8-K
Organon & Co. (OGN)
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UNITED STATESSECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the SecuritiesExchange Act of 1934
Date of Report (Date
of earliest event reported): August 4, 2022
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<br>Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange<br>Act (17 CFR 240.14a-12) |
| --- | --- |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under<br>the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under<br>the Exchange Act (17 CFR 240.13e-4(c)) |
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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. |
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On August 4, 2022, Organon & Co. (the “Company”) issued a press release (the “Earnings Release”) regarding its results for the quarter ended June 30, 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. |
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In connection with the conference call announced in the Earnings Release, on August 4, 2022, the Company made available the Company Information Presentation relating to its financial results for the quarter ended June 30, 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 August 4, 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: August 4, 2022
Exhibit 99.1
| Media Contacts: | Karissa Peer | Investor Contacts: | Jennifer Halchak |
|---|---|---|---|
| (614) 314-8094<br><br> <br><br><br> <br>Kate Vossen<br><br> <br>(732) 675-8448 | (201) 275-2711<br><br> <br><br><br> <br>Edward Barger<br><br> <br>(267) 614-4669 |
Organon reports results for the second quarterended June 30, 2022
| · | Second quarter 2022 revenues of $1,585 million |
|---|---|
| · | Second quarter diluted earnings per share from continuing operations of $0.92 and non-GAAP adjusted diluted earnings per share from<br>continuing operations of $1.25 |
| · | Both reported and non-GAAP adjusted diluted earnings per share include a negative impact of $0.30 for acquired in-process research<br>and development (IPR&D) and milestones |
| · | Adjusted EBITDA of $512 million, inclusive of $97 million of acquired IPR&D and milestones |
| · | Board of Directors declares quarterly dividend of $0.28 per share |
| · | Full year 2022 financial guidance ranges updated: |
| ◦ | Revenues range narrowed to $6.1 billion to $6.3 billion, and reflects persisting foreign currency headwinds |
| --- | --- |
| ◦ | Adjusted EBITDA margin range now 32%-34% to incorporate acquired IPR&D and milestone expenses from recent business development |
Jersey City, N.J., August 4, 2022 – Organon (NYSE: OGN) (the “company”), today announced its results for the second quarter ended June 30, 2022.
"During the second quarter, Organon delivered constant currency growth across all our reported geographies and in all three franchises. Our Established Brands franchise grew in almost every therapy area, demonstrating the sustainability and untapped potential of these brands," said Kevin Ali, Organon's Chief Executive Officer. "Additionally, we continued to invest for growth during the quarter adding Shanghai Henlius Biotech as another R&D and manufacturing collaborator for biosimilars, underscoring our commitment to this business. And importantly, we further expanded our offerings in Women's Health recently signing a research collaboration with Cirqle Biomedical for a novel investigational non-hormonal, on-demand contraceptive candidate."
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Second quarter 2022 revenues
| in $ millions | Q2 2022 | Q2 2021 | VPY | VPY ex-FX | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Women’s Health | $ | 408 | $ | 417 | (2 | )% | 1 | % | ||
| Biosimilars | 119 | 86 | 39 | % | 42 | % | ||||
| Established Brands | 1,018 | 1,045 | (2 | )% | 4 | % | ||||
| Other ^(1)^ | 40 | 47 | (17 | )% | (18 | )% | ||||
| Revenues | $ | 1,585 | $ | 1,595 | (1 | )% | 5 | % |
*^(1)^*Otherincludes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties, and allocated amounts from pre-spinrevenue hedging activities.
Total net revenues were $1,585 million for the second quarter of 2022, a decrease of 1% as-reported and an increase of 5% excluding the impact of foreign currency (ex-FX), compared with the second quarter of 2021.
Women’s Health declined 2% as-reported, but increased 1% ex-FX in the second quarter of 2022 compared with the second quarter of 2021. During the second quarter of 2022, Nexplanon® (etonogestrel implant) grew 8% ex-FX, primarily driven by favorable pricing and demand uptake in the United States and volume growth outside the United States. Nuvaring® (etonogestrel/ethinyl estradiol vaginal ring) continues to be impacted by generic competition and declined 18% ex-FX in the second quarter of 2022 compared with the prior year period. Follistim AQ® (follitropin beta injection), declined 9% ex-FX in the second quarter of 2022, primarily due to COVID-related disruptions in China and an unfavorable channel mix in the United States, that offset solid demand.
Biosimilars revenue grew 39% as-reported and 42% ex-FX in the second quarter 2022 compared with the second quarter of 2021. Organon's current portfolio includes certain immunology and oncology treatments. All five of the biosimilars in Organon’s portfolio have launched in certain countries globally, including two biosimilars, Renflexis® (infliximab-abda) and Ontruzant® (trastuzumab-dttb), in the United States. Renflexis grew 39% ex-FX in the second quarter of 2022 compared with the prior year period, primarily due to continued demand growth in the United States since its launch in 2017. Ontruzant grew 61% ex-FX driven by timing of an order in Brazil, as well as continued uptake in the United States since its launch in July 2020, partially offset by increased competition in Europe.
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. The portfolio's exposure to loss of exclusivity (LOE) risk peaked in 2021 and no longer represents a significant impediment to stable performance in the Established Brands franchise. Revenues for Established Brands decreased 2% as-reported and increased 4% ex-FX in the second quarter of 2022 compared with the second quarter of 2021. During the second quarter of 2022, the cardiovascular portfolio grew 3% ex-FX primarily driven by strong Atozet ^TM^ (ezetimibe and atorvastatin calcium) sales in Europe and Cozaar® (losartan potassium) /Hyzaar® (losartan potassium and hydrochlorothiazide) sales in China. The Established Brands franchise also benefited from a continuation of a temporary supply disruption affecting several competitors in the Japanese market, most notably in the respiratory portfolio. Year to date, the franchise has not experienced significant impacts from the implementation of Volume Based Procurement (VBP) in China, which the company expects will be more pronounced in the second half of 2022. Still, based on the strong year to date performance, the company expects the Established Brands franchise to deliver relatively flat constant currency revenue growth for the full year 2022.
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Second quarter 2022 profitability
Organon was spun-off from Merck & Co., Inc., Rahway, NJ, USA on June 2, 2021. Financial results during the pre-spin period were presented on the carve-out basis of accounting and do not purport to reflect what Organon’s financial results would have been had Organon operated as a standalone public company. Therefore, with the exception of revenue, financial results for the periods ending June 30, 2022 and June 30, 2021 are not meaningfully comparable.
| in $ millions, except per share amounts | Q2 2022 | Q2 2021<br><br>mid-year spin | VPY | |||||
|---|---|---|---|---|---|---|---|---|
| Revenues | $ | 1,585 | $ | 1,595 | (1 | )% | ||
| Gross profit | 997 | 1,012 | (1 | )% | ||||
| Non-GAAP Adjusted Gross Profit ^(1)^ | 1,047 | 1,047 | — | % | ||||
| Adjusted EBITDA ^(1,2)^ | 512 | 627 | (18 | )% | ||||
| Net Income, continuing operations | 234 | 431 | (46 | )% | ||||
| Non-GAAP adjusted net income, continuing operations ^(1)^ | 319 | 437 | (27 | )% | ||||
| Diluted Earnings per Share (EPS), continuing operations | 0.92 | 1.70 | (46 | )% | ||||
| Non-GAAP adjusted diluted EPS, continuing operations ^(1)^ | 1.25 | 1.72 | (27 | )% | ||||
| Acquired IPR&D and milestones | 97 | — | NM | |||||
| Per share impact to diluted EPS from acquired IPR&D and milestones | (0.30 | ) | — | NM | ||||
| Q2 2022 | Q2 2021****mid-year spin | |||||||
| --- | --- | --- | --- | --- | ||||
| Gross margin | 62.9 | % | 63.4 | % | ||||
| Non-GAAP Adjusted Gross Margin ^(1)^ | 66.1 | % | 65.6 | % | ||||
| Adjusted EBITDA margin ^(1,2)^ | 32.3 | % | 39.3 | % |
*^(1)^*SeeTables 4,5 and 6 for reconciliations of GAAP to non-GAAP financial measures
*^(2)^*AdjustedEBITDA and Adjusted EBITDA margin include $97 million in the second quarter of 2022 related to acquired IPR&D and milestones
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Gross margin in the second quarter of 2022 was 62.9% as-reported, and comparable to 63.4% in the prior year period. Adjusted Gross Margin was 66.1% in the second quarter of 2022 compared with 65.6% on an adjusted basis in the second quarter of 2021.
Adjusted EBITDA margin was 32.3% in the second quarter of 2022 compared with 39.3% in the second quarter of 2021. Adjusted EBITDA margin in the second quarter of 2022 is inclusive of $97 million of acquired IPR&D and milestones. Higher R&D spend associated with the company's recent acquisitions of clinical stage assets as well as higher employee related costs contributed to the decline in Adjusted EBITDA margin year over year.
Net income from continuing operations for the second quarter of 2022 was $234 million, or $0.92 per diluted share, compared with $431 million, or $1.70 per diluted share, in the second quarter of 2021. Non-GAAP Adjusted net income from continuing operations was $319 million, or $1.25 per diluted share, compared with $437 million, or $1.72 per diluted share, in 2021.
Beginning in 2022, Organon will no longer exclude expenses for upfront and milestone payments related to collaborations and licensing agreements, or charges related to pre-approval assets obtained in transactions accounted for as asset acquisitions from its non-GAAP results. The change to include all acquired IPR&D and milestone expenses negatively impacted Adjusted diluted EPS by $0.30 in the second quarter of 2022. There was no similar impact in the second quarter of 2021. In connection with this change, acquired IPR&D expenses are now reported as a separate income statement line item. These costs were previously recorded within the R&D expenses line. Prior period amounts have been revised to conform to the current period presentation.
Capital allocation
Today, Organon’s Board of Directors declared a quarterly dividend of $0.28 for each issued and outstanding share of the company's common stock. The dividend is payable on September 15, 2022 to stockholders of record at the close of business on August 15, 2022.
As of June 30, 2022, cash and cash equivalents were $545 million, and debt was $8.9 billion. Total debt as of June 30, 2022 reflects a discretionary second quarter prepayment of $100 million on the company’s U.S. dollar denominated term loan.
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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 updating its full year 2022 guidance ranges previously provided on May 5, 2022. The range for full year 2022 revenue is narrowed to $6.1 billion to $6.3 billion, which reflects persisting foreign exchange headwinds. The range for full year Adjusted EBITDA margin is now 32% to 34% to incorporate approximately $110 million of IPR&D and milestone expenses from business development through August 4, 2022. Organon's financial guidance does not assume an estimate for future IPR&D and milestone payments for business development transactions not yet executed.
| Previous guidance | IPR&D | Current guidance | |
|---|---|---|---|
| Revenues | 6.1B - 6.4B | $6.1B - $6.3B | |
| Adjusted Gross margin | Mid 60% | Unchanged | |
| SG&A (as % of revenue) | Mid 20% | Unchanged | |
| R&D (as % of revenue) | Mid-upper single digit | Upper single-digit | |
| Adjusted EBITDA margin | 34%-36% | ~($110)M | 32% - 34% |
| Interest | ~400 million | Unchanged | |
| Depreciation | 100-115 million | Unchanged | |
| Effective Non-GAAP tax rate | 17.5%-19.5% | Unchanged | |
| Fully diluted weighted avg. shares outstanding | ~255 million | Unchanged |
All values are in US Dollars.
Webcast Information
Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its second quarter 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/. 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# 58511-993 and 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.
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About Organon
Organon is a global healthcare company formed 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 9,300 employees with headquarters located in Jersey City, New Jersey.
For more information, visit http://www.organon.com and connect with us on LinkedIn and Instagram.
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. 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.
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In addition, 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.
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.
Forward-Looking Statement
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.
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 economic factors, including 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.
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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, 2021 and subsequent SEC filings, 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 June 30, | Six Months Ended June 30, | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | 2022 | 2021 | ||||||||
| Revenues | $ | 1,585 | $ | 1,595 | $ | 3,152 | $ | 3,101 | |||
| Costs, Expenses and Other | |||||||||||
| Cost of sales | 588 | 583 | 1,149 | 1,174 | |||||||
| Selling, general and administrative | 423 | 416 | 794 | 798 | |||||||
| Research and development | 106 | 76 | 202 | 143 | |||||||
| Acquired in-process research and development and milestones | 97 | — | 97 | — | |||||||
| Restructuring costs | — | 1 | — | 2 | |||||||
| Interest expense | 98 | 62 | 195 | 62 | |||||||
| Other (income) expense, net | (14 | ) | 20 | (14 | ) | 18 | |||||
| 1,298 | 1,158 | 2,423 | 2,197 | ||||||||
| Income From Continuing Operations Before Income Taxes | 287 | 437 | 729 | 904 | |||||||
| Taxes on Income | 53 | 6 | 147 | 78 | |||||||
| Net Income From Continuing Operations | 234 | 431 | 582 | 826 | |||||||
| Loss From Discontinued Operations - Net of Tax | — | (4 | ) | — | — | ||||||
| Net Income | 234 | 427 | 582 | 826 | |||||||
| Earnings (Loss) per Share Attributable to Organon & Co. Stockholders - Basic: | |||||||||||
| Continuing operations | $ | 0.92 | $ | 1.70 | $ | 2.29 | $ | 3.26 | |||
| Discontinued operations | — | (0.02 | ) | — | — | ||||||
| Net Earnings per Share Attributable to Organon & Co. Stockholders | $ | 0.92 | $ | 1.68 | $ | 2.29 | $ | 3.26 | |||
| Earnings (Loss) per Share Attributable to Organon & Co. Stockholders - Diluted: | |||||||||||
| Continuing operations | $ | 0.92 | $ | 1.70 | $ | 2.28 | $ | 3.25 | |||
| Discontinued operations | — | (0.02 | ) | — | — | ||||||
| Net Earnings per Share Attributable to Organon & Co. Stockholders | $ | 0.92 | $ | 1.68 | $ | 2.28 | $ | 3.25 | |||
| Weighted Average Shares Outstanding: | |||||||||||
| Basic | 254,018 | 253,516 | 253,802 | 253,516 | |||||||
| Diluted | 255,156 | 253,828 | 255,105 | 253,828 |
TABLE 2
Organon & Co.
Sales by top products
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | $ | 134 | $ | 61 | $ | 195 | $ | 129 | $ | 56 | $ | 184 | $ | 250 | $ | 116 | $ | 366 | $ | 269 | $ | 98 | $ | 368 | ||
| Follistim AQ | 23 | 35 | 58 | 27 | 38 | 65 | 52 | 66 | 119 | 52 | 65 | 117 | ||||||||||||||
| NuvaRing | 22 | 20 | 42 | 26 | 28 | 53 | 38 | 45 | 83 | 47 | 52 | 98 | ||||||||||||||
| Ganirelix Acetate Injection | 6 | 25 | 32 | 5 | 25 | 31 | 14 | 47 | 61 | 14 | 46 | 60 | ||||||||||||||
| Cerazette | — | 15 | 15 | — | 18 | 18 | — | 32 | 32 | — | 34 | 34 | ||||||||||||||
| Other Women's Health ^(1)^ | 29 | 38 | 67 | 23 | 43 | 66 | 56 | 69 | 125 | 63 | 76 | 139 | ||||||||||||||
| Biosimilars | ||||||||||||||||||||||||||
| Renflexis | 51 | 8 | 59 | 36 | 7 | 43 | 93 | 12 | 105 | 70 | 11 | 81 | ||||||||||||||
| Ontruzant | 12 | 23 | 35 | 7 | 15 | 22 | 19 | 38 | 57 | 11 | 34 | 45 | ||||||||||||||
| Brenzys | — | 14 | 14 | — | 11 | 11 | — | 28 | 28 | — | 21 | 21 | ||||||||||||||
| Aybintio | — | 9 | 9 | — | 8 | 8 | — | 19 | 19 | — | 16 | 16 | ||||||||||||||
| Hadlima | — | 2 | 2 | — | 2 | 2 | — | 8 | 8 | — | 4 | 4 | ||||||||||||||
| Established Brands | ||||||||||||||||||||||||||
| Cardiovascular | ||||||||||||||||||||||||||
| Zetia | 2 | 99 | 101 | 2 | 97 | 99 | 5 | 195 | 200 | 4 | 186 | 190 | ||||||||||||||
| Vytorin | 3 | 32 | 35 | 2 | 42 | 45 | 5 | 68 | 73 | 5 | 81 | 86 | ||||||||||||||
| Atozet | — | 122 | 122 | — | 121 | 121 | — | 240 | 240 | — | 233 | 233 | ||||||||||||||
| Rosuzet | — | 16 | 16 | — | 18 | 18 | — | 38 | 38 | — | 33 | 33 | ||||||||||||||
| Cozaar/Hyzaar | 2 | 91 | 92 | 2 | 84 | 86 | 10 | 176 | 186 | 6 | 171 | 177 | ||||||||||||||
| Other Cardiovascular ^(1)^ | 1 | 45 | 46 | 1 | 60 | 61 | 2 | 83 | 85 | 2 | 98 | 100 | ||||||||||||||
| Respiratory | ||||||||||||||||||||||||||
| Singulair | 3 | 89 | 92 | 3 | 89 | 92 | 5 | 216 | 222 | 8 | 191 | 199 | ||||||||||||||
| Nasonex | — | 58 | 58 | 1 | 51 | 52 | 9 | 123 | 133 | 3 | 92 | 95 | ||||||||||||||
| Dulera | 36 | 12 | 47 | 42 | 10 | 52 | 67 | 21 | 88 | 73 | 18 | 91 | ||||||||||||||
| Clarinex | 1 | 34 | 35 | 2 | 29 | 30 | 2 | 70 | 73 | 3 | 52 | 55 | ||||||||||||||
| Other Respiratory ^(1)^ | 11 | 11 | 22 | 13 | 9 | 22 | 23 | 22 | 45 | 29 | 15 | 44 | ||||||||||||||
| Non-Opioid Pain, Bone and Dermatology | ||||||||||||||||||||||||||
| Arcoxia | — | 61 | 61 | — | 62 | 62 | — | 121 | 121 | — | 119 | 119 | ||||||||||||||
| Fosamax | 1 | 39 | 40 | 1 | 48 | 49 | 2 | 79 | 81 | 2 | 85 | 86 | ||||||||||||||
| Diprospan | — | 31 | 31 | — | 32 | 32 | — | 63 | 63 | — | 57 | 57 | ||||||||||||||
| Other Non-Opioid Pain, Bone and Dermatology ^(1)^ | 5 | 71 | 76 | 4 | 72 | 75 | 8 | 137 | 145 | 3 | 133 | 136 | ||||||||||||||
| Other | ||||||||||||||||||||||||||
| Proscar | — | 26 | 26 | — | 31 | 32 | 1 | 50 | 50 | 1 | 63 | 64 | ||||||||||||||
| Propecia | 2 | 33 | 35 | 2 | 34 | 36 | 3 | 63 | 66 | 4 | 63 | 67 | ||||||||||||||
| Other ^(1)^ | 7 | 74 | 82 | 13 | 68 | 81 | 15 | 149 | 164 | 24 | 146 | 169 | ||||||||||||||
| Other ^(2)^ | — | 40 | 40 | (2 | ) | 49 | 47 | 1 | 78 | 76 | (3 | ) | 119 | 117 | ||||||||||||
| Revenues | $ | 351 | $ | 1,234 | $ | 1,585 | $ | 339 | $ | 1,257 | $ | 1,595 | $ | 680 | $ | 2,472 | $ | 3,152 | $ | 690 | $ | 2,412 | $ | 3,101 |
Totals maynot foot due to rounding. Trademarks appearing above in italics are trademarks of, or are used under license by, the Organon group ofcompanies.
| ^(1)^ | Includes sales of products not listed separately. Revenuefrom 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 June 30, | Six Months Ended June 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| ($ in millions) | 2022 | 2021 | 2022 | 2021 | ||||
| Europe and Canada | $ | 443 | $ | 470 | $ | 880 | $ | 904 |
| United States | 351 | 339 | 680 | 690 | ||||
| Asia Pacific and Japan | 291 | 309 | 604 | 587 | ||||
| China | 244 | 236 | 480 | 442 | ||||
| Latin America, Middle East, Russia and Africa | 216 | 190 | 425 | 357 | ||||
| Other ^(1)^ | 40 | 51 | 83 | 121 | ||||
| Revenues | $ | 1,585 | $ | 1,595 | $ | 3,152 | $ | 3,101 |
| ^(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-GAAPAdjusted Gross Profit and Adjusted Gross Margin
($ in millions)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Revenues | $ | 1,585 | $ | 1,595 | $ | 3,152 | $ | 3,101 | ||||
| Cost of sales | 588 | 583 | 1,149 | 1,174 | ||||||||
| Gross Profit | 997 | 1,012 | 2,003 | 1,927 | ||||||||
| Gross Margin | 62.9 | % | 63.4 | % | 63.5 | % | 62.1 | % | ||||
| Amortization | 28 | 22 | 56 | 42 | ||||||||
| One-time costs ^(1)^ | 19 | 10 | 24 | 10 | ||||||||
| Stock-based compensation | 3 | 3 | 6 | 5 | ||||||||
| Non-GAAP Adjusted Gross Profit ^(2)^ | $ | 1,047 | $ | 1,047 | 2,089 | 1,984 | ||||||
| Non-GAAP Adjusted Gross Margin | 66.1 | % | 65.6 | % | 66.3 | % | 64.0 | % | ||||
| ^(1)^ | One-time costs for the three and six months ended June 30,2022 primarily include costs to stand up the Company and inventory step-up adjustments as well as a $9 million impairment charge relatedto a licensed intangible asset. | |||||||||||
| --- | --- | |||||||||||
| ^(2)^ | Non-GAAP Adjusted Gross Profit is calculated by excludingamortization, one-time costs, and the portion of stock-based compensation expense allocated to Cost of sales. | |||||||||||
| --- | --- |
TABLE 5
Organon & Co.
Reconciliation of GAAP Income from ContinuingOperations Before Income Taxes to Adjusted EBITDA
($ in millions)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Income from continuing operations before income taxes | $ | 287 | $ | 437 | $ | 729 | $ | 904 | ||||
| Depreciation | 22 | 21 | 47 | 39 | ||||||||
| Amortization ^(1)^ | 28 | 22 | 56 | 42 | ||||||||
| Interest expense | 98 | 62 | 195 | 62 | ||||||||
| EBITDA | $ | 435 | $ | 542 | $ | 1,027 | $ | 1,047 | ||||
| Restructuring costs | — | 1 | — | 2 | ||||||||
| One-time costs ^(2)^ | 58 | 66 | 98 | 115 | ||||||||
| Stock-based compensation | 19 | 18 | 34 | 29 | ||||||||
| Adjusted EBITDA | $ | 512 | $ | 627 | $ | 1,159 | $ | 1,193 | ||||
| Adjusted EBITDA margin | 32.3 | % | 39.3 | % | 36.8 | % | 38.5 | % | ||||
| ^(1)^ | Amortization in all periods is included in Cost of sales. | |||||||||||
| --- | --- | |||||||||||
| ^(2)^ | One-time costs primarily include costs incurred in connectionwith the spin-off of Organon, an impairment of a licensed intangible asset, and inventory step up adjustments. For the three months endedJune 30, 2022, approximately $28 million of the one-time costs are recorded in Selling, general and administrative expenses, $19million are recorded in Cost of sales, $8 million are recorded in Other (income) expense, and $3 million are recorded in Research anddevelopment. For the three months ended June 30, 2021, approximately $55 million of the one-time costs are recorded in Selling,general and administrative expenses, and approximately $10 million are recorded in Cost of sales. | |||||||||||
| --- | --- | |||||||||||
| ^(2)^ | One-time costs primarily include costs incurred in connectionwith the spin-off of Organon, an impairment of a licensed intangible asset, and inventory step-up adjustments. For the six months endedJune 30, 2022, approximately $53 million of the one-time costs are recorded in Selling, general and administrative expenses, approximately$24 million are recorded in Cost of sales, $14 million are recorded in Other (income) expense, and $7 million are recorded in Researchand development. For the six months ended June 30, 2021, approximately $104 million of the GAAP one-time costs are recorded in Selling,general and administrative expenses, and approximately $10 million are recorded in Cost of sales. | |||||||||||
| --- | --- |
TABLE 6
Organon & Co.
Reconciliation of GAAP Income from ContinuingOperations Before Income Taxes to Non-GAAP Adjusted Net Income
($ in millions, except per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | 2022 | 2021 | ||||||
| Income from continuing operations before income taxes | $ | 287 | $ | 437 | $ | 729 | $ | 904 | |
| Adjustments: | |||||||||
| Amortization ^(1)^ | 28 | 22 | 56 | 42 | |||||
| Restructuring costs | — | 1 | — | 2 | |||||
| One-time costs ^(2)^ | 58 | 66 | 98 | 115 | |||||
| Stock-based compensation | 19 | 18 | 34 | 29 | |||||
| Total Adjustments | 105 | 107 | 188 | 188 | |||||
| Non-GAAP pre-tax income, continuing operations | $ | 392 | $ | 544 | $ | 917 | $ | 1,092 | |
| Taxes on income as reported in accordance with GAAP | 53 | 6 | 147 | 78 | |||||
| Tax benefit on adjustments | 20 | 20 | 34 | 35 | |||||
| Tax benefit (deduction) on GAAP-only discrete items ^(3)^ | — | 81 | (3 | ) | 91 | ||||
| Non-GAAP adjusted taxes on income | 73 | 107 | 178 | 204 | |||||
| Non-GAAP adjusted net income, continuing operations | $ | 319 | $ | 437 | $ | 739 | $ | 888 | |
| Non-GAAP adjusted net income, continuing operations per diluted share | $ | 1.25 | $ | 1.72 | $ | 2.90 | $ | 3.50 | |
| ^(1)^ | Amortization in all periods is included in Cost of sales. | ||||||||
| --- | --- | ||||||||
| ^(2)^ | One-time costs primarily include costs incurred in connectionwith the spin-off of Organon, an impairment of a licensed intangible asset, and inventory step-up adjustments. For the three months endedJune 30, 2022, approximately $28 million of the one-time costs are recorded in Selling, general and administrative expenses, $19million are recorded in Cost of sales, $8 million are recorded in Other (income) expense, and $3 million are recorded in Research anddevelopment. For the three months ended June 30, 2021, approximately $55 million of the one-time costs are recorded in Selling,general and administrative expenses, and approximately $10 million are recorded in Cost of sales. | ||||||||
| --- | --- | ||||||||
| ^(2)^ | One-time costs primarily include costs incurred in connectionwith the spin-off of Organon, an impairment of a licensed intangible asset, and inventory step-up adjustments. For the six months endedJune 30, 2022, approximately $53 million of the one-time costs are recorded in Selling, general and administrative expenses, approximately$24 million are recorded in Cost of sales, $14 million are recorded in Other (income) expense, and $7 million are recorded in Researchand development. For the six months ended June 30, 2021, approximately $104 million of the GAAP one-time costs are recorded in Selling,general and administrative expenses, and approximately $10 million are recorded in Cost of sales. | ||||||||
| --- | --- | ||||||||
| ^(3)^ | For the three months ended June 30, 2021, the companyrecorded a tax benefit of approximately $70 million related to a portion of non-U.S. step-up in tax basis as a result of its separationfrom Merck & Co., Inc., Rahway, NJ, USA. | ||||||||
| --- | --- |
Exhibit 99.2
Q2 2022 Earnings Organon
Disclaimer statement Safe Harbor for 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 expectati ons about Organon’s future financial performance and prospects. Forward - looking statements may be identified by words such as “expects,” “intends,” “antici pates,” “plans,” “believes,” “seeks,” “estimates,” “will” or words of similar meaning. These statements are based upon the current beliefs and ex pectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or ri sks or uncertainties materialize, actual results may differ materially from those set forth in the forward - looking statements. Risks and uncertaintie s include, but are not limited to, an inability to execute on our business development strategy or realize the benefits of our planned acquisitions; general ec onomic factors, including interest rate and currency exchange rate fluctuations; general industry conditions and competition; the impact of the ongoing CO VID - 19 pandemic and emergence of variant strains; the impact of pharmaceutical industry regulation and health care legislation in the United Stat es and internationally; global trends toward health care cost containment; technological advances; new products and patents attained by competitors; challen ges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict its future financia l r esults 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 effect ive ness of the 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, 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, 202 1 and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov). This text should be viewed in conjunction with Organon’s Q2 2022 earnings call 2
Disclaimer statement, cont. Non - GAAP Information 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. 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 no t be considered in isolation, or as a substitute for the company’s results as reported under GAAP. Because not all companies use i den tical calculations, the presentations of these non - GAAP measures may not be comparable to other similarly titled measures of other com panies. You should refer to the appendix of this presentation for relevant definitions and reconciliations of non - GAAP financial measures co ntained herein to the most directly comparable GAAP measures. In addition, the company’s full - year 2022 guidance measures (other than revenues) ar e provided on a non - GAAP basis because the company is unable to reasonably predict certain items contained in the GAAP measures. S uch items include, but are not limited to, acquisition related expenses, restructuring and related expenses, stock - based compensatio n and other items not reflective of the company's ongoing operations. The company uses non - GAAP financial measures in its operational and fi nancial decision making, and believes that it is useful to exclude certain items in order to focus on what it regards to be a more me ani ngful representation of the underlying operating performance of the business. 3
Second quarter 2022 highlights 4 • All franchises show growth Ex - FX • Improved trajectory for Established Brands • Expanded biosimilars portfolio with additional R&D collaborator; Shanghai Henlius Biotech Inc. • Revenues of $1,585 million • $512 million Adjusted EBITDA, inclusive of $97M in acquired IPR&D and milestones • $1.25 Adjusted EPS from continuing operations, inclusive of negative $0.30 impact from acquired IPR&D and milestones
Balancing commercial and pipeline business development Commercialized/soon to be commercialized assets Building a pipeline • March 2022 - Licensing agreement for Xaciato Œ • July 2022 - Licensing agreement for a novel investigational non - hormonal, on - demand contraceptive candidate with Cirqle Biomedical • February 2022 - Acquisition of commercial rights to Marvelon Œ and Mercilon Œ in certain Asian markets • June 2022 - Licensing agreement to commercialize Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) biosimilar candidates • June 2021 - Acq. of Alydia Health and its JADA® System • July 2021 - Licensing of investigational agent, ebopiprant • December 2021 - Acquisition of Forendo Pharma 5
- 1% reported +5% ex - FX $ mil 1,585 1,595 6 Solid volume growth, limited LOE and VBP impact (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, and allocated amounts from pre - spin revenue hedging activities. ~10 ~175 ~175 ~80 ~25 ~60 (3) (1) (2) ~0 FX ~ 500 bps impact
All geographic areas grew ex - FX $ mil Q2 - 22 Q2 - 21 (mid - year spin) Actual VPY Ex FX VPY Europe and Canada 443 470 (6)% 4% United States 351 339 4% 4% Asia Pacific and Japan 291 309 (6)% 4% China 244 236 3% 4% Latin America, Middle East, Russia and Africa 216 190 14% 16% Other (1) 40 51 (22)% (21)% Total Revenues 1,585 1,595 (1)% 5% 7 ~80% of sales generated ex - US (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.
Women’s Health Women’s Health Revenues $ mil Q2 - 2022 Q2 - 2021 (mid - year spin) Act VPY Ex FX VPY 2022 YTD 2021 YTD (mid - year spin) Act VPY Ex FX VPY Top Contraception Products Nexplanon ® 195 184 6% 8% 366 368 — % 1% NuvaRing ® 42 53 (21)% (18)% 83 98 (16)% (12)% Cerazette Œ 15 18 (16)% (9)% 32 34 (6)% — % Top Fertility Products Follistim ® 58 65 (11)% (9)% 119 117 2% 4% Ganirelix Acetate Injection 32 31 3% 9% 61 60 3% 7% Other Women's Health products 67 66 2% 5% 125 139 (10)% (7)% Total Women's Health 408 417 (2)% 1% 786 816 (4)% (1)% 8 • Nexplanon grew 8% at constant currency; strong demand trends • Fertility impacted by COVID lockdowns in China and channel mix in the US 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 Q2 - 2022 Q2 - 2021 (mid - year spin) Act VPY Ex FX VPY 2022 YTD 2021 YTD (mid - year spin) Act VPY Ex FX VPY Renflexis ® 59 43 38% 39% 105 81 30% 30% Ontruzant ® 35 22 57% 61% 57 45 28% 33% Brenzys Œ 14 11 28% 34% 28 21 34% 39% Aybintio Œ 9 8 14% 27% 19 16 20% 32% Hadlima Œ 2 2 NM NM 8 4 99% 101% Biosimilars 119 86 39% 42% 217 166 31% 34% 9 • Double digit growth for Renflexis and Ontruzant • US demand for biosimilars continues to grow Totals may not foot due to rounding . Trademarks appearing above in italics are trademarks of, or are used under license by, the Organon group of companies .
Established Brands Established brands Revenues $ mil Q2 - 2022 Q2 - 2021 (mid - year spin) Act VPY Ex FX VPY 2022 YTD 2021 YTD (mid - year spin) Act VPY Ex FX VPY Cardiovascular 412 430 (4)% 3% 822 819 — % 7% Respiratory 254 248 2% 8% 559 484 16% 21% Non - Opioid Pain, Bone & Dermatology 209 218 (4)% 2% 410 398 3% 9% Other 143 149 (17)% (18)% 280 301 (34)% (34)% Total Est. Brands 1,018 1,045 (2)% 4% 2,072 2,002 3% 10% 10 • Growth in most therapy areas • Improved erosion curve; tracking to flat or better growth for full year • VBP delays and competitor supply interruptions aid 1H performance Totals may not foot due to rounding .
New IPR&D treatment ~$100M impact to Q2 Adj. EBITDA $ mil Q2 - 22 Q2 - 21 (mid - year spin) Actual VPY 2022 YTD 2021 YTD (mid - year spin) Actual VPY Revenues 1,585 1,595 (1)% 3,152 3,101 2% Cost of sales 588 583 1% 1,149 1,174 (2)% Gross profit 997 1,012 (1)% 2,003 1,927 4% Non - GAAP Adjusted Gross profit (1) 1,047 1,047 — % 2,089 1,984 5% Selling, general and administrative 423 416 2% 794 798 (1)% Research and development (2) 203 76 167% 299 143 109% Adjusted EBITDA (2, 3) 512 627 (18)% 1,159 1,193 (3)% Diluted Earnings per Share (EPS), continuing operations (2) 0.92 1.70 (46)% 2.28 3.25 (30)% Non - GAAP adjusted diluted EPS, continuing operations (2, 4) 1.25 1.72 (27)% 2.90 3.50 (17)% Acquired IPR&D and milestones 97 — 97 — Per share impact to diluted EPS from acquired IPR&D and milestones (0.30) — (0.30) — 11 (1) See Slide 20 of this presentation for a reconciliation of Gross Profit to Adjusted Gross Profit. (2) Includes acquired IPR&D and milestones (3) See Slides 21 - 22 of this presentation for a reconciliation of EBITDA and Adjusted EBITDA measures. (4) See Slides 23 - 24 of this presentation for a reconciliation of diluted EPS to non - GAAP adjusted diluted EPS Gross margin 62.9% 63.4% 63.5% 62.1% Non - GAAP Adjusted Gross margin (1) 66.1% 65.6% 66.3% 64.0% Adjusted EBITDA margin (2) 32.3% 39.3% 36.8% 38.5%
Balancing commercial and pipeline business development Commercialized/soon to be commercialized assets Building a pipeline • March 2022 - Licensing agreement for Xaciato Œ • July 2022 - Licensing agreement for a novel investigational non - hormonal, on - demand contraceptive candidate with Cirqle Biomedical • February 2022 - Acquisition of commercial rights to Marvelon Œ and Mercilon Œ in certain Asian markets • June 2022 - Licensing agreement to commercialize Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) biosimilar candidates • June 2021 - Acq. of Alydia Health and its JADA® System • July 2021 - Licensing of investigational agent, ebopiprant • December 2021 - Acquisition of Forendo Pharma Approx 1% contribution to revenues in 2022 Investments in R&D spend 12
13 $ mil $100 million voluntary debt repayment in Q2 - Bank covenant (*) net leverage ratio ~3.5x Debt capitalization as of June 30, 2022 June 30, 2021 September 30, 2021 December 31, 2021 March 31, 2022 June 30, 2022 Reported cash and cash equivalents 730 1,008 737 694 545 Cash for IOM - exit inventory (1) (400) (320) (0) (0) (0) Cash available to Organon 330 688 737 694 545 Gross Debt (2) 9,348 9,298 9,134 9094 8,893 Net Debt (2) 9,018 8,610 8,397 8,400 8,348 (1) Organon’s starting cash balance at spin included $400 million from Merck & Co., Inc., Rahway, NJ, USA which was used for the pur chase of inventory upon exit of certain Interim Operating Model arrangements. (2) Debt figures are net of discounts and unamortized fees of $135 million, $130 million, $124 million, $119 million, and $113 mi lli on as of June 30, 2021, September 30, 2021, December 31, 2021, March 31, 2022, and June 30, 2022 respectively. (*) The definition of net debt in the company's credit agreement excludes unamortized fees, but includes capitalized lease oblig ati ons. Additionally, the LTM EBITDA calculation excludes acquired IPR&D and milestone charges
$ mil 14 FX headwinds persist, masking solid volume growth (1) (2) $6,304 $6,100 – $6,300 <(100) ~(50) ~(200) +600 - +700 ~(100) (350) − (400 ) FX ~550 - 650 bps headwind to growth in 2022 (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.. (2) Based on 2021 performance and July month end spot rates for 2022.
FY 2022 guidance recast for IPR&D and FX; no change operationally 15 $M, provided on a Non - GAAP basis, except Revenues Guidance provided May 5, 2022 FX impact IPR&D Guidance provided as of August 4, 2022 Revenues $6,100 - $6,400 from 300 - 475 bps to 550 - 650 bps $6,100 - $6,300 Adjusted gross margin Mid - 60% range Unchanged SG&A (as % of revenues) Mid - 20% range Unchanged R&D (as % of revenues) Mid - upper single - digit Upper single digit Adjusted EBITDA margin 34% - 36% ~($110) 32% - 34% Interest expense ~$400 Unchanged Depreciation $100 - $115 Unchanged Effective non - GAAP tax rate 17.5% - 19.5% Unchanged Fully diluted weighted avg. shares outstanding ~255M Unchanged
Q&A
Appendix
Established Brands sizeable and stable base of revenue $ mil 18
Franchise performance $ mil Q2 - 2022 Q2 - 2021 (mid - year spin) Actual VPY Ex FX VPY 2022 YTD 2021 YTD (mid - year spin) Actual VPY Ex FX VPY Women’s Health 408 417 (2)% 1% 786 816 (4)% (1)% Biosimilars 119 86 39% 42% 217 166 31% 34% Est. Brands 1,018 1,045 (2)% 4% 2,072 2,002 3% 10% Other (1) 40 47 (17)% (18)% 76 117 (34)% (34)% Total Revenues 1,585 1,595 (1)% 5% 3,152 3,101 2% 6% (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. 19
Gross margin reconciliation $ mil Q2 - 2022 Q2 - 2021 (mid - year spin) YTD 2022 YTD 2021 (mid - year spin) Revenues 1,585 1,595 3,152 3,101 Cost of sales 588 583 1,149 1,174 Gross Profit 997 1,012 2,003 1,927 Gross Margin 62.9% 63.4% 63.5% 62.1% Amortization 28 22 56 42 One - time costs (1) 19 10 24 10 Stock - based compensation 3 3 6 5 Non - GAAP Adjusted Gross Profit (2) 1,047 1,047 2,089 1,984 Non - GAAP Adjusted Gross Margin 66.1% 65.6% 66.3% 64.0% 20 (1) One - time costs for the three and six months ended June 30, 2022 primarily include costs to stand up the Company and inventory s tep - up adjustments as well as a $9 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 compensa tion expense allocated to Cost of sales.
Income from continuing operations before income taxes to Adjusted EBITDA $ mil Q2 - 2022 Q2 - 2021 (mid - year spin) Income from continuing operations before income taxes 287 437 Depreciation 22 21 Amortization (1) 28 22 Interest expense 98 62 EBITDA 435 542 Restructuring costs — 1 One - time costs (2) 58 66 Stock - based compensation 19 18 Adjusted EBITDA 512 627 Adjusted EBITDA margin 32.3% 39.3% 21 (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 intang ible asset, and inventory step up adjustments. For the three months ended June 30, 2022, approximately $28 million of the one - time costs are recorded in Selling, general and administrative expenses, $19 million are recorded in Cost of sales, $8 million are recorded in Other (income) expense, and $3 million are recorded in Research and development. For the three months en ded June 30, 2021, approximately $55 million of the one - time costs are recorded in Selling, general and administrative expenses, and approximately $10 million are recorded in Cost of sales.
Income from continuing operations before income taxes to Adjusted EBITDA $ mil 2022 YTD 2021 YTD (mid - year spin) Income from continuing operations before income taxes 729 904 Depreciation 47 39 Amortization (1) 56 42 Interest expense 195 62 EBITDA 1,027 1,047 Restructuring costs — 2 One - time costs (2) 98 115 Stock - based compensation 34 29 Adjusted EBITDA 1,159 1,193 Adjusted EBITDA margin 36.8% 38.5% 22 (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 intangi ble asset, and inventory step - up adjustments. For the six months ended June 30, 2022, approximately $53 million of the one - time costs are recorded in Selling, general and administrative expenses, approxim ately $24 million are recorded in Cost of sales, $14 million are recorded in Other (income) expense, and $7 million are recorded in Research and development. For the six months ended June 30, 2021, approximately $104 mil lion of the GAAP one - time costs are recorded in Selling, general and administrative expenses, and approximately $10 million are recorded in Cost of sales.
Income from continuing operations before income taxes to Adjusted Net Income $ mil (except EPS) Q2 - 2022 Q2 - 2021 (mid - year spin) Income from continuing operations before income taxes 287 437 Amortization (1) 28 22 Restructuring costs — 1 One - time costs (2) 58 66 Stock - based compensation 19 18 Total Adjustments 105 107 Non - GAAP pre - tax income, continuing operations 392 544 Taxes on income as reported in accordance with GAAP 53 6 Tax benefit on adjustments 20 20 Tax benefit (deduction) on GAAP - only discrete items (3) — 81 Non - GAAP adjusted taxes on income 73 107 Non - GAAP adjusted net income, continuing operations 319 437 Non - GAAP adjusted net income, continuing operations per diluted share 1.25 1.72 23 (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 intang ible asset, and inventory step - up adjustments. For the three months ended June 30, 2022, approximately $28 million of the one - time costs are recorded in Selling, general and administrative expenses, $19 million are recorded in Cost of sales, $ 8 million are recorded in Other (income) expense, and $3 million are recorded in Research and development. For the three months ended June 30, 2021, approximately $55 million of the one - time costs are recorded in Selling, general and administr ative expenses, and approximately $10 million are recorded in Cost of sales. (3) For the three months ended June 30, 2021, the company recorded a tax benefit of approximately $70 million related to a portio n of non - US step up in tax basis as a result of its separation from Merck & Co., Inc., Rahway, NJ, USA
Income from continuing operations before income taxes to Adjusted Net Income $ mil (except EPS) 2022 YTD 2021 YTD (mid - year spin) Income from continuing operations before income taxes 729 904 Amortization (1) 56 42 Restructuring costs — 2 One - time costs (2) 98 115 Stock - based compensation 34 29 Total Adjustments 188 188 Non - GAAP pre - tax income, continuing operations 917 1,092 Taxes on income as reported in accordance with GAAP 147 78 Tax benefit on adjustments 34 35 Tax benefit (deduction) on GAAP - only discrete items (3) (3) 91 Non - GAAP adjusted taxes on income 178 204 Non - GAAP adjusted net income, continuing operations 739 888 Non - GAAP adjusted net income, continuing operations per diluted share 2.90 3.50 (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 intangib le asset, and inventory step - up adjustments. For the six months ended June 30, 2022, approximately $53 million of the one - time costs are recorded in Selling, general and administrative expenses, approximately $24 million are recorded in Cost of sales, $14 million are recorded in Other (income) expense, and $7 million are recorded in Research and development. For the six months ended June 30, 2021, approximately $104 million of the GAAP one - time costs are recorded in Selli ng, general and administrative expenses, and approximately $10 million are recorded in Cost of sales. (3) For the three months ended June 30, 2021, the company recorded a tax benefit of approximately $70 million related to a portio n of non - US step up in tax basis as a result of its separation from Merck & Co., Inc., Rahway, NJ, USA 24
Number of products 13 5 49 Women’s Health Biosimilars Established Brands Broad and diverse portfolio 25