Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (January 2015)
37 slides from Lipocine's investor presentation, Jan 12, 2015
Slide 1: Corporate Presentation January 2015
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 2015 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 Corporate 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 Corporate Highlights Focused on innovative products for men’s and women’s health • “Transformative” oral testosterone franchise • First oral alternative for the preve
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 Product Pipeline LPCN 1021 - Oral Testosterone Replacement Therapy (TRT) Men’s Health LPCN 1111 - Next Generation Oral TRT Women’s Health LPCN 1107 - Pregnancy Support: Preven
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: Near Term Value Drivers
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 Near Term Value Drivers 4Q 2014 1 Q 2015 2 Q 2015 3 Q 2015 4Q 2015 LPCN 1021: Complete Phase 3 with Safety Data LPCN 1021: File NDA LPCN 1111: Initiate Phase 2B Study
Slide 7: 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 7 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 t
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 US market > $2.3B in 2013 1 US market ~ 5.5M TRx through October 2014 1 International markets for TRT growing Current TRT “class label” under review by FDA Topicals dominate t
Slide 9: 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 9 Survey of 28 leading endocrinologists and urologists about oral testosterone compliance 1 • In your opinion, will oral testosterone improve patient compliance compared to exis
Slide 10: If Approved, Oral T Will Likely Change the Landscape
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 If Approved, Oral T…. ” will likely dramatically change the landscape with regard to testosterone therapies, because the oral route of administration will be considerably eas
Slide 11: LPCN 1021: Oral Treatment Option for TRT
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 Novel product primarily directed at lymphatic delivery of Testosterone Undecanoate (TU) Enhanced profile over other forms of testosterone (T) • Natural T has short half life
Slide 12: LPCN 1021: A Safer TRT Option
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 LPCN 1021: A “Safer” TRT Option Transfer potential to children, partner and pets No freedom to use around pregnant loved ones Skin irritation potential Lung impairment potent
Slide 13: LPCN 1021: Life Uninterrupted with Oral T
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 LPCN 1021: Life “Uninterrupted” with Oral T x Discrete x No waiting • Prior to dressing • In doctor’s office x Suitable for “on the go” use x No shower/swim restrictions x No
Slide 14: 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 14 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 Interval
Slide 15: 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 15 Open label, randomized, active - controlled study of LPCN 1021 in men with low T Study of Oral Androgen Replacement (SOAR) Trial - Phase 3 Study Design Screening N = 315 0 We
Slide 16: 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 16 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 d
Slide 17: SOAR Trial - Primary Endpoint: Responder Analysis and Cavg
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 - 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 18: Primary Endpoint: Cavg and Distribution in 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 18 Primary Endpoint: C avg and Distribution in Subjects Range Efficacy Population C avg < 300 ng / dL 11.2 % C avg betwee n 300 and 1140 ng/ dL 88.2 % C avg > 1140 ng / dL 0.7 %
Slide 19: 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 19 Final 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
Slide 20: 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 20 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 21: 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 21 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 22: 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 22 Excessive T repletion outliers were observed in three subjects These observed excessive T repletion outliers were transient, sporadic, isolated, and not clinically meaningful
Slide 23: SOAR Trial - LPCN 1021 Top Line Phase 3 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 23 Unequivocally met primary efficacy end point Patient friendly dosing regimen • No more than one titration required in 85% of the subjects • Starting dose was the right dose f
Slide 24: TRT Advisory Committee Meeting
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 TRT Advisory Committee Meeting US FDA Advisory committee meeting Topics for Discussion • Appropriate population for testosterone replacement therapy • Potential for adverse c
Slide 25: FDA Confirmation to Lipocine
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 FDA confirmed that the design of the Phase 3 clinical study is currently acceptable for filing a NDA FDA noted that a sufficient number of subjects are required with at least
Slide 26: 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 26 Competitive Environment for Oral Testosterone Rextoro™: Clarus Therapeutics Current Status • Advisory Committee voted 18 - 3 that the overall benefit/risk profile of Rextoro®
Slide 27: 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 27 Novel prodrug of testosterone for oral delivery through proprietary Lip’ral technology Maintains effective T blood levels when dosed once daily Status • Positive Phase 2a stu
Slide 28: 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 28 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) Successful ou
Slide 29: 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 29 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 30: 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 30 Preterm Birth (PTB) Represents a Significant Unmet Medical Need One Preterm Infant per Minute in the US 1 □ 11.7% of all US pregnancies 2 result in PTB - a leading cause of m
Slide 31: LPCN 1107: Oral Candidate for Prevention of 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 31 Potential to be the first oral standard - of care therapy • Same API as in the only approved injectable product • Elimination of 18 - 22 injections • Potential for orphan dru
Slide 32: LPCN 1107: Phase 1b Pregnant Women Study - Design and Outcomes
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 Open - label, three period, three treatment serial dosing study (N=8) • Period 1 : Two doses, 400 mg LPCN 1107 administered 12 hours apart • Period 2: Two doses, 800 mg LPCN
Slide 33: LPCN 1107: Phase 1b Study in Pregnant Women - 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 33 LPCN 1107: Phase 1b Study in Pregnant Women - Results * one subject data analysis pending Single dose pharmacokinetic parameters Dose (BID) (N=7*) C max (ng/ml) [range] AUC 0
Slide 34: LPCN 1107: Phase 1b Study - Simulated Steady State PK
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 34 LPCN 1107: Phase 1b Study in Pregnant Women - Results * one subject data analysis pending # AUCss calculated for post steady state 1 week duration Simulated steady state phar
Slide 35: LPCN 1107: Phase 1b Study - Bioavailability
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 35 LPCN 1107: Phase 1b Study in Pregnant Women - Results * one subject data analysis pending # AUCss calculated for post steady state 1 week duration Bioavailability in pregnant
Slide 36: 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 36 Lipocine is a Compelling Value Proposition Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Closing Stock Price (12/31/14) $5.26/share Market Capitalization (12/31/14
Slide 37: Lipocine Corporate 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 37 Lipocine Corporate Highlights Focused on innovative products for men’s and women’s health • “Transformative” oral testosterone franchise • First oral alternative for the prev