Lipocine Inc. · NASDAQ:LPCN
Lipocine — 16th Annual Needham Healthcare Conference 2017
25 slides from Lipocine's conference presentation, Apr 4, 2017
Slide 1: 16th Annual Needham Healthcare Conference
16 th Annual Needham Healthcare Conference April 4, 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 rela
Slide 3: Lipocine Highlights
Lipocine Highlights Focused on Innovative Products for Men’s and Women’s Health ▪ Differentiated product targeting ~$2.0 Billion established US TRT market ▪ Targets significant unmet need with first entrant advantage ▪ Robust Phase 3 clinical data with branded market leader as active control ▪ Fixed
Slide 4: Late-Stage Pipeline
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) LPCN 1111 (Next Generation Oral T) WOMEN'S HEALTH LPCN 1107 (Prevention of Preterm Birt
Slide 5: 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 6: Hypogonadism Affects Up to Million American Men
Hypogonadism Affects Up to 20 Million American Men 1,2 Significant Number of Untreated Hypogonadal Males 6 Focus on the Addressable Population • Close to 6M men with diagnosed hypogonadism 3 • 2.2M men being treated 4 Asymptomatic and/or Undiagnosed Hypogonadism 70% Diagnosed Untreated 19% 68% 32% T
Slide 7: Median Persistency of Non-Oral is ~100 Days
Median Persistency of Non - Oral is ~100 Days An Oral Product has the Opportunity to Expand the Market 7 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 An
Slide 8: TRT Market: Current Therapies Have Limitations
TRT Market: Current Therapies Topicals and Injectables Have Limitations Black Box Warning • Secondary exposure to testosterone No freedom to use around pregnant loved ones Skin irritation potential Messy to apply and wait to dress Black Box Warning • Pulmonary oil micro embolism (POME) and
Slide 9: 1021: Patient Market Research
LPCN 1021: Patient Market Research Patient Enthusiasm Evident About Oral TRT 9 80% of interviewed TRT patients 30% “Oral Form ” 30% ▪ LPCN 1021 generates strong patient enthusiasm among current and prior TRT users – Oral administration and lack of transference viewed as key benefits ▪ For transderma
Slide 10: 1021: Patient Market Research - Dosage Adjustment
LPCN 1021: Patient Market Research Most Patients Need Dosage Adjustment with Current TRT Options 10 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, TVG conduct
Slide 11: 1021: Physician Market Research
LPCN 1021: Physician Market Research Oral Agent is Most Important Attribute in Prescribers’ Mind 11 40% Other Oral Agent QUESTION: What is the most important advantage of LPCN 1021? 66% 10% 8% 8% 5% 3% No/Low Risk of Transference Good Efficacy Easy Dosing/ Administration Easy/Less Titration Few Side
Slide 12: 1021: Potential to Become the Future Market Leader
LPCN 1021: Potential to Become the Future Market Leader* Addresses Limitations of Existing TRT Options 12 * Subject to FDA approval and final product labeling language No Wait to Embrace Life No Dose Reversibility Issue No Injection Pain No Injection Site Reaction No Cardiac, Hepatic, GI, or Drug -
Slide 13: 1021: Potential First Oral Option Profile Demonstrated Clinically in SOAR Trial
LPCN 1021: Potential First Oral Option Profile Demonstrated Clinically in SOAR Trial ▪ 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 EFF
Slide 14: 1021: Path Forward
LPCN 1021: Path Forward Committed to Bringing LPCN 1021 to Patients ▪ Post CRL, FDA noted that proposed fixed dose dosing regimen might be acceptable, but would need to validate with a study ▪ Fixed dose studies on - going (enrollment expected to be complete 2Q 2017) – Open label, fixed dose, single
Slide 15: 1111: Next Generation Oral TRT
LPCN 1111: Next Generation Oral TRT Potential Once - Daily Dosing ▪ 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 – Sin
Slide 16: Prevention of Preterm Birth: An Unmet Medical Need
Prevention of Preterm Birth (PTB) An Unmet Medical Need 16 O NE P RE T ERM B I RTH E VERY M I NUTE 1 Pre Term Birth O week 20 weeks 34 weeks 37 weeks 40 weeks 1 Pediatric Research (2006) 60, 775 – 776
Slide 17: Medical Costs of PTB are Significant
Medical Costs of PTB are Significant Billion $ Opportunity ▪ 11.7% of all US pregnancies 1 result in PTB (< 37 weeks) - a leading cause of neonatal mortality and morbidity 2 ▪ ~10x more first year medical costs are for PTB infants than for full term infants 3 ▪ ≥ $26 billion economic impact: 3 $1 bi
Slide 18: 1107: First Oral PTB Candidate Addresses Unmet Need
LPCN 1107: First Oral PTB Candidate Addresses Unmet Need 18 IM HPC, Makena® LPCN 1107 - Oral HPC ▪ Higher HPC levels with Phase 3 target dose vs. IM Injection, Makena ▪ Steady state achieved in 7 days ▪ Orphan drug designation – Major contribution to patient care ▪ Total of 18 - 22 injections – Visc
Slide 19: LPCN 1107: HPC PK-PD Correlation
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 concentration (ng/mL) LPCN 1107: HPC PK - PD Correlation HPC Concentration and PTB Rate wi
Slide 20: 1107: Dose Finding Study Design
LPCN 1107: Dose Finding Study Design PK Study: Oral LPCN 1107 vs IM HPC, Makena 20 ▪ 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 Treatment A 400 mg BID Treatment B 600 mg BID
Slide 21: 1107: Dose Finding PK Study Results
LPCN 1107: Dose Finding PK Study Results 1 Oral LPCN 1107 vs IM HPC, Makena 21 Lower reported PTB rate threshold 1. PK results obtained post 8 days of BID dosing for LPCN 1107 and post 5 weeks for weekly IM HPC, Makena ▪ HPC levels below 8.2 ng/mL: – Target LPCN 1107 Phase 3 dose = 0% – IM HPC, Make
Slide 22: 1107: Development Status
LPCN 1107: Development Status Key Design Elements for Phase 3 Study ▪ Proposed indication: Same Active, Same Indication as Standard of Care, Makena® ▪ A single study may suffice for Subpart H approval ▪ Design elements - Randomized Controlled Non - inferiority (“NI”) Trial – Two treatment arms (LPCN
Slide 23: Upcoming Milestone Events
Upcoming Milestone 23 Event Expected Timing LPCN 1021: Enrollment complete in DV and DF fixed dose studies 2Q 2017 Top - line efficacy results from DV and DF fixed dose studies 2Q 2017 NDA resubmission 3Q 2017 LPCN 1111: Preclinical toxicology study 3Q 2017 End of Phase 2 meeting with FDA 2H 2017 LP
Slide 24: Key Financial Metrics
Key Financial Metrics Stock Price, Market Cap, Cash Balance Ticker Symbol LPCN (Nasdaq Capital Market) Closing Stock Price (3/20/17) $4.46/share Market Capitalization (3/20/17) $85.9 million Fully Diluted Shares Outstanding (12/31/16) 20.7 million Cash Balance (12/31/16) $26.8 million Debt None 24
Slide 25: Lipocine Highlights
Lipocine Highlights Focused on Innovative Products for Men’s and Women’s Health ▪ Differentiated product targeting ~$2.0 Billion established US TRT market ▪ Targets significant unmet need with first entrant advantage ▪ Robust Phase 3 clinical data with branded market leader as active control ▪ Fixed
Lipocine — 16th Annual Needham Healthcare Conference 2017 on 6ix