SAN DIEGO, March 8 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (AMEX: HTI) , a biopharmaceutical company developing and commercializing recombinant human enzymes, today reported financial results for the three months and year ended December 31, 2006.
"We have had a very exciting ninety days with the announcements of our recent Roche collaboration and our expanded Baxter collaboration. These are transforming events for our Company and we are working diligently to move our various programs forward," stated Jonathan Lim, MD, Halozyme's President and CEO. "We continue to make solid progress on all fronts and are meeting our milestones, including the recent completion of our INFUSE-Morphine clinical trial and our first Enhanze(TM) Technology clinical trails."
Fourth Quarter 2006 and Subsequent Weeks' Highlights
* The completion of our first Enhanze Technology collaboration with
Roche. Under the terms of the agreement, Roche paid Halozyme
$20 million as an initial upfront payment for the application of
rHuPH20 to three pre-defined Roche biologic targets. Over the next ten
years, Roche will also have the option to exclusively develop and
commercialize rHuPH20 with an additional ten targets. Pending the
successful completion of a series of clinical, regulatory and sales
events, Roche may pay Halozyme further milestones which could
potentially reach a value of up to $111 million for the first three
targets. For each of the additional ten targets, Roche may pay Halozyme
further upfront and milestone payments of up to $47 million per target,
or up to $470 million. Roche will pay Halozyme royalties on any
potential products resulting from the collaboration. In addition, the
Roche Venture Fund made an $11 million equity investment, representing
approximately 5% of Halozyme's outstanding common stock. Roche will
also obtain access to Halozyme's expertise in developing and applying
rHuPH20 to Roche targets and obtain a worldwide, exclusive license to
develop and commercialize product combinations of rHuPH20 and Roche
target compounds.
* The completion of our expanded Baxter collaboration to include the use
of HYLENEX recombinant with Baxter proprietary and non-proprietary
small molecule drugs. Under the terms of the agreements, Baxter paid
Halozyme an initial upfront payment of $10 million and made a
$20 million equity investment, representing approximately 3% of
Halozyme's outstanding common stock. Pending the successful completion
of a series of regulatory and sales events, Baxter may make further
milestone payments of up to $25 million to Halozyme. Halozyme will
also receive royalties on HYLENEX recombinant as a standalone product
and on any kits and co-formulations of HYLENEX recombinant with Baxter
or other non-proprietary small molecule drugs. Baxter prepaid
$1 million of these royalties in connection with the execution of the
agreements and will be obligated to prepay $9 million of additional
royalties on or prior to January 1, 2009. The agreements do not
include combinations of HYLENEX recombinant with cytostatic and
cytotoxic chemotherapeutic agents or bisphosphonates, the rights to
which have been retained by Halozyme. In addition, Baxter will now
assume all development, manufacturing, clinical, regulatory, sales and
marketing costs.
* The completion of our first Enhanze Technology clinical trial with a
representative commercially-available large protein molecule
therapeutic (LPMT). This clinical trial compared the
pharmacokinetics (PK), safety and tolerability of an LPMT agent
subcutaneously injected first without Enhanze Technology (rHuPH20) and
then with rHuPH20 in 15 patients. The open-label, dose escalation,
within-patient controlled study used escalating dose cohorts of rHuPH20
(ranging from 1,600 U to 12,800 U) and substituted a standard
subcutaneous (SC) injection of the LPMT with one SC injection of the
LPMT agent combined with Enhanze Technology (rHuPH20). The data from
this clinical trial support the study hypothesis that rHuPH20 increases
the relative bioavailability of the LPMT. For the primary endpoint of
area under the curve (AUC) for plasma concentration of the LPMT, the
AUC over the 14 days following injection was higher when the LPMT was
administered with rHuPH20 compared to without rHuPH20 for 100% (15/15)
of the patients in the study. The addition of rHuPH20 increased the AUC
above baseline (average trough level) of the LPMT for all cohorts
combined by an average of 58%.
* The completion of our INFUSE-Morphine clinical trial. Key results from
analysis of the 12 evaluable hospice and palliative care patients in
the trial included achieving a statistically significant acceleration
in the average time to maximal plasma concentration (Tmax) of morphine.
Tmax was reduced from 13.8 minutes when injected subcutaneously with
the saline placebo to 9.2 minutes when injected with HYLENEX
recombinant, a 33% reduction in the time to maximal plasma
concentration (p<0.05). The double-blind, randomized, crossover,
placebo-controlled, INcreased Flow Utilizing Subcutaneously-Enabled
Morphine clinical trial, or INFUSE-Morphine study, was designed to
determine the time to maximal blood levels of morphine after
subcutaneous administration with and without HYLENEX recombinant, to
determine the time to maximal blood levels after intravenous
administration of morphine, and to assess safety and tolerability.
Fourth Quarter 2006 Financial Results
* Net loss for the fourth quarter of 2006 was $4.4 million, or $0.07 per
share, compared with a net loss for the fourth quarter of 2005 of
$3.5 million, or $0.07 per share. Net loss for the full year 2006 was
$14.8 million, or $0.24 per share compared with a net loss for the full
year 2005 of $13.3 million, or $0.26 per share.
* Revenues for the fourth quarter of 2006 were $426,000, compared to
$56,000 for the fourth quarter of 2005. Cumulase product sales for the
fourth quarter of 2006 were $105,000, compared to $56,000 for the
fourth quarter of 2005.
* Research and development expenses for the fourth quarter of 2006 were
$2.7 million, compared with $2.4 million for the fourth quarter of
2005, reflecting increased clinical trial expenses associated with the
Company's HYLENEX, Enhanze Technology and Chemophase clinical trials.
* Selling, general and administrative expenses for the fourth quarter of
2006 were $2.4 million, compared with $1.2 million for the fourth
quarter of 2005, reflecting increases in legal and compensation
expenses, as well as in HYLENEX pre-launch marketing expenses over the
prior year quarter.
* Cash and cash equivalents were $44.2 million as of December 31, 2006,
compared with $19.1 as of December 31, 2005. In February 2007, the
Company received an additional $31 million in cash as a result of its
expanded collaboration with Baxter.
Conference Call
Halozyme management will host an investment community conference call today to discuss these topics beginning at 8:00 a.m. PST (11:00 a.m. EST). To participate via telephone, please call 888-463-4487 for domestic callers, or 706-679-5355 for international callers. A telephone replay will be available for 48 hours by dialing 800-642-1687 from the U.S., or 706-645-9291 for international callers, and entering reservation number 1353453. The conference call will be broadcast live over the Internet at http://www.halozyme.com/ and will be available for 30 days.
About HYLENEX
HYLENEX recombinant (hyaluronidase human injection) is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs, as an adjuvant for subcutaneous fluid administration (hypodermoclysis), and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. Hyaluronidase is contraindicated in patients with hypersensitivity to hyaluronidase enzyme or any other ingredients in the formulation. Hyaluronidase should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs. Discontinue HYLENEX recombinant if sensitization occurs. Hyaluronidase should not be applied directly to the cornea, and should not be injected around infected or acutely inflamed areas, nor used to reduce the swelling of bites or stings. Hyaluronidase should not be used for intravenous injections because the enzyme is rapidly inactivated. Furosemide, the benzodiazepines, and phenytoin are incompatible with hyaluronidase. Please see accompanying package insert for full Prescribing Information.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing recombinant human enzymes for the drug delivery, palliative care, oncology, and infertility markets. The company's portfolio of products is based on intellectual property covering the family of human enzymes known as hyaluronidases. The company's Enhanze(TM) Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Its first partnership is with Roche to apply Enhanze Technology to Roche's biological therapeutic compounds for 13 targets. In addition, the company has received FDA approval for two products: Cumulase(R) and Hylenex, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. The Company also has a number of different enzymes in its portfolio that are targeting significant areas of unmet need.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, (i) statements concerning future license or milestone payments under partnerships and collaborations, (ii) clinical trial results and the conclusions drawn from such trials and (iii) future products and/or partnerships) 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 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 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 Contact Investor Relations Contact
David A. Ramsay Don Markley
Chief Financial Officer Lippert/Heilshorn & Associates
(858) 794-8881 (310) 691-7100
dramsay@halozyme.com dmarkley@lhai.com
HALOZYME THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS - UNAUDITED
FOR THE THREE AND TWELVE MONTHS ENDED DECEMBER 31, 2006 AND 2005
Three Months Ended Twelve Months Ended
December 31 December 31
2006 2005 2006 2005
REVENUES:
Product sales $115,206 $55,863 $670,625 $127,209
Revenue under
collaborative
agreements 311,121 -- 311,121 --
Total Revenues 426,327 55,863 981,746 127,209
EXPENSES:
Cost of sales 41,399 20,853 436,990 51,968
Research and
development 2,678,749 2,411,580 9,214,759 10,220,079
Selling, general
and administrative 2,374,984 1,202,480 6,912,853 3,416,579
Total Expenses 5,095,132 3,634,913 16,564,602 13,688,626
LOSS FROM
OPERATIONS (4,668,805) (3,579,050) (15,582,856) (13,561,417)
Other income, net 290,842 65,564 830,870 286,044
NET LOSS $(4,377,963) $(3,513,486) $(14,751,986) $(13,275,373)
Net loss per
share, basic
and diluted $(0.07) $(0.07) $(0.24) $(0.26)
Shares used in
computing net
loss per share,
basic and diluted 65,402,770 51,721,370 62,610,265 50,317,021
Website: http://www.halozyme.com/