Slide 1: Corporate Presentation September 2015
Click to edit Master title style Corporate Presentation September 2015 Exhibit 99.1
Slide 2: Forward Looking Statements
Click to edit Master title style 2 Forward Looking Statements 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
Slide 3: Investment Highlights
Click to edit Master title style Investment Highlights ▪ Specialty pharma company focused on innovative products for men’s and women’s health ▪ LPCN 1021: Oral testosterone replacement therapy product candidate • Submitted NDA on August 27, 2015 • T argeting ~ $2.0 Billion TRT market ▪ LPCN 1111: Ne
Slide 4: Lip'ral Enables Optimal Dispersion in the Gastrointestinal Tract
Click to edit Master title style 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 4
Slide 5: Focused on Innovative Products for Men's and Women's Health
Click to edit Master title style 5 LPCN: Focused on Innovative Products for Men’s and Women’s Health “Transformative“ Oral Testosterone Franchise First Oral Alternative for the Prevention of Pre - Term Birth PRODUCT (Indication) RESEARCH / PRECLINICAL PHASE 1 PHASE 2 PHASE 3 UNDER REVIEW MEN'S HEALT
Slide 6: TRT: Significant Market Opportunity
Click to edit Master title style ▪ US market ~ $2 B in 2014 1 ▪ US market ~ 6.5M TRx in 2014 2 • Topicals dominate the market (~86% 2 of $ sales in 2014) ▪ US market estimated ~ 6.0M TRx in 2015 ▪ Oral T expected to expand market ▪ International TRT markets growing 6 TRT: Significant Market Opportun
Slide 7: TRT Monthly TRx Trend
Click to edit Master title style TRT Monthly TRx Trend 7 ▪ To date, minimal TRx impact of FDA TRT label change ▪ 2015 – monthly TRx stable around 500,000/month FDA Label Guidance
Slide 8: TRT: Challenges of Oral T Product
Click to edit Master title style ▪ 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 TRT: Challenges of Oral T Product 8
Slide 9: LPCN 1021 Product Overview: Profile
Click to edit Master title style ▪ Investigational oral product candidate based on unique technology primarily directed at lymphatic delivery of Testosterone Undecanoate (TU), an ester of testosterone ▪ Maintains T blood levels in eugonadal range when dosed twice daily • 88.2% of subjects (efficacy
Slide 10: LPCN 1021 – Current Status
Click to edit Master title style ▪ Filed NDA with the FDA on August 27, 2015 ▪ Met FDA primary efficacy endpoint targets in all data sets in pivotal Phase 3 clinical study ▪ Completed the 52 week safety extension arm • Well tolerated • No cardiac, hepatic, gastrointestinal or drug related SAEs • Ove
Slide 11: Issues with Current TRT Therapies
Click to edit Master title style 11 Issues with Current TRT Therapies Transfer potential to children, partner and pets No freedom to use around pregnant loved ones Skin irritation potential Pulmonary embolism potential Scarring/injection site reactions Risk of infection Not flexible fo
Slide 12: Adherence after Months on Existing Non-Oral TRT Therapies
Click to edit Master title style 12 Adherence after 12 Months on Existing Non - Oral TRT Therapies 1 FDA Advisory Committee Meeting September 17, 2014
Slide 13: LPCN 1021: Compliance Survey
Click to edit Master title style 13 LPCN 1021: Compliance Survey ▪ 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? 94% 0% 6% Yes No Not Sure 1 Lipocine Survey
Slide 14: Meaningful Oral T US Sales Potential
Click to edit Master title style Meaningful Oral T US Sales Potential - A cross a wide range of price and market share assumptions 14 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
Slide 15: LPCN 1021: Phase 3 Primary Efficacy Results
Click to edit Master title style 15 LPCN 1021: Phase 3 Primary Efficacy Results 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 of the pri
Slide 16: LPCN 1021: Phase 3 Secondary Endpoint Results
Click to edit Master title style 16 LPCN 1021: Phase 3 Secondary Endpoint Results Measure FDA Targets Efficacy Population* 1 Number of subjects 151 C max < 1500 ng / dL ≥85% 82.8% 1800 ≤ C max ≤ 2500 ng / dL ≤ 5 % 4.6% C max > 2500 ng / dL None 2.0% x Excessive T repletion outliers ( C max > 2500 ng
Slide 17: LPCN 1021: 52 Week Safety Results
Click to edit Master title style 17 LPCN 1021: 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 activ
Slide 18: LPCN 1021: Dose Adjustments in SOAR Trial
Click to edit Master title style 18 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 89% of LPCN 1021 subjects and 39% of active control subjects (Androgel ® 1.62%) required ≤1 dose adjustment 98% of active control subject
Slide 19: LPCN 1021: T Levels Not Sensitive to Meal Fat Variations
Click to edit Master title style 19 LPCN 1021: T L evels N ot S ensitive to Meal F at V ariations 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 = 15% total calories derived from fat content in the meal; Standard
Slide 20: LPCN 1021: Attributes of Special Interest
Click to edit Master title style LPCN 1021: 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 rel
Slide 21: LPCN 1111 (Next Generation Oral TRT Product Candidate) – Once Daily
Click to edit Master title style ▪ Novel prodrug of testosterone for oral delivery through proprietary drug delivery technology ▪ Once daily is expected to improve and sustain market share of oral T franchise ▪ Once daily feasibility established • Positive Phase 2a study results in hypogonadal men x
Slide 22: LPCN 1111 Phase 2a Study - Responder Analysis
Click to edit Master title style LPCN 1111 Phase 2a Study - Responder Analysis At Day 28 x Once daily dosing feasibility established 22 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
Slide 23: Preterm Birth (PTB) Represents a Significant Unmet Medical Need
Click to edit Master title style ▪ 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 $1 billion market opportunity 5
Slide 24: LPCN 1107: Addresses Unmet Need
Click to edit Master title style ▪ 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%) • LPCN 1107: An oral HPC alternat
Slide 25: LPCN 1107: Clinical Development Overview
Click to edit Master title style 25 LPCN 1107: Clinical Development Overview ▪ 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
Slide 26: LPCN 1107: Phase 1 Study Results
Click to edit Master title style LPCN 1107: Phase 1 Study Results 26 # 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 110
Slide 27: Several Near Term Value Drivers
Click to edit Master title style 27 Compelling Value Proposition: Several Near Term Value Drivers Event Expected Timing LPCN 1021: NDA Acceptance Nov 2015 LPCN 1111: Initiate Phase 2b Study 4Q15 LPCN 1107: Initiate PK Dose Finding Study 4Q15 LPCN 1107: End of Phase 2 Meeting 2Q16 LPCN 1111: End of P
Slide 28: Lipocine is a Compelling Value Proposition
Click to edit Master title style 28 Lipocine is a Compelling Value Proposition Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Closing Stock Price (8/31/15) $13.84/share Market Capitalization (8/31/15) $252.5 million Fully Diluted Shares Outstanding (8/31/15) 19,716,586 Cash Balance (6/30/1
Slide 29: Management and Directors
Click to edit Master title style 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: Pharmacia and U
Slide 30: Investment Highlights
Click to edit Master title style Investment Highlights ▪ Specialty pharma company focused on innovative products for men’s and women’s health ▪ LPCN 1021: Oral testosterone replacement therapy product candidate • Submitted NDA on August 27, 2015 • T argeting ~ $2.0 Billion TRT market ▪ LPCN 1111: Ne