Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (January 2016)
24 slides from Lipocine's investor presentation, Jan 11, 2016
Slide 1: Lipocine: Enhancing Health
= Exhibit 99.1 LIPOCIN= ENHANCING HEALTH January 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: LPCN 1021 - First Oral TRT Option (PDUFA Goal Date)
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: Men Aged 35-64 Are Primary Users of TRT
Men Aged 35 - 74 Are Primary Users of TRT 0 200,000 400,000 600,000 800,000 1,000,000 1,200,000 1,400,000 1,600,000 1,800,000 2,000,000 ≤25 26-34 35-44 45-54 55-64 65-74 ≥75 Number of TRT Prescriptions TRT Usage by Age SHA Integrated Database 2013, nonprojected claims counts for FDA Advisory Meeting
Slide 7: 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 8: AndroGel and Injectables Capture 70% of Prescriptions
AndroGel and Injectables Capture 70% of Prescriptions 8 IMS Health Sept 2015. $0.0 $0.5 $1.0 $1.5 $2.0 $2.5 2013 2014 2015 Estimate Billions ($) Gross Sales Testosterone - Injectable Depo-Testosterone Testopel Testosterone - Transdermal Fortesta Androderm Testim Axiron AndroGel 1.62% AndroGel 1% 0 1
Slide 9: TRT Monthly TRx Trend
TRT Monthly TRx Trend 9 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 TRT TRx's FDA Label Guidance
Slide 10: Issues with Current TRT Therapies
10 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 si
Slide 11: LPCN 1021 - First Oral TRT Option
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 12: Over 80% of Patient Respondents 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 13: LPCN 1021: Primary Efficacy Results in Phase 3
13 LPCN 1021 (First Oral TRT Option): Primary Efficacy Results in Phase 3 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% 81.7% 82.0% x LPCN 1021 met both the primary endp
Slide 14: LPCN 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 14 Measure FDA Threshold Efficacy Population Number of subjects 151 C max < 1500 ng/ dL ≥ 85 % 82.8% 1800 ≤ C max ≤ 2500 ng/ dL ≤
Slide 15: LPCN 1021: 52 Week Safety Results
15 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 16: 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, or drug related SAEs DHT Levels Compa
Slide 17: Potential for Meaningful Oral T Sales in U.S. Market
Potential for Meaningful Oral T Sales in U.S. 17 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 18: 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 sustain and improve market share or oral T franchise ▪ Once daily feasibility established – Positive Phase 2a study res
Slide 19: 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 20: LPCN 1107 (First Oral PTB Candidate): Addresses Unmet Need
LPCN 1107 (First Oral PTB Candidate): “Addresses Unmet Need” 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
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 1107: Top - line Results from Multi - Dose PK Study 1Q16 LPCN 1021: File NDS in Canada 1H16 LPCN 1111: Top - line Results from Phase 2b Study 2Q16 LPCN 1107: End of Phase 2 Meeting 2Q16 LPCN 1021: FDA PDUFA Date June 28, 2016 LPCN 1111: E
Slide 23: Lipocine is a Compelling Value Proposition
23 Lipocine is a Compelling Value Proposition Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Closing Stock Price (12/31/15) $12.93/share Market Capitalization (12/31/15) $236.0 million Fully Diluted Shares Outstanding (9/30/15) 19,975,030 Cash Balance (9/30/15) $47.8 million Debt None
Slide 24: 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