Full Press Release Details
HALOZYME REPORTS FOURTH QUARTER AND FULL YEAR 2019 RESULTS
- Halozyme Reiterates 2020 Guidance of $230 to $245 Million in Revenues and $0.60 to $0.75 Earnings Per Share with Profitability Beginning in Second Quarter -
-Two ENHANZE Partnered Drugs Now Under US and EU Regulatory Review with Potential US Launches in 2020 -
- $200 Million of Shares Repurchased Under $550 Million Board Authorization with plans to Repurchase up to An Additional $150 Million in 2020 -
SAN DIEGO, February 24, 2020 - Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the fourth quarter and full year ended December 31, 2019 and provided an update on its recent corporate activities and outlook.
"I am pleased to report 2020 is off to a strong start as we have substantially completed our actions to reposition the company to focus on ENHANZE ," said Dr. Helen Torley, president and chief executive officer. "As a result of our decisive actions, we expect to become sustainably profitable in the second quarter. In addition, we anticipate multiple events that will grow the value of our ENHANZE technology in 2020. Both the subcutaneous formulation of Darzalex and the fixed-dose combination of Perjeta -Herceptin are under regulatory review in the U.S. and EU with potential approvals and launches expected this year. We anticipate three ENHANZE pipeline candidates to begin Phase 3 testing, one to begin Phase 2, and at least five new Phase 1 trial starts. With these key developments, a transition to profitability and plans for continued return of capital, Halozyme has never been in a stronger position to deliver value for our shareholders. With a target of 19 products in clinical development or already commercialized by the end of this year, we continue to see the potential for our royalty revenues to achieve $1 billion by 2027."
Fourth Quarter 2019 and Recent Highlights Include:
Fourth Quarter and Full Year 2019 Financial Highlights
Total revenues for the full year were $196.0 million, compared with $151.9 million in 2018, representing growth of 29% year over year.
Research and development expenses for the full year were $140.8 million, compared with $150.3 million in 2018.
Selling, general and administrative expenses for the full year were $77.3 million, compared with $60.8 million in 2018.
Net loss for the full year was $72.2 million or $0.50 per share, compared to $80.3 million or $0.56 per share in 2018.
Financial Outlook for 2020
Halozyme is reiterating its 2020 financial guidance ranges as first announced on January 14, 2020. For 2020 Halozyme expects:
The guidance earnings per share does not reflect any potential impact from the Company's plans to repurchase an additional number of shares, up to $150 million worth, during 2020. The amount and timing of shares repurchased during 2020 will be subject to a variety of factors including market conditions, other business considerations and applicable legal requirements.
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for the fourth quarter of 2019 today, Monday, February 24, 2020 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) 824-0907 (domestic callers) or (647) 689-5655 (international callers). A telephone replay will be available after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 1266162.
Halozyme Therapeutics is a biotechnology company focused on novel biological and drug delivery approaches. Halozyme's proprietary enzyme rHuPH20 is used to facilitate the delivery of injected drugs and fluids and potentially reduce the treatment burden of other drugs to patients. Halozyme has licensed its rHuPH20 technology, called ENHANZE , to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE . 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 in this press release include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance (including the Company's financial outlook for 2020) and expectations for
profitability, revenue, expenses and earnings-per-share and the Company's plans to continue its share repurchase program. Forward-looking statements regarding the Company's ENHANZE drug delivery technology may include the possible activity, benefits and attributes of ENHANZE , the possible method of action of ENHANZE , its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery of injectable medications through subcutaneous delivery. Forward-looking statements regarding the Company's ENHANZE business may include potential growth driven by our partners' development and commercialization efforts, potential new ENHANZE collaborations and collaborative targets and regulatory review and potential approvals of new ENHANZE products. These 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 and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected delays in the execution of the Company's share repurchase program, unexpected results or delays in the growth of the Company's ENHANZE business, or in the development, regulatory review or commercialization of ENHANZE products, 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 most recently filed Annual Report on Form 10-K filed with the Securities and Exchange Commission.
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 | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Revenues: | ||||||||||||||||
| Royalties | $ | 17,230 | $ | 19,338 | $ | 69,899 | $ | 78,981 | ||||||||
| Product sales, net | 22,693 | 10,681 | 66,048 | 28,234 | ||||||||||||
| Revenues under collaborative agreements | 13,742 | 30,213 | 60,045 | 44,647 | ||||||||||||
| Total revenues | 53,665 | 60,232 | 195,992 | 151,862 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of product sales | 16,687 | 5,622 | 45,546 | 10,136 | ||||||||||||
| Research and development | 45,111 | 36,650 | 140,804 | 150,252 | ||||||||||||
| Selling, general and administrative | 23,929 | 18,031 | 77,252 | 60,804 | ||||||||||||
| Total operating expenses | 85,727 | 60,303 | 263,602 | 221,192 | ||||||||||||
| Operating loss | (32,062 | ) | (71 | ) | (67,610 | ) | (69,330 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Investment and other income, net | 1,333 | 2,017 | 6,986 | 7,578 | ||||||||||||
| Interest expense | (3,731 | ) | (3,755 | ) | (11,627 | ) | (18,041 | ) | ||||||||
| Net loss before income taxes | (34,460 | ) | (1,809 | ) | (72,251 | ) | (79,793 | ) | ||||||||
| Income tax expense | (63 | ) | 317 | (11 | ) | 537 | ||||||||||
| Net loss | $ | (34,397 | ) | $ | (2,126 | ) | $ | (72,240 | ) | $ | (80,330 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic | $ | (0.24 | ) | $ | (0.01 | ) | $ | (0.50 | ) | $ | (0.56 | ) | ||||
| Diluted | $ | (0.24 | ) | $ | (0.01 | ) | $ | (0.50 | ) | $ | (0.56 | ) | ||||
| Shares used in computing net loss per share: | ||||||||||||||||
| Basic | 141,046 | 144,203 | 144,329 | 143,599 | ||||||||||||
| Diluted | 141,046 | 144,203 | 144,329 | 143,599 |
Halozyme Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| December 31, 2019 | December 31, 2018 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 120,179 | $ | 57,936 | ||||
| Marketable securities, available-for-sale | 301,083 | 296,590 | ||||||
| Accounts receivable, net | 59,442 | 30,005 | ||||||
| Inventories | 29,359 | 22,625 | ||||||
| Prepaid expenses and other assets | 33,373 | 20,693 | ||||||
| Total current assets | 543,436 | 427,849 | ||||||
| Property and equipment, net | 10,855 | 7,465 | ||||||
| Prepaid expenses and other assets | 11,083 | 4,434 | ||||||
| Restricted cash | 500 | 500 | ||||||
| Total assets | $ | 565,874 | $ | 440,248 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,434 | $ | 4,079 | ||||
| Accrued expenses | 55,649 | 49,529 | ||||||
| Deferred revenue, current portion | 4,012 | 4,247 | ||||||
| Current portion of long-term debt, net | 19,542 | 91,506 | ||||||
| Total current liabilities | 85,637 | 149,361 | ||||||
| Deferred revenue, net of current portion | 1,247 | 5,008 | ||||||
| Long-term debt, net | 383,045 | 34,874 | ||||||
| Other long-term liabilities | 4,180 | 2,118 | ||||||
| Stockholders' equity: | ||||||||
| Common stock | 137 | 145 | ||||||
| Additional paid-in capital | 695,066 | 780,457 | ||||||
| Accumulated other comprehensive income (loss) | 240 | (277 | ) | |||||
| Accumulated deficit | (603,678 | ) | (531,438 | ) | ||||
| Total stockholders' equity | 91,765 | 248,887 | ||||||
| Total liabilities and stockholders' equity | $ | 565,874 | $ | 440,248 |