Key Takeaways ADMA expects ~$510$511M in 2025 revenues and ended the year with about $88M in cash.ADMA lifted 2026 revenue guidance to ~$635M and raised EBITDA outlook on yield-enhanced production.ADMA sees accelerating Asceniv demand, broader plasma access, and margin expansion driving growth into 2027.ADMA Biologics, Inc. (ADMA) announced preliminary unaudited full-year 2025 revenue numbers and provided a business update.The company estimates total revenues of approximately $510-$511 million for 2025. ADM ...

Summary of ADMA Biologics FY Conference Call Company Overview - **Company Name**: ADMA Biologics - **Ticker Symbol**: ADMA (NASDAQ) - **Industry**: Biologics, specifically plasma-derived products - **Headquarters**: Ramsey, New Jersey; manufacturing in Boca Raton, Florida; plasma center operations in North Carolina - **Key Products**: IVIG products, including Asceniv and Bivigam Financial Performance - **Total Revenue**: Pre-announced $510 million for the fiscal year 2025, with Q4 revenue exceeding $139 million [2][3] - **EBITDA**: Expected to be between $77-$78 million for Q4 2025, with net income projected at over $50 million [3] - **2026 Guidance**: Forecasting $635 million in revenue and $360 million in EBITDA [24] - **2027 Guidance**: First-time guidance of $775 million in revenue and $455 million in EBITDA [24] Product and Market Insights - **Asceniv**: Unique polyclonal immunoglobulin targeting patients with primary immunodeficiency (PI) and respiratory syncytial virus (RSV) [12][13] - **Market Size**: The immunoglobulin market is projected to grow from over $13 billion in 2024 to over $30 billion by 2033 [10] - **Target Patient Population**: Approximately 250,000 patients with PI, with ADMA targeting about 25,000 patients who do not respond well to standard IG therapy [11][12] Strategic Developments - **Plasma Collection Network**: Currently operates 10 plasma centers, divesting three centers while expanding third-party plasma collection from 250 to 280 centers [4][5] - **Yield Enhancement Strategy**: Achieved a 20% increase in manufacturing yield, allowing for more finished goods from the same raw material [19][44] - **FDA Approval**: First company to receive FDA approval for yield enhancement manufacturing strategy [6][19] Growth Opportunities - **Pipeline Expansion**: Plans to submit a pre-IND package for SG01, a new product expected to generate $300-$500 million in revenue [22][23] - **Pediatric Market**: Anticipating label expansion for Asceniv to include pediatric patients aged 2 to 12 [21] - **Distribution Partnerships**: New agreement with McKesson Specialty to enhance distribution capabilities [18] Operational Efficiency - **Cost Management**: Divestiture of plasma centers expected to reduce operating costs by $13-$15 million [25][40] - **Production Mix**: Shift towards higher production of Asceniv, projected to account for 90% of revenue by 2029 [17] Competitive Landscape - **Market Position**: ADMA is the last U.S.-based producer of intravenous immune globulins, insulated from low-cost competition from emerging markets [6] - **Innovation**: Focus on capital-efficient R&D and leveraging proprietary technology for product differentiation [23][38] Conclusion - ADMA Biologics is positioned for significant growth with a strong financial outlook, innovative product offerings, and strategic operational efficiencies. The company is focused on expanding its market share in the U.S. while exploring future opportunities in pediatric care and new product development.

Core Insights - Adma Biologics has seen a 43.3% increase in share price since its last earnings report, outperforming the S&P 500 [1] - The company reported Q3 2025 adjusted EPS of 16 cents, matching estimates, with revenues of $134.2 million, a 12% year-over-year increase, surpassing expectations [2] - Asceniv, the lead product, has driven growth with record utilization due to strong prescriber adoption and patient demand [6] Financial Performance - Revenues for Q3 2025 were $134.2 million, exceeding the Zacks Consensus Estimate of $130 million [2] - Gross margin improved to 56.3% from 49.8%, attributed to a favorable mix of higher-margin immunoglobulin sales and operational efficiencies [6] - Research & Development expenses rose significantly to $1.5 million from $0.4 million year-over-year, while selling, general, and administrative expenses increased by 17.3% to $21.8 million [6] Product and Market Developments - ADMA's product lineup includes three FDA-approved products: Bivigam, Asceniv, and Nabi-HB [4] - The company received FDA lot release authorization for yield-enhanced commercial batches, expected to improve manufacturing efficiency and gross margin starting Q4 2025 [7] - ADMA is negotiating to onboard additional distribution partners to expand the reach of Bivigam and Asceniv [9] Future Guidance - ADMA has updated its revenue guidance for 2025 to over $510 million and for 2026 to $630 million [8] - Net income projections for 2025 have been adjusted to exceed $158 million due to a higher effective tax rate, while 2026 projections have increased to exceed $255 million [8] Research and Development - ADMA is advancing SG-001, a hyperimmune globulin targeting S. pneumonia, with a potential market opportunity of $300-$500 million annually if successful [10][11] - A CNPV application has been submitted for SG-001, which could accelerate FDA review by two quarters or more [11] Industry Context - Adma Biologics operates within the Zacks Medical - Biomedical and Genetics industry, which includes other players like Vertex Pharmaceuticals [16] - Vertex reported revenues of $3.08 billion for the last quarter, reflecting an 11% year-over-year increase, and is expected to post earnings of $4.98 per share for the current quarter, a 25.1% increase year-over-year [16][17]

Core Insights - ADMA Biologics reported third-quarter 2025 adjusted earnings per share (EPS) of 16 cents, matching the Zacks Consensus Estimate, and an increase from 15 cents in the same quarter last year [1] - Revenues reached $134.2 million, a 12% year-over-year increase, surpassing the Zacks Consensus Estimate of $130 million [1] - Despite positive earnings and revenue growth, ADMA's stock fell 2.9% in after-market trading, with shares down 12.9% year to date compared to the industry's growth of 10.3% [1] Financial Performance - Asceniv, a key product, achieved record utilization due to strong prescriber adoption and growing patient demand [5] - Gross margin improved to 56.3% from 49.8%, attributed to a favorable mix of higher-margin immunoglobulin sales and operational efficiencies [5] - Research & Development expenses increased significantly to $1.5 million from $0.4 million in the previous year, while selling, general, and administrative expenses rose 17.3% to $21.8 million [5] Product and Market Developments - ADMA's product lineup includes three FDA-approved products: Bivigam, Asceniv, and Nabi-HB, targeting immune deficiencies and infectious diseases [3] - The company received FDA lot release authorization for yield-enhanced commercial batches, expected to improve manufacturing efficiency and gross margin starting in Q4 2025 [8] - ADMA is actively negotiating to onboard additional distribution partners to expand the reach of Bivigam and Asceniv [10] Future Guidance - ADMA raised its revenue guidance for 2025 to over $510 million (previously $500 million) and for 2026 to $630 million (previously $625 million) [9] - Net income projections for 2025 were adjusted to exceed $158 million (previously $175 million) due to a higher effective tax rate, while 2026 net income is projected to exceed $255 million (previously $245 million) [9] Pipeline and Strategic Initiatives - ADMA is advancing SG-001, a hyperimmune globulin targeting S. pneumonia, with a CNPV application submitted that could accelerate FDA review [11] - If successful, SG-001 could represent a high-margin opportunity of approximately $300-$500 million annually, protected through at least 2037 [11] - The company anticipates constructive payer negotiations in 2026 to expand coverage and support growth [12]

Core Insights - ADMA Biologics reported better-than-expected Q2 results with adjusted earnings per share of 15 cents, beating the Zacks Consensus Estimate by a penny, and revenues of $122 million, up 14% year over year, also surpassing the estimate of $121 million [1][8] - Despite the positive results, ADMA's stock fell 7.4% in after-market trading, and year-to-date shares have decreased by 4.4% compared to the industry's growth of 0.2% [1] Financial Performance - The company's revenue growth was primarily driven by the strong adoption of its lead product, Asceniv, which contributed to a 29% year-over-year growth in underlying revenues, excluding a $12.6 million Medicaid rebate accrual reversal [6][8] - Gross margin improved to 55.1% from 53.6%, with underlying gross margin expanding by 7.7% year over year due to a favorable mix of higher-margin immunoglobulin sales and operational efficiencies [7] - Research & Development expenses increased by 84% to $1 million, while selling, general, and administrative expenses rose by 33.7% to $22.2 million [7] Product and Market Developments - ADMA's product portfolio includes three FDA-approved products: Bivigam, Asceniv, and Nabi-HB, with Asceniv being the lead product for treating primary immunodeficiency disease [4][5] - The company anticipates significant growth rates in the second half of 2025, with a revenue potential exceeding $1.1 billion from plasma products before 2030 [10][12] - ADMA is initiating SG-001, a hyperimmune globulin targeting S. pneumonia, with promising initial pilot testing results showing no clinical signs of pneumonia in treated animals [13][14] Strategic Investments - In July, ADMA completed the purchase of a $12.5 million facility adjacent to its Boca Raton manufacturing campus, enhancing its U.S.-based vertically integrated supply chain and potentially increasing future cGMP capacity by up to 30% [15]

Core Insights - ADMA Biologics and Takeda are prominent players in the plasma-derived immunoglobulin sector, with ADMA focusing on treatments for immune deficiencies and Takeda having a diversified portfolio across various therapeutic areas [1][8]. ADMA Biologics - ADMA markets three FDA-approved plasma-derived products: Bivigam, Asceniv, and Nabi-HB, targeting immune deficiencies and infectious diseases [3][10]. - Asceniv, ADMA's lead product, is a plasma-derived IVIG that contains polyclonal antibodies, crucial for neutralizing microbes [4][5]. - Record demand for Asceniv was noted in Q1, with expectations for revenue growth through 2025 and plans for a pediatric label expansion filing by mid-2025 [6][10]. - ADMA anticipates proof-of-concept data for its pipeline program SG-001 by the end of 2025, with potential annual revenues of $300-500 million [7]. Takeda - Takeda's plasma-derived therapies (PDT) business unit has shown 9% growth in 2024, supported by a broad immunoglobulin portfolio including Hyqvia, Cuvitru, and Gammagard [8][10]. - Hyqvia is notable for being the only subcutaneous IG treatment for primary immunodeficiencies, requiring fewer infusions [11]. - Takeda is actively developing next-generation immunoglobulin products and has partnered with other companies to enhance its pipeline [13][14]. Financial Estimates and Performance - The Zacks Consensus Estimate for ADMA's 2025 sales indicates an 18.61% year-over-year increase, while EPS estimates have shown mixed movements [15]. - In contrast, Takeda's 2025 sales estimates suggest a 2.80% decrease, with EPS showing a 6.21% improvement [16]. - Year-to-date, Takeda's stock has outperformed ADMA, with gains of 13.91% compared to ADMA's 4.1% [18]. - Valuation metrics indicate ADMA is trading at 21.79X forward earnings, significantly higher than Takeda's 9.03X [18]. Investment Considerations - Takeda is recognized for its stability and broad portfolio, making it a safer investment choice, while ADMA's growth potential is tied to the expansion of Asceniv [21][22]. - Despite Takeda's current ranking as a "Sell," ADMA's revenue potential from Asceniv positions it as a more attractive investment opportunity at present [22][23].

Core Viewpoint - ADMA Biologics has shown strong market performance, with a 17.2% increase in shares over the past three months, outperforming the industry and the S&P 500 [1][3]. Company Overview - ADMA Biologics specializes in plasma-derived biologics aimed at treating immune deficiencies and preventing certain infectious diseases [4]. - The company's lead product, Asceniv, is an Intravenous Immune Globulin (IVIG) that contains polyclonal antibodies to help neutralize microbes [5]. Financial Performance - Despite lower-than-expected first-quarter results, ADMA raised its revenue guidance for 2025 to over $500 million and for 2026 to $625 million, up from previous estimates of over $490 million and $605 million respectively [10]. - Projected net income is expected to exceed $175 million in 2025 and increase to $245 million or more in 2026 [10]. Growth Prospects - Demand for Asceniv reached record highs in the first quarter, with expectations for revenue share to expand throughout 2025 and beyond [7]. - ADMA plans to file for a supplemental Biologics License Application in mid-2025 to expand Asceniv's label to include pediatric patients aged two years and older, which could increase the target patient population [8][9]. Valuation - Currently, ADMA's shares are considered expensive, trading at a price/sales ratio of 8.44x forward sales, significantly higher than its historical mean of 3.33x and the industry average of 1.69x [11]. Market Position - ADMA competes with Takeda and Grifols in the U.S. plasma-derived products market and is expected to maintain momentum in the upcoming quarters [15]. - The targeted market for ADMA's products has significant growth potential, particularly among underserved immune-compromised and co-morbid patient populations [16].

Core Viewpoint - ADMA Biologics and Grifols are prominent players in the plasma-derived therapies market, each with unique strengths and growth prospects, making stock selection challenging [1][2]. Company Overview ADMA Biologics - ADMA specializes in plasma-derived biologics for treating immune deficiencies and preventing infectious diseases, with three FDA-approved products: Bivigam, Asceniv, and Nabi-HB [3][6]. - Asceniv, the lead product, is a plasma-derived IVIG that contains polyclonal antibodies to neutralize microbes [4][5]. - The company anticipates significant revenue growth from Asceniv, driven by record demand and plans for a new R&D program, SG-001, which could generate $300-500 million in annual revenues [6]. Grifols - Grifols is a global leader in plasma-derived medicines, developing a wide range of biological therapies targeting various immunological conditions [7][8]. - The company reported sales of €7.2 billion in 2024, reflecting a 10.3% increase, and is recognized as the largest producer of A1PI [9][10]. - Grifols has a diverse portfolio and is positioned for consistent growth due to strong demand and operational execution [11]. Financial Estimates ADMA Biologics - The Zacks Consensus Estimate for ADMA's 2025 sales indicates an 18.61% year-over-year increase, with EPS expected to improve by 36.73% [12]. - Recent estimate revisions show a decline in EPS estimates for 2025 but an increase for 2026 [13]. Grifols - The Zacks Consensus Estimate for Grifols' 2025 sales suggests a 3.78% increase, with EPS expected to rise by 296% [12]. - EPS estimates for both 2025 and 2026 have seen upward revisions in the past 60 days [15]. Price Performance and Valuation - Year-to-date, ADMA shares have increased by 15.9%, outperforming Grifols' 10.6% rise, while the industry has declined by 4.1% [16]. - In terms of valuation, ADMA trades at 25.48X forward earnings, significantly higher than Grifols' 7.19X [16]. Investment Recommendation - ADMA shows steady growth driven by Asceniv demand, while Grifols, with a broader portfolio and better valuation, is considered a more favorable investment choice at present [20][21][22].

Core Viewpoint - ADMA Biologics reported lower-than-expected first-quarter results, with adjusted earnings per share of 14 cents missing the consensus estimate of 16 cents, and revenues of $114.8 million, up 40% year over year, also falling short of the expected $119 million. Despite this, the company raised its revenue guidance for 2025 and 2026 [1][8]. Group 1: Financial Performance - The first-quarter adjusted earnings per share were 14 cents, missing the Zacks Consensus Estimate of 16 cents [1]. - Revenues for the first quarter were $114.8 million, which is a 40% increase year over year but below the expected $119 million [1]. - ADMA updated its revenue guidance, now expecting over $500 million in 2025 and $625 million in 2026, an increase from previous estimates of over $490 million and $605 million respectively [8]. Group 2: Product and Market Insights - ADMA markets plasma-derived biologics, including three FDA-approved products: Bivigam, Asceniv, and Nabi-HB, targeting immune deficiencies and infectious diseases [3]. - Asceniv, the lead product, is a plasma-derived IVIG that contains polyclonal antibodies to treat primary immunodeficiency disease (PIDD) [4][5]. - Demand for Asceniv was record high in the first quarter, with expectations for revenue share to expand throughout 2025 and beyond due to new patient starts and increased penetration in existing institutions [6]. Group 3: Growth Prospects - ADMA is developing SG-001, a hyperimmune globulin targeting S. pneumonia, with potential annual revenues of $300-500 million expected by 2025 [7]. - The company anticipates significant growth opportunities in the underserved immune-compromised and co-morbid patient population, despite competition from standard-of-care therapies [19]. - The recent FDA approval for an innovative yield enhancement production process supports revenue growth and margin expansion opportunities [21]. Group 4: Stock Performance and Valuation - ADMA's shares have surged 37.7% year to date, outperforming the industry, which has declined by 7.4% [11]. - The current price/sales ratio for ADMA is 10.46x forward sales, significantly higher than its historical mean of 3.32x and the industry average of 1.65x, indicating a high valuation [14].

Core Viewpoint - ADMA Biologics is expected to report first-quarter 2025 results on May 7, with sales estimated at $119.1 million and earnings at 16 cents per share, reflecting a positive trend in earnings estimates for 2025 and 2026 [1][2][16]. Financial Performance - The earnings estimate for 2025 has increased to 71 cents from 69 cents per share over the past 60 days, while the estimate for 2026 has improved to 93 cents from 87 cents [1][2]. - ADMA has a mixed earnings surprise history, beating estimates in three of the last four quarters with an average surprise of 32.8%, although it missed estimates by 6.67% in the most recent quarter [2][3]. Product Overview - ADMA markets plasma-derived biologics, including three FDA-approved products: Bivigam, Asceniv, and Nabi-HB, aimed at treating immune deficiencies and preventing infectious diseases [6][17]. - Asceniv, the lead product, is a plasma-derived IVIG that contains polyclonal antibodies to neutralize microbes and prevent infections [7][8]. Sales and Growth Drivers - Increased sales of Asceniv are expected to drive revenue growth in the first quarter, supported by a favorable mix of high-margin immunoglobulin sales [9]. - ADMA anticipates significant growth in revenues, projecting over $490 million in 2025 and $605 million in 2026, with net income expected to exceed $175 million in 2025 [16]. Market Position and Strategy - ADMA has entered into long-term high-titer plasma supply contracts, increasing access to raw materials and potentially achieving $1 billion in annual revenues by 2030 [14]. - The company competes with Takeda and Grifols in the U.S. plasma-derived products market and is positioned for substantial growth in the underserved immune-compromised patient population [17][18]. Valuation - ADMA's shares currently trade at a price/sales ratio of 10.59x forward sales, significantly higher than its historical mean of 3.32x and the industry average of 1.76x, indicating a premium valuation [12]. Price Performance - ADMA's stock has surged 38.8% year-to-date, outperforming the industry, which has declined by 2.7% [10].