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Organon (OGN) Misses Q4 Earnings and Revenue Estimates
ZACKS· 2026-02-12 14:50
Organon (OGN) came out with quarterly earnings of $0.63 per share, missing the Zacks Consensus Estimate of $0.73 per share. This compares to earnings of $0.9 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -13.46%. A quarter ago, it was expected that this pharmaceutical company would post earnings of $0.93 per share when it actually produced earnings of $1.01, delivering a surprise of +8.6%.Over the last four quarters, the com ...
Organon & (OGN) - 2025 Q4 - Earnings Call Transcript
2026-02-12 14:32
Financial Data and Key Metrics Changes - In 2025, Organon reported $6.2 billion in revenue and $1.9 billion of adjusted EBITDA, representing a 3% decline on both a reported and ex-FX basis [6][9] - Adjusted gross margin for Q4 2025 was 56.7%, down from 60.6% in Q4 2024, primarily due to pricing pressure and unfavorable product mix [22] - Net loss for Q4 2025 was $205 million, or $0.79 per diluted share, compared to net income of $109 million, or $0.42 per diluted share in Q4 2024 [23][24] Business Line Data and Key Metrics Changes - Women's health revenue decreased 16% ex-FX in Q4 and 2% for the year, with Nexplanon sales down 20% ex-FX in Q4 and 4% for the full year [11][12] - The fertility business declined 6% ex-FX in Q4 2025 but grew 8% for the full year, driven by performance in the U.S. [14] - Biosimilars revenue was driven by Hadlima, which grew 61% ex-FX globally for the full year, reflecting strong clinical performance and pricing strategy [16] Market Data and Key Metrics Changes - Nexplanon faced challenges due to government policy-related access restrictions impacting its market share in the U.S. [12] - The JADA System generated $74 million in revenue in 2025, with its divestiture expected to impact consolidated revenue in 2026 [15] - The company anticipates strong growth in Latin America for Nexplanon, offsetting U.S. declines [14] Company Strategy and Development Direction - Organon plans to lower its dividend payout ratio to focus on debt reduction and improve its balance sheet capacity for future growth opportunities [7][8] - The company is committed to managing operating expenses and capital deployment in a disciplined manner to achieve progress on deleveraging efforts [32] - Future launches include a Pertuzumab biosimilar in the U.K. in 2027 and in the U.S. in 2028, indicating a strategic focus on expanding its biosimilars portfolio [16] Management's Comments on Operating Environment and Future Outlook - Management expects revenue and adjusted EBITDA in 2026 to be in line with 2025, projecting approximately $6.2 billion in revenue and $1.9 billion in adjusted EBITDA [9][10] - The company anticipates a modest FX tailwind to offset the loss of revenue from the JADA System divestiture [29] - Management expressed confidence in maintaining performance that aligns with the previous year while managing operating expenses effectively [32] Other Important Information - The company achieved over $200 million in cost savings in 2025, which helped offset investments in growth drivers like VTAMA [8] - Non-GAAP adjusted net income for full year 2025 was $954 million, or $3.66 per share, down from $1,065 million, or $4.11 per share in 2024 [24] Q&A Session Summary Question: Concerns about channel behavior issues and audit committee investigation scope - Management stated they cannot provide additional details at this time [36] Question: Status of FDA draft guidance on biosimilars and its impact - Management views the guidance as incremental and believes their strategy for biosimilars is appropriate [40] Question: Nexplanon contribution to 2026 sales guidance - Nexplanon is expected to be roughly flat year-on-year, with growth anticipated in ex-U.S. markets [41][42] Question: Operating expense savings and underlying EBITDA performance - Management confirmed that some savings will be redirected to revenue growth opportunities while continuing to manage operating expenses aggressively [46] Question: Update on CEO search - No public update was provided regarding the search for a permanent CEO [62] Question: Strategy for Denosumab biosimilar in the osteoporosis market - Management indicated that the market will be competitive, and peak revenues for the Denosumab product are estimated at around $100 million over five years [63]
Organon & (OGN) - 2025 Q4 - Earnings Call Transcript
2026-02-12 14:32
Financial Data and Key Metrics Changes - In 2025, Organon reported $6.2 billion in revenue and $1.9 billion of adjusted EBITDA, representing a 3% decline on both a reported and ex-FX basis [6] - Adjusted gross margin for Q4 2025 was 56.7%, down from 60.6% in Q4 2024, primarily due to pricing pressure and unfavorable product mix [22] - Net loss for Q4 2025 was $205 million, or $0.79 per diluted share, compared to net income of $109 million, or $0.42 per diluted share in Q4 2024 [23] Business Line Data and Key Metrics Changes - Women's health revenue decreased 16% ex-FX in Q4 and 2% for the year, with Nexplanon sales down 20% ex-FX in Q4 and 4% for the full year [11] - The fertility business declined 6% ex-FX in Q4 2025 but grew 8% ex-FX for the full year, driven by performance in the U.S. [14] - Biosimilars revenue was driven by HADLIMA, which grew 61% ex-FX globally for the full year [16] Market Data and Key Metrics Changes - Nexplanon faced challenges due to government policy-related access restrictions impacting its market share in the U.S. [12] - The JADA System generated $74 million in revenue in 2025 before its divestiture, which will impact consolidated revenue in 2026 [15] - The company expects strong growth in Latin America for Nexplanon, offsetting U.S. declines [14] Company Strategy and Development Direction - Organon decided to lower its dividend payout ratio to focus on debt reduction and improve its balance sheet capacity for future growth opportunities [7] - The company is scrutinizing spending and has discontinued early-stage clinical programs to focus on products already in the market [9] - For 2026, Organon expects to maintain revenue and adjusted EBITDA in line with 2025, targeting approximately $6.2 billion in revenue and $1.9 billion in adjusted EBITDA [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 2026 targets despite anticipated gross margin deterioration and ongoing operational challenges [10] - The company is committed to managing operating expenses and capital deployment to support deleveraging efforts [32] - Management highlighted the importance of maintaining performance aligned with the previous year while navigating a competitive landscape [32] Other Important Information - The company divested the JADA System, resulting in approximately $390 million in net proceeds to reduce net debt in 2026 [8] - Organon expects to achieve net leverage below 4x by the end of 2026, supported by debt repayments and revenue from the JADA divestiture [27] Q&A Session Summary Question: Concerns about channel behavior issues and audit committee investigation scope - Management could not provide additional details regarding the audit committee's findings beyond what was previously disclosed [36] Question: Status of FDA draft guidance on biosimilars and its impact - Management views the FDA guidance as incremental and believes their current biosimilar strategy is appropriate for future growth [40] Question: Nexplanon contribution to 2026 sales guidance - Nexplanon is expected to be roughly flat year-on-year, with growth anticipated outside the U.S. but a dip in the U.S. due to the transition to a five-year label [41] Question: Operating costs and margins outlook - Management emphasized the need to streamline operations while ensuring that cost reductions do not hinder revenue growth opportunities [51] Question: Pressure on established brands and competitive dynamics for Vtama - Management expects established brands to stabilize but acknowledges potential challenges, particularly in the respiratory segment [58]
Organon & (OGN) - 2025 Q4 - Earnings Call Transcript
2026-02-12 14:30
Financial Data and Key Metrics Changes - In 2025, Organon reported $6.2 billion in revenue, a decrease of 3% on both a reported and ex-FX basis [5] - Adjusted EBITDA for 2025 was $1.9 billion, with adjusted EBITDA margins remaining flat compared to 2024 despite a 150 basis points decline in gross margin [8][10] - The net loss for Q4 2025 was $205 million, or $0.79 per diluted share, compared to a net income of $109 million, or $0.42 per diluted share in Q4 2024 [23][24] Business Line Data and Key Metrics Changes - Women's health revenue decreased by 16% ex-FX in Q4 and 2% for the full year, with Nexplanon sales down 20% ex-FX in Q4 and 4% for the year [11] - The fertility business declined 6% ex-FX in Q4 but grew 8% for the full year, driven by performance in the U.S. [13] - Biosimilars revenue was driven by Hadlima, which grew 61% ex-FX globally for the full year [15] Market Data and Key Metrics Changes - The U.S. market faced headwinds due to government policy-related access restrictions impacting Nexplanon sales [12] - Internationally, particularly in Latin America, there was improved access contributing to growth in Nexplanon [43] - The divestiture of the JADA System resulted in approximately $390 million in net proceeds, impacting consolidated revenue in 2026 [8][9] Company Strategy and Development Direction - The company decided to lower its dividend payout ratio to focus on debt reduction and improve its balance sheet capacity for future growth opportunities [7] - Organon is committed to managing operating expenses and capital deployment in a disciplined manner to achieve progress on deleveraging efforts [33] - The company expects to maintain revenue and adjusted EBITDA in 2026 at levels similar to 2025, with a focus on cost savings and operational efficiency [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in delivering results in 2026, despite anticipated challenges in gross margin and operating expenses [10] - The company expects a flat revenue outlook for Nexplanon in 2026, with growth anticipated in international markets [42][43] - Management acknowledged the competitive environment in the U.S. for the fertility business and the potential headwinds from the transition to a five-year label for Nexplanon [13][54] Other Important Information - Organon achieved over $200 million in cost savings in 2025, which helped offset investments in growth drivers [8] - The company expects adjusted gross margin in 2026 to decline by 75-100 basis points compared to the prior year [29] - Free cash flow for 2025 was $960 million, consistent with the prior year, with expectations for similar performance in 2026 [25] Q&A Session Summary Question: Concerns about channel behavior issues and audit committee scope - Management could not provide additional details regarding the audit committee's findings [37] Question: Status of biosimilar policy and its impact on Organon's business - Management views the FDA's draft guidance as an incremental change and remains optimistic about growth opportunities in biosimilars [41] Question: Nexplanon's contribution to 2026 sales guidance - Nexplanon is expected to be roughly flat year-on-year, with growth anticipated in international markets [42][43] Question: Operating expense savings and underlying EBITDA performance - Management confirmed that some of the $275 million in savings would be redirected to revenue growth opportunities [47] Question: Update on the search for a permanent CEO - No public update was available regarding the CEO search [64] Question: Strategy for the Denosumab biosimilar - Management indicated that the peak revenues for the Denosumab product could reach around $100 million over five years [65]
Organon & (OGN) - 2025 Q4 - Earnings Call Presentation
2026-02-12 13:30
Organon Fourth Quarter and Full Year 2025 Earnings Disclaimer statement Cautionary Note Regarding Non-GAAP Financial Measures This presentation 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 measure ...
Organon & (OGN) - 2025 Q4 - Annual Results
2026-02-12 12:45
Revenue Performance - Full year 2025 revenue was $6.2 billion, down 3% on both an as-reported basis and at constant currency compared to 2024[3]. - Fourth quarter 2025 revenue was $1.507 billion, down 5% as-reported and down 8% excluding foreign currency impact compared to Q4 2024[5]. - Women's Health revenue declined 15% as-reported and 16% ex-FX in Q4 2025, primarily due to a 20% decrease in Nexplanon sales[6]. - Biosimilars revenue increased 11% as-reported and ex-FX in Q4 2025, driven by strong performance of Hadlima and contributions from new assets[7]. - Total revenues for the year ended December 31, 2025, were $6,216 million, a decrease from $6,403 million in 2024, representing a decline of 2.9%[51]. - The U.S. market generated $1,604 million in revenues for the year ended December 31, 2025, compared to $1,572 million in 2024, reflecting a growth of 2%[51]. - International revenues for the year ended December 31, 2025, were $4,612 million, down from $4,831 million in 2024, indicating a decline of 4.5%[51]. - Nexplanon/Implanon NXT sales for the year ended December 31, 2025, were $921 million, a decrease from $963 million in 2024, representing a decline of 4.4%[48]. Profitability and Loss - Full year 2025 net income was $187 million, or $0.72 per diluted share, down 78% from $864 million, or $3.33 per diluted share in 2024[25]. - Net loss for Q4 2025 was $205 million, or $0.79 per diluted share, compared to net income of $109 million, or $0.42 per diluted share in Q4 2024[13]. - The company reported a net loss of $205 million for Q4 2025, compared to a net income of $109 million in Q4 2024[46]. - The non-GAAP adjusted net income for the year ended December 31, 2025 was $954 million, down from $1,065 million in 2024[58]. - The GAAP diluted loss per share for Q4 2025 was $(0.79), while the non-GAAP adjusted diluted earnings per share was $0.63, compared to $0.90 in Q4 2024[59]. Adjusted EBITDA and Margins - Full year 2025 Adjusted EBITDA was $1.91 billion, representing a 30.7% Adjusted EBITDA margin[3]. - Adjusted EBITDA for the year ended December 31, 2025 was $1,907 million, slightly down from $1,958 million in 2024, with an adjusted EBITDA margin of 30.7%[60]. - Adjusted EBITDA for 2026 is projected to be around $1.9 billion, similar to the previous year[30]. - The adjusted non-GAAP gross margin for the year ended December 31, 2025, was 60.1%, down from 61.6% in 2024, indicating a need for improved operational efficiency[55]. - Adjusted gross margin is expected to be approximately 75-100 basis points lower than 60.1% in 2025[32]. Future Guidance - The company expects to deliver approximately $6.2 billion of revenue and approximately $1.9 billion of Adjusted EBITDA for the full year 2026, in line with 2025 performance[3]. - For full year 2026, the company expects revenue of approximately $6.2 billion, consistent with 2025 performance[30]. - The company anticipates nominal revenue growth to be approximately flat, compared to a decline of 3% in 2025[32]. - The impact of foreign exchange translation is expected to be approximately $75 million in 2026, compared to $35 million in 2025[32]. - The effective non-GAAP tax rate for 2026 is projected to be between 27.5% and 29.5%, up from 24.4% in 2025[32]. - The company plans to maintain SG&A expenses in the mid-20% range, down from 26.1% in 2025[32]. - Research and development expenses are expected to be in the mid-single digit range, compared to 5.5% in 2025[32]. Cash and Debt Position - As of December 31, 2025, cash and cash equivalents were $574 million, and total debt was $8.64 billion[28]. - The company reported $121 million in interest expense for the year ended December 31, 2025, compared to $520 million in 2024[60]. - Restructuring and related charges amounted to $105 million for the year ended December 31, 2025[60]. - The company incurred a goodwill impairment of $301 million for the three months ended December 31, 2025[60]. - The company reported a pre-tax gain of $69 million related to the repurchase and cancellation of approximately $419 million of its 5.125% notes due in 2031[64]. Dividends and Shareholder Returns - The Board of Directors declared a quarterly dividend of $0.02 per share, payable on March 12, 2026[27]. - The weighted average shares outstanding for 2025 was approximately 261 million, with a projected increase to around 265 million for 2026[32]. - The company reported adjusted non-GAAP selling, general, and administrative expenses of $1,623 million for the year ended December 31, 2025, compared to $1,571 million in 2024, an increase of 3.3%[55].
Organon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2025
Businesswire· 2026-02-12 12:30
JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon announces Q4 2025 and Full Year 2025 earnings results, ending December 31, 2025. ...
Organon Completes Divesture of JADA System to Laborie Medical
ZACKS· 2026-01-29 19:31
Core Insights - Organon & Co. has completed the divestiture of its JADA System to Laborie Medical Technologies for up to $465 million, which includes $440 million paid at closing and a potential earn-out of up to $25 million based on 2026 revenue targets [1][7] Company Developments - The JADA team has assisted over 136,000 women across more than 20 countries, establishing JADA as a widely accepted treatment for postpartum hemorrhage [2][8] - The divestiture is expected to strengthen Organon's balance sheet and support its capital allocation strategy for growth opportunities in women's health biopharmaceuticals [2][4] - The net proceeds from the sale will likely be used for debt reduction, aligning with Organon's goal to lower its net-debt-to-adjusted EBITDA ratio, thereby enhancing its capacity for targeted reinvestment or acquisitions [4][9] Market Performance - Following the announcement of the divestiture, Organon shares declined by 1.2%, with a total decline of 11.5% over the past six months, contrasting with the industry's growth of 12.6% and the S&P 500's rise of 12.2% [3] Industry Context - The postpartum hemorrhage treatment market was valued at $1.6 billion in 2025 and is projected to grow at a CAGR of 5.3% through 2032, driven by factors such as rising maternal mortality rates and the standardization of PPH care bundles in hospitals [11]
Organon Completes Divestiture of JADA® System to Laborie
Businesswire· 2026-01-28 17:45
Core Insights - Organon has successfully closed the sale of its JADA® System to Laborie Medical Technologies Corp [1] Company Summary - The transaction marks a significant strategic move for Organon, indicating a focus on optimizing its portfolio [1] - Laborie Medical Technologies Corp is now the owner of the JADA® System, which may enhance its product offerings in the medical technology sector [1]
Orogen Royalties' Exploration Stage Projects and Royalties Update and 2026 Outlook
Accessnewswire· 2026-01-26 12:30
Core Insights - Orogen Royalties Inc. announced significant updates regarding its partner-funded exploration projects and royalties, highlighting a strong performance in 2025 and an optimistic outlook for 2026 [1] 2025 Highlights - Over 37,800 metres of partner-funded drilling were conducted, with an estimated expenditure of $30 million, including more than 21,000 metres focused on resource expansion and conversion at the Navidad/Winter vein target and the Luna zone at the Ermitaño gold-silver mine in Mexico [1] - The company received over $4.1 million from project sales and payments from exploration partners [1] - Four new royalties and three exploration alliances were established, generating over $3.4 million in generative exploration expenditures for copper and gold targets, with more than $2.5 million contributed by alliance partners across western United States and Canada [1] 2026 Outlook - The company plans twelve partner-funded drilling programs totaling an estimated 40,000 metres, excluding drilling plans at the Ermitaño [1] - Three partner-funded alliances will continue in 2026 with Altius Minerals Corp., South32 Limited, and Triple Flag Precious Metals Corp. [1] - Six projects are currently under option to industry partners, with updates expected on resources at the Navidad/Winter gold-silver veins at Ermitaño and ongoing exploration and resource expansion drilling at the MPD South porphyry copper-gold project in British Columbia [1] - The CEO of Orogen noted that the prospect generation business achieved record levels in 2025 for early-stage generative exploration expenditures by alliance partners, drilling metres, and new mineral resource estimates [1]