Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (February 2016)
28 slides from Lipocine's investor presentation, Feb 16, 2016
Slide 1: Lipocine: Enhancing Health
LIPOCIN= ENHANCING HEALTH February 2016
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 stat ements re
Slide 3: Focused on Innovative Products for Men's and Women's Health
LPCN: Focused on Innovative Products for Men’s and Women’s Health 3 “Transformative“ Oral Testosterone Franchise First Oral Alternative for the Prevention of Pre - Term Birth PRODUCT (Indication) RESEARCH / PRECLINICAL PHASE 1 PHASE 2 PHASE 3 NDA UNDER REVIEW MEN'S HEALTH LPCN 1021 (Oral Testosteron
Slide 4: Lipocine Investment Highlights
Lipocine Investment Highlights ▪ Lipocine is well positioned to be a leader in Oral Testosterone – Targeting ~$2.0 Billion TRT US market – Differentiated products – LPCN 1021 has potential to be the first oral treatment option ▪ NDA PDUFA goal date of June 28, 2016 – LPCN 1111 QD option in Phase 2 a
Slide 5: 1021 - First Oral TRT Option (PDUFA Goal Date of June 28, 2016)
LPCN 1021 - First Oral TRT Option (PDUFA Goal Date of June 28, 2016) ▪ NDA Accepted in October 2015 – Targeting Class TRT label – No “black box” warning expected – No Advisory Committee m eeting planned ▪ Potential to be the first approved oral TRT option – Demonstrated efficacy in pivotal Phase 3 c
Slide 6: Adherence to Current TRT Treatment Is Poor
Adherence to Current TRT Treatment Is Poor ▪ Median persistency on a TRT brand is 3 - 4 months (~100 days) MABI’s TRT Patient Metrics (Powered by Source Healthcare Analytics Patient Data). All trademarks acknowledged. 36.7% 23.4% 19.2% 17.1% 16.9% 10.9% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% M+
Slide 7: Testosterone Replacement Therapy Market
Testosterone Replacement Therapy Market 7 IMS Health Dec 2015. $0.0 $0.5 $1.0 $1.5 $2.0 $2.5 2013 2014 2015 Billions ($) Gross Sales Testosterone - Injectable Depo-Testosterone Testopel Testosterone - Transdermal Fortesta Androderm Testim Axiron AndroGel 1.62% AndroGel 1% 0 1 2 3 4 5 6 7 8 2013 2014
Slide 8: TRT Monthly TRx Trend
TRT Monthly TRx Trend 8 x To date, minimal TRx impact of FDA TRT label change x 2015 – monthly TRx stable around 500,000/month 1 IMS Data - 100,000 200,000 300,000 400,000 500,000 600,000 Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15 TRT TRx's FDA Label Guidance
Slide 9: Issues with Current TRT Therapies
9 Issues with Current TRT Therapies Transfer potential to children and partner No freedom to use around pregnant loved ones Skin irritation potential Messy to apply and wait to dress Pulmonary embolism potential Pain from injection Needle phobia, needle fatigue Scarring/injection sit
Slide 10: 1021 - First Oral TRT Option: Challenges of Oral T
LPCN 1021 - First Oral TRT Option Challenges of Oral T Product ▪ Native testosterone has poor oral bioavailability with a very short half life (~30 min) – Impractical daily doses would be required to obtain effective levels – Inconsistent and unpredictable performance – Methyl testosterone – Liver t
Slide 11: Over 80% of Patient Respondents Are Likely To Ask About Oral T
Over 80% of Patient Respondents Are Likely To Ask About Oral T 14.1 % 19.2 % 38.4 % 32.3 % 47.5 % 48.5 % 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Rx < 6Mo n=99 Current Rx n=412 Percent of Respondents Likelihood to Ask Prescriber About Oral LPCN 1021 Rate 1 - 3 Rate 4 - 7 Rate 8 - 10 Q30. How like
Slide 12: LPCN 1021: Primary Efficacy Results in Phase 3
12 LPCN 1021 (First Oral TRT Option): Primary Efficacy Results in Phase 3 Measure FDA Targets Efficacy Population* 1,2 Full Analysis Set #1 Number of subjects 151 193 % subjects with C avg w ithin normal range ≥75% 87.4% 87.0% 95 % CI lower bound ≥ 65% 81.7% 82.0% x LPCN 1021 met both the primary en
Slide 13: 1021: Secondary Endpoints in Phase 3
LPCN 1021 (First Oral TRT Option): Secondary Endpoints in Phase 3 ▪ Proportion of subjects achieving maximum serum total T concentrations (Cmax) in predefined Cmax range 13 Measure FDA Threshold Efficacy Population Number of subjects 151 C max < 1500 ng/ dL ≥ 85 % 82.8% 1800 ≤ C max ≤ 2500 ng/ dL ≤
Slide 14: LPCN 1021: 52 Week Safety Results
14 LPCN 1021 (First Oral TRT Option): 52 Week Safety Results ▪ LPCN 1021 was well tolerated during 52 weeks of dosing ▪ No reported cardiac, hepatic or drug related serious adverse events (SAEs) ▪ Overall adverse event (AE) profile for LPCN 1021 was comparable to the active control, Androgel ® 1.62%
Slide 15: 1021: Attributes of Special Interest
LPCN 1021 (First Oral TRT Option): Attributes of Special Interest Attributes LPCN 1021 Efficacy Robust to Sensitivity Analysis Consistent Inter - day / Intra - day Performance Yes Meal Fat E ffect T levels not sensitive to fat content Safety No cardiac, hepatic, or drug related SAEs DHT Levels Compa
Slide 16: Potential for Meaningful Oral T Sales in U.S.
Potential for Meaningful Oral T Sales in U.S. 16 Market Share Sales Potential ( in M) Assumptions: • $400/Rx current TRT Branded pricing; • 6 Million Annual US TRT TRx (excludes ex - US, expansion due to improved Rx retention rates due to oral introduction and physician “buy and bill” sales) For Ill
Slide 17: 1111 (Next Generation Oral TRT Option): Once Daily
LPCN 1111 (Next Generation Oral TRT Option): “Once Daily” ▪ Novel prodrug of testosterone for oral delivery through proprietary drug delivery technology ▪ Once daily is expected to sustain and improve market share or oral T franchise ▪ Once daily feasibility established – Positive Phase 2a study res
Slide 18: 1111: Study Design
LPCN 1111 (Next Generation Oral TRT Option): Study Design 18 ▪ Open label, two - period, multiple dose PK study ▪ 36 hypogonal males ▪ Three dose levels of LPCN 1111 in Period 1 (500mg, 750mg, and 1000mg) ▪ Two dose levels of LPCN 1111 in Period 2 (250mg QD or 1250mg QD, 500mg BID) ▪ Subjects (36) r
Slide 19: 1111 Phase 2a Study - Responder Analysis
LPCN 1111 Phase 2a Study - Responder Analysis At Day 28 x Once daily dosing feasibility established 19 Measure 550mg QD 770mg QD Typical FDA targets for approval of TRT C avg w ithin normal range 67% 88% ≥ 75% C max < 1500 ng / dL 100% 100% ≥ 85% 1800 ≤ C max ≤ 2500 ng / dL 0% 0% ≤ 5% C max > 2500 n
Slide 20: Preterm Birth Represents a Significant Unmet Medical Need
Preterm Birth (PTB) Represents a Significant Unmet Medical Need ▪ 12% of all US pregnancies 2 result in PTB (< 37 weeks) - a leading cause of neonatal 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
Slide 21: Preterm Birth Ranking – Worldwide
Preterm Birth Ranking – Worldwide 1 21 1 : Blencowe H, Cousens S, Oestergaard M, Chou D, Moller AB, Narwal R, Adler A, Garcia CV, Rohde S, Say L, Lawn JE. National, regional and worldwide estimates of preterm birth. The Lancet, June 2012. 9;379(9832):2162 - 72. Estimates from 2010.
Slide 22: PreTerm Birth Related Costs in US
PreTerm Birth Related Costs in US ▪ PTB occurs in 11 % of all births (14.9 million in 2010) worldwide 1 ▪ PTB occurs in 11.7% 2 (~460,000/ 4 millions) US pregnancies in 2011 ▪ PTB related time and costs in intensive care is a major women health issue 3 22 Lost Household and Market Productivity $5.7
Slide 23: 1107 (First Oral PTB Candidate): Addresses Unmet Need
LPCN 1107 (First Oral PTB Candidate): “Addresses Unmet Need” 23 ▪ Potential to be the first oral standard - of care therapy – Elimination of 18 - 22 injections ▪ Orphan drug designation – A major contribution to patient care ▪ Oral feasibility established – Successful Phase 1 studies in healthy non
Slide 24: 1107: Single and Multi-dose Study Design
LPCN 1107 (First Oral PTB Candidate): Single and Multi - dose Study Design 24 ▪ Open label, four - period, four - treatment, single and multiple dose PK study ▪ Three dose levels of LPCN 1107 (400mg BID, 600mg BID, and 800mg BID) ▪ Injectable HPC (Makena®) dose ▪ 12 healthy pregnant women (average a
Slide 25: 1107: Single and Multi-dose Study Results
LPCN 1107 (First Oral PTB Candidate): Single and Multi - dose Study Results 25 ▪ Relevant hydroxyprogesterone caproate levels achieved following oral administration – Average steady state HPC levels (Cavg0 - 24) were comparable or higher for all three LPCN 1107 doses than for injectable HPC – Previo
Slide 26: Several Near Term Value Drivers
Several Near Term Value Drivers 26 Event Expected Timing LPCN 1107: Request End of Phase 2 Meeting 2Q16 LPCN 1111: Top - line Results from Phase 2b Study 2Q16 LPCN 1021: FDA PDUFA Date June 28, 2016 LPCN 1111: End of Phase 2 Meeting 2H16 LPCN 1021: File NDS in Canada 2H16
Slide 27: Lipocine is a Compelling Value Proposition
27 Lipocine is a Compelling Value Proposition Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Closing Stock Price (1/31/16) $9.06/share Market Capitalization (1/31/16) $164.9 million Fully Diluted Shares Outstanding (9/30/15) 19,975,030 Cash Balance (9/30/15) $47.8 million Debt None
Slide 28: Lipocine Investment Highlights
Lipocine Investment Highlights ▪ Lipocine is well positioned to be a leader in Oral Testosterone – Targeting ~$2.0 Billion TRT US market – Differentiated products – LPCN 1021 has potential to be the first oral treatment option ▪ NDA PDUFA goal date of June 28, 2016 – LPCN 1111 QD option in Phase 2 a