Lipocine Inc. · NASDAQ:LPCN
Lipocine — 29th Annual Roth Conference 2017
23 slides from Lipocine's conference presentation, Mar 13, 2017
Slide 1: 29th Annual Roth Conference March 13, 2017
29 th Annual Roth Conference March 13, 2017
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 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 Monthly TRx (000s) FDA Label Guidance TRT Market: Monthly TRx Trend St
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 • 700,000 patients are new to treatment each year 5 Asymtomatic and/or Undiagnosed
Slide 7: Adherence to TRT Treatment Is Poor
Adherence to TRT Treatment Is Poor Median Persistency on a TRT Brand is 3 - 4 Months (~100 Days) 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 AndroGel
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: Physician Market Research
LPCN 1021: Physician Market Research Oral Form Dwarfs Other Attributes in Prescribers’ Mind 10 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 Effe
Slide 11: 1021: Potential First Oral Option Profile Demonstrated Clinically in SOAR Trial
LPCN 1021: Potential First Oral Option Profile Demonstrated Clinically in 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 f
Slide 12: 1021: Path Forward
LPCN 1021: Path Forward Committed to Bringing LPCN 1021 to Patients ▪ Complete Response Letter (CRL) received from FDA on June 28, 2016 ▪ Post Action Meeting Completed: – FDA noted that proposed fixed dose dosing regimen might be acceptable ▪ Fixed dose studies on - going – Open label, fixed dose, s
Slide 13: 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 14: Prevention of Preterm Birth (PTB): An Unmet Medical Need
Prevention of Preterm Birth (PTB) An Unmet Medical Need 14 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 15: 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 16: 1107: First Oral PTB Candidate Addresses Unmet Need
LPCN 1107: First Oral PTB Candidate Addresses Unmet Need 16 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 17: 1107: HPC PK-PD Correlation
LPCN 1107: HPC PK - PD Correlation HPC Concentration and PTB Rate with IM HPC, Makena 1 17 Mean PTB rate with HPC conc. ≥ 8.2 ng/mL: 29.4 % Lower % PTB rate can be expected with daily Cavg 2 HPC levels ≥ 8.2 ng/mL compared to overall PTB rate Total n = 315 Overall mean PTB rate: 33.7 % 46.3 % 27.0 %
Slide 18: 1107: Dose Finding Study Design
LPCN 1107: Dose Finding Study Design PK Study: Oral LPCN 1107 vs IM HPC, Makena 18 ▪ Open - label, four - period, four - treatment study ▪ 12 healthy pregnant women – Age of 18 - 35 years: Screened at gestation age in 16 - 18 weeks Treatment A 400 mg BID Treatment B 600 mg BID Treatment C 800 mg BID
Slide 19: 1107: Dose Finding PK Study Results
LPCN 1107: Dose Finding PK Study Results 1 Oral LPCN 1107 vs IM HPC, Makena 19 ▪ Average HPC levels at target LPCN 1107 Phase 3 dose ~ 3x greater than the comparator, IM HPC, Makena Target Dose Lower reported PTB rate threshold 1. PK results obtained post 8 days of BID dosing for LPCN 1107 and post
Slide 20: 1107: Development Status
LPCN 1107: Development Status 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 treatme
Slide 21: Upcoming Milestones
Upcoming Milestones Near Term Value Drivers Event Expected Timing LPCN 1021: Enrollment complete in DV and DF fixed dose studies Top - line efficacy results from DV and DF fixed dose studies NDA resubmission 2Q17 2Q17 3Q17 LPCN 1111: Preclinical toxicology study End of Phase 2 meeting with FDA 3Q17
Slide 22: Key Financial Metrics
Key Financial Metrics Stock Price, Market Cap, Cash Balance Ticker Symbol LPCN (Nasdaq Capital Market) Closing Stock Price (3/3/17) $4.00/share Market Capitalization (3/3/17) $74.4 million Fully Diluted Shares Outstanding (12/31/16) 20.7 million Cash Balance (12/31/16) $26.8 million Debt None 22
Slide 23: 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