CUPERTINO, Calif., July 22 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced today financial results for the three months ended
June 30, 2005.
DURECT’s net loss for the three months ended June 30, 2005 was $3.6
million or 7 cents per share, compared to a net loss of $7.4 million or 14
cents per share for the same period in 2004. DURECT’s results for the three
months ended June 30, 2005 included non-cash charges of $646,000 for the
amortization of intangible assets and stock-based compensation, compared to
$443,000 for the same period in 2004. Cash provided by operating activities
was $4.8 million for the three months ended June 30, 2005, compared to $6.3
million cash used for the same period in 2004.
“We had a very positive second quarter and executed on our corporate
objectives. We announced exciting preliminary results from cohort 2 of the
Phase II study for our post-operative pain relief depot,
SABER(TM)-Bupivacaine. In addition, we advanced this program into the third
and last cohort of the Phase II study, which is anticipated to enroll 60
patients. Also, our partner Pain Therapeutics announced the completion of
enrollment of their first Phase III study using our ORADUR sustained release
oral gel-cap technology, and we look forward to the results from this study,”
stated James E. Brown, DVM, President and CEO of DURECT.
Dr. Brown added, “We continue to make significant progress on our other
development programs, including our collaborations with Voyager with respect
to Alzheimer’s disease and ENDO with respect to our seven-day sufentanil
patch. Today, we also announced that we have taken the opportunity to retire a
portion of our outstanding convertible notes in order to further strengthen
our financial position.”
Total revenues were $8.8 million for the three months ended June 30, 2005,
compared to $3.1 million for the same period in 2004. Total collaborative
research and development and other revenues were $6.9 million for the three
months ended June 30, 2005, compared with $1.3 million for the same period in
2004. The increase in total revenues was primarily attributable to higher
collaborative research and development revenue recognized from our agreements
with Endo Pharmaceuticals, Inc. (TRANSDUR-sufentanil), Voyager Pharmaceutical
Corporation, and Pain Therapeutics, Inc. and higher product revenues from our
ALZET and polymer product lines.
Research and development expenses were $7.6 million for the three months
ended June 30, 2005, compared to $6.0 million for the same period in 2004.
The increase was primarily attributable to the higher development expenses for
SABER-Bupivacaine, TRANSDUR-Sufentanil, DURIN-Leuprolide and certain other
product candidates.
Selling, general and administrative expenses were $2.8 million for the
three months ended June 30, 2005, compared to $2.3 million for the same period
in 2004. The increase in the three months ended June 30, 2005 was primarily
due to higher employee related costs and other external costs to comply with
the Sarbanes-Oxley Act.
Interest and other income was $407,000 for the three months ended June 30,
2005, compared with $289,000 for the same period in 2004. The increase in
interest income was primarily the result of higher yields on cash and
investment balances held during the three months ended June 30, 2005 compared
with the same period in 2004. Interest expense was both $1.1 million for the
three months ended June 30, 2005 and 2004. The interest expense 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 June 30, 2005, DURECT had cash and investments of $60.5 million,
including $2.4 mil……..restricted investments, ……. with cash and
investments of $61.8 million at December 31, 2004. We anticipate that our
December 31, 2005 cash and investments balance to be in the range of $48.0
million to $50.0 million.
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 that treat chronic debilitating diseases and
enable biotechnology products. These platform technologies include the
SABER(TM) Delivery System (a patented and versatile depot injectable useful
for protein and small molecule delivery), the ORADUR(TM) sustained release
oral gel-cap technology (an oral sustained release technology with several
potential abuse deterrent properties), the DURIN(TM) Biodegradable Implant
(drug-loaded implant system), the TRANSDUR(TM) transdermal technology and the
MICRODUR(TM) Biodegradable Microparticulates (microspheres injectable system).
DURECT also collaborates with pharmaceutical companies to develop and
commercialize proprietary and enhanced pharmaceutical products based on its
technologies. DURECT has five disclosed on-going development programs of which
four are in collaboration with pharmaceutical partners. Additional information
about DURECT is available at www.www.durect.com.
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, 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 (and that of its third party collaborators
where applicable) abilities to 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 Quarterly Report on Form 10-Q for the period ended
March 31, 2005 filed with the SEC on May 6, 2005 under the heading “Factors
that may affect future results.”
DURECT CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three months ended Six months ended
June 30, June 30,
2005 2004 2005 2004
(unaudited) (unaudited) (unaudited) (unaudited)
Product revenue, net $1,889 $1,760 $3,646 $3,125
Collaborative research
and development and
other revenue 6,930 1,320 10,527 3,340
Total revenues 8,819 3,080 14,173 6,465
Operating expenses:
Cost of revenues 689 867 1,360 1,432
Research and
development 7,613 6,040 14,231 11,449
Selling, general
and administrative 2,812 2,339 5,316 4,563
Amortization of
intangible assets 303 308 606 643
Stock-based compensation(1) 343 135 393 170
Total operating expenses 11,760 9,689 21,906 18,257
Loss from operations (2,941) (6,609) (7,733) (11,792)
Other income (expense):
Interest and other income 407 289 892 593
Interest expense (1,114) (1,113) (2,234) (2,224)
Net other expense (707) (824) (1,342) (1,631)
Net loss $(3,648) $(7,433) $(9,075) $(13,423)
Net loss per common
share, basic and
diluted $ (0.07) $(0.14) $(0.17) $(0.26)
Shares used in computing
basic and diluted net
loss per share 52,047 51,396 51,967 51,260
--
(1) Stock-based compensation related to the following:
Cost of revenues $-- $(2) $-- $1
Research and development -- 126 46 153
Selling, general and
administrative 343 11 347 16
$343 $135 $393 $170
DURECT CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
June 30, December 31,
2005 2004 (1)
Assets
Current assets:
Cash and cash equivalents $30,269 $20,032
Short-term investments 18,918 21,765
Accounts receivable 6,166 2,481
Inventories 1,911 1,929
Prepaid expenses and other current assets 1,139 1,364
Total current assets 58,403 47,571
Property and equipment, net 7,258 7,112
Goodwill 6,399 6,399
Intangible assets, net 1,138 1,745
Long-term investments 8,926 17,218
Restricted investments 2,425 2,798
Other non-current assets 2,310 2,625
Total assets $86,859 $85,468
Liabilities and stockholders' equity
Current liabilities:
Accounts payable, accrued liabilities
and deferred revenue E.E...).612 $5,006
=.2.-.1.term obligations, current portion 366 483
Total current liabilities 7,978 5,489
Long-term obligations, noncurrent portion 68,647 61,589
Stockholders' equity 10,234 18,390
Total liabilities and stockholders' equity $86,859 $85,468
(1) Derived from audited financial statements.
SOURCE DURECT Corporation
07/22/2005
/CONTACT: Schond L. Greenway, Executive Director, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417/
/Web site: http://www.www.durect.com /