Core Insights - Organon reported $1.59 billion in revenue for Q2 2025, reflecting a year-over-year decline of 0.8% and an EPS of $1.00, down from $1.12 a year ago [1] - The revenue exceeded the Zacks Consensus Estimate of $1.55 billion by 2.63%, while the EPS surpassed the consensus estimate of $0.94 by 6.38% [1] Revenue Performance by Segment - Established Brands in the U.S. for Respiratory (Singulair) generated $2 million, slightly above the $1.95 million estimate, with no year-over-year change [4] - Women's Health International for Nexplanon/Implanon NXT achieved $77 million, exceeding the $75.7 million estimate, marking a 10% increase year-over-year [4] - Women's Health U.S. for NuvaRing reported $7 million, matching estimates but showing a 30% decline year-over-year [4] - Women's Health International for Follistim AQ reached $43 million, surpassing the $41.53 million estimate, reflecting a 7.5% increase year-over-year [4] - Women's Health for Nexplanon/Implanon NXT totaled $240 million, below the $258.98 million estimate, with a slight decline of 0.8% year-over-year [4] - Women's Health for Follistim AQ generated $74 million, exceeding the $69.57 million estimate, showing a 19.4% increase year-over-year [4] - Total revenue for Established Brands was $936 million, above the $905.64 million estimate, but down 2.8% year-over-year [4] - Biosimilars total revenue reached $173 million, exceeding the $153.98 million estimate, with a year-over-year increase of 5.5% [4] - Total revenue for Women's Health was $462 million, slightly below the $471.79 million estimate, with a year-over-year increase of 2.9% [4] - Other revenue totaled $23 million, above the $21.74 million estimate, but down 25.8% year-over-year [4] - Women's Health for NuvaRing reported $28 million, exceeding the $22.99 million estimate, with a 3.5% decline year-over-year [4] - Biosimilars for Renflexis generated $63 million, surpassing the $56.8 million estimate, but reflecting an 8.7% decline year-over-year [4] Stock Performance - Organon's shares returned -0.5% over the past month, compared to a +1% change in the Zacks S&P 500 composite [3] - The stock currently holds a Zacks Rank 2 (Buy), indicating potential for outperformance in the near term [3]

Organon (OGN) came out with quarterly earnings of $1 per share, beating the Zacks Consensus Estimate of $0.94 per share. This compares to earnings of $1.12 per share a year ago. These figures are adjusted for non- recurring items. This quarterly report represents an earnings surprise of +6.38%. A quarter ago, it was expected that this pharmaceutical company would post earnings of $0.89 per share when it actually produced earnings of $1.02, delivering a surprise of +14.61%. Ahead of this earnings release, th ...

Financial Data and Key Metrics Changes - Revenue for the second quarter was $1.6 billion, down 1% at constant currency, primarily due to the loss of exclusivity of Adazet in the EU [6][21] - Adjusted EBITDA for the quarter was $522 million, representing a 32.7% margin, with year-to-date adjusted EBITDA at $1 billion or a 32.4% margin [6][7] - The company is raising its revenue guidance range by $100 million at the midpoint due to favorable operational performance [6][34] Business Line Data and Key Metrics Changes - Women's health franchise grew 2% at constant currency, with the fertility business growing 15% driven by increased demand [9][10] - Sales of Nexplanon declined 1% at constant currency in the second quarter, with a 5% decline in the U.S. but a 10% growth outside the U.S. [11][12] - Biosimilars, particularly HEDLEMA, performed better than expected, generating nearly $100 million, up 68% year-over-year [14][15] Market Data and Key Metrics Changes - The U.S. market for Nexplanon is facing funding constraints from federal and state programs, impacting purchasing decisions [12][51] - Pricing pressure was noted primarily from the loss of exclusivity of Adazet and certain mature products in the U.S. [22] - Volume increased by $90 million in the quarter, representing a growth of about 5.6% [23] Company Strategy and Development Direction - The company is focused on reducing its debt burden, having repaid approximately $350 million of principal on long-term debt instruments [8][9] - A strong emphasis on EBITDA generation is aimed at delivering over $900 million of free cash flow before one-time costs in 2025 [7][8] - The company is committed to building Nexplanon into a billion-dollar franchise, reflecting confidence in its long-term growth potential [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue growth despite challenges from the loss of exclusivity of Adazet [19][40] - The company anticipates continued global growth for Nexplanon, with a five-year indication submission to the FDA expected to enhance market potential [13][54] - Management highlighted the importance of VITAMMA as a growth catalyst and expects significant progress in access objectives [20][19] Other Important Information - The adjusted gross margin for the second quarter was 61.7%, slightly down from 62% in 2024, primarily due to pricing pressures [25] - The company expects total operating expenses to be generally flat with the prior year, aiming for $200 million of operational savings in 2025 [26][30] - The company is on track to achieve a net leverage ratio below four times by year-end 2025 [9][41] Q&A Session Summary Question: Can you talk about incremental sales and marketing investment for VITAMMA? - Management confirmed the start of new telehealth and DTC campaigns and an increase in sales force to support VITAMMA [44][45] Question: Can you elaborate on the federal funding headwinds for Nexplanon? - Management indicated that the decline in U.S. Nexplanon sales was due to a combination of purchase timing and underlying market pressures, but expressed confidence in growth moving forward [50][54] Question: What impact might tariffs have on margins in 2026? - Management stated it is too early to speculate on tariff impacts for 2026, but noted that the EU is the largest import exposure for the company [58] Question: How should we think about free cash flow conversion and one-time items? - Management expects free cash flow to grow in line with the business, with a continued reduction in one-time costs [61] Question: What is the status of the 6219 endometriosis program? - Management confirmed the discontinuation of the program due to lack of efficacy signals [86] Question: Will the FDA update the real-time release study for Nexplanon? - Management is working closely with the FDA for appropriate labeling for the five-year indication but did not comment on specific FDA decisions [87]

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $1.6 billion, down 1% at constant currency, primarily due to the loss of exclusivity of Adazet in the EU [5][20] - Adjusted EBITDA for the quarter was $522 million, representing a 32.7% margin, with year-to-date adjusted EBITDA at $1 billion or 32.4% margin [5][6] - The company is raising its revenue guidance by $100 million at the midpoint for the full year based on year-to-date performance and foreign currency movements [5][33] Business Line Data and Key Metrics Changes - Women's health franchise grew 2% at constant currency, with the fertility business growing 15% in Q2 2025 [7][8] - Sales of Nexplanon declined 1% at constant currency in Q2, with a 5% decline in the U.S. but a 10% growth outside the U.S. [10][11] - Biosimilars, particularly HEDLEMA, performed better than expected, generating nearly $100 million, up 68% year-over-year [12][13] Market Data and Key Metrics Changes - The U.S. market for Nexplanon is facing funding constraints from federal and state programs, impacting purchasing decisions [10][11] - Pricing pressure was noted primarily from the loss of exclusivity of Adazet and certain mature products in the U.S. [21][22] - Volume increased by $90 million in Q2, representing a growth of about 5.6%, driven by fertility, HEDLEMA, Emgality, and VITAMMA [22] Company Strategy and Development Direction - The company is focused on reducing its debt burden, having repaid approximately $350 million of long-term debt in Q2 [6][31] - Aiming for a net leverage ratio below four times by year-end and further improvements to 3.5 times or below by 2026 [6][31] - The company is committed to building Nexplanon into a billion-dollar franchise and expanding its market presence [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving free cash flow of over $900 million before one-time costs in 2025 [6][41] - The company is optimistic about the growth potential of VITAMMA and expects to achieve significant access improvements by early 2026 [15][18] - Management acknowledged challenges in the U.S. market due to federal funding issues but remains confident in Nexplanon's long-term growth potential [11][53] Other Important Information - The company expects to see a modest decline in adjusted gross margin in the second half of the year but aims to land closer to the high end of the 60% to 61% range [36][39] - One-time costs related to restructuring are expected to decline, improving free cash flow conversion in the coming years [60][61] Q&A Session Summary Question: Can you talk about incremental sales and marketing investment for VITAMMA? - The company has started new telehealth and DTC campaigns and added more sales representatives, totaling over 125 in the field [44][45] Question: Can you elaborate on the federal funding headwinds for Nexplanon? - The decline in U.S. Nexplanon sales is attributed to both purchase timing and underlying pressures, with confidence in growth despite market confusion [48][52] Question: What is the expected impact of tariffs on margins in 2026? - It is too early to speculate on tariff impacts for 2026, but the EU is the largest import exposure for the company [56][57] Question: How should we think about free cash flow conversion and one-time items? - Free cash flow should grow in line with the business, with a continued reduction in one-time costs expected [60][61] Question: What is the status of the 6219 endometriosis program? - The company has decided to discontinue the program due to lack of efficacy signals [80][82] Question: Will the FDA update the guidance for generics regarding Nexplanon? - The company is working closely with the FDA for the new labeling for the five-year indication, but the FDA will make its own assessment [82][86]

Financial Performance - Revenue was $1.6 billion, down 1% ex-FX, consistent with the phasing of the Loss of Exclusivity (LOE) of Atozet[12] - Adjusted EBITDA was $522 million, representing a 32.7% Adjusted EBITDA margin[12] - The company raised full-year 2025 revenue guidance by $100 million at the midpoint, while the Adjusted EBITDA range was affirmed[12] - The company repaid $345 million of long-term debt and is on track to achieve net leverage below 40x by year-end[12] - Adjusted Gross Margin was 617% for both Q2 2025 and YTD 2025, compared to 620% for Q2 2024 and YTD 2024[30] Segment Performance - Women's Health revenue increased by 3% to $462 million in Q2 2025, and 6% YTD to $925 million[14] - Biosimilars revenue increased by 5% to $173 million in Q2 2025, but decreased 6% YTD to $314 million[18] - Established Brands revenue decreased by 3% to $936 million in Q2 2025, and 7% YTD to $1822 billion[23] Product Performance - Nexplanon revenue decreased 1% to $240 million in Q2 2025, but increased 6% YTD to $488 million[14] - Follistim AQ revenue increased 18% to $74 million in Q2 2025, and 31% YTD to $142 million[14] - Hadlima revenue increased 78% to $50 million in Q2 2025, and 66% YTD to $96 million[18]

[Financial Highlights](index=1&type=section&id=Financial%20Highlights) Organon reported Q2 2025 revenue of $1.594 billion and $1.00 non-GAAP Adjusted diluted EPS, repaid $345 million debt, and raised full-year revenue guidance | Metric | Q2 2025 | | :--- | :--- | | Revenue | $1.594 billion | | GAAP Diluted EPS | $0.56 | | Non-GAAP Adjusted Diluted EPS | $1.00 | | Net Income | $145 million | | Adjusted EBITDA (Non-GAAP) | $522 million | | Adjusted EBITDA Margin (Non-GAAP) | 32.7% | - The company repaid **$345 million** of long-term debt during the quarter and is on track to achieve a net debt to Adjusted EBITDA ratio of less than **4.0x** by the end of 2025, with a further goal of **3.5x** or below by the end of 2026[3](index=3&type=chunk)[4](index=4&type=chunk) - Full-year 2025 revenue guidance was raised to a range of **$6.275 billion** to **$6.375 billion**, primarily based on updated views of foreign exchange rates[4](index=4&type=chunk) [Financial Performance Analysis](index=2&type=section&id=Financial%20Performance%20Analysis) Q2 2025 revenue decreased 1% to $1.594 billion, with growth in Women's Health and Biosimilars offset by Established Brands, while Adjusted EBITDA margin improved to 32.7% [Revenue Analysis](index=2&type=section&id=Revenue%20Analysis) Q2 2025 revenue totaled $1.594 billion, down 1% YoY, with Women's Health and Biosimilars growth offset by Established Brands decline due to loss of exclusivity | Segment | Q2 2025 Revenue ($M) | YoY Change | YoY Change (ex-FX) | | :--- | :--- | :--- | :--- | | Women's Health | $462 | 3% | 2% | | Biosimilars | $173 | 5% | 6% | | Established Brands | $936 | (3)% | (4)% | | **Total Revenue** | **$1,594** | **(1)%** | **(1)%** | - Women's Health growth was driven by the fertility business (**+15% ex-FX**), while Nexplanon® sales declined **1% ex-FX** due to constrained funding for subsidized programs in the U.S[7](index=7&type=chunk) - Biosimilars growth was primarily due to strong performance of Hadlima®, which more than offset expected declines in mature products like Ontruzant® and Renflexis®[8](index=8&type=chunk) - Established Brands revenue declined due to the loss of exclusivity of Atozet™ in key European markets and lower sales of Singulair® in China and Japan[9](index=9&type=chunk) [Profitability Analysis](index=3&type=section&id=Profitability%20Analysis) GAAP net income fell 26% to $145 million, while non-GAAP Adjusted EBITDA increased 2% to $522 million, with margin improving to 32.7% due to reduced operating expenses | Metric | Q2 2025 | Q2 2024 | YoY Change | | :--- | :--- | :--- | :--- | | Net Income | $145M | $195M | (26)% | | Diluted EPS | $0.56 | $0.75 | (25)% | | Non-GAAP Adjusted Net Income | $261M | $289M | (10)% | | Non-GAAP Adjusted Diluted EPS | $1.00 | $1.12 | (11)% | | Adjusted EBITDA (Non-GAAP) | $522M | $513M | 2% | | Adjusted EBITDA Margin (Non-GAAP) | 32.7% | 31.9% | +0.8 p.p. | - The year-over-year improvement in Adjusted EBITDA margin was primarily driven by a **3% reduction in operating expenses**[14](index=14&type=chunk) - Lower reported GAAP gross margin was due to higher amortization expense related to prior-year acquisitions and the Dermavant acquisition. Non-GAAP Adjusted gross margin was consistent with the prior year[12](index=12&type=chunk) [Capital Allocation and Financial Position](index=4&type=section&id=Capital%20Allocation%20and%20Financial%20Position) Organon declared a $0.02 per share dividend, repaid **$345 million** in debt, and held **$599 million** cash against **$8.90 billion** debt as of June 30, 2025 - The Board of Directors declared a quarterly dividend of **$0.02 per share**, payable on September 11, 2025[15](index=15&type=chunk) - The company made principal repayments on long-term debt totaling **$345 million** in Q2 2025. This included repurchasing **$242 million** of its 2031 Notes, resulting in a pre-tax gain of **$42 million**[16](index=16&type=chunk) Financial Position (as of June 30, 2025) | Financial Position (as of June 30, 2025) | Amount ($M) | | :--- | :--- | | Cash and cash equivalents | $599 | | Debt | $8,900 | [Full Year 2025 Guidance](index=5&type=section&id=Full%20Year%202025%20Guidance) Organon raised full-year 2025 revenue guidance to **$6.275 billion** - **$6.375 billion** due to reduced foreign exchange headwind, while other non-GAAP metrics remain unchanged Full Year 2025 Guidance Summary | Guidance Metric | Previous Guidance (May 1, 2025) | Current Guidance | | :--- | :--- | :--- | | Revenue | $6.125B - $6.325B | $6.275B - $6.375B | | FX Translation Headwind | ~$200M | ~$50M | | Adjusted EBITDA Margin (Non-GAAP) | 31.0% - 32.0% | Unchanged | - The increase in revenue guidance is attributed to a more favorable foreign exchange outlook, with the expected headwind reduced from **~$200 million** to **~$50 million**[19](index=19&type=chunk) - Guidance for Adjusted Gross Margin, SG&A, R&D, Adjusted EBITDA Margin, Interest, Depreciation, tax rate, and share count remains unchanged[19](index=19&type=chunk) [Appendix: Financial Statements and Reconciliations](index=9&type=section&id=Appendix%3A%20Financial%20Statements%20and%20Reconciliations) This appendix provides detailed unaudited financial statements, including consolidated income, sales breakdowns, and GAAP to non-GAAP reconciliations [Consolidated Statement of Income](index=9&type=section&id=Consolidated%20Statement%20of%20Income) The consolidated statement of income presents key financial results for Q2 and first six months of 2025 versus 2024, including revenues and net income Consolidated Statement of Income (Three Months Ended June 30) | ($ in millions) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenues | $1,594 | $1,607 | | Gross Profit | $874 | $939 | | Income before income taxes | $229 | $235 | | Net income | $145 | $195 | | Diluted EPS | $0.56 | $0.75 | [Sales by Product and Geography](index=10&type=section&id=Sales%20by%20Product%20and%20Geography) This section details Q2 2025 sales revenue by product, including top sellers like Nexplanon, and by geographic region, with Europe and Canada as the largest Top Products (Q2 2025) | Top Products (Q2 2025) | Total Sales ($M) | | :--- | :--- | | Nexplanon/Implanon NXT | $240 | | Atozet | $86 | | Follistim AQ | $74 | | Zetia | $74 | | Singulair | $66 | Geography (Q2 2025) | Geography (Q2 2025) | Total Sales ($M) | YoY Change | | :--- | :--- | :--- | | Europe and Canada | $419 | (8.3)% | | United States | $414 | 6.7% | | Asia Pacific and Japan | $250 | (3.8)% | | China | $204 | (5.6)% | [Reconciliation of GAAP to Non-GAAP Measures](index=12&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Measures) This section provides detailed reconciliations of GAAP to non-GAAP financial metrics, including Adjusted EBITDA and Adjusted Net Income for Q2 2025 Reconciliation to Adjusted EBITDA (Q2 2025) | Reconciliation to Adjusted EBITDA (Q2 2025, $M) | Amount | | :--- | :--- | | **GAAP Reported Net Income** | **$145** | | Depreciation | $33 | | Amortization | $53 | | Interest expense | $131 | | Income tax expense | $84 | | Restructuring and related charges | $6 | | Manufacturing network related | $36 | | Stock-based compensation | $22 | | Other adjustments | $14 | | **Adjusted EBITDA (Non-GAAP)** | **$522** | Reconciliation to Adjusted Net Income (Q2 2025) | Reconciliation to Adjusted Net Income (Q2 2025, $M) | Amount | | :--- | :--- | | **GAAP Reported Net Income** | **$145** | | Cost of sales adjustments | $109 | | SG&A adjustments | $44 | | R&D adjustments | $7 | | Other adjustments | $(31) | | Tax impact on adjustments | $(13) | | **Non-GAAP Adjusted Net Income** | **$261** |

Core Insights - Analysts project Organon (OGN) will report quarterly earnings of $0.94 per share, a decline of 16.1% year over year, with revenues expected to reach $1.55 billion, down 3.4% from the same quarter last year [1] Revenue Projections - Revenue from Women's Health for Nexplanon/Implanon NXT is estimated at $258.98 million, reflecting a year-over-year increase of +7% [4] - Revenue from Women's Health for Follistim AQ is projected to be $69.57 million, indicating a year-over-year increase of +12.2% [4] - Total revenue from Established Brands is expected to be $905.64 million, showing a decline of -6% from the prior-year quarter [4] - Revenue from Biosimilars Total is anticipated to be $153.98 million, representing a decrease of -6.1% from the year-ago quarter [5] - Revenue from Women's Health in the U.S. for Nexplanon/Implanon NXT is estimated at $183.28 million, indicating a year-over-year increase of +7.2% [5] - Geographic Revenue from the U.S. is projected to be $437.92 million, reflecting a year-over-year increase of +12.9% [5] - Revenue from Women's Health in the U.S. for NuvaRing is expected to be $7.00 million, suggesting a decline of -30% year over year [6] - Revenue from Women's Health in the U.S. for Follistim AQ is projected to reach $28.03 million, indicating a year-over-year increase of +27.4% [6] - Revenue from Established Brands in the U.S. for Respiratory- Other is expected to be $8.30 million, reflecting a year-over-year increase of +3.8% [7] - Geographic Revenue from Other International is projected to be $21.74 million, indicating a decline of -37.9% year over year [7] - Revenue from Established Brands International for Non-Opioid Pain, Bone and Dermatology- Other is expected to reach $72.24 million, suggesting a decline of -1% year over year [7] - Revenue from Established Brands International for Non-Opioid Pain, Bone and Dermatology- Diprospan is projected to be $37.63 million, reflecting a year-over-year increase of +1.7% [8] Stock Performance - Over the past month, Organon shares have returned -2.6%, contrasting with the Zacks S&P 500 composite's +2.3% change [8] - Organon currently holds a Zacks Rank 2 (Buy), indicating potential outperformance against the overall market in the near future [8]

Company Performance - Organon (OGN) closed at $9.70, reflecting a -3.39% change from the previous day's closing price, underperforming the S&P 500's daily loss of 0.37% [1] - The stock has decreased by 1.08% over the past month, lagging behind the Medical sector's loss of 0.88% and the S&P 500's gain of 2.68% [1] Earnings Forecast - Organon is expected to release earnings on August 5, 2025, with a predicted EPS of $0.94, indicating a 16.07% decline compared to the same quarter last year [2] - Revenue is anticipated to be $1.55 billion, reflecting a 3.35% decrease from the same quarter last year [2] Full Year Estimates - For the full year, analysts project earnings of $3.83 per share and revenue of $6.24 billion, marking changes of -6.81% and -2.48% respectively from the previous year [3] Analyst Estimates - Recent changes to analyst estimates for Organon indicate short-term business trends, with positive revisions suggesting analysts' confidence in the company's performance [4] Zacks Rank and Valuation - Organon currently holds a Zacks Rank of 2 (Buy), with a consensus EPS projection that has increased by 0.55% in the past 30 days [6] - The company is trading at a Forward P/E ratio of 2.62, significantly lower than the industry average of 15.82, indicating a potential discount [7] Industry Context - The Medical Services industry, part of the Medical sector, has a Zacks Industry Rank of 94, placing it in the top 39% of over 250 industries [8]

NEW YORK, July 22, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Organon & Co. ("Organon" or the "Company") (NYSE: OGN) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Organon investors who were adversely affected by alleged securities fraud between October 31, 2024 and April 30, 2025. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslra-1/organon-co-lawsuit-submission-for ...

NEW YORK , July 22, 2025 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Organon & Co.("Organon" or the "Company") (NYSE: OGN). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. Danielle Peyton Pomerantz LLP The class action concerns whether Organon and c ...