Global Net Product Sales for PROCYSBI® of $69.5 Million for 2014
2015 PROCYSBI Revenue Guidance of $80-$90 Million
Company to Host Conference Call and Webcast Today at 4:30 p.m. ET/1:30 p.m. PT
NOVATO, Calif., Feb. 26, 2015 (GLOBE NEWSWIRE) -- Raptor Pharmaceutical Corp. (Nasdaq:RPTP) reported financial results for the fourth quarter and year ended December 31, 2014 and provided an update on recent corporate developments.
Summary
Global net product sales for PROCYSBI® (cysteamine bitartrate) delayed-release capsules were $17.3 million for the fourth quarter ended December 31, 2014 compared to $10.2 million for the same period in 2013. Global net product sales for PROCYSBI for the full year 2014 were $69.5 million compared to $16.9 million for the same period in 2013. Global net product sales in 2014 came in at the top end of the company’s guidance range of $65 to $70 million.
Raptor reported a net loss on a GAAP basis of $18.9 million for the fourth quarter, or $0.29 per share, and a net loss of $52.5 million, or $0.83 per share, for the full year.
The company made several key hires in the fourth quarter of 2014 and in January 2015 to build the executive management team and appointed two new members to the Board of Directors in January 2015.
The Centre Hospitalier Universitaire or CHU, of d’Angers, France presented 18-month data from Phase 2/3 (Cyst-HD) study of RP103 in Huntington’s disease at the Huntington’s Study Group meeting in November 2014. Data demonstrated that RP103 improved Total Motor Score, or TMS, by 2.2 points in the modified intent-to-treat (mITT) population.
Raptor is establishing 2015 financial guidance with global net product sales for PROCYSBI between $80 and $90 million and non-GAAP operating expense, excluding non-cash stock-based compensation expense, between $115 and $125 million.
“2014 was a very productive year for Raptor. I am pleased with the strong commercial performance for PROCYSBI, which reflects Raptor’s ability to maximize access for cystinosis patients in existing regions and expand into new markets,” said Julie Anne Smith, President and CEO of Raptor Pharmaceuticals. “We expect additional gains in 2015 with a focus on continued value creation as we grow PROCYSBI’s footprint, advance our pipeline, including our Phase 2b pediatric NASH, Phase 2/3 Huntington’s and Phase 2 mitochondrial diseases programs, and strategically pursue the most attractive business opportunities.”
Fourth Quarter and Full Year 2014 Financial Highlights
Raptor provides non-GAAP financial measures, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the section of this press release below entitled “Non-GAAP Financial Information and Other Disclosures” for a full discussion on this subject.
Net Product Sales
PROCYSBI global net product sales for the fourth quarter of 2014 were $17.3 million versus $10.2 million for the fourth quarter of 2013. Net product sales for the full year 2014 totaled $69.5 million versus $16.9 million of sales for 2013. Growth was driven by continued market penetration in the U.S. and the launch in Germany. PROCYSBI became commercially available in the U.S. in June 2013 and in Europe in April 2014.
Cost of Sales
Cost of sales were $3.3 million for the fourth quarter of 2014, compared to $0.8 million for the fourth quarter of 2013. Cost of sales for the year 2014 totaled $9.4 million versus $1.7 million for the year 2013.
Research & Development (R&D)
R&D expenses for the fourth quarter of 2014 were $13.9 million compared to $7.8 million for the fourth quarter of 2013. R&D expenses for the year 2014 totaled $43.5 million versus $29.2 million for the year 2013. The increase was primarily due to increases in staffing, preclinical studies, clinical trials and non-commercial drug manufacturing expenses.
Selling, General and Administrative (SG&A)
SG&A expenses were $16.1 million for the fourth quarter of 2014 compared to $12.4 million for the fourth quarter of 2013. SG&A expenses for the year 2014 totaled $56.7 million versus $37.9 million for the year 2013. The increase was primarily due to additional sales and marketing costs associated with the commercialization of PROCYSBI in the U.S. and in Europe.
Interest Expense
Interest expense for the fourth quarter of 2014 was $3.1 million compared to $2.7 million for the fourth quarter of 2013. Interest expense for the year 2014 totaled $14.0 million versus $6.8 million for the year 2013. The increase was due mainly to the higher royalty interest on increased sales in the fourth quarter and the full year of 2014 as well as the $70.0 million of increased principal of the two debt agreements with HealthCare Royalty Partners effective July 1, 2014.
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