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Question-and-Answer SessionAnd so certainly lots to talk about. And I wanted to dive right into my questions. And let's just start with the internal investigation and the completion of that. And just as a refresher for people here and listening in on the webcast, just talk about the conclusion of the investigation and then also talk about your remediation efforts.Joseph MorrisseyInterim CEO & Executive VP and Head of Manufacturing & Supply Yes, sure. Well, it's great to be here. Yes, the conclusion of inves ...

Summary of Organon Conference Call Company Overview - **Company**: Organon - **Event**: 37th Annual Piper Sandler Healthcare Conference - **Speakers**: Joe Morrissey (Interim CEO), Matt Walsh (CFO) Key Points Internal Investigation and Remediation - An internal investigation focused on sales practices related to Nexplanon and two wholesalers was concluded, identifying a weakness in the "tone at the top" [2][3] - A detailed remediation plan has been approved by the audit committee, emphasizing ethics training and mechanisms for employees to escalate concerns [2][3] - The investigation found that revenue management around quarter-end orders affected less than 1% of annual revenue and 2% in any quarter, confirming that revenue recognition practices were appropriate [3][5] Financial Performance and Cost Discipline - In 2025, Organon achieved a reduction of $200 million in operating expenses, with continued cost discipline expected in 2026 [11][14] - The adjusted EBITDA margin target of 31% for 2026 is considered challenging due to flattening Nexplanon sales and ongoing investments in Vtama [14][18] Research and Development (R&D) Strategy - The primary R&D focus is on maximizing the value of existing products, including Vtama, while deprioritizing larger, longer-term programs [21][28] - Organon aims to evolve into a more commercially focused organization, potentially leading to significant cuts in the R&D budget [28][30] Nexplanon Product Outlook - Nexplanon is expected to face flat to declining sales in the U.S. due to Title X funding challenges and policy changes affecting Planned Parenthood [39][44] - Internationally, Nexplanon continues to grow, with recent reimbursement wins in Brazil [53][41] - The product lost exclusivity in Europe, but generics have not yet entered the market [44][46] Vtama Sales Performance - Vtama's 2025 sales guidance was lowered due to challenges in volume growth and gross-to-net moderation, with access improving from less than 40% to around 70%-80% in preferred tiers [75][80] - The competitive landscape for topical dermatology products is challenging, but Vtama is positioned to compete based on its efficacy and safety profile [100][102] Established Brands and Market Challenges - Respiratory products, particularly Singulair and Dulera, are facing significant headwinds due to price reductions and loss of contracts [122][136] - The impact of Atozet's loss of exclusivity (LOE) is expected to be less than $75 million in 2026, compared to over $200 million in 2025 [154] Growth Opportunities - Emgality is performing well, with expansion into 22 markets, showcasing Organon's capability to leverage its global infrastructure for growth [156][161] - Organon is open to acquiring additional dermatology-focused assets to capitalize on its existing sales force and capabilities [111][112] Biosimilars and Divestitures - Biosimilars are viewed as a growth driver, with successful launches of Hadlima and plans for further expansion [168][172] - Divestitures will be approached opportunistically to improve capital structure and accelerate deleveraging [180][183] Additional Insights - The company is focused on maintaining a strong balance sheet while exploring strategic partnerships and acquisitions that align with its core capabilities [111][162] - The competitive dynamics in the dermatology space and the broader healthcare market are acknowledged as critical factors influencing future performance [100][102]

Core Insights - The biopharmaceutical license application (BLA) for Pertuzumab injection (420mg/14mL) POHERDY has been approved by the U.S. Food and Drug Administration (FDA), making it the first and only biosimilar to PERJETA (pertuzumab) in the U.S. market [1][1][1] - This approval allows for interchangeability with the original product PERJETA and covers all indications for which PERJETA has been approved in the U.S. [1][1][1] - The approval represents a significant milestone in improving access to high-quality and potentially more affordable treatment options for patients with specific HER2-positive breast cancer [1][1][1]

Core Insights - Organon and Henlius have received FDA approval for POHERDY, marking it as the first and only pertuzumab biosimilar in the US that is interchangeable with Perjeta [1] Company Summary - The approval of POHERDY represents a significant milestone for Organon and Henlius in the biosimilar market, particularly for treatments related to breast cancer [1] - This development may enhance competition in the oncology sector, potentially leading to cost savings for patients and healthcare systems [1] Industry Summary - The introduction of POHERDY as an interchangeable biosimilar could influence the dynamics of the oncology drug market in the US, promoting greater accessibility to essential treatments [1] - The approval aligns with ongoing trends in the pharmaceutical industry towards the development and acceptance of biosimilars, which are designed to provide more affordable alternatives to existing biologic therapies [1]

Group 1 - The article discusses the importance of staying updated on stocks in the biotech, pharma, and healthcare sectors, highlighting key trends and catalysts that influence market valuations [1] - Edmund Ingham, a biotech consultant with over 5 years of experience, leads the Haggerston BioHealth investing group, which caters to both novice and experienced investors [1] - The investing group provides insights on catalysts, buy and sell ratings, product sales forecasts, integrated financial statements, discounted cash flow analysis, and market-specific analyses for major pharmaceutical companies [1]

Core Insights - Organon reported third-quarter adjusted earnings of $1.01 per share, exceeding the consensus estimate of 94 cents, and quarterly sales of $1.602 billion, surpassing Wall Street's estimate of $1.56 billion [1] - The company lowered its fiscal sales guidance from a range of $6.275 billion-$6.375 billion to $6.20 billion-$6.25 billion, which is below the consensus of $6.289 billion [1] Financial Performance - The adjusted earnings per share for the third quarter were $1.01, beating expectations [1] - Quarterly sales reached $1.602 billion, exceeding the forecast [1] Management Commentary - Joe Morrissey, the Interim CEO, emphasized the company's strengths and projected over $900 million in free cash flow for the year, while also focusing on cost discipline and debt reduction [2] - The management aims to create additional balance sheet capacity to pursue growth opportunities in women's health [2] Stock Performance - Following the earnings announcement, Organon shares fell by 3.4%, trading at $7.44 [2] Analyst Ratings - Morgan Stanley's Terence Flynn maintained an Equal-Weight rating and reduced the price target from $10 to $9 [5] - JP Morgan's Chris Schott kept an Underweight rating and lowered the price target from $14 to $12 [5]

Core Insights - Organon reported $1.6 billion in revenue for Q3 2025, a year-over-year increase of 1.3% and an EPS of $1.01, up from $0.87 a year ago, exceeding Zacks Consensus Estimates for both revenue and EPS [1] Revenue Performance - Revenue from Established Brands in the U.S. for Respiratory (Clarinex) was $1 million, matching the average estimate [4] - Revenue from Established Brands in the U.S. for Non-Opioid Pain, Bone, and Dermatology (Other) was $4 million, a decrease of 20% year-over-year, below the average estimate of $4.87 million [4] - Revenue from Women's Health International (NuvaRing) was $17 million, slightly above the average estimate of $16.73 million, with no year-over-year change [4] - Revenue from Women's Health U.S. (NuvaRing) was $9 million, exceeding the average estimate of $6.48 million, representing a 28.6% increase year-over-year [4] - Revenue from Women's Health (Nexplanon/Implanon NXT) was $223 million, below the average estimate of $246.08 million, reflecting an 8.2% decrease year-over-year [4] - Total revenue from Established Brands was $956 million, slightly above the average estimate of $925.97 million, with a 0.5% year-over-year increase [4] - Total revenue from Biosimilars was $196 million, exceeding the average estimate of $167.07 million, with an 18.8% year-over-year increase [4] - Total revenue from Women's Health was $429 million, below the average estimate of $456.13 million, representing a 2.5% year-over-year decrease [4] - Total revenue from Other was $21 million, in line with the average estimate of $21.14 million, reflecting a 19.2% year-over-year decrease [4] - Revenue from Women's Health (NuvaRing) was $26 million, exceeding the average estimate of $23.21 million, with a 13% year-over-year increase [4] - Revenue from Biosimilars (Renflexis) was $70 million, slightly above the average estimate of $63.61 million, with a 2.8% year-over-year decrease [4] Stock Performance - Organon's shares have returned -29.4% over the past month, contrasting with the Zacks S&P 500 composite's +0.3% change, indicating underperformance [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]

Financial Data and Key Metrics Changes - Third quarter revenue was $1.6 billion, with adjusted EBITDA of $518 million, representing an adjusted EBITDA margin of 32.3% [13][30] - The company is lowering its full-year revenue guidance to $6.2 billion-$6.25 billion, reflecting a year-over-year nominal decline of 3.2%-2.4% [33] - Adjusted gross margin for the third quarter was 60.3%, down from 61.7% in the same quarter of 2024, primarily due to pricing pressure and unfavorable product mix [29][30] Business Line Data and Key Metrics Changes - Women's health franchise revenue declined 4% in the third quarter compared to the same period in 2024, with a 9% decline in Nexplanon sales [17] - Global Nexplanon sales were $223 million in the third quarter, with a 50% decline in the U.S. and a 7% growth internationally [17][18] - The fertility business was flat in the third quarter but up 13% year-to-date, with expectations of high single-digit growth for the full year [19] - Hadlima, a biosimilar, saw a 63% increase in sales year-to-date, contributing significantly to the biosimilars segment [21] Market Data and Key Metrics Changes - The U.S. market for Nexplanon faced challenges due to unfavorable policy changes impacting budget-constrained public segments [17][18] - The respiratory business is experiencing declines, particularly in Singulair and Dulera, due to competitive pressures and mandatory price reductions [24][25] Company Strategy and Development Direction - The company remains focused on deleveraging, driving cost savings, and achieving revenue growth [12][38] - A definitive agreement was made to divest the JADA system for $440 million, which will help in faster deleveraging [20] - The company is committed to enhancing operational performance and aligning resources to strategic priorities [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating current headwinds and emphasized the importance of operational excellence [10][38] - The company anticipates that the discontinuation of certain sales practices will have a significant impact on future revenue [15][19] - Management expects Nexplanon sales to be down mid to high single digits for the full year in the U.S. but anticipates international growth [18][19] Other Important Information - The independent internal investigation regarding improper sales practices has concluded, and remediation efforts are underway [9][48] - The company is not planning any additional divestitures at this time but will continue to evaluate its portfolio strategically [40] Q&A Session Summary Question: Are there opportunities for additional divestitures within the portfolio? - The company is constantly evaluating its assets but has no definitive plans for further divestitures at this time [40] Question: When should growth inflection for Vtama be expected? - Significant strides have been made to improve access, and 2026 is seen as a key year for evaluating growth trajectory [41] Question: Can you elaborate on the pressure on the respiratory business? - The respiratory business is expected to continue facing challenges due to competitive pressures and mandatory price reductions [42][43] Question: What are the expectations for Denosumab and its impact on future revenue? - The company is excited about Denosumab's launch and anticipates it will contribute positively to the biosimilars segment [54] Question: How is the CEO search progressing? - The search committee is actively working to find a permanent CEO, with no strategic changes anticipated in the interim [51]

Financial Performance - Revenue for Q3 2025 was $1602 million, a 1% increase compared to Q3 2024[13] - Adjusted EBITDA for Q3 2025 was $518 million, with a 323% Adjusted EBITDA margin[13] - Adjusted diluted EPS for Q3 2025 was $101, compared to $087 in Q3 2024, a 16% increase[13] - The full-year revenue range is revised to $6200 million - $6250 million, with an Adjusted EBITDA margin guidance revised to approximately 310%[13] - Free Cash Flow before one-time costs YTD September 2025 was $813 million, compared to $693 million in 2024[32] Revenue Analysis by Segment - Total Women's Health revenue was $429 million in Q3 2025, a decrease of 3% compared to Q3 2024[17] However, year-to-date Women's Health revenue increased by 3% to $1354 million[15,17] - Nexplanon revenue was $223 million in Q3 2025, a decrease of 8% compared to Q3 2024[17] - Total Biosimilars revenue was $196 million in Q3 2025, a 19% increase compared to Q3 2024[20] Year-to-date Biosimilars revenue increased by 2% to $510 million[20] - Hadlima revenue increased by 57% to $63 million in Q3 2025[20] - Total Established Brands revenue was $956 million in Q3 2025, a 1% increase compared to Q3 2024[24] Year-to-date Established Brands revenue decreased by 5% to $2778 million[24] Geographic Performance - United States revenue increased by 2% to $406 million in Q3 2025[56] - Europe and Canada revenue decreased by 4% to $417 million in Q3 2025[56] - Latin America, Middle East, Russia and Africa revenue increased by 18% to $286 million in Q3 2025[56] Guidance - Full-year revenue guidance is revised to $6200 million - $6250 million, representing a nominal revenue growth of (32%) - (24%)[39] - Adjusted EBITDA margin guidance is revised to approximately 310%[39]