Boston Scientific Corporation (NYSE: BSX) generated net sales of $2.708 billion during the fourth quarter of 2020. This represents a decline of (6.8) percent on a reported basis, (8.3) percent on an operational¹ basis and (8.0) percent on an organic² basis, all compared to the prior year period. Included within organic results is a negative 370 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™ Left Atrial Appendage Closure (LAAC) Device. The company reported GAAP net income available to common stockholders of $138 million or $0.10 per share (EPS), compared to GAAP net income of $3.996 billion or $2.83 per share a year ago and achieved adjusted EPS of $0.23 for the period, compared to $0.46 a year ago. In the fourth quarter of 2019, reported GAAP net income included a net income tax benefit of $4.102 billion or $2.90 per share related to an intra-entity asset transfer of intellectual property.

For the full year 2020, the company generated net sales of $9.913 billion. This represents a decline of (7.7) percent on a reported basis, (7.8) percent on an operational¹ basis and (11.3) percent on an organic² basis, all compared to the prior year period. Included within organic results is a negative 170 basis point impact associated with the WATCHMAN™ conversion. The company reported a GAAP net loss available to common stockholders of $(173) million or $(0.12) per share, compared to GAAP net income of $4.700 billion or $3.33 per share a year ago, and delivered full year adjusted EPS of $0.96, compared to $1.58 a year ago. Full year 2019 GAAP EPS included a net income tax benefit of $2.91 per share related to the intra-entity asset transfer of intellectual property discussed above.

"As we look to 2021 and beyond, we are well-positioned given the strength of our global team and our diversified portfolio," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "I'm excited about our outlook for growth—from our category leadership positions to our innovative pipeline and commercial execution—and I am incredibly proud of how Boston Scientific delivered on our mission to transform lives amid the challenges of 2020."

Fourth quarter financial results and recent developments:

• Reported GAAP net income available to common stockholders of $0.10 per share and adjusted EPS of $0.23 per share. Included in adjusted EPS is:
  • a ($0.06) impact associated with the WATCHMAN™ conversion mentioned above, which is now substantially complete, and
  • an ($0.07) impact related to the voluntary recall of the LOTUS Edge™ Aortic Valve System and discontinuation of the LOTUS platform

• Generated the following sales growth/(declines) in each reportable segment⁴, compared to the prior year period:
  • MedSurg: 1.5 percent reported, 0.1 percent operational and 1.1 percent organic
  • Rhythm and Neuro: (6.1) percent reported, (7.7) percent operational and organic
  • Cardiovascular: (12.0) percent reported, (13.5) percent operational and organic

• Generated the following regional⁵ sales declines, compared to the prior year period:
  • U.S.: (9.2) percent reported and operational
  • EMEA (Europe, Middle East and Africa): (1.1) percent reported and (5.9) percent operational
  • APAC (Asia-Pacific): (1.1) percent reported and (5.6) percent operational
  • Emerging Markets³: (9.9) percent reported and (8.9) percent operational

• Received U.S. Food and Drug Administration (FDA) approval for Vercise Genus™ family of Deep Brain Stimulation Systems, approved for MR conditional use in a magnetic resonance imaging (MRI) environment.

• Received FDA approval for WaveWriter Alpha™ portfolio of Spinal Cord Stimulator Systems, offering expanded personalization based on patient needs to treat multiple areas of chronic pain.

• Received FDA Breakthrough Device designation for the AGENT™ Drug-Coated Balloon (DCB),⁶ which is designed for percutaneous transluminal coronary angioplasty to treat coronary artery disease. Breakthrough Device designation provides patients more timely access to novel devices that may provide a substantial improvement over existing therapies.

• Received FDA approval for the SYNERGY MEGATRON™ Bioabsorbable Polymer Stent⁷, the only stent platform that is purpose built for use in large proximal vessels with the ability to expand to 6.0 mm in diameter.

• Received FDA approval for the Ranger™ Drug-Coated Balloon, developed for the treatment of patients with peripheral artery disease in the superficial femoral artery and proximal popliteal artery. Positive 24-month data from the COMPARE trial was also presented at the Leipzig Interventional Course (LINC) congress, demonstrating non-inferiority of the low-dose paclitaxel-coated Ranger DCB (2.0 µg/mm2) compared to the higher dose IN.PACT™ DCB (Medtronic) balloon (3.5 µg/mm2).

• Received approval for the Eluvia™ Drug-Eluting Vascular Stent System from China's Center for Medical Device Evaluation and initiated a full launch in the region.

• Received FDA approval for the ORISE™ ProKnife, a cutting tool designed for endoluminal surgeries and organ-sparing alternatives to surgery for cancer removal and mortality disorders of the gastrointestinal tract.

• Received Japanese Pharmaceuticals and Medical Devices Agency approval and Japanese National Health Insurance reimbursement approval for the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device, with plans to launch later this year, and surpassed 150,000 cumulative WATCHMAN implants worldwide.

• Announced the initiation of CHAMPION-AF—a randomized head-to-head trial to study the safety and efficacy of the next-generation WATCHMAN FLX device vs. non-vitamin K antagonist oral anticoagulants outcomes across a broad spectrum of patients with non-valvular atrial fibrillation, to evaluate the technology as a potential first-line therapy.

• Received Class I designation for the EMBLEM™ Subcutaneous Implantable Defibrillator System in recently updated American Heart Association and American College of Cardiology guidelines on treating patients with hypertrophic cardiomyopathy.

• Received approval from the FDA to begin the early feasibility study in the U.S. for the Millipede Transcatheter Annuloplasty Ring System⁸, which will assess the safety and feasibility of the system in patients with functional mitral regurgitation.

• Announced a definitive agreement to acquire Preventice Solutions, Inc., a privately-held company which offers a full portfolio of mobile cardiac health solutions and services, for a purchase price of $925 million, with up to an additional $300 million in a potential commercial milestone payment. Boston Scientific is currently an investor in Preventice and holds an equity stake of approximately 22 percent, which is expected to result in a net payment of approximately $720 million upon closing and a milestone payment of up to approximately $230 million.

• Signed definitive agreement to divest BTG Specialty Pharmaceuticals business to Stark International Lux S.A.R.L. and SERB SAS, affiliates of SERB, for $800 million in cash.