Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (February 2014)
30 slides from Lipocine's investor presentation, Feb 10, 2014
Slide 1: Corporate Presentation February 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 February 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: Lipocine 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) strategy
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 Deficiency is Prevalent in U.S.
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 Testosterone Deficiency is Prevalent in U.S. 1 (1) Rev. Urol Vol 5. Suppl 1 2003 S3 - S10 - Figure 2 (2) Int. J. Clin Pract , July 2006, 60, 7, 762 - 769 - Table 6 • Men in th
Slide 7: 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 7 >$2B market in 2012 and growing Increased low testosterone (T) awareness driven by Abbott, Glaxo and Lilly promotion Topicals dominate the market (~90%), market leader Androge
Slide 8: LPCN 1021 Addresses Unmet 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 8 LPCN 1021 Addresses Unmet Need 8 Topical LPCN 1021 ▪ Inadvertent transference • Especially to children and partners • Black box warning on all gels x No transference issue or
Slide 9: Survey of endocrinologists and urologists on oral testosterone compliance
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 Survey of 28 leading endocrinologist and urologist about oral testosterone compliance 1 • In your opinion, will oral testosterone improve patient compliance compared to existi
Slide 10: 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 10 Testosterone Undecanoate (TU, a prodrug of testosterone) oral composition designed for convenient BID dosing Primarily directed at lymphatic delivery Maintains effective test
Slide 11: 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 11 Successful Phase 2 Dose Finding Without Titration % of subjects meeting criteria PK parameters LPCN 1021 225 mg BID Da y 15 (n=24) FDA criteria for approval of TRT Primary En
Slide 12: 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 12 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 products No
Slide 13: LPCN 1021: 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 13 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 14: LPCN 1021 Development Update
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 Phase 3 study underway • First patient dosed early February • 200 patients in active TRT arm • Multicenter (~55 sites) in US FDA concurrence on single pivotal phase III trial
Slide 15: 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 15 Open label, randomized, active - controlled study of LPCN 1021 in men with low testosterone Primary endpoint: serum testosterone concentration at Week 13 LPCN 1021: Phase 3 D
Slide 16: 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 16 Competitive Environment for Oral Testosterone * See Appendix (Adult male BMI Distribution) CLR 610: Clarus Therapeutics Current Status • NDA filed LPCN 1021 Advantages • Simp
Slide 17: 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 17 Novel prodrug of testosterone for oral delivery through proprietary Lip’ral technology Designed to provide balance between adequate bioavailability and sustained daily testos
Slide 18: 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 18 Preterm birth (PTB) is defined as delivery less than 37 weeks of gestation 11.7% of all US pregnancies 1 result in PTB ≥ $26 billion economic impact 2 PTB remains the leading
Slide 19: 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 19 Potential to be the first oral hydroxyprogesterone caproate (HPC) • API is an approved injectable drug for recurrent preterm birth • Elimination of injection site reaction an
Slide 20: 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 20 Top - line Phase 3 efficacy results for – 2H 2014 Complete Phase 3 with safety data – 2H 2015 File NDA – 2H 2015 Significant Value Driving Milestones for LPCN 1021
Slide 21: 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 21 Mahesh Patel, Ph.D.: President, CEO & Co - Founder • Director, Specialty products, Pharmacia and Upjohn Morgan Brown, CPA: Executive Vice President & CFO • CFO, Innovus Pharm
Slide 22: Lipocine 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 22 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) strategy
Slide 23: 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 24: 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 24 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 wi
Slide 25: 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 25 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 26: 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 26 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 27: 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 27 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 28: 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 28 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 29: 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 29 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,
Slide 30: LPCN 1107: 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 30 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 from H