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Durect Corp (DRRX) SEC Filing 10-K Annual report for the fiscal year ending Monday, December 31, 2018

Durect Corp

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CIK: 1082038 Ticker: DRRX

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.  

 

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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.

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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.

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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:

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

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

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Completing the 90 mg cohort in severe AH patients

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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

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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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Inside Durect Corp's 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Balance Sheets
Balance Sheets (Parenthetical)
Statement Of Cash Flows
Statement Of Cash Flows (Parenthetical)
Statement Of Stockholders' Equity
Statement Of Stockholders' Equity (Parenthetical)
Statements Of Operations And Comprehensive Loss
Commitments
Commitments (Tables)
Commitments - Additional Information (Detail)
Commitments - Schedule Of Future Operating Lease Minimum Payments (Detail)
Commitments - Summary Of Lease Arrangements Of Company Facilities (Detail)
Financial Instruments
Financial Instruments (Tables)
Financial Instruments - Additional Information (Detail)
Financial Instruments - Fair Value Measurements Of Assets (Detail)
Financial Instruments - Summary Of Cost And Estimated Fair Value Of Available-For-Sale Securities By Contractual Maturity (Detail)
Financial Instruments - Summary Of Money Market Funds And Available-For-Sale Securities (Detail)
Income Taxes
Income Taxes (Tables)
Income Taxes - Additional Information (Detail)
Income Taxes - Reconciliation Of Income Tax Expenses (Benefit) (Detail)
Income Taxes - Reconciliation Of Unrecognized Tax Benefits (Detail)
Income Taxes - Summary Of Components Of Company's Deferred Tax Assets (Detail)
Property And Equipment
Property And Equipment (Tables)
Property And Equipment - Additional Information (Detail)
Property And Equipment - Property And Equipment (Detail)
Restricted Investments
Restricted Investments - Additional Information (Detail)
Schedule Ii-Valuation And Qualifying Accounts
Schedule Ii-Valuation And Qualifying Accounts (Detail)
Stockholders' Equity
Stockholders' Equity (Tables)
Stockholders' Equity - 2000 Directors' Stock Option Plan - Additional Information (Detail)
Stockholders' Equity - 2000 Employee Stock Purchase Plan - Additional Information (Detail)
Stockholders' Equity - 2000 Stock Plan (Incentive Stock Plan) - Additional Information (Detail)
Stockholders' Equity - Common Stock - Additional Information (Detail)
Stockholders' Equity - Determining Fair Value - Additional Information (Detail)
Stockholders' Equity - Summary Of Assumptions Used To Estimate Fair Value Of Options Granted And Shares Purchased (Detail)
Stockholders' Equity - Summary Of Employee Stock-Based Compensation Cost That Has Been Included In Statements Of Operations And Comprehensive Loss (Detail)
Stockholders' Equity - Summary Of Shares Of Common Stock Reserved For Future Issuance (Detail)
Stockholders' Equity - Summary Of Stock Option Activity Under All Stock-Based Compensation Plans (Detail)
Stockholders' Equity - Summary Of Stock Options Outstanding (Detail)
Strategic Agreements
Strategic Agreements (Tables)
Strategic Agreements - Additional Information (Detail)
Strategic Agreements - Agreement With Pain Therapeutics, Inc. - Additional Information (Detail)
Strategic Agreements - Agreement With Sandoz Ag - Additional Information (Detail)
Strategic Agreements - Agreement With Santen Pharmaceutical Co., Ltd. - Additional Information (Detail)
Strategic Agreements - Agreement With Zogenix, Inc. - Additional Information (Detail)
Strategic Agreements - Patent Purchase Agreement With Indivior - Additional Information (Detail)
Strategic Agreements - Summary Of Collaborative Research And Development And Other Revenues Associated With Company's Major Third-Party Collaborators (Detail)
Strategic Agreements - Summary Of Collaborative Research And Development And Other Revenues Associated With Company's Major Third-Party Collaborators (Parenthetical) (Detail)
Strategic Agreements - Summary Of Collaborative Research And Development Revenue Recognized (Detail)
Subsequent Events
Subsequent Events - Additional Information (Detail)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Additional Information (Detail)
Summary Of Significant Accounting Policies - Schedule Of Cumulative Effect Of Changes Made To Balance Sheet For Adoption Of Asc 606 (Detail)
Summary Of Significant Accounting Policies - Schedule Of Impact Of Adoption With New Revenue Standard Requirements On Financial Statements (Detail)
Summary Of Significant Accounting Policies - Summary Of Components Of Inventories (Detail)
Summary Of Significant Accounting Policies - Summary Of Numerators And Denominators In Calculation Of Basic And Diluted Net Loss Per Share (Detail)
Summary Of Significant Accounting Policies - Summary Of Total Revenue By Geographic Region (Detail)
Term Loan
Term Loan (Tables)
Term Loan - Additional Information (Detail)
Term Loan - Schedule Of Future Maturities And Interest Payments Under Term Loan (Detail)
Unaudited Selected Quarterly Financial Data
Unaudited Selected Quarterly Financial Data (Tables)
Unaudited Selected Quarterly Financial Data - Selected Quarterly Financial Data (Detail)
Unaudited Selected Quarterly Financial Data - Selected Quarterly Financial Data (Parenthetical) (Detail)
Ticker: DRRX
CIK: 1082038
Form Type: 10-K Annual Report
Accession Number: 0001564590-19-007004
Submitted to the SEC: Fri Mar 08 2019 11:17:14 AM EST
Accepted by the SEC: Fri Mar 08 2019
Period: Monday, December 31, 2018
Industry: Pharmaceutical Preparations

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