Enlonstobart

//   • 仍未有真正意义上的创新产品上市； • 新诺威在收购上频繁出手，意图越来越明确； • 新诺威2024Q3营业收入和净利润均同比下降； • 真正的创新重头戏应该是ADC。 石药正在遭遇净利润的压力。2024年三季报的盈利预警显示，公司前三季度净利润约37.75亿人民币，同比下降16%，主要由于成药业务收入较去年同期减少约3%所致。中泰国际证券将其目标价下调至5.18港元。较早前的10月21日，瑞银减持石药1774万股。 截至2024年，石药这艘“航母”在港股市场沉浮了30年。作为第一家被纳入恒生指数的医药企业，石药当下市值607亿港元，过去十年涨幅150%。另一边，2000年迈入A股市场的恒瑞医药，如今的市值已经突破3000亿，过去十年涨幅超过500%。也许是看到这种巨大的落差，石药决心要在A股市场拿到一张“创新药”的入场券。 石药曾在2020年的一份公告中流露出科创板上市的想法，这应该是其进入A股的最初计划，后来被搁置的原因不得而知。而最近，子公司新诺威在收购上频繁出手，意图越来越明确。 仿创老产品还没找到接替者 如果单纯从已上市产品来看，石药在创新上的转身并没有预想中的那么敏捷。尽管目前公司在研的创新药项目近130项，但是短期之内，尚没有一款真正意义上的创新产品上市。 1997年，石家庄的四家药企“强强联合”成立了石药集团。蔡东晨当选为董事长，并一直执掌至今。在诸多以原料药起家的传统药企中，石药应该是最早迈入新药赛道的。 2005年，一款治疗急性缺血性脑卒中的产品恩必普（丁苯肽），成为脑血管领域第一个拥有知识产权的1类新药。由此奠定了石药在脑卒中领域的地位和研发布局。直到现在，恩必普仍然是石药的核心支柱产品。2023年销售额70亿元。由于其中一个重要含活性的化合物专利2032年才到期，恩必普还没有被纳入仿制药参比制剂。 据中泰证券的研究报告透露，今年下半年以来恩必普受医保控费影响明显加剧，第三季度单季收入同比转跌，导致该板块前三季度的收入增速将从上半年的15%大幅缩小至4%。 不过，专利到期的风险只是时间问题。石药正在准备一个接棒者。 今年2月，三代溶栓药物明复乐（重组人TNK组织型纤溶酶原激活剂）适应症从心血管领域延伸到神经系统领域，获批用于急性缺血性卒中患者的溶栓治疗（发病<4.5h），为同类产品在中国首批。 肿瘤产品作为石药的另一大支柱，升白药津优力和脂质体抗肿瘤药物多美素仍在集采的阴影之下，导致肿瘤业务收入整体下降明显。今年第三季度津优力与多美素受集采影响销售跌幅扩大，导致前三季度肿瘤药板块收入的同比跌幅从上半年的10%扩大至18%。 4亿研发费用输血之后 10月23日，新诺威公布了三季报。前三季度，公司实现营业收入14.79 亿元，同比下降23.66%，净利润1.39亿元，同比下降63.5%。除了主营业务咖啡因和保健品表现不佳之外，为巨石生物支付的研发费用也是影响业绩的重要原因。 2023年，新诺威完成了对巨石生物的收购。老瓶装新酒之后，新诺威更名为石药创新，并开始支撑起巨石生物的研发开支。2024年前三季度，巨石生物研发费用4.04亿元。2024年7~9月研发费用1.86亿元，较2023年7~9月同比增加 48.4%，较2024 年4~6月环比增加 56.6%。 另一笔76亿的收购费用也将由新诺威买单。交易完成后，新诺威拥有石药百克100%股权。意味着，石药在A股市场将再度加入“创新药”基因。 CAR-T、ADC和mRNA：谁先兑现未来 CAR-T可能是石药在创新上的一张隐秘的王牌。10月25日，石药宣布，首款基于mRNA-LNP的CAR-T疗法SYS6020已获批在中国开展重症肌无力适应症的临床试验。此前，该产品已经获得多发性骨髓瘤以及系统性红斑狼疮的临床试验批准。 实际上，从整体管线布局来看，石药的创新更像是一个保守的激进者。即将实现业绩贡献的两款创新产品是PD-1产品恩朗苏拜单抗、奥马珠单抗。10月8日，巨石研发的国产首仿奥马珠单抗，获批用于H1抗组胺药治疗后仍有症状的成人和12岁及以上青少年慢性自发性荨麻疹患者。此外，治疗哮喘的适应症也已申报上市。 恩朗苏拜单抗也在今年6月获批上市，用于治疗至少一线含铂方案化疗失败的PD-L1表达阳性的复发或转移性宫颈癌患者。目前，这两个资产都在A股上市公司新诺威（石药创新）旗下。 成立于2019年的巨石生物，曾经最大的光环是研发了首个国产获批上市的mRNA疫苗。尽管，新冠疫苗的价值已退出历史舞台，但巨石在mRNA疫苗领域的研发布局还在继续。今年上半年，公司的呼吸道合胞病毒mRNA疫苗获临床默认许可。此外，还有带状疱疹病毒及肿瘤等预防性和治疗性mRNA疫苗在研。 真正的重头戏应该是ADC。去年ESMO上，巨石公布了HER2 ADC 产品DP303c治疗HER2表达晚期实体瘤的1期临床数据：在66例可评估疗效的乳腺癌患者中，客观缓解率（ORR）为51.5%，疾病控制率（DCR）为77.3%。目前，DP303c正在国内开展与恩美曲妥珠单抗（T-DM1）“头对头”的3期临床试验。 还有另一款Nectin-4 ADC SYS6002，目前全球同类产品仅有Seagen/安斯泰来的Padcev上市。在2024年ASCO上，巨石公布了SYS6002的1期剂量递增数据。在≥1.2mg/kg剂量组宫颈癌患者中，ORR为43%，DCR为86%。除了宫颈癌之外，有分析师表示，看好SYS6002未来在尿路上皮癌一线治疗的潜力。 去年，巨石生物与Corbus Pharmaceuticals就SYS6002达成开发及商业化订立独家授权协议。巨石生物将收取750万美元的首付款，以及最多5.55亿美元的潜在销售里程碑付款，总交易金额高达6.925亿美元。 另有一款 CLDN18.2 ADC产品，在今年与Elevation Oncology达成研发与商业化协议，并获得2700万美元的首付款以及最多10.2亿美元的潜在销售里程碑付款。 即将被装入上市公司的石药百克，手里的津优力在集采之下业绩疲软。另有几款在研产品似乎乏善可陈，分别是：围绕糖尿病和减重的重组胰高血糖素样肽-1 Fc融合蛋、2型糖尿病治疗的艾塞那肽、转移性结直肠癌的anti-EGFR 单抗、肿瘤骨转移及骨质疏松的anti-RANKL单抗。 保守的激进者 如果要说创新，石药近期和AZ达成交易的的一款小分子降脂药物YS2302018，看起来更有潜力。这是一款口服脂蛋白(a)抑制剂，用于多种心血管疾病的单一疗法或联合疗法，包括与口服小分子PCSK9抑制剂AZD0780联用。 脂蛋白(Lp(a))被视为下一代降脂重磅药物的潜力靶点，诺华旗下的Pelacarsen已进入临床3期。石药的这款YS2302018，目前处在临床前阶段，是由AI驱动的小分子药物设计平台发现。对于并不缺钱的石药来说，AZ的1亿美元首付款真的非常有吸引力吗？或者说，石药在临床前的创新产品研发上还有一些保守。 近期，刘勇军博士出任石药研发总裁，或许会给石药在创新上带来新的计划和决心。 编辑 | 姚嘉 yao.jia@PharmaDJ.com  总第2246期 访问研发客网站，深度报道和每日新闻抢鲜看 www.PharmaDJ.com

3Q 2024 Total Revenue of $119.8 Million, a 78% Increase Y-o-Y 3Q 2024 GAAP Net Income of $35.9 Million, a 1,300% Increase Y-o-Y 3Q 2024 Adjusted EBITDA(1) of $45.4 Million, a 256% Increase Y-o-Y KPMG LLP Engaged as New Independent Registered Public Accounting Firm FY 2024 and 2025 Total Revenue Guidance Increased to More Than $415 Million and $465 Million, Respectively FY 2024 and 2025 GAAP Net Income Guidance Increased to More Than $120 Million and $165 Million, Respectively FY 2024 and 2025 Adjusted EBITDA Guidance Increased to More than $160 Million and $215 Million, Respectively Conference Call Scheduled for Today at 4:30 p.m. ET RAMSEY, N.J. and BOCA RATON, Fla., Nov. 07, 2024 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA,” the “Company,” or “we”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced its third quarter 2024 financial results and provided a business update. “ADMA delivered an outstanding third quarter, building on the momentum from the prior period with realized growth on both the top and bottom lines,” said Adam Grossman, President and Chief Executive Officer of ADMA. “As we enter the fourth quarter of 2024, we anticipate increasing gross margins, driven by a continued revenue mix shift toward ASCENIV. With increasing clarity around a potential billion-dollar revenue opportunity, ADMA’s growth prospects over both the near- and longer-term periods continues to strengthen. As a result of our ongoing operational success, we have yet again raised our top and bottom-line guidance for both 2024 and 2025.” Mr. Grossman continued, “With this forecasted growth, we anticipate organically achieving a net leverage-neutral position in the fourth quarter of 2024, which would provide substantial balance sheet flexibility as we focus on maximizing stockholder value and lowering ADMA’s cost of capital. Throughout the third quarter, we advanced our intermediate-term growth initiatives, including enhancements to production yield processes and the successful production of a pilot-scale batch of our S. pneumoniae hyperimmune globulin pipeline program, SG-001. Additionally, we are pleased to announce the appointment of KPMG LLP (KPMG) as our new independent auditor effective as of today. We thank CohnReznick for their 17 years of service and look forward to this next chapter with KPMG. We believe ADMA is well-positioned to close 2024 on a high note and to sustain our rapid growth trajectory into 2025 and beyond.” Third Quarter 2024 Milestones and Objectives: Compounding Growth. Total revenue grew to $119.8 million, or 78% year-over-year. As a result, GAAP Net Income grew by 1,300% to $35.9 million and Adjusted EBITDA grew by 256% year-over-year to $45.4 million. The Company anticipates building on this momentum throughout the remainder of 2024 and into 2025.Favorably Evolving Mix Shift. The higher-margin product portfolio is expanding as a percentage of ADMA’s total revenue, with ASCENIV accounting for over 50% of the Company’s revenue. ADMA is actively taking steps to increase ASCENIV supply availability, which, if successful, could allow ASCENIV to become a significant majority of ADMA's total revenue in the future, driving further margin expansion and earnings growth.Strengthened Balance Sheet. Based on ADMA’s third quarter operating cash flow of $25.0 million and Adjusted EBITDA growth, the Company’s current net leverage ratio has organically improved to approximately 0.1x. The Company anticipates continued strengthening of the balance sheet driven by forecasted Adjusted EBITDA growth and ongoing cash generation in the fourth quarter of 2024 and beyond.Strengthened Governance. ADMA has successfully engaged and onboarded KPMG as its new independent registered public accounting firm. This auditor transition to a “Big 4” firm is a testament to the Company’s rapidly improving financial profile and market cap valuation.Added to the S&P SmallCap 600 Index. During the third quarter, ADMA joined the S&P SmallCap 600 Index. The Company expects this inclusion will increase its visibility within the investment community and the liquidity of its shares as it continues to execute on its top-tier growth strategy. The S&P SmallCap 600 Index is a stock market index established by Standard & Poor's that is designed to measure the performance of the small-cap segment of the market and is composed of 600 constituent companies in the U.S. equities market. The index is designed to track companies that meet specific inclusion criteria to ensure that they are liquid and financially viable. For more information on the S&P SmallCap 600 and S&P Dow Jones Indices, please visit www.spdji.com.Expanded ADMAlytics™ Implementation. ADMA successfully expanded implementation of ADMAlytics, the Company’s artificial intelligence and machine learning platform, to the commercial arm of the organization during the third quarter. When fully implemented, ADMAlytics is expected to further optimize the Company’s commercial growth strategy. Initiated in February 2024, the staggered implementation of ADMAlytics continues to yield impressive results across multiple areas of ADMA’s operations. These benefits include increased production efficiency, enhanced visibility into the 7–12-month manufacturing process, optimized commercial planning, streamlined plasma pooling, and reduced variability and FTE hours. These efficiencies are expected to further benefit ADMA’s rapid earnings growth outlook. Upwardly Revised 2024-2025 Financial Guidance: FY 2024 and 2025 total revenue is now expected to be more than $415 million and $465 million, respectively, increased from prior guidance of more than $400 million and $445 million, respectively.FY 2024 and 2025 GAAP net income is now expected to exceed $120 million and $165 million, respectively, increased from prior guidance of $105 million and $155 million, respectively.FY 2024 and 2025 Adjusted EBITDA is now expected to exceed $160 million and $215 million, respectively, increased from prior guidance of $150 million and $200 million, respectively. Advancing Innovative Growth Opportunities: Below are the Company’s ongoing R&D initiatives which, if successful, we believe represent the potential for upside to our current forecasted guidance: Biologic Production Yield Enhancement. During the third quarter and recent periods, commercial-scale production of ADMA's innovative biologics manufacturing process demonstrated a potential enhancement of yields by approximately 20% from the same starting plasma. If successful, we believe these yield improvements could significantly increase the Company’s peak financial targets, with potential revenue and earnings accretion expected to commence in the second half of 2025 and further inflect into 2026 and beyond.R&D Program - S. pneumoniae Hyperimmune Globulin, SG-001. ADMA has successfully completed production of a pilot-scale batch, and we have identified a prospective laboratory partner and are engaged in discussions for their services conducting animal model studies for our S. pneumoniae hyperimmune globulin program, SG-001. We expect to establish research protocols for forthcoming animal studies, with a focus on capital efficiency. Streptococcus pneumoniae, the leading cause of community-acquired pneumonia in the United States, affects one million adults annually, leading to 400,000 hospitalizations and a 5-7% mortality rate. Despite existing vaccines, vaccine-naive and immunocompromised individuals remain vulnerable. SG-001, if approved, could offer immediate antibody protection, potentially generating $300-500 million or more in high margin revenue annually. ADMA holds several U.S. and foreign patents covering its proprietary pneumococcal hyperimmune technology, including product preparation and usage for S. pneumoniae infections. ASCENIV Label Expansion: All pediatric patients in ASCENIV’s post-marketing pediatric study have now successfully completed their treatment schedule and the clinical trial database is on track to be locked in the fourth quarter of 2024. ADMA now anticipates filing its supplemental Biologics License Application (sBLA) over the coming quarters, with potential label-expanding approval in the first half of 2026. ASCENIV’s pediatric label expansion, if approved, may further strengthen ADMA’s product portfolio. Third Quarter 2024 Financial Results: Total revenues were $119.8 million for the quarter ended September 30, 2024, as compared to $67.3 million for the quarter ended September 30, 2023, an increase of $52.6 million, or approximately 78%. The increase is due to increased sales of ADMA’s immunoglobulin products, primarily ASCENIV, as well as an increase in third-party plasma sales by ADMA’s BioCenters business segment. Gross profits were $59.7 million for the quarter ended September 30, 2024, as compared to $24.7 million for the quarter ended September 30, 2023, an increase of $35.0 million. As a result, ADMA achieved a corporate gross margin of 50% in the third quarter of 2024 as compared to 37% in the third quarter of 2023. Third quarter 2024 corporate gross margins were adversely impacted due to an outsized sale of normal source plasma on the secondary spot market, which was recorded at a negative gross margin contribution. Adjusted EBITDA was $45.4 million for the quarter ended September 30, 2024, as compared to Adjusted EBITDA of $12.7 million for the quarter ended September 30, 2023, an increase of $32.6 million, or approximately 256%. GAAP net income was $35.9 million for the quarter ended September 30, 2024, compared to GAAP net Income of $2.6 million for the quarter ended September 30, 2023, an increase of 1,300%. As of September 30, 2024, ADMA had working capital of approximately $273.3 million, primarily consisting of $171.8 million of inventory, $86.7 million of cash and cash equivalents and $50.1 million of net accounts receivable, partially offset by current liabilities of $44.9 million. Conference Call Information To access the conference call, please dial (888) 596-4144 and refer to conference ID 2959956. It is recommended that you join approximately 10 minutes prior to the event start (although you may dial in at any time during the call). Attendees who will not be asking a question during the call are encouraged to listen in to the live webcast here. An archived replay of the event will be available located under “Events & Webcasts” in the investor section of the Company’s website at https://ir.admabiologics.com/events-webcasts. About ASCENIV™ ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the United States Food and Drug Administration (FDA) in April 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age). ASCENIV is manufactured using ADMA’s unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and respiratory syncytial virus (RSV) plasma obtained from donors tested using the Company’s proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body’s immune system to neutralize microbes such as bacteria and viruses that safeguard against infection and disease. ASCENIV is protected by numerous issued patents in the United States and internationally and a wide range of patent applications worldwide. Certain data and other information about ASCENIV can be found by visiting www.asceniv.com. Information about ADMA and its products can be found on the Company’s website at www.admabiologics.com. Additional Important Safety Information About ASCENIV™ WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILUREThrombosis may occur with immune globulin intravenous (IGIV) products, including ASCENIV. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients.Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ASCENIV does not contain sucrose.For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIV at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. ASCENIV™ Contraindications: History of anaphylactic or severe systemic reactions to human immunoglobulin. IgA deficient patients with antibodies to IgA and a history of hypersensitivity. ASCENIV™ Warnings and Precautions: IgA-deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have medications such as epinephrine available to treat any acute severe hypersensitivity reactions. [4, 5.1] Thrombotic events have occurred in patients receiving IGIV treatments. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for patients at risk of hyperviscosity. [5.2, 5.4] In patients at risk of developing acute renal failure. monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output. [5.3, 5.9] Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV treatment. Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments, especially with high doses or rapid infusion. [5.5] Hemolytic anemia can develop subsequent to IGIV treatment. Monitor patients for hemolysis and hemolytic anemia. [5.6] Monitor patients for pulmonary adverse reactions (Transfusion-related acute lung injury [TRALI]). If transfusion related acute lung injury is suspected, test the product and patient for antineutrophil antibodies. [5.7] Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. ASCENIV™ Adverse Reactions: The most common adverse reactions to ASCENIV (≥5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea To report SUSPECTED ADVERSE REACTIONS, contact ADMA Biologics at (800) 458-4244 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About ADMA Biologics, Inc. (ADMA) ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA)-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the United States, which provides its blood plasma for the manufacture of its products. ADMA’s mission is to manufacture, market and develop specialty biologics and human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA holds numerous U.S. and foreign patents related to and encompassing various aspects of its products and product candidates. For more information, please visit www.admabiologics.com. Use of Non-GAAP Financial Measures This press release includes certain non-GAAP financial measures that are not prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The Company believes Adjusted EBITDA is useful to investors in evaluating the Company’s financial performance. The Company uses Adjusted EBITDA as a key performance measure because we believe that it facilitates operating performance comparisons from period to period that exclude potential differences driven by the impact of variations of non-cash items such as depreciation and amortization, as well as stock-based compensation or certain non-recurring items. The Company believes that investors should have access to the same set of tools used by our management and board of directors to assess our operating performance. Adjusted EBITDA should not be considered as a measure of financial performance under GAAP, and the items excluded from Adjusted EBITDA are significant components in understanding and assessing the Company’s financial performance. Accordingly, this key business metric has limitations as an analytical tool. It should not be considered as an alternative to net income/loss or any other performance measures derived in accordance with GAAP and may be different from similarly titled non-GAAP measures used by other companies. Please refer to the tables below for the reconciliation of GAAP measures to non-GAAP measures for applicable periods. Cautionary Note Regarding Forward-Looking Statements This press release contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. (“we,” “our” or the “Company”). Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain such words as “confident,” “estimate,” “project,” “intend,” “prospective,” “forecast,” “target,” “anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “is likely,” “will likely,” “should,” “could,” “would,” “may,” “potential,” or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements include, but are not limited to, statements about the Company’s financial health, standing and future results of operations, including, but not limited to, total revenue, GAAP net income and Adjusted EBITDA guidance in future periods, and certain assumptions in connection therewith; timing to achieve a net leverage-neutral position; the market for ASCENIV, its supply availability, its potential impact on revenues, margin expansion and a mix shift towards ASCENIV; the benefits of joining the S&P SmallCap 600 Index; the appointment of KPMG as the Company’s new independent auditor; the utility of ADMAlytics and its impact on the Company’s earnings growth outlook; and additional growth opportunities, including but not limited to, the Company’s yield enhancement initiative and the timing related thereto, and SG-001, including the benefits thereof and revenue potential, and ASCENIV label expansion. Actual events or results may differ materially from those described in this press release due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto. INVESTOR RELATIONS CONTACT:Michelle Pappanastos Senior Managing Director, Argot Partners | 212-600-1902 | michelle@argotpartners.com ADMA BIOLOGICS, INC. AND SUBSIDIARIESCONSOLIDATED BALANCE SHEETS(Unaudited) September 30, December 31, 2024 2023 (Unaudited) (In thousands, except share data)ASSETS Current assets: Cash and cash equivalents$86,707 $51,352 Accounts receivable, net 50,140 27,421 Inventories 171,801 172,906 Prepaid expenses and other current assets 9,545 5,334 Total current assets 318,193 257,013 Property and equipment, net 53,694 53,835 Intangible assets, net 485 499 Goodwill 3,530 3,530 Right-to-use assets 8,897 9,635 Deposits and other assets 5,819 4,670 TOTAL ASSETS$390,618 $329,182 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable$16,020 $15,660 Accrued expenses and other current liabilities 27,535 32,919 Current portion of deferred revenue 143 182 Current portion of lease obligations 1,193 1,045 Total current liabilities 44,891 49,806 Senior notes payable, net of discount 101,326 130,594 Deferred revenue, net of current portion 1,583 1,690 End of term fee 1,688 1,688 Lease obligations, net of current portion 8,865 9,779 Other non-current liabilities 375 419 TOTAL LIABILITIES 158,728 193,976 COMMITMENTS AND CONTINGENCIES STOCKHOLDERS' EQUITY Preferred Stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued and outstanding - - Common Stock - voting, $0.0001 par value, 300,000,000 shares authorized, 236,378,607 and 226,063,032 shares issued and outstanding at September 30, 2024 and December 31, 2023 24 23 Additional paid-in capital 652,345 641,439 Accumulated deficit (420,479) (506,256)TOTAL STOCKHOLDERS' EQUITY 231,890 135,206 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY$390,618 $329,182 ADMA BIOLOGICS, INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited) Three Months ended September 30, Nine Months ended September 30, 2024 2023 2024 2023 (In thousands, except share and per share data) REVENUES $119,839 $67,275 $308,905 $184,311 Cost of product revenue 60,180 42,622 152,685 126,455 Gross profit 59,659 24,653 156,220 57,856 OPERATING EXPENSES: Research and development 412 596 1,422 2,854 Plasma center operating expenses 1,021 467 2,968 3,581 Amortization of intangible assets 28 179 363 537 Selling, general and administrative 18,560 14,726 50,807 43,485 Total operating expenses 20,021 15,968 55,560 50,457 INCOME (LOSS) FROM OPERATIONS 39,638 8,685 100,660 7,399 OTHER INCOME (EXPENSE): Interest income 666 423 1,499 1,005 Interest expense (3,499) (6,398) (11,051) (18,812)Other expense (56) (145) (107) (186)Other expense, net (2,889) (6,120) (9,659) (17,993) INCOME (LOSS) BEFORE INCOME TAXES 36,749 2,565 91,001 (10,594) Provision for income taxes 840 - 5,224 - NET INCOME (LOSS) $35,909 $2,565 $85,777 $(10,594) BASIC EARNINGS (LOSS) PER COMMON SHARE $0.15 $0.01 $0.37 $(0.05)DILUTED EARNINGS (LOSS) PER COMMON SHARE $0.15 $0.01 $0.35 $(0.05) WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: Basic 234,571,376 225,276,980 231,959,579 223,306,331 Diluted 244,804,065 233,761,262 241,772,162 223,306,331 NON-GAAP RECONCILIATIONRECONCILIATION OF GAAP NET INCOME (LOSS) TO ADJUSTED EBITDA Three Months ended September 30, Nine Months ended September 30, 2024 2023 2024 2023 (In thousands)Net income (loss)$35,909 $2,565 $85,777 $(10,594)Depreciation 1,912 1,913 5,738 5,686 Amortization 28 179 363 537 Income taxes 840 - 5,224 - Interest expense 3,499 6,398 11,051 18,812 EBITDA 42,188 11,055 108,153 14,441 Stock-based compensation 3,179 1,695 8,183 4,442 IT systems disruption - - 2,770 Adjusted EBITDA$45,367 $12,750 $116,336 $21,653