Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (November 2016)
22 slides from Lipocine's investor presentation, Nov 8, 2016
Slide 1: November 8, 2016
November 8, 2016 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 rela
Slide 3: Lipocine Investment Highlights
Lipocine Investment Highlights Focused on Innovative Products for Men’s and Women’s Health ▪ Differentiated product targeting ~$2.0 Billion established US TRT market ▪ Targets significant unmet need with first entrant advantage ▪ Robust Phase 3 clinical data with branded market leader as active cont
Slide 4: Late-Stage Pipeline
Late - Stage Pipeline First Oral Products Targeting Significant Opportunities PRODUCT (Indication) RESEARCH / PRECLINICAL PHASE 1 PHASE 2 PHASE 3 NDA MEN'S HEALTH LPCN 1021 (Oral Testosterone Replacement Therapy) LPCN 1111 (Next Generation Oral T) WOMEN'S HEALTH LPCN 1107 (Prevention of Preterm Birt
Slide 5: TRT Market: Monthly TRx Trend Stable Following FDA Label Guidance
2016 2014 2015 350 375 400 425 450 475 500 525 550 575 Sep 14 Oct 14 Nov 14 Dec 14 Jan 15 Feb 15 Mar 15 Apr 15 May 15 Jun 15 Jul 15 Aug 15 Sep 15 Oct 15 Nov 15 Dec 15 Jan 16 Feb 16 Mar 16 Apr 16 May 16 Jun 16 Jul 16 Aug 16 Sep 16 Monthly TRx (000s) FDA Label Guidance TRT Market: Monthly TRx Trend St
Slide 6: TRT Market: Gross Sales and TRxs Remains a Significant Opportunity
TRT Market: Gross Sales and TRx’s Remains a Significant Opportunity ▪ Androgel 1.62% has significant portion of $ sales ▪ TRx’s in 2015 evenly split between topicals and injectables Source: IMS Health Dec 2015 $0.0 $0.5 $1.0 $1.5 $2.0 $2.5 2013 2014 2015 Billions ($) Gross Sales Testosterone - Injec
Slide 7: TRT Market: Current Therapies Have Limitations
TRT Market: Current Therapies Topicals and Injectables Have Limitations Black Box Warning • Secondary exposure to testosterone No freedom to use around pregnant loved ones Skin irritation potential Messy to apply and wait to dress Black Box Warning • Pulmonary oil micro embolism (POME) and anaphylax
Slide 8: Challenges with Oral TRT: LPCN 1021 Designed to Overcome Issues
Challenges with Oral TRT LPCN 1021 Designed to Overcome Issues ▪ Native testosterone has poor oral bioavailability with a very short half life (~30 min) – Impractical frequent daily doses would be required to obtain effective levels – Inconsistent and unpredictable performance ▪ Methyl testosterone
Slide 9: 1021: First Oral Option Profile Demonstrated Clinically
LPCN 1021: First Oral Option Profile Demonstrated Clinically ▪ LPCN 1021 met Primary endpoint: 87% response rate vs. FDA requirement of 75% ▪ Secondary endpoints generally consistent with approved products ▪ T levels not affected by food fat content EFFICACY ▪ 52 week long term exposure dataLPCN 102
Slide 10: 1021: Phase 3 Efficacy Achieved Primary Endpoint
LPCN 1021: Phase 3 Efficacy Achieved Primary Endpoint Measure FDA Targets Efficacy Population* 1,2 Full Analysis Set #1 Number of subjects 151 193 % subjects with C avg w ithin normal range (300 - 1140 ng/ dL ) ≥75% 87.4% 87.0% 95 % CI lower bound ≥ 65% 81.7% 82.0% Parameter Mean (CV) Mean (CV) C av
Slide 11: 1021: Phase 3 Efficacy Secondary Endpoints
LPCN 1021: Phase 3 Efficacy Secondary Endpoints ▪ Proportion of subjects achieving maximum serum total T concentrations (Cmax) in predefined Cmax range Measure FDA Threshold 1 Efficacy Population Number of subjects 151 C max < 1500 ng/ dL ≥ 85 % 82.8% 1800 ≤ C max ≤ 2500 ng/ dL ≤ 5 % 4.6% C max > 25
Slide 12: 1021: Phase 3 Safety
LPCN 1021: Phase 3 Safety Demonstrated Safety Over 52 Weeks AE’s greater than 5% LPCN 1021 Active Control Upper Respiratory Tract Infection 5.2% 5.8% Fatigue 2.4% 6.7% ADRs greater than 2% LPCN 1021 Active Control Headache 0.5% 2.9% Acne 2.4% 0.0% Safety Population: Subjects who received at least on
Slide 13: 1021: Path Forward
LPCN 1021: Path Forward Committed to Bringing to Patients ▪ Complete Response Letter (CRL) received from FDA on June 28, 2016 ▪ Post Action Meeting Completed: – FDA noted that proposed dosing regimen might be an acceptable – Dosing validation (DV) clinical study results needed for resubmission – DV
Slide 14: 1111: Next Generation Oral TRT Potential Once-Daily Dosing
LPCN 1111: Next Generation Oral TRT Potential Once - Daily Dosing ▪ Novel bio - reversible 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 – Sin
Slide 15: 1111: Phase 2b Study Design
LPCN 1111: Phase 2b Study Design Once Daily Dose Finding Study 15 ▪ Open label, two - period, multiple dose PK study ▪ Three dose levels of LPCN 1111 in Period 1 (500mg, 750mg and 1000mg) ▪ Two dose levels of LPCN 1111 in Period 2 (1250mg QD and 500mg BID) ▪ Period 1: Subjects (36 hypogonadal males)
Slide 16: 1111: Phase 2b Results / Highlights
LPCN 1111: Phase 2b Results / Highlights Met Primary Study Objectives ▪ Once daily dose identified for the pivotal Phase 3 study ▪ Target once - daily Phase 3 dose met both primary and secondary end points ▪ Good dose - response relationship was observed ▪ Well tolerated with no drug - related sever
Slide 17: Preterm Birth (PTB): Unmet Need
Preterm Birth (PTB): Unmet Need Billion $ Opportunity ▪ One preterm infant per minute in the U.S. 1 ▪ 11.7% of all US pregnancies 2 result in PTB (< 37 weeks) - a leading cause of neonatal mortality and morbidity 3 ▪ ~10x more first year medical costs are for PTB infants than for full term infants 4
Slide 18: Preterm Birth (PTB): Competition
Preterm Birth (PTB): Competition Only Approved Product is an Invasive Injectable 18 ▪ Makena® IM, hydroxyprogesterone caproate (HPC) injection: – Viscous oily vehicle – 21 gauge needle – Injection takes up to 1 min – ~35% of patients experienced injection site pain during clinical trial – ~17% of pa
Slide 19: 1107: First Oral PTB Candidate Addresses Unmet Need
LPCN 1107: First Oral PTB Candidate Addresses Unmet Need ▪ Potential to be the first oral standard - of care therapy – Elimination of 18 - 22 injections – Steady state achieved in 7 days • Enables sooner HPC levels in patients – No lingering HPC levels post delivery ▪ Orphan drug designation – Major
Slide 20: Key Financial Metrics
Key Financial Metrics Compelling Value Proposition Ticker Symbol LPCN (Nasdaq Capital Market) Closing Stock Price (11/4/16) $3.07/share Market Capitalization (11/4/16) $56.1 million Fully Diluted Shares Outstanding (9/30/16) 20.4 million Cash Balance (9/30/16) $28.8 million Debt None 20
Slide 21: Upcoming Milestones
Upcoming Milestones Near Term Value Drivers Event Expected Timing LPCN 1021: Receive assessment feedback from FDA on dosing validation clinical study protocol through Special Protocol Assessment 4Q16 LPCN 1111: FDA Meeting to define registration plan 4Q16 LPCN 1107: Meet with the FDA for Phase 3 stu
Slide 22: Lipocine Investment Highlights
Lipocine Investment Highlights Focused on Innovative Products for Men’s and Women’s Health ▪ Differentiated product targeting ~$2.0 Billion established US TRT market ▪ Targets significant unmet need with first entrant advantage ▪ Robust Phase 3 clinical data with branded market leader as active cont