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DURECT Corporation Announces Fourth Quarter 2012 Financial Results and Update of Programs
Submitted by admin on 2/28/2013 @ 1:05 PM
Companies mentioned in this article:
DURECT Corporation
CUPERTINO, Calif., Feb. 28, 2013 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended December 31, 2012. Total revenues were $3.3 million for the three months ended December 31, 2012 as compared to $8.9 million for the three months ended December 31, 2011. Net loss was $5.5 million for the three months ended December 31, 2012 as compared to a net loss of $2.1 million for the same period in 2011.
(Logo: http://photos.prnewswire.com/prnh/20020717/DRRXLOGO)
Total revenues were $53.1 million and net income was $16.2 million for the year ended December 31, 2012; these figures include the accelerated recognition in the first quarter of 2012 of $35.4 million in deferred revenue associated with upfront fees previously received under terminated collaboration agreements. This $35.4 million in revenue was non-recurring and had no cash flow impact for the year. Excluding the accelerated recognition of deferred revenue, DURECT's reported revenues would have been $17.7 million for the year ended December 31, 2012 (as compared to $25.9 million for the same period in 2011 excluding the recognition of deferred revenue associated with the agreements terminated in 2012) and reported net loss would have been $19.2 million for the year ended December 31, 2012 (as compared to a net loss of $26.3 million for the same period in 2011 excluding the recognition of deferred revenue associated with the agreements terminated in 2012).
At December 31, 2012, we had cash and investments of $28.9 million, compared to cash and investments of $30.8 million at December 31, 2011. We have no debt obligations, other than normal liabilities associated with running our business.
"We are in the final stages of preparing a new drug application for POSIDUR((TM)), which we expect to submit to the FDA near the end of the first quarter of 2013," stated James E. Brown, D.V.M., President and CEO of DURECT. "Communications with Pfizer indicate that they intend to meet with the FDA as planned in late March to discuss their proposed resubmission plan for REMOXY(®). We also are pleased that Zogenix recently reported positive Phase 1 clinical trial results for Relday((TM)) and has quickly extended that trial at a higher dose."
In 2013, we look forward to:
-- Pfizer conducting a meeting with the FDA to discuss the REMOXY
resubmission
-- Submitting the POSIDUR NDA near the end of Q1 2013
-- Supporting Zogenix as they extend a Phase I study with Relday
-- Selecting a formulation based on our Phase I studies to take forward in
our ORADUR(®)-ADHD program
-- Potentially entering into additional feasibility studies and
collaborations
-- Continuing to add to our patent portfolio
Highlights for DURECT in Fiscal Year 2012 and Major Potential Milestones over the Next 12-18 Months:
-- REMOXY (oxycodone) Extended-Release Capsules CII. Pfizer has efforts
underway to resolve the issues raised in the REMOXY Complete Response
Letter, which are primarily manufacturing. Pfizer is targeting a meeting
with the FDA in late March to discuss their proposed resubmission plan
for REMOXY. Based on feedback Pfizer receives from the FDA at the
meeting, Pfizer will subsequently determine the next steps and/or
required timing to respond to the Complete Response Letter. REMOXY,
an investigational drug, is a unique long acting oral formulation of
oxycodone intended to treat moderate-to-severe pain when a continuous,
around the clock opioid analgesic is needed for an extended period of
time. Based on DURECT's ORADUR technology, which is covered by issued
patents and pending patent applications owned by us, REMOXY is designed
to discourage common methods of tampering associated with prescription
opioid analgesic misuse and abuse.
-- POSIDUR( )(SABER(®)-Bupivacaine) Post-Operative Pain Relief Depot.
Following our pre-NDA communications during the summer of 2012 with the
FDA regarding POSIDUR, we intend to submit a new drug application (NDA)
under 505(b)(2) with the FDA near the end of the first quarter of
2013.POSIDUR is our investigational 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. We are in
discussions with potential partners regarding licensing development and
commercialization rights to POSIDUR, for which we hold worldwide rights.
-- Transdermal Development Candidates. DURECT has two transdermal
products that are in mid- to late-stage development with features that
may be superior to currently available patches. TRANSDUR(®)-Sufentanil
is our proprietary transdermal patch intended to deliver sufentanil to
chronic pain sufferers for a period of up to 7 days from a single
application; this compares favorably against existing fentanyl patches
which are substantially larger and typically effective for 2-3 days.
ELADUR(®), for topical neuropathic conditions such as post-herpetic
neuralgia (PHN), is our proprietary transdermal patch intended to
deliver bupivacaine for a period of up to three days from a single
application; existing lidocaine patches for this condition can be worn
for 12 hours with a rest period of 12 hours during which time many
patients experience breakthrough pain. We are in discussions with
potential partners regarding licensing development and commercialization
rights to these two transdermal programs for which we hold worldwide
rights.
-- ORADUR-ADHD Program. We are developing a drug candidate (ORADUR-ADHD)
based on DURECT's ORADUR Technology for the treatment of Attention
Deficit Hyperactivity Disorder. This drug candidate is intended to
provide once-a-day dosing with added tamper resistant characteristics to
address common methods of abuse and misuse of these types of drugs. We
and Orient Pharma have completed several Phase I pharmacokinetic studies
with multiple formulations, and we are continuing to optimize our lead
formulations. Orient Pharma is our licensee for certain Asian and South
Pacific countries, while we retain the rights to the rest of the world.
-- Relday (Risperidone Program). In July 2011, we signed a development and
license agreement with Zogenix to develop Relday, a product candidate
targeting the antipsychotic market. In January 2013, Zogenix announced
positive single-dose pharmacokinetic (PK) results from the Phase 1
clinical trial of Relday. According to Zogenix, adverse events in the
Phase 1 trial in patients diagnosed with schizophrenia were generally
mild to moderate and consistent with other risperidone products. The
Phase 1 clinical trial for Relday was conducted as a single-center,
open-label, safety and PK trial of 30 patients with chronic, stable
schizophrenia or schizoaffective disorder. Per Zogenix, based on the
favorable safety and PK profile demonstrated with the 25 mg and 50 mg
once-monthly doses tested in the Phase 1 trial, Zogenix has extended the
study to include a 100 mg dose of the same formulation. The addition of
this dose arm to the study will enable evaluation of dose
proportionality across the full dose range that would be anticipated to
be used in clinical practice. Zogenix expects to complete the extension
of the Phase 1 clinical trial during the second quarter of 2013.Relday
is a proprietary, long-acting (once-monthly) subcutaneous injectable
formulation of risperidone using DURECT's SABER controlled-release
formulation technology. An existing long-acting injectable risperidone
product, which achieved $1.4 billion in global net sales in 2012,
requires twice-monthly, intramuscular injections and drug reconstitution
prior to use.
-- Feasibility Projects and Other Activities. During the fourth quarter of
2012, we continued work on several feasibility projects and signed new
projects as a means of demonstrating that our technologies can achieve
the drug delivery objectives set forth by our collaborators and are
worthy of further development. The Zogenix program, described above,
was one such project which has matured into a development and license
agreement.
-- Patent Issuances. In 2012, we had multiple important patents issue in
the U.S. and other important commercial markets. In addition to these
issuances, we continue to file new applications protecting our
technologies and programs, and are pursuing existing applications which
may extend the patent life of several key programs. Reflecting key
issuances since January 1, 2012, our patent portfolio now includes:
-- REMOXY. In the U.S., REMOXY is now covered by four patent families.
Two patent families include granted patents expiring in at least
2015 and 2025, respectively. The later expiring of these two patent
families includes five granted patents. In Europe, REMOXY is
covered by two granted patents expiring in at least 2016 and 2023,
respectively.
-- POSIDUR. In the U.S., POSIDUR is now covered by two patent families,
which include granted patents expiring in at least 2015 and 2025,
respectively. In Europe, POSIDUR is covered by two granted patents
expiring in at least 2016 and 2025, respectively.
-- ELADUR. In the U.S., we received issuance of a patent expiring in
2031 and in Europe we also received issuance of a patent expiring in
at least 2027.
-- TRANSDUR-Sufentanil. In the U.S., we received issuance of three
patents with coverage until at least 2025 and in Europe, we also
received issuance of a patent with coverage until at least 2025.
-- Financial Guidance. Our net cash consumption is influenced by the
timing and structure of new corporate collaborations, the achievement of
milestones under existing collaborations, and the extent to which we
choose to fund unpartnered programs. While we anticipate entering into
new collaborations in the future, assuming current funding plans for our
R&D programs without funding from new collaborations or milestone
payments, we currently anticipate our net cash consumption in 2013 will
be approximately $14-16 million.
-- Business Development Activities. We have multiple programs that may
potentially be licensed over the next 12-18 months. These include
POSIDUR, TRANSDUR-Sufentanil, ELADUR, ORADUR-ADHD (territories outside
certain Asian and South Pacific markets), as well as various other
programs which we have not described publicly in detail.
Earnings Conference Call
A live audio webcast of a conference call to discuss fourth quarter 2012 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on February 28 and is available by accessing DURECT's homepage at 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 is a specialty pharmaceutical company developing innovative drugs for pain and chronic diseases, with late-stage development programs including REMOXY(®), POSIDUR((TM)), ELADUR(®), and TRANSDUR(®)-Sufentanil. DURECT's proprietary oral, transdermal 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 www.durect.com.
NOTE: POSIDUR((TM)), SABER(®), ORADUR(®), TRANSDUR(®) and ELADUR(®) are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. REMOXY, POSIDUR, ELADUR, TRANSDUR-Sufentanil and Relday are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding the potential regulatory meetings and submissions for REMOXY and POSIDUR, anticipated clinical trials (including timing and results) for Relday and our other drug candidates, projected cash consumption, the potential benefits and uses of our drug candidates, collaborations with third parties and potential business development activities 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, the risk that Pfizer will discontinue development of REMOXY, the risk of adverse decisions by regulatory agencies, including rejection of meeting requests, requests for additional information or product non-approval or non-acceptance of our POSIDUR or other NDA submissions, delays and additional costs due to requirements imposed by regulatory agencies, potential adverse effects arising from the testing or use of our drug candidates, the potential failure of our clinical trials to meet their intended endpoints, our potential failure to maintain our collaborative agreements with third parties or consummate new collaborations and risks related to our (and our third party collaborators where applicable) ability to design, enroll, conduct and complete clinical trials, complete the design, development, and manufacturing process development of product candidates, manufacture and commercialize product candidates, obtain marketplace acceptance of product candidates, avoid infringing patents held by other parties and secure and defend patents of our own, and manage and obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-Q on November 6, 2012 under the heading "Risk Factors."
DURECT CORPORATION
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(in thousands, except per share amounts)
(unaudited)
Three months ended Year ended
December 31, December 31,
------------ ------------
2012 2011 2012 2011(1)
---- ---- ---- ------
Collaborative research and
development and other revenue $813 $6,454 $42,494 $22,360
Product revenue, net 2,449 2,481 10,576 11,127
Total revenues 3,262 8,935 53,070 33,487
-----
Operating expenses:
Cost of product revenues 1,038 927 4,654 4,713
Research and development 4,904 7,013 20,265 34,053
Selling, general and administrative 2,911 3,154 12,095 13,574
Total operating expenses 8,853 11,094 37,014 52,340
----- ------ ------ ------
Income (loss) from operations (5,591) (2,159) 16,056 (18,853)
Other income (expense):
Interest and other income 95 25 151 134
Interest and other expense (2) (4) (7) (46)
---
Net other income 93 21 144 88
Net Income (loss) $(5,498) $(2,138) $16,200 $(18,765)
======= ======= ======= ========
Net income (loss) per share
Basic $(0.06) $(0.02) $0.18 $(0.21)
=====
Diluted $(0.06) $(0.02) $0.18 $(0.21)
=======
Weighted-average shares used in computing net income
(loss) per share
Basic 90,881 87,514 88,433 87,410
=====
Diluted 90,881 87,514 88,589 87,410
======
Total comprehensive income
(loss) $(5,498) $(2,144) $16,201 $(18,766)
======= ======= ======= ========
(1) Derived from audited financial statements.
DURECT CORPORATION
BALANCE SHEET DATA
(in thousands)
As of As of
December 31, 2012 December 31, 2011(1)
----------------- -------------------
(unaudited)
ASSETS
Current assets:
Cash and cash
equivalents $11,195 $8,896
Short-term
investments 17,337 19,535
Short-term
restricted
investments - 367
Accounts
receivable 2,166 3,448
Inventories 3,399 3,252
Prepaid expenses
and other
current assets 2,258 1,803
----- -----
Total current
assets 36,355 37,301
Property and
equipment, net 2,457 3,124
Goodwill 6,399 6,399
Intangible
assets, net 36 53
Long-term
investments - 1,530
Long-term
restricted
Investments 400 501
Other long-term
assets 288 288
Total assets $45,935 $49,196
======= =======
LIABILITIES AND
STOCKHOLDERS'
EQUITY
Current
liabilities:
Accounts payable $1,785 $1,274
Accrued
liabilities 3,997 4,884
Contract research
liability 483 1,361
Deferred revenue,
current portion 662 7,372
--- -----
Total current
liabilities 6,927 14,891
Deferred revenue,
noncurrent
portion 1,480 30,090
Other long-term
liabilities 1,197 738
Stockholders'
equity 36,331 3,477
Total liabilities
and
stockholders'
equity $45,935 $49,196
======= =======
(1) Derived from
audited
financial
statements.
SOURCE DURECT Corporation