Timothy R. Ring, Chairman and CEO
John H. Weiland, President and Chief Operating Officer
Christopher S. Holland, Sr. VP, Chief Financial Officer
Samrat (“Sam”) S. Khichi, Sr. VP, General Counsel, and Secretary
Patricia G. Christian, VP, Quality, Regulatory, and Medical Affairs
John A. DeFord, Ph.D., Sr. VP, Science, Technology, and Clinical Affairs
Andrea J. Casper, VP, Regulatory Affairs
Todd W. Garner, VP, Investor Relations
Frank Lupisella Jr., VP, Controller
NUMBER OF EMPLOYEES: 14,900
GLOBAL HEADQUARTERS: Murray Hill, N.J.
Kicking off the year with focus, C.R. Bard rode the wave that crested at the end of 2014 with its U.S. Food and Drug Administration (FDA) approval of the Lutonix 035 drug coated balloon (DCB) catheter into 2015. In February last year, the company entered into a distribution agreement with Marlborough, Mass.-based Boston Scientific Corp. for the device, an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel, designed to decrease the incidence of restenosis and improve patency in patients with stenosed femoropopliteal vessels, often seen with peripheral artery disease. Boston Scientific won the right to distribute the balloon in the United States, which significantly expanded Bard’s reach.
C.R. Bard has had a good working relationship with Boston Scientific—in November 2013, Bard sold its electrophysiology division to the Massachusetts device company.
Later last year, Bard won a much coveted approval of expanded reimbursement for Lutonix from the U.S. Centers for Medicare and Medicaid Services (CMS). The purpose of the reimbursement is to cover additional costs to U.S. hospitals for treating Medicare beneficiaries with the Lutonix DCB in the outpatient setting. After further review, CMS determined that costs associated with DCBs were not included in existing reimbursement for percutaneous transluminal angioplasty, stenting, or atherectomy procedures. Therefore, CMS removed the device offset charge from the calculation and will reimburse the full cost of DCBs in these procedures. The reimbursement determination, which was granted in June, became retroactive to April 1, 2015.
Then in August, CMS approved a new technology add-on payment for Lutonix under the Medicare hospital inpatient prospective payment system. This time, the expanded coverage covered hospital costs for inpatient users of Lutonix.
Overall, 2015 was the year of Lutonix for C.R. Bard, culminating in a report of the 12-month results from the Lutonix Global Real-World Registry at the Transcatheter Cardiovascular Therapeutics (TCT) 2015 meeting. These results came just months after New England Journal of Medicine published one-year data from the Lutonix 35 DCB catheter pivotal, randomized LEVANT 2 trial. In this registry study, the Lutonix 035 DCB demonstrated a freedom from target lesion revascularization (TLR) rate of 94.3 percent in femoropopliteal arteries at 12 months in 631 patients. Based upon interim data from 170 patients (who were early enrollees), a freedom from TLR rate of 93 percent at 24 months was also achieved.
But did all this translate to cash? The short answer is yes; out of the four main product divisions at Bard—vascular, urology, oncology, and surgical specialties—vascular showed the biggest 2015 net sales growth at 9 percent. “To date, the results [of the first full year of selling Lutonix] have exceeded our expectations,” Chairman and CEO Timothy M. Ring, and President and Chief Operating Officer John H. Weiland said in the company’s 2015 annual report. “We are pursuing additional indications and variations on the platform that we anticipate will broaden its application even further.”
Also in 2015, Bard acquired Vascular Pathways Inc., a Boca Raton, Fla.-based developer and supplier of vascular access devices, and began to sell the Accucath intravenous catheter system. This, along with Bard’s peripherally inserted central catheters (PICCs) and Powerglide midline family, allowed the company to offer a comprehensive line of guidewire-assisted peripheral devices to a broad spectrum of patients with vascular access needs.
In January 2016—after fiscal year 2015 ended on Dec. 31—Bard acquired Stuart, Fla.-based Liberator Medical Holdings Inc., a direct-to-consumer distributor of durable medical equipment. The acquisition of Liberator enhances Bard’s access to the growing home care market—specifically for intermittent self-catheterization products—including the company’s recently introduced Magic3 Go self-lubricating catheter and Hydrosil Rose intermittent catheter, which is designed specifically for female patients. Bard is focusing on home health, which, according to Ring and Weiland, will become increasingly important as the aging population embraces healthcare in the home setting.
Based in Murray Hill, N.J., Bard’s 2015 acquisitions have given it a significant presence in Florida, which has a vibrant and growing medical device environment.
Bard didn’t experience many major personnel shifts in FY15, but it did slightly expand its board with the addition of Robert M. Davis, executive vice president and CEO of pharmaceutical giant Merck & Co. Inc. He serves on the Audit, Finance, and Science and Technology committees. While there were no changes to the senior management team, Bard did realign certain senior roles in order to facilitate company growth plans. John P. Groetelaars was promoted to group president and added Bard Access Systems to his existing responsibilities for Bard subsidiary Davol in China, Australia, New Zealand, and the rest of Asia. Timothy P. Collins, group president, added Bard Medical Division to his existing responsibilities for Worldwide Operations, Canada, Europe, Middle East and Africa, and South Africa. Jim C. Beasley, group president, assumed responsibility for subsidiary Medicon Inc. and for driving the new market development process across Bard to enable and accelerate its growth in new and developing markets. Beasley continues to be responsible for Latin America, Bard Peripheral Vascular, and Lutonix. Christopher S. Holland, senior vice president and chief financial officer, assumed responsibility for business development, corporate marketing, reimbursement, healthcare economics, and strategy.
Beasley’s charge of Medicon emerged from Bard’s acquisition of the company last year. Until 2015, Bard and Japanese firm Kobayashi Pharmaceutical Co. Ltd. had a 50-50 stake in Medicon, an Osaka, Japan-based joint venture that the two companies have operated together since 1972 through a share redemption. In September, the companies agreed that Bard would acquire Kobayashi’s share in the company. According to a statement from Bard, the company believes that future growth opportunities in Japan will come from more clinically differentiated market segments, including peripheral vascular and vascular access. Therefore, the company believes the time is ripe to take a more direct role with Japanese clinicians and patients.
Net sales grew 3 percent in 2015 over the previous year—$3.42 billion over $3.32 billion. As mentioned above, the vascular business performed best, helped along by the performance of Lutonix. Urology products comprised 25 percent of net sales: basic drainage product sales rose 4 percent on a constant currency basis; continence and urological specialties increased 2 and 1 percent respectively; and catheter stabilization products remained—pardon the pun—stable. Oncology products constituted 27 percent of net sales, with PICCs and midlines net sales growing a robust 11 percent over 2014. Under the surgical specialties business, which made up 17 percent of net sales, performance irrigation products took a nose dive, with a 28 percent decrease in sales on a constant currency basis.