Exhibit 99.1

 

DURECT Corporation Announces Fourth Quarter and Full Year 2018 Financial Results and Update of Programs

Advancing To Next Dosing Cohort in Severe Alcoholic Hepatitis (AH) Patients

 

Live Webcast of Earnings Call Today at 4:30 p.m. Eastern Time

 

 

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.  

 

Total revenues were $3.6 million and net loss was $7.3 million for the three months ended December 31, 2018 as compared to total revenues of $19.5 million and net profit of $8.2 million for the three months ended December 31, 2017.   Revenues for the three months ended December 31, 2017 included the recognition of $15.4 million in deferred revenue from the $20 million upfront fee associated with our terminated agreement with Sandoz AG.

Total revenues were $18.6 million and net loss was $25.3 million for the year ended December 31, 2018, compared to total revenues of $49.2 million and net loss of $3.7 million for the year ended December 31, 2017.  Revenues for the year ended December 31, 2018 included a $5 million milestone payment from Indivior related to the NDA approval of PERSERIS™ (risperidone); revenues for the year ended December 31, 2017 included a $20 million upfront fee from Sandoz AG and a $12.5 million upfront payment from Indivior.

At December 31, 2018, cash and investments were $34.5 million, compared to cash and investments of $36.9 million at December 31, 2017.  Debt at December 31, 2018, including partial accrual for the final payment of our term loan, was $20.5 million.

  

“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:

Reporting initial data from a DUR-928 multi-dose trial in NASH patients

Reporting top-line data from a DUR-928 Phase 2a proof-of-concept trial in mild to moderate plaque psoriasis patients

Completing the 90 mg cohort in severe AH patients

Submission to and acceptance by the FDA of a full response to the CRL for POSIMIR and potential NDA approval following an expected six-month review period

Commercial launch of PERSERIS by Indivior in the U.S.


The following information was filed by Durect Corp (DRRX) on Thursday, March 7, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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