BRIDGEWATER, N.J. - Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) has announced the launch of its generic Over the Counter (OTC) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg, following the U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA). This product is a generic equivalent to the existing OTC NARCAN® Nasal Spray, which is used to counteract opioid overdoses.
The company's Co-Chief Executive Officers, Chirag and Chintu Patel, expressed their commitment to combating the opioid crisis by enhancing access to naloxone, a life-saving medication, at an affordable price. They emphasized the importance of making the emergency treatment more readily available to potentially save lives and reduce the impact of drug overdoses on families and communities.
Opioid-related overdoses are a major public health concern, with synthetic opioids like fentanyl being a leading cause of drug overdose fatalities, especially among individuals under the age of 50. In 2022, over two-thirds of drug overdose deaths involved synthetic opioids, and in nearly half of these cases, another person was present and could have intervened.
Amneal's Naloxone HCI Nasal Spray is now available and is manufactured in the United States. It is designed to rapidly reverse opioid overdose effects by binding to opioid receptors and can restore normal breathing within two to three minutes. The product has the same active ingredient and dosage as NARCAN® Nasal Spray, 4 mg, and can be safely used even if opioids are not present.
According to data from IQVIA®, the U.S. annual commercial sales for NARCAN® Naloxone HCI Nasal Spray 4mg for the 12 months ending February 2024 amounted to $266 million. Additionally, substantial volumes of the product are acquired directly by U.S. states and municipalities.
Amneal Pharmaceuticals is a global company that develops, manufactures, and distributes a diverse portfolio of over 270 pharmaceutical products, primarily within the United States. The company is focused on expanding across various product categories and therapeutic areas, including injectables and biosimilars, and has a growing portfolio of branded pharmaceuticals.
The information reported is based on a press release statement from Amneal Pharmaceuticals, Inc.
InvestingPro Insights
As Amneal Pharmaceuticals (NASDAQ:AMRX) forges ahead with its strategic launch of the generic Naloxone HCI Nasal Spray, a closer look at the company's financial metrics reveals a dynamic picture. With a market capitalization of $1.67 billion USD, Amneal is positioned as a noteworthy player in the pharmaceutical industry.
Despite not being profitable over the last twelve months, analysts are optimistic, predicting that the company will turn a profit this year. This anticipation is rooted in a strong free cash flow yield, as suggested by the company's valuation.
InvestingPro data shows an 8.2% revenue growth over the last twelve months as of Q4 2023, indicating a steady upward trajectory in sales. This growth is further underscored by a robust gross profit margin of 36.09% in the same period.
Still, the company's P/E ratio stands at a negative 11.35, reflecting the market's current hesitation due to past unprofitability, but it's important to note that the adjusted P/E ratio for the last twelve months is 47.75, which hints at an expected turnaround in earnings.
Investors eyeing Amneal's stock will also consider the "InvestingPro Tips" which highlight that the company has experienced a significant price uptick over the last six months, boasting a 35.0% return. This performance is impressive, especially when paired with a 208.57% return over the last year, showcasing the stock's strong momentum.
Yet, it is important to acknowledge that two analysts have revised their earnings estimates downwards for the upcoming period, which could indicate potential headwinds.
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