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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Durect Corp | NASDAQ:DRRX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.04 | 4.04% | 1.03 | 1.05 | 1.15 | 1.19 | 0.9712 | 1.02 | 177,793 | 00:35:28 |
CUPERTINO, Calif., March 4, 2021 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months and year ended December 31, 2020 and provided a corporate update.
"We have achieved a number of important milestones over the past few months, most significantly, initiating dosing in the DUR-928 AHFIRM trial in patients with severe alcohol-associated hepatitis (AH) and obtaining Fast Track Designation for that indication," stated James E. Brown, D.V.M., President and CEO of DURECT. "We also obtained FDA approval for POSIMIR® and took steps to strengthen our financial position, our board and our management team as we advance the development of DUR-928, a potentially life-saving therapy for patients with severe AH."
Accomplishments since last earnings call:
Financial highlights for Q4 and full year 2020:
Major activities in 2021:
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, orally bioavailable, first-in-class small molecule, which may have broad applicability in acute organ injuries such as alcohol-associated hepatitis (AH) as well as in chronic liver diseases such as non-alcoholic steatohepatitis (NASH).
Clinical Development
Alcoholic Hepatitis (AH)
Non-Alcoholic Steatohepatitis (NASH)
COVID-19
Since we initiated our clinical trial of DUR-928 in patients with COVID-19, several vaccines and therapeutics for COVID-19 have been approved and are being deployed worldwide. Treatment regimens for patients with COVID-19 have also evolved, the disease landscape has changed and additional therapies have entered clinical trials. Consequently, there have been a limited number of patients eligible or willing to enroll in our trial, and we have elected to discontinue the trial. The people and resources that were supporting the COVID-19 trial are now being redirected to support the AHFIRM trial.
POSIMIR® (bupivacaine solution)
Sale of LACTEL Absorbable Polymers product line
Important additions to our team
Strengthening our financial position
In Q1 2021, DURECT raised net proceeds of $47.8 million from an underwritten public offering and other sales of equity.
Earnings Conference Call
We will host a conference call today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss fourth quarter 2020 results and provide a corporate update:
Thursday, March 4 @ 4:30pm Eastern Time / 1:30 p.m. Pacific Time
Toll Free: | 877-407-0784 |
International: | 201-689-8560 |
Conference ID: | 13715968 |
Webcast: | http://public.viavid.com/index.php?id=143367 |
A live audio webcast of the presentation will be also available by accessing DURECT's homepage at www.durect.com and clicking "Investors." If you are unable to participate during the live webcast, the call will be archived on DURECT's website under "Event Calendar" in the "Investors" section.
About DURECT Corporation
DURECT is a biopharmaceutical company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and potentially lifesaving therapies based on its endogenous epigenetic regulator program. DUR-928, the company's lead drug candidate is in clinical development for the potential treatment of alcohol-associated hepatitis (AH) for which FDA has granted a Fast Track Designation; non-alcoholic steatohepatitis (NASH) is also being explored. In addition, POSIMIR® (bupivacaine solution) for infiltration use, a non-opioid analgesic utilizing the innovative SABER® platform technology, is now FDA-approved. Full prescribing information about POSIMIR, including the Boxed Warning, can be found at www.posimir.com. For more information about DURECT, please visit www.durect.com and follow us on Twitter https://twitter.com/DURECTCorp.
DURECT Forward-Looking Statement
The statements in this press release regarding the potential for DUR-928 to treat patients with AH and NASH, plans to ramp up clinical trial sites and enrollment and initiate ex-US trial sites in the Phase 2b AHFIRM trial, plans to seek a commercialization partner for POSIMIR and its commercial launch, and to enter into additional license and commercialization agreements 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 the AHFIRM trial takes longer to conduct than anticipated due to COVID-19 or other factors, the risk that ongoing and future clinical trials of DUR-928 do not confirm the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy or the life-saving potential of DUR-928 in a statistically significant manner, risks that we may not enter a commercialization partnership for POSIMIR on favorable terms, if at all, risks that we or a third-party collaborator may not commercialize POSIMIR successfully, if at all, and risks related to entering into new agreements or 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 3, 2020 and in our annual report on Form 10-K for the year ended December 31, 2020 when filed with the Securities and Exchange Commission under the heading "Risk Factors." These reports are available on our website www.durect.com under the "Investors" tab.
NOTE: POSIMIR® and SABER® are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. DUR-928 is an investigational drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication. Full prescribing information for POSIMIR, including its Boxed Warning, can be found at www.posimir.com.
DURECT CORPORATION | |||||||||
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) | |||||||||
(in thousands, except per share amounts) | |||||||||
(unaudited) | |||||||||
Three months ended | Twelve months ended | ||||||||
December 31 | December 31 | ||||||||
2020 | 2019 | 2020 | 2019 | ||||||
Collaborative research and development and other revenue | $ 317 | $ 7,249 | $ 23,941 | $ 18,129 | |||||
Product revenue, net | 1,890 | 1,746 | 6,170 | 6,945 | |||||
Total revenues | 2,207 | 8,995 | 30,111 | 25,074 | |||||
Operating expenses: | |||||||||
Cost of product revenues | 418 | 463 | 1,406 | 1,263 | |||||
Research and development | 6,682 | 9,295 | 27,709 | 29,640 | |||||
Selling, general and administrative | 3,413 | 3,705 | 13,611 | 14,115 | |||||
Total operating expenses | 10,513 | 13,463 | 42,726 | 45,018 | |||||
Loss from operations | (8,306) | (4,468) | (12,615) | (19,944) | |||||
Other income (expense): | |||||||||
Interest and other income | 40 | 338 | 517 | 1,074 | |||||
Interest and other expense | (547) | (610) | (2,237) | (2,501) | |||||
Net other expense | (507) | (272) | (1,720) | (1,427) | |||||
Loss from continuing operations | (8,813) | (4,740) | (14,335) | (21,371) | |||||
Income from discontinued operations | 13,173 | 509 | 13,753 | 793 | |||||
Net income (loss) | $ 4,360 | $ (4,231) | $ (582) | $ (20,578) | |||||
Net income (loss) per share | |||||||||
Basic and diluted | |||||||||
Continuing operations | $ (0.04) | $ (0.02) | $ (0.07) | $ (0.12) | |||||
Discontinued operations | $ 0.06 | $ 0.00 | $ 0.07 | $ 0.00 | |||||
Net income (loss) per common share, basic and diluted | $ 0.02 | $ (0.02) | $ (0.00) | $ (0.12) | |||||
Weighted-average shares used in computing net income (loss) per share | |||||||||
Basic | 203,272 | 193,181 | 199,457 | 178,042 | |||||
Diluted | 211,497 | 193,181 | 199,457 | 178,042 | |||||
Total comprehensive income (loss) | $ 4,337 | $ (4,236) | $ (584) | $ (20,581) |
DURECT CORPORATION | ||||
CONDENSED BALANCE SHEETS | ||||
(in thousands) | ||||
As of | As of | |||
December 31, 2020 | December 31, 2019(1) | |||
(unaudited) | ||||
ASSETS | ||||
Current assets: | ||||
Cash and cash equivalents | $ 21,312 | $ 34,924 | ||
Cash held in escrow | 14,979 | - | ||
Short-term investments | 19,421 | 29,750 | ||
Accounts receivable | 940 | 1,516 | ||
Inventories, net | 1,864 | 1,919 | ||
Prepaid expenses and other current assets | 4,545 | 1,424 | ||
Discontinued operations, current portion | - | 2,296 | ||
Total current assets | 63,061 | 71,829 | ||
Property and equipment, net | 251 | 159 | ||
Operating lease right-of-use assets | 4,749 | 5,866 | ||
Goodwill | 6,169 | 6,399 | ||
Long-term investments | 1,000 | - | ||
Long-term restricted Investments | 150 | 150 | ||
Other long-term assets | 261 | 1,085 | ||
Discontinued operations, non-current portion | - | 532 | ||
Total assets | $ 75,641 | $ 86,020 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||
Current liabilities: | ||||
Accounts payable | $ 1,678 | $ 1,982 | ||
Accrued liabilities | 5,801 | 5,940 | ||
Contract research liability | 545 | 3,653 | ||
Deferred revenue, current portion | - | 22,679 | ||
Term loan, current portion, net | 884 | - | ||
Operating lease liabilities, current portion | 1,795 | 1,742 | ||
Discontinued operations, current portion | - | 772 | ||
Total current liabilities | 10,703 | 36,768 | ||
Deferred revenue, noncurrent portion | 812 | 812 | ||
Operating lease liabilities, noncurrent portion | 3,202 | 4,356 | ||
Term loan, noncurrent portion, net | 19,936 | 20,262 | ||
Other long-term liabilities | 873 | 705 | ||
Discontinued operations, non-current portion | - | 257 | ||
Stockholders' equity | 40,115 | 22,860 | ||
Total liabilities and stockholders' equity | $ 75,641 | $ 86,020 | ||
(1) Derived from audited financial statements. | ||||
View original content:http://www.prnewswire.com/news-releases/durect-corporation-announces-fourth-quarter-and-full-year-2020-financial-results-and-update-of-programs-301241036.html
SOURCE DURECT Corporation
Copyright 2021 PR Newswire
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