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Amneal Pharmaceuticals (NasdaqGS:AMRX) FY Earnings Call Presentation
2026-01-14 00:30
Financial Performance & Growth - Amneal's net revenues increased from $1.6 billion in 2019 to $3.0 - $3.1 billion in 2025, reflecting a Compound Annual Growth Rate (CAGR) of +7% to +11%[14] - Adjusted EBITDA grew from $339 million in 2019 to $675 million - $685 million in 2025, with a CAGR of +8% to +9%[14] - Operating cash flow increased significantly from $2 million in 2019 to an estimated $300 million - $330 million in 2025[14] - Total company revenue for FY 2024 was $2.794 billion, with a +9% historical growth rate (2020-2024 CAGR) and a high single-digit growth projection[18] Portfolio & Pipeline - The company has a growing portfolio of 280+ affordable medicines across complex dosage forms[10] - The company has 69 pending ANDAs (Abbreviated New Drug Applications), with 64% being non-oral solids[14] - The company has 44 pipeline products, with 95% being non-oral solids[14] - The company has 3 commercial biosimilars and 5 biosimilars in the pipeline[14] Market & Strategy - The company is targeting the GLP-1/Peptides market, which is projected to grow from $26 billion in 2025 to $50 billion in 2030[16] - The company expects $300-500 million in U S peak sales for CREXONT® for Parkinson's Disease[19] - The company expects $50-100 million in U S peak sales for Brekiya® for migraine[24]
Amneal Announces Positive Interim Phase 4 ELEVATE-PD Results With CREXONT® for Parkinson's Disease
Globenewswire· 2025-12-05 13:00
Core Insights - Amneal Pharmaceuticals announced positive interim results from its Phase 4 ELEVATE-PD study for CREXONT, a new treatment for Parkinson's disease, showcasing significant clinical benefits for patients [1][2]. Group 1: Study Results - The first 55 patients in the study showed substantial improvements after six weeks of treatment with CREXONT, including an increase in daily "Good On" time by 1.86 hours, a reduction in "Off" time by 0.77 hours, and an increase in "Good On" time per dose by 0.79 hours [3][4]. - The MDS-UPDRS total score improved by an average of -14.2 points, indicating enhanced motor function [4]. - CREXONT demonstrated a longer duration of benefit with each dose compared to other oral carbidopa/levodopa therapies, highlighting its differentiated clinical performance [4][5]. Group 2: Safety and Efficacy - Treatment-emergent adverse events (TEAEs) were generally mild to moderate, with common side effects including nausea (5.5%), falls (3.6%), dizziness (3.6%), and urinary tract infection (3.6%) [6]. - The ongoing ELEVATE-PD study aims to provide longer-term data and patient-reported outcomes in 2026, further supporting CREXONT's impact on motor symptom control and functional independence [6][8]. Group 3: Product Information - CREXONT is an innovative formulation that combines immediate-release granules and extended-release pellets, designed to optimize levodopa delivery and absorption, providing the longest-lasting plasma levels of any oral CD/LD therapy available [2][7]. - The ELEVATE-PD study is an open-label, multi-center clinical trial designed to evaluate the real-world efficacy and safety of switching to CREXONT in adults with moderately severe Parkinson's disease [8].
Amneal Pharmaceuticals(AMRX) - 2025 Q3 - Earnings Call Presentation
2025-10-30 12:30
Financial Performance - Q3 2025 revenue reached $785 million, a 12% increase compared to Q3 2024[5] - Adjusted EBITDA for Q3 2025 was $160 million, a 1% increase year-over-year[5] - Adjusted EPS for Q3 2025 was $017, a 6% increase compared to Q3 2024[5] - The company updates 2025 guidance for adjusted EBITDA between $675 million to $685 million and adjusted EPS of $075 to $080[5] Segment Performance - AvKARE segment experienced substantial revenue growth of 24% in Q3[5] - Specialty segment grew 8% in Q3, driven by CREXONT® and UNITHROID®[5] - Affordable Medicines segment grew 8% in Q3, driven by complex products and new launches[5] Product and Pipeline - CREXONT® uptake continues with approximately 17000 Parkinson's patients on therapy[5] - Brekiya® DHE autoinjector launched for migraine & cluster headache[5] - Biosimilars portfolio poised to expand, including BLA submission for bXOLAIR® in September[5]
Amneal Reports Third Quarter 2025 Financial Results
Globenewswire· 2025-10-30 10:00
Core Insights - Amneal Pharmaceuticals reported a strong Q3 2025 with net revenue of $785 million, a 12% increase from $702 million in Q3 2024, and a GAAP net income of $2 million compared to a net loss of $0.2 million in the same quarter last year [1][3][4]. Financial Performance - Q3 2025 Adjusted EBITDA was $160 million, reflecting a 1% increase from the previous year, driven by higher revenue and gross profit, despite increased commercial investments [5]. - Adjusted diluted earnings per share (EPS) for Q3 2025 was $0.17, a 6% increase from $0.16 in Q3 2024, while diluted income per share was $0.01 compared to a diluted loss per share of $0.00 in Q3 2024 [6][4]. Business Segments - Specialty net revenue increased by 8%, driven by key branded products such as CREXONT® and UNITHROID®, while Affordable Medicines net revenue also rose by 8% due to strong performance in complex products and new launches [3][2]. - AvKARE net revenue surged by 24%, attributed to growth in government label sales [3]. Updated Guidance - The company updated its full-year 2025 guidance, maintaining net revenue expectations at $3.0 billion to $3.1 billion, while adjusting the adjusted EBITDA guidance to $675 million to $685 million, up from the previous range of $665 million to $685 million [8]. - Adjusted diluted EPS guidance was raised to $0.75 to $0.80 from $0.70 to $0.75, and operating cash flow guidance was increased to $300 million to $330 million from $275 million to $305 million [8]. Strategic Developments - The launch of BREKIYA® for migraines and the ongoing evolution of the product portfolio are expected to drive future growth [2]. - The company is entering a significant new product launch cycle in its Affordable Medicines segment, with multiple complex approvals and key launches anticipated [2].
Amneal Pharmaceuticals(AMRX) - 2025 Q2 - Earnings Call Presentation
2025-08-05 12:30
Financial Performance & Growth - Q2 2025 revenue reached $725 million, a 3% increase compared to Q2 2024[5] - Adjusted EBITDA for Q2 2025 was $184 million, up 13% from Q2 2024[5] - Adjusted EPS for Q2 2025 increased by 56% to $025, compared to $016 in Q2 2024[5] - The company is increasing its 2025 adjusted EBITDA guidance range to $665 million - $685 million[5] - Net revenues are projected to be between $30 billion and $31 billion in 2025, representing a 7% to 11% increase[11] Segment Performance - Specialty segment revenue increased by 13% in the first half of 2025[5] - Affordable Medicines segment revenue increased by 4% in the first half of 2025[5] - AvKARE segment revenue increased by 1% in the first half of 2025[5] - AvKARE revenue reached $663 million in 2024, with a 23% compound annual growth rate (CAGR) from 2020 to 2024, and is projected to exceed $900 million by 2027[24] Product & Pipeline Development - CREXONT is on track to achieve peak U S sales of $300 million to $500 million[39] - The company expects to file a Biologics License Application (BLA) for an omalizumab biosimilar (bXOLAIR) in Q4[5] - The company launched 15 new products in the Affordable Medicines portfolio year-to-date[5]
Amneal Reports Second Quarter 2025 Financial Results
GlobeNewswire News Room· 2025-08-05 10:00
Core Insights - Amneal Pharmaceuticals reported a net revenue of $725 million for Q2 2025, reflecting a 3% increase from $702 million in Q2 2024. The company also achieved a GAAP net income of $22 million, up from $6 million in the same quarter last year [1][4][3]. Financial Performance - The adjusted EBITDA for Q2 2025 was $184 million, marking a 13% increase compared to the same period in 2024 [4]. - Diluted income per share rose to $0.07 in Q2 2025 from $0.02 in Q2 2024, while adjusted diluted EPS increased by 56% to $0.25 from $0.16 [5][4]. Revenue Breakdown - Specialty net revenue surged by 23%, driven by key branded products such as CREXONT®, RYTARY®, and UNITHROID® [3]. - Affordable Medicines net revenue saw a 1% increase, attributed to strong performance in the complex product portfolio and new product launches, although this was partially offset by supply timing issues [3]. - AvKARE net revenue decreased by 4%, impacted by lower revenue in the distribution channel despite growth in government label sales [3]. Guidance and Outlook - The company raised its full-year 2025 guidance, maintaining net revenue expectations between $3.0 billion and $3.1 billion, while increasing adjusted EBITDA guidance to $665 million - $685 million from the previous $650 million - $675 million [7][8]. Debt Refinancing - Amneal completed a comprehensive debt refinancing on August 1, 2025, entering into $2.1 billion of new seven-year Term B loans and issuing $600 million in senior secured notes due 2032. This refinancing is expected to yield substantial interest cost savings and extend maturities to 2032 [10][2].
Amneal Reports Certain Preliminary Second Quarter 2025 Financial Results
Globenewswire· 2025-07-21 11:38
Core Insights - Amneal Pharmaceuticals reported preliminary financial results for Q2 2025, indicating robust growth and expectations to meet or exceed full-year guidance [1][3] - The company received FDA approval for Brekiya® autoinjector for migraine treatment and noted strong uptake of CREXONT® [3] - Amneal anticipates a BLA submission for a proposed biosimilar to XOLAIR® in Q4 2025, highlighting a strong pipeline for future growth [3] Financial Performance - Net revenue is projected to be between $720 million and $730 million, reflecting an approximate 3% increase compared to Q2 2024 [7] - Income before income taxes is expected to range from $45 million to $56 million, a significant increase from $20 million in the same period of 2024 [7] - Adjusted EBITDA is projected to be between $180 million and $185 million, marking an approximate 13% increase from Q2 2024 [7] Leverage Metrics - Gross leverage decreased to 3.8x as of June 30, 2025, down from 4.1x as of December 31, 2024 [7] - Net leverage also decreased to 3.7x as of June 30, 2025, compared to 3.9x at the end of 2024, attributed to higher profitability and continued debt reduction [7]
Amneal Pharmaceuticals (AMRX) 2025 Earnings Call Presentation
2025-06-06 09:18
Financial Performance & Growth - Amneal Pharmaceuticals is entering a new era of growth as a global biopharmaceutical company[9] - The company projects net revenues of $3.0 - $3.1 billion for 2025, reflecting a growth of 7% to 11%[11] - Adjusted EBITDA is guided at $650 million - $675 million for 2025, indicating a growth of 4% to 8%[11] - The company's net leverage stands at 3.9x as of Q1 2025, with expectations to reduce it to less than 3x in the coming years[11, 50] Business Diversification & Pipeline - Oral solid generics are decreasing as a percentage of total revenue, from 53% in 2019 to 23%[11] - The pipeline is shifting towards non-oral solids, with 96% of pipeline products being non-oral solids[11, 44] - The company has 3 commercial biosimilars and 5 biosimilars in the pipeline[11] Strategic Initiatives & Product Portfolio - Specialty business revenue reached $449 million in the last twelve months of Q1 2025, growing +11% compared to the prior year period[26] - CREXONT for Parkinson's Disease is expected to achieve $300-500 million in U S peak sales[29] - AvKARE segment is experiencing double-digit growth, aiming for $900 million+ revenue by 2027[16]
Amneal Pharmaceuticals(AMRX) - 2025 Q1 - Earnings Call Presentation
2025-05-02 10:32
Financial Performance & Growth - Q1 2025 revenue reached $695 million, a 5% increase year-over-year[10] - Adjusted EBITDA for Q1 2025 was $170 million, up 12% compared to Q1 2024[10] - Adjusted EPS for Q1 2025 increased by 50% to $0.21[10] - The company affirms its full-year 2025 revenue guidance of $3.0 - $3.1 billion, representing a 7% to 11% growth[59] - Adjusted EBITDA for 2025 is projected to be $650 - $675 million, a 4% to 8% increase[59] Business Segment Performance - Affordable Medicines segment revenue grew by 6% to $415 million in Q1 2025[58] - Specialty segment revenue increased by 3% to $108 million in Q1 2025[58] - AvKARE segment revenue also grew by 6% to $172 million in Q1 2025[58] Key Products & Pipeline - CREXONT® is experiencing strong script growth and expanding coverage, reaching approximately 60%[10] - Eight new products have been launched in 2025, including BORUZUTM, a 505(b)(2) injectable[10] - Two denosumab biosimilar Biologics License Applications (BLAs) have been filed[10] Debt & Leverage - Net leverage stands at 3.9x as of March 31, 2025[17]
Amneal Pharmaceuticals(AMRX) - 2024 Q4 - Earnings Call Presentation
2025-02-28 19:21
Financial Performance & Growth - Amneal reported strong 2024 net revenue of $2.8 billion, a 17% increase year-over-year, and adjusted EBITDA of $627 million, a 12% increase year-over-year[9] - The company achieved broad-based double-digit revenue growth across all three business segments in 2024: Affordable Medicines +15%, Specialty +14%, and AvKARE +25%[9] - Net leverage was reduced to 3.9x, below the expected 4x, and down from 4.8x at the end of 2023[9] - Amneal paid down $182 million in debt over the course of 2024[9] - The company projects 2025 net revenue between $3.0 and $3.1 billion (7% to 11% growth) and adjusted EBITDA between $650 and $675 million (4% to 8% growth)[52] Strategic Initiatives & Portfolio Expansion - Amneal is entering a new chapter of growth in 2025 and beyond, focusing on becoming a global biopharmaceutical company[12, 14] - The company is expanding its biosimilar portfolio from three biosimilars to six biosimilars across eight product presentations expected by 2027[9, 36] - A collaboration with Metsera is in place for developing next-generation obesity therapies (GLP-1s)[9, 31] Segment Performance & Outlook - Affordable Medicines generated $1.685 billion in revenue in 2024 and is projected to have high single-digit growth[22] - Specialty revenue was $446 million in 2024, with a high single-digit growth projection, aiming for $500M+ revenue by 2027[22] - AvKARE achieved $663 million in revenue in 2024 and is projected to have double-digit growth, targeting $900M+ revenue by 2027[22]