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Developing Medicines to Treat Addictions and Drug Overdose

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Developing Medicines to Treat Addictions and Drug Overdose Developing medicines to treat addictions and drug overdose NASDAQ: OPNT August 2021 Forward-Looking Statements This presentation contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” or “continue” or the negative of such terms and other comparable terminology. These forward-looking statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these forward-looking statements. Actual events or results may differ materially. In evaluating these forward-looking statements, you should specifically consider various factors. These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this presentation to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law. Page I 2 Opiant is leading a new wave of innovation in addiction and overdose Developed NARCAN® Nasal Spray, which is credited with reducing opioid overdose deaths. Our vision: Advancing investigational OPNT003 nasal nalmefene for opioid A world where addictions overdose – particularly well suited for synthetic opioids, incl. Fentanyl. are recognized as Robust pipeline in Opioid Overdose, Alcohol Use Disorder, Acute diseases of the brain and Cannabinoid Overdose, Opioid Use Disorder. treated like other chronic medical conditions. Financial support and collaboration of multiple U.S. government agencies including NIDA, BARDA. $48.5M cash and cash equivalents (June 30, 2021). $28.9M projected royalties from NARCAN® for the full-year 2021. Page I 3 Health burden of addiction and overdose are an urgent call to action Death rates from alcohol and drugs continue to climb -- and worsening during COVID-19 August 14, 2020 October 25, 2019 January 10, 2020 September 16, 2019 Source: Social Capital Project analyses of CDC data. Page I 4 Pipeline with a strategic focus to transform therapy in addiction and overdose Pre- FDA Indication Product Candidate / Regulatory Pathway Phase 1 Phase 2 Phase 3 NDA Partner clinical Approval Opioid Overdose NARCAN® Nasal Spray / 505(b)(2) OPNT003* Opioid Overdose Nalmefene Nasal Spray / 505(b)(2) OPNT002 Alcohol Use Opioid Antagonist Nasal Spray / Disorder 505(b)(2) Acute OPNT004** Cannabinoid Drinabant (CB-1 Antagonist) Overdose OPNT005 Opioid Use Heroin Vaccine: hapten + liposome Disorder adjuvant *OPNT003 has financial support from the National Institute on Drug Abuse (“NIDA”) and the Biomedical Advanced Research and Development Authority (“BARDA”) *Cooperative research and development agreement with the National Center for Advancing Translational Sciences (“NCATS”) to formulate OPNT004 for human studies in Acute Cannabinoid Overdose Page I 5 Accomplished leadership team combines extensive addiction, CNS drug development and commercial experience Roger Crystal, MD, MRCS, MBA CEO Phil Skolnick, PhD, DSc (hon) CSO David O’Toole, CPA CFO Mark Ellison, PhD Chief Development Officer Brian Gorman, JD EVP Corporate Development and General Counsel Matthew Ruth Chief Commercial Officer Page I 6 OPNT003 Nasal Nalmefene for Opioid Overdose Opioid overdose remains a public health crisis, dramatically heightened as synthetic opioids such as fentanyl drive up overdose deaths Number of opioid overdose deaths in the U.S. 80000 Phase 3: synthetic opioids 70000 Synthetic opioids such as fentanyl present in 60000 over three quarters of opioid overdose deaths 50000 40000 Phase 2: heroin 30000 20000 Heroin main driver of opioid overdose deaths 10000 Phase 1: painkillers 0 2015 2016 2017 2018 2019 2020 Opioid painkillers drive overdose deaths All opioids Synthetic opioids incl. fentanyl Heroin Rx opioids Provisional Data, CDC. Page I 8 Fentanyl leads wave of highly potent synthetic opioids, NIH calling for ‘stronger, longer-acting formulations of antagonists…’ Fentanyl: America’s new health crisis 2020 and beyond… • 50x stronger than heroin and cheaper • Longer duration of action than heroin (>7 hours vs. 1-2 hours) • Fentanyl and related compounds • Fentanyl analogues even stronger, e.g. carfentanil laced into other illicit drugs such as • Synthetic opioid surge is fueled by multiple sources cocaine – often without the user knowing • Greater presence of more potent opioids such as carfentanil • Fentanyl being made within the USA – ‘Breaking Bad’ Lethal amounts of • Growing concern over the use of heroin, fentanyl and ‘supercharged’ fentanyl in a chemical attack carfentanil 2018 Provisional Data, CDC. Source: NYT 7-17-19 Page I 9 Fentanyl’s potency can require multiple and continued doses of naloxone for rescue, creating an increasing drain on health-care resources across the U.S. Fentanyl overdose may require a more potent, faster onset, and longer-duration opiate antagonist than naloxone • Opioid antagonists compete with opioids for µ opioid receptors; a higher affinity at the mu opioid receptor favors a successful rescue • The plasma half-life of naloxone is 1 to 2 hours; fentanyl has a half-life of 7 to 8 hours – this longer duration can lead to subsequent overdose from renarcotization • The rapid onset of fentanyl shortens the window for a rescue , so a more rapid treatment onset favors a successful rescue Page I 10 OPNT003, nasal nalmefene: A potential solution to the evolving opioid overdose crisis Characteristics that make OPNT003 potentially superior OPNT003 Naloxone (3mg) (4mg) Increased affinity at the μ 1.01 5.41 opioid receptors Longer half-life 112 2.083 Faster rate of absorption 15 minutes2 30 minutes3 1 3 Ki values were estimated using [ H]alvimopan binding to cloned human m opioid receptors (Cassel, et al., 2005). The ~5-fold higher affinity of nalmefene compared to naloxone is consistent with both Ki values obtained (0.13 and 0.62 nM, respectively) 3 using [ H]DAMGO as a radioligand in monkey brain membranes (Emmerson, et al., 1994) and pA2 values of 9.38 and 8.51, respectively, in functional assays using guinea pig ileum and mouse vas deferens (Toll, et al., 1998). 2Data on file: NCT04759768 3 Data from FDA, 2015 (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf) Page I 11 Pharmacokinetic data of OPNT003 nasal nalmefene demonstrates rapid absorption and high concentration critical to a successful rescue 1 Confirmatory Pharmacokinetic Study 1 2 Nasal nalmefene achieved significantly higher plasma concentrations compared to injection (P<0.0001) • ~15 minutes to achieve maximum plasma concentrations (Tmax) • Maximum plasma concentration higher than 4 mg IN naloxone (Cmax) 1. 2Data on file: NCT04759768 2. Krieter P, Chiang N, Gyaw S, Skolnick P, Crystal R, Keegan F, Aker J, Beck M, Harris J. Pharmacokinetic Properties and Human Use Characteristics of an FDA-Approved Intranasal Naloxone Product for the Treatment of Opioid Overdose. J Clin Pharmacol. 2016 Oct;56(10):1243-53. doi: 10.1002/jcph.759. Epub 2016 Jun 10. PMID: 27145977. Page I 12 Pharmacodynamic study underway assessing OPNT003 compared to nasal naloxone in reversing respiratory depression produced by synthetic opioid • Two-part trial across ~56 healthy subjects studying the pharmacodynamic effects of nasal nalmefene compared to nasal naloxone • Primary Endpoint: Change in respiratory volume from opioid induced breathing suppression • Anticipate results in Q4 2021 ClinicalTrials.gov identifier (NCT number): NCT04828005; https://clinicaltrials.gov/ct2/show/NCT04828005?term=opiant&draw=2&rank=1 Page I 13 FDA has confirmed a 505(b)(2) pathway OPNT003, with key regulatory activities funded by NIDA and BARDA 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 2021 2021 2021 2021 2022 2022 2022 2022 Confirmatory PK PD NDA Potential Commercial Pharmacokinetic data data Filing for FDA launch (“PK”) study approval Pharmacodynamic (“PD”) study Note: timeline events based on Company’s expectations as of March 2020 Page I 14 Disciplined commercial approach can unlock significant value for OPNT003 driven by prevalence of opioid overdoses and substantial government funding Today: NARCAN® Nasal Spray sales projected at $325M in 2021, up from ~$25M in 20161 Target markets: Retail Funded by: Public Interest Sector OPNT003SAMSHA • Emergency medical services (EMS) • State Opioid Response and Block Grants • law enforcement (local and federal) • Significant added government support • Fire Departments • Possible proceeds from settlement • Community Retail Sector Payors Driven by co-prescribing legislation now • NARCAN® Nasal Spray minimal co-pay present in 12 states, and Pharmacy for almost all payors Standing Orders – in all states 1. Based on Adapt Pharma revenue (2016) and Emergent Biosolutions NARCAN® Nasal Spray expected net sales in 2021 Page I 15 OPNT002 Nasal
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