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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 DURECT CORPORATION (Exact name of registrant as specified in its charter) Delaware 94-3297098 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 10 ...

DURECT Corporation (NASDAQ:DRRX) Q2 2023 Earnings Conference Call August 9, 2023 4:30 PM ET Company Participants Timothy Papp - CFO & Secretary James Brown - Co-Founder, CEO, President & Director WeiQi Lin - EVP, Research & Development and Principal Scientist Keith Lui - SVP, Business Development, Commercial & Medical Affairs Conference Call Participants Richard Miller - Cantor Fitzgerald Francois Brisebois - Oppenheimer Antonio Arce - H.C. Wainwright & Co. Sean Kim - JonesTrading Operator Greetings, and we ...

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, 2023 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 Corporation (NASDAQ:DRRX) Q1 2023 Earnings Conference Call May 8, 2023 4:30 PM ET Company Participants Tim Papp - Chief Financial Officer Jim Brown - Chief Executive Officer Keith Lui - Senior Vice President, Business Development, Commercial, Medical Affairs WeiQi Lin - Executive Vice President, Research and Development, Principal Scientist Norman Sussman - Chief Medical Officer Conference Call Participants Kristen Kluska - Cantor Fitzgerald Ed Arce - H.C. Wainwright Francois Brisebois - Oppenheimer ...

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 March 31, 2023 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) (Registrant's telephone number, including area code) Securi ...

DURECT Corp (NASDAQ:DRRX) Q4 2022 Earnings Conference Call March 7, 2023 4:30 PM ET Company Participants Timothy Papp - CFO & Secretary James Brown - Co-Founder, CEO, President & Director Norman Sussman - Chief Medical Officer Keith Lui - SVP, Business Development, Commercial & Medical Affairs Conference Call Participants Francois Brisebois - Oppenheimer Kristen Kluska - Cantor Fitzgerald Antonio Arce - H.C. Wainwright & Co. Operator Greetings, and welcome to the DURECT Corporation Fourth Quarter 2022 Earni ...

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, 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 ...

Financial Data and Key Metrics Changes - Total revenues in Q3 2022 were $12 million, a significant increase from $2.2 million in Q3 2021, driven by $10 million in milestone payments from the POSIMIR agreement with Innocoll [4] - R&D expenses rose to $9.9 million from $8 million year-over-year, primarily due to higher clinical trial costs and employee benefits [5] - SG&A expenses increased to $3.9 million from $3.2 million, attributed to higher employee benefits, patent expenses, and consulting costs [5] - Cash and investments as of September 30, 2022, were $52 million, down from $70 million at the end of 2021, with a cash burn of $2.3 million during Q3 [6] Business Line Data and Key Metrics Changes - The company reported milestone payments of $10 million from Innocoll related to the POSIMIR product launch in the U.S. [11][25] - The AHFIRM trial for larsucosterol is progressing well, with over 200 patients dosed out of a target of 300, and enrollment expected to complete in Q2 2023 [10][12] Market Data and Key Metrics Changes - Alcoholic Hepatitis (AH) represents a significant healthcare burden, with approximately 158,000 hospitalizations annually in the U.S. and a 90-day mortality rate of about 30% [15] - The average cost of treating a hospitalized AH patient ranges from $53,000 to $147,000, while liver transplant costs can reach approximately $875,000 [16] Company Strategy and Development Direction - The primary focus remains on completing enrollment in the Phase IIb AHFIRM trial for larsucosterol, which has the potential to be the first FDA-approved treatment for AH [10][14] - The company is exploring international market opportunities for larsucosterol, particularly in Europe, where similar trends in AH cases are observed [30][32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the AHFIRM trial's success, citing compelling Phase IIA study data and the drug's mechanism of action [27] - The company is actively working with European data vendors to understand AH diagnoses and educate physicians about the trial [33] Other Important Information - A shareholder meeting is scheduled for November 22 to discuss a potential reverse stock split to maintain NASDAQ listing [7][8] - The FDA has granted fast track designation for the larsucosterol AH program, which could support an NDA filing if the AHFIRM trial is successful [14] Q&A Session Summary Question: How is the company maximizing the opportunity for AH globally? - Management acknowledged the global nature of AH and is working with thought leaders in Europe to address the unmet need and potentially establish partnerships for commercialization [30][31] Question: What is the strategy behind the selection of clinical trial sites? - The company focused on high-volume sites with experienced clinicians to ensure quality data, with plans to expand to broader bases post-approval [36][41] Question: What are the expectations for POSIMIR sales? - Management refrained from projecting sales figures, but noted positive initial feedback from surgeons regarding the product's effectiveness [70] Question: Can you clarify the changes to the mortality or liver transplant endpoint? - The endpoint was adjusted to include liver transplant as a potential outcome, recognizing its significance in patient survival rates [45][48] Question: What is the timeline for data processing after enrollment completion? - Following the completion of enrollment in Q2 2023, data processing is expected to take several months, with a focus on analysis before unblinding [61]

PART I. FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents DURECT Corporation's unaudited condensed financial statements for Q3 and YTD September 30, 2022, including balance sheets, operations, equity, and cash flows [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to $68.5 million from $92.0 million, primarily due to reduced cash and investments, while equity declined from $57.8 million to $34.9 million Condensed Balance Sheet Data (in thousands) | Account | Sep 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $50,394 | $49,844 | | Short-term investments | $1,499 | $19,966 | | Total current assets | $59,346 | $81,737 | | Total assets | $68,472 | $91,990 | | **Liabilities & Equity** | | | | Total current liabilities | $13,357 | $10,056 | | Term loan, non-current portion, net | $17,928 | $20,632 | | Total liabilities | $33,618 | $34,208 | | Total stockholders' equity | $34,854 | $57,782 | [Condensed Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q3 2022 revenues significantly increased to $12.0 million, reducing net loss to $2.5 million, and YTD revenues doubled to $16.0 million, narrowing net loss to $24.9 million Statement of Operations Highlights (in thousands, except per share data) | Metric | Q3 2022 | Q3 2021 | YTD 2022 | YTD 2021 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $11,977 | $2,165 | $15,968 | $6,680 | | Collaborative revenue | $10,585 | $443 | $11,686 | $1,752 | | Product revenue, net | $1,392 | $1,722 | $4,282 | $4,928 | | Research and development | $9,881 | $8,023 | $26,909 | $23,431 | | Loss from operations | $(2,132) | $(9,458) | $(23,584) | $(27,761) | | Net loss | $(2,471) | $(9,977) | $(24,864) | $(29,257) | | Net loss per share (basic) | $(0.01) | $(0.04) | $(0.11) | $(0.13) | [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities improved to $17.9 million for nine months ended Sep 30, 2022, with investing activities providing $18.4 million and financing activities providing minimal cash Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(17,869) | $(26,200) | | Net cash provided by investing activities | $18,360 | $9,919 | | Net cash provided by financing activities | $59 | $50,381 | | Net increase in cash | $550 | $34,100 | [Notes to Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes detail accounting policies, strategic agreements, and financial instruments, confirming sufficient cash for 12 months, significant POSIMIR® milestone revenue, and term loan specifics - The company believes its existing cash, cash equivalents, and investments are sufficient to fund its operating cash flow requirements for a period greater than **12 months** from the date of issuance of these financial statements[29](index=29&type=chunk) - In Q3 2022, the company recognized **$10.0 million** in milestone revenue from its agreement with Innocoll for POSIMIR® This included an **$8.0 million** payment for a new patent issuance and a **$2.0 million** payment for the first commercial sale[47](index=47&type=chunk) - The company has a **$20.0 million** term loan with Oxford Finance, with interest-only payments through June 1, 2023, and a final maturity date of September 1, 2025 The interest rate was **9.86%** as of September 30, 2022[59](index=59&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) MD&A reviews DURECT's business, focusing on larsucosterol and commercial partnerships, detailing increased collaborative revenue, reduced net loss, and confirming sufficient liquidity for the next 12 months [Overview](index=19&type=section&id=Overview) DURECT focuses on larsucosterol, a lead candidate in a Phase 2b trial for AH, and generates revenue from partnerships for POSIMIR®, PERSERIS™, and Methydur - The lead candidate, larsucosterol, is in a **~300-patient Phase 2b clinical trial (AHFIRM)** for alcohol-associated hepatitis (AH) The company anticipates dosing the last patient in the **second quarter of 2023**[69](index=69&type=chunk) - In Q3 2022, DURECT received an **$8.0 million** milestone payment from Innocoll for a new POSIMIR® patent and a **$2.0 million** milestone for the first commercial sale of POSIMIR® in the U.S. The company is also entitled to **low double-digit to mid-teen royalties** on net sales[69](index=69&type=chunk) - The company receives **single-digit sales-based earn-out payments** from Indivior's PERSERIS™ and **single-digit royalties** from Orient Pharma's Methydur[72](index=72&type=chunk) [Results of Operation](index=29&type=section&id=Results%20of%20Operation) Q3 2022 collaborative revenue surged to $10.6 million due to Innocoll milestones, while R&D expenses increased to $9.9 million driven by the larsucosterol program Revenue Breakdown (in thousands) | Revenue Source | Q3 2022 | Q3 2021 | YTD 2022 | YTD 2021 | | :--- | :--- | :--- | :--- | :--- | | Collaborative & Other | $10,585 | $443 | $11,686 | $1,752 | | Product Revenue, Net | $1,392 | $1,722 | $4,282 | $4,928 | R&D Expenses by Program (in thousands) | Program | Q3 2022 | Q3 2021 | YTD 2022 | YTD 2021 | | :--- | :--- | :--- | :--- | :--- | | Larsucosterol | $9,321 | $6,879 | $24,683 | $18,350 | | POSIMIR | $27 | $619 | $517 | $3,078 | | Depot injectable programs | $367 | $341 | $1,173 | $1,044 | | **Total R&D** | **$9,881** | **$8,023** | **$26,909** | **$23,431** | [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2022, the company held $52.0 million in cash and investments, with management confirming sufficient capital for at least 12 months and a $250.0 million shelf registration - Cash, cash equivalents and investments totaled **$52.0 million** at September 30, 2022, down from **$70.0 million** at December 31, 2021[124](index=124&type=chunk) - The company believes its existing cash and investments will be sufficient to fund planned operations, debt, and capital expenditures through at least the **next 12 months** from September 30, 2022[126](index=126&type=chunk) - A shelf registration statement on Form S-3 is effective, allowing the company to offer up to **$250.0 million** of securities, including up to **$75.0 million** of common stock through a sales agreement with Cantor Fitzgerald[126](index=126&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's market risk exposure, primarily related to interest rates on investments and its floating-rate term loan, has not materially changed since December 31, 2021 - As of September 30, 2022, the company's exposure to market risk has not changed materially since **December 31, 2021**[129](index=129&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of September 30, 2022, with no significant changes in 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 quarter[130](index=130&type=chunk) - No significant changes were made to the company's internal control over financial reporting during the most recently completed fiscal quarter[130](index=130&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently a party to any **material legal proceedings**[133](index=133&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) This section details key risks including heavy dependence on larsucosterol, potential COVID-19 related trial delays, reliance on third-party collaborators, significant debt, future capital needs, and Nasdaq listing compliance - The company is highly dependent on the success of its lead product candidate, **larsucosterol**, for which the path to regulatory approval is uncertain[135](index=135&type=chunk)[138](index=138&type=chunk) - The company's stock price does not currently meet the **minimum bid price** for continued listing on Nasdaq, which could lead to delisting and adversely affect liquidity and capital raising ability[137](index=137&type=chunk)[179](index=179&type=chunk) - The **COVID-19 pandemic** has impacted and may continue to adversely impact business operations, including causing delays in clinical trial enrollment and manufacturing[135](index=135&type=chunk)[145](index=145&type=chunk) - The company has a **significant amount of debt**, and failure to comply with repayment obligations or covenants could lead to acceleration of the debt[135](index=135&type=chunk)[149](index=149&type=chunk) [Exhibits](index=57&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including officer certifications and financial statements in Inline XBRL format

DURECT Corporation (NASDAQ:DRRX) Q2 2022 Earnings Conference Call August 4, 2022 4:30 PM ET Company Participants Tim Papp - Chief Financial Officer Jim Brown - Chief Executive Officer Norman Sussman - Chief Medical Officer Conference Call Participants Rick Miller - Cantor Fitzgerald Thomas Yip - H.C. Wainwright Operator Greetings. And welcome to the DURECT Corporation Second Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session w ...