Amneal Pharmaceuticals Inc Stock Price, News & Analysis

Amneal Pharmaceuticals (NASDAQ: AMRX) has launched FOCINVEZ™, the first ready-to-use version of fosaprepitant, an anti-nausea agent used in chemotherapy. Unlike other versions, FOCINVEZ does not require reconstitution or dilution, enhancing pharmacy efficiency. It's approved for adults and children over 6 months for preventing nausea and vomiting in highly and moderately emetogenic chemotherapy. The product has a unique CMS reimbursement code J1434 and reported U.S. sales of $36 million over the past year. Adverse effects include fatigue, diarrhea, and neutropenia. This is Amneal’s second ready-to-use injectable in 2024, marking growth in their injectables portfolio.

Amneal Pharmaceuticals has expanded its biosimilar portfolio to include omalizumab, a biosimilar referencing XOLAIR®. Omalizumab is used to treat chronic conditions like severe allergic asthma and chronic urticaria. Developed by Kashiv BioSciences, this biosimilar is currently in a Phase III clinical trial initiated in Q3 2023. With this addition, Amneal's biosimilar portfolio now includes eight products, covering a new therapeutic area beyond oncology. The U.S. annual sales for XOLAIR® reached approximately $3.2 billion as of April 2024. Financial terms were not disclosed, but the associated costs are accounted for in Amneal's guidance.

Kashiv BioSciences has entered into an exclusive licensing agreement with Amneal Pharmaceuticals for the U.S. commercialization of ADL018, a proposed biosimilar to XOLAIR® (omalizumab).

ADL018 is currently in Phase III clinical trials, which began in Q3 2023. Omalizumab, a monoclonal antibody targeting IgE, is used to treat conditions like severe allergic asthma and chronic rhinosinusitis with nasal polyps.

This collaboration builds on the successful U.S. biosimilar partnership between the two companies for oncology products RELEUKO® and FYLNETRA®.

Annual U.S. sales for XOLAIR® were approximately $3.2 billion as of April 2024. Financial terms of the agreement were not disclosed.

Amneal Pharmaceuticals (Nasdaq: AMRX) has released its fourth Environmental, Social, and Governance (ESG) Report for 2023. The report details the company's progress in environmental sustainability, human capital management, and corporate governance. Key achievements include the launch of 39 new generics and injectable products, entering the Indian market, participating in the Association of Accessible Medicines (AAM) and the Biosimilars Forum. The company has also conducted its first Materiality Assessment to identify ESG risks and opportunities. Amneal has implemented greenhouse gas accounting software and developed sustainability-focused inventory management plans. The company aims to improve gender diversity and has expanded its Employee Resource Group (ERG) program. Amneal emphasizes good governance with a robust Corporate Compliance Program.

Amneal Pharmaceuticals (Nasdaq: AMRX) announced the addition of six new injectable therapies in Q2 2024, expanding its US market portfolio to over 40 products. This move aims to address chronic shortages of critical injectables, especially in oncology. Notably, three of these new products are listed on the American Society of Health System Pharmacists (ASHP) drug shortage list, increasing Amneal's total ASHP-listed injectables to 13. The new products include PEMRYDI RTU® (vial), Atropine sulfate (pre-filled syringe), Docetaxel (injection), Foscarnet (IV bag), Methylprednisolone acetate (multi-dose vial), and Calcium gluconate (vial). The company has tripled its production capacity to 60 million units across four facilities and aims to introduce 60 injectables by 2025, including branded oncology products to enhance pharmacy efficiency.

Amneal Pharmaceuticals (Nasdaq: AMRX) announced that its Co-CEO, Chirag Patel, and CFO, Tasos Konidaris, will participate in the 2024 Jefferies Healthcare Conference on June 5, 2024. Chirag Patel is scheduled to present at 1:30 PM EST. A live webcast of the presentation will be available on the company's website, with a replay accessible after the event.

Amneal Pharmaceuticals (Nasdaq: AMRX) has started supplying its over-the-counter (OTC) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, 4mg, to U.S. retail pharmacies and the State of California. Approved by the FDA in April 2024, this generic equivalent to OTC NARCAN® HCI Nasal Spray is now available for direct distribution nationwide. The company has a distribution agreement with California under the CalRx® Naloxone Access Initiative and aims to produce approximately ten million two-packs annually at its New Jersey facility starting in 2025. Amneal is also engaging with other states and municipalities to expand access to this life-saving medication amid the ongoing opioid epidemic.

Amneal Pharmaceuticals, Inc. reported a Q1 2024 net revenue of $659 million, with a GAAP net loss of $92 million and diluted loss per share of $0.30. Adjusted EBITDA was $152 million with adjusted diluted EPS of $0.14. The company settled a nationwide opioids case and affirmed its 2024 full-year guidance.