Boston Scientific Reports Record $14.24 Billion in Annual Revenue with Dual Growth Drivers: FARAPULSE FDA Approval and Strong Cardiovascular Performance

Feb 01, 2024 16:53 CST Updated 16:53

Boston Scientific

Medical Device Manufacturer

Source: Heart Future; Editor: Liu Xinyi

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Heart Future

On January 31, 2024, Boston Scientific (NYSE: BSX) announced its fiscal year 2023Annual PerformanceAndFourth Quarter Performance, while announcing the company'sFARAPULSE Pulse Field Ablation (PFA) System Receives FDA Approval。

2023Annual net sales were $14.24 billion (approximately 101.1 billion RMB), an increase of 12.3% year-over-year; net sales in the fourth quarter were $3.73 billion, an increase of 14.9% year-over-year;

2023Annual net profit of $504 million (approximately 3.6 billion RMB)，Increased by 300% year-over-year；Net profit in the fourth quarter was $1.57 billion，An increase of 144.5% year-over-year；

The story goes that as early as January 2021, Boston Scientific's (hereinafter referred to as "Boston Scientific") PFA system FARAPULSE obtained CE certification.The FirstObtainCE CertificationPFA System(For the system introduction, please see the end of the article). Since then, Boston Scientific has been vigorously promoting the system in the European market. Globally, more than 40,000 patients have already used it, laying a solid market foundation.

But what Boston Scientific did not expect was that, just as it was waiting for the FDA's initial approval, the MinotaurMedtronicStick one's oar in,With a speed that is too fast to cover one's ears.In just one monthOne after anotherCE Certification (November 2023) and FDA Approval (December 2023), Relying on PulseSelect, it succeeded.The FirstPFA System ObtainedFDA ApprovalThe Company。

Analysts had previously estimated that the FARAPULSE system would be approved in early 2024. Taking advantage of the earnings report release, Boston Scientific Corporation eagerly announced this good news.

However, in the field of transcatheter aortic valve replacement (TAVR), Boston Scientific Corporation still hit a snag. The company predictedAcurate Prime Aortic ValveIn 2024NoObtained FDA approval。

The company, after reviewing the interim analysis of the device's data in the U.S., is now waiting.Around the end of 2024The one-year data of the trial must come out before deciding how to complete the regulatory approval process.

Boston Scientific had hoped to bring Acurate to the TAVR market this year to compete with Edwards Lifesciences and Medtronic, but ultimately fell short of its goal.

# Annual Events

Announcement of the Launch of New Pulsed Field Ablation Clinical TrialsAVANT GUARD, which is currentlyThe Only OneStudy on PFA Therapy asPersistent Atrial FibrillationExperiment on the Safety and Efficacy of First-Line Treatment. The experiment compares the efficacy of the company's FARAPULSE™ system and antiarrhythmic drugs (AAD) in treating persistent atrial fibrillation. (Review:Boston Scientific Strikes Back at Medtronic: New Pulsed Field Ablation Experiment Launched!）
Results of the MANIFEST-17K large observational study were announced at the American Heart Association Scientific Sessions (AHASS). The study utilized a retrospective approach to analyze outcomes from the treatment of arrhythmias using the FARAPULSE™ PFA System. The data shows,The overall incidence of major adverse events was less than 1%. Additionally, no cases of atrial-esophageal fistula/esophageal dysfunction, pulmonary vein stenosis, or persistent phrenic nerve injury were reported.。
LAAOS-4 Global Research TrialStart EnrollmentThe study focuses on the efficacy of WATCHMAN FLX™ and WATCHMAN FLX Pro, two left atrial appendage closure devices combined with oral anticoagulants, for atrial fibrillation patients at the highest risk of stroke.
TENACIO™ PumpObtained FDA ApprovalThis is the new pump component of the AMS 700™ Inflatable Penile Prosthesis, a treatment option for patients with erectile dysfunction.
Completion of the acquisition focused on diagnostic and treatment solutions for spine-related lower back painRelievant Medsystems(Advance payment of 850 million US dollars, review:$6.2 Billion! Boston Scientific Completes Acquisition）；
Start acquiring manufacturers of devices for treating urinary and bowel dysfunctionAxonics(Total price of 3.7 billion USD, looking back:$26.2 Billion Mega-Acquisition! Boston Scientific Enters Sacral Neuromodulation Market）。

# Earnings Highlights

Annual Report 2023Net sales were $14.24 billion (approximately 101.1 billion RMB), representing a year-over-year increase of 12.3%.; Net sales in the fourth quarter were $3.73 billion, a year-over-year increase of 14.9%;

Annual Report 2023Net profit was US$504 million (approximately RMB 3.6 billion), a year-on-year increase of 300%.; Net profit in the fourth quarter was US$1.57 billion, increasing by 144.5% year-on-year;

By department,Boston Scientific's business is divided into two major segments: Medical Surgical and Cardiovascular, with both segments experiencing similar growth rates.: The former achieved 10% organic growth for the full year, with total net sales of $5.422 billion;The latter achieved organic growth of 13% for the full year, with total net sales reaching $8.819 billion.For the performance of the two major departments' subfields, please see below;

By region,Boston Scientific has the largest business in the U.S. ($8.43 billion, 10.4%), followed by Europe, the Middle East and Africa (2.86 billion, 13.1%) and the Asia-Pacific region (2.4 billion, 13.4%). The region with the smallest business volume is Latin America and Canada (560 million, 19.3%).

# Department Performance

Boston Scientific's medical surgical business can be subdivided intoEndoscope、UrinaryAndNeuromodulation。

By growth rateEndoscopy (11%) = Urology (11%) > Neuromodulation (5%)

By Net SalesEndoscopy (2.48 billion) > Urology (1.96 billion) > Neuromodulation (980 million)

Boston Scientific's cardiovascular business can be further divided into cardiology.（Interventional Cardiology、Watchman、Heart Rhythm Management、Electrophysiology) andPeripheral Vascular Intervention。

By growth rate：Electrophysiology (33%) > Watchman (25%)>Peripheral Vascular Interventions (11%) >Cardiac Interventional Treatments (10%) >Heart Rate Management (6%)

By Net Sales：Interventional Cardiology (2.42 billion) > Heart Rate Management (2.218 billion)>Peripheral Vascular Intervention (2.11 billion) >Watchman (1.27 billion) >Electrophysiology (800 million)

Electrophysiology Growth33%Watchman Growth25%These two exaggerated figures are sufficient enough to explain why several major device manufacturers entered the PFA and left atrial appendage closure market last year.

The financial report shows that in the fourth quarter, global net sales of electrophysiology increased by 43.9% year-over-year due to the launch of POLARx™, continued growth in Access Solutions technology, and improved supply of the FARAPULSE™ console.

Watchman Left Atrial Appendage Closure Device Achieves Record Sales and Utilization in All Major Markets in Q4. In addition, because the WATCHMAN FLX Pro approved by the FDA this year is even moreDriving 23% growth in the U.S. market。

# About FARAPULSE

The FARAPULSE system is used forIsolated Pulmonary Vein, applicable for the treatment of drug-resistant, easily recurrent, symptomatic, paroxysmal atrial fibrillation.

The FARAPULSE ablation system consists of three components: the FARAWAVE ablation catheter, the FARADRIVE sheath, and the FARASTAR generator.

FARAWAVE: Ablation catheter with a diameter of 12Fr, itsThe distal end adopts a uniqueSplineDesign，This structure allows the ablation electrode to better adapt to the different shapes of the pulmonary veins, achieve stable contact, and enhance the flexibility of clinical operations.

SplineThere are a total of 5 "petals," each upper petal is equipped with 4 electrodes. The slider button on the handle can control the shape of the splines. When the 5 "petals" are fully opened, they present a flat petal shape, and when partially expanded, they appear as a three-dimensional basket shape. FARAWAVE comes in two specifications.The biggest difference lies in the maximum diameter when the spline is fully expanded., respectively31mmAnd35mm。

FARADRIVE: A 13Fr-diameter sheath can better navigate FARAWAVE to the ostia of each pulmonary vein.

FARASTAR: Utilizes bipolar and biphasic waveforms, along with proprietary pulse technology. Its interface operation is very simple, allowing pulmonary vein vestibule isolation to be completed with just three buttons.

# Company Profile

Boston Scientific (NYSE: BSX) was founded in 1979, with its headquarters in Natick, Massachusetts, USA. It is a global leading medical technology company. In 1997, Boston Scientific entered China, establishing branch offices and research centers in Beijing, Shanghai, and Guangzhou. The company's headquarters in China is located in Shanghai. In May 1992, Boston Scientific was successfully listed on the New York Stock Exchange.

The company offers more than 17,000 products that improve the quality of life, covering areas such as cardiac intervention, structural heart disease, peripheral and tumor intervention, cardiac rhythm management and electrophysiology, endoscopic intervention, respiratory intervention, urology, otorhinolaryngology, and neuromodulation.

From 2004 to 2020, Boston Scientific was consistently ranked among the Fortune 500 companies; from 2016 to 2021, Boston Scientific was named one of the World's Most Admired Companies by Fortune magazine for six consecutive years. From 2017 to 2021, it was listed among the "Top 100 Global Innovators" by Clarivate Analytics (formerly Thomson Reuters) for five consecutive years. Since 2013, Boston Scientific has had nine products or technologies win or be nominated for the Prix Galien Award, including three products nominated for the 2022 Prix Galien "Best Medical Technology" Award, making it the company with the most nominations in this category that year.

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