Lipocine Inc. · NASDAQ:LPCN
Lipocine — JMP Securities Conference 2015
22 slides from Lipocine's conference presentation, Jun 23, 2015
Slide 1: JMP Securities Conference
Click to edit Master title style JMP Securities Conference June 23, 2015 Exhibit 99.1
Slide 2: Forward Looking Statements
Click to edit Master title style 2 Forward Looking Statements 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
Slide 3: Lipocine Corporate Highlights
Click to edit Master title style ▪ Focused on innovative products for men’s and women’s health 3 Lipocine Inc. (LPCN) – Corporate Highlights “Transformative“ Oral Testosterone Franchise First Oral Alternative for the Prevention of Pre - Term Birth PRODUCT (Indication) RESEARCH / PRECLINICAL PHASE 1
Slide 4: Lipocine Investment Thesis
Click to edit Master title style Lipocine Investment Thesis ▪ First oral testosterone replacement option on schedule for 2015 NDA submission targeting ~ $2.0 Billion TRT market ▪ First orphan designated oral alternative for the prevention of preterm birth that avoids painful injections of the only F
Slide 5: LPCN 1021 – On Schedule For 2015 NDA Submission
Click to edit Master title style ▪ Unequivocal efficacy established in pivotal P hase 3 clinical study • Met FDA primary efficacy endpoint targets in safety set ▪ Successfully completed Pre - NDA meeting • No additional studies required for filing ▪ Completed the 52 week safety extension arm • Top l
Slide 6: Existing Testosterone Treatment Options Are Inadequate
Click to edit Master title style ▪ Issues with current TRT options • Topicals x Transference issue, black box warning x Poor compliance: 86% discontinue by 12 months 1 • Invasives ( injectables , pellets) x Excessive androgenic levels x Potential pulmonary embolism x Injection site reaction/scarring
Slide 7: Testosterone Replacement Therapy Market: Large Market Opportunity
Click to edit Master title style ▪ US market ~ $2 B in 2014 1 ▪ US market ~ 6.5M TRx in 2014 2 • Topicals dominate the market (~86% 2 of $ sales in 2014) ▪ US market estimated ~ 6.0M TRx in 2015 • To date, minimal TRx impact of FDA TRT label change • 2015 – monthly TRx stable around 500,000/month ▪
Slide 8: What Is LPCN 1021?
Click to edit Master title style ▪ Novel product based on unique technology primarily directed at lymphatic delivery of Testosterone Undecanoate (TU), an ester of testosterone ▪ Liver safe oral testosterone (T) ▪ Maintains effective T blood levels in eugonadal range when dosed twice daily 8 LPCN 102
Slide 9: Compelling Clinical Profile
Click to edit Master title style ▪ Unequivocal efficacy results ▪ Patient and payer friendly dosing regimen ▪ T levels not sensitive to meal fat variations ▪ Consistent intra - day and inter - day performance ▪ No drug or cardiac related SAEs reported upon 52 week exposure • No reports of stroke, my
Slide 10: Unequivocal Efficacy in Phase 3
Click to edit Master title style 10 LPCN 1021 (First Oral TRT Option): “Unequivocal Efficacy in Phase 3” Measure FDA Targets Efficacy Population* 1 Full Analysis Set #1 Number of subjects 152 192 % subjects with C avg w ithin normal range ≥75% 88.2% 87.5% 95 % CI lower bound ≥ 65% 81.9% 82.0% x LPCN
Slide 11: Friendly Dosing Regimen
Click to edit Master title style 11 LPCN 1021 (First Oral TRT Option): “Friendly Dosing Regimen” Dataset: Efficacy population, N=152 Parameter % of subjects % subjects requiring no more than one dose change (either after week 3 or week 7) 85% % subjects requiring two dose changes (both after week 3
Slide 12: T levels not sensitive to meal fat variations
Click to edit Master title style 12 LPCN 1021 (First Oral TRT Option): “ T levels not sensitive to meal fat variations” Mean SD Total Testosterone Concentration Under Fed Conditions 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 Hi
Slide 13: A Safer Route of Administration
Click to edit Master title style 13 LPCN 1021 (First Oral TRT Option): “A Safer Route of Administration” X Transfer potential to children, partner and pets X No freedom to use around pregnant loved ones X Skin irritation potential X Pulmonary embolism potential X Scarring/injection site reactions X
Slide 14: Life Uninterrupted with Oral T
Click to edit Master title style 14 LPCN 1021 (First Oral TRT Option): “Life Uninterrupted with Oral T” x Discrete x No waiting • Prior to dressing • In doctor’s office x Suitable for “on the go” use x No shower/swim restrictions x No mess/clean up x Non - invasive Improved Compliance Convenience En
Slide 15: Improved Compliance
Click to edit Master title style 15 LPCN 1021 (First Oral TRT Option): “Improved Compliance” ▪ 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
Slide 16: LPCN 1111 (Next Generation Oral TRT Option) – Once Daily
Click to edit Master title style ▪ 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 results in hypogonadal men x
Slide 17: Preterm Birth Represents a Significant Unmet Medical Need
Click to edit Master title style ▪ 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
Slide 18: LPCN 1107 (First Oral PTB Candidate): Addresses Unmet Need
Click to edit Master title style ▪ 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%) • LPCN 1107: An oral HPC alternat
Slide 19: LPCN 1107 (First Oral PTB Candidate): Status
Click to edit Master title style 19 LPCN 1107 (First Oral PTB Candidate): “Status” ▪ 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 stud
Slide 20: Several Near Term Value Drivers
Click to edit Master title style Compelling Value Proposition: “Several Near Term Value Drivers” 20 1Q 2015 2Q 2015 3 Q 2015 4 Q 2015 4 Q 2016 LPCN 1021: 1 Year Safety Data LPCN 1107: Initiate PK Dose Finding Study LPCN 1021: File NDA LPCN 1111: Initiate Phase 2b Study 2Q 2016 3 Q 2016 1Q 2016 LPCN
Slide 21: Lipocine is a Compelling Value Proposition
Click to edit Master title style 21 Lipocine is a Compelling Value Proposition Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Closing Stock Price (6/19/15) $8.00/share Market Capitalization (6/19/15) $140.0 million Fully Diluted Shares Outstanding (6/19/15) 19,716,586 Cash Balance (3/31/14
Slide 22: Lipocine Investment Thesis
Click to edit Master title style Lipocine Investment Thesis ▪ First oral testosterone replacement option on schedule for 2015 NDA submission targeting ~ $2.0 Billion TRT market ▪ First orphan designated oral alternative for the prevention of preterm birth that avoids painful injections of the only F