Amneal Begins Supplying Over-the-Counter Naloxone Hydrochloride Nasal Spray to U.S. Retail Pharmacies and the State of California

Rhea-AI Summary

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.

Positive

• FDA approval for Naloxone HCI Nasal Spray in April 2024.
• Commencement of supplies to U.S. retail pharmacies and the State of California.
• Distribution agreement with California under the CalRx® Naloxone Access Initiative.
• Plans to produce ten million two-packs annually starting in 2025.
• Engagement with other states and municipalities to expand access.
• Amneal's leadership in complex generics and manufacturing capabilities.

Negative

• Production capacity constraints until 2025.
• Potential risks related to scaling up manufacturing operations.
• Dependence on state and municipal agreements for distribution expansion.

Insights

Financial Analyst

Amneal Pharmaceuticals has announced the commencement of distribution for its over-the-counter (OTC) Naloxone Hydrochloride Nasal Spray, which is a generic equivalent to NARCAN®. This development has significant implications for the company's financial outlook. First, by tapping into the OTC market, Amneal expands its revenue streams, especially given the ongoing opioid epidemic's demand for such life-saving treatments. The agreement with California also indicates a reliable source of revenue since state contracts tend to be long-term and stable. Moreover, if Amneal can successfully secure additional agreements with other states and municipalities, the revenue potential increases substantially.

It's important to note that Amneal projects to produce ten million two-packs annually by 2025 at its New Jersey facility. This production capability suggests that Amneal is making substantial investments in scaling up its operations, which should reassure investors about the company's commitment to meeting market demand.

Medical Research Analyst

The introduction of OTC Naloxone Hydrochloride Nasal Spray by Amneal signifies a pivotal moment in public health, addressing the urgent need for accessible opioid overdose treatments. The FDA approval in April 2024 underscores the product's safety and efficacy, important for gaining consumer and healthcare provider trust. What sets this product apart is its availability without a prescription, broadening access significantly as individuals can now procure it directly from retail pharmacies.

The partnership with California through the CalRx® Naloxone Access Initiative is particularly noteworthy. This state-level endorsement not only validates the product's importance but also highlights the growing recognition of OTC naloxone as a vital tool in combating the opioid crisis. The involvement of state governments could also mean increased public awareness and education efforts, further boosting the product's uptake.

Market Research Analyst

From a market perspective, Amneal's entry into the OTC naloxone market is a strategic move with promising growth potential. The opioid crisis remains a significant public health issue and there is a high demand for effective and accessible overdose treatments. The product's approval by the FDA and its alignment with a major public health initiative in California positions Amneal well against competitors.

The potential for broader state-level agreements indicates a scalable market opportunity. Retail investors should consider that while the initial distribution agreement with California is an excellent start, the ongoing engagements with other states and municipalities could substantially broaden the market base, leading to increased sales volume and market share. Additionally, Amneal's manufacturing capacity in New Jersey reflects a solid foundation to meet future demand, mitigating supply chain risks that often plague pharmaceutical companies.

Significantly expanding access to affordable, life-saving opioid overdose rescue medicine

Entered distribution agreement with California; actively engaging with other states and municipalities to expand access

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has begun supplying its over-the-counter (OTC) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg to U.S. retail pharmacies and the State of California. The product is now available for direct distribution to states and municipalities across the U.S.

The U.S. Food and Drug Administration approved Amneal’s Naloxone HCI Nasal Spray in April 2024. Amneal’s Naloxone HCI Nasal Spray is a generic equivalent to OTC NARCAN^® HCI Nasal Spray, a medication widely used to help treat opioid drug overdoses. The Company also entered into a distribution agreement with California to provide Naloxone HCI Nasal Spray through the CalRx^® Naloxone Access Initiative. Amneal expects to have capacity to produce approximately ten million two-packs annually at its New Jersey manufacturing facility, starting in 2025.

“Amneal is an industry leader in complex generics with the ability to develop, manufacture and commercialize high-quality medicines that are affordable and accessible. The widespread availability of OTC naloxone will be a critical tool in the fight against the ongoing opioid epidemic. Amneal is proud to be part of the solution,” said Andy Boyer, Executive Vice President, Chief Commercial Officer – Generics.

“We are pleased to partner with the State of California on a long-term distribution agreement to make OTC naloxone available to thousands of communities and millions of people. We are actively engaging with other states and municipalities to expand access to this important life-saving product, which is proudly made in America in one of our New Jersey facilities,” said Maryll Toufanian, SVP, Regulatory Strategy and Government Affairs.

To learn more about Amneal’s Naloxone HCl Nasal Spray, please visit https://amnealnaloxone.com/.

About Naloxone Nasal Spray

Naloxone Hydrochloride (Naloxone HCI) Nasal Spray is designed to rapidly reverse the effects of a life-threatening opioid emergency by binding to opioid receptors in the brain and blocking the effects of opioids. It can restore normal breathing within two to three minutes in a person whose breath has slowed, or even stopped, as a result of an overdose from opioids including heroin, fentanyl and prescription opioid medications. Amneal’s Naloxone HCI Nasal Spray contains the same active ingredient and dose as NARCAN^® Naloxone HCI Nasal Spray, 4 mg. It is available over-the-counter and is easy to carry, and it can be safely used even if opioids are not present in the patient.

NARCAN^® is a registered trademark of Emergent Operations Ireland Limited.

When using this product some people may experience symptoms when they wake up, such as shaking, sweating, nausea or feeling angry. This is to be expected.

About Amneal

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.

Cautionary Statement on Forward-Looking Statements

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 operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements.

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.

Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A common stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240522229390/en/

Investor and Media Contact

Anthony DiMeo

VP, Investor Relations & Media

anthony.dimeo@amneal.com

Government Contact

Maryll Toufanian

SVP, Regulatory Strategy and Government Affairs

maryll.toufanian@amneal.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What product did Amneal Pharmaceuticals start supplying to U.S. retail pharmacies?

Amneal Pharmaceuticals started supplying its over-the-counter Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, 4mg.

When did the FDA approve Amneal's Naloxone HCI Nasal Spray?

The FDA approved Amneal's Naloxone HCI Nasal Spray in April 2024.

What is the stock symbol for Amneal Pharmaceuticals?

The stock symbol for Amneal Pharmaceuticals is AMRX.

What initiative is associated with Amneal's distribution agreement in California?

Amneal's distribution agreement in California is associated with the CalRx® Naloxone Access Initiative.

What is the annual production goal for Amneal's Naloxone HCI Nasal Spray starting in 2025?

Amneal aims to produce approximately ten million two-packs of Naloxone HCI Nasal Spray annually starting in 2025.

Is Amneal engaging with other states to distribute their Naloxone HCI Nasal Spray?

Yes, Amneal is actively engaging with other states and municipalities to expand access to their Naloxone HCI Nasal Spray.