Full Press Release Details
HALOZYME REPORTS SECOND QUARTER 2016 FINANCIAL RESULTS
- Revenue guidance raised to a range of $140 million to $150 million from prior range of $130 million to $145 million -
- Strong progress in HALO-301 Phase 3 trial with site initiations in Europe, Asia Pacific and the United States -
- ENHANZE platform momentum builds with launch of HYQVIA pediatric indication, European approval of Mabthera SC in chronic lymphocytic leukemia -
SAN DIEGO, August 9, 2016 - Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results and recent highlights for the second quarter ended June 30.
"I am very pleased with the strong momentum in our ENHANZE platform leading to today's increase in our 2016 revenue guidance, driven by continued royalty revenue growth and expansion of the addressable patient population through the approval of two new indications," said Dr. Helen Torley, president and chief executive officer. "With a range of new targets being tested in phase 1 trials, ENHANZE remains a growing value driver for the company.
"We also continue to see strong, ongoing interest and support from investigators for PEGPH20 as we initiated sites in our phase 3 study in pancreatic cancer, dosed the first metastatic breast cancer patient in our clinical trial with Eisai and resumed our trial in combination with KEYTRUDA (pembrolizumab) in lung and gastric cancer patients."
Second Quarter 2016 and Recent Highlights include:
months versus 6.0 months. Safety data presented from stage 2 of the study continued to show a reduction in the rate of thromboembolic events in both treatment arms as compared to stage 1. The company expects to report mature response rate and progression free survival data from stage 2 of the study in the fourth quarter.
Second Quarter 2016 Financial Highlights
Financial Outlook for 2016
For the full year 2016, the company updated its prior guidance and now expects:
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for the second quarter 2016 today, Tuesday, August 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. 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.
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 August 9, 2016.
Halozyme Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales, net | $ | 13,699 | $ | 12,342 | $ | 26,639 | $ | 22,202 | ||||||||
| Royalties | 12,272 | 6,382 | 23,659 | 13,157 | ||||||||||||
| Revenues under collaborative agreements | 7,365 | 24,660 | 25,537 | 26,691 | ||||||||||||
| Total revenues | 33,336 | 43,384 | 75,835 | 62,050 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of product sales | 8,308 | 8,144 | 16,070 | 14,638 | ||||||||||||
| Research and development | 35,530 | 21,195 | 75,630 | 37,879 | ||||||||||||
| Selling, general and administrative | 11,221 | 9,814 | 22,027 | 19,213 | ||||||||||||
| Total operating expenses | 55,059 | 39,153 | 113,727 | 71,730 | ||||||||||||
| Operating income (loss) | (21,723 | ) | 4,231 | (37,892 | ) | (9,680 | ) | |||||||||
| Other income (expense): | ||||||||||||||||
| Investment and other income, net | 397 | 87 | 626 | 189 | ||||||||||||
| Interest expense | (5,249 | ) | (1,299 | ) | (9,125 | ) | (2,598 | ) | ||||||||
| Net (loss) income before income taxes | (26,575 | ) | 3,019 | (46,391 | ) | (12,089 | ) | |||||||||
| Income tax expense | 300 | - | 300 | - | ||||||||||||
| Net (loss) income | $ | (26,875 | ) | $ | 3,019 | $ | (46,691 | ) | $ | (12,089 | ) | |||||
| Net (loss) income per share: | ||||||||||||||||
| Basic | $ | (0.21 | ) | $ | 0.02 | $ | (0.37 | ) | $ | (0.10 | ) | |||||
| Diluted | $ | (0.21 | ) | $ | 0.02 | $ | (0.37 | ) | $ | (0.10 | ) | |||||
| Shares used in computing net (loss) income per share: | ||||||||||||||||
| Basic | 127,958 | 126,144 | 127,787 | 125,723 | ||||||||||||
| Diluted | 127,958 | 134,507 | 127,787 | 125,723 |
Halozyme Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| June 30, 2016 | December 31, 2015 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 61,233 | $ | 43,292 | ||||
| Marketable securities, available-for-sale | 168,757 | 65,047 | ||||||
| Accounts receivable, net | 23,227 | 32,410 | ||||||
| Inventories | 10,755 | 9,489 | ||||||
| Prepaid manufacturing costs | 16,740 | 16,155 | ||||||
| Prepaid expenses and other assets | 3,632 | 5,379 | ||||||
| Total current assets | 284,344 | 171,772 | ||||||
| Property and equipment, net | 4,682 | 3,943 | ||||||
| Prepaid expenses and other assets | 6,601 | 5,574 | ||||||
| Restricted cash | 500 | 500 | ||||||
| Total assets | $ | 296,127 | $ | 181,789 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,650 | $ | 4,499 | ||||
| Accrued expenses | 23,851 | 26,792 | ||||||
| Deferred revenue, current portion | 8,096 | 9,304 | ||||||
| Current portion of long-term debt | 3,288 | 21,862 | ||||||
| Total current liabilities | 38,885 | 62,457 | ||||||
| Deferred revenue, net of current portion | 41,872 | 43,919 | ||||||
| Long-term debt, net | 204,850 | 27,971 | ||||||
| Other long-term liabilities | 600 | 4,443 | ||||||
| Stockholders' equity: | ||||||||
| Common stock | 129 | 128 | ||||||
| Additional paid-in capital | 538,585 | 525,628 | ||||||
| Accumulated other comprehensive income (loss) | 216 | (99 | ) | |||||
| Accumulated deficit | (529,010 | ) | (482,658 | ) | ||||
| Total stockholders' equity | 9,920 | 42,999 | ||||||
| Total liabilities and stockholders' equity | $ | 296,127 | $ | 181,789 |