ANI Pharmaceuticals Announces Acquisition of Fluconazole Tablets

Rhea-AI Summary

ANI Pharmaceuticals announced the acquisition of Fluconazole Tablets USP from a private company for $3.0 million. The product's current annual U.S. market is valued at approximately $40 million, indicating significant market opportunity. Interim President and CEO Patrick Walsh expressed enthusiasm for integrating this product into ANI's portfolio, which is expected to enhance margins and competitive positioning. Fluconazole Tablets are used primarily for treating vaginal and esophageal candidiasis, among other conditions.

Positive

• Acquisition of Fluconazole Tablets for $3.0 million, entering a $40 million market.
• Expected enhancement of margins and competitive positioning through integration.
• Manufacturing to be done at the Oakville, Canada facility, leveraging existing capabilities.

Negative

• Potential risks related to FDA product approval delays.
• Competition from other manufacturers could affect market share.
• Uncertainties in importing raw materials may pose operational challenges.

BAUDETTE, Minn., July 6, 2020 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the acquisition of Fluconazole Tablets USP, 50mg, 100mg, 150mg, and 200mg from a private company for $3.0 million.  The current annual U.S. market for this product is approximately $40 million, according to IQVIA/IMS Health.

Patrick Walsh, ANI's Interim President and CEO stated, "We are excited to add Fluconazole Tablets, currently manufactured at our site in Oakville, Canada, to our commercial generic portfolio.  With this acquisition we further advance our strategy of expanding the ANI product portfolio via the Oakville plant.  By leveraging our commercial, manufacturing and packaging capabilities we expect to enhance the margin opportunity and competitive position of this product."

About Fluconazole Tablets USP

Fluconazole Tablets USP is indicated for the treatment of vaginal candidiasis (vaginal yeast infections due to Candida) and oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. It is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.

For more information, including the complete list of indications and usages, please see the Full Prescribing Information.

About ANI

ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. The Company's targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products. For more information, please visit our website 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 manufacturing and commercialization of the acquired product and any additional products manufactured at the Oakville, Canada site and 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, the risk that the Company may face with respect to importing raw materials; competition from other products; acquisitions; contract manufacturing arrangements; delays or failure in obtaining product approval from the U.S. Food and Drug Administration; general business and economic conditions; market trends; products development; regulatory and other approvals and marketing.

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.

For more information about ANI, please contact:
Investor Relations
IR@anipharmaceuticalscom

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SOURCE ANI Pharmaceuticals, Inc.

FAQ

What did ANI Pharmaceuticals acquire on July 6, 2020?

ANI Pharmaceuticals acquired Fluconazole Tablets USP from a private company for $3.0 million.

What is the market size for Fluconazole Tablets?

The current annual U.S. market for Fluconazole Tablets is approximately $40 million.

What are the indications for Fluconazole Tablets?

Fluconazole Tablets are indicated for the treatment of vaginal candidiasis and oropharyngeal and esophageal candidiasis.

How will the acquisition impact ANI Pharmaceuticals?

The acquisition is expected to enhance margins and improve competitive positioning in the market.

Where will Fluconazole Tablets be manufactured?

Fluconazole Tablets will be manufactured at ANI's facility in Oakville, Canada.