WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . UNITED STATES SECURITIES AND EXCHANGE COMMISSION Commission file number: 001-33637 Cumberland Pharmaceuticals Inc. (Exact Name of Registrant as Specified In Its Charter) Tennessee 62-1765329 (State or Oth ...

Cumberland Pharmaceuticals Inc (CPIX) Q1 2025 Earnings Call May 06, 2025 04:30 PM ET Company Participants Molly Aggas - Account SupervisorA.J. Kazimi - Founder, Chairman & CEOTodd Anthony - Vice President of Organizational DevelopmentJohn Hamm - VP & CFO Operator Good afternoon, and welcome to the Cumberland Pharmaceuticals first quarter twenty twenty five financial report and company update. This call is being recorded at the company's request and will be archived on its website for one year from today's d ...

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].

Cumberland Pharmaceuticals Inc (CPIX) Q1 2025 Earnings Call May 06, 2025 04:30 PM ET Speaker0 Good afternoon, and welcome to the Cumberland Pharmaceuticals first quarter twenty twenty five financial report and company update. This call is being recorded at the company's request and will be archived on its website for one year from today's date. I would now like to turn the call over to Molly Agus, account supervisor at the Dalton agency who handles Cumberland's communications. Molly, please proceed. Speaker ...

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 ...

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]

Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) Q4 2024 Earnings Conference Call March 4, 2025 4:30 PM ET Company Participants Molly Aggas – Account Supervisor-Dalton Agency A.J. Kazimi – Chief Executive Officer Todd Anthony – Vice President-Organizational Development John Hamm – Chief Financial Officer Conference Call Participants Operator Good afternoon, and welcome to Cumberland Pharmaceuticals Fourth Quarter 2024 Financial Report and Company Update. This call is being recorded at company’s request and wil ...