Adma Biologics Inc · NASDAQ:ADMA
Adma Biologics — Investor Presentation (September 2015)
35 slides from Adma Biologics's investor presentation, Sep 9, 2015
Slide 1: Advanced Therapies for the Immune Compromised
ADMA_, BIOLOGICS Advanced Therapies for the Immune Compromised WWW.ADMABIOLOGICS.COM
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS This presentation contains “forward-looking statements", pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. Cwe" or the "Company", including, without imitation, statements that may pre future results,
Slide 3: Corporate Highlights
CORPORATE HIGHLIGHTS Focused on Specialty, High-Titer, Human Immune Globulins (IG) BLA Filed with FDA July 31, 2015 Pivotal Phase III trial for RI-O02 met primary endpoint RI-002 - IVIG Lead Product Novel IVIG, enriched with standardized, high-levels of anti-RSV antibodies Well-established FDA regul
Slide 4: Blood & Plasma Composition
BLOOD & PLASMA COMPOSITION J Blood Contains: Plasma, Red Cells, White Cells, Platelets J Plasma Contains: Protein, Water J Plasma’s Proteins Contain Many Therapeutic Benefits e IMIG is made from a key therapeutic protein in plasma » IgG = naturally occurring polyclonal antibodies against bacteria, f
Slide 5: Sizeable Market — IG
SIZEABLE MARKET — IG IG is Widely Used and Reimbursed for a Variety of On-Label and Evidence-Based Disorders ~$4.8 Billion US Immune Globulin (IG) Market U.S. 1G market (2009-14) © Intravenous immune glabulin (1G) is a pooled plasma Billions of dollars, product from healthy plasma donors, containing
Slide 6: Sizeable Market — Incidence of Infections and RSV
SIZEABLE MARKET — INCIDENCE OF INFECTIONS AND RSV J S) Lower Respiratory Tract Infection is the Most Cornmon Infectious Cause of Death in the World Stated by the World Health Organization Most Bacterial Peumonias are Preceded by a Viral Upper Respiratory Tract Infection (URTI) Viral URTI impairs the
Slide 7: Sizeable Market — PIDD
SIZEABLE MARKET- PIDD J RI-002 is Targeted to Immune-Compromised Patients J Initial Indication Patient Target: Primary Immune Deficiency Disease (PIDD) J 250,000 PIDD Patients in the US, 50% are Treated with IG (~125,000) Est. Incidence Canaene, Target Population (US Population) Numbers Common Varia
Slide 8: Market Overview — PIDD and Infections
MARKET OVERVIEW — PIDD AND INFECTIONS In aLimited and Subjective Survey Conducted on our Behalf, Physicians Polled were Found to have the Following Views Regarding PIDD Patients: RSV Ranking : a - panent saint GEE : Most Responding physicians viewed Types Concerning ieee bacterial infections as the
Slide 9: Sizeable Market — ADMA Products
SIZEABLE MARKET — ADMA PRODUCTS PIDD Factors for Infection e Type and severity of immune deficiency « Age « Impaired pulmonary function, chronic lung disease - Bronchiectasis - Asthma - History of respiratory infection / environmental conditions Potential Follow-On In jon Populati: ns « Hematopoieti
Slide 10: How Is RI-002 Different Than Other IG Products?
HOW IS RI-002 DIFFERENT THAN OTHER IG PRODUCTS? Meets FDA Requirements for IVIG Products e Donor pool size > 1,000 e Minimum titers to certain infectious agents — release testing specifications e Polyclonal antibodies meet FDA requirements Standardized Elevated Levels of RSV Neutralizing Antibodies
Slide 11: Lead Product Candidate (RI-002)
LEAD PRODUCT CANDIDATE (RI-002) Polyclonal IG Product enriched with standardized, high-levels of anti-RSV antibodies - Efficacy confirmed - met Phase III primary endpoint nf - Targeted to immune-compromised patients x z Initial indication: Primary Immune Deficiency Disease (PIDD) S29 Potential follo
Slide 12: Phase III Data Review: Primary & Secondary Outcomes
ADMA BOL eGiecs Phase Ill Data Review _ 7 Primary & Secondary Outcomes September 2015
Slide 13: Positive Data for RI-002 in Phase III Clinical Trial
POSITIVE DATA FOR RI-002 IN PHASE III CLINICAL TRIAL BLA Filed with FDA July 31, 2015 Pivotal Phase III Trial Met Primary Endpoint e RI-002 prevented serious bacterial infections like bacterial pneumonia, osteomyelitis and bacterial sepsis J Trial was Based on: e FDA's “Guidance for Industry: Safety
Slide 14: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Patient Demograp! 4.Week Cycle (Subjects~40) Age (Years) N 58 19 40 Mean (SE) 41.8 284) 38.6 (4.94) 43.3 G48) sD 21.78 21.53 22.01 Min, Max 3,74 5,70 371 Age Group 26 Years 28.4%) 163%) 1 @5%) 711 Yeats 46.8%) 163%) 37.5%) 12-16 Years 565%) 163%) 4.(10.0%) >16 Years 48 (81
Slide 15: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Primary Endpoint Subjects Infusions 744) Subjects Infusions 4) Subjects. Infusions (N59) (15793) 2, (N=19) (e204) (N=40) (1-499) Ty (NIG) NG) TONG) NG) NI) NM) 2] BI] 2] BI] 2] BI) Total Events Serious Bacterial inaction 0 0 0 0 0 0 0 0 0 *& serious infection is defined by
Slide 16: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Number of Days Lost from Work / School / Day Care Due to Infections and Treatment Total Week Cycle | 4-Week Cycle (Subjects=59) | (Subjects=19) | (Subjects=40) Total Days Missed in the Study 27 66 No. of Days Missed Per Person Per Year 1.66 1.56 14 1-Sided 95% Upper Bound
Slide 17: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Hospitalizations Due to Infection Summary Catego! Total ‘Week C} 3 feek Cycle ees (Subjects=59) Ges Total Hospitalizations Due to Infections 0 Number of Days of Hospitalization 5 0 5 Hospitalizations Per Subject Per Year 0.018 0.000 0.026 Data on file, ADMA Biologics
Slide 18: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Unscheduled Medical Visits to ER or Physician’s Office Due to Infection eae Total week Cycle week Cycle TYE ate Ory. (Subjects=59) | (Subjects=19) | (Subjects=40) 36 Total Visits In The Study 18 Visits Per Person Per Year 0.966 1.041 0.933 1-sided 95% Upper Bound 1.209 1.5
Slide 19: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Study Drug Related TEAEs1 Occurring in >5% of Subjects Total jeek Cycle jeek Cycle an ee | eo Fee ee Preferred Team Events | es) | Ince) | Evens | Srey | “nea | Everts | Tne) | Sve 2] Bl 2] Bl 2] Bl Subjects Infusionsswith 55 |26441)}a9(49)| 22 |10626)]1768)| 33 | 16 ~40.0
Slide 20: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Trough IgG (mg/dL) 1500.00 =n {PPP POOR i 500.00 FDA Guidance — target of 500mg/dL 0.00 PO & & SXF FF SK SS LPO EES 8 s se Trial Dosing 3 week — 527 3mgikg (n=19) 4 week—491.1mgrkg (n=40) Data on file, ADMA Biologics
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 Baseline Titer Prior to RI-002 Administration Total (n=31)* Mean Fold Increase (3.e) 5.3 (0.54) RSV P Value 0001 Mean Fold Increase (s.e) 3.2 (0.25) H. Influ
Slide 22: Target Timeline for RI-002 Milestones
TARGET TIMELINE FOR RI-002 MILESTONES Positive Phase Ill Data BLA Filing || Target Approval / PDUFA Date || {00} Achieved milestones [By anticipated future mitestones
Slide 23: Commercialization & Market Research Overview
ADMA BOL eGiecs Commercialization & Market Research Overview September 2015
Slide 24: US Commercialization Strategy
US COMMERCIALIZATION STRATEGY ~ Hire small, specialty sales force targeting physicians who identify infectionsin Overall Plan immune compromised patients + Immunologists, Infectious Disease, Pulmonologists, Hematologists etc. Addressable A 4 ; ‘500 leading specialty programs for treating PIDD patien
Slide 25: Experienced Management Team and Board of Directors
EXPERIENCED MANAGEMENT TEAM AND BOARD OF DIRECTORS i Selected Current or Past Affiliations Adam Grossman Founder, President, CEO & Directar Medlnmune ome S g nhs echo nosnrassmecusnes (TI + Brian Lenz, CPA Chief Financial Officer ¥CorMedix- James Mond, M.D., PH.D. es Chief Scientific Officer & swe t
Slide 26: Market Research & Commercialization Planning
MARKET RESEARCH & COMMERCIALIZATION PLANNING e 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/Ho
Slide 27: Market Research Summary
MARKET RESEARCH SUMMARY J Physicians Reported to be Enthusiastic about RI-002 J RI-002 is Expected to Provide Broad Immune Protection to Immune Compromised Patients with PIDD e Offers further optionality for patients who may benefit from a unique antibody profile IVIG option - RI-002’s unique antibo
Slide 28: Market Research Summary
MARKET RESEARCH SUMMARY J Immunologists and Infectious Disease Specialists © Physicians expect the highest adoption of RI-002 within PIDD patients <5 years of age, as well as potential use among other immune compromised patients with chronic lung conditions Due to the standardization in manufacturin
Slide 29: ADMA BioCenters: Plasma Procurement Overview
ADMA BOL eGiecs ADMA Biocenters : Plasma Procurement Overview September 2015
Slide 30: US Demand for Source Plasma Is Growing
US DEMAND FOR SOURCE PLASMA IS GROWING 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 p
Slide 31: ADMA BioCenters Fulfill Several Important Strategic Goals
ADMA BIOCENTERS FULFILL SEVERAL IMPORTANT STRATEGIC GOALS ADMA: > ADMA BoCentr Centers Bio FDA, GHA and Korean MFDS Approved The power is in yout Ownership of Source Plasma is a Strategic Asset e Plasma collection centers provides self-sourced raw material Reduces exposure to market fluctuations in
Slide 32: Milestones & Financial Highlights
ADMA BOL eGiecs Milestones & Financial Highlights September 2015
Slide 33: Milestones & News Flow
MILESTONES & NEWS FLOW Completed © Signed manufacturing and plasma supply partnership for RLOO2 © IPO completed October 2013 (‘ADMA") © Signed licensing partnership for Europe and other foreign territories © Expanded ADMA BioCenters network, initiated 2nd center build-out & FDA review process © Obta
Slide 34: Ownership and Financial Information
OWNERSHIP AND FINANCIAL INFORMATION Shareholders Include Aisling Capital Broadfin Capital PointState Capital Biomark Capital Consonance Capital Telemetry Investments Grossman Family Fidelity Biotechnology Fund Weiss Multi-Strategy Advisers, LLC Franklin Templeton Biotechnology Fund —Alyeska Investme
Slide 35: Corporate Highlights
CORPORATE HIGHLIGHTS Focused on Specialty, High-Titer, Human Immune Globulins (IG) BLA Filed with FDA July 31, 2015 Pivotal Phase III trial for RI-O02 met primary endpoint RI-002 - IVIG Lead Product Novel IVIG, enriched with standardized, high-levels of anti-RSV antibodies Well-established FDA regul
ADMA Biologics — Investor Presentation (September 2015) on 6ix