Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (January 2014)
26 slides from Lipocine's investor presentation, Jan 7, 2014
Slide 1: Corporate Presentation January 2014
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 Corporate Presentation January 2014 Exhibit 99.2
Slide 2: Forward-looking statements
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 2 This presentation contains and our discussions during this conference may include forward - looking statements about Lipocine Inc. (the “Company”). These forward - looking sta
Slide 3: Investment Highlights
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 3 ; Focused on developing innovative orally - available treatment alternatives in the areas of men’s and women’s health • Pipeline of well - known molecules with 505(b)(2) acces
Slide 4: Product Pipeline
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 4 LPCN 1021 - Oral Testosterone Replacement Therapy (TRT) Product Pipeline Men’s Health LPCN 1111 - Next Generation Oral TRT Women’s Health LPCN 1107 - Prevention of Preterm Bir
Slide 5: Lip'ral Enables Optimal Dispersion in the Gastrointestinal Tract
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 5 Lip’ral Enables Optimal Dispersion in the Gastrointestinal Tract Lumen Aqueous Barrier Layer Membrane Systemic Circulation Improved absorption Effective transfer across aqueou
Slide 6: Testosterone Replacement Therapy Market
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 6 ; >$2B market in 2012 ; Increased low testosterone (T) awareness driven by Abbott, Glaxo and Lilly promotion ; Inadequacy of existing testosterone treatments Testosterone Repl
Slide 7: LPCN 1021: Overview
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 7 ; Testosterone Undecanoate (TU, a prodrug of testosterone) oral composition designed for convenient BID dosing ; Primarily directed at lymphatic delivery ; Maintains effective
Slide 8: Successful Phase 2 Dose Finding Without Titration
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 8 Successful * Phase 2 Dose Finding Without Titration * See Appendix slides for Details % of subjects meeting criteria PK parameters LPCN 1021 225 mg BID Da y 15 (n=24) FDA crit
Slide 9: Phase 2 Study Safety Summary
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 9 ; No significant adverse events ; DHT/T and E2/T ratios observed with LPCN 1021 are in the normal range ; HDL changes with LPCN 1021 in the range of other approved TRT product
Slide 10: LPCN 1021: Phase 3 Design (SOAR)
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 10 ; Double - blind, randomized, active - controlled study of LPCN 1021 in men with low testosterone ; Primary endpoint: serum testosterone concentration at Week 13 LPCN 1021: P
Slide 11: Competitive Environment for Oral Testosterone
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 11 Competitive Environment for Oral Testosterone * See Appendix (Adult male BMI Distribution) CLR 610: Clarus Therapeutics Current Status • Phase 3 complete LPCN 1021 Advantages
Slide 12: LPCN 1111: Next Generation Oral Testosterone
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 12 ; Novel prodrug of testosterone for oral delivery through proprietary Lip’ral technology ; Designed to provide balance between adequate bioavailability and sustained daily te
Slide 13: Preterm Birth Represents a Significant Unmet Medical Need
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 13 ; Preterm birth (PTB) is defined as delivery less than 37 weeks of gestation ; 9.6% of all births (12.9 million) worldwide 1 ; 11.7% of all US pregnancies 2 result in PTB ; ≥
Slide 14: LPCN 1107: Oral Hydroxyprogesterone Caproate for Preterm Birth
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 14 ; Potential to be the first oral hydroxyprogesterone caproate (HPC) • API is an approved injectable drug for recurrent preterm birth • Elimination of injection site reaction
Slide 15: Significant Value Driving Milestones for LPCN 1021
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 15 ; First patient dosing in pivotal Phase 3 study – 1Q 2014 ; Top - line Phase 3 efficacy results for – 2H 2014 ; Complete Phase 3 data with safety data – 2H 2015 ; File NDA –
Slide 16: Experienced Management Team
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 16 ; Mahesh Patel, Ph.D.: President, CEO & Co - Founder • Director, Specialty products, Pharmacia and Upjohn ; Morgan Brown, CPA: Executive Vice President & CFO • CFO, Innovus P
Slide 17: Investment Highlights
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 17 ; Focused on developing innovative orally - available treatment alternatives in the areas of men’s and women’s health • Pipeline of well - known molecules with 505(b)(2) acce
Slide 18: Appendix
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 Appendix
Slide 19: Food Effect Study
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 19 ; Single dose, open label, five treatment (diet) period cross over study in ten subjects* • 75 mg testosterone undecanoate capsule • Five conditions : fasting and four meals
Slide 20: Examples of Items Providing Required Fat Calories Per Meal
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 20 8g 19g 22g 20g 22g 22g 26g 19g 27g Whole milk, 8 fl. oz. French toast, 2 slices w/ butter Muffin (4 oz) commercially prepared Cinnamon roll Pancakes (various) Trail mix, ½ cu
Slide 21: Distribution of BMI Among US Adult Males
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 21 Distribution of BMI Among US Adult Males Source: JAMA, February 1, 2012; Vol 307, No. 5, pp491 - 497; Prevalence of Obesity and Trends in the Distribution of Body Mass Ind ex
Slide 22: LPCN 1107: $2.2 Billion Annual Savings Impact of Preventing Recurrent PTB
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 22 ; Annually 180,000 1 Pregnancies are Eligible (Prior PTB History) for HPC Treatment ; Based on Efficacy Results 2 at Least 35,000 Eligible Patients are Expected to Benefit fr
Slide 23: LPCN 1021: Phase 2 Design
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 23 Group Dose (mg) Study Duration Number of Subjects Completed Sampling Time LPCN 1021 Placebo 1 75 15 Days 16 3 Full PK profile : Day ‘ - 1’, 1, 8 and 15 Pre - dose C min sampl
Slide 24: LPCN 1021: Phase II Testosterone Results
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 24 PK Parameters Criteria / Target 75mg 150mg 225mg* 300mg N UMBER OF SUBJECTS 16 15 24 9 P RIMARY E ND P OINTS % of Subjects meeting the criteria on Day 15 C ave, 0 - 24h 300 -
Slide 25: Correlation between Primary and Secondary End Points
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 25 0 300 600 900 1200 1500 1800 2100 2400 2700 3000 3300 3600 0 100 200 300 400 500 600 700 800 900 1000 1100 1200 Secondary End Point [C max (ng/dL )] Primary End Point [C ave0
Slide 26: LPCN 1021: Phase II Adverse Event Profile
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 26 LPCN 1021: Phase II Adverse Event Profile System organ class preferred term Groups 1 - 3 Groups 4 & 5 Placebo Group 1, 75 mg Group 2, 150 mg Group 3, 225 mg Placebo Group 5,