Adma Biologics Inc · NASDAQ:ADMA
Adma Biologics — Investor Presentation (March 2018)
25 slides from Adma Biologics's investor presentation, Mar 5, 2018
Slide 1: Groundbreaking Immunotechnology, One Connection at a Time
WWW-ADMABIOLOGICS.COM ADMA ADMA Biologics Groundbreaking Immunotechnology, One Connection at a Time March 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 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
Slide 4: Corporate Highlights
CORPORATE HIGHLIGHTS “4 fm COMPLETED STRATEGIC TRANSACTION - COMMER‘ L OPERATIONS *Currently operate a 400,000L capacity FDA-approved plasma products and production facility responsible for the manufacture of our commercial and pipeline products Ability to control all aspects of drug substance manuf
Slide 5: Ensure that warning letter is lifted
nsure that warning letter is lifted ediate the outstanding compliance issues identifie We are FDA inspection ready Anticipate near term FDA inspection Optimize IG manufacturing process Relaunch of Bivigam® in the USS. Resubmission of the BLA for RI-0 subsequent approval Obtain approval of a new plas
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 operatio
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 GEaey IMMUNE GLOBULIN (IG) (eg, Bivigam®) is a pooled plasma ~$6 Bil product from healthy plasma donors, containing a range of polyclonal antibodies against common pathogens ion U.S. Immune Globulin (IG) Market U.S. IG market (2009-15) Billions of dollars IG
Slide 11: Commercial Products: Established Brands in an Expanding IG Market
COMMERCIAL PRODUCTS: ESTABLISHED BRANDS IN AN EXPANDING IG MARKET Bivigam® Z {immine 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 2,000o 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 with positive primary and secondary endpoint(s) data + RI-002is the basis for ADMA’s patented methodology The Dono
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Slide 17: ADMA Pipeline - RI-002
ADMA PIPELINE - RI-002 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
Slide 18: Products
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 R&D Activity / Other Pre- | Phase Phase | Phase BLA Marketed/ Product / Candidate Information clinical | 1 0 tm | Submitted Phase IV Bivigama Pediatric indication MTCIECtUNncOntineeton a Human, Immunoglobulin intravenous Nabi HBS Hepatitis B, Hyperimmune Globu
Slide 20: Milestones & Financial Highlights
Milestones & Financial Highlights Nasdaq: ADMA
Slide 21: Milestones
MILESTONES — Completed Future & Ongoing Objectives 1H18: + Anticipated FDA inspection + Submit PAS for optimized Bivigam® /IVIG manufacturing trial process 2H18: + Respond to CRL and Resubmit BLA for RI-002 + Resume supply of marketed products + Three US. patents granted for compositions and methods
Slide 22: Financial Information
FINANCIAL INFORMATION Financial Summa 2/31/17 Results Cash, cash equivalents and short-term investments. $43.1M Total assets $108.0M Total liabilities $67.7M Total stockholders’ equity $403M Revenue $228M Common stock outstanding 453M Fully diluted common stock outstanding 49.1M Balance sheet impact
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 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 B Immune Glo