Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (January 2017)
27 slides from Lipocine's investor presentation, Jan 9, 2017
Slide 1: Lipocine - Enhancing Health
Exhibit 99.2 LIPOCINS | v0 ENHANCING HEALTH
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 Investment Highlights
Lipocine Investment 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 cont
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: TRT Market: Current Therapies Have Limitations
TRT Market: Current Therapies Topicals and Injectables Have Limitations 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 X Black Box Warning • Pulmonary oil micro embolism (POME) and
Slide 7: Challenges with Oral TRT
Challenges with Oral TRT LPCN 1021 Designed to Overcome Issues ▪ Native testosterone has poor oral bioavailability with a very short half life (~30 min) – Impractical frequent daily doses would be required to obtain effective levels – Inconsistent and unpredictable performance ▪ Methyl testosterone
Slide 8: 1021: First Oral Option Profile Demonstrated Clinically in SOAR Trial
LPCN 1021: 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 fat content
Slide 9: 1021: Path Forward
LPCN 1021: Path Forward Committed to Bringing 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, single arm
Slide 10: 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 11: 1111: Phase 2b Results / Highlights
LPCN 1111: Phase 2b Results / Highlights Met Primary Study Objectives ▪ Once - daily dose identified for the pivotal Phase 3 study ▪ Target once - daily Phase 3 dose met both primary and secondary end points ▪ Good dose - response relationship was observed ▪ Well tolerated with no drug - related sev
Slide 12: Preterm Birth (PTB): Unmet Need
Preterm Birth (PTB): Unmet Need Billion $ Opportunity ▪ One preterm infant per minute in the U.S. 1 ▪ 11.7% of all US pregnancies 2 result in PTB (< 37 weeks) - a leading cause of neonatal mortality and morbidity 3 ▪ ~10x more first year medical costs are for PTB infants than for full term infants 4
Slide 13: 1107: First Oral PTB Candidate Addresses Unmet Need
LPCN 1107: First Oral PTB Candidate Addresses Unmet Need 13 Makena® - IM HPC LPCN 1107 - Oral HPC * See Appendix for literature on relevance of HPC levels and efficacy • Elimination of 18 - 22 injections • Steady state achieved in 7 days – Enables sooner HPC levels in patients • Orphan drug designat
Slide 14: Preterm Birth Commercial Landscape
Preterm Birth (PTB) Commercial Landscape Competitive Breakout Route - of - administration is an unmet medical need with current treatment options Compounded Hydroxyprogesterone Caproate 37% Makena 1 33% All - Other 30% $1B Market Opportunity 1. AMAG estimates Makena market share based on distributor
Slide 15: 1107: Development Status
LPCN 1107: Development Status End of Phase 2 Meeting and Type C Meeting Complete ▪ Proposed Indication – To reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth ▪ Critical Phase 3 study design input received from FDA: – Agreed
Slide 16: Upcoming Milestones
Upcoming Milestones Near Term Value Drivers Event Expected Timing LPCN 1021: Top - line efficacy results from fixed dose studies ( LPCN 1021 - 16 - 002 (DV Study) and LPCN 1021 - 16 - 003 (DF Study ) ) 2Q17 LPCN 1111: End of Phase 2 meeting with FDA 2H17 LPCN 1107: Submit Phase 3 protocol to FDA via
Slide 17: Key Financial Metrics
Key Financial Metrics Compelling Value Proposition Ticker Symbol LPCN (Nasdaq Capital Market) Closing Stock Price (1/4/17) $3.85/share Market Capitalization (1/4/17) $70.3 million Fully Diluted Shares Outstanding (9/30/16) 20.4 million Cash Balance (9/30/16) $28.8 million Debt None 17
Slide 18: Lipocine Investment Highlights
Lipocine Investment 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 cont
Slide 19: Appendix
Appendix ; COC bis
Slide 20: 1021: Phase 2 Study Design
LPCN 1021: Phase 2 Study Design 20 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 21: 1021: Phase 2 Study Results
LPCN 1021: Phase 2 Study Results Responder Analysis 21 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 22: 1021: Phase 3 Study of Androgen Replacement (SOAR) Design
LPCN 1021: Phase 3 Design Study of Androgen Replacement (SOAR) 22 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 23: 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 24: 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 25: 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 26: Subjects with Cmax > 1500 ng/dL
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
Slide 27: LPCN 1107: HPC Literature Data
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 (%) HPC plasma concentration (ng/mL) LPCN 1107: HPC Literature Data HPC Concentration Versus PTB Rate 27 Source: Cariti