Core Insights - Cumberland Pharmaceuticals Inc. has announced a strategic partnership with RedHill Biopharma Ltd. to jointly commercialize Talicia, an FDA-approved therapy for Helicobacter pylori infection, which is a significant risk factor for gastric cancer [1][2][3] Company Overview - Cumberland Pharmaceuticals is a specialty pharmaceutical company focused on improving patient care through high-quality products, with a portfolio that includes various FDA-approved brands [7] - RedHill Biopharma is a specialty biopharmaceutical company primarily focused on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology [9] Partnership Details - The agreement involves forming a new jointly owned company where RedHill will contribute all Talicia assets, including international licenses and revenues, while Cumberland will invest $4 million and manage distribution and sales [2][4] - Talicia generated net revenues of $8 million in 2024, and both companies will share these revenues equally while collaborating on operational aspects such as sales, marketing, and supply chain [2][4] Product Information - Talicia is a unique all-in-one oral capsule combining omeprazole, amoxicillin, and rifabutin, with a high eradication rate of over 90%, simplicity of use, and low resistance [3][6] - The product is recognized as a first-line treatment option in the updated American College of Gastroenterology guidelines for H. pylori infections [3] Market Position - Talicia is patent-protected until 2042 and has received eight years of U.S. market exclusivity under the Qualified Infectious Disease Product (QIDP) designation [4][6] - The product has broad U.S. insurance coverage, with 70% of American lives covered by commercial plans and 60% by government plans, and is available at 1,700 CVS pharmacies [5]

Core Insights - Cumberland Pharmaceuticals Inc. has added its antibiotic Vibativ (telavancin) to a national group purchasing agreement with Premier, Inc., effective October 1, 2025, allowing Premier members to access special pricing and terms for the product [1][4] Group 1: Product Details - Vibativ is a once-daily, dual mechanism antibiotic effective against serious Gram-positive bacterial infections, including hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and complicated skin and skin structure infections (cSSSI) [4][8] - The product is available in two packaging options: a standard 12-vial carton for high patient volume institutions and a new 4-vial Starter Pak designed for cost-effective therapy initiation and inventory management [2][4] Group 2: Market Context - Premier, a leading healthcare improvement company, unites approximately 4,350 U.S. hospitals and 325,000 other providers, enabling better care and outcomes at lower costs through integrated data and analytics, supply chain solutions, and consulting services [3] - The addition of Vibativ to Premier's offerings enhances access for healthcare providers, supporting both inpatient and outpatient settings [2][4] Group 3: Efficacy and Resistance - Vibativ was specifically designed to combat drug-resistant bacteria, with modifications that enhance its ability to penetrate bacterial cell walls and tissues, making it effective against infections that are difficult to treat [6][10] - Studies indicate that Vibativ maintains its potency against multidrug-resistant bacteria, demonstrating higher cure rates compared to vancomycin in treating HABP/VABP [7][10][11]

Core Viewpoint - Cumberland Pharmaceuticals has received regulatory approval for its injectable ibuprofen product in Mexico, highlighting the increasing demand for effective non-opioid pain management solutions [1][3]. Company Overview - Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company based in Tennessee, focused on developing and commercializing unique products for hospital acute care, gastroenterology, and oncology markets [5]. Product Details - The newly approved injectable ibuprofen is designed for intravenous delivery to manage pain and reduce fever in hospital and surgical settings, significantly reducing post-operative pain and the need for opioid medications [3][4]. - The product will be available in 800 mg vials, making it suitable for various clinical applications in Mexican healthcare facilities [4]. Partnership and Market Strategy - Cumberland has partnered with PiSA Farmaceutica, which holds exclusive supply and distribution rights for the ibuprofen product in Mexico. PiSA will lead the regulatory process and product launch [2][4]. - This collaboration aims to address the global challenges of opioid misuse by supporting multimodal, opioid-sparing pain management strategies [4].

Core Viewpoint - The launch of Cumberland's Vibativ (telavancin) injection in Saudi Arabia represents a significant advancement in the treatment of serious infections, particularly those caused by multidrug-resistant bacteria, addressing a critical need in the region [2][4][6]. Company Overview - Tabuk Pharmaceutical Manufacturing Company, a subsidiary of Astra Industrial Group, is a leading pharmaceutical company in the Middle East, responsible for the registration and promotion of Vibativ in Saudi Arabia and other Middle Eastern countries [2][11]. - Cumberland Pharmaceuticals Inc. is a biopharmaceutical company based in Tennessee, focused on developing and commercializing unique products for hospital acute care, gastroenterology, and oncology [12]. Product Details - Vibativ is an FDA-approved injectable antibiotic designed to treat hospital-acquired and ventilator-associated pneumonia, as well as complicated skin infections caused by Gram-positive bacteria, including MRSA and MSSA [3][9]. - The drug is administered intravenously with once-daily dosing and does not require therapeutic drug monitoring, which reduces healthcare professionals' exposure to patients [3][4]. - Vibativ was specifically engineered to combat drug-resistant bacteria, enhancing its efficacy against difficult-to-treat infections [5][6]. Market Context - The global rise in antimicrobial resistance (AMR) poses a significant threat to public health, making Vibativ a crucial addition to the anti-infective portfolio in the Middle East [4][5]. - Studies indicate that Vibativ maintains its potency against multidrug-resistant bacteria, demonstrating higher cure rates compared to vancomycin in treating Gram-positive infections [9][10]. Strategic Importance - The partnership between Tabuk and Cumberland aims to expand the reach of Vibativ, ensuring that it is accessible to patients in Saudi Arabia, thereby addressing urgent healthcare needs in the region [6][11].

[PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This section presents the unaudited condensed consolidated financial statements and management's analysis of financial condition [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) This section presents the unaudited condensed consolidated financial statements and their accompanying notes, detailing the company's financial position, performance, and cash flows [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position at June 30, 2025, and December 31, 2024 | Metric | June 30, 2025 | December 31, 2024 | Change (%) | | :-------------------------- | :-------------- | :---------------- | :--------- | | Cash and cash equivalents | $16,087,281 | $17,964,184 | -10.45% | | Total current assets | $31,205,329 | $36,452,158 | -14.39% | | Total assets | $67,907,149 | $75,583,410 | -10.16% | | Total current liabilities | $23,972,140 | $31,621,729 | -24.20% | | Total liabilities | $40,228,222 | $53,037,433 | -24.15% | | Total shareholders' equity | $27,989,795 | $22,853,494 | +22.40% | | Total equity | $27,678,927 | $22,545,977 | +22.77% | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details the company's financial performance for the three and six months ended June 30, 2025 and 2024 Three Months Ended June 30 (YoY Comparison) | Metric | 2025 | 2024 | Change (%) | | :----- | :------------ | :------------ | :--------- | | Net revenues | $10,837,363 | $9,848,849 | +10.03% | | Total costs and expenses | $11,584,841 | $10,875,537 | +6.52% | | Operating income (loss) | $(747,478) | $(1,026,688) | +27.21% | | Net income (loss) | $(735,207) | $(1,102,637) | +33.32% | | Basic EPS | $(0.05) | $(0.08) | +37.50% | Six Months Ended June 30 (YoY Comparison) | Metric | 2025 | 2024 | Change (%) | | :----- | :------------ | :------------ | :--------- | | Net revenues | $22,550,418 | $18,346,550 | +22.91% | | Total costs and expenses | $22,005,949 | $21,242,488 | +3.59% | | Operating income (loss) | $544,469 | $(2,895,938) | +118.80% |\ | Net income (loss) | $512,977 | $(3,005,109) | +117.07% | | Basic EPS | $0.03 | $(0.21) | +114.29% | [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section outlines the company's cash inflows and outflows from operating, investing, and financing activities Six Months Ended June 30 (YoY Comparison) | Cash Flow Activity | 2025 | 2024 | Change ($) | | :----------------- | :------------ | :------------ | :--------- | | Operating activities | $4,742,318 | $(2,992,307) | +$7,734,625 |\ | Investing activities | $(942,322) | $(104,990) | -$837,332 |\ | Financing activities | $(5,676,899) | $2,112,119 | -$7,789,018 |\ | Net decrease in cash and cash equivalents | $(1,876,903) | $(985,178) | -$891,725 | [Condensed Consolidated Statements of Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Equity) This section presents changes in shareholders' equity for the six months ended June 30, 2025 Equity Changes (December 31, 2024 to June 30, 2025) | Metric | December 31, 2024 | June 30, 2025 | Change ($) | | :-------------------------- | :---------------- | :------------ | :--------- | | Common stock (Amount) | $46,821,425 | $51,441,398 | +$4,619,973 |\ | Accumulated deficit | $(23,967,931) | $(23,451,603) | +$516,328 |\ | Noncontrolling interests | $(307,517) | $(310,868) | -$3,351 |\ | Total equity | $22,545,977 | $27,678,927 | +$5,132,950 | - Share issuances contributed **$4,715,950** to common stock during the six months ended March 31, 2025, while share repurchases reduced common stock by **$243,704** in the same period and **$7,170** in the subsequent quarter. Share-based compensation added **$74,212** and **$80,685** respectively[16](index=16&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [(1) Organization and Basis of Presentation](index=8&type=section&id=%281%29%20ORGANIZATION%20AND%20BASIS%20OF%20PRESENTATION) This note describes the company's business, operating segment, and the basis for preparing its interim financial statements - Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on branded prescription pharmaceuticals for hospital acute care, gastroenterology, and oncology markets[19](index=19&type=chunk)[20](index=20&type=chunk) - The company operates as a single operating segment, with substantially all assets and revenues attributable to U.S. customers[28](index=28&type=chunk) - Recent accounting guidance ASU 2023-07 (Segment Reporting) had no material impact due to the company's single segment. ASU 2023-09 (Income Tax Disclosures) and ASU 2024-03 (Expense Disaggregation) are effective in 2025 and 2026/2027 respectively, and their impact is currently being assessed[24](index=24&type=chunk)[25](index=25&type=chunk)[26](index=26&type=chunk) - The company applies Current Expected Credit Losses (CECL) to financial instruments, primarily trade and notes receivables, pooling assets based on similar risk characteristics. Historically, there have been virtually no write-downs of receivables due to reliable payments from large pharmaceutical, healthcare, or government customers[29](index=29&type=chunk)[31](index=31&type=chunk) [(2) Earnings (Loss) Per Share](index=11&type=section&id=%282%29%20EARNINGS%20%28LOSS%29%20PER%20SHARE) This note reconciles the numerator and denominator for basic and diluted earnings per share calculations EPS Reconciliation (Three Months Ended June 30) | Metric | 2025 | 2024 | | :----------------------------------- | :------------ | :------------ | | Net loss attributable to common shareholders | $(740,740) | $(1,085,612) | | Weighted-average shares outstanding – basic | 14,960,596 | 14,118,091 | | Weighted-average shares outstanding – diluted | 14,960,596 | 14,118,091 | EPS Reconciliation (Six Months Ended June 30) | Metric | 2025 | 2024 | | :----------------------------------- | :------------ | :------------ | | Net income (loss) attributable to common shareholders | $516,328 | $(3,031,875) | | Weighted-average shares outstanding – basic | 14,951,609 | 14,107,852 | | Dilutive effect of other securities | 322,525 | — | | Weighted-average shares outstanding – diluted | 15,274,134 | 14,107,852 | - As of June 30, 2025, **753,089** restricted stock awards and options were outstanding but excluded from diluted EPS calculation due to their antidilutive effect, except for the six months ended June 30, 2025, where a dilutive effect of **322,525** shares was recognized[33](index=33&type=chunk) [(3) Revenues](index=12&type=section&id=%283%29%20REVENUES) This note details the company's net revenues by product and other sources for the reported periods Net Revenues by Product (Three Months Ended June 30) | Product | 2025 | 2024 | Change ($) | Change (%) | | :-------- | :------------ | :------------ | :------------ | :--------- | | Kristalose | $2,754,299 | $4,107,834 | $(1,353,535) | -32.95% | | Sancuso | $3,119,110 | $2,188,776 | $930,334 | +42.49% | | Vibativ | $2,701,854 | $2,454,481 | $247,373 | +10.08% | | Caldolor | $1,588,293 | $844,248 | $744,045 | +88.13% | | Acetadote | $193,546 | $43,396 | $150,150 | +346.00% | | Vaprisol | $(14,621) | $(1,581) | $(13,040) | -824.79% | | Other revenue | $492,390 | $213,792 | $278,598 | +130.31% | | **Total Net Revenues** | **$10,837,363** | **$9,848,849** | **$988,514** | **+10.03%** | Net Revenues by Product (Six Months Ended June 30) | Product | 2025 | 2024 | Change ($) | Change (%) | | :-------- | :------------ | :------------ | :------------ | :--------- | | Kristalose | $6,238,609 | $7,303,444 | $(1,064,835) | -14.58% | | Sancuso | $5,375,405 | $4,016,544 | $1,358,861 | +33.83% | | Vibativ | $4,079,920 | $4,059,970 | $19,950 | +0.49% | | Caldolor | $2,895,733 | $2,314,947 | $580,786 | +25.09% | | Acetadote | $345,195 | $123,599 | $221,596 | +179.29% | | Vaprisol | $(15,221) | $7,081 | $(22,302) | -314.95% | | Other revenue | $3,634,019 | $489,121 | $3,144,898 | +642.96% | | **Total Net Revenues** | **$22,550,418** | **$18,346,550** | **$4,203,868** | **+22.91%** | - Other revenues for the six months ended June 30, 2025, included a **$3.0 million** milestone payment for Vibativ's approval in the Chinese market and **$0.2 million** in development funding for a new product[41](index=41&type=chunk)[42](index=42&type=chunk) - Omeclamox-Pak sales were discontinued in late 2023 due to packaging issues, and Vaprisol sales were impacted by a manufacturing transition awaiting FDA approval[35](index=35&type=chunk)[36](index=36&type=chunk) [(4) Inventories](index=14&type=section&id=%284%29%20INVENTORIES) This note provides a breakdown of inventory composition and valuation, including current and non-current classifications Inventory Composition | Inventory Type | June 30, 2025 | December 31, 2024 | | :----------------------- | :-------------- | :---------------- | | Raw materials and work in process | $10,376,276 | $11,982,045 | | Consigned inventory | $114,045 | $126,090 | | Finished goods | $2,258,673 | $2,897,359 | | **Total inventories** | **$12,748,994** | **$15,005,494** | | Less non-current inventories | $(9,526,122) | $(11,005,499) | | **Total inventories classified as current** | **$3,222,872** | **$3,999,995** | Non-Current Inventories by Product | Product Raw Materials/Finished Goods | June 30, 2025 | December 31, 2024 | | :----------------------------------- | :-------------- | :---------------- | | Vibativ Raw Materials | $4,981,627 | $6,180,347 | | Kristalose Raw Materials | $2,576,128 | $2,672,720 | | Vaprisol Raw Materials | $1,172,849 | $1,172,849 | | Sancuso Raw Materials | $326,124 | $458,684 | | Caldolor Raw Materials | $13,971 | — | | Acetadote Raw Materials | — | $23,915 | | Ifetroban Raw Materials | $65,270 | $166,923 | | Vibativ Finished Goods | $157,645 | $183,057 | | Caldolor Finished Goods | $162,886 | $77,382 | | Omeclamox | $69,622 | $69,622 | | **Total non-current inventories** | **$9,526,122** | **$11,005,499** | - The company continually evaluates inventory for obsolescence, with no cumulative net realizable value charges necessary at June 30, 2025, or December 31, 2024[44](index=44&type=chunk) [(5) Leases](index=15&type=section&id=%285%29%20LEASES) This note details the company's operating lease arrangements, including right-of-use assets and lease liabilities Lease Assets and Liabilities | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :-------------- | :---------------- | | Operating lease right-of-use assets | $7,125,408 | $6,176,923 | | Operating lease current liabilities | $386,077 | $356,508 | | Operating lease non-current liabilities | $4,714,183 | $4,939,739 | | **Total lease liabilities** | **$5,100,260** | **$5,296,247** | - The weighted-average remaining lease term for the Broadwest and Gateway Leases is **9.2 years** at June 30, 2025, with a weighted-average incremental borrowing rate of **9.37%**[52](index=52&type=chunk) Rent Expense and Sublease Income (Three and Six Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--------- | :------------ | :------------ | :------------ | :------------ | | Rent expense | $363,583 | $344,418 | $718,335 | $699,482 | | Sublease income | $162,797 | $123,230 | $321,426 | $287,913 | [(6) Shareholders' Equity and Debt](index=18&type=section&id=%286%29%20SHAREHOLDERS%27%20EQUITY%20AND%20DEBT) This note outlines changes in shareholders' equity, share repurchase programs, and debt obligations - The company has a **$10 million** share repurchase program, with approximately **$2.2 million** available as of June 30, 2025. During the six months ended June 30, 2025, **55,637** shares were repurchased for **$0.3 million**[55](index=55&type=chunk) - In February 2025, the company issued **1,000,000** shares through an ATM offering for **$5.5 million**, and subsequently increased the maximum gross sales price under the ATM program to **$10 million**[57](index=57&type=chunk) - Share-based compensation expense was **$0.2 million** for both the six months ended June 30, 2025 and 2024[59](index=59&type=chunk) - As of June 30, 2025, the company had **$5.2 million** in borrowings outstanding under its **$25 million** revolving credit facility with Pinnacle Bank, at an interest rate of **7.125%**[60](index=60&type=chunk)[62](index=62&type=chunk) [(7) Income Taxes](index=19&type=section&id=%287%29%20INCOME%20TAXES) This note discusses the company's net operating loss carryforwards and the impact of recent tax legislation - As of June 30, 2025, the company has approximately **$51.9 million** in federal net operating loss carryforwards, including **$44.1 million** from nonqualified stock options, which are expected to minimize future income tax obligations[64](index=64&type=chunk) - The recently enacted One Big Beautiful Bill Act (OBBBA) in the U.S. includes significant tax provisions, and the company is currently assessing its impact on financial statements[65](index=65&type=chunk) [(8) Collaborative Agreements](index=19&type=section&id=%288%29%20COLLABORATIVE%20AGREEMENTS) This note describes the company's collaborative arrangements and their accounting treatment - Collaborative agreements with research institutions are primarily funded by SBIR/STTR programs and grants[66](index=66&type=chunk) - Most collaborative agreements do not meet ASC Topic 808 criteria, with expenses included in R&D and grant funding in net revenues[66](index=66&type=chunk) [(9) Commitments and Contingencies](index=19&type=section&id=%289%29%20COMMITMENTS%20AND%20CONTINGENCIES) This note addresses the company's involvement in litigation and its expected financial impact - The company is involved in normal course litigation but does not expect a material adverse effect on its business or financial condition[67](index=67&type=chunk) [(10) Product Acquisitions and Return of Product Rights](index=20&type=section&id=%2810%29%20PRODUCT%20ACQUISITIONS%20AND%20RETURN%20OF%20PRODUCT%20RIGHTS) This note details the accounting for product acquisitions and the return of product rights, including contingent consideration - Vibativ was acquired in November 2018, including global rights, for an upfront payment of **$20 million** and a **$5 million** milestone payment, with ongoing royalties up to **20%** of net sales[68](index=68&type=chunk)[69](index=69&type=chunk) Vibativ Contingent Consideration Liability | Metric | Amount ($) | | :---------------------------------------------------- | :--------- | | Balance at December 31, 2024 | 3,242,999 | | Cash payment of royalty during the period | (273,028) | | Change in fair value of contingent consideration included in operating expenses | 201,431 | | Contingent consideration earned and accrued in operating expenses | 230,484 | | **Balance at June 30, 2025** | **3,401,886** | - Sancuso U.S. rights were acquired in January 2022 for a **$13.5 million** upfront payment and up to **$3.5 million** in milestone payments, with ongoing royalties up to **10%** of net sales[73](index=73&type=chunk)[76](index=76&type=chunk)[78](index=78&type=chunk) Sancuso Contingent Consideration Liability | Metric | Amount ($) | | :---------------------------------------------------- | :--------- | | Balance at December 31, 2024 | 1,516,000 | | Cash payment of milestones and royalty during the period | (381,729) | | Change in fair value of contingent consideration included in operating expenses | (117,853) | | Contingent consideration earned and accrued in operating expenses | 289,582 | | **Balance at June 30, 2025** | **1,306,000** | - The company returned all U.S. rights to RediTrex to Nordic Group B.V. effective June 30, 2023, and will receive a long-term royalty on future sales[81](index=81&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, results of operations, and future outlook [Disclosure regarding forward-looking statements](index=22&type=section&id=Disclosure%20regarding%20forward-looking%20statements) This section cautions that the discussion contains forward-looking statements subject to inherent risks and uncertainties - The discussion contains forward-looking statements subject to risks and uncertainties, and actual results may differ materially. The company does not undertake to publicly update or revise these statements[82](index=82&type=chunk) [Overview of Business](index=23&type=section&id=OVERVIEW) This section provides a general description of the company's specialty pharmaceutical business and product portfolio - Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on acquiring, developing, and commercializing branded prescription pharmaceuticals, targeting hospital acute care, gastroenterology, and oncology[84](index=84&type=chunk)[85](index=85&type=chunk) - The company's portfolio includes six FDA-approved commercial brands: Acetadote, Caldolor, Kristalose, Sancuso, Vaprisol, and Vibativ[90](index=90&type=chunk) - Cumberland has ongoing Phase II clinical programs for ifetroban in Duchenne muscular dystrophy (DMD), Systemic Sclerosis (SSc), and Idiopathic Pulmonary Fibrosis (IPF)[86](index=86&type=chunk)[87](index=87&type=chunk) [Growth Strategy](index=24&type=section&id=GROWTH%20STRATEGY) This section outlines the company's strategic initiatives for maximizing existing brands and expanding its product pipeline - The growth strategy focuses on maximizing existing brands, building a differentiated product portfolio through acquisitions, progressing clinical pipelines (e.g., ifetroban), leveraging infrastructure via co-promotion, expanding international presence, and maintaining financial discipline[91](index=91&type=chunk)[92](index=92&type=chunk) - Key initiatives include expanding product labeling (Acetadote, Caldolor), acquiring under-promoted FDA-approved drugs or late-stage development candidates (e.g., Vibativ, Sancuso), and incubating early-stage products through Cumberland Emerging Technologies (CET)[92](index=92&type=chunk) [Recent Developments](index=25&type=section&id=RECENT%20DEVELOPMENTS) This section highlights key recent events, including clinical trial progress, product approvals, and strategic partnerships - Breakthrough findings from the Phase II FIGHT DMD trial for ifetroban showed a **5.4%** improvement in cardiac function in DMD patients, positioning it as a potential treatment for DMD cardiomyopathy. An end-of-Phase 2 meeting with the FDA is scheduled for Fall 2025[93](index=93&type=chunk)[94](index=94&type=chunk) - Enrollment for the Phase II ifetroban study in Systemic Sclerosis (scleroderma) is complete, with top-line findings expected later this year. Patient enrollment is also underway for the FIGHTING FIBROSIS™ trial in Idiopathic Pulmonary Fibrosis (IPF)[95](index=95&type=chunk)[96](index=96&type=chunk) - The Vibativ 4-Vial Starter Pak is now available to Vizient Inc. healthcare providers, expanding access to the product. A new pharmacokinetic analysis reinforces optimized dosing strategies for Vibativ[98](index=98&type=chunk)[99](index=99&type=chunk)[100](index=100&type=chunk) - A study published in Clinical Therapeutics demonstrated Caldolor's safety and efficacy for managing post-operative pain in older patients (60+), showing a **24%** reduction in pain at rest and a **23.2%** reduction in morphine requirement compared to placebo[101](index=101&type=chunk)[102](index=102&type=chunk) - Cumberland partnered with Qureight Ltd. to use AI-enhanced image analytics for the FIGHTING FIBROSIS™ trial, aiming for deeper insights into treatment efficacy and disease progression in IPF[104](index=104&type=chunk)[105](index=105&type=chunk) - Vibativ received regulatory approval in China, and Tabuk Pharmaceutical has obtained final approvals to commercialize Vibativ in Saudi Arabia, with shipments and training completed in late 2024[106](index=106&type=chunk)[107](index=107&type=chunk) [Competition](index=27&type=section&id=Competition) This section discusses the competitive landscape within the pharmaceutical industry and specific product competition - The pharmaceutical industry is highly competitive, with competition from other branded products, generics, and alternate medical treatments[108](index=108&type=chunk) - Kristalose faces competition from branded prescription products like Amitiza, Movantik, Linzess, and Vibrant, hundreds of OTC products (e.g., MiraLax), and other lactulose products including generics. A new generic crystalline lactulose product became available in Q2 2025[109](index=109&type=chunk) [Tariffs](index=27&type=section&id=Tariffs) This section addresses potential impacts of trade policies and tariffs on pharmaceutical imports - The U.S. Department of Commerce initiated a Section 232 investigation into pharmaceutical imports, which could lead to additional tariffs. A trade deal with the EU in July 2025 imposed a **15%** tariff on imported medicines from Europe into the U.S[111](index=111&type=chunk)[112](index=112&type=chunk) [Summary](index=27&type=section&id=Summary) This section provides a concise overview of the company's anticipated future performance and strategic focus - The company anticipates continued momentum driven by growth from approved brands, expanded international partnerships, progress in clinical development programs, and potential acquisitions, while remaining focused on its mission[113](index=113&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=29&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES%20AND%20SIGNIFICANT%20JUDGMENTS%20AND%20ESTIMATES) This section outlines the key accounting policies and estimates that require significant management judgment - Key estimates include allowances for chargebacks, rebates, product returns, obsolescent inventory, and valuation of contingent consideration liabilities associated with business combinations[116](index=116&type=chunk) [Results of Operations (Three Months Ended June 30, 2025 vs. 2024)](index=30&type=section&id=RESULTS%20OF%20OPERATIONS%20%28Three%20months%20ended%20June%2030,%202025%20compared%20to%20the%20three%20months%20ended%20June%2030,%202024%29) This section analyzes the company's financial performance for the three months ended June 30, 2025, compared to the prior year Key Financials (Three Months Ended June 30) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------- | :------------ | :------------ | :------------ | :--------- | | Net revenues | $10,837,363 | $9,848,849 | $988,514 | +10.03% | | Cost of products sold | $2,011,389 | $1,710,944 | $300,445 | +17.56% | | Selling and marketing | $4,223,647 | $4,248,401 | $(24,754) | -0.58% | | Research and development | $1,468,399 | $1,059,187 | $409,212 | +38.63% | | General and administrative | $2,874,922 | $2,757,148 | $117,774 | +4.27% | | Amortization | $1,006,484 | $1,099,857 | $(93,373) | -8.49% | | Operating loss | $(747,478) | $(1,026,688) | $279,210 | +27.21% | | Net loss | $(735,207) | $(1,102,637) | $367,430 | +33.32% | - Net revenues increased primarily due to higher sales volumes for Sancuso (+$0.9M), Caldolor (+$0.7M, driven by international sales), Vibativ (+$0.2M), and Acetadote (+$0.2M), partially offset by a decrease in Kristalose sales (-$1.4M)[118](index=118&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk) - Cost of products sold increased by **17.56%**, and as a percentage of net revenues, rose from **17.4%** to **18.6%**, primarily due to higher international sales which typically incur higher cost of goods sold relative to revenue[123](index=123&type=chunk) - Research and development costs increased by **38.63%** due to variable costs associated with ongoing clinical initiatives for pipeline product candidates[125](index=125&type=chunk) Vibativ and Sancuso Contribution (Three Months Ended June 30) | Metric | Vibativ 2025 | Vibativ 2024 | Sancuso 2025 | Sancuso 2024 | | :------------------------ | :----------- | :----------- | :----------- | :----------- | | Net revenue | $2,701,854 | $2,454,481 | $3,119,110 | $2,188,776 | | Cost of products sold | $640,676 | $549,583 | $153,728 | $299,547 | | Royalty and operating expenses | $673,693 | $600,007 | $1,010,904 | $1,002,354 | | Contribution | $1,387,485 | $1,304,891 | $1,954,478 | $886,875 | [Results of Operations (Six Months Ended June 30, 2025 vs. 2024)](index=33&type=section&id=RESULTS%20OF%20OPERATIONS%20%28Six%20months%20ended%20June%2030,%202025%20compared%20to%20the%20six%20months%20ended%20June%2030,%202024%29) This section analyzes the company's financial performance for the six months ended June 30, 2025, compared to the prior year Key Financials (Six Months Ended June 30) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------- | :------------ | :------------ | :------------ | :--------- | | Net revenues | $22,550,418 | $18,346,550 | $4,203,868 | +22.91% | | Cost of products sold | $3,437,103 | $3,286,486 | $150,617 | +4.58% | | Selling and marketing | $8,455,627 | $8,402,989 | $52,638 | +0.63% | | Research and development | $2,763,475 | $2,217,440 | $546,035 | +24.62% | | General and administrative | $5,337,930 | $5,125,055 | $212,875 | +4.15% | | Amortization | $2,011,814 | $2,210,518 | $(198,704) | -8.99% | | Operating income (loss) | $544,469 | $(2,895,938) | $3,440,407 | +118.80% | | Net income (loss) | $512,977 | $(3,005,109) | $3,518,086 | +117.07% | - Net revenues increased significantly, driven by a **$3.0 million** milestone payment in 'Other revenue' and increased sales of Sancuso (+$1.4M) and Caldolor (+$0.6M), partially offset by decreased Kristalose sales (-$1.1M)[131](index=131&type=chunk)[133](index=133&type=chunk)[135](index=135&type=chunk) - Research and development costs increased by **24.62%** due to continued funding of ongoing clinical initiatives for pipeline product candidates[137](index=137&type=chunk) - Amortization expense decreased by **8.99%** due to a reduction in the valuation of the Acetadote intangible asset recognized in December 2024[139](index=139&type=chunk) Vibativ and Sancuso Contribution (Six Months Ended June 30) | Metric | Vibativ 2025 | Vibativ 2024 | Sancuso 2025 | Sancuso 2024 | | :------------------------ | :----------- | :----------- | :----------- | :----------- | | Net revenue | $7,054,920 | $4,059,970 | $5,375,405 | $4,016,544 | | Cost of products sold | $889,117 | $826,646 | $297,704 | $556,125 | | Royalty and operating expenses | $1,184,369 | $1,078,480 | $1,940,721 | $1,530,051 | | Contribution | $4,981,434 | $2,154,844 | $3,136,980 | $1,930,368 | [Liquidity and Capital Resources](index=36&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) This section discusses the company's sources of liquidity, working capital, and capital expenditure plans - Primary liquidity sources are cash equivalents, cash flows from operations, and a revolving line of credit. Management believes these sources are adequate for future growth, business development, and capital expenditures[142](index=142&type=chunk) Liquidity and Working Capital | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :-------------- | :---------------- | | Cash and cash equivalents | $16,087,281 | $17,964,184 | | Working capital | $7,233,189 | $4,830,429 | | Current ratio | 1.3 | 1.2 | | Revolving line of credit availability | $14,759,267 | $4,723,830 | - Net cash provided by operating activities was **$4.7 million** for the six months ended June 30, 2025, a significant improvement from a net cash used of **$3.0 million** in the prior year[143](index=143&type=chunk)[144](index=144&type=chunk) - Cash used in financing activities totaled **$5.7 million**, primarily due to **$10.0 million** in line of credit payments and **$0.7 million** for contingent consideration, partially offset by **$5.3 million** from ATM offering proceeds[146](index=146&type=chunk) [Off-Balance Sheet Arrangements](index=37&type=section&id=OFF-BALANCE%20SHEET%20ARRANGEMENTS) This section confirms the absence of any off-balance sheet arrangements during the reported periods - The company did not engage in any off-balance sheet arrangements during the six months ended June 30, 2025 and 2024[149](index=149&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section assesses the company's exposure to market risks, including interest rate and foreign currency exchange risks - The company is exposed to interest rate risk on cash in money market accounts and its revolving credit facility but does not use derivative financial instruments to manage this exposure[150](index=150&type=chunk) - The interest rate on the revolving credit facility was **7.125%** at June 30, 2025, with **$5.2 million** outstanding. The company believes its interest rate risk is not material[152](index=152&type=chunk) - Foreign currency exchange risk is considered minimal, with immaterial gains and losses for the six months ended June 30, 2025 and 2024[153](index=153&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) This section reports on the effectiveness of the company's disclosure controls and internal control over financial reporting - The company's disclosure controls and procedures were evaluated as effective as of June 30, 2025[154](index=154&type=chunk) - No material changes to internal control over financial reporting occurred during the three months ended June 30, 2025[155](index=155&type=chunk) [PART II – OTHER INFORMATION](index=38&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This section provides additional information not covered in the financial statements, including legal, risk, and equity matters [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to disclosures regarding legal proceedings, indicating no material adverse effects are anticipated - Information on legal proceedings is incorporated by reference from Note 9 of the Financial Statements[157](index=157&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) This section directs investors to the company's Annual Report for a comprehensive discussion of risk factors - Risk factors are incorporated by reference from the company's Annual Report on Form 10-K for the year ended December 31, 2024[158](index=158&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=38&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the company's share repurchase program and any unregistered sales of equity securities - The company has a **$10 million** share repurchase program, with approximately **$2.2 million** remaining available[159](index=159&type=chunk) Share Repurchase Activity (Three Months Ended June 30, 2025) | Period | Total Number of Shares Purchased | Average Price Paid per Share | | :----- | :------------------------------- | :--------------------------- | | April | — | $— | | May | — | — | | June | 1,800 | $5.26 | | **Total** | **1,800** | | [Item 5. Other Information](index=38&type=section&id=Item%205.%20Other%20Information) This section confirms no Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted or modified by insiders - No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted, modified, or terminated by directors or officers during the three months ended June 30, 2025[161](index=161&type=chunk) [Item 6. Exhibits](index=39&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including certifications and XBRL documents - Exhibits include CEO and CFO certifications (31.1, 31.2, 32.1) and INLINE XBRL documents (101.INS, 101.SCH, 101.CAL, 101.DEF, 101.LAB, 101.PRE, 104)[162](index=162&type=chunk) [SIGNATURES](index=40&type=section&id=SIGNATURES) This section contains the official signatures certifying the accuracy and completeness of the report - The report was signed on August 8, 2025, by John Hamm, Chief Financial Officer and Duly Authorized Officer of Cumberland Pharmaceuticals Inc[167](index=167&type=chunk)

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]