Adma Biologics Inc · NASDAQ:ADMA
Adma Biologics — Investor Presentation (June 2015)
36 slides from Adma Biologics's investor presentation, Jun 24, 2015
Slide 1: Improving Health for the Immune Compromised with Advanced Therapies
Improving Health for the Immune Compromised with Advanced Therapies
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS This document contains forwarclooking statements about ADMA Biologics, Inc. (*we" or the “Company’), including, without limitation, statements that may predict, forecast, indicate, or imply future results, performance or achievements, which may contain the words “estimate,
Slide 3: Corporate Highlights
CORPORATE HIGHLIGHTS « Focused on Specialty, High-Titer, Human Immune Globulins (IVIG) « Pivotal Phase III Trial for RI-O02 Met Primary Endpoint + No reported Serious Bacterial Infections (SBI) + Met FDA requirement < 4 SBI/PatientYear « RI-002 - IVIG Lead Product + Novel IVIG. enriched with standar
Slide 4: Blood & Plasma Composition
ye BLOOD & PLASMA COMPOSITION « 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 protein in plasma + lgG = naturally occurring polyclonal antibodies against bacteria
Slide 5: Sizeable Market — IVIG
SIZEABLE MARKET — IVIG IVIG is Widely Used and Reimbursed for a Variety of On-Label and Evidence-Based Disorders ~$4.4 Billion US Immune Globulin (IG) Market U.S. IVIG market (2009-13) + Intravenous immune globulin (IVIG) is a pooled plasma Billions of dollars product from healthy blood donors, cont
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 Health Organization « Most Bacterial Pneumonias are Preceded by a Viral Upper Respiratory Tract Infection (URTI) + Viral URTI Impairs
Slide 7: RI-002 is Targeted to Immune-Compromised Patients
« 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 Variable Immune Deficiency (CVID) in 25,000 to 4 in 50,000 (7,000-14,000 patients) 30% to
Slide 8: Market Overview - PIDD and Infections
MARKET OVERVIEW - PIDD AND INFECTIONS ¢ Ina Limited and Subjective Survey Conducted on our Behalf, Physicians Polled were Found to have the Following Views Regarding PIDD Patients: + Responding physicians viewed bacterial RSV rankingwithin most Most concemir inet : ee aoa vienna infections as the mo
Slide 9: Sizeable Market - ADMA Products
SIZEABLE MARKET - ADMAPRODUCTS PIDD RISK FACTORS FOR INFE IN: « Type and Severity of Immune Deficiency « Age « Impaired Pulmonary Function + Bronchiectasis + Asthma + History of respiratory infection / Environmental conditions POTENTIAL FOLLOW-ON INDICATION POPULATIONS: « Hematopoietic Stem Cell Tra
Slide 10: How is RI-002 Different Than Other IVIG Products
HOW IS RI-002 DIFFERENT THAN OTHERIVIG PRODUCT: STANDARDIZED, HIGH-LEVELS OF < RSVA « 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 Elevate
Slide 11: Lead Product Candidate (RI-002)
LEAD PRODUCT CANDIDATE (RI-002) RLOO2 Polyclonal IVIG Product Enriched with Standardized, High-Levels of Anti-RSV Antibodies « Efficacy Confirmed - Met Phase III Primary Endpoint “f « Targeted to Immune-Compromised Patients aS ys + Initial indication: Primary Immune Deficiency Disease (PIDD) + Poten
Slide 12: Phase III Data Review
PHASE III DATA REVIEW PRIMARY & SECONDARY OUTCOMES
Slide 13: Positive Data for RI-002 in Phase III Clinical Trial
POSITIVE DATA FOR RI-002 IN PHASE]! 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 Pharmacokinetic Studies t
Slide 14: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Patient Demographics AGE (YEARS) N 59 19 40 MEAN (SE) 41.8 (2.84) 38.6 (4.94) 43.3 (3.48) cS) 21.78 21.53 22.01 MIN, MAX 3,74 5,70 ar. AGE GROUP 2-6 YEARS 2(3.4%) 15.3%) 1 (2.5%) ‘T-LLYEARS 4(6.8%) 15.3%) 3 (7.5%) 12:16 YEARS 5 (8.5%) 16.3%) 4(10.0%) >16 YEARS 48 (81.4%) 1
Slide 15: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Primary Endpoint TOTAL 3 WEEK CYCLE EEK CYCLE Subjects | infusions Subjects | Infusions Subjects | Infusions ae. (N=59) | (l-793) eek (N=19) | (l-294) eet (N=40) | (l-499) ta] 1 (%) n (%) ta] 1 (%) n (%) (a 1 (%) n (%) [2] BI [2] BI [2] B] SERIOUS BACTERIAL INFECTION 9 9 @
Slide 16: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Number of Days Lost from Work/ School/ Day Care Due to Infections and their Treatment TOTAL DAYS MISSED IN THE STUDY 93 27 66 NO. OF DAYS MISSED PER PERSON PER YEAR 1.66 1.56 LU A-SIDED 95% UPPER BOUND 1.97 244 2.09 Dats on file, ADIMA Biologics
Slide 17: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Hospitalizations Due to Infection UMMARY TOTAL HOSPITALIZATIONS DUETO INFECTIONS a 0 a NUMBER OF DAYS OF HOSPITALIZATION 5 0 5 HOSPITALIZATIONS PER SUBJECT PER YEAR 0.018 0.000 0.026 Dats on file, ADIMA Biologics 17
Slide 18: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Unscheduled Medical Visits to ER or Physician's Office Due to Infection TOTAL VISITS IN THE STUDY 54 18 36 VISITS PER PERSONPER YEAR 0.966 1.044, 0.933 AL-SIDED 95% UPPER BOUND 1.209 1.533 1.227 Dete on file, ADMA Biologics 18
Slide 19: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Study Drug Related TEAEs* Occurringin >5% of Subjects Total 3-Week Cycle 4-Week Cycle Infusions ‘Subjects | Infusions Infusions Total | (ne59) | ciev7e3) | Tol (eis) | e294) | Total (n=4o) | (499) Preferred Team Events, Events Events a n%) n%) Ps n%) ne) rs n(%) 0%) (21 (3
Slide 20: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Trough IgG (mg/dL) 1500.00 0.00 LOS fs PS 2 FF FS SF SF S ee *s ess fs we aS & & RS s Trial Dosing 3 week - 527.3mg/kg (n=19) Dete on file, ADMA Biologics 4 week - 491.1mg/kg (n=40) : 20 INC
Slide 21: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Maximum Fold Increase in Serum Antibody Neutralizing Titers Achieved in Populations Receiving RI-O02 as Compared to their Baseline Titer Prior to RI-O02 Administration TOTAL (n- Mean Fold increase (s.e) 5.3 (0.54) RSV P Value 0001 Mean Fold Increase (s.e) 3.20.25) H. Influ
Slide 22: Target Timeline for RI-002 Milestones
TARGET TIMELINE FOR RI-O02 MILESTONES ph 2014 2015 | 2016 Q1 Q2 Q3 Q4 Q1 Q2 Q3 4 | Phase III Dosing Positive Phase III Data | Positive Secondary Endpoint Data BLA Filing | FDA Review Period Target Approval / PDUFA Date 1) Achieved milestones Anticipated First Commercial Sales (RI-002) : [0 Anticipat
Slide 23: Commercialization & Market Research Overview
COMMERCIALIZATION & MARKET RESEARCH OVERVIEW.
Slide 24: US Commercialization Strategy
US COMMERCIALIZATION STRATEGY + Hire small, specialty sales force targeting physicians who identify infections in Qysis0 ar) || immune compromised patients + Immunologists, Infectious Disease, Pulmonologists, Hematologists etc. ADDRESSABLE + ~500 leading specialty programs for treating PIDD patients
Slide 25: Experienced Management Team and Board of Directors
EXPERIENCED MANAGEMENT TEAM AND BOARD OF DIRECTO NAME ADAM GROSSMAN Founder, President, CEO & Director BRIAN LENZ, CPA Chief Financial Officer JAMES MOND, M.D., PH.D. Chief Scientific Officer & Chief Medical Officer STEVEN ELMS Chairman Pounder Vee Chatman coc BSc MNO seerk o_o Baxter (rrra KEDRION
Slide 26: Market Research & Commercialization Planning
MARKET RESEARCH & COMMERCIALIZATION PLANNING « L.E.K. 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 27: Market Research & Commercialization Planning
MARKET RESEARCH & COMMERCIALIZATION PLANNING Survey Participants were Presented with the Following: « Value Proposition Proposed: + The only intravenous immunoglobulin (IVIG) product containing polyclonal antibodies found in standard IVIG products (e.g., Carimune, Gammagard, Gamunex) as well as stan
Slide 28: Market Research Summary
MARKET RESEARCH SUMMARY « Physicians Reported to be Enthusiastic About RI-O02 « RI-OO2 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 IVIG option + Regular prophylactic t
Slide 29: 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 susceptibility profil
Slide 30: ADMA BioCenters Plasma Procurement Overview
ADMA BIOCENTERS PLASMA PROCUREMENT OVERVIEW
Slide 31: US Demand for Source Plasma is Growing
US DEMAND FOR SOURCE PLASMAIS GROWING wl « Hundreds of Diseases are Treated with Products Made from Human Plasma + Over 24 million liters of source plasma collected in the US annually + Typical plasma collection center can collect 30,000 to 50,000 liters of source plasma annually + Many countries ut
Slide 32: ADMA BioCenters Fulfill Several Important Strategic Goals
ADMABIOCENTERS FULFILL SEVERAL IMP ORTANTSTRATEGIC GOALS Lia « ADMA BioCenters History ADMA + Received FDA BLA approval in August 2044 AA + June 2042 entered into third party multiyear supply agreement + Received GHA (Europe) certification in June 2013 The power is in yout + Received South Korean MF
Slide 33: Milestones & Financial Highlights
MILESTONES & FINANCIAL HIGHLIGHTS
Slide 34: Milestones Flow
=WS FLOW + Signed manufacturing and plasma supply partnership for RI-O02 IPO completed October 2013 (“ADMA") Signed licensing partnership for Europe and other foreign territories Expanded ADMA BioCenters network, initiated 2nd center build-out & FDA review process Obtained foreign approval for ADMA
Slide 35: Ownership and Financial Information
OWNERSHIP AND FINANCIALINFORMATION SHAREHOLDERS INCLUDE Aisling Capital Broadfin Capital Biomark Capital Consonance Capital Grossman Family Fidelity Biotechnology Fund Franklin Templeton Biotechnology Fund J. Goldman & Co. PointState Capital Telemetry Investments Weiss Multi-Strategy Advisers, LLC A
Slide 36: Corporate Highlights
CORPORATE HIGHLIGHTS « Focused on Specialty, High-Titer, Human Immune Globulins (IVIG) « Pivotal Phase III Trial for RI-O02 Met Primary Endpoint + No reported Serious Bacterial Infections (SBI) + Met FDA requirement < 4 SBI/PatientYear « RI-002 - IVIG Lead Product + Novel IVIG, enriched with standar