Adma Biologics Inc · NASDAQ:ADMA
Adma Biologics — Investor Presentation (September 2012)
24 slides from Adma Biologics's investor presentation, Sep 11, 2012
Slide 1: ADMA Biologics, Inc.
@AD BIOL VIA ICS, INC September 11, 2012
Slide 2: Forward-Looking Statements
Forward-Looking Statements 7 This document contains forward-looking statements about ADMA Biologics, Inc. (the “Company”). These statements involve known and unknown risks that relate to the Company's future events or future financial performance and the actual results could differ materially from t
Slide 3: Corporate Background
Corporate Background 7 Mission e Develop and commercialize specialized, high-titer, human immune globulins (IGIV) 7 Product Development e Focus on immunocompromised patient populations, some with unmet medical needs 7 Business Segments e Drug Development e Plasma Collection - ADMA BioCenters plasma
Slide 4: Overview
Overview / Lead drug product candidate e Novel IGIV, specialized preparation / Well-established Phase III regulatory path / Sizeable market opportunity 7 Near-term clinical milestones 7 Revenue generating FDA licensed plasma collection facility PARMA, med
Slide 5: Experienced Management Team and Board of Directors
Experienced Management Team and Board of Directors ¢ ) Management Team 7 Adam Grossman Founder, President and CEO 7Brian Lenz, CPA Chief Financial Officer 7James Mond, M.D., Ph.D. Chief Medical & Scientific Officer Board of Directors 7Steven Elms Chairman 7Dr. Jerrold Grossman Founder, Vice Chairman
Slide 6: Blood & Plasma Composition
Blood & Plasma Composition ata % 7 Blood contains DRedcels 2% White ces e Plasma a e Red Cells e White Cells ovate e Platelets com 7 Plasma contains ES e Protein e Water roma / Plasma’s proteins contain Evel le y e Coagulation factors “ components e Albumin e Other therapeutic proteins + ADMA’s lead
Slide 7: Plasma Industry - Background
Plasma Industry - Background 7 Human Plasma has many therapeutic benefits e Contains proteins to treat a wide range of conditions e Key products ~ IGIV -For immune deficiency, neurology applications ~ Factor VIII - treat hemophilia/Von Willebrand, clotting disorders — Albumin — volume expansion, car
Slide 8: Sizeable Market Opportunity - IGIV ~$3.5Bn - US IGIV Total Market
Sizeable Market Opportunity - IGIV 7 ~$3.5Bn - US IGIV Total Market © in Billi 1 Fi Wsedtecest US IGIV Sales in Billions @ Primary immune deficiencies $35 e Autoimmune diseases $30 1 e Immunocompromised patients $2.5 e Neuropathy $2.0 7 Growth drivers as e New indications $1.0 + e New research and d
Slide 9: ADMA's Lead Product Candidate (RI-002)
ADMA’s Lead Product Candidate (RI-002*) ¢ ) 7 RI-002 e Polyclonal IGIV product enriched with standardized, enhanced levels of anti-RSV antibodies 7 Targeted to immunocompromised patients e Initial indication: Primary Immune Deficiency Disease (PIDD) ~— Potential follow-on indications: = Hematopoieti
Slide 10: Sizeable Market Opportunity — RI-002 Primary Immune Deficiency Disease patients
Sizeable Market Opportunity — RI-002 7 ~250,000 Primary Immune Deficiency Disease patients in the US ©) e@ «125,000 PIDD patients in the US are treated with IGIV e ~300,000 PIDD patients worldwide are treated with IGIV 7 ~25,000 HSCT procedures performed in the US each year 7 ~11,000 higher risk sol
Slide 11: Sizeable Market Opportunity — RSV incidence
Sizeable Market Opportunity — RSV incidence ( ) 7 RSV infection is a serious problem for immunocompromised patients 7 ~~5-15% RSV infection rate in inmunocompromised patient populations “ 7 RSV-infected HSCT patients have poor prognosis: e 41% of untreated patients progress to lower respiratory trac
Slide 12: RI-001 Phase II Trial Results
RI-001 Phase II Trial Results ( ) 7 Randomized, double-blind, placebo-controlled trial in RSV- infected*, immunocompromised subjects (n=21) 7 Primary endpoint: Statistically significant 4-fold rise in RSV antibody titer from baseline vs. placebo e ITT population - Mean: 9.78 fold RSV antibody titer
Slide 13: RI-001 Compassionate Use Experience
RI-001 has clinically promising compassionate use expences 7 15 immunocompromised patients received RI-001 from April 2009 through February 2011 through unsolicited requests 7 All patients had confirmed RSV lower respiratory tract infections 7 All patients with serum samples obtained showed a 4-fold
Slide 14: RI-002 Regulatory Pathway to BLA Approval
RI-002 regulatory pathway to BLA approval is welkestab neil ) 7 Based on: e 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) 7 11 cur
Slide 15: RI-002 Phase III Trial Design
RI-002 Phase III Trial is efficient & manageable in 479 Patient Population = Primary Immune Deficiency Disease (PIDD) Primary Endpoint = *Serious infection rate per person-year of < 1 Secondary Endpoint = Safety # Patients = ~60-70 Treatment Duration = 12 months Patient Follow-up = 30 days beyond fi
Slide 16: Growth Strategy
Growth Strategy ¢ ) 7 Follow-on specialty IGIV products can provide additional growth / Infectious disease specific IGIV product candidates e Targeted at immunocompromised transplant patients e@ Management of a chronic viral infection 7 Follow-on products may provide opportunities to leverage our co
Slide 17: U.S. Source Plasma — Growing Worldwide Demand
U.S. Source Plasma — Growing Worldwide Demand ( ) 7 Over 19 million liters of source plasma collected in the US 7 Atypical plasma collection center can collect 30,000 to 50,000 liters of source plasma annually 7 In order to market plasma products in the US, the products must be manufactured only fro
Slide 18: US Source Plasma — Growing Worldwide Demand
US Source Plasma — Growing Worldwide Demand ( ) Number of US-FDA Approved Total US Source Plasma Plasma Collection Centers“) Collections (Millions of Liters) ) 450 25 400 350 20 300 15 250 200 10 150 100 5 50 o oO 2005 2006 2007 2008 2009 2010 2011 2012 2005 =62006 §=62007) 3S 2008 )9= 2009 2010 201
Slide 19: ADMA BioCenters fulfill several important strategic goals
DMA BioCenters fulfill several important strate 7 First ADMA BioCenter opened in metro Atlanta e Received FDA BLA approval in August 2011 e June 2012 entered into third party multi-year supply contract 7 Ownership of source plasma is a strategic asset e Plasma collection centers provide self-sourced
Slide 20: ADMA BioCenters: plasma collection centers generate revenues
ADMA BioCenters fulfill several important strate a 7 Plasma collection centers generate meaningful revenues e A base business which is currently revenue geneaung e Steady revenues with firm multi-year supply contracts e Additional centers can be opened as demand increases e Asingle plasma center can
Slide 21: Achievements and Upcoming Events
Achievements and Upcoming Events ( ) 7 S-1 resale registration statement effective August 2012 / PIPE transaction $17.55M completed February 2012 - Investors = Aisling Capital = Ayer Capital = Burrill Capital = Founders/Management / Anticipated events — Expected IND Phase III submission: Q4 2012 — C
Slide 22: Timeline — Anticipated Milestones
Timeline — Anticipated Milestones / Initiate PIII Trial ~ 1H 2013 / PIII Data ~ 2H 2014 7 FDA BLA Submission ~ 2H 2014 PARMA,
Slide 23: Scientific Advisory Board
Scientific Advisory Board 7 Michael Boeckh, M.D. 7 Roy F. Chemaly, M.D. 7 John DeVincenzo, M.D. 7 Ann R. Falsey, M.D. 7 Christine Koval, M.D. 7 John A. Vanchiere, M.D. 7 Edward E. Walsh, M.D. FRED HUTCHINSON CANCER RESEARCH CENTER MD Anderson x Center sue UNIVERSITY 0f TENNESSEE HEALTH SCIENCE CENTE
Slide 24: ADMA Highlights
ADMA Highlights 7 Lead product candidate - RI-002 e Phase III-ready e Novel IGIV drug product, specialized preparation e Targeting immunocompromised patients 7 Well-established FDA regulatory path to approval 7 Market opportunity is sizable 7 ADMA BioCenters provides e Strategic capability to self-s
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