Adma Biologics Inc · NASDAQ:ADMA
Adma Biologics — Investor Presentation (June 2017)
25 slides from Adma Biologics's investor presentation, Jun 8, 2017
Slide 1: ADMA Biologics: Groundbreaking Immunotechnology, One Connection at a Time
en WWW ADMABIOLOGICS.COM ADMA BIOLOGICS ADMA Biologics Groundbreaking Immunotechnology, One’ Connection at a Time June 2017 Nasdaq: ADMA
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS ‘This presentation contains “fontar-looking statements’, pursuantto the sae harbor provsons ofthe Private Securties Ligation Reform Act of 1995, bout ADMA Biologics, Inc We’ “our" or the “Company” including without imation. statements that may predict forecast indicate or
Slide 3: Who We Are
WHO WE ARE ADMA Biologics is a biopharmaceutical company committed to developing and manufacturing specialty plasma derived products for the immune-compromised and other patients at risk for infection. It is our devotion to these underserved populations that fuels us, and our hands-on approach to pr
Slide 4: Corporate Highlights
CORPORATE HIGHLIGHTS fee COMPLETED STRATEGIC TRANSACTION Acquired certain assets, including FDA-approved plasma products and production facility responsible for the manufacture of our RI-002 product candidate from Biotest Pharmaceuticals Corporation “Ability to control all aspects of RI-002 drug sub
Slide 5: Experienced Management Team and Board of Directors
EXPERIENCED MANAGEMENT TEAM AND BOARD OF DIRECTORS Ns Poname | SELECTED CURRENT OF PAST AFFILIATIONS ‘Adam Grossman Founder, President, CEO & Director Brian Lenz, CPA Chief Financial Officer KPMG Tomes Mond, MO, PRO Chietscentfic fee & eS Chet neaealomer oS —— AISLING chatman AISHING — manmmect quer
Slide 6: Blood & Plasma Composition
BLOOD & PLASMA COMPOSITION Blood Contains: Plasma, Red Cells, White Cells and Platelets Plasma Contains: Protein and Water Plasma Proteins Contain Many Therapeutic Benefits + IVIG is made from a key therapeutic protein in plasma: IgG + IgG = naturally occurring polyclonal antibodies against bacteria
Slide 7: Overview of BPC Asset Acquisition
OVERVIEW OF BPC ASSET ACQUISITION BIOLOGICS nN ADMA & Core assets acquired by ADMA from Biotest Pharmaceuticals Corporation (BPC): + FDA-approved biologics plasma production fractionation facility responsible for RI-002 manufacturing + FDA licensed products including Nabi-HB™ (Hepatitis 8 Immune Glo
Slide 8: Post-Transaction ADMA: Integrated Commercial Company
POST-TRANSACTION ADMA: INTEGRATED COMMERCIAL COMPANY \ Gaia ADMA is one of a handful of vertically integrated plasma products and immune globulin manufacturers in US. + Plasma collection centers + ~400,000L annual peak capacity fractionation plant + Full regulatory, quality and compliance control of
Slide 9: Market Opportunities, Commercial Overview, RI-002 & Pipeline
BIOLOGICS Market Opportunities Commercial Overview, RI-002 & Pipeline Nasdaq: ADMA
Slide 10: Growth Drivers: Plasma Market Is Sizeable
I GROWTH DRIVERS: PLASMA MARKET IS SIZEABLE GEaey IMMUNE GLOBULIN (IG) is a pooled plasma product from ~$6 Billion U.S. Immune Globulin (IG) Market healthy plasma donors, containing a range of polyclonal antibodies against common pathogens (ES, Ye snares: 0008: 381, Billions of dollars IG Is USED TO
Slide 11: IG Is Widely Used and Reimbursed
IG IS WIDELY USED AND REIMBURSED FDA-Approved Uses* Additional Reimbursed Evidence-Based Uses Primary immunodeficiency (PIDD) ‘Acquired red cell aplasia Multiple myeloma Rasmussen's syndrome Pane pr orsen ore Bone marrowtransplantation Myasthenia gravis ele een jonor 1 yt Dermatomyosit Neonatal B-ce
Slide 12: PIDD Is a Significant Market Opportunity for ADMA
PIDD IS A SIGNIFICANT MARKET OPPORTUNITY FOR ADMA RI-002 Potential Target Population ~250,000 PIDD PATIENTS in the US. Class Est. Incidence (U.S.) Target Population 2 Population Numbers Common Variableimmune 1 in 25,000to 1 in 50,000 2,000to 5,000 patients ~50% are treated with 1G Deficiency (CVID)
Slide 13: ADMA Is the Voice of the PIDD Patient
ADMA IS THE VOICE OF THE PIDD PATIENT GEaey + Type and severity of immune deficiency «age + Impaired pulmonary function = Bronchiectasis ~ Asthma — History of respiratory infection/environmental conditions = Chronic lung disease of respondents of PIDD patients reported cd having asthma, they suffer
Slide 14: Commercial Products: Established Brands in an Expanding IG Market
COMMERCIAL PRODUCTS: ESTABLISHED BRANDS IN AN EXPANDING IG MARKET 4. \Bivicany aenns ‘nme Gobi (Hare), 10% aud BIVIGAM™ (mmune Globulin intravenous Human) FDA-Approved protection against serious infections Human intravenous immune globulin, 10% liquid Indicated for the treatment of patients with PID
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Slide 16: Leading a New Paradigm in Immunotechnology: RI-002
LEADING A NEW PARADIGM IN IMMUNOTECHNOLOGY: RI-002 GEaey + Our lead product candidate, RI-002 is being developed for the treatment of PIDD + Completed a pivotal Phase Ill clinical study with positive primary and secondary endpoint(s) data + RI-002is the basis for ADMA’s patented methodology The Dono
Slide 17: ADMA Pipeline
ADMA PIPELINE “4 Potential Follow-On Indication Populations for RI-002 Potential Follow-On Products After initial FDA approval, ADMA may seek to expand the label for By leveraging ADMA's IP, know-how and expertise, we may RI-002 to address these populations’ unmet medical needs seek to expand our pr
Slide 18: Post-Closing - ADMA Products, Pipeline and Ongoing R&D
POST- CLOSING - ADMA PRODUCTS, PIPELINE AND ONGOING R&D Product / Candidate BIVIGAM® \ctivity / Other information Pediatric Indication Ts TE Phase BIA Marketed/ cinia m__| Submitted hase IV a Human, Immunoglobulin intravenous __| Manufacturing Optimization Nabi-HB™ Hepatitis B, Hyperimmune Globulin
Slide 19: Regulatory Affairs Update
Regulatory Affairs Update
Slide 20: ADMA Regulatory Update
ADMA REGULATORY UPDATE BLA Submitted and CRL Received from FDA 3Q Accepted forFilingbyFDA 2016 Aa 2pIS, + CRLdid not mention the need + Positive Phase Ill trial for any new trials or achieved primary endpoint additional data + Safety and efficacy + Letter identified, among other data confirmed thing
Slide 21: Quality Management Systems Remediation Plan for Boca Raton
ADMA plans to institute an appropriate remediation plan for a complete Quality Management Systems overhaul of the Boca Raton, FL manufacturing operations + Engage consultants with subject matter expertise to work side-by-side with ADMA staff to remediate specific Quality Systems + Goal to be ina pos
Slide 22: Milestones & Financial Highlights
Milestones & Financial Highlights
Slide 23: Milestones
MILESTONES 4 Completed Phase Ill study: Secondary endpoint BLA submitted to USS. patent granted FDA approved 2nd BLA filed for RI-002 Completed Positive primary results announced FDA for RI-002, for compositions ADMA BioCenter acquisition of endpoint data from Phase Ill with positive and methods for
Slide 24: Financial Information
FINANCIAL INFORMATION Financial Summary: 3/31/17 Results Cash, cash equivalents and short-term investments, $8.8M Total assets $17.6M Total liabilities $28.4M Total stockholders’ deficiency ($10.8M) Revenue 526M Common shares outstanding 129M Fully diluted shares outstanding 147M Balance sheet impac
Slide 25: Vertical Integration
PLASMA COLLECTION VERTICAL INTEGRATION ABILITY TO SUPPLY 4 PORTION OF THE INTERNAL NEEDS AND SELL TO 3) E & HYPERIMMUNE BILITIES TIES CONTRACT MANUFACTURING & TESTING CURRENT CONTRACT FOR HYPERIMMUNE GLOBULIN MONOCLONAL FACILITY FULL QC LABORATORY