CTIC

CTI BioPharma Corp. (CTIC)

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Cell Therapeutics (CTIC)

Q4 2012 Earnings Call

February 28, 2013 4:30 pm ET

Executives

Monique M. Greer - Senior Vice President of Corporate Communications and Investor Relations

James A. Bianco - Principal Founder, Chief Executive Officer, President and Executive Director

Steven E. Benner - Chief Medical Officer and Executive Vice President

Matthew J. Plunkett - Executive Vice President of Corporate Development

Analysts

Robert Cummins Hazlett - Roth Capital Partners, LLC, Research Division

Reni J. Benjamin - Burrill & Company, Research Division

Presentation

Operator

Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the Cell Therapeutics Fourth Quarter Full Year 2012 Financial Results Conference Call. [Operator Instructions] This conference is being recorded today, February 28, 2013.

I would now like to turn the conference over to our host, Monique Greer, Senior Vice President of Corporate Communications and Investor Relations for Cell Therapeutics. Please go ahead.

Monique M. Greer

Thanks, Liz. Good afternoon, everyone, and thank you for joining us today for our fourth quarter and full year 2012 results conference call. Following formal remarks by management, the conference call will be open for questions. With me today are Jim Bianco, President and Chief Executive Officer; and Steve Benner, Chief Medical Officer. Matt Plunkett, Executive Vice President of Corporate Development; and Lou Bianco, Executive Vice President of Finance will be available during our question-and-answer period.

A press release was issued after market closed today, a copy of which can be found on the Homepage and in the Investor section of our website at celltherapeutics.com. I also want to point out that going forward, we plan on reporting our quarterly results after market close versus our prior practice of reporting premarket.

The agenda for the call is as follows: Jim will begin with a brief overview of the fourth quarter and full year, particularly regarding the launch and commercialization of Pixuvri in the European Union, Steve will follow with an update on our development pipeline, and then Jim will close and open the call for questions.

Before we begin, please note that during the course of the call, we will be making forward-looking statements based on current expectations. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. Additional information concerning these risks and uncertainties is continued in the Risk Factor section of our 2012 Annual Report on Form 10-K for the year ended December 31, 2012, which will be on file this afternoon and in the company's other periodic reports and filings with the Securities and Exchange Commission.

I will now turn the call over to Jim. Jim?

James A. Bianco

Thanks, Monique. Good afternoon, everyone. I'd like to start out by highlighting how 2012 was a successful year for the company in many ways. The approval of our lead product, Pixuvri, by the European Commission as the first therapy for treatment of patients with multiply relapsed or refractory aggressive B-cell NHL was a transformative event for CTI, representing our third drug approval in the company's history and our second European approval. This event marked our reemergence as a commercial hematology-oncology company. And more importantly, for patients with aggressive B-cell NHL, Pixuvri provides hope and offers new treatment standards.

In May 2012, we expanded our late stage pipeline of product candidates, the acquisition of pacritinib, an oral, once-daily JAK2/FLT3 inhibitor that's demonstrated a meaningfully clinically benefit and good tolerability in myelofibrosis patients in our Phase II clinical studies. Importantly, without treatment emergent myelosuppression, seen with other agents in this class, Steve will discuss this exciting program later on in the call.

So before providing an update on the Pixuvri commercial activities, let me highlight our financial results. For the year ended December 31, 2012, CTI reported a net loss of $115.3 million or $1.98 per share, including the $29.1 million for the acquired in-process research and development expense related to the acquisition of pacritinib from S*Bio. That's compared to a net loss of $121.1 million or $3.53 per share for the same period in 2011. Net loss for the fourth quarter ended December 31, 2012, decreased by 10% to $18.9 million or $0.20 per share compared to a net loss of $20.9 million or $0.47 per share for the same period in 2011, taking into consideration one-time settlement income that we received in 2011.

Total net operating expenses for the year were $101.5 million, again, which also includes the $29.1 million related to the pacritinib acquisition.

Regarding expense guidance for 2013, net loss from operations is expected to be approximately $60 million to $65 million, excluding any noncash stock-based compensation expense. The projected 2013 net loss from operations is expected to be comparable to 2012 and primarily relates to expected changes in a positive net product contribution from Pixuvri commercial operations as we intend to operate the commercial business with a net positive P&L; management of our SG&A expenses, including management of sales and marketing expenses to drive Pixuvri sales, as well as medical affairs expenses in the support of educational programs for the hemo community in the EU; and lastly, R&D expenses, including the management of cost for ongoing and planned clinical trials involving pacritinib, the post-approval study of Pixuvri, which is pursuant to the post-marketing commitment that we have with the European Medicines Agency.

Turning to our balance sheet, we ended 2012 with cash and cash equivalents of $50.4 million and no debt, and approximately 109.8 million common shares outstanding.

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