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| An illustration of the Impella 2.5 pump in the heart--Screenshot courtesy of Abiomed |
Heart support tech company Abiomed ($ABMD) beat analyst earnings and revenue estimates as well as raised its fiscal 2016 guidance on its latest earnings call. All of this is ahead of incorporating additional U.S. sales for its Impella 2.5, which was approved for a broader indication by FDA on March 23.
The approval enabled an expansion to use during elective and urgent high-risk percutaneous coronary intervention (PCI) procedures. The device had already been cleared in 2008 for a narrower indication, partial circulatory support for up to 6 hours. Now, the company expects to submit PMA supplements for Impella CP and Impella 5.0, which also have 510(k) clearance.
Abiomed raised its fiscal year 2016 guidance to $285 million to $295 million from a prior range of $260 million to $270 million. Its fiscal 2015 just ended on March 31.
In addition to the PCI indication, which the company expects includes more than 50,000 U.S. patients, the guidance boost was also based on the continued launch of Impella CP.
"Our guidance includes approximately $4 million to $6 million of revenue from the launch of Impella CP, as we plan to continue to govern the pace of the launch, maintain rigor in training and focus on optimal patient outcomes as the best route to becoming standard of care," said Abiomed chairman, President and CEO Michael Minogue on the earnings call.
"In addition, we have not yet incorporated Impella revenue from Japan and will provide updates later in the year, as we get closer to approval. Consistent with historical patterns, we expect to see higher revenue levels in the second half of the year than in the first half," he added.
Abiomed had $63.4 million in global Impella revenue last quarter, a 38% gain over the $46.1 million total during the same quarter a year prior. Full-year revenues were $212.7 million, up 27% from $167 million for fiscal 2014.
Last quarter, 27 hospitals made their initial purchases of Impella, bringing the total customer base to 958 sites. For Impella CP, the latest product, 57 hospitals were first-time buyers last quarter, bringing that U.S. total to 640.
Abiomed was up 13% in early trading on its May 5 earnings news, giving it a market cap of almost $3 billion.
- here is the earnings release