Ankündigung • Jan 20
Opiant Pharmaceuticals Announces FDA Acceptance and Priority Review of NDA for OPNT003, Nasal Nalmefene, for Opioid Overdose Opiant Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for OPNT003, nasal nalmefene, Opiant’s product candidate for the treatment of opioid overdose. The NDA was granted a Priority Review designation and has been given a Prescription Drug User Fee Act (PDUFA) action date of May 22, 2023, accelerating the review time from ten months to six months from the date of filing. Priority Review is granted to therapies that the FDA determines have the potential to provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious condition. Recent Insider Transactions • Jan 09
President recently sold US$102k worth of stock On the 5th of January, Roger Crystal sold around 5k shares on-market at roughly US$20.20 per share. This transaction amounted to 13% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Roger has been a net seller over the last 12 months, reducing personal holdings by US$211k. Major Estimate Revision • Nov 25
Consensus revenue estimates increase by 15% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from US$9.00m to US$10.3m. Forecast losses expected to reduce from -US$8.40 to -US$8.10 per share. Pharmaceuticals industry in the US expected to see average net income growth of 4.7% next year. Consensus price target down from US$40.00 to US$21.50. Share price was steady at US$20.08 over the past week. Price Target Changed • Nov 24
Price target decreased to US$21.50 Down from US$40.00, the current price target is an average from 2 analysts. New target price is 7.1% above last closing price of US$20.08. The company is forecast to post a net loss per share of US$7.39 compared to earnings per share of US$0.68 last year. Ankündigung • Nov 23
Opiant Pharmaceuticals, Inc. Announces Completion of Rolling NDA Submission for OPNT003, Nasal Nalmefene, for Opioid Overdose Opiant Pharmaceuticals, Inc. announced it has completed submission of its rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for OPNT003, nasal nalmefene, for the treatment of opioid overdose. The NDA submission is supported by results from a pharmacokinetic (PK) study comparing OPNT003 to an intramuscular nalmefene injection (NCT04759768), a second PK study comparing a single intranasal dose to a single dose in each nostril or two doses in a single nostril (NCT05219669), and a pharmacodynamic study comparing nasal nalmefene to NARCAN® (naloxone HCI) Nasal Spray 4mg in a clinical model of opioid induced respiratory depression (NCT04828005). The FDA decision on NDA filing acceptance is expected in February 2023. An award from the Biomedical Advanced Research and Development Authority (BARDA) for up to $10.8 million, combined with a $7.4 million grant Opiant received from the National Institute on Drug Abuse, have supported the clinical development and U.S. regulatory submission of OPNT003. The contract with BARDA will potentially allow for the development of OPNT003 as a medical countermeasure in a chemical attack using weaponized synthetic opioids as well as reversal of opioid overdoses in the community. BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). This project has been funded in whole or in part with federal funds from HHS/ASPR/BARDA, under contract number HHSO100201800029C. Major Estimate Revision • Nov 21
Consensus revenue estimates fall by 45% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$16.4m to US$9.00m. Forecast losses increased from -US$7.35 to -US$8.40 per share. Pharmaceuticals industry in the US expected to see average net income growth of 4.5% next year. Consensus price target of US$40.00 unchanged from last update. Share price rose 111% to US$20.09 over the past week. Board Change • Nov 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. 2 highly experienced directors. Independent Chairman Craig Collard was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Ankündigung • Oct 28
Opiant Pharmaceuticals, Inc. to Report Q3, 2022 Results on Nov 14, 2022 Opiant Pharmaceuticals, Inc. announced that they will report Q3, 2022 results After-Market on Nov 14, 2022 Ankündigung • Oct 07
Opiant Pharmaceuticals, Inc. Announces Completion of Enrollment in Phase 2 Clinical Trial of OPNT002, Nasal Naltrexone, in Patients with Alcohol Use Disorder Opiant Pharmaceuticals, Inc. announced that the last patient has been enrolled in the Phase 2 clinical trial of OPNT002, nasal naltrexone, for patients with Alcohol Use Disorder (AUD). The total trial duration per patient is 20 weeks, with the last patient enrolled expected to complete the study in early 2023 and with top line data anticipated to follow mid-year. Opiant launched its Phase 2 clinical study of OPNT002 for the treatment of alcohol use disorder in January 2022. The multi-center, double-blind, randomized, placebo-control Phase 2 study is being conducted in Europe, and is designed to evaluate OPNT002 efficacy, safety, and tolerability in 300 patients with AUD. The trial is being conducted using a Sequential Parallel Comparison Study Design, which is useful in psychiatric studies to reduce the impact of the placebo effect on the assessment of treatment response. The primary end point will be measured by the proportion of patients showing an improvement in World Health Organization (WHO) Risk Levels of Alcohol Consumption consisting of a 2-level reduction from baseline to end of treatment. Ankündigung • Aug 23
Opiant Pharmaceuticals Announces Notice of Allowance for U.S. Patent with Claims Covering Opnt004 for the Treatment of Cannabinoid Hyperemesis Syndrome Opiant Pharmaceuticals, Inc. announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for Opiant’s pipeline candidate OPNT004 (drinabant) for the treatment of cannabinoid hyperemesis syndrome (CHS), a condition among cannabis users that leads to repeated and severe bouts of vomiting. A Notice of Allowance is issued after the USPTO decides that a patent can be granted from an application. The USPTO issued a Notice of Allowance for U.S. Patent Application 16/904,359, entitled “Compositions and methods for treating cannabinoid hyperemesis syndrome with a cannabinoid receptor antagonist” for OPNT004. This patent covers OPNT004 as a method of treatment for CHS using drinabant administered as a parenteral formulation. Opiant expects this patent to issue within the next few months and expire no earlier than 2040. Major Estimate Revision • Aug 18
Consensus revenue estimates fall by 13% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$18.8m to US$16.4m. Forecast losses increased from -US$6.21 to -US$7.35 per share. Pharmaceuticals industry in the US expected to see average net income growth of 2.6% next year. Consensus price target of US$40.25 unchanged from last update. Share price rose 2.2% to US$12.86 over the past week. Reported Earnings • Aug 12
Second quarter 2022 earnings: EPS and revenues miss analyst expectations Second quarter 2022 results: US$2.31 loss per share (down from US$0.39 profit in 2Q 2021). Revenue: US$3.89m (down 65% from 2Q 2021). Net loss: US$11.7m (down US$13.4m from profit in 2Q 2021). Revenue missed analyst estimates by 16%. Earnings per share (EPS) also missed analyst estimates by 69%. Over the next year, revenue is expected to shrink by 12% compared to a 16% growth forecast for the industry in the US. Over the last 3 years on average, earnings per share has fallen by 56% per year but the company’s share price has only fallen by 3% per year, which means it has not declined as severely as earnings. Ankündigung • Aug 10
Opiant Pharmaceuticals Announces Additional $2.1 Million Funding Under BARDA Contract for OPNT003, Nasal Nalmefene Opiant Pharmaceuticals, Inc. announced that the Biomedical Advanced Research and Development Authority (BARDA) has awarded an additional approximately $2.1 million to support OPNT003, nasal nalmefene, for the treatment of opioid overdose. The increase in funding is primarily directed towards the preparation and filing of a New Drug Application (NDA) for OPNT003 to the U.S. Food and Drug Administration (FDA). A record number of people in the United States (U.S.), over 80,000, died of an opioid overdose during the 12 months ending February 2022, according to provisional data from the U.S. Centers for Disease Control and Prevention (CDC). Eighty-nine percent – nearly 73,000 – of opioid overdose deaths were linked to synthetic opioids, driven by fentanyl.1 For each opioid-induced fatality, there are between 6.4-8.4 non-fatal overdoses which can lead to long-term physical and mental disability. OPNT003, a nasal formulation containing the high affinity opioid antagonist, nalmefene, was studied in three clinical trials: a pharmacokinetic (PK) study comparing OPNT003 to an intramuscular nalmefene injection, a second PK study comparing a single intranasal dose to a single dose in each nostril or two doses in a single nostril, and a pharmacodynamic (PD) study comparing nasal nalmefene to nasal naloxone in reversing opioid-induced respiratory depression. The PK studies demonstrated rapid absorption and higher plasma concentrations versus intramuscular injection.3,4 In the PD study, OPNT003 met the primary endpoint of non-inferiority to nasal naloxone, producing a reversal in remifentanil-induced respiratory depression that was nearly twice that produced by nasal naloxone at five minutes.5 Opiant has initiated rolling submission of an NDA to the FDA for OPNT003 using the 505(b)(2) pathway and intends to complete the filing in the second half of 2022. OPNT003 was granted Fast Track Designation in November 2021. Earlier awards from BARDA for $8.7 million, combined with a $7.4 million grant Opiant received from the National Institute on Drug Abuse, have also supported the clinical development and U.S. regulatory submission of OPNT003. The contract with BARDA will also potentially allow for the development of OPNT003 as a medical countermeasure in a chemical attack using weaponized synthetic opioids as well as reversal of opioid overdoses in the community. BARDA is part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number HHSO100201800029C. Ankündigung • Aug 02
Opiant Pharmaceuticals, Inc. to Report Q2, 2022 Results on Aug 11, 2022 Opiant Pharmaceuticals, Inc. announced that they will report Q2, 2022 results After-Market on Aug 11, 2022 Ankündigung • Jun 10
Opiant Pharmaceuticals, Inc. announced that it expects to receive $2.1 million in funding from AptarGroup, Inc., Valois SAS Opiant Pharmaceuticals, Inc. announced that it has entered into a capacity investment agreement with Valois SAS and AptarGroup, Inc. whereby the company will make non-refundable payments in the aggregate amount of approximately $2.1 million over eighteen months on June 8, 2022. Recent Insider Transactions • Jun 08
Independent Director recently sold US$275k worth of stock On the 3rd of June, Michael Sinclair sold around 20k shares on-market at roughly US$13.73 per share. This was the largest sale by an insider in the last 3 months. Despite this recent sale, insiders have collectively bought US$311k more than they sold in the last 12 months. Ankündigung • Jun 03
Opiant Pharmaceuticals Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for OPNT003, Nasal Nalmefene, for the Treatment of Opioid Overdose Opiant Pharmaceuticals, Inc. announced the filing of the first module of its New Drug Application (NDA) for OPNT003, nasal nalmefene, for the treatment of opioid overdose. The module was submitted pursuant to a rolling submission, as agreed with the U.S. Food and Drug Administration (FDA) during a pre-NDA meeting. As communicated previously, the Company expects to complete the submission of the NDA using the 505(b)(2) pathway in the second half of 2022. An estimated record 80,816 Americans died of an opioid overdose in 2021, a 17% increase over 2020 and a 62% increase from 2019, according to new data from the U.S. Centers for Disease Control and Prevention (CDC). Deaths involving synthetic opioids, including fentanyl, increased from 36,359 in 2019 and 56,516 in 2020, to an estimated 71,238 in 2021. Opiant was granted Fast Track designation for OPNT003, nasal nalmefene, in November 2021. The rolling review process allows Opiant to submit completed sections of its NDA for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201800029C; and the National Institute on Drug Abuse (NIDA). Recent Insider Transactions • May 19
Independent Chairman recently bought US$368k worth of stock On the 16th of May, Craig Collard bought around 27k shares on-market at roughly US$13.54 per share. This was the largest purchase by an insider in the last 3 months. Craig has been a buyer over the last 12 months, purchasing a net total of US$626k worth in shares. Major Estimate Revision • May 17
Consensus EPS estimates fall by 47% The consensus outlook for earnings per share (EPS) in 2022 has deteriorated. 2022 revenue forecast decreased from US$20.2m to US$18.8m. Losses expected to increase from US$4.10 per share to US$6.02. Pharmaceuticals industry in the US expected to see average net income growth of 12% next year. Consensus price target broadly unchanged at US$40.25. Share price fell 20% to US$14.70 over the past week. Reported Earnings • May 11
First quarter 2022 earnings: EPS and revenues miss analyst expectations First quarter 2022 results: US$2.43 loss per share (down from US$0.66 loss in 1Q 2021). Revenue: US$4.47m (down 30% from 1Q 2021). Net loss: US$12.2m (loss widened 329% from 1Q 2021). Revenue missed analyst estimates by 24%. Earnings per share (EPS) also missed analyst estimates by 224%. Over the next year, revenue is expected to shrink by 41% compared to a 7.6% growth forecast for the 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 1% per year, which means it is significantly lagging earnings. Ankündigung • May 04
Opiant Pharmaceuticals, Inc. to Report Q1, 2022 Results on May 10, 2022 Opiant Pharmaceuticals, Inc. announced that they will report Q1, 2022 results After-Market on May 10, 2022 Ankündigung • Apr 28
Opiant Pharmaceuticals, Inc. Announces Positive Topline Results from Head-to-Head Pharmacodynamic Study Comparing OPNT003, Nasal Nalmefene, to Nasal Naloxone Opiant Pharmaceuticals, Inc. announced positive topline results from a pharmacodynamic (PD) study for OPNT003, nasal nalmefene, (3mg nalmefene hydrochloride), an investigational treatment for opioid overdose. This crossover study conducted in healthy volunteers compared 3 mg nasal nalmefene hydrochloride with 4 mg nasal naloxone hydrochloride in reversing respiratory depression produced by remifentanil, a synthetic opioid. The two study drugs were assessed by measuring changes in minute ventilation following administration of the respective study drug, with the primary endpoint at five minutes post administration. A preliminary analysis on the 50 subjects completing the study found that treatment with OPNT003, nasal nalmefene, produced a greater reversal of respiratory depression that was nearly twice that produced by nasal naloxone at five minutes. The increases in minute ventilation were 5.745 L/min and 3.011 L/min, with nalmefene and naloxone, respectively. OPNT003 met the primary endpoint of non-inferiority, which was designed to assess whether nasal nalmefene performed as well or better than nasal naloxone. Positive results were previously reported in two separate pharmacokinetic (PK) studies. OPNT003-PK-001 evaluated the PK behavior of nasal nalmefene compared to nalmefene intramuscular injection. Nasal nalmefene exhibited both rapid absorption (Tmax 15 min) and high plasma concentrations (Cmax 12.2 ng/ml) that surpassed an approved dose of intramuscular nalmefene, as well as having a comparable long plasma half-life. OPNT003-PK-002 compared the effect of a single dose of nasal nalmefene in one nostril, one dose in each nostril, and two doses in one nostril. OPNT003 demonstrated dose proportional plasma concentrations to a single dose, whether administered as a single dose in each nostril or as two doses in a single nostril, and was safe and well tolerated. Completion of the PD study concludes the planned clinical development program for OPNT003. OPNT003, nasal nalmefene, is being developed using a 505(b)(2) pathway. The U.S. Food and Drug Administration (FDA) granted Opiant Fast Track Designation for OPNT003 in November 2021. The Company expects to complete an NDA filing in the second half of 2022. Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. 2 highly experienced directors. Independent Chairman Craig Collard was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Ankündigung • Apr 19
Opiant Pharmaceuticals, Inc., Annual General Meeting, Jun 14, 2022 Opiant Pharmaceuticals, Inc., Annual General Meeting, Jun 14, 2022, at 09:00 Pacific Daylight. Location: 233 Wilshire Blvd., Suite 400 Santa Monica California United States Agenda: To elect two Class II directors to serve until the 2025 Annual Meeting or until their respective successors are elected and qualified; to ratify the appointment of MaloneBailey, LLP as the Company's independent auditors to audit the Company's financial statements for the fiscal year ending December 31, 2022; to hold an advisory vote to approve the compensation of our named executive officers; and to consider and act upon any other business as may properly come before the Annual Meeting or any adjournments thereof. Valuation Update With 7 Day Price Move • Apr 18
Investor sentiment improved over the past week After last week's 16% share price gain to US$22.66, the stock trades at a trailing P/E ratio of 38.2x. Average forward P/E is 13x in the Pharmaceuticals industry in the US. Total returns to shareholders of 86% over the past three years. Reported Earnings • Mar 18
Full year 2021 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2021 results: EPS: US$0.68 (up from US$0.44 loss in FY 2020). Revenue: US$47.8m (up 61% from FY 2020). Net income: US$3.01m (up US$4.87m from FY 2020). Profit margin: 6.3% (up from net loss in FY 2020). The move to profitability was driven by higher revenue. Revenue exceeded analyst estimates by 1.2%. Earnings per share (EPS) missed analyst estimates by 9.5%. Over the next year, revenue is expected to shrink by 47% compared to a 17% growth forecast for the pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 77% per year but the company’s share price has only increased by 23% per year, which means it is significantly lagging earnings growth. Valuation Update With 7 Day Price Move • Feb 25
Investor sentiment deteriorated over the past week After last week's 16% share price decline to US$26.27, the stock trades at a trailing P/E ratio of 78.9x. Average forward P/E is 17x in the Pharmaceuticals industry in the US. Total returns to shareholders of 72% over the past three years. Recent Insider Transactions • Jan 28
President recently sold US$52k worth of stock On the 27th of January, Roger Crystal sold around 2k shares on-market at roughly US$26.15 per share. This was the largest sale by an insider in the last 3 months. Roger has been a seller over the last 12 months, reducing personal holdings by US$82k. Ankündigung • Jan 22
Opiant Pharmaceuticals, Inc. Announces First Patient Dosed in Phase 2 Trial of Opnt002 Opiant Pharmaceuticals, Inc. announced that the first patient has been dosed in a Phase 2 clinical trial of OPNT002, nasal naltrexone, for the treatment of Alcohol Use Disorder (“AUD”). The trial will determine whether OPNT002 reduces heavy drinking as measured by a change in the World Health Organization (“WHO”) drinking risk levels. Clinical and preclinical studies have shown that alcohol releases endorphins, which are the brain’s endogenous opioids. These endorphins are thought to activate opioid receptors, which contribute to alcohol’s reinforcing and addictive properties. Current naltrexone treatments work to block mu-opioid receptors when administered orally or through injection. However, converging lines of evidence indicate that activation of delta-opioid receptors also contributes to the reinforcing properties of alcohol. The effective blockade of delta-opioid receptors requires much higher plasma naltrexone concentrations than is achieved by currently approved naltrexone products. Opiant is developing OPNT002 to rapidly increase plasma concentrations of the drug following dosing and thereby block mu and delta-opioid receptors. In previous research, OPNT002 has demonstrated rapid nasal absorption, delivering high levels of naltrexone yet with a short half-life. Results from Phase 1 studies demonstrate that OPNT002 produces maximum plasma concentrations that are approximately 50% higher than orally administered naltrexone. This feature, along with a very rapid onset and a short plasma half-life, are characteristics ideally suited to developing OPNT002 for ‘as needed’ nasal dosing in anticipation of drinking, or once drinking has started2,3. The primary end point will be the proportion of subjects showing an improvement in WHO Drinking Risk Level consisting of a 2-level reduction from Baseline to end of treatment. WHO Drinking Risk Level will be evaluated in the 28 days prior to the Baseline and end of treatment visits. The trial is a randomized, double-blind, placebo-controlled study that will enroll approximately 300 patients at sites within the European Union and the United Kingdom. The trial features a Sequential Parallel Comparison Study Design (“SPCD”) aiming to reduce placebo response. Results from the trial are expected in 2023. Valuation Update With 7 Day Price Move • Jan 19
Investor sentiment deteriorated over the past week After last week's 15% share price decline to US$25.97, the stock trades at a trailing P/E ratio of 78x. Average forward P/E is 16x in the Pharmaceuticals industry in the US. Total returns to shareholders of 81% over the past three years. Board Change • Dec 06
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. 2 highly experienced directors. Independent Chairman Craig Collard was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Valuation Update With 7 Day Price Move • Nov 19
Investor sentiment deteriorated over the past week After last week's 15% share price decline to US$24.03, the stock trades at a trailing P/E ratio of 72.2x. Average forward P/E is 16x in the Pharmaceuticals industry in the US. Total returns to shareholders of 54% over the past three years. Reported Earnings • Nov 13
Third quarter 2021 earnings released: EPS US$0.77 (vs US$0.17 in 3Q 2020) The company reported a strong third quarter result with improved earnings, revenues and profit margins. Third quarter 2021 results: Revenue: US$16.3m (up 79% from 3Q 2020). Net income: US$3.42m (up 371% from 3Q 2020). Profit margin: 21% (up from 8.0% in 3Q 2020). The increase in margin was driven by higher revenue. Over the last 3 years on average, earnings per share has increased by 70% per year but the company’s share price has only increased by 18% per year, which means it is significantly lagging earnings growth. Recent Insider Transactions • Sep 15
Independent Chairman recently bought US$174k worth of stock On the 10th of September, Craig Collard bought around 10k shares on-market at roughly US$18.18 per share. This was the largest purchase by an insider in the last 3 months. This was Craig's only on-market trade for the last 12 months. Recent Insider Transactions Derivative • Aug 27
Independent Director exercised options and sold US$1.6m worth of stock On the 25th of August, Michael Sinclair exercised 150k options at a strike price of around US$5.00 and sold these shares for an average price of US$15.71 per share. This trade did not impact their existing holding. Since June 2021, Michael has owned 110.17k shares directly. Company insiders have collectively sold US$1.4m more than they bought, via options and on-market transactions in the last 12 months. Reported Earnings • Aug 09
Second quarter 2021 earnings released: EPS US$0.39 (vs US$0.051 loss in 2Q 2020) The company reported a strong second quarter result with improved earnings, revenues and profit margins. Second quarter 2021 results: Revenue: US$11.3m (up 78% from 2Q 2020). Net income: US$1.68m (up US$1.90m from 2Q 2020). Profit margin: 15% (up from net loss in 2Q 2020). The move to profitability was driven by higher revenue. Over the last 3 years on average, earnings per share has increased by 68% per year but the company’s share price has remained flat, which means it is significantly lagging earnings. Major Estimate Revision • Aug 06
Consensus revenue estimates increase to US$37.0m The consensus outlook for revenues in 2021 has improved. 2021 revenue forecast increased from US$33.6m to US$37.0m. Forecast losses expected to reduce from -US$1.93 to -US$0.63 per share. Pharmaceuticals industry in the US expected to see average net income growth of 13% next year. Consensus price target of US$41.33 unchanged from last update. Share price was steady at US$16.15 over the past week. Ankündigung • Jun 28
Opiant Pharmaceuticals, Inc.(NasdaqCM:OPNT) dropped from Russell 3000E Value Index Opiant Pharmaceuticals, Inc.(NasdaqCM:OPNT) dropped from Russell 3000E Value Index Reported Earnings • May 12
First quarter 2021 earnings released: US$0.66 loss per share (vs US$0.40 loss in 1Q 2020) The company reported a mediocre first quarter result with increased losses and weaker control over costs, although revenues improved. First quarter 2021 results: Revenue: US$6.39m (up 49% from 1Q 2020). Net loss: US$2.84m (loss widened 69% from 1Q 2020). Over the last 3 years on average, earnings per share has increased by 65% per year but the company’s share price has fallen by 8% per year, which means it is significantly lagging earnings. Ankündigung • May 12
Opiant Pharmaceuticals, Inc. Provides Earnings Guidance for the Full Year 2021 Opiant Pharmaceuticals, Inc. provided earnings guidance for the full year 2021. Based on the mid-range of the full-year 2021 guidance for sales of NARCAN Nasal Spray provided by EBS, of $315 million, the company continues to expect full-year 2021 royalty revenue from the sale of NARCAN Nasal Spray of approximately $27.8 million. Recent Insider Transactions Derivative • Mar 11
Independent Director exercised options to buy US$101k worth of stock. On the 5th of March, Gabrielle Silver exercised options to buy 8k shares at a strike price of around US$10.00, costing a total of US$83k. This transaction amounted to 185% of their direct individual holding at the time of the trade. Since June 2020, Gabrielle has owned 4.52k shares directly. Company insiders have collectively bought US$223k more than they sold, via options and on-market transactions, in the last 12 months. Major Estimate Revision • Mar 11
Analysts update estimates The 2021 consensus revenue estimate increased from US$25.7m to US$32.1m. Earning per share (EPS) estimate was further reduced from -US$1.94 to -US$2.06 for the same period. The Pharmaceuticals industry in the US is expected to see an average net income growth of 11% next year. The consensus price target of US$41.33 was unchanged from the last update. Share price is down by 12% to US$12.11 over the past week. Reported Earnings • Mar 06
Full year 2020 earnings released: US$0.44 loss per share (vs US$2.89 profit in FY 2019) The company reported a poor full year result with weaker earnings, revenues and control over costs. Full year 2020 results: Revenue: US$29.6m (down 27% from FY 2019). Net loss: US$1.86m (down 116% from profit in FY 2019). Over the last 3 years on average, earnings per share has increased by 48% per year but the company’s share price has fallen by 15% per year, which means it is significantly lagging earnings. Analyst Estimate Surprise Post Earnings • Mar 06
Revenue and earnings beat expectations Revenue exceeded analyst estimates by 2.5%. Earnings per share (EPS) also surpassed analyst estimates by 97%. Over the next year, revenue is expected to shrink by 13% compared to a 23% growth forecast for the Pharmaceuticals industry in the US. Ankündigung • Feb 23
Opiant Pharmaceuticals, Inc. to Report Q4, 2020 Results on Mar 04, 2021 Opiant Pharmaceuticals, Inc. announced that they will report Q4, 2020 results After-Market on Mar 04, 2021 Recent Insider Transactions Derivative • Feb 18
Independent Director exercised options to buy US$97k worth of stock. On the 11th of February, Ann MacDougall exercised options to buy 7k shares at a strike price of around US$10.00, costing a total of US$70k. This transaction amounted to 70% of their direct individual holding at the time of the trade. Since June 2020, Ann has owned 10.00k shares directly. Company insiders have collectively bought US$140k more than they sold, via options and on-market transactions, in the last 12 months. Ankündigung • Feb 09
Opiant Pharmaceuticals Announces First Patient Dosed in Confirmatory Pharmacokinetic Study Assessing OPNT003, Nasal Nalmefene, for the Treatment of Opioid Overdose Opiant Pharmaceuticals, Inc. announced the dosing of the first patient in a confirmatory pharmacokinetic (“PK”) study for OPNT003, nasal nalmefene, for the treatment of opioid overdose. Results from the study are anticipated June 2021. Deaths resulting from opioid overdose are at record levels, driven in large part by high-potency synthetic opioids, such as fentanyl. In 2017, the National Institutes of Health’s (“NIH”) leadership called for longer lasting and stronger opioid overdose reversal agents in response to this escalating public health crisis. The open label, randomized, crossover study will enroll 68 healthy volunteers and determine the pharmacokinetic profile of intranasally administered nalmefene compared to intramuscularly administered nalmefene. Opiant also intends to conduct a separate pharmacodynamic study in healthy volunteers later this year. The development of OPNT003 is supported by grants from the National Institute on Drug Abuse (“NIDA”), part of the NIH, and the Biological Advance Research and Development Agency (“BARDA”). The Company plans to file a 505(b)(2) New Drug Application for OPNT003 with the U.S. Food and Drug Administration by the end of 2021. Is New 90 Day High Low • Feb 06
New 90-day high: US$12.96 The company is up 83% from its price of US$7.10 on 06 November 2020. The American market is up 15% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 10.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$253 per share. Ankündigung • Jan 22
Opiant Pharmaceuticals, Inc. Appoints Craig A. Collard to the Compensation Committee of the Board Opiant Pharmaceuticals, Inc. previously announced the appointment of Craig A. Collard to Chairman of the company's Board of Directors, effective January 1, 2021. In addition, on January 14, 2021, the Board appointed Dr. Gabrielle Silver to the Compensation Committee of the Board. Is New 90 Day High Low • Jan 20
New 90-day high: US$9.29 The company is up 25% from its price of US$7.41 on 21 October 2020. The American market is up 13% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 11% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$253 per share. Ankündigung • Dec 16
Opiant Pharmaceuticals Announces Additional $3.5 Million Funding Under BARDA Contract for OPNT003 Nasal Nalmefene Development Program Opiant Pharmaceuticals, Inc. announced an additional commitment of up to $3.5 million from the Biomedical Advanced Research and Development Authority (“BARDA”), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to advance the clinical development of OPNT003, nasal nalmefene, for opioid overdose. The contract modification increases the total potential value of the BARDA contract to $8.1 million. An earlier award from BARDA for up to $4.6 million, combined with a $7.4 million grant Opiant received from the National Institute on Drug Abuse (“NIDA”), also supports the clinical development and U.S. regulatory submission of OPNT003. The additional BARDA support will fund both a planned pharmacodynamic study in healthy volunteers and development work associated with the use of Aptar Pharma’s Unit Dose System. Opioid overdose is a significant public health crisis that has been exacerbated by the increased availability and abuse of synthetic opioids, such as fentanyl. Fentanyl is 50-fold more potent than heroin, far easier and less expensive to produce, and has a significantly longer half-life. Fentanyl and related synthetic opioids were linked to more than 75% of the nearly 51,000 opioid overdose deaths in 2019 in the U.S. The contract with BARDA allows for development of OPNT003 as a medical countermeasure in a chemical attack using synthetic opioids. Ankündigung • Dec 10
Opiant Pharmaceuticals Announces Appointment of Craig A. Collard as Chairman to Its Board of Directors Opiant Pharmaceuticals, Inc. announced the appointment of Craig A. Collard, a seasoned biopharmaceutical leader with over 20 years of commercial and executive experience, to Chairman of its Board of Directors, effective January 1, 2021. Mr. Collard joined the Opiant board in 2018. Gabrielle Silver, M.D., who has served as Lead Independent Director since October, 2018, will remain an independent director on the Board and continue to be Chairman of the Nominating and Governance Committee. Major Estimate Revision • Nov 19
Analysts increase EPS estimates to -US$0.20 The 2020 consensus revenue estimate increased from US$27.4m to US$28.9m. Analysts raised their EPS forecasts from -US$0.83 to -US$0.20 in 2020. The Pharmaceuticals industry in the US is expected to see an average net income growth of 3.6% next year. The consensus price target of US$41.33 was unchanged from the last update. Share price is up 9.3% to US$7.98 over the past week. Analyst Estimate Surprise Post Earnings • Nov 17
Revenue and earnings beat expectations Revenue exceeded analyst estimates by 17%. Earnings per share (EPS) also surpassed analyst estimates. Over the next year, revenue is expected to shrink by 3.5% compared to a 21% growth forecast for the Pharmaceuticals industry in the US. Reported Earnings • Nov 14
Third quarter 2020 earnings released: EPS US$0.17 The company reported a poor third quarter result with weaker earnings, revenues and profit margins. Third quarter 2020 results: Revenue: US$9.11m (down 56% from 3Q 2019). Net income: US$725.0k (down 93% from 3Q 2019). Profit margin: 8.0% (down from 52% in 3Q 2019). The decrease in margin was driven by lower revenue. Over the last 3 years on average, earnings per share has increased by 38% per year but the company’s share price has fallen by 37% per year, which means it is significantly lagging earnings. Analyst Estimate Surprise Post Earnings • Nov 14
Revenue and earnings beat expectations Revenue exceeded analyst estimates by 17%. Earnings per share (EPS) also surpassed analyst estimates. Over the next year, revenue is forecast to grow 17%, compared to a 20% growth forecast for the Pharmaceuticals industry in the US. Ankündigung • Nov 13
Opiant Pharmaceuticals, Inc. Updates Revenue Guidance for the Year 2020 Opiant Pharmaceuticals, Inc. updated revenue guidance for the year 2020. For the year, the company expects updated revenue guidance for NARCAN®sales of between $295 million and $315 million. Based on this the company have increased projection of royalty revenue for the full year from $26.2 to approximately $28 million. Ankündigung • Oct 30
Opiant Pharmaceuticals Partners with Aptar Pharma for Nasal Nalmefene Opioid Overdose Treatment Opiant Pharmaceuticals, Inc. announced it has entered into an agreement with drug delivery specialist Aptar Pharma (“Aptar”), for the development of OPNT003 nasal nalmefene for use in conjunction with Aptar’s Unit Dose System (UDS) for the treatment of opioid overdose. The Aptar UDS has been approved by the U.S. Food and Drug Administration (FDA) with multiple drug products marketed in the United States, including internally developed and licensed NARCAN® Nasal Spray. Ankündigung • Oct 28
Opiant Pharmaceuticals, Inc. to Report Q3, 2020 Results on Nov 12, 2020 Opiant Pharmaceuticals, Inc. announced that they will report Q3, 2020 results at 5:00 PM, Eastern Standard Time on Nov 12, 2020 Is New 90 Day High Low • Oct 22
New 90-day low: US$7.41 The company is down 19% from its price of US$9.15 on 24 July 2020. The American market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 1.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$158 per share. Is New 90 Day High Low • Sep 30
New 90-day low: US$7.60 The company is down 17% from its price of US$9.13 on 02 July 2020. The American market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$158 per share. Ankündigung • Jul 24
Opiant Pharmaceuticals, Inc. to Report Q2, 2020 Results on Aug 06, 2020 Opiant Pharmaceuticals, Inc. announced that they will report Q2, 2020 results at 5:00 PM, Eastern Standard Time on Aug 06, 2020 