Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (May 2016)
23 slides from Lipocine's investor presentation, May 16, 2016
Slide 1: Corporate Presentation May 2016
Corporate Presentation May 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 - QD oral TRT option currently in Phase 2b ▪ LPCN 1107 Orphan
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 TLANDO™ (LPCN 1021) (Oral T
Slide 5: TLANDO - First Oral TRT Option (PDUFA Goal Date of June 28, 2016)
TLANDO - 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 ▪ Starting
Slide 6: Focus on the Addressable Population
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 Mar 16 Monthly TRx (000s) FDA Label Guidance 8 x No TRx impact of FDA TRT
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) x Median Persistency on a TRT Branded products 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
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: TLANDO: 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 14: TLANDO: Primary Efficacy Results in Phase 3
14 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 15: 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 15 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 16: TLANDO: Attributes of Special Interest
TLANDO (First Oral TRT Option): Attributes of Special Interest 16 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 TLANDO AT
Slide 17: LPCN 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 18: 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 19: LPCN 1107 (First Oral PTB Candidate): Addresses Unmet Need
LPCN 1107 (First Oral PTB Candidate): “Addresses Unmet Need” 19 ▪ 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 20: 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 20 ▪ 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 21: Several Near Term Value Drivers
Several Near Term Value Drivers 21 Event Expected Timing LPCN 1107: Request End of Phase 2 Meeting 2Q16 TLANDO: FDA PDUFA Date June 28, 2016 LPCN 1111: Top - line Results from Phase 2b Study 3Q16 LPCN 1111: End of Phase 2 Meeting 2H16 TLANDO: File NDS in Canada 2H16
Slide 22: Lipocine is a Compelling Value Proposition
22 Lipocine is a Compelling Value Proposition Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Closing Stock Price (5/11/16) $8.01/share Market Capitalization (5/11/16) $146.2 million Fully Diluted Shares Outstanding (3/31/16) 20,504,298 Cash Balance (3/31/16) $38.2 million Debt None
Slide 23: Lipocine Investment Highlights
Lipocine Investment Highlights 23 ▪ 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 - QD oral TRT option currently in Phase 2b ▪ LPCN 1107 Orphan