Lipocine Inc. · NASDAQ:LPCN
Lipocine — Ladenburg Thalmann 2015 Healthcare Conference
24 slides from Lipocine's conference presentation, Sep 29, 2015
Slide 1: Ladenburg Thalmann 2015 Healthcare Conference
Ladenburg Thalmann 2015 Healthcare Conference September 29, 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 stat ements re
Slide 3: Lipocine Investment Highlights
Lipocine Investment Highlights ▪ First oral testosterone replacement option – Targeting ~ $2.0 Billion TRT market – NDA submitted August 2015 – Differentiated from existing products ▪ Orphan designated oral alternative for the prevention of preterm birth – A voids painful injections of the only FDA
Slide 4: Focused on Innovative Products for Men's and Women's Health
LPCN: Focused on Innovative Products for Men’s and Women’s Health 4 “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 5: LPCN 1021 - First Oral TRT Option (NDA Submitted)
LPCN 1021 - First Oral TRT Option (NDA Submitted) ▪ Robust efficacy established in pivotal P hase 3 clinical study – Met FDA primary efficacy endpoint targets ▪ Completed the 52 week safety extension arm – Well tolerated ▪ Overall AE profile comparable to active control, Androgel ® 1.62% (market lea
Slide 6: TRT Treated Patients
TRT Treated Patients 6 Symphony Healthcare Solutions extracted May 2014 for FDA Advisory meeting 1.2M 1.5 2.0 2.2 2.0 0 500000 1000000 1500000 2000000 2500000 2010 2011 2012 2013 2014 Male Testosterone Patients Male T Pts Treatment Rate x Treated patients rates declined in 2014 due primarily to an e
Slide 7: Dollar Sales in the TRT Market Remain Dominated by Gels
Dollar Sales in the TRT Market Remain Dominated by Gels x Total TRx’s are stabilizing in 2015 with injectable products’ TRx volumes continuing to increase IMS Health Sept 2015 8 $0.0 $0.5 $1.0 $1.5 $2.0 $2.5 2013 2014 2015 Sales by administration (in billions, $) 0 1 2 3 4 5 6 7 8 9 2013 2014 2015 T
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 FDA Label Guidance
Slide 9: Adherence after Months on Existing Non-Oral TRT Therapies
Adherence after 12 Months on Existing Non - Oral TRT Therapies 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% M+1 M+2 M+3 M+4 M+5 M+6 M+7 M+8 M+9 M+10 M+11 M+12 Percent of Patients Remaining “On Therapy” TRT Market: “On Therapy” Persistency Based on New - to - Market Cohorts (July 2013) Androderm Andro
Slide 10: LPCN 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) – Multiple daily doses would be required to obtain effective levels ▪ Methyl testosterone – Liver toxicity – Unsafe for chronic use LPCN 1021 adva
Slide 11: LPCN 1021: Efficacy Results in Phase 3
LPCN 1021 (First Oral TRT Option): “Efficacy Results in Phase 3” 11 Measure FDA Targets Efficacy Population* 1 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% 81.9% 82.0% x LPCN 1021 met both the primary endpoint t
Slide 12: LPCN 1021: 52 Week Safety Results
12 LPCN 1021 (First Oral TRT Option): 52 Week Safety Results ▪ LPCN 1021 was well tolerated during 52 weeks of dosing ▪ No reported cardiac, hepatic, gastrointestinal or drug related serious adverse events (SAEs) ▪ Overall adverse event (AE) profile for LPCN 1021 was comparable to the active control
Slide 13: LPCN 1021: T Levels Not Sensitive to Meal Fat Variations
LPCN 1021 (First Oral TRT Option): “ T Levels N ot S ensitive T o M eal F at Variations” 13 0 500 1000 1500 2000 2500 0 4 8 12 16 20 24 Mean (+SD) Serum T Concentration (ng/dL) Time (hr) Low Fat Standard Fat High Fat 1 Low Fat = About 15% total calories derived from fat content in the meal; Standard
Slide 14: LPCN 1021: Efficient Dosing Regimen
14 41 48 11 2 37 61 0 10 20 30 40 50 60 70 No dose change 1 dose change 2 dose changes % of Subjects LPCN 1021 Active Control x 89% of LPCN and 39% of active control subjects (Androgel® 1.62%) required ≤1 dose adjustment x Almost all subjects on active control, the market leader, required a titratio
Slide 15: LPCN 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, gastrointestinal or drug related SAEs
Slide 16: Meaningful Oral T US Sales Potential
Meaningful Oral T US Sales Potential - Across a wide range of price and market share assumptions 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 intro
Slide 17: LPCN 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 improve and sustain market share or oral T franchise ▪ Once daily feasibility established – Positive Phase 2a study res
Slide 18: Preterm Birth 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 (< 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
Slide 19: LPCN 1107 (First Oral PTB Candidate): Addresses Unmet Need
LPCN 1107 (First Oral PTB Candidate): “Addresses Unmet Need” ▪ The only FDA approved product for the prevention of PTB is an injectable hydroxyprogesterone caproate (HPC) ▪ Issues with the injectable HPC: – Weekly injection in doctor’s office or home – Injection site pain (35%), swelling (17%) • LPC
Slide 20: LPCN 1107 (First Oral PTB Candidate): Status
LPCN 1107 (First Oral PTB Candidate): “Status” 20 ▪ 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 - pregnant wom
Slide 21: LPCN 1107: Phase 1 Study Results
LPCN 1107 (First Oral PTB Candidate): Phase 1 Study Results 21 # AUCss calculated for post steady state 1 week duration Study population (N) AUC SS ( ng.h /ml) # Relative bioavailability [400 mg BID oral / IM ] Relative bioavailability [800 mg BID oral / IM] LPCN 1107/ 400 mg BID Oral LPCN 1107/ 800
Slide 22: Several Near Term Value Drivers
Several Near Term Value Drivers 22 Event Expected Timing LPCN 1021: Anticipated NDA 74 day letter November 2015 LPCN 1111: Initiate Phase 2b Study 4Q15 LPCN 1107: Initiate PK Multi - Dose Finding Study 4Q15 LPCN 1107: End of Phase 2 Meeting 2Q16 LPCN 1111: End of Phase 2 Meeting 2Q16 LPCN 1021: Expe
Slide 23: Lipocine is a Compelling Value Proposition
Lipocine is a Compelling Value Proposition 23 Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Closing Stock Price (9/25/15) $14.55 share Market Capitalization (9/25/15) $265 million Fully Diluted Shares Outstanding (9/25/15) 19,716,586 Cash Balance (6/30/15) $53.4 million Debt None
Slide 24: Lipocine Investment Highlights
Lipocine Investment Highlights ▪ First oral testosterone replacement option – Targeting ~ $2.0 Billion TRT market – NDA submitted August 2015 – Differentiated from existing products ▪ Orphan designated oral alternative for the prevention of preterm birth – A voids painful injections of the only FDA
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