Full Press Release Details
SAN DIEGO , May 7, 2019 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO ), a biotechnology company developing novel oncology and drug-delivery therapies, today reported financial results for the first quarter ended March 31, 2019 and provided an update on recent corporate activities.
"We enjoyed a strong start to 2019 as our first quarter included a new ENHANZE ® collaboration with argenx, positive phase III data from Janssen's COLUMBA study evaluating a subcutaneous formulation of DARZALEX ® , and FDA approval of Herceptin Hylecta™," said Dr. Helen Torley , president and chief executive officer. "Looking ahead in 2019, we expect this momentum to continue. On ENHANZE ® we anticipate regulatory submissions by ENHANZE ® partner Janssen for the subcutaneous formulation of DARZALEX ® , a new phase 3 trial initiation by one of our ENHANZE ® partners and multiple Phase 1 trial initiations. On PEGPH20, we project the announcement of topline results from our HALO-301 pivotal phase 3 trial in pancreas cancer in the second half of the year."
First Quarter 2019 and Recent Highlights Include:
First Quarter 2019 Financial Highlights
Financial Outlook for 2019
Halozyme reiterates its overall 2019 financial guidance while lowering the anticipated contribution from royalties and increasing the anticipated contribution from products sales related to API. For 2019, Halozyme now expects:
This guidance continues to exclude revenue from any potential, new ENHANZE ® global collaboration and licensing agreements.
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for the first quarter of 2019 today, Tuesday, May 7, 2019 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 replay will be 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 (866) 393-4306 (domestic callers) or (734) 385-2616 (international callers). A telephone replay will be available after the call by dialing (855) 859-2056 (domestic callers) or (404) 537-3406 (international callers) using replay ID number 3076769.
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 the treatment of several cancers and has the potential to be used 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, Alexion and argenx 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 future growth, revenue and milestone and other potential payments from collaboration partners, 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 2019) 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 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 7, 2019 .
Contact: Al Kildani Vice President, Investor Relations and Corporate Communications 858-704-8122 [email protected]
| Halozyme Therapeutics, Inc. Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except per share amounts) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2019 | 2018 | |||||||
| Revenues: | ||||||||
| Royalties | $ | 17,953 | $ | 20,944 | ||||
| Product sales, net | 8,390 | 6,801 | ||||||
| Revenues under collaborative agreements | 30,606 | 3,127 | ||||||
| Total revenues | 56,949 | 30,872 | ||||||
| Operating expenses: | ||||||||
| Cost of product sales | 4,649 | 3,052 | ||||||
| Research and development | 31,328 | 37,976 | ||||||
| Selling, general and administrative | 18,006 | 13,556 | ||||||
| Total operating expenses | 53,983 | 54,584 | ||||||
| Operating income (loss) | 2,966 | (23,712) | ||||||
| Other income (expense): | ||||||||
| Investment and other income, net | 2,057 | 1,668 | ||||||
| Interest expense | (3,205) | (5,230) | ||||||
| Net income (loss) before income taxes | 1,818 | (27,274) | ||||||
| Income tax expense | 22 | 187 | ||||||
| Net income (loss) | $ | 1,796 | $ | (27,461) | ||||
| Net income (loss) per share: | ||||||||
| Basic | $ | 0.01 | $ | (0.19) | ||||
| Diluted | $ | 0.01 | $ | (0.19) | ||||
| Shares used in computing net income (loss) per share: | ||||||||
| Basic | 144,743 | 142,656 | ||||||
| Diluted | 147,474 | 142,656 |
| Halozyme Therapeutics, Inc. Condensed Consolidated Balance Sheets (Unaudited) (In thousands) | ||||||||
| March 31, 2019 | December 31, 2018 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 60,595 | $ | 57,936 | ||||
| Marketable securities, available-for-sale | 268,122 | 296,590 | ||||||
| Accounts receivable, net | 28,164 | 30,005 | ||||||
| Inventories | 31,241 | 22,625 | ||||||
| Prepaid expenses and other assets | 20,914 | 20,693 | ||||||
| Total current assets | 409,036 | 427,849 | ||||||
| Property and equipment, net | 14,542 | 7,465 | ||||||
| Prepaid expenses and other assets | 5,031 | 4,434 | ||||||
| Restricted cash | 500 | 500 | ||||||
| Total assets | $ | 429,109 | $ | 440,248 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,089 | $ | 4,079 | ||||
| Accrued expenses | 43,663 | 49,529 | ||||||
| Deferred revenue, current portion | 4,247 | 4,247 | ||||||
| Current portion of long-term debt, net | 86,663 | 91,506 | ||||||
| Total current liabilities | 138,662 | 149,361 | ||||||
| Deferred revenue, net of current portion | 4,509 | 5,008 | ||||||
| Long-term debt, net | 18,742 | 34,874 | ||||||
| Other long-term liabilities | 7,149 | 2,118 | ||||||
| Stockholders' equity: | ||||||||
| Common stock | 145 | 145 | ||||||
| Additional paid-in capital | 789,483 | 780,457 | ||||||
| Accumulated other comprehensive income (loss) | 61 | (277) | ||||||
| Accumulated deficit | (529,642) | (531,438) | ||||||
| Total stockholders' equity | 260,047 | 248,887 | ||||||
| Total liabilities and stockholders' equity | $ | 429,109 | $ | 440,248 |
SOURCE Halozyme Therapeutics, Inc.