(c) Includes amortization of purchase price adjustments to Celgene debt. What is MDS? Because the non-GAAP financial measures are not calculated in accordance with GAAP, they should not be considered superior to and are not intended to be considered in isolation or as a substitute for the related financial measures presented in the press release that are prepared in accordance with GAAP and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We made these changes to our presentation of non-GAAP financial measures following comments from and discussions with the U.S. Securities and Exchange Commission. Bristol Myers Squibb BMY -0.01% + Free Alerts today announced new two-year results from the POETYK PSO long-term extension (LTE) trial demonstrating clinical efficacy was maintained with. F/X Impact), Total In-Line Products and New Product Portfolio Revenue. BMY BMY PRESS RELEASES BMY Press Releases Published Oct 7, 2022 Bristol Myers Squibb Announces Change to Earnings Conference Call Dial-In Information for Third Quarter 2022 Results. Bristol Myers Squibb (NYSE:BMY) today reports results for the third quarter of 2022, which reflect strong in-line and new product portfolio growth. This press release features multimedia. Bristol Myers Squibb's Applications for Deucravacitinib for the Posted by By Carl November 1, 2022 Posted in Press Releases. On a non-GAAP basis, marketing, selling and administrative expenses increased 4% to $1.9 billion primarily due to higher investments to support new product launches, partially offset by foreign exchange impacts. Forward-Looking Statement of Bristol Myers Squibb. +1 (202) 335-3939. Thinking about trading options or stock in Moderna, Bristol-Myers Squibb, Northrop Grumman, BioNTech, or Tesla? On November 21, 2019, newly issued Bristol-Myers Squibb shares and CVRs will commence trading on the New York Stock Exchange, with the CVRs trading under the symbol BMYRT., This is an exciting day for Bristol-Myers Squibb as we bring together the leading science, innovative medicines and incredible talent of Bristol-Myers Squibb and Celgene to create a leading biopharma company, said Giovanni Caforio, M.D., Chairman and Chief Executive Officer of Bristol-Myers Squibb. MTEM is also eligible to receive near-term and development, regulatory and sales milestone payments of up to approximately $1.3 billion as well as tiered royalty payments on future sales. The FDA assigned a Prescription Drug User Fee Act goal date of June 16, 2023. To learn more, please visit our latest. (b) Includes amortization of purchase price adjustments to Celgene debt. Its products focus on oncology, immunology and cardiovascular conditions. Press Release (PDF) Reports Third Quarter Revenues of $11.2 Billion. Bristol-Myers Squibb expects to fund the repurchase with cash on-hand. Bristol-Myers Squibb Company Agrees to Pay $150 Million to Settle Fraud Available at. AbbVie and Bristol-Myers Squibb Announce Clinical Research These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that Reblozyl (luspatercept-aamt) may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all, that any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such product candidate for such additional indication described in this release will be commercially successful. Our nine new product launches over the last three years including three first-in-class launches this year, combined with progress in our robust and diverse product pipeline, have built a strong foundation for our company. Such forward-looking statements are based on historical performance and current expectations and projections about Bristol-Myers Squibbs future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond Bristol-Myers Squibbs control and could cause Bristol-Myers Squibbs future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. (b) Research and development charges resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights have been reclassified to the Acquired IPRD line item beginning with the first quarter of 2022. Send a Release; Sign Up; Log In; . Bristol Myers Squibb posted third quarter revenues of $11.2 billion, a decrease of 3%, driven by recent LOE products (primarily Revlimid) and foreign exchange impacts, partially offset by. 09/15/2022. New post hoc analyses from the Phase 3 True North trial evaluating duration of response following continuous Zeposia treatment for up to one year and following treatment interruption in patients with moderately to severely active ulcerative colitis showed that Zeposia prevents disease relapse over one year of continuous treatment and maintains disease control even in the event of temporary interruption. Myelodysplastic Syndrome. Quarter Ended Bristol Myers Squibb Reports Third Quarter Financial Results for 2022 The FDA approvedSotyktu, a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. While advancements have been made in the treatment of anemia for patients with myelodysplastic syndromes, there remains a significant need for new and better first-line treatment options for patients with transfusion-dependent MDS, said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb. (c) Includes Puerto Rico. There is a projected The primary objective of this trial was to detect a dose response for the composite endpoint of symptomatic ischemic stroke + MRI detected covert brain infarction across a 16-fold dose range; a dose response was not observed for the composite endpoint. With a focus on Global Sotalol Market and general market expansion and trends for 2022-2030, by Marketreports.info reports on the main elements and current market trends. Reblozyl is currently approved in the U.S. for the treatment of: Reblozyl is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Available at: Johns Hopkins Medicine. The company reported net earnings attributable to Bristol Myers Squibb of $1.6 billion, or $0.75 per share, in the third quarter, compared to $1.5 billion, or $0.69 per share, for the same period a year ago. In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) of REBLOZYL-treated patients. 2021. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Delivers Strong Revenue Growth of 8% from In-Line Products and New Product Portfolio; or 13% When Adjusted for Foreign Exchange. Such risks, uncertainties and other matters include, but are not limited to: increasing pricing pressures from market access, pharmaceutical pricing controls and discounting; changes to tax and importation laws and other restrictions in the United States, the European Union and other regions around the world that result in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse; changes under the 340B Drug Pricing Program; challenges inherent in new product development, including obtaining and maintaining regulatory approval; the companys ability to obtain and protect market exclusivity rights and enforce patents and other intellectual property rights; the possibility of difficulties and delays in product introduction and commercialization; the risk of certain novel approaches to disease treatment (such as CAR T therapy); industry competition from other manufacturers; potential difficulties, delays and disruptions in manufacturing, distribution or sale of products, including without limitation, interruptions caused by damage to the companys and the companys suppliers manufacturing sites; the impact of integrating the companys and Celgenes business and operations, including with respect to human capital management, portfolio rationalization, finance and accounting systems, sales operations and product distribution, pricing systems and methodologies, data security systems, compliance programs and internal controls processes; the risk of an adverse patent litigation decision or settlement and exposure to other litigation and/or regulatory actions; the impact of any healthcare reform and legislation or regulatory action in the United States and international markets; increasing market penetration of lower-priced generic products; the failure of the companys suppliers, vendors, outsourcing partners, alliance partners and other third parties to meet their contractual, regulatory and other obligations; regulatory decisions impacting labeling, manufacturing processes and/or other matters; the impact on the companys competitive position from counterfeit or unregistered versions of its products or stolen products; the adverse impact of cyber-attacks on the companys information systems or products, including unauthorized disclosure of trade secrets or other confidential data stored in the companys information systems and networks; the companys ability to execute its financial, strategic and operational plans; the companys ability to identify potential strategic acquisitions, licensing opportunities or other beneficial transactions; the companys dependency on several key products; any decline in the companys future royalty streams; the companys ability to effectively manage acquisitions, divestitures, alliances and other portfolio actions and to successfully realize the expected benefits of such actions; the companys ability to attract and retain key personnel; the impact of the companys significant additional indebtedness that it incurred in connection with the Celgene acquisition and the MyoKardia acquisition; political and financial instability of international economies and sovereign risk including as a result of the Russian Federation-Ukraine conflict; interest rate and currency exchange rate fluctuations, credit and foreign exchange risk management; the impact of adverse outcomes in lawsuits, claims, proceedings and government investigations; the impact of our exclusive forum provision in our by-laws for certain lawsuits on our stockholders ability to obtain a judicial forum that it finds favorable for such lawsuits; issuance of new or revised accounting standards; and risks relating to public health outbreaks, epidemics and pandemics, including the impact of the COVID-19 pandemic on the companys operations. Bristol Myers Squibb Announces Positive Topline Results of Phase 3 It is not known whether REBLOZYL is excreted into human milk or absorbed systemically after ingestion by a nursing infant. Acquired IPRD in the same period a year ago was primarily related to the Agenus licensing transaction ($200 million). About Molecular Templates. In adult patients with MDS with normal baseline blood pressure, 26 (29.9%) patients developed SBP 130 mm Hg and 23 (16.4%) patients developed DBP 80 mm Hg. All three new directors bring valuable skill sets and significant experience relevant to Bristol-Myers Squibbs business. We are pleased with the positive results of the COMMANDS study and look forward to presenting these important data.. Bristol Myers Squibb Announces Adjuvant Treatment with Opdivo (nivolumab) Demonstrated Statistically Significant and Clinically Meaningful Improvement in Recurrence-Free Survival (RFS) in Patients with Stage IIB/C Melanoma in the CheckMate -76K Trial. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2021, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange . Serious adverse reactions occurred in 3.6% of patients on REBLOZYL. These statements may be identified by the fact they use words such as should, could, expect, anticipate, estimate, target, may, project, guidance, intend, plan, believe, will and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance, although not all forward-looking statements contain such terms. Ended September 30, 2021. Forward-looking statements in this earnings release should be evaluated together with the many risks and uncertainties that affect the companys business and market, particularly those identified in the cautionary statement and risk factors discussion in the companys Annual Report on Form 10-K for the year ended December 31, 2021, as updated by the companys subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. In discussing financial results and guidance, the company refers to financial measures that are not in accordance with U.S. Generally Accepted Accounting Principles (GAAP). Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 months after the last dose. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, the company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. Bristol Myers Squibb and 2seventy bio will complete a full evaluation of the KarMMa-3 data and work with investigators to present detailed results at an upcoming medical meeting, as well as. Reblozyl, the first erythroid maturation agent, met primary and key secondary endpoints in the first-line treatment of patients with very low/low/intermediate-risk myelodysplastic syndromes PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced the COMMANDS study, a Phase 3, open-label, randomized trial evaluating Reblozyl(luspatercept-aamt), met its primary .
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