On July 24, 2019 Boston Scientific Corporation (NYSE: BSX) reported its sales of $2.631 billion during the second quarter of 2019 (Press release, Boston Scientific, JUL 24, 2019, View Source [SID1234537721]). This represents growth of 5.6 percent on a reported basis, 8.0 percent on an operational1 basis and 6.3 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP earnings of $154 million or $0.11 per share (EPS), compared to GAAP earnings of $555 million or $0.40 per share a year ago, and achieved adjusted earnings per share of $0.39 for the period, compared to $0.41 a year ago.
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"The consistent execution of our global teams continues to help us grow the majority of our businesses faster than the market while delivering adjusted EPS at the high end of guidance," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "As highlighted at our Investor Day last month, we are excited for our long-term outlook and our robust pipeline of unique innovations to address unmet patient needs."
Second quarter financial results and recent developments:
Reported second quarter sales of $2.631 billion, representing an increase of 5.6 percent on a reported basis, compared to the company’s guidance range of 5 to 7 percent; 8.0 percent on an operational basis; and 6.3 percent on an organic basis, compared to the company’s guidance range of 6 to 7 percent, all compared to the prior year period.
Reported GAAP earnings of $0.11 per share compared to the company’s guidance range of $0.23 to $0.25 per share, due to acquisition-related charges in the quarter primarily associated with the proposed acquisition of BTG plc. Achieved adjusted earnings per share of $0.39 compared to the guidance range of $0.37 to $0.39 per share.
Achieved second quarter revenue growth in all segments, compared to the prior year period:
MedSurg: 9.0 percent reported, 10.9 percent operational and 7.4 percent organic
Rhythm and Neuro: 1.4 percent reported, 3.3 percent operational and 2.8 percent organic
Cardiovascular: 6.3 percent reported, 9.2 percent operational and 8.1 percent organic
Reported second quarter revenue growth in all regions, compared to the prior year period:
U.S.: 6.0 percent reported and operational
EMEA (Europe, Middle East and Africa): 2.3 percent reported and 8.3 percent operational
APAC (Asia-Pacific): 8.9 percent reported and 13.2 percent operational
Emerging Markets3: 12.3 percent reported and 20.0 percent operational
Initiated randomized study assessing the safety and effectiveness of the ACURATE neo2 Aortic Valve System in intermediate, high and extreme-risk patients indicated for transcatheter aortic valve replacement (TAVR). The results of this trial are expected to serve as the basis of the company’s premarket approval submission to the U.S. Food and Drug Administration (FDA).
Began the global OPTION trial, a study of patients with non-valvular atrial fibrillation who undergo a cardiac ablation procedure, to compare the safety and effectiveness of the next-generation WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device to first-line oral anticoagulants for stroke risk reduction.
Announced and closed the acquisition of Vertiflex, Inc., a privately-held company that developed and commercialized the Superion Indirect Decompression System, a minimally-invasive device used to improve physical function and reduce pain in patients with lumbar spinal stenosis.
Presented two-year results from the INTREPID randomized controlled trial at the 18th Meeting of the World Society for Stereotactic and Functional Neurosurgery. Data demonstrated the safety and effectiveness of the Vercise Deep Brain Stimulation (DBS) System for the treatment of patients with Parkinson’s disease symptoms.
Presented real world data at the International Neuromodulation Society World Congress from 420 chronic pain patients using the Spectra WaveWriter Spinal Cord Stimulation (SCS) System. Results showed two-thirds of patients reported a pain score of two or less at last follow-up, as measured on the zero to 10 numeric rating scale.
Announced acute results from the UNTOUCHED study of the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System for primary prevention of sudden cardiac death specifically in patients with a left ventricular ejection fraction (LVEF) ≤35 percent, the most common population to be indicated for ICD therapy.4,5 Data presented at the Heart Rhythm Society’s 40th Annual Scientific Sessions demonstrated S-ICD therapy had a complication-free rate of 95.8 percent at 30 days post-procedure and high conversion efficacy (99.2 percent) of induced ventricular fibrillation, rates comparable to those seen in previous S-ICD and transvenous implantable cardioverter-defibrillator (TV-ICD) studies.
Commenced controlled launch in the U.S. and Europe of the LOTUS Edge Aortic Valve System, a minimally invasive TAVR technology for patients with severe aortic stenosis considered to be at high risk for surgical valve replacement via open heart surgery.
Received approval from the United Kingdom’s National Health Service for inclusion of the SpaceOAR Hydrogel in its Innovation and Technology Payment program, expanding treatment access to men undergoing radiotherapy for prostate cancer.
Received FDA clearance for the Tactra Next-Generation Malleable Penile Prosthesis, the first and only penile implant for men with erectile dysfunction to include a nitinol core to optimize rigidity, durability and concealment.
Received FDA approval and launched in the U.S. the VICI VENOUS STENT System for the treatment of iliofemoral venous obstructive disease.
Announced the divestiture of the existing Boston Scientific drug-eluting and bland embolic microsphere portfolio to Varian Medical Systems for an upfront cash payment of $90 million, subject to the successful completion of the company’s proposed acquisition of BTG plc.
1. Operational revenue growth excludes the impact of foreign currency fluctuations.
2. Organic revenue growth excludes the impact of foreign currency fluctuations and sales from the recent acquisitions of NxThera, Inc. (NxThera), Claret Medical, Inc. (Claret), Augmenix, Inc. (Augmenix) and Vertiflex, Inc. (Vertiflex), each with no prior year comparable sales.
3. We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities. Periodically, we assess our list of Emerging Markets; effective January 1, 2019, we updated our list of Emerging Market countries. We have revised prior year amounts to the current year’s presentation (as denoted with † throughout). The revision had an immaterial impact on prior year Emerging Markets sales.
4. Friedman, DJ, Parzynski, CS, Varosy, PD, et al., Trends and In-Hospital Outcomes Associated With Adoption of the Subcutaneous Implantable Cardioverter Defibrillator in the United States. JAMA Cardiol, 2016. 1(8): p. 900-911.
5. Haugaa, KH, Tilz, R, Boveda, S, et al., Implantable cardioverter defibrillator use for primary prevention in ischaemic and non-ischaemic heart disease-indications in the post-DANISH trial era: results of the European Heart Rhythm Association survey. Europace, 2017. 19(4): p. 660-664.
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 aforementioned acquisitions
are not prepared in accordance with U.S. GAAP.
Guidance for Full Year and Third Quarter 2019
The company estimates revenue growth for the full year 2019, versus the prior year period, to be in a range of approximately 7 to 8 percent on a reported basis (consistent with prior guidance), and a growth range of approximately 7 to 8 percent on an organic basis (consistent with prior guidance). Full year organic guidance excludes the impact of foreign currency fluctuations and contribution of approximately 140 basis points from the acquisitions of NxThera, Claret, Augmenix and Vertiflex, each with no prior period related net sales. The company now estimates income on a GAAP basis in a range of $0.94 to $0.98 per share (compared to prior guidance of $1.09 to $1.13 per share) and estimates adjusted earnings, excluding certain charges (credits), in a range of $1.54 to $1.58 per share (consistent with prior guidance).
The company estimates revenue growth for the third quarter of 2019, versus the prior year period, to be in a range of approximately 8 to 10 percent on a reported basis and a growth range of approximately 7.5 to 9 percent on an organic basis. Third quarter organic guidance excludes the impact of foreign currency fluctuations and contribution of approximately 180 basis points from the acquisitions of Claret, Augmenix and Vertiflex, each with no prior period related net sales. The company estimates earnings on a GAAP basis in a range of $0.23 to $0.25 per share and adjusted earnings, excluding certain charges (credits), in a range of $0.37 to $0.39 per share.
Conference Call Information
Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. EDT. The company will webcast the call to interested parties through its website: www.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.