Lipocine Inc. · NASDAQ:LPCN
Lipocine — Canaccord Genuity Growth Conference 2015
25 slides from Lipocine's conference presentation, Aug 12, 2015
Slide 1: Canaccord Genuity Growth Conference 2015
Click to edit Master title style Canaccord Genuity Growth Conference 2015 August 12, 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 Investment Thesis
Click to edit Master title style Lipocine Investment Thesis ▪ First oral testosterone replacement (TRT) option • Targeting ~ $2.0 Billion TRT market • On schedule for 2015 NDA submission • Clearly differentiated ▪ First orphan designated oral alternative for the prevention of preterm birth • A voids
Slide 4: Focused on Innovative Products for Men's and Women's Health
Click to edit Master title style 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 HEALT
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 all data sets ▪ Completed the 52 week safety extension arm • Well tolerated • No cardiac, hepatic or drug related SAEs • Overall AE profile comparable
Slide 6: TRT: Significant 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 ▪ Oral T expected to expand market ▪ International TRT markets growing 6 TRT: Significant Market Opportun
Slide 7: TRT Monthly TRx Trend
Click to edit Master title style TRT Monthly TRx Trend 7 ▪ To date, minimal TRx impact of FDA TRT label change ▪ 2015 – monthly TRx stable around 500,000 1 /month 1 IMS Data FDA Label Guidance
Slide 8: A Safer Route of Administration
Click to edit Master title style 8 LPCN 1021 (First Oral TRT Option): “A Safer Route of Administration” Issues with Non Orals Transfer potential to children, partner and pets 1 No freedom to use around pregnant loved ones 1 Skin irritation potential 1 Pulmonary embolism potential 1 Scarrin
Slide 9: Adherence after Months on Existing Non-Oral TRT Therapies
Click to edit Master title style 9 Adherence after 12 Months on Existing Non - Oral TRT Therapies 1 FDA Advisory Committee Meeting September 17, 2014
Slide 10: Life Uninterrupted with Oral T
Click to edit Master title style 10 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 11: Improved Compliance
Click to edit Master title style 11 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 12: Meaningful Oral T US Sales Potential
Click to edit Master title style Meaningful Oral T US Sales Potential - A cross a wide range of price and market share assumptions 12 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
Slide 13: TRT: Challenges of Oral T Product
Click to edit Master title style ▪ 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 TRT: Challenges of Oral T Product 13 1 Journal
Slide 14: 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 14 LPCN 10
Slide 15: 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 ▪ Well tolerated in 52 week exposure ▪ No drug or cardiac related SAEs reported upon 52 wee
Slide 16: Unequivocal Efficacy in Phase 3
Click to edit Master title style 16 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 17: Friendly Dosing Regimen
Click to edit Master title style 17 41 44 15 2 35 62 0 10 20 30 40 50 60 70 No dose change 1 dose change 2 dose changes % of Subjects LPCN 1021 Active Control 85% of LPCN 1021 subjects required ≤1 dose adjustment with 41% no requiring titration at all Almost all subjects on active control, the m
Slide 18: T levels not sensitive to meal fat variations
Click to edit Master title style 18 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 19: LPCN 1111 (Next Generation 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 20: 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 21: 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 22: LPCN 1107 (First Oral PTB Candidate): Status
Click to edit Master title style 22 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 23: Several Near Term Value Drivers
Click to edit Master title style 23 Compelling Value Proposition: Several Near Term Value Drivers Event Expected Timing LPCN 1021: NDA Filing 2H15 LPCN 1111: Initiate Phase 2b Study 4Q15 LPCN 1107: Initiate PK Dose Finding Study 4Q15 LPCN 1107: End of Phase 2 Meeting 2Q16 LPCN 1111: End of Phase 2 M
Slide 24: Lipocine is a Compelling Value Proposition
Click to edit Master title style 24 Lipocine is a Compelling Value Proposition Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Closing Stock Price (7/31/15) $12.36/share Market Capitalization (7/31/15) $218.1million Fully Diluted Shares Outstanding (7/31/15) 19,716,586 Cash Balance (6/30/15
Slide 25: Lipocine Investment Thesis
Click to edit Master title style Lipocine Investment Thesis ▪ First oral testosterone replacement (TRT) option • On schedule for 2015 NDA submission • Targeting ~ $2.0 Billion TRT market • Clearly differentiated ▪ First orphan designated oral alternative for the prevention of preterm birth • A voids