CUPERTINO, Calif., Feb. 15 /PRNewswire/ —
DURECT Corporation (Nasdaq: DRRX) announced today financial results for the
three months and year ended December 31, 2000.
The Company’s net loss attributable to common stockholders for the three
months ended December 31, 2000 was $4.9 million or 11 cents per share,
compared to a net loss of $3.6 million, or 60 cents per share, for the three
months ended December 31, 1999. On a pro forma basis, DURECT’s net loss for
the three months ended December 31, 1999 was $3.3 million, or 11 cents per
share. For the year ended December 31, 2000, DURECT’s net loss was
$20.8 million, or $1.22 per share, compared to a net loss of $9.3 million, or
$1.76 per share, for the year ended December 31, 1999. On a pro forma basis,
the net loss for the year ended December 31, 2000 was $19.9 million, or
54 cents per share, compared to a net loss of $8.7 million, or 37 cents per
share, for the year ended December 31, 1999. Concurrent with the company’s
initial public offering on September 28, 2000, all shares of preferred stock
were converted into common stock. Pro forma calculations assume the conversion
of all preferred stock, at the date of issuance, into common stock. DURECT’s
results include non-cash charges for the amortization of intangible assets and
stock-based compensation of $1.4 million and $5.9 million for the fourth
quarter and the year ended December 31, 2000, respectively and $0.6 million
and $0.9 million for the same periods in 1999.
“We are pleased with the company’s progress over the past year. For the
year 2000, we met our key company milestones, including commencement of Phase
II clinical trials for our lead product, beginning construction on our
commercial manufacturing facility, and completing a prototype design for our
spinal delivery program for our second product, DUROS hydromorphone for
end-stage cancer pain. We completed two financings, including an initial
public offering of DURECT common stock, which together raised net proceeds of
approximately $109 million,” said James E. Brown, President and Chief
Executive Officer of DURECT. “We are also very pleased at the progress that we
have made in 2001 with our patient enrollment for our Phase II trial for DUROS
sufentanil. The accelerated pace exceeds our expectations, and we expect this
trial to complete 8-10 weeks ahead of the previously anticipated schedule.”
The increase in net loss for 2000 compared to the net loss in 1999 was
primarily due to the company’s preparation for and commencement of Phase II
clinical trials for its lead product, DUROS sufentanil, for the treatment of
chronic pain. The increases in operating expenses were primarily due to
increases in research and development expenses, selling, general and
administrative expenses and non-cash items including amortization and
stock-based compensation. The increase in research and development expenses
was attributable to activity related to DUROS sufentanil Phase II trials,
increases in research and development personnel and related payroll, and
increases in contract research and development. 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.
At December 31, 2000, the Company had cash, cash equivalents, and
investments of $106.1 million, compared to $18.9 million as of
December 31, 1999. This increase was primarily due to the proceeds from the
sale of common stock from DURECT’s initial public offering, which closed on
October 3rd, 2000.
The Company also announced that its 2001 Annual Meeting of Stockholders
has been scheduled for June 27, 2001.
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.
DURECT’s initial portfolio of products combine the DUROS technology, a proven
and patented drug delivery platform licensed for specified fields of use from
ALZA Corporation, with drugs for which medical data on efficacy and safety are
available.
DURECT’s lead product in development, DUROS sufentanil, is for the
treatment of chronic pain. DUROS sufentanil is designed to deliver sufentanil
on a continuous basis for 3 months for the treatment of chronic pain. Annual
sales of opioids for the treatment of chronic pain are in excess of
$1 billion. DURECT’s second product, DUROS hydromorphone, is a DUROS-based
pharmaceutical system for the delivery of hydromorphone to the spine for the
treatment of end-stage cancer pain. 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.
Founded in 1998, the Company 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.
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, marketplace acceptance of
DURECT’s products and DURECT’s ability to manage its growth and costs. 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 and its
424(b) prospectus filed with the SEC on September 28, 2000 and its Quarterly
Report on Form 10Q for the quarter ended September 30, 2000 filed with the SEC
on November 13, 2000.
There will be a conference call at 4:30 p.m. EST today to discuss DURECT’s
fourth quarter and year-end financial results as well as the outlook for 2001.
This call will be broadcast live over the Internet at http://www.www.durect.com
under “Investor Relations.” If you are unable to participate during the live
webcast, the call will be archived at:
http://www.www.durect.com/wt/frame.php?page_name=investor
Minimum Requirements to listen to broadcast: The RealPlayer software,
downloadable free from http://www.real.com/products/player/index.html, and at
least a 14.4Kbps connection to the Internet. If you experience problems
listening to the broadcast, send an email to webmaster@vdat.com.)
For further information please contact:
DURECT Corporation
Schond L. Greenway
Director, Investor Relations
Phone: (408) 777-1417
Schond.Greenway@durect.com
DURECT CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Quarter ended Year ended
December 31, December 31,
2000 1999 2000 1999*
(unaudited) (unaudited)
Revenue, net $973 $86 $3,155 $86
Cost of goods sold (1) 685 39 1,941 39
Gross profit 288 47 1,214 47
Operating expenses:
Research and development 4,028 2,069 12,669 5,181
Research and development
to related party 40 321 666 1,182
Selling, general and
administrative 1,504 644 4,874 2,109
Amortization of intangible
assets 342 69 850 69
Stock-based compensation
(1) 1,046 514 4,978 865
Total operating expenses 6,960 3,617 24,037 9,406
Loss from operations (6,672) (3,570) (22,823) (9,359)
Other income (expense):
Interest income 1,781 303 3,103 678
Interest expense (43) (7) (131) (27)
Net other income 1,738 296 2,972 651
Net Loss (4,934) (3,274) (19,851) (8,708)
Accretion of cumulative
dividends on Series B
convertible preferred stock -- 331 972 602
Net loss attributable
to common stockholders $(4,934) $(3,605) $(20,823) $(9,310)
Net loss per common share,
basic and diluted $(0.11) $(0.60) $(1.22) $(1.76)
Shares used in computing basic
and diluted net loss per share 44,126 6,000 17,120 5,291
Pro forma net loss per share,
basic and diluted $(0.11) $(0.54) $(0.37)
Shares used in computing pro
forma net loss per share 29,928 36,659 23,771
(1) Stock-based compensation
related to the following:
Cost of goods sold $22 $ -- $65 $ --
Research and development 741 316 3,426 485
Selling, general and
administrative 305 198 1,552 380
$1,068 $514 $5,043 $865
*derived from audited financial statements.
DURECT CORPORATION
CONDENSED BALANCE SHEETS
(in thousands)
December 31, December 31,
2000 1999*
(unaudited)
Assets
Current assets:
Cash, cash equivalents and short-
term investments $104,432 $16,598
Inventories and other current assets 4,881 869
Total current assets 109,313 17,467
Property and equipment, net 4,472 1,271
Intangible assets, net 5,175 1,390
Long-term investments 1,652 2,335
Total assets $120,612 $22,463
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued liabilities $3,846 $1,413
Equipment financing obligations,
current portion 407 133
Total current liabilities 4,253 1,546
Equipment financing obligations,
noncurrent portion 1,105 189
Stockholders' equity 115,254 20,728
Total liabilities and stockholders' equity $120,612 $22,463
*derived from audited financial statements.
SOURCE DURECT Corporation
CONTACT: Schond L. Greenway, Director, Investor Relations of DURECT
orporation, 408-777-1417, or Schond.Greenway@durect.com/