CUPERTINO, Calif., May 7 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced today financial results for the three months ended
March 31, 2007. Total revenues were $5.7 million for the three months ended
March 31, 2007, compared to $5.2 million for the same period in 2006. Net
loss for the three months ended March 31, 2007 was $8.8 million, compared to a
net loss of $6.3 million for the same period in 2006.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )
At March 31, 2007, DURECT had cash and investments of $72.4 million,
including $1.3 million in restricted investments, compared with cash and
investments of $81.6 million at December 31, 2006.
“Our development programs continued to progress in the first quarter of
this year, several of which should report clinical results during the course
of 2007,” stated James E. Brown, D.V.M., President and CEO of DURECT. “In
addition, with our entry into global supply agreements with Hospira Worldwide
for POSIDUR(TM) and Corium International for ELADUR(TM) (TRANSDUR-
Bupivacaine), we have secured product supply for late stage clinical trials
and launch of these drug candidates.”
Recent Pipeline Highlights:
- POSIDUR. POSIDUR is our post-operative pain relief depot that
utilizes our patented SABER(TM) technology to deliver bupivacaine to
provide up to three days of pain relief after surgery. At this
point, we have completed enrollment in the majority of studies in
our multiple-trial Phase II program in the U.S. and in other
countries. For the trials that have completed enrollment, the
treatment phases have been completed, and data collection is
underway. These studies were carried out in a variety of soft-
tissue and orthopedic surgeries for the purpose of selecting the
optimal dosing and the surgical procedures for our pivotal Phase III
trials. We anticipate reporting on these Phase II trials later in
the year and continue to target initiation of Phase III trials in
2007. Hospira, our worldwide supplier for POSIDUR, conducted
manufacturing runs during the first quarter. POSIDUR is licensed to
Nycomed for commercialization in Europe and select other countries,
and DURECT has retained commercialization rights in the US, Canada
and Asia. - Remoxy(TM). Remoxy, an abuse-resistant long-acting form of
oxycodone based on our ORADUR(TM) technology intended for the
treatment of chronic pain, is currently in a pivotal Phase III trial
in accordance with a Special Protocol Assessment (SPA) with the
United States Food and Drug Administration (FDA). Remoxy is
licensed to Pain Therapeutics, which has in turn sublicensed
commercialization rights to King Pharmaceuticals. According to Pain
Therapeutics, the Remoxy(TM) Phase III pivotal study is now over 80%
enrolled. - TRANSDUR(TM)-Sufentanil. TRANSDUR-Sufentanil is our proprietary
transdermal patch intended to provide sufentanil for a period of up
to seven days from a single application for chronic pain sufferers.
Based on its public disclosures, Endo Pharmaceuticals expects to
commence additional Phase II studies in the first half of 2007 using
patches manufactured by 3M Company. TRANSDUR-Sufentanil is licensed
to Endo for commercialization in the US and Canada, and DURECT has
retained commercialization rights to the rest of the world. - ELADUR (TRANSDUR-Bupivacaine). ELADUR is our proprietary
transdermal patch intended to provide bupivacaine for a period of up
to three days from a single application. During the first quarter
of 2007, we announced that we had begun a Phase II program for
ELADUR in the US under an FDA-accepted Investigational New Drug
(IND) application with a randomized, multi-center, double blind,
placebo controlled, two-way cross-over trial in approximately 50
patients with Post-Herpetic Neuralgia (PHN) to assess safety as well
as the magnitude, duration and characteristics of analgesic activity
of ELADUR. We expect to report data from this Phase II study in
2007. Corium, our worldwide supplier for ELADUR, conducted
manufacturing development activities during the first quarter of
2007. DURECT retains full commercial rights to this drug candidate. - Memryte(TM). Memryte is a drug candidate for the treatment of
Alzheimer’s Disease based on our proprietary DURIN(TM) implant
technology and Voyager Pharmaceutical’s patented method of treatment
of Alzheimer’s Disease. Voyager informed DURECT in the fourth
quarter of 2006 that Voyager had truncated its Phase III clinical
trial for Memryte in order to get an early look at potential
efficacy. According to Voyager, data analysis is underway and data
from this truncated trial is expected to be available in the first
half of 2007.
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceutical company
developing pharmaceutical systems based on its proprietary drug delivery
platform technologies. The Company currently has a number of late-stage
pharmaceutical products in development addressing large markets in pain
management, with a number of research programs underway targeting chronic
disease and other therapeutic areas. For more information, please visit
www.www.durect.com.
NOTE: POSIDUR(TM), SABER(TM), ORADUR(TM), DURIN(TM), TRANSDUR(TM), and
ELADUR(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, anticipated regulatory, clinical and
development milestones and timing thereof, future clinical trial results and
DURECT’s emergence as a specialty pharmaceutical company 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, manufacture and
commercialize the product candidate and manage and obtain capital to fund its
growth, operations and expenses. Further information regarding these and other
risks is included in DURECT’s Form 10-K filed on March 15, 2007 under the
heading “Risk Factors.”
DURECT CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
Three months ended
March 31,
2007 2006
Collaborative research and
development and other revenue $3,458 $3,058
Product revenue, net 2,268 2,153
Total revenues 5,726 5,211
Operating expenses:
Cost of revenues (1) 860 829
Research and development (1) 10,352 7,164
Selling, general and
administrative (1) 3,538 3,005
Amortization of intangible assets 7 300
Total operating expenses 14,757 11,298
Loss from operations (9,031) (6,087)
Other income (expense):
Interest and other income 978 906
Interest expense (714) (1,077)
Net other income (expense) 264 (171)
Net loss (8,767) (6,258)
Net loss per common share, basic and
diluted $(0.13) $(0.10)
Shares used in computing basic and
diluted net loss per share 69,231 61,837
(1) Includes stock-based compensation related
to the following:
Cost of revenues $34 $8
Research and development 1,156 614
Selling, general and administrative 668 321
$1,858 $943
DURECT CORPORATION
CONDENSED BALANCE SHEETS
(in thousands)
As of As of
March 31, December 31,
2007 2006
(unaudited) (1)
ASSETS
Current assets:
Cash and cash equivalents $33,386 $41,554
Short-term investments 34,800 28,297
Accounts receivable, net 4,674 2,152
Inventories 2,042 2,052
Prepaid expenses and other current assets 1,565 1,744
Total current assets 76,467 75,799
Property and equipment, net 7,429 7,451
Goodwill 6,399 6,399
Intangible assets, net 104 111
Long-term investments 2,948 10,472
Restricted investments 1,284 1,284
Other non-current assets 855 969
Total assets $95,486 $102,485
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $922 $864
Accrued liabilities 3,586 4,522
Contract research liability 3,125 1,624
Interest payable on convertible notes 681 97
Deferred revenue, current portion 5,254 5,348
Equipment financing obligations,
current portion 35 34
Bonds payable, current portion 210 210
Total current liabilities 13,813 12,699
Bonds payable and equipment financing
obligations, noncurrent portion 597 606
Convertible subordinated notes 37,337 37,337
Deferred revenue, noncurrent portion 13,197 14,507
Other long-term liabilities 273 304
Stockholders' equity 30,269 37,032
Total liabilities and stockholders' equity $95,486 $102,485
(1) Derived from audited financial statements.
SOURCE DURECT Corporation
05/07/2007
CONTACT: Matthew J. Hogan, Chief Financial Officer of DURECT
Corporation, +1-408-777-4936; or Jeremiah Hall, Senior Vice President of
Feinstein Kean Healthcare, +1-415-677-2700, jeremiah.hall@fkhealth.com
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
Web site: http://www.www.durect.com
(DRRX)