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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): May 1, 2025

 

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 2.02 Results of Operations and Financial Condition.

 

On May 1, 2025, Organon & Co. (the “Company”) issued a press release (the “Earnings Release”) regarding its results for the quarter ended March 31, 2025. A copy of 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 May 1, 2025, the Company made available the Company Information Presentation relating to its financial results for the quarter ended March 31, 2025. 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 8.01 Other Events.

 

On May 1, 2025, the Company’s Board of Directors declared a quarterly dividend of $0.02 for each issued and outstanding share of the Company’s common stock. This is a revision from the Company’s prior quarterly dividend rate of $0.28 per share. The dividend is payable on June 12, 2025, to stockholders of record at the close of business on May 12, 2025.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
99.1   Press Release, dated May 1, 2025, 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: May 1, 2025

 

 

 

Exhibit 99.1

 

 

 

Media Contacts: Karissa Peer   Investor Contacts: Jennifer Halchak
  (614) 314-8094
Kate Vossen
(732) 675-8448
    (201) 275-2711
Renee McKnight
(551) 204-6129  

 

Organon Reports Results for the First Quarter Ended March 31, 2025

 

Company affirms full year 2025 financial guidance, resets dividend payout to strengthen capital structure

 

·Guidance ranges for full year 2025 revenue and Adjusted EBITDA margin are affirmed; company expects to generate over $900 million of free cash flow before one-time costs in 2025

 

·Vtama on track to achieve $150 million revenue target for full year 2025; double-digit growth in Nexplanon in the first quarter

 

·Company resets capital allocation priorities to accelerate progress towards deleveraging; new annual regular dividend rate of $0.08 per share

 

·First quarter 2025 revenue of $1.513 billion, down 7% as-reported and down 4% at constant currency, consistent with company’s expectations

 

·First quarter 2025 diluted earnings per share of $0.33 and non-GAAP Adjusted diluted earnings per share of $1.02

 

·First quarter 2025 net income of $87 million and Adjusted EBITDA (non-GAAP) of $484 million, representing an Adjusted EBITDA margin of 32.0%

 

 1 

 

 

Jersey City, N.J., May 1, 2025 – Organon (NYSE: OGN) today announced its results for the first quarter ended March 31, 2025.

 

“We have reset our capital allocation priorities to accelerate progress towards deleveraging, enabling a path to achieve a net leverage ratio of below 4.0x by year-end. Over the last year, we have established a leaner, more fit-for-purpose cost structure while increasing revenue contribution from our core growth drivers. By deleveraging more rapidly, we will continue to strengthen the future prospects of the company. Over time, this will position us to execute more of the compelling business development we’ve done to date, bringing in additional growth drivers to our portfolio, while maintaining lower leverage,” said Kevin Ali, Organon’s CEO. “With key growth drivers, Nexplanon and Vtama, on track to achieve their revenue objectives for the year, we are affirming our full year revenue and Adjusted EBITDA margin guidance, as well as our target of generating over $900 million of free cash flow before one-time costs.”

 

First Quarter 2025 Revenue

 

in $ millions  Q1 2025   Q1 2024   VPY   VPY ex-FX 
Women’s Health  $463   $422    10%   12%
Biosimilars   141    170    (17)%   (15)%
Established Brands   887    1,001    (11)%   (8)%
Other (1)   22    29    (23)%   (19)%
Revenue  $1,513   $1,622    (7)%   (4)%

 

Totals may not foot due to rounding and percentages are computed using unrounded amounts.

 

(1) Other includes manufacturing sales to third parties.

 

For the first quarter of 2025, total revenue was $1.513 billion, down 7% on an as-reported basis and down 4% year-over-year excluding the impact of foreign currency (ex-FX).

 

Women’s Health revenue increased 10% as-reported and 12% ex-FX in the first quarter of 2025, compared with the first quarter of 2024. Nexplanon® (etonogestrel implant) growth of 14% ex-FX , as well as a favorable year-over-year comparison in Follistim AQ® (follitropin beta injection) related to the exit of a spin-related interim operating model agreement in the United States, together more than offset a 41% ex-FX decline in NuvaRing® (etonogestrel / ethinyl estradiol vaginal ring) attributable to ongoing generic competition.

 

 2 

 

 

Biosimilars revenue declined 17% as-reported and 15% ex-FX in the first quarter of 2025, compared with the first quarter of 2024, primarily due to the return to normalized levels of the contracted volume of Ontruzant® (trastuzumab-dttb) in Brazil, a 17% ex-FX decline in Renflexis® (infliximab-abda) attributable to competitive pricing pressure in the U.S. associated with the maturity of the product, and the timing of international tenders for Brenzys™ (etanercept). Performance was partially offset by sales of Hadlima® (adalimumab-bwwd) that have continued to ramp up since its July 2023 launch in the U.S.

 

Established Brands revenue declined 11% as-reported and 8% ex-FX in the first quarter of 2025. Revenue contribution of Emgality®(1) (galcanezumab-gnlm) and Vtama®(2) (tapinarof), partially offset the impact of the loss of exclusivity (“LOE”) of Atozet™ (ezetimibe and atorvastatin) in key markets in Europe and lower sales of Singulair, particularly in China and Japan.

 

(1) Organon acquired certain European licensing and distribution rights to Emgality and Rayvow from Eli Lilly beginning in early 2024. Emgality and Rayvow are registered trademarks of Eli Lilly in the European Union and other countries (used under license).

 

(2) Vtama was acquired as part of Organon's acquisition of Dermavant Sciences Ltd. (“Dermavant”) which closed on October 28, 2024.

 

 3 

 

 

First Quarter 2025 Profitability

 

in $ millions, except per share amounts  Q1 2025   Q1 2024   VPY 
Revenues  $1,513   $1,622    (7)%
Cost of sales   672    665    1%
Gross profit   841    957    (12)%
Non-GAAP Adjusted gross profit (1)   934    1,007    (7)%
Net income   87    201    (57)%
Non-GAAP Adjusted net income (1)   265    315    (16)%
Diluted Earnings per Share (EPS)   0.33    0.78    (58)%
Non-GAAP Adjusted diluted EPS (1)   1.02    1.22    (16)%
Acquired in-process research & development (IPR&D) and milestones   6    15    —% 
Adjusted EBITDA (Non-GAAP) (1, 2)    484    538    (10)%
                
   Q1 2025   Q1 2024     
Gross margin   55.6%   59.0%     
Non-GAAP Adjusted gross margin (1)   61.7%   62.1%     
Adjusted EBITDA margin (Non-GAAP) (1, 2)   32.0%   33.2%     

 

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

 

(2)Adjusted EBITDA and Adjusted EBITDA margin for 2025 and 2024 include $6 million and $15 million, respectively, related to acquired IPR&D and milestones.

 

Gross margin was 55.6% as-reported and 61.7% on a non-GAAP adjusted basis in the first quarter of 2025, compared with 59.0% as-reported and 62.1% on a non-GAAP adjusted basis in the first quarter of 2024. Lower reported gross margin in the first quarter was due to higher year-over-year amortization expense related to the acquisition of intangibles in the prior year. The year-over-year decline in non-GAAP Adjusted gross margin was primarily due to unfavorable price.

 

Net income for the first quarter of 2025 was $87 million, or $0.33 per diluted share, compared with $201 million, or $0.78 per diluted share, in the first quarter of 2024. For the first quarter of 2025, non-GAAP Adjusted net income was $265 million, or $1.02 per diluted share, compared with $315 million, or $1.22 per diluted share, in 2024.

 

 4 

 

 

Non-GAAP Adjusted EBITDA margin was 32.0% in the first quarter of 2025 compared with 33.2% in the first quarter of 2024. The lower Adjusted EBITDA margin was primarily driven by the decline in Adjusted gross profit; non-GAAP operating expenses were down 1% year-over-year.

 

Capital Allocation

 

Today, Organon’s Board of Directors declared a quarterly dividend of $0.02 for each issued and outstanding share of the company's common stock. This is a revision from the company's prior quarterly dividend rate of $0.28 per share. The dividend is payable on June 12, 2025, to stockholders of record at the close of business on May 12, 2025.

 

As of March 31, 2025, cash and cash equivalents were $547 million, and debt was $8.96 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.

 

 5 

 

 

Full year 2025 financial guidance is presented below on a non-GAAP basis, except revenue.

 

   Previous Guidance as of
February 13, 2025
  Current Guidance
Revenue  $6.125B-$6.325B  Unchanged
FX translation headwind  ~$200M  Unchanged, but with potential upside at current rates
Adjusted gross margin  60.0%-61.0%  Unchanged
SG&A  Mid 20% range  Unchanged
R&D  Upper single-digit  Unchanged
IPR&D*  -  $6 million
Adjusted EBITDA margin (Non-GAAP)  31.0%-32.0%  Unchanged
Interest  ~$510M  Unchanged
Depreciation  ~$135M  Unchanged
Effective non-GAAP tax rate  22.5%-24.5%  Unchanged
Fully diluted weighted average shares outstanding  ~263M  Unchanged

 

*The company does not provide guidance for forward-looking IPR&D and milestone expense. The $6 million of IPR&D expense in current guidance reflects IPR&D expense recorded through March 31, 2025.

 

Webcast Information

 

Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its first quarter 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://registrations.events/direct/Q4I585113

 

 6 

 

 

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.

 

About Organon

 

Organon is an independent global healthcare company with a primary mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers over 70 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical partners and innovators looking to commercialize their products by leveraging its scale and agile presence in fast growing international markets.

 

Organon has geographic scope with significant 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 LinkedIn, Instagram, 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 EBITDA margin, 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. Please refer to Table 4 and Table 5 of this press release for additional information, including relevant definitions and reconciliations of non-GAAP financial measures contained herein to the most directly comparable GAAP measures.

 

 7 

 

 

In addition, the company’s full-year 2025 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’s management uses the non-GAAP financial measures described above to evaluate the company’s performance and to guide operational and financial decision making. Further, the company’s management 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.

 

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 expectations regarding regulatory approvals (including the timing and outcome thereof) and product launch dates, potential benefits of Organon’s non-U.S. manufacturing locations, full-year 2025 guidance estimates and predictions regarding other financial information and metrics, expectations regarding Organon’s collaborations with third parties, and franchise and product performance and strategy expectations for future periods. Forward-looking statements may be identified by words such as “guidance,” potential,” “should,” “continue,” “will,” “continue,” “expects,” “intends,” “plans,” “believes,” “future,” “estimates,” “opportunity,” “path,” 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.

 

 8 

 

 

Risks and uncertainties include, but are not limited to, expanded brand and class competition in the markets in which Organon operates; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including any potential pharmaceutical sector tariffs), trade sanctions or similar restrictions by the United States or other governments; changes in U.S. and foreign federal, state and local governmental funding allocations including the timing and amounts allocated to Organon’s customers and business partners; economic factors over which Organon has no control, including changes in inflation, interest rates, recessionary pressures, and foreign currency exchange rates; market volatility, downgrades to the U.S. government’s sovereign credit rating or its perceived creditworthiness, changing political or geopolitical conditions, market contraction, boycotts, and sanctions, as well as Organon’s ability to successfully manage uncertainties related to the foregoing; difficulties with performance of third parties Organon relies on for its business growth; the failure of any supplier to provide substances, materials, or services as agreed; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as Organon’s products lose patent protection; any failure by Organon to retain market exclusivity for Nexplanon or to obtain an additional period of exclusivity in the United States for Nexplanon subsequent to the expiration of the rod patents in 2027; the continued impact of the September 2024 LOE for Atozet; restructurings or other disruptions at the U.S. Food and Drug Administration (“FDA”), the U.S. Securities and Exchange Commission (“SEC”) and other U.S. and comparable government agencies; difficulties and uncertainties inherent in the implementation of Organon’s acquisition strategy or failure to recognize the benefits of such acquisitions; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; the impact of higher selling and promotional costs; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of our products and related intellectual property, environmental regulations, and the enforcement thereof affecting Organon’s business; efficacy, safety or other quality concerns with respect to our marketed products, whether or not scientifically justified, leading to product recalls, withdrawals or declining sales; delays or failures to demonstrate adequate efficacy and safety of Organon’s product candidates in pre-clinical and clinical trials, which may prevent or delay the development, approval, clearance, or commercialization of Organon’s product candidates; future actions of third parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing health care insurance coverage; legal factors, including product liability claims, antitrust litigation and governmental investigations, including tax disputes, environmental claims and patent disputes with branded and generic competitors, any of which could preclude commercialization of products or negatively affect the profitability of existing products; lost market opportunity resulting from delays and uncertainties in clinical trials and the approval or clearance process of the FDA and other regulatory authorities; the failure by Organon or its third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations, which could lead to a delay in regulatory approval or commercial marketing of Organon’s products; cyberattacks on, or other failures, accidents, or security breaches of, Organon’s or third-party providers’ information technology systems, which could disrupt Organon’s operations and those of third parties upon which it relies; increased focus on privacy issues in countries around the world, including the United States, the European Union, and China, and a more difficult legislative and regulatory landscape for privacy and data protection that continues to evolve with the potential to directly affect Organon’s business, including recently enacted laws in a majority of states in the United States requiring security breach notification; changes in tax laws including changes related to the taxation of foreign earnings; the impact of any future pandemic, epidemic, or similar public health threat on Organon’s business, operations and financial performance; loss of key employees or inability to identify and recruit new employees; changes in accounting pronouncements promulgated by standard-setting or regulatory bodies, including the Financial Accounting Standards Board and the SEC, that are adverse to Organon; and volatility of commodity prices, fuel, shipping rates that impact the costs and/or ability to supply Organon’s products.

 

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 SEC, including the company’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov).

 

 9 

 

 

TABLE 1

 

Organon & Co. 

Condensed Consolidated Statement of Income

(Unaudited, $ in millions except shares in thousands and per share amounts)

 

   Three Months Ended
March 31,
 
   2025   2024 
Revenues  $1,513   $1,622 
Cost of sales   672    665 
Gross Profit   841    957 
           
Selling, general and administrative   420    431 
Research and development   96    112 
Acquired in-process research and development and milestones   6    15 
Restructuring costs   86    23 
Interest expense   124    131 
Exchange (gains) losses   (4)   6 
Other expense, net   12    3 
Income before income taxes   101    236 
Income tax expense   14    35 
Net income  $87   $201 
           
Earnings per share:          
Basic  $0.34   $0.78 
Diluted  $0.33   $0.78 
           
Weighted average shares outstanding:          
Basic   257,862    255,695 
Diluted   261,001    258,362 

 

 

 

TABLE 2

 

Organon & Co.

Sales by top products

(Unaudited, $ in millions)

 

   Three Months Ended March 31, 
   2025   2024 
($ in millions)  U.S.   Int’l   Total   U.S.   Int’l   Total 
Women’s Health                              
Nexplanon/Implanon NXT  $176   $72   $248   $153   $67   $220 
Follistim AQ   35    34    69    11    35    46 
NuvaRing   6    16    22    16    22    38 
Ganirelix Acetate Injection   5    23    27    6    23    29 
Marvelon/Mercilon       39    39        33    33 
Jada   15        15    13        13 
Other Women’s Health (1)   15    27    43    15    28    43 
Biosimilars                              
Renflexis   44    12    57    55    14    69 
Hadlima   33    14    47    22    8    30 
Ontruzant   4    14    18    8    31    39 
Brenzys       14    14        24    24 
Aybintio       5    5        8    8 
Established Brands                              
Cardiovascular                              
Atozet       77    77        132    132 
Zetia   1    84    85    2    82    84 
Cozaar/Hyzaar   2    53    55    3    65    67 
Vytorin   1    22    23    1    27    28 
Rosuzet       4    4        16    16 
Other Cardiovascular (1)       30    30        37    38 
Respiratory                              
Singulair   2    72    74    2    95    98 
Nasonex       71    72        77    77 
Dulera   34    10    43    43    13    56 
Clarinex       34    34    1    36    37 
Other Respiratory (1)   10    3    13    7    3    9 
Non-Opioid Pain, Bone and Dermatology                              
Arcoxia       62    62        75    75 
Fosamax   1    32    33    1    38    40 
Diprospan       30    30        29    29 
Vtama   20    4    24             
Other Non-Opioid Pain, Bone and Dermatology (1)   4    65    68    5    68    72 
Other                              
Propecia   1    24    26    2    21    23 
Emgality/Rayvow       32    32        10    10 
Proscar       24    24        26    26 
Other (1)   3    76    78    5    79    84 
Other (2)       22    22        29    29 
Revenues  $412   $1,101   $1,513   $371   $1,251   $1,622 

 

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.

(2) Other includes manufacturing sales to third parties.

 

 

 

TABLE 3

 

Organon & Co.

Sales by geographic area

(Unaudited, $ in millions)

 

   Three Months Ended
March 31,
 
   2025   2024 
Europe and Canada  $376   $450 
United States   412    371 
Asia Pacific and Japan   251    287 
China   204    206 
Latin America, Middle East, Russia, and Africa   240    274 
Other (1)   30    34 
Revenues  $1,513   $1,622 

 

(1) Other includes manufacturing sales to third parties.

 

 

 

TABLE 4

 

Organon & Co.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics
(Unaudited, $ in millions)

 

   Three Months Ended
March 31,
 
   2025   2024 
GAAP Gross Profit  $841   $957 
Adjusted for:          
Spin-related costs (1)       3 
Manufacturing network costs (2)   29    10 
Stock-based compensation   4    4 
Amortization   50    33 
Acquisition-related costs (3)   9     
Other   1     
Adjusted Non-GAAP Gross Profit  $934   $1,007 

 

(1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5.

(2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to Table 5.

(3) Acquisition-related costs relate to costs from the acquisition of Dermavant. For additional details refer to Table 5.

 

   Three Months Ended
March 31,
 
   2025   2024 
GAAP Gross Margin   55.6%   59.0%
Total impact of Non-GAAP adjustments   6.1%   3.1%
Adjusted Non-GAAP Gross Margin   61.7%   62.1%

 

   Three Months Ended
March 31,
 
   2025   2024 
GAAP Selling, general and administrative expenses  $420   $431 
Adjusted for:          
Spin-related costs (1)       (40)
Stock-based compensation   (16)   (18)
Restructuring related charges   (6)    
Other   (3)    
Adjusted Non-GAAP Selling, general and administrative expenses  $395   $373 

 

(1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5.

 

 

 

TABLE 4

 

Organon & Co.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Continued)

(Unaudited, $ in millions except per share amounts)

 

   Three Months Ended
March 31,
 
   2025   2024 
GAAP Research and development expenses  $96   $112 
Adjusted for:          
Spin-related costs (1)       (2)
Manufacturing network costs (2)   (3)    
Stock-based compensation   (4)   (4)
Other   (1)    
Adjusted Non-GAAP Research and development expenses  $88   $106 

 

(1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5.

(2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to Table 5.

 

   Three Months Ended
March 31,
 
   2025   2024 
GAAP Reported Net Income  $87   $201 
Adjusted for:          
Cost of sales adjustments   93    50 
Selling, general and administrative adjustments   25    58 
Research and development adjustments   8    6 
Restructuring   86    23 
Change in fair value of contingent consideration   11     
Other expense, net   4    4 
Tax impact on adjustments above(1)   (49)   (27)
Non-GAAP Adjusted Net Income  $265   $315 

 

(1) For the three months ended March 31, 2025 and 2024, the GAAP income tax rates were 13.4% and 14.7%, respectively, and the non-GAAP income tax rates were 19.2% and 16.4%, 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
March 31,
 
   2025   2024 
GAAP Diluted Earnings per Share  $0.33   $0.78 
Total impact of Non-GAAP adjustments   0.69    0.44 
Non-GAAP Diluted Earnings per Share  $1.02   $1.22 

 

 

 

TABLE 5

 

Organon & Co. 

Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA 

(Unaudited, $ in millions)

 

   Three Months Ended
March 31,
 
   2025   2024 
GAAP Reported Net Income  $87   $201 
Depreciation (1)   32    30 
Amortization   50    33 
Interest expense   124    131 
Income tax expense   14    35 
EBITDA (Non-GAAP)  $307   $430 
Restructuring and related charges   92    23 
Spin-related costs (2)       49 
Manufacturing network related (3)   36    10 
Acquisition-related costs (4)   9     
Change in contingent consideration   11     
Other costs   5     
Stock-based compensation   24    26 
Adjusted EBITDA (Non-GAAP)  $484   $538 
Adjusted EBITDA margin (Non-GAAP)   32.0%   33.2%
       
(1) Excludes accelerated depreciation included in one-time costs.
(2) Spin-related costs reflect certain costs incurred in connection with activities taken to separate Organon from Merck & Co., Inc., Rahway, NJ, US. These costs include, but are not limited to, $21 million for the three months ended March 31, 2024, for information technology infrastructure, primarily related to the implementation of a stand-alone enterprise resource planning system and redundant software licensing costs, as well as $14 million for the three months ended March 31, 2024, associated with temporary transition service agreements with Merck & Co., Inc., Rahway, NJ, US.
(3) Manufacturing network related costs, including 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.
(4) Acquisition related costs for the three months ended March 31, 2025, reflect the amortization pertaining to the fair value inventory purchase accounting adjustment for the Dermavant transaction.
       
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.

 

 

Exhibit 99.2

 

First Quarter 2025 Earnings Organon

 

Disclaimer statement Cautionary Note Regarding Forward - Looking Statements Except for historical information, 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 expectations about Organon’s future financial performance and prospects, including exp ectations regarding regulatory approvals (including the timing and outcome thereof) and product launch dates, potential benefits of Organon’s non - U.S. manufacturing locations, full - year 2025 guidance estimates an d predictions regarding other financial information and metrics, expectations regarding Organon’s collaborations with third parties, and franchise and product performance and strategy expectations for future perio ds. Forward - looking statements may be identified by words such as “guidance,” potential,” “should,” “continue,” “will,” “continue,” “expects,” “intends,” “plans,” “believes,” “future,” “estimates,” “opportunity,” “p ath ,” 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 pr ove 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, expanded brand and class competition in the markets in which Organon op erates; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including any potential pharmaceutical sector tariffs), trade sanctions or similar restrictions by the United States or other governments; changes in U.S. and foreign federal, state and local governmental funding allocations including the timing and amounts allocated to Organon’s customers a nd business partners; economic factors over which Organon has no control, including changes in inflation, interest rates, recessionary pressures, and foreign currency exchange rates; market volatility, downgra des to the U.S. government’s sovereign credit rating or its perceived creditworthiness, changing political or geopolitical conditions, market contraction, boycotts, and sanctions, as well as Organon’s ability to s ucc essfully manage uncertainties related to the foregoing; difficulties with performance of third parties Organon relies on for its business growth; the failure of any supplier to provide substances, materials, or services as agreed; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as Organon’s produc ts lose patent protection; any failure by Organon to retain market exclusivity for Nexplano n® (etonogestrel implant) or to obtain an additional period of exclusivity in the United States for Nexplanon subsequent to the expiration of the rod patents in 2027; the continued impact of the September 2024 LOE for Atozet (ezetimibe and atorvastatin); restructurings or other disruptions at the U.S. Food and Drug Administration (“FDA”), the U.S. Se curities and Exchange Commission (“SEC”) and other U.S. and comparable government agencies; difficulties and uncertainties inherent in the implementation of Organon’s acquisition strate gy or failure to recognize the benefits of such acquisitions; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Med ica re, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; the impact of higher selling and promotional costs; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of our products and related intellect ual property, environmental regulations, and the enforcement thereof affecting Organon’s business; efficacy, safety or other quality concerns with respect to our marketed products, whether or not scientifically jus tif ied, leading to product recalls, withdrawals or declining sales; delays or failures to demonstrate adequate efficacy and safety of Organon’s product candidates in pre - clinical and clinical trials, which may prevent or delay the development, approval, clearance, or commercialization of Organon’s product candidates; future actions of third parties, including significant changes in customer relationships or changes in th e b ehavior and spending patterns of purchasers of health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing heal th care insurance coverage; legal factors, including product liability claims, antitrust litigation and governmental investigations, including tax disputes, environmental claims and patent disputes with branded and generic co mpe titors, any of which could preclude commercialization of products or negatively affect the profitability of existing products; lost market opportunity resulting from delays and uncertainties in clinical trials an d t he approval or clearance process of the FDA and other regulatory authorities; the failure by Organon or its third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations, wh ich could lead to a delay in regulatory approval or commercial marketing of Organon’s products; cyberattacks on, or other failures, accidents, or security breaches of, Organon’s or third - party providers’ information technolo gy systems, which could disrupt Organon’s operations and those of third parties upon which it relies; increased focus on privacy issues in countries around the world, including the United States, the European Union, and China, and a more difficult legislative and regulatory landscape for privacy and data protection that continues to evolve with the potential to directly affect Organon’s business, including recently enacted laws in a majority of states in the United States requiring security breach notification; changes in tax laws including changes related to the taxation of foreign earnings; the impact of any future pandemic, epidemic, or simil ar public health threat on Organon’s business, operations and financial performance; loss of key employees or inability to identify and recruit new employees; changes in accounting pronouncements promulgated by standar d - s etting or regulatory bodies, including the Financial Accounting Standards Board and the SEC, that are adverse to Organon; and volatility of commodity prices, fuel, shipping rates that impact the costs and/or a bil ity to supply Organon’s products. The company undertakes no obligation to publicly update any forward - looking statement, whether as a result of new information, f uture 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 SEC, including the company ’s most recent Annual Report on Form 10 - K and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov). 2

 

Disclaimer statement, cont. Cautionary Note Regarding Non - GAAP Financial Measures This presentation contains “non - GAAP financial measures,” which are financial measures that either exclude or include amounts t hat 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”). Speci fic ally, the company makes use of the non - GAAP financial measures Adjusted EBITDA, Adjusted EBITDA margin, Adjusted gross margin, Adjusted gross profit, Adjusted net income, and Adjusted dilu ted EPS, which are not recognized terms under GAAP and are presented only as a supplement to the company’s GAAP financial statements. This presentation also provides certain measures t hat 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 com paring 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 GAA P. 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 Slides 17 - 19 of this presentation for additional information, including relevant definitions and reconciliations of non - GAAP financial measures contained herein to the most directly comparable GAAP measures. In addition, the company’s full - year 2025 guidance measures (other than revenue) are provided on a non - GAAP basis because the co mpany 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 on going 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. Further, the company’s management believes that these non - GAAP financial measures, which exclude certain items, help to enhance its ability t o meaningfully communicate its underlying business performance, financial condition and results of operations. 3 See Slides 17 - 19 of this presentation for a reconciliation of non - GAAP measures.

 

First Quarter 2025 highlights 4 • Revenue of $1.5 billion, down 4% ex - FX, consistent with phasing of LOE of Atozet • Diluted EPS of $0.33; Adj. Diluted EPS of $1.02 • Adj. EBITDA of $484 million, representing 32.0% Adjusted EBITDA margin • Full year 2025 financial guidance affirmed See Slides 17 - 19 of this presentation for a reconciliation of non - GAAP measures. LOE = Loss of Exclusivity

 

Totals may not foot due to rounding, and percentages are computed using unrounded amounts. (1) “Other” includes manufacturing sales to third parties. (2) Above chart based on Q1 2025 revenue ~75% of FY sales generated ex - US (2) U.S. represents ~1/4 of total Organon revenue 5 Other (1) , 2% LAMERA, 16%

 

Women’s Health Women’s Health Ex - FX VPY Act VPY Q1 - 24 Q1 - 25 Revenues $ mil 14% 13% 220 248 Nexplanon ® (contraception) 21% 19% 33 39 Marvelon / Mercilon (contraception) (41)% (43)% 38 22 NuvaRing ® (contraception) 52% 49% 46 69 Follistim AQ ® (fertility) (4)% (6)% 29 27 Ganirelix Acetate Injection (fertility) 20% 20% 13 15 Jada ® (device) 4% — % 43 43 Other Women's Health products 12% 10% 422 463 Total Women's Health • Franchise growth of 12% • Nexplanon on track to achieve >$1 billion of revenue in 2025 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 . 6

 

Biosimilars Biosimilars Ex - FX VPY Act VPY Q1 - 24 Q1 - 25 Revenues $ mil (17)% (18)% 69 57 Renflexis ® 57% 55% 30 47 Hadlima ® (54)% (54)% 39 18 Ontruzant ® (35)% (39)% 24 14 Brenzys (30)% (33)% 8 5 Aybintio (15)% (17)% 170 141 Biosimilars 7 • Renflexis and Ontruzant at mature phase of lifecycle • Hadlima, Tofidence partial offsets in 2025 • Potential U.S. denosumab launch late 2025 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 . In March 2025 , Organon acquired from Biogen the regulatory and commercial rights in the United States for Tofidence® (tocilizumab - bavi), a biosimilar to Actemra (tocilizumab) .

 

Established Brands Established Brands Ex - FX VPY Act VPY Q1 - 24 Q1 - 25 Revenues $ mil (22)% (25)% 365 274 Cardiovascular (13)% (15)% 277 236 Respiratory 4% 1% 216 217 Non - Opioid Pain, Bone & Derm 16% 11% 144 159 Other (1) (8)% (11)% 1,001 887 Total Est. Brands 8 • Emgality, Vtama offsetting factors to Atozet LOE in 2025 • Vtama Q1 sales of $24M; on track to deliver $150M of revenue for full year Totals may not foot due to rounding . (1) “Other” includes sales of Emgality ® (galcanezumab - gnlm) in those countries in which Organon has the rights to distribute and promote the product. Emgality is a trademark of Eli Lilly and Company (used under license) . LOE = Loss of Exclusivity

 

(7%) as reported (4%) at constant currency $ mil 9 (1) LOE = Loss of Exclusivity (2) VBP = Volume Based Procurement (3) “Other” includes manufacturing sales to third parties. (3) (1) (2) ~ ~ ~ ~ ~ ~ ~(280) bps headwind Atozet LOE headwind will persist through Q3 2025

 

Strong Q1 margin driven by timing of op - ex spend Actual VPY Q1 - 24 Q1 - 25 All numbers presented on non - GAAP basis except revenue and IPR&D (1) (7)% 1,622 1,513 Revenue (6)% 615 579 Cost of sales (7)% 1,007 934 Adjusted Gross profit 6% 373 395 Selling, general and administrative (17)% 106 88 R&D — % 15 6 Acquired IPR&D and milestones (22)% 121 94 Total research and development including IPR&D and milestones (1)% 494 489 Total operating expense (10)% 538 484 Adjusted EBITDA (17)% 1.22 1.02 Adjusted diluted EPS 62.1% 61.7% Adjusted Gross margin 33.2% 32.0% Adjusted EBITDA margin (1) See Slides 17 - 19 of this presentation for a reconciliation of non - GAAP measures to their respective GAAP measures. Cost of sales excludes amorti zation. 10

 

11 Q1 2024 Q1 2025 (USD millions) $538 $484 Adjusted EBITDA (65) (41) Less: Net cash interest expense (50) (25) Less: Cash taxes (291) (240) Less: Change in net working capital (23) (32) Less: CapEx $109 $146 Free Cash Flow Before One - Time Costs (62) — Less: One - time spin - related costs (41) (75) Less: MSA exit, restructuring, legal settlement, other one - time costs (1) $6 $71 Free Cash Flow (2) Q1 FCF seasonally light, but improved over 2024 1) 2025 includes cash payments associated with restructuring initiatives ($15M), planned exits from supply agreements with Me rck & Co., Inc., Rahway, NJ. ($40M), and the final payment on the Microspherix settlement ($20M). 2024 included cash payments for planne d e xits from supply agreements with Merck & Co., Inc., Rahway, NJ. ($14M), and cash payments associated with restructuring ($27M). (2) Free cash flow represents net cash flows provided by operating activities plus capital expenditures and the effect of exc han ge rate changes on cash and cash equivalents. Year - over - year improvement driven by: • Lower interest rates, timing of interest and cash tax payments • Active working capital management • 2024 marked conclusion of spin - related costs

 

12 Net leverage ratio ~4.3x at March 31, 2025 * The definition of net debt is in the company's credit agreement and excludes unamortized fees, but includes capitalized lea se obligations. Additionally, the LTM EBITDA calculation excludes acquired IPR&D and milestone expense. (1) Debt figures are net of discounts and unamortized fees of, $97 million and $93 million as of December 31, 2024 and March 31, 2025, respectively. ~ ~ ~

 

Growth in Nexplanon , Emgality and Vtama offsets to LOE, pricing $ mil 13 ( 1) LOE = Loss of Exclusivity (2) VBP = Value Based Procurement (3) “Other” includes manufacturing sales to third parties. Emgality is a trademark of Eli Lilly and Company (used under license) . (1) (2) (3) (4.3%) to (1.2%) as reported (1.2%) to +1.9% at constant currency Potential upside to estimate if current rates hold ~ ~ ~ ~ ~ ~

 

Full Year 2025 Guidance 14 Current Guidance Prior Guidance as of February 13, 2025 Provided on a non - GAAP basis, except revenue Unchanged $6.125B - $6.325B Revenue Unchanged, but with potential upside at current rates ~$200M FX translation headwind Unchanged 60.0% - 61.0% Adjusted gross margin Unchanged Mid 20% range SG&A Unchanged Upper single - digit R&D $6 million - IPR&D* Unchanged 31.0% - 32.0% Adjusted EBITDA margin (Non - GAAP) Unchanged ~$510M Interest Unchanged ~$135M Depreciation Unchanged 22.5% - 24.5% Effective non - GAAP tax rate Unchanged ~263M Fully diluted weighted average shares outstanding * The company does not forecast a forward - looking view of IPR&D and milestone expense. The $6 million of IPR&D expenses in curre nt guidance reflects IPR&D expense recorded to date as of March 31, 2025.

 

Q&A

 

Appendix

 

Reconciliation of GAAP Reported to Non - GAAP Adjusted Metrics ($ in millions) Q1 2024 Q1 2025 $ 957 $ 841 GAAP Gross Profit Adjusted for: 3 — Spin - related costs (1) 10 29 Manufacturing network costs (2) 4 4 Stock - based compensation 33 50 Amortization — 9 Acquisition - related costs (3) — 1 Other $ 1,007 $ 934 Adjusted Non - GAAP Gross Profit (1) Spin - related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to t he EBITDA reconciliation on page 19 . (2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc. , R ahway NJ, US. For additional details refer to the EBITDA reconciliation on page 19 . (3) Acquisition - related costs relate to costs from the acquisition of Dermavant Sciences Ltd. (“ Dermavant “). For additional details refer to the EBITDA reconciliation on page 19 . Q1 2024 Q1 2025 59.0 % 55.6 % GAAP Gross Margin 3.1 % 6.1 % Total impact of Non - GAAP adjustments 62.1 % 61.7 % Adjusted Non - GAAP Gross Margin Q1 2024 Q1 2025 $ 431 $ 420 GAAP Selling, general and administrative expenses Adjusted for: (40) — Spin - related costs (1) (18) (16) Stock - based compensation — (6) Restructuring related charges — (3) Other $ 373 $ 395 Adjusted Non - GAAP Selling, general and administrative expenses (1) Spin - related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to t he EBITDA reconciliation on page 19 . 17

 

Reconciliation of GAAP Reported to Non - GAAP Adjusted Metrics ($ in millions, except per share amounts) Q1 2024 Q1 2025 $ 112 $ 96 GAAP Research and development expenses Adjusted for: (2) — Spin - related costs (1) — (3) Manufacturing network costs (2) (4) (4) Stock - based compensation — (1) Other $ 106 $ 88 Adjusted Non - GAAP Research and development expenses (1) Spin - related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to t he EBITDA reconciliation on page 19 . (2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc. , R ahway NJ, US. For additional details refer to the EBITDA reconciliation on page 19 . Q1 2024 Q1 2025 $ 201 $ 87 GAAP Reported Net Income Adjusted for: 50 93 Cost of sales adjustments 58 25 Selling, general and administrative adjustments 6 8 Research and development adjustments 23 86 Restructuring — 11 Change in contingent consideration 4 4 Other expense, net (27) (49) Tax impact on adjustments above (1) $ 315 $ 265 Non - GAAP Adjusted Net Income (1) For the three months ended March 31, 2025 and 2024, the GAAP income tax rates were 13.4% and 14.7%, respectively, and the no n - GAAP income tax rates were 19.2% and 16.4%, respectively. These adjustments represent the estimated tax impacts on the reconciling items by applying the statutory ra te and applicable law of the originating territory of the non - GAAP adjustments. Q1 2024 Q1 2025 $ 0.78 $ 0.33 GAAP Diluted Earnings per Share 0.44 0.69 Total impact of Non - GAAP adjustments $ 1.22 $ 1.02 Non - GAAP Diluted Earnings per Share 18

 

GAAP Net Income to Adjusted EBITDA Q1 2024 Q1 2025 Unaudited, $ in millions $ 201 $ 87 GAAP Reported Net Income 30 32 Depreciation (1) 33 50 Amortization 131 124 Interest expense 35 14 Income tax expense $ 430 $ 307 EBITDA (Non - GAAP) 23 92 Restructuring and related charges 49 — Spin - related costs (2) 10 36 Manufacturing network related (3) — 9 Acquisition - related costs (4) — 11 Change in contingent consideration — 5 Other costs 26 24 Stock - based compensation $ 538 $ 484 Adjusted EBITDA (Non - GAAP) 33.2 % 32.0 % Adjusted EBITDA margin (Non - GAAP) 19 (1) Excludes accelerated depreciation included in one - time costs. (2) Spin - related costs reflect certain costs incurred in connection with activities taken to separate Organon from Merck & Co., Inc., Rahway, NJ, US. These costs include, but are not limited to, $21 million for the three months ended March 31, 2024, for information technology infrastructure, primarily related to the implementation of a stand - alone enterprise resource planning system and redundant software licensing costs, as well as $14 million for the three months ended March 31, 2024, associated with temporary transition service agreements with Merck & C o., Inc., Rahway, NJ, US. (3) Manufacturing network related costs, including exiting of temporary manufacturing and supply agreements with Merck & Co., In c., Rahway, NJ, US, reflect accelerated depreciation, exit premiums, technology transfer costs, stability and qualification batch costs, and third - party contractor costs. (4) Acquisition related costs for the three months ended March 31, 2025, reflect the amortization pertaining to the fair value i nventory purchase accounting adjustment for the Dermavant transaction. As the costs described in (1) through (4) above are directly related to the separation of Organon and acquisition related act ivi ties 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 wil l enhance an investor's understanding of the company's ongoing operating performance.

 

Ex - FX VPY Actual VPY Q1 - 24 Q1 - 25 $ mil 11% 11% 371 412 United States (12)% (16)% 450 376 Europe and Canada (9)% (12)% 287 251 Asia Pacific and Japan (8)% (12)% 274 240 Latin America, Middle East, Russia and Africa — % (1)% 206 204 China (13)% (17)% 34 30 Other (1) (4)% (7)% 1,622 1,513 Total Revenues Totals may not foot due to rounding, and percentages are computed using unrounded amounts. (1) “Other” includes manufacturing sales to third parties. Geographic revenue performance 20

 

Ex - FX VPY Actual VPY Q1 2024 Q1 2025 $ millions 12% 10% 422 463 Women’s Health (15)% (17)% 170 141 Biosimilars (8)% (11)% 1,001 887 Est. Brands (19)% (23)% 29 22 Other (1) (4)% (7)% 1,622 1,513 Total Revenues Totals may not foot due to rounding and percentages are computed using unrounded amounts. (1) “Other” includes manufacturing sales to third parties. 21 Franchise performance

 

Number of products 14 6 56 Women’s Health Biosimilars Established Brands Broad and diverse portfolio 22 Emgality is a trademark of Eli Lilly and Company (used under license) . TM