CUPERTINO, Calif., Feb. 5 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced today financial results for the three months and year
ended December 31, 2007. Total revenues were $6.6 million for the three months
ended December 31, 2007, compared to $5.4 million for the same period in 2006.
Net loss for the three months ended December 31, 2007 was $7.2 million,
compared to a net loss of $9.8 million for the same period in 2006.
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For the fiscal year ended December 31, 2007, total revenues were
$30.7 million, compared to $21.9 million for the same period in 2006. Net
loss for the year ended December 31, 2007 was $24.3 million, compared to a net
loss of $33.3 million for the same period in 2006.
At December 31, 2007, DURECT had cash and investments of $62.0 million,
compared with cash and investments of $81.6 million at December 31, 2006;
these figures include restricted investments of $1.0 million at December 31,
2007 and $1.3 million at December 31, 2006. DURECT’s net decrease in cash
during 2007 was $19.6 million.
“DURECT’s pipeline advanced during 2007, reporting positive clinical trial
results for three programs in Phase III or II. We expect to continue this
progress in 2008 as we look forward to the filing of the first New Drug
Application (NDA) based on our ORADUR(TM) technology and further advancing our
late stage programs,” stated James E. Brown, D.V.M., President and CEO of
DURECT. “Remoxy(TM) met the primary endpoint in its pivotal Phase III study
conducted under a Special Protocol Assessment (SPA), POSIDUR(TM) reported
statistically significant improvements in pain control while reducing the use
of narcotics in a Phase IIb hernia study, and ELADUR(TM) showed improved pain
control versus placebo over the three day treatment period in a Phase IIa
study. Each of these programs addresses large market opportunities with
product features that offer clear advantages over existing therapeutics.”
Highlights for DURECT in Fiscal Year 2007 include:
— Remoxy. In December, our collaborators King Pharmaceuticals and Pain
Therapeutics announced that the pivotal Phase III trial for Remoxy
successfully met its primary endpoint (p<0.01) that was prospectively
defined by the U.S. Food and Drug Administration (FDA) during the SPA
process. In addition, the study achieved statistically significant
results in secondary endpoints such as Quality of Analgesia (p<0.01)
and Global Assessment (p<0.01). No drug related safety issues were
noted in the study.
Remoxy is an abuse-resistant, long-acting form of oxycodone based on
our ORADUR(TM) technology intended for the treatment of chronic pain.
— POSIDUR Post-Operative Pain Relief Depot. In July, we 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. These successful results triggered an $8 million
milestone payment by Nycomed to DURECT under the parties’ international
collaborative agreement. We have held an end-of-Phase II meeting with
the U.S. Food & Drug Administration (FDA) and are in dialogue with the
FDA regarding the Phase III program. Hospira, our manufacturer of
POSIDUR, has produced supplies for Phase III clinical trials.
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.
— ELADUR (TRANSDUR(TM)-Bupivacaine). In December, we announced positive
results from a 60 patient Phase IIa clinical trial. In this study of
patients suffering from post-herpetic neuralgia, ELADUR showed improved
pain control versus placebo during the 3-day continuous treatment
period. In addition, ELADUR appeared to be well tolerated overall, and
patients treated with ELADUR and placebo exhibited similar safety
profiles. We have in place a relationship with Corium International,
whereby Corium will be our worldwide supplier of ELADUR patches.
ELADUR is our proprietary transdermal patch intended to provide
bupivacaine for a period of up to three days from a single application.
We retain full commercial rights to this drug candidate.
— TRANSDUR-Sufentanil. Endo Pharmaceuticals, our licensee for
commercialization in the US and Canada, has publicly disclosed that
they have commenced their Phase II program in June 2007.
TRANSDUR-Sufentanil is our proprietary transdermal patch intended to
provide sufentanil to chronic pain sufferers for a period of up to
seven days from a single application.
— Expansion of Patent Portfolio. In the fourth quarter of 2007, we
acquired from a third party a portfolio of worldwide patents relating
to drug delivery technologies. This portfolio consists of
approximately 22 issued and pending U.S. patents and patent
applications as well as their international counterparts. We believe
this portfolio will benefit our business by broadening our drug
delivery technology base and strengthening our intellectual property
position.
— Reduction in Convertible Notes. We reduced the balance of our
outstanding convertible notes from $37.3 million at December 31, 2006
to $23.6 million as of December 31, 2007 by paying a small premium over
the future interest payments due on these notes in order to induce
early conversion. The outstanding convertible notes will mature on
June 15, 2008, if not converted earlier.
Financial Guidance for 2008 and Major Potential Milestones Over the Next
12-18 Months
— 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 2008 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 2008 will be approximately
$32-36 million.
— Business Development Activities. We have multiple late stage programs
that may potentially be partnered over the next 12-18 months. These
include ELADUR, TRANSDUR-Sufentanil for Europe and for Asia, POSIDUR
for Asia, as well as various internal programs which we have not
described publicly in detail.
— Remoxy. Our collaborator, Pain Therapeutics, has stated that they
expect to file the NDA for Remoxy in Q2 2008.
— POSIDUR. We are continuing our dialogue with the FDA regarding our
Phase III program, upon completion of which we plan to commence that
program.
— ELADUR. We are conducting manufacturing scale-up and processing to
secure Phase III supplies, and are developing our clinical and
regulatory strategy.
— TRANSDUR-Sufentanil Patch. Endo Pharmaceuticals is continuing to
conduct Phase II studies with TRANSDUR-Sufentanil designed to evaluate
the conversion of patients on oral opioids to TRANSDUR-Sufentanil.
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
http://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 the anticipated filing of
an NDA for Remoxy, our anticipated commencement of the Phase III program for
POSIDUR, our possible entry into future collaborative agreements and our
projected financial results as well as other statements regarding DURECT’s
products in development, product development plans, anticipated regulatory,
clinical and development milestones and timing thereof, future clinical trial
results, our business development intentions 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 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 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-Q on November 8, 2007 under the 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,
2007 2006 2007 2006
Collaborative research and
development revenue $4,559 $3,522 $14,417 $13,786
Milestone revenue - - 8,000 -
Product revenue, net 2,026 1,919 8,258 8,108
Total revenues 6,585 5,441 30,675 21,894
Operating expenses:
Cost of revenues (1) 807 983 3,225 3,248
Research and development (1) 9,502 11,598 38,342 37,241
Selling, general and
administrative (1) 3,262 2,877 13,618 12,417
Amortization of intangible
assets 8 8 31 424
Total operating expenses 13,579 15,466 55,216 53,330
Loss from operations (6,994) (10,025) (24,541) (31,436)
Other income (expense):
Interest and other income 753 991 3,545 3,832
Interest expense (475) (717) (2,625) (3,436)
Debt conversion expense (495) - (718) (2,287)
Net other income (expense) (217) 274 202 (1,891)
Net loss $(7,211) $(9,751) $(24,339) $(33,327)
Net loss per share, basic and
diluted $(0.10) $(0.14) $(0.35) $(0.51)
Shares used in computing basic and
diluted net loss per share 73,641 68,980 70,483 65,961
(1) Includes stock-based
compensation related to the
following:
Cost of revenues $32 $28 $130 $75
Research and development 995 801 4,286 2,885
Selling, general and administrative 553 420 2,273 1,431
Total stock-based compensation $1,580 $1,249 $6,689 $4,391
DURECT CORPORATION
Condensed Balance Sheet
(in thousands)
As of As of
December 31, December 31,
2007 2006 (1)
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $37,589 $41,554
Short-term investments 19,710 28,297
Accounts receivable 3,622 2,152
Inventories 1,963 2,052
Prepaid expenses and other current assets 1,904 1,744
Total current assets 64,788 75,799
Property and equipment, net 7,658 7,451
Goodwill 6,399 6,399
Intangible assets, net 180 111
Long-term investments 3,697 10,472
Restricted Investments 1,020 1,284
Other non-current assets 278 969
Total assets $84,020 $102,485
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $1,834 $864
Accrued liabilities 5,499 4,522
Contract research liability 1,946 1,624
Interest payable on convertible notes 61 97
Deferred revenue, current portion 5,728 5,348
Equipment financing obligations, current portion 38 34
Bonds payable, current portion 225 210
Convertible subordinated notes due 2008 23,599 -
Other short-term liabilities 158 -
Total current liabilities 39,088 12,699
Bond payable and equipment financing obligations,
noncurrent portion 343 606
Convertible subordinated notes due 2008 - 37,337
Deferred revenue, noncurrent portion 9,268 14,507
Other long-term liabilities 740 304
Stockholders' equity 34,581 37,032
Total liabilities and stockholders' equity $84,020 $102,485
(1) Derived from audited financial statements.
SOURCE DURECT Corporation
02/05/2008
CONTACT: Matt Hogan, Chief Financial Officer of DURECT Corporation,
+1-408-777-4936
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