CUPERTINO, Calif., May 2 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced today financial results for the three months ended
March 31, 2006.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )
DURECT’s net loss for the three months ended March 31, 2006 was $6.3
million or 10 cents per share, compared to a net loss of $5.4 million or 10
cents per share for the same period in 2005. DURECT’s results for the three
months ended March 31, 2006 included non-cash charges for the amortization of
intangible assets and stock-based compensation of $1.2 million, compared to
$353,000 for the same period in 2005. Cash used in operating activities was
$3.3 million for the three months ended March 31, 2006, compared to $5.2
million for the same period in 2005.
“We continue to drive forward our development programs and carry the
momentum from 2005 into the first quarter of 2006. We are pleased with
development progress of Remoxy, an abuse-resistant, long-acting, oral pain
medication under development by Pain Therapeutics, Inc. and its
commercialization sub-licensee King Pharmaceuticals, Inc., based on DURECT’s
patented ORADUR(TM) technology, and the clarification of the pathway to
regulatory approval afforded by the Special Protocol Assessment received in
February 2006,” said Jim Brown, D.V.M., President and CEO of DURECT.
Dr. Brown continued, “We also continue to advance our post-operative pain
relief depot, SABER-Bupivacaine, development program. During 2006, our U.S.
IND was accepted by the FDA, we announced results from our Phase II Australian
clinical study in hernia patients and we initiated dosing in our first U.S.
clinical trial, a Phase II, placebo-controlled trial in hernia patients.”
Total revenues were $5.2 million for the three months ended March 31,
2006, compared to $5.4 million for the same period in 2005. Total
collaborative research and development and other revenues were $3.1 million
for the three months ended March 31, 2006, compared with $3.6 million for the
same period in 2005. The decrease in total revenues is primarily attributable
to lower collaborative research and development revenue recognized from our
agreements with Voyager Pharmaceutical Corporation and Endo Pharmaceuticals,
Inc., offset by higher product revenues from our ALZET product lines.
Research and development expenses were $7.2 million for the three months
ended March 31, 2006, compared to $6.7 million for the same period in 2005.
The increase was primarily attributable to the stock-based compensation
expense of $614,000 related to research and development personnel recognized
under SFAS 123R (Share-based Payments) in the first quarter of 2006.
Selling, general and administrative expenses were $3.0 million for the
three months ended March 31, 2006, compared to $2.5 million for the same
period in 2005. The increase in the three months ended March 31, 2006 was
primarily attributable to the higher product assessment and market research
related expenses as well as the stock-based compensation expense of $321,000
related to selling, general and administrative personnel recognized under SFAS
123R in the first quarter of 2006.
Interest and other income was $906,000 for the three months ended March
31, 2006, compared with $485,000 for the same period in 2005. The increase in
interest income was primarily the result of higher yields as well as higher
average cash and investment balances during the three months ended March 31,
2006 compared with the same period in 2005. Interest expense was $1.1 million
for the three months ended March 31, 2006 and 2005. The interest expense was
primarily due to the interest accrued on our convertible notes issued in 2003.
At March 31, 2006, DURECT had cash and investments of $87.9 million,
including $1.7 million in restricted investments, compared with cash and
investments of $91.0 million at December 31, 2005.
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceutical company focused
on the development of pharmaceutical systems based on its proprietary drug
delivery platform technologies. The company is developing pharmaceutical
systems to deliver the right drug to the right place in the right amount at
the right time to treat chronic and episodic diseases and conditions.
NOTE: SABER(TM), ORADUR(TM), DURIN(TM), TRANSDUR(TM) and MICRODUR(TM) are
trademarks of DURECT Corporation. Other referenced trademarks belong to their
respective owners.
DURECT Forward-Looking Statement
The statements in this press release regarding DURECT’s products in
development, product development plans 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 (and that of its third party collaborators where applicable)
abilities to design, enroll, conduct and complete clinical trials, complete
the design, development, and manufacturing process development of the product
candidate, obtain product and manufacturing approvals from regulatory agencies
and manufacture and commercialize the product candidate, as well as
marketplace acceptance of the product candidate. Further information regarding
these and other risks is included in DURECT’s Annual Report on Form 10-K for
the year ended December 31, 2005 filed with the SEC on March 16, 2006 under
the heading “Risk Factors.”
DURECT CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three months ended
March 31,
2006 2005
(unaudited) (unaudited)
Collaborative research and development
and other revenue $3,058 $3,597
Product revenue, net 2,153 1,757
Total revenues 5,211 5,354
Operating expenses:
Cost of revenues (1) 829 671
Research and development (1) 7,164 6,664
Selling, general and administrative (1) 3,005 2,508
Amortization of intangible assets 300 303
Total operating expenses 11,298 10,146
Loss from operations (6,087) (4,792)
Other income (expense):
Interest and other income 906 485
Interest expense (1,077) (1,120)
Net other loss (171) (635)
Net loss $(6,258) $(5,427)
Net loss per share, basic and diluted $(0.10) $(0.10)
Shares used in computing basic and diluted
net loss per share 61,837 51,887
(1) Stock-based compensation related to the following:
Cost of revenues $8 $--
Research and development 614 46
Selling, general and administrative 321 4
$943 $50
DURECT CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
March 31, December 31,
2006 2005 (1)
Assets
Current assets:
Cash and cash equivalents $44,093 $65,542
Short-term investments 29,731 18,022
Restricted investments 203 321
Accounts Receivable 3,164 4,488
Inventories 1,998 2,047
Prepaid expenses and other current assets 2,016 3,659
Total current assets 81,205 94,079
Property and equipment, net 7,580 7,304
Goodwill 6,399 6,399
Intangible assets, net 235 536
Long-term investments 12,330 5,459
Restricted investments 1,505 1,653
Other non-current assets 1,825 1,984
Total assets $111,079 $117,414
Liabilities and stockholders' equity
Current liabilities:
Accounts payable, accrued liabilities and
deferred revenue $8,114 $9,643
Long-term obligations, current portion 221 234
Total current liabilities 8,335 9,877
Long-term obligations, noncurrent portion 63,790 64,185
Stockholders' equity 38,954 43,352
Total liabilities and stockholders' equity $111,079 $117,414
(1) Derived from audited financial statements.
SOURCE:
DURECT Corporation
05/02/2006
CONTACT:
Schond L. Greenway, Vice President, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO