Lipocine Inc. · NASDAQ:LPCN
Lipocine — Annual Canaccord Genuity Growth Conference 2016
21 slides from Lipocine's conference presentation, Aug 10, 2016
Slide 1: Annual Canaccord Genuity Growth Conference 2016 Presentation
Annual Canaccord Genuity Growth Conference 2016 Presentation August 2016 Exhibit 99.1
Slide 2: Forward Looking Statements
Forward Looking Statements 2 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 stat ements re
Slide 3: Lipocine Investment Highlights
Lipocine Investment Highlights 3 ▪ Differentiated product targeting ~$2.0 Billion established US TRT market ▪ Targets unmet need with first entrant advantage ▪ Robust clinical data with branded market leader as active control ▪ LPCN 1111 – Next generation oral TRT option currently in Phase 2b with r
Slide 4: Focused on Innovative Products for Men's and Women's Health
LPCN: Focused on Innovative Products for Men’s and Women’s Health 4 “Transformative“ Oral Testosterone Franchise First Oral Alternative for the Prevention of Pre - Term Birth PRODUCT (Indication) RESEARCH / PRECLINICAL PHASE 1 PHASE 2 PHASE 3 NDA MEN'S HEALTH LPCN 1021 (Oral Testosterone Replacement
Slide 5: Committed to Bringing LPCN 1021 to Patients
LPCN 1021: Committed to Bringing LPCN 1021 to Patients ▪ LPCN 1021 received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) on June 28, 2016 – Deficiency identified relates to the dosing algorithm for the label ▪ The proposed titration scheme in the NDA for clin
Slide 6: TLANDO - First Oral TRT Option: Differentiation vs. Market Leader
TLANDO - First Oral TRT Option 6 D IFFERENTIATION vs. MARKET LEADER ▪ Not prone to accidental T transference ▪ Starting dose is the right dose for most patients ▪ Patient preferred oral option ▪ LPCN 1021 met Primary endpoint: 87% response rate vs. FDA requirement of 75% ▪ Secondary endpoints genera
Slide 7: TRT Market Monthly TRx Trend
2014 2015 Source: IMS Dec. 2015 TRT Market Monthly TRx Trend 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 Monthly TRx (000s) FDA Label Guidance 7 x No TRx imp
Slide 8: Testosterone Replacement Therapy Market
Testosterone Replacement Therapy Market 8 Source: IMS Health Dec 2015 $0.0 $0.5 $1.0 $1.5 $2.0 $2.5 2013 2014 2015 Billions ($) Gross Sales Testosterone - Injectable Depo-Testosterone Testopel Testosterone - Transdermal Fortesta Androderm Testim Axiron AndroGel 1.62% AndroGel 1% 0 1 2 3 4 5 6 7 8 20
Slide 9: Issues with Current TRT Therapies
9 Issues with Current TRT Therapies Transfer potential to children and partner No freedom to use around pregnant loved ones Skin irritation potential Messy to apply and wait to dress Pulmonary embolism potential Pain from injection Needle phobia, needle fatigue Scarring/injection sit
Slide 10: TLANDO (First Oral TRT Option): Why No Oral Product To-Date
TLANDO (First Oral TRT Option): Why No Oral Product To - Date Challenges of Oral T Product ▪ Native testosterone has poor oral bioavailability with a very short half life (~30 min) – Impractical daily doses would be required to obtain effective levels – Inconsistent and unpredictable performance ▪ M
Slide 11: TLANDO: Primary Efficacy Results in Phase 3
11 TLANDO (First Oral TRT Option): Primary Efficacy Results in Phase 3 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% x TLANDO met both
Slide 12: TLANDO: Secondary Endpoints in Phase 3
TLANDO (First Oral TRT Option): Secondary Endpoints in Phase 3 ▪ Proportion of subjects achieving maximum serum total T concentrations (Cmax) in predefined Cmax range 12 Measure FDA Threshold Efficacy Population Number of subjects 151 C max < 1500 ng/ dL ≥ 85 % 82.8% 1800 ≤ C max ≤ 2500 ng/ dL ≤ 5 %
Slide 13: LPCN 1111 - Next Generation Oral TRT Option
LPCN 1111 - Next Generation Oral TRT Option ▪ Novel prodrug of testosterone for oral delivery through proprietary drug delivery technology ▪ Once daily is expected to sustain and improve market share or oral T franchise ▪ Once daily feasibility established – Positive Phase 2a study results in hypogo
Slide 14: LPCN 1111 Phase 2a Study - Responder Analysis
LPCN 1111 Phase 2a Study - Responder Analysis At Day 28 x Once daily dosing feasibility established 14 Measure 550mg QD 770mg QD Typical FDA targets for approval of TRT C avg w ithin normal range 67% 88% ≥ 75% C max < 1500 ng / dL 100% 100% ≥ 85% 1800 ≤ C max ≤ 2500 ng / dL 0% 0% ≤ 5% C max > 2500 n
Slide 15: Preterm Birth Represents a Significant Unmet Medical Need
Preterm Birth (PTB) Represents a Significant Unmet Medical Need ▪ 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 ▪ ≥ $26 billion economic impact: 4
Slide 16: LPCN 1107 (First Oral PTB Candidate): Addresses Unmet Need
LPCN 1107 (First Oral PTB Candidate): “Addresses Unmet Need” 16 ▪ Potential to be the first oral standard - of care therapy – Elimination of 18 - 22 injections – Potential for optimizing clinical outcomes ▪ Orphan drug designation – A major contribution to patient care ▪ Development status – Pivotal
Slide 17: LPCN 1107: Competitive Landscape
LPCN 1107 (First Oral PTB Candidate): Competitive Landscape 17 ▪ Makena® IM injection - only approved product – Viscous oily vehicle – 21 gauge needle – Injection takes up to 1 min – ~35% of patients experienced injection site pain during clinical trial – ~17% of patients reported site swelling - mu
Slide 18: LPCN 1107: Potential to Optimize Clinical Outcomes
LPCN 1107 (First Oral PTB Candidate): Potential to Optimize Clinical Outcomes Limitations of Current Injectable Therapy Potential Advantages of LPCN 1107 18 ▪ Several weeks to get to steady state HPC levels ▪ “One size fits all” fixed single dosing option ▪ Weekly visits to care giver ▪ Steady state
Slide 19: Multiple Near Term Value Drivers
Multiple Near Term Value Drivers 19 Event Expected Timing LPCN 1021: Request End of Review Meeting 3Q16 LPCN 1107: End of Phase 2 Meeting 3Q16 LPCN 1111: Top - line Results from Phase 2b Study 3Q16 LPCN 1021: End of Review Meeting 2H16 LPCN 1111: End of Phase 2 Meeting 4Q16
Slide 20: Lipocine is a Compelling Value Proposition
20 Lipocine is a Compelling Value Proposition Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Closing Stock Price (8/4/16) $3.70/share Market Capitalization (8/4/16) $67.5 million Fully Diluted Shares Outstanding (6/30/16) 20,504,298 Cash Balance (6/30/16) $32.9 million Debt None
Slide 21: Lipocine Investment Highlights
Lipocine Investment Highlights 21 ▪ Differentiated product targeting ~$2.0 Billion established US TRT market ▪ Targets unmet need with first entrant advantage ▪ Robust clinical data with branded market leader as active control ▪ LPCN 1111 – Next generation oral TRT option currently in Phase 2b with
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