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• | Increases Third Quarter Revenues 8% to $5.7 Billion |
• | Posts Third Quarter GAAP EPS of $1.16 and Non-GAAP EPS of $1.09 |
• | Presents Important New Clinical Data on Novel, Oral, Selective TYK2 Inhibitor for Potential Treatment of Patients with Moderate to Severe Plaque Psoriasis |
• | Additional Opdivo Approvals Including for Adjuvant Treatment of Adult Patients with Melanoma in the European Union |
• | Updates on Ongoing Regulatory Review of Opdivo Plus Low-Dose Yervoy in First-Line Lung Cancer |
• | Updates 2018 GAAP and Non-GAAP EPS Guidance |
Third Quarter | ||||||||||
$ amounts in millions, except per share amounts | ||||||||||
2018 | 2017 | Change | ||||||||
Total Revenues | $ | 5,691 | $ | 5,254 | 8 | % | ||||
GAAP Diluted EPS | 1.16 | 0.51 | ** | |||||||
Non-GAAP Diluted EPS | 1.09 | 0.75 | 45 | % |
• | Bristol-Myers Squibb posted third quarter 2018 revenues of $5.7 billion, an increase of 8% compared to the same period a year ago. Revenues increased 10% when adjusted for foreign exchange impact. |
• | U.S. revenues increased 13% to $3.2 billion in the quarter compared to the same period a year ago. International revenues increased 3%. When adjusted for foreign exchange impact, international revenues increased 6%. |
• | Gross margin as a percentage of revenue increased from 69.9% to 71.0% in the quarter primarily due to an inventory charge in the third quarter last year. |
• | Marketing, selling and administrative expenses decreased 5% to $1.1 billion in the quarter. |
• | Research and development expenses decreased 18% to $1.3 billion in the quarter primarily due to the IFM Therapeutics (IFM) acquisition charges of $310 million in the third quarter last year. |
• | The effective tax rate was 11.8% in the quarter, compared to 27.6% in the third quarter last year. The lower tax rate was due to the non-deductible IFM acquisition charges in the third quarter last year and U.S. Tax Reform. |
• | The company reported net earnings attributable to Bristol-Myers Squibb of $1.9 billion, or $1.16 per share, in the third quarter compared to net earnings of $845 million, or $0.51 per share, for the same period in 2017. |
• | The company reported non-GAAP net earnings 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 same period in 2017. An overview of specified items is discussed under the “Use of Non-GAAP Financial Information” section. |
• | Cash, cash equivalents and marketable securities were $8.8 billion, with a net cash position of $1.5 billion, as of September 30, 2018. |
• | Opdivo, which grew by $528 million or a 42% increase |
• | Eliquis, which grew by $345 million or a 28% increase |
• | Yervoy, which grew by 18% |
• | Orencia, which grew by 7% |
• | Sprycel, which decreased by 4% |
• | In October, the company provided updates regarding regulatory actions by health authorities in the U.S. and European Union for the ongoing review of its applications for an indication in metastatic first-line non-small cell lung cancer with Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) in patients with tumor mutational burden ≥10 mutations/megabase (link). |
• | In August, the company announced the U.S. Food and Drug Administration (FDA) approved Opdivo for the treatment of patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been granted under accelerated approval based on overall response rate and duration of response. |
• | In July, the company announced the European Commission approved Opdivo for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. |
• | In October, at the European Society for Medical Oncology 2018 Annual Congress, the company announced new data and analysis from studies evaluating Opdivo, Yervoy and Opdivo plus Yervoy: |
◦ | CheckMate -142: Results from a cohort of the Phase 2 trial evaluating Opdivo plus low-dose Yervoy as a first-line treatment in patients with microsatellite instability-high or DNA mismatch repair deficient metastatic colorectal cancer. (link) |
◦ | CheckMate -067: Results from the Phase 3, double-blind, randomized trial evaluating the combination of Opdivo plus Yervoy or Opdivo monotherapy versus Yervoy monotherapy in patients with previously untreated advanced melanoma. (link) |
◦ | CheckMate -214: Results from the Phase 3, randomized, open-label study evaluating the combination of Opdivo plus Yervoy versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma. (link) |
◦ | CheckMate -032: Results from the Phase 1/2 trial evaluating the safety and efficacy of Opdivo as a single agent or in combination with Yervoy in patients with previously treated locally advanced or metastatic urothelial carcinoma. (link) |
• | In October, the company announced topline results from CheckMate -331, an open-label, randomized Phase 3 trial of Opdivo versus chemotherapy in patients with relapsed SCLC after first-line platinum-based chemotherapy. (link) |
• | In August, the company announced the FDA accepted its supplemental Biologics License Application (sBLA) for Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia. |
• | In September, the company announced the European Medicines Agency validated its type II variation application for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy. |
• | In August, the company announced the FDA accepted its sBLA for Empliciti in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a PI. |
• | In August, at the 2018 European Society of Cardiology Congress, the company and Alliance partner, Pfizer, presented 15 Eliquis (apixaban) abstracts. Nine of the studies came from the global real-world data program, ACROPOLIS (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies), which now includes more than one million patient records, making this the largest body of real world evidence in existence for analyzing the effectiveness and safety of anticoagulants, including Eliquis, among patients with non-valvular atrial fibrillation and venous thromboembolism. (link) |
• | In September, at the European Academy of Dermatology and Venereology Congress, the company announced results from a Phase 2 study of BMS-986165, an investigational oral, selective TYK2 inhibitor, in patients with moderate to severe plaque psoriasis. These results were also published in the New England Journal of Medicine. (link) |
• | In October, the company and Compugen Ltd. announced a clinical trial collaboration to evaluate the safety and tolerability of Compugen’s investigational compound COM701 plus Opdivo in patients with advanced solid tumors. |
• | Worldwide revenues increasing in the high-single digits. |
• | Gross margin as a percentage of revenue to be approximately 71% for both GAAP and non-GAAP. |
• | An effective tax rate of approximately 16.5% for GAAP and approximately 17% for non-GAAP. |
Worldwide Revenues | U.S. Revenues | |||||||||||||||||||||
2018 | 2017 | % Change | 2018 | 2017 | % Change | |||||||||||||||||
Three Months Ended September 30, | ||||||||||||||||||||||
Prioritized Brands | ||||||||||||||||||||||
Opdivo | $ | 1,793 | $ | 1,265 | 42 | % | $ | 1,141 | $ | 778 | 47 | % | ||||||||||
Eliquis | 1,577 | 1,232 | 28 | % | 917 | 717 | 28 | % | ||||||||||||||
Orencia | 675 | 632 | 7 | % | 474 | 432 | 10 | % | ||||||||||||||
Sprycel | 491 | 509 | (4 | )% | 267 | 278 | (4 | )% | ||||||||||||||
Yervoy | 382 | 323 | 18 | % | 278 | 239 | 16 | % | ||||||||||||||
Empliciti | 59 | 60 | (2 | )% | 41 | 39 | 5 | % | ||||||||||||||
Established Brands | ||||||||||||||||||||||
Baraclude | 175 | 264 | (34 | )% | 6 | 14 | (57 | )% | ||||||||||||||
Sustiva Franchise | 72 | 183 | (61 | )% | 5 | 157 | (97 | )% | ||||||||||||||
Reyataz Franchise | 87 | 174 | (50 | )% | 27 | 85 | (68 | )% | ||||||||||||||
Hepatitis C Franchise | (2 | ) | 73 | ** | (4 | ) | 24 | ** | ||||||||||||||
Other Brands | 382 | 539 | (29 | )% | 83 | 101 | (18 | )% | ||||||||||||||
Total | $ | 5,691 | $ | 5,254 | 8 | % | $ | 3,235 | $ | 2,864 | 13 | % |
** | In excess of +/- 100% |
Worldwide Revenues | U.S. Revenues | |||||||||||||||||||||
2018 | 2017 | % Change | 2018 | 2017 | % Change | |||||||||||||||||
Nine Months Ended September 30, | ||||||||||||||||||||||
Prioritized Brands | ||||||||||||||||||||||
Opdivo | $ | 4,931 | $ | 3,587 | 37 | % | $ | 3,103 | $ | 2,307 | 35 | % | ||||||||||
Eliquis | 4,733 | 3,509 | 35 | % | 2,781 | 2,119 | 31 | % | ||||||||||||||
Orencia | 1,979 | 1,817 | 9 | % | 1,360 | 1,243 | 9 | % | ||||||||||||||
Sprycel | 1,464 | 1,478 | (1 | )% | 791 | 806 | (2 | )% | ||||||||||||||
Yervoy | 946 | 975 | (3 | )% | 668 | 727 | (8 | )% | ||||||||||||||
Empliciti | 178 | 168 | 6 | % | 119 | 112 | 6 | % | ||||||||||||||
Established Brands | ||||||||||||||||||||||
Baraclude | 579 | 819 | (29 | )% | 25 | 40 | (38 | )% | ||||||||||||||
Sustiva Franchise | 229 | 555 | (59 | )% | 23 | 471 | (95 | )% | ||||||||||||||
Reyataz Franchise | 328 | 555 | (41 | )% | 132 | 260 | (49 | )% | ||||||||||||||
Hepatitis C Franchise | 13 | 347 | (96 | )% | (1 | ) | 96 | ** | ||||||||||||||
Other Brands | 1,208 | 1,517 | (20 | )% | 242 | 286 | (15 | )% | ||||||||||||||
Total | $ | 16,588 | $ | 15,327 | 8 | % | $ | 9,243 | $ | 8,467 | 9 | % |
** | In excess of +/- 100% |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Net product sales | $ | 5,433 | $ | 4,862 | $ | 15,866 | $ | 14,212 | ||||||||
Alliance and other revenues | 258 | 392 | 722 | 1,115 | ||||||||||||
Total Revenues | 5,691 | 5,254 | 16,588 | 15,327 | ||||||||||||
Cost of products sold | 1,648 | 1,579 | 4,857 | 4,413 | ||||||||||||
Marketing, selling and administrative | 1,104 | 1,163 | 3,215 | 3,435 | ||||||||||||
Research and development | 1,280 | 1,561 | 4,965 | 4,543 | ||||||||||||
Other income (net) | (508 | ) | (232 | ) | (912 | ) | (1,497 | ) | ||||||||
Total Expenses | 3,524 | 4,071 | 12,125 | 10,894 | ||||||||||||
Earnings Before Income Taxes | 2,167 | 1,183 | 4,463 | 4,433 | ||||||||||||
Provision for Income Taxes | 255 | 327 | 674 | 1,129 | ||||||||||||
Net Earnings | 1,912 | 856 | 3,789 | 3,304 | ||||||||||||
Net Earnings/(Loss) Attributable to Noncontrolling Interest | 11 | 11 | 29 | (31 | ) | |||||||||||
Net Earnings Attributable to BMS | $ | 1,901 | $ | 845 | $ | 3,760 | $ | 3,335 | ||||||||
Average Common Shares Outstanding: | ||||||||||||||||
Basic | 1,632 | 1,639 | 1,633 | 1,648 | ||||||||||||
Diluted | 1,636 | 1,645 | 1,637 | 1,655 | ||||||||||||
Earnings per Common Share | ||||||||||||||||
Basic | $ | 1.16 | $ | 0.52 | $ | 2.30 | $ | 2.02 | ||||||||
Diluted | 1.16 | 0.51 | 2.30 | 2.02 | ||||||||||||
Other income (net) | ||||||||||||||||
Interest expense | $ | 44 | $ | 48 | $ | 135 | $ | 145 | ||||||||
Investment income | (44 | ) | (32 | ) | (118 | ) | (87 | ) | ||||||||
Loss/(gain) on equity investments | (97 | ) | (5 | ) | 244 | (17 | ) | |||||||||
Provision for restructuring | 45 | 28 | 102 | 207 | ||||||||||||
Litigation and other settlements | 11 | — | 10 | (489 | ) | |||||||||||
Equity in net income of affiliates | (22 | ) | (21 | ) | (73 | ) | (59 | ) | ||||||||
Divestiture (gains)/losses | (108 | ) | 1 | (178 | ) | (126 | ) | |||||||||
Royalties and licensing income | (338 | ) | (209 | ) | (1,058 | ) | (1,093 | ) | ||||||||
Transition and other service fees | — | (12 | ) | (5 | ) | (32 | ) | |||||||||
Pension and postretirement | (10 | ) | (19 | ) | (40 | ) | (29 | ) | ||||||||
Intangible asset impairment | — | — | 64 | — | ||||||||||||
Loss on debt redemption | — | — | — | 109 | ||||||||||||
Other | 11 | (11 | ) | 5 | (26 | ) | ||||||||||
Other income (net) | $ | (508 | ) | $ | (232 | ) | $ | (912 | ) | $ | (1,497 | ) |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Impairment charges | $ | — | $ | 1 | $ | 10 | $ | 128 | ||||||||
Accelerated depreciation and other shutdown costs | 13 | — | 30 | 3 | ||||||||||||
Cost of products sold | 13 | 1 | 40 | 131 | ||||||||||||
Marketing, selling and administrative | — | — | 1 | — | ||||||||||||
License and asset acquisition charges | — | 310 | 1,135 | 753 | ||||||||||||
IPRD impairments | — | — | — | 75 | ||||||||||||
Site exit costs and other | 18 | 64 | 57 | 232 | ||||||||||||
Research and development | 18 | 374 | 1,192 | 1,060 | ||||||||||||
Loss/(gain) on equity investments | (97 | ) | — | 244 | — | |||||||||||
Provision for restructuring | 45 | 28 | 102 | 207 | ||||||||||||
Litigation and other settlements | — | — | — | (481 | ) | |||||||||||
Divestiture gains | (108 | ) | — | (176 | ) | (100 | ) | |||||||||
Royalties and licensing income | — | — | (75 | ) | (497 | ) | ||||||||||
Pension and postretirement | 27 | 22 | 95 | 91 | ||||||||||||
Intangible asset impairment | — | — | 64 | — | ||||||||||||
Loss on debt redemption | — | — | — | 109 | ||||||||||||
Other income (net) | (133 | ) | 50 | 254 | (671 | ) | ||||||||||
Increase/(decrease) to pretax income | (102 | ) | 425 | 1,487 | 520 | |||||||||||
Income taxes on specified items | 1 | (41 | ) | (225 | ) | 51 | ||||||||||
Income taxes attributed to U.S. tax reform | (20 | ) | — | (49 | ) | — | ||||||||||
Income taxes | (19 | ) | (41 | ) | (274 | ) | 51 | |||||||||
Increase/(decrease) to net earnings | (121 | ) | 384 | 1,213 | 571 | |||||||||||
Noncontrolling interest | — | — | — | (59 | ) | |||||||||||
Increase/(decrease) to net earnings used for diluted Non-GAAP EPS calculation | $ | (121 | ) | $ | 384 | $ | 1,213 | $ | 512 |
Three Months Ended September 30, 2018 | Nine Months Ended September 30, 2018 | ||||||||||||||||||||||
GAAP | Specified Items(a) | Non- GAAP | GAAP | Specified Items(a) | Non- GAAP | ||||||||||||||||||
Gross Profit | $ | 4,043 | $ | 13 | $ | 4,056 | $ | 11,731 | $ | 40 | $ | 11,771 | |||||||||||
Marketing, selling and administrative | 1,104 | — | 1,104 | 3,215 | (1 | ) | 3,214 | ||||||||||||||||
Research and development | 1,280 | (18 | ) | 1,262 | 4,965 | (1,192 | ) | 3,773 | |||||||||||||||
Other income (net) | (508 | ) | 133 | (375 | ) | (912 | ) | (254 | ) | (1,166 | ) | ||||||||||||
Earnings Before Income Taxes | 2,167 | (102 | ) | 2,065 | 4,463 | 1,487 | 5,950 | ||||||||||||||||
Provision for Income Taxes | 255 | (19 | ) | 274 | 674 | (274 | ) | 948 | |||||||||||||||
Noncontrolling interest | 11 | — | 11 | 29 | — | 29 | |||||||||||||||||
Net Earnings Attributable to BMS used for Diluted EPS Calculation | $ | 1,901 | $ | (121 | ) | $ | 1,780 | $ | 3,760 | $ | 1,213 | $ | 4,973 | ||||||||||
Average Common Shares Outstanding - Diluted | 1,636 | 1,636 | 1,636 | 1,637 | 1,637 | 1,637 | |||||||||||||||||
Diluted Earnings Per Share | $ | 1.16 | $ | (0.07 | ) | $ | 1.09 | $ | 2.30 | $ | 0.74 | $ | 3.04 | ||||||||||
Effective Tax Rate | 11.8 | % | 1.5 | % | 13.3 | % | 15.1 | % | 0.8 | % | 15.9 | % | |||||||||||
Three Months Ended September 30, 2017 | Nine Months Ended September 30, 2017 | ||||||||||||||||||||||
GAAP | Specified Items(a) | Non- GAAP | GAAP | Specified Items(a) | Non- GAAP | ||||||||||||||||||
Gross Profit | $ | 3,675 | $ | 1 | $ | 3,676 | $ | 10,914 | $ | 131 | $ | 11,045 | |||||||||||
Marketing, selling and administrative | 1,163 | — | 1,163 | 3,435 | — | 3,435 | |||||||||||||||||
Research and development | 1,561 | (374 | ) | 1,187 | 4,543 | (1,060 | ) | 3,483 | |||||||||||||||
Other income (net) | (232 | ) | (50 | ) | (282 | ) | (1,497 | ) | 671 | (826 | ) | ||||||||||||
Earnings Before Income Taxes | 1,183 | 425 | 1,608 | 4,433 | 520 | 4,953 | |||||||||||||||||
Provision for Income Taxes | 327 | (41 | ) | 368 | 1,129 | 51 | 1,078 | ||||||||||||||||
Noncontrolling interest | 11 | — | 11 | (31 | ) | (59 | ) | 28 | |||||||||||||||
Net Earnings Attributable to BMS used for Diluted EPS Calculation | $ | 845 | $ | 384 | $ | 1,229 | $ | 3,335 | $ | 512 | $ | 3,847 | |||||||||||
Average Common Shares Outstanding - Diluted | 1,645 | 1,645 | 1,645 | 1,655 | 1,655 | 1,655 | |||||||||||||||||
Diluted Earnings Per Share | $ | 0.51 | $ | 0.24 | $ | 0.75 | $ | 2.02 | $ | 0.30 | $ | 2.32 | |||||||||||
Effective Tax Rate | 27.6 | % | (4.7 | )% | 22.9 | % | 25.5 | % | (3.7 | )% | 21.8 | % |
(a) | Refer to the Specified Items schedule for further details. Effective tax rate on the Specified Items represents the difference between the GAAP and Non-GAAP effective tax rate. |
September 30, 2018 | June 30, 2018 | |||||||
Cash and cash equivalents | $ | 5,408 | $ | 4,999 | ||||
Marketable securities - current | 1,422 | 1,076 | ||||||
Marketable securities - non-current | 2,017 | 2,117 | ||||||
Cash, cash equivalents and marketable securities | 8,847 | 8,192 | ||||||
Short-term debt obligations | (1,620 | ) | (1,716 | ) | ||||
Long-term debt | (5,687 | ) | (5,671 | ) | ||||
Net cash position | $ | 1,540 | $ | 805 |
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Ticker: BMYEvents:
CIK: 14272
Form Type: 8-K Corporate News
Accession Number: 0000014272-18-000194
Submitted to the SEC: Thu Oct 25 2018 8:02:30 AM EST
Accepted by the SEC: Thu Oct 25 2018
Period: Thursday, October 25, 2018
Industry: Pharmaceutical Preparations