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BioMimetic Therapeutics Inc. (BMTI)

Q1 2008 Earnings Call

May 9, 2008 8:30 am ET


Kearstin Patterson - Associate Director of Corporate Communications

Sam Lynch - President, CEO

Larry Bullock - CFO

Steven Hirsch - COO


Tao Levy - Deutsche Bank

Brian Wong - Next Generation Equity

Michael Matson - Wachovia Securities

Caroline Corner - Pacific Growth Equities

Bill Plovanic - Canaccord Adams



Good day, ladies and gentlemen, and welcome to the first quarter 2008 BioMimetic Therapeutics Earnings Call. My name is Eric. I'll be your coordinator for today. And, at this time, all participants are in a listen-only mode. We'll facilitate the question-and-answer session towards the end of the conference. (Operator Instructions)

I would now like to turn your presentation over to Miss Kearstin Patterson, Associate Director of Corporate Communications for BioMimetic Therapeutics, Inc. Please proceed, ma'am.

Kearstin Patterson

Thanks, Eric. Before we begin, I would like to remind you that any statements made during this call can be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

These forward-looking statements are based on the current intent and expectations of the management of BioMimetic Therapeutics. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. There are many important factors that could cause actual results to differ materially from those indicated in the forward-looking statement.

BioMimetic's actual results and the timing and outcome of events may differ materially from those expressed in, or implied by, the forward-looking statements because of risks associated with the marketing of BioMimetic products and proven pre-clinical and clinical development activity, regulatory oversight, and other risks detailed in the company's filings with the Securities and Exchange Commission. Except as required by law, BioMimetic undertakes no responsibility for updating the statements made during this call.

Please note that, for your convenience, this conference call webcast will be archived on the Investor Information section of our website for at least 30 days.

Now, I would like to hand the call over to Dr. Sam Lynch, President and CEO of BioMimetic Therapeutics.

Sam Lynch

Thank you, Kearstin, and good morning, everyone. Welcome to BioMimetic Therapeutics 2008 first quarter earnings conference call. I have with me on the call today Larry Bullock, our CFO, and Steven Hirsch, our COO.

During the call today, I will discuss our product development programs and business activities for the first part of 2008 and then Larry will review our financial results for the first quarter ended March 31, '08, which were released yesterday afternoon. I know we just spoke a few weeks ago so we'll keep today's update relatively brief but we'll certainly be happy to answer any questions that you may have during the Q&A portion of the call.

As you know, we had a very memorable first quarter 2008, with something some things I certainly would love to repeat, such as generating over $33 million in cash from the sale of the remainder of General Therapeutics business and other things that I wouldn't care to repeat anytime too soon, such as the posting by the FDA of the early communication related to Regranex, a J&J product. Overall, though, I believe that the outcomes of both of these events have made BioMimetic a stronger organization and have demonstrated the capabilities of the management team here to successfully work through issues that would have tested any organization.

Receiving an affirmative letter, such as we did two or three weeks from the FDA in the midst of an ongoing pivotal clinical trial, was an unusual and very positive step by the agency and would not have happened had our team not been able to quickly engage in open and productive discussions with the agency to clarify the issues involved. I remain very proud of the execution of our management team during the course of those events.

This past Monday, we announced that enrollment in our U.S. pivotal trial with GEM OS1, which we are developing as a replacement for autograft for the treatment of foot and ankle fusions, has reached 170 patients.

As we have previously indicated, enrollment in this trial did slow somewhat at the end of March and into early April, following the release of the early communication by the FDA. However, it appears to now have fully recovered to pre-early communication levels and we expect enrollment to continue increasing over the coming months. As you all know, and I'm sure you've done the calculations for yourselves. We enrolled approximately 45 patients over the past two months, which included the slow period following the early communication.

To further facilitate enrollment, we are expanding the number of sites to 32 from 28, 28 of those within the U.S., plus the additional four sites in Canada. This process should be complete within the next few weeks. We are also replacing four study sites that were low enrollers from the original group of investigators.

Secondly, we are also initiating a physician-to-physician referral program, which will channel potential trial patients from general and family practitioners directly to the foot and ankle specialists who are participating in our study. We are in the process of rolling out this program and should begin to see its impact within the next six to eight weeks.

And third, we are hiring several clinical specialists who will be dedicated to facilitating the enrollment efforts at our clinical study sites as opposed to our CRAs or clinical research associates, whose primary job is to ensure the high quality and completeness of the clinical trial data. These clinical specialists will be working with the site staff to keep them focused on our study and to ensure that we capture all eligible study participants.

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