UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Emerging growth company
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| Item 2.02 | Results of Operations and Financial Condition. |
On February 17, 2022, Organon & Co. (the “Company”) issued a press release (the “Earnings Release”) regarding its results for the quarter and full year ended December 31, 2021. 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 17, 2022, the Company made available the Company Information Presentation relating to its financial results for the quarter and full year ended December 31, 2021. The Company Information Presentation may be accessed within the investor relations section of the Company’s website, http://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 17, 2022, 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 17, 2022
Exhibit 99.1
| Media Contacts: | Karissa Peer | Investor Contacts: | Jennifer Halchak |
|
(614) 314-8094
Kate Vossen (732) 675-8448 |
(201) 275-2711
Edward Barger (267) 614-4669 |
Organon reports results for the fourth quarter and full year ended December 31, 2021
Nexplanon®(etonogestrel implant), fertility, biosimilars grew double digits for full year
| • | Full year 2021 revenue of $6.3 billion |
| • | Income from continuing operations before tax of $1.5 billion for full year 2021 |
| • | Full year Adjusted EBITDA of $2.4 billion |
| • | Company executing on business development; four transactions since spin |
| • | Full year 2022 financial guidance provided; revenue range of $6.1 billion to $6.4 billion and Adjusted EBITDA margins in the range of 34%-36% |
Jersey City, N.J., February 17, 2022 – Organon (NYSE: OGN) today announced its results for the fourth quarter and full year ended December 31, 2021.
Organon also announced that its 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 17, 2022 to stockholders of record at the close of business on February 28, 2022.
"In 2021 we delivered on our financial objectives across the board. Organon has taken significant steps to advance our vision to become a leader in women’s health through meaningful business development that addresses areas of significant unmet need for women and society," said Kevin Ali, Organon's CEO. "We continue to balance our growth objectives against our commitment to lower leverage, and in the fourth quarter we repaid $100 million of our term loans. Overall, we are well positioned as we head into 2022."
Fourth quarter 2021 revenue
| in $ millions | Q4 2021 | Q4 2020 | VPY | VPY ex-FX | ||||||||||||
| Women’s Health | $ | 415 | $ | 390 | 6 | % | 6 | % | ||||||||
| Biosimilars | 118 | 103 | 15 | % | 14 | % | ||||||||||
| Established Brands | 1,037 | 1,062 | (2 | )% | (2 | )% | ||||||||||
| Other(1) | 34 | 58 | (42 | )% | (70 | )% | ||||||||||
| Revenue | $ | 1,604 | $ | 1,613 | (1 | )% | (1 | )% | ||||||||
(1) Other includes manufacturing sales to Merck & Co., Inc.(“Merck”) and other third parties, and allocated amounts from pre-spin revenue hedging activities through the date of separation.
Total net revenue was $1,604 million for the fourth quarter of 2021, a decrease of 1%, both as-reported and excluding the impacts of foreign currency (ex-FX), compared with fourth quarter of 2020. Strong sales for Nexplanon, together with growth in biosimilars were offset by declines in Established Brands and supply sales to Merck and other third parties.
Women’s Health increased 6% both as-reported and ex-FX in the fourth quarter 2021 compared with the fourth quarter of 2020 driven primarily by Nexplanon, which increased 37% ex-FX in the fourth quarter 2021 compared with the fourth quarter of 2020. Nexplanon’s growth in the quarter was due to increased demand in the United States, as well as tenders won, which can be variable quarter to quarter. The increase in Women’s Health was partially offset by a decline in sales of Nuvaring® (etonogestrel/ethinyl estradiol vaginal ring) which continues to be impacted by generic competition.
Biosimilars revenue grew 15% as-reported and 14% ex-FX in the fourth quarter 2021 compared with fourth quarter 2020, driven by continued growth in the United States for Renflexis® (infliximab-abda) and growth in Canada. The biosimilars portfolio also benefited from the continued uptake of Ontruzant® (trastuzumab-dttb) in the United States, partially offset by a decrease in the European Union, due to increasing competitive pressures, and Latin America, due to the timing of tenders in Brazil.
Established Brands represents a broad portfolio of well-known medicines, which are generally beyond market exclusivity, including leading brands in cardiovascular, respiratory, dermatology and non-opioid pain management, and for which generic competition varies by market. In 2021, declines related to loss of exclusivity (LOE) moderated, and in the fourth quarter the franchise was down 2% on both a nominal and constant currency basis. The decline in Established Brands during the fourth quarter of 2021 compared to the fourth quarter of 2020 was primarily due to a terminated agreement in Korea for Rosuzet™ (ezetimibe, rosuvastatin as calcium), loss of exclusivity for Zetia® (ezetimibe) in Japan in June 2020, the negative impact of Volume Based Procurement (VBP) in China, which was partially offset by growth in the retail channel and brands not impacted by VBP, as well as growth of Atozet™ (ezetimibe and atorvastatin calcium trihydrate) and certain products in the respiratory and non-opioid pain franchises.
Fourth quarter 2021 profitability
| in $ millions, except per share amounts | Q4 2021 | Q4 2020 | VPY | |||||||||
| Revenue | $ | 1,604 | $ | 1,613 | (1 | )% | ||||||
| Cost of sales | 599 | 586 | 2 | % | ||||||||
| Gross profit | 1,005 | 1,027 | (2 | )% | ||||||||
| Gross margin | 62.7 | % | 63.7 | % | ||||||||
| Non-GAAP adjusted gross profit(*) | 1,059 | 1,051 | 1 | % | ||||||||
| Non-GAAP adjusted gross margin | 66.0 | % | 65.2 | % | ||||||||
| Adjusted EBITDA(*) | 549 | 680 | (19 | )% | ||||||||
| Adjusted EBITDA margin | 34.2 | % | 42.2 | % | ||||||||
| Net Income, continuing operations | 202 | 376 | (46 | )% | ||||||||
| Non-GAAP adjusted net income, continuing operations(*) | 349 | 494 | (29 | )% | ||||||||
| Diluted Earnings per Share, continuing operations | 0.79 | 1.48 | (47 | )% | ||||||||
| Non-GAAP adjusted Diluted Earnings per Share, continuing operations(*) | 1.37 | 1.95 | (30 | )% | ||||||||
(*) See Tables 4,5 and 6 for reconciliations of GAAP to non-GAAP measures.
Gross margin was 62.7% as-reported and 66.0% on an adjusted basis in the fourth quarter of 2021 compared with 63.7% as-reported and 65.2% on an adjusted basis in the fourth quarter of 2020.
Adjusted EBITDA margin was 34.2% in the fourth quarter of 2021 compared with 42.2% in the fourth quarter of 2020. The decline reflects costs incurred to establish Organon as a stand-alone entity.
Net income from continuing operations for the fourth quarter of 2021 was $202 million, or $0.79 per diluted share, compared with $376 million, or $1.48 per diluted share, in the fourth quarter of 2020. Non-GAAP Adjusted net income from continuing operations was $349 million, or $1.37 per diluted share, compared with $494 million, or $1.95 per diluted share, in 2020.
2021 revenue
| in $ millions | FY 2021 | FY 2020 | VPY | VPY ex-FX | ||||||||||||
| Women’s Health | $ | 1,612 | $ | 1,555 | 4 | % | 2 | % | ||||||||
| Biosimilars | 424 | 330 | 28 | % | 25 | % | ||||||||||
| Established Brands | 4,068 | 4,540 | (10 | )% | (13 | )% | ||||||||||
| Other(1) | 200 | 107 | 87 | % | 67 | % | ||||||||||
| Revenue | $ | 6,304 | $ | 6,532 | (3 | )% | (6 | )% | ||||||||
(1) Other includes manufacturing sales to Merck and other third parties, and allocated amounts from pre-spin revenue hedging activities through the date of separation.
Total net revenue was $6,304 million for full year 2021, a decrease of 3% as-reported and 6% ex-FX, compared with 2020. The sales decline reflects decreases across certain markets within the Established Brands business, primarily due to ongoing competition after loss of exclusivity. The overall sales decline was offset by higher sales of Women's Health products, notably Nexplanon, Follistim AQ® (follitropin beta injection) and ganirelix acetate injection due to increasing demand, higher sales of biosimilars resulting from the continued uptake of Renflexis and Ontruzant in the United States, and the favorable impact of foreign exchange.
Women’s Health increased 4% as-reported and 2% ex-FX for full year 2021 compared with 2020, driven by Nexplanon which increased 12% ex-FX in 2021. This was partially offset by a 21% ex-FX decline in Nuvaring which continues to be impacted by generic competition, and by declining sales in the United States of the authorized generic of Nuvaring. Follistim AQ (marketed in most countries outside the United States as Puregon™), a fertility treatment, increased 19% ex-FX in 2021 compared with 2020, primarily due to volume growth, as well as recovery from the COVID-19 pandemic in the United States and China.
Biosimilars revenue grew 28% as-reported and 25% ex-FX for full year 2021 compared with 2020, driven by continued growth in the United States for Renflexis and growth in Canada. The biosimilars portfolio also benefited from the launch of Hadlima® (adalimumab-bwwd) and Aybintio® (bevacizumab) in certain ex-US markets during the year, and the continued uptake of Ontruzant in the United States, partially offset by revenue declines in the European Union due to increasing competitive pressures.
Revenue for Established Brands was down 10% as-reported and down 13% ex-FX for the full year 2021, primarily driven by the impact of the loss of exclusivity of Zetia in Japan in June 2020. Excluding the impact of the loss of exclusivity, Established Brands revenue was down 8% ex-FX. Additionally, during 2021, the Established Brands portfolio in China was subject to the negative impact of the third round of VBP, the largest so far for Organon. The associated decline was partially offset by growth in brands in the hospital channel not impacted by VBP, the partial recovery of the respiratory market as well as growth in the retail segment which accounts for approximately 50% of the total sales of Established Brands in China.
Full year 2021 profitability
| in $ millions, except per share amounts | 2021 | 2020 | VPY | |||||||||
| Revenue | $ | 6,304 | $ | 6,532 | (3 | )% | ||||||
| Cost of sales | 2,382 | 2,119 | 12 | % | ||||||||
| Gross profit | 3,922 | 4,413 | (11 | )% | ||||||||
| Gross margin | 62.2 | % | 67.6 | % | ||||||||
| Non-GAAP adjusted gross profit(*) | 4,081 | 4,516 | (10 | )% | ||||||||
| Non-GAAP adjusted gross margin | 64.7 | % | 69.1 | % | ||||||||
| Adjusted EBITDA(*) | 2,379 | 3,120 | (24 | )% | ||||||||
| Adjusted EBITDA margin | 37.7 | % | 47.8 | % | ||||||||
| Net Income, continuing operations | 1,351 | 2,256 | (40 | )% | ||||||||
| Non-GAAP adjusted net income, continuing operations(*) | 1,662 | 2,523 | (34 | )% | ||||||||
| Diluted Earnings per Share, continuing operations | 5.31 | 8.90 | (40 | )% | ||||||||
| Non-GAAP Adjusted Diluted Earnings per Share, continuing operations(*) | 6.54 | 9.95 | (34 | )% | ||||||||
(*) See Tables 4,5 and 6 for reconciliations of GAAP to non-GAAP measures.
Gross margin was 62.2% as-reported and 64.7% on an adjusted basis for full year 2021 compared with 67.6% as-reported and 69.1% on an adjusted basis in 2020. The year-over-year decrease reflects costs of establishing Organon as an independent company, including certain costs related to manufacturing agreements between the company and its former parent company, which have lower gross margin percentages compared to third party product sales and purchases.
Adjusted EBITDA margin was 37.7% for 2021 compared with 47.8% in 2020, which reflects costs incurred to establish Organon as a stand-alone entity.
Net income from continuing operations for 2021 was $1,351 million, or $5.31 per diluted share, compared with $2,256 million, or $8.90 per diluted share in 2020. Non-GAAP Adjusted net income from continuing operations was $1,662 million, or $6.54 per diluted share, compared with $2,523 million, or $9.95 per diluted share in 2020.
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 17, 2022 to stockholders of record at the close of business on February 28, 2022.
As of December 31, 2021, cash and cash equivalents were $737 million, and gross debt was $9,134 million, resulting in net debt of $8,397 million. Total debt as of December 31, 2021 reflects a discretionary fourth quarter prepayment of $100 million on the company’s term loans.
Full year guidance – all guidance provided on a Non-GAAP basis
Organon does not provide GAAP financial measures (other than revenue) on a forward-looking basis because the company is unable to predict with reasonable certainty and without unreasonable effort, items such as, the ultimate outcome of legal proceedings, unusual gains and losses, 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 provided financial guidance for full year 2022, which is presented on a non-GAAP basis.
| Non-GAAP basis (except revenue) | Guidance | |
| Revenue | $6.1B - $6.4B | |
| Adjusted gross margin | Mid 60% | |
| SG&A as % of sales | Mid 20% | |
| R&D as % of sales | Mid to upper single digit | |
| Adjusted EBITDA margin | 34%-36% | |
| Interest expense | ~$400 million | |
| Depreciation | $100-$115 million | |
| Effective Non-GAAP tax rate | 17.5%-19.5% | |
| Fully diluted weighted avg. shares outstanding | ~255 million |
Webcast Information
Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its fourth quarter and full year 2021 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/. 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 using conference ID#2682555 and by clicking on this link: http://www.directeventreg.com/registration/event/2682555. 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 through a spin-off from Merck, (NYSE: MRK) known as MSD outside of the United States and Canada, to 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 9,500 employees with headquarters located in Jersey City, New Jersey.
For more information, visit https://www.organon.com and connect with us on LinkedIn and Instagram.
Non-GAAP financial measures
Non-GAAP results, such as Adjusted EBITDA, Adjusted Net Income, and Adjusted Diluted EPS, are presented only as a supplement to the company’s financial statements based on GAAP. Non-GAAP financial information is provided to enhance understanding of the company’s financial performance, but none of these non-GAAP financial measures are recognized terms under GAAP, and non-GAAP measures should not be considered in isolation from, or as a substitute analysis for, the company’s results of operations as determined in accordance with GAAP. Definitions and reconciliations of non-GAAP measures to the most directly comparable GAAP measures are provided within the schedules attached to this release. The company uses non-GAAP 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. The company also believes that investors may find non-GAAP financial measures useful for the same reasons, although investors are cautioned that non-GAAP financial measures are not a substitute for GAAP disclosures. The non-GAAP financial measures are not presented in accordance with GAAP. Please refer to the appendix of this press release for reconciliations of non-GAAP financial measures contained herein to the most directly comparable GAAP measures. The company’s full-year 2022 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.
Forward-Looking Statements
Except for historical information herein, this news 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.
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; general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; 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; the company’s ability to accurately predict future market conditions; 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 its registration statement on Form 10 and subsequent periodic filings, available at the SEC’s Internet site (www.sec.gov).
TABLE 1
Organon & Co.
Condensed Consolidated Statement of Income
(Unaudited, $ in millions except share and per share amounts)
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenues | $ | 1,604 | $ | 1,613 | $ | 6,304 | $ | 6,532 | ||||||||
| Costs, Expenses and Other | ||||||||||||||||
| Cost of sales | 599 | 586 | 2,382 | 2,119 | ||||||||||||
| Selling, general and administrative | 481 | 434 | 1,668 | 1,356 | ||||||||||||
| Research and development | 189 | 60 | 443 | 210 | ||||||||||||
| Restructuring costs | — | 17 | 3 | 60 | ||||||||||||
| Other (income) expense, net | 99 | (9 | ) | 279 | 35 | |||||||||||
| 1,368 | 1,088 | 4,775 | 3,780 | |||||||||||||
| Income From Continuing Operations Before Income Taxes | 236 | 525 | 1,529 | 2,752 | ||||||||||||
| Taxes on Income | 34 | 149 | 178 | 496 | ||||||||||||
| Net Income From Continuing Operations | 202 | 376 | 1,351 | 2,256 | ||||||||||||
| Loss From Discontinued Operations - Net of Tax | — | (8 | ) | — | (96 | ) | ||||||||||
| Net Income | $ | 202 | $ | 368 | 1,351 | 2,160 | ||||||||||
| Earnings (Loss) per Share Attributable to Organon & Co. Stockholders - Basic: | ||||||||||||||||
| Continuing operations | 0.80 | 1.48 | 5.33 | 8.90 | ||||||||||||
| Discontinued operations | — | (0.03 | ) | — | (0.38 | ) | ||||||||||
| Net Earnings per Share Attributable to Organon & Co. Stockholders | 0.80 | 1.45 | 5.33 | 8.52 | ||||||||||||
| Earnings (Loss) per Share Attributable to Organon & Co. Stockholders - Diluted: | ||||||||||||||||
| Continuing operations | 0.79 | 1.48 | $ | 5.31 | $ | 8.90 | ||||||||||
| Discontinued operations | — | (0.03 | ) | $ | — | $ | (0.38 | ) | ||||||||
| Net Earnings per Share Attributable to Organon & Co. Stockholders | 0.79 | 1.45 | $ | 5.31 | $ | 8.52 | ||||||||||
| Weighted Average Shares Outstanding: | ||||||||||||||||
| Basic | 253,549,167 | 253,516,000 | 253,537,941 | 253,516,000 | ||||||||||||
| Diluted | 254,550,738 | 253,516,000 | 254,192,700 | 253,516,000 | ||||||||||||
TABLE 2
Organon & Co.
Sales by top products
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||||||||||||||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||||||||||||||||||||||||||||
| ($ 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 | $ | 143 | $ | 83 | $ | 226 | $ | 114 | $ | 50 | $ | 165 | $ | 532 | $ | 237 | $ | 769 | $ | 488 | $ | 192 | $ | 680 | ||||||||||||||||||||||||
| Follistim AQ | 29 | 30 | 59 | 24 | 33 | 57 | 110 | 127 | 237 | 84 | 108 | 193 | ||||||||||||||||||||||||||||||||||||
| NuvaRing | 18 | 27 | 44 | 25 | 28 | 53 | 85 | 106 | 191 | 111 | 126 | 236 | ||||||||||||||||||||||||||||||||||||
| ganirelix acetate injection | 3 | 22 | 26 | 4 | 21 | 25 | 22 | 88 | 111 | 11 | 69 | 81 | ||||||||||||||||||||||||||||||||||||
| Cerazette | — | 18 | 18 | — | 16 | 16 | — | 70 | 70 | — | 67 | 67 | ||||||||||||||||||||||||||||||||||||
| Other Women's Health (1) | 14 | 29 | 42 | 45 | 30 | 74 | 96 | 139 | 234 | 165 | 133 | 298 | ||||||||||||||||||||||||||||||||||||
| Biosimilars | ||||||||||||||||||||||||||||||||||||||||||||||||
| Renflexis | 46 | 5 | 51 | 35 | 4 | 39 | 164 | 21 | 186 | 123 | 12 | 135 | ||||||||||||||||||||||||||||||||||||
| Ontruzant | 14 | 11 | 26 | 2 | 35 | 37 | 34 | 92 | 126 | 3 | 113 | 115 | ||||||||||||||||||||||||||||||||||||
| Brenzys | — | 28 | 28 | — | 23 | 23 | — | 63 | 63 | — | 74 | 74 | ||||||||||||||||||||||||||||||||||||
| Other Biosimilars (1) | — | 13 | 13 | — | 4 | 4 | — | 49 | 49 | — | 6 | 6 | ||||||||||||||||||||||||||||||||||||
| Established Brands | ||||||||||||||||||||||||||||||||||||||||||||||||
| Cardiovascular | ||||||||||||||||||||||||||||||||||||||||||||||||
| Zetia | 4 | 92 | 96 | 3 | 94 | 98 | 10 | 368 | 378 | (1 | ) | 483 | 482 | |||||||||||||||||||||||||||||||||||
| Vytorin | 3 | 34 | 37 | 3 | 40 | 43 | 11 | 153 | 164 | 12 | 170 | 182 | ||||||||||||||||||||||||||||||||||||
| Atozet | — | 110 | 110 | — | 105 | 105 | — | 458 | 458 | — | 453 | 453 | ||||||||||||||||||||||||||||||||||||
| Rosuzet | — | 19 | 19 | — | 36 | 36 | — | 68 | 68 | — | 130 | 130 | ||||||||||||||||||||||||||||||||||||
| Cozaar/Hyzaar | 3 | 90 | 93 | 4 | 90 | 94 | 12 | 345 | 357 | 21 | 365 | 386 | ||||||||||||||||||||||||||||||||||||
| Zocor | 1 | 15 | 16 | 1 | 18 | 19 | 4 | 61 | 65 | 3 | 75 | 77 | ||||||||||||||||||||||||||||||||||||
| Other Cardiovascular (1) | — | 27 | 27 | — | 39 | 39 | — | 126 | 126 | — | 162 | 162 | ||||||||||||||||||||||||||||||||||||
| Respiratory | ||||||||||||||||||||||||||||||||||||||||||||||||
| Singulair | 5 | 108 | 113 | 4 | 120 | 124 | 15 | 398 | 413 | 18 | 444 | 462 | ||||||||||||||||||||||||||||||||||||
| Nasonex | 2 | 61 | 62 | 3 | 55 | 57 | 4 | 201 | 206 | 12 | 206 | 218 | ||||||||||||||||||||||||||||||||||||
| Dulera | 34 | 10 | 44 | 33 | 8 | 41 | 154 | 36 | 190 | 188 | 34 | 222 | ||||||||||||||||||||||||||||||||||||
| Clarinex | 1 | 27 | 28 | 2 | 19 | 21 | 6 | 106 | 111 | 7 | 123 | 130 | ||||||||||||||||||||||||||||||||||||
| Asmanex | 14 | 2 | 16 | 17 | 2 | 20 | 57 | 7 | 63 | 76 | 8 | 83 | ||||||||||||||||||||||||||||||||||||
| Other Respiratory (1) | (1 | ) | 10 | 9 | 2 | 7 | 9 | — | 26 | 26 | 3 | 32 | 35 | |||||||||||||||||||||||||||||||||||
| Non-Opioid Pain, Bone and Dermatology | ||||||||||||||||||||||||||||||||||||||||||||||||
| Arcoxia | — | 60 | 60 | — | 54 | 54 | — | 244 | 244 | — | 258 | 258 | ||||||||||||||||||||||||||||||||||||
| Fosamax | 1 | 42 | 43 | 1 | 39 | 40 | 4 | 172 | 175 | 4 | 176 | 180 | ||||||||||||||||||||||||||||||||||||
| Diprospan | — | 33 | 33 | — | 32 | 32 | — | 125 | 125 | — | 118 | 118 | ||||||||||||||||||||||||||||||||||||
| Diprosone | — | 22 | 22 | — | 23 | 23 | 1 | 86 | 87 | 1 | 82 | 83 | ||||||||||||||||||||||||||||||||||||
| Other Non-Opioid Pain, Bone and Dermatology (1) | 4 | 46 | 50 | 5 | 46 | 50 | 15 | 183 | 199 | 9 | 186 | 195 | ||||||||||||||||||||||||||||||||||||
| Other | ||||||||||||||||||||||||||||||||||||||||||||||||
| Proscar | — | 25 | 26 | — | 22 | 22 | 1 | 116 | 117 | 2 | 174 | 176 | ||||||||||||||||||||||||||||||||||||
| Propecia | 4 | 31 | 36 | 2 | 36 | 39 | 9 | 127 | 136 | 10 | 119 | 129 | ||||||||||||||||||||||||||||||||||||
| Sinemet | — | 17 | 17 | — | 20 | 20 | — | 71 | 71 | (1 | ) | 78 | 77 | |||||||||||||||||||||||||||||||||||
| Remeron | 1 | 14 | 15 | 1 | 16 | 16 | 3 | 62 | 66 | 2 | 61 | 64 | ||||||||||||||||||||||||||||||||||||
| Other (1) | 7 | 58 | 65 | 9 | 50 | 60 | 37 | 185 | 223 | 53 | 185 | 238 | ||||||||||||||||||||||||||||||||||||
| Other (2) | (3 | ) | 38 | 34 | 1 | 57 | 58 | (3 | ) | 205 | 200 | 4 | 102 | 107 | ||||||||||||||||||||||||||||||||||
| Total Revenue | $ | 347 | $ | 1,257 | $ | 1,604 | $ | 340 | $ | 1,272 | $ | 1,613 | $ | 1,383 | $ | 4,921 | $ | 6,304 | $ | 1,408 | $ | 5,124 | $ | 6,532 | ||||||||||||||||||||||||
U.S. plus international may not equal total due to rounding.
| (1) | Includes sales of products not listed separately. 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 and other third parties, and allocated amounts from pre-spin revenue hedging activities through the date of separation. |
TABLE 3
Organon & Co.
Sales by geographic area
(Unaudited, $ in millions)
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| ($ in millions) | 2021 | 2020 | 2021 | 2020 | ||||||||||||
| Europe and Canada | $ | 427 | $ | 440 | $ | 1,741 | $ | 1,726 | ||||||||
| United States | 347 | 340 | 1,383 | 1,408 | ||||||||||||
| Asia Pacific and Japan | 299 | 345 | 1,173 | 1,535 | ||||||||||||
| China | 240 | 218 | 933 | 873 | ||||||||||||
| Latin America, Middle East, Russia and Africa | 246 | 208 | 841 | 857 | ||||||||||||
| Other(1) | 45 | 62 | 233 | 133 | ||||||||||||
| Revenue | $ | 1,604 | $ | 1,613 | $ | 6,304 | $ | 6,532 | ||||||||
(1) Other includes manufacturing sales to Merck and other third parties, and allocated amounts from pre-spin revenue hedging activities through the date of separation.
TABLE 4
Reconciliation of GAAP Gross Margin to Non-GAAP Adjusted Gross Profit and Adjusted Gross Margin
($ in millions)
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue | $ | 1,604 | $ | 1,613 | $ | 6,304 | $ | 6,532 | ||||||||
| Cost of sales | 599 | 586 | 2,382 | 2,119 | ||||||||||||
| Gross profit | 1,005 | 1,027 | 3,922 | 4,413 | ||||||||||||
| Gross margin | 62.7 | % | 63.7 | % | 62.2 | % | 67.6 | % | ||||||||
| Amortization | 34 | 21 | 103 | 86 | ||||||||||||
| One-time costs(1) | 17 | — | 45 | — | ||||||||||||
| Stock-based compensation | 3 | 3 | 11 | 17 | ||||||||||||
| Non-GAAP adjusted gross profit(2) | 1,059 | 1,051 | 4,081 | 4,516 | ||||||||||||
| Non-GAAP adjusted gross margin | 66.0 | % | 65.2 | % | 64.7 | % | 69.1 | % | ||||||||
(1) One-time costs for the three months ended December 31, 2021 include costs to stand up the Company as well as a $7 million impairment charge relating to a licensed intangible asset. For the twelve month period ended December 31, 2021, one time costs include inventory discards related to separation re-labeling and other costs to stand up the Company.
(2) Non-GAAP adjusted gross profit is calculated by excluding amortization, one-time costs described above, and the portion of stock-based compensation expense allocated to Cost of sales.
TABLE 5
Organon & Co.
Reconciliation of GAAP Net Income from Continuing Operations to Adjusted EBITDA
($ in millions)
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Net income from continuing operations before income tax | $ | 236 | $ | 525 | $ | 1,529 | $ | 2,752 | ||||||||
| Depreciation | 28 | 14 | 92 | 56 | ||||||||||||
| Amortization(1) | 34 | 21 | 103 | 86 | ||||||||||||
| Interest expense | 98 | — | 258 | — | ||||||||||||
| EBITDA | 396 | 560 | 1,982 | 2,894 | ||||||||||||
| Restructuring costs | — | 17 | 3 | 60 | ||||||||||||
| One-time costs(2) | 59 | 95 | 231 | 126 | ||||||||||||
| Acquired in-process research and development(3) | 79 | — | 104 | — | ||||||||||||
| Stock-based compensation | 15 | 8 | 59 | 40 | ||||||||||||
| Adjusted EBITDA | $ | 549 | $ | 680 | $ | 2,379 | $ | 3,120 | ||||||||
| Adjusted EBITDA margin | 34.2 | % | 42.2 | % | 37.7 | % | 47.8 | % | ||||||||
(1) Amortization in all periods is included in Cost of sales.
(2) For the three months ended December 31, 2021, one-time costs primarily include costs incurred in connection with the spin-off of Organon as well as $5 million of transaction costs pertaining to the Forendo acquisition and a $7 million impairment charge of a licensed intangible asset. For the three months ended December 31, 2021, approximately $26 million of the one-time costs are recorded in Selling, general and administrative expenses, approximately $17 million are recorded in Cost of sales, approximately $9 million are recorded in Research and development, and $7 million in Other (income) expense, net. For the three months ended December 31, 2020, $95 million of the one-time costs are classified in Selling, general and administrative expenses.
For the twelve months ended December 31, 2021, approximately $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), approximately $45 million are recorded in Cost of sales, $14 million are recorded in Research and development, and $7million are recorded in Other (income) expense, net. For the twelve months ended December 31, 2020, $126 million of one-time costs are classified in Selling, general and administrative expenses.
(3) Costs represent $79 million related to the Forendo acquisition in the fourth quarter 2021 and the twelve month period for 2021 includes the $25 million upfront licensing payment associated with ObsEva in the third quarter 2021, both of which were recorded in Research and development expense.
TABLE 6
Organon & Co.
Reconciliation of GAAP Net Income to Non-GAAP Adjusted Net Income
($ in millions, except per share amounts)
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Net income from continuing operations before income tax | $ | 236 | $ | 525 | $ | 1,529 | $ | 2,752 | ||||||||
| Adjustments: | ||||||||||||||||
| Amortization(1) | 34 | 21 | 103 | 86 | ||||||||||||
| Restructuring costs | — | 17 | 3 | 60 | ||||||||||||
| One-time costs(2) | 59 | 95 | 231 | 126 | ||||||||||||
| Acquired in-process research and development(3) | 79 | — | 104 | — | ||||||||||||
| Stock-based compensation | 15 | 8 | 59 | 40 | ||||||||||||
| Total Adjustments | 187 | 141 | 500 | 312 | ||||||||||||
| Non-GAAP pre-tax income from continuing operations | 423 | 666 | 2,029 | 3,064 | ||||||||||||
| Taxes on income as reported in accordance with GAAP | 34 | 149 | 178 | 496 | ||||||||||||
| Tax benefit on adjustments | 35 | 23 | 93 | 45 | ||||||||||||
| Tax benefit on GAAP-only discrete items(4) | 5 | — | 96 | — | ||||||||||||
| Non-GAAP adjusted taxes on income | 74 | 172 | 367 | 541 | ||||||||||||
| Non-GAAP adjusted net income, continuing operations | $ | 349 | $ | 494 | $ | 1,662 | $ | 2,523 | ||||||||
| Non-GAAP adjusted net income, continuing operations per diluted share | $ | 1.37 | $ | 1.95 | $ | 6.54 | $ | 9.95 | ||||||||
(1) Amortization in all periods is included in Cost of sales.
(2) For the three months ended December 31, 2021, one-time costs primarily include costs incurred in connection with the spin-off of Organon as well as $5 million of transaction costs pertaining to the Forendo acquisition and a $7 million impairment charge of a licensed intangible asset. For the three months ended December 31, 2021, approximately $26 million of the one-time costs are recorded in Selling, general and administrative expenses, approximately $17 million are recorded in Cost of sales, approximately $9 million are recorded in Research and development, and $7 million in Other (income) expense, net. For the three months ended December 31, 2020, $95 million of the one-time costs are classified in Selling, general and administrative expenses.
For the twelve months ended December 31, 2021, approximately $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), approximately $45 million are recorded in Cost of sales, $14 million are recorded in Research and development, and $7million are recorded in Other (income) expense, net. For the twelve months ended December 31, 2020, $126 million of one-time costs are classified in Selling, general and administrative expenses.
(3) Costs represent $79 million related to the Forendo acquisition in the fourth quarter 2021 and the twelve month period for 2021 includes the $25 million upfront licensing payment associated with ObsEva in the third quarter 2021, both of which were recorded in Research and development expense.
(4) For the three months and twelve months 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.
Exhibit 99.2
Q4 and Full Year 2021 Earnings Organon
Disclaimer statement This text should be viewed in conjunction with Organon’s Full Year/ Q 4 2021 earnings call 2 Safe Harbor for Forward - Looking Statements Except for historical information herein, this news 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 mana gem ent’s expectations about Organon’s future financial performance and prospects. Forward - looking statements may be identified by words s uch as “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will” or words of similar meaning. These sta tem ents are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If u nde rlying 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 execute on our business development stra teg y or realize the benefits of our planned acquisitions; general industry conditions and competition; general economic factors, including intere st rate and currency exchange rate fluctuations; the impact of the ongoing COVID - 19 pandemic and emergence of variant strains; the impact of pharmace utical industry regulation and health care legislation in the United States and internationally; global trends toward health care co st containment; technological advances; new products and patents attained by competitors; challenges inherent in new product development, inc lud ing obtaining regulatory approval; the company’s ability to accurately predict its future financial results and performance; the com pany’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international eco nom ies and sovereign risk; difficulties developing and sustaining relationships with commercial counterparties; dependence on the effectiveness of th e company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or re gul atory actions. The company undertakes no obligation to publicly update any forward - looking statement, whether as a result of new information, futur e events or otherwise. Additional factors that could cause results to differ materially from those described in the forward - looking statemen ts can be found in the company’s filings with the Securities and Exchange Commission (SEC), including its registration statement on Form 10 and sub sequent periodic filings, available at the SEC’s Internet site (www.sec.gov).
Disclaimer statement, cont. Non - GAAP Information This presentation includes information based on financial measures that are not recognized under generally accepted accountin g p rinciples in the United States (“GAAP”), such as Adjusted EBITDA, Adjusted Net Income, and Adjusted Diluted Earnings per Share. Non - GAAP fina ncial measures are presented only as a supplement to the company’s financial statements based on GAAP. Non - GAAP financial information is provided to enhance understanding of the company’s financial performance, but none of these non - GAAP financial measures are reco gnized terms under GAAP, and non - GAAP measures should not be considered in isolation from, or as a substitute analysis for, the company ’s results of operations as determined in accordance with GAAP. The company uses non - GAAP measures in its operational and financial decisio n making and believes that it is useful to exclude certain items in order to focus on what it regards to be a more meaningful i ndi cator of the underlying operating performance of the business. The company also believes that investors may find non - GAAP financial measures useful for the same reasons, although investors are cautioned that non - GAAP financial measures are not a substitute for GAAP disclosures. T he non - GAAP financial measures are not presented in accordance with GAAP. Please refer to the appendix of this presentation for reco nci liations of non - GAAP financial measures contained herein to the most directly comparable GAAP measures. Our full - year 202 2 guidance measures (other than revenue) are provided on a non - GAAP basis because the company is unable to reasonably predict certain items contained in th e GAAP measures. Such items include, but are not limited to, acquisition related expenses, restructuring and related expenses, stock - ba sed compensation and other items not reflective of the company's ongoing operations. 3
$M Non - GAAP Guidance (as of 11/11/21) 2021 Full Year Actual Status Revenue $6,200 - $6,300 $6,304 Gross margin Low to mid - 60% range 64.7% Adjusted EBITDA margin 36.5% - 37.5% 37.7% Delivered on Year One expectations 4
Strong finish in 2021 • Growth engines ( Nexplanon ® etonogestrel implant , Fertility, and Biosimilars) all grew double digits in 2021 • Q4 2021 - Product sales show growth • Established Brands down 2% in Q4 2021 • Q4 Nexplanon growth strongest in product’s history 5
Building Women’s Health portfolio Marvelon Œ and Mercilon Œ February 2022 Contraception Expanding contraception portfolio by recapturing commercial rights to certain currently marketed products in Asia Acquisition of Forendo Pharma Completed in December 2021 Endometriosis Affects up to 170 million patients , or up to 10% of women of reproductive age Licensing of investigational ebopiprant, being studied in pre - term labor July 2021 Pre - term labor 15 million babies (11.1% of all live births) born pre - term every year (1) Acquisition of Alydia Health/JADA® System June 2021 Postpartum hemorrhage O ne of the most common complications of birth, requiring pharmacologic treatment in up to 10% of mothers (2) (1) WHO Key Facts, 2018: https://www.who.int/news - room/fact - sheets/detail/preterm - birth (2) Widmer M et al. "Heat - Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth." N Engl J Med 2018; 379:743 - 752 6
Growth pillars delivered; Established Brands stabilized $ mil Q4 - 21 Q4 - 20 (pre - spin) Actual VPY Ex FX VPY 2021 (mid - year spin) 2020 (pre - spin) Actual VPY Ex FX VPY Women’s Health 415 390 6 % 6 % 1,612 1,555 4% 2% Biosimilars 118 103 15 % 14 % 424 330 28% 25% Est ablished Brands 1,037 1,062 ( 2 )% ( 2 )% 4,068 4,540 (10)% (13)% Other ( 1 ) 34 58 (42)% (70)% 20 0 10 7 87% 67% Total Revenue 1,604 1,613 (1)% (1)% 6,304 6,532 (3)% (6)% 7 (1) Other includes manufacturing sales to Merck & Co., Inc.(“Merck”) and other third parties, and allocated amounts from pre - spin re venue hedging activities through the date of separation.
( 1 %) reported (1%) ex - FX ~10 $ mil $1,604 $1,613 ~35 ~50 ~20 ~70 ~30 ~10 Q4 revenue: volume mostly offsets VBP and LOE (1) Other includes manufacturing sales to Merck and other third parties, and allocated amounts from pre - spin revenue hedging activit ies through the date of separation. 8 (1)
Women’s Health Women’s Health Revenues $ mil Q 4 - 21 Q 4 - 20 Act VPY Ex FX VPY 2021 2020 Act VPY Ex FX VPY N explanon ® 226 165 37% 37% 769 680 13% 12% Follistim ® 59 57 4% 3% 237 193 23% 19% N uvaRing ® 44 53 (17)% (17)% 191 236 (19)% (21)% g anirelix a cetate 26 25 2% 1% 111 81 37% 32% Cerazette Œ 18 16 11% 12% 70 67 5% 3% Other 42 74 (44)% (43)% 234 298 (22)% (23)% Women's Health 415 390 6% 6% 1,612 1,555 4% 2% 9 • Record Nexplanon sales in Q4 2021 • Executing on BD strategy in WH • Strong full year growth in F ertility
Biosimilars Biosimilars Revenues $ mil Q 4 - 21 Q 4 - 20 Act VPY Ex FX VPY 2021 2020 Act VPY Ex FX VPY Renflexis ® 51 39 30% 29% 186 135 37% 36% Ontruzant ® 26 37 (31)% (30)% 126 115 10% 7% Brenzys Œ 28 23 24% 22% 63 74 (15)% (20)% Other 13 4 NM NM 49 6 NM NM Biosimilars 118 103 15% 14% 424 330 28 % 25 % 10 • Renflexis ® – continues to show strong growth four years post launch • Ontruzant growth in US tempered by EU competition and Brazil tender timing • Aybintio® and Hadlima ® – launched ex - US
Established Brands Revenue up/down Established B rands Revenues $ mil Q 4 - 21 Q 4 - 20 Act VPY Ex FX VPY 2021 2020 Act VPY Ex FX VPY Cardiovascular 398 434 (8)% (8)% 1,616 1,873 (14)% (17)% Respiratory 273 272 - 1% 1,009 1,151 (12)% (14)% Non - Opioid P ain, Bone & Derm. 208 199 4% 5% 830 833 - (4)% Other 158 157 1% 2% 613 683 (10)% (14)% Total Est. Brands 1,037 1,062 (2)% (2)% 4,068 4,540 (10)% (13)% 11 • Stabilization of revenue in Q4 2021 • Limited LOE headwind s going forward • China retail growth up double digits
$ mil 2021 (mid - year spin) 2020 (pre - spin) Actual VPY Ex FX VPY Europe and Canada 1,741 1,726 1 % ( 4 )% United States 1,383 1,408 ( 2 )% ( 2 )% Asia Pacific and Japan 1,173 1,535 ( 24 )% ( 25 )% China 933 873 7 % (1) % Latin America, Middle East, Russia and Africa 841 857 (2) % (2)% Other (1) 233 133 76% 60% Revenue 6,304 6,532 ( 3 )% ( 6 )% Solid performance in China despite VBP headwinds ~ 75% of sales generated ex - US 12 (1) Other includes manufacturing sales to Merck and other third parties, and allocated amounts from pre - spin revenue hedging activit ies through the date of separation.
FY 2021 performance in line with expectations $ mil (except EPS) Q 4 - 21 Q 4 - 20 (pre - spin) Actual VPY 2021 (mid - year spin) 2020 (pre - spin) Actual VPY Revenue 1,604 1,613 (1)% 6,304 6,532 (3)% Cost of sales 599 586 2% 2,382 2,119 12% Gross profit 1,005 1,027 (2)% 3,922 4,413 (11)% Gross margin 62.7% 63.7% 62.2% 67.6% Non - GAAP a djusted g ross profit (1) 1,059 1,051 1% 4,081 4,516 (10)% N on - GAAP a djusted g ross margin 66.0% 65.2% 64.7% 69.1% Selling, general, and administrative 481 434 11% 1,668 1,356 23% Research and development 189 60 215% 443 210 111% Adjusted EBITDA (2) 549 680 (19)% 2,379 3,120 (24)% Adjusted EBITDA m argin 34.2% 42.2% 37.7% 47.8% Net income, continuing operations (3) 202 376 (46)% 1,351 2,256 (40)% Diluted EPS 0.79 1.48 (47)% 5.31 8.90 (40)% Non - GAAP a djusted net income, continuing operations (3) 349 494 (29)% 1,662 2,523 (34)% Non - GAAP a djusted diluted EPS 1.37 1.95 (30)% 6.54 9.95 (34)% (1) See Slide 20 of this presentation for a reconciliation of g ross p rofit to a djusted g ross p rofit (2) See Slides 21 and 22 of this presentation for a reconciliation of EBITDA and a djusted EBITDA measures (3) See Slides 2 3 and 2 4 of this presentation for a reconciliation of n et i ncome from continuing operations to a djusted net income from continuing operations 13
14 $ mil $100 million voluntary debt repayment in Q4 – net leverage as of December 31, 2021 ~3.5x Lowered leverage in 2021 June 30, 2021 September 30, 2021 December 31,2021 Reported c ash and c ash equivalents 730 1,008 737 Cash from Merck for IOM - exit inventory (1) (400) (320) (0) Cash available to Organon 330 688 737 Gross Debt (2) 9,348 9,298 9,134 Net Debt (2) 9,018 8,610 8,397 (1) Organon’s starting cash balance at spin included $400 million from Merck, which was used for the purchase of inventory from Merck upon exit of certain Interim Operating Model arrangements. (2) Debt figures are net of discounts and unamortized fees of $135 million, $130 million, and $124 million as of June 30, 2021, S ept ember 30, 2021, and December 31, 2021, respectively.
2021 an inflection year for performance (3%) reported (6%) ex - FX $ mil $6,532 $6,304 ~300 ~170 ~140 ~190 ~80 ~130 ~20 (1) (1) Other includes manufacturing sales to Merck and other third parties, and allocated amounts from pre - spin revenue hedging activit ies through the date of separation. 15
Volume growth can more than offset business headwinds at constant currency $6,304 $6,100 – $6,400 ~(100) ~(100) ~(200 ) +600 − +700 (100) − (200) (100) − (200 ) $ millions (2) FX ~200 - 300 bps headwind to growth in 2022 (1) Other includes manufacturing sales to Merck and other third parties, and allocated amounts from pre - spin revenue hedging activit ies through the date of separation. (2) Based on 2021 performance and December month end spot rates for 2022. (1) 16
2022 Guidance: Investing for future growth 17 $M, provided on a Non - GAAP basis, except Revenue FY 2021 guidance as of November 11, 2021 2021 Actuals 2022 Guidance Revenue $6,200 - $6,300 6,304 $6,100 - $6,400 Adjusted gross margin Low to mid - 60% range 64.7% Mid - 60% range SG&A (as % of revenue) Mid - 20% range 23.8% Mid - 20% range R&D (as % of revenue) Mid - single - digit 5.2% Mid - upper single - digit Adjusted EBITDA margin 36.5% - 37.5% 37.7% 34% - 36% Interest expense ~$400 $100/qtr. pro forma ~$400 Depreciation $100 - $115 $92 $100 - $115 Effective non - GAAP tax rate 17.5% - 19.5% 18.1% 17.5% - 19.5% Fully diluted weighted avg. shares outstanding ~254M ~254M ~255M
Q&A
Appendix
Gross margin reconciliation $ mil Q4 - 21 Q4 - 20 (pre - spin) 2021 (mid - year spin) 2020 (pre - spin) Revenue 1,604 1,613 6,304 6,532 Cost of sales 599 586 2,382 2,119 Gross p rofit 1,005 1,027 3,922 4,413 Gross m argin 62.7% 63.7% 62.2% 67.6% Amortization 34 21 103 86 One - time costs (1) 17 - 45 - Stock - based compensation 3 3 11 17 Non - GAAP a djusted g ross p rofit (2) 1,059 1,051 4,081 4,516 Non - GAAP a djusted g ross m argin 66.0% 65.2% 64.7% 69.1% (1) 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 twelve month period ended December 31, 2021, one time costs include inventory discards related to separation re - labeling and other costs to stand up the Company. (2) Non - GAAP adjusted gross profit is calculated by excluding amortization, one - time costs described above, and the portion of stock - based compensation expense allocated to Cost of sales. 20
Net Income to Adjusted EBITDA reconciliation $ mil Q4 - 21 Q4 - 20 (pre - spin) Net income from continuing operations before income tax 236 525 Depreciation 28 14 Amortization (1) 34 21 Interest expense 98 - EBITDA 396 560 Restructuring costs - 17 One - time costs (2) 59 95 Acquired in - process research and development (3) 79 - Stock - based compensation 15 8 Adjusted EBITDA 549 680 Adjusted EBITDA margin 34.2% 42.2% (1) Amortization in all periods is included in Cost of sales. (2) For the three months ended December 31, 2021, one - time costs primarily include costs incurred in connection with the spin - off of Organon as well as $5 million of transaction costs pertaining to the Forendo acquisition and a $7 million impairment charge of a licensed intangible asset. For the three months ended December 31, 2021, approximately $26 million of the one - time c osts are recorded in Selling, general and administrative expenses, approximately $17 million are recorded in Cost of sales, approximately $9 million are recorded in Research and development, and $7 million in Other (income) expense, net. For the three months ended December 31, 2020, $95 million of the one - time costs are classified in Selling, general and administrative expenses. (3) Costs represent $79 million related to the Forendo acquisition in the fourth quarter 2021, which was recorded in Research and de velopment expense. 21
Net Income to Adjusted EBITDA reconciliation $ mil 2021 (mid - year spin) 2020 (pre - spin) Net income from continuing operations before income tax 1,529 2,752 Depreciation 92 56 Amortization (1) 103 86 Interest expense 258 - EBITDA 1,982 2,894 Restructuring costs 3 60 One - time costs (2) 231 126 Acquired in - process research and development (3) 104 - Stock - based compensation 59 40 Adjusted EBITDA 2,379 3,120 Adjusted EBITDA margin 37.7% 47.8% (1) Amortization in all periods is included in Cost of sales. (2) For the twelve months ended December 31, 2021, approximately $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), approximately $45 million are recorded in Cost of sales, $14 million are recorded in Research and development, an d $7 million are recorded in Other (income) expense, net. For the twelve months ended December 31, 2020, $126 million of one - time costs are classified in Selling, general and administrative expenses. (3) Costs represent $79 million related to the Forendo acquisition in the fourth quarter 2021 and the twelve month period for 202 1 i ncludes the $25 million upfront licensing payment associated with ObsEva in the third quarter 2021, both of which were recorded in Research and development expense. 22
Net Income to Adjusted Net Income reconciliation $ mil (except EPS) Q4 - 21 Q4 - 20 (pre - spin) Net income from continuing operations before income tax 236 525 Amortization (1) 34 21 Restructuring costs - 17 One - time costs (2) 59 95 Acquired in - process research and development (3) 79 - Stock - based compensation 15 8 Total Adjustments 187 141 Non - GAAP pre - tax income from continuing operations 423 666 Taxes on income as reported in accordance with GAAP 34 149 Tax benefit on adjustments 35 23 Tax benefit on GAAP - only discrete items (4) 5 - Non - GAAP adjusted taxes on income 74 172 Non - GAAP adjusted net income, continuing operations 349 494 Non - GAAP adjusted net income, continuing operations per diluted share 1.37 1.95 (1) Amortization in all periods is included in Cost of sales. (2) For the three months ended December 31, 2021, one - time costs primarily include costs incurred in connection with the spin - off of Organon as well as $5 million of transaction costs pertaining to the Forendo acquisition and a $7 million impairment charge of a licensed intangible asset. For the three months ended December 31, 2021, approximately $26 million of the one - time costs ar e recorded in Selling, general and administrative expenses, approximately $17 million are recorded in Cost of sales, approximately $9 million are recorded in Research and development, and $7 million in Other (income) expense, net. For the thr ee months ended December 31, 2020, $95 million of the one - time costs are classified in Selling, general and administrative expenses. (3) Costs represent $79 million related to the Forendo acquisition in the fourth quarter 2021, which was recorded in Research and de velopment expense. (4) For the three months ended December 31, 2021, the company recorded a tax benefit of approximately $5 million related to a por tio n of non - US step up in tax basis as a result of its separation from Merck. 23
Net Income to Adjusted Net Income reconciliation $ mil (except EPS) 2021 (mid - year spin) 2020 (pre - spin) Net income from continuing operations before income tax 1,529 2,752 Amortization (1) 103 86 Restructuring costs 3 60 One - time costs (2) 231 126 Acquired in - process research and development (3) 104 - Stock - based compensation 59 40 Total Adjustments 500 312 Non - GAAP pre - tax income from continuing operations 2,029 3,064 Taxes on income as reported in accordance with GAAP 178 496 Tax benefit on adjustments 93 45 Tax benefit on GAAP - only discrete items (4) 96 - Non - GAAP adjusted taxes on income 367 541 Non - GAAP adjusted net income, continuing operations 1,662 2,523 Non - GAAP adjusted net income, continuing operations per diluted share 6.54 9.95 (1) Amortization in all periods is included in Cost of sales. (2) For the twelve month period ended December 31, 2021, approximately $165 million of the one - time costs are recorded in Selling, g eneral and administrative expenses (which includes $23 million pertaining to the acquisition of Alydia in the second quarter 2021), approximately $45 million are recorded in Cost of sales, $14 million are recorded in Research and development, an d $7 million are recorded in Other (income) expense, net. For the twelve months ended December 31, 2020, $126 million of one - time costs are classified in Selling, general and administrative expenses. (3) Costs represent $79 million related to the Forendo acquisition in the fourth quarter 2021 and the twelve month period for 202 1 i ncludes the $25 million upfront licensing payment associated with ObsEva in the third quarter 2021, both of which were recorded in Research and development expense. (4) For the twelve month period ended December 31, 2021, the company recorded a tax benefit of approximately $75 million related to a portion of non - US step up in tax basis as a result of its separation from Merck. 24
Number of products 11 5 49 Women’s Health Biosimilars Established Brands Broad and diverse portfolio 25 ® Œ