ANI Pharmaceuticals Launches Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution

Rhea-AI Summary

ANI Pharmaceuticals (Nasdaq: ANIP) has launched Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution, 6.25 mg/15 mg per 5 mL. This marks the company's 14th new product launch in 2024, contributing to strong growth in its Generics business. The timing of the launch is strategic, coinciding with the upcoming cough and cold season.

According to IQVIA data from July 2024, the U.S. annual sales for this oral solution total approximately $42.6 million. This launch aligns with ANI's strategy to expand its product portfolio and capitalize on market opportunities in the pharmaceutical sector.

Positive

• Launch of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution
• 14th new product launch in 2024
• Strong growth reported in Generics business
• Strategic timing before cough and cold season
• Product has $42.6 million annual sales potential in the U.S. market

Negative

• None.

Insights

Financial Analyst

The launch of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution represents a strategic move for ANI Pharmaceuticals. With a $42.6 million annual market size, this product has the potential to significantly boost ANI's revenue stream, especially considering its timely release before the cough and cold season.

Being the 14th new product launch this year demonstrates ANI's aggressive growth strategy in the generics market. This consistent pipeline execution could lead to improved market share and financial performance. However, investors should consider factors such as market competition, pricing pressures and the company's ability to capture a substantial portion of the market share to fully assess the impact on ANI's financials.

Market Research Analyst

The timing of this product launch is particularly strategic, aligning with the upcoming cough and cold season. This could potentially lead to rapid market penetration and increased sales in the short term. The $42.6 million market size, while not enormous, represents a solid opportunity for ANI to expand its footprint in the generics space.

It's worth noting that ANI's consistent product launches (14 this year) indicate a robust R&D pipeline and efficient regulatory approval process. This agility in bringing new products to market could be a key differentiator in the competitive generics landscape, potentially leading to sustained growth and improved market position for ANI Pharmaceuticals.

PRINCETON, N.J., Sept. 13, 2024 (GLOBE NEWSWIRE) --  ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution, 6.25 mg/15 mg per 5 mL.

"The launch of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution just prior to the onset of cough and cold season is especially timely. With our 14^th new product launch this year, we continue to drive strong growth in our Generics business,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

U.S. annual sales for Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution total approximately $42.6 million, based on July 2024 moving annual total (MAT) IQVIA data.

About ANI Pharmaceuticals, Inc.

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. The Company is focused on delivering sustainable growth by scaling up its Rare Disease business through its lead asset Purified Cortrophin® Gel, strengthening its Generics business with enhanced research and development capabilities, delivering innovation in Established Brands, and leveraging its U.S. based manufacturing footprint. For more information, visit www.anipharmaceuticals.com.

Forward-Looking Statements

To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the commercialization and potential sales of the product and any additional product launches from the Company’s generic pipeline, other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates.

Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to: our ability to continue to achieve commercial success with Cortrophin Gel, our first rare disease pharmaceutical product, including expanding the market and gaining market share, our business, financial condition, and results of operations will be negatively impacted; the ability of our approved products, including Cortrophin Gel, to achieve commercialization at levels of market acceptance that will continue to allow us to achieve profitability; our ability to complete or achieve any, or all of the intended benefits of acquisitions and investments, including the acquisition of Alimera, in a timely manner or at all; the risks that our acquisitions and investments, including the acquisition of Alimera, could disrupt our business and harm our financial position and operating results; delays in production, increased costs and potential loss of revenues if we need to change suppliers due to the limited number of suppliers for our raw materials, active pharmaceutical ingredients, excipients and other materials; our reliance on single source third-party contract manufacturing supply for certain of our key products, including Cortrophin Gel, and post-consummation of the acquisition of Alimera, for Alimera’s products; delays or failure in obtaining and maintaining approvals by the FDA of the products we sell; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration, and other regulatory agencies, including among other things, drug recalls, regulatory approvals, facility inspections and potential enforcement actions; our ability to develop, license or acquire, and commercialize new products; the level of competition we face and the legal, regulatory and/or legislative strategies employed by our competitors to prevent or delay competition from generic alternatives to branded products; our ability to protect our intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which we are, or may become, a party; our ability, and that of our suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; our ability to maintain the services of our key executives and other personnel; and general business and economic conditions, such as inflationary pressures, geopolitical conditions including, but not limited to, the conflict between Russia and the Ukraine, the conflict between Israel and Gaza, conflicts related to the attacks on cargo ships in the Red Sea, and the effects and duration of outbreaks of public health emergencies, and other risks and uncertainties that are described in ANI’s Annual Report on Form 10-K, quarterly reports on Form 10-Q, and other periodic reports filed with the Securities and Exchange Commission.

More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (“SEC”), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com 

Source: ANI Pharmaceuticals, Inc.

FAQ

What new product did ANI Pharmaceuticals (ANIP) launch in September 2024?

ANI Pharmaceuticals launched Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution, 6.25 mg/15 mg per 5 mL, in September 2024.

How many new products has ANI Pharmaceuticals (ANIP) launched in 2024?

ANI Pharmaceuticals has launched 14 new products in 2024, including the recent Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution.

What is the market size for Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution in the U.S.?

According to July 2024 IQVIA data, the U.S. annual sales for Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution total approximately $42.6 million.

How does the launch of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution impact ANI Pharmaceuticals' (ANIP) business?

The launch contributes to strong growth in ANI Pharmaceuticals' Generics business and is strategically timed before the cough and cold season, potentially boosting sales and market share.