Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (April 2016)
27 slides from Lipocine's investor presentation, Apr 12, 2016
Slide 1: Corporate Presentation April 2016
Corporate Presentation April 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 First oral TRT option under FDA review with a PDUFA goal date of June 28, 2016 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 contr
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 UNDER REVIEW MEN'S HEALTH LPCN 1021 (Oral Testosteron
Slide 5: 1021 - First Oral TRT Option (PDUFA Goal Date of June 28, 2016)
LPCN 1021 - First Oral TRT Option (PDUFA Goal Date of June 28, 2016) ▪ NDA accepted in October 2015 – Targeting Class TRT label – No “black box” warning expected ▪ Potential to be the first approved oral TRT option 5 D IFFERENTIATION vs. MARKET LEADER ▪ Not prone to accidental T transference ▪ Start
Slide 6: Hypogonadism Affects Up to 20 Million American Men
Undiagnosed Hypogonadism 70% Diagnosed Untreated 19% 68% 23% Treated 11% Treatment-experienced Treatment-naïve ▪ Close to 6M men with diagnosed hypogonadism 3 ▪ 2.2M men being treated 4 ▪ 700,000 patients are new to treatment each year 5 1 US Census data. http://www.infoplease.com/us/census/data/dem
Slide 7: The Majority of TRT Patients Suffer from At Least One Other Co-morbidity
46% 34% 28% 28% 26% 20% 17% 16% 11% 2% 11% Erectile dysfunction Obesity Hypertension Hyperlipidemia Diabetes Depression Sleep apnea Coronary artery disease Chronic pain treated w/opioids HIV/AIDs No co - morbidities % of TRT Patients n=212 (All Respondents; URO=54, ENDO=53, PCP=105) Q4. What percent
Slide 8: 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 Monthly TRx (000s) FDA Label Guidance 8 x No TRx impact of FDA TRT label
Slide 9: Testosterone Replacement Therapy Market
Testosterone Replacement Therapy Market 9 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 10: Issues with Current TRT Therapies
10 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 si
Slide 11: Adherence to TRT Treatment Is Poor
TRT Market: “On Therapy” Persistency Based on New - to - Market Cohorts (July 2013) Median Persistency on a TRT Brand is 3 - 4 Months (~100 Days) MABI’s TRT Patient Metrics (Powered by Source Healthcare Analytics Patient Data). All trademarks acknowledged. Adherence to TRT Treatment Is Poor 10.90% 2
Slide 12: NIH "T Trial" Study Results
NIH “T Trial” Study 1 Results ▪ Symptomatic men of ≥ 65 years of age, raising T concentrations for one year from moderately low to the mid - normal range (as typical observed for young adult men) – Moderate benefit with respect to sexual function – Some benefit with respect to mood and depressive sy
Slide 13: 1021: First Oral TRT Option
LPCN 1021: First Oral TRT Option 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 – Methyl testosterone ▪ Liver to
Slide 14: LPCN 1021: Primary Efficacy Results in Phase 3
14 LPCN 1021 (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 LPCN 1021 me
Slide 15: 1021: Secondary Endpoints in Phase 3
LPCN 1021 (First Oral TRT Option): Secondary Endpoints in Phase 3 ▪ Proportion of subjects achieving maximum serum total T concentrations (Cmax) in predefined Cmax range 15 Measure FDA Threshold Efficacy Population Number of subjects 151 C max < 1500 ng/ dL ≥ 85 % 82.8% 1800 ≤ C max ≤ 2500 ng/ dL ≤
Slide 16: 1021: Efficient Dosing Experience
LPCN 1021 (First Oral TRT Option): Efficient Dosing Experience 1 1 LPCN 1021 Phase 3 (SOAR) Trial results 11% 61% LPCN 1021 Active Control 41% 48% 11% 0 1 2 Patients (%) Requiring >1 Dose Adjustment Number of Dose Titrations Required (% of patients) Active Control - Market Leader T gel 3% 36% 61% 0
Slide 17: 1021: Attributes of Special Interest
LPCN 1021 (First Oral TRT Option): Attributes of Special Interest 17 Efficacy Robust to Sensitivity Analysis No cardiac, hepatic or drug related SAE Comparable to Active Control No Change from Baseline Mean Maintenance Dose Comparable to Starting Dose T Levels not Sensitive to Fat Content Yes LPCN 1
Slide 18: 1111 (Next Generation Oral TRT Option): Once Daily
LPCN 1111 (Next Generation Oral TRT Option): “Once Daily” ▪ 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 res
Slide 19: 1111: Study Design
LPCN 1111 (Next Generation Oral TRT Option): Study Design 19 ▪ Open label, two - period, multiple dose PK study ▪ 36 hypogonadal males ▪ Three dose levels of LPCN 1111 in Period 1 (500mg, 750mg, and 1000mg) ▪ Two dose levels of LPCN 1111 in Period 2 (250mg QD or 1250mg QD, 500mg BID) ▪ Subjects (36)
Slide 20: 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 21: Preterm Birth Ranking - Worldwide
Preterm Birth Ranking – Worldwide 1 21 1 Blencowe H, Cousens S, Oestergaard M, Chou D, Moller AB, Narwal R, Adler A, Garcia CV, Rohde S, Say L, Lawn JE. National, regional and worldwide estimates of preterm birth. The Lancet, June 2012. 9;379(9832):2162 - 72. Estimates from 2010.
Slide 22: 1107 (First Oral PTB Candidate): Addresses Unmet Need
LPCN 1107 (First Oral PTB Candidate): “Addresses Unmet Need” 22 ▪ 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 – Multi -
Slide 23: 1107: Single and Multi-dose Study Results
LPCN 1107 (First Oral PTB Candidate): Single and Multi - dose Study Results 23 ▪ Relevant hydroxyprogesterone caproate levels achieved following oral administration – Average steady state HPC levels (Cavg0 - 24) were comparable or higher for all three LPCN 1107 doses than for injectable HPC – Previo
Slide 24: 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 24 ▪ 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 25: Several Near Term Value Drivers
Several Near Term Value Drivers 25 Event Expected Timing LPCN 1107: Request End of Phase 2 Meeting 2Q16 LPCN 1021: FDA PDUFA Date June 28, 2016 LPCN 1111: Top - line Results from Phase 2b Study 3Q16 LPCN 1111: End of Phase 2 Meeting 2H16 LPCN 1021: File NDS in Canada 2H16
Slide 26: Lipocine is a Compelling Value Proposition
26 Lipocine is a Compelling Value Proposition Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Closing Stock Price (4/6/16) $12.38/share Market Capitalization (4/6/16) $226.0 million Fully Diluted Shares Outstanding (12/31/15) 19,975,030 Cash Balance (12/31/15) $44.8 million Debt None
Slide 27: Lipocine Investment Highlights
Lipocine Investment Highlights First oral TRT option under FDA review with a PDUFA goal date of June 28, 2016 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 contr