Adma Biologics Inc · NASDAQ:ADMA
Adma Biologics — Investor Presentation (December 2013)
36 slides from Adma Biologics's investor presentation, Dec 9, 2013
Slide 1: Corporate Overview
AWATE-STAGE BIOPHARNMIACEUTICAL COMP. FOCUSED ON SPECIALTY PLASMA BASED BIOL CORPORATE OVERVIEW December 2013
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS This document contains forward-looking statem ents about ADMA Biologics, Inc (the “Company”), These statements include statements about our development plans, timing of regulatory action, results of clinical trials, achievernent of milestones, market size and opportunity,
Slide 3: Corporate Highlights
CORPORATE HIGHLIGHTS 7 FOCUSED ON SPECIALIZED, HIGH-TITER, HUMAN IMMUNE GLOBULINS (IVIG) 7 ONGOING PIVOTAL PHASE III TRIAL FOR RI-002 * Novel IVIG product, enriched with high-levels of anti-RSV antibodies * Well-established FDA regulatory path to approval * Patient enrollment completed * Potential f
Slide 4: Experienced Management Team and Board of Directors
EXPERIENCED MANAGEMENT TEAM AND BOARD OF DIRECTORS NAME ADAM GROSSMAN Founder, President, CEO & Director BRIAN LENZ, CPA Chief Financial Officer SELECTED CURRENT OR PAST AFFILIATIONS. Rares JAMES MOND, M.D., PH.D. %, Chief Scientific Officer & Qi Wiz Chief Medical Officer oat Inco STEVEN ELMS AISLIN
Slide 5: Blood Contains: Plasma, Red Cells, White Cells, Platelets
7 BLOOD CONTAINS: PLASMA, RED CELLS, WHITE CELLS, PLATELETS 7 PLASMA CONTAINS: PROTEIN, WATER 7 PLASMA’S PROTEINS CONTAIN MANY THERAPEUTIC BENEFITS *IVIG is made from a key therapeutic protein in plasma COMPOSITION OF BLOO Platelets, Red & White Blood Cells, Z Factor Vill, 136 45; Other, 3%. Other,
Slide 6: Sizeable Market — IVIG
SIZEABLE MARKET — IVIG 7~S15 BILLION WORLDWIDE MARKET FOR PLASMA PRODUCTS 7~§3.5 BILLION US IMMUNE GLOBULIN MARKET US IG Sales in Billions 7 USED TO TREAT « - ¥ $4.0 7 * Primary immune deficiencies % " CAGR ~ 13.5% * Autoimmune diseases | * Immune-compromised patients $3.0. * Neuropathy 47 GROWTH DR
Slide 7: Sizeable Market — RSV Incidence
SIZEABLE MARKET — RSV INCIDENCE RESPIRATORY SYNCYTIAL VIRUS (RSV) OVERVIEW 7 RSV INFECTION IS A SERIOUS PROBLEM FOR IMMUNE-COMPROMISED PATIENTS J APPROXIMATELY 5-15% RSV INFECTION RATE IN IMMUNE-COMPROMISED PATIENT POPULATIONS 7 RSV-INFECTED HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) PATIENTS HAVE PO
Slide 8: RSV Season in the US for 2011-2012
RSV SEASON IN THE US FOR 2011-2012 / a0 weeks a Average Length of RSV Season a an ee 2011-2012 oe == 2123 weeks 128.49 weeks 145 weels
Slide 9: Sizeable Market — ADMA Products RI-002 Targeted to Immune-Compromised Patients
SIZEABLE MARKET — ADMA PRODUCTS 7 RI-002 IS TARGETED TO IMMUNE-COMPROMISED PATIENTS 7 INITIAL INDICATION PATIENT TARGET: PRIMARY IMMUNE DEFICIENCY DISEASE (PIDD) 7 250,000 PIDD PATIENTS IN THE US, 50% ARE TREATED WITH IVIG (~125,000) Class Est. Incidence (US Population) Comments Target Population Nu
Slide 10: Sizeable Market — ADMA Products (Cont'd)
SIZEABLE MARKET — ADMA PRODUCTS (CONT’D) - POTENTIAL FOLLOW-ON INDICATION POPULATIONS: 47 HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) — * ~25,000 procedures/year performed in the US 7 SOLID ORGAN TRANSPLANT (LUNG, HEART, LIVER AND MULTI-ORGAN) — + ~11,000 solid organ transplants/year (excluding kidney
Slide 11: Lead Product Candidate (RI-002)
LEAD PRODUCT CANDIDATE (RI-002) 7 RI-002 » Polyclonal IVIG product enriched with standardized, enhanced levels of anti-RSV antibodies 4 TARGETED TO IMMUNE-COMPROMISED PATIENTS * Initial indication: Primary Immune Deficiency Disease (PIDD) * Potential follow-on indications: — Hematopoietic stem cell
Slide 12: Ongoing Pivotal Phase III Trial
ONGOING PIVOTAL PHASE III TRIAL 7 FDA'S “GUIDANCE FOR INDUSTRY: SAFETY, EFFICACY AND PHARMACOKINETIC STUDIES TO SUPPORT MARKETING OF IMMUNE GLOBULIN INTRAVENOUS (HUMAN) AS A REPLACEMENT THERAPY FOR PRIMARY HUMORAL IMMUNODEFICIENCY” (CBER, JUNE 2008) PATIENT POPULATION PRIMARY IMMUNE DEFICIENCY DISEA
Slide 13: Timeline for RI-002 Milestones
TIMELINE FOR RI-002 MILESTONES 2013 2014 2015 2016 Qi |/o2 | a3'o4 ar | G2 | Gs \a4 | at || a2) 03) an) at | 2 | a3 | a4 First Patient Enrolled in Phase III Compkted Initial Public Offering compieted || Last Patient Enrolled in Phase III Compkted Ongoing Phase Dosing rT | Preliminary Phase Ill Data
Slide 14: Historical Data Overview
HISTORICAL DATA OVERVIEW December 2013
Slide 15: 2013 RSV Vaccines for the World Conference - Abstract & Oral Presentation
2013 RSV VACCINES FOR THE WORLD CONFERENCE - 7 ABSTRACT & ORAL PRESENTATION: * “Polyclonal Human IVIG with Standardized High Levels of RSV Neutralizing Antibodies: A Summary of Human and Animal Studies” 7 DATA FROM 3 STUDIES * Cotton Rat Model * Phase II Dose Finding Study in Transplant Patients * C
Slide 16: Cotton Rat Protection - Animal Model
COTTON RAT PROTECTION - ANIMAL MODEL 7 25 MALE COTTON RATS, 6- 8 WEEKS (GROUPS OF 5) 7 DAY OTEST PRODUCTS INFUSED INTRAPERITONEALLY — ADMA 500mg/kg — ADMA 750mg/kg ~ ADMA 1000mg/kg ~ Reference RSV IVIG 750mg/kg 7 DAY 1: CHALLENGED WITH RSV LONG 3.0 X 107 PFU ML 7 DAY 5 ANIMALS SACRIFICED ~ Nose and
Slide 17: Cotton Rat Protection - Animal Model
COTTON RAT PROTECTION - ANIMAL MODEL oh NASAL & LUNG RSV VIRAL LOAD WAS REDUCED BY 99% IN THE ADMA IVIG TREATED ANIMALS Cotton Rat Lung RSV Viral Load Titers Cotton Rat Nasal RSV Viral Load Titers 5.5 5.5 50 50 3 3 Zas gas Hy rd S40 40 @ 2 335 2 35 g 3 53.0 = 3.0 Bas 3 as g 3 ‘ Eee * | | 1s 1s Salin
Slide 18: Cotton Rat Protection - Animal Model
COTTON RAT PROTECTION - ANIMAL MODEL GMT RSV NEUTRALIZING ANTIBODY TITERS ‘8000 ° os 1 15 2 25 3 35 4 as —*ADMA500 BAMA 750 = ADMA 1000 REF 750 Day of Study 18
Slide 19: RSV Infected Immunocompromised Patients
RSV INFECTED IMMUNOCOMPROMISED PATIENTS PHASE II TRIAL — A MULTICENTER DOSE RANGING STUDY IN I 7 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED (N=21) 7 BMT/HSCT OR SOLID ORGAN TRANSPLANT WITHIN 2 YEARS ON CONCURRENT IMMUNOSUPPRESSIVE TREATMENT 7 RSV BY RT-PCR URI AT TIME OF ENROLLMENT 7 AGES 2-65 ( M
Slide 20: Phase II Trial Results - Primary Outcome - Primary Endpoint
PHASE II TRIAL RESULTS - PRIMARY OUTCOME - 7 PRIMARY ENDPOINT * Define the dose which produced a > 4-fold rise in neutralizing RSV titer at day 18 compared to baseline 7 RESULTS (N=21) + Primary endpoint met + Well-tolerated, no drug-related SAEs were reported Dose # > 4-fold Rise Mean Fold 95% Cl P
Slide 21: Clinically Promising Compassionate Use Experience
CLINICALLY PROMISING COMPASSIONATE USE h EXPERIENCE 7 15 UNSOLICITED COMPASSIONATE USE REQUESTS 7 AGE-3 MONTHS TO 71 YEARS 7 ALL PATIENTS WERE IMMUNOSUPPRESSED AND DIAGNOSED WITH LRT RSV INFECTIONS FOR DAYS OR WEEKS (1 DAY TO 4 WEEKS) 7 UNRESPONSIVE TO CONVENTIONAL THERAPIES * Aerosolized ribavirin
Slide 22: Clinically Promising Compassionate Use Experience Results
CLINICALLY PROMISING COMPASSIONATE USE EXPERIENCE 7 RESULTS * The majority of patients had favorable outcomes — 73% survived LRT RSV infection (11/15) — 4deaths * Pre and post infusion serum samples obtained from 12 patients * All patient samples tested had > 4 fold rise in RSV antibody titers from
Slide 23: Abstract & Presentation Conclusions
ABSTRACT & PRESENTATION CONCLUSIONS 2013 RSV VACCINES FOR THE WORLD CONFERENCE - j 7 THE COTTON RAT MODEL DEMONSTRATES: * Infusion of ADMA IVIG eliminates 99% of viral load in nasal and lung tissue * Highly significant increases in serum RSV neutralizing titers 7 PHASE II TRIAL DEMONSTRATES: * 86% o
Slide 24: Operational Overview: Growth Strategy & Commercialization
OPERATIONAL GVERVIEW: GROWTH) STRATEGY SoCOMMERGIALIZATI December 2013
Slide 25: Growth Strategy: Follow-On Specialty IG Products
GROWTH STRATEGY 7 FOLLOW-ON SPECIALTY IG PRODUCTS CAN PROVIDE ADDITIONAL GROWTH * In-licensed — VZIG (Varicella Zoster Immune Globulin, Biotest AG) for United States and Canada * Contract negotiations ongoing 7 INFECTIOUS DISEASE SPECIFIC IG PRODUCT CANDIDATES * Targeted at Primary Immune deficient
Slide 26: Ongoing Manufacturing and Plasma Supply
ONGOING MANUFACTURING AND PLASMA SUPPLY - 7 SECURED LONG-TERM MANUFACTURING AGREEMENT * Biotest Pharmaceuticals Corporation * 10-year agreement - 2 five-year extensions * FDA approved manufacturing facility 7 SECURED LONG-TERM PLASMA SUPPLY AGREEMENT * Biotest Pharmaceuticals Corporation * 10-year a
Slide 27: US Commercialization Strategy
US COMMERCIALIZATION STRATEGY OVERALL PLAN: Hire small, specialty sales force targeting physicians who identify RSV infections in immune-compromised patients (Infectious Disease & Immunologists) ADDRESSABLE PROGRAMS: ~500 leading specialty programs for treating PIDD patients in the US KEY TARGETS: M
Slide 28: Ex-US Commercialization Strategy
EX-US COMMERCIALIZATION STRATEGY - 7 EUROPEAN, SELECTED MIDDLE EAST AND NORTH AFRICAN COMMERCIAL AGREEMENT WITH BIOTEST AG FOR RI-002 ° Upfront services free of charge, cash payments upon achieving milestones * Royalty stream from foreign sales * ADMA has ability to co-promote in the territory to as
Slide 29: Significant Entry Barriers to Protect Competitive Market Position
SIGNIFICANT ENTRY BARRIERS TO PROTECT I COMPETITIVE MARKET POSITION 7 UNIQUE AND EXCLUSIVE PLASMA DONOR SELECTION CRITERIA 7 EXCLUSIVE METHODOLOGY AND KNOW-HOW FOR FORMULATION OF DONOR PLASMA POOL 7 VALIDATED MICRONEUTRALIZATION ASSAY FOR ANTI-RSV ANTIBODY 7 CELL-BASED, VIRAL MICRONEUTRALIZATION ASS
Slide 30: ADMA BioCenters
ADMABIGCENTERS: PEAS MA PROCURS VENT OYVERY ayy December 2013
Slide 31: US Demand for Source Plasma Is Growing
600 500 400 30 8 20 8 US DEMAND FOR SOURCE PLASMA IS GROWING 7 HUNDREDS OF DISEASES ARE TREATED WITH PRODUCTS MADE FROM HUMAN PLASMA * Over 19 million liters of source plasma collected in the US * Typical plasma collection center can collect 30,000 to 50,000 liters of source plasma annually + Many c
Slide 32: ADMA BioCenters Fulfill Several Important Strategic Goals
ADMA BIOCENTERS FULFILL SEVERA IMPORTANT STRATEGIC GOALS 7 FIRST ADMA BIOCENTER OPENED IN METRO ATLANTA * Received FDA BLA approval in August 2011 * June 2012 entered into third party multi-year supply agreement * Received GHA certification in June 2013 7 OWNERSHIP OF SOURCE PLASMA IS A STRATEGIC AS
Slide 33: Financial Highlights & Anticipated Milestones
FNANGADRIGHUGHTS & ANTICIPATED IVIILESTONES December 2013
Slide 34: Anticipated Milestones & News Flow
ANTICIPATED MILESTONES & NEWS FLOW COMPLETED: * Signed manufacturing and plasma supply partnership for RI-002 Signed licensing partnership for Europe and other foreign territories Obtained GHA and/or other foreign approval for ADMA BioCenters IPO completed October 2013 ("ADMA") Completed enrollment
Slide 35: Ownership and Financial Summary
Options & Fully Diluted Fully Diluted Common Stock Warrants Shares Ownershi Aisling Capital 3,608,171 33,674 3,641,845 35.7% Burrill Capital 1,433,304 16,837 1,450,141 14.2% Grossman Family 1,156,081 493,292 1,549,323 15.2% Other Halders 3,094,317 474,332 3,568,649 34.9% Tatal 9,291,823 918,135 10,2
Slide 36: Corporate Highlights
CORPORATE HIGHLIGHTS 7 1PO COMPLETED OCTOBER 2013 (“ADMA”) Gross proceeds $29.1M * 3,420,821 shares of common stock FOCUSED ON SPECIALIZED, HIGH-TITER, HUMAN IMMUNE GLOBULINS (IVIG) 7 7 ONGOING PIVOTAL PHASE III TRIAL FOR RI-O02 * Novel IVIG product, enriched with high-levels of anti-RSV antibodies
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