Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (June 2017)
41 slides from Lipocine's investor presentation, Jun 28, 2017
Slide 1: Enabling oral drug delivery to improve patient compliance
Enabling oral drug delivery to improve patient compliance CORPORATE PRESENTATION June 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 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) NDA Resubmission 3Q 2017 LPCN 1111 (Next Generation Oral T) End of P2 Meeting 4Q 2017
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 met primary endpoint
• Met primary endpoint: 81% response rate with fixed twice daily (“BID”) dosing regimen vs. FDA requirement of 75% * • Robust efficacy was confirmed with the “worst case” analysis • Secondary endpoints generally consistent with approved products • No eligible subjects * with T levels >2500 ng/ dL •
Slide 11: 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: 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: 1021: Post Action Meeting Regulatory Feedback from FDA
LPCN 1021: Post Action Meeting Regulatory Feedback from FDA • Lipocine proposed 225 mg * BID fixed dose dosing regimen may address the identified titration related label deficiency - Would require clinical validation • “Sponsor should be able to leverage data from the existing trials to help support
Slide 14: 1021: DV and DF Studies Design and Subject Disposition
LPCN 1021: DV and DF Studies Design and Subject Disposition 14 ▪ Open label, fixed dose, single arm studies in adult hypogonadal male subjects treated for 24 days with typical FDA TRT efficacy endpoints - Dosing Validation (DV) study: 450 mg fixed dose divided into two equal doses, 225 mg testostero
Slide 15: 1021: DV Study – Efficacy Results
LPCN 1021: DV Study – 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% * Subjects randomized
Slide 16: 1021: DV Study – Prespecified Secondary Endpoints
LPCN 1021: DV Study – Prespecified Secondary Endpoints Surrogate Safety Indicators Generally Met FDA Targets ▪ Proportion of subjects with T Cmax in predefined ranges against FDA targets (permissible excursions) developed for transdermals - Cmax per dose (highest peak in 12 hrs , each dose) • ≤ 1500
Slide 17: 1021: DV and DF Studies – Adverse Events
LPCN 1021: DV and DF Studies – Adverse Events AE Summary – Well Tolerated • Drug related AEs (ADRs) of 6% and 1% were reported in DV and DF studies, respectively • All ADRs were either mild or moderate and none were severe or serious • Only one subject had a SAE related to gastric ulcer, classified
Slide 18: 1021: Long Term Safety Demonstrated in P3 SOAR Trial
LPCN 1021: Long Term Safety Demonstrated Over 52 Weeks in P3 SOAR Trial 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 19: 1021: Safety Summary
LPCN 1021: Safety Summary Well Tolerated with No Drug Related SAE’s • Total LPCN 1021 exposure in 525 unique patients – Mild to moderate Adverse Drug Reactions (ADRs) – No Drug - Related SAEs – No meaningful changes in critical lab parameters observed • Do Cmax excursions (including deviations from
Slide 20: 1021: Next Steps
LPCN 1021: Next Steps Value Driving Milestones • Planned NDA resubmission in 3Q 2017 • NDA resubmission acceptance (one month post resubmission) – Will indicate whether an FDA Advisory Committee (“ADCOM”) meeting will be required • No ADCOM in original submission • Potential PDUFA date 1Q 2018 20
Slide 21: LPCN 1111
LIPOCIN= LPCN 11117
Slide 22: 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 23: LPCN 1107
LPCN 1107 23
Slide 24: LPCN 1107: Prevention of Preterm Birth (PTB)
24 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 25: High PTB Medical Costs
High PTB Medical Costs 25 ≥ $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 26: 1107: First Oral PTB Candidate Addresses Unmet Need
LPCN 1107: First Oral PTB Candidate 26 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 27: 1107: First Oral PTB Candidate Addresses Unmet Need
LPCN 1107: First Oral PTB Candidate 27 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 28: 1107: HPC PK-PD Correlation
LPCN 1107: HPC PK - PD Correlation 28 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 29: 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 29 PK Study: Oral LPCN 1107 vs IM HPC, Makena Treatment A 400 mg BID Treatment B 600 mg BID
Slide 30: 1107: Dose-Finding PK Study Results
LPCN 1107: Dose - Finding PK Study Results 1 30 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 31: 1107: Development Status
LPCN 1107: Development Status 31 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 32: Upcoming Milestones Driving Value in 2017
Upcoming Milestones Driving Value in 2017 32 Event Expected Timing LPCN 1021: NDA resubmission 3Q 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: Feedback received on P3 protocol submitted via SPA 3Q 2017
Slide 33: Key Financial Metrics
Key Financial Metrics 33 Stock Price, Market Cap, Cash Balance Ticker Symbol LPCN (Nasdaq Capital Market) Closing Stock Price (6/21/17) $4.16/share Market Capitalization (6/21/17) $85.6 million Fully Diluted Shares Outstanding (3/31/17) 21.6 million Cash Balance (3/31/17) $26.8 million Bank Debt (3/
Slide 34: Lipocine Investment Highlights
Lipocine Investment Highlights 34 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 35: Appendix
Appendix 35
Slide 36: 1021: Phase 3 Study of Androgen Replacement (SOAR)
LPCN 1021: Phase 3 Design Study of Androgen Replacement (SOAR) 36 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 37: 1021: DV Study vs SOAR Trial
LPCN 1021: 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 – M
Slide 38: Safety Relevance of LPCN 1021 Cmax Excursions
Safety Relevance of LPCN 1021 Cmax Excursions 38
Slide 39: 1021: DV Study vs SOAR Trial Cmax Outside Pre-defined Ranges
LPCN 1021: DV Study vs SOAR Trial Cmax * Outside the Pre - defined Ranges are Transient 39 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) *
Slide 40: 1021: DV Study Cmax > 1500 ng/dL are Inconsistent
LPCN 1021: DV Study Cmax > 1500 ng/ dL are Inconsistent 40 16 84 0 10 20 30 40 50 60 70 80 90 Both AM and PM Either AM or PM % of Subjects with T Cmax Excursions % of Subjects
Slide 41: 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