Raptor Pharmaceutical Corp. (NASDAQ:RPTP) reported financial results for the first quarter ended March 31, 2015 and provided an update on recent corporate developments.
Global net product sales for PROCYSBI® (cysteamine bitartrate) delayed-release capsules were $20.5 million for the first quarter ended March 31, 2015 compared to $12.1 million for the same period in 2014.
Raptor reported a net loss on a GAAP basis of $19.7 million for the first quarter, or $0.28 per share.
Cash and cash equivalents were $134.5 million as of March 31, 2015, which excludes $92.0 million of net proceeds raised in the April 2015 public offering.
In April, Michael DesJardin joined Raptor as Senior Vice President of Technical Operations to lead manufacturing efforts.
All completing patients enrolled in the company’s CyNCh pediatric NASH study finished 12 months of treatment including the biopsies with 86% of randomized subjects completing treatment and end-of-study liver biopsy.
Raptor maintains its 2015 financial guidance of global net product sales for PROCYSBI of between $80 and $90 million with a non-GAAP operating expense, excluding cost of goods and non-cash stock-based compensation expense, of between $115 and $125 million.
“Our core business continued to deliver strong growth and we entered 2015 with significant momentum. I am proud of our global team who are focused and resolved on improving patients’ lives around the world,” said Julie Anne Smith, President and CEO of Raptor Pharmaceutical. “In addition, this year, we are focused on advancing and expanding our portfolio through internal research and development and external business development efforts.”
First Quarter 2015 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 first quarter of 2015 were $20.5 million compared to $12.1 million for the first quarter of 2014. As a reminder, the company now recognizes revenue when PROCYSBI is received by the specialty pharmacy instead of when PROCYSBI shipment receipt is confirmed by the patient. Revenue growth in the first quarter of 2015 was driven by continued market penetration in the U.S. and demand from the launch in Germany and other European territories. The company recorded sales in Germany, Austria, Switzerland, Norway, Denmark and Brazil during the first quarter of 2015.
Cost of Sales
Cost of sales were $3.7 million for the first quarter of 2015, compared to $1.3 million for the first quarter of 2014. Cost of sales were higher in the first quarter of 2015 than the first quarter of 2014 due to an increase in product sales and inventory reserves.
Research & Development (R&D)
R&D expenses were $16.6 million for the first quarter of 2015 compared to $9.5 million for the first quarter of 2014. 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 $14.8 million for the first quarter of 2015 compared to $12.1 million for the first quarter of 2014. 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 was $4.5 million for the first quarter of 2015 compared to $3.0 million for the first quarter of 2014. The increase was due mainly to the higher royalty interest on increased sales in the first quarter of 2015.
GAAP net loss in the first quarter of 2015 was $19.7 million, or $0.28 per share, compared to a net loss of $14.9 million, or $0.24 per share, in the first quarter 2014.
Non-GAAP net loss, which excludes stock-based compensation expense, for the first quarter of 2015 was $16.8 million, or $0.24 per share, compared to a net loss of $12.5 million, or $0.20 per share, in the first quarter of 2014.
Cash and Cash Equivalents
Raptor ended the first quarter 2015 with $134.5 million in cash and cash equivalents, which excludes the $92.0 million in net proceeds received from a follow-on public offering completed on April 8, 2015.
2015 Financial Guidance
- Raptor’s 2015 global net product sales guidance for PROCYSBI of $80 to $90 million remains unchanged.
- The company reiterates full-year non-GAAP operating expense guidance, excluding cost of goods and non-cash stock-based compensation expense, of between $115 and $125 million.
Product and Pipeline Updates
PROCYSBI for Nephropathic Cystinosis
- Currently, PROCYSBI is commercially available to patients in the U.S., where it is the market leader in nephropathic cystinosis, as well as Germany, Austria, Switzerland, Norway and Denmark. In addition, during the first quarter of 2015, Raptor delivered its first reimbursed patient order of PROCYSBI to Brazil on a named patient basis. The company expects to make additional shipments on a named patient basis in new territories during the remainder of 2015.
- In February 2015, Raptor was awarded the New Treatment Award by the Lysosomal Disease Network for PROCYSBI at the WorldSymposium.
RP103 for Huntington’s Disease (HD)
- In the Phase 2/3 Huntington’s disease (CYST-HD) trial, the last patient in the open label phase of the study is expected to complete the 36-month treatment visit this summer. The outcome of the 36-month data analyses will be available in 2H15.
RP103 for Pediatric Non-alcoholic Steatohepatitis (NASH)
- In the Phase 2b pediatric NASH (CyNCh) trial, all enrolled patients have completed the Week 52 visit and received their final biopsies, with 86% of randomized subjects completing 52 weeks of treatment and receiving their end-of-study liver biopsy. The evaluation of all final biopsies by a blinded central reader is under way.
- The company anticipates release of the CyNCh study data by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2H15.
RP103 for Mitochondrial Diseases
- The Phase 2 study for mitochondrial diseases, including Leigh syndrome, remains ongoing. More than 50% of patients have been enrolled in the study.
- The company expects to conduct interim analyses in 2H15 after four patients and 12 patients have completed the study to evaluate for early signs of efficacy of RP103 and to determine final sample size.
Anticipated Upcoming Milestones
- August 14, 2015 – PDUFA date for label expansion for PROCYSBI to include nephropathic cystinosis patients aged 2-6 years
- 2H15 – RP103 Phase 2b CyNCh data in pediatric NASH
- 2H15 – 36-month data from the RP103 Phase 2/3 CYST-HD study in Huntington’s disease
- 2H15 – Interim RP103 Phase 2 data in mitochondrial disorders including Leigh syndrome
- 2015 – Regulatory guidance update regarding clinical development and approval pathway of RP103 in Huntington’s disease (Original Source)
Shares of Raptor Pharmaceutical closed today at $9.71, up $0.01 or 0.1%. RPTP has a 1-year high of $12.20 and a 1-year low of $7.12. The stock’s 50-day moving average is $10.81 and its 200-day moving average is $10.06.
On the ratings front, Raptor has been the subject of a number of recent research reports. In a report issued on February 27, Wedbush analyst David Nierengarten reiterated a Sell rating on RPTP, with a price target of $5, which represents a potential downside of 49.8% from where the stock is currently trading. Separately, on February 24, Oppenheimer’s Christopher Marai reiterated a Hold rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, David Nierengarten and Christopher Marai have a total average return of 45.5% and 25.9% respectively. Nierengarten has a success rate of 60.5% and is ranked #16 out of 3594 analysts, while Marai has a success rate of 67.5% and is ranked #65.
Raptor Pharmaceutical Corp is abiopharmaceuticalcompany. It is engaged indeveloping and commercializing transformative treatments for people affected by rare and debilitating diseases.