Lactulose

精彩内容今年以来，葫芦娃药业产品研发进展不断：5个品种获批生产并视同过评，2个品种通过一致性评价，3个品种有望于6月底前获批生产或过评，多个报产品种步入或即将步入发补阶段；申报方面，3个品种以新注册分类报产，中药新药提交IND，3个仿制药、1款2类改良型新药有望于6月底前申报上市。此外，还有多个研发项目正在加速推进中。拿下5个重磅品种！大批新品上市在即葫芦娃药业聚焦儿童药领域，近年来积极布局具有潜力及特色的品种，新品获批迎来爆发期。2024年，葫芦娃药业有13个品种获批生产并视同过评，2个品种顺利通过一致性评价；2025年至今，公司已有5个品种获批生产并视同过评，2个品种顺利通过一致性评价。今年以来葫芦娃药业获批上市/过评的品种截至目前，葫芦娃药业有30个品种过评或视同过评，涵盖7个治疗大类，集中在全身用抗感染药物（9个品种）、呼吸系统用药（7个品种）、消化系统及代谢药（5个品种）等领域。在葫芦娃药业已报产或提交一致性评价补充申请在审的品种中，头孢丙烯干混悬剂、依巴斯汀口服溶液有望于今年6月底前获批生产并视同过评，均为口服液体剂。该剂型具有服用便捷、吸收快、口感好等优势，适合儿童、老年人等特殊人群使用，目前葫芦娃药业已有7款口服液体剂（化学药）获批。米内网数据显示，2024年中国三大终端六大市场（统计范围详见本文末）口服液体剂（化学药）销售额超过410亿元。有望于6月底前获批上市/过评的品种此外，今年以来，葫芦娃药业有5个以新注册分类报产、2个提交一致性评价补充申请的品种已步入发补阶段，距离正式获批更近了一步。其中，磷酸奥司他韦干混悬剂、头孢丙烯干混悬剂均为口服液体剂，吸入用复方异丙托溴铵溶液有望成为公司第四款获批的吸入剂。已进入发补阶段的品种6个以新注册分类报产的品种有望于今年6月底前进入发补阶段，包括氨溴特罗口服溶液、乳果糖口服溶液、盐酸氨溴索滴剂、蒙脱石混悬液、硫酸镁钠钾口服用浓溶液5款口服液体剂，以及盐酸奥普力农注射液1款注射剂。其中，乳果糖口服溶液2024年在中国三大终端六大市场的销售额超过22亿元。有望在6月底前进入发补阶段的品种中药新药、改良型新药、高端制剂......多个研发项目火速推进葫芦娃药业坚持仿创结合，积极开发吸入剂、口溶膜、缓释控释制剂等技术壁垒高、市场前景广的新剂型产品。今年以来，葫芦娃药业有3个品种以新注册分类报产，其中枸橼酸西地那非口溶膜有望成为公司首款口溶膜制剂，该产品在国内暂无企业拥有生产批文；美阿沙坦钾片是一款具有市场潜力的高血压用药，2024年在中国三大终端六大市场的销售额增速约达194%，目前获批上市的国内企业仅有3家。今年以来葫芦娃药业申报上市/临床的品种此外，艾地骨化醇软胶囊、硫酸氨基葡萄糖胶囊、复方聚乙二醇电解质散（儿童型）3个仿制药以及2.2类改良型新药LPC-011口溶膜有望于今年6月底前申报上市。其中，艾地骨化醇软胶囊2024年在中国三大终端六大市场的销售额增速超过400%；LPC-011口溶膜为布瑞哌唑改良剂型，目前国内已获批上市的布瑞哌唑制剂仅有大冢制药的布瑞哌唑片。有望于6月底前申报上市的品种此外，葫芦娃药业部分在研项目也在加速推进中：盐酸溴己新雾化吸入溶液III期临床试验预计第三季度完成总结报告，目前国内暂无企业拥有该产品生产批文；布瑞哌唑口溶膜（LPC-011）预计将于第二季度完成临床试验总结报告并申报NDA；头孢泊肟酯干混悬剂、瑞舒伐他汀依折麦布片等已于第一季度完成BE试验。资料来源：米内网数据库、公司资料等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至5月6日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

NASHVILLE, Tenn. , May 6, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, announced today that its product portfolio of FDA-approved brands delivered combined net revenues of $11.7 million during the first quarter of 2025, a 38% increase over the prior year period. As a result the Company generated a net profit of $1.3 million for the quarter, adjusted earnings of $2.4 million , and cash flow from operations of $3.9 million . Cumberland ended the quarter with approximately $70 million in total assets, $41.6 million in liabilities and $28.7 million of shareholders' equity. "We are entering an exciting time for our company, as we continue to build momentum and capitalize on a range of promising opportunities," said Cumberland Pharmaceuticals CEO A.J. Kazimi . "Our optimism is driven by strong performance from our approved brands, the expansion of international partnerships, meaningful progress across our clinical development programs and the potential for strategic acquisitions." RECENT COMPANY DEVELOPMENTS INCLUDE: Top-Line DMD Study Results In February 2025 , Cumberland announced positive top-line results from the Phase II study evaluating its ifetroban product candidate in patients with Duchenne muscular dystrophy (DMD). This marks a breakthrough for these patients, as it's the first successful Phase II study specifically targeting the cardiac complications of their condition. These study results were selected for a late-breaking presentation in March at the Muscular Dystrophy Association 's Clinical & Scientific Conference . That platform allowed Cumberland to share the promising results with the global DMD community, including leading researchers, clinicians and patient advocates who are working tirelessly to improve outcomes for those affected by this devastating disease. Next steps for Cumberland's DMD program include further data analysis and completion of a full study report in preparation for an end-of- Phase-II meeting with the FDA to determine the requirements for the product's approval. Vibativ® Approval in China Cumberland's potent antibiotic, Vibativ®, received approval from the regulatory authorities in China . This provides Cumberland access to the world's second-largest pharmaceutical market. The company expects the product to launch by the end of the year. FINANCIAL RESULTS: Net Revenue: For first quarter of 2025, net revenues were $11.7 million and included $3.5 million for Kristalose®, $2.3 million for Sancuso®, $1.4 million for Vibativ® and $1.3 million for Caldolor®. Operating Expenses: Total operating expenses for the quarter were $10.4 million . Net Income: The net income for the first quarter of 2025 was approximately $1.3 million . Adjusted Earnings: Adjusted earnings for the quarter were $2.4 million , or $0.16 per share. Balance Sheet: At March 31, 2025 , Cumberland had approximately $70 million in total assets, including $15.1 million in cash and cash equivalents. Liabilities totaled $41.6 million , including $5.2 million on the company's credit facility. Total shareholders' equity was $28.7 million on March 31, 2025 . EARNINGS REPORT CALL: A conference call will be held today, May 06, 2025 , at 4:30 p.m. Eastern Time to provide a company update and discuss the financial results. The link to register is: https://register-conf.media-server.com/register/BIea2bc7f82dd24caea135dbe5460d9b6f. Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference. A replay of the call will be available for one year and can be accessed via Cumberland's website or by visiting: https://edge.media-server.com/mmc/p/wost2na9/. ABOUT CUMBERLAND PHARMACEUTICALS : Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes: Acetadote® (acetylcysteine) injection, for the treatment of acetaminophen poisoning; Caldolor® (ibuprofen) injection, for the treatment of pain and fever; Kristalose® (lactulose) oral, a prescription laxative, for the treatment of constipation; Sancuso® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; Vaprisol® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and Vibativ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections. The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with Duchenne Muscular Dystrophy, Systemic Sclerosis and Pulmonary Fibrosis. For more information on Cumberland's approved products, including full prescribing information, please visit the links to the individual product websites, which can be found on the company's website at www.cumberlandpharma.com. About Acetadote® (acetylcysteine) Injection Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter medications. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. For full prescribing and safety information, visit www.acetadote.com. About Caldolor® (ibuprofen) Injection Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs) as well as patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. For full prescribing and safety information, including boxed warning, visit www.caldolor.com. About Kristalose® (lactulose) Oral Solution Kristalose is indicated for the treatment of acute and chronic constipation. It is a unique, proprietary, crystalline form of lactulose, with no restrictions on length of therapy or patient age. Kristalose is contraindicated in patients who require a low-galactose diet. Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically. For full prescribing and safety information, visit www.kristalose.com. About Sancuso® (granisetron) Transdermal System Sancuso is the only skin patch approved by the FDA 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 adhesive through clean and intact skin areas into the patient's bloodstream. It can prevent CINV for chemotherapy regimens of up to five consecutive days. For full prescribing and safety information, visit www.sancuso.com. About Vaprisol® (conivaptan hydrochloride) Injection Vaprisol is an intravenous treatment for hyponatremia used in the critical care setting. Hyponatremia is an electrolyte disturbance in which sodium ion concentration in blood plasma is lower than normal. This can be associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure and pneumonia. The product is a vasopressin receptor antagonist that raises serum sodium levels and promotes free water secretion. Vaprisol is contraindicated in patients with hypovolemic hyponatremia. The coadministration of Vaprisol with potent CYP3A inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir and indinavir, is contraindicated. For full prescribing and safety information, including boxed warning, visit www.vaprisol.com. About Vibativ® (telavancin) for Injection Vibativ is a patented, FDA-approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin structure infections. It addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant. Intravenous unfractionated heparin sodium is contraindicated with Vibativ administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after Vibativ administration. Vibativ is contraindicated in patients with a known hypersensitivity to telavancin. For more information, please visit www.vibativ.com. ABOUT CUMBERLAND EMERGING TECHNOLOGIES: Cumberland Emerging Technologies, Inc. (www.cet-fund.com) is a joint initiative between Cumberland Pharmaceuticals Inc. , Vanderbilt University , LaunchTN and WinHealth. The mission of CET is to advance biomedical technologies and products conceived at Vanderbilt University and other regional research centers towards the marketplace. CET helps manage the development and commercialization process for select projects, and provides expertise on intellectual property, regulatory, manufacturing and marketing issues that are critical to successful new biomedical products. CET's Life Sciences Center provides laboratory space, equipment and infrastructure for CET's activities and other early-stage life sciences ventures. FORWARD LOOKING STATEMENTS: This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the Company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include macroeconomic conditions, including rising interest rates and inflation, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the Company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission (" SEC "), as well as the Company's other filings with the SEC from time to time. There can be no assurance that results anticipated by the company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof. CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIESCondensed Consolidated Balance Sheets(Unaudited) March 31, 2025 December 31, 2024 ASSETS Current assets: Cash and cash equivalents $ 15,108,413 $ 17,964,184 Accounts receivable, net 10,487,925 11,701,466 Inventories, net 4,098,859 3,999,995 Prepaid and other current assets 2,181,954 2,786,513 Total current assets 31,877,151 36,452,158 Non-current inventories 9,939,236 11,005,499 Property and equipment, net 298,740 277,365 Intangible assets, net 16,986,962 17,973,449 Goodwill 914,000 914,000 Operating lease right-of-use assets 7,177,490 6,176,923 Other assets 2,742,299 2,784,016 Total assets $ 69,935,878 $ 75,583,410 LIABILITIES AND EQUITY Current liabilities: Accounts payable $ 13,927,623 $ 13,914,266 Operating lease current liabilities 371,094 356,508 Current portion of revolving line of credit — 5,100,000 Other current liabilities 11,220,902 12,250,955 Total current liabilities 25,519,619 31,621,729 Revolving line of credit - long term 5,240,733 10,176,170 Operating lease non-current liabilities 4,829,054 4,939,739 Other long-term liabilities 6,005,853 6,299,795 Total liabilities 41,595,259 53,037,433 Equity: Shareholders' equity: Common stock—no par value; 100,000,000 shares authorized; 14,961,137and 13,952,624 shares issued and outstanding as of March 31, 2025 and December 31, 2024 , respectively 51,367,883 46,821,425 Accumulated deficit (22,710,863) (23,967,931) Total shareholders' equity 28,657,020 22,853,494 Noncontrolling interests (316,401) (307,517) Total equity 28,340,619 22,545,977 Total liabilities and equity $ 69,935,878 $ 75,583,410 CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIESCondensed Consolidated Statements of Operations(Unaudited) Three months ended March 31 , 2025 2024 Net revenues $ 11,713,055 $ 8,497,701 Costs and expenses: Cost of products sold 1,425,714 1,575,542 Selling and marketing 4,231,980 4,154,588 Research and development 1,295,076 1,158,253 General and administrative 2,463,008 2,367,907 Amortization 1,005,330 1,110,661 Total costs and expenses 10,421,108 10,366,951 Operating income (loss) 1,291,947 (1,869,250) Interest income 125,709 96,746 Interest expense (163,802) (118,526) Income (loss) before income taxes 1,253,854 (1,891,030) Income tax expense (5,670) (11,442) Net income (loss) 1,248,184 (1,902,472) Net loss (income) at subsidiary attributable to noncontrolling interests 8,884 (43,791) Net income (loss) attributable to common shareholders $ 1,257,068 $ (1,946,263) Earnings (loss) per share attributable to common shareholders - basic $ 0.08 $ (0.14) - diluted $ 0.08 $ (0.14) Weighted-average shares outstanding - basic 14,942,522 14,098,022 - diluted 15,259,824 14,098,022 CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIESCondensed Consolidated Statements of Cash Flows(Unaudited) Three months ended March 31 , 2025 2024 Cash flows from operating activities: Net income (loss) $ 1,248,184 $ (1,902,472) Adjustments to reconcile net loss to net cash provided by operating activities: Depreciation and amortization expense 1,031,584 1,150,685 Amortization of operating lease right-of-use assets 285,184 285,184 Share-based compensation 74,212 78,754 Increase (decrease) in non-cash contingent consideration 44,976 (230,430) Decrease (increase) in cash surrender value of life insurance policies overpremiums paid 81,182 (129,217) Noncash interest expense 5,362 3,810 Net changes in assets and liabilities affecting operating activities: Accounts receivable 1,213,541 (1,066,410) Inventories, net 967,399 170,469 Other current assets and other assets 60,371 205,619 Operating lease liabilities (219,493) (213,825) Accounts payable and other current liabilities (600,043) (645,542) Other long-term liabilities (293,942) 156,728 Net cash provided by (used in) operating activities 3,898,517 (2,136,647) Cash flows from investing activities: Additions to property and equipment (47,630) (41,621) Net investment in manufacturing facility (1,162,357) — Additions to intangible assets (18,199) (16,565) Net cash used in investing activities (1,228,186) (58,186) Cash flows from financing activities: Proceeds from ATM offering, net 5,266,334 — Borrowings on line of credit — 11,000,000 Payments on line of credit (10,035,437) (7,700,000) Cash settlement of contingent consideration (511,131) (630,701) Payments made in connection with repurchase of common shares (245,868) (247,605) Net cash provided by (used in) financing activities (5,526,102) 2,421,694 Net increase (decrease) in cash and cash equivalents (2,855,771) 226,861 Cash and cash equivalents at beginning of period $ 17,964,184 $ 18,321,624 Cash and cash equivalents at end of period $ 15,108,413 $ 18,548,485 CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIESReconciliation of Net Income (loss) Attributable to Common Shareholders to Adjusted Earnings (loss) andAdjusted Diluted Earnings (loss) Per Share(Unaudited) Three months ended March 31 , Three months ended March 31 , 2025 2025 2024 2024 Earningsimpact Earnings per share impact Earningsimpact Earnings pershare impact Net income (loss) attributable to commonshareholders $ 1,257,068 $ 0.08 $ (1,946,263) $ (0.14) Less: Net (income) loss at subsidiary attributable tononcontrolling interests 8,884 — (43,791) — Net income (loss) 1,248,184 0.08 (1,902,472) (0.13) Adjustments to net income (loss) Income tax expense 5,670 — 11,442 — Depreciation and amortization 1,031,584 0.07 1,150,685 0.08 Share-based compensation (a) 74,212 — 78,754 0.01 Interest income (125,709) (0.01) (96,746) (0.01) Interest expense 163,802 0.01 118,526 0.01 Adjusted earnings (loss) and adjusted diluted earnings (loss) per share $ 2,397,743 $ 0.16 $ (639,811) $ (0.05) Diluted weighted-average common shares outstanding: 15,259,824 14,098,022 The Company provided the above adjusted supplemental financial performance measures, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. These financial measures should be considered supplemental to, and not as a substitute for, financial information prepared in accordance with Generally Accepted Accounting Principles ("GAAP"). The definition of these supplemental measures may differ from similarly titled measures used by others. Because these supplemental financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety. A reconciliation of the supplemental financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release. Cumberland's management believes these supplemental financial performance measures are important as they are used by management, along with financial measures in accordance with GAAP, to evaluate the Company's operating performance. In addition, Cumberland believes that they will be used by certain investors to measure the Company's operating results. Management believes that presenting these supplemental measures provides useful information about the Company's underlying performance across reporting periods on a consistent basis by excluding items that Cumberland does not believe are indicative of its core business performance or reflect long-term strategic activities. Certain of these items are not settled through cash payments and include: depreciation, amortization, share-based compensation expense and income taxes. Cumberland utilizes its net operating loss carryforwards to pay minimal income taxes. In addition, the use of these financial measures provides greater transparency to investors of supplemental information used by management in its financial and operational decision-making, including the evaluation of the Company's operating performance. The Company defines these supplemental financial measures as follows: Adjusted Earnings (loss): net income (loss) adjusted for the impact of income taxes, depreciation and amortization expense, share-based compensation, interest income and interest expense. (a) Represents the share-based compensation of Cumberland. Adjusted Diluted Earnings (loss) Per Share: Adjusted Earnings (loss) divided by diluted weighted-average common shares outstanding. View original content to download multimedia:https://www.prnewswire.com/news-releases/cumberland-pharmaceuticals-reports-38-revenue-growth-in-q1-2025-302447518.html SOURCE Cumberland Pharmaceuticals Inc. Investor Contact: Shayla Simpson, Cumberland Pharmaceuticals Inc., (615) 255-0068; Media Contact: Molly Aggas, Dalton Agency, (704) 641-6641