On February 1, 2023 Boston Scientific Corporation reported net sales of $3.242 billion during the fourth quarter of 2022, growing 3.7 percent on a reported basis, 8.7 percent on an operational1 basis and 7.1 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, FEB 1, 2023, View Source [SID1234633022]). Included within organic results is a negative approximately 200 basis point impact associated with unplanned reserves established for Italian government payback provisions3. The company reported GAAP net income available to common stockholders of $126 million or $0.09 per share (EPS), compared to $80 million or $0.06 per share a year ago and achieved adjusted4 EPS of $0.45 for the period, which includes an approximate $0.04 negative impact of the Italian payback, compared to $0.45 a year ago.
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For the full year 2022, the company generated net sales of $12.682 billion, growing 6.7 percent on a reported basis, 11.1 percent on an operational1 basis and 8.7 percent on an organic2 basis, including a negative 50 basis point impact associated with the Italian government payback provisions, all compared to the prior year period. The company reported GAAP net income available to common stockholders of $642 million or $0.45 per share, compared to $985 million or $0.69 per share a year ago, and delivered full year adjusted4 EPS of $1.71, including the approximate $0.04 negative impact of the Italian payback, compared to $1.63 a year ago.
"Our global team continues living our mission to transform lives, and I’m proud of the results we achieved in the fourth quarter and throughout 2022," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "In the year ahead we remain committed to our goals of delivering new, meaningful innovations to benefit patients globally while continuing to deliver differentiated financial performance."
Fourth quarter financial results and recent developments:
Reported net sales of $3.242 billion, representing an increase of 3.7 percent on a reported basis, compared to the company’s guidance range of 2 to 4 percent; 8.7 percent on an operational basis; and 7.1 percent on an organic basis, compared to the company’s guidance range of 7 to 9 percent, all compared to the prior year period.
Reported GAAP net income available to common stockholders of $0.09 per share, compared to the company’s guidance range of $0.23 to $0.28 per share, and achieved adjusted EPS of $0.45 per share, compared to the guidance range of $0.45 to $0.48 per share.
Achieved the following net sales growth in each reportable segment5, compared to the prior year period:
MedSurg: 4.4 percent reported, 8.5 percent operational and organic
Cardiovascular: 6.4 percent reported, 12.1 percent operational and 9.4 percent organic
Achieved the following net sales growth/(declines) in each region, compared to the prior year period:
U.S.: 10.5 percent reported and operational
EMEA (Europe, Middle East and Africa): (0.8) percent reported and 10.8 percent operational
APAC (Asia-Pacific): (4.1) percent reported and 9.8 percent operational
LACA (Latin America and Canada): 14.6 percent reported and 17.7 percent operational
Emerging Markets7: 11.6 percent reported and 23.3 percent operational
Received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the AGENT Drug Coated Balloon (DCB) in Japan to treat patients with in-stent restenosis (ISR) and coronary small vessel disease (SVD), with launch anticipated in the first half of this year.
Completed enrollment in the CHAMPION-AF clinical trial, a randomized, head-to-head study with 3,000 patients evaluating the safety and efficacy of the WATCHMAN FLX Left Atrial Appendage Closure Device compared to non-vitamin K antagonist oral anticoagulants for stroke prevention in a broad population of patients with non-valvular atrial fibrillation.
Completed enrollment in the SOLIS randomized clinical trial to assess WaveWriter Spinal Cord Stimulator Systems (SCS) for the treatment of patients with chronic low back and/or leg pain who have not undergone spinal surgery (NSBP, Non-Surgical Back Pain/VB, Virgin Back). The study met its primary endpoint; SCS demonstrated superior outcomes compared with Conventional Medical Management at three-month follow-up.
Began enrollment in the ACURATE Prime XL Nested Registry, which is designed to assess outcomes from patients receiving the larger ACURATE Prime Aortic Valve XL within the ACURATE IDE clinical study in the U.S. Also announced, at PCR London Valves, late-breaking data from the European ACURATE neo2 Post Market Clinical Follow-up study supporting the clinical procedural success and safety of the ACURATE neo2 Aortic Valve System to treat patients with severe aortic stenosis, including a high procedural success rate and low rates of mortality and paravalvular leak.
Presented positive data from the ELEGANCE registry during a late-breaking presentation at the 2022 Vascular InterVentional Advances (VIVA) conference, which highlighted that the study is currently exceeding its goal to increase the representation of women and underrepresented minorities in clinical trials for drug-eluting peripheral therapies. Patients enrolled in the registry will be followed for up to five years, allowing for the evaluation of long-term outcomes and the gathering of critical clinical insights into underrepresented patient populations.
Announced agreement to acquire Apollo Endosurgery, Inc. (Nasdaq: APEN) , subject to customary closing conditions, to expand the Boston Scientific endoluminal surgery portfolio and enable a measured entry into the endobariatric market.
Announced strategic investment to acquire majority stake in Acotec Scientific Holdings Limited, a Chinese medical technology company that offers solutions designed for a variety of interventional procedures, subject to customary closing conditions.