CUPERTINO, Calif., July 30 /PRNewswire/ —
DURECT Corporation (Nasdaq: DRRX) announced today financial results for the
three months ended June 30, 2001.
The company’s net loss attributable to common stockholders for the three
months ended June 30, 2001 was $7.0 million or 15 cents per share (excluding a
one-time, non-cash charge) compared to $5.2 million, or 65 cents per share,
for the three months ended June 30, 2000. DURECT incurred a one-time non-cash
charge of $14.0 million for acquired in-process research and development
associated with the acquisition of Southern BioSystems, Inc. that was
completed during the quarter. Including the one-time non-cash charge for
acquired in-process research and development, the company’s net loss was
$21.0 million. DURECT’s results for the period also include non-cash charges
for the amortization of intangible assets and stock-based compensation of
$1.4 million compared to $1.6 million for the same period in 2000.
“We are pleased with the company’s progress over the quarter. We have
completed our Phase II clinical trial for Chronogesic(TM) and completed
construction of our commercial manufacturing facility. Each of these
accomplishments represents a significant step towards initiating our Phase III
clinical trial, and towards bringing our products to market. In addition, we
received clearance for a special 510(k) pre-market notification with the FDA
for our next generation ear delivery catheter. The cleared catheter is used
by the Naval Medical Center San Diego as part of a blinded, placebo controlled
study evaluating the use of gentamicin for the treatment of Meniere’s
disease,” stated James E. Brown, CEO of DURECT. “We also announced our
acquisition of Southern BioSystems. 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 in the second quarter of 2001 compared to the
same quarter in 2000, excluding the one-time charge for acquired in-process
research and development, 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 June 30, 2001, the company had cash and investments of $94.2 million
compared to $106.1 million at December 31, 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.
Chronogesic(TM) is a trademark of DURECT Corporation. IntraEAR(TM) is a
registered trademark of DURECT Corporation. SABER(TM) is a trademark of
Southern BioSystems, Inc., a subsidiary of DURECT Corporation. DUROS is a
registered trademark of ALZA Corporation.
DURECT CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEET
(in thousands)
June 30, December 31,
2001 2000 (1)
(unaudited)
Assets
Current assets:
Cash, cash equivalents and short-term
investments $68,715 $104,432
Inventories and other current assets 5,794 4,881
Total current assets 74,509 109,313
Property and equipment, net 10,527 4,472
Intangible assets, net 11,186 5,175
Long-term investments and other
non- current assets 25,476 1,652
Total assets $121,698 $120,612
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued liabilities $4,947 $3,846
Other current liabilities 667 407
Total current liabilities 5,614 4,253
Other long term liabilities 2,498 1,105
Stockholders' equity 113,586 115,254
Total liabilities and stockholders'
equity $121,698 $120,612
(1) Derived from audited financial statements.
DURECT CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three months ended Six months ended
June 30, June 30,
2001 2000 2001 2000
(unaudited)(unaudited)(unaudited)(unaudited)
Revenue, net $1,687 $998 $3,086 $1,081
Cost of goods sold (1) 974 575 1,585 611
Gross profit 713 423 1,501 470
Operating expenses:
Research and development 5,315 2,983 9,409 5,242
Research and development to
related party 18 171 65 433
Selling, general and
administrative 2,157 1,003 4,035 1,973
Amortization of intangible
assets 461 233 735 302
Stock-based compensation (1) 919 1,367 1,854 2,499
Acquired in-process research
and development 14,030 -- 14,030 --
Total operating expenses 22,900 5,757 30,128 10,449
Loss from operations (22,187) (5,334) (28,627) (9,979)
Other income (expense):
Interest income 1,281 540 2,864 828
Interest expense (84) (33) (145) (55)
Net other income 1,197 507 2,719 773
Net loss (20,990) (4,827) (25,908) (9,206)
Accretion of cumulative dividends on
Series B convertible -- 326 -- 653
preferred stock
Net loss attributable to common
stockholders $(20,990) $(5,153) $(25,908) $(9,859)
Net loss per common share, basic and
diluted $(0.45) $(0.65) $(0.57) $(1.35)
Shares used in computing basic and
diluted net loss per share 46,325 7,958 45,726 7,279
Pro forma net loss attributable to
common stockholders excluding
acquired in-process research &
development $(6,960) $(11,878)
Pro forma net loss per share, basic
and diluted excluding
acquired in-process research &
development $(0.15) $(0.26)
Shares used in computing pro forma
net loss per share 46,325 45,726
(1) Stock-based compensation related
to the following:
Cost of goods sold $65 $21 $87 $21
Research and development 613 960 1,294 1,665
Selling, general and administrative 306 407 560 834
$984 $1,388 $1,941 $2,520
The statements in this press release regarding DURECT’s products in
development, product development plans, or 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,
successfully complete clinical trials, obtain product and manufacturing
approvals from regulatory agencies, and validate and qualify a manufacturing
facility, 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 April 30, 2001 filed with the SEC on May 11, 2001
and Annual Report on Form 10-K for the fiscal year ended December 31, 2000
filed with the SEC on March 30, 2001.
| Contact: | Schond L. Greenway, Director, Investor Relations of DURECT |
|---|---|
| Corporation, 408-777-1417, schond.greenway@durect.com. |
SOURCE DURECT Corporation
CONTACT: Schond L. Greenway, Director, Investor Relations of DURECT
Corporation, +1-408-777-1417, schond.greenway@durect.com./