Company Overview - ADMA Biologics is a specialty producer of unique plasma-derived biologic products, primarily focusing on IVIG products that extract antibodies from human plasma [3] - The company has three FDA-approved commercial products and has preannounced total revenue of over $510 million for its commercial organization [3] Financial Performance - For the fourth quarter, ADMA expects revenue to exceed $139 million, with EBITDA projected at $77 million to $78 million or more, and net income anticipated to be around $50 million or more [3] - This financial performance represents a substantial increase compared to the third quarter of 2025 [3] Intellectual Property - The company holds intellectual property that protects its lead product ASCENIV until June 2035, focusing on the testing and identification processes [4]

ADMA Biologics Realizing the Potential of Specialty Biologics with Groundbreaking Immunotechnology January 2026 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, performan ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $134.2 million, reflecting a 10% increase quarter-over-quarter and a 12% increase year-over-year [5][11] - GAAP net income reached $36.4 million, up 6% quarter-over-quarter and 1% year-over-year [5][11] - Adjusted EBITDA grew to $58.7 million, representing a 16% quarter-over-quarter increase and a 29% year-over-year increase [5][11] Business Line Data and Key Metrics Changes - ASCENIV, the company's specialty immunoglobulin product, showed record utilization driven by strong prescriber adoption and sustained patient demand [6][10] - Product-level gross margins reached 63.7% during Q3 2025, excluding a plasma sale of $13.8 million [11][12] - The company completed a sale of approximately $13.8 million of normal-source plasma at a negative margin contribution to optimize working capital [13] Market Data and Key Metrics Changes - The company anticipates improved ASCENIV reimbursement access beginning in 2026, with payer negotiations progressing positively [6][10] - A retrospective cohort analysis showed a significant reduction in infection rates for patients switching from standard IG therapy to ASCENIV, with a reduction of over 50% [7][26] Company Strategy and Development Direction - The company aims to expand ASCENIV access and utilization, scale yield-enhanced production, and drive continued margin expansion [10][19] - The SG-001 program is progressing, with potential to address significant unmet medical needs and expected to contribute to long-term revenue growth [9][19] - The company maintains a disciplined capital allocation strategy, focusing on stockholder value through share repurchases and reinvestment in growth initiatives [10][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over $1.1 billion in annual revenue by 2029, supported by yield-enhancement efficiencies and expanding ASCENIV demand [14][15] - The company expects continued strong double-digit revenue growth into 2026, driven by improved payer access and increased utilization of ASCENIV [17][31] Other Important Information - The company maintains a strong balance sheet with an undrawn $225 million revolving credit facility, providing flexibility for growth initiatives [10][14] - The FDA's release of yield-enhanced production batches is expected to improve gross margins starting in Q4 2025 [8][52] Q&A Session Summary Question: Can you provide details on the publication of ASCENIV data? - Management confirmed plans for a peer-reviewed publication in early 2026, highlighting significant infection reduction data [24][26] Question: What is the expected impact of ASCENIV data on demand? - Management anticipates that the data will reinforce prescriber confidence and potentially lead to earlier use of ASCENIV in treatment cycles [29][31] Question: What factors contributed to raising revenue guidance? - Management cited record product pull-through and increased availability of ASCENIV as key factors for confidence in raised guidance [35][36] Question: Are there any gating factors for yield-enhanced product impact in Q4? - Management indicated that yield-enhanced products will flow through product sales in Q4 without significant gating factors [41] Question: How will gross margins expand in the coming quarters? - Management expects gross margins to potentially exceed 70% in 2026 due to ongoing yield enhancements and product mix shifts [52] Question: What is the status of payer negotiations for ASCENIV? - Management reported positive negotiations with payers, with expectations for improved access and reduced restrictions in 2026 [54][58] Question: How many physicians or centers are currently using ASCENIV? - Management noted that there are over 100 prescribing physicians, with a target of reaching around 300 to support revenue goals [60][62] Question: Can the hit rate for plasma collections improve over time? - Management expressed optimism that the amount of high-titer plasma collected will grow, supported by strong relationships with third-party suppliers [68]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $134.2 million, reflecting a 10% increase quarter-over-quarter and a 12% increase year-over-year [5][11] - GAAP net income reached $36.4 million, up 6% quarter-over-quarter and 1% year-over-year [5][11] - Adjusted EBITDA grew to $58.7 million, representing a 16% quarter-over-quarter increase and a 29% year-over-year increase [5][11] Business Line Data and Key Metrics Changes - ASCENIV, the company's specialty immunoglobulin product, showed record utilization driven by strong prescriber adoption and sustained patient demand [6][10] - Product-level gross margins reached 63.7% during Q3 2025, excluding a plasma sale of $13.8 million, compared to 49.8% last year [11][12] Market Data and Key Metrics Changes - The company anticipates improved ASCENIV reimbursement access beginning in 2026, with payer negotiations progressing positively [6][10] - A retrospective cohort analysis indicated a significant reduction in infection rates for patients switching from standard IG therapy to ASCENIV, with a reduction of over 50% [7][26] Company Strategy and Development Direction - The company aims to expand ASCENIV access and utilization, scale yield-enhanced production, and drive continued margin expansion [10][19] - The SG001 program is progressing, with potential to address significant unmet medical needs and expected to contribute to long-term revenue growth [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over $1.1 billion in annual revenue by 2029, supported by yield-enhancement efficiencies and expanding ASCENIV demand [14][15] - The company is optimistic about the future, citing a strong balance sheet and disciplined capital allocation strategy [19][10] Other Important Information - The FDA's release of yield-enhanced production batches is expected to improve gross margins starting in Q4 2025 [8][11] - The company maintains an undrawn $225 million revolving credit facility, providing flexibility for growth initiatives [10][14] Q&A Session Summary Question: Can you provide details on the publication of ASCENIV data? - Management confirmed plans for a peer-reviewed publication early in 2026, highlighting significant infection rate reductions with ASCENIV compared to standard IG therapy [24][26] Question: What is the expected growth curve for ASCENIV demand? - Management anticipates strong double-digit growth for ASCENIV, supported by ongoing data publication and payer negotiations [29][31] Question: What factors contributed to raising revenue guidance for 2026? - Confidence in revenue guidance was based on record product pull-through and increased availability of ASCENIV [35][40] Question: How will the FDA lot release impact gross margins? - Management expects gross margins to expand significantly in Q4 2025 and into 2026, potentially exceeding 70% [52][51] Question: What is the status of payer negotiations for ASCENIV? - Ongoing positive negotiations with payers are expected to improve access without significantly impacting gross margins [54][56] Question: How many physicians or centers are currently using ASCENIV? - Approximately 100 physicians are currently prescribing ASCENIV, with expectations for significant growth in the number of prescribers [59][61]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $134.2 million, reflecting a 10% increase quarter-over-quarter and a 12% increase year-over-year [6][12] - GAAP net income reached $36.4 million, up 6% quarter-over-quarter and 1% year-over-year [6][12] - Adjusted EBITDA grew to $58.7 million, representing a 16% quarter-over-quarter increase and a 29% year-over-year increase [6][12] - Gross margins expanded to approximately 56.3%, compared to 49.8% in the previous year [12] Business Line Data and Key Metrics Changes - ASCENIV, the company's specialty immunoglobulin product, showed record utilization driven by strong prescriber adoption and sustained patient demand [6][9] - Product-level gross margins reached 63.7% during Q3 2025, excluding a plasma sale of $13.8 million [12][13] Market Data and Key Metrics Changes - The company anticipates improved ASCENIV reimbursement access beginning in 2026 for select payers where restrictions previously existed [7] - A retrospective cohort analysis showed a statistically significant reduction in infection rates for patients transitioning from standard immune globulin therapy to ASCENIV, with a reduction of over 50% [7][26] Company Strategy and Development Direction - The company aims to expand ASCENIV access and utilization, scale yield-enhanced production, and drive continued margin expansion [11][18] - The SG001 program is progressing, with potential to address significant unmet medical needs and represent a $300-$500 million annual revenue opportunity [10][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over $1.1 billion in annual revenue by 2029, supported by yield-enhancement efficiencies and expanding ASCENIV demand [14][15] - The company maintains a strong balance sheet with an undrawn $225 million revolving credit facility, providing flexibility for growth [11][15] Other Important Information - The FDA's release of yield-enhanced production batches is expected to improve per-batch output by 20% or more, driving sustained gross margin expansion [9][12] - The company is actively negotiating with payers to improve access and is seeing positive trends in payer negotiations [56] Q&A Session Summary Question: Can you provide details on the publication of ASCENIV data? - Management confirmed plans for a peer-reviewed publication early in 2026, highlighting significant reductions in infections for patients switching to ASCENIV [26][27] Question: What is the expected growth curve for ASCENIV demand? - Management expects strong double-digit growth, supported by ongoing data publication and payer negotiations [31][32] Question: What factors contributed to raising revenue guidance? - Confidence stems from record product pull-through and increased availability of ASCENIV, leading to robust acceleration in growth [36][38] Question: How will the FDA lot release impact gross margins? - Management anticipates continued gross margin expansion, potentially exceeding 70% as yield-enhanced products flow through [52][53] Question: What is the status of payer negotiations? - Active discussions are ongoing, with positive trends in approvals and movement from restricted lists expected in early 2026 [56][57] Question: How many physicians or centers are currently using ASCENIV? - Approximately 300 clinical immunologists are targeted, with over 100 currently prescribing ASCENIV [60][61]

Core Insights - Palisades Investment Partners has completely exited its position in ADMA Biologics, selling 398,647 shares for approximately $7.3 million, indicating a strategic shift in investment focus [1][2][7] Company Overview - ADMA Biologics is a biopharmaceutical company specializing in plasma-derived therapeutics aimed at treating immune deficiencies and infectious diseases [6][9] - The company reported a total revenue of $474.2 million and a net income of $208.9 million for the trailing twelve months (TTM) [4] Financial Performance - ADMA Biologics experienced a year-over-year revenue growth of 14%, reaching $122 million, alongside a 7% increase in GAAP net income [8] - The stock price of ADMA Biologics closed at $15.48, reflecting a 5% decline over the past year, which is significantly lower than the S&P 500's 19% gain during the same period [3][4] Investment Strategy - Palisades' exit from ADMA Biologics highlights its adherence to a small-cap momentum strategy, where investments are sold when financial or operational momentum appears to stall [7][10] - The fund's decision to liquidate its position, despite ADMA's revenue and earnings growth, suggests a cautious outlook on the stock's future appreciation potential [10]

Core Insights - Adma Biologics reported Q2 2025 earnings with total GAAP revenue of $122.0 million, exceeding analyst expectations, and a GAAP EPS of $0.14, reflecting a year-over-year growth of 7.7% [1][2][5] Financial Performance - Revenue increased by 14.0% year-over-year from $107.2 million in Q2 2024 to $122.0 million in Q2 2025, driven by strong demand for ASCENIV® [2][5] - Adjusted EBITDA reached $50.8 million, marking a 14.2% increase from Q2 2024, while adjusted net income rose to $36.0 million, up 12.3% from $32.1 million [2][7] - Gross margin improved to 55.1%, up from 53.6% in Q2 2024, attributed to higher-margin immunoglobulin sales and operational efficiencies [2][6] Operational Developments - The company initiated commercial yield enhancement in manufacturing, with early production runs showing over a 20% increase in finished IG output, which is expected to significantly impact future revenue and profit [6][10] - Strategic investments included acquiring additional manufacturing space to expand capacity by up to 30% and completing a $300 million debt refinancing to lower borrowing costs [8][10] Product and Pipeline Insights - ASCENIV and BIVIGAM therapies continued to see robust demand, with ASCENIV utilization reaching new highs [9] - The development of SG-001, a candidate hyperimmune globulin for pneumococcal infections, showed promising results in animal studies, with potential peak annual revenue estimated between $300 million and $500 million [9] Future Outlook - Management reaffirmed revenue guidance of over $500 million for fiscal 2025 and more than $625 million for 2026, with total annual revenue expected to exceed $1.1 billion before 2030 [10] - The current guidance does not fully account for the impact of the FDA-approved yield enhancement or new pipeline products, indicating further growth potential [10][11]

Core Insights - ADMA Biologics is a fully integrated biopharmaceutical company focused on obtaining approvals for its products BIVIGAM and ASCENIV [1] Group 1 - The company has been under coverage since December 2018, highlighting its impressive profile and efforts in the biopharmaceutical sector [1] - The leader of the investing group Compounding Healthcare emphasizes the importance of innovative companies developing breakthrough therapies and pharmaceuticals [1]

Financial Data and Key Metrics Changes - Total revenues for 2024 reached $426.5 million, reflecting a 65% year-over-year increase [9][26] - Adjusted EBITDA grew to $164.6 million, representing a 309% increase from the previous year [10][29] - GAAP net income for Q4 2024 was $111.9 million, compared to a net loss of $17.6 million in Q4 2023 [30] - Adjusted net income for the year was $119.2 million, up from $0.7 million in 2023, marking an increase of $118.5 million [31] Business Line Data and Key Metrics Changes - The increase in total revenue was primarily driven by higher sales of ASCENIV, which saw increased acceptance and utilization [26][27] - Gross profit for 2024 was $219.6 million, with a gross margin of 51.5%, up from 34.4% in 2023, due to a favorable mix of higher-margin immunoglobulin sales [27] Market Data and Key Metrics Changes - ASCENIV's forward-looking demand metrics are at all-time highs, with the company currently penetrating just over 3% of the targeted market for primary immunodeficiency (PI) [13][14] - The company has secured long-term agreements for high-titer plasma supply from approximately 250 US-based collection centers, increasing collection capacity fivefold [14] Company Strategy and Development Direction - The company anticipates regulatory approval for an enhanced yield production process by mid-2025, which could increase production output by approximately 20% [15][16] - The strategic focus includes expanding ASCENIV's market penetration and addressing unmet needs within the PI patient population [13][18] - The company aims to achieve over $1 billion in total annual revenue by 2030, with additional upside potential from the SG-001 program targeting strep pneumonia [19][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to continue generating strong financial results and expanding margins, supported by a solid balance sheet and increasing net cash position [20][36] - The anticipated increase in high-titer plasma supply is expected to meet growing demand and accelerate revenue and earnings growth [17][37] Other Important Information - The company is undergoing an audit process with KPMG, which is expected to enhance the accuracy and quality of financial statements [22][33] - The company has a net cash position exceeding $103 million against $75 million in total debt, providing a strong foundation for strategic initiatives [20][32] Q&A Session Summary Question: Update on third-party supply contracts and expected cadence in 2025 - Management indicated that they are more than 50% of the way to onboarding additional collection centers and are seeing increased plasma collection [42][44] Question: Characterization of the waiting list for new ASCENIV patients - Management confirmed that the queue of prospective patients is growing, and they are onboarding more patients than before [46][48] Question: Long-term guidance and yield enhancement impact - Management clarified that the 2025 guidance does not include yield enhancement, which could provide significant upside in 2026 [59][61] Question: Gross margins expectations for ASCENIV - Management expects ASCENIV's gross margins to remain above 80%, with yield enhancement further improving margins [90][92] Question: FDA review process for enhanced yield - Management expressed confidence that no preapproval inspection is required for the enhanced yield process and anticipates timely approval [94][96] Question: Timeline for SG-001 animal data and clinical entry - Management is optimistic about the rapid progress of SG-001 and expects to have animal data later this year, with potential clinical entry before 2030 [98][100]

Financial Performance - Total revenue for FY 2024 reached $426.5 million, marking a 65% year-over-year increase from $258.2 million in FY 2023 [14][16] - GAAP net income for FY 2024 was $197.7 million, a significant turnaround from a net loss of $28.2 million in FY 2023 [16] - Adjusted EBITDA for FY 2024 was $164.6 million, reflecting a 309% increase compared to $40.2 million in FY 2023 [17] - Adjusted net income for FY 2024 was $119.2 million, a dramatic rise from $0.7 million in FY 2023, representing a 16,810% increase [17] Cash Flow and Balance Sheet - Year-end 2024 total cash grew to over $103 million, including $60 million of debt that was organically discharged during the second half of 2024 [18] - The company generated approximately $48 million in operating cash flow in Q4 2024, contributing to a strong cash position [7] Future Guidance - Total revenue guidance for FY 2025 and 2026 has been increased to more than $490 million and $605 million, respectively [4] - Adjusted net income guidance for FY 2025 and 2026 has been raised to more than $175 million and $235 million, respectively [4] - Adjusted EBITDA guidance for FY 2025 and 2026 has been increased to more than $225 million and $305 million, respectively [7] Strategic Developments - The company anticipates generating over $1 billion in total annual revenue prior to 2030, more than doubling the current 2025 revenue forecast [2] - Long-term high-titer plasma supply contracts are expected to provide a foundation for durable ASCENIV revenue growth through the late 2030s [3][7] - FDA approval of a yield enhancement production process is anticipated by mid-2025, which could increase production yields by approximately 20% [3][7] Market Position and Product Demand - ASCENIV demand is projected to drive record highs into 2025, with expectations for increased penetration in the complex and refractive primary immunodeficiency (PI) target market [7] - The company has executed long-term high-titer plasma supply contracts, significantly increasing access to raw material plasma used for ASCENIV production [7]