Slide 1: Corporate Presentation August 2015
Click to edit Master title style Corporate Presentation August 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: First oral testosterone replacement option • On schedule for 2015 NDA submission • T argeting ~ $2.0 Billion TRT market ▪ LPCN 1111: Next generat
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: Compelling Profile
Click to edit Master title style ▪ Novel product based on unique technology primarily directed at lymphatic delivery of Testosterone Undecanoate (TU), an ester of testosterone ▪ Liver safe oral testosterone (T) ▪ Maintains effective T blood levels in eugonadal range when dosed twice daily ▪ Unequivo
Slide 10: LPCN 1021 – On Schedule For 2015 NDA Submission
Click to edit Master title style ▪ Unequivocal efficacy established in pivotal P hase 3 clinical study • Met FDA primary efficacy endpoint targets in all data sets ▪ Completed the 52 week safety extension arm • Well tolerated • No drug related or cardiac related SAEs • Overall AE profile comparable
Slide 11: LPCN 1021: Safer Route of Administration
Click to edit Master title style 11 LPCN 1021: Safer Route of Administration ; 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 flex
Slide 12: LPCN 1021: Life Uninterrupted with Oral T
Click to edit Master title style 12 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 Ret
Slide 13: LPCN 1021: Improved Compliance
Click to edit Master title style 13 LPCN 1021: Improved Compliance ▪ 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 Surve
Slide 14: LPCN 1021: Unequivocal Efficacy in Phase 3
Click to edit Master title style 14 LPCN 1021: Unequivocal Efficacy in Phase 3 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
Slide 15: LPCN 1021: Demonstrated Safety over 52 Weeks
Click to edit Master title style 15 LPCN 1021: Demonstrated Safety over 52 Weeks Dataset: Efficacy population, N=152 ▪ LPCN 1021 was well tolerated during 52 weeks of dosing ▪ No reported hepatic, cardiac or drug - related serious adverse events (SAEs) ▪ Overall adverse event (AE) profile for LPCN 1
Slide 16: LPCN 1021: Efficient Dosing Regimen
Click to edit Master title style 16 41 44 15 2 35 62 0 10 20 30 40 50 60 70 No dose change 1 dose change 2 dose changes % of Subjects LPCN 1021 Active Control ; 85% of LPCN and 37% of active control subjects (Androgel ® 1.62%) required ≤1 dose adjustment ; 98% of active control subjects required a d
Slide 17: LPCN 1021: T Levels Not Sensitive to Meal Fat Variations
Click to edit Master title style 17 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 18: Competitive Environment for Oral Testosterone
Click to edit Master title style 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 LPC
Slide 19: 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 hepatic, cardiac or drug - related SAEs DHT Le
Slide 20: LPCN 1111 (Next Generation Oral TRT Option) – 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 21: 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 21 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
Slide 22: 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 23: LPCN 1107 (First Oral PTB Candidate): 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 24: LPCN 1107: Clinical Development Overview
Click to edit Master title style 24 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 25: LPCN 1107: Phase 1 Study Results
Click to edit Master title style LPCN 1107: Phase 1 Study Results 25 * 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
Slide 26: Compelling Value Proposition: Several Near Term Value Drivers
Click to edit Master title style 26 Compelling Value Proposition: Several Near Term Value Drivers Event Expected Timing LPCN 1021: NDA Filing 2H15 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 Phase 2 M
Slide 27: Lipocine is a Compelling Value Proposition
Click to edit Master title style 27 Lipocine is a Compelling Value Proposition Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Closing Stock Price (7/31/15) $12.36/share Market Capitalization (7/31/15) $218.1 million Fully Diluted Shares Outstanding (7/31/15) 19,716,586 Cash Balance (3/31/1
Slide 28: 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 29: 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: First oral testosterone replacement option • On schedule for 2015 NDA submission • T argeting ~ $2.0 Billion TRT market ▪ LPCN 1111: Next generat