Lipocine Inc. · NASDAQ:LPCN
Lipocine — Cowen 35th Annual Healthcare Conference 2015
20 slides from Lipocine's conference presentation, Mar 2, 2015
Slide 1: Cowen 35th Annual Healthcare Conference
Cowen 35 th Annual Healthcare Conference March 4, 2015 Exhibit 99.2
Slide 2: Forward-looking statements
2 This presentation contains and our discussions during this conference may include forward - looking statements about Lipocine Inc. (the “Company”). These forward - looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forw
Slide 3: Lipocine Corporate Highlights
3 Lipocine Corporate Highlights ; Focused on innovative products for men’s and women’s health ; Lead asset NDA filing 2H 2015 ; Technology platform capable of “multiple hits” ; Several near term value drivers with pipeline products “Transformative“ Oral Testosterone Franchise First Oral Alternative
Slide 4: Product Pipeline
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: Prevention of Preterm Birth Research/Preclinical Phase 1 Phase 2 Phase 3
Slide 5: Near Term Value Drivers
5 Near Term Value Drivers 4Q 2014 1 Q 2015 2 Q 2015 3 Q 2015 4Q 2015 LPCN 1021: 1 Year Safety Data LPCN 1021: File NDA LPCN 1107: FDA Development Guidance Meeting LPCN 1021: Pre - NDA Meeting with the FDA LPCN 1021: Last Patient Last Visit LPCN 1111: Initiate Phase 2b Study* * Subject to FDA clarity
Slide 6: Testosterone Deficiency is Prevalent in U.S.
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 their 60s 1 in 5 • Men in their 70s 1 in 4 Only 12% of Men with Low T Receive TRT 2
Slide 7: Testosterone Replacement Therapy Market
7 ; US market > $2.3B in 2013 1 ; US market ~ 6.5M TRx in 2014 1 • 13% decrease in TRx from 2013 ; Current TRT “ class” label under review by FDA in US ; International markets for TRT growing ; Topicals dominate the market (~ 86% 1 of $ sales) • Inadvertent transference issue, black box warning • Po
Slide 8: LPCN 1021: Oral Treatment Option for TRT
8 ; Novel product primarily directed at lymphatic delivery of Testosterone Undecanoate (TU) ; Enhanced profile over other forms of oral testosterone (T) • Native T has short half life • Methyl T is known to have liver safety issues ; Maintains effective T blood levels when dosed BID ; Target label —
Slide 9: LPCN 1021: A "Safer" TRT Option
9 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 potential ; Scarring/injection site reactions ; Risk of infection ; Not flexible for dose reversals x No risk of transfere
Slide 10: LPCN 1021: Life "Uninterrupted" with Oral T
10 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 mess/clean up x Non invasive Improved Compliance Convenience Enhanced Efficacy Higher Retention Rates
Slide 11: SOAR Trial Phase 3 Study Design
11 ; 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 Week 4 Week 8 Randomization LPCN 1021 225mg, TU, BID w/ meal (n = 210) Active Control (n = 105) PK /dose titration PK /dose
Slide 12: SOAR Trial - Primary Endpoint: Responder Analysis
12 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% 80.0% 95 % CI lower bound 81.9% 73.8% Parameter Mean (CV) C avg ( ng / dL ) 447 (37%) ; Primary endpoint target ≥ 75% subj
Slide 13: SOAR Trial – LPCN 1021 Top Line Phase 3 Results Summary
13 ; 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 for majority of the subjects ; Variability consistent with or better than approved products ; Consistent intra/inter day
Slide 14: LPCN 1111: Next Generation Oral Testosterone
14 ; 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 study results in hypogonadal men – Single daily oral dose provides T levels in the eugonadal range – No subject exceeded
Slide 15: LPCN 1111 Phase 2a Study - Responder Analysis
15 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% ≥ 75% % of subjects with C max ≤ 1500ng/ dL 100% 100% ≥ 85% % of subjects with C max between 1800ng/ dL and 2500mg/dl 0% 0%
Slide 16: Preterm Birth Represents a Significant Unmet Medical Need
16 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 mortality and morbidity 3 □ ~10x more first year medical costs are for PTB infants than for full term infants 4 □ ≥ $26 bill
Slide 17: LPCN 1107: Oral Candidate for Prevention of Preterm Birth
17 ; 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 drug designation ; Status • Successful Phase 1a POC study in healthy non - pregnant women • Successful Phase 1b POC in pregn
Slide 18: LPCN 1107: Phase 1b Study in Pregnant Women - Results
18 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 (study LPCN 1107 - 14 - 003) and non - pregnant women (study LPCN 1107 - 14 - 001) Study population (N) AUC SS ( ng.h /m
Slide 19: Lipocine is a Compelling Value Proposition
19 Lipocine is a Compelling Value Proposition Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Closing Stock Price (2/27/15) $7.24/share Market Capitalization (2/27/15) $92.7 million Fully Diluted Shares Outstanding (2/27/15) 14,356,586 Warrants Outstanding 0.14% Cash Balance (9/30/14) $31.7
Slide 20: Lipocine Corporate Highlights
20 Lipocine Corporate Highlights ; Focused on innovative products for men’s and women’s health ; Lead asset NDA filing 2H 2015 ; Technology platform capable of “multiple hits” ; Several near term value drivers with pipeline products “Transformative“ Oral Testosterone Franchise First Oral Alternative
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