ADMA Biologics (ADMA) has been a consistent market outperformer in recent times. Shares have gained 17.2% in the past three months against the industry’s decline of 10.6%. The stock has also outperformed the sector and the S&P 500 in this timeframe.ADMA Outperforms Industry, Sector & S&P 500Image Source: Zacks Investment ResearchADMA Biologics markets plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases.Though the first-quarter results (reported ...

ADMA Biologics (ADMA) and Grifols (GRFS) are leading producers of plasma-derived therapies, specializing in immunoglobulin treatments for immunodeficiencies and other conditions.ADMA Biologics markets plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases.Grifols is a leader in essential plasma-derived medicines and transfusion medicine. The company develops, produces, and provides innovative healthcare services and solutions in more than 110 coun ...

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]

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].

分组1 - Adma Biologics reported quarterly earnings of $0.14 per share, missing the Zacks Consensus Estimate of $0.16 per share, but showing an increase from $0.08 per share a year ago, resulting in an earnings surprise of -12.50% [1] - The company posted revenues of $114.8 million for the quarter ended March 2025, which was 3.61% below the Zacks Consensus Estimate, compared to $81.88 million in the same quarter last year [2] - Adma Biologics has surpassed consensus EPS estimates two times over the last four quarters and topped consensus revenue estimates three times during the same period [2] 分组2 - The stock has increased approximately 34.8% since the beginning of the year, contrasting with a -4.7% decline in the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is $0.16 on revenues of $121.1 million, and for the current fiscal year, it is $0.71 on revenues of $495.8 million [7] - The Medical - Biomedical and Genetics industry, to which Adma Biologics belongs, is currently ranked in the top 35% of over 250 Zacks industries, indicating a favorable outlook for the sector [8]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 reached $114.8 million, a year-over-year increase of $32.9 million, translating to approximately 40% growth [10][18] - Adjusted for voluntary product withdrawals, revenues would have been $118.6 million, representing approximately 45% year-over-year growth [10][18] - Adjusted net income grew by 87% year-over-year to $33.3 million, while adjusted EBITDA increased by 81% to $47.9 million [20][21] Business Line Data and Key Metrics Changes - The increase in total revenue is primarily attributed to higher sales of Ascentive, reflecting increased acceptance and utilization by physicians, payers, and patients [19] - Gross profit for Q1 2025 was $61.1 million, with a gross margin of 53.2%, up from 47.8% in Q1 2024, driven by a favorable mix of higher margin IG sales [19][20] Market Data and Key Metrics Changes - Demand for commercial products, particularly BIVIGAM and Ascentive, has consistently exceeded prior supply capabilities, with new patient starts continuing to grow [12][13] - The company anticipates significant sequential operating cash flow growth throughout 2025, supported by a strong balance sheet with cash and receivables totaling $171 million at the end of Q1 2025 [13][21] Company Strategy and Development Direction - The company is focused on advancing its R&D platform and optimizing production capabilities, particularly with the recent FDA approval of the yield enhancement production process, expected to provide 20% more bulk IG from the same plasma volumes [8][9] - A stock repurchase program has been authorized, allowing the company to buy back up to $500 million of its common stock, reflecting confidence in its financial position and commitment to shareholder value [14][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to achieve sustainable revenue and earnings growth, driven by a robust U.S.-based supply chain and favorable market conditions [23][24] - The company has raised its revenue guidance for 2025 to $500 million or more and for 2026 to $625 million or more, reflecting ongoing commercial momentum and the impact of the yield enhancement process [11][12] Other Important Information - The company has successfully reduced its cost of debt through a recent debt reorganization, which is expected to enhance its capital structure and financial flexibility [13][22] - The company remains insulated from government price negotiations affecting other sectors of the pharmaceutical industry, which supports its strong reimbursement profile [15][16] Q&A Session Summary Question: Guidance and FDA Clearance - Inquiry about the guidance increase and the timeline for revenue contribution from the yield enhancement process [29] - Management confirmed that three conformance lots were manufactured for FDA approval and expressed confidence in releasing these lots into the market [30][31] Question: Demand Generation and Capital Allocation - Questions regarding backlog for Ascentive and capital allocation priorities [35][36] - Management indicated that operational expenses are expected to normalize and that cash generation will support debt repayment, R&D funding, and stock repurchases [38][41] Question: Supply Agreements and Donor Retention - Inquiry about the contribution of new supply agreements to plasma sourcing and donor retention strategies [47][52] - Management reported that all new centers are contributing to plasma supply and that donor retention strategies are effective [48][52] Question: Patient Queue and HEOR Data - Questions about managing the patient queue and the status of health economic outcome data [57][62] - Management stated that demand trends are strong and that they expect to publish HEOR data by year-end to support product access [63][64] Question: Voluntary Product Withdrawals and IP Extension - Inquiry about the reasons for voluntary product withdrawals and the potential for extending IP [65][72] - Management clarified that the withdrawals were due to known adverse events and expressed confidence in the defensibility of their IP position [66][72]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 reached $114.8 million, a year-over-year increase of $32.9 million, translating to approximately 40% growth [11][20] - Adjusted for voluntary product withdrawals, revenues would have been $118.6 million, representing approximately 45% year-over-year growth [11][20] - Adjusted net income grew by 87% year-over-year to $33.3 million, while adjusted EBITDA increased by 81% to $47.9 million [12][22] Business Line Data and Key Metrics Changes - The increase in total revenue is primarily attributed to higher sales of Ascentive, reflecting increased acceptance and utilization by physicians, payers, and patients [20] - Gross profit for Q1 2025 was $61.1 million, with a gross margin of 53.2%, up from 47.8% in Q1 2024, driven by a favorable mix of higher margin immunoglobulin sales [21] Market Data and Key Metrics Changes - The company has seen robust demand for its commercial products, particularly Ascentive and BIVIGAM, with new patient starts continuing to grow [13][14] - Cash on hand and accounts receivable grew to a combined $171 million at the end of Q1 2025, providing a strong buffer against market volatility [14][24] Company Strategy and Development Direction - The company is focused on advancing its R&D platform and optimizing production capabilities, particularly with the recent FDA approval of the yield enhancement production process, which is expected to increase bulk immunoglobulin output by 20% [8][12] - A stock repurchase program has been authorized, allowing the company to buy back up to $500 million of its common stock, reflecting confidence in its financial position and future growth [15][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to achieve sustainable revenue and earnings growth, driven by a strong balance sheet and capital flexibility [14][26] - The company anticipates significant growth in cash flow and plans to utilize this for debt reduction, funding R&D, and stock repurchases [43][44] Other Important Information - The company has successfully navigated recent geopolitical and trade challenges due to its U.S.-based supply chain and domestic operations [7][8] - The FDA's approval of the yield enhancement process is seen as a pivotal achievement, validating the company's R&D efforts and enhancing its market position [9][10] Q&A Session Summary Question: Guidance increase and yield enhancement process - Management confirmed that three conformance lots were manufactured to secure FDA clearance, and they are conservatively excluding these from 2025 guidance [31][33] Question: Demand generation and backlog for Ascentive - Management indicated that operational expenses are expected to normalize, and demand indicators for all products are strong, supporting revenue growth [41][42] Question: Supply agreements and plasma collection - Management reported that nearly all new centers are contributing to plasma supply, exceeding initial forecasts and supporting increased guidance [49][51] Question: Health economic outcome data for Ascentive - Management is on track to publish health economic outcome data by year-end, which is expected to resonate with payers and support access to the drug [63][64] Question: Voluntary product withdrawals - Management clarified that the withdrawals were due to known adverse events and are considered a one-time occurrence, with no expected ongoing impacts [66][70] Question: Intellectual property extension - Management expressed confidence in extending the IP for Ascentive and highlighted the robust patent protection in place [72][75]

Financial Performance - Revenues for Q1 2025 were $114,802,000, representing a 40.2% increase from $81,875,000 in Q1 2024[16] - Gross profit for Q1 2025 was $61,097,000, up 56.3% from $39,108,000 in Q1 2024[16] - Net income for Q1 2025 was $26,904,000, compared to $17,806,000 in Q1 2024, marking a 51.1% increase[16] - Basic earnings per share for Q1 2025 were $0.11, up from $0.08 in Q1 2024[16] - Adjusted EBITDA for Q1 2025 was $47.9 million, an increase of $21.5 million compared to $26.4 million in Q1 2024[125] - The income before taxes for the three months ended March 31, 2025, was $33.5 million, compared to $18.4 million for the same period in 2024, representing an increase of 81.5%[83] - The effective tax rate for the three months ended March 31, 2025, was 19.6%, significantly higher than the 3.2% effective tax rate for the same period in 2024[83] - The company achieved net income of $26.9 million for the three months ended March 31, 2025, compared to $17.8 million in the same period in 2024[140] - The company achieved a net income of $197.7 million for the year ended December 31, 2024, marking its first GAAP net income in history, with positive cash flow from operations of $118.7 million[96] Assets and Liabilities - Total current assets increased to $351,814,000 as of March 31, 2025, from $331,410,000 at the end of 2024[14] - Total stockholders' equity rose to $373,419,000 as of March 31, 2025, compared to $349,018,000 at the end of 2024[14] - Total assets of the Company as of March 31, 2025, were $510.6 million, up from $350.9 million as of March 31, 2024, indicating a growth of 45.5%[75] - As of March 31, 2025, total accrued expenses and other current liabilities were $31.6 million, a decrease from $34.0 million at December 31, 2024[48] - The Company has lease liabilities of $9.5 million as of March 31, 2025, with scheduled payments totaling $14.2 million over the remaining lease terms[81] - The Company has a total of $72.5 million in senior notes payable, with a term loan and revolving credit facility both fully drawn as of March 31, 2025[49] - As of March 31, 2025, the outstanding balance on the revolving credit facility was $42.5 million, and the term loan facility was $32.5 million[133] Cash Flow and Expenses - The company reported a net cash used in operating activities of $19,675,000 for Q1 2025, compared to $2,218,000 in Q1 2024[20] - Net cash used in operating activities for the three months ended March 31, 2025, was $19.7 million, an increase of $17.5 million from the same period in 2024[140] - Net cash used in investing activities increased to $4.7 million for the three months ended March 31, 2025, primarily due to a $1.3 million roof replacement at the Boca Facility[141] - Net cash used in financing activities was $7.1 million for the three months ended March 31, 2025, compared to $1.4 million in 2024[142] - The Company incurred research and development expenses of $0.8 million for the three months ended March 31, 2025, compared to $0.5 million for the same period in 2024, reflecting a 83.5% increase[73] - Selling, general and administrative expenses rose to $24.1 million in Q1 2025, an increase of $8.4 million from Q1 2024, with SG&A as a percentage of net revenues increasing from 19.1% to 21.0%[119] Customer Concentration - For the three months ended March 31, 2025, three customers represented approximately 74% of the company's consolidated revenues, compared to two customers representing 70% for the same period in 2024[38] - As of March 31, 2025, accounts receivable included allowances for customer credits and credit losses amounting to $3.0 million, with three customers accounting for approximately 85% of total accounts receivable[29] - For the three months ended March 31, 2025, two customers represented approximately 64% of consolidated revenues, compared to 70% for the same period in 2024[192] - The company anticipates increased revenue from key customers over the next few years, but any adverse change in their financial condition could negatively affect revenue[194] Regulatory and Compliance - The company is currently evaluating the impact of recent accounting pronouncements on its consolidated financial statements, including ASU 2023-09 and ASU 2024-03[42][43] - The FDA approved the Company's Prior Approval Supplement for its yield enhancement production process in April 2025, expected to increase production yields of ASCENIV and BIVIGAM by approximately 20%[85][97] - The FDA approved the expansion of BIVIGAM's label to include pediatric patients aged two years and older in December 2023[105] - The Company plans to file a supplemental Biologics License Application for ASCENIV's label expansion to include pediatric patients in mid-2025, with potential FDA approval in the first half of 2026[101] - The company is subject to periodic inspections by the FDA, which could result in regulatory actions that may materially impact operations[168] Risks and Challenges - The company faces risks from geopolitical and economic conditions, including potential disruptions to the supply chain due to international conflicts and trade policies[167] - The company may not be able to accurately forecast revenue due to uncertainties in market opportunity estimates and growth forecasts[165] - The company faces significant costs and time delays in obtaining regulatory approval for product candidates, which may impact business operations[173] - The company may not be able to generate revenue from product candidates if regulatory approvals are not obtained, limiting revenue sources to plasma collection and sales[182] - The company relies on third-party contractors for filling, packaging, testing, and labeling, which poses risks of delays and quality issues that could adversely affect commercialization efforts[160] - The company is subject to numerous environmental, health, and safety laws, which could result in substantial fines or penalties if compliance is not maintained[171] Operational Developments - The company continues to focus on developing a pipeline of plasma-derived therapeutics for immunocompromised patients[21] - The Company entered into an Amended and Restated Plasma Purchase Agreement with Grifols, requiring a minimum supply of 35,000 liters of RSV plasma annually[66] - The Company is currently focused on expanding its manufacturing capacity and product output capability at its Boca Facility, which may lead to supply shortages during the validation process[189] - The Company operates ten FDA-licensed plasma collection facilities, capable of collecting approximately 30,000 to 50,000 liters of source plasma annually per facility[94] Market and Competitive Landscape - The company faces intense competition in the biotechnology and pharmaceutical industries, with competitors having greater financial resources and R&D capabilities[207] - The acceptance and use of the company’s products by physicians, payers, and patients are critical for revenue generation, influenced by safety perceptions and cost-effectiveness[199] - The market exclusivity of products is critical, as significant revenue declines can occur once exclusivity expires and generics are introduced[209] Stock and Financing - In May 2025, the Board of Directors authorized a share repurchase program of up to $500 million of the Company's outstanding shares[86] - The Company entered into a senior secured credit facility with Ares Capital Corporation, providing a total of $135.0 million in credit facilities, fully drawn on December 18, 2023[132] - On May 5, 2025, the company borrowed $30 million under the revolving credit facility and repaid an additional $30 million against the term loan[206]

Financial Performance - 1Q 2025 total revenue reached $114.8 million, a 40% year-over-year increase from $81.9 million in 1Q 2024[1][7] - Adjusted total revenue for 1Q 2025 was $118.6 million, representing approximately 45% year-over-year growth when excluding one-time product withdrawals[1][7] - GAAP net income for 1Q 2025 was $26.9 million, a 51% increase compared to $17.8 million in 1Q 2024[1][9] - Adjusted EBITDA for 1Q 2025 was $47.9 million, reflecting an 81% year-over-year growth from $26.4 million in 1Q 2024[1][10] - Total revenue for Q1 2025 was $114.8 million, a 40.2% increase from $81.9 million in Q1 2024[21] - Gross profit for Q1 2025 was $61.1 million, compared to $39.1 million in Q1 2024, reflecting a significant improvement in profitability[21] - Adjusted revenues for Q1 2025, including customer credits related to the Voluntary Withdrawal, were $118.6 million[22] - Net income for Q1 2025 was $26.9 million, up from $17.8 million in Q1 2024, representing a 51.5% year-over-year increase[21] - Adjusted EBITDA for Q1 2025 was $47.9 million, compared to $26.4 million in Q1 2024, indicating strong operational performance[24] - The company reported a basic earnings per share of $0.11 for Q1 2025, up from $0.08 in Q1 2024[21] Guidance and Projections - FY 2025 total revenue guidance increased to more than $500 million, with FY 2026 guidance raised to over $625 million[2][5] - FY 2025 adjusted net income guidance reaffirmed at $175 million or more, while FY 2026 adjusted net income guidance increased to $245 million[2][5] - Anticipated total annual revenues prior to 2030 are now projected to exceed $1.1 billion, with expected outsized earnings growth[2][5] Cash and Assets - Total cash and receivables grew to approximately $171 million by the end of 1Q 2025[1][4] - Cash and cash equivalents decreased to $71.6 million as of March 31, 2025, from $103.1 million at the end of 2024[19] - Total assets increased to $510.6 million as of March 31, 2025, compared to $488.7 million at the end of 2024[19] Shareholder Actions - The company authorized a $500 million share repurchase program, representing approximately 8% of its current market capitalization[2][4] Operational Enhancements - The FDA approved a yield enhancement process expected to increase production output by 20% from the same starting plasma volume[2][4] - The company plans to further pay down its outstanding debt, with senior notes payable at $72.5 million[19] - The company is focused on expanding its plasma supply agreements to enhance ASCENIV's growth and financial performance[21]

Core Insights - ADMA Biologics reported a strong financial performance in Q1 2025, with total revenue of $114.8 million, representing a 40% year-over-year increase, and adjusted total revenue of $118.6 million, indicating approximately 45% growth when excluding one-time product withdrawals [1][9] - The company achieved a GAAP net income of $26.9 million, a 51% increase year-over-year, and an adjusted net income of $33.3 million, reflecting an 87% year-over-year growth [1][11] - Adjusted EBITDA for the quarter was $47.9 million, marking an 81% increase compared to the same period last year [1][12] Financial Performance - Total cash and receivables grew to approximately $171 million, providing a strong liquidity position [1][3] - The gross profit for Q1 2025 was $61.1 million, translating to a gross margin of 53.2%, up from 47.8% in Q1 2024 [10] - The company has increased its total revenue guidance for FY 2025 to more than $500 million and for FY 2026 to more than $625 million [1][7] Strategic Developments - The FDA approved a yield enhancement production process, expected to increase production output by 20% from the same starting plasma volume, which is anticipated to support revenue growth and margin expansion [1][3] - ADMA has authorized a $500 million share repurchase program, representing approximately 8% of its current market capitalization, aimed at enhancing stockholder value [1][8] - A debt reorganization has reduced ADMA's cost of debt capital by 1.1%, further strengthening its financial position [1][3] Market Position and Outlook - The company expects total annual revenues to exceed $1.1 billion by 2030, with significant earnings growth anticipated from current margin levels [2][7] - ADMA's U.S.-based manufacturing and supply chain provide insulation from geopolitical and global trade challenges, positioning the company favorably against multinational competitors [3][7] - The demand for ASCENIV, one of ADMA's key products, continues to trend towards record highs, with expectations for increased market penetration and new patient starts [4][7]