SAN DIEGO, Nov. 10, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the third quarter ended September 30, 2014. Financial highlights for the third quarter include revenues of $14.6 million and a net loss of $20.3 million, or $0.16 per share. This compares to revenues of $16.0 million and a net loss of $19.3 million, or $0.17 per share, for the third quarter of 2013.
“The third quarter was notable for completion of a review and update to our corporate strategy based on a portfolio assessment. The recent Fast Track and Orphan Drug designations for PEGPH20, new pre-clinical data further supporting the pan-tumor potential for PEGPH20 and strong investigator interest in both pancreatic and lung cancer trials have confirmed this as our priority proprietary product for investment. The growth in the number of approvals for ENHANZE based products and the launch success of Roche’s Herceptin SC affirms our confidence in the growth potential of the ENHANZE platform,” stated Dr. Helen Torley, President and Chief Executive Officer. “Our pursuit of Hylenex® in Type 1 diabetes is a potential opportunity to expand the indication and increase sales of Hylenex. While discussions with the FDA are ongoing, we have learned that the FDA will likely request additional clinical data for a label update translating to potentially higher projected costs and longer time to market than had originally been anticipated. In the ongoing weeks, we intend to continue to seek clarity with FDA on what data will be required, if any. Once we have gained clarity as to the regulatory requirements for a label update, we intend to enter into collaborations with third parties or explore other strategic alternatives in order to exploit this opportunity. I am excited by the opportunity to focus our resources on advancing PEGPH20 and to expand utilization of our ENHANZE platform.”
Third Quarter 2014 Highlights
Royalty revenues of $2.9 million represent over 70% growth from second quarter: Royalty revenues represent April to June sales as a result of the one quarter lag in royalty reports. The Herceptin SC launch is progressing well with approximately 20% market share in the markets launched through October. A notable recent milestone for Herceptin SC is the recent reimbursement approval and launch in France, traditionally one of the largest EU oncology markets.
HYQVIA® approved by the FDA and launched in the U.S.: In September, the U.S. Food and Drug Administration (FDA) approved HYQVIA for the treatment of primary immunodeficiency (PI) in adults and Baxter began commercial introduction of the product on October 20th. HYQVIA is the first subcutaneous immune globulin (IG) treatment approved for PI patients with a dosing regimen requiring only one infusion up to once per month (every three to four weeks) and one injection site per infusion to deliver a full therapeutic dose of IG.
PEGPH20 (PEGylated recombinant human hyaluronidase) received Fast Track and Orphan Drug designation for pancreatic cancer: The FDA has granted Fast Track designation for Halozyme’s program investigating PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of patients with metastatic pancreatic cancer. The FDA Office of Orphan Products Development also granted Orphan Drug status for PEGylated recombinant human hyaluronidase for the treatment of pancreatic cancer which grants this designation to medical products that demonstrate promise for the treatment of rare diseases or conditions.
PEGPH20(PEGylated recombinant human hyaluronidase) enrollment progressing: 42 of 44 sites have received IRB approval for the Study 202 protocol amendment. A total of 25 of the target of approximately 100 new patients have been enrolled to date.
SWOG resumes clinical trial of PEGPH20 in combination with modified FOLFIRINOX for advanced pancreatic cancer: SWOG Cancer Research has resumed patient enrollment and dosing of PEGPH20 in its ongoing Phase 1b/2 clinical trial (S1313). The trial is designed to evaluate PEGPH20 in combination with modified FOLFIRINOX chemotherapy (mFOLFIRINOX) in patients with metastatic pancreatic adenocarcinoma. The study has resumed under a revised protocol approved by the Independent Review Boards at the participating clinical trial sites.
CONSISTENT 1 trial of Hylenex in patients with Type1 diabetes to be ended after first year: While discussions with FDA are ongoing, we have determined that with all patients having completed 12 months on the trial at this time, we do not need additional data contribution from the second year of CONSISTENT 1 and we will be stopping the study.
Second disclosed program under the Halozyme-Pfizer collaboration: Pfizer intends to investigate a subcutaneous formulation using Halozyme’s Enhanze technology with rivipansel. Rivipansel is an investigational compound under evaluation for the treatment of vaso-occlusive crisis in individuals with sickle cell disease.
- Reduction in force of approximately 13% completed in November 2014 to align with strategic priorities: We completed a corporate reorganization to align with strategic priorities. This reorganization resulted in a workforce reduction of 22 employees. We will incur a one-time charge in the fourth quarter of 2014 that will be largely offset by reduced compensation expenses during the quarter.
Third Quarter and Nine Months 2014 Financial Highlights
Revenues for the third quarter of 2014 were $14.6 million, compared to $16.0 million for the third quarter of 2013. Revenues in the third quarter included $5.8 million in product sales of bulk rHuPH20 for use in manufacturing Roche’s collaboration products, $3.6 million in Hylenex product sales, $2.9 million in royalty revenue from sales of products under our collaborations and $2.1 million in collaboration revenues. Revenues for the nine months were $45.0 million compared to $42.3 million for the same period in the previous year.
Research and development expenses for the third quarter of 2014 were $19.9 million, compared to $25.7 million for the third quarter of 2013. The decrease was primarily due to the inclusion in this quarter of manufacturing expenses in cost of product sales instead of research and development expenses as in the prior period last year.
Selling, general and administrative expenses for the third quarter of 2014 were $8.6 million, compared to $8.1 million for the third quarter of 2013. The increase was mainly due to an increase in patent expenses.
The net loss for the third quarter of 2014 was $20.3 million, or $0.16 per share, compared to a net loss for the third quarter of 2013 of $19.3 million, or $0.17 per share. The net loss for the nine months to date totaled $63.1 million, or $0.52 per share, compared to a net loss of $61.5 million, or $0.55 per share, for the first nine months of 2013.
- Cash, cash equivalents and marketable securities were $134.5 million at September 30, 2014, compared to $147.6 million at June 30, 2014. Net cash used in the third quarter of 2014 was approximately $13.1 million.
Webcast and Conference Call
Halozyme will webcast its quarterly update conference call today, November 10, 2014 at 4:30 p.m. EDT/1:30 p.m. PDT. During the call, management will discuss the financial results for the third quarter of 2014 and provide a business update. To listen to the live webcast please visit the “Investors” section of Halozyme’s corporate website at www.halozyme.com. A webcast replay will be available shortly after the call at the same address. To participate by phone, please dial (866) 710-0179 (domestic callers) or (334) 323-7224 (international callers) using passcode 769890.
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