PROCYSBI® Product Sales Increased 43% Year over Year to $23.3 Million in Second Quarter
Balance Sheet Strengthened with over $220 Million in Cash, Cash Equivalents and Short-Term Investments as of June 30, 2015
Company to Host Conference Call and Webcast Today at 4:30 p.m. ET/1:30 p.m. PT
NOVATO, Calif., Aug. 6, 2015 (GLOBE NEWSWIRE) -- Raptor Pharmaceutical Corp. (NASDAQ:RPTP) today announced financial results for the three and six months ended June 30, 2015 and provided an update on recent corporate developments.
Summary
Global net product sales for PROCYSBI® (cysteamine bitartrate) delayed-release capsules were $23.3 million for the second quarter ended June 30, 2015 compared to $16.3 million for the same period in 2014, representing a growth of 43% year over year.
Raptor reported a net loss on a GAAP basis of $13.9 million for the second quarter, or $0.17 per share.
Cash and cash equivalents were $193.0 million while short-term investments were $27.5 million as of June 30, 2015. Cash balances were bolstered by $92.0 million in net proceeds from an underwritten public offering completed in April.
Raptor affirms its 2015 financial guidance of global net product sales for PROCYSBI of between $80 and $90 million and non-GAAP operating expenses, excluding cost of sales and non-cash stock-based compensation expense, of between $115 and $125 million.
“We are pleased with the commercial performance of PROCYSBI this quarter, which exceeded our expectations,” said Julie Anne Smith, President and CEO of Raptor Pharmaceutical Corp. “We remain focused on creating additional shareholder value with the continued growth of PROCYSBI and new indications for RP103 in Huntington’s disease, pediatric NASH and mitochondrial diseases. I look forward to updating you on our progress throughout the rest of the year.”
Second 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 further discussion on this subject.
Net Product Sales
PROCYSBI global net product sales for the second quarter of 2015 were $23.3 million compared to $16.3 million for the second quarter of 2014. Revenue growth in the second quarter of 2015 was driven by further market penetration in the U.S., Germany and other European and ex-U.S. territories. In the quarter, the company recorded sales in nine countries: U.S., Germany, Austria, Switzerland, Norway, Denmark, Brazil, Israel and Slovenia.
Cost of Sales
Cost of sales were $2.6 million for the second quarter of 2015, compared to $1.0 million for the second quarter of 2014. Cost of sales were higher in the second quarter of 2015 than in the second quarter of 2014 due to increases in both product sales and inventory reserves.
Research & Development (R&D)
R&D expenses were $11.9 million for the second quarter of 2015 compared to $11.1 million for the second quarter of 2014. The increase was primarily due to increases in preclinical studies and lab services on research and discovery projects.
Selling, General and Administrative (SG&A)
SG&A expenses were $17.8 million for the second quarter of 2015 compared to $13.3 million for the second quarter of 2014. The increase mainly resulted from increased staffing and promotional support for commercial operations of PROCYSBI worldwide, corporate expenses and professional fees, and modifications to a non-employee director’s stock awards.
Interest Expense
Interest expense was $4.8 million for the second quarter of 2015 compared to $3.5 million for the second quarter of 2014. The increase was primarily attributable to interest on an increase of $10.0 million of principal in Raptor’s loan agreement with HealthCare Royalty Partners and to interest due on $60.0 million in convertible notes, with both increases effective July 1, 2014.
Net Loss
GAAP net loss in the second quarter of 2015 was $13.9 million, or $0.17 per share, compared to a net loss of $12.7 million, or $0.20 per share, in the second quarter of 2014.
Non-GAAP net loss, which excludes non-cash stock-based compensation expense, for the second quarter of 2015 was $9.6 million, or $0.12 per share, compared to a Non-GAAP net loss of $9.4 million, or $0.15 per share, in the second quarter of 2014.
Cash, Cash Equivalents and Short-Term Investments
Raptor ended the second quarter of 2015 with $193.0 million in cash and cash equivalents and $27.5 million in short-term investments.
2015 Financial Guidance
- Raptor reiterates its 2015 global net product sales guidance for PROCYSBI of $80 to $90 million.
- The company reconfirms full-year non-GAAP operating expense guidance range of $115 million to $125 million, which excludes cost of sales and non-cash stock-based compensation expense.
Product and Pipeline Updates
PROCYSBI for Nephropathic Cystinosis
- PROCYSBI is currently commercially available to patients in the U.S., where it is the market leader in nephropathic cystinosis. PROCYSBI is also commercially available in Europe and several emerging markets where uptake continues to grow. In addition, during the second quarter of 2015, Raptor recognized on a named patient basis its first deliveries to Israel and Slovenia. Raptor expects to make further shipments in new territories during the second half of 2015.
- The Prescription Drug User Fee Act (PDUFA) date for the FDA’s decision on the potential label expansion for PROCYSBI to include nephropathic cystinosis patients aged 2-6 years is August 14, 2015.
RP103 for Huntington’s Disease (HD)
- An update on the regulatory pathway in Huntington’s disease, along with data from the 36-month time-point for the RP103 CYST-HD study is expected in the fourth quarter of 2015.
RP103 for Pediatric Non-alcoholic Steatohepatitis (NASH)
- All enrolled patients have completed the Week 52 visit in the Phase 2b pediatric NASH (CyNCh) trial, with 86% of randomized subjects completing 52 weeks of treatment and receiving their end-of-study liver biopsy.
- Evaluation of all final biopsies by a blinded central reader has occurred and data is expected in the third quarter of 2015, provided the National Institute of Diabetes and Digestive Kidney Diseases (NIDDK) completes its data analysis as expected.
RP103 for Mitochondrial Diseases
- The Phase 2 RP103 study for mitochondrial diseases, including Leigh syndrome, remains ongoing. More than 50% of the planned total number of patients have been enrolled in the study.
- The first interim analysis occurred after 4 patients completed 24 weeks of treatment and the trial will continue as planned. There were no safety signals that would impact trial continuation.
- Raptor expects to conduct a second interim analysis after 12 patients have completed 24 weeks of treatment, which is now expected to occur in the first quarter of 2016 based on the pace of enrollment.
Anticipated Upcoming Milestones
- August 14, 2015 – PDUFA date for label expansion for PROCYSBI to include nephropathic cystinosis patients aged 2-6 years
- 3Q 2015 – RP103 Phase 2b CyNCh data in pediatric NASH
- 4Q 2015 – 36-month data from the RP103 Phase 2/3 CYST-HD study in Huntington’s disease
- 4Q 2015 – Regulatory guidance update regarding the clinical development and regulatory pathway of RP103 in Huntington’s disease
Conference Call and Webcast Information
Raptor will conduct a conference call and live audio webcast at 4:30 p.m. ET (1:30 p.m. PT) today. The live call may be accessed by dialing (877) 710-6201 for domestic callers or (616) 548-5611 for international callers and using the conference ID number 87590408. A live webcast of the conference call will be available online from the investor relations section of the company website at www.raptorpharma.com. After the call, a webcast replay will be available on the Raptor website for 90 days while a telephone replay will be available for 5 days. This can be accessed by dialing (855) 859-2056 for domestic callers, or (404) 537-3406 for international callers, and using the conference ID number 87590408.
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