CUPERTINO, Calif., Aug 07, 2007 /PRNewswire-FirstCall via COMTEX News Network/ — DURECT Corporation
(Nasdaq: DRRX) announced today financial results for the three months ended
June 30, 2007. Total revenues were $13.4 million for the three months ended
June 30, 2007, compared to $6.1 million for the same period in 2006; revenues
in the second quarter of 2007 include the earning of an $8.0 million milestone
payment under our Nycomed collaboration related to the clinical development of
POSIDUR(TM). Net loss for the three months ended June 30, 2007 was $479,000,
compared to a net loss of $8.7 million for the same period in 2006. Cash used
in operating activities was $6.1 million for the three months ended June 30,
2007, compared to $10.2 million in the three months ended June 30, 2006. At
June 30, 2007, we had cash and investments of $65.8 million, including $1.3
million in restricted investments, compared with cash and investments of $81.6
million at December 31, 2006. Cash flow in the second quarter of 2007 and the
reported cash and investments balance at June 30, 2007 do not reflect the $8.0
million milestone payment that had been earned but not received as of June 30,
2007; this payment was received on August 1, 2007.
Based on our financial results in the first half of 2007, the receipt of
an $8.0 million milestone payment from Nycomed and a reexamination of
anticipated financial results in the second half of 2007, we are now providing
revised financial guidance for cash burn in 2007 of approximately $25-27
million as compared to prior guidance of $32-36 million. This reforecast
continues to assume no major new collaborations during 2007, although we are
pursuing potential collaborations on multiple fronts including ELADUR,
TRANSDUR-Sufentanil for Europe and Asia, POSIDUR for Asia, as well as various
other programs.
“Our development programs continued to progress in the second quarter of
this year, as evidenced by positive results from our POSIDUR Phase IIb hernia
study, completion of enrollment in the Remoxy(TM) pivotal Phase III trial and
the initiation by Endo of their Phase II program with our TRANSDUR(TM)-
Sufentanil patch,” stated James E. Brown, D.V.M., President and CEO of DURECT.
“We expect further clinical developments in the second half of 2007 with
respect to POSIDUR, Remoxy and ELADUR.”
Recent Company Highlights:
POSIDUR. We recently announced positive results from a 122 patient
Phase IIb clinical trial in which POSIDUR at a dose of 5 mL
demonstrated statistically significant reductions in post-operative
pain (by approximately 30% versus placebo) and in total consumption of
supplemental opioid analgesic medications (approximately 3x less
versus placebo) in patients undergoing inguinal hernia repair. This
Phase IIb trial was designed to be the study upon which we and our
collaborator Nycomed would base our decision for advancing POSIDUR
into Phase III clinical trials. These successful results triggered an
$8 million milestone payment by Nycomed to DURECT under the parties’
collaborative agreement. We have scheduled an end-of-Phase II meeting
with the U.S. Food & Drug Administration (FDA).
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. 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. According to Pain Therapeutics and King Pharmaceuticals, the
Remoxy Phase III pivotal study is now fully enrolled and top-line
results of this study are expected in the fourth quarter of 2007.
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 FDA. Remoxy is licensed to Pain
Therapeutics, which has in turn sublicensed commercialization rights
to King Pharmaceuticals.
TRANSDUR(TM)-Sufentanil. According to its public disclosures, Endo
Pharmaceuticals commenced its Phase II program in June 2007.
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. TRANSDUR-Sufentanil is
licensed to Endo for commercialization in the US and Canada, and
DURECT has retained commercialization rights for the rest of the
world.
ELADUR(TM) (TRANSDUR-Bupivacaine). We are enrolling patients and
expect to report data in 2007 from a Phase IIa trial designed to
assess safety as well as the magnitude, duration and characteristics
of analgesic activity of ELADUR in approximately 50 patients with
Post-Herpetic Neuralgia (PHN).
ELADUR is our proprietary transdermal patch intended to provide
bupivacaine for a period of up to three days from a single
application. DURECT retains full commercial rights to this drug
candidate.
Earnings Conference Call
A live audio webcast of a conference call to discuss second quarter 2007
results will be broadcast live over the internet at 4:30 p.m. Eastern Time and
is available by accessing DURECT’s homepage at www.www.durect.com and clicking
“Investor Relations.” If you are unable to participate during the live
webcast, the call will be archived on DURECT’s website under Audio Archive in
the “Investor Relations” section.
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), 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 our products in
development, product development plans, our intended end-of-Phase II meeting
with the FDA and other anticipated regulatory, clinical and development
milestones and timing thereof, future clinical trial results, our intended
emergence as a specialty pharmaceutical company and anticipated 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, our (and that of our 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 our growth, operations and expenses. Further
information regarding these and other risks is included in our Form 10-Q filed
on May 9, 2007 under the heading “Risk Factors.”
DURECT CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
Three months ended Six months ended
June 30, June 30,
2007 2006 2007 2006
Collaborative research and
development revenue $3,408 $4,048 $6,866 $7,106
Milestone revenue 8,000 -- 8,000 --
Product revenue, net 2,024 2,060 4,292 4,213
Total revenues 13,432 6,108 19,158 11,319
Operating expenses:
Cost of revenues (1) 778 770 1,638 1,599
Research and development (1) 9,630 8,549 19,982 15,713
Selling, general and
administrative (1) 3,683 3,189 7,221 6,194
Amortization of intangible
assets 8 94 15 394
Total operating expenses 14,099 12,602 28,856 23,900
Loss from operations (667) (6,494) (9,698) (12,581)
Other income (expense):
Interest and other income 908 978 1,886 1,884
Interest expense (720) (932) (1,434) (2,009)
Debt conversion expense -- (2,287) -- (2,287)
Net other income (expense) 188 (2,241) 452 (2,412)
Net loss $(479) $(8,735) $(9,246) $(14,993)
Net loss per share,
basic and diluted $(0.01) $(0.14) $(0.13) $(0.24)
Shares used in computing
basic and diluted net loss
per share 69,364 64,207 69,298 63,040
(1) Includes stock-based compensation related to the following:
Cost of revenues 33 $18 $67 $26
Research and development 1,097 697 2,253 1,311
Selling, general and
administrative 555 323 1,223 644
Total stock-based
compensation $1,685 $1,038 $3,543 $1,981
DURECT CORPORATION
CONDENSED BALANCE SHEETS
(in thousands)
As of As of
June 30, 2007 December 31, 2006 (1)
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $32,231 $41,554
Short-term investments 29,342 28,297
Accounts receivable 11,658 2,152
Inventories 2,039 2,052
Prepaid expenses and other
current assets 2,054 1,744
Total current assets 77,324 75,799
Property and equipment, net 7,769 7,451
Goodwill 6,399 6,399
Intangible assets, net 96 111
Long-term investments 2,947 10,472
Restricted Investments 1,284 1,284
Other non-current assets 740 969
Total assets $96,559 $102,485
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $1,123 $864
Accrued liabilities 5,210 4,522
Contract research liability 2,168 1,624
Interest payable on convertible notes 97 97
Deferred revenue, current portion 5,324 5,348
Equipment financing obligations,
current portion 36 34
Bonds payable, current portion 210 210
Other short-term liabilities 141 --
Total current liabilities 14,309 12,699
Bond payable and equipment
financing obligations,
noncurrent portion 587 606
Convertible subordinated notes
due 2008 37,337 37,337
Deferred revenue, noncurrent portion 11,887 14,507
Other long-term liabilities 498 304
Stockholders' equity 31,941 37,032
Total liabilities and
stockholders' equity $96,559 $102,485
(1) Derived from audited financial statements.
SOURCE DURECT Corporation
Matthew J. Hogan,
Chief Financial Officer
of DURECT Corporation,
+1-408-777-4936;
or
Media,
Jeremiah Hall,
Senior Vice President of Feinstein Kean Healthcare,
+1-415-677-2700,
jeremiah.hall@fkhealth.com,
for DURECT Corporation
http://www.www.durect.com/