On 17 May 2019, DURECT Corporation (NASDAQ:DRRX) oscillated between $0.7000 and $0.7680 before concluding trading period lower/higher +0.36% at $0.7455. The stock recorded total trading quantity of 359,720 shares as compared to its average volume of 515,740 shares.
DURECT Corporation (DRRX) recently reported financial results for the three months and year ended December 31, 2018 and provided a corporate update.
- Total revenues were $3.6M and net loss was $7.3M for the three months ended December 31, 2018 as contrast to total revenues of $19.5M and net profit of $8.2M for the three months ended December 31, 2017. Revenues for the three months ended December 31, 2017 included the recognition of $15.4M in deferred revenue from the $20M upfront fee associated with our terminated contract with Sandoz AG.
- Total revenues were $18.6M and net loss was $25.3M for the year ended December 31, 2018, contrast to total revenues of $49.2M and net loss of $3.7M for the year ended December 31, 2017. Revenues for the year ended December 31, 2018 included a $5M milestone payment from Indivior related to the NDA authorization of PERSERIS™ (risperidone); revenues for the year ended December 31, 2017 included a $20M upfront fee from Sandoz AG and a $12.5M upfront payment from Indivior.
- At December 31, 2018, cash and investments were $34.5M, contrast to cash and investments of $36.9M at December 31, 2017. Debt at December 31, 2018, including partial accrual for the final payment of our term loan, was $20.5M.
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.
- After a comprehensive review of the POSIMIR program in light of the issues raised by the FDA in our communications with them, including the Complete Response Letter (CRL), we are planning to submit a full response to the CRL in the first half of 2019. As the submission will be a response to a CRL, we expect a 6-month FDA review period.
- The effort to evaluate the program, develop a strategy for filing the response, and the actual writing of key sections of the response, has been under the direction of Dr. Lee Simon, who was formerly FDA’s Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products.
- We believe that the completed inguinal hernia and subacromial decompression (shoulder) clinical trials support the efficacy of POSIMIR in post-operative pain and meet the requirements to be considered as adequate and well-controlled pivotal clinical trials. Both trials demonstrated a important decrease in pain and opioid use over the 0-72 hour period following surgery as contrast to placebo.
- We have completed 16 clinical trials in the POSIMIR program, involving over 1,400 patients, over 850 of whom received POSIMIR with the remainder in control groups. We believe this is a sufficiently sized safety database. We believe that, with the PERSIST safety data included, we now have sufficient data to address FDA’s issues raised in the CRL and that the data package meets the requirements for FDA authorization .
- POSIMIR has not been accepted by the FDA for marketing in the U.S. for any indication and there can be no assurance that FDA will approve the planned submission described above.
Indivior Contract and PERSERIS™. In September 2017, the Company entered into a patent purchase contract with an associate 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 contract, Indivior has paid the Company $12.5M upfront and a $5M milestone based on NDA authorization of PERSERIS. The Company also receives 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.
- Through press releases on December 18, 2018, and February 14 and 27, 2019, Indivior has stated that:
- U.S. sales of long acting injectables to treat schizophrenia were in excess of $3B in 2017.
The Company has 161.66 million shares outstanding and 155.93 million shares were floated in market. EPS growth for this year is -523.00% and EPS growth for next year is expected to reach at 0.00%. EPS growth in past five years was 5.30%.