Harrow, Inc. · NASDAQ:HROW
Harrow — Harrow Health — Investor Presentation (September 2019)
18 slides from Harrow's investor presentation, Sep 12, 2019
Slide 1: Melt Pharmaceuticals Corporate Presentation
PHARMACEUTICALS MELT PHARMACEUTICALS | CORPORATE PRESENTATION Innovation and aot Paradigm in Conscious Sedation and Analgesia oe: >? JULY 2019
Slide 2: Safe Harbor
melt Safe Harbor This presentation contains express “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. You are cautioned not to rely on these forward-looking statements which involve substantial risks and uncertainties. These statements are based on curr
Slide 3: To create a new class of patient centric medications
To create a new class of patient centric medications used in sedation and analgesia through the development on non-opioid, non intravenous therapeutics
Slide 4: Overview
melt Overview Two programs: a sublingual formulation of midazolam for conscious sedation and a sublingual, non-opioid combination of midazolam and ketamine for conscious sedation and analgesia ° Large and growing initial market ¢ Accelerated clinical and regulatory opportunity, currently 4.4 million
Slide 5: Melt-200
Melt-200 Sublingual, rapidly dissolving tablet containing 3 mg of midazolam + We utilize a patented fast dissolving technology, that allows the tablet to dissolve in the patients mouth in less than ten seconds Likelihood of condensed clinical program leading to NDA filing in near-term Significant Co
Slide 6: Melt-100
melt Melt-100 Sublingual, rapidly dissolving tablet containing 3 mg of midazolam and 25 mg of ketamine We utilize a patented fast dissolving technology, that allows the tablet to dissolve in the patients mouth in less than ten seconds Significant Competitive Advantages: » Established safety profile,
Slide 7: Two well established and known medications
melt Two well established and known medications Midazolam Ketamine * Midazolam is an FDA approved benzodiazepine, * Ketamine is an FDA approved anesthetic, and was first and was first introduced in the U.S. market in 1997 introduced in the U.S. market in 1970 * Midazolam is commonly utilized for con
Slide 8: Clinical and Regulatory Strategy
Clinical and Regulatory Strategy Melt-200 + Indication for conscious sedation during cataract and/or ocular surgery + Condensed clinical program using 505(b)2 regulatory pathway allows for NDA filing in near-term. + Advisory and expert feedback indicate likely clinical pathway includes + Phase 1 PK/
Slide 9: Clinical and Regulatory Strategy
melt Clinical and Regulatory Strategy Melt-100 - Lifecycle Management as next generation advancement of Melt-200 Two pathways: 1. Indication for conscious sedation and analgesia during cataract and/or ocular surgery 2. Indication for analgesia only during cataract and/or ocular surgeries + Successfu
Slide 10: Clinical and Regulatory Timelines
Clinical and Regulatory Timelines File IND NDA MELT-200 * x Phase1 _Registrational PK/BA study study File IND NDA Non- Phase 1 ‘ ji ies ——> ELT-100 clinical/tox PK/BA — a studies study O-O ls + O + « s Op Ma @G MO sD Q3‘19 Q1‘20 Q421 Qi ‘22 Qi ‘23 Qi ‘24
Slide 11: Opportunity for accelerated commercial launch and revenues
melt Opportunity for accelerated commercial launch and revenues - Upon approval, opportunity to rapidly transition clinicians using MKO Melt over to new FDA approved Melt 200 providing accelerated launch and near-term revenues + Nearly 100,000 units of MKO Melt (with ondansetron) have been produced
Slide 12: Favorable Reimbursement Environment
Favorable Reimbursement Environment Opportunity to be granted transitional pass-through reimbursement under Medicare Part B Eligibility for separate payment from Centers for Medicare & Medicaid Services (“CMS”) * designed to promote innovation and allows for separate payment (i.e., outside the packa
Slide 13: 2019 Policy Support from CMS...
melt 2019 Policy Support from CMS... Combating the Opioid Crisis In response to recommendations from the President’s Commission on Combatting Drug Addiction and the Opioid Crisis, out of an abundance of caution and to avoid any potential unintended consequences of possible opioid overprescribing In
Slide 14: Competition Background
Competition Background Most common classes of medications for conscious sedation in cataract surgery: * Benzodiazepines/Sedatives * Opioids and Analgesic agents + Combinations Most widely used products in conscious sedation for cataract surgery are IV midazolam alone or in combinations with other IV
Slide 15: Cataract Surgery market is large and growing
melt Cataract Surgery market is large and growing Initial indication: Cataract surgery is one of the most common procedures performed in the US 4.4 million cataract surgeries performed in 2017, growing at rate of ~3% per year IOL Surgical Procedures by Quarter 4,200 Cataract Procedures j= Other [OL
Slide 16: Numerous Market Expansion Opportunities
i melt PHARMACEUTICALS Numerous Market Expansion Opportunities *Short duration medical procedures requiring conscious sedation and/or analgesia TARGETED PROCEDURES Annual Procedures (US) a Endoscopic 18,500,000 1. US Market Report Suite for Gastrointestinal Endoscopic Devices 2017- MedSute. (2035 Au
Slide 17: Experienced Leadership
melt Experienced Leadership Greg Madison, Chief Executive Officer: is a 30 year pharmaceutical industry veteran, most recently as CEO of Keryx Biopharmaceuticals, a commercial stage company where he oversaw the buildout of the company in preparation for their first product approval. Prior to this, h
Slide 18: Summary
melt Summary Significant opportunity to leverage platform of novel sub-lingual formulations providing a non-opioid and non-lV solution for conscious sedation and analgesia + Unique drugs with potential competitive advantages (sublingual, non-opioid, IV free) + Cataract/ocular surgery Initial indicat
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