Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (May 2017)
35 slides from Lipocine's investor presentation, May 26, 2017
Slide 1: Enabling oral drug delivery to improve patient compliance
Enabling oral drug delivery to improve patient compliance INVESTOR PRESENTATION May 2017 Exhibit 99.1
Slide 2: Forward-Looking Statements
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 forward - looking statements rel
Slide 3: Lipocine Investment Highlights
Lipocine Investment Highlights 3 Innovative Oral Products for Men’s and Women’s Health Proprietary oral drug delivery technology to improve patient compliance LPCN 1021: Potential first oral Testosterone Replacement Therapy option • Differentiated product targeting ~$2.0 Billion established US TRT m
Slide 4: Late-Stage Pipeline
4 Late - Stage Pipeline First Oral Products Targeting Significant Opportunities PRODUCT (Indication) RESEARCH / PRECLINICAL PHASE 1 PHASE 2 PHASE 3 NDA MEN’S HEALTH LPCN 1021 (Oral Testosterone Replacement Therapy) Fixed Dose Studies On - Going , Top - line results June ‘17 LPCN 1111 (Next Generatio
Slide 5: Hypogonadism Affects Up to 13M American Men
Hypogonadism Affects Up to 20 M American Men 1,2 5 Significant Number of Untreated Hypogonadal Males ~6M Men with diagnosed hypogonadism 3 2.2M Men currently being treated 4 700,000 New naïve patients each year 5 1. US Census data. http://www.infoplease.com/us/census/data/demographic.html. 2. Mullig
Slide 6: TRT Market: Monthly TRx Trend Stable Following FDA Label Guidance
2016 2014 2015 350 375 400 425 450 475 500 525 550 575 600 Sep 14 Oct 14 Nov 14 Dec 14 Jan 15 Feb 15 Mar 15 Apr 15 May 15 Jun 15 Jul 15 Aug 15 Sep 15 Oct 15 Nov 15 Dec 15 Jan 16 Feb 16 Mar 16 Apr 16 May 16 Jun 16 Jul 16 Aug 16 Sep 16 Oct 16 Nov 16 Dec 16 Monthly TRx (000s) FDA Label Guidance TRT Mar
Slide 7: Unmet Need in TRT Market
Unmet Need in TRT Market x Black Box Warning - Secondary exposure to testosterone x No freedom to use around pregnant loved ones x Skin irritation potential x Messy to apply and wait to dress Limitations with Currently Available Topicals and Injectables x Black Box Warning - Pulmonary oil micro embo
Slide 8: TRT Market: On Therapy Persistency
8 10.90% 23.40% 16.10% 19.20% 36.70% 16.30% 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 Percentage of Patients Remaining “On Therapy” Androderm AndroGel 1.62% Axiron Fortesta Injectables Testim TRT Market: “On Therapy” Persistency Based on New - to
Slide 9: LPCN 1021
LIPOCIN= LPCN 1021
Slide 10: LPCN 1021: Potential First Oral Option Profile Demonstrated in Phase 3 SOAR Trial
• LPCN 1021 met primary endpoint: 87% response rate vs. FDA requirement of 75% * • Secondary endpoints generally consistent with approved products • Cmax excursions were transient * • T levels not affected by food fat content EFFICACY ▪ 52 week long term exposure dataLPCN 1021 met Primary end • 52 w
Slide 11: LPCN 1021: Patient Market Research
LPCN 1021: Patient Market Research 11 Patient Enthusiasm Evident About Oral TRT 11 80% of interviewed TRT patients 30% 30% “Oral Form ” 30% “It’s not Gel”, “ Not Injection” “ Ease of Use” Likely or Highly Likely to Ask Physician to Prescribe LPCN 1021 What Most Like About LPCN 1021? Other • LPCN 102
Slide 12: LPCN 1021: Physician Market Research
LPCN 1021: Physician Market Research 12 Oral Agent is Most Important Attribute for Prescribers QUESTION: What is the most important advantage of LPCN 1021? 66% 10% 8% 8% 5% 3% No/Low Risk of… Good Efficacy Easy Dosing/ Administration Easy/Less Titration Few Side Effects/ Well-tolerated N=212 (All Re
Slide 13: LPCN 1021: Development Plan
LPCN 1021: Development Plan 13 Next Steps to Bring LPCN 1021 to Patients • FDA indicated that proposed fixed dose dosing regimen might be acceptable, pending validation studies RESEARCH Post Complete Response Letter (June ’ 16) Fixed - dose studies on - going (enrollment complete) Next steps: • Open
Slide 14: LPCN 1111
LIPOCIN= LPCN 1111
Slide 15: LPCN 1111: Next-Generation Oral TRT
LPCN 1111: Next - Generation Oral TRT • Novel bio - reversible prodrug of testosterone for oral delivery • Once - daily potential expected to sustain and improve market share of oral T franchise • Once - daily feasibility established in Phase 2a and 2b clinical trials - Single - daily oral dose prov
Slide 16: LPCN 1107
LPCN 1107 16
Slide 17: LPCN 1107: Prevention of Preterm Birth, An Unmet Medical Need
17 1 Pediatric Research (2006) 60, 775 – 776 LPCN 1107: Prevention of Preterm Birth (PTB) An Unmet Medical Need Preterm Birth O week 20 weeks 34 weeks 37 weeks 40 weeks O NE P RETERM B IRTH E VERY M INUTE 1
Slide 18: High PTB Medical Costs
High PTB Medical Costs 18 ≥ $26 billion economic impact 3 • 12% of all US pregnancies 1 (475 - 500K) result in PTB (< 37 weeks) - a leading cause of neonatal mortality and morbidity • First year medical costs for PTB infants are ~ 10x higher than for full term infants 2 • 28% of preterm births are t
Slide 19: LPCN 1107: First Oral PTB Candidate Addresses Unmet Need
LPCN 1107: First Oral PTB Candidate 19 Addresses Unmet Need IM HPC, Makena ® : Current preterm birth standard of care • $334 M in sales in 2016 • Total of 18 - 22 injections – Viscous oily weekly injection – Injection takes up to 1 min – Weekly visit to/by health care provider – ~35% of patients exp
Slide 20: LPCN 1107: First Oral PTB Candidate Addresses Unmet Need
LPCN 1107: First Oral PTB Candidate 20 Addresses Unmet Need LPCN 1107 - Oral HPC • Twice daily dose • Higher HPC levels with Phase 3 target dose vs. IM Injection, Makena • No patient discomfort upon administration • Steady state achieved in 7 days • Orphan drug designation – Major contribution to pa
Slide 21: LPCN 1107: HPC PK-PD Correlation
LPCN 1107: HPC PK - PD Correlation 21 HPC Concentration and PTB Rate with IM HPC, Makena 1 46.3 % 27.0 % 26.9 % 31.3 % Quartile 1: 3.7 - 8.1 ng/mL Quartile 2: 8.2 - 9.8 ng/mL Quartile 3: 9.9 - 12.4 ng/mL Quartile 4: 12.5 - 56 ng/mL 15 25 35 45 55 6 8 10 12 14 16 PTB rate (%, N=315) HPC trough plasma
Slide 22: LPCN 1107: Dose Finding Study Design
LPCN 1107: Dose Finding Study Design • Open - label, four - period, four - treatment study • 12 healthy pregnant women - Ages 18 - 35 years; 16 - 18 weeks gestation • All subjects received all four treatments 22 PK Study: Oral LPCN 1107 vs IM HPC, Makena Treatment A 400 mg BID Treatment B 600 mg BID
Slide 23: LPCN 1107: Dose-Finding PK Study Results
LPCN 1107: Dose - Finding PK Study Results 1 23 Oral LPCN 1107 vs IM HPC, Makena 1. PK results obtained post 8 days of BID dosing for LPCN 1107 and post 5 weeks for weekly IM HPC, Makena Lower reported PTB rate threshold 0 10 20 30 40 50 60 0 200 400 600 800 1000 Cavg(0 - 24/ 0 - 168) (ng/mL) Dose (
Slide 24: LPCN 1107: Development Status
LPCN 1107: Development Status 24 Key Design Elements for Phase 3 Study Proposed indication • To reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth Design Elements • Open label non - inferiority (“NI”) study with two treatmen
Slide 25: Upcoming Milestones Driving Value in 2017
Upcoming Milestones Driving Value in 2017 25 Event Expected Timing LPCN 1021: Top - line efficacy results from DV and DF fixed dose studies June 2017 NDA resubmission 3Q 2017 LPCN 1111: Preclinical toxicology study completion 3Q 2017 End of Phase 2 meeting with FDA 4Q 2017 LPCN 1107: Submit Phase 3
Slide 26: Key Financial Metrics
Key Financial Metrics 26 Stock Price, Market Cap, Cash Balance Ticker Symbol LPCN (Nasdaq Capital Market) Closing Stock Price (5/25/17) $3.64/share Market Capitalization (5/25/17) $70.1 million Fully Diluted Shares Outstanding (3/31/17) 21.6 million Cash Balance (3/31/17) $26.8 million Debt None
Slide 27: Lipocine Investment Highlights
Lipocine Investment Highlights 27 Innovative Oral Products for Men’s and Women’s Health Proprietary oral drug delivery technology to improve patient compliance LPCN 1021: Potential first oral Testosterone Replacement Therapy option • Differentiated product targeting ~$2.0 Billion established US TRT
Slide 28: Appendix
Appendix 28
Slide 29: LPCN 1021: Phase 2 Study Design
LPCN 1021: Phase 2 Study Design 29 Group Dose (mg) (BID) Number of Subjects Sampling Time LPCN 1021 Placebo 1 75 16 4 Intensive PK (0 - 24 hr ) : Day ‘ - 1’ (Baseline), Day 1, 8 and 15 Pre - Dose (Pre - AM, 0hr) : Day 6, 7, 13 and 14 2 150 16 4 3 225 16 4 4 300 9 3 Intensive PK (0 - 24 hr ) : Day ‘
Slide 30: LPCN 1021: Phase 2 Study Results
LPCN 1021: Phase 2 Study Results Responder Analysis 30 1 Groups III and V combined % of Subjects meeting the criteria on Day 15 PK Parameters Criteria / Target 75mg BID 150mg BID 225mg 1 BID 300mg BID N UMBER OF SUBJECTS 16 15 24 9 P RIMARY E ND P OINTS C ave, 0 - 24h 300 - 1140 ng/dL ≥ 75% 44 47 83
Slide 31: LPCN 1021: Phase 3 Study of Androgen Replacement (SOAR) Design
LPCN 1021: Phase 3 Design Study of Androgen Replacement (SOAR) 31 Open - label, randomized, active - controlled study of LPCN 1021 in hypogonadal men Screening N=315 0 Week 4 Week 8 Randomization LPCN 1021 225 mg, TU, BID with Meal (n=210) Active Control (n=105) PK/Dose Titration PK/Dose Titration P
Slide 32: LPCN 1021: SOAR Trial Efficacy Results
LPCN 1021: SOAR Trial Efficacy Results Achieved Primary Endpoint Measure FDA Targets Efficacy Population* 1,2 Full Analysis Set #1 Number of subjects 151 193 % subjects with C avg w ithin normal range (300 - 1140 ng/ dL ) ≥75% 87.4% 87.0% 95 % CI lower bound ≥ 65% 81.7% 82.0% Parameter Mean (CV) Mea
Slide 33: LPCN 1021: SOAR Trial Efficacy Results Secondary Endpoints
LPCN 1021: SOAR Trial Efficacy Results Secondary Endpoints ▪ Proportion of subjects achieving maximum serum total T concentrations (Cmax) in predefined Cmax range Measure FDA Threshold 1 Efficacy Population Number of subjects 151 C max < 1500 ng/ dL ≥ 85 % 82.8% 1800 ≤ C max ≤ 2500 ng/ dL ≤ 5 % 4.6%
Slide 34: LPCN 1021: SOAR Trial Safety Results
LPCN 1021: SOAR Trial Safety Results Demonstrated Safety Over 52 Weeks AE’s greater than 5% LPCN 1021 Active Control Upper Respiratory Tract Infection 5.2% 5.8% Fatigue 2.4% 6.7% ADRs greater than 2% LPCN 1021 Active Control Headache 0.5% 2.9% Acne 2.4% 0.0% Safety Population: Subjects who received
Slide 35: LPCN 1021: SOAR Trial Cmax Excursion Transiency / Impact
Subjects with Cmax > 1500 ng/dL ▪ Cmax excursions following administration of LPCN 1021 are transient / short lived ▪ AE’s are comparable for subjects that have Cmax > 1500 ng/ dL and subjects that have Cmax < 1500 ng/ dL 21.9 hrs 2.1 hrs 0 6 12 18 24 Time below 1500 ng/dL Time above 1500 ng/dL Time