Adma Biologics Inc · NASDAQ:ADMA
Adma Biologics — Investor Presentation (September 2018)
25 slides from Adma Biologics's investor presentation, Sep 5, 2018
Slide 1: Groundbreaking Immunotechnology, One Connection at a Time
WWW-ADMABIOLOGICS.COM ADMA ADMA Biologics Groundbreaking Immunotechnology, One Connection at a Time September 2018 Nasdaq: ADMA
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS ‘This presentaton contains “forwaré-ookng statements” pusuant to thesafeharbor provisions ofthe Pvate Secures Liigaton Reform Act of 1995 about ADMA Biologics, Inc wer “our or the “Compan, incuing, without Emitation, statements thet may predict forecast inate, or imply fut
Slide 3: Who We Are
WHO WE ARE ADMA Biologics is a vertically integrated commercial biopharmaceutical company committed to manufacturing, marketing and developing specialty plasma-derived products for the immune- compromised and other patients at risk for infection, It is our devotion to these underserved populations t
Slide 4: Corporate Highlights
CORPORATE HIGHLIGHTS GEaey mam COMPLETED STRATEGIC TRANSACTION IN JUNE 2017 - COMMERCIAL OPERATIONS +Operates a 400,000L capacity FDA-approved plasma products and production facility, and successfully closed- out April 2018 FDA compliance inspection of the facility. Facility status upgraded to “VAI”
Slide 5: Current Near & Mid-Term Objectives
CURRENT NEAR & MID-TERM OBJECTIVES Recent Regulatory Achievements * October 25, 2018 Prescription Drug User Fee Act (PDFUA) target action date for BIVIGAM® relaunch * Successfully closed-out April 2018 FDA compliance inspection of Boca Raton, FL facility * Inspection classification status: Voluntary
Slide 6: Experienced Management Team and Board of Directors
EXPERIENCED MANAGEMENT TEAM AND BOARD OF DIRECTORS Ns NAME SELECTED CURRENT OF PAST AFFILIATIO ‘Adam Grossman Founder, President, CEO & Director Brian Lenz, CPA Chief Financial Officer James Mond, MD, PhD Chiet Scientific Officer & Chief Medical Officer Steven Elms Chairman ORPITAT Pesaleseseichcsai
Slide 7: 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 8: ADMA Is One of a Handful of Vertically Integrated Plasma Products Manufacturers
ADMA IS ONE OF A HANDFUL OF VERTICALLY INTEGRATED PLASMA PRODUCTS AND SPECIALTY IMMUNE GLOBULIN MANUFACTURERS IN THE U.S. + Plasma collection centers + ~400,000L annual peak capacity plasma fractionation and purification plant + Full regulatory, quality and compliance control of all products and ope
Slide 9: Market Opportunities
Market Opportunities Commercial Overview, RI-002 t Pipeline Nasdaq: ADMA
Slide 10: Growth Drivers: Plasma Market Is Sizeable
GROWTH DRIVERS: PLASMA MARKET IS SIZEABLE IMMUNE GLOBULIN (IG) (eg, Bivigam®) is a pooled plasma product from healthy plasma donors, containing a range of polyclonal antibodies against common pathogens IG IS USED TO IG WIDELY IG UTILIZATION TREAT A WIDE MARKETED INCREASING VARIETY OF INTHE U.S. DUET
Slide 11: Commercial Products: Established Brands in an Expanding IG Market
COMMERCIAL PRODUCTS: ESTABLISHED BRANDS IN AN EXPANDING IG MARKET BIVIGAM® a (immune Globulin intravenous Human) FDA-Approved protection against serious infections <Bivicam + Human intravenous immune globulin, 10% liquid (Homer, 10% Lud Indicated for the treatment of patients with PIDD Contains a wi
Slide 12: 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 Multifocal motor neuropathy Bone marrow transplantation Myasthenia gravis nes transplant from liver y Neonata
Slide 13: 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 14: 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 ; of respondents of PIDD patients reported —History of respiratory infection/environmental conditions reported having asthma they suffer from chronic ~ C
Slide 15: 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, met primary endpoint and reported positive secondary endpoint(s) + RI-002is the basis for ADMA’s patented methodolog
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Slide 17: ADMA Pipeline
ADMA PIPELINE Potential Follow-On Indication Populations for RI-002 After initial FDA approval, ADMA may seek to expand the label for RI-002 to address these populations’ unmet medical needs regarding RSV infection management + HSCT/Bone Marrow Transplant — ~25,000 procedures/year performed in the U
Slide 18: Expanding Product Portfolio with Additional Specialty IG Products
By leveraging ADMA's IP, know-how and expertise, we may seek to expand our product portfolio with additional specialty IG products by building upon our core competency of identifying high-titer plasma donors and plasma products manufacturing expertise
Slide 19: ADMA Products, Pipeline and Ongoing R&D
ADMA PRODUCTS, PIPELINE AND ONGOING R&D Product / Candidate BIVIGAM® R&D Activity / Other Information Pediatric Indication / Pre Phase dinical | 1 Phase | Phase BLA Marketed/ W tm | Submitted Phase IV a Human, Immunoglobulin intravenous __| Manufacturing Optimization Nabi HBS Hepatitis B, Hyperimmun
Slide 20: Milestones & Financial Highlights
Milestones & Financial Highlights Nasdaq: ADMA
Slide 21: Milestones
MILESTONES Completed in Last Twelve Months + Successfully closed-out April 2018 FDA inspection + Inspection classification status: VAI + Submitted PAS for optimized BIVIGAM® /IVIG manufacturing process, received PDUFA target date of October 25, 2018 + Extinguished 8.6 million shares of non-voting co
Slide 22: Financial Information
FINANCIAL INFORMATION Financial Summa 6/30/18 Results Cash, cash equivalents and short-term investments. $55.2M Total assets $1178M Total liabilities $66.0M Total stockholders’ equity $518M Revenue $8.7M Common stock outstanding 46.3M Fully diluted common stock outstanding 511M a
Slide 23: 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
Slide 24: Appendix
WWW-ADMABIOLOGICS.COM q ADMA APPENDIX Nasdaq: ADMA
Slide 25: Overview of BPC Asset Acquisition
OVERVIEW OF BPC ASSET ACQUISITION ADMA BIOLOGICS nN ©) 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 Gl
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