Adma Biologics Inc · NASDAQ:ADMA
Adma Biologics — Investor Presentation (December 2021)
33 slides from Adma Biologics's investor presentation, Dec 1, 2021
Slide 1: Realizing the Potential of Plasma-Derived Therapies with Groundbreaking Immunotechnology
ADMA Biologics Realizing the Potential of Plasma-Derived Therapieswith Groundbreaking Immunotechnology December 2021 NASDAQ: ADMA
Slide 2: Forward-Looking Statements
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 limitat
Slide 3: Who We Are
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 devoti
Slide 4: ADMA Investment Highlights
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 Throu
Slide 5: Differentiated Opportunity in a Large & Growing Market
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 ma
Slide 6: Vertically Integrated with Leading Technology, Supply Chain & Production Processes
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 Y
Slide 7: Well-Defined and De-Risked Pathway to Profitability & Unique Scarcity Value
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 producti
Slide 8: Potential Upside Through Operating Leverage & New Product Pipeline Opportunities
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
Slide 9: ADMA Offers a Multi-Faceted Revenue-Generation Platform
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 s
Slide 10: Plasma Products Portfolio Commercial Opportunities
PLASMA PRODUCTS PORTFOLIO COMMERCIAL Opportunities:
Slide 11: Introduction to Plasma-Derived Therapies and Immunoglobulins (IG)
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
Slide 12: Plasma IG Market Is Sizeable & Growing
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 awar
Slide 13: Despite Decades of IG Use, Improved Therapies Still Needed
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 l
Slide 14: IG is Widely Used and Reimbursed Across Payer Mix
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 syndromeCh
Slide 15: BIVIGAM Overview
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
Slide 16: ASCENIV Overview
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,
Slide 17: Nabi-HB Overview
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 vi
Slide 18: ADMA's Patented Immunotechnology is Used to Manufacture ASCENIV
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
Slide 19: Pipeline & Label Expansion Opportunities
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 furt
Slide 20: Commercialization/Distribution Strategy for ADMA's Immunoglobulins
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 basedOutpat
Slide 21: Plasma Product Manufacturing Overview
Plasma Product Manufacturing Overview
Slide 22: Fractionation plants are scarce with only a few companies operating FDA-approved facilities
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-approve
Slide 23: Production of Plasma-Derived Therapies
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 t
Slide 24: Internal fill-finish production capabilities
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 overse
Slide 25: Plasma Collection Centers: A2MA
Plasma Collection Centers: A2MA
Slide 26: ADMA BioCenters Overview: Advancing Towards Plasma Self-Sufficiency
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 developmentT
Slide 27: Expanding the ADMA BioCenter Network - 2021 Forward
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 cur
Slide 28: Milestones, Corporate and Financial Highlights
Milestones, Corporate and Financial Highlights
Slide 29: Experienced Management Team and Board of Directors
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 Br
Slide 30: Current Financial Overview
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.
Slide 31: Upcoming Milestones
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
Slide 32: ADMA Investment Highlights
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
Slide 33: Thank You
ARMA Thank You
ADMA Biologics — Investor Presentation (December 2021) on 6ix