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BioMimetic Therapeutics, Inc. (BMTI)

Q3 2008 Earnings Call Transcript

November 10, 2008, 4:30 pm ET


Kearstin Patterson – Director, Corporate Communications

Samuel Lynch – Chairman, President and CEO

Larry Bullock – CFO


Imron Zafar – Deutsche Bank

Michael Matson – Wachovia Capital Markets

Bill Plovanic – Canaccord Adams

Debjit Chattopadhyay – Boenning & Scattergood

Erica Selin – Stanford Group



Good day, ladies and gentlemen, and welcome to the third quarter 2008 BioMimetic Therapeutics earnings conference call. My name is Eric and I will be your audio coordinator for today. At this time, all participants are in listen-only mode. We will facilitate the question-and-answer session at the end of the presentation. (Operator instructions)

I would now like to turn your presentation over to your host, Ms. Kearstin Patterson, Director of Corporate Communications. Please proceed.

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 statements. 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’s products, unproven pre-clinical and clinical development activities, 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 web cast 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. Samuel Lynch, President and CEO of BioMimetic Therapeutics.

Samuel Lynch

Thank you, Kearstin, and good afternoon everyone, and welcome to BioMimetic Therapeutics 2008 third quarter earnings conference call. I have with me on the call today Larry Bullock, our CFO, and Steven Hirsch, our COO and Executive Vice President of Orthopedics.

The first part of the call will address our product development programs and business activities, which will then be followed up with Larry reviewing our financial results for the third quarter of the year ending September 30, 2008, which were released this afternoon. We will also be happy to answer any questions that you may have during the Q&A portion of the call at the end of your conclusion of our opening remarks.

Let us begin with our lead orthopedic product candidate, Augment Bone Graft, which we formerly called GEM OS1. We will update you on our activities related to this product candidate including the progress towards completion of our ongoing pivotal studies in North America and the EU as well as our application for product licensing in Canada.

Let me first of about one of the important issues for the company which is the progress of our ongoing pivotal trial. In our earnings press release issued this afternoon, we announced that as of November 7, 330 patients have been enrolled in our North American pivotal in Augment Bone Graft which we are developing as a replacement for autograft for the treatment of foot and ankle fusions. There are currently 34 sites actively enrolling patients in the United States and Canada and we have made excellent progress since our second quarter earnings conference call on August 8th, during which we had reported 220 patients had been enrolled at that time.

The actions that we began several months ago that were targeted at improving performance and study enrollment has indeed proven very successful and we have driven a strong upward enrollment trend. We have been especially pleased with the positive reception that our new clinical specialists and monitors have received from the study sites. The specialists have indeed become parts of the teams of our sites resulting in greater visibility of our study and ultimately more patients enrolled.

Our challenge grants offered to the Outreach and Educational Foundation of the American Orthopedic Foot and Ankle Society and to the Canadian Orthopedic Foot and Ankle Society have also helped to create positive awareness among our investigators. The addition of several high volume sites has already delivered results for us and we have recently added two more new sites which brings again the total of 34 sites actively enrolling patients in this study.

None of these efforts though would have been successful without the commitment and the enthusiasm of our clinical investigators and we want to thank them all for their continuing efforts on our study. We do note that as we approach two significant holiday periods between now and year end that we would anticipate a slight decrease in enrollment rates due to the reduction of scheduled surgeries during these time frames. We do not in any way anticipate any changes in our trends for any other reasons. That being said we believe that we will remain well on track to complete enrollment around the end of this year or early in 2009.

Also in this quarter, we announce the results from the independent data monitoring committee that is overseeing our ongoing North American pivotal study. Based on the DMC’s review of all available safety data from the first 254 patients at the futility analysis on data from the first 79 patients to have completed their six month follow up visit, the independent data monitoring committee has recommended that the pivotal trial should proceed unchanged.

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