ANI Pharmaceuticals offers US$560M for Swedish rare disease drugmaker Egetis Therapeutics

USA—ANI Pharmaceuticals has offered US$560 million to acquire Swedish biotechnology company Egetis Therapeutics, expanding its rare disease portfolio and gaining access to Emcitate, the first approved treatment for MCT8 deficiency.

The New Jersey-based pharmaceutical company announced the proposed acquisition on Thursday alongside its third-quarter earnings.

If completed, the transaction will add Emcitate to ANI’s portfolio, strengthening its position in the rare disease market.

Emcitate targets an underserved patient population

Emcitate received European regulatory approval last winter and U.S. approval on September 28, becoming the first treatment approved for MCT8 deficiency.

The rare genetic disorder, also known as Allan-Herndon-Dudley syndrome (AHDS), is estimated to affect one in 70,000 males worldwide and more than 1,000 people in the United States.

The condition disrupts the transport of thyroid hormones into brain cells, affecting neurological development, cognition, mobility and overall health.

Thyroid hormones are essential for normal brain development during pregnancy and early childhood.

“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 during the company’s third-quarter earnings call.

Emcitate carries orphan drug designation in both the United States and European Union, with patent protection extending to 2045.

ANI estimates that the medicine could generate peak annual sales of US$300 million.

The drug launched in the United States on October 27.

ANI reported that more than 100 patients had received genetic confirmation of MCT8 deficiency, while 60 were already accessing Emcitate through an expanded access programme.

Market access and development opportunities

ANI plans to use its commercial infrastructure and rare disease capabilities to expand access to the treatment.

Securing reimbursement from insurers and government-funded healthcare programmes will be a priority.

Before the proposed acquisition, Egetis had engaged the three largest pharmacy benefit managers and more than one-third of state Medicaid programmes.

ANI’s head of rare diseases, Chris Mutz, expects the absence of alternative approved treatments to support reimbursement negotiations with commercial insurers and Medicaid.

The acquisition will also expand ANI’s research pipeline.

Egetis’ development programme includes preclinical studies investigating Emcitate’s potential in resistance to thyroid hormone beta (RTH-beta), another rare thyroid-related disorder.

ANI’s existing rare disease portfolio includes autoimmune treatment Cortrophin and ophthalmic medicines Iluvien and Yutiq, acquired through its 2024 purchase of Alimera Sciences.

Acquisition terms and financial performance

ANI has offered SEK 11.25 per Egetis share (US$1.15), representing a 27% premium over the Swedish company’s average share price during the preceding 60 trading days.

Egetis’ board unanimously recommended that shareholders accept the offer.

Shareholders representing 42% of the company’s shares have indicated acceptance, although ANI requires approval from holders of at least 90% for the transaction to proceed.

The acceptance period is expected to begin later in November and continue through December.

The final transaction value will reflect Egetis’ planned sale of a rare paediatric disease priority review voucher (PRV) awarded following Emcitate’s FDA approval.

The voucher is expected to generate US$190 million in proceeds, reducing the adjusted enterprise value of the acquisition to approximately US$434 million.

The proposed deal follows ANI’s acquisition of Alimera Sciences for more than US$380 million in 2024 and its US$163 million purchase of Novitium in 2021.

The company has also expanded through acquisitions of generic and branded medicines from several pharmaceutical manufacturers.

ANI reported third-quarter revenue of US$290.8 million, up 27.6% year over year and above Wall Street estimates. It expects full-year revenue of about US$1.1 billion.

Meanwhile, Egetis reported third-quarter revenue of US$2.2 million and a net loss of US$14.3 million. The company ended the quarter with US$26.7 million in cash.

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