Shares of Montreal biopharmaceutical company Theratechnologies fell 15% on Wednesday after announcing a risk of a temporary interruption in the supply of its injectable drug tesamorelin (Egrifta).
Management said it was issuing the warning because of the “voluntary” and “unexpected” shutdown of its contract manufacturer’s facilities following an inspection by the U.S. Food and Drug Administration (FDA), and because of the delay in U.S. health authorities’ review of the product’s resumption of distribution.
Theratechnologies management emphasizes that the observations made by the American equivalent of Health Canada are not related to the Egrifta manufacturing process, but rather to the manufacturing environment of the plant.
Theratechnologies management maintains that the manufacturer’s activities at its plant should resume by mid-October.
Egrifta is a medicine that helps reduce excess abdominal fat in adults infected with the human immunodeficiency virus (HIV) who have lipodystrophy. This condition affects the redistribution of fat that includes the accumulation and loss of fat in certain areas of the human body and the consequences are considered serious.
“We are working closely with our manufacturer and other stakeholders and will continue to work with the FDA to resume manufacturing of Egrifta,” said Theratechnologies CEO Paul Lévesque in a press release.
Theratechnologies intends to implement measures to “carefully” manage Egrifta inventory to meet patient demand through early January and estimates that these measures will result in a revenue shortfall of approximately US$1.6 million related to Egrifta for fiscal year 2024.
More details are expected next month when Theratechnologies publishes its June, July and August financial performance.
Theratechnologies shares ended Wednesday’s session down 15% at $1.61 on the Toronto Stock Exchange. The current stock price gives the Montreal company a value of approximately $75 million.