Date of Report (Date of Earliest Event Reported): | May 9, 2017 |
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 | May 9, 2017 |
HALOZYME THERAPEUTICS, INC. | ||||
May 9, 2017 | By: | /s/ Harry J. Leonhardt, Esq. | ||
Name: | Harry J. Leonhardt, Esq. | |||
Title: | Senior Vice President, General Counsel, Chief Compliance Officer and Corporate Secretary |
Exhibit No. | Description | ||
99.1 | Press release dated | May 9, 2017 |
• | Acceptance of Halozyme’s Phase 2 randomized HALO-202 study data for an oral presentation at the ASCO Annual Meeting. The presentation will expand on the topline results shared in January with additional data from the study as of December 2016. |
• | Enrollment tracking to plan in HALO-301, the company’s Phase 3 study of pancreas cancer patients at over 200 global sites in 22 countries. |
• | Progressing in the dose expansion phase of the ongoing Phase 1b clinical study evaluating PEGPH20 in combination with KEYTRUDA® (pembrolizumab) in relapsed non-small cell lung and gastric cancer patients. Enrollment is progressing to plan and may enable Halozyme to report response rate data by the end of the year, depending on the pace of enrollment and time to response. |
• | Presenting data showing PEGPH20 increases immune response and effectiveness of immunotherapies in preclinical animal models at the American Association of Cancer Research annual meeting. The research showed a significant increase in the accumulation of cancer-fighting CD8+ T cells in mice treated with PEGPH20, and that PEGPH20 increased the effectiveness of an anti-PD-L1 therapy by 411 percent compared to anti-PD-L1 alone as measured by tumor growth inhibition in an HA-rich mouse model. |
• | Announcing an Oncologic Drug Advisory Committee of the U.S. Food and Drug Administration voted 11 to 0 that the benefit/risk of rituximab/hyaluronidase for subcutaneous injection was favorable for patients in the proposed indications of follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia. The FDA action date is June 26. Analysts estimate rituxumab sales in oncology indications in the United States were approximately $3 billion in 2016. |
• | Advancing the development of multiple products using Halozyme’s ENHANZE® technology. Roche continues in its ongoing Phase 1 study to examine the combination of Herceptin SC and a subcutaneous formulation of Perjeta using ENHANZE®, including investigation into whether a single injection of the combination can be achieved, potentially providing a significant convenience for patients. |
• | Revenue for the first quarter was $29.6 million compared to $42.5 million for the first quarter of 2016. The year-over-year decrease was driven by $15.5 million received in license and milestone payments from Lilly, AbbVie and Pfizer in the first quarter of 2016, partially offset by increases in royalties from partner sales of Herceptin® SC, MabThera® SC and HYQVIA®, and research and development reimbursements from ENHANZE® partners. Revenue for the first quarter included $14 million in royalties, an increase of 23 percent from the prior-year period, $8.2 million in sales of bulk rHuPH20 primarily for use in manufacturing collaboration products and $3.2 million in HYLENEX® recombinant (hyaluronidase human injection) product sales. |
• | Research and development expenses for the first quarter were $36.9 million, compared to $40.1 million for the first quarter of 2016. The decrease was driven by drug product purchases for the HALO-301 study as well as one-time costs related to companion diagnostic development. |
• | Selling, general and administrative expenses for the first quarter were $12.6 million, compared to $10.8 million for the first quarter of 2016. The increase was primarily due to personnel expenses, including stock compensation, for the period. |
• | Net loss for the first quarter was $32.9 million, or $0.26 per share, compared to net loss in the first quarter of 2016 of $19.8 million, or $0.16 per share. |
• | Cash, cash equivalents and marketable securities were $179 million at March 31, 2017, compared to $205 million at December 31, 2016. |
• | Net revenue of $115 million to $130 million; |
• | Operating expenses of $240 million to $250 million; |
• | Operating cash burn of $75 million to $85 million; and |
• | Year-end cash balance of $110 million to $125 million. |
Three Months Ended | ||||||||
March 31, | ||||||||
2017 | 2016 | |||||||
Revenues: | ||||||||
Product sales, net | $ | 11,434 | $ | 12,940 | ||||
Royalties | 13,982 | 11,387 | ||||||
Revenues under collaborative agreements | 4,152 | 18,172 | ||||||
Total revenues | 29,568 | 42,499 | ||||||
Operating expenses: | ||||||||
Cost of product sales | 7,544 | 7,762 | ||||||
Research and development | 36,935 | 40,100 | ||||||
Selling, general and administrative | 12,615 | 10,806 | ||||||
Total operating expenses | 57,094 | 58,668 | ||||||
Operating loss | (27,526 | ) | (16,169 | ) | ||||
Other income (expense): | ||||||||
Investment and other income, net | 287 | 229 | ||||||
Interest expense | (5,448 | ) | (3,876 | ) | ||||
Net loss before income taxes | (32,687 | ) | (19,816 | ) | ||||
Income tax expense | 210 | — | ||||||
Net loss | $ | (32,897 | ) | $ | (19,816 | ) | ||
Net loss per share: | ||||||||
Basic and diluted | $ | (0.26 | ) | $ | (0.16 | ) | ||
Shares used in computing net loss per share: | ||||||||
Basic and diluted | 128,615 | 127,615 |
March 31, 2017 | December 31, 2016 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 45,188 | $ | 66,764 | ||||
Marketable securities, available-for-sale | 133,797 | 138,217 | ||||||
Accounts receivable, net | 12,452 | 15,680 | ||||||
Inventories | 14,290 | 14,623 | ||||||
Prepaid expenses and other assets | 16,627 | 21,248 | ||||||
Total current assets | 222,354 | 256,532 | ||||||
Property and equipment, net | 3,741 | 4,264 | ||||||
Prepaid expenses and other assets | 172 | 219 | ||||||
Restricted cash | 500 | 500 | ||||||
Total assets | $ | 226,767 | $ | 261,515 | ||||
LIABILITIES AND STOCKHOLDERS’ DEFICIT | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 3,079 | $ | 3,578 | ||||
Accrued expenses | 24,935 | 28,821 | ||||||
Deferred revenue, current portion | 4,093 | 4,793 | ||||||
Current portion of long-term debt | 29,601 | 17,393 | ||||||
Total current liabilities | 61,708 | 54,585 | ||||||
Deferred revenue, net of current portion | 38,802 | 39,825 | ||||||
Long-term debt, net | 184,430 | 199,228 | ||||||
Other long-term liabilities | 326 | 358 | ||||||
Stockholders’ deficit: | ||||||||
Common stock | 130 | 130 | ||||||
Additional paid-in capital | 559,659 | 552,737 | ||||||
Accumulated other comprehensive loss | (49 | ) | (6 | ) | ||||
Accumulated deficit | (618,239 | ) | (585,342 | ) | ||||
Total stockholders’ deficit | (58,499 | ) | (32,481 | ) | ||||
Total liabilities and stockholders’ deficit | $ | 226,767 | $ | 261,515 |