Financial Data and Key Metrics Changes - For Q3 2024, the company reported net revenue of $9.1 million, with year-to-date net revenues totaling $27 million [57][59] - The gross margin improved to 85% during the quarter [59] - The net loss for the quarter was $1.5 million, with an adjusted loss of $0.26 million or $0.02 per share [60] Business Line Data and Key Metrics Changes - Revenue breakdown for Q3 included $3.6 million from Kristalose, $2.6 million from Sancuso, $1.3 million from Caldolor, and $1 million from Vibativ [57] - Year-to-date product revenues were $10.9 million for Kristalose, $6.6 million for Sancuso, $5.1 million for Vibativ, and $3.6 million for Caldolor [59] Market Data and Key Metrics Changes - Kristalose performed best in states with Medicaid coverage, with new states adding it to their plans [14][30] - Vibativ faced challenges due to product returns and shipment delays caused by Hurricane Helene, impacting sales [11][58] Company Strategy and Development Direction - The company is focused on expanding its product portfolio through acquisitions of select FDA-approved brands [69] - New product development activities include treatments for delirium and a technology for locating internal bleeding sites [39][45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's future, citing steady performance in Kristalose and positive impacts from sales initiatives for Sancuso [67] - The company is encouraged by the progress of clinical studies for ifetroban and believes it has the potential to benefit many patients [68] Other Important Information - The company continues to hold over $52 million in tax net operating loss carryforwards [66] - A new smaller package for Vibativ was launched to cater to smaller hospitals and infusion centers [28] Q&A Session Summary - There were no questions from participants during the call, and management encouraged private discussions for those interested [70][71]

Product Portfolio and Development - Cumberland Pharmaceuticals Inc. has six FDA-approved products in the U.S. market, including Acetadote and Caldolor, targeting hospital acute care, gastroenterology, and oncology [84]. - The company is conducting Phase II clinical programs for its ifetroban product candidate, focusing on systemic sclerosis, cardiomyopathy associated with Duchenne Muscular Dystrophy, and idiopathic pulmonary fibrosis, with nearly 1,400 subjects dosed [108]. - Cumberland aims to expand its portfolio by acquiring under-promoted FDA-approved drugs and late-stage development products, exemplified by the acquisitions of Vibativ and Sancuso [90]. - The company is pursuing international partnerships to register and commercialize its products, including Vibativ in Saudi Arabia and Jordan through Tabuk Pharmaceutical [114]. - Cumberland's Caldolor product is expected to be eligible for special Medicare reimbursement under the NOPAIN Act, which applies to non-opioid pain management products from January 1, 2025 [102]. - The company has received Orphan Drug Designation and Rare Pediatric Disease Designation for its Duchenne Muscular Dystrophy product candidate, which may provide benefits during the FDA review process [110]. - The MENDING Trial enrolled 97 critically ill patients, demonstrating that the new treatment was well-tolerated and associated with a reduction in days with delirium [120][121]. - CET has entered into a Development Agreement with Octapharma AG for a new product to locate sites of internal bleeding, with development funding provided by Octapharma [123]. - The new technology for identifying GI bleeding sites represents a paradigm shift, allowing for pinpointing even if bleeding has temporarily ceased [126]. - The company continues to build its portfolio through the development of new candidates and acquisition of established brands, focusing on innovative and differentiated products [130]. Financial Performance - Net revenues for Q3 2024 were $9.1 million, a decrease of $1.0 million (9.9%) compared to $10.1 million in Q3 2023 [134]. - Vibativ revenue dropped to $1.0 million in Q3 2024 from $2.8 million in Q3 2023, a decline of $1.8 million (64.3%) due to lower sales volume [138]. - Sancuso revenue increased to $2.6 million in Q3 2024, up $0.7 million (36.3%) from $1.9 million in Q3 2023, driven by higher sales volume [138]. - Net revenues for the nine months ended September 30, 2024, were $27.4 million, a decrease of $2.8 million compared to $30.2 million for the same period in 2023 [149]. - Sancuso revenue increased to $6.6 million for the nine months ended September 30, 2024, compared to $5.7 million for the same period last year, primarily due to reduced sales deductions for product returns [153]. - Vibativ revenue for the nine months ended September 30, 2024, was $5.1 million, a decrease from $6.8 million in the prior year period, due to lower sales volume [153]. - Total costs and expenses for the nine months ended September 30, 2024, were $32.0 million, a decrease of $1.6 million compared to $33.6 million in the same period in 2023 [149]. - Operating loss for the nine months ended September 30, 2024, was $4.6 million, compared to a loss of $3.4 million for the same period in 2023, reflecting an increase of $1.2 million [149]. Cost Management and Expenses - Cost of products sold for Q3 2024 was $1.3 million, down $0.5 million (25.0%) from $1.8 million in Q3 2023, with a decrease in cost as a percentage of net revenues from 17.5% to 14.6% [140]. - Research and development costs decreased to $1.3 million in Q3 2024 from $1.9 million in Q3 2023, a reduction of $0.6 million (31.6%) due to variable costs associated with ongoing clinical initiatives [142]. - General and administrative expenses increased to $2.7 million in Q3 2024, up $0.4 million (17.4%) from $2.3 million in Q3 2023, attributed to higher salaries and contract labor costs [143]. - Research and development costs decreased to $3.5 million for the first nine months of 2024, down from $4.6 million in the same period last year, attributed to lower FDA fees and consulting expenses [157]. - General and administrative expenses increased to $7.8 million for the nine months ended September 30, 2024, compared to $7.2 million in the prior year, driven by higher salaries and contract labor costs [158]. Cash Flow and Liquidity - Cash and cash equivalents as of September 30, 2024, were $17.5 million, down from $18.3 million as of December 31, 2023 [166]. - Working capital decreased to $4.1 million as of September 30, 2024, compared to $7.7 million as of December 31, 2023 [166]. - The current ratio as of September 30, 2024, was 1.1, down from 1.3 as of December 31, 2023 [166]. - For the nine months ended September 30, 2024, cash used in operating activities totaled $2.5 million, primarily due to a net loss of $4.5 million and a $1.6 million increase in accounts receivable [168]. - Cash provided by financing activities amounted to $1.6 million, mainly from $3.3 million in borrowings on the line of credit, offset by $1.3 million for royalty payments and $0.5 million for share repurchases [169]. - The company entered into a new Revolving Credit Loan Agreement with Pinnacle Bank, providing up to $25 million, with an initial line of credit of $20 million and a three-year term expiring on October 1, 2026 [170]. - As of September 30, 2024, the applicable interest rate under the Loan Agreement was 8.000%, with $16.1 million in borrowings outstanding under the revolving credit facility [175]. - The company experienced a net decrease in cash and cash equivalents of $0.9 million for the nine months ended September 30, 2024, primarily due to cash used in operating activities [167]. - A $0.9 million decrease in non-cash contingent consideration and a $0.4 million decrease in other long-term liabilities contributed to the cash used in operating activities [168]. Risk Management - The company did not engage in any off-balance sheet arrangements during the nine months ended September 30, 2024 and 2023 [172]. - Interest rate risk related to cash and cash equivalents is considered not material, with no significant downside risk expected from changes in market interest rates [174]. - Foreign currency exchange gains and losses were immaterial for the nine months ended September 30, 2024 and 2023, with minimal exposure to foreign currency fluctuations [176]. - The company amended the Loan Agreement on May 6, 2024, providing an alternative to the financial covenant based on a borrowing base certificate [171].

Financial Performance - Cumberland Pharmaceuticals reported combined revenues of $9.1 million for Q3 2024, with year-to-date revenues totaling $27 million[1][17]. - The net loss for Q3 2024 was $1.5 million, or $0.11 per share, while adjusted loss was $0.26 million, or $0.02 per share[18]. - Total net revenues for the nine months ended September 30, 2024, were $27,432,376, a decrease of 9.3% compared to $30,199,441 for the same period in 2023[35]. - The company reported a net loss of $4,542,078 for the nine months ended September 30, 2024, compared to a net loss of $28,779 for the same period in 2023[36]. - For the three months ended September 2024, Cumberland reported a net loss attributable to common shareholders of $1,544,081, resulting in an earnings per share impact of $(0.11), compared to a net loss of $1,049,298 and an earnings per share impact of $(0.07) for the same period in 2023[37]. - For the year 2024, Cumberland reported a net loss attributable to common shareholders of $4,575,956, leading to an earnings per share impact of $(0.32), while in 2023, the net income was $15,086[38]. - Adjusted earnings for the year 2024 were $(720,032), with an adjusted diluted earnings per share of $(0.05), compared to adjusted earnings of $4,249,082 and an adjusted diluted earnings per share of $0.29 for 2023[38]. Assets and Liabilities - The company has $76.7 million in total assets and $52.3 million in total liabilities as of September 30, 2024[19]. - Cash and cash equivalents decreased to $17,464,754 as of September 30, 2024, from $18,321,624 at the end of 2023, representing a decline of 4.7%[36]. - Total current assets were $35,236,406 as of September 30, 2024, slightly down from $35,714,410 at the end of 2023[33]. - Total liabilities decreased marginally to $52,278,121 as of September 30, 2024, from $52,516,206 at the end of 2023[34]. - The company’s accumulated deficit increased to $(22,064,117) as of September 30, 2024, compared to $(17,488,161) at the end of 2023[34]. Research and Development - A new real-world study involving 150,000 patients showed that Caldolor is associated with a significantly reduced incidence of adverse drug reactions compared to ketorolac[3][4]. - The company is advancing a new treatment for delirium, with promising outcomes from the Phase II MENDING Trial[11]. - Ifetroban has been dosed in nearly 1,400 subjects, with three Phase II clinical programs currently underway[13]. - Cumberland received FDA Orphan Drug and Rare Pediatric Disease designations for its Duchenne Muscular Dystrophy product candidate[14][15]. Marketing and Sales - Kristalose's performance improved in states with Medicaid coverage, now including Virginia, Louisiana, and Maine[5]. - Cumberland launched new patient support initiatives for Sancuso, enhancing access for oncology patients[7]. - The company incurred selling and marketing expenses of $12,800,469 for the nine months ended September 30, 2024, down from $13,692,535 in the same period of 2023[35]. Financial Adjustments and Measures - Cumberland's management emphasizes the importance of adjusted financial measures as they provide insights into the company's operating performance by excluding non-core items such as depreciation, amortization, and share-based compensation[41]. - The company utilizes net operating loss carryforwards to minimize income tax expenses, which is reflected in the adjusted earnings calculations[41]. - Adjusted earnings are defined as net income (loss) adjusted for income taxes, depreciation and amortization, share-based compensation, interest income, and interest expense[42]. - The company encourages investors to review its consolidated financial statements and publicly filed reports in their entirety for a comprehensive understanding of its financial performance[40]. Operating Loss - Operating loss for the nine months ended September 30, 2024, was $(4,590,370), compared to $(3,375,422) for the same period in 2023[35]. - Research and development expenses were $3,523,535 for the nine months ended September 30, 2024, compared to $4,569,476 for the same period in 2023, reflecting a decrease of 22.9%[35]. - The company reported a basic and diluted loss per share of $(0.32) for the nine months ended September 30, 2024[35]. - Adjusted earnings for the three months ended September 2024 were $(264,936), with an adjusted diluted earnings per share of $(0.02), while for the same period in 2023, adjusted earnings were $260,146, resulting in an adjusted diluted earnings per share of $0.02[37]. - The diluted weighted-average common shares outstanding for the three months ended September 2024 were 14,052,754, compared to 14,422,274 for the same period in 2023[37]. - The diluted weighted-average common shares outstanding for the year 2024 were 14,089,496, compared to 14,559,687 for 2023[38].

Core Insights - Cumberland Pharmaceuticals announced new research showing Caldolor (ibuprofen) injection has safety and healthcare resource advantages over ketorolac in both adult and pediatric populations [1][2] - The study indicates that Caldolor is linked to fewer adverse drug reactions (ADRs) and improved healthcare utilization compared to ketorolac [1][3] Study Overview - The research involved a retrospective analysis of over 17 million patient records, focusing on 31,046 adult patients using Caldolor and 124,184 using ketorolac, along with 5,579 pediatric patients in separate claims analysis [2] Key Findings - In adults, Caldolor showed a 45% reduction in renal dysfunction (p<0.001) and a 78% decrease in hematuria rates (p<0.001) compared to ketorolac [3] - Pediatric patients experienced a 51-65% lower rate of ADRs, including headache and nausea, with 95% confidence intervals indicating clinical significance [3] Healthcare Resource Utilization - Caldolor demonstrated a positive impact on healthcare resource utilization, leading to decreased emergency room and outpatient visits, as well as shorter hospital stays for both adults and children [4] Company Perspective - The CEO of Cumberland Pharmaceuticals emphasized that these findings highlight Caldolor's potential to enhance patient care by reducing treatment complications and offering potential savings for healthcare systems through decreased hospital readmissions and shorter treatment times [5] Product Information - Caldolor is indicated for managing mild to moderate pain and reducing fever in both adults and pediatric patients, being the first FDA-approved intravenous therapy for fever [6]

NASHVILLE, Tenn., Oct. 31, 2024 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, announced today that it will release its third quarter 2024 financial results and provide a company update after the market closes on Thursday, Nov. 7, 2024.A conference call will be held on Nov. 7 at 4:30 p.m. Eastern Time to discuss the results. To participate in the call, please register at https://register.vevent.com/register/BIdd190691b1df432e9f1f65383f53b384.Once register ...

Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) Q2 2024 Results Earnings Conference Call August 6, 2024 4:30 PM ET Company Participants Molly Aggas - Investor Relations, 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 Second Quarter 2024 Financial Report and Company Update. This call is being recorded at the company's ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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 June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number: 001-33637 Cumberland Pharmaceuticals Inc. (Exact Name of Registrant as Specified In Its Charter) Tennessee 62-1765329 (State or Othe ...

Cumberland Pharmaceuticals Reports 16% Sequential Revenue Growth in Second Quarter 2024 NASHVILLE, TENNESSEE (Tuesday, August 6, 2024) – Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, today announced significantly improved financial results and a favorable overall company performance for the second quarter of 2024. Highlights include: • $9.9 million in net revenue during the second quarter of 2024, an increase of 16% sequentially from the first quarter of 2024. • Adjuste ...

NASHVILLE, Tenn., Aug. 6, 2024 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, today announced significantly improved financial results and a favorable overall company performance for the second quarter of 2024. Highlights include: $9.9 million in net revenue during the second quarter of 2024, an increase of 16% sequentially from the first quarter of 2024. Adjusted earnings of $0.2 million, which represents a $0.8 million improvement over the prior period ...

A conference call will be held on Aug. 6 at 4:30 p.m. Eastern Time to discuss the results. To participate in the call, please register at https://register.vevent.com/register/BIfa6a94515e5548c28e9d77d03c95a13e. A replay of the call will be available for one year and can be accessed via Cumberland's website or by visiting https://edge.media-server.com/mmc/p/h9bx4zn8. The company's portfolio of FDA-approved brands includes: The company also has a series of Phase II clinical programs underway evaluating its if ...