Financial Performance - Cumberland Pharmaceuticals reported net revenues of $11.7 million for Q1 2025, representing a 38% increase compared to the same period last year[1]. - The company generated a net profit of $1.3 million and adjusted earnings of $2.4 million, equating to $0.16 per share[7]. - Total operating expenses for the quarter were $10.4 million, leading to a cash flow from operations of $3.9 million[1][7]. - Net revenues for the three months ended March 31, 2025, were $11,713,055, a 38.8% increase from $8,497,701 in the same period of 2024[29]. - Operating income for Q1 2025 was $1,291,947, compared to an operating loss of $(1,869,250) in Q1 2024[29]. - Net income attributable to common shareholders for Q1 2025 was $1,257,068, a significant recovery from a net loss of $(1,946,263) in Q1 2024[29]. - Earnings per share attributable to common shareholders was $0.08 for Q1 2025, compared to a loss of $(0.14) in Q1 2024[29]. - Cash flows from operating activities provided $3,898,517 in Q1 2025, contrasting with cash used of $(2,136,647) in Q1 2024[31]. - Adjusted earnings for Q1 2025 were $2,397,743, with adjusted diluted earnings per share of $0.16, compared to adjusted loss of $(639,811) and $(0.05) per share in Q1 2024[33]. Assets and Liabilities - Cumberland ended the quarter with approximately $70 million in total assets, $41.6 million in liabilities, and $28.7 million in shareholders' equity[2][8]. - Total shareholders' equity increased to $28.7 million as of March 31, 2025, up from $22.9 million at the end of 2024[8][27]. - The company reported a net cash decrease of $(2,855,771) in cash and cash equivalents for Q1 2025, down from $18,321,624 at the beginning of the period[31]. Product Development and Regulatory Approvals - The Phase II study of ifetroban for Duchenne muscular dystrophy (DMD) yielded positive top-line results, marking a significant breakthrough for patients[3]. - Vibativ received regulatory approval in China, allowing Cumberland to enter the world's second-largest pharmaceutical market, with a product launch expected by year-end[6]. - The company plans to conduct further data analysis and prepare for an end-of-Phase-II meeting with the FDA regarding the DMD program[5]. - Cumberland's product portfolio includes Kristalose ($3.5 million), Sancuso ($2.3 million), Vibativ ($1.4 million), and Caldolor ($1.3 million) in Q1 2025[7]. Future Outlook - The company is optimistic about future growth driven by strong performance from approved brands and potential strategic acquisitions[3]. - The company made a net investment of $(1,162,357) in a manufacturing facility during Q1 2025[31]. - Proceeds from an ATM offering in Q1 2025 amounted to $5,266,334, contributing to financing activities[31]. - The weighted-average shares outstanding for diluted earnings in Q1 2025 were 15,259,824, compared to 14,098,022 in Q1 2024[33].

Financial Data and Key Metrics Changes - The company reported combined revenues of $11,700,000 for Q1 2025, representing a 38% increase compared to the prior year period [8][26] - Total assets improved to $70,000,000, with $50,000,000 in cash, and total liabilities decreased to $42,000,000, resulting in shareholders' equity of $51,000,000 [8][29] - Net profit for the quarter was $1,260,000, with adjusted earnings of $2,400,000 and cash flow from operations of $3,900,000 [8][26] Business Line Data and Key Metrics Changes - Revenue breakdown for Q1 2025 included $3,500,000 for Cristalos, $2,300,000 for SANKUSO, $1,400,000 for Vibativ, and $1,300,000 for Caldolor [26] - The company launched new marketing initiatives and expanded its sales force to support its FDA approved products [11][12] Market Data and Key Metrics Changes - The approval of Vibativ in China provides access to a significant pharmaceutical market, with expectations for launch later in the year [10] - The company is enhancing its presence in states with Medicaid coverage for Cristalos, contributing to its growth [14] Company Strategy and Development Direction - The company is focused on expanding its portfolio through strategic acquisitions and enhancing its marketing initiatives for existing products [32] - The management is optimistic about the positioning of Vibativ amid growing global concerns over antimicrobial resistance [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future, citing strong performance in Q1 and positive developments in the clinical pipeline [7][31] - The company anticipates continued momentum across its approved brands and further progress in its clinical pipeline [33] Other Important Information - The company continues to hold over $53,000,000 in tax net operating loss carryforwards, primarily from prior stock option exercises [29] - The company is implementing new trading plans for board members to increase their holdings in the company [29] Q&A Session Summary - There were no questions from participants during the Q&A session, and management encouraged private discussions with shareholders if desired [35][36]

Company Update - Cumberland Pharmaceuticals Inc. will release its first quarter 2025 financial results and provide a company update on May 6, 2025, after market close [1] - A conference call is scheduled for May 6 at 4:30 p.m. Eastern Time to discuss the results and updates [1] Company Overview - Cumberland Pharmaceuticals is a specialty pharmaceutical company focused on developing, acquiring, and commercializing products for hospital acute care, gastroenterology, and oncology market segments [3] - The company has a portfolio of FDA-approved brands, including Acetadote®, Caldolor®, Kristalose®, Sancuso®, Vaprisol®, and Vibativ® [5] Clinical Programs - The company is conducting Phase II clinical programs evaluating its ifetroban product candidate for conditions such as Systemic Sclerosis, cardiomyopathy associated with Duchenne Muscular Dystrophy, and Idiopathic Pulmonary Fibrosis [3]

Corporate Presentation Nasdaq CPIX Safe Harbor Statement This presentation contains forward-looking statements concerning our approved products and product development, our technology, our competitors, our intellectual property, our financial condition and our plans for research and development programs that involve risks, uncertainties and assumptions. These statements are based on the current estimates and assumptions of the management of Cumberland Pharmaceuticals as of the date of this presentation and ...

Core Insights - Cumberland Pharmaceuticals announced significant results from its Phase 2 FIGHT DMD clinical trial, demonstrating a 5.4% improvement in cardiac function for patients with Duchenne muscular dystrophy (DMD) [1][3][4] Group 1: Clinical Trial Results - The Phase 2 FIGHT DMD trial showed that high-dose ifetroban treatment resulted in a 3.3% improvement in left ventricular ejection fraction (LVEF) compared to placebo [3] - When compared to propensity-matched natural history controls, high-dose treatment provided a significant 5.4% overall improvement in LVEF, while control patients experienced a 3.6% decline [3] - These improvements in cardiac function could lead to enhanced quality of life and survival for DMD patients [3] Group 2: Drug Information - Ifetroban is an oral thromboxane receptor antagonist that has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for DMD-related heart disease [4][7][8] - If approved, ifetroban would be the first therapy specifically indicated for DMD-related heart disease [8] Group 3: Company and Industry Context - Cumberland Pharmaceuticals is focused on developing treatments for rare diseases, with a growing portfolio of patents related to ifetroban for DMD [5][11] - The company is preparing for an end-of-Phase-2 meeting with the FDA to discuss the next steps for ifetroban's development and commercialization [5] - Current therapies for DMD primarily focus on preserving muscle function, highlighting the urgent need for treatments addressing cardiac complications [4][6]

Product Development and Approvals - Acetadote received FDA approval for a simplified dosing regimen in 2024, which reduces medication errors and non-allergic reactions without compromising effectiveness[28]. - Caldolor is the only non-opioid product approved to treat pain in infants delivered through injection, with expanded labeling for use in infants aged 3 to 6 months approved in 2023[40]. - A clinical study involving 150,000 patients showed that Caldolor is associated with a significantly reduced incidence of adverse drug reactions compared to its key competitor, ketorolac[43]. - Kristalose, a prescription laxative, is the only product available in pre-measured powder packets, with 77% of patients preferring its taste and consistency over syrup forms[45]. - Cumberland acquired U.S. assets and rights to Sancuso in January 2022, an FDA-approved oncology supportive care medicine[50]. - Sancuso is the first FDA-approved prescription patch for preventing chemotherapy-induced nausea and vomiting, effective for up to five consecutive days[51]. - Cumberland acquired Vaprisol, the only intravenously administered branded treatment for hyponatremia, which is common among hospitalized patients[53]. - Cumberland introduced Vibativ, an FDA-approved injectable anti-infective, in early 2021, targeting serious infections caused by drug-resistant bacteria[56]. - The company is developing a pipeline of new product candidates, including ifetroban for various serious conditions, with significant potential for orphan diseases[75]. - The company secured pediatric approval for Acetadote and Caldolor, expanding their labeling and usage[79]. - Ifetroban is undergoing Phase II studies for systemic sclerosis and idiopathic pulmonary fibrosis, with investigational new study applications cleared by the FDA[122]. - The FDA has approved a new manufacturing facility for Vaprisol, with plans to relaunch the brand once the FDA clears the submission for manufacturing[139]. - A new smaller package for Vibativ was launched in 2024 to better serve smaller hospitals and infusion centers, enhancing cost management and workflow[140]. Financial Performance and Strategy - In 2024, the company reported that Customer 1 accounted for 29%, Customer 2 for 26%, and Customer 3 for 21% of consolidated gross revenues[82]. - The company maintains financial discipline by managing expenses in line with revenues to ensure positive cash flow from operations[79]. - The company aims to acquire under-promoted, FDA-approved drugs and late-stage development products to enhance its portfolio, exemplified by the acquisitions of Vibativ and Sancuso[79]. - Cumberland's growth strategy includes maximizing existing brands and building international partnerships for product distribution[76]. Partnerships and Collaborations - The company has established partnerships with Poly Pharmaceuticals and Foxland Pharmaceuticals to expand the marketing reach of Kristalose[47]. - The company continues to build a network of international partners to register and provide its medicines globally[12]. - The company entered into a Development Agreement with Octapharma AG for a new product designed to locate sites of internal bleeding, with funding and milestone payments provided by Octapharma[108]. - The company is actively pursuing international partnerships to support product registration and commercialization, including agreements with D.B. Pharm and WinHealth[83][89]. Market Competition and Intellectual Property - The company faces competition in the acetaminophen overdose market from companies selling orally administered NAC, including InnoPharma, which has a generic version of Acetadote[178]. - The company is aware of various product candidates in development to treat acute pain, which may compete with Caldolor, including injectable NSAIDs and novel opioids[181]. - Kristalose competes in the constipation therapy market, which includes various prescription and OTC products[184]. - The company emphasizes the importance of brand awareness, intellectual property rights, and successful business development activities in maintaining its competitive position[176]. - The company holds multiple patents for Caldolor, with the latest patent (the 400 Caldolor Patent) issued on November 7, 2023, scheduled to expire in March 2032[172]. - The company acquired numerous U.S. patents for Vibativ in November 2018, with the 623 Vibativ Patent scheduled to expire in January 2027[174]. - The company has multiple granted patents relating to its ifetroban products and pending patent applications with the USPTO[175]. Corporate Social Responsibility and Employee Engagement - The company reported that women represented 49% of its workforce and 27% were minorities, highlighting its commitment to employee development and recognition[19]. - The company is committed to sustainability, as evidenced by its inaugural Sustainability Report issued in 2019 and ongoing initiatives[17]. - The Cumberland Pharma Foundation was established to support ongoing philanthropic endeavors, with an initial grant of 50,000 shares of common stock provided to address financial needs[129].

Financial Data and Key Metrics Changes - For Q4 2024, net revenue from continuing operations was $10.4 million, representing an 11.6% increase over the prior year period [43][44] - Full year 2024 net revenue totaled $38 million, with a net loss of approximately $6.5 million for the year [45][46] - Total operating expenses for Q4 were $12.3 million, down from $15.5 million in the prior year [45] Business Line Data and Key Metrics Changes - Net revenue by product for Q4 2024 included $4.4 million for Kristalose, $2.4 million for Sancuso, $2.1 million for Vibativ, and $1.4 million for Caldolor [44] - Full year product revenue totaled $15.3 million for Kristalose, $9 million for Sancuso, $6.9 million for Vibativ, and $5 million for Caldolor [45] Market Data and Key Metrics Changes - Vibativ received approval in China, expanding its international business, and shipments began to Saudi Arabia [14] - Kristalose saw increased coverage in Medicaid plans in Virginia, Louisiana, and Maine, contributing to its growth [23] Company Strategy and Development Direction - The company aims to acquire and commercialize a portfolio of branded pharmaceuticals while expanding its sales organization and development pipeline [11] - Cumberland Emerging Technologies (CET) division collaborates with Vanderbilt University to enhance its development pipeline [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress of clinical studies for ifetroban and its potential to benefit many patients [54] - The company expects double-digit revenue growth and positive cash flow from operations in the upcoming year [57] Other Important Information - The company repurchased a total of 339,000 shares through the end of December 2024 [52] - Cumberland holds $53 million in tax net operating loss carryforwards, primarily from prior stock option exercises [53] Q&A Session Summary Question: Are there any updates on the company's acquisition initiatives? - The company is actively seeking additional FDA-approved brands that complement its portfolio and can be integrated into its infrastructure [56] Question: What are the expectations for revenue growth in 2025? - The company anticipates double-digit revenue growth and positive cash flow from operations in 2025 [57]

Financial Data and Key Metrics Changes - For Q4 2024, net revenue from continuing operations was $10.4 million, representing an 11.6% increase over the prior year period [43][44] - Full year 2024 net revenue totaled $38 million, with a net loss of approximately $6.5 million for the year [45][46] - Total operating expenses for Q4 were $12.3 million, down from $15.5 million in the prior year [45] Business Line Data and Key Metrics Changes - Net revenue by product for Q4 2024 included $4.4 million for Kristalose, $2.4 million for Sancuso, $2.1 million for Vibativ, and $1.4 million for Caldolor [44] - Full year product revenue totaled $15.3 million for Kristalose, $9 million for Sancuso, $6.9 million for Vibativ, and $5 million for Caldolor [45] Market Data and Key Metrics Changes - Vibativ received approval in China, expanding its international business, and shipments began to Saudi Arabia [14] - Kristalose saw growth due to new Medicaid coverage in several states, including Virginia, Louisiana, and Maine [23] Company Strategy and Development Direction - The company aims to acquire and commercialize a portfolio of branded pharmaceuticals while expanding its sales organization and development pipeline [11][12] - Cumberland Emerging Technologies (CET) is a joint initiative with Vanderbilt University to enhance the development pipeline [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress of clinical studies for ifetroban and its potential to benefit many patients [54] - The company expects double-digit revenue growth and positive cash flow from operations in the upcoming year [57] Other Important Information - The company continues to hold $53 million in tax net operating loss carryforwards, primarily from prior stock option exercises [52] - Cumberland has an active acquisition initiative to seek additional FDA-approved brands [56] Q&A Session Summary - No questions were raised during the Q&A session, and management encouraged private discussions with shareholders if desired [60]

Financial Performance - Cumberland Pharmaceuticals reported fourth quarter 2024 net revenues of $10.4 million, an 11.6% increase compared to the prior year period[2]. - Full year 2024 net revenues totaled $38 million, with contributions of $15.3 million from Kristalose, $9 million from Sancuso, $7.2 million from Vibativ, and $5 million from Caldolor[11]. - Cumberland's net loss for the fourth quarter of 2024 was approximately $1.9 million, with a total net loss of approximately $6.4 million for the year[11]. - Net revenues for Q4 2024 were $10,435,569, an increase of 11.6% compared to $9,353,066 in Q4 2023[33]. - The company reported a net loss of $6,443,715 for the year 2024, compared to a net loss of $6,330,766 in 2023, indicating a slight increase in losses[35]. - Basic loss per share for Q4 2024 was $(0.14), compared to $(0.44) in Q4 2023[33]. Assets and Liabilities - The company ended 2024 with total assets of $76 million, including $18 million in cash and cash equivalents, and total liabilities of $53 million[3][13]. - Total assets decreased to $75,583,410 in 2024 from $81,776,075 in 2023, representing a decline of 7.6%[31]. - Total current liabilities increased to $31,621,729 in 2024 from $27,982,249 in 2023, reflecting a rise of 13.8%[31]. - The company reported a total shareholders' equity of $22,853,494 in 2024, down from $29,603,441 in 2023, a decline of 22.9%[31]. Operating Expenses - Cumberland's total operating expenses for 2024 were $44 million, with an adjusted loss of $1.0 million for the year[11][12]. - The company incurred total costs and expenses of $44,300,354 in 2024, down from $49,107,168 in 2023, a reduction of 9.4%[33]. - Operating loss for Q4 2024 was $1,842,039, an improvement from the operating loss of $6,179,239 in Q4 2023[33]. - Research and development expenses for the year 2024 were $4,816,206, down from $5,834,229 in 2023, a decrease of 17.4%[33]. Regulatory and Clinical Developments - The FDA granted Orphan Drug and Rare Pediatric Disease designations for ifetroban, aimed at treating cardiomyopathy in Duchenne muscular dystrophy[4]. - Cumberland announced positive top-line results from its Phase II study of ifetroban, marking a breakthrough for patients with cardiac complications related to Duchenne muscular dystrophy[5]. - Vibativ received regulatory approval in China, expanding Cumberland's international business presence[5]. - The company is advancing multiple Phase II clinical trials for ifetroban, addressing unmet medical needs in significant market segments[10]. Supplemental Financial Measures - The Company utilizes adjusted supplemental financial measures to evaluate its operating performance, which are considered "non-GAAP" financial measures[38]. - Adjusted Earnings are defined as net loss adjusted for income taxes, depreciation and amortization expense, share-based compensation, interest income, and interest expense[41]. - Adjusted Diluted Earnings Per Share is calculated by dividing the adjusted loss by diluted weighted-average common shares outstanding[41]. - The supplemental financial measures provide useful information about the Company's underlying performance across reporting periods[40]. - Certain items excluded from the supplemental measures include depreciation, amortization, share-based compensation expense, and income taxes[40]. - The Company believes these measures reflect long-term strategic activities and core business performance[40]. - Management views these supplemental measures as important for evaluating the Company's operating results[40]. - Management encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety for a complete understanding of financial performance[39]. - The financial information for the year ended December 31, 2023, has been adjusted to align with the current year presentation[41].

Core Insights - Cumberland Pharmaceuticals Inc. reported a net revenue of $10.4 million for Q4 2024, marking an 11.6% increase year-over-year, with total annual revenues reaching $38 million [1][9] - The company ended 2024 with total assets of $76 million, including $18 million in cash and $53 million in liabilities [2][12] - CEO A.J. Kazimi highlighted 2024 as a transformative year with expanded product labeling, key FDA designations, and new study publications [3] Financial Performance - For the full year 2024, net revenues were $38 million, with significant contributions from Kristalose® ($15.3 million), Sancuso® ($9 million), Vibativ® ($7.2 million), and Caldolor® ($5 million) [9] - Total operating expenses for 2024 were $44 million, resulting in a net loss of approximately $6.4 million for the year [9][11] - The adjusted loss for the year was $1 million, excluding certain costs related to product acquisitions [11] Product Developments - The FDA granted Orphan Drug and Rare Pediatric Disease designations for ifetroban, aimed at treating cardiomyopathy in Duchenne muscular dystrophy [3] - New research published demonstrated Caldolor's safety and healthcare resource advantages over ketorolac in both adult and pediatric populations [4] - A simplified dosing regimen for Acetadote® was approved by the FDA, enhancing the efficiency of administration [6] Clinical Trials and Studies - Cumberland made significant progress in Phase II clinical trials for ifetroban, closing studies in Duchenne muscular dystrophy and nearing completion in systemic sclerosis and pulmonary fibrosis [8] - The company provided 3.9 million doses of FDA-approved products to patients in 2024 and reported no product recalls [7] Market Expansion - Vibativ® received approval in China, expanding Cumberland's international business, alongside shipments to Saudi Arabia [10]