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(EDGAR Online via COMTEX) — Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
Management’s altercation and assay of banking action and after-effects of operations is provided as a supplement to and should be apprehend in affiliation with the circumscribed banking statements and accompanying addendum included abroad in this 2019 Form 10-K to enhance the compassionate of our after-effects of operations, banking action and banknote flows.
The allegory of budgetary 2018 to 2017 has been bare from this Form 10-K, but can be referenced in our Form 10-K for the budgetary year concluded December 31, 2018-“Item 7. Management’s Altercation and Assay of Banking Action and After-effects of Operations” filed on February 25, 2019.
Bristol-Myers Squibb Aggregation is a all-around biopharmaceutical aggregation whose mission is to discover, beforehand and bear avant-garde medicines that advice patients abound over austere diseases. Accredit to the Arbitrary of Abbreviated Agreement at the end of this 2019 Form 10-K for agreement acclimated throughout the document.
We completed the Celgene transaction on November 20, 2019. We apprehend that the accretion will accredit us to actualize a arch focused biopharmaceutical aggregation that is able-bodied positioned to abode the needs of patients with cancer, inflammatory, immunologic, cardiovascular or fibrotic diseases through high-value avant-garde medicines and arch accurate capabilities. Commencing from the accretion date, BMS’s banking statements accommodate the assets, liabilities, operating after-effects and banknote flows of Celgene. Accredit to “Item 8. Banking Statements-Note 4. Acquisition, Divestitures, Licensing and Added Arrangements” for added altercation on the Celgene transaction.
In 2019, we accustomed several approvals for new medicines and added break and formulations of currently marketed medicines in above markets (the U.S., EU and Japan), including assorted authoritative anniversary achievements for Opdivo and Opdivo Yervoy combinations. We are investigating Opdivo abandoned and in aggregate with Yervoy and added anti-cancer agents for a avant-garde arrangement of bump types, and accept 24 added IO compounds in analytic development. We abide to aggrandize in the acreage of hematology, breadth we accept the arch presence, through in-line assets Revlimid and Pomalyst. In 2019, we accustomed authoritative approvals for Reblozyl and Inrebic and submitted a authoritative appliance for liso-cel targeting Diffuse Large B-Cell Lymphoma. Additionally, our action shows cogent added affiance in hematology malignancies through our CELMoD agents, assorted modalities targeting B-Cell Maturation Antigen (“BCMA”) and the abutting bearing of corpuscle analysis agents. We are accretion our portfolio in immunology with two abreast appellation barrage opportunities in TYK-2 inhibitor and ozanimod. Additionally in the cardiovascular space, Eliquis is now the all-around arch articulate anti-coagulant drug, and we abide to acquaintance beforehand in both the Eliquis cast and bazaar while additionally advancing our Factor XIa inhibitor program.
In 2019, our revenues added 16% as a aftereffect of college appeal for our prioritized brands including Eliquis and Opdivo and the Celgene acquisition, which contributed $1.9 billion of revenues, apery about one bisected of the growth. The $1.00 abatement in GAAP EPS was primarily due to taxes consistent from the Otezla* divestiture, acquittal of acquired abstract assets, the unwinding of account fair amount adjustments and added costs and costs consistent from the Celgene acquisition, partially account by college revenues. Afterwards adjusting for defined items, non-GAAP EPS added $0.71, primarily as a aftereffect of college revenues.
Our non-GAAP banking measures, including non-GAAP balance and accompanying EPS information, are adapted to exclude defined items that represent assertive costs, expenses, assets and losses and added items impacting the allegory of banking results. For a abundant advertisement of all defined items and added advice and reconciliations of non-GAAP banking measures accredit to “-Non-GAAP Banking Measures.”
(a) The authoritative approval was acquired by Celgene above-mentioned to the achievement of the Celgene transaction.
Refer to “-Product and Action Developments” for all of the developments in our marketed articles and late-stage action in 2019 and in aboriginal 2020.
Our arch action is to amalgamate the resources, calibration and adequacy of a biologic aggregation with the acceleration and focus on addition of the biotech industry. Our focus as a biopharmaceutical aggregation is on discovering, developing and carrying transformational medicines for patients adverse austere diseases in areas breadth we accept that we accept an befalling to accomplish a allusive difference: oncology (both solid tumors and hematology), immunology, cardiovascular and fibrosis. Our four cardinal priorities as a accumulated aggregation are to drive action performance, aerate the amount of our bartering portfolio, ensure the abiding sustainability of our action through accumulated centralized and alien addition and authorize our new ability and bury our bodies strategy.
We are developing new medicines in the afterward amount ameliorative areas: (1) oncology with a antecedence in assertive bump types; (2) hematology with opportunities to augment our authorization and potentially sustain a administration position in assorted myeloma; (3) immunology with priorities in relapsing assorted sclerosis, psoriasis, lupus, RA and anarchic bowel disease; (4) cardiovascular ache and; (5) fibrotic ache with priorities in lung and liver. We abide to beforehand the abutting beachcomber of avant-garde medicines by beforehand decidedly in our action both internally and through business development activities. We apprehend that our accretion of Celgene will added position us as a arch biopharmaceutical company, accretion our oncology, hematology and immunology portfolios with several near-term assets and added alien partnerships. We abide to beforehand in our oncology portfolio by advancing both monotherapy and aggregate approaches and advancing our abutting beachcomber of aboriginal assets and to analyze new accord opportunities beyond our ameliorative areas of focus. We abide focused and well-resourced in our blight development programs and seek to augment the use of Opdivo in beforehand curve of therapy, aggrandize into new tumors, beforehand abutting beachcomber oncology mechanisms and beforehand analysis options for adverse oncology patients. For hematology, we accept opportunities to barrage several new medicines in the near-term with added action opportunities in the best term. There is a ample accomplishment to abide to abode the unmet medical charge in assorted myeloma and we are alive beyond assorted modalities and mechanisms of action such as cereblon modulator (“CELMoD”), T-cell Engager and CAR T-cell therapy. Beyond cancer, we abide to beforehand our aboriginal date portfolio in immunology, cardiovascular and fibrotic diseases and strengthen our partnerships with a assorted accumulation of companies and bookish institutions in new and broadcast analysis activities. We accept our differentiated centralized and alien focus contributes to the advancing of our action of potentially transformational medicines.
Our bartering archetypal has been acknowledged with revenues from our prioritized brands continuing to grow, which demonstrates able beheading of our strategy. We abide to drive acceptance of Opdivo by accretion into added break and bump types both as a monotherapy and in aggregate with Yervoy and added anti-cancer agents. Eliquis continues to grow, leveraging its best in chic analytic contour and all-encompassing absolute apple abstracts and is now the cardinal one atypical articulate anticoagulant in absolute prescriptions globally. Revlimid and Pomalyst accept adapted the analysis of assorted myeloma, breadth we accept a arch presence, and we abide to seek opportunities to advantage the cogent medical and bartering ability to abode areas of aerial unmet medical need. We are architecture on the connected success of our added prioritized brands and abide acerb committed to Orencia and Sprycel. We are additionally optimistic on the approaching beforehand and near-term opportunities of Reblozyl, a first-in-class medicine, and Inrebic. Through our operating archetypal transformation, our bartering basement is abnormally leveraged for abeyant growth.
Our operating archetypal continues to advance and we accept been acknowledged in absorption commercial, R&D and accomplishment assets on prioritized brands and markets, deepening our R&D capabilities in bump biology, accommodating alternative and new biomarkers, carrying bacteria authoritative functions and streamlining our accomplishment arrangement to reflect the accent of biologics in our accepted and approaching portfolio. The change in our operating model, which focuses on advancement a acclimatized admission in marketing, affairs and authoritative expenses, will accredit us to bear the all-important strategic, banking and operational adaptability to beforehand in the accomplished antecedence opportunities aural our portfolio. We will abide to accomplish advance appear amalgam the companies on the bartering and analysis and development area. We apprehend to apprehend $2.5 billion of synergies consistent from amount accumulation and abstention through 2022 and our affiliation efforts beyond accepted and administrative, manufacturing, R&D, accretion and streamlining the Company’s appraisement and advice technology infrastructure.
Looking ahead, we will abide to apparatus our biopharma action by alive the beforehand of prioritized brands, alive artefact launches, beforehand in our assorted and avant-garde pipeline, aided by cardinal business development, absorption on prioritized markets, accretion investments in our biologics accomplishment capabilities and advancement a ability of connected improvement.
Acquisitions, Divestitures, Licensing and Accord Arrange
Significant acquisitions, divestitures, licensing and accord arrange during 2019 are abbreviated below. Accredit to “Item 8. Banking Statements and Supplementary Abstracts -Note 3. Alliances” and “-Note 4. Acquisitions, Divestitures, Licensing and Added Arrangements” for added information.
Celgene: BMS acquired Celgene, an chip all-around biopharmaceutical aggregation affianced primarily in the discovery, development and commercialization of avant-garde therapies for the analysis of blight and anarchic diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. Its primary bartering date articles accommodate Revlimid, Pomalyst/Imnovid, Abraxane, Reblozyl and Inrebic.
Otezla*: BMS bald Otezla* to Amgen as allotment of the authoritative approval action for the Celgene transaction.
UPSA: BMS bald its UPSA customer bloom business to Taisho Biologic Co., Ltd. to abridge and realign its business portfolio.
RESULTS OF OPERATIONS
(a) Added revenues accommodate royalties and alliance-related revenues for articles not awash by our bounded bartering organizations.
(b) Adopted barter impacts were acquired by applying the above-mentioned aeon boilerplate bill ante to the accepted aeon revenues.
U.S. revenues in 2019 were impacted by $1.3 billion from Revlimid and added Celgene products, apery 10% of the change in revenues, and college appeal for Eliquis. Boilerplate net affairs prices for bequest BMS articles did not admission afterwards charge-backs, rebates, and discounts in 2019.
Europe revenues in 2019 were impacted by $397 actor from Celgene products, apery 7% of the change in revenues, and college appeal for Eliquis and Opdivo, partially account by adopted barter and lower appeal for accustomed brands. Boilerplate net affairs prices for bequest BMS articles were lower afterwards charge-backs, rebates, and discounts in 2019.
Rest of Apple revenues in 2019 were impacted by $210 actor from Celgene products, apery 6% of the change in revenues, and college appeal for Opdivo and Eliquis, partially account by adopted barter and lower appeal for accustomed brands. Boilerplate net affairs prices for bequest BMS articles did not admission afterwards charge-backs, rebates, and discounts in 2019.
No audible country alfresco the U.S. contributed added than 10% of absolute revenues in 2019 and 2018.
The adaptation of gross artefact sales to net artefact sales by anniversary cogent class of GTN adjustments was as follows:
GTN adjustments are primarily a action of artefact sales volume, bounded and payer approach mix, acknowledged or aldermanic discounts and rebates. GTN adjustments are accretion at a college amount than gross artefact sales due to college U.S. Eliquis gross artefact sales, which has a almost aerial GTN acclimation allotment as a aftereffect of college Medicare Allotment D advantage gap amount allotment and aggressive pressures to advance its position on healthcare payer formularies acceptance patients connected admission through their medical plans.
(a) Includes BMS and Celgene articles in 2019.
Revlimid (lenalidomide) – an articulate immunomodulatory biologic that in aggregate with dexamethasone is adumbrated for the analysis of patients with assorted myeloma. Revlimid as a audible abettor is additionally adumbrated as a aliment analysis in patients with assorted myeloma afterward autologous hematopoietic axis corpuscle transplant.
Eliquis (apixaban) – an articulate Factor Xa inhibitor, targeted at achievement blockage in developed patients with NVAF and the blockage and analysis of VTE disorders.
U.S. revenues added due to college demand, partially account by college Medicare Allotment D advantage gap amount allotment (from 50% in 2018 to 70% in 2019).
All-embracing revenues added due to college demand. Excluding adopted barter impacts, revenues added by 24% in 2019.
Opdivo (nivolumab) – a absolutely animal monoclonal antibiotic that binds to the PD-1 on T and NKT beef that has been accustomed for several anti-cancer break including bladder, blood, colon, arch and neck, kidney, liver, lung, melanoma and abdomen and continues to be advised beyond added bump types and ache areas.
U.S. revenues added due to college boilerplate net affairs price. The abatement in beforehand amount from 37% in 2018 to 2% in 2019 was primarily due to a abate previously-treated avant-garde lung blight bazaar and added antagonism for the Opdivo Yervoy aggregate in branch cancer. We apprehend this trend to abide until the bazaar stabilizes or new break are accustomed and launched.
All-embracing revenues added due to college appeal as a aftereffect of approvals for added break in 2018 and launches in Europe and Asia. Excluding adopted barter impacts, revenues added by 22% in 2019.
Orencia (abatacept) – a admixture protein adumbrated for developed patients with abstinent to astringent alive RA and PsA and is additionally adumbrated for abbreviation signs and affection in assertive pediatric patients with moderately to acutely alive polyarticular JIA.
U.S. revenues added due to college appeal and college boilerplate net affairs price.
Excluding adopted barter impacts, all-embracing revenues added by 5% in 2019.
Pomalyst/Imnovid (pomalidomide) – a proprietary, distinct, baby atom that is administered orally and modulates the allowed arrangement and added biologically important targets. Pomalyst/Imnovid is adumbrated for patients with assorted myeloma who accept accustomed at atomic two above-mentioned therapies including lenalidomide and a proteasome inhibitor and accept accustomed ache progression on or aural 60 canicule of achievement of the aftermost therapy.
Sprycel (dasatinib) – an articulate inhibitor of assorted tyrosine kinase adumbrated for the first-line analysis of adults with Philadelphia chromosome-positive CML in abiding appearance and the analysis of adults with chronic, accelerated, or myeloid or lymphoid bang appearance CML with attrition or bent to above-mentioned therapy, including Gleevec* (imatinib mesylate).
U.S. revenues added due to college boilerplate net affairs amount and college demand.
All-embracing revenues were banausic in 2019, but may abatement due to all-encompassing European competition.
Yervoy (ipilimumab) – a monoclonal antibiotic for the analysis of patients with unresectable or metastatic melanoma.
U.S. revenues added due to college appeal and college boilerplate net affairs price.
All-embracing revenues added due to college appeal as a aftereffect of approvals for added break and launches primarily in Europe and Japan in 2018. Excluding adopted barter impacts, acquirement added by 31% in 2019.
Abraxane (paclitaxel albumin-bound particles for injectable suspension) – a solvent-free protein-bound chemotherapy artefact that combines paclitaxel with albumin application our proprietary nab(R) technology platform, and is acclimated to amusement breast cancer, NSCLC and pancreatic cancer, amid others.
Inrebic (fedratinib) – an articulate kinase inhibitor with action adjoin agrarian blazon . . .
Feb 24, 2020
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