Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (August 2017)
38 slides from Lipocine's investor presentation, Aug 8, 2017
Slide 1: Enabling oral drug delivery to improve patient compliance
Enabling oral drug delivery to improve patient compliance CORPORATE PRESENTATION August 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 statement s re
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 TLANDO™ (LPCN 1021): Potential first oral Testosterone Replacement Therapy option • Differentiated product targeting ~$2.0 Billion establishe
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 TLANDO (Oral Testosterone Replacement Therapy) NDA Resubmission August 2017 LPCN 1111 (Next Generation Oral T) End of P2 Meeting 4Q 201
Slide 5: Hypogonadism Affects Up to 6M 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
2017 2016 2014 2015 350 375 400 425 450 475 500 525 550 575 600 625 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 Jan 17 Feb 17 Mar 17 Apr 17 May 17 J
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: Most Patients Need Dosage Adjustment with Current TRT Options
Most Patients Need Dosage Adjustment with Current TRT Options A Significant Burden with Numerous Doctor Visits 9 40% Other 0 X 47% 1 X 33% 2 X 15% 3 X 2% >3 X 3% 0 X 37% 1 X 26% 2 X 20% 3 X 12% >3 X 5% Number of Current TRT Dose Adjustments by Form* Gel (n=200) Injectable (n=137) * Current TRT n=412
Slide 10: TLANDO
LIPOCIN= TLANDO
Slide 11: TLANDO efficacy and safety summary
• Met primary endpoint: 80% response rate with fixed twice daily (“BID”) dosing regimen vs. FDA requirement of 75% * using baseline carried forward approach with missing data/discontinuances (“worst - case analysis”) • Secondary endpoints generally consistent with approved products • No eligible sub
Slide 12: TLANDO: Patient Market Research
TLANDO: Patient Market Research 12 Patient Enthusiasm Evident About Oral TRT 12 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 TLANDO What Most Like About TLANDO? Other • TLANDO generates
Slide 13: TLANDO: Physician Market Research
TLANDO: Physician Market Research 13 Oral Agent is Most Important Attribute for Prescribers QUESTION: What is the most important advantage of TLANDO? 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 Responde
Slide 14: TLANDO: Development Plan
TLANDO: Development Plan 14 Next Steps to Bring TLANDO to Patients • Dosing Validation (“DV”) clinical study (pivotal efficacy study) results confirm efficacy with no titration – Addresses label titration related deficiency cited in CRL • Study of Oral Androgen Replacement (“SOAR”) Phase 3 clinical
Slide 15: TLANDO: DV Study Efficacy Results
TLANDO: DV Study (Pivotal Efficacy) – Efficacy Results Primary Endpoints – Demonstrated Robust Efficacy Measure FDA Targets Safety Set* “Worst Case” Analysis # Number of subjects 95 95 % subjects with C avg w ithin normal range (300 - 1080 ng/ dL ) ≥75% 81% 80% 95% CI lower bound ≥ 65% 72% 72% * Sub
Slide 16: TLANDO: DV Study Secondary Endpoints
TLANDO: DV Study – Efficacy Results Secondary Endpoints Generally Met FDA Targets ▪ Proportion of subjects with T Cmax in predefined ranges against FDA targets (permissible excursions) that originally developed for transdermals - Key secondary endpoint (> 2500 ng/ dL ) • No trial eligible patient ex
Slide 17: TLANDO: Long Term Safety Demonstrated in SOAR Study
TLANDO: Long Term Safety Demonstrated Over 52 Weeks in SOAR (Pivotal Safety) Study AE’s greater than 5% TLANDO Active Control Upper Respiratory Tract Infection 5.2% 5.8% Fatigue 2.4% 6.7% ADRs greater than 2% TLANDO Active Control Headache 0.5% 2.9% Acne 2.4% 0.0% Safety Population: Subjects who rec
Slide 18: TLANDO: Safety Summary
TLANDO: Safety Summary Well Tolerated with No Drug Related SAE’s • Total TLANDO exposure in 525 unique patients – Mild to moderate Adverse Drug Reactions (ADRs) • Safety relevance of Cmax excursions * – No apparent correlation between observed Cmax excursions >1500 ng/ dL and observed safety paramet
Slide 19: LPCN 1111
LIPOCIN= LPCN 1111
Slide 20: 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 21: LPCN 1107
LPCN 1107 21
Slide 22: LPCN 1107: Prevention of Preterm Birth, An Unmet Medical Need
22 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 23: High PTB Medical Costs
High PTB Medical Costs 23 ≥ $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 24: LPCN 1107: First Oral PTB Candidate Addresses Unmet Need
LPCN 1107: First Oral PTB Candidate 24 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 25: LPCN 1107: First Oral PTB Candidate Addresses Unmet Need
LPCN 1107: First Oral PTB Candidate 25 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 p
Slide 26: LPCN 1107: HPC PK-PD Correlation
LPCN 1107: HPC PK - PD Correlation 26 HPC Concentration and PTB Rate with IM HPC, Makena 1 46.3 % 27.0 % 29.6 % 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 27: 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 27 PK Study: Oral LPCN 1107 vs IM HPC, Makena Treatment A 400 mg BID Treatment B 600 mg BID
Slide 28: LPCN 1107: Dose-Finding PK Study Results
LPCN 1107: Dose - Finding PK Study Results 1 28 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 29: LPCN 1107: Development Status
LPCN 1107: Development Status 29 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, RCT, non - inferiority (“NI”) study with two tr
Slide 30: Upcoming Milestones Driving Value in 2017
Upcoming Milestones Driving Value in 2017 30 Event Expected Timing TLANDO: NDA Resubmission August 2017 Potential PDUFA date 1Q 2018 LPCN 1111: Preclinical toxicology study completion 3Q 2017 End of Phase 2 meeting with FDA 4Q 2017 LPCN 1107: CMC: process characterization & scale - up completed 4Q 2
Slide 31: Key Financial Metrics
Key Financial Metrics 31 Stock Price, Market Cap, Cash Balance Ticker Symbol LPCN (Nasdaq Capital Market) Closing Stock Price (8/4/17) $4.42/share Market Capitalization (8/4/17) $91.4 million Fully Diluted Shares Outstanding (6/30/17) 23.0 million Cash Balance (6/30/17) $27.8 million Bank Debt (6/30
Slide 32: Lipocine Investment Highlights
Lipocine Investment Highlights 32 Innovative Oral Products for Men’s and Women’s Health Proprietary oral drug delivery technology to improve patient compliance TLANDO: Potential first oral Testosterone Replacement Therapy option • Differentiated product targeting ~$2.0 billion established US TRT mar
Slide 33: Appendix
Appendix LIPOCIN=
Slide 34: TLANDO: Phase 3 Study of Androgen Replacement (SOAR) Design
TLANDO: Phase 3 Design Study of Androgen Replacement (SOAR) 34 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 PK/E
Slide 35: TLANDO: DV Study vs SOAR Trial
TLANDO: DV Study vs SOAR Trial Key Design & Efficacy Result Differences DV Study – 225 mg BID without titration – Taken with meal – No BMI restriction – Mean Cavg (CV): 476 ng/ dL (37%)* SOAR Trial – 225 mg BID with titration – Taken with standard (20% – 35% fat) meal – Exclude BMI > 38 kg/m2 – Mean
Slide 36: Safety Relevance of TLANDO Cmax Excursions
Safety Relevance of TLANDO Cmax Excursions 36
Slide 37: TLANDO: DV Study vs SOAR Trial Cmax Outside Pre-defined Ranges
TLANDO: DV Study vs SOAR Trial Cmax * Outside the Pre - defined Ranges are Transient 37 22.3 23.0 21.9 22.0 1.7 1.0 2.1 2.0 0 4 8 12 16 20 24 T Cmax > 1500 ng/dL T Cmax > 1800 ng/dL T Cmax > 1500 ng/dL T Cmax > 1800 ng/dL Time ( hr ) Time Spent in a day below (hr) Time Spent in a day above (hr) *All
Slide 38: Safety Relevance of Cmax > 1500 ng/dL
AE’s greater than 5% in all patients Cmax (ng/dL) > 1500 ≤ 1500 Upper Respiratory Tract Infection 2.6% 5.9% Fatigue 0% 2.5% ADRs greater than 2% in all patients Cmax (ng/dL) > 1500 ≤ 1500 Headache 0% 0.9% Acne 2.6% 0.9% AEs Impact * Cmax on Efficacy day and AEs / ADRs following Efficacy day Safety R