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, 2025 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 ...

Company Performance - Durect (DRRX) reported a quarterly loss of $0.07 per share, better than the Zacks Consensus Estimate of a loss of $0.13, representing an earnings surprise of +46.15% [1] - The company posted revenues of $0.45 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 39.69%, although this is a decline from year-ago revenues of $2.17 million [2] - Over the last four quarters, Durect has surpassed consensus EPS estimates two times and topped consensus revenue estimates once [2] Stock Performance - Durect shares have increased approximately 149.3% since the beginning of the year, significantly outperforming the S&P 500's gain of 8.4% [3] - The current Zacks Rank for Durect is 3 (Hold), indicating that shares are expected to perform in line with the market in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.18 on $0.3 million in revenues, and for the current fiscal year, it is -$0.66 on $1.19 million in revenues [7] - The outlook for the Medical - Drugs industry, where Durect operates, is currently in the top 35% of over 250 Zacks industries, suggesting a favorable environment for stock performance [8]

Transaction expected to close in the third quarter of 2025 Exhibit 99.1 DURECT Corporation Reports Second Quarter 2025 Financial Results and Provides Update on Proposed Acquisition by Bausch Health Bausch Health will pay $1.75 per share plus up to $350 million in aggregate sales milestones CUPERTINO, Calif., August 12, 2025 /PRNewswire / -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the second quarter ended June 30, 2025 and provided an update on the previously announced acquisi ...

Bausch Health will pay $1.75 per share plus up to $350 million in aggregate sales milestonesTransaction expected to close in the third quarter of 2025CUPERTINO, Calif., Aug. 12, 2025 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the second quarter ended June 30, 2025 and provided an update on the previously announced acquisition of DURECT by Bausch Health Companies Inc. (Bausch Health).Recent business highlights and updates: In July 2025, DURECT announced that it en ...

NEW YORK, July 31, 2025 (GLOBE NEWSWIRE) -- Class Action Attorney Juan Monteverde with Monteverde & Associates PC (the “M&A Class Action Firm”), has recovered millions of dollars for shareholders and is recognized as a Top 50 Firm in the 2024 ISS Securities Class Action Services Report. The firm is headquartered at the Empire State Building in New York City and is investigating DURECT Corporation (NASDAQ: DRRX) related to its sale to Bausch Health Companies Inc. for $1.75 per share in cash. Is it a fair de ...

Core Viewpoint - Bausch Health Companies Inc. has agreed to acquire DURECT Corp, focusing on the development of larsucosterol, a novel therapeutic molecule for alcoholic hepatitis, which currently lacks FDA or EMA approved treatments [1][2][3]. Group 1: Acquisition Details - Bausch Health will pay $1.75 per share in an all-cash transaction, totaling approximately $63 million, with potential milestone payments of up to $350 million [3]. - The acquisition is expected to close in the third quarter of 2025 [6]. Group 2: Clinical Development - A registrational Phase 3 program is planned to evaluate the safety and efficacy of larsucosterol for severe alcoholic hepatitis, with a primary endpoint of 90-day survival [3][4]. - The trial will be randomized, double-blind, placebo-controlled, and will incorporate feedback from the FDA [4]. Group 3: Complementary Programs - The acquisition complements Bausch Health's ongoing RED-C clinical program, which assesses rifaximin SSD for delaying the onset of hepatic encephalopathy hospitalization and all-cause mortality [5]. - Patient enrollment in two global Phase 3 studies for the RED-C program is complete, with results expected in early 2026 [5]. Group 4: Financial Context - Bausch Health is addressing its $21 billion debt, with a third due by 2027, and previously considered selling Bausch + Lomb Corp as part of this strategy [6]. - At the time of publication, Bausch Health's stock was down 0.36% at $6.87, while DURECT's stock rose 238.34% to $1.87 [6].

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, 2025 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 incorpo ...

Larsucosterol Phase 2b AHFIRM trial results published in NEJM Evidence in January 2025 CUPERTINO, Calif., May 13, 2025 /PRNewswire / -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the first quarter ended March 31, 2025 and provided a business update. Exhibit 99.1 DURECT Corporation Reports First Quarter 2025 Financial Results and Provides Business Update Planning a registrational Phase 3 trial for larsucosterol in alcohol-associated hepatitis (AH) with topline results expected wi ...

Clinical Trials and Efficacy - DURECT Corporation's lead candidate, larsucosterol, demonstrated a 41% reduction in mortality at 90 days (p=0.068) for the 30 mg dose and a 35% reduction (p=0.124) for the 90 mg dose compared to placebo in the AHFIRM trial[29]. - The AHFIRM trial enrolled 307 patients with severe alcohol-associated hepatitis (AH), with 76% of patients from the U.S., showing a 57% reduction (p=0.014) in mortality for the 30 mg dose and 58% reduction (p=0.008) for the 90 mg dose in U.S. patients[29]. - The primary endpoint of mortality or liver transplantation at 90 days did not achieve statistical significance for either larsucosterol dose compared to placebo, although numerical improvements were observed[30]. - Larsucosterol 30 mg and 90 mg doses showed 90-day mortality reductions of approximately 41% and 35% compared to placebo, although not statistically significant[33]. - In U.S. patients, 90-day mortality reductions were 57% for the 30 mg group (p=0.014) and 58% for the 90 mg group (p=0.008) compared to placebo[35]. - The Phase 2a clinical trial included 19 patients, with all surviving the 28-day follow-up period and no drug-related serious adverse events reported[43]. - Future clinical trials are required to establish clinically and statistically significant proof of efficacy and safety for larsucosterol[159]. Regulatory Designations and Trials - The FDA granted Breakthrough Therapy Designation to larsucosterol for the treatment of AH in May 2024, with a planned Phase 3 trial to evaluate its safety and efficacy[1]. - The Phase 3 trial is expected to enroll approximately 200 patients in a 1:1 ratio for larsucosterol (30 mg) versus placebo, with a primary outcome measure of 90-day survival[1]. - The planned Phase 3 clinical trial will enroll approximately 200 patients, randomized 1:1 to larsucosterol (30 mg) or placebo, with a primary outcome measure of 90-day survival[46]. - The FDA granted Fast Track Designation for larsucosterol in December 2020 and Breakthrough Therapy Designation in May 2024 for the treatment of alcoholic hepatitis (AH)[45]. - The FDA or other regulatory agencies may require additional information or clinical studies, potentially delaying or preventing regulatory approval for larsucosterol[163]. - The FDA has granted Fast Track and Breakthrough Therapy Designations for larsucosterol, but these designations do not guarantee faster development or approval[175][176]. Financial and Market Considerations - The healthcare costs for hospitalized AH patients are significant, with average charges exceeding $147,000 for patients who died during hospitalization and $53,000 for those discharged[26]. - The average charges for a liver transplant exceed $875,000, with patients requiring lifelong immunosuppressive therapy[27]. - The company is currently facing significant challenges in raising capital to continue operations, with recurring losses and negative cash flows raising doubts about its ability to operate as a going concern[155]. - The company does not have sufficient cash resources to meet its plans for the next twelve months, necessitating additional financing to fund operations[155]. - The company may seek additional funding through equity or debt financings, which could be dilutive to existing stockholders[158]. - The company does not anticipate meaningful revenues from the commercialization of its products and product candidates in the near future, and does not expect revenues to exceed operating expenses[204]. - Indivior accounted for 78% of the company's total revenue in 2024, highlighting the significant reliance on this partnership[76]. - The company sold the ALZET product line for $17.5 million, which may impact future revenue streams[74]. Manufacturing and Supply Chain Risks - The company relies on third-party manufacturers for larsucosterol, increasing the risk of delays in regulatory submissions and commercialization efforts[152]. - The company relies on a limited number of suppliers for key components, which could lead to supply shortages or increased costs[184]. - The company has not established long-term supply agreements for all components, increasing the risk of supply interruptions[186]. - The company anticipates that reliance on third-party contractors for clinical trials and manufacturing may lead to delays and increased expenses if these contractors fail to meet obligations[197]. - Manufacturing delays or issues with third-party contractors could adversely affect the commercialization of larsucosterol[169]. Compliance and Regulatory Challenges - The company faces significant risks related to compliance with FDA regulations, which could delay or preclude the development and marketing of its products[201]. - The FDA's drug development process requires substantial time and financial resources, with no guarantee of timely approval[89]. - Drug manufacturers must adhere to Good Manufacturing Practices (GMP), with risks of non-compliance affecting product availability[104]. - The company may incur significant costs to comply with environmental and health regulations in the future, which could adversely affect its financial condition[209]. - The company may face significant costs and resource diversion due to litigation related to patent rights[84]. Employee and Operational Considerations - As of March 25, 2025, the company had 21 employees, with 43% male and 57% female representation, and 13 employees holding advanced degrees[147]. - The company has reduced its headcount from 58 as of March 26, 2024, to 21 as of March 25, 2025, through targeted reductions and the sale of the ALZET product line[206]. - The company must obtain marketing authorization from foreign regulatory authorities, which varies widely by country[127]. Competitive Landscape - The company faces significant competition from entities with greater resources and capabilities in the pharmaceutical and biotechnology sectors[138]. - The company may experience difficulties in enrolling patients for clinical trials, impacting the timelines for product development[191]. Legislative and Economic Factors - Legislative changes, such as the Affordable Care Act, impose additional fees and rebates on pharmaceutical manufacturers, impacting financial performance[119]. - Future healthcare reforms may impose downward pressure on prices for approved products, potentially harming future revenues[126]. - Macroeconomic uncertainties, including inflation and supply chain disruptions, have adversely impacted the company's operations and may continue to do so[189].

Financial Data and Key Metrics Changes - Total revenues in 2024 were $2 million, a decrease from $2.6 million in 2023, and $0.5 million for the fourth quarter of 2024 compared to $0.9 million for the prior year [5] - R&D expenses were $10.4 million in 2024, down from $29.4 million in the prior year, with fourth quarter expenses at $1.9 million compared to $5.6 million in 2023 [6] - SG&A expenses were $10 million in 2024, compared to $12.7 million in the prior year, and $2 million for the fourth quarter of 2024 compared to $2.2 million for the prior year [7] - Cash and investments at the end of 2024 were $12 million, down from $29.8 million at the end of 2023, with sufficient funds to support operations through the third quarter of 2025 [8] Business Line Data and Key Metrics Changes - The decrease in revenues was attributed to lower earn-out revenue from Indivior, reduced revenue from feasibility agreements, and lower sales of excipients [6] Company Strategy and Development Direction - The company completed the sale of the Allset product line in the fourth quarter of 2024, using proceeds to repay its term loan, resulting in a debt-free status [9] - The focus is on developing larsucosterol for alcohol-associated hepatitis, with plans to explore funding options through strategic partnerships and capital markets [10] Management's Comments on Operating Environment and Future Outlook - Management highlighted the significant mortality associated with alcohol-associated hepatitis, with larsucosterol showing nearly 60% reductions in mortality in Phase 2b trials [11][13] - The FDA granted breakthrough therapy designation for larsucosterol, and the company is committed to advancing its Phase 3 trial, expecting to report top-line data in approximately two years [14][15] Other Important Information - The company is actively exploring strategic partnerships and business development opportunities to support the Phase 3 study [38] Q&A Session Summary Question: Estimated cost of the Phase 3 trial - The estimated cost for the Phase 3 trial is approximately $20 million [18] Question: Clarification on hospitalization to first dose variations - Management explained the importance of timely intervention, noting that in the US, patients are typically treated within four days, while in poorer performing regions, it can take up to two weeks [30] Question: Updates on potential strategic partnerships - The company is actively exploring various possibilities for partnerships to advance the product, though specifics could not be disclosed [38] Question: Possibility of a smaller Phase 2b study - Management indicated that conducting a Phase 3 trial is more efficient than a smaller Phase 2b study, given the need for a larger patient cohort [46] Question: Opportunities for non-funded studies in ex-US countries - There is potential for conducting regional studies with ex-US partners, although the current focus remains solely on alcohol-associated hepatitis [50]