ANI inks $163.5M deal to acquire Novitium Pharma

ANI is growing its capabilities and pipeline with an acquisition. The company has signed a definitive agreement to acquire Novitium Pharma for $163.5 million, including $89.5 million in cash and $74 million in equity plus two potential future cash earn-outs of up to $46.5 million.

The acquisition adds to ANI the privately held, New Jersey-based pharmaceutical company's development, manufacturing, and commercialization capabilities. ANI's board has approved the transaction and it is expected to close in the second half of 2021.

“Strengthening our well-established generics business with enhanced development capabilities and increased focus on niche opportunities is a key pillar of ANI’s growth strategy," said Nikhil Lalwani, ANI president and CEO. "The acquisition of Novitium aligns with this strategy, adding a best-in-class R&D engine that delivers sustainable growth through new product launches and offering upside through niche 505(b)(2) opportunities. The addition of a U.S. based, state-of-the-art manufacturing facility and enhanced scale to our CDMO business are other attractive advantages of this acquisition. We also look forward to welcoming Samy, Chad, Vijay and the entire Novitium team to ANI,” said Nikhil Lalwani, ANI president and CEO.

Samy Shanmugam, co-founder and president, and Chad Gassert, co-founder and CEO of Novitium, said, “We are delighted to join ANI as we enter this next phase of exciting growth at Novitium Pharma. We look forward to supporting ANI to execute on their strategy of growing their business, expanding and diversifying their product portfolio, and creating long-term value for their investors.”

Novitium anticipates launching more than 25 additional products in 2021 and 2022, including products with the Food and Drug Administration competitive generic therapy designation. The company currently has 21 abbreviated new drug applications filed with the FDA and more than 30 additional products under development.

Novitium is currently advancing three 505(b)(2) candidates in Oncology and Hypertension. These 505(b)(2) products will build on ANI’s increasing focus on niche opportunities, including its first Paragraph IV filing in 2020 and the filing of injectables ANDAs in 2021.

Novitium adds nine new customers to ANI’s growing CDMO business. Additionally, Novitium brings with it a 50,000-sq.-ft. East Windsor, N.J. facility, which includes 27 manufacturing suites and eight clinical suites supporting R&D, commercial manufacturing and packaging.

An ongoing 20,000-sq.-ft. building expansion will add 18 new manufacturing suites. Novitium’s annual production capacity is approximately 2 billion units in aggregate across tablets, capsules, liquid suspensions and solutions, powders and powder for oral suspension, controlled release and potent compounds.

The combination is expected to be accretive to ANI’s adjusted non-GAAP EPS in the first 12 months after closing. The transaction is expected to add approximately $15 million to adjusted EBITDA in the second half of 2021, assuming a mid-year 2021 close.