CUPERTINO, Calif., Feb 10, 2005 /PRNewswire-FirstCall via COMTEX/ — DURECT Corporation
(Nasdaq: DRRX) announced today its financial results for the three months and
year ended December 31, 2004.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )
Our net loss for the three months ended December 31, 2004 was $7.0 million
or 13 cents per share, compared to a net loss of $5.3 million or 10 cents per
share for the same period in 2003. Our results for the three months ended
December 31, 2004 included non-cash charges for the amortization of intangible
assets and stock-based compensation of $329,000, compared to $373,000 for the
same period in 2003. Cash used in operating activities was $6.8 million for
the three months ended December 31, 2004, compared to $6.1 million for the
same period in 2003.
Our net loss for the year ended December 31, 2004 was $27.6 million or
54 cents per share, compared to a net loss of $22.7 million or 45 cents per
share for the same period in 2003. Our results for the year ended December 31,
2004 included non-cash charges for the amortization of intangible assets and
stock-based compensation of $1.5 million, compared to $1.2 million for the
same period in 2003. Cash used in operating activities was $22.2 million for
the year ended December 31, 2004, compared to $19.3 million for the same
period in 2003.
“We completed fiscal year 2004 by accomplishing the major objectives for
four out of five products in development. We currently have four programs in
clinical development, utilizing four different proprietary delivery platforms
— transdermal (TRANSDUR(TM)-based sufentanil patch), oral (ORADUR(TM)-based
oxycodone), injectable (SABER(TM)-based post-operative pain depot) and
biodegradable implantable (DURIN(TM)-based Alzheimer’s disease product),” said
James E. Brown, President and CEO of DURECT. “While we were disappointed with
the delay in our CHRONOGESIC(R) program, at the same time, we are proud to
have advanced four additional programs in to later stage clinical
development.”
Dr. Brown continued, “Earlier today, we were pleased to announce that we
met two established program milestones. We announced the completion of dosing
of the Phase I pharmacokinetic study for our TRANSDUR-based sufentanil patch.
We also announced that we have completed dosing of the first cohort of the
on-going Phase II trial for our SABER-based post-operative pain relief depot,
and we are actively enrolling patients in the second cohort. We continue to
receive strong interest from potential commercialization partners for these
two programs.”
Fourth Quarter and Fiscal Year 2004 Developments
TRANSDUR-based Sufentanil Pain Product Candidate
— In October 2004, we initiated a Phase I clinical study for our new
proprietary transdermal sufentanil product. The trial consists of a
pharmacokinetic study in normal, healthy volunteers in Europe. The objectives
of the clinical study are to determine the safety and tolerability of our
transdermal sufentanil patch as well as to evaluate the pharmacokinetics of
sufentanil following transdermal administration.
— Our transdermal sufentanil product is intended to provide extended
chronic pain relief for up to seven days, as compared to the three days of
relief provided with currently available opioid patches. Further, we
anticipate that the small size of our sufentanil patch (potentially as small
as 1/5th the size of currently marketed transdermal fentanyl patches for a
therapeutically equivalent dose) may offer improved convenience for patients.
SABER-based Post-Operative Pain Depot Product Candidate
— In October 2004, we initiated a Phase II clinical study for our
post-operative pain relief depot. This product candidate is a sustained
release injectable designed to provide up to 72 hours of post-surgical pain
relief and is based on our patented SABER delivery system.
— We anticipate that the trial would enroll approximately 60 patients,
with an option to enroll an additional 30 patients.
— The Phase II trial is a dose escalation study, conducted in three
cohorts, for the treatment of pain in patients following repair of inguinal
hernia. Patients are administered SABER-Bupivacaine at the completion of
surgery, and the trial will be used to evaluate the safety and efficacy of the
therapy.
— The study end points include a pharmacokinetic evaluation of plasma
bupivacaine levels, time to first supplemental analgesic, total supplemental
analgesics, and analysis of the sum of pain intensity and total pain relief.
Remoxy(TM) Product Candidate (Collaboration with Pain Therapeutics, Inc.)
— Pain Therapeutics initiated the Phase III program for Remoxy in
December 2004.
— Remoxy is a novel long-acting oral formulation of oxycodone based on
DURECT’s ORADUR technology, a proprietary oral sustained release technology
with several potential abuse deterrent properties.
CHRONOGESIC (Sufentanil) Pain Therapy Product Candidate (Collaboration
with Endo Pharmaceuticals)
— We continue to work on the system design of our CHRONOGESIC product in
order to resume clinical trials for this product.
— CHRONOGESIC is an osmotic implant that delivers sufentanil for the
treatment of chronic pain.
DURIN-based Leuprolide Alzheimer’s Disease Product Candidate
(Collaboration with Voyager Pharmaceutical Corporation)
— In December 2004, the FDA accepted an Investigational New Drug
Application and clinical protocol submitted by Voyager for a product candidate
for treating Alzheimer’s disease using our DURIN(TM) drug delivery platform.
— The trial consists of a pharmacokinetic study in normal, healthy
volunteers, the objectives of which are to determine the safety and
tolerability of the DURIN implant, as well as to evaluate the pharmacokinetic
profile of the active agent (leuprolide acetate) following administration of
the product candidate.
— Enrollment of the clinical trial was completed in January 2005.
Total revenues were $4.0 million and $13.9 million for the three months
and the year ended December 31, 2004 respectively, compared to $3.1 million
and $11.8 million for the same periods in 2003. The increase in total revenues
was primarily attributable to higher collaborative research and development
and milestone revenue recognized from our agreements with various strategic
partners as we continued to make progress on the collaboration programs.
Research and development expenses were $6.2 million and $24.2 million for
the three months and the year ended December 31, 2004 respectively, compared
to $4.7 million and $20.9 million for the same periods in 2003. The increases
were primarily attributable to the higher development costs related to our
SABER-based post-operative pain depot, TRANSDUR-based transdermal patch,
CHRONOGESIC and other partnered products under development. We initiated
clinical trials for both the SABER-based post-operative pain depot product
candidate and the TRANSDUR-based transdermal patch product candidate in the
fourth quarter of 2004.
Selling, general and administrative expenses were $2.9 million and
$9.7 million for the three months and the year ended December 31, 2004
respectively, compared to $1.9 million and $8.5 million for the same periods
in 2003. The increases were primarily attributable to direct internal and
external expenses, to comply with the Sarbanes-Oxley Act Section 404,
approximately $700,000 for fiscal year 2004, and higher employee related
costs.
Interest income was $317,000 and $1.2 million for the three months and the
year ended December 31, 2004 respectively, compared to $309,000 and $1.0
million for the same periods in 2003. The increase in interest income was
primarily the result of higher yields in our cash and investments. Interest
expense was $1.2 million and $4.5 million for the three months and the year
ended December 31, 2004 respectively, compared with $1.1 million and
$2.5 million for the same periods in 2003, which was primarily the result of
the interest expense on the $60.0 million convertible notes we issued in June
and July of 2003.
At December 31, 2004, we had cash and investments of $61.8 million,
including $2.8 million in restricted investments, compared with total cash and
investments of $85.2 million at December 31, 2003.
First Quarter and Fiscal Year 2005 Financial Guidance
— We expect total cash burn for the fiscal year 2005 to be in the range
of $26.0 million to $28.0 million, which includes interest payment of
$3.8 million for the convertible notes.
— We expect our net loss will range from $30.0 million to $32.0 million
or 58 to 62 cents per share for the fiscal year of 2005. Our estimates include
anticipated non-cash charges for the amortization of intangible assets and
stock-based compensation.
— We expect our net loss for the first quarter of 2005 will range from
$9.0 million to $10.0 million or 17 or 19 cents per share.
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceuticals systems
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 partners 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 three are in collaboration with pharmaceutical
partners. Additional information about DURECT is available at www.www.durect.com.
NOTE: CHRONOGESIC(R), SABER(TM), ORADUR(TM), DURIN(TM), TRANSDUR(TM) and
MICRODUR(TM) are trademarks of DURECT Corporation. Other referenced trademarks
belong to their respective owners.
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 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
these products. Further information regarding these and other risks is
included in DURECT’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2004 filed with the SEC on November 5, 2004 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 Year ended
December 31, December 31,
2004 2003 2004 2003
(unaudited) (unaudited) (unaudited) (audited)
Product revenue, net $1,515 $1,746 $6,416 $6,691
Collaborative research
and development and
other revenue 2,508 1,358 7,437 5,144
Total revenues 4,023 3,104 13,853 11,835
Operating expenses:
Cost of revenues 612 587 2,729 2,427
Research and
development 6,213 4,728 24,233 20,948
Selling, general
and administrative 2,922 1,895 9,747 8,498
Amortization of
intangible assets 303 334 1,249 1,343
Stock-based
compensation (1) 26 39 204 (102)
Total operating
expenses 10,076 7,583 38,162 33,114
Loss from operations (6,053) (4,479) (24,309) (21,279)
Other income (expense):
Interest income 317 309 1,236 1,041
Interest expense
and other (1,200) (1,089) (4,546) (2,460)
Net other expense (883) (780) (3,310) (1,419)
Loss before income
taxes (6,936) (5,259) (27,619) (22,698)
Income tax provision 18 -- 18 --
Net loss $(6,954) $(5,259) $(27,637) $(22,698)
Net loss per common
share, basic and
diluted $(0.13) $(0.10) $(0.54) $(0.45)
Shares used in
computing basic and
diluted net loss
per share 51,839 50,996 51,507 50,510
(1) Stock-based
compensation
related to the
following:
Cost of revenues $-- $3 $1 $18
Research and development 1 16 157 (210)
Selling, general and
administrative 25 20 46 90
$26 $39 $204 $(102)
DURECT CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
December 31, December 31,
2004 2003
(unaudited) (audited)
Assets
Current assets:
Cash and cash equivalents $20,032 $21,203
Short-term investments 21,765 39,511
Accounts receivable, net 2,481 1,968
Inventories 1,929 1,902
Prepaid expenses and other current assets 1,364 1,480
Total current assets 47,571 66,064
Property and equipment, net 7,112 9,316
Goodwill 6,399 6,399
Intangible assets, net 1,745 2,994
Long-term investments 17,218 21,334
Restricted investments 2,798 3,119
Other non-current assets 2,625 3,181
Total assets $85,468 $112,407
Liabilities and stockholders' equity
Current liabilities:
Accounts payable, accrued liabilities
and deferred revenue $5,006 $4,551
Long-term obligations, current portion 483 463
Total current liabilities 5,489 5,014
Long-term obligations, noncurrent portion 61,589 62,278
Stockholders' equity 18,390 45,115
Total liabilities and stockholders' equity $85,468 $112,407
SOURCE DURECT Corporation
investors, Schond L. Greenway, Executive Director, IR and Strategic Planning, or
media, Melissa M. Ta, Associate Director, Corporate Communications,
both of DURECT
Corporation, +1-408-777-1417
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