MDXG - MiMedx Group Inc - Business Update Call Transcript

    Company Name:MiMedx Group Inc
    Event Title:Business Update Call Transcript
    Event Date:05-Sep-2013
    Event Time:11:00 AM ET



    Good day ladies and gentlemen. Welcome to the MiMedx Conference Call. My name is Clinton, I'll be your operator for today.

    At this time all participants are in listen-only mode. We will conduct the question-and-answer session towards the end of this conference. [Operator Instructions].

    I'd now turn the call to Pete Petit. Please go ahead.

    Parker H. "Pete" Petit

    Chairman and Chief Executive Officer
    Thank you, Clinton. I have with me Bill Taylor, our President and Chief Operating Officer . We are going to let Mike start the call. Mike?

    Michael J. Senken

    Chief Financial Officer
    Thanks Steve this presentation contains forward-looking statements within the meaning of Section 27-A of the Securities Act of 1933 and Section 21-E of the Securities Exchange Act of 1934. These statements are based upon the current beliefs and expectations of our management and are subject to risks and uncertainties. Actual results may differ materially from those set forth within, contemplated by or underlying the forward-looking statements based on factors described in this conference call, and in our reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2012 and our most recent 10-Q.

    We do not undertake to update or revise any forward-looking statements except as may be required by the company's disclosure obligations and filings it makes with the Securities and Exchange Commission under federal securities laws.

    With that I would like to turn the call back over to our Chairman and CEO, Pete Petit.

    Parker H. "Pete" Petit

    Chairman and Chief Executive Officer
    Thank you Mike. First let me attempt to put this issue related to our CFO's letter from FDA and prospective. Our press release was very specific about the type of letter we received and the conversation we've had with the FDA staff in that conversation I made it clear that MiMedx has many of the concerns about the development of the Amniotic Membrane Allograft products as does the FDA.

    We have seen some rather -- violations of the 361 regulations and my years in healthcare might be clear to me that those type of continued violations will and should cause the FDA to react to individual cases and if concerns were significant enough to take broader steps to ensure that their regulations have been followed. Since MiMedx is the largest and clear leader in this area, it is in our interest to be certain that this tissue is appropriately regulated.

    We do not wait to see the very bright future this unique tissue that has been created by mother nature become tarnished by improper uses claims and other mis-management. Therefore we are in total agreement with the FDA play some additional scrutiny on these products. Relative to the way that MiMedx conducts the sales related to regulatory managed I would characterize us as conservative both William Taylor's and my decade of experience help us clearly understand the long-term benefits of strictly adhering to the FDA guidelines and regulations. We take no actions without critical evaluations with requirements in productive area with our FDA Council who incidentally was the former FDA staff attorney.

    We also have an FDA consultant, he was an executive in the agency for decades. Now relative to current situation. As you know, yesterday the FDA posted on its website 'untitled letter' question at company's micronized injectible product's from marketing solely under Section 361 of the Public Health Services Act. FDA issued that letter on August 28, 2013.

    As explained on the FDA websites and 'untitled letter' is an initial regulated industry that sites violations that do not meet the threshold of regulatory significance for a warning letter.

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