CUPERTINO, Calif., April 22 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced today financial results for the three months ended
March 31, 2004.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )
DURECT’s net loss for the three months ended March 31, 2004 was
$6.0 million or 12 cents per share, compared to a net loss of $5.9 million or
12 cents per share for the same period in 2003. DURECT’s results for the three
months ended March 31, 2004 included non-cash charges for the amortization of
intangible assets and stock-based compensation of $370,000, compared to
$181,000 for the same period in 2003. Cash used in operating activities was
$4.7 million for the three months ended March 31, 2004, compared to
$5.2 million for the same period in 2003.
“During the quarter, the Company completed feasibility studies to test and
measure the performance of a number of alternative prototype systems in
animals for our CHRONOGESIC(R) product, which we have partnered with Endo
Pharmaceuticals in the U.S. and Canada. Based on the data, we have identified
a number of possible solutions to address the premature shutdown. The results
thus far give us the confidence that this program remains on track, and we
anticipate that we will resume human clinical trials by the end of the year as
previously stated,” stated James E. Brown, DVM, President and CEO of DURECT.
Dr. Brown continued, “Additionally, we have been formulating our SABER(TM)
post-operative pain relief depot product with higher drug loadings in
preparation for Phase I/IIA studies anticipated later this year. We are also
formulating different compositions for different clinical settings. We held a
clinical advisory meeting with our Scientific Advisory Board composed of
relevant physician experts and thought leaders, where they provided valuable
input into our Phase I/IIA clinical trial protocol design. We are very pleased
at the level of interest that this product has received from our clinical
advisors, potential partners and physicians currently treating patients who
would be targeted for our product.”
“During the quarter, Phase I clinical testing began for Remoxy(TM), a
novel long-acting oral formulation of oxycodone that utilizes our SABER
technology and which is targeted to decrease the potential for oxycodone
abuse. This product is partnered with Pain Therapeutics, Inc., and we look
forward to the clinical results from this program.”
Total revenues were $3.4 million for the three months ended March 31,
2004, compared to $2.6 million for the same period in 2003. Total
collaborative research and development and other revenues were $2.0 million
for the three months ended March 31, 2004, compared with $1.1 million for the
same period in 2003. The increase in total revenues was primarily attributable
to higher collaborative research and development revenue recognized from our
agreements with Pain Therapeutics, Inc. and Voyager Pharmaceutical Corporation
and higher service revenue from our wholly-owned subsidiary, Absorbable
Polymers International Corporation (API), offset by lower product revenues
from our ALZET(R) and API product lines.
Research and development expenses were $5.4 million for the three months
ended March 31, 2004, compared to $5.6 million for the same period in 2003.
The decrease in the three months ended March 31, 2004 was primarily
attributable to the lower personnel expenses and consulting expenses compared
with the same period in 2003.
Selling, general and administrative expenses were $2.2 million for the
three months ended March 31, 2004, compared to $2.2 million for the same
period in 2003. There was no material difference in selling, general and
administrative expenses between the quarter ended March 31, 2004 and the
quarter ended March 31, 2003.
Interest income was $304,000 for the three months ended March 31, 2004,
compared with $241,000 for the same period in 2003. The increase in interest
income was primarily the result of higher cash and investment balances held
during the three months ended March 31, 2004, partially offset by a decline in
interest rates. Interest expense was $1.1 million for the three months ended
March 31, 2004 as compared to $124,000 for the same period in 2003. The
increase during the three months ended March 31, 2004 was primarily the result
of the interest accrued on the $60.0 million convertible notes the Company
issued in June and July of 2003.
At March 31, 2004, DURECT had cash and investments of $80.3 million,
including $3.0 million in restricted investments, compared with cash and
investments of $85.2 million at December 31, 2003.
DURECT expects its net loss for the second quarter of 2004 will range from
$7.0 million to $8.0 million or 14 to 16 cents per share.
About DURECT Corporation
DURECT Corporation (www.www.durect.com) 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 lead product in development is
CHRONOGESIC(R), a 3-month product for the treatment of chronic pain. DURECT
also owns three proprietary drug delivery platform technologies, including the
SABER(TM) Delivery System (a patented and versatile depot injectable useful
for protein and small molecule delivery), the MICRODUR(TM) Biodegradable
Microparticulates (microspheres injectable system) and the DURIN(TM)
Biodegradable Implant (drug-loaded implant system) upon which DURECT is
developing a pipeline of other products.
NOTE: CHRONOGESIC(R), ALZET(R), SABER(TM), MICRODUR(TM) and DURIN(TM) are
trademarks of DURECT Corporation. Remoxy(TM) is a trademark of Pain
Therapeutics, Inc.
The statements in this press release regarding DURECT’s products in
development, product development plans, anticipated clinical trials and
projected financial results are forward-looking statements involving risks and
uncertainties that can 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 complete the design, development,
and manufacturing process development of its products, manufacture and
commercialize its products, obtain product and manufacturing approvals from
regulatory agencies, manage its growth and expenses, manage relationships with
third parties, finance its activities and operations, as well as marketplace
acceptance of DURECT’s products. Further information regarding these and other
risks is included in DURECT’s Annual Report on Form 10-K for the fiscal year
ended December 31, 2003 filed with the SEC on March 11, 2004, DURECT’s
Quarterly Report on Form 10Q and other periodic reports filed with the SEC
under the heading “Factors that may affect future results.”
CHRONOGESIC, our post operative pain product, Remoxy and other products
mentioned above are under development and have not been submitted or approved
for commercialization by the US Food and Drug Administration or other health
authorities.
DURECT CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three months ended
March 31,
2004 2003
(unaudited) (unaudited)
Product revenue, net $1,365 $1,507
Collaborative research and development
and other revenue 2,020 1,074
Total revenues 3,385 2,581
Operating expenses:
Cost of revenues 565 595
Research and development 5,409 5,572
Selling, general and administrative 2,224 2,243
Amortization of intangible assets 335 335
Stock-based compensation(1) 35 (154)
Total operating expenses 8,568 8,591
Loss from operations (5,183) (6,010)
Other income (expense):
Interest income 304 241
Interest expense (1,111) (124)
Net other income (expense) (807) 117
Net loss $(5,990) $(5,893)
Net loss per share, basic and diluted $(0.12) $(0.12)
Shares used in computing basic and
diluted net loss per share 51,124 50,123
(1) Stock-based compensation related
to the following:
Cost of revenues $3 $8
Research and development 27 (236)
Selling, general and administrative 5 74
$35 $(154)
DURECT CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
March 31, December 31,
2004 2003(1)
Assets
Current assets:
Cash and cash equivalents $21,667 $21,203
Short-term investments 36,268 39,511
Accounts Receivable 2,626 1,968
Inventories 2,056 1,902
Prepaid expenses and other current assets 1,399 1,480
Total current assets 64,016 66,064
Property and equipment, net 8,792 9,316
Goodwill 6,399 6,399
Intangible assets, net 2,659 2,994
Long-term investments 19,374 21,334
Restricted investments 2,975 3,119
Other non-current assets 3,036 3,181
Total assets $107,251 $112,407
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued liabilities $5,219 $4,551
Long-term obligations, current portion 463 463
Total current liabilities 5,682 5,014
Long-term obligations, noncurrent portion 62,214 62,278
Stockholders' equity 39,355 45,115
Total liabilities and stockholders' equity $107,251 $112,407
(1) Derived from audited financial statements.
SOURCE DURECT Corporation
/CONTACT: Schond L. Greenway, Executive Director, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417/
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