The investigation by the U.S. Health & Human Services Dept. involves Abiomed’s "reimbursement of expenses and remuneration to healthcare providers during the period of July 2012 – December 2012," Abiomed said in its release of its fiscal 4th-quarter and full-year results.
Abiomed said it received a subpoena April 25 from the Boston office of the HHS’s inspector genera as part of a civil investigation. Abiomed said it intends to fully comply with the request.
The Danvers, Mass.-based medical device company reported payments in Massachusetts of $5,465 in 2012, to a pair of registered nurses for "compensation for bona fide services" and "[continuing medical education], third-party conferences, or meetings," according to a Bay State database of medical device and pharmaceutical industry payments to healthcare providers.
Abiomed reported lower profits for its fiscal 4th quarter, compared with the same period last year, despite 15.7% sales growth. Profits were $3.6 million, or 9¢ per share, on sales of $50.5 million for the 3 months ended March 31, representing a bottom-line slide of 3.2%. Full-year profits were off 51.0% at $7.4 million, or 19¢ per share, on sales of $183.3 million, for sales growth of 16.3%. Abiomed said costs & expenses were $46.8 million during the 4th quarter, up 18.2%, and up 23.8% to $175.3 million for the full fiscal year.
"Abiomed delivered another strong quarter, driven by record patient utilization and 200% growth in Impella CP patients," chairman, president & CEO Michael Minogue said in prepared remarks. "For the full fiscal year, Abiomed had solid Impella growth of 19% with overall revenue of $183.6M, and set new records for patients supported and quantity of clinical publications. On the regulatory side, we completed our Impella 2.5 PMA submission and our Impella RP FDA trial."
ABMD shares were down 5.7% to $22.33 apiece as of about 10:40 a.m. today.
Fiscal 2015 sales are forecast at $205 million to $212 million, the company said, with operating margins of 5%-7%. Income from operations was $8.4 million during fiscal 2014, or 4.6% of revenue. Fourth-quarter operations income was $3.7 million, or 7.3% of revenue.
Abiomed also said it’s filed the final module for the pre-market approval application the FDA is requiring for its flagship Impella 2.5 heart pump, containing "clinical data from 215 publications, references 1,638 Impella 2.5 patients, including three FDA studies: Protect I, Protect II, and Recover I, as well as 791 new high-risk Impella patients from the U.S. Impella registry."