EX-99.2 3 tm2513730d1_ex99-2.htm EXHIBIT 99.2

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