(Nasdaq: DRRX) announced today financial results for the three months and year
development program (Chronogesic(R)) that we are no longer actively pursuing.
For the fiscal year ended
the year ended
for the same period in 2007.
compared with cash and investments of
including restricted investments of
ELADUR(TM) on attractive terms including a
strengthened our balance sheet through the elimination of our convertible
for 2009 include commencing the Phase III program with POSIDUR(TM), advancing
our other development programs in clinical studies, and pursuing favorable
collaborations around selected programs.”
— REMOXY. On
oxycodone) was submitted to the
August, this NDA filing was accepted and granted Priority Review by the FDA.
The FDA typically grants Priority Review to drug candidates that have the
potential to demonstrate significant improvements compared to marketed
Complete Response Letter from the FDA in
is not approved in its present form.
FDA believes additional non-clinical data will be required to support the
approval of REMOXY, but that the FDA has not requested or recommended
additional clinical efficacy studies prior to approval.
REMOXY, an investigational drug, is a long acting oral formulation of
oxycodone intended to treat moderate to severe pain. Based on
ORADUR(R) technology, which is covered by issued patents and pending patent
applications owned by us, REMOXY is designed to resist common methods of
prescription drug misuse and abuse.
— POSIDUR (SABER(TM)-Bupivacaine) Post-Operative Pain Relief Depot. We
continue to be in dialogue with the FDA regarding the Phase III program and
believe we are making progress in defining that program. In parallel with
these discussions, we and our European collaborator, Nycomed, continue to
advance development of this drug candidate. As one element in advancing the
program, because an orthopedic surgical model will be part of our proposed
studies for regulatory approval, in
Phase IIb study in
allow us to confirm aspects of our clinical study design and conduct.
Additionally, Nycomed prepared to commence Phase IIb studies in surgical
patient exposures that will ultimately be required by the FDA and the
POSIDUR is our post-operative pain relief depot that utilizes our patented
SABER technology to deliver bupivacaine to provide up to three days of pain
relief after surgery. POSIDUR is licensed to Nycomed for commercialization in
rights in the US,
— ELADUR (TRANSDUR(TM)-Bupivacaine). During 2008,
showing improved pain control with ELADUR versus placebo over the three day
treatment period in a Phase IIa study. We also received Orphan Drug
Designation, such that if ELADUR is the first bupivacaine product approved for
Post-Herpetic Neuralgia (PHN), ELADUR will receive seven years of market
exclusivity for PHN following its approval by the FDA.
exclusive worldwide rights to develop and commercialize ELADUR. This
Agreement became effective in
Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under this agreement,
Alpharma paid us an upfront license fee of
of 2008, with possible additional payments of up to
achievement of predefined development and regulatory milestones spread over
multiple clinical indications and geographical territories as well as possible
additional payments of up to
ELADUR is commercialized,
sales. Alpharma will control and fund the further development program.
ELADUR is our proprietary transdermal patch intended to deliver
bupivacaine for a period of up to three days from a single application.
commercialization of TRANSDUR-Sufentanil in the US and
II studies designed to evaluate the conversion of patients on oral opioids to
TRANSDUR-Sufentanil during 2008.
TRANSDUR-Sufentanil is our proprietary transdermal patch intended to
deliver sufentanil to chronic pain sufferers for a period of up to seven days
from a single application.
— Reduction in Convertible Notes. Our balance sheet was strengthened
during 2008 by the elimination of all of our
debt, which was converted into common stock in
terms of our indenture.
Financial Guidance for 2009 and Major Potential Milestones over the Next
— Financial Guidance. Our net cash consumption is heavily influenced by
the timing and structure of new corporate collaborations, as well as the
achievement of milestones under existing collaborations. While we anticipate
entering into new collaborations in 2009 and beyond, assuming no new
collaborations, no milestone payments and aggressive funding of our R&D
programs, many of which are in clinical development, we anticipate our net
cash consumption in 2009 will be approximately
— Business Development Activities. We have multiple late stage programs
that may potentially be partnered over the next 12-18 months. These include
Asia, as well as various internal programs which we have not described
publicly in detail.
— REMOXY. According to
technical advisors are evaluating the FDA Complete Response Letter and plan to
meet with the FDA in Q2 2009.
them with a more reliable context in which to make projections about REMOXY.
— POSIDUR. While not designed for statistical significance, we
anticipate having results from our on-going Phase IIb shoulder study by
mid-2009. We are continuing our dialogue with the FDA regarding our Phase III
program, and anticipate commencing that program in 2009.
— ELADUR. As the next step in developing this product candidate, we
anticipate that a Phase IIb study in PHN will be commenced in 2009.
— TRANSDUR-Sufentanil Patch.
commercialization of TRANSDUR-Sufentanil in the US and
they expect to hold an End-of-Phase II meeting with the FDA in early 2009.
Earnings Conference Call
A live audio webcast of a conference call to discuss 2008 results will be
broadcast live over the internet at
is available by accessing
clicking “Investor Relations.” If you are unable to participate during the
live webcast, the call will be archived on
Archive in the “Investor Relations” section.
innovative drugs for pain and other chronic diseases, with late-stage
development programs including REMOXY(R), POSIDUR(TM), ELADUR(TM), and
injectable depot delivery technologies enable new indications and superior
clinical/commercial attributes such as abuse deterrence, improved convenience,
compliance, efficacy and safety for small molecule and biologic drugs. For
more information, please visit http://www.www.durect.com.
NOTE: POSIDUR(TM), SABER(TM), ORADUR(R), TRANSDUR(TM), and ELADUR(TM) are
respective owners. REMOXY, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug
candidates under development and have not been approved for commercialization
DURECT Forward-Looking Statement
The statements in this press release under the heading “Financial Guidance
for 2009 and Major Potential Milestones over the Next 12-18 Months,” other
statements regarding development and potential uses of REMOXY, POSIDUR, ELADUR
and TRANSDUR-Sufentanil, and potential milestone payments or royalties based
on the sale of such products 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, delays and additional costs due to
requirements imposed by regulatory agencies,
party collaborators where applicable) difficulty or failure to obtain
approvals from regulatory agencies with respect to its development activities
and products, design, enroll, conduct and complete clinical trials, complete
the design, development, and manufacturing process development of the
referenced product candidates, consummate collaborative agreements relating to
our product candidates and technologies, manufacture and commercialize the
referenced product candidates, obtain marketplace acceptance of the referenced
product candidates, avoid infringing patents held by other parties and secure
and defend patents of our own, and manage and obtain capital to fund its
growth, operations and expenses. Further information regarding these and
other risks is included in
heading “Risk Factors.”
DURECT CORPORATION CONDENSED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (unaudited) Three months ended Year ended December 31, December 31, 2008 2007 2008 2007 Collaborative research and development revenue $4,715 $4,559 $17,192 $22,417 Product revenue, net 1,867 2,026 8,765 8,258 Total revenues 6,582 6,585 25,957 30,675 Operating expenses: Cost of revenues (1) 691 807 3,365 3,225 Research and development (1) 8,456 9,502 39,411 38,342 Selling, general and administrative (1) 3,684 3,262 15,462 13,618 Write down of deferred royalties and commercial rights 13,480 - 13,480 - Amortization of intangible assets 13 8 48 31 Total operating expenses 26,324 13,579 71,766 55,216 Loss from operations (19,742) (6,994) (45,809) (24,541) Other income (expense): Interest and other income 262 753 1,547 3,545 Interest expense (16) (475) (789) (2,625) Debt conversion expense - (495) - (718) Net other income (expense) 246 (217) 758 202 Net loss $(19,496) $(7,211) $(45,051) $(24,339) Net loss per share, basic and diluted $(0.24) $(0.10) $(0.58) $(0.35) Shares used in computing basic and diluted net loss per share 81,927 73,641 78,332 70,483 (1) Includes stock-based compensation related to the following: Cost of revenues $25 $32 $135 $130 Research and development 1,308 995 5,575 4,286 Selling, general and administrative 722 553 2,790 2,273 Total stock-based compensation $2,055 $1,580 $8,500 $6,689 DURECT CORPORATION Condensed Balance Sheet (in thousands) As of As of December 31, December 31, 2008 2007(1) (unaudited) ASSETS Current assets: Cash and cash equivalents $29,445 $37,589 Short-term investments 20,836 19,710 Accounts receivable 4,055 3,622 Inventories 3,475 1,963 Prepaid expenses and other current assets 1,849 1,904 Total current assets 59,660 64,788 Property and equipment, net 5,971 7,658 Goodwill 6,399 6,399 Intangible assets, net 157 180 Long-term investments 1,362 3,697 Restricted Investments 1,049 1,020 Other non-current assets 276 278 Total assets $74,874 $84,020 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $1,018 $1,834 Accrued liabilities 5,204 5,499 Contract research liability 995 1,946 Interest payable on convertible notes - 61 Deferred revenue, current portion 9,033 5,728 Equipment financing obligations, current portion 43 38 Bonds payable, current portion 240 225 Convertible subordinated notes due 2008 - 23,599 Other short-term liabilities 148 158 Total current liabilities 16,681 39,088 Bond payable and equipment financing obligations, noncurrent portion 60 343 Deferred revenue, noncurrent portion 21,118 9,268 Other long-term liabilities 596 740 Stockholders' equity 36,419 34,581 Total liabilities and stockholders' equity $74,874 $84,020 (1) Derived from audited financial statements.
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