Financial Data and Key Metrics Changes - For Q2 2025, net revenue from continuing operations was $10.8 million, representing a 10% increase over the prior year period [24] - Year-to-date revenues for the first six months totaled $22.6 million, a 23% increase compared to the same period last year [11][24] - Adjusted earnings for Q2 were $400,000, and for the first half of the year, adjusted earnings were $2.8 million or $0.18 per share, significantly up from the previous year [11][25] - The company generated $4.7 million in cash flow from operations during the first half of 2025 [11] Business Line Data and Key Metrics Changes - Revenue by product for Q2 included $2.8 million for Cristalose, $3.1 million for Sancuso, $2.7 million for Vibativ, and $1.6 million for Caldolor [24] - Year-to-date product revenue totaled $6.2 million for Cristalose, $4.1 million for Vibativ, $5.4 million for Sancuso, and $2.9 million for Caldolor [24] Market Data and Key Metrics Changes - The company announced the approval of Vibativ in China, providing access to the world's second-largest pharmaceutical market [10] - A partnership with Tabuk Pharmaceuticals was established to introduce Vibativ into the Middle East, with shipments already initiated [10] Company Strategy and Development Direction - The company is focused on building a portfolio of FDA-approved brands with strong safety and efficacy profiles [31] - There is an emphasis on expanding international contributions and pursuing new opportunities through the addition of new products [31] - The company is dedicated to addressing unmet medical needs through its clinical pipeline, particularly with the ifetroban product candidate [31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's future, citing positive developments in clinical studies and product approvals [8][31] - The company is preparing for a meeting with the FDA to discuss the clinical program for ifetroban, which is seen as a potential treatment for DMD cardiomyopathy [9][31] Other Important Information - The company holds $68 million in total assets, including $16 million in cash and cash equivalents, with liabilities totaling $40 million [28] - Cumberland continues to hold over $52 million in tax net operating loss carryforwards, primarily from prior stock option exercises [29] Q&A Session Summary - No questions were raised during the Q&A session, and management expressed willingness to engage in private discussions with shareholders if desired [34][35]

[Executive Summary & Financial Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Financial%20Highlights) [Q2 & YTD Financial Performance](index=1&type=section&id=Q2%20%26%20YTD%20Financial%20Performance) 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](index=1&type=section&id=Balance%20Sheet%20Snapshot) 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](index=1&type=section&id=CEO%20Commentary) 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](index=3&type=chunk) [Recent Company Developments](index=1&type=section&id=RECENT%20COMPANY%20DEVELOPMENTS) [Vibativ Product Updates](index=1&type=section&id=Vibativ%20Product%20Updates) 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](index=4&type=chunk)[5](index=5&type=chunk) - A comprehensive pharmacokinetic analysis of Vibativ, published in June 2025, supports optimized dosing strategies for various infection severities and renal functions[6](index=6&type=chunk) [Ifetroban Clinical Program](index=2&type=section&id=Ifetroban%20Clinical%20Program) 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](index=2&type=section&id=Duchenne%20Muscular%20Dystrophy%20(DMD)%20Trial) 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](index=7&type=chunk) - 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](index=8&type=chunk) [Systemic Sclerosis Study](index=2&type=section&id=Systemic%20Sclerosis%20Study) 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](index=9&type=chunk) [Idiopathic Pulmonary Fibrosis (IPF) Trial](index=2&type=section&id=Idiopathic%20Pulmonary%20Fibrosis%20(IPF)%20Trial) 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](index=10&type=chunk) [Caldolor Study Publication](index=2&type=section&id=Caldolor%20Study%20Publication) 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](index=11&type=chunk) [Detailed Financial Results](index=3&type=section&id=FINANCIAL%20RESULTS) [Net Revenue Breakdown](index=3&type=section&id=Net%20Revenue%20Breakdown) 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](index=3&type=section&id=Operating%20Expenses) 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](index=3&type=section&id=Net%20Income%20(Loss)%20%26%20Adjusted%20Earnings) 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](index=3&type=section&id=Balance%20Sheet%20Summary) 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](index=3&type=section&id=EARNINGS%20REPORT%20CALL) 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](index=15&type=chunk)[16](index=16&type=chunk) [About Cumberland Pharmaceuticals](index=4&type=section&id=ABOUT%20CUMBERLAND%20PHARMACEUTICALS) [Company Overview](index=4&type=section&id=Company%20Overview) 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](index=17&type=chunk) - The company is developing its ifetroban product candidate through Phase II clinical programs for Duchenne Muscular Dystrophy, Systemic Sclerosis, and Pulmonary Fibrosis[17](index=17&type=chunk) [Product Portfolio Details](index=4&type=section&id=Product%20Portfolio%20Details) 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](index=4&type=section&id=Acetadote%20(acetylcysteine)%20Injection) 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](index=19&type=chunk)[22](index=22&type=chunk) [Caldolor (ibuprofen) Injection](index=4&type=section&id=Caldolor%20(ibuprofen)%20Injection) 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](index=20&type=chunk)[22](index=22&type=chunk) - Caldolor is contraindicated in patients with known hypersensitivity to NSAIDs or during the peri-operative period of coronary artery bypass graft (CABG) surgery[21](index=21&type=chunk) [Kristalose (lactulose) Oral Solution](index=5&type=section&id=Kristalose%20(lactulose)%20Oral%20Solution) 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](index=22&type=chunk)[23](index=23&type=chunk) [Sancuso (granisetron) Transdermal System](index=5&type=section&id=Sancuso%20(granisetron)%20Transdermal%20System) 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](index=22&type=chunk)[24](index=24&type=chunk) [Vaprisol (conivaptan hydrochloride) Injection](index=5&type=section&id=Vaprisol%20(conivaptan%20hydrochloride)%20Injection) 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](index=22&type=chunk)[25](index=25&type=chunk) - Vaprisol is contraindicated in patients with hypovolemic hyponatremia and with coadministration of potent CYP3A inhibitors[25](index=25&type=chunk) [Vibativ (telavancin) for Injection](index=5&type=section&id=Vibativ%20(telavancin)%20for%20Injection) 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](index=22&type=chunk)[26](index=26&type=chunk) - Vibativ is contraindicated with intravenous unfractionated heparin sodium and in patients with known hypersensitivity to telavancin[26](index=26&type=chunk) [About Cumberland Emerging Technologies](index=5&type=section&id=ABOUT%20CUMBERLAND%20EMERGING%20TECHNOLOGIES) 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](index=27&type=chunk) - CET offers expertise in intellectual property, regulatory, manufacturing, and marketing, and provides laboratory space for early-stage life sciences ventures[28](index=28&type=chunk) [Forward-Looking Statements](index=6&type=section&id=FORWARD%20LOOKING%20STATEMENTS) 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](index=29&type=chunk) - Readers are cautioned not to place undue reliance on forward-looking statements, and the company disclaims any obligation to publicly revise them[29](index=29&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=10&type=section&id=Non-GAAP%20Financial%20Measures%20Reconciliation) [Adjusted Earnings Reconciliation](index=10&type=section&id=Adjusted%20Earnings%20Reconciliation) 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](index=11&type=section&id=Explanation%20of%20Non-GAAP%20Measures) 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](index=40&type=chunk)[42](index=42&type=chunk) - 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](index=42&type=chunk)[43](index=43&type=chunk)

Core Insights - Cumberland Pharmaceuticals Inc. reported a strong financial performance with combined net revenues of $10.8 million in Q2 2025, marking a 10% increase year-over-year [1][12] - Year-to-date revenues reached $22.6 million, reflecting a 23% increase compared to the first half of 2024 [1][12] - The company ended the quarter with total assets of approximately $68 million and shareholders' equity of $28 million [2][14] Financial Performance - Q2 2025 net revenues included $2.8 million from Kristalose®, $3.1 million from Sancuso®, $2.7 million from Vibativ®, and $1.6 million from Caldolor® [12] - Total operating expenses for Q2 2025 were $11.6 million, leading to a net loss of approximately $741,000 for the quarter [13][33] - Year-to-date net income was approximately $516,000, with adjusted earnings of $2.8 million or $0.18 per diluted share [13][37] Product Developments - Cumberland announced the availability of the Vibativ 4-Vial Starter Pak through a new supply arrangement with Vizient Inc., enhancing access for healthcare providers [3][4] - A new pharmacokinetic analysis of Vibativ supports optimized dosing strategies for treating life-threatening gram-positive infections [5] - Breakthrough findings from the Phase II FIGHT DMD trial for ifetroban showed a 5.4% improvement in cardiac function in patients with Duchenne muscular dystrophy [6][7] Clinical Trials - Cumberland is conducting a Phase II clinical program for ifetroban in patients with Systemic Sclerosis, with enrollment completed [8] - The FIGHTING FIBROSIS™ trial is underway for patients with Idiopathic Pulmonary Fibrosis, with patient enrollment ongoing [9] - A study on Caldolor® demonstrated its safety and efficacy for managing post-operative pain in patients aged 60 and older [10][11] Balance Sheet - As of June 30, 2025, Cumberland had total assets of approximately $68 million, with $16 million in cash and cash equivalents [14][31] - Total liabilities were reported at $40 million, including $5 million on the company's credit facility [14][31] - Shareholders' equity stood at $28 million, reflecting a solid financial position [14][32]

Core Insights - Cumberland Pharmaceuticals Inc. announced the availability of the Vibativ® (telavancin) 4-Vial Starter Pak through a new contract with Vizient, enhancing access for healthcare providers [1][2][3] Group 1: Product Availability and Market Reach - Vizient serves over 65% of the nation's acute care providers, including 97% of academic medical centers and 35% of the non-acute market, facilitating increased access to Vibativ's new 4-vial configuration [2] - The Vibativ 4-Vial Starter Pak supports flexible treatment initiation in both inpatient and outpatient settings, aimed at improving patient care [2][3] Group 2: Product Information - Vibativ is an FDA-approved injectable antibiotic indicated for treating hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and complicated skin and skin structure infections (cSSSI) caused by Gram-positive pathogens, including MRSA [4][6] - The product is available in both 4-vial and 12-vial configurations through various distribution channels for Vizient provider clients [4] Group 3: Clinical Efficacy - Vibativ has demonstrated significantly higher cure rates compared to vancomycin in treating HABP/VABP due to Gram-positive pathogens, supported by large multinational studies [7] - The drug exhibits in vitro potency and in vivo activity against a broad range of difficult-to-treat Gram-positive bacterial pathogens, including multidrug-resistant strains [7]

Company Update - Cumberland Pharmaceuticals Inc. will release its second quarter 2025 financial results and provide a company update on August 5, 2025, after market close [1] - A conference call is scheduled for August 5 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]

Core Insights - Cumberland Pharmaceuticals Inc. presented positive results from the Phase 2 FIGHT DMD trial for ifetroban, a novel oral therapy targeting Duchenne muscular dystrophy (DMD) heart disease, at the PPMD conference, indicating its potential to protect the heart and reduce cardiac damage in DMD patients [1][2][8] Group 1: Trial Results - The 12-month Phase 2 FIGHT DMD trial demonstrated a significant 5.4% improvement in left ventricular ejection fraction (LVEF) in patients treated with high-dose ifetroban compared to a control group [4] - High-dose ifetroban treatment was associated with reduced blood levels of cardiac damage markers (NT-proBNP and cardiac troponin I), while these markers increased in placebo-treated patients, suggesting ifetroban's potential to prevent ongoing cardiac injury [5] - All patients who completed the study opted to continue with the open-label extension, indicating confidence in the treatment [7] Group 2: Pharmacokinetics and Tolerability - The study revealed that DMD patients receiving higher doses of ifetroban achieved similar plasma levels to typical adults without evidence of drug accumulation, supporting the 300 mg daily dosing used in the high-dose group [6] - Ifetroban was well-tolerated with an acceptable pharmacokinetic profile in patients with DMD, despite the higher dosing requirements [6] Group 3: Market Potential and Regulatory Pathway - Ifetroban is positioned to address the leading cause of death in DMD patients, with no approved treatment specifically targeting DMD heart disease, highlighting a critical unmet medical need [9][10] - The company plans to analyze long-term treatment results and engage in discussions with the FDA regarding the regulatory pathway forward based on the trial's encouraging results [10]

Core Insights - The study published by Cumberland Pharmaceuticals demonstrates a 23% reduction in morphine use among older patients treated with Caldolor, indicating its efficacy and safety in pain management for this demographic [1][6][4] - The analysis highlights the unique challenges of pain management in older patients, who are often underrepresented in clinical trials, emphasizing the medical need for effective non-opioid analgesics [2][4] Study Details - The analysis involved a post-hoc subgroup analysis of data from four prospective clinical studies, including 591 patients from two placebo-controlled trials for efficacy and 1,041 patients for safety assessment [3] - Caldolor treatment resulted in a 24% reduction in pain at rest and a 20% reduction in pain with movement between 6 and 24 hours post-surgery compared to placebo [6] Safety Profile - The incidence of adverse events was significantly lower in patients treated with Caldolor (55%) compared to those receiving placebo (90%) in older patients [6] - No notable increases in gastrointestinal, renal, cardiovascular, or bleeding adverse events were observed with Caldolor treatment [6] Company Commitment - Cumberland Pharmaceuticals emphasizes its commitment to providing safe and effective pain management options, particularly for the growing aging population [5] - The company has previously published positive results regarding Caldolor's safety and pharmacokinetics in newborns, showcasing its dedication to expanding clinical applications across various age groups [5] Future Directions - Next steps for the company include outreach to healthcare providers to share the findings of this study, reinforcing the importance of Caldolor in multimodal analgesia regimens for older patients [7]

PART I – FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Presents Cumberland Pharmaceuticals Inc.'s unaudited condensed consolidated financial statements for Q1 2025, including balance sheets, operations, cash flows, and equity [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $69.9 million, liabilities reduced to $41.6 million, and equity increased to $28.3 million by Q1 2025 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $15,108 | $17,964 | | Total current assets | $31,877 | $36,452 | | Total assets | $69,936 | $75,583 | | **Liabilities & Equity** | | | | Total current liabilities | $25,520 | $31,622 | | Revolving line of credit - long term | $5,241 | $10,176 | | Total liabilities | $41,595 | $53,037 | | Total equity | $28,341 | $22,546 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2025 net income of $1.25 million on $11.7 million net revenues marks a significant turnaround from the prior year's loss Q1 2025 vs. Q1 2024 Statement of Operations (in thousands) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net revenues | $11,713 | $8,498 | | Total costs and expenses | $10,421 | $10,367 | | Operating income (loss) | $1,292 | $(1,869) | | Net income (loss) | $1,248 | $(1,902) | | Diluted EPS | $0.08 | $(0.14) | [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2025 operating activities provided $3.9 million cash, reversing a prior year use, resulting in a $2.9 million overall cash decrease Q1 2025 vs. Q1 2024 Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $3,899 | $(2,137) | | Net cash used in investing activities | $(1,228) | $(58) | | Net cash provided by (used in) financing activities | $(5,526) | $2,422 | | Net (decrease) increase in cash | $(2,856) | $227 | - Financing activities in Q1 2025 included **$5.3 million** in net proceeds from an At-the-Market (ATM) offering and **$10.0 million** in payments on the line of credit[13](index=13&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) Notes detail accounting policies and financial statement items, including product revenues, inventory, lease, debt, and contingent liabilities Net Revenues by Product (in thousands) | Product | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Kristalose | $3,484 | $3,196 | | Sancuso | $2,256 | $1,828 | | Vibativ | $1,378 | $1,605 | | Caldolor | $1,307 | $1,471 | | Other revenue | $3,142 | $275 | | **Total net revenues** | **$11,713** | **$8,498** | - Other revenue in Q1 2025 includes a **$3.0 million** milestone payment related to the approval of Vibativ for the Chinese market[41](index=41&type=chunk) - On February 5, 2025, the Company issued 1,000,000 shares under an At-the-Market (ATM) program for an aggregate amount of **$5.5 million**[57](index=57&type=chunk) - As of March 31, 2025, the company had **$5.2 million** in borrowings outstanding under its revolving credit facility with Pinnacle Bank at an interest rate of **7.125%**[62](index=62&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2025's profitability turnaround, driven by $11.7 million net revenue, outlining growth strategy and solid liquidity [Growth Strategy](index=23&type=section&id=Growth%20Strategy) The company's growth strategy focuses on maximizing existing brands, acquiring new ones, advancing its clinical pipeline, and building international partnerships - Cumberland's growth strategy includes: - Supporting and expanding the use of its marketed products - Selectively acquiring complementary brands and late-stage candidates - Progressing its clinical pipeline, including ifetroban Phase II programs - Leveraging infrastructure through co-promotion partnerships - Building an international business through a network of partners[90](index=90&type=chunk)[91](index=91&type=chunk) [Recent Developments](index=24&type=section&id=Recent%20Developments) Recent developments include Acetadote FDA approval, positive Caldolor and ifetroban study results, and Vibativ's China approval and Saudi launch - The FDA approved a supplemental New Drug Application for Acetadote, simplifying its dosing regimen to reduce medication errors[92](index=92&type=chunk)[93](index=93&type=chunk) - A new study of **150,000** patients showed Caldolor was associated with significantly reduced adverse drug reactions compared to ketorolac[94](index=94&type=chunk)[95](index=95&type=chunk) - The company announced positive top-line results from its Phase II study of ifetroban in patients with Duchenne muscular dystrophy (DMD)[97](index=97&type=chunk) - Vibativ received regulatory approval in China, and the company began shipping the product to Saudi Arabia for its launch[100](index=100&type=chunk)[101](index=101&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Net revenues for Q1 2025 increased by 38% to $11.7 million, primarily due to a $3.0 million Vibativ milestone, resulting in $1.3 million operating income Q1 2025 vs. Q1 2024 Operations Summary (in thousands) | Line Item | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Net revenues | $11,713 | $8,498 | $3,215 | | Cost of products sold | $1,426 | $1,576 | $(150) | | Operating income (loss) | $1,292 | $(1,869) | $3,161 | | Net income (loss) | $1,248 | $(1,902) | $3,151 | - The increase in Other Revenue from **$0.3 million** to **$3.1 million** was driven by a **$3 million** milestone payment for Vibativ's approval in China[116](index=116&type=chunk) - Sancuso revenue increased by **$0.4 million** due to increased shipments and lower sales deductions[115](index=115&type=chunk) Financial Contribution of Vibativ and Sancuso (in thousands) | Product Contribution | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | **Vibativ** | | | | Net Revenue* | $4,353 | $1,605 | | Contribution | $3,594 | $850 | | **Sancuso** | | | | Net Revenue | $2,256 | $1,828 | | Contribution | $1,183 | $1,043 | *Vibativ Q1 2025 Net Revenue includes a $2,975,000 milestone payment. [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity is sourced from cash, operations, and a revolving credit line, with working capital improving to $6.4 million and $15.1 million cash by Q1 2025 Liquidity and Working Capital Summary (in thousands) | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $15,108 | $17,964 | | Working capital | $6,358 | $4,830 | | Revolving line of credit availability | $14,759 | $4,724 | - Cash provided by operating activities was **$3.9 million** for Q1 2025, a significant improvement from a **$2.1 million** use of cash in Q1 2024[125](index=125&type=chunk)[126](index=126&type=chunk) - Cash used in financing activities was **$5.5 million**, primarily due to **$10.0 million** in payments on the line of credit, offset by **$5.3 million** in proceeds from an ATM offering[127](index=127&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces interest rate risk on its variable-rate credit facility, with minimal foreign currency exchange risk due to primarily U.S. operations - The company is exposed to interest rate risk on its revolving credit facility, which is based on Term SOFR plus a spread. The applicable rate was **7.125%** at March 31, 2025, on **$5.2 million** of outstanding borrowings[133](index=133&type=chunk) - Foreign currency exchange risk is considered minimal as operations are primarily in the United States and exposure is limited[134](index=134&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) The CEO and CFO concluded disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting - Management, including the CEO and CFO, concluded that the Company's disclosure controls and procedures were effective as of March 31, 2025[135](index=135&type=chunk) - No changes in internal control over financial reporting occurred during Q1 2025 that materially affected, or are reasonably likely to materially affect, internal controls[136](index=136&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in litigation but does not expect a material adverse effect on its business or financial condition - The Company does not believe that the disposition or ultimate resolution of existing claims or lawsuits will have a material adverse effect on its business or financial condition[66](index=66&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) This section refers investors to the risk factors detailed in the Company's Annual Report on Form 10-K for 2024 - Investors are directed to consider the risk factors included in the Company's Annual Report on Form 10-K for the year ended December 31, 2024[139](index=139&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company repurchased 53,837 shares for $0.2 million in Q1 2025 under its $10 million program, with $2.2 million remaining available - During Q1 2025, the Company repurchased **53,837** shares of common stock for approximately **$0.2 million**[55](index=55&type=chunk) Share Repurchases in Q1 2025 | Period | Total Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | January | 15,770 | $2.51 | | February | — | — | | March | 38,067 | $5.36 | | **Total** | **53,837** | | - As of March 31, 2025, approximately **$2.2 million** remained available for future repurchases under the current program[55](index=55&type=chunk) [Other Information](index=33&type=section&id=Item%205.%20Other%20Information) Several officers and directors adopted Rule 10b5-1 trading plans to purchase company stock, effective March 2025 through year-end - The CEO and several directors adopted Rule 10b5-1 trading plans to purchase company stock, which became effective on March 3, 2025[142](index=142&type=chunk) [Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including employment agreements and CEO/CFO certifications - The report includes various exhibits, such as CEO and CFO certifications (31.1, 31.2, 32.1) and Inline XBRL data files[143](index=143&type=chunk)

Financial Data and Key Metrics Changes - The company reported combined revenues of $11.7 million for Q1 2025, representing a 38% increase compared to the prior year period [9] - Net profit for the quarter was $1.26 million, with adjusted earnings of $2.4 million and cash flow from operations of $3.9 million [9][27] - Total assets improved to $70 million, including $50 million in cash, while total liabilities decreased to $42 million [9][30] Business Line Data and Key Metrics Changes - Revenue breakdown for Q1 2025 included $3.5 million for Cristalos, $2.3 million for SANKUSO, $1.4 million for Vibativ, and $1.3 million for Caldolor [27] - The company launched new marketing initiatives and expanded its sales force to support its FDA-approved products [12][18] Market Data and Key Metrics Changes - The approval of Vibativ in China opens access to a significant pharmaceutical market, expected to enhance revenue opportunities [11] - The company is focusing on states with Medicaid coverage to boost Cristalos sales, seeing favorable impacts from formulary additions [16] Company Strategy and Development Direction - The company aims to support its FDA-approved portfolio through dedicated sales divisions and strategic marketing initiatives [33] - There is a focus on addressing antimicrobial resistance through Vibativ's unique dual mechanism of action [14][33] - The company is also exploring targeted acquisitions to create new opportunities [34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's future, citing strong performance and positive developments in the pipeline [7][9] - The company is preparing for further data analysis and meetings with the FDA regarding its ifetroban product candidate for DMD [10][25] Other Important Information - The company continues to hold over $53 million in tax net operating loss carryforwards, primarily from prior stock option exercises [31] - A new digital marketing strategy is being implemented to enhance visibility and engagement for all marketed brands [19] Q&A Session Summary Question: Future growth prospects for Cumberland - Management highlighted the strong start to the year and the positive momentum across approved brands, expecting continued growth and progress in clinical pipelines [34] Question: Plans for shareholder engagement - Management indicated willingness to schedule private discussions with shareholders for further engagement [36]

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].