Full Press Release Details
SAN DIEGO , Nov. 7, 2016 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO ) today reported financial results and recent highlights for the third quarter ended September 30 .
"The third quarter was highlighted by Genentech's BLA filing for rituximab in a subcutaneous formulation using Halozyme's ENHANZE platform in multiple blood cancers, a development that adds to the potential for our royalty revenue and highlights the benefits of our business model," said Dr. Helen Torley , president and chief executive officer. "In our oncology pillar, we continued initiation of our global sites in our phase 3 study of PEGPH20 and are making progress toward dose expansion in our study with Keytruda, all as we anticipate reporting topline results from stage 2 of our HALO-202 study once the data is mature."
Halozyme was recently informed by the independent statistician for the data monitoring committee of its HALO-202 study that progression-free survival data are not yet mature for analysis. As a result, the company now expects the reporting of data may move into 2017, depending on when it is mature for analysis.
Third Quarter 2016 and Recent Highlights include:
Third Quarter 2016 Financial Highlights
Financial Outlook for 2016
For the full year 2016, the company updated and narrowed its financial guidance, now expecting:
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for the third quarter 2016 today, Monday, November 7 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 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) (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 22039188.
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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 7, 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 | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales, net | $ | 13,331 | $ | 10,301 | $ | 39,970 | $ | 32,503 | ||||||||
| Royalties | 13,036 | 8,274 | 36,695 | 21,431 | ||||||||||||
| Revenues under collaborative agreements | 5,486 | 2,205 | 31,023 | 28,896 | ||||||||||||
| Total revenues | 31,853 | 20,780 | 107,688 | 82,830 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of product sales | 9,134 | 6,180 | 25,204 | 20,818 | ||||||||||||
| Research and development | 33,863 | 27,611 | 109,493 | 65,490 | ||||||||||||
| Selling, general and administrative | 11,599 | 10,226 | 33,626 | 29,439 | ||||||||||||
| Total operating expenses | 54,596 | 44,017 | 168,323 | 115,747 | ||||||||||||
| Operating loss | (22,743) | (23,237) | (60,635) | (32,917) | ||||||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income, net | 334 | 78 | 960 | 267 | ||||||||||||
| Interest expense | (5,253) | (1,301) | (14,378) | (3,899) | ||||||||||||
| Net loss before income taxes | (27,662) | (24,460) | (74,053) | (36,549) | ||||||||||||
| Income tax expense | 1,284 | — | 1,584 | — | ||||||||||||
| Net loss | $ | (28,946) | $ | (24,460) | $ | (75,637) | $ | (36,549) | ||||||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | (0.23) | $ | (0.19) | $ | (0.59) | $ | (0.29) | ||||||||
| Shares used in computing net loss per share: | ||||||||||||||||
| Basic and diluted | 128,154 | 126,921 | 127,886 | 126,127 |
| Halozyme Therapeutics, Inc. Condensed Consolidated Balance Sheets (Unaudited) (In thousands) | ||||||||
| September 30, 2016 | December 31, 2015 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 61,207 | $ | 43,292 | ||||
| Marketable securities, available-for-sale | 159,845 | 65,047 | ||||||
| Accounts receivable, net | 17,679 | 32,410 | ||||||
| Inventories | 12,852 | 9,489 | ||||||
| Prepaid manufacturing costs | 14,960 | 16,155 | ||||||
| Prepaid expenses and other assets | 6,062 | 5,379 | ||||||
| Total current assets | 272,605 | 171,772 | ||||||
| Property and equipment, net | 4,407 | 3,943 | ||||||
| Prepaid expenses and other assets | 4,986 | 5,574 | ||||||
| Restricted cash | 500 | 500 | ||||||
| Total assets | $ | 282,498 | $ | 181,789 | ||||
| LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,641 | $ | 4,499 | ||||
| Accrued expenses | 25,733 | 26,792 | ||||||
| Deferred revenue, current portion | 9,892 | 9,304 | ||||||
| Current portion of long-term debt | 12,394 | 21,862 | ||||||
| Total current liabilities | 52,660 | 62,457 | ||||||
| Deferred revenue, net of current portion | 40,849 | 43,919 | ||||||
| Long-term debt, net | 199,803 | 27,971 | ||||||
| Other long-term liability | 1,178 | 4,443 | ||||||
| Stockholders' (deficit) equity: | ||||||||
| Common stock | 129 | 128 | ||||||
| Additional paid-in capital | 545,751 | 525,628 | ||||||
| Accumulated other comprehensive income | 83 | (99) | ||||||
| Accumulated deficit | (557,955) | (482,658) | ||||||
| Total stockholders' (deficit) equity | (11,992) | 42,999 | ||||||
| Total liabilities and stockholders' (deficit) equity | $ | 282,498 | $ | 181,789 |
SOURCE Halozyme Therapeutics, Inc.