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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): 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 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 2.02 Results of Operations and Financial Condition.

 

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.

 

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

 

Kate Vossen

(732) 675-8448

 

(201) 275-2711

 

Edward Barger

(267) 614-4669

 

Organon reports results for the second quarter ended 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 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 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."

 

 1 

 

 

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) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties, and allocated amounts from pre-spin revenue 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.

 

 2 

 

 

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
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) See Tables 4,5 and 6 for reconciliations of GAAP to non-GAAP financial measures

 

(2) Adjusted EBITDA and Adjusted EBITDA margin include $97 million in the second quarter of 2022 related to acquired IPR&D and milestones

 

 3 

 

 

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.

 

 4 

 

 

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  FX impact  IPR&D  Current guidance
Revenues  $6.1B - $6.4B  From 300-475 bps to 550-650 bps     $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

 

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.

 

 5 

 

 

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.

 

 6 

 

 

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.

 

 7 

 

 

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).

 

 8 

 

 

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 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.

 

(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 & 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-GAAP Adjusted 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 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 compensation expense allocated to Cost of sales.

 

 

 

 

TABLE 5

 

Organon & Co. 

Reconciliation of GAAP Income from Continuing Operations 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 connection with the spin-off of Organon, an impairment of a licensed intangible 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 administrative expenses, and approximately $10 million are recorded 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 intangible 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 Selling, general and administrative expenses, and approximately $10 million are recorded in Cost of sales.

 

 

 

 

TABLE 6

 

Organon & Co. 

Reconciliation of GAAP Income from Continuing Operations 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 connection with the spin-off of Organon, an impairment of a licensed intangible 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 administrative expenses, and approximately $10 million are recorded 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 intangible 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 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 company recorded 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 separation from 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