Exhibit 99.1
Investor Contact:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com
Media Contact:
Nurha Hindi
Hill + Knowlton Strategies
310-633-9434
Nurha.Hindi@hkstrategies.com
HALOZYME REPORTS FOURTH QUARTER AND YEAR END 2013
FINANCIAL RESULTS
SAN DIEGO, February 27, 2014 -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the fourth quarter and full year ended December 31, 2013. Financial highlights for the fourth quarter include revenues of $12.5 million and a net loss of $22.0 million, or $0.19 per share. This compares to revenues of $21.8 million and a net loss of $4.4 million, or $0.04 per share, for the fourth quarter of 2012. Financial highlights for the full year 2013 include revenues of $54.8 million and a net loss of $83.5 million, or $0.74 per share. This compares to revenues of $42.3 million and a net loss of $53.6 million, or $0.48 per share, in the prior year.
“2013 was a year of execution, growth and transformation for Halozyme. Two of our partnered programs using the ENHANZETM platform received European approvals, we worked with Baxter on their resubmission of an amended BLA to the FDA for HyQvia® and we communicated early clinical data in pancreatic cancer from our PEGPH20 program,” stated Dr. Helen Torley, President and Chief Executive Officer. “With the proceeds from our recently completed equity offering, we begin 2014 well-positioned to advance our broad proprietary portfolio of therapeutic candidates that could potentially serve cancer, diabetes and cellulite patients.”
Fourth Quarter Highlights
• | HyQvia®: During the fourth quarter of 2013, Baxter completed submission of an amended biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) to re-initiate the review process for approval of HyQvia [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] facilitated subcutaneous infusion for the treatment of adult patients with primary immunodeficiency (PI). HyQvia is a combination of human immune globulin (IG) and recombinant human hyaluronidase. Baxter and Halozyme submitted additional preclinical data in response to the Complete Response Letter from the FDA in 2012, and expect a six-month review period. Baxter launched HyQvia into the first EU country in July 2013, and introductions in additional markets are continuing. |
Fourth Quarter and Full Year 2013 Financial Highlights
• | Revenues for the fourth quarter of 2013 were $12.5 million, compared to $21.8 million for the fourth quarter of 2012. Revenues in the fourth quarter of 2013 included $5.8 million in product sales of bulk rHuPH20 for use in partnered product manufacturing, $4.0 million in Hylenex® product sales, including a one-time adjustment of $1.1 million, and $2.7 million in collaboration revenues. Revenues in the fourth quarter of 2012 included one-time, upfront payments of $9.5 million from Pfizer. Revenues for the full year 2013 were $54.8 million compared to $42.3 million for 2012. |
• | Research and development expenses for the fourth quarter of 2013 were $20.9 million, compared with $18.6 million for the fourth quarter of 2012. The increase is primarily due to increased clinical trial activities, offset in part by a decrease in manufacturing costs. |
• | Selling, general and administrative expenses for the fourth quarter of 2013 were $9.4 million, compared to $7.0 million for the fourth quarter of 2012. The increase was mainly due to an increase in commercial activities. |
• | The net loss for the fourth quarter of 2013 was $22.0 million, or $0.19 per share, compared with a net loss for the fourth quarter of 2012 of $4.4 million, or $0.04 per share. The net loss for the 12 months ended December 31, 2013 was $83.5 million, or $0.74 per share, compared to a net loss of $53.6 million, or $0.48 per share for the full year 2012. |
• | Cash, cash equivalents and marketable securities were $71.5 million at December 31, 2013, compared with $65.3 million at September 30, 2013 and $99.5 million at December 31, 2012. Cash, cash equivalents and marketable securities at December 31, 2013 included net proceeds of $19 million from the additional term loan with Oxford Finance and Silicon Valley Bank for working capital and other near-term growth initiatives. Excluding the proceeds from the term loan, net cash used in the fourth quarter of 2013 was approximately $12.8 million. In February 2014, the Company raised approximately $107.8 million through an underwritten public offering of 8.8 million shares of its common stock. |
Financial Outlook for 2014
• | For 2014, excluding the proceeds from the recent financing, the company expects net cash burn to be between $45 and $55 million for the year. |
Webcast and Conference Call
Halozyme will webcast its quarterly update conference call today, February 27, 2014 at 4:30 p.m. EST/1:30 p.m. PST. During the call, management will discuss the financial results for the fourth quarter of 2013 and provide a business update. To listen to the live webcast please visit the "Investors" section of Halozyme's corporate website at www.halozyme.com. A webcast replay will be available shortly after the call at the same address. To participate by phone, please dial (877) 407-8037 (domestic callers) or (201) 689-8037 (international callers). A telephone replay will be available by dialing (877) 660-6853 (domestic callers) or (201) 612-7415 (international callers) using replay ID number 13576874.
About Halozyme
Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company's research focuses primarily on a family of human enzymes, known as hyaluronidases, which increase the dispersion and absorption of biologics, drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer, Baxter, and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com and follow us on Twitter @HALOTherapeutic.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the expected timing of the FDA’s response to the HyQvia® amended BLA submission, the Company's future expectations and plans for the development and commercialization of product candidates and the potential benefits and attributes of such product candidates and expected cash burn for 2014) 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 from collaborators, unexpected results or delays in development 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 8, 2013.
Halozyme Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
Three Months Ended | Twelve Months Ended | ||||||||||||||
December 31, | December 31, | ||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||
REVENUES: | |||||||||||||||
Product sales, net | $ | 9,806,378 | $ | 1,459,735 | $ | 24,439,724 | $ | 2,887,442 | |||||||
Revenues under collaborative agreements | 2,692,555 | 20,333,814 | 30,359,723 | 39,437,784 | |||||||||||
Total revenues | 12,498,933 | 21,793,549 | 54,799,447 | 42,325,226 | |||||||||||
OPERATING EXPENSES: | |||||||||||||||
Cost of product sales | 3,540,128 | 653,884 | 6,245,761 | 1,094,400 | |||||||||||
Research and development | 20,925,194 | 18,567,744 | 96,639,575 | 70,044,073 | |||||||||||
Selling, general and administrative | 9,356,971 | 6,979,034 | 32,347,748 | 24,812,199 | |||||||||||
Total operating expenses | 33,822,293 | 26,200,662 | 135,233,084 | 95,950,672 | |||||||||||
OPERATING LOSS | (21,323,360 | ) | (4,407,113 | ) | (80,433,637 | ) | (53,625,446 | ) | |||||||
Investment and other income | 64,685 | 1,257 | 229,229 | 73,444 | |||||||||||
Interest expense | (727,628 | ) | — | (3,274,143 | ) | — | |||||||||
NET LOSS | $ | (21,986,303 | ) | $ | (4,405,856 | ) | $ | (83,478,551 | ) | $ | (53,552,002 | ) | |||
Basic and diluted net loss per share | $ | (0.19 | ) | $ | (0.04 | ) | $ | (0.74 | ) | $ | (0.48 | ) | |||
Shares used in computing basic and diluted net loss per share | 113,550,229 | 112,323,056 | 112,805,439 | 111,077,105 |
Halozyme Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
December 31, 2013 | December 31, 2012 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 27,356,947 | $ | 99,501,264 | |||
Marketable securities, available-for-sale | 44,145,697 | — | |||||
Accounts receivable, net | 9,097,084 | 15,703,087 | |||||
Inventories | 6,169,982 | 2,670,696 | |||||
Prepaid expenses and other assets | 8,425,684 | 12,752,888 | |||||
Total current assets | 95,195,394 | 130,627,935 | |||||
Property and equipment, net | 3,421,506 | 3,700,462 | |||||
Prepaid expenses and other assets | 2,675,692 | — | |||||
Restricted cash | 500,000 | 400,000 | |||||
Total Assets | $ | 101,792,592 | $ | 134,728,397 | |||
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,134,757 | $ | 2,271,689 | |||
Accrued expenses | 14,920,446 | 7,783,447 | |||||
Deferred revenue, current portion | 7,397,829 | 8,891,017 | |||||
Total current liabilities | 25,453,032 | 18,946,153 | |||||
Deferred revenue, net of current portion | 45,745,449 | 34,954,966 | |||||
Long-term debt, net | 49,771,737 | 29,661,680 | |||||
Lease financing obligation | — | 1,450,000 | |||||
Deferred rent, net of current portion | 794,782 | 861,879 | |||||
Other long-term liability | 18,268 | — | |||||
Stockholders’ (deficit) equity: | |||||||
Common stock | 114,534 | 112,709 | |||||
Additional paid-in capital | 361,929,935 | 347,314,658 | |||||
Accumulated other comprehensive income | 17,054 | — | |||||
Accumulated deficit | (382,052,199 | ) | (298,573,648 | ) | |||
Total stockholders’ (deficit) equity | (19,990,676 | ) | 48,853,719 | ||||
Total Liabilities and Stockholders’ (Deficit) Equity | $ | 101,792,592 | $ | 134,728,397 |
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