Full Press Release Details
HALOZYME REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS
- ENHANZE Licensed to Roche for up to Three Additional Targets, Includes $25 Million Upfront Payment, Plus the Potential for Future Milestone and Royalty Payments -
- 2018 Guidance Raised for Net Revenue and Year End Cash Balance, and Reduced for Operating Expenses and Cash Burn -
- Revenue of $25.6 Million Includes a 9% Increase in Royalty Revenue on a Reported Basis -
- Management to Host Webcast/Conference Call Today at 4:30 p.m. ET/1:30 p.m. PT -
SAN DIEGO, November 6, 2018 - Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today reported financial results for the third quarter ended September 30, 2018 and provided an update on recent corporate activities.
"The expanded agreement we have signed with Roche, covering up to three new targets, speaks to the compelling and ongoing value proposition of our ENHANZE technology," said Dr. Helen Torley, president and chief executive officer. "The overall progress we made recently with the initiation of two Phase 1 trials combining ENHANZE with Alexion's ALXN1210 and Bristol-Myers Squibb's BMS-986179, an investigational anti-CD-73 antibody, reinforces our confidence in the potential for $1 billion in royalty revenue in 2027 and for up to $1 billion in cumulative lifetime milestone payments associated with our partners' programs."
"Turning to our second potential growth engine, PEGPH20, we continue to make good progress with our pivotal HALO-301 pancreas cancer study and in our exploration of the pan tumor potential of PEGPH20. We are pleased to have moved into the randomization phase of our study in patients with cholangiocarcinoma and gall bladder cancer in August. Interest is high, with enrollment progressing very well in the randomization phase to date."
Third Quarter 2018 and Recent Highlights Include:
achievement of specified development, regulatory and sales-based milestones. Halozyme will also receive mid-single digit royalties on sales of commercialized products.
Third Quarter 2018 Financial Highlights
Financial Outlook for 2018
For the full year 2018, the company is updating its prior guidance ranges for net revenue, operating expenses, operating cash burn and year-end cash, and is now expecting:
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for the third quarter of 2018 today, Tuesday, November 6 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 55575898.
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 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 future growth, revenue and milestone payments, 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 November 6, 2018.
Westwicke Partners, LLC
Halozyme Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenues: | ||||||||||||||||
| Royalties | $ | 18,710 | $ | 17,119 | $ | 59,643 | $ | 45,839 | ||||||||
| Product sales, net | 6,269 | 13,589 | 17,553 | 37,803 | ||||||||||||
| Revenues under collaborative agreements | 577 | 33,023 | 14,434 | 43,407 | ||||||||||||
| Total revenues | 25,556 | 63,731 | 91,630 | 127,049 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of product sales | 626 | 8,332 | 4,514 | 23,664 | ||||||||||||
| Research and development | 35,540 | 33,993 | 113,602 | 109,267 | ||||||||||||
| Selling, general and administrative | 14,864 | 13,329 | 42,773 | 39,045 | ||||||||||||
| Total operating expenses | 51,030 | 55,654 | 160,889 | 171,976 | ||||||||||||
| Operating (loss) income | (25,474 | ) | 8,077 | (69,259 | ) | (44,927 | ) | |||||||||
| Other income (expense): | ||||||||||||||||
| Investment and other income, net | 1,910 | 790 | 5,561 | 1,512 | ||||||||||||
| Interest expense | (4,286 | ) | (5,538 | ) | (14,286 | ) | (16,526 | ) | ||||||||
| Net (loss) income before income taxes | (27,850 | ) | 3,329 | (77,984 | ) | (59,941 | ) | |||||||||
| Income tax expense | - | 580 | 220 | 970 | ||||||||||||
| Net (loss) income | $ | (27,850 | ) | $ | 2,749 | $ | (78,204 | ) | $ | (60,911 | ) | |||||
| Net (loss) income per share: | ||||||||||||||||
| Basic | $ | (0.19 | ) | $ | 0.02 | $ | (0.55 | ) | $ | (0.45 | ) | |||||
| Diluted | $ | (0.19 | ) | $ | 0.02 | $ | (0.55 | ) | $ | (0.45 | ) | |||||
| Shares used in computing net (loss) income per share: | ||||||||||||||||
| Basic | 143,949 | 141,190 | 143,396 | 134,633 | ||||||||||||
| Diluted | 143,949 | 143,236 | 143,396 | 134,633 |
Halozyme Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| September 30, 2018 | December 31, 2017 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 55,019 | $ | 168,740 | ||||
| Marketable securities, available-for-sale | 309,347 | 300,474 | ||||||
| Accounts receivable, net and other contract assets | 27,656 | 22,133 | ||||||
| Inventories | 18,285 | 5,146 | ||||||
| Prepaid expenses and other assets | 19,619 | 13,879 | ||||||
| Total current assets | 429,926 | 510,372 | ||||||
| Property and equipment, net | 6,790 | 3,520 | ||||||
| Prepaid expenses and other assets | 7,291 | 5,553 | ||||||
| Restricted cash | 500 | 500 | ||||||
| Total assets | $ | 444,507 | $ | 519,945 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,331 | $ | 7,948 | ||||
| Accrued expenses | 43,020 | 39,601 | ||||||
| Deferred revenue, current portion | 4,247 | 6,568 | ||||||
| Current portion of long-term debt, net | 88,521 | 77,211 | ||||||
| Total current liabilities | 139,119 | 131,328 | ||||||
| Deferred revenue, net of current portion | 5,507 | 54,297 | ||||||
| Long-term debt, net | 57,940 | 125,140 | ||||||
| Other long-term liabilities | 2,203 | 814 | ||||||
| Stockholders' equity: | ||||||||
| Common stock | 145 | 143 | ||||||
| Additional paid-in capital | 769,382 | 731,044 | ||||||
| Accumulated other comprehensive loss | (478 | ) | (450 | ) | ||||
| Accumulated deficit | (529,311 | ) | (522,371 | ) | ||||
| Total stockholders' equity | 239,738 | 208,366 | ||||||
| Total liabilities and stockholders' equity | $ | 444,507 | $ | 519,945 |