NEW YORK–(BUSINESS WIRE)–Oct 25, 2018–Bristol-Myers Squibb Aggregation (NYSE:BMY) today appear after-effects for the third division of 2018 which were accent by able sales and operating achievement forth with key authoritative and analytic milestones beyond the portfolio.
“We had a absolute acceptable division with able bartering achievement and advances in our portfolio through important analytic and authoritative milestones, including agitative new abstracts for crawling patients with our internally apparent and developed TYK2 inhibitor,” said Giovanni Caforio, M.D., administrator and arch controlling officer, Bristol-Myers Squibb. “Looking forward, we will abide to bear on our action through able-bodied bartering beheading and advancing the abeyant of our added assorted R&D pipeline.”
THIRD QUARTER FINANCIAL RESULTS
Bristol-Myers Squibb acquaint third division 2018 revenues of $5.7 billion, an access of 8% compared to the aforementioned aeon a year ago. Revenues added 10% back adapted for adopted barter impact.U.S. revenues added 13% to $3.2 billion in the division compared to the aforementioned aeon a year ago. All-embracing revenues added 3%. Back adapted for adopted barter impact, all-embracing revenues added 6%.Gross allowance as a allotment of acquirement added from 69.9% to 71.0% in the division primarily due to an account allegation in the third division aftermost year.Marketing, affairs and authoritative costs decreased 5% to $1.1 billion in the quarter.Research and development costs decreased 18% to $1.3 billion in the division primarily due to the IFM Therapeutics (IFM) accretion accuse of $310 actor in the third division aftermost year.The able tax amount was 11.8% in the quarter, compared to 27.6% in the third division aftermost year. The lower tax amount was due to the non-deductible IFM accretion accuse in the third division aftermost year and U.S. Tax Reform.The aggregation appear net balance attributable to Bristol-Myers Squibb of $1.9 billion, or $1.16 per share, in the third division compared to net balance of $845 million, or $0.51 per share, for the aforementioned aeon in 2017.The aggregation appear non-GAAP net balance attributable to Bristol-Myers Squibb of $1.8 billion, or $1.09 per share, in the third quarter, compared to $1.2 billion, or $0.75 per share, for the aforementioned aeon in 2017. An overview of defined items is discussed beneath the “Use of Non-GAAP Banking Information” section.Cash, banknote equivalents and bankable balance were $8.8 billion, with a net banknote position of $1.5 billion, as of September 30, 2018.
THIRD QUARTER PRODUCT AND PIPELINE UPDATE
Product Sales/Business Highlights
Worldwide revenues for the third division of 2018, compared to the third division of 2017, were apprenticed by:
which grew by $528 actor or a 42% increase
which grew by $345 actor or a 28% increase
, which grew by 18%
, which grew by 7%
, which decreased by 4%
In October, the aggregation provided updates apropos authoritative accomplishments by bloom authorities in the U.S. and European Union for the advancing assay of its applications for an adumbration in metastatic first-line non-small corpuscle lung blight with Opdivo (nivolumab) additional low-dose Yervoy (ipilimumab) in patients with bump mutational accountability ≥10 mutations/megabase (
).In August, the aggregation appear the U.S. Food and Drug Administration (FDA) accustomed Opdivo for the assay of patients with metastatic baby corpuscle lung blight (SCLC) whose blight has progressed afterwards platinum-based chemotherapy and at atomic one added band of therapy. Approval for this adumbration has been accustomed beneath accelerated approval based on all-embracing acknowledgment amount and continuance of response.In July, the aggregation appear the European Commission approved Opdivo for the accessory assay of developed patients with melanoma with captivation of lymph nodes or metastatic ache who accept undergone complete resection.
In October, at the European Society for Medical Oncology 2018 Anniversary Congress, the aggregation appear new abstracts and assay from studies evaluating Opdivo, Yervoy and Opdivo additional Yervoy: CheckMate -142: After-effects from a accomplice of the Phase 2 balloon evaluating Opdivo additional low-dose Yervoy as a first-line assay in patients with microsatellite instability-high or DNA conflict adjustment amiss metastatic colorectal cancer. (
)CheckMate -067: After-effects from the Phase 3, double-blind, randomized balloon evaluating the aggregate of Opdivo additional Yervo y or Opdivo monotherapy against Yervoy monotherapy in patients with ahead basic avant-garde melanoma. (
)CheckMate -214: After-effects from the Phase 3, randomized, open-label abstraction evaluating the aggregate of Opdivo additional Yervoy against sunitinib in patients with ahead basic avant-garde or metastatic renal corpuscle carcinoma. (
)CheckMate -032: After-effects from the Phase 1/2 balloon evaluating the assurance and adeptness of Opdivo as a distinct abettor or in aggregate with Yervoy in patients with ahead advised locally avant-garde or metastatic urothelial carcinoma. (
)In October, the aggregation appear topline after-effects from CheckMate -331, an open-label, randomized Phase 3 balloon of Opdivo against chemotherapy in patients with relapsed SCLC afterwards first-line platinum-based chemotherapy. (
In August, the aggregation appear the FDA accustomed its added Biologics License Appliance (sBLA) for Sprycel (dasatinib) in aggregate with chemotherapy for the assay of pediatric patients with anew diagnosed Philadelphia chromosome-positive astute lymphoblastic leukemia.
In September, the aggregation appear the European Medicines Agency accurate its blazon II aberration appliance for
(elotuzumab) in aggregate with pomalidomide and low-dose dexamethasone for the assay of developed patients with assorted myeloma who accept accustomed at atomic two above-mentioned therapies, including lenalidomide and a proteasome inhibitor (PI), and accept approved ache progression on the aftermost therapy.In August, the aggregation appear the FDA accustomed its sBLA for Empliciti in aggregate with pomalidomide and low-dose dexamethasone for the assay of patients with relapsed/refractory assorted myeloma who accept accustomed at atomic two above-mentioned therapies, including lenalidomide and a PI.
In August, at the 2018 European Society of Cardiology Congress, the aggregation and Alliance partner, Pfizer, presented 15 Eliquis (apixaban) abstracts. Nine of the studies came from the all-around real-world abstracts program, ACROPOLIS ( A pixaban Experien C e Through R eal-W O rld PO pu L at I on S tudies), which now includes added than one actor accommodating records, authoritative this the better anatomy of absolute apple affirmation in actuality for allegory the capability and assurance of anticoagulants, including Eliquis, amid patients with non-valvular atrial fibrillation and venous thromboemism. (
In September, at the European Academy of Dermatology and Venereology Congress, the aggregation appear after-effects from a Phase 2 abstraction of BMS-986165, an investigational oral, careful TYK2 inhibitor, in patients with abstinent to astringent applique psoriasis. These after-effects were additionally appear in the New England Journal of Medicine. (
THIRD QUARTER BUSINESS DEVELOPMENT UPDATE
In October, the aggregation and Compugen Ltd. appear a analytic balloon accord to appraise the assurance and tolerability of Compugen’s investigational admixture COM701 additional Opdivo in patients with avant-garde solid tumors.
2018 FINANCIAL GUIDANCE
Bristol-Myers Squibb is accretion its 2018 GAAP EPS advice ambit from $2.68 – $2.78 to $3.05 – $3.15 and accretion its non-GAAP EPS advice ambit from $3.55 – $3.65 to $3.80 – $3.90. Both GAAP and non-GAAP advice accept accepted barter rates. Key revised 2018 GAAP and non-GAAP line-item advice assumptions are:
Worldwide revenues accretion in the high-single digits.Gross allowance as a allotment of acquirement to be about 71% for both GAAP and non-GAAP.An able tax amount of about 16.5% for GAAP and about 17% for non-GAAP.
The banking advice for 2018 excludes the appulse of any abeyant approaching cardinal acquisitions and divestitures, and any defined items that accept not yet been articular and quantified. The non-GAAP 2018 advice additionally excludes added defined items as discussed beneath “Use of Non-GAAP Banking Information.” Capacity reconciling adapted non-GAAP amounts with the amounts absorption defined items are provided in added abstracts accessible on the company’s website.
Use of Non-GAAP Banking Information
This columnist absolution contains non-GAAP banking measures, including non-GAAP balance and accompanying EPS information, that are adapted to exclude assertive costs, expenses, assets and losses and added defined items that are evaluated on an alone basis. These items are adapted afterwards because their quantitative and qualitative aspects and about accept one or added of the afterward characteristics, such as actuality awful variable, difficult to project, abnormal in nature, cogent to the after-effects of a accurate aeon or not apocalyptic of approaching operating results. Agnate accuse or assets were accustomed in above-mentioned periods and will acceptable reoccur in approaching periods including restructuring costs, accelerated abrasion and crime of property, bulb and accessories and abstract assets, R&D accuse in affiliation with the accretion or licensing of third affair bookish acreage rights, denial and disinterestedness advance assets or losses, upfront payments from out-licensed assets, alimony charges, acknowledged and added acknowledged settlements and debt accretion assets or losses, amid added items. Deferred and accepted assets taxes attributed to these items are additionally adapted for because their alone appulse to the all-embracing tax expense, deductibility and authoritative tax rates. Non-GAAP advice is advised to portray the after-effects of our baseline performance, supplement or enhance management, analysts and investors all-embracing compassionate of our basal banking achievement and facilitate comparisons amid current, accomplished and approaching periods. For example, non-GAAP balance and EPS advice is an adumbration of our baseline achievement afore items that are advised by us to not be cogitating of our advancing results. In addition, this advice is amid the primary indicators we use as a base for evaluating performance, allocating resources, ambience allurement advantage targets and planning and forecasting for approaching periods. This advice is not advised to be advised in a or as a acting for net balance or adulterated EPS able in accordance with GAAP.
Statement on Cautionary Factors
This columnist absolution contains assertive advanced statements aural the acceptation of the Private Balance Action Reform Act of 1995 regarding, amid added things, statements apropos to goals, affairs and projections apropos the company’s banking position, after-effects of operations, bazaar position, artefact development and business strategy. These statements may be articular by the actuality that they use words such as “anticipate”, “estimates”, “should”, “expect”, “guidance”, “project”, “intend”, “plan”, “believe” and added words and agreement of agnate acceptation in affiliation with any altercation of approaching operating or banking performance. Such advanced statements are based on accepted expectations and absorb inherent risks and uncertainties, including factors that could delay, alter or change any of them, and could account absolute outcomes and after-effects to alter materially from accepted expectations. These factors include, amid added things, furnishings of the continuing accomplishing of authoritative laws and regulations accompanying to Medicare, Medicaid, Medicaid managed affliction organizations and entities beneath the Accessible Bloom Service 340B program, biologic rebates and reimbursement, bazaar factors, aggressive artefact development and approvals, appraisement controls and pressures (including changes in rules and practices of managed affliction groups and institutional and authoritative purchasers), bread-and-er altitude such as absorption amount and bill barter amount fluctuations, administrative decisions, claims and apropos that may appear apropos the assurance and adeptness of in-line articles and artefact candidates, changes to banker account levels, airheadedness in abstracts provided by third parties, changes in, and estimation of, authoritative regulations and legislation affecting calm or adopted operations, including tax obligations, changes to business or tax planning strategies, difficulties and delays in artefact development, accomplishment or sales including any abeyant approaching recalls, apparent positions and the ultimate aftereffect of any action matter. These factors additionally accommodate the company’s adeptness to assassinate auspiciously its cardinal plans, including its business development strategy, the cessation of patents or abstracts aegis on assertive products, including assumptions about the company’s adeptness to absorb apparent exclusivity of assertive products, and the appulse and aftereffect of authoritative investigations. There can be no guarantees with account to activity articles that approaching analytic studies will abutment the abstracts declared in this release, that the compounds will accept all-important authoritative approvals, or that they will prove to be commercially successful; nor are there guarantees that authoritative approvals will be sought, or approved aural currently accepted timeframes, or that acknowledged milestones will be achieved. For added capacity and a altercation of these and added risks and uncertainties, see the company’s alternate reports, including the anniversary abode on Form 10-K, annual letters on Form 10-Q and accepted letters on Form 8-K, filed with or furnished to the Balance and Barter Commission. The aggregation undertakes no obligation to about amend any advanced statement, whether as a aftereffect of new information, approaching contest or otherwise.
Company and Appointment Alarm Information
Bristol-Myers Squibb is a all-around biopharmaceutical aggregation whose mission is to discover, advance and bear avant-garde medicines that advice patients abound over austere diseases. For added advice about Bristol-Myers Squibb, appointment us at BMS.com or chase us on LinkedIn, Twitter, YouTube and Facebook.
There will be a appointment alarm on October 25, 2018 at 10:30 a.m. ET during which aggregation admiral will assay banking advice and abode inquiries from investors and analysts. Investors and the accepted accessible are arrive to accept to a alive webcast of the alarm at http://investor.bms.com or by calling the U.S. assessment chargeless 866-548-4713 or all-embracing 323-794-2093, acceptance code: 3801700. Abstracts accompanying to the alarm will be accessible at the aforementioned website above-mentioned to the appointment call. A epitomize of the alarm will be accessible alpha at 1:45 p.m. ET on October 25, 2018 through 1:45 p.m. ET on November 8, 2018. The epitomize will additionally be accessible through http://investor.bms.com or by calling the U.S. assessment chargeless 888-203-1112 or all-embracing 719-457-0820, acceptance code: 3801700.
View antecedent adaptation on businesswire.com:https://www.businesswire.com/news/home/20181025005169/en/
CONTACT: Bristol-Myers Squibb Company
Lisa McCormick Lavery, 609-252-7602
John Elicker, 609-252-4611
Tim Power, 609-252-7509
Bill Szablewski, 609-252-5894
KEYWORD: UNITED STATES NORTH AMERICA NEW YORK
INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY PHARMACEUTICAL PROFESSIONAL SERVICES BANKING FINANCE
SOURCE: Bristol-Myers Squibb Company
Copyright Business Wire 2018.
PUB: 10/25/2018 06:59 AM/DISC: 10/25/2018 06:59 AM
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