Date of Report (Date of Earliest Event Reported): | August 7, 2013 |
Delaware | 001-32335 | 88-0488686 | |
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | |
11388 Sorrento Valley Road, San Diego, California | 92121 |
(Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: | (858) 794-8889 |
Exhibit No. | Description |
99.1 | Press release dated August 7, 2013 |
HALOZYME THERAPEUTICS, INC. | ||||
August 7, 2013 | By: | /s/ Jean Liu | ||
Name: | Jean Liu | |||
Title: | Vice President, General Counsel & Secretary |
Exhibit No. | Description | |
99.1 | Press release dated August 7, 2013 |
• | EU Regulatory Progress for Herceptin SC and HyQvia: The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion to Roche for the use of a subcutaneous formulation of Herceptin (trastuzumab) as treatment for patients with HER2-positive breast cancer. In addition, the European Commission granted Baxter marketing authorization in all European Union member states for the use of HyQvia as replacement therapy for adult patients with primary and secondary immunodeficiencies. Baxter launched HyQvia into the first EU country in July and plans to introduce the product into additional EU countries over the coming quarters. The first commercial sale of HyQvia in Europe triggered a $4 million milestone payment to Halozyme. |
• | Positive Clinical Results and New Study Underway for PEGPH20 in Pancreatic Cancer: Study investigators presented Phase 1b clinical trial results in 28 patients evaluating PEGPH20 as a first-line therapy for patients with stage IV metastatic pancreatic cancer at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting. Results showed a 42% response rate for those treated at therapeutic doses of PEGPH20 with gemcitabine, and proof of mechanism for a companion diagnostic with this novel agent. Based upon encouraging Phase 1b results, a Phase 2 multicenter, randomized clinical trial evaluating PEGPH20 for the treatment of stage IV pancreatic cancer began in April. Approximately 124 patients are expected to participate in the study and receive gemcitabine and nab-paclitaxel either with or without PEGPH20. The primary endpoint is progression free survival over 12 months with secondary endpoints of |
• | Clinical Progress for Hylenex Insulin Pump Phase 4 Program in Type 1 Diabetes: The enrollment target of 400 patients has been met with over 440 patients now projected at full enrollment in the CONSISTENT 1 clinical trial, a Phase 4 study designed to evaluate the treatment effect of Hylenex in adults with type 1 diabetes taking rapid analog insulin delivered by pumps. The primary endpoints include metabolic and safety outcomes, including detailed immunogenicity analysis. Results from a smaller Phase 4 clinical pharmacology study in people with type 1 diabetes were presented in June 2013 at the 73rd Scientific Sessions of the American Diabetes Association. Data from the study indicate that Hylenex administered once at the time of each infusion set change provided a consistent, and more rapid insulin absorption and action profile throughout three days of continuous use compared to analog insulin. The data further indicate that this profile improved glucose response to meal challenges and allowed twice as many subjects to consistently reach clinical targets for post prandial glucose control. |
• | Completion of Dosing and Presentation of Encouraging Interim Results for HTI-501: Interim results from a Phase 1/2 clinical trial evaluating HTI-501 for use in aesthetic dermatology were available for the primary 28 day observation endpoint in 12 of the planned 34 evaluable patients. Results indicate pharmacologic activity at the primary 28 day observation endpoint. This trial is being conducted outside the U.S. in healthy adult females with cellulite, known medically as edematous fibrosclerotic panniculopathy. The interim results were presented at the 9th Annual World Congress of Cosmetic Dermatology. The study is now fully enrolled and the last patient was dosed in July. |
• | ViroPharma discontinued a Phase 2 study of subcutaneous Cinryze (C1 Esterase Inhibitor [Human]) with recombinant human hyaluronidase (rHuPH20) following discussions with the FDA as a precaution related to the emergence of an unexpected incidence and titer of non-neutralizing anti-rHuPH20 antibodies in a number of patients with the formulation being used in this study. These antibodies have not been associated with any adverse clinical effects. |
• | Revenues for the second quarter of 2013 were $14.5 million, compared to $7.8 million for the second quarter of 2012. Revenues in the second quarter of 2013 included $8.7 million in revenue from research and development reimbursements from partners primarily related to manufacturing activities to support launches by our partners. Revenues for the six months were $26.3 million compared to $15.2 million in the year ago period. |
• | Research and development expenses for the second quarter of 2013 were $28.0 million, compared with $16.1 million for the second quarter of 2012. This is primarily due to an increase in manufacturing activities to support partner launches and an increase in clinical trial activities. |
• | Selling, general and administrative expenses for the second quarter of 2013 were $7.3 million, compared to $5.6 million for the second quarter of 2012. The increase was mainly due to an increase in commercial activities. |
• | The net loss for the second quarter of 2013 was $22.9 million, or $0.20 per share, compared with a net loss for the second quarter of 2012 of $14.0 million, or $0.13 per share. The net loss for the six months to date totaled $42.2 million or $0.38 per share compared to a net loss of $29.1 million or $0.27 per share for the first six months of 2012. |
• | Cash, cash equivalents and marketable securities were $76.0 million at June 30, 2013, compared with $87.4 million at March 31, 2013 and $99.5 million at December 31, 2012. Net cash used in the second quarter of 2013 was approximately $11.4 million. |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||
REVENUES: | |||||||||||||||
Product sales, net | $ | 3,099,853 | $ | 524,942 | $ | 4,608,447 | $ | 712,353 | |||||||
Revenues under collaborative agreements | 11,353,957 | 7,232,233 | 21,678,903 | 14,485,001 | |||||||||||
Total revenues | 14,453,810 | 7,757,175 | 26,287,350 | 15,197,354 | |||||||||||
OPERATING EXPENSES: | |||||||||||||||
Cost of product sales | 1,283,949 | 143,120 | 2,022,920 | 213,881 | |||||||||||
Research and development | 27,990,755 | 16,081,729 | 50,025,192 | 31,972,838 | |||||||||||
Selling, general and administrative | 7,299,754 | 5,580,424 | 14,855,659 | 12,199,131 | |||||||||||
Total operating expenses | 36,574,458 | 21,805,273 | 66,903,771 | 44,385,850 | |||||||||||
OPERATING LOSS | (22,120,648 | ) | (14,048,098 | ) | (40,616,421 | ) | (29,188,496 | ) | |||||||
Investment and other income | 58,132 | 26,979 | 113,120 | 48,196 | |||||||||||
Interest expense | (848,995 | ) | — | (1,696,579 | ) | — | |||||||||
NET LOSS | $ | (22,911,511 | ) | $ | (14,021,119 | ) | $ | (42,199,880 | ) | $ | (29,140,300 | ) | |||
Basic and diluted net loss per share | $ | (0.20 | ) | $ | (0.13 | ) | $ | (0.38 | ) | $ | (0.27 | ) | |||
Shares used in computing basic and diluted net loss per share | 112,486,211 | 112,063,665 | 112,451,693 | 109,826,589 |
June 30, 2013 | December 31, 2012 | ||||||
(Unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 27,927,551 | $ | 99,501,264 | |||
Marketable securities, available-for-sale | 48,082,636 | — | |||||
Accounts receivable, net | 10,831,828 | 15,703,087 | |||||
Inventories | 2,466,999 | 2,670,696 | |||||
Prepaid expenses and other assets | 11,111,833 | 12,752,888 | |||||
Total current assets | 100,420,847 | 130,627,935 | |||||
Property and equipment, net | 4,576,506 | 3,700,462 | |||||
Prepaid expenses and other assets | 1,889,985 | — | |||||
Restricted cash | 500,000 | 400,000 | |||||
Total Assets | $ | 107,387,338 | $ | 134,728,397 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 7,480,982 | $ | 2,271,689 | |||
Accrued expenses | 15,289,431 | 7,783,447 | |||||
Deferred revenue, current portion | 6,419,681 | 8,891,017 | |||||
Current portion of long-term debt, net | 3,643,156 | — | |||||
Total current liabilities | 32,833,250 | 18,946,153 | |||||
Deferred revenue, net of current portion | 33,681,996 | 34,954,966 | |||||
Long-term debt, net | 26,075,507 | 29,661,680 | |||||
Lease financing obligation | 2,100,000 | 1,450,000 | |||||
Deferred rent, net of current portion | 874,208 | 861,879 | |||||
Other long-term liability | 678,700 | — | |||||
Stockholders’ equity: | |||||||
Common stock | 113,286 | 112,709 | |||||
Additional paid-in capital | 351,843,228 | 347,314,658 | |||||
Accumulated other comprehensive loss | (39,309 | ) | — | ||||
Accumulated deficit | (340,773,528 | ) | (298,573,648 | ) | |||
Total stockholders’ equity | 11,143,677 | 48,853,719 | |||||
Total Liabilities and Stockholders’ Equity | $ | 107,387,338 | $ | 134,728,397 |
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