Adma Biologics Inc · NASDAQ:ADMA
Adma Biologics — Investor Presentation (December 2014)
34 slides from Adma Biologics's investor presentation, Dec 11, 2014
Slide 1: Improving Health for the Immune Compromised with Advanced Therapies Derived from Human Plasma
Improving Health for the Immune Compromi: with Advanced Therapies Derived from Human Plasma
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS wld This document contains forartooiong statements about ADA Blogs. Ine we" rte “Comeany’ ncn. wtoutImtate, statements hat may Prot, orca inet, or np fate su, prtormance o achievement, wich may catan te worde “estimate “projet inten ocak "aiget”“anicpste” “plan” “panning”
Slide 3: Corporate Highlights
CORPORATE HIGHLIGHTS: « Focused on Specialty, High-Titer, Human Immune Globulin (1VIG) «+ Pivotal Phase Ill Tial for RI-002 Met Primary Endpoint + No reported Incidence of Serlous Bacterial Infections (SB!) + Met FDA requirement = 1 S81/Patlent-Year » RI-002 - IVIG Lead Product + Novel VG, enriched
Slide 4: Blood & Plasma Composition
BLOOD & PLASMACOMPOSITION + Blood Contains: Plasma, Red Cells, White Cells, Platelets * Plasma Contains: Protein, Water » Plasma’s Proteins Contain Many Therapeutic Benefits + IVIG Is made from a key therapeutic proteln in plasma + IgG = naturally occurring polyclonal antibodies against bacteria, fu
Slide 5: Sizeable Market - IVIG
SIZEABLE MARKET - IVIG IVIG is Widely Used and Reimbursed for a Variety of On-Label and Evidence-Based Disorders ~$3.5 Billion US Immune Globulin (IG) Market US.IMIG market (2009.19) US. marke + Intvenousimmune globulin (WIG) is a pooled plasma product from healthyblood donors, containinga range of
Slide 6: Sizeable Market - Incidence of Infections and RSV
SIZEABLE MARKET - INCIDENCE OF INFECTIONS AND RSV «+ Lower Respiratory Tract Infection is the Most Common Infectious Cause of Death in the World + Stated by the World Heath Organization ‘Most Bacterial Pneumonias are Preceded by a Viral Upper Respiratory Tract Infection (URTI) + Viral URTI impairs t
Slide 7: Market - PIDD
MARKET - PIDD ‘+ RI-002 Is Targeted to Immune-Compromised Patients «Initial Indication Patient Target: Primary immune Deficiency Disease (PIDD) ‘250,000 PIDD Patients in the US, 50% are Treated with IVIG (~125,000) ‘Common Vatisle inne Deteney (CMD) Severe Combined immune DeteencySynaome (SID) Wiset
Slide 8: Market Overview - PIDD and Infections
MARKET OVERVIEW - PIDD AND INFECTIONS Ina Subjective Survey Conducted on our Behalf, Physicians Polled were Found to have the Following Views Regarding PIDD Patients: i We + Physicians view bacterial infections as Patek — ||ecrontindwaninmost,| Moe concontn the most concerningin PID patients + Immun
Slide 9: Sizeable Market - ADMA Products (Cont'd)
SIZEABLE MARKET - ADMA PRODUCTS (CONT'D) « Type and Severity of Immune Deficiency « Age + Impaired Pulmonary Function + Bronchiectasis + Asthma + History of respiratory infection / Environmental conditions » Hematopoietic Stem Cell Transplant (HSCT) + ~25,000 procedures/year performed in the US « So
Slide 10: How is RI-002 Different Than Other IVIG Products?
HOW1S RI-002 DIFFERENT THAN OTHERIVIG PRODUCTS? » Meets FDA Requirements for IVIG Products + Donor pool size > 1,000 + Minimum titers to certain infectious agents ~ release testing specifications + Polyclonal antibodies meet FDA requirements « Standardized Elevated Levels of RSV Neutralizing Antibod
Slide 11: Lead Product Candidate (RI-002)
LEAD PRODUCT CANDIDATE (RI-002) RIC Polyclonal IVIG Product Enriched with Standardized, High-Levels of Anti-RSV Antibodies « Efficacy Confirmed - Met Phase III Primary Endpoint cn + Targeted to Immune-Compromised Patients X Z + Initial indication: Primary Immune Deficiency Disease (PIDD) + Potential
Slide 12: Positive Top-Line Data for RI-002 in PIDD Phase III
POSITIVE TOP-LINE DATA FOR RI-0021N PIDD PHASEIII CLINICALTRIAL Pivotal Phase Ill Trial Met Primary Endpoint ‘+ RI-002 Prevented Serious Bacterial Infections like Bacterial Pneumonia, Osteomyelitis and Bacterial Sepsis ‘Trial was based on: FDA's “Guidance for Industry: Safety, Efficacy and Pharmacok
Slide 13: Target Timeline for RI-002 Milestones
TARGET TIMELINE FOR RI-002 MILESTONES 2014 2015 2016 QL Q2 Q3 Q4 QL Q2 Q3 Q4 | Phase Ill Dosing | Positive Phase III Data | Report Secondary Endpoint Data BLA Filing | FDA Review Period Target Approval / PDUFA Date [El Achieved mitestones Anticipated First Commercial Sales (RI-002) [El Anticipated f
Slide 14: Historical Data Overview
HISTORICAL DATA OVERVIEW
Slide 15: Summary of Historical Data
SUMMARY OF HISTORICAL DATA LABORATI ¢ Cotton Rat Model - Treatment & Prevention of RSV Infection + Normal, Immune Competent + Immune Suppressed
Slide 16: Cotton Rat Protection - Normal Immune System
TON RAT PROTECTION - NORMALIMMUNE SYSTEM NASAL AND LUNG IN THE ADMA I Cotton Rat Lung RSV Viral Load Titers Cotton Rat Nasal RSV Viral Load Titers 1 a Es go [a he Bal i. Fas . Bas. a | I a | = ME Ee ; i oe Ee ay ae iy iat @ ADMA 16 7
Slide 17: RI-002 for the Treatment of RSV in Immune Suppressed Cotton Rat
COTTON RAT! RI-002 FOR THE TREATMENT OF RSV IN IMMUNE SUPPRESSED COTTON RAT! + Treatment of RSV Disease in the Immune Suppressed Cotton Rat + Greater than 99.9% reduction in viral load - Post RSV Infection ial Titer (logo PFU/E) PARMA. 6 6 4 25 23 SAUNE ONLY tow bose roo me coe» 1.200 Low Det = 750m
Slide 18: Cotton Rat Protection - Impaired Immune System
COTTON RAT PROTECTION - IMPAIRED IMMUNESYSTEM Bo 2 ol es ea i : 3 a mn
Slide 19: Cotton Rat Protection - Impaired Immune System
OTTON RAT PROTECTION - IMPAIRED IMMUNE SYSTEM A ADMININSTRATION OF R002 RESTORES THE PULMONARY HISTOLOGY OF R' INFECTED IMMUNE x0 25 i {ee Bs © mmunosuppressed + 002 High Dose Immunesuppressed + RL0O2 Low Dose '-Normal Animals “| 5 PARMA. =
Slide 20: Animal & Laboratory Testing Experience Conclusion
ANIMAL & LABORATORY TESTING EXPERIENCE CONCLUSION: THE COTTON RAT MODEL DEMONSTRATES: ‘Highly significant increases in serum RSV neutralizing titers ‘THE TREATMENT OF IMMUNE geese CALA G USI | *FI-002 reduces systemic dissemination of RSV to peripheral organs DEMONSTRATES: + RI-002 restores the pulm
Slide 21: Commercialization & Market Research Overview
COMMERCIALIZATION & MARKET RESEARCH OVERVIEW
Slide 22: US Commercialization Strategy
US COMMERCIALIZATION STRATEGY Hite small, specialty sales force targeting physicians who identiy infections in Immune compromised patients Immunologists, Infectious Disease, Pulmonologists, Hematologists etc. + ~500 leading specialty programs for trating PIDD patients in the US WII | nie vnson Onn t
Slide 23: Experienced Management Team and Board of Directors
EXPERIENCED MANAGEMENT TEAM A\ BOARD OF DIRECTORS Ul NAME SELECTED CURRENT OR PAST AFFILIATIONS ‘ADAM GROSSMAN lil BRIAN LENZ, CPA hela ‘Chet Financia omicer KPMG B8!0SN) {JAMES MOND. LD. PHD aan i) ‘hat Meester on 'STEVENELMS AISLING DR. JERROLD GROSSMAN . g nbs ITTUNO Newtek LAWRENCE GUIHEEN Baxte
Slide 24: Market Research & Commercialization Planning
MARKET RESEARCH & COMMERCIALIZATION PLANNING ph « LEK. Consulting Engaged to Conduct ~36 Interviews Across a Range of Key Stakeholder Groups as well as a Quantitative Survey of 150 Physicians « Interviewees Include: + Immunologists (n=12) + Infectious Disease Specialists (n=10) + KOL Experts (n=2) *
Slide 25: Market Research & Commercialization Planning
MARKET RESEARCH & COMMERCIALIZATION PLANNING ph Survey Participants were Presented with the Following: « Value Proposition Proposed: + The only intravenous immunoglobulin (IVIG) product containing polyclonal antibodies found in standard IMIG products (e.g., Carimune, Gammagard, Gamunex) as well as s
Slide 26: Market Research Summary
MARKET RESEARCH SUMMARY. » Physicians Reported to be Enthusiastic About R-002 » RI-002 is Expected to Provide Broad Immune Protection to Immune Compromised Patients with PIDD + Offers further optionality for patients who may benefit from a unique antibody profile IMG option + Regular prophylactic tr
Slide 27: Market Research Summary
MARKET RESEARCH SUMMARY. » Both Immunologists and Infectious Disease Specialists + Responded Positively to RI-O02's Overall Immunity Profile = Unique antibody profile - physicians noted that it would likely allow them to treat patients differentially based on patients‘ infection susoeptibiliy profil
Slide 28: ADMA BioCenters Plasma Procurement Overview
ADMA BIOCENTERS PLASMA PROCUREMENT OVERVIEW
Slide 29: Demand for Source Plasma Is Growing
S DEMAND FOR SOUR SELMA Is Bowne __ ES » i eal » Hundreds of Diseases are Treated with Products Made from Human Plasma + Over 19 million liters of source plasma collectedin the US annually + Typical plasma collection center can collect 30,000 to 50,000 liters of source plasma annually + Many countri
Slide 30: ADMA BioCenters Fulfill Important Strategic Goals
ADMABIOCENTERS FULFILL: 33 43i gAL IMPORTANT STRATEGIC GO) + ADMA BioCenters History ADMA + Received FDA BLA approval in August 2014 \ + June 2012 entered into third party multhyear supply agreement + Received GHA (Europe) certification in June 2013 ‘The power is in you! + Received South Korean MFDS
Slide 31: Milestones & Financial Highlights
MILESTONES & FINANCIAL HIGHLIGHTS
Slide 32: Milestones & News Flow
MILESTONES & NEWS FLOW COMPLETED + Signed manufacturing and plasma supply + IPO completed October 2013 ("ADMA") Partnership for RI-O02_ + Expanded ADMA BioCenters network, initiated 2nd + Signedlicensing partnership for Europe and other _—_center build-out & FDA review process ‘foreign territories +
Slide 33: Ownership and Financial Information
OWNERSHIP AND FINANCIAL INFORMATION AS OF SEPTEMBER 30, 2014 ‘SHAREHOLDERS INCLUDE ‘AISLING CAPITAL {AS OF 9/30/2014 FINANCIAL SUMMARY petal 2 oa Cah ch equblerisand sora eset 20271354 Tottasets 25287218 Toutes sis012.268 | Tots ety s9244947 Fee for 2044 (10) 426.008 | ‘onmon shares cusianng oa0.8z3
Slide 34: Corporate Highlights
CORPORATE HIGHLIGHTS: « Focused on Specialty, High-Titer, Human Immune Globulin (1VIG) «+ Pivotal Phase Ill Tial for RI-002 Met Primary Endpoint + No reported Incidence of Serlous Bacterial Infections (SB!) + Met FDA requirement = 1 S81/Patlent-Year » RI-002 - IVIG Lead Product + Novel VG, enriched
ADMA Biologics — Investor Presentation (December 2014) on 6ix