| Item 7.01 |
Regulation FD Disclosure. |
On May 5, 2022, Organon & Co.
(the “Company”) held a conference call and webcast to discuss its financial results for the quarter ended March 31, 2022.
A copy of the transcript is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
The information in this Item 7.01,
including Exhibit 99.1 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.
Non-GAAP Financial Measures
The transcript 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. A reconciliation of these Non-GAAP financial
measures to the most directly comparable GAAP measures is provided in the conference call materials referred to on the webcast and conference
call, a copy of which has been furnished as Exhibit 99.2 to the Company’s Form 8-K previously filed with the Securities and Exchange
Commission on May 5, 2022. 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 Statements
Except for historical information
therein, the transcript 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; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk; difficulties developing and sustaining relationships with commercial
counterparties; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the
exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation
to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors
that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s
filings with the Securities and Exchange Commission ("SEC"), including the company’s Annual Report on Form 10-K for the
year ended December 31, 2021 and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov).