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Cell Therapeutics Management Discusses Q2 2012 Results - Earnings Call Transcript

For the quarter ended June 30, the total operating expenses were $49.4 million compared to $16.9 million for the same period in 2011. The increase is predominantly due to acquired in-process R&D expense of $29.1 million related to the acquisition of pacritinib from S*Bio, in addition to some expenses related to prelaunch activities for Pixuvri.

As announced in June, we focused our research -- resources on the commercial launch of Pixuvri in EU and the advancement of pacritinib to its Phase III trials. We believe pacritinib represents a high-value product opportunity, addressing an unmet medical need in the myelofibrosis market even in the post-ruxolitinib approval here, which is clearly Phase III ready.

We've instituted a number of cost-containing initiatives, with the goal of reducing our average net operating burn from an average of over $6.5 million per month to now an average of approximately $4 million per month for the remainder of the year.

At the end of the quarter, we had approximately $14.8 million in cash prior to the receipt of $14.3 million in net proceeds received from the same institutional investor that purchased $20 million of stock and warrants in May.

So let's talk about Pixuvri. In the first quarter, we worked with PricewaterhouseCoopers EU life science partners on building the work streams a for cost-effective go-to-market strategy and launch plan for Pixuvri. In the second quarter, we began engaging our partners, including Quintiles, who will be our vendor with which we will hire our sales force. We have also in place a third-party logistics provider for product distribution, pharmacovigilance, product call center and other vendors that are required for compliance and effective launch. We are on schedule to launch in Austria and the Nordic countries starting in September, with Germany targeted to launch in November, at which time we are planning to present our value dossiers to the German health agency and begin the process that we expect will lead to the assignment of an innovation score and potential reimbursement note negotiations. Needless to say, our near-term focus is achieving our goal of developing solid reimbursement strategy for the product in the reference countries like Germany and France.

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