Peregrine Pharmaceuticals (PPHM)
F2Q 2013 Earnings Call
December 10, 2012 4:30 pm ET
Steven W. King - Chief Executive Officer, President, Director, Chief Executive Officer of Avid Bioservices Inc and President of Avid Bioservices Inc
Robert Garnick - Head of Regulatory Affairs
Joseph S. Shan - Vice President of Clinical & Regulatory Affairs
Previous Statements by PPHM
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Joseph Pantginis - Roth Capital Partners, LLC, Research Division
George B. Zavoico - McNicoll, Lewis & Vlak LLC, Research Division
Good day, ladies and gentlemen, and welcome to the Peregrine Pharmaceuticals Incorporated Second Quarter Fiscal Year 2013 Financial Results Conference Call. [Operator Instructions] Today's conference is being recorded.
I would now like to turn the call over to Jay Carlson of the Investor Relations department. Please go ahead, sir.
Thanks, Jamie. Good afternoon, and thank you for joining us. On today's call, we have Steve King, President and Chief Executive Officer; Paul Lytle, Chief Financial Officer; Joe Shan, Vice President of Clinical and Regulatory Affairs; and Rob Garnick, Head of Regulatory Affairs.
Steve will begin by providing a company update on how this event sets the stage for the numerous near-term clinical data milestones. Rob will then discuss our clinical and regulatory plans as we advance our Cotara program. Joe will provide an update as to our recent clinical activities, and Paul will then finish with a summary of our financial results for the second quarter fiscal year 2013 ended October 31, 2012. After our prepared remarks, we welcome your questions.
Before we begin, we would like to remind you that during this call, we will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ. These forward-looking statements reflect our current views about future events and financial performance and are identified by the use of terms and phrases such as believe, expect, plan, anticipate, on target and similar expressions identifying forward-looking statements. These risks include, but are not limited to, the risk factors detailed from time to time in our filings with the Securities and Exchange Commission, including but not limited to: The annual report on Form 10-K for our fiscal year 2012 ended April 30, 2012, and quarterly report on Form 10-Q for the second quarter ended October 31, 2012, which was filed today.
Investors should not rely on forward-looking statements because they are subject to a variety of risks, uncertainties and other factors that could cause actual results to differ materially from our expectations. And we expressly do not undertake any duty to update forward-looking statements, whether as a result of new information, future events or otherwise.
I'll now turn the call over to Steve.
Steven W. King
Thanks, Jay. During the quarter, we continued to make progress in all areas of our business with the regulatory developments for Cotara, continued growth of the Avid manufacturing business and continuing clinical development and approaching milestones for the bavituximab program. I will briefly discuss each of these areas before turning the call over to the rest of the management team for a more in-depth discussion.
The recent agreement with the FDA on the pivotal trial design for Cotara was an important development for the program and for the company. In the end, we believe we have achieved our goal going into the end of Phase II discussions. Namely, a trial that is appropriately sized for the patient population and a trial we can execute in a reasonable time frame. With this agreement in hand, we can now escalate partnering discussions while we engage worldwide regulatory agencies and continue making preparations for the study. Partnering is a key priority for this program, and we remain very active on that front. Rob will talk a little more on this regulatory development shortly.
This is another solid quarter for Avid, with strong revenues and a continuing solid backlog of future work. Avid has become a self-sustaining business with significant growth -- future growth opportunities. Paul will talk in more detail about the revenues and future projections for Avid a little later in the call.
On the ongoing clinical front, we remain enthusiastic about our bavituximab oncology clinical program with important clinical milestones on the horizon, including overall survival data from randomized pancreatic and front-line non-small cell lung cancer trials; possible data from 5 ongoing ISTs; as well as resolution of final results from our ongoing internal review of discrepancies we've discovered in our second-line non-small cell lung cancer study. We recognize that many parties, including investors, potential partners and even ourselves, are anxious to learn the final results from this review.
Completing a review is a high priority throughout the company, and we are trying to complete this work as soon as possible. We are conducting a thorough review of this trial, including over 15 vendors and 40-plus clinical sites at which patients were treated, and the testing of thousand of samples. The execution of this high-priority plan has required a great deal of forethought, cooperation from our vendors and internal expertise and resources.
The goal of this review is to be able to generate a final data set that we believe could be used in discussions with the FDA to support advancing the program into a pivotal trial. Our partnering phase for bavituximab has not changed. The partnering discussions are still ongoing, with potential partners remaining engaged, and like all of us, awaiting the outcome from this review of the second-line non-small cell lung cancer study.