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BioMimetic Therapeutics (BMTI)

Q3 2012 Earnings Call

November 05, 2012 4:30 pm ET

Executives

Kearstin Patterson - Director of Corporate Communications

Samuel E. Lynch - Founder, Chief Executive Officer, President and Director

Lawrence E. Bullock - Chief Financial Officer, Principal Accounting Officer and Corporate Secretary

Analysts

Tao Levy - Loewen Ondaatje McCutcheon Limited

Mark Landy - Summer Street Research Partners

Kevin Kotler - Broadfin Capital, LLC

Presentation

Operator

Good afternoon. My name is Therese, and I will be your conference operator today. At this time, I would like to welcome everyone to the Q3 2012 BioMimetic Therapeutics Earnings Conference Call. [Operator Instructions] Thank you. I would now turn the call over to Kearstin Patterson, Senior Director of Corporate Communications.

Kearstin Patterson

Thanks, Therese. Before we begin, I would like to remind you that statements made during this call about our prospects and plans are considered forward-looking statements. Such statements include those regarding our expectations regarding the timing and substance of our amendment to the Augment PMA and the FDA response, along with statements concerning plans of future clinical trials, anticipated regulatory actions, product development plans, business development initiative and potential protection provided by new patents.

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 and improving preclinical and clinical development activities, regulatory oversights and other risks detailed under the heading Risk Factors on our Form 10-K filed with the Securities and Exchange Commission.

Except as required by law, BioMimetic undertakes no responsibility for updating the forward-looking statements made during this call. Please note that a press release was issued prior to this call. Additionally, 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. Samuel Lynch, President and CEO of BioMimetic Therapeutics.

Samuel E. Lynch

Thank you, Kearstin. Good afternoon, everyone, and welcome to BioMimetic's 2012 Third Quarter Conference Call. Larry Bullock, our CFO, is joining me on the call today, as usual. During the first part of the call, I will update you on our product development programs and our business activities, then Larry will review our financial results for the third quarter ended September 30, 2012. We'll also be happy to answer any questions that you may have during the Q&A at the end of the call.

Our main business objectives, of course, consists of our efforts to pursue regulatory approvals and commercialization in the United States and in several markets located outside the U.S. and the continued development of our sports medicine product candidates, the introduction of Augmatrix to complement our existing Orthobiologics portfolio of product candidates, and of course, carefully managing our assets.

With that, let's discuss our third quarter 2012 activities and financials. As you know, the main priority requiring management's attention over this quarter and for, frankly, the last 1.5 years is the FDA approval of Augment for its use as an alternative to autograft in hindfoot and ankle fusion procedures.

And as we announced this summer, we've completed and filed an amendment to the Augment PMA, which provided a substantial amount of supplemental information that was requested by the FDA in its post-panel response letter.

Based on the results of these additional analyses across a full range of clinical and safety measures, it is our view, and continues to be our view, that the updated data provides sound scientific evidence and, in many cases, even stronger evidence than that previously available, demonstrating a reasonable assurance of Augment's safety and effectiveness.

To further strengthen the benefit risk profile of Augment, in September, we also submitted an additional amendment to our Augment PMA application that included the result of a study conducted on becaplermin or Regranex to evaluate cancer mortality. Regranex contains the same synthetic protein that is found in Augment, but is topically administered on to open skin sores daily for weeks to months compared to the onetime implantation of Augment during foot and ankle fusion surgery. The results of the study indicated no difference in either cancer incidence or cancer mortality between patients who received Regranex and those who did not. The retrospective follow-up analyses were conducted using patient records of 6,429 Regranex patients, compared to a match group of patients -- of patient records, of 6,429 similar patients that were treated without the use of Regranex. In other words, the study, an analyzed data, from over 12,858 total patients.

Patients with foot ulcers and no prior cancer incidence were selected from Veterans Affairs and Medicare patient records and were followed for up to 11 years, from 1998 through 2009, to identify new malignancies and any cancer-related death. These results are from a new study, which is not associated with any study or extension study that had been reported previously prior to September. Additionally, this study evaluates a completely different set of patient records, again, than any previously commissioned study, and involve, of course, a much larger patient population, followed for a much longer period of time.

Given this, we believe this study exonerates PDGF from being associated with any risk of cancer mortality in diabetic foot ulcer patients using Regranex, which in turn, certainly should further alleviate any residual FDA concern regarding Augment.

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