Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (October 2015)
30 slides from Lipocine's investor presentation, Oct 13, 2015
Slide 1: Corporate Presentation October 2015
Corporate Presentation October 2015 Exhibit 99.1
Slide 2: Lipocine Investment Highlights
Lipocine Investment Highlights ▪ First oral testosterone replacement option – Targeting ~ $2.0 Billion TRT market – NDA submitted August 2015 – Differentiated from existing products ▪ Orphan designated oral alternative for the prevention of preterm birth – A voids painful injections of the only FDA
Slide 3: Lip'ral Enables Optimal Dispersion in the Gastrointestinal Tract
Lip’ral Enables Optimal Dispersion in the Gastrointestinal Tract Improved absorption Effective transfer across aqueous barrier layer Optimal dispersed phase in GI tract Insoluble drug lipidic composition 3
Slide 4: Focused on Innovative Products for Men's and Women's Health
4 LPCN: Focused on Innovative Products for Men’s and Women’s Health “Transformative“ Oral Testosterone Franchise First Oral Alternative for the Prevention of Pre - Term Birth PRODUCT (Indication) RESEARCH / PRECLINICAL PHASE 1 PHASE 2 PHASE 3 UNDER REVIEW MEN'S HEALTH LPCN 1021 ( Oral Testosterone R
Slide 5: LPCN 1021 - First Oral TRT Option (NDA Submitted)
LPCN 1021 - First Oral TRT Option (NDA Submitted) ▪ Robust efficacy established in pivotal P hase 3 clinical study – Met FDA primary efficacy endpoint targets ▪ Completed the 52 week safety extension arm – Well tolerated ▪ Overall AE profile comparable to active control, Androgel ® 1.62% (market lea
Slide 6: TRT Treated Patients
TRT Treated Patients 6 Symphony Healthcare Solutions extracted May 2014 for FDA Advisory meeting 1.2M 1.5 2.0 2.2 2.0 0 500000 1000000 1500000 2000000 2500000 2010 2011 2012 2013 2014 Male Testosterone Patients Male T Pts Treatment Rate x Treated patients rates declined in 2014 due primarily to an e
Slide 7: Dollar Sales in the TRT Market Remain Dominated by Gels
Dollar Sales in the TRT Market Remain Dominated by Gels 7 IMS Health Sept 2015 $0.0 $0.5 $1.0 $1.5 $2.0 $2.5 2013 2014 2015 Estimate Billions ($) Gross Sales Testosterone - Injectable Depo-Testosterone Testopel Testosterone - Transdermal Fortesta Androderm Testim Axiron AndroGel 1.62% AndroGel 1% 0
Slide 8: TRT Monthly TRx Trend
TRT Monthly TRx Trend 8 x To date, minimal TRx impact of FDA TRT label change x 2015 – monthly TRx stable around 500,000/month 1 IMS Data FDA Label Guidance - 100,000 200,000 300,000 400,000 500,000 600,000 Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 TRT TRx's TRx
Slide 9: LPCN 1021 - First Oral TRT Option: Challenges of Oral T
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) – Multiple daily doses would be required to obtain effective levels ▪ Methyl testosterone – Liver toxicity – Unsafe for chronic use LPCN 1021 adva
Slide 10: Issues with Current TRT Therapies
10 Issues with Current TRT Therapies Transfer potential to children, partner and pets No freedom to use around pregnant loved ones Skin irritation potential Pulmonary embolism potential Scarring/injection site reactions Risk of infection Not flexible for dose reversals Topicals Invasives
Slide 11: Adherence after Months on Existing Non-Oral TRT Therapies
Adherence after 12 Months on Existing Non - Oral TRT Therapies 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% M+1 M+2 M+3 M+4 M+5 M+6 M+7 M+8 M+9 M+10 M+11 M+12 Percent of Patients Remaining “On Therapy” TRT Market: “On Therapy” Persistency Based on New - to - Market Cohorts (July 2013) Androderm Andro
Slide 12: LPCN 1021: Compliance Survey
12 LPCN 1021 (First Oral TRT Option): Compliance Survey ▪ Survey of 28 leading endocrinologists and urologists about oral testosterone compliance 1 • In your opinion, will oral testosterone improve patient compliance compared to existing options? 94% 0% 6% Yes No Not Sure 1 Lipocine Survey 2014
Slide 13: LPCN 1021 Product Overview: Profile
▪ Investigational oral product candidate based on unique technology primarily directed at lymphatic delivery of Testosterone Undecanoate (TU), an ester of testosterone ▪ Maintains T blood levels in eugonadal range when dosed twice daily – 87.4% of subjects (efficacy population) in SOAR trial had C a
Slide 14: LPCN 1021: Phase 3 Primary Efficacy Results
14 LPCN 1021 (First Oral TRT Option): Phase 3 Primary Efficacy Results Measure FDA Targets Efficacy Population* 1 Full Analysis Set #1 Number of subjects 151 193 % subjects with C avg w ithin normal range ≥75% 87.4% 87.0% 95 % CI lower bound ≥ 65% 81.7% 82.0% x LPCN 1021 met both of the primary endp
Slide 15: LPCN 1021: Phase 3 Secondary Endpoint Results
15 LPCN 1021 (First Oral TRT Option): Phase 3 Secondary Endpoint Results Measure FDA Targets Efficacy Population* 1 Number of subjects 151 C max < 1500 ng / dL ≥85% 82.8% 1800 ≤ C max ≤ 2500 ng / dL ≤ 5 % 4.6% C max > 2500 ng / dL None 2.0% x Excessive T repletion outliers ( C max > 2500 ng / dL ) w
Slide 16: LPCN 1021: 52 Week Safety Results
16 LPCN 1021 (First Oral TRT Option): 52 Week Safety Results ▪ LPCN 1021 was well tolerated during 52 weeks of dosing ▪ No reported cardiac, hepatic or drug related serious adverse events (SAEs) ▪ Overall adverse event (AE) profile for LPCN 1021 was comparable to the active control, Androgel ® 1.62%
Slide 17: LPCN 1021: T Levels Not Sensitive to Meal Fat Variations
LPCN 1021 (First Oral TRT Option): “ T Levels N ot S ensitive T o M eal F at Variations” 17 0 500 1000 1500 2000 2500 0 4 8 12 16 20 24 Mean (+SD) Serum T Concentration (ng/dL) Time (hr) Low Fat Standard Fat High Fat 1 Low Fat = About 15% total calories derived from fat content in the meal; Standard
Slide 18: LPCN 1021: Efficient Dosing Regimen
18 41 48 11 2 37 61 0 10 20 30 40 50 60 70 No dose change 1 dose change 2 dose changes % of Subjects LPCN 1021 Active Control x 89% of LPCN and 39% of active control subjects (Androgel® 1.62%) required ≤1 dose adjustment x Almost all subjects on active control, the market leader, required a titratio
Slide 19: LPCN 1021: Attributes of Special Interest
LPCN 1021 (First Oral TRT Option): Attributes of Special Interest Attributes LPCN 1021 Efficacy Robust to Sensitivity Analysis Consistent Inter - day / Intra - day Performance Yes Meal Fat E ffect T levels not sensitive to fat content Safety No cardiac, hepatic, gastrointestinal or drug related SAEs
Slide 20: Meaningful Oral T US Sales Potential
Meaningful Oral T US Sales Potential - A cross a wide range of price and market share assumpti ons 20 Market Share Sales Potential ( in M) Assumptions: • $400/Rx current TRT Branded pricing; • 6 Million Annual US TRT TRx (excludes ex - US, expansion due to improved Rx retention rates due to oral int
Slide 21: 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 improve and sustain market share or oral T franchise ▪ Once daily feasibility established – Positive Phase 2a study res
Slide 22: LPCN 1111 Phase 2a Study - Responder Analysis
LPCN 1111 Phase 2a Study - Responder Analysis At Day 28 x Once daily dosing feasibility established 22 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 23: Preterm Birth 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 $1 billion market opportunity 5 23 Preterm Birth (PTB) Represent
Slide 24: LPCN 1107 (First Oral PTB Candidate): Addresses Unmet Need
LPCN 1107 (First Oral PTB Candidate): “Addresses Unmet Need” ▪ The only FDA approved product for the prevention of PTB is an injectable hydroxyprogesterone caproate (HPC) ▪ Issues with the injectable HPC: – Weekly injection in doctor’s office or home – Injection site pain (35%), swelling (17%) • LPC
Slide 25: LPCN 1107 (First Oral PTB Candidate): Status
LPCN 1107 (First Oral PTB Candidate): “Status” 25 ▪ Potential to be the first oral standard - of care therapy • Elimination of 18 - 22 injections ▪ Orphan drug designation • A major contribution to patient care ▪ Oral feasibility established • Successful Phase 1 studies in healthy non - pregnant wom
Slide 26: LPCN 1107: Phase 1 Study Results
LPCN 1107 (First Oral PTB Candidate): Phase 1 Study Results 26 # AUCss calculated for post steady state 1 week duration Study population (N) AUC SS ( ng.h /ml) # Relative bioavailability [400 mg BID oral / IM ] Relative bioavailability [800 mg BID oral / IM] LPCN 1107/ 400 mg BID Oral LPCN 1107/ 800
Slide 27: Several Near Term Value Drivers
Several Near Term Value Drivers 27 Event Expected Timing LPCN 1021: Anticipated NDA 74 day letter November 2015 LPCN 1111: Initiate Phase 2b Study 4Q15 LPCN 1107: Top - line Results for Multi - Dose PK Study 1Q16 LPCN 1107: End of Phase 2 Meeting 2Q16 LPCN 1111: End of Phase 2 Meeting 2Q16 LPCN 1021
Slide 28: Lipocine is a Compelling Value Proposition
28 Lipocine is a Compelling Value Proposition Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Closing Stock Price (10/12/15) $12.94/share Market Capitalization (10/12/15) $236.1 million Fully Diluted Shares Outstanding (10/12/15) 19,716,586 Cash Balance (6/30/15) $53.4 million Debt None
Slide 29: Management and Directors
Management Directors Mahesh Patel, Ph.D Chairman, President and Chief Executive Officer ▪ 20+ years of technology and product development experience in the area of drug discovery support, drug delivery and product line extensions ▪ Prior Affiliations: Pharmacia and Upjohn Morgan Brown, MBA, CPA Exec
Slide 30: Lipocine Investment Highlights
Lipocine Investment Highlights ▪ First oral testosterone replacement option – Targeting ~ $2.0 Billion TRT market – NDA submitted August 2015 – Differentiated from existing products ▪ Orphan designated oral alternative for the prevention of preterm birth – A voids painful injections of the only FDA