Core Insights - Organon reported fiscal Q2 2025 results with GAAP revenue of $1.59 billion, exceeding analyst expectations, but both revenue and earnings declined compared to the previous year [1][2] - The company is focusing on new product growth while facing challenges with its legacy product portfolio [1][4] Financial Performance - GAAP revenue for Q2 2025 was $1.59 billion, slightly down from $1.61 billion in Q2 2024, but above estimates by $42 million [2][5] - Non-GAAP adjusted EPS was $1.00, beating the consensus estimate of $0.95, but down 11% from $1.12 in Q2 2024 [2][5] - Net income (GAAP) fell to $145 million from $195 million year-over-year, a decline of 25.6% [2][10] - Adjusted EBITDA (non-GAAP) increased by 1.8% to $522 million, with a margin improvement to 32.7% [2][9] Business Segments - Women's Health segment generated $462 million in sales, up 3%, driven by a 15% increase in fertility treatments [5][6] - Biosimilars revenue rose 5% to $173 million, primarily due to Hadlima, which contributed $50 million [6][8] - Established brands revenue was $936 million, down 3% year-over-year, with notable declines in Atozet and Singulair due to competition [7][8] Strategic Focus - Organon is prioritizing growth in women's health, diversifying its biosimilars portfolio, and managing its mature product lines amid generic competition [4][12] - The company aims to launch new products and expand internationally while managing costs and reducing debt [4][11] Outlook - Full-year revenue guidance for 2025 was raised to $6.275 billion–$6.375 billion, reflecting improved expectations due to foreign exchange factors [12] - Adjusted EBITDA margin guidance remains at 31.0%–32.0%, with a focus on achieving a net leverage ratio below 4.0x by year-end 2025 [12][13]

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]

Core Viewpoint - A securities class action lawsuit has been filed against Organon & Co. for alleged misrepresentations regarding its capital allocation priorities and risks associated with its product Nexplanon during the class period from November 3, 2022, to April 30, 2025 [1][3][4] Company Overview - Organon & Co. is a healthcare company based in Jersey City, NJ, focusing on women's health [2] - In October 2024, Organon acquired Dermavant, a biopharmaceutical company, for $1.2 billion [2] Lawsuit Details - The lawsuit claims that despite increasing debt from the Dermavant acquisition, Organon assured investors it would maintain its dividend as its "1 capital allocation priority" [3] - It is alleged that after the acquisition, Organon shifted its capital allocation focus towards reducing debt rather than maintaining dividends [3] - The lawsuit also states that Organon failed to disclose the heightened risk of loss of exclusivity and price erosion related to its product Nexplanon [4]

SAN DIEGO, July 21, 2025 (GLOBE NEWSWIRE) -- The law firm of Robbins Geller Rudman & Dowd LLP announces that it has filed a class action lawsuit seeking to represent purchasers of Organon & Co. (NYSE: OGN) publicly traded securities between November 3, 2022 and April 30, 2025, inclusive (the "Class Period"). Captioned Lerner v. Organon & Co., No. 25-cv-12983 (D.N.J.), the Organon class action lawsuit charges Organon as well as certain of Organon's top executives with violations of the Securities Exchange Ac ...

Core Viewpoint - Rosen Law Firm is reminding investors who purchased Organon & Co. securities during the specified class period of the upcoming lead plaintiff deadline for a class action lawsuit [1][2]. Group 1: Class Action Details - The class period for the lawsuit is from November 3, 2022, to April 30, 2025, and investors may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [1]. - A class action lawsuit has already been filed, and interested parties must move the court to serve as lead plaintiff by July 22, 2025 [2]. Group 2: Law Firm Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved the largest securities class action settlement against a Chinese company at the time and being ranked No. 1 for the number of settlements in 2017 [3]. - The firm has recovered hundreds of millions of dollars for investors, securing over $438 million in 2019 alone [3]. Group 3: Case Allegations - The lawsuit alleges that Organon made false or misleading statements regarding its product Nexplanon, including an overstated long-term sales growth projection that would not reach $1 billion by the end of fiscal year 2025 [4]. - It is claimed that Organon was not on track to achieve the required $1 billion in free cash flow to sustain its dividend, nor maintain its corporate debt ratings [4].

Core Viewpoint - A class action lawsuit has been filed against Organon & Co. for alleged violations of the Securities Exchange Act of 1934, claiming misleading statements regarding the company's financial health and projections during the Class Period from November 3, 2022, to April 30, 2025 [1][4]. Company Allegations - The lawsuit alleges that Organon misrepresented the risk of loss of exclusivity and price erosion for its product Nexplanon, leading to inflated sales growth expectations that would not reach $1 billion by the end of fiscal year 2025 [4]. - It is claimed that Organon was not on track to achieve a $1 billion milestone payment from Merck & Co. related to Nexplanon sales, nor maintain the required $1 billion in free cash flow to sustain its dividend [4]. - The lawsuit further asserts that Organon might not maintain its corporate debt ratings and leverage levels, which could impact its financial stability [4]. Financial Impact - Following the announcement of its first quarter 2025 financial results, Organon reduced its dividend by 90%, from $1.16 per share annually to $0.08 per share annually, which led to a stock price drop of over 27% [5].

NEW YORK, July 16, 2025 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Organon & Co. (NYSE: OGN) between November 3, 2022 and April 30, 2025, both dates inclusive (the “Class Period”), of the important July 22, 2025 lead plaintiff deadline. SO WHAT: If you purchased Organon securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. WHAT TO DO ...

Core Viewpoint - A class action lawsuit has been filed against Organon & Co. for alleged violations of the Securities Exchange Act of 1934, claiming misleading statements regarding the company's financial health and projections during the Class Period from November 3, 2022, to April 30, 2025 [1][4]. Group 1: Allegations and Financial Impact - The lawsuit alleges that Organon misrepresented the risk of loss of exclusivity and price erosion for its product Nexplanon, leading to inflated sales growth expectations that would not meet the projected $1 billion milestone by the end of fiscal year 2025 [4]. - It is claimed that Organon was not on track to achieve the required $1 billion in free cash flow to sustain its dividend, which was subsequently slashed by 90% from $1.16 per share annually to $0.08 per share annually [5]. - Following the announcement of the dividend cut, Organon's stock price fell by more than 27%, indicating a significant market reaction to the news [5]. Group 2: Legal Process and Representation - The lawsuit allows any investor who purchased Organon securities during the Class Period to seek appointment as lead plaintiff, representing the interests of the class [7]. - Robbins Geller Rudman & Dowd LLP, the law firm representing the plaintiffs, has a strong track record in prosecuting investor class actions and has recovered over $2.5 billion for investors in 2024 alone [8][9].