CUPERTINO, Calif., April 30 /PRNewswire/ —
DURECT Corporation (Nasdaq: DRRX) announced today financial results for the
three months ended March 31, 2001.
The company’s net loss attributable to common stockholders for the three
months ended March 31, 2001 was $4.9 million or 11 cents per share, compared
to $4.7 million, or 71 cents per share, for the three months ended March 31,
2000. DURECT’s results include non-cash charges for the amortization of
intangible assets and stock-based compensation of $1.2 million for the three
months ended March 31, 2001 and $1.2 million for the same period in 2000.
Commenting on the first quarter results, James E. Brown, CEO of DURECT
stated, “We are pleased with the company’s progress over the quarter. We have
completed patient enrollment for our Phase II clinical trial for DUROS
sufentanil more than three months ahead of schedule. We have a long-term
supply agreement with Mallinckrodt to supply DURECT’s clinical and commercial
requirements for sufentanil. The construction of our commercial manufacturing
facility is on track for completion in the second quarter of 2001. Each of
these accomplishments represents a significant step towards initiating our
Phase III clinical trial, and towards bringing our products to market. Today,
we also announced our acquisition of Southern BioSystems, a developer,
manufacturer and supplier of biodegradable polymer and non-polymer drug
delivery systems. With this acquisition, we have added three additional drug
delivery platforms, the SABER(TM) delivery system, microspheres and
drug-loaded implants, which will allow us to move additional products into
development. These technology platforms, which enable delivery of drugs from
days to months, are very complementary to our existing DUROS(R) business,
which has a therapeutic delivery profile from months to a year.”
The increase in net loss for the first quarter of 2001 compared to the
first quarter of 2000 was primarily due to increased research and development
activity, especially related to the company’s Phase II clinical trial for its
lead product, DUROS sufentanil. As a result of the early completion of
patient enrollment for this trial, the company accelerated related expenses in
the first quarter of 2001. The increase in operating expenses was offset by
increased interest income resulting from higher average outstanding cash
balances, and by an increase in gross profit resulting from product sales.
At March 31, 2001, the company had cash and investments of $102.1 million
compared to $41.1 million at March 31, 2000. This increase was primarily due
to the proceeds from the sale of common stock from DURECT’s initial public
offering, which closed on October 3, 2000.
DURECT Corporation is pioneering the development and commercialization of
pharmaceutical systems 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.
In addition to DUROS sufentanil, DURECT’s second product in development,
DUROS hydromorphone, is a DUROS-based pharmaceutical system for the delivery
of hydromorphone to the spine. DURECT is also selling FDA cleared catheters
for the delivery of fluids to the inner ear. DURECT also manufactures, sells
and distributes the ALZET(R) osmotic pump product for use in laboratory
research. SABER(TM) is a trademark of Southern BioSystems, Inc., a subsidiary
of DURECT Corporation.
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.
DUROS is a registered trademark of ALZA Corporation.
DURECT CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Quarter ended
March 31,
2001 2000
(unaudited) (unaudited)
Revenue, net $1,399 $83
Cost of goods sold (1) 611 36
Gross profit 788 47
Operating expenses:
Research and development 4,094 2,259
Research and development to
related party 47 262
Selling, general and
administrative 1,878 970
Amortization of intangible
assets 274 69
Stock-based compensation (1) 935 1,132
Total operating expenses 7,228 4,692
Loss from operations (6,440) (4,645)
Other income (expense):
Interest income 1,584 287
Interest expense (62) (21)
Net other income 1,522 266
Net Loss (4,918) (4,379)
Accretion of cumulative dividends on
Series B
convertible preferred stock -- (326)
Net loss attributable to common
stockholders $(4,918) $(4,705)
Net loss per common share, basic and
diluted $(0.11) $(0.71)
Shares used in computing basic and
diluted net loss per share 45,128 6,604
Pro forma net loss per share, basic
and diluted (2) $(0.14)
Shares used in computing pro forma
net loss per share (2) 30,653
(1) Stock-based compensation related to the following:
Cost of goods sold $22 $--
Research and development 680 705
Selling, general and administrative 255 427
$957 $1,132
(2) Pro forma calculations assume the conversion of all preferred stock,
at the date of issuance, into common stock.
DURECT CORPORATION
CONDENSED BALANCE SHEET
(in thousands)
March 31,
2001 2000
(unaudited)(unaudited)
Assets
Current assets:
Cash, cash equivalents and short-term
investments $85,036 $40,141
Inventories and other current assets 5,074 705
Total current assets 90,110 40,846
Property and equipment, net 5,724 1,578
Intangible assets, net 4,901 1,320
Long-term investments and
other non-current assets 17,090 1,256
Total assets $117,825 $45,000
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued liabilities $4,872 $1,455
Equipment financing obligations,
current portion 475 225
Total current liabilities 5,347 1,680
Equipment financing obligations,
noncurrent portion 961 611
Stockholders' equity 111,517 42,709
Total liabilities and stockholders' equity $117,825 $45,000
The statements in this press release regarding DURECT’s products in
development, product development plans, clinical trials, and expected product
benefits 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 develop, manufacture and commercialize
its products, complete successful clinical trials, obtain product approvals
from regulatory agencies, build a manufacturing facility, manage its growth
and costs, as well as marketplace acceptance of DURECT’s products. Further
information regarding these and other risks is included in the company’s S-1
registration statement, filed with the SEC on September 22, 2000, 424(b)
prospectus filed with the SEC on September 28, 2000, Quarterly Report on Form
10-Q for the quarter ended September 30, 2000 filed with the SEC on November
14, 2000 and Annual Report on Form 10-K for the fiscal year ended December 31,
2000 filed with the SEC on March 30, 2001.
| CONTACT: | For further information please contact: |
|---|---|
| DURECT Corporation | |
| Schond L. Greenway | |
| Director, Investor Relations | |
| Phone: 408-777-1417 | |
| schond.greenway@durect.com |
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SOURCE DURECT Corporation
CONTACT: Schond L. Greenway, Director, Investor Relations, DURECT
Corporation, 408-777-1417, schond.greenway@durect.com/