US Market News
1月前
CUMBERLAND PHARMACEUTICALS REPORTS Q1 2026 FINANCIAL RESULTS & COMPANY UPDATEMay 5, 2026 5:00 PM
PR Newswire (US) Enters into Strategic Transaction, unlocking $100 million in valueSharpens focus on Orphan Drug candidates to address unmet medical needsNASHVILLE, Tenn., May 5, 2026 /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 $9.1 million during the first quarter of 2026. Cumberland ended the quarter with $71.0 million in total assets, $49.7 million in liabilities and $21.6 million of shareholders' equity."We entered 2026 with strong momentum following an outstanding 2025, which featured double-digit revenue growth, the addition of a new product to our portfolio, new international approvals and breakthrough clinical study results," said A.J. Kazimi, Cumberland Pharmaceuticals CEO. "We have built on that momentum through our recently announced Strategic Transaction, which represents an important next step in our Company's evolution, enabling us to sharpen our focus on developing high-value product candidates, while unlocking significant value for our shareholders."RECENT COMPANY DEVELOPMENTS INCLUDE:Strategic Transaction Cumberland recently announced a Strategic Transaction with Apotex Inc., the largest Canadian-based pharmaceutical company, to integrate the branded U.S. commercial businesses. Under the terms of the agreement, Apotex will acquire Cumberland's portfolio of FDA-approved brands for $100 million in cash consideration, subject to Cumberland shareholders' approval and certain other customary closing conditions.This transaction is designed to unlock value and sharpen Cumberland's focus on advancing its pipeline of differentiated product candidates designed to address unmet medical needs. The integration of Cumberland's products will create more critical mass to support patient care and expand product distribution.Following the closing of the transaction, Cumberland will retain its development programs, as well as its majority ownership in Cumberland Emerging Technologies. This positions Cumberland to operate with the profile of an innovative, development-stage biopharmaceutical organization devoted to new medicines for the future.Development PipelineIn addition to its portfolio of FDA-approved brands involved in the transaction with Apotex, Cumberland is developing ifetroban, a potent thromboxane antagonist, through a series of clinical programs designed to address unmet medical needs with significant market potential.Cumberland has announced breakthrough results in a Phase II clinical study of ifetroban in patients with cardiomyopathy associated with Duchenne muscular dystrophy ("DMD"). This rare, fatal genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles. Discussions with the FDA are underway regarding the study results and remaining requirements for approval.During the first quarter of 2026, the FDA granted Fast Track Designation for Cumberland's ifetroban candidate product for DMD patients.This designation is intended to accelerate the development and review of therapies that address serious conditions with unmet medical needs. Importantly, it allows for more frequent FDA interaction, rolling data submissions and earlier guidance throughout the approval process. The program previously received both Orphan Drug and Rare Pediatric Disease designations from the FDA.In addition, Cumberland has a Phase II clinical program evaluating its ifetroban product candidate in patients with Systemic Sclerosis ("SSc") or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs. Enrollment in the study is completed and the next milestone will be announcing its top-line study results.Cumberland's third development program involves the use of ifetroban in patients with Idiopathic Pulmonary Fibrosis ("IPF"), the most common form of progressive fibrosing interstitial lung disease. Enrollment in the study is well underway at medical centers across the U.S., with interim safety and interim efficacy results pending.FINANCIAL RESULTS:Net Revenue: For first quarter of 2026, the Company's net revenues of $9.1 million, which represented a 5% increase compared to the first quarter of 2025 after removing the $3 million milestone payment last year associated with the approval of Vibativ® in China. Cumberland's branded portfolio revenue included $1.0 million for Kristalose®, $2.9 million for Sancuso®, $2.1 million for Vibativ®, $1.0 million for Caldolor® and $1.9 million for Talicia.®Operating Expenses: Total operating expenses for the quarter were $12.3 million. Net Income (Loss): The net loss for the first quarter of 2026 was approximately $3.3 million. Adjusted Earnings (Loss): Adjusted loss for the quarter was $1.9 million, or $0.13 per share. Balance Sheet: At March 31, 2026, Cumberland had approximately $71.0 million in total assets, including $11.0 million in cash and cash equivalents. Liabilities totaled $49.7 million, including $5.2 million on the company's credit facility. Total shareholders' equity was $21.6 million on March 31, 2026.EARNINGS REPORT CALL:A conference call will be held today, May 5, 2026, 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/BI31a40566a8cb4846873ec8b25642be3a.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/rik67g7q.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;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; andTalicia® (omeprazole, amoxicillin and rifabutin) oral capsule, for the treatment of H. pylori infection.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) InjectionAcetadote, 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) InjectionCaldolor 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 SolutionKristalose 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 SystemSancuso 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) InjectionVaprisol 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 InjectionVibativ 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 Talicia® Talicia® is an FDA approved oral capsule for the treatment of Helicobacter pylori (H. pylori) infection in adults, a bacterial infection of the stomach and leading risk factor for gastric cancer. Talicia is listed as a first line option in the 2024 ACG Guideline for the treatment of H. pylori and features three key advantages: 1) high eradication rates - >90% in confirmed adherent patients, 2) the simplicity of an all-in-one capsule, and 3) low resistance to the two antibiotics - amoxicillin and rifabutin. For more information, please visit www.talicia.com.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," "goal", "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 risks and uncertainties related to the strategic transaction, risks related to our ability to develop our pipeline of new product candidates, macroeconomic conditions, including changes in interest rates, inflation, tariffs, 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, 2026
December 31, 2025ASSETS
Current assets:
Cash and cash equivalents$ 11,007,245
$ 11,444,693Accounts receivable, net14,261,978
16,944,780Inventories, net5,453,836
6,225,518Prepaid and other current assets2,066,198
2,445,276Total current assets32,789,257
37,060,267Non-current inventories9,875,505
9,253,090Property and equipment, net237,375
264,724Intangible assets, net12,793,249
14,027,921Goodwill914,000
914,000Co-commercialization investment3,840,700
3,986,780Operating lease right-of-use assets7,618,720
8,343,832Other assets2,926,214
2,973,378Total assets$ 70,995,020
$ 76,823,992LIABILITIES AND EQUITY
Current liabilities:
Accounts payable$ 16,537,072
$ 18,567,546Operating lease current liabilities485,162
467,774Other investment liabilities4,487,137
5,074,504Other current liabilities12,978,680
12,635,095Total current liabilities34,488,051
36,744,919Revolving line of credit - long term5,240,733
5,240,733Operating lease non-current liabilities4,343,892
4,471,965Other long-term liabilities5,619,332
5,822,153Total liabilities49,692,008
52,279,770Equity:
Shareholders' equity:
Common stock— no par value; 100,000,000 shares authorized; 14,983,107 and 14,956,627 shares issued and outstanding as of March 31, 2026, and December 31, 2025, respectively51,730,222
51,684,381Accumulated deficit(30,093,698)
(26,804,059)Total shareholders' equity21,636,524
24,880,322Noncontrolling interests(333,512)
(336,100)Total equity21,303,012
24,544,222Total liabilities and equity$ 70,995,020
$ 76,823,992 CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIESCondensed Consolidated Statements of Operations(Unaudited)
Three months ended March 31,
2026
2025Net revenues$ 9,131,317
$ 11,713,055Costs and expenses:
Cost of products sold1,933,889
1,425,714Selling and marketing5,064,875
4,231,980Research and development1,458,436
1,295,076General and administrative2,554,475
2,463,008Amortization1,248,934
1,005,330Total costs and expenses12,260,609
10,421,108Operating income (loss)(3,129,292)
1,291,947Interest income78,031
125,709Interest expense(85,839)
(163,802)Income (loss) before income taxes(3,137,100)
1,253,854Income tax expense(3,871)
(5,670)Co-commercialization investment loss(146,080)
—Net income (loss)(3,287,051)
1,248,184Net loss (income) at subsidiary attributable to noncontrolling
interests(2,588)
8,884Net income (loss) attributable to common shareholders$ (3,289,639)
$ 1,257,068Income (loss) per share attributable to common shareholders
- basic$ (0.22)
$ 0.08- diluted$ (0.22)
$ 0.08Weighted-average shares outstanding
- basic14,960,210
14,942,522- diluted14,960,210
15,259,824
CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIESCondensed Consolidated Statements of Cash Flows(Unaudited)
Three months ended March 31,
2026
2025Cash flows from operating activities:
Net (loss) income$ (3,287,051)
$ 1,248,184Adjustments to reconcile net income (loss) to net cash provided by operating
activities:
Depreciation and amortization expense1,276,283
1,031,584Amortization of operating lease right-of-use asset285,184
285,184Co-commercialization investment loss146,080
—Share-based compensation106,842
74,212Increase (decrease) in non-cash contingent consideration(228,965)
44,976Decrease in cash surrender value of life insurance policies over premiums
paid86,949
81,182Noncash interest expense5,173
5,362Net changes in assets and liabilities affecting operating activities:
Accounts receivable2,682,802
1,213,541Inventories, net703,861
967,399Other current assets and other assets384,152
60,371Operating lease liabilities(225,351)
(219,493)Accounts payable and other current liabilities(1,346,113)
(600,043)Other long-term liabilities(202,821)
(293,942)Net cash provided by operating activities387,025
3,898,517Cash flows from investing activities:
Additions to property and equipment—
(47,630)Increase in cash surrender value of life insurance policies(42,018)
—Net (increase) decrease of investment in manufacturing
(1,162,357)Additions to intangible assets(19,155)
(18,199)Net cash provided by (used in) investing activities(61,173)
(1,228,186)Cash flows from financing activities:
Proceeds from ATM offering, net—
5,266,334Payments on line of credit—
(10,035,437)Cash settlement of contingent consideration(702,299)
(511,131)Payments made in connection with repurchase of common shares(61,001)
(245,868)Net cash used in financing activities(763,300)
(5,526,102)Net decrease in cash and cash equivalents(437,448)
(2,855,771)Cash and cash equivalents at beginning of period11,444,693
17,964,184Cash and cash equivalents at end of period$ 11,007,245
$ 15,108,413 CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIESReconciliation of Net Income (loss) Attributable to Common Shareholders to Adjusted Earnings (loss) and
Adjusted Diluted Earnings (loss) Per Share(Unaudited)
Three months ended March 31,
Three months ended March 31,
2026
2026
2025
2025
Earnings
impact
Earnings per
share impact
Earnings
impact
Earnings per
share impactNet income (loss) attributable to common
shareholders
$ (3,289,639)
$ (0.22)
$ 1,257,068
$ 0.08Less: Net (income) loss at subsidiary attributable to
noncontrolling interests
(2,588)
—
8,884
—Net income (loss)
(3,287,051)
(0.22)
1,248,184
0.08Adjustments to net income (loss)
Income tax expense
3,871
—
5,670
—Depreciation and amortization
1,276,283
0.09
1,031,584
0.07Share-based compensation (a)
106,842
0.01
74,212
—Interest income
(78,031)
(0.01)
(125,709)
(0.01)Interest expense
85,839
0.01
163,802
0.01Adjusted earnings (loss) per share
$ (1,892,247)
$ (0.13)
$ 2,397,743
$ 0.16
Diluted weighted-average common shares
outstanding:
14,960,210
15,259,824
Additional Information:
Reduction in the carrying amount of right-of-use
assets (b)
$ 285,184
0.02
$ 285,184
0.02The 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 of intangible and right-of-use assets, 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.(b) Represents the straight line reduction in carrying value of right-of-use assets.Adjusted Diluted Earnings (loss) Per Share: Adjusted Earnings (loss) divided by diluted weighted-average common shares outstanding. View original content:https://www.prnewswire.com/news-releases/cumberland-pharmaceuticals-reports-q1-2026-financial-results--company-update-302763267.htmlSOURCE Cumberland Pharmaceuticals Inc. Original: CUMBERLAND PHARMACEUTICALS REPORTS Q1 2026 FINANCIAL RESULTS & COMPANY UPDATE
US Market News
3月前
Joint U.S. Commercialization of RedHill's Talicia® CommencesFebruary 25, 2026 7:00 AM
PR Newswire (US)
The full sales and operational launch of Talicia, under the joint commercialization agreement between Talicia Holdings Inc. (THI), a jointly controlled entity of RedHill and Cumberland has started and is now being rolled out to support accelerated market penetration and expanded reachFocused on unlocking the full market potential of Talicia, the #1 branded U.S. gastroenterologist-prescribed H. pylori therapy1, THI and Cumberland will manage the launch and ongoing joint commercialization activitiesH. pylori infection affects 35% of the U.S. adult population and an estimated 1.6 million U.S. patients are treated annually2. Talicia is the only FDA-approved all-in-one, low-dose rifabutin-based H. pylori therapy addressing antibiotic resistance and is recommended as an empiric first-line H. pylori therapy in the American College of Gastroenterology (ACG) Clinical Guideline3RALEIGH, N.C. and TEL-AVIV, Israel, Feb. 25, 2026 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the full sales and operational launch of Talicia, under the joint commercialization agreement between Talicia Holdings Inc. ("THI") and Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), has started and is now being rolled out to support accelerated market penetration and expanded reach. This marks the operational launch of the joint commercialization model previously announced in October 2025, including Cumberland's $4 million strategic investment.
Focused on unlocking the full market potential of Talicia, the #1 branded U.S. gastroenterologist-prescribed H. pylori therapy, THI, a RedHill and Cumberland jointly controlled operating entity (70/30 RedHill/ Cumberland ownership) will manage the launch and ongoing joint commercialization, in coordination with Cumberland."H. pylori infection affects 35% of the U.S. adult population and is a leading cause of gastric cancer, responsible for approximately 11,000 related U.S. deaths a year," said Rick Scruggs, President of THI and RedHill's Chief Commercial Officer. "Patients should have access to the most effective, clinically differentiated, therapies designed to eradicate H. pylori infection on the first attempt, while mitigating the risk of antibiotic resistance. We are excited to propel Talicia into its next phase of growth in this expanding market. We are integrating key commercial resources and leveraging our combined expertise to balance stronger prescription growth with the delivery of operational efficiencies as we drive to ensure that more patients benefit from this important therapy."Talicia is the only FDA-approved all-in-one, low-dose rifabutin-based H. pylori therapy designed to address growing antibiotic resistance concerns to other available therapies. It is listed as a first-line H. pylori treatment option in the 2024 American College of Gastroenterology (ACG) Clinical Guideline, which emphasizes using 14-day, "optimized" regimens for the first attempt to maximize cure rates and avoid the need for complex, less-effective salvage therapies4. It is patent protected through 2042 and received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation. Talicia is also the only FDA-approved medication for H. pylori infection with an all-in-one formulation, with the added benefit of simple dosing.RedHill continues to work towards expanding patient access to Talicia globally. Efforts focused on potential new market entries in the UK and the Middle East, along with work to further broaden market access and secure additional non-dilutive ex-U.S. licensing revenue streams, are ongoing.About H. pylori H. pylori is a bacterial infection that affects approximately 35% of the U.S. adult population (an estimated 1.6 million U.S. patients are treated annually) rising to more than 50% globally[4]. Classified by the World Health Organization (WHO) as a Group 1 carcinogen, H. pylori is the strongest known risk factor for gastric cancer (between 70% to 90% of cases with more than 27,000 Americans diagnosed with gastric cancer annually5 and approximately 800,000 deaths globally per year), a major risk factor for peptic ulcer disease (90% of cases)6 and gastric mucosa-associated lymphoid tissue (MALT) lymphoma7. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics, especially clarithromycin, which is still commonly used in standard combination therapies8.About Talicia®Approved by the FDA for the treatment of H. pylori infection in adults in November 2019, Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole). Talicia received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents extending patent protection through 2042 with additional patents and applications pending and granted in various territories worldwide. Talicia is also approved by the United Arab Emirates (UAE) Ministry of Health.About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults9, with a recent co-commercialization agreement in the U.S. with Cumberland Pharmaceuticals. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for medical countermeasures including radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results); (iii) RHB-102, with a planned Phase 2 proof-of-concept study for GLP-1/GIP receptor agonist-associated GI intolerance, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America; and (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and also targeting multiple cancer and inflammatory gastrointestinal diseases.More information about the Company is available at www.redhillbio.com / X.com/RedHillBio.TALICIA: INDICATION AND IMPORTANT SAFETY INFORMATIONTalicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin.Talicia is contraindicated in patients receiving rilpivirine-containing products.Talicia is contraindicated in patients receiving delavirdine or voriconazole.Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Talicia.Severe cutaneous adverse reactions (SCAR) (e.g., Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin.Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins.Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis.
Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy. Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.Talicia should not be used in patients with hepatic impairment or severe renal impairment.Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease.The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at
1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Full prescribing information for Talicia is available at www.Talicia.com.Forward Looking StatementsThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words, and include, among others, statements regarding the potential impact of the relationship with Cumberland on the commercialization of Talicia. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that co-commercialization of Talicia with Cumberland may not provide the anticipated commercial and operational benefits to RedHill's global Talicia business or to RedHill's financial position, costs or its broader strategic objectives, including accelerating prescriptions, improving operational efficiencies and enabling more patients to benefit from Talicia; the risk regarding the Company's ability to maintain compliance with Nasdaq's listing requirements, including the minimum stockholders' equity requirement; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 10, 2025. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Company contact:Adi FrishChief Corporate & Business Development OfficerRedHill Biopharma+972-54-6543-112adi@redhillbio.com
Category: Corporate [1] IQVIA XPO Data on file[2] Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.[3] Chey W, Howden C, Moss S, et al. ACG Clinical Guideline: Treatment of Helicobacter pylori infection. Am J Gastroenterol. 2024;119:1730-53.[4] Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.[5] National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER).[6] Malfertheiner, P., Camargo, M.C., El-Omar, E. et al. Helicobacter pylori infection. Nat Rev Dis Primers 9, 19 (2023). https://doi.org/10.1038/s41572-023-00431-8[7] Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.[8] Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O'Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45.[9] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg
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Original: Joint U.S. Commercialization of RedHill's Talicia® Commences