Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (September 2019)
35 slides from Lipocine's investor presentation, Sep 23, 2019
Slide 1: Enabling Oral Drug Delivery to Improve Patient Compliance
Enabling Oral Drug Delivery to Improve Patient Compliance September 23, 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: Lipocine Investment Highlights
Lipocine Investment Highlights 3 Near Term TLANDO PDUFA with a Promising Pipeline “Best In Class” TLANDO Franchise Potential to be a TRT market leader in need of an oral option • TLANDO™ : ~$2B+ opportunity in an established and growing market • Significant unmet need for an oral TRT • Differentiate
Slide 4: Clinical Stage Biopharmaceutical Company
Clinical Stage Biopharmaceutical Company Innovative Product Candidates for Metabolic and Endocrine Disorders 4 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 (Long Acting Oral T
Slide 5: ~$2B+ opportunity in an established and growing market
5 ~$2B+ opportunity in an established and growing market
Slide 6: TRT Market is Growing Without an Oral Option
TRT Market is Growing Without an Oral Option 6 Source: Antares Pharma presentation at JEFFERIES 2019 HEALTHCARE CONFERENCE TRx = Total prescriptions Current Promotional Spend at an All - Time Low
Slide 7: 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 – Discontinuation rates as high as 50% among new p
Slide 8: TLANDO Attributes
TLANDO ™ Attributes Patient and Physician Preferred Option Convenient Oral Route: • No risk of accidental T transference • Non - invasive; easy to use • Less cumbersome/burdensome • Potential for higher persistence/adherence Fixed Dosing Regimen • Easy to use for patients and physicians to prescribe
Slide 9: TLANDO Has The Potential to Drive Market Expansion
TLANDO ™ Has The Potential to Drive Market Expansion Hypogonadism Affects Up to 20 MM American Men 1,2 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 Ce
Slide 10: TLANDO Has Potential to Expand the Market Through Improved Persistence
Source: Adheris Health 2017 TLANDO Has Potential to Expand the Market Through Improved Persistence Some TRT Options Have ~50% Early Discontinuation and ~50% May Require Multiple Dose Adjustments Cohort Period: February 2016 – January 2017 Analysis Period: 12 Months Look Back: 6 months for new patien
Slide 11: Current Market Dynamics in TRT Space
Current Market Dynamics in TRT Space Prime Opportunity for TLANDO™ • 85% of physicians have strong interest in oral • 95% of TRT patients likely to ask their doctor about TLANDO ™ Patient and physicians preferred 1 • Able to have high share of voice with far less competitive promotion than in the pa
Slide 12: TLANDO - Opportunity in a Market Ready for Change
TLANDO ™ - Opportunity in a Market Ready for Change PDUFA goal date: November 9, 2019 Favorable market dynamics ~$2B+ opportunity in an established and growing market Significant unmet need for an oral TRT Differentiated profile appropriate for market expansion 12 Potential for market leadership
Slide 13: Non-Alcoholic Fatty Liver Disease (NAFLD)
Non - Alcoholic Fatty Liver Disease (“NAFLD”) No Approved Product for the Treatment of NAFLD/NASH 13 LFTs: Liver function test, especially Alaninine amino transferase (ALT) and Aspartame amino transferase (AST) NASH: Non - alcoholic Steatohepatitis, TG: Triglyceride 1. Sarkar et al. Gastroenterology
Slide 14: Targeted for Non-Alcoholic Steatohepatitis (NASH)
14 Targeted for Non - Alcoholic Steatohepatitis (“NASH”)
Slide 15: LPCN 1144: Differentiated NASH Treatment Candidate
LPCN 1144: Differentiated NASH Treatment Candidate Potential for Mono/Combo Chronic Therapy Meaningful POC Efficacy Results Well Tolerated 700+ subjects in 14 studies with up to 52 - week exposure Potential Additional Benefits Most biopsy confirmed male NASH have low testosterone • Over 40% relative
Slide 16: LPCN 1144: Liver Fat Imaging Study
LPCN 1144: Liver Fat Imaging Study (“LFS”) Over Sixty Percent of Hypogonadal Subjects had Fatty Liver (LF>5%) 16 LFS was an open - label, multi - center single - arm 16 - week study (N=36) with LPCN 1144 in hypogonadal males LF = liver fat 66% 25% 0% 10% 20% 30% 40% 50% 60% 70% LFS Population† Gener
Slide 17: LPCN 1144: Liver Fat Study Results
LPCN 1144: Liver Fat Study Results Meaningful Relative Liver Fat % Change and Responder Rate 17 - 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 18: LPCN 1144: Longitudinal Treatment Effect
LPCN 1144: Longitudinal Treatment Effect ■ NAFLD Free (LF < 5%) ■ NALFD (LF ≥ 5%) NAFLD Free NAFLD Free NAFLD Free Liver Fat Based Subject Distribution at Each Visit NAFLD Free NAFLD Free NAFLD Free 38% 63% Baseline (N=32)* NAFLD Free NAFLD 52% 48% Interim (Week 8, N=31) NAFLD Free NAFLD 63% 38% End
Slide 19: LPCN 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 – Initiated – Study Design • Three - arm, double - blind placebo controlled • ~75 biopsy confirmed NASH male subjects with NAS ≥ 4 • Paired bi
Slide 20: Upcoming Milestones
Upcoming Milestones 20 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 Primary Endpoint Results (Liver Fat Reduction via MRI - PDFF) 3Q 2019 Mid - 2020 LPCN 1148 File Investig
Slide 21: Key Financial Metrics
Key Financial Metrics 21 Stock Price, Market Cap, Cash Balance Ticker Symbol LPCN (Nasdaq Capital Market) Closing Stock Price (9/19/19) $2.90/share Market Capitalization (9/19/19) $75.5 million Cash Balance (6/30/19) $19.5 million* Bank Debt (6/30/19) $8.7 million * $5M restricted and becomes unrest
Slide 22: Appendix
LIPOCIN= Appendix
Slide 23: TLANDO
LIPOCIN= TLANDO™
Slide 24: 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 25: LPCN 1144
LIPOCIN= LPCN 1144
Slide 26: Estimated LPCN 1144 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 26 1. Sarkar et al. Gastroenterology 156(6):S - 1258 & Poster Sa1623 Digestive Disease Week 2019 2. Estes et al
Slide 27: LPCN 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 28: 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 29: 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 30: LPCN 1144: Additional Health Benefits Observed
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 31: LPCN 1144: Extensive Clinical Safety Database
LPCN 1144: Extensive Clinical Safety Database Demonstrated No Unexpected Risks 0 5 10 15 % Subjects LPCN 1144 Topical T 31 – 700+ 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 32: For Treatment of NASH Cirrhosis
32 For Treatment of NASH Cirrhosis
Slide 33: LPCN 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 34: 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 35: LPCN 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