Lipocine Inc. · NASDAQ:LPCN
Lipocine — Piper Jaffray 2015 Healthcare Conference
22 slides from Lipocine's conference presentation, Nov 30, 2015
Slide 1: Piper Jaffray 2015 Healthcare Conference
Piper Jaffray 2015 Healthcare Conference December 2015 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: Focused on Innovative Products for Men's and Women's Health
LPCN: Focused on Innovative Products for Men’s and Women’s Health 3 “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 4: Lipocine Investment Highlights
Lipocine Investment Highlights ▪ Lipocine is well positioned to be a leader in Oral Testosterone – Targeting ~$2.0 Billion TRT US market – Differentiated products – LPCN 1021 has potential to be the first oral treatment option ▪ NDA PDUFA goal date of June 28, 2016 – LPCN 1111 QD option in Phase 2 a
Slide 5: 1021 - First Oral TRT Option (PDUFA Goal Date of June 2016)
LPCN 1021 - First Oral TRT Option (PDUFA Goal Date of June 2016) ▪ NDA Accepted in October 2015 – Targeting Class TRT label – No “black box” warning expected – No Advisory Committee m eeting planned ▪ Potential to be the first approved oral TRT option – Demonstrated efficacy in pivotal Phase 3 clini
Slide 6: TRT Monthly TRx Trend
TRT Monthly TRx Trend 6 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
Slide 7: Issues with Current TRT Therapies
7 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 8: 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) – Impractical daily doses would be required to obtain effective levels – Inconsistent and unpredictable performance – Methyl testosterone – Liver t
Slide 9: Over 47% of Patient Respondents Are Very Likely To Ask About Oral T
Over 47% of Patient Respondents Are Very Likely To Ask About Oral T 14.1 19.2 38.4 32.3 47.5 48.5 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Rx < 6Mo n=99 Current Rx n=412 Percent of Respondents Likelihood to Ask Prescriber About Oral LPCN 1021 Rate 1 - 3 Rate 4 - 7 Rate 8 - 10 Q30. How likely are
Slide 10: 1021 (First Oral TRT Option): Efficacy Results in Phase 3
LPCN 1021 (First Oral TRT Option): “Efficacy Results in Phase 3” 10 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% 81.9% 82.0% x LPCN 1021 met both the primary endpoint t
Slide 11: LPCN 1021: 52 Week Safety Results
11 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 12: 1021 (First Oral TRT Option): 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, or drug related SAEs DHT Levels Compa
Slide 13: LPCN 1021: Efficient Dosing Regimen
13 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 14: Potential for Meaningful Oral T Sales in U.S.
Potential for Meaningful Oral T Sales in U.S. 14 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 introduction and physician “buy and bill” sales) For Ill
Slide 15: 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 16: Preterm Birth (PTB) 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 17: 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 18: 1107 (First Oral PTB Candidate): Status
LPCN 1107 (First Oral PTB Candidate): “Status” 18 ▪ 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 19: 1107 (First Oral PTB Candidate): Phase 1 Study Results
LPCN 1107 (First Oral PTB Candidate): Phase 1 Study Results 19 # 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 20: Several Near Term Value Drivers
Several Near Term Value Drivers 20 Event Expected Timing LPCN 1111: Initiate Phase 2b Study 4Q15 LPCN 1107: Top - line Results from Multi - Dose PK Study 1Q16 LPCN 1111: Top - line Results from Phase 2b Study 1Q16 LPCN 1107: End of Phase 2 Meeting 2Q16 LPCN 1111: End of Phase 2 Meeting 2Q16 LPCN 102
Slide 21: Lipocine is a Compelling Value Proposition
21 Lipocine is a Compelling Value Proposition Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Closing Stock Price (11/20/15) $12.74/share Market Capitalization (11/20/15) $232.5 million Fully Diluted Shares Outstanding (9/30/15) 19,975,030 Cash Balance (9/30/15) $47.8 million Debt None
Slide 22: Lipocine Investment Highlights
Lipocine Investment Highlights ▪ Lipocine is well positioned to be a leader in Oral Testosterone – Targeting ~$2.0 Billion TRT US market – Differentiated products – LPCN 1021 has potential to be the first oral treatment option ▪ NDA PDUFA goal date of June 28, 2016 – LPCN 1111 QD option in Phase 2 a