Alendronate Sodium

For many years, the manufacturer of Fosamax did not inform patients of a known, important adverse reaction to their drug: an atypical femoral fracture (AFF). The thigh bone (femur) can break spontaneously, with no warning and usually during a low-impact movement, like walking or standing up. These injuries usually require surgery. A class action lawsuit has been winding its way through the courts that addresses the question if those patients who experienced the AFF have the right to sue. This case about the claim that Merck failed to warn about AFF reaches past this suit to potentially change pharmaceutical companies’ relationship with the FDA. The case is Merck Sharp & Dohme Corp., V. Doris Albrecht, et.at. The case was scheduled to be heard in Philadelphia in the Court of Appeals for the Third Circuit on March 5th. Three former officials of the FDA and MedShadow Foundation, of which I am founder and president, filed an amicus brief with this court and in the previous US Supreme Court hearing. These, and other facts in this article, are supported by the amicus brief filed with the Supreme Court: An amicus brief can be filed by an individual, a group of individuals, or organizations that offer insight or a unique point of view that has bearing on the case. Fosamax belongs to a class of drugs called “bisphosphonates,” which are commonly used to treat osteoporosis. Respondents in this case are patients who allege that Fosamax (alendronate sodium) caused them to suffer atypical femoral fractures, which are incapacitating fractures that result from little or no trauma in which the thigh bone often breaks in two. There are several legal questions in this suit and many nuances to each of the questions it presents. From my courtside seat as a patients’-rights advocate (and not a lawyer), the most important issue is a patient’s right to be informed of and to understand the risks, along with the benefits, of any drug. Traditionally that information is included in the prescribing “label,” the written communication enclosed with the drug (and in several other places). In general, if a side effect or adverse reaction is listed on the label, patients’ ability to sue for damages is blocked. After all, they were warned and presumably felt the risk was worth the drug’s benefit. Additionally, if a drug company is specifically told by the FDA that the adverse risk does not need to be included on the label, the drug company is again protected from lawsuits by patients. This case is about the women who experienced so-called “Fosamax fractures” and whether they have the right to sue Merck for “failure to warn.” Fosamax was approved by the FDA in 1995 to treat osteoporosis. Records show that Merck, the manufacturer of Fosamax, received reports of atypical femoral fractures as early as 1999; and subsequent articles, case studies, and reports continued for several years. With this information, Merck could have added a warning through either of two processes without FDA permission as provided for in The Federal Food, Drug, and Cosmetic Act (outlined in the amicus curiae). But, Merck did not act for nine years. In 2008, Merck was asked by the FDA to submit a proposed warning to be added to the label regarding these risky fractures. But the proposed warning submitted by Merck described a less serious stress fracture, which is very different from an atypical femoral fracture. The FDA’s response was clear: the agency could not approve the warning “in its present form.” Finally, about two years later in 2010, the FDA directed Merck to add three specifically worded paragraphs describing atypical femoral fractures to the “Warnings and Precautions” section of the label. Merck is claiming that the FDA’s letter rejecting the proposed warning was a final letter which did not allow Merck to add the warning about atypical femoral fractures. The FDA does not agree. Did Merck phrase the proposed warning about atypical femoral fractures in a way designed to be rejected by the FDA? Did the drug manufacturer hope to create protection from lawsuits that the FDA did not intend to give by poorly wording its first submission? If so, will other drug companies use the same tactic to avoid disclosing drug risks to patients and doctors? Under FDA regulations, drug manufacturers bear the responsibility for the content of its label at all times. The FDA has provided at least two methods for pharmaceutical companies to add warnings to their drug labels before or pending FDA approval of the warning. There are many additional nuances to the case that are not discussed here. The case may fail or prevail based on technical legal aspects. But there is a core value at stake here, that the Delaware courts, or the Supreme Court after this procedure, need to make clear: Patients have the right to know the risks and benefits of any drug they are prescribed, and the responsibility for that knowledge and message delivery lies with the manufacturer of said drug. When Merck decided not to include that information on the label, they chose not to disclose to patients a known and severe adverse risk. Patients should have the right to sue in those cases. They were denied information that might have changed their decision to use or not use the drug. And in the future, drug manufacturers should not be able to use Merck’s tactic to avoid informed decision making.

Full year 2023 revenue of $6.3 billion, up 1% as-reported and 3% at constant currency Full year 2023 diluted earnings per share of $3.99 and non-GAAP Adjusted diluted earnings per share of $4.14 Full year 2023 Adjusted EBITDA of $1.9 billion, representing a 31.0% Adjusted EBITDA margin Full year 2024 financial guidance ranges provided; full year revenue range of $6.2 billion to $6.5 billion and Adjusted EBITDA margin in the range of 31.0% to 33.0% JERSEY CITY, N.J.--(BUSINESS WIRE)-- Organon (NYSE: OGN) today announced its results for the fourth quarter and full year ended December 31, 2023. "As we move into 2024, our priorities are to deliver our third year of constant currency revenue growth and to achieve a stable to improving Adjusted EBITDA margin. Delivering this financial pro key for us to be able to continue advancing on our mission of a healthier every day for every woman. There’s a tremendous opportunity in women’s health to address significant unmet needs and we are well positioned at the forefront of that effort." Fourth Quarter 2023 Revenue in $ millions Q4 2023 Q4 2022 VPY VPY ex-FX Women’s Health $ 465 $ 433 7 % 8 % Biosimilars 199 134 49 % 48 % Established Brands 915 888 3 % 3 % Other (1) 19 30 (37 )% (42 )% Revenues $ 1,598 $ 1,485 8 % 8 % (1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties. For the fourth quarter of 2023, total revenue was $1,598 million, an increase of 8% on an as-reported basis as well as excluding impact of foreign currency (ex-FX), compared with the fourth quarter of 2022. Women’s Health revenue increased 7% on an as-reported basis, and increased 8% ex-FX in the fourth quarter of 2023 compared with the fourth quarter of 2022 driven primarily by strong growth in the company's fertility products, particularly Follistim AQ® (follitropin beta injection). Follistim grew 63% ex-FX in the fourth quarter due to a one-time buy-in as a result of the exit of the Interim Operating Model ("IOM") in the United States, increased demand in the U.S. that was largely tied to onboarding a new customer, as well as volume recovery in China tied to fertility patients returning to clinics following abating COVID-19 concerns. The Women's Health franchise also benefited from strong performance of oral contraceptives Marvelon™ (ethinylestradiol, desogestrel) and Mercilon™ (ethinylestradiol, desogestrel) which was driven in part by the reacquisition of rights in selected territories in Southeast Asia and China during 2022, as well as continued uptake of the Jada® system. Performance was partially offset by a 3% ex-FX decline in Nexplanon® (etonogestrel implant) primarily related to customer buying patterns associated with the company's decision to forgo its normal Nexplanon list-price increase in 2023, as well as a 12% ex-FX decrease in NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) which continues to be impacted by generic competition. Biosimilars revenue increased 49% on an as-reported basis and increased 48% ex-FX in the fourth quarter of 2023, compared with the fourth quarter of 2022 primarily driven by Ontruzant® (trastuzumab-dttb), which grew 76% ex-FX and benefited from favorable timing of tender phasing in Brazil, and Renflexis® (infliximab-abda), which grew 28% ex-FX primarily due to U.S. strong volume growth. Revenue of Hadlima™ (adalimumab-bwwd) more than doubled in the fourth quarter of 2023 compared with the fourth quarter of 2022 as a result of continued uptake since its July 2023 launch in the U.S. Established Brands revenue increased 3% as-reported and 3% ex-FX in the fourth quarter of 2023 despite the impacts of Volume Based Procurement (VBP) initiatives and a challenging operating environment in China. Growth in the quarter was driven by a 13% ex-FX increase in the respiratory portfolio. In the cardiovascular portfolio, continued growth in Atozet™ (ezetimibe and atorvastatin calcium) partially offset a decline in Cozaar®/Hyzaar® (losartan) products which are subject to ongoing generic competition. Fourth Quarter 2023 Profitability in $ millions, except per share amounts Q4 2023 Q4 2022 VPY Revenues $ 1,598 $ 1,485 8 % Cost of sales 683 594 15 % Gross profit 915 891 3 % Non-GAAP Adjusted gross profit (1) 964 937 3 % Adjusted EBITDA (1,2) 449 380 18 % Net income 546 108 406 % Non-GAAP Adjusted net income (1) 226 208 9 % Diluted Earnings per Share (EPS) 2.13 0.42 407 % Non-GAAP Adjusted diluted EPS (1) 0.88 0.81 9 % Acquired in-process research & development (IPR&D) and milestones — — — Per share impact to diluted EPS from acquired IPR&D and milestones — — — Q4 2023 Q4 2022 Gross margin 57.3 % 60.0 % Non-GAAP Adjusted gross margin (1) 60.3 % 63.1 % Adjusted EBITDA margin (1, 2) 28.1 % 25.6 % (1) See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures (2) Adjusted EBITDA and Adjusted EBITDA margin include no acquired IPR&D in the fourth quarter 2022 nor the fourth quarter 2023 Gross margin was 57.3% as-reported and 60.3% on an adjusted basis in the fourth quarter of 2023 compared with 60.0% as-reported and 63.1% on an adjusted basis in the fourth quarter of 2022. Unfavorable foreign exchange translation and to a lesser extent, product mix more than offset a favorable year-over-year comparison to the fourth quarter 2022 when the company took a market action on certain injectable steroid products. Adjusted EBITDA margin was 28.1% in the fourth quarter of 2023 compared with 25.6% in the fourth quarter of 2022 primarily due to lower year-over-year operating expenses and lower loss on foreign exchange translation attributable to the year-over-year comparison of the amount of the company's Euro-denominated debt covered under a net investment hedge program. Net income for the fourth quarter of 2023 was $546 million, or $2.13 per diluted share, compared with $108 million, or $0.42 per diluted share, in the fourth quarter of 2022. Non-GAAP Adjusted net income was $226 million, or $0.88 per diluted share, compared with $208 million, or $0.81 per diluted share, in 2022. Reported GAAP net income for the fourth quarter includes a net $476 million tax benefit resulting from the termination of a Swiss tax arrangement. Revenues in $ millions FY 2023 FY 2022 VPY VPY ex-FX Women’s Health $ 1,702 $ 1,673 2 % 3 % Biosimilars 593 481 23 % 24 % Established Brands 3,847 3,874 (1 )% 2 % Other(1) 121 146 (17 )% (19 )% Revenue $ 6,263 $ 6,174 1 % 3 % (1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA. Total revenue was $6.3 billion for full year 2023, an increase of 1% as-reported and an increase of 3% ex-FX, compared with the full year 2022. Women’s Health revenue increased 2% as-reported and 3% ex-FX for full year 2023 compared with 2022. Strong growth in the company's fertility portfolio, which was up 9% ex-FX for the full year, a 24% ex-FX increase in oral contraceptives Marvelon/Mercilon and continued uptake of the Jada System, were the strongest revenue contributors to the Women’s Health franchise in 2023. Together these factors more than offset an 11% ex-FX decline in NuvaRing, which continues to be impacted by generic competition. Modest growth of Nexplanon of 1% ex-FX for the full year reflects the impact of the limited participation of a tender in Mexico and customer buying patterns associated with the company's decision to forgo its normal list price increase for Nexplanon in 2023. Biosimilars revenue increased 23% as-reported and 24% ex-FX for full year 2023 compared with 2022, driven primarily by continued demand growth in the U.S. and Canada for Renflexis and favorable phasing of tenders in Brazil and increased demand for Ontruzant, partially offset by competitive pressures in Europe. Revenue for Established Brands declined 1% as-reported and increased 2% ex-FX for the full year 2023 despite VBP initiatives and a challenging operating environment in China as well as supply interruptions of certain of the company's injectable steroid products stemming from the market action taken earlier in the year. Performance was driven by 2% growth in volume across the portfolio, partially offset by 1% price pressure. The company expects flat performance in the Established Brands franchise for full year 2024 on an ex-FX basis. Full Year 2023 Profitability in $ millions, except per share amounts 2023 2022 VPY Revenues $ 6,263 $ 6,174 1 % Cost of sales 2,515 2,294 10 % Gross profit 3,748 3,880 (3 )% Non-GAAP Adjusted gross profit (1) 3,930 4,058 (3 )% Adjusted EBITDA (1,2) 1,944 2,085 (7 )% Net income 1,023 917 12 % Non-GAAP Adjusted net income (1) 1,061 1,284 (17 )% Diluted Earnings per Share (EPS) 3.99 3.59 11 % Non-GAAP Adjusted diluted EPS (1) 4.14 5.03 (18 )% Acquired in-process research & development (IPR&D) and milestones 8 107 (93 )% Per share impact to diluted EPS from acquired IPR&D and milestones (0.03 ) (0.33 ) (91 )% 2023 2022 Gross margin 59.8 % 62.8 % Non-GAAP Adjusted gross margin (1) 62.7 % 65.7 % Adjusted EBITDA margin (1, 2) 31.0 % 33.8 % (1) See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures (2) Adjusted EBITDA and Adjusted EBITDA margin include $8 million in 2023 and $107 million in 2022 related to acquired IPR&D and milestones Gross margin was 59.8% as-reported and 62.7% on an adjusted basis for full year 2023 compared with 62.8% as-reported and 65.7% on an adjusted basis for full year 2022. The year-over-year decrease in Adjusted gross margin reflects higher cost of sales due to foreign exchange translation and product mix, and to a lesser extent, higher employee-related and distribution-related costs. Adjusted EBITDA margin was 31.0% for the full year 2023 compared with 33.8% for the full year 2022. The year-over-year decrease was primarily a result of a lower Adjusted gross margin. Higher selling and promotional costs were mostly offset by lower total research and development spend, which includes in-process research and development (IPR&D). Net income for 2023 was $1.0 billion, or $3.99 per diluted share, compared with $917 million, or $3.59 per diluted share in 2022. Non-GAAP Adjusted net income was $1.1 billion or $4.14 per diluted share, compared with $1.3 billion, or $5.03 per diluted share in 2022. The year-over-year decline in net income was primarily due to higher interest expense due to increased interest rates, and accelerated amortization of capitalized financing costs associated with voluntary prepayments on the company’s U.S. dollar-denominated term loan. 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 March 14, 2024, to stockholders of record at the close of business on February 26, 2024. As of December 31, 2023, cash and cash equivalents were $693 million, and debt was $8.8 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. Full year 2024 financial guidance is presented below on a non-GAAP basis. For full year 2024, Organon expects constant currency revenue growth in the low-single-digit range and expects stable to improving Adjusted EBITDA margin, which Organon expects to achieve, in part, through operating expense management. 2024 Full Year Guidance Revenues $6.2B-$6.5B Adjusted gross margin 61.0% - 63.0% SG&A $1.5B - $1.7B R&D (excluding IPR&D) $400M - $500M Adjusted EBITDA margin 31.0% - 33.0% Interest ~$520M Depreciation ~$130M Effective non-GAAP tax rate 18.5% - 20.5% Fully diluted weighted average shares outstanding ~259M Webcast Information Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its fourth quarter and full year 2023 financial results. To listen to the event and view the presentation slides via webcast, join from the Organon Investor Relations website at . 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: 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 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 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 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. In addition, the company’s full-year 2024 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 2024 guidance estimates and predictions regarding other financial information and metrics, and franchise and product performance and strategy expectations for future periods. 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. 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 that 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 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; the impact of higher selling and promotional costs; any failure by Organon to obtain an additional period of market exclusivity in the United States for Nexplanon subsequent to the expiration of certain key patents in 2027; 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 most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site ( ). TABLE 1 Organon & Co. Condensed Consolidated Statement of Income (Unaudited, $ in millions except shares in thousands and per share amounts) Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 Revenues $ 1,598 $ 1,485 $ 6,263 $ 6,174 Costs, Expenses and Other Cost of sales 683 594 2,515 2,294 Selling, general and administrative 469 470 1,893 1,704 Research and development 134 142 528 471 Acquired in-process research and development and milestones — — 8 107 Restructuring costs 58 17 62 28 Interest expense 129 119 527 422 Exchange losses 17 32 42 11 Other expense, net 4 — 15 15 1,494 1,374 5,590 5,052 Income Before Income Taxes 104 111 673 1,122 Taxes on income (442 ) 3 (350 ) 205 Net Income 546 108 1,023 917 Earnings per Share: Basic $ 2.14 $ 0.42 $ 4.01 $ 3.61 Diluted $ 2.13 $ 0.42 $ 3.99 $ 3.59 Weighted Average Shares Outstanding: Basic 255,617 254,367 255,239 254,082 Diluted 256,590 255,390 256,270 255,169 TABLE 2 Organon & Co. Sales by top products (Unaudited, $ in millions) Three Months Ended December 31, Year Ended December 31, 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 $ 154 $ 76 $ 231 $ 172 $ 67 $ 239 $ 572 $ 257 $ 830 $ 573 $ 261 $ 834 Follistim AQ 51 31 83 26 25 50 125 136 262 105 124 229 NuvaRing 16 19 35 21 20 40 66 86 152 85 88 173 Ganirelix Acetate Injection 4 18 22 6 20 25 19 91 110 26 97 123 Marvelon/Mercilon — 37 37 — 24 24 — 134 134 — 110 110 Jada 13 — 13 8 — 8 43 — 43 20 — 20 Other Women's Health (1) 20 26 44 22 24 46 72 101 171 90 94 184 Biosimilars Renflexis 63 14 77 51 9 60 234 43 278 196 30 226 Ontruzant 10 52 62 13 22 35 46 109 155 48 74 122 Brenzys — 28 28 — 23 23 — 73 73 — 75 75 Aybintio — 9 9 — 10 10 — 43 43 — 39 39 Hadlima 15 8 23 — 6 6 17 26 44 — 19 19 Established Brands Cardiovascular Zetia 3 65 67 1 70 71 8 299 306 8 350 357 Vytorin 1 28 29 1 25 26 6 124 129 8 123 130 Atozet — 122 122 — 107 107 — 519 519 — 457 457 Rosuzet — 18 18 — 16 16 — 70 70 — 71 71 Cozaar/Hyzaar 2 55 57 2 66 68 10 272 281 13 310 323 Other Cardiovascular (1) — 28 29 1 39 40 2 151 155 3 156 159 Respiratory Singulair 2 111 114 3 92 95 11 393 404 11 400 411 Nasonex — 65 65 — 56 56 — 252 253 10 229 238 Dulera 40 10 50 42 10 52 156 38 194 140 40 180 Clarinex 1 29 30 2 25 27 5 132 136 4 121 125 Other Respiratory (1) 8 8 15 12 5 17 49 28 77 46 36 83 Non-Opioid Pain, Bone and Arcoxia — 51 51 — 56 56 — 257 257 — 241 241 Fosamax — 35 36 2 34 36 3 156 159 4 148 152 Diprospan — 33 33 — 31 31 — 91 91 — 122 122 Other Non-Opioid Pain, Bone and Dermatology (1) 4 64 67 5 56 62 14 261 275 15 257 273 Other Proscar — 20 20 — 23 24 1 96 97 1 99 101 Propecia 2 31 33 2 28 30 7 118 125 7 118 125 Other (1) 1 78 79 3 72 75 13 308 319 24 302 326 Other (2) 1 18 19 (1 ) 30 30 (1 ) 121 121 — 146 146 Revenues $ 411 $ 1,187 $ 1,598 $ 394 $ 1,091 $ 1,485 $ 1,478 $ 4,785 $ 6,263 $ 1,437 $ 4,737 $ 6,174 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 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. TABLE 3 Organon & Co. Sales by geographic area (Unaudited, $ in millions) Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 Europe and Canada $ 414 $ 389 $ 1,673 $ 1,631 United States 411 394 1,478 1,437 Asia Pacific and Japan 261 256 1,129 1,143 China 203 196 864 917 Latin America, Middle East, Russia, and Africa 279 230 965 895 Other (1) 30 20 154 151 Revenues $ 1,598 $ 1,485 $ 6,263 $ 6,174 (1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties. TABLE 4 Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited, $ in millions except per share amounts) Three Months Ended December 31, 2023 GAAP Spin related Costs(1) Restructuring Stock-based Compensation Amortization Other(2) Non-GAAP Adjusted Revenues $ 1,598 $ 1,598 Cost of sales 683 (17 ) — (4 ) (28 ) — 634 Gross profit 915 964 Gross margin 57.3 % 60.3 % Selling, general and administrative 469 (47 ) — (18 ) — (3 ) 401 Research and development 134 (2 ) — (5 ) — — 127 Acquired in-process research and development and milestones — — — — — — — Restructuring costs 58 — (58 ) — — — — Interest expense 129 — — — — — 129 Exchange losses 17 — — — — — 17 Other expense (income), net 4 (4 ) — — — — — 1,494 1,308 Income before income taxes 104 290 Taxes on income (442 ) 7 12 5 5 477 64 Net income $ 546 $ 226 Earnings per share - Diluted $ 2.13 $ 0.88 (1) One-time spin-related costs includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US. (2) Other costs primarily includes a tax benefit resulting from the termination of a Swiss tax arrangement and one-time costs related to inventory step-up adjustments and legal reserves. Three Months Ended December 31, 2022 GAAP Spin related Costs(1) Restructuring Stock-based Compensation Amortization Other(2) Non-GAAP Adjusted Revenues $ 1,485 $ 1,485 Cost of sales 594 (7 ) — (4 ) (28 ) (7 ) 548 Gross profit 891 937 Gross margin 60.0 % 63.1 % Selling, general and administrative 470 (36 ) — (16 ) — (4 ) 414 Research and development 142 (3 ) — (3 ) — (1 ) 135 Acquired in-process research and development and milestones — — — — — — — Restructuring costs 17 — (17 ) — — — — Interest expense 119 — — — — — 119 Exchange losses 32 — — — — — 32 Other expense (income), net — (3 ) — — — 3 — 1,374 1,248 Income before income taxes 111 237 Taxes on income 3 12 4 6 4 — 29 Net income $ 108 $ 208 Earnings per share - Diluted $ 0.42 $ 0.81 (1) One-time spin-related costs includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US. (2) Other costs primarily includes one-time costs related to inventory step-up adjustments and legal reserves. TABLE 4 (continued) Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited, $ in millions except per share amounts) Year Ended December 31, 2023 GAAP Spin related Costs(1) Restructuring Stock-based Compensation Amortization Other(2) Non-GAAP Adjusted Revenues $ 6,263 $ 6,263 Cost of sales 2,515 (47 ) — (17 ) (116 ) (2 ) 2,333 Gross profit 3,748 3,930 Gross margin 59.8 % 62.7 % Selling, general and administrative 1,893 (178 ) — (68 ) — (91 ) 1,556 Research and development 528 (12 ) — (16 ) — — 500 Acquired in-process research and development and milestones 8 — — — — — 8 Restructuring costs 62 — (62 ) — — — — Interest expense 527 — — — — — 527 Exchange losses 42 — — — — — 42 Other expense (income), net 15 (17 ) — — — — (2 ) 5,590 4,964 Income before income taxes 673 1,299 Taxes on income (350 ) 49 13 17 21 488 238 Net income $ 1,023 $ 1,061 Earnings per share - Diluted $ 3.99 $ 4.14 (1) One-time spin-related costs includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US. (2) Other costs primarily includes a tax benefit resulting from the termination of a Swiss tax arrangement and one-time costs related to inventory step-up adjustments and legal reserves. Year Ended December 31, 2022 GAAP Spin related Costs(1) Restructuring Stock-based Compensation Amortization Other(2) Non-GAAP Adjusted Revenues $ 6,174 $ 6,174 Cost of sales 2,294 (25 ) — (13 ) (116 ) (24 ) 2,116 Gross profit 3,880 4,058 Gross margin 62.8 % 65.7 % Selling, general and administrative 1,704 (122 ) — (51 ) — (21 ) 1,510 Research and development 471 (11 ) — (11 ) — (3 ) 446 Acquired in-process research and development and milestones 107 — — — — — 107 Restructuring costs 28 — (28 ) — — — — Interest expense 422 — — — — — 422 Exchange losses 11 — — — — — 11 Other expense (income), net 15 (23 ) — — — 3 (5 ) 5,052 4,607 Income before income taxes 1,122 1,567 Taxes on income 205 36 6 13 19 4 283 Net income $ 917 $ 1,284 Earnings per share - Diluted $ 3.59 $ 5.03 (1) One-time spin-related costs includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US. (2) Other costs primarily includes one-time costs related to inventory step-up adjustments, impairment charges and legal reserves. TABLE 5 Organon & Co. Reconciliation of GAAP Income Before Income Taxes to Adjusted EBITDA (Unaudited, $ in millions) Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 Income before income taxes $ 104 $ 111 $ 673 $ 1,122 Depreciation (1) 30 24 118 96 Amortization 28 28 116 116 Interest expense 129 119 527 422 EBITDA $ 291 $ 282 $ 1,434 $ 1,756 Restructuring costs 58 17 62 28 One-time costs (2) 73 58 347 226 Stock-based compensation 27 23 101 75 Adjusted EBITDA $ 449 $ 380 $ 1,944 $ 2,085 Adjusted EBITDA margin 28.1 % 25.6 % 31.0 % 33.8 % (1) Excludes accelerated depreciation included in one-time costs. (2) One-time costs primarily include costs incurred in connection with the spin-off of Organon, inventory step-up adjustments, impairment charges and legal reserves. View source version on businesswire.com: Contacts Media Contacts: Karissa Peer (614) 314-8094 Kate Vossen (732) 675-8448 Investor Contacts: Jennifer Halchak (201) 275-2711 Alex Arzeno (203) 550-3972 Source: Organon & Co. View this news release online at: