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Abiomed, Inc. (ABMD)
515i Reclassification Panel
December 12, 2012 1:00 pm ET
Mike Minogue – Chairman, President & Chief Executive Officer
Bob Bowen – Vice President & Chief Financial Officer
Susie Lisa – Senior Director of Investor Relations and Corporate Development
Raj Denhoy – Jefferies & Company
Greg Simpson – Wunderlich Securities
Dan Garofalo – Piper Jaffray
Mike Rich – Raymond James
Steve Beuchaw – Morgan Stanley
Matt – Credit Suisse
Bruce Nudell – Credit Suisse
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Thanks very much, and thanks to everyone for joining us for the Abiomed 515i Reclassification Process Post-Panel Conference Call. I’m Susie Lisa and I’m joined today by Mike Minogue, our Chairman, President and CEO, as well as by Bob Bowen, CFO of Abiomed.
Before we begin I need to mention that statements made during this conference call concerning our expectations for the 515i process and regulatory approvals for our Impella products, our future business and operating results, our existing or new products, our progress toward commercial growth, future opportunities, expected regulatory approvals and similar matters are all forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties.
Information contained in these forward-looking statements is inherently uncertain and actual performance or results may differ materially due to many important factors. Our actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors including uncertainties associated with the 515i process and regulatory changes including the contents of any final rules adopted by the FDA, development and testing, and related regulatory approvals; the results of any clinical trials, competition, technological change, government regulation, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in our filings with the Securities and Exchange Commission including the most recently filed Annual Report on Form 10(k) and Quarterly Report on Form 10(q).
You should not place undue reliance on any forward-looking statements which speak only as of the date of this conference call. Abiomed undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that may occur after the date of this conference call or to reflect the occurrence of unanticipated events.
Now, on to the call. Our format is simple. Mike will start with some overview commentary and takeaways from the FDA 515i Reclassification Panel meeting held on December 6, 2012, in which the FDA panel recommended Class III status for temporary ventricular support devices in the non-roller type cardiopulmonary bypass blood pump category. After Mike’s opening remarks we will then take your questions.
Two things of note before I turn it over to Mike. One is that we encourage you to consult Abiomed’s [ATA] filing dated as of December 7, 2012, which contains three items: first, our press release from December 6, post the panel; secondly, Abiomed’s presentation to the FDA 515i Panel “Classification Determination for Non-Roller Type CPB Pumps” dated December 6, 2012; and thirdly, the Impella clinical literature summary given to the FDA 515i Panel.
The second thing to note is that as per our December 5, 2012, press release, this conference call is being held to discuss 515i Reclassification Panel and further details. Therefore, our discussion is limited to that topic and as per usual we will not be making any comments about the current quarter. With that I’d like to turn it over to Mike.
Thanks, Susie. Hello everyone. As you know, last week the FDA 515i Program Panel deliberated about the classification for all current and future devices in a non-roller type cardiopulmonary bypass blood pump category and recommended the devices in the temporary ventricular support category which [includes that] Impella should be confirmed as a Class III device.
This recommendation will likely be outlined in a proposed order by the Agency in the near future and require more feedback during an open comment period. Following a review of the comments the Agency will issue a final order to implement the final classification. However, it appears likely that all devices in the temporary ventricular support category will require a premarket approval or PMA in the future. As per the 515 reclassification process, and confirmed by the FDA Panel, products will remain on the market with current indications while manufacturers submit and move through the PMA application process.
I’d like to use the call to clear up any confusion from the Panel’s discussion as well. Specific to our clearance, the FDA 510(k) clearance letter and summary from June 2008, which is available online, states that “Abiomed provided a detailed analysis based on clinical data from a combination of 109 outside of the US and 20 US patients to address patient safety.” The Panel also discussed guidelines. To note, the current ACC, AHA and SCAI Guidelines do not include a review of PROTECT II nor the US Impella registry nor the SHOCK II intra-aortic balloon pump study which were all published after the update in November, 2011.
Abiomed believes these data may alter the guidelines upon inclusion. We believe the FDA received the following feedback on Impella from the 515 panel members: the device should remain available during the 515 process due to an existing clinical need; confirmation at further clinical studies, Impella may provide hemodynamic benefit; and finally, that these are difficult patient populations to study and randomize based on protocol and ethical considerations.