Full Press Release Details
SAN DIEGO , May 10, 2018 /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 .
"Reflecting the enthusiasm and opportunity for competitive differentiation that ENHANZE may provide, in the first quarter we supported our partners in planning for initiation of an unprecedented number of clinical study starts in 2018, including two additional Phase 1 studies that were not included in our forecast at the beginning of the year," said Dr. Helen Torley , president and chief executive officer. "The momentum we have with ENHANZE reinforces our conviction for the approximately $1 billion royalty revenue potential we outlined in January.
"For PEGPH20, we currently project we will achieve the target number of Progression-Free Survival (PFS) events in HALO-301 between December 2018 and February 2019 . Upon achieving the target number of PFS events, final data collection and the steps required for database lock prior to the interim analysis will be initiated. With enrollment at the end of April on track with more than 350 patients, we continue to project approximately 500 patients will have been enrolled by year-end."
First Quarter 2018 and Recent Highlights include:
First Quarter 2018 Financial Highlights
Financial Outlook for 2018
Halozyme reiterated its financial guidance of:
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for the first quarter of 2018 today, Thursday, May 10 at 4:30 p.m. ET / 1:30 p.m. PT . Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme's corporate website and a recording made available following the close of the call. To access the webcast and additional documents related to the call, please visit halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (877) 410-5657 (domestic callers) or (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 68917761.
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 pegvorhyaluronidase alfa (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, Lilly, Bristol-Myers Squibb and Alexion 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 2018, entering into new collaboration agreements, the development and commercialization of product candidates, including timing of clinical trial results announcements and future development and commercial activities of our collaboration partners, the potential benefits and attributes of such product candidates and expected financial outlook for 2018) 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 delays in entering into new collaboration agreements, 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 10, 2018.
| Halozyme Therapeutics, Inc. | ||||||
| Condensed Consolidated Statements of Operations | ||||||
| (Unaudited) | ||||||
| (In thousands, except per share amounts) | ||||||
| Three Months Ended | ||||||
| March 31, | ||||||
| 2018 | 2017 | |||||
| Revenues: | ||||||
| Royalties | $ | 20,944 | $ | 13,982 | ||
| Product sales, net | 6,801 | 11,434 | ||||
| Revenues under collaborative agreements | 3,127 | 4,152 | ||||
| Total revenues | 30,872 | 29,568 | ||||
| Operating expenses: | ||||||
| Cost of product sales | 3,052 | 7,544 | ||||
| Research and development | 37,976 | 36,935 | ||||
| Selling, general and administrative | 13,556 | 12,615 | ||||
| Total operating expenses | 54,584 | 57,094 | ||||
| Operating loss | (23,712) | (27,526) | ||||
| Other income (expense): | ||||||
| Investment and other income, net | 1,668 | 287 | ||||
| Interest expense | (5,230) | (5,448) | ||||
| Net loss before income taxes | (27,274) | (32,687) | ||||
| Income tax expense | 187 | 210 | ||||
| Net loss | $ | (27,461) | $ | (32,897) | ||
| Net loss per share: | ||||||
| Basic and diluted | $ | (0.19) | $ | (0.26) | ||
| Shares used in computing net loss per share: | ||||||
| Basic and diluted | 142,656 | 128,615 |
| Halozyme Therapeutics, Inc. | ||||||
| Condensed Consolidated Balance Sheets | ||||||
| (Unaudited) | ||||||
| (In thousands) | ||||||
| March 31, 2018 | December 31, 2017 | |||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 98,012 | $ | 168,740 | ||
| Marketable securities, available-for-sale | 335,682 | 300,474 | ||||
| Accounts receivable, net | 26,574 | 22,133 | ||||
| Inventories | 4,393 | 5,146 | ||||
| Prepaid expenses and other assets | 19,809 | 13,879 | ||||
| Total current assets | 484,470 | 510,372 | ||||
| Property and equipment, net | 4,937 | 3,520 | ||||
| Prepaid expenses and other assets | 5,562 | 5,553 | ||||
| Restricted cash | 500 | 500 | ||||
| Total assets | $ | 495,469 | $ | 519,945 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 3,628 | $ | 7,948 | ||
| Accrued expenses | 31,889 | 39,601 | ||||
| Deferred revenue, current portion | 1,247 | 6,568 | ||||
| Current portion of long-term debt, net | 82,460 | 77,211 | ||||
| Total current liabilities | 119,224 | 131,328 | ||||
| Deferred revenue, net of current portion | 6,006 | 54,297 | ||||
| Long-term debt, net | 102,696 | 125,140 | ||||
| Other long-term liabilities | 2,479 | 814 | ||||
| Stockholders' equity: | ||||||
| Common stock | 144 | 143 | ||||
| Additional paid-in capital | 744,359 | 731,044 | ||||
| Accumulated other comprehensive loss | (870) | (450) | ||||
| Accumulated deficit | (478,569) | (522,371) | ||||
| Total stockholders' equity | 265,064 | 208,366 | ||||
| Total liabilities and stockholders' equity | $ | 495,469 | $ | 519,945 |
Contacts: Jim Mazzola 858-704-8122 [email protected]
Chris Burton 858-704-8352 [email protected]
SOURCE Halozyme Therapeutics, Inc.