UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 1, 2021
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(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number, including area code: (201 ) 478-5552
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(Former name or former address, if changed since last report.)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions
(see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter)
or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised
financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01 |
Regulation FD.
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ADMA Biologics, Inc., a Delaware corporation (the “Company”) hereby furnishes the Corporate Presentation the Company expects to present, in whole or in part, and
possibly with modifications, from time to time in connection with presentations to potential investors, strategic partners, industry analysts and others. The Corporate Presentation is attached hereto as Exhibit 99.1 and is incorporated by reference
herein, and is available under the “Company Information” tab in the “Investors & Media” section of the Company’s website, located at www. admabiologics.com.
By filing this Current Report on Form 8-K and furnishing the information contained herein, the Company makes no admission as to the materiality of any information in
this report that is required to be disclosed solely by reason of Regulation FD.
The information contained in the Corporate Presentation is summary information that is intended to be considered in the context of the Company’s Securities and
Exchange Commission (“SEC”) filings and other public announcements that the Company may make, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in
this report, except as may be required by the federal securities laws, although it may do so from time to time as its management believes is warranted. Any such updating may be made through the filing of other reports or documents with the SEC,
through press releases or through other public disclosure.
The information furnished pursuant to this Current Report on Form 8-K, including Exhibit 99.1 hereto, shall not be considered “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into future filings by the Company under the Securities Act of 1933, as amended, or
under the Exchange Act, unless the Company expressly sets forth in such future filings that such information is to be considered “filed” or incorporated by reference therein.
| Item 9.01 |
Exhibits.
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(d) Exhibits
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Exhibit No.
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Description
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ADMA Biologics, Inc. December 2021 Corporate Presentation.
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104
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Cover Page Interactive Data File (formatted as Inline XBRL)
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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December 1, 2021
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ADMA Biologics, Inc.
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By:
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/s/ Brian Lenz
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Name:
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Brian Lenz
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Title:
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Executive Vice President and Chief Financial Officer
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Exhibit 99.1
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
efficiency analysis PPPY= per patient per year. Demonstrated protection from serious bacterial infections (SBIs) 0.037 rate of SBIs per year*During the 12-month study period, 2 serious acute bacterial infections occurred in 2 patients with
an onset date between the first infusion of BIVIGAM and the first follow-up visit197 total infections in 58 patients were reported (3.7 infections PPPY)86% of patients were administered antibiotics (39.1 days PPPY) Reduced
health-related burdens Low rate of hospitalizations (0.21 days / PPPY)2 patients (3.4%) hospitalized for a total of 11 days (0.06%)Fewer missed days of school / work (2.3 days / PPPY)21 patients (36%) with total of 122 days (0.6%) ADMA
acquires Boca Raton manufacturing facility and all rights to BIVIGAM and Nabi-HB June2017 ADMA works diligently to optimize production processes and bring the facility into FDA compliance; achieved VAI status FDA
Compliance July2018 ADMA obtains FDA approval for manufacturing BIVIGAM; first commercial sales in August 2019 May2019 Ongoing reintroduction of BIVIGAM well-received in a high-demand IG market Plasma-derived IVIG that contains a
broad range of antibodies similar to those found in normal human plasmaIndicated for the treatment of patients with primary immunodeficiency (PI)ADMA received FDA approval for manufacturing BIVIGAM in May 2019 and recorded first commercial
sale in August 2019 Approved and Reintroduced in May 2019by ADMA Production of BIVIGAM is voluntarily suspended by previous owner due to manufacturing and compliance issues Production Suspended Dec2016 1. BIVIGAM Prescribing
Information. Boca Raton, FL: ADMA Biologics; 20192. A new intravenous immunoglobulin (BIVIGAM) for primary humoral immunodeficiency. Expert Rev Clin Immunol. 2014. FDA Biologics inspection completed; achieved VAI status
Aug2021 FDA Compliance BIVIGAM: FDA-Approved Protection Against Serious Infections Proven Efficacy in Treating Patients with PI
ASCENIVTM Overview THE PRODUCTION OF ASCENIVONLY 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-yearPPPY = per patient per year. Patients and physicians can count on ASCENIV to reduce infection-related quality-of-life impactZero hospitalizations due to
infectionOne patient from the study group was hospitalized because of a postoperative local wound infection from elective surgery<1 unscheduled medical visits PPPY24 out of 59 patients (41%) had a total of 54 unscheduled medical visits due
to infections1.7 missed days of work / school / activity PPPY due to infection23 patients (39%) had a total of 93 missed days of work / school / activity due to infections out of a total of 21,535 patient days (<0.5%)32.9 days of
antibiotic use PPPY37 patients (63%) used antibiotics due to infection (includes therapeutic use) Potential additional target populations across patients at risk for RSV infection,including in organ transplants and chemotherapy Novel
IVIG with differentiation based on patented methods for donor selection and pooling process blending normal source and hyperimmune RSV plasma Indicated for the treatment of patients with primary immunodeficiency (PI)ADMA received FDA approval
in April 2019 and recorded first commercial sale inOctober 2019 Approved and introducedin April 2019by ADMA 1. ADMA Biologics patents issued 9,107,906 – 9,714,283 – 9,815,886 2. ASCENIV Prescribing Information, ADMA Biologics, 2019 Plasma
pool is derived from a minimum of 1,000 unique donors and blends normal source plasma with RSV plasma Manufactured through a patented process using source plasma, which is acquired from donors screened using a microneutralization assay to
detect and identify which donors possess naturally occurring neutralizing antibody titers to respiratory syncytial virus (RSV) Plasma collected from U.S. FDA-licensed plasma collection centers Meets potency requirements for
21CFR640 ASCENIV: FDA-Approved Protection Against Serious Infections Proven Efficacy in Treating Patients with PI (2)
Nabi-HB® Overview THE THREAT OF HEPATITIS B NABI-HB PROVIDES PROTECTION AGAINST HEPATITIS B
INFECTION WITHIN 24 HOURS OF ADMINISTRATION (7) Anti-HBs = anti-hepatitis B surface antibodies; IU = international units; WHO = World Health Organization; HBIG = hepatitis immunoglobulin; HBV = hepatitis B virus; HIV=human immunodeficiency
virus. Highly protective potency with Nabi-HB (7)Each milliliter of Nabi-HB contains >312 IU/mL of anti-HBsThe potency of each milliliter of Nabi-HB exceeds the potency of anti-HBs in a U.S. reference hepatitis B immune globulinThe U.S.
reference has been tested against the WHO standard and found to be equal to 208 IU/mL Established brand and distribution channels driving increased utilization in PEP and sexual assault patients Successfully used for over 20 years to
protect against hepatitis B infection among newly exposed individuals (post-exposure prophylaxis PEP) Manufactured from plasma obtained from vaccinated donors with high titers of antibodies to hepatitis B surface antigen, anti-HBsReceived FDA
approval in March 1999 under Nabi Biopharma; recorded first commercial sale under ADMA in April 2018 Approved in March 1999(via Nabi); marketed by ADMA beginning in June 2017 Delivers highly effective protection (7)Nabi-HB is 75% effective
in preventing an HBV carrier state in those at risk following sexual exposure to persons with acute hepatitis BIf administered as a single dose within 2 weeks of exposure EFFICACY WHEN
ADMINISATERED AS A SINGLE DOSE WITHIN 2 WEEKS OF EXPOSURE 75% Effective CDC Recommendations for Prophylaxis: Administering an HBIG with the HBV vaccine series is highly effective in preventing transmission following exposure to HBV
(1) The HBV vaccine series alone takes up to 2 weeks to achieve initial serum levels and 3 doses (across 6 months) to provide seroprotection in ~90% of patients (1)(5)(6)Waning antibody levels may compromise seroprotection over
timeAmong immunocompetent HBV vaccine responders, protection lasts 15 to 20 years (1)~67% of U.S. adults 19-49 years old do not have adequate HBV vaccination coverage (1) HBV is 50-100x more infectious than HIV (1)The risk of blood-borne
infections being transmitted after a sexual assault is greater than with consensual sex (1)(2)Incidence of HBV exposure during sexual assault is unknown since the HBV status of perpetrators is rarely known (3)Once someone is exposed to HBV,
it may take hold and develop into potentially deadly chronic liver disease (4) Poses An Immediate Threat to Sexual Assault Patients Seroprotection Remains a Serious Issue Nabi-HB: FDA-Approved for Enhanced Immunity Against Hepatitis-B
Proven Efficacy in Treating Hepatitis B 1. Centers for Disease Control and Prevention.2. Middlesex-London Health Unit. Post exposure management: hepatitis B, hepatitis C and HIV3. Roberts and Hedges' Clinical Procedures in Emergency
Medicine and Acute Care4. World Health Organization5. Do patients who received only two doses of hepatitis B vaccine need a booster? Cleve Clin J Med. 20146. PDR: prescriber’s digital reference. Engerix (hepatitis B vaccine recombinant) drug
summary7. Data on file. ADMA Biologics
ADMA’s Patented Immunotechnology is Used to Manufacture ASCENIV™ PATENTS
ISSUED9,107,906 - Composition9,714,283 - Use9,815,886 - MethodsExpiration 2035 *These patents include the use of IG for treatment and prevention of all viral induced respiratory infections 18
Pipeline & Label Expansion Opportunities Published data suggests additional label expansion
opportunities may be explored for ASCENIV™ Potential additional target populations for ASCENIV™ As previously disclosed, we believe the published data and FDA approval of ASCENIV™ better positionsADMA to further its mission to evaluate
ASCENIV™ in immune-compromised patients infected with or at-risk for Respiratory Syncytial Virus (RSV) infection HSCT/Bone Marrow Transplant ~22,000 procedures/year performed in the USSolid Organ Transplant (lung, heart, liver and
multi-organ) ~14,000 solid organ transplants/year (excluding kidney transplants) performed in the USCancer Patients Receiving Chemotherapy ~650,000 patients/year receive chemotherapy in the USOthers At-Risk for RSV Infection
Commercialization/Distribution Strategyfor ADMA’s Immunoglobulins Identified and engaged
with appropriate channel partners that align with our call planand sites-of-service where there is demand across our immunoglobulin portfolio Distribution channel is well definedInpatients – hospital basedOutpatients – infusion center /
physician office / homecare Well established distribution organizations handle cold-chain products efficientlyHave existing product serialization tracking systemsHave existing relationships with hospital pharmacy buyers and infusion
center/homecare purchasing departments ADMA’s product portfolio offerings have overlapping prescriber call pointsClinical immunologistsInfectious diseasesHematology/oncologyCritical care & emergency medicine HOSPITALPHARMACY TIER ONE
INSTITUTIONS INDEPENDENTINFUSION CENTERSHOME CARE COMPANIESINDEPENDENT GPOs EMERGENCY MEDICINE INFECTIOUS DISEASE CLINICAL IMMUNOLOGY HEMATOLOGY/ONCOLOGY
Plasma Product Manufacturing Overview
Fractionation plants are scarce with only a few companies operating FDA-approved facilities in the
U.S. World-class, cGMP-compliant plasma fractionation facility and laboratories in Boca Raton, FL; acquired in June 2017 Recent FDA compliance inspection completed in August 2021 One of few FDA-approved fractionation facilities in the
U.S.Total staff: ~350Annual capacity of up to 600,000 liters, or ~2.4M grams of finished IG, supporting a $300M+ revenue opportunityYield of ~3.5-4 g / L and revenue / liter of $600-$800Patented immunotechnology to screen hyperimmune donors,
tailor plasma pool compositions and conduct proprietary antibody detection testingCapable of full product transfers as well as initial phase plasma product concept development In-house fill-finish capabilities following the 2021 FDA approval
of the VanRx machine Plasma Intermediates are harvested with each batch of IG produced (e.g., Cryoprecipitate and Fraction V). Potential for up to $20M annual revenue opportunity ADMA ManufacturingOne of Few Manufacturers of Specialty IGs in
the U.S.
Production of Plasma-Derived Therapies Approximately 4-6 months – includes all in-process bulk
testing and batch record reviewand release by ADMA and any 3rd parties Cohn-Oncley Cold Ethanol Fractionation Process (Estimated 7-12 Months) End-to-end control of the supply chain and production process to produce our productsand
leverage our expertise as a CMO for others Donors Plasmapheresis Source plasma for manufacturing Must include a 45 day hold per FDA regulation Raw MaterialCollections 1 Manufacturing Cryoprecipitate Viral inactivation
II+III Paste / IG / IVIG Fraction IV Fraction V Fractionation (upstream) Purification (downstream) Ultra-filtration Final formulation 2 Filling & Packaging Filling into vials Final packaging & labeling Lot #
serialization 3 Release & In-Process Testing ADMAin-house 3rd party labs FDA review of each lot 90 days for certain 3rd party lab release tests 4
Internal fill-finish production capabilities expected to result in: Product Labeling,
Packaging and Serialization New VanRx SA25 aseptic fill-finish machine received FDA approval In-house fill-finish capabilities with the 2021 FDA approval of the VanRx SA25 workcell In-house specialty team to oversee third-party
operationsPotential to improve final product yield and enhance margins, speed and time to release product to market Greater product supply consistency Significantly improved operational efficiencies Significantlyimproved gross
margins Contract Manufacturing Opportunities: Fill-Finish, Packaging and Serialization Reducedmanufacturing cycle times Fill-Finish Capabilities VanRx Machine Brings Fill-Finish Capabilities In-House
Plasma Collection Centers:
ADMA BioCenters Overview:Advancing Towards Plasma Self-Sufficiency Plasma collection centers are
essential to ensure raw material supply to produce IG and other plasma proteinsADMA BioCenters currently consists of a network of9 plasma collection centers in various stages of approval and developmentTotal staff: ~150First center opened in
2011; network now includes 6 fully operational BioCenters in Tennessee, South Carolinaand GeorgiaOn track to have 10+ FDA approved centers by 2023 to achieve substantial plasma supply self-sufficiencyADMA BioCenters collects hyperimmune and
normalsource plasmaIn addition to providing plasma supply for ADMA products, collected plasma is sold through supply contracts to leading plasma companies Plasma centers are essential to ensure raw material supply to produce IG and other
plasma proteins;Supply self-sufficiency forecasted to be achieved by 2023
Expanding the ADMA BioCenter Network - 2021 Forward Enhance economies of scale, speed to
market, self-reliance, and increase market share FDA-approved validation, SOPs, and training documentation in place Opening additional centers – low regulatory risk and rapid time to first collections due to current FDA approval of
documentation and methods Plan to have 10 or more collection centers in approved in various geographic locations across the US by 2023 Vertical integration provides ADMA with increased speed to ramp to peak collection volumes in
FDA-approved biologics manufacturing plants Use what we need, sell what we don’t – decrease COGS, and generate additional revenue Goals Realize forecasted economies of scale as collections increase reducing the overall cost per L Enhance
efficiencies and ensure self-sufficiency into the future Growth of the ADMA plasma collection network to firm up the ability to ramp IG production and grow market share
Milestones, Corporate and Financial Highlights
Experienced Management Team and Board of Directors NAME SELECTED CURRENT OR PAST
AFFILIATIONS Adam GrossmanFounder, President, CEO & Director Brian Lenz, CPAExecutive Vice President, Chief Financial Officer Dr. Jerrold GrossmanFounder & Vice Chairman Lawrence GuiheenDirector Martha DemskiDirector Bryant
FongDirector Steven ElmsChairman Young Kwon, Ph.D.Director
Financials Current Financial Overview Nine Months Ended September 30, 2021 Nine Months Ended
September 30, 2020 Revenues $54.6M $28.3M Net Loss $(55.0M) $(56.3M) Loss per common share $(0.44) $(0.68) Cash and cash equivalents $34.4M $59.7M Total assets $238.7M $190.0M Total liabilities $135.9M $118.6M Total
stockholders' equity $102.8M $71.4M Common stock outstanding 195.8M 94.5M Fully diluted common stock outstanding 212.6M 103.9M Cash Balance Excludes Gross Proceeds of $57.5M From Equity Financing Completed October 2021
Upcoming Milestones OBJECTIVES Execute on supply chain robustness for increased BIVIGAM® plasma
pool scale Execute on supply chain robustness for aseptic fill/finish machine Expand our BioCenters plasma collection facility network to a total of 10 or more Expand commercial production and penetration of our marketed IVIG product
portfolio Disclose potential product development pipeline consisting of additional specialty plasma and/or hyperimmune IG products
ADMA Investment Highlights Unique and Different Supply-Chain Nuances and Regulatory
Requirements Long production cycle-time – it can take 7 to 12 months for the end-to-end production, fill/finish, testing and release of a batch of IG Large inventories required for raw material and in-process product are needed to ensure
consistent and routine supply Raw material US source plasma is in high demand globally with commodity-like pricing To market plasma products for the US, products must be made from US donor plasma in FDA-approved biologics manufacturing
plants Regulatory Barriers – Strict rules and regulations from FDA and State health departments; FDA performs release testing for each batch of ADMA’s IG products Working capital requirements are substantial due to product production cycle
and sales receivable cycle Commercial Sales & Production Ramp Underway ADMA manufactures and markets 3 FDA-approved IG products in the US:BIVIGAM® relaunched and marketed in 2019ASCENIV™ first commercial sales in 2019NABI-HB® marketed
in the US since 1999 Potential peak revenues of all ADMA’s IG products and production processes to reach >$300M as we ramp production ADMA controls all aspects of manufacturing, regulatory affairs and quality assurance Opportunities to
expand production capacity, increase production yield and revenue while enhancing margins Patent portfolio across hyperimmune IG landscape including the production of ASCENIV™ ADMA Biologics has existing infrastructure and processes in
place to manageplasma-derived products distinctive requirements 32
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