Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (May 2019)
40 slides from Lipocine's investor presentation, May 28, 2019
Slide 1: Enabling Oral Drug Delivery to Improve Patient Compliance
Enabling Oral Drug Delivery to Improve Patient Compliance May 28, 2019 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: Clinical Stage Biopharmaceutical Company, Metabolic and Endocrine Focus
Clinical Stage Biopharmaceutical Company Metabolic and Endocrine Focus 3 PRODUCT (Indication) PRE - CLINICAL PHASE 1 PHASE 2 PHASE 3 NDA LPCN 1144 (Oral Testosterone for pre - cirrhotic NASH) Paired Biopsy Phase 2 Study in NASH TLANDO (Oral Testosterone for TRT) PDUFA November 9, 2019 TLANDO XR (LPC
Slide 4: Targeted for Non-Alcoholic Steatohepatitis (NASH)
4 Targeted for Non - Alcoholic Steatohepatitis (“NASH”) A silent killer that affects 30 million Americans 1 1. CNBC; published December 30, 2018
Slide 5: Non-Alcoholic Fatty Liver Disease: No Approved Product for NAFLD/NASH
Non - Alcoholic Fatty Liver Disease (“NAFLD”) No Approved Product for the Treatment of NAFLD/NASH 5 LFTs: Liver function test, especially Alaninine amino transferase (ALT) and Aspartame amino transferase (AST) NASH: Non - alcoholic Steatohepatitis, TG: Triglyceride Fatty liver is a reversible condit
Slide 6: Clinical Relationship Between Testosterone and NAFLD Across the Disease Spectrum
Clinical Relationship Between Testosterone and NAFLD Across the Full Disease Spectrum Hepatic Steatosis NASH Cirrhosis “ Men with low testosterone are at high risk for NAFLD .” 1 Free T ( pg /mL) “ Levels of free T decreased significantly with the increased incidence of lobular inflammation, hepatoc
Slide 7: 1144: A Differentiated Oral NASH Therapy Candidate
LPCN 1144: A Differentiated Oral NASH Therapy Candidate Prodrug of Endogenous Testosterone Liver Fat Reduction and Key Serum Biomarkers Potential Favorable Benefits in Systems Outside the Liver Suitable for Chronic Use • Over 40% relative mean liver fat reduction after 16 - weeks of treatment • 48%
Slide 8: 1144: Additional Health Benefits Observed in Hypogonadal Subjects with Elevated ALT
LPCN 1144: Additional Health Benefits Observed in Hypogonadal Subjects with Elevated ALT* SF - 36, Short Form - 36 (0 - 100); PDQ, Psychosexual Daily Questionnaire (0 - 7); * ALT > 40 U/L at Baseline in 52 week SOAR Trial (N=3 3) Mental Component Summary Mental Health Role Emotional Maintained Erect
Slide 9: 1144: Extensive Clinical Safety Database Demonstrated No Unexpected Risks
LPCN 1144: Extensive Clinical Safety Database Demonstrated No Unexpected Risks 0 5 10 15 % Subjects LPCN 1144 Topical T 9 – 650+ subjects in 14 studies with up to 52 week exposure – No drug related SAEs – No deaths or MACE events Gastrointestinal Disorders ≥ 1% in SOAR Trial (52 Weeks)
Slide 10: 1144: Multidimensional Mechanism of Action Across NASH Pathogenesis
LPCN 1144: Multidimensional Mechanism of Action Across the Full Spectrum of NASH Pathogenesis Homeostasis Modifier 1, 2 • Alter lipid, cholesterol, and glucose metabolism • Reduce visceral abdominal fat • Modify activity of hepatic lipase, and skeletal muscle/ adipose lipoprotein lipase Anti - infla
Slide 11: 1144: Liver Fat Imaging Study Design and Baseline Distribution
LPCN 1144: Liver Fat Imaging Study (“LFS”) Study Design and Baseline Liver Fat Subject Distribution 11 LFS was an open - label, multi - center single - arm 16 - week study (N=36) with LPCN 1144 in hypogonadal males LF = liver fat
Slide 12: 1144: Liver Fat Study Results
LPCN 1144: Liver Fat Study Results Meaningful Relative Liver Fat % Change and Responder Rate 12 - 33% - 42% - 40% -60% -50% -40% -30% -20% -10% 0% BL ≥ 5% BL ≥ 8% BL ≥ 10% % Liver Fat CBL ( ± SEM) Mean Relative Liver Fat % Change 71% 80% 75% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% BL ≥ 5% BL ≥ 8
Slide 13: 1144: Liver Fat Based Subject Distribution at Each Visit
LPCN 1144: Liver Fat Study Results Liver Fat Based Subject Distribution at Each Visit 13 38% 32% 6% 24% Baseline Pre treatment 55% 18% 6% 21% 8 Week Treatment 65% 15% 12% 9% 16 Week Treatment ■ LF < 5% (NAFLD Free) ■ 5% ≤ LF < 8% ■ 8% ≤ LF < 10% ■ LF > 10% NAFLD Free NAFLD Free NAFLD Free Longer The
Slide 14: 1144: Next Step Advancing Forward
LPCN 1144: Next Step Advancing Forward • Initiating paired - biopsy Phase 2 clinical study in NASH subjects – Study Design • Three - arm, double - blind placebo controlled • Biopsy confirmed NASH male hypogonadal subjects with NAS ≥ 4 • Paired biopsy at baseline and EOS (36 - weeks) – First - patien
Slide 15: Targeted for Testosterone Replacement Therapy
15 Targeted for Testosterone Replacement Therapy Annual TRx ~7M
Slide 16: TRT Market is Growing
2018 2017 2016 2014 2015 350 375 400 425 450 475 500 525 550 575 600 625 650 675 Oct 14 Dec 14 Feb 15 Apr 15 Jun 15 Aug 15 Oct 15 Dec 15 Feb 16 Apr 16 Jun 16 Aug 16 Oct 16 Dec 16 Feb 17 Apr 17 Jun 17 Aug 17 Oct 17 Dec 17 Feb 18 Apr 18 Jun 18 Aug 18 Oct 18 Monthly TRx (000s) FDA Label Guidance Monthl
Slide 17: Cumulative TRT Sales Last Six Years
Cumulative TRT Sales Last Six Years* Branded Topicals Dominated TRT Sales 17 ANDRODERM ® 5% (~$438M) ANDROGEL ® 74% (~$7B) FORTESTA ® 3% (~$267M) TESTIM ® 7% (~$667M) AXIRON ® 11% (~$1B) Topical Brands Total six years sales : $ 9.4 B Avg. annual sales: $ 1.6 B Topical Brands 82% Other Brands … Gener
Slide 18: 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 19: Current TRT Dosing Regimes
Current TRT Dosing Regimes Over 50% of Patients Require Dose Adjustment with Current TRT Therapies * Current TRT n=412 Q16. Since you started using your current testosterone medication, how many times was the dose adjusted up or down until you reached your current dose level? 0 X 47% 1 X 33% 2 X 15%
Slide 20: TLANDO Attributes: Patient and Physician Preferred Oral Option
TLANDO Attributes Patient and Physician Preferred Oral Option Key Advantages of Oral Route: • No risk of accidental T transference • Non - invasive; easy to use • Less cumbersome/burdensome • Potential for higher persistence/adherence PCP preferred fixed dosing regimen • 450mg (225 mg BID) Daily TU
Slide 21: TLANDO = Opportunity, Near Term FDA Decision
TLANDO = Opportunity Near Term FDA Decision TLANDO™ PDUFA date is November 9, 2019 Significant unmet patient and physician needs with current therapies TLANDO™ is clinically differentiated TRT prescriptions are growing; Share of voice all time low $2B+ Market Opportunity 21
Slide 22: TLANDO XR: First Long Acting Oral
LIPOCIN= TLANDO XR First Long Acting Oral
Slide 23: TLANDO XR (LPCN 1111): Profile
TLANDO XR (LPCN 1111): Profile Once Daily Differentiated Oral TRT • Once daily oral testosterone – New molecule with associated IP – Novel prodrug of testosterone for oral delivery through proprietary drug delivery technology • TLANDO XR proof of concept established – Positive Phase 2b study results
Slide 24: For Treatment of NASH Cirrhosis
24 For Treatment of NASH Cirrhosis
Slide 25: 1148: Oral T for NASH Cirrhosis
LPCN 1148: Oral T for NASH Cirrhosis No FDA Approved Product - Transplant Only Cure Cirrhotic Liver US Prevalence Cirrhotic Patients Characteristics: • Increased morbidity and mortality • Symptoms of hypogonadism: altered hair distribution, anemia, sexual dysfunction, testicular atrophy, muscle wast
Slide 26: Low Testosterone Increases Adverse Outcome in Male Cirrhotic Patients
Low Testosterone Increases Adverse Outcome in Male Cirrhotic Patients T Levels Fall Progressively with Increasing Disease Severity 1 • Low T reported in up to 90% of NASH cirrhosis patients 2 and is a predictor of mortality 3 • Low T associated with: – Increased risk of major infections, death and/
Slide 27: 1148: NASH Cirrhosis Oral T Therapy
LPCN 1148: NASH Cirrhosis Oral T Therapy Potentially help patients survive longer while waiting for a liver transplant • T levels positively correlate with muscle mass in men and modulates bone density, hemoglobin production, insulin resistance, and immunity , commonly impaired in cirrhosis 1 • Test
Slide 28: Upcoming Milestones
Upcoming Milestones 28 Near Term Value Drivers Event Expected Timing TLANDO™ PDUFA Date November 9, 2019 LPCN 1144 Paired Biopsy Phase 2 First Patient Dosed in NASH Patients 3Q 2019
Slide 29: Key Financial Metrics
Key Financial Metrics 29 Stock Price, Market Cap, Cash Balance Ticker Symbol LPCN (Nasdaq Capital Market) Closing Stock Price (5/24/19) $1.57/share Market Capitalization (5/24/19) $38.6 million Cash Balance (3/31/19) $22.5 million* Bank Debt (3/31/19) $9.2 million * $5M restricted and becomes unrest
Slide 30: Appendix
LIPOCIN= Appendix
Slide 31: LPCN 1107
LIPOCIN= LPCN 1107
Slide 32: 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 33: 1107: Prevention of Preterm Birth, US Market Landscape
LPCN 1107: Prevention of Preterm Birth (PTB) United States Market Landscape $1B Market Opportunity 3 December 31, 2017 HPC TRx 3 Makena ® 1 50% Off Guidance 2 30% Compounded 17 - HPC 20% 117% 1. AMAG estimates Makena market share based on distributor dispensing data and all other market share based
Slide 34: 1107: First Oral PTB Candidate, Approved Product Options
LPCN 1107: First Oral PTB Candidate 34 Characteristics of the Only Approved Product Options for PTB IM HPC, Makena ® : ▪ 20 - 25% patients below reported better efficacy HPC level threshold ▪ Total of 18 - 22 injections – Injection location: Upper - outer quadrant of the gluteus maximus – Weekly vis
Slide 35: 1107: Oral HPC Addresses Unmet Need
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 ▪ Next steps: – Explore partnering opportunities LPCN 1107: First Oral PTB Cand
Slide 36: 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‡‡ 36 ‡: Assuming 100% of 140,000 eligible US population treated ‡‡: Assuming ~$51,600 medical costs/PTB
Slide 37: 1107: First Oral HPC for Prevention of Recurrent PTB
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 38: 1107: HPC PK-PD Correlation
LPCN 1107: HPC PK - PD Correlation 38 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 46.3% 27.0% 29.6% 31.3%
Slide 39: 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 39 PK Study: Oral LPCN 1107 vs IM HPC, Makena Treatment D 250mg Weekly Treatment C 800mg BI
Slide 40: 1107: Dose-Finding PK Study Results
LPCN 1107: Dose - Finding PK Study Results 1 40 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