DURECT CORPORATION CUPERTINO, Calif., May 5, 2016 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the first quarter of 2016. Total revenues were $3.6 million and net loss was $7.9 million for the three months ended March 31, 2016 as compared to total revenues of $4.8 million and net loss of $4.9 million for the three months ended March 31, 2015.
At March 31, 2016, we had cash and investments of $24.3 million, compared to cash and investments of $29.3 million at December 31, 2015. Subsequent to the end of the first quarter, we raised net proceeds of approximately $17.0 million from the sale of additional shares of common stock. Including these proceeds, our pro forma cash and investments at March 31, 2016 would have been approximately $41.3 million. At March 31, 2016, we had $19.7 million in short and long term debt.
"The highlight of the quarter was undoubtedly the resubmission of the REMOXY(®) NDA, followed by its acceptance for review by the FDA and the establishment of a September 25, 2016 PDUFA date," stated James E. Brown, D.V.M., President and CEO of DURECT. "With respect to DUR-928, we have progressed into our first two patient studies with results anticipated during the course of this year. For POSIMIR(®), we continued the PERSIST Phase 3 trial which we are in the process of amending in response to an FDA recommendation."
Update of Selected Programs:·
-- Epigenomic Regulator Program. DUR-928, our Epigenomic Regulator
Program's lead product candidate, is an endogenous, small molecule, new
chemical entity (NCE), which may have broad applicability in several
metabolic diseases such as nonalcoholic fatty liver disease (NAFLD) and
nonalcoholic steatohepatitis (NASH), and in acute organ injuries such as
acute kidney injury. During the first quarter, we began our first
patient trial utilizing DUR-928. This study is an open-label
single-ascending-dose safety and pharmacokinetic Phase 1b trial of
DUR-928 in NASH patients and matched control subjects. This study will
be conducted in successive cohorts evaluating single-dose levels of oral
DUR-928. After a PK/safety review at each dose, the study can proceed to
the next higher dose. The study is being conducted in Australia, and we
anticipate that we will start obtaining results from this trial in the
second quarter of 2016. This study is designed to enable and inform a
subsequent multi-dose study in NASH or other patients with other liver
function impairment.In addition, our protocol has been approved by the
institutional review board for a second study in patients with DUR-928,
also being conducted in Australia. This Phase 1b trial of DUR-928 is an
open-label single-ascending-dose safety and pharmacokinetic study in
patients with impaired kidney function and matched control subjects.
This study will be conducted in successive cohorts evaluating
single-dose levels of DUR-928 administered by injection. After a
PK/safety review at each dose, the study can proceed to the next higher
dose. We anticipate that this study will be completed in 2016, and that
this study will enable and inform subsequent trials for patients with
either acute kidney injury or other kidney function impairment.
-- REMOXY (oxycodone) Extended-Release Capsules CII. Based on our ORADUR
technology, REMOXY is a unique long-acting formulation of oxycodone
designed to discourage common methods of tampering associated with
opioid misuse and abuse. Pain Therapeutics (our licensee) resubmitted
the NDA on schedule in March 2016. In April 2016, Pain Therapeutics
announced that the FDA had determined that the NDA was sufficiently
complete to permit a substantive review and that September 25, 2016 is
the target action date under the Prescription Drug User Fee Act (PDUFA).
The extended release oxycodone market is greater than $2 billion in the
U.S. alone, and we are eligible for a potential royalty on REMOXY
between 6.0% to 11.5% of net sales depending on sales volumes.
-- POSIMIR (SABER(®)-Bupivacaine) Post-Operative Pain Relief Depot. In
November 2015, we began enrolling patients for PERSIST, a new POSIMIR
Phase 3 clinical trial, consisting of patients undergoing laparoscopic
cholecystectomy (gallbladder removal) surgery. In a previous clinical
trial of 50 patients undergoing laparoscopic cholecystectomy, POSIMIR
was compared with the active control bupivacaine hydrochloride, against
which POSIMIR demonstrated in a post hoc analysis an approximately 25%
reduction in pain intensity on movement for the first 3 days after
surgery (p=0.024), using the same statistical methodology specified for
the current trial. We began recruiting patients for this trial with an
intent to compare POSIMIR to placebo. Based on recommendations from the
FDA received subsequent to the start of the trial, in April 2016 we
decided to amend the PERSIST trial including by incorporating standard
bupivacaine HCl as an active control. This change will add to the time
and cost to complete the PERSIST trial, but we believe that a positive
outcome from this trial design would result in a stronger NDA filing and
potentially commercial advantages. This clinical trial is designed to
generate data necessary to support an NDA resubmission.POSIMIR is our
investigational post-operative pain relief depot that utilizes our
patented SABER technology and is intended to deliver bupivacaine to
provide 3 days of pain relief after surgery. We are in discussions with
potential partners regarding licensing development and commercialization
rights to POSIMIR, for which we hold worldwide rights. We are also
continuing to evaluate the requirements for commercializing POSIMIR on
our own in the U.S., in the event that we determine that to be the
preferred route of commercialization.
-- Relday (Risperidone Program). Relday is a proprietary, long-acting,
once-monthly subcutaneous injectable formulation of risperidone for the
treatment of schizophrenia. In September 2015, Zogenix (our licensee)
announced that they had completed a multi-dose Phase 1b trial with
results consistent with the profile of risperidone and a previous Phase
1 single-dose clinical trial. Zogenix has stated that it is seeking a
development and commercialization partner for Relday and that Relday is
well-positioned to begin a Phase 3 program once a partner is secured.
-- ORADUR-ADHD Program. In 2013, we selected a formulation for the lead
program in our ORADUR-ADHD (Attention Deficit Hyperactivity Disorder)
program, ORADUR-Methylphenidate. This formulation was chosen based on
its potential for rapid onset of action, long duration with once-a-day
dosing and target pharmacokinetic profile as demonstrated in a Phase 1
trial. In addition, this product candidate utilizes a small capsule size
relative to the leading existing long acting products on the market and
incorporates our ORADUR anti-tampering technology. Orient Pharma, our
licensee in defined Asian and South Pacific countries, has initiated a
Phase 3 study in Taiwan and anticipates completing it in 2016. We retain
rights to all other markets in the world, notably including the U.S.,
Europe and Japan, and are engaged in licensing discussions with other
companies.
-- Business Development Activities. We have multiple programs that may
potentially be licensed over the next 12-18 months. These include
POSIMIR, DUR-928, 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 first quarter 2016 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on May 5 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 biopharmaceutical company actively developing new therapeutics based on its Epigenomic Regulator Program and proprietary drug delivery platforms. DUR-928, a new chemical entity in Phase 1 development, is the lead candidate in DURECT's Epigenomic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 plays an important regulatory role in lipid homeostasis, inflammation, and cell survival, and may have applications related to acute organ injury and chronic metabolic disease, notably nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). DURECT's advanced oral, injectable, and transdermal delivery technologies enable new indications and enhanced attributes, such as abuse deterrence, extended dosing intervals, and superior safety and efficacy, for small-molecule and biologic drugs. Late-stage development programs in this category include POSIMIR(®) and REMOXY(®), addressing key unmet needs in pain management. For more information, please visit www.durect.com.
NOTE: POSIMIR(®), SABER(®), and ORADUR(®) are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. REMOXY, POSIMIR, DUR-928, ORADUR-Methylphenidate 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 regulatory matters, including the PDUFA date for REMOXY and potential FDA approval of REMOXY and our other product candidates, ongoing clinical trials (including timing and results) for POSIMIR, DUR-928, ORADUR-Methylphenidate and our other drug candidates, potential royalties from Pain Therapeutics, the potential license of POSIMIR, DUR-928, ORADUR-ADHD and other products, the potential benefits and uses of our drug candidates, potential markets for our product candidates, potential plans to commercialize POSIMIR ourselves, collaborations with third parties, including Pain Therapeutics' plans for REMOXY and Zogenix's plans for Relday, and other 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 the FDA will not approve REMOXY or will delay doing so, the risk that the clinical trial of POSIMIR will take longer to conduct than anticipated or result in data that will not support a successful NDA resubmission or product approval, the risk that prior clinical trials (including prior trials of POSIMIR in laparoscopy patients) will not be confirmed in subsequent trials, the potential failure of clinical trials to meet their intended endpoints, the risk that Pain Therapeutics, Zogenix or Orient Pharma will discontinue development of REMOXY, Relday or ORADUR-Methylphenidate, respectively, or be delayed in development or regulatory submissions, the risk of adverse decisions by regulatory agencies, including requests for additional information or product non-approval or non-acceptance of our potential POSIMIR NDA submission, delays and additional costs due to requirements imposed by regulatory agencies, additional time and resources that may be required for development, testing and regulatory approval of DUR-928, potential adverse effects arising from the testing or use of our drug candidates, 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-K filed on March 1, 2016 under the heading "Risk Factors."
DURECT CORPORATION
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands, except per share amounts)
(unaudited)
Three months ended
March 31
--------
2016 2015
---- ----
Collaborative
research and
development
and other
revenue $419 $1,738
Product
revenue, net 3,189 3,035
Total revenues 3,608 4,773
-----------
Operating expenses:
Cost of
product
revenues 1,242 1,006
Research and
development 6,625 5,367
Selling,
general and
administrative 3,062 2,820
Total
operating
expenses 10,929 9,193
------ -----
Loss from
operations (7,321) (4,420)
Other income (expense):
Interest and
other income 27 128
Interest
expense (558) (561)
---------
Net other
income
(expense) (531) (433)
Net loss $(7,852) $(4,853)
======= =======
Net loss per share
Basic $(0.06) $(0.04)
Diluted $(0.06) $(0.04)
Weighted-average shares used in
computing net loss per share
Basic 122,149 113,793
Diluted 122,149 113,793
Total
comprehensive
loss $(7,835) $(4,938)
======= =======
DURECT CORPORATION
CONDENSED BALANCE SHEETS
(in thousands)
As of As of
March 31, 2016 December 31, 2015(1)
-------------- -------------------
(unaudited)
ASSETS
Current assets:
Cash and cash
equivalents $3,853 $3,583
Short-term
investments 20,181 25,457
Short-term
restricted
Investments 100 -
Accounts
receivable 1,722 2,222
Inventories 4,007 3,917
Prepaid expenses
and other current
assets 3,074 3,142
----- -----
Total current
assets 32,937 38,321
Property and
equipment, net 1,477 1,566
Goodwill 6,399 6,399
Long-term
restricted
Investments 150 250
Other long-term
assets 236 236
Total assets $41,199 $46,772
======= =======
LIABILITIES AND
STOCKHOLDERS'
EQUITY
Current
liabilities:
Accounts payable $994 $1,286
Accrued
liabilities 4,552 4,970
Contract research
liability 454 575
Deferred revenue,
current portion 464 616
Current portion of
Long-term debt,
net 1,826 -
----- ---
Total current
liabilities 8,290 7,447
Deferred revenue,
noncurrent
portion 2,206 2,269
Long-term debt,
net 17,892 19,684
Other long-term
liabilities 2,585 2,489
Stockholders'
equity 10,226 14,883
Total liabilities
and stockholders'
equity $41,199 $46,772
======= =======
(1) Derived from audited
financial statements.
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SOURCE DURECT Corporation
