Amneal Pharmaceuticals Inc Stock Price, News & Analysis

Amneal Pharmaceuticals (AMRX) and Metsera have announced a strategic collaboration to develop and supply next-generation medicines for obesity and metabolic diseases. Key points include:

1. Amneal will construct new manufacturing facilities in India for peptide synthesis and sterile fill-finish, with a net cost of $150-200 million over 4-5 years.

2. Metsera is advancing a portfolio of therapies, including ultra-long acting injectable and oral nutrient stimulated hormone (NuSH) analogs.

3. Amneal will be Metsera's preferred supply partner for developed markets and gain commercialization rights in select emerging markets.

4. The collaboration aims to deliver weight loss medicines at scale, leveraging Amneal's manufacturing expertise and Metsera's innovative drug portfolio.

Amneal Pharmaceuticals (Nasdaq: AMRX) has launched CREXONT® (carbidopa and levodopa) extended-release capsules for Parkinson's disease treatment. CREXONT® is now available in U.S. pharmacies nationwide. The novel formulation combines immediate-release granules and extended-release pellets, providing longer duration of "Good On" time with less frequent dosing compared to immediate-release CD/LD.

Amneal is implementing a comprehensive education program and extensive services to support healthcare providers and patients. Eligible commercially insured patients may qualify for a $25 copay through the CREXONT Savings Program. The company will also offer patient assistance and prior authorization support.

Amneal will present CREXONT at the International Congress of Parkinson's Disease and Movement Disorders on Sept. 27 – Oct. 1, 2024, including a launch symposium and scientific presentations.

Amneal Pharmaceuticals (AMRX) and Shilpa Medicare have received FDA approval for BORUZU™, the first ready-to-use version of bortezomib for subcutaneous administration. This oncology treatment is used for multiple myeloma and mantle cell lymphoma. BORUZU reduces compounding preparation steps, offering a more efficient solution for clinicians. It's Amneal's fourth 505(b)(2) injectable approval in 2024. The product is expected to launch with a unique J-code in Q2 2025. BORUZU references the branded product Velcade®, but offers a ready-to-use formulation. According to IQVIA®, U.S. annual sales for bortezomib were approximately $96 million for the 12 months ended December 2023.

Amneal Pharmaceuticals (Nasdaq: AMRX) has received FDA approval for Propofol Injectable Emulsion USP in single-dose vials. Propofol, an essential surgical anesthetic, is currently on the ASHP drug shortages list. Amneal plans to manufacture the product in-house on a dedicated line to ensure consistent supply, with a launch expected in Q4 2024.

The approval covers three dosage strengths: 200 mg/20 mL, 500 mg/50 mL, and 1,000 mg/100 mL. This complex emulsion injectable expands Amneal's portfolio and addresses supply chain constraints. According to IQVIA®, U.S. annual sales for propofol were approximately $314 million for the 12 months ended June 2024.

Amneal Pharmaceuticals (AMRX) reported strong Q2 2024 results, with net revenue of $702 million, up 17% year-over-year. The company achieved GAAP net income of $6 million and diluted income per share of $0.02. Adjusted EBITDA increased 11% to $162 million, while adjusted diluted EPS was $0.16. Generics revenue grew 14%, Specialty revenue increased 7%, and AvKARE revenue surged 33%.

Based on these results, Amneal has raised its full-year 2024 guidance. The company now expects net revenue between $2.70-$2.80 billion, adjusted EBITDA of $610-$630 million, and adjusted diluted EPS of $0.57-$0.63. The recent FDA approval of CREXONT® for Parkinson's disease is seen as a new long-term growth driver.

Amneal Pharmaceuticals (Nasdaq: AMRX) has received FDA approval for CREXONT® (carbidopa and levodopa extended-release capsules) to treat Parkinson's disease. This novel formulation combines immediate-release granules and extended-release pellets, providing more 'Good On' time with less frequent dosing compared to immediate-release CD/LD. Key benefits include:

1. 0.5 hours additional 'Good On' time per day
2. Average of 3 doses daily vs. 5 for IR CD/LD
3. 1.6 hours additional 'Good On' time per dose
4. Safety profile consistent with IR CD/LD

Amneal plans to launch CREXONT commercially in September 2024, targeting the approximately one million people with Parkinson's disease in the U.S.

Amneal Pharmaceuticals (Nasdaq: AMRX) has received FDA approval for its potassium phosphates in 0.9% sodium chloride injection intravenous (IV) ready-to-use bags. This is the first preservative-free presentation of potassium phosphates in a single-dose IV infusion bag. It's Amneal's third 505(b)(2) injectable launch in 2024, following PEMRYDI RTU® and FOCINVEZ®. The product is indicated to correct hypophosphatemia in adults and pediatric patients weighing 40 kg or more when oral or enteral replacement isn't possible. It's latex-free and can be stored at room temperature. Amneal plans to launch the product in Q3 2024, expanding its injectables portfolio with this differentiated offering for hospitals.

Amneal Pharmaceuticals (NASDAQ: AMRX) will release its second quarter 2024 financial results on August 9, 2024, before market open.

The company will host a conference call and live webcast at 8:30 a.m. Eastern Time to discuss the results.

Details for accessing the call and webcast are available on the company's Investor Relations website.

Participants need to register for the conference call to receive dial-in details and a unique PIN.

A replay of the call will be accessible for seven days following the event.

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.