BRIDGEWATER, N.J. - Amneal Pharmaceuticals, Inc. (NASDAQ: NASDAQ:AMRX) announced today the launch of FOCINVEZ™, a new fosaprepitant injectable drug designed to prevent nausea and vomiting in chemotherapy patients. This ready-to-use (RTU) product is unique in that it does not contain Polysorbate 80, a substance commonly found in similar medications, and does not require any reconstitution or dilution before use.
FOCINVEZ is indicated for use in adults and children over the age of six months and is to be administered in combination with other antiemetic agents. It is designed to combat the side effects of both highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin, and moderately emetogenic chemotherapy (MEC).
Sean McGowan, Vice President of Biosimilars and Branded Oncology at Amneal, emphasized the significance of this launch, stating that it represents a new growth direction for the company's injectable portfolio. This is the second RTU injectable Amneal has introduced in 2024, with both aiming to enhance efficiency in hospitals and oncology clinics.
The Centers for Medicare & Medicaid Services has assigned FOCINVEZ a unique J-Code (J1434) to streamline the reimbursement process. Adverse effects associated with the drug include fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infections, and extremity pain, according to the company's press release.
Amneal, a global pharmaceutical company based in Bridgewater, New Jersey, has reported U.S. annual sales of approximately $36 million for fosaprepitant in the twelve months ending April 2024, according to data from IQVIA®.
In other recent news, Amneal Pharmaceuticals has reported robust growth in Q1 2024, with revenues soaring by 18% year-over-year to reach a record $659 million. This surge in revenue was propelled by double-digit growth across all segments, including Generics, Specialty, and AvKARE. The company's strategic initiatives, such as international expansion and addressing drug shortages, have prepared it for sustained growth. Amneal's innovation is highlighted by its strong pipeline, with over 30 product launches planned for 2024 and a substantial presence in the biosimilars market, where it expects to generate revenues exceeding $125 million.
The company's adjusted EBITDA for Q1 increased by 31% to $152 million, with the full-year outlook targeting the upper end of $580 million to $620 million. For the full year, Amneal is aiming for total net revenue between $2.550 billion and $2.650 billion. The company plans to launch one to two specialty products annually, emphasizing R&D.
In other recent developments, six key products have received approval, and the company is optimistic about good market penetration for its biosimilars Prolia and XGEVA, expected to launch in 2026. However, the timing of new product launches and approvals, which are significant growth drivers, is not entirely within the company's control. The company is also exploring strategic options for AvKARE, indicating a potential transaction if the right price is offered.
InvestingPro Insights
As Amneal Pharmaceuticals (NASDAQ: AMRX) continues to expand its portfolio with the launch of FOCINVEZ™, the company's financial health and market performance remain a point of interest for investors. With a robust market capitalization of $2.11 billion, Amneal shows a significant presence in the pharmaceutical industry.
An InvestingPro Tip highlights that analysts predict Amneal will be profitable this year, a notable turnaround considering the company was not profitable over the last twelve months. This forecast aligns with the company's strategic focus on growth through new product launches such as FOCINVEZ™.
Investors may also find the company's strong performance over the last year compelling; with a 117.89% one-year price total return, Amneal has demonstrated its ability to deliver substantial returns. Additionally, the stock is trading near its 52-week high, at 94.41% of the peak price, showcasing investor confidence in the company's trajectory.
In terms of financial metrics, Amneal's revenue growth has been impressive, with a 9.82% increase over the last twelve months as of Q1 2024. This growth is further accentuated by a quarterly revenue growth of 18.23% in Q1 2024, reflecting the company's strong performance at the start of the year.
For readers interested in a deeper analysis and more InvestingPro Tips, they can explore further insights on Amneal's performance and projections at https://www.investing.com/pro/AMRX. There are 7 additional InvestingPro Tips available, providing a comprehensive view of the company's financial landscape. To access these insights, readers can use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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