SAN DIEGO, Nov. 6 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the drug delivery, endocrinology, oncology, and dermatology markets, today reported financial results for the three and nine months ended September 30, 2008.
"The fundamentals for Halozyme have never been stronger and I am pleased with the initiation of our Phase 2 insulin clinical trial. The study will test our proprietary rHuPH20 hyaluronidase enzyme with two commercially available insulins in diabetic patients," stated Jonathan Lim, M.D., President and CEO of Halozyme. "Other Halozyme clinical programs are also moving forward expeditiously and Phase 1 studies in our bisphosphonate and PEGPH20 programs should be starting soon. Our five proprietary programs focus on the development of first-in-class or best-in-class compounds that target large commercial markets and the initiation of additional human clinical studies should enhance the value of our pipeline and drive shareholder returns."
Recent Corporate and Scientific Achievements
-- A Phase 2 insulin clinical trial has been initiated in Type 1 diabetic patients that will compare glycemic control of a standardized liquid meal challenge and insulin pharmacokinetics after administration of each of four dosing regimens: Humulin(R) R (regular insulin human) with and without rHuPH20 and Humalog(R) (insulin lispro) with and without rHuPH20. The study is designed to detect faster absorption and a more rapid onset of action for both types of insulin when given in combination with Halozyme's rHuPH20 enzyme. Results should be available in mid-2009.
-- A clinical study in bladder cancer patients has been initiated that will test immediate post operative (IPOP) intravesical administration of Chemophase, the combination of rHuPH20 with mitomycin C immediately following transurethral resection of bladder tumor (TURBT). Results of this small safety study will be used to support the inclusion of the IPOP dosing regimen as part of the protocol in future Chemophase studies. Halozyme is making preparations to meet with regulatory authorities during the first half of 2009 to discuss the trial design for potential registration studies.
-- Halozyme hosted its first Research Day for financial analysts and the investment community on October 6, 2008 in New York. The well attended event provided a forum for an in depth presentation and discussion by the Halozyme management team of its proprietary product development pipeline, its plans for future clinical trials, and its business strategy. A replay of the meeting can be found on the Halozyme website. (http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-calendar)
-- The company has recently strengthened its senior management team with the addition of Douglas B. Muchmore, M.D., Vice President, Endocrinology Clinical Development, Patrick O'Connor, Ph.D., Vice President, Research, Michael J. LaBarre, Ph.D., Vice President, Product Development, and James E. Cartoni, Vice President, Legal. Successfully recruiting, developing, and retaining high caliber, experienced executives exemplifies Halozyme's commitment to exceptional talent.
-- Positive pre-clinical animal efficacy data (http://www.halozyme.com/2008AACRTCsk-4%20-%20large.pdf)were presented for PEGPH20 at the American Association for Cancer Research (AACR) Translational Cancer Medicine meeting in Monterey, Calif. on July 21, 2008. The study demonstrated in mouse models that treatment of hormone resistant human prostate cancer with intravenous PEGPH20 in combination with the chemotherapeutic drugs docetaxel (Taxotere(R)) or liposomal doxorubicin (Doxil(R)) resulted in a substantial increase in anti-tumor activity. The docetaxel plus PEGPH20 combination treatment demonstrated significantly enhanced survival compared to treatment with docetaxel alone. These results and other findings support initiation of a Phase 1, dose escalation, intravenous, PEGPH20 monotherapy trial that is expected to begin during the first half of 2009 in late stage, refractory cancer patients.
-- Baxter announced it submitted an IND to the FDA to conduct a Phase 3 clinical trial with GAMMAGARD LIQUID plus Halozyme's Enhanze(TM) Technology as a subcutaneous injection via a single site for the treatment of primary immune deficiency.
Third Quarter 2008 Financial Results
-- Net loss for the third quarter of 2008 was $10.9 million, or $0.14 per share, compared with a net loss for the third quarter of 2007 of $7.0 million, or $0.09 per share. Net loss for the nine months ended September 30, 2008 was $31.8 million, or $0.40 per share, compared with a net loss of $15.2 million, or $0.21 per share, for the comparable period last year.
-- Revenues for the third quarter of 2008 were $2.5 million, compared with $943,000 for the third quarter of 2007. Revenues under collaborative agreements for the third quarter of 2008 were $2.2 million, compared with $758,000 for the third quarter of 2007. Revenues under collaborative agreements in the third quarter of 2008 primarily consisted of the amortization of upfront fees received from Baxter and Roche of $588,000 and research and development reimbursements from Baxter of $847,000 and Roche of $760,000. Revenues under collaborative agreements for the third quarter of 2007 primarily consisted of the amortization of upfront fees received from Baxter and Roche of $477,000 and research and development reimbursements from Baxter of $66,000 and Roche of $214,000.
-- Research and development expenses for the third quarter of 2008 rose to $10.1 million, compared with $6.4 million for the third quarter of 2007, primarily due to an increase in research and development headcount, spending on the PEGPH20, insulin and dermatology clinical and pre-clinical programs, and production costs associated with the manufacturing scale-up of the rHuPH20 enzyme.
-- Selling, general and administrative expenses for the third quarter of 2008 were $3.5 million, compared with $2.8 million for the third quarter of 2007, reflecting increases in compensation expenses due to higher headcount.
-- Cash and cash equivalents totaled $72.5 million as of September 30, 2008, compared with $97.7 million as of December 31, 2007.
Halozyme management will host a conference call and webcast today to discuss these topics beginning at 1:30 p.m. PST (4:30 p.m. EST). To participate via telephone, please call 888-256-9044 for domestic callers or 706-643-5585 for international callers. The conference ID # is 71335335. A telephone replay will be available for 48 hours by dialing 800-642-1687 for domestic callers or 706-645-9291 for international callers. The conference call will be broadcast live over the Internet at http://www.halozyme.com and the replay will be available on the company's website for 30 days.
Upcoming Corporate Presentations
Halozyme management is scheduled to present at the following investment conferences:
-- Lazard Capital Markets 5th Annual Healthcare Conference to be held at the St. Regis Hotel in New York on Tuesday, November 18, 2008 at 2:40 p.m. EST (11:40 a.m. PST)
-- Piper Jaffray 20th Annual health Care Conference to be held at the New York Palace Hotel in New York on Wednesday, December 3, 2008 at 3:30 p.m. EST (12:30 p.m. PST).
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the drug delivery, endocrinology, oncology and dermatology markets. The company's portfolio of products and product candidates is based on intellectual property covering the family of human enzymes known as hyaluronidases. The company's Enhanze. Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Its key partnerships are with Roche to apply Enhanze Technology to Roche's biological therapeutic compounds for up to 13 targets and with Baxter to apply Enhanze Technology to Baxter's biological therapeutic product, GAMMAGARD LIQUID 10%. In addition, the company has received FDA approval for two products: Cumulase(R), for use in in-vitro fertilization, and HYLENEX, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. HYLENEX is partnered with Baxter International Inc. Halozyme also has a number of different enzymes in its portfolio that target significant areas of unmet medical need.
Safe Harbor Statement
In addition to historical information, the statements set forth above
include forward-looking statements (including, without limitation, (i)
statements relating to the benefits of a faster acting insulin product and
(ii) conclusions and implications drawn from clinical and pre-clinical
trial data for PEGPH20 and Chemophase) 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 THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - UNAUDITED
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2008 AND 2007
Three Months Ended Nine Months Ended
September 30, September 30,
2008 2007 2008 2007
agreements $2,194,325 $757,629 $5,209,897 $1,920,192
Product sales 267,901 185,252 492,066 541,420
Total Revenues 2,462,226 942,881 5,701,963 2,461,612
Cost of product
sales 130,720 59,454 205,036 211,200
development 10,080,775 6,352,397 27,450,454 13,265,645
and administrative 3,450,450 2,840,683 11,454,228 7,207,544
Expenses 13,661,945 9,252,534 39,109,718 20,684,389
LOSS FROM OPERATIONS (11,199,719) (8,309,653) (33,407,755) (18,222,777)
Interest income 327,561 1,280,871 1,579,210 3,034,985
NET LOSS $(10,872,158) $(7,028,782) $(31,828,545) $(15,187,792)
Basic and diluted
net loss per share $(0.14) $(0.09) $(0.40) $(0.21)
Shares used in
computing net loss
basic and diluted 80,293,800 76,502,867 79,383,614 73,259,130
HALOZYME THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
AS OF SEPTEMBER 30, 2008 AND DECEMBER 31, 2007
September 30, December 31,
Cash and cash equivalents $72,493,045 $97,679,085
Accounts receivable 1,495,855 779,825
Inventory 525,428 703,468
Prepaid expenses and other assets 3,715,018 2,014,680
Total current assets 78,229,346 101,177,058
Property and equipment, net 2,523,767 2,283,316
Total Assets $80,753,113 $103,460,374
LIABILITIES AND STOCKHOLDERS' EQUITY:
Accounts payable $4,140,976 $3,055,637
Accrued expenses 3,705,304 2,502,259
Deferred revenue 3,216,080 3,306,225
Total current liabilities 11,062,360 8,864,121
net of current portion 37,731,528 35,963,266
net of current portion 1,073,416 865,063
Common stock 81,113 77,904
Additional paid-in capital 127,628,664 122,685,443
Accumulated deficit (96,823,968) (64,995,423)
Total stockholders' equity 30,885,809 57,767,924
Total Liabilities and
Stockholders' Equity $80,753,113 $103,460,374
Halozyme Contact Media Contact
Robert H. Uhl Karen Sparks / Joleen Schultz
Senior Director, Investor Relations Mentus
(858) 704-8264 (858) 455-5500, x275/x215
|SOURCE Halozyme Therapeutics, Inc.|
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