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Thursday, November 7, 2013, 5:09 pm

Raptor third-quarter loss widens as R&D flows to lead drug

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    NOVATO — Raptor Pharmaceutical Corp (Nasdaq: RPTP) on Thursday reported its third-quarter net loss expanded by nearly 70 percent, attributed to more development dollars poured into its recently approved lead drug.

    Raptor Pharmaceutical

    Net loss was $17.3 million, or 29 cents per share, for the third quarter, ended Sept. 30, compared with a $10.2 million net loss for the fiscal quarter ended Aug. 31 of last year.

    For the nine months ended in September, Raptor’s net loss more than doubled from a year before, to $57.4 million, or $1.01 per share, from $27.3 million, or 56 cents per share, for the nine-month period ended in August 2012.

    The Novato-based pharmaceutical company attributed the loss to research and development expenses related to its flagship drug Procysbi, which treats the rare kidney disease nephropathic cystinosis, which effects about 2,000 patients worldwide. The company also has several drugs in its pipeline, contributing further to R&D costs.

    Raptor said R&D expenses for the quarter ended Sept. 30, and the fiscal quarter ended Aug. 31, 2012, were $6.8 million and $6.4 million, respectively. Research and development expenses were $21.4 million for the nine months ended Sept. 30, 2013, compared to $16.4 million for the nine-month period ended August 31, 2012.

    “With the first full quarter of Procysbi sales now complete, I am very pleased with the pace of the launch and our team’s performance,” Raptor CEO Christopher Starr, PhD, said in a statement. “We continue to make significant strides in providing access to Procysbi and communicating its benefits to both caregivers and patients, which bodes well for our future success.”

    The increases in the three and nine months ended Sept. 30, over the comparable periods in 2012 were “primarily due to higher external costs for clinical studies, lab services, and higher staffing expenses, offset by a write-off of an IP license in the prior year,” according to Raptor.

    Likewise, selling and administrative expenses increased to $8.3 million for the quarter ended September from $5.8 million for the fiscal quarter ended August, 2012. Those same expenses were $25.6 million for the nine months ended in September, compared to $12.4 million for the same period in 2012.

    The increase is the result of ramping up sales and marketing costs for the U.S. launch of Procysbi, along staffing expenses, and non-cash stock options, according to Raptor.

     The drug Procysbiis was approved U.S. Food and Drug Administration in June for the management of nephropathic cystinosis in adults and children 6 years and older. The product is also approved by the European Commission for marketing in the European Union.

    Raptor is also currently in phase 2 trials with Procysbi for the treatment of Huntington’s disease, which is expected to be completed in the first quarter of 2014.

    Net product sales for the third quarter were $6.6 million.

    Raptor also said it is increasing guidance for 2013 to at least 160 patients on therapy by the end of the year, and approximately $15 million in net product sales for the year.

    “Beyond cystinosis, our phase 2/3 trial in Huntington’s disease is progressing well and we expect to have top-line data in the first quarter of 2014, followed up by full enrollment of our pediatric non-alcoholic fatty liver disease trial,” Mr. Starr said.

    Raptor had $88.3 million in cash and equivalents at the end of the third quarter, according to Raptor. The company was started in 2005 by former employees of San Rafael-based BioMarin Pharmaceutical.

    Shares of Raptor reached $13.47 each at the end of trading Thursday, up 11 cents a share from Wednesday.

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