Cumberland Pharmaceuticals(CPIX) - 2025 Q2 - Quarterly Results

Executive Summary & Financial Highlights Q2 & YTD Financial Performance Cumberland Pharmaceuticals reported a 10% increase in net revenues for Q2 2025, reaching $10.8 million, and a 23% increase year-to-date for the first six months of 2025, totaling $22.6 million Net Revenues Summary | Metric | Q2 2025 Revenue | YTD 2025 Revenue | YoY Change (Q2) | YoY Change (YTD) | | :----- | :-------------- | :--------------- | :-------------- | :--------------- | | Net Revenues | $10.8 million | $22.6 million | +10% | +23% | Balance Sheet Snapshot As of the end of Q2 2025, Cumberland Pharmaceuticals held approximately $68 million in total assets, $40 million in liabilities, and $28 million in shareholders' equity Balance Sheet Overview | Metric | Amount (June 30, 2025) | | :----- | :--------------------- | | Total Assets | ~$68 million | | Total Liabilities | ~$40 million | | Shareholders' Equity | $28 million | CEO Commentary CEO A.J. Kazimi highlighted a strong first half of the year, attributing success to clinical development program progress, and expressed optimism for continued growth in providing unique patient care products - CEO A.J. Kazimi noted a strong first half, driven by clinical development progress, and aims to continue providing unique products to improve patient care[3] Recent Company Developments Vibativ Product Updates Cumberland announced the availability of the Vibativ 4-Vial Starter Pak to Vizient providers, expanding access to over 65% of the nation's acute care providers. Additionally, a new pharmacokinetic analysis published in June 2025 reinforced optimized dosing strategies for Vibativ - Vibativ 4-Vial Starter Pak is now available to Vizient Inc. healthcare providers nationwide, serving over 65% of acute care providers[4][5] - A comprehensive pharmacokinetic analysis of Vibativ, published in June 2025, supports optimized dosing strategies for various infection severities and renal functions[6] Ifetroban Clinical Program Cumberland's ifetroban candidate showed promising results in Phase II trials for Duchenne muscular dystrophy (DMD), with a 5.4% improvement in cardiac function. The company completed analysis and submitted results to the FDA. Enrollment for Systemic Sclerosis is complete, and the FIGHTING FIBROSIS™ trial for Idiopathic Pulmonary Fibrosis is underway Duchenne Muscular Dystrophy (DMD) Trial Breakthrough findings from the Phase II FIGHT DMD trial for ifetroban demonstrated a 5.4% improvement in cardiac function and reduced cardiac damage in DMD patients. The clinical study report was submitted to the FDA in June 2025, requesting an end-of-Phase II meeting - Phase II FIGHT DMD trial for ifetroban showed a 5.4% improvement in cardiac function and reduced cardiac damage in Duchenne muscular dystrophy patients[7] - Cumberland completed the comprehensive analysis of FIGHT DMD study results and submitted the clinical study report to the FDA in June 2025, requesting an end-of-Phase II meeting[8] Systemic Sclerosis Study Enrollment for the Phase II clinical program evaluating ifetroban in patients with Systemic Sclerosis was completed this year, and the company is preparing to evaluate results - Enrollment for the Phase II ifetroban clinical program in Systemic Sclerosis patients was completed this year, with results evaluation pending[9] Idiopathic Pulmonary Fibrosis (IPF) Trial The Phase II FIGHTING FIBROSIS™ trial for ifetroban in Idiopathic Pulmonary Fibrosis patients is actively enrolling patients across U.S. medical centers, including plans for interim safety and efficacy analyses - The Phase II FIGHTING FIBROSIS™ trial for ifetroban in Idiopathic Pulmonary Fibrosis is actively enrolling patients in the U.S., with planned interim safety and efficacy analyses[10] Caldolor Study Publication A study on Caldolor (intravenous ibuprofen) was published in May 2025, demonstrating its safety and efficacy for managing post-operative pain in older patients (60+ years), a vulnerable population where traditional pain management carries increased risks - A study published in May 2025 confirmed Caldolor's safety and efficacy for post-operative pain management in older patients (60+), a population with increased risks from traditional pain options[11] Detailed Financial Results Net Revenue Breakdown For Q2 2025, net revenues totaled $10.8 million, with Kristalose, Sancuso, and Vibativ being the top contributors. Year-to-date net revenues reached $22.6 million, with Kristalose leading product sales Product Net Revenue Breakdown | Product | Q2 2025 Net Revenue | YTD 2025 Net Revenue | | :-------- | :------------------ | :------------------- | | Kristalose | $2.8 million | $6.2 million | | Sancuso | $3.1 million | $5.4 million | | Vibativ | $2.7 million | $4.1 million | | Caldolor | $1.6 million | $2.9 million | | Total Net Revenues | $10.8 million | $22.6 million | Operating Expenses Total operating expenses for Q2 2025 were $11.6 million, and for the first half of the year, they amounted to $22 million Operating Expenses Summary | Metric | Q2 2025 | YTD 2025 | | :--------------- | :---------- | :--------- | | Total Operating Expenses | $11.6 million | $22 million | Net Income (Loss) & Adjusted Earnings Cumberland reported a net loss of approximately $741,000 for Q2 2025, but a year-to-date net income of approximately $516,000. Adjusted earnings for the first six months of 2025 were $2.8 million, or $0.18 per diluted share Net Income and Adjusted Earnings Summary | Metric | Q2 2025 | YTD 2025 | | :--------------------- | :------------ | :----------- | | Net Income (Loss) | ($741,000) loss | ~$516,000 income | | Adjusted Earnings (YTD) | N/A | $2.8 million | | Adjusted EPS (Diluted, YTD) | N/A | $0.18 | Balance Sheet Summary As of June 30, 2025, the company's balance sheet showed total assets of approximately $68 million, including $16 million in cash and cash equivalents. Total liabilities were $40 million, with $5 million on the credit facility, and total shareholders' equity stood at $28 million Balance Sheet Details | Metric (as of June 30, 2025) | Amount | | :--------------------------- | :----------- | | Total Assets | ~$68 million | | Cash and Cash Equivalents | ~$16 million | | Total Liabilities | ~$40 million | | Credit Facility | ~$5 million | | Total Shareholders' Equity | ~$28 million | Earnings Call Information Cumberland Pharmaceuticals will host a conference call on August 5, 2025, at 4:30 p.m. Eastern Time to discuss financial results and provide a company update. Registration and replay information are available - A conference call to discuss financial results and company updates was scheduled for August 5, 2025, at 4:30 p.m. Eastern Time, with replay available for one year[15][16] About Cumberland Pharmaceuticals Company Overview Cumberland Pharmaceuticals Inc. is a Tennessee-based biopharmaceutical company focused on developing, acquiring, and commercializing unique products for hospital acute care, gastroenterology, and oncology markets. It also has Phase II clinical programs for ifetroban in DMD, Systemic Sclerosis, and Pulmonary Fibrosis - Cumberland Pharmaceuticals is a Tennessee-based biopharmaceutical company focused on hospital acute care, gastroenterology, and oncology markets[17] - The company is developing its ifetroban product candidate through Phase II clinical programs for Duchenne Muscular Dystrophy, Systemic Sclerosis, and Pulmonary Fibrosis[17] Product Portfolio Details Cumberland's portfolio includes six FDA-approved brands: Acetadote for acetaminophen poisoning, Caldolor for pain and fever, Kristalose for constipation, Sancuso for chemotherapy-induced nausea and vomiting, Vaprisol for hyponatremia, and Vibativ for serious bacterial infections Acetadote (acetylcysteine) Injection Acetadote is an intravenous treatment indicated to prevent or lessen hepatic injury from acetaminophen overdose, approved for emergency department use. It is contraindicated in patients with hypersensitivity to its components - Acetadote is an FDA-approved intravenous injection for preventing or lessening hepatic injury from acetaminophen poisoning, administered within 8-10 hours post-ingestion[19][22] Caldolor (ibuprofen) Injection Caldolor is the first FDA-approved intravenous therapy for fever, also indicated for mild to moderate pain and as an adjunct to opioids for moderate to severe pain in adults and pediatric patients. It is contraindicated in patients with NSAID hypersensitivity or during peri-operative CABG surgery - Caldolor is the first FDA-approved intravenous therapy for fever, also indicated for mild to moderate pain and as an opioid adjunct for severe pain in adults and pediatric patients[20][22] - Caldolor is contraindicated in patients with known hypersensitivity to NSAIDs or during the peri-operative period of coronary artery bypass graft (CABG) surgery[21] Kristalose (lactulose) Oral Solution Kristalose is a unique, proprietary crystalline form of lactulose indicated for acute and chronic constipation, with no restrictions on therapy length or patient age. It is contraindicated for patients requiring a low-galactose diet - Kristalose is a unique, proprietary crystalline lactulose oral solution for acute and chronic constipation, with no age or therapy length restrictions[22][23] Sancuso (granisetron) Transdermal System Sancuso is the only FDA-approved skin patch for preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately/highly emetogenic chemotherapy, providing continuous release for up to five consecutive days - Sancuso is the only FDA-approved skin patch for preventing chemotherapy-induced nausea and vomiting (CINV) for up to five consecutive days of chemotherapy[22][24] Vaprisol (conivaptan hydrochloride) Injection Vaprisol is an intravenous treatment for hyponatremia in critical care settings, acting as a vasopressin receptor antagonist to raise serum sodium levels. It is contraindicated in hypovolemic hyponatremia and with potent CYP3A inhibitors - Vaprisol is an intravenous treatment for hyponatremia in critical care, raising serum sodium levels by acting as a vasopressin receptor antagonist[22][25] - Vaprisol is contraindicated in patients with hypovolemic hyponatremia and with coadministration of potent CYP3A inhibitors[25] Vibativ (telavancin) for Injection Vibativ is an FDA-approved injectable anti-infective for serious bacterial infections, including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin structure infections, targeting difficult-to-treat Gram-positive pathogens. It is contraindicated with intravenous unfractionated heparin sodium and in patients with known hypersensitivity to telavancin - Vibativ is an FDA-approved injectable anti-infective for serious Gram-positive bacterial infections, including hospital-acquired pneumonia and complicated skin infections[22][26] - Vibativ is contraindicated with intravenous unfractionated heparin sodium and in patients with known hypersensitivity to telavancin[26] About Cumberland Emerging Technologies Cumberland Emerging Technologies (CET) is a joint initiative with Vanderbilt University, LaunchTN, and WinHealth, focused on advancing biomedical technologies from regional research centers to the marketplace. CET provides expertise in intellectual property, regulatory, manufacturing, and marketing, and offers laboratory space for early-stage life sciences ventures - Cumberland Emerging Technologies (CET) is a joint initiative with Vanderbilt University, LaunchTN, and WinHealth, aiming to advance biomedical technologies from regional research centers to the market[27] - CET offers expertise in intellectual property, regulatory, manufacturing, and marketing, and provides laboratory space for early-stage life sciences ventures[28] Forward-Looking Statements This section contains forward-looking statements reflecting Cumberland's current views on future events, subject to various risks including macroeconomic conditions, competition, manufacturing issues, and regulatory compliance. Readers are cautioned not to place undue reliance on these statements, and the company does not undertake to revise them publicly - The press release contains forward-looking statements based on current views and assumptions, subject to risks like macroeconomic conditions, competition, manufacturing, and regulatory compliance[29] - Readers are cautioned not to place undue reliance on forward-looking statements, and the company disclaims any obligation to publicly revise them[29] Financial Statements Condensed Consolidated Balance Sheets The condensed consolidated balance sheets show a decrease in total assets from $75.6 million at December 31, 2024, to $67.9 million at June 30, 2025. Cash and cash equivalents also decreased, while shareholders' equity increased from $22.9 million to $28.0 million over the same period Consolidated Balance Sheet | Metric | June 30, 2025 | December 31, 2024 | Change | | :--------------------- | :-------------- | :---------------- | :----- | | Total Assets | $67,907,149 | $75,583,410 | -$7,676,261 | | Cash and cash equivalents | $16,087,281 | $17,964,184 | -$1,876,903 | | Total Liabilities | $40,228,222 | $53,037,433 | -$12,809,211 | | Total Shareholders' Equity | $27,989,795 | $22,853,494 | +$5,136,301 | Condensed Consolidated Statements of Operations For the six months ended June 30, 2025, net revenues increased to $22.55 million from $18.35 million in the prior year. The company reported a net income of $512,977 for YTD 2025, a significant improvement from a net loss of $3.01 million in YTD 2024. Diluted EPS for YTD 2025 was $0.03, up from -$0.21 in YTD 2024 Consolidated Statements of Operations | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :----------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net revenues | $10,837,363 | $9,848,849 | $22,550,418 | $18,346,550 | | Total costs and expenses | $11,584,841 | $10,875,537 | $22,005,949 | $21,242,488 | | Operating income (loss) | $(747,478) | $(1,026,688) | $544,469 | $(2,895,938) | | Net income (loss) attributable to common shareholders | $(740,740) | $(1,085,612) | $516,328 | $(3,031,875) | | Diluted EPS | $(0.05) | $(0.08) | $0.03 | $(0.21) | Condensed Consolidated Statements of Cash Flows For the six months ended June 30, 2025, net cash provided by operating activities was $4.74 million, a significant improvement from a net cash used of $2.99 million in the prior year. Net cash used in investing activities increased to $942,322, and net cash used in financing activities was $5.68 million, primarily due to payments on the line of credit Consolidated Statements of Cash Flows | Metric (6 Months Ended June 30) | 2025 | 2024 | Change | | :-------------------------------- | :----------- | :----------- | :----------- | | Net cash provided by (used in) operating activities | $4,742,318 | $(2,992,307) | +$7,734,625 | | Net cash used in investing activities | $(942,322) | $(104,990) | -$837,332 | | Net cash (used in) provided by financing activities | $(5,676,899) | $2,112,119 | -$7,789,018 | | Net decrease in cash and cash equivalents | $(1,876,903) | $(985,178) | -$891,725 | | Cash and cash equivalents at end of period | $16,087,281 | $17,336,446 | -$1,249,165 | Non-GAAP Financial Measures Reconciliation Adjusted Earnings Reconciliation For the six months ended June 30, 2025, adjusted earnings were $2.76 million, or $0.18 per diluted share, a significant improvement from an adjusted loss of $455,096, or -$0.03 per diluted share, in the prior year. This adjustment primarily accounts for income taxes, depreciation, amortization, share-based compensation, and interest Adjusted Earnings Reconciliation | Metric (6 Months Ended June 30) | 2025 | 2024 | | :------------------------------------------ | :----------- | :----------- | | Net income (loss) attributable to common shareholders | $516,328 | $(3,031,875) | | Adjustments (Income tax, D&A, Share-based comp, Interest) | $2,251,892 | $2,557,213 | | Adjusted earnings (loss) | $2,764,869 | $(455,096) | | Adjusted diluted EPS | $0.18 | $(0.03) | Explanation of Non-GAAP Measures Cumberland Pharmaceuticals uses non-GAAP financial measures like Adjusted Earnings and Adjusted Diluted Earnings Per Share to provide supplemental information for evaluating operating performance. These measures exclude items such as income taxes, depreciation, amortization, share-based compensation, and interest, which management believes are not indicative of core business performance or long-term strategic activities, offering greater transparency to investors - Non-GAAP measures (Adjusted Earnings, Adjusted Diluted EPS) are used by management and investors to evaluate operating performance, supplementing GAAP financial information[40][42] - These adjustments exclude items like income taxes, depreciation, amortization, share-based compensation, and interest, which are considered not indicative of core business performance or long-term strategic activities[42][43]