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PRNewswire 7-Mar-2019 4:05 PM
CUPERTINO, Calif., March 7, 2019 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced financial results for the three months and year ended December 31, 2018 and provided a corporate update.
"Based on encouraging data from both of the completed moderate and severe alcoholic hepatitis (AH) 30 mg cohorts, the relatively rapid enrollment of severe AH patients, and strong encouragement from several of our key expert advisors and clinical trial investigators, we have decided to continue our AH trial by conducting the next cohort of severe AH patients at the 90 mg dose. In parallel, we are continuing to recruit patients in the moderate AH 90 mg cohort and work with Dr. McClain at the University of Louisville on enabling initiation of his NIH-funded DUR-928 AH trial. We also look forward to generating and reporting data this year from the NASH and psoriasis trials in which patients will receive daily doses of DUR-928 for 28 days," stated James E. Brown, D.V.M., President and CEO of DURECT. "In addition, we will be requesting approval of POSIMIR when we submit to the FDA a full response to the Complete Response Letter. If successful, this could lead to FDA approval this year. Also, Indivior announced that the commercial launch of PERSERIS in the U.S. took place in February 2019. We receive quarterly earn-out payments on U.S. net sales of PERSERIS."
Potential milestones in 2019:
Update on Selected Programs and Transactions:
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, in acute organ injuries such as AH and acute kidney injury (AKI), and in inflammatory skin disorders such as psoriasis and atopic dermatitis.
Clinical Trials
Non-Alcoholic Steatohepatitis (NASH)
Alcoholic Hepatitis (AH)
Psoriasis
POSIMIR® (bupivacaine extended-release solution) 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.
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.
Methydur Sustained Release Capsules (ORADUR®-methylphenidate ER Capsules). In September 2018, our licensee, 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 Orient Pharma 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. 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.
Earnings Conference Call
A live audio webcast of a conference call to discuss fourth quarter 2018 and year ended December 31, 2018 results and provide a corporate update will be broadcast live over the internet at 4:30 p.m. Eastern Time on March 7 and is available by accessing DURECT's homepage at www.durect.com and clicking "Investor Relations." A replay of 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) and acute kidney injury (AKI), hepatic diseases such as nonalcoholic steatohepatitis (NASH), 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® (bupivacaine extended-release solution), 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 receives 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 continuation of the Phase 2a trial in AH, plans for a Phase 2a trial in psoriasis and a Phase 1b trial in patients with NASH, and the anticipated disclosure of data from clinical trials, potential future payments from Indivior and Orient Pharma, potential regulatory approval of POSIMIR, and the potential benefits and uses of our drug candidates, including the potential use of DUR-928 to treat acute organ injury such as Alcoholic Hepatitis (AH) and acute kidney injury (AKI), hepatic diseases such as nonalcoholic steatohepatitis (NASH), and inflammatory skin conditions such as psoriasis and atopic dermatitis, 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, do not replicate the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, the risk that the FDA will not approve POSIMIR, the risk that Indivior's PERSERIS will not obtain marketplace acceptance, the risk that Orient Pharma will not launch sales of Methydur Sustained Release Capsules as planned, 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 November 8, 2018 under the heading "Risk Factors."
DURECT CORPORATION |
||||||||
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS |
||||||||
(in thousands, except per share amounts) |
||||||||
(unaudited) |
||||||||
Three months ended |
Twelve months ended |
|||||||
December 31 |
December 31 |
|||||||
2018 |
2017 |
2018 |
2017 |
|||||
Collaborative research and development and other revenue |
$ 775 |
$16,273 |
$ 8,207 |
$23,577 |
||||
Product revenue, net |
2,852 |
3,265 |
10,357 |
13,093 |
||||
Revenue from sale of intellectual property rights |
- |
- |
- |
12,500 |
||||
Total revenues |
3,627 |
19,538 |
18,564 |
49,170 |
||||
Operating expenses: |
||||||||
Cost of product revenues |
1,093 |
1,061 |
4,263 |
6,633 |
||||
Research and development |
5,887 |
6,604 |
25,501 |
31,609 |
||||
Selling, general and administrative |
3,539 |
3,303 |
12,419 |
13,165 |
||||
Total operating expenses |
10,519 |
10,968 |
42,183 |
51,407 |
||||
Income (loss) from operations |
(6,892) |
8,570 |
(23,619) |
(2,237) |
||||
Other income (expense): |
||||||||
Interest and other income |
238 |
287 |
870 |
967 |
||||
Interest and other expense |
(645) |
(622) |
(2,573) |
(2,425) |
||||
Net other expense |
(407) |
(335) |
(1,703) |
(1,458) |
||||
Net income (loss) |
$ (7,299) |
$ 8,235 |
$(25,322) |
$ (3,695) |
||||
Net income (loss) per share |
||||||||
Basic |
$ (0.05) |
$ 0.06 |
$ (0.16) |
$ (0.03) |
||||
Diluted |
$ (0.05) |
$ 0.05 |
$ (0.16) |
$ (0.03) |
||||
Weighted-average shares used in computing net income (loss) per share |
||||||||
Basic |
162,040 |
149,428 |
159,834 |
145,273 |
||||
Diluted |
162,040 |
150,759 |
159,834 |
145,273 |
||||
Total comprehensive income (loss) |
$ (7,299) |
$ 8,234 |
$(25,321) |
$ (3,693) |
DURECT CORPORATION |
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CONDENSED BALANCE SHEETS |
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(in thousands) |
|||
As of |
As of |
||
December 31, 2018 |
December 31, 2017(1) |
||
(unaudited) |
|||
ASSETS |
|||
Current assets: |
|||
Cash and cash equivalents |
$ 31,644 |
$ 29,375 |
|
Short-term investments |
2,671 |
7,384 |
|
Accounts receivable |
1,757 |
2,376 |
|
Inventories, net |
3,421 |
3,163 |
|
Prepaid expenses and other current assets |
2,247 |
3,060 |
|
Total current assets |
41,740 |
45,358 |
|
Property and equipment, net |
605 |
929 |
|
Goodwill |
6,399 |
6,399 |
|
Long-term restricted Investments |
150 |
150 |
|
Other long-term assets |
1,105 |
277 |
|
Total assets |
$ 49,999 |
$ 53,113 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||
Current liabilities: |
|||
Accounts payable |
$ 1,589 |
$ 1,520 |
|
Accrued liabilities |
4,668 |
5,511 |
|
Contract research liability |
1,405 |
834 |
|
Deferred revenue, current portion |
- |
682 |
|
Term loan, current portion, net |
- |
7,281 |
|
Total current liabilities |
7,662 |
15,828 |
|
Deferred revenue, noncurrent portion |
812 |
1,093 |
|
Term loan, noncurrent portion, net |
20,533 |
13,578 |
|
Other long-term liabilities |
992 |
1,126 |
|
Stockholders' equity |
20,000 |
21,488 |
|
Total liabilities and stockholders' equity |
$ 49,999 |
$ 53,113 |
(1) Derived from audited financial statements. |
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SOURCE DURECT Corporation