Slide 1: Corporate Presentation
Enabling oral drug delivery to improve patient compliance March 12, 2018 Corporate Presentation Exhibit 99.1
Slide 2: Forward-Looking Statements
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 forward - looking statement s re
Slide 3: Unique Specialty Pharmaceutical Company
Men's Health Franchise Testosterone Replacement Therapy (“TRT”) Women's Health Preterm Birth (“PTB”) Proprietary Drug Delivery Platform Significant Unmet Need In Both Therapeutic Areas 3 Unique Specialty Pharmaceutical Company Advanced Pipeline
Slide 4: Late-Stage Pipeline
Late - Stage Pipeline 4 Oral Product Candidates Targeting Significant Opportunities PRODUCT (Indication) PRECLINICAL PHASE 1 PHASE 2 PHASE 3 NDA MEN’S HEALTH TLANDO™ (Oral Testosterone Replacement Therapy, TRT) NDA PDUFA Date May 8, 2018 LPCN 1111 (Next Gen. Oral TRT) FDA Meeting 1Q 2018* WOMEN’S HE
Slide 5: Lipocine is Positioned for Success
Lipocine is Positioned for Success Because…… 5 Significant Advantages over Existing Approved Products LPCN 1107 • Poised to be First oral to the market • Potentially better PTB results • Orphan drug designation – Major contribution to patient care TRT Franchise TLANDO™ • Patient preferred first oral
Slide 6: TLANDO
LIPOCIN= TLANDO™
Slide 7: TRT Market is Approaching Heights Experienced in 2013
2017 2016 2014 2015 350 375 400 425 450 475 500 525 550 575 600 625 650 Sep 14 Nov 14 Jan 15 Mar 15 May 15 Jul 15 Sep 15 Nov 15 Jan 16 Mar 16 May 16 Jul 16 Sep 16 Nov 16 Jan 17 Mar 17 May 17 Jul 17 Sept 17 Nov 17 Monthly TRx (000s) FDA Label Guidance Monthly TRT TRx Trend 7 TRT Market is Approaching
Slide 8: Issues with Current Non-oral TRT Options
Issues with Current Non - oral TRT Options • Black Box Warning – Secondary exposure to testosterone – Pulmonary oil micro embolism (POME) and anaphylaxis shock • Inconvenient application or painful injection • Poor persistence reflects need for oral – Average days on therapy is 100 days • More than
Slide 9: TLANDO: Advisory Committee Meeting
TLANDO™: Advisory Committee Meeting BRUDAC Results and Path Forward Voting Question: Is the overall benefit/risk profile of TLANDO™ acceptable to support approval as a testosterone replacement therapy? Results: 6 Yes 13 No Path Forward 9 • Voting rationale: – All 13 “No” votes cited lack of Ambulato
Slide 10: Comparative Oral TU Product Profiles
Comparative Oral TU Product Profiles* TLANDO™ vs Jatenzo ™ ▪ Clinically meaningful BP increase in ABPM study ▪ Major Cardiac Adverse Events Reported in multiple studies ▪ All lipid parameters adversely changed compared with active control ▪ Mean dose: 325 mg BID (40% on 396 mg BID) ▪ 12% reported GI
Slide 11: TRT and Blood Pressure Overview
TRT and Blood Pressure Overview ▪ Long - term study underway to determine definitive link between TRT use and cardiovascular (CV) outcome, if any ▪ Blood pressure effects are surrogate marker of potential CV risk ▪ No known blood pressure effects with any approved TRT product ▪ No ABPM study require
Slide 12: TLANDO DV Study Blood Pressure Data
TLANDO™ DV Study Blood Pressure Data Systolic Clinic BP Measurement - Change From Baseline True mean difference of - 0.15 -4 -3 -2 -1 0 1 2 3 4 5 6 Mean SPB Change 16-002 Day 24 (n=94) 16-002 Day 25 (n=94) Overall 16-002 (n=188) Meaningful BP change based on Jatenzo BRUDAC document* x Minimal Change
Slide 13: TLANDO SOAR Study Blood Pressure Data
-4 -3 -2 -1 0 1 2 3 4 5 6 Mean SPB Change (mmHg) 13-001 TLANDO Week 3 (n=193) 13-001 TLANDO Week 7 (n=182) 13-001 TLANDO Week 13 (n=157) 13-001 TLANDO Week 26 (n=144) 13-001 TLANDO Week 39 (n=138) 13-001 TLANDO Week 52 (n=130) 13-001 TLANDO Overall (n=944) TLANDO™ SOAR Study Blood Pressure Data Syst
Slide 14: Oral TU: Dose-Systolic BP Relationship
Oral TU: Dose - Systolic BP Relationship Dose level appears to play a role on blood pressure changes Oral TU Mean Single SBP Mean Triplicate SBP Mean ABPM Daytime SBP Study / Dose D SBP from baseline Study / Dose D SBP from baseline Study / Dose D SBP from baseline TLANDO LPCN 13 - 001 Wk3 / pre - t
Slide 15: Oral TU Blood Pressure Effects Summary
Oral TU Blood Pressure Effects Summary ▪ No significant increase in clinic measured BP with TLANDO™ in multiple visits across multiple studies at the indicated dosing regimen of 225 mg BID ▪ Dosing regimen appears to play a role on any blood pressure effects ▪ Clinic BP and ABPM measurements are sim
Slide 16: LPCN 1111
LIPOCIN= LPCN 1111 Q LPCN 1111 2 TLANDO
Slide 17: LPCN 1111: Next-Generation Oral TRT
LPCN 1111: Next - Generation Oral TRT • Novel prodrug of testosterone for oral delivery • Once - daily potential expected to sustain and improve market share of oral T franchise • Once - daily feasibility established in Phase 2a and 2b clinical trials – Single - daily oral dose provides T levels in
Slide 18: LPCN 1107
LIPOCIN= LPCN 1107
Slide 19: LPCN 1107: Prevention of Preterm Birth, An Unmet Medical Need
LPCN 1107: Prevention of Preterm Birth (PTB) 19 An Unmet Medical Need 1 Pediatric Research (2006) 60, 775 – 776 Preterm Birth 1 - 19 weeks 20 weeks 34 weeks 37 weeks 40 weeks O NE P RETERM B IRTH E VERY M INUTE 1
Slide 20: United States PTB Prevention Market Landscape
LPCN 1107: Prevention of Preterm Birth (PTB) United States PTB Prevention Market Landscape $1B Market Opportunity 2 December 31, 2017 Makena Net Revenue ($M) Makena ® 1 50% Off Guidance 3 30% Compounded 17 - HPC 20% $334 $385 2016 2017 15% 1. Amag estimates Makena market share based on distributor d
Slide 21: LPCN 1107: First Oral PTB Candidate
LPCN 1107: First Oral PTB Candidate 21 Characteristics Of The Only Approved Product for PTB IM HPC, Makena ® : Current preterm birth standard of care ▪ 20 - 25% patients below reported better efficacy HPC level threshold ▪ Total of 18 - 22 injections – Viscous oily weekly injection – Injection takes
Slide 22: LPCN 1107 - Oral HPC
LPCN 1107 - Oral HPC ▪ Potential for superior efficacy with Phase 3 target dose ▪ No patient discomfort upon administration ▪ Steady state achieved in 7 days ▪ Orphan drug designation – Major contribution to patient care LPCN 1107: First Oral PTB Candidate 22 Addresses Unmet Need
Slide 23: LPCN 1107: Advancing to Phase 3 Readiness
LPCN 1107: Advancing to Phase 3 Readiness Phase 3 Special Protocol Assessment – Progress ▪ Concurrence with FDA to date: – Study Design Elements • Single Phase 3 study • Open label, active comparator, two parallel arms (1:1 randomization) • General inclusion and exclusion criteria and treatment dura
Slide 24: Upcoming Milestones Driving Value in 2018
Upcoming Milestones 24 Driving Value in 2018 Event Expected Timing TLANDO™ Initiate ABPM study Initiate Phlebotomy study PDUFA goal date 1H 2018 1H 2018 May 8, 2018 LPCN 1111 FDA meeting to discuss Phase 3 clinical trial 1Q 2018* LPCN 1107 Conduct Food/Fat Effect clinical study 2H 2018 * Meeting occ
Slide 25: Key Financial Metrics
Key Financial Metrics 25 Stock Price, Market Cap, Cash Balance Ticker Symbol LPCN (Nasdaq Capital Market) Closing Stock Price (3/8/18) $1.60/share Market Capitalization (3/8/18) $34.0 million Fully Diluted Shares Outstanding (12/31/17) 24.4 million Cash Balance (12/31/17) $21.5 million Bank Debt (12
Slide 26: Lipocine Investment Highlights
MEN’S HEALTH Testosterone Replacement Therapy (“TRT”) Franchise • TLANDO™ : Potential first oral TRT option - Differentiated product targeting ~$2.0 billion established US TRT market - Poised to meet and exceed unmet need • LPCN 1111 : Next generation potential once - daily oral TRT option - Positiv
Slide 27: Appendix
Appendix 27
Slide 28: TLANDO
LIPOCIN= TLANDO™
Slide 29: TLANDO: Potential First Oral Option Profile
TLANDO™: Potential First Oral Option Profile Demonstrated Clinically with Target Label Regimen ▪ Met primary endpoint - 80% response rate in “worst - case analysis” vs. FDA requirement of 75% ▪ Met key secondary endpoint - No eligible subjects with T levels >2500 ng/ dL ▪ Other secondary endpoints g
Slide 30: TLANDO BRUDAC Briefing Document FDA Blood Pressure Conclusion
TLANDO™ BRUDAC Briefing Document FDA Blood Pressure Conclusion • “The 52 - week blood pressure data are more reassuring, but are limited by the non - duplicative (single morning) cuff pressure readings, open - label trial design and 38% dropout rate in the Tlando arm. Based on these considerations,
Slide 31: Hypertension: SOAR Phase 3 Clinical Trial Results
Hypertension: SOAR Phase 3 Clinical Trial Results AE’s /Discontinuations related to Increased Blood Pressure System Organ Classification / Preferred Term TLANDO™ (N=210) Androgel 1.62% (N=104) n (%) n (%) Investigations: Blood Pressure Increased 1 (0.5) 2 (1.9) Vascular Disorders: Hypertension 6 (2.
Slide 32: SOAR Trial: Effect on Anti-Hypertensive Therapy
SOAR Trial (Study 13 - 001): Effect on Anti - Hypertensive Therapy Patients With and Without a History of Hypertension (HTN) Subjects of Interest TLANDO N=210 n (%) AndroGel N=104 n (%) Baseline diagnosis of HTN or on antihypertensive therapy 100 (47.6) 49 (47.1) On baseline antihypertensive therapy
Slide 33: Oral TU Mean Doses TLANDO vs. JATENZO
TLANDO JATENZO 13 - 001 16 - 002 CLAR - 09 - 007 CLAR 12 - 011 CLAR - 15 - 012 Mean Dose (BID) 213mg 225mg 292mg 241 mg 325mg Dose Distribution Starting dose (BID) 225mg 225mg 316mg 316mg 237mg Down - titrated 32% (150mg) 22.7% (158mg - 237mg) 72% 1.9% (158mg - 198mg) No changed 52% (225mg) 100% (22
Slide 34: Jatenzo Duplicative Clinic Blood Pressure Results Over Time
Jatenzo ™ Duplicative Clinic Blood Pressure Results* Over Time 34 0.2 0.8 2.8 1.8 - 0.5 - 0.7 Dose Level Appears to Have a Role in Blood Pressure Increase Mean Dose: 237mg Mean Dose: 325mg x Minimal Change in BP from Baseline at Visit 2 *From Jatenzo briefing document for Jan 9 th BRUDAC meeting
Slide 35: TLANDO: Ex-Vivo TU to T Conversion Additional Analysis
• Whole blood collected in plain serum tubes • TU dissolved in ethanolic PBS solution is spiked into freshly collected blood • Allowed to clot for 30 minutes at room temperature • Centrifuged for 15 minutes to harvest serum • TU and T concentrations are measured from the serum samples Serum Normal C
Slide 36: TLANDO: Ex-Vivo TU to T Conversion with in-vitro TU addition
0 200 400 600 800 1000 1200 0 1000 2000 3000 4000 5000 Measured Serum T Level (ng/dL) Measured Serum TU Level (ng/dL) Donor 1 Donor 2 Donor 3 Donor 4 TLANDO™: Ex - Vivo TU to T Conversion with in - vitro TU addition TU and T Evaluation in Blood/Serum Process x T levels don’t increase with increasing
Slide 37: Evaluation of Testosterone without TU addition
Evaluation of Testosterone in the without TU addition • Morning (6 – 10 AM) blood samples from 97 healthy males (19 – 40 yrs old) were drawn in plain serum and NaF – EDTA plasma tubes under fasted condition* x T levels from Plasma NaF /EDTA tubes were 14.2% lesser than serum tubes *From Jatenzo brie
Slide 38: Evaluation of Testosterone post Oral TU administration
Evaluation of Testosterone post Oral TU administration • 14 blood samples from 8 hypogonadal subjects were drawn in plain serum and NaF – EDTA plasma tubes following a single oral dose of 316mg TU* x Cavg T levels from Plasma NaF /EDTA tubes were 13% lesser than serum tubes *From Jatenzo briefing do
Slide 39: TLANDO: Serum Testosterone Assay Data Are Reliable
• No conversion of TU to T occurs ex - vivo during blood collection and serum sample processing • Treatment outcomes confirm reliability of T measurements – Pharmacological effects (e.g., LH/FSH suppression) – Testosterone metabolite levels (e.g., E2) TLANDO™: Ex - Vivo TU to T Conversion Serum Test
Slide 40: HPC Concentration and PTB Rates
HPC Concentration and PTB Rates 40 40
Slide 41: PTB Prevalence
PTB Prevalence CONFIDENTIAL Born Too Soon, Global Action Report on Preterm Birth, WHO, 2012 1. India 2. China 3. Nigeria 4. Pakistan 5. Indonesia 6. United States of America 7. Bangladesh 8. Philippines 9. Dem. Rep. of Congo 10. Brazil 10 Countries Account for 60% of the World’s Preterm Births by Ra
Slide 42: PTB Risk Factors
PTB Risk Factors • Prior spontaneous PTB • Having a short cervix • African American ethnicity • Age <18 years or >40 years • Problem with uterus or cervix - mature cervical dilation • Certain infections during pregnancy (UTI, vaginal, uterine) • High blood pressure, stress, diabetes or being underwe
Slide 43: Infant Mortality/Morbidity Related to Gestational Age
Infant Mortality/Morbidity Related to Gestational Age* * Composite index is composed of neonatal death, Grade 3 or 4 intraventricular hemorrhage, respiratory distress syndrome, bronchopulmonary dysplasia, and necrotizing enterocolitis. 0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 23 24 25 26 27 28 29 30 31 3
Slide 44: Benefit of Prolonging Gestation Age
Benefit of Prolonging Gestation Age* * Gilbert et al., Obstet Gynecol. 2003 Neonatal Hospital Days 92.0 75.9 66.8 52.3 39.5 30.4 21.5 14.8 9.0 5.9 3.9 2.8 2.2 0 10 20 30 40 50 60 70 80 90 100 25 26 27 28 29 30 31 32 33 34 35 36 37 Neonatal hospital stay (days) Gestational Age (weeks) 44
Slide 45: High PTB Medical Costs
High PTB Medical Costs • 12% of all US pregnancies 1 (475 - 500K) result in PTB (< 37 weeks) - a leading cause of neonatal mortality and morbidity • First year medical costs for PTB infants are ~ 10x higher than for full term infants 2 • 28% of preterm births are to women with histories of early del
Slide 46: LPCN 1107: Economic Impact
LPCN 1107: Economic Impact Potential Lower PTB Rate – US and Resulting Savings Assuming 4.3% lower PTB rate relative to Makena® ~6000 fewer annual PTBs ‡ Estimated annual cost saving in ~$310M ‡‡ 46 ‡: Assuming 100% of 140,000 eligible US population treated ‡‡: Assuming ~$51,600 medical costs/PTB
Slide 47: LPCN 1107: First Oral PTB Candidate
LPCN 1107: First Oral PTB Candidate First Oral HPC for Prevention of Recurrent PTB • Preferred route - of - administration is oral Strong Exclusivity Position • Orphan Drug Designation • Technology/IP protection Potential for Superior Efficacy • Fewer PTB babies with significant healthcare cost savi
Slide 48: LPCN 1107: HPC PK-PD Correlation
LPCN 1107: HPC PK - PD Correlation 48 HPC Concentration and PTB Rate with IM HPC, Makena 1 N=315 1. Caritis et al., Am J Obstet Gynecol. 2014 (N=315 subjects) 2. C trough C avg for IM Makena® • Lower % PTB rate can be expected with daily C avg 2 HPC levels ≥ 8.2 ng/mL 2 46.3% 27.0% 29.6% 31.3%
Slide 49: LPCN 1107: Dose Finding Study Design
LPCN 1107: Dose Finding Study Design • Open - label, four - period, four - treatment study • 12 healthy pregnant women - Ages 18 - 35 years; 16 - 18 weeks gestation • All subjects received all four treatments 49 PK Study: Oral LPCN 1107 vs IM HPC, Makena Treatment D 250mg Weekly Treatment C 800mg BI
Slide 50: LPCN 1107: Dose-Finding PK Study Results
LPCN 1107: Dose - Finding PK Study Results 1 50 Oral LPCN 1107 vs IM HPC, Makena 1. PK results obtained post 8 days of BID dosing for LPCN 1107 and post 5 weeks for weekly IM HPC, Makena Lower reported PTB rate threshold • HPC levels below 8.2 ng/mL: – Target LPCN 1107 Phase 3 dose was 0% vs 20% sub