Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (July 2019)
47 slides from Lipocine's investor presentation, Jul 23, 2019
Slide 1: Enabling Oral Drug Delivery to Improve Patient Compliance
Enabling Oral Drug Delivery to Improve Patient Compliance July 23, 2019 Corporate Presentation Exhibit 99.2
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 TLANDO (Oral Testosterone for Testosterone Replacement Therapy “ TRT”) PDUFA November 9, 2019 TLANDO XR (LPCN 1111) (Long Acting Oral Testosterone for TRT) Phase 2
Slide 4: TLANDO Franchise Status
TLANDO ™ Franchise Status Differentiated Oral Testosterone Replacement Candidates TLANDO: PDUFA Date: November 9, 2019 TLANDO XR Once - a - Day Phase 2 Complete 4 4 Not subject to any 3 rd party data exclusivity
Slide 5: Fixed Dose Oral Product Targeted for Testosterone Replacement Therapy
5 Fixed Dose Oral Product Targeted for Testosterone Replacement Therapy
Slide 6: Hypogonadism Affects Up to 6MM American Men
Hypogonadism Affects Up to 20 MM American Men 1,2 TLANDO™ Has The Potential To Drive Market Expansion 1.5MM 2.2MM 6MM 700,000 Available switch patients Men currently being treated 4 Men with diagnosed hypogonadism 3 Available naïve patients per year 5 3.8MM diagnosed but untreated patients 1. US Cen
Slide 7: Monthly TRT TRx Trend
Monthly TRT TRx Trend 7 100,000 200,000 300,000 400,000 500,000 600,000 700,000 Total TRx Topical TRx Injectable TRx 6,527,930 6,982,566 7,339,598 7% 5.1% Source: IMS database TRx = Total prescriptions TRT Market is Growing
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: Discontinuation Rates as High as 50% After Only 30 Days with Topical TRT
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 0 30 60 90 120 150 180 210 240 270 300 330 360 % Patients Remaining on Therapy Days to Discontinuation New Patients Experienced Patients Source: Adheris Health 2017 Discontinuation Rates as High as 50% After Only 30 Days with Topical TRT TLANDO has Potenti
Slide 10: 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 11: TLANDO Attributes
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 12: TLANDO = Opportunity in a Market Ready for Change
TLANDO = Opportunity in a Market Ready for Change Near Term FDA Decision ~$2B+ Market Opportunity with growing scripts Significant unmet patient and physician needs Differentiated fixed dose product profile Share of voice all time low; detail sensitive; concentrated call points 12 TLANDO™ PDUFA date
Slide 13: TLANDO XR: First Long Acting Oral TRT
LIPOCIN= TLANDO XR First Long Acting Oral TRT
Slide 14: 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 15: Targeted for Non-Alcoholic Steatohepatitis (NASH)
15 Targeted for Non - Alcoholic Steatohepatitis (“NASH”)
Slide 16: Non-Alcoholic Fatty Liver Disease (NAFLD)
Non - Alcoholic Fatty Liver Disease (“NAFLD”) No Approved Product for the Treatment of NAFLD/NASH 16 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 condi
Slide 17: Male NASH Patients Target Market
~8M Male NASH patients 3 ~17M NASH patients in 2015 2 83M NAFLD patients in 2015 2 Estimated LPCN 1144 Target Market Reportedly 75% of NASH Male Patients Have Total T less than 372 ng/dL 1 17 1. Sarkar et al. Gastroenterology 156(6):S - 1258 & Poster Sa1623 Digestive Disease Week 2019 2. Estes et al
Slide 18: Unmet Need in Pre-Cirrhotic NASH
Unmet Need in Pre - Cirrhotic NASH Currently No Approved Product to Treat Pre - Cirrhotic NASH 1.Sarkar et al. Gastroenterology 156(6):S - 1258 & Poster Sa1623 Digestive Disease Week 2019 2. Dorota et al., Sex Med Rev. 2019, 1 - 2. 3. Yu et al. BMC Gastroenterology (2018) 18:51 https://doi.org/10.11
Slide 19: 1144: Multidimensional Mechanism of Action
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 20: 1144: Liver Fat Imaging Study Design
LPCN 1144: Liver Fat Imaging Study (“LFS”) Study Design and Baseline Liver Fat Subject Distribution 20 LFS was an open - label, multi - center single - arm 16 - week study (N=36) with LPCN 1144 in hypogonadal males LF = liver fat
Slide 21: 1144: Liver Fat Study Results
LPCN 1144: Liver Fat Study Results Meaningful Relative Liver Fat % Change and Responder Rate 21 - 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 22: 1144: Next Step Advancing Forward
LPCN 1144: Next Step Advancing Forward • LiFT (Liver Fat intervention with oral Testosterone) Phase 2 paired - biopsy Phase 2 clinical study in NASH subjects – In progress – Study Design • Three - arm, double - blind placebo controlled • Biopsy confirmed NASH male subjects with NAS ≥ 4 • Paired biop
Slide 23: 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 Suitable for Chronic Use 700+ subjects in 14 studies with up to 52 - week exposure Potential Favorable Benefits in Systems Outside the Liver • Over 40% relative mea
Slide 24: Upcoming Milestones
Upcoming Milestones 24 Near Term Value Drivers Event Expected Timing TLANDO™ PDUFA Date November 9, 2019 LPCN 1144 LiFT Phase 2 Paired Biopsy Clinical Study in NASH Subjects - First Patient Dosed 3Q 2019
Slide 25: Key Financial Metrics
Key Financial Metrics 25 Stock Price, Market Cap, Cash Balance Ticker Symbol LPCN (Nasdaq Capital Market) Closing Stock Price (7/19/19) $1.83/share Market Capitalization (7/19/19) $45.2 million Cash Balance (3/31/19) $22.5 million* Bank Debt (3/31/19) $9.2 million * $5M restricted and becomes unrest
Slide 26: Appendix
LIPOCIN= Appendix
Slide 27: Differentiated Oral Product Targeted for Testosterone Replacement Therapy
27 Differentiated Oral Product Targeted for Testosterone Replacement Therapy Annual TRx ~7M
Slide 28: TLANDO: NDA Under Review
TLANDO™: NDA Under Review Near Term FDA Decision Deficiency 1 Determine extent, if any, of ex - vivo conversion of TU to T Deficiency 2 Characterize blood pressure effects of TLANDO for appropriate regulatory action Deficiency 3 Provide justification for non - applicability of Cmax based secondary e
Slide 29: Targeted for Non-Alcoholic Steatohepatitis (NASH)
29 Targeted for Non - Alcoholic Steatohepatitis (“NASH”) A silent killer that affects 30 million Americans 1 1. CNBC; published December 30, 2018 MB372
Slide 30: Clinical Relationship Between Testosterone and NAFLD
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 31: 1144: Additional Health Benefits 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 32: 1144: Extensive Clinical Safety Database
LPCN 1144: Extensive Clinical Safety Database Demonstrated No Unexpected Risks 0 5 10 15 % Subjects LPCN 1144 Topical T 32 – 650+ subjects in 14 studies with up to 52 weeks exposure – No drug related SAEs – No deaths or MACE events Gastrointestinal Disorders ≥ 1% in SOAR Trial (52 Weeks) Adverse Eve
Slide 33: 1144: Liver Fat Study Results by Visit
LPCN 1144: Liver Fat Study Results Liver Fat Based Subject Distribution at Each Visit 33 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 34: For Treatment of NASH Cirrhosis
34 For Treatment of NASH Cirrhosis
Slide 35: 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 36: 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 37: 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 38: LPCN 1107
LIPOCIN= LPCN 1107
Slide 39: High PTB Medical Costs
High PTB Medical Costs • 10% 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 40: 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 41: 1107: First Oral PTB Candidate
LPCN 1107: First Oral PTB Candidate 41 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 42: 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 ▪ Next steps: – Explore partnering opportunities LPCN 1107: First Oral PTB Cand
Slide 43: 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‡‡ 43 ‡: Assuming 100% of 140,000 eligible US population treated ‡‡: Assuming ~$51,600 medical costs/PTB
Slide 44: 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 45: 1107: HPC PK-PD Correlation
LPCN 1107: HPC PK - PD Correlation 45 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 46: 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 46 PK Study: Oral LPCN 1107 vs IM HPC, Makena Treatment D 250mg Weekly Treatment C 800mg BI
Slide 47: 1107: Dose-Finding PK Study Results
LPCN 1107: Dose - Finding PK Study Results 1 47 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