UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 000-31615 DURECT CORPORATION (Exact name of registrant as specified in its charter) Delaware 94-3297098 (State or other jurisdiction of incorpor ...

DURECT Corp, Inc. (NASDAQ:DRRX) Q1 2022 Earnings Conference Call May 4, 2022 4:30 PM ET Company Participants Matthew Hogan - IR James Brown - Co-Founder, CEO, President & Director Norman Sussman - Chief Medical Officer Conference Call Participants François Brisebois - Oppenheimer Thomas Yip - HC Wainwright Geoffrey de Sibert - KB Advisors Matthew Hogan Good afternoon, and welcome to our First Quarter 2022 Earnings Conference Call. This is Matt Hogan, from DURECT Corporation. Before beginning, I'd like to re ...

Financial Performance - Total revenues for the three months ended March 31, 2022, were $1.915 million, a decrease of 13.4% compared to $2.212 million for the same period in 2021[19]. - The net loss for the three months ended March 31, 2022, was $10.842 million, compared to a net loss of $10.134 million for the same period in 2021, indicating a 7% increase in losses[19]. - The company reported a basic and diluted net loss per share of $0.05 for the three months ended March 31, 2022, consistent with the same period in 2021[19]. - Total revenue from collaborative research and development for the three months ended March 31, 2022, was $495,000, compared to $574,000 for the same period in 2021, reflecting a decrease of approximately 13.8%[49]. - Net product revenues were $1.4 million for the three months ended March 31, 2022, compared to $1.6 million for the corresponding period in 2021, primarily due to lower sales of the ALZET mini pump product line[115]. Cash and Liquidity - Cash and cash equivalents as of March 31, 2022, were $49.440 million, a slight decrease from $49.844 million as of December 31, 2021[17]. - The company anticipates that existing cash and investments will be sufficient to fund operations for more than 12 months from the date of the financial statements[33]. - As of March 31, 2022, the company had cash, cash equivalents, and investments totaling $64.4 million, down from $70.0 million at December 31, 2021[126]. - The company used $5.6 million in operating activities for the three months ended March 31, 2022, compared to $10.7 million for the same period in 2021, indicating a reduction in cash used for operations[126]. - The company expects to incur continuing losses and negative cash flows from operations for the foreseeable future[110]. Research and Development - Research and development expenses increased to $8.211 million for the three months ended March 31, 2022, compared to $7.975 million for the same period in 2021, reflecting a rise of 2.9%[19]. - The company has several product candidates under development, focusing on new chemical entities and proprietary pharmaceutical programs[30]. - The company expects research and development expenses to increase in the near future due to ongoing costs related to larsucosterol[117]. - Expenses for larsucosterol were $7.3 million in the three months ended March 31, 2022, compared to $5.5 million for the same period in 2021, due to increased clinical trial and contract manufacturing costs[120]. Regulatory and Clinical Trials - The company is exploring potential regulatory filings for larsucosterol and other product candidates, contingent on successful clinical trial outcomes[9]. - The FDA granted larsucosterol Fast Track Designation for the treatment of AH, facilitating expedited development and review[97]. - The ongoing Phase 2b clinical trial (AHFIRM) aims to evaluate the safety and efficacy of larsucosterol in approximately 300 patients with severe AH[72]. - The Phase 2b AHFIRM trial may face delays due to COVID-19 and other logistical challenges, impacting the timeline for top-line data availability[146]. Debt and Financing - The company has a secured term loan of $20 million with a floating interest rate of 7.95% as of March 31, 2022, with interest-only payments until June 1, 2023[62]. - The company may seek additional funding through equity or debt financings, which could be dilutive to existing stockholders[159]. - The company has a term loan with an interest rate of 7.95% as of March 31, 2022, which may increase expenses if prevailing interest rates rise[157]. Market and Competitive Landscape - The company is heavily reliant on the successful development of larsucosterol, which is currently in a Phase 2b clinical trial for severe AH[141]. - The company faces intense competition for qualified personnel, which may impact its ability to attract and retain key staff necessary for its operations[169]. - The pharmaceutical industry is experiencing rapid technological changes, with intense competition from numerous companies, including major players like Pfizer and Novartis[175]. Challenges and Risks - The company may face challenges in raising additional capital, which could adversely affect its operations and financial condition[138]. - The company is dependent on the success of Larsucosterol, with regulatory approval and commercialization paths being uncertain[138]. - The company may need to conduct additional clinical trials or preclinical studies if initial trials yield negative or inconclusive results[146]. - The company faces risks related to the commercialization of larsucosterol, including market access and pricing challenges[143]. Intellectual Property and Compliance - The company owns or exclusively in-licensed over 25 unexpired issued U.S. patents and over 120 unexpired issued foreign patents as of May 3, 2022[172]. - The company faces potential legal disputes regarding intellectual property rights, which could lead to costly litigation and resource diversion[174]. - Compliance with FDA regulations is critical, and failure to meet these requirements could result in product withdrawals or delays, materially harming the business[163]. Future Outlook - The company anticipates limited revenue growth over the next twelve months primarily from the launch of POSIMIR by its licensee, Innocoll[110]. - The company is investing in R&D, allocating $E million towards new technologies and product development[199]. - New product launches are anticipated to drive future growth, with expected contributions of $D million in the upcoming fiscal year[199].

DURECT Corporation (NASDAQ:DRRX) Q4 2021 Earnings Conference Call March 7, 2022 4:30 PM ET Company Participants Mike Arenberg - Chief Financial Officer Matt Hogan - Former Chief Financial Officer Jim Brown - President and CEO Dr. WeiQi Lin - Executive Vice President, R&D and Principal Scientist Norman Sussman - Chief Medical Officer Conference Call Participants Kristen Kluska - Cantor Fitzgerald Francois Brisebois - Oppenheimer Ed Arce - H.C. Wainwright Operator Greetings. And welcome to the DURECT Corporat ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 000-31615 DURECT CORPORATION (Exact name of registrant as specified in its charter) Delaware 94-3297098 (State or other jurisdiction of ...

DURECT Corporation (NASDAQ:DRRX) Q3 2021 Earnings Conference Call November 2, 2021 4:30 PM ET Company Participants Mike Arenberg - Chief Financial Officer Jim Brown - President and Chief Executive Officer Norman Sussman - Chief Medical Officer Conference Call Participants Kristen Kluska - Cantor Fitzgerald Francois Brisebois - Oppenheimer & Company Thomas Yip - H.C. Wainwright Operator Greetings. Welcome to the DURECT Corporation Third Quarter 2021 Earnings Call. [Operator Instructions] Please note this con ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 000-31615 DURECT CORPORATION (Exact name of registrant as specified in its charter) Delaware 94-3297098 (State or other jurisdiction of inc ...

DURECT Corporation (NASDAQ:DRRX) Q2 2021 Results Conference Call July 29, 2021 4:30 PM ET Company Participants Mike Arenberg - CFO Jim Brown - President and CEO Norman Sussman - Chief Medical Officer Conference Call Participants Kristen Kluska - Cantor Fitzgerald Francois Brisebois - Oppenheimer Thomas Yip - H.C. Wainwright Mike Arenberg Good afternoon, and welcome to our Second Quarter 2021 Earnings Conference Call. This is Mike Arenberg, Chief Financial Officer of DURECT Corporation. I will provide a brie ...

PART I. FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company reported a net loss for the three and six months ended June 30, 2021, primarily due to decreased collaborative revenue, with assets increasing from equity financings Condensed Balance Sheet Highlights (in thousands) | Account | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $56,073 | $21,312 | | Total current assets | $95,356 | $63,061 | | Total assets | $106,267 | $75,641 | | Total current liabilities | $8,218 | $10,703 | | Total liabilities | $32,804 | $35,526 | | Total stockholders' equity | $73,463 | $40,115 | Condensed Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $2,303 | $24,498 | $4,515 | $26,093 | | Research and development | $7,433 | $6,567 | $15,408 | $14,154 | | Selling, general and administrative | $3,168 | $3,337 | $6,699 | $6,768 | | Net (loss) income | $(9,146) | $14,338 | $(19,280) | $4,390 | | Net (loss) income per share, basic | $(0.04) | $0.07 | $(0.09) | $0.02 | Condensed Statement of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(18,841) | $(21,640) | | Net cash provided by (used in) investing activities | $3,104 | $(2,945) | | Net cash provided by financing activities | $50,498 | $8,107 | | Net increase (decrease) in cash | $34,761 | $(16,478) | [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes detail accounting policies, strategic agreements, and capital structure, highlighting the Gilead agreement termination, LACTEL sale, and **$47.8 million** in equity financings - The company's business is focused on two main categories: new chemical entities from its Epigenetics Regulator Program and Proprietary Pharmaceutical Programs applying formulation expertise to existing active ingredients[24](index=24&type=chunk) - The company believes its existing cash, cash equivalents, and investments are sufficient to fund operating cash flow requirements for more than 12 months from the financial statement issuance date. However, it has an accumulated deficit of **$509.1 million** and expects continued negative cash flows[28](index=28&type=chunk) - In June 2020, Gilead terminated its license agreement, leading to the recognition of all remaining deferred revenue from a **$35.0 million** upfront fee and milestone payment received in 2019. This resulted in a significant year-over-year decrease in collaborative revenue for 2021[43](index=43&type=chunk) - In February 2021, the company completed an underwritten public offering, raising net proceeds of approximately **$45.4 million**. An additional **$2.4 million** was raised through its sales agreement with Cantor Fitzgerald & Co. in the first six months of 2021[60](index=60&type=chunk) - On December 31, 2020, the company sold its LACTEL Absorbable Polymers product line to Evonik for approximately **$15 million**. The results of this product line are now presented as discontinued operations[61](index=61&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the focus on lead candidate DUR-928 and FDA-approved POSIMIR, noting decreased revenue due to the Gilead agreement termination and increased R&D, with liquidity bolstered by **$51.2 million** in equity financings - The company's lead candidate is DUR-928, an epigenetic regulator being evaluated in a Phase 2b trial (AHFIRM) for severe alcohol-associated hepatitis (AH). A successful trial may support an NDA filing[69](index=69&type=chunk) - POSIMIR, a post-surgical pain product, received FDA approval in February 2021 for use in arthroscopic subacromial decompression. The company is in discussions with potential licensees for commercialization rights[69](index=69&type=chunk)[115](index=115&type=chunk) - The COVID-19 pandemic has negatively impacted the business, causing delays in clinical trial site initiations and patient enrollment. While ALZET product orders have recovered in 2021, the future impact remains uncertain[73](index=73&type=chunk) Revenue Comparison (in thousands) | Revenue Source | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | Collaborative & Other | $735 | $23,347 | $1,309 | $23,317 | | Product Revenue, Net | $1,568 | $1,151 | $3,206 | $2,776 | | **Total Revenues** | **$2,303** | **$24,498** | **$4,515** | **$26,093** | Research & Development Expenses by Program (in thousands) | Program | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | DUR-928 | $5,955 | $5,192 | $11,471 | $10,183 | | POSIMIR | $785 | $597 | $2,459 | $2,288 | | Depot injectable programs | $441 | $271 | $703 | $448 | | Gilead | $0 | $369 | $65 | $816 | | Others | $252 | $138 | $710 | $419 | | **Total R&D** | **$7,433** | **$6,567** | **$15,408** | **$14,154** | - The company's cash, cash equivalents, and investments increased to **$88.6 million** at June 30, 2021, from **$56.9 million** at December 31, 2020, primarily due to net proceeds of **$51.2 million** from equity financings in H1 2021[143](index=143&type=chunk)[144](index=144&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) There have been no significant changes in the company's market risks since the disclosures in its 2020 Annual Report on Form 10-K - There have been no significant changes in market risks as disclosed in the Annual Report on Form 10-K for the year ended December 31, 2020[151](index=151&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were deemed effective, with no significant changes to internal control over financial reporting during the quarter - The Company's principal executive and financial officers concluded that disclosure controls and procedures are effective as of the end of the period covered by the Form 10-Q[152](index=152&type=chunk) - No significant changes in the Company's internal control over financial reporting occurred during the most recently completed fiscal quarter[152](index=152&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not a party to any material legal proceedings[155](index=155&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) Key risks include dependence on DUR-928's clinical success, COVID-19 impacts, challenges with POSIMIR commercialization, significant debt, future capital needs, and reliance on third-party suppliers - The company's business is substantially dependent on the successful development and commercialization of DUR-928, which faces an uncertain regulatory approval path[161](index=161&type=chunk) - The COVID-19 pandemic has disrupted operations, delayed the AHFIRM Phase 2b clinical trial for DUR-928, and may continue to adversely impact business, including clinical trial enrollment and supply chains[166](index=166&type=chunk) - The company is seeking a commercial licensee for POSIMIR and may be unable to enter an agreement. The product's approved indication is limited, which may restrict its market potential[169](index=169&type=chunk) - The company has a significant amount of debt with Oxford Finance, and failure to comply with covenants could lead to acceleration of repayment obligations[174](index=174&type=chunk) - The company will require additional capital in the future and may have difficulty raising it. A history of operating losses is expected to continue[175](index=175&type=chunk)[186](index=186&type=chunk) - Reliance on a limited number of suppliers for key components of products and product candidates, such as DUR-928 and POSIMIR, poses a risk of supply shortages or interruptions[189](index=189&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=62&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - None[216](index=216&type=chunk) [Defaults Upon Senior Securities](index=62&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[216](index=216&type=chunk) [Mine Safety Disclosures](index=62&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[216](index=216&type=chunk) [Other Information](index=62&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this item - None[216](index=216&type=chunk) [Exhibits](index=62&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO/CFO certifications and Interactive Data Files (Inline XBRL) - The report includes CEO and CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[216](index=216&type=chunk) - Interactive Data Files (Inline XBRL) are included as exhibits[216](index=216&type=chunk)

DURECT Corporation (NASDAQ:DRRX) Q1 2021 Earnings Conference Call May 4, 2021 4:30 PM ET Company Participants Mike Arenberg – Chief Financial Officer Jim Brown – President and Chief Executive Officer WeiQi Lin – Executive Vice President-Research and Development, Principal Scientist Norman Sussman – Chief Medical Officer Conference Call Participants Francois Brisebois – Oppenheimer Kristen Kluska – Cantor Fitzgerald Ed Arce – H.C. Wainwright Michael Morabito – Chardan Capital Markets Operator Greetings, and ...