Lipocine Inc. · NASDAQ:LPCN
Lipocine — Piper Jaffray 26th Annual Healthcare Conference (November 2014)
18 slides from Lipocine's conference presentation, Nov 26, 2014
Slide 1: Piper Jaffray 26th Annual Healthcare Conference
Piper Jaffray 26 th Annual Healthcare Conference December 2, 2014 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 i nnovative products for men’s and women’s health ▪ “Transformative“ oral testosterone franchise ▪ Oral alternative for the prevention of pre - term birth □ Technology platform capable of “multiple hits” □ Lead asset in Phase 3 ▪ Positive top - line effic
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: Complete Phase 3 with Safety Data LPCN 1021: File NDA LPCN 1111: Initiate Phase 2B Study LPCN 1107: Top Line Results Phase 1B Study
Slide 6: Testosterone Replacement Therapy Market
6 □ US market > $2.3B in 2013 1 □ International markets for TRT growing □ Current TRT “class label” under review by FDA □ Topicals dominate the market (~89 % of $ sales) ▪ Inadvertent transference issue, black box warning ▪ Poor compliance: 86 % discontinue at 12 months 1 □ Existing testosterone tre
Slide 7: Testosterone Deficiency is Prevalent in U.S.
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 their 60s 1 in 5 • Men in their 70s 1 in 4 Only 12% of Men with Low T Receive TRT 2
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 testosterone (T) ▪ Methyl T is known to have liver safety issues ▪ Natural T has short half life □ Maintains effective T blood levels when dosed BID □ Target label — con
Slide 9: SOAR Phase 3 Study Design
9 □ Open label, randomized, active - controlled study of LPCN 1021 in men with low T Study of Oral Androgen Replacement (SOAR) - 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 titrat
Slide 10: SOAR Trial - Primary Endpoint: Responder Analysis
10 SOAR Trial - Primary Endpoint: Responder Analysis and C avg Measure FDA Targets Efficacy Population Safety Set Number of subjects 152 210 % subjects with C avg w ithin normal range ≥ 75% 88.2% 80.0% 95 % CI lower bound ≥ 65% 81.9% 73.8% x LPCN 1021 met both the primary endpoint targets x Robust t
Slide 11: SOAR Trial – LPCN 1021 Top Line Phase 3 Results Summary
11 □ 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 12: LPCN 1021: A "Safer" TRT Option
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 potential Scarring/injection site reactions Risk of infection Not flexible for dose reversals x No risk of transfer
Slide 13: LPCN 1021: Life "Uninterrupted" with Oral T
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 mess/clean up x Non invasive Improved Compliance Convenience Enhanced Efficacy Higher Retention Rates
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: Preterm Birth Represents a Significant Unmet Medical Need
15 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 16: LPCN 1107: Oral Candidate for Prevention of Preterm Birth
16 □ 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 ▪ Phase 1b pharmacokinetic study in pregnant women ongoing – Top l
Slide 17: Lipocine is a Compelling Value Proposition
17 Lipocine is a Compelling Value Proposition Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Last Reported Stock Price (11/24/14) $5.15/share Market Capitalization (11/24/14) $65.8 million Fully Diluted Shares Outstanding (11/24/14) 14,346,876 Warrants Outstanding 0.14% Cash Balance (9/30/
Slide 18: Lipocine Corporate Highlights
18 Lipocine Corporate Highlights □ Focused on innovative products for men’s and women’s health ▪ “Transformative“ oral testosterone franchise ▪ Oral alternative for the prevention of pre - term birth □ Technology platform capable of “multiple hits” □ Lead asset in Phase 3 ▪ Positive top - line effic
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