Full Press Release Details
HALOZYME REPORTS FOURTH QUARTER AND FULL-YEAR 2018 RESULTS
- ENHANZE Technology Licensed to argenx for up to Three Targets, Including Named target FcRn, Resulting in Upfront Payment of $30 Million -
- 2019 Guidance Raised for Net Revenue and Year End Cash Balance to Reflect Latest Collaboration -
- Enrollment Completed in HALO-301 with Data Projected in Second Half of 2019 -
- Finished 2018 in Strong Financial Position with $355 Million in Cash, Cash Equivalents and Marketable Securities -
SAN DIEGO, February 21, 2019 - Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today reported financial results for the fourth quarter and full year ended December 31, 2018 and provided an update on recent corporate activities.
"Our latest collaboration with argenx demonstrates the broad applicability of our ENHANZE drug delivery technology and is a great way to start the year," said Dr. Helen Torley, president and chief executive officer. "We anticipate multiple additional key milestones in our ENHANZE business including potential approval of Herceptin SC later this quarter and potential regulatory submissions for a subcutaneous formulation of Darzalex in the second half of the year. With a total of nine ENHANZE collaborations spanning from established products to new, innovative therapies addressing unmet needs, we remain confident in the potential for $1 billion in royalty revenue in 2027."
"Our PEGPH20 oncology program achieved a critical milestone during the fourth quarter with the completion of enrollment in our pivotal HALO-301 pancreas cancer study with approximately 500 patients. We also reached agreement with the FDA to change the primary endpoint for HALO-301 to a single primary endpoint of overall survival (OS), which we believe incrementally de-risked the study. We look forward with excitement to topline results from HALO-301, which we currently project in the second half of 2019."
Fourth Quarter 2018 and Recent Highlights Include:
Fourth Quarter and Full Year 2018 Financial Highlights
Revenue for the full year was $151.9 million, compared to $316.6 million in 2017.
Revenue from royalties for the full year was $79.0 million, up 24% on an as-reported basis compared to $63.5 million in 2017.
Research and development expenses for the full year were $150.3 million, compared to $150.6 million in 2017.
Selling, general and administrative expenses for 2018 were $60.8 million, compared to $53.8 million in 2017.
Net loss for the full year was $80.3 million, or $0.56 per share, compared to net income of $63.0 million in 2017, or $0.45 per share.
Financial Outlook for 2019
Halozyme updated its 2019 financial guidance, first provided on January 9, 2019, to reflect the recent argenx collaboration and license agreement:
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for the fourth quarter of 2018 today, Thursday, February 21 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 (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 387156. 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 68892505.
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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 21, 2019.
Vice President, Investor Relations and Corporate Communications
Halozyme Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
| Three Months Ended | Twelve Months Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenues: | ||||||||||||||||
| Royalties | $ | 19,338 | $ | 17,668 | $ | 78,981 | $ | 63,507 | ||||||||
| Product sales, net | 10,681 | 12,593 | 28,234 | 50,396 | ||||||||||||
| Revenues under collaborative agreements | 30,213 | 159,303 | 44,647 | 202,710 | ||||||||||||
| Total revenues | 60,232 | 189,564 | 151,862 | 316,613 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of product sales | 5,622 | 7,488 | 10,136 | 31,152 | ||||||||||||
| Research and development | 36,650 | 41,376 | 150,252 | 150,643 | ||||||||||||
| Selling, general and administrative | 18,031 | 14,771 | 60,804 | 53,816 | ||||||||||||
| Total operating expenses | 60,303 | 63,635 | 221,192 | 235,611 | ||||||||||||
| Operating (loss) income | (71 | ) | 125,929 | (69,330 | ) | 81,002 | ||||||||||
| Other income (expense): | ||||||||||||||||
| Investment and other income, net | 2,017 | 1,080 | 7,578 | 2,592 | ||||||||||||
| Interest expense | (3,755 | ) | (5,458 | ) | (18,041 | ) | (21,984 | ) | ||||||||
| Net (loss) income before income taxes | (1,809 | ) | 121,551 | (79,793 | ) | 61,610 | ||||||||||
| Income tax expense | 317 | (2,331 | ) | 537 | (1,361 | ) | ||||||||||
| Net (loss) income | $ | (2,126 | ) | $ | 123,882 | $ | (80,330 | ) | $ | 62,971 | ||||||
| Net (loss) income per share: | ||||||||||||||||
| Basic | $ | (0.01 | ) | $ | 0.87 | $ | (0.56 | ) | $ | 0.46 | ||||||
| Diluted | $ | (0.01 | ) | $ | 0.85 | $ | (0.56 | ) | $ | 0.45 | ||||||
| Shares used in computing net (loss) income per share: | ||||||||||||||||
| Basic | 144,203 | 141,718 | 143,599 | 136,419 | ||||||||||||
| Diluted | 144,203 | 145,633 | 143,599 | 139,068 |
Halozyme Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| December 31, 2018 | December 31, 2017 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 57,936 | $ | 168,740 | ||||
| Marketable securities, available-for-sale | 296,590 | 300,474 | ||||||
| Accounts receivable, net | 30,005 | 22,133 | ||||||
| Inventories | 22,625 | 5,146 | ||||||
| Prepaid expenses and other assets | 20,693 | 13,879 | ||||||
| Total current assets | 427,849 | 510,372 | ||||||
| Property and equipment, net | 7,465 | 3,520 | ||||||
| Prepaid expenses and other assets | 4,434 | 5,553 | ||||||
| Restricted cash | 500 | 500 | ||||||
| Total assets | $ | 440,248 | $ | 519,945 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,079 | $ | 7,948 | ||||
| Accrued expenses | 49,529 | 39,601 | ||||||
| Deferred revenue, current portion | 4,247 | 6,568 | ||||||
| Current portion of long-term debt, net | 91,506 | 77,211 | ||||||
| Total current liabilities | 149,361 | 131,328 | ||||||
| Deferred revenue, net of current portion | 5,008 | 54,297 | ||||||
| Long-term debt, net | 34,874 | 125,140 | ||||||
| Other long-term liabilities | 2,118 | 814 | ||||||
| Stockholders' equity: | ||||||||
| Common stock | 145 | 143 | ||||||
| Additional paid-in capital | 780,457 | 731,044 | ||||||
| Accumulated other comprehensive loss | (277 | ) | (450 | ) | ||||
| Accumulated deficit | (531,438 | ) | (522,371 | ) | ||||
| Total stockholders' equity | 248,887 | 208,366 | ||||||
| Total liabilities and stockholders' equity | $ | 440,248 | $ | 519,945 |