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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Halozyme Therapeutics Incorporated | NASDAQ:HALO | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-1.04 | -2.29% | 44.44 | 42.90 | 45.80 | 45.56 | 43.75 | 45.43 | 1,148,778 | 01:00:00 |
Date of Report (Date of Earliest Event Reported): | February 29, 2016 |
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 February 29, 2016 |
HALOZYME THERAPEUTICS, INC. | ||||
February 29, 2016 | By: | /s/ Laurie D. Stelzer | ||
Name: | Laurie D. Stelzer | |||
Title: | Senior Vice President and Chief Financial Officer |
Exhibit No. | Description | |
99.1 | Press release dated February 29, 2016 |
• | Submitting an investigational device exemption to the FDA for the companion diagnostic test developed with Ventana to prospectively identify patients with high levels of hyaluronan, or HA. |
• | Remaining on track to dose first patient in HALO-301 | Pancreatic study in March 2016, a Phase 3 study to explore PEGPH20 with gemcitabine and ABRAXANE® (nab-paclitaxel) in metastatic pancreatic cancer patients at approximately 200 sites in 20 countries located in North America, Europe, South America and Asia Pacific. |
• | Closing enrollment in HALO-202 | Pancreatic study with 133 patients in Stage 2 (total 279 patients enrolled), the company remains blinded to the efficacy results and continues to project mature progression-free survival data and overall response rate data in the fourth quarter of 2016. |
• | Continuing to explore the pan-tumor potential of PEGPH20, the company made progress towards identifying the maximum tolerated dose of PEGPH20 in its phase 1b/2 PRIMAL study of PEGPH20 plus docetaxel in lung cancer patients, and Phase 1b study of PEGPH20 plus KEYTRUDA® (pembrolizumab) in lung and gastric cancer patients. In addition, Halozyme expects to initiate the study of PEGPH20 plus eribulin in HER2 negative breast cancer patients through a clinical collaboration with Eisai in the second quarter of 2016. |
• | Signing the company’s sixth collaboration and licensing agreement for Halozyme’s proprietary ENHANZE™ technology platform with Eli Lilly for up to five targets, each with potential milestone payments of $160 million. The agreement resulted in a $25 million upfront license fee to Halozyme that was recorded in the fourth quarter. |
• | Earlier this month, dosing the first subject in Pfizer’s Phase 1 clinical trial evaluating the safety, tolerability and pharmacokinetics of bococizumab, an investigational PCSK9 inhibitor developed by Pfizer, Inc. using Halozyme’s ENHANZE™ platform. The initiation of the clinical trial triggered a $1 million milestone payment to Halozyme under the collaboration and license agreement between Halozyme and Pfizer entered into in 2012. |
• | In January, dosing the first subject in AbbVie’s Phase 1 clinical trial evaluating the safety and pharmacokinetics of adalimumab (HUMIRA®) with Halozyme’s ENHANZE™ platform, resulting in a $5 million milestone payment under the collaboration and license agreement between Halozyme and AbbVie entered into in June of 2015. |
• | In the fourth quarter, dosing the first subjects in Pfizer’s Phase 1 clinical trial of rivipansel and Janssen’s Phase 1b clinical trial of daratumumab with Halozyme’s ENHANZE™ platform. |
• | Revenue for the fourth quarter was $52.2 million, compared to $30.4 million for the fourth quarter of 2014, driven primarily by the upfront license fee from Eli Lilly and royalties from partner sales of Herceptin® SC, MabThera® SC and HyQvia®. Revenue for the quarter included $9.5 million in royalties, $9.3 million in sales of bulk rHuPH20 for use in manufacturing collaboration products and $4.3 million in HYLENEX® recombinant (hyaluronidase human injection) product sales. Revenue for the full year was $135.1 million compared to $75.3 million in the previous year. |
• | Research and development expenses for the fourth quarter were $27.7 million, compared to $19.7 million for the fourth quarter of 2014. The planned increases were primarily due to expenses for preclinical and clinical support of PEGPH20. |
• | Selling, general and administrative expenses for the fourth quarter were $10.6 million, compared to $8.4 million for the fourth quarter of 2014. The increase was primarily due to an increase in personnel expenses, including stock compensation, for the period. |
• | Net income for the fourth quarter was $4.3 million, or $0.03 per share, compared to a net loss in the fourth quarter of 2014 of $5.3 million, or $0.04 per share. The net loss for the full year totaled $32.2 million, or $0.25 per share, compared to a net loss of $68.4 million, or $0.56 per share, for 2014. |
• | Cash, cash equivalents and marketable securities were $108.3 million at Dec. 31, compared to $123.7 million at Sept. 30, 2015. Net cash burn during 2015 was approximately $27.3 million. |
• | Net revenues to be in the range of $110 million to $125 million; |
• | Operating expenses to be in the range of $240 million to $260 million; |
• | Cash Flow to be in the range of $35 million to $55 million; and |
• | Year-end cash balance of $140 million to $160 million. |
Three Months Ended | Year Ended | ||||||||||||||
December 31, | December 31, | ||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||
Revenues: | |||||||||||||||
Product sales, net | $ | 13,579 | $ | 10,144 | $ | 46,082 | $ | 37,823 | |||||||
Revenues under collaborative agreements | 29,104 | 16,190 | 58,000 | 28,086 | |||||||||||
Royalties | 9,544 | 4,043 | 30,975 | 9,425 | |||||||||||
Total revenues | 52,227 | 30,377 | 135,057 | 75,334 | |||||||||||
Operating expenses: | |||||||||||||||
Cost of product sales | 8,427 | 6,147 | 29,245 | 22,732 | |||||||||||
Research and development | 27,746 | 19,728 | 93,236 | 79,696 | |||||||||||
Selling, general and administrative | 10,589 | 8,353 | 40,028 | 35,942 | |||||||||||
Total operating expenses | 46,762 | 34,228 | 162,509 | 138,370 | |||||||||||
Operating income (loss) | 5,465 | (3,851 | ) | (27,452 | ) | (63,036 | ) | ||||||||
Other income (expense): | |||||||||||||||
Investment and other income, net | 155 | (45 | ) | 422 | 242 | ||||||||||
Interest expense | (1,302 | ) | (1,378 | ) | (5,201 | ) | (5,581 | ) | |||||||
Net income (loss) | $ | 4,318 | $ | (5,274 | ) | $ | (32,231 | ) | $ | (68,375 | ) | ||||
Net income (loss) per share: | |||||||||||||||
Basic net income (loss) per share | $ | 0.03 | $ | (0.04 | ) | $ | (0.25 | ) | $ | (0.56 | ) | ||||
Diluted net income (loss) per share | $ | 0.03 | $ | (0.04 | ) | $ | (0.25 | ) | $ | (0.56 | ) | ||||
Shares used in computing basic net income (loss) per share: | 127,197 | 124,272 | 126,704 | 122,690 | |||||||||||
Shares used in computing diluted net income (loss) per share: | 129,248 | 124,272 | 126,704 | 122,690 |
December 31, 2015 | December 31, 2014 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 43,292 | $ | 61,389 | |||
Marketable securities, available-for-sale | 65,047 | 74,234 | |||||
Accounts receivable, net | 32,410 | 9,149 | |||||
Inventories | 9,489 | 6,406 | |||||
Prepaid expenses and other assets | 21,534 | 10,143 | |||||
Total current assets | 171,772 | 161,321 | |||||
Property and equipment, net | 3,943 | 2,951 | |||||
Prepaid expenses and other assets | 5,574 | 1,205 | |||||
Restricted cash | 500 | 500 | |||||
Total assets | $ | 181,789 | $ | 165,977 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 4,499 | $ | 3,003 | |||
Accrued expenses | 26,792 | 13,961 | |||||
Deferred revenue, current portion | 9,304 | 7,367 | |||||
Current portion of long-term debt, net | 21,862 | — | |||||
Total current liabilities | 62,457 | 24,331 | |||||
Deferred revenue, net of current portion | 43,919 | 47,267 | |||||
Long-term debt, net | 27,971 | 49,860 | |||||
Other long-term liabilities | 4,443 | 3,167 | |||||
Stockholders’ equity: | |||||||
Common stock | 128 | 126 | |||||
Additional paid-in capital | 525,628 | 491,694 | |||||
Accumulated other comprehensive loss | (99 | ) | (41 | ) | |||
Accumulated deficit | (482,658 | ) | (450,427 | ) | |||
Total stockholders’ equity | 42,999 | 41,352 | |||||
Total liabilities and stockholders’ equity | $ | 181,789 | $ | 165,977 |
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