EX-99.1 2 tm2329655d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

 

Media Contacts: Karissa Peer Investor Contacts: Jennifer Halchak
  (614) 314-8094   (201) 275-2711
  Kate Vossen   Alex Arzeno
  (732) 675-8448   (203) 550-3972

 

Organon Reports Results for the Third Quarter Ended September 30, 2023

 

Third quarter 2023 revenue of $1,519 million

Third quarter 2023 diluted earnings per share of $0.23 and non-GAAP Adjusted diluted earnings per share of $0.87

Adjusted EBITDA of $447 million

Board of Directors declares quarterly dividend of $0.28 per share

Full year 2023 financial guidance ranges updated:

Revenue range narrowed and lowered to $6.15 billion to $6.25 billion

Adjusted EBITDA margin range narrowed and lowered to 30.5% to 31.5%

 

Jersey City, N.J., November 2, 2023 – Organon (NYSE: OGN) today announced its results for the third quarter ended September 30, 2023.

 

"Since spin, we have given new life to Established Brands and have expanded our pipeline in both Biosimilars and Women's Health," said Kevin Ali, Organon's CEO. "Year to date, all three of our franchises have delivered growth on a constant currency basis. Over the medium term, we expect to deliver mid-single digit revenue growth with the power of our existing portfolio. As we move into 2024, we will be working to reduce leverage and continue to add products that could enhance that growth profile."

 

Third Quarter 2023 Revenue

 

in $ millions  Q3 2023   Q3 2022   VPY   VPY ex-FX 
Women’s Health  $418   $454    (8)%   (7)%
Biosimilars   142    129    10%   10%
Established Brands   935    915    2%   3%
Other (1)   24    39    (36)%   (38)%
Revenues  $1,519   $1,537    (1)%   (1)%

 

(1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties.

 

1

 

 

For the third quarter of 2023, total revenue was $1,519 million, a decrease of 1% on an as-reported basis as well as excluding impact of foreign currency (ex-FX), compared with the third quarter of 2022.

 

Women’s Health revenue decreased 8% on an as-reported basis, and decreased 7% ex-FX in the third quarter of 2023 compared with the third quarter of 2022 driven primarily by a 23% ex-FX decrease of NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) which continues to be impacted by generic competition. Together, the company's fertility products declined 10% ex-FX in the third quarter as unfavorable discount rates in the United States offset growth in demand. Nexplanon® (etonogestrel implant) decreased 3% ex-FX due unfavorable discount rates and a change in the go-to-market model for the product. These factors were partially offset by revenue from the Jada® system, which more than doubled year over year.

 

Biosimilars revenue increased 10% on an as-reported basis as well as ex-FX in the third quarter of 2023, compared with the third quarter of 2022. Renflexis® (infliximab-abda) grew 15% ex-FX in the third quarter due to continued demand and strong volume growth in United States and Canada. Ontruzant® (trastuzumab-dttb) grew 34% ex-FX in the third quarter compared to the prior year period driven by the phasing of a tender in Brazil.

 

Established Brands revenue increased 2% as-reported and increased 3% ex-FX in the third quarter of 2023, despite the impact of Volume Based Procurement (VBP) initiatives in China. Growth in the quarter was driven by Atozet™ (ezetimibe and atorvastatin calcium), particularly in France, strong demand for Nasonex® (mometasone) and favorable pricing for Dulera® (formoterol/fumarate dihydrate) in the United States. Year to date, the Established Brands franchise grew 1% ex-FX. The company expects the Established Brands franchise to achieve flat to slightly better revenue growth on a constant currency basis for the full year 2023.

 

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Third Quarter 2023 Profitability

 

in $ millions, except per share amounts  Q3 2023   Q3 2022   VPY 
Revenues  $1,519   $1,537    (1)%
Cost of sales   612    551    11%
Gross profit   907    986    (8)%
Non-GAAP Adjusted gross profit (1)   951    1,032    (8)%
Adjusted EBITDA (1,2)    447    546    (18)%
Net income   58    227    (74)%
Non-GAAP Adjusted net income (1)   223    337    (34)%
Diluted Earnings per Share (EPS)   0.23    0.89    (74)%
Non-GAAP Adjusted diluted EPS (1)   0.87    1.32    (34)%
Acquired in-process research & development (IPR&D) and milestones       10    NM 
Per share impact to diluted EPS from acquired IPR&D and milestones       (0.04)   NM 

 

   Q3 2023   Q3 2022 
Gross margin   59.7%   64.2%
Non-GAAP Adjusted gross margin (1)   62.6%   67.1%
Adjusted EBITDA margin (1, 2)   29.4%   35.5%

 

(1)See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures

 

(2)Adjusted EBITDA and Adjusted EBITDA margin include $10 million in the third quarter of 2022 related to acquired IPR&D and milestones, no such expense was incurred in the third quarter of 2023

 

Gross margin was 59.7% as-reported and 62.6% on an adjusted basis in the third quarter of 2023 compared with 64.2% as-reported and 67.1% on an adjusted basis in the third quarter of 2022. The year-over-year decline in gross margin is primarily due to foreign exchange translation and inflationary manufacturing and distribution costs. Product mix and pricing erosion were also factors, but to a lesser extent.

 

EBITDA margin was 29.4% in the third quarter of 2023 compared with 35.5% in the third quarter of 2022 primarily due to lower Adjusted gross profit and to a lesser extent an increase in non-GAAP SG&A expense and loss on foreign exchange translation.

 

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Net income for the third quarter of 2023 was $58 million, or $0.23 per diluted share, compared with $227 million, or $0.89 per diluted share, in the third quarter of 2022. Non-GAAP Adjusted net income was $223 million, or $0.87 per diluted share, compared with $337 million, or $1.32 per diluted share, in 2022. The year over year decrease in net income was a result of a lower Adjusted EBITDA, as well as higher interest expense.

 

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 December 14, 2023, to stockholders of record at the close of business on November 13, 2023.

 

As of September 30, 2023, cash and cash equivalents were $414 million, and debt was $8.7 billion.

 

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 2023 guidance ranges previously provided on August 8, 2023. The range for full year 2023 revenue is narrowed and lowered to $6.15 billion to $6.25 billion, which primarily reflects current foreign currency exchange rates, changes to the go-to-market model for Nexplanon, a slower uptake of Hadlima™ (adalimumab-bwwd) and macroeconomic factors in China.

 

The range for full year Adjusted EBITDA margin is now 30.5% to 31.5% to reflect a lower gross margin stemming from the impacts of foreign exchange on revenue, unfavorable product mix, and the timing of manufacturing costs. Organon's financial guidance does not assume an estimate for future IPR&D and milestone payments for business development transactions not yet executed.

 

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Full year 2023 financial guidance is presented below on a non-GAAP basis.

 

   Previous guidance as of
August 8, 2023
  Current guidance
Revenues  $6.250B-$6.450B  $6.150B-$6.250B
Adjusted gross margin  Low-mid 60% range  Low 60% range
SG&A (as % of revenue)  Mid 20% range  Unchanged
R&D (as % of revenue)  Upper single-digit  Unchanged
Adjusted EBITDA margin  31.5%-33.0%  30.5%-31.5%
Interest  ~$525 million  Unchanged
Depreciation  ~$120 million  Unchanged
Effective non-GAAP tax rate  17.5%-19.5%  Unchanged
Fully diluted weighted average shares outstanding  ~257 million  Unchanged

 

Webcast Information

 

Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its third quarter 2023 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/events-and-presentations. 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 by clicking on this link:

 

https://conferencingportals.com/event/VfCOQYEG

 

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 offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. 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 10,000 employees with headquarters located in Jersey City, New Jersey.

 

For more information, visit http://www.organon.com and connect with us on LinkedInInstagram, X (formerly known as Twitter) and Facebook.

 

Cautionary Note Regarding Non-GAAP Financial Measures

 

This press release 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 U.S. generally accepted accounting principles (“GAAP”). Specifically, the company makes use of the non-GAAP financial measures Adjusted EBITDA, Adjusted gross margin, Adjusted gross profit, 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. This press release also provides certain measures that exclude the impact of foreign exchange. We calculate foreign exchange by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. 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 Table 4 and Table 5 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 2023 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, the ultimate outcome of legal proceedings, unusual gains and losses, the occurrence of matters creating GAAP tax impacts 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.

 

Cautionary Note Regarding Forward-Looking Statements

 

Except for historical information, 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, including full-year 2023 guidance estimates and predictions regarding other financial information and metrics, franchise and product performance and strategy expectations for the remainder of 2023 and for future periods, expectations regarding the impact of VBP and developments in China. Forward-looking statements may be identified by words such as "foresees" “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.

 

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Risks and uncertainties include, but are not limited to, an inability to fully execute on our product development and commercialization plans within the United States or internationally; an inability to adapt to the industry-wide trend toward highly discounted channels; changes in tax laws or other tax guidance which could adversely affect our cash tax liability, effective tax rates, and results of operations and lead to greater audit scrutiny; an inability to execute on our business development strategy or realize the benefits of our planned acquisitions; efficacy, safety, or other quality concerns with respect to marketed products, including market actions such as recalls, withdrawals, or declining sales; political and social pressures, or regulatory developments, that adversely impact demand for, availability of, or patient access to contraception or fertility products; general economic factors, including recessionary pressures, 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.

 

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, 2022 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
September 30,
   Nine Months Ended
September 30,
 
   2023   2022   2023   2022 
Revenues  $1,519   $1,537   $4,665   $4,689 
Costs, Expenses and Other                    
Cost of sales   612    551    1,832    1,700 
Selling, general and administrative   538    440    1,424    1,234 
Research and development   137    127    394    329 
Acquired in-process research and development and milestones       10    8    107 
Restructuring costs       11    4    11 
Interest expense   134    108    398    303 
Exchange losses (gains)   14    4    25    (21)
Other expense, net   4    4    11    15 
    1,439    1,255    4,096    3,678 
Income Before Income Taxes   80    282    569    1,011 
Taxes on income   22    55    92    202 
Net Income   58    227    477    809 
                     
Earnings per Share:                    
Basic  $0.23   $0.89   $1.87   $3.19 
Diluted  $0.23   $0.89   $1.86   $3.17 
                     
Weighted Average Shares Outstanding:                    
Basic   255,588    254,348    255,112    253,986 
Diluted   256,349    255,067    256,162    255,094 

 

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TABLE 2

 

Organon & Co.

Sales by top products

(Unaudited, $ in millions)

 

   Three Months Ended September 30,   Nine Months Ended September 30, 
   2023   2022   2023   2022 
   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  $146   $74   $220   $151   $78   $229   $418   $181   $599   $401   $194   $595 
Follistim AQ   22    32    54    27    33    60    74    105    179    79    100    179 
NuvaRing   18    20    37    27    23    50    50    67    117    65    68    133 
Ganirelix Acetate Injection   4    21    25    6    30    36    15    74    88    20    77    97 
Marvelon/Mercilon       30    30        31    31        97    97        85    85 
Jada   12        13    5        5    30        31    12        12 
Other Women's Health (1)   16    22    39    19    23    42    52    74    126    68    70    138 
Biosimilars                                                            
Renflexis   57    12    69    54    7    60    172    29    201    145    20    166 
Ontruzant   11    28    40    15    14    29    36    57    93    35    52    87 
Brenzys       13    13        24    24        45    45        52    52 
Aybintio       12    12        10    10        34    34        29    29 
Hadlima   2    6    8        6    6    2    18    20        14    14 
Established Brands                                                            
Cardiovascular                                                            
Zetia   2    65    66    2    85    87    5    234    239    7    280    287 
Vytorin   2    31    33    1    30    31    5    95    100    6    98    104 
Atozet       126    126        109    109        397    397        350    350 
Rosuzet       17    17        17    17        52    52        55    55 
Cozaar/Hyzaar   3    65    68    2    68    70    8    217    225    11    244    256 
Other Cardiovascular (1)   1    42    44    1    34    35    2    124    126    3    117    120 
Respiratory                                                            
Singulair   3    88    91    3    92    94    8    282    290    8    308    316 
Nasonex       54    55        49    49        187    188    9    173    182 
Dulera   40    9    49    31    9    40    116    28    144    98    30    127 
Clarinex   2    26    28        25    26    4    103    107    3    96    99 
Other Respiratory (1)   17    9    25    11    10    21    42    20    61    34    32    66 
Non-Opioid Pain, Bone and                                                            
Arcoxia       64    64        64    64        207    207        185    185 
Fosamax   1    40    41    1    35    36    2    121    123    2    115    117 
Diprospan       31    31        28    28        58    58        91    91 
Other Non-Opioid Pain, Bone and Dermatology (1)   4    70    74    2    63    65    11    196    207    10    200    210 
Other                                                            
Proscar       25    25        26    27    1    76    77    1    76    77 
Propecia   2    21    22    2    28    30    5    86    92    5    90    95 
Other (1)   5    72    76    6    81    87    10    231    240    21    230    251 
Other (2)       24    24        39    39    (1)   103    102        115    116 
Revenues  $370   $1,149   $1,519   $366   $1,171   $1,537   $1,067   $3,598   $4,665   $1,043   $3,646   $4,689 

 

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. Revenues from Marvelon and Mercilon and Jada were previously reported as part of Other Women's Health. 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.

 

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TABLE 3

 

Organon & Co.

Sales by geographic area

(Unaudited, $ in millions)

 

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2023   2022   2023   2022 
Europe and Canada  $392   $363   $1,259   $1,243 
United States   370    366    1,067    1,043 
Asia Pacific and Japan   284    283    869    888 
China   202    241    661    721 
Latin America, Middle East, Russia, and Africa   239    236    687    665 
Other (1)   32    48    122    129 
Revenues  $1,519   $1,537   $4,665   $4,689 

 

(1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties.

 

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TABLE 4

 

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

(Unaudited, $ in millions except per share amounts)

 

   Three Months Ended September 30, 2023 
   GAAP   Spin related
Costs(1)
   Restructuring   Stock-based
Compensation
   Amortization   Other(1)   Non-GAAP
Adjusted
 
Revenues  $1,519                            $1,519 
Cost of sales   612    (10)       (5)   (29)       568 
Gross profit   907                             951 
Gross margin   59.7%                            62.6%
                                    
Selling, general and administrative   538    (41)       (18)       (87)   392 
Research and development   137    (4)       (4)           129 
Acquired in-process research and development and milestones                            
Restructuring costs                            
Interest expense   134                        134 
Exchange losses   14                        14 
Other expense (income), net   4    (3)                   1 
    1,439                             1,238 
Income before income taxes   80                             281 
Taxes on income   22    16        4    5    11    58 
Net income  $58                            $223 
                                    
Earnings per share - Diluted  $0.23                            $0.87 

 

(1) Represents one-time costs. Spin-related includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US and Other primarily includes inventory step-up amortization, impairment charges and legal reserves.

 

   Three Months Ended September 30, 2022 
   GAAP   Spin related
Costs(1)
   Restructuring   Stock-based
Compensation
   Amortization   Other(1)   Non-GAAP
Adjusted
 
Revenues  $1,537                            $1,537 
Cost of sales   551    (8)       (3)   (32)   (3)   505 
Gross profit   986                             1,032 
Gross margin   64.2%                            67.1%
                                    
Selling, general and administrative   440    (33)       (12)       (17)   378 
Research and development   127    (2)       (3)       (1)   121 
Acquired in-process research and development and   10                        10 
Restructuring costs   11        (11)                
Interest expense   108                        108 
Exchange gains   4                        4 
Other expense (income), net   4    (6)                   (2)
    1,255                             1,124 
Income before income taxes   282                             413 
Taxes on income   55    10    2    2    6    1    76 
Net income  $227                            $337 
                                    
Earnings per share - Diluted  $0.89                            $1.32 

 

(1) Represents one-time costs. Spin-related includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US and Other primarily includes inventory step-up amortization, impairment charges and legal reserves.

 

12

 

 

TABLE 4 (Continued)

 

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

(Unaudited, $ in millions except per share amounts)

 

   Nine Months Ended September 30, 2023 
   GAAP   Spin related
Costs(1)
   Restructuring   Stock-based
Compensation
   Amortization   Other(1)   Non-GAAP
Adjusted
 
Revenues  $4,665                            $4,665 
Cost of sales   1,832    (30)       (13)   (88)   (2)   1,699 
Gross profit   2,833                             2,966 
Gross margin   60.7%                            63.6%
                                    
Selling, general and administrative   1,424    (131)       (50)       (88)   1,155 
Research and development   394    (10)       (11)           373 
Acquired in-process research and development and milestones   8                        8 
Restructuring costs   4        (4)                
Interest expense   398                        398 
Exchange losses   25                        25 
Other expense (income), net   11    (13)                   (2)
    4,096                             3,656 
Income before income taxes   569                             1,009 
Taxes on income   92    42    1    12    16    11    174 
Net income  $477                            $835 
                                    
Earnings per share - Diluted  $1.86                            $3.26 

 

(1) Represents one-time costs. Spin-related includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US and Other primarily includes inventory step-up amortization, impairment charges and legal reserves.

 

   Nine Months Ended September 30, 2022 
   GAAP   Spin related
Costs(1)
   Restructuring   Stock-based
Compensation
   Amortization   Other(1)   Non-GAAP
Adjusted
 
Revenues  $4,689                            $4,689 
Cost of sales   1,700    (18)       (9)   (88)   (17)   1,568 
Gross profit   2,989                             3,121 
Gross margin   63.7%                            66.6%
                                    
Selling, general and administrative   1,234    (86)       (35)       (17)   1,096 
Research and development   329    (8)       (8)       (2)   311 
Acquired in-process research and development and   107                        107 
Restructuring costs   11        (11)                
Interest expense   303                        303 
Exchange gains   (21)                       (21)
Other expense (income), net   15    (20)                   (5)
    3,678                             3,359 
Income before income taxes   1,011                             1,330 
Taxes on income   202    24    2    7    15    4    254 
Net income  $809                            $1,076 
                                    
Earnings per share - Diluted  $3.17                            $4.22 

 

(1) Represents one-time costs. Spin-related includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US and Other primarily includes inventory step-up amortization, impairment charges and legal reserves.

 

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TABLE 5

 

Organon & Co.

Reconciliation of GAAP Income Before Income Taxes to Adjusted EBITDA

(Unaudited, $ in millions)

 

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2023   2022   2023   2022 
Income before income taxes  $80   $282   $569   $1,011 
Depreciation   32    25    88    72 
Amortization   29    32    88    88 
Interest expense   134    108    398    303 
EBITDA  $275   $447   $1,143   $1,474 
Restructuring costs       11    4    11 
One-time costs (1)   145    70    274    168 
Stock-based compensation   27    18    74    52 
Adjusted EBITDA  $447   $546   $1,495   $1,705 
Adjusted EBITDA margin   29.4%   35.5%   32.0%   36.4%

 

(1) One-time costs primarily include costs incurred in connection with the spin-off of Organon, inventory step up adjustments, impairment charges and legal reserves.

 

15