Full Press Release Details
SAN DIEGO , May 11, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO ) today reported financial results for the first quarter ended March 31, 2020 and provided an update on its recent corporate activities and outlook.
"This has been a very exciting start to the year for Halozyme as we have achieved multiple value-creating events in our ENHANZE ® business, including U.S. FDA approval for DARZALEX FASPRO TM with a broad set of label indications, and the receipt of a positive CHMP opinion in the EU, also recommending a broad set of label indications. The positive CHMP opinion is typically a precursor to marketing clearance," said Dr. Helen Torley , president and chief executive officer. "As we look ahead, we are excited about the launches of subcutaneous DARZALEX ® in the U.S. and E.U. as well as the potential FDA approval of the subcutaneous fixed-dose combination of Perjeta ® and Herceptin ® later this year, and what they may mean for patients."
"I want to express my gratitude to the Halozyme team, our partners and suppliers for our continued progress in spite of the challenges posed by COVID-19," continued Dr. Torley. "In light of these challenges, it is obviously difficult to predict how the pandemic recovery will unfold in the coming quarters. However, based on the latest information from our partners and suppliers, and our team's commitment to maintaining a lean operating structure, we feel confident maintaining our 2020 financial guidance at this time."
First Quarter 2020 and Recent Highlights Include:
First Quarter 2020 Financial Highlights
Financial Outlook for 2020
The Company continues to monitor the impact of the COVID-19 pandemic on its business and receive updates from its partners and suppliers on how their businesses are affected. Based on this information and Halozyme's planned expenditures for the year, the Company's 2020 financial guidance remains unchanged from that first provided on January 14, 2020 . For 2020 Halozyme continues to expect:
The guidance on earnings per share does not reflect any potential impact from the Company's plans to repurchase any additional number of shares, up to an additional $98 million worth, during the remainder of 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 first quarter of 2020 today, Monday, May 11, 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 (833) 968-2181 (domestic callers) or (825) 312-2108 (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 3199114.
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via three commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE ® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE ® technology 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, including any potential delays caused by the current COVID-19 global pandemic, regulatory approval requirements, unexpected adverse events or patient outcomes 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.
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, | ||||||||
| 2020 | 2019 | |||||||
| Revenues: | ||||||||
| Royalties | $ | 16,822 | $ | 17,953 | ||||
| Product sales, net | 8,147 | 8,390 | ||||||
| Revenues under collaborative agreements | 385 | 30,606 | ||||||
| Total revenues | 25,354 | 56,949 | ||||||
| Operating expenses: | ||||||||
| Cost of product sales | 5,787 | 4,649 | ||||||
| Research and development | 10,158 | 31,328 | ||||||
| Selling, general and administrative | 12,632 | 18,006 | ||||||
| Total operating expenses | 28,577 | 53,983 | ||||||
| Operating (loss) income | (3,223) | 2,966 | ||||||
| Other income (expense): | ||||||||
| Investment and other income, net | 2,479 | 2,057 | ||||||
| Interest expense | (5,348) | (3,205) | ||||||
| Net (loss) income before income taxes | (6,092) | 1,818 | ||||||
| Income tax expense | 11 | 22 | ||||||
| Net (loss) income | $ | (6,103) | $ | 1,796 | ||||
| Net (loss) income per share: | ||||||||
| Basic | $ | (0.04) | $ | 0.01 | ||||
| Diluted | $ | (0.04) | $ | 0.01 | ||||
| Shares used in computing net (loss) income per share: | ||||||||
| Basic | 137,186 | 144,743 | ||||||
| Diluted | 137,186 | 147,474 |
| Halozyme Therapeutics, Inc | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (Unaudited) | ||||||||
| (In thousands) | ||||||||
| March 31, 2020 | December 31, 2019 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 104,820 | $ | 120,179 | ||||
| Marketable securities, available-for-sale | 263,363 | 301,083 | ||||||
| Accounts receivable, net | 29,749 | 59,442 | ||||||
| Inventories | 41,452 | 29,359 | ||||||
| Prepaid expenses and other assets | 28,587 | 33,373 | ||||||
| Total current assets | 467,971 | 543,436 | ||||||
| Property and equipment, net | 11,752 | 10,855 | ||||||
| Prepaid expenses and other assets | 12,130 | 11,083 | ||||||
| Restricted cash | 500 | 500 | ||||||
| Total assets | $ | 492,353 | $ | 565,874 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 8,320 | $ | 6,434 | ||||
| Accrued expenses | 26,811 | 55,649 | ||||||
| Deferred revenue, current portion | 4,012 | 4,012 | ||||||
| Current portion of long-term debt, net | 2,859 | 19,542 | ||||||
| Total current liabilities | 42,002 | 85,637 | ||||||
| Deferred revenue, net of current portion | 641 | 1,247 | ||||||
| Long-term debt, net | 386,571 | 383,045 | ||||||
| Other long-term liabilities | 5,097 | 4,180 | ||||||
| Stockholders' equity: | ||||||||
| Common stock | 135 | 137 | ||||||
| Additional paid-in capital | 667,677 | 695,066 | ||||||
| Accumulated other comprehensive income (loss) | 11 | 240 | ||||||
| Accumulated deficit | (609,781) | (603,678) | ||||||
| Total stockholders' equity | 58,042 | 91,765 | ||||||
| Total liabilities and stockholders' equity | $ | 492,353 | $ | 565,874 |
SOURCE Halozyme Therapeutics, Inc.