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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Start Time: 15:30 January 1, 0000 3:59 PM ET Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) Q1 2024 Earnings Conference Call May 07, 2024, 15:30 PM ET Company Participants A.J. Kazimi - CEO Todd Anthony - VP, Organizational Development John Hamm - CFO Molly Aggas - Account Supervisor, Dalton Agency Conference Call Participants Operator Good afternoon, and welcome to Cumberland Pharmaceuticals First Quarter 2024 Financial Report and Company Update. This call is being recorded at Cumberland's request and will ...

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 March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Cumberland Pharmaceuticals Inc. (Exact Name of Registrant as Specified In Its Charter) Tennessee 62-1765329 (State or Other Jurisdiction of Incorporation o ...

Cumberland Pharmaceuticals Reports First Quarter 2024 ® About Kristalose (lactulose) Oral Solution ® About Sancuso (granisetron) Transdermal System Sancuso is the only skin patch approved by the U.S. Food and Drug Administration for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy. When applied 24 to 48 hours before receiving chemotherapy, the SANCUSO patch slowly and continuously releases the medicine contained in the a ...

NASHVILLE, Tenn., April 30, 2024 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, announced today that it will release its first quarter 2024 financial results and provide a company update after the market closes on Tuesday, May 7, 2024.A conference call will be held on May 7 at 4:30 p.m. Eastern Time to discuss the results. To participate in the call, please register at https://register.vevent.com/register/BIbb2d35bc9570474dabf8b2e3d2e4ca72.Once registered ...

Growing data shows intravenous ibuprofen is safe and effective for the treatment of pain and fever in adults, children and infants NASHVILLE, Tenn., April 2, 2024 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, today announced the release of a Special Report evaluating the growing amount of current data supporting the use of its Caldolor® product (intravenous ibuprofen, or IVIB) as a standard of care for the treatment of pain and fever in adults, children ...