Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (June 2015)
28 slides from Lipocine's investor presentation, Jun 1, 2015
Slide 1: Corporate Presentation June 2015
Corporate Presentation June 2015 Exhibit 99.1
Slide 2: Forward Looking Statements
Forward Looking Statements 2 This presentation contains 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 forward - looking statements rel
Slide 3: Lipocine Corporate Highlights
Lipocine Corporate Highlights 3 ▪ Focused on innovative products for men’s and women’s health ▪ Lead asset NDA filing 2H 2015 • Phase 3 study complete: positive efficacy results with 52 - week safety results expected in June 2015 • No drug or cardiac related serious adverse events • Pre - NDA meetin
Slide 4: Product Pipeline
Product Pipeline 4 PRODUCT (Indication) RESEARCH / PRECLINICAL PHASE 1 PHASE 2 PHASE 3 UNDER REVIEW MEN'S HEALTH LPCN 1021 (BID Oral Testosterone Replacement Therapy ) LPCN 1111 (Next Generation QD Oral T) WOMEN'S HEALTH LPCN 1107 (Prevention of preterm birth)
Slide 5: Lip'ral Enables Optimal Dispersion in the Gastrointestinal Tract
Lip’ral Enables Optimal Dispersion in the Gastrointestinal Tract Improved absorption Effective transfer across aqueous barrier layer Optimal dispersed phase in GI tract Insoluble drug lipidic composition 5
Slide 6: Testosterone Replacement Therapy Market
Testosterone Replacement Therapy Market ▪ US market > $2.3B in 2013 1 ▪ US market ~ 6.5M TRx in 2014 1 • 13% decrease in TRx from 2013 • Run rate of ~ 6.0M TRx in 2015 1 ▪ International markets for TRT growing ▪ Topicals dominate the market (~86% 1 of $ sales in 2014) • Inadvertent transference issu
Slide 7: Oral Expected to Improve Compliance and Patient Retention
Oral Expected to Improve Compliance and Patient Retention ▪ Survey of 28 leading endocrinologists and urologists about oral testosterone compliance 1 • In your opinion, will oral testosterone improve patient compliance compared to existing options? x Oral T is expected to increase per patient revenu
Slide 8: LPCN 1021: Oral Treatment Option for TRT
LPCN 1021: Oral Treatment Option for TRT ▪ 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
Slide 9: LPCN 1021: A "Safer" TRT Option
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 Greater risk of cardio
Slide 10: LPCN 1021: Life "Uninterrupted" with Oral T
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 10
Slide 11: LPCN 1021 Target Clinical Success Criteria
LPCN 1021 Target Clinical Success Criteria 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 (CI) ▪ Acceptable safety profile • Responder analysis relating to peak testoster
Slide 12: SOAR Trial - Primary Endpoint: Responder Analysis and Cavg
SOAR Trial - Primary Endpoint: Responder Analysis and C avg 12 Measure FDA Targets Efficacy Population* 1 Full Analysis Set #1 Number of subjects 152 192 % subjects with C avg w ithin normal range ≥75% 88.2% 87.5% 95 % CI lower bound ≥ 65% 81.9% 82.0% x LPCN 1021 met both the primary endpoint target
Slide 13: SOAR Trial - Titration Visits
SOAR Trial - Titration Visits Dataset: Efficacy population, N=152 13 Parameter % of subjects % subjects requiring no more than one dose change (either after week 3 or week 7) 85% % subjects requiring two dose changes (both after week 3 and 7) 15% x Vast majority of subjects reached final dose with n
Slide 14: SOAR Trial - Secondary Endpoints
SOAR Trial - Secondary Endpoints ▪ Proportion of subjects achieving maximum serum total T concentrations (Cmax) in predefined Cmax range 14 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 > 2500 ng/ dL None
Slide 15: SOAR Trial - LPCN 1021 Excessive T Repletion Outliers
SOAR Trial - LPCN 1021 Excessive T Repletion Outliers ( C max >2500 ng/ dL ) Characteristics ▪ Excessive T repletion outliers were observed in three subjects ▪ These observed excessive T repletion outliers were transient, sporadic, isolated, and not clinically meaningful • Lack of dose or dosing tim
Slide 16: Recent FDA TRT Communication (March 3, 2015)
Recent FDA TRT Communication (March 3, 2015) 16 ▪ Changes to existing label • Require hypogonadism to be confirmed by both signs and symptoms as well as laboratory values • Add cautionary language to label for possible cardio vascular and stroke related risk with TRT • Add cautionary language on lac
Slide 17: FDA Pre-NDA Meeting Results (March 19, 2015)
FDA Pre - NDA Meeting Results (March 19, 2015) ▪ FDA confirmed that the design of the Phase 3 clinical study is currently acceptable for filing a NDA ▪ Obtained concurrence regarding adequacy for submission of the proposed NDA package ▪ FDA did not identify any additional clinical studies that would
Slide 18: Competitive Environment for Oral Testosterone
Competitive Environment for Oral Testosterone Rextoro™: Clarus Therapeutics Current Status • Advisory Committee voted 18 - 3 that the overall benefit/risk profile of Rextoro® did not support approval • PDUFA date was November 3, 2014 - no announcement of approval LPCN 1021 Advantages • Unequivocally
Slide 19: LPCN 1111: Next Generation Oral Testosterone
LPCN 1111: Next Generation Oral Testosterone ▪ 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 x Single daily oral dose provides T levels in
Slide 20: LPCN 1111 Phase 2a Study - Responder Analysis
LPCN 1111 Phase 2a Study - Responder Analysis At Day 28 x Once daily dosing feasibility established 20 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
Slide 21: Preterm Birth (PTB) Represents a Significant Unmet Medical Need
Preterm Birth (PTB) Represents a Significant Unmet Medical Need ▪ 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 billion economic impact: 4 $1 billion market oppo
Slide 22: LPCN 1107: Oral Candidate for Prevention of Preterm Birth
LPCN 1107: Oral Candidate for Prevention of Preterm Birth ▪ 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
Slide 23: LPCN 1107: Phase Study Results
LPCN 1107: Phase 1 Study Results 23 * one subject data analysis pending # AUCss calculated for post steady state 1 week duration Study population (N) AUC SS ( ng.h /ml) # Relative bioavailability [oral / IM] LPCN 1107/ 400 mg BID Oral Intramuscular Injection / 250 mg weekly Pregnant women (7*) 1074
Slide 24: Competitive Environment for HPC for Prevention of Preterm Birth
Competitive Environment for HPC for Prevention or Preterm Birth Makena®: AMAG Pharmaceuticals, Inc. Current Status • Recently acquired from Lumara Health in November 2014 for $675M in upfront payments and potential additional contingent consideration of up to $350M • Net sales of Makena in 2014 were
Slide 25: Near Term Value Drivers
Near Term Value Drivers 25 1Q 2015 2Q 2015 3 Q 2015 4 Q 2015 4 Q 2016 LPCN 1021: 1 Year Safety Data LPCN 1107: Initiate PK Dose Finding Study LPCN 1021: File NDA LPCN 1111: Initiate Phase 2b Study 2Q 2016 3 Q 2016 1Q 2016 LPCN 1021: FDA Approval LPCN 1021: Food Effect Data
Slide 26: Experienced Management and Directors
Experienced Management and Directors 26 Management Directors Mahesh Patel, Ph.D Chairman, President and Chief Executive Officer ▪ 20+ years of technology and product development experience in the area of drug discovery support, drug delivery and product line extensions ▪ Prior Affiliations: Pharmaci
Slide 27: Lipocine is a Compelling Value Proposition
Lipocine is a Compelling Value Proposition 27 Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Closing Stock Price (5/29/15) $7.05/share Market Capitalization (5/29/15) $123.4 million Fully Diluted Shares Outstanding (5/29/15) 19,716,586 Cash Balance (3/31/14)* $24.8 million Debt None * On A
Slide 28: Lipocine Corporate Highlights
Lipocine Corporate Highlights 28 ▪ Focused on innovative products for men’s and women’s health ▪ Lead asset NDA filing 2H 2015 • Phase 3 study complete: positive efficacy results with 52 - week safety results expected in June 2015 • No drug or cardiac related serious adverse events • Pre - NDA meeti