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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Halozyme Therapeutics Incorporated | NASDAQ:HALO | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.43 | -0.94% | 45.39 | 45.00 | 45.60 | 46.1599 | 45.22 | 45.86 | 1,037,269 | 23:23:37 |
SAN DIEGO, Nov. 10, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the third quarter ended September 30, 2014. Financial highlights for the third quarter include revenues of $14.6 million and a net loss of $20.3 million, or $0.16 per share. This compares to revenues of $16.0 million and a net loss of $19.3 million, or $0.17 per share, for the third quarter of 2013.
"The third quarter was notable for completion of a review and update to our corporate strategy based on a portfolio assessment. The recent Fast Track and Orphan Drug designations for PEGPH20, new pre-clinical data further supporting the pan-tumor potential for PEGPH20 and strong investigator interest in both pancreatic and lung cancer trials have confirmed this as our priority proprietary product for investment. The growth in the number of approvals for ENHANZE™ – based products and the launch success of Roche's Herceptin SC affirms our confidence in the growth potential of the ENHANZE platform," stated Dr. Helen Torley, President and Chief Executive Officer. "Our pursuit of Hylenex® in Type 1 diabetes is a potential opportunity to expand the indication and increase sales of Hylenex. While discussions with the FDA are ongoing, we have learned that the FDA will likely request additional clinical data for a label update translating to potentially higher projected costs and longer time to market than had originally been anticipated. In the ongoing weeks, we intend to continue to seek clarity with FDA on what data will be required, if any. Once we have gained clarity as to the regulatory requirements for a label update, we intend to enter into collaborations with third parties or explore other strategic alternatives in order to exploit this opportunity. I am excited by the opportunity to focus our resources on advancing PEGPH20 and to expand utilization of our ENHANZE platform."
Third Quarter 2014 Highlights
Third Quarter and Nine Months 2014 Financial Highlights
Webcast and Conference Call
Halozyme will webcast its quarterly update conference call today, November 10, 2014 at 4:30 p.m. EDT/1:30 p.m. PDT. During the call, management will discuss the financial results for the third quarter of 2014 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 (866) 710-0179 (domestic callers) or (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available shortly after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 45298549.
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 oncology, diabetes and dermatology that have significant unmet medical need today. The company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer and Baxter. Halozyme is headquartered in San Diego. For more information on how we are innovating, please visit our corporate website at 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 enrollment of patients in Study 202 for PEGPH20, the development and commercialization of product candidates including planned clinical trials, the potential benefits and attributes of such product candidates, gaining clarity as to the regulatory pathway for updating the Hylenex® label for use in Type 1 diabetes, entering into new collaborations and potential royalty revenue from products from collaborations) 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 10, 2014.
Halozyme Therapeutics, Inc | |||||||||
Condensed Consolidated Statements of Operations | |||||||||
(Unaudited) | |||||||||
(in thousands, except per share data) | |||||||||
Three Months Ended |
Nine Months Ended | ||||||||
2014 |
2013 |
2014 |
2013 | ||||||
Revenues: |
|||||||||
Product sales, net |
$ 9,617 |
$ 10,025 |
$ 27,679 |
$ 14,634 | |||||
Royalties |
2,895 |
- |
5,382 |
- | |||||
Revenues under collaborative agreements |
2,094 |
5,988 |
11,896 |
27,667 | |||||
Total revenues |
14,606 |
16,013 |
44,957 |
42,301 | |||||
Operating Expenses: |
|||||||||
Cost of product sales |
5,141 |
683 |
16,585 |
2,706 | |||||
Research and development |
19,904 |
25,689 |
59,968 |
75,714 | |||||
Selling, general and administrative |
8,587 |
8,135 |
27,589 |
22,991 | |||||
Total operating expenses |
33,632 |
34,507 |
104,142 |
101,411 | |||||
Operating loss |
(19,026) |
(18,494) |
(59,185) |
(59,110) | |||||
Investment and other income, net |
122 |
52 |
287 |
165 | |||||
Interest expense |
(1,376) |
(850) |
(4,203) |
(2,547) | |||||
Net Loss |
$ (20,280) |
$ (19,292) |
$ (63,101) |
$ (61,492) | |||||
Basic and diluted net loss per share |
$ (0.16) |
$ (0.17) |
$ (0.52) |
$ (0.55) | |||||
Shares used in computing basic and diluted net loss per share |
124,041 |
112,765 |
122,157 |
112,554 |
Halozyme Therapeutics, Inc | |||||
Condensed Consolidated Balance Sheets | |||||
(Unaudited) | |||||
(in thousands) | |||||
September 30, |
December 31, | ||||
2014 |
2013 | ||||
ASSETS |
|||||
Current assets: |
|||||
Cash and cash equivalents |
$ 46,375 |
$ 27,357 | |||
Marketable securities, available-for-sale |
88,089 |
44,146 | |||
Accounts receivable, net |
8,275 |
9,097 | |||
Inventories |
6,916 |
6,170 | |||
Prepaid expenses and other assets |
8,945 |
8,425 | |||
Total current assets |
158,600 |
95,195 | |||
Property and equipment, net |
3,249 |
3,422 | |||
Prepaid expenses and other assets |
2,277 |
2,676 | |||
Restricted cash |
500 |
500 | |||
Total Assets |
$ 164,626 |
$ 101,793 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) |
|||||
Current liabilities: |
|||||
Accounts payable |
$ 4,342 |
$ 3,135 | |||
Accrued expenses |
15,023 |
14,369 | |||
Deferred revenue, current portion |
5,153 |
7,398 | |||
Current portion of long-term debt, net |
10,075 |
- | |||
Total current liabilities |
34,593 |
24,902 | |||
Deferred revenue, net of current portion |
47,572 |
45,745 | |||
Long-term debt, net |
39,762 |
49,772 | |||
Other long-term liabilities |
2,759 |
1,364 | |||
Stockholders' equity (deficit): |
|||||
Common stock |
125 |
115 | |||
Additional paid-in capital |
485,014 |
361,930 | |||
Accumulated other comprehensive (loss) income |
(46) |
17 | |||
Accumulated deficit |
(445,153) |
(382,052) | |||
Total stockholders' equity (deficit) |
39,940 |
(19,990) | |||
Total Liabilities and Stockholders' Equity (Deficit) |
$ 164,626 |
$ 101,793 | |||
Investor Contact:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com
Media Contact:
Susan Neath Francis
212-301-7182
sfrancis@w2ogroup.com
Logo - http://photos.prnewswire.com/prnh/20100302/LA63139LOGO
SOURCE Halozyme Therapeutics, Inc.
Copyright 2014 PR Newswire
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