SAN DIEGO, March 2, 2015 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the fourth quarter and full year ended December 31, 2014. Financial highlights for the fourth quarter include revenues of $30.4 million and a net loss of $5.3 million, or $0.04 per share. This compares to revenues of $12.5 million and a net loss of $22.0 million, or $0.19 per share, for the fourth quarter of 2013. Financial highlights for the full year 2014 include revenues of $75.3 million and a net loss of $68.4 million, or $0.56 per share. This compares to revenues of $54.8 million and a net loss of $83.5 million, or $0.74 per share, in the prior year.
“This has been a remarkable year of growth and progress for Halozyme. We achieved record revenues for the quarter and year, received the first U.S. approval and launch of a Biologics License Application utilizing our ENHANZE technology with the approval of Baxter’s HYQVIA, and announced the launch of our third partnered product, MabThera® SC in Europe,” said Dr. Helen Torley, President and Chief Executive Officer. “With continued projected growth in our royalty revenues, multiple near-term milestones for our investigational new drug PEGPH20, and a strong financial position, we believe we are well-positioned to grow shareholder value in 2015 and beyond.”
Fourth Quarter 2014 Highlights and Subsequent Events
- Announced interim results of Study 202 evaluating investigational PEGPH20 with gemcitabine and ABRAXANE® (nab-paclitaxel) in Stage IV pancreatic cancer patients: In January 2015, Halozyme announced interim data from Study 202. Data reported included data from 146 patients enrolled in Stage 1 of the Phase 2 trial (Study 202), the population enrolled prior to the April 2014 clinical hold and included data on progression-free survival and overall response rate. In a retrospectively defined sub-population of patients with tumors that accumulated high levels of hyaluronan (HA), there was a statistically significant improvement in the median progression-free survival (HR=0.38; p=0.031) in patients treated with PEGPH20, ABRAXANE® (nab-paclitaxel) and gemcitabine (PAG) (9.2 months) vs. treatment with ABRAXANE® (nab-paclitaxel) and gemcitabine (AG) alone (4.3 months). The overall response rate was also statistically significant at 71% vs. 29% for high HA patients treatment with PAG compared to AG (p=0.016). Evaluating the most frequently reported treatment-emergent adverse events, the overall incidence was similar between treatment arms with the exception of a higher incidence of peripheral edema, muscle spasms and neutropenia in patients treated with PAG. In addition, the rate of thromboembolic events was 41.9% compared to 24.6% in the PAG vs. AG arm with the majority being Grade 2 or 3. In Q1 2015, the Company plans to discuss these data and the benefit:risk of PEGPH20 and its plans to initiate a registration trial with the FDA.
- Initiated Phase 1b/2 clinical trial of PEGPH20 in non-small cell lung cancer (NSCLC): In January 2015, the Company began patient screening in an international Phase 1b/2 randomized clinical trial (PRIMAL) of our investigational new drug PEGPH20 as a second-line therapy for patients with locally advanced and metastatic NSCLC.
- Record quarterly revenues of $30.4 million, including royalty revenues of $4.0 million representing approximately 40% growth from third quarter: Reported $30.4 million in revenues in the fourth quarter, which reflects record quarterly revenues for the Company. Royalty revenues of $4.0 million represent July to September 2014 sales as a result of the one quarter lag in royalty reports. The Company anticipates first quarter 2015 royalty revenues to be in the range of $6 million to $7 million, which represents October to December 2014 sales.
- Global collaboration with Janssen to develop and commercialize subcutaneous products using ENHANZE technology: Halozyme entered into a worldwide collaboration and license agreement with Janssen Biotech, Inc. (Janssen) for the purpose of developing and commercializing products combining proprietary Janssen compounds with Halozyme’s ENHANZE technology. Halozyme received an initial payment of $15 million in December 2014. The agreement provides for milestone payments totaling up to $566 million, in addition to royalty payments based on net sales of products using ENHANZE technology.
- Baxter launched HYQVIA in the U.S. for adult patients with primary immunodeficiency: In October, Baxter and Halozyme announced the launch and first shipments of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], for adult patients with primary immunodeficiency, in the United States.
- PEGPH20 granted Orphan Drug Designation for pancreatic cancer: In October, the FDA granted Orphan Drug designation for PEGPH20 for the treatment of pancreatic cancer. In December, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, also designated PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer.
- U.S. patent issued for companion diagnostic for PEGPH20: In October, U.S. Patent No. 8,846,034 issued claiming methods for selecting a subject for treatment of a hyaluronan-associated disease with an anti-hyaluronan agent, such as PEGPH20, as well as diagnostic agents for the detection and quantification of hyaluronan in a biological sample in patients.
Fourth Quarter and Full Year 2014 Financial Highlights
- Revenues for the fourth quarter of 2014 were $30.4 million, compared to $12.5 million for the fourth quarter of 2013. Revenues in the fourth quarter included $5.9 million in product sales of bulk rHuPH20 for use in manufacturing Roche’s collaboration products, $4.1 million in Hylenex® recombinant (hyaluronidase human injection) product sales, $4.0 million in royalty revenue from sales of products under our collaborations and a $15 million licensing fee from Janssen. Revenues for the full year were $75.3 million compared to $54.8 million in the previous year.
Research and development expenses for the fourth quarter of 2014 were $19.7 million, compared to $20.9 million for the fourth quarter of 2013.
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