Full Press Release Details
SAN DIEGO , May 9, 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 first quarter ended March 31, 2017.
"The first quarter was marked by strong progress in our ongoing clinical studies of PEGPH20 and continued momentum with partners of our ENHANZE ® technology," said Dr. Helen Torley , president and chief executive officer. "Enrollment is progressing to plan in HALO-301, our ongoing Phase 3 study of PEGPH20 in pancreas cancer patients and in the HALO-101 study of PEGPH20 in combination with KEYTRUDA ® in advanced gastric and non-small cell lung cancer patients, supporting the potential for first efficacy data in combination with a PD-1 inhibitor in the fourth quarter. In addition, we are delighted that our Phase 2 HALO-202 study was selected for an oral presentation at the upcoming American Society of Clinical Oncology annual meeting.
"At the same time, the outlook for our ENHANZE ® technology has never been stronger following the unanimous FDA advisory committee in March supporting rituximab SC. Our pipeline of active partner discussions has continued to expand, and while the timing for new ENHANZE ® collaboration agreements is unpredictable, it remains our goal to sign another agreement in 2017."
First Quarter 2017 and Recent Highlights include:
First Quarter 2017 Financial Highlights
Financial Outlook for 2017
For 2017, the company reiterated its financial guidance of:
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for the first quarter of 2017 today, Tuesday, May 9 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 22142823.
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 technology. 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 9, 2017.
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 | ||||||||
| 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 |
| Halozyme Therapeutics, Inc. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (Unaudited) | ||||||||
| (In thousands) | ||||||||
| 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 |
SOURCE Halozyme Therapeutics, Inc.