Attached files
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| 8-K - LIVE FILING - HALOZYME THERAPEUTICS, INC. | htm_44982.htm |
Exhibit 99.1
Media/Investor Contact:
Anne Erickson
Executive Director
Halozyme Therapeutics
858-704-8264
aerickson@halozyme.com
HALOZYME REPORTS FIRST QUARTER 2012 FINANCIAL RESULTS
SAN DIEGO, May 7, 2012 – Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the quarter ended March 31, 2012.
“We achieved a significant milestone in the first quarter with the European regulatory filing of the subcutaneous Herceptin program by our partner Roche,” said Gregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme. “Despite the HyQ regulatory delay from our Baxter collaboration, our pipeline has continued to make tangible progress on all fronts, as well as across diverse therapeutic areas and geographies.”
First Quarter Highlights
Highlights of Halozyme’s first quarter activities and recent events include:
| • | Notification from the European Patent Office (EPO) that a hearing scheduled in opposition of the European patent for Halozyme’s recombinant human hyaluronidase enzyme (rHuPH20) was cancelled and the EPO acknowledged the patentability of the claims. The Company anticipates the EPO to issue a final written decision to this effect. |
| • | Announced with our collaborator, Baxter, that the U.S. Food and Drug Administration (FDA) requested additional information to complete its review of the HyQ Biologics License Application (BLA).The Companies will work together to develop studies to provide additional data to address the concerns raised by the agency. |
| • | In addition to filing a Line Extension Application for subcutaneous (SC) Herceptin® (trastuzumab) with the European Medicines Agency (EMA), Roche presented Phase 3 registration data from the HannaH trial at the Early Breast Cancer Conference in Vienna. The study met its co-primary endpoints of pharmacokinetics and efficacy. Herceptin SC, using rHuPH20, may provide greater convenience to patients versus the traditional IV method due to its less invasive administration route and quicker administration time (5 minutes versus 30 – 90 minutes). |
| • | Roche reiterated their intent to file the Line Extension Application of subcutaneous MabThera® (rituxumab with rHuPH20) to the EMA this year for the treatment of Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia and Follicular Lymphoma. |
| • | Announced positive data with ViroPharma regarding a Phase 2 SC trial of Cinryze® (C1 esterase inhibitor [human]) in combination with rHuPH20, in patients with hereditary angioedema. Presented at the American Academy of Allergy Asthma & Immunology, the study demonstrated that SC co-administration of Cinryze with rHuPH20 was well tolerated and resulted in sustained physiologically relevant C1 INH functional concentrations. |
| • | Updated the Hylenex® recombinant (hyaluronidase human injection) label to include instructions for pre-administration of the enzyme in advance of other injected or subcutaneously infused drugs, and information from non-clinical studies that provide further data on the safety profile of Hylenex. |
First Quarter 2012 Financial Results
The net loss for the first quarter of 2012 was $15.1 million, or $0.14 per share, compared with a
net loss for the first quarter of 2011 of $9.6 million, or $0.10 per share.
| • | Revenues for the first quarter of 2012 were $7.4 million, compared to $7.5 million for the first quarter of 2011. Revenues in the first quarter of 2012 primarily consisted of a milestone payment from Roche of $4 million and research and development reimbursements from partners. |
| • | Research and development expenses for the first quarter of 2012 were $15.9 million, compared with $13.8 million for the first quarter of 2011, primarily due to an increase in manufacturing activities and compensation costs, partially offset by a decrease in clinical trial activities. |
| • | Selling, general and administrative (SG&A) expenses for the first quarter of 2012 were $6.6 million, compared to $3.4 million for the first quarter of 2011. The increase for SG&A was due to higher compensation costs and higher marketing and market research expenses during the quarter. |
| • | Cash and cash equivalents were $116.6 million as of March 31, 2012, compared with $73.8 million as of March 31, 2011. Excluding the net proceeds of $81.5 million from the financing in February 2012, net cash used in the first quarter of 2012 was approximately $17.7 million. |
Due to the HyQ regulatory delay, we anticipate 2012 cash burn to be $55-$60 million, instead of $50-$55 million as previously forecasted.
Conference Call
Halozyme will webcast its Quarterly Update Conference Call today at 4:30 p.m. ET/1:30 p.m. PT.
Gregory I. Frost, Ph.D., Halozyme’s President and Chief Executive Officer, will lead the call.
During the call, the Company plans to provide further details underlying its first quarter 2012
financial results. To access the webcast, please log on to www.halozyme.com approximately
fifteen minutes prior to the call to register, download, and install any necessary audio software.
For those without access to the Internet, the live call may be accessed by phone by calling (877)
407-8037 (domestic callers) or (201) 689-8037 (international callers). A telephone replay will be
available shortly after the call by dialing (877) 660-6853 (domestic callers) or (201) 612-7415
(international callers) using account number 367 and replay ID number 393124.
Upcoming Corporate Presentations
Halozyme is scheduled to present at the upcoming investor conference.
| • | Bank of America Merrill Lynch 2012 Healthcare Conference in Las Vegas on May 16, 2012 at 1:00 p.m. ET/10:00 a.m. PT. Gregory I. Frost, Ph.D., President and Chief Executive Officer of Halozyme Therapeutics, will provide a corporate overview. |
The presentation will be webcast through the “Investors” section of Halozyme’s corporate website at www.halozyme.com, and a recording will be made available for 90 days following the event. To access the live webcast, please log on to Halozyme’s website approximately fifteen minutes prior to the presentation to register and download any necessary audio software.
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, that increase the absorption and dispersion of biologics. Halozyme’s
pipeline addresses therapeutic areas, such as diabetes, oncology and dermatology that have
significant unmet medical need. The Company markets Hylenex® recombinant (hyaluronidase
human injection) and has partnerships with Roche, Baxter, ViroPharma 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.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking
statements including, without limitation, statements concerning the EPO’s anticipated issuance of a
final written decision regarding our European patent for rHuPH20, Roche’s anticipated filing of the
Line Extension Application of subcutaneous MabThera® (rituxumab with rHuPH20) to the
European Medicines Agency this year, our anticipated cash burn for 2012 and potential benefits and
attributes of our product candidates. These statements involve risk and uncertainties that could
cause actual results to differ materially from those in the forward-looking statements. The
forward-looking statements are also 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, clinical trial results, delays in development and
regulatory review, regulatory approval requirements and competitive conditions. These and other
factors that may result in differences are discussed in greater detail in the Company’s reports on
Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission.
Halozyme Therapeutics, Inc.
Unaudited Condensed Consolidated Statements of Operations
| Three Months Ended March 31, | ||||||||
| 2012 | 2011 | |||||||
REVENUES: |
||||||||
Product sales, net |
$ | 187,411 | $ | 165,449 | ||||
Revenues under collaborative agreements |
7,252,768 | 7,378,445 | ||||||
Total revenues |
7,440,179 | 7,543,894 | ||||||
OPERATING EXPENSES: |
||||||||
Cost of product sales |
70,761 | 11,717 | ||||||
Research and development |
15,891,109 | 13,785,797 | ||||||
Selling, general and administrative |
6,618,707 | 3,405,966 | ||||||
Total operating expenses |
22,580,577 | 17,203,480 | ||||||
OPERATING LOSS |
(15,140,398 | ) | (9,659,586 | ) | ||||
Interest and other income, net |
21,217 | 23,869 | ||||||
NET LOSS |
$ | (15,119,181 | ) | $ | (9,635,717 | ) | ||
Basic and diluted net loss per share |
$ | (0.14 | ) | $ | (0.10 | ) | ||
Shares used in computing basic and diluted net loss per share |
107,589,514 | 100,927,402 | ||||||
Halozyme Therapeutics, Inc.
Unaudited Condensed Consolidated Balance Sheets
| March 31, | December 31, | |||||||
| 2012 | 2011 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 116,608,304 | $ | 52,825,527 | ||||
Accounts receivable, net |
5,550,830 | 2,262,465 | ||||||
Inventory |
1,496,783 | 567,263 | ||||||
Prepaid expenses and other assets |
8,910,059 | 8,332,242 | ||||||
Total current assets |
132,565,976 | 63,987,497 | ||||||
Property and equipment, net |
2,152,934 | 1,771,048 | ||||||
Total Assets |
$ | 134,718,910 | $ | 65,758,545 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 3,011,181 | $ | 7,556,859 | ||||
Accrued expenses |
7,184,794 | 5,615,574 | ||||||
Deferred revenue, current portion |
6,484,800 | 4,129,407 | ||||||
Total current liabilities |
16,680,775 | 17,301,840 | ||||||
Deferred revenue, net of current portion |
36,130,767 | 36,754,583 | ||||||
Deferred rent, net of current portion |
846,957 | 802,006 | ||||||
Stockholders’ Equity: |
||||||||
Common stock |
112,411 | 103,990 | ||||||
Additional paid-in capital |
341,088,827 | 255,817,772 | ||||||
Accumulated deficit |
(260,140,827 | ) | (245,021,646 | ) | ||||
Total stockholders’ equity |
81,060,411 | 10,900,116 | ||||||
Total Liabilities and Stockholders’ Equity |
$ | 134,718,910 | $ | 65,758,545 | ||||
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