Full Press Release Details
ADMA Biologics Realizing the Potential of Specialty Biologicswith Groundbreaking
Immunotechnology January 2024 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 our FDA- approved 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; 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; future financial guidance; 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; estimated global supply and demand for plasma; 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; 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
Who We Are: A Specialty Biologics Company ADMA Biologics is an end-to-end
commercial biopharmaceutical company committed to manufacturing, marketing and developing specialty biologics for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for infection 3 ADMA
Biologics is an end-to-end BioPharma company leading the way as a producer of specialtyplasma-derived biologics Three FDA-approved products: ASCENIV (Immune Globulin Intravenous, Human-slra) BIVIGAM (Immune Globulin Intravenous,
Human) NABI-HB (Hepatitis B Immune Globulin, Human) Intellectual Property: Patents and proven immunotechnology that has forged a new path forward in improving the lives of the immune compromised and other patients at risk for
infection. Contract manufacturing: Full suite of CDMO and contract manufacturing organization (CMO) opportunities. Partner with us for your clinical-stage or commercial aseptic filling, packaging requirements, and our unique good
manufacturing practice (GMP) testing Optimized manufacturingprocesses: Robust, sustainable, and controlled manufacturing process for producing our commercially available plasma-derived products Plasma collection network: 10 state-of-the-art
FDA-licensed facilities dedicated to the collection of human plasma equipped with experienced clinicians and credentialed staff for plasma collection and donor care Corporate HeadquartersRamsey, NJ Manufacturing FacilityBoca Raton, FL 650
DIFFERENTIATION VERTICAL INTEGRATION ASSET DURABILITY UPSIDE STRONG BALANCE
SHEET Differentiated U.S. Specialty Biologics Opportunity in a Large and Growing End-Market Vertically Integrated Supply Chain with Innovative Technology and Production Processes Unique Scarcity Value and Asset Durability Potential
Upside Through Pipeline Products and Production Yield Enhancements Strong Balance Sheet and Top Tier Earnings Growth Outlook DIFFERENTIATION - VERTICAL INTEGRATION - IP - ASSET DURABILITY/SCARCITY PIPELINE - YIELD ENHANCEMENT - FORECASTED
GROWTH High Growth, Profitable BioPharma Company Driving Innovation in the Specialty Biologics Market ADMA Investment Highlights
Differentiated Opportunity in a Large & Growing Market One of six
manufacturers in a historically undersupplied U.S. IG market The 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
market Existing 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-HB ASCENIV is a unique IG and the only product in its class produced
by blending normal plasma with hyperimmune plasma using ADMA's patented methods Nabi-HB protects against HBV infection among newly exposed individuals Three FDA-Approved Products& Six Diversified Revenue Streams U.S. IG Market: ~$10.5Bn
Growing to $20Bn+ Source: The Plasma Proteins Market In The United States 2022, Marketing Research Bureau Inc., October 2022 1 15-22 CAGR 12% ADMA is 1 of 6 Manufacturers in a Growing,Supply-Constrained U.S. Immunoglobulin (IG)
Market ADMA Offers a Multi-Faceted Revenue-Generation Platform
In-House Fill-Finish Functions Vertically Integrated Supply Chain with
Innovative Technology& Production Processes 10 plasma collection facilities FDA licensed Contractually obligated third-party supply agreements expected to supplement the growing internal plasma collections Well-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
testing Among 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 methods Successful 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 SA25 Workcell
anticipated to meet all internal production needs with additional idle capacity, potentially adding new third-party revenues Plasma Supply Self-Sufficiency End-to-End Control of Supply Chain Manufacturing Raw Material Collections Filling
& Packaging Release & In-Process Testing 2
Unique Scarcity Value and Asset Durability Capital requirements, regulatory
approvals and manufacturing lead time prohibit manufacturers from quickly increasing output and filling demand in end-market supply Unique 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 departments Validation, 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 JUNE 2017 ADMA works diligently to
bring manufacturing facility into FDA compliance FDACompliance JULY 2018 ADMA successfully obtains FDA approval for the optimized manufacturing process for BIVIGAM MAY 2019 Source: Wall Street research FDA Biologics inspection
completed; achieved VAI compliance status AUG 2021 FDACompliance 3
Potential Upside Through Production Yield Enhancementsand New Product Pipeline
Program Current plant infrastructure supports well-defined pathway to $370M+ revenues by 2025 Advancing initiative to capture additional IG production yields from same quantities of starting plasma Significant upside potential from
production yield enhancement,if successful Expected to benefit from market share gains as well as end-marketIG growth Issued IP for commercial product to screen hyperimmunedonors, tailor compositions and form plasma pools IP protection
through 2035 Attractive new product and label expansion opportunities for specialty IGs targeting patient populations with high unmet need. S. pneumonia hyperimmune patent estate extends into 2037 Published data supports potential evaluation
of ASCENIV in immune-compromised patients and other respiratory viral pathogens in primary and secondary immune-deficient populations Current Capacity Supports ~$370M+ 2025 Revenue; Upside Potential from Production Yield
Enhancements Potential Hyperimmune Globulin Pipeline Expansion ADMA's Patented Immunotechnology 4 Screen and identify high-titer RSV plasma donors Hyperimmune 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
Strong Balance Sheet & Top Tier Earnings Growth Outlook Strong Balance Sheet
Supports Capital Allocation Optionality Revenue Growth Driving Top-Tier Earnings Outlook Screen and identify high-titer RSV plasma donors Hyperimmune 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 5 2024 Guidance: $MM
Commercial Opportunities: PLASMA PRODUCTS PORTFOLIO NASDAQ: ADMA
Plasma Therapeutics Introduction to Plasma-Derived Therapies and Immunoglobulins
(IG) ADMA's optimized IG manufacturing process supports 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 therapies Many 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 ADMA Other 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 Market Is Sizeable & Growing Current $10.5Bn U.S. IG market expected to
grow to $20Bn+ by 2030 Aging Population Geriatric population more susceptible to rare diseases treatable by IG products Global population of 65+ expected to nearly double by 2050 Rise of Use of IGs in Medicine Surge in awareness related
to treatment of rare diseases with IG products Widening scope of indications treatable with IG products Improved Diagnostics Improvements in diagnostics leading to increased rates of PI diagnoses Condition remains under-diagnosed; average
PI diagnosis still takes 12.4 years Increased Use of Immunosuppressive Therapeutics Increased utilization of immuno-oncology agents and other immunosuppressive therapeutics necessitating antibody supplementation Increase in Number of Plasma
Collection Centers Growing number of plasma collection centers worldwide Increase in public and private associations that spread awareness and information related to plasma collection Drivers of IG Market Growth Source: Marketing Research
Bureau, 2022 U.S. Fractionation Market Report, ADMA internal analysis 1. The Plasma Proteins Market In The United States 2022, Marketing Research Bureau Inc., October 2022 2. U.S. IG Market Share by Revenue according to IQVIA (Sept.
2022) $Bn ADMA's peak production capacity could garner a ~1.5-2.5%+ share of the market at scale ~$10.5Bn U.S. IG Market in2022 Set to Grow to $20Bn+(1) Market Share of U.S. IG Producers(2) 15-22 CAGR 12%
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 properly Estimated prevalence of 1:1,200 in the U.S., or approximately 250,000 people NIH estimates 500,000 undiagnosed PI patients in the U.S. Over 400 genetic defects are
responsible for PI Patients typically receive monthly outpatient infusions of IVIG therapy Without 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
ASCENIVTM Overview THE PRODUCTION OF ASCENIV ONLY IVIG PRODUCT MANUFACTURED
USING PATENTED DONOR SCREENINGAND PLASMA POOLING METHODS (1) IN A 1-YEAR STUDY OF PATIENTS WITH PI, ASCENIV reported zero serious bacterial infections (SBIs)* * SBIs were defined as a rate of <1.0 cases of bacterial pneumonia,
bacteremia/septicemia, osteomyelitis/septic arthritis, visceral abscess and bacterial meningitis per person-year PPPY = per patient per year. Patients and physicians can count on ASCENIV to reduce infection-related quality-of-life
impact Zero hospitalizations due to infection One patient from the study group was hospitalized because of a postoperative local wound infection from elective surgery <1 unscheduled medical visits PPPY 24 out of 59 patients (41%) had a
total of 54 unscheduled medical visits due to infections 1.7 missed days of work / school / activity PPPY due to infection 23 patients (39%) had a total of 93 missed days of work / school / activity due to infections out of a total of 21,535