CUPERTINO, Calif., Oct. 31 /PRNewswire/ —
DURECT Corporation (Nasdaq: DRRX) announced today financial results for the
three months ended September 30, 2001.
The company’s net loss attributable to common stockholders for the
three months ended September 30, 2001 was $8.9 million or 19 cents per share
compared to $6.0 million, or 62 cents per share, for the three months ended
September 30, 2000. DURECT’s results for the period also include non-cash
charges for the amortization of intangible assets and stock-based compensation
of $1.3 million compared to $1.7 million for the same period in 2000.
“We are delighted with the company’s progress over the quarter,” stated
James E. Brown, CEO of DURECT. “During this quarter, we announced positive
Phase II results from our lead product in development, Chronogesic(TM), a
3-month continuous infusion subcutaneous implant for the treatment of chronic
pain. The results of the Phase II study exceeded our expectations. Patients
in the study reported that Chronogesic(TM) provided better pain control and
fewer side effects, resulting in a strong preference by patients for
Chronogesic(TM) versus other medicines used prior to the study. These
positive results support our belief that Chronogesic(TM) offers patients a
better quality-of-life alternative to currently available therapies for the
long-term treatment of stable and opioid responsive chronic pain.”
The increase in net loss in the third quarter of 2001 compared to the same
quarter in 2000 was primarily due to increased research and development
activity and selling, general and administrative expenses. The increase in
research and development expenses was primarily attributable to the company’s
Phase II clinical trial for its lead product, Chronogesic(TM). The increase in
selling, general and administrative expenses was primarily due to an increase
in general and administrative personnel and related expenses necessary to
support DURECT’s growth. The increase in operating expenses was partially
offset by increased interest income resulting from higher average outstanding
cash and investment balances.
At September 30, 2001, the company had cash and investments of
$88.2 million compared to $106.1 million at December 31, 2000.
DURECT Corporation is pioneering the development and commercialization of
pharmaceutical systems for the treatment of chronic debilitating diseases and
enabling biotechnology-based pharmaceutical products. DURECT’s goal is to
deliver the right drug to the right site in the right amount at the right
time. DURECT’s pharmaceutical systems combine technology innovations from the
medical device and drug delivery industries with proprietary pharmaceutical
and biotechnology drug formulations. These capabilities can enable new drug
therapies or optimize existing therapies based on a broad range of compounds,
including small molecule pharmaceuticals as well as biotechnology molecules
such as proteins, peptides and genes. DURECT focuses on the treatment of
chronic diseases including pain, CNS disorders, cardiovascular disease and
cancer. DURECT holds an exclusive license from ALZA Corporation (NYSE: AZA) to
develop and commercialize products in selected fields based on the DUROS(R)
implant technology. Chronogesic(TM), a 3-month continuous infusion
subcutaneous implant for the treatment of chronic pain, is the first product
in this series and completed phase II testing in June, 2001. DURECT also owns
three proprietary erodible implant platform technologies, including SABER(TM)
(a patented and versatile depot injectable useful for protein delivery),
microspheres and drug-loaded implants. DURECT also commercializes IntraEAR(R)
catheters which have been used by physicians to treat inner ear disorders.
Founded in 1998, DURECT is headquartered in Cupertino, CA. The company’s World
Wide Web site can be accessed at http://www.www.durect.com . To join DURECT’s
email alert service, please register by selecting “Email Alerts” on the main
Investor Relations web page at http://www.www.durect.com . Chronogesic(TM),
SABER(TM) and IntraEAR(R) are trademarks of DURECT Corporation. DUROS(R) is a
trademark of ALZA Corporation.
DURECT CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
Three months ended Nine months ended
September 30, September 30,
2001 2000 2001 2000
Revenue, net $1,841 $1,101 $4,928 $2,182
Cost of goods sold (A) 963 645 2,548 1,256
Gross profit 878 456 2,380 926
Operating expenses:
Research and development 7,181 3,400 16,590 8,648
Research and development
to related party 25 193 90 626
Selling, general and
administrative 2,305 1,398 6,339 3,363
Amortization of intangible
assets 555 206 1,290 508
Stock-based compensation (A) 750 1,432 2,605 3,932
Acquired in-process research
and development -- -- 14,030 --
Total operating expenses 10,816 6,629 40,944 17,077
Loss from operations (9,938) (6,173) (38,564) (16,151)
Other income (expense):
Interest income 1,096 495 3,960 1,322
Interest expense (92) (34) (238) (88)
Net other income 1,004 461 3,722 1,234
Net loss (8,934) (5,712) (34,842) (14,917)
Accretion of cumulative
dividends on Series B
convertible preferred stock -- 319 -- 972
Net loss attributable
to common stockholders $(8,934) $(6,031) $(34,842) $(15,889)
Net loss per common share,
basic and diluted $(0.19) $(0.62) $(0.76) $(1.96)
Shares used in computing basic
and diluted net loss per share 46,906 9,802 46,120 8,118
Pro forma net loss attributable
to common stockholders excluding
acquired in-process
research & development $(20,811)
Pro forma net loss per share,
basic and diluted excluding
acquired in-process
research & development $(0.45)
Shares used in computing
pro forma net loss
per share 46,120
(A) Stock-based compensation
related to the following:
Cost of goods sold $31 $22 $118 $43
Research and development 503 1,020 1,798 2,685
Selling, general and administrative 247 412 807 1,247
$781 $1,454 $2,723 $3,975
DURECT CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEET
(in thousands)
September 30, December 31,
2001 2000 (A)
Assets (unaudited)
Current assets:
Cash, cash equivalents and
short-term investments $69,397 $104,432
Accounts receivable, net 1,054 1,261
Inventories 2,052 2,682
Other current assets 1,848 938
Total current assets 74,351 109,313
Property and equipment, net 11,456 4,472
Intangible assets, net 10,631 5,175
Long-term investments and other 18,839 1,652
Total assets $115,277 $120,612
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued expenses $6,079 $3,846
Other current liabilities 678 407
Total current liabilities 6,757 4,253
Other long-term liabilities 2,405 1,105
Stockholders' equity 106,115 115,254
Total liabilities and stockholders' equity $115,277 $120,612
(A) Derived from audited financial statements.
The statements in this press release regarding DURECT’s products in
development, product development plans, expected product benefits or potential
product markets are forward-looking statements involving risks and
uncertainties that could cause actual results to differ materially from those
in such forward-looking statements. Potential risks and uncertainties include,
but are not limited to, DURECT’s ability to successfully complete clinical
trials, develop, manufacture and commercialize its products, obtain product
and manufacturing approvals from regulatory agencies, validate and qualify a
manufacturing facility and manage its growth and expenses, as well as
marketplace acceptance of DURECT’s products. Further information regarding
these and other risks is included in DURECT’s Quarterly Report on Form 10-Q
for the quarter ended June 30, 2001 filed with the SEC on August 14, 2001, and
Annual Report on Form 10-K for the fiscal year ended December 31, 2000 filed
with the SEC on March 30, 2001, under the heading “Factors that may effect
future results.”
SOURCE DURECT Corporation
CONTACT: Schond L. Greenway, Senior Director, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417, or
schond.greenway@durect.com/