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BioMimetic Therapeutics, Inc. (BMTI)

Q1 2010 Earnings Call Transcript

May 10, 2010 4:30 pm ET

Executives

Kearstin Patterson – Director, Corporate Communications

Sam Lynch – President and CEO

Larry Bullock – CFO

Steve Hirsch – COO and EVP, Orthopedics

Analysts

Michael Matson – Wells Fargo Securities

Imron Zafar – Deutsche Bank

Bill Plovanic – Canaccord

Erica Layon – Nobel Financial

Presentation

Operator

Good afternoon. My name is Suzet and I will be your conference operator today. At this time, I would like to welcome everyone to the quarter one 2010 BioMimetic Therapeutics earnings conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks there will be a question-and-answer session. (Operator Instructions)

Thank you. Ms. Patterson, you may begin your conference.

Kearstin Patterson

Thanks, Suzet. Before we begin, I would like to remind you that any statements made during this call can be considered forward-looking statements within 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 can cause actual results to differ materially from those indicated in the forward-looking statements. BioMimetic 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 preclinical and clinical development activity, regulatory oversight and other risks detailed in the company's filings with the Securities & Exchange Commission. Except adds 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 afternoon everyone and welcome to BioMimetic Therapeutics 2010 first quarter earnings conference call. I have with me on the call today Larry Bullock, CFO and Steve Hirsch, our COO and EVP of Orthopedics.

The first part of the call will address our product development programs and corporate activities which will then be followed up with Larry reviewing our financial results for the first quarter ending March 31, 2010. We'll also be happy to answer any questions that you may have during the Q&A portion at the end of the call.

Let me first start by expressing our appreciation to all of you who have reached out to us during the recent severe flooding that took place here in Nashville and to express your concern and your support for us. Happy to say that for the most part the BMTI family was very fortunate in getting through this unprecedented flood with only minimal damage to property and luckily BioMimetic itself did not receive any damage whatsoever. In the face of this severe natural disaster, which caused the loss of more than 30 lives in the Nashville and Middle Tennessee area, more than $1.5 billion in damage, we indeed feel very fortunate.

Now let's turn our attention to the matter at hand. First, we would like to discuss with you what we have been doing during this very busy first quarter. I will provide updates on our lead orthopedic product Canada, Augment Bone Graft, which is being developed as a preferred alternative to the use of autograft. Specifically, I’d first like to discuss with you a new analysis we performed for our pivotal clinical trial which compared Augment to autograph for treatment of foot and ankle fusions and of course, I will give you an update on the status of our PMA.

As a reminder, the goal of the clinical pivotal study was to establish non-inferiority of Augment Bone Graft to autograph that currently recognized bone standard in bone grafting for the treatment of foot and ankle fusions. In doing so, we would establish Augment as an extremely attractive alternative to autograph because its use would spare the patient the pain and potential morbidity affiliated with harvesting of the autograph from another location in the patient's body.

As you know, we released top line data from our North American pivotal trial in October of 2009 and we supplemented that data by providing information on additional secondary clinical end points from the trial along with functional and safety outcomes at our Analyst and Investor Meeting in March.

After reviewing these additional end points, we released in March, we believe that the overall data package for Augment has been strengthened as a result and further supports study hypothesis of non-inferiority. For a combined total of 18 primary and secondary study end points covering radiographic, clinical, functional and quality of life outcomes, 15 of these met statistical significance for non-inferiority which we believe provides a very strong body of evidence that the two treatments are indeed equivalent.

Despite this evidence, however, there remain some questions surrounding the patients who were excluded from the mITT type of analysis due to specific and pre-specified exclusion criteria. And we were still getting asked about whether or not the inclusion of those patients would change the primary end point results.

We have previously stated that we would perform an analysis of these additional patients if and when the FDA requested us to do so, but following this submission of the third and final PMA clinical module which incorporates all the clinical data to the agency, we undertook this post-hoc analysis in an attempt to determine the impact of including those patients that were excluded due to significant protocol violations back into the primary study population.

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