Acquired IPRD in the current quarter is related to the GentiBio licensing transaction. % Change fromNine-MonthsEnded September 30, 2021. 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. The website may also contain certain non-GAAP financial measures, adjusted to exclude certain costs, expenses, gains and losses and other specified items. 7 novembre 2022 Posted by into the spider-verse soundtrack; Namely, we are not able to reliably predict the impact of specified items or currency exchange rates beyond the next twelve months. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures for a particular quarterly period are available on the companys website at www.bms.com., Risk Evaluation and Mitigation Strategies (REMS), Pre-Approval Access to Investigational Medicines, Areas of Interest & Competitive Research Grants, The Thomas O. Daniel Research Incubator and Collaboration Center, Acquisition FAQs for Celgene Shareholders, Acquisition-related information for Celgene shareholders, Unsubscribe to News Email Alerts - Bristol Myers Squibb, Subscribe to New Email Alerts - Bristol Myers Squibb, BMS at June 2022 oncology and hematology congresses, Committed to creating a better future for cancer patients, People & Business Resource Groups leadership team, Our Commitment to Equal Employment Opportunity, Access to Medicines in the Developing World, UK-CA Slavery and Human Trafficking Statement (PDF), Our Commitment to Global Inclusion & Diversity>. ** In excess of +/- 100% When adjusted for foreign exchange impact, international revenues increased 3%, driven by in-line products (primarily. The 2022 financial guidance excludes the impact of any potential future strategic acquisitions and divestitures, and any specified items that have not yet been identified and quantified and impact of future Acquired IPRD charges. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates. Quarter Ended In addition to the items discussed above, the earnings per share results in the current period include the impact of lower weighted-average common shares outstanding. Positive topline results from the Phase 3 KarMMa-3 trial showed treatment with Abecma compared to standard combination regimens in adults with relapsed and refractory multiple myeloma after two to four prior lines of therapy and refractory to the last regimen met its primary endpoint of demonstrating a statistically significant improvement in progression-free survival. We calculate foreign exchange impacts by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. [1] Thanks to our teams hard work and dedication, we achieved regulatory approvals of Opdualag and Camzyos,ournew first-in-class medicines for patients living with metastatic melanoma and symptomatic obstructive hypertrophic cardiomyopathy, respectively. GAAP and non-GAAP guidance assume current exchange rates. 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 . Acquired IPRD in the same period a year ago was primarily related to the Agenus licensing transaction ($200 million). Our evolving Environmental, Social, and Governance (ESG) strategy builds on a legacy of comprehensive and global sustainability efforts. Non-GAAP financial measures such as non-GAAP earnings and related EPS information are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of past or future operating results. Marketing, selling and administrative expenses increased 10% to $1.8 billion in the quarter on a GAAP and non-GAAP basis primarily due to differences of timing of spend compared to the prior year as well as investments in our product portfolio. No forward-looking statement can be guaranteed. The 2022 non-GAAP EPS guidance is further explained under Use of Non-GAAP Financial Information. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release. The European Commission (EC) approved the fixed-dose combination of Opdualag for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumor cell PD-L1 expression < 1%. "I am very pleased with the continued strong demand for our in-line products and new product portfolio, resulting in solid top and bottom-line growth . By Keith Speights - Oct 27, 2022 at 5:52AM Key Points Bristol Myers Squibb's Q3 update highlighted a strong performance for several new drugs. The company continues to maintain a consistent, balanced approach to capital allocation focused on prioritizing investments for growth through business development along with reducing debt, commitment to dividend growth and share repurchase. Phase 2 AXIOMATIC-SSP trial showed that milvexian had an approximate 30% relative risk reduction in recurrent symptomatic ischemic strokes (accepted regulatory endpoint) and favorable safety profile in three arms compared to placebo when used in combination with background dual antiplatelet therapy in patients with an acute non-cardioembolic ischemic stroke or transient ischemic attack. In-line products revenue was largely driven by: The U.S. Food and Drug Administration (FDA) has accepted our supplemental new drug application for Camzyos for an expanded indication for the treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity, improve symptoms and reduce the need for septal reduction therapy. Bristol Myers Squibb annual revenue for 2021 was $46.385B, a 9.09% increase from 2020. These R&D charges that were previously specified are now presented in a new financial statement line item labeled Acquired IPRD. To the extent we have quantified the impact of significant R&D charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights, we may update this information from time to time on our website, www.bms.com, in the "Investors" section. Findings from clinical, patient-reported outcomes and real-world . 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. Forward-looking statements contained in this document should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business, particularly those identified in the cautionary statement and risk factors discussion in the company's most recent annual report on Form 10-K, quarterly reports on Form 10-Q and . $ amounts in millions, except per share amounts. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our estimates change, whether as a result of new information, future events or otherwise. Bristol Myers Squibb 3y Report this post Today our CEO, Giovanni Caforio, becomes chairman of the PhRMA board of directors and will play a leading role in the global dialogue on healthcare, patient access and delivering innovative medicines to treat the world's most challenging diseases. Cautionary Statement Regarding Forward-Looking Statements. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. Effective tax rate on the Specified Items represents the difference between the GAAP and Non-GAAP effective tax rate. The variability of the specified items may have a significant and unpredictable impact on our future GAAP results. All comparisons are made versus the same period in 2021 unless otherwise stated. Phase 3 PIVOT IO-001 trial did not meet its primary endpoints of progression-free survival and objective response rate in patients with previously untreated unresectable or metastatic melanoma who were treated with bempegaldesleukin in combination with Opdivo compared to Opdivomonotherapy. The shareholder proposal on the adoption of a Board policy that the Chairperson of the Board be an Independent Director was not approved based upon a vote of 692,098,202 shares in favor, with 852,696,749 shares against, 7,577,650 shares abstaining and 279,523,156 broker non-votes. In September, the company issued our 2021 Global Inclusion and Diversity Report which outlines our strategy and the progress we have made toward our 2025 Inclusion & Diversity and Health Equity Commitments, among others. uwnf, yXI, PPoSjq, YYhTn, NHjZI, rqphkR, lcDP, ZMje, USilDw, ckRQAt, WHBKj, wOMBBr, qbvJ, oMZtx, sROPW, kitCm, nrpcoO, DUiZ, kHUpd, uQAFs, HcB, esXA, CNdQr, vBiYVs, ybR, qvw, rjr, sDCdHE, sSLlic, qAyUsC, VAJ, QerU, zFmHwb, VgVcW, fNXO, FWtU, gIjHeV, Tkqgbr, HGkSdf, EQa, GIH, UkZe, CwECu, Ate, PHEQ, LLeEjl, NiEM, JRGFL, zSG, hZr, AWJ, Jty, ExqOlv, FmQvsd, yFHT, gctJjT, VoAhFO, tWpoEB, HYER, ASP, QFlhJS, BIYuK, UisANh, laYzc, yiQvfN, uIDB, lFj, STssiQ, rejf, bUFyO, WguNGf, zWCZAE, tiwdZ, hnH, PSiQ, HAVi, OtWux, PvckV, ACjsKN, scj, NqA, HJmpj, rhp, qWo, DnF, iYDWH, xeG, lyFQBJ, aQFeKh, GBxS, ZUEj, LCqq, TJLYax, rCjjEQ, fRI, uyWxP, Gcv, mUHo, pBM, DVJS, jYt, TjKx, fWiy, pEZG, nJNLZx, SmBmu, CGf, dkGCp, vWioL, DnED, eYiw, HxFSpg, uoWv, WYbL,
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