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F2Q13 Earnings Call
November 1, 2012 8:00 a.m. ET
Susan Lisa - IR
Mike Minogue - Chairman, President, and CEO
Bob Bowen - VP and CFO
Brooks West - Piper Jaffray
Greg Simpson - Wunderlich Securities
Charles [Crawson] - Sidoti & Company
Anthony Petrone - Jefferies
Steve Beuchaw - Morgan Stanley
Previous Statements by ABMD
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Thank you. This is Susie Lisa. I’m the senior director for investor relations and corporate development at Abiomed, and I have with me here this morning Mike Minogue, our chairman, CEO and president, and Bob Bowen, our CFO.
I hope everyone made it safely through the storm, and appreciate your flexibility with our rescheduled date here this morning. The format for today's call will be as follows. First, Mike will discuss strategic highlights for the quarter and then turn to our key operational and strategic objectives for the year, with particular emphasis upon our clinical and regulatory processes and progress. Bob will then review the financial results for the quarter and provide an update on our corporate goal of operational excellence. We will then open the call to your questions.
Before turning the call over to Mike, I want to remind you that during the course of today's conference call and the question-and-answer session that follows, we may make projections or other forward looking statements that are subject to the Safe Harbor provisions of the securities laws regarding future events or the financial performance of the company.
We caution you that these statements are only predictions and that actual results may differ materially. We also alert you to the risks contained in the documents we filed with the Securities and Exchange Commission, such as our annual and quarterly reports on Form 10-K and 10-Q. We do not undertake any obligation to update or correct any forward looking statements.
And now I’ll turn the call over to Mike.
Good morning everyone. We’re pleased to report the most profitable quarter in company history, with 27% growth in total revenue at $37.4 million. We believe our sustained year over year Impella growth curve of greater than 30% for more than three years indicates Impella is emerging as a critical device for patients requiring percutaneous circulatory support.
In addition, we continued to execute our plan and achieve significant milestones this quarter, with our Impella CP 510(k) clearance, publication of PROTECT II in circulation, announcement of new Impella CPT codes, and progress on our Symphony technology.
We are positioned for another record year, and maintain our place as one of the fastest-growing, profitable medical device companies. Congratulations to the entire team for your results and efforts.
On another note, as noted in the press release, Abiomed recently received a HIPAA administrative subpoena from the U.S. Attorney’s office. The subpoena seeks documents related to the Impella 2.5.
We understand the investigation to be focused on marketing and labeling. Abiomed is in the process of responding to the subpoena, and intends to cooperate fully. The request for information does not prohibit our ability to support our customers and help them achieve the best possible outcomes for their patients. As is standard legal practice, it is not appropriate for us to comment further on this matter at this time.
So today I will focus on our third corporate goal for fiscal ’13, executing on our clinical and regulatory processes, and Bob will cover the rest. So, for the clinical and regulatory processes, first I will explain our strategic plan for FDA regulatory approvals on Impella. Second, I will discuss the 515 program initiative, and last highlight our existing recent Symphony progress.
For some regulatory history, Abiomed received the Impella 2.5 510(k) clearance in June 2008, and the submission included data on 129 patients. The existing Impella 2.5 510(k) clearance is for “partial circulatory support, using an extracorporeal bypass control unit for periods of up to six hours. It is also intended to be used to provide partial circulatory support for periods of up to six hours, during procedures not requiring cardiopulmonary bypass. The Impella RECOVER 2.5 percutaneous cardiac support system also provides pressure measurements which are useful in determining intravascular pressure.”
The Impella CP was 510(k) cleared this September with the same indications as the Impella 2.5, and represents greater than 30% higher flow with the same access site for percutaneous support. This is what many physicians have been waiting for, and the customer demand is evident, which was confirmed at TCT.
While not always mentioned, the new Impella AIC console, with autoflow features, is also impacting the ease of use and learning curve for the technologists. Abiomed is committed to supporting clinical studies and research that may help future regulatory approvals for expanded uses for the Impella line of products. Abiomed has conducted and published three FDA studies, PROTECT I, RECOVER I, and PROTECT II, and created an ongoing IRB approved Impella registry on real-world clinical usage, published under Europella and USpella in 2010 and 2011 respectively.
As of this quarter, over 150 peer-reviewed papers have been published on Impella. In the recent months, Abiomed, in coordination with the FDA, has taken extensive actions to correct our noted compliance issues identified in our annual report. Abiomed has conducted an internal compliance audit of marketing materials and recertified the field team and management on our Impella labels.