NASHVILLE, Tenn., Feb. 4, 2026 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on developing new products for rare diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its novel oral therapy targeting a fatal form of heart disease in Duchenne muscular dystrophy (DMD) patients. About Duchenne Muscular Dystrophy (DMD) DMD is a rare and incurable pediatric disease affecting approximately 1 in ...

NASHVILLE, Tenn., Feb. 4, 2026 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on developing new products for rare diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its novel oral therapy targeting a fatal form of heart disease in Duchenne muscular dystrophy (DMD) patients. The FDA's Fast Track program facilitates the development and expedites the review of a drug designed to treat a se ...

Industry Overview - The medical and health products industry is evolving under regulatory pressures and the need for differentiated, clinically validated solutions, with a focus on niche markets and specialty products [1] - There is a growing emphasis on targeted therapies and specialty products to meet clearly defined patient needs, alongside operational discipline and cash-flow generation amid rising costs and regulatory complexity [2] - Companies expect performance to be influenced by their ability to execute within niche markets, maintain regulatory compliance, and convert prior investments into incremental revenues and margin improvement [3] Cumberland Pharmaceuticals (CPIX) - Cumberland Pharmaceuticals operates as a specialty pharmaceutical company focused on branded prescription products in hospital acute care, gastroenterology, and oncology markets, with a portfolio of FDA-approved products [5] - For the first nine months of 2025, CPIX generated $30.8 million in net revenues, representing year-over-year growth, and produced a positive operating cash flow of $4.9 million [6] - CPIX is expanding its commercial portfolio with the addition of Talicia, an FDA-approved treatment for H. pylori infection, and is advancing international expansion initiatives and Phase II clinical programs for ifetroban [7][8] Natural Alternatives International (NAII) - NAII operates in nutritional supplement manufacturing and ingredient commercialization, serving as a leading private-label contract manufacturer for vitamins and supplements [9] - For fiscal 2025, NAII reported net sales of $129.9 million, primarily from private-label contract manufacturing, with a strong operational foundation supported by advanced manufacturing facilities and certifications [10] - NAII's growth priorities include expanding customer relationships, broadening branded ingredient adoption, and pursuing complementary acquisitions, with a focus on high-quality nutritional supplements [11][12] ImmuCell Corporation (ICCC) - ImmuCell focuses on improving the health and productivity of dairy and beef cattle, with its core product, First Defense, providing immediate immunity to newborn calves [13] - In the first nine months of 2025, ImmuCell reported $20 million in product sales and a net income of $1.8 million, attributed to higher production output and improved gross margin [14] - The company is expanding production capacity to support an annualized revenue run rate approaching $30 million and is focused on the regulatory progress of Re-Tain, a treatment for mastitis [15][16] Conclusion - CPIX, NAII, and ICCC demonstrate how focused strategies and regulatory alignment can support growth in highly regulated healthcare markets, leveraging specialization and disciplined operations [17][18]

Core Viewpoint - Zacks Investment Research has initiated coverage of Cumberland Pharmaceuticals Inc. with an "Outperform" recommendation, highlighting the company's unique specialty pharmaceutical model and long-term growth potential [1] Company Overview - Cumberland Pharmaceuticals is a Nashville-based specialty pharma company focused on acquiring, developing, and commercializing branded prescription products in hospital acute care, gastroenterology, and oncology markets [2] - The company's strategy involves leveraging an established commercial platform to integrate under-promoted, FDA-approved brands while maintaining disciplined capital deployment [2] Growth Drivers - The investment thesis is centered on Cumberland Pharmaceuticals' scalable sales infrastructure, which allows efficient absorption of new products without significantly increasing fixed costs [3] - Talicia, a recently added FDA-approved therapy for H. pylori infection, is identified as a key near to medium-term value driver, generating approximately $8 million in U.S. net sales in 2024 before Cumberland's involvement [4] - The partnership structure for Talicia allows Cumberland to gain 50% of net revenues with a modest capital commitment, enhancing revenue visibility and limiting execution risks [4] - The company has a meaningful pipeline upside through ifetroban, a late-stage clinical asset, with positive Phase II data in Duchenne muscular dystrophy cardiomyopathy [5] Financial Considerations - Cumberland Pharmaceuticals remains GAAP unprofitable, with operating expenses outpacing revenue growth, and selling and marketing costs remain elevated [6] - The company faces product concentration risks as sales of Kristalose decline, increasing reliance on acquired products like Vibativ and Sancuso, which carry ongoing royalty and milestone obligations [7] - Balance sheet considerations include significant intangible assets and inventory, which pose potential impairment risks if product performance weakens [8] Valuation Perspective - Shares of Cumberland Pharmaceuticals trade at a discount to sector and industry peers on EV/Sales and EV/EBITDA metrics, despite improving revenue momentum [9] - This valuation presents an attractive entry point for investors seeking exposure to a small-cap specialty pharmaceutical company with stable commercial assets and longer-term pipeline-driven upside [9]

Core Insights - Cumberland Pharmaceuticals has announced that its Caldolor (ibuprofen) Injection is now associated with a permanent J-code (J1741) and a reimbursement price, providing a CMS-covered non-opioid option for pain and fever management [1][2][5] Group 1: Product Update - Caldolor is now linked to an established reimbursement price, allowing healthcare providers to access a reimbursable non-opioid alternative for pain management [3] - The product is indicated for managing mild to moderate pain and as an adjunct for moderate to severe pain, as well as for fever reduction [4] Group 2: Industry Context - The introduction of Caldolor as a non-opioid alternative is significant in the context of the ongoing opioid crisis, supporting safer pain management strategies [2] - The update aligns with opioid-sparing initiatives, helping healthcare providers make clinically appropriate decisions [3] Group 3: Company Overview - Cumberland Pharmaceuticals is the largest biopharmaceutical company based in Tennessee, focusing on unique products that enhance patient care [5] - The company’s portfolio includes several FDA-approved products, with Caldolor being a key offering [6]

Revenue Performance - Cumberland Pharmaceuticals reported net revenues of $8 million for Talicia in 2024, following a joint commercialization agreement with RedHill Biopharma[98]. - Net revenues for Q3 2025 were $8.3 million, a decrease of 8.7% from $9.1 million in Q3 2024[119]. - Kristalose revenue dropped to $1.2 million in Q3 2025 from $3.6 million in Q3 2024, primarily due to lower sales volume and increased generic substitution[120]. - Vibativ revenue increased to $2.6 million in Q3 2025 from $1.0 million in Q3 2024, attributed to higher sales volumes[123]. - Sancuso revenue rose to $3.2 million in Q3 2025, up from $2.6 million in Q3 2024, reflecting increased shipments and lower sales deductions[124]. - Net revenues for the nine months ended September 30, 2025, were $30.8 million, an increase of $3.4 million (12.4%) compared to $27.4 million in the same period of 2024[133]. - Kristalose revenue decreased to $7.4 million from $10.9 million, a decline of $3.5 million (32.2%), primarily due to lower sales volume and increased generic substitution[134]. - Sancuso revenue increased to $8.6 million, up $1.99 million (30.1%) from $6.6 million, driven by increased shipments and lower sales deductions[136]. - Vibativ revenue rose to $6.7 million, an increase of $1.59 million (31.3%) compared to $5.1 million, attributed to higher sales volumes[137]. Expenses and Financial Management - Total costs and expenses decreased to $10.3 million in Q3 2025 from $10.8 million in Q3 2024, resulting in an operating loss of $2.0 million[119]. - Research and development expenses for Q3 2025 were $1.3 million, slightly down from $1.3 million in Q3 2024[126]. - General and administrative expenses decreased to $2.6 million in Q3 2025 from $2.7 million in Q3 2024, due to lower corporate life insurance expenses[127]. - Research and development expenses increased to $4.0 million, up $0.5 million (14.1%) from $3.5 million, reflecting ongoing clinical initiatives[141]. - General and administrative expenses slightly increased to $7.9 million from $7.8 million, primarily due to higher salary expenses[142]. - The company reported an operating loss of $1.4 million, an improvement of $3.17 million (69.0%) compared to a loss of $4.6 million in the prior year[132]. - Cash provided by operating activities totaled $4.9 million, a significant turnaround from a cash used of $2.5 million in the same period last year[150]. Strategic Initiatives - The company is pursuing a growth strategy that includes acquiring additional marketed brands and late-stage development products to enhance its portfolio[95]. - The company is focused on capitalizing on growth opportunities from approved brands, international partnerships, and potential acquisitions[114]. - Cumberland has secured pediatric approval for Acetadote and Caldolor, expanding their labeling to include newborns and pre-surgery dosing[97]. - The company aims to leverage its commercial infrastructure through co-promotion partnerships to drive prescription volume and product sales[97]. - Cumberland's partnership with RedHill for Talicia includes a $4 million investment over two years, with Cumberland retaining 30% ownership in the new joint venture[98]. - The company has established international partnerships to expand the availability of its products, including the launch of Vibativ in Saudi Arabia and regulatory approval for ibuprofen injection in Mexico[101]. - Cumberland's ifetroban clinical trial for Duchenne muscular dystrophy (DMD) showed a 3.3% overall improvement in left ventricular ejection fraction (LVEF) with high-dose treatment[110]. - The company is actively developing a pipeline of new product candidates, including ongoing Phase II clinical programs for ifetroban in systemic sclerosis and idiopathic pulmonary fibrosis[108]. Financial Position and Liquidity - As of September 30, 2025, the company held approximately $52.6 million in federal net operating loss carryforwards, expected to offset future income tax obligations[145]. - The company had a working capital of $5.6 million as of September 30, 2025, compared to $4.8 million at the end of 2024, indicating improved liquidity[149]. - The Company entered into a new Revolving Credit Loan Agreement with Pinnacle Bank for up to $25 million, with an initial line of credit of $20 million and a three-year term expiring on October 1, 2026[153]. - The interest rate for the revolving credit facility is based on Term SOFR plus 2.75%, with the applicable interest rate at 7.0% as of September 30, 2025[158]. - As of September 30, 2025, the Company had $5.2 million in borrowings outstanding under the revolving credit facility[158]. - The Company does not engage in off-balance sheet arrangements during the nine months ended September 30, 2025 and 2024[155]. - The Company believes its interest rate risk related to cash and cash equivalents is not material, with minimal exposure to significant downside risk[157]. - Foreign currency exchange gains and losses were immaterial for the nine months ended September 30, 2025 and 2024, with a maximum exposure of 90 days based on invoice terms[159]. - The Company does not utilize financial instruments to hedge exposure to foreign currency fluctuations, believing the exposure is minimal[159]. - The interest rate risk related to borrowings under the line of credit has a minimum Term SOFR of 0.90%[158]. - The Company has an alternative financial covenant that allows for a maximum revolver amount based on cash balances and eligible accounts receivable[154]. - The Company aims to preserve principal while maximizing interest income through low-risk investments[156]. Management and Governance - Cumberland's management team consists of industry veterans with expertise in various areas, including business development and regulatory affairs[92]. - The company emphasizes financial discipline, aiming to maintain favorable gross margins and a strong balance sheet while managing expenses in line with revenues[97].

Financial Data and Key Metrics Changes - For Q3 2025, net revenue from continuing operations was $8.3 million, with year-to-date revenues totaling $30.9 million, reflecting a 12% growth compared to the same period last year [10][23] - The adjusted loss for Q3 was $0.8 million, or $0.06 per share, while year-to-date adjusted earnings were $1.9 million, or $0.13 per share [10][23] - Cash flow from operations increased to nearly $5 million through September 2025 [10][23] Business Line Data and Key Metrics Changes - Revenue breakdown for Q3 2025 included $1.2 million for Kristalose, $3.2 million for Sancuso, $2.6 million for Vibativ, and $0.9 million for Caldolor [23] - Year-to-date product revenues were $7.4 million for Kristalose, $8.6 million for Sancuso, $6.7 million for Vibativ, and $3.8 million for Caldolor [23] Market Data and Key Metrics Changes - The company launched Vibativ in Saudi Arabia and received regulatory approval for ibuprofen injection in Mexico, expanding its international presence [8][9] - Vibativ was added to a national purchasing agreement with Premier Inc., enhancing its market accessibility [15] Company Strategy and Development Direction - The company entered a joint commercialization agreement with RedHill Biopharma for Talicia, a treatment for H. pylori infections, which is expected to contribute significantly to revenue [5][6] - The company is focused on expanding its portfolio of FDA-approved brands and enhancing its clinical pipeline, particularly with the Ifetroban product candidate [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's future, highlighting the addition of new products and the expected momentum across approved brands [28] - The company anticipates increased international contributions and further progress in its clinical pipeline [28] Other Important Information - The company reported total assets of $66 million, including $15 million in cash, and total liabilities of $40 million at the end of Q3 [11][25] - The company continues to hold over $53 million in tax net operating loss carryforwards [26] Q&A Session Summary - There were no questions during the Q&A session, and management encouraged shareholders to reach out for private discussions if desired [31][32]

Financial Performance - Year-to-date revenues for Cumberland Pharmaceuticals in 2025 totaled $30.8 million, representing a 12% increase compared to the first nine months of 2024[2] - For Q3 2025, net revenues were $8.3 million, including $1.2 million from Kristalose, $3.2 million from Sancuso, $2.6 million from Vibativ, and $0.9 million from Caldolor[17] - The company reported a year-to-date net loss of approximately $1.4 million and a Q3 net loss of approximately $1.9 million[18] - Net revenues for Q3 2025 were $8.29 million, a decrease of 8.7% compared to $9.09 million in Q3 2024[39] - The net loss attributable to common shareholders for Q3 2025 was $1.94 million, compared to a loss of $1.54 million in Q3 2024, reflecting an increase in losses of 25.7%[39] - For the nine months ended September 30, 2025, the net loss attributable to common shareholders was $1,424,436, or $0.09 per share, compared to a net loss of $4,575,956, or $0.32 per share for the same period in 2024[45] - Adjusted diluted earnings for the nine months ended September 30, 2025, were $1,918,675, or $0.13 per share, compared to an adjusted loss of $720,032, or $0.05 per share for the same period in 2024[45] Assets and Liabilities - Cumberland ended Q3 2025 with approximately $66 million in total assets, $40 million in liabilities, and $26 million in shareholders' equity[3] - Total assets decreased to $65.90 million as of September 30, 2025, down from $75.58 million at the end of 2024, representing a decline of 13.0%[37] - Total liabilities decreased to $40.10 million as of September 30, 2025, down from $53.04 million at the end of 2024, a reduction of 24.4%[37] - Cash and cash equivalents at the end of Q3 2025 were $15.20 million, down from $17.96 million at the beginning of the period, indicating a decrease of 15.5%[41] Clinical Developments - The Phase II FIGHT DMD trial for ifetroban showed a 5.4% improvement in cardiac function in patients with Duchenne muscular dystrophy[13] - Cumberland has ongoing clinical studies for ifetroban in patients with Systemic Sclerosis and Idiopathic Pulmonary Fibrosis[15][16] Partnerships and Product Launches - Cumberland announced a partnership with RedHill Biopharma to jointly commercialize Talicia, with Cumberland investing $4 million for a 30% ownership stake in the new company, Talicia Holdings, Inc.[5] - Vibativ was launched in Saudi Arabia through an agreement with Tabuk Pharmaceutical Manufacturing Company, which has exclusive distribution rights in Saudi Arabia and Jordan[8] - Cumberland's ibuprofen injection product received regulatory approval in Mexico, with PiSA Farmaceutica responsible for its registration and commercialization[8] Financial Adjustments and Management Insights - The adjusted loss for Q3 2025 was $0.8 million, or $0.06 per share, while adjusted earnings for the first nine months were $1.9 million, or $0.13 per diluted share[18] - Management emphasizes the importance of adjusted financial measures as they provide insight into the company's operating performance excluding non-core items[48] - The company utilizes net operating loss carryforwards to minimize income tax expenses, reflecting a strategic approach to financial management[48] - Adjusted earnings are defined as net income (loss) adjusted for income taxes, depreciation, amortization, share-based compensation, interest income, and interest expense[49] - The company believes that presenting supplemental financial measures offers greater transparency and consistency in evaluating operating performance across reporting periods[48] - Management encourages investors to review the complete consolidated financial statements for a comprehensive understanding of the company's financial position[47]

Core Insights - Cumberland Pharmaceuticals Inc. reported combined net revenues of $8.3 million for Q3 2025, with year-to-date revenues reaching $30.8 million, a 12% increase compared to the same period in 2024 [1][17][18] Financial Performance - Total operating expenses for Q3 2025 were $10.3 million, leading to a net loss of approximately $1.9 million for the quarter and a year-to-date net loss of about $1.4 million [18][19] - The company ended Q3 2025 with total assets of approximately $66 million, liabilities of $40 million, and shareholders' equity of $26 million [2][19] Product Portfolio and Developments - Cumberland added Talicia, an FDA-approved product for treating H. pylori infection, to its commercial portfolio through a partnership with RedHill Biopharma [4][5] - The company has formed Talicia Holdings, Inc., with RedHill holding a 70% ownership stake, while Cumberland invests $4 million over two years for a 30% stake [5][6] - Talicia is now recommended as a first-line therapy in clinical guidelines and is patent protected until 2042 [7] International Expansion - Cumberland launched Vibativ in Saudi Arabia through an agreement with Tabuk Pharmaceutical, which has exclusive distribution rights in Saudi Arabia and Jordan [8][9] - The company also received regulatory approval for its ibuprofen injection product in Mexico and Vibativ in China [9] Clinical Trials and Research - Cumberland's ifetroban product candidate showed a 5.4% improvement in cardiac function in a Phase II trial for Duchenne muscular dystrophy [13][14] - The company is also conducting Phase II trials for ifetroban in systemic sclerosis and idiopathic pulmonary fibrosis [15][16]

Core Viewpoint - Cumberland Pharmaceuticals Inc. is set to release its third quarter 2025 financial results and provide a company update on November 4, 2025, after market close [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][4] - The company has a portfolio of FDA-approved brands including Acetadote, Caldolor, Kristalose, Sancuso, Vaprisol, and Vibativ, which address various medical needs such as acetaminophen poisoning, pain and fever, constipation, chemotherapy-induced nausea, hyponatremia, and serious bacterial infections [5] Clinical Programs - The company is currently conducting Phase II clinical programs to evaluate its ifetroban product candidate for conditions such as Systemic Sclerosis, cardiomyopathy associated with Duchenne Muscular Dystrophy, and Idiopathic Pulmonary Fibrosis [4]