CUPERTINO, Calif., Nov. 7, 2018 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced financial results for
the three months ended September 30,
2018 and provided a corporate update.
- Total revenues were $8.0 million
and net loss was $2.7 million for the
three months ended September 30, 2018
as compared to total revenues of $20.7
million and net income of $6.1
million for the three months ended September 30, 2017. The third quarter of 2018
included a $5 million milestone
payment from Indivior related to the FDA approval of
PERSERIS™ (risperidone). The third quarter of 2017
included $12.5 million in revenues
from the upfront payment related to a patent purchase agreement
with Indivior.
- At September 30, 2018, cash and
investments were $41.5 million,
compared to cash and investments of $36.9
million at December 31, 2017.
Debt at September 30, 2018 was
$19.9 million.
"During the third quarter, we benefited from two product
approvals through corporate relationships, most notably U.S. FDA
approval of Indivior's PERSERIS to treat adults with schizophrenia,
as well as the Taiwan Ministry of Health and Welfare's approval of
Orient Pharma's Methydur Sustained Release Capsules to treat
patients with ADHD," stated James E.
Brown, D.V.M., President and CEO of DURECT. "We expect
anticipated earn-outs and royalties from these approvals to begin
providing cash flow, starting next year, that will help finance the
development of our proprietary pipeline, including DUR-928, which
we are currently evaluating in two Phase 2a clinical trials in
alcoholic hepatitis (AH) and primary sclerosing cholangitis (PSC).
We are planning to accelerate enrollment in the AH trial by
enrolling both moderate and severe AH patients simultaneously going
forward. In addition, we plan to initiate a Phase 2a clinical trial
of topical DUR-928 in patients suffering from psoriasis in the
first quarter of 2019, and a trial in nonalcoholic steatohepatitis
(NASH) patients in the first half of 2019."
Update on Selected Programs:
Epigenetic Regulator Program. DUR-928, the lead
product candidate in the Company's Epigenetic Regulator Program, is
an endogenous, first-in-class small molecule, which may have broad
applicability in several hepatic and renal diseases such as NASH
and PSC, in acute organ injuries such as AH and acute kidney injury
(AKI), and in inflammatory skin disorders such as psoriasis and
atopic dermatitis.
Ongoing Clinical Trials
Alcoholic Hepatitis (AH)
- DURECT is conducting a Phase 2a clinical trial with
intravenously administered DUR-928 in patients with AH. This is an
open label, dose escalation, multi-center U.S. study, originally
designed to be conducted in two sequential parts. Part A includes
patients with moderate AH (as determined by the Model of End-Stage
Liver Disease (MELD) scores, a common scoring system to assess the
severity and prognosis of AH patients), and Part B includes
patients with severe AH. Three dose levels (30, 90 and 150 mg) are
planned for testing in Part A. Dose escalation occurs following
review of safety and pharmacokinetic (PK) results of the prior dose
level by a Dose Escalation Committee (DEC). The target number of
patients for the study is 4-6 per dose group. The objectives of
this study include safety, PK and pharmacodynamic (PD) signals,
including liver biochemistry and biomarkers. Additional information
on the trial design, including eligibility criteria and site
locations, can be found at www.clinicaltrials.gov using the NCT
Identifier NCT03432260.
- The Company recently completed dosing for the low-dose 30 mg
cohort (n=4) of Part A (moderate AH patients). After completing the
safety and PK review by the DEC, DURECT plans to commence the 90 mg
cohort in Part A.
- The Company has amended the protocol so that after the DEC
completes its review, DURECT can begin enrolling Part B (severe AH
patients), starting with the low dose, while it simultaneously
continues enrolling Part A (moderate AH patients). The Company
believes enrolling Part A and B simultaneously will accelerate the
overall timeline for the trial. Over the course of the trial, the
clinical sites have encountered many severe AH patients who may
have qualified for Part B but were deemed screen failures due to
their MELD scores being too high for Part A.
- AH is a syndrome of progressive inflammatory liver injury
associated with long-term heavy intake of alcohol, and encompasses
a spectrum that ranges from mild injury to severe, life threatening
liver damage. The prevalence of AH is estimated to occur in 10-35%
of heavy drinkers. According to an article in the Journal of
Clinical Gastroenterology (2015 July; 49(6): 506-511), there were
over 320,000 hospitalizations related to alcoholic hepatitis in
2010, resulting in hospitalization costs of nearly $50,000 per patient.
Primary Sclerosing Cholangitis (PSC)
- The Company is currently conducting a Phase 2a clinical trial
in PSC with orally administered DUR-928. This is a randomized, open
label, multi-center study with two cohorts (10 mg and 50 mg), in
which patients (n = 15-20 per cohort) receive daily oral dosing of
DUR-928 for four weeks with follow-up for an additional four weeks.
The objectives of this study include safety, PK and PD signals,
including the percent change from baseline of serum alkaline
phosphatase (ALP) and other biomarkers. Additional information on
the trial design, including eligibility criteria and site
locations, can be found at www.clinicaltrials.gov using the NCT
Identifier NCT03394781. To date, five PSC patients have been dosed,
and as such the Company is not able to provide meaningful interim
data at this time. The Company plans to continue enrolling patients
and will provide an update when enrollment has reached a critical
mass for data analysis.
- PSC is a chronic liver disease characterized by a progression
of cholestasis (decrease in bile flow) with inflammation and
fibrosis of bile ducts. DUR-928 has been awarded orphan drug
designation for the PSC indication.
Planned Clinical Trials
Psoriasis
- The Company is planning to conduct a Phase 2a proof-of-concept
trial with topical DUR-928 in patients with mild to moderate plaque
psoriasis beginning in the first quarter of 2019. This will be a
multicenter, randomized, double-blind, vehicle-controlled clinical
trial conducted in the U.S. Approximately 20 subjects will be
enrolled to obtain about 15 evaluable subjects in the study.
DUR-928 will be applied topically once-daily for four weeks.
Patients will serve as their own controls, as each patient will
have similar contralateral plaques. DUR-928 will be applied to one
plaque and the vehicle control will be applied to the contralateral
plaque daily for four weeks. Patients will be followed for an
additional four weeks and the primary efficacy endpoint will be
improvement in local psoriasis scores in the DUR-928-treated plaque
compared to the vehicle-treated plaque.
- The Company observed activity of DUR-928 in a previous
exploratory Phase 1b trial utilizing
intralesional injections of DUR-928 in psoriasis patients. In
support of the upcoming study, it has completed multiple
non-clinical safety studies for topically applied DUR-928.
- Skin inflammatory disorders, such as psoriasis and atopic
dermatitis, affect approximately 7.5 million and 32 million
Americans, respectively. Most currently available topical
treatments, typically as first line therapy, either slow down
excessive skin cell proliferation or reduce inflammation. Steroids
are the most commonly used topical anti-inflammatory agents because
they reduce the swelling and redness of lesions.
Non-Alcoholic Steatohepatitis (NASH)
- DURECT is planning to conduct a clinical trial in NASH patients
with orally-administered DUR-928 beginning in the first half of
2019. Further details on study design and timing will be
provided as the Company gets closer to initiation. In the
Company's previous Phase 1b NASH
study, reported at the European Association for the Study of the
Liver (EASL) in April 2017, a
reduction of certain biomarkers after a single oral dose of DUR-928
was observed. Exploratory biomarker analysis indicated that a
single oral dose of DUR-928 in NASH patients resulted in
statistically significant reductions from baseline of both
full-length and cleaved cytokeratin-18 (CK-18), bilirubin, hsCRP
and IL-18.
Indivior Agreement and PERSERIS. In September 2017, the Company entered into a patent
purchase agreement with an affiliate of Indivior PLC, whereby the
Company assigned certain of its U.S. patent rights to Indivior.
This assignment may provide further intellectual property
protection for PERSERIS (risperidone) extended-release injectable
suspension for the treatment of schizophrenia in
adults.
Under the terms of the agreement, Indivior made an upfront
non-refundable payment to the Company of $12.5 million. Indivior also agreed to make
an additional $5 million payment to
the Company based on NDA approval of PERSERIS, as well as quarterly
earn-out payments that are based on a single digit percentage of
U.S. net sales for certain products covered by the patent rights,
including PERSERIS. The patent rights include granted patents
extending through at least 2026. In July 2018, the FDA approved the NDA for PERSERIS
and the Company received the $5
million milestone payment in August
2018. On November 1, 2018,
Indivior stated that they are preparing a full promotional launch
of PERSERIS with a field force of 40 to 60 representatives,
contingent upon the preliminary injunction against Dr. Reddy's
Laboratories being upheld by the U.S. Court of Appeals for the
Federal Circuit. Indivior further stated that they will be
making PERSERIS available in the U.S. in Q4 2018 to begin
generating product awareness and trial. For more information
on PERSERIS, please see Indivior's earnings press release dated
November 1, 2018. U.S. sales of
long acting injectables to treat schizophrenia were in excess of
$3 billion in 2017.
POSIMIR® (SABER®-Bupivacaine)
Post-Operative Pain Relief Depot. POSIMIR is the
Company's investigational post-operative pain relief depot that
utilizes the Company's patented SABER technology and is designed to
deliver bupivacaine to provide up to 3 days of pain relief after
surgery.
In October 2017, the Company
reported that PERSIST, a Phase 3 clinical trial for POSIMIR did not
meet its primary efficacy endpoint of reduction in pain on movement
as compared to standard bupivacaine HCl over the first 48 hours
after surgery. While the efficacy results trended in favor of
POSIMIR versus the comparator, they did not achieve statistical
significance. In May 2018, the
Company amended its U.S. licensing agreement with Sandoz, pursuant
to which DURECT is now eligible for up to $30 million in milestone payments based on NDA
approval, and remains eligible for up to an additional $230 million in sales-based milestones.
Each party, pursuant to the Amendment, is also permitted to develop
or commercialize competing products. The Amendment also
includes modifications to DURECT's development obligations and to
both parties' termination provisions, including a right for DURECT
to terminate for convenience prior to NDA approval. There is also a
new termination fee payable to DURECT in the event that Sandoz
terminates the agreement for convenience. The agreement
between the two companies remains in full force and effect, except
as expressly covered in the Amendment. DURECT continues to
evaluate and consider potential next steps with the program.
Methydur Sustained Release Capsules
(ORADUR®-methylphenidate ER Capsules). In
September 2018, Orient Pharma
informed DURECT that it had obtained marketing authorization from
the Ministry of Health and Welfare in Taiwan for Methydur Sustained Release
Capsules. This product is indicated for the treatment of
attention deficit hyperactivity disorder (ADHD) and will be
available in three strengths (22 mg, 33 mg and 44 mg) in
Taiwan. Orient Pharma also
has stated that it expects to make Methydur Sustained Release
Capsules commercially available in Taiwan in 2019, while seeking a partner in
China and pursuing regulatory
approvals in selected other countries where it has
commercialization rights and a commercial presence.
In August 2009, DURECT entered
into a development and license agreement with Orient Pharma Co.,
Ltd., a diversified multinational pharmaceutical, healthcare and
consumer products company with headquarters in Taiwan. In
this agreement, DURECT granted to Orient Pharma the development and
commercialization rights to ORADUR-Methylphenidate ER Capsules
(Methydur Sustained Released Capsules) in certain defined Asian and
South Pacific countries. DURECT retains rights to North America, Europe, Japan
and all other countries not specifically licensed to Orient
Pharma. DURECT is entitled to receive a royalty on sales of
Methydur Sustained Release Capsules by Orient Pharma. Orient Pharma
has also committed to supply a portion of the commercial
requirements in territories other than the United States for Methydur Sustained
Release Capsules.
Debt amendment. In November
2018, the Company amended its existing $20 million term loan with Oxford Finance such
that principal payments now commence 18 months later than
previously scheduled (i.e., commencing June
1, 2020 rather than December 1,
2018) and the final maturity date is moved back by 30 months
(i.e., from August 1, 2020 to
November 1, 2022). The interest
rate and final payment remain unchanged, and the Company paid
Oxford Finance an amendment fee of $900,000.
Upcoming investor conference. DURECT will be
presenting at the Stifel 2018 Healthcare Conference at 11:45 am Eastern time on Wednesday, November
14. The conference is being held at the Lotte New York Palace
Hotel. A live audio webcast of the presentation will be
available by accessing
http://wsw.com/webcast/stifel14/drrx . A live audio
webcast of these presentations will also be 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.
Earnings Conference Call
A live audio webcast
of a conference call to discuss third quarter 2018 results and
provide a corporate update will be broadcast live over the internet
at 4:30 p.m. Eastern Time on
November 7 and will be available by
accessing DURECT's homepage at www.durect.com and clicking
"Investor Relations." If you are unable to participate in 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
therapeutics based on its Epigenetic Regulator Program and
proprietary drug delivery platforms. DUR‑928, a new chemical
entity in Phase 2 development, is the lead candidate in DURECT's
Epigenetic Regulator Program. An endogenous, orally
bioavailable small molecule, DUR-928 has been shown in preclinical
studies to play an important regulatory role in lipid homeostasis,
inflammation, and cell survival. Human applications may
include acute organ injury such as Alcoholic Hepatitis (AH),
hepatic and renal diseases such as nonalcoholic steatohepatitis
(NASH) and Primary Sclerosing Cholangitis (PSC), and inflammatory
skin conditions such as psoriasis and atopic dermatitis.
DURECT's advanced oral and injectable delivery technologies are
designed to enable new indications and enhanced attributes for
small-molecule and biologic drugs. Late stage product
candidates in this category include POSIMIR® (Extended
Release Bupivacaine), an investigational locally-acting, non-opioid
analgesic intended to provide up to 3 days of continuous pain
relief after surgery, and ORADUR®-Methylphenidate ER
Capsules, approved in Taiwan as
Methydur Sustained Release Capsules, where it is indicated for the
treatment of attention deficit hyperactivity disorder (ADHD).
In addition, for the assignment of certain patent rights,
DURECT will receive single digit sales-based earn-out payments from
U.S. net sales of Indivior's PERSERIS™ (risperidone)
drug for schizophrenia, which was approved in July 2018. For
more information, please visit www.durect.com.
NOTE: ORADUR®, POSIMIR® and
SABER® are trademarks of DURECT Corporation.
Other referenced trademarks belong to their respective owners.
DUR-928 and POSIMIR 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 clinical
development plans for DUR-928, including potential acceleration of
the Phase 2a trial in AH, the initiation of a Phase 2a trial in
psoriasis, plans for a clinical trial in patients with NASH, and
the disclosure of data from the Phase 2a trial in PSC, potential
future payments from Indivior, Orient Pharma and Sandoz, and the
potential benefits and uses of our drug candidates, including the
potential use of DUR-928 to treat PSC, AH, other disorders of the
liver, kidney diseases, acute organ injuries, psoriasis, atopic
dermatitis or other inflammatory conditions, and our plans for
POSIMIR 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 risks that
future clinical trials of DUR-928 are not started when anticipated,
take longer to conduct than anticipated, or do not demonstrate the
safety or efficacy of DUR-928 in a statistically significant
manner, the risk that Indivior will not launch PERSERIS or
that it will obtain marketplace acceptance, the risk that Orient
Pharma will not launch sales of Methydur Sustained Release Capsules
as planned, the risk that Sandoz may terminate our agreement with
them and discontinue plans to commercialize POSIMIR, the risk that
prior clinical trials (including prior Phase 1b trials of DUR-928) will not be confirmed in
subsequent trials, the potential failure of clinical trials to meet
their intended endpoints, the risk that additional time and
resources that may be required for development, testing and
regulatory approval of DUR-928 or POSIMIR, 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 ability to obtain capital to fund operations and expenses.
Further information regarding these and other risks is included in
DURECT's Form 10-Q filed on August 2,
2018 under the heading "Risk Factors."
DURECT
CORPORATION
|
CONDENSED
STATEMENTS OF COMPREHENSIVE LOSS
|
(in thousands,
except per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Nine months
ended
|
|
|
|
September
30
|
|
September
30
|
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
|
|
Collaborative
research and development and other revenue
|
$
5,691
|
|
$
5,602
|
|
$
7,432
|
|
$
7,304
|
Product revenue,
net
|
2,345
|
|
2,644
|
|
7,505
|
|
9,828
|
Revenue from sale of
intellectual property rights
|
-
|
|
12,500
|
|
-
|
|
12,500
|
|
Total
revenues
|
8,036
|
|
20,746
|
|
14,937
|
|
29,632
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
revenues
|
912
|
|
3,105
|
|
3,170
|
|
5,572
|
|
Research and
development
|
6,542
|
|
8,378
|
|
19,614
|
|
25,005
|
|
Selling, general and
administrative
|
2,870
|
|
3,138
|
|
8,880
|
|
9,862
|
Total operating
expenses
|
10,324
|
|
14,621
|
|
31,664
|
|
40,439
|
|
|
|
|
|
|
|
|
|
|
Income (Loss) from
operations
|
(2,288)
|
|
6,125
|
|
(16,727)
|
|
(10,807)
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest and other
income
|
234
|
|
605
|
|
632
|
|
680
|
|
Interest and other
expense
|
(661)
|
|
(619)
|
|
(1,928)
|
|
(1,803)
|
Net other
expense
|
(427)
|
|
(14)
|
|
(1,296)
|
|
(1,123)
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss)
|
$ (2,715)
|
|
$
6,111
|
|
$(18,023)
|
|
$(11,930)
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share
|
|
|
|
|
|
|
|
|
Basic
|
|
$
(0.02)
|
|
$
0.04
|
|
$
(0.11)
|
|
$
(0.08)
|
|
Diluted
|
|
$
(0.02)
|
|
$
0.04
|
|
$
(0.11)
|
|
$
(0.08)
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net income (loss) per share
|
|
|
|
|
|
|
|
|
Basic
|
|
162,002
|
|
147,213
|
|
159,091
|
|
143,873
|
|
Diluted
|
|
162,002
|
|
151,885
|
|
159,091
|
|
143,873
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
income (loss)
|
$ (2,715)
|
|
$
6,114
|
|
$(18,022)
|
|
$(11,927)
|
DURECT
CORPORATION
|
CONDENSED BALANCE
SHEETS
|
(in
thousands)
|
|
|
|
|
|
|
|
As of
|
|
As of
|
|
|
September 30,
2018
|
|
December 31,
2017(1)
|
|
|
(unaudited)
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash equivalents
|
|
$
38,217
|
|
$
29,375
|
Short-term investments
|
|
3,090
|
|
7,384
|
Accounts receivable
|
|
1,606
|
|
2,376
|
Inventories, net
|
|
3,485
|
|
3,163
|
Prepaid expenses and other current assets
|
|
2,870
|
|
3,060
|
Total current
assets
|
|
49,268
|
|
45,358
|
|
|
|
|
|
Property and
equipment, net
|
|
677
|
|
929
|
Goodwill
|
|
6,399
|
|
6,399
|
Long-term restricted
Investments
|
|
150
|
|
150
|
Other long-term
assets
|
|
366
|
|
277
|
Total
assets
|
|
$
56,860
|
|
$
53,113
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable
|
|
$
1,152
|
|
$
1,520
|
Accrued liabilities
|
|
5,200
|
|
5,511
|
Contract research liability
|
|
1,375
|
|
834
|
Deferred revenue, current portion
|
|
13
|
|
682
|
Term loan, current portion, net
|
|
10,390
|
|
7,281
|
Total current
liabilities
|
|
18,130
|
|
15,828
|
|
|
|
|
|
Deferred revenue,
noncurrent portion
|
|
812
|
|
1,093
|
Term loan, noncurrent
portion, net
|
|
9,500
|
|
12,634
|
Other long-term
liabilities
|
|
2,324
|
|
2,070
|
|
|
|
|
|
Stockholders'
equity
|
|
26,094
|
|
21,488
|
Total liabilities and
stockholders' equity
|
|
$
56,860
|
|
$
53,113
|
|
|
|
|
|
|
(1) Derived
from audited financial statements.
|
View original
content:http://www.prnewswire.com/news-releases/durect-corporation-announces-third-quarter-2018-financial-results-and-provides-corporate-update-300745947.html
SOURCE DURECT Corporation