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• | Reported third quarter sales of $2.393 billion, compared to the company's guidance range of $2.380 to $2.420 billion, representing an increase of 7.7 percent on a reported basis, 9.1 percent on an operational basis and 8.7 percent on an organic basis, all compared to the prior year period. |
• | Reported GAAP earnings of $0.31 per share compared to the company's guidance range of $0.21 to $0.23 per share. Achieved adjusted earnings per share of $0.35 compared to the guidance range of $0.33 to $0.35 per share. |
• | Achieved third quarter revenue growth in all segments, compared to the prior year period: |
◦ | MedSurg: 10.3 percent reported, 11.7 percent operational and 11.0 percent organic |
◦ | Rhythm and Neuro: 7.4 percent reported, 8.3 percent operational and organic |
◦ | Cardiovascular: 5.9 percent reported, 7.7 percent operational and 7.2 percent organic |
• | Delivered revenue growth in all regions, compared to the prior year period: |
◦ | U.S.: 9.4 percent reported and operational |
◦ | EMEA (Europe, Middle East and Africa): 5.1 percent reported and 7.4 percent operational |
◦ | APAC (Asia-Pacific): 6.2 percent reported and 8.1 percent operational |
◦ | Emerging Markets3: 11.1 percent reported and 19.7 percent operational |
• | Received U.S. Food and Drug Administration (FDA) approval for the Eluvia™ Drug-Eluting Vascular Stent System, following the release of positive 12-month data from the IMPERIAL trial, the first head-to-head drug-eluting stent (DES) trial for obstructive disease of the superficial femoral artery. Patients treated with the Eluvia stent experienced superior clinical outcomes when compared to those treated with Zilver PTX (Cook Medical). IMPERIAL data were presented simultaneously at the 30th |
• | Submitted the premarket approval (PMA) application for the LOTUS Edge™ Aortic Valve System4, which included the filing of the final technical module. |
• | Began enrollment in the SAVAL Trial, studying the SAVAL™ Below the Knee (BTK) Drug-Eluting Stent System, which is designated for the FDA Breakthrough Device protocol and is the first stent designed to treat critical limb ischemia. |
• | Received FDA approval for the Promus ELITE™ Everolimus-Eluting Platinum Chromium Coronary Stent System, an enhanced permanent polymer DES (PP-DES) therapy offering for physicians who choose PP-DES as a treatment option for their patients. |
• | Received FDA approval for the VISIONIST™ X4 Cardiac Resynchronization Therapy Pacemaker (CRT-P) and RELIANCE 4-FRONT™ Defibrillation Lead in the U.S. Both products also received MR-conditional labeling and are a part of the Rhythm Management ImageReady™ MR-conditional Systems portfolio with offerings now approved and available in all high and low-voltage device categories. |
• | Received determination from the District Court of Dusseldorf, Germany that Edwards Lifesciences Corporation’s Sapien 3 Ultra™ device infringed a patent established by Symetis SA, a subsidiary of Boston Scientific. The Court ruled in preliminary injunction proceedings that Boston Scientific has the right to enjoin Edwards and its German subsidiary from offering and selling Sapien 3 Ultra in Germany. |
• | Presented two-year EWOLUTION real world registry data on the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device as a late-breaking clinical trial at the European Society of Cardiology Congress and as a keynote presentation at TCT 2018. Data demonstrated the WATCHMAN Device continues to be a safe and effective alternative to long-term warfarin therapy, offering comparable stroke risk reduction and a significantly reduced risk of major bleeding for patients with non-valvular atrial fibrillation (AF). |
• | Completed enrollment in PINNACLE FLX, the prospective, multi-center clinical trial of the WATCHMAN FLX™ LAAC Device. The newest generation LAAC device is designed to treat a wider range of patient anatomies, increase ease of use, and improve sealing and healing within the left atrial appendage. |
• | Launched the LithoVue Empower™ Retrieval Deployment Device, designed to enable individual urologists to remove kidney stones via flexible ureteroscopy (URS) by simultaneously controlling the ureteroscope and nitinol retrieval basket without a second clinician. |
• | Launched the GUIDE™ XT System for visualization of Deep Brain Stimulation (DBS) in Europe. The GUIDE XT System is the first DBS visualization system built for directionality that utilizes patient specific anatomy and stimulation field modeling. This technology provides physicians with 3-D image planning capability and when used in conjunction with the Vercise™ DBS Systems, enables physicians to personalize and optimize DBS treatment. |
• | Closed the acquisition of Claret Medical, Inc., a privately-held company that has developed and commercialized the Sentinel® Cerebral Embolic Protection System, used to protect the brain during certain interventional procedures, predominately in patients undergoing transcatheter aortic valve replacement (TAVR), and received a New Technology Add-on Payment (NTAP) designation for the Sentinel System from the U.S. Centers for Medicare and Medicaid Services (CMS). |
• | Closed the acquisition of VENITI, Inc., a privately-held company that has developed and commercialized the VICI VENOUS STENT® System for treating venous obstructive disease. |
• | Closed the acquisition of Augmenix, Inc., a privately-held company that has developed and commercialized the SpaceOAR® System, a therapy used to reduce common and debilitating side effects that men may experience after receiving prostate cancer radiotherapy. |
Change | ||||||||||||||||||||||
Three Months Ended September 30, | Reported Basis | Less: Impact of Foreign Currency Fluctuations | Operational Basis | Less: Impact of Recent Acquisitions | Organic Basis | |||||||||||||||||
(in millions) | 2018 | 2017 | ||||||||||||||||||||
Endoscopy | $ | 443 | $ | 403 | 10.1 | % | (1.5 | )% | 11.6 | % | — | % | 11.6 | % | ||||||||
Urology and Pelvic Health | 303 | 274 | 10.7 | % | (1.2 | )% | 11.9 | % | 1.9 | % | 10.0 | % | ||||||||||
MedSurg* | 746 | 676 | 10.3 | % | (1.4 | )% | 11.7 | % | 0.7 | % | 11.0 | % | ||||||||||
Cardiac Rhythm Management | 475 | 463 | 2.3 | % | (0.9 | )% | 3.2 | % | — | % | 3.2 | % | ||||||||||
Electrophysiology | 76 | 71 | 7.6 | % | (1.0 | )% | 8.6 | % | — | % | 8.6 | % | ||||||||||
Neuromodulation | 189 | 154 | 22.8 | % | (0.7 | )% | 23.5 | % | — | % | 23.5 | % | ||||||||||
Rhythm and Neuro* | 740 | 689 | 7.4 | % | (0.9 | )% | 8.3 | % | — | % | 8.3 | % | ||||||||||
Interventional Cardiology | 615 | 589 | 4.4 | % | (1.9 | )% | 6.3 | % | 0.7 | % | 5.6 | % | ||||||||||
Peripheral Interventions | 293 | 268 | 9.2 | % | (1.5 | )% | 10.7 | % | — | % | 10.7 | % | ||||||||||
Cardiovascular | 908 | 857 | 5.9 | % | (1.8 | )% | 7.7 | % | 0.5 | % | 7.2 | % | ||||||||||
Net Sales | $ | 2,393 | $ | 2,222 | 7.7 | % | (1.4 | )% | 9.1 | % | 0.4 | % | 8.7 | % | ||||||||
*Prior period segment amounts revised in accordance with ASC 280, Segment Reporting, to reflect the reclassification of Neuromodulation from the MedSurg segment to the Rhythm and Neuro segment, effective January 1, 2018. |
Change | ||||||||||||||||
Three Months Ended September 30, | Reported Basis | Less: Impact of Foreign Currency Fluctuations | Operational Basis | |||||||||||||
(in millions) | 2018 | 2017 | ||||||||||||||
U.S. | $ | 1,375 | $ | 1,257 | 9.4 | % | — | % | 9.4 | % | ||||||
EMEA** | 498 | 474 | 5.1 | % | (2.3 | )% | 7.4 | % | ||||||||
APAC** | 425 | 401 | 6.2 | % | (1.9 | )% | 8.1 | % | ||||||||
Latin America and Canada | 94 | 91 | 3.7 | % | (14.3 | )% | 18.0 | % | ||||||||
Net Sales | $ | 2,393 | $ | 2,222 | 7.7 | % | (1.4 | )% | 9.1 | % | ||||||
Emerging Markets | $ | 263 | $ | 236 | 11.1 | % | (8.6 | )% | 19.7 | % | ||||||
**Regional totals reflect the reclassification of Middle East and Africa from the former AMEA region to Europe, effective January 1, 2018. | ||||||||||||||||
Amounts may not add due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely. | ||||||||||||||||
Sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of recent acquisitions are not prepared in accordance with U.S. GAAP. | ||||||||||||||||
CONTACT: | ||||
Media: | Kate Haranis | Investors: | Susie Lisa, CFA | |
508-683-6585 (office) | 508-683-5565 (office) | |||
Media Relations | Investor Relations | |||
Boston Scientific Corporation | Boston Scientific Corporation | |||
kate.haranis@bsci.com | BSXInvestorRelations@bsci.com |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||
in millions, except per share data | 2018 | 2017 | 2018 | 2017 | |||||||||
Net sales | $ | 2,393 | $ | 2,222 | $ | 7,262 | $ | 6,640 | |||||
Cost of products sold | 672 | 637 | 2,084 | 1,919 | |||||||||
Gross profit | 1,720 | 1,585 | 5,179 | 4,721 | |||||||||
Operating expenses: | |||||||||||||
Selling, general and administrative expenses | 870 | 800 | 2,616 | 2,408 | |||||||||
Research and development expenses | 289 | 254 | 825 | 734 | |||||||||
Royalty expense | 17 | 16 | 52 | 50 | |||||||||
Amortization expense | 148 | 139 | 437 | 424 | |||||||||
Intangible asset impairment charges | — | 3 | 35 | 3 | |||||||||
Contingent consideration expense (benefit) | (13 | ) | (4 | ) | (12 | ) | (78 | ) | |||||
Restructuring charges (credits) | 3 | 12 | 20 | 17 | |||||||||
Litigation-related net charges (credits) | 18 | (12 | ) | 18 | 196 | ||||||||
1,333 | 1,208 | 3,992 | 3,754 | ||||||||||
Operating income (loss) | 388 | 377 | 1,187 | 967 | |||||||||
Other income (expense): | |||||||||||||
Interest expense | (58 | ) | (57 | ) | (177 | ) | (172 | ) | |||||
Other, net | 126 | (11 | ) | 116 | (89 | ) | |||||||
Income (loss) before income taxes | 456 | 309 | 1,126 | 706 | |||||||||
Income tax expense (benefit) | 24 | 26 | (159 | ) | (13 | ) | |||||||
Net income (loss) | $ | 432 | $ | 283 | $ | 1,285 | $ | 719 | |||||
Net income (loss) per common share - basic | $ | 0.31 | $ | 0.21 | $ | 0.93 | $ | 0.53 | |||||
Net income (loss) per common share - assuming dilution | $ | 0.31 | $ | 0.20 | $ | 0.92 | $ | 0.52 | |||||
Weighted-average shares outstanding | |||||||||||||
Basic | 1,382.8 | 1,372.0 | 1,380.0 | 1,369.1 | |||||||||
Assuming dilution | 1,403.9 | 1,394.1 | 1,399.8 | 1,391.8 |
Three Months Ended September 30, 2018 | ||||||||||||||||||||||||||||
in millions, except per share data | Cost of Products Sold | SG&A Expenses | R&D Expenses | Operating Income (Loss) | Pre-Tax Income (Loss) | Net Income (Loss) | Impact per Share | |||||||||||||||||||||
GAAP net income (loss) | $ | 672 | $ | 870 | $ | 289 | $ | 388 | $ | 456 | $ | 432 | $ | 0.31 | ||||||||||||||
Non-GAAP adjustments: | ||||||||||||||||||||||||||||
Amortization expense | — | — | — | 148 | 148 | 132 | 0.09 | |||||||||||||||||||||
Acquisition-related net charges (credits) | (9 | ) | (19 | ) | (29 | ) | 44 | (98 | ) | (107 | ) | (0.08 | ) | |||||||||||||||
Restructuring and restructuring-related net charges (credits) | (10 | ) | (2 | ) | — | 15 | 15 | 12 | 0.01 | |||||||||||||||||||
Litigation-related net charges (credits) | — | — | — | 18 | 18 | 14 | 0.01 | |||||||||||||||||||||
Investment impairment charges | — | — | — | — | 3 | 3 | 0.00 | |||||||||||||||||||||
Adjusted net income | $ | 653 | $ | 849 | $ | 261 | $ | 613 | $ | 542 | $ | 485 | $ | 0.35 | ||||||||||||||
Three Months Ended September 30, 2017 | ||||||||||||||||||||||||||||
in millions, except per share data | Cost of Products Sold | SG&A Expenses | R&D Expenses | Operating Income (Loss) | Pre-Tax Income (Loss) | Net Income (Loss) | Impact per Share | |||||||||||||||||||||
GAAP net income (loss) | $ | 637 | $ | 800 | $ | 254 | $ | 377 | $ | 309 | $ | 283 | $ | 0.20 | ||||||||||||||
Non-GAAP adjustments: | ||||||||||||||||||||||||||||
Amortization expense | — | — | — | 139 | 139 | 122 | 0.09 | |||||||||||||||||||||
Intangible asset impairment charges | — | — | — | 3 | 3 | 3 | 0.00 | |||||||||||||||||||||
Acquisition-related net charges (credits) | (8 | ) | (14 | ) | (7 | ) | 25 | 25 | 14 | 0.01 | ||||||||||||||||||
Restructuring and restructuring-related net charges (credits) | (11 | ) | (3 | ) | — | 26 | 26 | 20 | 0.02 | |||||||||||||||||||
Litigation-related net charges (credits) | — | — | — | (12 | ) | (12 | ) | (10 | ) | (0.01 | ) | |||||||||||||||||
Adjusted net income | $ | 618 | $ | 783 | $ | 247 | $ | 558 | $ | 490 | $ | 432 | $ | 0.31 | ||||||||||||||
An explanation of the company's use of these non-GAAP financial measures is provided at the end of this document. |
Nine Months Ended September 30, 2018 | ||||||||||||||||||||||||||||
in millions, except per share data | Cost of Products Sold | SG&A Expenses | R&D Expenses | Operating Income (Loss) | Pre-Tax Income (Loss) | Net Income (Loss) | Impact per Share | |||||||||||||||||||||
GAAP net income (loss) | $ | 2,084 | $ | 2,616 | $ | 825 | $ | 1,187 | $ | 1,126 | $ | 1,285 | $ | 0.92 | ||||||||||||||
Non-GAAP adjustments: | ||||||||||||||||||||||||||||
Amortization expense | — | — | — | 437 | 437 | 380 | 0.27 | |||||||||||||||||||||
Intangible asset impairment charges | — | — | — | 35 | 35 | 31 | 0.02 | |||||||||||||||||||||
Acquisition-related net charges (credits) | (23 | ) | (52 | ) | (51 | ) | 114 | (68 | ) | (79 | ) | (0.06 | ) | |||||||||||||||
Restructuring and restructuring-related net charges (credits) | (33 | ) | (5 | ) | — | 58 | 58 | 47 | 0.03 | |||||||||||||||||||
Litigation-related net charges (credits) | — | — | — | 18 | 18 | 14 | 0.01 | |||||||||||||||||||||
Investment impairment charges | — | — | — | — | 7 | 7 | 0.01 | |||||||||||||||||||||
Discrete tax items | — | — | — | — | — | (177 | ) | (0.13 | ) | |||||||||||||||||||
Adjusted net income | $ | 2,027 | $ | 2,559 | $ | 775 | $ | 1,849 | $ | 1,613 | $ | 1,508 | $ | 1.08 | ||||||||||||||
Nine Months Ended September 30, 2017 | ||||||||||||||||||||||||||||
in millions, except per share data | Cost of Products Sold | SG&A Expenses | R&D Expenses | Operating Income (Loss) | Pre-Tax Income (Loss) | Net Income (Loss) | Impact per Share | |||||||||||||||||||||
GAAP net income (loss) | $ | 1,919 | $ | 2,408 | $ | 734 | $ | 967 | $ | 706 | $ | 719 | $ | 0.52 | ||||||||||||||
Non-GAAP adjustments: | ||||||||||||||||||||||||||||
Amortization expense | — | — | — | 424 | 424 | 365 | 0.26 | |||||||||||||||||||||
Intangible asset impairment charges | — | — | — | 3 | 3 | 3 | 0.00 | |||||||||||||||||||||
Acquisition-related net charges (credits) | (18 | ) | (35 | ) | (15 | ) | (10 | ) | (1 | ) | (20 | ) | (0.01 | ) | ||||||||||||||
Restructuring and restructuring-related net charges (credits) | (35 | ) | (9 | ) | — | 61 | 61 | 48 | 0.03 | |||||||||||||||||||
Litigation-related net charges (credits) | — | — | — | 196 | 196 | 123 | 0.09 | |||||||||||||||||||||
Investment impairment charges | — | — | — | — | 53 | 34 | 0.02 | |||||||||||||||||||||
Adjusted net income | $ | 1,866 | $ | 2,364 | $ | 719 | $ | 1,641 | $ | 1,442 | $ | 1,272 | $ | 0.91 | ||||||||||||||
An explanation of the company's use of these non-GAAP financial measures is provided at the end of this document. |
Q4 2018 Estimate | Full Year 2018 Estimate | Prior Full Year 2018 Estimate | ||||||||||||
(Low) | (High) | (Low) | (High) | (Low) | (High) | |||||||||
Estimated GAAP sales growth | 5 | % | 7 | % | 8 | % | 9 | % | 8 | % | 9 | % | ||
Less: Estimated impact of foreign currency fluctuations and sales from recent acquisitions | (1 | )% | 0 | % | 1 | % | 2 | % | 2 | % | 2 | % | ||
Estimated sales growth, organic* | 6 | % | 7 | % | 7 | % | 7 | % | 6 | % | 7 | % | ||
*Q4 2018 Estimate excludes contribution of approximately 120 basis points from NxThera, Claret and Augmenix. Full Year 2018 Estimate excludes contribution of approximately 80 basis points from Symetis SA, NxThera, Claret and Augmenix. Prior Full Year 2018 Estimate excluded contribution of approximately 40 basis points from Symetis. |
Q4 2018 Estimate | Full Year 2018 Estimate | Prior Full Year 2018 Estimate | |||||||||||||||||||
(Low) | (High) | (Low) | (High) | (Low) | (High) | ||||||||||||||||
GAAP results** | $ | 0.15 | $ | 0.17 | $ | 1.08 | $ | 1.10 | $ | 0.99 | $ | 1.03 | |||||||||
Estimated amortization expense | 0.10 | 0.10 | 0.36 | 0.36 | 0.36 | 0.36 | |||||||||||||||
Intangible asset impairment charges | — | — | 0.02 | 0.02 | 0.02 | 0.02 | |||||||||||||||
Estimated acquisition-related net charges (credits) | 0.03 | 0.03 | (0.03 | ) | (0.03 | ) | 0.05 | 0.05 | |||||||||||||
Estimated restructuring and restructuring-related net charges (credits) | 0.02 | 0.02 | 0.06 | 0.06 | 0.08 | 0.08 | |||||||||||||||
Litigation-related net charges (credits) | — | — | 0.01 | 0.01 | 0.00 | 0.00 | |||||||||||||||
Investment impairment charges | — | — | 0.01 | 0.01 | 0.00 | 0.00 | |||||||||||||||
Discrete tax items | — | — | (0.13 | ) | (0.13 | ) | (0.13 | ) | (0.13 | ) | |||||||||||
Adjusted results** | $ | 0.30 | $ | 0.32 | $ | 1.38 | $ | 1.40 | $ | 1.37 | $ | 1.41 | |||||||||
**Q4 Estimated GAAP and Adjusted results include $0.06 of reinvestment of the $0.06 Q2 2018 benefit from the finalization of the IRS Stipulation of Settled Issues. | |||||||||||||||||||||
Q3 2018 Estimate | ||||||
(Low) | (High) | |||||
GAAP results | $ | 0.21 | $ | 0.23 | ||
Estimated amortization expense | 0.08 | 0.08 | ||||
Estimated acquisition-related net charges (credits) | 0.02 | 0.02 | ||||
Estimated restructuring and restructuring-related net charges (credits) | 0.02 | 0.02 | ||||
Adjusted results | $ | 0.33 | $ | 0.35 | ||
• | Discrete tax items — These items represent adjustments of certain tax positions including those which a) are estimates as a result of the TCJA, enacted in December 2017, and, or b) were a benefit resulting from the finalization of the IRS Stipulation of Settled Issues consistent with the manner in which the tax reserves were originally booked. These adjustments are not indicative of expected ongoing operating results. We exclude the impact of this charge from management's assessment of operating performance and from our operating segments' measures of profit and loss used for making operating decisions and assessing performance. Accordingly, management excluded these amounts for the purposes of calculating these non-GAAP financial measures to facilitate an evaluation of our current operating performance and a comparison to our past operating performance. |
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Ticker: BSXEvents:
CIK: 885725
Form Type: 8-K Corporate News
Accession Number: 0000885725-18-000042
Submitted to the SEC: Wed Oct 24 2018 6:40:28 AM EST
Accepted by the SEC: Wed Oct 24 2018
Period: Wednesday, October 24, 2018
Industry: Surgical And Medical Instruments And Apparatus