Lipocine Inc. · NASDAQ:LPCN
Lipocine — 15th Annual Needham Healthcare Conference 2016
21 slides from Lipocine's conference presentation, Apr 12, 2016
Slide 1: 15th Annual Needham Healthcare Conference Presentation April 2016
15 th Annual Needham Healthcare Conference Presentation April 2016 Exhibit 99.2
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 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 Testosterone Repl
Slide 5: LPCN 1021 - First Oral TRT Option
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: 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 7 x No TRx impact of FDA TRT label
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: 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 11: LPCN 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 12: LPCN 1021: Primary Efficacy Results in Phase 3 Trial
12 LPCN 1021 (First Oral TRT Option): Primary Efficacy Results in Phase 3 Trial “Reliably Restores and Maintain Testosterone in Vast Majority of Patients” 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 - 11
Slide 13: LPCN 1021: Attributes of Special Interest
LPCN 1021 (First Oral TRT Option): Attributes of Special Interest 13 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 14: 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 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 – Multi -
Slide 17: LPCN 1107: Single and Multi-dose Study Results
LPCN 1107 (First Oral PTB Candidate): Single and Multi - dose Study Results 17 ▪ Relevant hydroxyprogesterone caproate levels achieved following oral administration ▪ Amenable to therapy improvement ▪ Well - tolerated with no serious adverse events or adverse drug reactions 1 Caritis SN, Venkatarama
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: Several Near Term Value Drivers
Several Near Term Value Drivers 19 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 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 (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 21: 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
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