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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of Report
(Date of earliest event reported): October 30, 2026
Organon
& Co.
(Exact name of registrant
as specified in its charter)
| Delaware |
|
001-40235 |
|
46-4838035 |
| (State or other jurisdiction of |
|
(Commission File Number) |
|
(I.R.S. Employer Identification No.) |
| incorporation) |
|
| |
| |
|
|
|
|
30
Hudson Street, Floor
33,
Jersey City,
NJ |
|
|
|
07302 |
| (Address and principal executive offices) |
|
|
|
(Zip Code) |
| Registrant’s telephone number, including area code: (551)
430-6900 |
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any
of the following provisions:
| ¨ | Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of
each class |
|
Trading
Symbol(s) |
|
Name of
each exchange on which registered |
| Common
Stock, par value $0.01 per share |
|
OGN |
|
NYSE |
Indicate by check mark whether the registrant is
an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 7.01. |
Regulation FD Disclosure. |
On
October 30, 2026, Organon & Co. (the “Company”) released its financial results for the quarter ended September
30, 2026 with the filing of the Company’s Quarterly Report on Form 10-Q (the “Form 10-Q”) with the Securities
and Exchange Commission (the “SEC”). As previously disclosed, in light of the Company’s pending merger with Sun
Pharmaceutical Industries Limited, the Company has suspended its customary practice of issuing a quarterly earnings press release and
hosting an earnings conference call.
As
part of the information provided in historic Company earnings press releases, the Company would furnish, together with its U.S. generally
accepted accounting principles (“GAAP”) financial information for the reported quarterly period, certain supplemental
non-GAAP financial metrics for the same reported period. These supplemental measures have been made available by the Company based on
the belief that this information assists in understanding the Company’s financial performance, but not as a substitute for the Company’s
financial results under GAAP.
To
continue this practice, the Company is furnishing certain supplemental non-GAAP metrics for the quarter ended September 30, 2026 that
are included in Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference. The non-GAAP financial metrics for
the quarter ended September 30, 2026 that are furnished in this Form 8-K should be read together with the Company’s GAAP financial
statements and other disclosures that are contained in Exhibit 99.1 and that are more fully disclosed in the Form 10-Q filed with the
SEC on October 30, 2026.
The
information contained 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 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 Current Report on Form
8-K, including Exhibit 99.1, 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 |
|
Supplemental Financial Information of Organon & Co. for the quarterly period ended September 30, 2026. |
| |
|
|
| 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: October
30, 2026
Exhibit 99.1

Supplemental Financial Information
This exhibit provides certain supplemental non-GAAP
financial measures for the quarter ended September 30, 2026. As disclosed in the accompanying Current Report on Form 8-K, Organon
& Co. (the “Company”) is furnishing this information in lieu of including such supplemental measures in a quarterly earnings
release. As referenced below, the Company believes that these supplemental measures assist in understanding its financial performance,
but that such measures should not be considered as a substitute for the Company’s financial results prepared in accordance with
U.S. generally accepted accounting principles (“GAAP”). Accordingly, these supplemental measures are intended by the Company
to accompany, and should be considered together with, the Company’s GAAP financial results and disclosures referenced in this Exhibit,
as well as contained in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2026 that has been
filed with the Securities and Exchange Commission on October 30, 2026.
Cautionary Note Regarding Non-GAAP Financial
Measures
As discussed above, this exhibit contains “non-GAAP
financial measures,” which are financial measures that either exclude or include amounts that are correspondingly not excluded or
included in the most directly comparable measures calculated and presented in accordance with GAAP. Specifically, the Company makes use
of the non-GAAP financial measures Adjusted EBITDA, Adjusted EBITDA margin, Adjusted Gross Margin, Adjusted Gross Profit, Adjusted net
income, Adjusted diluted EPS, Adjusted Selling, general and administrative expenses, and Adjusted Research and development expenses, 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, which exclude certain items, help to enhance its ability to meaningfully communicate
its underlying business performance, financial condition and results of operations. The Company’s management uses the non-GAAP financial
measures described above to evaluate the Company’s performance and to guide operational and financial decision making. 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. Please refer to the tables below for reconciliations
of the non-GAAP financial measures presented herein to the most directly comparable GAAP measures.
| Organon & Co. |
| Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics |
| (Unaudited, $ in millions) |
| |
| | |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| GAAP Gross Profit | |
$ | 869 | | |
$ | 857 | | |
$ | 2,499 | | |
$ | 2,572 | |
| Adjusted for: | |
| | | |
| | | |
| | | |
| | |
| Manufacturing network costs (1) | |
| 17 | | |
| 39 | | |
| 56 | | |
| 101 | |
| Stock-based compensation | |
| 4 | | |
| 4 | | |
| 11 | | |
| 12 | |
| Amortization | |
| 48 | | |
| 52 | | |
| 141 | | |
| 155 | |
| Acquisition-related costs (2) | |
| — | | |
| 12 | | |
| 7 | | |
| 31 | |
| Other | |
| — | | |
| 2 | | |
| — | | |
| 12 | |
| Adjusted Non-GAAP Gross Profit | |
$ | 938 | | |
$ | 966 | | |
$ | 2,714 | | |
$ | 2,883 | |
| |
|
|
|
|
|
|
|
|
(1) Manufacturing network related costs include costs from exiting
manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to the line item Manufacturing
network related in the Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA.
(2) Acquisition-related costs reflect the amortization pertaining
to the fair value inventory purchase accounting adjustment for the Dermavant Sciences Ltd. (“Dermavant”) transaction. For
additional details refer to the Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA. |
| | |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| GAAP Gross Margin | |
| 55.2 | % | |
| 53.5 | % | |
| 54.4 | % | |
| 54.6 | % |
| Total impact of Non-GAAP adjustments | |
| 4.4 | % | |
| 6.8 | % | |
| 4.7 | % | |
| 6.6 | % |
| Adjusted Non-GAAP Gross Margin | |
| 59.6 | % | |
| 60.3 | % | |
| 59.1 | % | |
| 61.2 | % |
| | |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| GAAP Selling, general and administrative expenses | |
$ | 421 | | |
$ | 415 | | |
$ | 1,279 | | |
$ | 1,288 | |
| Adjusted for: | |
| | | |
| | | |
| | | |
| | |
| Stock-based compensation | |
| (14 | ) | |
| (16 | ) | |
| (43 | ) | |
| (46 | ) |
| Restructuring related charges | |
| — | | |
| — | | |
| — | | |
| (10 | ) |
| Other (1) | |
| (21 | ) | |
| (5 | ) | |
| (48 | ) | |
| (34 | ) |
| Adjusted Non-GAAP Selling, general and administrative expenses | |
$ | 386 | | |
$ | 394 | | |
$ | 1,188 | | |
$ | 1,198 | |
| | |
| | | |
| | | |
| | | |
| | |
| (1) For additional details refer to the Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA. | | |
| | |
| Organon & Co. |
| Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Continued) |
| (Unaudited, $ in millions except per share amounts) |
| |
| | |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| GAAP Research and development expenses | |
$ | 83 | | |
$ | 84 | | |
$ | 266 | | |
$ | 275 | |
| Adjusted for: | |
| | | |
| | | |
| | | |
| | |
| Manufacturing network costs (1) | |
| (3 | ) | |
| (2 | ) | |
| (10 | ) | |
| (8 | ) |
| Stock-based compensation | |
| (3 | ) | |
| (4 | ) | |
| (11 | ) | |
| (12 | ) |
| Other (2) | |
| (1 | ) | |
| (2 | ) | |
| (2 | ) | |
| (3 | ) |
| Adjusted Non-GAAP Research and development expenses | |
$ | 76 | | |
$ | 76 | | |
$ | 243 | | |
$ | 252 | |
| |
|
|
|
|
|
|
|
| (1) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to the Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA. |
| (2) For additional details refer to the Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA. |
| | |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| GAAP Reported Net Income | |
$ | 164 | | |
$ | 160 | | |
$ | 418 | | |
$ | 392 | |
| Adjusted for: | |
| | | |
| | | |
| | | |
| | |
| Cost of sales adjustments | |
| 69 | | |
| 109 | | |
| 215 | | |
| 311 | |
| Selling, general and administrative adjustments | |
| 35 | | |
| 21 | | |
| 91 | | |
| 90 | |
| Research and development adjustments | |
| 7 | | |
| 8 | | |
| 23 | | |
| 23 | |
| Jada divestiture | |
| — | | |
| — | | |
| (81 | ) | |
| — | |
| Restructuring | |
| — | | |
| — | | |
| 31 | | |
| 88 | |
| Change in fair value of contingent consideration | |
| (10 | ) | |
| (32 | ) | |
| (6 | ) | |
| (9 | ) |
| Other expense (gain), net (1) | |
| 8 | | |
| 4 | | |
| 27 | | |
| (37 | ) |
| Tax impact on adjustments above(2) | |
| (17 | ) | |
| (7 | ) | |
| (44 | ) | |
| (69 | ) |
| Non-GAAP Adjusted Net Income | |
$ | 256 | | |
$ | 263 | | |
$ | 674 | | |
$ | 789 | |
| (1) For additional details refer to the Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA. |
| (2) For the three months ended September 30, 2026 and 2025, the GAAP income tax rates were 35.7% and 34.0%, respectively, and the non-GAAP income tax rates were 29.9% and 25.3%, respectively. For the nine months ended September 30, 2026 and 2025, the GAAP income tax rates were 35.8% and 31.6%, respectively, and the non-GAAP income tax rates were 29.2% and 24.0%, respectively. These adjustments represent the estimated tax impacts on the reconciling items by applying the statutory rate and applicable law of the originating territory of the non-GAAP adjustments. |
| |
|
|
|
|
|
|
|
| | |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| GAAP Diluted Earnings per Share | |
$ | 0.60 | | |
$ | 0.61 | | |
$ | 1.56 | | |
$ | 1.50 | |
| Total impact of Non-GAAP adjustments | |
| 0.34 | | |
| 0.40 | | |
| 0.95 | | |
| 1.53 | |
| Non-GAAP Adjusted Diluted Earnings per Share | |
$ | 0.94 | | |
$ | 1.01 | | |
$ | 2.51 | | |
$ | 3.03 | |
Organon & Co.
Reconciliation of GAAP Net Income to Non-GAAP
Adjusted EBITDA
(Unaudited, $ in millions)
| | |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| GAAP Reported Net Income | |
$ | 164 | | |
$ | 160 | | |
$ | 418 | | |
$ | 392 | |
| Depreciation (1) | |
| 32 | | |
| 37 | | |
| 102 | | |
| 102 | |
| Amortization | |
| 48 | | |
| 52 | | |
| 141 | | |
| 155 | |
| Interest expense | |
| 106 | | |
| 128 | | |
| 325 | | |
| 383 | |
| Income tax expense | |
| 91 | | |
| 83 | | |
| 233 | | |
| 181 | |
| EBITDA (Non-GAAP) | |
$ | 441 | | |
$ | 460 | | |
$ | 1,219 | | |
$ | 1,213 | |
| Restructuring and related charges | |
| — | | |
| — | | |
| 31 | | |
| 98 | |
| Manufacturing network related (2) | |
| 23 | | |
| 46 | | |
| 76 | | |
| 118 | |
| Acquisition-related costs (3) | |
| — | | |
| 12 | | |
| 7 | | |
| 31 | |
| Change in contingent consideration | |
| (10 | ) | |
| (32 | ) | |
| (6 | ) | |
| (9 | ) |
| Jada divestiture | |
| — | | |
| — | | |
| (81 | ) | |
| — | |
| Other costs (4) | |
| 27 | | |
| 8 | | |
| 67 | | |
| 3 | |
| Stock-based compensation | |
| 21 | | |
| 24 | | |
| 65 | | |
| 70 | |
| Adjusted EBITDA (Non-GAAP) | |
$ | 502 | | |
$ | 518 | | |
$ | 1,378 | | |
$ | 1,524 | |
| Adjusted EBITDA margin (Non-GAAP) | |
| 31.9 | % | |
| 32.3 | % | |
| 30.0 | % | |
| 32.4 | % |
| (1) Excludes accelerated depreciation included in one-time costs. |
| (2) Manufacturing network related costs, which include costs of exiting of temporary manufacturing and supply agreements with Merck & Co., Inc., Rahway, NJ, US, reflect accelerated depreciation, exit premiums, technology transfer costs, stability and qualification batch costs, and third-party contractor costs. |
| (3) Acquisition related costs for the three months ended September 30, 2025 and the nine months ended September 30, 2026 and 2025, respectively, reflect the amortization pertaining to the fair value inventory purchase accounting adjustment for the Dermavant transaction. |
| (4) Other costs for the three months ended September 30, 2026 include $19 million related to the pending transaction with Sun Pharmaceutical Industries Limited. Other costs for the nine months ended September 30, 2026 include $30 million related to the pending transaction with Sun Pharmaceutical Industries Limited and $17 million related to an unfavorable resolution of a working capital matter related to the Dermavant acquisition. |
| |
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|
| As the costs described in (1) through (4) above are directly related to the separation of Organon and acquisition related activities and therefore arise from a one-time event outside of the ordinary course of the company’s operations, the adjustment of these items provides meaningful, supplemental, information that the company believes will enhance an investor's understanding of the company's ongoing operating performance. |