Wall Street analysts forecast that Organon (OGN) will report quarterly earnings of $0.97 per share in its upcoming release, pointing to a year-over-year decline of 10.2%. It is anticipated that revenues will amount to $1.57 billion, exhibiting an increase of 2% compared to the year-ago quarter.The current level reflects no revision in the consensus EPS estimate for the quarter over the past 30 days. This demonstrates how the analysts covering the stock have collectively reappraised their initial projections ...

Wall Street expects a year-over-year decline in earnings on higher revenues when Organon (OGN) reports results for the quarter ended March 2024. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on May 2. On the other ...

Environmental Liabilities and Expenditures - Environmental remediation and liability expenditures estimated at $15 million for 2024-2028[95] - Environmental liabilities totaled $19 million at December 31, 2023, and $20 million at December 31, 2022, with payments expected over the next 15 years[540] Biosimilars and Licensing Agreements - Exclusive license to commercialize biosimilars including adalimumab, bevacizumab, infliximab, trastuzumab, and etanercept under the Samsung Bioepis Agreement[96] - Gross profits shared equally in most markets, except Brazil where Samsung Bioepis receives 65% and the company receives 35%[100] - $25 million in potential future regulatory milestone payments remaining under the Samsung Bioepis Agreement as of December 31, 2023[100] - Worldwide commercialization rights for biosimilar candidates HLX11 and HLX14 secured through an exclusive license agreement with Henlius[101] - Organon licensed commercialization rights for biosimilar candidates HLX11 and HLX14 from Henlius, paying $73 million upfront and potentially up to $468 million in milestone payments[409] Financial Performance and Tax - $863 million of net deferred tax assets as of December 31, 2023, including $309 million in valuation allowances[324] - $476 million tax benefit recorded in 2023 due to the termination of a tax arrangement in Switzerland[324] - Revenues for 2023 were $6,263 million, a slight increase from $6,174 million in 2022[334] - Net income for 2023 was $1,023 million, up from $917 million in 2022[334] - Comprehensive income for 2023 was $1,046 million, compared to $866 million in 2022[337] - Net income from continuing operations for 2023 was $1,023 million, compared to $917 million in 2022 and $1,351 million in 2021[346] - Net income for 2023 was $1,023 million, with basic EPS of $4.01 and diluted EPS of $3.99[415] Research and Development - Research and development expenses increased to $528 million in 2023 from $471 million in 2022[334] - The company made a strategic investment in Claria Medical, Inc., paying $8 million upfront with an option to acquire for an additional $47 million, recognized as acquired in-process R&D[406] - Organon entered into a research collaboration with Cirqle Biomedical, paying $10 million upfront and potentially up to $360 million in milestone payments, with tiered royalties based on net sales[407][408] Assets and Liabilities - Total assets grew to $12,058 million in 2023 from $10,955 million in 2022[340] - Long-term debt decreased to $8,751 million in 2023 from $8,905 million in 2022[340] - Cash and cash equivalents decreased to $693 million in 2023 from $706 million in 2022[340] - Accounts receivable increased to $1,744 million in 2023 from $1,475 million in 2022[340] - Inventories rose to $1,315 million in 2023 from $1,003 million in 2022[340] - Total stockholders' deficit improved to $70 million in 2023 from $892 million in 2022[340] Operating Activities and Capital Expenditures - Net cash flows provided by operating activities from continuing operations were $799 million in 2023, down from $858 million in 2022 and $2,160 million in 2021[346] - Capital expenditures in 2023 were $251 million, up from $196 million in 2022 and $192 million in 2021[346] - Dividend payments in 2023 totaled $294 million, compared to $290 million in 2022 and $145 million in 2021[346] Product Portfolio and Market Launches - Organon's women's health portfolio includes Nexplanon, NuvaRing, and Follistim AQ, with Xaciato launched in the US in October 2023[351] - Organon's biosimilars portfolio includes Ontruzant, Aybintio, Brenzys, Renflexis, and Hadlima, with launches in over 20 countries for some products[351] - Organon operates six manufacturing facilities located in Belgium, Brazil, Indonesia, Mexico, the Netherlands, and the United Kingdom[348] - The company has a portfolio of more than 60 medicines and products across women's health, biosimilars, and established brands[348] - Organon's product portfolios include women's health, biosimilars, and established brands, constituting one operating segment[418] Separation from Merck and Standalone Operations - Organon became a standalone publicly traded company on June 2, 2021, following its separation from Merck[349] - The company's historical financial results prior to the separation were derived from Merck's consolidated financial statements and accounting records[349] - Net investment from Merck & Co., Inc. was reclassified to Common Stock and Accumulated Deficit as part of the Separation[360] - The Company incurred certain costs in its establishment as a standalone public company and expects to incur ongoing additional costs associated with operating as an independent, publicly traded company[362] - The Company adjusted its deferred tax balances and computed its related tax provision to reflect operations as a standalone entity as of June 2, 2021[363] - The Company's participation in the defined pension and postretirement benefit plans sponsored by Merck concluded upon the completion of the Separation on June 2, 2021[388] Rebates, Discounts, and Accruals - $417 million accrued for U.S. rebate accruals related to Medicaid and Managed Care as of December 31, 2023[327] - The Company's provision for aggregate customer discounts was $2,640 million in 2023, $2,221 million in 2022, and $2,000 million in 2021[371] - The accrued balances relative to the provisions for chargebacks and rebates in the United States were $87 million and $417 million, respectively, at December 31, 2023[371] - The accrued balances related to the provision for rebates and discounts outside the United States were approximately $126 million and $109 million at December 31, 2023 and 2022, respectively[372] Depreciation and Advertising Expenses - Depreciation expense was $120 million in 2023, $96 million in 2022, and $92 million in 2021[378] - Advertising and promotion expenses were $209 million, $255 million, and $236 million in 2023, 2022, and 2021, respectively[379] Goodwill and Lease Expenses - The Company completed the annual qualitative goodwill impairment test as of October 1, 2023 and concluded that there was no impairment to goodwill[380] - Operating lease expenses are recognized on a straight-line basis, with assets and liabilities calculated using the incremental borrowing rate, updated quarterly based on the weighted average remaining lease term and pretax cost of debt[397] Strategic Investments and Acquisitions - Organon paid an upfront payment of $50 million to Lilly for the distribution rights of Emgality® and Rayvow™ in Europe, with additional sales-based milestone payments[541] - The upfront payment and certain sales-based milestone payments are recognized as an intangible asset in Q1 2024[541] - Organon licensed global commercial rights to Xaciato from Daré Bioscience, paying $10 million upfront and potentially up to $182.5 million in milestone payments, with tiered double-digit royalties[411] - Organon acquired product rights and inventory for Marvelon™ and Mercilon™ in China and Vietnam from Bayer Healthcare, paying $95 million and recognizing $72 million as intangible assets[412][413] Share Information - The company has 255,239 thousand basic weighted average shares outstanding and 256,270 thousand diluted weighted average shares outstanding for 2023[415]

Organon Fourth Quarter and Full Year 2023 Earnings 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 full-year 2024 guidance estimates and predictions regarding ot ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________ Form 10-Q ________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission File No. 001-40235 Organon & Co. (Exact name of registrant as specifi ...

Financial Data and Key Metrics Changes - Total revenue decreased by 1% at constant currency compared to the prior year, with product sales growing 1% at constant currency for the eighth consecutive quarter [4][13] - Adjusted EBITDA margin was 29.4% in Q3 2023, down from 35.5% in the same period last year, with adjusted net income of $223 million or $0.87 per diluted share compared to $337 million or $1.32 per diluted share in 2022 [29][66] - Free cash flow for 2023 is expected to be between $700 million to $800 million, about $250 million below earlier expectations due to lower EBITDA and working capital use [30][106] Business Line Data and Key Metrics Changes - Women's Health revenue declined by 7% at constant currency, primarily due to NuvaRing facing generic competition, while the fertility business is expected to show high single-digit growth for the full year [14][15] - Nexplanon experienced a 3% decline ex-FX in Q3 but is projected to achieve low single-digit growth for the full year, with expectations of reaching a $1 billion run rate by 2025 [15][39] - Biosimilars grew by 10% ex-FX in Q3 and 15% year-to-date, with Renflexis on track for its sixth consecutive year of annual revenue growth in the U.S. [26][49] Market Data and Key Metrics Changes - In China, the fertility business has grown by 15% year-to-date at constant currency, with expectations for continued growth despite recent economic challenges [5][20] - The Chinese healthcare budget is currently in a deficit, impacting procurement processes, but the company has managed to maintain a diverse portfolio with no single product representing more than 16% of revenue [20][72] - The U.S. fertility market is growing, with a significant increase in employers providing fertility benefits, which is expected to drive future growth [46][97] Company Strategy and Development Direction - The company is adapting its U.S. go-to-market model for Nexplanon to align pricing with health plans' reimbursement schedules, which is expected to smooth revenue fluctuations [6][92] - There is a focus on expanding the supply capacity for Nexplanon to meet strong international demand, particularly in Asia and Africa [16][93] - The company aims to reduce leverage and maximize the existing portfolio's potential while exploring opportunities for growth through acquisitions [52][106] Management's Comments on Operating Environment and Future Outlook - Management acknowledged external factors such as a strong U.S. dollar and a challenging economic environment in China, but remains optimistic about product sales growth [13][66] - The company expects to see a return to normal engagement levels in China by early next year, with growth anticipated in the fourth quarter [20][97] - Management believes that the transient headwinds faced in 2023 will serve as tailwinds for growth in 2024, projecting mid-single-digit revenue growth over the medium term [52][66] Other Important Information - The company reached a settlement agreement regarding patent infringement claims for Nexplanon, reserving $80 million to cover the settlement over three years [28] - The impact of volume-based procurement (VBP) in China is expected to be lower than previously guided, with improved management of price erosion across several markets [32][58] - The company is implementing a new global ERP system, which has temporarily tied up cash but is expected to improve cash flow in the future [62][106] Q&A Session Summary Question: Clarification on Nexplanon's go-to-market model and biosimilar competition - Management explained that the change in Nexplanon's go-to-market model aims to smooth revenue fluctuations and align with reimbursement schedules, while biosimilar competition has not intensified significantly [68][91] Question: Impact of VBP on China business going into 2024 - Management indicated that approximately 75% of the Established Brands business will have gone through VBP by the end of the year, with a focus on retail sector growth [71][72] Question: Role of biosimilars and potential monetization - Management views biosimilars as an opportunistic segment with potential for growth, emphasizing the strong market position of Hadlima despite slower-than-expected uptake [73][75] Question: Free cash flow outlook and working capital impact - Management expects working capital issues to be temporary, with a return to higher free cash flow generation anticipated next year [78][106] Question: FDA recommendations on biosimilar labeling - Management believes the FDA's draft statement on biosimilar labeling could act as a tailwind for Hadlima's uptake, facilitating easier patient switches at pharmacies [82][84]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________ Form 10-Q ________________ (Mark One) | | | For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission File No. 001-40235 Organon & Co. (Exact name of registrant as specified in its charter) Delaware 46-4838035 (State or other jurisdiction of incorporation) (I. ...

Organon & Co (NYSE:OGN) Q2 2023 Earnings Conference Call August 8, 2023 8:30 AM ET Company Participants Jennifer Halchak - VP, IR Kevin Ali - CEO Matthew Walsh - CFO Sandra Milligan - Head of R&D Conference Call Participants David Amsellem - Piper Sandler Umer Raffat - Evercore Jason Gerberry - Bank of America Navann Ty - BNP Paribas Exxon Chris Shibutani - Goldman Sachs Operator Ladies and gentlemen, thank you for standing by. At this time, I would like to welcome everyone to the Organon Second Quarter 202 ...

Organon Second Quarter 2023 Earnings GANON™ Cautionary Note Regarding Forward-Looking Statements Disclaimer statement, cont. See Slides 21-26 of this presentation for a reconciliation of non-GAAP measures. • Adjusted EBITDA of $530 million • Adjusted EBITDA margin guidance range raised to 31.5%-33.0% Disclaimer statement 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; ch ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________ Form 10-Q ________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission File No. 001-40235 Organon & Co. (Exact name of registrant as specified in its charter) Del ...