ANI Pharmaceuticals is forking over more than half a billion dollars to broaden its rare disease business.
Alongside it’s Q3 earnings Thursday, the New Jersey-based pharma announced a $560 million offer for Swedish rare disease drugmaker Egetis Therapeutics. Should the deal go through, Egetis would bring its recently approved medicine Emcitate into the ANI fold.
Emcitate, which passed muster with the European regulators last winter and in the U.S. on Sept. 28, represents the first treatment approved to treat MCT8 deficiency, a rare genetic condition that is estimated to affect one in 70,000 males worldwide and more than 1,000 in the U.S.
“This is a devastating condition; children are born with it. Families provide around the clock care, and until recently there was no approved treatment,” ANI chief executive Nikhil Lalwani said on the company's third-quarter earnings call Thursday.
Also known as Allan-Herndon-Dudley syndrome (AHDS), MCT8 deficiency can affect a child's cognition, mobility and overall health. In children with the condition, the thyroid hormone can't enter cells in the brain due to a defect in the hormone transporter MCT8. Thyroid hormones play a key role in proper brain development both during pregnancy and in early childhood.
With orphan drug designation in both the EU and the U.S., Emcitate has patent protection through 2045 and could reach $300 million in peak sales, per ANI's reckoning.
The drug launched in the U.S. last week on Oct. 27. On Thursday, ANI said more than 100 U.S. patients have been genetically confirmed for treatment and 60 are already receiving Emcitate through an expanded access program.
“We believe we can leverage our resources and capabilities to maximize the reach and impact of Emcitate in one of the most underserved patient communities,” Lalwani said.
ANI’s head of rare diseases, Chris Mutz, said securing payer coverage will be a priority for Emcitate’s U.S. launch. Prior to the deal, Egetis engaged the three largest pharmacy benefit managers and more than a third of state Medicaid plans. Given that there is no other approved treatment option for MCT8 deficiency, “we expect there to be a path to access and reimbursement for both commercial and Medicaid payers,” Mutz said on the earnings call.
The deal will expand ANI’s growing rare disease business, which currently includes autoimmune treatment Cortrophin, as well as Iluvien and Yutiq—both ophthalmic drugs that ANI acquired through its Alimera Sciences buyout in 2024. The Egetis deal will also bring the broader Emcitate R&D program to ANI, which includes preclinical studies assessing the drug to treat a separate rare condition known as resistance to thyroid hormone beta (RTH-beta).
ANI’s offer comprises an 11.25 Swedish kroner ($1.15) per-share purchase price for Egetis, reflecting a 27% premium on the company's 60-day average trading price.
Egetis’ board of directors has unanimously recommended that Egetis shareholders accept the offer. So far, owners of 42% of the company’s shares have done so, but ANI said owners of 90% of the shares must accept for the offer to go through. An acceptance period is slated to kick off later this month and run through December.
The value of the deal will also be impacted by Egetis' recent decision to sell a rare pediatric disease priority review voucher (PRV) that it won from the FDA with its approval, ANI caveated in its announcement. With proceeds slated to come in at $190 million for the PRV, ANI clarified that the enterprise value of its deal for Egetis works out to roughly $434 million after adjusting for that sale.
ANI’s history suggests it’s never been shy about dealmaking.
The pharma shelled out more than $380 million for its 2024 deal with Alimera. And in 2021, it bought out Novitium for $163 million upfront. Beyond full-on company acquisitions, ANI has also scooped up multiple generics from drugmakers like Oakrum and Teva, as well as branded products from AstraZeneca and Merck, which originally developed its lead product Cortrophin.
On top of the buyout, ANI posted a strong quarter, beating Wall Streat estimates with $290.8 million in revenue, up 27.6% year over year. The company expects full-year revenue to hit $1.1 billion, which is in line with consensus estimates.
Also on Thursday morning, Egetis reported $2.2 million in third quarter revenue, while reporting a $14.3 million loss. The biopharma ended the quarter with $26.7 million in cash.