ADMA Biologics(ADMA)2025-05-07 21:15Financial 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]