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 ...

Ifetroban demonstrated significant 5.4% improvement in cardiac function NASHVILLE, Tenn., March 19, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company with development efforts focused on rare diseases, today announced that results from its Phase 2 FIGHT DMD clinical trial were selected for a late-breaking presentation at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Dallas. The trial demonstrated significant cardiac benefit ...

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 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]

Company Announcement - Cumberland Pharmaceuticals Inc. will release its annual 2024 financial results and provide a company update on March 4, 2025, after market close [1] - A conference call is scheduled for March 4 at 4:30 p.m. Eastern Time to discuss the results, with registration required for participation [1][2] Company Overview - Cumberland Pharmaceuticals is a specialty pharmaceutical company focused on unique products that enhance patient care, particularly in 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] - Cumberland is also conducting Phase II clinical programs for its ifetroban product candidate, targeting conditions such as Systemic Sclerosis, cardiomyopathy associated with Duchenne Muscular Dystrophy, and Idiopathic Pulmonary Fibrosis [3]

Core Viewpoint - Cumberland Pharmaceuticals and SciClone Pharmaceuticals announced the NMPA approval of Vibativ® (telavancin) in China, enabling its launch in a significant market for treating pneumonia and serious skin infections [1][4]. Company Overview - Cumberland Pharmaceuticals is focused on developing and commercializing unique products to improve patient care, with a portfolio that includes six FDA-approved brands [15][16]. - SciClone Pharmaceuticals is a global biopharmaceutical company dedicated to innovative therapies for cancer and severe infections, emphasizing a strategic transformation towards differentiated product offerings [12][13]. Product Details - Vibativ is an FDA-approved injectable antibiotic effective against hospital-acquired and ventilator-associated pneumonia caused by multidrug-resistant Gram-positive bacteria, including MRSA [2][6]. - The drug is administered once daily and does not require therapeutic drug monitoring, which reduces healthcare professionals' exposure to patients [2][5]. - Vibativ has demonstrated consistent efficacy against difficult-to-treat bacteria over the past decade, maintaining its potency against multidrug-resistant strains [3][9]. Clinical Evidence - Studies involving over 24,000 clinical isolates show Vibativ's effectiveness against challenging Gram-positive infections, with higher cure rates compared to vancomycin [3][9]. - Recent research published in Antimicrobial Agents and Chemotherapy indicates that Vibativ is safe for use in children aged 2 to 17, with reduced exposure compared to adults [10]. Market Strategy - SciClone has secured exclusive rights to register, promote, and distribute Vibativ in China, leveraging its strong distribution network to maximize patient access [1][4]. - The companies plan to launch Vibativ in China later in 2025, aiming to address the needs of patients with serious infections [4].

Core Insights - Cumberland Pharmaceuticals Inc. released topline results from its Phase 2 FIGHT DMD trial evaluating ifetroban for Duchenne muscular dystrophy (DMD) heart disease, which is a leading cause of death in DMD patients [1][2] - If approved, ifetroban would be the first therapy specifically indicated for DMD-related heart disease, having received both Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA [3] Study Details - The trial enrolled 41 patients who received either low-dose ifetroban (150 mg per day), high-dose ifetroban (300 mg per day), or placebo [2] - The primary endpoint was an improvement in the heart's left ventricular ejection fractions (LVEF), a key indicator of heart function [2] Key Findings - High-dose ifetroban treatment resulted in an overall 3.3% improvement in LVEF, with the high-dose group showing a 1.8% increase compared to a 1.5% decline in the placebo group [5] - Compared to propensity-matched natural history controls, the high-dose treatment provided a significant 5.4% overall improvement in LVEF, while control patients experienced a 3.6% decline [5] - Both doses of ifetroban were well-tolerated, with no serious drug-related events reported [5] Market Reaction - Following the trial results, CPIX stock increased by 23.01%, reaching $2.62 [3]

Core Insights - Cumberland Pharmaceuticals Inc. announced positive top-line results from its Phase 2 FIGHT DMD trial, evaluating ifetroban for Duchenne muscular dystrophy (DMD) heart disease, marking a breakthrough as the first successful Phase 2 study targeting cardiac complications in DMD patients [1][4] Group 1: Study Overview - The FIGHT DMD trial is a 12-month, double-blind, randomized, placebo-controlled study involving 41 DMD patients, assessing the efficacy of ifetroban at low (150 mg/day) and high doses (300 mg/day) compared to a placebo [4] - The primary endpoint of the study was the improvement in left ventricular ejection fraction (LVEF) [4] Group 2: Key Findings - High dose ifetroban treatment resulted in an overall 3.3% improvement in LVEF, with the high dose group showing a 1.8% increase, while the placebo group experienced a 1.5% decline [6] - Compared to propensity matched natural history controls, the high dose treatment provided a significant 5.4% overall improvement in LVEF, as control patients experienced a 3.6% decline [6] - Both doses of ifetroban were well-tolerated, with no serious drug-related events reported [6] Group 3: Medical Significance - Ifetroban is a novel oral medication that blocks the thromboxane receptor, which is crucial in inflammation and fibrosis, and has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA [7] - If approved, ifetroban would be the first therapy specifically indicated for DMD-related heart disease, addressing a critical unmet medical need [7] Group 4: Future Steps - Cumberland Pharmaceuticals plans to conduct further data analysis and prepare a full study report for an end of Phase 2 meeting with the FDA to discuss the next steps for product development and commercialization [8]