Cardiology player Abiomed hogged the headlines today with its stellar fiscal 2015 Q3 financials and the announcement of FDA approval of its Impella RP for patients with right ventricular failure.
On the back of strong demand for its Impella line of catheter-based heart pumps, Abiomed reported quarterly profits of $12.7 million on revenue of $62 million, up 34% year-over-year. The company added 21 hospitals to its installed customer base in the quarter, bringing the total to 931 facilities.
The shares rocketed from $38 to $53 following the Tuesday announcement just after market close. They have since fallen slightly, but are still up 30% on the strong earnings report. Abiomed also raised its guidance for fiscal year 2015 revenue guidance to about $225 million from around $210 million. It projected sales of $260-$270 million in FY 2016.
And the company concurrently announced that it received a Humanitarian Device Exemption for devices that target rare conditions from the FDA for its Impella RP for the subset of patients who develop problems with the right side of their heart following a heart attack or heart procedure. It is delivered via catheter through a small hole in the leg.
Currently, the device's market size in the U.S. is about 4,000 patients, but the company plans additional trials to expand the indication and aims to achieve sales of $100 million in the U.S., The Boston Globe reports. It has a list price of $20,000 to $25,000, similar to Abiomed's devices for the left side of the heart.
Equity analysts at Leerink write in an analyst note that "U.S. Impella growth was driven by significantly higher utilization vs. new center adds (additions)." Currently the devices have a 510(k) approval for low to moderate risk devices. Leerink expects PMA approval of Impella in early 2016 to give the company the freedom "to more aggressively and actively market Impella 2.5 using the already large and still growing supportive body of clinical evidence which includes several cost-effectiveness studies--something from which the company was restricted under 510(k) approval to simply marketing as a tool for improving hemodynamics."
Leerink says that the Impella 2.5 and Impella CP treated around 20,000 patients in FY 2014, and said the newly approved Impella RP could treat more than 8,000 patients in the future.