EX-99.1 2 ef20041449_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1
ADMA Biologics Realizing the Potential of Specialty Biologicswith Groundbreaking Immunotechnology January 2025 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 ability to manufacture ASCENIV and BIVIGAM on a commercial scale and further commercialize these products as a result of their approval by the U.S. Food and Drug Administration (the “FDA”) in 2019; 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 (including SG-001) and estimated revenue potential for such product candidates; 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, suppliers and vendors and their compliance with applicable regulatory requirements; our ability to obtain adequate quantities of 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; the potential production yield enhancement and potential benefits, if approved; 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; our ability to ensure continuity of product supply; our estimates regarding EBITDA and Adjusted EBITDA; 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 and the defense thereof, including our expectations regarding the scope of patent protection with respect to our products or other future pipeline product candidates; the achievement of or expected timing of clinical and regulatory milestones; our manufacturing capabilities; third-party contractor capabilities and strategy; our manufacturing, supply and other collaborative agreements; potential contract manufacturing opportunities and sales of our immune globulin products; 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 of our existing products as well as our expectations of market acceptance of BIVIGAM® and ASCENIV™; and future domestic and global economic conditions and performance. 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, and the labeling or nature of any such approval, as well as our third-party Respiratory Syncytial Virus plasma agreements and their potential impact on our financial performance; 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 relating to 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 NASDAQ: ADMA

Who We Are: An Innovative Specialty Biologics Company ADMA Biologics ian 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 4 ADMA Biologics is an end-to-end, vertically integrated biopharma company leading the wayas a producer of specialty biologics Three FDA-approved products: 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 Providing for commercial durability through the mid/late 2030s and additional R&D pipeline opportunities Contract manufacturing: Full suite of CDMO and contract manufacturing capabilities (CMO). Partnering clinical-stage or commercial aseptic filling, packaging, (GMP) testing requirements Optimized manufacturingprocesses: Robust, sustainable, and controlled manufacturing process for producing our commercially available specialty biologics 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 Long-term, third-party supply contracts in place supporting revenue growth Corporate HeadquartersRamsey, NJ Manufacturing CampusBoca Raton, FL ~700 Full Time Employees ADMA BioCentersHeadquarters, Roswell, GA

Vertically Integrated U.S.-Based Manufacturing Supply Chain with Innovative Technology Unique visibility of ~9-12+ months out given end-to-end production cycle ADMA’s end-to-end manufacturing capabilities enable efficiency, visibility and a competitive advantage MANUFACTURING & PRODUCTION World-class facility for fractionation & purification of IGs VIRAL INACTIVATION ULTRA-FILTRATION FINAL FORMULATION CRYOPRECIPITATE II+III PASTE / IG / IVIG FRACTION IV FRACTION V PLASMA COLLECTION ADMA BioCenters & long-term supply contracts provide stable source of plasma SOURCE PLASMA FOR MANUFACTURING DONORS PLASMAPHERESIS FDA REGS -60 DAY-HOLD FILLING INTO VIALS FINAL PACKAGING & LABELING LOT # SERIALIZATION 90 DAYS FOR CERTAIN 3RD PARTY LAB RELEASE TESTS ADMA IN-HOUSE 3RD PARTY LABS FDA REVIEW OF EACH LOT RELEASE &IN-PROCESS TESTING FILLING & PACKAGING In-house fill-finish capabilities following the approval of the VanRx SA25 workcell Well-positioned infrastructure to support near and long-term revenue growth and ensure continuityof product supply into a supply-constrained U.S. immunoglobulin (IG) market Vertically integrated and fully U.S.-based manufacturing supply chain Among an elite group of U.S.-based biologic drug manufacturers End-to-end controlof supply chain In-HouseFill-Finish Comprehensive in-housecontrol of critical manufacturingand testing functions End-to-end control of supply chain from plasma collection through plasma fractionation, purification, fill-finish,testing and distribution 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 Up to 600,000L (or ~2.4M grams of IG) annual plasma processing capacity QC / Scientific Lab performs small-scale process development, assay development and validation and testing of raw materials

Vertical Integration: Plasma Collection Centers are Essentialto Ensure Raw Material Supply to Produce IG 10 FDA-Approved BioCenters in Maryland, Tennessee, Louisiana, North Carolina, South Carolina and Georgia ADMA BioCenters collects hyperimmune & normal source plasma – allows for internal control of new R&D product opportunities ADMA BioCenters Collection Network Recently Executed 3rd Party Supply Contracts Internal plasma collection capabilities coupled with 3rd party supply contracts support near and long-term revenuegrowth objectives Internal & 3rd party supply visibility support all go-forward revenue growth targets New 3rd party supply contracts successfully executed:agreements solidify high titer plasma supply through late 2030s and eliminate ASCENIV’s historic growth bottleneck ADMA can now source high-titer plasma from ~250 3rd party collection centers Supply availability supports ~$1bn potential annual revenue opportunity prior to 2030, with significant growth opportunities anticipated thereafter ADMA’s proprietary screening assay provides for accelerated 3rd party plasma screening in-house Plasma collection centers are essential to ensure raw material supply to produce IG ~$1bn annual revenue opportunityprior to 2030

US IG Landscape NASDAQ: ADMA

Fast Growing & Highest Margin Company in a Large and Expanding IG Market Source: (1) Source: Marketing Research Bureau, 2023 U.S. Fractionation Market Report, ADMA internal analysis (2) Centers for Disease Control, National Institute of Health In a 40-year study of 473 patients with PI on standard IVIG3,4 Despite Decades of IG use, ImprovedTherapies Still Needed High Market Demand & Opportunity in The US IG Market1 Whitespace for ADMA’s Innovative IG Products Within the Broader Market1 Pi is a Significant Market Opportunity2 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 antibodiesor a failure of these antibodies to function properly Estimated prevalence of 1:1,200 in the U.S., or approximately 250,000 people(2) NIH estimates 500,000 undiagnosed PI patientsin the U.S. Over 450 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 70%1Of immunoglobulin brands requireprior authorization & prescribers arefamiliar with approval process (3) The broad spectrum of lung diseases in primary antibody deficiencies. Eur Respir Rev. 2018. (4) Morbidity and mortality in common variable immune deficiency over 4 decades. ‘15-23CAGR 12% ‘23-30CAGR 7% 2015 2023 2030 ADMA2% Large Potential & Whitespace BPL / Kedrion5% Octapharma14% Grifols22% CSL25% Takeda32% ASCENIV AND BIVIGAM ARE BOTH INDICATED FOR THE TREATMENT OF PI Developedbronchiectasis6 Experienced recurrentrespiratory tract infection5 Developed chroniclung disease6 Significant unmet need exists in PI patientsrefractory to standard IG that continue toexperience recurrent respiratory infectionand chronic lung disease (5) The lung in primary immunodeficiencies: New concepts in infection and inflammation. Front Immunol. 2018. (6) . Subclinical infection and dosing in primary immunodeficiencies. Clin Exp Immunol. 2014.

ASCENIVTM – ADMA’s Unique IG Offering THE PRODUCTION OF ASCENIV ONLY IG 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. Compelling real-world evidence is driving ASCENIV growth in the complex PI patient population Indicated for the treatment of patients with primary immunodeficiency (PI) ADMA has successfully defined appropriate use for ASCENIV by characterizing complex PI patient risk-profiles ADMA has positioned ASCENIV as a later-line therapy ASCENIV real world outcomes are driving favorable payer coverage in appropriate PI patients 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) One patient from the study group was hospitalized because of a postoperative local wound infection from elective surgery 24 out of 59 patients (41%) had a total of 54 unscheduled medical visits due to infections 23 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%) 37 patients (63%) used antibiotics due to infection (includes therapeutic use) hospitalizations due to infection missed days of work/school/activity PPPY due to infection unscheduled medical visits PPPY days of antibiotic use PPPY Patients and physicians can count on ASCENIV to reduce infection-related quality-of-life impact

ASCENIVTM – Making a Positive Difference for Patients with PI We do what we do because patients are counting on us 1. ADMA Biologics patents issued 9,107,906 – 9,714,283 – 9,815,886 2. ASCENIV Prescribing Information, ADMA Biologics, 2019 Compelling Real-World Patient Testimonials Testimonial Highlight: Kyler’s Story “I'm so grateful that I have ASCENIV in my corner” MEET LISA MARIE, 55-year-old nurse, married with a blended family of 5 children, living with a rare blood vessel disease in addition to PI “Before ASCENIV, I kind of just existed” MEET REGINA, 50-year-old elementary math tutor, married with 3 children, one of whom also has PI “With ASCENIV, I’m looking forward to just being a kid” MEET KYLER, 17-year-old student, passionate about sports photography and an enthusiastic lacrosse player “Thanks to ASCENIV, I got my life back” MEET LYNNE, 65-year-old caregiver, married with 2 children, who works with people who have developmental disabilities “Thanks to ASCENIV, the old me is coming back“ MEET SHERRY, 51-year-old nurse, married with a daughterin college “With ASCENIV, I’m looking forward to just being a kid” MEET KYLER, 17-year-old student, passionate about sports photography and an enthusiastic lacrosse player MY STORY I was diagnosed with PI as a baby and hospitalized very often with recurrent infections. Growing up, I missed a lot of school because I was sick all the time and had to stay home. I wasn’t able to hang out with friends or play sports like other kids my age. It felt like I had to stop doing everything. MY PI DIAGNOSIS While I was on other immunoglobulin treatments for PI, I was still getting infections. I was still sick almost every day to the point where we were going to doctors twice a week to try to figure out what was going on. I was spiraling; I went from a multi-sport athlete to a full-time patient. I switched to ASCENIV when I got to a point where nothing else was working. MY EXPERIENCE WITH ASCENIV Since starting ASCENIV, I am back to playing all my favorite sports again. For the first time, I can attend lacrosse practice with my team after a full school day; I used to have trouble just getting through classes. It really changed my outlook for the future.

(TAM): Total Adressable Market ~10% (25k patients) 250,000+ Diagnosed PI Patients & Growing High Demand & Growth Opportunity for ASCENIV Within the Broader IG Market Patients with recurrent, breakthroughinfections on standard IG therapy cycle through multiple lines of products A sub-set of PI patients suffer from complex co-morbidities Uncontrolled patients are regularly unable to conduct daily activities Frequent doctor office visits and hospitalizations Clinicians and patients need an additional therapeutic intervention with a tailored composition for underserved high-risk immunodeficient patients Significant upside potential with incremental penetration into the complex PI patient TAM (1) Source: ADMA Company Estimates High Demand for ASCENIVin a Sizable, Refractive TAM Market Penetration Total Prevalence: NIH Estimates 500k Diagnosed and Undiagnosed PI Patients in the U.S. Levels of severity and risk differ across the PI population Clinicians and patients need an alternative therapeutic intervention for underserved high-risk immunodeficient patients To date ADMA has penetrated ~3% ofits 25,000 patient TAM(1)

Established distribution network and channel partners comprehensively cover targeted call-points and sites of care Distribution channel is well defined Inpatients – hospital based Outpatients – infusion center / physician office / homecare Established distribution partners handle cold-chain products efficiently Have existing product serialization tracking systems ADMA’s product portfolio offerings have overlapping prescriber call points Clinical immunologists Infectious diseases Critical care & emergency medicine HOSPITALPHARMACY TIER ONEINSTITUTIONS Independent infusion centers Home care companies Independent GPOs EMERGENCY MEDICINE INFECTIOUS DISEASE CLINICAL IMMUNOLOGY HEMATOLOGY/ONCOLOGY ADMA’s Innovative Commercial Model Commercial Infrastructure in Place to Support Growth ADMA has comprehensive engagement among the ~300-400 specialists that serve the target patient population including key opinion leaders ~35-person commercial team(1) Call points & end-markets are consolidated and uniquelynon-promotionally sensitive Significant Opportunities for Value Creation Significant, identified growth opportunities by way of both increased depth & expanded breadth of prescriber coverage Commercial organization is scaled & able to carry additional products (1) FTEs in commercial segment including MSLs and field personnel

Upside & Growth Opportunities NASDAQ: ADMA

Regulatory filing successfully submitted to the FDA; potential mid-2025 approval Demonstrated ability at the commercial production scale to potentially realize ~20% additional IG production yields from same quantities of starting plasma Significant upside potential from production yield enhancement, if approved Outsized EBITDA contribution margins on incremental sales from enhanced yield finished goods, if approved Production Yield Enhancement: Significant Upside Potential Transformative increases to revenue and earnings growth outlooks with the potential approval of ADMA’s innovative yield enhancement process Yield Enhancement FDA submissioncomplete; potentialmid-2025 approval ~20% additional IG production yields from same quantities of starting plasma Significant upside potential from production yield enhancement Outsized EBITDAcontributionmargins on incrementalsale, if approved ADMA’s nimble manufacturing footprint allows for rapid implementation

SG-001: Potential Upside Through New Product Pipeline Program Issued IP for commercial product to screen hyperimmunedonors, tailor compositions and form plasma pools. IP protectionthrough 2035 Attractive new product and label expansion opportunities for specialty IGs targeting patient populations with high unmet need SG-001, our lead hyperimmune pipeline program targeting S. pneumoniae infections is covered by a patent estate extending into 2037 Issued IP provides for the exploration of additional hyperimmune globulins with potential utility across a range of respiratory infectious diseases Potential Hyperimmune Globulin Pipeline Expansion ADMA’s Patented Immunotechnology 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 New Product Pipeline & Label Expansion Lead Pipeline Program: SG-001, S. pneumonia IG ASCENIV Pediatric Capital Efficient R&D Engine Supporting New Product Opportunities Attractive new product and label expansion opportunities for specialty IGs targeting patient populations with high unmet needs Conducting an R&D program involving development of a S. pneumoniae hyperimmune globulin Issued S. pneumoniae IP provides branded exclusivity through 2037+ Leading cause of community-acquired pneumonia in the U.S., with ~1M adults developing pneumococcal pneumonia annually 400,000 hospitalizations and a5-7% mortality rate $300-500mm Annual revenue potential All pediatric patients successfully completed PMC study and the clinical trial database has been locked sBLA to be submitted over the coming quarters – label expanding FDA-Approval potentially in the first half of 2026 Opportunity to further strengthen ADMA’s commercial product offering

Senior Leadership NASDAQ: ADMA

Experienced Management Team and Board of Directors NAME SELECTED CURRENT OR PAST AFFILIATIONS Dr. Jerrold GrossmanFounder & Vice Chairman Lawrence GuiheenDirector Steven ElmsChairman Young Kwon, Ph.D.Director Alison FingerDirector Kaitlin KestenbergCOO & SVP Compliance Brad TadeCFO & Treasurer Adam GrossmanFounder, President, CEO & Director Eduardo Rene SalasDirector

Financials NASDAQ: ADMA

Rapidly growing revenue and earnings growth, with uniquely durable asset base $1B+ annual revenue opportunityprior to 2030 2025 forecasted Adjusted EBITDA margins of ~45% Significant ongoing margin expansion anticipated to 2030 and thereafter ~45% adj. EBITDA Margin ~50% adj. EBITDA Margin Revenue Adj. EBITDA Net Income 2025 Guidance 2026 Guidance Forecasted Financial Guidance Annual Revenue Potential Prior to 2030 Rapid Revenue and Earnings Growth Trajectory HIGHLIGHTS Significant revenue and earnings growth outlook

Financial Overview Financial Overview Three Months Ended September 30, 2024 Three Months Ended September 30, 2023 Revenues $119.8M $67.3M Gross Profit $59.7M $24.7M Adjusted EBITDA(1) $45.4M $12.7M Net Income $35.9M $2.6M Cash and cash equivalents $86.7M $74.2M Total assets $390.6M $349.0M Total liabilities $158.7M $197.6M Total stockholders' equity $231.9M $151.4M Weighted Avg. Diluted Common Shares Outstanding 244.8M 233.8M (1) Adjusted EBITDA is a non-GAAP financial measure. For a reconciliation of Adjusted EBITDA to the most comparable GAAP measure, please see the Company’s earnings releases and SEC filings, as well as a reconciliation in the appendix Preliminary Unaudited Est. Total Revenue For FY 2024 Total Cash on Hand YE 2024 ~$425M $100M+

Appendix - Non-GAAP Reconciliation (1) Adjusted EBITDA is a non-GAAP financial measure. For a reconciliation of Adjusted EBITDA to the most comparable GAAP measure, please see the Company’s earnings releases and SEC filings, as well as a reconciliation in the appendix (In US Millions) 3Q24 2Q24 1Q24 4Q23 3Q23 2Q23 1Q23 GAAP Net Income (Loss) $35.90 $32.10 $17.80 ($17.60) $2.60 ($6.40) ($6.80) Loss on extinguishment of debt $26.20 IT systems disruption $2.80 Adjusted Net Income (Loss) $35.90 $32.10 $17.80 $8.50 $2.60 ($3.60) ($6.80) Depreciation $1.90 $1.90 $1.90 $1.90 $1.90 $1.90 $1.90 Amortization $0.00 $0.10 $0.20 $0.20 $0.20 $0.20 $0.20 Income Taxes $0.80 $3.80 $0.60 $0.00 $0.00 $0.00 $0.00 Interest expense (Income) $3.50 $3.80 $3.80 $6.20 $6.40 $6.30 $6.10 EBITDA $42.20 $41.70 $24.30 ($9.30) $11.10 $2.00 $1.40 Stock-based compensation $3.20 $2.90 $2.10 $1.70 $1.70 $1.60 $1.10 IT systems disruption $2.80 Loss on extinguishment of debt $26.20 Adjusted EBITDA(1) $45.40 $44.50 $26.40 $18.60 $12.70 $6.40 $2.50

ADMA Investment Highlights Source: (1) Source: ADMA Company Estimates; Refractive; comorbid immunocompromised PI patients. SMART: Structural Demand, Manufacturing Optimizations, Advanced Tech, Raw Material Supply, Top-Tier Growth Outlook Top-tier revenue and earnings growth, unique asset durability, vertically integratedbiopharma company driving innovation in the specialty biologics market Clear Path to $1bn+ Ann. Revenue Opp. Prior to 2030 & Top Tier Earnings Growth Outlook Underpinned by drivers with realistic & highly achievable assumptions. Significant ongoing margin expansion to 2030 and thereafter Optimized cGMP Robust, sustainable, and controlledmanufacturing process Integrated Collection & Production State-of-the-art production capabilities and long-term raw material plasma supply to reach revenue potential Structural Demand in Large IG Market Significant whitespace in ADMA’s TAM comprised of severe immune compromised PI patient population(1) Highly Durable & Significant Longevity Strong IP, significant natural barriers (reg., production timelines, capital investments) & no known generic/biosimilar risks provide for durability into late 2030’s & beyond