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BioMimetic Therapeutics, Inc. (BMTI)

Q4 2008 Earnings Call Transcript

March 13, 2009 8:30 am ET

Executives

Kearstin Patterson – Director, Corporate Communications

Sam Lynch – CEO & President

Larry Bullock – CFO

Steve Hirsch – EVP & COO

Analysts

Imran Zafar – Deutsche Bank

Michael Matson – Wachovia Capital Markets

Debjit Chattopadhyay – Boenning

Anup – Canaccord Adams

Franz Tudor [ph] – Incremental Capital [ph]

Presentation

Operator

Good day, ladies and gentlemen, and welcome to the Fourth Quarter 2008 BioMimetic Therapeutics Earnings Conference Call. My name is Erica and I will be your coordinator for today. At this time, all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of this conference. (Operator instructions).

I would now like to turn the presentation over to your host for today's call, Ms. Kearstin Patterson, Director of Corporate Communications for BioMimetic. Please proceed.

Kearstin Patterson

Thanks, Erica. 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 intents 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 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 Web site for at least 30 days.

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

Sam Lynch

Great. Thank you, Kearstin, and good morning, everyone. And thank you for joining us bright and early on this Friday, the 13th. Welcome to BioMimetic Therapeutics 2008 fourth quarter and year end earnings conference call. I have with me on the call today, Larry Bullock, our CFO and Stephen Hirsch, our COO and EVP for 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 fourth quarter and yearend December 31 '08, which were released yesterday evening. We will also be happy to answer any questions that you may have during the Q&A portion of the call.

We saw many of you at our analyst and investor meeting at the end of February just a few weeks ago and we appreciate your continued support and interest in the BioMimetic story. We hope that that meeting provided you greater insight into our upcoming corporate milestones and allowed you to get a feel for the immediate and longer-term market potential of our product candidates. In case you weren't able to attend that meeting, the webcast is located on our Web site.

The past year was a challenging but very productive one for BMTI. Some of the highlights for 2008 included the completion of enrollment in both our North American and EU pivotal clinical trials for Augment Bone Graft; reporting of encouraging data in our pilot clinical trials for Augment Injectable Bone Graft, our second generation orthobiologics product in our pipeline; the sale of our orofacial therapeutics business; and the issuance of a patent that will provide protection for our Augment product line and certain other PDGF product formulations until at least 2025.

Finally, we were able to achieve liquidity for some of our assets that were tied up in auction rate securities by arranging a $39 million loan secured by those bonds. We are proud of our record of accomplishments during 2008 and the strong reputation that we believe that we are building within the orthopedic community.

Let me take a few minutes to give you some more details on the significant product development milestones that we've accomplished throughout '08.

I will start with our lead orthopedic product candidate, Augment Bone Graft, which is being developed as a preferred alternative to the use of autologous bone graft.

The enrollment in our North American pivotal trial has been one of the Company's most visible milestones, for those of you who have been following BMTI's progress, due largely to a strong acceleration of enrollment in the fourth quarter, we successfully completed enrollment in December. Therefore, we expect to be able to file the clinical data with the FDA in the fourth quarter of this year.

We have previously discussed with you our plan to do a modular filing of our PMA. The first two sections of the PMA, the pre-clinical and the manufacturing and quality sections are on schedule to be filed this spring, very shortly, allowing time for the agency to review these data well in advance of the clinical module.

So, when our clinical data package is sent to the FDA in the fall, we hope that we will have already been able to address all the questions the agency may have on these first two modules. We believe this strategy will allow the most efficient and timely review and ultimate FDA approval. Since we know there will be a good deal of interest in the results of the clinical trial, we will work to determine the most appropriate venue to release the data later this year.

Read the rest of this transcript for free on seekingalpha.com