Peregrine Pharmaceuticals, Inc. F4Q10 (Qtr End 04/30/10) Earnings Call Transcript

Peregrine Pharmaceuticals, Inc. F4Q10 (Qtr End 04/30/10) Earnings Call Transcript
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Peregrine Pharmaceuticals, Inc. (PPHM)

F4Q10 (Qtr End 04/30/10) Earnings Call

June 14, 2010 4:30 pm ET


Amy Figueroa – IR, BioCom Partners

Steven King – President and CEO

Rob Garnick – Head of Regulatory Affairs

Joe Shan – VP, Clinical & Regulatory Affairs

Chris Eso – VP, Business Operations

Paul Lytle – CFO


Joe Pantginis – Roth Capital Partners

George Zavoico – MLV

Roger Adams [ph]

Ian Somaiya – Piper Jaffray



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Good day everyone, and welcome to the Peregrine Pharmaceuticals fourth quarter and fiscal year 2010 financial results conference call. (Operator instructions) I would now like to turn the conference over to Ms. Amy Figueroa. Please go ahead.

Amy Figueroa

Thanks, Paula.

Good afternoon and thank you for joining us on today's call to discuss our financial results for the fourth quarter and fiscal year ended April 30, 2010 and review our clinical development program. Participating on today’s call are Steven King, President and Chief Executive Officer; Paul Lytle, Chief Financial Officer; Joe Shan, Vice President, Clinical and Regulatory Affairs; Rob Garnick, Head of Regulatory Affairs; and Chris Eso, Vice President of Business Operations.

Before we begin, we would like to advise that this conference call includes forward-looking statements. These forward-looking statements reflect our current views about future events and financial performance that are identified by use of terms and phrases such as believes, expects, plans, anticipates, on target and similar expressions identifying forward-looking statements. These factors 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 the year ended April 30, 2010 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'd now like to turn the call over to our CEO, Steven King. Steven.




Thank you, Amy. I would like to start by thanking our investors and analysts for joining us for our earnings call this afternoon. Before we get started, I wanted to share how frustrated we all are with the current stock price performance, which is not, and I repeat not been attributed to negative events, the company, our cash position and erosion of our fundamentals, or the potential of our technology.

To the contrary, we have had significant positive news, our cash on hand has been increasing, our revenues have been solid and the clinical data and growing body of validating research around our PS Technology has never been more encouraging. All of these positive events and

momentum moving forward make the company’s current stock price and valuation even more frustrating. Our clinical and operational results have never been as solid, and the outlook for the future has never been as promising as it is today. And we will continue to reach out to the institutional investment community in an effort to have this potential reflected in our stock price.

This past quarter was one of the most important quarters in the history of the company, as we achieved several critical milestones that really set the stage for advancing our clinical programs. Building on consistent and positive data seen in multiple and solid tumor indications, we have recently initiated two new randomized non-small cell lung cancer Phase IIb clinical trials. Establishing two potential regulatory paths to our product approval for bavituximab, our first in class PS-targeting monoclonal antibody. These new opportunities build on our third potential regulatory path for approval, which is for our product, Cotara, our novel approach in treating brain cancer.

Later on this conference call, Rob Garnick will review more specifics of our regulatory strategy, which is consistent with the approach he used time and time again successfully during his 24 year career at Genentech. Our data presentation this last quarter were both numerous and robust. We have a total of eight unique data presentations at AACR and at ASCO, which was well received with interest from the scientific, medical and investor communities.

At ASCO, we presented promising data in lung cancer, breast cancer as well as brain cancer, which clearly showed the broad spectrum potential of our novel monoclonal antibodies. A particular highlight was the consistent, positive results in three separate Phase II trials of bavituximab in combination with standard chemotherapy. This data clearly exceeded historical data for these chemotherapies alone in similar patient populations. This compelling data formed the basis for proceeding with our two new randomized Phase IIb clinical trials.

These trials are in refractory, as well as frontline non-small cell lung cancer, and these will be augmented by our ongoing efforts to expand the bavituximab clinical program in accordance with its broad potential in many different solid tumor types. In addition, we are anxious to complete patient enrolment in the important Phase II Cotara brain cancer trial. Looking ahead, we will have multiple opportunities to report clinical data from our ongoing company sponsored trials, as well as from our new investigator sponsored trials program, building towards unblinding top line data from our refractory non-small cell lung cancer trials by the end of 2011.

Joe Shan will provide further context on our clinical data and progress later on the call. Our regulatory and clinical plans could easily exceed our financial resources if they weren’t for the combination of strategic and careful spending and value creation in the form of outside revenues and important cost saving services provided by our wholly owned subsidiary Avid Bioservices. With Avid we are able to manufacture clinical materials for our own company sponsored trials, as well as our IST program at a much lower cost than purchasing from third-party manufacturers, literally resulting in millions of dollars of cash burn savings.

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