Full Press Release Details
SAN DIEGO , Feb. 29, 2016 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO ) today reported financial results for the fourth quarter and full year ended December 31, 2015 , which included a fourth quarter increase in royalty revenue of 136 percent from the prior year period and net income of $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. For the full year, total revenue increased 79 percent to $135.1 million compared to $75.3 million in the prior year.
"We closed 2015 with record progress across both pillars of our strategy and enter 2016 with strong momentum," said Dr. Helen Torley , president and chief executive officer. "In our oncology pillar, an investigational device exemption was submitted to the FDA earlier this month by our partner Ventana for the PEGPH20 companion diagnostic test. We remain on track to dose the first patient in March in our Phase 3 study in pancreatic cancer patients. We are also continuing to evaluate the dose of PEGPH20 in our lung and gastric cancer trials and are preparing for the initiation of the breast cancer trial with our clinical partner Eisai.
"At the same time, our ENHANZE™ platform continues to generate more value than any other time in company history. With royalty revenue growth in the fourth quarter, a newly signed licensing and collaboration agreement with Eli Lilly and four co-formulated products in the clinic, our ENHANZE platform remains a clear differentiator in any market environment."
Fourth Quarter 2015 Highlights and Subsequent Events include:
Fourth Quarter and Full Year 2015 Financial Highlights
Financial Outlook for 2016 For the full year 2016, the company maintains its previously announced guidance of:
Webcast and Conference Call Halozyme will webcast its Quarterly Update Conference Call for the fourth quarter and full year 2015 today, Monday, February 29 at 4:30 p.m. ET / 1:30 p.m. PT . Dr. Helen Torley , president and chief executive officer, will lead the call. The call will be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit http://www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. For those without access to the Internet, the live call may be accessed by phone by calling (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available shortly after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay passcode 11528439.
About Halozyme Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme's lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie and Lilly for its ENHANZE™ drug delivery platform. Halozyme is headquartered in San Diego . For more information visit www.halozyme.com .
Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the Company's future expectations and plans for growth in 2016, the development and commercialization of product candidates and the potential benefits and attributes of such product candidates and expected financial outlook for 2016) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected fluctuations or changes in revenues, including revenues from collaborators, unexpected results or delays in development of product candidates and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 29, 2016 .
Contacts: Jim Mazzola 858-704-8122 [email protected]
Chris Burton 858-704-8352 [email protected]
| Halozyme Therapeutics, Inc. | |||||||
| Condensed Consolidated Statements of Operations | |||||||
| (Unaudited) | |||||||
| (In thousands, except per share amounts) | |||||||
| 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) | |||
| 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 |
| Halozyme Therapeutics, Inc. | |||
| Condensed Consolidated Balance Sheets | |||
| (Unaudited) | |||
| (In thousands) | |||
| December 31, | |||
| 2015 | 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 |
SOURCE Halozyme Therapeutics, Inc.