Full Press Release Details
ADMA Biologics Realizing the Potential of Plasma-Derived Therapieswith Groundbreaking
Immunotechnology December 2021 NASDAQ: ADMA
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. and its subsidiaries (collectively, "we," "our" or the "Company"), including, without limitation, statements that may predict,
forecast, indicate, or imply future results, performance or achievements, and may contain the words "estimate," "project," "potential," "possible," "forecast," "intend," "target," "anticipate," "plan," "expect," "believe," "will," "is
likely," "will likely," "should," "could," "would," "may" or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, without limitation, our plans to develop, manufacture,
market, launch and expand our own commercial infrastructure and commercialize our current products and future products; our plans to expand our pipeline with differentiated immune globulin product candidates in development; potential near and
mid-term value creation through certain milestones; the possibility of expanding our product portfolio with additional specialty immune globulin products; product expansions into new fields of use, indications, target populations and product
candidates, and the labeling or nature of any such approvals; our dependence upon our third-party and related party customers and vendors and their compliance with regulatory bodies; our ability to obtain adequate quantities of U.S. Food and
Drug Administration ("FDA")-approved plasma with proper specifications; the likelihood and timing of FDA action with respect to any further filings by the Company; the expected financial, strategic and commercial benefits of the FDA's
approval of our VanRx SA25 Workcell aseptic fill finish machine; results of clinical development; the potential of specialty plasma-derived biologics to provide meaningful clinical improvement for patients living with Primary Immune
Deficiency Disease ("PI"); expected market size growth in the U.S. immune globulin market through 2027; our ability to market and promote our products in the competitive environment and to generate meaningful revenues; our estimated revenue
potential and related timing; certain revenue opportunities; our estimated revenue growth relative to our competitors; our production capacity and yield and ability to increase such capacity and yield; our ability to increase market share and
grow revenue through anticipated product launches as well as expected peak market share; our ability to secure, build and obtain FDA approval for additional plasma collection centers and the timing related thereto; anticipated timing for
achieving plasma supply self-sufficiency; estimated global supply and demand for plasma through 2027; the estimated value of our Boca Raton manufacturing facility; potential clinical trial initiations; potential investigational new product
applications, Biologics License Applications, and expansion plans; our intellectual property position, including our expectations of the scope of patent protection with respect to our products or other future pipeline product candidates; the
achievement of clinical and regulatory milestones; our manufacturing capabilities; third-party contractor capabilities and strategy; our plans relating to manufacturing, supply and other collaborative agreements; potential contract
manufacturing opportunities and sales of our immune globulin products and intermediates; our estimates regarding expenses, capital requirements and needs for additional financing; possible or likely reimbursement levels for our currently
marketed products and estimates regarding market size; projected growth and sales for our existing products as well as our expectations of market acceptance of BIVIGAM and ASCENIV ; future economic conditions and performance;
commercialization efforts relating to our products and the runway and limitation of our available cash; and our ability to identify alternative sources of cash. The forward-looking statements contained herein represent the Company's estimates
and assumptions only as of the date of this presentation, and the Company undertakes no duty or obligation to update or revise publicly any forward-looking statements contained in this presentation, except as otherwise required by the federal
securities laws. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by
these forward-looking statements, including, but not limited to, the continued safety and efficacy of, and our ability to obtain and maintain regulatory approvals of, our current products as well as our plans to increase our supplies of
plasma; our ability to expand our plasma center network; regulatory processes and interpretations of final data of our products and product candidates; acceptability of any of our products for any purpose, by physicians, patients or payers;
concurrence by the FDA with our conclusions and the satisfaction by us of its guidance the risks; and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K,
10-Q and 8-K, and any amendments thereto.
Who We Are ADMA Biologics is an end-to-end commercial biopharmaceutical company committed to
manufacturing, marketing and developing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for infection Our devotion to these underserved
populations fuels us, and we believe our hands-on approach to production and development sets us apart 3
ADMA Investment Highlights Differentiated U.S. Plasma Products Opportunity in a Large &
Growing End-Market 1 Vertically Integrated with Leading Technology, Supply Chain & Production Processes 2 Well-Defined & Largely De-Risked Pathway to Profitability & Unique Scarcity Value 3 Potential Upside Through
Operating Leverage & New Product Pipeline Opportunities 4
Differentiated Opportunity in a Large & Growing Market One of six manufacturers in a
historically undersupplied U.S. IG marketThe only fully vertically integrated U.S.-domiciled fractionator Four major producers (Grifols, CSL Behring, Shire and Octapharma) collectively account for >94% of U.S. IG marketExisting competitors
are at or near capacity; ADMA is in early stages ofits growth and production ramp-up ADMA is 1 of 6 Manufacturers in a Growing,Supply-Constrained U.S. Immunoglobulin (IG) Market Comprehensive suite of three U.S. FDA-approved commercial IVIG
products: Standard IVIG (BIVIGAM), including a range of vial sizes and configurations Hyperimmune IG portfolio, comprised of ASCENIV and Nabi-HBASCENIV is a novel IG and the only product in its class produced by blending normal plasma with
hyperimmune plasma using ADMA's patented methods Nabi-HB has been used for over 20 years to protect against hepatitis B infection among newly exposed individuals ADMA Has Three FDA-Approved Products& Diversified Revenue
Streams ~$9.5Bn in 2020 Growing to $17Bn+ U.S. IG Market Source: The Plasma Proteins Market In The United States 2020, Marketing Research Bureau Inc., July 2021 Six diversified revenue streams with the potential to add a seventh with
third-party CMO fill-finish capabilities 1
Vertically Integrated with Leading Technology,Supply Chain & Production Processes Contractually
obligated third-party supply agreements expected to complement and bridge to plasma supply self-sufficiency by YE202310+ FDA-licensed plasma collection facilities anticipated to be fully FDA approved by YE2023Well-positioned infrastructure to
support near term revenue growth and ensure continuity of product supply into the supply-constrained U.S. IG market End-to-end control of supply chain from plasma collection through plasma fractionation, purification, fill-finish and
testingAmong an elite group of U.S.-based biologic drug manufacturers with comprehensive in-house control of critical manufacturing and testing functions Operating in cGMP compliance with validated methodsSuccessful implementation of supply
chain enhancements largely de-risks production scale-up and growth outlook FDA approved In-house aseptic fill-finishing capabilities Ongoing exploration of potentially accretive third-party fill-finish opportunities VanRx anticipated to
meet all internal production needs with additional idle capacity, potentially adding new third-party revenues Plasma Supply Self-Sufficiency Anticipated by YE2023 End-to-End Control of Supply Chain In-House Fill-Finish Functions
Manufacturing Raw Material Collections Filling & Packaging Release & In-Process Testing 2
Well-Defined and De-Risked Pathway to Profitability& Unique Scarcity Value Capital
requirements, regulatory approvals and manufacturing lead time prohibit manufacturers from quickly increasing output and filling demand in end-market supplyUnique and complex manufacturing process with a long production cycle (7-12
months)Market demand forecasted to outpace industry supply for the foreseeable future Strict regulatory requirements for plasma-derived therapeutics governed by the FDA and state health departmentsValidation, product registration and
ultimate commercialization takes ~3 to 5+ years - all current and complete ADMA operates in cGMP compliance across its manufacturing footprint as per recent FDA inspections and approvals ADMA estimates, based upon publicly disclosed
fractionator transactions, Boca Plant valuation estimated at $400M+ and ~5 years to complete registrations, clinical trials and construction of a cGMP-compliant fractionation plant and fill-finish facility of equivalent capacity to
ADMA's Complex Manufacturing Process Validated and U.S. FDA Approved Adhere to Strict RegulatoryRequirements With Data,Compliant SOPs and Processes In-Place Significant Scarcity Valuefor ADMA's Plant ADMA acquires the Boca Raton facility
and all rights to BIVIGAM JUNE2017 ADMA works diligently to bring manufacturing facility into FDA compliance FDACompliance JULY2018 ADMA successfully obtains FDA approval for the optimized manufacturing process for
BIVIGAM MAY2019 Source: Wall Street research FDA Biologics inspection completed; achieved VAI compliance status AUG2021 FDACompliance 3
Potential Upside Through Operating Leverage & New Product Pipeline Opportunities Well-defined
pathway to $300M+ revenues by 2025Fastest revenue growth profile forecasted within theplasma therapeutics landscape Potential capacity upside with modest capital investment requirements Expected to benefit from market share gains as well as
end-marketIG growth IP issued to screen hyperimmune donors, tailor compositionsand form plasma pools - IP protection through 2035Attractive label expansion opportunities for specialty IGs targeting patient populations with high unmet need;
robust and growing IPestate to support exploration of additional indicationsPublished data supports potential evaluation of ASCENIV in immune-compromised patients infected with or at-risk for respiratory syncytial virus (RSV) infection and
other respiratory viral pathogens in primary and secondary immune-deficient populations Fractionation Facility Has 600,000 L Annual Plasma Processing Capacity, Supporting a ~$300M+ Revenue Opportunity Robust and Growing IP Estate to Support
Potentially Attractive New Product Opportunities ADMA's Patented Immunotechnology Screen and identify high-titer RSV plasma donorsHyperimmune donors with sufficient antibodies to select pathogens are
identified Tailoredcompositions Tailored plasma poolsare derived from a unique blend of normal source plasma and plasma obtained from the selected donors Proprietarytesting A proprietary microneutralization assay
quantitatively measures titer levels of neutralizing RSV antibodies in plasma donor samples 4
ADMA Offers a Multi-Faceted Revenue-Generation Platform IG production and processing
(including protein intermediates) Source Plasma Supply CMOActivities $300MAnnual RevenuePotential Existing infrastructure supports manufacturing and commercial product opportunitiesto generate multiple meaningful sources of revenue
collectively amounting to $300M Plasma protein intermediate paste sales to 3rd parties Contract manufacturing and laboratory services; potentially additive 3rd party CMO revenue opportunities following 2021 Fill-Finish approval ADMA
BioCenters provides source plasma to 3rd parties Three FDA-approved and marketed IG products; additional plasma-derived product candidates in development
PLASMA PRODUCTS PORTFOLIO COMMERCIAL Opportunities:
Plasma Therapeutics Introduction to Plasma-Derived Therapies and Immunoglobulins (IG) ADMA's
optimized IG manufacturing process and validation for intermediate fractions allows for the potential to maximize revenue from each liter of plasma while producing life-sustaining and saving therapies Plasma-derived therapeutics are
essential,life-sustaining biologic drugs that replace absent proteins due to genetic and acquired disorders in hundreds of thousands of patients in the U.S. Many of these naturally occurring proteins are unable to be replaced by new,
innovative therapiesMany patients require long-term treatments and some potentially for their entire life Immunoglobulins (IG) or Intravenous Immune Globulins (IVIG) are pooled plasma-derived products from healthy plasma donors, containing
a range of polyclonal antibodies against common pathogens (e.g., bacteria, fungi and viruses)Only 6 companies currently produce IVIG approved for the U.S. market, including CSL Behring, Grifols, Takeda, Octapharma, BPL and ADMAOther
therapeutic products made from plasma proteins include: albumin, coagulation factors, alpha-1 and C-1 esterase, among others 45%Red and white Blood Cells and
Platelets 55%Plasma 90%Water 7%Protein 3%Others 60%Albumin 15%IgG 24%Others 1%Factor VIII Immunoglobulins (IG)
Plasma IG Market Is Sizeable & Growing Current $9.5Bn US IG market expected to grow to $17.2Bn
by 2027 Aging PopulationGeriatric population more susceptible to rare diseases treatable by IG products Global population of 65+ expected to nearly double by 2050Rise of Use of IGs in MedicineSurge in awareness related to treatment of rare
diseases with IG productsWidening scope of indications treatable with IG productsImproved Diagnostics Improvements in diagnostics leading to increased rates of PI diagnosesCondition remains under-diagnosed; average PI diagnosis still takes
12.4 yearsIncreased Use of Immunosuppressive TherapeuticsIncreased utilization of immuno-oncology agents and other immunosuppressive therapeutics necessitating antibody supplementationIncrease in Number of Plasma Collection CentersGrowing
number of plasma collection centers worldwideIncrease in public and private associations that spread awareness and information related to plasma collections Drivers of IG Market Growth Source: Marketing Research Bureau, 2020 U.S.
Fractionation Market Report, ADMA internal analysis1. The Plasma Proteins Market In The United States 2020, Marketing Research Bureau Inc., July 20212. Others include Kedrion and BPL $Bn ADMA's peak production capacity could garner a
~1.5-2.5% share of the market at scale (2) ~$9.5Bn US IG Market in2020 Set to Grow to $17Bn+(1) Market Share of US IG Producers
In a 40 year study of 473 patients with PI on standard IVIG (3) Potential Higher-Risk Target
Populations (1) Despite Decades of IG Use, Improved Therapies Still Needed PI is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system due to either a lack of necessary antibodies or a
failure of these antibodies to function properlyEstimated prevalence of 1:1,200 in the U.S., or approximately 250,000 peopleNIH estimates 500,000 undiagnosed PI patients in the U.S.Over 400 genetic defects are responsible for PIPatients
typically receive monthly outpatient infusions of IVIG therapyWithout this exogenous antibody immune support, these patients would be susceptible to a wide variety of infectious diseases ~10% Volume Growth Projected for IG to Treat PI
(6) Primary Immunodeficiency is a Significant Market Opportunity Primary Immunodeficiency (PI) Overview (1) Class Est. Incidence (U.S.) Est. Prevalence Common variable immune deficiency (CVID) 1 in 25,000 to 1 in 50,000 2,000 to 5,000
patients Severe combined immune deficiency (SCID) syndrome ~100 new cases each year 500-1,000 patients on IVIG post-transplant Wiskott-Aldrich syndrome (WAS) ~4 in every 1,000,000 males 600 patients on IVIG therapy DiGeorge syndrome
(DGS) 1 in 4,000 births 1,000 patients on IVIG therapy Ataxia telangiectasia (AT) 1 in 40,000 to 1 in 100,000 3,000 to 8,000 patients X-linked hyper IgM deficiency (XHMD) 2 in every 1,000,000 males 350 patients on IVIG
therapy X-linked agammagobulinanemia (XLA) 1 in 10,000 3,500 patients more susceptible to viral infections Source: ADMA information, on file, AAAAI, FDA, Product prescribing information, United Healthcare, Aetna, L.E.K. Consulting
research and analysis Despite standard IG therapy, patients continue to experience recurrent respiratory infection and chronic lung disease (2)(3) 90% developed chroniclung disease (5) developed bronchiectasis (5) PI is a prevalent and
under-diagnosed disorder long-treated with IG therapy,but a continual need for improved options remains experienced recurrent respiratory tract infection (4) 29% 11% 2015 2017 IG Volume Growth By Indication 2020 2030 IG Volume Growth
By Indication 1. Centers for Disease Control, National Institute of Health 2. The broad spectrum of lung diseases in primary antibody deficiencies. Eur Respir Rev. 2018.3. Morbidity and mortality in common variable immune deficiency over 4
decades. 4. The lung in primary immunodeficiencies: New concepts in infection and inflammation. Front Immunol. 2018.5. Subclinical infection and dosing in primary immunodeficiencies. Clin Exp Immunol. 2014.6. Wall Street research
IG is Widely Used and Reimbursed Across Payer Mix FDA-approved use and evidence-based use is
consistently expanding across therapeutic areas FDA-Approved Uses*Primary immunodeficiency (PI)Multifocal motor neuropathyB-cell chronic lymphocytic leukemiaImmune thrombocytopenic purpuraKawasaki syndromeChronic inflammatory
demyelinatingpolyneuropathy Possible Additional Reimbursed Evidence-Based Uses Acquired red cell aplasiaBone marrow transplantationDermatomyositisEnteroviral meningoencephalitisEstablished bacterial sepsisMultiple sclerosis Multiple
myelomaMyasthenia gravisNeonatal hemochromatosisParvovirus B19Pediatric HIVPost transfusion purpura Rasmussen's syndromeRenal transplant from liver donorSolid organ transplantationStaphylococcal toxic shockSystemic lupus erythematosusToxic
epidemal necrolysis *Source: ADMA information, on file, AAAAI, FDA, Product prescribing information, United Healthcare, Aetna, L.E.K. Consulting research and analysis. Not all uses approved for all IG products by FDA.
BIVIGAM Overview The Reintroduction of BIVIGAMRESULTS FROM ADMA'S STRONG EXECUTION AND REGULATORY
EXPERTISE IN A 1-YEAR STUDY OF PATIENTS WITH PI,BIVIGAM met all primary endpoints (1)(2) * Target was 1 SBI / year; 99% CI of 0.136 SBI / patient/year; of 63 adult patients in the enrolled in the study, 58 were included in