$7.5 Billion

KEY EXECUTIVES:
Michael Mahoney, President and CEO
Keith D. Dawkins, M.D., Exec. VP and Global Chief Medical Officer
Daniel J. Brennan, Exec. VP and CFO
Kevin J. Ballinger, Sr. VP and President, Interventional Cardiology
Maulik Nanavaty, Sr. VP and President, Neuromodulation
Joseph M. Fitzgerald, Exec. VP and President, Rhythm Management
Michael P. Phalin, Exec. VP and President, MedSurg
Jeffrey B. Mirviss, Sr. VP and President, Peripheral Interventions
Karen Prange, Sr. VP and President, Urology and Pelvic Health
David A. Pierce, Sr. VP and President, Endoscopy

NUMBER OF EMPLOYEES: 25,000

GLOBAL HEADQUARTERS: Marlborough, Mass.

Sometimes the point of a medical device business’s operations can be lost amid the muddle of fiscal facts and figures—I’m talking, of course, about the patients actually receiving the devices. According to Boston Scientific Corp. (or, at least, according to a rounded average based on company sales and estimated usage patterns), the company has helped more than 22 million patients in 2015, a point President and CEO Michael Mahoney takes care to mention in the opening paragraph of his letter within the annual report. And while the remaining 99 percent of a company report dictates where, how, and why money was made, it’s nice to see at least a small nod to the patients whose lives have been improved.

Naturally, a company cannot make lifesaving products without the cash to back them up, and fiscal year 2015 (ended Dec. 31) proved to be successful for Boston Scientific in that regard. The company continued to see an upward trend in revenue, with full-year sales of $7.47 billion, an 8 percent operational revenue growth, 5 percent organic revenue growth, and 1 percent revenue growth from 2014. Adjusted earnings per share in 2015 were 93 cents, compared to 84 cents in 2014, representing an 11 percent increase year over year. The company reported a GAAP loss of 18 cents per share, as compared to both 2013 and 2014’s 9 cents. Boston Scientific continues to invest in new opportunities in emerging markets—where operational revenue has grown by 13 percent—especially highlighted in China, where the company experienced 20 percent growth. In addition, Boston Scientific funneled $876 million (about 11.7 percent of total sales) into research and development.

“2015 was an excellent year for Boston Scientific as we continued to build global momentum and adapted to meet the needs of our customers,” Mahoney said. “Our strong business results reflect the winning spirit of our employees, diversification of our portfolio, focus on meaningful innovation, and globalization efforts.”

It must be mentioned that early 2016 saw the departure of a Boston Scientific legend. It was announced in late February that board chairman Peter Nicholas—who co-founded the company along with John Abele in 1979—would retire following the company’s annual stockholders meeting in May. Nicholas led Boston Scientific as CEO and co-chairman from its founding until 1995, when he stepped down and became chairman. Upon Nicholas’ retirement, the board appointed Mahoney as chairman.

Business Sector Activity
Boston Scientific’s medical device offerings are divided into seven units: Interventional Cardiology, Peripheral Interventions, Cardiac Rhythm Management, Electrophysiology, Endoscopy, Urology and Pelvic Health, and Neuromodulation. These units are grouped within three segments: Cardiovascular, Rhythm Management, and MEDSURG.

The Cardiovascular segment demonstrated an operational revenue growth of 9 percent in 2015. This segment contains the interventional cardiology and peripheral interventions portfolios, which grew in operational sales by 7 percent and 13 percent respectively. The revenue increase was largely a result of two factors: U.S. Food and Drug Administration approval of the SYNERGY bioabsorbable polymer drug-eluting stent system, which treats coronary artery disease, and the commercial launch of the WATCHMAN left atrial appendage closure device, which reduces stroke risk in eligible high-risk non-valvular atrial fibrillation patients. On the back end of 2015, the integration of Bayer AG’s interventional division grew shares of the atherectomy and thrombectomy sections.

The Rhythm Management segment exhibited a 1 percent operational and organic revenue increase in 2015, with the cardiac rhythm management and electrophysiology divisions growing 1 percent and 9 percent in operational sales, respectively. Revenue grew in pacemakers and implantable cardioverter-defibrillators (ICDs), with new, longer-lasting ICD batteries. Largely responsible for this increase were the market share gains from the EMBLEM subcutaneous implantable defibrillator in the United States and Europe, as well as the continued launch of the Rhythmia mapping and navigation system, which diagnoses and treats complex arrhythmias. The company’s portfolio of differentiated diagnostic and therapeutic catheters for electrophysiologists also continued to develop in 2015.

The MEDSURG section experienced an operational revenue growth of 13 percent in 2015. The endoscopy, urology and pelvic health, and neuromodulation divisions grew in operational sales by 6 percent, 36 percent, and 8 percent respectively, according to Boston Scientific’s 2015 annual report. The significant increase in urology and pelvic health sales results from the urology portfolio inherited from the acquisition of American Medical Systems’ (AMS) Men’s Health and Prostate Health businesses in August 2015. Growth in the endoscopy business was largely driven by the launch of the SpyGlass DS direct visualization system, used to diagnose and treat complex bile duct and pancreas disorders, as well as the transgastric or transduodenal drainage products gained through the April 2015 acquisition of Xlumena Inc. The neuromodulation business’ growth was largely attributed to sales of the Spectra spinal cord stimulation system, and global expansion of the company’s deep brain stimulation technologies for treatment of Parkinson’s, dystonia, and essential tremor.

Acquisitions and Alliances
Completed on Aug. 29, 2014, Boston Scientific’s acquisition of Bayer AG’s Interventional business continues to enhance the company’s ability to offer physicians and healthcare systems a more complete set of solutions to treat difficult vascular conditions. So far, the transaction has yielded the AngioJet thrombectomy system and the Fetch 2 aspiration catheter, both used to remove blood clots from arteries and veins during endovascular procedures. In 2015, the company continued to integrate Bayer’s operations with its peripheral interventions and interventional cardiology divisions, which was expected to be completed by mid-2016.

Furthering the company’s peripheral interventions sector, it completed the acquisition of CeloNova Biosciences’ interventional radiology business on Dec. 31, 2015, for a total of $70 million—adding additional payments based on regulatory and sales goals. The deal added drug-eluting microspheres for chemotherapeutic drug delivery to the company’s portfolio, as well as spherical embolic products to treat uterine fibroids, among other conditions.

The $1.6 billion acquisition of AMS’ male urology portfolio from Endo International plc has shown to be fruitful—operational sales in the urology and pelvic health division increased by 36 percent in 2015.  The division was formerly known as urology and women’s health, but was then changed to the gender-neutral urology and pelvic health to account for the company’s foray into male urology devices. The deal complimented Boston Scientific’s urology portfolio with such devices as the minimally invasive GreenLight XPS and HPS Laser Therapy Systems for treating benign prostatic hyperplasia, the AMS 800 Urinary Control System for male incontinence and the AMS 700 Inflatable Penile Prosthesis for erectile dysfunction.

Strengthening the company’s endoscopy division, Boston Scientific acquired Xlumena—developer of minimally invasive devices for endoscopic ultrasound-guided transluminal drainage of targeted GI tract areas. Boston Scientific executives said the move strengthens the company’s bid to become a market leader in the endoscopic ultrasound segment by coupling its Expect family of fine needle aspiration needles with the leader in therapeutic EUS.

Product News of Note Not particularly out of the ordinary, Boston Scientific Corp. received approval for and launched a number of new devices during 2015; globally, 75 new products made their respective debuts last year. The company achieved nearly 700 regulatory approvals and clearances worldwide for new products. Some of the more noteworthy are listed below: In early February, the company launched and announced the first U.S. implantation of its Extended Longevity (EL) ICDs, including both the DYNAGEN EL and INOGEN EL models. Through improved chemistry and manufacturing strategy, the battery technology claims to be capable of providing double the battery capacity of competing ICDs. In late February, Boston Scientific received 510(k) clearance for the SpyGlass DS direct visualization system, used for cholangioscopy and pancreatoscopy procedures. It builds on the original 2007 SpyGlass system, consisting of the SpyScope DS access and delivery catheter, a single-use scope, and an integrated digital sensor to allow a 60 percent wider field of view than the original system. In March, the U.S. Food and Drug Administration (FDA) approved the WATCHMAN left atrial appendage closure device. For high-risk patients with non-valvular atrial fibrillation looking for an alternative to long-term warfarin therapy, it reduces the risk of thromboembolism from the left atrial appendage. The first U.S. commercial procedures using the device occurred later that month. Also in March (apparently quite the busy month for the company), the EMBLEM S-ICD system received both FDA and CE mark approval. The product launched in Europe in May, and hit the U.S. market in June. The device provides protection for patients at risk of sudden cardiac arrest without touching the heart or surrounding vasculature. In June, the Precision Novi spinal cord stimulator system was launched in Europe. Powered by the company’s Illumina 3D software to target pain areas, the 16-contact primary cell device couples with a wireless remote to allow more personalized control over pain management. The FDA approved the Innova vascular expanding stent system in August. Comprised of a Nitinol self-expanding bare metal stent and delivery system, it provides treatment for peripheral artery disease. It is meant as a foundation for the company’s Eluvia drug-eluting vascular stent. In October, Boston Scientific was granted FDA approval for its SYNERGY bioabsorbable polymer drug-eluting stent system to treat coronary artery disease. It allows synchronized drug and polymer absorption, reducing risk of complications usually associated with long-term exposure to polymers, thereby facilitating rapid and complete arterial healing. Bearing more fruit from the Bayer AG acquisition, the AngioJet ZelanteDVT thrombectomy catheter received FDA and CE mark approval in November. It is designed to remove large venous clots and rapidly restore blood flow, with four times the thrombus (blood clot) removal strength of previous AngioJet catheters. It is intended to improve procedural efficiency associated with deep vein thrombosis (DVT). — S.B.