- Total revenues were
$4.6 million and net loss was$8.1 million for the three months endedMarch 31, 2017 as compared to total revenues of$3.6 million and net loss of$7.8 million for the three months endedMarch 31 , 2016. - Subsequent to the end of the first quarter, we signed an agreement with
Sandoz AG pursuant to which we anticipate receiving a$20 million upfront license payment. - At
March 31, 2017 , cash and investments were$16.8 million , compared to cash and investments of$25.2 million atDecember 31 , 2016. Including the upfront license fee fromSandoz less a fee owed to an advisory firm, our pro forma cash and investments atMarch 31, 2017 would have been approximately$36.1 million . Debt atMarch 31, 2017 was$19.9 million .
“We are very pleased to have a company with the market presence and resources of
Update on Selected Programs:
POSIMIR (SABER®-Bupivacaine) Post-Operative Pain Relief Depot. POSIMIR is our investigational post-operative pain relief depot that utilizes our patented SABER technology and is intended to deliver bupivacaine to provide up to 3 days of pain relief after surgery.
- In
May 2017 , we signed a development and commercialization agreement withSandoz AG coveringthe United States . Under the terms of the agreement,Sandoz will make an upfront payment toDURECT of$20 million , with the potential for up to an additional$43 million in development and regulatory milestones, up to an additional$230 million in sales-based milestones, as well as a tiered double digit royalty on product sales in the United States.DURECT will remain responsible for the completion of the ongoing PERSIST Phase 3 clinical trial for POSIMIR as well asFDA interactions through approval. Closing of the transaction is anticipated to occur in the second quarter of 2017 and is contingent solely on the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976. - We expect to finish dosing patients in PERSIST, a POSIMIR Phase 3 clinical trial consisting of patients undergoing laparoscopic cholecystectomy (gallbladder removal) surgery, in the second quarter of 2017 and to have top-line results in the fourth quarter of this year.
- In a previous clinical trial of 50 patients in the same surgical model (laparoscopic cholecystectomy), POSIMIR was compared with the active control bupivacaine HCl, 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) and for the first 2 days after surgery (p=0.0198), using the same statistical methodology specified for the current trial. There can be no assurance that the PERSIST trial will replicate these results.
Epigenetic Regulator Program. DUR-928, the lead product candidate in our Epigenetic Regulator Program, is an endogenous, small molecule, new chemical entity (NCE), which may have broad applicability in several metabolic diseases such as nonalcoholic steatohepatitis (NASH) and other disorders of the liver, in acute organ injuries such as acute kidney injury, and in autoimmune/inflammatory skin disorders such as psoriasis.
- Our first patient trial utilizing DUR-928 was an open-label, single-ascending-dose safety and pharmacokinetic (PK) Phase 1b trial in liver function impaired (NASH) patients and matched control subjects. This study was conducted in
Australia , evaluating single-dose levels (first a low dose and then a high dose) of orally administered DUR-928 in successive cohorts. Twenty subjects with NASH and 12 matched control subjects received DUR-928. - A poster reporting results from this study was presented at the
International Liver Congress ™ 2017 organized by theEuropean Association for the Study of the Liver (EASL) inAmsterdam onApril 22 , 2017. - Although this study was not designed to assess efficacy, we observed a dose dependent reduction of certain biomarkers after a single oral dose of DUR-928. There can be no assurance these results will be confirmed in larger controlled studies.
- The mean decrease of full-length CK-18 (a generalized cell death marker) at 12 hours after dosing was 33% in the NASH patients in the low dose cohort and 41% in the high dose cohort.
- The mean decrease of cleaved CK-18 (a cell apoptosis marker) at 12 hours was 37% in the NASH patients in the low dose cohort and 47% in the high dose cohort.
- The mean decrease in total bilirubin (a liver function marker) at 12 hours in the NASH patients was 27% in the low dose cohort and 31% in the high dose cohort.
- High sensitivity C-Reactive Protein (hsCRP), a marker of inflammation, trended higher at 12 hours in the NASH patients by 3% on average in the low dose cohort but trended lower by 12% on average in the high dose cohort.
- IL-18, an inflammatory mediator implicated in both liver and kidney diseases, trended lower at 12 hours by 5% on average in both the low dose cohort and in the high dose cohort.
- A poster describing results from two STAM™ NASH mouse model studies was presented at the
AASLD Emerging Trends Conference 2017: Emerging Trends in Non-alcoholic Fatty Liver Disease inWashington, DC onMarch 17 , 2017. - We are actively working towards a Phase 2 trial in primary sclerosing cholangitis (PSC), with orally administered DUR-928. PSC is a chronic liver disease characterized by a progression of cholestasis (decrease in bile flow) with inflammation and fibrosis of bile ducts. It is an orphan medical condition for which there is no established medical treatment.
- Our second Phase 1b study with DUR-928, also being conducted in
Australia , is an open-label, single-ascending-dose safety and pharmacokinetic study in patients with impaired kidney function (stage 3 and 4 chronic kidney disease) and matched control subjects. - This study is being conducted in successive cohorts evaluating single-dose levels (first a low dose and then a high dose) of DUR-928 administered by intramuscular injection. The low dose cohort consisted of 6 kidney function impaired patients and 3 matched control subjects.
- Data from the low dose cohort showed the PK parameters between the kidney function impaired patients and the matched control subjects were comparable. After a PK/safety review of this cohort, patients are now being enrolled in the high dose cohort, utilizing a dose four times larger than the low dose cohort. We expect to complete this study shortly.
- We are working closely with expert advisors to design Phase 2 trials in one or more indications with an injectable formulation of DUR-928.
- As previously disclosed, we completed an exploratory Phase 1b trial in psoriasis patients (n = 9 evaluable patients) utilizing intradermal micro injections of DUR-928; promising activity was observed which we believe warrant further investigation.
- In the first quarter of 2017, we developed several topical formulations of DUR-928 that we are evaluating for a topical application microplaque psoriasis trial. We believe that there is a large unmet medical need for new topical drugs for inflammatory skin diseases such as psoriasis or atopic dermatitis for use prior to systemic biologic treatments which often have significant associated side effects.
REMOXY® ER (oxycodone) Extended-Release Capsules CII. Based on our ORADUR technology, the investigational drug REMOXY ER is a unique long-acting formulation of oxycodone designed to discourage common methods of tampering associated with opioid misuse and abuse.
- In
September 2016 ,Pain Therapeutics (our licensee) received a Complete Response Letter from theFDA for REMOXY ER. Based on its review, theFDA has determined that the NDA cannot be approved in its present form and specifies additional actions and data that are needed for drug approval. - In
March 2017 ,Pain Therapeutics announced that it plans to resubmit the REMOXY ER NDA after completing two additional studies regarding REMOXY ER based on guidance obtained in a recent meeting with the FDA. The two studies are a clinical abuse potential study via the intranasal route of abuse and a non-clinical abuse potential study using household solvents. Pain Therapeutics stated that it expects to complete these studies by year end 2017, after which it intends to have a pre-NDA meeting with theFDA followed by resubmission of the REMOXY NDA.
ORADUR-ADHD Program. ORADUR-Methylphenidate is an investigational drug that has the potential for rapid onset of action and long duration with once-a-day dosing, 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 completed dosing a Phase 3 study in
Earnings Conference Call
A live audio webcast of a conference call to discuss first quarter 2017 results and provide a corporate update will be broadcast live over the internet at
About
NOTE: POSIMIR®, SABER®, and ORADUR® are trademarks of
DURECT Forward-Looking Statement
The statements in this press release regarding the potential benefits and uses of our drug candidates, including the potential use of DUR-928 to treat NASH, other disorders of the liver, kidney diseases or psoriasis or other inflammatory conditions, the potential use of POSIMIR to treat pain, the potential abuse deterrent properties of REMOXY ER and the potential use of ORADUR-ADHD to treat ADHD, clinical trial plans for DUR-928, POSIMIR and our other product candidates (including timing and potential results), potential reporting of Phase 3 results for POSIMIR and ORADUR-methylphenidate, potential regulatory approvals of POSIMIR and REMOXY ER, potential markets for our product candidates, potential closing of the agreement with
DURECT CORPORATION |
|||||||
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS |
|||||||
(in thousands, except per share amounts) |
|||||||
(unaudited) |
|||||||
Three months ended |
|||||||
March 31 |
|||||||
2017 |
2016 |
||||||
Collaborative research and development and other revenue |
$ 434 |
$ 419 |
|||||
Product revenue, net |
4,133 |
3,189 |
|||||
Total revenues |
4,567 |
3,608 |
|||||
Operating expenses: |
|||||||
Cost of product revenues |
1,543 |
1,242 |
|||||
Research and development |
7,548 |
6,625 |
|||||
Selling, general and administrative |
3,043 |
3,062 |
|||||
Total operating expenses |
12,134 |
10,929 |
|||||
Loss from operations |
(7,567) |
(7,321) |
|||||
Other income (expense): |
|||||||
Interest and other income |
36 |
27 |
|||||
Interest and other expense |
(583) |
(558) |
|||||
Net other income (expense) |
(547) |
(531) |
|||||
Net loss |
$ (8,114) |
$ (7,852) |
|||||
Net loss per share |
|||||||
Basic |
$ (0.06) |
$ (0.06) |
|||||
Diluted |
$ (0.06) |
$ (0.06) |
|||||
Weighted-average shares used in computing net loss per share |
|||||||
Basic |
141,815 |
122,149 |
|||||
Diluted |
141,815 |
122,149 |
|||||
Total comprehensive loss |
$ (8,116) |
$ (7,835) |
DURECT CORPORATION |
||||
CONDENSED BALANCE SHEETS |
||||
(in thousands) |
||||
As of |
As of |
|||
March 31, 2017 |
December 31, 2016(1) |
|||
(unaudited) |
||||
ASSETS |
||||
Current assets: |
||||
Cash and cash equivalents |
$ 4,272 |
$ 5,404 |
||
Short-term investments |
12,406 |
19,600 |
||
Accounts receivable |
2,076 |
1,154 |
||
Inventories |
3,462 |
3,782 |
||
Prepaid expenses and other current assets |
2,905 |
2,486 |
||
Total current assets |
25,121 |
32,426 |
||
Property and equipment, net |
1,191 |
1,297 |
||
Goodwill |
6,399 |
6,399 |
||
Long-term restricted Investments |
150 |
150 |
||
Other long-term assets |
236 |
236 |
||
Total assets |
$ 33,097 |
$ 40,508 |
||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||
Current liabilities: |
||||
Accounts payable |
$ 1,138 |
$ 2,086 |
||
Accrued liabilities |
3,289 |
5,060 |
||
Contract research liability |
787 |
783 |
||
Deferred revenue, current portion |
1,016 |
968 |
||
Term loan, current portion, net |
1,272 |
19,853 |
||
Total current liabilities |
7,502 |
28,750 |
||
Deferred revenue, noncurrent portion |
1,822 |
1,879 |
||
Term loan, noncurrent portion, net |
18,597 |
– |
||
Other long-term liabilities |
1,929 |
1,541 |
||
Stockholders’ equity |
3,247 |
8,338 |
||
Total liabilities and stockholders’ equity |
$ 33,097 |
$ 40,508 |
||
(1) Derived from audited financial statements. |
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/durect-corporation-announces-first-quarter-2017-financial-results-and-provides-corporate-update-300455343.html
SOURCE
Matt Hogan, Chief Financial Officer, DURECT Corporation, 408-777-4936 or Matthew Duffy, Managing Director, LifeSci Advisors, 212-915-0685