Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced today its financial results for the second quarter ended June 30, 2014. financial Highlights for the second quarter include revenues of $ 18.4 million and a net loss of $ 16.3 million, or 0.13 $ per share. This compares to revenues of $ 14.5 million and a net loss of $ 22.9 million, or $ 0.20 per share for the second quarter of 2013.
"It was quarter significant progress in our proprietary programs and partners, "said Dr. Helen Torley, President and CEO. "We are pleased to have resolved the clinical hold and resume patient enrollment and dosing in our Phase 2 clinical trial for PEGPH20 in patients with pancreatic cancer. The launch of MabThera ® SC, ramp sales continue Herceptin ® SC in Europe, and the recent vote by the Advisory Blood Products Committee (CBCP) of the Food and Drug Administration (FDA) that HyQvia Baxter has a favorable benefit to risk profile, continue to validate our own. Enhanze ™ platform, "
Highlights of the second quarter
- patient dosing and registration resumed PEGPH20 clinical program in cancer pancreas for: in June, the FDA removed the clinical hold on patient enrollment and dosing of PEGPH20 in Phase 2 trials ongoing (study 202) evaluating PEGPH20 in patients with cancer pancreatic allowing the study to include in a revised protocol. changes to the study protocol 202 include the additional use of heparin low molecular weight as prophylaxis and modification of inclusion / exclusion criteria to exclude patients who may be at higher risk of thromboembolic events. in addition to the more than 100 patients already enrolled in the study, Halozyme plans to include a similar number of additional patients. About 75% of the planned clinical sites received the approval of the independent review boards and the Company foresees the continuation of IRB approval in the coming weeks.
- CONSISTENT 1 test results in type 1 diabetes patients presented in the poster late breaker ADA: 1 test evaluates COMPLIANT Hylenex ® recombinant and a new formulation of Hylenex currently under review by the FDA when used as pretreatment insulin infusion site in patients with type 1 diabetes receiving insulin infusion subcutaneous continuous with no pretreatment. The data reported in a poster presentation at 74 e Scientific Sessions of the American Diabetes Association in San Francisco showed that the study met its primary endpoint of non-inferiority in A1C six months between the use of Hylenex and the new formulation of Hylenex compared to no pretreatment. The poster also presented data indicating that there was a potential reduction in hypoglycemic event rates associated with the use of Hylenex formulations in comparison with no pretreatment.
- MabThera ® SC launched by Roche in the first EU market: in June 2014, Roche launched the European launch its new subcutaneous (SC) formulation of MabThera (rituximab) using recombinant human hyaluronidase Halozyme (rHuPH20) for the treatment of patients with follicular lymphoma and diffuse large cell lymphoma B. the wording previously approved MabThera is administered by intravenous infusion that takes about 2.5 hours. The new formulation MabThera SC can be administered subcutaneously in about 5 minutes and is presented as a fixed dose, ready to use solution, 1400 mg, which shortens the pharmacy preparation time and reduces overall impact on hospital resources. The first commercial launch in the EU triggered a milestone payment of $ 5 million to Halozyme.
for the second quarter and six months 2014 Financial Highlights
- Revenues for the second quarter 2014 were $ 18.4 million compared to $ 14.5 million for the second quarter of 2013. turnover in the second quarter included $ 6.0 million in sales of rHuPH20 bulk products for use in the manufacture of Roche products, revenue $ 7.2 million collaboration, $ 3.0 in Hylenex product sales, and $ 1.7 million in royalty income from sales of products under our collaborations ®. Revenues for the six months was $ 30.4 million compared to $ 26.3 million for the period 2013
- The costs of research and development corresponding to the second quarter 2014 were was $ 18.6 million, compared to $ 28.0 million in the second quarter of 2013. the decrease was primarily due to lower manufacturing costs, which are now included in the cost of product sales. spending
- selling, general and administrative for the second quarter 2014 were $ 8.8 million compared to $ 7.3 million for the second quarter of 2013. The increase was primarily due to increased compensation costs and professional fees and patent.
- net loss for the second quarter 2014 was $ 16.3 million, or $ 0.13 per share, compared to a net loss for the second quarter of 2013 of $ 22.9 million, or 0 $ 20 per share. The net loss for the six months to date was $ 42.8 million or $ 0.35 per share compared to a net loss of $ 42.2 million or $ 0.38 per share for the first six months of 2013 .
- cash, cash equivalents and marketable securities were $ 147.6 million at June 30, 2014 compared to $ 164.5 million at March 31, 2014. net cash used in the second quarter 2014 was approximately $ 16.9 million.