Adma Biologics Inc · NASDAQ:ADMA
Adma Biologics — Investor Presentation (September 2016)
35 slides from Adma Biologics's investor presentation, Sep 9, 2016
Slide 1: Corporate Overview September 2016
ADMA BIOLOGICS Advanced Therapies for the Immune Comprot ‘CORPORATE OVERVIEW ‘September 2016 Nasdaq: ADMA WW\MW.ADMABIOLOGICS.COM.
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS ‘ns rcertte cite ost steer’ pst a est naar posta Pt Sete bn Rem A 25 tt AOA, Bes re argh ern tit, sete ewe raw Pere. Sewer ae ‘ais wort pn, corset glo snes seve ox eons ean separ tN meaty ners post ane ttn ann fy ana ay a nyo ery rae oes Aceh tntacewaty oar ptr Seeese mpg
Slide 3: Corporate Highlights
CORPORATE HIGHLIGHTS J Mission’ ‘Committed to developing and commercializing specialty, human Immune Globulin (IG) products, derived from specialty/high-titer plasma donor pools, for immune-compromised Patients at risk for infection J Positive Data + Pivotal Phase Il trial for RI-002 met primary end
Slide 4: Blood & Plasma Composition
BLOOD & PLASMA COMPOSITION J Blood Contains: Plasma, Red Cells, White Cells and Platelets J Plasma Contains: Protein and Water J Plasma Proteins Contain Many Therapeutic Benefits + IMGis made from a key therapeutic protein in plasma: IgG © IgG = naturally occurring polyclonal antibodies against bact
Slide 5: Sizeable Market — Immune Globulin (IG)
SIZEABLE MARKET — IMMUNE GLOBULIN (IG) IG is Widely Used and Reimbursed for a Variety of On-Label and Evidence-Based Disorders ~S4.8 Billion U.S. immune Globulin (IG) Market U.s.16 market (2008-8) “+ navenous mune globulin (6) is» poled lasma ions ot daars oduct tom heathy plasma dora, cotta a ange
Slide 6: Strong Link Between Immune-Compromised Patients and Infections
STRONG LINK BETWEEN IMMUNE-COMPROMISED. PATIENTS AND INFECTIONS Lower Respiratory Trac infection is Among the Most Common Infectious Cause of Death in the World Stated by the World Health Organization ‘Most Bacterial Pneumonias are Preceded by @ Viral Upper Respiratory Tract Infection (URTI) Viral U
Slide 7: PIDD Represents a Significant Market Opportunity
PIDD REPRESENTS A SIGNIFICANT MARKET OPPORTUNITY FOR ADMA 2 RLOODs Targeted to immune-Comnpramised Patients nial ination Patient Target Primary Immune D» Approximately 260,000 PIDO Patients in US, 50% ace Treat ith IG (126,000) 2 IDF 2018 National PIDD Treatment Survey Suoge 60% of PIDD Patents Suff
Slide 8: Market Research — PIDD and Infections
MARKET RESEARCH -— PIDD AND INFECTIONS In Limited and Subjective Survey Conducted on our Behalf, Physicians Polled were Found to have the Following Views Regarding PIDD Patients: CZ © Responding physicians viewed GOSRtIN) bacterial infections as the most ME) concerning infection in PIDD patients ‘©
Slide 9: Market Research — PIDD Target Patient Population Specifics
MARKET RESEARCH — PIDD TARGET PATIENT POPULATION SPECIFICS PIDD - Risk Factors for Infection + Type and severity of immune deficiency » Age + Impaired pulmonary function — Bronchiectasis = Asthma History of respiratory infection/environmental conditions = Chronic lung disease 2013 IDF National PIDD
Slide 10: ADMA's IP - How Is RI-002 Different Than Other IG Products?
ADMA'‘S IP - HOW IS RI-002 DIFFERENT THAN OTHER IG PRODUCTS? NORMAL SOURCE PLASMA DONORS HIGH-TITER RSV ANTIBODY PLASMA DONORS J Meets FDA Requirements for IVIG Products = Donor pool size > 1,000 © Minimum tters to certain infectious agents — release testing specifications, © Polyclonal antibodies m
Slide 11: Lead Product Candidate Summary
LEAD PRODUCT CANDIDATE SUMMARY Polyclonal IG Product Enriched by Using a Plasma Pool Derived from Blending High-Titer RSV Donors and Normal Source Donors “ J — Targeted to immune-compromised patients ~ Phase Il primary efficacy endpoint was achieved aS -lntal indication: PIDD -RI-002 may offer clini
Slide 12: ADMA Pipeline
ADMA PIPELINE Potential Follow-On Indication Populations After Initial FDA Approval, ADMA May Seek to Expand the Label for RI-002 to ‘Address These Populations’ Unmet Medical Needs Regarding RSV Infection » HSCT — ~25,000 procedures/year performed in the U.S. © Solid Organ Transplant (lung, heart, l
Slide 13: Regulatory Update & Phase III Data Review
BIOLOGICS ADMA 6’ Regulatory Update & Phase Ill Data Review September 2016
Slide 14: Regulatory Update
REGULATORY UPDATE J BLA Submitted and Accepted for Filing by FDA 30 2015 ‘© Positive Phase Ill trial achieved primary endpoint ‘© Safety and efficacy data confirmed 2 CRL Received from FDA 30 2016 ‘© CRL did not mention the need for any new trials or additional data ‘© Letter identified, among other
Slide 15: Positive Data for RI-002 in Phase III Clinical Trial
POSITIVE DATA FOR RI-002 IN PHASE II CLINICAL TRIAL J Pivotal Phase Ill Trial Achieved Primary Endpoint © RI-002 prevented serious bacterial infections such as bacterial pneumonia, ‘osteomyelitis and bacterial sepsis, J Trial was Based on: © FDA's “Guidance for Industry: Safety, Efficacy and Pharmac
Slide 16: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW ‘Age (Years) N ® ry 0 Moan (SE) a1seaH) 335 494) 63048) =o 278 153 zo Nn Max 3m 5.70 3.74 ‘Age Group 26 Yeats 20.4%) 163%) 125%) Tot Yas «Bex 163%) 395%) 1246 Years 5p 5%) 163%) 400%) 16 Ye 8 B14) we @2%) 200%) Sex ae 28 475%) 7 68%) 21 625%) Female 31.625%) 12632%) 194758
Slide 17: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Primary Endpoint ‘Total Subjects Infusions, Subjects Infusions... Subjects. Infusions (N58) (792) (N19) (294) (N40) (490) Events N (6) NO) EVES easy) EME NG) NG) Serious Bacterial eee o 0 0 ° ° ° ° 0 0 “kasi ten eed We bce, te close oe tbc eum a Yer ces Dats one ADA Boots
Slide 18: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Number of Days Lost from Work | School Day Care Due to Infections Total Days Mised inthe Study 33 z ny No. Days Missed Pet Petson Pe Ve 16 18 a {Sided 95% Upper Bound 17 2 208 Hospitalizations Due to Infection “Tetl Hosptszatins Duet nections 1 a 1 Number of Days of Hospit
Slide 19: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Study Drug Related TEAEs Occurring in >5% of Subjects FP PP Pree Team ite, | Se eras) en, oS Mea a, | a’ et Supe /Invsions win | os fasaany|s3@m| 2 |roeee)|1765)| 33 |r aoo)| 24) Fade [ema oea] 3 [seen] ana [7 [seas] 700 Adverse Drug Reaction 4 36.1) | 405) o 0 o 4 3@5) |
Slide 20: Clinical Trial Data Review
CLINICAL TRIAL DATA REVIEW Trough IgG (mg/dL) = RR i 0000 FDA Guidance — target of 500mg/dL GOTT TTT dE 3weok~ 527 3mg/ka (n=19) 4 weok— 491 tmgig (n=40) Dats one ADA Boots
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 ‘Mean Fold increase (6.8) 53(054) RSV PVaue oot r ae ‘Mean Fold increase (6.6) 3240.25) PVaue 00% _ ‘Mean Fold
Slide 22: Commercialization & Market Research Overview
ADMA 6’ BIOLOGICS Commercialization & Market Research Overview September 2016
Slide 23: U.S. Commercialization Strategy
U.S. COMMERCIALIZATION STRATEGY aaa Immunologists & Infectious Disease Physidans-Marketto hosp, physician canis ander speci eae paces wroteatinmne compronied PIPPI co in suppor otvatuenasedmartet access strategie fr coding andcoverape + Dosser and reimbursement suppor programs | May useaneterk of at
Slide 24: Experienced Management Team and Board of Directors
EXPERIENCED MANAGEMENT TEAM AND BOARD OF DIRECTORS Brian Lenz, CPA Chet cel Ofer KPMG: ‘James blond, M.D. PHD Chet ede Ofer ‘S Steven Elms AISLING reel CAPLET Dr. Jerold Grossman a Foon Vee Chetan con &. Lawrence Guiheen ret Baxter Ere Richman eer Bambee Dov Goldstein, M.D. AISLING et CAPITAN Bryant
Slide 25: Core Commercial Team
CORE COMMERCIAL TEAM Real World Experience and Successful Track Record with Infectious Disease, Immunology and Plasma Products James Hauert ‘SVP Commercializetion & Strategy + Formerly, Baxter - IVIG and plasma products launch experience Alan Erck VP Sales and National Accounts “Formerly Horizon Pha
Slide 26: Market Research & Commercialization Planning
MARKET RESEARCH & COMMERCIALIZATION PLANNING © LE.K. Consulting engaged to conduct ~36 interviews across a range of key stakeholder ‘groups as well as a quantitative survey of 150 physicians © Interviewees included: = Immunologists (n=12) ~ Infectious Disease Specialists (n=10) = KOL Experts (n=2) —
Slide 27: Market Research Summary
MARKET RESEARCH SUMMARY J 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 optionaliy for patients who may benefit from a unique antibody profile IMG option ~ RI-002's unique antibod
Slide 28: Market Research Summary
MARKET RESEARCH SUMMARY J Immunologists and Infectious Disease Specialists “© Physicians expect the highest adoption of RI-002 within PID patients <5 years of age, ‘as well as potential use among other immune compromised patients with chronic lung conditions ‘© Due to the standardization in manufact
Slide 29: ADMA Biocenters Plasma Procurement Overview
ADMA BIOLOGICS ADMA Biocenters Plasma Procurement Overview September 2016
Slide 30: U.S. Demand for Source Plasma Is Growing
U.S. DEMAND FOR SOURCE PLASMA IS GROWING Hundreds of Diseases are Treated With Products Made From Human Plasma ‘Over 24 milton Iters of source plasma collacted in he U.S. annually ‘Typical plasma collection canter can colsct 30,000 to 60,000 liters of source plasma annually ‘Many counts uti US. plas
Slide 31: ADMA BioCenters Fulfill Several Important Strategic Goals
ADMA BIOCENTERS FULFILL SEVERAL IMPORTANT STRATEGIC GOALS ADIVIA@: ‘The powers in you! J ADMA BioCenters © 2 Approved FDA, GHA and Korean MFDS BioCenters J Ownership of Source Plasma is a Strategic Asset ‘© Plasma collection centers provides self-sourced raw material © Reduces exposure to market flu
Slide 32: Milestones & Financial Highlights
BIOLOGICS ADMA 6 Milestones & Financial Highlights September 2016
Slide 33: Milestones
MILESTONES, ‘Completed ‘© Phase Ill study: Positive primary endpoint data announced ‘© Secondary endpoint results announced from Phase Ill clinical trial ‘© BLA submitted to FDA for RI-002, with positive Phase ill data ‘© ULS. patent granted for compositions and methods for the treatment of immunode
Slide 34: Financial Information
FINANCIAL INFORMATION ‘Cash, cash equivalents and short-term investments $23.8M Total assets $317 Total iabilties s278M ‘otal stockholders’ equity $3.9M Revenus (1H 2016) saan ‘Commen shares autstanding 120M Fully clluted shares outstanding 14™
Slide 35: Corporate Highlights
CORPORATE HIGHLIGHTS J Mission’ ‘Committed to developing and commercializing specialty, human Immune Globulin (IG) products, derived from specialty/high-titer plasma donor pools, for immune-compromised Patients at risk for infection J Positive Data + Pivotal Phase Il trial for RI-002 met primary end
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