Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (May 2014)
32 slides from Lipocine's investor presentation, May 27, 2014
Slide 1: Corporate Presentation May 2014
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 Corporate Presentation May 2014 Exhibit 99.2
Slide 2: Forward-looking statements
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 2 This presentation contains and our discussions during this conference may include forward - looking statements about Lipocine Inc. (the “Company”). These forward - looking sta
Slide 3: Lipocine Investment Highlights
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 3 Focused on developing innovative orally - available treatment alternatives in the areas of men’s and women’s health Lead asset currently in Phase 3 (enrollment complete),
Slide 4: Product Pipeline
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 4 LPCN 1021 - Oral Testosterone Replacement Therapy (TRT) Product Pipeline Men’s Health LPCN 1111 - Next Generation Oral TRT Women’s Health LPCN 1107 - Prevention of Preterm Bir
Slide 5: Lip'ral Enables Optimal Dispersion in the Gastrointestinal Tract
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 5 Lip’ral Enables Optimal Dispersion in the Gastrointestinal Tract Lumen Aqueous Barrier Layer Membrane Systemic Circulation Improved absorption Effective transfer across aqueou
Slide 6: Testosterone Deficiency is Prevalent in U.S.
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 6 Testosterone Deficiency is Prevalent in U.S. 1 (1) Rev. Urol Vol 5. Suppl 1 2003 S3 - S10 - Figure 2 • Men in their 50s 1 in 10 • Men in their 60s 1 in 5 • Men in their 70s 1
Slide 7: Testosterone Replacement Therapy Market
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 7 $2.7 B market in 2013 4 Increased low testosterone (T) awareness driven by Abbott, Glaxo and Lilly promotion Topicals dominate the market (~90%), market leader Androgel
Slide 8: TRT Therapy and Alleged CV Risks
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 8 No well designed placebo controlled, randomized, prospective study results available with respect to TRT and CV risk TRT Therapy and Alleged CV Risks Two recent reported obser
Slide 9: LPCN 1021 Addresses Unmet Need
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 9 LPCN 1021 Addresses Unmet Need 9 Topical LPCN 1021 ▪ Inadvertent transference • Especially to children and partners • Black box warning on all gels x No transference issue or
Slide 10: Survey of endocrinologists and urologists on oral testosterone compliance
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 10 Survey of 28 leading endocrinologist and urologist about oral testosterone compliance 1 • In your opinion, will oral testosterone improve patient compliance compared to exi
Slide 11: LPCN 1021: Overview
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 11 Testosterone Undecanoate (TU, a prodrug of testosterone) oral composition designed for convenient BID dosing • TU is same active as in approved products with long term esta
Slide 12: Successful Phase 2 Dose Finding Without Titration
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 12 Successful Phase 2 Dose Finding Without Titration % of subjects meeting criteria PK parameters LPCN 1021 225 mg BID Da y 15 (n=24) Typical FDA targets for approval of TRT Pri
Slide 13: Phase 2 Study Safety Summary
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 13 No significant adverse events DHT/T and E2/T ratios observed with LPCN 1021 are in the normal range HDL changes with LPCN 1021 in the range of other approved TRT produc
Slide 14: LPCN 1021: Correlation between Primary and Secondary End Points
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 14 R² = 0.857 0 300 600 900 1200 1500 1800 2100 2400 2700 3000 3300 3600 0 100 200 300 400 500 600 700 800 900 1000 1100 1200 Secondary End Point [C max (ng/dL )] Primary End Po
Slide 15: LPCN 1021: Phase 3 Design (SOAR)
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 15 Open label, randomized, active - controlled study of LPCN 1021 in men with low testosterone LPCN 1021: Phase 3 Design (Study of Androgen Replacement – SOAR), Fully Enrolled
Slide 16: LPCN 1021 Status
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 16 LPCN 1021 Status Enrollment Complete (04/28) Last patient 13 - week visit (week of 07/28) Top - line Phase 3 efficacy results File NDA Complete Phase 3 with safety data 1Q 20
Slide 17: Competitive Environment for Oral Testosterone
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 17 Competitive Environment for Oral Testosterone 1) www.clarustherapeutics.com , accessed on April 03, 2014 Rextoro™: Clarus Therapeutics Current Status • NDA filed January 3, 2
Slide 18: LPCN 1111: Next Generation Oral Testosterone
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 18 Novel prodrug of testosterone for oral delivery through proprietary Lip’ral technology Designed to provide balance between adequate bioavailability and sustained daily te
Slide 19: Preterm Birth Represents a Significant Unmet Medical Need
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 19 Preterm birth (PTB) is defined as delivery less than 37 weeks of gestation 11.7% of all US pregnancies 1 result in PTB • Annually 180,000 2 pregnancies with prior history
Slide 20: LPCN 1107: Oral Hydroxyprogesterone Caproate for Preterm Birth
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 20 Potential to be the first oral hydroxyprogesterone caproate (HPC) • API is an approved injectable drug for recurrent preterm birth • Elimination of injection site reaction
Slide 21: LPCN 1107: Phase I Study in Healthy Non-Pregnant Females
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 21 Randomized cross - over design(N=10) • Single dose, 400 mg LPCN 1107 • Two doses, 400 mg LPCN 1107 administered 12 hours apart • Single dose of 250 mg IM HPC Significant
Slide 22: Experienced Management Team
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 22 Mahesh Patel, Ph.D.: Chairman, President, CEO & Co - Founder • Director, Specialty products, Pharmacia and Upjohn Morgan Brown, CPA: Executive Vice President & CFO • CFO,
Slide 23: Financial Highlights
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 23 Financial Highlights Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Last Reported Stock Price (5/1/14) $8.00/share Market Capitalization (5/1/14) $102.2 million Ful
Slide 24: Lipocine Investment Highlights
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 24 Focused on developing innovative orally - available treatment alternatives in the areas of men’s and women’s health Lead asset currently in Phase 3 (enrollment complete),
Slide 25: Appendix
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 Appendix
Slide 26: LPCN 1021: Phase 2 Design
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 26 Group Dose (mg) Study Duration Number of Subjects Enrolled / Completed Sampling Time LPCN 1021 Placebo 1 75 15 Days 16/16 4/3 24 Hour PK profile : Day ‘ - 1’, 1, 8 and 15 Pre
Slide 27: LPCN 1021: Phase 2 Study Patient Disposition
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 27 LPCN 1021: Phase 2 Study - Patient Disposition Patient Disposition – 84 subjects enrolled into the study, 81 subjects completed the study – One subject from placebo group d
Slide 28: Testosterone PK Profile Groups 4 & 5
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 28 Testosterone PK Profile Groups 4 & 5 – Days 15 & 29 0 100 200 300 400 500 600 700 800 0 6 12 18 24 Mean Serum T Concentration (ng/dL) Post AM dose Time (hr) Group 5, 225 mg (
Slide 29: LPCN 1021: Phase 2 Testosterone Results
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 29 PK Parameters Typical FDA targets 75mg 150mg 225mg* 300mg N UMBER OF SUBJECTS 16 15 24 9 P RIMARY E ND P OINTS % of Subjects meeting the criteria on Day 15 C ave, 0 - 24h 300
Slide 30: Intra-Subject Variability of LPCN 1021
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 30 Intra - Subject Variability of LPCN 1021 (Group 1 to 5) Consistent with Current Marketed Products PK Parameter Mean Intra – Subject Variability (%) 75mg (n=16) 150mg (n=15) 2
Slide 31: Inter-Subject Variability of LPCN 1021
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 31 Inter - Subject Variability of LPCN 1021 (Group 1 to 5) Consistent with Current Marketed Products PK Parameter Mean Inter – Subject Variability (%) 75mg (n=16) 150mg (n=15) 2
Slide 32: LPCN 1107: Phase I Study Data
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 32 LPCN 1107: Phase I Study Data Single dose pharmacokinetic parameters - Geometric mean [min - max] Dosing Regimen C max ( ng / mL ) [range] AUC 0 - t ( ng.h / mL ) [range] 400