 35 26 36% 40% 122 126 (4)% — % Brenzys Œ 23 28 (17)% (13)% 75 63 19% 24% Aybintio Œ 10 10 (3)% 12% 39 36 7% 21% Hadlima Œ 6 4 51% 64% 19 13 51% 57% Biosimilars 134 118 13% 17% 481 424 13% 17% 10 • Renflexis still growing five years after launch • Strong US growth in Ontruzant offset by pricing pressure in EU • Demonstrating commitment with additional partnership 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 Q4 - 22 Q4 - 21 Act VPY Ex - FX VPY 2022 2021 Act VPY Ex - FX VPY Cardiovascular 328 398 (18)% (5)% 1,498 1,616 (7)% 2% Respiratory 247 273 (10)% (1)% 1,037 1,009 3% 10% Non - Opioid Pain, Bone & Dermatology 185 208 (11)% (3)% 788 830 (5)% 2% Other 128 158 (19)% (8)% 552 613 (10)% (2)% Total Est. Brands 888 1,037 (14)% (4)% 3,874 4,068 (5)% 3% 11 • Expect continued stable performance • Full - year performance aided by competitor supply interruptions and delayed VBP Totals may not foot due to rounding .
Ex - market action, Q4 results in - line with expectations Q4 - 2022 2022 Reported Impact of market action Reported Impact of market action Revenue 1,485 (8) 6,174 (8) Cost of sales 594 36 2,294 36 Gross profit 891 (44) 3,880 (44) Gross margin 60.0 % (260) bps 62.8 % (70) bps Non - GAAP Adjusted Gross Profit 937 (44) 4,058 (44) Non - GAAP Adjusted Gross Margin 63.1 % (260) bps 65.7 % (70) bps Adjusted EBITDA 380 (44) 2,085 (44) Adjusted EBITDA margin 25.6 % (280) bps 33.8 % (60) bps 12 $ mil (1) See Slide 20 of this presentation for a reconciliation of Gross Profit to Adjusted Gross Profit. (2) See Slides 21 and 22 of this presentation for a reconciliation of EBITDA and Adjusted EBITDA measures.
P&L reflects investment for future growth $ mil Q4 - 22 Q4 - 21 Actual VPY 2022 2021 Actual VPY Revenue 1,485 1,604 (7) % 6,174 6,304 (2) % Cost of sales 594 599 (1) % 2,294 2,382 (4) % Gross profit 891 1,005 (11) % 3,880 3,922 (1) % Non - GAAP Adjusted Gross profit (1) 937 1,059 (12) % 4,058 4,081 (1) % Selling, general and administrative 470 481 (2) % 1,704 1,668 2 % R&D 142 110 29 % 471 339 39 % Acquired IPR&D and milestones — 79 NM 107 104 NM Total research and development 142 189 (25) % 578 443 30 % Adjusted EBITDA (2) 380 470 (19) % 2,085 2,275 (8) % Diluted Earnings per Share (EPS), continuing operations (3) 0.42 0.79 (47) % 3.59 5.31 (32) % Non - GAAP adjusted diluted EPS, continuing operations (3) 0.81 1.13 (28) % 5.03 6.20 (19) % Per share impact to diluted EPS from acquired IPR&D and milestones — $ (0.24) NM $ (0.33) $ (0.33) NM Gross margin 60.0 % 62.7 % 62.8 % 62.2 % Non - GAAP Adjusted Gross margin (1) 63.1 % 66.0 % 65.7 % 64.7 % Adjusted EBITDA margin (2) 25.6 % 29.3 % 33.8 % 36.1 % 13 (1) See Slide 20 of this presentation for a reconciliation of Gross Profit to Adjusted Gross Profit. (2) See Slides 21 and 22 of this presentation for a reconciliation of EBITDA and Adjusted EBITDA measures. (3) See Slides 23 and 24 of this presentation for a reconciliation of diluted EPS to non - GAAP adjusted diluted EPS.
14 Bank covenant (*) net leverage ratio ~3.8x Net Debt as of December 31, 2022 $ mil December 2021 March 2022 June 2022 September 2022 December 2022 Cash and cash equivalents 737 694 545 499 706 Gross Debt (1) 9,134 9,094 8,893 8,699 8,913 Net Debt (1) 8,397 8,400 8,348 8,200 8,207 (*) The definition of net debt in the company's credit agreement excludes unamortized fees but includes capitalized lease ob lig ations. 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, $119 million, $113 million, $106 million and $10 5 a s of December 31, 2021, March 31, 2022, June 30, 2022, September 30, 2022, and December 31, 2022 respectively.
Net working capital normalization in fourth quarter $mil Q4 22 FY 22 Adjusted EBITDA 380 2,085 Less: Net cash interest expense (161) (382) Less: Cash taxes (50) (215) Less: Change in net working capital 222 (521) Less: Capex (10) (92) Free Cash Flow Before One - time Costs $381 $875 Less: One - time costs, spin - off (97) (358) Free Cash Flow (1) $284 $517 15 (1) Free cash flow represents net cash flows provided by operating activities plus capital expenditures, acquired in - process researc h and development, and the effect of exchange rate changes on cash and cash equivalents.
Positive impacts from: • $130M due to timing of collections • $100M FX Includes > $300M from non - recurring, spin - related build of working capital position [Organon] Confidential $ mil 16 Continued solid volume growth, partly offset by VBP, LOE and price; limited FX headwinds 500 - 600 (3) $6,174 $6,150 - $6,450 (50) - (75) (125) - (175) (75) - (125) (25) - (50) (50) - (100) (1) LOE = Loss of Exclusivity (2) VBP = Volume Based Procurement (3) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties.
(1) (2 ) Flat to +4.5% reported FX ~ (80) - (160) bps headwind to growth in 2023 FY 2023 guidance ranges 17 Provided on a Non - GAAP basis, except Revenues 2023 FY guidance Revenues $6.150 - $6.450 billion Adjusted gross margin Low - mid 60% range SG&A (as % of revenues) Mid 20% range R&D (as % of revenues) Upper single - digit Adjusted EBITDA margin 31.0% - 33.0% Interest expense ~510 million Depreciation ~130 million Effective non - GAAP tax rate 19.0% - 21.0% Fully diluted weighted avg.
Q&A
Appendix
shares outstanding ~255 million Gross margin reconciliation $ mil Q4 - 2022 Q4 - 2021 2022 2021 Revenues 1,485 1,604 6,174 6,304 Cost of sales 594 599 2,294 2,382 Gross Profit 891 1,005 3,880 3,922 Gross Margin 60.0 % 62.7 % 62.8 % 62.2 % Amortization 28 34 116 103 One - time costs (1) 14 17 49 45 Stock - based compensation 4 3 13 11 Non - GAAP Adjusted Gross Profit (2) 937 1,059 4,058 4,081 Non - GAAP Adjusted Gross Margin 63.1 % 66.0 % 65.7 % 64.7 % (1) One - time costs for the three months ended December 31, 2022 primarily include costs to stand up the company and inventory st ep - up adjustments. One - time costs for the year ended December 31, 2022 primarily include costs to stand up the company and inventory step - up adjustments as well as a $9 million impairment charge related to a l icensed intangible asset. One - time costs for the three months ended December 31, 2021 include costs to stand up the Company as well as a $7 million impair ment charge relating to a licensed intangible asset. For the year ended December 31, 2021, one - time costs include inventory discards related to separation re - labeling and other costs to stand up the Company as well as a $7 million impairment charge related to a licensed intangible asset. ( 2 ) Non - GAAP Adjusted Gross Profit is calculated by excluding amortization, one - time costs, and the portion of stock - based compensation expense allocated to Cost of sales . 20 Income from continuing operations before income taxes to Adjusted EBITDA $ mil Q4 - 2022 Q4 - 2021 Income from continuing operations before income taxes 111 236 Depreciation 24 28 Amortization (1) 28 34 Interest expense 119 98 EBITDA 282 396 Restructuring costs 17 — One - time costs (2) 58 59 Stock - based compensation (3) 23 15 Adjusted EBITDA 380 470 Adjusted EBITDA margin 25.6 % 29.3 % (1) Amortization in all periods is included in Cost of sales.
( 2 ) One - time costs primarily include costs incurred in connection with the spin - off of Organon, inventory step up adjustments and legal reserves . For the three months ended December 31 , 2022 , $ 41 million of the one - time costs are recorded in Selling, general and administrative expenses, $ 14 million are recorded in Cost of sales and $ 3 million are recorded in Research and development . For the three months ended December 31 , 2021 , $ 26 million of the one - time costs are recorded in Selling, general and administrative expenses, $ 17 million are recorded in Cost of sales, $ 9 million are recorded in Research and development, and $ 7 million in Other (income) expense . ( 3 ) For the three months ended December 31 , 2022 , approximately $ 4 million of stock - based compensation is recorded in Cost of sales, $ 16 million is recorded in Selling, general and administrative and $ 3 million is recorded in Research and development . For the three months ended December 31 , 2021 , approximately $ 3 million of stock - based compensation is recorded in Cost of sales, $ 10 million is recorded in Selling, general and administrative and $ 2 million is recorded in Research and development . 21 Income from continuing operations before income taxes to Adjusted EBITDA $ mil 2022 2021 Income from continuing operations before income taxes 1,122 1,529 Depreciation 96 92 Amortization (1) 116 103 Interest expense 422 258 EBITDA 1,756 1,982 Restructuring costs 28 3 One - time costs (2) 226 231 Stock - based compensation (3) 75 59 Adjusted EBITDA 2,085 2,275 Adjusted EBITDA margin 33.8 % 36.1 % (1) Amortization in all periods is included in Cost of sales.
( 2 ) One - time costs primarily include costs incurred in connection with the spin - off of Organon, an impairment of a licensed intangible asset, inventory step - up adjustments and legal reserves . For the year ended December 31 , 2022 , $ 143 million of the one - time costs are recorded in Selling, general and administrative expenses, $ 49 million are recorded in Cost of sales, $ 19 million are recorded in Other (income) expense, and $ 15 million are recorded in Research and development . For the year ended December 31 , 2021 , $ 165 million of the one - time costs are recorded in Selling, general and administrative expenses (which includes $ 23 million pertaining to the acquisition of Alydia in the second quarter 2021 ), $ 45 million are recorded in Cost of sales, $ 14 million are recorded in Research and development, and $ 7 million are recorded in Other (income) expense . (3) For the year ended December 31, 2022, approximately $13 million of stock - based compensation is recorded in Cost of sales, $5 1 million is recorded in Selling, general and administrative and $11 million is recorded in Research and development. For the year ended December 31, 2021, approximately $11 million of stock - based compensation is recorded in Cost of sales, $36 million is recorded in Selling, general and administrative and $12 million is recorded in Research and development. 22 Income from continuing operations before income taxes to Adjusted Net Income $ mil (except EPS) Q4 - 2022 Q4 - 2021 Income from continuing operations before income taxes 111 236 Amortization (1) 28 34 Restructuring costs 17 0 One - time costs (2) 58 59 Stock - based compensation (3) 23 15 Total Adjustments 126 108 Non - GAAP pre - tax income, continuing operations 237 344 Taxes on income as reported in accordance with GAAP 3 34 Tax benefit on adjustments 23 18 Tax benefit on GAAP - only discrete items 3 5 Non - GAAP adjusted taxes on income 29 57 Non - GAAP adjusted net income, continuing operations 208 287 Non - GAAP adjusted net income, continuing operations per diluted share $ 0.81 $ 1.13 (1) Amortization in all periods is included in Cost of sales.
( 2 ) One - time costs primarily include costs incurred in connection with the spin - off of Organon, inventory step up adjustments and legal reserves . For the three months ended December 31 , 2022 , $ 41 million of the one - time costs are recorded in Selling, general and administrative expenses, $ 14 million are recorded in Cost of sales and $ 3 million are recorded in Research and development . For the three months ended December 31 , 2021 , $ 26 million of the one - time costs are recorded in Selling, general and administrative expenses, $ 17 million are recorded in Cost of sales, $ 9 million are recorded in Research and development, and $ 7 million in Other (income) expense . ( 3 ) For the three months ended December 31 , 2022 , approximately $ 4 million of stock - based compensation is recorded in Cost of sales, $ 16 million is recorded in Selling, general and administrative and $ 3 million is recorded in Research and development . For the three months ended December 31 , 2021 , approximately $ 3 million of stock - based compensation is recorded in Cost of sales, $ 10 million is recorded in Selling, general and administrative and $ 2 million is recorded in Research and development . 23 Income from continuing operations before income taxes to Adjusted Net Income $ mil (except EPS) 2022 2021 Income from continuing operations before income taxes 1,122 1,529 Amortization (1) 116 103 Restructuring costs 28 3 One - time costs (2) 226 231 Stock - based compensation (3) 75 59 Total Adjustments 445 396 Non - GAAP pre - tax income, continuing operations 1,567 1,925 Taxes on income as reported in accordance with GAAP 205 178 Tax benefit on adjustments 78 74 Tax benefit on GAAP - only discrete items (4) — 96 Non - GAAP adjusted taxes on income 283 348 Non - GAAP adjusted net income, continuing operations 1,284 1,577 Non - GAAP adjusted net income, continuing operations per diluted share $ 5.03 $ 6.20 (1) Amortization in all periods is included in Cost of sales.
( 2 ) One - time costs primarily include costs incurred in connection with the spin - off of Organon, an impairment of a licensed intangible asset, inventory step - up adjustments and legal reserves . For the year ended December 31 , 2022 , $ 143 million of the one - time costs are recorded in Selling, general and administrative expenses, $ 49 million are recorded in Cost of sales, $ 19 million are recorded in Other (income) expense, and $ 15 million are recorded in Research and development . For the year ended December 31 , 2021 , $ 165 million of the one - time costs are recorded in Selling, general and administrative expenses (which includes $ 23 million pertaining to the acquisition of Alydia in the second quarter 2021 ), $ 45 million are recorded in Cost of sales, $ 14 million are recorded in Research and development, and $ 7 million are recorded in Other (income) expense . ( 3 ) For the year ended December 31 , 2022 , approximately $ 13 million of stock - based compensation is recorded in Cost of sales, $ 51 million is recorded in Selling, general and administrative and $ 11 million is recorded in Research and development . For the year ended December 31 , 2021 , approximately $ 11 million of stock - based compensation is recorded in Cost of sales, $ 36 million is recorded in Selling, general and administrative and $ 12 million is recorded in Research and development . (4) For the three months and year ended December 31, 2021, the Company recorded a tax benefit of approximately $5 million and $7 5 million, respectively, related to a portion of non - US step up in tax basis as a result of its separation from 24 Franchise performance $ mil Q4 - 2022 Q4 - 2021 Actual VPY Ex - FX VPY 2022 2021 Actual VPY Ex - FX VPY Women’s Health 433 415 4% 9% 1,673 1,612 4% 7% Biosimilars 134 118 13% 17% 481 424 13% 17% Est.
Brands 888 1,037 (14)% (4)% 3,874 4,068 (5)% 3% Other (1) 30 34 (8)% (9)% 146 200 (27)% (29)% Total Revenues 1,485 1,604 (7)% 1% 6,174 6,304 (2)% 4% (1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties, and allocated amounts f rom pre - spin revenue hedging activities. 25 Number of products 13 5 49 Women’s Health Biosimilars Established Brands Broad and diverse portfolio 26 TM TM
Free cash flow providing opportunity for meaningful business development in growth pillars 27 Commercialized/soon to be commercialized asset Building a pipeline Licensing Agreement for Xaciato Œ (clindamycin phosphate vaginal gel, 2%) March 2022 Bacterial Vaginosis Gel FDA - approved for BV in females 12 and over, the most common cause of vaginits worldwide estimated to affect approximately 21 million women in the US. year (1) Marvelon Œ (desogestrel and ethinyl estradiol) and Mercilon Œ (desogestrel and ethinyl estradiol) February 2022 Contraception Expanding portfolio - recapturing commercial rights to certain currently marketed products in Asia Acquisition of Alydia Health/JADA® System June 2021 Medical Device Postpartum hemorrhage - one of the most common complications of birth, requiring pharmacologic treatment in up to 10% of mothers (2) Claria Medical January 2023 Medical Device Being studied for use during minimally invasive laparoscopic hysterectomy - one of the most commonly performed surgeries for women Cirqle Biomedical July 2022 Contraception Expanding portfolio - preclinical, non - hormonal contraceptive candidate, large, unmet need for non - hormonal contraception Licensing Agreement for biosimilar candidates referencing Perjeta (4) and Prolia (4) /Xgeva (4) through Shanghai Henlius June 2022 Biosimilar Candidates for Osteoporosis and Breast Cancer Exclusive global commercialization rights except for China; including Hong Kong, Macau and Taiwan Licensing Agreement for Ebopiprant July 2021 Pre - term Labor 15 million babies (11.1% of all live births) born pre - term every year (3) Forendo Pharma December 2021 Endometriosis Clinical stage / Phase 2a/2b - chronic condition that affects up to 1 in 10 women of reproductive age (1) Centers for Disease Control and Prevention Bacterial Vaginosis CDC Fact Sheet: https://www.cdc.gov/std/bv/stdfact - backterial - vaginosis (2) Widmer M et al. "Heat - Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth." N Engl J Med 2018; 379:743 - 752 (3) WHO Key Facts, 2018: https://www.who.int/news - room/fact - sheets/detail/preterm - birth (4) Perjeta is a trademark registered in the U.S. in the name of Genentech, Inc.; Prolia and Xgeva are trademarks registered in the U.S. in the name of Amgen Inc.