[Amneal Preliminary Second Quarter 2025 Financial Results](index=1&type=section&id=Amneal%20Preliminary%20Second%20Quarter%202025%20Financial%20Results) This report presents Amneal's strong preliminary Q2 2025 financial results, non-GAAP reconciliations, and associated risk factors [Financial and Operational Highlights](index=1&type=section&id=Unaudited%20Preliminary%20Financial%20Results%20for%20the%20Second%20Quarter%20Ended%20June%2030%2C%202025) The company reports strong preliminary Q2 2025 results, driven by revenue growth, operational milestones, and significant deleveraging - Key operational updates include the U.S. FDA approval of Brekiya® autoinjector, strong commercial uptake of CREXONT®, and an expected BLA submission for a XOLAIR® biosimilar in Q4 2025[3](index=3&type=chunk) Preliminary Financial Highlights for Q2 2025 | Metric | Q2 2025 Preliminary Range | Change vs. Q2 2024 | | :--- | :--- | :--- | | Net Revenue | $720M - $730M | ~3% Increase | | Income before income taxes | $45M - $56M | Increase from $20M | | Adjusted EBITDA | $180M - $185M | ~13% Increase | | Gross Leverage | 3.8x (as of June 30, 2025) | Decrease from 4.1x (Dec 31, 2024) | | Net Leverage | 3.7x (as of June 30, 2025) | Decrease from 3.9x (Dec 31, 2024) | [Non-GAAP Financial Measures and Reconciliations](index=2&type=section&id=Non-GAAP%20Financial%20Measures) This section defines and reconciles non-GAAP measures like Adjusted EBITDA and leverage ratios to their comparable GAAP figures [Definition of Non-GAAP Measures](index=2&type=section&id=Definition%20of%20Non-GAAP%20Measures) The company defines non-GAAP metrics like Adjusted EBITDA and leverage ratios to assess core operational performance - The company provides non-GAAP financial measures, including EBITDA, adjusted EBITDA, gross leverage, and net leverage, as supplemental performance indicators[11](index=11&type=chunk) - **EBITDA** is defined as income before income taxes, excluding interest expense, depreciation, and amortization; **Adjusted EBITDA** further excludes items like stock-based compensation and restructuring charges; **Gross Leverage** is gross debt divided by LTM Adjusted EBITDA; and **Net Leverage** is net debt divided by LTM Adjusted EBITDA[12](index=12&type=chunk)[13](index=13&type=chunk) [Reconciliation of Income Before Income Taxes to Adjusted EBITDA (Quarterly)](index=4&type=section&id=Reconciliation%20of%20Income%20Before%20Income%20Taxes%20to%20EBITDA%20and%20Adjusted%20EBITDA) Preliminary Q2 2025 Adjusted EBITDA is projected at $180M-$185M, a significant increase from Q2 2024 Q2 Adjusted EBITDA Reconciliation (Preliminary 2025 vs. 2024) | (in thousands) | Q2 2025 (Preliminary Range) | Q2 2024 (Actual) | | :--- | :--- | :--- | | Income before income taxes | $45,000 - $56,000 | $20,405 | | EBITDA (Non-GAAP) | $172,000 - $179,000 | $141,696 | | **Adjusted EBITDA (Non-GAAP)** | **$180,000 - $185,000** | **$162,211** | [Calculation of Net Debt and Net Leverage](index=8&type=section&id=Calculation%20of%20Net%20Debt%20and%20Net%20Leverage) The company reduced its Gross Leverage to 3.8x and Net Leverage to 3.7x, reflecting improved profitability and debt reduction Leverage Calculation Comparison | Metric | June 30, 2025 (Preliminary) | December 31, 2024 | | :--- | :--- | :--- | | Gross debt | $2,553,460 thousand | $2,584,835 thousand | | Net debt (Non-GAAP) | $2,481,916 thousand | $2,474,283 thousand | | LTM Adjusted EBITDA | $665,358 thousand | $627,442 thousand | | **Gross leverage (Non-GAAP)** | **3.8x** | **4.1x** | | **Net leverage (Non-GAAP)** | **3.7x** | **3.9x** | [Reconciliation of Adjusted EBITDA (Last Twelve Months)](index=10&type=section&id=Reconciliation%20of%20Income%20(Loss)%20Before%20Income%20Taxes%20to%20EBITDA%20and%20Adjusted%20EBITDA%20(LTM)) Preliminary LTM Adjusted EBITDA reached $665.4 million as of June 30, 2025, used for calculating leverage ratios LTM Adjusted EBITDA Calculation (as of June 30, 2025) | Period | Adjusted EBITDA (Non-GAAP) (in thousands) | | :--- | :--- | | Q3 2024 | $157,623 | | Q4 2024 | $155,257 | | Q1 2025 | $169,978 | | Q2 2025 (Preliminary) | $182,500 | | **LTM Total** | **$665,358** | Full Year 2024 Adjusted EBITDA Reconciliation | (in thousands) | Year Ended Dec 31, 2024 | | :--- | :--- | | Loss before income taxes | $(55,013) | | EBITDA (Non-GAAP) | $439,773 | | **Adjusted EBITDA (Non-GAAP)** | **$627,442** | [Cautionary Statements and Risk Factors](index=1&type=section&id=Cautionary%20Statement%20on%20Forward-Looking%20Statements) This section outlines forward-looking statements and key risks that could impact financial results - The preliminary financial results are forward-looking statements and are subject to change pending completion of financial close procedures[4](index=4&type=chunk)[6](index=6&type=chunk) - The company's performance is subject to numerous risks, including competition, customer consolidation, supply chain dependencies, and substantial indebtedness[10](index=10&type=chunk)

Core Viewpoint - Amneal Pharmaceuticals, Inc. is seeking to raise $1.800 billion through new seven-year term B loans and $750 million through senior secured notes to refinance existing debts and manage related expenses [1][2]. Group 1: Financing Details - The net proceeds from the new term B loans and the notes will be used to refinance existing term B loans in full, repay part of the amounts borrowed under the ABL facility, and cover related fees and expenses [2]. - The notes will be guaranteed on a senior secured basis by the same subsidiaries that will guarantee the Term Loan Facility, and will not be guaranteed by Amneal itself [3]. - The notes will have a first-priority lien on collateral, excluding ABL priority collateral, and a second-priority lien on ABL priority collateral [3]. Group 2: Regulatory and Market Considerations - The proposed transactions are subject to market conditions and other factors, with no assurance on the completion or terms of the transactions [4]. - The notes will not be registered under the Securities Act of 1933 and will only be offered to qualified institutional buyers and non-U.S. persons [5]. Group 3: Company Overview - Amneal is a global biopharmaceutical company headquartered in Bridgewater, NJ, with a diverse portfolio of over 280 pharmaceuticals, primarily in the U.S. [7]. - The company is expanding its Affordable Medicines segment across various complex product categories and therapeutic areas, including injectables and biosimilars [7].

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]

Core Viewpoint - Amneal Pharmaceuticals, Inc. will release its second quarter 2025 financial results on August 5, 2025, prior to market open, and will host an audio webcast at 8:30 a.m. ET [1] Company Overview - Amneal Pharmaceuticals, Inc. is a global biopharmaceutical company headquartered in Bridgewater, NJ, with a diverse portfolio of over 280 pharmaceuticals primarily in the United States [3] - The company operates in multiple segments, including Affordable Medicines, which focuses on complex product categories and therapeutic areas such as injectables and biosimilars, and Specialty, which has a growing portfolio of branded pharmaceuticals targeting central nervous system and endocrine disorders [3] - Through its AvKARE segment, Amneal distributes pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets [3] Investor Relations - The financial results and live webcast will be accessible through the Investor Relations section of the company's website [2] - Individuals can register for the webcast and access the call through a conference line with specific dialing instructions provided [2]

Company Performance - Amneal Pharmaceuticals (AMRX) has shown a year-to-date return of 2.7%, outperforming the average loss of 4.1% in the Medical group [4] - The Zacks Consensus Estimate for AMRX's full-year earnings has increased by 4.9% in the past quarter, indicating improved analyst sentiment [4] - Amneal Pharmaceuticals holds a Zacks Rank of 2 (Buy), suggesting a positive earnings outlook [3] Industry Context - Amneal Pharmaceuticals is part of the Medical - Drugs industry, which consists of 163 stocks and is currently ranked 85 in the Zacks Industry Rank [6] - The Medical - Drugs industry has gained an average of 0.6% year-to-date, indicating that AMRX is performing better than its industry peers [6] - In comparison, AtriCure (ATRC), another outperforming stock, belongs to the Medical - Products industry, which has seen a 6.7% increase this year and is ranked 155 [6]

Core Insights - Amneal Pharmaceuticals has announced positive topline results from a clinical trial for ADL-018, a proposed biosimilar to XOLAIR (omalizumab), which is expected to be a significant growth driver for the company in the U.S. biosimilar market valued at $3.9 billion [1][4] - The Biologics License Application (BLA) for ADL-018 is anticipated to be filed with the FDA in Q4 2025, with Amneal holding exclusive U.S. commercialization rights pending regulatory approval [3] Group 1: Clinical Trial Results - The confirmatory clinical trial for ADL-018 was a randomized, double-blind, multicenter study that evaluated its efficacy, safety, and immunogenicity compared to XOLAIR in patients with Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU) [1][2] - The study met its primary and secondary endpoints, demonstrating equivalence in therapeutic outcomes and comparable safety profiles between ADL-018 and XOLAIR [2] Group 2: Market Context - Omalizumab, the reference product, is indicated for severe allergic asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria, with U.S. annual sales reaching approximately $3.9 billion for the 12 months ending April 2025 [4] - The successful development of ADL-018 is part of Amneal's broader strategy to commercialize six biosimilars across eight product presentations by 2027 [3] Group 3: Company Background - Amneal Pharmaceuticals is a global biopharmaceutical company based in Bridgewater, NJ, with a diverse portfolio of over 280 pharmaceuticals, focusing on both affordable medicines and specialty branded pharmaceuticals [5] - Kashiv BioSciences, the developer of ADL-018, is a vertically integrated biopharmaceutical company with a focus on delivering cost-effective, high-quality therapies [6][7]

Core Viewpoint - Amneal Pharmaceuticals has received FDA approval for prednisolone acetate ophthalmic suspension, a significant addition to its Affordable Medicines portfolio, with a planned launch in Q3 2025 [1][3]. Group 1: Product Details - Prednisolone acetate ophthalmic suspension, USP 1%, is a sterile topical anti-inflammatory agent indicated for treating steroid-responsive ocular inflammation [2]. - The product is a complex formulation that demonstrates the company's R&D capabilities and manufacturing strength [3]. Group 2: Market Insights - According to IQVIA, the U.S. annual sales for prednisolone acetate ophthalmic suspension were approximately $201 million for the 12 months ending April 2025 [4]. Group 3: Company Overview - Amneal Pharmaceuticals, Inc. is a global biopharmaceutical company based in Bridgewater, NJ, with a diverse portfolio of over 280 pharmaceuticals, primarily in the U.S. market [5]. - The company is expanding its Affordable Medicines segment across various complex product categories, including injectables and biosimilars [5].

Amneal Pharmaceuticals (AMRX) FY Conference June 10, 2025 10:40 AM ET Speaker0 Okay. Great. Well, thank you everyone for joining us today. My name is Matt Delatorre, and I'm the generics pharma analyst here at GS. And we're we're very pleased to have Amneal Pharmaceuticals with us for this session with Sharag Patel, cofounder and co CEO, and Tassos Konidaris, the chief financial officer. Great. So maybe maybe just to get started, you know, how about just level set us on where Amneal is headed from kind of a ...

Jefferies Healthcare Conference Company Presentation June 5, 2025 1 Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management's intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated ...

Amneal Pharmaceuticals (AMRX) 2025 Conference June 05, 2025 09:20 AM ET Speaker0 To get an on time start. It's my pleasure. I am Jonas Schirleff from the Healthcare Investment Banking team here at Jefferies. Today we will be hearing from Chirag Entasos from the Amneal Pharmaceuticals team and I will hand it over to you. Thank you very much. Speaker1 Thank you. Thank you. Good morning everyone. Great to see you. Beautiful summer day and hopefully you guys get to go out and walk around and I think the Canadia ...