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
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).
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. Exhibit No. Description 99.1 Transcript of Earnings Conference Call and Webcast, held May 5, 2022 at 8:30 AM EST 104 The cover page of this Current Report on Form 8-K, formatted in Inline XBRL.
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