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]

Company Update - Cumberland Pharmaceuticals Inc. will release its third quarter 2024 financial results and provide a company update on November 7, 2024, after market close [1] - A conference call is scheduled for November 7 at 4:30 p.m. Eastern Time to discuss the results, with registration available online [1][2] Product Portfolio - Cumberland Pharmaceuticals focuses on developing, acquiring, and commercializing unique products for hospital acute care, gastroenterology, and oncology markets [3] - The company's FDA-approved products include Acetadote®, Caldolor®, Kristalose®, Sancuso®, Vaprisol®, and Vibativ®, which address various medical conditions such as acetaminophen poisoning, pain and fever, constipation, chemotherapy-induced nausea, hyponatremia, and serious bacterial infections [3] Clinical Programs - The company is conducting Phase II clinical programs for its ifetroban product candidate, targeting conditions such as Systemic Sclerosis, cardiomyopathy associated with Duchenne Muscular Dystrophy, and Idiopathic Pulmonary Fibrosis [4]

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 ...

[Executive Summary & Q2 2024 Highlights](index=1&type=section&id=1.%20Executive%20Summary%20%26%20Q2%202024%20Highlights) [Q2 2024 Performance Overview](index=1&type=section&id=1.1%20Q2%202024%20Performance%20Overview) Cumberland Pharmaceuticals demonstrated significantly improved financial results and strong overall corporate performance in Q2 2024 Q2 2024 Key Financial Highlights | Metric | Amount (in millions USD) | | :----------------- | :-------------- | | Net Revenue (Q2 2024) | 9.9 | | QoQ Growth | 16% | | Adjusted Earnings (Q2 2024) | 0.2 | | Improvement from Prior Quarter | 0.8 | | Total Assets | 78.5 | | Total Liabilities | 52.5 | | Shareholders' Equity | 26.3 | - CEO A.J. Kazimi expressed strong optimism for the company's future, anticipating **significant revenue growth** and **positive operating cash flow** for 2024[2](index=2&type=chunk) [Recent Business Developments](index=1&type=section&id=2.%20Recent%20Business%20Developments) [Kristalose® Updates](index=1&type=section&id=2.1%20Kristalose%C2%AE%20Updates) Kristalose® gained Medicaid reimbursement in Wisconsin and was recommended as a first-line treatment for opioid-induced constipation by the AGA - Kristalose® has been added to the **Wisconsin Medicaid formulary**, following previous coverage in New York and Texas[2](index=2&type=chunk) - The American Gastroenterological Association (AGA) guidelines list Kristalose® as a **first-line treatment option** for opioid-induced constipation[3](index=3&type=chunk) [Vibativ® Anthrax Study](index=2&type=section&id=2.2%20Vibativ%C2%AE%20Anthrax%20Study) A new study supports Vibativ® (telavancin) as an effective novel treatment for anthrax infections, showing potent bactericidal activity and improved survival rates - Telavancin effectively **killed all tested anthrax strains** in laboratory settings[4](index=4&type=chunk) - In preclinical studies, **all animals treated with telavancin survived**, and it was superior to levofloxacin in clearing anthrax from the blood and organs[4](index=4&type=chunk)[5](index=5&type=chunk) - Researchers believe telavancin could be an effective new treatment for anthrax, especially as resistance to existing antibiotics grows[5](index=5&type=chunk) [Product Pipeline: Ifetroban](index=2&type=section&id=2.3%20Product%20Pipeline%3A%20Ifetroban) Cumberland is advancing the clinical development of its ifetroban candidate, with three ongoing Phase II programs and pending FDA orphan drug designations [Clinical Study Progress](index=2&type=section&id=2.3.1%20Clinical%20Study%20Progress) Ifetroban has demonstrated a strong safety and tolerability profile in nearly 1,400 subjects, with three Phase II trials currently underway - Ifetroban has been administered to nearly **1,400 subjects** and proven to be safe and well-tolerated[6](index=6&type=chunk) - Three Phase II clinical programs are ongoing for indications including: 1) Systemic Sclerosis, 2) Duchenne Muscular Dystrophy-associated cardiomyopathy, and 3) Idiopathic Pulmonary Fibrosis (the newest program, now enrolling)[6](index=6&type=chunk) [FDA Designations](index=2&type=section&id=2.3.2%20FDA%20Designations) The company has applied for FDA Orphan Drug and Rare Pediatric Disease designations for its Duchenne Muscular Dystrophy candidate - An **Orphan Drug Designation** application has been submitted for the Duchenne Muscular Dystrophy product candidate, which can provide post-approval market exclusivity[7](index=7&type=chunk) - A **Rare Pediatric Disease Designation** application has been submitted, which could result in a Priority Review Voucher upon FDA approval[7](index=7&type=chunk) - Feedback from the FDA on both applications is expected this year[7](index=7&type=chunk) [Future Development Path](index=3&type=section&id=2.3.3%20Future%20Development%20Path) The company plans to complete ongoing studies, analyze data, and determine the optimal registration path for ifetroban - The plan is to complete company-sponsored studies, analyze final data, announce top-line results, and determine the best registration development path for ifetroban[8](index=8&type=chunk) - The company believes ifetroban has the potential to benefit many patients with orphan diseases that have unmet medical needs[8](index=8&type=chunk) [Sancuso® Manufacturing & Supply](index=3&type=section&id=2.4%20Sancuso%C2%AE%20Manufacturing%20%26%20Supply) Cumberland successfully transitioned Sancuso® manufacturing and supply following its 2023 acquisition, with the first branded products now shipping - The transition of Sancuso® from Kyowa Kirin to Cumberland, including the NDA transfer, was **successfully completed in 2023**[9](index=9&type=chunk) - A new Sancuso® manufacturing facility has received **FDA approval**, with the first Cumberland-branded products shipping this summer[9](index=9&type=chunk) [Federal NOPAIN Act & Caldolor®](index=3&type=section&id=2.5%20Federal%20NOPAIN%20Act%20%26%20Caldolor%C2%AE) Cumberland anticipates its non-opioid analgesic Caldolor® will receive separate Medicare reimbursement under the NOPAIN Act starting in 2025 - Cumberland expects Caldolor® to receive **special Medicare reimbursement** under the NOPAIN Act[10](index=10&type=chunk) - The NOPAIN Act requires Medicare to provide **separate reimbursement** for non-opioid pain management products used in hospital outpatient departments or ambulatory surgical centers from January 1, 2025, to January 1, 2028[10](index=10&type=chunk)[11](index=11&type=chunk) - Cumberland submitted clinical information to CMS in September 2023 to support separate reimbursement for Caldolor® and plans to resubmit in September 2024, awaiting the 2025 Medicare OPPS final rule[12](index=12&type=chunk) [Financial Performance](index=4&type=section&id=3.%20Financial%20Performance) [Second Quarter 2024 Financial Highlights](index=4&type=section&id=3.1%20Second%20Quarter%202024%20Financial%20Highlights) The company reported net revenues of $9.9 million in Q2 2024, a 16% sequential increase, with adjusted earnings showing significant improvement Second Quarter and Year-to-Date 2024 Financial Data | Metric | Q2 2024 | YTD 2024 | | :----------------- | :-------------- | :--------------- | | Net Revenue | $9.9 Million | $18.3 Million | | Operating Expenses | $10.9 Million | $21.2 Million | | Net Loss | $1.1 Million | $3.0 Million | | Net Loss per Share | $0.08 | $0.21 | | Adjusted Earnings | $0.2 Million | N/A | | Adjusted Earnings Improvement | +$0.8 Million | N/A | Q2 2024 Net Revenue by Product | Product | Net Revenue (in millions USD) | | :--------- | :---------------- | | Kristalose® | 4.1 | | Vibativ® | 2.5 | | Sancuso® | 2.2 | | Caldolor® | 0.8 | [Condensed Consolidated Balance Sheets](index=7&type=section&id=3.2%20Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2024, total assets stood at $78.5 million, with total liabilities at $52.5 million and shareholders' equity at $26.3 million Condensed Consolidated Balance Sheets (Selected Items) | Metric | June 30, 2024 | Dec 31, 2023 | | :----------------------- | :------------ | :------------- | | **Assets** | | | | Cash and cash equivalents | $17,336,446 | $18,321,624 | | Accounts receivable, net | $11,619,763 | $9,758,176 | | Inventories, net | $4,302,159 | $4,609,362 | | Total assets | $78,519,175 | $81,776,075 | | **Liabilities & Equity** | | | | Accounts payable | $12,508,026 | $14,037,629 | | Revolving line of credit | $16,091,592 | $12,784,144 | | Total liabilities | $52,486,991 | $52,516,206 | | Total stockholders' equity | $26,348,990 | $29,603,441 | [Condensed Consolidated Statements of Operations](index=9&type=section&id=3.3%20Condensed%20Consolidated%20Statements%20of%20Operations) The company recorded a net loss of $1.1 million for Q2 2024, compared to a net income of $0.86 million in the prior-year period Condensed Consolidated Statements of Operations (Selected Items) | Metric | Q2 2024 | Q2 2023 | H1 2024 | H1 2023 | | :------------------------------------- | :------------- | :------------- | :----------- | :----------- | | Net revenues | $9,848,849 | $10,888,877 | $18,346,550 | $20,113,515 | | Selling and marketing expenses | $4,248,401 | $4,672,075 | $8,402,989 | $8,949,393 | | Research and development expenses | $1,059,187 | $1,145,038 | $2,217,440 | $2,644,708 | | Income (loss) from operations | $(1,026,688) | $22,859 | $(2,895,938) | $(1,508,819) | | Net income (loss) | $(1,102,637) | $862,154 | $(3,005,109) | $1,034,440 | | Net income (loss) attributable to common shareholders | $(1,085,612) | $872,200 | $(3,031,875) | $1,064,384 | | Basic earnings (loss) per share | $(0.08) | $0.06 | $(0.21) | $0.07 | | Diluted earnings (loss) per share | $(0.08) | $0.06 | $(0.21) | $0.07 | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=3.4%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $3.0 million for the first six months of 2024, with a period-end cash balance of $17.3 million Condensed Consolidated Statements of Cash Flows (Selected Items) | Metric | H1 2024 | H1 2023 | | :------------------------------------- | :----------- | :----------- | | Net cash from operating activities | $(2,992,307) | $3,817,152 | | Net cash from investing activities | $(104,990) | $(271,261) | | Net cash from financing activities | $2,112,119 | $(5,054,775) | | Net decrease in cash and cash equivalents | $(985,178) | $(1,508,884) | | Cash and cash equivalents at end of period | $17,336,446 | $18,249,086 | [Adjusted Earnings Reconciliation (Non-GAAP)](index=11&type=section&id=3.5%20Adjusted%20Earnings%20Reconciliation%20(Non-GAAP)) Q2 2024 adjusted earnings were $0.18 million, a decrease from $2.3 million in the prior-year period, excluding non-core items Adjusted Earnings (Loss) and Adjusted Diluted EPS (Loss) | Metric | Q2 2024 | Q2 2023 | H1 2024 | H1 2023 | | :------------------------------------- | :------------- | :------------- | :----------- | :----------- | | Net income (loss) attributable to common shareholders | $(1,085,612) | $872,200 | $(3,031,875) | $1,064,384 | | Adjusted earnings (loss) | $184,715 | $2,303,458 | $(455,096) | $3,964,676 | | Adjusted diluted EPS | $0.01 | $0.16 | $(0.03) | $0.27 | [Company Overview](index=5&type=section&id=4.%20Company%20Overview) [About Cumberland Pharmaceuticals](index=5&type=section&id=4.1%20About%20Cumberland%20Pharmaceuticals) Cumberland Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for hospital acute care, gastroenterology, and oncology - The company focuses on providing unique products that improve patient care and commercializes products for the **hospital acute care, gastroenterology, and oncology** markets[16](index=16&type=chunk) - The company has a portfolio of **FDA-approved brands** and is advancing its ifetroban product candidate through Phase II clinical programs[16](index=16&type=chunk)[17](index=17&type=chunk) [FDA-Approved Product Portfolio](index=5&type=section&id=4.2%20FDA-Approved%20Product%20Portfolio) The company's portfolio consists of six FDA-approved branded products targeting specific medical needs in various therapeutic areas [Acetadote® (acetylcysteine) Injection](index=5&type=section&id=4.2.1%20Acetadote%C2%AE%20(acetylcysteine)%20Injection) Acetadote® is an intravenous drug used to prevent or reduce liver injury resulting from acetaminophen poisoning - **Indication**: To prevent or lessen liver damage resulting from acetaminophen poisoning[18](index=18&type=chunk) [Caldolor® (ibuprofen) Injection](index=5&type=section&id=4.2.2%20Caldolor%C2%AE%20(ibuprofen)%20Injection) Caldolor® is the first FDA-approved intravenous ibuprofen for pain management and fever reduction in adult and pediatric patients - **Indications**: Management of mild to moderate pain, an adjunct to opioid analgesics for moderate to severe pain, and fever reduction[20](index=20&type=chunk) - **Feature**: The first FDA-approved intravenous therapy for fever reduction[20](index=20&type=chunk) [Kristalose® (lactulose) Oral Solution](index=6&type=section&id=4.2.3%20Kristalose%C2%AE%20(lactulose)%20Oral%20Solution) Kristalose® is a unique, patented crystalline form of lactulose for treating acute and chronic constipation - **Indication**: Treatment of acute and chronic constipation[21](index=21&type=chunk) - **Feature**: A unique, patented crystalline form of lactulose with no limitations on duration of therapy or patient age[21](index=21&type=chunk) [Sancuso® (granisetron) Transdermal System](index=6&type=section&id=4.2.4%20Sancuso%C2%AE%20(granisetron)%20Transdermal%20System) Sancuso® is the only FDA-approved skin patch for preventing chemotherapy-induced nausea and vomiting (CINV) - **Indication**: Prevention of chemotherapy-induced nausea and vomiting (CINV)[22](index=22&type=chunk) - **Feature**: The only FDA-approved skin patch for CINV prevention, providing up to five days of protection[22](index=22&type=chunk) [Vaprisol® (conivaptan) Injection](index=6&type=section&id=4.2.5%20Vaprisol%C2%AE%20(conivaptan)%20Injection) Vaprisol® is an intravenous vasopressin receptor antagonist for treating hyponatremia in critical care settings - **Indication**: Treatment of hyponatremia in critical care settings[24](index=24&type=chunk) - **Mechanism**: A vasopressin receptor antagonist that raises serum sodium levels and promotes free water excretion[24](index=24&type=chunk) [Vibativ® (telavancin) Injection](index=6&type=section&id=4.2.6%20Vibativ%C2%AE%20(telavancin)%20Injection) Vibativ® is a patented, injectable anti-infective for treating certain serious bacterial infections, including those caused by resistant Gram-positive pathogens - **Indications**: Treatment of serious bacterial infections, including hospital-acquired and ventilator-associated bacterial pneumonia, and complicated skin and skin structure infections[25](index=25&type=chunk) - **Feature**: Specifically designed to kill resistant Gram-positive bacterial pathogens[25](index=25&type=chunk) [About Cumberland Emerging Technologies](index=6&type=section&id=4.3%20About%20Cumberland%20Emerging%20Technologies) CET is a joint initiative to commercialize biomedical technologies from regional research centers by providing expertise and infrastructure - CET is a joint initiative of **Cumberland Pharmaceuticals, Vanderbilt University, LaunchTN, and WinHealth**[26](index=26&type=chunk) - Its mission is to advance biomedical technologies and products from research centers to the market[26](index=26&type=chunk) - It provides expertise in intellectual property, regulatory affairs, manufacturing, and marketing, as well as lab space for early-stage life science companies[26](index=26&type=chunk) [Additional Information](index=4&type=section&id=5.%20Additional%20Information) [Earnings Report Call Details](index=4&type=section&id=5.1%20Earnings%20Report%20Call%20Details) The company will host a conference call on August 6, 2024, to provide a corporate update and discuss financial results - The conference call will be held on **August 6, 2024, at 4:30 p.m. ET**[15](index=15&type=chunk) - The call is intended to provide a company update and discuss financial performance[15](index=15&type=chunk) - Participants must register, and a replay of the call will be available for one year[15](index=15&type=chunk) [Forward-Looking Statements](index=7&type=section&id=5.2%20Forward-Looking%20Statements) This release contains forward-looking statements subject to various risks and uncertainties, and the company undertakes no obligation to update them - Forward-looking statements reflect the company's current views and expectations about future events but are **not guarantees** that these events will occur[27](index=27&type=chunk) - Risk factors include macroeconomic conditions, competition, manufacturing capabilities, regulatory compliance, natural disasters, and public health epidemics[27](index=27&type=chunk) - Readers are cautioned not to place undue reliance on these statements, and the company has **no obligation to publicly revise them** to reflect subsequent events[27](index=27&type=chunk) [Non-GAAP Financial Measures Explanation](index=12&type=section&id=5.3%20Non-GAAP%20Financial%20Measures%20Explanation) The company provides non-GAAP financial measures as a supplement to GAAP results to help assess core operational performance - Non-GAAP financial measures are considered a **supplement to GAAP financial information** for evaluating the company's operational performance[35](index=35&type=chunk)[36](index=36&type=chunk) - **Adjusted earnings (loss)** is defined as net income (loss) adjusted for income taxes, depreciation, amortization, stock-based compensation, and interest[37](index=37&type=chunk) - **Adjusted diluted EPS (loss)** is defined as adjusted earnings (loss) divided by the diluted weighted-average common shares outstanding[37](index=37&type=chunk) [Investor & Media Contacts](index=7&type=section&id=5.4%20Investor%20%26%20Media%20Contacts) This section provides contact information for Cumberland Pharmaceuticals' investor relations and media representatives - **Investor Contact**: Shayla Simpson, (615) 255-0068[29](index=29&type=chunk) - **Media Contact**: Molly Aggas (Dalton Agency), (704) 641-6641[29](index=29&type=chunk)

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 ...

Core Viewpoint - Cumberland Pharmaceuticals Inc. is set to release its second quarter 2024 financial results and provide a company update on August 6, 2024, after market close [4]. Company Overview - Cumberland Pharmaceuticals is a specialty pharmaceutical company focused on developing, acquiring, and commercializing unique products that enhance patient care, particularly in the hospital acute care, gastroenterology, and oncology market segments [6]. Product Portfolio - The company has a portfolio of FDA-approved brands, including: - Acetadote® (acetylcysteine) injection for acetaminophen poisoning - Caldolor® (ibuprofen) injection for pain and fever - Kristalose® (lactulose) for constipation - Omeclamox®-Pak (omeprazole, clarithromycin, amoxicillin) for H. pylori infection and related duodenal ulcer disease - Sancuso® (granisetron) transdermal system for nausea and vomiting prevention in chemotherapy patients - Vaprisol® (conivaptan) injection for raising serum sodium levels in hospitalized patients - Vibativ® (telavancin) injection for serious bacterial infections [7]. Clinical Programs - Cumberland is conducting Phase II clinical programs for its ifetroban product candidate, targeting patients with cardiomyopathy associated with Duchenne Muscular Dystrophy and Systemic Sclerosis. The company has also received FDA clearance to proceed directly to a Phase II study for patients with Idiopathic Pulmonary Fibrosis [3].

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Financial Data and Key Metrics Changes - For Q1 2024, the company recorded net revenues of $8.5 million, with a net loss of $1.9 million, and an adjusted loss of $0.6 million when non-cash expenses are added back [25][59] - Total operating expenses for the first quarter were $10.4 million, and the company continues to hold over $52 million in tax net operating loss carryforwards [59][61] Business Line Data and Key Metrics Changes - Net revenue by product included $3.2 million for Kristalose, $1.8 million for Sancuso, $1.6 million for Vibativ, and $1.5 million for Caldolor [25] - Kristalose remains the largest selling product, benefiting from favorable Medicaid coverage in several states, including New York [43] Market Data and Key Metrics Changes - The company noted that Q1 sales were typically lighter due to patients working through new insurance deductibles, but overall demand for brands remained steady [10][37] - The NOPAIN Act is expected to provide favorable reimbursement for non-opioid products like Caldolor, which could significantly impact future growth [19][46] Company Strategy and Development Direction - The company is focused on expanding its portfolio of FDA-approved brands and developing innovative products through both internal development and acquisitions [11] - A strategy to increase awareness of products within the medical community is being implemented, with marketing initiatives supporting the use of Caldolor and Vibativ [38][39] Management Comments on Operating Environment and Future Outlook - Management expressed optimism about achieving double-digit revenue growth and positive cash flow from operations in 2024, despite external challenges [37] - The company is encouraged by ongoing positive developments and the impact of sales and marketing initiatives on brand performance [56] Other Important Information - The company has initiated clinical programs for ifetroban, targeting unmet medical needs in patients with pulmonary fibrosis and Duchenne Muscular Dystrophy [22][23] - Cumberland continues to repurchase shares as part of its corporate share repurchase program, buying a total of 126,000 shares during the first quarter [27] Q&A Session Summary Question: What is the outlook for Caldolor under the NOPAIN Act? - Management expects the NOPAIN Act to significantly impact Medicare reimbursement for Caldolor, with implementation scheduled for early 2025 [19][46] Question: How is the company addressing the challenges in the current market? - Management noted that the overall demand for brands was steady, and they believe it is best to evaluate performance on an annual basis [10][37] Question: What are the growth opportunities for Kristalose? - The company is optimistic about expanding Kristalose's use in states with favorable Medicaid coverage and has launched initiatives to increase market presence [29][43]