Lipocine Inc. · NASDAQ:LPCN
Lipocine — 27th Annual Roth Conference 2015
21 slides from Lipocine's conference presentation, Mar 6, 2015
Slide 1: 27th Annual Roth Conference
27 th Annual Roth Conference March 11, 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 – guidance provided International markets for TRT growing Topicals dominate the market (~ 86% 1 of $ sales) • Inadvertent transference issue, bl
Slide 8: Recent FDA TRT Communication (March 3, 2015)
8 Recent FDA TRT Communication (March 3, 2015) Changes to existing label • Narrow the intended TRT population (i.e., caused by certain medical conditions and confirmed by laboratory tests) • However, the language did not suggest contra - indicating for age related hypogonadism • Add cautionary lan
Slide 9: LPCN 1021: Oral Treatment Option for TRT
9 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 10: LPCN 1021: A "Safer" TRT Option
10 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 transfer
Slide 11: LPCN 1021: Life "Uninterrupted" with Oral T
11 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 12: SOAR Trial - Phase 3 Study Design
12 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 13: SOAR Trial - Primary Endpoint: Responder Analysis and Cavg
13 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 14: SOAR Trial – LPCN 1021 Top Line Phase 3 Results Summary
14 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 15: LPCN 1111: Next Generation Oral Testosterone
15 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 16: LPCN 1111 Phase 2a Study - Responder Analysis
16 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 17: Preterm Birth Represents a Significant Unmet Medical Need
17 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 18: LPCN 1107: Oral Candidate for Prevention of Preterm Birth
18 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 19: LPCN 1107: Phase 1b Study in Pregnant Women - Results
19 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 20: Lipocine is a Compelling Value Proposition
20 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 21: Lipocine Corporate Highlights
21 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