Harrow, Inc. · NASDAQ:HROW
Harrow — Imprimis Pharmaceuticals — Investor Presentation (July 2013)
39 slides from Harrow's investor presentation, Jul 23, 2013
Slide 1: A Unique Approach to 505(b)(2)
Imprimis Pharmaceuticals, Inc. “A Unique Approach to 505(b)(2)” July 2013 Mark L. Baum, C.E.O.
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains "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. These statements are based on current expectations of future events. If underlying assu
Slide 3: Imprimis Overview
Imprimis Overview © Imprimis Pharmaceuticals, Inc. | *
Slide 4: Imprimis Snapshot
Imprimis Snapshot © Imprimis Pharmaceuticals, Inc. | * • Approx. $19.0M in cash as of 03/31/13 • Nominal debt; no preferred instruments • Phase 3 topical NSAID pivotal to start in Q3 2013 • Exclusive commercial rights to PCCA development IP • 10,000+ drug formulations • 10+ drug delivery technologie
Slide 5: Imprimis Overview
Imprimis Overview © Imprimis Pharmaceuticals, Inc. | * Low Risk Low Margin 505(b)(2) … Lower Risk | Higher Margin Our mission is to develop proprietary drugs using the FDA 505(b)(2) drug development pathway
Slide 6: 505(b)(1) NDA vs 505(b)(2) NDA vs 505(j) ANDA
Application 505(b)(1) NDA 505(b)(2) NDA 505(j) ANDA New Chemical Entity (NCE) Yes Yes/No (Rely on RLD and Prior Investigation) No (RLD is off patent) New Indication Yes Yes No New Form/Dose Yes Yes No Required Data for Approval • Complete Pharmacology • Complete Preclinical Safety, including long te
Slide 7: Imprimis Development Model
1% 99% Imprimis Development Model © Imprimis Pharmaceuticals, Inc. | * Imprimis Brings Innovation from Pharmaceutical Compounders to the >$300B U.S. Pharmaceutical Industry Pharmaceutical Compounders
Slide 8: PCCA Strategic Relationship
PCCA Strategic Relationship • Professional Compounding Centers of America (PCCA) is the largest compounding pharmacy organization in North America 1. Supply chemicals, equipment, accredited training, software, and business/pharmacy consulting assistance • Over 4,000 pharmacy businesses/chains worldw
Slide 9: Imprimis Vision
Imprimis Vision © Imprimis Pharmaceuticals, Inc. | * Drive Shareholder Value • Monetize vast 505(b)(2) development assets • Selectively internal development • Partner • Out-license Improve Patient Care • Novel drug administration • Reduce or eliminate negative side effect profiles • Increase therape
Slide 10: Monetizing the PCCA Relationship
Internally Develop Partner, Out-License Monetizing the PCCA Relationship Step 1: Opportunity Matrix X-Axis: Drug Administration • Competition • Reimbursement Landscape • Dollar Size • Number of Annual RX
Slide 11: Imprimis Growth & Development Process
Candidate Imprimis Growth & Development Process Ideas Candidates Projects • Market Data • Drug Master File • Field Experience • Out-License or Develop • Complete Phase 3 • NDA via 505(b)(2) • Market Launch/Partner NDA & LAUNCH
Slide 12: Imprimis Pipeline
Imprimis Pipeline © Imprimis Pharmaceuticals, Inc. | *
Slide 13: Pipeline by Therapeutic Area and Indication
Therapeutic Area Compound Indication Market Analysis PAIN IPI110 Impracor™, Ketoprofen 10% Cream Sprains, Strains and Joint Pain $10B US NSAID Market Transitioning to Topicals due to high incidence of AEs Voltaren Gel has 75% Rx Share Topical NSAID market may exceed $1B by 2015 OPHTHALMOLOGY IPI004*
Slide 14: Improving Patient Care: Impracor Phase 3 Topical NSAID
Improving Patient Care: Impracor ™ Phase 3 Topical NSAID © Imprimis Pharmaceuticals, Inc. | *
Slide 15: The Topical NSAID Market
The Topical NSAID Market © Imprimis Pharmaceuticals, Inc. | 15
Slide 16: The Case for Impracor
Factor Impracor™ Voltaren ® Delivery Technology Patented Accudel™ Micelles None; Alcohol API 10% Ketoprofen 1% Diclofenac COX Selectivity Cox 1 Cox 2 Smell Neutral Insect Repellant Tactile Smooth Greasy The Case for Impracor ™ © Imprimis Pharmaceuticals, Inc. | * • Market Analysis: • The $10B+ US NS
Slide 17: Impracor Phase 3 Program
Impracor ™ Phase 3 Program Initial Phase 3 Trial • mITT analysis: p=0.038 • Per protocol analysis: p=0.034 New Acute Pain Clinical Trials to Achieve FDA Approval • Two adequate/well controlled acute pain trials (one in label) • Leading pain trial experts have designed protocol • Use proprietary tool
Slide 18: Executive Team and Select Financial Data
Executive Team and Select Financial Data © Imprimis Pharmaceuticals, Inc. | *
Slide 19: Management Team Snapshot
Management Team Snapshot Strong operational and management experience within our leadership group Compensation weighted in equity Chief Executive Officer: Mark L. Baum, J.D. 15+ Years of Senior Executive Experience; Founder/President , YesRx.com (1999) Founder of 3 private investment funds; Restruct
Slide 20: Clinical and Regulatory Team Snapshot
Clinical and Regulatory Team Snapshot Senior Regulatory Advisor : Lee S. Simon, M.D. FDA Division Director of Analgesic, Anti-Inflammatory & Ophthalmologic Drug Products (2001-2003) Served on multiple FDA advisory committees; 12 years as an NIH funded investigator Senior consultant to Pharmacia/Sear
Slide 21: Capital Structure
Capital Structure March 31, 2013 (Unaudited) Percent Common Shares 8,888,250 82.72% Total Restricted Stock Units 200,000 1.86% Total Options & Warrants - Weighted Avg. Ex. Price $5.42 1,656,258 15.42% Total Common Shares - Diluted 10,744,508 100.00% Capital Structure © Imprimis Pharmaceuticals, Inc.
Slide 22: Summary
Summary © Imprimis Pharmaceuticals, Inc. | * • Imprimis is a Company with Vision • Unique Drug Development Model • Near Term Catalysts • Robust and Compelling Development Assets • Key Strategic Relationships • Cash Resources to Execute • Highly Capable Team
Slide 23: Questions & Discussion
Questions & Discussion Imprimis Pharmaceuticals, Inc. Delivering Safe, Effective and Direct Solutions FOR MORE INFORMATION CONTACT: Mark L. Baum, J.D. (858) 433-2816 - Direct mark@imprimispharma.com © Imprimis Pharmaceuticals, Inc. | *
Slide 24: Appendix - Investment Summary & Support
Appendix - Investment Summary & Support © Imprimis Pharmaceuticals, Inc. | A1
Slide 25: Accudel Topical Delivery Technology
Accudel ™ Topical Delivery Technology © Imprimis Pharmaceuticals, Inc. | A2
Slide 26: Introduction to Accudel
Introduction to Accudel ™ Pluronic Lecithin Organogel (PLO) Platform Lipophillic APIs Hydrophillic APIs Pluronic Phase Lecithin Phase • Accudel™ is a cream that “carries” drugs through the skin, penetrating to the problem site • Pluronic Lecithin Organogel (PLO) drug carrier • Accommodates different
Slide 27: In Vitro Penetration Data for Impracor
Introduction to Accudel ™ In Vitro Penetration Data for Impracor ™ and European Marketed Products (Fastum ® , Ketum ® , Oruvail ® ) • 63% - 70% of ketoprofen in Impracor that was available for release diffused through the membrane (0.45 m Nylon) of a Franz Cell Apparatus within 4 hours i . • (Fastum
Slide 28: Impracor Topical NSAID Competition and Market
Impracor ™ Topical NSAID Competition and Market © Imprimis Pharmaceuticals, Inc. | A5
Slide 29: Solution is to deliver NSAIDs topically to the site of pain
Solution is to deliver NSAIDs topically to the specific site of pain or inflammation The Problem With Oral NSAIDs Fact: Extremely Large Population Uses NSAIDs • 70 Million prescriptions for NSAIDs each year in US (Wiegard in Medscape) • Regularly used by more than 60M Americans (Arch Intern Med. 200
Slide 30: Competitive Landscape
Competitive Landscape 10% Ketoprofen Cream Proprietary Safe / Cutaneous Elegant Formulation Convenient / Cream Accudel Delivery System Local AEs 1-2% Seeking label sprains, strains, and joint pain IMPRACOR (Imprimis) 1.3% Diclofenac epolamine 10 x 14 cm patch 2 x per day Fixed one size patch Adheren
Slide 31: Ketoprofen vs. Ibuprofen
Ketoprofen vs. Ibuprofen “Meta-analysis of 26 trials (n=2,853) … showed that Ketoprofen was significantly better than all other topical NSAIDs. In terms of efficacy, Ketoprofen was significantly better than ibuprofen, felbinac, piroxicam and indomethacin.” Topical NSAIDs for acute pain: a meta-analy
Slide 32: Additional Impracor Clinical Materials
Additional Impracor ™ Clinical Materials © Imprimis Pharmaceuticals, Inc. | A9
Slide 33: Comparison of Topical NSAID Clinical Trials
Ketoprofen 20% Patch (ENDO) Ketoprofen Transfersome Gel, Diractin™ (IDEA) Diclofenac Solution Pennsaid™ (Nuvo) Phase 3 2/3 2 Study Dates Aug 2006 - May 2007 Jul 2003 - Jan 2004 Jul 2010 - Mar 2011 # of Subjects/ Age 309 / above 18 years 397/ above 40 years 248 / 18 -80 years Regimen/ Duration Ketopr
Slide 34: Initial Phase Trial Design and Study Population
Design: Randomized, double-blind, placebo-controlled at 26 sites Study Population: Efficacy, n = 361 Uncomplicated acute soft tissue injuries Ankle (n=97), Shoulder (n=87), Knee (n=59), Wrist (n=57), Elbow (n=30), Calf/Anterior Tibialis (n=11), Hamstring/Quadriceps (n=8), Forearm (n=5), Biceps/Trice
Slide 35: Safety: Low Incidence of Adverse Events
Safety: Low Incidence of Adverse Events * Clinical Study Report: TDLP-110-001, September 2010 ** Prescribing Information for Flector Patch, Voltaren Gel and Pennsaid Solution • No related gastrointestinal (GI), cardiac, liver, or other serious AEs • Low incidence of cutaneous AEs © Imprimis Pharmace
Slide 36: Pharmacokinetics: Low Systemic Absorption
Pharmacokinetics: Low Systemic Absorption * Cannavino, C. et al. Efficacy of Transdermal Ketoprofen in delayed onset muscular soreness,Clinical Journal of Sports Medicine, 13: 200-208, 2003 and Clinical Study Report Project No. 990808, Phase 1/2 Study Report Aug 2007 **Orudis ketoprofen extended rel
Slide 37: Additional Corporate Information
Additional Corporate Information © Imprimis Pharmaceuticals, Inc. | A14
Slide 38: Board of Directors
Board of Directors Robert J. Kammer, D.D.S. (Co-Founder) Active Clinical Research & Consulting Practice ; Diplomate, American Board of Orofacial Pain Retired Associate Professor & Course Director - Orofacial Pain, University of Colorado Mark L. Baum, J.D. (Co-Founder) 15+ Years of Senior Executive E
Slide 39: Balance Sheet
ASSETS March 31, 2013 Current Assets Cash and short term investments $ 19,029,031 Other assets 217,540 TOTAL ASSETS $ 19,246,579 LIABILITIES AND STOCKHOLDERS' EQUITY Accounts payable and other accruals $ 848,549 TOTAL LIABILITIES 848,549 Stockholder’s Equity Common stock, $0.001 par value, 395,000,0
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