Tillkännagivande • Sep 13
DURECT Corporation(NasdaqCM:DRRX) dropped from NASDAQ Composite Index DURECT Corporation has been dropped from the NASDAQ Composite Index Reported Earnings • Aug 14
Second quarter 2025 earnings: EPS and revenues exceed analyst expectations Second quarter 2025 results: US$0.073 loss per share (improved from US$0.12 loss in 2Q 2024). Revenue: US$447.0k (down 79% from 2Q 2024). Net loss: US$2.27m (loss narrowed 39% from 2Q 2024). Revenue exceeded analyst estimates by 40%. Earnings per share (EPS) also surpassed analyst estimates by 46%. Revenue is expected to decline by 31% p.a. on average during the next 2 years, while revenues in the Pharmaceuticals industry in the US are expected to grow by 8.1%. Over the last 3 years on average, earnings per share has increased by 46% per year but the company’s share price has fallen by 39% per year, which means it is significantly lagging earnings. Tillkännagivande • Jul 29
Bausch Health Companies Inc. (NYSE:BHC) entered into an Agreement and Plan of Merger to acquire DURECT Corporation (NasdaqCM:DRRX) for $55.5 million. Bausch Health Companies Inc. (NYSE:BHC) entered into an Agreement and Plan of Merger to acquire DURECT Corporation (NasdaqCM:DRRX) for $55.5 million on July 28, 2025. Under the terms of the definitive agreement, a wholly owned subsidiary of Bausch Health will commence a tender offer for all outstanding shares of DURECT Corporation. Under the terms of the definitive agreement, Bausch Health will pay $1.75 per share in an all-cash transaction for an upfront consideration of approximately $63 million at closing, with the potential for two additional net sales milestone payments of up to $350 million in the aggregate. Sell side termination fee is $3.5 million. The transaction has been approved by the target and acquirer board of directors. The transaction is conditioned on a majority of the outstanding shares of DURECT Corporation's common stock being tendered into the tender offer and not withdrawn, as well as other customary closing conditions. The transaction is expected to close in the third quarter of 2025. Centerview Partners LLC is serving as exclusive financial advisor and Allison S. Ressler and Scott B. Crofton of Sullivan & Cromwell LLP acted as legal advisor to Bausch Health Americas, Inc. Locust Walk is serving as exclusive financial advisor and Stephen Thau and David Schwartz of Orrick, Herrington and Sutcliffe LLP acted as legal advisor to DURECT Corporation. New Risk • Jul 16
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$16m free cash flow). Earnings are forecast to decline by an average of 46% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$24m net loss next year). Share price has been volatile over the past 3 months (11% average weekly change). Revenue is less than US$5m (US$1.9m revenue). Market cap is less than US$100m (US$16.5m market cap). Tillkännagivande • Jul 13
DURECT Receives Additional 180-Day Grace Period from Nasdaq to Regain Compliance with the Minimum Bid Price Requirement As previously reported on a Current Report on Form 8-K filed with the Securities and Exchange Commission (the ‘SEC’) on January 10, 2025, DURECT Corporation (the ‘Company’) received a letter (the ‘Notice’) from The Nasdaq Stock Market (‘Nasdaq’), dated January 9, 2025, advising the Company that for 30 consecutive trading days preceding the date of the Notice, the bid price of the Company’s common stock had closed below the $1.00 per share minimum required for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the ‘Minimum Bid Price Requirement’). The Notice stated that the Company had 180 days, or until July 8, 2025, to demonstrate its compliance with the Minimum Bid Price Requirement. On July 9, 2025, the Company received approval from the Listing Qualifications Department of Nasdaq for an additional 180-day grace period, or until January 5, 2026, to regain compliance with the Minimum Bid Price Requirement (the ‘Approval’). To regain compliance with the Minimum Bid Price Requirement and qualify for continued listing on The Nasdaq Capital Market, the minimum bid price per share of the Company’s common stock must be at least $1.00 for at least ten consecutive business days during the additional 180-day grace period. If the Company does not regain compliance during this additional grace period, its common stock would be subject to delisting by Nasdaq. As part of its request for an additional 180-day grace period, the Company notified Nasdaq that (i) the Company meets the continued listing standard for market value of publicly-held shares and all other applicable requirements for initial listing standards of The Nasdaq Capital Market, other than the Minimum Bid Price Requirement, and (ii) if the Company’s stock price does not recover sufficiently during the additional grace period, it anticipates implementing and completing a reverse stock split by no later than December 16, 2025, if necessary. The Company intends to continue actively monitoring the closing bid price for the Company’s common stock during the additional grace period, and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance within the additional grace period, Nasdaq will provide notice that the Company’s common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during the 180-day additional grace period or maintain compliance with the other Nasdaq listing requirements. New Risk • May 21
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 44% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$19m free cash flow). Earnings are forecast to decline by an average of 44% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$27m net loss next year). Revenue is less than US$5m (US$1.9m revenue). Market cap is less than US$100m (US$18.9m market cap). Breakeven Date Change • May 21
No longer forecast to breakeven The 2 analysts covering DURECT no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$21.7m in 2027. New consensus forecast suggests the company will make a loss of US$16.5m in 2027. Major Estimate Revision • May 20
Consensus revenue estimates increase by 55%, EPS downgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$770.0k to US$1.19m. EPS estimate fell from -US$0.553 to -US$0.66 per share. Pharmaceuticals industry in the US expected to see average net income decline 2.1% next year. Consensus price target down from US$6.75 to US$5.00. Share price fell 7.4% to US$0.61 over the past week. Reported Earnings • May 15
First quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind First quarter 2025 results: US$0.13 loss per share (improved from US$0.25 loss in 1Q 2024). Revenue: US$321.0k (down 82% from 1Q 2024). Net loss: US$4.16m (loss narrowed 46% from 1Q 2024). Revenue exceeded analyst estimates by 10%. Earnings per share (EPS) missed analyst estimates by 11%. Revenue is forecast to grow 55% p.a. on average during the next 3 years, compared to a 8.3% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 40% per year but the company’s share price has fallen by 47% per year, which means it is significantly lagging earnings. Reported Earnings • Mar 27
Full year 2024 earnings released: US$0.58 loss per share (vs US$1.05 loss in FY 2023) Full year 2024 results: US$0.58 loss per share (improved from US$1.05 loss in FY 2023). Revenue: US$2.03m (down 76% from FY 2023). Net loss: US$18.0m (loss narrowed 35% from FY 2023). Revenue is forecast to grow 54% p.a. on average during the next 3 years, compared to a 8.5% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has fallen by 51% per year, which means it is significantly lagging earnings. Tillkännagivande • Mar 20
DURECT Corporation to Report Q4, 2024 Results on Mar 26, 2025 DURECT Corporation announced that they will report Q4, 2024 results at 4:00 PM, US Eastern Standard Time on Mar 26, 2025 Tillkännagivande • Feb 22
DURECT Corporation Announces Retirement of Terrence F. Blaschke as Board of Director, Member of the Nominating and Corporate Governance Committee On February 14, 2025, Terrence F. Blaschke announced his intention to retire and submitted his immediately effective resignation from the Board of Directors (the “Board”) of DURECT Corporation (the “Company”), including from his role as a member of the Nominating and Corporate Governance Committee of the Board (the “Nominating Committee”). Tillkännagivande • Jan 29
DURECT Corporation Announces Publication of Larsucosterol Phase 2B Results in NEJM Evidence DURECT Corporation announced the publication of a peer-reviewed article on the AHFIRM trial data in NEJM Evidence. The AHFIRM trial was a Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study that evaluated the safety and efficacy of the Company's epigenetic modulator, larsucosterol, for the treatment of subjects with severe alcohol-associated hepatitis (AH). It enrolled 307 patients across three arms: placebo, which consisted of standard of care, with or without methylprednisolone capsules at the investigators' discretion, larsucosterol (30 mg) and larsucosterol (90 mg). A total of 62 centers enrolled patients including 46 US sites that enrolled 76% of patients. Topline results from AHFIRM were previously announced by DURECT. Key data highlights from the AHFIRM trial, include: Both the 30 mg and 90 mg larsucosterol doses demonstrated clinically meaningful trends in reducing 90-day mortality with mortality reductions of 41% (p=0.068) in the 30 mg arm and 35% (p=0.124) in the 90 mg arm compared with placebo. The reductions in mortality at 90 days were more pronounced in U.S. patients with reductions of 57% (p=0.014) in the 30 mg arm and 58% (p=0.008) in the 90 mg arm compared with placebo; computations for random sample analysis suggest that the U.S. results of larsucosterol treatment were unlikely to be an artifact of random chance. The numerical improvement in the primary endpoint of mortality or liver transplant at 90 days did not achieve statistical significance for either dose of larsucosterol. Variations in time from hospitalization to first dose highlighted the importance of timely treatment in patients with severe AH. Larsucosterol appeared safe and well tolerated in the AHFIRM trial and the number of treatment emergent adverse events (TEAEs) and newly-occurring significant complications of liver disease in both larsucosterol groups were similar to those in placebo. AHFIRM was a Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study conducted in subjects with severe alcohol-associated hepatitis (AH) to evaluate the saFety and effIcacy of laRsucosterol treatMent (AHFIRM). The study was comprised of three arms and enrolled 307 patients, with approximately 100 patients in each arm: (1) Placebo, which consisted of standard of care, with or without methylprednisolone capsules at the investigators' discretion; (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). Patients in the larsucosterol arms received the same supportive care without steroids. The primary outcome measure was the 90-day incidence of mortality or liver transplantation for patients treated with larsucosterol compared to those treated with placebo, and the key secondary endpoint was 90-day survival. The Company enrolled patients at clinical trial sites across the U.S., EU, U.K., and Australia. In November 2023, the Company announced topline data for the AHFIRM Trial. Reflecting the life-threatening nature of AH and the lack of therapeutic options, the U.S. Food and Drug Administration (FDA) has granted larsucosterol Fast Track Designation and Breakthrough Therapy Designation for the treatment of AH. Tillkännagivande • Jan 11
DURECT Corporation Receives Non-Compliance Letter from Nasdaq Regarding Minimum Bid Price Requirement On January 9, 2025, DURECT Corporation, a Delaware Corporation (the Company"), received a letter (the Notice") from the Listing Qualifications Department of the Nasdaq Stock Market (Nasdaq") informing the Company that, because the closing bid price for the Company's common stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, the Company is not in compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market, as set in Nasdaq Marketplace Listing Rule 5550(a)(2) (the Minimum Bid Price Requirement"). In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from January 9, 2025, or until July 8, 2025, to regain compliance with the Minimum Bid Price Requirement. If at any time before July 8, 2025, the closing bid price of the Company's common stock closes at or above $1.00 per share for a minimum of 10 consecutive trading days, Nasdaq will provide written notification that the Company has achieved compliance with the Minimum Bid Price Requirement, and the matter will be resolved. If the Company does not regain compliance during the compliance period ending on July 8, 2025, then Nasdaq may grant the Company a second 180 calendar day grace period to regain compliance, provided the Company (i) meets the continued listing requirement for market value of publicly-held shares and all other initial listing standards for The Nasdaq Capital Market, other than the Minimum Bid Price Requirement, and (ii) the Company notifies Nasdaq of its intent to cure the deficiency. The Company intends to continue actively monitoring the closing bid price for the Company's common stock between now and July 8, 2025, and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance within the allotted compliance period, including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that the Company's common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during the 180-day compliance period, secure a second period of 180 calendar days to regain compliance, or maintain compliance with the other Nasdaq listing requirements. Breakeven Date Change • Dec 31
Forecast to breakeven in 2027 The 2 analysts covering DURECT expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$21.7m in 2027. Average annual earnings growth of 60% is required to achieve expected profit on schedule. Major Estimate Revision • Nov 26
Consensus revenue estimates increase by 62% The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$7.96m to US$12.9m. EPS estimate unchanged from -US$0.50 at last update. Pharmaceuticals industry in the US expected to see average net income growth of 0.3% next year. Consensus price target of US$6.75 unchanged from last update. Share price fell 4.5% to US$0.94 over the past week. Major Estimate Revision • Nov 20
Consensus EPS estimates upgraded to US$0.64 loss The consensus outlook for fiscal year 2024 has been updated. 2024 losses forecast to reduce from -US$0.78 to -US$0.643 per share. Revenue forecast steady at US$7.96m. Pharmaceuticals industry in the US expected to see average net income growth of 1.0% next year. Consensus price target of US$6.75 unchanged from last update. Share price fell 24% to US$0.98 over the past week. Reported Earnings • Nov 15
Third quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2024 results: US$0.14 loss per share (further deteriorated from US$0.11 loss in 3Q 2023). Revenue: US$1.93m (up 11% from 3Q 2023). Net loss: US$4.29m (loss widened 42% from 3Q 2023). Revenue missed analyst estimates by 2.4%. Earnings per share (EPS) exceeded analyst estimates by 19%. Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 29% per year but the company’s share price has fallen by 55% per year, which means it is significantly lagging earnings. New Risk • Nov 14
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 54% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$26m free cash flow). Earnings are forecast to decline by an average of 54% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$28m net loss next year). Shareholders have been diluted in the past year (4.1% increase in shares outstanding). Market cap is less than US$100m (US$37.6m market cap). Tillkännagivande • Nov 07
DURECT Corporation to Report Q3, 2024 Results on Nov 13, 2024 DURECT Corporation announced that they will report Q3, 2024 results on Nov 13, 2024 Major Estimate Revision • Aug 20
Consensus revenue estimates decrease by 21%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$10.1m to US$7.98m. EPS estimate increased from -US$0.847 to -US$0.803 per share. Pharmaceuticals industry in the US expected to see average net income decline 1.1% next year. Consensus price target of US$6.75 unchanged from last update. Share price fell 15% to US$1.21 over the past week. Reported Earnings • Aug 15
Second quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2024 results: US$0.12 loss per share (improved from US$0.46 loss in 2Q 2023). Revenue: US$2.17m (up 4.3% from 2Q 2023). Net loss: US$3.70m (loss narrowed 67% from 2Q 2023). Revenue missed analyst estimates by 13%. Earnings per share (EPS) exceeded analyst estimates by 29%. Revenue is forecast to grow 56% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 23% per year but the company’s share price has fallen by 55% per year, which means it is significantly lagging earnings. Board Change • Aug 09
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 4 experienced directors. 2 highly experienced directors. Independent Director Pete Garcia was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Tillkännagivande • Aug 08
DURECT Corporation to Report Q2, 2024 Results on Aug 13, 2024 DURECT Corporation announced that they will report Q2, 2024 results on Aug 13, 2024 Tillkännagivande • Aug 05
DURECT Corporation, Annual General Meeting, Sep 25, 2024 DURECT Corporation, Annual General Meeting, Sep 25, 2024. Tillkännagivande • May 09
DURECT Corporation to Report Q1, 2024 Results on May 13, 2024 DURECT Corporation announced that they will report Q1, 2024 results at 4:00 PM, US Eastern Standard Time on May 13, 2024 Tillkännagivande • Mar 21
DURECT Corporation to Report Q4, 2023 Results on Mar 27, 2024 DURECT Corporation announced that they will report Q4, 2023 results on Mar 27, 2024 Tillkännagivande • Dec 24
DURECT Receives Non-Compliance Notice from Nasdaq Regarding Non-Compliance with the Minimum Bid Price Requirement for Continued Listing on the Nasdaq Capital Market On December 21, 2023, DURECT Corporation (the ‘Company’) received a letter (the ‘Notice’) from the Listing Qualifications Department of the Nasdaq Stock Market (‘Nasdaq’) informing the Company that because the closing bid price for the Company’s common stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, the Company is not in compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market, as set forth in Nasdaq Marketplace Rule 5550(a)(2) (the ‘Minimum Bid Price Requirement’). In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from December 21, 2023, or until June 18, 2024, to regain compliance with the Minimum Bid Price Requirement. If at any time before June 18, 2024, the closing bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of 10 consecutive trading days, Nasdaq will provide written notification that the Company has achieved compliance with the Minimum Bid Price Requirement, and the matter would be resolved. If the Company does not regain compliance during the compliance period ending on June 18, 2024, then Nasdaq may grant the Company a second 180 calendar day grace period to regain compliance, provided the Company (i) meets the continued listing requirement for market value of publicly-held shares and all other initial listing standards for the Nasdaq Capital Market, other than the Minimum Bid Price Requirement, and (ii) the Company notifies Nasdaq of its intent to cure the deficiency. The Company intends to continue actively monitoring the closing bid price for the Company’s common stock between now and June 18, 2024, and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance within the allotted compliance period, including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that the Company’s common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during the 180-day compliance period, secure a second period of 180 calendar days to regain compliance, or maintain compliance with the other Nasdaq listing requirements. Tillkännagivande • Nov 10
DURECT Corporation to Report Q3, 2023 Results on Nov 13, 2023 DURECT Corporation announced that they will report Q3, 2023 results on Nov 13, 2023 Tillkännagivande • Nov 08
DURECT Corporation Announces Topline Results from Phase 2b AHFIRM Trial of Larsucosterol in Alcohol-Associated Hepatitis with Promising Effect on Mortality DURECT Corporation announced topline results from its AHFIRM trial, a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of larsucosterol in 307 patients with severe alcohol-associated hepatitis (AH). Topline data from AHFIRM showed: Both the 30 mg and 90 mg larsucosterol doses demonstrated a compelling and clinically meaningful trend in reduction of mortality at 90 days, the key secondary endpoint, with mortality reductions of 41% (p=0.070) in the 30 mg arm and 35% (p=0.126) in the 90 mg arm compared with SOC. The numerical improvement in the primary endpoint of mortality or transplant at 90 days did not achieve statistical significance for either dose of larsucosterol. Both doses of larsucosterol showed a more pronounced reduction in mortality in patients enrolled in the U.S., representing 76% of patients enrolled in the trial. The reductions in mortality at 90 days were 57% (p=0.014) for the 30 mg arm and 58% (p=0.008) for the 90 mg arm compared with SOC. Larsucosterol was safe and well tolerated. There were fewer treatment-emergent adverse events (TEAEs) in the larsucosterol arms compared with SOC. DURECT intends to have an End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) to discuss the trial results and the Phase 3 registration trial design in the first quarter of 2024. DURECT also intends to present the results of AHFIRM at an upcoming medical meeting. Key AHFIRM trial results: Mortality or Liver Transplantation at 90 Days: The primary endpoint for the AHFIRM trial was the reduction in mortality or liver transplantation at 90 days. The endpoint was analyzed using a hierarchical assessment of patient outcomes to calculate a win probability for each of the 30 mg and 90 mg dose of larsucosterol compared with SOC. The results for the primary endpoint were not statistically significant for either the 30 mg or 90 mg doses compared with SOC, though a numerical improvement was observed. Mortality at 90 Days: Mortality at 90 Days was a key secondary endpoint for the AHFIRM trial. In this analysis, the 30 mg and 90 mg doses of larsucosterol showed numerical trends toward a clinically meaningful survival benefit with 90-day mortality reductions of 41% and 35%, respectively, when compared to SOC, although these results were not statistically significant.Mortality at 90 Days (U.S. patients): When further analyzed by geography, both the 30 mg and 90 mg doses showed an enhanced survival benefit at 90 days with reductions in 90-day mortality of 57% and 58%, respectively, in patients enrolled in the U.S., which represented 76% of the total patients enrolled. Safety and Tolerability: Both the 30 mg and 90 mg doses of larsucosterol were well tolerated. There were fewer TEAEs in the larsucosterol arms compared with SOC. Tillkännagivande • Sep 09
Durect Corporation Announces Last Patient Last Visit in Phase 2B Ahfirm Trial of Larsucosterol in Alcohol-Associated Hepatitis DURECT Corporation announced that the last patient has completed the study protocol in the Company's AHFIRM trial. AHFIRM is a Phase 2b randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of lasucosterol in subjects with severe alcohol-associated hepatitis (AH). A total of 301 patients were randomized and dosed in AHFIRM and DURECT plans to report topline data in the fourth quarter of 2023. Tillkännagivande • Aug 04
DURECT Corporation to Report Q2, 2023 Results on Aug 09, 2023 DURECT Corporation announced that they will report Q2, 2023 results on Aug 09, 2023 Tillkännagivande • Jun 08
DURECT Corporation Completes Enrollment in Phase 2b AHFIRM Trial of Larsucosterol in Alcohol-Associated Hepatitis DURECT Corporation announced that it has completed enrollment in its Phase 2b AHFIRM clinical trial (NCT04563026) investigating larsucosterol for the treatment of patients with severe alcohol-associated hepatitis (AH), achieving its enrollment target of 300 patients. AHFIRM is a Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study in subjects with severe acute alcohol-associated hepatitis (AH) to evaluate saFety and effIcacy of laRsucosterol treatMent (AHFIRM). The study is comprised of three arms evaluating a total of approximately 300 subjects, with approximately 100 patients in each arm: (1) Placebo plus supportive care, with or without methylprednisolone capsules at the investigators’ discretion; (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). Patients in the larsucosterol arms received the same supportive care without steroids. In order to maintain blinding, patients in the two active arms received matching placebo capsules if the investigator prescribed steroids. The primary outcome measure will be the 90-Day incidence of death or liver transplantation for patients treated with larsucosterol compared to those treated with placebo. The Company has enrolled patients at more than 60 clinical trial sites across the U.S., EU, U.K. and Australia. Price Target Changed • Aug 05
Price target decreased to US$5.33 Down from US$6.00, the current price target is an average from 3 analysts. New target price is 791% above last closing price of US$0.60. Stock is down 56% over the past year. The company is forecast to post a net loss per share of US$0.19 next year compared to a net loss per share of US$0.16 last year. Reported Earnings • Aug 05
Second quarter 2022 earnings: EPS and revenues miss analyst expectations Second quarter 2022 results: US$0.051 loss per share (down from US$0.04 loss in 2Q 2021). Revenue: US$2.08m (down 9.9% from 2Q 2021). Net loss: US$11.6m (loss widened 26% from 2Q 2021). Revenue missed analyst estimates by 46%. Earnings per share (EPS) also missed analyst estimates by 7.1%. Over the next year, revenue is forecast to grow 77%, compared to a 18% growth forecast for the industry in the US. Over the last 3 years on average, earnings per share has fallen by 16% per year but the company’s share price has fallen by 25% per year, which means it is performing significantly worse than earnings. Board Change • May 31
High number of new directors Independent Director Pete Garcia was the last director to join the board, commencing their role in 2021. Reported Earnings • May 06
First quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2022 results: US$0.048 loss per share (down from US$0.047 loss in 1Q 2021). Revenue: US$1.92m (down 13% from 1Q 2021). Net loss: US$10.8m (loss widened 7.0% from 1Q 2021). Revenue missed analyst estimates by 16%. Earnings per share (EPS) exceeded analyst estimates by 6.2%. Over the next year, revenue is forecast to grow 21%, compared to a 7.6% growth forecast for the industry in the US. Over the last 3 years on average, earnings per share has fallen by 7% per year but the company’s share price has fallen by 16% per year, which means it is performing significantly worse than earnings. Board Change • Apr 27
High number of new directors Independent Director Pete Garcia was the last director to join the board, commencing their role in 2021. Recent Insider Transactions • Mar 18
Independent Director recently bought US$118k worth of stock On the 14th of March, Judith Robertson bought around 200k shares on-market at roughly US$0.59 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$138k more in shares than they have sold in the last 12 months. Major Estimate Revision • Mar 15
Consensus revenue estimates fall by 16% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$18.2m to US$15.3m. Forecast losses increased from -US$0.16 to -US$0.19 per share. Pharmaceuticals industry in the US expected to see average net income growth of 13% next year. Consensus price target down from US$6.00 to US$5.67. Share price fell 4.7% to US$0.55 over the past week. Breakeven Date Change • Mar 11
No longer forecast to breakeven The 3 analysts covering DURECT no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$41.2m in 2024. New consensus forecast suggests the company will make a loss of US$10.0m in 2024. Reported Earnings • Mar 10
Full year 2021 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2021 results: US$0.16 loss per share (down from US$0.072 loss in FY 2020). Revenue: US$14.0m (down 54% from FY 2020). Net loss: US$36.3m (loss widened 153% from FY 2020). Revenue exceeded analyst estimates by 59%. Earnings per share (EPS) missed analyst estimates by 11%. Over the next year, revenue is forecast to grow 9.7%, compared to a 19% growth forecast for the pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has fallen by 7% per year, which means it is significantly lagging earnings. Board Change • Jan 03
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Director Pete Garcia was the last director to join the board, commencing their role in 2021. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Breakeven Date Change • Jan 02
Forecast to breakeven in 2024 The 3 analysts covering DURECT expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$41.2m in 2024. Average annual earnings growth of 65% is required to achieve expected profit on schedule. Reported Earnings • Nov 05
Third quarter 2021 earnings released: US$0.044 loss per share (vs US$0.046 loss in 3Q 2020) The company reported a poor third quarter result with increased losses, weaker revenues and weaker control over costs. Third quarter 2021 results: Revenue: US$2.17m (down 19% from 3Q 2020). Net loss: US$9.98m (loss widened 6.9% from 3Q 2020). Over the last 3 years on average, earnings per share has increased by 1% per year but the company’s share price has increased by 8% per year, which means it is tracking significantly ahead of earnings growth. Price Target Changed • Aug 06
Price target decreased to US$6.50 Down from US$7.00, the current price target is an average from 3 analysts. New target price is 374% above last closing price of US$1.37. Stock is down 41% over the past year. Reported Earnings • Jul 31
Second quarter 2021 earnings released: US$0.04 loss per share (vs US$0.073 profit in 2Q 2020) The company reported a poor second quarter result with weaker earnings, revenues and control over costs. Second quarter 2021 results: Revenue: US$2.30m (down 91% from 2Q 2020). Net loss: US$9.15m (down 164% from profit in 2Q 2020). Over the last 3 years on average, earnings per share has fallen by 3% per year whereas the company’s share price has remained flat. Price Target Changed • Jun 25
Price target increased to US$7.25 Up from US$6.17, the current price target is an average from 4 analysts. New target price is 326% above last closing price of US$1.70. Stock is down 38% over the past year. Breakeven Date Change • Jun 25
Forecast to breakeven in 2024 The 4 analysts covering DURECT expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$36.8m in 2024. Average annual earnings growth of 73% is required to achieve expected profit on schedule.