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ANI Pharmaceuticals seeing growth with rare disease drug sales

Its emerging rare disease unit is driving sales growth for ANI Pharmaceuticals Inc. Looking ahead the company wants to build and expand rare disease drug sales.

“The first imperative is scaling up our rare disease business,” said Nikhil Lalwani, chief executive of ANI, in a morning earnings conference call with analysts. “We are actively exploring assets to acquire or partner on.”

In January 2022, ANI started selling purified Cortrophin gel which treats inflammation and stress associated with 23 autoimmune diseases. Nine of those conditions are considered rare. A rare disease is defined as one affecting fewer than 200,000 people in the U.S.

Baudette-based ANI reported a fourth quarter net loss of $4.7 million and adjusted earnings-per-share of 76 cents. That topped consensus expectations by nine cents per share.

The company’s stock was flat for the day, closing up 0.1%.

The company did not have any rare disease-related sales in the fourth quarter of 2021. For the fourth quarter of 2022, rare disease accounted for 18.7% of its fourth quarter sales of $94.2 million. Cortrophin is currently the only product in the rare disease division.

Overall fourth quarter sales were up 54.7%.

The company is providing full year guidance for 2023 revenue in the range of $360 million to $385 million, which would reflect growth of 14% to 22%.

ANI is forecasting that cortrophin itself will see sales of $80 million to $90 million this year. Those numbers would represent growth of 92% to 116% for that drug alone.

ANI has now wrapped up the consolidation of its manufacturing operations by completing the shutdown of its facility in Oakville, Ontario.