PR Newswire
CUPERTINO, Calif., Aug. 1, 2019
CUPERTINO, Calif., Aug. 1, 2019 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months ended June 30, 2019 and provided a corporate update.
"The second quarter was very productive, with multiple important milestones achieved, including announcing compelling preliminary data from the first 10 alcoholic hepatitis (AH) patients, announcing that the preliminary data from the completed 90 mg severe cohort was consistent with the first 10 patients, and proceeding to the 150 mg severe cohort in the ongoing DUR-928 alcoholic hepatitis trial," stated James E. Brown, D.V.M., President and CEO of DURECT. "We also successfully submitted a full response to the POSIMIR® CRL seeking FDA approval, and received a user fee goal date for FDA response of December 27, 2019. In addition, in July we executed an exclusive license agreement with Gilead for a long-acting injectable HIV investigational product utilizing DURECT's SABER® technology, entailing an upfront fee of $25 million, up to $145 million in additional milestone payments plus royalties and an exclusive option to license additional SABER-based products directed to HIV and HBV for an additional $150 million per product in upfront and milestones plus royalties."
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 acute organ injuries such as AH and acute kidney injury (AKI), in chronic liver diseases such as non-alcoholic steatohepatitis (NASH), and in inflammatory skin disorders such as psoriasis and atopic dermatitis.
Clinical Trials
Alcoholic Hepatitis (AH)
Non-Alcoholic Steatohepatitis (NASH)
Psoriasis
POSIMIR® (bupivacaine extended-release solution) Post-Operative Pain Relief Depot. POSIMIR is our investigational post-operative pain relief depot that utilizes our patented SABER® technology and is designed to deliver bupivacaine to provide up to 3 days of pain relief after surgery.
Gilead Agreement. In July 2019, we entered into an agreement with Gilead Sciences, Inc. (Gilead) granting Gilead the exclusive worldwide rights to develop and commercialize a long-acting injectable HIV investigational product utilizing our SABER technology. Gilead also received exclusive access to the SABER platform for HIV and Hepatitis B Virus (HBV) and the exclusive option to license additional SABER-based products directed to HIV and HBV. Under the terms of the agreement, Gilead made an upfront payment to us of $25 million, with the potential for up to an additional $75 million in development and regulatory milestones, up to an additional $70 million in sales based milestones, as well as tiered royalties on product sales. Gilead has the exclusive option to license additional SABER-based products directed to HIV and HBV for an additional $150 million per product in upfront, development, regulatory and sales based milestones as well as tiered royalties on sales. The parties will collaborate on specified development activities with Gilead controlling and funding the development programs.
Indivior Agreement and PERSERIS™. In September 2017, we entered into a patent purchase agreement with an affiliate of Indivior PLC, whereby we assigned certain of our U.S. patent rights to Indivior. Under the terms of the agreement, Indivior paid us $12.5 million upfront and a $5 million milestone based on NDA approval of PERSERIS (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. We also receive quarterly earn-out payments 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 into at least 2026.
Financing. In June 2019, we raised net proceeds of approximately $15.0 million in a registered offering of the Company's common stock.
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 second quarter 2019 results and provide a corporate update:
Toll Free: | 877-407-0784 |
International: | 201-689-8560 |
Conference ID: | 13692344 |
Webcast: |
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 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), chronic 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. Key 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, a long-acting injectable SABER-based HIV investigational product being developed with Gilead, and ORADUR™-Methylphenidate ER Capsules, approved as Methydur Sustained Release Capsules in Taiwan, 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 commercially launched in February 2019. In July 2019 we executed an exclusive license agreement with Gilead for a long-acting injectable HIV investigational product utilizing DURECT's SABER® technology, entailing an upfront fee of $25 million, up to $145 in additional milestone payments plus tiered royalties and an exclusive option to license additional SABER-based products directed to HIV and HBV for an additional $150 million per product in upfront and milestones plus royalties. For more information about DURECT, please visit www.durect.com.
NOTE: POSIMIR®, SABER® and ORADUR™ 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 the potential benefits and uses of DURECT's drug candidates, including, but not limited to, the potential use of DUR-928 to treat alcoholic hepatitis, hepatic and renal diseases such as NASH, and inflammatory skin conditions such as psoriasis and atopic dermatitis, the potential use of POSIMIR to treat post-operative pain, the potential of the long-acting injectable SABER-based investigational product being developed with Gilead to treat HIV, the potential use of ORADUR-Methylphenidate to treat ADHD, the potential for sales-based earn-out payments from the sale of Indivior's PERSERIS to treat schizophrenia, and the potential development of a long-acting injectable SABER-based HIV product with Gilead and associated potential payments to DURECT 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 possibility that studies of DUR-928 will not replicate results from earlier preclinical or clinical trials, the risks that PERSERIS will not obtain market acceptance and meaningful sales, as well as possible adverse events associated with the use of PERSERIS, POSIMIR, ORADUR-Methylphenidate, the long-acting injectable SABER-based HIV investigational product being developed with Gilead, and DUR-928, and delays and costs due to additional work or other requirements imposed by regulatory agencies for continued development, approval or sale of POSIMIR, the long-acting injectable SABER-based HIV investigational product being developed with Gilead, ORADUR-Methylphenidate and DUR-928. Further information regarding these and other risks related to DURECT is included in DURECT's Form 10-Q filed on May 8, 2019 under the heading "Risk Factors."
DURECT CORPORATION | ||||||||
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS | ||||||||
(in thousands, except per share amounts) | ||||||||
(unaudited) | ||||||||
Three months ended | Six months ended | |||||||
June 30 | June 30 | |||||||
2019 | 2018 | 2019 | 2018 | |||||
Collaborative research and development and other revenue | $ 1,639 | $ 645 | $ 3,139 | $ 1,741 | ||||
Product revenue, net | 2,346 | 2,768 | 4,977 | 5,160 | ||||
Total revenues | 3,985 | 3,413 | 8,116 | 6,901 | ||||
Operating expenses: | ||||||||
Cost of product revenues | 879 | 1,084 | 2,015 | 2,258 | ||||
Research and development | 6,598 | 6,120 | 12,849 | 13,072 | ||||
Selling, general and administrative | 3,278 | 2,816 | 6,732 | 6,010 | ||||
Total operating expenses | 10,755 | 10,020 | 21,596 | 21,340 | ||||
Loss from operations | (6,770) | (6,607) | (13,480) | (14,439) | ||||
Other income (expense): | ||||||||
Interest and other income | 177 | 240 | 386 | 398 | ||||
Interest and other expense | (634) | (644) | (1,263) | (1,267) | ||||
Net other expense | (457) | (404) | (877) | (869) | ||||
Net loss | $ (7,227) | $ (7,011) | $ (14,357) | $ (15,308) | ||||
Net loss per share | ||||||||
Basic | $ (0.04) | $ (0.04) | $ (0.09) | $ (0.10) | ||||
Diluted | $ (0.04) | $ (0.04) | $ (0.09) | $ (0.10) | ||||
Weighted-average shares used in computing net loss per share | ||||||||
Basic | 164,359 | 161,621 | 163,219 | 157,612 | ||||
Diluted | 164,359 | 161,621 | 163,219 | 157,612 | ||||
Total comprehensive loss | $ (7,230) | $ (7,010) | $ (14,364) | $ (15,307) |
DURECT CORPORATION | ||||
CONDENSED BALANCE SHEETS | ||||
(in thousands) | ||||
As of | As of | |||
June 30, 2019 | December 31, 2018(1) | |||
(unaudited) | ||||
ASSETS | ||||
Current assets: | ||||
Cash and cash equivalents | $ 36,943 | $ 31,644 | ||
Short-term investments | 996 | 2,671 | ||
Accounts receivable | 2,142 | 1,757 | ||
Inventories, net | 3,665 | 3,421 | ||
Prepaid expenses and other current assets | 1,336 | 2,247 | ||
Total current assets | 45,082 | 41,740 | ||
Property and equipment, net | 533 | 605 | ||
Operating lease right-of-use assets | 6,717 | - | ||
Goodwill | 6,399 | 6,399 | ||
Long-term restricted Investments | 150 | 150 | ||
Other long-term assets | 1,106 | 1,105 | ||
Total assets | $ 59,987 | $ 49,999 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||
Current liabilities: | ||||
Accounts payable | $ 2,012 | $ 1,589 | ||
Accrued liabilities | 4,377 | 4,668 | ||
Contract research liability | 1,204 | 1,405 | ||
Term loan, current portion, net | 972 | - | ||
Operating lease liabilities, current portion | 2,014 | - | ||
Total current liabilities | 10,579 | 7,662 | ||
Deferred revenue, noncurrent portion | 812 | 812 | ||
Operating lease liabilities, noncurrent portion | 5,143 | - | ||
Term loan, noncurrent portion, net | 19,838 | 20,533 | ||
Other long-term liabilities | 721 | 992 | ||
Stockholders' equity | 22,894 | 20,000 | ||
Total liabilities and stockholders' equity | $ 59,987 | $ 49,999 | ||
(1) Derived from audited financial statements. |
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SOURCE DURECT Corporation
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