Adma Biologics Inc · NASDAQ:ADMA
Adma Biologics — Investor Presentation (January 2013)
25 slides from Adma Biologics's investor presentation, Jan 7, 2013
Slide 1: ADMA Biologics, January 2013
@ADMA.. January 2013
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 th
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 7 Business Segments e Drug Development e Plasma Collection - ADMA BioCenters plasma collection facilities fulfill k
Slide 4: Overview
Overview 7 Lead drug product candidate e Novel IGIV, specialized preparation 7 Well-established Phase III regulatory path e Obtained FDA clearance for IND to initiate Phase IT study 7 Near-term clinical milestones 7 Sizeable market opportunity 7 Revenue generating FDA licensed plasma collection faci
Slide 5: Experienced Management Team and Board of Directors
Experienced Management Team and Board of Directors / Management Team 7 Adam Grossman Founder, Drector, President and CEO /Brian Lenz, CPA Chief Financial Officer James Mond, M.D., Ph.D. Ghief Scientific Officer and Chief Medical Officer Board of Directors /Steven Elms aaa NG Charman, t 7Dr. Jerrold
Slide 6: Blood & Plasma Composition
Blood & Plasma Composition 7 Blood contains: plasma, red cells, white cells, platelets 7 Plasma contains: protein, water 7 Plasma’s proteins contains: immunoglobulins, coagulation factors, albumin & other therapeutic proteins Protein 7% ona NN White Cells & Platelets 8% + ADMA's lead drug product ca
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, ca
Slide 8: Sizeable Market Opportunity - IGIV
Sizeable Market Opportunity - IGIV 7 ~~$3.5Bn - US IGIV Total Market “© in Billions 7 Used to treat US IGIV Sales in Billions e Primary immune deficiencies 85 7 e Autoimmune diseases 3.0 Immunocompromised patients e Neuropathy = s20 7 Growth drivers m8 7 e New indications si0 + © New research and da
Slide 9: Lead Product Candidate (RI-002)
Lead Product Can DM ate (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: = Hematopoietic stem
Slide 10: Sizeable Market Opportunity - RI-002
Sizeable Market Opportunity — RI-002 4 ~~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 4 ~~25,000 HSCT procedures performed in the US each year 4 ~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 immunocompromised patient populations © 7 RSV-infected HSCT patients have poor prognosis: e 41% of untreated patients progress to lower respiratory tract
Slide 12: RI-001 Phase II Trial Results
RI-001 Phase II Trial Results a> 7 Randomized, double-blind, placebo-controlled trial in RSV- infected*, immunocompromised subjects (n=21) 7 Primary endpoint: Statistically — 4-fold rise in RSV antibody titer from baseline vs. placebo e ITT population - Mean: 9.78 fold RSV antibody titer increase (d
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: Lead Product Candidate: RI-002 Manufacturing
Lead Product Candidate 7 RI-002 is manufactured using same FDA approved contract manufacturing facility as RI-001 7 Improved yields over RI-001 7 Improved stability profile 7 Comparable anti-RSV potency PARMA... q) 14
Slide 15: RI-002 Regulatory Pathway to BLA Approval
RI-002 regulatory pathway to BLA approval is welFestabpneg ) 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 Phase I
Slide 16: RI-002 Phase III Trial Design
RI-002 Phase III Trial is efficient & manageable in a) Patient Population = Primary Immune Deficiency Disease (PIDD) Primary Endpoint = *Serious infection rate per person-year of < 1 Secondary Endpoint = Safety # Patients _ i 60-70 - _ _ _ | Treatment Duration = 12 months * 30 days beyond final dose
Slide 17: Growth Strategy
Growth Strategy ¢ ) 7 Follow-on specialty IGIV products can provide additional growth e In-licensed — VZIG (varicella zoster immune globulin, Biotest AG) for United States and Canada 7 Infectious disease specific IGIV product candidates e Targeted at immunocompromised transplant patients e Managemen
Slide 18: Over million liters of source plasma collected in the US
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 from plasma collected at US approved source plasma ce
Slide 19: 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 25 400 360 20 300 15 250 = 10 10 100 A 50 ° ° 2008 2006 2007 2008 2009 2010 2011 2012 2005 2008 2007 2008 2009 2010 2011 2012est The U
Slide 20: ADMA BioCenters fulfill several important strategic goals
MA Bio Centers fu several important strategic g 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 with Biotest AG 7 Ownership of source plasma is a strategic asset e Plasma collection centers prov
Slide 21: Plasma collection centers generate meaningful revenues
Centers fulfill several important stra 7 Plasma collection centers generate meaningful revenues e A base business which is currently revenue generating e Steady revenues with firm multi-year supply contracts e Additional centers can be opened as demand increases e Asingle plasma center can generate
Slide 22: Achievements: Successfully Raised $17.55M
Achievements 7 Successfully Raised $17.55M February 2012 - Investors = Aisling Capital = Ayer Capital = Burrill Capital = Founders/Management 7 Venture Debt Financing Commitment of $6M with Hercules Technology Growth Capital e $4M received December 2012 e $2M predicated on completion of certain mile
Slide 23: Achievements: Secured Long-Term Manufacturing Agreement
Achievements ) 7 Secured Long-Term Manufacturing Agreement e Biotest Pharmaceuticals Corporation e 10 year agreement with 2 five year extensions e FDA approved manufacturing facility 7 Out/In-License Agreement e Biotest AG e Out-licensed RSV IGIV product for Europe and selected Middle East and North
Slide 24: Timeline - Anticipated Milestones
Timeline — Anticipated Milestones 7 Initiate Phase III Trial ~ 1H 2013 7 Phase III Data ~ 2H 2014 7 FDA BLA Submission ~ 2H 2014 PARMA. 24
Slide 25: ADMA Highlights
DMA Highlights 7 Lead product candidate - RI-002 e Novel IGIV drug product, specialized preparation e Targeting immunocompromised patients 7 Well-established FDA regulatory path to approval e Obtained FDA clearance for IND to initiate Phase III study 7 Market opportunity is sizable 7 Long-term suppl
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