On October 28, 2020 Boston Scientific Corporation (NYSE: BSX) reported that sales of $2.659 billion during the third quarter of 2020 (Press release, Boston Scientific, OCT 28, 2020, View Source [SID1234569201]). This represents a decline of (1.8) percent on a reported basis, (2.5) percent on an operational1 basis and (5.7) percent on an organic2 basis, all compared to the prior year period. The company reported a GAAP net loss available to common stockholders of $(169) million or $(0.12) per share (EPS), compared to GAAP net income of $126 million or $0.09 per share a year ago, and achieved adjusted EPS of $0.37 for the period, compared to $0.39 a year ago.

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"We have a robust cadence of new product launches across our portfolio, and in the third quarter, we delivered strong sequential improvement in our financial performance," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "I am grateful to our global team for their winning spirit and remain confident that our pipeline of products and services positions us well to continue delivering growth at the high end of our peer group."

Third quarter financial results and recent developments:

Included within organic sales results is a negative 230 basis point impact associated with the conversion of U.S. WATCHMAN customers to a consignment inventory model and transition to the next-generation WATCHMAN FLX.

Reported a GAAP net loss available to common stockholders of $(0.12) per share and achieved adjusted EPS of $0.37. The company had not provided third quarter sales and EPS guidance due to ongoing uncertainty associated with the scope and duration of the COVID-19 pandemic.
Included in adjusted EPS is a $(0.04) impact from WATCHMAN discussed above, offset by a $0.06 tax benefit3.

Third quarter sales declined in each of our reportable segments5, compared to the prior year period:
MedSurg: (2.3) percent reported, (3.0) percent operational and (1.9) percent organic
Rhythm and Neuro: (3.0) percent reported, (3.9) percent operational and organic
Cardiovascular: (5.3) percent reported, (5.9) percent operational and (10.4) percent organic

Generated third quarter regional6 sales growth/(declines), compared to the prior year period:
U.S.: (4.2) percent reported and operational
EMEA (Europe, Middle East and Africa): 0.8 percent reported and (2.9) percent operational
APAC (Asia-Pacific): (2.6) percent reported and (4.1) percent operational
Emerging Markets4: (10.3) percent reported and (7.1) percent operational

Received FDA approval for the AVVIGO Guidance System, a tablet platform designed to provide ease of use and accuracy when utilizing fractional flow reserve wires during percutaneous coronary intervention procedures.

Received FDA approval for the high bleeding risk indication for the SYNERGY and SYNERGY XD Bioabsorbable Polymer Drug-Eluting Stent Systems (excluding the recently launched 48 mm stent size).

Obtained CE Mark and initiated a limited market release in Europe of the WaveWriter Alpha portfolio of spinal cord stimulator (SCS) systems, consisting of four full-body MRI conditional, Bluetooth-enabled devices to provide personalized treatment for chronic intractable pain.7

Obtained CE Mark and initiated a limited market release in Europe of the fourth generation Vercise Genus Deep Brain Stimulation (DBS) System to treat the symptoms of Parkinson’s disease, essential tremor and dystonia by delivering precisely targeted electrical stimulation, with full-body MRI conditional and Bluetooth capabilities to better meet individuals’ specific needs.8

Commenced the full global launch of the SpyGlass Discover Digital Catheter, the first single-use scope to enable physicians to take a single-stage approach to diagnostic and therapeutic procedures in the pancreaticobiliary system, including treating patients with bile duct stones.

Initiated the U.S. launch of the SpaceOAR Vue Hydrogel, a next-generation hydrogel spacer that is designed to reduce the side effects of prostate radiation therapy, while providing clinicians with the added ability to view the spacer using computerized tomography (CT) scans instead of magnetic resonance imaging (MRI).

Initiated the European launch of the ACURATE neo2 Aortic Valve System, a new transcatheter aortic valve implantation platform designed to minimize paravalvular leaking and facilitate highly accurate positioning, for patients with aortic stenosis.

Received a New Technology Add-on Payment (NTAP) designation from the U.S. Centers for Medicare and Medicaid Services for the Eluvia Drug-Eluting Vascular Stent System, developed for the treatment of PAD, providing eligible hospitals with incremental reimbursement for the Eluvia stent system. The NTAP designation is awarded to new medical devices determined to substantially improve the diagnosis or treatment of Medicare beneficiaries and went into effect on October 1, 2020.

Announced an expanded investment and exclusive acquisition option agreement with Farapulse, Inc., a privately-held company developing a pulsed field ablation system for the treatment of atrial fibrillation (AFib) and other cardiac arrhythmias via the creation of a therapeutic electric field.

1. Operational revenue growth excludes the impact of foreign currency fluctuations.

2. Organic revenue growth excludes the impact of foreign currency fluctuations and net sales associated with our Q3 2019 acquisition of BTG plc (BTG) for the period prior to mid-August, for which there were no prior period net sales. Organic revenue growth also excludes the impact of the divestiture of our global embolic microspheres portfolio, a transaction entered into in connection with obtaining the antitrust clearances required to complete the BTG transaction, also for the period prior to mid-August, as well as prior period net sales associated with our intrauterine health franchise, which we divested in Q2 2020.

3. We recorded a $0.06 non-cash tax benefit due to the resolution of the IRS examination of our 2014 through 2016 tax years.

4. 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.

5. We have three historical reportable segments comprised of Medical Surgical (MedSurg), Rhythm and Neuro, and Cardiovascular, which represent an aggregation of our operating segments that generate revenues from the sale of medical devices (Medical Devices). As part of our acquisition of BTG on August 19, 2019, we acquired an Interventional Medicine business, which is now included in our Peripheral Interventions operating segment’s revenues from the date of acquisition. We have revised amounts for the third quarter of 2019 to conform to the current year presentation..

6. As part of our acquisition of BTG on August 19, 2019, we acquired a specialty pharmaceuticals business (Specialty Pharmaceuticals). Subsequent to acquisition, Specialty Pharmaceuticals is now a stand-alone operating segment presented alongside our Medical Device reportable segments. We have revised amounts for the third quarter of 2019 to conform to the current year presentation. Specialty Pharmaceuticals net sales are substantially U.S. based. Our chief operating decision maker (CODM) reviews financial information of our globally managed Specialty Pharmaceuticals operating segment at the worldwide level without further disaggregation into regional results. As such, Specialty Pharmaceuticals net sales are presented globally, and our Medical Devices reportable segments regional net sales results do not include Specialty Pharmaceuticals.

7. The WaveWriter Alpha and WaveWriter Alpha Prime Spinal Cord Stimulator Systems provide safe access to full-body 1.5T MRI scans when used with specific components and exposed to the MRI environment under the defined conditions in the ImageReady MRI Full Body Guidelines for WaveWriter Alpha and WaveWriter Alpha Prime Spinal Cord Stimulator Systems.

8. 1.5 Tesla MRI conditional when all conditions of use are met.

*In the third quarter of 2019, we presented Interventional Medicine and Specialty Pharmaceuticals together as "BTG Acquisition" and outside of our operating and reportable segments net sales. Following the integration of BTG, we now include Interventional Medicine business within our Peripheral Interventions operating segment, within the Cardiovascular reportable segment. We present Specialty Pharmaceuticals business as a standalone operating segment alongside our reportable segments. We have revised amounts for the third quarter of 2019 to conform to the current year presentation.

*In the third quarter of 2019, we presented Interventional Medicine and Specialty Pharmaceuticals together as "BTG Acquisition" and outside of our operating and reportable segments net sales. Following the integration of BTG, we now include Interventional Medicine business within our Peripheral Interventions operating segment, within the Cardiovascular reportable segment. We present Specialty Pharmaceuticals business as a standalone operating segment alongside our reportable segments. We have revised amounts for the third quarter of 2019 to conform to the current year presentation.

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 / divestitures are not prepared in accordance with U.S. GAAP.

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.