Harrow, Inc. · NASDAQ:HROW
Harrow — Imprimis Pharmaceuticals — Investor Presentation (April 2013)
46 slides from Harrow's investor presentation, Apr 12, 2013
Slide 1: Imprimis Pharmaceuticals, Inc.
Imprimis Pharmaceuticals, Inc. “Positioned to Monetize One of the Largest Databases of Compounded Drug Formulations” April 2013 Mark L. Baum, C.E.O.
Slide 2: Safe Harbor Statement
Safe Harbor Statement The Company cautions you that the statements included in this presentation are not a description of historical facts and are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These
Slide 3: Imprimis Overview
Imprimis Overview © Imprimis Pharmaceuticals, Inc. | *
Slide 4: Imprimis Snapshot
Imprimis Snapshot © Imprimis Pharmaceuticals, Inc. | * • Approx. $19.5M in cash 1 • Nominal debt; no preferred instruments • Phase 3 topical NSAID pivotal to start mid 2013 • Exclusive commercial rights to PCCA development IP • 10,000+ drug formulations • 10+ drug delivery technologies • Vast market
Slide 5: Imprimis Overview
Imprimis Overview © Imprimis Pharmaceuticals, Inc. | * Low Risk Low Margin 505(b)(2) … Lower Risk | Higher Margin We develop proprietary drug assets using the 505(b)(2) 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 3,900 pharmacy businesses/chains worldw
Slide 9: Imprimis Vision
Imprimis Vision © Imprimis Pharmaceuticals, Inc. | * Drive Shareholder Value • Monetize vast PCCA IP and development assets • Selective internal development • Partner • Out-license Improve Patient Care • Novel drug administration • Reduce or eliminate negative side effect profiles • Increase therape
Slide 10: Internally Develop, Partner, Out-License
Internally Develop Partner, Out-License Monetizing the PCCA Relationship Step 1: Opportunity Matrix X Axis: Drug Administration Y Axis: Health Categories • Competition • Dollar Size • Number of Annual RX
Slide 11: Improving Patient Care: Impracor Phase 3 Topical NSAID
Improving Patient Care: Impracor ™ Phase 3 Topical NSAID © Imprimis Pharmaceuticals, Inc. | *
Slide 12: The Case for a Topical NSAID
Oral NSAIDs Topical NSAIDs Efficacy in Acute Soft Tissue Injuries Good Good Efficacy in Osteoarthritis Good Good Incidence of Adverse Events High Low GI Safety (Stomach) Poor Good Hepatic Safety (Liver) Poor Good Renal Safety (Kidney) Poor Good Cardiovascular Safety (Heart) Poor Good The Case for a
Slide 13: The Topical NSAID Market
The Topical NSAID Market © Imprimis Pharmaceuticals, Inc. | 13
Slide 14: The Case for Impracor
Factor Impracor™ Voltaren ® Delivery Technology Patented Accudel™ Micelles None; Alcohol Per Dose Quantity 3g 4g Dose Frequency BID (2X Daily) QID (4X Daily) API 10% Ketoprofen 1% Diclofenac COX Selectivity Cox 1 Cox 2 Smell Neutral Insect Repellant Tactile Smooth Greasy The Case for Impracor ™ © Im
Slide 15: Impracor Phase 3 Program
Impracor ™ Phase 3 Program Initial Phase 3 Trial • Removing subjects who should not have entered the trial: p=0.038 • Remove subjects who did not comply with the protocol: p=0.034 New Acute Pain Clinical Trials to Achieve FDA Approval • Two adequate and well controlled acute pain trials • Analgesic
Slide 16: Impracor Commercialization
Impracor ™ Commercialization • Capture existing compounded topical ketoprofen market • Doctors prefer FDA approved product • Patients prefer insurance reimbursement • Potentially more margin for pharmacies for FDA-approved product • Option to utilize PCCA member network to launch in US • Out-license
Slide 17: Impracor Intellectual Property
Impracor ™ Intellectual Property FDA Exclusivity • FDA protection with up to 3 years of new drug exclusivity • “Paragraph IV” claims can prevent generics for up to 30 months *** FDA “High Hurdles” for Topical Generics • Voltaren ™ - off exclusivity and off patent for years - no generics • There are
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 14, 2013 (Unaudited) Percent Common Shares 8,888,250 82.58% Total Restricted Stock Units 200,000 1.86% Total Options & Warrants - Weighted Avg. Ex. Price $5.49 1,675,487 15.56% Total Common Shares - Diluted 10,763,737 100.00% 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: Introduction to Accudel: In Vitro Penetration Data
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 1 gram 3 x per day = 3 grams/day Safe / Cutaneous Elegant Formulation Convenient / Cream Accudel Delivery System Local AEs 1-2% Seeking acute musculoskeletal pain label IMPRACOR (Imprimis) 1.3% Diclofenac epolamine 10 x 14 cm patch 2 x per day Fixed one siz
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: Relative COX-1/COX-2 Selectivity
Relative COX-1/COX-2 Selectivity Vane S J Thorax 2000;55:S3-S9 5-50 fold COX-2 selective <5-fold COX-2 selective -3 -2 -1 © Imprimis Pharmaceuticals, Inc. | A9
Slide 33: Additional Impracor Clinical Materials
Additional Impracor ™ Clinical Materials © Imprimis Pharmaceuticals, Inc. | A10
Slide 34: Comparison of Topical NSAID Clinical Studies
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 35: Retrospective Analysis of Phase 3 Study
Retrospective Analysis of 1 st Phase 3 Study p = 0.038 mITT ** (n=326) Study Design Error ITT * (n=361) Mean reduction from baseline in mm (100 mm Visual Analogue Scale) mm “Once randomized, you’re analyzed” p = 0.087 * ITT = Intent-to-treat (ITT) population ** mITT = Modified ITT of ITT patients -
Slide 36: Old Phase 3 Trial vs New Phase 3 Trial
Old Phase 3 Trial New Phase 3 Trial Many sprains and strains trials have failed • Acute OA flare (as a pain model) provides a more reliable population with better chance for separation High placebo responses • Utilize analgesia-specific proprietary implements and methodologies to identify placebo re
Slide 37: Phase 3 Study Design
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 38: 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 39: 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 40: Clear Separation of Data from Day 3 Onwards
Clear Separation of Data Day 4 Onwards Mean Change from Baseline in 3X/daily Pain Intensity Prior to Medication (from Patient Diary) All ITT patients (n=361) * =.statistically significant © Imprimis Pharmaceuticals, Inc. | A17 p = 0.041*
Slide 41: We Believe We Know What Body Part to Study
We Believe We Know What Body Part to Study Day 7 n=77 p=0.0396 Knees and Adjacent Muscle Injuries © Imprimis Pharmaceuticals, Inc. | A18 Average Change in Pain Intensity from Baseline
Slide 42: Phase 1/2 Study - Efficacy by Assessing DOMS
Phase 1/2 Study - Investigator IND Efficacy by Assessing DOMS 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 Time 0h 24h 48
Slide 43: Additional Corporate Information
Additional Corporate Information © Imprimis Pharmaceuticals, Inc. | A20
Slide 44: Board of Directors
Board of Directors Robert J. Kammer, D.D.S. Managing Member of financial group that restructured Imprimis Active Clinical Research & Consulting Practice 30+ Years Clinical Practice - Diplomate, American Board of Orofacial Pain Retired Associate Professor & Course Director - Orofacial Pain, Universit
Slide 45: Balance Sheet (Abbreviated)
ASSETS December 31, 2012 Current Assets Cash and cash equivalents $ 10,035,615 Other assets 670,381 TOTAL ASSETS $ 10,705,996 LIABILITIES AND STOCKHOLDERS' EQUITY Accounts payable and accrued expenses $ 709,559 TOTAL LIABILITIES 709,559 Stockholder’s Equity Common stock, $0.001 par value, 395,000,00
Slide 46: Imprimis Development Process
Candidate Imprimis 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
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