The Justice Department has opened a criminal investigation into the company's baby formula plant, but Abbott sees signs of improvement in the year ahead.

By Burl Gilyard

January 25, 2023 at 5:09PM

(Associated Press/The Minnesota Star Tribune)

Baby formula issues and a decline in COVID-19 test sales continue to hamper Abbott Laboratories as the company now faces a U.S. Justice Department investigation.

The department recently opened a criminal investigation into Abbott's manufacturing facility in Sturgis, Mich., which was closed for several months in 2022 over potential contaminant concerns, resulting in a national shortage of the vital infant nutrition.

Chicago-based Abbott said Wednesday that sales in its U.S. pediatric nutrition unit were down more than 20% in the fourth quarter, ending Dec. 31.

After a Wall Street Journal report Friday about the federal investigation, Abbott said the Justice Department "has informed us of its investigation, and we're cooperating fully."

The Sturgis facility is fully operational, said Abbott CEO Robert Ford, who told analysts Wednesday that the company projects the business will rebound. "I expect our overall nutrition business to be growing at that pre-pandemic level, 4% to 6%," he said.

Federal inspectors last year found bacteria and some unsanitary conditions at the facility, but the U.S. Food and Drug Administration could not establish a connection between bacteria at the plant and children with reported illnesses.

Another of Abbott's business units — diagnostics — is also in transition as the COVID-19 outbreak settles into a new endemic state. Sales of its popular test kit plunged compared with a year ago, with U.S. diagnostic sales down 29% in the quarter.

If excluding COVID-19 test sales, the company's U.S. diagnostic sales grew 16.8%.

Abbott's fourth-quarter sales of $10.1 billion were down 12% from a year ago largely because of lower demand for its COVID-19 tests. Its fourth-quarter profit fell 48.1% to $1 billion.

Despite bumpy results, Abbott topped analysts' expectations, delivering $1.03 earnings per share for the quarter. The company's stock closed down 1.4% Wednesday.

While diagnostics and pediatric nutrition sales fell, Abbott's largest unit is medical devices, which accounts for 70% of the company's overall sales. It will likely benefit from a post-pandemic demand bump as patients elect to undergo procedures.

U.S. sales of Abbott's FreeStyle Libre glucose monitoring devices grew 42% to $1.1 billion during the quarter. The Libre devices alone accounted for 11% of the company's fourth-quarter sales, while the entire nutrition division was about 18%.

Ford projects Libre, which is housed within its diabetes division, will earn $10 billion annually by 2028. U.S. medical device sales rose 12.2% for the quarter.

Abbott has about 5,000 employees in Minnesota.

In its previous earnings call in October, Ford said the company was drawing up plans for a new $500 million infant-formula plant. In December, Abbott said it will be built in Bowling Green, Ohio.