Full Press Release Details
SAN DIEGO , Feb. 28, 2017 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO ), a biotechnology company developing novel oncology and drug-delivery therapies, today reported financial results and recent highlights for the fourth quarter and full year ended December 31, 2016 .
"We exited 2016 in a strong position through the benefit of our differentiated business model and having made substantial progress across both of our value-creating pillars," said Dr. Helen Torley , president and chief executive officer. "The positive Phase 2 data we reported last month affirms our conviction in PEGPH20, our lead investigational oncology drug, and supports our ongoing Phase 3 study in pancreas cancer patients. We have made strong progress initiating global sites in the Phase 3 study and see momentum building in the number of patients we are screening.
"Our ENHANZE™ platform remains an important value driver as royalty revenue demonstrated yet another quarter of robust growth, and exceeded $50 million for the year. With positive data presented by Genentech and Janssen at the American Society of Hematology annual meeting for their ENHANZE-partnered programs and a recent BLA filing in the U.S. by Genentech, we remain very encouraged by the royalty growth potential from current and new products over the long term."
Fourth Quarter 2016 and Recent Highlights include:
Fourth Quarter and Full Year 2016 Financial Highlights
Financial Outlook for 2017
For 2017, the company reiterated and updated the cash portions of its financial guidance, now expecting:
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for the fourth quarter and full year 2016 today, Tuesday, February 28 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. The call may also be accessed at (877) 410-5657 (domestic callers) (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 15609911.
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 2017, the development and commercialization of product candidates, including clinical trial patient enrollment projections and future development activities of our collaboration partners, the potential benefits and attributes of such product candidates and expected financial outlook for 2017) 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, including delays in clinical trial patient enrollment and development activities of our collaboration partners, 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 28, 2017 .
| Halozyme Therapeutics, Inc. | ||||||||||||||||
| Condensed Consolidated Statements of Operations | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| (In thousands, except per share amounts) | ||||||||||||||||
| Three Months Ended | For the Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales, net | $ | 13,422 | $ | 13,579 | $ | 53,392 | $ | 46,082 | ||||||||
| Royalties | 14,289 | 9,544 | 50,984 | 30,975 | ||||||||||||
| Revenues under collaborative agreements | 11,292 | 29,104 | 42,315 | 58,000 | ||||||||||||
| Total revenues | 39,003 | 52,227 | 146,691 | 135,057 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of product sales | 8,002 | 8,427 | 33,206 | 29,245 | ||||||||||||
| Research and development | 41,349 | 27,746 | 150,842 | 93,236 | ||||||||||||
| Selling, general and administrative | 12,227 | 10,589 | 45,853 | 40,028 | ||||||||||||
| Total operating expenses | 61,578 | 46,762 | 229,901 | 162,509 | ||||||||||||
| Operating (loss) income | (22,575) | 5,465 | (83,210) | (27,452) | ||||||||||||
| Other income (expense): | ||||||||||||||||
| Investment and other income, net | 366 | 155 | 1,326 | 422 | ||||||||||||
| Interest expense | (5,599) | (1,302) | (19,977) | (5,201) | ||||||||||||
| Net (loss) income before income taxes | (27,808) | 4,318 | (101,861) | (32,231) | ||||||||||||
| Income tax expense (benefit) | (422) | — | 1,162 | — | ||||||||||||
| Net loss | $ | (27,386) | $ | 4,318 | $ | (103,023) | $ | (32,231) | ||||||||
| Net loss per share: | ||||||||||||||||
| Basic | $ | (0.21) | $ | 0.03 | $ | (0.81) | $ | (0.25) | ||||||||
| Diluted | $ | (0.21) | $ | 0.03 | $ | (0.81) | $ | (0.25) | ||||||||
| Shares used in computing net loss per share: | ||||||||||||||||
| Basic | 128,185 | 127,197 | 127,964 | 126,704 | ||||||||||||
| Diluted | 128,185 | 129,248 | 127,964 | 126,704 |
| Halozyme Therapeutics, Inc. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (Unaudited) | ||||||||
| (In thousands) | ||||||||
| December 31, 2016 | December 31, 2015 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 66,764 | $ | 43,292 | ||||
| Marketable securities, available-for-sale | 138,217 | 65,047 | ||||||
| Accounts receivable, net | 15,680 | 32,410 | ||||||
| Inventories | 14,623 | 9,489 | ||||||
| Prepaid expenses and other assets | 21,248 | 21,534 | ||||||
| Total current assets | 256,532 | 171,772 | ||||||
| Property and equipment, net | 4,264 | 3,943 | ||||||
| Prepaid expenses and other assets | 219 | 5,574 | ||||||
| Restricted cash | 500 | 500 | ||||||
| Total assets | $ | 261,515 | $ | 181,789 | ||||
| LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,578 | $ | 4,499 | ||||
| Accrued expenses | 28,821 | 26,792 | ||||||
| Deferred revenue, current portion | 4,793 | 9,304 | ||||||
| Current portion of long-term debt | 17,393 | 21,862 | ||||||
| Total current liabilities | 54,585 | 62,457 | ||||||
| Deferred revenue, net of current portion | 39,825 | 43,919 | ||||||
| Long-term debt, net | 199,228 | 27,971 | ||||||
| Other long-term liabilities | 358 | 4,443 | ||||||
| Stockholders' (deficit) equity: | ||||||||
| Common stock | 130 | 128 | ||||||
| Additional paid-in capital | 552,737 | 525,628 | ||||||
| Accumulated other comprehensive loss | (6) | (99) | ||||||
| Accumulated deficit | (585,342) | (482,658) | ||||||
| Total stockholders' (deficit) equity | (32,481) | 42,999 | ||||||
| Total liabilities and stockholders' (deficit) equity | $ | 261,515 | $ | 181,789 |
Contacts: Jim Mazzola 858-704-8122 [email protected]
Chris Burton 858-704-8352 [email protected]
SOURCE Halozyme Therapeutics, Inc.