Adma Biologics Inc · NASDAQ:ADMA
Adma Biologics — Investor Presentation (March 2015)
36 slides from Adma Biologics's investor presentation, Mar 2, 2015
Slide 1: Jimigroving rlacilen for tne lmmitine Comororil
Jimigroving rlacilen for tne lmmitine Comororil with Advanced Terioies Darived from chime Persie
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS This document contains forward-looking statements about ADMA Biologics, Inc. ("we" or the “Company', including, without limitation, statements that may predict, forecast, indicate, ar imply future results, performance or achievements, which may contain the words “estimate,
Slide 3: Corporate Highlights
CORPORATE HIGHLIGHTS « Focused on Specialty, High-Titer, Human Immune Globulins (VIG) « Pivotal Phase III Trial for RI-OO2 Met Primary Endpoint + No reported Serious Bacterial Infections (SEI) + Met FDA requirement < 4 SBI/Patient-Year « Rl-002 - IVIG Lead Product + Novel IVIG, enriched with standar
Slide 4: Blood & Plasma Composition
BLOOD & PLASMA COMPOSITION « Blood Contains: Plasma, Red Cells, White Cells, Platelets » Plasma Contains: Protein, Water « Plasma’s Proteins Contain Many Therapeutic Benefits + IVIG is made from a key therapeutic protein in plasma + IgG = naturally occurring polyclonal antibodies against bacteria, f
Slide 5: Sizeable Market - IVIG
SIZEABLE MARKET - IVIG IVIG is Widely Used and Reimbursed for a Variety of On-Label and Evidence-Based Disorders ~$4.4 Billion US Immune Globulin (IG) Market U.S. IVIG market (2009-13) + Intravenous immune globulin (IVI) is a pooled plasma Billions of dollars product from healthy blood donors, conta
Slide 6: Sizeable Market - Incidence of Infections and RSV
SIZEABLE MARKET - INCIDENCE OF INFECTIONS AND RSV « Lower Respiratory Tract Infection is the Most Common Infectious Cause of Death in the World + Stated by the World Health Organization « Most Bacterial Pneumonias are Preceded by a Viral Upper Respiratory Tract Infection (URTI} + Viral URTI Impaits
Slide 7: RI-002 Targeted to Immune-Compromised Patients
bal « RI-002 is Targeted to Immune-Compromised Patients « Initial Indication Patient Target: Primary Immune Deficiency Disease (PIDD) * 250,000 PIDD Patients in the US, 50% are Treated with IVIG (~125,000) EST. INCIDENCE CESS (Us POPULATION) Common Variable Immune Deficiency (CVID) ‘Lin 25,000 to 4
Slide 8: Market Overview - PIDD and Infections
MARKET OVERVIEW - PIDD AND INFECTIONS Ina Limited and Subjective Survey Conducted on our Behalf, Physicians Polled were Found to have the Following Views Regarding PIDD Patients: + Responding physicians viewed bacterial RSV ranking within most | Most concemin, siete an 5 bd 6 infections as the most
Slide 9: Sizeable Market - ADMA Products (Cont'd)
SIZEABLE MARKET - ADMA PRODUCTS (CONT’D) PIDD RISK FACTORS FOR INFECTION: ¢ Type and Severity of Immune Deficiency « Age ¢ Impaired Pulmonary Function + Bronchiectasis + Asthma + History of respiratory infection / Environmental conditions POTENTIAL FOLLOW-ON INDICATION POPULATIONS: ¢Hematopoietic St
Slide 10: How Is RI-002 Different Than Other IVIG Products?
HOW IS RI-002 DIFFERENT THAN OTHER IVIG PRODUCTS? STANDARDIZED, HIGH-LEVELS OF STANDARD IVIG « Meets FDA Requirements for IVIG Products + Donor pool size > 1,000 + Minimum titers to certain infectious agents - release testing specifications + Polyclonal antibodies meet FDA requirements « Standardize
Slide 11: Lead Product Candidate (RI-002)
LEAD PRODUCT CANDIDATE (RI-002) 02 Polyclonal IVIG Product Enriched with Standardized, High-Levels of Anti-RSV Antibodies « Efficacy Confirmed - Met Phase III Primary Endpoint “f z « Targeted to Immune-Compromised Patients aS + Initial indication: Primary Immune Deficiency Disease (PIDD) + Potential
Slide 12: Phase III Data Review
PHASE IW DATA REYIEYY PRIMARY? “4 SECONDARY OUTCOMES
Slide 13: Positive Data for RI-002 in Phase III Clinical Trial
POSITIVE DATA FOR RI-O02 IN PHASE III CLINICAL TRIAL Pivotal Phase III Trial Met Primary Endpoint « RI-002 Prevented Serious Bacterial Infections like Bacterial Pneumonia, Osteomyelitis and Bacterial Sepsis Trial was based on: FDA’s “Guidance for Industry: Safety, Efficacy and Pharmacokinetic Studie
Slide 14: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Patient Demographics _— — Total 3-Week Cycle 4-Week Cycle Characteristic/Statistics | (cubjects=59) eaves {Subjects-40) Age (years) N 59 19 40 | Mean (SE) 41.8 (2.84) 38.6 (4.94) 43.3 (3.48) sD 21.78 21.53 22.01 Min, Max 3,74 5,70 3,74 Age Group 2-6 years 2 (3.4%) 1(5.3%)
Slide 15: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Primary Endpoint Total 3-Week Cycle 4-Week Cycle | Subjects Infusions Subjects Infusions Subjects Infusions pol, | (W=59) (15793) AOL (wet9) | (1=294) TON | (w=40) (12499) ay | 806) 6) | YEAS (v6) | mcs) | IS | m3) | m0) 2 Bl 2a) Bl a Bl Serious Bacterial Infection 0 i) 0
Slide 16: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Number of Days Lost from Work/ School/ Day Care Due to Infections and their Treatment Statistics (Siibjense85) pabeeuty paitacupe) ‘Total days missed in the study 93 27 66 No. of days missed per person per year 1.66 156 471 1-sided 95% Upper Bound 197 244 2.09 Data on file
Slide 17: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Hospitalizations Due to Infection Summary tziesa Total 3-Week Cycle | 4-Week Cycle NY SLERORY, (Subjects=59) | (Subjects=19) | (Subjects=40) ‘Total Hospitalizations due to infection ee 0 5 Number of days of Hospitalization S 0 5 Hospitalizations per subject per year 0.018
Slide 18: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Unscheduled Medical Visits to ER or Physician’s Office Due to Infection Summary Category Unscheduled Medical Visits Due to Infection Total (Subjects=59) 3-Week Cycle (Subjects=19) 4-Week Cycle (Subjects=40) Total Visits in the study 54 18 36 Visits per person per year 0.96
Slide 19: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Study Drug Related TEAEs! Occurring in >5% of Subjects Total 3-Week Cycle 4-Week Cycle refered Tem | rat ese in| eg SE Is mS nn n(%) | n(%) n(%) | n(%) n(%) — n(%) sues eS 55 26(44.1) 39(4.9) | 22 |10(526)| 17(58) 33-16 (40.0), 22(4.4) Headache 10 | 8(136)| 100.3) | 3—| 3(
Slide 20: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Trough IgG (mg/dL) 1500.00 1000.00 PIII FDA Guidance - target of 500mg/dL ‘Mean (¢ SE) 500.00 0.00 & “v > a A J A & 2 J wd a7 2 FP EEC EF ESS EE SSF ES SF FF FEF EF EF EF SC SF EF SF SF FFL LK KK MK LK HK LK LK LK LK FF Ss Ro s Trial Dosing: 3 week — 527.3mg/kg (n=19) Data
Slide 21: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Maximum Fold Increase in Serum Antibody Neutralizing Titers Achieved in Populations Receiving RI-002 as Compared to their Baseline Titer Prior to RI-002 Administration Total (n=31)* Mean Fold Increase (s.e) 5.3 (0.54) RSV Pvalue 0001 Mean Fold Increase (s.e) 3.2 (0.25) H.
Slide 22: Target Timeline for RI-002 Milestones
TARGET TIMELINE FOR RI-O02 MILESTONES fi 2014 201 2016 Qt Q2 Q3 Q4 QL Q2 Q3 04 | Phase III Dosing Positive Phase III Data Positive Secondary Endpoint Data BLA Filing | FDA Review Period Target Approval / PDUFA Date 1) Achieved milestones Anticipated First Commercial Sales (RI-002) : [By anticipated
Slide 23: Commercialization: Market Research Overview
CONMERGIALIZNTION <4 MARMET RESSARGr OVERYIEYY
Slide 24: US Commercialization Strategy
US COMMERCIALIZATION STRATEGY + Hire small, specialty sales force targeting physicians who identify infections in (WavANmSeNy| immune compromised patients + Immunologists, Infectious Disease, Pulmonologists, Hematologists etc. ADDRESSABLE Fear - ~500 leading specialty programs for treating PIDD pati
Slide 25: Experienced Management Team and Board of Directors
EXPERIENCED MANAGEMENT TEAM AND BOARD OF DIRECTORS NAME SELECTED CURRENT OR PAST AFFILIATIONS ADAM GROSSMAN eS Feo eases sche ll 2 os kh BRIAN LENZ, CPA Chief Financial Officer KPMG @8i08ny = ¥CorMedix JAMES MOND, M.D., PH.D. Chiet Scientific Officer & cess Chief Medical Officer wryeps> STEVEN ELMS
Slide 26: Market Research & Commercialization Planning
MARKET RESEARCH & COMMERCIALIZATION PLANNING ¢ L.E.K. Consulting Engaged to Conduct ~36 Interviews Across a Range of Key Stakeholder Groups as well as a Quantitative Survey of 150 Physicians ¢ Interviewees Include: « Immunologists (n=12) Infectious Disease Specialists (n=10) KOL Experts (n=2) Payer/
Slide 27: Market Research & Commercialization Planning
MARKET RESEARCH & COMMERCIALIZATION PLANNING Survey Participants were Presented with the Following: éValue Proposition Proposed: <The only intravenous immunoglobulin (IVIG) product containing polyclonal antibodies found in standard IVIG products (€.g., Carimune, Gammagard, Gamunex) as well as standa
Slide 28: Market Research Summary
MARKET RESEARCH SUMMARY ¢ Physicians Reported to be Enthusiastic About RI-002 « RI-002 is Expected to Provide Broad Immune Protection to Immune Compromised Patients with PIDD + Offers further optionality for patients who may benefit from a unique antibody profile IVIG option + Regular prophylactic t
Slide 29: Market Research Summary
MARKET RESEARCH SUMMARY ¢ Both Immunologists and Infectious Disease Specialists Responded Positively to RI-002’s Overall Immunity Profile Unique antibody profile - physicians noted that it would likely allow them to treat patients differentially based on patients’ infection susceptibility profiles P
Slide 30: ADMA BioCenters: Plasma Procurement Overview
ADMA SIOGENTERS PLASMA PROCURESNIENT OVERYIEVY
Slide 31: Hundreds of Diseases Are Treated with Products Made from Human Plasma
600 500 400 300 200 ¢ Hundreds of Diseases are Treated with Products Made from Human Plasma + Over 24 million liters of source plasma collected in the US annually + Typical plasma collection center can collect 30,000 to 50,000 liters of source plasma annually + Many countries utilize US plasma for t
Slide 32: ADMA BioCenters History
ADAG Bio The power is in you! ADMA BioCenters History Received FDA BLA approval in August 2014 June 2042 entered into third party multi-year supply agreement Received GHA (Europe) certification in June 2013 Received South Korean MFDS Approval September 2014 Ownership of Source Plasma is a Strategic
Slide 33: Milestones & Financial Highlights
NUEESTONES <4 FINANCIAL rileiriUleirirs
Slide 34: Milestones & News Flow
MILESTONES & NEWS FLOW COMPLETED + Signed manufacturing and plasma supply + IPO completed October 2013 (“ADMA”) Partnership for R002 + Expanded ADMA BioCenters network, initiated 2nd + Signed licensing partnership for Europe and other center build-out & FDA review process foreign territories + Phase
Slide 35: Ownership and Financial Information
OWNERSHIP AND FINANCIAL INFORMATION SHAREHOLDERS INCLUDE Aisling Capital Biomark Captial Broadfin Capital Consonance Capital Fidelity Biotechnology Fund Franklin Templeton Biotechnology Fund Grossman Family $10 Capital Cash, cash equivalents and short-term investments $20,271,154 Total assets $25,28
Slide 36: Corporate Highlights
CORPORATE HIGHLIGHTS « Focused on Specialty, High-Titer, Human Immune Globulins (VIG) « Pivotal Phase III Trial for RI-OO2 Met Primary Endpoint + No reported Serious Bacterial Infections (SEI) + Met FDA requirement < 4 SBI/Patient-Year « Rl-002 - IVIG Lead Product + Novel IVIG, enriched with standar