Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported 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.
"This was a quarter of strong progress across our proprietary and partner programs," stated Dr. Helen Torley, President and Chief Executive Officer. "We are pleased to have resolved the clinical hold and to resume patient enrollment and dosing in our Phase 2 clinical trial for PEGPH20 in patients with pancreatic cancer. The launch of MabThera® SC, the continued sales ramp of Herceptin® SC in Europe, and the recent vote by the Blood Products Advisory Committee (BPAC) of the U.S. Food and Drug Administration (FDA) that Baxter's HyQvia has a favorable benefit to risk profile, continue to validate our proprietary Enhanze™ platform."
Second Quarter Highlights
- Patient dosing and enrollment resumed for PEGPH20 clinical program in pancreatic cancer: In June, the U.S. FDA removed the clinical hold on patient enrollment and dosing of PEGPH20 in the ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer permitting the study to resume under a revised protocol. Modifications to the Study 202 protocol include the added use of low-molecular weight heparin as a prophylaxis and the modification of the inclusion/exclusion criteria to exclude patients who may be at higher risk of thromboembolic events. In addition to the over 100 patients already enrolled in the trial, Halozyme plans to enroll a similar number of additional patients. Approximately 75% of the anticipated clinical sites have received independent review board approvals and the Company anticipates continued IRB approvals in the coming weeks.
- CONSISTENT 1 trial results in type 1 diabetes patients presented in late-breaker poster at ADA: The CONSISTENT 1 trial is evaluating Hylenex® recombinant and a new formulation of Hylenex currently under FDA review when used as pretreatment of the insulin infusion site in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion in comparison to no pre-treatment. Data reported in a poster presentation at the 74th Scientific Sessions of the American Diabetes Association in San Francisco showed that the study achieved its primary endpoint of non-inferiority for A1C at six months between the use of Hylenex and the new formulation of Hylenex in comparison to no pre-treatment. The poster also presented data indicating that there was a potential reduction in the rate of hypoglycemic events associated with the use of the Hylenex formulations in comparison to no pre-treatment.
- MabThera® SC launched by Roche in first EU market: In June 2014, Roche initiated the European launch of its new subcutaneous (SC) formulation of MabThera (rituximab) that uses Halozyme's recombinant human hyaluronidase (rHuPH20) for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma. The previously approved formulation of MabThera is delivered by an intravenous infusion which takes approximately 2.5 hours. The new MabThera SC formulation can be administered subcutaneously in approximately 5 minutes and comes as a ready-to-use, fixed dose, 1,400 mg solution, which shortens pharmacy preparation time and reduces the overall impact on hospital resources. The first commercial launch in the EU has triggered a $5 million milestone payment to Halozyme.
Second Quarter and Six Months 2014 Financial Highlights
- Revenues for the second quarter of 2014 were $18.4 million, compared to $14.5 million for the second quarter of 2013. Revenues in the second quarter included $6.0 million in product sales of bulk rHuPH20 for use in manufacturing Roche products, $7.2 million in collaboration revenues, $3.0 million in Hylenex® product sales, and $1.7 million in royalty revenue from sales of products under our collaborations. Revenues for the six months were $30.4 million compared to $26.3 million in the corresponding period of 2013.
- Research and development expenses for the second quarter of 2014 were $18.6 million, compared with $28.0 million for the second quarter of 2013. The decrease was primarily driven by lower manufacturing costs, which are now included in cost of product sales.
- Selling, general and administrative expenses for the second quarter of 2014 were $8.8 million, compared to $7.3 million for the second quarter of 2013. The increase was mainly due to an increase in compensation costs and patent and professional fees.
- The net loss for the second quarter of 2014 was $16.3 million, or $0.13 per share, compared with 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 totaled $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 with $164.5 million at March 31, 2014. Net cash used in the second quarter of 2014 was approximately $16.9 million.
Halozyme Therapeutics, Inc.