Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (October 2014)
32 slides from Lipocine's investor presentation, Oct 14, 2014
Slide 1: Corporate Presentation October 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 October 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 Lipocine Investment Highlights ; Focused on developing innovative orally - available treatment alternatives in the areas of men’s and women’s health ; Technology platform capa
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) Archive of Internal Medicine 2008 • Men in their 50s 1 in 10 • Men in
Slide 7: Symptoms of Testosterone Deficiency
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 Symptoms of Testosterone Deficiency
Slide 8: 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 8 ; >$2.3B market in 2013 1 ; Increased low testosterone (T) awareness driven by Abbott and Lilly promotion ; Topicals dominate the market (~89%), market leader Androgel ® ; His
Slide 9: Lipocine's 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 9 Lipocine’s LPCN 1021 Addresses Unmet Need 9 Topical LPCN 1021 ▪ Inadvertent transference • Especially to children and partners • Black box warning on all gels x No transferenc
Slide 10: Oral Expected to Improve Compliance and Patient Retention
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 ; Survey of 28 leading endocrinologists and urologists about oral testosterone compliance 1 • In your opinion, will oral testosterone improve patient compliance compared to e
Slide 11: 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 11 ; Testosterone Undecanoate (TU, a prodrug of testosterone) oral composition • TU is same active as in approved products with long term established use in US and Ex - US marke
Slide 12: Current Regulatory Paradigm
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 Current Regulatory Paradigm 1 ; Meet primary end points • Responder analysis relating to average serum concentration 0 to 24 hours ( C avg ) and lower bound Confidence Interv
Slide 13: SOAR Trial - Phase 3 Study 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 13 ; Open label, randomized, active - controlled study of LPCN 1021 in men with low testosterone SOAR Trial - Phase 3 Study Design Screening N = 315 0 Week 4 Week 8 Randomizatio
Slide 14: SOAR Trial - Dataset Definition
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 ; Primary Analysis Set • Efficacy Population (N=152): Subjects randomized into the study with at least one PK profile and no significant protocol deviations x Imputed missing
Slide 15: SOAR Trial - Primary Endpoint
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 SOAR Trial - Primary Endpoint: Responder Analysis and C avg Measure Efficacy Population Safety Set Number of subjects 152 210 % subjects with C avg w ithin normal range 88.2%
Slide 16: SOAR Trial - Final Dose Distribution of Subjects
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 Dose (mg TU, BID) % of subjects 150 36% 225* 51% 300 13% SOAR Trial - Final Dose Distribution of Subjects Dataset: Efficacy population, N=152 *starting dose x Majority of sub
Slide 17: SOAR Trial - Titration Outcome
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 SOAR Trial - Titration Outcome Dataset: Efficacy population, N=152 Parameter % of subjects % subjects requiring no more than one dose change (either after week 3 or week 7) 8
Slide 18: SOAR Trial - Secondary Endpoints
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 SOAR Trial - Secondary Endpoints Measure FDA Threshold Efficacy Population Number of subjects 152 C max < 1500 ng/ dL ≥ 85 % 82.9% 1800 ≤ C max ≤ 2500 ng/ dL ≤ 5 % 4.6% C max
Slide 19: SOAR Trial - Excessive T Repletion Outliers
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 ; Excessive T repletion outliers were observed in three subjects ; These observed excessive T repletion outliers were transient, sporadic, isolated, and not clinically meanin
Slide 20: SOAR Trial - Adverse Events 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 20 ; Safety study is on - going ; 3% of the subjects reported a serious adverse event • There were no drug related Serious AEs ; 46% of the subjects experienced at least one adv
Slide 21: SOAR Trial - Top Line Results 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 21 ; Met primary efficacy endpoint by successfully restoring testosterone levels to the normal range in 88% of the subjects • Primary endpoint robust to sensitivity analysis ; 8
Slide 22: LPCN 1021 Status
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 LPCN 1021 Status Top - line Phase 3 efficacy results File NDA Complete Phase 3 with safety data 3Q 2014 4Q 2014 1Q 2015 2Q 2015 3Q 2015 4Q 2015
Slide 23: 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 23 Competitive Environment for Oral Testosterone Rextoro™: Clarus Therapeutics Current Status • Advisory Committee voted 18 - 3 that the overall benefit/risk profile of Rextoro®
Slide 24: 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 24 ; Novel prodrug of testosterone for oral delivery through proprietary Lip’ral technology ; Designed to provide balance between adequate bioavailability and sustained daily te
Slide 25: LPCN 1111: Phase 2a Study in Hypogonadal Men
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 ; Five arm, sequential ascending dose study (N=12) • 3 single dose QD arms, (330mg, 550mg and 770mg TT) • 2 multiple dose QD arms for 28 days (550mg and 770mg TT) ; Successfu
Slide 26: LPCN 1111 Phase 2a Study - Responder Analysis
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 1111 Phase 2a Study - Responder Analysis At Day 28 Measure 550mg QD 770mg QD Typical FDA targets for approval of TRT % subjects with C avg w ithin normal range 67% 88% ≥
Slide 27: 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 27 ; Preterm birth (PTB) is defined as delivery less than 37 weeks of gestation ; 11.7% of all US pregnancies 1 result in PTB • Annually 180,000 2 pregnancies with prior history
Slide 28: Pre-Term Births Have a $26 Billion Impact on The US Health System
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 Confidential ; Preterm birth (PTB) is defined as delivery less than 37 weeks of gestation ; PTB occurs in 9.6% of all births (12.9 million) world wide* ; PTB occurs in 11.7%†
Slide 29: 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 29 ; Potential to be the first oral for standard - of care therapy • API is an approved injectable drug for recurrent preterm birth • Elimination of injection site reaction and
Slide 30: LPCN 1107: Phase I Study in Healthy Non-Pregnant Females
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 ; Randomized cross - over design(N=10) • Single dose, 400 mg LPCN 1107 • Two doses, 400 mg LPCN 1107 administered 12 hours apart • Single dose of 250 mg IM HPC ; Successful o
Slide 31: Lipocine is a Compelling Value Proposition
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 31 Lipocine is a Compelling Value Proposition Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Last Reported Stock Price (10/1/14) $5.51/share Market Capitalization (10/
Slide 32: 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 32 Lipocine Investment Highlights ; Focused on developing innovative orally - available treatment alternatives in the areas of men’s and women’s health ; Technology platform cap