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ANI Pharmaceuticals to purchase Alimera Sciences

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ANI Pharmaceuticals, Inc. and Alimera Sciences, Inc. announced the companies have agreed to a definitive agreement for ANI to acquire Alimera.

Alrighty, let’s start with these companies.

First up: ANI Pharmaceuticals.

Founded in 1996 and headquartered in Baudette, Minnesota, the integrated biopharmaceutical company develops, manufactures, and markets branded and generic prescription-based pharmaceutical products for diseases with high unmet needs (particularly rare diseases).

Now Alimera.

Founded in 2003, the Alpharetta, Georgia-based global biopharmaceutical company specializes in the commercialization and sale of prescription ophthalmic pharmaceuticals.

  • Its primary focus: retinal disease

Of interest: The company’s FDA-approved ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated for the treatment of diabetic macular edema (DME).

  • It’s also marketed with an indication to treat noninfectious posterior uveitis (NIU) in 17 European countries (but not currently in the U.S.)

Doesn’t the company have another NIU therapy?

Indeed it does! Back in May 2023, Alimera acquired the commercial rights to EyePoint Pharmaceuticals’ YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg.

  • The details: This FDA-approved therapeutic is indicated for treating chronic non-infectious uveitis (NIU) impacting the posterior segment of the eye.

The similarities between ILUVIEN and YUTIQ: Both implants release fluocinolone acetonide for up to 36 months.

  • Clinical update: YUTIQ is currently undergoing a phase 4 Synchronicity study, slated to conclude in November 2025.

How about some details on the purchase?

Per ANI, the company is acquiring Alimera for “$5.50 per share in cash at closing,” as well as a single non-tradable contingent value right (CVR) that gives ANI the right to receive “up to $0.50 per share” pending the company’s achievement of certain net revenue targets in 2026 and 2027.

  • The total transaction value: an estimated $381 million

Important to note: Both companies’ Board of Directors have approved the deal.

I’ve got to ask: Why purchase Alimera?

With the company’s two ophthalmic-based commercial products already available in the United States, this acquisition aligns with ANI’s new focus on ophthalmology as a key strategic therapeutic area, according to ANI President and CEO Nikhil Lalwani.

Plus: ANI recently expanded its rare disease team earlier this year by promoting Purified Cortrophin Gel (Cortrophin Gel) among ophthalmologists.

  • Note: This FDA-approved prescription-based medication is indicated to treat severe acute and chronic allergic and inflammatory ocular conditions such as:
    • Allergic conjunctivitis
    • Keratitis
    • Iritis and iridocyclitis
    • Optic neuritis
    • Chorioretinitis

And from a revenue standpoint?

With the addition of ILUVIEN and YUTIQ, ANI expects to add an estimated $150 million (45%) in pro forma 2024 revenues to the company, Lalwani noted.

As a bonus: This accretive acquisition (in other words: a transaction that increases ANI’s earnings per share [EPS]) is also expected to substantially increase the company’s shareholder values in adjusted non-Generally Accepted Accounting Principles (GAAP) EPS in 2025 and thereafter.

  • Specifically: An additional estimated $35 to $38 million in 2025 adjusted non-GAAP
    • Click here for an explanation of non-GAAP earnings

Let’s talk ophthalmic significance.

Needless to say (though we will anyway), this deal expands ANI’s overall presence within the ophthalmic space thanks to the now-three FDA-approved ocular therapeutics.

Even further: “The company estimates that there is over 50% overlap between high potential prescribers of Cortrophin Gel and ILUVIEN / YUTIQ,” according to ANI.

Lastly…  when is the deal effective?

The companies plan to complete the acquisition by late Q3 2024, so stay tuned!

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